id|nct_id|ctgov_group_code|result_type|title|description
262|NCT03163134|B3|Baseline|Total|Total of all reporting groups
263|NCT03163134|B2|Baseline|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery.
Lumbar Drain"
264|NCT03163134|B1|Baseline|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery.
265|NCT03163134|P2|Participant Flow|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery
Lumbar Drain"
266|NCT03163134|P1|Participant Flow|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery
267|NCT03163134|O2|Outcome|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery.
Lumbar Drain"
268|NCT03163134|O1|Outcome|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery.
269|NCT03163134|O2|Outcome|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery.
Lumbar Drain"
270|NCT03163134|O1|Outcome|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery.
271|NCT03163134|E2|Reported Event|Lumbar Drain Group|"Group of patients that received a lumbar drain after surgery
Lumbar Drain"
272|NCT03163134|E1|Reported Event|No Lumbar Drain Group|Group of patients that did not receive a lumbar drain after surgery
273|NCT03159143|B1|Baseline|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
274|NCT03159143|P1|Participant Flow|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
275|NCT03159143|O1|Outcome|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
276|NCT03159143|O1|Outcome|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
277|NCT03159143|O1|Outcome|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
278|NCT03159143|O1|Outcome|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
279|NCT03159143|E1|Reported Event|Docetaxel and Oxaliplatin|"Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2"
280|NCT03157232|B1|Baseline|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
281|NCT03157232|P1|Participant Flow|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
282|NCT03157232|O1|Outcome|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
283|NCT03157232|E1|Reported Event|Test Group|All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
284|NCT03134326|B1|Baseline|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
285|NCT03134326|P1|Participant Flow|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
286|NCT03134326|O1|Outcome|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
287|NCT03134326|E1|Reported Event|Test Group|All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors
288|NCT03134313|B1|Baseline|R1-25 Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor"
289|NCT03134313|P1|Participant Flow|R1-25 Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor"
290|NCT03134313|O1|Outcome|R1-25 Sensor|All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
291|NCT03134313|E1|Reported Event|R1-25 Sensor|All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
292|NCT03125031|B1|Baseline|Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors|All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal sensors).
293|NCT03125031|P2|Participant Flow|Rainbow Adhesive Adult/Neonatal Sensor|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
294|NCT03125031|P1|Participant Flow|Rainbow Adhesive Adult/Pediatric Sensor|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.
295|NCT03125031|O2|Outcome|Group-Sensor 2|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
296|NCT03125031|O1|Outcome|Group-Sensor 1|All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.
297|NCT03125031|E1|Reported Event|Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors|All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal).
298|NCT03125018|B1|Baseline|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
299|NCT03125018|P1|Participant Flow|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
300|NCT03125018|O1|Outcome|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
301|NCT03125018|E1|Reported Event|Test Subject|All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
302|NCT03125005|B1|Baseline|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.
Rainbow Universal Pulse Oximeter Sensor"
303|NCT03125005|P1|Participant Flow|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.
Rainbow Universal Pulse Oximeter Sensor"
304|NCT03125005|O1|Outcome|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.
Rainbow Universal Pulse Oximeter Sensor"
305|NCT03125005|E1|Reported Event|Rainbow Universal Pulse Oximeter Sensor|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.
Rainbow Universal Pulse Oximeter Sensor"
306|NCT03124979|B1|Baseline|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
307|NCT03124979|P1|Participant Flow|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
308|NCT03124979|O1|Outcome|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
309|NCT03124979|E1|Reported Event|Test Subject|All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
310|NCT03124966|B1|Baseline|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
311|NCT03124966|P1|Participant Flow|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
312|NCT03124966|O1|Outcome|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
313|NCT03124966|E1|Reported Event|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
314|NCT03124927|B1|Baseline|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
315|NCT03124927|P1|Participant Flow|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
316|NCT03124927|O1|Outcome|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
317|NCT03124927|E1|Reported Event|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
318|NCT03124901|B1|Baseline|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
319|NCT03124901|P1|Participant Flow|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
320|NCT03124901|O1|Outcome|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
321|NCT03124901|E1|Reported Event|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
322|NCT03124836|B1|Baseline|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor
Pulse Oximeter Sensor"
323|NCT03124836|P1|Participant Flow|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor
Pulse Oximeter Sensor"
324|NCT03124836|O1|Outcome|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor
Pulse Oximeter Sensor"
325|NCT03124836|E1|Reported Event|R2-25 Sensor|"All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor
Pulse Oximeter Sensor"
326|NCT03124823|B1|Baseline|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
327|NCT03124823|P1|Participant Flow|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
328|NCT03124823|O1|Outcome|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
329|NCT03124823|E1|Reported Event|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
330|NCT03124797|B1|Baseline|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
331|NCT03124797|P1|Participant Flow|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
332|NCT03124797|O1|Outcome|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
1056|NCT02964767|B1|Baseline|1.HIV|patients with mono HIV infections
333|NCT03124797|E1|Reported Event|RD DCI Sensor|All subjects are enrolled into the test group and all subjects received the RD DCI Sensor
334|NCT03124771|B1|Baseline|Rainbow Resposable Adhesive Sensors|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
335|NCT03124771|P1|Participant Flow|Rainbow Resposable Adhesive Sensor|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
336|NCT03124771|O1|Outcome|Rainbow Resposable Adhesive Sensor|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
337|NCT03124771|E1|Reported Event|Rainbow Resposable Adhesive Sensor|All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
338|NCT03124758|B1|Baseline|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
339|NCT03124758|P1|Participant Flow|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
340|NCT03124758|O1|Outcome|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
341|NCT03124758|E1|Reported Event|Noninvasive Hemoglobin Sensor|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
342|NCT03124693|B1|Baseline|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.
Rainbow DCI pulse oximeter sensor"
343|NCT03124693|P1|Participant Flow|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.
Rainbow DCI pulse oximeter sensor"
344|NCT03124693|O1|Outcome|Test Group|All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.
345|NCT03124693|E1|Reported Event|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.
Rainbow DCI pulse oximeter sensor"
346|NCT03119831|B4|Baseline|Total|Total of all reporting groups
347|NCT03119831|B3|Baseline|Group C|"Alcoholic Chlorhexidine Gluconate 0.12%
Alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
348|NCT03119831|B2|Baseline|Group B|"Non-alcoholic Chlorhexidine Gluconate 0.12%
Non-alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
349|NCT03119831|B1|Baseline|Group A|"C31G
C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
350|NCT03119831|P3|Participant Flow|Alcohol-based Chlorhexidine (Group C)|"Alcohol-based Chlorhexidine Gluconate 0.12%
Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
351|NCT03119831|P2|Participant Flow|Alcohol-free Chlorhexidine (Group B)|"Alcohol-free Chlorhexidine Gluconate 0.12%
Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
352|NCT03119831|P1|Participant Flow|C31G (Group A)|"C31G
C31G: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
353|NCT03119831|O3|Outcome|Group C|"Alcohol-based Chlorhexidine Gluconate 0.12%
Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
354|NCT03119831|O2|Outcome|Group B|"Alcohol-free Chlorhexidine Gluconate 0.12%
Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
355|NCT03119831|O1|Outcome|Group A|"C31G
C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
356|NCT03119831|O3|Outcome|Group C|"Alcohol-based Chlorhexidine Gluconate 0.12%
Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
357|NCT03119831|O2|Outcome|Group B|"Alcohol-free Chlorhexidine Gluconate 0.12%
Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
358|NCT03119831|O1|Outcome|Group A|"C31G
C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
359|NCT03119831|O3|Outcome|Group C|"Alcohol-based Chlorhexidine Gluconate 0.12%
Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
360|NCT03119831|O2|Outcome|Group B|"Alcohol-free Chlorhexidine Gluconate 0.12%
Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
361|NCT03119831|O1|Outcome|Group A|"C31G
C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
362|NCT03119831|O3|Outcome|Group C|"Alcohol-based Chlorhexidine Gluconate 0.12%
Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
363|NCT03119831|O2|Outcome|Group B|"Alcohol-free Chlorhexidine Gluconate 0.12%
Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
364|NCT03119831|O1|Outcome|Group A|"C31G
C31G: Rinsing with 15ml for one minute twice daily for 14 days postoperatively"
365|NCT03119831|E3|Reported Event|Group C|"Alcoholic Chlorhexidine Gluconate 0.12%
Alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
366|NCT03119831|E2|Reported Event|Group B|"Non-alcoholic Chlorhexidine Gluconate 0.12%
Non-alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
367|NCT03119831|E1|Reported Event|Group A|"C31G
C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically"
368|NCT03115853|B1|Baseline|All Participants|
369|NCT03115853|P1|Participant Flow|All Participants|all participants enrolled in the study
370|NCT03115853|O3|Outcome|HCTZ and Placebo|HCTZ 25 mg po plus Placebo.
371|NCT03115853|O2|Outcome|HCTZ Plus Aliskiren 300mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
372|NCT03115853|O1|Outcome|HCTZ Plus Aliskiren 150mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
373|NCT03115853|O3|Outcome|HCTZ and Placebo|HCTZ 25 mg po plus Placebo.
1057|NCT02964767|P2|Participant Flow|HIV/Tb.|Patients with HIV/Tb. co infection
374|NCT03115853|O2|Outcome|HCTZ Plus Aliskiren 300mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
375|NCT03115853|O1|Outcome|HCTZ Plus Aliskiren 150mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
376|NCT03115853|O3|Outcome|HCTZ and Placebo|HCTZ 25 mg po plus Placebo.
377|NCT03115853|O2|Outcome|HCTZ Plus Aliskiren 300mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
378|NCT03115853|O1|Outcome|HCTZ Plus Aliskiren 150mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
379|NCT03115853|O3|Outcome|HCTZ and Placebo|HCTZ 25 mg po plus Placebo.
380|NCT03115853|O2|Outcome|HCTZ Plus Aliskiren 300mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
381|NCT03115853|O1|Outcome|HCTZ Plus Aliskiren 150mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
382|NCT03115853|O3|Outcome|HCTZ and Placebo|HCTZ 25 mg po plus Placebo.
383|NCT03115853|O2|Outcome|HCTZ Plus Aliskiren 300mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
384|NCT03115853|O1|Outcome|HCTZ Plus Aliskiren 150mg|HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
385|NCT03115853|E1|Reported Event|All Participants|
386|NCT03106870|B3|Baseline|Total|Total of all reporting groups
387|NCT03106870|B2|Baseline|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
388|NCT03106870|B1|Baseline|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
389|NCT03106870|P2|Participant Flow|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
390|NCT03106870|P1|Participant Flow|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
391|NCT03106870|O2|Outcome|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
392|NCT03106870|O1|Outcome|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
393|NCT03106870|O2|Outcome|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
394|NCT03106870|O1|Outcome|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
395|NCT03106870|O2|Outcome|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
396|NCT03106870|O1|Outcome|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
397|NCT03106870|E2|Reported Event|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
422|NCT03073798|E1|Reported Event|All Participants|"Subjects underwent baseline MCC, then first received Roflumilast 500 mcg daily for 4 weeks. After a washout period of 4 weeks, they then received Placebo 500 mcg for an additional 4 weeks.
MCC was conducted at baseline and at the end of each 4 week medication phase."
423|NCT03072719|B3|Baseline|Total|Total of all reporting groups
789|NCT03022435|O5|Outcome|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
398|NCT03106870|E1|Reported Event|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
Insulin Mixtard: Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
399|NCT03106337|B1|Baseline|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
400|NCT03106337|P1|Participant Flow|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
401|NCT03106337|O2|Outcome|Shear-Wave Elastography, Malignant Lesions|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort Includes all participants with malignant lesions.
402|NCT03106337|O1|Outcome|Shear-Wave Elastography, Benign Lesions|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort includes all participants with benign lesions.
403|NCT03106337|E1|Reported Event|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
404|NCT03091751|B1|Baseline|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.
BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
405|NCT03091751|P1|Participant Flow|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.
BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
406|NCT03091751|O1|Outcome|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.
BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
407|NCT03091751|O1|Outcome|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.
BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
408|NCT03091751|O1|Outcome|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.
BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
409|NCT03091751|O1|Outcome|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.
BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
410|NCT03091751|O1|Outcome|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.
BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
411|NCT03091751|E1|Reported Event|BeneFIX|"BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.
BeneFIX: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg."
412|NCT03073798|B1|Baseline|All Participants|"Roflumilast. 500 mcg of Roflumilast daily for 4 weeks, then there will be a 4 week wash-out phase (no medication) and a second 4 week period of placebo.
Roflumilast: 500 mcg of Roflumilast which is a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms
Placebo: 500 mcg of placebo is used"
413|NCT03073798|P1|Participant Flow|All Participants|Subjects underwent baseline MCC, then first received Roflumilast 500 mcg daily for 4 weeks. After a washout period of 4 weeks, they then received Placebo 500 mcg for an additional 4 weeks.
414|NCT03073798|O2|Outcome|All Placebo MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
415|NCT03073798|O1|Outcome|All Roflumilast MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.
416|NCT03073798|O2|Outcome|All Placebo MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
417|NCT03073798|O1|Outcome|All Roflumilast MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.
418|NCT03073798|O2|Outcome|All Placebo MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
419|NCT03073798|O1|Outcome|All Roflumilast MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.
420|NCT03073798|O2|Outcome|All Placebo MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
421|NCT03073798|O1|Outcome|All Roflumilast MCC|Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.
588|NCT03055221|P1|Participant Flow|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
424|NCT03072719|B2|Baseline|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
425|NCT03072719|B1|Baseline|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
426|NCT03072719|P2|Participant Flow|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
427|NCT03072719|P1|Participant Flow|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100 parts per million [ppm] as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
428|NCT03072719|O2|Outcome|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
429|NCT03072719|O1|Outcome|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
430|NCT03072719|O2|Outcome|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
431|NCT03072719|O1|Outcome|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
432|NCT03072719|O2|Outcome|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
433|NCT03072719|O1|Outcome|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
434|NCT03072719|E2|Reported Event|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
435|NCT03072719|E1|Reported Event|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
436|NCT03070730|B4|Baseline|Total|Total of all reporting groups
437|NCT03070730|B3|Baseline|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
438|NCT03070730|B2|Baseline|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
439|NCT03070730|B1|Baseline|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
440|NCT03070730|P3|Participant Flow|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
441|NCT03070730|P2|Participant Flow|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
442|NCT03070730|P1|Participant Flow|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
589|NCT03055221|O1|Outcome|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
790|NCT03022435|O4|Outcome|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
443|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
444|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
445|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
446|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
447|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
448|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
449|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
450|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
451|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
452|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
453|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
454|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
455|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
456|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
457|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
590|NCT03055221|O1|Outcome|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
681|NCT03035955|B2|Baseline|Azelaic Acid Right/No Treatment Left|azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face
458|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
459|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
460|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
461|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
462|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
463|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
464|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
465|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
466|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
467|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
468|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
469|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
470|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
471|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
472|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
591|NCT03055221|E1|Reported Event|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
592|NCT03048383|B4|Baseline|Total|Total of all reporting groups
791|NCT03022435|O3|Outcome|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
473|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
474|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
475|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
476|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
477|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
478|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
479|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
480|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
481|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
482|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
483|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
484|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
485|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
486|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
487|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
593|NCT03048383|B3|Baseline|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
488|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
489|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
490|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
491|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
492|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
493|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
494|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
495|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
496|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
497|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
498|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
499|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
500|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
501|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
502|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
594|NCT03048383|B2|Baseline|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
503|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
504|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
505|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
506|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
507|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
508|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
509|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
510|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
511|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
512|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
513|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
514|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
515|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
516|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
517|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
595|NCT03048383|B1|Baseline|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
518|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
519|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
520|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
521|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
522|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
523|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
524|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
525|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
526|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
527|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
528|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
529|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
530|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
531|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
532|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
596|NCT03048383|P3|Participant Flow|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
533|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
534|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
535|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
536|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
537|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
538|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
539|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
540|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
541|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
542|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
543|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
544|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
545|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
546|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
547|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
597|NCT03048383|P2|Participant Flow|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
548|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
549|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
550|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
551|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
552|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
553|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
554|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
555|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
556|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
557|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
558|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
559|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
560|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
561|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
562|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
598|NCT03048383|P1|Participant Flow|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
563|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
564|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
565|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
566|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
567|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
568|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
569|NCT03070730|E3|Reported Event|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
570|NCT03070730|E2|Reported Event|Placebos|"In this arm subjects are randomized to placebo tid.
Placebo is used to control the administration effect.
Placebos: Placebo: t.i.d"
571|NCT03070730|E1|Reported Event|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.
Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.
Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d
Atenolol: Atenolol: 50 mg Q.D.
Placebos: Placebo: t.i.d"
572|NCT03065933|B1|Baseline|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.
extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
573|NCT03065933|P1|Participant Flow|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.
extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
574|NCT03065933|O1|Outcome|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.
extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
575|NCT03065933|E1|Reported Event|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.
extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
576|NCT03061513|B3|Baseline|Total|Total of all reporting groups
577|NCT03061513|B2|Baseline|Placebo|"Placebo daily for 24 weeks
Placebo: placebo"
578|NCT03061513|B1|Baseline|Ubiquinol|"600mg ubiquinol daily for 24 weeks
Ubiquinol: Ubiquinol caplets 600mg/day"
579|NCT03061513|P2|Participant Flow|Placebo|"Placebo daily for 24 weeks
Placebo: placebo"
580|NCT03061513|P1|Participant Flow|Ubiquinol|"600mg ubiquinol daily for 24 weeks
Ubiquinol: Ubiquinol caplets 600mg/day"
581|NCT03061513|O2|Outcome|Placebo|"Placebo daily for 24 weeks
Placebo: placebo"
582|NCT03061513|O1|Outcome|Ubiquinol|"600mg ubiquinol daily for 24 weeks
Ubiquinol: Ubiquinol caplets 600mg/day"
583|NCT03061513|O2|Outcome|Placebo|"Placebo daily for 24 weeks
Placebo: placebo"
584|NCT03061513|O1|Outcome|Ubiquinol|"600mg ubiquinol daily for 24 weeks
Ubiquinol: Ubiquinol caplets 600mg/day"
585|NCT03061513|E2|Reported Event|Placebo|"Placebo daily for 24 weeks
Placebo: placebo"
586|NCT03061513|E1|Reported Event|Ubiquinol|"600mg ubiquinol daily for 24 weeks
Ubiquinol: Ubiquinol caplets 600mg/day"
587|NCT03055221|B1|Baseline|Intravenous Treprostinil|"Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration."
599|NCT03048383|O3|Outcome|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
600|NCT03048383|O2|Outcome|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
601|NCT03048383|O1|Outcome|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
602|NCT03048383|O3|Outcome|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
603|NCT03048383|O2|Outcome|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
604|NCT03048383|O1|Outcome|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
605|NCT03048383|E3|Reported Event|Incobotulinumtoxin A Injectable Product|"incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
Incobotulinumtoxin A Injectable Product: Administered to treat facial synkinesis"
606|NCT03048383|E2|Reported Event|AbobotulinumtoxinA Injectable Product|"abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
AbobotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
607|NCT03048383|E1|Reported Event|OnabotulinumtoxinA Injectable Product|"onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
OnabotulinumtoxinA Injectable Product: Administered to treat facial synkinesis"
608|NCT03048006|B1|Baseline|All Included Patients|All included patients underwent MRI with Dotarem
609|NCT03048006|P1|Participant Flow|All Included Patients|All included patients underwent MRI with Dotarem
610|NCT03048006|O1|Outcome|All Included Patients|All included patients underwent MRI with Dotarem
611|NCT03048006|O1|Outcome|All Included Patients|All included patients underwent MRI with Dotarem
612|NCT03048006|O1|Outcome|All Included Patients|All included patients underwent MRI with Dotarem
613|NCT03048006|E1|Reported Event|All Included Patients|All included patients underwent MRI with Dotarem
614|NCT03047447|B4|Baseline|Total|Total of all reporting groups
615|NCT03047447|B3|Baseline|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
616|NCT03047447|B2|Baseline|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
617|NCT03047447|B1|Baseline|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
644|NCT03043534|O2|Outcome|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
682|NCT03035955|B1|Baseline|Azelaic Acid Left/No Treatment Right|azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face
618|NCT03047447|P3|Participant Flow|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
619|NCT03047447|P2|Participant Flow|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
620|NCT03047447|P1|Participant Flow|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
621|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
622|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
624|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
625|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
626|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
627|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
628|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
629|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
1058|NCT02964767|P1|Participant Flow|HIV,|HIV mono infected patients,
630|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.
p=.211"
631|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.
p=0.11"
632|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.
p=0.00"
633|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.
p=.211"
634|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.
p=0.11"
635|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.
p=0.00"
636|NCT03047447|E3|Reported Event|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
637|NCT03047447|E2|Reported Event|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
638|NCT03047447|E1|Reported Event|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.
Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
639|NCT03043534|B3|Baseline|Total|Total of all reporting groups
640|NCT03043534|B2|Baseline|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
641|NCT03043534|B1|Baseline|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE
Brush: All subjects randomized to brush will use the brush with each shave"
642|NCT03043534|P2|Participant Flow|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
643|NCT03043534|P1|Participant Flow|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE
Brush: All subjects randomized to brush will use the brush with each shave"
645|NCT03043534|O1|Outcome|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE
Brush: All subjects randomized to brush will use the brush with each shave"
646|NCT03043534|O2|Outcome|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
647|NCT03043534|O1|Outcome|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE
Brush: All subjects randomized to brush will use the brush with each shave"
648|NCT03043534|E2|Reported Event|Control|Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
649|NCT03043534|E1|Reported Event|Gel and Brush|"The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE
Brush: All subjects randomized to brush will use the brush with each shave"
650|NCT03041298|B1|Baseline|All Included Patients|All included patients underwent MR mammography with Dotarem.
651|NCT03041298|P1|Participant Flow|All Included Patients|All included patients underwent MR mammography with Dotarem.
652|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
653|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
654|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
655|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
656|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
657|NCT03041298|E1|Reported Event|All Included Patients|All included patients underwent MR mammography with Dotarem.
658|NCT03039179|B3|Baseline|Total|Total of all reporting groups
659|NCT03039179|B2|Baseline|Standard Care|
660|NCT03039179|B1|Baseline|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
661|NCT03039179|P2|Participant Flow|Standard Care|Only application of the Walker in the immediate postoperative period.
662|NCT03039179|P1|Participant Flow|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
663|NCT03039179|O2|Outcome|Standard Care|
664|NCT03039179|O1|Outcome|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
665|NCT03039179|O2|Outcome|Standard Care|
666|NCT03039179|O1|Outcome|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
667|NCT03039179|E2|Reported Event|Standard Care|
668|NCT03039179|E1|Reported Event|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
669|NCT03037541|B3|Baseline|Total|Total of all reporting groups
670|NCT03037541|B2|Baseline|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
671|NCT03037541|B1|Baseline|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week
Carac Cream: Carac Cream will be used once daily for seven consecutive days"
672|NCT03037541|P2|Participant Flow|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
673|NCT03037541|P1|Participant Flow|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week
Carac Cream: Carac Cream will be used once daily for seven consecutive days"
674|NCT03037541|O2|Outcome|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
675|NCT03037541|O1|Outcome|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week
Carac Cream: Carac Cream will be used once daily for seven consecutive days"
676|NCT03037541|O2|Outcome|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
677|NCT03037541|O1|Outcome|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week
Carac Cream: Carac Cream will be used once daily for seven consecutive days"
678|NCT03037541|E2|Reported Event|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
679|NCT03037541|E1|Reported Event|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week
Carac Cream: Carac Cream will be used once daily for seven consecutive days"
680|NCT03035955|B3|Baseline|Total|Total of all reporting groups
683|NCT03035955|P2|Participant Flow|Azelaic Acid Right/No Treatment Left|"azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face
Azelaic acid: 15% gel twice daily for four weeks to the right side of face"
684|NCT03035955|P1|Participant Flow|Azelaic Acid Left/No Treatment Right|"azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face
Azelaic acid: 15% gel twice daily for four weeks to the left side of face"
685|NCT03035955|O2|Outcome|Azelaic Acid Right /no Treatment Left|azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face
686|NCT03035955|O1|Outcome|Azelaic Acid Left/no Treatment Right|azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face
687|NCT03035955|E2|Reported Event|no Treatment|no treatment on the other side of the face
688|NCT03035955|E1|Reported Event|Azelaic Acid|"azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face
Azelaic acid: 15% gel twice daily for four weeks to one side of face"
689|NCT03026803|B1|Baseline|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14
Oxaliplatin: Given IV
Capecitabine: Given PO"
690|NCT03026803|P1|Participant Flow|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14
Oxaliplatin: Given IV
Capecitabine: Given PO"
691|NCT03026803|O1|Outcome|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14
Oxaliplatin: Given IV
Capecitabine: Given PO"
692|NCT03026803|E1|Reported Event|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14
Oxaliplatin: Given IV
Capecitabine: Given PO"
693|NCT03023709|B3|Baseline|Total|Total of all reporting groups
694|NCT03023709|B2|Baseline|Study Phase (LAIV4)|"Participants will be given quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
695|NCT03023709|B1|Baseline|Pilot Phase (IIV4)|"Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
696|NCT03023709|P2|Participant Flow|Study Phase (LAIV4)|"Participants will be given the quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
697|NCT03023709|P1|Participant Flow|Pilot Phase (IIV4)|"Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering licensed seasonal influenza vaccine 3-14 days prior to tonsillectomy.
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
698|NCT03023709|O2|Outcome|Study Phase (LAIV4)|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
699|NCT03023709|O1|Outcome|Pilot Phase (IIV4)|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
700|NCT03023709|O2|Outcome|Study Phase|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
701|NCT03023709|O1|Outcome|Pilot Phase|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
702|NCT03023709|E2|Reported Event|Study Phase (LAIV4)|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
703|NCT03023709|E1|Reported Event|Pilot Phase (IIV4)|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
704|NCT03023683|B3|Baseline|Total|Total of all reporting groups
705|NCT03023683|B2|Baseline|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
706|NCT03023683|B1|Baseline|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
707|NCT03023683|P2|Participant Flow|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
708|NCT03023683|P1|Participant Flow|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
709|NCT03023683|O2|Outcome|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
710|NCT03023683|O1|Outcome|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
711|NCT03023683|O2|Outcome|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
712|NCT03023683|O1|Outcome|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
713|NCT03023683|E2|Reported Event|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
714|NCT03023683|E1|Reported Event|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
715|NCT03023553|B3|Baseline|Total|Total of all reporting groups
716|NCT03023553|B2|Baseline|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
717|NCT03023553|B1|Baseline|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
718|NCT03023553|P2|Participant Flow|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
719|NCT03023553|P1|Participant Flow|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
720|NCT03023553|O2|Outcome|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
721|NCT03023553|O1|Outcome|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
722|NCT03023553|O2|Outcome|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
723|NCT03023553|O1|Outcome|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
724|NCT03023553|E2|Reported Event|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
725|NCT03023553|E1|Reported Event|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
726|NCT03023488|B1|Baseline|Flexible Ureteroscopy Arm|"findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
727|NCT03023488|P1|Participant Flow|Flexible Ureteroscopy Arm|"Doppler Ultrasound examination was performed in both the pre-operative and post-operative periods on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
728|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The number of patients who had a complication after the flexible ureteroscopy operation in the first month following the operation.
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
729|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The number of patients that had a complication intraoperatively.
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
1059|NCT02964767|O2|Outcome|2.HIV/Tb.|Patients with HIV/Tb. co infections
730|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The pressure applied to the irrigation solution during a flexible ureteroscopy operation
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
731|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The duration of the flexible ureteroscopy operation
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
732|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The type of the ureteroscope used for the flexible ureteroscopy operation
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
733|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
734|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
735|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
736|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
737|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
1060|NCT02964767|O1|Outcome|1.HIV|HIV patients only
738|NCT03023488|E1|Reported Event|Flexible Ureteroscopy Arm|"findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
739|NCT03023176|B1|Baseline|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.
Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection
Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
740|NCT03023176|P1|Participant Flow|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.
Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection
Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
741|NCT03023176|O1|Outcome|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.
Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection
Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
742|NCT03023176|O1|Outcome|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.
Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection
Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
743|NCT03023176|E1|Reported Event|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.
Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection
Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
744|NCT03023137|B3|Baseline|Total|Total of all reporting groups
745|NCT03023137|B2|Baseline|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
746|NCT03023137|B1|Baseline|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrolment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water or sugar-sweetened beverages. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
747|NCT03023137|P2|Participant Flow|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
748|NCT03023137|P1|Participant Flow|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
749|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
750|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
751|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
785|NCT03022435|O4|Outcome|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
786|NCT03022435|O3|Outcome|Group D: 40 - 64 yo Identical Twins|Participants to receive Fluzone® standard TIV
2848|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
752|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
753|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
754|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
755|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
756|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
757|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
758|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
759|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
760|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
761|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
762|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
763|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
787|NCT03022435|O2|Outcome|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
788|NCT03022435|O1|Outcome|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray
764|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
765|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
766|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
767|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
768|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
769|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
770|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
771|NCT03023137|E2|Reported Event|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
772|NCT03023137|E1|Reported Event|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet will be given to participants assigned to W&D at enrollment and at each consultation.
Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.
2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
773|NCT03022435|B6|Baseline|Total|Total of all reporting groups
774|NCT03022435|B5|Baseline|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
775|NCT03022435|B4|Baseline|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
776|NCT03022435|B3|Baseline|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
777|NCT03022435|B2|Baseline|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
778|NCT03022435|B1|Baseline|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
779|NCT03022435|P5|Participant Flow|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
780|NCT03022435|P4|Participant Flow|Group F: 65-100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
781|NCT03022435|P3|Participant Flow|Group D: 40 - 64 yo Identical Twins|Participants to receive Fluzone® standard TIV
782|NCT03022435|P2|Participant Flow|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
783|NCT03022435|P1|Participant Flow|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
784|NCT03022435|O5|Outcome|Group F: 65 - 100 yo Identical Twins (High Dose TIV)|Participants to receive High-Dose Fluzone® standardTIV
792|NCT03022435|O2|Outcome|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
793|NCT03022435|O1|Outcome|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
794|NCT03022435|E5|Reported Event|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
795|NCT03022435|E4|Reported Event|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
796|NCT03022435|E3|Reported Event|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
797|NCT03022435|E2|Reported Event|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
798|NCT03022435|E1|Reported Event|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
799|NCT03022422|B7|Baseline|Total|Total of all reporting groups
800|NCT03022422|B6|Baseline|Group F: 65-100 yo Identical Twins (High-DoseTIV)|Individual twins will receive Fluzone® high-dose TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
801|NCT03022422|B5|Baseline|Group F: 65-100 yo Identical Twins (TIV)|Individual twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
802|NCT03022422|B4|Baseline|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
803|NCT03022422|B3|Baseline|Group D: 40-64 yo Identical Twins (TIV)|"Individual twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
804|NCT03022422|B2|Baseline|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
805|NCT03022422|B1|Baseline|Group B: 18-30 yo Identical Twins (TIV)|"Individual twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
806|NCT03022422|P6|Participant Flow|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
807|NCT03022422|P5|Participant Flow|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
808|NCT03022422|P4|Participant Flow|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
809|NCT03022422|P3|Participant Flow|Group D: 40-64 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
810|NCT03022422|P2|Participant Flow|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
811|NCT03022422|P1|Participant Flow|Group B: 18-30 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
812|NCT03022422|O6|Outcome|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
813|NCT03022422|O5|Outcome|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
814|NCT03022422|O4|Outcome|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
815|NCT03022422|O3|Outcome|Group D: 40-64 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
816|NCT03022422|O2|Outcome|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
817|NCT03022422|O1|Outcome|Group B: 18-30 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
818|NCT03022422|O6|Outcome|Group F: 65-100 yo Identical Twins (High-DoseTIV)|Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
819|NCT03022422|O5|Outcome|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
820|NCT03022422|O4|Outcome|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
821|NCT03022422|O3|Outcome|Group D: 40-64 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
822|NCT03022422|O2|Outcome|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
823|NCT03022422|O1|Outcome|Group B: 18-30 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
824|NCT03022422|E6|Reported Event|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Participants will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
825|NCT03022422|E5|Reported Event|Group F: 65-100 yo Identical Twins (TIV)|Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
826|NCT03022422|E4|Reported Event|Group E: 40-64 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
827|NCT03022422|E3|Reported Event|Group D: 40-64 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
828|NCT03022422|E2|Reported Event|Group C: 18-30 yo Fraternal Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
829|NCT03022422|E1|Reported Event|Group B: 18-30 yo Identical Twins (TIV)|"Individual Twins to receive Fluzone® standard TIV
Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
830|NCT03022396|B7|Baseline|Total|Total of all reporting groups
831|NCT03022396|B6|Baseline|Group F: Age 70 - 100 yo Twins|"Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
832|NCT03022396|B5|Baseline|Group E: Age 40 - 59 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
833|NCT03022396|B4|Baseline|Group D: Age 40 - 59 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
834|NCT03022396|B3|Baseline|Group C: Age 18-30 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
835|NCT03022396|B2|Baseline|Group B: Age 18-30 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
836|NCT03022396|B1|Baseline|Group A: Age 8-17 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
837|NCT03022396|P6|Participant Flow|Group F: Age 70 - 100 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
838|NCT03022396|P5|Participant Flow|Group E: Age 40 - 59 yo Fraternal Twins|"Individual Twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
839|NCT03022396|P4|Participant Flow|Group D: Age 40 - 59 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
840|NCT03022396|P3|Participant Flow|Group C: Age 18-30 yo Fraternal Twins|"Individual Twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
841|NCT03022396|P2|Participant Flow|Group B: Age 18-30 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
842|NCT03022396|P1|Participant Flow|Group A: Age 8-17 yo Identical Twins|"Individual Twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
843|NCT03022396|O6|Outcome|Group F: Age 70 - 100 yo Twins|"Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
844|NCT03022396|O5|Outcome|Group E: Age 40 - 59 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
845|NCT03022396|O4|Outcome|Group D: Age 40 - 59 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
846|NCT03022396|O3|Outcome|Group C: Age 18-30 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
847|NCT03022396|O2|Outcome|Group B: Age 18-30 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
848|NCT03022396|O1|Outcome|Group A: Age 8-17 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
849|NCT03022396|O6|Outcome|Group F: Age 70 - 100 yo Twins|"Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
850|NCT03022396|O5|Outcome|Group E: Age 40 - 59 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
851|NCT03022396|O4|Outcome|Group D: Age 40 - 59 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
852|NCT03022396|O3|Outcome|Group C: Age 18-30 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
853|NCT03022396|O2|Outcome|Group B: Age 18-30 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
854|NCT03022396|O1|Outcome|Group A: Age 8-17 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
855|NCT03022396|E6|Reported Event|Group F: Age 70 - 100 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular) or High-Dose Fluzone® (intramuscular)
High-Dose Fluzone® (intramuscular): Licensed seasonal High-Dose trivalent inactivated influenza
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
856|NCT03022396|E5|Reported Event|Group E: Age 40 - 59 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
857|NCT03022396|E4|Reported Event|Group D: Age 40 - 59 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
858|NCT03022396|E3|Reported Event|Group C: Age 18-30 yo Fraternal Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
859|NCT03022396|E2|Reported Event|Group B: Age 18-30 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
860|NCT03022396|E1|Reported Event|Group A: Age 8-17 yo Identical Twins|"Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza"
861|NCT03020537|B3|Baseline|Total|Total of all reporting groups
862|NCT03020537|B2|Baseline|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
863|NCT03020537|B1|Baseline|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
864|NCT03020537|P2|Participant Flow|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
865|NCT03020537|P1|Participant Flow|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
866|NCT03020537|O2|Outcome|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
867|NCT03020537|O1|Outcome|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
868|NCT03020537|O2|Outcome|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
869|NCT03020537|O1|Outcome|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
870|NCT03020537|E2|Reported Event|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
871|NCT03020537|E1|Reported Event|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
872|NCT03020498|B4|Baseline|Total|Total of all reporting groups
873|NCT03020498|B3|Baseline|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
874|NCT03020498|B2|Baseline|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
875|NCT03020498|B1|Baseline|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
876|NCT03020498|P3|Participant Flow|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
877|NCT03020498|P2|Participant Flow|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
878|NCT03020498|P1|Participant Flow|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
879|NCT03020498|O3|Outcome|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
880|NCT03020498|O2|Outcome|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
881|NCT03020498|O1|Outcome|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
882|NCT03020498|O3|Outcome|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
883|NCT03020498|O2|Outcome|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
2637|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
884|NCT03020498|O1|Outcome|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
885|NCT03020498|E3|Reported Event|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
886|NCT03020498|E2|Reported Event|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
887|NCT03020498|E1|Reported Event|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
888|NCT03020472|B1|Baseline|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
889|NCT03020472|P1|Participant Flow|2008-2009 FluMist LAIV (Intranasal)|"Seasonal live, attenuated influenza vaccine (LAIV)
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
890|NCT03020472|O1|Outcome|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
891|NCT03020472|O1|Outcome|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
892|NCT03020472|O1|Outcome|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
893|NCT03020472|E1|Reported Event|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
894|NCT03019783|B3|Baseline|Total|Total of all reporting groups
895|NCT03019783|B2|Baseline|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.
Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
896|NCT03019783|B1|Baseline|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.
Placebo: The control group will stay on their baseline regimen"
897|NCT03019783|P2|Participant Flow|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.
Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
898|NCT03019783|P1|Participant Flow|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.
Placebo: The control group will stay on their baseline regimen"
899|NCT03019783|O2|Outcome|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.
Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
900|NCT03019783|O1|Outcome|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.
Placebo: The control group will stay on their baseline regimen"
901|NCT03019783|O2|Outcome|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.
Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
902|NCT03019783|O1|Outcome|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.
Placebo: The control group will stay on their baseline regimen"
903|NCT03019783|E2|Reported Event|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.
Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
904|NCT03019783|E1|Reported Event|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.
Placebo: The control group will stay on their baseline regimen"
905|NCT03001674|B3|Baseline|Total|Total of all reporting groups
906|NCT03001674|B2|Baseline|Control|Conductance catheterization: CD Leycom Conductance Catheter
907|NCT03001674|B1|Baseline|IABP Recipient|Conductance catheterization: CD Leycom Conductance Catheter
908|NCT03001674|P2|Participant Flow|Control Group|Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
909|NCT03001674|P1|Participant Flow|IABP Recipient|"Prospective, double-arm, pilot study.
Conductance catheterization: CD Leycom Conductance Catheter"
910|NCT03001674|O2|Outcome|Control|"Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
Conductance catheterization: CD Leycom Conductance Catheter"
911|NCT03001674|O1|Outcome|IABP Recipient|"Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.
Conductance catheterization: CD Leycom Conductance Catheter"
912|NCT03001674|E2|Reported Event|Control Group|Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
913|NCT03001674|E1|Reported Event|IABP Recipient|"Prospective, double-arm, pilot study.
Conductance catheterization: CD Leycom Conductance Catheter"
914|NCT03001258|B4|Baseline|Total|Total of all reporting groups
941|NCT02997904|O4|Outcome|Number of Eggs Removed by Control|Total number of eggs removed after one hour of combing by control, analyzed separately
942|NCT02997904|O3|Outcome|Number of Eggs Removed by Resultz|Total number of eggs removed after one hour of combing, analyzed separately
915|NCT03001258|B3|Baseline|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.
In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.
Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
916|NCT03001258|B2|Baseline|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new cadre of community health workers of Brac. A two day presbyopia screening training were provided.
20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the camps.
The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity."
917|NCT03001258|B1|Baseline|PO (Program Organizers)|"PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity.
A total of 40 eye camps were held in two sub districts by eight POs."
918|NCT03001258|P3|Participant Flow|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.
In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.
Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
919|NCT03001258|P2|Participant Flow|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.
In this arm, 20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the total 40 eye camps.
Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as"
920|NCT03001258|P1|Participant Flow|PO (Program Organizers)|"PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided.
A total of eight POs organized eye camps in two sub districts. POs were responsible for identifying the presbyopia patients through screening and SS assisted in organizing and mobilizing the community people for the eye camps, and glass sale (on the spot). Four camps were organized per day for five days by four POs in each sub-district. A total of 40 eye camps were held in two sub districts by eight POs.
Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and managemen"
921|NCT03001258|O3|Outcome|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.
In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.
Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
943|NCT02997904|O2|Outcome|Number of Lice Removed by Control|Total number of lice removed after one hour of combing by control; analyzed separately
944|NCT02997904|O1|Outcome|Number or Lice Removed by Resultz|Total number of lice removed after one hour of combing with Resultz; analyzed separately
945|NCT02997904|O2|Outcome|Sham Lice and Egg Elimination Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
922|NCT03001258|O2|Outcome|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.
20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the eye camps.
The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
923|NCT03001258|O1|Outcome|PO (Program Organizers)|PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity. A total of 40 eye camps were held in two sub districts by eight POs.
924|NCT03001258|E3|Reported Event|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.
In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.
Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
925|NCT03001258|E2|Reported Event|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new cadre of community health workers of Brac. A two day presbyopia screening training were provided.
20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the eye camps.
The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
926|NCT03001258|E1|Reported Event|PO (Program Organizers)|PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity A total of 40 eye camps were held in two sub districts by eight POs.
927|NCT03000088|B3|Baseline|Total|Total of all reporting groups
928|NCT03000088|B2|Baseline|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet
intubate with 60° angled stylet"
929|NCT03000088|B1|Baseline|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet
intubate with 60° angled stylet"
930|NCT03000088|P2|Participant Flow|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet
intubate with 60° angled stylet"
931|NCT03000088|P1|Participant Flow|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet
intubate with 60° angled stylet"
932|NCT03000088|O2|Outcome|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet
intubate with 60° angled stylet"
933|NCT03000088|O1|Outcome|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet
intubate with 60° angled stylet"
934|NCT03000088|E2|Reported Event|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet
intubate with 60° angled stylet"
935|NCT03000088|E1|Reported Event|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet
intubate with 60° angled stylet"
936|NCT02997904|B3|Baseline|Total|Total of all reporting groups
937|NCT02997904|B2|Baseline|Sham Lice and Egg Removal Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
938|NCT02997904|B1|Baseline|Resultz Lice and Egg Removal Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
939|NCT02997904|P2|Participant Flow|Sham Lice and Egg Removal Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
940|NCT02997904|P1|Participant Flow|Resultz Lice and Egg Removal Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
2849|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
946|NCT02997904|O1|Outcome|Resultz Lice and Egg Elimination Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
947|NCT02997904|E2|Reported Event|Sham Lice and Egg Removal Kit|"20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
948|NCT02997904|E1|Reported Event|Resultz Lice and Egg Removal Kit|"Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb"
949|NCT02990910|B3|Baseline|Total|Total of all reporting groups
950|NCT02990910|B2|Baseline|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
conventional opioid analgesia: (b) all received 25μg/kg morphine"
951|NCT02990910|B1|Baseline|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
952|NCT02990910|P2|Participant Flow|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
conventional opioid analgesia: (b) all received 25μg/kg morphine"
953|NCT02990910|P1|Participant Flow|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
954|NCT02990910|O2|Outcome|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
conventional opioid analgesia: (b) all received 25μg/kg morphine"
955|NCT02990910|O1|Outcome|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
956|NCT02990910|O2|Outcome|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
conventional opioid analgesia: (b) all received 25μg/kg morphine"
957|NCT02990910|O1|Outcome|Personalized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
958|NCT02990910|E2|Reported Event|Conventional Opioid Analgesia|"Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
conventional opioid analgesia: (b) all received 25μg/kg morphine"
959|NCT02990910|E1|Reported Event|Individualized Opioid Analgesia|"One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine."
960|NCT02988219|B3|Baseline|Total|Total of all reporting groups
961|NCT02988219|B2|Baseline|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
962|NCT02988219|B1|Baseline|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
963|NCT02988219|P2|Participant Flow|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
964|NCT02988219|P1|Participant Flow|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
965|NCT02988219|O2|Outcome|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
966|NCT02988219|O1|Outcome|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
967|NCT02988219|O2|Outcome|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
968|NCT02988219|O1|Outcome|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
969|NCT02988219|E2|Reported Event|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
970|NCT02988219|E1|Reported Event|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
971|NCT02987374|B1|Baseline|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50
2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
972|NCT02987374|P1|Participant Flow|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50
2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
973|NCT02987374|O1|Outcome|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50
2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
974|NCT02987374|O1|Outcome|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50
2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
975|NCT02987374|E1|Reported Event|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50
2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
976|NCT02986282|B1|Baseline|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation
ABI measurement using both doppler and oscillometric method."
977|NCT02986282|P1|Participant Flow|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation
ABI measurement using both doppler and oscillometric method"
978|NCT02986282|O1|Outcome|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation
ABI measurement using both doppler and oscillometric method"
979|NCT02986282|O1|Outcome|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation
ABI measurement using both doppler and oscillometric method"
980|NCT02986282|E1|Reported Event|Single Arm|"Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation
ABI measurement using both doppler and oscillometric method"
981|NCT02977572|B3|Baseline|Total|Total of all reporting groups
982|NCT02977572|B2|Baseline|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
983|NCT02977572|B1|Baseline|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
984|NCT02977572|P2|Participant Flow|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
985|NCT02977572|P1|Participant Flow|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
986|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
987|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
988|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
1033|NCT02971670|B1|Baseline|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1061|NCT02964767|O1|Outcome|Prevalence of HIV/Tb. co Infection|Percentage of Tb. co infections among HIV patients enrolled at ART center.
8006|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
989|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
990|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
991|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
992|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
993|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
994|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
995|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
996|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
1034|NCT02971670|P4|Participant Flow|Dose Group 0|"Control: Al(OH)3 Adjuvant
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1062|NCT02964767|E2|Reported Event|HIV/Tb. co Infections|Patients with HIV-Tb. co infections
997|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
998|NCT02977572|O2|Outcome|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
999|NCT02977572|O1|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
1000|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
1001|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
1002|NCT02977572|O2|Outcome|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
1003|NCT02977572|O1|Outcome|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
1004|NCT02977572|E2|Reported Event|Continuous Positive Airway Pressure (CPAP) Group|"The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description"
1035|NCT02971670|P3|Participant Flow|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1063|NCT02964767|E1|Reported Event|HIV,|HIV patients
1064|NCT02961244|B3|Baseline|Total|Total of all reporting groups
1005|NCT02977572|E1|Reported Event|Non-Invasive Ventilation (NIV Group)|"For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8–10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%–94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description"
1006|NCT02974543|B3|Baseline|Total|Total of all reporting groups
1007|NCT02974543|B2|Baseline|Sham 1st (Auditory Only) Then Active (Bimodal)|To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.
1008|NCT02974543|B1|Baseline|Active 1st (Bimodal) Then Sham (Auditory Only)|During active treatment the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.
1009|NCT02974543|P2|Participant Flow|Active (Bimodal) Then Sham (Auditory Only)|"During active treatment, the device will deliver electric somatosensory and auditory stimulation.
To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.
Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.
Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.
The auditory stimulus will be individualized based on s"
1010|NCT02974543|P1|Participant Flow|Sham 1st (Auditory Only) Then Active (Bimodal)|"To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.
During active treatment, the device will deliver electric somatosensory and auditory stimulation.
Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.
Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.
The auditory stimulus will be individualized based on s"
1011|NCT02974543|O6|Outcome|Active After Sham|
1012|NCT02974543|O5|Outcome|Washout After Sham|
1013|NCT02974543|O4|Outcome|Sham Before Active|
1014|NCT02974543|O3|Outcome|Sham After Active|
1015|NCT02974543|O2|Outcome|Washout After Active|
1016|NCT02974543|O1|Outcome|Active Before Sham|
1017|NCT02974543|O6|Outcome|Active After Sham|
1018|NCT02974543|O5|Outcome|Washout After Sham|
1019|NCT02974543|O4|Outcome|Sham Before Active|
1020|NCT02974543|O3|Outcome|Sham After Active|
1021|NCT02974543|O2|Outcome|Washout After Active|
1022|NCT02974543|O1|Outcome|Active Before Sham|
1023|NCT02974543|E6|Reported Event|Active After Sham|
1024|NCT02974543|E5|Reported Event|Washout After Sham|
1025|NCT02974543|E4|Reported Event|Sham Before Active|
1026|NCT02974543|E3|Reported Event|Sham After Active|
1027|NCT02974543|E2|Reported Event|Washout After Active|
1028|NCT02974543|E1|Reported Event|Active Before Sham|
1029|NCT02971670|B5|Baseline|Total|Total of all reporting groups
1030|NCT02971670|B4|Baseline|Dose Group 0|"Control: Al(OH)3 Adjuvant
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1031|NCT02971670|B3|Baseline|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1032|NCT02971670|B2|Baseline|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1036|NCT02971670|P2|Participant Flow|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1037|NCT02971670|P1|Participant Flow|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1038|NCT02971670|O4|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1039|NCT02971670|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1040|NCT02971670|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1041|NCT02971670|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1042|NCT02971670|O4|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1043|NCT02971670|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1044|NCT02971670|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1045|NCT02971670|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1046|NCT02971670|O4|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1047|NCT02971670|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1048|NCT02971670|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1049|NCT02971670|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1050|NCT02971670|E4|Reported Event|Dose Group 0|"Control: Al(OH)3 Adjuvant
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1051|NCT02971670|E3|Reported Event|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1052|NCT02971670|E2|Reported Event|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1053|NCT02971670|E1|Reported Event|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg
rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
1054|NCT02964767|B3|Baseline|Total|Total of all reporting groups
1055|NCT02964767|B2|Baseline|2.HIV/Tb.|Patients with HIV/Tb. co infections
1065|NCT02961244|B2|Baseline|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket"
1066|NCT02961244|B1|Baseline|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
1067|NCT02961244|P2|Participant Flow|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket"
1068|NCT02961244|P1|Participant Flow|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
1069|NCT02961244|O2|Outcome|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket"
1070|NCT02961244|O1|Outcome|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
1071|NCT02961244|O2|Outcome|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket"
1072|NCT02961244|O1|Outcome|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
1073|NCT02961244|E2|Reported Event|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket"
1074|NCT02961244|E1|Reported Event|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
1075|NCT02959840|B4|Baseline|Total|Total of all reporting groups
1076|NCT02959840|B3|Baseline|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1077|NCT02959840|B2|Baseline|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1078|NCT02959840|B1|Baseline|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1079|NCT02959840|P3|Participant Flow|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1080|NCT02959840|P2|Participant Flow|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1081|NCT02959840|P1|Participant Flow|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1082|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1083|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1084|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1085|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1086|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1087|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1088|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1089|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1090|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1091|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1147|NCT02958956|E1|Reported Event|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
1148|NCT02958345|B3|Baseline|Total|Total of all reporting groups
1092|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1093|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1094|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1095|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1096|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1097|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1098|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1099|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1100|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1101|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1102|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1103|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1104|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1105|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1106|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1107|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1108|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1109|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1110|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1111|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1112|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1113|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1114|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1115|NCT02959840|O3|Outcome|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1116|NCT02959840|O2|Outcome|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1117|NCT02959840|O1|Outcome|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1118|NCT02959840|E3|Reported Event|Acupressure Point P6 Stimulator|Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
1119|NCT02959840|E2|Reported Event|Metoclopramide, Ondansetron|"10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia."
1120|NCT02959840|E1|Reported Event|Control|No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
1121|NCT02958995|B3|Baseline|Total|Total of all reporting groups
1122|NCT02958995|B2|Baseline|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
1123|NCT02958995|B1|Baseline|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
1124|NCT02958995|P2|Participant Flow|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
1125|NCT02958995|P1|Participant Flow|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
1126|NCT02958995|O2|Outcome|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
1127|NCT02958995|O1|Outcome|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
1128|NCT02958995|O2|Outcome|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
1129|NCT02958995|O1|Outcome|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
1130|NCT02958995|E2|Reported Event|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
1131|NCT02958995|E1|Reported Event|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
1132|NCT02958956|B3|Baseline|Total|Total of all reporting groups
1133|NCT02958956|B2|Baseline|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
1134|NCT02958956|B1|Baseline|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
1135|NCT02958956|P2|Participant Flow|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
1136|NCT02958956|P1|Participant Flow|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
1137|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
1138|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
1139|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
1140|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
1141|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
1142|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
1143|NCT02958956|O2|Outcome|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
1144|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
1145|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
1146|NCT02958956|E2|Reported Event|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
1300|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1149|NCT02958345|B2|Baseline|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.
Placebo: Injection of 0.65 mL of sterile normal saline"
1150|NCT02958345|B1|Baseline|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.
Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
1151|NCT02958345|P2|Participant Flow|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.
Placebo: Injection of 0.65 mL of sterile normal saline"
1152|NCT02958345|P1|Participant Flow|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.
Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
1153|NCT02958345|O2|Outcome|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.
Placebo: Injection of 0.65 mL of sterile normal saline"
1154|NCT02958345|O1|Outcome|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.
Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
1155|NCT02958345|O2|Outcome|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.
Placebo: Injection of 0.65 mL of sterile normal saline"
1156|NCT02958345|O1|Outcome|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.
Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
1157|NCT02958345|E2|Reported Event|Placebo|"Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm.
Placebo: Injection of 0.65 mL of sterile normal saline"
1158|NCT02958345|E1|Reported Event|Zostavax|"Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm.
Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert"
1159|NCT02951767|B1|Baseline|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1160|NCT02951767|P1|Participant Flow|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 milligrams (mg) via intravenous (IV) on Day 1 of 21-day cycles until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria or unmanageable toxicity.
1161|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1162|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1163|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1164|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1165|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1166|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1167|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1168|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1169|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1170|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1171|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1172|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1173|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1174|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1175|NCT02951767|E1|Reported Event|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
1176|NCT02949141|B1|Baseline|Ultrasound|"All patients will initially get an ultrasound (interpreted by emergency department physician) followed by chest x-ray (read by independent radiologist) and computed tomography (read by radiologist)
Lung Ultrasound: All patients will receive lung ultrasound, chest x-ray and computed tomography.
No adverse events were recorded."
1177|NCT02949141|P1|Participant Flow|All Participants|"All patients will initially get an ultrasound (interpreted by emergency department physician) followed by chest x-ray (read by independent radiologist) and computed tomography (read by radiologist)
Lung Ultrasound: All patients will receive lung ultrasound, chest x-ray and computed tomography."
1178|NCT02949141|O2|Outcome|Chest X-Ray|Chest x-ray diagnosis of pneumonia compared to CT
1179|NCT02949141|O1|Outcome|Ultrasound|Ultrasound Diagnosis of pneumonia compared to CT (Gold Standard)
1180|NCT02949141|E3|Reported Event|Chest Ct|Following US and CXR, all patients received a Chest CT as the gold standard for diagnosis of pneumonia.
1181|NCT02949141|E2|Reported Event|Chest X-ray|Chest x-ray for evaluation of pneumonia.
1182|NCT02949141|E1|Reported Event|Ultrasound|"Lung Ultrasound evaluation for pneumonia.
All patients will receive lung ultrasound, chest x-ray and computed tomography.
No adverse events were recorded."
1183|NCT02947984|B3|Baseline|Total|Total of all reporting groups
1184|NCT02947984|B2|Baseline|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.
Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
1185|NCT02947984|B1|Baseline|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Treatment based upon a treatment planning CT."
1186|NCT02947984|P2|Participant Flow|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.
Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
1187|NCT02947984|P1|Participant Flow|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Treatment based upon a treatment planning CT."
1188|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.
Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
1189|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Treatment based upon a treatment planning CT."
1190|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.
Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
1191|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Treatment based upon a treatment planning CT."
1192|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.
Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
1193|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Treatment based upon a treatment planning CT."
1194|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.
Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
1195|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Treatment based upon a treatment planning CT."
1196|NCT02947984|E2|Reported Event|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.
Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
1197|NCT02947984|E1|Reported Event|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.
Treatment based upon a treatment planning CT."
1198|NCT02941640|B5|Baseline|Total|Total of all reporting groups
1199|NCT02941640|B4|Baseline|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.
Laparoscopic appendectomy: The securing the base of appendix by DS clip.
DS clip"
1200|NCT02941640|B3|Baseline|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.
Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.
Hem-o-lok clip"
2850|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
1201|NCT02941640|B2|Baseline|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.
Laparoscopic appendectomy: The securing the base of appendix by Stapler.
Stapler"
1202|NCT02941640|B1|Baseline|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.
Laparoscopic appendectomy: The securing the base of appendix by endoloop.
Endoloop"
1203|NCT02941640|P4|Participant Flow|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.
Laparoscopic appendectomy: The securing the base of appendix by DS clip.
DS clip"
1204|NCT02941640|P3|Participant Flow|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.
Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.
Hem-o-lok clip"
1205|NCT02941640|P2|Participant Flow|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.
Laparoscopic appendectomy: The securing the base of appendix by Stapler.
Stapler"
1206|NCT02941640|P1|Participant Flow|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.
Laparoscopic appendectomy: The securing the base of appendix by endoloop.
Endoloop"
1207|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.
Laparoscopic appendectomy: The securing the base of appendix by DS clip.
DS clip"
1208|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.
Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.
Hem-o-lok clip"
1209|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.
Laparoscopic appendectomy: The securing the base of appendix by Stapler.
Stapler"
1210|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.
Laparoscopic appendectomy: The securing the base of appendix by endoloop.
Endoloop"
1211|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.
Laparoscopic appendectomy: The securing the base of appendix by DS clip.
DS clip"
1212|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.
Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.
Hem-o-lok clip"
1213|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.
Laparoscopic appendectomy: The securing the base of appendix by Stapler.
Stapler"
1214|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.
Laparoscopic appendectomy: The securing the base of appendix by endoloop.
Endoloop"
1215|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.
Laparoscopic appendectomy: The securing the base of appendix by DS clip.
DS clip"
1216|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.
Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.
Hem-o-lok clip"
1217|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.
Laparoscopic appendectomy: The securing the base of appendix by Stapler.
Stapler"
1218|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.
Laparoscopic appendectomy: The securing the base of appendix by endoloop.
Endoloop"
1219|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.
Laparoscopic appendectomy: The securing the base of appendix by DS clip.
DS clip"
1220|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.
Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.
Hem-o-lok clip"
1221|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.
Laparoscopic appendectomy: The securing the base of appendix by Stapler.
Stapler"
1222|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.
Laparoscopic appendectomy: The securing the base of appendix by endoloop.
Endoloop"
1223|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.
Laparoscopic appendectomy: The securing the base of appendix by DS clip.
DS clip"
1224|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.
Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.
Hem-o-lok clip"
1225|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.
Laparoscopic appendectomy: The securing the base of appendix by Stapler.
Stapler"
1226|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.
Laparoscopic appendectomy: The securing the base of appendix by endoloop.
Endoloop"
1227|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.
Laparoscopic appendectomy: The securing the base of appendix by DS clip.
DS clip"
1228|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.
Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.
Hem-o-lok clip"
1229|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.
Laparoscopic appendectomy: The securing the base of appendix by Stapler.
Stapler"
1230|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.
Laparoscopic appendectomy: The securing the base of appendix by endoloop.
Endoloop"
1231|NCT02941640|E4|Reported Event|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.
Laparoscopic appendectomy: The securing the base of appendix by DS clip.
DS clip"
1232|NCT02941640|E3|Reported Event|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.
Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.
Hem-o-lok clip"
1233|NCT02941640|E2|Reported Event|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.
Laparoscopic appendectomy: The securing the base of appendix by Stapler.
Stapler"
1234|NCT02941640|E1|Reported Event|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.
Laparoscopic appendectomy: The securing the base of appendix by endoloop.
Endoloop"
1235|NCT02934347|B3|Baseline|Total|Total of all reporting groups
1236|NCT02934347|B2|Baseline|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
1237|NCT02934347|B1|Baseline|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
1238|NCT02934347|P2|Participant Flow|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
1239|NCT02934347|P1|Participant Flow|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
1240|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
1241|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
1242|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
1243|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
1244|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
1245|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
1246|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
1247|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
1248|NCT02934347|E2|Reported Event|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
1249|NCT02934347|E1|Reported Event|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
1250|NCT02920749|B5|Baseline|Total|Total of all reporting groups
1251|NCT02920749|B4|Baseline|Group D|Anaesthesia was maintained with propofol and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
1252|NCT02920749|B3|Baseline|Group C|General anaesthesia was maintained with propofol.
1253|NCT02920749|B2|Baseline|Group B|Anaesthesia was maintained with sevoflurane and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
1254|NCT02920749|B1|Baseline|Group A|General anaesthesia was maintained with sevoflurane.
1255|NCT02920749|P4|Participant Flow|Group D|In this group anaesthesia was maintained with propofol. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Propofol and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
1256|NCT02920749|P3|Participant Flow|Group C|Anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol and fentanyl dosing was adjusted for the same MAP range. Atracurium was administered at regular intervals.
1257|NCT02920749|P2|Participant Flow|Group B|In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Sevoflurane and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
1258|NCT02920749|P1|Participant Flow|Group A|Anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane and fentanyl dosing was adjusted for the same MAP range for controlled hypotension within 60-85 mmHg. Atracurium was administered at regular intervals.
1259|NCT02920749|O4|Outcome|Group D|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol, fentanyl and atracurium.
Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used."
1260|NCT02920749|O3|Outcome|Group C|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol 1%, fentanyl and atracurium.
Cost was calculated in euros/1 hour. Disposable cost was calculated in euros."
1261|NCT02920749|O2|Outcome|Group B|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium.
Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used."
2851|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
1262|NCT02920749|O1|Outcome|Group A|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium.
Cost was calculated in euros/1 hour. Disposable cost was calculated in euros."
1263|NCT02920749|O4|Outcome|Group D|Fentanyl consumption was studied during total intravenous anaesthesia with BIS and TOF monitoring. It was registered in milligram.
1264|NCT02920749|O3|Outcome|Group C|Fentanyl consumption was studied during total intravenous anaesthesia. It was registered in milligram.
1265|NCT02920749|O2|Outcome|Group B|Fentanyl consumption was studied during sevoflurane anaesthesia with BIS and TOF monitoring. It was registered in milligram.
1266|NCT02920749|O1|Outcome|Group A|Fentanyl consumption was studied during sevoflurane anaesthesia. It was registered in milligram.
1267|NCT02920749|E4|Reported Event|Group D|During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
1268|NCT02920749|E3|Reported Event|Group C|During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
1269|NCT02920749|E2|Reported Event|Group B|"Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.
Fentanyl consumption was studied during anaesthesia. It was registered in milligram."
1270|NCT02920749|E1|Reported Event|Group A|"Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.
Fentanyl consumption was studied during anaesthesia. It was registered in milligram."
1271|NCT02919657|B1|Baseline|All Participants|All participants were given a baseline blood analysis
1272|NCT02919657|P2|Participant Flow|Whey Protein Isolate Then Genepro Gen2 Protein|"30g Serving of Whey Isolate Protein will be used daily in each subject.
1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject."
1273|NCT02919657|P1|Participant Flow|Genepro Gen2 Protein Then Whey Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.
30g Serving of Whey Isolate Protein will be used daily in each subject."
1274|NCT02919657|O2|Outcome|Whey Protein Isolate|"30g Serving of Whey Isolate Protein will be used daily in each subject.
Intervention: Weekly blood draws will determine the effect on blood protein levels.
Whey Protein: weekly blood draws to measure blood protein levels"
1275|NCT02919657|O1|Outcome|Genepro Gen2 Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.
Intervention: Weekly blood draws will determine the effect on blood protein levels.
Genepro Protein: weekly blood draws to measure blood protein levels"
1276|NCT02919657|E2|Reported Event|Whey Protein Isolate|"30g Serving of Whey Isolate Protein will be used daily in each subject.
Intervention: Weekly blood draws will determine the effect on blood protein levels.
Whey Protein: weekly blood draws to measure blood protein levels"
1277|NCT02919657|E1|Reported Event|Genepro Gen2 Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.
Intervention: Weekly blood draws will determine the effect on blood protein levels.
Genepro Protein: weekly blood draws to measure blood protein levels"
1278|NCT02912650|B5|Baseline|Total|Total of all reporting groups
1279|NCT02912650|B4|Baseline|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1280|NCT02912650|B3|Baseline|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1281|NCT02912650|B2|Baseline|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1282|NCT02912650|B1|Baseline|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1283|NCT02912650|P4|Participant Flow|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1284|NCT02912650|P3|Participant Flow|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1285|NCT02912650|P2|Participant Flow|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1286|NCT02912650|P1|Participant Flow|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1287|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1288|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1289|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1290|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1291|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1292|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1293|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1294|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1295|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1296|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1297|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1298|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1299|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1301|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1302|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1303|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1304|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1305|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1306|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1307|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1308|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1309|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1310|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1311|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1312|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1313|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1314|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1315|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1316|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1317|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1318|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1319|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1320|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1321|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1322|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1323|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1324|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1325|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1326|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1327|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1328|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1329|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1330|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1331|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1332|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1333|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1334|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1335|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1336|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1337|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1338|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1339|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1340|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1341|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1342|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1343|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1344|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1345|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1346|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1347|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1348|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1349|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1350|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1351|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1352|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1353|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1354|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1355|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1356|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1357|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1358|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1359|NCT02912650|O4|Outcome|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1360|NCT02912650|O3|Outcome|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1361|NCT02912650|O2|Outcome|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1362|NCT02912650|O1|Outcome|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1363|NCT02912650|E4|Reported Event|Acetaminophen 650 mg|Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
1364|NCT02912650|E3|Reported Event|Ibuprofen 250 mg|Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
1365|NCT02912650|E2|Reported Event|Ibuprofen 250 mg + Acetaminophen 500 mg|Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
1366|NCT02912650|E1|Reported Event|Placebo|Participants received Placebo as a single oral dose caplet during the study of 12 hours.
1367|NCT02910362|B3|Baseline|Total|Total of all reporting groups
1368|NCT02910362|B2|Baseline|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment
AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
1369|NCT02910362|B1|Baseline|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment
Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
1370|NCT02910362|P2|Participant Flow|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment
AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
1371|NCT02910362|P1|Participant Flow|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment
Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
1372|NCT02910362|O2|Outcome|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment
AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
1373|NCT02910362|O1|Outcome|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment
Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
1374|NCT02910362|E2|Reported Event|AMO Phacoemulsification Equipment|"cataract surgery with the AMO phacoemulsification equipment
AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment."
1375|NCT02910362|E1|Reported Event|Alcon Phacoemulsification Equipment|"cataract surgery performed with the Alcon phacoemulsification equipment
Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment."
1376|NCT02903238|B1|Baseline|Placebo|"placebo capsule
placebo: lactose containing capsule"
1377|NCT02903238|P1|Participant Flow|Placebo|"placebo capsule
placebo: lactose containing capsule"
1378|NCT02903238|O2|Outcome|Placebo Non-responders|"placebo capsule
placebo: lactose containing capsule"
1379|NCT02903238|O1|Outcome|Placebo Responders|"placebo capsule
placebo: lactose containing capsule"
1380|NCT02903238|O2|Outcome|Placebo Non-responders|"placebo capsule
placebo: lactose containing capsule"
1381|NCT02903238|O1|Outcome|Placebo Responders|"placebo capsule
placebo: lactose containing capsule"
1382|NCT02903238|O2|Outcome|Placebo Non-responders|"placebo capsule
placebo: lactose containing capsule"
1383|NCT02903238|O1|Outcome|Placebo Responders|"placebo capsule
placebo: lactose containing capsule"
1384|NCT02903238|E1|Reported Event|Placebo|"placebo capsule
placebo: lactose containing capsule"
1385|NCT02895347|B3|Baseline|Total|Total of all reporting groups
1386|NCT02895347|B2|Baseline|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
1387|NCT02895347|B1|Baseline|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
1388|NCT02895347|P2|Participant Flow|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
1389|NCT02895347|P1|Participant Flow|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
1390|NCT02895347|O1|Outcome|Experimental Group|"Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then they were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until they reached proficiency (91%) in all 4 activities. 4. Participants were asked to return where they were filmed and timed completing a suturing activity on the porcine model.
Surgical Simulation Practice Modules: The surgical simulation practice modules simulate surgical settings for suturing."
1391|NCT02895347|O2|Outcome|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
1392|NCT02895347|O1|Outcome|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
1393|NCT02895347|O2|Outcome|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
1394|NCT02895347|O1|Outcome|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
1395|NCT02895347|E2|Reported Event|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
1396|NCT02895347|E1|Reported Event|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
1397|NCT02891863|B1|Baseline|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.
LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
1398|NCT02891863|P1|Participant Flow|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.
LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
1399|NCT02891863|O1|Outcome|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.
LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
1400|NCT02891863|O1|Outcome|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.
LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
1401|NCT02891863|E1|Reported Event|Acute Testing|"Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.
LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods."
2852|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
1402|NCT02889289|B1|Baseline|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
1403|NCT02889289|P1|Participant Flow|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
1404|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
1405|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
1406|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
1407|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
1408|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
1409|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
1410|NCT02889289|E1|Reported Event|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
1428|NCT02884427|O3|Outcome|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.
Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
8007|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
1411|NCT02886338|B1|Baseline|Healthy Subjects With Capsule Endoscopy Device|"The movement of the endoscopic capsule in the esophagus could be driven by an external magnetic control device. The external magnetic control device could also adjust the direction of movement of the capsule in the stomach and duodenum, which might make the examination of the whole upper gastrointestinal tract possible.
capsule endoscopy: The magnetic navigated CE would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract."
1412|NCT02886338|P1|Participant Flow|Healthy Subjects With Capsule Endoscopy Device|"The movement of the endoscopic capsule in the esophagus could be driven by an external magnetic control device. The external magnetic control device could also adjust the direction of movement of the capsule in the stomach and duodenum, which might make the examination of the whole upper gastrointestinal tract possible.
capsule endoscopy: The magnetic navigated CE would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract."
1413|NCT02886338|O1|Outcome|Healthy Subjects With Capsule Endoscopy Device|All participants received the capsule endoscopic examination for the esopahgus, stomach and duodenum
1414|NCT02886338|E1|Reported Event|Healthy Subjects With Capsule Endoscopy Examination|"We included participants who were aged from 20 to 65 years. Exclude from the study were those (A) who had obstruction of the GI tract; (B) were pregnant; (C) had pacemaker implantation; (D) were implanted with metal or electronic devices, artificial joints or fixators (E) had cancer; (F) had difficulty in swallowing; (G) had a history of stomach operation.
All participants received the capsule endoscopic examination for the esophagus, stomach and duodenum."
1415|NCT02884427|B4|Baseline|Total|Total of all reporting groups
1416|NCT02884427|B3|Baseline|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.
Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
1417|NCT02884427|B2|Baseline|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.
Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
1418|NCT02884427|B1|Baseline|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.
Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
1419|NCT02884427|P3|Participant Flow|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.
Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
1420|NCT02884427|P2|Participant Flow|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.
Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
1421|NCT02884427|P1|Participant Flow|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.
Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
1422|NCT02884427|O3|Outcome|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.
Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
1423|NCT02884427|O2|Outcome|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.
Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
1424|NCT02884427|O1|Outcome|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.
Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
1425|NCT02884427|O3|Outcome|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.
Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
1426|NCT02884427|O2|Outcome|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.
Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
1427|NCT02884427|O1|Outcome|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.
Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
1429|NCT02884427|O2|Outcome|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.
Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
1430|NCT02884427|O1|Outcome|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.
Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
1431|NCT02884427|E3|Reported Event|Control|"Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.
Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working."
1432|NCT02884427|E2|Reported Event|Anode Stimulation|"Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.
Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current."
1433|NCT02884427|E1|Reported Event|Cathode Stimulation|"Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.
Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current."
1434|NCT02882152|B3|Baseline|Total|Total of all reporting groups
1435|NCT02882152|B2|Baseline|Morphine|"intrathecal morphine
morphine: Intrathecal morphine injection"
1436|NCT02882152|B1|Baseline|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve
femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
1437|NCT02882152|P2|Participant Flow|Morphine|"intrathecal morphine
morphine: Intrathecal morphine injection"
1438|NCT02882152|P1|Participant Flow|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve
femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
1439|NCT02882152|O2|Outcome|Morphine|"intrathecal morphine
morphine: Intrathecal morphine injection"
1440|NCT02882152|O1|Outcome|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve
femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
1441|NCT02882152|O2|Outcome|Morphine|"intrathecal morphine
morphine: Intrathecal morphine injection"
1442|NCT02882152|O1|Outcome|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve
femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
1443|NCT02882152|E2|Reported Event|Morphine|"intrathecal morphine
morphine: Intrathecal morphine injection"
1444|NCT02882152|E1|Reported Event|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve
femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
1445|NCT02873429|B3|Baseline|Total|Total of all reporting groups
1446|NCT02873429|B2|Baseline|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
1447|NCT02873429|B1|Baseline|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
1448|NCT02873429|P2|Participant Flow|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
1449|NCT02873429|P1|Participant Flow|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
1450|NCT02873429|O2|Outcome|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
1451|NCT02873429|O1|Outcome|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
1452|NCT02873429|O2|Outcome|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
1453|NCT02873429|O1|Outcome|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
1454|NCT02873429|O2|Outcome|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
1455|NCT02873429|O1|Outcome|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
1456|NCT02873429|E2|Reported Event|Conventional Medicine Group|Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.
1457|NCT02873429|E1|Reported Event|Integrative Medicine Group|Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
1458|NCT02867150|B1|Baseline|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional
Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system
UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
1459|NCT02867150|P1|Participant Flow|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional
Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system
UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
1460|NCT02867150|O1|Outcome|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional
Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system
UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
1461|NCT02867150|E1|Reported Event|Active Device|"Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional
Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system
UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
1462|NCT02863198|B3|Baseline|Total|Total of all reporting groups
1463|NCT02863198|B2|Baseline|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
1464|NCT02863198|B1|Baseline|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).
endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
1465|NCT02863198|P2|Participant Flow|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
1466|NCT02863198|P1|Participant Flow|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).
endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
1467|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
1468|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).
endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
1469|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
1470|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).
endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
1471|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
1472|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).
endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
1473|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
1474|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).
endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
1475|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
1476|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).
endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
1477|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
1510|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1478|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).
endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
1479|NCT02863198|E2|Reported Event|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
1480|NCT02863198|E1|Reported Event|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).
endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
1481|NCT02862600|B1|Baseline|Perhexiline|"Perhexiline will be administered orally. Dosing will be determined based on plasma level monitoring. For the first 8 week period, the target range will be 100-300 ng/mL, for the second 8 week period, the target range will be 300-500 ng/mL.
Perhexiline: Period 1 (Weeks 1-8) and Period 2 (Weeks 9-16): dose titrated to two different plasma levels of perhexiline
Use of bioanalytical assay to monitor plasma levels of perhexiline: The bioanalytical assay is the device under investigation. It will be used to monitor plasma levels of perhexiline. The data obtained from this analysis will be used to guide dose adjustments of perhexiline."
1482|NCT02862600|P1|Participant Flow|Perhexiline|Perhexiline: Period 1 (Weeks 1-8) and Period 2 (Weeks 9-16): dose titrated to two different plasma levels of perhexiline
1483|NCT02862600|O1|Outcome|Perhexiline--8 Weeks|Subjects completing 8 weeks of perhexiline at target range 100-300 ng/ml
1484|NCT02862600|O1|Outcome|Perhexiline--16 Weeks|Subjects completing 8 weeks of perhexiline at target range 100-300 ng/ml, and an additional 8 weeks of perhexiline at target range 300-500 ng/ml.
1485|NCT02862600|O1|Outcome|Perhexiline--8 Weeks|Subjects completing 8 weeks of perhexiline at target range 100-300 ng/ml.
1486|NCT02862600|O1|Outcome|Perhexiline--16 Weeks|Subjects completing 8 weeks of perhexiline at target range 100-300 ng/ml, and an additional 8 weeks of perhexiline at target range 300-500 ng/ml.
1487|NCT02862600|E1|Reported Event|Perhexiline|All enrolled subjects
1488|NCT02862106|B7|Baseline|Total|Total of all reporting groups
1489|NCT02862106|B6|Baseline|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1490|NCT02862106|B5|Baseline|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1491|NCT02862106|B4|Baseline|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1492|NCT02862106|B3|Baseline|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1493|NCT02862106|B2|Baseline|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1494|NCT02862106|B1|Baseline|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
1495|NCT02862106|P2|Participant Flow|Follow-up Group|Do not give any intervention, follow-up observation only
1496|NCT02862106|P1|Participant Flow|εPA-44 900μg|"Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
εPA-44: Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128"
1497|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1498|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1499|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1500|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1501|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1502|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
1503|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1504|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1505|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1506|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1507|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1508|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
1509|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1511|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1512|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1513|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1514|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
1515|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1516|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1517|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1518|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1519|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1520|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
1521|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1522|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1523|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1524|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1525|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1526|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
1527|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1528|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from theεPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1529|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1530|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1531|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1532|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
1533|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1534|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1535|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1536|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1537|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1538|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
1539|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1540|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1541|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1542|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1543|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1544|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
1545|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1546|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
2853|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
1547|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
1548|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1549|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
1550|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
1551|NCT02862106|E2|Reported Event|εPA-44 900μg Group|Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 All safety analyzes were analyzed in a safe population, and since 5 subjects had no safety data, they were excluded from the safety population
1552|NCT02862106|E1|Reported Event|Follow-up Group|Do not give any intervention, follow-up observation only All safety analyzes were analyzed in a safe population, and since 1 subjects had no safety data, they were excluded from the safety population
1553|NCT02856880|B1|Baseline|All Randomized Participants|All randomized participants were included for baseline evaluation.
1554|NCT02856880|P1|Participant Flow|Overall Study|This was a single-centre, analyst and examiner (plaque sample collector)-blind, randomized, five-treatment, five-period, cross-over study in healthy adult participants. Each participant received each of the five interventions i.e., Test Zinc-isopropylmethylphenol (IPMP), Test Zinc non-IPMP, Positive control, non-sodium lauryl sulphate (SLS) negative control, SLS negative control.
1555|NCT02856880|O5|Outcome|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
1556|NCT02856880|O4|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
1557|NCT02856880|O3|Outcome|Positive Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
1558|NCT02856880|O2|Outcome|Test Zinc Non- IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
1559|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
1560|NCT02856880|O5|Outcome|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150ppm fluoride as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
1561|NCT02856880|O4|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
1562|NCT02856880|O3|Outcome|Positive Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100ppm F as stannous fluoride) in 10mL water for 60 sec followed by rinse with 10mL water
1563|NCT02856880|O2|Outcome|Test Zinc Non- IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
1564|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
1565|NCT02856880|O5|Outcome|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150ppm fluoride as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
1566|NCT02856880|O4|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
1567|NCT02856880|O3|Outcome|Positive Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100ppm F as stannous fluoride) in 10mL water for 60 sec followed by rinse with 10mL water
1568|NCT02856880|O2|Outcome|Test Zinc Non- IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
1569|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
1570|NCT02856880|O2|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
1571|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
1572|NCT02856880|E5|Reported Event|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
1573|NCT02856880|E4|Reported Event|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
1574|NCT02856880|E3|Reported Event|Positive Control Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
2854|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
1575|NCT02856880|E2|Reported Event|Test Zinc Non- IPMP Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
1576|NCT02856880|E1|Reported Event|Test Zinc-IPMP Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
1577|NCT02850159|B3|Baseline|Total|Total of all reporting groups
1578|NCT02850159|B2|Baseline|rTMS Group|"high-frequency rTMS and sham tDCS
rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
1579|NCT02850159|B1|Baseline|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously
rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
1580|NCT02850159|P2|Participant Flow|rTMS Group|"high-frequency rTMS and sham tDCS
rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
1581|NCT02850159|P1|Participant Flow|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously
rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
1582|NCT02850159|O2|Outcome|rTMS Group|"high-frequency rTMS and sham tDCS
rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
1583|NCT02850159|O1|Outcome|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously
rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
1584|NCT02850159|E2|Reported Event|rTMS Group|"high-frequency rTMS and sham tDCS
rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
1585|NCT02850159|E1|Reported Event|Dual-mode Group|"the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously
rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously"
1586|NCT02849678|B3|Baseline|Total|Total of all reporting groups
1587|NCT02849678|B2|Baseline|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.
Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.
Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
1588|NCT02849678|B1|Baseline|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.
At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.
Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.
At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
1589|NCT02849678|P2|Participant Flow|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.
Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.
Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
1615|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens"
1616|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens"
1617|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens"
2638|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
1590|NCT02849678|P1|Participant Flow|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.
At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.
Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.
At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
1591|NCT02849678|O2|Outcome|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.
Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.
Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
1592|NCT02849678|O1|Outcome|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.
At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.
Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.
At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
1593|NCT02849678|E2|Reported Event|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.
Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.
Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
1594|NCT02849678|E1|Reported Event|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.
At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.
Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.
At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
1595|NCT02847169|B1|Baseline|Overall Participants|"Participants are randomized to wear filcon IV1 or ocufilcon D toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens
ocufilcon D: toric contact lens"
1596|NCT02847169|P2|Participant Flow|Ocufilcon D Toric Lens, Then Filcon IV1 Toric Lens|"Participants are randomized to wear ocufilcon D toric lens, then filcon IV1 lens pair for 1 week each during the cross over study.
filcon IV1: toric contact lens
ocufilcon D: toric contact lens"
1597|NCT02847169|P1|Participant Flow|Filcon IV1 Toric Lens, Then Ocufilcon D Toric Lens|"Participants are randomized to wear filcon IV1 toric lens, then ocufilcon D toric lens pair for 1 week each during the cross over study.
filcon IV1: toric contact lens
ocufilcon D: toric contact lens"
1598|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|Data collected at 1 week for ocufilcon D toric lens.
1599|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|Data collected at 1 week for filcon IV1 toric lens.
1600|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|Data collected at baseline for ocufilcon D toric lens.
1601|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|Data collected at baseline for filcon IV1 toric lens.
1602|NCT02847169|O1|Outcome|Habitual Toric Lens|Habitual data was gathered at baseline.
1603|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|Data collected at 1 week for ocufilcon D toric lens.
1604|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|Data collected at 1 week for filcon IV1 toric lens.
1605|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|Data collected at baseline for ocufilcon D toric lens.
1606|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|Data collected at baseline for filcon IV1 toric lens.
1607|NCT02847169|O1|Outcome|Habitual Toric Lens|Habitual data was gathered at baseline.
1608|NCT02847169|O2|Outcome|Ocufilcon D Toric Lens|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens"
1609|NCT02847169|O1|Outcome|Filcon IV1 Toric Lens|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens"
1610|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|Data collected at 1 week for ocufilcon D toric lens.
1611|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|Data collected at 1 week for filcon IV1 toric lens.
1612|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|Data collected at baseline for ocufilcon D toric lens.
1613|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|Data collected at baseline for filcon IV1 toric lens.
1614|NCT02847169|O1|Outcome|Habitual Toric Lens|Habitual data was assessed at baseline.
1618|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens"
1619|NCT02847169|O1|Outcome|Habitual Lens (Baseline)|Habitual lens assessed at baseline.
1620|NCT02847169|O3|Outcome|Substantially Decentered|Lens centration
1621|NCT02847169|O2|Outcome|Decentered Slightly|Lens centration
1622|NCT02847169|O1|Outcome|Optimal Centration|Lens centration
1623|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens"
1624|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens"
1625|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D: toric contact lens"
1626|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1: toric contact lens"
1627|NCT02847169|O1|Outcome|Habitual Lens (Baseline)|Habitual data was assessed at baseline.
1628|NCT02847169|E2|Reported Event|Ocufilcon D Toric Lens|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
ocufilcon D toric lens: toric contact lens"
1629|NCT02847169|E1|Reported Event|Filcon IV1 Toric Lens|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
filcon IV1 toric lens: toric contact lens"
1630|NCT02840916|B3|Baseline|Total|Total of all reporting groups
1631|NCT02840916|B2|Baseline|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)
sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
1632|NCT02840916|B1|Baseline|Verum Laser Acupuncture|"verum laser acupuncture
laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
1633|NCT02840916|P2|Participant Flow|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)
sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
1634|NCT02840916|P1|Participant Flow|Verum Laser Acupuncture|"verum laser acupuncture
laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
1635|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)
sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
1636|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture
laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
1637|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)
sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
1638|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture
laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
1639|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)
sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
1640|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture
laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
1641|NCT02840916|E2|Reported Event|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)
sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
1642|NCT02840916|E1|Reported Event|Verum Laser Acupuncture|"verum laser acupuncture
laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
1643|NCT02839772|B3|Baseline|Total|Total of all reporting groups
1644|NCT02839772|B2|Baseline|Current Skin Regimen Plus 2% Glycerine|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
1645|NCT02839772|B1|Baseline|Current Skin Care Regimen|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
1646|NCT02839772|P2|Participant Flow|Current Skin Regimen Plus 2% Glycerine|Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
1647|NCT02839772|P1|Participant Flow|Current Skin Care Regimen|Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
1648|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1649|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1650|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1651|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1652|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1653|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1654|NCT02839772|O1|Outcome|Correlation Between Number of Wounds and Days Lost Due to ADL|Correlation between nuumber of work days lost in previous month due to ADL and number of wounds (all skin breaches including areas of fungal infection)
1655|NCT02839772|O2|Outcome|Number of Days Lost by All Participants at 4th Visit|Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1656|NCT02839772|O1|Outcome|Number of Days Work Days Lost by All Participants Baseline|Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1657|NCT02839772|O2|Outcome|Number of Wounds 4th Visit|The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at 4th visit.
1658|NCT02839772|O1|Outcome|Number of Wounds at Baseline|The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at baseline.
1659|NCT02839772|O2|Outcome|Participants With Bad Odour From Legs/Feet at 4th Visit|Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.
1660|NCT02839772|O1|Outcome|Participants With Bad Odour From Legs/Feet at Baseline|Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.
1661|NCT02839772|O2|Outcome|Total Number of Trophic Skin Changes at 4th Visit|Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported. A reduction in the number of legs/feet with mossy changes would denote an improvement in the condition.
1662|NCT02839772|O1|Outcome|Total Number of Trophic Skin Changes at Baseline|Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported.
1663|NCT02839772|O2|Outcome|Stage of Podoconiosis 4th Visit|The number of legs with each stage of podoconiosis (1-5) and those with no disease
1664|NCT02839772|O1|Outcome|Stage of Podoconiosis 1st Visit|The number of legs with each stage of podoconiosis (1-5) and those with no disease
1665|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1666|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1667|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1668|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1669|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1753|NCT02826421|E2|Reported Event|UltraSert|All subjects treated with UltraSert
1754|NCT02826421|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
1670|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1671|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1672|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1673|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1674|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1675|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1676|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1677|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1678|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1679|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1680|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
1681|NCT02839772|E2|Reported Event|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
1682|NCT02839772|E1|Reported Event|Control Group|Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
1683|NCT02834624|B3|Baseline|Total|Total of all reporting groups
1684|NCT02834624|B2|Baseline|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
1685|NCT02834624|B1|Baseline|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
1686|NCT02834624|P2|Participant Flow|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
1687|NCT02834624|P1|Participant Flow|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
1688|NCT02834624|O2|Outcome|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
1689|NCT02834624|O1|Outcome|Poractant|Randomized to receive Poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
1690|NCT02834624|O2|Outcome|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
1691|NCT02834624|O1|Outcome|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
1692|NCT02834624|O2|Outcome|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
1693|NCT02834624|O1|Outcome|Poractant|Randomized to receive Poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
1694|NCT02834624|E2|Reported Event|Poractant Alfa|"Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
Poractant alfa: Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist."
1755|NCT02823080|B3|Baseline|Total|Total of all reporting groups
1695|NCT02834624|E1|Reported Event|Calfactant|"Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
calfactant: Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist"
1696|NCT02832375|B3|Baseline|Total|Total of all reporting groups
1697|NCT02832375|B2|Baseline|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1698|NCT02832375|B1|Baseline|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1699|NCT02832375|P2|Participant Flow|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1700|NCT02832375|P1|Participant Flow|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% weight by weight (w/w) of SnF (1100 parts per million [ppm] fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1701|NCT02832375|O2|Outcome|Standard: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1702|NCT02832375|O1|Outcome|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1703|NCT02832375|O2|Outcome|Standard: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1704|NCT02832375|O1|Outcome|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1705|NCT02832375|O2|Outcome|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1706|NCT02832375|O1|Outcome|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1707|NCT02832375|E2|Reported Event|Standard: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1708|NCT02832375|E1|Reported Event|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
1709|NCT02829775|B1|Baseline|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
1710|NCT02829775|P1|Participant Flow|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
1711|NCT02829775|O1|Outcome|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
1712|NCT02829775|O1|Outcome|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
2639|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
1713|NCT02829775|E1|Reported Event|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
1714|NCT02829463|B3|Baseline|Total|Total of all reporting groups
1715|NCT02829463|B2|Baseline|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.
Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
1716|NCT02829463|B1|Baseline|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.
Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
1717|NCT02829463|P2|Participant Flow|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.
Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
1718|NCT02829463|P1|Participant Flow|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.
Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
1719|NCT02829463|O2|Outcome|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.
Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
1720|NCT02829463|O1|Outcome|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.
Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
1721|NCT02829463|E2|Reported Event|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.
Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
1722|NCT02829463|E1|Reported Event|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.
Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
1723|NCT02828137|B4|Baseline|Total|Total of all reporting groups
1724|NCT02828137|B3|Baseline|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
1725|NCT02828137|B2|Baseline|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
1726|NCT02828137|B1|Baseline|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
1727|NCT02828137|P3|Participant Flow|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
1728|NCT02828137|P2|Participant Flow|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
1729|NCT02828137|P1|Participant Flow|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
1730|NCT02828137|O3|Outcome|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90 IMR 32.95 ± 20.60
1731|NCT02828137|O2|Outcome|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90 IMR 23.22 ± 12.73
1732|NCT02828137|O1|Outcome|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78 IMR 21.94 ± 12.87
1733|NCT02828137|E3|Reported Event|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
1734|NCT02828137|E2|Reported Event|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
1735|NCT02828137|E1|Reported Event|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
1736|NCT02826421|B5|Baseline|Total|Total of all reporting groups
1737|NCT02826421|B4|Baseline|Monarch III D|Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
1738|NCT02826421|B3|Baseline|iSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
1739|NCT02826421|B2|Baseline|iTec|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
1740|NCT02826421|B1|Baseline|UltraSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
1741|NCT02826421|P4|Participant Flow|Monarch III D|Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
1742|NCT02826421|P3|Participant Flow|iSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
1743|NCT02826421|P2|Participant Flow|iTec|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
1744|NCT02826421|P1|Participant Flow|UltraSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
1745|NCT02826421|O2|Outcome|Monarch III D|Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
1746|NCT02826421|O1|Outcome|UltraSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
1747|NCT02826421|O3|Outcome|iSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
1748|NCT02826421|O2|Outcome|iTec|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
1749|NCT02826421|O1|Outcome|UltraSert|Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
1750|NCT02826421|E5|Reported Event|Monarch III D|All subjects treated with Monarch III D
1751|NCT02826421|E4|Reported Event|iSert|All subjects treated with iSert
1752|NCT02826421|E3|Reported Event|iTec|All subjects treated with iTec
1756|NCT02823080|B2|Baseline|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1757|NCT02823080|B1|Baseline|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1758|NCT02823080|P2|Participant Flow|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1759|NCT02823080|P1|Participant Flow|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD(maximal ovarian diameter) were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1760|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1761|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1762|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1763|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1764|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1765|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1766|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1767|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1768|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1769|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1770|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1771|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1772|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1773|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1774|NCT02823080|E2|Reported Event|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1775|NCT02823080|E1|Reported Event|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
1823|NCT02818244|P1|Participant Flow|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1824|NCT02818244|O4|Outcome|Apple Watch|Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1776|NCT02822885|B1|Baseline|Ultrasonography|"Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
Ultrasonography: Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries"
1777|NCT02822885|P1|Participant Flow|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
1778|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
1779|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
1780|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
1781|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
1782|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
1783|NCT02822885|E1|Reported Event|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
1784|NCT02822287|B1|Baseline|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
1785|NCT02822287|P1|Participant Flow|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
1786|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
1787|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
1788|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
1789|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
1790|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
1791|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
1792|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
1793|NCT02822287|E1|Reported Event|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
1794|NCT02821403|B3|Baseline|Total|Total of all reporting groups
1795|NCT02821403|B2|Baseline|Middle-aged Adults|"adults with presbyopia who aged over 40 years
Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
1796|NCT02821403|B1|Baseline|Young Adults|"adults without presbyopia who aged 18-35 years
Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
1797|NCT02821403|P2|Participant Flow|Middle-aged Adults|"adults with presbyopia who aged over 40 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
Cross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1798|NCT02821403|P1|Participant Flow|Young Adults|"adults without presbyopia who aged 18-35 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
Cross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1799|NCT02821403|O2|Outcome|Middle-aged Adults|"adults with presbyopia who aged over 40 years
Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
1800|NCT02821403|O1|Outcome|Young Adults|"adults without presbyopia who aged 18-35 years
Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
1801|NCT02821403|O6|Outcome|Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin|"adults with presbyopia who aged over 40 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
2640|NCT02759692|E2|Reported Event|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
1802|NCT02821403|O5|Outcome|Middle-aged Adults: Regular Coating Lens With Yellow Tint|"adults with presbyopia who aged over 40 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1803|NCT02821403|O4|Outcome|Middle-aged Adults: Clear Lens With Regular Coating|"adults with presbyopia who aged over 40 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1804|NCT02821403|O3|Outcome|Young Adults: Clear Lens With Blue-light Blocking Coating|"adults without presbyopia who aged 18-35 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1805|NCT02821403|O2|Outcome|Young Adults: Regular Coating Lens With Yellow Tint|"adults without presbyopia who aged 18-35 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1806|NCT02821403|O1|Outcome|Young Adults: Clear Lens With Regular Coating|"adults without presbyopia who aged 18-35 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1807|NCT02821403|O6|Outcome|Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin|"adults with presbyopia who aged over 40 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1808|NCT02821403|O5|Outcome|Middle-aged Adults: Regular Coating Lens With Yellow Tint|"adults with presbyopia who aged over 40 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1809|NCT02821403|O4|Outcome|Middle-aged Adults: Clear Lens With Regular Coating|"adults with presbyopia who aged over 40 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1810|NCT02821403|O3|Outcome|Young Adults: Clear Lens With Blue-light Blocking Coating|"adults without presbyopia who aged 18-35 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1811|NCT02821403|O2|Outcome|Young Adults: Regular Coating Lens With Yellow Tint|"adults without presbyopia who aged 18-35 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1812|NCT02821403|O1|Outcome|Young Adults: Clear Lens With Regular Coating|"adults without presbyopia who aged 18-35 years
Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.
The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
1813|NCT02821403|E2|Reported Event|Middle-aged Adults|"adults with presbyopia who aged over 40 years
Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
1814|NCT02821403|E1|Reported Event|Young Adults|"adults without presbyopia who aged 18-35 years
Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
1815|NCT02818244|B5|Baseline|Total|Total of all reporting groups
1816|NCT02818244|B4|Baseline|Apple Watch|Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1817|NCT02818244|B3|Baseline|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1818|NCT02818244|B2|Baseline|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1819|NCT02818244|B1|Baseline|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1820|NCT02818244|P4|Participant Flow|Apple Watch|Apple Watch Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1821|NCT02818244|P3|Participant Flow|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1822|NCT02818244|P2|Participant Flow|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
8008|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
1825|NCT02818244|O3|Outcome|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1826|NCT02818244|O2|Outcome|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1827|NCT02818244|O1|Outcome|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1828|NCT02818244|E4|Reported Event|Apple Watch|Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1829|NCT02818244|E3|Reported Event|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1830|NCT02818244|E2|Reported Event|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1831|NCT02818244|E1|Reported Event|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
1832|NCT02817763|B3|Baseline|Total|Total of all reporting groups
1833|NCT02817763|B2|Baseline|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
1834|NCT02817763|B1|Baseline|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
1835|NCT02817763|P2|Participant Flow|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
1836|NCT02817763|P1|Participant Flow|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
1837|NCT02817763|O2|Outcome|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
1838|NCT02817763|O1|Outcome|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
1839|NCT02817763|O2|Outcome|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
1870|NCT02814227|B1|Baseline|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography
Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
8009|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
1840|NCT02817763|O1|Outcome|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
1841|NCT02817763|E2|Reported Event|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
1842|NCT02817763|E1|Reported Event|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
1843|NCT02815735|B1|Baseline|Overall Participants|"Participants wear comfilcon A and lotrafilcon B lens for 4 weeks during the cross over study.
comfilcon A: contact lens
lotrafilcon B: contact lens"
1844|NCT02815735|P2|Participant Flow|Lotrafilcon B, Then Comfilcon A|"Participants wear lotrafilcon B lens, then comfilcon A lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens
comfilcon A: contact lens"
1845|NCT02815735|P1|Participant Flow|Comfilcon A, Then Lotrafilcon B|"Participants wear comfilcon A lens, then lotrafilcon B for 4 weeks during the cross over study.
comfilcon A: contact lens
lotrafilcon B: contact lens"
1846|NCT02815735|O6|Outcome|Lotrafilcon B (Day 26)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens"
1847|NCT02815735|O5|Outcome|Comfilcon A (Day 26)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.
comfilcon A: contact lens"
1848|NCT02815735|O4|Outcome|Lotrafilcon B (Day 12)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens"
1849|NCT02815735|O3|Outcome|Comfilcon A (Day 12)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.
comfilcon A: contact lens"
1850|NCT02815735|O2|Outcome|Lotrafilcon B (Day 3)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens"
1851|NCT02815735|O1|Outcome|Comfilcon A (Day 3)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.
comfilcon A: contact lens"
1852|NCT02815735|O5|Outcome|Lotrafilcon B (4 Weeks)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens"
1853|NCT02815735|O4|Outcome|Comfilcon A (4 Weeks)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.
comfilcon A: contact lens"
1854|NCT02815735|O3|Outcome|Lotrafilcon B (2 Weeks)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens"
1855|NCT02815735|O2|Outcome|Comfilcon A (2 Weeks)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.
comfilcon A: contact lens"
1856|NCT02815735|O1|Outcome|Habitual (Baseline)|Habitual data assessed at baseline.
1857|NCT02815735|E2|Reported Event|Lotrafilcon B|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens"
1858|NCT02815735|E1|Reported Event|Comfilcon A|"Participants wear comfilcon A lens for 4 weeks during the cross over study.
comfilcon A: contact lens"
1859|NCT02814279|B3|Baseline|Total|Total of all reporting groups
1860|NCT02814279|B2|Baseline|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.
Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
1861|NCT02814279|B1|Baseline|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.
CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
1871|NCT02814227|P1|Participant Flow|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography
Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
2054|NCT02801396|P3|Participant Flow|Test2/Test1/Control|Subjects that received Test lens 2 during the first period, Test lens 1 during the second period and the Control lens during the third period.
1862|NCT02814279|P2|Participant Flow|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.
Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
1863|NCT02814279|P1|Participant Flow|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.
CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
1864|NCT02814279|O2|Outcome|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.
Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
1865|NCT02814279|O1|Outcome|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.
CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
1866|NCT02814279|O2|Outcome|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.
Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
1867|NCT02814279|O1|Outcome|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.
CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
1868|NCT02814279|E2|Reported Event|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.
Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
1869|NCT02814279|E1|Reported Event|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.
CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
2042|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route
Placebo"
8010|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
1872|NCT02814227|O1|Outcome|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography
Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
1873|NCT02814227|O1|Outcome|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography
Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
1874|NCT02814227|O1|Outcome|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography
Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
1875|NCT02814227|O1|Outcome|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography
Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
1876|NCT02814227|E1|Reported Event|Zansors® Sleep Screening Device|"Zansors device compared to overnight polysomnography
Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography"
1877|NCT02813070|B4|Baseline|Total|Total of all reporting groups
1878|NCT02813070|B3|Baseline|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1879|NCT02813070|B2|Baseline|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of aMCI, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1880|NCT02813070|B1|Baseline|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1881|NCT02813070|P3|Participant Flow|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1882|NCT02813070|P2|Participant Flow|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of amnestic mild cognitive impairment (aMCI), received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1883|NCT02813070|P1|Participant Flow|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of probable Alzheimer's disease (pAD), received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent Positron emission tomography (PET) imaging.
1884|NCT02813070|O2|Outcome|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1885|NCT02813070|O1|Outcome|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1886|NCT02813070|O2|Outcome|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1887|NCT02813070|O1|Outcome|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1888|NCT02813070|E3|Reported Event|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1889|NCT02813070|E2|Reported Event|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of aMCI, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1890|NCT02813070|E1|Reported Event|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
1891|NCT02809911|B3|Baseline|Total|Total of all reporting groups
1892|NCT02809911|B2|Baseline|Active Provant|"Active Provant Treatment
Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment."
1893|NCT02809911|B1|Baseline|Sham of Provant|"Sham of Provant Therapy System
Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment."
1894|NCT02809911|P2|Participant Flow|Active Provant|"Active Provant Treatment
Provant"
1895|NCT02809911|P1|Participant Flow|Sham of Provant|"Sham of Provant Therapy System
Provant"
1896|NCT02809911|O2|Outcome|Active Provant|"Active Provant Treatment
Provant"
1897|NCT02809911|O1|Outcome|Sham of Provant|"Sham of Provant Therapy System
Provant"
1898|NCT02809911|O2|Outcome|Active Provant|"Active Provant Treatment
Provant"
1899|NCT02809911|O1|Outcome|Sham of Provant|"Sham of Provant Therapy System
Provant"
1900|NCT02809911|E2|Reported Event|Active Provant|"Active Provant Treatment
Provant"
1901|NCT02809911|E1|Reported Event|Sham of Provant|"Sham of Provant Therapy System
Provant"
1902|NCT02809833|B1|Baseline|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
2043|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
Calcifediol"
8011|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
1903|NCT02809833|P1|Participant Flow|Tocilizumab for Rheumatoid Arthritis (RA) in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to the Summary of Product Characteristics (SmPC) were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion at 4-week intervals.
1904|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1905|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1906|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1907|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1908|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1909|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1910|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1911|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1912|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1913|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1914|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1915|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1916|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1917|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1918|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1919|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
2044|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route
Placebo"
2045|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
Calcifediol"
1920|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1921|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1922|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1923|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1924|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1925|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1926|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1927|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1928|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1929|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1930|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1931|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1932|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1933|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1934|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1935|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1936|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1937|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1938|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1939|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1940|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1941|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1942|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1943|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1944|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1945|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1946|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1947|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1948|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1949|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1950|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1951|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1952|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1953|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1954|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1955|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1956|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1957|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1958|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1959|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1960|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1961|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1962|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1963|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1964|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1965|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1966|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1967|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1968|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1969|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1970|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1971|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1972|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1973|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1974|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1975|NCT02809833|E1|Reported Event|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
1976|NCT02808130|B7|Baseline|Total|Total of all reporting groups
1977|NCT02808130|B6|Baseline|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1978|NCT02808130|B5|Baseline|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1979|NCT02808130|B4|Baseline|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1980|NCT02808130|B3|Baseline|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1981|NCT02808130|B2|Baseline|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1982|NCT02808130|B1|Baseline|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1983|NCT02808130|P6|Participant Flow|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2046|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route
Placebo"
2047|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
Calcifediol"
2048|NCT02805907|E2|Reported Event|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route
Placebo"
2049|NCT02805907|E1|Reported Event|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
Calcifediol"
1984|NCT02808130|P5|Participant Flow|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1985|NCT02808130|P4|Participant Flow|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1986|NCT02808130|P3|Participant Flow|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1987|NCT02808130|P2|Participant Flow|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1988|NCT02808130|P1|Participant Flow|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1989|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1990|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1991|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1992|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1993|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1994|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1995|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1996|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1997|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1998|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
1999|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2000|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2001|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2050|NCT02801396|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
2855|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
2002|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2003|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2004|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2005|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2006|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2007|NCT02808130|E6|Reported Event|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2008|NCT02808130|E5|Reported Event|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2009|NCT02808130|E4|Reported Event|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2051|NCT02801396|P6|Participant Flow|Control/Test2/Test1|Subjects that received the Control lens during the first period, Test 2 lens during the second period and Test lens 1 during the third period.
2052|NCT02801396|P5|Participant Flow|Control/Test1/Test2|Subjects that received the Control lens during the first period, Test lens 1 during the second period and Test lens 2 during the third period.
2053|NCT02801396|P4|Participant Flow|Test2/Control/Test1|Subjects that received Test lens 2 during the first period, the Control lens during the second and the Test 1 lens during the third period.
2010|NCT02808130|E3|Reported Event|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2011|NCT02808130|E2|Reported Event|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2012|NCT02808130|E1|Reported Event|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.
hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
2013|NCT02806544|B1|Baseline|Tamoxifen|"Tamoxifen 20mg by mouth daily
Tamoxifen: Tamoxifen 20mg by mouth daily"
2014|NCT02806544|P1|Participant Flow|Tamoxifen|"Tamoxifen 20mg by mouth daily
Tamoxifen: Tamoxifen 20mg by mouth daily"
2015|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily
Tamoxifen: Tamoxifen 20mg by mouth daily"
2016|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily
Tamoxifen: Tamoxifen 20mg by mouth daily"
2017|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily
Tamoxifen: Tamoxifen 20mg by mouth daily"
2018|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily
Tamoxifen: Tamoxifen 20mg by mouth daily"
2019|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily
Tamoxifen: Tamoxifen 20mg by mouth daily"
2020|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily
Tamoxifen: Tamoxifen 20mg by mouth daily"
2021|NCT02806544|E1|Reported Event|Tamoxifen|"Tamoxifen 20mg by mouth daily
Tamoxifen: Tamoxifen 20mg by mouth daily"
2022|NCT02806505|B3|Baseline|Total|Total of all reporting groups
2023|NCT02806505|B2|Baseline|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
2024|NCT02806505|B1|Baseline|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
2025|NCT02806505|P2|Participant Flow|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
2026|NCT02806505|P1|Participant Flow|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
2027|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
2028|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
2029|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
2030|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
2031|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
2032|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
2033|NCT02806505|E2|Reported Event|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
2034|NCT02806505|E1|Reported Event|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
2035|NCT02805907|B3|Baseline|Total|Total of all reporting groups
2036|NCT02805907|B2|Baseline|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route
Placebo"
2037|NCT02805907|B1|Baseline|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
Calcifediol"
2038|NCT02805907|P2|Participant Flow|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route
Placebo"
2039|NCT02805907|P1|Participant Flow|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
Calcifediol"
2040|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route
Placebo"
2041|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
Calcifediol"
2055|NCT02801396|P2|Participant Flow|Test1/Control/Test2|Subjects that received Test lens 1 during the first period, the Control lens during the second period and Test lens 2 during the third period.
2056|NCT02801396|P1|Participant Flow|Test1/Test2/Control|Subjects that received Test lens 1 during the first period, Test lens 2 during the second period and the Control lens during the third period.
2057|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
2058|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
2059|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
2060|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
2061|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
2062|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
2063|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
2064|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
2065|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
2066|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
2067|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
2068|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
2069|NCT02801396|E3|Reported Event|Control|Subjects that wore the control lens during any of the 3 study periods.
2070|NCT02801396|E2|Reported Event|Test2|Subjects that wore the Test 2 lens during any of the 3 periods.
2071|NCT02801396|E1|Reported Event|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
2072|NCT02799082|B3|Baseline|Total|Total of all reporting groups
2073|NCT02799082|B2|Baseline|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2074|NCT02799082|B1|Baseline|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2075|NCT02799082|P2|Participant Flow|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2076|NCT02799082|P1|Participant Flow|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2077|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2078|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2079|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2080|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2081|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2082|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2083|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2084|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2238|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
8012|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
2085|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2086|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2087|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2088|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2089|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2090|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2091|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2092|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2093|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2094|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2095|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2096|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2097|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2098|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2099|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2100|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2101|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2102|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2239|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
8013|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
2103|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2104|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2105|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2106|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2107|NCT02799082|E2|Reported Event|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2108|NCT02799082|E1|Reported Event|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
2109|NCT02799069|B4|Baseline|Total|Total of all reporting groups
2110|NCT02799069|B3|Baseline|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2111|NCT02799069|B2|Baseline|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2112|NCT02799069|B1|Baseline|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2113|NCT02799069|P3|Participant Flow|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2114|NCT02799069|P2|Participant Flow|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2115|NCT02799069|P1|Participant Flow|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2116|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2117|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2118|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2119|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2120|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2121|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2856|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
2122|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2123|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2124|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2125|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2126|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2127|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2128|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2129|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2130|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2131|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2132|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2133|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2134|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2135|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2136|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2137|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2138|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2139|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2240|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2140|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2141|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2142|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2143|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2144|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2145|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2146|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2147|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2148|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2149|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2150|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2151|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2152|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2153|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2154|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2155|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2156|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2157|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2241|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2158|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2159|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2160|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2161|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2162|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2163|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2164|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2165|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2166|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2167|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2168|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2169|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2170|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2171|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2172|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2173|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2174|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2175|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2242|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2176|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2177|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2178|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2179|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2180|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2181|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2182|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2183|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2184|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2185|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2186|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2187|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2188|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2189|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2190|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2191|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2192|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2193|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2243|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2194|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2195|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2196|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2197|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2198|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2199|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2200|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2201|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2202|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2203|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2204|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2205|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2206|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2207|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2208|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2209|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2210|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2211|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2244|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2212|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2213|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2214|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2215|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2216|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2217|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2218|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2219|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2220|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2221|NCT02799069|E3|Reported Event|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2222|NCT02799069|E2|Reported Event|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2223|NCT02799069|E1|Reported Event|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
2224|NCT02796092|B3|Baseline|Total|Total of all reporting groups
2225|NCT02796092|B2|Baseline|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2226|NCT02796092|B1|Baseline|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2227|NCT02796092|P2|Participant Flow|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2228|NCT02796092|P1|Participant Flow|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2229|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2230|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2231|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2232|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2233|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2234|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2235|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2236|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2237|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2245|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2246|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2247|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2248|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2249|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2250|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2251|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2252|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2253|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2254|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2255|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2256|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2257|NCT02796092|E2|Reported Event|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs"
2258|NCT02796092|E1|Reported Event|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils"
2259|NCT02792049|B3|Baseline|Total|Total of all reporting groups
2260|NCT02792049|B2|Baseline|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
2261|NCT02792049|B1|Baseline|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
2262|NCT02792049|P2|Participant Flow|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
2263|NCT02792049|P1|Participant Flow|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
2264|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
2265|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
2266|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
2267|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
2268|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
2269|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
2270|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
2296|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2271|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
2272|NCT02792049|O2|Outcome|Conventional Ambu Spur II Bag Valve Mask|A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
2273|NCT02792049|O1|Outcome|Modified Ambu Spur II Bag Valve Mask|A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
2274|NCT02792049|E2|Reported Event|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
2275|NCT02792049|E1|Reported Event|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
2276|NCT02791659|B3|Baseline|Total|Total of all reporting groups
2277|NCT02791659|B2|Baseline|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.
Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
2278|NCT02791659|B1|Baseline|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.
Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
2279|NCT02791659|P2|Participant Flow|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.
Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
2280|NCT02791659|P1|Participant Flow|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.
Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
2281|NCT02791659|O2|Outcome|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.
Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
2282|NCT02791659|O1|Outcome|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.
Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
2283|NCT02791659|E2|Reported Event|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.
Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
2284|NCT02791659|E1|Reported Event|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.
Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
2285|NCT02791269|B3|Baseline|Total|Total of all reporting groups
2286|NCT02791269|B2|Baseline|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2287|NCT02791269|B1|Baseline|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2288|NCT02791269|P2|Participant Flow|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2289|NCT02791269|P1|Participant Flow|HBeAg Negative Participants|Hepatitis B e antigen (HBeAg) negative participants received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2290|NCT02791269|O1|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2291|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2292|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2293|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2294|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2295|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2641|NCT02759692|E1|Reported Event|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
2297|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2298|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period
2299|NCT02791269|O1|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2300|NCT02791269|E2|Reported Event|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2301|NCT02791269|E1|Reported Event|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
2302|NCT02790281|B1|Baseline|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
2303|NCT02790281|P1|Participant Flow|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
2304|NCT02790281|O1|Outcome|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
2305|NCT02790281|O1|Outcome|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
2306|NCT02790281|O1|Outcome|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
2307|NCT02790281|E1|Reported Event|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
2308|NCT02788357|B3|Baseline|Total|Total of all reporting groups
2309|NCT02788357|B2|Baseline|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2310|NCT02788357|B1|Baseline|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2311|NCT02788357|P2|Participant Flow|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2312|NCT02788357|P1|Participant Flow|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2313|NCT02788357|O2|Outcome|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2314|NCT02788357|O1|Outcome|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2315|NCT02788357|O2|Outcome|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2316|NCT02788357|O1|Outcome|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2317|NCT02788357|O2|Outcome|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2318|NCT02788357|O1|Outcome|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2319|NCT02788357|O2|Outcome|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2320|NCT02788357|O1|Outcome|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2321|NCT02788357|E2|Reported Event|Placebo With Motor Training|"Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2322|NCT02788357|E1|Reported Event|Atomoxetine With Motor Training|"40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake."
2323|NCT02788097|B3|Baseline|Total|Total of all reporting groups
2324|NCT02788097|B2|Baseline|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation
Progesterone supplementation: artificial frozen embryo transfers"
2325|NCT02788097|B1|Baseline|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation
Progesterone supplementation: artificial frozen embryo transfers"
2326|NCT02788097|P2|Participant Flow|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation
Progesterone supplementation: artificial frozen embryo transfers
69 patients randomized to this group"
2327|NCT02788097|P1|Participant Flow|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation
Progesterone supplementation: artificial frozen embryo transfers
61 patients randomized to this group"
2328|NCT02788097|O2|Outcome|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation
Progesterone supplementation: artificial frozen embryo transfers
69 patients randomized to this group"
2329|NCT02788097|O1|Outcome|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation
Progesterone supplementation: artificial frozen embryo transfers
61 patients randomized to this group"
2330|NCT02788097|E2|Reported Event|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation
Progesterone supplementation: artificial frozen embryo transfers
69 patients randomized to this group"
2331|NCT02788097|E1|Reported Event|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation
Progesterone supplementation: artificial frozen embryo transfers
61 patients randomized to this group"
2332|NCT02786927|B1|Baseline|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
2333|NCT02786927|P1|Participant Flow|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
2334|NCT02786927|O1|Outcome|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
2335|NCT02786927|O1|Outcome|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
2336|NCT02786927|O1|Outcome|ELLIPTA and HandiHaler|Participants were randomized to receive placebo using ELLIPTA inhaler and HandiHaler inhaler once daily for 5-9 days each in a crossover manner along with their routine COPD medication.
2337|NCT02786927|E2|Reported Event|HandiHaler|Participants received HandiHaler inhaler at Visit 1/ Visit 2 once daily for 5-9 days.
2338|NCT02786927|E1|Reported Event|ELLIPTA|Participants received ELLIPTA inhaler at Visit 1/Visit 2 once daily for 5-9 days.
2339|NCT02786004|B3|Baseline|Total|Total of all reporting groups
2340|NCT02786004|B2|Baseline|Digital Breast Tomosynthesis|"3-dimensional breast imaging
Digital Breast Tomosynthesis"
2341|NCT02786004|B1|Baseline|Full Field Digital Mammography|"2-dimensional breast imaging
Full Field Digital Mammography"
2342|NCT02786004|P2|Participant Flow|Digital Breast Tomosynthesis|"3-dimensional breast imaging
Digital Breast Tomosynthesis"
2343|NCT02786004|P1|Participant Flow|Full Field Digital Mammography|"2-dimensional breast imaging
Full Field Digital Mammography"
2344|NCT02786004|O2|Outcome|Digital Breast Tomosynthesis|"3-dimensional breast imaging
Digital Breast Tomosynthesis"
2345|NCT02786004|O1|Outcome|Full Field Digital Mammography|"2-dimensional breast imaging
Full Field Digital Mammography"
2346|NCT02786004|E2|Reported Event|Digital Breast Tomosynthesis|"3-dimensional breast imaging
Digital Breast Tomosynthesis"
2347|NCT02786004|E1|Reported Event|Full Field Digital Mammography|"2-dimensional breast imaging
Full Field Digital Mammography"
2348|NCT02784925|B1|Baseline|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure
and has proven to be an accurate technique to measure subcutaneous fat thickness."
2349|NCT02784925|P1|Participant Flow|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure
and has proven to be an accurate technique to measure subcutaneous fat thickness."
2350|NCT02784925|O1|Outcome|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure
and has proven to be an accurate technique to measure subcutaneous fat thickness."
2351|NCT02784925|E1|Reported Event|Fatty Liver Subjects|Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
2352|NCT02780622|B1|Baseline|All Participants|Participants were randomized to 1 of 2 treatment sequences: warfarin then oseltamivir 75 mg and warfarin; or oseltamivir 75 mg and warfarin then warfarin.
2353|NCT02780622|P2|Participant Flow|First Warfarin and Oseltamivir Then Warfarin|Participants received oseltamivir 75 mg (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received warfarin (on Days 1-5) in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study.
2354|NCT02780622|P1|Participant Flow|First Warfarin Then Warfarin and Oseltamivir|Participants received warfarin (on Days 1-5) in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received oseltamivir 75 milligram (mg) (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study.
2355|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2356|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2687|NCT02755805|B3|Baseline|Total|Total of all reporting groups
2857|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
2357|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2358|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2359|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2360|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2361|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2362|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2363|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2364|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2365|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2366|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2367|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2368|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2369|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2370|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2371|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2372|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2373|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2374|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2375|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2376|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2377|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2378|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2379|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2380|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2381|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2382|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2383|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2384|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2385|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2386|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2387|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2388|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2389|NCT02780622|E2|Reported Event|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
2390|NCT02780622|E1|Reported Event|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
2839|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
2391|NCT02777268|B1|Baseline|All Study Participants|"5-way crossover study design involving Infacort and hydrocortisone at the following dose strengths:
Infacort 0.5mg Infacort 2mg Infacort 5mg Infacort 10mg Hydrocortisone 10mg
Each IMP was administered to each subject in a randomised, crossover manner over 5 treatment periods (1 treatment/period). During each treatment period, each subject was admitted to the Unit on the afternoon of Day 1 and remained in the Unit until completion of all scheduled assessments on Day 2. Each subject received their scheduled IMP on the morning of Day 2 at ~0700hrs (fasted). Each subject also received 1mg dexamethasone (to suppress endogenous cortisol production) at approximately 2200hrs on Day 1, and at approximately 0600hrs and 1200hrs on Day 2. All doses were administered with 200mL water. There were at least 7 days washout between each dose of IMP."
2392|NCT02777268|P1|Participant Flow|All Study Participants|"5-way crossover study design involving Infacort and hydrocortisone at the following dose strengths:
Infacort 0.5mg Infacort 2mg Infacort 5mg Infacort 10mg Hydrocortisone 10mg
Each IMP was administered to each subject in a randomised, crossover manner over 5 treatment periods (1 treatment/period). During each treatment period, each subject was admitted to the Unit on the afternoon of Day 1 and remained in the Unit until completion of all scheduled assessments on Day 2. Each subject received their scheduled IMP on the morning of Day 2 at ~0700hrs (fasted). Each subject also received 1mg dexamethasone (to suppress endogenous cortisol production) at approximately 2200hrs on Day 1, and at approximately 0600hrs and 1200hrs on Day 2. All doses were administered with 200mL water. There were at least 7 days washout between each dose of IMP."
2393|NCT02777268|O1|Outcome|All Study Participants|"5-way crossover study design involving Infacort and hydrocortisone at the following dose strengths:
Infacort 0.5mg Infacort 2mg Infacort 5mg Infacort 10mg Hydrocortisone 10mg
Each IMP was administered to each subject in a randomised, crossover manner over 5 treatment periods (1 treatment/period). During each treatment period, each subject was admitted to the Unit on the afternoon of Day 1 and remained in the Unit until completion of all scheduled assessments on Day 2. Each subject received their scheduled IMP on the morning of Day 2 at ~0700hrs (fasted). Each subject also received 1mg dexamethasone (to suppress endogenous cortisol production) at approximately 2200hrs on Day 1, and at approximately 0600hrs and 1200hrs on Day 2. All doses were administered with 200mL water. There were at least 7 days washout between each dose of IMP."
2394|NCT02777268|O4|Outcome|Infacort 10 mg|"Multi-particulate granules from 1 (10 mg) capsule
Infacort: Multi-particulate granules"
2395|NCT02777268|O3|Outcome|Infacort 5 mg|"Multi-particulate granules from 1 (5 mg) capsule
Infacort: Multi-particulate granules"
2396|NCT02777268|O2|Outcome|Infacort 2 mg|"Multi-particulate granules from 1 (2 mg) capsule
Infacort: Multi-particulate granules"
2397|NCT02777268|O1|Outcome|Infacort 0.5 mg|"Multi-particulate granules from 1 (0.5 mg) capsule
Infacort: Multi-particulate granules"
2398|NCT02777268|O4|Outcome|Infacort 10 mg|"Multi-particulate granules from 1 (10 mg) capsule
Infacort: Multi-particulate granules"
2399|NCT02777268|O3|Outcome|Infacort 5 mg|"Multi-particulate granules from 1 (5 mg) capsule
Infacort: Multi-particulate granules"
2400|NCT02777268|O2|Outcome|Infacort 2 mg|"Multi-particulate granules from 1 (2 mg) capsule
Infacort: Multi-particulate granules"
2401|NCT02777268|O1|Outcome|Infacort 0.5 mg|"Multi-particulate granules from 1 (0.5 mg) capsule
Infacort: Multi-particulate granules"
2402|NCT02777268|O4|Outcome|Infacort 10mg|"Multi-particulate granules from 1 (10mg) capsule
Infacort: Multi-particulate granules"
2403|NCT02777268|O3|Outcome|Infacort 5mg|"Multi-particulate granules from 1 (5mg) capsule
Infacort: Multi-particulate granules"
2404|NCT02777268|O2|Outcome|Infacort 2mg|"Multi-particulate granules from 1 (2mg) capsule
Infacort: Multi-particulate granules"
2405|NCT02777268|O1|Outcome|Infacort 0.5mg|"Multi-particulate granules from 1 (0.5 mg) capsule
Infacort: Multi-particulate granules"
2406|NCT02777268|O2|Outcome|Hydrocortisone|1 (10 mg) hydrocortisone tablet
2407|NCT02777268|O1|Outcome|Infacort 10 mg|Multi-particulate granules from 1 Infacort 10 mg capsule
2408|NCT02777268|O2|Outcome|Hydrocortisone|10 mg hydrocortisone tablet
2409|NCT02777268|O1|Outcome|Infacort 10mg|Multi-particulate granules from a 10mg Infacort capsule.
2410|NCT02777268|O2|Outcome|Hydrocortisone|"1 (10 mg) tablet
Hydrocortisone: Tablet"
2411|NCT02777268|O1|Outcome|Infacort 10mg|Multi-particulate granules from 10mg Infacort capsule
2412|NCT02777268|E5|Reported Event|Hydrocortisone|"1 (10 mg) tablet
Hydrocortisone: Tablet"
2413|NCT02777268|E4|Reported Event|Infacort 10 mg|"Multi-particulate granules from 1 (10 mg) capsule
Infacort: Multi-particulate granules"
2414|NCT02777268|E3|Reported Event|Infacort 5 mg|"Multi-particulate granules from 1 (5 mg) capsule
Infacort: Multi-particulate granules"
2415|NCT02777268|E2|Reported Event|Infacort 2 mg|"Multi-particulate granules from 1 (2 mg) capsule
Infacort: Multi-particulate granules"
2416|NCT02777268|E1|Reported Event|Infacort 0.5 mg|"Multi-particulate granules from 1 (0.5 mg) capsule
Infacort: Multi-particulate granules"
2417|NCT02777125|B3|Baseline|Total|Total of all reporting groups
2418|NCT02777125|B2|Baseline|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. The device settings were changed to provide continuous nebulization with a facemask if the patient could not breath actuate. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths."
2419|NCT02777125|B1|Baseline|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
2420|NCT02777125|P2|Participant Flow|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. The device settings were changed to provide continuous nebulization with a facemask if the patient could not breath actuate. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths."
2421|NCT02777125|P1|Participant Flow|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
2422|NCT02777125|O2|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT changed the device setting to continuous nebulization, provided an appropriately sized mask, and returned upon completion of the treatment. Albuterol dosing was based upon the subject’s weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
2423|NCT02777125|O1|Outcome|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
2424|NCT02777125|O2|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT changed the device setting to continuous nebulization, provided an appropriately sized mask, and returned upon completion of the treatment. Albuterol dosing was based upon the subject’s weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
2425|NCT02777125|O1|Outcome|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
2426|NCT02777125|O2|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT changed the device setting to continuous nebulization, provided an appropriately sized mask, and returned upon completion of the treatment. Albuterol dosing was based upon the subject’s weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
2427|NCT02777125|O1|Outcome|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
2546|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
2840|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
2460|NCT02770625|B1|Baseline|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2461|NCT02770625|P1|Participant Flow|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
4256|NCT02684942|E2|Reported Event|Fentanyl|Analyze in fentanyl group.
2428|NCT02777125|O2|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT changed the device setting to continuous nebulization, provided an appropriately sized mask, and returned upon completion of the treatment. Albuterol dosing was based upon the subject’s weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
2429|NCT02777125|O1|Outcome|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
2430|NCT02777125|O2|Outcome|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. The device settings were changed to provide continuous nebulization with a facemask if the patient could not breath actuate. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths."
2431|NCT02777125|O1|Outcome|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
2432|NCT02777125|E2|Reported Event|Albuterol Breath Actuated Nebulizer|"Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to breath actuate, the RT attached an appropriately sized mask to the device, changed the setting to continuous nebulization and returned upon completion of the treatment. Albuterol dosing was based upon the subject’s weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be atta"
2433|NCT02777125|E1|Reported Event|Albuterol by Metered Dose Inhaler|"Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths."
2434|NCT02774278|B1|Baseline|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
2435|NCT02774278|P1|Participant Flow|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
2436|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
2437|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
2438|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
2439|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
2440|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
2441|NCT02774278|E1|Reported Event|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
2841|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
2455|NCT02772666|B1|Baseline|All Study Participants|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
2456|NCT02772666|P1|Participant Flow|All Study Participants|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
2457|NCT02772666|O2|Outcome|Swinging Flashlight Test|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with manual swinging flashlight test(SFT).
2458|NCT02772666|O1|Outcome|O-Glass|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with O-Glass.
2459|NCT02772666|E1|Reported Event|All Study Participants|This diagnostic intervention is just an inspection and taking picture of the eye.
2462|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2463|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2464|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2465|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2466|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2467|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2468|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2469|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2470|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2471|NCT02770625|O1|Outcome|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2472|NCT02770625|E1|Reported Event|ISU302|"60 U/kg (once every 2 weeks for 6 months)
ISU302: 60 U/kg given intravenously"
2473|NCT02767843|B1|Baseline|Treatment|"continuous negative external pressure (cNEP) at various negative pressures
continuous negative external pressure (cNEP): soft silicone collar placed on the anterior neck, to which a negative pressure is introduced"
2474|NCT02767843|P1|Participant Flow|Subjects|Only four subjects completed the study.
2475|NCT02767843|O1|Outcome|Subjects|Only four subjects were entered into the study. No efficacy data could be analyzed because of technical problems with the data collection equipment.
2476|NCT02767843|O1|Outcome|Subjects|Only four subjects were entered into the study.
2477|NCT02767843|O1|Outcome|Subjects|Only four subjects were entered into the study. None had outcome measure (2) collected because of technical problems with data collection. Thus no interpretable data were collected.
2478|NCT02767843|E1|Reported Event|All Subjects|Only four subjects completed the study.
2479|NCT02767765|B1|Baseline|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
2515|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
2547|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
2480|NCT02767765|P1|Participant Flow|Recombinant Human Erythropoietin Beta (r-HuEPO)|Anemic cancer participants received r-HuEPO (NeoRecormon) as subcutaneous (SC) or intramuscular (IM) injection for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
2481|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
2482|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
2483|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
2484|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
2485|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
2486|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
2487|NCT02767765|E1|Reported Event|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
2488|NCT02766400|B3|Baseline|Total|Total of all reporting groups
2503|NCT02766244|O2|Outcome|Patient 1 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
ICG/SPY: indocyanine green fluorescence imaging
Antibiotic Ointment: Antibiotic ointment"
2504|NCT02766244|O1|Outcome|Patient 1 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
ICG/SPY: indocyanine green fluorescence imaging
Antibiotic Ointment: Antibiotic ointment"
4501|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
2489|NCT02766400|B2|Baseline|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.
Directed Training"
2490|NCT02766400|B1|Baseline|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.
Guided Training"
2491|NCT02766400|P2|Participant Flow|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.
Directed Training"
2492|NCT02766400|P1|Participant Flow|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.
Guided Training"
2493|NCT02766400|O2|Outcome|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.
Directed Training"
2842|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
2494|NCT02766400|O1|Outcome|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.
Guided Training"
2495|NCT02766400|E2|Reported Event|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.
Directed Training"
2496|NCT02766400|E1|Reported Event|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.
Guided Training"
2497|NCT02766244|B1|Baseline|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
ICG/SPY: indocyanine green fluorescence imaging
Antibiotic Ointment: Antibiotic ointment"
2498|NCT02766244|P1|Participant Flow|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
ICG/SPY: indocyanine green fluorescence imaging
Antibiotic Ointment: Antibiotic ointment"
2499|NCT02766244|O6|Outcome|Patient 3 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
ICG/SPY: indocyanine green fluorescence imaging
Antibiotic Ointment: Antibiotic ointment"
2500|NCT02766244|O5|Outcome|Patient 3 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
ICG/SPY: indocyanine green fluorescence imaging
Antibiotic Ointment: Antibiotic ointment"
2501|NCT02766244|O4|Outcome|Patient 2 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
ICG/SPY: indocyanine green fluorescence imaging
Antibiotic Ointment: Antibiotic ointment"
2502|NCT02766244|O3|Outcome|Patient 2 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
ICG/SPY: indocyanine green fluorescence imaging
Antibiotic Ointment: Antibiotic ointment"
4502|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
2505|NCT02766244|E1|Reported Event|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
ICG/SPY: indocyanine green fluorescence imaging
Antibiotic Ointment: Antibiotic ointment"
2506|NCT02765269|B3|Baseline|Total|Total of all reporting groups
2507|NCT02765269|B2|Baseline|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
2508|NCT02765269|B1|Baseline|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.
Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
2509|NCT02765269|P2|Participant Flow|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
2510|NCT02765269|P1|Participant Flow|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.
Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
2511|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
2512|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.
Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
2513|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
2514|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.
Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
2843|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
2516|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.
Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
2517|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
2518|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.
Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
2519|NCT02765269|E2|Reported Event|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
2520|NCT02765269|E1|Reported Event|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.
Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
2521|NCT02763189|B3|Baseline|Total|Total of all reporting groups
2522|NCT02763189|B2|Baseline|Mentored|"Mentored group will study the learning materials and then receive expert mentoring
Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.
Self-study: All subjects will receive self-study"
2523|NCT02763189|B1|Baseline|Control|"Control group will study the learning material independently. 'Self-study'.
Self-study: All subjects will receive self-study"
2524|NCT02763189|P2|Participant Flow|Mentored|"Mentored group will study the learning materials and then receive expert mentoring
Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.
Self-study: All subjects will receive self-study"
2525|NCT02763189|P1|Participant Flow|Control|"Control group will study the learning material independently. 'Self-study'.
Self-study: All subjects will receive self-study"
2526|NCT02763189|O2|Outcome|Mentored|"Mentored group will study the learning materials and then receive expert mentoring
Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.
Self-study: All subjects will receive self-study"
2527|NCT02763189|O1|Outcome|Control|"Control group will study the learning material independently. 'Self-study'.
Self-study: All subjects will receive self-study"
2528|NCT02763189|O2|Outcome|Mentored|"Mentored group will study the learning materials and then receive expert mentoring
Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.
Self-study: All subjects will receive self-study"
2529|NCT02763189|O1|Outcome|Control|"Control group will study the learning material independently. 'Self-study'.
Self-study: All subjects will receive self-study"
2530|NCT02763189|E2|Reported Event|Mentored|"Mentored group will study the learning materials and then receive expert mentoring
Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.
Self-study: All subjects will receive self-study"
2531|NCT02763189|E1|Reported Event|Control|"Control group will study the learning material independently. 'Self-study'.
Self-study: All subjects will receive self-study"
2532|NCT02761733|B5|Baseline|Total|Total of all reporting groups
2533|NCT02761733|B4|Baseline|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
2534|NCT02761733|B3|Baseline|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
2535|NCT02761733|B2|Baseline|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
2536|NCT02761733|B1|Baseline|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
2537|NCT02761733|P4|Participant Flow|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
2538|NCT02761733|P3|Participant Flow|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
2539|NCT02761733|P2|Participant Flow|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
2540|NCT02761733|P1|Participant Flow|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
2541|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
2542|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
2543|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
2544|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
2545|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
2635|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
2548|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
2549|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
2550|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
2551|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
2552|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
2553|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
2554|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
2555|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
2556|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
2557|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
2558|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
2559|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
2560|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
2561|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
2562|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
2563|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
2564|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
2565|NCT02761733|E4|Reported Event|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
2566|NCT02761733|E3|Reported Event|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
4257|NCT02684942|E1|Reported Event|Meperidine|Analyze in meperidine group.
2567|NCT02761733|E2|Reported Event|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
2568|NCT02761733|E1|Reported Event|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
2569|NCT02761629|B3|Baseline|Total|Total of all reporting groups
2570|NCT02761629|B2|Baseline|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2571|NCT02761629|B1|Baseline|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2572|NCT02761629|P2|Participant Flow|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2573|NCT02761629|P1|Participant Flow|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received peg-interferon alpha-2A (Peg-IFN-Alpha-2A) and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 micrograms (mcg) once weekly via subcutaneous injection. Ribavirin was administered as either 1000 milligrams (mg) per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing less than (<) 75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing greater than or equal to (>/=) 75 kg.
2574|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2575|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2576|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2577|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2578|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2579|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2580|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2581|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2582|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2583|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
4258|NCT02684630|B3|Baseline|Total|Total of all reporting groups
2584|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2585|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2586|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2587|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2588|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2589|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2590|NCT02761629|E2|Reported Event|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2636|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
2591|NCT02761629|E1|Reported Event|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
2592|NCT02760810|B1|Baseline|Narafilcon A|All subjects wore the same lens throughout the study.
2593|NCT02760810|P1|Participant Flow|Narafilcon A|All subjects wore the same lens throughout the study.
2594|NCT02760810|O1|Outcome|Narafilcon A|All subjects wore the same lens throughout the study.
2595|NCT02760810|O1|Outcome|Narafilcon A|All subjects wore the same lens throughout the study.
2596|NCT02760810|O1|Outcome|Narafilcon A|All subjects wore the same lens throughout the study.
2597|NCT02760810|E1|Reported Event|Narafilcon A|All subjects wore the same lens throughout the study.
2598|NCT02760654|B3|Baseline|Total|Total of all reporting groups
2599|NCT02760654|B2|Baseline|Control|Treatment as usual
2600|NCT02760654|B1|Baseline|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2601|NCT02760654|P2|Participant Flow|Control|Treatment as usual
2602|NCT02760654|P1|Participant Flow|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2603|NCT02760654|O2|Outcome|Control|Treatment as usual
2604|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2605|NCT02760654|O2|Outcome|Control|Treatment as usual
2606|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2607|NCT02760654|O2|Outcome|Control|Treatment as usual
2608|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2609|NCT02760654|O2|Outcome|Control|Treatment as usual
2610|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2611|NCT02760654|O2|Outcome|Control|Treatment as usual
2612|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2613|NCT02760654|O2|Outcome|Control|Treatment as usual
2665|NCT02756624|P1|Participant Flow|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 0.24%"
2614|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2615|NCT02760654|O2|Outcome|Control|Treatment as usual
2616|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2617|NCT02760654|O2|Outcome|Control|Treatment as usual
2618|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2619|NCT02760654|O2|Outcome|Control|Treatment as usual
2620|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2621|NCT02760654|O2|Outcome|Control|Treatment as usual
2622|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2623|NCT02760654|E2|Reported Event|Control|Treatment as usual
2624|NCT02760654|E1|Reported Event|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
Proactive Self Management Program for Effects of Cancer Treatment"
2625|NCT02759692|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
2626|NCT02759692|P2|Participant Flow|Stenfilcon A/ Senofilcon A/ Stenfilcon A|subjects randomized to this sequence received the stenfilcon A lens during the first period, the senofilcon A lens during the second period and the stenfilcon A lens during the third period.
2627|NCT02759692|P1|Participant Flow|Senofilcon A/ Stenfilcon A/ Senofilcon A|Subjects randomized to this sequence received the senofilcon A lens during the first period, the stenfilcon A lens during the second period and the senofilcon A lens during the third period.
2628|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
2629|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
2630|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
2631|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
2632|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
2633|NCT02759692|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A lens during any of the three study periods.
2634|NCT02759692|O2|Outcome|Stenfilcon A|Subjects that received the stenfilcon A lens during any three of the study periods.
2642|NCT02759471|B1|Baseline|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).
comfilcon A sphere lens (control): contact lens
comfilcon A asphere lens (test): contact lens"
2643|NCT02759471|P1|Participant Flow|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).
comfilcon A sphere lens (control): contact lens
comfilcon A asphere lens (test): contact lens"
2644|NCT02759471|O1|Outcome|Investigator Rating of Fit Preference|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
2645|NCT02759471|O2|Outcome|Comfilcon A Asphere (Test)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
2646|NCT02759471|O1|Outcome|Comfilcon A Sphere (Control)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
2647|NCT02759471|O2|Outcome|Comfilcon A Asphere (Test)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
2648|NCT02759471|O1|Outcome|Comfilcon A Sphere (Control)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
2649|NCT02759471|O2|Outcome|Comfilcon A Asphere (Test)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
2650|NCT02759471|O1|Outcome|Comfilcon A Sphere (Control)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
2651|NCT02759471|E1|Reported Event|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).
comfilcon A sphere lens (control): contact lens
comfilcon A asphere lens (test): contact lens"
2652|NCT02756637|B3|Baseline|Total|Total of all reporting groups
2653|NCT02756637|B2|Baseline|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
2654|NCT02756637|B1|Baseline|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
2655|NCT02756637|P2|Participant Flow|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
2656|NCT02756637|P1|Participant Flow|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
2657|NCT02756637|O2|Outcome|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
2658|NCT02756637|O1|Outcome|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
2659|NCT02756637|E2|Reported Event|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
2660|NCT02756637|E1|Reported Event|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
2661|NCT02756624|B3|Baseline|Total|Total of all reporting groups
2662|NCT02756624|B2|Baseline|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 Vehicle"
2663|NCT02756624|B1|Baseline|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 0.24%"
2664|NCT02756624|P2|Participant Flow|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 Vehicle"
4511|NCT02670473|O3|Outcome|Somewhat Dissatisfied|
2666|NCT02756624|O2|Outcome|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 Vehicle"
2667|NCT02756624|O1|Outcome|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 0.24%"
2668|NCT02756624|O2|Outcome|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 Vehicle"
2669|NCT02756624|O1|Outcome|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 0.24%"
2670|NCT02756624|O2|Outcome|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 Vehicle"
2671|NCT02756624|O1|Outcome|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 0.24%"
2672|NCT02756624|O2|Outcome|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 Vehicle"
2673|NCT02756624|O1|Outcome|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 0.24%"
2674|NCT02756624|E2|Reported Event|AC-170 Vehicle|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 Vehicle"
2675|NCT02756624|E1|Reported Event|AC-170 0.24%|"1 drop in each eye 3 times daily for up to 6 weeks
AC-170 0.24%"
2676|NCT02756351|B3|Baseline|Total|Total of all reporting groups
2677|NCT02756351|B2|Baseline|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.
Inspiration Healthcare Inspire nCPAP Nasal Prong"
2678|NCT02756351|B1|Baseline|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.
CytaCoat Nasal Prong"
2679|NCT02756351|P2|Participant Flow|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.
Inspiration Healthcare Inspire nCPAP Nasal Prong"
2680|NCT02756351|P1|Participant Flow|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.
CytaCoat Nasal Prong"
2681|NCT02756351|O2|Outcome|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.
Inspiration Healthcare Inspire nCPAP Nasal Prong"
2682|NCT02756351|O1|Outcome|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.
CytaCoat Nasal Prong"
2683|NCT02756351|O2|Outcome|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.
Inspiration Healthcare Inspire nCPAP Nasal Prong"
2684|NCT02756351|O1|Outcome|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.
CytaCoat Nasal Prong"
2685|NCT02756351|E2|Reported Event|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.
Inspiration Healthcare Inspire nCPAP Nasal Prong"
2686|NCT02756351|E1|Reported Event|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.
CytaCoat Nasal Prong"
2688|NCT02755805|B2|Baseline|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control"
2689|NCT02755805|B1|Baseline|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP"
2690|NCT02755805|P2|Participant Flow|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control"
2691|NCT02755805|P1|Participant Flow|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP"
2692|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control"
2693|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP"
2694|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control"
2695|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP"
2727|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
4512|NCT02670473|O2|Outcome|Somewhat Satisfied|
2696|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control"
2697|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP"
2698|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control"
2699|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP"
2700|NCT02755805|E2|Reported Event|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.
Attention Control"
2701|NCT02755805|E1|Reported Event|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
CO-OP"
2702|NCT02753699|B4|Baseline|Total|Total of all reporting groups
2703|NCT02753699|B3|Baseline|From Study 2211|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
2704|NCT02753699|B2|Baseline|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
2705|NCT02753699|B1|Baseline|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
2706|NCT02753699|P3|Participant Flow|From Study 2211|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
2707|NCT02753699|P2|Participant Flow|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
2708|NCT02753699|P1|Participant Flow|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
2709|NCT02753699|O4|Outcome|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
2710|NCT02753699|O3|Outcome|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
2711|NCT02753699|O2|Outcome|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
2712|NCT02753699|O1|Outcome|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
2713|NCT02753699|O4|Outcome|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
2714|NCT02753699|O3|Outcome|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
2715|NCT02753699|O2|Outcome|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
2716|NCT02753699|O1|Outcome|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
2717|NCT02753699|E4|Reported Event|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
2718|NCT02753699|E3|Reported Event|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
2719|NCT02753699|E2|Reported Event|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
2720|NCT02753699|E1|Reported Event|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
2721|NCT02753413|B3|Baseline|Total|Total of all reporting groups
2722|NCT02753413|B2|Baseline|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2723|NCT02753413|B1|Baseline|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2724|NCT02753413|P2|Participant Flow|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2725|NCT02753413|P1|Participant Flow|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2726|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
4313|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
2728|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2729|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2730|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2731|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2732|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2733|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2734|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2735|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2736|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2737|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2738|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2739|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2740|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2741|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2742|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2743|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2744|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2745|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2746|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2747|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2748|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2749|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2750|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2751|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2752|NCT02753413|O2|Outcome|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2753|NCT02753413|O1|Outcome|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2754|NCT02753413|E2|Reported Event|Boostrix Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2755|NCT02753413|E1|Reported Event|GSK3003891A Group|Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
2756|NCT02753075|B4|Baseline|Total|Total of all reporting groups
2795|NCT02752802|O1|Outcome|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
2757|NCT02753075|B3|Baseline|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2758|NCT02753075|B2|Baseline|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2759|NCT02753075|B1|Baseline|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2760|NCT02753075|P3|Participant Flow|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2761|NCT02753075|P2|Participant Flow|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2762|NCT02753075|P1|Participant Flow|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 minute (min) and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 milliliter (mL) of Experimental Oral Rinse 1 (1.5% weight by weight [w/w] dipotassium oxalate monohydrate [KOX], 0 parts per million [ppm] fluoride [F]) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2763|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2764|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2765|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2844|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
2845|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
2766|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2767|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2768|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2769|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2770|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2771|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2772|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2773|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
4314|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
2774|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm fluoride F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2775|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2776|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2777|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm fluoride F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2778|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2779|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2780|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2781|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2782|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2783|NCT02753075|E3|Reported Event|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2784|NCT02753075|E2|Reported Event|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F, pH 4.5) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2785|NCT02753075|E1|Reported Event|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 minute (min) and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 milliliter (mL) of Experimental Oral Rinse 1 (1.5% weight by weight [w/w] dipotassium oxalate monohydrate [KOX], 0 parts per million [ppm] fluoride [F], pH 4.5) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
2786|NCT02752802|B3|Baseline|Total|Total of all reporting groups
2787|NCT02752802|B2|Baseline|Control|"The control group will include standard of care for diagnostic coronary angiograms.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
2788|NCT02752802|B1|Baseline|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
2789|NCT02752802|P2|Participant Flow|Control|"The control group will include standard of care for diagnostic coronary angiograms.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
2790|NCT02752802|P1|Participant Flow|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
2791|NCT02752802|O1|Outcome|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
2792|NCT02752802|O2|Outcome|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
2793|NCT02752802|O1|Outcome|Control|"The control group will include standard of care for diagnostic coronary angiograms.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
2794|NCT02752802|O2|Outcome|Control|"The control group will include standard of care for diagnostic coronary angiograms.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
2906|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
2796|NCT02752802|E2|Reported Event|Control|"The control group will include standard of care for diagnostic coronary angiograms.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
2797|NCT02752802|E1|Reported Event|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
2798|NCT02751450|B3|Baseline|Total|Total of all reporting groups
2799|NCT02751450|B2|Baseline|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2800|NCT02751450|B1|Baseline|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2801|NCT02751450|P2|Participant Flow|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2802|NCT02751450|P1|Participant Flow|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million, ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2803|NCT02751450|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2804|NCT02751450|O1|Outcome|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2805|NCT02751450|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2806|NCT02751450|O1|Outcome|Stannous Fluoride Dentifice|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2807|NCT02751450|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2808|NCT02751450|O1|Outcome|Stannous Fluoride Dentifice|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2809|NCT02751450|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2907|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
2908|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
2909|NCT02750332|E2|Reported Event|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
2810|NCT02751450|O1|Outcome|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2811|NCT02751450|E2|Reported Event|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2812|NCT02751450|E1|Reported Event|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
2813|NCT02750943|B3|Baseline|Total|Total of all reporting groups
2814|NCT02750943|B2|Baseline|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2815|NCT02750943|B1|Baseline|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2816|NCT02750943|P2|Participant Flow|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2817|NCT02750943|P1|Participant Flow|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2818|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2819|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2820|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2821|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2846|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
2847|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
2822|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2823|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2824|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2825|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2826|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2827|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2828|NCT02750943|E2|Reported Event|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2829|NCT02750943|E1|Reported Event|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
2830|NCT02750709|B1|Baseline|All Study Participants|
2910|NCT02750332|E1|Reported Event|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
2911|NCT02750267|B3|Baseline|Total|Total of all reporting groups
2831|NCT02750709|P6|Participant Flow|Treatment Sequence C (Reference) - B (TP 2) - A (TP 1)|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
2832|NCT02750709|P5|Participant Flow|Treatment Sequence C (Reference) - A (TP 1) - B (TP 2)|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
2833|NCT02750709|P4|Participant Flow|Treatment Sequence B (TP 2) - C (Reference) - A (TP 1)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
2834|NCT02750709|P3|Participant Flow|Treatment Sequence B (TP 2) - A (TP 1) - C (Reference)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
2835|NCT02750709|P2|Participant Flow|Treatment Sequence A (TP 1) - C (Reference) - B (TP 2)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
2836|NCT02750709|P1|Participant Flow|Treatment Sequence A (TP 1) - B (TP 2) - C (Reference)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
2837|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
2838|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
2858|NCT02750709|E3|Reported Event|Reference Product|ORFADIN® hard capsule, 10 mg
2859|NCT02750709|E2|Reported Event|Test Product 2|Nitisinone Tablet (High Compritol), 10 mg
2860|NCT02750709|E1|Reported Event|Test Product 1|Nitisinone Tablet, 10 mg
2861|NCT02750345|B1|Baseline|All Study Participants|Grouped by all participants as this is how overall data has been collected.
2862|NCT02750345|P6|Participant Flow|Sequence Reference - TP 2 - TP 1|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 2, and 10 mg tablet of Nitisinone (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.
Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
2863|NCT02750345|P5|Participant Flow|Sequence Reference - TP 1 - TP 2|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.
Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
2864|NCT02750345|P4|Participant Flow|Sequence TP 2 - Reference - TP 1|"Subjects will receive a single 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.
Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
4513|NCT02670473|O1|Outcome|Completely Satisfied|
2865|NCT02750345|P3|Participant Flow|Sequence TP 2 - TP 1 - Reference|"Subjects will receive a single 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.
Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
2866|NCT02750345|P2|Participant Flow|Sequence TP 1 - Reference - TP 2|"Subjects will receive a single 10 mg tablet of Nitisinone (Test Product 1) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.
Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
2867|NCT02750345|P1|Participant Flow|Sequence TP 1 - TP 2 - Reference|"Subjects will receive a single 10 mg tablet of Nitisinone (Test Product 1 (TP 1)) in treatment period 1, 10 mg tablet of Nitisinone Baked Tablet (Test Product 2 (TP 2)) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.
Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.
Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
2868|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
2869|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
2870|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
2871|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
2872|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
2873|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
2874|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
2875|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
2876|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
2877|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
2878|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
2879|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
2880|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
2881|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
2882|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
2883|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
2884|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
2885|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
2886|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
2887|NCT02750345|O2|Outcome|Test Product 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
2888|NCT02750345|O1|Outcome|Test Product 1|10 mg Nitisinone Tablet
2889|NCT02750345|E3|Reported Event|Reference Product|ORFADIN®, 10 mg hard capsule
2890|NCT02750345|E2|Reported Event|Test Product 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
2891|NCT02750345|E1|Reported Event|Test Product 1|10 mg Nitisinone Tablet
2892|NCT02750332|B1|Baseline|All Study Participants|
2919|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
2893|NCT02750332|P2|Participant Flow|Treatment Sequence B (Fasted) - A (Fed)|"Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fasting conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fed conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered."
2894|NCT02750332|P1|Participant Flow|Treatment Sequence A (Fed) - B (Fasted)|"Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fed conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered."
2895|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
2896|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
2897|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
2898|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
2899|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
2900|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
2901|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
2902|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
2903|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
2904|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
2905|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
2912|NCT02750267|B2|Baseline|Group B- Closed-Loop Control Before Home Care|"Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.
Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
2913|NCT02750267|B1|Baseline|Group A- Home Care Before Closed-Loop Control|"In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.
Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
2914|NCT02750267|P2|Participant Flow|Group B- Closed-Loop Control Before Home Care|"Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.
Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
2915|NCT02750267|P1|Participant Flow|Group A- Home Care Before Closed-Loop Control|"In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.
Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours."
2916|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
2917|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
2918|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
2920|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
2921|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
2922|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
2923|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
2924|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
2925|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
2926|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
2927|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
2928|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
2929|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
4315|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
2930|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
2931|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
2932|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
2933|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
2934|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
2935|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
2936|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
2937|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
2938|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
2939|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
2940|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
2941|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
8014|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
2942|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
2943|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
2944|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
2945|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
2946|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
2947|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
2948|NCT02750267|O2|Outcome|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
2949|NCT02750267|O1|Outcome|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
2950|NCT02750267|E2|Reported Event|Diabetes Assistant (DiAs) With Closed-Loop Control|All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
2951|NCT02750267|E1|Reported Event|Home Care (Pump+CGM)|All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
2952|NCT02748213|B3|Baseline|Total|Total of all reporting groups
2953|NCT02748213|B2|Baseline|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
2954|NCT02748213|B1|Baseline|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
2955|NCT02748213|P2|Participant Flow|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
2956|NCT02748213|P1|Participant Flow|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via intravenous (IV) infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 milligrams per kilogram (mg/kg) in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 milligrams per meter-squared (mg/m^2), with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
2957|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
2958|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
2959|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
2974|NCT02746679|P2|Participant Flow|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
2960|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
2961|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
2962|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
2963|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
2964|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
2965|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
2966|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
2967|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
2968|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
2969|NCT02748213|E2|Reported Event|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
2970|NCT02748213|E1|Reported Event|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
2971|NCT02746679|B3|Baseline|Total|Total of all reporting groups
2972|NCT02746679|B2|Baseline|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
2973|NCT02746679|B1|Baseline|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
3042|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
2975|NCT02746679|P1|Participant Flow|MBSR Group|"The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
Mindfulness Based Stress Reduction: Mindfulness Based Stress Reduction programs have been shown to be effective, however, the potential benefits of Mindfulness Based Stress Reduction to decrease depression, anxiety, stress in other diseases. Therefore, the purpose of this"
2976|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
2977|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
2978|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
2979|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
2980|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
4316|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
2981|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
2982|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
2983|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
2984|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
2985|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
2986|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
2987|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
2988|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
3043|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
2989|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
2990|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
2991|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
2992|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
2993|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
2994|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
3019|NCT02746107|O2|Outcome|Two Diagrams|"classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)
decision aid: decision aid with one/two diagrams"
4321|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
2995|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
2996|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
2997|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
2998|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
2999|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
3000|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
3001|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
3002|NCT02746679|E2|Reported Event|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
3044|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3045|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
8015|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
3003|NCT02746679|E1|Reported Event|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
3004|NCT02746406|B1|Baseline|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter
Peritron+: Peritron+ device to measure intravesical pressure"
3005|NCT02746406|P1|Participant Flow|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter
Peritron+: Peritron+ device to measure intravesical pressure"
3006|NCT02746406|O1|Outcome|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter
Peritron+: Peritron+ device to measure intravesical pressure"
3007|NCT02746406|E1|Reported Event|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter
Peritron+: Peritron+ device to measure intravesical pressure"
3008|NCT02746107|B1|Baseline|All Participants|all participants in the study (968)
3009|NCT02746107|P1|Participant Flow|All Study Participants|all study participants were 968 (in all arms of this factorial RCT)
3010|NCT02746107|O5|Outcome|CHA2D2S-VASC Risk Score 5|
3011|NCT02746107|O4|Outcome|CHA2D2S-VASC Risk Score 4|
3012|NCT02746107|O3|Outcome|CHA2D2S-VASC Risk Score 3|
3013|NCT02746107|O2|Outcome|CHA2D2S-VASC Risk Score 2|
3014|NCT02746107|O1|Outcome|CHA2D2S-VASC Risk Score 1|
3015|NCT02746107|O2|Outcome|Prescription to Physician Himself|the participants had to imagine that they had atrial fibrillation, the risk from the diagram was theirs, and had to decide to take or not the OACs
3016|NCT02746107|O1|Outcome|Prescription to Patient|the participant physician were randomized to prescribe OAC to virtual patients
3017|NCT02746107|O2|Outcome|1 Year Risk Estimation on DA (CHA2D2S-VASC Score)|participants deciding to prescribe or not OAC after seeing the stroke risk estimation on 1 year (classical CHA2D2S-VASC score)
3018|NCT02746107|O1|Outcome|5 Years Risk Estimation on DA|participants had to prescribe or not OAC after seeing the risk estimated on 5 years
3020|NCT02746107|O1|Outcome|One Diagram|"decision aid with one diagram (risk under treatment)
decision aid: decision aid with one/two diagrams"
3021|NCT02746107|E2|Reported Event|Two Diagrams|"classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)
decision aid: decision aid with one/two diagrams
OAC prescribed: 406 of 482 (83.5%)"
3022|NCT02746107|E1|Reported Event|One Diagram|"decision aid with one diagram (risk under treatment)
decision aid: decision aid with one/two diagrams
OAC prescribed: 400 of 486 (83%)"
3023|NCT02745626|B4|Baseline|Total|Total of all reporting groups
3024|NCT02745626|B3|Baseline|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3025|NCT02745626|B2|Baseline|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3026|NCT02745626|B1|Baseline|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3027|NCT02745626|P3|Participant Flow|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3028|NCT02745626|P2|Participant Flow|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3029|NCT02745626|P1|Participant Flow|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3030|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3031|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3032|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3033|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3034|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3035|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3036|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3037|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3038|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3039|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3040|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3041|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
4296|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
3046|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3047|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3048|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3049|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3050|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3051|NCT02745626|E3|Reported Event|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3052|NCT02745626|E2|Reported Event|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3053|NCT02745626|E1|Reported Event|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California
Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
3054|NCT02743702|B3|Baseline|Total|Total of all reporting groups
3055|NCT02743702|B2|Baseline|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.
USUAL THERAPIES"
3056|NCT02743702|B1|Baseline|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.
RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:
supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times
lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side
sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing
diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his"
3077|NCT02743780|B3|Baseline|MGV354 0.1%|MGV354 ophthalmic suspension 0.1%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2 and Part 3)
3057|NCT02743702|P2|Participant Flow|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.
USUAL THERAPIES"
3058|NCT02743702|P1|Participant Flow|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.
RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:
supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times
lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side
sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing
diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his"
3059|NCT02743702|O2|Outcome|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.
USUAL THERAPIES"
3060|NCT02743702|O1|Outcome|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. Sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.
RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:
supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times
lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side
sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing
diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou"
3061|NCT02743702|E2|Reported Event|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.
USUAL THERAPIES"
3062|NCT02743702|E1|Reported Event|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for 1 year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.
RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:
supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times
lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side
sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing
diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou"
3063|NCT02743936|B3|Baseline|Total|Total of all reporting groups
3064|NCT02743936|B2|Baseline|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula
Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
3065|NCT02743936|B1|Baseline|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.
Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
3066|NCT02743936|P2|Participant Flow|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula
Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
3067|NCT02743936|P1|Participant Flow|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.
Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
3068|NCT02743936|O2|Outcome|NIPPV Without Nasal Cannula|"Non-invasive positive pressure ventilation without nasal cannula
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
3069|NCT02743936|O1|Outcome|NIPPV With Nasal Cannula|"Non-invasive positive pressure ventilation with nasal cannula in place
Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
3070|NCT02743936|O2|Outcome|NIPPV Without Nasal Cannula|"Non-invasive positive pressure ventilation without nasal cannula
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
3071|NCT02743936|O1|Outcome|NIPPV With Nasal Cannula|"Non-invasive positive pressure ventilation with nasal cannula in place
Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
3072|NCT02743936|E2|Reported Event|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula
Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
3073|NCT02743936|E1|Reported Event|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.
Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask
Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
3074|NCT02743780|B6|Baseline|Total|Total of all reporting groups
3075|NCT02743780|B5|Baseline|Placebo|Placebo, 1 drop in the study eye (Part 1); 1 drop in each eye for 7 days (Part 2 and Part 3)
3076|NCT02743780|B4|Baseline|MGV354 0.3%|MGV354 ophthalmic suspension 0.3%, 1 drop in the study eye (Part 1)
3078|NCT02743780|B2|Baseline|MGV354 0.03%|MGV354 ophthalmic suspension 0.03%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2)
3079|NCT02743780|B1|Baseline|MGV354 0.01%|MGV354 ophthalmic suspension 0.01%, 1 drop in the study eye (Part 1)
3080|NCT02743780|P5|Participant Flow|Placebo|Placebo, 1 drop in the study eye (Part 1); 1 drop in each eye for 7 days (Part 2 and Part 3)
3081|NCT02743780|P4|Participant Flow|MGV354 0.3%|MGV354 ophthalmic suspension 0.3%, 1 drop in the study eye (Part 1)
3082|NCT02743780|P3|Participant Flow|MGV354 0.1%|MGV354 ophthalmic suspension 0.1%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2 and Part 3)
3083|NCT02743780|P2|Participant Flow|MGV354 0.03%|MGV354 ophthalmic suspension 0.03%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2)
3084|NCT02743780|P1|Participant Flow|MGV354 0.01%|MGV354 ophthalmic suspension 0.01%, 1 drop in the study eye (Part 1)
3085|NCT02743780|O1|Outcome|MGV354 0.1%|Part 3: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 2, 1 drop in each eye for 7 days
3086|NCT02743780|O2|Outcome|MGV354 0.1%|Part 2: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 1, 1 drop in each eye for 7 days
3087|NCT02743780|O1|Outcome|MGV354 0.03%|Part 2: MGV354 0.03% ophthalmic suspension, next lowest dose from the maximum tolerated dose (MTD) concentration from Part 1, 1 drop in each eye for 7 days
3088|NCT02743780|O2|Outcome|MGV354 0.1%|Part 2: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 1, 1 drop in each eye for 7 days
3089|NCT02743780|O1|Outcome|MGV354 0.03%|Part 2: MGV354 0.03% ophthalmic suspension, next lowest dose from the maximum tolerated dose (MTD) concentration from Part 1, 1 drop in each eye for 7 days
3090|NCT02743780|O2|Outcome|MGV354 0.1%|Part 2: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 1, 1 drop in each eye for 7 days
3091|NCT02743780|O1|Outcome|MGV354 0.03%|Part 2: MGV354 0.03% ophthalmic suspension, next lowest dose from the maximum tolerated dose (MTD) concentration from Part 1, 1 drop in each eye for 7 days
3092|NCT02743780|O2|Outcome|MGV354 0.1%|Part 2: MGV354 0.1% ophthalmic suspension, MTD concentration determined from Part 1, 1 drop in each eye for 7 days
3093|NCT02743780|O1|Outcome|MGV354 0.03%|Part 2: MGV354 0.03% ophthalmic suspension, next lowest dose from the maximum tolerated dose (MTD) concentration from Part 1, 1 drop in each eye for 7 days
3094|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
3095|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
3096|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
3097|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
3098|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
3099|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
3100|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
3101|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
3102|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
3103|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
3104|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
3105|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
3106|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
3107|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
3108|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
3109|NCT02743780|O3|Outcome|MGV354 0.3%|Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
3110|NCT02743780|O2|Outcome|MGV354 0.1%|Part 1: MGV354 0.1% ophthalmic suspension, 1 drop in the study eye
3111|NCT02743780|O1|Outcome|MGV354 0.03%|Part 1: MGV354 0.03% ophthalmic suspension, 1 drop in the study eye
3112|NCT02743780|O2|Outcome|Placebo|Part 3: MGV354 placebo, 1 drop in each eye for 7 days
3113|NCT02743780|O1|Outcome|MGV354 0.1%|Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
3114|NCT02743780|O2|Outcome|Placebo|Part 3: MGV354 placebo, 1 drop in each eye for 7 days
3115|NCT02743780|O1|Outcome|MGV354 0.1%|Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
3116|NCT02743780|O2|Outcome|Placebo|Part 3: MGV354 placebo, 1 drop in each eye for 7 days
3117|NCT02743780|O1|Outcome|MGV354 0.1%|Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
3118|NCT02743780|E10|Reported Event|Placebo Part 3|1 drop in each eye for 7 days
3119|NCT02743780|E9|Reported Event|MGV354 0.1% Part 3|1 drop in each eye for 7 days
3120|NCT02743780|E8|Reported Event|Placebo Part 2|1 drop in each eye for 7 days
3121|NCT02743780|E7|Reported Event|MGV354 0.1% Part 2|1 drop in each eye for 7 days
3122|NCT02743780|E6|Reported Event|MGV354 0.03% Part 2|1 drop in each eye for 7 days
3123|NCT02743780|E5|Reported Event|Placebo Part 1|1 drop in the study eye
3124|NCT02743780|E4|Reported Event|MGV354 0.3% Part 1|1 drop in the study eye
3125|NCT02743780|E3|Reported Event|MGV354 0.1% Part 1|1 drop in the study eye
3126|NCT02743780|E2|Reported Event|MGV354 0.03% Part 1|1 drop in the study eye
3127|NCT02743780|E1|Reported Event|MGV354 0.01% Part 1|1 drop in the study eye
3128|NCT02742987|B3|Baseline|Total|Total of all reporting groups
3129|NCT02742987|B2|Baseline|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy
Clopidogrel: Clopidogrel 150 mg once daily
Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
3237|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
4322|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
3130|NCT02742987|B1|Baseline|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy
Ticagrelor: Ticagrelor 90 mg twice daily
Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
3131|NCT02742987|P2|Participant Flow|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy
Clopidogrel: Clopidogrel 150 mg once daily
Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
3132|NCT02742987|P1|Participant Flow|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy
Ticagrelor: Ticagrelor 90 mg twice daily
Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
3133|NCT02742987|O2|Outcome|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy
Clopidogrel: Clopidogrel 150 mg once daily
Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
3134|NCT02742987|O1|Outcome|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy
Ticagrelor: Ticagrelor 90 mg twice daily
Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
3135|NCT02742987|E2|Reported Event|Clopidogrel Group|"Clopidogrel 150 mg once daily + standard medical therapy
Clopidogrel: Clopidogrel 150 mg once daily
Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
3136|NCT02742987|E1|Reported Event|Ticagrelor Group|"Ticagrelor 90 mg twice daily + standard medical therapy
Ticagrelor: Ticagrelor 90 mg twice daily
Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions"
3137|NCT02739698|B3|Baseline|Total|Total of all reporting groups
3138|NCT02739698|B2|Baseline|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).
Paclitaxel
Radical surgery-peritonectomy (ovarian carcinomatosis)"
3139|NCT02739698|B1|Baseline|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).
Paclitaxel
Radical surgery-peritonectomy (ovarian carcinomatosis)"
3140|NCT02739698|P2|Participant Flow|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).
Paclitaxel
Radical surgery-peritonectomy (ovarian carcinomatosis)"
3141|NCT02739698|P1|Participant Flow|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).
Paclitaxel
Radical surgery-peritonectomy (ovarian carcinomatosis)"
3142|NCT02739698|O2|Outcome|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).
Paclitaxel
Radical surgery-peritonectomy"
3143|NCT02739698|O1|Outcome|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).
Paclitaxel
Radical surgery-peritonectomy"
3144|NCT02739698|E2|Reported Event|Hyperthermic (41-42ºC)|"Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC).
Paclitaxel
Radical surgery-peritonectomy (ovarian carcinomatosis)"
3145|NCT02739698|E1|Reported Event|Normothermic (36-37ºC)|"Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).
Paclitaxel
Radical surgery-peritonectomy (ovarian carcinomatosis)"
3146|NCT02739594|B3|Baseline|Total|Total of all reporting groups
8016|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
3147|NCT02739594|B2|Baseline|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3148|NCT02739594|B1|Baseline|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3149|NCT02739594|P2|Participant Flow|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3150|NCT02739594|P1|Participant Flow|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3151|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3152|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3153|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3154|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3155|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3156|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3157|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3158|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3159|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3160|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3161|NCT02739594|O1|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3162|NCT02739594|O1|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3163|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3164|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
8017|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
3165|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3166|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3167|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3168|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3169|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3170|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3171|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3172|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3173|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3174|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3175|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3176|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3177|NCT02739594|E2|Reported Event|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3178|NCT02739594|E1|Reported Event|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
3179|NCT02737852|B1|Baseline|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks
Trojan Chameleon Personal Lubricant: silicone base with sensate"
3180|NCT02737852|P1|Participant Flow|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks
Trojan Chameleon Personal Lubricant: silicone base with sensate"
3181|NCT02737852|O1|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks
Trojan Chameleon Personal Lubricant: silicone base with sensate"
3182|NCT02737852|O1|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks
Trojan Chameleon Personal Lubricant: silicone base with sensate"
3183|NCT02737852|E1|Reported Event|Healthy Subject|"Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks
Trojan Chameleon Personal Lubricant: silicone base with sensate"
3184|NCT02737592|B1|Baseline|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks
Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
3185|NCT02737592|P1|Participant Flow|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks
Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
8018|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
3186|NCT02737592|O1|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks
Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
3187|NCT02737592|O1|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks
Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
3188|NCT02737592|E1|Reported Event|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks
Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
3189|NCT02736721|B1|Baseline|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
3190|NCT02736721|P1|Participant Flow|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544 (NCT number not available), NO16006 (NCT number not available) or ML17228 (NCT number not available) and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 microgram (mcg) once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
3191|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
3192|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
3193|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
4514|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
3194|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
3195|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
3196|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
3197|NCT02736721|E1|Reported Event|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
3198|NCT02735200|B3|Baseline|Total|Total of all reporting groups
3199|NCT02735200|B2|Baseline|Application of Aloe Vera Gel|Intervention: aloe vera gel administration 1 gram
3200|NCT02735200|B1|Baseline|Topical Application of Vitamin D3|this arm received topical vitamin D3 1gram (5000IU)
3201|NCT02735200|P2|Participant Flow|Topical Application of Vitamin D3|topical vitamin D3 in intervention group: local application of Top-D, 1 gram (5000 IU) was applied every day, for 120 days.
3202|NCT02735200|P1|Participant Flow|Application of Aloe Vera Gel|Intervention: aloe vera gel administration was applied 1 gram daily for 120 days.
3203|NCT02735200|O2|Outcome|Application of Aloe Vera Gel|Intervention: aloe vera gel administration
3204|NCT02735200|O1|Outcome|Topical Application of Vitamin D3|"Intervention: patients will be administered topical vitamin D3 5000 IU
topical vitamin D3 in intervention group: local application"
3205|NCT02735200|E2|Reported Event|Application of Aloe Vera Gel|"Intervention: aloe vera gel administration
topical vitamin D3 in intervention group: local application"
3206|NCT02735200|E1|Reported Event|Topical Application of Vitamin D3|"Intervention: patients will be administered topical vitamin D3 5000 IU
topical vitamin D3 in intervention group: local application"
3207|NCT02734355|B3|Baseline|Total|Total of all reporting groups
3208|NCT02734355|B2|Baseline|Placebo|"Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
Placebo (for telmisartan and amlodipine): Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet"
3209|NCT02734355|B1|Baseline|Therapy|"Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
Telmisartan 80 mg and amlodipine 5 mg"
3210|NCT02734355|P2|Participant Flow|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3211|NCT02734355|P1|Participant Flow|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3212|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3213|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3214|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3215|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3216|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3217|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3218|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3219|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3220|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3221|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3222|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3223|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3224|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3225|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3226|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3227|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3228|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3229|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3230|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3231|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3232|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3233|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3234|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3235|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3236|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
4515|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
3238|NCT02734355|E2|Reported Event|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
3239|NCT02734355|E1|Reported Event|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
3240|NCT02734212|B3|Baseline|Total|Total of all reporting groups
3241|NCT02734212|B2|Baseline|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
3242|NCT02734212|B1|Baseline|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
3243|NCT02734212|P2|Participant Flow|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
3244|NCT02734212|P1|Participant Flow|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
3245|NCT02734212|O2|Outcome|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
3246|NCT02734212|O1|Outcome|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
3247|NCT02734212|O2|Outcome|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
3248|NCT02734212|O1|Outcome|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
3249|NCT02734212|O2|Outcome|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
3276|NCT02732561|P2|Participant Flow|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device
Alpha Stim device: cranial electrotherapy stimulation device"
3250|NCT02734212|O1|Outcome|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
3251|NCT02734212|E2|Reported Event|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
3252|NCT02734212|E1|Reported Event|Ending Self-Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
3253|NCT02734056|B3|Baseline|Total|Total of all reporting groups
3254|NCT02734056|B2|Baseline|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.
Control: Control"
3255|NCT02734056|B1|Baseline|Music|"The intervention to be administered is music
Music: Listening to music that the patient likes"
3256|NCT02734056|P2|Participant Flow|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.
Control: Control"
3257|NCT02734056|P1|Participant Flow|Music|"The intervention to be administered is music
Music: Listening to music that the patient likes"
3258|NCT02734056|O2|Outcome|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.
Control: Control"
3259|NCT02734056|O1|Outcome|Music|"The intervention to be administered is music
Music: Listening to music that the patient likes"
3260|NCT02734056|E2|Reported Event|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.
Control: Control"
4503|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
3261|NCT02734056|E1|Reported Event|Music|"The intervention to be administered is music
Music: Listening to music that the patient likes"
3262|NCT02732639|B1|Baseline|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
3263|NCT02732639|P1|Participant Flow|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
3264|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
3265|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
3266|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
3267|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
3268|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
3269|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
3270|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
3271|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
3272|NCT02732639|E1|Reported Event|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
3273|NCT02732561|B3|Baseline|Total|Total of all reporting groups
3274|NCT02732561|B2|Baseline|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device
Alpha Stim device: cranial electrotherapy stimulation device"
3275|NCT02732561|B1|Baseline|Sham Device|"Sham device
Sham device: Sham device"
3277|NCT02732561|P1|Participant Flow|Sham Device|"Sham device
Sham device: Sham device"
3278|NCT02732561|O2|Outcome|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device
Alpha Stim device: cranial electrotherapy stimulation device"
3279|NCT02732561|O1|Outcome|Sham Device|"Sham device
Sham device: Sham device"
3280|NCT02732561|O2|Outcome|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device
Alpha Stim device: cranial electrotherapy stimulation device"
3281|NCT02732561|O1|Outcome|Sham Device|"Sham device
Sham device: Sham device"
3282|NCT02732561|E2|Reported Event|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device
Alpha Stim device: cranial electrotherapy stimulation device"
3283|NCT02732561|E1|Reported Event|Sham Device|"Sham device
Sham device: Sham device"
3284|NCT02732327|B3|Baseline|Total|Total of all reporting groups
3285|NCT02732327|B2|Baseline|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
3286|NCT02732327|B1|Baseline|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
3287|NCT02732327|P2|Participant Flow|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
3288|NCT02732327|P1|Participant Flow|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
3289|NCT02732327|O2|Outcome|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
3290|NCT02732327|O1|Outcome|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
3291|NCT02732327|E2|Reported Event|Standard of Care+Vancomycin or Linezolid|Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
3292|NCT02732327|E1|Reported Event|CAZ-AVI + Vancomycin or Linezolid|Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care [SOC]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug.
3293|NCT02732210|B3|Baseline|Total|Total of all reporting groups
3294|NCT02732210|B2|Baseline|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
3295|NCT02732210|B1|Baseline|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
3296|NCT02732210|P2|Participant Flow|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
3297|NCT02732210|P1|Participant Flow|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
3298|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
3299|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
3300|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
3301|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
8019|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
3302|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
3303|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
3304|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
3305|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
3306|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
3307|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
3308|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
3309|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
3310|NCT02732210|E2|Reported Event|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
3311|NCT02732210|E1|Reported Event|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
3312|NCT02731833|B3|Baseline|Total|Total of all reporting groups
3333|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
3313|NCT02731833|B2|Baseline|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3314|NCT02731833|B1|Baseline|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3315|NCT02731833|P2|Participant Flow|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3316|NCT02731833|P1|Participant Flow|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3317|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3318|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3319|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3320|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3321|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3322|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3323|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3324|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3491|NCT02717754|P4|Participant Flow|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
3325|NCT02731833|E2|Reported Event|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3326|NCT02731833|E1|Reported Event|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3327|NCT02731313|B1|Baseline|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma Samples|"Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
Trastuzumab: Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions."
3328|NCT02731313|P1|Participant Flow|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
3329|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
3330|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
3331|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
3332|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
3334|NCT02731313|E1|Reported Event|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
3335|NCT02731300|B3|Baseline|Total|Total of all reporting groups
3336|NCT02731300|B2|Baseline|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex"
3337|NCT02731300|B1|Baseline|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex"
3338|NCT02731300|P2|Participant Flow|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex"
3339|NCT02731300|P1|Participant Flow|Active tDCS|"2 milliampere (mA) of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex"
3340|NCT02731300|O2|Outcome|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex"
3341|NCT02731300|O1|Outcome|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex"
3342|NCT02731300|O2|Outcome|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex"
3343|NCT02731300|O1|Outcome|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex"
3344|NCT02731300|E2|Reported Event|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex"
3345|NCT02731300|E1|Reported Event|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex"
3346|NCT02731131|B3|Baseline|Total|Total of all reporting groups
3347|NCT02731131|B2|Baseline|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
3348|NCT02731131|B1|Baseline|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
3349|NCT02731131|P2|Participant Flow|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 milligrams (mg) per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
3350|NCT02731131|P1|Participant Flow|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
3351|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
3352|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
3353|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
3354|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
3492|NCT02717754|P3|Participant Flow|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3355|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
3356|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
3357|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
3358|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
3359|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
3360|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
3361|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
3362|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
3406|NCT02725788|B2|Baseline|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
3407|NCT02725788|B1|Baseline|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
3363|NCT02731131|E2|Reported Event|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
3364|NCT02731131|E1|Reported Event|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
3365|NCT02730260|B3|Baseline|Total|Total of all reporting groups
3366|NCT02730260|B2|Baseline|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.
Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
3367|NCT02730260|B1|Baseline|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.
Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
3368|NCT02730260|P2|Participant Flow|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.
Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
3369|NCT02730260|P1|Participant Flow|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.
Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
3370|NCT02730260|O2|Outcome|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.
Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
3371|NCT02730260|O1|Outcome|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.
Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
3372|NCT02730260|E2|Reported Event|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.
Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
3373|NCT02730260|E1|Reported Event|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.
Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
3374|NCT02726971|B3|Baseline|Total|Total of all reporting groups
3375|NCT02726971|B2|Baseline|6mg Estradiol Therapy(High Dose)|"mean Age(y):32.3 Gender:Female BMI:21.0 mean Number of miscarriage: 2.1
BMI=body mass index"
3376|NCT02726971|B1|Baseline|2mg Estradiol Therapy(Low Dose)|"mean Age(y):31.9 Gender:Female BMI:21.2 mean Number of miscarriage: 2.3
BMI=body mass index"
3377|NCT02726971|P2|Participant Flow|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.
Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
3378|NCT02726971|P1|Participant Flow|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.
Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
3379|NCT02726971|O2|Outcome|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.
Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
3380|NCT02726971|O1|Outcome|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.
Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
3381|NCT02726971|O2|Outcome|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.
Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
3382|NCT02726971|O1|Outcome|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.
Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
3383|NCT02726971|O2|Outcome|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.
Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
3384|NCT02726971|O1|Outcome|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.
Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
3385|NCT02726971|E2|Reported Event|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.
Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
3386|NCT02726971|E1|Reported Event|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.
Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
3387|NCT02726178|B3|Baseline|Total|Total of all reporting groups
3388|NCT02726178|B2|Baseline|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.
The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.
Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
3408|NCT02725788|P2|Participant Flow|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
3409|NCT02725788|P1|Participant Flow|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
3389|NCT02726178|B1|Baseline|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.
The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.
Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
3390|NCT02726178|P2|Participant Flow|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.
The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.
Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
3391|NCT02726178|P1|Participant Flow|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.
The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.
Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
3392|NCT02726178|O2|Outcome|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.
The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.
Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
3393|NCT02726178|O1|Outcome|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.
The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.
Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
3394|NCT02726178|E2|Reported Event|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.
The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.
Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
3395|NCT02726178|E1|Reported Event|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.
The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.
Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
3396|NCT02726022|B1|Baseline|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
3397|NCT02726022|P1|Participant Flow|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a (Pegasys) and ribavirin (Copegus) for four weeks, were observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
3398|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
3399|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
3493|NCT02717754|P2|Participant Flow|Oseltamivir 100 mg|Participants received 100 milligrams (mg) oseltamivir intravenous BID for 5 days.
3494|NCT02717754|P1|Participant Flow|Placebo|Participants received oseltamivir matched placebo twice daily (BID) for 5 days.
3400|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
3401|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
3402|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
3403|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
3404|NCT02726022|E1|Reported Event|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
3405|NCT02725788|B3|Baseline|Total|Total of all reporting groups
4504|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
3410|NCT02725788|O2|Outcome|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
3411|NCT02725788|O1|Outcome|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
3412|NCT02725788|E2|Reported Event|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
3413|NCT02725788|E1|Reported Event|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
3414|NCT02724449|B1|Baseline|Cavilon Advanced Barrier Film|"Cavilon Advanced Barrier Film applied to areas of IAD
Cavilon Advanced Barrier Film: Cavilon Advanced Barrier Fim's application applied twice a week"
3415|NCT02724449|P1|Participant Flow|Open-label Study|No competitive products evaluated.
3416|NCT02724449|O1|Outcome|Open Label Study|
3417|NCT02724449|E1|Reported Event|Open-label Study|Single arm study
3418|NCT02723188|B4|Baseline|Total|Total of all reporting groups
3419|NCT02723188|B3|Baseline|AC: Alternating Current|"Alternating current electrical stimulation
AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
3420|NCT02723188|B2|Baseline|DC: Direct Current|"Direct current electrical stimulation
DC stimulation (1.5 milliampere, 20 minutes)"
3421|NCT02723188|B1|Baseline|Sham|"Sham electrical stimulation
Sham stimulation (1.5 milliampere,30 seconds)"
3422|NCT02723188|P3|Participant Flow|AC (Alternating Current)|"Alternating current electrical stimulation
AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
3423|NCT02723188|P2|Participant Flow|DC (Direct Current)|"Direct current electrical stimulation
DC stimulation (1.5 milliampere, 20 minutes)"
3424|NCT02723188|P1|Participant Flow|Sham|"Sham electrical stimulation
Sham stimulation (1.5 milliampere,30 seconds)"
3425|NCT02723188|O3|Outcome|AC: Alternating Current|"Alternating current electrical stimulation
AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
3426|NCT02723188|O2|Outcome|DC: Direct Current|"Direct current electrical stimulation
DC stimulation (1.5 milliampere, 20 minutes)"
3427|NCT02723188|O1|Outcome|Sham|"Sham electrical stimulation
Sham stimulation (1.5 milliampere,30 seconds)"
3428|NCT02723188|O3|Outcome|AC: Alternating Current|"Alternating current electrical stimulation
AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
3429|NCT02723188|O2|Outcome|DC: Direct Current|"Direct current electrical stimulation
DC stimulation (1.5 milliampere, 20 minutes)"
3430|NCT02723188|O1|Outcome|Sham|"Sham electrical stimulation
Sham stimulation (1.5 milliampere,30 seconds)"
3431|NCT02723188|E3|Reported Event|AC: Alternating Current|"Alternating current electrical stimulation
AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
3432|NCT02723188|E2|Reported Event|DC: Direct Current|"Direct current electrical stimulation
DC stimulation (1.5 milliampere, 20 minutes)"
3433|NCT02723188|E1|Reported Event|Sham|"Sham electrical stimulation
Sham stimulation (1.5 milliampere,30 seconds)"
3434|NCT02722564|B1|Baseline|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested
self estimation of breath alcohol content
record breath alcohol content as measured by breathalyzer
drink a beer: drink a beer, repeat until breath alcohol content 0.1"
3435|NCT02722564|P1|Participant Flow|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested
self estimation of breath alcohol content
record breath alcohol content as measured by breathalyzer
drink a beer: drink a beer, repeat until breath alcohol content 0.1"
3436|NCT02722564|O1|Outcome|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested
self estimation of breath alcohol content
record breath alcohol content as measured by breathalyzer
drink a beer: drink a beer, repeat until breath alcohol content 0.1"
3437|NCT02722564|E1|Reported Event|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested
self estimation of breath alcohol content
record breath alcohol content as measured by breathalyzer
drink a beer: drink a beer, repeat until breath alcohol content 0.1"
8020|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
3438|NCT02721641|B1|Baseline|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
3439|NCT02721641|P1|Participant Flow|Herceptin|Participants received intravenous (IV) Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 milligrams per kilogram (mg/kg) once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
3440|NCT02721641|O1|Outcome|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
3441|NCT02721641|O1|Outcome|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
3442|NCT02721641|O1|Outcome|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
3443|NCT02721641|E1|Reported Event|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
3444|NCT02721277|B1|Baseline|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3445|NCT02721277|P1|Participant Flow|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3446|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3447|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3448|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
8021|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
3449|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3450|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3590|NCT02713594|P1|Participant Flow|Control|Participants in the Control condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.
3654|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
4505|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
3451|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3452|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3453|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3454|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3455|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3495|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3496|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3497|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3498|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3499|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3500|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3456|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3457|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3458|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3459|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3460|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3461|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3462|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3501|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3502|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3503|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3504|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3505|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3506|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3463|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3464|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3465|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3466|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3467|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3468|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3469|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3507|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3508|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3509|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3510|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3511|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3512|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3470|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3471|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3472|NCT02721277|E1|Reported Event|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
3473|NCT02720952|B1|Baseline|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).
The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.
Infacort®: dry granule formulation of hydrocortisone"
3474|NCT02720952|P1|Participant Flow|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).
The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.
Infacort®: dry granule formulation of hydrocortisone"
3475|NCT02720952|O4|Outcome|Question 4|Percentage of parents/carers that agreed, or strongly agreed with the statement: Overall, I would prefer Infacort for my child over the usual hydrocortisone medication.
3476|NCT02720952|O3|Outcome|Question 3|Percentage of parents/carers that agreed, or strongly agreed with the statement: I would be happy to give my child Infacort in the future.
3477|NCT02720952|O2|Outcome|Question 2|Percentage of parents/carers that agreed, or strongly agreed with the statement: My child showed a positive reaction after Infacort was given.
3478|NCT02720952|O1|Outcome|Question 1|Percentage of parents/carers that agreed, or strongly agreed with the statement: My child found swallowing easy.
3479|NCT02720952|O1|Outcome|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).
The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.
Infacort®: dry granule formulation of hydrocortisone"
3480|NCT02720952|O1|Outcome|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).
The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.
Infacort®: dry granule formulation of hydrocortisone"
3481|NCT02720952|E1|Reported Event|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).
The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.
Infacort®: dry granule formulation of hydrocortisone"
3482|NCT02717754|B7|Baseline|Total|Total of all reporting groups
3483|NCT02717754|B6|Baseline|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
3484|NCT02717754|B5|Baseline|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
3485|NCT02717754|B4|Baseline|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
3486|NCT02717754|B3|Baseline|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3487|NCT02717754|B2|Baseline|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3488|NCT02717754|B1|Baseline|Placebo|Participants received oseltamivir matched placebo BID for 5 days.
3489|NCT02717754|P6|Participant Flow|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
3490|NCT02717754|P5|Participant Flow|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
8022|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
3513|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3514|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3515|NCT02717754|E6|Reported Event|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
3516|NCT02717754|E5|Reported Event|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
3517|NCT02717754|E4|Reported Event|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
3518|NCT02717754|E3|Reported Event|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
3519|NCT02717754|E2|Reported Event|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
3520|NCT02717754|E1|Reported Event|Placebo|Participants received oseltamivir matched placebo for 5 days.
3521|NCT02716779|B4|Baseline|Total|Total of all reporting groups
3642|NCT02708524|P2|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3643|NCT02708524|P1|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
4506|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
3522|NCT02716779|B3|Baseline|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3523|NCT02716779|B2|Baseline|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3524|NCT02716779|B1|Baseline|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3525|NCT02716779|P3|Participant Flow|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3526|NCT02716779|P2|Participant Flow|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3527|NCT02716779|P1|Participant Flow|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3577|NCT02716298|O5|Outcome|Strongly Prefer Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study
lotrafilcon B: contact lens"
3578|NCT02716298|O4|Outcome|Slightly Prefer Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study
lotrafilcon B: contact lens"
3579|NCT02716298|O3|Outcome|No Preference|
3580|NCT02716298|O2|Outcome|Slightly Prefer Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study
fanfilcon A: contact lens"
4297|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
3528|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3644|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
3645|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
3646|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
4507|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
3529|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3530|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3531|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3532|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3533|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3534|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3535|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3581|NCT02716298|O1|Outcome|Strongly Prefer Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study
fanfilcon A: contact lens"
3582|NCT02716298|O2|Outcome|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.
lotrafilcon B: contact lens"
3583|NCT02716298|O1|Outcome|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study
fanfilcon A: contact lens"
3552|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3536|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3537|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3538|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3539|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3540|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3541|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3542|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3543|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3584|NCT02716298|E2|Reported Event|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens during the crossover study.
lotrafilcon B: contact lens"
3585|NCT02716298|E1|Reported Event|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens during the crossover study
fanfilcon A: contact lens"
3586|NCT02713594|B3|Baseline|Total|Total of all reporting groups
3587|NCT02713594|B2|Baseline|Incentive|Counseling from WTQL; Financial incentive to participate
3544|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3545|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3546|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3547|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3548|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3549|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3550|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3551|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3588|NCT02713594|B1|Baseline|Control|Counseling from WTQL
3640|NCT02708524|P4|Participant Flow|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
3641|NCT02708524|P3|Participant Flow|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
4298|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
3553|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3554|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3555|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3556|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3557|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3558|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3559|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3636|NCT02708524|B4|Baseline|Samfilcon A|All subjects that wore the samfilcon A lens throughout the duration of the study.
3637|NCT02708524|B3|Baseline|Lotrafilcon B|All subjects that wore the lotrafilcon B lens throughout the duration of the study.
3638|NCT02708524|B2|Baseline|Comfilcon A|All subjects that wore the comfilcon A lens throughout the duration of the study.
3639|NCT02708524|B1|Baseline|Senofilcon C|All subjects that wore the senofilcon C lens throughout the duration of the study.
3589|NCT02713594|P2|Participant Flow|Incentive|"Participants in the Incentive Condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.
Participants in the Incentive condition also received financial incentives to complete proactive counseling calls from the WTQL received ($30 per completed call); in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit."
4516|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
3560|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3561|NCT02716779|O3|Outcome|Total Participant Group|Combined group of PEG IFN alfa-2a, matching placebo and ribavirin arms.
3562|NCT02716779|O2|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3563|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
3564|NCT02716779|E6|Reported Event|Ribavirin, Period 2 Combination Therapy|"In period 2 participants, who received ribavirin monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
3565|NCT02716779|E5|Reported Event|Placebo, Period 2 Combination Therapy|"In period 2 participants, who received placebo in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
3566|NCT02716779|E4|Reported Event|PEG-IFN Alfa-2a, Period 2 Combination Therapy|"In period 2 participants, who received PEG-IFN monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
3567|NCT02716779|E3|Reported Event|Ribavirin, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks in period 1.
Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
3568|NCT02716779|E2|Reported Event|Placebo, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received placebo PO for 6 weeks in period 1.
Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks."
3569|NCT02716779|E1|Reported Event|PEG-IFN Alfa-2a, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks in period 1.
Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks."
3570|NCT02716298|B1|Baseline|Overall Participants|"Study participants are randomized to wear fanfilcon A lens or lotrafilcon B lens for 1 month during the crossover study
fanfilcon A: contact lens lotrafilcon B: contact lens"
3571|NCT02716298|P2|Participant Flow|Lotrafilcon B Then Fanfilcon A|"Study participants are randomized to wear lotrafilcon B for 1 month, then fanfilcon A lens for 1 month during the crossover study.
lotrafilcon B: contact lens fanfilcon A: contact lens"
3572|NCT02716298|P1|Participant Flow|Fanfilcon A Then Lotrafilcon B|"Study participants are randomized to wear fanfilcon A lens for 1 month, then lotrafilcon B for 1 month during the crossover study
fanfilcon A: contact lens lotrafilcon B: contact lens"
3573|NCT02716298|O2|Outcome|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.
lotrafilcon B: contact lens"
3574|NCT02716298|O1|Outcome|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study
fanfilcon A: contact lens"
3575|NCT02716298|O2|Outcome|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.
lotrafilcon B: contact lens"
3576|NCT02716298|O1|Outcome|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study
fanfilcon A: contact lens"
8023|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
3591|NCT02713594|O2|Outcome|Incentive|"Counseling from WTQL; Financial incentive to participate
Counseling from WTQL: Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.
Financial incentive to participate: Participants in the Incentive condition received $30 per call for up to five WTQL calls taken; in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit. (Note that participants in both the Control condition and the Incentive condition received $40 for completing the baseline biochemical smoking status assessment visit and $40 for completing the 6-month follow-up biochemical smoking status assessment visit.)"
3592|NCT02713594|O1|Outcome|Control|"Counseling from WTQL
Counseling from WTQL: Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking."
3593|NCT02713594|O2|Outcome|Incentive|Counseling from WTQL; Financial incentive to participate
3594|NCT02713594|O1|Outcome|Control|Counseling from WTQL
3595|NCT02713594|O2|Outcome|Incentive|Counseling from WTQL; Financial incentive to participate
3596|NCT02713594|O1|Outcome|Control|Counseling from WTQL
3597|NCT02713594|E2|Reported Event|Incentive|Counseling from WTQL; Financial incentive to participate
3598|NCT02713594|E1|Reported Event|Control|Counseling from WTQL
3599|NCT02712099|B3|Baseline|Total|Total of all reporting groups
3600|NCT02712099|B2|Baseline|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
When not separated easily manual removal was done, with uterotonics, together with uterine massage.
20 Women with placenta previa who had difficult placenta delivery"
3601|NCT02712099|B1|Baseline|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
30 Women with placenta previa who had easily placenta delivery"
3602|NCT02712099|P2|Participant Flow|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
When not separated easily manual removal was done, with uterotonics, together with uterine massage.
20 Women with placenta previa who had difficult placenta delivery"
3603|NCT02712099|P1|Participant Flow|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
30 Women with placenta previa who had easily placenta delivery"
3604|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
When not separated easily manual removal was done, with uterotonics, together with uterine massage.
20 Women with placenta previa who had difficult placenta delivery"
3605|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
30 Women with placenta previa who had easily placenta delivery"
3647|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3648|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
4508|NCT02670473|O2|Outcome|Fanfilcon A Lens (Test)|fanfilcon A lens (test)
3606|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
When not separated easily manual removal was done, with uterotonics, together with uterine massage.
20 Women with placenta previa who had difficult placenta delivery"
3607|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
30 Women with placenta previa who had easily placenta delivery"
3608|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
When not separated easily manual removal was done, with uterotonics, together with uterine massage.
20 Women with placenta previa who had difficult placenta delivery"
3609|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
30 Women with placenta previa who had easily placenta delivery"
3610|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
When not separated easily manual removal was done, with uterotonics, together with uterine massage.
20 Women with placenta previa who had difficult placenta delivery"
3611|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
30 Women with placenta previa who had easily placenta delivery"
3612|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
When not separated easily manual removal was done, with uterotonics, together with uterine massage.
20 Women with placenta previa who had difficult placenta delivery"
3613|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
30 Women with placenta previa who had easily placenta delivery"
8024|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
3649|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
3650|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3651|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3652|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
3653|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
3614|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
When not separated easily manual removal was done, with uterotonics, together with uterine massage.
20 Women with placenta previa who had difficult placenta delivery"
3615|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
30 Women with placenta previa who had easily placenta delivery"
3616|NCT02712099|E2|Reported Event|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
When not separated easily manual removal was done, with uterotonics, together with uterine massage.
20 Women with placenta previa who had difficult placenta delivery"
3617|NCT02712099|E1|Reported Event|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.
Intraoperative:
Delivery of the fetus through the placenta.
15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.
30 Women with placenta previa who had easily placenta delivery"
3618|NCT02709577|B3|Baseline|Total|Total of all reporting groups
3619|NCT02709577|B2|Baseline|Sham: Endoscopy and Standard of Care|"Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints.
Sham: endoscopy and standard of care: Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes"
3620|NCT02709577|B1|Baseline|EndoBarrier Gastrointestinal Liner|"Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints.
EndoBarrier Gastrointestinal Liner: The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum."
3621|NCT02709577|P4|Participant Flow|Cohort B Control Sham|Device not implanted.
3622|NCT02709577|P3|Participant Flow|Cohort A Control Sham|Device was not implanted
3623|NCT02709577|P2|Participant Flow|Cohort B:EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
3624|NCT02709577|P1|Participant Flow|Cohort A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
3625|NCT02709577|O4|Outcome|Cohort B Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation. Follow-up after treatment phase was 12 months.
3626|NCT02709577|O3|Outcome|Cohort A Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation. Follow-up after treatment phase was originally 6 months and then extended to 12 months based on physician discretion.
3627|NCT02709577|O2|Outcome|Cohort B: EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
3628|NCT02709577|O1|Outcome|Cohoart A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
3629|NCT02709577|O4|Outcome|Cohort B Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation.
3630|NCT02709577|O3|Outcome|Cohort A Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation.
3631|NCT02709577|O2|Outcome|Cohort B: EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
3632|NCT02709577|O1|Outcome|Cohort A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
3633|NCT02709577|E2|Reported Event|Cohorts A and B Sham: Endoscopy and Standard of Care|Subjects randomized to sham and underwent an endoscopy procedure and then received standard of care treatment for their diabetes
3634|NCT02709577|E1|Reported Event|Cohorts A and B: EndoBarrier Gastrointestinal Liner|Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 or 52 weeks and evaluated for study endpoints
3635|NCT02708524|B5|Baseline|Total|Total of all reporting groups
8025|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
3655|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3656|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
3657|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
3658|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3659|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3660|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
3661|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
3662|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3663|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3664|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
3665|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
3666|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3667|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3668|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
3669|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
3670|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3671|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3672|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
3673|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
3674|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3675|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3676|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
3677|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
3678|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3679|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3680|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
3681|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
3682|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3683|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3684|NCT02708524|E4|Reported Event|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
3685|NCT02708524|E3|Reported Event|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
3686|NCT02708524|E2|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3687|NCT02708524|E1|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3688|NCT02708355|B4|Baseline|Total|Total of all reporting groups
8026|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
3689|NCT02708355|B3|Baseline|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
3690|NCT02708355|B2|Baseline|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
3691|NCT02708355|B1|Baseline|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
3692|NCT02708355|P3|Participant Flow|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
3693|NCT02708355|P2|Participant Flow|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
3694|NCT02708355|P1|Participant Flow|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
3695|NCT02708355|O3|Outcome|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
3696|NCT02708355|O2|Outcome|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
3697|NCT02708355|O1|Outcome|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
3698|NCT02708355|O3|Outcome|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
3699|NCT02708355|O2|Outcome|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
3700|NCT02708355|O1|Outcome|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
3701|NCT02708355|E3|Reported Event|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
3702|NCT02708355|E2|Reported Event|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
3703|NCT02708355|E1|Reported Event|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
3704|NCT02708277|B3|Baseline|Total|Total of all reporting groups
3705|NCT02708277|B2|Baseline|Group B|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
3706|NCT02708277|B1|Baseline|Group A|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
3707|NCT02708277|P2|Participant Flow|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
3708|NCT02708277|P1|Participant Flow|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
3709|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
3710|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
3711|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
3712|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
3713|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
3714|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
3848|NCT02701556|O1|Outcome|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)
NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
3715|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
3716|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
3717|NCT02708277|E2|Reported Event|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
3718|NCT02708277|E1|Reported Event|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
3719|NCT02708238|B4|Baseline|Total|Total of all reporting groups
3720|NCT02708238|B3|Baseline|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution
Simethicone"
3721|NCT02708238|B2|Baseline|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension
Lactobacillus reuteri DSM 17938 (108 CFU)"
3722|NCT02708238|B1|Baseline|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution
Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
3723|NCT02708238|P3|Participant Flow|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution
Simethicone"
3724|NCT02708238|P2|Participant Flow|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension
Lactobacillus reuteri DSM 17938 (108 CFU)"
3725|NCT02708238|P1|Participant Flow|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution
Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
3726|NCT02708238|O3|Outcome|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution
Simethicone"
3727|NCT02708238|O2|Outcome|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension
Lactobacillus reuteri DSM 17938 (108 CFU)"
3728|NCT02708238|O1|Outcome|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution
Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
3729|NCT02708238|O3|Outcome|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution
Simethicone"
3730|NCT02708238|O2|Outcome|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension
Lactobacillus reuteri DSM 17938 (108 CFU)"
3731|NCT02708238|O1|Outcome|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution
Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
3732|NCT02708238|E3|Reported Event|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution
Simethicone"
3733|NCT02708238|E2|Reported Event|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension
Lactobacillus reuteri DSM 17938 (108 CFU)"
3734|NCT02708238|E1|Reported Event|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution
Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
3735|NCT02708212|B3|Baseline|Total|Total of all reporting groups
3736|NCT02708212|B2|Baseline|Colonoscopy-EGD Group|In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded.
4032|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
3737|NCT02708212|B1|Baseline|EGD-colonoscopy Group|In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded.
3738|NCT02708212|P2|Participant Flow|Colonoscopy-EGD Group|In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded.
3756|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3739|NCT02708212|P1|Participant Flow|EGD-colonoscopy Group|In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insullfation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded.
3740|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|The duration of both colonoscopy and EGD examinations was recorded and compared.
3741|NCT02708212|O1|Outcome|EGD-colonoscopy Group|The duration of both EGD and colonoscopy examinations was recorded and compared.
3742|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|"In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of midazolam after the completion of the bidirectional endoscopy were recorded.
EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
3743|NCT02708212|O1|Outcome|EGD-colonoscopy Group|"In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of midazolam after the completion of the bidirectional endoscopy were recorded.
EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
3744|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|"In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.
EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
3745|NCT02708212|O1|Outcome|EGD-colonoscopy Group|"In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.
EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
3746|NCT02708212|E2|Reported Event|Colonoscopy-EGD Group|Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s.
3747|NCT02708212|E1|Reported Event|EGD-colonoscopy Group|Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s.
3748|NCT02707640|B3|Baseline|Total|Total of all reporting groups
3749|NCT02707640|B2|Baseline|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3750|NCT02707640|B1|Baseline|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3751|NCT02707640|P2|Participant Flow|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3752|NCT02707640|P1|Participant Flow|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3753|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3754|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3755|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3829|NCT02705716|B3|Baseline|Total|Total of all reporting groups
3757|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3758|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3759|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3760|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3761|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3762|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3763|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3764|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3765|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3766|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3767|NCT02707640|E2|Reported Event|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3768|NCT02707640|E1|Reported Event|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
3769|NCT02707172|B1|Baseline|All Participants|"A total of 28 participants were recruited and were divided into two groups, one group receiving placebo first and then intervention, the other group receiving intervention first and then placebo.
The placebo is handwashing with water using the 6-step standardized handwashing technique.
The intervention is handwasahing with soap using the 6-step standardized handwashing technique."
3849|NCT02701556|E2|Reported Event|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)
Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
3770|NCT02707172|P1|Participant Flow|All Participants|"All participants underwent two experiments, one with placebo (handwashing with water) and one with intervention (handwashing with soap), but in different order.
28 participants underwent placebo first and crossed-over to received intervention; while the other 28 participants underwent intervention first and then placebo. There was one day wash-out period between the two sets of experiment.
In each set of the experiment, each participant was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo or intervention by a standardized hand washing technique depending on the sequence assignment.
A total of 56 placebo experiments were performed and a total of 56 intervention experiments were performed in the study."
3771|NCT02707172|O1|Outcome|All Participants|"A total of 28 participants were recruited and were divided into two groups, one group receiving placebo first and then intervention, the other group receiving intervention first and then placebo.
The placebo is handwashing with water using the 6-step standardized handwashing technique.
The intervention is handwasahing with soap using the 6-step standardized handwashing technique."
3772|NCT02707172|E2|Reported Event|Placebo|"Subject was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo, handwashing with water, by a standardized hand washing technique.
Then the subjects in this arms are crossover to perform the intervention, handwashing with soap.
handwashing with soap: handwashing with soap by a standardized 6-step handwashing technique
handwashing with water: handwashing with water by a standardized 6-step handwashing technique"
3889|NCT02701270|E3|Reported Event|Polydextrose Control|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
4317|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
3773|NCT02707172|E1|Reported Event|Intervention|"Subject was first exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the intervention, handwashing with soap, by a standardized hand washing technique.
Then the subjects in this arms are crossover to receive placebo, handwashing with water only.
handwashing with soap: handwashing with soap by a standardized 6-step handwashing technique
handwashing with water: handwashing with water by a standardized 6-step handwashing technique"
3774|NCT02706327|B4|Baseline|Total|Total of all reporting groups
3775|NCT02706327|B3|Baseline|Control|"8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
3776|NCT02706327|B2|Baseline|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3777|NCT02706327|B1|Baseline|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3778|NCT02706327|P3|Participant Flow|Control|"8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
3779|NCT02706327|P2|Participant Flow|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3780|NCT02706327|P1|Participant Flow|CAD/CAM|"8-week follow-up with computer-aided design/computer aided manufacturing (CAD/CAM) insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3781|NCT02706327|O3|Outcome|Control|"8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
3782|NCT02706327|O2|Outcome|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3783|NCT02706327|O1|Outcome|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3784|NCT02706327|O3|Outcome|Control|"8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
3785|NCT02706327|O2|Outcome|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
8027|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
3786|NCT02706327|O1|Outcome|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3787|NCT02706327|O3|Outcome|Control|"8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
3788|NCT02706327|O2|Outcome|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3858|NCT02701296|B1|Baseline|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
3789|NCT02706327|O1|Outcome|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3790|NCT02706327|O3|Outcome|Control|"8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
3791|NCT02706327|O2|Outcome|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3792|NCT02706327|O1|Outcome|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3793|NCT02706327|O3|Outcome|Control|"8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
3794|NCT02706327|O2|Outcome|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3795|NCT02706327|O1|Outcome|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3796|NCT02706327|E3|Reported Event|Control|"8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole."
3797|NCT02706327|E2|Reported Event|Semi-custom|"8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3798|NCT02706327|E1|Reported Event|CAD/CAM|"8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes."
3799|NCT02705807|B1|Baseline|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3800|NCT02705807|P1|Participant Flow|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3850|NCT02701556|E1|Reported Event|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)
NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
4186|NCT02690727|O2|Outcome|RP6530 in Fed Condition|"A single dose of RP6530 following fed condition
RP6530: Single oral dose"
3801|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3802|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3859|NCT02701296|P2|Participant Flow|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
3803|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3804|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3805|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3806|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3807|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3808|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3809|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3810|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3811|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3812|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3813|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3851|NCT02701387|B1|Baseline|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
3852|NCT02701387|P1|Participant Flow|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
3814|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3815|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3816|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3817|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3818|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3819|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3820|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3821|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3822|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3823|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3824|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3825|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3826|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3853|NCT02701387|O2|Outcome|EZ Plus Implant|"Comparative implant (Megagen EZ Plus dental implant) placed in a healed edentulous site to replace a missing tooth.
Megagen EZ Plus dental implant: EZ Plus is an approved dental implant with a standard thread design (width and depth) and that is comparable to many other dental implants currently available on the market."
8028|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
3827|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3828|NCT02705807|E1|Reported Event|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
3830|NCT02705716|B2|Baseline|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3831|NCT02705716|B1|Baseline|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3832|NCT02705716|P2|Participant Flow|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3833|NCT02705716|P1|Participant Flow|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3834|NCT02705716|O2|Outcome|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3835|NCT02705716|O1|Outcome|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3836|NCT02705716|O2|Outcome|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3837|NCT02705716|O1|Outcome|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3838|NCT02705716|O2|Outcome|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3839|NCT02705716|O1|Outcome|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3840|NCT02705716|E2|Reported Event|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3841|NCT02705716|E1|Reported Event|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
3842|NCT02701556|B3|Baseline|Total|Total of all reporting groups
3843|NCT02701556|B2|Baseline|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)
Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
3844|NCT02701556|B1|Baseline|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)
NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
3845|NCT02701556|P2|Participant Flow|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)
Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
3846|NCT02701556|P1|Participant Flow|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)
NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
3847|NCT02701556|O2|Outcome|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)
Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
3854|NCT02701387|O1|Outcome|AnyRidge Implant|"Experimental implant (Megagen AnyRidge dental implant) placed in a healed edentulous site to replace a missing tooth.
Megagen AnyRidge dental implant: AnyRidge is an approved dental implant with a knife edge, thin thread design available in various thread widths (depth)."
3855|NCT02701387|E1|Reported Event|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
3856|NCT02701296|B3|Baseline|Total|Total of all reporting groups
3857|NCT02701296|B2|Baseline|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
3887|NCT02701270|O1|Outcome|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
3888|NCT02701270|E4|Reported Event|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
3860|NCT02701296|P1|Participant Flow|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
3861|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
3862|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
3863|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
3864|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
3865|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
3866|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
3867|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
3868|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
3869|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
3870|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
3871|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
3872|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
3873|NCT02701296|E2|Reported Event|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
3874|NCT02701296|E1|Reported Event|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
3875|NCT02701270|B1|Baseline|All Study Participants|All participants received every study intervention in randomized order: Experimental Dietary Fibre 1 and 2, Polydextrose and Dextrose
3876|NCT02701270|P4|Participant Flow|Fibre 2 First, Then Polydextrose, Dextrose and Fibre1|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Dietary Fibre 2, at second visit 21.48 g Polydextrose Control, at third visit 23.89 g Dextrose Control and at fourth visit 22.17 g Dietary Fibre 1.
3877|NCT02701270|P3|Participant Flow|Fibre1 First, Then Fibre 2, Polydextrose and Dextrose|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 22.17 g Dietary Fibre 1, at second visit 21.48 g Dietary Fibre 2, at third visit 21.48 g Polydextrose Control and at fourth visit 23.89 g Dextrose Control.
3878|NCT02701270|P2|Participant Flow|Dextrose First, Then Fibre1, Fibre 2 and Polydextrose|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 23.89 g Dextrose Control, at second visit 22.17 g Dietary Fibre 1, at third visit 21.48 g Dietary Fibre 2 and at fourth visit 21.48 g Polydextrose Control.
3916|NCT02698423|P1|Participant Flow|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing."
3879|NCT02701270|P1|Participant Flow|Polydextrose First, Then Dextrose, Fibre1 and Fibre 2|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Polydextrose Control, at second visit 23.89 g Dextrose Control, at third visit 22.17 g Dietary Fibre 1 and at fourth visit 21.48 g Dietary Fibre 2.
3880|NCT02701270|O4|Outcome|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
3881|NCT02701270|O3|Outcome|Polydextrose|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
3882|NCT02701270|O2|Outcome|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
3883|NCT02701270|O1|Outcome|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
3884|NCT02701270|O4|Outcome|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
3885|NCT02701270|O3|Outcome|Polydextrose Control|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
3886|NCT02701270|O2|Outcome|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
3890|NCT02701270|E2|Reported Event|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
3891|NCT02701270|E1|Reported Event|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
3892|NCT02699892|B1|Baseline|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
3893|NCT02699892|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
3894|NCT02699892|O1|Outcome|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
3895|NCT02699892|O1|Outcome|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
3896|NCT02699892|E1|Reported Event|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
3897|NCT02699593|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
3898|NCT02699593|P2|Participant Flow|Senofilcon A(Control)/Senofilcon A(Test)|Subjects that were randomized to receive the control lens senofilcon A first and then the test lens senofilcon A lens second.
3899|NCT02699593|P1|Participant Flow|Senofilcon A(Test)/Senofilcon A(Control)|Subjects that were randomized to receive the test lens senofilcon A lens first and then the control lens senofilcon A lens second.
3900|NCT02699593|O2|Outcome|Senofilcon A (Control)|Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
3901|NCT02699593|O1|Outcome|Senofilcon A (Test)|Subjects that wore the test lens senofilcon A during either the first or second period of the study.
3902|NCT02699593|O2|Outcome|Senofilcon A (Control)|Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
3903|NCT02699593|O1|Outcome|Senofilcon A (Test)|Subjects that wore the test lens senofilcon A during either the first or second period of the study.
3904|NCT02699593|E2|Reported Event|Senofilcon A (Control)|Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
3905|NCT02699593|E1|Reported Event|Senofilcon A (Test)|Subjects that wore the test lens senofilcon A during either the first or second period of the study.
3906|NCT02698566|B1|Baseline|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
3907|NCT02698566|P1|Participant Flow|Ranibizumab Prefilled Syringe (PFS)|Healthcare professionals (HCPs) administered ITV injections of ranibizumab 0.5 milligrams (mg) delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
3908|NCT02698566|O1|Outcome|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
3909|NCT02698566|O1|Outcome|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
3910|NCT02698566|O1|Outcome|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
3911|NCT02698566|E1|Reported Event|Ranibizumab PFS|HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
3912|NCT02698423|B3|Baseline|Total|Total of all reporting groups
3913|NCT02698423|B2|Baseline|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Papanicolau test: Women will be invited to come in for a physician-performed Pap test"
3914|NCT02698423|B1|Baseline|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing"
3915|NCT02698423|P2|Participant Flow|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Papanicolau test: Women will be invited to come in for a physician-performed Pap test."
3917|NCT02698423|O2|Outcome|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Papanicolau test: Women will be invited to come in for a physician-performed Pap test.
N=331"
3918|NCT02698423|O1|Outcome|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. N=336"
3919|NCT02698423|E2|Reported Event|Papanicolau Test|"Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Papanicolau test: Women will be invited to come in for a physician-performed Pap test.
N=331"
3920|NCT02698423|E1|Reported Event|Cobas HPV DNA Test|"Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. N=336"
3921|NCT02697890|B3|Baseline|Total|Total of all reporting groups
3922|NCT02697890|B2|Baseline|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:
Device: Mucograft® seal Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
3923|NCT02697890|B1|Baseline|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:
Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
3924|NCT02697890|P2|Participant Flow|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:
Device: Mucograft® seal Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
4318|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
3925|NCT02697890|P1|Participant Flow|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:
Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
3926|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:
Device: Mucograft® seal Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
3927|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:
Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
3928|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:
Device: Mucograft® seal Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
3929|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:
Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
3930|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:
Device: Mucograft® seal Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
3931|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:
Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
3932|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:
Device: Mucograft® seal Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
3933|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:
Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
3934|NCT02697890|E2|Reported Event|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:
Device: Mucograft® seal Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
3935|NCT02697890|E1|Reported Event|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:
Procedure: Ridge preservation procedure
FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
3936|NCT02696317|B1|Baseline|Overall|Habitual contact lenses worn first, followed by senofilcon A contact lenses with HydraLuxe™ and senofilcon A contact lenses in Periods 1 and 2, as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
3937|NCT02696317|P2|Participant Flow|Habitual, AO, AO1D|Habitual contact lenses worn first, followed by senofilcon A contact lenses in Period 1, then senofilcon A contact lenses with HydraLuxe™ in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
3938|NCT02696317|P1|Participant Flow|Habitual, AO1D, AO|Habitual contact lenses worn first, followed by senofilcon A contact lenses with HydraLuxe™ in Period 1 and senofilcon A contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.
3939|NCT02696317|O2|Outcome|ACUVUE OASYS|Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
3940|NCT02696317|O1|Outcome|ACUVUE OASYS 1-DAY|Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
3941|NCT02696317|O2|Outcome|ACUVUE OASYS|Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
3942|NCT02696317|O1|Outcome|ACUVUE OASYS 1-DAY|Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
3943|NCT02696317|O2|Outcome|ACUVUE OASYS|Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
3944|NCT02696317|O1|Outcome|ACUVUE OASYS 1-DAY|Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
3945|NCT02696317|O2|Outcome|ACUVUE OASYS|Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
3946|NCT02696317|O1|Outcome|ACUVUE OASYS 1-DAY|Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality
3947|NCT02696317|E4|Reported Event|ACUVUE OASYS|All subjects exposed to ACUVUE OASYS contact lenses
3948|NCT02696317|E3|Reported Event|ACUVUE OASYS 1-DAY|All subjects exposed to ACUVUE OASYS 1-DAY contact lenses
3949|NCT02696317|E2|Reported Event|Habitual Lenses|All subjects exposed to habitual contact lenses during Period 1
3950|NCT02696317|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to initiation of study treatment
4026|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4187|NCT02690727|O1|Outcome|RP6530 in Fast Condition|"A single dose of RP6530 following fast condition
RP6530: Single oral dose"
3951|NCT02694718|B1|Baseline|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
3952|NCT02694718|P1|Participant Flow|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 milligrams per square meter (mg/m^2) on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
3953|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
4319|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
3954|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
3955|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
3956|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
3957|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
3958|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
3959|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
3960|NCT02694718|E1|Reported Event|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
3961|NCT02694536|B1|Baseline|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
3962|NCT02694536|P1|Participant Flow|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 milligrams (mg) orally (PO) once daily. Gemcitabine was administered as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
3963|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
4027|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
3964|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
3965|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
3966|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
4037|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
3967|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
3968|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
3969|NCT02694536|E1|Reported Event|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
3970|NCT02694315|B1|Baseline|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.
Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination
cervical length: measuring cervical length by trans-vaginal ultrasound"
3971|NCT02694315|P1|Participant Flow|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.
Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination
cervical length: measuring cervical length by trans-vaginal ultrasound"
3972|NCT02694315|O1|Outcome|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.
Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination
cervical length: measuring cervical length by trans-vaginal ultrasound"
3973|NCT02694315|O1|Outcome|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.
Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination
cervical length: measuring cervical length by trans-vaginal ultrasound"
3974|NCT02694315|E1|Reported Event|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.
Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination
cervical length: measuring cervical length by trans-vaginal ultrasound"
3975|NCT02694198|B1|Baseline|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
3976|NCT02694198|P1|Participant Flow|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
3977|NCT02694198|O1|Outcome|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
3978|NCT02694198|O1|Outcome|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
3979|NCT02694198|E1|Reported Event|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
3980|NCT02693704|B5|Baseline|Total|Total of all reporting groups
4188|NCT02690727|E2|Reported Event|RP6530 in Fed Condition|"A single dose of RP6530 following fed condition
RP6530: Single oral dose"
3981|NCT02693704|B4|Baseline|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3982|NCT02693704|B3|Baseline|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3983|NCT02693704|B2|Baseline|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3984|NCT02693704|B1|Baseline|Normal Hearing|People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.
3985|NCT02693704|P4|Participant Flow|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3986|NCT02693704|P3|Participant Flow|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3987|NCT02693704|P2|Participant Flow|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3988|NCT02693704|P1|Participant Flow|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.
Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
3989|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3990|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
4028|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4029|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4030|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4189|NCT02690727|E1|Reported Event|RP6530 in Fast Condition|"A single dose of RP6530 following fast condition
RP6530: Single oral dose"
3991|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3992|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.
Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
3993|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3994|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3995|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3996|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.
Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
3997|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3998|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
3999|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
4000|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.
Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
4031|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4190|NCT02689804|B3|Baseline|Total|Total of all reporting groups
4001|NCT02693704|E4|Reported Event|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
4038|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4039|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4040|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4320|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
4002|NCT02693704|E3|Reported Event|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
4003|NCT02693704|E2|Reported Event|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
4004|NCT02693704|E1|Reported Event|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.
Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
4005|NCT02692859|B3|Baseline|Total|Total of all reporting groups
4006|NCT02692859|B2|Baseline|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine
Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose"
4007|NCT02692859|B1|Baseline|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine
Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose"
4008|NCT02692859|P2|Participant Flow|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine
Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
4009|NCT02692859|P1|Participant Flow|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine
Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
4010|NCT02692859|O2|Outcome|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine
Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
4011|NCT02692859|O1|Outcome|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine
Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
4012|NCT02692859|E2|Reported Event|Vaccine (Walvax Biotechnology Co., LTD.)|"Hib conjugate vaccine
Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
4013|NCT02692859|E1|Reported Event|Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)|"Hib conjugate vaccine
Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose"
4014|NCT02691507|B3|Baseline|Total|Total of all reporting groups
4015|NCT02691507|B2|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4016|NCT02691507|B1|Baseline|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4017|NCT02691507|P2|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4018|NCT02691507|P1|Participant Flow|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4019|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4020|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4021|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4022|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4023|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4024|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4025|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4291|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
4033|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4034|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4035|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4036|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4041|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4042|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4043|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4044|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4045|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4046|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4047|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4048|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4049|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4050|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4051|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4052|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4053|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4054|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4055|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4056|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4057|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4058|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4059|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4060|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4061|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4062|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4063|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4064|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4065|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4066|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4067|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4068|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4069|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4070|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4071|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4072|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4292|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
4073|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4074|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4075|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4076|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4077|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4078|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4079|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4080|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4081|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4082|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4083|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4084|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4085|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4086|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4087|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4088|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4089|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4090|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4091|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4092|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4093|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4094|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4095|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4096|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4097|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4098|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4099|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4100|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4101|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4102|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4103|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4104|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4105|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4106|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4107|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4108|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4109|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4110|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4111|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4112|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4293|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
4113|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4114|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4115|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4116|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4117|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4118|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4119|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4120|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4121|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4122|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4123|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4124|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4125|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4126|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4127|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4128|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4129|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4130|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4131|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4132|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4133|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4134|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4135|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4136|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4137|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4138|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4139|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4140|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4141|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4142|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4143|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4144|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4145|NCT02691507|E2|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
4146|NCT02691507|E1|Reported Event|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
4147|NCT02691416|B3|Baseline|Total|Total of all reporting groups
4148|NCT02691416|B2|Baseline|Sevoflurane|"0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
4149|NCT02691416|B1|Baseline|Propofol Postconditioning|1.2ug/ml propofol Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
4150|NCT02691416|P2|Participant Flow|Sevoflurane|"0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
4151|NCT02691416|P1|Participant Flow|Propofol Postconditioning|Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
4152|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
4294|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
8029|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
4153|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol
propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
4154|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
4155|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal"
4156|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
4157|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol
propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
4158|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
4250|NCT02684942|O2|Outcome|Fentanyl|Analyze in fentanyl group.
4251|NCT02684942|O1|Outcome|Meperidine|Analyze in meperidine group.
4159|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
4160|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
4161|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
4162|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
4163|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
4164|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
4165|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
4166|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
4167|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
4168|NCT02691416|E2|Reported Event|Sevoflurane|"0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
4169|NCT02691416|E1|Reported Event|Propofol Postconditioning|"1.2ug/mL propofol
propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
4170|NCT02691143|B3|Baseline|Total|Total of all reporting groups
4171|NCT02691143|B2|Baseline|Manipulation Only|The control group received manipulation from a licensed chiropractor only
4172|NCT02691143|B1|Baseline|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
4173|NCT02691143|P2|Participant Flow|Manipulation Only|The control group received manipulation from a licensed chiropractor only
4174|NCT02691143|P1|Participant Flow|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
4175|NCT02691143|O2|Outcome|Manipulation Only|The control group received manipulation from a licensed chiropractor only
4176|NCT02691143|O1|Outcome|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
4177|NCT02691143|O2|Outcome|Manipulation Only|The control group received manipulation from a licensed chiropractor only
4178|NCT02691143|O1|Outcome|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
4179|NCT02691143|E2|Reported Event|Manipulation Only|The control group received manipulation from a licensed chiropractor only
4180|NCT02691143|E1|Reported Event|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
4181|NCT02690727|B1|Baseline|RP6530 in Fasting and Fed Conditions|"A single dose of RP6530 following fasting and Fed condition
RP6530: Single oral dose"
4182|NCT02690727|P2|Participant Flow|RP6530 in Fed Condition|"Fed Condition first, then Fast Condition...
RP6530: Single oral dose"
4183|NCT02690727|P1|Participant Flow|RP6530 in Fast Condition|"Fast Condition first, then Fed Condition
RP6530: Single oral dose"
4184|NCT02690727|O2|Outcome|RP6530 in Fed Condition|"A single dose of RP6530 following fed condition
RP6530: Single oral dose"
4185|NCT02690727|O1|Outcome|RP6530 in Fast Condition|"A single dose of RP6530 following fast condition
RP6530: Single oral dose"
4191|NCT02689804|B2|Baseline|Obese-BMI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs (LNG-EC and UPA-EC will be given in random order).
4192|NCT02689804|B1|Baseline|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs (LNG-EC and UPA-EC will be given in random order).
4193|NCT02689804|P2|Participant Flow|Obese-MRI|Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
4252|NCT02684942|O2|Outcome|Fentanyl|Separate analyze in fraction that patient received fentanyl.
4253|NCT02684942|O1|Outcome|Meperidine|Separate analyze in fraction that patient receive meperidine.
4194|NCT02689804|P1|Participant Flow|Normal-BMI|Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
4195|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4196|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4197|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4198|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4199|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4200|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4201|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4202|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4203|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4204|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4205|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4206|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4207|NCT02689804|O2|Outcome|Obese-MRI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4208|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4209|NCT02689804|O2|Outcome|Obese-BMI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4210|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4211|NCT02689804|O2|Outcome|Obese-BMI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4212|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4213|NCT02689804|O2|Outcome|Obese-BMI|Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4295|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
4214|NCT02689804|O1|Outcome|Normal-BMI|Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.
4215|NCT02689804|E4|Reported Event|Obese-BMI on UPA|Women with obese BMI will receive UPA-EC
4216|NCT02689804|E3|Reported Event|Obese-BMI on LNG|Women with obese BMI will receive LNG-EC
4217|NCT02689804|E2|Reported Event|Normal-BMI on UPA|Women with obese BMI will receive UPA-EC
4218|NCT02689804|E1|Reported Event|Normal-BMI on LNG|Women with normal BMI will receive LNG-EC
4219|NCT02687217|B3|Baseline|Total|Total of all reporting groups
4254|NCT02684942|O2|Outcome|Fentanyl|Separate analysis in fentanyl group.
4255|NCT02684942|O1|Outcome|Meperidine|Separate analysis in meperidine group.
4220|NCT02687217|B2|Baseline|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.
oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
4221|NCT02687217|B1|Baseline|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
4222|NCT02687217|P2|Participant Flow|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.
oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
4223|NCT02687217|P1|Participant Flow|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
4224|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.
oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
4225|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
4226|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.
oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
4227|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
4228|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.
oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
4229|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
4230|NCT02687217|E2|Reported Event|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.
oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
4231|NCT02687217|E1|Reported Event|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
4232|NCT02687126|B1|Baseline|Demographic Variables|gender, age, weight, height, cross sectional area, body surface area
4233|NCT02687126|P1|Participant Flow|Ultrasound Guided Central Venous Catheterization|Six month study of ultrasound guided internal jugular venous catheterization in pediatric cardiac surgical patients
4234|NCT02687126|O1|Outcome|Correlation|Correlation of cross sectional area of internal jugular vein with number of attempts, time taken for successful cannulation and complication rate
4235|NCT02687126|O1|Outcome|Number of Complications|Complications were defined as arterial puncture, hemothorax, pneumothorax and local site hematoma
4236|NCT02687126|O1|Outcome|Time to Successful Cannulation|Time taken in seconds from skin prick to aspiration of blood from catheter
4237|NCT02687126|O1|Outcome|Number of Attempts|An attempt is considered unsuccessful if complete withdrawal of the puncture needle out of skin occurs
4238|NCT02687126|E1|Reported Event|Number of Complications|Complications were defined as arterial puncture, hemothorax, pneumothorax and local site hematoma
4239|NCT02684942|B1|Baseline|All Participants|All participants who enrolled to this study.
4240|NCT02684942|P6|Participant Flow|Fentanyl,Meperidine,Meperidine,Fentanyl|"First and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Second and Third Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
4241|NCT02684942|P5|Participant Flow|Meperidine,Fentanyl,Fentanyl,Meperidine|"First and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Second and Third Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
4242|NCT02684942|P4|Participant Flow|Fentanyl,Fentanyl,Meperidine,Meperidine|"First and Second Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Third and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
4243|NCT02684942|P3|Participant Flow|Meperidine,Meperidine,Fentanyl,Fentanyl|"First and Second Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Third and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
4244|NCT02684942|P2|Participant Flow|Fentanyl,Meperidine,Fentanyl,Meperidine|"First and Third Intervention inject inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Second and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
8030|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
4245|NCT02684942|P1|Participant Flow|Meperidine,Fentanyl,Meperidine,Fentanyl|"First and Third Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Second and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
4246|NCT02684942|O1|Outcome|Fentanyl|Analyze in fentanyl group.
4247|NCT02684942|O1|Outcome|Meperidine|Analyze in meperidine group.
4248|NCT02684942|O2|Outcome|Fentanyl|Separate analyze in fraction that patient received fentanyl.
4249|NCT02684942|O1|Outcome|Meperidine|Separate analyze in fraction that patient receive meperidine.
4259|NCT02684630|B2|Baseline|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.
Trima Accel System: Platelet Apheresis Procedure"
4260|NCT02684630|B1|Baseline|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.
Trima Accel System: Platelet Apheresis Procedure"
4261|NCT02684630|P2|Participant Flow|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.
Trima Accel System: Platelet Apheresis Procedure"
4262|NCT02684630|P1|Participant Flow|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.
Trima Accel System: Platelet Apheresis Procedure"
4263|NCT02684630|O2|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.
Trima Accel System: Platelet Apheresis Procedure"
4264|NCT02684630|O1|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.
Trima Accel System: Platelet Apheresis Procedure"
4265|NCT02684630|O2|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).
Trima Accel System: Platelet Apheresis Procedure"
4266|NCT02684630|O1|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).
Trima Accel System: Platelet Apheresis Procedure"
4267|NCT02684630|E2|Reported Event|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).
Trima Accel System: Platelet Apheresis Procedure"
4268|NCT02684630|E1|Reported Event|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).
Trima Accel System: Platelet Apheresis Procedure"
4269|NCT02684604|B3|Baseline|Total|Total of all reporting groups
4270|NCT02684604|B2|Baseline|Fertile Women|44 fertile women
4271|NCT02684604|B1|Baseline|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
4272|NCT02684604|P2|Participant Flow|Fertile Women|44 fertile women
4273|NCT02684604|P1|Participant Flow|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
4274|NCT02684604|O2|Outcome|Fertile Women|44 fertile women
4275|NCT02684604|O1|Outcome|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
4276|NCT02684604|E2|Reported Event|Fertile Women|44 fertile women
4277|NCT02684604|E1|Reported Event|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
4278|NCT02684396|B7|Baseline|Total|Total of all reporting groups
4279|NCT02684396|B6|Baseline|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
4280|NCT02684396|B5|Baseline|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
4281|NCT02684396|B4|Baseline|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
4282|NCT02684396|B3|Baseline|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
4283|NCT02684396|B2|Baseline|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
4284|NCT02684396|B1|Baseline|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
4285|NCT02684396|P6|Participant Flow|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
4286|NCT02684396|P5|Participant Flow|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
4287|NCT02684396|P4|Participant Flow|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
4288|NCT02684396|P3|Participant Flow|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
4289|NCT02684396|P2|Participant Flow|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
4290|NCT02684396|P1|Participant Flow|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
4299|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
4300|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
4301|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
4302|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
4303|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
4304|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
4305|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
4306|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
4307|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
4308|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
4309|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
4310|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
4311|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
4312|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
6641|NCT02596451|B4|Baseline|Total|Total of all reporting groups
4323|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
4324|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
4325|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
4326|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
4327|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
4328|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
4329|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
4330|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
4331|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
4332|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
4333|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
4334|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
4335|NCT02684396|E6|Reported Event|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
4336|NCT02684396|E5|Reported Event|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
4337|NCT02684396|E4|Reported Event|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
4338|NCT02684396|E3|Reported Event|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
4339|NCT02684396|E2|Reported Event|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
4340|NCT02684396|E1|Reported Event|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
4341|NCT02683954|B3|Baseline|Total|Total of all reporting groups
4342|NCT02683954|B2|Baseline|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
4343|NCT02683954|B1|Baseline|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
4344|NCT02683954|P2|Participant Flow|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
4345|NCT02683954|P1|Participant Flow|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
4346|NCT02683954|O2|Outcome|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
4347|NCT02683954|O1|Outcome|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
4348|NCT02683954|E2|Reported Event|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
4584|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
4349|NCT02683954|E1|Reported Event|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
4350|NCT02682498|B3|Baseline|Total|Total of all reporting groups
4351|NCT02682498|B2|Baseline|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
4352|NCT02682498|B1|Baseline|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
4353|NCT02682498|P2|Participant Flow|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
4354|NCT02682498|P1|Participant Flow|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
4355|NCT02682498|O2|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
4509|NCT02670473|O1|Outcome|Habitual Lenses|enfilcon A habitual lens (control)
4510|NCT02670473|O4|Outcome|Completely Dissatisfied|
4356|NCT02682498|O1|Outcome|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
4357|NCT02682498|O2|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.
4358|NCT02682498|O1|Outcome|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
4359|NCT02682498|O2|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
4360|NCT02682498|O1|Outcome|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
4361|NCT02682498|O2|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
4362|NCT02682498|O1|Outcome|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
4363|NCT02682498|O2|Outcome|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
4397|NCT02678923|O1|Outcome|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
4398|NCT02678923|O2|Outcome|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
4399|NCT02678923|O1|Outcome|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
4585|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
4364|NCT02682498|O1|Outcome|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
4365|NCT02682498|E2|Reported Event|Standard Periarticular Joint Injection|A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
4366|NCT02682498|E1|Reported Event|EXPAREL® Bupivacaine Liposome Suspension|"Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery."
4367|NCT02681458|B3|Baseline|Total|Total of all reporting groups
4368|NCT02681458|B2|Baseline|Non-drug Users|"Control group that consisted of non drug users with fungal infections
Direct Examination: It was an observational study and subjects received their routine treatment."
4369|NCT02681458|B1|Baseline|Drug Users|"Case group that consisted of drug users with fungal infections
Direct Examination: It was an observational study and subjects received their routine treatment."
4370|NCT02681458|P2|Participant Flow|Non-drug Users|"Control group that consisted of non-drug users with fungal infections
Direct Examination: It was an observational study and subjects received their routine treatment."
4371|NCT02681458|P1|Participant Flow|Drug Users|"Case group that consisted of drug users with fungal infections
Direct Examination: It was an observational study and subjects received their routine treatment."
4372|NCT02681458|O2|Outcome|Non-drug Users|"Control group that consisted of non-drug users with fungal infections
Direct Examination: It was an observational study and subjects received their routine treatment."
4373|NCT02681458|O1|Outcome|Drug Users|"Case group that consisted of drug users with fungal infections
Direct Examination: It was an observational study and subjects received their routine treatment."
4374|NCT02681458|E2|Reported Event|Non-drug Users|"Control group that consisted of non-drug users with fungal infections
Direct Examination: It was an observational study and subjects received their routine treatment."
4375|NCT02681458|E1|Reported Event|Drug Users|"Case group that consisted of drug users with fungal infections
Direct Examination: It was an observational study and subjects received their routine treatment."
4376|NCT02679976|B1|Baseline|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
4377|NCT02679976|P1|Participant Flow|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
4378|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
4379|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
4380|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
4381|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
4382|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
4383|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
4384|NCT02679976|E1|Reported Event|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
4385|NCT02679469|B1|Baseline|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet
nalmefene hydrochloride 10 mg"
4386|NCT02679469|P1|Participant Flow|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet
nalmefene hydrochloride 10 mg"
4387|NCT02679469|O1|Outcome|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet
nalmefene hydrochloride 10 mg"
4388|NCT02679469|O1|Outcome|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet
nalmefene hydrochloride 10 mg"
4389|NCT02679469|O1|Outcome|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet
nalmefene hydrochloride 10 mg"
4390|NCT02679469|E1|Reported Event|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet
nalmefene hydrochloride 10 mg"
4391|NCT02678923|B3|Baseline|Total|Total of all reporting groups
4392|NCT02678923|B2|Baseline|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
4393|NCT02678923|B1|Baseline|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
4394|NCT02678923|P2|Participant Flow|Placebo|360 mL of placebo (0.9% sodium chloride [NaCl] solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
4395|NCT02678923|P1|Participant Flow|MDCO-216|20 milligrams/kilogram (mg/kg) of MDCO-216 administered intravenously (IV) as a 360 milliliter (mL) infusion over 2 hours on Days 1, 8, 15, 22, and 29
4396|NCT02678923|O2|Outcome|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
4586|NCT02666560|O2|Outcome|AC20|Auditory cueing set at 20% above self paced cadence
4400|NCT02678923|O2|Outcome|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
4401|NCT02678923|O1|Outcome|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
4402|NCT02678923|O2|Outcome|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
4403|NCT02678923|O1|Outcome|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
4404|NCT02678923|O2|Outcome|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
4405|NCT02678923|O1|Outcome|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
4406|NCT02678923|E2|Reported Event|Placebo|360 mL of placebo (0.9% NaCl solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
4407|NCT02678923|E1|Reported Event|MDCO-216|20 mg/kg of MDCO-216 administered IV as a 360 mL infusion over 2 hours on Days 1, 8, 15, 22, and 29
4408|NCT02678676|B3|Baseline|Total|Total of all reporting groups
4409|NCT02678676|B2|Baseline|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
4410|NCT02678676|B1|Baseline|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
4411|NCT02678676|P2|Participant Flow|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
4412|NCT02678676|P1|Participant Flow|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
4413|NCT02678676|O2|Outcome|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
4449|NCT02677493|E3|Reported Event|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
4414|NCT02678676|O1|Outcome|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
4415|NCT02678676|O2|Outcome|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
4416|NCT02678676|O1|Outcome|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
4417|NCT02678676|E2|Reported Event|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
4418|NCT02678676|E1|Reported Event|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
4419|NCT02677779|B3|Baseline|Total|Total of all reporting groups
4420|NCT02677779|B2|Baseline|Traditional Surgery|"Ulcer debridement with traditional surgery
traditional surgery: Single session of traditional debridement"
4421|NCT02677779|B1|Baseline|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)
CO2 laser: Single session of CO2 laser debridement"
4422|NCT02677779|P2|Participant Flow|Traditional Surgery|"Ulcer debridement with traditional surgery
traditional surgery: Single session of traditional debridement"
4423|NCT02677779|P1|Participant Flow|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)
CO2 laser: Single session of CO2 laser debridement"
4424|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery
traditional surgery: Single session of traditional debridement"
4425|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)
CO2 laser: Single session of CO2 laser debridement"
4426|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery
traditional surgery: Single session of traditional debridement"
4427|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)
CO2 laser: Single session of CO2 laser debridement"
4428|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery
traditional surgery: Single session of traditional debridement"
4429|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)
CO2 laser: Single session of CO2 laser debridement"
4430|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery
traditional surgery: Single session of traditional debridement"
4431|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)
CO2 laser: Single session of CO2 laser debridement"
4432|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery
traditional surgery: Single session of traditional debridement"
4433|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)
CO2 laser: Single session of CO2 laser debridement"
4434|NCT02677779|E2|Reported Event|Traditional Surgery|"Ulcer debridement with traditional surgery
traditional surgery: Single session of traditional debridement"
4435|NCT02677779|E1|Reported Event|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)
CO2 laser: Single session of CO2 laser debridement"
4436|NCT02677493|B4|Baseline|Total|Total of all reporting groups
4437|NCT02677493|B3|Baseline|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
4438|NCT02677493|B2|Baseline|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
4587|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
4439|NCT02677493|B1|Baseline|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
4440|NCT02677493|P3|Participant Flow|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
4441|NCT02677493|P2|Participant Flow|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
4442|NCT02677493|P1|Participant Flow|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
4443|NCT02677493|O3|Outcome|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
4444|NCT02677493|O2|Outcome|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
4445|NCT02677493|O1|Outcome|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
4446|NCT02677493|O3|Outcome|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
4447|NCT02677493|O2|Outcome|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
4448|NCT02677493|O1|Outcome|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
4498|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
4450|NCT02677493|E2|Reported Event|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
4451|NCT02677493|E1|Reported Event|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
4452|NCT02675543|B3|Baseline|Total|Total of all reporting groups
4453|NCT02675543|B2|Baseline|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
Vitreous Tamponade with Silicone Oil"
4454|NCT02675543|B1|Baseline|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)
Vitreous Tamponade with Silicone Oil"
4455|NCT02675543|P2|Participant Flow|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
Vitreous Tamponade with Silicone Oil"
4456|NCT02675543|P1|Participant Flow|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)
Vitreous Tamponade with Silicone Oil"
4457|NCT02675543|O2|Outcome|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
Vitreous Tamponade with Silicone Oil"
4458|NCT02675543|O1|Outcome|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)
Vitreous Tamponade with Silicone Oil"
4459|NCT02675543|E2|Reported Event|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
Vitreous Tamponade with Silicone Oil"
4460|NCT02675543|E1|Reported Event|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)
Vitreous Tamponade with Silicone Oil"
4461|NCT02673944|B1|Baseline|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter
Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
4462|NCT02673944|P1|Participant Flow|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter
Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
4463|NCT02673944|O2|Outcome|Standard Urodynamic Analyzer|Patients will undergo a routine urodynamic evaluation, which will collect both Peritorn+ and UDS data.
4464|NCT02673944|O1|Outcome|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter
Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
4465|NCT02673944|E1|Reported Event|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter
Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
4466|NCT02672514|B3|Baseline|Total|Total of all reporting groups
4467|NCT02672514|B2|Baseline|Group A|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.
Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
4483|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
4468|NCT02672514|B1|Baseline|Group B|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.
Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
4469|NCT02672514|P2|Participant Flow|CECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.
Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
4470|NCT02672514|P1|Participant Flow|MiECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.
Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
4499|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
4500|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
4471|NCT02672514|O2|Outcome|Group A|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.
Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
4472|NCT02672514|O1|Outcome|Group B|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.
Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
4473|NCT02672514|E2|Reported Event|CECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.
Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
4474|NCT02672514|E1|Reported Event|MiECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.
Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
4475|NCT02670811|B3|Baseline|Total|Total of all reporting groups
4476|NCT02670811|B2|Baseline|Placebo|"Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk"
4477|NCT02670811|B1|Baseline|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
4478|NCT02670811|P2|Participant Flow|Placebo|"Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk"
4479|NCT02670811|P1|Participant Flow|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
4480|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk"
4481|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
4482|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk"
8031|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
4484|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk"
4485|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
4486|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk"
4487|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
4488|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk"
4489|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
4490|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk"
4491|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
4492|NCT02670811|E2|Reported Event|Placebo|"Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk"
4493|NCT02670811|E1|Reported Event|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
4494|NCT02670473|B1|Baseline|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
fanfilcon A (test): contact lens"
4495|NCT02670473|P1|Participant Flow|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
fanfilcon A (test): contact lens"
4496|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
4497|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
4517|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
4518|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
4519|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
4520|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
4521|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
4522|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
4523|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
4524|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
4525|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
4526|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
4527|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
4528|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
4529|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
4530|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
4531|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
4532|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
4533|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
4534|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
4535|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
4536|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
4537|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
4538|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
4539|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
4540|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
4541|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
4542|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
4543|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
4544|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
4545|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
4546|NCT02670473|E1|Reported Event|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
fanfilcon A (test): contact lens"
4547|NCT02669095|B3|Baseline|Total|Total of all reporting groups
4548|NCT02669095|B2|Baseline|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
4549|NCT02669095|B1|Baseline|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
4550|NCT02669095|P2|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
4551|NCT02669095|P1|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
4552|NCT02669095|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
4553|NCT02669095|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
4554|NCT02669095|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
4555|NCT02669095|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
4556|NCT02669095|E2|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
4557|NCT02669095|E1|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
4558|NCT02669043|B1|Baseline|Ketamine|"All participants receive open-label ketamine
Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
4559|NCT02669043|P1|Participant Flow|Ketamine|"All participants receive open-label ketamine
Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
4560|NCT02669043|O1|Outcome|Ketamine|"All participants receive open-label ketamine
Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
4561|NCT02669043|E1|Reported Event|Ketamine|"All participants receive open-label ketamine
Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
4562|NCT02667704|B1|Baseline|Nintedanib (Reference (R)) / Bosentan+Nintedanib (Test (T))|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 and then multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 of period 2 administered orally with 240 millilitre (mL) of water
4563|NCT02667704|P1|Participant Flow|Nintedanib (Reference (R)) / Bosentan+Nintedanib (Test (T))|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 and then multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 of period 2 administered orally with 240 millilitre (mL) of water
4564|NCT02667704|O2|Outcome|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
4565|NCT02667704|O1|Outcome|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 administered orally with 240 millilitre (mL) of water.
4566|NCT02667704|O2|Outcome|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
4567|NCT02667704|O1|Outcome|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 administered orally with 240 millilitre (mL) of water.
4618|NCT02665260|E1|Reported Event|Cantharidin|Subjects treated with topical cantharidin 0.7% without occlusion
7953|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
4568|NCT02667704|O2|Outcome|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
4569|NCT02667704|O1|Outcome|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 administered orally with 240 millilitre (mL) of water.
4570|NCT02667704|E3|Reported Event|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 7 and 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
4571|NCT02667704|E2|Reported Event|Bosentan|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 6 of period 2 administered orally with 240 mL of water
4572|NCT02667704|E1|Reported Event|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 administered orally with 240 millilitre (mL) of water.
4573|NCT02666560|B1|Baseline|All Study Participants|"Participants performed a functional task with auditory cueing set at self paced cadence and 20% above self paced cadence.
Auditory Cueing: This was delivered by a metronome producing a beat which was set at the participant's baseline cadence or 20% above baseline cadence.
This was a crossover design where participants completed both arms in the trial."
4574|NCT02666560|P2|Participant Flow|Cueing at 20% Above Self Paced Cadence Then Self Based Cadence|"Participants performed a functional task with auditory cueing set at 20% above self paced cadence. Five days following participants performed a functional task with auditory cueing set at self paced cadence.
Auditory Cueing: This was delivered by a metronome, which was set at a beat frequency rate 20% above baseline cadence or that matched the participant's baseline cadence."
4575|NCT02666560|P1|Participant Flow|Cueing Self Paced Then Cueing 20% Above Self Paced Cadence|"Participants performed a functional task with auditory cueing set at self paced cadence. Five days following participants performed a functional task with auditory cueing set at 20% above self paced cadence.
Auditory Cueing: This was was delivered by a metronome, which was set at a beat frequency rate that matched the participant's baseline cadence or 20% above baseline cadence."
4576|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
4577|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
4578|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
4579|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
4580|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
4581|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
4582|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
4583|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
4588|NCT02666560|E2|Reported Event|Cueing at 20% Above Self Paced Cadence|"Participants performed a functional task with auditory cueing set at 20% above self paced cadence whilst performing a functional task.
Auditory Cueing: Auditory cueing set at different frequency rates"
4589|NCT02666560|E1|Reported Event|Auditory Cueing at Self Paced Cadence|"Participants performed a functional task with auditory cueing set at self paced cadence.
Auditory Cueing: Auditory cueing set at different frequency rates"
4590|NCT02666222|B1|Baseline|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
4591|NCT02666222|P1|Participant Flow|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
4592|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
4593|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
4594|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
4595|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
4596|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
4597|NCT02666222|E1|Reported Event|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
4598|NCT02665260|B5|Baseline|Total|Total of all reporting groups
4599|NCT02665260|B4|Baseline|Placebo With Occlusion|Patients treated with placebo vehicle with occlusion
4600|NCT02665260|B3|Baseline|Placebo|Patients treated with placebo without occlusion
4601|NCT02665260|B2|Baseline|Cantharidin With Occlusion|Patients treated with 0.7% topical cantharidin with occlusion
4602|NCT02665260|B1|Baseline|Cantharidin|Patients treated with 0.7% topical cantharidin without occlusion
4603|NCT02665260|P4|Participant Flow|Placebo Without Occlusion|Patients treated with placebo without conclusion
4604|NCT02665260|P3|Participant Flow|Placebo With Occlusion|Patients treated with placebo and occlusion
4605|NCT02665260|P2|Participant Flow|Cantharidin Without Occlusion|Patients treated with cantharidin 0.7% topical without occlusion
4606|NCT02665260|P1|Participant Flow|Cantharidin With Occlusion|Patients treated with cantharidin 0.7% topical with occlusion
4607|NCT02665260|O4|Outcome|Placebo With Occlusion|Patients treated with placebo vehicle with occlusion
4608|NCT02665260|O3|Outcome|Placebo|Patients treated with placebo without occlusion
4609|NCT02665260|O2|Outcome|Cantharidin With Occlusion|Patients treated with 0.7% topical cantharidin with occlusion
4610|NCT02665260|O1|Outcome|Cantharidin|Patients treated with 0.7% topical cantharidin without occlusion
4611|NCT02665260|O4|Outcome|Placebo Without Occlusion|Patients treated with placebo without conclusion
4612|NCT02665260|O3|Outcome|Placebo With Occlusion|Patients treated with placebo and occlusion
4613|NCT02665260|O2|Outcome|Cantharidin Without Occlusion|Patients treated with cantharidin 0.7% topical without occlusion
4614|NCT02665260|O1|Outcome|Cantharidin With Occlusion|Patients treated with cantharidin 0.7% topical with occlusion
4615|NCT02665260|E4|Reported Event|Placebo With Occlusion|Subjects treated with placebo with occlusion
4616|NCT02665260|E3|Reported Event|Placebo|Subjects treated with placebo without occlusion
4617|NCT02665260|E2|Reported Event|Cantharidin With Occlusion|Subjects treated with topical cantharidin 0.7% with occlusion
4619|NCT02664987|B1|Baseline|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
4620|NCT02664987|P1|Participant Flow|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
4621|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
4622|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
4623|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
4624|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
4625|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
4626|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
4627|NCT02664987|E1|Reported Event|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
4628|NCT02664610|B3|Baseline|Total|Total of all reporting groups
4629|NCT02664610|B2|Baseline|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.
Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
4630|NCT02664610|B1|Baseline|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
4631|NCT02664610|P2|Participant Flow|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.
Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
4632|NCT02664610|P1|Participant Flow|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
4633|NCT02664610|O2|Outcome|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.
Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
4634|NCT02664610|O1|Outcome|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
4635|NCT02664610|O2|Outcome|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.
Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
4636|NCT02664610|O1|Outcome|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
8032|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
4637|NCT02664610|E2|Reported Event|Text Messages, Hypertensive|"Participants who have high blood pressure, who are randomized to receive text messages.
Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages"
4638|NCT02664610|E1|Reported Event|No Text Messages, Hypertensive|Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
4639|NCT02664532|B3|Baseline|Total|Total of all reporting groups
4640|NCT02664532|B2|Baseline|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Macintosh group: Macintosh blade was used for laryngoscopy"
4641|NCT02664532|B1|Baseline|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Miller group: Miller blade was used for laryngoscopy"
4642|NCT02664532|P2|Participant Flow|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Macintosh group: Macintosh blade was used for laryngoscopy"
4643|NCT02664532|P1|Participant Flow|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Miller group: Miller blade was used for laryngoscopy"
4644|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Macintosh group: Macintosh blade was used for laryngoscopy"
4645|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Miller group: Miller blade was used for laryngoscopy"
4646|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Macintosh group: Macintosh blade was used for laryngoscopy"
4647|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Miller group: Miller blade was used for laryngoscopy"
4648|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Macintosh group: Macintosh blade was used for laryngoscopy"
4649|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Miller group: Miller blade was used for laryngoscopy"
4650|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Macintosh group: Macintosh blade was used for laryngoscopy"
4651|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Miller group: Miller blade was used for laryngoscopy"
4652|NCT02664532|E2|Reported Event|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Macintosh group: Macintosh blade was used for laryngoscopy"
4653|NCT02664532|E1|Reported Event|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
Miller group: Miller blade was used for laryngoscopy"
4654|NCT02664311|B3|Baseline|Total|Total of all reporting groups
4655|NCT02664311|B2|Baseline|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
4656|NCT02664311|B1|Baseline|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study
Conventional ventilation: Conventional ventilator - control arm"
4657|NCT02664311|P2|Participant Flow|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
4658|NCT02664311|P1|Participant Flow|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study
Conventional ventilation: Conventional ventilator - control arm"
4659|NCT02664311|O2|Outcome|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
4660|NCT02664311|O1|Outcome|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study
Conventional ventilation: Conventional ventilator - control arm"
4661|NCT02664311|O2|Outcome|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
4662|NCT02664311|O1|Outcome|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study
Conventional ventilation: Conventional ventilator - control arm"
4663|NCT02664311|O2|Outcome|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
4664|NCT02664311|O1|Outcome|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study
Conventional ventilation: Conventional ventilator - control arm"
4665|NCT02664311|E2|Reported Event|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
4666|NCT02664311|E1|Reported Event|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study
Conventional ventilation: Conventional ventilator - control arm"
4667|NCT02663453|B3|Baseline|Total|Total of all reporting groups
4668|NCT02663453|B2|Baseline|Control Group|"pure soybean oil lipid emulsion(intralipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
pure soybean oil lipid emulsion: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached."
4669|NCT02663453|B1|Baseline|Study Group|"multicomponent lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
multicomponent lipid emulsion: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached."
4715|NCT02662608|O1|Outcome|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
4716|NCT02662608|E1|Reported Event|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
4849|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4670|NCT02663453|P2|Participant Flow|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
4671|NCT02663453|P1|Participant Flow|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
4672|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
4673|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
4674|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
5168|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
8033|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
4675|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
4676|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
4677|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
4678|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
4679|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
4717|NCT02662556|B1|Baseline|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg
Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
4680|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
4681|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
4682|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
4683|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
4684|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
4700|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4701|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4685|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
4686|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
4687|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
4688|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
4689|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
4690|NCT02663453|E2|Reported Event|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
4691|NCT02663453|E1|Reported Event|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
4692|NCT02663232|B1|Baseline|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4693|NCT02663232|P1|Participant Flow|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4694|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4695|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4696|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4697|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4698|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4699|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
5169|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
4702|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4703|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4704|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4705|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4706|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4707|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4708|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4709|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4710|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4711|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4712|NCT02663232|E1|Reported Event|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
4713|NCT02662608|B1|Baseline|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
4714|NCT02662608|P1|Participant Flow|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
4718|NCT02662556|P1|Participant Flow|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg
Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
4719|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg
Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
4720|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg
Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
4721|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg
Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
4722|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg
Sufentanil sublingual tablet (SST) 30 mcg: one sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
4723|NCT02662556|E1|Reported Event|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg
Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
4724|NCT02662387|B3|Baseline|Total|Total of all reporting groups
4725|NCT02662387|B2|Baseline|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator
External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 28"
4726|NCT02662387|B1|Baseline|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 27"
4727|NCT02662387|P2|Participant Flow|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator
External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 28"
4728|NCT02662387|P1|Participant Flow|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 27"
4729|NCT02662387|O2|Outcome|HFNC With END|High flow nasal cannula with external nasal dilator
4730|NCT02662387|O1|Outcome|HFNC Group|High flow nasal cannula alone without external nasal dilator
5170|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
4731|NCT02662387|O2|Outcome|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator
External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Lower MBSS"
4732|NCT02662387|O1|Outcome|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Higher MBSS"
4733|NCT02662387|E2|Reported Event|HFNC and External Nasal Dilator (END)|"high flow nasal cannula and external nasal dilator
External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation No adverse events"
4734|NCT02662387|E1|Reported Event|High Flow Nasal Cannula (HFNC)|"Non-invasive positive pressure ventilation
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation No adverse events"
4735|NCT02658461|B4|Baseline|Total|Total of all reporting groups
4736|NCT02658461|B3|Baseline|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4737|NCT02658461|B2|Baseline|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4738|NCT02658461|B1|Baseline|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4739|NCT02658461|P3|Participant Flow|Trastuzumab Intravenous (IV) Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed greater than (>) 1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4740|NCT02658461|P2|Participant Flow|Trastuzumab Subcutaneous (SC) Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4741|NCT02658461|P1|Participant Flow|Trastuzumab Single-Use Injection Device|Participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) received trastuzumab via single-use injection device as 600 milligrams (mg) on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4742|NCT02658461|O3|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4844|NCT02651922|P1|Participant Flow|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4845|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4743|NCT02658461|O2|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4744|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4745|NCT02658461|O3|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4746|NCT02658461|O2|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4747|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4748|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4749|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4750|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4751|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4802|NCT02656160|P2|Participant Flow|Placebo First, 4-AP Second|Placebo-matching 4-AP administered 3 hours before normal sleep time on first study night, then a 1-week non-treatment period, then 4-AP administered 3 hours before normal sleep time on second study night.
8034|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
4752|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4753|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4754|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4755|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4756|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4757|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4758|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4759|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4760|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4761|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4846|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4762|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4763|NCT02658461|E3|Reported Event|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4764|NCT02658461|E2|Reported Event|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4765|NCT02658461|E1|Reported Event|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
4766|NCT02657629|B3|Baseline|Total|Total of all reporting groups
4767|NCT02657629|B2|Baseline|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.
Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
4768|NCT02657629|B1|Baseline|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.
Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
4769|NCT02657629|P2|Participant Flow|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.
Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
4770|NCT02657629|P1|Participant Flow|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.
Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
4771|NCT02657629|O2|Outcome|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.
Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
5415|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
4772|NCT02657629|O1|Outcome|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.
Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
4773|NCT02657629|E2|Reported Event|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.
Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
4774|NCT02657629|E1|Reported Event|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.
Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
4775|NCT02657538|B1|Baseline|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.
The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
4776|NCT02657538|P1|Participant Flow|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.
The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
4777|NCT02657538|O1|Outcome|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.
The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
4778|NCT02657538|O2|Outcome|Visual Caries Detection + BW|"visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.
Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed
Visual examination and bitewing (BW) radiography: established diagnostic methods"
4779|NCT02657538|O1|Outcome|Near Infrared Transillumination|"Near infrared transillumination is applied for initial enamel caries lesion detection.
Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed
Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)"
4780|NCT02657538|E2|Reported Event|Visual Caries Detection + BW|"visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.
Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed
Visual examination and bitewing (BW) radiography: established diagnostic methods"
4781|NCT02657538|E1|Reported Event|Near Infrared Transillumination|"Near infrared transillumination is applied for initial enamel caries lesion detection.
Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed
Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)"
4782|NCT02656485|B5|Baseline|Total|Total of all reporting groups
4783|NCT02656485|B4|Baseline|Placebo|"Placebo
Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4784|NCT02656485|B3|Baseline|Dose III|"B244 dose strength III
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4785|NCT02656485|B2|Baseline|Dose II|"B244 dose strength II
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4786|NCT02656485|B1|Baseline|Dose I|"B244 dose strength I
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4787|NCT02656485|P4|Participant Flow|Placebo|Placebo: 10 pumps of spray applied BID twice a day to the entire face for 14 days
4788|NCT02656485|P3|Participant Flow|Dose III|BB244 Dose III: 10 pumps of spray applied BID twice a day to the entire face for 14 days
4789|NCT02656485|P2|Participant Flow|Dose II|BB244 Dose II : 10 pumps of spray applied BID twice a day to the entire face for 14 days
4790|NCT02656485|P1|Participant Flow|Dose I|BB244 Dose I : 10 pumps of spray applied BID twice a day to the entire face for 14 days
4791|NCT02656485|O2|Outcome|Placebo|Placebo Arm
4792|NCT02656485|O1|Outcome|Pooled Active Doses|Pooled Active Doses (Doses I, II, III)
4793|NCT02656485|O4|Outcome|Placebo|"Placebo
Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4794|NCT02656485|O3|Outcome|Dose III|"B244 dose III
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4795|NCT02656485|O2|Outcome|Dose II|"B244 dose II
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4796|NCT02656485|O1|Outcome|Dose I|"B244 dose I
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4797|NCT02656485|E4|Reported Event|Placebo|"Placebo
Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4798|NCT02656485|E3|Reported Event|Dose III|"B244 Dose 3 (dose level [cells/mL] 80,000,000,000)
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4799|NCT02656485|E2|Reported Event|Dose II|"B244 Dose 2 (dose level [cells/mL] 40,000,000,000)
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4800|NCT02656485|E1|Reported Event|Dose I|"B244 Dose 1 (dose level [cells/mL] 20,000,000,000)
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
4801|NCT02656160|B1|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis.
5171|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
4803|NCT02656160|P1|Participant Flow|4-AP First, Placebo Second|4-AP 10 mg administered 3 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching 4-AP administered 3 hours before normal sleep time on second study night.
4804|NCT02656160|O2|Outcome|Dalfampridine|Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
4805|NCT02656160|O1|Outcome|Placebo|Placebo: Placebo 3 hrs before sleep
4806|NCT02656160|O2|Outcome|Dalfampridine|Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
4807|NCT02656160|O1|Outcome|Placebo|Placebo: Placebo 3 hrs before sleep
4808|NCT02656160|E2|Reported Event|Dalfampridine|Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
4809|NCT02656160|E1|Reported Event|Placebo|Placebo: Placebo 3 hrs before sleep
4810|NCT02653560|B1|Baseline|All Study Participants|Participants took Potassium magnesium Citrate (KMgCit), potassium citrate (KCit), potassium chloride (KCl) and placebo each for 4 weeks in a randomized crossover design.
4811|NCT02653560|P4|Participant Flow|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.
Placebo"
4812|NCT02653560|P3|Participant Flow|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks
Potassium chloride powder"
4813|NCT02653560|P2|Participant Flow|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.
Potassium citrate powder"
4814|NCT02653560|P1|Participant Flow|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks
Potassium magnesium Citrate (KMgCit)"
4815|NCT02653560|O4|Outcome|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.
Placebo"
4816|NCT02653560|O3|Outcome|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks
Potassium chloride powder"
4847|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4848|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
7954|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
4817|NCT02653560|O2|Outcome|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.
Potassium citrate powder"
4818|NCT02653560|O1|Outcome|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks
Potassium magnesium Citrate (KMgCit)"
4819|NCT02653560|E4|Reported Event|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.
Placebo"
4820|NCT02653560|E3|Reported Event|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks
Potassium chloride powder"
4821|NCT02653560|E2|Reported Event|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.
Potassium citrate powder"
4822|NCT02653560|E1|Reported Event|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks
Potassium magnesium Citrate (KMgCit)"
4823|NCT02652221|B1|Baseline|Study Cohort|"Acoustic Radiation Force Imaging
Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness."
4824|NCT02652221|P1|Participant Flow|Study Cohort|"Acoustic Radiation Force Imaging
Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness."
4825|NCT02652221|O2|Outcome|BMI >30kg/m2|Subset of study cohort with BMI 30 kg/m2 or more
4826|NCT02652221|O1|Outcome|BMI <30 kg/m2|Subset of study cohort with BMI <30 kg/m2
4827|NCT02652221|O2|Outcome|BMI >30kg/m2|Subset of study cohort with BMI 30 kg/m2 or more
4828|NCT02652221|O1|Outcome|BMI <30 kg/m2|Subset of study cohort with BMI <30 kg/m2
4829|NCT02652221|E1|Reported Event|Study Cohort|"Acoustic Radiation Force Imaging
Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness."
4830|NCT02652208|B3|Baseline|Total|Total of all reporting groups
4831|NCT02652208|B2|Baseline|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.
Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
8035|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
4832|NCT02652208|B1|Baseline|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.
Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
4833|NCT02652208|P2|Participant Flow|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.
Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
4834|NCT02652208|P1|Participant Flow|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.
Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
4835|NCT02652208|O2|Outcome|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.
Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
4836|NCT02652208|O1|Outcome|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.
Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
4837|NCT02652208|O2|Outcome|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.
Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
4838|NCT02652208|O1|Outcome|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.
Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
4839|NCT02652208|O2|Outcome|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.
Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
4840|NCT02652208|O1|Outcome|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.
Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
4841|NCT02652208|E2|Reported Event|Video Decision Aid|"This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.
Video decision aid: The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort"
4842|NCT02652208|E1|Reported Event|Online Decision Aid|"This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.
Online decision aid: The Healthwise online shared decision point for Stable Chest Discomfort"
4843|NCT02651922|B1|Baseline|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4850|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4851|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4852|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4853|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4854|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4855|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4856|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4857|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4858|NCT02651922|O1|Outcome|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4859|NCT02651922|E1|Reported Event|PASCOFLAIR Group (Verum)|Patients who were treated with PASCOFLAIR
4860|NCT02651467|B4|Baseline|Total|Total of all reporting groups
4861|NCT02651467|B3|Baseline|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4862|NCT02651467|B2|Baseline|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4863|NCT02651467|B1|Baseline|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
5016|NCT02646449|B1|Baseline|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
4864|NCT02651467|P3|Participant Flow|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4865|NCT02651467|P2|Participant Flow|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4866|NCT02651467|P1|Participant Flow|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% weight by weight [w/w] KOX, 0 parts per million [ppm], pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4867|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4868|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4869|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4970|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
4971|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
4972|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
4973|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
4870|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )(using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4871|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4872|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4873|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4874|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4875|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
5024|NCT02646449|E1|Reported Event|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
4876|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4877|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4878|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4879|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4880|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4881|NCT02651467|E3|Reported Event|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
7955|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
4882|NCT02651467|E2|Reported Event|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4883|NCT02651467|E1|Reported Event|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
4884|NCT02650219|B3|Baseline|Total|Total of all reporting groups
4885|NCT02650219|B2|Baseline|Control|"healthy subjects intervention: genetic analyses
genetic analyses"
4886|NCT02650219|B1|Baseline|Gaucher Disease Type 1|"Inclusion criteria:
Adult patients >= 18 years old
Gaucher disease type 1, proved by low betaglucosidase, with or without treatment
Patients must have read, understood and signed informed consent. intervention : genetic analyses
genetic analyses"
4887|NCT02650219|P2|Participant Flow|Control|"healthy subjects intervention: genetic analyses
genetic analyses"
4888|NCT02650219|P1|Participant Flow|Gaucher Disease Type 1|"Inclusion criteria:
Adult patients >= 18 years old
Gaucher disease type 1, proved by low betaglucosidase, with or without treatment
Patients must have read, understood and signed informed consent. intervention : genetic analyses
genetic analyses"
4889|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses
genetic analyses"
4890|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:
Adult patients >= 18 years old
Gaucher disease type 1, proved by low betaglucosidase, with or without treatment
Patients must have read, understood and signed informed consent. intervention : genetic analyses
genetic analyses"
4891|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses
genetic analyses"
4892|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:
Adult patients >= 18 years old
Gaucher disease type 1, proved by low betaglucosidase, with or without treatment
Patients must have read, understood and signed informed consent. intervention : genetic analyses
genetic analyses"
4893|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses
genetic analyses"
4894|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:
Adult patients >= 18 years old
Gaucher disease type 1, proved by low betaglucosidase, with or without treatment
Patients must have read, understood and signed informed consent. intervention : genetic analyses
genetic analyses"
4895|NCT02650219|E2|Reported Event|Control|"healthy subjects intervention: genetic analyses
genetic analyses"
4896|NCT02650219|E1|Reported Event|Gaucher Disease Type 1|"Inclusion criteria:
Adult patients >= 18 years old
Gaucher disease type 1, proved by low betaglucosidase, with or without treatment
Patients must have read, understood and signed informed consent. intervention : genetic analyses
genetic analyses"
4897|NCT02649634|B3|Baseline|Total|Total of all reporting groups
5025|NCT02645760|B3|Baseline|Total|Total of all reporting groups
4898|NCT02649634|B2|Baseline|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4899|NCT02649634|B1|Baseline|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4900|NCT02649634|P2|Participant Flow|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4901|NCT02649634|P1|Participant Flow|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4902|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4903|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4904|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4905|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
5017|NCT02646449|P2|Participant Flow|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
5416|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
4906|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4907|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4908|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4909|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4910|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4911|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4912|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4913|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
5018|NCT02646449|P1|Participant Flow|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
5153|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
4914|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4915|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4916|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4917|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4918|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4919|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4920|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4921|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
5019|NCT02646449|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
5154|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
4922|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4923|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4924|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4925|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4926|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4927|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4928|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4929|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
5020|NCT02646449|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
5155|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
4930|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4931|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4932|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4933|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4934|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4935|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4936|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4937|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
5021|NCT02646449|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
5156|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
4938|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4939|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4940|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4941|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4942|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4943|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4944|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4945|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
5022|NCT02646449|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
5157|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
4946|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4947|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4948|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4949|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4950|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4951|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4952|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4953|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
5023|NCT02646449|E2|Reported Event|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
5417|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
8036|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
4954|NCT02649634|E2|Reported Event|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.
Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
4955|NCT02649634|E1|Reported Event|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.
Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
4956|NCT02648438|B4|Baseline|Total|Total of all reporting groups
4957|NCT02648438|B3|Baseline|pMDI (Additional)|Pressurized metered-dose inhaler (pMDI)
4958|NCT02648438|B2|Baseline|IV, DPI 1, pMDI, Oral|IV formulation, monodose inhaler, pMDI, oral formulation
4959|NCT02648438|B1|Baseline|IV, DPI 1, DPI 2, Oral|IV formulation, monodose inhaler, multiple-dose DPI, oral formulation
4960|NCT02648438|P3|Participant Flow|pMDI (Additional)|Pressurized metered-dose inhaler (pMDI)
4961|NCT02648438|P2|Participant Flow|IV, DPI 1, pMDI, Oral|IV formulation, monodose inhaler, pMDI, oral formulation
4962|NCT02648438|P1|Participant Flow|IV, DPI 1, DPI 2, Oral|IV formulation, monodose inhaler, multiple-dose DPI, oral formulation
4963|NCT02648438|O6|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
4964|NCT02648438|O5|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
4965|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
4966|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
4967|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
4968|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
4969|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
4974|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
4975|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
4976|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
4977|NCT02648438|O6|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
4978|NCT02648438|O5|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
4979|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
4980|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
4981|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
4982|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
4983|NCT02648438|O6|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
4984|NCT02648438|O5|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
4985|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
4986|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
4987|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
4988|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
4989|NCT02648438|O2|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
4990|NCT02648438|O1|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
4991|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
4992|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
4993|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
4994|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
4995|NCT02648438|E6|Reported Event|pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (separate treatment)
4996|NCT02648438|E5|Reported Event|Oral Formulation|AZD7594 1200 μg oral formulation
4997|NCT02648438|E4|Reported Event|pMDI|AZD7594 400 μg delivered dose pMDI
4998|NCT02648438|E3|Reported Event|DPI Device 2|AZD7594 400 μg delivered dose multiple-dose DPI
4999|NCT02648438|E2|Reported Event|DPI Device 1|AZD7594 400 μg delivered dose monodose inhaler
5000|NCT02648438|E1|Reported Event|IV Formulation|AZD7594 150 μg IV formulation
5001|NCT02648022|B3|Baseline|Total|Total of all reporting groups
5002|NCT02648022|B2|Baseline|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
8037|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
5003|NCT02648022|B1|Baseline|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
5004|NCT02648022|P2|Participant Flow|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
5005|NCT02648022|P1|Participant Flow|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
5006|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
5007|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
5008|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
5047|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5009|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
5010|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
5011|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
5012|NCT02648022|E2|Reported Event|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
5013|NCT02648022|E1|Reported Event|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
5014|NCT02646449|B3|Baseline|Total|Total of all reporting groups
5015|NCT02646449|B2|Baseline|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
5158|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
8038|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
5026|NCT02645760|B2|Baseline|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
5027|NCT02645760|B1|Baseline|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
5028|NCT02645760|P2|Participant Flow|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
5029|NCT02645760|P1|Participant Flow|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
5030|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
5031|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
5032|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
5033|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
5034|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
5035|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
5036|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
5037|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
5159|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5418|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
5038|NCT02645760|E2|Reported Event|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
5039|NCT02645760|E1|Reported Event|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
5040|NCT02645123|B4|Baseline|Total|Total of all reporting groups
5041|NCT02645123|B3|Baseline|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5042|NCT02645123|B2|Baseline|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5043|NCT02645123|B1|Baseline|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5044|NCT02645123|P3|Participant Flow|Classic Physiotherapy|"This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)
Transcutaneous electrical nerve stimulation: Enraf-Nonius Sonopuls 692
swedish type massage: petrissage, effleurage, tapotement
muscle stretching: static hamstring stretching"
5045|NCT02645123|P2|Participant Flow|Sham Treatment|"The investigator touched the skin overlying the low back statically for 10 minutes
sham treatment: touching of the skin overlying the lumbar area"
5046|NCT02645123|P1|Participant Flow|Spinal Mobilization|"The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration
spinal mobilization: passive physiological intervertebral movements and passive accessory posteroanterior mobilization"
7956|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
5048|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5049|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5050|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5051|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5052|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5053|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5054|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5055|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5056|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5057|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5058|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
5059|NCT02645123|E3|Reported Event|Classic Physiotherapy|"This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)
Transcutaneous electrical nerve stimulation: Enraf-Nonius Sonopuls 692
swedish type massage: petrissage, effleurage, tapotement
muscle stretching: static hamstring stretching"
5060|NCT02645123|E2|Reported Event|Sham Treatment|"The investigator touched the skin overlying the low back statically for 10 minutes
sham treatment: touching of the skin overlying the lumbar area"
5061|NCT02645123|E1|Reported Event|Spinal Mobilization|"The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration
spinal mobilization: passive physiological intervertebral movements and passive accessory posteroanterior mobilization"
5062|NCT02644356|B1|Baseline|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.
Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
5063|NCT02644356|P1|Participant Flow|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.
Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
5064|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.
Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
5065|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.
Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
5066|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.
Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
5067|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.
Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
5068|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.
Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
5476|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care."
5069|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.
Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
5070|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.
Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
5071|NCT02644356|E1|Reported Event|Online CE/CME Course|All subjects were assigned to take the three course modules of an online CE/CME course and complete pre- and post-course data collection. Module topics consisted of acupuncture, massage, and music-related interventions
5072|NCT02644109|B3|Baseline|Total|Total of all reporting groups
5073|NCT02644109|B2|Baseline|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.
Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
5074|NCT02644109|B1|Baseline|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.
Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
5075|NCT02644109|P2|Participant Flow|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption.
Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols.
Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups.
Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.
Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
5160|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5161|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5076|NCT02644109|P1|Participant Flow|Phytosterols|"Milk powder: subjects will consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption.
Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols).
Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire), presence of symptoms and side effects will be determined. Then will be randomly assigned to one of the groups.
Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.
Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
5077|NCT02644109|O2|Outcome|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.
Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
5078|NCT02644109|O1|Outcome|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.
Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
5079|NCT02644109|E2|Reported Event|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.
Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
5131|NCT02643199|B1|Baseline|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.
90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.
Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
5519|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5080|NCT02644109|E1|Reported Event|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.
Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
5081|NCT02644096|B3|Baseline|Total|Total of all reporting groups
5082|NCT02644096|B2|Baseline|Intervention|"counselling and support after discharge from hospital
counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR"
5083|NCT02644096|B1|Baseline|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
5084|NCT02644096|P2|Participant Flow|Intervention|"counselling and support after discharge from hospital
counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR"
5085|NCT02644096|P1|Participant Flow|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
5086|NCT02644096|O2|Outcome|Intervention|"counselling and support after discharge from hospital
counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation.after THR."
5087|NCT02644096|O1|Outcome|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
5088|NCT02644096|E2|Reported Event|Intervention|"counselling and support after discharge from hospital
counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR."
5089|NCT02644096|E1|Reported Event|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
5090|NCT02643615|B3|Baseline|Total|Total of all reporting groups
5091|NCT02643615|B2|Baseline|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins"
5162|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5163|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5092|NCT02643615|B1|Baseline|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
5093|NCT02643615|P2|Participant Flow|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
5094|NCT02643615|P1|Participant Flow|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
5132|NCT02643199|P1|Participant Flow|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.
90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.
Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
5520|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5095|NCT02643615|O2|Outcome|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
5096|NCT02643615|O1|Outcome|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
5097|NCT02643615|O2|Outcome|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
5098|NCT02643615|O1|Outcome|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
5099|NCT02643615|O2|Outcome|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins"
5164|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5165|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5166|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5100|NCT02643615|O1|Outcome|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
5101|NCT02643615|O2|Outcome|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins"
5102|NCT02643615|O1|Outcome|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
5521|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5103|NCT02643615|E2|Reported Event|VEP Under Balanced Anesthesia|"Patients undergoing prone spine surgery will receive an anesthesia regimen using Desflurane as part of balanced general anesthesia
VEP under balanced anesth.: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Desflurane: Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be ins"
5104|NCT02643615|E1|Reported Event|VEP Under TIVA|"Patients undergoing prone spine surgery will receive an anesthesia regimen using propofol (TIVA) for maintenance
VEP under TIVA: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
Propofol: Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery."
5105|NCT02643251|B3|Baseline|Total|Total of all reporting groups
5106|NCT02643251|B2|Baseline|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator
Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
5107|NCT02643251|B1|Baseline|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%
Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
5108|NCT02643251|P2|Participant Flow|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator
Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
5109|NCT02643251|P1|Participant Flow|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%
Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
5110|NCT02643251|O2|Outcome|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator
Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
5111|NCT02643251|O1|Outcome|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%
Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
5112|NCT02643251|O2|Outcome|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator
Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
5113|NCT02643251|O1|Outcome|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%
Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
5114|NCT02643251|E2|Reported Event|Clonidine Hydrochloride Gel Comparator|"Clonidine Hydrochloride Gel Comparator
Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use."
5115|NCT02643251|E1|Reported Event|Clonidine Hydrochloride Topical Gel, 0.1%|"Clonidine Hydrochloride Topical Gel, 0.1%
Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use."
5116|NCT02643225|B3|Baseline|Total|Total of all reporting groups
5117|NCT02643225|B2|Baseline|Non Diabetic Pregnant Women|"control group
The investigation will be performed to non diabetic pregnant women:
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
5419|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
5118|NCT02643225|B1|Baseline|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
5119|NCT02643225|P2|Participant Flow|Non Diabetic Pregnant Women|"control group
The investigation will be performed to non diabetic pregnant women:
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.
During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock’s formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.
The cross sectional area of Wharton’s jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.
HbA1c levels will be measured for diabetes patients."
5130|NCT02643225|E1|Reported Event|Pregnant Women With Gestational Diabetes|"case group
The investigation will be performed to pregnant women with gestational diabetes
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
6642|NCT02596451|B3|Baseline|Placebo|Vehicle gel (Glenmark Pharmaceuticals Ltd)
5120|NCT02643225|P1|Participant Flow|Pregnant Women With Gestational Diabetes|"case group
The investigation will be performed to pregnant women with gestational diabetes
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.
During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock’s formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.
The cross sectional area of Wharton’s jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.
HbA1c levels will be measured for diabetes patients."
5121|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group
The investigation will be performed to non diabetic pregnant women:
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
5122|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group
The investigation will be performed to pregnant women with gestational diabetes
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
5123|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group
The investigation will be performed to non diabetic pregnant women:
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
5124|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group
The investigation will be performed to pregnant women with gestational diabetes
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
5125|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group
The investigation will be performed to non diabetic pregnant women:
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
5126|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
5127|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group
The investigation will be performed to non diabetic pregnant women:
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
5167|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5420|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
5128|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
5129|NCT02643225|E2|Reported Event|Non Diabetic Pregnant Women|"control group
The investigation will be performed to non diabetic pregnant women:
Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.
HbA1c levels will be measured for participants."
5239|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5133|NCT02643199|O1|Outcome|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.
90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.
Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
5134|NCT02643199|O1|Outcome|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.
90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.
Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
5135|NCT02643199|E1|Reported Event|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.
90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.
Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
5136|NCT02643004|B1|Baseline|Overall Baseline Characteristics|"Participants were randomized to wear senofilcon A or stenfilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
Stenfilcon A: contact lens"
5137|NCT02643004|P2|Participant Flow|Stenfilcon A, Then Senofilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
Senofilcon A: contact lens"
5138|NCT02643004|P1|Participant Flow|Senofilcon A, Then Stenfilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
Stenfilcon A: contact lens"
5139|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5140|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5141|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5142|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5143|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5144|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5145|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5146|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5147|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5148|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5149|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5150|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5151|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5152|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5421|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
5172|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5173|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5174|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5175|NCT02643004|E2|Reported Event|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens"
5176|NCT02643004|E1|Reported Event|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens"
5177|NCT02642575|B1|Baseline|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
5178|NCT02642575|P1|Participant Flow|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
5179|NCT02642575|O1|Outcome|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
5180|NCT02642575|O1|Outcome|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
5522|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5181|NCT02642575|O1|Outcome|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
5182|NCT02642575|E1|Reported Event|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
5183|NCT02642536|B3|Baseline|Total|Total of all reporting groups
5184|NCT02642536|B2|Baseline|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5185|NCT02642536|B1|Baseline|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5186|NCT02642536|P2|Participant Flow|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5187|NCT02642536|P1|Participant Flow|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 10 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 10 phone based clinician led CBT sessions"
5188|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5189|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5190|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5191|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5231|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5422|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
5192|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5193|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5194|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5195|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5196|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5197|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5198|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5199|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5200|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5201|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5202|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5203|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5204|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5205|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5206|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5207|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5208|NCT02642536|O2|Outcome|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5209|NCT02642536|O1|Outcome|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5210|NCT02642536|E2|Reported Event|Enhanced Usual Care|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided."
5211|NCT02642536|E1|Reported Event|MH MOVE|"provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions"
5212|NCT02641912|B3|Baseline|Total|Total of all reporting groups
5213|NCT02641912|B2|Baseline|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5214|NCT02641912|B1|Baseline|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5215|NCT02641912|P2|Participant Flow|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5263|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5216|NCT02641912|P1|Participant Flow|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 milliliter (mL) of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5217|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
5218|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
5219|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
5220|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
5221|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
5222|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
5223|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5224|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5225|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5226|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5227|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5228|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5229|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5230|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5386|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
5232|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5233|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5234|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5235|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5236|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5237|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
5238|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
5240|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5241|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5242|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5243|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5244|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5245|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
5246|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
5247|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
5248|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
5249|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
5250|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
5251|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
5252|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
5253|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
5254|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
5387|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
5388|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
5255|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5256|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5257|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5258|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5259|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
5260|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
5261|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5262|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5264|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5265|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5266|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5267|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5268|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5269|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5270|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5271|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5272|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5273|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5274|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5275|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5276|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5277|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5389|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
5390|NCT02639052|E2|Reported Event|Saline|Saline vehicle intradermally injected into the other forearm
8039|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
5278|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5279|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
5280|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
5281|NCT02641912|E2|Reported Event|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
5282|NCT02641912|E1|Reported Event|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
5283|NCT02641379|B12|Baseline|Total|Total of all reporting groups
5284|NCT02641379|B11|Baseline|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
5285|NCT02641379|B10|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
5286|NCT02641379|B9|Baseline|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5287|NCT02641379|B8|Baseline|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
5288|NCT02641379|B7|Baseline|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5289|NCT02641379|B6|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5290|NCT02641379|B5|Baseline|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
5291|NCT02641379|B4|Baseline|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5292|NCT02641379|B3|Baseline|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
5391|NCT02639052|E1|Reported Event|Botox|10 units of Botox intradermally injected into one forearm
5392|NCT02638493|B4|Baseline|Total|Total of all reporting groups
5293|NCT02641379|B2|Baseline|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5294|NCT02641379|B1|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5295|NCT02641379|P11|Participant Flow|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
5296|NCT02641379|P10|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (≤ 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
5477|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5297|NCT02641379|P9|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5298|NCT02641379|P8|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
5299|NCT02641379|P7|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5300|NCT02641379|P6|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5301|NCT02641379|P5|Participant Flow|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
5302|NCT02641379|P4|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a rapid virological response (RVR) at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5303|NCT02641379|P3|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (≥ 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
5393|NCT02638493|B3|Baseline|HIV Positive TAF|8 HIV positive men taking TAF as treatment
5394|NCT02638493|B2|Baseline|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
5395|NCT02638493|B1|Baseline|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
5396|NCT02638493|P3|Participant Flow|HIV Positive TAF|8 HIV positive men taking TAF (Tenofovir Alafenamide) as treatment
5304|NCT02641379|P2|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5305|NCT02641379|P1|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received pegylated interferon alpha-2a (PEG-IFN alfa-2a) at a dose of 180 microgram (mcg) subcutaneously (SC) once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 milligram/day (mg/day) [for participants with a body weight </= 75 kilogram (kg)] or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an early virological response (EVR) defined as non-detectable serum hepatitis C virus ribonucleic acid (HCV RNA) [< 600 international units/milliliter (IU/ml)] by quantitative polymerase chain reaction (PCR) or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5306|NCT02641379|O6|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
5478|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5479|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care."
5307|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
5308|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5309|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
5310|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5311|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5312|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
5313|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5314|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
5397|NCT02638493|P2|Participant Flow|HIV Negative|8 HIV negative men taking TDF/FTC (Tenofovir Disoproxil Fumarate/Emtricitabine) as pre-exposure prophylaxis
5398|NCT02638493|P1|Participant Flow|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC (Tenofovir Disoproxil Fumarate/Emtricitabine) as treatment
5315|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5316|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5317|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
7957|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
5318|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5319|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5320|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
5321|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5322|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5323|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5324|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
5325|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5399|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
5400|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
5401|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
5326|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
5327|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5328|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5329|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5330|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5331|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
5332|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5333|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
5334|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5335|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5336|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
5402|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
5403|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
5404|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
5337|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5338|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
5369|NCT02641249|B1|Baseline|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.
Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
5339|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5340|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5341|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5342|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5343|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5344|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5345|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5346|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
5405|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
5406|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
5347|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5348|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5349|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5350|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
5351|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5352|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5353|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
5354|NCT02641379|O2|Outcome|PEG-IFN Alfa 2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5355|NCT02641379|O1|Outcome|PEG-IFN Alfa 2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5356|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5407|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
5408|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
5409|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
5410|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
5357|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5358|NCT02641379|E11|Reported Event|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
5471|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5359|NCT02641379|E10|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
5360|NCT02641379|E9|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5361|NCT02641379|E8|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
5362|NCT02641379|E7|Reported Event|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5363|NCT02641379|E6|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5364|NCT02641379|E5|Reported Event|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
5365|NCT02641379|E4|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
5366|NCT02641379|E3|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
5367|NCT02641379|E2|Reported Event|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5411|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
5412|NCT02638493|O2|Outcome|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
5413|NCT02638493|O1|Outcome|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
5414|NCT02638493|O3|Outcome|HIV Positive TAF|8 HIV positive men taking TAF as treatment
8040|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
5368|NCT02641379|E1|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
5472|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5516|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5370|NCT02641249|P1|Participant Flow|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.
Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
5371|NCT02641249|O2|Outcome|Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.
Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
5372|NCT02641249|O1|Outcome|No Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.
Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
5373|NCT02641249|O2|Outcome|Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.
Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
5374|NCT02641249|O1|Outcome|No Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.
Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
5375|NCT02641249|O2|Outcome|Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.
Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
5376|NCT02641249|O1|Outcome|No Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.
Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
5377|NCT02641249|E1|Reported Event|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.
Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
5378|NCT02639052|B1|Baseline|Botox and Saline Vehicle Control|"10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle.
Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.
Saline: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit."
5379|NCT02639052|P1|Participant Flow|Botox and Saline Vehicle Control|"10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle.
Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.
Saline: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit."
5380|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
5381|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
5382|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
5383|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
5384|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
5385|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
5423|NCT02638493|E3|Reported Event|HIV Positive TAF|8 HIV positive men taking TAF as treatment
5424|NCT02638493|E2|Reported Event|HIV Negative|8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
5425|NCT02638493|E1|Reported Event|HIV Positive TDF/FTC|8 HIV positive men taking TDF/FTC as treatment
5426|NCT02638129|B3|Baseline|Total|Total of all reporting groups
5427|NCT02638129|B2|Baseline|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
5473|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care."
5428|NCT02638129|B1|Baseline|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
5429|NCT02638129|P2|Participant Flow|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
5430|NCT02638129|P1|Participant Flow|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
5431|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
5432|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
5433|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
5434|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
5435|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
5436|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
5437|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
5500|NCT02634788|B4|Baseline|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5438|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
5517|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5518|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5439|NCT02638129|E2|Reported Event|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
5440|NCT02638129|E1|Reported Event|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
5441|NCT02638051|B3|Baseline|Total|Total of all reporting groups
5442|NCT02638051|B2|Baseline|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
5443|NCT02638051|B1|Baseline|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.
Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
5444|NCT02638051|P2|Participant Flow|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter was occluded. Administered biweekly during four weeks of the course, totally two times.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
5445|NCT02638051|P1|Participant Flow|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.
Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
5446|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
5447|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.
Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
5448|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
5468|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5469|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5470|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care."
5474|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5475|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
7958|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
5449|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.
Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
5450|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
5451|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.
Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
5452|NCT02638051|E2|Reported Event|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
5453|NCT02638051|E1|Reported Event|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.
Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
5454|NCT02637063|B4|Baseline|Total|Total of all reporting groups
5455|NCT02637063|B3|Baseline|Usual Care|"No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care."
5456|NCT02637063|B2|Baseline|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5457|NCT02637063|B1|Baseline|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5458|NCT02637063|P3|Participant Flow|Usual Care|"No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care."
5459|NCT02637063|P2|Participant Flow|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5460|NCT02637063|P1|Participant Flow|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5461|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care."
5462|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5463|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5464|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care."
5465|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5466|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5467|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care."
5498|NCT02635425|E1|Reported Event|7 Eggs Collection|"Aspiration of 7 eggs only
7 eggs collection: vaginal US"
5499|NCT02634788|B5|Baseline|Total|Total of all reporting groups
8041|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
5480|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5481|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5482|NCT02637063|E3|Reported Event|Usual Care|"No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care."
5483|NCT02637063|E2|Reported Event|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5484|NCT02637063|E1|Reported Event|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
5485|NCT02635828|B1|Baseline|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.
Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.
Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.
Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
5486|NCT02635828|P1|Participant Flow|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.
Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.
Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.
Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
5487|NCT02635828|O1|Outcome|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.
Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.
Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.
Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
5488|NCT02635828|O1|Outcome|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.
Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.
Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.
Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
5489|NCT02635828|E1|Reported Event|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.
Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.
Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.
Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
5490|NCT02635425|B3|Baseline|Total|Total of all reporting groups
5491|NCT02635425|B2|Baseline|Full Eggs Collection|"Aspiration of all eggs
Full eggs collection: vaginal US"
5492|NCT02635425|B1|Baseline|7 Eggs Collection|"Aspiration of 7 eggs only
7 eggs collection: vaginal US"
5493|NCT02635425|P2|Participant Flow|Full Eggs Collection|"Aspiration of all eggs
Full eggs collection: vaginal US"
5494|NCT02635425|P1|Participant Flow|7 Eggs Collection|"Aspiration of 7 eggs only
7 eggs collection: vaginal US"
5495|NCT02635425|O2|Outcome|Full Eggs Collection|"Aspiration of all eggs
Full eggs collection: vaginal US"
5496|NCT02635425|O1|Outcome|7 Eggs Collection|"Aspiration of 7 eggs only
7 eggs collection: vaginal US"
5497|NCT02635425|E2|Reported Event|Full Eggs Collection|"Aspiration of all eggs
Full eggs collection: vaginal US"
5501|NCT02634788|B3|Baseline|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5502|NCT02634788|B2|Baseline|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5503|NCT02634788|B1|Baseline|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5504|NCT02634788|P4|Participant Flow|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5505|NCT02634788|P3|Participant Flow|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5506|NCT02634788|P2|Participant Flow|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5507|NCT02634788|P1|Participant Flow|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5508|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5509|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5510|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5511|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5512|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5513|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5514|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5515|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
7959|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
5523|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5524|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5525|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5526|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5527|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5528|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5529|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5530|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5531|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5532|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5533|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5534|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5535|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5536|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5537|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5538|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5539|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5540|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5541|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5542|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5543|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5544|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5545|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5546|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5547|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
7133|NCT02576639|O3|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
5548|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5549|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5550|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5551|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5552|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5553|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5554|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5555|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5556|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5557|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5558|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5559|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5560|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5561|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5562|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5563|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5564|NCT02634788|O4|Outcome|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5565|NCT02634788|O3|Outcome|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5566|NCT02634788|O2|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5567|NCT02634788|O1|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5568|NCT02634788|E4|Reported Event|Buprenorphine 0.125 mg TID|Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
5569|NCT02634788|E3|Reported Event|Buprenorphine 0.25 mg TID|Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
5570|NCT02634788|E2|Reported Event|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days.
5571|NCT02634788|E1|Reported Event|Placebo|Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days.
5572|NCT02634073|B1|Baseline|All Treatment Groups Combined|Sixteen participants were randomized to receive one of the following 4 treatment sequences : Treatment sequence 1 : ABCD; Treatment sequence 2: DABC; Trearment sequence 3: BCDA; Treatment sequence 4: CDAB; where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g.
5573|NCT02634073|P4|Participant Flow|Treatment Sequence 4: DCAB|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
5574|NCT02634073|P3|Participant Flow|Treatment Sequence 3: CBDA|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
5575|NCT02634073|P2|Participant Flow|Treatment Sequence 2: BACD|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
5576|NCT02634073|P1|Participant Flow|Treatment Sequence 1: ADBC|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
5577|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5578|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5579|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5580|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5662|NCT02633787|P1|Participant Flow|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
8042|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
5581|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5582|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5583|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5584|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5585|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5586|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5587|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5588|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5589|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5715|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
5590|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5591|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5592|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5593|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5594|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5595|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5596|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5597|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5598|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5599|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5600|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5663|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
8043|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
5601|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5602|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5603|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5604|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5605|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5606|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5607|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5608|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5609|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5610|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5611|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5612|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5613|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5614|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5615|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5616|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5617|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5618|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5619|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5620|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5664|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
8044|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
5621|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5622|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5623|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5624|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5625|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5626|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5627|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5628|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5629|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5630|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5631|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5632|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5633|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5634|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5635|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5636|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5637|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5638|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5639|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5640|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5665|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
8045|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
5641|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5642|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5643|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5644|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5645|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5646|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5647|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5648|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5649|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5650|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5651|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5652|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5653|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5654|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5655|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5656|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5657|NCT02634073|E4|Reported Event|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5658|NCT02634073|E3|Reported Event|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5659|NCT02634073|E2|Reported Event|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5660|NCT02634073|E1|Reported Event|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
5661|NCT02633787|B1|Baseline|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
5666|NCT02633787|E1|Reported Event|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
5667|NCT02633215|B3|Baseline|Total|Total of all reporting groups
5668|NCT02633215|B2|Baseline|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5669|NCT02633215|B1|Baseline|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5670|NCT02633215|P2|Participant Flow|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5671|NCT02633215|P1|Participant Flow|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5672|NCT02633215|O2|Outcome|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5716|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
7960|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
5673|NCT02633215|O1|Outcome|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5674|NCT02633215|O2|Outcome|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5675|NCT02633215|O1|Outcome|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5676|NCT02633215|O2|Outcome|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5677|NCT02633215|O1|Outcome|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5678|NCT02633215|E2|Reported Event|Sham Stimulation With Motor Training|"2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5679|NCT02633215|E1|Reported Event|Active Stimulation With Motor Training|"2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb’s point, radial and median nerves paired with task-oriented therapy"
5680|NCT02632812|B3|Baseline|Total|Total of all reporting groups
5681|NCT02632812|B2|Baseline|Placebo|"Placebo effervescent granules (oral) Twice daily
Placebo effervescent granules
Naproxen tablet"
5682|NCT02632812|B1|Baseline|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)
Rebamipide effervescent granules
Naproxen tablet"
7134|NCT02576639|O2|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
5683|NCT02632812|P2|Participant Flow|Placebo|"Placebo effervescent granules (oral) Twice daily
Placebo effervescent granules
Naproxen tablet"
5684|NCT02632812|P1|Participant Flow|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)
Rebamipide effervescent granules
Naproxen tablet"
5685|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days
Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5686|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days
Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5687|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days
Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5688|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days
Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5689|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days
Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5690|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days
Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5691|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days
Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5692|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days
Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
7219|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
5693|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days
Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5694|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days
Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5695|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days
Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5696|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days
Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5697|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days
Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5698|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days
Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days
Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
5699|NCT02632812|E2|Reported Event|Placebo|"Placebo effervescent granules (oral) Twice daily
Placebo effervescent granules
Naproxen tablet"
5700|NCT02632812|E1|Reported Event|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)
Rebamipide effervescent granules
Naproxen tablet"
5701|NCT02630563|B1|Baseline|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
5702|NCT02630563|P1|Participant Flow|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
5703|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16.
5704|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16.
5705|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
5706|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
5707|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
5799|NCT02625844|B1|Baseline|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
5708|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
5709|NCT02630563|E1|Reported Event|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
5710|NCT02629354|B3|Baseline|Total|Total of all reporting groups
5711|NCT02629354|B2|Baseline|Test - Ref|Subjects received the test product (Test) which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a FDC under fed conditions. After a washout period of at least 6 calendar days, the subjects received the reference product (Ref), which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
5712|NCT02629354|B1|Baseline|Ref - Test|Subjects received the reference product (Ref) which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra) under fed conditions. After a washout period of at least 6 calendar days, the subjects received the test product (Test), which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a fixed dose combination (FDC), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
5713|NCT02629354|P2|Participant Flow|Test - Ref|Subjects received the test product (Test) which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a FDC under fed conditions. After a washout period of at least 6 calendar days, the subjects received the reference product (Ref), which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
5714|NCT02629354|P1|Participant Flow|Ref - Test|Subjects received the reference product (Ref) which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra) under fed conditions. After a washout period of at least 6 calendar days, the subjects received the test product (Test), which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a fixed dose combination (FDC), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
5717|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
5718|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
5719|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
5720|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
5721|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
5722|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
5723|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
5724|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
5725|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
5726|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
5727|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
5728|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
5729|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
5730|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
5731|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
5732|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
5733|NCT02629354|E2|Reported Event|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
5734|NCT02629354|E1|Reported Event|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
5735|NCT02628938|B4|Baseline|Total|Total of all reporting groups
5736|NCT02628938|B3|Baseline|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days
Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
5737|NCT02628938|B2|Baseline|Miswak Sticks|"Sticks twice a day for 7 days
Miswak stick: Miswak stick twice a day for 7 days"
5738|NCT02628938|B1|Baseline|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days
Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
5739|NCT02628938|P3|Participant Flow|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days
Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
5740|NCT02628938|P2|Participant Flow|Miswak Sticks|"Sticks twice a day for 7 days
Miswak stick: Miswak stick twice a day for 7 days"
8046|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
5741|NCT02628938|P1|Participant Flow|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days
Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
5742|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days
Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
5743|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days
Miswak stick: Miswak stick twice a day for 7 days"
5744|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days
Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
5745|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days
Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
5746|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days
Miswak stick: Miswak stick twice a day for 7 days"
5747|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days
Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
5748|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days
Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
5749|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days
Miswak stick: Miswak stick twice a day for 7 days"
5750|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days
Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
5751|NCT02628938|E3|Reported Event|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days
Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
5752|NCT02628938|E2|Reported Event|Miswak Sticks|"Sticks twice a day for 7 days
Miswak stick: Miswak stick twice a day for 7 days"
5753|NCT02628938|E1|Reported Event|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days
Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
5754|NCT02628418|B3|Baseline|Total|Total of all reporting groups
5813|NCT02625298|E1|Reported Event|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment
ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
5814|NCT02625233|B3|Baseline|Total|Total of all reporting groups
5755|NCT02628418|B2|Baseline|Control Group|"The patients in the Control Group underwent to following interventions:
General Rehabilitation
Specific Hand Rehabilitation (SHR) performed by physiotherapist
General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.
SHR performed by physiotherapist: The activities were:
Flexion-extension of the fingers (10 min);
Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
Adduction and abduction of the fingers (10 min);
Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
5756|NCT02628418|B1|Baseline|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device
GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.
SHR by Gloreha device: Each training session consisted of six parts:
A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);
7 min of a number sequence (counting from one to five);
A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)
A sequence of wave-like finger movements (7 min)
A sequence of fist opening/closing (7 min)
A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
5757|NCT02628418|P2|Participant Flow|Control Group|"The patients in the Control Group underwent to following interventions:
General Rehabilitation (GR)
Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
Flexion-extension of the fingers (10 min);
Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
Adduction and abduction of the fingers (10 min);
Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
5758|NCT02628418|P1|Participant Flow|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
5759|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:
General Rehabilitation (GR)
Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
Flexion-extension of the fingers (10 min);
Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
Adduction and abduction of the fingers (10 min);
Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
5778|NCT02628106|B1|Baseline|Lipo-prostaglandin E1|"all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.
Lipo-PGE1: all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days"
5779|NCT02628106|P1|Participant Flow|Diabetic Nephropathy,Chronic Kidney Disease|all patients receivedlipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
5760|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
5761|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:
General Rehabilitation (GR)
Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
Flexion-extension of the fingers (10 min);
Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
Adduction and abduction of the fingers (10 min);
Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
5762|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
5785|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
5763|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:
General Rehabilitation (GR)
Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
Flexion-extension of the fingers (10 min);
Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
Adduction and abduction of the fingers (10 min);
Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
5764|NCT02628418|O1|Outcome|Gloreha Group|"TThe patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
5765|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:
General Rehabilitation (GR)
Specific hand rehabilitation (SHR) performed by physiotherapist GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
Flexion-extension of the fingers (10 min);
Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
Adduction and abduction of the fingers (10 min);
Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
5766|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
5767|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
5768|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:
General Rehabilitation (GR)
Specific hand rehabilitation (SHR) performed by physiotherapist GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR on performed by physiotherapist: The activities were:
Flexion-extension of the fingers (10 min);
Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
Adduction and abduction of the fingers (10 min);
Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
5780|NCT02628106|O1|Outcome|Diabetic Nephropathy,Chronic Kidney Disease|all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
5781|NCT02628106|E1|Reported Event|Diabetic Nephropathy,Chronic Kidney Disease|all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
8047|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
5769|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
5770|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:
General Rehabilitation
Specific hand rehabilitation performed by physiotherapist
General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.
Specific hand rehabilitation performed by physiotherapist: The activities were:
Flexion-extension of the fingers (10 min);
Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
Adduction and abduction of the fingers (10 min);
Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
5786|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
5771|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
5772|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:
General Rehabilitation (GR)
Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
Flexion-extension of the fingers (10 min);
Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
Adduction and abduction of the fingers (10 min);
Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
5773|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);
7 min of a number sequence (counting from one to five);
A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)
A sequence of wave-like finger movements (7 min)
A sequence of fist opening/closing (7 min)
A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
5774|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:
General Rehabilitation (GR)
Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
Flexion-extension of the fingers (10 min);
Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
Adduction and abduction of the fingers (10 min);
Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
5775|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
5776|NCT02628418|E2|Reported Event|Control Group|"The patients in the Control Group underwent to following interventions:
General Rehabilitation
Specific hand rehabilitation performed by physiotherapist
General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.
Specific hand rehabilitation performed by physiotherapist: The activities were:
Flexion-extension of the fingers (10 min);
Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
Adduction and abduction of the fingers (10 min);
Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
5777|NCT02628418|E1|Reported Event|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:
General Rehabilitation (GR)
Specific Hand Rehabilitation (SHR) by Gloreha device
GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.
SHR by Gloreha device: Each training session consisted of six parts:
A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);
7 min of a number sequence (counting from one to five);
A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)
A sequence of wave-like finger movements (7 min)
A sequence of fist opening/closing (7 min)
A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
7139|NCT02576639|E2|Reported Event|CNP520 2mg|CNP520 2 mg was taken qd orally for 13 weeks.
5782|NCT02627144|B1|Baseline|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
5783|NCT02627144|P1|Participant Flow|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
5784|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
7220|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
5787|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
5788|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
5789|NCT02627144|E1|Reported Event|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
5790|NCT02627001|B3|Baseline|Total|Total of all reporting groups
5791|NCT02627001|B2|Baseline|Standard Bag Valve Mask First, Then Numask Intraoral Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a Nu-Mask Intraoral Airway Device.
Bag Valve Mask: Conventional bag valve mask"
5792|NCT02627001|B1|Baseline|NuMask Intraoral Mask First, Then Standard Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a standard bag valve mask.
NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
5793|NCT02627001|P2|Participant Flow|Standard Bag Valve Mask First, Then Numask Intraoral Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using an intraoral mask.
Bag Valve Mask: Conventional bag valve mask"
5794|NCT02627001|P1|Participant Flow|NuMask Intraoral Mask First, Then Standard Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using a conventional cuffed face mask.
NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
5795|NCT02627001|O2|Outcome|Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.
Bag Valve Mask: Conventional bag valve mask"
5796|NCT02627001|O1|Outcome|NuMask Intraoral Airway Device|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.
NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
5797|NCT02627001|E2|Reported Event|Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.
Bag Valve Mask: Conventional bag valve mask"
5798|NCT02627001|E1|Reported Event|NuMask Intraoral Airway Device|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.
NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
5800|NCT02625844|P1|Participant Flow|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
5801|NCT02625844|O1|Outcome|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
5802|NCT02625844|E1|Reported Event|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
5803|NCT02625298|B3|Baseline|Total|Total of all reporting groups
5804|NCT02625298|B2|Baseline|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
5805|NCT02625298|B1|Baseline|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment
ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
5806|NCT02625298|P2|Participant Flow|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
5807|NCT02625298|P1|Participant Flow|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment
ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
5808|NCT02625298|O2|Outcome|MTA+ Cercamed|Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
5809|NCT02625298|O1|Outcome|ProRoot MTA|Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment
5810|NCT02625298|O2|Outcome|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
5811|NCT02625298|O1|Outcome|ProRoot MTA|"Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment
ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA)."
5812|NCT02625298|E2|Reported Event|MTA+ Cercamed|"Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland)."
7961|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
5815|NCT02625233|B2|Baseline|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
5816|NCT02625233|B1|Baseline|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire duration of the study.
5817|NCT02625233|P2|Participant Flow|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
5818|NCT02625233|P1|Participant Flow|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire duration of the study.
5819|NCT02625233|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
5820|NCT02625233|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens througout the entire duration of the study.
5821|NCT02625233|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
5822|NCT02625233|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens througout the entire duration of the study.
5823|NCT02625233|E2|Reported Event|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire duration of the study.
5824|NCT02625233|E1|Reported Event|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire duration of the study.
5825|NCT02625220|B1|Baseline|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
5826|NCT02625220|P1|Participant Flow|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
5827|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
5828|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
5829|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
5830|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
5831|NCT02625220|E1|Reported Event|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
5832|NCT02625207|B5|Baseline|Total|Total of all reporting groups
5833|NCT02625207|B4|Baseline|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5834|NCT02625207|B3|Baseline|Part 1 and 2: Cohort 3 - Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
5835|NCT02625207|B2|Baseline|Part 1: Cohort 2 - One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5836|NCT02625207|B1|Baseline|Part 1 and Part 2: Cohort 1 -No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
5837|NCT02625207|P4|Participant Flow|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
6046|NCT02617888|E3|Reported Event|Observational Arm|Observational evaluating the dose-related impact of radiation exposure from multiple sources and types on changes in double-stranded DNA breaks.
5838|NCT02625207|P3|Participant Flow|Part 1 and 2: Cohort 3 - Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
5839|NCT02625207|P2|Participant Flow|Part 1: Cohort 2 - One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5840|NCT02625207|P1|Participant Flow|Part 1 and Part 2: Cohort 1 -No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 milligram (mg) tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
5841|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5842|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5843|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5844|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5845|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5846|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5847|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5848|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5849|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5850|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5851|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5852|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5853|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5854|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5855|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5856|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5857|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5858|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5859|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5860|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5861|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5862|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5863|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5864|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5865|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5866|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5867|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5868|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5869|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5870|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5871|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5872|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5873|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5874|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5875|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5876|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5946|NCT02621034|O1|Outcome|Reciproc|"rotary reciprocating protocol
Reciproc: reciprocating rotary instrument"
5877|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5878|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5879|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5880|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5881|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5882|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5883|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5884|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5885|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5886|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5887|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5888|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5889|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5890|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5891|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5892|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5893|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5894|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
6461|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
5895|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5896|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5897|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5898|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
5899|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5900|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5901|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5902|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5903|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
5904|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
5947|NCT02621034|O3|Outcome|One Shape|"one shape continuous rotation protocol
One shape: full rotation protocol"
5905|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5906|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5907|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5908|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5909|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5910|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5911|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5912|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5913|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
5914|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5915|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5916|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5917|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5918|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5919|NCT02625207|E6|Reported Event|Part 2: Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5920|NCT02625207|E5|Reported Event|Part 2: Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
5921|NCT02625207|E4|Reported Event|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5922|NCT02625207|E3|Reported Event|Part 1: Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5923|NCT02625207|E2|Reported Event|Part 1: Cohort 2- One CYP3A5*1 Allele|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5924|NCT02625207|E1|Reported Event|Part 1: Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
5925|NCT02624791|B1|Baseline|All Study Participants|
5926|NCT02624791|P6|Participant Flow|Lens Sequence 6|Toric; Sphere; None
5927|NCT02624791|P5|Participant Flow|Lens Sequence 5|Toric; None; Sphere
5928|NCT02624791|P4|Participant Flow|Lens Sequence 4|Sphere; Toric; None
5929|NCT02624791|P3|Participant Flow|Lens Sequence 3|Sphere; None; Toric
5930|NCT02624791|P2|Participant Flow|Lens Sequence 2|None; Toric; Sphere
5931|NCT02624791|P1|Participant Flow|Lens Sequence 1|None; Sphere; Toric
5932|NCT02624791|O1|Outcome|Contact Lens Rx|All study participants
5933|NCT02624791|O1|Outcome|Contact Lens Rx|All study participants
5934|NCT02624791|E1|Reported Event|Contact Lens Rx|None; Sphere; Toric
5935|NCT02621034|B4|Baseline|Total|Total of all reporting groups
5936|NCT02621034|B3|Baseline|One Shape|"one shape continuous rotation protocol
One shape: full rotation protocol"
5937|NCT02621034|B2|Baseline|Reciproc|"rotary reciprocating protocol
Reciproc: reciprocating rotary instrument"
5938|NCT02621034|B1|Baseline|Control|"K-file hand instrumentation
Control: K-file hand instrumentation"
5939|NCT02621034|P3|Participant Flow|One Shape|"one shape continuous rotation protocol
One shape: full rotation protocol"
5940|NCT02621034|P2|Participant Flow|Reciproc|"rotary reciprocating protocol
Reciproc: reciprocating rotary instrument"
5941|NCT02621034|P1|Participant Flow|k File|"hand instrumentation
k file: hand instrumentation"
5942|NCT02621034|O3|Outcome|One Shape|"one shape continuous rotation protocol
One shape: full rotation protocol"
5943|NCT02621034|O2|Outcome|Reciproc|"rotary reciprocating protocol
Reciproc: reciprocating rotary instrument"
5944|NCT02621034|O1|Outcome|Control|"K-file hand instrumentation
Control: K-file hand instrumentation"
5945|NCT02621034|O2|Outcome|One Shape|"one shape continuous rotation protocol
One shape: full rotation protocol"
5948|NCT02621034|O2|Outcome|Reciproc|"rotary reciprocating protocol
Reciproc: reciprocating rotary instrument"
5949|NCT02621034|O1|Outcome|Control|"K-file hand instrumentation
Control: K-file hand instrumentation"
5950|NCT02621034|E3|Reported Event|One Shape|"one shape continuous rotation protocol
One shape: full rotation protocol"
5951|NCT02621034|E2|Reported Event|Reciproc|"rotary reciprocating protocol
Reciproc: reciprocating rotary instrument"
5952|NCT02621034|E1|Reported Event|Control|"K-file hand instrumentation
Control: K-file hand instrumentation"
5953|NCT02619812|B5|Baseline|Total|Total of all reporting groups
5954|NCT02619812|B4|Baseline|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
5955|NCT02619812|B3|Baseline|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
5956|NCT02619812|B2|Baseline|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
5957|NCT02619812|B1|Baseline|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
5958|NCT02619812|P4|Participant Flow|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
5959|NCT02619812|P3|Participant Flow|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
5960|NCT02619812|P2|Participant Flow|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
5961|NCT02619812|P1|Participant Flow|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
5962|NCT02619812|O4|Outcome|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
5963|NCT02619812|O3|Outcome|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
5964|NCT02619812|O2|Outcome|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
5965|NCT02619812|O1|Outcome|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
5966|NCT02619812|O4|Outcome|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
5967|NCT02619812|O3|Outcome|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
5968|NCT02619812|O2|Outcome|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
5969|NCT02619812|O1|Outcome|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
5970|NCT02619812|E4|Reported Event|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
5971|NCT02619812|E3|Reported Event|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
5972|NCT02619812|E2|Reported Event|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
5973|NCT02619812|E1|Reported Event|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
5974|NCT02619799|B3|Baseline|Total|Total of all reporting groups
5975|NCT02619799|B2|Baseline|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
8048|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
5976|NCT02619799|B1|Baseline|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5977|NCT02619799|P2|Participant Flow|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5978|NCT02619799|P1|Participant Flow|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5979|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5980|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5981|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5982|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5983|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5984|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5985|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5986|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5987|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5988|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5989|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5990|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5991|NCT02619799|E2|Reported Event|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
6045|NCT02617888|O1|Outcome|No Breast Shields|"Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care).
CCTA: Breast shield placement (randomized) among women."
5992|NCT02619799|E1|Reported Event|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
5993|NCT02619591|B3|Baseline|Total|Total of all reporting groups
5994|NCT02619591|B2|Baseline|Ultrasound Imaging - Multiple Views|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient
Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine."
5995|NCT02619591|B1|Baseline|Ultrasound Imaging - Single View|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient
Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine."
5996|NCT02619591|P2|Participant Flow|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient
Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
5997|NCT02619591|P1|Participant Flow|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient
Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
5998|NCT02619591|O2|Outcome|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient
Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
5999|NCT02619591|O1|Outcome|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient
Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
6000|NCT02619591|E2|Reported Event|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient
Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
6001|NCT02619591|E1|Reported Event|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient
Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
6002|NCT02618772|B3|Baseline|Total|Total of all reporting groups
6003|NCT02618772|B2|Baseline|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6004|NCT02618772|B1|Baseline|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6005|NCT02618772|P2|Participant Flow|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6006|NCT02618772|P1|Participant Flow|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6007|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6008|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6009|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6010|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6011|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6012|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6013|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6014|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6015|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6016|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6462|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
6017|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6018|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6019|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6020|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6021|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6022|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6023|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6024|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6025|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6026|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6027|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6028|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6029|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6030|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6031|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6032|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6033|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6034|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6035|NCT02618772|E2|Reported Event|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300
Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
6036|NCT02618772|E1|Reported Event|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300
Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
6037|NCT02617888|B4|Baseline|Total|Total of all reporting groups
6038|NCT02617888|B3|Baseline|Observational Arm|1. Non-female patients undergoing coronary CTA; 2. Patients undergoing nuclear cardiology stress testing; 3. Patients undergoing invasive coronary angiography.
6039|NCT02617888|B2|Baseline|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
6040|NCT02617888|B1|Baseline|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
6041|NCT02617888|P3|Participant Flow|Observational|Non-female patients undergoing coronary CTA, patients undergoing nuclear cardiology studies and invasive coronary angiography.
6042|NCT02617888|P2|Participant Flow|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
6043|NCT02617888|P1|Participant Flow|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
6044|NCT02617888|O2|Outcome|Breast Shields|"Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care).
CCTA: Breast shield placement (randomized) among women."
8049|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
6047|NCT02617888|E2|Reported Event|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
6048|NCT02617888|E1|Reported Event|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
6049|NCT02617784|B3|Baseline|Total|Total of all reporting groups
6050|NCT02617784|B2|Baseline|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6051|NCT02617784|B1|Baseline|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6052|NCT02617784|P2|Participant Flow|Oseltamivir With CAPD|Participants on continuous ambulatory peritoneal dialysis (CAPD) received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6053|NCT02617784|P1|Participant Flow|Oseltamivir With HD|Participants on hemodialysis (HD) received 9 doses of 30-milligram (mg) oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6054|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6055|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6056|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6141|NCT02614924|O1|Outcome|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group
Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
6057|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6058|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6059|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6060|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6061|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6062|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6063|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6064|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6065|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6066|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6067|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6068|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6069|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6070|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6071|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6072|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
7510|NCT02568852|B1|Baseline|Group 1|Laparoscopic cholecystectomy in under 10 mmHg pneumoperitoneum
6073|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6074|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6075|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6076|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6077|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6078|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6079|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6080|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6318|NCT02609841|O1|Outcome|<3 K Dialysate Patients|Subjects on <3 K dialysate and received all 6 hemodialysis treatments over 12 days.
6081|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6082|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6083|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6084|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6085|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6086|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6087|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6088|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6089|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6090|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6091|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6092|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6093|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6094|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6095|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6096|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6157|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6097|NCT02617784|E2|Reported Event|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
6098|NCT02617784|E1|Reported Event|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
6099|NCT02616523|B4|Baseline|Total|Total of all reporting groups
6100|NCT02616523|B3|Baseline|Placebo|"The placebo group will receive intravenous infusion of normal saline only.
placebo: The participants will be given infusion of normal saline intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6101|NCT02616523|B2|Baseline|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.
Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6102|NCT02616523|B1|Baseline|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.
Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6103|NCT02616523|P3|Participant Flow|Placebo|"The placebo group will receive intravenous infusion of normal saline only.
placebo: The participants will be given infusion of normal saline intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6137|NCT02614924|P1|Participant Flow|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group
Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
6104|NCT02616523|P2|Participant Flow|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.
Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6105|NCT02616523|P1|Participant Flow|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.
Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6106|NCT02616523|O3|Outcome|Placebo|Participants received fentanyl boluses during the operation
6107|NCT02616523|O2|Outcome|Lidocaine|Participants received lidocaine infusion intraoperatively 1,5 mg/kg/h
6108|NCT02616523|O1|Outcome|Dexmedetomidine|Participants received dexmedetomidine infusion intraoperatively 0,5 mcg/kg/h
6109|NCT02616523|O3|Outcome|Placebo|Participants received fentanyl boluses during the operation
6110|NCT02616523|O2|Outcome|Lidocaine|Participants received lidocaine infusion intraoperatively 1,5 mg/kg/h
6111|NCT02616523|O1|Outcome|Dexmedetomidine|Participants received dexmedetomidine infusion intraoperatively 0,5 mcg/kg/h
6112|NCT02616523|O3|Outcome|Placebo|"The placebo group will receive intravenous infusion of normal saline only.
placebo: The participants will be given infusion of normal saline intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6113|NCT02616523|O2|Outcome|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.
Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6114|NCT02616523|O1|Outcome|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.
Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6115|NCT02616523|E3|Reported Event|Placebo|"The placebo group will receive intravenous infusion of normal saline only.
placebo: The participants will be given infusion of normal saline intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6116|NCT02616523|E2|Reported Event|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.
Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6117|NCT02616523|E1|Reported Event|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.
Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.
Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
6118|NCT02615717|B3|Baseline|Total|Total of all reporting groups
6119|NCT02615717|B2|Baseline|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.
Attention Bias Modification: comparison of treatment versus control"
6158|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6159|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6120|NCT02615717|B1|Baseline|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).
Attention Bias Modification: comparison of treatment versus control"
6121|NCT02615717|P2|Participant Flow|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.
Attention Bias Modification: comparison of treatment versus control"
6122|NCT02615717|P1|Participant Flow|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).
Attention Bias Modification: comparison of treatment versus control"
6138|NCT02614924|O2|Outcome|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS
6139|NCT02614924|O1|Outcome|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group
Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
6123|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.
Attention Bias Modification: comparison of treatment versus control"
6124|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).
Attention Bias Modification: comparison of treatment versus control"
6125|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.
Attention Bias Modification: comparison of treatment versus control"
6126|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).
Attention Bias Modification: comparison of treatment versus control"
6127|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.
Attention Bias Modification: comparison of treatment versus control"
6128|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).
Attention Bias Modification: comparison of treatment versus control"
6129|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.
Attention Bias Modification: comparison of treatment versus control"
6130|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).
Attention Bias Modification: comparison of treatment versus control"
8050|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
6131|NCT02615717|E2|Reported Event|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.
Attention Bias Modification: comparison of treatment versus control"
6132|NCT02615717|E1|Reported Event|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).
Attention Bias Modification: comparison of treatment versus control"
6133|NCT02614924|B3|Baseline|Total|Total of all reporting groups
6134|NCT02614924|B2|Baseline|Pentax AWS Videolaryngoscope Group|Randomly allocated Pentax AWS videolaryngoscope and intubated using Pentax AWS videolaryngoscope
6135|NCT02614924|B1|Baseline|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group
Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
6136|NCT02614924|P2|Participant Flow|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS
6140|NCT02614924|O2|Outcome|Pentax AWS Videolaryngoscope|randomly allocated to Pentax AWs
6142|NCT02614924|E2|Reported Event|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS group Pentax AWS videolaryngoscope group: Patient intubated with Pentax AWS
6143|NCT02614924|E1|Reported Event|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group
Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
6144|NCT02614586|B1|Baseline|Part-1: Screening Phase|Participants received 2 P50 electroencephalography (EEG) sessions, first session was conducted in the morning, and second session was conducted in the afternoon. Participants did not receive any study medication in Screening Phase (Part-1) of the study.
6145|NCT02614586|P1|Participant Flow|Part-1: Screening Phase|Participants received 2 P50 electroencephalography (EEG) sessions, first session was conducted in the morning, and second session was conducted in the afternoon. Participants did not receive any study medication in Screening Phase (Part-1) of the study.
6146|NCT02614586|O1|Outcome|Part 2: TAK-058 and Ondansetron|In Treatment Phase (Part 2) of the study, participants were planned to be randomized into 3-period cross-over treatment phase with single oral dose of 1 of the 3 regimens in each period: TAK-058, ondansetron, and placebo. Participants were planned to receive treatment in following 6 sequences: placebo, TAK-058, and ondansetron; TAK-058, placebo, and ondansetron; ondansetron, placebo, and TAK-058; placebo, ondansetron, and TAK-058; TAK-058, ondansetron, and placebo; and ondansetron, TAK-058, and placebo in intervention period 1, 2, and 3 respectively. A washout period of at least 7 days was planned to be maintained between each intervention period.
6147|NCT02614586|O1|Outcome|Part 2: TAK-058 and Ondansetron|In Treatment Phase (Part 2) of the study, participants were planned to be randomized into 3-period cross-over treatment phase with single oral dose of 1 of the 3 regimens in each period: TAK-058, ondansetron, and placebo. Participants were planned to receive treatment in following 6 sequences: placebo, TAK-058, and ondansetron; TAK-058, placebo, and ondansetron; ondansetron, placebo, and TAK-058; placebo, ondansetron, and TAK-058; TAK-058, ondansetron, and placebo; and ondansetron, TAK-058, and placebo in intervention period 1, 2, and 3 respectively. A washout period of at least 7 days was planned to be maintained between each intervention period.
6148|NCT02614586|E1|Reported Event|Part 2: TAK-058 and Ondansetron|In Treatment Phase (Part 2) of the study, participants were planned to be randomized into 3-period cross-over treatment phase with single oral dose of 1 of the 3 regimens in each period: TAK-058, ondansetron, and placebo. Participants were planned to receive treatment in following 6 sequences: placebo, TAK-058, and ondansetron; TAK-058, placebo, and ondansetron; ondansetron, placebo, and TAK-058; placebo, ondansetron, and TAK-058; TAK-058, ondansetron, and placebo; and ondansetron, TAK-058, and placebo in intervention period 1, 2, and 3 respectively. A washout period of at least 7 days was planned to be maintained between each intervention period.
6149|NCT02614469|B3|Baseline|Total|Total of all reporting groups
6150|NCT02614469|B2|Baseline|Group 2, Inosine Without Food Then With Food|"Group 2 subjects will take inosine without food on day 1 after an overnight fast and will take a second dose of inosine with food on day 8 after an overnight fast.
Inosine: Inosine, 1000 mg"
6151|NCT02614469|B1|Baseline|Group 1, Inosine With Food Then Without Food|"Group 1 subjects will take inosine with food on day 1 after an overnight fast and will take a second dose of inosine without food on day 8 after an overnight fast.
Inosine: Inosine, 1000 mg"
6152|NCT02614469|P2|Participant Flow|Group 2, Inosine Without Food Then With Food|"Group 2 subjects will take inosine without food on day 1 after an overnight fast and after a 7 day washout, will take a second dose of inosine with food on day 8 after an overnight fast.
Inosine: Inosine, 1000 mg"
6153|NCT02614469|P1|Participant Flow|Group 1, Inosine With Food Then Without Food|"Group 1 subjects will take inosine with food on day 1 after an overnight fast and after a 7 day washout, will take a second dose of inosine without food on day 8 after an overnight fast.
Inosine: Inosine, 1000 mg"
6154|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6155|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6156|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6160|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6161|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6162|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6163|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6164|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6165|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6166|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6167|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6168|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6169|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6170|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6171|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6172|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6173|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6174|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6175|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6176|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6177|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6178|NCT02614469|E2|Reported Event|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6179|NCT02614469|E1|Reported Event|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
6180|NCT02614222|B3|Baseline|Total|Total of all reporting groups
6181|NCT02614222|B2|Baseline|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6182|NCT02614222|B1|Baseline|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6183|NCT02614222|P2|Participant Flow|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6184|NCT02614222|P1|Participant Flow|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6185|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6186|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6187|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6188|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6189|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6190|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6191|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6299|NCT02611154|O3|Outcome|Urine Steroid Profile - Day 21|Day 21 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
6300|NCT02611154|O2|Outcome|Urine Steroid Profile - Day 13|Day 13 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
6192|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6193|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6194|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6195|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6196|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6197|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6313|NCT02609841|B2|Baseline|≥3K Dialysate Patients|Patients on ≥3K dialysate who received all 6 hemodialysis treatments over 12 days
6314|NCT02609841|B1|Baseline|<3 K Dialysate Patients|Patients on <3 K dialysate and received all 6 hemodialysis treatments over 12 days.
6315|NCT02609841|P1|Participant Flow|Enrolled Study Population|All patients who were enrolled in the study
6198|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6199|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6200|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6201|NCT02614222|E2|Reported Event|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6202|NCT02614222|E1|Reported Event|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6203|NCT02613910|B1|Baseline|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6204|NCT02613910|P1|Participant Flow|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6205|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6264|NCT02612064|B1|Baseline|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
8051|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
6206|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6207|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6316|NCT02609841|O1|Outcome|Completed the Study and Wore the Body Guardian|All subjects (<3 K dialysate or dialysate combined) who received all 6 hemodialysis treatments over 12 days and wore the Body Guardian device
6317|NCT02609841|O1|Outcome|≥3 K Dialysate Patients|Subjects on ≥3 K dialysate and received all 6 hemodialysis treatments over 12 days.
7221|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
6208|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6209|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6210|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6211|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6212|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6213|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6265|NCT02612064|P2|Participant Flow|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
6301|NCT02611154|O1|Outcome|Urine Steroid Profile - Day 6|Day 6 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
6214|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6215|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6216|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6217|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6218|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6219|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6220|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6221|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6266|NCT02612064|P1|Participant Flow|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
8052|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
6222|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6223|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6224|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6225|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6226|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6227|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6228|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6229|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6267|NCT02612064|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
6463|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
6230|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6231|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6232|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6233|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6234|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6235|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6236|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6237|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6268|NCT02612064|O1|Outcome|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
8053|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
6238|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6239|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6240|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6241|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6242|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6243|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6244|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6245|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6269|NCT02612064|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
6464|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
6246|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6247|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6248|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6249|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6250|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6251|NCT02613910|E1|Reported Event|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
6252|NCT02612077|B1|Baseline|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
6253|NCT02612077|P1|Participant Flow|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
6254|NCT02612077|O1|Outcome|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
6255|NCT02612077|O3|Outcome|Bevacizumab With 3rd Line Treatment|Patients treated with bevacizumab during third line treatment of chemotherapy
6256|NCT02612077|O2|Outcome|Bevacizumab With 2nd Line Treatment|Patients treated with bevacizumab during second line treatment of chemotherapy
6257|NCT02612077|O1|Outcome|Bevacizumab With 1st Line Treatment|Patients treated with bevacizumab during first line treatment of chemotherapy
6258|NCT02612077|O3|Outcome|Bevacizumab With 3rd Line Treatment|Patients treated with bevacizumab during third line treatment of chemotherapy
6259|NCT02612077|O2|Outcome|Bevacizumab With 2nd Line Treatment|Patients treated with bevacizumab during second line treatment of chemotherapy
6260|NCT02612077|O1|Outcome|Bevacizumab With 1st Line Treatment|Patients treated with bevacizumab during first line treatment of chemotherapy
6261|NCT02612077|E1|Reported Event|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
6262|NCT02612064|B3|Baseline|Total|Total of all reporting groups
6263|NCT02612064|B2|Baseline|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
6298|NCT02611154|O4|Outcome|Urine Steroid Profile - Day 28|Day 28 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
6270|NCT02612064|O1|Outcome|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
6271|NCT02612064|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
6272|NCT02612064|O1|Outcome|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
6273|NCT02612064|E2|Reported Event|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
6274|NCT02612064|E1|Reported Event|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
6275|NCT02611765|B3|Baseline|Total|Total of all reporting groups
6276|NCT02611765|B2|Baseline|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G
Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
6277|NCT02611765|B1|Baseline|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)
Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
6278|NCT02611765|P2|Participant Flow|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G
Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
6279|NCT02611765|P1|Participant Flow|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)
Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
6280|NCT02611765|O2|Outcome|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G
Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
6281|NCT02611765|O1|Outcome|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)
Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
6282|NCT02611765|E2|Reported Event|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G
Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
6283|NCT02611765|E1|Reported Event|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)
Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
6284|NCT02611154|B1|Baseline|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.
Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
6285|NCT02611154|P1|Participant Flow|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.
Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
6286|NCT02611154|O2|Outcome|Serum Testosterone - Day 19|Serum Testosterone at Day 19
6287|NCT02611154|O1|Outcome|Serum Testosterone - Day 0|Serum Testosterone at Day 0
6288|NCT02611154|O6|Outcome|5βAdiol|5βAdiol level will be measured in the urine sample.
6289|NCT02611154|O5|Outcome|5αAdiol|5αAdiol level will be measured in the urine sample.
6290|NCT02611154|O4|Outcome|Etiocholanolone|Etiocholanolone level will be measured in the urine sample.
6291|NCT02611154|O3|Outcome|Androsterone|Androsterone level will be measured in the urine sample.
6292|NCT02611154|O2|Outcome|Epitestosterone|Epitestosterone level will be measured in the urine sample.
6293|NCT02611154|O1|Outcome|Testosterone|Testosterone level will be measured in the urine sample.
6294|NCT02611154|O8|Outcome|Urine Steroid Profile - Day 42|Urine was collected at Day 42 to identify any suppression of endogenous testosterone production following administration.
6295|NCT02611154|O7|Outcome|Urine Steroid Profile - Day 35|Urine was collected at Day 35 to identify any suppression of endogenous testosterone production following administration.
6296|NCT02611154|O6|Outcome|Urine Steroid Profile - Day 30|Day 30 steroid level in urine. Urine sample analyzed within the 48-72 hour window post-administration.
6297|NCT02611154|O5|Outcome|Urine Steroid Profile - Day 29|Day 29 steroid level in urine. Urine sample analyzed within the 24-48 hour window post-administration.
8054|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
6302|NCT02611154|E1|Reported Event|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.
Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
6303|NCT02610634|B3|Baseline|Total|Total of all reporting groups
6304|NCT02610634|B2|Baseline|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
6305|NCT02610634|B1|Baseline|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
6306|NCT02610634|P2|Participant Flow|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
6307|NCT02610634|P1|Participant Flow|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
6308|NCT02610634|O2|Outcome|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
6309|NCT02610634|O1|Outcome|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
6310|NCT02610634|E2|Reported Event|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
6311|NCT02610634|E1|Reported Event|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
6312|NCT02609841|B3|Baseline|Total|Total of all reporting groups
6319|NCT02609841|E1|Reported Event|Cardiac Rhythm Monitoring System|Subjects use non-invasive wearable BodyGuardian remote monitoring system throughout 12 days of study.
6320|NCT02609672|B3|Baseline|Total|Total of all reporting groups
6321|NCT02609672|B2|Baseline|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6322|NCT02609672|B1|Baseline|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6323|NCT02609672|P2|Participant Flow|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee osteoarthritis, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6324|NCT02609672|P1|Participant Flow|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6325|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6376|NCT02609178|E1|Reported Event|Occlusal Surface Design|use computer-aided design and computer-aided manufacturing technique (CAD/CAM) to execute different occlusal surface designs of the artificial crown, including FGP design (FGP and AVR) and conventional design (CON), and evaluate their efficacy, separately
6377|NCT02608489|B3|Baseline|Total|Total of all reporting groups
6378|NCT02608489|B2|Baseline|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
6326|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6327|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6328|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6395|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
6396|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
6329|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6330|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6331|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6332|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6333|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6334|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6379|NCT02608489|B1|Baseline|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
6380|NCT02608489|P2|Participant Flow|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
6465|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
6335|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6336|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6346|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6337|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6338|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6339|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6340|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6341|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6342|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6343|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6381|NCT02608489|P1|Participant Flow|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
6382|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
8055|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
6344|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6345|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6347|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6348|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6349|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6350|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6351|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6352|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6383|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
6384|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
6466|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
6353|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6354|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6392|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
6393|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
6394|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
6643|NCT02596451|B2|Baseline|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
6355|NCT02609672|E2|Reported Event|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6356|NCT02609672|E1|Reported Event|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
6357|NCT02609178|B1|Baseline|Occlusal Surface Design|use computer-aided design and computer-aided manufacturing technique (CAD/CAM) to execute different occlusal surface designs of the artificial crown, including FGP design (FGP and AVR) and conventional design (CON), and evaluate their efficacy, separately
6358|NCT02609178|P6|Participant Flow|CON First, Then AVR, Then FGP|Tried in the artificial crowns for the same participant as the following sequence: CON, AVR, FGP, a 5-min washout period would be given between each crown.
6359|NCT02609178|P5|Participant Flow|CON First, Then FGP, Then AVR|Tried in the artificial crowns for the same participant as the following sequence: CON, FGP, AVR, a 5-min washout period would be given between each crown.
6360|NCT02609178|P4|Participant Flow|AVR First, Then CON, Then FGP|Tried in the artificial crowns for the same participant as the following sequence: AVR, CON, FGP, a 5-min washout period would be given between each crown.
6361|NCT02609178|P3|Participant Flow|AVR First, Then FGP, Then CON|Tried in the artificial crowns for the same participant as the following sequence: AVR, FGP, CON, a 5-min washout period would be given between each crown.
6362|NCT02609178|P2|Participant Flow|FGP First, Then CON, Then AVR|Tried in the artificial crowns for the same participant as the following sequence: FGP, CON, AVR, a 5-min washout period would be given between each crown.
6363|NCT02609178|P1|Participant Flow|FGP First, Then AVR, Then CON|Tried in the artificial crowns for the same participant as the following sequence: FGP, AVR, CON, a 5-min washout period would be given between each crown.
6364|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
6365|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
6366|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
6367|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
6368|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
6369|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
6370|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
6371|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
6372|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
6373|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
6374|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
6375|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
6458|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
6385|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
6386|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
6387|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
6388|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
6389|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
6390|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
6391|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
6644|NCT02596451|B1|Baseline|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
6397|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
6398|NCT02608489|E2|Reported Event|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
6399|NCT02608489|E1|Reported Event|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
6400|NCT02606838|B1|Baseline|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.
Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
6401|NCT02606838|P1|Participant Flow|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.
Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
6402|NCT02606838|O1|Outcome|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.
Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
6403|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain AST palm capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
6404|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain fingerstick capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
6405|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain AST palm capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
6406|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain fingerstick capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
6407|NCT02606838|E1|Reported Event|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.
Styx Lancing Device System: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
6408|NCT02606734|B1|Baseline|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.
Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
6409|NCT02606734|P1|Participant Flow|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.
Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
6459|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
6410|NCT02606734|O1|Outcome|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.
Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
6411|NCT02606734|E1|Reported Event|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.
Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
6412|NCT02605928|B1|Baseline|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.
Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
6413|NCT02605928|P1|Participant Flow|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.
Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
6435|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
6645|NCT02596451|P3|Participant Flow|Placebo|Vehicle gel (Glenmark Pharmaceuticals Ltd)
6414|NCT02605928|O1|Outcome|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.
Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
6415|NCT02605928|E1|Reported Event|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.
Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
6416|NCT02604589|B4|Baseline|Total|Total of all reporting groups
6417|NCT02604589|B3|Baseline|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
6418|NCT02604589|B2|Baseline|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
6419|NCT02604589|B1|Baseline|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
6420|NCT02604589|P3|Participant Flow|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
6421|NCT02604589|P2|Participant Flow|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
6422|NCT02604589|P1|Participant Flow|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
6423|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
6424|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
6425|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
6426|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
6427|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
6428|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
6460|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
8056|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
6429|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
6430|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
6431|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
6432|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
6433|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
6434|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
6436|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
6437|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
6438|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
6439|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
6440|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
6441|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
6442|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
6443|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
6444|NCT02604589|E3|Reported Event|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
6445|NCT02604589|E2|Reported Event|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
6446|NCT02604589|E1|Reported Event|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
6447|NCT02604550|B3|Baseline|Total|Total of all reporting groups
6448|NCT02604550|B2|Baseline|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
6449|NCT02604550|B1|Baseline|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
6450|NCT02604550|P2|Participant Flow|Adductor Canal Block|Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the adductor canal
6451|NCT02604550|P1|Participant Flow|Femoral Nerve Block|Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the femoral nerve.
6452|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
6453|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
6454|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
6455|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
6456|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
6457|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
8057|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
6467|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
6468|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
6469|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
6470|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
6471|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
6472|NCT02604550|E2|Reported Event|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
6473|NCT02604550|E1|Reported Event|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
6474|NCT02604407|B4|Baseline|Total|Total of all reporting groups
6475|NCT02604407|B3|Baseline|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
6476|NCT02604407|B2|Baseline|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
6477|NCT02604407|B1|Baseline|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
6478|NCT02604407|P3|Participant Flow|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
6479|NCT02604407|P2|Participant Flow|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 milligram (mg) orally once daily for 4 weeks.
6480|NCT02604407|P1|Participant Flow|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
6646|NCT02596451|P2|Participant Flow|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
6481|NCT02604407|O3|Outcome|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
6482|NCT02604407|O2|Outcome|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
6483|NCT02604407|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
6484|NCT02604407|O3|Outcome|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
6485|NCT02604407|O2|Outcome|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
6486|NCT02604407|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
6487|NCT02604407|E3|Reported Event|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
6488|NCT02604407|E2|Reported Event|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 milligram (mg) orally once daily for 4 weeks.
6489|NCT02604407|E1|Reported Event|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
6490|NCT02604264|B3|Baseline|Total|Total of all reporting groups
6491|NCT02604264|B2|Baseline|Control|Standard hemodialysis end cap
6492|NCT02604264|B1|Baseline|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
6493|NCT02604264|P2|Participant Flow|Control|Standard hemodialysis end cap
6494|NCT02604264|P1|Participant Flow|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
6495|NCT02604264|O2|Outcome|Control|Standard hemodialysis end cap
6496|NCT02604264|O1|Outcome|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
6497|NCT02604264|E2|Reported Event|Control|Standard hemodialysis end cap
6498|NCT02604264|E1|Reported Event|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
6499|NCT02603666|B1|Baseline|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.
Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
6500|NCT02603666|P1|Participant Flow|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.
Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
6501|NCT02603666|O1|Outcome|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.
Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
6502|NCT02603666|E1|Reported Event|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.
Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
6503|NCT02602223|B1|Baseline|Amnion Chorion Membrane & d-PTFE|"Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.
Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed."
6523|NCT02598934|P1|Participant Flow|Ibandronate (Consult Group)|Participants received ibandronate 150-milligram (mg) tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on bone turnover marker (BTM) response.
6524|NCT02598934|O2|Outcome|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
8058|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
6504|NCT02602223|P1|Participant Flow|Amnion Chorion Membrane & d-PTFE|"Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.
Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed."
6505|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side
Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6647|NCT02596451|P1|Participant Flow|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
6648|NCT02596451|O2|Outcome|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
6506|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.
Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6507|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side
Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6508|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.
Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6509|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side
Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6510|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.
Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6511|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side
Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6512|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.
Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6513|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side
Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6649|NCT02596451|O1|Outcome|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
6514|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.
Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6515|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side
Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6516|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.
Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6517|NCT02602223|E2|Reported Event|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side
Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6518|NCT02602223|E1|Reported Event|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.
Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
6519|NCT02598934|B3|Baseline|Total|Total of all reporting groups
6520|NCT02598934|B2|Baseline|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
6521|NCT02598934|B1|Baseline|Ibandronate (Consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response.
6522|NCT02598934|P2|Participant Flow|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
8059|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
6525|NCT02598934|O1|Outcome|Ibandronate (Consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response.
6526|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.
Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
6527|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.
Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
6528|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.
Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
6529|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.
Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
6650|NCT02596451|E3|Reported Event|Placebo|Vehicle gel (Glenmark Pharmaceuticals Ltd)
6651|NCT02596451|E2|Reported Event|Reference|Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
6530|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.
Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
6531|NCT02598934|E1|Reported Event|Ibandronate (All Participants)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months. Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
6532|NCT02598622|B3|Baseline|Total|Total of all reporting groups
6533|NCT02598622|B2|Baseline|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
Placebo: Placebo is taken 2 times a day for days 1 through 21."
6534|NCT02598622|B1|Baseline|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
6535|NCT02598622|P2|Participant Flow|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
Placebo: Placebo is taken 2 times a day for days 1 through 21."
6536|NCT02598622|P1|Participant Flow|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
6537|NCT02598622|O2|Outcome|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
Placebo: Placebo is taken 2 times a day for days 1 through 21."
6538|NCT02598622|O1|Outcome|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
6539|NCT02598622|E2|Reported Event|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
Placebo: Placebo is taken 2 times a day for days 1 through 21."
6540|NCT02598622|E1|Reported Event|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
6541|NCT02598128|B1|Baseline|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
6542|NCT02598128|P4|Participant Flow|Period C: Clinical Treatment Practice + RELiZORB (Days 12-20)|Period C was the open label clinical treatment period with RELiZORB. All patients used RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
6543|NCT02598128|P3|Participant Flow|Crossover Period B: RELiZORB Then Placebo|Eligible subjects were randomized to RELiZORB then Placebo.
6544|NCT02598128|P2|Participant Flow|Crossover Period B: Placebo Then RELiZORB|Eligible subjects were randomized to Placebo then RELiZORB.
6545|NCT02598128|P1|Participant Flow|Period A: Clinical Treatment Practice (Days -7 to -1)|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
6546|NCT02598128|O1|Outcome|Clinical Treatment Practice and Relizorb: Period C: Days 12-20|Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
6547|NCT02598128|O2|Outcome|Control|Subjects receiving placebo at any time in the study.
6548|NCT02598128|O1|Outcome|RELiZORB|Subjects receiving RELiZORB at any time in the study.
8060|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
6549|NCT02598128|O4|Outcome|Clinical Treatment Practice + RELiZORB: Period C: Days 12-20|Non-gastrointestinal adverse events during CTP+RELiZORB administration.
6550|NCT02598128|O3|Outcome|Crossover Period B: RELiZORB|Non-gastrointestinal adverse events during administration.
6551|NCT02598128|O2|Outcome|Crossover Period B: Placebo|Non-gastrointestinal adverse events during administration.
6552|NCT02598128|O1|Outcome|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
6553|NCT02598128|E3|Reported Event|Clinical Treatment Practice and Relizorb: Period C: Days 12-20|Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
6554|NCT02598128|E2|Reported Event|Double-Blind Crossover: Period B: Days 1 to 11|Period B was the randomized, double-blind, placebo-controlled crossover period. Eligible patients were randomized in a 1:1 ratio to either Placebo-RELiZORB or RELiZORB-Placebo treatment sequences. On two separate administration Days 1 and 9, patients received 500 mL of Impact Peptide1.5 in clinic over a 4h period. Motility and acid suppression medications were discontinued 24h before arrival in clinic. No nocturnal feeding occurred between Days 1-2 and Days 9-10. During the home washout period Days 2 to 8, patients received Peptamen 1.5 for enteral nutrition up to a maximum volume of 1000 mL per feeding. Safety follow up calls were conducted on Days 2 and 10.
6555|NCT02598128|E1|Reported Event|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
6556|NCT02597907|B3|Baseline|Total|Total of all reporting groups
6557|NCT02597907|B2|Baseline|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg
aprepitant: aprepitant 80 mg is given to all patients before surgery
Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
6558|NCT02597907|B1|Baseline|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg
aprepitant: aprepitant 80 mg is given to all patients before surgery
palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
6559|NCT02597907|P2|Participant Flow|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg
aprepitant: aprepitant 80 mg is given to all patients before surgery
palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
6560|NCT02597907|P1|Participant Flow|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg
aprepitant: aprepitant 80 mg is given to all patients before surgery
Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
6561|NCT02597907|O2|Outcome|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg
aprepitant: aprepitant 80 mg is given to all patients before surgery
Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
6562|NCT02597907|O1|Outcome|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg
aprepitant: aprepitant 80 mg is given to all patients before surgery
palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
6563|NCT02597907|E2|Reported Event|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg
aprepitant: aprepitant 80 mg is given to all patients before surgery
Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
6564|NCT02597907|E1|Reported Event|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg
aprepitant: aprepitant 80 mg is given to all patients before surgery
palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
6565|NCT02597855|B3|Baseline|Total|Total of all reporting groups
6566|NCT02597855|B2|Baseline|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
6567|NCT02597855|B1|Baseline|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
6568|NCT02597855|P2|Participant Flow|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.
Aflibercept: Total 4 times of intravitreal aflibercept injection was performed
Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
6569|NCT02597855|P1|Participant Flow|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.
Aflibercept: Total 4 times of intravitreal aflibercept injection was performed
Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
6570|NCT02597855|O2|Outcome|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
6571|NCT02597855|O1|Outcome|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
6572|NCT02597855|O2|Outcome|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
6573|NCT02597855|O1|Outcome|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
6652|NCT02596451|E1|Reported Event|Test|Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
6574|NCT02597855|E2|Reported Event|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
6575|NCT02597855|E1|Reported Event|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
6576|NCT02597582|B3|Baseline|Total|Total of all reporting groups
6577|NCT02597582|B2|Baseline|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
6578|NCT02597582|B1|Baseline|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.
Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
6579|NCT02597582|P2|Participant Flow|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
6580|NCT02597582|P1|Participant Flow|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.
Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
6581|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
6582|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.
Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
6583|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
6584|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.
Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
6585|NCT02597582|O2|Outcome|Conventional Neck Dissection|"The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.
Neck dissection: The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
6586|NCT02597582|O1|Outcome|Ligusure Assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.
Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.
Neck dissection: The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
6587|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
6619|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
6588|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.
Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
6589|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
6590|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.
Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
6591|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
7962|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
6592|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.
Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
6593|NCT02597582|E2|Reported Event|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
6594|NCT02597582|E1|Reported Event|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.
Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
6595|NCT02597543|B3|Baseline|Total|Total of all reporting groups
6596|NCT02597543|B2|Baseline|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6597|NCT02597543|B1|Baseline|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6598|NCT02597543|P2|Participant Flow|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6599|NCT02597543|P1|Participant Flow|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6600|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6601|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6602|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6603|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6670|NCT02594826|P1|Participant Flow|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.
Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
6604|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6605|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6623|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
6606|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6607|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6608|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6609|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6610|NCT02597543|O2|Outcome|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6611|NCT02597543|O1|Outcome|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6612|NCT02597543|E2|Reported Event|Normal Graft Function|"Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6613|NCT02597543|E1|Reported Event|Nonspecific Allograft Dysfunction|"Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart.
Regadenoson: For use in stress myocardial perfusion imaging.
Gadolinium: For use in both perfusion imaging and late gadolinium enhancement.
Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart."
6614|NCT02596958|B1|Baseline|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
6615|NCT02596958|P1|Participant Flow|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current summary of product characteristics (SmPC).
6616|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
6617|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
6618|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
8061|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
6620|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
6621|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
6622|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
6624|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
6625|NCT02596958|E1|Reported Event|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
6626|NCT02596945|B1|Baseline|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
6627|NCT02596945|P1|Participant Flow|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC) were observed for a period of 9 months.
6628|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
6629|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
6630|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
6631|NCT02596945|E1|Reported Event|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
6632|NCT02596620|B3|Baseline|Total|Total of all reporting groups
6633|NCT02596620|B2|Baseline|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days
Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms
Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm
Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
6634|NCT02596620|B1|Baseline|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days
Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms
Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm
Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm
Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
6635|NCT02596620|P2|Participant Flow|Triple Therapy|levofloxacin 500 mg qd, amoxicillin 1 g bid, and esomeprazole 40 mg bid
6636|NCT02596620|P1|Participant Flow|Sequential Therapy|esomeprazole 40 mg bid and amoxicillin 1 g bid for 5 days, followed by esomeprazole 40 mg bid, levofloxacin 500 mg qd, and metronidazole 500 mg tid, for 5 days
6637|NCT02596620|O2|Outcome|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days
Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms
Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm
Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
6638|NCT02596620|O1|Outcome|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days
Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms
Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm
Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm
Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
6695|NCT02591238|B2|Baseline|IIInon-smoker + Melatonin|"non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6639|NCT02596620|E2|Reported Event|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days
Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms
Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm
Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
6640|NCT02596620|E1|Reported Event|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days
Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms
Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm
Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm
Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
6653|NCT02595502|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the duration of the study.
6654|NCT02595502|P2|Participant Flow|Senofilcon A/Delefilcon A/Senofilcon A|Subjects that wore the senofilcon A lens first, the delefilcon A lens second and then wore the senofilcon A lens again, third.
6655|NCT02595502|P1|Participant Flow|Delefilcon A /Senofilcon A/Delefilcon A|Subjects that wore the delefilcon A lens first, the senofilcon A lens second and then wore the delefilcon A lens again, third.
6656|NCT02595502|O2|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.
6657|NCT02595502|O1|Outcome|Delefilcon A|Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.
6658|NCT02595502|E2|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.
6659|NCT02595502|E1|Reported Event|Delefilcon A|Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.
6660|NCT02595450|B1|Baseline|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
6661|NCT02595450|P1|Participant Flow|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
6662|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
6663|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
6664|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
6665|NCT02595450|E1|Reported Event|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
6666|NCT02594826|B3|Baseline|Total|Total of all reporting groups
6667|NCT02594826|B2|Baseline|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.
General health education control: General health and cancer education"
6668|NCT02594826|B1|Baseline|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.
Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
6669|NCT02594826|P2|Participant Flow|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.
General health education control: General health and cancer education"
8062|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
6671|NCT02594826|O2|Outcome|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.
General health education control: General health and cancer education"
6672|NCT02594826|O1|Outcome|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.
Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
6673|NCT02594826|E2|Reported Event|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.
General health education control: General health and cancer education"
6674|NCT02594826|E1|Reported Event|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.
Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
6675|NCT02592655|B3|Baseline|Total|Total of all reporting groups
6676|NCT02592655|B2|Baseline|Two Windlass Tourniquets|Baseline characteristics for participants who had a second windlass tourniquet applied immediately proximal to the first. Meaning that a single windlass tourniquet did not appear effective.
6677|NCT02592655|B1|Baseline|One Windlass Tourniquet|Baseline characteristics for participants that received only one windlass tourniquet.
6678|NCT02592655|P1|Participant Flow|All Participants|"Each subject has been randomly allocated to a sequence of interventions. Pneumatic tourniquet with a 10 cm (4 inch) wide cylindrical cuff typically used in surgical settings, and is representative of best outcome.
Windlass Tourniquet: The Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) is 3.8 cm (1.5 inch) in width. The SOFTT-W is representative of the typical emergency tourniquet. In accordance with current prehospital guidelines: If a single windlass tourniquet not effective then a second windlass tourniquet will be applied immediately proximal to the first.
Tourniquet Tape 10 cm wide and Tourniquet Tape 5 cm wide are elastic adhesive tape tourniquets.
5 cm tape was discontinued after the 4th participant. Once stretched the tape was too narrow for sufficient overlap. Because the overlap was not sufficient the edges began to roll. This would create an unacceptably narrow band if left in place longer than the prescribed time."
6679|NCT02592655|O5|Outcome|Tourniquet Tape 5 cm|Tourniquet Tape 5 cm (2 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
6680|NCT02592655|O4|Outcome|Two Windlass Tourniquets|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of the two windlass tourniquets to the middle upper thigh. If no flow is observed by the investigators for 1 sustained minute then it is considered successful occlusion.
6681|NCT02592655|O3|Outcome|One Windlass Tourniquet|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of one windlass tourniquet to the middle upper thigh. If no flow is observed by the investigators for 1 sustained minute then it is considered successful occlusion.
6682|NCT02592655|O2|Outcome|Pneumatic Tourniquet|Automatic pneumatic tourniquet with a 10 cm (4 inch) wide cuff applied to the upper half of the participants thigh. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
6683|NCT02592655|O1|Outcome|Tourniquet Tape 10 cm|Tourniquet Tape 10 cm (4 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful.
6684|NCT02592655|O4|Outcome|Two Windlass Tourniquets|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of two windlass tourniquets to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
6685|NCT02592655|O3|Outcome|One Windlass Tourniquet|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a one windlass tourniquet to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.
6686|NCT02592655|O2|Outcome|Pneumatic Tourniquet|Automatic pneumatic tourniquet with a 10 cm (4 inch) wide cuff applied to the upper half of the participants thigh. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.
6687|NCT02592655|O1|Outcome|Tourniquet Tape 10 cm|Tourniquet Tape 10 cm (4 inch) width. Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the tourniquet tape application. If no flow is observed for 1 sustained minute then the occlusion is considered successful. A still image is then saved for later evaluation by the blinded outcome assessor.
6688|NCT02592655|E4|Reported Event|Tourniquet Tape 10 cm|Tourniquet Tape, 10 cm (4 inch) width. A highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb.
6689|NCT02592655|E3|Reported Event|Tourniquet Tape 5 cm|Tourniquet Tape 5 cm (2 inch) width. A highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb.
6690|NCT02592655|E2|Reported Event|Windlass Tourniquet|One or two windlass tourniquets applied as needed to achieve study objectives.
6691|NCT02592655|E1|Reported Event|Pneumatic Tourniquet|The Automatic Tourniquet System (ATS) 1500 by Zimmer (formerly Aspen Labs) was used with a 10 cm (4 inch) wide pneumatic cuff.
6692|NCT02591238|B5|Baseline|Total|Total of all reporting groups
6693|NCT02591238|B4|Baseline|Ismoker + Melatonin|"smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6694|NCT02591238|B3|Baseline|IIsmoker + Placebo|"smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks."
6843|NCT02587117|P2|Participant Flow|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
6696|NCT02591238|B1|Baseline|IVnon-smoker + Placebo|"non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks."
6697|NCT02591238|P4|Participant Flow|I Smoker + Melatonin|"smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6698|NCT02591238|P3|Participant Flow|II Smoker + Placebo|"smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks."
6699|NCT02591238|P2|Participant Flow|III Non-smoker + Melatonin|"non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6700|NCT02591238|P1|Participant Flow|IV Non-smoker + Placebo|"non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks."
6701|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6702|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks."
6703|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6704|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks."
6705|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6706|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks."
6707|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6708|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks."
6709|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6710|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks."
6711|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6712|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks."
6713|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6714|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks."
6715|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6716|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks."
6717|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6718|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks."
6719|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6720|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks."
6721|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6722|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks."
6723|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6724|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks."
6725|NCT02591238|E4|Reported Event|Smoker + Melatonin|"smoker oral melatonin
smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6726|NCT02591238|E3|Reported Event|Smoker + Placebo|"smoker oral placebo
smoker oral placebo: Participants oral placebo last 2 weeks."
6727|NCT02591238|E2|Reported Event|Non-smoker + Melatonin|"non-smoker oral melatonin
non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
6728|NCT02591238|E1|Reported Event|Non-smoker + Placebo|"non-smoker oral placebo
non-smoker oral placebo: Participants oral placebo last 2 weeks."
6729|NCT02591056|B1|Baseline|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.
Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
6730|NCT02591056|P1|Participant Flow|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.
Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
6731|NCT02591056|O1|Outcome|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.
Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
6732|NCT02591056|E1|Reported Event|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.
Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
6733|NCT02590588|B1|Baseline|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.
Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
6734|NCT02590588|P1|Participant Flow|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.
Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
6735|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.
Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
6736|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.
Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
6737|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.
Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
6738|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.
Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
6739|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.
Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
6740|NCT02590588|E1|Reported Event|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.
Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
7222|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
6741|NCT02590562|B1|Baseline|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6742|NCT02590562|P1|Participant Flow|Overall Population|Participants diagnosed with rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) 1987 criteria who were using biological disease-modifying anti-rheumatic drugs (DMARDs) approved in China for RA treatment were observed at the single study visit (enrollment visit).
6743|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6744|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6745|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6746|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6747|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6748|NCT02590562|O2|Outcome|Biological Agent as Combination With csDMARDs|Participants were divided into two groups according to whether using biological agent (namely, biological agent concomitant with csDMARDs treatment group and biological agent without csDMARDs treatment group). This group included participants using biological agent with concomitant csDMARDs.
6749|NCT02590562|O1|Outcome|Biological Agent as Monotherapy|Participants were divided into two groups according to whether using biological agent (namely, biological agent concomitant with csDMARDs treatment group and biological agent without csDMARDs treatment group). This group included participants using biological agent without concomitant csDMARDs.
6750|NCT02590562|O4|Outcome|Duration of Biological Treatment >=12 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=12 months.
6751|NCT02590562|O3|Outcome|Duration of Biological Treatment >=6 to <12 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=6 to <12 months.
6752|NCT02590562|O2|Outcome|Duration of Biological Treatment >=3 to <6 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=3 to <6 months.
6753|NCT02590562|O1|Outcome|Duration of Biological Treatment <3 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment <3 months.
6754|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6755|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6756|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6844|NCT02587117|P1|Participant Flow|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
6757|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6758|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6759|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6760|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6761|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6762|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6763|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6764|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6765|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6766|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6767|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6768|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6769|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6770|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6771|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6772|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6773|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6774|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6775|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6776|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6777|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6778|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6779|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6780|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6781|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6782|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6783|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6784|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6785|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
7135|NCT02576639|O1|Outcome|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
6786|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6787|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6788|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6789|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6790|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6791|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6792|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6793|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6794|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6795|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6796|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6797|NCT02590562|E1|Reported Event|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
6798|NCT02588872|B3|Baseline|Total|Total of all reporting groups
6799|NCT02588872|B2|Baseline|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.
Platelet-rich Plasma (PRP)"
6800|NCT02588872|B1|Baseline|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.
Hyaluronic Acid"
6801|NCT02588872|P2|Participant Flow|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.
Platelet-rich Plasma (PRP)"
6802|NCT02588872|P1|Participant Flow|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.
Hyaluronic Acid"
6803|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.
Platelet-rich Plasma (PRP)"
6804|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.
Hyaluronic Acid"
6805|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.
Platelet-rich Plasma (PRP)"
6806|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.
Hyaluronic Acid"
6807|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.
Platelet-rich Plasma (PRP)"
6808|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.
Hyaluronic Acid"
6809|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.
Platelet-rich Plasma (PRP)"
6810|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.
Hyaluronic Acid"
6923|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
6811|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.
Platelet-rich Plasma (PRP)"
6812|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.
Hyaluronic Acid"
6813|NCT02588872|E2|Reported Event|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.
Platelet-rich Plasma (PRP)"
6814|NCT02588872|E1|Reported Event|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.
Hyaluronic Acid"
6815|NCT02588599|B1|Baseline|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
6816|NCT02588599|P1|Participant Flow|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
6817|NCT02588599|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
6818|NCT02588599|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
6819|NCT02588599|E1|Reported Event|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
6820|NCT02587819|B1|Baseline|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
7223|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
6821|NCT02587819|P1|Participant Flow|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
6822|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
6823|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
6824|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
6825|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days post baseline to all subjects. All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments at 57 days post-Baseline.
6826|NCT02587819|E1|Reported Event|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
6827|NCT02587234|B3|Baseline|Total|Total of all reporting groups
6828|NCT02587234|B2|Baseline|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6829|NCT02587234|B1|Baseline|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6830|NCT02587234|P2|Participant Flow|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6831|NCT02587234|P1|Participant Flow|Active|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6832|NCT02587234|O2|Outcome|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6833|NCT02587234|O1|Outcome|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6834|NCT02587234|O2|Outcome|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6835|NCT02587234|O1|Outcome|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6836|NCT02587234|O2|Outcome|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6837|NCT02587234|O1|Outcome|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6838|NCT02587234|E2|Reported Event|Sham PNS|"2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6839|NCT02587234|E1|Reported Event|Active PNS|"2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves"
6840|NCT02587117|B3|Baseline|Total|Total of all reporting groups
6841|NCT02587117|B2|Baseline|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
6842|NCT02587117|B1|Baseline|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
7136|NCT02576639|E5|Reported Event|CNP520 85mg|CNP520 85 mg was taken qd orally for 13 weeks.
6845|NCT02587117|O2|Outcome|Prednisolone Group|"Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
Prednisolone: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
6846|NCT02587117|O1|Outcome|Lycopene Group|"Lycopene- 4 mg capsule by mouth single dose per day for 2 months
lycopene: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
6847|NCT02587117|O2|Outcome|Prednisolone Group|"Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
Prednisolone: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
6848|NCT02587117|O1|Outcome|Lycopene Group|"Lycopene- 4 mg capsule by mouth single dose per day for 2 months
lycopene: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
6849|NCT02587117|E2|Reported Event|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
6850|NCT02587117|E1|Reported Event|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
6851|NCT02586506|B1|Baseline|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
6932|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
7963|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
6852|NCT02586506|P1|Participant Flow|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
6853|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
6854|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
6855|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
6856|NCT02586506|E1|Reported Event|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
6857|NCT02586493|B1|Baseline|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
6858|NCT02586493|P1|Participant Flow|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
6859|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
6860|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
6861|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
6862|NCT02586493|E1|Reported Event|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
6863|NCT02585999|B1|Baseline|Xulane|"Participants exposed to contraceptive patch, Xulane.
Xulane Contraceptive Patch (generic version of Ortho Evra®*): Extended use (12 Weeks) of Contraceptive Patch"
6864|NCT02585999|P1|Participant Flow|Xulane|"Participants exposed to contraceptive patch, Xulane.
Xulane Contraceptive Patch (generic version of Ortho Evra®*): Extended use (12 Weeks) of Contraceptive Patch"
6865|NCT02585999|O1|Outcome|Xulane|"All participants using the Xulane contraceptive patch for 12 continuous weeks
Xulane Contraceptive Patch: Extended use (12 weeks) of contraceptive patch"
6866|NCT02585999|O1|Outcome|Xulane|Participants exposed to Xulane Contraceptive Patch for 12 weeks of continuous use
6867|NCT02585999|E1|Reported Event|Xulane|All participants using the Xulane contraceptive patch for 12 continuous weeks
6868|NCT02584686|B3|Baseline|Total|Total of all reporting groups
6869|NCT02584686|B2|Baseline|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6933|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
7224|NCT02575911|E2|Reported Event|LenSx|All subjects treated with LASIK surgery in both eyes using LenSx® Femtosecond Laser System
6870|NCT02584686|B1|Baseline|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6871|NCT02584686|P2|Participant Flow|Control Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6872|NCT02584686|P1|Participant Flow|Study Group|"The treatment group, 12 patients will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6873|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6874|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6875|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6876|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6877|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6878|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6879|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6880|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6881|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6963|NCT02580799|E1|Reported Event|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6882|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6883|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6884|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6885|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
7213|NCT02575911|O3|Outcome|LenSx - Month 3 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
6886|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6887|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6888|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6889|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6890|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6891|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6892|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6893|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6894|NCT02584686|O1|Outcome|(BTX) A|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6895|NCT02584686|E2|Reported Event|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
6896|NCT02584686|E1|Reported Event|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
6897|NCT02584673|B3|Baseline|Total|Total of all reporting groups
6898|NCT02584673|B2|Baseline|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6924|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
6925|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
6899|NCT02584673|B1|Baseline|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6900|NCT02584673|P2|Participant Flow|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6901|NCT02584673|P1|Participant Flow|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6902|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
7214|NCT02575911|O2|Outcome|LenSx - Month 1 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
7215|NCT02575911|O1|Outcome|Baseline|Prior to LASIK surgery
6903|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6904|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6905|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6906|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6907|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6908|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6909|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6910|NCT02584673|E2|Reported Event|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
6911|NCT02584673|E1|Reported Event|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
6912|NCT02582983|B1|Baseline|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
6913|NCT02582983|P1|Participant Flow|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
6914|NCT02582983|O1|Outcome|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
6915|NCT02582983|O1|Outcome|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
6916|NCT02582983|E1|Reported Event|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
6917|NCT02582970|B1|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
6918|NCT02582970|P1|Participant Flow|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks (q2w) in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
6919|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
6920|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
6921|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
6922|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
6926|NCT02582970|E1|Reported Event|Bevacizumab + Chemotherapy|Participants received IV bevacizumab at a dose of 5 mg/kg q2w in combination with standard of care chemotherapy regimen until disease progression or until termination of the study.
6927|NCT02581475|B3|Baseline|Total|Total of all reporting groups
6928|NCT02581475|B2|Baseline|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
6929|NCT02581475|B1|Baseline|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
6930|NCT02581475|P2|Participant Flow|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
6931|NCT02581475|P1|Participant Flow|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
7964|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
6934|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
6935|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
6936|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
6937|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
6938|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
6939|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
6940|NCT02581475|E2|Reported Event|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
6941|NCT02581475|E1|Reported Event|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
6942|NCT02580799|B1|Baseline|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6943|NCT02580799|P1|Participant Flow|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6944|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6945|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6946|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6947|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6948|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6949|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6950|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6951|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6952|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6953|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6954|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6955|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6956|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6957|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6958|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6959|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6960|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6961|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6962|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
6964|NCT02580357|B4|Baseline|Total|Total of all reporting groups
6965|NCT02580357|B3|Baseline|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6973|NCT02580357|O1|Outcome|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
7344|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)
Normal saline: Intravenous normal saline 0.9% 5 mL"
6966|NCT02580357|B2|Baseline|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6967|NCT02580357|B1|Baseline|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6968|NCT02580357|P3|Participant Flow|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6969|NCT02580357|P2|Participant Flow|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6970|NCT02580357|P1|Participant Flow|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6971|NCT02580357|O3|Outcome|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6981|NCT02580240|B2|Baseline|Hydrocortisone|Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
6982|NCT02580240|B1|Baseline|Placebo|Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
6983|NCT02580240|P2|Participant Flow|Hydrocortisone|Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
8063|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
6972|NCT02580357|O2|Outcome|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6974|NCT02580357|O3|Outcome|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6975|NCT02580357|O2|Outcome|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6976|NCT02580357|O1|Outcome|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6977|NCT02580357|E3|Reported Event|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6978|NCT02580357|E2|Reported Event|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6979|NCT02580357|E1|Reported Event|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
6980|NCT02580240|B3|Baseline|Total|Total of all reporting groups
6984|NCT02580240|P1|Participant Flow|Placebo|Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
6985|NCT02580240|O2|Outcome|Hydrocortisone|"Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
Hydrocortisone: Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped)."
6986|NCT02580240|O1|Outcome|Placebo|"Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
saline: Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar."
6987|NCT02580240|O2|Outcome|Hydrocortisone|"Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
Hydrocortisone: Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped)."
7216|NCT02575911|O2|Outcome|LenSx - Month 3 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
6988|NCT02580240|O1|Outcome|Placebo|"Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
saline: Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar."
6989|NCT02580240|E2|Reported Event|Hydrocortisone|Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
6990|NCT02580240|E1|Reported Event|Placebo|Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
6991|NCT02578992|B3|Baseline|Total|Total of all reporting groups
6992|NCT02578992|B2|Baseline|Neutral Position|The patients’ head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique
6993|NCT02578992|B1|Baseline|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique
Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.
7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
6994|NCT02578992|P2|Participant Flow|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
6995|NCT02578992|P1|Participant Flow|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.
7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
6996|NCT02578992|O2|Outcome|Head-lift Position|All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit
6997|NCT02578992|O1|Outcome|Neutral Head Position|All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit
6998|NCT02578992|O2|Outcome|Head-lift Position|Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.
6999|NCT02578992|O1|Outcome|Neutral Head Position|Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.
7000|NCT02578992|O2|Outcome|Head-lift Position|The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.
7001|NCT02578992|O1|Outcome|Neutral Head Position|The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.
7002|NCT02578992|O2|Outcome|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
7003|NCT02578992|O1|Outcome|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.
7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
7004|NCT02578992|E2|Reported Event|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
7049|NCT02577445|O1|Outcome|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
7005|NCT02578992|E1|Reported Event|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.
7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
7053|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
7054|NCT02577445|E2|Reported Event|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
7073|NCT02577315|E2|Reported Event|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7006|NCT02578316|B1|Baseline|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for pharmacokinetic (PK) analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7007|NCT02578316|P1|Participant Flow|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity"
7008|NCT02578316|O1|Outcome|14C^Lenvatinib/Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7009|NCT02578316|O1|Outcome|14C^Lenvatinib/Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7010|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7011|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7012|NCT02578316|O1|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7137|NCT02576639|E4|Reported Event|CNP520 35mg|CNP520 35 mg was taken qd orally for 13 weeks.
7055|NCT02577445|E1|Reported Event|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
7056|NCT02577315|B3|Baseline|Total|Total of all reporting groups
7217|NCT02575911|O1|Outcome|LenSx - Month 1 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
7218|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
7013|NCT02578316|O1|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7014|NCT02578316|O1|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7015|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7016|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7017|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7018|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7019|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7020|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7021|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7022|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7023|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7024|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7025|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7026|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7027|NCT02578316|O2|Outcome|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for pharmacokinetic (PK) analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7050|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
7051|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
7052|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
7138|NCT02576639|E3|Reported Event|CNP520 10mg|CNP520 10 mg was taken qd orally for 13 weeks.
7028|NCT02578316|O1|Outcome|14^C-Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for PK analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity."
7029|NCT02578316|E1|Reported Event|Lenvatinib|"Study Phase: Participants received a single dose of an oral dosing solution of 14^C-labeled lenvatinib (approximately 100 μCi or 3.7 MBq) and approximately 24 mg non-radiolabeled lenvatinib on Day 1. From Days 1 to 8, participants remained in the research unit so blood, urine, and fecal samples could be collected for pharmacokinetic (PK) analysis and determination of 14^C-lenvatinib concentrations prior to, and for 7 days following, drug administration. Participants were discharged after the checkout procedures were completed on Day 8, or when the level of radiation in urine and fecal samples was less than 1% of the total radioactive dose.
Extension Phase: Participants received 24 mg oral lenvatinib once daily at home or at the clinic on Visit Days 1, 8, 15, and 22 of each treatment cycle (1 treatment cycle = 28 days) until discontinuation from the study. The dose of lenvatinib could be reduced or discontinued during any cycle because of toxicity"
7030|NCT02578199|B1|Baseline|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.
motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
7031|NCT02578199|P1|Participant Flow|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.
motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
7032|NCT02578199|O1|Outcome|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.
motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
7033|NCT02578199|O1|Outcome|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.
motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
7034|NCT02578199|E1|Reported Event|Motivational Interviewing and Nutrition|"Motivational interviewing and nutritional counseling.
motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling"
7035|NCT02578186|B1|Baseline|Entire Study Population|Entire Study Population Includes groups that received Placebo and Drug First
7036|NCT02578186|P2|Participant Flow|Placebo, Then Diphenhydramine Hydrochloride|"Placebo elixir taken when subjects had trouble falling asleep
Placebo: Placebo once a day at bedtime in first intervention period and DPH (50 mg) once a day at bedtime for the second intervention period (after 5 day washout period)."
7037|NCT02578186|P1|Participant Flow|Diphenhydramine Hydrochloride, Then Placebo|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep
Diphenhydramine Hydrochloride: DPH (50 mg) once a day at bedtime in first intervention period and Placebo once a day at bedtime for the second intervention period (after 5 day washout period)."
7038|NCT02578186|O2|Outcome|Placebo|"Placebo elixir taken when subjects had trouble falling asleep
Placebo: 30 mL at bedtime"
7039|NCT02578186|O1|Outcome|Diphenhydramine Hydrochloride|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep
Diphenhydramine Hydrochloride: 30 mL at bedtime"
7040|NCT02578186|E2|Reported Event|Placebo|"Placebo elixir taken when subjects had trouble falling asleep
Placebo: 30 mL at bedtime"
7041|NCT02578186|E1|Reported Event|Diphenhydramine Hydrochloride|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep
Diphenhydramine Hydrochloride: 30 mL at bedtime"
7042|NCT02577445|B3|Baseline|Total|Total of all reporting groups
7043|NCT02577445|B2|Baseline|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
7044|NCT02577445|B1|Baseline|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
7045|NCT02577445|P2|Participant Flow|CSA Patients With remedē System|"For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
Patients will be asked to complete quality of life questionnaires at baseline and during follow-up visits.
Patients will be evaluated at the time of therapy activation which may be followed by one or more titration visits. Patient follow-ups will be programmed at 6 and 12 months, and yearly, up to 5 years post-implant, until the last patients reach their 2-year follow-up.
Echocardiogram for patients with reduced ejection fraction (≤ 45%) and follow-up respiratory polygraphy are considered standard of care, however, to ensure sufficient data, related to the study objectives, are being collected, baseline and 12-months echocardiogram for a subgroup of patients and respiratory polygraphy at 12-month follow-up for all patients must be done when participating in this study:"
7046|NCT02577445|P1|Participant Flow|CSA Patients NOT Implanted With remedē System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
7047|NCT02577445|O2|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
7048|NCT02577445|O1|Outcome|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
7130|NCT02576639|O1|Outcome|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
7057|NCT02577315|B2|Baseline|Empagliflozin + Metformin / Fixed Dose Combination (FDC)|Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
7058|NCT02577315|B1|Baseline|Fixed Dose Combination (FDC) / Empagliflozin + Metformin|Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
7059|NCT02577315|P2|Participant Flow|Empagliflozin + Metformin / Fixed Dose Combination (FDC)|Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
7060|NCT02577315|P1|Participant Flow|Fixed Dose Combination (FDC) / Empagliflozin + Metformin|Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
7061|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7062|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7063|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7064|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7065|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7066|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7067|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7068|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7069|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7070|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7131|NCT02576639|O5|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7132|NCT02576639|O4|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7071|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7072|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7170|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7074|NCT02577315|E1|Reported Event|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
7075|NCT02576639|B6|Baseline|Total|Total of all reporting groups
7076|NCT02576639|B5|Baseline|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7077|NCT02576639|B4|Baseline|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7078|NCT02576639|B3|Baseline|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7079|NCT02576639|B2|Baseline|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7080|NCT02576639|B1|Baseline|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
7081|NCT02576639|P5|Participant Flow|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7082|NCT02576639|P4|Participant Flow|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7083|NCT02576639|P3|Participant Flow|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7084|NCT02576639|P2|Participant Flow|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7085|NCT02576639|P1|Participant Flow|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
7086|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7087|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7088|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7089|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7090|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7091|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7092|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7093|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7094|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7095|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7096|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7097|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7098|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7099|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7100|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7101|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7102|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7103|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7104|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7105|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7106|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7107|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7108|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7109|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7110|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7111|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7112|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7113|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7114|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7115|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7116|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7117|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7118|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7119|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7120|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7121|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7122|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7123|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7124|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7125|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
7126|NCT02576639|O5|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
7127|NCT02576639|O4|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
7128|NCT02576639|O3|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
7129|NCT02576639|O2|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
8064|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
7140|NCT02576639|E1|Reported Event|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
7141|NCT02576535|B1|Baseline|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
Fractionated stereotactic radiosurgery
Leskell gamma unit: FDA approved device"
7142|NCT02576535|P1|Participant Flow|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
Fractionated stereotactic radiosurgery
Leskell gamma unit: FDA approved device"
7209|NCT02575911|P1|Participant Flow|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
7143|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
Fractionated stereotactic radiosurgery
Leskell gamma unit: FDA approved device"
7144|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
Fractionated stereotactic radiosurgery
Leskell gamma unit: FDA approved device"
7145|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
Fractionated stereotactic radiosurgery
Leskell gamma unit: FDA approved device"
7146|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
Fractionated stereotactic radiosurgery
Leskell gamma unit: FDA approved device"
7147|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
Fractionated stereotactic radiosurgery
Leskell gamma unit: FDA approved device"
7148|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
Fractionated stereotactic radiosurgery
Leskell gamma unit: FDA approved device"
7149|NCT02576535|E1|Reported Event|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
Fractionated stereotactic radiosurgery
Leskell gamma unit: FDA approved device"
7150|NCT02576249|B3|Baseline|Total|Total of all reporting groups
7151|NCT02576249|B2|Baseline|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
7152|NCT02576249|B1|Baseline|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
7153|NCT02576249|P2|Participant Flow|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
7154|NCT02576249|P1|Participant Flow|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
7155|NCT02576249|O2|Outcome|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
7156|NCT02576249|O1|Outcome|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
7157|NCT02576249|O2|Outcome|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
7158|NCT02576249|O1|Outcome|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
7159|NCT02576249|O2|Outcome|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
7160|NCT02576249|O1|Outcome|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
7161|NCT02576249|E2|Reported Event|Saline and Methylprednisolone|0.9% normal saline and methylprednisolone knee joint injection
7162|NCT02576249|E1|Reported Event|Ropivacaine and Methylprednisolone|0.2% ropivacaine and methylprednisolone knee joint injection
7163|NCT02576145|B3|Baseline|Total|Total of all reporting groups
7164|NCT02576145|B2|Baseline|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7165|NCT02576145|B1|Baseline|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7166|NCT02576145|P2|Participant Flow|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7167|NCT02576145|P1|Participant Flow|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
8065|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
7168|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7169|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7210|NCT02575911|O2|Outcome|LenSx - 3 Months Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
7171|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7172|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7173|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7174|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7175|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7176|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7177|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7178|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7179|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7180|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7181|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7182|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7183|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7184|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7185|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7186|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7187|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7188|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7211|NCT02575911|O1|Outcome|LenSx - 1 Month Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
7212|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
7189|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7190|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7191|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7192|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7193|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7194|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7195|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7196|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7197|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7198|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7199|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7200|NCT02576145|E2|Reported Event|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
7201|NCT02576145|E1|Reported Event|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
7202|NCT02576041|B1|Baseline|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).
Bilastine: Bilastine tablets once a day for 7+3 days
Placebo: Placebo tablets once a day during 7+3 days run in period"
7203|NCT02576041|P1|Participant Flow|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).
Bilastine: Bilastine tablets once a day for 7+3 days
Placebo: Placebo tablets once a day during 7+3 days run in period"
7204|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
7205|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
7206|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
7207|NCT02576041|E1|Reported Event|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).
Bilastine: Bilastine tablets once a day for 7+3 days
Placebo: Placebo tablets once a day during 7+3 days run in period"
7208|NCT02575911|B1|Baseline|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
7225|NCT02575911|E1|Reported Event|Pre-treatment|All who consented to participate in the study prior to the initiation of study treatment
7226|NCT02574845|B7|Baseline|Total|Total of all reporting groups
7227|NCT02574845|B6|Baseline|REF-T1-T2-T3-T4-T5|The subjects received REF alone, followed by T1, followed by T2, followed by T3, followed by T4 and followed by T5. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7228|NCT02574845|B5|Baseline|T5-T4-T3-T2-T1-REF|The subjects received T5, followed by T4, followed by T3, followed by T2, followed by T1 and followed by REF alone. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7229|NCT02574845|B4|Baseline|T4-T2-T5-REF-T3-T1|The subjects received T4, followed by T2, followed by T5, followed by REF alone, followed by T3 and followed by T1. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7230|NCT02574845|B3|Baseline|T3-T5-T1-T4-REF-T2|The subjects received T3, followed by T5, followed by T1, followed by T4, followed by REF alone and followed by T2. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7231|NCT02574845|B2|Baseline|T2-REF-T4-T1-T5-T3|The subjects received T2, followed by REF alone, followed by T4, followed by T1, followed by T5 and followed by T3. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7232|NCT02574845|B1|Baseline|Treatment (T) 1-T3-Reference (REF)-T5-T2-T4|The subjects received test treatment 1 (T1) which is 10 milligram (mg) metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor) followed by test treatment 3 (T3) which is 500mg metformin hydrochloride together with REF followed by REF alone followed by test treatment 5 (T5) which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with REF followed by test treatment 2 (T2) which is 50 mg of metformin hydrochloride together with REF followed by test treatment 4 (T4) which is 1mg of furosemide together with REF. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7233|NCT02574845|P6|Participant Flow|REF-T1-T2-T3-T4-T5|The subjects received REF alone, followed by T1, followed by T2, followed by T3, followed by T4 and followed by T5. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7234|NCT02574845|P5|Participant Flow|T5-T4-T3-T2-T1-REF|The subjects received T5, followed by T4, followed by T3, followed by T2, followed by T1 and followed by REF alone. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7235|NCT02574845|P4|Participant Flow|T4-T2-T5-REF-T3-T1|The subjects received T4, followed by T2, followed by T5, followed by REF alone, followed by T3 and followed by T1. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7236|NCT02574845|P3|Participant Flow|T3-T5-T1-T4-REF-T2|The subjects received T3, followed by T5, followed by T1, followed by T4, followed by REF alone and followed by T2. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7237|NCT02574845|P2|Participant Flow|T2-REF-T4-T1-T5-T3|The subjects received T2, followed by REF alone, followed by T4, followed by T1, followed by T5 and followed by T3. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7238|NCT02574845|P1|Participant Flow|Treatment (T) 1-T3-Reference (REF)-T5-T2-T4|The subjects received test treatment 1 (T1) which is 10 milligram (mg) metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor) followed by test treatment 3 (T3) which is 500mg metformin hydrochloride together with REF followed by REF alone followed by test treatment 5 (T5) which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with REF followed by test treatment 2 (T2) which is 50 mg of metformin hydrochloride together with REF followed by test treatment 4 (T4) which is 1mg of furosemide together with REF. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
7239|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7240|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7241|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7345|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)
Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
7965|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
7242|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7243|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7244|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7245|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7246|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7247|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7248|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7249|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7250|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7251|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7252|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7253|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7254|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7255|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
8066|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
7256|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7257|NCT02574845|E6|Reported Event|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7258|NCT02574845|E5|Reported Event|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7259|NCT02574845|E4|Reported Event|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7260|NCT02574845|E3|Reported Event|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7261|NCT02574845|E2|Reported Event|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7262|NCT02574845|E1|Reported Event|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
7263|NCT02574260|B1|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
7346|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)
Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
7966|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
7264|NCT02574260|P1|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ plaque forming units (PFU)/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
7265|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
7266|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
7267|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
7268|NCT02574260|E1|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
7269|NCT02573870|B3|Baseline|Total|Total of all reporting groups
7270|NCT02573870|B2|Baseline|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
7271|NCT02573870|B1|Baseline|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
7272|NCT02573870|P2|Participant Flow|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed,while receiving investigational product.
7273|NCT02573870|P1|Participant Flow|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
7274|NCT02573870|O2|Outcome|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
7275|NCT02573870|O1|Outcome|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
7276|NCT02573870|E2|Reported Event|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
7277|NCT02573870|E1|Reported Event|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
7278|NCT02572752|B4|Baseline|Total|Total of all reporting groups
7279|NCT02572752|B3|Baseline|Nin 1x200 mg(T) / Nin 2x100 mg(R1) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water, followed in Period 2 (Reference treatment (R1)) and Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
7308|NCT02572427|B2|Baseline|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.
No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
7280|NCT02572752|B2|Baseline|Nin 2x100 mg(R1) / Nin 1x200 mg(T) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water, followed in Period 2 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water and in Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
7281|NCT02572752|B1|Baseline|Nin 2x100 mg(R1) / Nin 2x100 mg(R2) / Nin 1x200 mg(T)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) and Period 2 (Reference treatment (R2)) with nintedanib (nin) soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water, followed in Period 3 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
7282|NCT02572752|P3|Participant Flow|Nin 1x200 mg(T) / Nin 2x100 mg(R1) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water, followed in Period 2 (Reference treatment (R1)) and Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
7283|NCT02572752|P2|Participant Flow|Nin 2x100 mg(R1) / Nin 1x200 mg(T) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water, followed in Period 2 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water and in Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
7347|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)
Normal saline: Intravenous normal saline 0.9% 5 mL"
7348|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)
Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
7967|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
7284|NCT02572752|P1|Participant Flow|Nin 2x100 mg(R1) / Nin 2x100 mg(R2) / Nin 1x200 mg(T)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) and Period 2 (Reference treatment (R2)) with nintedanib (nin) soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water, followed in Period 3 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
7285|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
7286|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
7287|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
7288|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
7289|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
7290|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
7291|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
7292|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
7293|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
7294|NCT02572752|E2|Reported Event|Nintedanib, Reference Treatment (R1 & R2)|Subjects were treated twice with single oral dose of nintedanib soft gelatine capsule (Reference treatment (R1 & R2)), 200 mg (2x100mg) with about 240 mL of water.
7295|NCT02572752|E1|Reported Event|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose of nintedanib soft gelatine capsule (Test treatment (T)) , 200 mg (1x200mg) with about 240 mL of water.
7296|NCT02572609|B3|Baseline|Total|Total of all reporting groups
7297|NCT02572609|B2|Baseline|Sequence: RT|"2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2.
Washout period: 7 days"
7298|NCT02572609|B1|Baseline|Sequence: TR|"01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2.
Washout period: 7 days"
7299|NCT02572609|P2|Participant Flow|Sequence: RT|"2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2.
Washout period: 7 days"
7300|NCT02572609|P1|Participant Flow|Sequence: TR|"01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2.
Washout period: 7 days"
7301|NCT02572609|O2|Outcome|Ambroxol Hydrochloride Soft Pastille|01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product).
7302|NCT02572609|O1|Outcome|Mucosolvan ® Adult Syrup|2.5 mL, single dose, of Mucosolvan ® adult syrup 6 mg/mL (Reference product).
7303|NCT02572609|O2|Outcome|Ambroxol Hydrochloride Soft Pastille|01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product).
7304|NCT02572609|O1|Outcome|Mucosolvan ® Adult Syrup|2.5 mL, single dose, of Mucosolvan ® adult syrup 6 mg/mL (Reference product).
7305|NCT02572609|E2|Reported Event|Ambroxol Hydrochloride Soft Pastille|
7306|NCT02572609|E1|Reported Event|Mucosolvan® Adult Syrup|
7307|NCT02572427|B3|Baseline|Total|Total of all reporting groups
7309|NCT02572427|B1|Baseline|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.
Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
7310|NCT02572427|P2|Participant Flow|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.
No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
7311|NCT02572427|P1|Participant Flow|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.
Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
7312|NCT02572427|O2|Outcome|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.
No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
7349|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)
Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
7350|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)
Normal saline: Intravenous normal saline 0.9% 5 mL"
7313|NCT02572427|O1|Outcome|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.
Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
7314|NCT02572427|O2|Outcome|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.
No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
7315|NCT02572427|O1|Outcome|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.
Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
7316|NCT02572427|E2|Reported Event|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.
No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
7317|NCT02572427|E1|Reported Event|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.
Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
7318|NCT02571634|B1|Baseline|Open Label|"Open label, no blinding, everyone receives Lazanda.
Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
7319|NCT02571634|P1|Participant Flow|Open Label|"Open label, no blinding, everyone receives Lazanda.
Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
7320|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.
Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
7321|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.
Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
There were no adverse events."
7322|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.
Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
There were no adverse events."
7323|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.
Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
There were no adverse events."
7324|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.
Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
There were no adverse events."
7325|NCT02571634|E1|Reported Event|Open Label|"Open label, no blinding, everyone receives Lazanda.
Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
There were no adverse events."
7326|NCT02571153|B4|Baseline|Total|Total of all reporting groups
7327|NCT02571153|B3|Baseline|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)
Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
7328|NCT02571153|B2|Baseline|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)
Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
7329|NCT02571153|B1|Baseline|Saline Group|"Normal saline 0.9% (5 mL)
Normal saline: Intravenous normal saline 0.9% 5 mL"
7330|NCT02571153|P3|Participant Flow|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)
Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
7331|NCT02571153|P2|Participant Flow|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)
Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
7332|NCT02571153|P1|Participant Flow|Saline Group|"Normal saline 0.9% (5 mL)
Normal saline: Intravenous normal saline 0.9% 5 mL"
7333|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)
Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
7334|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)
Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
7335|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)
Normal saline: Intravenous normal saline 0.9% 5 mL"
7336|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)
Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
7337|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)
Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
7338|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)
Normal saline: Intravenous normal saline 0.9% 5 mL"
7339|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)
Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
7340|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)
Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
7341|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)
Normal saline: Intravenous normal saline 0.9% 5 mL"
7342|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)
Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
7343|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)
Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
7968|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
7351|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)
Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
7352|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)
Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
7353|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)
Normal saline: Intravenous normal saline 0.9% 5 mL"
7354|NCT02571153|E3|Reported Event|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)
Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
7355|NCT02571153|E2|Reported Event|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)
Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
7356|NCT02571153|E1|Reported Event|Saline Group|"Normal saline 0.9% (5 mL)
Normal saline: Intravenous normal saline 0.9% 5 mL"
7357|NCT02570425|B3|Baseline|Total|Total of all reporting groups
7358|NCT02570425|B2|Baseline|Budesonide/Formoterol (BF) Spiromax® First, Then Turbohaler®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7359|NCT02570425|B1|Baseline|SYMBICORT Turbohaler® First, Then Spiromax®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7360|NCT02570425|P2|Participant Flow|Placebo Comparator: Turbohaler Followed by Spiromax|Training on SYMBICORT Turbohaler followed by BF Spiromax
7361|NCT02570425|P1|Participant Flow|Placebo Comparator: Spiromax Followed by Turbohaler|Training on BF Spiromax followed by SYMBICORT Turbohaler
7362|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7511|NCT02568852|P2|Participant Flow|Group 2|Laparoscopic cholecystectomy under combined anaesthesia (Spino epidural).
7363|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7364|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7365|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7452|NCT02570165|O2|Outcome|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7366|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7367|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7368|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7369|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7370|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7409|NCT02570295|B1|Baseline|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
7371|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7372|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7373|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7969|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
7374|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7375|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7376|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7377|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7378|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7410|NCT02570295|P2|Participant Flow|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
8067|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
7379|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7380|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7423|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
7424|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
7970|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
7381|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7382|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7383|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7384|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
7385|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7411|NCT02570295|P1|Participant Flow|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
7412|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
7512|NCT02568852|P1|Participant Flow|Group 1|Laparoscopic cholecystectomy under general anaesthesia
8068|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
7386|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7387|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7388|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7389|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7390|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7391|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7392|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7413|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
8069|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
7393|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7394|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7395|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7396|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7397|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7398|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7399|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7414|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
7443|NCT02570165|P4|Participant Flow|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7400|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7401|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7402|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7403|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7404|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7405|NCT02570425|E2|Reported Event|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
7406|NCT02570425|E1|Reported Event|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
7407|NCT02570295|B3|Baseline|Total|Total of all reporting groups
7408|NCT02570295|B2|Baseline|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
7507|NCT02569658|E1|Reported Event|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Tranexamic Acid"
7415|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
7416|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
7417|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
7418|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
7419|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
7420|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
7421|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
7422|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
7425|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
7426|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
7427|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
7428|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
7429|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
7430|NCT02570295|E2|Reported Event|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
7431|NCT02570295|E1|Reported Event|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces
Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
7432|NCT02570165|B8|Baseline|Total|Total of all reporting groups
7433|NCT02570165|B7|Baseline|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
7434|NCT02570165|B6|Baseline|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7435|NCT02570165|B5|Baseline|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7436|NCT02570165|B4|Baseline|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7437|NCT02570165|B3|Baseline|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7438|NCT02570165|B2|Baseline|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7439|NCT02570165|B1|Baseline|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
7440|NCT02570165|P7|Participant Flow|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
7441|NCT02570165|P6|Participant Flow|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7442|NCT02570165|P5|Participant Flow|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7444|NCT02570165|P3|Participant Flow|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7445|NCT02570165|P2|Participant Flow|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7446|NCT02570165|P1|Participant Flow|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
7447|NCT02570165|O7|Outcome|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
7448|NCT02570165|O6|Outcome|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7449|NCT02570165|O5|Outcome|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7450|NCT02570165|O4|Outcome|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7451|NCT02570165|O3|Outcome|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7453|NCT02570165|O1|Outcome|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
7454|NCT02570165|O7|Outcome|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
7455|NCT02570165|O6|Outcome|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7456|NCT02570165|O5|Outcome|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7457|NCT02570165|O4|Outcome|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7458|NCT02570165|O3|Outcome|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7459|NCT02570165|O2|Outcome|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7460|NCT02570165|O1|Outcome|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
7461|NCT02570165|E7|Reported Event|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
7462|NCT02570165|E6|Reported Event|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7463|NCT02570165|E5|Reported Event|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7464|NCT02570165|E4|Reported Event|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7465|NCT02570165|E3|Reported Event|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained btefenterol blended with lactose.
7466|NCT02570165|E2|Reported Event|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
7467|NCT02570165|E1|Reported Event|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
7468|NCT02570022|B3|Baseline|Total|Total of all reporting groups
7508|NCT02568852|B3|Baseline|Total|Total of all reporting groups
7509|NCT02568852|B2|Baseline|Group 2|Laparoscopic cholecystectomy in under 14 mmHg pneumoperitoneum
7469|NCT02570022|B2|Baseline|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Inter-scalene nerve block: Pre-operative inter-scalene nerve block
Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
7470|NCT02570022|B1|Baseline|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
7471|NCT02570022|P2|Participant Flow|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Inter-scalene nerve block: Pre-operative inter-scalene nerve block
Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
7472|NCT02570022|P1|Participant Flow|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
7473|NCT02570022|O2|Outcome|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Inter-scalene nerve block: Pre-operative inter-scalene nerve block
Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
7474|NCT02570022|O1|Outcome|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
7475|NCT02570022|O2|Outcome|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Inter-scalene nerve block: Pre-operative inter-scalene nerve block
Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
7476|NCT02570022|O1|Outcome|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
7477|NCT02570022|E2|Reported Event|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Inter-scalene nerve block: Pre-operative inter-scalene nerve block
Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
7842|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7478|NCT02570022|E1|Reported Event|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
7479|NCT02569996|B1|Baseline|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
7480|NCT02569996|P1|Participant Flow|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
7481|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
7482|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
7483|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
7484|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
7485|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
7486|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
7487|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
7488|NCT02569996|E1|Reported Event|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
7489|NCT02569658|B3|Baseline|Total|Total of all reporting groups
7490|NCT02569658|B2|Baseline|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Placebo"
7491|NCT02569658|B1|Baseline|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Tranexamic Acid"
7492|NCT02569658|P2|Participant Flow|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Placebo"
7493|NCT02569658|P1|Participant Flow|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Tranexamic Acid"
7494|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Placebo"
7495|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Tranexamic Acid"
7496|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Placebo"
7497|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Tranexamic Acid"
7498|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Placebo"
7499|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Tranexamic Acid"
7500|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Placebo"
7501|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Tranexamic Acid"
7502|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Placebo"
7503|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Tranexamic Acid"
7504|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Placebo"
7505|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Tranexamic Acid"
7506|NCT02569658|E2|Reported Event|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Placebo"
7513|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7514|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7515|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7516|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7517|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7518|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7519|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7520|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7521|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7522|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7523|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7524|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7525|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7526|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7527|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7528|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7529|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7530|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7531|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7532|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7533|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7534|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7535|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7536|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7537|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7538|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7539|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7540|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7541|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7542|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7543|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
7544|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia
Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
7545|NCT02568852|E2|Reported Event|Group 2|Laparoscopic cholecystectomy in under spinal epidural anaesthesia.(10 mmHg CO2 pneumoperitoneum)
7546|NCT02568852|E1|Reported Event|Group 1|Laparoscopic cholecystectomy in under general anaesthesia.(10 mmHg CO2 pneumoperitoneum)
7566|NCT02568254|P2|Participant Flow|Etafilcon A/ Nesofilcon A/ Nelfilcon A|All subjects that were randomized to receive the etafilcon A lens first, the nesofilcon A lens second and the nelfilcon A lens third.
7547|NCT02568384|B1|Baseline|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population:
40 to 70% of subjects will have type 1 diabetes
Not more than 30% of subjects will use an insulin pump
Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
7548|NCT02568384|P1|Participant Flow|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population:
40 to 70% of subjects will have type 1 diabetes
Not more than 30% of subjects will use an insulin pump
Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
7549|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.
Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
7550|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.
Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
7551|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.
Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
7552|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.
Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
7578|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7553|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.
Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
7554|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.
Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
7555|NCT02568384|O1|Outcome|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home.
Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
7556|NCT02568384|E1|Reported Event|Users of Onyx BG Meter / App System|"Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population:
40 to 70% of subjects will have type 1 diabetes
Not more than 30% of subjects will use an insulin pump
Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions."
7557|NCT02568345|B1|Baseline|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).
The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.
sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.
In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
7558|NCT02568345|P1|Participant Flow|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).
The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.
sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.
In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
7559|NCT02568345|O1|Outcome|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).
The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.
sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.
In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
7560|NCT02568345|E1|Reported Event|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).
The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.
sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.
In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
7561|NCT02568254|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least 1 study lens.
7562|NCT02568254|P6|Participant Flow|Nesofilcon A/ Nelfilcon A/Etafilcon A|All subjects that were randomized to receive the nesofilcon A lens first, the nelfilcon A lens second and the etafilcon A lens third.
7563|NCT02568254|P5|Participant Flow|Nesolfilcon A/ Etafilcon A/ Nelfilcon A|All subjects that were randomized to receive the nesofilcon A lens first, the etafilcon A lens second and the nelfilcon A lens third.
7564|NCT02568254|P4|Participant Flow|Nelfilcon A/ Etafilcon A/ Nesofilcon A|All subjects that were randomzied to receive the nelfilcon A lens first, the etafilcon A lens second and the nesofilcon A lens third.
7565|NCT02568254|P3|Participant Flow|Nelfilcon A/ Nesofilcon A/ Etafilcon A|All subjects that were randomized to receive the nelfilcon A lens first, the nesofilcon A lens second and the etafilcon A lens third.
7567|NCT02568254|P1|Participant Flow|Etafilcon A/ Nelfilcon A/ Nesofilcon A|All subjects that were randomized to receive the etafilcon A lens first, the nelfilcon A lens second and the nesofilcon A lens third.
7568|NCT02568254|O3|Outcome|Nesofilcon A|All subjects that wore the nesofilcon A lens in any of the 3 periods in the study.
7569|NCT02568254|O2|Outcome|Nelfilcon A|All subjects that wore the nelfilcon A lens in any of the 3 periods of the study.
7570|NCT02568254|O1|Outcome|Etafilcon A|All subjects that wore the etafilcon A lens during any one of the 3 periods in the study.
7571|NCT02568254|E3|Reported Event|Nesofilcon A|All subjects that wore the nesofilcon A lens in any of the 3 periods in the study.
7572|NCT02568254|E2|Reported Event|Nelfilcon A|All subjects that wore the nelfilcon A lens in any of the 3 periods of the study.
7573|NCT02568254|E1|Reported Event|Etafilcon A|All subjects that wore the etafilcon A lens during any one of the 3 periods in the study.
7574|NCT02567188|B1|Baseline|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7575|NCT02567188|P1|Participant Flow|Chronic Kidney Disease (CKD) Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7576|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7577|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7713|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
7579|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7580|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7581|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7582|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7583|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7584|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7585|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7586|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7587|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7588|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7589|NCT02567188|O1|Outcome|Cohort of CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7590|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7591|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7592|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7593|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7594|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7595|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7596|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7597|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7598|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7599|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7600|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7601|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7602|NCT02567188|E1|Reported Event|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
7603|NCT02565628|B3|Baseline|Total|Total of all reporting groups
7604|NCT02565628|B2|Baseline|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7605|NCT02565628|B1|Baseline|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7606|NCT02565628|P2|Participant Flow|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7607|NCT02565628|P1|Participant Flow|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7608|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7609|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7610|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7611|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7612|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7613|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7614|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7615|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7616|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7617|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7618|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7619|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7700|NCT02563093|B1|Baseline|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7620|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7621|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7622|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7623|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7624|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7625|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7626|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7627|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7628|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7629|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7630|NCT02565628|O2|Outcome|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7631|NCT02565628|O1|Outcome|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7632|NCT02565628|E2|Reported Event|Placebo|Placebo matched to PF-06669571 was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 6 tablets everyday with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7633|NCT02565628|E1|Reported Event|PF-06669571 0.5 mg|PF-06669571 0.5 mg was orally administered on Day 1 through Day 7 as tablets. Participants swallowed 2 tablets on Days 1-3 (1 mg total) and 6 tablets (3 mg total) on Days 4-7 once daily, with ambient temperature water to a total volume of approximately 240 mL. A follow-up visit of 7-14 days after last dose of the treatment was completed.
7634|NCT02565381|B4|Baseline|Total|Total of all reporting groups
7635|NCT02565381|B3|Baseline|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7636|NCT02565381|B2|Baseline|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7637|NCT02565381|B1|Baseline|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7638|NCT02565381|P3|Participant Flow|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7639|NCT02565381|P2|Participant Flow|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7640|NCT02565381|P1|Participant Flow|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7641|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7642|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7945|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
7643|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7644|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7645|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7646|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7647|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7648|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7649|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7650|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7651|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7652|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7653|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7654|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7655|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7714|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7656|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7657|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7658|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7659|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7660|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7661|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7662|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7663|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7664|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7701|NCT02563093|P4|Participant Flow|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
7665|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7666|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7667|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7684|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Insulin: Insulin infusion for insulin/glucose clamp procedure"
7668|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7669|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7670|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7671|NCT02565381|O3|Outcome|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7672|NCT02565381|O2|Outcome|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7673|NCT02565381|O1|Outcome|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7674|NCT02565381|E3|Reported Event|Text Messaging (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT"
7675|NCT02565381|E2|Reported Event|Financial Rewards (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm"
7676|NCT02565381|E1|Reported Event|Control (N=25)|"Transdermal nicotine patch
In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
- <10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks"
7677|NCT02563834|B3|Baseline|Total|Total of all reporting groups
7678|NCT02563834|B2|Baseline|Type 2 Diabetes|Participants with Type 2 diabetes treated with any combination of oral agents and insulin except PPARgamma agonists.
7679|NCT02563834|B1|Baseline|Lean Controls|Lean non-diabetic control participants, taking no regular medications.
7702|NCT02563093|P3|Participant Flow|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7680|NCT02563834|P2|Participant Flow|Type 2 DM|"Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
7681|NCT02563834|P1|Participant Flow|Lean Control|"Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Saline: Saline infusion for control"
7682|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
7683|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
7946|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
7685|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Saline: Saline infusion for control"
7686|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
7687|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
7688|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Insulin: Insulin infusion for insulin/glucose clamp procedure"
7689|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Saline: Saline infusion for control"
7690|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
7691|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
7692|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Insulin: Insulin infusion for insulin/glucose clamp procedure"
7693|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Saline: Saline infusion for control"
7694|NCT02563834|E2|Reported Event|Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Insulin: Insulin infusion for insulin/glucose clamp procedure"
7695|NCT02563834|E1|Reported Event|Saline|"Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Saline: Saline infusion for control"
7696|NCT02563093|B5|Baseline|Total|Total of all reporting groups
7697|NCT02563093|B4|Baseline|Fluzone High-Dose Vaccine|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
7698|NCT02563093|B3|Baseline|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7699|NCT02563093|B2|Baseline|Fluzone Quadrivalent Intradermal Vaccine|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
8070|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
7703|NCT02563093|P2|Participant Flow|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
7704|NCT02563093|P1|Participant Flow|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7705|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
7706|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7707|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
7708|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7709|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
7710|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7711|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
7712|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7947|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
7715|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
7716|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7717|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
7718|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7719|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an Intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
7720|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7721|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
7722|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7723|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
7724|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7725|NCT02563093|E4|Reported Event|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
7726|NCT02563093|E3|Reported Event|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7727|NCT02563093|E2|Reported Event|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
7728|NCT02563093|E1|Reported Event|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
7729|NCT02561572|B3|Baseline|Total|Total of all reporting groups
7730|NCT02561572|B2|Baseline|Control|No intervention for 30 minutes.
7731|NCT02561572|B1|Baseline|Intervention|"Acupuncture at the Yintang point for 30 minutes.
Acupuncture: Yintang point acupuncture"
7732|NCT02561572|P2|Participant Flow|Control|No intervention for 30 minutes.
7733|NCT02561572|P1|Participant Flow|Intervention|"Acupuncture at the Yintang point for 30 minutes.
Acupuncture: Yintang point acupuncture"
7734|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
7735|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.
Acupuncture: Yintang point acupuncture"
7736|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
7737|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.
Acupuncture: Yintang point acupuncture"
7738|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
7739|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.
Acupuncture: Yintang point acupuncture"
7740|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
7741|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.
Acupuncture: Yintang point acupuncture"
7742|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
7743|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.
Acupuncture: Yintang point acupuncture"
7744|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
7745|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.
Acupuncture: Yintang point acupuncture"
7746|NCT02561572|E2|Reported Event|Control|No intervention for 30 minutes.
7747|NCT02561572|E1|Reported Event|Intervention|"Acupuncture at the Yintang point for 30 minutes.
Acupuncture: Yintang point acupuncture"
7748|NCT02559622|B5|Baseline|Total|Total of all reporting groups
7749|NCT02559622|B4|Baseline|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7750|NCT02559622|B3|Baseline|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7751|NCT02559622|B2|Baseline|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7752|NCT02559622|B1|Baseline|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7753|NCT02559622|P4|Participant Flow|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7754|NCT02559622|P3|Participant Flow|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7755|NCT02559622|P2|Participant Flow|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7756|NCT02559622|P1|Participant Flow|Secukinumab 300 mg|Participants were administered with 300 milligrams (mg) secukinumab subcutaneously (s.c.) using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7757|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7758|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7759|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7760|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7761|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7762|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7763|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7764|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7765|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7766|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7767|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7768|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7769|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7770|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7771|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7772|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7773|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7774|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7775|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7776|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7777|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7778|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7779|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7780|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7781|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7782|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7783|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7948|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
7784|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7785|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7786|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7787|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7788|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7789|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7790|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7791|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7792|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7793|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7794|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7795|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7796|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7797|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7798|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7799|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7800|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7801|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7877|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7802|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7803|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7804|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7805|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7806|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7807|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7808|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7809|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7841|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7949|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
7810|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7811|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7812|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7813|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7814|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7815|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7816|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7817|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7818|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7819|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7820|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7821|NCT02559622|O4|Outcome|Placebo Followed by 150 mg Secukinumab|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7822|NCT02559622|O3|Outcome|Placebo Followed by 300 mg Secukinumab|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7823|NCT02559622|O2|Outcome|Secukinumab 150 mg|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7824|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7825|NCT02559622|O2|Outcome|Placebo (Pooled)|Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).
7826|NCT02559622|O1|Outcome|Secukinumab 300 mg|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7827|NCT02559622|E7|Reported Event|Placebo Followed by Secukinumab (150 mg) After Week 12|Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7828|NCT02559622|E6|Reported Event|Placebo Followed by Secukinumab (300 mg) After Week 12|Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7829|NCT02559622|E5|Reported Event|Secukinumab (150 mg) After Week 12|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
7830|NCT02559622|E4|Reported Event|Secukinumab (300 mg) After Week 12|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
7831|NCT02559622|E3|Reported Event|Placebo up to Week 12|Participants were administered with placebo up to 12 weeks.
7832|NCT02559622|E2|Reported Event|Secukinumab (150 mg) up to Week 12|Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab up to 12 weeks.
7833|NCT02559622|E1|Reported Event|Secukinumab (300 mg) up to Week 12|Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab up to 12 weeks.
7834|NCT02557698|B3|Baseline|Total|Total of all reporting groups
7835|NCT02557698|B2|Baseline|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7836|NCT02557698|B1|Baseline|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7837|NCT02557698|P2|Participant Flow|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7838|NCT02557698|P1|Participant Flow|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7839|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7840|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7950|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
7843|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7844|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7845|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7846|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7847|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7848|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7849|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7850|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7851|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7852|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7853|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7854|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7855|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7856|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7857|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7858|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7859|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7860|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7861|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7862|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7863|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7864|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7865|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7866|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7867|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7868|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7869|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7870|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7871|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7872|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7873|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7874|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7875|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7876|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7878|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7879|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7880|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7881|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7882|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7883|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7884|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7885|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7886|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7887|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7888|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7889|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7890|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7891|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7892|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7893|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7894|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7895|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7896|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7897|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7898|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7899|NCT02557698|E2|Reported Event|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
7900|NCT02557698|E1|Reported Event|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks
Balneum oil bath"
7901|NCT02557646|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7902|NCT02557646|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a (Pegasys) and ribavirin (Copegus) in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7903|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7904|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7905|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7906|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7907|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7908|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7929|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
8071|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
8072|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
7909|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7910|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7911|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7912|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7913|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7951|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
7952|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
7914|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7915|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7916|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7917|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7918|NCT02557646|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
7919|NCT02557555|B1|Baseline|Labor Pain Control Pamphlet|All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil PCA, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
7920|NCT02557555|P1|Participant Flow|Labor Pain Control Pamphlet|All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil patient controlled analgesia, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
7921|NCT02557555|O2|Outcome|No %|Percentage of patients responding no to the key questions regarding the provided pamphlet educational value or anxiety
7922|NCT02557555|O1|Outcome|Yes %|Percentage of patients responding Yes to one of the key questions of the study regarding education value of the pamphlet and anxiety level.
7923|NCT02557555|E1|Reported Event|Labor Pain Control Pamphlet|All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil PCA, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
7924|NCT02556307|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
7925|NCT02556307|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
7926|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
7927|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
7928|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
7930|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
7931|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
7932|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
7933|NCT02556307|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
7934|NCT02555722|B3|Baseline|Total|Total of all reporting groups
7935|NCT02555722|B2|Baseline|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.
enfilcon A (control): silicone hydrogel lens"
7936|NCT02555722|B1|Baseline|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.
fanfilcon A (test): silicone hydrogel lens"
7937|NCT02555722|P2|Participant Flow|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.
enfilcon A (control): silicone hydrogel lens"
7938|NCT02555722|P1|Participant Flow|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.
fanfilcon A (test): silicone hydrogel lens"
7939|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
7940|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
7941|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
7942|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
7943|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
7944|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
7971|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
7972|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
7973|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
7974|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
7975|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
7976|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
7977|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
7978|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
7979|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
7980|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
7981|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
7982|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
7983|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
7984|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
7985|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
7986|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
7987|NCT02555722|O5|Outcome|Month 3|enfilcon A lens (control)
7988|NCT02555722|O4|Outcome|Month 2|enfilcon A lens (control)
7989|NCT02555722|O3|Outcome|Month 1|enfilcon A lens (control)
7990|NCT02555722|O2|Outcome|Week 2|enfilcon A lens (control)
7991|NCT02555722|O1|Outcome|Week 1|enfilcon A lens (control)
7992|NCT02555722|O5|Outcome|Month 3|fanfilcon A lens (test)
7993|NCT02555722|O4|Outcome|Month 2|fanfilcon A lens (test)
7994|NCT02555722|O3|Outcome|Month 1|fanfilcon A lens (test)
7995|NCT02555722|O2|Outcome|Week 2|fanfilcon A lens (test)
7996|NCT02555722|O1|Outcome|Week 1|fanfilcon A lens (test)
7997|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
7998|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
7999|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
8000|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
8001|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
8002|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
8003|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
8004|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
8005|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
8073|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
8074|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
8075|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
8076|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
8077|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
8078|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
8079|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
8080|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
8081|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
8082|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
8083|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
8084|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
8085|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
8086|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
8087|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
8088|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
8089|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
8090|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
8091|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
8092|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
8093|NCT02555722|E2|Reported Event|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.
enfilcon A (control): silicone hydrogel lens"
8094|NCT02555722|E1|Reported Event|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.
fanfilcon A (test): silicone hydrogel lens"
8095|NCT02555618|B3|Baseline|Total|Total of all reporting groups
8096|NCT02555618|B2|Baseline|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8097|NCT02555618|B1|Baseline|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8098|NCT02555618|P2|Participant Flow|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8099|NCT02555618|P1|Participant Flow|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8100|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8101|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8102|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8103|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8104|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8105|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8106|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8107|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8108|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8109|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8110|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8111|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8112|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8113|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8114|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8115|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8116|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8117|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8118|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8119|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8120|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8121|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8122|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8123|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8124|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8125|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8126|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8127|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8128|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8129|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8130|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8131|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8132|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8133|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8134|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8135|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8136|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8137|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8138|NCT02555618|E2|Reported Event|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
8139|NCT02555618|E1|Reported Event|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
8140|NCT02555228|B3|Baseline|Total|Total of all reporting groups
8141|NCT02555228|B2|Baseline|Placebo|"Just 5 mls of water
Water: 5mls of water is given at least 30 minutes before the gastroscopy."
8142|NCT02555228|B1|Baseline|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water
Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy."
8143|NCT02555228|P2|Participant Flow|Placebo|"Just 5 mls of water
Water: 5mls of water is given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8144|NCT02555228|P1|Participant Flow|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water
Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8145|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water
Water: 5mls of water is given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8146|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water
Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8147|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water
Water: 5mls of water is given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8148|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water
Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8149|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water
Water: 5mls of water is given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8150|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water
Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8151|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water
Water: 5mls of water is given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8152|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water
Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8153|NCT02555228|E2|Reported Event|Placebo|"Just 5 mls of water
Water: 5mls of water is given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8154|NCT02555228|E1|Reported Event|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water
Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.
27 patients randomized to this group."
8155|NCT02554981|B1|Baseline|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8156|NCT02554981|P1|Participant Flow|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8157|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8158|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8159|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8160|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8161|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8162|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8163|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8164|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8165|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8166|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8167|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8168|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8169|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8170|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8171|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8172|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8173|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8174|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8175|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8176|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8177|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8178|NCT02554981|E1|Reported Event|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
8179|NCT02554877|B5|Baseline|Total|Total of all reporting groups
8180|NCT02554877|B4|Baseline|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8181|NCT02554877|B3|Baseline|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8182|NCT02554877|B2|Baseline|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8183|NCT02554877|B1|Baseline|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8184|NCT02554877|P4|Participant Flow|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8185|NCT02554877|P3|Participant Flow|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8186|NCT02554877|P2|Participant Flow|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8187|NCT02554877|P1|Participant Flow|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8874|NCT02542072|O1|Outcome|Habitual Lenses (Baseline)|Habitual data were collected of participants before lens dispensed.
8188|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8189|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8190|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8191|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8192|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8193|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8194|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8195|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8196|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8197|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8198|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8199|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8200|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8201|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8202|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8203|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8204|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8205|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8206|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8207|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8208|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8209|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8210|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8211|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8212|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8213|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8214|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8215|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8216|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8217|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8218|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8219|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8220|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8221|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8222|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8223|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8224|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8225|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8226|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8227|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8228|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8229|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8230|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8231|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8232|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8233|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8234|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8235|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8236|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8237|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8238|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8239|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8240|NCT02554877|O4|Outcome|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8241|NCT02554877|O3|Outcome|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8242|NCT02554877|O2|Outcome|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8243|NCT02554877|O1|Outcome|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8244|NCT02554877|E4|Reported Event|PF-06291874 100 mg|Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8245|NCT02554877|E3|Reported Event|PF-06291874 60 mg|Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8246|NCT02554877|E2|Reported Event|PF-06291874 30 mg|Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8247|NCT02554877|E1|Reported Event|Placebo|Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
8248|NCT02553629|B3|Baseline|Total|Total of all reporting groups
8249|NCT02553629|B2|Baseline|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
Rocuronium"
8250|NCT02553629|B1|Baseline|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches
Rocuronium"
15859|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
8251|NCT02553629|P2|Participant Flow|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
Rocuronium"
8252|NCT02553629|P1|Participant Flow|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches
Rocuronium"
8253|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
Rocuronium"
8254|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches
Rocuronium"
8255|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
Rocuronium"
8256|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches
Rocuronium"
8257|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
Rocuronium"
8258|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches
Rocuronium"
8259|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
Rocuronium"
8260|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches
Rocuronium"
8261|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
Rocuronium"
8262|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches
Rocuronium"
8263|NCT02553629|E2|Reported Event|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
Rocuronium"
8264|NCT02553629|E1|Reported Event|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches
Rocuronium"
8265|NCT02553512|B1|Baseline|Helius|Ingestible Sensor and Wearable Sensor
8266|NCT02553512|P1|Participant Flow|Helius|Ingestible Sensor and Wearable Sensor
8267|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
8268|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
8269|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
8270|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
8271|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
8272|NCT02553512|E1|Reported Event|Helius|Ingestible Sensor and Wearable Sensor
8273|NCT02553421|B3|Baseline|Total|Total of all reporting groups
8335|NCT02551887|O2|Outcome|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
8274|NCT02553421|B2|Baseline|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.
ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
8275|NCT02553421|B1|Baseline|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.
ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
8276|NCT02553421|P2|Participant Flow|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.
ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
8277|NCT02553421|P1|Participant Flow|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.
ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
8278|NCT02553421|O1|Outcome|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.
ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
8279|NCT02553421|O2|Outcome|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.
ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
8280|NCT02553421|O1|Outcome|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.
ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
8281|NCT02553421|O1|Outcome|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.
ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
8282|NCT02553421|E2|Reported Event|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.
ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
8314|NCT02552303|O2|Outcome|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Placebo: Placebo for Nuvigil (armodafinil)"
9032|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo"
8283|NCT02553421|E1|Reported Event|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.
ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
8284|NCT02552810|B3|Baseline|Total|Total of all reporting groups
8285|NCT02552810|B2|Baseline|Control Group|Control group were cleaned by steam for 30s 7 by the dental technician in the laboratory located in the same clinic, but in a different room, immediately before delivering to the clinician. Then all the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.
8286|NCT02552810|B1|Baseline|Test Group|Test group abutments, after milled, polished and cleaned for 30s in the same laboratory, underwent argon plasma treatment (75 W of power and -10 MPa of pressure for 12 minutes at room temperature) in a plasma reactor8 located in the same clinic but in a different room. All the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.
8287|NCT02552810|P2|Participant Flow|Steam Clean|"Cleaning protocol by steaming.
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
8288|NCT02552810|P1|Participant Flow|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
8289|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
8336|NCT02551887|O1|Outcome|Usual Care|Non-interventional study arm. Patients receive usual care.
9373|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
8290|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
8291|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
8292|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
8293|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
8294|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
8315|NCT02552303|O1|Outcome|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Armodafinil: Active medication"
8316|NCT02552303|O4|Outcome|Placebo|"Placebo only, without CBTI.
Placebo: Placebo for Nuvigil (armodafinil)"
8317|NCT02552303|O3|Outcome|Armodafinil|"Medication (armodafinil) only, without CBTI.
Armodafinil: Active medication"
8295|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
8296|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
8297|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
8298|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
8299|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
8300|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
9374|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
8301|NCT02552810|E2|Reported Event|Steam Clean|"Cleaning protocol by steaming.
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
8302|NCT02552810|E1|Reported Event|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .
Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).
Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
8303|NCT02552303|B5|Baseline|Total|Total of all reporting groups
8304|NCT02552303|B4|Baseline|Placebo|"Placebo only, without CBTI.
Placebo: Placebo for Nuvigil (armodafinil)"
8305|NCT02552303|B3|Baseline|Armodafinil|"Medication (armodafinil) only, without CBTI.
Armodafinil: Active medication"
8306|NCT02552303|B2|Baseline|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Placebo: Placebo for Nuvigil (armodafinil)"
8307|NCT02552303|B1|Baseline|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Armodafinil: Active medication"
8308|NCT02552303|P4|Participant Flow|Placebo|"Placebo only, without CBTI.
Placebo: Placebo for Nuvigil (armodafinil)"
8309|NCT02552303|P3|Participant Flow|Armodafinil|"Medication (armodafinil) only, without CBTI.
Armodafinil: Active medication"
8310|NCT02552303|P2|Participant Flow|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Placebo: Placebo for Nuvigil (armodafinil)"
8311|NCT02552303|P1|Participant Flow|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Armodafinil: Active medication"
8312|NCT02552303|O4|Outcome|Placebo|"Placebo only, without CBTI.
Placebo: Placebo for Nuvigil (armodafinil)"
8313|NCT02552303|O3|Outcome|Armodafinil|"Medication (armodafinil) only, without CBTI.
Armodafinil: Active medication"
9033|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539"
8318|NCT02552303|O2|Outcome|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Placebo: Placebo for Nuvigil (armodafinil)"
8319|NCT02552303|O1|Outcome|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Armodafinil: Active medication"
8320|NCT02552303|E4|Reported Event|Placebo|"Placebo only, without CBTI.
Placebo: Placebo for Nuvigil (armodafinil)"
8321|NCT02552303|E3|Reported Event|Armodafinil|"Medication (armodafinil) only, without CBTI.
Armodafinil: Active medication"
8322|NCT02552303|E2|Reported Event|CBTI + Placebo|"Cognitive Behavioral Therapy for Insomnia with Placebo medication
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Placebo: Placebo for Nuvigil (armodafinil)"
8323|NCT02552303|E1|Reported Event|CBT for Insomnia (CBTI) + Armodafinil|"CBT-I with Armodafinil (active medication)
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia.
Armodafinil: Active medication"
8324|NCT02551887|B4|Baseline|Total|Total of all reporting groups
8325|NCT02551887|B3|Baseline|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
8326|NCT02551887|B2|Baseline|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
8327|NCT02551887|B1|Baseline|Usual Care|Non-interventional study arm. Patients receive usual care.
8328|NCT02551887|P3|Participant Flow|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
8329|NCT02551887|P2|Participant Flow|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
8330|NCT02551887|P1|Participant Flow|Usual Care|Non-interventional study arm. Patients receive usual care.
8331|NCT02551887|O3|Outcome|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
8332|NCT02551887|O2|Outcome|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
8333|NCT02551887|O1|Outcome|Usual Care|Non-interventional study arm. Patients receive usual care.
8334|NCT02551887|O3|Outcome|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
9375|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
8337|NCT02551887|E3|Reported Event|Automated Reminder Plus Recommended Script|In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
8338|NCT02551887|E2|Reported Event|Automated Reminder|Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
8339|NCT02551887|E1|Reported Event|Usual Care|Patients receive usual care.
8340|NCT02550288|B6|Baseline|Total|Total of all reporting groups
8341|NCT02550288|B5|Baseline|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8342|NCT02550288|B4|Baseline|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8343|NCT02550288|B3|Baseline|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8344|NCT02550288|B2|Baseline|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8345|NCT02550288|B1|Baseline|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8346|NCT02550288|P5|Participant Flow|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8347|NCT02550288|P4|Participant Flow|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8348|NCT02550288|P3|Participant Flow|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8349|NCT02550288|P2|Participant Flow|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8350|NCT02550288|P1|Participant Flow|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8351|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8352|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8353|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8354|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8355|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8356|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8357|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8358|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
15860|NCT02427984|O2|Outcome|Control|
8359|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8360|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8361|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8362|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8363|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8364|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8365|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8366|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8367|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8368|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8369|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8370|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8371|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8372|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8373|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8374|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8375|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8376|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8377|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
9548|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
8378|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8379|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8380|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8381|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8382|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8383|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8384|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8385|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8386|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8387|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8388|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8389|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8390|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8391|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8392|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8393|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8394|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8395|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8396|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8397|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8398|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
9403|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
8399|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8400|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8401|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8402|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8403|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8404|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8405|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8406|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8407|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8408|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8409|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8410|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8411|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8412|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8413|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8414|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8415|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8416|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8417|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8418|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8419|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8420|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8421|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8422|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8423|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8424|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8425|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8426|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8427|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8428|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8429|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8430|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8431|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8432|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8433|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8434|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8435|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8436|NCT02550288|O5|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8437|NCT02550288|O4|Outcome|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8438|NCT02550288|O3|Outcome|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8439|NCT02550288|O2|Outcome|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8440|NCT02550288|O1|Outcome|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8441|NCT02550288|E5|Reported Event|Ezetimibe 10 mg + Atorvastatin 20 mg|1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
8442|NCT02550288|E4|Reported Event|Ezetimibe 10 mg + Atorvastatin 10 mg|1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
8443|NCT02550288|E3|Reported Event|Atorvastatin 20 mg|2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
8444|NCT02550288|E2|Reported Event|Atorvastatin 10 mg|1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
8445|NCT02550288|E1|Reported Event|Ezetimibe 10 mg|1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
8446|NCT02550197|B3|Baseline|Total|Total of all reporting groups
8447|NCT02550197|B2|Baseline|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
8448|NCT02550197|B1|Baseline|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
8449|NCT02550197|P2|Participant Flow|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
8450|NCT02550197|P1|Participant Flow|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
8451|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
8452|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
8453|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
8454|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
8455|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
8456|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
8457|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
8458|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
8459|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
8460|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
8461|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
8462|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
8463|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
8464|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
8465|NCT02550197|E2|Reported Event|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
8466|NCT02550197|E1|Reported Event|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
8467|NCT02550132|B1|Baseline|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8468|NCT02550132|P1|Participant Flow|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8469|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8470|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8471|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8472|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8473|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8474|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8475|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8476|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8559|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8477|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8478|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8479|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8480|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8481|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8482|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8483|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8484|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
15861|NCT02427984|O1|Outcome|Metal on Metal (MoM)|
8485|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8486|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8487|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8488|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8489|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8490|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8491|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8560|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
11933|NCT02479763|O1|Outcome|Conventional Loss-of-resistance|
8492|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8493|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8494|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8495|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8496|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8497|NCT02550132|E1|Reported Event|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
8498|NCT02549027|B1|Baseline|All Study Participants|
8499|NCT02549027|P6|Participant Flow|Placebo (Period 5)|Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of placebo in Period 5.
8500|NCT02549027|P5|Participant Flow|MK-6096 20 mg (Period 5)|Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of 20 mg of MK-6096 in Period 5.
8501|NCT02549027|P4|Participant Flow|MK-1064: 250 mg→120 mg→50 mg→Placebo (Period 1-4)|Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo.
8651|NCT02548156|E2|Reported Event|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
8502|NCT02549027|P3|Participant Flow|MK-1064: 120 mg→Placebo→250 mg→50 mg (Period 1-4)|Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064.
8503|NCT02549027|P2|Participant Flow|MK-1064: Placebo→50 mg→120 mg→250 mg (Period 1-4)|Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064.
8504|NCT02549027|P1|Participant Flow|MK-1064: 50 mg→250 mg→Placebo→120 mg (Period 1-4)|Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064.
8505|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
8506|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
8507|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
8508|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
8509|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
8510|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
8511|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
8512|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
8513|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
8514|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
8515|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
8516|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
8517|NCT02549027|O5|Outcome|Placebo|Single dose of placebo
8518|NCT02549027|O4|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
8519|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
8520|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
8521|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
8522|NCT02549027|O5|Outcome|Placebo|Single dose of placebo
8523|NCT02549027|O4|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
8524|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
8525|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
8526|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
8527|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
8528|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
8529|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
8530|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
8531|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
8532|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
8533|NCT02549027|E5|Reported Event|Placebo|Single dose of placebo
8534|NCT02549027|E4|Reported Event|MK-6096 20 mg|Single dose of 20 mg MK-6096
8535|NCT02549027|E3|Reported Event|MK-1064 250 mg|Single dose of 250 mg MK-1064
8536|NCT02549027|E2|Reported Event|MK-1064 120 mg|Single dose of 120 mg MK-1064
8537|NCT02549027|E1|Reported Event|MK-1064 50 mg|Single dose of 50 mg MK-1064
8538|NCT02549014|B3|Baseline|Total|Total of all reporting groups
8539|NCT02549014|B2|Baseline|Panel B: MK-1064|Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
8540|NCT02549014|B1|Baseline|Panel A: MK-1064|Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
8541|NCT02549014|P2|Participant Flow|Panel B: MK-1064|Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
8542|NCT02549014|P1|Participant Flow|Panel A: MK-1064|Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
8543|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
8544|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
8545|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
15862|NCT02427984|E3|Reported Event|Controls|
8546|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8547|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8548|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8549|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8550|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8551|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8552|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8553|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8554|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
8555|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
8556|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
8557|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8558|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8696|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8561|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8562|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8563|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8564|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8565|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
8566|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
8567|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
8568|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8569|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8570|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8571|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8572|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8652|NCT02548156|E1|Reported Event|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
8573|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8574|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8575|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8576|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
8577|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
8578|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
8579|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8580|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8581|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8582|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8583|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8584|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8585|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8586|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
9549|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
8587|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
8588|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
8589|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
8590|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8591|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8592|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8593|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8594|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8595|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8596|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8597|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8598|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
8599|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
8600|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
8601|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8602|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8603|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8604|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8605|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8606|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8607|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8608|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8609|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
8610|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
8611|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
8612|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8613|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8614|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8615|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8616|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8617|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8618|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8619|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8620|NCT02549014|E11|Reported Event|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
8621|NCT02549014|E10|Reported Event|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
8622|NCT02549014|E9|Reported Event|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
8623|NCT02549014|E8|Reported Event|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8624|NCT02549014|E7|Reported Event|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8625|NCT02549014|E6|Reported Event|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8626|NCT02549014|E5|Reported Event|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8627|NCT02549014|E4|Reported Event|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8628|NCT02549014|E3|Reported Event|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8629|NCT02549014|E2|Reported Event|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8630|NCT02549014|E1|Reported Event|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
8631|NCT02548156|B1|Baseline|Overall Study|All the participants randomized in this study.
8632|NCT02548156|P6|Participant Flow|Sequence 6: Reference/Comparator/Test: Dentifrice|Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
8633|NCT02548156|P5|Participant Flow|Sequence 5: Reference/Test/Comparator: Dentifrice|Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
8634|NCT02548156|P4|Participant Flow|Sequence 4: Comparator/Reference/Test: Dentifrice|Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
8635|NCT02548156|P3|Participant Flow|Sequence 3: Comparator/Test/Reference: Dentifrice|Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
9128|NCT02539134|O2|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
8636|NCT02548156|P2|Participant Flow|Sequence 2: Test/Reference/Comparator: Dentifrice|Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
8637|NCT02548156|P1|Participant Flow|Sequence 1: Test/Comparator/Reference: Dentifrice|Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
8638|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
8639|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
8640|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
8641|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
8642|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
8643|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
8644|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
8645|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
8646|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
8647|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
8648|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
8649|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
8650|NCT02548156|E3|Reported Event|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
8653|NCT02547714|B1|Baseline|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
8654|NCT02547714|P1|Participant Flow|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
8655|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
8656|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
8657|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
8658|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
8659|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
8660|NCT02547714|O1|Outcome|Secukinumab (AIN457) 300 mg|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
8661|NCT02547714|E2|Reported Event|Induction Period - Secukinumab (AIN457)|During the induction period, participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, and 4.
8662|NCT02547714|E1|Reported Event|Entire Period - Secukinumab (AIN457)|Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
8663|NCT02547454|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8664|NCT02547454|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with chronic kidney disease (CKD), who did not require dialysis, received methoxy polyethylene glycol-epoetin beta (Mircera) either intravenously (IV) or subcutaneously (SC), as per routine clinical practice, and were followed for approximately 36 months.
8665|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8666|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8667|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8697|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8668|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8669|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8670|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8671|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8672|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8673|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8674|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8675|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8676|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8677|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8678|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8679|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8680|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
9034|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539"
8681|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8682|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8683|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8684|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8685|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8686|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8687|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8688|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8689|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8690|NCT02547454|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
8691|NCT02547064|B3|Baseline|Total|Total of all reporting groups
8692|NCT02547064|B2|Baseline|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8693|NCT02547064|B1|Baseline|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8694|NCT02547064|P2|Participant Flow|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8695|NCT02547064|P1|Participant Flow|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8764|NCT02543437|O1|Outcome|X3 Liner|"X3 28mm, 32mm and 36mm liner
Trident Acetabular X3 Insert"
8698|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8699|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8700|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8701|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8702|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8703|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8704|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8705|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8706|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8707|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8708|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8709|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8710|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8711|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8712|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8713|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
9035|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo"
8714|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8715|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8716|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8717|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8718|NCT02547064|E2|Reported Event|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope®"
8719|NCT02547064|E1|Reported Event|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope®"
8720|NCT02545543|B3|Baseline|Total|Total of all reporting groups
8721|NCT02545543|B2|Baseline|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8722|NCT02545543|B1|Baseline|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8723|NCT02545543|P2|Participant Flow|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8765|NCT02543437|E1|Reported Event|X3 Liner|"X3 28mm, 32mm and 36mm liner
Trident Acetabular X3 Insert"
8766|NCT02542943|B4|Baseline|Total|Total of all reporting groups
8767|NCT02542943|B3|Baseline|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8724|NCT02545543|P1|Participant Flow|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8725|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8726|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8727|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8779|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8780|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
11967|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
8728|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8729|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8730|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8731|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8732|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8733|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8768|NCT02542943|B2|Baseline|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
8734|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8735|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8736|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8737|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8738|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8739|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8740|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8741|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8742|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8743|NCT02545543|O1|Outcome|SCR Difference = Comparator QIV SCR % Minus Seqirus QIV SCR %|Seroconversion rate difference = Comparator QIV SCR percentage minus Seqirus QIV SCR percentage
8744|NCT02545543|O1|Outcome|GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV|GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
8769|NCT02542943|B1|Baseline|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8770|NCT02542943|P3|Participant Flow|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
9550|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
8745|NCT02545543|E2|Reported Event|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8746|NCT02545543|E1|Reported Event|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
8747|NCT02545322|B1|Baseline|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment
Image-guided adaptive Radiotherapy arm:
Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
8781|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8782|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
11968|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
8748|NCT02545322|P1|Participant Flow|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment
Image-guided adaptive Radiotherapy arm:
Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
8749|NCT02545322|O1|Outcome|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment
Image-guided adaptive Radiotherapy arm:
Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
8750|NCT02545322|O1|Outcome|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment
Image-guided adaptive Radiotherapy arm:
Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
8751|NCT02545322|E1|Reported Event|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment
Image-guided adaptive Radiotherapy arm:
Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
8752|NCT02543918|B3|Baseline|Total|Total of all reporting groups
8753|NCT02543918|B2|Baseline|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
8754|NCT02543918|B1|Baseline|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
8755|NCT02543918|P2|Participant Flow|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
8756|NCT02543918|P1|Participant Flow|Ixekizumab + Boostrix® + Pneumovax®23|"Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2.
Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2."
8757|NCT02543918|O2|Outcome|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
8758|NCT02543918|O1|Outcome|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
8759|NCT02543918|E2|Reported Event|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
8760|NCT02543918|E1|Reported Event|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
8761|NCT02543437|B1|Baseline|X3 Liner|"X3 28mm, 32mm and 36mm liner
Trident Acetabular X3 Insert"
8762|NCT02543437|P1|Participant Flow|Trident Acetabular X3 Insert|Trident Acetabular X3 Insert 28mm, 32mm and 36mm liner
8763|NCT02543437|O1|Outcome|X3 Liner|"X3 28mm, 32mm and 36mm liner
Trident Acetabular X3 Insert"
8771|NCT02542943|P2|Participant Flow|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
8772|NCT02542943|P1|Participant Flow|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% weight by weight (w/w) dipotasium oxalate monohydrate [KOX], pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8773|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8774|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
8775|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8776|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8777|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
8778|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
15863|NCT02427984|E2|Reported Event|Ceramic on Ceramic (CoC)|
8783|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
8784|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8785|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8786|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
8787|NCT02542943|O1|Outcome|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8788|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
8789|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8790|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8791|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
8792|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8793|NCT02542943|E3|Reported Event|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8794|NCT02542943|E2|Reported Event|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
8795|NCT02542943|E1|Reported Event|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
8796|NCT02542280|B3|Baseline|Total|Total of all reporting groups
8797|NCT02542280|B2|Baseline|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
8820|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8821|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
12024|NCT02478671|B1|Baseline|TR Band|MRI based Radial artery measurement
8798|NCT02542280|B1|Baseline|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.
endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
8799|NCT02542280|P2|Participant Flow|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
8800|NCT02542280|P1|Participant Flow|Endometrial Injury|"Endometrial injury during ovarian stimulation cycle combined with intrauterine insemination.
endometrial injury: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
8801|NCT02542280|O2|Outcome|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
8802|NCT02542280|O1|Outcome|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.
endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
8803|NCT02542280|O2|Outcome|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
8804|NCT02542280|O1|Outcome|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.
endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
8805|NCT02542280|E2|Reported Event|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
8806|NCT02542280|E1|Reported Event|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.
endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
8807|NCT02542072|B1|Baseline|Overall Baseline Characteristics|"Participants were randomized to wear the comfilcon A lens pair or samfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lenses
samfilcon A: contact lenses"
8808|NCT02542072|P2|Participant Flow|Samfilcon A, Then Comfilcon A|"Participants were randomized to wear the samfilcon A lens pair for one month then cross over to the comfilcon A lens pair.
samfilcon A: contact lens
comfilcon A: contact lens"
8809|NCT02542072|P1|Participant Flow|Comfilcon A, Then Samfilcon A|"Participants were randomized to wear the comfilcon A lens pair for one month, then cross over to the samfilcon A lens pair.
comfilcon A: contact lens
samfilcon A: contact lens"
8810|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8811|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8812|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8813|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8814|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
8815|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8816|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8817|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8818|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8819|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8932|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
8822|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8823|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8824|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8825|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8826|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8827|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8828|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8829|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8830|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8831|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8832|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8833|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8834|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8835|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8836|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
15864|NCT02427984|E1|Reported Event|Metal on Metal (MoM)|
8837|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8838|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8839|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8840|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8841|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8842|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8843|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8844|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8845|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8846|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8847|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8848|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8849|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8850|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8851|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8852|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8853|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8854|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8855|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
8856|NCT02542072|O4|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8857|NCT02542072|O3|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8858|NCT02542072|O2|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
18388|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
8859|NCT02542072|O1|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8860|NCT02542072|O4|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8861|NCT02542072|O3|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8862|NCT02542072|O2|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8863|NCT02542072|O1|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8864|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8865|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8866|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8867|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8868|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8869|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8870|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8871|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8872|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8873|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8875|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8876|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8877|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8878|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8879|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
8880|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8881|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8882|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8883|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8884|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
8885|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8886|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8887|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8888|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8889|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
8890|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8891|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8892|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8893|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8894|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
8895|NCT02542072|O6|Outcome|Samfilcon A (Day 26)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8896|NCT02542072|O5|Outcome|Comfilcon A (Day 26)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
9129|NCT02539134|O1|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
8897|NCT02542072|O4|Outcome|Samfilcon A (Day 12)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8898|NCT02542072|O3|Outcome|Comfilcon A (Day 12)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8899|NCT02542072|O2|Outcome|Samfilcon A (Day 3)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8900|NCT02542072|O1|Outcome|Comfilcon A (Day 3)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8901|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8902|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8903|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8904|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8905|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
8906|NCT02542072|E2|Reported Event|Samfilcon A|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
samfilcon A: contact lens"
8907|NCT02542072|E1|Reported Event|Comfilcon A|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
comfilcon A: contact lens"
8908|NCT02541864|B3|Baseline|Total|Total of all reporting groups
8909|NCT02541864|B2|Baseline|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days
Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
8910|NCT02541864|B1|Baseline|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days
pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
11969|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
8911|NCT02541864|P2|Participant Flow|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days
Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
8912|NCT02541864|P1|Participant Flow|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days
pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
8913|NCT02541864|O2|Outcome|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days
Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
8914|NCT02541864|O1|Outcome|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days
pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
8915|NCT02541864|E2|Reported Event|Hybrid Therapy|"a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days
Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days"
8916|NCT02541864|E1|Reported Event|Pantoprazole+Bismuth+Tetra+Metro|"pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days
pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days"
8917|NCT02540850|B4|Baseline|Total|Total of all reporting groups
8918|NCT02540850|B3|Baseline|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
8919|NCT02540850|B2|Baseline|Precancerous Disease Group|subjects with adenoma or polyps
8920|NCT02540850|B1|Baseline|CRC Group|stage 0-IV CRC subjects
8921|NCT02540850|P3|Participant Flow|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
8922|NCT02540850|P2|Participant Flow|Precancerous Disease Group|subjects with adenoma or polyps
8923|NCT02540850|P1|Participant Flow|CRC Group|stage 0-IV CRC subjects
8924|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
8925|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
8926|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
8927|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
8928|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
8929|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
8930|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
8931|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
8933|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
8934|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
8935|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
8936|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
8937|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
8938|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
8939|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
8940|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
8941|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
8942|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
8943|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
8944|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
8945|NCT02540850|E3|Reported Event|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
8946|NCT02540850|E2|Reported Event|Precancerous Disease Group|subjects with adenoma or polyps
8947|NCT02540850|E1|Reported Event|CRC Group|stage 0-IV CRC subjects
8948|NCT02540772|B3|Baseline|Total|Total of all reporting groups
8949|NCT02540772|B2|Baseline|No Treatment|Patients in the control group only performed the baselines.
8950|NCT02540772|B1|Baseline|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
8951|NCT02540772|P2|Participant Flow|No Treatment|Patients in the control group only performed the baselines.
8971|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.
Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
8952|NCT02540772|P1|Participant Flow|Neuropsychological Treatment|"The tested treatment is a combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
Neuropsychological treatment: Participants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors. This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment."
8953|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
8954|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
8955|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
8956|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
8957|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
8958|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
8959|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
8960|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
8961|NCT02540772|E2|Reported Event|No Treatment|Patients in the control group only performed the baselines.
8962|NCT02540772|E1|Reported Event|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
8963|NCT02540447|B3|Baseline|Total|Total of all reporting groups
8964|NCT02540447|B2|Baseline|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
8965|NCT02540447|B1|Baseline|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.
Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
8966|NCT02540447|P2|Participant Flow|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
9015|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9130|NCT02539134|O5|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
8967|NCT02540447|P1|Participant Flow|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.
Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
8968|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
8969|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.
Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
8970|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
8972|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
8973|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.
Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
8974|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
8975|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.
Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
8976|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
8977|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.
Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
8978|NCT02540447|E2|Reported Event|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
8979|NCT02540447|E1|Reported Event|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.
Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
8980|NCT02540434|B3|Baseline|Total|Total of all reporting groups
9016|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
8981|NCT02540434|B2|Baseline|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.
ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of curve.
Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
8982|NCT02540434|B1|Baseline|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.
ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.
RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
8983|NCT02540434|P2|Participant Flow|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.
ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of curve.
Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
9030|NCT02540265|P2|Participant Flow|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539"
8984|NCT02540434|P1|Participant Flow|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.
ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.
RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
8985|NCT02540434|O2|Outcome|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present. ROTEM delta will be used to identify intraoperative coagulation abnormalities.
Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cry"
8986|NCT02540434|O1|Outcome|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.
ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.
RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
8987|NCT02540434|O2|Outcome|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if the ROTEM FIBTEM A10 value less than or equal to 10 mm and microvascular bleeding is present.
ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.
Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
8988|NCT02540434|O1|Outcome|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.
ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.
RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
9131|NCT02539134|O4|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
8989|NCT02540434|E2|Reported Event|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen.
Only enrolled patients randomized to RiaSTAP are at risk for riastap-related adverse events. 0 subjects out of total 22 consented were randomized to this arm, so no subjects were at risk to adverse events from this arm."
8990|NCT02540434|E1|Reported Event|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present. ROTEM delta will be used to identify intraoperative coagulation abnormalities. Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate.
Only enrolled patients randomized to cryoprecipitate arm are at risk for cryoprecipitate-related adverse events. 1 subject out of total 22 consented were randomized to this arm, so 1 subject was at risk to adverse events from this arm. No events were reported."
8991|NCT02540356|B3|Baseline|Total|Total of all reporting groups
8992|NCT02540356|B2|Baseline|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
8993|NCT02540356|B1|Baseline|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
8994|NCT02540356|P2|Participant Flow|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
8995|NCT02540356|P1|Participant Flow|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
8996|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
8997|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9031|NCT02540265|P1|Participant Flow|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539"
8998|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
8999|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9000|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9001|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9002|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9003|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9004|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9005|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9006|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9007|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9008|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9009|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9010|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9011|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9012|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9013|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9014|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9132|NCT02539134|O3|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
9017|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9018|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9019|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9020|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9021|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9022|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9023|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
9024|NCT02540356|E1|Reported Event|Overall Trial|Treatment with Imalumab (BAX69) over a 4-week treatment period administered weekly at one of the following dose regimens: BAX69 5mg/kg IP (intraperitoneal) (Cohort S1), 10mg/kg IP (Cohort S2), 15mg/kg IP (Cohort S3), 5mg/kg IV (intravenous) + 5mg/kg IP (intraperitoneal) (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
9025|NCT02540265|B4|Baseline|Total|Total of all reporting groups
9026|NCT02540265|B3|Baseline|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo"
9027|NCT02540265|B2|Baseline|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539"
9028|NCT02540265|B1|Baseline|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539"
9029|NCT02540265|P3|Participant Flow|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo"
15865|NCT02427750|B3|Baseline|Total|Total of all reporting groups
9036|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539"
9037|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539"
9038|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo"
9039|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539"
9040|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539"
9041|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo"
9042|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539"
9043|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539"
9044|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo"
9045|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539"
9046|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539"
9047|NCT02540265|E3|Reported Event|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.
Intravenous Placebo"
9048|NCT02540265|E2|Reported Event|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
N1539"
9049|NCT02540265|E1|Reported Event|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
N1539"
9050|NCT02540213|B1|Baseline|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9051|NCT02540213|P1|Participant Flow|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 micrograms per kilogram (mcg/kg) body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 grams per deciliter (g/dL), the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight)..
9052|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9053|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
18389|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
9054|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9055|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9056|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9057|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9058|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9059|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9060|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9152|NCT02539134|O1|Outcome|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
9061|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9062|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9063|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9064|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9065|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9066|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9067|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9068|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9090|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
9069|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9070|NCT02540213|E1|Reported Event|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9071|NCT02539992|B4|Baseline|Total|Total of all reporting groups
9072|NCT02539992|B3|Baseline|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
9073|NCT02539992|B2|Baseline|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
9074|NCT02539992|B1|Baseline|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
9075|NCT02539992|P3|Participant Flow|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
9076|NCT02539992|P2|Participant Flow|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
9077|NCT02539992|P1|Participant Flow|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
9153|NCT02539134|O6|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
11970|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
9078|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
9079|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
9080|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
9081|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
9082|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
9083|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
9084|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
9085|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
9086|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
9087|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
9088|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
9089|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
9126|NCT02539134|O4|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
9127|NCT02539134|O3|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
9091|NCT02539992|O2|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
9092|NCT02539992|O1|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
9093|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
9094|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
9095|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
9096|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
9097|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
9098|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
9099|NCT02539992|E3|Reported Event|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
9100|NCT02539992|E2|Reported Event|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
9101|NCT02539992|E1|Reported Event|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
9102|NCT02539134|B7|Baseline|Total|Total of all reporting groups
9103|NCT02539134|B6|Baseline|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
9104|NCT02539134|B5|Baseline|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
9105|NCT02539134|B4|Baseline|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
9106|NCT02539134|B3|Baseline|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
9107|NCT02539134|B2|Baseline|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
9108|NCT02539134|B1|Baseline|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
9109|NCT02539134|P6|Participant Flow|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
9110|NCT02539134|P5|Participant Flow|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
9111|NCT02539134|P4|Participant Flow|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
9112|NCT02539134|P3|Participant Flow|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
9113|NCT02539134|P2|Participant Flow|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
9114|NCT02539134|P1|Participant Flow|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
9115|NCT02539134|O5|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
9116|NCT02539134|O4|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
9117|NCT02539134|O3|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
9118|NCT02539134|O2|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
9119|NCT02539134|O1|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
9120|NCT02539134|O5|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
9121|NCT02539134|O4|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
9122|NCT02539134|O3|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
9123|NCT02539134|O2|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
9124|NCT02539134|O1|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
9125|NCT02539134|O5|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
9551|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9133|NCT02539134|O2|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
9134|NCT02539134|O1|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
9135|NCT02539134|O6|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
9136|NCT02539134|O5|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
9137|NCT02539134|O4|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
9138|NCT02539134|O3|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
9139|NCT02539134|O2|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
9140|NCT02539134|O1|Outcome|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
9141|NCT02539134|O6|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
9142|NCT02539134|O5|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
9143|NCT02539134|O4|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
9144|NCT02539134|O3|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
9145|NCT02539134|O2|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
9146|NCT02539134|O1|Outcome|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
9147|NCT02539134|O6|Outcome|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
9148|NCT02539134|O5|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
9149|NCT02539134|O4|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
9150|NCT02539134|O3|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
9151|NCT02539134|O2|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
9154|NCT02539134|O5|Outcome|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
9155|NCT02539134|O4|Outcome|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
9156|NCT02539134|O3|Outcome|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
9157|NCT02539134|O2|Outcome|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
9158|NCT02539134|O1|Outcome|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
9159|NCT02539134|E6|Reported Event|Cohort 4: TAK-935 600 mg QD|TAK-935 600 mg, solution, orally, QD for up to 10 days in Cohort 4.
9160|NCT02539134|E5|Reported Event|Cohort 5: TAK-935 400 mg QD|TAK-935 400 mg, solution, orally, QD for up to 14 days in Cohort 5.
9161|NCT02539134|E4|Reported Event|Cohort 3: TAK-935 300 mg BID|TAK-935 300 mg, solution, orally, BID for up to 10 days in Cohort 3.
9162|NCT02539134|E3|Reported Event|Cohort 2: TAK-935 300 mg QD|TAK-935 300 mg, solution, orally, QD for up to 14 days in Cohort 2.
9163|NCT02539134|E2|Reported Event|Cohort 1: TAK-935 100 mg QD|TAK-935 100 mg, solution, orally, QD for up to 14 days in Cohort 1.
9164|NCT02539134|E1|Reported Event|Cohorts 1-5: Placebo|TAK-935 placebo-matching solution, orally, QD for up to 14 days in Cohorts 1, 2, and 5; BID for up to 10 days in Cohort 3 and QD for up to 10 days in Cohort 4.
9165|NCT02539108|B3|Baseline|Total|Total of all reporting groups
9166|NCT02539108|B2|Baseline|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9167|NCT02539108|B1|Baseline|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9168|NCT02539108|P2|Participant Flow|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9169|NCT02539108|P1|Participant Flow|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9170|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9171|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9218|NCT02537522|P2|Participant Flow|Control/Test - Phase 1|Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 9.0 Base Curve in their left eye and then wore the narafilcon A with 8.5 Base Curve in their right eye.
9172|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9173|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9174|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9175|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9176|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9177|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9178|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9179|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9180|NCT02539108|E2|Reported Event|3 to <9 Years of Age|Children 3 to < 9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9181|NCT02539108|E1|Reported Event|6 to <36 Months of Age|Children 6 to < 36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
9182|NCT02538107|B1|Baseline|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9183|NCT02538107|P1|Participant Flow|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9184|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9185|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9186|NCT02538107|O2|Outcome|GFR (30-60 mL/Min)-Kidney Transplant Participants|Participants with GFR in the range of 30-60 mL/min with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9187|NCT02538107|O1|Outcome|GFR (<30 mL/Min)-Kidney Transplant Participants|Participants with GFR <30 mL/min with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9188|NCT02538107|O2|Outcome|Presence of Acute Bleeding-Kidney Transplant Participants|Participants with presence of acute bleeding episodes during the study with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9189|NCT02538107|O1|Outcome|Absence of Acute Bleeding-Kidney Transplant Participants|Participants with absence of acute bleeding episodes during the study with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9190|NCT02538107|O2|Outcome|Other Reason-Kidney Transplant Participants|Participants with unspecified other reasons as the cause of chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9191|NCT02538107|O1|Outcome|Glomerulonephritis-Kidney Transplant Participants|Participants with glomerulonephritis as the cause of chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9192|NCT02538107|O2|Outcome|Inflammatory Diseases Absent-Kidney Transplant Participants|Participants with chronic kidney disease and absence of other inflammatory diseases at baseline who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9193|NCT02538107|O1|Outcome|Inflammatory Diseases Present-Kidney Transplant Participants|Participants with chronic kidney disease and presence of other inflammatory diseases at baseline who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
20185|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
9194|NCT02538107|O2|Outcome|Cadaveric Donation-Kidney Transplant Participants|Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9195|NCT02538107|O1|Outcome|Living Donation-Kidney Transplant Participants|Participants with chronic kidney disease who underwent 'living donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9196|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9197|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9198|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9199|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9200|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9201|NCT02538107|E1|Reported Event|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
9202|NCT02537730|B1|Baseline|Overall Participants|Participants were randomized to the Bioclean MPS VII / comfilcon A combination or Aosept Clearcare / comfilcon A combination for one week, then cross over to the alternative combination.
9203|NCT02537730|P2|Participant Flow|Aosept Clearcare Combo, Then Bioclean MPS VII Combo|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week then cross over to the alternative Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination.
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A: contact lens"
9239|NCT02536664|B1|Baseline|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9204|NCT02537730|P1|Participant Flow|Bioclean MPS VII Combo, Then Aosept Clearcare Combo|"Participants were randomized to the Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination for one week, then cross over to the alternative Aosept Clearcare / comfilcon A combination
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A: contact lens"
9205|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A: contact lens"
9206|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A: contact lens"
9207|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A: contact lens"
9208|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A: contact lens"
9209|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A: contact lens"
9210|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A: contact lens"
9211|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A: contact lens"
9212|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A: contact lens"
9213|NCT02537730|E2|Reported Event|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A: contact lens"
9214|NCT02537730|E1|Reported Event|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A: contact lens"
9215|NCT02537522|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the course of the study.
9216|NCT02537522|P4|Participant Flow|Control/Test - Phase 2|Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 9.0 Base Curve in both eyes and then wore narafilcon A lens with 8.5 Base Curve in both eyes.
9217|NCT02537522|P3|Participant Flow|Test/Control - Phase 2|Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 8.5 Base Curve in both eyes and then wore narafilcon A lens with 9.0 Base Curve in both eyes.
9366|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9219|NCT02537522|P1|Participant Flow|Test/Control - Phase 1|Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 8.5 Base Curve in their left eye and then wore the narafilcon A with 9.0 Base Curve in their right eye.
9220|NCT02537522|O2|Outcome|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
9221|NCT02537522|O1|Outcome|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.
9222|NCT02537522|O2|Outcome|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
9223|NCT02537522|O1|Outcome|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.
9224|NCT02537522|E2|Reported Event|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
9225|NCT02537522|E1|Reported Event|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.
9226|NCT02536781|B3|Baseline|Total|Total of all reporting groups
9227|NCT02536781|B2|Baseline|Anthocynin|"Anthocyanin gel
Placebo: Blank gel"
9228|NCT02536781|B1|Baseline|Placebol|"Blank gel
Anthocyanin: Anti-inflammation gel"
9229|NCT02536781|P2|Participant Flow|Anthocynin|Mucoadhesive gel containing 10% of anthocyanin complex. Apply 2 times daily (Morning and night)
9230|NCT02536781|P1|Participant Flow|Placebo|Mucoadhesive gel without any drug or treatment. Apply 2 time daily (Morning and Night)
9231|NCT02536781|O2|Outcome|Anthocynin|"Anthocyanin gel
Placebo: Blank gel"
9232|NCT02536781|O1|Outcome|Placebol|"Blank gel
Anthocyanin: Anti-inflammation gel"
9233|NCT02536781|O2|Outcome|Anthocynin|"Anthocyanin gel
Placebo: Blank gel"
9234|NCT02536781|O1|Outcome|Placebol|"Blank gel
Anthocyanin: Anti-inflammation gel"
9235|NCT02536781|E2|Reported Event|Anthocynin|"Anthocyanin gel
Anti-inflammation gel"
9236|NCT02536781|E1|Reported Event|Placebol|"Placebo gel
Placebo gel"
9237|NCT02536664|B3|Baseline|Total|Total of all reporting groups
9238|NCT02536664|B2|Baseline|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9240|NCT02536664|P2|Participant Flow|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9241|NCT02536664|P1|Participant Flow|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the cluster of differentiation (CD) 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9242|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9243|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9244|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9245|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9246|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9247|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9248|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9249|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9250|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9251|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9252|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9253|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9254|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9255|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9256|NCT02536664|E2|Reported Event|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9257|NCT02536664|E1|Reported Event|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9258|NCT02535741|B1|Baseline|Triathlon CR Total Knee System|Progressive data: Primary total knee replacement
9259|NCT02535741|P1|Participant Flow|Triathlon CR Total Knee System|"Primary total knee replacement
Triathlon CR Total Knee System: Primary total knee replacement"
9260|NCT02535741|O1|Outcome|Triathlon CR Total Knee System|Prospective data of the Triathlon CR primary total knee replacement
9261|NCT02535741|E1|Reported Event|Triathlon CR Total Knee System|Triathlon CR Primary total knee replacement
9262|NCT02535026|B1|Baseline|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
9263|NCT02535026|P1|Participant Flow|Breast Cancer (BC) Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
9264|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
9265|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
9266|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
9398|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9267|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
9268|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
9269|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
9270|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
9271|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
9272|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
9273|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
9274|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
9275|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
9276|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
9277|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
9278|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
9279|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
9367|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
20186|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
9280|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
9281|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
9282|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
9283|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
9284|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
9285|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
9286|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
9287|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
9288|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
9289|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
9399|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
21181|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9290|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
9291|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
9292|NCT02535026|O2|Outcome|Breast Cancer Participants (HER2+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2+ status were included in this group.
9293|NCT02535026|O1|Outcome|Breast Cancer Participants (HER2-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2- status were included in this group.
9294|NCT02535026|O2|Outcome|Breast Cancer Participants (HER2+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2+ status were included in this group.
9295|NCT02535026|O1|Outcome|Breast Cancer Participants (HER2-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2- status were included in this group.
9296|NCT02535026|O2|Outcome|Breast Cancer Participants (HER2+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2+ status were included in this group.
9297|NCT02535026|O1|Outcome|Breast Cancer Participants (HER2-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2- status were included in this group.
9298|NCT02535026|O2|Outcome|Breast Cancer Participants (PR+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR+ status were included in this group.
9299|NCT02535026|O1|Outcome|Breast Cancer Participants (PR-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR- status were included in this group.
9300|NCT02535026|O2|Outcome|Breast Cancer Participants (PR+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR+ status were included in this group.
9301|NCT02535026|O1|Outcome|Breast Cancer Participants (PR-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR- status were included in this group.
9302|NCT02535026|O2|Outcome|Breast Cancer Participants (PR+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR+ status were included in this group.
9303|NCT02535026|O1|Outcome|Breast Cancer Participants (PR-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR- status were included in this group.
9368|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9369|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9304|NCT02535026|O2|Outcome|Breast Cancer Participants (ER+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
9305|NCT02535026|O1|Outcome|Breast Cancer Participants (ER-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER- status were included in this group.
9306|NCT02535026|O2|Outcome|Breast Cancer Participants (ER+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
9307|NCT02535026|O1|Outcome|Breast Cancer Participants (ER-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER- status were included in this group.
9308|NCT02535026|O2|Outcome|Breast Cancer Participants (ER+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
9309|NCT02535026|O1|Outcome|Breast Cancer Participants (ER-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER- status were included in this group.
9310|NCT02535026|O1|Outcome|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
9311|NCT02535026|O1|Outcome|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
9312|NCT02535026|O1|Outcome|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
9313|NCT02535026|E1|Reported Event|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
9314|NCT02534324|B3|Baseline|Total|Total of all reporting groups
11971|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
9315|NCT02534324|B2|Baseline|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9316|NCT02534324|B1|Baseline|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9317|NCT02534324|P2|Participant Flow|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9318|NCT02534324|P1|Participant Flow|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9319|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9320|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9321|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9322|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9323|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9370|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9324|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9325|NCT02534324|E2|Reported Event|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9326|NCT02534324|E1|Reported Event|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg
Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9327|NCT02533466|B3|Baseline|Total|Total of all reporting groups
9328|NCT02533466|B2|Baseline|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
9329|NCT02533466|B1|Baseline|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush and swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9330|NCT02533466|P2|Participant Flow|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9331|NCT02533466|P1|Participant Flow|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9400|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9332|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
9333|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
9334|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
9335|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
9336|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9337|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9338|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9339|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9340|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9341|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9342|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9343|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9344|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9371|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
9372|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9345|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9346|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9347|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9348|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9349|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9350|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9351|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9352|NCT02533466|E2|Reported Event|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9401|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9402|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9353|NCT02533466|E1|Reported Event|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
9354|NCT02533401|B1|Baseline|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
9355|NCT02533401|P1|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via intravenous (IV) infusion as 375 milligrams per meter-squared (mg/m^2) on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
9356|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
9357|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
9358|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
9359|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
9360|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
9361|NCT02533401|E1|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
9362|NCT02532998|B1|Baseline|All Particpants|Twenty three healthy male participants aged 18 to 50 years who satisfied all the study inclusion criteria were included in the study
9363|NCT02532998|P1|Participant Flow|All Particpants|Twenty three healthy male participants aged 18 to 50 years who satisfied all the study inclusion criteria were included in the study
9364|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9365|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
20187|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
9376|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9377|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9378|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9379|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
9380|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9381|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9382|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9383|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
9384|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9385|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9386|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9387|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
9388|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9389|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9390|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9391|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
9392|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9393|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9394|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9395|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
9396|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9397|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9404|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9405|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9406|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9407|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
9408|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9409|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
9410|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9411|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9412|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9413|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9414|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9415|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9416|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9417|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9418|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9419|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9420|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9421|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9422|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9423|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9424|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9425|NCT02532998|O1|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9426|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9427|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9428|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9429|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9430|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9431|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9432|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9433|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9434|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9435|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9436|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
9437|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9438|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9439|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9440|NCT02532998|E4|Reported Event|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
9441|NCT02532998|E3|Reported Event|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
9442|NCT02532998|E2|Reported Event|Treatment B|Participants received fludrocortisone + AZD9977
9443|NCT02532998|E1|Reported Event|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
9444|NCT02532374|B1|Baseline|Nicorette® Inhalator Then P3L|"Each subject will use the Nicorette® inhalator (15 mg) on Visit 3, and then use the P3L aerosol at nicotine dose levels of approximately 50 µg/puff, 80 µg/puff and 150 µg/puff on Visits 4, 5 and 6, respectively.
Nicorette® inhalator: Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
P3L: Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total)."
9445|NCT02532374|P1|Participant Flow|Nicorette® Inhalator Then P3L|"Each subject will use the Nicorette® inhalator (15 mg) on Visit 3, and then use the P3L aerosol at nicotine dose levels of approximately 50 µg/puff, 80 µg/puff and 150 µg/puff on Visits 4, 5 and 6, respectively.
Nicorette® inhalator: Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
P3L: Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total)."
9446|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9447|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9448|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9449|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
9450|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9451|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9452|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9453|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
9454|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9455|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9456|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9457|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
9458|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9459|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9460|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9461|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
9462|NCT02532374|E6|Reported Event|Safety Follow-up Period|All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator entered a 7-day safety follow-up period during which (serious) adverse events can be spontaneously reported by the subjects.
9463|NCT02532374|E5|Reported Event|P3L 150 µg/Puff Period|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9464|NCT02532374|E4|Reported Event|P3L 80 µg/Puff Period|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9465|NCT02532374|E3|Reported Event|P3L 50 µg/Puff Period|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
9466|NCT02532374|E2|Reported Event|Nicorette® Inhalator Period|Subjects inhaled the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
9467|NCT02532374|E1|Reported Event|Enrolment Period|"All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator.
Product test period - from enrolment to admission."
9468|NCT02531867|B1|Baseline|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
9503|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush
Toothbrushing with manual toothbrush"
9469|NCT02531867|P1|Participant Flow|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
9470|NCT02531867|O1|Outcome|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
9471|NCT02531867|E1|Reported Event|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
9472|NCT02531646|B4|Baseline|Total|Total of all reporting groups
9473|NCT02531646|B3|Baseline|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9474|NCT02531646|B2|Baseline|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9475|NCT02531646|B1|Baseline|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9476|NCT02531646|P3|Participant Flow|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9824|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
9477|NCT02531646|P2|Participant Flow|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9478|NCT02531646|P1|Participant Flow|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9479|NCT02531646|O1|Outcome|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9480|NCT02531646|O1|Outcome|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9481|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9482|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9483|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9484|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9504|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush
Toothbrushing with power toothbrush"
9485|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9486|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9487|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9488|NCT02531646|E3|Reported Event|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9489|NCT02531646|E2|Reported Event|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9518|NCT02530450|P1|Participant Flow|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
9490|NCT02531646|E1|Reported Event|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
9491|NCT02531308|B1|Baseline|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.
Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study."
9492|NCT02531308|P1|Participant Flow|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.
Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.
Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.
Rituximab: monoclonal antibody against protein CD20
Cyclophosphamide: Interferes with DNA replication
Doxorubicin: anthracycline antitumor antibiotic
Vincristine: Inhibits cell mitosis causing cell death.
Prednisone: a synthetic cortic"
9493|NCT02531308|O1|Outcome|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.
Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study."
9494|NCT02531308|E1|Reported Event|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.
Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.
Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.
Rituximab: monoclonal antibody against protein CD20
Cyclophosphamide: Interferes with DNA replication
Doxorubicin: anthracycline antitumor antibiotic
Vincristine: Inhibits cell mitosis causing cell death.
Prednisone: a synthetic cortic"
9495|NCT02530671|B3|Baseline|Total|Total of all reporting groups
9496|NCT02530671|B2|Baseline|Power Toothbrush|"Multi-directional power toothbrush
Toothbrushing with power toothbrush"
9497|NCT02530671|B1|Baseline|Manual Toothbrush|"ADA reference manual toothbrush
Toothbrushing with manual toothbrush"
9498|NCT02530671|P2|Participant Flow|Power Toothbrush|"Multi-directional power toothbrush
Toothbrushing with power toothbrush"
9499|NCT02530671|P1|Participant Flow|Manual Toothbrush|"ADA (American Dental Association) reference manual toothbrush
Toothbrushing with manual toothbrush"
9500|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush
Toothbrushing with power toothbrush"
9501|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush
Toothbrushing with manual toothbrush"
9502|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush
Toothbrushing with power toothbrush"
9505|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush
Toothbrushing with manual toothbrush"
9506|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush
Toothbrushing with power toothbrush"
9507|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush
Toothbrushing with manual toothbrush"
9508|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush
Toothbrushing with power toothbrush"
9509|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush
Toothbrushing with manual toothbrush"
9510|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush
Toothbrushing with power toothbrush"
9511|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush
Toothbrushing with manual toothbrush"
9512|NCT02530671|E2|Reported Event|Power Toothbrush|"Multi-directional power toothbrush
Toothbrushing with power toothbrush"
9513|NCT02530671|E1|Reported Event|Manual Toothbrush|"ADA reference manual toothbrush
Toothbrushing with manual toothbrush"
9514|NCT02530450|B3|Baseline|Total|Total of all reporting groups
9515|NCT02530450|B2|Baseline|Group 2|"Never blinded to continuous glucose monitoring data
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
9516|NCT02530450|B1|Baseline|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
9517|NCT02530450|P2|Participant Flow|Group 2|"Never blinded to continuous glucose monitoring data
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
9736|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone"
9519|NCT02530450|O2|Outcome|Group 2|"Never blinded to continuous glucose monitoring data
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
9520|NCT02530450|O1|Outcome|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
9521|NCT02530450|E2|Reported Event|Group 2|"Never blinded to continuous glucose monitoring data
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
9522|NCT02530450|E1|Reported Event|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
9523|NCT02529995|B3|Baseline|Total|Total of all reporting groups
9524|NCT02529995|B2|Baseline|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9525|NCT02529995|B1|Baseline|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9526|NCT02529995|P2|Participant Flow|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9527|NCT02529995|P1|Participant Flow|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9528|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9529|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9530|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9531|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9532|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9533|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9534|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9535|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9536|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9537|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9538|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9539|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9540|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9541|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9542|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9543|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9544|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9545|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9546|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9547|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9552|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9553|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9554|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9555|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9556|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9557|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9558|NCT02529995|E2|Reported Event|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
9559|NCT02529995|E1|Reported Event|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
9560|NCT02528721|B3|Baseline|Total|Total of all reporting groups
9561|NCT02528721|B2|Baseline|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9562|NCT02528721|B1|Baseline|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9563|NCT02528721|P2|Participant Flow|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9564|NCT02528721|P1|Participant Flow|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9565|NCT02528721|O2|Outcome|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9566|NCT02528721|O1|Outcome|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9567|NCT02528721|O2|Outcome|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9568|NCT02528721|O1|Outcome|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9569|NCT02528721|O2|Outcome|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9570|NCT02528721|O1|Outcome|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9571|NCT02528721|E2|Reported Event|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9572|NCT02528721|E1|Reported Event|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection
Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
9573|NCT02528331|B1|Baseline|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation
Cognitive behavioral therapy"
9574|NCT02528331|P1|Participant Flow|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation
Cognitive behavioral therapy"
9575|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation
Cognitive behavioral therapy"
9576|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation
Cognitive behavioral therapy"
9577|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation
Cognitive behavioral therapy"
9578|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation
Cognitive behavioral therapy"
9579|NCT02528331|E1|Reported Event|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation
Cognitive behavioral therapy"
9580|NCT02528097|B3|Baseline|Total|Total of all reporting groups
9581|NCT02528097|B2|Baseline|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.
Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
9582|NCT02528097|B1|Baseline|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
9583|NCT02528097|P2|Participant Flow|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.
Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
9584|NCT02528097|P1|Participant Flow|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
9585|NCT02528097|O2|Outcome|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.
Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
9586|NCT02528097|O1|Outcome|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
9587|NCT02528097|O2|Outcome|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.
Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
9588|NCT02528097|O1|Outcome|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
9589|NCT02528097|E2|Reported Event|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.
Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
9590|NCT02528097|E1|Reported Event|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
11220|NCT02488980|E1|Reported Event|Placebo|"Placebo
Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
9591|NCT02527161|B1|Baseline|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9592|NCT02527161|P1|Participant Flow|ShapeMatch® Cutting Guides With Triathlon®|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9593|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9594|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9595|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9596|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9597|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9598|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9599|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9600|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9601|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9602|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9603|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9604|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9605|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9606|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9607|NCT02527161|E1|Reported Event|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
9608|NCT02527148|B3|Baseline|Total|Total of all reporting groups
9609|NCT02527148|B2|Baseline|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
9610|NCT02527148|B1|Baseline|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
9611|NCT02527148|P2|Participant Flow|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
9612|NCT02527148|P1|Participant Flow|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
9613|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
9614|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
9615|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
9616|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
9617|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
9618|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
9619|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
9620|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
9621|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
9622|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
9623|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
9941|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9624|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
9625|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
9626|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
9627|NCT02527148|E2|Reported Event|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
9628|NCT02527148|E1|Reported Event|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
9629|NCT02526550|B1|Baseline|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
9630|NCT02526550|P1|Participant Flow|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
9631|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
9632|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
9633|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
9812|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
9634|NCT02526550|E1|Reported Event|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
9635|NCT02525536|B4|Baseline|Total|Total of all reporting groups
9636|NCT02525536|B3|Baseline|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9637|NCT02525536|B2|Baseline|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9638|NCT02525536|B1|Baseline|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9639|NCT02525536|P3|Participant Flow|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9640|NCT02525536|P2|Participant Flow|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11221|NCT02488317|B3|Baseline|Total|Total of all reporting groups
21182|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9641|NCT02525536|P1|Participant Flow|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9642|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9643|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9644|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9645|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9646|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9647|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9648|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9649|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9650|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9651|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9652|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9653|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9654|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9655|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9656|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9657|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9658|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9659|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9660|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9661|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
11391|NCT02484898|B1|Baseline|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
9662|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9663|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9664|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9665|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9666|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9667|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9668|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9669|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9670|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9671|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9672|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9673|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9674|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9675|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
10504|NCT02500836|O2|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
9676|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9677|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9678|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9679|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9680|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9681|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9682|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9683|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9684|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9685|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9686|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9687|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9688|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9689|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9690|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9691|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9692|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9693|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9694|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9695|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9696|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
10505|NCT02500836|O1|Outcome|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
9697|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9698|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9699|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9700|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9701|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9702|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9703|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9704|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9705|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9706|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9707|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9708|NCT02525536|E3|Reported Event|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9709|NCT02525536|E2|Reported Event|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9710|NCT02525536|E1|Reported Event|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
9711|NCT02524665|B1|Baseline|MAXCLARITY II + Murad|MAXCLARITY II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MAXCLARITY II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
9712|NCT02524665|P1|Participant Flow|MAXCLARITY II + Murad|MaxClarity II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MaxClarity II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
9713|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
9714|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
9715|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
9716|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
9717|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
9718|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
9821|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
9719|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
9720|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
9721|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
9722|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
9723|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
9724|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
9725|NCT02524665|E1|Reported Event|MAXCLARITY II + Murad|MAXCLARITY II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MAXCLARITY II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
9726|NCT02524561|B4|Baseline|Total|Total of all reporting groups
9727|NCT02524561|B3|Baseline|Placebo|"Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone"
9728|NCT02524561|B2|Baseline|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet"
9729|NCT02524561|B1|Baseline|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch"
9730|NCT02524561|P3|Participant Flow|Placebo|"Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone"
9731|NCT02524561|P2|Participant Flow|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet"
9732|NCT02524561|P1|Participant Flow|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch"
9733|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone"
9734|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet"
9735|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch"
9942|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9737|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet"
9738|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch"
9739|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone"
9740|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet"
9741|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch"
9742|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone"
9743|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet"
9744|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch"
9745|NCT02524561|E3|Reported Event|Placebo|"Placebo tablet, placebo patch, placebo progesterone
Placebo tablet: Placebo tablet
Placebo patch: placebo patch
Placebo progesterone: placebo progesterone"
9746|NCT02524561|E2|Reported Event|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Estradiol patch: Climara 50 mcg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo tablet: Placebo tablet"
9747|NCT02524561|E1|Reported Event|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
CEE pill: Conjugated equine estrogens 0.45 mg/day
Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Placebo patch: placebo patch"
9748|NCT02524418|B1|Baseline|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
9749|NCT02524418|P1|Participant Flow|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
20188|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
9750|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
9751|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
9752|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
9753|NCT02524418|O2|Outcome|Pancreatoscopy|Subject who had a Pancreatoscopy as part of their ERCP
9754|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
9755|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
9822|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
11972|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
9756|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
9757|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
9758|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
9759|NCT02524418|O2|Outcome|Pancreatoscopy|These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
9760|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
9761|NCT02524418|E1|Reported Event|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.
Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
9762|NCT02522624|B3|Baseline|Total|Total of all reporting groups
9763|NCT02522624|B2|Baseline|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
9764|NCT02522624|B1|Baseline|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
9765|NCT02522624|P2|Participant Flow|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
9766|NCT02522624|P1|Participant Flow|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
9767|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
9768|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
9769|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
9770|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
9771|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
9772|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
9773|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
10506|NCT02500836|O2|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
9774|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
9775|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
9776|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
9777|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
9778|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
9779|NCT02522624|E2|Reported Event|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
9823|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
9780|NCT02522624|E1|Reported Event|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
9781|NCT02520414|B1|Baseline|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
Symphion® Bipolar Hysteroscopic Tissue Resection System"
9782|NCT02520414|P1|Participant Flow|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
Symphion® Bipolar Hysteroscopic Tissue Resection System"
9783|NCT02520414|O1|Outcome|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
Symphion® Bipolar Hysteroscopic Tissue Resection System"
9784|NCT02520414|E1|Reported Event|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
Symphion® Bipolar Hysteroscopic Tissue Resection System"
9785|NCT02519855|B3|Baseline|Total|Total of all reporting groups
9786|NCT02519855|B2|Baseline|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
9787|NCT02519855|B1|Baseline|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
9788|NCT02519855|P2|Participant Flow|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
9789|NCT02519855|P1|Participant Flow|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
9790|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
9791|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
9792|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
9793|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
9794|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
9795|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
9796|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
9797|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
9798|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
9799|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
9800|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
9801|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
9802|NCT02519855|E2|Reported Event|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
9803|NCT02519855|E1|Reported Event|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
9804|NCT02519595|B4|Baseline|Total|Total of all reporting groups
9805|NCT02519595|B3|Baseline|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
9806|NCT02519595|B2|Baseline|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
9807|NCT02519595|B1|Baseline|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
9808|NCT02519595|P3|Participant Flow|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
9809|NCT02519595|P2|Participant Flow|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
9810|NCT02519595|P1|Participant Flow|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
9811|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
10507|NCT02500836|O1|Outcome|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
9813|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
9814|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
9815|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
9816|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
9817|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
9818|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
9819|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
9820|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
9943|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9825|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
9826|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
9827|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
9828|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
9829|NCT02519595|E3|Reported Event|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
9830|NCT02519595|E2|Reported Event|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
9831|NCT02519595|E1|Reported Event|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
9832|NCT02519387|B1|Baseline|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Buprenorphine Transdermal Patch"
9833|NCT02519387|P1|Participant Flow|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Buprenorphine Transdermal Patch"
9834|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Buprenorphine Transdermal Patch"
9835|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Buprenorphine Transdermal Patch"
9836|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Buprenorphine Transdermal Patch"
9837|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Buprenorphine Transdermal Patch"
9838|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Buprenorphine Transdermal Patch"
9839|NCT02519387|E1|Reported Event|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Buprenorphine Transdermal Patch"
9840|NCT02518048|B1|Baseline|All Study Participants|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam
Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg"
9841|NCT02518048|P1|Participant Flow|LEO 90100 Aerosol Foam; Betesil® 2.25 mg|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam
Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg"
9842|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg"
9843|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam"
9844|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg"
9845|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam"
9846|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg"
9847|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam"
11784|NCT02482129|E2|Reported Event|LME636|All subjects exposed to LME636 ophthalmic solution
9848|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg"
9849|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam"
9850|NCT02518048|E1|Reported Event|All Subjects|All subjects received both medication and reporting is on the entire population.
9851|NCT02516306|B3|Baseline|Total|Total of all reporting groups
9852|NCT02516306|B2|Baseline|Placebo|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days.
9853|NCT02516306|B1|Baseline|EV06 Ophthalmic Solution|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days.
9854|NCT02516306|P2|Participant Flow|Placebo|Placebo Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye. Day 8 - 91 one drop administered twice per day in both eyes.
9855|NCT02516306|P1|Participant Flow|EVO6 Ophthalmic Solution|EV06 Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye; Day 8 - 91 one drop twice per day in both eyes.
9856|NCT02516306|O2|Outcome|Placebo Ophthalmic Solution|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day in one eye; Period 2 (Day 8 - 91) one drop twice per day in both eyes.
9857|NCT02516306|O1|Outcome|EVO6 Ophthalmic Solution|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day in one eye; Period 2 (Day 8 - 91) one drop twice per day in both eyes.
9858|NCT02516306|E2|Reported Event|Placebo|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes.
9859|NCT02516306|E1|Reported Event|EVO6|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes.
21183|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9860|NCT02516163|B1|Baseline|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.
They are intended for single use only."
9861|NCT02516163|P1|Participant Flow|Shapematch Cutting Guides|The ShapeMatch® Cutting Guides are patient-specific surgical instruments to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.They are single use only. Participants undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology is implemented in which the position of the femoral and tibial cutting guides is measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and instruments. No post-operative evaluations will be undertaken as part of this sub-study.
9862|NCT02516163|O1|Outcome|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.
They are intended for single use only."
9863|NCT02516163|E1|Reported Event|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.
They are intended for single use only.
Shapematch Cutting Guides: Participants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system instruments. No post-operative evaluations will be undertaken as part of this sub-study"
9864|NCT02516150|B1|Baseline|All Subjects|All subjects enrolled
9865|NCT02516150|P1|Participant Flow|All Subjects|All subjects enrolled
9866|NCT02516150|O2|Outcome|Glucagon Without Ethanol|"Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.
Glucagon: injection of 50 micrograms of glucagon"
9867|NCT02516150|O1|Outcome|Glucagon With Ethanol|"Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.
Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%
Glucagon: injection of 50 micrograms of glucagon"
9868|NCT02516150|O2|Outcome|Glucagon Without Ethanol|"Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.
Glucagon: injection of 50 micrograms of glucagon"
9869|NCT02516150|O1|Outcome|Glucagon With Ethanol|"Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.
Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%
Glucagon: injection of 50 micrograms of glucagon"
9870|NCT02516150|E2|Reported Event|Glucagon Without Ethanol|"Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.
Glucagon: injection of 50 micrograms of glucagon"
9871|NCT02516150|E1|Reported Event|Glucagon With Ethanol|"Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.
Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%
Glucagon: injection of 50 micrograms of glucagon"
9872|NCT02516098|B3|Baseline|Total|Total of all reporting groups
9930|NCT02513095|P1|Participant Flow|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.
Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
9873|NCT02516098|B2|Baseline|T-REF|"The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days.
All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
9874|NCT02516098|B1|Baseline|REF-T|"The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days.
All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
9875|NCT02516098|P2|Participant Flow|T-REF|"The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days.
All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
9876|NCT02516098|P1|Participant Flow|REF-T|"The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days.
All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
9877|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
9944|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9878|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
9879|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
9880|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
9881|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
9882|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
9883|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
9884|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
9885|NCT02516098|E2|Reported Event|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
9886|NCT02516098|E1|Reported Event|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
9887|NCT02515994|B3|Baseline|Total|Total of all reporting groups
9888|NCT02515994|B2|Baseline|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9889|NCT02515994|B1|Baseline|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9890|NCT02515994|P2|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9891|NCT02515994|P1|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9892|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
9893|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
9894|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
9895|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
9896|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
9897|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
9898|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
9899|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
9900|NCT02515994|E2|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
9901|NCT02515994|E1|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
9902|NCT02515279|B1|Baseline|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
10508|NCT02500836|E3|Reported Event|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
9903|NCT02515279|P1|Participant Flow|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
9904|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
9905|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
9906|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
9907|NCT02515279|E1|Reported Event|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
9908|NCT02515045|B3|Baseline|Total|Total of all reporting groups
9909|NCT02515045|B2|Baseline|TriMoxiVanc + Ilevro One Eye + Control Fellow Eye|"Subject's eyes were randomized to either TriMoxiVan + Ilevro or Control group.
TriMoxiVan + Ilevro group:
Nepafenac ophthalmic suspension 0.3% started 3 days prior to surgery QD and continued QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco (triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml ) injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
Control group:
Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued.
Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
9910|NCT02515045|B1|Baseline|TriMoxiVanc One Eye + Control Fellow Eye|"Subject's eyes were randomized to either TriMoxiVan or Control group.
TriMoxiVanc group:
Triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml used as an injection delivered into the vitreous cavity using a transzonular approach at the end of the uneventful phacoemulsification procedure after IOL implantation before removal of the OVD.
Control group:
Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued.
Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
9911|NCT02515045|P3|Participant Flow|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
9912|NCT02515045|P2|Participant Flow|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
9913|NCT02515045|P1|Participant Flow|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
9914|NCT02515045|O3|Outcome|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
9931|NCT02513095|O2|Outcome|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
10167|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
9915|NCT02515045|O2|Outcome|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
9916|NCT02515045|O1|Outcome|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
9917|NCT02515045|O3|Outcome|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
9945|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9946|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
21184|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9918|NCT02515045|O2|Outcome|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
9919|NCT02515045|O1|Outcome|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
9920|NCT02515045|O3|Outcome|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
9921|NCT02515045|O2|Outcome|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
9922|NCT02515045|O1|Outcome|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
9923|NCT02515045|E3|Reported Event|Control|"Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued."
9924|NCT02515045|E2|Reported Event|TriMoxiVanc + Ilevro|"Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery."
9925|NCT02515045|E1|Reported Event|TriMoxiVanc|"The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery."
9926|NCT02513095|B3|Baseline|Total|Total of all reporting groups
9927|NCT02513095|B2|Baseline|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
9928|NCT02513095|B1|Baseline|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.
Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
9929|NCT02513095|P2|Participant Flow|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
10168|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
9932|NCT02513095|O1|Outcome|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.
Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
9933|NCT02513095|E2|Reported Event|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
9934|NCT02513095|E1|Reported Event|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.
Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
9935|NCT02512900|B3|Baseline|TOTAL|Total of all reporting groups
9936|NCT02512900|B2|Baseline|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9937|NCT02512900|B1|Baseline|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9938|NCT02512900|P2|Participant Flow|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9939|NCT02512900|P1|Participant Flow|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9940|NCT02512900|O1|Outcome|MEDI9929|On Day 1, a single dose of MEDI9929 was administered subcutaneously to participants, aged 12 to 17 years, inclusive.
21185|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9947|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9948|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9949|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9950|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9951|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9952|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9953|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9954|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9955|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9956|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9957|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9958|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9959|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9960|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9961|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9962|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9963|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9964|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9965|NCT02512900|O2|Outcome|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9966|NCT02512900|O1|Outcome|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9967|NCT02512900|E2|Reported Event|MEDI9929, 140 mg, (15 to 17 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9968|NCT02512900|E1|Reported Event|MEDI9929, 140 mg, (12 to 14 Years)|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
9969|NCT02512783|B3|Baseline|Total|Total of all reporting groups
9970|NCT02512783|B2|Baseline|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.
Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation
Propofol: Intravenous administration of propofol according to standard care to sedate patient."
9971|NCT02512783|B1|Baseline|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.
Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation
Propofol: Intravenous administration of propofol according to standard care to sedate patient."
9972|NCT02512783|P2|Participant Flow|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.
Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation
Propofol: Intravenous administration of propofol according to standard care to sedate patient."
9973|NCT02512783|P1|Participant Flow|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.
Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation
Propofol: Intravenous administration of propofol according to standard care to sedate patient."
9974|NCT02512783|O2|Outcome|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.
Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation
Propofol: Intravenous administration of propofol according to standard care to sedate patient."
9975|NCT02512783|O1|Outcome|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.
Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation
Propofol: Intravenous administration of propofol according to standard care to sedate patient."
9976|NCT02512783|O2|Outcome|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.
Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation
Propofol: Intravenous administration of propofol according to standard care to sedate patient."
9977|NCT02512783|O1|Outcome|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.
Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation
Propofol: Intravenous administration of propofol according to standard care to sedate patient."
9978|NCT02512783|E2|Reported Event|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.
Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation
Propofol: Intravenous administration of propofol according to standard care to sedate patient."
9979|NCT02512783|E1|Reported Event|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.
Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation
Propofol: Intravenous administration of propofol according to standard care to sedate patient."
9995|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
9980|NCT02512679|B1|Baseline|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.
Drug to be given in combination of Busulfan, Campath and Fludarabine
Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
9981|NCT02512679|P2|Participant Flow|Cyclophosphamide Dose Level 2|"De-escalation of Cyclophosphamide given by Intravenous (IV) at a total dose of 70 mg/kg, to be divided into two doses of one 35 mg/kg dose per day, for 2 days
Drug to be given in combination of Busulfan, Campath and Fludarabine
Cyclophosphamide Dose Level 1: given by IV at a total dose of 75 mg/kg, to be divided into two doses of one 35 mg/kg dose per day, for 2 days. After ten patients the de-escalation will begin if the stopping rule is not met."
9982|NCT02512679|P1|Participant Flow|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.
Drug to be given in combination of Busulfan, Campath and Fludarabine
Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
9983|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.
Drug to be given in combination of Busulfan, Campath and Fludarabine
Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
9984|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.
Drug to be given in combination of Busulfan, Campath and Fludarabine
Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
9985|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.
Drug to be given in combination of Busulfan, Campath and Fludarabine
Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
9986|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.
Drug to be given in combination of Busulfan, Campath and Fludarabine
Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
9987|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.
Drug to be given in combination of Busulfan, Campath and Fludarabine
Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
9988|NCT02512679|E1|Reported Event|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.
Drug to be given in combination of Busulfan, Campath and Fludarabine
Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
9989|NCT02512393|B3|Baseline|Total|Total of all reporting groups
10076|NCT02512224|P1|Participant Flow|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
9990|NCT02512393|B2|Baseline|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
9991|NCT02512393|B1|Baseline|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
9992|NCT02512393|P2|Participant Flow|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
9993|NCT02512393|P1|Participant Flow|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
9994|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10232|NCT02506881|E3|Reported Event|BCD-066 - Intravenous|Safety parameters of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg are presented.
9996|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
9997|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
9998|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
9999|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10000|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10001|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10002|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10003|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10004|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10005|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10006|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10126|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10007|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10008|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10009|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10010|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10011|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10012|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10013|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10014|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10015|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10016|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10017|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10018|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10019|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10020|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10021|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10022|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10023|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10127|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10024|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10025|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10026|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10027|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10028|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10029|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10030|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10031|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10032|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10033|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10034|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10035|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10036|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10037|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10038|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10039|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10040|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10128|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10041|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10042|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10043|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10044|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10045|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10046|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10047|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10048|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10049|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10050|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10051|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10052|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10053|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10054|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10055|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10056|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10057|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10129|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10058|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10059|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10060|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10061|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10062|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10063|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10064|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10065|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10066|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10067|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10068|NCT02512393|O2|Outcome|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10069|NCT02512393|O1|Outcome|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10070|NCT02512393|E2|Reported Event|Sham tDCS|This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10071|NCT02512393|E1|Reported Event|Active tDCS|This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
10072|NCT02512224|B3|Baseline|Total|Total of all reporting groups
10073|NCT02512224|B2|Baseline|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10074|NCT02512224|B1|Baseline|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10075|NCT02512224|P2|Participant Flow|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10130|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10077|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10078|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10079|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10080|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10081|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10082|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10139|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
11973|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
10083|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10084|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10085|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10086|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10087|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10088|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10089|NCT02512224|E2|Reported Event|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10090|NCT02512224|E1|Reported Event|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.
Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
10091|NCT02511782|B4|Baseline|Total|Total of all reporting groups
10092|NCT02511782|B3|Baseline|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10093|NCT02511782|B2|Baseline|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10131|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10132|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10169|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10094|NCT02511782|B1|Baseline|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10095|NCT02511782|P3|Participant Flow|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10140|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens Synergi: Multipurpose solution"
10233|NCT02506881|E2|Reported Event|Aranesp® Subcutaneous|Safety parameters of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg are presented.
10096|NCT02511782|P2|Participant Flow|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10097|NCT02511782|P1|Participant Flow|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10098|NCT02511782|O2|Outcome|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10099|NCT02511782|O1|Outcome|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10100|NCT02511782|O3|Outcome|Chronic Graft Versus Host Disease|This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease.
10101|NCT02511782|O2|Outcome|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10102|NCT02511782|O1|Outcome|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10166|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10103|NCT02511782|E3|Reported Event|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10104|NCT02511782|E2|Reported Event|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10141|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
11974|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
10105|NCT02511782|E1|Reported Event|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.
D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
10106|NCT02510820|B1|Baseline|Overall Baseline Characteristics|Participants were randomized to wear either the Synergi/comfilcon A or Biotrue/comfilcon A combination for one month, then cross over to the alternative combination.
10107|NCT02510820|P2|Participant Flow|Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo|Participants were randomized to wear Biotrue/comfilcon A combination for one month, then cross over to the alternative Synergi/comfilcon A combination.
10108|NCT02510820|P1|Participant Flow|Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo|Participants were randomized to wear Synergi/comfilcon A combination for one month, then cross over to the alternative Biotrue/comfilcon A combination.
10109|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10110|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10111|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10112|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10113|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10114|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10115|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10116|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10117|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10118|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10119|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10120|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10121|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10122|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10123|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10124|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10125|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10189|NCT02507375|O1|Outcome|Total Population|Erlotinib + pertuzumab
10133|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10134|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10135|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10136|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10137|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution"
10138|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10142|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution"
10143|NCT02510820|E2|Reported Event|Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
Synergi: Multipurpose solution"
10144|NCT02510820|E1|Reported Event|Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
Biotrue: Multipurpose solution"
10145|NCT02508103|B3|Baseline|Total|Total of all reporting groups
10146|NCT02508103|B2|Baseline|Placebo, Then Oxytocin|"Participants were randomized to receive Intransal Placebo for late luteal phase administration during one menstrual cycle, then received Intranasal Oxytocin for late luteal phase administration of a subsequent menstrual cycle.
Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
10147|NCT02508103|B1|Baseline|Oxytocin, Then Placebo|"Participants were randomized to receive Intransal Oxytocin for late luteal phase administration during one menstrual cycle, then received Intranasal Placebo for late luteal phase administration of a subsequent menstrual cycle.
Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
10148|NCT02508103|P2|Participant Flow|Placebo, Then Oxytocin|"Participants were randomized to receive Intransal Placebo for late luteal phase administration during one menstrual cycle, then received Oxytocin for late luteal phase administration of a subsequent menstrual cycle.
Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
10149|NCT02508103|P1|Participant Flow|Oxytocin, Then Placebo|"Participants were randomized to receive Intransal Oxytocin for late luteal phase administration during one menstrual cycle, then received Placebo for late luteal phase administration of a subsequent menstrual cycle.
Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days"
10150|NCT02508103|O2|Outcome|Placebo|Intranasal Placebo spray (3x/day) for 4-5 days
10151|NCT02508103|O1|Outcome|Oxytocin|Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days
10152|NCT02508103|O2|Outcome|Placebo|Intranasal Placebo spray (3x/day) for 4-5 days
10153|NCT02508103|O1|Outcome|Oxytocin|Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days
10154|NCT02508103|E2|Reported Event|Placebo|Intranasal Placebo spray (3x/day) for 4-5 days
10155|NCT02508103|E1|Reported Event|Oxytocin|Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days
10156|NCT02507752|B1|Baseline|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10157|NCT02507752|P1|Participant Flow|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10158|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10159|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10160|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10161|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10162|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10163|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10164|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10165|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
20189|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
10170|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10171|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10172|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10173|NCT02507752|E1|Reported Event|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
10174|NCT02507375|B3|Baseline|Total|Total of all reporting groups
10175|NCT02507375|B2|Baseline|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
10176|NCT02507375|B1|Baseline|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
10177|NCT02507375|P2|Participant Flow|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
10230|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported."
10178|NCT02507375|P1|Participant Flow|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
10179|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
10180|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
10181|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
10182|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
10183|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
10184|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
10185|NCT02507375|O2|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
10186|NCT02507375|O1|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
10187|NCT02507375|O3|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
10188|NCT02507375|O2|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
10190|NCT02507375|O2|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
10191|NCT02507375|O1|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
10192|NCT02507375|E2|Reported Event|Cohort 2|Erlotinib 150 mg + pertuzumab 420 mg
10193|NCT02507375|E1|Reported Event|Cohort 1|Erlotinib 100 mg + pertuzumab 420 mg
10194|NCT02506881|B5|Baseline|Total|Total of all reporting groups
10195|NCT02506881|B4|Baseline|Aranesp → BCD-066 - Intravenous|Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
10196|NCT02506881|B3|Baseline|BCD-066 → Aranesp - Intravenous|Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
10231|NCT02506881|E4|Reported Event|Aranesp® - Intravenous|Safety parameters of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg are presented.
11399|NCT02484729|B7|Baseline|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
10197|NCT02506881|B2|Baseline|Aranesp → BCD-066 - Subcutaneous|Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
10198|NCT02506881|B1|Baseline|BCD-066 → Aranesp - Subcutaneous|Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
10199|NCT02506881|P4|Participant Flow|Aranesp → BCD-066 - Intravenous|"Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa"
10200|NCT02506881|P3|Participant Flow|BCD-066 → Aranesp - Intravenous|"Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa"
10201|NCT02506881|P2|Participant Flow|Aranesp → BCD-066 - Subcutaneous|"Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa"
10202|NCT02506881|P1|Participant Flow|BCD-066 → Aranesp - Subcutaneous|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa"
10203|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
10204|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
10205|NCT02506881|O2|Outcome|Aranesp® - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
10206|NCT02506881|O1|Outcome|BCD-066 - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
10207|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
10208|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
10209|NCT02506881|O2|Outcome|Aranesp® - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
10210|NCT02506881|O1|Outcome|BCD-066 - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
10211|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
10212|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
10213|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
10214|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
10215|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
10216|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
10217|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
10218|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
10219|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
10220|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
10221|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
10222|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
10223|NCT02506881|O4|Outcome|Aranesp® - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
Cmax of darbepoetin alfa 0 to 72 hours is reported."
10224|NCT02506881|O3|Outcome|BCD-066 - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
Cmax of darbepoetin alfa 0 to 72 hours is reported."
10225|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
Cmax of darbepoetin alfa 0 to 336 hours is reported."
10226|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
Cmax of darbepoetin alfa 0 to 336 hours is reported."
10227|NCT02506881|O4|Outcome|Aranesp® - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported."
10228|NCT02506881|O3|Outcome|BCD-066 - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported."
10229|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported."
21186|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
10234|NCT02506881|E1|Reported Event|BCD-066 Subcutaneous|Safety parameters of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg are presented.
10235|NCT02506309|B3|Baseline|Total|Total of all reporting groups
10236|NCT02506309|B2|Baseline|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).
TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10237|NCT02506309|B1|Baseline|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).
SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10238|NCT02506309|P2|Participant Flow|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).
TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10239|NCT02506309|P1|Participant Flow|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).
SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10240|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).
TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10241|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).
SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10242|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).
TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10243|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).
SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10244|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).
TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10245|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).
SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10296|NCT02504775|O2|Outcome|Mejoral® 500 Tablets (Test)|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
10246|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).
TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10247|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).
SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10248|NCT02506309|E2|Reported Event|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).
TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10249|NCT02506309|E1|Reported Event|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).
SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
10250|NCT02506257|B5|Baseline|Total|Total of all reporting groups
10251|NCT02506257|B4|Baseline|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10572|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10252|NCT02506257|B3|Baseline|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10253|NCT02506257|B2|Baseline|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10254|NCT02506257|B1|Baseline|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10255|NCT02506257|P4|Participant Flow|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10256|NCT02506257|P3|Participant Flow|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10257|NCT02506257|P2|Participant Flow|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10258|NCT02506257|P1|Participant Flow|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10259|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10260|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10261|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10262|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10263|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10264|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10265|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10266|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10267|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10268|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10269|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10396|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
10270|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10271|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10272|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10273|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10274|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10275|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10276|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10913|NCT02493036|O3|Outcome|Placebo/42-mg SYN-010|Subjects were on placebo in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
10277|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10278|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10279|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10280|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10281|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10282|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10283|NCT02506257|E4|Reported Event|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10284|NCT02506257|E3|Reported Event|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10285|NCT02506257|E2|Reported Event|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10286|NCT02506257|E1|Reported Event|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
10287|NCT02504775|B1|Baseline|Overall Participants|Total number of participants who were randomized and received treatment.
10288|NCT02504775|P2|Participant Flow|Mejoral® 500 Tablets (Test), Then Tylenol® Caplets (Reference)|Participants first received one tablet of Mejoral® Tablets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Tylenol® 500 Caplets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting.
10289|NCT02504775|P1|Participant Flow|Tylenol® Caplets (Reference), Then Mejoral® 500 Tablets (Test)|Participants first received one tablet of Tylenol® Caplets [500 milligram (mg) of paracetamol], orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Mejoral® 500 tablets (500 mg of paracetamol), orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting.
10290|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
10291|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
10292|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
10293|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
10294|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
10295|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
10297|NCT02504775|O1|Outcome|Tylenol® Caplets (Reference)|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
10298|NCT02504775|E2|Reported Event|Mejoral® 500 Tablets|Participants will first receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
10299|NCT02504775|E1|Reported Event|Tylenol® Caplets|Participants will first receive one tablet [500 milligram (mg) of paracetamol] of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
10300|NCT02504723|B3|Baseline|Total|Total of all reporting groups
10301|NCT02504723|B2|Baseline|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10362|NCT02503865|B1|Baseline|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy
Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
10363|NCT02503865|P3|Participant Flow|Healthy People|64 healthy people
10302|NCT02504723|B1|Baseline|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.
carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10303|NCT02504723|P2|Participant Flow|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10304|NCT02504723|P1|Participant Flow|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.
carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10305|NCT02504723|O2|Outcome|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10306|NCT02504723|O1|Outcome|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.
carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10307|NCT02504723|O2|Outcome|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10308|NCT02504723|O1|Outcome|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.
carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10309|NCT02504723|O2|Outcome|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10310|NCT02504723|O1|Outcome|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.
carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10311|NCT02504723|O2|Outcome|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10397|NCT02503254|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the CHTP 1.0 at Admission (Day -3) but were not randomized
10509|NCT02500836|E2|Reported Event|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
10312|NCT02504723|O1|Outcome|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.
carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10313|NCT02504723|E2|Reported Event|Cyanoacrylate Injection|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10364|NCT02503865|P2|Participant Flow|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication
Analimentary detoxication: Vegetable and salt diet"
10914|NCT02493036|O2|Outcome|21-mg SYN-010/42-mg SYN-010|Subjects were on 21 mg in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
10314|NCT02504723|E1|Reported Event|Cyanoacrylate Injection Plus Carvedilol|"The patients undergo repeated endoscopic cyanoacrylate injection every 3–4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.
carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.
cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices."
10315|NCT02504502|B3|Baseline|Total|Total of all reporting groups
10316|NCT02504502|B2|Baseline|Enhanced Genomic Report|"Those resulting in variants of significance will received routine clinical care and access to the enhanced genomic lab report.
Enhanced Genomic Report: Routine clinical care vs. enhanced genomic report"
10317|NCT02504502|B1|Baseline|Routine Clinical Care|"Those resulting in variants of significance will receive routine clinical care and receive the enhanced genomic report in 6 months.
Routine Clinical Care: Participants will receive routine clinical care. After 6 months the participants will also receive the enhanced genomic report."
10318|NCT02504502|P2|Participant Flow|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
10319|NCT02504502|P1|Participant Flow|Routine Clinical Care First, Then Enhanced Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
10320|NCT02504502|O2|Outcome|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
10321|NCT02504502|O1|Outcome|Routine Clinical Care First, Then Enhanced Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
10322|NCT02504502|E2|Reported Event|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
10323|NCT02504502|E1|Reported Event|Routine Clinical Care First, Then Enhanced Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
10324|NCT02504320|B5|Baseline|Total|Total of all reporting groups
10325|NCT02504320|B4|Baseline|Treatment Sequence BCAD|Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).
10326|NCT02504320|B3|Baseline|Treatment Sequence CDBA|Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).
10327|NCT02504320|B2|Baseline|Treatment Sequence DACB|Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).
10328|NCT02504320|B1|Baseline|Treatment Sequence ABDC|Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).
10329|NCT02504320|P4|Participant Flow|Treatment Sequence BCAD|Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).
10398|NCT02503254|E2|Reported Event|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
10399|NCT02503254|E1|Reported Event|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
10330|NCT02504320|P3|Participant Flow|Treatment Sequence CDBA|Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).
10331|NCT02504320|P2|Participant Flow|Treatment Sequence DACB|Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).
10942|NCT02492841|B4|Baseline|Total|Total of all reporting groups
10332|NCT02504320|P1|Participant Flow|Treatment Sequence ABDC|Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).
10333|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
10334|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
10335|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
10336|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
10337|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
10338|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
10339|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
10340|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
10341|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
10342|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
10343|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
10344|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
10345|NCT02504320|E4|Reported Event|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
10346|NCT02504320|E3|Reported Event|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
10347|NCT02504320|E2|Reported Event|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
10348|NCT02504320|E1|Reported Event|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
10349|NCT02504073|B1|Baseline|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
10350|NCT02504073|P1|Participant Flow|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
10351|NCT02504073|O1|Outcome|PT's Working in Stroke in NW-Switzerland|"54 Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach are asked to analyse videos of 6 hemiplegic patients when walking. They are asked to write down their main observations, the major problem and hypotheses about how this major problem is produced.
There is no intervention.
No intervention: No intervention"
10352|NCT02504073|O1|Outcome|PT's Working in Stroke in NW-Switzerland|"54 Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach are asked to analyse videos of 6 hemiplegic patients when walking. They are asked to write down their main observations, the major problem and hypotheses about how this major problem is produced.
There is no intervention.
No intervention: No intervention"
10353|NCT02504073|O1|Outcome|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
10354|NCT02504073|E1|Reported Event|PT's Working With Stroke Patients in NW-Switzerland|Physiotherapists from Bruderholzspital, RehaB Basel, Klinik Tschugg, Reha Rheinfelden, RehaClinic Zurzach
10355|NCT02503982|B1|Baseline|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.
prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
10356|NCT02503982|P1|Participant Flow|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.
prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
10357|NCT02503982|O1|Outcome|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.
prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
10498|NCT02500836|B3|Baseline|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
10358|NCT02503982|E1|Reported Event|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.
prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
10359|NCT02503865|B4|Baseline|Total|Total of all reporting groups
10360|NCT02503865|B3|Baseline|Healthy People|64 healthy people
10361|NCT02503865|B2|Baseline|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication
Analimentary detoxication: Vegetable and salt diet"
10573|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10365|NCT02503865|P1|Participant Flow|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy
Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
10366|NCT02503865|O3|Outcome|Healthy People|64 healthy people
10367|NCT02503865|O2|Outcome|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication
Analimentary detoxication: Vegetable and salt diet"
10368|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy
Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
10369|NCT02503865|O3|Outcome|Healthy People|64 healthy people
10370|NCT02503865|O2|Outcome|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication
Analimentary detoxication: Vegetable and salt diet"
10371|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy
Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
10372|NCT02503865|O3|Outcome|Healthy People|64 healthy people
10373|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication
Analimentary detoxication: Vegetable and salt diet"
10374|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy
Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
10375|NCT02503865|O3|Outcome|Healthy People|64 healthy people
10376|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication
Analimentary detoxication: Vegetable and salt diet"
10377|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy
Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
10378|NCT02503865|O3|Outcome|Healthy People|64 healthy people
10379|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication
Analimentary detoxication: Vegetable and salt diet"
10380|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy
Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
10381|NCT02503865|E3|Reported Event|Healthy People|64 healthy people
10382|NCT02503865|E2|Reported Event|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication
Analimentary detoxication: Vegetable and salt diet"
10383|NCT02503865|E1|Reported Event|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy
Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
10384|NCT02503254|B3|Baseline|Total|Total of all reporting groups
10385|NCT02503254|B2|Baseline|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
10386|NCT02503254|B1|Baseline|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
10387|NCT02503254|P2|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
10388|NCT02503254|P1|Participant Flow|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
10389|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
10390|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
10391|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
10392|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
10393|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
10394|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
10395|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
10400|NCT02503215|B1|Baseline|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance
Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
10401|NCT02503215|P1|Participant Flow|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance
Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
10402|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance
Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
10403|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance
Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
10404|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance
Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
10405|NCT02503215|E1|Reported Event|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance
Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
10406|NCT02502734|B1|Baseline|Fluticasone Furoate and Placebo in Any of the Two Sequences|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 2. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
10407|NCT02502734|P2|Participant Flow|Fluticasone Furoate Followed by Placebo|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
10408|NCT02502734|P1|Participant Flow|Placebo Followed by Fluticasone Furoate|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Treatment Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
10409|NCT02502734|O2|Outcome|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
10410|NCT02502734|O1|Outcome|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
10411|NCT02502734|O2|Outcome|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2.
10412|NCT02502734|O1|Outcome|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2.
10413|NCT02502734|E2|Reported Event|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
10414|NCT02502734|E1|Reported Event|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
10415|NCT02502487|B4|Baseline|Total|Total of all reporting groups
10416|NCT02502487|B3|Baseline|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10417|NCT02502487|B2|Baseline|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10418|NCT02502487|B1|Baseline|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10419|NCT02502487|P3|Participant Flow|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10499|NCT02500836|B2|Baseline|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
10500|NCT02500836|B1|Baseline|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
10501|NCT02500836|P3|Participant Flow|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
10420|NCT02502487|P2|Participant Flow|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10421|NCT02502487|P1|Participant Flow|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10422|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10574|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10423|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10424|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10425|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10426|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10427|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10428|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10429|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10430|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10431|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10432|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10433|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10434|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10435|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10436|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10437|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10438|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10439|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
20190|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
10440|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10441|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10442|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10443|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10444|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10445|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10446|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10447|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10448|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10449|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10450|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10451|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10452|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10453|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10454|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10455|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10456|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10457|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10458|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10502|NCT02500836|P2|Participant Flow|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
10503|NCT02500836|P1|Participant Flow|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
10459|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10460|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10461|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10462|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10463|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10464|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10465|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10466|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10467|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10468|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10469|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10470|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10471|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10472|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10473|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10474|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10475|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10476|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10477|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10478|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
12025|NCT02478671|P1|Participant Flow|TR Band|MRI based radial artery measurement
10479|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10480|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10481|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10482|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
Tetracaine: 1% Tetracaine gel instilled into urethra"
10483|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
10484|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra"
10485|NCT02502487|E3|Reported Event|Combination Group|DPNB with ropivacaine plus tetracaine gel
10486|NCT02502487|E2|Reported Event|DPNB Group|DPNB with ropivacaine plus plain lubricant
10487|NCT02502487|E1|Reported Event|Tetracaine Group|tetracaine gel plus DPNB with saline
10488|NCT02501590|B3|Baseline|Total|Total of all reporting groups
10489|NCT02501590|B2|Baseline|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.
The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
10490|NCT02501590|B1|Baseline|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.
The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
10491|NCT02501590|P2|Participant Flow|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.
The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
10492|NCT02501590|P1|Participant Flow|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.
The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
10493|NCT02501590|O2|Outcome|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.
The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
10494|NCT02501590|O1|Outcome|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.
The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
10495|NCT02501590|E2|Reported Event|Control|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.
The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
10496|NCT02501590|E1|Reported Event|Study|"After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child’s dominant hand.
The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing)."
10497|NCT02500836|B4|Baseline|Total|Total of all reporting groups
10510|NCT02500836|E1|Reported Event|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
10511|NCT02500758|B3|Baseline|Total|Total of all reporting groups
10538|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10539|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
11975|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
10512|NCT02500758|B2|Baseline|Chlorhexidine Digluconate|"Reducing bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
Preparatory handwash follows the UNE-EN 12791 standard."
10513|NCT02500758|B1|Baseline|Parachlorometaxylenol|"Reducing bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
Preparatory handwash follows the UNE-EN 12791 standard."
10514|NCT02500758|P2|Participant Flow|Chlorhexidine Digluconate Then Parachlorometaxylenol|"Participants first scrubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with chlorhexidine digluconato (matching parachlorometaxylenol).
After a washout period of 1 week, to allow reconstruction of the normal skin flora, they then scubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with parachlorometaxylenol."
10515|NCT02500758|P1|Participant Flow|Parachlorometaxylenol Then Clorhexidine Digluconate|Participants first scrubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with parachlorometaxylenol After a washout period of 1 week, to allow reconstruction of the normal skin flora, they then scubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with chlorhexidine digluconato (matching parachlorometaxylenol).
10516|NCT02500758|O2|Outcome|Chlorhexidine Digluconate|"Change in bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
Preparatory handwash follows the UNE-EN 12791 standard."
10517|NCT02500758|O1|Outcome|Parachlorometaxylenol|"Change in bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
Preparatory handwash follows the UNE-EN 12791 standard."
10518|NCT02500758|O2|Outcome|Chlorhexidine Digluconate|"Change in bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
Preparatory handwash follows the UNE-EN 12791 standard."
10519|NCT02500758|O1|Outcome|Parachlorometaxylenol|"Change in bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
Preparatory handwash follows the UNE-EN 12791 standard"
10537|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10567|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10571|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10520|NCT02500758|E2|Reported Event|Chlorhexidine Digluconate|"Reducing bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
Preparatory handwash follows the UNE-EN 12791 standard."
10521|NCT02500758|E1|Reported Event|Parachlorometaxylenol|"Reducing bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
Preparatory handwash follows the UNE-EN 12791 standard."
10522|NCT02500537|B3|Baseline|Total|Total of all reporting groups
10523|NCT02500537|B2|Baseline|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10524|NCT02500537|B1|Baseline|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10525|NCT02500537|P2|Participant Flow|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10526|NCT02500537|P1|Participant Flow|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10527|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10528|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10529|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10530|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10531|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10532|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10533|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10534|NCT02500537|O1|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10535|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10536|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10798|NCT02495948|B1|Baseline|Overall|Lotrafilcon B and samfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
10540|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10541|NCT02500537|E2|Reported Event|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10542|NCT02500537|E1|Reported Event|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
10543|NCT02500368|B1|Baseline|Overall Baseline Characteristics|Participants were randomized to wear silicone hydrogel lens (test) or enfilcon A lens (control) for 1 week during the cross over study.
10544|NCT02500368|P2|Participant Flow|Enfilcon A Lens (Control), Then Silicone Hydrogel Lens (Test)|"Participants were randomized to wear enfilcon A lens (control) for 1 week, then cross over to the silicone hydrogel lens (test).
enfilcon A lens (control): contact lens
silicone hydrogel lens (test): contact lens"
10545|NCT02500368|P1|Participant Flow|Silicone Hydrogel Lens (Test), Then Enfilcon A Lens (Control)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week, then cross over to the enfilcon A lens (control).
silicone hydrogel lens (test): contact lens
enfilcon A lens (control): contact lens"
10546|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10547|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10548|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10549|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10550|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10551|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10552|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10553|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10554|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10555|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10556|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10557|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10558|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10559|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10560|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10561|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10562|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10563|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10564|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10565|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10566|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10568|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10569|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10570|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
11392|NCT02484898|P1|Participant Flow|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
10575|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10576|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10577|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10578|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10579|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10580|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10581|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10582|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10583|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10584|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10585|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10586|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10587|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10588|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10589|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10590|NCT02500368|E2|Reported Event|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
enfilcon A lens (control): contact lens"
10591|NCT02500368|E1|Reported Event|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
silicone hydrogel lens (test): contact lens"
10592|NCT02500056|B3|Baseline|Total|Total of all reporting groups
10593|NCT02500056|B2|Baseline|UM Group|"Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty"
10594|NCT02500056|B1|Baseline|OM Group|"Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty"
10595|NCT02500056|P2|Participant Flow|UM Group|"Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty"
10596|NCT02500056|P1|Participant Flow|OM Group|"Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty"
10597|NCT02500056|O2|Outcome|UM Group|"Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty"
10598|NCT02500056|O1|Outcome|OM Group|"Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty"
10599|NCT02500056|O2|Outcome|UM Group|"Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty"
10600|NCT02500056|O1|Outcome|OM Group|"Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty"
10601|NCT02500056|O2|Outcome|UM Group|"Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty"
10602|NCT02500056|O1|Outcome|OM Group|"Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty"
10603|NCT02500056|E2|Reported Event|UM Group|"Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty"
10604|NCT02500056|E1|Reported Event|OM Group|"Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty"
10605|NCT02499692|B1|Baseline|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
10606|NCT02499692|P1|Participant Flow|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
12026|NCT02478671|O1|Outcome|TR Band|Pulse Oxymetry
10607|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
10608|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
10609|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
10610|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
10611|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
10806|NCT02495831|B1|Baseline|Intervention|"Diclofenac sodium 50 mg oral tablets, single dose
Diclofenac sodium 50 mg oral tablets, single dose and safinamide 200 mg oral tablets, single dose"
10612|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
10613|NCT02499692|E1|Reported Event|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
10614|NCT02499575|B3|Baseline|Total|Total of all reporting groups
10615|NCT02499575|B2|Baseline|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
10616|NCT02499575|B1|Baseline|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
10617|NCT02499575|P2|Participant Flow|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
10618|NCT02499575|P1|Participant Flow|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
10619|NCT02499575|O2|Outcome|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
10620|NCT02499575|O1|Outcome|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
10621|NCT02499575|O2|Outcome|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
10622|NCT02499575|O1|Outcome|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
10623|NCT02499575|O2|Outcome|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
10624|NCT02499575|O1|Outcome|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
10625|NCT02499575|E2|Reported Event|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
10626|NCT02499575|E1|Reported Event|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
10627|NCT02498821|B3|Baseline|Total|Total of all reporting groups
11488|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
10628|NCT02498821|B2|Baseline|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10700|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10701|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10629|NCT02498821|B1|Baseline|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10630|NCT02498821|P2|Participant Flow|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® Tip Confirmation System (TCS) magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10631|NCT02498821|P1|Participant Flow|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10632|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10633|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10634|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10635|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10636|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10637|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10696|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10638|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10804|NCT02495948|E2|Reported Event|AIR OPTIX AQUA|All subjects exposed to lotrafilcon B contact lenses during Period 1 or Period 2
10639|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10640|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10641|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10642|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10643|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10644|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10645|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10646|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10647|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10697|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
12027|NCT02478671|O1|Outcome|TR Band|MRI based Radial artery measurement
10648|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10649|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10650|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10651|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10652|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10653|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10654|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10655|NCT02498821|E2|Reported Event|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10656|NCT02498821|E1|Reported Event|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
10657|NCT02498678|B3|Baseline|Total|Total of all reporting groups
10658|NCT02498678|B2|Baseline|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
Tetanus: tetanic electric stimulation"
10698|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
11489|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
10659|NCT02498678|B1|Baseline|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
10911|NCT02493036|P2|Participant Flow|Low Dose SYN-010|21-mg SYN-010
10660|NCT02498678|P2|Participant Flow|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
Tetanus: tetanic electric stimulation"
10661|NCT02498678|P1|Participant Flow|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
10662|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
Tetanus: tetanic electric stimulation"
10663|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
10664|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
Tetanus: tetanic electric stimulation"
10665|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
10666|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
Tetanus: tetanic electric stimulation"
10667|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
10668|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
Tetanus: tetanic electric stimulation"
10669|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
10670|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
Tetanus: tetanic electric stimulation"
10993|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10671|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
10672|NCT02498678|E2|Reported Event|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
Tetanus: tetanic electric stimulation"
10673|NCT02498678|E1|Reported Event|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
10674|NCT02498522|B3|Baseline|Total|Total of all reporting groups
10675|NCT02498522|B2|Baseline|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
Metformin: 83 patients will continue metformin until end of 1st trimester"
10676|NCT02498522|B1|Baseline|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)
Metformin: 83 patients will continue metformin until end of 1st trimester"
10677|NCT02498522|P2|Participant Flow|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
Metformin: 83 patients will continue metformin until end of 1st trimester"
10678|NCT02498522|P1|Participant Flow|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)
Metformin: 83 patients will continue metformin until end of 1st trimester"
10679|NCT02498522|O2|Outcome|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
Metformin: 83 patients will continue metformin until end of 1st trimester"
10680|NCT02498522|O1|Outcome|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)
Metformin: 83 patients will continue metformin until end of 1st trimester"
10681|NCT02498522|E2|Reported Event|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
Metformin: 83 patients will continue metformin until end of 1st trimester"
10682|NCT02498522|E1|Reported Event|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)
Metformin: 83 patients will continue metformin until end of 1st trimester"
10683|NCT02497235|B6|Baseline|Total|Total of all reporting groups
10684|NCT02497235|B5|Baseline|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
10685|NCT02497235|B4|Baseline|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10686|NCT02497235|B3|Baseline|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10687|NCT02497235|B2|Baseline|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10688|NCT02497235|B1|Baseline|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
10689|NCT02497235|P5|Participant Flow|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
10690|NCT02497235|P4|Participant Flow|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10691|NCT02497235|P3|Participant Flow|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10692|NCT02497235|P2|Participant Flow|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10693|NCT02497235|P1|Participant Flow|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
10694|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
10695|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
12028|NCT02478671|E1|Reported Event|TR Band|MRI based radial artery measurement
10699|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
10805|NCT02495948|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
10702|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10703|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
10704|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
10705|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10706|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10707|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10708|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
10709|NCT02497235|O1|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants.
10710|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
10711|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10712|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10713|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
10714|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
10715|NCT02497235|O1|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants.
10716|NCT02497235|E6|Reported Event|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
10717|NCT02497235|E5|Reported Event|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
10718|NCT02497235|E4|Reported Event|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
10719|NCT02497235|E3|Reported Event|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
10720|NCT02497235|E2|Reported Event|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
10721|NCT02497235|E1|Reported Event|Baseline [18F]MNI-792|[18F]MNI-792 up to 370 MBq (10mCi) with a mass of up to 5 mcg, injection, intravenously, prior to Positron Emission Tomography (PET) imaging at Baseline.
10722|NCT02496533|B3|Baseline|Total|Total of all reporting groups
10723|NCT02496533|B2|Baseline|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
10741|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
11534|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
10724|NCT02496533|B1|Baseline|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.
Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
10725|NCT02496533|P2|Participant Flow|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
10726|NCT02496533|P1|Participant Flow|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.
Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
10727|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
10728|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.
Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
10729|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
10730|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.
Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
10731|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
10732|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.
Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
10733|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
10734|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.
Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
10735|NCT02496533|E2|Reported Event|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
10736|NCT02496533|E1|Reported Event|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.
Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
10737|NCT02496221|B1|Baseline|Albiglutide 50 mg and Placebo|In a total of two treatment periods, participants received Albiglutide 50 mg (A) and Placebo (P) (in a sequence of either A-P or P-A), each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
10738|NCT02496221|P2|Participant Flow|Placebo Followed by Albiglutide 50 mg|Participants received Placebo in Treatment Period 1 and Albiglutide 50 mg in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
10739|NCT02496221|P1|Participant Flow|Albiglutide 50 mg Followed by Placebo|Participants received Albiglutide 50 milligrams (mg) in Treatment Period 1 and Placebo in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
10740|NCT02496221|O3|Outcome|Albiglutide 50 mg and Placebo|Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
11535|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
10742|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10743|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10744|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10745|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10746|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10747|NCT02496221|O1|Outcome|Albiglutide 50 mg and Placebo|In a total of two treatment periods, participants received Albiglutide 50 mg (A) and Placebo (P) (in a sequence of either A-P or P-A), each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of a cholecystokinin (sincalide) in each period.
10748|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10749|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10750|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10751|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10752|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10753|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10754|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10755|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10756|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10757|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10758|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10759|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10760|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10761|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10762|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10763|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10764|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10765|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10796|NCT02496000|E2|Reported Event|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo
ORMD-0801: Oral Insulin"
10766|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10767|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10768|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10769|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10770|NCT02496221|E2|Reported Event|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10771|NCT02496221|E1|Reported Event|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
10772|NCT02496039|B1|Baseline|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10773|NCT02496039|P1|Participant Flow|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10774|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10775|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10776|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10777|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10778|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10779|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10780|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10781|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10782|NCT02496039|O1|Outcome|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10783|NCT02496039|E1|Reported Event|20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate|Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180.
10784|NCT02496000|B4|Baseline|Total|Total of all reporting groups
10785|NCT02496000|B3|Baseline|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1
ORMD-0801: Oral Insulin"
10786|NCT02496000|B2|Baseline|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo
ORMD-0801: Oral Insulin"
10787|NCT02496000|B1|Baseline|Placebo Comparator|"three identical capsules containing placebo
Placebo Comparator: Placebo"
10788|NCT02496000|P3|Participant Flow|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1
ORMD-0801: Oral Insulin"
10789|NCT02496000|P2|Participant Flow|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo
ORMD-0801: Oral Insulin"
10790|NCT02496000|P1|Participant Flow|Placebo Comparator|"three identical capsules containing placebo
Placebo Comparator: Placebo"
10791|NCT02496000|O4|Outcome|ORMD-0801 Doses 1 and 2 Combined|The combined measurements of dose 1 and dose 2, in units of mg/dL
10792|NCT02496000|O3|Outcome|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1
ORMD-0801: Oral Insulin"
10793|NCT02496000|O2|Outcome|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo
ORMD-0801: Oral Insulin"
10794|NCT02496000|O1|Outcome|Placebo Comparator|"three identical capsules containing placebo
Placebo Comparator: Placebo"
10795|NCT02496000|E3|Reported Event|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1
ORMD-0801: Oral Insulin"
10797|NCT02496000|E1|Reported Event|Placebo Comparator|"three identical capsules containing placebo
Placebo Comparator: Placebo"
10799|NCT02495948|P2|Participant Flow|ULTRA Then AOA|Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
10800|NCT02495948|P1|Participant Flow|AOA Then ULTRA|Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
10801|NCT02495948|O2|Outcome|ULTRA|Samfilcon A contact lenses worn during Period 1 or Period 2 for 30 days
10802|NCT02495948|O1|Outcome|AIR OPTIX AQUA (AOA)|Lotrafilcon B contact lenses worn during Period 1 or Period 2 for 30 days
10803|NCT02495948|E3|Reported Event|ULTRA|All subjects exposed to samfilcon A contact lenses during Period 1 or Period 2
10807|NCT02495831|P2|Participant Flow|Safinamide + Diclofenac Sodium First, Diclofenac Sodium Second|Diclofenac sodium 50 mg oral tablets, single dose Safinamide 200 mg oral tablets, single dose
10808|NCT02495831|P1|Participant Flow|Diclofenac Sodium First, Safinamide + Diclofenac Sodium Second|Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
10809|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
10810|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose
Diclofenac sodium: Diclofenac sodium 50 mg single dose"
10811|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
10812|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose
Diclofenac sodium: Diclofenac sodium 50 mg single dose"
10813|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
10814|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose
Diclofenac sodium: Diclofenac sodium 50 mg single dose"
10815|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
10816|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose
Diclofenac sodium: Diclofenac sodium 50 mg single dose"
10817|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
10818|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose
Diclofenac sodium: Diclofenac sodium 50 mg single dose"
10819|NCT02495831|E2|Reported Event|Diclofenac Sodium and Safinamide|Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
10820|NCT02495831|E1|Reported Event|Diclofenac Sodium|Diclofenac sodium 50 mg oral tablets, single dose
10821|NCT02495623|B4|Baseline|Total|Total of all reporting groups
10822|NCT02495623|B3|Baseline|Placebo|Placebo
10823|NCT02495623|B2|Baseline|High Dose|42 mg SYN-010
10824|NCT02495623|B1|Baseline|Low Dose|21 mg SYN-010
10825|NCT02495623|P3|Participant Flow|Placebo|Placebo
10826|NCT02495623|P2|Participant Flow|High Dose|42 mg SYN-010
10827|NCT02495623|P1|Participant Flow|Low Dose|21 mg SYN-010
10828|NCT02495623|O3|Outcome|Placebo|"Placebo
Placebo"
10829|NCT02495623|O2|Outcome|High Dose|"42 mg SYN-010
SYN-010 42 mg"
10830|NCT02495623|O1|Outcome|Low Dose|"21 mg SYN-010
SYN-010 21 mg"
10831|NCT02495623|E3|Reported Event|Placebo|"Placebo
Placebo"
10832|NCT02495623|E2|Reported Event|High Dose|"42 mg SYN-010
SYN-010 42 mg"
10833|NCT02495623|E1|Reported Event|Low Dose|"21 mg SYN-010
SYN-010 21 mg"
10834|NCT02493855|B4|Baseline|Total|Total of all reporting groups
10835|NCT02493855|B3|Baseline|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
10836|NCT02493855|B2|Baseline|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
10837|NCT02493855|B1|Baseline|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
10838|NCT02493855|P3|Participant Flow|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
10839|NCT02493855|P2|Participant Flow|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
10840|NCT02493855|P1|Participant Flow|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
10841|NCT02493855|O3|Outcome|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
10842|NCT02493855|O2|Outcome|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
10843|NCT02493855|O1|Outcome|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
10844|NCT02493855|E3|Reported Event|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
10845|NCT02493855|E2|Reported Event|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
10846|NCT02493855|E1|Reported Event|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
10847|NCT02494596|B1|Baseline|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10848|NCT02494596|P3|Participant Flow|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10849|NCT02494596|P2|Participant Flow|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10850|NCT02494596|P1|Participant Flow|Capecitabine 825 Plus (+) Pertuzumab 1050|Participants received a single dose of capecitabine 825 milligrams per square meter (mg/m^2) orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10851|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10852|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10853|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10854|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10855|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10856|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10857|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10858|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10859|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10860|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10861|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10862|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10863|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10912|NCT02493036|P1|Participant Flow|High Dose SYN-010|42-mg SYN-010
10864|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10865|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10866|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10867|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10868|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10869|NCT02494596|O1|Outcome|Capecitabine 825 Plus (+) Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10870|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10871|NCT02494596|E3|Reported Event|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10872|NCT02494596|E2|Reported Event|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10873|NCT02494596|E1|Reported Event|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
10874|NCT02494440|B1|Baseline|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.
The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
10875|NCT02494440|P1|Participant Flow|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.
The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
10876|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.
The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
10877|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.
The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
10994|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10878|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.
The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
10879|NCT02494440|E1|Reported Event|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.
The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
10880|NCT02494323|B1|Baseline|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot
Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
10881|NCT02494323|P1|Participant Flow|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot
Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
10882|NCT02494323|O1|Outcome|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot
Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
10883|NCT02494323|O1|Outcome|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot
Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
10884|NCT02494323|E1|Reported Event|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot
Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
10885|NCT02493127|B3|Baseline|Total|Total of all reporting groups
10886|NCT02493127|B2|Baseline|Positive PCS|"Grip strength measurements and completes positively adjusted PCS
Grip Strength: Research Assistant takes Grip Strength Measurements
Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
10887|NCT02493127|B1|Baseline|Standard PCS|"Grip strength measurements and completes standard PCS
Standard PCS: Subject completes the standard version of the PCS Questionnaire
Grip Strength: Research Assistant takes Grip Strength Measurements"
10888|NCT02493127|P2|Participant Flow|Positive PCS|"Grip strength measurements and completes positively adjusted PCS
Grip Strength: Research Assistant takes Grip Strength Measurements
Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
10889|NCT02493127|P1|Participant Flow|Standard PCS|"Grip strength measurements and completes standard PCS
Standard PCS: Subject completes the standard version of the PCS Questionnaire
Grip Strength: Research Assistant takes Grip Strength Measurements"
10890|NCT02493127|O2|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS
Grip Strength: Research Assistant takes Grip Strength Measurements
Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
10891|NCT02493127|O1|Outcome|Standard PCS|"Grip strength measurements and completes standard PCS
Standard PCS: Subject completes the standard version of the PCS Questionnaire
Grip Strength: Research Assistant takes Grip Strength Measurements"
10892|NCT02493127|O2|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS
Grip Strength: Research Assistant takes Grip Strength Measurements
Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
10893|NCT02493127|O1|Outcome|Standard PCS|"Grip strength measurements and completes standard PCS
Standard PCS: Subject completes the standard version of the PCS Questionnaire
Grip Strength: Research Assistant takes Grip Strength Measurements"
10894|NCT02493127|O2|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS
Grip Strength: Research Assistant takes Grip Strength Measurements
Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
10895|NCT02493127|O1|Outcome|Standard PCS|"Grip strength measurements and completes standard PCS
Standard PCS: Subject completes the standard version of the PCS Questionnaire
Grip Strength: Research Assistant takes Grip Strength Measurements"
10896|NCT02493127|O1|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS
Grip Strength: Research Assistant takes Grip Strength Measurements
Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
10897|NCT02493127|O1|Outcome|Standard Pain Catastrophizing Scale (PCS)|"Grip strength measurements and completes standard PCS
Standard PCS: Subject completes the standard version of the PCS Questionnaire
Grip Strength: Research Assistant takes Grip Strength Measurements"
10898|NCT02493127|E2|Reported Event|Positive PCS|"Grip strength measurements and completes positively adjusted PCS
Grip Strength: Research Assistant takes Grip Strength Measurements
Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
10899|NCT02493127|E1|Reported Event|Standard PCS|"Grip strength measurements and completes standard PCS
Standard PCS: Subject completes the standard version of the PCS Questionnaire
Grip Strength: Research Assistant takes Grip Strength Measurements"
10900|NCT02493088|B1|Baseline|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder
Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
10901|NCT02493088|P1|Participant Flow|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder
Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
10902|NCT02493088|O1|Outcome|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder
Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
10903|NCT02493088|O1|Outcome|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder
Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
10904|NCT02493088|O1|Outcome|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder
Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
10905|NCT02493088|E1|Reported Event|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder
Aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder were recorded during the study.
Adverse events were not related to the study.
Recorded adverse events were situations where subjects were harmed and required medical intervention."
10906|NCT02493036|B4|Baseline|Total|Total of all reporting groups
10907|NCT02493036|B3|Baseline|Placebo/42-mg SYN-010|Placebo in study NCT02495623 followed by 42-mg SYN-010 in current study
10908|NCT02493036|B2|Baseline|21-mg SYN-010/42-mg SYN-010|21-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study
10909|NCT02493036|B1|Baseline|42-mg SYN-010/42-mg SYN-010|42-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study
10910|NCT02493036|P3|Participant Flow|Placebo|Placebo
10915|NCT02493036|O1|Outcome|42-mg SYN-010/42-mg SYN-010|Subjects were on 42 mg in the 4-week (double-blind) study and were continued on 42 mg in the 8-week extension study
10916|NCT02493036|E3|Reported Event|Placebo/42-mg SYN-010|Subjects were on placebo in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
10917|NCT02493036|E2|Reported Event|21-mg SYN-010/42-mg SYN-010|Subjects were on 21 mg in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
10918|NCT02493036|E1|Reported Event|42-mg SYN-010/42-mg SYN-010|Subjects were on 42 mg in the 4-week (double-blind) study and were continued on 42 mg in the 8-week extension study
10919|NCT02492984|B3|Baseline|Total|Total of all reporting groups
10920|NCT02492984|B2|Baseline|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
10921|NCT02492984|B1|Baseline|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
10922|NCT02492984|P2|Participant Flow|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
10923|NCT02492984|P1|Participant Flow|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
10924|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
10925|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
10926|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
10927|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
10928|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
10929|NCT02492984|O1|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
10930|NCT02492984|O1|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
10931|NCT02492984|O1|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
10932|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
10933|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
10934|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
10935|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
10936|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
10937|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
10938|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
10939|NCT02492984|E3|Reported Event|Total|Treatment Group Description TBD
10940|NCT02492984|E2|Reported Event|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
10941|NCT02492984|E1|Reported Event|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
10943|NCT02492841|B3|Baseline|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
10944|NCT02492841|B2|Baseline|Calcium Hydroxide|"-material for pulp capping
Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
10945|NCT02492841|B1|Baseline|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material
Mineral trioxide aggregate: Mineral trioxide aggregate"
10946|NCT02492841|P3|Participant Flow|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
10947|NCT02492841|P2|Participant Flow|Calcium Hydroxide|"-material for pulp capping
Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
10948|NCT02492841|P1|Participant Flow|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material
Mineral trioxide aggregate: Mineral trioxide aggregate"
10949|NCT02492841|O3|Outcome|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
10950|NCT02492841|O2|Outcome|Calcium Hydroxide|"-material for pulp capping
Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
10951|NCT02492841|O1|Outcome|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material
Mineral trioxide aggregate: Mineral trioxide aggregate"
10952|NCT02492841|O3|Outcome|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
Cero failed up to 12 months follow up"
10953|NCT02492841|O2|Outcome|Calcium Hydroxide|"-material for pulp capping
Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
Three failed up to 12 months follow up
two endodontic
one tooth extraction"
10954|NCT02492841|O1|Outcome|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material
Mineral trioxide aggregate: Mineral trioxide aggregate
Three failed up to 12 months follow up.
one endodontic
one pulpotomy
one pulp capping"
10955|NCT02492841|E3|Reported Event|Biodentine|"Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution."
10956|NCT02492841|E2|Reported Event|Calcium Hydroxide|"-material for pulp capping
Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material."
10957|NCT02492841|E1|Reported Event|Mineral Trioxide Aggregate (MTA)|"Mineral trioxide aggregate Root canal repair material
Mineral trioxide aggregate: Mineral trioxide aggregate"
10958|NCT02492451|B4|Baseline|Total|Total of all reporting groups
10959|NCT02492451|B3|Baseline|Control Group|Only intrauterine insemination
10960|NCT02492451|B2|Baseline|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
10961|NCT02492451|B1|Baseline|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle
Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
10962|NCT02492451|P3|Participant Flow|Control Group|Only intrauterine insemination
11483|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
10963|NCT02492451|P2|Participant Flow|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
10964|NCT02492451|P1|Participant Flow|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle
Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
10965|NCT02492451|O3|Outcome|Control Group|Only intrauterine insemination
10966|NCT02492451|O2|Outcome|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
10967|NCT02492451|O1|Outcome|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle
Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
10968|NCT02492451|E3|Reported Event|Control Group|Only intrauterine insemination
11393|NCT02484898|O1|Outcome|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
10969|NCT02492451|E2|Reported Event|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
10970|NCT02492451|E1|Reported Event|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle
Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
10971|NCT02492165|B5|Baseline|Total|Total of all reporting groups
10972|NCT02492165|B4|Baseline|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10973|NCT02492165|B3|Baseline|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10974|NCT02492165|B2|Baseline|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10975|NCT02492165|B1|Baseline|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10976|NCT02492165|P4|Participant Flow|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10977|NCT02492165|P3|Participant Flow|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10978|NCT02492165|P2|Participant Flow|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10979|NCT02492165|P1|Participant Flow|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10980|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10981|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10982|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10983|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10984|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10985|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10986|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10987|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10988|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10989|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10990|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10991|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10992|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
12029|NCT02478580|B3|Baseline|Total|Total of all reporting groups
10995|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10996|NCT02492165|E4|Reported Event|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10997|NCT02492165|E3|Reported Event|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10998|NCT02492165|E2|Reported Event|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
10999|NCT02492165|E1|Reported Event|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
11000|NCT02491944|B1|Baseline|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11001|NCT02491944|P1|Participant Flow|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11394|NCT02484898|E1|Reported Event|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
11002|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11003|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11004|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11005|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11006|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11007|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11008|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11009|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11010|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11011|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11012|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11013|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11014|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11015|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11016|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11017|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11018|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11019|NCT02491944|E1|Reported Event|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
11020|NCT02491892|B3|Baseline|Total|Total of all reporting groups
11021|NCT02491892|B2|Baseline|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11022|NCT02491892|B1|Baseline|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11023|NCT02491892|P2|Participant Flow|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11024|NCT02491892|P1|Participant Flow|Pertuzumab 420 mg|Participants received a loading dose of 840 milligrams (mg) via intravenous (IV) infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11025|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11026|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11027|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11028|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11029|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11395|NCT02484729|B11|Baseline|Total|Total of all reporting groups
11976|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
11030|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11031|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11032|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11033|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11034|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11035|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11036|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11037|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11038|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11039|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11040|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11041|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11042|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11043|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11044|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11045|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11046|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11047|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11048|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11049|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11050|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11051|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11052|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11053|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11054|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11055|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11056|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11057|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11058|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11059|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
21187|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
11060|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11061|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11062|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11063|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11064|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11065|NCT02491892|E2|Reported Event|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
11066|NCT02491892|E1|Reported Event|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
11067|NCT02490670|B3|Baseline|Total|Total of all reporting groups
11068|NCT02490670|B2|Baseline|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).
11069|NCT02490670|B1|Baseline|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
11070|NCT02490670|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).
11071|NCT02490670|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
11072|NCT02490670|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
11073|NCT02490670|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
11074|NCT02490670|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
11075|NCT02490670|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
11076|NCT02490670|E2|Reported Event|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
11077|NCT02490670|E1|Reported Event|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
11078|NCT02490475|B5|Baseline|Total|Total of all reporting groups
11079|NCT02490475|B4|Baseline|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11080|NCT02490475|B3|Baseline|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11081|NCT02490475|B2|Baseline|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11484|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11082|NCT02490475|B1|Baseline|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11083|NCT02490475|P4|Participant Flow|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11213|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.
Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
11214|NCT02488980|O1|Outcome|Placebo|"Placebo
Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
11084|NCT02490475|P3|Participant Flow|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11085|NCT02490475|P2|Participant Flow|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11086|NCT02490475|P1|Participant Flow|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 milligrams per square meter (mg/m^2) docetaxel and 1050 mg of pertuzumab as an intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 hours (h) apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11087|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11088|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11089|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11090|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11091|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11092|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11093|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11154|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11485|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11094|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11095|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11096|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11097|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11098|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11099|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11100|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11101|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11102|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11103|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11104|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11105|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11155|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
11486|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11106|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11107|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11108|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11109|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11110|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11111|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11112|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11113|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11114|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11115|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11116|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11117|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11156|NCT02490475|O1|Outcome|Entire Study Population|Participants received escalating dose levels of combination of docetaxel and pertuzumab. Participants received docetaxel 60 mg/m^2 and pertuzumab 1050 mg at dose level 1, docetaxel 75 mg/m^2 and pertuzumab 1050 mg at dose level 2, docetaxel 75 mg/m^2 and pertuzumab 420 mg at dose level 3 or 100 mg/m^2 and pertuzumab 420 mg at dose level 4 until DLTs were observed.
12030|NCT02478580|B2|Baseline|Control|Placebo in preoperative area
11118|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11119|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11120|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11121|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11122|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11123|NCT02490475|O4|Outcome|Docetaxel 75+ Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11124|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11125|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11126|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11127|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11128|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11129|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11130|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11131|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11215|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.
Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
11216|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.
Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
11132|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11133|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11134|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11135|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11136|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11137|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
11138|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11139|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11140|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
11141|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11142|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11143|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
11144|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11145|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11146|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
11147|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11148|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11149|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
11150|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11151|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11152|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
11153|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
11487|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11157|NCT02490475|E4|Reported Event|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11158|NCT02490475|E3|Reported Event|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11159|NCT02490475|E2|Reported Event|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11160|NCT02490475|E1|Reported Event|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
11161|NCT02490293|B3|Baseline|Total|Total of all reporting groups
11162|NCT02490293|B2|Baseline|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.
Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
11163|NCT02490293|B1|Baseline|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.
Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
11164|NCT02490293|P2|Participant Flow|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.
Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
11165|NCT02490293|P1|Participant Flow|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.
Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
11166|NCT02490293|O2|Outcome|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.
Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
11167|NCT02490293|O1|Outcome|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.
Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
11168|NCT02490293|O2|Outcome|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.
Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
11169|NCT02490293|O1|Outcome|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.
Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
11212|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.
Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
11170|NCT02490293|E2|Reported Event|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.
Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
11217|NCT02488980|O1|Outcome|Placebo|"Placebo
Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
11171|NCT02490293|E1|Reported Event|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.
Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
11172|NCT02489799|B3|Baseline|Total|Total of all reporting groups
11173|NCT02489799|B2|Baseline|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11174|NCT02489799|B1|Baseline|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11175|NCT02489799|P2|Participant Flow|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11176|NCT02489799|P1|Participant Flow|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11177|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11178|NCT02489799|O1|Outcome|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11179|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11180|NCT02489799|O1|Outcome|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11181|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11182|NCT02489799|O1|Outcome|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11183|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11184|NCT02489799|O1|Outcome|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11185|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11186|NCT02489799|O1|Outcome|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11187|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11218|NCT02488980|E3|Reported Event|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.
Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
11219|NCT02488980|E2|Reported Event|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.
Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
11188|NCT02489799|O1|Outcome|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11189|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11190|NCT02489799|O1|Outcome|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11191|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11192|NCT02489799|O1|Outcome|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11193|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11194|NCT02489799|O1|Outcome|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11195|NCT02489799|O2|Outcome|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11196|NCT02489799|O1|Outcome|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11197|NCT02489799|E2|Reported Event|Control|"Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care."
11198|NCT02489799|E1|Reported Event|Intervention|"Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon."
11199|NCT02488980|B4|Baseline|Total|Total of all reporting groups
11200|NCT02488980|B3|Baseline|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.
Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
11201|NCT02488980|B2|Baseline|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.
Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
11202|NCT02488980|B1|Baseline|Placebo|"Placebo
Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
11203|NCT02488980|P3|Participant Flow|Placebo|"Placebo
Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
11204|NCT02488980|P2|Participant Flow|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.
Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
11205|NCT02488980|P1|Participant Flow|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.
Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
11206|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.
Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
11207|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.
Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
11208|NCT02488980|O1|Outcome|Placebo|"Placebo
Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
11209|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.
Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
11210|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.
Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
11211|NCT02488980|O1|Outcome|Placebo|"Placebo
Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
11222|NCT02488317|B2|Baseline|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11223|NCT02488317|B1|Baseline|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11224|NCT02488317|P2|Participant Flow|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11225|NCT02488317|P1|Participant Flow|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11226|NCT02488317|O1|Outcome|Intervention Post-test|Intervention arm after reviewing the decision aid
11227|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11228|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11229|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11230|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11432|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11231|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11232|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11233|NCT02488317|O3|Outcome|Control|Control arm with no decision aid.
11234|NCT02488317|O2|Outcome|Intervention Post-test|Intervention arm responses after accessing the decision aid (N=63)
11235|NCT02488317|O1|Outcome|Intervention Pre-test|Intervention arm responses prior to accessing the decision aid (N=70)
11236|NCT02488317|E2|Reported Event|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11237|NCT02488317|E1|Reported Event|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
11238|NCT02488070|B1|Baseline|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
11239|NCT02488070|P1|Participant Flow|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
Computed Tomography: Undergo PET/CT
Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo PET/MRI
Positron Emission Tomography: Undergo PET/CT
Positron Emission Tomography: Undergo PET/MRI"
11240|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
11241|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
Computed Tomography: Part of PET/CT scan
Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope
Magnetic Resonance Imaging: Part of PET/MRI scan
Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans"
11242|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
Computed Tomography: Part of PET/CT scan
Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope
Magnetic Resonance Imaging: Part of PET/MRI scan
Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans"
11243|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
Computed Tomography: Part of PET/CT scan
Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope
Magnetic Resonance Imaging: Part of PET/MRI scan
Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans"
11244|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
11245|NCT02488070|E1|Reported Event|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
11246|NCT02488018|B1|Baseline|Provision of Experimental Honeys|Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule.
11247|NCT02488018|P1|Participant Flow|Honey Glycemic Index|"Study participants were given 25g available carbohydrate of reference glucose or monofloral honeys of Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense in 250 mL of water, after they have fasted for 11 hours overnight.
Monofloral honeys, namely: collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule."
11248|NCT02488018|O1|Outcome|Provision of Experimental Honeys|"Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food.
25g available carbohydrate of the test foods was provided to ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule."
11249|NCT02488018|E1|Reported Event|Honey Glycemic Index|Study participants were given 25g available carbohydrate of reference glucose or honey in 250 mL of water, after they have fasted for 11 hours overnight.
11250|NCT02486952|B1|Baseline|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
11397|NCT02484729|B9|Baseline|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11251|NCT02486952|P1|Participant Flow|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for diffuse large B cell lymphoma (DLBCL), and received rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
11252|NCT02486952|O1|Outcome|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
11253|NCT02486952|O1|Outcome|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
11254|NCT02486952|E1|Reported Event|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
11255|NCT02485483|B3|Baseline|Total|Total of all reporting groups
11256|NCT02485483|B2|Baseline|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
11257|NCT02485483|B1|Baseline|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11258|NCT02485483|P2|Participant Flow|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
11259|NCT02485483|P1|Participant Flow|VADERA I|Rheumatoid arthritis (RA) participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the World Health Organization Five Well-Being Index (WHO-5), Patient Health Questionnaire-9 (PHQ-9) and Beck Depression Inventory (2nd edition) (BDI-II) questionnaires and a subsequent structured interview using Montgomery-Åsberg Depression Rating Scale (MADRS) at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11260|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
11261|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
11262|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
11263|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11264|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11265|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11433|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11266|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11267|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11268|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11398|NCT02484729|B8|Baseline|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11269|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11270|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11271|NCT02485483|E2|Reported Event|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
11272|NCT02485483|E1|Reported Event|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
11273|NCT02485158|B1|Baseline|Healthy Adult Volunteers|All healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
11274|NCT02485158|P1|Participant Flow|Healthy Adult Volunteers|24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
11275|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11276|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11277|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11278|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11279|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11280|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11281|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11282|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11434|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11435|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11283|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11284|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11285|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11396|NCT02484729|B10|Baseline|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11286|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11287|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11288|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11289|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11290|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11291|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11292|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11293|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11294|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11295|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11296|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11297|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11298|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11299|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11300|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11301|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11302|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11303|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11436|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11304|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11305|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11306|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11307|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11308|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11309|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11310|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11311|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11312|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11313|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11314|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11315|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11316|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11317|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11318|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11319|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11320|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11321|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11322|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11323|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11324|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
12078|NCT02477605|E6|Reported Event|23-Gauge Systemic|Non-ocular adverse events
11325|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11326|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11327|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
21188|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
11328|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11329|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11330|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11331|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11332|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11333|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11334|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11335|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11336|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11337|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11338|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11339|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11340|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11341|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11342|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11343|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11344|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11345|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11437|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11346|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11347|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11348|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11349|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11350|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11351|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11352|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11353|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
11354|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
11355|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
11356|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
11357|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
11358|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
11359|NCT02485158|E1|Reported Event|Healthy Adult Volunteers|24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
11360|NCT02484911|B3|Baseline|Total|Total of all reporting groups
11361|NCT02484911|B2|Baseline|Control Regimen|"Aprepitant in combination with palonosetron and dexamethasone
Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1
Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
11362|NCT02484911|B1|Baseline|Olanzapine Regimen|"Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
Olanzapine: 5mg,twice a day orally on day 1 to day 4
Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1
Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
11363|NCT02484911|P2|Participant Flow|Control Regimen|"Aprepitant in combination with palonosetron and dexamethasone
Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1
Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
11364|NCT02484911|P1|Participant Flow|Olanzapine Regimen|"Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
Olanzapine: 5mg,twice a day orally on day 1 to day 4
Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1
Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
11365|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11438|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11366|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11367|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11368|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11977|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
11369|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11370|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11371|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11372|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11373|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11374|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11375|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11376|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11377|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11378|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11379|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11380|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11381|NCT02484911|O2|Outcome|Aprepitant Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11382|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11383|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11384|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11385|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11386|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11387|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11439|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11388|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11389|NCT02484911|E2|Reported Event|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV
Day2-Day3:
Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV
Day4:
Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
11390|NCT02484911|E1|Reported Event|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
11400|NCT02484729|B6|Baseline|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11401|NCT02484729|B5|Baseline|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11402|NCT02484729|B4|Baseline|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11403|NCT02484729|B3|Baseline|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11404|NCT02484729|B2|Baseline|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11405|NCT02484729|B1|Baseline|Part A- Placebo|Subjects received matching placebo under fasted conditions
11406|NCT02484729|P10|Participant Flow|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11407|NCT02484729|P9|Participant Flow|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11408|NCT02484729|P8|Participant Flow|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11409|NCT02484729|P7|Participant Flow|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11410|NCT02484729|P6|Participant Flow|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11411|NCT02484729|P5|Participant Flow|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11412|NCT02484729|P4|Participant Flow|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11413|NCT02484729|P3|Participant Flow|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11414|NCT02484729|P2|Participant Flow|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11415|NCT02484729|P1|Participant Flow|Part A- Placebo|Subjects received matching placebo under fasted conditions
11416|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11417|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11418|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11419|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11420|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11421|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11422|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11423|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11424|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11425|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11426|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11427|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11428|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11429|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11430|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11431|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
12079|NCT02477605|E5|Reported Event|23-Gauge Fellow Eye|Ocular events, untreated (fellow) eye
11440|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11441|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11442|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11443|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11444|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11445|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11446|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11447|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11448|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11449|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11450|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11451|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11452|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11453|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11454|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11455|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11456|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11457|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11458|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11459|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11460|NCT02484729|O10|Outcome|Oral Suspension (Part B)|
11461|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11462|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11463|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11464|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11465|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11466|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11467|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11468|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11469|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11470|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11471|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11472|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11473|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11474|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11475|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11476|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11477|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11478|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11479|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11480|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11481|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11482|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11490|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11491|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11492|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11493|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11494|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11495|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11496|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11497|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11498|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11499|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11500|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11501|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11502|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11503|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11504|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11505|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11506|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11507|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11508|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11509|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11510|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11511|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11512|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11513|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11514|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11515|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11516|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11517|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11518|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11519|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
11520|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11521|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11522|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11523|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11524|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11525|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11526|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11527|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11528|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11529|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
11530|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11531|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11532|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11533|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
20191|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
11536|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11537|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11538|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11539|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
11540|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11541|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11542|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11543|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11544|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11545|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11546|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11547|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11548|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11549|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
11550|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
21189|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
11551|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11552|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11553|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11554|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11555|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11556|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11557|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11558|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11559|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
11560|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11561|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11562|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11563|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11564|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11565|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11566|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11567|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11568|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11569|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
11570|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11571|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11572|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11573|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11574|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11575|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11576|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11577|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11578|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11579|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
11580|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11581|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11582|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11583|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11584|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11585|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11586|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11587|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11588|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11589|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
11590|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11591|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11592|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11593|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11594|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11595|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11596|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11597|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11978|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11598|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11599|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
11600|NCT02484729|E10|Reported Event|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
11601|NCT02484729|E9|Reported Event|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
11602|NCT02484729|E8|Reported Event|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
11603|NCT02484729|E7|Reported Event|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
11604|NCT02484729|E6|Reported Event|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
11605|NCT02484729|E5|Reported Event|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
11606|NCT02484729|E4|Reported Event|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
11607|NCT02484729|E3|Reported Event|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
11608|NCT02484729|E2|Reported Event|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
11609|NCT02484729|E1|Reported Event|Part A- Placebo|Subjects received matching placebo under fasted conditions
11610|NCT02483975|B3|Baseline|Total|Total of all reporting groups
11611|NCT02483975|B2|Baseline|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11612|NCT02483975|B1|Baseline|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11613|NCT02483975|P2|Participant Flow|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11614|NCT02483975|P1|Participant Flow|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 microgram (mcg) in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11615|NCT02483975|O2|Outcome|Placebo|Participants received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11616|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Participants received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11617|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11618|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11619|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
12080|NCT02477605|E4|Reported Event|23-Gauge Treated Eye|Ocular events, treated (study) eye
11620|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11621|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11622|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11623|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11624|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11625|NCT02483975|E2|Reported Event|Placebo|Participants received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11655|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11626|NCT02483975|E1|Reported Event|Fluticasone Furoate 50 mcg|Participants received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
11627|NCT02483611|B4|Baseline|Total|Total of all reporting groups
11628|NCT02483611|B3|Baseline|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11629|NCT02483611|B2|Baseline|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11630|NCT02483611|B1|Baseline|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11631|NCT02483611|P3|Participant Flow|Group C (Control Group - Isotonic Solution)|This group received isotonic solution in a equivalent volume as a bolus over 5 minutes, followed by continuous intravenous infusion of isotonic solution during the surgery.
11632|NCT02483611|P2|Participant Flow|Group ML (Magnesium Sulfate Plus Lidocaine)|This group received Magnesium Sulfate (MS) 40 mg/kg plus lidocaine 3 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h plus lidocaine 3 mg/kg/h during the surgery.
11633|NCT02483611|P1|Participant Flow|Group M (Magnesium Sulfate)|This group received Magnesium Sulfate (MS) 40 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h during the surgery.
11634|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11635|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11636|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11637|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11638|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11639|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11640|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11641|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11642|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11643|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11644|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11645|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11646|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11744|NCT02482428|O3|Outcome|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
12081|NCT02477605|E3|Reported Event|27-Gauge Systemic|Non-ocular adverse events
11647|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11648|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11649|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11650|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11651|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11652|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11653|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11654|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
29898|NCT02256891|O1|Outcome|Double Row|"Double Row
Double Row"
11656|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11657|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11658|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11659|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11660|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11661|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11662|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11663|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11664|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11665|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11666|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11667|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11668|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11669|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11670|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11671|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11672|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11673|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11674|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11675|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11676|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
20192|NCT02367066|E2|Reported Event|Placebo|Placebo, oral tablet
11677|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11678|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11679|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11680|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11681|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11682|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11683|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11684|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11685|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11686|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11687|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11688|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11689|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11690|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11691|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11692|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11693|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11694|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11695|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11696|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11697|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11698|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11699|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11700|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11701|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11702|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11703|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11704|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11705|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11706|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
20193|NCT02367066|E1|Reported Event|AZD1981|AZD1981, oral tablet
11707|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11708|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11709|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11710|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11711|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11712|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11713|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11714|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11715|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11716|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11717|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11718|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11719|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11720|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11721|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11722|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11723|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11724|NCT02483611|E3|Reported Event|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution"
11725|NCT02483611|E2|Reported Event|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine"
11726|NCT02483611|E1|Reported Event|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate"
11727|NCT02482428|B6|Baseline|Total|Total of all reporting groups
11728|NCT02482428|B5|Baseline|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
11729|NCT02482428|B4|Baseline|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11730|NCT02482428|B3|Baseline|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11731|NCT02482428|B2|Baseline|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11732|NCT02482428|B1|Baseline|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11733|NCT02482428|P5|Participant Flow|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
11734|NCT02482428|P4|Participant Flow|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11735|NCT02482428|P3|Participant Flow|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11736|NCT02482428|P2|Participant Flow|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11737|NCT02482428|P1|Participant Flow|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11738|NCT02482428|O4|Outcome|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
11739|NCT02482428|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
11740|NCT02482428|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11741|NCT02482428|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11742|NCT02482428|O5|Outcome|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
11743|NCT02482428|O4|Outcome|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
21111|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
11745|NCT02482428|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11746|NCT02482428|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11747|NCT02482428|O4|Outcome|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
11748|NCT02482428|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
11749|NCT02482428|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11750|NCT02482428|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11751|NCT02482428|E5|Reported Event|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
11752|NCT02482428|E4|Reported Event|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11753|NCT02482428|E3|Reported Event|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11754|NCT02482428|E2|Reported Event|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
11755|NCT02482428|E1|Reported Event|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
11756|NCT02482129|B3|Baseline|Total|Total of all reporting groups
11757|NCT02482129|B2|Baseline|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11758|NCT02482129|B1|Baseline|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11759|NCT02482129|P2|Participant Flow|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11760|NCT02482129|P1|Participant Flow|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11761|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11762|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11763|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11764|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11765|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11766|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11767|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11768|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11769|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11770|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11771|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11772|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11773|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11774|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11775|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11776|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11777|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11778|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11779|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11780|NCT02482129|O2|Outcome|Dexamethasone|Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
11781|NCT02482129|O1|Outcome|LME636|LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
11782|NCT02482129|E4|Reported Event|Posttreatment|All subjects from the conclusion of treatment until exit from the study
11783|NCT02482129|E3|Reported Event|Dexamethasone|All subjects exposed to Dexamethasone ophthalmic solution
11785|NCT02482129|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
11786|NCT02481934|B1|Baseline|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).
NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive: two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.
Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.
Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
11787|NCT02481934|P1|Participant Flow|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).
NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.
Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.
Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
11788|NCT02481934|O1|Outcome|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).
NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.
Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.
Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
11822|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
11979|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
29899|NCT02256891|O2|Outcome|Double Row With PRFM|PRFM
11789|NCT02481934|O1|Outcome|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).
NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.
Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.
Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
11790|NCT02481934|E1|Reported Event|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).
NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.
Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.
Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
11791|NCT02481219|B3|Baseline|Total|Total of all reporting groups
11792|NCT02481219|B2|Baseline|Bowel Preparation Regimen-Test|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin"
11793|NCT02481219|B1|Baseline|Bowel Preparation Regimen -Control|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl"
11794|NCT02481219|P2|Participant Flow|Bowel Preparation Regimen-Test|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin"
11795|NCT02481219|P1|Participant Flow|Bowel Preparation Regimen -Control|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl"
11796|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin"
11797|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Control
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl"
11798|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin"
11799|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Control
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl"
11800|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin"
11801|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure- Control
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl"
11802|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure- Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin"
11803|NCT02481219|O1|Outcome|Bowel Preparation Regimen - Control|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Control
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl"
11980|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
11981|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11804|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin"
11805|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Control
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl"
11806|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin"
11807|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl"
11808|NCT02481219|E2|Reported Event|Bowel Preparation Regimen-Test|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin"
11809|NCT02481219|E1|Reported Event|Bowel Preparation Regimen -Control|"Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Control
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl"
11810|NCT02480712|B1|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
11811|NCT02480712|P1|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
11812|NCT02480712|O3|Outcome|SOF/VEL 12 Weeks (Non TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
11813|NCT02480712|O2|Outcome|SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
11814|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.
11815|NCT02480712|O3|Outcome|SOF/VEL 12 Weeks (Non TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
11816|NCT02480712|O2|Outcome|SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
11872|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11817|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and ritonavir (RTV) or cobicistat (COBI)-boosted protease inhibitors (PIs) or other agents (eg, elvitegravir (EVG)/COBI)) are summarized in this group.
11818|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
11819|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
11820|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
11821|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
11823|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
11824|NCT02480712|E3|Reported Event|SOF/VEL 12 Weeks (Non TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
11825|NCT02480712|E2|Reported Event|SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
11826|NCT02480712|E1|Reported Event|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.
11827|NCT02480582|B1|Baseline|Overall Sample|Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack.
11828|NCT02480582|P6|Participant Flow|No Food, Then Almond, Then Cheese Savouries|Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received a mid-morning snack of cheese savouries.
11829|NCT02480582|P5|Participant Flow|Almond, Then Cheese Savouries, Then No Food|Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received no food.
11830|NCT02480582|P4|Participant Flow|Cheese Savouries, Then No Food, Then Almond|Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of almonds.
11831|NCT02480582|P3|Participant Flow|No Food, Then Cheese Savouries, Then Almond|Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received a mid-morning snack of almonds.
11832|NCT02480582|P2|Participant Flow|Cheese Savouries Then Almond, Then No Food|Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received no food.
11833|NCT02480582|P1|Participant Flow|Almond, Then No Food, Then Cheese Savouries|Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of cheese savouries.
11834|NCT02480582|O3|Outcome|No Food|No food provided, just water
11835|NCT02480582|O2|Outcome|Cheese Savouries|"Sainsbury's savoury biscuits
Cheese Savouries"
11836|NCT02480582|O1|Outcome|Almonds|"Whole, raw almonds
Almonds"
11837|NCT02480582|O3|Outcome|No Food|No food provided, just water
11838|NCT02480582|O2|Outcome|Cheese Savouries|"Sainsbury's savoury biscuits
Cheese Savouries"
11839|NCT02480582|O1|Outcome|Almonds|"Whole, raw almonds
Almonds"
11840|NCT02480582|O3|Outcome|No Food|No food provided, just water
11841|NCT02480582|O2|Outcome|Cheese Savouries|"Sainsbury's savoury biscuits
Cheese Savouries"
11842|NCT02480582|O1|Outcome|Almonds|"Whole, raw almonds
Almonds"
11843|NCT02480582|O3|Outcome|No Food|No food provided, just water
11844|NCT02480582|O2|Outcome|Cheese Savouries|Sainsbury's savoury biscuits Cheese Savouries
11845|NCT02480582|O1|Outcome|Almonds|Whole, raw almonds Almonds
11846|NCT02480582|E6|Reported Event|No Food, Then Almond, Then Cheese Savouries|"Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received a mid-morning snack of cheese savouries.
Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
11873|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
21112|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
11847|NCT02480582|E5|Reported Event|Almond, Then Cheese Savouries, Then No Food|"Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received no food.
Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
11848|NCT02480582|E4|Reported Event|Cheese Savouries, Then No Food, Then Almond|"Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of almonds.
Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
11849|NCT02480582|E3|Reported Event|No Food, Then Cheese Savouries, Then Almond|"Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received a mid-morning snack of almonds.
Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
11883|NCT02480010|P2|Participant Flow|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11850|NCT02480582|E2|Reported Event|Cheese Savouries Then Almond, Then No Food|"Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received no food.
Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
11851|NCT02480582|E1|Reported Event|Almond, Then No Food, Then Cheese Savouries|"Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of cheese savouries.
Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
11852|NCT02480439|B4|Baseline|Total|Total of all reporting groups
11853|NCT02480439|B3|Baseline|TAK-648 Sequence CAB|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
11854|NCT02480439|B2|Baseline|TAK-648 Sequence BCA|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
11855|NCT02480439|B1|Baseline|TAK-648 Sequence ABC|Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
11856|NCT02480439|P3|Participant Flow|TAK-648 Sequence CAB|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
11857|NCT02480439|P2|Participant Flow|TAK-648 Sequence BCA|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
11858|NCT02480439|P1|Participant Flow|TAK-648 Sequence ABC|Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
11859|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11860|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11861|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
11862|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11863|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11864|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
11865|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11866|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11867|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
11868|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11869|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11870|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
11871|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11874|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11875|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11876|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
11877|NCT02480439|E3|Reported Event|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11878|NCT02480439|E2|Reported Event|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
11879|NCT02480439|E1|Reported Event|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
11880|NCT02480010|B3|Baseline|Total|Total of all reporting groups
11881|NCT02480010|B2|Baseline|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11882|NCT02480010|B1|Baseline|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11884|NCT02480010|P1|Participant Flow|Pertuzumab 420 Milligrams (mg) - Cohort A|Participants in Cohort A received an intravenous (IV) loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11885|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11886|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11887|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11888|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11889|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11890|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11891|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11892|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11893|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11894|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11895|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11896|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11897|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11898|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11899|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11900|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11901|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11902|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11903|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11904|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11905|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11906|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11907|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11908|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11909|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11965|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
29900|NCT02256891|O1|Outcome|Double Row|Double Row
11910|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11911|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11912|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11913|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11914|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11915|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11916|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11917|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11918|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11919|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11920|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11921|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11922|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11923|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11924|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11925|NCT02480010|E2|Reported Event|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
11926|NCT02480010|E1|Reported Event|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
11927|NCT02479763|B3|Baseline|Total|Total of all reporting groups
11928|NCT02479763|B2|Baseline|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
11929|NCT02479763|B1|Baseline|Conventional Loss-of-resistance|Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
11930|NCT02479763|P2|Participant Flow|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
11931|NCT02479763|P1|Participant Flow|Conventional Loss-of-resistance|Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
11932|NCT02479763|O2|Outcome|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
11934|NCT02479763|E2|Reported Event|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
11935|NCT02479763|E1|Reported Event|Conventional Loss-of-resistance|
11936|NCT02479412|B10|Baseline|Total|Total of all reporting groups
11937|NCT02479412|B9|Baseline|Sequence 9 (AZD7594 800 μg + AZD7594 250 μg + Placebo)|Participant received AZD7594 800 μg in Treatment Period 1 (1st intervention 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11938|NCT02479412|B8|Baseline|Sequence 8 (AZD7594 800 μg + Placebo + AZD7594 250 μg)|Participants received AZD7594 800 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11939|NCT02479412|B7|Baseline|Sequence 7 (AZD7594 250 μg + AZD7594 58 μg + Placebo)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention- 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11966|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11940|NCT02479412|B6|Baseline|Sequence 6 (AZD7594 250 μg + Placebo + AZD7594 58 μg)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11941|NCT02479412|B5|Baseline|Sequence 5 (AZD7594 58 µg + AZD7594 800 µg + Placebo)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11942|NCT02479412|B4|Baseline|Sequence 4 (AZD7594 58 μg + Placebo + AZD7594 800 μg)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11943|NCT02479412|B3|Baseline|Sequence 3 (Placebo + AZD7594 800 µg + AZD7594 58 µg)|Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11944|NCT02479412|B2|Baseline|Sequence 2 (Placebo + AZD7594 250 μg + AZD7594 800 μg)|Participants received Placebo in Treatment Period 1 (1st intervention – 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention – 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention – 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11945|NCT02479412|B1|Baseline|Sequence 1 (Placebo + AZD7594 58 μg + AZD7594 250 μg)|Participants received Placebo in Treatment Period 1 (1st intervention – 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention – 14 days) and AZD7594 250 μg treatment in Period 3 (3rd intervention – 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11946|NCT02479412|P9|Participant Flow|Sequence 9 (AZD7594 800 μg + AZD7594 250 μg + Placebo)|Participant received AZD7594 800 μg in Treatment Period 1 (1st intervention 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11947|NCT02479412|P8|Participant Flow|Sequence 8 (AZD7594 800 μg + Placebo + AZD7594 250 μg)|Participants received AZD7594 800 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11948|NCT02479412|P7|Participant Flow|Sequence 7 (AZD7594 250 μg + AZD7594 58 μg + Placebo)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention- 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11949|NCT02479412|P6|Participant Flow|Sequence 6 (AZD7594 250 μg + Placebo + AZD7594 58 μg)|Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11950|NCT02479412|P5|Participant Flow|Sequence 5 (AZD7594 58 µg + AZD7594 800 µg + Placebo)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11951|NCT02479412|P4|Participant Flow|Sequence 4 (AZD7594 58 μg + Placebo + AZD7594 800 μg)|Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11952|NCT02479412|P3|Participant Flow|Sequence 3 (Placebo + AZD7594 800 µg + AZD7594 58 µg)|Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11953|NCT02479412|P2|Participant Flow|Sequence 2 (Placebo + AZD7594 250 μg + AZD7594 800 μg)|Participants received Placebo in Treatment Period 1 (1st intervention – 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention – 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention – 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
12031|NCT02478580|B1|Baseline|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area
NUVIGIL: Patient will receive Nuvigil before the surgery"
12032|NCT02478580|P2|Participant Flow|Control|Placebo in preoperative area
11954|NCT02479412|P1|Participant Flow|Sequence 1 (Placebo + AZD7594 58 μg + AZD7594 250 μg)|Participants received Placebo in Treatment Period 1 (1st intervention – 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention – 14 days) and AZD7594 250 μg treatment in Period 3 (3rd intervention – 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.
11955|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
11956|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
11957|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11958|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
11959|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
11960|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11961|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
11962|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
11963|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11964|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
32751|NCT02227485|B3|Baseline|Total|Total of all reporting groups
11982|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
11983|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
11984|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11985|NCT02479412|O3|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
11986|NCT02479412|O2|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
11987|NCT02479412|O1|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11988|NCT02479412|O4|Outcome|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
11989|NCT02479412|O3|Outcome|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
11990|NCT02479412|O2|Outcome|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
11991|NCT02479412|O1|Outcome|Placebo|Placebo for AZD7594 DPI once daily
11992|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
11993|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
11994|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
11995|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
11996|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
11997|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
11998|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
11999|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
12000|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
12001|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
12002|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
12003|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
12004|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
12005|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
12006|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
12007|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
12008|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
12009|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
12010|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
12011|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
12012|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
12013|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
12014|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
12015|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
12016|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
12017|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
12018|NCT02479412|O2|Outcome|Placebo|Placebo for AZD7594 DPI once daily
12019|NCT02479412|O1|Outcome|AZD7594|AZD7594 DPI once daily
12020|NCT02479412|E4|Reported Event|AZD7594 800 μg|AZD7594 DPI once daily - 2 capsules of 400 μg
12021|NCT02479412|E3|Reported Event|AZD7594 250 μg|AZD7594 DPI once daily - 2 capsules of 125 μg
12022|NCT02479412|E2|Reported Event|AZD7594 58 μg|AZD7594 DPI once daily - 2 capsules of 29 μg
12023|NCT02479412|E1|Reported Event|Placebo (PBO)|Placebo for AZD7594 DPI once daily
12033|NCT02478580|P1|Participant Flow|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area
NUVIGIL: Patient will receive Nuvigil before the surgery"
12034|NCT02478580|O2|Outcome|Control|Placebo in preoperative area
12035|NCT02478580|O1|Outcome|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area
NUVIGIL: Patient will receive Nuvigil before the surgery"
12036|NCT02478580|E2|Reported Event|Control|Placebo in preoperative area
12037|NCT02478580|E1|Reported Event|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area
NUVIGIL: Patient will receive Nuvigil before the surgery"
12038|NCT02478372|B3|Baseline|Total|Total of all reporting groups
12039|NCT02478372|B2|Baseline|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12040|NCT02478372|B1|Baseline|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
12041|NCT02478372|P2|Participant Flow|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12262|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
12042|NCT02478372|P1|Participant Flow|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
12043|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12044|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
12045|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12046|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
12075|NCT02477605|O1|Outcome|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
12076|NCT02477605|O2|Outcome|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
12047|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12048|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
12049|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12050|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
13021|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
12051|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12052|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
12053|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12054|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
12055|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12077|NCT02477605|O1|Outcome|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
12056|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
12057|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12058|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
12059|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12060|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
12061|NCT02478372|E2|Reported Event|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
12062|NCT02478372|E1|Reported Event|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
12063|NCT02477709|B1|Baseline|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
12064|NCT02477709|P1|Participant Flow|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
12065|NCT02477709|O1|Outcome|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
12066|NCT02477709|E1|Reported Event|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
12067|NCT02477605|B3|Baseline|Total|Total of all reporting groups
12068|NCT02477605|B2|Baseline|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
12069|NCT02477605|B1|Baseline|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
12070|NCT02477605|P2|Participant Flow|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
12071|NCT02477605|P1|Participant Flow|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
12072|NCT02477605|O2|Outcome|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
12073|NCT02477605|O1|Outcome|27-Gauge|CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
12074|NCT02477605|O2|Outcome|23-Gauge|CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
12082|NCT02477605|E2|Reported Event|27-Gauge Fellow Eye|Ocular events, untreated (fellow) eye
12083|NCT02477605|E1|Reported Event|27-Gauge Treated Eye|Ocular events, treated (study) eye
12084|NCT02477527|B1|Baseline|Stribild|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
12085|NCT02477527|P1|Participant Flow|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
12086|NCT02477527|O1|Outcome|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
12087|NCT02477527|O1|Outcome|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
12088|NCT02477527|O1|Outcome|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
12089|NCT02477527|O1|Outcome|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
12090|NCT02477527|O1|Outcome|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
12263|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
12091|NCT02477527|E1|Reported Event|Study|"Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day."
12092|NCT02476422|B3|Baseline|Total|Total of all reporting groups
12093|NCT02476422|B2|Baseline|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12094|NCT02476422|B1|Baseline|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12095|NCT02476422|P2|Participant Flow|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12096|NCT02476422|P1|Participant Flow|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12097|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12098|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12099|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12100|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12101|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12102|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12143|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)
Placebo: 40mg of starch"
12103|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12104|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12105|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12106|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12107|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12108|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12109|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12110|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
35479|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
12111|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12112|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12113|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12114|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12115|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12116|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12117|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12118|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12119|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12120|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12121|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12122|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12123|NCT02476422|E2|Reported Event|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
12124|NCT02476422|E1|Reported Event|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
12125|NCT02475980|B1|Baseline|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling
Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
12126|NCT02475980|P1|Participant Flow|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling
Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
12127|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling
Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
12128|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling
Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
12264|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
12129|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling
Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
12130|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling
Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
12131|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling
Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
12132|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling
Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
12133|NCT02475980|E1|Reported Event|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling
Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
12134|NCT02475564|B3|Baseline|Total|Total of all reporting groups
12135|NCT02475564|B2|Baseline|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)
Placebo: 40mg of starch"
12136|NCT02475564|B1|Baseline|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)"
12137|NCT02475564|P2|Participant Flow|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)"
12138|NCT02475564|P1|Participant Flow|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)
Placebo: 40mg of starch"
12139|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)
Placebo: 40mg of starch"
12140|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)"
12141|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)
Placebo: 40mg of starch"
12142|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)"
21113|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
12144|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)"
12145|NCT02475564|E2|Reported Event|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)"
12146|NCT02475564|E1|Reported Event|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)
Placebo: 40mg of starch"
12147|NCT02475395|B3|Baseline|Total|Total of all reporting groups
12148|NCT02475395|B2|Baseline|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12149|NCT02475395|B1|Baseline|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12150|NCT02475395|P2|Participant Flow|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12151|NCT02475395|P1|Participant Flow|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12152|NCT02475395|O2|Outcome|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12153|NCT02475395|O1|Outcome|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12154|NCT02475395|O2|Outcome|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12155|NCT02475395|O1|Outcome|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12265|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
12156|NCT02475395|O2|Outcome|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12157|NCT02475395|O1|Outcome|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12158|NCT02475395|E2|Reported Event|Tester Only Subjects|"Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12159|NCT02475395|E1|Reported Event|Donor/Tester Subjects|"Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen
TRAK device: Use of TRAK to attain sperm concentration measurement"
12160|NCT02475278|B1|Baseline|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
12161|NCT02475278|P1|Participant Flow|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
12162|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
12163|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
12164|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
12165|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
12166|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
12167|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
12168|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
12169|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
12170|NCT02475278|E1|Reported Event|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
12171|NCT02475031|B3|Baseline|Total|Total of all reporting groups
12172|NCT02475031|B2|Baseline|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12173|NCT02475031|B1|Baseline|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12174|NCT02475031|P2|Participant Flow|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12175|NCT02475031|P1|Participant Flow|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12176|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12266|NCT02473367|E4|Reported Event|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
12177|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12178|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12179|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12180|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12181|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12182|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP-C: TAP catheters with ropivacaine infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case."
12183|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP-S: Catheters with saline infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case."
12184|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12226|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12185|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12186|NCT02475031|E2|Reported Event|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12187|NCT02475031|E1|Reported Event|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen"
12188|NCT02474498|B4|Baseline|Total|Total of all reporting groups
12229|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12189|NCT02474498|B3|Baseline|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.
EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12190|NCT02474498|B2|Baseline|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).
12191|NCT02474498|B1|Baseline|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12192|NCT02474498|P3|Participant Flow|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA).
12193|NCT02474498|P2|Participant Flow|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12194|NCT02474498|P1|Participant Flow|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.
EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12195|NCT02474498|O3|Outcome|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA).
12251|NCT02473510|E1|Reported Event|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
12196|NCT02474498|O2|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12197|NCT02474498|O1|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.
EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12267|NCT02473367|E3|Reported Event|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
12268|NCT02473367|E2|Reported Event|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
12198|NCT02474498|O3|Outcome|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA).
12199|NCT02474498|O2|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12200|NCT02474498|O1|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.
EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12201|NCT02474498|O3|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.
EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12202|NCT02474498|O2|Outcome|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).
12203|NCT02474498|O1|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12204|NCT02474498|O3|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.
EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12252|NCT02473367|B1|Baseline|All Enrolled Participants|All participants who enrolled in the study
12455|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
12205|NCT02474498|O2|Outcome|βTCP/HA + EMD|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12206|NCT02474498|O1|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12207|NCT02474498|E3|Reported Event|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.
EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12208|NCT02474498|E2|Reported Event|βTCP/HA + EMD|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12209|NCT02474498|E1|Reported Event|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
12210|NCT02473991|B1|Baseline|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).
All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).
At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.
After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
12211|NCT02473991|P1|Participant Flow|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).
All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).
At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.
After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
12212|NCT02473991|O1|Outcome|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).
All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).
At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.
After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
12285|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
12213|NCT02473991|O1|Outcome|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).
All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).
At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.
After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
12230|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12269|NCT02473367|E1|Reported Event|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
12270|NCT02472886|B4|Baseline|Total|Total of all reporting groups
35480|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
12214|NCT02473991|O1|Outcome|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).
All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).
At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.
After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
12215|NCT02473991|E1|Reported Event|Pregnant Women|"All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI).
All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15–20 weeks of gestation) as well as third trimester (30–34 weeks of gestation).
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985).
At the time of delivery , the birth weight (in grams), and mode of delivery was be taken.
After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010)."
12216|NCT02473523|B1|Baseline|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12217|NCT02473523|P1|Participant Flow|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12218|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12219|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12220|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12221|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12222|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12223|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12224|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12225|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12227|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12228|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12261|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
12231|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12232|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12233|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12234|NCT02473523|E1|Reported Event|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.
Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
12235|NCT02473510|B3|Baseline|Total|Total of all reporting groups
12236|NCT02473510|B2|Baseline|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
12237|NCT02473510|B1|Baseline|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
12238|NCT02473510|P2|Participant Flow|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
12239|NCT02473510|P1|Participant Flow|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
12240|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
12241|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
12242|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
12243|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
12244|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
12245|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
12246|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
12247|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
12248|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
12249|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
12250|NCT02473510|E2|Reported Event|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
12253|NCT02473367|P1|Participant Flow|Four Period Fixed Sequence|All participants entered the first of four treatment periods. Period 1: 1200 mg raltegravir alone; followed by Period 2: 1200 mg raltegravir and TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3: 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4: 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. There was a maximum 7-day wait between each period where participants were treated once daily with 1200 mg raltegravir.
12254|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
12255|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
12256|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
12257|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
12258|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
12259|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
12260|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
12271|NCT02472886|B3|Baseline|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
12272|NCT02472886|B2|Baseline|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
12273|NCT02472886|B1|Baseline|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF(90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
12274|NCT02472886|P3|Participant Flow|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir (SOF) study
12275|NCT02472886|P2|Participant Flow|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
12276|NCT02472886|P1|Participant Flow|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|Ledipasvir/sofosbuvir (LDV/SOF; Harvoni®) (90/400 mg) fixed dose combination (FDC) tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
12277|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV Experienced)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants were on a stable ARV regimen for at least 8 weeks prior to screening.
12278|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV- Naive)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants did not receive any prior ARV therapy.
12279|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
12280|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
12281|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
12282|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosiss
12283|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
12284|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
12286|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
12287|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
12288|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
12289|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
12290|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
12291|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
12292|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
12293|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
12294|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
12295|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
12296|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
12297|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
12424|NCT02470429|P2|Participant Flow|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12298|NCT02472886|E3|Reported Event|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
12299|NCT02472886|E2|Reported Event|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
12300|NCT02472886|E1|Reported Event|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
12301|NCT02472847|B3|Baseline|Total|Total of all reporting groups
12302|NCT02472847|B2|Baseline|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning
Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
12303|NCT02472847|B1|Baseline|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.
Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
12304|NCT02472847|P2|Participant Flow|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning
Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
12305|NCT02472847|P1|Participant Flow|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.
Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
12306|NCT02472847|O2|Outcome|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning
Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
12456|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
21114|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
12307|NCT02472847|O1|Outcome|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.
Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
12308|NCT02472847|E2|Reported Event|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning
Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
12309|NCT02472847|E1|Reported Event|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.
Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
12310|NCT02472756|B1|Baseline|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
12311|NCT02472756|P1|Participant Flow|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician’s discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
12396|NCT02471612|O1|Outcome|Surviving Patients|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed ventilatory support postoperatively
12312|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
12313|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
12314|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
12315|NCT02472756|E1|Reported Event|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
12316|NCT02472522|B3|Baseline|Total|Total of all reporting groups
12317|NCT02472522|B2|Baseline|Ropivacaine + Dexmedetomidine|"Patients satisfying the inclusion criteria received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12318|NCT02472522|B1|Baseline|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12319|NCT02472522|P2|Participant Flow|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12386|NCT02471612|P1|Participant Flow|All Patients Who Underwent Emergency Exploratory Laparotomy|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the P-POSSUM Score APACHE-II
12320|NCT02472522|P1|Participant Flow|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12321|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12322|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12323|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12397|NCT02471612|O1|Outcome|Length of Stay|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were observed for their length of stay (LOS)
12324|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12325|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12326|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12327|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12328|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12329|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12330|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12999|NCT02461693|E2|Reported Event|Placebo|"One-time treatment with lactose-based placebo pill
Placebo"
12331|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12332|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12333|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12334|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12335|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12336|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12337|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying the inclusion criteria received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12338|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12339|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12340|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12341|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12457|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
21115|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
12342|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12343|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12344|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12345|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12346|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12347|NCT02472522|E2|Reported Event|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
12348|NCT02472522|E1|Reported Event|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
12349|NCT02472366|B3|Baseline|Total|Total of all reporting groups
12350|NCT02472366|B2|Baseline|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12351|NCT02472366|B1|Baseline|Laser|"laser with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12352|NCT02472366|P2|Participant Flow|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12353|NCT02472366|P1|Participant Flow|Laser|"laser with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12354|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12355|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12356|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12357|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12358|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12359|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12360|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12361|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12362|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12363|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12364|NCT02472366|E2|Reported Event|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12365|NCT02472366|E1|Reported Event|Laser|"laser with or without prior history of intraocular corticosteroid therapy
ILUVIEN"
12366|NCT02471755|B3|Baseline|Total|Total of all reporting groups
12458|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
12367|NCT02471755|B2|Baseline|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
12368|NCT02471755|B1|Baseline|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
12369|NCT02471755|P2|Participant Flow|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
12392|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)
12370|NCT02471755|P1|Participant Flow|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
12371|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
12372|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
12373|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
12374|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
12375|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
12387|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed re-exploration during the post-operative period.
21116|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
12376|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
12377|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
12393|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the need for inotropic support during their stay..
12394|NCT02471612|O1|Outcome|Surviving Patients|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the need for inotropic support during their stay..
35481|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
12378|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
12379|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
12380|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
12381|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
12382|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
12383|NCT02471755|E2|Reported Event|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
12384|NCT02471755|E1|Reported Event|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
12385|NCT02471612|B1|Baseline|Emergency Laparotomy|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the APACHE-2 Score & P-POSSUM Score
12388|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed re-exploration during the post-operative period.
12389|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the Acute Kidney Injury
12390|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the Acute Kidney Injury
12391|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)
12395|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed ventilatory support postoperatively
12398|NCT02471612|O2|Outcome|AUC Using P-POSSUM|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery.
12399|NCT02471612|O1|Outcome|AUC Using APACHE II|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.
12400|NCT02471612|E2|Reported Event|P-POSSUM|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery
12401|NCT02471612|E1|Reported Event|APACHE-2 Scoring|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.
12402|NCT02470949|B1|Baseline|All Study Participants|High Social Status Condition in Monopoly Game and Low Social Status Condition in Monopoly Game
12403|NCT02470949|P2|Participant Flow|High Social Status, Then Low Social Status|High Social Status Condition in Monopoly Game during the first intervention period and Low Social Status Condition in Monopoly Game during the second intervention period (after washout period).
12404|NCT02470949|P1|Participant Flow|Low Social Status, Then High Social Status|Low Social Status Condition in Monopoly Game during the first intervention period and High Social Status Condition in Monopoly Game during the second intervention period (after washout period).
12405|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game
High Social Status: The participants will be randomized to the High Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
12406|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.
Low Social Status: The participants will be randomized to the Low Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
12407|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game
High Social Status: The participants will be randomized to the High Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
12408|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.
Low Social Status: The participants will be randomized to the Low Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
12409|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game
Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
12410|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.
Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
12411|NCT02470949|E2|Reported Event|High Social Status|"High Social Status Condition in Monopoly Game
Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
12454|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
12412|NCT02470949|E1|Reported Event|Low Social Status|"Low Social Status Condition in Monopoly Game.
Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
12413|NCT02470494|B1|Baseline|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
12414|NCT02470494|P1|Participant Flow|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
12415|NCT02470494|O1|Outcome|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
12416|NCT02470494|O1|Outcome|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
12417|NCT02470494|O1|Outcome|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
12418|NCT02470494|O1|Outcome|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
12419|NCT02470494|O1|Outcome|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
12420|NCT02470494|E1|Reported Event|Sound Amplification Via EarLens CHD|"Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD."
12421|NCT02470429|B3|Baseline|Total|Total of all reporting groups
12422|NCT02470429|B2|Baseline|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12423|NCT02470429|B1|Baseline|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12425|NCT02470429|P1|Participant Flow|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12426|NCT02470429|O2|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12427|NCT02470429|O1|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12428|NCT02470429|O2|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12429|NCT02470429|O1|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12430|NCT02470429|O2|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12431|NCT02470429|O1|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12432|NCT02470429|O2|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12433|NCT02470429|O1|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
12434|NCT02470429|E3|Reported Event|Hyabak 0.15%|All subjects treated with Hyabak 0.15% eye drops
12435|NCT02470429|E2|Reported Event|SYSTANE HYDRATION|All subjects treated with SYSTANE HYDRATION lubricant eye drops
12436|NCT02470429|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
12437|NCT02470403|B6|Baseline|Total|Total of all reporting groups
12438|NCT02470403|B5|Baseline|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
12439|NCT02470403|B4|Baseline|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
12440|NCT02470403|B3|Baseline|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
12441|NCT02470403|B2|Baseline|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
12442|NCT02470403|B1|Baseline|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12443|NCT02470403|P5|Participant Flow|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
12444|NCT02470403|P4|Participant Flow|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
12445|NCT02470403|P3|Participant Flow|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
12446|NCT02470403|P2|Participant Flow|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
12447|NCT02470403|P1|Participant Flow|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12448|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
12449|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
12450|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
12451|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
12452|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
12453|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
12459|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
12460|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12461|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12462|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12463|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12464|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12465|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12466|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
12467|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
12468|NCT02470403|O3|Outcome|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
12469|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
12470|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
12471|NCT02470403|O4|Outcome|Part 1 and 2 : Pooled Placebo|Placebo subjects were pooled between the 2 parts and were considered a single treatment arm for the analyses
12472|NCT02470403|O3|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
12473|NCT02470403|O2|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
12474|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12475|NCT02470403|O2|Outcome|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
12476|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12477|NCT02470403|O2|Outcome|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
12478|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12479|NCT02470403|E5|Reported Event|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
12480|NCT02470403|E4|Reported Event|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
12481|NCT02470403|E3|Reported Event|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
12482|NCT02470403|E2|Reported Event|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
35482|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
12483|NCT02470403|E1|Reported Event|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
12484|NCT02469961|B3|Baseline|Total|Total of all reporting groups
12485|NCT02469961|B2|Baseline|Propofol|"Participants will receive an interscalene block and be sedated with propofol
Propofol: Participants will receive an interscalene block and be sedated with propofol and compared to sedation with Dexmedetomidine
Interscalene block: Interscalene block is used for the main anesthetic for the case"
12486|NCT02469961|B1|Baseline|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine
Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol
Interscalene block: Interscalene block is used for the main anesthetic for the case"
12487|NCT02469961|P2|Participant Flow|Propofol|"Participants will receive an interscalene block and be sedated with propofol
Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme
Interscalene block: Interscalene block is used for the main anesthetic for the case"
12488|NCT02469961|P1|Participant Flow|Dexmedetomidne|"Participants will receive an interscalene block and be sedated with dexmedetomidine
Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol
Interscalene block: Interscalene block is used for the main anesthetic for the case"
12489|NCT02469961|O2|Outcome|Propofol|"Participants will receive an interscalene block and be sedated with propofol
Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine
Interscalene block: Interscalene block is used for the main anesthetic for the case"
12490|NCT02469961|O1|Outcome|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine
Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol
Interscalene block: Interscalene block is used for the main anesthetic for the case"
12491|NCT02469961|O2|Outcome|Dexmedetomidine|Patients who received Dexmedetomidine
12492|NCT02469961|O1|Outcome|Propofol|Patients who received Propofol
12493|NCT02469961|O2|Outcome|Propofol|"Participants will receive an interscalene block and be sedated with propofol
Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme
Interscalene block: Interscalene block is used for the main anesthetic for the case"
12494|NCT02469961|O1|Outcome|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine
Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol
Interscalene block: Interscalene block is used for the main anesthetic for the case"
12495|NCT02469961|O2|Outcome|Propofol|Number of patients required airway manipulations
12496|NCT02469961|O1|Outcome|Dexmedetomidine|Number of patients required airway manipulation
12497|NCT02469961|E2|Reported Event|Propofol|"Participants will receive an interscalene block and be sedated with propofol
Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme
Interscalene block: Interscalene block is used for the main anesthetic for the case"
12532|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
13170|NCT02454959|P1|Participant Flow|Overall Study|All Randomized Patients
12498|NCT02469961|E1|Reported Event|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine
Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol
Interscalene block: Interscalene block is used for the main anesthetic for the case"
12499|NCT02469597|B3|Baseline|Total|Total of all reporting groups
12500|NCT02469597|B2|Baseline|Placebo|"Normal saline 1 dose
Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
12501|NCT02469597|B1|Baseline|Single Dose of Furosemide|"Furosemide 1 dose
Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
12502|NCT02469597|P2|Participant Flow|Placebo|"Normal saline 1 dose
Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
12503|NCT02469597|P1|Participant Flow|Single Dose of Furosemide|"Furosemide 1 dose
Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
12504|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose
Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
12505|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose
Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
12506|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose
Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
12507|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose
Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
12508|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose
Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
12509|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose
Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
12510|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose
Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
12511|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose
Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
12512|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose
Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
12513|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose
Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
12514|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose
Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
12515|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose
Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
12516|NCT02469597|E2|Reported Event|Placebo|"Normal saline 1 dose
Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
12517|NCT02469597|E1|Reported Event|Single Dose of Furosemide|"Furosemide 1 dose
Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
12518|NCT02469298|B5|Baseline|Total|Total of all reporting groups
12519|NCT02469298|B4|Baseline|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12520|NCT02469298|B3|Baseline|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12521|NCT02469298|B2|Baseline|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12522|NCT02469298|B1|Baseline|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12523|NCT02469298|P4|Participant Flow|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12524|NCT02469298|P3|Participant Flow|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12525|NCT02469298|P2|Participant Flow|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12526|NCT02469298|P1|Participant Flow|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12527|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
12528|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
12529|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
12530|NCT02469298|O1|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
12531|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
21117|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
12533|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
12534|NCT02469298|O1|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
12535|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
12536|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
12537|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
12538|NCT02469298|O1|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
12539|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12540|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12541|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12542|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12543|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12544|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12545|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12546|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12547|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
13022|NCT02460458|E1|Reported Event|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
12548|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12549|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12550|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12551|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12552|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12553|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12554|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12555|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12556|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12557|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12558|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12559|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12560|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12561|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12562|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12563|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12564|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12565|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12566|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12567|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12568|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12569|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12570|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12571|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12572|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12573|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12574|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12575|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12576|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12577|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12578|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12579|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12580|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12581|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12582|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12583|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12584|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12585|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12586|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12587|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12588|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12589|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12590|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12591|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12592|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12593|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12594|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12595|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12596|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12597|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12598|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12599|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12600|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12601|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12602|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12603|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12604|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12605|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12606|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12607|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12608|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12609|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12610|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12611|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12612|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12613|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12614|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12615|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12616|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12617|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12618|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12619|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12620|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12621|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12622|NCT02469298|O1|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12623|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12624|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12625|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12626|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12627|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12628|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12629|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12630|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12631|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12632|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12633|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12634|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12635|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12636|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12637|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12638|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12639|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12640|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12641|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12642|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12643|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12644|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12645|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12646|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12647|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12648|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12649|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12650|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12651|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
12652|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
12653|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
12654|NCT02469298|O1|Outcome|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
12655|NCT02469298|O4|Outcome|Oseltamivir (OSV) 75 mg|Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12656|NCT02469298|O3|Outcome|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
12657|NCT02469298|O2|Outcome|Placebo (PBO)|Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12658|NCT02469298|O1|Outcome|Danirixin (DNX) 75 mg|Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
12659|NCT02469298|E4|Reported Event|Oseltamivir (OSV) 75 mg|Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
12660|NCT02469298|E3|Reported Event|Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg|Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
12661|NCT02469298|E2|Reported Event|Placebo (PBO)|Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
12662|NCT02469298|E1|Reported Event|Danirixin (DNX) 75 Milligram (mg)|Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
12663|NCT02469116|B1|Baseline|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
12664|NCT02469116|P1|Participant Flow|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
12665|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
12666|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
12667|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
12668|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
12669|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
12670|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
12671|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
12672|NCT02469116|E1|Reported Event|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
12673|NCT02468414|B3|Baseline|Total|Total of all reporting groups
12674|NCT02468414|B2|Baseline|Group B|TARGTEPO 35-45 IU/kg/day
12675|NCT02468414|B1|Baseline|Group A|TARGTEPO 18-25 IU/kg/day
12676|NCT02468414|P2|Participant Flow|Group B|35-45 IU/Kg/day
12677|NCT02468414|P1|Participant Flow|Group A|18-25 IU/Kg/day
12678|NCT02468414|O2|Outcome|Group B|TARGTEPO 35-45 IU/kg/day
12679|NCT02468414|O1|Outcome|Group A|TARGTEPO 18-25 IU/kg/day
12680|NCT02468414|E2|Reported Event|Group B|TARGTEPO 35-45 IU/kg/day
12681|NCT02468414|E1|Reported Event|Group A|TARGTEPO 18-25 IU/kg/day
12682|NCT02468154|B3|Baseline|Total|Total of all reporting groups
12683|NCT02468154|B2|Baseline|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane
standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
12684|NCT02468154|B1|Baseline|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
12685|NCT02468154|P2|Participant Flow|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane
standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
12781|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
13023|NCT02458768|B3|Baseline|Total|Total of all reporting groups
12686|NCT02468154|P1|Participant Flow|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
12687|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane
standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
12688|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
12689|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane
standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
12690|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
12691|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane
standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
12692|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
12693|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane
standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
12694|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
12695|NCT02468154|E2|Reported Event|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane
standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
12762|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12696|NCT02468154|E1|Reported Event|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
12697|NCT02467777|B3|Baseline|Total|Total of all reporting groups
12698|NCT02467777|B2|Baseline|Conductive Warming|"VitaHeat
VitaHeat"
12699|NCT02467777|B1|Baseline|Forced Air|"Bair Hugger
Bair Hugger"
12700|NCT02467777|P2|Participant Flow|Conductive Warming|"VitaHeat
VitaHeat"
12701|NCT02467777|P1|Participant Flow|Forced Air|"Bair Hugger
Bair Hugger"
12702|NCT02467777|O2|Outcome|Conductive Warming|"VitaHeat
VitaHeat"
12703|NCT02467777|O1|Outcome|Forced Air|"Bair Hugger
Bair Hugger"
12704|NCT02467777|E2|Reported Event|Conductive Warming|"VitaHeat
VitaHeat"
12705|NCT02467777|E1|Reported Event|Forced Air|"Bair Hugger
Bair Hugger"
12706|NCT02467491|B1|Baseline|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.
Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
12707|NCT02467491|P1|Participant Flow|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.
Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
12708|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.
Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
12709|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.
Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
12710|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.
Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
12711|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.
Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
12712|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.
Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
12713|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.
Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
12714|NCT02467491|E1|Reported Event|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.
Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
12715|NCT02467075|B3|Baseline|Total|Total of all reporting groups
12716|NCT02467075|B2|Baseline|Placebo (Normal Saline)|"Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.
Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan"
12763|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12764|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12717|NCT02467075|B1|Baseline|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.
Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan"
12718|NCT02467075|P2|Participant Flow|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT will be randomized to receive normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT. The fluids are given to placebo patients in order to minimize any differences in treatment between the treatment and placebo groups.
Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
12719|NCT02467075|P1|Participant Flow|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT. The function of the fluids is to minimize the effect of the contrast on their creatinine level.
Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
12720|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.
Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan"
12721|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.
Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan"
12722|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.
Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan"
13845|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
12723|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.
Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan"
12724|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT were randomized to receive weight-based normal saline instead of contrast material with the CT.
All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.
Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
12725|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT were randomized to receive weight-based low-osmolality iodinated contrast with the CT.
All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.
Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
12726|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT were randomized to receive weight-based normal saline instead of contrast material with the CT.
All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.
Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
12727|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT were randomized to receive weight-based low-osmolality iodinated contrast with the CT.
All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.
Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
12728|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT were randomized to receive weight-based normal saline instead of contrast material with the CT.
All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.
Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
12729|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT were randomized to receive weight-based low-osmolality iodinated contrast with the CT.
All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.
Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
12730|NCT02467075|O2|Outcome|Placebo (Normal Saline)|"Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.
Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan"
12731|NCT02467075|O1|Outcome|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.
Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan"
12732|NCT02467075|E2|Reported Event|Placebo (Normal Saline)|"Subjects scheduled for a clinical CT were randomized to receive weight-based normal saline instead of contrast material with the CT.
All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.
Placebo (Normal Saline): Patients will be randomized to receive IV normal saline (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
12733|NCT02467075|E1|Reported Event|Iopamidol 300 (Contrast)|"Subjects scheduled for a clinical CT were randomized to receive weight-based low-osmolality iodinated contrast with the CT.
All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least 3 hours before and 3 hours after the CT.
Iopamidol 300 (Contrast): Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, up to a max volume of 125 mL) with their CT scan"
12734|NCT02466425|B3|Baseline|Total|Total of all reporting groups
12735|NCT02466425|B2|Baseline|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
12736|NCT02466425|B1|Baseline|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
12737|NCT02466425|P2|Participant Flow|SHP465|Participants received SHP465 capsule (12.5 milligram [mg] during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
12738|NCT02466425|P1|Participant Flow|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
12739|NCT02466425|O2|Outcome|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
12740|NCT02466425|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
12741|NCT02466425|O2|Outcome|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
12742|NCT02466425|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
12743|NCT02466425|E2|Reported Event|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during dose maintenance phase) orally once daily for 4 weeks.
12744|NCT02466425|E1|Reported Event|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
12745|NCT02466412|B3|Baseline|Total|Total of all reporting groups
12746|NCT02466412|B2|Baseline|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:
Day -1 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of mCC)
Day 2 = Wash-out
Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
12747|NCT02466412|B1|Baseline|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:
Day -1 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of CHTP 1.1 M)
Day 2 = Wash-out
Day 3 = 2nd intervention (single product use of mCC)."
35483|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
12748|NCT02466412|P2|Participant Flow|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:
Day -1 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of mCC)
Day 2 = Wash-out
Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
12749|NCT02466412|P1|Participant Flow|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:
Day -1 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of CHTP 1.1 M)
Day 2 = Wash-out
Day 3 = 2nd intervention (single product use of mCC)."
12750|NCT02466412|O2|Outcome|Menthol Cigarette (mCC)|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of mCC.
12751|NCT02466412|O1|Outcome|CHTP 1.1 M|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of CHTP 1.1 M.
12752|NCT02466412|O2|Outcome|Menthol Cigarette (mCC)|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of mCC.
12753|NCT02466412|O1|Outcome|CHTP 1.1 M|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of CHTP 1.1 M.
12754|NCT02466412|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the CHTP 1.1 M at Admission but were not randomized in 1 of the 2 sequences as they were back-up subjects
12755|NCT02466412|E2|Reported Event|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:
Day -1 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of mCC)
Day 2 = Wash-out
Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
12756|NCT02466412|E1|Reported Event|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:
Day -1 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of CHTP 1.1 M)
Day 2 = Wash-out
Day 3 = 2nd intervention (single product use of mCC)."
12757|NCT02465866|B1|Baseline|Overall Subjects|
12758|NCT02465866|P4|Participant Flow|Sequence 4: DACB|"Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Dosing in 4 study periods was separated by a 14-day washout period"
12759|NCT02465866|P3|Participant Flow|Sequence 3: CDBA|"Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
Dosing in 4 study periods was separated by a 14-day washout period"
12760|NCT02465866|P2|Participant Flow|Sequence 2: BCAD|"Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Dosing in 4 study periods was separated by a 14-day washout period"
12761|NCT02465866|P1|Participant Flow|Sequence 1: ABDC|"Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Dosing in 4 study periods was separated by a 14-day washout period"
12765|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12766|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12767|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12768|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12769|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12770|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12771|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12772|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12773|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12774|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12775|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12776|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12777|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12778|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12779|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12780|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12782|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12783|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12784|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12785|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12786|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12787|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12788|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12789|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12790|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12791|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12792|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12793|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12794|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12795|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12796|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12797|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12798|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12799|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12800|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12801|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12802|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12803|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12804|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12805|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12806|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12807|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12808|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12809|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12810|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12811|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12812|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12813|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12814|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12815|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12816|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12817|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12818|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12819|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12820|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12821|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12822|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12823|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12824|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12825|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12826|NCT02465866|E4|Reported Event|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
12827|NCT02465866|E3|Reported Event|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
12828|NCT02465866|E2|Reported Event|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
12829|NCT02465866|E1|Reported Event|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
12830|NCT02465632|B4|Baseline|Total|Total of all reporting groups
12831|NCT02465632|B3|Baseline|Placebo|Placebo: Placebo topical gel
12832|NCT02465632|B2|Baseline|Reference|Reference: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
12833|NCT02465632|B1|Baseline|Test|Test: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
12834|NCT02465632|P3|Participant Flow|Placebo Topical Gel|Placebo: A thin layer of gel was applied to the entire affected areas on the face twice a day.
12835|NCT02465632|P2|Participant Flow|BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%|Reference: A thin layer of gel was applied to the entire affected areas on the face twice a day.
12836|NCT02465632|P1|Participant Flow|Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel|Test: A thin layer of gel was applied to the entire affected areas on the face twice a day.
12837|NCT02465632|O3|Outcome|Placebo|Placebo: Placebo Topical Gel
12838|NCT02465632|O2|Outcome|Reference|BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%
12839|NCT02465632|O1|Outcome|Test|Clindamycin and Benzoyl Peroxide Gel, 1%/5%
12840|NCT02465632|O3|Outcome|Placebo|Placebo: Placebo topical gel
12841|NCT02465632|O2|Outcome|Reference|BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%
12842|NCT02465632|O1|Outcome|Test|Clindamycin and Benzoyl Peroxide Gel, 1%/5%
12843|NCT02465632|E3|Reported Event|Placebo|Placebo topical gel
12844|NCT02465632|E2|Reported Event|Reference|BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
12845|NCT02465632|E1|Reported Event|Test|Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
12846|NCT02465489|B1|Baseline|Healthy Volunteers|"Subjects were randomized to receive five treatments in different orders:
deferiprone ER tablets under fasting conditions
deferiprone ER tablets under fed conditions
deferiprone ER tablets administered as half-tablets under fed conditions
Ferriprox IR tablets under fasting conditions
Ferriprox IR tablets under fed conditions"
12871|NCT02465489|E2|Reported Event|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12872|NCT02465489|E1|Reported Event|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12847|NCT02465489|P1|Participant Flow|Healthy Volunteers|"Subjects were randomized to receive the following five treatments in different orders, with a 7-day washout period between treatments::
A: Deferiprone ER tablets under fasting conditions B: Deferiprone ER tablets under fed conditions C: Deferiprone ER tablets administered as half-tablets under fed conditions D: Ferriprox IR tablets under fasting conditions E: Ferriprox IR tablets under fed conditions
The sequences were as follows;
Sequence 1 (n=4): A-B-E-C-D
Sequence 2 (n=4): B-C-A-D-E
Sequence 3 (n=4): C-D-B-E-A
Sequence 4 (n=4): D-E-C-A-B
Sequence 5 (n=4): E-A-D-B-C"
12848|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
12849|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
12850|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12851|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12852|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12853|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
12854|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
12855|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12941|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
12856|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12857|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12858|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
12859|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
12860|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12861|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12862|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12863|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
12864|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
12865|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12866|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12867|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12868|NCT02465489|E5|Reported Event|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
12869|NCT02465489|E4|Reported Event|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast
Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
12870|NCT02465489|E3|Reported Event|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast
Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
12873|NCT02465073|B4|Baseline|Total|Total of all reporting groups
13000|NCT02461693|E1|Reported Event|Caffeine|"One-time treatment with 200mg caffeine pill
Caffeine: 200mg delivered as pill; one-time dose"
12874|NCT02465073|B3|Baseline|Standard of Care|"This group will receive Standard of Care only.
Standard of Care Group: Subjects will receive Standard of Care only."
12875|NCT02465073|B2|Baseline|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.
NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
12876|NCT02465073|B1|Baseline|NXTSC|"This group will receive the NXTSC gel only.
NXTSC wound gel: Subjects will receive NXTSC wound gel only."
12877|NCT02465073|P3|Participant Flow|Standard of Care|"This group will receive Standard of Care only.
Standard of Care Group: Subjects will receive Standard of Care only."
12878|NCT02465073|P2|Participant Flow|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.
NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
12879|NCT02465073|P1|Participant Flow|NXTSC|"This group will receive the NXTSC gel only.
NXTSC wound gel: Subjects will receive NXTSC wound gel only."
12880|NCT02465073|O3|Outcome|Standard of Care|"This group will receive Standard of Care only.
Standard of Care Group: Subjects will receive Standard of Care only."
12881|NCT02465073|O2|Outcome|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.
NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
12882|NCT02465073|O1|Outcome|NXTSC|"This group will receive the NXTSC gel only.
NXTSC wound gel: Subjects will receive NXTSC wound gel only."
12883|NCT02465073|E3|Reported Event|Standard of Care|"This group will receive Standard of Care only.
Standard of Care Group: Subjects will receive Standard of Care only."
12884|NCT02465073|E2|Reported Event|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.
NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
12885|NCT02465073|E1|Reported Event|NXTSC|"This group will receive the NXTSC gel only.
NXTSC wound gel: Subjects will receive NXTSC wound gel only."
12886|NCT02463409|B1|Baseline|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.
Theophylline: 24 hour infusion of IV theophylline"
12887|NCT02463409|P1|Participant Flow|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.
Theophylline: 24 hour infusion of IV theophylline"
13151|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
12888|NCT02463409|O1|Outcome|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.
Theophylline: 24 hour infusion of IV theophylline"
12889|NCT02463409|O1|Outcome|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.
Theophylline: 24 hour infusion of IV theophylline"
12890|NCT02463409|O1|Outcome|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.
Theophylline: 24 hour infusion of IV theophylline"
12891|NCT02463409|E1|Reported Event|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.
Theophylline: 24 hour infusion of IV theophylline. All patients who enrolled in the study are included in this group (excluding screen fails)."
12892|NCT02463331|B3|Baseline|Total|Total of all reporting groups
12893|NCT02463331|B2|Baseline|Azathioprine Plus Prednisone|"azathioprine in variable doses (50-150mg/day) associated to prednisone in variable doses
prednisone: Prednisone 5-15 mg/day until the end of the study
azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
12894|NCT02463331|B1|Baseline|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses
Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study
prednisone: Prednisone 5-15 mg/day until the end of the study"
12895|NCT02463331|P2|Participant Flow|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses
prednisone: Prednisone 5-15 mg/day until the end of the study
azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
12896|NCT02463331|P1|Participant Flow|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses
Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study
prednisone: Prednisone 5-15 mg/day until the end of the study"
12897|NCT02463331|O2|Outcome|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses
prednisone: Prednisone 5-15 mg/day until the end of the study
azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
12898|NCT02463331|O1|Outcome|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses
Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study
prednisone: Prednisone 5-15 mg/day until the end of the study"
12899|NCT02463331|O2|Outcome|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses
prednisone: Prednisone 5-15 mg/day until the end of the study
azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
12900|NCT02463331|O1|Outcome|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses
Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study
prednisone: Prednisone 5-15 mg/day until the end of the study"
12901|NCT02463331|E2|Reported Event|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses
prednisone: Prednisone 5-15 mg/day until the end of the study
azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
12902|NCT02463331|E1|Reported Event|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses
Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study
prednisone: Prednisone 5-15 mg/day until the end of the study"
12903|NCT02463227|B1|Baseline|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.
VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.
Administered over about 30 to 60 minutes using a volumetric pump."
12904|NCT02463227|P1|Participant Flow|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.
VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.
Administered over about 30 to 60 minutes using a volumetric pump."
12994|NCT02461693|O1|Outcome|Caffeine|"One-time treatment with 200mg caffeine pill
Caffeine: 200mg delivered as pill; one-time dose"
12995|NCT02461693|O2|Outcome|Placebo|"One-time treatment with lactose-based placebo pill
Placebo"
12905|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.
VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.
Administered over about 30 to 60 minutes using a volumetric pump."
12906|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.
VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.
Administered over about 30 to 60 minutes using a volumetric pump."
12907|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.
VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.
Administered over about 30 to 60 minutes using a volumetric pump."
12908|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.
VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.
Administered over about 30 to 60 minutes using a volumetric pump."
12909|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.
VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.
Administered over about 30 to 60 minutes using a volumetric pump."
12910|NCT02463227|E1|Reported Event|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.
VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.
Administered over about 30 to 60 minutes using a volumetric pump."
12911|NCT02463097|B1|Baseline|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
12912|NCT02463097|P1|Participant Flow|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
12969|NCT02461992|B1|Baseline|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12913|NCT02463097|O1|Outcome|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
12914|NCT02463097|O1|Outcome|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
12915|NCT02463097|O1|Outcome|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
12916|NCT02463097|E1|Reported Event|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
12917|NCT02462473|B1|Baseline|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
12918|NCT02462473|P1|Participant Flow|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
12919|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
12920|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
12921|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
12922|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
12923|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
12924|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
12925|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
12926|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
12927|NCT02462473|E1|Reported Event|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
12928|NCT02462291|B3|Baseline|Total|Total of all reporting groups
12929|NCT02462291|B2|Baseline|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
12930|NCT02462291|B1|Baseline|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12931|NCT02462291|P2|Participant Flow|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
12996|NCT02461693|O1|Outcome|Caffeine|"One-time treatment with 200mg caffeine pill
Caffeine: 200mg delivered as pill; one-time dose"
12932|NCT02462291|P1|Participant Flow|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12933|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
12934|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12935|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
12936|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12937|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
12938|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12939|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
12940|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12942|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12943|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
12944|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12945|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
12946|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12947|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
12948|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12949|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
12950|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12951|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
12952|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12953|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
12954|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12955|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
12956|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12957|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
12958|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12959|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
12997|NCT02461693|O2|Outcome|Placebo|"One-time treatment with lactose-based placebo pill
Placebo"
12998|NCT02461693|O1|Outcome|Caffeine|"One-time treatment with 200mg caffeine pill
Caffeine: 200mg delivered as pill; one-time dose"
12960|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12961|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
12962|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12963|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
12964|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12965|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
12966|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
12967|NCT02462291|E2|Reported Event|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
12968|NCT02462291|E1|Reported Event|Experimental Group (TR)|"A group of 82 patients with AD will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
13017|NCT02460458|B1|Baseline|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
12970|NCT02461992|P1|Participant Flow|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12971|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12972|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12973|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12974|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12975|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12976|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12977|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12978|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12979|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12980|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12981|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12982|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12983|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12984|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12985|NCT02461992|E1|Reported Event|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
12986|NCT02461693|B3|Baseline|Total|Total of all reporting groups
12987|NCT02461693|B2|Baseline|Placebo|"One-time treatment with lactose-based placebo pill
Placebo"
12988|NCT02461693|B1|Baseline|Caffeine|"One-time treatment with 200mg caffeine pill
Caffeine: 200mg delivered as pill; one-time dose"
12989|NCT02461693|P2|Participant Flow|Placebo|"One-time treatment with lactose-based placebo pill
Placebo"
12990|NCT02461693|P1|Participant Flow|Caffeine|"One-time treatment with 200mg caffeine pill
Caffeine: 200mg delivered as pill; one-time dose"
12991|NCT02461693|O2|Outcome|Placebo|"One-time treatment with lactose-based placebo pill
Placebo"
12992|NCT02461693|O1|Outcome|Caffeine|"One-time treatment with 200mg caffeine pill
Caffeine: 200mg delivered as pill; one-time dose"
12993|NCT02461693|O2|Outcome|Placebo|"One-time treatment with lactose-based placebo pill
Placebo"
13001|NCT02461290|B1|Baseline|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
13002|NCT02461290|P1|Participant Flow|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated follicular lymphoma (FL) received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included cyclophosphamide, vincristine, and prednisone (CVP); cyclophosphamide, doxorubin, vincristine, and predisone (CHOP); or fludarabine, cyclophosphamide, and mitoxantrone (FCM). Rituximab was administered as 375 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
13003|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
13004|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
13018|NCT02460458|P1|Participant Flow|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
13019|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
13020|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
13005|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
13006|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
13007|NCT02461290|E1|Reported Event|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
13008|NCT02460822|B1|Baseline|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application"
13009|NCT02460822|P1|Participant Flow|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application"
13010|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application"
13011|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application"
13012|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application"
13047|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
13137|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13013|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application"
13014|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application"
13015|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application"
13016|NCT02460822|E1|Reported Event|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.
MyChemoCare iPad application"
13024|NCT02458768|B2|Baseline|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.
Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).
Menopur® Inj."
13025|NCT02458768|B1|Baseline|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.
Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).
IVF-M HP Inj."
13026|NCT02458768|P2|Participant Flow|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.
Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).
Menopur® Inj."
13027|NCT02458768|P1|Participant Flow|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.
Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).
IVF-M HP Inj."
13028|NCT02458768|O2|Outcome|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.
Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).
Menopur® Inj."
13029|NCT02458768|O1|Outcome|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.
Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).
IVF-M HP Inj."
13030|NCT02458768|E2|Reported Event|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.
Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).
Menopur® Inj."
13031|NCT02458768|E1|Reported Event|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.
Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).
IVF-M HP Inj."
13032|NCT02458365|B3|Baseline|Total|Total of all reporting groups
13033|NCT02458365|B2|Baseline|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
13074|NCT02457247|B2|Baseline|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
13075|NCT02457247|B1|Baseline|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
13034|NCT02458365|B1|Baseline|Intevention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
13035|NCT02458365|P2|Participant Flow|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
13036|NCT02458365|P1|Participant Flow|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
13037|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
13038|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
13224|NCT02454283|P2|Participant Flow|Placebo|"identically matching placebo capsules, orally, single-dose
Placebo"
13039|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
13040|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
13041|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
13042|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
13043|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
13044|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
13045|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
13046|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
21118|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
13048|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
13049|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
13050|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
13051|NCT02458365|O2|Outcome|Comparison: Health in Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
13052|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
13053|NCT02458365|E2|Reported Event|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
13054|NCT02458365|E1|Reported Event|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
13055|NCT02457728|B1|Baseline|Inguinal Herniation|"In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.
LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TransAbdominalPrePeritoneal (TAPP) repair."
13056|NCT02457728|P1|Participant Flow|Inguinal Herniation|"In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.
LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair."
13057|NCT02457728|O1|Outcome|Single-port TAPP Repair|LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair using a single-port approach.
13058|NCT02457728|E1|Reported Event|TAPP Repair|LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
13059|NCT02457611|B1|Baseline|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
13060|NCT02457611|P1|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks
13061|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
13062|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
13063|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
13064|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
13065|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
13066|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
13067|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
13068|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
13069|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
13070|NCT02457611|E1|Reported Event|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
13071|NCT02457247|B5|Baseline|Total|Total of all reporting groups
13072|NCT02457247|B4|Baseline|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
13073|NCT02457247|B3|Baseline|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
13135|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13076|NCT02457247|P4|Participant Flow|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
13077|NCT02457247|P3|Participant Flow|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
13078|NCT02457247|P2|Participant Flow|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
13079|NCT02457247|P1|Participant Flow|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
13080|NCT02457247|O4|Outcome|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
13081|NCT02457247|O3|Outcome|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
13082|NCT02457247|O2|Outcome|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
13083|NCT02457247|O1|Outcome|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
13084|NCT02457247|O4|Outcome|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
13085|NCT02457247|O3|Outcome|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
13086|NCT02457247|O2|Outcome|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
13087|NCT02457247|O1|Outcome|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
13088|NCT02457247|O6|Outcome|Test Group 2: Total|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, for 14 days in either Period 1 or 2 and Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, for 14 days in either Period 1 or 2.
13089|NCT02457247|O5|Outcome|Test Group 1: Total|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2 and Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2.
13090|NCT02457247|O4|Outcome|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
13091|NCT02457247|O3|Outcome|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
13092|NCT02457247|O2|Outcome|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
13093|NCT02457247|O1|Outcome|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
13094|NCT02457247|E4|Reported Event|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
13095|NCT02457247|E3|Reported Event|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
13096|NCT02457247|E2|Reported Event|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
13097|NCT02457247|E1|Reported Event|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
13098|NCT02455050|B5|Baseline|Total|Total of all reporting groups
13099|NCT02455050|B4|Baseline|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13100|NCT02455050|B3|Baseline|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13101|NCT02455050|B2|Baseline|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13102|NCT02455050|B1|Baseline|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13136|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
21119|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
13103|NCT02455050|P4|Participant Flow|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13104|NCT02455050|P3|Participant Flow|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13105|NCT02455050|P2|Participant Flow|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13106|NCT02455050|P1|Participant Flow|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13107|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13108|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13109|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13110|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13111|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13112|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13113|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
35484|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
13114|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13115|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13116|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13117|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13118|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13119|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13120|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13121|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13122|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13123|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13124|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13125|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13126|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13127|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13128|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13129|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13130|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13131|NCT02455050|O1|Outcome|New Eye Drop Formulation and Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Genteal® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13132|NCT02455050|O1|Outcome|New Eye Drop Formulation and Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13133|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13134|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13138|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13139|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13140|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13141|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13142|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13143|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13144|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13145|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13146|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13147|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13148|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13149|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13150|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13846|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13152|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13153|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13154|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
13155|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13156|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13157|NCT02455050|O4|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13158|NCT02455050|O3|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13159|NCT02455050|O2|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13160|NCT02455050|O1|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13161|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
13162|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.
13163|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
13164|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.
13165|NCT02455050|E4|Reported Event|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13166|NCT02455050|E3|Reported Event|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13167|NCT02455050|E2|Reported Event|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13168|NCT02455050|E1|Reported Event|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
13169|NCT02454959|B1|Baseline|MITT Population|The Modified ITT (MITT) Population is a subset of the ITT Population including subjects who received treatment and had post dose efficacy data from both Treatment Periods. Data judged to be impacted by major protocol deviations were determined prior to unblinding and excluded. Statistical tabulations and analyses are by randomized treatment, but data obtained after subjects received an incorrect treatment have been excluded from the affected periods.
13171|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
13172|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
13173|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
13174|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
13175|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
13176|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
13177|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
13178|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
13179|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
13180|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
13181|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
13182|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
13183|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
35485|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
13184|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
13185|NCT02454959|E2|Reported Event|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
13186|NCT02454959|E1|Reported Event|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
13187|NCT02454608|B3|Baseline|Total|Total of all reporting groups
13188|NCT02454608|B2|Baseline|Control|"Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
13189|NCT02454608|B1|Baseline|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
13190|NCT02454608|P2|Participant Flow|Control|"Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
13191|NCT02454608|P1|Participant Flow|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
13192|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
13193|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
13194|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
13195|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
13196|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
13197|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
13198|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
13199|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
13200|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
13225|NCT02454283|P1|Participant Flow|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Vanoxerine HCl"
13226|NCT02454283|O2|Outcome|Placebo|"identically matching placebo capsules, orally, single-dose
Placebo"
13227|NCT02454283|O1|Outcome|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Vanoxerine HCl"
13228|NCT02454283|O2|Outcome|Placebo|"identically matching placebo capsules, orally, single-dose
Placebo"
13201|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
13202|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
13203|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
13204|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
13205|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
13206|NCT02454608|E2|Reported Event|Control|"Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
13207|NCT02454608|E1|Reported Event|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
13208|NCT02454296|B3|Baseline|Total|Total of all reporting groups
13209|NCT02454296|B2|Baseline|Sham Block Group|Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
13210|NCT02454296|B1|Baseline|Paracervical Block Group|Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
13211|NCT02454296|P2|Participant Flow|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle
Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
13212|NCT02454296|P1|Participant Flow|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
13213|NCT02454296|O2|Outcome|Sham Block Group|Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
13214|NCT02454296|O1|Outcome|Paracervical Block Group|Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
13215|NCT02454296|O2|Outcome|Sham Block Group|Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
13216|NCT02454296|O1|Outcome|Paracervical Block Group|Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
13217|NCT02454296|O2|Outcome|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle
Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
13218|NCT02454296|O1|Outcome|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
13219|NCT02454296|E2|Reported Event|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle
Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
13220|NCT02454296|E1|Reported Event|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
13221|NCT02454283|B3|Baseline|Total|Total of all reporting groups
13222|NCT02454283|B2|Baseline|Placebo|"identically matching placebo capsules, orally, single-dose
Placebo"
13223|NCT02454283|B1|Baseline|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Vanoxerine HCl"
35486|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
13229|NCT02454283|O1|Outcome|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Vanoxerine HCl"
13230|NCT02454283|E2|Reported Event|Placebo|"identically matching placebo capsules, orally, single-dose
Placebo"
13231|NCT02454283|E1|Reported Event|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Vanoxerine HCl"
13232|NCT02454127|B5|Baseline|Total|Total of all reporting groups
13233|NCT02454127|B4|Baseline|Ornish Diet|"Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year"
13234|NCT02454127|B3|Baseline|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year"
13235|NCT02454127|B2|Baseline|Zone Diet|"Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year"
13236|NCT02454127|B1|Baseline|Atkins Diet|"Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year"
13237|NCT02454127|P4|Participant Flow|Ornish Diet|"Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year"
13238|NCT02454127|P3|Participant Flow|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year"
13239|NCT02454127|P2|Participant Flow|Zone Diet|"Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year"
13240|NCT02454127|P1|Participant Flow|Atkins Diet|"Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year"
13241|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year"
13242|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year"
13243|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year"
13244|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year"
13245|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year"
13246|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year"
13247|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year"
13248|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year"
13249|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year"
13250|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year"
13251|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year"
13252|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year"
13253|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year"
13254|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year"
13255|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year"
13256|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year"
13257|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year"
13258|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year"
13259|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year"
13260|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year"
13261|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year"
13262|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year"
13263|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year"
13264|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year"
13265|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year"
13266|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year"
13267|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year"
13268|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year"
13269|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year"
13270|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year"
13271|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year"
13272|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year"
13273|NCT02454127|E4|Reported Event|Ornish Diet|"Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year"
13274|NCT02454127|E3|Reported Event|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year"
13275|NCT02454127|E2|Reported Event|Zone Diet|"Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year"
13276|NCT02454127|E1|Reported Event|Atkins Diet|"Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year"
13277|NCT02454101|B3|Baseline|Total|Total of all reporting groups
13278|NCT02454101|B2|Baseline|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13279|NCT02454101|B1|Baseline|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13280|NCT02454101|P2|Participant Flow|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13281|NCT02454101|P1|Participant Flow|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13282|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13283|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13284|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13285|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13286|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13287|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13288|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13289|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13290|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13291|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13292|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13293|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13294|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13295|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13296|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13297|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13298|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13299|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13300|NCT02454101|E2|Reported Event|Delayed Cord Clamping|"delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate"
13301|NCT02454101|E1|Reported Event|Cord Milking|"milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds"
13302|NCT02453581|B1|Baseline|Randomised Participants|Twenty-four male and female subjects were enrolled in the study.
13303|NCT02453581|P3|Participant Flow|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
13304|NCT02453581|P2|Participant Flow|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
13305|NCT02453581|P1|Participant Flow|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
13306|NCT02453581|O1|Outcome|OZ439 500mg Arm|Cohort 3 - OZ439 500mg
13307|NCT02453581|O3|Outcome|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
13308|NCT02453581|O2|Outcome|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
13309|NCT02453581|O1|Outcome|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
13310|NCT02453581|O3|Outcome|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
13311|NCT02453581|O2|Outcome|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
13312|NCT02453581|O1|Outcome|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
13313|NCT02453581|O8|Outcome|OZ439 500mg - R024|Cohort 3 - OZ439 500mg - Subject R024
13314|NCT02453581|O7|Outcome|OZ439 500mg - R023|Cohort 3 - OZ439 500mg - Subject R023
13315|NCT02453581|O6|Outcome|OZ439 500mg - R022|Cohort 3 - OZ439 500mg - Subject R022
13316|NCT02453581|O5|Outcome|OZ439 500mg - R021|Cohort 3 - OZ439 500mg - Subject R021
13317|NCT02453581|O4|Outcome|OZ439 500mg - R020|Cohort 3 - OZ439 500mg - Subject R020
13318|NCT02453581|O3|Outcome|OZ439 500mg - R019|Cohort 3 - OZ439 500mg - Subject R019
13319|NCT02453581|O2|Outcome|OZ439 500mg - R018|Cohort 3 - OZ439 500mg - Subject R018
13320|NCT02453581|O1|Outcome|OZ439 500mg - R017|Cohort 3 - OZ439 500mg - Subject R017
13321|NCT02453581|E3|Reported Event|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
13322|NCT02453581|E2|Reported Event|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
13323|NCT02453581|E1|Reported Event|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
13324|NCT02452944|B3|Baseline|Total|Total of all reporting groups
13325|NCT02452944|B2|Baseline|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at 0.3mA, 10mL of local anesthetics was injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
13326|NCT02452944|B1|Baseline|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)
The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, another 5mL of LA was injected.
After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’."
13385|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
35487|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
13327|NCT02452944|P2|Participant Flow|US-NS Group|"ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group)
The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics (LA;1.5% lidocaine + epi 1:200,000) were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected."
13328|NCT02452944|P1|Participant Flow|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)
The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis muscles. 10mL of local anesthetics (LA; 1.5% lidocaine + epi 1:200,000) were injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus muscles, another 5mL of LA was injected.
After that, the needle was reinserted to the same spots attached with nerve stimulator for confirming the block. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’."
13329|NCT02452944|O2|Outcome|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at 0.3mA, 10mL of local anesthetics were injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
13330|NCT02452944|O1|Outcome|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)
The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, another 5mL of LA was injected.
After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.
nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block
ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run."
13331|NCT02452944|O2|Outcome|US-NS Group|"ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block
ultrasound: we did obturator nerve block with ultrasound guided m"
13368|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13369|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13370|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13371|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13372|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13332|NCT02452944|O1|Outcome|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)
The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.
After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.
nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block
ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerv"
13333|NCT02452944|E2|Reported Event|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis muscles. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
13386|NCT02451150|E2|Reported Event|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13387|NCT02451150|E1|Reported Event|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13388|NCT02450799|B4|Baseline|Total|Total of all reporting groups
13389|NCT02450799|B3|Baseline|PMMA|Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
13390|NCT02450799|B2|Baseline|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
13391|NCT02450799|B1|Baseline|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
13334|NCT02452944|E1|Reported Event|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)
The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.
After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.
nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block
ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run."
13335|NCT02451150|B3|Baseline|Total|Total of all reporting groups
13336|NCT02451150|B2|Baseline|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13337|NCT02451150|B1|Baseline|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13338|NCT02451150|P2|Participant Flow|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13339|NCT02451150|P1|Participant Flow|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13340|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13341|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13342|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13343|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13344|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13345|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13346|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13347|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13348|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13349|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13350|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13351|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13352|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13353|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13354|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13355|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13356|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13357|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13358|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13359|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13360|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13361|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13362|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13363|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13364|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13365|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13366|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13367|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13373|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13374|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13375|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13376|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13377|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13378|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13379|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13380|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13381|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13382|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
13383|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
13384|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
35488|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
13392|NCT02450799|P3|Participant Flow|PMMA|Polymethylmethacrylate (PMMA) IOL, prior implantation (1994-2000) in one or both eyes
13393|NCT02450799|P2|Participant Flow|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
13394|NCT02450799|P1|Participant Flow|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
13395|NCT02450799|O3|Outcome|PMMA|Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
13396|NCT02450799|O2|Outcome|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
13397|NCT02450799|O1|Outcome|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
13398|NCT02450799|E6|Reported Event|PMMA (Prospective)|Subjects with prior implantation of PMMA IOL who experienced an AE with onset after the Informed Consent acquisition
13399|NCT02450799|E5|Reported Event|Silicone (Prospective)|Subjects with prior implantation of Silicone IOL who experienced an AE with onset after the Informed Consent acquisition
13400|NCT02450799|E4|Reported Event|AcrySof (Prospective)|Subjects with prior implantation of acrylic IOL who experienced an AE with onset after the Informed Consent acquisition
13401|NCT02450799|E3|Reported Event|PMMA (Retrospective)|Subjects with prior implantation of PMMA IOL who experienced an AE related to decrease of BCVA in the study eye
13402|NCT02450799|E2|Reported Event|Silicone (Retrospective)|Subjects with prior implantation of Silicone IOL who experienced an AE related to decrease of BCVA in the study eye
13403|NCT02450799|E1|Reported Event|AcrySof (Retrospective)|Subjects with prior implantation of acrylic IOL who experienced an AE related to decrease of BCVA in the study eye
13404|NCT02450747|B1|Baseline|Multi-focal(Etafilcon A)|All subjects wore the Test Contact Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
13405|NCT02450747|P1|Participant Flow|Multi-focal(Etafilcon A)|All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks.
13406|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
13407|NCT02450747|O1|Outcome|Baseline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
13408|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
13409|NCT02450747|O1|Outcome|Basline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
13410|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study lens, Multi-focal (etafilcon A ) as daily wear modality over a period of four weeks.
13411|NCT02450747|O1|Outcome|Baseline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
13412|NCT02450747|E1|Reported Event|Multi-focal(Etafilcon A)|All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks.
13413|NCT02449902|B3|Baseline|Total|Total of all reporting groups
13414|NCT02449902|B2|Baseline|Placebo Daily for 14 Days|Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
13415|NCT02449902|B1|Baseline|Estradiol 10 μg Daily for 14 Days|Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
13416|NCT02449902|P2|Participant Flow|Placebo|Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
13417|NCT02449902|P1|Participant Flow|TX-12-004-HR 10μg|Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
13418|NCT02449902|O2|Outcome|Placebo|Control treatment group.
13419|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
13420|NCT02449902|O2|Outcome|Treatment 2|"Placebo vaginal softgel capsule
placebo: 1 placebo capsule inserted vaginally for 14 days."
13421|NCT02449902|O1|Outcome|Treatment 1|"Estradiol 10 μg vaginal softgel capsule
Estradiol: 1 10 µg capsule inserted vaginally for 14 days."
13422|NCT02449902|O2|Outcome|Placebo|Control treatment group.
13423|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
13424|NCT02449902|O2|Outcome|Placebo|Control treatment group.
13425|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
13426|NCT02449902|O2|Outcome|Placebo|Control treatment group.
13427|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
13428|NCT02449902|O2|Outcome|Placebo|Control treatment group.
13429|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
13430|NCT02449902|O2|Outcome|Placebo|Control treatment group.
13431|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
13432|NCT02449902|O2|Outcome|Placebo|Control treatment group.
13433|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
13434|NCT02449902|O2|Outcome|Placebo|Control treatment group.
13435|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
13436|NCT02449902|O2|Outcome|Placebo|Control treatment group.
13437|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
13438|NCT02449902|E2|Reported Event|Placebo|Control treatment group.
13439|NCT02449902|E1|Reported Event|TX-12-004-HR|Active treatment group.
13440|NCT02449798|B1|Baseline|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13554|NCT02447458|B1|Baseline|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13555|NCT02447458|P6|Participant Flow|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
13441|NCT02449798|P1|Participant Flow|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 Blood Control (BC) peripheral intravenous (PIV) device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13442|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13443|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13444|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13445|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13446|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13447|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13448|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13449|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13450|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13480|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13642|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13451|NCT02449798|E1|Reported Event|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
13452|NCT02449356|B3|Baseline|Total|Total of all reporting groups
13453|NCT02449356|B2|Baseline|Traditional Endotracheal Tube(TT)|We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the traditional endotracheal tube group(TT), in which group the patients were intubated with the routine endotracheal tube.
13454|NCT02449356|B1|Baseline|Prone Position Endotracheal Tube(PPT)|We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the prone position endotracheal tube group(PPT), in which group the patients were intubated with the custom-designed endotracheal tube.
13455|NCT02449356|P2|Participant Flow|Prone Position Endotracheal Tube(PPT)|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.
prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
13456|NCT02449356|P1|Participant Flow|Traditional Endotracheal Tube(TT)|the subjects of this arm are given the routine endotracheal tube.
13457|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.
prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
13458|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
13556|NCT02447458|P5|Participant Flow|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13459|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.
prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
13460|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
13461|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.
prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
13462|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
13463|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.
prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
13464|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
13465|NCT02449356|O2|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
13466|NCT02449356|O1|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.
prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
13467|NCT02449356|O2|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
13468|NCT02449356|O1|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.
prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
13469|NCT02449356|E2|Reported Event|Traditional Endotracheal Tube|there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia.
13470|NCT02449356|E1|Reported Event|Prone Position Endotracheal Tube|there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia.
13471|NCT02449044|B1|Baseline|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13472|NCT02449044|P1|Participant Flow|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13473|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13474|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13475|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13476|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13477|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13478|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13479|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13643|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13481|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13482|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13483|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13484|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13485|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13486|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13487|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13488|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13489|NCT02449044|E1|Reported Event|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
13490|NCT02448914|B1|Baseline|TRIGEL and Duodopa in Randomized Order|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone). Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
13491|NCT02448914|P2|Participant Flow|Duodopa First, Then TRIGEL|"First Intervention (Day 1): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
Second Intervention (Day 2): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).
Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
13492|NCT02448914|P1|Participant Flow|TRIGEL First, Then Duodopa|"First Intervention (Day 1): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).
Second Intervention (Day 2): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
13493|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
13494|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.
Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
13495|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
13542|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13543|NCT02448563|O2|Outcome|Control|Standard of care - one counseling visit with a study dietitian
13825|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13496|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
13497|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
13498|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.
Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
13557|NCT02447458|P4|Participant Flow|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
14053|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
13499|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
13500|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
13501|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
13502|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
13503|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
13504|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.
Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
13505|NCT02448914|E2|Reported Event|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
13506|NCT02448914|E1|Reported Event|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).
All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).
The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
13507|NCT02448862|B3|Baseline|Total|Total of all reporting groups
21120|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
13508|NCT02448862|B2|Baseline|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13509|NCT02448862|B1|Baseline|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13558|NCT02447458|P3|Participant Flow|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13559|NCT02447458|P2|Participant Flow|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13560|NCT02447458|P1|Participant Flow|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
14592|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
13510|NCT02448862|P2|Participant Flow|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13511|NCT02448862|P1|Participant Flow|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13512|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13513|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13514|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13515|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13516|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13517|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13544|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13518|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13519|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13520|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13521|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13522|NCT02448862|E2|Reported Event|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13523|NCT02448862|E1|Reported Event|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.
Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
13524|NCT02448563|B5|Baseline|Total|Total of all reporting groups
13525|NCT02448563|B4|Baseline|Control Non-completers|"Non-completers
Standard of care - one counseling visit with a study dietitian"
13526|NCT02448563|B3|Baseline|Control Completers|Standard of care - one counseling visit with a study dietitian
13527|NCT02448563|B2|Baseline|Intervention Non-completers|"Non-completers
Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13528|NCT02448563|B1|Baseline|Intervention Completers|"Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13529|NCT02448563|P2|Participant Flow|Control|Standard of care - one counseling visit with a study dietitian
13530|NCT02448563|P1|Participant Flow|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13531|NCT02448563|O4|Outcome|Control Non-completers|"Non-completers
Standard of care - one counseling visit with a study dietitian"
13532|NCT02448563|O3|Outcome|Control Completers|Standard of care - one counseling visit with a study dietitian
13533|NCT02448563|O2|Outcome|Intervention Non-completers|"Non-completers
Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13534|NCT02448563|O1|Outcome|Intervention Completers|"Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13535|NCT02448563|O2|Outcome|Control|Standard of care - one counseling visit with a study dietitian
13536|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13537|NCT02448563|O2|Outcome|Control|Standard of care - one counseling visit with a study dietitian
13538|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13539|NCT02448563|O2|Outcome|Control|Standard of care - one counseling visit with a study dietitian
13540|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13541|NCT02448563|O2|Outcome|Control|Standard of care - one counseling visit with a study dietitian
21121|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
13545|NCT02448563|O1|Outcome|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13546|NCT02448563|E2|Reported Event|Control|Standard of care - one counseling visit with a study dietitian
13547|NCT02448563|E1|Reported Event|Intervention|"Weekly, in-person, support groups providing nutrition and physical activity education
Nutrition and physical activity education: Eight weekly in-person groups"
13548|NCT02447458|B7|Baseline|Total|Total of all reporting groups
13549|NCT02447458|B6|Baseline|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
13550|NCT02447458|B5|Baseline|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13551|NCT02447458|B4|Baseline|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13552|NCT02447458|B3|Baseline|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13553|NCT02447458|B2|Baseline|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13561|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13562|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13563|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13564|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13565|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13566|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13567|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13568|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13569|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13570|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13571|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13572|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13573|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13574|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13575|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13576|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13577|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13578|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13579|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13580|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13581|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13582|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13583|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13584|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13585|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13586|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13587|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13588|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13589|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13590|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13591|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13592|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13593|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13594|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13595|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13596|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13597|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13598|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13599|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13600|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13601|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13602|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13603|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13604|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13605|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13606|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13607|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13608|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
35489|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
13609|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13610|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13611|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13612|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13613|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13614|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13615|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13616|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13617|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
13618|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13619|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13620|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13621|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13622|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13623|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13624|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13625|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
13626|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13627|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13628|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13629|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13630|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13631|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13632|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13633|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
13634|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13635|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13636|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13637|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13638|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13639|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13640|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13641|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
13644|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13645|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13646|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13647|NCT02447458|E8|Reported Event|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13648|NCT02447458|E7|Reported Event|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13649|NCT02447458|E6|Reported Event|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
13650|NCT02447458|E5|Reported Event|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
13651|NCT02447458|E4|Reported Event|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
13652|NCT02447458|E3|Reported Event|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
13653|NCT02447458|E2|Reported Event|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
13654|NCT02447458|E1|Reported Event|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
13655|NCT02447432|B3|Baseline|Total|Total of all reporting groups
13715|NCT02447029|E2|Reported Event|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block
standard lidocaine paracervical block: 1% lidocaine paracervical injection"
13716|NCT02447029|E1|Reported Event|Active Comparator|"Drug: vaginal 2% Xylocaine
vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
13717|NCT02446990|B3|Baseline|Total|Total of all reporting groups
13656|NCT02447432|B2|Baseline|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of Synflorix™ vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh).
13657|NCT02447432|B1|Baseline|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh).
13658|NCT02447432|P2|Participant Flow|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13659|NCT02447432|P1|Participant Flow|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13660|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13661|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13662|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13704|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine
vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
13705|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block
standard lidocaine paracervical block: 1% lidocaine paracervical injection"
13706|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine
vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
13663|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13664|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13718|NCT02446990|B2|Baseline|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13719|NCT02446990|B1|Baseline|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13665|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13666|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13667|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13668|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13669|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13670|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13671|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13672|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13707|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block
standard lidocaine paracervical block: 1% lidocaine paracervical injection"
13826|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13673|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13674|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13675|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13676|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13677|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13678|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13679|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13680|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13681|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13682|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13708|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine
vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
13827|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13683|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13684|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13685|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13686|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13687|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13688|NCT02447432|E2|Reported Event|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13689|NCT02447432|E1|Reported Event|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
13690|NCT02447133|B1|Baseline|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device
3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
13691|NCT02447133|P1|Participant Flow|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device
3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
13692|NCT02447133|O3|Outcome|6x6 Disc Scan|TopQ of 6x6 Disc Scan
13693|NCT02447133|O2|Outcome|6x6 Macula Scan|TopQ of 6x6 Macular Scan
13694|NCT02447133|O1|Outcome|12x9 Wide Scan|TopQ of 12x9 Wide Scan
13695|NCT02447133|E1|Reported Event|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device
3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
13696|NCT02447029|B3|Baseline|Total|Total of all reporting groups
13697|NCT02447029|B2|Baseline|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block
standard lidocaine paracervical block: 1% lidocaine paracervical injection"
13698|NCT02447029|B1|Baseline|Active Comparator|"Drug: vaginal 2% Xylocaine
vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
13699|NCT02447029|P2|Participant Flow|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block
standard lidocaine paracervical block: 1% lidocaine paracervical injection"
13700|NCT02447029|P1|Participant Flow|Active Comparator|"Drug: vaginal 2% Xylocaine
vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
13701|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block
standard lidocaine paracervical block: 1% lidocaine paracervical injection"
13702|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine
vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
13703|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block
standard lidocaine paracervical block: 1% lidocaine paracervical injection"
13709|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block
standard lidocaine paracervical block: 1% lidocaine paracervical injection"
13710|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine
vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
13711|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block
standard lidocaine paracervical block: 1% lidocaine paracervical injection"
13712|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine
vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
13713|NCT02447029|O2|Outcome|Standard Lidocaine Paracervical Block|"standard lidocaine paracervical block
standard lidocaine paracervical block: 1% lidocaine paracervical injection"
13714|NCT02447029|O1|Outcome|Active Comparator|"Drug: vaginal 2% Xylocaine
vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block"
13839|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13720|NCT02446990|P2|Participant Flow|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13721|NCT02446990|P1|Participant Flow|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13722|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13723|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13724|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13725|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13726|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13727|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13728|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13729|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13730|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13731|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13732|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13733|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13734|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13735|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13736|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13737|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13738|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13739|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13740|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13741|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13742|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13743|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13744|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13745|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13746|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13747|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13748|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13749|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13750|NCT02446990|E2|Reported Event|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13751|NCT02446990|E1|Reported Event|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
13752|NCT02446613|B3|Baseline|Total|Total of all reporting groups
13753|NCT02446613|B2|Baseline|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13840|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13841|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13754|NCT02446613|B1|Baseline|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13755|NCT02446613|P2|Participant Flow|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 nanograms (ng), i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post NAC.
13756|NCT02446613|P1|Participant Flow|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to nasal allergen challenge (NAC) at Visit 2 to investigate the long term effect of matching placebo, intranasal (i.n.), administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 hours (h) post NAC.
13757|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13758|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13759|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym. were recorded up to 6 h post-NAC.
13760|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13761|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13762|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13763|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym. were recorded up to 6 h post-NAC.
13764|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13765|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym were recorded up to 6 h post-NAC.
13766|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
13767|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
13819|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13768|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
13769|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
13770|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13771|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym. were recorded up to 6 h post-NAC.
13772|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
35490|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
13773|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13774|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13775|NCT02446613|E2|Reported Event|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13776|NCT02446613|E1|Reported Event|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
13777|NCT02446496|B1|Baseline|Treatment A-cefadroxil 1 gm + Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gram [gm] film coated [F.C.] tablet) or treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 ante meridiem (am) and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13778|NCT02446496|P1|Participant Flow|Treatment A-cefadroxil 1 gm + Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gram [gm] film coated [F.C.] tablet) or treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 ante meridiem (am) and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13779|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13780|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13781|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13782|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13783|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13820|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13821|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13784|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13785|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13786|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13842|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13843|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13844|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13787|NCT02446496|E2|Reported Event|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13788|NCT02446496|E1|Reported Event|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
13789|NCT02446483|B1|Baseline|Treatment A-rabeprazole 20 mg + Treatment B-rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 20 mg enteric coated tablet) or treatment B (rabeprazole 20 mg gastro-resistant tablet), given with 240 mL water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
13790|NCT02446483|P2|Participant Flow|Treatment B-rabeprazole 20mg,Then Treatment A-rabeprazole 20mg|Participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) given with 240 mL water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. After a washout period of 7 days, participants then received one tablet of treatment A (rabeprazole 20 mg enteric coated tablet) given with 240 mL water. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period.
13791|NCT02446483|P1|Participant Flow|Treatment A-rabeprazole 20mg,Then Treatment B-rabeprazole 20mg|Participants received one tablet of treatment A (rabeprazole 20 milligram [mg] enteric coated tablet) given with 240 milliliter (mL) water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. After a washout period of 7 days, participants then received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) given with 240 mL water. Participants were admitted the night before study drug administration, supervised for at least 10 hours (h) of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 ante meridiem (am) and 10:51 am on Day 1 of each study period.
13792|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
13793|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
13794|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
13822|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13823|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13824|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
21122|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
13795|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
13796|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
35491|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
13797|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
13798|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
13799|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
13800|NCT02446483|E2|Reported Event|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
13801|NCT02446483|E1|Reported Event|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
13802|NCT02446171|B5|Baseline|Total|Total of all reporting groups
13803|NCT02446171|B4|Baseline|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
13804|NCT02446171|B3|Baseline|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
13805|NCT02446171|B2|Baseline|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
13806|NCT02446171|B1|Baseline|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
13807|NCT02446171|P4|Participant Flow|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
13808|NCT02446171|P3|Participant Flow|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
13809|NCT02446171|P2|Participant Flow|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
13810|NCT02446171|P1|Participant Flow|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
13811|NCT02446171|O2|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13812|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13813|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13814|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13815|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13816|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13817|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13818|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13828|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13829|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13830|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13831|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13832|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13833|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13834|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13835|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13836|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13837|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13838|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13847|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13848|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13849|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13850|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13851|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13852|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13853|NCT02446171|O1|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13854|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13855|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13856|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13857|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13858|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13859|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13860|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13861|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13862|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13863|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13864|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13865|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13866|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13867|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13868|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13869|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13870|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13871|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13872|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13873|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13874|NCT02446171|E4|Reported Event|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
13875|NCT02446171|E3|Reported Event|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
13876|NCT02446171|E2|Reported Event|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
13877|NCT02446171|E1|Reported Event|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
13878|NCT02446015|B3|Baseline|Total|Total of all reporting groups
13879|NCT02446015|B2|Baseline|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
13880|NCT02446015|B1|Baseline|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
13881|NCT02446015|P2|Participant Flow|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days
13882|NCT02446015|P1|Participant Flow|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days
13883|NCT02446015|O2|Outcome|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
13884|NCT02446015|O1|Outcome|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
13885|NCT02446015|O2|Outcome|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
13886|NCT02446015|O1|Outcome|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
13887|NCT02446015|O2|Outcome|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
13888|NCT02446015|O1|Outcome|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
13889|NCT02446015|E3|Reported Event|Systane Ultra PRN|All subjects treated with SYSTANE® ULTRA lubricant eye drops PRN
13890|NCT02446015|E2|Reported Event|Systane Ultra QID|All subjects treated with SYSTANE® ULTRA lubricant eye drops QID
13891|NCT02446015|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
13892|NCT02445755|B1|Baseline|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
13893|NCT02445755|P1|Participant Flow|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
13894|NCT02445755|O4|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.
13895|NCT02445755|O3|Outcome|JM103 TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device
13896|NCT02445755|O2|Outcome|BiliCare TcB With Infection Control Tip|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the BiliCare TcB device with infection control tip.
13897|NCT02445755|O1|Outcome|BiliCare TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the BiliCare TcB device
14054|NCT02442804|E2|Reported Event|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
13898|NCT02445755|E1|Reported Event|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
13899|NCT02445573|B3|Baseline|Total|Total of all reporting groups
13900|NCT02445573|B2|Baseline|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
13901|NCT02445573|B1|Baseline|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
13902|NCT02445573|P2|Participant Flow|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
13903|NCT02445573|P1|Participant Flow|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 milliampere (mA) for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
13904|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
13905|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
13918|NCT02445287|B1|Baseline|Predicate & Invest.- Cadavers 2D & 3D|Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph. Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT.
13919|NCT02445287|P2|Participant Flow|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only.
13906|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
13907|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
13908|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
13931|NCT02445287|E1|Reported Event|Predicate & Invest.- Cadavers 2D|Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph.
13909|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
13910|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
13911|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
13912|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
13913|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
13914|NCT02445573|E2|Reported Event|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
13915|NCT02445573|E1|Reported Event|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
13916|NCT02445287|B3|Baseline|Total|Total of all reporting groups
13917|NCT02445287|B2|Baseline|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only.
13966|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13920|NCT02445287|P1|Participant Flow|Predicate & Invest.- Cadavers 2D & 3D|Cadaveric specimens will be imaged with 2D devices CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT).
13921|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - SND|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
13932|NCT02445196|B3|Baseline|Total|Total of all reporting groups
13933|NCT02445196|B2|Baseline|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
14055|NCT02442804|E1|Reported Event|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
13922|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
13923|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - FDK|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
13924|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
13925|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - High Res|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
13926|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
13927|NCT02445287|O2|Outcome|Investigational - Cadavers 2D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
13941|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
14038|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
13928|NCT02445287|O1|Outcome|Predicate - Cadavers 2D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.
All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
13929|NCT02445287|E3|Reported Event|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only.
13930|NCT02445287|E2|Reported Event|Reference & Invest. - Cadavers 3D|Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT.
13934|NCT02445196|B1|Baseline|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13935|NCT02445196|P2|Participant Flow|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13936|NCT02445196|P1|Participant Flow|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13937|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13938|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13939|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13940|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13942|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13943|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13944|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13945|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
14052|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
13946|NCT02445196|E2|Reported Event|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.
Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13947|NCT02445196|E1|Reported Event|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
Smartphone: All participants must have a smartphone, either apple or android."
13948|NCT02444715|B3|Baseline|Total|Total of all reporting groups
13949|NCT02444715|B2|Baseline|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13950|NCT02444715|B1|Baseline|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13951|NCT02444715|P2|Participant Flow|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13952|NCT02444715|P1|Participant Flow|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13953|NCT02444715|O1|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13954|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13955|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13956|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13957|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13958|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13959|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13960|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13961|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13962|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13963|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13964|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13965|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
21123|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
13967|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13968|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13969|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13970|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13971|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13972|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13973|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13974|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
14056|NCT02442700|B3|Baseline|Total|Total of all reporting groups
13975|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13976|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13977|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13978|NCT02444715|E2|Reported Event|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
13979|NCT02444715|E1|Reported Event|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
13980|NCT02444533|B3|Baseline|Total|Total of all reporting groups
13981|NCT02444533|B2|Baseline|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
13982|NCT02444533|B1|Baseline|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
13983|NCT02444533|P2|Participant Flow|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
13984|NCT02444533|P1|Participant Flow|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
13985|NCT02444533|O2|Outcome|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
13986|NCT02444533|O1|Outcome|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
13987|NCT02444533|O2|Outcome|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
13988|NCT02444533|O1|Outcome|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
13989|NCT02444533|O2|Outcome|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
13990|NCT02444533|O1|Outcome|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
13991|NCT02444533|O2|Outcome|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
13992|NCT02444533|O1|Outcome|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
13993|NCT02444533|O2|Outcome|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
13994|NCT02444533|O1|Outcome|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
13995|NCT02444533|E2|Reported Event|No Treatment|Patient will not be given any medications in the tonsillar fossae after tonsillectomy
13996|NCT02444533|E1|Reported Event|Liposomal Bupivacaine|"Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy.
Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy."
13997|NCT02444182|B3|Baseline|Total|Total of all reporting groups
13998|NCT02444182|B2|Baseline|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)
Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
13999|NCT02444182|B1|Baseline|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG
Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
21124|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
14000|NCT02444182|P2|Participant Flow|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)
Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
14001|NCT02444182|P1|Participant Flow|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG
Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
14002|NCT02444182|O2|Outcome|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)
Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
14003|NCT02444182|O1|Outcome|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG
Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
14004|NCT02444182|O2|Outcome|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)
Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
14005|NCT02444182|O1|Outcome|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG
Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
14006|NCT02444182|E2|Reported Event|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)
Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
14007|NCT02444182|E1|Reported Event|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG
Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
14008|NCT02443792|B3|Baseline|Total|Total of all reporting groups
14009|NCT02443792|B2|Baseline|Open Surgical|"Open surgical circumcision under local anesthetic with suturing
Open Surgical: As above"
14010|NCT02443792|B1|Baseline|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Unicirc with tissue adhesive: As above"
14011|NCT02443792|P2|Participant Flow|Open Surgical|"Open surgical circumcision under local anesthetic with suturing
Open Surgical: As above"
14012|NCT02443792|P1|Participant Flow|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Unicirc with tissue adhesive: As above"
14013|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing
Open Surgical: As above"
14014|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Unicirc with tissue adhesive: As above"
14015|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing
Open Surgical: As above"
14016|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Unicirc with tissue adhesive: As above"
14017|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing
Open Surgical: As above"
14018|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Unicirc with tissue adhesive: As above"
14019|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing
Open Surgical: As above"
14020|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Unicirc with tissue adhesive: As above"
14021|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing
Open Surgical: As above"
14022|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Unicirc with tissue adhesive: As above"
14023|NCT02443792|E2|Reported Event|Open Surgical|"Open surgical circumcision under local anesthetic with suturing
Open Surgical: As above"
14024|NCT02443792|E1|Reported Event|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Unicirc with tissue adhesive: As above"
14025|NCT02442804|B3|Baseline|Total|Total of all reporting groups
14026|NCT02442804|B2|Baseline|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14027|NCT02442804|B1|Baseline|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14028|NCT02442804|P2|Participant Flow|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14029|NCT02442804|P1|Participant Flow|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14030|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14031|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14032|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14033|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14034|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14035|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14036|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14037|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14039|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14040|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14041|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14042|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14043|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14044|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14045|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14046|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14047|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14048|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14049|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14050|NCT02442804|O2|Outcome|Stroke - Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
14051|NCT02442804|O1|Outcome|Stroke - POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
14057|NCT02442700|B2|Baseline|Treatment B, A|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
14058|NCT02442700|B1|Baseline|Treatment A, B|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
14059|NCT02442700|P2|Participant Flow|Treatment B, A|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
14060|NCT02442700|P1|Participant Flow|Treatment A, B|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
14061|NCT02442700|O2|Outcome|Treatment B|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
14062|NCT02442700|O1|Outcome|Treatment A|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
14063|NCT02442700|O2|Outcome|Treatment B|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
14064|NCT02442700|O1|Outcome|Treatment A|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
14065|NCT02442700|E2|Reported Event|Treatment B|Treatment B = administration placebo for 12 weeks
14066|NCT02442700|E1|Reported Event|Treatment A|Treatment A = administration pitavastatin for 12 weeks
14067|NCT02442349|B1|Baseline|AZD9291 80mg|Daily single dose of AZD9291 80mg
14068|NCT02442349|P1|Participant Flow|AZD9291 80mg|Daily single dose of AZD9291 80mg
14069|NCT02442349|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
14070|NCT02442349|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
14071|NCT02442349|E1|Reported Event|AZD9291 80mg|Daily single dose of AZD9291 80mg
14072|NCT02442310|B1|Baseline|Healthy Volunteers|"Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:
Deferiprone delayed release tablets under fed conditions.
Deferiprone delayed release tablets under fasting conditions.
Deferiprone delayed release tablets administered as half-tablets, under fed conditions.
Deferiprone oral solution under fasting conditions"
14073|NCT02442310|P1|Participant Flow|Healthy Volunteers|"Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:
Deferiprone delayed release tablets under fed conditions.
Deferiprone delayed release tablets under fasting conditions.
Deferiprone delayed release tablets administered as half-tablets, under fed conditions.
Deferiprone oral solution under fasting conditions"
14074|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast
Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
14075|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14076|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14077|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14078|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast
Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
14105|NCT02442271|O2|Outcome|Fibrosis Stage F4|Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
21125|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
14079|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14080|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14081|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14082|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast
Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
14083|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14084|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14085|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14086|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast
Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
14087|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
35492|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
14088|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14089|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14090|NCT02442310|E4|Reported Event|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast
Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
14091|NCT02442310|E3|Reported Event|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14092|NCT02442310|E2|Reported Event|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14093|NCT02442310|E1|Reported Event|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
14094|NCT02442284|B1|Baseline|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
14095|NCT02442284|P1|Participant Flow|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
14096|NCT02442284|O1|Outcome|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
14097|NCT02442284|O1|Outcome|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
14098|NCT02442284|O1|Outcome|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
14099|NCT02442284|O1|Outcome|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
14100|NCT02442284|E1|Reported Event|3-DAA ± RBV for 12 or 24 Weeks|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
14101|NCT02442271|B1|Baseline|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
14102|NCT02442271|P1|Participant Flow|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
14103|NCT02442271|O2|Outcome|Fibrosis Stage F4|Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
14104|NCT02442271|O1|Outcome|Fibrosis Stage F3|Participants with baseline fibrosis stage F3 (without cirrhosis).
14106|NCT02442271|O1|Outcome|Fibrosis Stage F3|Participants with baseline fibrosis stage F3 (without cirrhosis).
14107|NCT02442271|O2|Outcome|Fibrosis Stage F4|Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
14108|NCT02442271|O1|Outcome|Fibrosis Stage F3|Participants with baseline fibrosis stage F3 (without cirrhosis).
14109|NCT02442271|O4|Outcome|Interferon (IFN)-Eligible, Treatment-Experienced|Participants who had received prior antiviral treatment for HCV infection and were eligible for treatment with IFN at screening.
14110|NCT02442271|O3|Outcome|Interferon (IFN)-Ineligible, Treatment-Experienced|Participants who had received prior antiviral treatment for HCV infection and were ineligible for treatment with IFN at screening.
14111|NCT02442271|O2|Outcome|Interferon (IFN)-Eligible, Treatment-Naive|Participants who had never received any antiviral treatment for HCV infection and were eligible for treatment with IFN at screening.
14112|NCT02442271|O1|Outcome|Interferon (IFN)-Ineligible, Treatment-Naive|Participants who had never received any antiviral treatment for HCV infection and were ineligible for treatment with IFN at screening.
14113|NCT02442271|O8|Outcome|Other|Participants who received IFN treatment, including IFN or pegIFN monotherapy, IFN/RBV, or pegIFN/RBV experienced subjects. Includes subjects who do not have adequate documentation of response.
14114|NCT02442271|O7|Outcome|IFN Interolerant|Participants who did not meet any of the other definitions of treatment failure and discontinued IFN/RBV or pegIFN/RBV therapy due to IFN intolerability
14115|NCT02442271|O6|Outcome|Pegylated Interferon (PegIFN)/RBV Breakthrough|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least one documented result of HCV RNA undetectable during a prior IFN/RBV or pegIFN/RBV treatment course
14116|NCT02442271|O5|Outcome|Pegylated Interferon (PegIFN)/RBV Relapser|Participants who had received prior treatment with pegIFN-based therapy for HCV infection who achieved HCV undetectable at end of a prior IFN/RBV or pegIFN/RBV treatment course but HCV RNA was detectable following cessation of therapy
14593|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
14117|NCT02442271|O4|Outcome|Pegylated Interferon (PegIFN)/RBV Non-Responders|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course.
14118|NCT02442271|O3|Outcome|Pegylated Interferon (PegIFN)//RBV Partial Responders|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course but failed to achieve HCV RNA undetectable at the end of treatment
14119|NCT02442271|O2|Outcome|Pegylated Interferon (PegIFN)/RBV Null Responders|Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course
14120|NCT02442271|O1|Outcome|Treatment-Naive|Participants who had never received any antiviral treatment for HCV infection.
14121|NCT02442271|O2|Outcome|Fibrosis Stage F4|Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
14122|NCT02442271|O1|Outcome|Fibrosis Stage F3|Participants with baseline fibrosis stage F3 (without cirrhosis).
14123|NCT02442271|O1|Outcome|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
14124|NCT02442271|E1|Reported Event|3-DAA ± RBV|3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
14125|NCT02441218|B3|Baseline|Total|Total of all reporting groups
14126|NCT02441218|B2|Baseline|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14127|NCT02441218|B1|Baseline|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14128|NCT02441218|P2|Participant Flow|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14129|NCT02441218|P1|Participant Flow|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14130|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14131|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14132|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14133|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14134|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14135|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14136|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14137|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14138|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14139|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
21126|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
14140|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14141|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14142|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14143|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14144|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14145|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14146|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14147|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14148|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14149|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14150|NCT02441218|E2|Reported Event|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14151|NCT02441218|E1|Reported Event|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
14152|NCT02441179|B3|Baseline|Total|Total of all reporting groups
14153|NCT02441179|B2|Baseline|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
14154|NCT02441179|B1|Baseline|Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
14155|NCT02441179|P2|Participant Flow|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
14156|NCT02441179|P1|Participant Flow|Acute Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
14157|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
14158|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
14159|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
14573|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
14160|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
14161|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
14162|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
14594|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
35493|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
14163|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
14164|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
14165|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
14166|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
14167|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
14168|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
14169|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
14204|NCT02439879|B1|Baseline|Alpha Lipoic Acid Treatment|"After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
Alpha lipoic acid: Alpha lipoic acid 1800 mg PO divided in 3 doses for 4 weeks . If total symptoms score decreased >3 points patients received alpha lipoic acid 600 mg PO each day or no treatment for 16 weeks."
14574|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
14575|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
14170|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
14171|NCT02441179|E2|Reported Event|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
14210|NCT02439879|E1|Reported Event|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
14211|NCT02439164|B3|Baseline|Total|Total of all reporting groups
14212|NCT02439164|B2|Baseline|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14172|NCT02441179|E1|Reported Event|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
14173|NCT02441114|B1|Baseline|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days."
14174|NCT02441114|P1|Participant Flow|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days."
14175|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days."
14176|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days."
14177|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days."
14178|NCT02441114|E1|Reported Event|HCP0910 and HGP1011|"Single Inhalation of HCP0910 and HGP1011 (Open-label, Single-arm, Single dosing, Dose-escalation)
HCP0910 and HGP1011: Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))"
14179|NCT02440659|B3|Baseline|Total|Total of all reporting groups
14180|NCT02440659|B2|Baseline|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
14181|NCT02440659|B1|Baseline|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
14182|NCT02440659|P2|Participant Flow|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
14183|NCT02440659|P1|Participant Flow|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
14184|NCT02440659|O2|Outcome|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
14185|NCT02440659|O1|Outcome|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
14186|NCT02440659|E2|Reported Event|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
14187|NCT02440659|E1|Reported Event|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
14188|NCT02440633|B1|Baseline|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071
14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
14189|NCT02440633|P1|Participant Flow|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071
14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
14190|NCT02440633|O1|Outcome|Plasma|
14191|NCT02440633|O2|Outcome|Whole Blood|
14192|NCT02440633|O1|Outcome|Plasma|
14193|NCT02440633|O3|Outcome|Total|
14194|NCT02440633|O2|Outcome|Urine|
14195|NCT02440633|O1|Outcome|Feces|
14196|NCT02440633|E1|Reported Event|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071
14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
14197|NCT02440308|B1|Baseline|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
14198|NCT02440308|P1|Participant Flow|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
14199|NCT02440308|O1|Outcome|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
14200|NCT02440308|O1|Outcome|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
14201|NCT02440308|E1|Reported Event|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
14202|NCT02439879|B3|Baseline|Total|Total of all reporting groups
14203|NCT02439879|B2|Baseline|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
14205|NCT02439879|P2|Participant Flow|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
14206|NCT02439879|P1|Participant Flow|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
14207|NCT02439879|O2|Outcome|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
14208|NCT02439879|O1|Outcome|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
14209|NCT02439879|E2|Reported Event|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
14595|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
14213|NCT02439164|B1|Baseline|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14214|NCT02439164|P2|Participant Flow|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14215|NCT02439164|P1|Participant Flow|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14216|NCT02439164|O1|Outcome|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14217|NCT02439164|O2|Outcome|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14218|NCT02439164|O1|Outcome|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14219|NCT02439164|O2|Outcome|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14220|NCT02439164|O1|Outcome|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14221|NCT02439164|O2|Outcome|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14222|NCT02439164|O1|Outcome|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14223|NCT02439164|O2|Outcome|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14224|NCT02439164|O1|Outcome|Glioma Group|"Patients in this group will be administered sedative midazolam titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14225|NCT02439164|E2|Reported Event|Non-neurosurgical Group|"patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14226|NCT02439164|E1|Reported Event|Glioma Group|"Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal"
14227|NCT02439138|B1|Baseline|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.
-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
GS-1101"
14322|NCT02437305|O2|Outcome|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.
ABCDEs of Melanoma: Conventional melanoma educational intervention."
14228|NCT02439138|P1|Participant Flow|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.
-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
GS-1101"
14229|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.
-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
GS-1101"
14230|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.
-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
GS-1101"
14231|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.
-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
GS-1101"
14232|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.
-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
GS-1101"
14233|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.
-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
GS-1101"
14234|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.
-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
GS-1101"
14235|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.
-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
GS-1101"
14236|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.
-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
GS-1101"
14237|NCT02439138|E1|Reported Event|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.
-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
GS-1101"
14238|NCT02438540|B3|Baseline|Total|Total of all reporting groups
14239|NCT02438540|B2|Baseline|Metformin & Placebo|"Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and placebo ( for acupuncture treatment including electro body acupuncture and Auricular acupuncture), needling not in right acupoints (for those points that were located in the abdomen, needles were inserted 0.3 cm laterally from the real location and the needling was maximally superficial. Those points that were located on other parts of the body, needles were inserted 0.5 cm up and 0.5 cm laterally from the real location and needling was superficial as well. Electric lines were connected with some of the needles same way they were connected in another case group. EA machine was switched off during 30 minutes of therapeutic time. Ear acupuncture was used on the same location as in the case group however we just used sticky layers without seeds), for 30 minutes, 10 times, every other day, for 3 weeks.
metformin Placebo (for acupuncture including electro"
14240|NCT02438540|B1|Baseline|Metformin & Acupuncture|"Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14241|NCT02438540|P2|Participant Flow|Metformin & Placebo|Metformin 500 mg (one/two/three times per day) to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and electro acupuncture (EA) machine was switched off during 30 minutes of therapeutic time. And ear acupuncture was just used sticky layers without seeds. All placebo treatments used for 30 minutes, 10 times, every other day, for 3 weeks.
14242|NCT02438540|P1|Participant Flow|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14243|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14244|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14576|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
14245|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14246|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14247|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14248|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14349|NCT02436577|P5|Participant Flow|BAC Sequence|Subjects were administered a single dose of Treatment B, A and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14249|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14250|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14251|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14252|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14253|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14254|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14255|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14256|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14257|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14258|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14259|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14260|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14435|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14261|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14262|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14263|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14264|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14265|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14266|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14267|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14268|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14269|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14270|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14271|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14272|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14273|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14274|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14275|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo EA and auricular acupuncture"
14276|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14434|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14277|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14278|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14279|NCT02438540|E2|Reported Event|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
Placebo acupuncture including placebo EA and auricular acupuncture"
14350|NCT02436577|P4|Participant Flow|ACB Sequence|Subjects were administered a single dose of Treatment A, C and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14596|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
14280|NCT02438540|E1|Reported Event|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture"
14281|NCT02438137|B3|Baseline|Total|Total of all reporting groups
14282|NCT02438137|B2|Baseline|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.
Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
14283|NCT02438137|B1|Baseline|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.
Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
14284|NCT02438137|P2|Participant Flow|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.
Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
14285|NCT02438137|P1|Participant Flow|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.
Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
14286|NCT02438137|O2|Outcome|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Subjects randomized to placebo will be instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.
Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Subjects were instructed to take the placebo with food, in the morning and at dinnertime. If subjects missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
14287|NCT02438137|O1|Outcome|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day, though slower dose escalations were possible to increase tolerability, if necessary. Subjects randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.
Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance was reconciled at follow-up visits, and recorded in accountability logs. Subjects were instructed to take medication with food, (morning and at dinnertime). If subjects missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
14343|NCT02436577|B5|Baseline|BAC Sequence|Subjects were administered a single dose of Treatment B, A and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14288|NCT02438137|O2|Outcome|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo will be instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.
Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
14300|NCT02437513|B1|Baseline|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.
Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.
NewBreez: Intralaryngeal prosthesis to protect the airways"
14384|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14289|NCT02438137|O1|Outcome|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.
Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
14290|NCT02438137|E2|Reported Event|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.
Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
14291|NCT02438137|E1|Reported Event|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.
Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
14292|NCT02437903|B1|Baseline|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.
JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
14293|NCT02437903|P1|Participant Flow|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.
JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
14294|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.
JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
14295|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.
JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
14296|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.
JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
14297|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.
JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
14298|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.
JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12"
14344|NCT02436577|B4|Baseline|ACB Sequence|Subjects were administered a single dose of Treatment A, C and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14299|NCT02437903|E1|Reported Event|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.
JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
14348|NCT02436577|P6|Participant Flow|CBA Sequence|Subjects were administered a single dose of Treatment C, B and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14301|NCT02437513|P1|Participant Flow|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.
Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.
NewBreez: Intralaryngeal prosthesis to protect the airways"
14302|NCT02437513|O1|Outcome|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.
Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.
NewBreez: Intralaryngeal prosthesis to protect the airways"
14303|NCT02437513|O1|Outcome|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.
Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.
NewBreez: Intralaryngeal prosthesis to protect the airways"
14304|NCT02437513|O1|Outcome|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.
Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.
NewBreez: Intralaryngeal prosthesis to protect the airways"
14305|NCT02437513|O1|Outcome|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.
Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.
NewBreez: Intralaryngeal prosthesis to protect the airways"
14306|NCT02437513|O1|Outcome|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.
Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.
NewBreez: Intralaryngeal prosthesis to protect the airways"
14307|NCT02437513|E1|Reported Event|NewBreez|"The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.
Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires.
NewBreez: Intralaryngeal prosthesis to protect the airways"
14308|NCT02437409|B1|Baseline|All Patients|Treated with pREset Thrombectomy Retriever
14309|NCT02437409|P1|Participant Flow|All Patients|Treated with pREset Thrombectomy Retriever
14310|NCT02437409|O1|Outcome|Occluded Vessels|100 patients harboured 109 vessel occlusions
14311|NCT02437409|O1|Outcome|Occluded Vessels|100 patients harboured 109 vessel occlusions
14312|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
14313|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
14314|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
14315|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
14316|NCT02437409|E1|Reported Event|All Patients|Treated with pREset Thrombectomy Retriever
14317|NCT02437305|B3|Baseline|Total|Total of all reporting groups
14318|NCT02437305|B2|Baseline|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.
ABCDEs of Melanoma: Conventional melanoma educational intervention."
14319|NCT02437305|B1|Baseline|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.
ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
14320|NCT02437305|P2|Participant Flow|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.
ABCDEs of Melanoma: Conventional melanoma educational intervention."
14321|NCT02437305|P1|Participant Flow|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.
ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
14323|NCT02437305|O1|Outcome|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.
ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
14324|NCT02437305|O2|Outcome|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.
ABCDEs of Melanoma: Conventional melanoma educational intervention."
14481|NCT02434939|B3|Baseline|Total|Total of all reporting groups
14597|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
14325|NCT02437305|O1|Outcome|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.
ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
14326|NCT02437305|E2|Reported Event|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.
ABCDEs of Melanoma: Conventional melanoma educational intervention."
14327|NCT02437305|E1|Reported Event|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.
ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
14328|NCT02436811|B4|Baseline|Total|Total of all reporting groups
14329|NCT02436811|B3|Baseline|Control|60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
14330|NCT02436811|B2|Baseline|Written Form Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
14331|NCT02436811|B1|Baseline|Standardized Oral Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
14332|NCT02436811|P3|Participant Flow|Control|women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
14333|NCT02436811|P2|Participant Flow|Written Form Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
14334|NCT02436811|P1|Participant Flow|Standardized Oral Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
14335|NCT02436811|O3|Outcome|Control|women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
14336|NCT02436811|O2|Outcome|Written Form Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
14337|NCT02436811|O1|Outcome|Standardized Oral Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
14338|NCT02436811|E3|Reported Event|Control|60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
14339|NCT02436811|E2|Reported Event|Written Form Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
14340|NCT02436811|E1|Reported Event|Standardized Oral Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
14341|NCT02436577|B7|Baseline|Total|Total of all reporting groups
14342|NCT02436577|B6|Baseline|CBA Sequence|Subjects were administered a single dose of Treatment C, B and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14345|NCT02436577|B3|Baseline|CAB Sequence|Subjects were administered a single dose of Treatment C, A and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14346|NCT02436577|B2|Baseline|BCA Sequence|Subjects were administered a single dose of Treatment B, C and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14347|NCT02436577|B1|Baseline|ABC Sequence|Subjects were administered a single dose of Treatment A, B and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14351|NCT02436577|P3|Participant Flow|CAB Sequence|Subjects were administered a single dose of Treatment C, A and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14352|NCT02436577|P2|Participant Flow|BCA Sequence|Subjects were administered a single dose of Treatment B, C and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14353|NCT02436577|P1|Participant Flow|ABC Sequence|Subjects were administered a single dose of Treatment A, B and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
14354|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14355|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14356|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14357|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14358|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14359|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14360|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14361|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14362|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14363|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14364|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14365|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14366|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14367|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14368|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14369|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14370|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14371|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14372|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14373|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14374|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14375|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14376|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14377|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14378|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14379|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14380|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14381|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14382|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14383|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
15588|NCT02431598|B1|Baseline|Eovistvs vs. Dotarem vs. Saline|
14385|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14386|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14387|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14388|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14389|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14390|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14391|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14392|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14393|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14394|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14395|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14396|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14397|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14398|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14399|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14400|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14401|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14402|NCT02436577|E3|Reported Event|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
14403|NCT02436577|E2|Reported Event|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
14404|NCT02436577|E1|Reported Event|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
14405|NCT02436330|B3|Baseline|Total|Total of all reporting groups
14406|NCT02436330|B2|Baseline|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
14407|NCT02436330|B1|Baseline|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
14433|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14408|NCT02436330|P2|Participant Flow|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period.
n = 24 (29%) enrolled within 6 cohorts during the study period from April 2011 to September 2013"
14409|NCT02436330|P1|Participant Flow|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period.
n = 60 (71%) enrolled within 6 cohorts over the study period from April 2011 to September 2013."
14410|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
14411|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
14412|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
14413|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
14414|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Intervention group subjects (exergaming combined with didactic nutrition teaching) with continued participation at 6 months completed this questionnaire regarding attitudes/perceptions towards participation.
14415|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14416|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14417|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14418|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14419|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14420|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14421|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14422|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14423|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14424|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14425|NCT02436330|O2|Outcome|Didactic Health Teaching|Subjects only receiving classroom structured nutrition/health education.
14426|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects attending exergaming/physical activity along with classroom structured nutrition/health education.
14427|NCT02436330|O2|Outcome|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
14428|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
14429|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14430|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14431|NCT02436330|O2|Outcome|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
14432|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
14436|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14437|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14438|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14439|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14440|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14441|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14442|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14443|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
35494|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
14444|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14445|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
14446|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
14447|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
14448|NCT02436330|E2|Reported Event|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
14449|NCT02436330|E1|Reported Event|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
14450|NCT02436304|B4|Baseline|Total|Total of all reporting groups
14451|NCT02436304|B3|Baseline|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
14452|NCT02436304|B2|Baseline|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
14453|NCT02436304|B1|Baseline|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
14454|NCT02436304|P3|Participant Flow|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
14455|NCT02436304|P2|Participant Flow|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
14456|NCT02436304|P1|Participant Flow|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
14457|NCT02436304|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
14458|NCT02436304|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
14459|NCT02436304|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
14460|NCT02436304|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
14461|NCT02436304|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
14462|NCT02436304|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
14463|NCT02436304|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
14464|NCT02436304|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
14465|NCT02436304|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion
14466|NCT02436304|E4|Reported Event|Tubes Only|All participants who underwent bilateral myringotomy and tympanostomy tube insertion only
14467|NCT02436304|E3|Reported Event|EXE844 3 Days|All participants exposed to EXE844 Sterile Otic Suspension, 0.3%, for 3 days after Tympanostomy Tube Insertion
14468|NCT02436304|E2|Reported Event|EXE844 7 Days|All participants exposed to EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion
14469|NCT02436304|E1|Reported Event|Pretreatment|All who consented to participate in the study prior to randomization
14470|NCT02436031|B1|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.
14471|NCT02436031|P2|Participant Flow|Placebo First, Desipramine Second|Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.
14569|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
14570|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
14472|NCT02436031|P1|Participant Flow|Desipramine First, Placebo Second|Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night.
14473|NCT02436031|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
14474|NCT02436031|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
14475|NCT02436031|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
14476|NCT02436031|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
14477|NCT02436031|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
14478|NCT02436031|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
14479|NCT02436031|E2|Reported Event|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
14480|NCT02436031|E1|Reported Event|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
14482|NCT02434939|B2|Baseline|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.
Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14483|NCT02434939|B1|Baseline|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.
Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14484|NCT02434939|P2|Participant Flow|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.
Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14485|NCT02434939|P1|Participant Flow|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.
Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14486|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.
Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14487|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.
Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14488|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes . Maximum of 2 doses to be given during the study period that will last 2 hours.
Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14489|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.
Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14490|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.
Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14491|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.
Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14492|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.
Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14493|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.
Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14494|NCT02434939|E2|Reported Event|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.
Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14571|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
14495|NCT02434939|E1|Reported Event|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.
Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
14496|NCT02435966|B4|Baseline|Total|Total of all reporting groups
14497|NCT02435966|B3|Baseline|Untreated Control|Natural history of the condition
14498|NCT02435966|B2|Baseline|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval
Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
14499|NCT02435966|B1|Baseline|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval
Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
14500|NCT02435966|P3|Participant Flow|Untreated Control|Natural history of the condition
14588|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
14589|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
14501|NCT02435966|P2|Participant Flow|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval
Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
14502|NCT02435966|P1|Participant Flow|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval
Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
14503|NCT02435966|O3|Outcome|Untreated Control|Natural history of the condition
14504|NCT02435966|O2|Outcome|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval
Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
14505|NCT02435966|O1|Outcome|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval
Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
14506|NCT02435966|E3|Reported Event|Untreated Control|Natural history of the condition
14507|NCT02435966|E2|Reported Event|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval
Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
14508|NCT02435966|E1|Reported Event|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval
Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
14509|NCT02435836|B1|Baseline|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14510|NCT02435836|P1|Participant Flow|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14511|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14512|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14513|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14514|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14515|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14516|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14517|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14518|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14519|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14520|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14521|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14522|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14523|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14524|NCT02435836|E1|Reported Event|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
14525|NCT02434523|B3|Baseline|Total|Total of all reporting groups
14526|NCT02434523|B2|Baseline|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14527|NCT02434523|B1|Baseline|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14528|NCT02434523|P2|Participant Flow|Placebo|Subjects in this arm will receive pills composed only of Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14529|NCT02434523|P1|Participant Flow|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14530|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14531|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14532|NCT02434523|O2|Outcome|Placebo|"Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Placebo: Placebo pill"
14533|NCT02434523|O1|Outcome|Amitriptyline|"Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)
Amitriptyline"
14534|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14535|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14536|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14537|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14538|NCT02434523|E2|Reported Event|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14572|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
21127|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
14539|NCT02434523|E1|Reported Event|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
14540|NCT02434146|B1|Baseline|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14541|NCT02434146|P1|Participant Flow|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14590|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
14591|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
14542|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14543|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14544|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14545|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14546|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14547|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14548|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14549|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14550|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14551|NCT02434146|E1|Reported Event|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Topical Phenylephrine Solution: Given topically via spray"
14552|NCT02433834|B1|Baseline|Overall Study|All patients randomized
14553|NCT02433834|P1|Participant Flow|Overall Study|All patients randomized
14554|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
14555|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
14556|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
14557|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
14558|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
14559|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
14560|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
14561|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
14562|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
14563|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
14564|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
14565|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
14566|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
14567|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
14568|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
14577|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
14578|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
14579|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
14580|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
14581|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
14582|NCT02433834|O7|Outcome|SAL 50 µg|salmeterol 50 µg
14583|NCT02433834|O6|Outcome|Placebo MDI|Placebo MDI.
14584|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
14585|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
14586|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
14587|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
35495|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
14598|NCT02433834|O5|Outcome|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
14599|NCT02433834|O4|Outcome|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
14600|NCT02433834|O3|Outcome|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
14601|NCT02433834|O2|Outcome|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
14602|NCT02433834|O1|Outcome|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
14603|NCT02433834|E7|Reported Event|SAL 50 µg|salmeterol 50 µg
14604|NCT02433834|E6|Reported Event|Placebo MDI|Placebo MDI.
14605|NCT02433834|E5|Reported Event|GP MDI 1.9 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 1.9 µg
14606|NCT02433834|E4|Reported Event|GP MDI 3.6 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 3.6 µg
14607|NCT02433834|E3|Reported Event|GP MDI 7.2 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 7.2 µg
14608|NCT02433834|E2|Reported Event|GP MDI 14.4 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 14.4 µg
14609|NCT02433834|E1|Reported Event|GP MDI 28.8 µg|Glycopyrronium Metered Dose Inhaler (GP MDI) 28.8 µg
14610|NCT02433366|B3|Baseline|Total|Total of all reporting groups
14611|NCT02433366|B2|Baseline|Patients|AF patients on treatment with Pradaxa®.
14612|NCT02433366|B1|Baseline|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
14613|NCT02433366|P2|Participant Flow|Patients|AF patients on treatment with Pradaxa®.
14614|NCT02433366|P1|Participant Flow|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
14615|NCT02433366|O2|Outcome|Patients|AF patients on treatment with Pradaxa®.
14616|NCT02433366|O1|Outcome|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
14617|NCT02433366|O2|Outcome|Patients|AF patients on treatment with Pradaxa®.
14618|NCT02433366|O1|Outcome|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
14619|NCT02433366|E2|Reported Event|Patients|AF patients on treatment with Pradaxa®.
14620|NCT02433366|E1|Reported Event|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
14621|NCT02433340|B5|Baseline|Total|Total of all reporting groups
14622|NCT02433340|B4|Baseline|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14623|NCT02433340|B3|Baseline|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14624|NCT02433340|B2|Baseline|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14625|NCT02433340|B1|Baseline|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14626|NCT02433340|P4|Participant Flow|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14627|NCT02433340|P3|Participant Flow|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14628|NCT02433340|P2|Participant Flow|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14629|NCT02433340|P1|Participant Flow|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind Adalimumab (ADA) 40 mg every other week (EOW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14630|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14631|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14632|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14633|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14634|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14635|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14636|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14637|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14638|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14639|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14640|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14641|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14642|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14643|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14644|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14645|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14646|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14647|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14648|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14649|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14650|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14651|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14652|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14653|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14654|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14655|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14656|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14657|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14658|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14659|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14660|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14661|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14662|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14663|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14664|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14665|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14666|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14667|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14668|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14669|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14670|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14671|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14672|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14673|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14674|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14675|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14676|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14677|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14678|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14679|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14680|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14681|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14682|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14683|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14684|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14685|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14686|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14687|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14688|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
21128|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
14689|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14690|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14691|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14692|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14693|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14694|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14695|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14696|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14697|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14698|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14699|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14700|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14701|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14702|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14703|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14704|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14705|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14706|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14707|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14708|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14709|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14710|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14711|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14712|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14713|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14714|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14715|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14716|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14717|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14718|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14719|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14720|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14721|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14722|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14723|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14724|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14725|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14726|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14727|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14728|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14729|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14730|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14731|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14732|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14733|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14734|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14735|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14736|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14737|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14738|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14739|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14740|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14741|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14742|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14743|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14744|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14745|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14746|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14747|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14748|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14749|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14750|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14751|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14752|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14753|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14754|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14755|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14756|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14757|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14758|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14759|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14760|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14761|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14762|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14763|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14764|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14765|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14766|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14767|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14768|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14769|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14770|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14771|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14772|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14773|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14774|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14775|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14776|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14777|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14778|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14779|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14780|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14781|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14782|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14783|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14784|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14785|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14786|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14787|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14788|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14789|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14790|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14791|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
21129|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
14792|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14793|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14794|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14795|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14796|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14797|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14798|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14799|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14800|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14801|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14802|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14803|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14804|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14805|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14806|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14807|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14808|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14809|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14810|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14811|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14812|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14813|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14814|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14815|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14816|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14817|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14818|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14819|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14820|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14821|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14822|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14823|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14824|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14825|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14826|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14827|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14828|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14829|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14830|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14831|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14832|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14833|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14834|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14835|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14836|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14837|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14838|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14839|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14840|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14841|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14842|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
21130|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
14843|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14844|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14845|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14846|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14847|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14848|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14849|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14850|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14851|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14852|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14853|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14854|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14855|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14856|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14857|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14858|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14859|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14860|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14861|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14862|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14863|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14864|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14865|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14866|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14867|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14868|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14869|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14870|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14871|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14872|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14873|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14874|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14875|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14876|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14877|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14878|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14879|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14880|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14881|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14882|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14883|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14884|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14885|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14886|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14887|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14888|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14889|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14890|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14891|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14892|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14893|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
21131|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
14894|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14895|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14896|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14897|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14898|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14899|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14900|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14901|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14902|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14903|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14904|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14905|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14906|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14907|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14908|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14909|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14910|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14911|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14912|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14913|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14914|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14915|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14916|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14917|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14918|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14919|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14920|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14921|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14922|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14923|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14924|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14925|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14926|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14927|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14928|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14929|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14930|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14931|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14932|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14933|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14934|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14935|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14936|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14937|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14938|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14939|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14940|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14941|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14942|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14943|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14944|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14945|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14946|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14947|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14948|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14949|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14950|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14951|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14952|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14953|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14954|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14955|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14956|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14957|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14958|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14959|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14960|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14961|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14962|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14963|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14964|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14965|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14966|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14967|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14968|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14969|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14970|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14971|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14972|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14973|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14974|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14975|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14976|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14977|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14978|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14979|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14980|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14981|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14982|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14983|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14984|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14985|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14986|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14987|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14988|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14989|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14990|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14991|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
14992|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14993|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14994|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14995|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
14996|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
21132|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
14997|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14998|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
14999|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15000|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15001|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15002|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15003|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15004|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15005|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15006|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15007|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15008|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15009|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15010|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15011|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15012|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15013|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15014|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15015|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15016|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15017|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15018|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15019|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15020|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15021|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15022|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15023|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15024|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15025|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15026|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15027|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15028|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15029|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15030|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15031|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15032|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15033|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15034|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15035|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15036|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15037|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15038|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15039|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15040|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15041|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15042|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15043|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15044|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15045|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15046|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15047|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
21133|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
15048|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15049|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15050|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15051|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15052|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15053|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15054|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15055|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15056|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15057|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15058|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15059|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15060|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15061|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15062|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15063|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15064|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15065|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15066|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15067|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15068|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15069|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15070|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15071|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15072|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15073|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15074|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15075|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15076|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15077|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15078|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15079|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15080|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15081|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15082|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15083|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15084|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15085|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15086|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15087|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15088|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15089|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15090|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15091|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15092|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15093|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15094|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15095|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15096|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15097|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15098|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
21134|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
15099|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15100|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15101|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15102|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15103|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15104|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15105|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15106|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15107|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15108|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15109|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15110|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15111|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15112|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15113|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15114|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15115|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15116|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15117|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15118|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15119|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15120|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15121|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15122|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15123|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15124|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15125|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15126|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15127|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15128|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15129|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15130|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15131|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15132|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15133|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15134|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15135|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15136|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15137|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15138|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15139|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15140|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15141|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15142|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15143|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15144|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15145|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15146|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15147|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15148|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15149|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15150|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15151|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15152|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15153|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15154|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15155|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15156|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15157|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15158|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15159|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15160|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15161|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15162|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15163|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15164|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15165|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15166|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15167|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15168|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15169|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15170|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15171|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15172|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15173|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15174|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15175|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15176|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15177|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15178|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15179|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15180|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15181|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15182|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15183|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15184|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15185|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15186|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15187|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15188|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15189|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15190|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15191|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15192|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15193|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15194|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15195|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15196|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15197|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15198|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15199|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15200|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15201|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
21135|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
15202|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15203|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15204|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15205|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15206|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15207|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15208|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15209|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15210|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15211|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15212|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15213|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15214|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15215|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15216|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15217|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15218|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15219|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15220|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15221|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15222|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15223|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15224|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15225|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15226|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15227|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15228|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15229|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15230|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15231|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15232|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15233|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15234|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15235|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15236|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15237|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15238|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15239|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15240|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15241|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15242|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15243|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15244|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15245|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15246|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15247|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15248|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15249|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15250|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15251|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15252|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
21136|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
15253|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15254|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15255|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15256|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15257|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15258|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15259|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15260|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15261|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15262|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15263|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15264|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15265|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15266|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15267|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15268|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15269|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15270|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15271|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15272|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15273|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15274|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15275|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15276|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15277|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15278|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15279|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15280|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15281|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15282|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15283|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15284|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15285|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15286|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15287|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15288|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15289|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15290|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15291|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15292|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15293|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15294|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15295|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15296|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15297|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15298|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15299|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15300|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15301|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15302|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15303|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
21137|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
15304|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15305|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15306|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15307|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15308|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15309|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15310|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15311|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15312|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15313|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15314|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15315|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15316|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15317|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15318|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15319|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15320|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15321|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15322|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15323|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15324|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15325|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15326|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15327|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15328|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15329|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15330|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15331|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15332|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15333|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15334|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15335|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15336|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15337|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15338|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15339|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15340|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15341|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15342|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15343|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15344|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15345|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15346|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15347|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15348|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15349|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15350|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15351|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15352|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15353|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15354|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15355|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15356|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15357|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15358|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15359|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15360|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15361|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15362|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15363|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15364|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15365|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15366|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15367|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15368|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15369|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15370|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15371|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15372|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15373|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15374|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15375|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15376|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15377|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15378|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15379|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15380|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15381|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15382|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15383|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15384|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15385|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15386|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15387|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15388|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15389|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15390|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15391|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15392|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15393|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15394|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15395|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15396|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15397|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15398|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15399|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15400|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15401|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15402|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15403|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15404|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15405|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15406|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
21138|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
15407|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15408|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15409|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15410|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15411|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15412|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15413|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15414|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15415|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15416|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15417|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15418|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15419|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15420|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15421|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15422|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15423|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15424|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15425|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15426|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15427|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15428|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15429|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15430|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15431|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15432|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15433|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15434|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15435|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15436|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15437|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15438|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15439|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15440|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15441|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15442|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15443|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15444|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15445|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15446|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15447|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15448|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15449|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15450|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15451|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15452|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15453|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15454|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15455|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15456|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15457|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
21139|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
15458|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15459|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15460|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15461|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15462|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15463|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15464|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15465|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15466|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15467|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15468|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15469|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15470|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15471|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15472|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15473|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15474|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15475|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15476|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15477|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15478|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15479|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15480|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15481|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15482|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15483|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15484|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15485|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15486|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15487|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15488|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15489|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15490|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15491|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15492|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15493|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15494|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15495|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15496|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15497|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15498|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15499|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15500|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15501|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15502|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15503|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15504|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15505|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15506|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15507|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15508|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
21140|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
15509|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15510|NCT02433340|O5|Outcome|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15511|NCT02433340|O4|Outcome|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15512|NCT02433340|O3|Outcome|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15513|NCT02433340|O2|Outcome|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15514|NCT02433340|O1|Outcome|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15515|NCT02433340|E5|Reported Event|All ABT-122 120 mg EOW|Open-label ABT-122 120 mg EOW.
15516|NCT02433340|E4|Reported Event|ABT-122 120 mg EW / 120 mg EOW|Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.
15517|NCT02433340|E3|Reported Event|ABT-122 120 mg EOW / 120 mg EOW|Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15518|NCT02433340|E2|Reported Event|ABT-122 60 mg EOW / 120 mg EOW|Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15519|NCT02433340|E1|Reported Event|ADA 40 mg EOW / ABT-122 120 mg EOW|Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.
15520|NCT02432105|B4|Baseline|Total|Total of all reporting groups
15521|NCT02432105|B3|Baseline|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
15522|NCT02432105|B2|Baseline|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
15523|NCT02432105|B1|Baseline|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
15524|NCT02432105|P3|Participant Flow|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
15525|NCT02432105|P2|Participant Flow|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
15526|NCT02432105|P1|Participant Flow|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
15527|NCT02432105|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
15528|NCT02432105|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
15529|NCT02432105|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
15530|NCT02432105|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
15531|NCT02432105|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
15532|NCT02432105|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
15533|NCT02432105|O3|Outcome|Tubes Only|Bilateral myringotomy and tympanostomy tube insertion
15534|NCT02432105|O2|Outcome|EXE844 3 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
15535|NCT02432105|O1|Outcome|EXE844 7 Days|EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 7 days after Tympanostomy Tube Insertion
15536|NCT02432105|E4|Reported Event|Tubes Only|All participants treated with bilateral myringotomy and tympanostomy tube insertion only
15537|NCT02432105|E3|Reported Event|EXE844 3 Days|All participants treated with EXE844 Sterile Otic Suspension, 0.3% for 3 days after Tympanostomy Tube Insertion
15538|NCT02432105|E2|Reported Event|EXE844 7 Days|All participants treated with EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion
15539|NCT02432105|E1|Reported Event|Pretreatment|All AEs reported prior to randomization
15540|NCT02432040|B3|Baseline|Total|Total of all reporting groups
15541|NCT02432040|B2|Baseline|Placebo|Placebo tablets But patients are still asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
15542|NCT02432040|B1|Baseline|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
15543|NCT02432040|P2|Participant Flow|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
15544|NCT02432040|P1|Participant Flow|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
15545|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
15546|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
15547|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
15548|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
15549|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
15550|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
15551|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
16441|NCT02416973|E3|Reported Event|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings
Provant"
15552|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
15553|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
15554|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
15555|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
15556|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
15557|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
15558|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
15559|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
15560|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
15561|NCT02432040|E2|Reported Event|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
15562|NCT02432040|E1|Reported Event|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
15563|NCT02431754|B3|Baseline|Total|Total of all reporting groups
15564|NCT02431754|B2|Baseline|Placebo/Tadalafil|"Placebo administered once daily orally for 8 weeks in one of two treatment periods.
5 mg tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15565|NCT02431754|B1|Baseline|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered QD orally for 8 weeks in one of two treatment periods.
Placebo administered once daily orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15566|NCT02431754|P2|Participant Flow|Placebo/Tadalafil|"Placebo administered orally QD for 8 weeks in one of two treatment periods.
5 mg tadalafil administered orally QD for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15567|NCT02431754|P1|Participant Flow|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
Placebo administered once daily orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15568|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15569|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15570|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15571|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15572|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15573|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15574|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15575|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15576|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15577|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15578|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
21141|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
15579|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15580|NCT02431754|O2|Outcome|Placebo/Tadalafil|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15581|NCT02431754|O1|Outcome|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15582|NCT02431754|E2|Reported Event|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15583|NCT02431754|E1|Reported Event|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods."
15584|NCT02431741|B1|Baseline|Mepilex Transfer Ag|"Non controlled investigation
Mepilex Transfer Ag"
15585|NCT02431741|P1|Participant Flow|Mepilex Transfer Ag|"Non controlled investigation
Mepilex Transfer Ag"
15586|NCT02431741|O1|Outcome|Mepilex Transfer Ag|"Non controlled investigation
Mepilex Transfer Ag"
15587|NCT02431741|E1|Reported Event|Mepilex Transfer Ag|"Non controlled investigation
Mepilex Transfer Ag"
15589|NCT02431598|P6|Participant Flow|Saline Crossover to Eovist Crossover to Dotarem|Subjects received the agents in this particular order during their MRI.
15590|NCT02431598|P5|Participant Flow|Dotarem Crossover to Saline Crossover to Eovist|Subjects received the agents in this particular order during their MRI.
15591|NCT02431598|P4|Participant Flow|Saline Crossover to Dotarem Crossover to Eovist|Subjects received the agents in this particular order during their MRI.
15592|NCT02431598|P3|Participant Flow|Eovist Crossover to Saline Crossover to Dotarem|Subjects received the agents in this particular order during their MRI.
15593|NCT02431598|P2|Participant Flow|Dotarem Crossover to Eovist Crossover to Saline|Subjects received the agents in this particular order during their MRI.
15594|NCT02431598|P1|Participant Flow|Eovist Crossover to Dotarem Crossover to Saline|Subjects received the agents in this particular order during their MRI.
15595|NCT02431598|O4|Outcome|Last Dynamic Phase|Imaging obtained during late dynamic phase
15596|NCT02431598|O3|Outcome|Portal Venous Phase|Imaging obtained during portal venous phase
15597|NCT02431598|O2|Outcome|Arterial Phase|Imaging obtained during arterial phase
15598|NCT02431598|O1|Outcome|Pre-Contrast Phase|Prior to contrast injection
15599|NCT02431598|O3|Outcome|Saline|Injection of normal saline
15600|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
15601|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
15602|NCT02431598|O3|Outcome|Saline|Injection of normal saline
15603|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
15604|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
15605|NCT02431598|O3|Outcome|Saline|Injection of normal saline
15606|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
15607|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
15608|NCT02431598|O3|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
15609|NCT02431598|O2|Outcome|Saline|Injection of normal saline
15610|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
15611|NCT02431598|O3|Outcome|Saline|
15612|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|
15613|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|
15614|NCT02431598|E3|Reported Event|Saline|
15615|NCT02431598|E2|Reported Event|Dotarem (Gadoterate Dimeglumine)|
15616|NCT02431598|E1|Reported Event|Eovist (Gadoxetate Disodium)|
15617|NCT02431455|B3|Baseline|Total|Total of all reporting groups
15618|NCT02431455|B2|Baseline|No Incentive Spirometry|"No incentive spirometer provided
No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
15619|NCT02431455|B1|Baseline|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake
Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
15620|NCT02431455|P2|Participant Flow|No Incentive Spirometry|"No incentive spirometer provided
No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
15621|NCT02431455|P1|Participant Flow|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake
Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
15622|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided
No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
15623|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake
Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
15624|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided
No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
15625|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake
Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
15986|NCT02424578|O2|Outcome|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days
Diclofenac Capsules high dose"
15626|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided
No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
15627|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake
Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
15628|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided
No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
15629|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake
Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
15630|NCT02431455|E2|Reported Event|No Incentive Spirometry|"No incentive spirometer provided
No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
15631|NCT02431455|E1|Reported Event|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake
Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
15632|NCT02431299|B3|Baseline|Total|Total of all reporting groups
15633|NCT02431299|B2|Baseline|IMR Clinicians|Clinicians who provided the IMR intervention to the IMR Consumers
15634|NCT02431299|B1|Baseline|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
15635|NCT02431299|P2|Participant Flow|IMR Clinicians|The clinicians who provided IMR intervention to the IMR Consumers
15636|NCT02431299|P1|Participant Flow|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
15637|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
15638|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
15639|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
15640|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
15641|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
15642|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
15643|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
15644|NCT02431299|O1|Outcome|IMR Clinicians|Clinicians providing IMR to the IMR consumers.
15645|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
15646|NCT02431299|E2|Reported Event|IMR Clinicians|Clinician participants who are providing Illness Management and Recovery (IMR) intervention.
15647|NCT02431299|E1|Reported Event|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
15648|NCT02430870|B9|Baseline|Total|Total of all reporting groups
15649|NCT02430870|B8|Baseline|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15650|NCT02430870|B7|Baseline|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15651|NCT02430870|B6|Baseline|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15652|NCT02430870|B5|Baseline|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15653|NCT02430870|B4|Baseline|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15654|NCT02430870|B3|Baseline|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15655|NCT02430870|B2|Baseline|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15656|NCT02430870|B1|Baseline|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15657|NCT02430870|P8|Participant Flow|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15658|NCT02430870|P7|Participant Flow|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15659|NCT02430870|P6|Participant Flow|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15987|NCT02424578|O1|Outcome|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days
Diclofenac Capsules low dose"
15660|NCT02430870|P5|Participant Flow|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15661|NCT02430870|P4|Participant Flow|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15662|NCT02430870|P3|Participant Flow|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15663|NCT02430870|P2|Participant Flow|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15664|NCT02430870|P1|Participant Flow|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15665|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15820|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen
Standard oxygen mask: Provide supplemental oxygen"
15666|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15667|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15668|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15669|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15670|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15671|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15672|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15673|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15674|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15675|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15676|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15677|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15678|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15679|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15680|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15681|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15682|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15683|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15684|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15685|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15686|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15687|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15688|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
35496|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
15689|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15690|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15691|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15692|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15693|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15694|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15695|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15696|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15697|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15698|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15699|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15700|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15701|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15702|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15703|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15704|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15705|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
21142|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
15706|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15707|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15708|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15709|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15710|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15711|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15712|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15713|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15714|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15715|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15716|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15717|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15718|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15719|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15720|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15721|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15722|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15723|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15724|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15725|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15726|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15727|NCT02430870|E8|Reported Event|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15728|NCT02430870|E7|Reported Event|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
16442|NCT02416973|E2|Reported Event|Active Treatment|"Active Provant Treatment
Provant"
15729|NCT02430870|E6|Reported Event|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15730|NCT02430870|E5|Reported Event|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15731|NCT02430870|E4|Reported Event|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
15732|NCT02430870|E3|Reported Event|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15733|NCT02430870|E2|Reported Event|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15824|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen
Standard oxygen mask: Provide supplemental oxygen"
35497|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
15734|NCT02430870|E1|Reported Event|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
15735|NCT02430532|B3|Baseline|Total|Total of all reporting groups
15736|NCT02430532|B2|Baseline|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
15737|NCT02430532|B1|Baseline|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
15738|NCT02430532|P2|Participant Flow|Tecfidera 240 mg BID|BG00012 120 mg orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
15739|NCT02430532|P1|Participant Flow|Placebo|BG00012 120 mg capsule orally once a day (QD) supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
15740|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
15741|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
15742|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
15743|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
15744|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
15745|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
15746|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
15747|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
15748|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
15749|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally once a day (QD) supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
15750|NCT02430532|E2|Reported Event|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
15751|NCT02430532|E1|Reported Event|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
15752|NCT02430389|B3|Baseline|Total|Total of all reporting groups
15753|NCT02430389|B2|Baseline|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Placebo"
15754|NCT02430389|B1|Baseline|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
15755|NCT02430389|P2|Participant Flow|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Placebo"
15756|NCT02430389|P1|Participant Flow|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
15757|NCT02430389|O2|Outcome|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Normal Saline: Ninety seconds before pinning, an IV bolus of 10 mL of normal saline will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered"
15815|NCT02428413|B2|Baseline|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.
ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
15758|NCT02430389|O1|Outcome|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Remifentanil: Ninety seconds before pinning, an IV bolus of 10 mL of remifentanil (0.7 µg•kg-1 based on ideal body weight) will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered"
15759|NCT02430389|O2|Outcome|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Placebo"
15760|NCT02430389|O1|Outcome|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
15761|NCT02430389|E2|Reported Event|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Placebo"
15821|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.
ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
15762|NCT02430389|E1|Reported Event|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
15763|NCT02430090|B4|Baseline|Total|Total of all reporting groups
15764|NCT02430090|B3|Baseline|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.
Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.
Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx
Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
15765|NCT02430090|B2|Baseline|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.
Indications:
Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.
Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL
Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
15766|NCT02430090|B1|Baseline|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.
Injection Surgical anaesthesia
Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block
Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
15767|NCT02430090|P3|Participant Flow|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.
Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.
Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx
Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
15768|NCT02430090|P2|Participant Flow|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.
Indications:
Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.
Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL
Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
15769|NCT02430090|P1|Participant Flow|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.
Injection Surgical anaesthesia
Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block
Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
15770|NCT02430090|O3|Outcome|Levobupivacaine + Sufentanil|2 ml of 0.5% levobupivacaine was added to 1 ml of 1,5 µcg sufentanil in group III by intrathecal administration
15771|NCT02430090|O2|Outcome|Levobupivacaine + Fentanyl|2 ml of 0.5% levobupivacaine was added to 1 ml of 15 µcg of fentanyl in group II by intrathecal administration
15772|NCT02430090|O1|Outcome|Levobupivacaine|2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I by intrathecal administration
16443|NCT02416973|E1|Reported Event|Sham of Provant|"Sham of Provant
Provant"
15773|NCT02430090|E3|Reported Event|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.
Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.
Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx
Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
15822|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen
Standard oxygen mask: Provide supplemental oxygen"
15823|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.
ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
15774|NCT02430090|E2|Reported Event|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.
Indications:
Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.
Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL
Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
15775|NCT02430090|E1|Reported Event|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.
Injection Surgical anaesthesia
Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block
Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
15776|NCT02429258|B3|Baseline|Total|Total of all reporting groups
15777|NCT02429258|B2|Baseline|Placebo|Placebo + Metformin or Insulin
15778|NCT02429258|B1|Baseline|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15779|NCT02429258|P2|Participant Flow|Placebo|Placebo + Metformin or Insulin
15780|NCT02429258|P1|Participant Flow|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15781|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
15782|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15783|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
15784|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15785|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
15786|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15787|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
15788|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15789|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
15790|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15791|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
15792|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15793|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
15794|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15795|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
15796|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15797|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
15798|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15799|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
15800|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15801|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
15802|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15803|NCT02429258|E2|Reported Event|Placebo|Placebo + Metformin or Insulin
15804|NCT02429258|E1|Reported Event|Dapagliflozin|Dapagliflozin + Metformin or Insulin
15805|NCT02428478|B1|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.
15806|NCT02428478|P2|Participant Flow|Placebo First, Desipramine Second|Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.
15807|NCT02428478|P1|Participant Flow|Desipramine First, Placebo Second|Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night.
15808|NCT02428478|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
15809|NCT02428478|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
15810|NCT02428478|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
15811|NCT02428478|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
15812|NCT02428478|E2|Reported Event|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
15813|NCT02428478|E1|Reported Event|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
15814|NCT02428413|B3|Baseline|Total|Total of all reporting groups
15816|NCT02428413|B1|Baseline|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen
Standard oxygen mask: Provide supplemental oxygen"
15817|NCT02428413|P2|Participant Flow|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.
ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
15818|NCT02428413|P1|Participant Flow|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen
Standard oxygen mask: Provide supplemental oxygen"
15819|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.
ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
15858|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
15825|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.
ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
15826|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen
Standard oxygen mask: Provide supplemental oxygen"
15827|NCT02428413|E2|Reported Event|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.
ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
15828|NCT02428413|E1|Reported Event|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen
Standard oxygen mask: Provide supplemental oxygen"
15829|NCT02428231|B3|Baseline|Total|Total of all reporting groups
15830|NCT02428231|B2|Baseline|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
15831|NCT02428231|B1|Baseline|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
15832|NCT02428231|P2|Participant Flow|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
15833|NCT02428231|P1|Participant Flow|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg dimethyl fumarate (DMF) twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
15834|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
15835|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
15836|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
15837|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
15838|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
15839|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
15840|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
15841|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
15842|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
15843|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
15988|NCT02424578|E2|Reported Event|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days
Diclofenac Capsules high dose"
15844|NCT02428231|E2|Reported Event|6-Week Titration Arm|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
15845|NCT02428231|E1|Reported Event|Standard 1-Week Titration Arm|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
15846|NCT02427984|B4|Baseline|Total|Total of all reporting groups
15847|NCT02427984|B3|Baseline|Ceramic on Ceramic (CoC)|All the patients of our Division with CoC THA
15848|NCT02427984|B2|Baseline|Controls|All the patients of our Division for primary THA
15849|NCT02427984|B1|Baseline|Metal on Metal (MoM)|All the patients of our Division with MoM THA
15850|NCT02427984|P3|Participant Flow|Ceramic on Ceramic (CoC)|All the patients of our Division with CoC THA
15851|NCT02427984|P2|Participant Flow|Controls|
15852|NCT02427984|P1|Participant Flow|Metal on Metal (MoM)|All the patients of our Division with MoM THA
15853|NCT02427984|O1|Outcome|Metal on Metal (MoM)|
15854|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
15855|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
15856|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
15857|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
15866|NCT02427750|B2|Baseline|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15867|NCT02427750|B1|Baseline|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15868|NCT02427750|P2|Participant Flow|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15869|NCT02427750|P1|Participant Flow|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15870|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
15871|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15872|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
15873|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15874|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
15875|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15876|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
15877|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15878|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
15879|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15880|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
15881|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15882|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
15883|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15884|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
15885|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15886|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
15887|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15888|NCT02427750|E3|Reported Event|Total|
15889|NCT02427750|E2|Reported Event|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15890|NCT02427750|E1|Reported Event|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
15891|NCT02427477|B3|Baseline|Total|Total of all reporting groups
15892|NCT02427477|B2|Baseline|Delefilcon A / Senofilcon A / Delefilcon A|All subjects that randomized to receive this sequence and were dispensed a study lens.
15893|NCT02427477|B1|Baseline|Senofilcon A / Delefilcon A / Senofilcon A|All subjects that randomized to receive this sequence and were dispensed a study lens.
15894|NCT02427477|P2|Participant Flow|Delefilcon A / Senofilcon A / Delefilcon A|Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore delefilcon A contact lens, then wore the senofilcon A second and then wore the delefilcon A contact lens third.
15895|NCT02427477|P1|Participant Flow|Senofilcon A / Delefilcon A/ Senofilcon A|Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.
15896|NCT02427477|O2|Outcome|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
15897|NCT02427477|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
16001|NCT02424149|P1|Participant Flow|Control|No preoperative phenazopyridine
15898|NCT02427477|O2|Outcome|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
15899|NCT02427477|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
15900|NCT02427477|E2|Reported Event|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
15901|NCT02427477|E1|Reported Event|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
15902|NCT02427399|B6|Baseline|Total|Total of all reporting groups
15903|NCT02427399|B5|Baseline|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.
Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
15904|NCT02427399|B4|Baseline|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.
Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
15905|NCT02427399|B3|Baseline|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.
Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
15906|NCT02427399|B2|Baseline|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.
Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
15907|NCT02427399|B1|Baseline|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
15908|NCT02427399|P5|Participant Flow|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.
Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
15945|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15909|NCT02427399|P4|Participant Flow|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.
Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
15910|NCT02427399|P3|Participant Flow|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.
Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
15954|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15955|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15956|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15911|NCT02427399|P2|Participant Flow|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.
Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
15912|NCT02427399|P1|Participant Flow|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
15913|NCT02427399|O5|Outcome|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.
Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
15914|NCT02427399|O4|Outcome|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.
Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
15915|NCT02427399|O3|Outcome|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.
Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
15916|NCT02427399|O2|Outcome|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.
Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
15917|NCT02427399|O1|Outcome|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
15918|NCT02427399|O5|Outcome|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.
Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
16604|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
15919|NCT02427399|O4|Outcome|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.
Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
15920|NCT02427399|O3|Outcome|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.
Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
15921|NCT02427399|O2|Outcome|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.
Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
15922|NCT02427399|O1|Outcome|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
15923|NCT02427399|O5|Outcome|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.
Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
15924|NCT02427399|O4|Outcome|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.
Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
15925|NCT02427399|O3|Outcome|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.
Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
15926|NCT02427399|O2|Outcome|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.
Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
15927|NCT02427399|O1|Outcome|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
15928|NCT02427399|E5|Reported Event|Multimodal|"The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.
Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called."
16605|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
15929|NCT02427399|E4|Reported Event|Phone|"The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.
Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders."
15930|NCT02427399|E3|Reported Event|Email|"The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider’s email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.
Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders."
15931|NCT02427399|E2|Reported Event|Letter and Informational Sheet|"The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient’s primary care provider.
Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests."
15932|NCT02427399|E1|Reported Event|Usual Care / Opportunistic Screening|This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
15933|NCT02425956|B1|Baseline|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®
GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
15934|NCT02425956|P1|Participant Flow|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®
GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
15935|NCT02425956|O1|Outcome|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®
GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
15936|NCT02425956|O1|Outcome|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®
GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
15937|NCT02425956|E1|Reported Event|MRI Imaging of Liver|"GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®
GE Optima/Discovery® MRI data of the liver: GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer"
15938|NCT02425826|B3|Baseline|Total|Total of all reporting groups
15939|NCT02425826|B2|Baseline|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15940|NCT02425826|B1|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15941|NCT02425826|P2|Participant Flow|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15942|NCT02425826|P1|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice a day (BID) during the placebo-controlled phase (Weeks 0-16)
15943|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15944|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
21143|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
15946|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15947|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15948|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15949|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15950|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15951|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15952|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15953|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15957|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15958|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15959|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15960|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15961|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15962|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15963|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15964|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15965|NCT02425826|E3|Reported Event|Apremilast (Weeks 0 - 52)|Includes participants initially randomized to identically matching placebo tablets in the placebo controlled phase as well as participants who were randomized to apremilast; at week 16, participants who were receiving placebo were switched to Apremilast 30 mg PO QD and received Apremilast 30 mg daily for weeks 16-52.
15966|NCT02425826|E2|Reported Event|Placebo BID|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
15967|NCT02425826|E1|Reported Event|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
15968|NCT02424591|B3|Baseline|Total|Total of all reporting groups
15969|NCT02424591|B2|Baseline|Placebo|"placebo group will have standard of care rather than ketamine infusion
Placebo: Placebo IV"
15970|NCT02424591|B1|Baseline|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure
Ketamine: Infusion at a rate of 10 mcg/kg/min"
15971|NCT02424591|P2|Participant Flow|Placebo|"placebo group will have standard of care rather than ketamine infusion
Placebo: Placebo IV"
15972|NCT02424591|P1|Participant Flow|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure
Ketamine: Infusion at a rate of 10 mcg/kg/min"
15973|NCT02424591|O2|Outcome|Placebo|"placebo group will have standard of care rather than ketamine infusion
Placebo: Placebo IV"
15974|NCT02424591|O1|Outcome|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure
Ketamine: Infusion at a rate of 10 mcg/kg/min"
15975|NCT02424591|O2|Outcome|Placebo|"placebo group will have standard of care rather than ketamine infusion
Placebo: Placebo IV"
15976|NCT02424591|O1|Outcome|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure
Ketamine: Infusion at a rate of 10 mcg/kg/min"
15977|NCT02424591|O2|Outcome|Placebo|"placebo group will have standard of care rather than ketamine infusion
Placebo: Placebo IV"
15978|NCT02424591|O1|Outcome|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure
Ketamine: Infusion at a rate of 10 mcg/kg/min"
15979|NCT02424591|E2|Reported Event|Placebo|"placebo group will have standard of care rather than ketamine infusion
Placebo: Placebo IV"
15980|NCT02424591|E1|Reported Event|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure
Ketamine: Infusion at a rate of 10 mcg/kg/min"
15981|NCT02424578|B3|Baseline|Total|Total of all reporting groups
15982|NCT02424578|B2|Baseline|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days
Diclofenac Capsules high dose"
15983|NCT02424578|B1|Baseline|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days
Diclofenac Capsules low dose"
15984|NCT02424578|P2|Participant Flow|Diclofenac Capsules High Dose|"Diclofenac Capsules high dose three times daily for up to three days
Diclofenac Capsules high dose"
15985|NCT02424578|P1|Participant Flow|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days
Diclofenac Capsules low dose"
15989|NCT02424578|E1|Reported Event|Diclofenac Capsules Low Dose|"Diclofenac Capsules low dose three times daily for up to three days
Diclofenac Capsules low dose"
15990|NCT02424565|B1|Baseline|Overall Participants|Total number of participants randomized and treated in the study.
15991|NCT02424565|P2|Participant Flow|First Placebo Balm Then Test Balm|2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of test balm of 9g balm packed in each primary package .
15992|NCT02424565|P1|Participant Flow|First Test Balm Then Placebo Balm|2 ± 0.2 g of test balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of placebo balm of 9g balm packed in each primary package .
15993|NCT02424565|O2|Outcome|Placebo Balm|2 ± 0.2 g of placebo balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
15994|NCT02424565|O1|Outcome|Test Balm|2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
15995|NCT02424565|E2|Reported Event|Placebo Balm|2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
15996|NCT02424565|E1|Reported Event|Test Balm|2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
15997|NCT02424149|B3|Baseline|Total|Total of all reporting groups
15998|NCT02424149|B2|Baseline|Phenazopyridine|Preoperative phenazopyridine
15999|NCT02424149|B1|Baseline|Control|No preoperative phenazopyridine
16000|NCT02424149|P2|Participant Flow|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
16002|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
16003|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
16004|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
16005|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
16006|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
16007|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
16008|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
16009|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
16010|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
16011|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
16012|NCT02424149|E2|Reported Event|Phenazopyridine|Preoperative phenazopyridine
16013|NCT02424149|E1|Reported Event|Control|No preoperative phenazopyridine
16014|NCT02423993|B5|Baseline|Total|Total of all reporting groups
16015|NCT02423993|B4|Baseline|CSII + Standart Education|Patients will be transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by HbA1c. The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.
16016|NCT02423993|B3|Baseline|CSII + Group Education|"Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.
We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII."
16017|NCT02423993|B2|Baseline|SAP + Standart Education|Patients will be transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM will be used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 month. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received
16070|NCT02423447|B1|Baseline|All Study Participants|"Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines.
G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines."
16071|NCT02423447|P2|Participant Flow|G5, Then Electro-Flo|"The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2.
G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
16606|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
16018|NCT02423993|B1|Baseline|SAP + Group Education|"All patients will be transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.
We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII."
16019|NCT02423993|P4|Participant Flow|CSII + Standart Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
16095|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
TNX-201: TNX-201 capsule"
16247|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16020|NCT02423993|P3|Participant Flow|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16021|NCT02423993|P2|Participant Flow|SAP + Standart Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
16022|NCT02423993|P1|Participant Flow|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16023|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
16024|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16072|NCT02423447|P1|Participant Flow|Electro-Flo, Then G5|"The patients were randomized to a series of airway clearance sessions with Electro-Flo on Day 1 and G5 on Day 2.
Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
16073|NCT02423447|O2|Outcome|G5 Arm|"G5 arm
G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
16607|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
16025|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
16026|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16027|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
16028|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16029|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
16030|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16031|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
16074|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm
Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
16075|NCT02423447|O2|Outcome|G5 Arm|"G5 arm
G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
16076|NCT02423447|O1|Outcome|Electro-Flo Arm|Electro-Flo arm Electro-Flo device following the 2012 CFF therapy guidelines
16608|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
16032|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16033|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
16034|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16035|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
16036|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16037|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
16038|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16077|NCT02423447|O2|Outcome|G5 Arm|"G5 arm
G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
16078|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm
Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
16079|NCT02423447|O2|Outcome|G5 Arm|"G5 arm
G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
16039|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
16040|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
35498|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
16041|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
16042|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16043|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
16044|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16045|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
16080|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm
Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
16081|NCT02423447|O2|Outcome|G5 Flimm Fighter Arm|G5 Flimm Fighter arm
16082|NCT02423447|O1|Outcome|ElectroFlo Arm|ElectroFlo Arm
16083|NCT02423447|E2|Reported Event|G5 Flimm Fighter|G5 Flimm Fighter
16084|NCT02423447|E1|Reported Event|Electro Flo|Electro flo
16085|NCT02423408|B3|Baseline|Total|Total of all reporting groups
16046|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16047|NCT02423993|E4|Reported Event|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
16048|NCT02423993|E3|Reported Event|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16049|NCT02423993|E2|Reported Event|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
16050|NCT02423993|E1|Reported Event|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.
We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
16051|NCT02423980|B1|Baseline|G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg|A 1 mg dose of G-Pen was given at an initial clinic visit. After a 1-2 week wash-out, subjects received a 0.5 mg dose of G-Pen™ at a second visit.
16052|NCT02423980|P1|Participant Flow|G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg|A 1 mg dose of glucagon at an initial clinic visit, followed by a 0.5 mg dose of glucagon given at a subsequent clinic visit after a 1-2 week wash-out.
16053|NCT02423980|O2|Outcome|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)
Glucagon"
16054|NCT02423980|O1|Outcome|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)
Glucagon"
16055|NCT02423980|O2|Outcome|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)
Glucagon"
16056|NCT02423980|O1|Outcome|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)
Glucagon"
16057|NCT02423980|O2|Outcome|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)
Glucagon"
16058|NCT02423980|O1|Outcome|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)
Glucagon"
16059|NCT02423980|E2|Reported Event|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)
Glucagon"
16060|NCT02423980|E1|Reported Event|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)
Glucagon"
16061|NCT02423577|B3|Baseline|Total|Total of all reporting groups
16062|NCT02423577|B2|Baseline|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
16063|NCT02423577|B1|Baseline|FF-3 Dry Powder|"FF-3
FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
16064|NCT02423577|P2|Participant Flow|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
16065|NCT02423577|P1|Participant Flow|FF-3 Dry Powder|"FF-3
FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
16066|NCT02423577|O2|Outcome|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
16067|NCT02423577|O1|Outcome|FF-3 Dry Powder|"FF-3
FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
16068|NCT02423577|E2|Reported Event|Placebo|Placebo: Placebo dry powder administered by nasal inhalation
16069|NCT02423577|E1|Reported Event|FF-3 Dry Powder|"FF-3
FF-3 dry powder: FF-3 dry powder administered by nasal inhalation"
16609|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
16086|NCT02423408|B2|Baseline|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
Placebo: Placebo capsule"
16087|NCT02423408|B1|Baseline|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
TNX-201: TNX-201 capsule"
16088|NCT02423408|P2|Participant Flow|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
Placebo: Placebo capsule"
16089|NCT02423408|P1|Participant Flow|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
TNX-201: TNX-201 capsule"
16090|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
Placebo: Placebo capsule"
16091|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
TNX-201: TNX-201 capsule"
16092|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
Placebo: Placebo capsule"
16093|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
TNX-201: TNX-201 capsule"
16094|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
Placebo: Placebo capsule"
16956|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16096|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
Placebo: Placebo capsule"
16097|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
TNX-201: TNX-201 capsule"
16098|NCT02423408|E2|Reported Event|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
Placebo: Placebo capsule"
16099|NCT02423408|E1|Reported Event|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs
TNX-201: TNX-201 capsule"
16100|NCT02423317|B3|Baseline|Total|Total of all reporting groups
16101|NCT02423317|B2|Baseline|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
16102|NCT02423317|B1|Baseline|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
16103|NCT02423317|P2|Participant Flow|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
16104|NCT02423317|P1|Participant Flow|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
16105|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
16106|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
16107|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
16108|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
16109|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
16110|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
16145|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
16146|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16111|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
16112|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
16113|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
16114|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
16157|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
35499|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
16115|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
16116|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
16117|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
16118|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
16119|NCT02423317|E2|Reported Event|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
16120|NCT02423317|E1|Reported Event|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
16121|NCT02423291|B1|Baseline|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.
Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
16122|NCT02423291|P1|Participant Flow|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.
Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
16123|NCT02423291|O1|Outcome|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.
Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
16147|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
16148|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16149|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
16610|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
16124|NCT02423291|E1|Reported Event|Vial for IV Infusion|"This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.
Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle."
16125|NCT02421211|B3|Baseline|Total|Total of all reporting groups
16126|NCT02421211|B2|Baseline|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16127|NCT02421211|B1|Baseline|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16128|NCT02421211|P2|Participant Flow|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16129|NCT02421211|P1|Participant Flow|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16130|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16131|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16132|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16133|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16134|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16135|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16136|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16137|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16138|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16139|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16140|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16141|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16142|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16143|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
16144|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16150|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16151|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
16152|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16153|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
16154|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16155|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
16156|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16158|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16159|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
16160|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16161|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
16162|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16163|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
16164|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16165|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
16166|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16167|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
16168|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16169|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
16170|NCT02421211|E2|Reported Event|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
16171|NCT02421211|E1|Reported Event|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
16172|NCT02421120|B1|Baseline|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses
Ceftolozane/Tazobactam: 1 hour intravenous infusion"
16173|NCT02421120|P1|Participant Flow|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses
Ceftolozane/Tazobactam: 1 hour intravenous infusion"
16174|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses
Ceftolozane/Tazobactam: 1 hour intravenous infusion"
16175|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses
Ceftolozane/Tazobactam: 1 hour intravenous infusion"
16176|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses
Ceftolozane/Tazobactam: 1 hour intravenous infusion"
16177|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses
Ceftolozane/Tazobactam: 1 hour intravenous infusion"
16178|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses
Ceftolozane/Tazobactam: 1 hour intravenous infusion"
16179|NCT02421120|E1|Reported Event|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses
Ceftolozane/Tazobactam: 1 hour intravenous infusion"
16180|NCT02420951|B3|Baseline|Total|Total of all reporting groups
16181|NCT02420951|B2|Baseline|No Injection|"Will not receive injection of bupivacaine prior to catheter removal
No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16182|NCT02420951|B1|Baseline|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal
Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16183|NCT02420951|P2|Participant Flow|No Injection|"Will not receive injection of bupivacaine prior to catheter removal
No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16184|NCT02420951|P1|Participant Flow|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal
Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16185|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal
No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16186|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal
Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16187|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal
No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16188|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal
Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16189|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal
No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16190|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal
Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16191|NCT02420951|E2|Reported Event|No Injection|"Will not receive injection of bupivacaine prior to catheter removal
No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16192|NCT02420951|E1|Reported Event|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal
Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
16193|NCT02420093|B3|Baseline|Total|Total of all reporting groups
16194|NCT02420093|B2|Baseline|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
16195|NCT02420093|B1|Baseline|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.
Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
16196|NCT02420093|P2|Participant Flow|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
16197|NCT02420093|P1|Participant Flow|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.
Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
16198|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
16199|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.
Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
16200|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
16201|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.
Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
16202|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
16218|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16435|NCT02416973|P3|Participant Flow|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings
Provant"
16203|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.
Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
16204|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
16205|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.
Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
35500|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
16206|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
16207|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.
Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
16208|NCT02420093|E2|Reported Event|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
16209|NCT02420093|E1|Reported Event|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.
Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
16210|NCT02420041|B3|Baseline|Total|Total of all reporting groups
16211|NCT02420041|B2|Baseline|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16212|NCT02420041|B1|Baseline|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16213|NCT02420041|P2|Participant Flow|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16214|NCT02420041|P1|Participant Flow|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the sacroiliac joint (SIJ)
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16215|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16216|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16217|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16309|NCT02418026|B3|Baseline|Total|Total of all reporting groups
16436|NCT02416973|P2|Participant Flow|Active Treatment|"Active Provant Treatment
Provant"
16437|NCT02416973|P1|Participant Flow|Sham of Provant|"Sham of Provant
Provant"
16219|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16220|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16221|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16222|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16246|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16223|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16224|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16225|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16226|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16227|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16228|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16229|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16230|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16231|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16232|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16233|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16234|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16235|NCT02420041|E2|Reported Event|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.
Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.
Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
16438|NCT02416973|O3|Outcome|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings
Provant"
16236|NCT02420041|E1|Reported Event|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.
Needle entry point is in the lower one-third of the SIJ
Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
16237|NCT02419521|B1|Baseline|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16238|NCT02419521|P1|Participant Flow|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16239|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16240|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16241|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16242|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16243|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16244|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16245|NCT02419521|O1|Outcome|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16248|NCT02419521|E1|Reported Event|Device|"Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm"
16249|NCT02419313|B1|Baseline|All Study Participants|All participants included in this crossover design.
16250|NCT02419313|P2|Participant Flow|Incobotulinumtoxin A First, Then Placebo|Subjects will all receive injections with incobotulinumtoxinA injections first. At 12 weeks, these subjects will then cross over and receive placebo in the same distribution as their second treatment.
16251|NCT02419313|P1|Participant Flow|Placebo First, Then Incobotulinumtoxin A|Subjects will all receive injections with saline first. At 12 weeks, these subjects will then cross over and receive Xeomin in the same distribution as their second treatment.
16252|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.
incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
16253|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.
Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
16254|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.
incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
16255|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.
Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
16256|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.
incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
16257|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.
Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
16258|NCT02419313|E2|Reported Event|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.
incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
16439|NCT02416973|O2|Outcome|Active Treatment|"Active Provant Treatment
Provant"
16440|NCT02416973|O1|Outcome|Sham of Provant|"Sham of Provant
Provant"
16259|NCT02419313|E1|Reported Event|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.
Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
16260|NCT02419001|B3|Baseline|Total|Total of all reporting groups
16261|NCT02419001|B2|Baseline|High Dose|1 g ceftriaxone and two high doses of SYN-004
16262|NCT02419001|B1|Baseline|Low Dose|1 g ceftriaxone and two low doses of SYN-004
16263|NCT02419001|P2|Participant Flow|High Dose|1 g ceftriaxone and two high doses (150 mg) of SYN-004
16264|NCT02419001|P1|Participant Flow|Low Dose|1 g ceftriaxone and two low doses (75 mg) of SYN-004
16265|NCT02419001|O2|Outcome|Treatment Sequence AC|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
16266|NCT02419001|O1|Outcome|Treatment Sequence AB|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
16357|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle
AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
16267|NCT02419001|O2|Outcome|Treatment Sequence AC|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
16268|NCT02419001|O1|Outcome|Treatment Sequence AB|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
16269|NCT02419001|O2|Outcome|Treatment Sequence AC|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
16270|NCT02419001|O1|Outcome|Treatment Sequence AB|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
16271|NCT02419001|E2|Reported Event|High Dose|1 g ceftriaxone and two high doses of SYN-004
16272|NCT02419001|E1|Reported Event|Low Dose|1 g ceftriaxone and two low doses of SYN-004
16273|NCT02418676|B4|Baseline|Total|Total of all reporting groups
16274|NCT02418676|B3|Baseline|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16275|NCT02418676|B2|Baseline|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16276|NCT02418676|B1|Baseline|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16277|NCT02418676|P3|Participant Flow|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16310|NCT02418026|B2|Baseline|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16311|NCT02418026|B1|Baseline|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16278|NCT02418676|P2|Participant Flow|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16316|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16317|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16318|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
35501|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
16279|NCT02418676|P1|Participant Flow|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16280|NCT02418676|O3|Outcome|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16281|NCT02418676|O2|Outcome|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16282|NCT02418676|O1|Outcome|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16283|NCT02418676|O3|Outcome|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16284|NCT02418676|O2|Outcome|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16312|NCT02418026|P2|Participant Flow|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16313|NCT02418026|P1|Participant Flow|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16314|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16315|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16319|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16320|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16321|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16358|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle
AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
16285|NCT02418676|O1|Outcome|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16286|NCT02418676|E3|Reported Event|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16287|NCT02418676|E2|Reported Event|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16288|NCT02418676|E1|Reported Event|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16289|NCT02418468|B3|Baseline|Total|Total of all reporting groups
16290|NCT02418468|B2|Baseline|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
16291|NCT02418468|B1|Baseline|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
16292|NCT02418468|P2|Participant Flow|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
16293|NCT02418468|P1|Participant Flow|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
16294|NCT02418468|O2|Outcome|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
16295|NCT02418468|O1|Outcome|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
16296|NCT02418468|E2|Reported Event|Placebo|Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
16297|NCT02418468|E1|Reported Event|Indacaterol 150 mcg|Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
16298|NCT02418234|B1|Baseline|TKI-PD|Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment
16299|NCT02418234|P1|Participant Flow|TKI-PD|Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
16300|NCT02418234|O3|Outcome|Other Sites Failures|Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
16301|NCT02418234|O2|Outcome|Brain Limited|Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.
16302|NCT02418234|O1|Outcome|Chest Limited|Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.
16303|NCT02418234|O3|Outcome|Other Sites Failures|Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
16304|NCT02418234|O2|Outcome|Brain Limited|Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.
16305|NCT02418234|O1|Outcome|Chest Limited|Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.
16306|NCT02418234|O1|Outcome|TKI-PD|Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
16307|NCT02418234|O1|Outcome|TKI-PD|
16308|NCT02418234|E1|Reported Event|TKI-PD|Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment.
16322|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16323|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16324|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16325|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16326|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16327|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16328|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16329|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16330|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16331|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16332|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16333|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16334|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16335|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16336|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16337|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16338|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16339|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16340|NCT02418026|E2|Reported Event|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care
hypnosis: Conversational hypnotic induction and therapeutic suggestions"
16341|NCT02418026|E1|Reported Event|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
16342|NCT02417961|B1|Baseline|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
16343|NCT02417961|P1|Participant Flow|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
16344|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
16345|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
16346|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
16347|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
16348|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
16349|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
16350|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
16351|NCT02417961|E1|Reported Event|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
16611|NCT02414828|O1|Outcome|Placebo|Sterile Buffer, Intramuscular (IM)
16352|NCT02417753|B1|Baseline|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle
AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
16353|NCT02417753|P1|Participant Flow|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle
AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
16354|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle
AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
16355|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle
AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
16356|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle
AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
16382|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16359|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle
AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
16360|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle
AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
16361|NCT02417753|E1|Reported Event|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle
AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
16362|NCT02417532|B1|Baseline|Rehabilitation Using REX|"Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
16363|NCT02417532|P1|Participant Flow|Rehabilitation Using REX|"Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
16364|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
16365|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
16366|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
16367|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
16368|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
16369|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
16370|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
16371|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
16372|NCT02417532|E1|Reported Event|Rehabilitation Using REX|"Exercises using Rex mobility assist device
Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
16373|NCT02417376|B3|Baseline|Total|Total of all reporting groups
16374|NCT02417376|B2|Baseline|Control|No periodontal intervention in any form.
16375|NCT02417376|B1|Baseline|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16376|NCT02417376|P2|Participant Flow|Control|No periodontal intervention in any form.
16377|NCT02417376|P1|Participant Flow|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16378|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16430|NCT02417129|E1|Reported Event|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
16431|NCT02416973|B4|Baseline|Total|Total of all reporting groups
16432|NCT02416973|B3|Baseline|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings
Provant"
16433|NCT02416973|B2|Baseline|Active Treatment|"Active Provant Treatment
Provant"
16434|NCT02416973|B1|Baseline|Sham of Provant|"Sham of Provant
Provant"
16379|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16380|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16381|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
35502|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
16383|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16384|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16385|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16386|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16387|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16388|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16389|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16390|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16391|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16392|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16393|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16394|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16395|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16396|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16397|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16398|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16399|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16400|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16401|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16402|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16403|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16404|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16405|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16406|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16407|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16408|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16409|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16410|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16411|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16412|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16413|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16414|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16415|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16416|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
16417|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16418|NCT02417376|E2|Reported Event|Control|No periodontal intervention in any form.
16419|NCT02417376|E1|Reported Event|Experimental|"Periodontal intervention in the form of scaling and root planing by:
ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
Gracey curettes: set of 7 instruments number #1-14"
16420|NCT02417129|B1|Baseline|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
16421|NCT02417129|P2|Participant Flow|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
16422|NCT02417129|P1|Participant Flow|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
16423|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
16424|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
16425|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
16426|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
16427|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
16428|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
16429|NCT02417129|E2|Reported Event|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
16612|NCT02414828|E4|Reported Event|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
16444|NCT02416180|B1|Baseline|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
16445|NCT02416180|P1|Participant Flow|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via metered dose inhaler (MDI) for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI Patient Information Leaflet (PIL) and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
16446|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
16473|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon IR"
16510|NCT02415439|P9|Participant Flow|VBP15- 1.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
16447|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
16448|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
16449|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
16450|NCT02416180|E1|Reported Event|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
16451|NCT02415959|B6|Baseline|Total|Total of all reporting groups
16452|NCT02415959|B5|Baseline|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon® (DR/GR)"
16453|NCT02415959|B4|Baseline|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon IR"
16454|NCT02415959|B3|Baseline|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)
Creon IR"
16455|NCT02415959|B2|Baseline|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)
Creon IR"
16456|NCT02415959|B1|Baseline|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)
Creon IR"
16457|NCT02415959|P5|Participant Flow|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon® (DR/GR)"
16458|NCT02415959|P4|Participant Flow|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon IR"
16459|NCT02415959|P3|Participant Flow|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)
Creon IR"
16460|NCT02415959|P2|Participant Flow|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)
Creon IR"
16461|NCT02415959|P1|Participant Flow|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)
Creon IR"
16462|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon® (DR/GR)"
16463|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon IR"
16464|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)
Creon IR"
16465|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)
Creon IR"
16466|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)
Creon IR"
16499|NCT02415439|B7|Baseline|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions
16467|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon® (DR/GR)"
16468|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon IR"
16469|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)
Creon IR"
16470|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)
Creon IR"
16471|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)
Creon IR"
16472|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon® (DR/GR)"
16474|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)
Creon IR"
16475|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)
Creon IR"
16476|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)
Creon IR"
16477|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon® (DR/GR)"
16478|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon IR"
16479|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)
Creon IR"
16480|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)
Creon IR"
16481|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)
Creon IR"
16482|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon® (DR/GR)"
16483|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon IR"
16484|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)
Creon IR"
16485|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)
Creon IR"
16486|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)
Creon IR"
16487|NCT02415959|E5|Reported Event|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon® (DR/GR)"
16488|NCT02415959|E4|Reported Event|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)
Creon IR"
16489|NCT02415959|E3|Reported Event|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)
Creon IR"
16490|NCT02415959|E2|Reported Event|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)
Creon IR"
16491|NCT02415959|E1|Reported Event|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)
Creon IR"
16492|NCT02415439|B14|Baseline|Total|Total of all reporting groups
16493|NCT02415439|B13|Baseline|Placebo MAD|Subjects were orally administered placebo daily for 14 days under fasted conditions
16494|NCT02415439|B12|Baseline|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions
16495|NCT02415439|B11|Baseline|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions
16496|NCT02415439|B10|Baseline|VBP15 - 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions
16497|NCT02415439|B9|Baseline|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions
16498|NCT02415439|B8|Baseline|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions
16500|NCT02415439|B6|Baseline|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal
16501|NCT02415439|B5|Baseline|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions
16502|NCT02415439|B4|Baseline|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions
16503|NCT02415439|B3|Baseline|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions
16504|NCT02415439|B2|Baseline|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions
16505|NCT02415439|B1|Baseline|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions
16506|NCT02415439|P13|Participant Flow|Placebo MAD|Subjects were orally administered placebo daily for 14 days under fasted conditions.
16507|NCT02415439|P12|Participant Flow|VBP15- 20 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
16508|NCT02415439|P11|Participant Flow|VBP15- 9.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
16509|NCT02415439|P10|Participant Flow|VBP15- 3.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
16511|NCT02415439|P8|Participant Flow|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions.
16512|NCT02415439|P7|Participant Flow|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.
16513|NCT02415439|P6|Participant Flow|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal.
16514|NCT02415439|P5|Participant Flow|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
16515|NCT02415439|P4|Participant Flow|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
16516|NCT02415439|P3|Participant Flow|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
16517|NCT02415439|P2|Participant Flow|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
16518|NCT02415439|P1|Participant Flow|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
16519|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
16520|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
16521|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
16522|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
16523|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
16524|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
16525|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
16526|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
16527|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
16528|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
16529|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
16530|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
16531|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
16532|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
16533|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
16534|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
16535|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
16536|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
16537|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasting SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
16538|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
16539|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
16540|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
16541|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
16542|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
16543|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
16544|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
16603|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
16545|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasted SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
16546|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
16547|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
16548|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
16549|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
16550|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
16551|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
16552|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
16553|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasting SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
16554|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
16555|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
16556|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
16557|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
16558|NCT02415439|E13|Reported Event|Placebo MAD|Subjects were orally administered a dose of placebo daily for 14 days under fasted conditions.
16559|NCT02415439|E12|Reported Event|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
16560|NCT02415439|E11|Reported Event|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
16561|NCT02415439|E10|Reported Event|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
16562|NCT02415439|E9|Reported Event|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
16563|NCT02415439|E8|Reported Event|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions.
16564|NCT02415439|E7|Reported Event|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
16565|NCT02415439|E6|Reported Event|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
16566|NCT02415439|E5|Reported Event|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
16567|NCT02415439|E4|Reported Event|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
16568|NCT02415439|E3|Reported Event|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
16569|NCT02415439|E2|Reported Event|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
16570|NCT02415439|E1|Reported Event|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
16571|NCT02414828|B5|Baseline|Total|Total of all reporting groups
16572|NCT02414828|B4|Baseline|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
16573|NCT02414828|B3|Baseline|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
16574|NCT02414828|B2|Baseline|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
16575|NCT02414828|B1|Baseline|Placebo|Sterile buffer, Intramuscular (IM)
16576|NCT02414828|P4|Participant Flow|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
16577|NCT02414828|P3|Participant Flow|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
16578|NCT02414828|P2|Participant Flow|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
16579|NCT02414828|P1|Participant Flow|Placebo|Sterile buffer, Intramuscular (IM)
16580|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
16581|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
16582|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
16583|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
16584|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
16585|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
16586|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
16587|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
16588|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
16589|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
16590|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
16591|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
16592|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
16593|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
16594|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
16595|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
16596|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
16597|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
16598|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
16599|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
16600|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
16601|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
16602|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
16613|NCT02414828|E3|Reported Event|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
16614|NCT02414828|E2|Reported Event|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
16615|NCT02414828|E1|Reported Event|Placebo|Sterile buffer, Intramuscular (IM)
16616|NCT02414152|B1|Baseline|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection
anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
16617|NCT02414152|P1|Participant Flow|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection
anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
16618|NCT02414152|O1|Outcome|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection
anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
16619|NCT02414152|E1|Reported Event|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection
anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
16620|NCT02413879|B1|Baseline|Treatment Arm|All study subjects will be treated using the CleanCision device.
16621|NCT02413879|P1|Participant Flow|Treatment Group|All study subjects were treated using the CleanCision device.
16622|NCT02413879|O1|Outcome|Treatment Arm|All study subjects will be treated using the CleanCision device.
16623|NCT02413879|O1|Outcome|Treatment Arm|All study subjects will be treated using the CleanCision device.
16624|NCT02413879|O1|Outcome|Treatment Arm|All study subjects will be treated using the CleanCision device.
16625|NCT02413879|E1|Reported Event|Treatment Arm|All study subjects will be treated using the CleanCision device.
16626|NCT02413593|B1|Baseline|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16627|NCT02413593|P1|Participant Flow|LDV/SOF+RBV|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16628|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16629|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16630|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16631|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16632|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16633|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16634|NCT02413593|E1|Reported Event|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16635|NCT02413333|B5|Baseline|Total|Total of all reporting groups
16636|NCT02413333|B4|Baseline|PeroxiClear, Then PeroxiClear|PeroxiClear was used in Period 1 and in Period 2.
16637|NCT02413333|B3|Baseline|Clear Care Plus, Then Clear Care Plus|Clear Care Plus was used in Period 1 and in Period 2.
16638|NCT02413333|B2|Baseline|PeroxiClear, Then Clear Care Plus|PeroxiClear was used in Period 1, then Clear Care Plus in Period 2.
16639|NCT02413333|B1|Baseline|Clear Care Plus, Then PeroxiClear|Clear Care Plus was used in Period 1, then PeroxiClear in Period 2.
16640|NCT02413333|P2|Participant Flow|PeroxiClear, Then Clear Care Plus|PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
16641|NCT02413333|P1|Participant Flow|Clear Care Plus, Then PeroxiClear|Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
16642|NCT02413333|O2|Outcome|Clear Care Plus|Clear Care Plus Lens Cases
16643|NCT02413333|O1|Outcome|PeroxiClear|PeroxiClear Lens Cases
16644|NCT02413333|O2|Outcome|Clear Care Plus|Clear Care Plus Lens Cases
16645|NCT02413333|O1|Outcome|PeroxiClear|PeroxiClear Lens Cases
16646|NCT02413333|E2|Reported Event|Clear Care Plus|While using Clear Care Plus
16647|NCT02413333|E1|Reported Event|PeroxiClear|While using PeroxiClear
16648|NCT02413294|B1|Baseline|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16649|NCT02413294|P1|Participant Flow|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16684|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.
Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
16685|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration."
16650|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16651|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16652|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16653|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16654|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16655|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16656|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16657|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16658|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16659|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16660|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16939|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16661|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16662|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16663|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16664|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16665|NCT02413294|E1|Reported Event|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
16666|NCT02413203|B3|Baseline|Total|Total of all reporting groups
16667|NCT02413203|B2|Baseline|Placebo|"Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration."
16668|NCT02413203|B1|Baseline|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.
Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
16669|NCT02413203|P2|Participant Flow|Placebo|"Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration."
16670|NCT02413203|P1|Participant Flow|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.
Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
16671|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration."
16672|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.
Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
16673|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration."
16674|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.
Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
16675|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration."
16676|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.
Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
16677|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration."
16678|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.
Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
16679|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration."
16680|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.
Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
16681|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration."
16682|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.
Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
16683|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration."
16849|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16686|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.
Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
16687|NCT02413203|E2|Reported Event|Placebo|"Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration."
16688|NCT02413203|E1|Reported Event|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.
Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
16689|NCT02413034|B3|Baseline|Total|Total of all reporting groups
16690|NCT02413034|B2|Baseline|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
16691|NCT02413034|B1|Baseline|Control Group|No antibiotic prophylaxis
16692|NCT02413034|P2|Participant Flow|Study Group|Cefazolin: Cefazolin (vancomycin in the case of allergy to cefazolin)
16693|NCT02413034|P1|Participant Flow|Control Group|No antibiotic prophylaxis
16694|NCT02413034|O2|Outcome|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
16695|NCT02413034|O1|Outcome|Control Group|No antibiotic prophylaxis
16696|NCT02413034|O2|Outcome|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
16697|NCT02413034|O1|Outcome|Control Group|No antibiotic prophylaxis
16698|NCT02413034|E2|Reported Event|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
16699|NCT02413034|E1|Reported Event|Control Group|No antibiotic prophylaxis
16700|NCT02412657|B4|Baseline|Total|Total of all reporting groups
16701|NCT02412657|B3|Baseline|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Normal Saline"
16702|NCT02412657|B2|Baseline|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
16703|NCT02412657|B1|Baseline|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block
Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
16704|NCT02412657|P3|Participant Flow|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Normal Saline"
16705|NCT02412657|P2|Participant Flow|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
16706|NCT02412657|P1|Participant Flow|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block
Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
16707|NCT02412657|O3|Outcome|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Normal Saline"
16708|NCT02412657|O2|Outcome|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
16709|NCT02412657|O1|Outcome|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block
Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
16710|NCT02412657|E3|Reported Event|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Normal Saline"
16711|NCT02412657|E2|Reported Event|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
16712|NCT02412657|E1|Reported Event|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block
Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
16713|NCT02411929|B1|Baseline|Ertugliflozin|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
16941|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16714|NCT02411929|P1|Participant Flow|Ertugliflozin|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
16715|NCT02411929|O2|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart).
16716|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
16717|NCT02411929|O2|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart).
16860|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16957|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16718|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
16719|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
16720|NCT02411929|O1|Outcome|14^C-Ertugliflozin 100 ug Oral|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C administered orally after the unlabeled oral dose (no more than 5 minutes apart) on Day 1 of Period 2.
16721|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
16722|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
16723|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
16724|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
16725|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
16726|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
16727|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
16728|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
16729|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
16730|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
16731|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
16732|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
16733|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
16734|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
16735|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
16736|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
16737|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
16738|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
16739|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
16740|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
16741|NCT02411929|E2|Reported Event|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart.)
16850|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16942|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16742|NCT02411929|E1|Reported Event|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
16743|NCT02411747|B3|Baseline|Total|Total of all reporting groups
16744|NCT02411747|B2|Baseline|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy by simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by a expert in the procedure. Total max. time: 2 hours.
Oral expert lecture Simulation training"
16745|NCT02411747|B1|Baseline|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with a expert in the procedure. Total max time: 2 hours.
Directed self-regulated simulation training Testing"
16746|NCT02411747|P2|Participant Flow|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.
Oral expert lecture Simulation training"
16861|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
36499|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
16747|NCT02411747|P1|Participant Flow|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.
Directed self-regulated simulation training Testing"
16748|NCT02411747|O2|Outcome|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.
Oral expert lecture Simulation training"
16749|NCT02411747|O1|Outcome|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.
Directed self-regulated simulation training Testing"
16750|NCT02411747|E2|Reported Event|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.
Oral expert lecture Simulation training"
16751|NCT02411747|E1|Reported Event|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.
Directed self-regulated simulation training Testing"
16752|NCT02411539|B3|Baseline|Total|Total of all reporting groups
16753|NCT02411539|B2|Baseline|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16754|NCT02411539|B1|Baseline|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16755|NCT02411539|P2|Participant Flow|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16756|NCT02411539|P1|Participant Flow|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16757|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16758|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16759|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16760|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16761|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16762|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16851|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16763|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16764|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16765|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16862|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
37774|NCT02185534|B7|Baseline|Total|Total of all reporting groups
16766|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16767|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16768|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16769|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16770|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16771|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo (normal saline) at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16772|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16773|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16774|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16775|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16776|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16777|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16778|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16779|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16780|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16852|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16781|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16782|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16783|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16784|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16785|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16786|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16787|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16788|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16789|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16790|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16791|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16792|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16793|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16794|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16795|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16796|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16797|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16798|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16853|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
21144|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
16799|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16800|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16801|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16802|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16803|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16804|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16805|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16806|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16807|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16808|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16809|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16810|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16811|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16812|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16813|NCT02411539|O1|Outcome|Across Arms|Compare the pre-VRC01 and post-VRC01 time points across randomized Arms A/B. Arm A participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. Arm B participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. This group is to identify analyses that were assessed across randomized arms between the pre- and post-VRC01 time points.
16814|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16815|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16816|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16854|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16817|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16818|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16819|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16820|NCT02411539|O2|Outcome|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16821|NCT02411539|O1|Outcome|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16822|NCT02411539|E2|Reported Event|Arm B: Placebo Followed by VRC01|"Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16823|NCT02411539|E1|Reported Event|Arm A: VRC01 Followed by Placebo|"Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump"
16824|NCT02411201|B1|Baseline|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
16825|NCT02411201|P1|Participant Flow|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
16826|NCT02411201|O2|Outcome|Pre- + Post-contrast|Lesion visualization was assessed after DOTAREM injection
16827|NCT02411201|O1|Outcome|Pre-contrast|Lesion visualization was assessed before DOTAREM injection
16828|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
16829|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
16830|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
16831|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
16832|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
16833|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
16834|NCT02411201|E1|Reported Event|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
16835|NCT02410824|B1|Baseline|Overall Baseline Characteristics|Participants were randomized to wear stenfilcon A toric lens or etafilcon A toric lens bilaterally for one week, then cross over to the alternative pair.
16836|NCT02410824|P2|Participant Flow|Etafilcon A Toric Lens, Then Stenfilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week, then cross over to the stenfilcon A toric lens.
etafilcon A: toric contact lens
stenfilcon A: toric contact lens"
16837|NCT02410824|P1|Participant Flow|Stenfilcon A Toric Lens, Then Etafilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week, then cross over to the etafilcon A toric lens.
stenfilcon A: toric contact lens
etafilcon A: toric contact lens"
16838|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16839|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16840|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16841|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16842|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16843|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16844|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16845|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16846|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16847|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16848|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
21145|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
16855|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16856|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16857|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16858|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16859|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric lens contact lens"
16954|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16863|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16864|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16865|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16866|NCT02410824|E2|Reported Event|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens"
16867|NCT02410824|E1|Reported Event|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens"
16868|NCT02410291|B3|Baseline|Total|Total of all reporting groups
16869|NCT02410291|B2|Baseline|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
16870|NCT02410291|B1|Baseline|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.
Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
16871|NCT02410291|P2|Participant Flow|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
16872|NCT02410291|P1|Participant Flow|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.
Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
16873|NCT02410291|O2|Outcome|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
16896|NCT02408692|O2|Outcome|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
16940|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16874|NCT02410291|O1|Outcome|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.
Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
16875|NCT02410291|E2|Reported Event|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
16876|NCT02410291|E1|Reported Event|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.
Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
16877|NCT02410200|B1|Baseline|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
16878|NCT02410200|P1|Participant Flow|BG00012|BG00012 taken orally at a dose of 120 mg twice daily (BID) for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
16879|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
16880|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
16881|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
16882|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
16883|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
16884|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
16885|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
16886|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
16887|NCT02410200|E1|Reported Event|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
16888|NCT02408692|B4|Baseline|Total|Total of all reporting groups
16889|NCT02408692|B3|Baseline|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG
ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
16890|NCT02408692|B2|Baseline|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
16891|NCT02408692|B1|Baseline|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
16892|NCT02408692|P3|Participant Flow|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG
ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
16893|NCT02408692|P2|Participant Flow|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
16894|NCT02408692|P1|Participant Flow|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
16895|NCT02408692|O3|Outcome|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG
ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
16938|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16897|NCT02408692|O1|Outcome|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
16898|NCT02408692|O3|Outcome|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG
ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
16899|NCT02408692|O2|Outcome|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
16900|NCT02408692|O1|Outcome|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
16955|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
38045|NCT02181517|B4|Baseline|Total|Total of all reporting groups
16901|NCT02408692|E3|Reported Event|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG
ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
16902|NCT02408692|E2|Reported Event|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
16903|NCT02408692|E1|Reported Event|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
16904|NCT02406937|B4|Baseline|Total|Total of all reporting groups
16905|NCT02406937|B3|Baseline|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16906|NCT02406937|B2|Baseline|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16907|NCT02406937|B1|Baseline|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16908|NCT02406937|P3|Participant Flow|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16909|NCT02406937|P2|Participant Flow|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16910|NCT02406937|P1|Participant Flow|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16911|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Breast Feeding: Oral intake of breast milk"
16912|NCT02406937|O2|Outcome|Feihe Stage 1 Formula|"Oral intake of Feihe stage 1 formula
Oral intake of Feihe Stage 1 Formula: Oral intake of Feihe Stage 1 Formula"
16913|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake of Feihe New Formula: Oral intake of Feihe New Formula"
16914|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16915|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16916|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16917|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16918|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16919|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16920|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16921|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16922|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16923|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16924|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16925|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16926|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16927|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16928|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16929|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16930|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16931|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16932|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16933|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16934|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16935|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16936|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16937|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16943|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16944|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16945|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16946|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16947|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16948|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16949|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16950|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16951|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16952|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16953|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16958|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16959|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16960|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16961|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16962|NCT02406937|E3|Reported Event|Breast Feeding|"Oral intake of breast milk
Oral intake: Oral intake"
16963|NCT02406937|E2|Reported Event|Feihe Formula|"Oral intake of Feihe stage 1 formula
Oral intake: Oral intake"
16964|NCT02406937|E1|Reported Event|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Oral intake: Oral intake"
16965|NCT02406586|B4|Baseline|Total|Total of all reporting groups
16966|NCT02406586|B3|Baseline|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
16967|NCT02406586|B2|Baseline|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16968|NCT02406586|B1|Baseline|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16969|NCT02406586|P3|Participant Flow|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
16970|NCT02406586|P2|Participant Flow|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16971|NCT02406586|P1|Participant Flow|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16972|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
16973|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16974|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16975|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
16976|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16977|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16978|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
16979|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17039|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17998|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10mg ODM-106 Capsule A
16980|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16981|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
16982|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16983|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16984|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
16985|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16986|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16987|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
16988|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16989|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16990|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
16991|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16992|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17375|NCT02403180|E2|Reported Event|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
16993|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
16994|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16995|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16996|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
16997|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16998|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
16999|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
17000|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17001|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17002|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
17003|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17004|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17005|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
17006|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17007|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17008|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
17009|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17032|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17010|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17011|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
17012|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17040|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17126|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17013|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17014|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
17015|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17016|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17017|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
17018|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17019|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17020|NCT02406586|E3|Reported Event|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
17021|NCT02406586|E2|Reported Event|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17022|NCT02406586|E1|Reported Event|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
17023|NCT02406495|B1|Baseline|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17024|NCT02406495|P1|Participant Flow|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17025|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17026|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17027|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17028|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17029|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17030|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17031|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17033|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17034|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17035|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17036|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17037|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17038|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
40439|NCT02158273|O2|Outcome|Placebo|Matched Placebo
17041|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17042|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17043|NCT02406495|O4|Outcome|Ocufilcon D OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17044|NCT02406495|O3|Outcome|Ocufilcon D OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17045|NCT02406495|O2|Outcome|Filcon IV 1 OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17046|NCT02406495|O1|Outcome|Filcon IV 1 OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17047|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17048|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17049|NCT02406495|O4|Outcome|Ocufilcon D OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17050|NCT02406495|O3|Outcome|Ocufilcon D OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17051|NCT02406495|O2|Outcome|Filcon IV 1 OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17052|NCT02406495|O1|Outcome|Filcon IV 1 OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17053|NCT02406495|O4|Outcome|Ocufilcon D OS (Oculus Sinister)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17054|NCT02406495|O3|Outcome|Ocufilcon D OD (Oculus Dexter)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17055|NCT02406495|O2|Outcome|Filcon IV 1 OS (Oculus Sinister)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17056|NCT02406495|O1|Outcome|Filcon IV 1 OD (Oculus Dexter)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17057|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17058|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17059|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17060|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17061|NCT02406495|E1|Reported Event|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens"
17062|NCT02405429|B1|Baseline|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
17063|NCT02405429|P1|Participant Flow|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
17064|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
17065|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
17066|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
17067|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
17068|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
17069|NCT02405429|E1|Reported Event|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
17070|NCT02405390|B3|Baseline|Total|Total of all reporting groups
17071|NCT02405390|B2|Baseline|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope
Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
Storz C-Mac® laryngoscope"
17072|NCT02405390|B1|Baseline|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope
Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
Storz C-Mac® laryngoscope"
17073|NCT02405390|P2|Participant Flow|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope
Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
Storz C-Mac® laryngoscope"
17074|NCT02405390|P1|Participant Flow|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope
Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
Storz C-Mac® laryngoscope"
17075|NCT02405390|O2|Outcome|Direct Laryngoscopy|Some patients will be intubated with a direct (conventional) laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
17076|NCT02405390|O1|Outcome|Video Laryngoscopy|Some patients will be intubated with a video laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
17077|NCT02405390|O2|Outcome|Direct Laryngoscopy|Some patients will be intubated with a direct (conventional) laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
17078|NCT02405390|O1|Outcome|Video Laryngoscopy|Some patients will be intubated with a video laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
17079|NCT02405390|E2|Reported Event|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope
Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
Storz C-Mac® laryngoscope"
17080|NCT02405390|E1|Reported Event|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope
Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
Storz C-Mac® laryngoscope"
17081|NCT02404649|B3|Baseline|Total|Total of all reporting groups
17082|NCT02404649|B2|Baseline|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.
sinus elevation only"
17083|NCT02404649|B1|Baseline|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.
sinus bone augmentation"
17084|NCT02404649|P2|Participant Flow|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.
sinus elevation only"
17085|NCT02404649|P1|Participant Flow|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.
sinus bone augmentation"
17086|NCT02404649|O2|Outcome|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.
sinus elevation only"
17115|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17116|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17459|NCT02402127|O1|Outcome|TruEye|Narafilcon A contact lenses
17087|NCT02404649|O1|Outcome|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.
sinus bone augmentation"
17122|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17123|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17124|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17125|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17088|NCT02404649|E2|Reported Event|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.
sinus elevation only"
17089|NCT02404649|E1|Reported Event|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.
sinus bone augmentation"
17090|NCT02404545|B3|Baseline|Total|Total of all reporting groups
17091|NCT02404545|B2|Baseline|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.
Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
17092|NCT02404545|B1|Baseline|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
17093|NCT02404545|P2|Participant Flow|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.
Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
17094|NCT02404545|P1|Participant Flow|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
17095|NCT02404545|O1|Outcome|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.
Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
17096|NCT02404545|O2|Outcome|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.
Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
17097|NCT02404545|O1|Outcome|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
17098|NCT02404545|E2|Reported Event|Group 2 - Ileal Conduit With Mesh|"Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.
Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit."
17099|NCT02404545|E1|Reported Event|Group 1 - Ideal Conduit No Mesh|No mesh will be placed at the time of radical cystectomy and ileal conduit.
17100|NCT02404493|B3|Baseline|Total|Total of all reporting groups
17101|NCT02404493|B2|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17102|NCT02404493|B1|Baseline|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17103|NCT02404493|P2|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17104|NCT02404493|P1|Participant Flow|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17105|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17106|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17107|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17108|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17109|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17110|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17111|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17112|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17113|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17114|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
18933|NCT02379637|B1|Baseline|A N-acetylcysteine|"N-acetylcysteine
N-acetylcysteine"
17117|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17118|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17119|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17120|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17121|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17127|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17128|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17129|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17130|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17131|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17132|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17133|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17134|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17135|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17136|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17137|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17138|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17139|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17140|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17141|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17142|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17143|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17144|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17145|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17146|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17147|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17148|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17149|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17150|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17151|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17152|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17153|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17154|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17155|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17156|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17157|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
18934|NCT02379637|P2|Participant Flow|B Placebo|"Placebo
Placebo, matching capsules three times daily"
17158|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17159|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17160|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17161|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17162|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17163|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17164|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17165|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17166|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17167|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17168|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17169|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17170|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17171|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17172|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17173|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17174|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17175|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17176|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17177|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17178|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17179|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17180|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17181|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17182|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17183|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17184|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17185|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17186|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17187|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17188|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17189|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17190|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17191|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17192|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17193|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17194|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17195|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17196|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17197|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17198|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
18975|NCT02376530|O1|Outcome|Usual Shopping|No change in condition.
17199|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17200|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17201|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17202|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17203|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17204|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17205|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17206|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17207|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17208|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17209|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17210|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17211|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17212|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17213|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17214|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17215|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17216|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17217|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17218|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17219|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17220|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17221|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17222|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17223|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17224|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17225|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17226|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17227|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17228|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17229|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17230|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17231|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17232|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17233|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17234|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17235|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17236|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17237|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17238|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17239|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
21146|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
17240|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17241|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17242|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17243|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17244|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17245|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17246|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17247|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17248|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17249|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17250|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17251|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17252|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17253|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17254|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17255|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17256|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17257|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17258|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17259|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17260|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17261|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17262|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17263|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17264|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17265|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17266|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17267|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17268|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17269|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17270|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17271|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17272|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17273|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17274|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17275|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17276|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17277|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17278|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17279|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17280|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
21147|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
17281|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17282|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17283|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17284|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17285|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17286|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17287|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17288|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17289|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17290|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17291|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17292|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17293|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17294|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17295|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17296|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17297|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17298|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17299|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17300|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17301|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17302|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17303|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17304|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17305|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17306|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17307|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17308|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17309|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17310|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17311|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17312|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17313|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17314|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17315|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17316|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17317|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17318|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17319|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17320|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17321|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
21148|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
17322|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17323|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17324|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17325|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17326|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17327|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17328|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17329|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17330|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17331|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17332|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17333|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17334|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17335|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17336|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17337|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17338|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17339|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17340|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17341|NCT02404493|E2|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
17342|NCT02404493|E1|Reported Event|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
17343|NCT02403830|B1|Baseline|Whole Study Population|Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm.
17344|NCT02403830|P2|Participant Flow|Placebo First|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. In this arm patients received placebo at visit 1. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm (methylnaltrexone).
Placebo: Placebo will be administered as a 0.9% sodium chloride iv injection
Morphine: After methylnaltrexone, patients will receive 5-mg intravenous morphine
Ticagrelor: After morphine administration, patients will receive a 180-mg ticagrelor loading dose"
17345|NCT02403830|P1|Participant Flow|Methylnaltrexone First|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. In this arm patients received methylnaltrexone at visit 1. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm (placebo).
Methylnaltrexone: Methylnaltrexone will be administered diluted with 5 ml of normal saline as a single iv bolus
Morphine: After methylnaltrexone, patients will receive 5-mg intravenous morphine
Ticagrelor: After morphine administration, patients will receive a 180-mg ticagrelor loading dose"
17346|NCT02403830|O2|Outcome|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.
Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
17347|NCT02403830|O1|Outcome|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.
Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
17348|NCT02403830|O2|Outcome|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.
Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
17349|NCT02403830|O1|Outcome|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.
Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
17386|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
17387|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
17350|NCT02403830|O2|Outcome|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.
Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
17351|NCT02403830|O1|Outcome|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.
Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
17352|NCT02403830|E2|Reported Event|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.
Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
17353|NCT02403830|E1|Reported Event|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.
Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
17354|NCT02403206|B3|Baseline|Total|Total of all reporting groups
17355|NCT02403206|B2|Baseline|Manual (CCC)|CCC performed during cataract surgery
17356|NCT02403206|B1|Baseline|Laser (LSX)|Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
17357|NCT02403206|P2|Participant Flow|Manual (CCC)|Continuous curvilinear capsulorhexis (CCC) performed during cataract surgery
17358|NCT02403206|P1|Participant Flow|Laser (LSX)|Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
17359|NCT02403206|O2|Outcome|Manual (CCC)|CCC performed during cataract surgery
17360|NCT02403206|O1|Outcome|Laser (LSX)|Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
17361|NCT02403206|O2|Outcome|Manual (CCC)|CCC performed during cataract surgery
17362|NCT02403206|O1|Outcome|Laser (LSX)|Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
17363|NCT02403206|E3|Reported Event|Manual (CCC)|Subjects who underwent CCC-assisted cataract surgery
17364|NCT02403206|E2|Reported Event|Laser (LSX)|Subjects who underwent femtosecond laser-assisted cataract surgery
17365|NCT02403206|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to initiation of study treatment
17366|NCT02403180|B3|Baseline|Total|Total of all reporting groups
17367|NCT02403180|B2|Baseline|PROCLEAR 1D MF, Then DACP MF|Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2.
17368|NCT02403180|B1|Baseline|DACP MF, Then PROCLEAR 1D MF|Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2.
17369|NCT02403180|P2|Participant Flow|PROCLEAR 1D MF, Then DACP MF|Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
17370|NCT02403180|P1|Participant Flow|DACP MF, Then PROCLEAR 1D MF|Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
17371|NCT02403180|O2|Outcome|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
17372|NCT02403180|O1|Outcome|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
17373|NCT02403180|O2|Outcome|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
17374|NCT02403180|O1|Outcome|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
21149|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
17376|NCT02403180|E1|Reported Event|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
17377|NCT02402933|B1|Baseline|Nasal Glucagon|Glucagon: 3 mg glucagon powder
17378|NCT02402933|P1|Participant Flow|Nasal Glucagon|Four doses of AMG504-1 (3 mg glucagon powder per dose) were dispensed to participants and each participant/caregiver were encouraged to keep one dose with them at all times and the other doses in a convenient location.
17379|NCT02402933|O1|Outcome|Nasal Glucagon|3 mg glucagon powder
17380|NCT02402933|O1|Outcome|Nasal Glucagon|3 mg glucagon powder
17381|NCT02402933|O1|Outcome|Nasal Glucagon|3 mg glucagon powder
17382|NCT02402933|O1|Outcome|Nasal Glucagon|3 mg glucagon powder
17383|NCT02402933|E1|Reported Event|Nasal Glucagon|3 mg glucagon powder
17384|NCT02402764|B1|Baseline|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
17385|NCT02402764|P1|Participant Flow|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
17388|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
17389|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
17390|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
17391|NCT02402764|E1|Reported Event|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
17392|NCT02402322|B4|Baseline|Total|Total of all reporting groups
17393|NCT02402322|B3|Baseline|Waiting List|Participants in a waiting list.
17394|NCT02402322|B2|Baseline|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17395|NCT02402322|B1|Baseline|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17396|NCT02402322|P3|Participant Flow|Waiting List|Participants in a waiting list.
17397|NCT02402322|P2|Participant Flow|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17398|NCT02402322|P1|Participant Flow|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17399|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
17400|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17401|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17402|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
17403|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17404|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17405|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
17406|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17407|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17408|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
17460|NCT02402127|O3|Outcome|Clariti 1day|Somofilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
17461|NCT02402127|O2|Outcome|MyDay|Stenfilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
17409|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17410|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17411|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
17412|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17413|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17414|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
17938|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
17415|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17416|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17417|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
17418|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17419|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17420|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
17421|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17422|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17423|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
17424|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17425|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17426|NCT02402322|E3|Reported Event|Waiting List|Participants in a waiting list.
17427|NCT02402322|E2|Reported Event|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.
Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
17428|NCT02402322|E1|Reported Event|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.
Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
17429|NCT02402296|B3|Baseline|Total|Total of all reporting groups
17430|NCT02402296|B2|Baseline|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.
Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
17431|NCT02402296|B1|Baseline|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.
β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
17432|NCT02402296|P2|Participant Flow|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.
β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
17462|NCT02402127|O1|Outcome|TruEye|Narafilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
21150|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
17433|NCT02402296|P1|Participant Flow|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.
Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
17434|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.
β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
17435|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.
Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
17436|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.
β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
17437|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.
Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
17438|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.
β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
17439|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.
Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
17440|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.
β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
17441|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.
Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
17442|NCT02402296|E2|Reported Event|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.
β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
17443|NCT02402296|E1|Reported Event|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.
Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
17444|NCT02402127|B7|Baseline|Total|Total of all reporting groups
17445|NCT02402127|B6|Baseline|Clariti 1day, MyDay, TruEye|Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
17446|NCT02402127|B5|Baseline|Clariti 1day, TruEye, MyDay|Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
17447|NCT02402127|B4|Baseline|MyDay, Clariti 1day, TruEye|Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
17448|NCT02402127|B3|Baseline|MyDay, TruEye, Clariti 1day|Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
17449|NCT02402127|B2|Baseline|TruEye, Clariti 1day, MyDay|Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
17450|NCT02402127|B1|Baseline|TruEye, MyDay, Clariti 1day|Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
17451|NCT02402127|P6|Participant Flow|Clariti 1day, MyDay, TruEye|Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
17452|NCT02402127|P5|Participant Flow|Clariti 1day, TruEye, MyDay|Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
17453|NCT02402127|P4|Participant Flow|MyDay, Clariti 1day, TruEye|Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
17454|NCT02402127|P3|Participant Flow|MyDay, TruEye, Clariti 1day|Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
17455|NCT02402127|P2|Participant Flow|TruEye, Clariti 1day, MyDay|Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
17456|NCT02402127|P1|Participant Flow|TruEye, MyDay, Clariti 1day|Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
17457|NCT02402127|O3|Outcome|Clariti 1day|Somofilcon A contact lenses
17458|NCT02402127|O2|Outcome|MyDay|Stenfilcon A contact lenses
17463|NCT02402127|E3|Reported Event|Clariti 1day|Somofilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
17464|NCT02402127|E2|Reported Event|MyDay|Stenfilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
17465|NCT02402127|E1|Reported Event|TruEye|Narafilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
17466|NCT02401867|B1|Baseline|Full Sample|Descriptive characteristics for the full sample (n=150).
17467|NCT02401867|P1|Participant Flow|Overall Sample|Overall sample reported as all participants received both the self and the provider swab.
17468|NCT02401867|O2|Outcome|Participants With a Negative Cervical HPV DNA Test Result|Negative result determined by reference test: provider cervical HPV DNA Hybridization assay
17469|NCT02401867|O1|Outcome|Participants With Positive Cervical HPV DNA Test Result|Positive result determined by reference test: provider cervical HPV DNA Hybridization assay
17470|NCT02401867|E1|Reported Event|Full Sample|Descriptive characteristics for the full sample (n=150).
17471|NCT02401555|B4|Baseline|Total|Total of all reporting groups
17472|NCT02401555|B3|Baseline|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17473|NCT02401555|B2|Baseline|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17474|NCT02401555|B1|Baseline|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17475|NCT02401555|P3|Participant Flow|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17476|NCT02401555|P2|Participant Flow|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17477|NCT02401555|P1|Participant Flow|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17478|NCT02401555|O3|Outcome|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17479|NCT02401555|O2|Outcome|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17480|NCT02401555|O1|Outcome|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17481|NCT02401555|E3|Reported Event|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17482|NCT02401555|E2|Reported Event|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17483|NCT02401555|E1|Reported Event|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
17484|NCT02401529|B3|Baseline|Total|Total of all reporting groups
17485|NCT02401529|B2|Baseline|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17486|NCT02401529|B1|Baseline|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17487|NCT02401529|P2|Participant Flow|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17488|NCT02401529|P1|Participant Flow|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17489|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17490|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17491|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17492|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17493|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17542|NCT02401464|O2|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17494|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
Number of participants when started 59"
17495|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17496|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17497|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17498|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17499|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17500|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17501|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17502|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17503|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17504|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17505|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17506|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17507|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17508|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17509|NCT02401529|E2|Reported Event|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours
IV saline: IV saline"
17510|NCT02401529|E1|Reported Event|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone: 0.15 mg/kg
Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
17511|NCT02401464|B5|Baseline|Total|Total of all reporting groups
17512|NCT02401464|B4|Baseline|Granule Cohort: TAK-536 Tablet + TAK-536 Granules|Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
17513|NCT02401464|B3|Baseline|Granule Cohort: TAK-536 Granules + TAK-536 Tablet|Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
17514|NCT02401464|B2|Baseline|Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup|Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
17543|NCT02401464|O1|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17515|NCT02401464|B1|Baseline|Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet|Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
17516|NCT02401464|P4|Participant Flow|Granule Cohort: TAK-536 Tablet + TAK-536 Granules|Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
17517|NCT02401464|P3|Participant Flow|Granule Cohort: TAK-536 Granules + TAK-536 Tablet|Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
17518|NCT02401464|P2|Participant Flow|Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup|Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
17519|NCT02401464|P1|Participant Flow|Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet|Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
17520|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17521|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17522|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17523|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
17524|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17525|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17526|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17527|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
17528|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17529|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17530|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17531|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
17532|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17533|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17534|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17535|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
17536|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17701|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17537|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17538|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17539|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
17540|NCT02401464|O2|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17541|NCT02401464|O1|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
41447|NCT02151994|E15|Reported Event|100 mg (MAD Period)|MAD period
17544|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17545|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
17546|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17547|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
17548|NCT02401464|E4|Reported Event|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17549|NCT02401464|E3|Reported Event|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17550|NCT02401464|E2|Reported Event|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
17551|NCT02401464|E1|Reported Event|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
17552|NCT02400996|B1|Baseline|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
17553|NCT02400996|P1|Participant Flow|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
17554|NCT02400996|O1|Outcome|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
17555|NCT02400996|E1|Reported Event|Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
17556|NCT02400710|B3|Baseline|Total|Total of all reporting groups
17557|NCT02400710|B2|Baseline|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
17558|NCT02400710|B1|Baseline|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.
Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
17559|NCT02400710|P2|Participant Flow|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
17560|NCT02400710|P1|Participant Flow|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.
Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
17561|NCT02400710|O2|Outcome|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
17562|NCT02400710|O1|Outcome|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.
Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
21151|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
17563|NCT02400710|O2|Outcome|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
17564|NCT02400710|O1|Outcome|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.
Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
17565|NCT02400710|E2|Reported Event|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
17566|NCT02400710|E1|Reported Event|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.
Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
17995|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
17567|NCT02400346|B1|Baseline|Adjunct Brexpiprazole|"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.
Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.
Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."
17568|NCT02400346|P1|Participant Flow|Adjunct Brexpiprazole|"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.
Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.
Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."
17569|NCT02400346|O1|Outcome|Adjunct Brexpiprazole|"All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.
Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.
Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."
17570|NCT02400346|E1|Reported Event|Brex + ADT|
17571|NCT02400333|B5|Baseline|Total|Total of all reporting groups
17572|NCT02400333|B4|Baseline|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
17573|NCT02400333|B3|Baseline|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
17574|NCT02400333|B2|Baseline|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
17575|NCT02400333|B1|Baseline|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
17576|NCT02400333|P4|Participant Flow|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
17577|NCT02400333|P3|Participant Flow|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
17578|NCT02400333|P2|Participant Flow|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
17579|NCT02400333|P1|Participant Flow|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
17580|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17581|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17582|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17583|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17584|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17585|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17586|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17587|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17588|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17589|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17590|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17591|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17592|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17593|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17594|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17595|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17596|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17597|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17598|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17599|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17600|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17601|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17602|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17603|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17604|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17605|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17606|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17607|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17608|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17609|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17610|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17611|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17612|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17613|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17614|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17615|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17616|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17617|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17618|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17619|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17620|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17621|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17622|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17623|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17624|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17625|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17626|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17627|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17628|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17629|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a nasogastric tube (NG) tube into the stomach (total of 200 mL of water).
17630|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17631|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17632|NCT02400333|E4|Reported Event|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
17633|NCT02400333|E3|Reported Event|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
17634|NCT02400333|E2|Reported Event|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
17635|NCT02400333|E1|Reported Event|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
17665|NCT02399163|E1|Reported Event|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
17636|NCT02399345|B1|Baseline|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
17637|NCT02399345|P1|Participant Flow|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
17638|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
17639|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
17640|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
17641|NCT02399345|E1|Reported Event|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
17642|NCT02399163|B1|Baseline|Overall Participants|All randomized participants were evaluated for baseline characteristics
17643|NCT02399163|P1|Participant Flow|Overall Study|"In this cross-over study, participants were randomized to receive each of following treatments:
Fluoride dentifrice/Fluoride rinse
Placebo dentifrice/Fluoride rinse
Fluoride dentifrice/No rinse
Placebo dentifrice/No rinse"
17644|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
17645|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
17646|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
17647|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
17648|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
17649|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
17650|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
17651|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
17652|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
17653|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
17654|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
17655|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
17656|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
17657|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
17658|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
17659|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
17660|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
21152|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
17661|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 parts per million (ppm) of fluoride as sodium fluoride
17662|NCT02399163|E4|Reported Event|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
17663|NCT02399163|E3|Reported Event|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
17664|NCT02399163|E2|Reported Event|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
17666|NCT02399111|B5|Baseline|Total|Total of all reporting groups
17996|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
17667|NCT02399111|B4|Baseline|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
17668|NCT02399111|B3|Baseline|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
17669|NCT02399111|B2|Baseline|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
17670|NCT02399111|B1|Baseline|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
17671|NCT02399111|P4|Participant Flow|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
17672|NCT02399111|P3|Participant Flow|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
17673|NCT02399111|P2|Participant Flow|Obese:BMI≥30; Standard Care|Obese: BMI ≥30; Standard Wound Care
17674|NCT02399111|P1|Participant Flow|Not Obese:BMI<30; Standard Care|Not obese: BMI< 30; Standard Wound Care
17675|NCT02399111|O4|Outcome|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
17676|NCT02399111|O3|Outcome|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
17677|NCT02399111|O2|Outcome|Obese:BMI≥30; Standard Care|Standard Wound Care
17678|NCT02399111|O1|Outcome|Not Obese:BMI<30; Standard Care|Standard Wound Care
17702|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
21153|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
17679|NCT02399111|O4|Outcome|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
17707|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17708|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17680|NCT02399111|O3|Outcome|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
17681|NCT02399111|O2|Outcome|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
17682|NCT02399111|O1|Outcome|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
17683|NCT02399111|E4|Reported Event|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
17684|NCT02399111|E3|Reported Event|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
17685|NCT02399111|E2|Reported Event|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
17686|NCT02399111|E1|Reported Event|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
17687|NCT02397915|B1|Baseline|FF 110 µg /MF 200 µg or MF 200 µg /FF 110 µg|All participants received treatments in one of two treatment sequences, Sequence 1: two sprays of FF (total of 110 µg) in each nostril (total 4 sprays) in Period 1 and two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) in Period 2; Sequence 2: FF (110 µg) followed by MF (total of 200 µg) and MF (total of 200 µg) followed by FF (110 µg) in Period 2. Two study treatments were administered 30 minutes (+/-5) apart by a third party administrator using a metered nasal spray.
17688|NCT02397915|P4|Participant Flow|Period 2: FF 110 µg|Participants received FF (total dose of 110 µg) in each nostril (total 4 sprays).
17689|NCT02397915|P3|Participant Flow|Period 2: MF 200 µg|Participants received two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays).
17690|NCT02397915|P2|Participant Flow|Period 1: MF 200 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
17691|NCT02397915|P1|Participant Flow|Period 1: FF 110 µg|Participants received two sprays of FF (total dose of 110 micrograms [µg]) in each nostril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
17692|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17693|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17694|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17695|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17696|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17697|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17698|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17699|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17700|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17878|NCT02394808|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the duration of the study.
17703|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17704|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17705|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17706|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17709|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17710|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17711|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17712|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17713|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17714|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17715|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17716|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17717|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17718|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17719|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17720|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17721|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17722|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17723|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17724|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17725|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17726|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17727|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17728|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17729|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17730|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17731|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17732|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17733|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17734|NCT02397915|O2|Outcome|MF 200 µg /FF 110 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
17735|NCT02397915|O1|Outcome|FF 110 µg /MF 200 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
17879|NCT02394808|P2|Participant Flow|Lotrafilcon B/Senofilcon A|Subjects randomized to this sequence first wore the lotrafilcon B lens and then wore the senofilcon A lens.
17736|NCT02397915|O2|Outcome|MF 200 µg /FF 110 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
17737|NCT02397915|O1|Outcome|FF 110 µg /MF 200 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
17738|NCT02397915|E2|Reported Event|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
17739|NCT02397915|E1|Reported Event|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
41448|NCT02151994|E14|Reported Event|50 mg (MAD Period)|MAD period
17740|NCT02397655|B1|Baseline|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
17741|NCT02397655|P1|Participant Flow|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
17742|NCT02397655|O1|Outcome|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
17743|NCT02397655|E1|Reported Event|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
17744|NCT02397564|B1|Baseline|Treatment Group|"Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment.
Er:YAG laser, traditional and fractional settings: Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting"
17745|NCT02397564|P1|Participant Flow|Intervention Group|"Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment.
Er:YAG laser, traditional and fractional settings: Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting"
17746|NCT02397564|O1|Outcome|Treatment Group|Number of patients that preferred the fractionated laser.
17747|NCT02397564|O1|Outcome|Treatment Group|Subjects receiving treatment for scar
17748|NCT02397564|E1|Reported Event|Treatment Group|Those who went laser treatment.
17749|NCT02396537|B3|Baseline|Total|Total of all reporting groups
17750|NCT02396537|B2|Baseline|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam
Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.
0.9% Saline: Administered intranasally prior to Midazolam administration."
17751|NCT02396537|B1|Baseline|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam
Lidocaine: Administered intranasally prior to Midazolam administration.
Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
17752|NCT02396537|P2|Participant Flow|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam
Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.
0.9% Saline: Administered intranasally prior to Midazolam administration."
17753|NCT02396537|P1|Participant Flow|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam
Lidocaine: Administered intranasally prior to Midazolam administration.
Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
17754|NCT02396537|O2|Outcome|Intranasal 0.9% Saline|Subjects were administered 0.9% saline, 0.5 ml in each naris, 5 minutes prior to intranasal midazolam (placebo group).
17755|NCT02396537|O1|Outcome|Intranasal Lidocaine|Subjects were administered 4% lidocaine solution, 0.5 ml in each naris, 5 minutes prior to intranasal midazolam (intervention group).
17756|NCT02396537|E2|Reported Event|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam
Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.
0.9% Saline: Administered intranasally prior to Midazolam administration."
17757|NCT02396537|E1|Reported Event|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam
Lidocaine: Administered intranasally prior to Midazolam administration.
Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
17758|NCT02396316|B3|Baseline|Total|Total of all reporting groups
17759|NCT02396316|B2|Baseline|Sham Injection Group|Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.
17760|NCT02396316|B1|Baseline|Aflibercept 2 mg Intravitreal (IVT) Injection Group|Subjects received intravitreal (IVT) injection of 2 mg (0.05 milliliter [ml] * 40 milligram per milliliter [mg/ml]) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.
17761|NCT02396316|P2|Participant Flow|Sham Injection Group|Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.
17813|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17762|NCT02396316|P1|Participant Flow|Aflibercept 2 mg Intravitreal (IVT) Injection Group|Subjects received intravitreal (IVT) injection of 2 mg (0.05 milliliter [ml] * 40 milligram per milliliter [mg/ml]) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.
17763|NCT02396316|O2|Outcome|Sham Injection Group|Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.
17764|NCT02396316|O1|Outcome|Aflibercept 2 mg Intravitreal (IVT) Injection Group|Subjects received intravitreal (IVT) injection of 2 mg (0.05 milliliter [ml] * 40 milligram per milliliter [mg/ml]) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.
17765|NCT02396316|O2|Outcome|Sham Injection Group|Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.
17766|NCT02396316|O1|Outcome|Aflibercept 2 mg Intravitreal (IVT) Injection Group|Subjects received intravitreal (IVT) injection of 2 mg (0.05 milliliter [ml] * 40 milligram per milliliter [mg/ml]) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.
17767|NCT02396316|E2|Reported Event|Sham Injection Group|Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.
17768|NCT02396316|E1|Reported Event|Aflibercept 2 mg Intravitreal (IVT) Injection Group|Subjects received intravitreal (IVT) injection of 2 mg (0.05 ml * 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.
17769|NCT02396160|B3|Baseline|Total|Total of all reporting groups
17770|NCT02396160|B2|Baseline|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
17771|NCT02396160|B1|Baseline|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root
Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
17772|NCT02396160|P2|Participant Flow|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
17773|NCT02396160|P1|Participant Flow|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root
Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
17774|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
17775|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root
Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
17776|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
17777|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root
Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
17778|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
17779|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root
Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
17780|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
17781|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root
Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
17782|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
17783|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root
Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
17784|NCT02396160|E2|Reported Event|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
17785|NCT02396160|E1|Reported Event|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root
Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
17786|NCT02396147|B3|Baseline|Total|Total of all reporting groups
17877|NCT02394925|E1|Reported Event|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
17787|NCT02396147|B2|Baseline|Arm 2: T2-A + T4C-D + T4C-E|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
17788|NCT02396147|B1|Baseline|Arm 1: T2-A + T4B-B + T4B-C|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
17818|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17789|NCT02396147|P2|Participant Flow|Arm 2: T2-A + T4C-D + T4C-E|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
17790|NCT02396147|P1|Participant Flow|Arm 1: T2-A + T4B-B + T4B-C|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
17791|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17792|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17793|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17794|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17795|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17796|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17797|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17798|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17799|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17800|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17801|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17802|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17803|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17804|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17805|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17806|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17807|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17808|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17809|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17810|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17811|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17812|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17814|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17815|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17816|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17817|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17819|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17820|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17821|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17822|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17823|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17824|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17825|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17826|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17827|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17828|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17829|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17830|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17831|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17832|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17833|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17834|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17835|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17836|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17837|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17838|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17839|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17840|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17841|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17842|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17843|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17844|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17845|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17846|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17847|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17848|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17849|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17850|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17851|NCT02396147|E6|Reported Event|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17852|NCT02396147|E5|Reported Event|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17853|NCT02396147|E4|Reported Event|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17854|NCT02396147|E3|Reported Event|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17855|NCT02396147|E2|Reported Event|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17856|NCT02396147|E1|Reported Event|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
17857|NCT02395302|B1|Baseline|Dual Action Pneumatic Compression|"Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
Dual Action Pneumatic Compression: Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period."
17858|NCT02395302|P1|Participant Flow|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet. Subjects that received the dual action pneumatic compression device were instructed to use the device in sustained mode for fourteen hours per day and in intermittent mode for three hours per day during the four week treatment period.
17859|NCT02395302|O1|Outcome|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
17860|NCT02395302|E1|Reported Event|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
17861|NCT02395055|B3|Baseline|Total|Total of all reporting groups
17862|NCT02395055|B2|Baseline|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17863|NCT02395055|B1|Baseline|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17864|NCT02395055|P2|Participant Flow|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17865|NCT02395055|P1|Participant Flow|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17866|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17867|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17868|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17869|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17870|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17871|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17872|NCT02395055|E2|Reported Event|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17873|NCT02395055|E1|Reported Event|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
17874|NCT02394925|B1|Baseline|Dispensed Subjects|All subjects in that were dispensed the study lens.
17875|NCT02394925|P1|Participant Flow|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
17876|NCT02394925|O1|Outcome|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
17880|NCT02394808|P1|Participant Flow|Senofilcon A/ Lotrafilcon B|Subjects randomized to this sequence first wore the senofilcon A lens and then wore the lotrafilcon B lens.
17881|NCT02394808|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens in either the first or second period of the study.
17882|NCT02394808|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the first or second period of the study.
17883|NCT02394808|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens in either the first or second period of the study.
17884|NCT02394808|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the first or second period of the study.
17885|NCT02394808|E2|Reported Event|Lotrafilcon B|Subjects that wore the lotrafilcon B lens in either the first or second period of the study.
17886|NCT02394808|E1|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in either the first or second period of the study.
17887|NCT02394756|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least 1 study lens.
17888|NCT02394756|P6|Participant Flow|Comfilcon A/Lotrafilcon B/Senofilcon A|Subjects randomized to this sequence wore the comfilcon A lens in the first period, the lotrafilcon B lens in the second period and the senofilcon A lens in the third period.
17889|NCT02394756|P5|Participant Flow|Comfilcon A/Senofilcon A/ Lotrafilcon B|Subjects randomized to this sequence wore the comfilcon A lens in the first period, the senofilcon A lens in the second period and the lotrafilcon B lens in the third period.
17890|NCT02394756|P4|Participant Flow|Lotrafilcon B/Senofilcon A/Comfilcon A|Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the senofilcon A lens in the second period and the comfilcon A lens in the third period.
17891|NCT02394756|P3|Participant Flow|Lotrafilcon B/Comfilcon A/Senofilcon A|Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the comfilcon A lens in the second period and the senofilcon A lens in the third period.
17892|NCT02394756|P2|Participant Flow|Senfilcon A/Comfilcon A/Lotrafilcon B|Subjects randomized to this sequence wore the senofilcon A lens in the first period, the comfilcon A lens in the second period and the lotrafilcon B lens in the third period.
17893|NCT02394756|P1|Participant Flow|Senofilcon A/Lotrafilcon B/Comfilcon A|Subjects randomized to this sequence wore the senofilcon A lens in the first period, the lotrafilcon B lens in the second period and the comfilcon A lens in the third period.
17894|NCT02394756|O3|Outcome|Comfilcon A|Subjects wore the comfilcon A lens in any of the three periods during the study.
17895|NCT02394756|O2|Outcome|Lotrafilcon B|Subjects wore the lotrafilcon B lens in any of the three periods during the study.
17896|NCT02394756|O1|Outcome|Senofilcon A|Subjects wore the senofilcon A lens in any of the three periods during the study.
17897|NCT02394756|O3|Outcome|Comfilcon A|Subjects wore the comfilcon A lens in any of the three periods during the study.
17898|NCT02394756|O2|Outcome|Lotrafilcon B|Subjects wore the lotrafilcon B lens in any of the three periods during the study.
17899|NCT02394756|O1|Outcome|Senofilcon A|Subjects wore the senofilcon A lens in any of the three periods during the study.
17900|NCT02394756|E3|Reported Event|Comfilcon A|Subjects wore the comfilcon A lens in any of the three periods during the study.
17901|NCT02394756|E2|Reported Event|Lotrafilcon B|Subjects wore the lotrafilcon B lens in any of the three periods during the study.
17902|NCT02394756|E1|Reported Event|Senofilcon A|Subjects wore the senofilcon A lens in any of the three periods during the study.
17903|NCT02394665|B4|Baseline|Total|Total of all reporting groups
17904|NCT02394665|B3|Baseline|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:
Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17905|NCT02394665|B2|Baseline|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17906|NCT02394665|B1|Baseline|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
17907|NCT02394665|P3|Participant Flow|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:
Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17908|NCT02394665|P2|Participant Flow|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17909|NCT02394665|P1|Participant Flow|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
17910|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:
Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17932|NCT02394457|P1|Participant Flow|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
21154|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
17911|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17912|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
17913|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:
Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17914|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17915|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
17916|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:
Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17917|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17918|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
17919|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:
Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17920|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17921|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
17922|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:
Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17923|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17924|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
17925|NCT02394665|E3|Reported Event|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:
Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17926|NCT02394665|E2|Reported Event|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
Adjuvant Temozolomide Therapy for up to 12 cycles."
17927|NCT02394665|E1|Reported Event|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
17928|NCT02394457|B3|Baseline|Total|Total of all reporting groups
17929|NCT02394457|B2|Baseline|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
17930|NCT02394457|B1|Baseline|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
17931|NCT02394457|P2|Participant Flow|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
17933|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
17934|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
17935|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
17936|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
17937|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
17997|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
17939|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
17940|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
17941|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
17942|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
17943|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
17944|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
17945|NCT02394457|E2|Reported Event|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
17946|NCT02394457|E1|Reported Event|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
17947|NCT02393950|B3|Baseline|Total|Total of all reporting groups
17948|NCT02393950|B2|Baseline|Panel 2|Single oral doses ODM-106 Capsule B 100, 100, 200 mg. ODM-106 Capsule A 100mg, placebo
17949|NCT02393950|B1|Baseline|Panel 1|Single oral doses ODM-106 Capsule B 2, 10, 25, 50mg, placebo
17950|NCT02393950|P2|Participant Flow|Panel 2|Single oral doses ODM-106 Capsule B: 100, 100, 200mg. ODM-106 Capsule A 100 mg , placebo
17951|NCT02393950|P1|Participant Flow|Panel 1|Single oral doses ODM-106 Capsule B: 2, 10, 25, 50 mg , placebo
17952|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
17953|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10mg ODM-106 Capsule A
17954|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10mg ODM-106 Capsule B
17955|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10mg ODM-106 Capsule B
17956|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100mg ODM-106 Capsule B
17957|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10mg ODM-106 Capsule B
17958|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
17959|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
17960|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
17961|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
17962|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A.
17963|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B.
17964|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B.
17965|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B.
17966|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B.
17967|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B.
17968|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B.
17969|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B.
17970|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
17971|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A.
17972|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
17973|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B.
17974|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
17975|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
17976|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5mg ODM-106 Capsule B
17977|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
17978|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
17979|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
17980|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
17981|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
17982|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
17983|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
17984|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
17985|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg and 1 x 5 mg ODM-106 Capsule B
17986|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
17987|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
17988|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
17989|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
17990|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
17991|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
17992|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
17993|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
17994|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg and 1 x 5 mg ODM-106 Capsule B
17999|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10mg ODM-106 Capsule B
18000|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10mg ODM-106 Capsule B
18001|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100mg ODM-106 Capsule B
18002|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10mg ODM-106 Capsule B
18003|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
18004|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
18005|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
18006|NCT02393950|E9|Reported Event|Placebo|2 placebo subjects per Arm with matched number of placebo capsules
18007|NCT02393950|E8|Reported Event|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
18008|NCT02393950|E7|Reported Event|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
18009|NCT02393950|E6|Reported Event|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
18010|NCT02393950|E5|Reported Event|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
18011|NCT02393950|E4|Reported Event|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
18012|NCT02393950|E3|Reported Event|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B
18013|NCT02393950|E2|Reported Event|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
18014|NCT02393950|E1|Reported Event|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
18015|NCT02393677|B3|Baseline|Total|Total of all reporting groups
18016|NCT02393677|B2|Baseline|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist
Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
18017|NCT02393677|B1|Baseline|Ropivacaine|"amide local anesthetic
Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
18018|NCT02393677|P2|Participant Flow|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist
Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
18019|NCT02393677|P1|Participant Flow|Ropivacaine|"amide local anesthetic
Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
18020|NCT02393677|O2|Outcome|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist
Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
18021|NCT02393677|O1|Outcome|Ropivacaine|"amide local anesthetic
Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
18022|NCT02393677|E2|Reported Event|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist
Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
18023|NCT02393677|E1|Reported Event|Ropivacaine|"amide local anesthetic
Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
18024|NCT02393547|B1|Baseline|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin
Varenicline: All subjects receive Varenicline
Lorcaserin: All subjects receive Lorcaserin"
18025|NCT02393547|P1|Participant Flow|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin
Varenicline: All subjects receive Varenicline
Lorcaserin: All subjects receive Lorcaserin"
18026|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin
Varenicline: All subjects receive Varenicline
Lorcaserin: All subjects receive Lorcaserin"
18027|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin
Varenicline: All subjects receive Varenicline
Lorcaserin: All subjects receive Lorcaserin"
18028|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin
Varenicline: All subjects receive Varenicline
Lorcaserin: All subjects receive Lorcaserin"
18029|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin
Varenicline: All subjects receive Varenicline
Lorcaserin: All subjects receive Lorcaserin"
18030|NCT02393547|E1|Reported Event|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin
Varenicline: All subjects receive Varenicline
Lorcaserin: All subjects receive Lorcaserin"
18031|NCT02392767|B3|Baseline|Total|Total of all reporting groups
18032|NCT02392767|B2|Baseline|First Placebo, Then Verum|2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
18423|NCT02388347|P1|Participant Flow|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
18033|NCT02392767|B1|Baseline|First Verum, Then Placebo|2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
18034|NCT02392767|P2|Participant Flow|First Placebo, Then Verum|2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
18035|NCT02392767|P1|Participant Flow|First Verum, Then Placebo|2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
18036|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks
Placebo: corn starch"
18037|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.
Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
18038|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.
Placebo: corn starch"
18039|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.
Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
18040|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.
Placebo: corn starch"
18041|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.
Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
18042|NCT02392767|O2|Outcome|Placebo|2 times 2 tablets a day for 4 weeks. Placebo: corn starch
18043|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.
Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
18044|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks
Placebo: corn starch"
18045|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.
Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
18046|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.
Placebo: corn starch"
18047|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.
Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
18048|NCT02392767|E2|Reported Event|Placebo|"2 times 2 tablets a day for 4 weeks.
Placebo: corn starch"
18049|NCT02392767|E1|Reported Event|Verum|"2 times 2 tablets a day for 4 weeks.
Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
18050|NCT02392247|B1|Baseline|Cardiac Surgery Patients|Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. Paired blood samples were assessed by thromboelastography (TEG; current care option) and by Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry
18051|NCT02392247|P1|Participant Flow|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.
Blood specimen collection"
18052|NCT02392247|O1|Outcome|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.
Blood specimen collection"
18053|NCT02392247|O1|Outcome|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.
Blood specimen collection"
18054|NCT02392247|E1|Reported Event|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry
Blood specimen collection"
18055|NCT02392208|B1|Baseline|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.
Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
18056|NCT02392208|P1|Participant Flow|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.
Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
18105|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
18108|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18057|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.
Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
18058|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.
Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
18112|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18059|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.
Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
18060|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.
Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
18061|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.
Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
18062|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.
Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
18063|NCT02392208|E2|Reported Event|Telavancin After Hemodialysis|"Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.
Telavancin: A single 5 mg/kg dose of telavancin is administered intravenously (IV).
Pharmacokinetic Blood Sampling: Blood samples are collected to assess telavancin plasma concentrations."
18064|NCT02392208|E1|Reported Event|Telavancin Before Hemodialysis|"Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.
Telavancin: A single 5 mg/kg dose of telavancin is administered intravenously (IV).
Pharmacokinetic Blood Sampling: Blood samples are collected to assess telavancin plasma concentrations."
18065|NCT02391714|B3|Baseline|Total|Total of all reporting groups
18066|NCT02391714|B2|Baseline|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
18067|NCT02391714|B1|Baseline|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Oxygen: 100% oxygen via nasal mask."
18106|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
18107|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18424|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18068|NCT02391714|P2|Participant Flow|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
18113|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18981|NCT02375724|B2|Baseline|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
18069|NCT02391714|P1|Participant Flow|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Oxygen: 100% oxygen via nasal mask."
18070|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.
Chlorhexidine: For patients"
18071|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.
Chlorhexidine: For patients with allergy to iodine - 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol antiseptic"
18072|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.
Chlorhexidine: For patients"
18073|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.
Chlorhexidine: For patients with allergy to iodine - 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol antiseptic"
18074|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
18075|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Oxygen: 100% oxygen via nasal mask."
18076|NCT02391714|E2|Reported Event|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
18077|NCT02391714|E1|Reported Event|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.
If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.
IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
Oxygen: 100% oxygen via nasal mask."
18078|NCT02391311|B3|Baseline|Total|Total of all reporting groups
18079|NCT02391311|B2|Baseline|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
18080|NCT02391311|B1|Baseline|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
18081|NCT02391311|P2|Participant Flow|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
18082|NCT02391311|P1|Participant Flow|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
18083|NCT02391311|O2|Outcome|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
18084|NCT02391311|O1|Outcome|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
18085|NCT02391311|O2|Outcome|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
18086|NCT02391311|O1|Outcome|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
18433|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18087|NCT02391311|E2|Reported Event|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
18088|NCT02391311|E1|Reported Event|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
18089|NCT02391038|B1|Baseline|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
18090|NCT02391038|P3|Participant Flow|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18091|NCT02391038|P2|Participant Flow|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18092|NCT02391038|P1|Participant Flow|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18093|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18094|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, injection, intravenously on Day 1 of 3 week cycles of Phase 2, until disease progression or unacceptable toxicity. Dosage for this phase was determined from results of Phase 1 MTD/RP2D.
18095|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18096|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18097|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18098|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18099|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18100|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18101|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18102|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18103|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18104|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
18253|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
18109|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18110|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18111|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18114|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18115|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18116|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18117|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18118|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18119|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18120|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18121|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18122|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18123|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18124|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18125|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18126|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18127|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18128|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18129|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18130|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18131|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18132|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18133|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18134|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18135|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18136|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18137|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18425|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18138|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18139|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18140|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18141|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18142|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18143|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18144|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18145|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18146|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18147|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18148|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18149|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18150|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18151|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18152|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18153|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18154|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18155|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18156|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18157|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18158|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18159|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18160|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18161|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18162|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18163|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18164|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18165|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18166|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18426|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18167|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18168|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18169|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18170|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18171|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18172|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18173|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18174|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18175|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18176|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18177|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18178|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18179|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18180|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18181|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18182|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18183|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18184|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18185|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18186|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18187|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18188|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18189|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18190|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18191|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18192|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18193|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18194|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18195|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18427|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18196|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18197|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
18198|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
18199|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
19446|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
18200|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
18201|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
18202|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
18203|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
18204|NCT02391038|E1|Reported Event|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
18205|NCT02390167|B1|Baseline|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
18206|NCT02390167|P1|Participant Flow|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
18207|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18208|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18209|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18210|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18211|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18212|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18213|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18214|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18215|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18216|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18217|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18218|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18219|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
18220|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
18221|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary palm blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
18258|NCT02389881|O7|Outcome|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18434|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18222|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
18223|NCT02390167|E1|Reported Event|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
18224|NCT02389881|B8|Baseline|Total|Total of all reporting groups
18225|NCT02389881|B7|Baseline|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18226|NCT02389881|B6|Baseline|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
18227|NCT02389881|B5|Baseline|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
18228|NCT02389881|B4|Baseline|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
18229|NCT02389881|B3|Baseline|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18230|NCT02389881|B2|Baseline|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18231|NCT02389881|B1|Baseline|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18232|NCT02389881|P7|Participant Flow|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18233|NCT02389881|P6|Participant Flow|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
18234|NCT02389881|P5|Participant Flow|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
18235|NCT02389881|P4|Participant Flow|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
18236|NCT02389881|P3|Participant Flow|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18237|NCT02389881|P2|Participant Flow|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18238|NCT02389881|P1|Participant Flow|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18239|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
18240|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18241|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18242|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18243|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
18244|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
18245|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18246|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18247|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18248|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
18249|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
18250|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18251|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18252|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18254|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
18255|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18256|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18257|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18259|NCT02389881|O6|Outcome|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
18260|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
18261|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
18262|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18263|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18264|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18265|NCT02389881|O7|Outcome|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18266|NCT02389881|O6|Outcome|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
18267|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
18268|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
18269|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18270|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18271|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18272|NCT02389881|O7|Outcome|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18273|NCT02389881|O6|Outcome|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
18274|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
18275|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
18276|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18277|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18278|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18279|NCT02389881|E7|Reported Event|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18280|NCT02389881|E6|Reported Event|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
18281|NCT02389881|E5|Reported Event|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
18282|NCT02389881|E4|Reported Event|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
18283|NCT02389881|E3|Reported Event|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18284|NCT02389881|E2|Reported Event|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18285|NCT02389881|E1|Reported Event|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
18286|NCT02389452|B1|Baseline|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18328|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose"
21155|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
18287|NCT02389452|P1|Participant Flow|Synvisc-One|Single 6 mL intra-articular (IA) injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52 ) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18332|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days"
18435|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18288|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18289|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18290|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18291|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18292|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18293|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18294|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18295|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18296|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18297|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18298|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18299|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18300|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18329|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days"
18422|NCT02388347|P2|Participant Flow|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18301|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
18432|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18302|NCT02389452|E2|Reported Event|Synvisc-One: Local Adverse Event|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician’s discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain. Local adverse events were defined as any adverse event which occurred in the treated joint.
18303|NCT02389452|E1|Reported Event|Synvisc-One: Systemic Adverse Event|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician’s discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.Systemic adverse events were defined as any adverse event which occurred anywhere other than in the treated joint.
18304|NCT02389374|B4|Baseline|Total|Total of all reporting groups
18305|NCT02389374|B3|Baseline|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days"
18306|NCT02389374|B2|Baseline|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose"
18307|NCT02389374|B1|Baseline|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days"
18308|NCT02389374|P3|Participant Flow|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days"
18309|NCT02389374|P2|Participant Flow|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose"
18310|NCT02389374|P1|Participant Flow|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days"
18311|NCT02389374|O1|Outcome|All Malaria Patients|single Arm/Group for all participants
18312|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days"
18313|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose"
18314|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days"
18315|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days"
18316|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose"
18317|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days"
18318|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days"
18319|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose"
18320|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days"
18321|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days"
18322|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose"
18323|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days"
18324|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days"
18325|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose"
18326|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days"
18327|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days"
18387|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
18330|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days"
18331|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose"
18333|NCT02389374|O3|Outcome|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days"
18334|NCT02389374|O2|Outcome|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose"
18335|NCT02389374|O1|Outcome|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days"
18336|NCT02389374|E3|Reported Event|Artemether-lumefantrine Primaquine 14days|"mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days"
18337|NCT02389374|E2|Reported Event|Artemether-lumefantrine Primaquine 1day|"P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose"
18338|NCT02389374|E1|Reported Event|Chloroquine Primaquine 14days|"P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days"
18339|NCT02389361|B3|Baseline|Total|Total of all reporting groups
18340|NCT02389361|B2|Baseline|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol
Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
18341|NCT02389361|B1|Baseline|Group Z|"Postoperative Analgesia with Zaldiar
Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
18342|NCT02389361|P2|Participant Flow|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol
Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
18343|NCT02389361|P1|Participant Flow|Group Z|"Postoperative Analgesia with Zaldiar
Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
18344|NCT02389361|O2|Outcome|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol
Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
18345|NCT02389361|O1|Outcome|Group Z|"Postoperative Analgesia with Zaldiar
Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
18346|NCT02389361|E2|Reported Event|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol
Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
18347|NCT02389361|E1|Reported Event|Group Z|"Postoperative Analgesia with Zaldiar
Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
18348|NCT02389088|B1|Baseline|Phase I|9 PCOS women
18349|NCT02389088|P1|Participant Flow|Phase I - All Study Participants|"9 PCOS women will be studied. On study day one, r-FSH will be administered I.V. at a dose of 150 IU (FSH stimulation test). Blood samples will be obtained before and after FSH administration. After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month.
The FSH stimulation test will be repeated, as described above, at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function)."
18350|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
18351|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
18352|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
18353|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
18354|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
18355|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
18356|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
18357|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
18358|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
18359|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
18360|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
18361|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
18362|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
18363|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
18364|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
18365|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
18366|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
18367|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
18368|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
18369|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
18370|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
18371|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
18372|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
18373|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
18374|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
18375|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
18376|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
18377|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
18378|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
18379|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
18380|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
18381|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
18382|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
18383|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
18384|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
18385|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
18386|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
18390|NCT02389088|E2|Reported Event|Phase II|"Women that participated in Phase I will be studied again after a washout of 2 months. On study day one, an FSH stimulation test will be performed as described above.
After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month. Four weeks after administration of Lupron, each subject will receive Letrozole 5mg for 14 days. The FSH stimulation test will be repeated at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function).
Letrozole: In Phase II, letrozole, 5 mg/day, will be given for 14 days"
20328|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
18391|NCT02389088|E1|Reported Event|Phase I|"9 PCOS women will be studied. On study day one, r-FSH will be administered I.V. at a dose of 150 IU (FSH stimulation test). Blood samples will be obtained before and after FSH administration. After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month.
The FSH stimulation test will be repeated, as described above, at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function)."
18392|NCT02388815|B1|Baseline|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.
During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
18393|NCT02388815|P1|Participant Flow|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.
During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
18394|NCT02388815|O1|Outcome|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.
During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
18395|NCT02388815|E1|Reported Event|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.
During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
18396|NCT02388763|B1|Baseline|Overall|Habitual contact lenses worn first, followed by stenfilcon A contact lenses and narafilcon A contact lenses in Periods 1 and 2 as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
18397|NCT02388763|P2|Participant Flow|Habitual, 1DAVTE, MyDay|Habitual contact lenses worn first, followed by narafilcon A contact lenses in Period 1 and stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
18398|NCT02388763|P1|Participant Flow|Habitual, MyDay, 1DAVTE|Habitual contact lenses worn first, followed by stenfilcon A contact lenses in Period 1 and narafilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
18399|NCT02388763|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
18400|NCT02388763|O1|Outcome|MyDay|Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
18401|NCT02388763|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
18402|NCT02388763|O1|Outcome|MyDay|Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
18403|NCT02388763|E5|Reported Event|1DAVTE|Narafilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
18404|NCT02388763|E4|Reported Event|MyDay|Stenfilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
18405|NCT02388763|E3|Reported Event|Clariti 1-Day|Somofilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1
18406|NCT02388763|E2|Reported Event|Dailies Total 1|Delefilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1
18407|NCT02388763|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
18408|NCT02387268|B1|Baseline|CleanC|"Standard colonoscopy procedure using the CleanC system
CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
18409|NCT02387268|P1|Participant Flow|CleanC|"Standard colonoscopy procedure using the CleanC system
CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
18410|NCT02387268|O1|Outcome|CleanC|"Standard colonoscopy procedure using the CleanC system
CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
18411|NCT02387268|O1|Outcome|CleanC|"Standard colonoscopy procedure using the CleanC system
CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
18412|NCT02387268|E1|Reported Event|CleanC|"Standard colonoscopy procedure using the CleanC system
CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
18413|NCT02388347|B6|Baseline|Total|Total of all reporting groups
18414|NCT02388347|B5|Baseline|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18415|NCT02388347|B4|Baseline|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18416|NCT02388347|B3|Baseline|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18417|NCT02388347|B2|Baseline|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18418|NCT02388347|B1|Baseline|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
18419|NCT02388347|P5|Participant Flow|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18420|NCT02388347|P4|Participant Flow|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18421|NCT02388347|P3|Participant Flow|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
21156|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
18428|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
18429|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18430|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18431|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
41449|NCT02151994|E13|Reported Event|Placebo (MAD Period)|MAD period
18436|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18437|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18438|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18439|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18440|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18441|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18442|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18443|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18444|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18445|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18446|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18447|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18448|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18449|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18450|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18451|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18452|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18453|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18454|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18455|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18456|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18457|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18458|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18459|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18460|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18461|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
18462|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18463|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18464|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18465|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18466|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
18467|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18468|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18469|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18470|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18471|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
18472|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18473|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18474|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18475|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18476|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
18477|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18478|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18479|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18480|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18481|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
18482|NCT02388347|E5|Reported Event|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
18483|NCT02388347|E4|Reported Event|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
18484|NCT02388347|E3|Reported Event|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
18485|NCT02388347|E2|Reported Event|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
18486|NCT02388347|E1|Reported Event|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
18487|NCT02388191|B3|Baseline|Total|Total of all reporting groups
18488|NCT02388191|B2|Baseline|Placebo|"Placebo
Placebo tablet"
18489|NCT02388191|B1|Baseline|Naproxen Sodium|"550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
18490|NCT02388191|P2|Participant Flow|Placebo|"Placebo
Placebo tablet"
18491|NCT02388191|P1|Participant Flow|Naproxen Sodium|"550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
18492|NCT02388191|O2|Outcome|Placebo|"Placebo
Placebo tablet"
18493|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
18494|NCT02388191|O2|Outcome|Placebo|"Placebo
Placebo tablet"
18495|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
18496|NCT02388191|O2|Outcome|Placebo|"Placebo
Placebo tablet"
18497|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
18498|NCT02388191|O2|Outcome|Placebo|"Placebo
Placebo tablet"
18499|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
18500|NCT02388191|O2|Outcome|Placebo|"Placebo
Placebo tablet"
18501|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
18502|NCT02388191|E2|Reported Event|Placebo|"Placebo
Placebo tablet"
18503|NCT02388191|E1|Reported Event|Naproxen Sodium|"550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
18504|NCT02388074|B1|Baseline|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
18505|NCT02388074|P1|Participant Flow|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [i.e., cancer] cells (RFCs) from deep-lung sputum samples.
CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
18506|NCT02388074|O1|Outcome|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
18507|NCT02388074|E1|Reported Event|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [i.e., cancer] cells (RFCs) from deep-lung sputum samples.
CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
18508|NCT02387996|B1|Baseline|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
18509|NCT02387996|P1|Participant Flow|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
18510|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
18511|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
18512|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
18513|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
18514|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
18515|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
18516|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
18517|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
18518|NCT02387996|E1|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
18519|NCT02387983|B1|Baseline|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
18520|NCT02387983|P1|Participant Flow|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
18521|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
21157|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
18522|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
18523|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
18524|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
18525|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
18526|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
18527|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
18528|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
18529|NCT02387983|O1|Outcome|Posaconazole|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
18530|NCT02387983|E1|Reported Event|MK-5592|All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse group) underwent intensive and sparse PK sampling on Days 1 and 8; the next 45 participants (Sparse group) underwent PK sampling on Day 8 only.
18531|NCT02387801|B3|Baseline|Total|Total of all reporting groups
18532|NCT02387801|B2|Baseline|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
18533|NCT02387801|B1|Baseline|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
18534|NCT02387801|P2|Participant Flow|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44.
18535|NCT02387801|P1|Participant Flow|Ixekizumab Q2W|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
18536|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
18537|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
18538|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
18539|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
18540|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
18541|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
18542|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
18543|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
18544|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
18545|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
18546|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
18585|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18547|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
18548|NCT02387801|E4|Reported Event|Ixekizumab 80 mg Q4W Post-treatment|All participants receiving at least one dose of ixekizumab entered the post treatment follow-up period for a minimum of 12 weeks.
18549|NCT02387801|E3|Reported Event|Ixekizumab 80 mg Q4W Maintenance|After week 12 all participants are given 80 mg ixekizumab as a single SC injection once Q4W through week 44.
18550|NCT02387801|E2|Reported Event|Ixekizumab Q4W Induction Dosing Period|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
18590|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
41450|NCT02151994|E12|Reported Event|400 mg Fed (FE Period)|FE period
18551|NCT02387801|E1|Reported Event|Ixekizumab Q2W Induction Dosing Period|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
18552|NCT02387710|B1|Baseline|All Analyzed Participants|All patients who were randomized, completed both study nights and were included in the analysis
18553|NCT02387710|P2|Participant Flow|Placebo First, Tiagabine Second|Placebo-matching tiagabine administered at normal sleep timeon first study night, then a 1-week non-treatment, then tiagabine 12 mg administered at normal sleep time on second study night
18554|NCT02387710|P1|Participant Flow|Tiagabine First, Placebo Second|Tiagabine 12 mg administered at normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching tiagabine administered at normal sleep time on second study night.
18555|NCT02387710|O2|Outcome|Placebo|Placebo administered at sleep time on the first or the second study night
18556|NCT02387710|O1|Outcome|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or the second study night
18557|NCT02387710|O2|Outcome|Placebo|Placebo administered at sleep time on the first or second study night
18558|NCT02387710|O1|Outcome|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or second study night
18559|NCT02387710|O2|Outcome|Placebo|Placebo administered at sleep time on the first or second study night
18560|NCT02387710|O1|Outcome|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or second study night
18561|NCT02387710|E2|Reported Event|Placebo|Placebo administered at sleep time on the first or second study night
18562|NCT02387710|E1|Reported Event|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or second study night
18563|NCT02387580|B7|Baseline|Total|Total of all reporting groups
18564|NCT02387580|B6|Baseline|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
18565|NCT02387580|B5|Baseline|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18566|NCT02387580|B4|Baseline|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18567|NCT02387580|B3|Baseline|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18568|NCT02387580|B2|Baseline|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18569|NCT02387580|B1|Baseline|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18570|NCT02387580|P6|Participant Flow|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18571|NCT02387580|P5|Participant Flow|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18572|NCT02387580|P4|Participant Flow|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18573|NCT02387580|P3|Participant Flow|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18574|NCT02387580|P2|Participant Flow|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18575|NCT02387580|P1|Participant Flow|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18576|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18577|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18578|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18579|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18580|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18581|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18582|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18583|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18584|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18586|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18587|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18588|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18589|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
20329|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
18591|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18592|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18593|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18594|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
18595|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18596|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18597|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18598|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18599|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18600|NCT02387580|E6|Reported Event|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18601|NCT02387580|E5|Reported Event|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18602|NCT02387580|E4|Reported Event|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18603|NCT02387580|E3|Reported Event|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18604|NCT02387580|E2|Reported Event|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18605|NCT02387580|E1|Reported Event|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
18606|NCT02387554|B5|Baseline|Total|Total of all reporting groups
18607|NCT02387554|B4|Baseline|Sequence 4|Period 1 : ALC Period 2 : A Period 3 : C Period 4 : L
18608|NCT02387554|B3|Baseline|Sequence 3|Period 1 : C Period 2 : ALC Period 3 : L Period 4 : A
18609|NCT02387554|B2|Baseline|Sequence 2|Period 1 : L Period 2 : C Period 3 : A Period 4 : ALC
18610|NCT02387554|B1|Baseline|Sequence 1|Period 1 : A Period 2 : L Period 3 : ALC Period 4 : C
18611|NCT02387554|P4|Participant Flow|Sequence 4|Period 1 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 2 : A (Amlodipine 10mg PO single dose) Period 3 : C (Chlorthalidone 25mg PO single dose) Period 4 : L (Losartan 100mg PO single dose)
18612|NCT02387554|P3|Participant Flow|Sequence 3|Period 1 : C (Chlorthalidone 25mg PO single dose) Period 2 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 3 : L (Losartan 100mg PO single dose) Period 4 : A (Amlodipine 10mg PO single dose)
18613|NCT02387554|P2|Participant Flow|Sequence 2|Period 1 : L (Losartan 100mg PO single dose) Period 2 : C (Chlorthalidone 25mg PO single dose) Period 3 : A (Amlodipine 10mg PO single dose) Period 4 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose)
18614|NCT02387554|P1|Participant Flow|Sequence 1|Period 1 : A (Amlodipine 10mg PO single dose) Period 2 : L (Losartan 100mg PO single dose) Period 3 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 4 : C (Chlorthalidone 25mg PO single dose)
18615|NCT02387554|O4|Outcome|EXP3174|EXP3174(losartan active metabolite) ratio in single or combination
18616|NCT02387554|O3|Outcome|HGP1405|HGP1405(chlorthalidone) ratio in single or combination
18617|NCT02387554|O2|Outcome|HGP0608|HGP0608(losartan) ratio in single or combination
18618|NCT02387554|O1|Outcome|HGP0904|HGP0904(amlodipine) ratio in single or combination
18619|NCT02387554|E4|Reported Event|HGP0904+HGP0608+HGP1405|"amlodipine + losartan + chlorthalidone
HGP0904
HGP0608
HGP1405"
18620|NCT02387554|E3|Reported Event|HGP1405|"chlorthalidone
HGP1405"
18621|NCT02387554|E2|Reported Event|HGP0608|"losartan
HGP0608"
18622|NCT02387554|E1|Reported Event|HGP0904|"amlodipine
HGP0904"
18623|NCT02387502|B4|Baseline|Total|Total of all reporting groups
18624|NCT02387502|B3|Baseline|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
18625|NCT02387502|B2|Baseline|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
18673|NCT02384070|E3|Reported Event|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
18626|NCT02387502|B1|Baseline|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
18627|NCT02387502|P3|Participant Flow|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
18628|NCT02387502|P2|Participant Flow|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
18629|NCT02387502|P1|Participant Flow|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
18630|NCT02387502|O3|Outcome|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
18631|NCT02387502|O2|Outcome|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
18632|NCT02387502|O1|Outcome|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
18633|NCT02387502|E3|Reported Event|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
18634|NCT02387502|E2|Reported Event|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
18702|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
18671|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
18672|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
41451|NCT02151994|E11|Reported Event|400 mg Fasted (FE Period)|FE period
18635|NCT02387502|E1|Reported Event|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
18636|NCT02384538|B3|Baseline|Total|Total of all reporting groups
18637|NCT02384538|B2|Baseline|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
18638|NCT02384538|B1|Baseline|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
18639|NCT02384538|P2|Participant Flow|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
18640|NCT02384538|P1|Participant Flow|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
18641|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
18642|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
18643|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
18644|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
18645|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
18646|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
18647|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
18648|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
18649|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
18650|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
18651|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
18652|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
18653|NCT02384538|O2|Outcome|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
18654|NCT02384538|O1|Outcome|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
18655|NCT02384538|E2|Reported Event|ABT-981|ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
18656|NCT02384538|E1|Reported Event|Placebo|Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
18657|NCT02384070|B4|Baseline|Total|Total of all reporting groups
18658|NCT02384070|B3|Baseline|Group 3: Upstream Aspirin Plus Bivalirudin|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
18659|NCT02384070|B2|Baseline|Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
18660|NCT02384070|B1|Baseline|Group 1: Upstream Aspirin + Clopidrogel|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
18661|NCT02384070|P3|Participant Flow|Group 3: Upstream Aspirin Plus Bivalirudin|Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
18662|NCT02384070|P2|Participant Flow|Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin|Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
18663|NCT02384070|P1|Participant Flow|Group 1: Upstream Aspirin + Clopidrogel|Received upstream aspirin plus clopidogrel with no intra-procedural anticoagulation for the FFR calculation with a saline bolus and drip used for placebo anticoagulation during the procedure to blind the operator
18664|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
18665|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
18666|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
18667|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
18668|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
18669|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
18670|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
18701|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
18674|NCT02384070|E2|Reported Event|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
18675|NCT02384070|E1|Reported Event|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
18676|NCT02383862|B3|Baseline|Total|Total of all reporting groups
18677|NCT02383862|B2|Baseline|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
18678|NCT02383862|B1|Baseline|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
18679|NCT02383862|P2|Participant Flow|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
18680|NCT02383862|P1|Participant Flow|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
18681|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
18682|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
18683|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
18684|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
18685|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
18686|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
18687|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
18688|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
18689|NCT02383862|O1|Outcome|Follow up Sample Responding to SF-36 Vitality Scale (n=256)|Of the 300 participants invited to complete the 3-month follow up assessment, 256 participants responded to items on the SF-36 vitality scale. No group comparisons were made.
18690|NCT02383862|O1|Outcome|Follow up Sample Responding to PHQ-2 (n=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on the PHQ-2. No group comparisons were made.
18691|NCT02383862|O1|Outcome|Follow up Sample Responding to GAD-2 (n=256)|Of the 300 participants invited to complete the 3-month follow up assessment, 256 participants responded to items on the GAD-2. No group comparisons were made.
18692|NCT02383862|O1|Outcome|Follow up Sample Responding to PEG (n=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on PEG. No group comparisons were made.
18693|NCT02383862|O1|Outcome|Follow up Sample Responding to PIRS-2 (N=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on the PIRS-2. No group comparisons were made.
18694|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
18695|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
18696|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
18697|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
18698|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
18699|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
18700|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
21158|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
18703|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
18704|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
18705|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
18706|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
18707|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
18708|NCT02383862|E2|Reported Event|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
18709|NCT02383862|E1|Reported Event|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
18710|NCT02383719|B1|Baseline|Oro-nasal Mask|Oro-nasal Mask
18711|NCT02383719|P1|Participant Flow|Oro-nasal Mask|Oro-nasal Mask
18712|NCT02383719|O1|Outcome|Oro-nasal Mask|All patients in this group received the experimental oro-nasal mask for evaluation of use. Patient's received non-invasive ventilation were switched to this mask upone study initiation.
18713|NCT02383719|E1|Reported Event|Oro-nasal Mask|Oro-nasal Mask
18714|NCT02383420|B4|Baseline|Total|Total of all reporting groups
18715|NCT02383420|B3|Baseline|Predicate & Invest.-Cadavers GOS & CsI|Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
18716|NCT02383420|B2|Baseline|Predicate & Invest.-CsI|Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
18717|NCT02383420|B1|Baseline|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
18718|NCT02383420|P3|Participant Flow|Predicate & Investigational-Cadavers|Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
18719|NCT02383420|P2|Participant Flow|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
18720|NCT02383420|P1|Participant Flow|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
18721|NCT02383420|O1|Outcome|Image Pair Preference|Preference for predicate detector DRX-1 image versus preference for investigational DRX-PRO 3543/C (GOS & CsI) and vice versa.
18722|NCT02383420|O2|Outcome|Investigational|DRX PRO 3543/C (GOS & CsI) Detectors, Live Subjects & Cadavers
18723|NCT02383420|O1|Outcome|Predicate|DRX-1 Detector, Live Subjects and Cadavers
18724|NCT02383420|E3|Reported Event|Predicate & Invest.-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detectors.
18725|NCT02383420|E2|Reported Event|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
18726|NCT02383420|E1|Reported Event|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
18727|NCT02382913|B11|Baseline|Total|Total of all reporting groups
18728|NCT02382913|B10|Baseline|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18729|NCT02382913|B9|Baseline|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18730|NCT02382913|B8|Baseline|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18731|NCT02382913|B7|Baseline|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18732|NCT02382913|B6|Baseline|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18733|NCT02382913|B5|Baseline|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18734|NCT02382913|B4|Baseline|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18735|NCT02382913|B3|Baseline|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
21159|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
18736|NCT02382913|B2|Baseline|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18737|NCT02382913|B1|Baseline|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18738|NCT02382913|P10|Participant Flow|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18739|NCT02382913|P9|Participant Flow|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18740|NCT02382913|P8|Participant Flow|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18741|NCT02382913|P7|Participant Flow|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18742|NCT02382913|P6|Participant Flow|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18743|NCT02382913|P5|Participant Flow|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18744|NCT02382913|P4|Participant Flow|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18745|NCT02382913|P3|Participant Flow|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18746|NCT02382913|P2|Participant Flow|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18747|NCT02382913|P1|Participant Flow|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18748|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18749|NCT02382913|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18750|NCT02382913|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18751|NCT02382913|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18752|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18753|NCT02382913|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18754|NCT02382913|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18755|NCT02382913|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18756|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18757|NCT02382913|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18758|NCT02382913|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18861|NCT02381288|O3|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
18759|NCT02382913|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18760|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18791|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
41452|NCT02151994|E10|Reported Event|2400 mg (SAD)|SAD period
18761|NCT02382913|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18762|NCT02382913|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18763|NCT02382913|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18764|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18765|NCT02382913|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18766|NCT02382913|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18767|NCT02382913|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18768|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18769|NCT02382913|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18770|NCT02382913|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18771|NCT02382913|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18772|NCT02382913|E10|Reported Event|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18773|NCT02382913|E9|Reported Event|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18774|NCT02382913|E8|Reported Event|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18775|NCT02382913|E7|Reported Event|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18776|NCT02382913|E6|Reported Event|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18777|NCT02382913|E5|Reported Event|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18778|NCT02382913|E4|Reported Event|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18779|NCT02382913|E3|Reported Event|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18780|NCT02382913|E2|Reported Event|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18781|NCT02382913|E1|Reported Event|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
18782|NCT02382640|B5|Baseline|Total|Total of all reporting groups
21160|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
18792|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
18793|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
18783|NCT02382640|B4|Baseline|Regimen B, Then C, Then A, Then D|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days).
18784|NCT02382640|B3|Baseline|Regimen C, Then D, Then B, Then A|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days).
18785|NCT02382640|B2|Baseline|Regimen D, Then A, Then C, Then B|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]).
18786|NCT02382640|B1|Baseline|Regimen A, Then B, Then D, Then C|Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days).
18787|NCT02382640|P4|Participant Flow|Regimen B, Then C, Then A, Then D|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days).
18788|NCT02382640|P3|Participant Flow|Regimen C, Then D, Then B, Then A|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days).
18789|NCT02382640|P2|Participant Flow|Regimen D, Then A, Then C, Then B|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]).
18790|NCT02382640|P1|Participant Flow|Regimen A, Then B, Then D, Then C|Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days).
18794|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
18795|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
18796|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
18797|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
18798|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
18799|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
18800|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
18801|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
18802|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
18803|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
18804|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
18805|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
18806|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
18807|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
18808|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
18809|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
18810|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
18811|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
18812|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
18813|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
18814|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
18815|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
18816|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
18817|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
18818|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
18819|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
18862|NCT02381288|O2|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
18820|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
18821|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
18935|NCT02379637|P1|Participant Flow|A N-acetylcysteine|"N-acetylcysteine
N-acetylcysteine, capsules, 800 mg 3 times daily"
18822|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
18823|NCT02382640|E4|Reported Event|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
18824|NCT02382640|E3|Reported Event|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
18825|NCT02382640|E2|Reported Event|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
18826|NCT02382640|E1|Reported Event|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
18827|NCT02382133|B1|Baseline|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor
Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
18828|NCT02382133|P1|Participant Flow|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor
Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
18829|NCT02382133|O1|Outcome|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor
Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
18830|NCT02382133|O1|Outcome|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor
Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
18831|NCT02382133|E1|Reported Event|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor
Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
18832|NCT02381678|B1|Baseline|All Patients Enrolled in Study|The whole group included 225 enrolled subjects. All 225 subjects included in the FAS(Full Analysis Set).
18833|NCT02381678|P3|Participant Flow|Age Group Above 70 Years Old|32 subjects implanted Perimount Heart Valve when the age was above 70
18834|NCT02381678|P2|Participant Flow|Age Group Between 60 and 70 Years Old|139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70)
18835|NCT02381678|P1|Participant Flow|Age Group Under 60 Years Old|54 subjects implanted Perimount Heart Valve when the age was under 60.
18836|NCT02381678|O1|Outcome|One-arm Group Included All Enrolled Subjects|This group included total 225 enrolled participants
18837|NCT02381678|E3|Reported Event|Age Group Above 70 Years Old|32 subjects implanted Perimount Heart Valve when the age was above 70
18838|NCT02381678|E2|Reported Event|Age Group Between 60 and 70 Years Old|139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70)
18839|NCT02381678|E1|Reported Event|Age Group Under 60 Years Old|54 subjects implanted Perimount Heart Valve when the age was under 60.
18840|NCT02381418|B1|Baseline|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
18841|NCT02381418|P1|Participant Flow|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "
18842|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
18843|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 
Trivalent influenza subunit vaccine Influvac: 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
18844|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
18845|NCT02381418|E1|Reported Event|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
18846|NCT02381288|B5|Baseline|Total|Total of all reporting groups
18847|NCT02381288|B4|Baseline|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
18848|NCT02381288|B3|Baseline|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
18849|NCT02381288|B2|Baseline|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
18850|NCT02381288|B1|Baseline|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
18851|NCT02381288|P4|Participant Flow|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
18852|NCT02381288|P3|Participant Flow|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
18853|NCT02381288|P2|Participant Flow|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
18854|NCT02381288|P1|Participant Flow|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
18855|NCT02381288|O3|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
18856|NCT02381288|O2|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
18857|NCT02381288|O1|Outcome|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
18858|NCT02381288|O3|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
18859|NCT02381288|O2|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
18860|NCT02381288|O1|Outcome|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
18863|NCT02381288|O1|Outcome|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
18864|NCT02381288|O4|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
18865|NCT02381288|O3|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
18866|NCT02381288|O2|Outcome|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
18867|NCT02381288|O1|Outcome|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
18868|NCT02381288|O4|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
18869|NCT02381288|O3|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
18870|NCT02381288|O2|Outcome|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
18871|NCT02381288|O1|Outcome|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
18872|NCT02381288|O4|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
18873|NCT02381288|O3|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
18874|NCT02381288|O2|Outcome|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
18875|NCT02381288|O1|Outcome|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
18876|NCT02381288|E4|Reported Event|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
18877|NCT02381288|E3|Reported Event|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
18878|NCT02381288|E2|Reported Event|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
18879|NCT02381288|E1|Reported Event|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
18880|NCT02380742|B3|Baseline|Total|Total of all reporting groups
18881|NCT02380742|B2|Baseline|Placebo|"4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18882|NCT02380742|B1|Baseline|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18883|NCT02380742|P2|Participant Flow|Placebo|"4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18884|NCT02380742|P1|Participant Flow|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18885|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18886|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18927|NCT02380248|P1|Participant Flow|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID (4 times/day) in each eye for 90 days
18928|NCT02380248|O1|Outcome|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
18929|NCT02380248|E2|Reported Event|Systane|All subjects exposed to study treatment
18930|NCT02380248|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
18936|NCT02379637|O2|Outcome|B Placebo|"Placebo
Placebo"
18937|NCT02379637|O1|Outcome|A N-acetylcysteine|"N-acetylcysteine
N-acetylcysteine"
18938|NCT02379637|O2|Outcome|B Placebo|"Placebo
Placebo"
18939|NCT02379637|O1|Outcome|A N-acetylcysteine|"N-acetylcysteine
N-acetylcysteine"
18940|NCT02379637|E2|Reported Event|B Placebo|"Placebo
Placebo"
18941|NCT02379637|E1|Reported Event|A N-acetylcysteine|"N-acetylcysteine
N-acetylcysteine"
18887|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18888|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18889|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18890|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18891|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18892|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18893|NCT02380742|E2|Reported Event|Placebo|"4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18894|NCT02380742|E1|Reported Event|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
18895|NCT02380287|B9|Baseline|Total|Total of all reporting groups
18896|NCT02380287|B8|Baseline|Cohort no.8|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
18897|NCT02380287|B7|Baseline|Cohort no.7|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
18898|NCT02380287|B6|Baseline|Cohort no.6|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
18899|NCT02380287|B5|Baseline|Cohort no.5|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
18900|NCT02380287|B4|Baseline|Cohort no.4|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
18901|NCT02380287|B3|Baseline|Cohort no.3|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
18902|NCT02380287|B2|Baseline|Cohort no.2|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
18903|NCT02380287|B1|Baseline|Cohort no.1|This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
18904|NCT02380287|P8|Participant Flow|Cohort no.8|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level.
humanized monoclonal antibody against human IL-17"
18931|NCT02379637|B3|Baseline|Total|Total of all reporting groups
18905|NCT02380287|P7|Participant Flow|Cohort no.7|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 8 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 8.
humanized monoclonal antibody against human IL-17"
18906|NCT02380287|P6|Participant Flow|Cohort no.6|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 7 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 7.
humanized monoclonal antibody against human IL-17"
18907|NCT02380287|P5|Participant Flow|Cohort no.5|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 6 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 6.
humanized monoclonal antibody against human IL-17"
18908|NCT02380287|P4|Participant Flow|Cohort no.4|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 5 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 5.
humanized monoclonal antibody against human IL-17"
18909|NCT02380287|P3|Participant Flow|Cohort no.3|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 4 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 4.
humanized monoclonal antibody against human IL-17"
18910|NCT02380287|P2|Participant Flow|Cohort no.2|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 3 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 3.
humanized monoclonal antibody against human IL-17"
18911|NCT02380287|P1|Participant Flow|Cohort no.1|"This cohort includes just one subject who will receive the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously. If the dose limitating toxicity occurs within the first seven days after injection the study will be stopped. If there is no DLT within mentioned above period then Cohort no.2 is included.
humanized monoclonal antibody against human IL-17"
18912|NCT02380287|O1|Outcome|BCD-085|This cohort includes subjects who received any dose of BCD-085 subcutaneously.
18913|NCT02380287|E8|Reported Event|Cohort no.8|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
18914|NCT02380287|E7|Reported Event|Cohort no.7|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
18915|NCT02380287|E6|Reported Event|Cohort no.6|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
18916|NCT02380287|E5|Reported Event|Cohort no.5|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
18917|NCT02380287|E4|Reported Event|Cohort no.4|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
18918|NCT02380287|E3|Reported Event|Cohort no.3|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
18919|NCT02380287|E2|Reported Event|Cohort no.2|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
18920|NCT02380287|E1|Reported Event|Cohort no.1|This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
18921|NCT02380261|B1|Baseline|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
18922|NCT02380261|P1|Participant Flow|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
18923|NCT02380261|O1|Outcome|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
18924|NCT02380261|O1|Outcome|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
18925|NCT02380261|E1|Reported Event|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
18926|NCT02380248|B1|Baseline|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
18932|NCT02379637|B2|Baseline|B Placebo|"Placebo
Placebo"
21161|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
18942|NCT02378506|B1|Baseline|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18943|NCT02378506|P1|Participant Flow|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18944|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18945|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18946|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18947|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18948|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18949|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18950|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18951|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18952|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18953|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18954|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18955|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18956|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18957|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18958|NCT02378506|E1|Reported Event|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
18959|NCT02376998|B1|Baseline|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta.
18960|NCT02376998|P1|Participant Flow|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta.
18961|NCT02376998|O1|Outcome|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta. Mortality 0%
18962|NCT02376998|E1|Reported Event|Valiant™ Endoluminal Procedure|"Data from early and long term complications following endoluminal stent-graft placement for thoracic endovascular aortic repair (TEVAR) procedure (Valiant™ endoluminal procedure) will be collected.
Valiant™ endoluminal procedure: Thoracic endovascular aortic repair with Endoluminal stent-graft placement (Valiant™ endoluminal stent-graft systems (Medtronic Inc., Santa Rosa, CA, USA) will be performed as follows:
The diameter of the stent graft will be calculated from the largest diameter of the proximal/distal neck with an oversizing factor of 10-20%. The procedures will be done with local or general anaesthesia in case of unstable pre-operative hemodynamic conditions.
After the procedure will be completed, a digital subtraction angiography and echocardiography with color-flow mapping were performed to verify the correct positioning of the stent and to detect any primary endoleak."
18963|NCT02376530|B5|Baseline|Total|Total of all reporting groups
18964|NCT02376530|B4|Baseline|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
18965|NCT02376530|B3|Baseline|Price Change|Price changes will be present during shopping session.
18966|NCT02376530|B2|Baseline|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
18967|NCT02376530|B1|Baseline|Usual Shopping|No change in condition.
18968|NCT02376530|P4|Participant Flow|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
18969|NCT02376530|P3|Participant Flow|Price Change|Price changes will be present during shopping session.
18970|NCT02376530|P2|Participant Flow|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
18971|NCT02376530|P1|Participant Flow|Usual Shopping|No change in condition.
18972|NCT02376530|O4|Outcome|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
18973|NCT02376530|O3|Outcome|Price Change|Price changes will be present during shopping session.
18974|NCT02376530|O2|Outcome|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
18976|NCT02376530|E4|Reported Event|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
18977|NCT02376530|E3|Reported Event|Price Change|Price changes will be present during shopping session.
18978|NCT02376530|E2|Reported Event|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
18979|NCT02376530|E1|Reported Event|Usual Shopping|No change in condition.
18980|NCT02375724|B3|Baseline|Total|Total of all reporting groups
41453|NCT02151994|E9|Reported Event|1600 mg (SAD)|SAD period
18982|NCT02375724|B1|Baseline|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
18983|NCT02375724|P2|Participant Flow|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
18984|NCT02375724|P1|Participant Flow|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
18985|NCT02375724|O2|Outcome|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
18986|NCT02375724|O1|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
18987|NCT02375724|O2|Outcome|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
18988|NCT02375724|O1|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
18989|NCT02375724|O2|Outcome|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
18990|NCT02375724|O1|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
18991|NCT02375724|E2|Reported Event|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
18992|NCT02375724|E1|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
18993|NCT02375373|B1|Baseline|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)
Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.
Fecal samples collected monthly."
18994|NCT02375373|P1|Participant Flow|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)
Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.
Fecal samples collected monthly."
18995|NCT02375373|O1|Outcome|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)
Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.
Fecal samples collected monthly."
18996|NCT02375373|E1|Reported Event|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)
Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.
Fecal samples collected monthly."
18997|NCT02375347|B1|Baseline|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)
Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.
Stool Samples collected at Day 1, Day 9, and Day 14."
18998|NCT02375347|P1|Participant Flow|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)
Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.
Stool Samples collected at Day 1, Day 9, and Day 14."
18999|NCT02375347|O1|Outcome|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)
Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.
Stool Samples collected at Day 1, Day 9, and Day 14."
19000|NCT02375347|E1|Reported Event|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)
Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.
Stool Samples collected at Day 1, Day 9, and Day 14."
19001|NCT02374398|B5|Baseline|Total|Total of all reporting groups
19002|NCT02374398|B4|Baseline|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery"
19003|NCT02374398|B3|Baseline|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions"
19004|NCT02374398|B2|Baseline|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts
Aquamantys System: see arm/group descriptions"
19005|NCT02374398|B1|Baseline|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions"
19006|NCT02374398|P4|Participant Flow|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery"
19026|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery"
19051|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
21162|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
19007|NCT02374398|P3|Participant Flow|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions"
19481|NCT02370602|P1|Participant Flow|[^11C]T-773 Only|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
19008|NCT02374398|P2|Participant Flow|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts
Aquamantys System: see arm/group descriptions"
19009|NCT02374398|P1|Participant Flow|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions"
19010|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery"
19011|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions"
19012|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts
Aquamantys System: see arm/group descriptions"
19013|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions"
19014|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control: Standard Electro-cautery and Saline"
19015|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions"
19016|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts
Aquamantys System: see arm/group descriptions"
19017|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions"
19018|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery"
19019|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions"
19020|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts
Aquamantys System: see arm/group descriptions"
19021|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions"
19022|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery"
19023|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions"
19024|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts
Aquamantys System: see arm/group descriptions"
19025|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions"
19027|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions"
19028|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts
Aquamantys System: see arm/group descriptions"
19029|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions"
19030|NCT02374398|E4|Reported Event|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery"
19031|NCT02374398|E3|Reported Event|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions"
19032|NCT02374398|E2|Reported Event|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts
Aquamantys System: see arm/group descriptions"
19033|NCT02374398|E1|Reported Event|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions"
19034|NCT02374346|B1|Baseline|Elective Surgery Patients|All adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ear-nose-throat (ENT) and vascular procedures.
19035|NCT02374346|P1|Participant Flow|Elective Surgery Patients|A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
19036|NCT02374346|O2|Outcome|Postoperative Headache Patients Without Headache History|Factors for developing postoperative headache in patients without previous history of headache.
19037|NCT02374346|O1|Outcome|Postoperative Headache in the Total Sample|Factors for developing postoperative headache in the total number of participants
19038|NCT02374346|O1|Outcome|Elective Surgery Patients (Total Sample)|postoperative headache in elective surgery patients
19039|NCT02374346|E1|Reported Event|Elective Surgery Patients|A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
19040|NCT02374164|B4|Baseline|Total|Total of all reporting groups
19041|NCT02374164|B3|Baseline|Treatment Sequence CAB|Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
19042|NCT02374164|B2|Baseline|Treatment Sequence BCA|Febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal.
19043|NCT02374164|B1|Baseline|Treatment Sequence ABC|Febuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
19044|NCT02374164|P3|Participant Flow|Treatment Sequence CAB|Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
19045|NCT02374164|P2|Participant Flow|Treatment Sequence BCA|Febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal.
19046|NCT02374164|P1|Participant Flow|Treatment Sequence ABC|Febuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
19047|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
19048|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
19049|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
19050|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
19052|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
19053|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
19054|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
19055|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
19056|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
19057|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
19058|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
19059|NCT02374164|E3|Reported Event|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
19060|NCT02374164|E2|Reported Event|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
19061|NCT02374164|E1|Reported Event|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
19062|NCT02372344|B1|Baseline|AZD0585|All subjects received a single oral dose of 4 g AZD0585 on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions. Each dose was administered on Day 1 of each separate treatment period: Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4.
19063|NCT02372344|P3|Participant Flow|Sequence CAB|"Subjects randomized to treatment sequence CAB: C=after meal / A=fasting / B=before meal.
Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
19064|NCT02372344|P2|Participant Flow|Sequence BCA|"Subjects randomized to treatment sequence BCA: B=before meal / C=after meal / A=fasting.
Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
19065|NCT02372344|P1|Participant Flow|Sequence ABC|"Subjects randomized to treatment sequence ABC: A=fasting / B=before meal / C=after meal.
Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
19066|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
19067|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
19068|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
19069|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
19070|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
19071|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
19072|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
19073|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
19074|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
19075|NCT02372344|E3|Reported Event|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
19076|NCT02372344|E2|Reported Event|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
19077|NCT02372344|E1|Reported Event|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
19078|NCT02372097|B3|Baseline|Total|Total of all reporting groups
19079|NCT02372097|B2|Baseline|SYR-472 50 mg + SYR-472 25 mg|SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days).
19080|NCT02372097|B1|Baseline|SYR-472 25 mg + SYR-472 50 mg|SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days).
19081|NCT02372097|P2|Participant Flow|SYR-472 50 mg + SYR-472 25 mg|SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days).
19731|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19082|NCT02372097|P1|Participant Flow|SYR-472 25 mg + SYR-472 50 mg|SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days).
19083|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19084|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19085|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19086|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19087|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19088|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19089|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19090|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19091|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19092|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19093|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19094|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19095|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19096|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19097|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19098|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19099|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19100|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19101|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19102|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19103|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19104|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19105|NCT02372097|E2|Reported Event|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19106|NCT02372097|E1|Reported Event|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
19107|NCT02372071|B1|Baseline|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
19108|NCT02372071|P1|Participant Flow|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
19109|NCT02372071|O2|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age) measured routinely for total serum bilirubin
19110|NCT02372071|O1|Outcome|BiliCare TcB Average|"The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip.
This is the average of both devices"
19111|NCT02372071|E1|Reported Event|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
19112|NCT02372058|B1|Baseline|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
19113|NCT02372058|P1|Participant Flow|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
19114|NCT02372058|O3|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.
19115|NCT02372058|O2|Outcome|JM103 TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device
19116|NCT02372058|O1|Outcome|BiliCare TcB Average|"The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip.
This is the average of both devices"
19117|NCT02372058|E1|Reported Event|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
19157|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19118|NCT02371876|B1|Baseline|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
19119|NCT02371876|P1|Participant Flow|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
19120|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
19121|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
19122|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
19123|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
ONYX PLUS Investigational Blood Glucose Monitoring System: Study staff tested subject venous blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. BG results were compared to reference method results obtained from subject venous plasma."
19124|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
ONYX PLUS Investigational Blood Glucose Monitoring System: Study staff tested subject fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
19125|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary palm blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
19126|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
19127|NCT02371876|E1|Reported Event|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.
ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
19128|NCT02371850|B1|Baseline|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
19129|NCT02371850|P1|Participant Flow|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
19130|NCT02371850|O1|Outcome|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
19131|NCT02371850|O1|Outcome|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
20313|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
19445|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19132|NCT02371850|E1|Reported Event|Nicoderm Patch First, Then Aveva Patch|Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
19133|NCT02371759|B9|Baseline|Total|Total of all reporting groups
19134|NCT02371759|B8|Baseline|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19135|NCT02371759|B7|Baseline|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19136|NCT02371759|B6|Baseline|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19137|NCT02371759|B5|Baseline|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19138|NCT02371759|B4|Baseline|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19139|NCT02371759|B3|Baseline|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19140|NCT02371759|B2|Baseline|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19141|NCT02371759|B1|Baseline|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19142|NCT02371759|P8|Participant Flow|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19143|NCT02371759|P7|Participant Flow|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19144|NCT02371759|P6|Participant Flow|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19145|NCT02371759|P5|Participant Flow|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19146|NCT02371759|P4|Participant Flow|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19147|NCT02371759|P3|Participant Flow|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19148|NCT02371759|P2|Participant Flow|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19149|NCT02371759|P1|Participant Flow|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19150|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19151|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19152|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19153|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19154|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19155|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19156|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19732|NCT02369796|E5|Reported Event|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19158|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19159|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19160|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19161|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19162|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19163|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19164|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19165|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19166|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19167|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19168|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19169|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19170|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19171|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19172|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19173|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19174|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19175|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19176|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19177|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19178|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19179|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19180|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19181|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19733|NCT02369796|E4|Reported Event|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19182|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19183|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19184|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19185|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19186|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19187|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19188|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19189|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19190|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19191|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19192|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19193|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19194|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19195|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19196|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19197|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19198|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19199|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19200|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19201|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19202|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19203|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19204|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19205|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19206|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19734|NCT02369796|E3|Reported Event|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19207|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19208|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19209|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19210|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19211|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19212|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19213|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19214|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19215|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19216|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19217|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19218|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19219|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19220|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19221|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19222|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19223|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19224|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19225|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19226|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19227|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19228|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19229|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19230|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19231|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19735|NCT02369796|E2|Reported Event|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19232|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19233|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19234|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19235|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19236|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19237|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19238|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19239|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19240|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19241|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19242|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19243|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19244|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19245|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19246|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19247|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19248|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19249|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19250|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19251|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19252|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19253|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19254|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19255|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19256|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19736|NCT02369796|E1|Reported Event|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19257|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19258|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19259|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19260|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19261|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19262|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19263|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19264|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19265|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19266|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19267|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19268|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19269|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19270|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19271|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19272|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19273|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19274|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19275|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19276|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19277|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19278|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19279|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19280|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19281|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19737|NCT02369510|B4|Baseline|Total|Total of all reporting groups
21163|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
19282|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19283|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19284|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19285|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19286|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19287|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19288|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19289|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19290|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19291|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19292|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19293|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19294|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19295|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19296|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19297|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19298|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19299|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19300|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19301|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19302|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19303|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19304|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19305|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19306|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19738|NCT02369510|B3|Baseline|No Epinephrine|"0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
19307|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19308|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19309|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19310|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19311|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19312|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19313|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19314|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19315|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19316|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19317|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19318|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19319|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19320|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19321|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19322|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19323|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19324|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19325|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19326|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19327|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19328|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19329|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19330|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19331|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
20314|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
19332|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19333|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19334|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19335|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19336|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19337|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19338|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19339|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19340|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19341|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19342|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19343|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19344|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19345|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19346|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19347|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19348|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19349|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19350|NCT02371759|E8|Reported Event|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19351|NCT02371759|E7|Reported Event|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19352|NCT02371759|E6|Reported Event|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19353|NCT02371759|E5|Reported Event|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19354|NCT02371759|E4|Reported Event|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19355|NCT02371759|E3|Reported Event|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
19356|NCT02371759|E2|Reported Event|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
20315|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
19357|NCT02371759|E1|Reported Event|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
19358|NCT02370914|B1|Baseline|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .
Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
19359|NCT02370914|P1|Participant Flow|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .
Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
19360|NCT02370914|O1|Outcome|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .
Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
19361|NCT02370914|E1|Reported Event|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .
Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
19362|NCT02370667|B4|Baseline|Total|Total of all reporting groups
19363|NCT02370667|B3|Baseline|Meditation Control (M)|"The participants in this arm will be asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. This will take place at an alternate yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group will be offered a free exercise pass following completion of the study.
Meditation Control (M): A meditation program acting as a control will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
19364|NCT02370667|B2|Baseline|Traditional Exercise (TE)|"The participants in this arm will be prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program will include 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants will be asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers will be available during all class times for program completion and progression.
Traditional Exercise (TE): A traditional exercise program for people with knee OA will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
19365|NCT02370667|B1|Baseline|Biomechanical Exercise (BE)|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times will be offered per week. These classes will include a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes will include clinical mobility; muscle and fat volumes, and cartilage morphology using MRI; pain; isometric leg strength; cardiovascular fitness; and gait analysis.
Biomechanical Exercise (BE): A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
19366|NCT02370667|P3|Participant Flow|Meditation Control (M)|"The participants in this arm will be asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. This will take place at an alternate yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group will be offered a free exercise pass following completion of the study.
Meditation Control (M): A meditation program acting as a control will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
19367|NCT02370667|P2|Participant Flow|Traditional Exercise (TE)|"The participants in this arm will be prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program will include 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants will be asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers will be available during all class times for program completion and progression.
Traditional Exercise (TE): A traditional exercise program for people with knee OA will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
19368|NCT02370667|P1|Participant Flow|Biomechanical Exercise (BE)|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times will be offered per week. These classes will include a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes will include clinical mobility; muscle and fat volumes, and cartilage morphology using MRI; pain; isometric leg strength; cardiovascular fitness; and gait analysis.
Biomechanical Exercise (BE): A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
19369|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19443|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
21164|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
19444|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19370|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19371|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19372|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19373|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19374|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19375|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19376|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19377|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19378|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19379|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19380|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19381|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19382|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19383|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19384|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19385|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19386|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19387|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19388|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19389|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19390|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19391|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19392|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19393|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19394|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19395|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
20316|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
19396|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19397|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19398|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19399|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19400|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19401|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19402|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19403|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19404|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19405|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19406|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19407|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19408|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19409|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19410|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19411|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19412|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19413|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19414|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19415|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19416|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19417|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19418|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19419|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19420|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19421|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19422|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19423|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19424|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19425|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19426|NCT02370667|E3|Reported Event|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19427|NCT02370667|E2|Reported Event|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19428|NCT02370667|E1|Reported Event|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
19429|NCT02370615|B3|Baseline|Total|Total of all reporting groups
19430|NCT02370615|B2|Baseline|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once on Day 3 to 8.
19431|NCT02370615|B1|Baseline|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19432|NCT02370615|P2|Participant Flow|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19433|NCT02370615|P1|Participant Flow|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19434|NCT02370615|O1|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19435|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19436|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19437|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19438|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19439|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19440|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19441|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19442|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19447|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19448|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
19449|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19450|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
19451|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19452|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
19453|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19454|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
19455|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19456|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
19457|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19458|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
19459|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19460|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
19461|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19462|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
19463|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19464|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
19465|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19466|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
19467|NCT02370615|E2|Reported Event|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
19468|NCT02370615|E1|Reported Event|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
19469|NCT02370602|B7|Baseline|Total|Total of all reporting groups
19470|NCT02370602|B6|Baseline|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19471|NCT02370602|B5|Baseline|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19472|NCT02370602|B4|Baseline|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19473|NCT02370602|B3|Baseline|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19474|NCT02370602|B2|Baseline|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19475|NCT02370602|B1|Baseline|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
19476|NCT02370602|P6|Participant Flow|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19477|NCT02370602|P5|Participant Flow|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19478|NCT02370602|P4|Participant Flow|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
20317|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
19479|NCT02370602|P3|Participant Flow|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19480|NCT02370602|P2|Participant Flow|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19482|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19483|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19484|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19485|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19486|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19487|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19488|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19489|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19490|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19491|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19492|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19493|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19494|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19495|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19496|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19497|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19498|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19499|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19500|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19501|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19525|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
20318|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
19502|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19741|NCT02369510|P3|Participant Flow|No Epinephrine|"0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
19503|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19504|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19505|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19506|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19507|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19508|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19509|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19510|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19511|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19512|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19513|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19514|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19515|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19516|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19517|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19518|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19519|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19520|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19521|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19522|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19523|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19524|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
21165|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
19526|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19742|NCT02369510|P2|Participant Flow|High-dose Epinephrine|"200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
19527|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19528|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19529|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19530|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19531|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19532|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19533|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19534|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19535|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19536|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19537|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19538|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19539|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19540|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19541|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19542|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19543|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19544|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19545|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
19546|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19547|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19548|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19739|NCT02369510|B2|Baseline|High-dose Epinephrine|"200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
19549|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19550|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19551|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
19552|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19553|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19554|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19555|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19556|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19557|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
19558|NCT02370602|O2|Outcome|TAK-063|TAK-063 3 to 1000 mg, tablets, orally, once, on Day 1.
19559|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
19560|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19561|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19562|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19563|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19564|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
19565|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19566|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
19567|NCT02370602|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19568|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
19569|NCT02370602|E2|Reported Event|TAK-063|TAK-063 3 to 1000 mg, tablets, orally, once, on Day 1.
19570|NCT02370602|E1|Reported Event|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
19571|NCT02370537|B4|Baseline|Total|Total of all reporting groups
19572|NCT02370537|B3|Baseline|Normal FEC (EPANOVA® and OMACOR®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
19573|NCT02370537|B2|Baseline|Intermediate FEC (EPANOVA® and OMACOR®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
19574|NCT02370537|B1|Baseline|Low FEC (EPANOVA® and OMACOR®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
19575|NCT02370537|P3|Participant Flow|Normal FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
20319|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
19740|NCT02369510|B1|Baseline|Low-dose Epinephrine|"100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
19576|NCT02370537|P2|Participant Flow|Intermediate FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to <200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19577|NCT02370537|P1|Participant Flow|Low FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially triglycerides (TGs) and faecal elastase-1 concentration (FEC) as a measure of pancreatic exocrine function in the study population. Patients in the Low FEC group were determined to have FEC levels <100 microgram per gram (mcg/g). No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19578|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19579|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19580|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19581|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19582|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19583|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19584|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19585|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19586|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19587|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19588|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19589|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19590|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19626|NCT02370407|P2|Participant Flow|Mimic da Vinci Robotic Simulator|"20 study participants will be randomized to perform peg board 1 exercise 10 times on a Mimic da Vinci robotic simulator (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA).
Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator."
19591|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19592|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19593|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19594|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19595|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19596|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19597|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19598|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19599|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19600|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19601|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19602|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19603|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19604|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19605|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19606|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19661|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19607|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19608|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19609|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19610|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19611|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19612|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19613|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
19614|NCT02370537|O3|Outcome|Normal FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
19615|NCT02370537|O2|Outcome|Intermediate FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to <200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
19616|NCT02370537|O1|Outcome|Low FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels <100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
19617|NCT02370537|E6|Reported Event|Normal FEC (OMACOR®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
19618|NCT02370537|E5|Reported Event|Normal FEC (EPANOVA®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
19619|NCT02370537|E4|Reported Event|Intermediate FEC (OMACOR®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
19620|NCT02370537|E3|Reported Event|Intermediate FEC (EPANOVA®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
19621|NCT02370537|E2|Reported Event|Low FEC (OMACOR®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
19622|NCT02370537|E1|Reported Event|Low FEC (EPANOVA®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
19623|NCT02370407|B3|Baseline|Total|Total of all reporting groups
19624|NCT02370407|B2|Baseline|Mimic da Vinci Robotic Simulator|"20 study participants will be randomized to perform peg board 1 exercise 10 times on a Mimic da Vinci robotic simulator (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA).
Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator."
19625|NCT02370407|B1|Baseline|Laparoscopic Simulator|"20 study participants will be randomized to perform peg transfer task on a laparoscopic simulator 10 times (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA).
a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator."
19627|NCT02370407|P1|Participant Flow|Laparoscopic Simulator|"20 study participants will be randomized to perform peg transfer task on a laparoscopic simulator 10 times (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA).
a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator."
19628|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
19629|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
19630|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
19631|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
19632|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
19633|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
19634|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
19635|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
19636|NCT02370407|O2|Outcome|Robotic Task|10 repetitions on the robotic task
19637|NCT02370407|O1|Outcome|Laparoscopic|10 repetitions on the laparoscopic task
19638|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
19639|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
19640|NCT02370407|O2|Outcome|Robotic|10 repetitions on robotic task
19641|NCT02370407|O1|Outcome|Laparoscopic|10 repetitions on laparoscopic task
19642|NCT02370407|O2|Outcome|Robotic|10 repetitions on robotic task
19643|NCT02370407|O1|Outcome|Laparoscopic|10 repetitions on laparoscopic task
19644|NCT02370407|O2|Outcome|Robotic Group|Training on robotic platform resulted in improved performance on laparoscopic and robotic task
19645|NCT02370407|O1|Outcome|Laparoscopic Group|Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
19646|NCT02370407|E2|Reported Event|Mimic da Vinci Robotic Simulator|"20 study participants will be randomized to perform peg board 1 exercise 10 times on a Mimic da Vinci robotic simulator (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA).
Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator."
19647|NCT02370407|E1|Reported Event|Laparoscopic Simulator|"20 study participants will be randomized to perform peg transfer task on a laparoscopic simulator 10 times (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA).
Laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator."
19648|NCT02370121|B3|Baseline|Total|Total of all reporting groups
19649|NCT02370121|B2|Baseline|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19650|NCT02370121|B1|Baseline|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19651|NCT02370121|P2|Participant Flow|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19652|NCT02370121|P1|Participant Flow|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19653|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19654|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19655|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19656|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19657|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19658|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19659|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19660|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19662|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19663|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19664|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19665|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19666|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19667|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19668|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19669|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19670|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19671|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19672|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19673|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19674|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19675|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19676|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19677|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19678|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19679|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19680|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19681|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19682|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19683|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19684|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19685|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19686|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19687|NCT02370121|E2|Reported Event|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19688|NCT02370121|E1|Reported Event|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
19689|NCT02369796|B6|Baseline|Total|Total of all reporting groups
19690|NCT02369796|B5|Baseline|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19691|NCT02369796|B4|Baseline|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19692|NCT02369796|B3|Baseline|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19693|NCT02369796|B2|Baseline|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19694|NCT02369796|B1|Baseline|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19695|NCT02369796|P5|Participant Flow|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19696|NCT02369796|P4|Participant Flow|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19697|NCT02369796|P3|Participant Flow|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19698|NCT02369796|P2|Participant Flow|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19699|NCT02369796|P1|Participant Flow|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19700|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19701|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19702|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19703|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19704|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19705|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19706|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19707|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19708|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19709|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19710|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19711|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19712|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19713|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19714|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19715|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19716|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19717|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19718|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19719|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19720|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19721|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19722|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19723|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19724|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19725|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19726|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19727|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19728|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
19729|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
19730|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
21166|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
19743|NCT02369510|P1|Participant Flow|Low-dose Epinephrine|"100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
19744|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
19745|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
19746|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
19747|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
19748|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
19749|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
19750|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
19751|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
19752|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
19753|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
19754|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
19755|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
19756|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
19757|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
19758|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
19759|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
19760|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
19761|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
19762|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
19763|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
19764|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
19765|NCT02369510|O3|Outcome|No Epinephrine|"0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
19766|NCT02369510|O2|Outcome|High-dose Epinephrine|"200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
19767|NCT02369510|O1|Outcome|Low-dose Epinephrine|"100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
19768|NCT02369510|E3|Reported Event|No Epinephrine|"0.2ml saline
No epinephrine: 0.2ml of preservative-free saline will be added to the standard spinal medications"
19769|NCT02369510|E2|Reported Event|High-dose Epinephrine|"200micrograms of epinephrine group
High-dose epinephrine: 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications"
19770|NCT02369510|E1|Reported Event|Low-dose Epinephrine|"100micrograms of epinephrine group
Low-dose epinephrine: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications"
19771|NCT02369341|B3|Baseline|Total|Total of all reporting groups
19772|NCT02369341|B2|Baseline|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19773|NCT02369341|B1|Baseline|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19774|NCT02369341|P2|Participant Flow|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
20320|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
19775|NCT02369341|P1|Participant Flow|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19776|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
20330|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
19777|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19778|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19779|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19780|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19781|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19782|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19783|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19784|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19785|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19786|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19787|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19788|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19789|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19790|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
19791|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
19792|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
19793|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
19794|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
19795|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
19796|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
19797|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
19798|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
19799|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
21167|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
19800|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
20331|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
41454|NCT02151994|E8|Reported Event|800 mg (SAD)|SAD period
19801|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
19802|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
19803|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
19804|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
19805|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
19806|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
19807|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
19808|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
19809|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
19810|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
19811|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
19812|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
19813|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
19814|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19815|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19816|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19817|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19818|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19819|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19820|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19821|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19822|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19823|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
20321|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
19824|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19825|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19826|NCT02369341|E2|Reported Event|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged ˃60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19827|NCT02369341|E1|Reported Event|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
19828|NCT02368457|B3|Baseline|Total|Total of all reporting groups
19829|NCT02368457|B2|Baseline|Control Group|No drug treatment
19830|NCT02368457|B1|Baseline|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.
Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
19831|NCT02368457|P2|Participant Flow|Control Group|No drug treatment
19832|NCT02368457|P1|Participant Flow|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.
Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
19833|NCT02368457|O2|Outcome|CONTROL|No drug treatment
19834|NCT02368457|O1|Outcome|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.
Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
19835|NCT02368457|O2|Outcome|Control Group|Standard treatment
19836|NCT02368457|O1|Outcome|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.
Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
19837|NCT02368457|E2|Reported Event|Control Group|Standard treatment
19838|NCT02368457|E1|Reported Event|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.
Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
19839|NCT02368314|B3|Baseline|Total|Total of all reporting groups
19840|NCT02368314|B2|Baseline|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
19841|NCT02368314|B1|Baseline|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
19842|NCT02368314|P2|Participant Flow|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
19843|NCT02368314|P1|Participant Flow|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
19844|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
19845|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
19846|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
19847|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
19848|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
19849|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
20608|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
19880|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19850|NCT02368314|E2|Reported Event|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
19851|NCT02368314|E1|Reported Event|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
19852|NCT02368093|B3|Baseline|Total|Total of all reporting groups
19853|NCT02368093|B2|Baseline|Placebo|Placebo pills with the same appearance as Detosiv tablets once daily for 6 months.
19854|NCT02368093|B1|Baseline|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast for 6 months
19855|NCT02368093|P2|Participant Flow|Placebo|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.
Placebo pills with the same appearance as Dextromethorphan hydrobromide tablets once daily were given for 6 months."
19856|NCT02368093|P1|Participant Flow|Dextromethorphan|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.
Dextromethorphan hydrobromide 120mg once daily were given for 6 months."
19857|NCT02368093|O2|Outcome|Placebo|placebo pills with the same appearance as Detosiv tablets.
19858|NCT02368093|O1|Outcome|Dextromethorphan Hydrobromide|"Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast]
Dextromethorphan hydrobromide: 120mg per day with once daily dose taken after breakfast for 6 months"
19859|NCT02368093|E2|Reported Event|Placebo|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.
Placebo pills with the same appearance as Dextromethorphan hydrobromide tablets once daily were given for 6 months."
19860|NCT02368093|E1|Reported Event|Dextromethorphan|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.
Dextromethorphan hydrobromide 120mg once daily were given for 6 months."
19861|NCT02367885|B4|Baseline|Total|Total of all reporting groups
19862|NCT02367885|B3|Baseline|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19863|NCT02367885|B2|Baseline|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19864|NCT02367885|B1|Baseline|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19865|NCT02367885|P3|Participant Flow|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19866|NCT02367885|P2|Participant Flow|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19867|NCT02367885|P1|Participant Flow|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19868|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19869|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19870|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19871|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19872|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19873|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19874|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19875|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19876|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19877|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19878|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19879|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19881|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19882|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19883|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19884|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19885|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19886|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19887|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19888|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19889|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19890|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19891|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19892|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19893|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19894|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19895|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19896|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19897|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19898|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19899|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19900|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19901|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19902|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19903|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19904|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19905|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19906|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19907|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19908|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
20322|NCT02365298|E2|Reported Event|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
19909|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19910|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19911|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19912|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19913|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19914|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19915|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19916|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19917|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19918|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19919|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19920|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19921|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19922|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19923|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19924|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19925|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19926|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19927|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19928|NCT02367885|E3|Reported Event|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
19929|NCT02367885|E2|Reported Event|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19930|NCT02367885|E1|Reported Event|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
19931|NCT02367872|B9|Baseline|Total|Total of all reporting groups
19932|NCT02367872|B8|Baseline|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19933|NCT02367872|B7|Baseline|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19934|NCT02367872|B6|Baseline|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19953|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
21168|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
20327|NCT02364778|P1|Participant Flow|Provisional Stenting Strategy|Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned.
19935|NCT02367872|B5|Baseline|Cohort 5R: End-stage Renal Failure (Hemodialysis)|Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (dialysis on Day 1 after dosing). After Part 1 follow-up period, then the same participants received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-dialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day of follow up in Part 1.
19936|NCT02367872|B4|Baseline|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19937|NCT02367872|B3|Baseline|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19938|NCT02367872|B2|Baseline|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19939|NCT02367872|B1|Baseline|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19940|NCT02367872|P8|Participant Flow|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19941|NCT02367872|P7|Participant Flow|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time [PT] or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19942|NCT02367872|P6|Participant Flow|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19943|NCT02367872|P5|Participant Flow|Cohort 5R: End-stage Renal Failure (Hemodialysis)|Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (dialysis on Day 1 after dosing). After Part 1 follow-up period, then the same participants received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-dialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day of follow up in Part 1.
19944|NCT02367872|P4|Participant Flow|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19945|NCT02367872|P3|Participant Flow|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19946|NCT02367872|P2|Participant Flow|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60, less than [<] 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19947|NCT02367872|P1|Participant Flow|Cohort 1R: Normal Renal Function|Participants with normal renal function (estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 90 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2]) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19948|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19949|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19950|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19951|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
19952|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20323|NCT02365298|E1|Reported Event|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
19954|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19955|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19956|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19957|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19958|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19959|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19960|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
19961|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
19962|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19963|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19964|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19965|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19966|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19967|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19968|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19969|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
19970|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
19971|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19972|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19973|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19974|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19975|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19976|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19977|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19978|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
19979|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
19980|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19981|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19982|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19983|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19984|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19985|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19986|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19987|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
19988|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
19989|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19990|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19991|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19992|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19993|NCT02367872|O1|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20013|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20324|NCT02364778|B3|Baseline|Total|Total of all reporting groups
20325|NCT02364778|B2|Baseline|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
19994|NCT02367872|O8|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19995|NCT02367872|O7|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
19996|NCT02367872|O6|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19997|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
19998|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
19999|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20000|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20001|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20002|NCT02367872|O7|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20003|NCT02367872|O6|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20004|NCT02367872|O5|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20005|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20006|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20007|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20008|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20009|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20010|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20011|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20012|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
20035|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20014|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20015|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20016|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20017|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20018|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20019|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20020|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20021|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
20022|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20023|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20024|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20025|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20026|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20027|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20028|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20029|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20030|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
20031|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20032|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20033|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20034|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20036|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20037|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20038|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20039|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
20040|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20041|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20042|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20043|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20044|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20045|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20046|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20047|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20048|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
20049|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20050|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20051|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20052|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20053|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20054|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20178|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20179|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20180|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20181|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20055|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20056|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20057|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
20058|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20059|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20060|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20061|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20062|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20063|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20064|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20065|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20066|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
20067|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20068|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20069|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20070|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20071|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20072|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20073|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20074|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20075|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
20076|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20077|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20078|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20079|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20080|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20081|NCT02367872|O9|Outcome|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20082|NCT02367872|O8|Outcome|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20083|NCT02367872|O7|Outcome|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20084|NCT02367872|O6|Outcome|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
20085|NCT02367872|O5|Outcome|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20086|NCT02367872|O4|Outcome|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20087|NCT02367872|O3|Outcome|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20088|NCT02367872|O2|Outcome|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20089|NCT02367872|O1|Outcome|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20090|NCT02367872|E9|Reported Event|Cohort 3H: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20091|NCT02367872|E8|Reported Event|Cohort 2H: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.
20092|NCT02367872|E7|Reported Event|Cohort 1H: Normal Hepatic Function|Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20093|NCT02367872|E6|Reported Event|Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)|Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1.
20094|NCT02367872|E5|Reported Event|Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)|Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing).
20095|NCT02367872|E4|Reported Event|Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)|Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20096|NCT02367872|E3|Reported Event|Cohort 3R: Moderate Renal Impairment|Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20097|NCT02367872|E2|Reported Event|Cohort 2R: Mild Renal Impairment|Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20098|NCT02367872|E1|Reported Event|Cohort 1R: Normal Renal Function|Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period.
20099|NCT02367391|B3|Baseline|Total|Total of all reporting groups
20100|NCT02367391|B2|Baseline|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
20101|NCT02367391|B1|Baseline|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
20102|NCT02367391|P2|Participant Flow|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
20103|NCT02367391|P1|Participant Flow|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
20104|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
20105|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
20106|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
20107|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
20108|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
20109|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
20110|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
20111|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
20112|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
20113|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
20114|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
20115|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
20116|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
20117|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
20118|NCT02367391|E2|Reported Event|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
20119|NCT02367391|E1|Reported Event|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
20120|NCT02367170|B3|Baseline|Total|Total of all reporting groups
20121|NCT02367170|B2|Baseline|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
20122|NCT02367170|B1|Baseline|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
20123|NCT02367170|P2|Participant Flow|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
20124|NCT02367170|P1|Participant Flow|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
20125|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
20182|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20183|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20184|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20126|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
20127|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
20128|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
20129|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
20130|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
20131|NCT02367170|E2|Reported Event|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
20132|NCT02367170|E1|Reported Event|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
20133|NCT02367066|B3|Baseline|Total|Total of all reporting groups
20134|NCT02367066|B2|Baseline|Placebo-AZD1981|Sequence Placebo-AZD1981
20135|NCT02367066|B1|Baseline|AZD1981-Placebo|Sequence AZD1981-Placebo
20136|NCT02367066|P2|Participant Flow|Placebo-AZD1981|Sequence Placebo-AZD1981
20137|NCT02367066|P1|Participant Flow|AZD1981-Placebo|Sequence AZD1981-Placebo
20138|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
20139|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
20140|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
20141|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
20142|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
20143|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
20144|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
20145|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
20146|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20147|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20148|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20149|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20150|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20151|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20152|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20153|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20154|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20155|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20156|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
20157|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
20158|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
20159|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
20160|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
20161|NCT02367066|O1|Outcome|MMTT|Mixed Meal Tolerance Test (MMTT)
20162|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
20163|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
20164|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 infusion)
20165|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
20166|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded glucose and GLP1 infusion)
20167|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
20168|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20169|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20170|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20171|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20172|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20173|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20174|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20175|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20176|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
20177|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
20194|NCT02366936|B1|Baseline|Use of Tortle Midliner|"This study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner.
Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g."
20195|NCT02366936|P1|Participant Flow|Use of Tortle Midliner|"This study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner.
Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g."
20196|NCT02366936|O1|Outcome|Use of Tortle Midliner|Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
20197|NCT02366936|O1|Outcome|Use of Tortle Midliner|Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
20198|NCT02366936|E1|Reported Event|Use of Tortle Midliner|Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
20199|NCT02366923|B1|Baseline|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.
stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table
delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
20200|NCT02366923|P1|Participant Flow|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.
stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table
delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
20201|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20202|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20203|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20204|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20205|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20206|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20207|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20208|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20209|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20210|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20211|NCT02366923|E1|Reported Event|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.
stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table
delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
20326|NCT02364778|B1|Baseline|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
20212|NCT02366910|B1|Baseline|Overall Participants|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20213|NCT02366910|P1|Participant Flow|Overall Participants|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20214|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20215|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20216|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20217|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20218|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20219|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20220|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20221|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20222|NCT02366910|E2|Reported Event|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20223|NCT02366910|E1|Reported Event|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
20224|NCT02366767|B3|Baseline|Total|Total of all reporting groups
20225|NCT02366767|B2|Baseline|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.
Control: Threshold suspend"
20226|NCT02366767|B1|Baseline|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes
Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
20227|NCT02366767|P2|Participant Flow|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.
Control: Threshold suspend"
20228|NCT02366767|P1|Participant Flow|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes
Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
20229|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.
Control: Threshold suspend"
20230|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes
Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
20231|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.
Control: Threshold suspend"
20232|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes
Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
20233|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.
Control: Threshold suspend"
20234|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes
Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
20235|NCT02366767|E2|Reported Event|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.
Control: Threshold suspend"
20273|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20236|NCT02366767|E1|Reported Event|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes
Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
20237|NCT02366689|B4|Baseline|Total|Total of all reporting groups
20238|NCT02366689|B3|Baseline|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash
fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
20239|NCT02366689|B2|Baseline|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
20240|NCT02366689|B1|Baseline|Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
20241|NCT02366689|P3|Participant Flow|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash
fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
20242|NCT02366689|P2|Participant Flow|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
20243|NCT02366689|P1|Participant Flow|Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
20244|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash
fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
20245|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
20246|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
20247|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash
fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
20248|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
20249|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
20250|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash
fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
20251|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
20252|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
20274|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20367|NCT02362412|O2|Outcome|Treatment Period II FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period II (8 weeks).
20253|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash
fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
20254|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
20255|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
20256|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash
fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
20257|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
20258|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
20259|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash
fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
20260|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
20261|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
20262|NCT02366689|E3|Reported Event|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash
fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
20263|NCT02366689|E2|Reported Event|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
20264|NCT02366689|E1|Reported Event|Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
20265|NCT02366637|B1|Baseline|All Participants|All participants who received at least 1 dose of study drug (PF-03715455 or placebo).
20266|NCT02366637|P2|Participant Flow|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20267|NCT02366637|P1|Participant Flow|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20268|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20269|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20270|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20271|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20272|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
21169|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
20275|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20276|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20277|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20278|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20279|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20280|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20281|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20282|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20283|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20284|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20285|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20286|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20287|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20288|NCT02366637|E2|Reported Event|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20289|NCT02366637|E1|Reported Event|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
20290|NCT02366338|B4|Baseline|Total|Total of all reporting groups
20291|NCT02366338|B3|Baseline|Group 3|Patients on dabigatran therapy
20292|NCT02366338|B2|Baseline|Group 2|patients on rivaroxaban therapy
20293|NCT02366338|B1|Baseline|Group 1|patients on warfarin therapy
20294|NCT02366338|P3|Participant Flow|Group 3|Patients on dabigatran therapy
20295|NCT02366338|P2|Participant Flow|Group 2|patients on rivaroxaban therapy
20296|NCT02366338|P1|Participant Flow|Group 1|patients on warfarin therapy
20297|NCT02366338|O3|Outcome|Group 3|Patients on dabigatran therapy
20298|NCT02366338|O2|Outcome|Group 2|patients on rivaroxaban therapy
20299|NCT02366338|O1|Outcome|Group 1|patients on warfarin therapy
20300|NCT02366338|E3|Reported Event|Group 3|Patients on dabigatran therapy
20301|NCT02366338|E2|Reported Event|Group 2|patients on rivaroxaban therapy
20302|NCT02366338|E1|Reported Event|Group 1|patients on warfarin therapy
20303|NCT02365688|B1|Baseline|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded
Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
20304|NCT02365688|P1|Participant Flow|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded
Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
20305|NCT02365688|O1|Outcome|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded
Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
20306|NCT02365688|E1|Reported Event|Pre-surgical Bolus|Pre-surgical bolus of 500 cc before incision rather than during incision for baseline hemodynamic data
20307|NCT02365298|B1|Baseline|All Dispensed Subjects|All subjects that were dispensed a study lens.
20308|NCT02365298|P2|Participant Flow|Nelfilcon A / Etafilcon A|Subjects that were randomized to receive the nelfilcon A lens first, and then to receive the etafilcon A lens second.
20309|NCT02365298|P1|Participant Flow|Etafilcon a /Nelfilcon A|Subjects that were randomized to receive the etafilcon A lens first, and then to receive the nelfilcon A lens second.
20310|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
20311|NCT02365298|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens in either the first or second period of the study.
20312|NCT02365298|O2|Outcome|Nelfilcon A|Subjects that wore the nelfilcon A lens in either the first or second period of the study.
20332|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
20333|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
20334|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
20335|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
20336|NCT02364778|E2|Reported Event|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
20337|NCT02364778|E1|Reported Event|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
20338|NCT02364700|B1|Baseline|Interventional Group|This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks.
20339|NCT02364700|P1|Participant Flow|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks"
20340|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks"
20341|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks"
20342|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks"
20343|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks"
20344|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks"
20345|NCT02364700|O1|Outcome|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks"
20346|NCT02364700|E1|Reported Event|Interventional Group|"This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks"
20347|NCT02364180|B1|Baseline|Pyridostigmine Bromide Treatment Group|All subjects investigated were taking pyridostigmine.
20348|NCT02364180|P1|Participant Flow|Pyridostigmine Bromide Treatment Group|pyridostigmine bromide treatment is a single arm. Subjects must be treated with pyridostigmine for at least 6months and must not be treated for myasthenia gravis.
20349|NCT02364180|O1|Outcome|Pyridostigmine Bromide Treatment Group|Subjects taking pyridostigmine bromide for more than 6 months for a condition other than myasthenia gravis
20350|NCT02364180|E1|Reported Event|Pyridostigmine Bromide Treatment Group|In all enrolled subjects (10), who were known pyridostigmine bromide pts that were observed with Electromyography (EMG), there were no adverse events anticipated.
20351|NCT02363907|B1|Baseline|Single Arm|Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
20352|NCT02363907|P1|Participant Flow|Single Arm- Performance, Using Blood Glucose Meter Reference|Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
20353|NCT02363907|O1|Outcome|Single Arm|Subjects as their own control, comparing ISF glucose readings to capillary blood glucose readings, measured by blood glucose meters
20354|NCT02363907|E1|Reported Event|Single Arm,Performance, Using Blood Glucose Meter Reference|Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
20355|NCT02363478|B1|Baseline|Buspirone|22 out of 30 participants (19 female) completed the study.
20356|NCT02363478|P1|Participant Flow|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
20357|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
20358|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
20359|NCT02363478|O1|Outcome|Buspirone|"4-weeks buspirone administration (20mg) in patients with SSc and esophageal involvement
buspirone: buspirone 10 mg X2 for 4 weeks"
20360|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
20361|NCT02363478|E1|Reported Event|Buspirone|Participants received bouspirone 20 mg/day for 4 weeks
20362|NCT02362412|B1|Baseline|All Study Participants|Participants who received either FK949E 50 mg tablets or FK949E 150 mg tablets once daily. The analysis population was the Full Analysis Set (FAS), which consisted of all participants who received at least one dose of the study drug and who had at least one efficacy measurement after the start of treatment with the study drug.
20363|NCT02362412|P2|Participant Flow|FK949E 150 mg / FK949E 50 mg|Participants who received the 150 mg tablet once daily during Treatment Period II (8 weeks) and 50 mg tablet once daily during Treatment Period III (8 weeks).
20364|NCT02362412|P1|Participant Flow|FK949E 50 mg / FK949E 150 mg|Participants who received the 50 mg tablet once daily during Treatment Period II (8 weeks) and 150 mg tablet once daily during Treatment Period III (8 weeks).
20365|NCT02362412|O4|Outcome|Treatment Period III FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period III (8 weeks).
20366|NCT02362412|O3|Outcome|Treatment Period III FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period III (8 weeks).
21170|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
20368|NCT02362412|O1|Outcome|Treatment Period II FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period II (8 weeks).
20369|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20370|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20407|NCT02362321|P2|Participant Flow|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
20371|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20372|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20373|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20374|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20375|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20376|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20377|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20378|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20379|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20380|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20381|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20382|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20383|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20384|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
20385|NCT02362412|E4|Reported Event|Treatment Period III FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period III (8 weeks).
20386|NCT02362412|E3|Reported Event|Treatment Period III FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period III (8 weeks).
20387|NCT02362412|E2|Reported Event|Treatment Period II FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily duringr Treatment Period II (8 weeks).
20388|NCT02362412|E1|Reported Event|Treatment Period II FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period II (8 weeks).
20389|NCT02362373|B1|Baseline|Levonorgestrel IUS|"all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement.
levonorgestrel IUS: placement of levonorgestrel intrauterine system"
20390|NCT02362373|P1|Participant Flow|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
20391|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
20392|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
20393|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
20394|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
20395|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
20396|NCT02362373|E1|Reported Event|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
20397|NCT02362360|B1|Baseline|Overall Study Population|All subjects included in the investigation
20398|NCT02362360|P2|Participant Flow|Comparator Then Coloplast Test Product|"The subject first tests the Comparator and then tests the Coloplast Test Product.
Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S
Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag."
20399|NCT02362360|P1|Participant Flow|Coloplast Test Product Then Comparator|"The subject first tests the Coloplast Test Product and then tests the Comparator
Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S
Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag."
20400|NCT02362360|O2|Outcome|Comparator|Answers from subjects testing Comparator
20401|NCT02362360|O1|Outcome|Coloplast Test Product|Answers from subjects testing Coloplast test product
20402|NCT02362360|E2|Reported Event|Comparator|Answers from subjects testing Comparator
20403|NCT02362360|E1|Reported Event|Coloplast Test Product|Answers from subjects testing Coloplast test product
20404|NCT02362321|B3|Baseline|Total|Total of all reporting groups
20405|NCT02362321|B2|Baseline|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
20429|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
20609|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
20406|NCT02362321|B1|Baseline|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).
Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
20408|NCT02362321|P1|Participant Flow|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).
Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
20409|NCT02362321|O2|Outcome|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
20410|NCT02362321|O1|Outcome|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).
Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
20411|NCT02362321|E2|Reported Event|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
20412|NCT02362321|E1|Reported Event|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).
Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
20413|NCT02361736|B3|Baseline|Total|Total of all reporting groups
20414|NCT02361736|B2|Baseline|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery
Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
20415|NCT02361736|B1|Baseline|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
20416|NCT02361736|P2|Participant Flow|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery
Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
20417|NCT02361736|P1|Participant Flow|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
20418|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery
Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
20419|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
20420|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery
Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
20421|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
20422|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery
Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
20423|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
20424|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery
Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
20425|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
20426|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery
Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
20427|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
20428|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery
Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
20430|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery
Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
20431|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
20610|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
20432|NCT02361736|E2|Reported Event|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery
Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
20433|NCT02361736|E1|Reported Event|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
20434|NCT02361580|B3|Baseline|Total|Total of all reporting groups
20435|NCT02361580|B2|Baseline|No Diary|Control Group
20436|NCT02361580|B1|Baseline|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.
Diary: Subject keeps diary of recovery"
20437|NCT02361580|P2|Participant Flow|No Diary|Control Group
20438|NCT02361580|P1|Participant Flow|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.
Diary: Subject keeps diary of recovery"
20439|NCT02361580|O2|Outcome|No Diary|Control Group
20440|NCT02361580|O1|Outcome|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.
Diary: Subject keeps diary of recovery"
20441|NCT02361580|O2|Outcome|No Diary|Control Group
20442|NCT02361580|O1|Outcome|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.
Diary: Subject keeps diary of recovery"
20443|NCT02361580|O2|Outcome|No Diary|Control Group
20444|NCT02361580|O1|Outcome|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.
Diary: Subject keeps diary of recovery"
20445|NCT02361580|E2|Reported Event|No Diary|Control Group
20446|NCT02361580|E1|Reported Event|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.
Diary: Subject keeps diary of recovery"
20447|NCT02360995|B4|Baseline|Total|Total of all reporting groups
20448|NCT02360995|B3|Baseline|Control Group|"fluoride toothpaste +fluoride mouthwash
fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
20449|NCT02360995|B2|Baseline|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
20450|NCT02360995|B1|Baseline|Total Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
20451|NCT02360995|P3|Participant Flow|Control Group|"fluoride toothpaste +fluoride mouthwash
fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
20452|NCT02360995|P2|Participant Flow|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
20453|NCT02360995|P1|Participant Flow|Total Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
20454|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash
fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
20455|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
20456|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
20457|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash
fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
20565|NCT02359955|B3|Baseline|Total|Total of all reporting groups
20458|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
20611|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
41455|NCT02151994|E7|Reported Event|400 mg (SAD)|SAD period
20459|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
20460|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash
fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
20461|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
20462|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
20463|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash
fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
20464|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
20465|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
20466|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash
fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
20467|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
20468|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
20469|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash
fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
20470|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
20471|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
20472|NCT02360995|E3|Reported Event|Control Group|"fluoride toothpaste +fluoride mouthwash
fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
20473|NCT02360995|E2|Reported Event|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
20474|NCT02360995|E1|Reported Event|Total Toothpaste|"Triclosan/fluoride toothpaste
Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
20475|NCT02360475|B5|Baseline|Total|Total of all reporting groups
20476|NCT02360475|B4|Baseline|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20477|NCT02360475|B3|Baseline|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20478|NCT02360475|B2|Baseline|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20604|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, intramuscular injection
20605|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, subcutaneously
20479|NCT02360475|B1|Baseline|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
41456|NCT02151994|E6|Reported Event|200 mg (SAD)|SAD period
20480|NCT02360475|P4|Participant Flow|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20481|NCT02360475|P3|Participant Flow|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20482|NCT02360475|P2|Participant Flow|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20483|NCT02360475|P1|Participant Flow|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20484|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20485|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20486|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20487|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20488|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20489|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20490|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20491|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20492|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20493|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20494|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20495|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20496|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20497|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20498|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20499|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20500|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20501|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20502|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20503|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20504|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20505|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20506|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20507|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20508|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20509|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20510|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20511|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20512|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20513|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20514|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20515|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20516|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20517|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20518|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20519|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20520|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20521|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20522|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20523|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20524|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20525|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20526|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20527|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20528|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20529|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20530|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20531|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20532|NCT02360475|O4|Outcome|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20533|NCT02360475|O3|Outcome|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20534|NCT02360475|O2|Outcome|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20535|NCT02360475|O1|Outcome|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20536|NCT02360475|E4|Reported Event|Boostrix Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20537|NCT02360475|E3|Reported Event|GSK3003891A 60 Adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20538|NCT02360475|E2|Reported Event|GSK3003891A 60 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20539|NCT02360475|E1|Reported Event|GSK3003891A 30 Non-adjuvanted Group|Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
20540|NCT02360124|B4|Baseline|Total|Total of all reporting groups
20541|NCT02360124|B3|Baseline|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
20542|NCT02360124|B2|Baseline|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
20543|NCT02360124|B1|Baseline|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.
Water as placebo: topical application of water as a placebo in the control arm"
20544|NCT02360124|P3|Participant Flow|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
20606|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
20607|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
21171|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
20612|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
20613|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
41457|NCT02151994|E5|Reported Event|100 mg (SAD)|SAD period
20545|NCT02360124|P2|Participant Flow|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
20546|NCT02360124|P1|Participant Flow|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.
Water as placebo: topical application of water as a placebo in the control arm"
20547|NCT02360124|O3|Outcome|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces
saturated potassium iodide solution: topical application of SDF solution followed by KI solution onto tooth root surfaces"
20548|NCT02360124|O2|Outcome|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
20549|NCT02360124|O1|Outcome|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water as placebo with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.
Water as placebo: topical application of water as a placebo in the control arm"
20550|NCT02360124|O3|Outcome|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
20551|NCT02360124|O2|Outcome|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
20552|NCT02360124|O1|Outcome|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.
Water as placebo: topical application of water as a placebo in the control arm"
20553|NCT02360124|E3|Reported Event|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
20554|NCT02360124|E2|Reported Event|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
20555|NCT02360124|E1|Reported Event|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.
Water as placebo: topical application of water as a placebo in the control arm"
20556|NCT02360059|B3|Baseline|Total|Total of all reporting groups
20557|NCT02360059|B2|Baseline|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
20558|NCT02360059|B1|Baseline|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
20559|NCT02360059|P2|Participant Flow|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
20560|NCT02360059|P1|Participant Flow|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
20561|NCT02360059|O2|Outcome|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
20562|NCT02360059|O1|Outcome|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
20563|NCT02360059|E2|Reported Event|Placebo Group|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
20564|NCT02360059|E1|Reported Event|Metformin Group|Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
20566|NCT02359955|B2|Baseline|Group 2|"edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture
anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture"
20567|NCT02359955|B1|Baseline|Group 1|"edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture
anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture"
20568|NCT02359955|P2|Participant Flow|Anatomic Teeth, Then Zero-degree Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
20569|NCT02359955|P1|Participant Flow|Zero-degree Teeth, Then Anatomic Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
20570|NCT02359955|O4|Outcome|Duration of Left Masseter of Anatomic Teeth|
20571|NCT02359955|O3|Outcome|Duration of Right Masster of Anatomic Teeth|emg parameter of patients treated with anatomic teeth complete denture
20572|NCT02359955|O2|Outcome|Duration of Left Masseter of Zero Degree Teeth|
20573|NCT02359955|O1|Outcome|Duration of Right Masseter of Zero Degree Teeth|emg parameter of patients treated with zero degree teeth
20574|NCT02359955|O4|Outcome|Amp Value of Left Masseter of Anatomic Teeth|
20575|NCT02359955|O3|Outcome|Amp Value of Right Master of Anatomic Teeth|emg parameter of patients treated with anatomic teeth complete denture
20576|NCT02359955|O2|Outcome|Amp Value of Left Masseter of Zero Degree Teeth|
20577|NCT02359955|O1|Outcome|Amp Value of Right Masseter of Zero Degree Teeth|emg parameter of edentulous patients treated with zero-degree teeth complete denture
20578|NCT02359955|O4|Outcome|Group 2 Zero Degree Teeth|
20579|NCT02359955|O3|Outcome|Group 1 Anatomic Teeth|
20580|NCT02359955|O2|Outcome|Group 2 Anatomic Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
20581|NCT02359955|O1|Outcome|Group 1 Zero Degree Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
20582|NCT02359955|E2|Reported Event|Anatomic Teeth, Then Zero-degree Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
20583|NCT02359955|E1|Reported Event|Zero Degree Teeth,Then Anatomic Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
20584|NCT02359903|B3|Baseline|Total|Total of all reporting groups
20585|NCT02359903|B2|Baseline|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
Infliximab (Remicade)"
20586|NCT02359903|B1|Baseline|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
20587|NCT02359903|P2|Participant Flow|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
Infliximab (Remicade)"
20588|NCT02359903|P1|Participant Flow|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
20589|NCT02359903|O2|Outcome|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
Infliximab (Remicade)"
20590|NCT02359903|O1|Outcome|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
20591|NCT02359903|O2|Outcome|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
Infliximab (Remicade)"
20592|NCT02359903|O1|Outcome|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
20593|NCT02359903|E2|Reported Event|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
Infliximab (Remicade)"
20594|NCT02359903|E1|Reported Event|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
20595|NCT02359877|B5|Baseline|Total|Total of all reporting groups
20596|NCT02359877|B4|Baseline|BCD-054 (Multiple Doses)|Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
20597|NCT02359877|B3|Baseline|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
20598|NCT02359877|B2|Baseline|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
20599|NCT02359877|B1|Baseline|BCD-054 (Single Doses)|Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; or 120 mcg, IM/SC; or 240 mcg, IM/SC; or 360 mcg, IM/SC
20600|NCT02359877|P4|Participant Flow|BCD-054 (Multiple Dose)|Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
20601|NCT02359877|P3|Participant Flow|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
20602|NCT02359877|P2|Participant Flow|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
20603|NCT02359877|P1|Participant Flow|BCD-054 (Single Doses)|Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; or 120 mcg, IM/SC; or 240 mcg, IM/SC; or 360 mcg, IM/SC
20614|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
20615|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
20616|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054)
20617|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054)
20618|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
20619|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
20620|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
20621|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
20622|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
20623|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
20624|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
20625|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
20626|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
20627|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
20628|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054)
20629|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054)
20630|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
20631|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
20632|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
20633|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
20634|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
20635|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
20636|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
20637|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
20638|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
20639|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
20640|NCT02359877|E12|Reported Event|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, intramuscular injection
20641|NCT02359877|E11|Reported Event|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, subcutaneously
20642|NCT02359877|E10|Reported Event|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
20643|NCT02359877|E9|Reported Event|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
20644|NCT02359877|E8|Reported Event|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
20645|NCT02359877|E7|Reported Event|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
20646|NCT02359877|E6|Reported Event|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
20647|NCT02359877|E5|Reported Event|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
20648|NCT02359877|E4|Reported Event|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
20649|NCT02359877|E3|Reported Event|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
20650|NCT02359877|E2|Reported Event|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
20651|NCT02359877|E1|Reported Event|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
20652|NCT02359435|B3|Baseline|Total|Total of all reporting groups
20653|NCT02359435|B2|Baseline|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily
Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
20654|NCT02359435|B1|Baseline|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily
Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
20655|NCT02359435|P2|Participant Flow|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily
Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
20685|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
21172|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21173|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
20656|NCT02359435|P1|Participant Flow|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily
Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
41458|NCT02151994|E4|Reported Event|50 mg (SAD)|SAD period
20657|NCT02359435|O2|Outcome|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily
Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
20658|NCT02359435|O1|Outcome|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily
Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
20659|NCT02359435|E2|Reported Event|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily
Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
20660|NCT02359435|E1|Reported Event|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily
Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
20661|NCT02359045|B3|Baseline|Total|Total of all reporting groups
20662|NCT02359045|B2|Baseline|Part 2|"Subjects received a single dose of 3 treatments for 3 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the two different prototype capsule formulations (Treatment A, B) in relation to Epanova capsules (Treatment C), under fed conditions.
A-D1400147, B- D14000136 or D14000137 & C- Epanova."
20663|NCT02359045|B1|Baseline|Part 1|"Subjects received a single dose of 4 treatments for 4 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the three different prototype capsule formulations (Treatment A, B, C) in relation to Epanova capsules (Treatment D), under fasted conditions.
A- D1400147, B- D14000136, C- D14000137 & D- Epanova."
20664|NCT02359045|P2|Participant Flow|Part 2|"Subjects received a single dose of 3 treatments for 3 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the two different prototype capsule formulations (Treatment A, B) in relation to Epanova capsules (Treatment C), under fed conditions.
A-D1400147, B- D14000136 or D14000137 & C- Epanova."
20665|NCT02359045|P1|Participant Flow|Part 1|"Subjects received a single dose of 4 treatments for 4 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the three different prototype capsule formulations (Treatment A, B, C) in relation to Epanova capsules (Treatment D), under fasted conditions.
A- D1400147, B- D14000136, C- D14000137 & D- Epanova."
20666|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20667|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20668|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20669|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20670|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20671|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20672|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20673|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20674|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20675|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20676|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20677|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20678|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20679|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20680|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20681|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20682|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20683|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20684|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20686|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20687|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20799|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20688|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20689|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20690|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20691|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20692|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20693|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20694|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20695|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20696|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20697|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20698|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20699|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20700|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20701|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20702|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20703|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20704|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20705|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20706|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20707|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20708|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20709|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20710|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20711|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20712|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20713|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20714|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20715|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20716|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20717|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20718|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20719|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20720|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20721|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20722|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20760|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20723|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
21175|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
20724|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20725|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20726|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20727|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20728|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20729|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20730|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20731|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20732|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20733|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20734|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20735|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20736|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20737|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20738|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20739|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20740|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20741|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20742|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20743|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20744|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20745|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20746|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20747|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20748|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20749|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20750|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20751|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20752|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20753|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20754|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20755|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20756|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20757|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20758|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20759|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20761|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
21176|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
20762|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20763|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20764|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20765|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20766|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20767|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20768|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20769|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20770|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20771|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20772|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20773|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20774|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20775|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20776|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20777|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20778|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20779|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20780|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20781|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20782|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20783|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20784|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20785|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20786|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20787|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20788|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20789|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20790|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20791|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20792|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20793|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20794|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20795|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20796|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20797|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
21174|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
20798|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20800|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20801|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20802|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20803|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20804|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20805|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20806|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20807|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20808|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20809|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20810|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20811|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20812|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20813|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20814|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20815|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20816|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20817|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20818|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20819|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20820|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20821|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20822|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20823|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20824|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20825|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20826|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20827|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20828|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20829|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20830|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20831|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20832|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20833|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20834|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20872|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20835|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
21177|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
20836|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20837|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20838|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20839|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20840|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20841|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20842|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20843|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20844|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20845|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20846|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20847|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20848|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20849|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20850|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20851|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20852|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20853|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20854|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20855|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20856|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20857|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20858|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20859|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20860|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20861|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20862|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20863|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20864|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20865|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20866|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20867|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20868|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20869|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20870|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20871|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20873|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
21178|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
20874|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20875|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20876|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20877|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20878|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20879|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20880|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20881|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20882|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20883|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20884|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20885|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20886|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20887|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20888|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20889|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20890|NCT02359045|E7|Reported Event|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
20891|NCT02359045|E6|Reported Event|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
20892|NCT02359045|E5|Reported Event|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
20893|NCT02359045|E4|Reported Event|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
20894|NCT02359045|E3|Reported Event|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
20895|NCT02359045|E2|Reported Event|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
20896|NCT02359045|E1|Reported Event|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
20897|NCT02358876|B1|Baseline|Participants|
20898|NCT02358876|P1|Participant Flow|Participants|
20899|NCT02358876|O1|Outcome|Participants|
20900|NCT02358876|E1|Reported Event|Participants|
20901|NCT02358668|B4|Baseline|Total|Total of all reporting groups
20902|NCT02358668|B3|Baseline|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20903|NCT02358668|B2|Baseline|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20904|NCT02358668|B1|Baseline|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20905|NCT02358668|P3|Participant Flow|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20906|NCT02358668|P2|Participant Flow|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20907|NCT02358668|P1|Participant Flow|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20908|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20909|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21099|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21100|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21179|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21180|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
20910|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20911|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20912|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20913|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20914|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20915|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20916|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20917|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20918|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20919|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20920|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20921|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20922|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20923|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20924|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20925|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20926|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20927|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20928|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20929|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20930|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20931|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20932|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20933|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20934|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20935|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20936|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21101|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21102|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
20937|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20938|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20939|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20940|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20941|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20942|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20943|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20944|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20945|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20946|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20947|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20948|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20949|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20950|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20951|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20952|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20953|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20954|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20955|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20956|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20957|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20958|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20959|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20960|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20961|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20962|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20963|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21103|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21104|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
20964|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20965|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20966|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20967|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20968|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20969|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20970|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20971|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20972|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20973|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20974|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20975|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20976|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20977|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20978|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20979|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20980|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20981|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20982|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20983|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20984|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20985|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20986|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20987|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20988|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20989|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20990|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21105|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21106|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
20991|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20992|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20993|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20994|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20995|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20996|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20997|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
20998|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
20999|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21000|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21001|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21002|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21003|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21004|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21005|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21006|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21007|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21008|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21009|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21010|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21011|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21012|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21013|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21014|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21015|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21016|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21017|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21107|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21108|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21018|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21019|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21020|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21021|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21022|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21023|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21024|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21025|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21026|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21027|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21028|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21029|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21030|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21031|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21032|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21033|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21034|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21035|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21036|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21037|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21038|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21039|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21040|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21041|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21042|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21043|NCT02358668|E3|Reported Event|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo"
21044|NCT02358668|E2|Reported Event|BTI320 8 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21109|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21110|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21045|NCT02358668|E1|Reported Event|BTI320 4 Grams|"three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
21046|NCT02358044|B3|Baseline|Total|Total of all reporting groups
21047|NCT02358044|B2|Baseline|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
21048|NCT02358044|B1|Baseline|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
21049|NCT02358044|P2|Participant Flow|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
21050|NCT02358044|P1|Participant Flow|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
21051|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
21052|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
21053|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
21054|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
21055|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
21056|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
21057|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
21058|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
21059|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
21060|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
21061|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
21062|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
21063|NCT02358044|E2|Reported Event|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
21064|NCT02358044|E1|Reported Event|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
21065|NCT02357940|B3|Baseline|Total|Total of all reporting groups
21066|NCT02357940|B2|Baseline|Babies|Babies - 1% Colloidal Oatmeal Balm
21067|NCT02357940|B1|Baseline|Adults|Adults - 1% Colloidal Oatmeal Balm
21068|NCT02357940|P2|Participant Flow|Babies|Babies - 1% Colloidal Oatmeal Balm
21069|NCT02357940|P1|Participant Flow|Adults|Adults - 1% Colloidal Oatmeal Balm
21070|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21071|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21072|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21073|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21074|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21075|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21076|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21077|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21078|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21079|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21080|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21081|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21082|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21083|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21084|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21085|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21086|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21087|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21088|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21089|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21090|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21091|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21092|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21093|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21094|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21095|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21096|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21097|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
21098|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
21190|NCT02357940|E2|Reported Event|Babies|Babies - 1% Colloidal Oatmeal Balm
21191|NCT02357940|E1|Reported Event|Adults|Adults - 1% Colloidal Oatmeal Balm
21192|NCT02357485|B1|Baseline|Treatment Arm|Single injection of ADSC
21193|NCT02357485|P1|Participant Flow|Treatment Arm|Single injection of Adipose-derived Stromal Cells (ADSC) into intra-articular space of the knee
21194|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
21195|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
21196|NCT02357485|O1|Outcome|Treatment Arm|"Single injection of ADSC
ADSC: Single injection of ADSC"
21197|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
21198|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
21199|NCT02357485|E1|Reported Event|Treatment Arm|Single injection of ADSC
21200|NCT02357342|B3|Baseline|Total|Total of all reporting groups
21201|NCT02357342|B2|Baseline|Standard of Care Intravitreal antiVEGF|"antiVEGF intravitreal injections
Standard of Care intravitreal injections of antiVEGF: intravitreal injections of antiVEGF"
21202|NCT02357342|B1|Baseline|Sirolimus|"Intravitreal Sirolimus
Sirolimus: intravitreal injection"
21203|NCT02357342|P2|Participant Flow|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
21204|NCT02357342|P1|Participant Flow|Sirolimus|"Intravitreal Sirolimus
Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
21205|NCT02357342|O2|Outcome|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
21206|NCT02357342|O1|Outcome|Sirolimus|"Intravitreal Sirolimus
Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
21207|NCT02357342|O2|Outcome|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
21208|NCT02357342|O1|Outcome|Sirolimus|"Intravitreal Sirolimus
Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
21209|NCT02357342|O2|Outcome|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
21210|NCT02357342|O1|Outcome|Sirolimus|"Intravitreal Sirolimus
Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
21211|NCT02357342|E2|Reported Event|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
21212|NCT02357342|E1|Reported Event|Sirolimus|"Intravitreal Sirolimus
Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
21213|NCT02357264|B3|Baseline|Total|Total of all reporting groups
21214|NCT02357264|B2|Baseline|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia
Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
21215|NCT02357264|B1|Baseline|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia
Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
21216|NCT02357264|P2|Participant Flow|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia
Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
21217|NCT02357264|P1|Participant Flow|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia
Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
21218|NCT02357264|O2|Outcome|Pregnant Females With Suspicion of Pre-eclampsia|Pregnant females who the OB/GYN physician has suspicion that may have pre-eclampsia
21219|NCT02357264|O1|Outcome|Pregnant Females Without Pre-Eclampsia|Pregnant Females who the OB/GYN physician suspects do not have pre-eclampsia
21220|NCT02357264|E2|Reported Event|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia
Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
21221|NCT02357264|E1|Reported Event|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia
Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
21222|NCT02356900|B3|Baseline|Total|Total of all reporting groups
21223|NCT02356900|B2|Baseline|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
21224|NCT02356900|B1|Baseline|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.
Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
21225|NCT02356900|P2|Participant Flow|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
21329|NCT02354833|O1|Outcome|Phenylephrine|Cardiac Output as recorded by a non-invasive hemodynamic monitor
21226|NCT02356900|P1|Participant Flow|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.
Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
21227|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
21228|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.
Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
21229|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
21230|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.
Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
21231|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
21232|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.
Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
21233|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
21234|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.
Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
21235|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
21236|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.
Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
21237|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
21238|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.
Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
21239|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
21240|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.
Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
21241|NCT02356900|E2|Reported Event|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
21242|NCT02356900|E1|Reported Event|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.
Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
21243|NCT02356588|B3|Baseline|Total|Total of all reporting groups
21292|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
minocycline: Periocline dental ointment
surface and root planning: surface and root planning"
41459|NCT02151994|E3|Reported Event|25 mg (SAD)|SAD period
21244|NCT02356588|B2|Baseline|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21245|NCT02356588|B1|Baseline|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21246|NCT02356588|P2|Participant Flow|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21247|NCT02356588|P1|Participant Flow|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21248|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21249|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21250|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21251|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21252|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21253|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21254|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21255|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21290|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
surface and root planning: surface and root planning"
21256|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21293|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
surface and root planning: surface and root planning"
21330|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min
Norepinephrine"
21257|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21258|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21259|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21260|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21261|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21262|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21263|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21264|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21265|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21266|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21267|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21268|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21269|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21320|NCT02354833|B2|Baseline|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min
Norepinephrine"
21782|NCT02347072|O3|Outcome|Placebo|Placebo MDI
21270|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21271|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21272|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21273|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21274|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21275|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21276|NCT02356588|E2|Reported Event|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Placebo Tablet"
21277|NCT02356588|E1|Reported Event|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
Sufentanil Tablet 30 mcg"
21278|NCT02355977|B4|Baseline|Total|Total of all reporting groups
21279|NCT02355977|B3|Baseline|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
minocycline: Periocline dental ointment"
21280|NCT02355977|B2|Baseline|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
minocycline: Periocline dental ointment
surface and root planning: surface and root planning"
21281|NCT02355977|B1|Baseline|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
surface and root planning: surface and root planning"
21282|NCT02355977|P3|Participant Flow|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
minocycline: Periocline dental ointment"
21283|NCT02355977|P2|Participant Flow|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
minocycline: Periocline dental ointment
surface and root planning: surface and root planning"
21284|NCT02355977|P1|Participant Flow|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
surface and root planning: surface and root planning"
21285|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
minocycline: Periocline dental ointment"
21286|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
minocycline: Periocline dental ointment
surface and root planning: surface and root planning"
21287|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
surface and root planning: surface and root planning"
21288|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
minocycline: Periocline dental ointment"
21289|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
minocycline: Periocline dental ointment
surface and root planning: surface and root planning"
21534|NCT02350881|O1|Outcome|Overall Cohort|one consecutive series of patients were included
21291|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
minocycline: Periocline dental ointment"
21327|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min
Phenylephrine"
21328|NCT02354833|O2|Outcome|Norepinephrine|Cardiac Output as recorded by a non-invasive hemodynamic monitor
21294|NCT02355977|E3|Reported Event|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
minocycline: Periocline dental ointment"
21295|NCT02355977|E2|Reported Event|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
minocycline: Periocline dental ointment
surface and root planning: surface and root planning"
21296|NCT02355977|E1|Reported Event|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
surface and root planning: surface and root planning"
21297|NCT02355275|B1|Baseline|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
21298|NCT02355275|P1|Participant Flow|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
21299|NCT02355275|O1|Outcome|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
21300|NCT02355275|O1|Outcome|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
21301|NCT02355275|E1|Reported Event|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
21302|NCT02355158|B1|Baseline|Active|"Clonidine hydrochloride topical gel, 0.1%
clonidine hydrochloride topical gel, 0.1%"
21303|NCT02355158|P1|Participant Flow|Active|"Clonidine hydrochloride topical gel, 0.1%
clonidine hydrochloride topical gel, 0.1%"
21304|NCT02355158|O1|Outcome|Active|"Clonidine hydrochloride topical gel, 0.1%
clonidine hydrochloride topical gel, 0.1%"
21305|NCT02355158|E1|Reported Event|Active|"Clonidine hydrochloride topical gel, 0.1%
clonidine hydrochloride topical gel, 0.1%"
21306|NCT02354924|B3|Baseline|Total|Total of all reporting groups
21307|NCT02354924|B2|Baseline|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens
Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21308|NCT02354924|B1|Baseline|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens
Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21309|NCT02354924|P2|Participant Flow|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens
Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21310|NCT02354924|P1|Participant Flow|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens
Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21311|NCT02354924|O2|Outcome|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens
Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21312|NCT02354924|O1|Outcome|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens
Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21313|NCT02354924|O2|Outcome|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens
Biofinity soft contact lens: Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21314|NCT02354924|O1|Outcome|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens
Visco soft contact lens: Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21315|NCT02354924|O2|Outcome|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens
Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21316|NCT02354924|O1|Outcome|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens
Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21317|NCT02354924|E2|Reported Event|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens
Biofinity soft contact lens: Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21318|NCT02354924|E1|Reported Event|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens
Visco soft contact lens: Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
21319|NCT02354833|B3|Baseline|Total|Total of all reporting groups
21321|NCT02354833|B1|Baseline|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min
Phenylephrine"
21322|NCT02354833|P2|Participant Flow|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min
Norepinephrine"
21323|NCT02354833|P1|Participant Flow|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min
Phenylephrine"
21324|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min
Norepinephrine"
21325|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min
Phenylephrine"
21326|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min
Norepinephrine"
21331|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min
Phenylephrine"
21332|NCT02354833|E2|Reported Event|Norepinephrine|Hypotension requiring a rescue bolus
21333|NCT02354833|E1|Reported Event|Phenylephrine|Hypotension requiring a rescue bolus
21334|NCT02354599|B7|Baseline|Total|Total of all reporting groups
21335|NCT02354599|B6|Baseline|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21336|NCT02354599|B5|Baseline|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21337|NCT02354599|B4|Baseline|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21338|NCT02354599|B3|Baseline|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21339|NCT02354599|B2|Baseline|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21340|NCT02354599|B1|Baseline|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21341|NCT02354599|P6|Participant Flow|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21342|NCT02354599|P5|Participant Flow|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21343|NCT02354599|P4|Participant Flow|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21344|NCT02354599|P3|Participant Flow|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21345|NCT02354599|P2|Participant Flow|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21346|NCT02354599|P1|Participant Flow|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21347|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21348|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21349|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21350|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21351|NCT02354599|O6|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21352|NCT02354599|O5|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21353|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21354|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21355|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21356|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21357|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21358|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21359|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21360|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21361|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21362|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21363|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21364|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21365|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21366|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21367|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21368|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21369|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21370|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21371|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21372|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21725|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
21373|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21374|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21375|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21376|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21377|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21378|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21379|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21380|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21381|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21382|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21383|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21384|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21385|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21386|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21387|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21388|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21389|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21390|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21391|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21392|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21393|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21394|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21395|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21396|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21397|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21398|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21399|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21400|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21401|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21402|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21403|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21404|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21405|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21406|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21407|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21408|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21409|NCT02354599|E6|Reported Event|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21410|NCT02354599|E5|Reported Event|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
21411|NCT02354599|E4|Reported Event|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21412|NCT02354599|E3|Reported Event|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21413|NCT02354599|E2|Reported Event|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21414|NCT02354599|E1|Reported Event|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
21415|NCT02353754|B3|Baseline|Total|Total of all reporting groups
21416|NCT02353754|B2|Baseline|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
EXPAREL: 266 mg"
21417|NCT02353754|B1|Baseline|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.
Intrathecal morphine injection: 0.2 mg"
21418|NCT02353754|P2|Participant Flow|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
EXPAREL: 266 mg"
21419|NCT02353754|P1|Participant Flow|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.
Intrathecal morphine injection: 0.2 mg"
21420|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
EXPAREL: 266 mg"
21421|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.
Intrathecal morphine injection: 0.2 mg"
21422|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
EXPAREL: 266 mg"
21423|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.
Intrathecal morphine injection: 0.2 mg"
21424|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
EXPAREL: 266 mg"
21425|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.
Intrathecal morphine injection: 0.2 mg"
21426|NCT02353754|E2|Reported Event|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
EXPAREL: 266 mg"
21427|NCT02353754|E1|Reported Event|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.
Intrathecal morphine injection: 0.2 mg"
21428|NCT02353572|B1|Baseline|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
21429|NCT02353572|P1|Participant Flow|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
21430|NCT02353572|O1|Outcome|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
21431|NCT02353572|E1|Reported Event|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
21446|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:
placebo ultrasound during 5min ;
scapular squeezing in the sitting position (3x10repetitions);
upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21535|NCT02350881|O1|Outcome|Overall Cohort|one consecutive series of patients were included
21536|NCT02350881|E1|Reported Event|Overall Cohort|one consecutive series of patients were included
21618|NCT02349451|O1|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
21432|NCT02353468|B1|Baseline|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.
In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.
MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Lenalidomide: Given PO
Dexamethasone: Given PO or IV"
21449|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:
posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
external rotators strengthening in sidelying positions with load (3x10repetitions);
posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21433|NCT02353468|P1|Participant Flow|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.
In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.
MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Lenalidomide: Given PO
Dexamethasone: Given PO or IV"
21434|NCT02353468|O1|Outcome|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.
In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.
MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Lenalidomide: Given PO
Dexamethasone: Given PO or IV"
21435|NCT02353468|E1|Reported Event|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.
In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.
MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Lenalidomide: Given PO
Dexamethasone: Given PO or IV"
21436|NCT02353442|B3|Baseline|Total|Total of all reporting groups
21437|NCT02353442|B2|Baseline|Experimental Group|"This group will perform during 4 weeks:
posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
external rotators strengthening in sidelying positions with load (3x10repetitions);
posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21438|NCT02353442|B1|Baseline|Control Group|"This group will perform during 4 weeks:
placebo ultrasound during 5min ;
scapular squeezing in the sitting position (3x10repetitions);
upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21439|NCT02353442|P2|Participant Flow|Experimental Group|"This group will perform during 4 weeks:
posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
external rotators strengthening in sidelying positions with load (3x10repetitions);
posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21440|NCT02353442|P1|Participant Flow|Control Group|"This group will perform during 4 weeks:
placebo ultrasound during 5min ;
scapular squeezing in the sitting position (3x10repetitions);
upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21441|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:
posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
external rotators strengthening in sidelying positions with load (3x10repetitions);
posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21442|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:
placebo ultrasound during 5min ;
scapular squeezing in the sitting position (3x10repetitions);
upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21443|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:
posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
external rotators strengthening in sidelying positions with load (3x10repetitions);
posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21444|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:
placebo ultrasound during 5min ;
scapular squeezing in the sitting position (3x10repetitions);
upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21445|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:
posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
external rotators strengthening in sidelying positions with load (3x10repetitions);
posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21487|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
21619|NCT02349451|O3|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
21447|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:
posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
external rotators strengthening in sidelying positions with load (3x10repetitions);
posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21448|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:
placebo ultrasound during 5min ;
scapular squeezing in the sitting position (3x10repetitions);
upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21450|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:
placebo ultrasound during 5min ;
scapular squeezing in the sitting position (3x10repetitions);
upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21451|NCT02353442|E2|Reported Event|Experimental Group|"This group will perform during 4 weeks:
posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
external rotators strengthening in sidelying positions with load (3x10repetitions);
posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21452|NCT02353442|E1|Reported Event|Control Group|"This group will perform during 4 weeks:
placebo ultrasound during 5min ;
scapular squeezing in the sitting position (3x10repetitions);
upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
21453|NCT02352779|B4|Baseline|Total|Total of all reporting groups
21454|NCT02352779|B3|Baseline|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21455|NCT02352779|B2|Baseline|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Omega-3 Fatty Acid: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21456|NCT02352779|B1|Baseline|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Omega-3 Fatty Acid: Given PO
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21457|NCT02352779|P3|Participant Flow|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21458|NCT02352779|P2|Participant Flow|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Omega-3 Fatty Acid: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21459|NCT02352779|P1|Participant Flow|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Omega-3 Fatty Acid: Given PO
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21460|NCT02352779|O3|Outcome|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21461|NCT02352779|O2|Outcome|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Omega-3 Fatty Acid: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21462|NCT02352779|O1|Outcome|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Omega-3 Fatty Acid: Given PO
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21463|NCT02352779|E3|Reported Event|Arm III (Placebo)|"Patients receive placebo PO BID for 6 weeks.
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21464|NCT02352779|E2|Reported Event|Arm II (High-dose Omega-3 Fatty Acid)|"Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Omega-3 Fatty Acid: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21465|NCT02352779|E1|Reported Event|Arm I (Low-dose Omega-3 Fatty Acid)|"Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Omega-3 Fatty Acid: Given PO
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies"
21466|NCT02352298|B1|Baseline|Dario and Yellow Springs Instrument|Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System and the Yellow Springs Instrument for comparison.
21467|NCT02352298|P1|Participant Flow|Dario and Yellow Springs Instrument|Blood is obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System, blood glucose level is then also analyzed on the Yellow Springs Instrument for comparison.
21468|NCT02352298|O1|Outcome|Dario Blood Glucose Monitoring System|"Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System
Dario Blood Glucose Monitoring System: Fingerstick to obtain blood sample for analysis with the Dario BGMS"
21469|NCT02352298|E2|Reported Event|YSI STAT|"Blood obtained via fingerstick and blood glucose level is tested on the YSI STAT for comparison to the results obtained with the Dario Blood Glucose Monitoring System
YSI Analyzer: Fingerstick to obtain blood sample for analysis with YSI"
21470|NCT02352298|E1|Reported Event|Dario Blood Glucose Monitoring System|"Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System
Dario Blood Glucose Monitoring System: Fingerstick to obtain blood sample for analysis with the Dario BGMS"
21471|NCT02351934|B3|Baseline|Total|Total of all reporting groups
21531|NCT02350881|O3|Outcome|Severe|Number of patients reporting a severe pain
21472|NCT02351934|B2|Baseline|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
21473|NCT02351934|B1|Baseline|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
21490|NCT02351817|B1|Baseline|Overall Study Population|The investigation is a cross-over investigation therefore baseline data is presented for the overall population
21795|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
21474|NCT02351934|P2|Participant Flow|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
21475|NCT02351934|P1|Participant Flow|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
21476|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
21477|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
21478|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
21479|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
21480|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
21481|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
21482|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
21483|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
21484|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
21485|NCT02351934|O1|Outcome|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
21486|NCT02351934|O2|Outcome|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
21532|NCT02350881|O2|Outcome|Moderate|Number of patients reporting a moderate pain
21488|NCT02351934|E2|Reported Event|Enhanced Recovery After Surgery (ERAS)|ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
21489|NCT02351934|E1|Reported Event|Furosemide + Enhanced Recovery After Surgery (ERAS)|Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
21491|NCT02351817|P2|Participant Flow|Baseline - Test B - Test A|"First each subject tests baseline product, then Test B and finally Test A.
Baseline product: the subject's usual product
Test A: A newly developed 1-piece, open ostomy appliance for collecting feces
Test B: A newly developed 1-piece, open ostomy appliance for collecting feces"
21492|NCT02351817|P1|Participant Flow|Baseline - Test A - Test B|"First each subject tests baseline product, then Test A and finally Test B.
Baseline product: the subject's usual product
Test A: A newly developed 1-piece, open ostomy appliance for collecting feces
Test B: A newly developed 1-piece, open ostomy appliance for collecting feces"
21493|NCT02351817|O2|Outcome|Test B|How many subjects preferred Test B over own product
21494|NCT02351817|O1|Outcome|Test A|How many subjects preferred Test A over own product
21495|NCT02351817|E3|Reported Event|Test B|Adverse events reported by subjects testing Test B
21496|NCT02351817|E2|Reported Event|Test A|Adverse events reported by subjects testing Test A
21497|NCT02351817|E1|Reported Event|Baseline|Adverse events reported by subjects testing Own product
21498|NCT02351505|B1|Baseline|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
21499|NCT02351505|P1|Participant Flow|Arm A: Selinexor (KPT-330)|"Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pharmacological Study: Correlative studies"
21500|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
21501|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
21502|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
21503|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
21504|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
21505|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
21506|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
21507|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|"Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pharmacological Study: Correlative studies"
21508|NCT02351505|E1|Reported Event|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
21509|NCT02350881|B1|Baseline|Overall Cohort|one consecutive series of patients were included
21510|NCT02350881|P1|Participant Flow|Overall Cohort|one consecutive series of patients were included
21511|NCT02350881|O2|Outcome|Revisions|Percentage of feet reoperated for implant ablation
21512|NCT02350881|O1|Outcome|Survival|Percentage of feet with implant still in place
21513|NCT02350881|O4|Outcome|Greater|Number of patients who declared a worsening of pain at rest postoperatively
21514|NCT02350881|O3|Outcome|Same|Number of patients who declared no improvement in pain at rest postoperatively
21515|NCT02350881|O2|Outcome|Less|Number of patients who declared a slight improvement of pain at rest postoperatively
21516|NCT02350881|O1|Outcome|Disappeared|Number of patients who declared an absence of pain at rest postoperatively
21517|NCT02350881|O4|Outcome|Greater|Number of patients who declared a worsening of pain during walking postoperatively
21518|NCT02350881|O3|Outcome|Same|Number of patients who declared no improvement in pain during walking postoperatively
21519|NCT02350881|O2|Outcome|Less|Number of patients who declared a slight improvement of pain during walking postoperatively
21520|NCT02350881|O1|Outcome|Disappeared|Number of patients who declared an absence of pain during walking postoperatively
21521|NCT02350881|O3|Outcome|Worsened|Number of patients who declared a worsening of their walking perimeter
21522|NCT02350881|O2|Outcome|Same|Number of patients who declared no improvement in their walking perimeter
21523|NCT02350881|O1|Outcome|Improved|Number of patients who declared an improvement in their walking perimeter
21524|NCT02350881|O3|Outcome|Severe|Number of patients reporting a severe pain
21525|NCT02350881|O2|Outcome|Moderate|umber of patients reporting a moderate pain
21526|NCT02350881|O1|Outcome|Absent|Number of patients reporting no pain
21527|NCT02350881|O2|Outcome|Presence|Number of feet where bone resorption was observed
21528|NCT02350881|O1|Outcome|Absence|Number of feet where no bone resorption was observed
21529|NCT02350881|O2|Outcome|Presence|Number of feet where osteolysis was observed
21530|NCT02350881|O1|Outcome|Absence|Number of feet where no osteolysis was observed
21533|NCT02350881|O1|Outcome|Absent|Number of patients reporting no pain
21537|NCT02350569|B1|Baseline|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
21538|NCT02350569|P1|Participant Flow|LDV/SOF|"LDV/SOF for 1 Day: 3 participants were called for transplant, received one dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg), but had their liver transplant cancelled. All 3 participants were rescreened and 2 were subsequently re-enrolled, transplanted, and continued into the Main Study.
Main Study (LDV/SOF 4 Weeks): One dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 hepatitis C virus (HCV) infection.
Retreatment (LDV/SOF 12 Weeks): Participants who completed treatment in the Main Study and experienced virologic failure had the option to be retreated with LDV/SOF for 12 weeks."
21539|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
21540|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
21541|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
21542|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
21543|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
21544|NCT02350569|E3|Reported Event|Retreatment (LDV/SOF 12 Weeks)|Adverse events reported in this group include 1 participant who completed treatment and experienced virologic failure in the Main Study and was retreated with an additional 12 weeks of LDV/SOF.
21545|NCT02350569|E2|Reported Event|Main Study (LDV/SOF 4 Weeks)|Adverse events reported in this group include participants with chronic genotype 1 HCV infection who received one dose of LDV/SOF (90/400 mg) prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant.
21546|NCT02350569|E1|Reported Event|LDV/SOF for 1 Day|Adverse events reported in this group include participants who received LDV/SOF on Day -1, but did not receive a liver transplant. All 3 participants were rescreened, but only 2 were re-enrolled, transplanted, and received LDV/SOF for 4 weeks.
21547|NCT02349711|B3|Baseline|Total|Total of all reporting groups
21548|NCT02349711|B2|Baseline|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
21549|NCT02349711|B1|Baseline|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
21550|NCT02349711|P2|Participant Flow|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
21551|NCT02349711|P1|Participant Flow|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
21552|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
21553|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
21554|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
21555|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
21556|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
21557|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
21558|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
21780|NCT02347072|B1|Baseline|All Subjects|
21559|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
21560|NCT02349711|E2|Reported Event|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
21561|NCT02349711|E1|Reported Event|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
21562|NCT02349685|B4|Baseline|Total|Total of all reporting groups
21563|NCT02349685|B3|Baseline|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
21564|NCT02349685|B2|Baseline|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.
14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
21565|NCT02349685|B1|Baseline|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d
14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
21566|NCT02349685|P3|Participant Flow|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
21567|NCT02349685|P2|Participant Flow|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.
14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
21568|NCT02349685|P1|Participant Flow|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d
14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
21569|NCT02349685|O3|Outcome|14 Day Tailored Therapy Group|"based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
H. pylori culture and antimicrobial susceptibility test: Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute."
21570|NCT02349685|O2|Outcome|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.
14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
21571|NCT02349685|O1|Outcome|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d
14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
21572|NCT02349685|O3|Outcome|14 Day Tailored Therapy Group|"based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
H. pylori culture and antimicrobial susceptibility test: Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute."
21573|NCT02349685|O2|Outcome|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.
14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
21574|NCT02349685|O1|Outcome|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d
14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
21575|NCT02349685|E3|Reported Event|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
21576|NCT02349685|E2|Reported Event|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.
14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
21783|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
21577|NCT02349685|E1|Reported Event|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d
14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
21624|NCT02349451|E2|Reported Event|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
21625|NCT02349451|E1|Reported Event|Placebo EW|Double-blind placebo administered EW for 12 weeks
21626|NCT02349438|B1|Baseline|Dispensed|All subjects that were dispensed at least 1 study lens during the course of the study.
21578|NCT02349542|B1|Baseline|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.
Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
21579|NCT02349542|P1|Participant Flow|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.
Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
21580|NCT02349542|O1|Outcome|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.
Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
21581|NCT02349542|O1|Outcome|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.
Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
21582|NCT02349542|E1|Reported Event|Liposomal Bupivacaine|"Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.
Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site."
21583|NCT02349451|B5|Baseline|Total|Total of all reporting groups
21584|NCT02349451|B4|Baseline|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
21585|NCT02349451|B3|Baseline|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
21586|NCT02349451|B2|Baseline|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
21587|NCT02349451|B1|Baseline|Placebo EW|Double-blind placebo administered EW for 12 weeks
21588|NCT02349451|P4|Participant Flow|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
21589|NCT02349451|P3|Participant Flow|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
21590|NCT02349451|P2|Participant Flow|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks
21591|NCT02349451|P1|Participant Flow|Placebo EW|Double-blind placebo administered every week (EW) for 12 weeks
21592|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
21593|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
21594|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
21595|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
21596|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
21597|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
21598|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
21599|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
21600|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
21601|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
21602|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
21603|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
21604|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
21605|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
21606|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
21607|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
21608|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
21609|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
21610|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
21611|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
21612|NCT02349451|O4|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
21613|NCT02349451|O3|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
21614|NCT02349451|O2|Outcome|Adalimumab 40 mg EOW|Double-blind adalimumab 40 mg administered EOW for 12 weeks
21615|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
21616|NCT02349451|O3|Outcome|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
21617|NCT02349451|O2|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
21620|NCT02349451|O2|Outcome|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
21621|NCT02349451|O1|Outcome|Placebo EW|Double-blind placebo administered EW for 12 weeks
21622|NCT02349451|E4|Reported Event|ABT-122 240 mg EW|Double-blind ABT-122 240 mg administered EW for 12 weeks
21623|NCT02349451|E3|Reported Event|ABT-122 120 mg EW|Double-blind ABT-122 120 mg administered EW for 12 weeks
21627|NCT02349438|P2|Participant Flow|Lotrafilcon B/Senofilcon A|Subjects that were randomized to receive the lotrafilcon B lens first and then to receive the senofilcon A lens.
21628|NCT02349438|P1|Participant Flow|Senofilcon A/Lotrafilcon B|Subjects that were randomized to receive the senofilcon A lens first and then to receive the lotrafilcon B lens.
21629|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
21630|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
21631|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
21632|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
21633|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
21634|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
21635|NCT02349438|E2|Reported Event|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
21636|NCT02349438|E1|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
21637|NCT02349048|B3|Baseline|Total|Total of all reporting groups
21638|NCT02349048|B2|Baseline|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
21639|NCT02349048|B1|Baseline|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
21640|NCT02349048|P2|Participant Flow|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
21641|NCT02349048|P1|Participant Flow|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
21642|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
21643|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
21644|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
21645|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
21646|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
21647|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
21648|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
21649|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
21650|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
21651|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
21652|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
21653|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
21654|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
21655|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
21656|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
21657|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
21658|NCT02349048|E2|Reported Event|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
21659|NCT02349048|E1|Reported Event|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
21660|NCT02348658|B1|Baseline|All Participants|All participants who received either 1 of the two treatment sequences: Sequence 1: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2 or Sequence 2: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
21661|NCT02348658|P2|Participant Flow|TAK-536TCH Fed + TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
21662|NCT02348658|P1|Participant Flow|TAK-536TCH Fasted + TAK-536TCH Fed|TAK-536TCH (20 milligram [mg]/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2.
21663|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21664|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21665|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21666|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21667|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21668|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21669|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21670|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21671|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21672|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21673|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21674|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21675|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21676|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21677|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21678|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21679|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21680|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21681|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21682|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21683|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21684|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21685|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21686|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21781|NCT02347072|P1|Participant Flow|Overall Study|All Subjects Randomized
21687|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21688|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21689|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21690|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21691|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
41460|NCT02151994|E2|Reported Event|5 mg (SAD)|SAD period
21692|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21693|NCT02348658|E2|Reported Event|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
21694|NCT02348658|E1|Reported Event|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
21695|NCT02347488|B1|Baseline|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.
Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
21696|NCT02347488|P1|Participant Flow|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.
Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
21697|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
21698|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
21699|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
21700|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
21701|NCT02347488|O1|Outcome|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.
Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
21702|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
21703|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
21704|NCT02347488|E1|Reported Event|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.
Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery.
Adverse events were not reported per arm because surgery patients were assessed for adverse events after experiencing both methods."
21705|NCT02347176|B5|Baseline|Total|Total of all reporting groups
21706|NCT02347176|B4|Baseline|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21707|NCT02347176|B3|Baseline|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21708|NCT02347176|B2|Baseline|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21709|NCT02347176|B1|Baseline|Placebo|Placebo was administered subcutaneously to participants.
21710|NCT02347176|P4|Participant Flow|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21711|NCT02347176|P3|Participant Flow|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21712|NCT02347176|P2|Participant Flow|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21713|NCT02347176|P1|Participant Flow|Placebo|Placebo was administered subcutaneously to participants.
21714|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21715|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21716|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21717|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
21718|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21719|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21720|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21721|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
21722|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21723|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21724|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21726|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21727|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21728|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21729|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
21730|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21731|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21732|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21733|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
21734|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21735|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21736|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21737|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
21738|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21739|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21740|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21741|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
21742|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21743|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21744|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21745|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
21746|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21747|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21748|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21749|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
21750|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21751|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21752|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21753|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
21754|NCT02347176|E4|Reported Event|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21755|NCT02347176|E3|Reported Event|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21756|NCT02347176|E2|Reported Event|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
21757|NCT02347176|E1|Reported Event|Placebo|Placebo was administered subcutaneously to participants.
21758|NCT02347085|B1|Baseline|All Subjects|
21759|NCT02347085|P1|Participant Flow|Overall Study|All subjects randomized
21760|NCT02347085|O2|Outcome|Placebo|Placebo MDI
21761|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
21762|NCT02347085|O2|Outcome|Placebo|Placebo MDI
21763|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
21764|NCT02347085|O2|Outcome|Placebo|Placebo MDI
21765|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
21766|NCT02347085|O2|Outcome|Placebo|Placebo MDI
21767|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
21768|NCT02347085|O2|Outcome|Placebo|Placebo MDI
21769|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
21770|NCT02347085|O2|Outcome|Placebo|Placebo MDI
21771|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
21772|NCT02347085|O2|Outcome|Placebo|Placebo MDI
21773|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
21774|NCT02347085|O2|Outcome|Placebo|Placebo MDI
21775|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
21776|NCT02347085|O2|Outcome|Placebo|Placebo MDI
21777|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
21778|NCT02347085|E2|Reported Event|Placebo|Placebo MDI
21779|NCT02347085|E1|Reported Event|GFF MDI PT003|GFF MDI 14.4/9.6 µg
21784|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
21785|NCT02347072|O3|Outcome|Placebo|Placebo MDI
21786|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
21787|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
21788|NCT02347072|O3|Outcome|Placebo|Placebo MDI
21789|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
21790|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
21791|NCT02347072|O3|Outcome|Placebo|Placebo MDI
21792|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
21793|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
21794|NCT02347072|O3|Outcome|Placebo|Placebo MDI
21796|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
21797|NCT02347072|O3|Outcome|Placebo|Placebo MDI
21798|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
21799|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
21800|NCT02347072|O3|Outcome|Placebo|Placebo MDI
21801|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
21802|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
21803|NCT02347072|O3|Outcome|Placebo|Placebo MDI
21804|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
21805|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
21806|NCT02347072|O3|Outcome|Placebo|Placebo MDI
21807|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
21808|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
21809|NCT02347072|E3|Reported Event|Placebo|Placebo MDI
21810|NCT02347072|E2|Reported Event|Spiriva Respimat|Spiriva Respimat 5μg
21811|NCT02347072|E1|Reported Event|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
21812|NCT02346877|B3|Baseline|Total|Total of all reporting groups
21813|NCT02346877|B2|Baseline|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
21814|NCT02346877|B1|Baseline|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
21815|NCT02346877|P2|Participant Flow|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
21816|NCT02346877|P1|Participant Flow|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
21817|NCT02346877|O2|Outcome|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
21818|NCT02346877|O1|Outcome|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
21819|NCT02346877|O2|Outcome|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
21820|NCT02346877|O1|Outcome|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
21821|NCT02346877|O2|Outcome|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
21822|NCT02346877|O1|Outcome|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
21823|NCT02346877|E2|Reported Event|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
21824|NCT02346877|E1|Reported Event|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
21825|NCT02346721|B1|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
21943|NCT02343081|B3|Baseline|Total|Total of all reporting groups
21826|NCT02346721|P1|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily
21827|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
21828|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
21829|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL 400/100 mg fixed-dose combination (FDC) tablet orally once daily
21830|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
21831|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
21832|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL 400/100 mg FDC tablet orally once daily
21833|NCT02346721|E1|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
21834|NCT02345720|B1|Baseline|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
21835|NCT02345720|P1|Participant Flow|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
21836|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
21837|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
21838|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
21839|NCT02345720|E1|Reported Event|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
21840|NCT02344745|B3|Baseline|Total|Total of all reporting groups
21841|NCT02344745|B2|Baseline|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21842|NCT02344745|B1|Baseline|Control|"Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21843|NCT02344745|P2|Participant Flow|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21844|NCT02344745|P1|Participant Flow|Control|"Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21845|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21846|NCT02344745|O1|Outcome|Control|"Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21847|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21848|NCT02344745|O1|Outcome|Control|"Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21849|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21850|NCT02344745|O1|Outcome|Control|"Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21851|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21852|NCT02344745|O1|Outcome|Control|"Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21853|NCT02344745|E2|Reported Event|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21854|NCT02344745|E1|Reported Event|Control|"Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
21855|NCT02344407|B4|Baseline|Total|Total of all reporting groups
21856|NCT02344407|B3|Baseline|Placebo (Saline)|Placebo
23393|NCT02329223|E2|Reported Event|IGE025 150 mg|IGE025 150 mg
21857|NCT02344407|B2|Baseline|VSVG-ZEBOV|"VSVG-ZEBOV
VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
21858|NCT02344407|B1|Baseline|ChAd3-EBO Z|"ChAd3-EBO Z
ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
21859|NCT02344407|P3|Participant Flow|Placebo (Saline)|Placebo
21860|NCT02344407|P2|Participant Flow|VSVG-ZEBOV|"VSVG-ZEBOV
VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
21861|NCT02344407|P1|Participant Flow|ChAd3-EBO Z|"ChAd3-EBO Z
ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
21862|NCT02344407|O3|Outcome|Placebo (Saline)|Placebo
21863|NCT02344407|O2|Outcome|VSVG-ZEBOV|"VSVG-ZEBOV
VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
21864|NCT02344407|O1|Outcome|ChAd3-EBO Z|"ChAd3-EBO Z
ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
21865|NCT02344407|O3|Outcome|Placebo (Saline)|Placebo
21866|NCT02344407|O2|Outcome|VSVG-ZEBOV|"VSVG-ZEBOV
VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
21867|NCT02344407|O1|Outcome|ChAd3-EBO Z|"ChAd3-EBO Z
ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
21868|NCT02344407|E3|Reported Event|Placebo (Saline)|Placebo
21869|NCT02344407|E2|Reported Event|VSVG-ZEBOV|"VSVG-ZEBOV
VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)"
21870|NCT02344407|E1|Reported Event|ChAd3-EBO Z|"ChAd3-EBO Z
ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion."
21871|NCT02344342|B5|Baseline|Total|Total of all reporting groups
21872|NCT02344342|B4|Baseline|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No
Flexible Diuretic No"
21873|NCT02344342|B3|Baseline|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No
Flexible Diuretic Yes"
21874|NCT02344342|B2|Baseline|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes
Flexible Diuretic No"
21875|NCT02344342|B1|Baseline|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes
Flexible Diuretic Yes"
21876|NCT02344342|P4|Participant Flow|Health Buddy No and Flexible Diuretic No|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.
Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
21877|NCT02344342|P3|Participant Flow|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
21878|NCT02344342|P2|Participant Flow|Health Buddy Yes and Flexible Diuretic Regimen No|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
21879|NCT02344342|P1|Participant Flow|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
21880|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.
Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
21881|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
21882|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic Regimen No|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
21883|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
21884|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No
Flexible Diuretic No"
21885|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No
Flexible Diuretic Yes"
21886|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes
Flexible Diuretic No"
21887|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes
Flexible Diuretic Yes"
21888|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No
Flexible Diuretic No"
23394|NCT02329223|E1|Reported Event|IGE025 300 mg|IGE025 300 mg
21889|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No
Flexible Diuretic Yes"
21890|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes
Flexible Diuretic No"
21891|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes
Flexible Diuretic Yes"
21892|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No
Flexible Diuretic No"
21893|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No
Flexible Diuretic Yes"
21894|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes
Flexible Diuretic No"
21895|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes
Flexible Diuretic Yes"
21979|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21896|NCT02344342|E4|Reported Event|Health Buddy Web NO /Flexible Diuretic NO|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.
Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
21897|NCT02344342|E3|Reported Event|Health Buddy Web NO/Flexible Diuretic YES|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
21898|NCT02344342|E2|Reported Event|Health Buddy Web YES /Flexible Diuretic NO|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
21899|NCT02344342|E1|Reported Event|Health Buddy Web YES/Flexible Diuretic YES|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
21900|NCT02343380|B3|Baseline|Total|Total of all reporting groups
21901|NCT02343380|B2|Baseline|Evening-first, Then Morning|"calorimetric exam after a standard meal
calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
21902|NCT02343380|B1|Baseline|Morning-first, Then Evening|"calorimetric exam after a standard meal
calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
21903|NCT02343380|P2|Participant Flow|Evening-first, Then Morning|"calorimetric exam after a standard meal
calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
21904|NCT02343380|P1|Participant Flow|Morning-first, Then Evening|"calorimetric exam after a standard meal
calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
21905|NCT02343380|O2|Outcome|Evening|"Variation in morning triglyceride and free fatty acid (FFA) Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm
The metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
21906|NCT02343380|O1|Outcome|Morning|"Variation in morning triglyceride and free fatty acid (FFA) Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 am.
The metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
21907|NCT02343380|O2|Outcome|Evening|Variation in morning glucose and insulin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm
21908|NCT02343380|O1|Outcome|Morning|Variation in morning glucose and insulin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00
21909|NCT02343380|O2|Outcome|Evening|"calorimetric exam after a standard meal
calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
21910|NCT02343380|O1|Outcome|Morning|"calorimetric exam after a standard meal
calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
21911|NCT02343380|E2|Reported Event|Evening|"calorimetric exam after a standard meal
calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
21912|NCT02343380|E1|Reported Event|Morning|"calorimetric exam after a standard meal
calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
21913|NCT02343159|B4|Baseline|Total|Total of all reporting groups
21914|NCT02343159|B3|Baseline|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21915|NCT02343159|B2|Baseline|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
22124|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
21916|NCT02343159|B1|Baseline|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21917|NCT02343159|P3|Participant Flow|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21918|NCT02343159|P2|Participant Flow|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
22135|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
21919|NCT02343159|P1|Participant Flow|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21920|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21921|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21922|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21923|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21924|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21925|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21926|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21927|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21928|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21929|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21930|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21931|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21932|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21933|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21934|NCT02343159|O2|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21935|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21936|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21937|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21938|NCT02343159|O2|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21939|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21940|NCT02343159|E3|Reported Event|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21941|NCT02343159|E2|Reported Event|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21942|NCT02343159|E1|Reported Event|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
21944|NCT02343081|B2|Baseline|Dralitem, Then Temodal|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A.(Dralitem®). All patients were under fasting conditions two hours before and after each drug administration.
21978|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
41461|NCT02151994|E1|Reported Event|Placebo (SAD)|SAD period
21945|NCT02343081|B1|Baseline|Temodal, Then Dralitem|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A. (Dralitem®).All patients were under fasting conditions two hours before and after each drug administration.
21946|NCT02343081|P2|Participant Flow|Dralitem, Then Temodal|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A.(Dralitem®). All patients were under fasting conditions two hours before and after each drug administration.
21947|NCT02343081|P1|Participant Flow|Temodal, Then Dralitem|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A. (Dralitem®).All patients were under fasting conditions two hours before and after each drug administration.
21948|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose
Temozolomide"
21949|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
Temozolomide"
21950|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose
Temozolomide"
21951|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
Temozolomide"
21952|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose
Temozolomide"
21953|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
Temozolomide"
21954|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose
Temozolomide"
21955|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
Temozolomide"
21956|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose
Temozolomide"
21957|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
Temozolomide"
21958|NCT02343081|E2|Reported Event|Dralitem|Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose.
21959|NCT02343081|E1|Reported Event|Temodal|Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
21960|NCT02341859|B1|Baseline|Overall Participant Flow|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens
narafilcon A: contact lens"
21961|NCT02341859|P2|Participant Flow|Stenfilcon A/Narafilcon A, Then Stenfilcon A/Delefilcon A|"Participants randomized wear the stenfilcon A and narafilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and delefilcon A lens pair contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens
delefilcon A: contact lens"
21962|NCT02341859|P1|Participant Flow|Stenfilcon A/Delefilcon A, Then Stenfilcon A/Narafilcon A|"Participants randomized wear the stenfilcon A and delefilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and narafilcon A lens pair contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens
narafilcon A: contact lens"
21963|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21964|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21965|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21966|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21967|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21968|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21969|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21970|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21971|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21972|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21973|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21974|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22125|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
21975|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21976|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21977|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21980|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21981|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21982|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21983|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21984|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21985|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21986|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21987|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21988|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21989|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21990|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21991|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21992|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21993|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21994|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21995|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21996|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
21997|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21998|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
21999|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22000|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22001|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22002|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22003|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22004|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22005|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22006|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22007|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22008|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22009|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22010|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
23395|NCT02329015|B3|Baseline|Total|Total of all reporting groups
22011|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22012|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22013|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22014|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22015|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22016|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22017|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22018|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22019|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22020|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22021|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22022|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22023|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22024|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22025|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22026|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22027|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22028|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22029|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22030|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22031|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22032|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22033|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22034|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22035|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22036|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22037|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22038|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22039|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22040|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22041|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22042|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22043|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22044|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22045|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22046|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
23494|NCT02327117|E2|Reported Event|Normal Saline|Normal saline
22047|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22048|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22049|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22050|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22051|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22052|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22053|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22054|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22055|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22056|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22057|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22058|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22059|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22060|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22061|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22062|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22063|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22064|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22065|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22066|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22067|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22068|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22069|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22070|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22071|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22072|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22073|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22074|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22075|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22076|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22077|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22078|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22079|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22080|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22081|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22082|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
23495|NCT02327117|E1|Reported Event|Tranexamic Acid|Tranexamic Acid
22083|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22084|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22085|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22086|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22087|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22088|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22089|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22090|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22091|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22092|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22093|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22094|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22095|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22096|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22097|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22098|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22099|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22100|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22101|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22102|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22103|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22104|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22105|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22106|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22107|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.
stenfilcon A: contact lens
narafilcon A: contact lens"
22108|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22109|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22110|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A: contact lens
delefilcon A: contact lens"
22111|NCT02341859|E3|Reported Event|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
narafilcon A: contact lens"
22112|NCT02341859|E2|Reported Event|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens"
22113|NCT02341859|E1|Reported Event|Stenfilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens
narafilcon A: contact lens"
22114|NCT02342704|B3|Baseline|Total|Total of all reporting groups
22115|NCT02342704|B2|Baseline|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22116|NCT02342704|B1|Baseline|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22117|NCT02342704|P2|Participant Flow|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22118|NCT02342704|P1|Participant Flow|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22119|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22120|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22121|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22122|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22123|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22126|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22127|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22128|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22129|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22130|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22131|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22132|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22133|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22134|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22136|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22137|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22138|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22139|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22140|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22141|NCT02342704|E2|Reported Event|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
22142|NCT02342704|E1|Reported Event|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
22143|NCT02342561|B1|Baseline|Intervention Knees (Draped Knees) and Control Knees (No-draped|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.
Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.
The knee that is not drape is left uncovered during the intervention."
22144|NCT02342561|P1|Participant Flow|Intervention Knee (Drape Side) and Control Knee (No Drape Side|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.
Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.
The control knee that is not drape is left uncovered during the intervention."
22145|NCT02342561|O2|Outcome|Control Knees (No-drape Side)|The knees were not drape were left uncovered during the intervention.
22146|NCT02342561|O1|Outcome|Intervention Knees (Drape Side)|"One knee of the patient were randomly selected to be draped with an Ioban 2 incision drape.
Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
22147|NCT02342561|O2|Outcome|Control Knee (No-drape Knees)|The knee that is not drape is left uncovered during the intervention.
22148|NCT02342561|O1|Outcome|Intervention Knee (Draped Knees)|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.
Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
22149|NCT02342561|E2|Reported Event|Control Knees|The knees that were not drape is left uncovered during the intervention.
22150|NCT02342561|E1|Reported Event|Intervention Knees|"One knee of the patient were randomly selected to be drape with an Ioban 2 incision drape.
Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
22151|NCT02342535|B1|Baseline|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.
The participant's children between the ages of 6 and 14 years will participate in the martial arts and yoga class with their mothers.
Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
22152|NCT02342535|P1|Participant Flow|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.
The participant's children between the ages of 6 and 14 years will participate in the martial arts class with the mothers.
Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
22153|NCT02342535|O1|Outcome|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.
The participant's children between the ages of 6 and 14 years will participate in the kids exercise class with their mothers.
Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
22154|NCT02342535|E1|Reported Event|Physical Activity Intervention|"Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.
The participant's children between the ages of 6 and 14 years will participate in the kids exercise class with their mothers.
Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children."
22155|NCT02342418|B3|Baseline|Total|Total of all reporting groups
22156|NCT02342418|B2|Baseline|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
22157|NCT02342418|B1|Baseline|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
22158|NCT02342418|P2|Participant Flow|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
22784|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22159|NCT02342418|P1|Participant Flow|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
22160|NCT02342418|O2|Outcome|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
41462|NCT02151981|B3|Baseline|Total|Total of all reporting groups
22161|NCT02342418|O1|Outcome|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
22162|NCT02342418|O2|Outcome|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
22163|NCT02342418|O1|Outcome|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
22164|NCT02342418|E2|Reported Event|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
22165|NCT02342418|E1|Reported Event|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
22166|NCT02342288|B3|Baseline|Total|Total of all reporting groups
22167|NCT02342288|B2|Baseline|Head in Neutral Position|"Head in neutral position
Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
22168|NCT02342288|B1|Baseline|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs
Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
22169|NCT02342288|P2|Participant Flow|Head in Neutral Position|"Head in neutral position
Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
22170|NCT02342288|P1|Participant Flow|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs
Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
22171|NCT02342288|O2|Outcome|Head in Neutral Position|"Head in neutral position
Head in neutral position: Five minutes after turning prone, an IOP measurement was obtained. After 5 minutes an IOP measurement was taken. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
22189|NCT02342197|O2|Outcome|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's
Decapeptyl: half the dose of Gn agonist"
22190|NCT02342197|O1|Outcome|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.
Decapeptyl: half the dose of Gn agonist"
25821|NCT02305329|E2|Reported Event|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
22172|NCT02342288|O1|Outcome|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs
Head raised 10 degrees: Five minutes after turning prone, an IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes an IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
22311|NCT02339831|P1|Participant Flow|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22312|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
41612|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
22173|NCT02342288|E2|Reported Event|Head in Neutral Position|"Head in neutral position
Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
22174|NCT02342288|E1|Reported Event|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs
Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
22175|NCT02342223|B1|Baseline|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.
All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
22176|NCT02342223|P1|Participant Flow|Voluma Treatment of HIV Facial Lipoatrophy|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.
All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
22177|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.
All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
22178|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.
All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
22179|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.
All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
22180|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.
All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
22181|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.
All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
22182|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.
All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
22183|NCT02342223|E1|Reported Event|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.
All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
22184|NCT02342197|B3|Baseline|Total|Total of all reporting groups
22185|NCT02342197|B2|Baseline|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's
Decapeptyl: half the dose of Gn agonist"
22186|NCT02342197|B1|Baseline|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.
Decapeptyl: half the dose of Gn agonist"
22187|NCT02342197|P2|Participant Flow|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's
Decapeptyl: half the dose of Gn agonist"
22188|NCT02342197|P1|Participant Flow|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.
Decapeptyl: half the dose of Gn agonist"
22292|NCT02340000|O3|Outcome|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
22191|NCT02342197|E2|Reported Event|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's
Decapeptyl: half the dose of Gn agonist"
22192|NCT02342197|E1|Reported Event|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.
Decapeptyl: half the dose of Gn agonist"
22732|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22193|NCT02341482|B1|Baseline|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
22194|NCT02341482|P1|Participant Flow|All Subjects|PF-04958242 0.10 milligram (mg) loading dose was administered orally twice daily (BID) on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), once daily (QD).
22195|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
22196|NCT02341482|O3|Outcome|PF-04958242 0.1 mg|All participants who received PF-04958242 0.1 mg BID orally.
22197|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
22198|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
22199|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
22200|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
22201|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
22202|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
22203|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
22204|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
22205|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
22206|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
22207|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
22208|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
22209|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
22210|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
22211|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
22212|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
22213|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
22214|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
22215|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
22216|NCT02341482|E3|Reported Event|PF-04958242 0.025 mg Combined With Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg combined with itraconazole 200 mg orally.
22217|NCT02341482|E2|Reported Event|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
22218|NCT02341482|E1|Reported Event|PF-04958242 0.1 mg|All participants who received PF-04958242 0.1 mg BID orally.
22219|NCT02341144|B3|Baseline|Total|Total of all reporting groups
22293|NCT02340000|O2|Outcome|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
22294|NCT02340000|O1|Outcome|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
22295|NCT02340000|O4|Outcome|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
22220|NCT02341144|B2|Baseline|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine"
22221|NCT02341144|B1|Baseline|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine"
22222|NCT02341144|P2|Participant Flow|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine"
22223|NCT02341144|P1|Participant Flow|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine"
22224|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine"
22225|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine"
22226|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine"
22227|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine"
22228|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine"
22229|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine"
22230|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine"
22231|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine"
22232|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine"
22296|NCT02340000|O3|Outcome|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
25822|NCT02305329|E1|Reported Event|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
22313|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22314|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
22315|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22233|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine"
22234|NCT02341144|E2|Reported Event|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine"
22235|NCT02341144|E1|Reported Event|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine"
22236|NCT02340338|B8|Baseline|Total|Total of all reporting groups
22237|NCT02340338|B7|Baseline|Dose Group 0|"Control: Al(OH)3 Adjuvant
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22238|NCT02340338|B6|Baseline|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22239|NCT02340338|B5|Baseline|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22240|NCT02340338|B4|Baseline|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22241|NCT02340338|B3|Baseline|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22242|NCT02340338|B2|Baseline|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22297|NCT02340000|O2|Outcome|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
22298|NCT02340000|O1|Outcome|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
22299|NCT02340000|O4|Outcome|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
22300|NCT02340000|O3|Outcome|Standard Dose Time Period 2|Amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
22243|NCT02340338|B1|Baseline|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22244|NCT02340338|P7|Participant Flow|Dose Group 0|"Control: Al(OH)3 Adjuvant
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22245|NCT02340338|P6|Participant Flow|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22246|NCT02340338|P5|Participant Flow|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22247|NCT02340338|P4|Participant Flow|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22248|NCT02340338|P3|Participant Flow|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22249|NCT02340338|P2|Participant Flow|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22250|NCT02340338|P1|Participant Flow|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22301|NCT02340000|O2|Outcome|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
22302|NCT02340000|O1|Outcome|Standard Dose Time Period I|"amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
standard dose amoxicillin/clavulanate: amoxicillin/clavulanate 875/125 + placebo bid x 7 days"
22303|NCT02340000|E4|Reported Event|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
22304|NCT02340000|E3|Reported Event|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
22251|NCT02340338|O7|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22252|NCT02340338|O6|Outcome|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22253|NCT02340338|O5|Outcome|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22254|NCT02340338|O4|Outcome|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22255|NCT02340338|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22256|NCT02340338|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22257|NCT02340338|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22258|NCT02340338|O7|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22259|NCT02340338|O6|Outcome|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22260|NCT02340338|O5|Outcome|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22261|NCT02340338|O4|Outcome|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22262|NCT02340338|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22263|NCT02340338|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22264|NCT02340338|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22265|NCT02340338|E7|Reported Event|Dose Group 0|"Control: Al(OH)3 Adjuvant
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22266|NCT02340338|E6|Reported Event|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22267|NCT02340338|E5|Reported Event|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22305|NCT02340000|E2|Reported Event|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
22306|NCT02340000|E1|Reported Event|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
22308|NCT02339831|B2|Baseline|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
22309|NCT02339831|B1|Baseline|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22310|NCT02339831|P2|Participant Flow|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
22268|NCT02340338|E4|Reported Event|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22269|NCT02340338|E3|Reported Event|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22270|NCT02340338|E2|Reported Event|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22271|NCT02340338|E1|Reported Event|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng
rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized."
22272|NCT02340104|B1|Baseline|All Participants|Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours.
22273|NCT02340104|P1|Participant Flow|Baricitinib|Single oral dose of 4 mg baricitinib on Day 1 and approximately the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours.
22274|NCT02340104|O2|Outcome|[^13C4D3^15N]-Baricitinib IV|Single intravenous (IV) infusion of 4 µg[^13C4D3^15N]-baricitinib over 1.5 hours
22275|NCT02340104|O1|Outcome|Baricitinib Oral Dose|Single oral dose of 4 mg baricitinib
22276|NCT02340104|E1|Reported Event|Baricitinib|Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours
22277|NCT02340000|B3|Baseline|Total|Total of all reporting groups
22278|NCT02340000|B2|Baseline|High Dose|"Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days
high dose amoxicillin/clavulanate: Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days"
22279|NCT02340000|B1|Baseline|Standard Dose|"amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
standard dose amoxicillin/clavulanate: amoxicillin/clavulanate 875/125 + placebo bid x 7 days"
22280|NCT02340000|P2|Participant Flow|High Dose|"Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days
high dose amoxicillin/clavulanate: Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days"
22281|NCT02340000|P1|Participant Flow|Standard Dose|"amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
standard dose amoxicillin/clavulanate: amoxicillin/clavulanate 875/125 + placebo bid x 7 days"
22282|NCT02340000|O4|Outcome|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
22283|NCT02340000|O3|Outcome|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
22284|NCT02340000|O2|Outcome|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
22285|NCT02340000|O1|Outcome|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
22286|NCT02340000|O1|Outcome|Overall|First 231 participants
22287|NCT02340000|O4|Outcome|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
22288|NCT02340000|O3|Outcome|Standard Dose Time Period 2|amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
22289|NCT02340000|O2|Outcome|High Dose Time Period 1|extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
22290|NCT02340000|O1|Outcome|Standard Dose Time Period I|amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
22291|NCT02340000|O4|Outcome|High Dose Time Period 2|immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
22307|NCT02339831|B3|Baseline|Total|Total of all reporting groups
22316|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
22317|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22318|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
22319|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22320|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
22321|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22322|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
22323|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22324|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
22325|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22326|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
22327|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22328|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
22329|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22330|NCT02339831|E2|Reported Event|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
22331|NCT02339831|E1|Reported Event|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
22332|NCT02339246|B3|Baseline|Total|Total of all reporting groups
22333|NCT02339246|B2|Baseline|Prograf vs Astagraf XL vs Envarsus XR|"Prograf capsules twice daily Astagraf XL capsules once daily Envarsus XR tablets once daily
Prograf vs Astagraf XL vs Envarsus XR: Prograf vs Astagraf XL vs Envarsus XR"
22334|NCT02339246|B1|Baseline|Prograf vs Envarsus XR vs Astagraf XL|"Prograft capsules Twice daily Envarsus XR tablets once daily Astagraf XL capsules once daily
Prograf vs Envarsus XR vs Astagraf XL: prograf vs Envarsus XR vs Astagraf XL"
22335|NCT02339246|P3|Participant Flow|Prograf|Prograf capsules twice daily.
22336|NCT02339246|P2|Participant Flow|Astagraf XL|Astagraf XL capsules once daily.
22337|NCT02339246|P1|Participant Flow|Envarsus XR|Envarsus XR tablets once daily.
22338|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
22339|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
22340|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
22341|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
22342|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
22343|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
22344|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
22345|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
22346|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
22347|NCT02339246|E3|Reported Event|Prograf|Prograf capsules twice daily.
22348|NCT02339246|E2|Reported Event|Astagraf XR|Astagraf XR capsules once daily.
22349|NCT02339246|E1|Reported Event|Envarsus XR|Envarsus XR tablets once daily.
22350|NCT02339038|B1|Baseline|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
22351|NCT02339038|P1|Participant Flow|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
22352|NCT02339038|O1|Outcome|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
22353|NCT02339038|E1|Reported Event|Standard of Care|Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
22354|NCT02338713|B1|Baseline|Noncarbonated Water+Calcichew D3|Noncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period.
22355|NCT02338713|P1|Participant Flow|Noncarbonated Water+Calcichew D3|Noncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period.
22356|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
22357|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
25823|NCT02305316|B3|Baseline|Total|Total of all reporting groups
22358|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
22359|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
22360|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
22361|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
22362|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
22363|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
22364|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
22365|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
22366|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
22367|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
22368|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
22369|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
22370|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
22371|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
22372|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
22373|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
22374|NCT02338713|E2|Reported Event|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
22375|NCT02338713|E1|Reported Event|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
22376|NCT02338336|B3|Baseline|Total|Total of all reporting groups
22377|NCT02338336|B2|Baseline|Nowarta110|All combined Nowarta110 doses
22378|NCT02338336|B1|Baseline|Placebo|Matching Placebo
22379|NCT02338336|P4|Participant Flow|Nowarta110 10 Drops|Nowarta110 10 drops administered topically
22380|NCT02338336|P3|Participant Flow|Nowarta110 6 Drops|Nowarta110 6 drops administered topically
22381|NCT02338336|P2|Participant Flow|Norwarta110 3 Drops|Nowarta110 3 drops administered topically
22382|NCT02338336|P1|Participant Flow|Placebo|Matching Placebo
22383|NCT02338336|O2|Outcome|TREATMENT|Nowarta110
22384|NCT02338336|O1|Outcome|Placebo|Matching Placebo
22385|NCT02338336|O2|Outcome|TREATMENT|Nowarta110
22386|NCT02338336|O1|Outcome|Placebo|Matching Placebo
22387|NCT02338336|E2|Reported Event|Nowarta110|All combined Nowarta110 doses
22388|NCT02338336|E1|Reported Event|Placebo|Matching Placebo
22389|NCT02338076|B1|Baseline|Interventional Arm|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22390|NCT02338076|P1|Participant Flow|Interventional Arm|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22391|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22392|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22409|NCT02337959|P2|Participant Flow|Predicate & Investigational - CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
22410|NCT02337959|P1|Participant Flow|Predicate & Investigational - GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
22393|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22492|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22394|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22395|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22396|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22397|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22398|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22399|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22400|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22401|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22402|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22403|NCT02338076|E1|Reported Event|Interventional Arm|"petrolatum application under occlusion
Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
1 well will be empty and the other well will contain petrolatum
Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
22404|NCT02337959|B4|Baseline|Total|Total of all reporting groups
22405|NCT02337959|B3|Baseline|Predicate & Investigational-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detector.
22406|NCT02337959|B2|Baseline|Predicate & Investigational - CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
22407|NCT02337959|B1|Baseline|Predicate & Investigational - GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
22408|NCT02337959|P3|Participant Flow|Predicate & Investigational - Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detector.
26253|NCT02298842|B3|Baseline|Total|Total of all reporting groups
22411|NCT02337959|O1|Outcome|Image Pair Preference|Preference for predicate detector DRX-1 image versus preference for investigational DRX-Plus 3543/C (GOS & CsI) and vice versa.
22412|NCT02337959|O2|Outcome|Investigational|DRX Plus 3543/C (GOS & CsI) Detectors, Cadavers & Live Subjects
22413|NCT02337959|O1|Outcome|Predicate|DRX-1 Detector, Cadavers & Live Subjects
22679|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
22414|NCT02337959|E3|Reported Event|Predicate & Invest.-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
22415|NCT02337959|E2|Reported Event|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
22416|NCT02337959|E1|Reported Event|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
22417|NCT02337062|B3|Baseline|Total|Total of all reporting groups
22418|NCT02337062|B2|Baseline|Placebo + Standard Anti-emetic|"Single dose of IV placebo
Placebo"
22419|NCT02337062|B1|Baseline|APD421 + Standard Anti-emetic|"Single dose of IV APD421
APD421"
22420|NCT02337062|P2|Participant Flow|Placebo + Standard Anti-emetic|Matching Placebo administered as a single, slow push, IV push over one minute at the time of induction anaesthesia given in combination with standard anti-emetic
22421|NCT02337062|P1|Participant Flow|APD421 + Standard Anti-emetic|APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic.
22422|NCT02337062|O2|Outcome|Placebo + Standard Anti-emetic|"Single dose of IV placebo
Placebo"
22423|NCT02337062|O1|Outcome|APD421 + Standard Anti-emetic|"Single dose of IV APD421
APD421"
22424|NCT02337062|E2|Reported Event|Placebo + Standard Anti-emetic|"Single dose of IV placebo
Placebo"
22425|NCT02337062|E1|Reported Event|APD421 + Standard Anti-emetic|"Single dose of IV APD421
APD421"
22426|NCT02336958|B3|Baseline|Total|Total of all reporting groups
22427|NCT02336958|B2|Baseline|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.
pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
22428|NCT02336958|B1|Baseline|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
22429|NCT02336958|P2|Participant Flow|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.
pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
22430|NCT02336958|P1|Participant Flow|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
22431|NCT02336958|O2|Outcome|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.
pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
22432|NCT02336958|O1|Outcome|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
22433|NCT02336958|O2|Outcome|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.
pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
22434|NCT02336958|O1|Outcome|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
22435|NCT02336958|E2|Reported Event|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.
pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
22456|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22726|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22474|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22436|NCT02336958|E1|Reported Event|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
22437|NCT02336763|B1|Baseline|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
External Beam Radiation Therapy: Undergo external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies"
22438|NCT02336763|P1|Participant Flow|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
External Beam Radiation Therapy: Undergo external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies"
22439|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
External Beam Radiation Therapy: Undergo external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies"
22440|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
External Beam Radiation Therapy: Undergo external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies"
22441|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
External Beam Radiation Therapy: Undergo external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies"
22442|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
External Beam Radiation Therapy: Undergo external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies"
22443|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
External Beam Radiation Therapy: Undergo external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies"
22444|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
External Beam Radiation Therapy: Undergo external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies"
22445|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
External Beam Radiation Therapy: Undergo external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies"
22446|NCT02336763|E1|Reported Event|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
External Beam Radiation Therapy: Undergo external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies"
22447|NCT02336607|B5|Baseline|Total|Total of all reporting groups
22448|NCT02336607|B4|Baseline|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22449|NCT02336607|B3|Baseline|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22450|NCT02336607|B2|Baseline|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22451|NCT02336607|B1|Baseline|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22452|NCT02336607|P4|Participant Flow|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22453|NCT02336607|P3|Participant Flow|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22454|NCT02336607|P2|Participant Flow|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22455|NCT02336607|P1|Participant Flow|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22457|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22458|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22459|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22460|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22461|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22462|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22463|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22464|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22465|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22466|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22467|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22468|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22469|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22470|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22471|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22472|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22473|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22567|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22568|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22475|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22476|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22477|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22478|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22479|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22480|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22481|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22482|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22483|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22484|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22485|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22486|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22487|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22488|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22489|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22490|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22569|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22570|NCT02336425|E4|Reported Event|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22491|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22493|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22494|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22495|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22496|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22497|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22498|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22499|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22500|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22501|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22502|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22503|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22504|NCT02336607|E4|Reported Event|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
22505|NCT02336607|E3|Reported Event|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
22506|NCT02336607|E2|Reported Event|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
22507|NCT02336607|E1|Reported Event|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
22571|NCT02336425|E3|Reported Event|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22572|NCT02336425|E2|Reported Event|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22508|NCT02336438|B1|Baseline|Baseline Phase (Control), Crossover to Treatment (Glucomannan)|"Control:
iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Glucomannan:
For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.
Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
22509|NCT02336438|P1|Participant Flow|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:
iPro® Continuous Glucose Monitor (CGM) device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.
Glucomannan:
iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
22510|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:
iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.
Glucomannan:
iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
22511|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:
iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.
Glucomannan:
iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
22512|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:
iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.
Glucomannan:
iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
22513|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:
iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.
Glucomannan:
iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
22514|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:
iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.
Glucomannan:
iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
22573|NCT02336425|E1|Reported Event|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22574|NCT02336178|B1|Baseline|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22575|NCT02336178|P1|Participant Flow|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22576|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22678|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA"
22515|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:
iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.
Glucomannan:
iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
22516|NCT02336438|E1|Reported Event|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:
iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Glucomannan:
For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.
Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
22517|NCT02336425|B5|Baseline|Total|Total of all reporting groups
22518|NCT02336425|B4|Baseline|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22519|NCT02336425|B3|Baseline|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22520|NCT02336425|B2|Baseline|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22521|NCT02336425|B1|Baseline|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22522|NCT02336425|P4|Participant Flow|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22523|NCT02336425|P3|Participant Flow|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22524|NCT02336425|P2|Participant Flow|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22525|NCT02336425|P1|Participant Flow|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22526|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22527|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22528|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22529|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22530|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22531|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22532|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22533|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22534|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22535|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22536|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22537|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22538|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22539|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22540|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22541|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22542|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22543|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22544|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22545|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22546|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22547|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22548|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22549|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22550|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22551|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22552|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22553|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22554|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22555|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22556|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22557|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22558|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22559|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22560|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22561|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22562|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
22563|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
22564|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
22565|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
22566|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
26299|NCT02298192|B3|Baseline|Total|Total of all reporting groups
22577|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22578|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22579|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22580|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22581|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22582|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22583|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22584|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22585|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22586|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22587|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22588|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22589|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22590|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22591|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22592|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22593|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22594|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22595|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22596|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22597|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22598|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22599|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22600|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22601|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22602|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22603|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22604|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22605|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22606|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22607|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22608|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22609|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22610|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22611|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22612|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22613|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22614|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received prophylaxis treatment with BeneFIX according to usual care in China and in accord with the China BeneFIX Package Insert. The treatment duration was 6 months (±7 days) or 50 Exposure Days (±5 EDs) whichever occurred first. On-demand treatment was given as needed.
22615|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22616|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22617|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22618|NCT02336178|O5|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22619|NCT02336178|O4|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22620|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22621|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22622|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22623|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22624|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22625|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22626|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22627|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22628|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22629|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22675|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
22630|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22631|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22632|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22633|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22634|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22635|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22636|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22637|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22638|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22639|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22640|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22641|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22642|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22643|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22644|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22645|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22646|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22647|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22648|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22649|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22650|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22651|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22652|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22653|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
22654|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22655|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
22656|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22657|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22658|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22659|NCT02336178|E1|Reported Event|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
22660|NCT02335710|B3|Baseline|Total|Total of all reporting groups
22661|NCT02335710|B2|Baseline|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
22662|NCT02335710|B1|Baseline|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates
Journey II BCS TKA"
22663|NCT02335710|P2|Participant Flow|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
22664|NCT02335710|P1|Participant Flow|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA"
22665|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
22666|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA"
22667|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
22668|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA"
22669|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
22670|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA"
22671|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
22672|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA"
22673|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
22674|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA"
22676|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA"
22677|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
22680|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA"
22681|NCT02335710|E2|Reported Event|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
22682|NCT02335710|E1|Reported Event|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA"
22683|NCT02335502|B1|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
22684|NCT02335502|P1|Participant Flow|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
22685|NCT02335502|O1|Outcome|Subjected Treated With the Permanent Implantable Axium System|All subjects treated with the Axium implantable neurostimulator
22686|NCT02335502|O1|Outcome|Subjected Treated With the Permanent Implantable Axium System|All subjects treated with the Axium implantable neurostimulator
22687|NCT02335502|E1|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
22688|NCT02335489|B1|Baseline|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
22689|NCT02335489|P1|Participant Flow|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
22690|NCT02335489|O1|Outcome|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
22691|NCT02335489|E1|Reported Event|All Enrolled Subjects|All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
22692|NCT02334982|B8|Baseline|Total|Total of all reporting groups
22693|NCT02334982|B7|Baseline|Cohorts 1-6: Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
22694|NCT02334982|B6|Baseline|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, once on Day 1.
22695|NCT02334982|B5|Baseline|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, once on Day 1.
22696|NCT02334982|B4|Baseline|Cohort 4: TAK-137 5 mg Food Effect|TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
22697|NCT02334982|B3|Baseline|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22698|NCT02334982|B2|Baseline|Cohort 2: TAK-137 5 mg|TAK-137 5 mg, tablets, orally, once on Day 1.
22699|NCT02334982|B1|Baseline|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, once on Day 1.
22700|NCT02334982|P7|Participant Flow|Cohorts 1-6: Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
22701|NCT02334982|P6|Participant Flow|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, once on Day 1.
22702|NCT02334982|P5|Participant Flow|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, once on Day 1.
22703|NCT02334982|P4|Participant Flow|Cohort 4: TAK-137 5 mg Food Effect|TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
22704|NCT02334982|P3|Participant Flow|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22705|NCT02334982|P2|Participant Flow|Cohort 2: TAK-137 5 mg|TAK-137 5 mg, tablets, orally, once on Day 1.
22706|NCT02334982|P1|Participant Flow|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, once on Day 1.
22707|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22708|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22709|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22710|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
22711|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22712|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22713|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22714|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22715|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22716|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22717|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
22718|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22719|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22720|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22721|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22722|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22723|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22724|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
22725|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
28968|NCT02269475|E3|Reported Event|Total Number|
22727|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22728|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22729|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22730|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22731|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
22733|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22734|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22735|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22736|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22737|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22738|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
22739|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22740|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22741|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22742|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22743|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22744|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22745|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
22746|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22747|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22748|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22749|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22750|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22751|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22752|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
22753|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22754|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22755|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22756|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22757|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22758|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22759|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
22760|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22761|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22762|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22763|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22764|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22765|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22766|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
22767|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22768|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22769|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22770|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22771|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22772|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22773|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
22774|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22775|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22776|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22777|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
22778|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22779|NCT02334982|O6|Outcome|TAK-137 Placebo|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
22780|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22781|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22782|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22783|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22785|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
22786|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22787|NCT02334982|O6|Outcome|Placebo Fasting|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
22788|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22789|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22790|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
41613|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
22791|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22792|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22793|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
22794|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22795|NCT02334982|O6|Outcome|TAK-137 Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
22796|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22797|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22798|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22799|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22800|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22801|NCT02334982|E8|Reported Event|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
22802|NCT02334982|E7|Reported Event|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
22803|NCT02334982|E6|Reported Event|Placebo Fasting|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
22804|NCT02334982|E5|Reported Event|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
22805|NCT02334982|E4|Reported Event|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
22806|NCT02334982|E3|Reported Event|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
22807|NCT02334982|E2|Reported Event|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
22808|NCT02334982|E1|Reported Event|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
22809|NCT02334813|B3|Baseline|Total|Total of all reporting groups
22810|NCT02334813|B2|Baseline|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).
Dexamethasone: 4-day pulses every 3 weeks"
22811|NCT02334813|B1|Baseline|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.
Prednisone: Continuous daily therapy"
22812|NCT02334813|P2|Participant Flow|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).
Dexamethasone: 4-day pulses every 3 weeks"
22813|NCT02334813|P1|Participant Flow|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.
Prednisone: Continuous daily therapy"
22814|NCT02334813|O2|Outcome|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).
Dexamethasone: 4-day pulses every 3 weeks"
22815|NCT02334813|O1|Outcome|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.
Prednisone: Continuous daily therapy"
22816|NCT02334813|E2|Reported Event|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).
Dexamethasone: 4-day pulses every 3 weeks"
22817|NCT02334813|E1|Reported Event|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.
Prednisone: Continuous daily therapy"
22818|NCT02334787|B5|Baseline|Total|Total of all reporting groups
22819|NCT02334787|B4|Baseline|Placebo|In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
22820|NCT02334787|B3|Baseline|3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
22821|NCT02334787|B2|Baseline|1% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
22822|NCT02334787|B1|Baseline|0.3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.
22823|NCT02334787|P4|Participant Flow|Placebo|In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
22824|NCT02334787|P3|Participant Flow|3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
22825|NCT02334787|P2|Participant Flow|1% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
23435|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
22826|NCT02334787|P1|Participant Flow|0.3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.
22827|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
22828|NCT02334787|O2|Outcome|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
22829|NCT02334787|O1|Outcome|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
22830|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3% OPA-15406 ointment assessed until 48 hours postdose.
22831|NCT02334787|O2|Outcome|1% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1% OPA-15406 ointment assessed until 48 hours postdose.
22832|NCT02334787|O1|Outcome|0.3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned0.3％OPA-15406 ointment assessed until 48 hours postdose.
22833|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
22834|NCT02334787|O2|Outcome|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
22835|NCT02334787|O1|Outcome|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
22836|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3% OPA-15406 ointment assessed until 48 hours postdose.
22837|NCT02334787|O2|Outcome|1% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1% OPA-15406 ointment assessed until 48 hours postdose.
22838|NCT02334787|O1|Outcome|0.3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned0.3％OPA-15406 ointment assessed until 48 hours postdose.
22839|NCT02334787|E8|Reported Event|Placebo Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.
22840|NCT02334787|E7|Reported Event|3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
22841|NCT02334787|E6|Reported Event|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
22842|NCT02334787|E5|Reported Event|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
22843|NCT02334787|E4|Reported Event|Placebo in a Single Adminstaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned placebo ointment.
22844|NCT02334787|E3|Reported Event|3% OPA-15406 Ointment in a Single Administaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
22845|NCT02334787|E2|Reported Event|1% OPA-15406 Ointment in a Single Administaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single and administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
22846|NCT02334787|E1|Reported Event|0.3 % OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment
22847|NCT02334267|B3|Baseline|Total|Total of all reporting groups
22848|NCT02334267|B2|Baseline|Group 2 Week 1 NaturaLyte and Week 2 GranuFlo|"Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
NaturaLyte: Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
22870|NCT02332798|B1|Baseline|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22871|NCT02332798|P3|Participant Flow|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22872|NCT02332798|P2|Participant Flow|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22849|NCT02334267|B1|Baseline|Group 1Week 1 GranuFlo and Week 2 NaturaLyte|"Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
GranuFlow: Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
22850|NCT02334267|P2|Participant Flow|Group 2 Week 1 NaturaLyte and Week 2 GranuFlo|"Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
NaturaLyte: Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
22851|NCT02334267|P1|Participant Flow|Group 1 Week 1 GranuFlo and Week 2 NaturaLyte|"Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
GranuFlow: Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
22852|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic venous blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
22853|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic venous blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
22854|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic arterialized blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
22855|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic arterialized blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
22856|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic venous blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
22857|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic venous blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
22858|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
22859|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
22860|NCT02334267|E2|Reported Event|NaturaLyte|The safety reporting group included subjects who received one study related hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte.
22861|NCT02334267|E1|Reported Event|GranuFlo|The safety reporting group included subjects who received one study related hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo.
22862|NCT02332902|B1|Baseline|Intervention|"This is a single arm intervention using Everolimus.
Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
22863|NCT02332902|P1|Participant Flow|Intervention|"This is a single arm intervention using Everolimus.
Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
22864|NCT02332902|O1|Outcome|Intervention|"This is a single arm intervention using Everolimus.
Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
22865|NCT02332902|O1|Outcome|Intervention|"This is a single arm intervention using Everolimus.
Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
22866|NCT02332902|E1|Reported Event|Intervention|"This is a single arm intervention using Everolimus.
Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
22867|NCT02332798|B4|Baseline|Total|Total of all reporting groups
22868|NCT02332798|B3|Baseline|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22869|NCT02332798|B2|Baseline|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22873|NCT02332798|P1|Participant Flow|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 milligram (mg) twice daily (BID) for 14 consecutive days with the last dose occurring in the morning on Day 14.
22874|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22875|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22876|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22877|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22878|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22879|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22880|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22881|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22882|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22883|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22884|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22885|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22886|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22887|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22888|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22889|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22890|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22891|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22892|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22893|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22894|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22895|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22896|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22897|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22898|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22899|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22900|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22901|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22902|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22903|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22904|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22905|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22906|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22907|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
28969|NCT02269475|E2|Reported Event|Placebo|Placebo, 0.2mL as nasal spray
22908|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22909|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22910|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22911|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22912|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22913|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22914|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22915|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22916|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22917|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22918|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22919|NCT02332798|E3|Reported Event|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22920|NCT02332798|E2|Reported Event|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22921|NCT02332798|E1|Reported Event|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
22922|NCT02332590|B3|Baseline|Total|Total of all reporting groups
22923|NCT02332590|B2|Baseline|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants completed 24 weeks treatment period had the option to continue in open-label treatment period and received sarilumab 200 mg q2w until commercial availability of sarilumab in the country or maximum of 276 weeks.
22924|NCT02332590|B1|Baseline|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants completed 24 weeks treatment period had the option to continue in open-label treatment period and received sarilumab 200 mg q2w until commercial availability of sarilumab in the country or maximum of 276 weeks.
22925|NCT02332590|P2|Participant Flow|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants completed 24 weeks treatment period had the option to continue in open-label treatment period and received sarilumab 200 mg q2w until commercial availability of sarilumab in the country or maximum of 276 weeks.
22926|NCT02332590|P1|Participant Flow|Adalimumab 40 mg|Adalimumab 40 mg subcutaneous (SC) injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (<20% improvement from baseline tender joint count [TJC] and swollen joint count [SJC] for 2 consecutive visits) at or after Week 16 until Week 23. Participants completed 24 weeks treatment period had the option to continue in open-label treatment period and received sarilumab 200 mg q2w until commercial availability of sarilumab in the country or maximum of 276 weeks.
22927|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22928|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22929|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22930|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22931|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
23396|NCT02329015|B2|Baseline|Physical Education Class|"Behavioral intervention
Physical Education Class: Standard physical education"
22932|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22987|NCT02331940|B3|Baseline|Total|Total of all reporting groups
23782|NCT02322788|B1|Baseline|Overall|Total number of participants in the Full analysis set
22933|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22934|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22935|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22936|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22937|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22938|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22939|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22940|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22941|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22942|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22943|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22944|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22945|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22946|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22947|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22948|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22949|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
23013|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks
Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
24206|NCT02318693|P1|Participant Flow|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
22950|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22951|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22952|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22953|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22954|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22955|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22956|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22957|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22958|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22959|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22960|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22961|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22962|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22963|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22964|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22965|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22966|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22967|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
23014|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks
KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
23016|NCT02331589|E1|Reported Event|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks
KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
22968|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22969|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22970|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22971|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22972|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22973|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22974|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22975|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22976|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22977|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22978|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22979|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22980|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22981|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22982|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22983|NCT02332590|O2|Outcome|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22984|NCT02332590|O1|Outcome|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22985|NCT02332590|E2|Reported Event|Sarilumab 200 mg|Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during randomized treatment period. The dosing frequency of placebo for adalimumab may be adjusted to qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
23015|NCT02331589|E2|Reported Event|Placebo (for KRG)|"placebo (for KRG) for 3 weeks
Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
23017|NCT02331446|B5|Baseline|Total|Total of all reporting groups
22986|NCT02332590|E1|Reported Event|Adalimumab 40 mg|Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during randomized treatment period. The dosing frequency of adalimumab may be adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.
22988|NCT02331940|B2|Baseline|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Respimat: Inhalation via the Respimat once daily"
22989|NCT02331940|B1|Baseline|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Handihaler: Inhalation via the HandiHaler once daily"
22990|NCT02331940|P2|Participant Flow|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Respimat: Inhalation via the Respimat once daily"
22991|NCT02331940|P1|Participant Flow|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Handihaler: Inhalation via the HandiHaler once daily"
22992|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Respimat: Inhalation via the Respimat once daily"
22993|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Handihaler: Inhalation via the HandiHaler once daily"
22994|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Respimat: Inhalation via the Respimat once daily"
22995|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Handihaler: Inhalation via the HandiHaler once daily"
22996|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Respimat: Inhalation via the Respimat once daily"
22997|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Handihaler: Inhalation via the HandiHaler once daily"
22998|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Respimat: Inhalation via the Respimat once daily"
22999|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Handihaler: Inhalation via the HandiHaler once daily"
23000|NCT02331940|E2|Reported Event|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Respimat: Inhalation via the Respimat once daily"
23001|NCT02331940|E1|Reported Event|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Handihaler: Inhalation via the HandiHaler once daily"
23002|NCT02331589|B3|Baseline|Total|Total of all reporting groups
23003|NCT02331589|B2|Baseline|Placebo (for KRG)|"placebo (for KRG) for 3 weeks
Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
23004|NCT02331589|B1|Baseline|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks
KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
23005|NCT02331589|P2|Participant Flow|Placebo (for KRG)|"placebo (for KRG) for 3 weeks
Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
23006|NCT02331589|P1|Participant Flow|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks
KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
23007|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks
Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
23008|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks
KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
23009|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks
Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
23010|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks
KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
23011|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks
Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
23012|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks
KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
23018|NCT02331446|B4|Baseline|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23049|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23019|NCT02331446|B3|Baseline|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23020|NCT02331446|B2|Baseline|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23021|NCT02331446|B1|Baseline|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23022|NCT02331446|P4|Participant Flow|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23023|NCT02331446|P3|Participant Flow|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23024|NCT02331446|P2|Participant Flow|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23025|NCT02331446|P1|Participant Flow|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23026|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23027|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23028|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23029|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23030|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23031|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23032|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23033|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23034|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23035|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23036|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23037|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23038|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23039|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23040|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23041|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23042|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23043|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23044|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23045|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23046|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23047|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23398|NCT02329015|P2|Participant Flow|Physical Education Class|"Behavioral intervention
Physical Education Class: Standard physical education"
29488|NCT02261948|B3|Baseline|Total|Total of all reporting groups
23048|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23050|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23051|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23052|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23053|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23054|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23055|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23056|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23057|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23058|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23059|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23060|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23061|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23062|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23063|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23064|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23065|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23066|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23067|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23068|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23069|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23070|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23071|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23072|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23073|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23074|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23075|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23076|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23077|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23078|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
29896|NCT02256891|O1|Outcome|Double Row|"Double Row
Double Row"
23079|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23783|NCT02322788|P4|Participant Flow|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
41614|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
23080|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23081|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23082|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23083|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23084|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23085|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23086|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23087|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23088|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23089|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23090|NCT02331446|E4|Reported Event|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
Physical exercise intervention"
23091|NCT02331446|E3|Reported Event|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention"
23092|NCT02331446|E2|Reported Event|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.
Physical exercise intervention"
23093|NCT02331446|E1|Reported Event|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
23094|NCT02331108|B7|Baseline|Total|Total of all reporting groups
23095|NCT02331108|B6|Baseline|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23096|NCT02331108|B5|Baseline|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23097|NCT02331108|B4|Baseline|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23098|NCT02331108|B3|Baseline|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23099|NCT02331108|B2|Baseline|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23100|NCT02331108|B1|Baseline|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23101|NCT02331108|P6|Participant Flow|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23102|NCT02331108|P5|Participant Flow|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23103|NCT02331108|P4|Participant Flow|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
24207|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
23434|NCT02328404|P1|Participant Flow|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23104|NCT02331108|P3|Participant Flow|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23105|NCT02331108|P2|Participant Flow|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23106|NCT02331108|P1|Participant Flow|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23107|NCT02331108|O2|Outcome|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23108|NCT02331108|O1|Outcome|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23109|NCT02331108|O6|Outcome|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23110|NCT02331108|O5|Outcome|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23111|NCT02331108|O4|Outcome|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23112|NCT02331108|O3|Outcome|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23113|NCT02331108|O2|Outcome|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23114|NCT02331108|O1|Outcome|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23115|NCT02331108|O6|Outcome|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23116|NCT02331108|O5|Outcome|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23117|NCT02331108|O4|Outcome|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23118|NCT02331108|O3|Outcome|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23119|NCT02331108|O2|Outcome|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23120|NCT02331108|O1|Outcome|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23121|NCT02331108|E6|Reported Event|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23432|NCT02328404|B1|Baseline|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
25865|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
23122|NCT02331108|E5|Reported Event|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23123|NCT02331108|E4|Reported Event|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23124|NCT02331108|E3|Reported Event|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23125|NCT02331108|E2|Reported Event|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23126|NCT02331108|E1|Reported Event|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.
Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
23127|NCT02330588|B6|Baseline|Total|Total of all reporting groups
23128|NCT02330588|B5|Baseline|eHealth Control Arm (Heads Up)|
23129|NCT02330588|B4|Baseline|Intervention Arm (Move It, Normative Feedback)|
23130|NCT02330588|B3|Baseline|Intervention Arm (Move It, Injunctive Feedback)|
23131|NCT02330588|B2|Baseline|Intervention Arm (Eat It, Normative Feedback)|
23132|NCT02330588|B1|Baseline|Intervention Arm (Eat It, Injunctive Feedback)|
23133|NCT02330588|P5|Participant Flow|eHealth Control|Parents randomly assigned to the control arm will include information on children's lifestyle behaviors only (no intervention questions).
23134|NCT02330588|P4|Participant Flow|Move It (Normative Feedback)|Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with normative feedback (i.e., referent data from Canadian children).
23135|NCT02330588|P3|Participant Flow|Move It (Injunctive Feedback)|Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with injunctive feedback (i.e., Canadian guidelines).
23136|NCT02330588|P2|Participant Flow|Eat It (Normative Feedback)|Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with normative feedback (i.e., referent data from Canadian children).
23137|NCT02330588|P1|Participant Flow|Eat It (Injunctive Feedback)|Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with injunctive feedback (i.e., Canadian guidelines).
23138|NCT02330588|O6|Outcome|All Groups (Total)|
23139|NCT02330588|O5|Outcome|Heads Up (eHealth Control)|
23140|NCT02330588|O4|Outcome|Move It (Normative Feedback)|
23141|NCT02330588|O3|Outcome|Move It (Injunctive Feedback)|
23142|NCT02330588|O2|Outcome|Eat It (Normative Feedback)|
23143|NCT02330588|O1|Outcome|Eat It (Injunctive Feedback)|
23144|NCT02330588|O6|Outcome|eHealth Control|
23145|NCT02330588|O5|Outcome|Move It (Normative Feedback)|
23146|NCT02330588|O4|Outcome|Move It (Injunctive Feedback)|
23147|NCT02330588|O3|Outcome|Eat It (Normative Feedback)|
23148|NCT02330588|O2|Outcome|Eat It (Injunctive Feedback)|
23149|NCT02330588|O1|Outcome|Feasibility (Uptake)|All groups (brief intervention + eHealth control)
23150|NCT02330588|O6|Outcome|eHealth Control|
23151|NCT02330588|O5|Outcome|Move It (Normative Feedback)|
23152|NCT02330588|O4|Outcome|Move It (Injunctive Feedback)|
23153|NCT02330588|O3|Outcome|Eat It (Normative Feedback)|
23154|NCT02330588|O2|Outcome|Eat It (Injunctive Feedback)|
23155|NCT02330588|O1|Outcome|All Groups (Total)|All groups (four brief interventions + eHealth control)
23156|NCT02330588|E5|Reported Event|eHealth Control|
23157|NCT02330588|E4|Reported Event|Move It (Normative)|
23158|NCT02330588|E3|Reported Event|Move It (Injunctive)|
23159|NCT02330588|E2|Reported Event|Eat It (Normative)|
23160|NCT02330588|E1|Reported Event|Eat It (Injunctive)|
23161|NCT02330523|B3|Baseline|Total|Total of all reporting groups
23162|NCT02330523|B2|Baseline|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23163|NCT02330523|B1|Baseline|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23433|NCT02328404|P2|Participant Flow|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23164|NCT02330523|P2|Participant Flow|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23165|NCT02330523|P1|Participant Flow|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23166|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23167|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23168|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23169|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23170|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23171|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23172|NCT02330523|E2|Reported Event|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23173|NCT02330523|E1|Reported Event|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
23174|NCT02330276|B4|Baseline|Total|Total of all reporting groups
23489|NCT02327117|B1|Baseline|Tranexamic Acid|Tranexamic Acid
23175|NCT02330276|B3|Baseline|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23176|NCT02330276|B2|Baseline|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23177|NCT02330276|B1|Baseline|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23178|NCT02330276|P3|Participant Flow|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23179|NCT02330276|P2|Participant Flow|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23180|NCT02330276|P1|Participant Flow|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23181|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23182|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23183|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23184|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23185|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23186|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23187|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23188|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23397|NCT02329015|B1|Baseline|Health and Wellness Program|"Behavioral intervention
Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
23189|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23190|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23191|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23192|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23193|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23194|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23195|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23196|NCT02330276|E3|Reported Event|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23197|NCT02330276|E2|Reported Event|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23198|NCT02330276|E1|Reported Event|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
23199|NCT02330172|B3|Baseline|Total|Total of all reporting groups
23200|NCT02330172|B2|Baseline|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.
When the end of operation,, a injection of neostigmine or sugammadex be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
23201|NCT02330172|B1|Baseline|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.
When the end of operation, a injection of neostigmine or sugammadex will be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
23202|NCT02330172|P2|Participant Flow|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.
When the end of operation,, a injection of neostigmine or sugammadex be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
23232|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23203|NCT02330172|P1|Participant Flow|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.
When the end of operation, a injection of neostigmine or sugammadex will be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
23204|NCT02330172|O2|Outcome|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.
When the end of operation,, a injection of neostigmine or sugammadex be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
23205|NCT02330172|O1|Outcome|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.
When the end of operation, a injection of neostigmine or sugammadex will be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
23206|NCT02330172|O2|Outcome|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.
When the end of operation,, a injection of neostigmine or sugammadex be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
23207|NCT02330172|O1|Outcome|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.
When the end of operation, a injection of neostigmine or sugammadex will be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
23208|NCT02330172|E2|Reported Event|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.
When the end of operation,, a injection of neostigmine or sugammadex be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
23209|NCT02330172|E1|Reported Event|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.
When the end of operation, a injection of neostigmine or sugammadex will be administered.
Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
23210|NCT02329964|B3|Baseline|Total|Total of all reporting groups
23211|NCT02329964|B2|Baseline|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23212|NCT02329964|B1|Baseline|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23213|NCT02329964|P2|Participant Flow|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23214|NCT02329964|P1|Participant Flow|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23215|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23216|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23490|NCT02327117|P2|Participant Flow|Normal Saline|Normal saline
23217|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23218|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23219|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23220|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23221|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23222|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23223|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23224|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23225|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23226|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23227|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23228|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23229|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23230|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23231|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23233|NCT02329964|E2|Reported Event|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Succinylcholine 1mg/kg
After endotracheal intubation,
Cisatracurium 0.08mg/kg
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Succinylcholine 10mg
Relaxant agent reversal. at the appearance of second TOF twitch (T2).
Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
23234|NCT02329964|E1|Reported Event|R-S Group|"Rocuronium-Sugammadex group
Induction agent :
IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg
During induction of anesthesia, as muscle relaxant agent
Rocuronium 1mg/kg
After endotracheal intubation
normal saline(0.025 ml/kg)
Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery
Rocuronium 0.15mg/kg
Relaxant agent reversal. at the the end of surgery.
sugammadex 2mg/kg"
23235|NCT02329730|B5|Baseline|Total|Total of all reporting groups
23236|NCT02329730|B4|Baseline|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23237|NCT02329730|B3|Baseline|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23238|NCT02329730|B2|Baseline|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23239|NCT02329730|B1|Baseline|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23240|NCT02329730|P12|Participant Flow|Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.
Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
23241|NCT02329730|P11|Participant Flow|Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.
Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
23242|NCT02329730|P10|Participant Flow|Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.
Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
23243|NCT02329730|P9|Participant Flow|Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.
Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
23244|NCT02329730|P8|Participant Flow|Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
23245|NCT02329730|P7|Participant Flow|Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
23246|NCT02329730|P6|Participant Flow|Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
23378|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
23491|NCT02327117|P1|Participant Flow|Tranexamic Acid|Tranexamic Acid
23247|NCT02329730|P5|Participant Flow|Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
23248|NCT02329730|P4|Participant Flow|Healthy Subjects-20μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
23249|NCT02329730|P3|Participant Flow|Healthy Subjects-10μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
23250|NCT02329730|P2|Participant Flow|Healthy Subjects-5μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
23251|NCT02329730|P1|Participant Flow|Healthy Subjects-1μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
23252|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23253|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23254|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23255|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23256|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23257|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23258|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23259|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23379|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
23260|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23261|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23262|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23263|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23264|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23265|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23266|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23267|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23268|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23269|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23270|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23271|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23380|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
23381|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
23382|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
23272|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23273|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23274|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23275|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23276|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23277|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23278|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23279|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23280|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23281|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23282|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23283|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23383|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
23384|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
23385|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
23284|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23285|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23286|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23287|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23288|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23289|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23290|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23291|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23292|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23293|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23294|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23295|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23386|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
23387|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
23388|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
23296|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23297|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23298|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23299|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23300|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23301|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23302|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23303|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23304|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23305|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23306|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23307|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23389|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
23390|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
23391|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
23308|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23309|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23310|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23311|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
23312|NCT02329730|E12|Reported Event|Tuberculosis Subjects- 20μg/ml EC and Placebo|The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23313|NCT02329730|E11|Reported Event|Tuberculosis Subjects- 10μg/ml EC and Placebo|The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23314|NCT02329730|E10|Reported Event|Tuberculosis Subjects- 5μg/ml EC and Placebo|The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23315|NCT02329730|E9|Reported Event|Tuberculosis Subjects- 1μg/ml EC and Placebo|The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23316|NCT02329730|E8|Reported Event|Tuberculosis Subjects- 20μg/ml EC and TB-PPD|The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23317|NCT02329730|E7|Reported Event|Tuberculosis Subjects- 10μg/ml EC and TB-PPD|The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23318|NCT02329730|E6|Reported Event|Tuberculosis Subjects- 5μg/ml EC and TB-PPD|The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23319|NCT02329730|E5|Reported Event|Tuberculosis Subjects- 1μg/mlEC and TB-PPD|The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23320|NCT02329730|E4|Reported Event|Healthy Subjects-20μg/ml EC and TB-PPD|The healthy subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23321|NCT02329730|E3|Reported Event|Healthy Subjects-10μg/ml EC and TB-PPD|The healthy subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23322|NCT02329730|E2|Reported Event|Healthy Subjects-5μg/ml EC and TB-PPD|The healthy subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23323|NCT02329730|E1|Reported Event|Healthy Subjects-1μg/ml ECand TB-PPD|The healthy subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
23324|NCT02329600|B4|Baseline|Total|Total of all reporting groups
23325|NCT02329600|B3|Baseline|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
23326|NCT02329600|B2|Baseline|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
23327|NCT02329600|B1|Baseline|Control Subjects|10 systemically healthy control subjects taking no medication.
23328|NCT02329600|P3|Participant Flow|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
23329|NCT02329600|P2|Participant Flow|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
23330|NCT02329600|P1|Participant Flow|Control Subjects|10 systemically healthy control subjects taking no medication.
23331|NCT02329600|O3|Outcome|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
23332|NCT02329600|O2|Outcome|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
23333|NCT02329600|O1|Outcome|Control Subjects|10 systemically healthy control subjects taking no medication.
23334|NCT02329600|O3|Outcome|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
23335|NCT02329600|O2|Outcome|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
23336|NCT02329600|O1|Outcome|Control Subjects|10 systemically healthy control subjects taking no medication.
23392|NCT02329223|E3|Reported Event|Placebo|Placebo
23337|NCT02329600|E3|Reported Event|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
23338|NCT02329600|E2|Reported Event|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
23339|NCT02329600|E1|Reported Event|Control Subjects|10 systemically healthy control subjects taking no medication.
23340|NCT02329431|B3|Baseline|Total|Total of all reporting groups
23341|NCT02329431|B2|Baseline|Support Group|"Parent-directed support group
support group: parent directed support group"
23342|NCT02329431|B1|Baseline|Activation Curriculum|"Psycho-social curriculum teaching activation skills
activation curriculum: psychosocial activation curriculum"
23343|NCT02329431|P2|Participant Flow|Support Group|"Parent-directed support group
support group: parent directed support group"
23344|NCT02329431|P1|Participant Flow|Activation Curriculum|"Psycho-social curriculum teaching activation skills
activation curriculum: psychosocial activation curriculum"
23345|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group
support group: parent directed support group"
23346|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills
activation curriculum: psychosocial activation curriculum"
23347|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group
support group: parent directed support group"
23348|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills
activation curriculum: psychosocial activation curriculum"
23349|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group
support group: parent directed support group"
23350|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills
activation curriculum: psychosocial activation curriculum"
23351|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group
support group: parent directed support group"
23352|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills
activation curriculum: psychosocial activation curriculum"
23353|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group
support group: parent directed support group"
23354|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills
activation curriculum: psychosocial activation curriculum"
23355|NCT02329431|O2|Outcome|Support Group|"Parent-directed support group
support group: parent directed support group"
23356|NCT02329431|O1|Outcome|Activation Curriculum|"Psycho-social curriculum teaching activation skills
activation curriculum: psychosocial activation curriculum"
23357|NCT02329431|E2|Reported Event|Support Group|"Parent-directed support group
support group: parent directed support group"
23358|NCT02329431|E1|Reported Event|Activation Curriculum|"Psycho-social curriculum teaching activation skills
activation curriculum: psychosocial activation curriculum"
23359|NCT02329223|B4|Baseline|Total|Total of all reporting groups
23360|NCT02329223|B3|Baseline|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
23361|NCT02329223|B2|Baseline|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
23362|NCT02329223|B1|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
23363|NCT02329223|P3|Participant Flow|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
23364|NCT02329223|P2|Participant Flow|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
23365|NCT02329223|P1|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
23366|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
23367|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
23368|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
23369|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
23370|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
23371|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
23372|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
23373|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
23374|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
23375|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
23376|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
23377|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
23399|NCT02329015|P1|Participant Flow|Health and Wellness Program|"Behavioral intervention
Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
23400|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention
Physical Education Class: Standard physical education"
23401|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention
Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
23402|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention
Physical Education Class: Standard physical education"
23403|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention
Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
23404|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention
Physical Education Class: Standard physical education"
23405|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention
Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
23406|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention
Physical Education Class: Standard physical education"
23407|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention
Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
23408|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention
Physical Education Class: Standard physical education"
23409|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention
Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
23410|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention
Physical Education Class: Standard physical education"
23411|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention
Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
23412|NCT02329015|E2|Reported Event|Physical Education Class|"Behavioral intervention
Physical Education Class: Standard physical education"
23413|NCT02329015|E1|Reported Event|Health and Wellness Program|"Behavioral intervention
Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
23414|NCT02328937|B1|Baseline|Overall|All subjects that were dispensed at least one study lens.
23415|NCT02328937|P6|Participant Flow|Comfilcon A/Lotrafilcon B/Etafilcon A|Subjects randomized to this sequence received comfilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received etafilcon A during the last period.
23416|NCT02328937|P5|Participant Flow|Comfilcon A/Etafilcon A/Lotrafilcon B|Subjects randomized to this sequence received comfilcon A during the 1st period, then received etafilcon A during the 2nd period, and then received lotrafilcon B during the last period.
23417|NCT02328937|P4|Participant Flow|Lotrafilcon B/Comfilcon A/Etafilcon A|Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received comfilcon A during the 2nd period, and then received etafilcon A during the last period.
23418|NCT02328937|P3|Participant Flow|Lotrafilcon B/Etafilcon A/Comfilcon A|Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received etafilcon A during the 2nd period, and then received comfilcon A during the last period.
23419|NCT02328937|P2|Participant Flow|Etafilcon A/Comfilcon A/Lotrafilcon B|Subjects randomized to this sequence received etafilcon A during the 1st period, then received comfilcon A during the 2nd period, and then received lotrafilcon B during the last period.
23420|NCT02328937|P1|Participant Flow|Etafilcon A/Lotrafilcon B/Comfilcon A|Subjects randomized to this sequence received etafilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received comfilcon A during the last period.
23421|NCT02328937|O3|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
23422|NCT02328937|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
23423|NCT02328937|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
23424|NCT02328937|O3|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
23425|NCT02328937|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
23426|NCT02328937|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
23427|NCT02328937|E3|Reported Event|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
23428|NCT02328937|E2|Reported Event|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
23429|NCT02328937|E1|Reported Event|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
23430|NCT02328404|B3|Baseline|Total|Total of all reporting groups
23431|NCT02328404|B2|Baseline|Placebo (Biodal 50,000IU Placebo)|"Placebo (Biodal 50,000IU Placebo tablets) coated tablets by oral route
Placebo: 50,000IU Vitamin D3 placebo (Biodal 50,000IU placebo) once weekly for 3 months"
23492|NCT02327117|O2|Outcome|Normal Saline|Normal saline
23436|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23437|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23438|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50.000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23439|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23440|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23441|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23442|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23443|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23444|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23445|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo (Biodal 50,000 IU): 50.000IU Vitamin D3 (Biodal 50.000IU ) placebo once weekly for 3 months"
23446|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23447|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23448|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23449|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23450|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23451|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23452|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50.000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23453|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23454|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50.000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23455|NCT02328404|O2|Outcome|Placebo|"Placebo coated tablet by oral route
Placebo: placebo coated tablet by oral route"
23456|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23457|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23458|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23459|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23460|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23461|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23462|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23463|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23464|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23465|NCT02328404|E2|Reported Event|Placebo|"placebo coated tablet by oral route
placebo: placebo coated tablet by oral route"
23466|NCT02328404|E1|Reported Event|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route
50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
23467|NCT02327429|B1|Baseline|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23468|NCT02327429|P1|Participant Flow|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23469|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23493|NCT02327117|O1|Outcome|Tranexamic Acid|Tranexamic Acid
23470|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23471|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23472|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23473|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23474|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23475|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23476|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23477|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23478|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23479|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23480|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23481|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23482|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23483|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23484|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23485|NCT02327429|O1|Outcome|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23486|NCT02327429|E1|Reported Event|A Chinese Menu Plan for Type 2 Diabetes|"All participants will be in the intervention arm for this pilot study
A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet."
23487|NCT02327117|B3|Baseline|Total|Total of all reporting groups
23488|NCT02327117|B2|Baseline|Normal Saline|Normal saline
23496|NCT02326844|B1|Baseline|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
27297|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
23497|NCT02326844|P1|Participant Flow|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
23498|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
23499|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
23500|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
23501|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
23502|NCT02326844|E1|Reported Event|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
23503|NCT02326649|B1|Baseline|Diagnosis, Age, and Body Size of Subjects|Overall
23504|NCT02326649|P1|Participant Flow|SMIC and CMR|Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
23505|NCT02326649|O1|Outcome|SMIC and CMR|Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
23506|NCT02326649|E1|Reported Event|CHD Patients Undergoing Cardiac MRI Without Sedation|Physioflow: impedance cardiography instrument that measures cardiac output non-invasively
23507|NCT02325856|B3|Baseline|Total|Total of all reporting groups
23508|NCT02325856|B2|Baseline|Control Group|Dry weight determined by clinical symptoms
23509|NCT02325856|B1|Baseline|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)
Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
23510|NCT02325856|P2|Participant Flow|Control Group|Dry weight determined by clinical symptoms
23511|NCT02325856|P1|Participant Flow|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)
Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
23512|NCT02325856|O2|Outcome|Control Group|Dry weight determined by clinical symptoms
23513|NCT02325856|O1|Outcome|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)
Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
23514|NCT02325856|O2|Outcome|Control Group|Dry weight determined by clinical symptoms
23515|NCT02325856|O1|Outcome|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)
Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
23516|NCT02325856|E2|Reported Event|Control Group|Dry weight determined by clinical symptoms
23517|NCT02325856|E1|Reported Event|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)
Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
23518|NCT02325713|B17|Baseline|Total|Total of all reporting groups
23519|NCT02325713|B16|Baseline|Sequence B-A-D2-C2|Subjects randomized to treatment sequence B-A-D2-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23520|NCT02325713|B15|Baseline|Sequence B-A-D1-C2|Subjects randomized to treatment sequence B-A-D1-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23521|NCT02325713|B14|Baseline|Sequence B-A-D2-C1|Subjects randomized to treatment sequence B-A-D2-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23968|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23555|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23522|NCT02325713|B13|Baseline|Sequence B-A-D1-C1|Subjects randomized to treatment sequence B-A-D1-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23523|NCT02325713|B12|Baseline|Sequence B-A-C2-D2|Subjects randomized to treatment sequence B-A-C2-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23524|NCT02325713|B11|Baseline|Sequence B-A-C2-D1|Subjects randomized to treatment sequence B-A-C2-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23525|NCT02325713|B10|Baseline|Sequence B-A-C1-D2|Subjects randomized to treatment sequence B-A-C1-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23526|NCT02325713|B9|Baseline|Sequence B-A-C1-D1|Subjects randomized to treatment sequence B-A-C1-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23527|NCT02325713|B8|Baseline|Sequence A-B-D2-C2|Subjects randomized to treatment sequence A-B-D2-C2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23528|NCT02325713|B7|Baseline|Sequence A-B-D1-C2|Subjects randomized to treatment sequence A-B-D1-C2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23529|NCT02325713|B6|Baseline|Sequence A-B-D2-C1|Subjects randomized to treatment sequence A-B-D2-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23530|NCT02325713|B5|Baseline|Sequence A-B-D1-C1|Subjects randomized to treatment sequence A-B-D1-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23531|NCT02325713|B4|Baseline|Sequence A-B-C2-D2|Subjects randomized to treatment sequence A-B-C2-D2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23554|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23532|NCT02325713|B3|Baseline|Sequence A-B-C2-D1|Subjects randomized to treatment sequence A-B-C2-D1 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23533|NCT02325713|B2|Baseline|Sequence A-B-C1-D2|Subjects randomized to treatment sequence A-B-C1-D2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23534|NCT02325713|B1|Baseline|Sequence A-B-C1-D1|Subjects randomized to treatment sequence A-B-C1-D1 received a single oral dose of 40 milligram per kilogram (40 mg/kg) of test oral dispersible tablet of praziquantel (ODT-PZQ) dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23535|NCT02325713|P16|Participant Flow|Sequence B-A-D2-C2|Subjects randomized to treatment sequence B-A-D2-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23536|NCT02325713|P15|Participant Flow|Sequence B-A-D1-C2|Subjects randomized to treatment sequence B-A-D1-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23537|NCT02325713|P14|Participant Flow|Sequence B-A-D2-C1|Subjects randomized to treatment sequence B-A-D2-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23538|NCT02325713|P13|Participant Flow|Sequence B-A-D1-C1|Subjects randomized to treatment sequence B-A-D1-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23539|NCT02325713|P12|Participant Flow|Sequence B-A-C2-D2|Subjects randomized to treatment sequence B-A-C2-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23540|NCT02325713|P11|Participant Flow|Sequence B-A-C2-D1|Subjects randomized to treatment sequence B-A-C2-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23541|NCT02325713|P10|Participant Flow|Sequence B-A-C1-D2|Subjects randomized to treatment sequence B-A-C1-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
24013|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
23542|NCT02325713|P9|Participant Flow|Sequence B-A-C1-D1|Subjects randomized to treatment sequence B-A-C1-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23543|NCT02325713|P8|Participant Flow|Sequence A-B-D2-C2|Subjects randomized to treatment sequence A-B-D2-C2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23544|NCT02325713|P7|Participant Flow|Sequence A-B-D1-C2|Subjects randomized to treatment sequence A-B-D1-C2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23545|NCT02325713|P6|Participant Flow|Sequence A-B-D2-C1|Subjects randomized to treatment sequence A-B-D2-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23546|NCT02325713|P5|Participant Flow|Sequence A-B-D1-C1|Subjects randomized to treatment sequence A-B-D1-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23547|NCT02325713|P4|Participant Flow|Sequence A-B-C2-D2|Subjects randomized to treatment sequence A-B-C2-D2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23548|NCT02325713|P3|Participant Flow|Sequence A-B-C2-D1|Subjects randomized to treatment sequence A-B-C2-D1 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23549|NCT02325713|P2|Participant Flow|Sequence A-B-C1-D2|Subjects randomized to treatment sequence A-B-C1-D2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23550|NCT02325713|P1|Participant Flow|Sequence A-B-C1-D1|Subjects randomized to treatment sequence A-B-C1-D1 received a single oral dose of 40 milligram per kilogram (40 mg/kg) of test oral dispersible tablet of praziquantel (ODT-PZQ) dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
23551|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23552|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23553|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
24014|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
23556|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23557|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23558|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23559|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23560|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23561|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23562|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23563|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23564|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23565|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23566|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23567|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23568|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23569|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23570|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23571|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23572|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23573|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23574|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23575|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23576|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23577|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23578|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23579|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23580|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23581|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23582|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23583|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23584|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
29981|NCT02256072|B3|Baseline|Total|Total of all reporting groups
23585|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23586|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23587|NCT02325713|O1|Outcome|PZQ 40 mg/kg (Treatment A and Treatment B)|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal and reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23588|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23589|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23590|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23591|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23592|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23593|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23594|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23595|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23596|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23597|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23598|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23599|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23600|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23601|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23602|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23603|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23604|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23605|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23606|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23607|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23608|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23609|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23610|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23611|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23612|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23613|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23614|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23615|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23616|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23617|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23618|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23619|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23620|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23621|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23622|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23623|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23624|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23625|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23626|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23627|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23628|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23629|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23630|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23631|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23632|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23633|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23634|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23635|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23636|NCT02325713|E6|Reported Event|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
23637|NCT02325713|E5|Reported Event|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
23638|NCT02325713|E4|Reported Event|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23639|NCT02325713|E3|Reported Event|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23640|NCT02325713|E2|Reported Event|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
23641|NCT02325713|E1|Reported Event|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
23642|NCT02325518|B3|Baseline|Total|Total of all reporting groups
23643|NCT02325518|B2|Baseline|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
23644|NCT02325518|B1|Baseline|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
23645|NCT02325518|P2|Participant Flow|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
23646|NCT02325518|P1|Participant Flow|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual prostaglandin-analog (PGA) monotherapy, 1 drop in each eye once daily for 8 weeks.
23647|NCT02325518|O2|Outcome|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
23648|NCT02325518|O1|Outcome|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
23649|NCT02325518|O2|Outcome|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
23650|NCT02325518|O1|Outcome|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
23651|NCT02325518|E3|Reported Event|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
23652|NCT02325518|E2|Reported Event|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
23653|NCT02325518|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
23654|NCT02324673|B4|Baseline|Total|Total of all reporting groups
23655|NCT02324673|B3|Baseline|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23656|NCT02324673|B2|Baseline|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23657|NCT02324673|B1|Baseline|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23658|NCT02324673|P3|Participant Flow|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23659|NCT02324673|P2|Participant Flow|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23660|NCT02324673|P1|Participant Flow|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23661|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23662|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23663|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23664|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23665|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23666|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23667|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23668|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23669|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23670|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23781|NCT02322892|E1|Reported Event|Control Arm|"50 mL normal saline solution
Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23671|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23672|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23673|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23674|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23675|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23676|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23677|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23678|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23679|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23680|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23681|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23682|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23683|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23684|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23685|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23686|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23687|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23688|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23689|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23690|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23691|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
24015|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
23692|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23693|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23694|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23695|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23696|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23697|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23698|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23699|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23700|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23701|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23702|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23703|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23704|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23705|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23706|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23707|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23708|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23709|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23710|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23711|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23712|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
24016|NCT02320695|E1|Reported Event|OVERALL|This includes all 60 randomized subjects.
23713|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23714|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23715|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23716|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23717|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23718|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23719|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23720|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23721|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23722|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23723|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23724|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23725|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23726|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23727|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23728|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23729|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23730|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23731|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23732|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23733|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
24017|NCT02320396|B3|Baseline|Total|Total of all reporting groups
23734|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23735|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23736|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23737|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23738|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23739|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23740|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23741|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23742|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23743|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23744|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23745|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23746|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23747|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23748|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23749|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23750|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23751|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23752|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23753|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23754|NCT02324673|O3|Outcome|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
24208|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
23755|NCT02324673|O2|Outcome|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23756|NCT02324673|O1|Outcome|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23757|NCT02324673|E3|Reported Event|High Dose Cannabidiol Oral Solution [40 mg/kg/Day]|High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
23758|NCT02324673|E2|Reported Event|Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]|Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
23759|NCT02324673|E1|Reported Event|Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]|Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
23760|NCT02324660|B1|Baseline|Patients Undergoing Screening and Spirometry|
23761|NCT02324660|P1|Participant Flow|Patients Undergoing Screening and Spirometry|From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if <80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if >19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
23762|NCT02324660|O1|Outcome|Screening Test|"all consecutive patients admitted to our hospital for ACS and current/former smokers will be screened according our protocol with PEF and RHSQ. Patients will be blinded to result of both tests. Indipendently to results, all included patients will receive spirometry (50-70 days after inclusion) to assess the presence or not of COPD (primary outcome).
screening test: screening test with peak expiratory flow and respiratory health screening questionnaire to discriminate patients at risk for COPD"
23763|NCT02324660|O1|Outcome|Patients Undergoing Screening and Spirometry|From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if <80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if >19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
23764|NCT02324660|E1|Reported Event|Patients Undergoing Screening and Spirometry|From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if <80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if >19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
23765|NCT02322892|B3|Baseline|Total|Total of all reporting groups
23766|NCT02322892|B2|Baseline|Thiamine|"200 mg thiamine in 50 mL normal saline solution
Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23767|NCT02322892|B1|Baseline|Control Arm|"50 mL normal saline solution
Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23768|NCT02322892|P2|Participant Flow|Thiamine|"200 mg thiamine in 50 mL normal saline solution
Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23769|NCT02322892|P1|Participant Flow|Control Arm|"50 mL normal saline solution
Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23770|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution
Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23771|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution
Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23772|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution
Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23773|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution
Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23774|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution
Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23775|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution
Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23776|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution
Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23777|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution
Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23778|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution
Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23779|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution
Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
23780|NCT02322892|E2|Reported Event|Thiamine|"200 mg thiamine in 50 mL normal saline solution
Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
35509|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
23784|NCT02322788|P3|Participant Flow|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
23785|NCT02322788|P2|Participant Flow|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
23786|NCT02322788|P1|Participant Flow|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
23787|NCT02322788|O4|Outcome|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
23788|NCT02322788|O3|Outcome|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
23789|NCT02322788|O2|Outcome|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
23790|NCT02322788|O1|Outcome|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
23791|NCT02322788|E4|Reported Event|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
23792|NCT02322788|E3|Reported Event|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
23793|NCT02322788|E2|Reported Event|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
23794|NCT02322788|E1|Reported Event|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
23795|NCT02322775|B3|Baseline|Total|Total of all reporting groups
23796|NCT02322775|B2|Baseline|Placebo|Placebo administered subcutaneously every 4 weeks
23797|NCT02322775|B1|Baseline|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23798|NCT02322775|P2|Participant Flow|Placebo|Placebo administered subcutaneously every 4 weeks
23799|NCT02322775|P1|Participant Flow|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23800|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
23801|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23802|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
23803|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23804|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
23805|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23806|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
23807|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23808|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
23809|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23810|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
23811|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23812|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
23813|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23814|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
23815|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23816|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
23817|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23818|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
23819|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23820|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
23821|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23822|NCT02322775|E2|Reported Event|Placebo|Placebo administered subcutaneously every 4 weeks
23823|NCT02322775|E1|Reported Event|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
23824|NCT02322749|B1|Baseline|Overall Study|All subjects received at least 1 dose of selumetinib. Subjects were randomised in a crossover fashion to receive 1 of 3 treatments during each treatment period: Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4.
23825|NCT02322749|P6|Participant Flow|Sequence CBA|Subjects randomized to treatment sequences CBA: C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
23826|NCT02322749|P5|Participant Flow|Sequence CAB|Subjects randomized to treatment sequences CAB: C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
23827|NCT02322749|P4|Participant Flow|Sequence BCA|Subjects randomized to treatment sequences BCA: B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
23849|NCT02322749|E3|Reported Event|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
25866|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
23850|NCT02322749|E2|Reported Event|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
24212|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
23828|NCT02322749|P3|Participant Flow|Sequence BAC|Subjects randomized to treatment sequences BAC: B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
23829|NCT02322749|P2|Participant Flow|Sequence ACB|Subjects randomized to treatment sequences ACB: A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
23830|NCT02322749|P1|Participant Flow|Sequence ABC|Subjects randomized to treatment sequences ABC: A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
23831|NCT02322749|O3|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23832|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23833|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23834|NCT02322749|O3|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23835|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23836|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23837|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23838|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23839|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23840|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23841|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23842|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23843|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23844|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23845|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23846|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23847|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23848|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
35510|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
23851|NCT02322749|E1|Reported Event|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
23852|NCT02322528|B1|Baseline|Administration of Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
23853|NCT02322528|P1|Participant Flow|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
23854|NCT02322528|O1|Outcome|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
23855|NCT02322528|O1|Outcome|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
23856|NCT02322528|E1|Reported Event|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
23857|NCT02322216|B3|Baseline|Total|Total of all reporting groups
23858|NCT02322216|B2|Baseline|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
23859|NCT02322216|B1|Baseline|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
23860|NCT02322216|P2|Participant Flow|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
23861|NCT02322216|P1|Participant Flow|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
23862|NCT02322216|O2|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
23863|NCT02322216|O1|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
23864|NCT02322216|E3|Reported Event|PATANOL|All subjects treated with olopatadine hydrochloride ophthalmic solution 0.1%
23865|NCT02322216|E2|Reported Event|PATADAY|All subjects treated with olopatadine hydrochloride ophthalmic solution 0.2%
23866|NCT02322216|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
23867|NCT02321527|B1|Baseline|CEUS Sentinel Lymph Node Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
23868|NCT02321527|P1|Participant Flow|CEUS SNL Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node (SNL) biopsy and radioactive seed placement.
23869|NCT02321527|O1|Outcome|CEUS Sentinel Lymph Node Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
23870|NCT02321527|E1|Reported Event|CEUS Sentinel Lymph Node Imaging + Guided Biopsy|Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
23871|NCT02321436|B3|Baseline|Total Title|
23872|NCT02321436|B2|Baseline|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
23873|NCT02321436|B1|Baseline|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
23874|NCT02321436|P2|Participant Flow|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
23875|NCT02321436|P1|Participant Flow|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single intramuscular (IM) injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 millilitre (mL).
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
23876|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
23965|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
35511|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
23969|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
24213|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
23877|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
23878|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
23879|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
23880|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
23881|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
23882|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
23883|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
23884|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
23885|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
23886|NCT02321436|O2|Outcome|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
23887|NCT02321436|O1|Outcome|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
23888|NCT02321436|E2|Reported Event|Placebo|Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
23889|NCT02321436|E1|Reported Event|Dysport ® 500 U|"Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject’s last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit."
23890|NCT02320838|B1|Baseline|All Participants|Participants who were randomized to receive either 5 KHz, TENS or Sham Stimulation
23966|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23891|NCT02320838|P5|Participant Flow|5 KHz First, Then Sham and Then TENS|"5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds.
Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
23892|NCT02320838|P4|Participant Flow|TENS First, Then Sham and Then 5KHz|"ENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
23893|NCT02320838|P3|Participant Flow|Sham First, Then TENS and Then 5KHz|"Sham stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold."
23894|NCT02320838|P2|Participant Flow|TENS First, Then 5 KHz and Then Sham|"TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
23895|NCT02320838|P1|Participant Flow|5 KHz First, Then TENS and Then Sham|"5KHz: Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
TENS: Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds.
Sham Stimulation: Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel."
23896|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23897|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23898|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23899|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23900|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23967|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23901|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23902|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23903|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23904|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23905|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23906|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23907|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23908|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23909|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23910|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23911|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23912|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23913|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23914|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23915|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
25867|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
23916|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23917|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23918|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23919|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23920|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23921|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23922|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23923|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23924|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23925|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23926|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23927|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23928|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23929|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23930|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
25868|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
23931|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23932|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23933|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23934|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23935|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23936|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23937|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23938|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23939|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23940|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23941|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23942|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23943|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23944|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23945|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23946|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23947|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23948|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23949|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23950|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23951|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23952|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23953|NCT02320838|O3|Outcome|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23954|NCT02320838|O2|Outcome|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23955|NCT02320838|O1|Outcome|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23956|NCT02320838|E3|Reported Event|Sham Stimulation|"Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
Sham stimulation: Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23957|NCT02320838|E2|Reported Event|TENS|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds
TENS: TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23958|NCT02320838|E1|Reported Event|5 KHz|"Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a “strong but comfortable sensation, just below motor threshold.
5 KHz: 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)"
23959|NCT02320721|B3|Baseline|Total|Total of all reporting groups
23960|NCT02320721|B2|Baseline|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23961|NCT02320721|B1|Baseline|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23962|NCT02320721|P2|Participant Flow|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23963|NCT02320721|P1|Participant Flow|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23964|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23970|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23971|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23972|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23973|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23974|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23975|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23976|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23977|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23978|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23979|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23980|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23981|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23982|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23983|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23984|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23985|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23986|NCT02320721|O2|Outcome|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23987|NCT02320721|O1|Outcome|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23988|NCT02320721|E2|Reported Event|Lantus|Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23989|NCT02320721|E1|Reported Event|HOE901-U300|HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
23990|NCT02320695|B1|Baseline|OVERALL|This includes all 60 randomized subjects. Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
23991|NCT02320695|P1|Participant Flow|OVERALL|Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
23992|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
23993|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
23994|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
23995|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
23996|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
23997|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
23998|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
23999|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
24000|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
24001|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
24002|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
24003|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
24004|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
24005|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
24006|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
24007|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
24008|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
24009|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
24010|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
24011|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
24012|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
25869|NCT02305277|E6|Reported Event|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
24211|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
24018|NCT02320396|B2|Baseline|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24019|NCT02320396|B1|Baseline|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24020|NCT02320396|P2|Participant Flow|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24021|NCT02320396|P1|Participant Flow|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24022|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24023|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24024|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24025|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24026|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24027|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24028|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24029|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24030|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24031|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24032|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24033|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24034|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24035|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24036|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24037|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24038|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24039|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24040|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24041|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24042|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24131|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24043|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24044|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24045|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24046|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24047|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24048|NCT02320396|E2|Reported Event|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24049|NCT02320396|E1|Reported Event|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
24050|NCT02320227|B1|Baseline|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
24051|NCT02320227|P1|Participant Flow|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
24052|NCT02320227|O1|Outcome|Miami w/o Frag Personal Lubricant|Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks.
24053|NCT02320227|O1|Outcome|Miami w/o Frag Personal Lubricant|Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks
24054|NCT02320227|E1|Reported Event|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
24055|NCT02320214|B1|Baseline|Novel Lubricant Miami w/ Frag Personal Lubricant|Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
24056|NCT02320214|P1|Participant Flow|Novel Lubricant Miami w/ Frag Personal Lubricant|Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
24057|NCT02320214|O1|Outcome|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
24058|NCT02320214|O1|Outcome|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
24059|NCT02320214|E1|Reported Event|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
24060|NCT02319824|B1|Baseline|Treatment (Radiation and NY-ESO-1-specific T Cells)|"Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
Autologous NY-ESO-1-specific CD8-positive T Lymphocytes"
24061|NCT02319824|P1|Participant Flow|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells IV 2-3 days after completion of radiation therapy.
24062|NCT02319824|O1|Outcome|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
24063|NCT02319824|O1|Outcome|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
24064|NCT02319824|O1|Outcome|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells I60 minutes 2-3 days after completion of radiation therapy.
24065|NCT02319824|E1|Reported Event|Treatment (Radiation and NY-ESO-1-specific T Cells)|Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
24066|NCT02319668|B3|Baseline|Total|Total of all reporting groups
24067|NCT02319668|B2|Baseline|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
24068|NCT02319668|B1|Baseline|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
24069|NCT02319668|P2|Participant Flow|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
24070|NCT02319668|P1|Participant Flow|Test and Reference Product|Participants rinsed for one timed minute with 10 milliliter (mL) of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
24209|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
24071|NCT02319668|O2|Outcome|Reference Product|Participants did not receive any product (mouthwash containing Chlorhexidine digluconate or toothpaste containing sodium fluoride) during analysis of this outcome as this analysis was performed at baseline.
24072|NCT02319668|O1|Outcome|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product only (mouthwash containing Chlorhexidine digluconate). Participants did not receive reference product(toothpaste containing sodium fluoride) during analysis of this outcome as this analysis was performed at baseline.
24073|NCT02319668|O2|Outcome|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
24074|NCT02319668|O1|Outcome|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
24075|NCT02319668|O2|Outcome|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
24076|NCT02319668|O1|Outcome|Test and Reference Products|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
24077|NCT02319668|O2|Outcome|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
24078|NCT02319668|O1|Outcome|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
24079|NCT02319668|E2|Reported Event|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
24080|NCT02319668|E1|Reported Event|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brushed prior to using mouthwash).
24081|NCT02319525|B3|Baseline|Total|Total of all reporting groups
24082|NCT02319525|B2|Baseline|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
24083|NCT02319525|B1|Baseline|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
24084|NCT02319525|P2|Participant Flow|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
24085|NCT02319525|P1|Participant Flow|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
24086|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
24087|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
24088|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
24089|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
24090|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
24091|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
24092|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
24093|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
24094|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
24095|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
24096|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
24097|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
24098|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
24099|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
24100|NCT02319525|E2|Reported Event|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
24101|NCT02319525|E1|Reported Event|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
24132|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24210|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
24102|NCT02319486|B1|Baseline|CEV With/Without Carboplatin|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection
carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection
CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
24103|NCT02319486|P1|Participant Flow|CEV With/Without Carboplatin|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection
carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection
CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
24104|NCT02319486|O2|Outcome|CEV With/Without Carboplatin - Stage 3|CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2
24105|NCT02319486|O1|Outcome|CEV With/Without Carboplatin- Stage 2|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection
carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection
CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
24106|NCT02319486|E2|Reported Event|CEV With/Without Carboplatin-Stage 3|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection
carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection
CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
24107|NCT02319486|E1|Reported Event|CEV With/Without Carboplatin-Stage 2|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection
carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection
CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
24108|NCT02319148|B4|Baseline|Total|Total of all reporting groups
24109|NCT02319148|B3|Baseline|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24110|NCT02319148|B2|Baseline|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24111|NCT02319148|B1|Baseline|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24112|NCT02319148|P4|Participant Flow|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24113|NCT02319148|P3|Participant Flow|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24114|NCT02319148|P2|Participant Flow|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24115|NCT02319148|P1|Participant Flow|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24116|NCT02319148|O7|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24117|NCT02319148|O6|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24118|NCT02319148|O5|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24119|NCT02319148|O4|Outcome|Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days.
24120|NCT02319148|O3|Outcome|Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days.
24121|NCT02319148|O2|Outcome|Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days.
24122|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24123|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24124|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24125|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24126|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24127|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24128|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24129|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24130|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24203|NCT02318693|B2|Baseline|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
24133|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24134|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24135|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24136|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24137|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24138|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24139|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24140|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24141|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24142|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24143|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24144|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24145|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24146|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24147|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24148|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24149|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24150|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24151|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24152|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24153|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24154|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24155|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24156|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24157|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24158|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24159|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24160|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24161|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24162|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24163|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
24164|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24165|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24166|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24167|NCT02319148|E7|Reported Event|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
25870|NCT02305277|E5|Reported Event|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
24168|NCT02319148|E6|Reported Event|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
24169|NCT02319148|E5|Reported Event|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
24170|NCT02319148|E4|Reported Event|Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days.
24171|NCT02319148|E3|Reported Event|Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days.
24172|NCT02319148|E2|Reported Event|Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days.
24173|NCT02319148|E1|Reported Event|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
24174|NCT02319031|B3|Baseline|Total|Total of all reporting groups
24175|NCT02319031|B2|Baseline|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24176|NCT02319031|B1|Baseline|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24177|NCT02319031|P2|Participant Flow|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24178|NCT02319031|P1|Participant Flow|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24179|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24180|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24181|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24182|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24204|NCT02318693|B1|Baseline|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
24205|NCT02318693|P2|Participant Flow|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.
25871|NCT02305277|E4|Reported Event|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
24183|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24184|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24185|NCT02319031|E2|Reported Event|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24186|NCT02319031|E1|Reported Event|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
24187|NCT02318940|B3|Baseline|Total|Total of all reporting groups
24188|NCT02318940|B2|Baseline|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided"
24189|NCT02318940|B1|Baseline|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided"
24190|NCT02318940|P2|Participant Flow|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided"
24191|NCT02318940|P1|Participant Flow|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided"
24192|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided"
24193|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided"
24194|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided"
24195|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided"
24196|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided"
24197|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided"
24198|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided"
24199|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided"
24200|NCT02318940|E2|Reported Event|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided"
24201|NCT02318940|E1|Reported Event|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided"
24202|NCT02318693|B3|Baseline|Total|Total of all reporting groups
25872|NCT02305277|E3|Reported Event|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
24214|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
24215|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
24216|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
24217|NCT02318693|E2|Reported Event|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
24218|NCT02318693|E1|Reported Event|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
24219|NCT02318303|B8|Baseline|Total|Total of all reporting groups
24220|NCT02318303|B7|Baseline|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS administered as 2 sprays/nostril
24221|NCT02318303|B6|Baseline|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS administered as 2 sprays/nostril
24222|NCT02318303|B5|Baseline|GSP 301-2 NS (BID)|GSP 301-2 NS administered as 2 sprays/nostril
24223|NCT02318303|B4|Baseline|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS administered as 2 sprays/nostril
24224|NCT02318303|B3|Baseline|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS administered as 2 sprays/nostril
24225|NCT02318303|B2|Baseline|GSP 301-1 NS (QD)|GSP 301-1 NS administered as 2 sprays/nostril
24226|NCT02318303|B1|Baseline|GSP 301 Placebo NS|GSP 301 placebo NS administered as 2 sprays/nostril
24227|NCT02318303|P7|Participant Flow|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
24228|NCT02318303|P6|Participant Flow|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril
24229|NCT02318303|P5|Participant Flow|GSP 301-2 NS (BID)|GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
24230|NCT02318303|P4|Participant Flow|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
24231|NCT02318303|P3|Participant Flow|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS (50 μg) administered as 2 sprays/nostril
24232|NCT02318303|P2|Participant Flow|GSP 301-1 NS (QD)|GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
24233|NCT02318303|P1|Participant Flow|GSP 301 Placebo NS|GSP 301 placebo NS administered as 2 sprays/nostril
24234|NCT02318303|O7|Outcome|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS (BID) administered as 2 sprays/nostril
24235|NCT02318303|O6|Outcome|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS (BID) administered as 2 sprays/nostril
24236|NCT02318303|O5|Outcome|GSP 301-2 NS (BID)|GSP 301-2 NS (BID) administered as 2 sprays/nostril
24237|NCT02318303|O4|Outcome|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS (QD) administered as 2 sprays/nostril
24238|NCT02318303|O3|Outcome|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS (QD) administered as 2 sprays/nostril
24239|NCT02318303|O2|Outcome|GSP 301-1 NS (QD)|GSP 301-1 NS (QD) administered as 2 sprays/nostril
24240|NCT02318303|O1|Outcome|GSP 301 Placebo|GSP 301 placebo NS administered as 2 sprays/nostril
24241|NCT02318303|E7|Reported Event|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS (BID) administered as 2 sprays/nostril
24242|NCT02318303|E6|Reported Event|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS (BID) administered as 2 sprays/nostril
24243|NCT02318303|E5|Reported Event|GSP 301-2 NS (BID)|GSP 301-2 NS (BID) administered as 2 sprays/nostril.
24244|NCT02318303|E4|Reported Event|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS (QD) administered as 2 sprays/nostril
24245|NCT02318303|E3|Reported Event|Mometasone Furoate-1 NS (QD)|Mometasone furoate-1 NS (QD) administered as 2 sprays/nostril
24246|NCT02318303|E2|Reported Event|GSP 301-1 NS (QD)|GSP 301-1 NS (QD) administered as 2 sprays/nostril
24247|NCT02318303|E1|Reported Event|GSP 301 Placebo NS|GSP 301 placebo NS administered as 2 sprays/nostril
24248|NCT02317809|B1|Baseline|All Subjects|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector or 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first or second intervention period.
24249|NCT02317809|P2|Participant Flow|First Freeze-dried Pergoveris, Then Liquid Pergoveris|Subjects were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
24250|NCT02317809|P1|Participant Flow|First Liquid Pergoveris, Then Freeze-dried Pergoveris|Subjects were administered with 900 international units (IU) of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
24251|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24252|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24253|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24254|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24361|NCT02316678|B1|Baseline|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy
No intervention: There is no intervention"
24255|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24256|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24257|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24258|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24259|NCT02317809|O2|Outcome|First Freeze-dried Pergoveris, Then Liquid Pergoveris|Subjects were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
24260|NCT02317809|O1|Outcome|First Liquid Pergoveris, Then Freeze-dried Pergoveris|Subjects were administered with 900 international units (IU) of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
24261|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24262|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24263|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24264|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24265|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24266|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24267|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24268|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24269|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24270|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24271|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24272|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24273|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24274|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24275|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24276|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24277|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24278|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24279|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24280|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24281|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24282|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24283|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24284|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24285|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24286|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24287|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24288|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24289|NCT02317809|E2|Reported Event|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
24290|NCT02317809|E1|Reported Event|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
24291|NCT02317510|B3|Baseline|Total|Total of all reporting groups
24292|NCT02317510|B2|Baseline|Group 2|"Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).
general anesthesia: General anesthesia for laparoscopic cholecystectomy"
24293|NCT02317510|B1|Baseline|Group 1|"Laparoscopic cholecystectomy in General Anesthesia
combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy"
24294|NCT02317510|P2|Participant Flow|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
24295|NCT02317510|P1|Participant Flow|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24296|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
24297|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24298|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
24299|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24300|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
24301|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24302|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
24303|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24304|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
24305|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24306|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
24307|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24308|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
24309|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24310|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
24311|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24312|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
24313|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24314|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
24315|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24316|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
24317|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
24318|NCT02317510|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).
general anesthesia: General anesthesia for laparoscopic cholecystectomy"
24319|NCT02317510|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in General Anesthesia
combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy"
24320|NCT02317510|E2|Reported Event|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
24321|NCT02317510|E1|Reported Event|Group 1|Laparoscopic cholecystectomy in General Anesthesia
41615|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
24322|NCT02317016|B1|Baseline|Rosuvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of rosuvastatin alone, followed by AZD9291 alone, followed by rosuvastatin + AZD9291. Each patient received 20 mg single oral doses of rosuvastatin on Day 1 and Day 32, and 80 mg oral doses of AZD9291 tablets once daily for 31 days (Days 4 to 34).
In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
24323|NCT02317016|P1|Participant Flow|Rosuvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of rosuvastatin alone, followed by AZD9291 alone, followed by rosuvastatin + AZD9291. Each patient received 20 mg single oral doses of rosuvastatin on Day 1 and Day 32, and 80 mg oral doses of AZD9291 tablets once daily for 31 days (Days 4 to 34).
In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
24324|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24325|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24326|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24327|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24328|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24329|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24330|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24331|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24332|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
24333|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24334|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
24362|NCT02316678|P2|Participant Flow|Corticosteroids - no Intervention|"Patients initiating corticosteroids
No intervention: There is no intervention"
41616|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
24335|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24336|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
24337|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24338|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
24339|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24340|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
24341|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24342|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
24343|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
24344|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
24345|NCT02317016|E3|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
24346|NCT02317016|E2|Reported Event|Part A Safety Population|In Part A of the study, each patient received 80 mg oral doses of AZD9291 tablets once daily for 31 days (Days 4 to 34) and single 20 mg oral doses of rosuvastatin on Day 1 and Day 32.
24347|NCT02317016|E1|Reported Event|Overall Safety Population|Parts A and B of the study combined.
24348|NCT02316769|B3|Baseline|Total|Total of all reporting groups
24349|NCT02316769|B2|Baseline|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope
Intubation with the McGrath MAC video laryngoscope"
24350|NCT02316769|B1|Baseline|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope
Intubation with the King Vision video laryngoscope"
24351|NCT02316769|P2|Participant Flow|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope
Intubation with the McGrath MAC video laryngoscope"
24352|NCT02316769|P1|Participant Flow|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope
Intubation with the King Vision video laryngoscope"
24353|NCT02316769|O2|Outcome|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope
Intubation with the McGrath MAC video laryngoscope"
24354|NCT02316769|O1|Outcome|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope
Intubation with the King Vision video laryngoscope"
24355|NCT02316769|O2|Outcome|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope
Intubation with the McGrath MAC video laryngoscope"
24356|NCT02316769|O1|Outcome|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope
Intubation with the King Vision video laryngoscope"
24357|NCT02316769|E2|Reported Event|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope
Intubation with the McGrath MAC video laryngoscope"
24358|NCT02316769|E1|Reported Event|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope
Intubation with the King Vision video laryngoscope"
24359|NCT02316678|B3|Baseline|Total|Total of all reporting groups
24360|NCT02316678|B2|Baseline|Corticosteroids - no Intervention|"Patients initiating corticosteroids
No intervention: There is no intervention"
25873|NCT02305277|E2|Reported Event|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
24363|NCT02316678|P1|Participant Flow|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy
No intervention: There is no intervention"
24364|NCT02316678|O2|Outcome|Steroids|Prolonged users of steroids defined as either >3000 mg of prednisone (or equivalent) or >600 mg of budesonide divided between ≥2 prescriptions within 12 months and absence of any anti-TNF therapy during the same 12 months.
24365|NCT02316678|O1|Outcome|Anti-TNF|New users of anti-TNF therapy defined as ≥ 1 dispensing for an anti-TNF drug with ≥1 filled CS prescription and no dispensing for any anti-TNF medication in the 12 months preceding the first anti-TNF dispensing.
24366|NCT02316678|E2|Reported Event|Corticosteroids - no Intervention|"Patients initiating corticosteroids
No intervention: There is no intervention"
24367|NCT02316678|E1|Reported Event|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy
No intervention: There is no intervention"
24368|NCT02316613|B1|Baseline|All Participants|Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24369|NCT02316613|P1|Participant Flow|All Participants|Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24370|NCT02316613|O2|Outcome|Maintenance Therapy|During maintenance therapy the participants received or did not received treatment with the MabThera.
24371|NCT02316613|O1|Outcome|First Induction|During the induction period participants received either MabThera monotherapy, MabThera combination therapy (chemotherapy and at least one cycle with MabThera), or all cycles performed without MabThera administration.
24372|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24373|NCT02316613|O1|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
24374|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
24375|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
24376|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
24377|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
24378|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
24379|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
24380|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
24381|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
24382|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
24383|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
24384|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
24385|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
24478|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24432|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24386|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24387|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24388|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24389|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24390|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24391|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24392|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24393|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received MabThera maintenance therapy after the first study induction was reported.
24394|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received MabThera treatment over the first study induction period was reported.
24395|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24396|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24397|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24398|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
24399|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
24400|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
24401|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
24402|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment.
24403|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24404|NCT02316613|E1|Reported Event|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
24405|NCT02316470|B5|Baseline|Total|Total of all reporting groups
24406|NCT02316470|B4|Baseline|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24407|NCT02316470|B3|Baseline|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24408|NCT02316470|B2|Baseline|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24409|NCT02316470|B1|Baseline|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24410|NCT02316470|P4|Participant Flow|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28
Placebo: phosphate buffered saline (PBS) solution"
24411|NCT02316470|P3|Participant Flow|VLA84 200 mcg w/ Alum|"VLA84 200 mcg w/ (with) Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24412|NCT02316470|P2|Participant Flow|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24413|NCT02316470|P1|Participant Flow|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 1 injection of 0.75 mL (milliliters) VLA84 w/o Alum and 1 injection of 0.75 mL Placebo Vaccination Days: 0, 7 and 28
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24414|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24415|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24416|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24417|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24418|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24419|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24420|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24421|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24422|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24423|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24424|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24425|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24426|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24427|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24428|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24429|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24430|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24431|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24733|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24433|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24434|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24435|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24436|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24437|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24438|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24439|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24440|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24441|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24442|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24443|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24444|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24445|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24446|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24447|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24448|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24449|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24450|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24451|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24452|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24453|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24454|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
25414|NCT02310581|P4|Participant Flow|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
24455|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24456|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24457|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24458|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24459|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24460|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24461|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24462|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24463|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24464|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24465|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24466|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24467|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24468|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24469|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24470|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24471|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24472|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24473|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24474|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24475|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24476|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24477|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
35512|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
24479|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24480|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24481|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24482|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24483|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24484|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24485|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24486|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24487|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24488|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24489|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24490|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24491|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24492|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24493|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24494|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24495|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24496|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24497|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24498|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
24499|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24500|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24501|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
35513|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
24502|NCT02316470|E4|Reported Event|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution"
41617|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
24503|NCT02316470|E3|Reported Event|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24504|NCT02316470|E2|Reported Event|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
24505|NCT02316470|E1|Reported Event|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution"
24506|NCT02316366|B3|Baseline|Total|Total of all reporting groups
24507|NCT02316366|B2|Baseline|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
24508|NCT02316366|B1|Baseline|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer
Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
24509|NCT02316366|P2|Participant Flow|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
24510|NCT02316366|P1|Participant Flow|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer
Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
24511|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
24512|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer
Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
24513|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
24514|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer
Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
24515|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
24516|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer
Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
24517|NCT02316366|E2|Reported Event|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
24518|NCT02316366|E1|Reported Event|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer
Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
24519|NCT02315989|B1|Baseline|Safety|"proton therapy
proton therapy: proton therapy"
24520|NCT02315989|P1|Participant Flow|Safety|"proton therapy
proton therapy: proton therapy"
24521|NCT02315989|O3|Outcome|Inevaluable|Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).
24522|NCT02315989|O2|Outcome|Partial Response|Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
24523|NCT02315989|O1|Outcome|Stable Disease|Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
24524|NCT02315989|O1|Outcome|The Frequency of Operation of the System Error|6 subjects received a total of 165 proton therapy, a total of 21 times the system running abnormalities. There was no correlation between system abnormalities during the study and the adverse events.
24525|NCT02315989|O1|Outcome|Safety|"proton therapy
proton therapy: proton therapy"
24526|NCT02315989|E1|Reported Event|Safety|"proton therapy
proton therapy: proton therapy"
24527|NCT02315352|B3|Baseline|Total|Total of all reporting groups
24528|NCT02315352|B2|Baseline|Rac-PZQ Then L-PZQ (Day 1)|Rac-PZQ 150 mg ODT in first intervention period followed by L-PZQ 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24529|NCT02315352|B1|Baseline|L-PZQ Then Rac-PZQ (Day 1)|L- Praziquantel (L-PZQ) 150 milligram (mg) oral disintegrating tablet (ODT) in first intervention period followed by racemate praziquantel (Rac-PZQ) 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24540|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24541|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
35514|NCT02204579|O1|Outcome|NPSP795|
24734|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
41618|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
24530|NCT02315352|P8|Participant Flow|Cesol® Then Rac-PZQ Then L-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Cesol® 150 mg as a suspension via a syringe in the buccal cavity in third intervention period followed by Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24531|NCT02315352|P7|Participant Flow|Cesol® Then L-PZQ Then Rac-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Cesol® 150 mg as a suspension via a syringe in the buccal cavity in third intervention period followed by L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Rac -PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24532|NCT02315352|P6|Participant Flow|Rac-PZQ Then L-PZQ Then Cesol® (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Rac-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24533|NCT02315352|P5|Participant Flow|Rac-PZQ Then Cesol® Then L-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Rac-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in fourth intervention period and then L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24534|NCT02315352|P4|Participant Flow|L-PZQ Then Cesol® Then Rac-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received L-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in fourth intervention period and then Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24535|NCT02315352|P3|Participant Flow|L-PZQ Then Rac-PZQ Then Cesol® (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received L-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Cesol® (currently available praziquantel tablet) 150 mg administered as a suspension via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24536|NCT02315352|P2|Participant Flow|Rac-PZQ Then L-PZQ (Day 1)|Subjects were administered Rac-PZQ 150 mg ODT in first intervention period followed by L-PZQ 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24537|NCT02315352|P1|Participant Flow|L-PZQ Then Rac-PZQ (Day 1)|Subjects were administered L- Praziquantel (L-PZQ) 150 milligram (mg) oral disintegrating tablet (ODT) in first intervention period followed by racemate praziquantel (Rac-PZQ) 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24538|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
24539|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24611|NCT02314520|B3|Baseline|Total|Total of all reporting groups
24542|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24543|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
24544|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24545|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24546|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24547|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24548|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
24549|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24550|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24551|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24552|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24553|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
24554|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24555|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24556|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24557|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24558|NCT02315352|E5|Reported Event|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
24559|NCT02315352|E4|Reported Event|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
24560|NCT02315352|E3|Reported Event|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
35515|NCT02204579|O1|Outcome|NPSP795|
24561|NCT02315352|E2|Reported Event|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24562|NCT02315352|E1|Reported Event|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
24563|NCT02314689|B1|Baseline|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
24564|NCT02314689|P1|Participant Flow|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
24565|NCT02314689|O1|Outcome|IV Citrulline|"IV citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
Intravenous (IV) citrulline"
24566|NCT02314689|E1|Reported Event|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
24567|NCT02314637|B3|Baseline|Total|Total of all reporting groups
24568|NCT02314637|B2|Baseline|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
24569|NCT02314637|B1|Baseline|Teneligliptin|Teneligliptin for 52 weeks
24570|NCT02314637|P2|Participant Flow|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea (glimepiride)
24571|NCT02314637|P1|Participant Flow|Teneligliptin|Teneligliptin for 52 weeks
24572|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
24573|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
24574|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
24575|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
24576|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
24577|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
24578|NCT02314637|E2|Reported Event|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
24579|NCT02314637|E1|Reported Event|Teneligliptin|Teneligliptin for 52 weeks
24580|NCT02314546|B4|Baseline|Total|Total of all reporting groups
24581|NCT02314546|B3|Baseline|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
24582|NCT02314546|B2|Baseline|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
24583|NCT02314546|B1|Baseline|Saline Placebo|Control patients received intranasal saline.
24584|NCT02314546|P3|Participant Flow|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
24585|NCT02314546|P2|Participant Flow|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
24586|NCT02314546|P1|Participant Flow|Saline Placebo|Control patients received intranasal saline.
24587|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
24588|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
24589|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
24590|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
24591|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
24592|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
24593|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
24594|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
24595|NCT02314546|O1|Outcome|Saline Placebo|Control patients will received intranasal saline.
24596|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
24597|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
24598|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
24599|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
24600|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
24601|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
24602|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
24603|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
24604|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
24605|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
24606|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
24607|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
24608|NCT02314546|E3|Reported Event|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
24609|NCT02314546|E2|Reported Event|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
24610|NCT02314546|E1|Reported Event|Saline Placebo|Control patients received intranasal saline.
24612|NCT02314520|B2|Baseline|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication"
24613|NCT02314520|B1|Baseline|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access"
24614|NCT02314520|P2|Participant Flow|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication"
24615|NCT02314520|P1|Participant Flow|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access"
24616|NCT02314520|O2|Outcome|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication"
24617|NCT02314520|O1|Outcome|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access"
24618|NCT02314520|O2|Outcome|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication"
24619|NCT02314520|O1|Outcome|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access"
24620|NCT02314520|O2|Outcome|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication"
24621|NCT02314520|O1|Outcome|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access"
24622|NCT02314520|O2|Outcome|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication"
24623|NCT02314520|O1|Outcome|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access"
24624|NCT02314520|E2|Reported Event|Central Line|"Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication"
24625|NCT02314520|E1|Reported Event|PICC|"Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access"
24626|NCT02314260|B1|Baseline|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.
bishop score calculation: Assessment of bishop score by vaginal examination
Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.
Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score
labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
24627|NCT02314260|P1|Participant Flow|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.
bishop score calculation: Assessment of bishop score by vaginal examination
Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.
Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score
labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
24628|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.
bishop score calculation: Assessment of bishop score by vaginal examination
Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.
Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score
labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
24629|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.
bishop score calculation: Assessment of bishop score by vaginal examination
Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.
Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score
labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
24630|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.
bishop score calculation: Assessment of bishop score by vaginal examination
Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.
Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score
labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
24651|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
35516|NCT02204579|O1|Outcome|NPSP795|
24631|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.
bishop score calculation: Assessment of bishop score by vaginal examination
Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.
Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score
labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
24632|NCT02314260|E1|Reported Event|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.
bishop score calculation: Assessment of bishop score by vaginal examination
Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.
Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score
labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
24633|NCT02314104|B4|Baseline|Total|Total of all reporting groups
24634|NCT02314104|B3|Baseline|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24635|NCT02314104|B2|Baseline|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24636|NCT02314104|B1|Baseline|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24637|NCT02314104|P3|Participant Flow|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24638|NCT02314104|P2|Participant Flow|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24639|NCT02314104|P1|Participant Flow|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24640|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24641|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24642|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24643|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24644|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24645|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24646|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24647|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24648|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24649|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24650|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24726|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
35517|NCT02204579|O1|Outcome|NPSP795|
24652|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24653|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24654|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24655|NCT02314104|E3|Reported Event|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24656|NCT02314104|E2|Reported Event|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24657|NCT02314104|E1|Reported Event|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.
ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
24658|NCT02313766|B4|Baseline|Total|Total of all reporting groups
24659|NCT02313766|B3|Baseline|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%
PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
24660|NCT02313766|B2|Baseline|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%
PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
24661|NCT02313766|B1|Baseline|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.
End of preoxygenation FEO2=90%"
24662|NCT02313766|P3|Participant Flow|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%
PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
24663|NCT02313766|P2|Participant Flow|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%
PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
24664|NCT02313766|P1|Participant Flow|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.
End of preoxygenation FEO2=90%"
24665|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%
PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
24666|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%
PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
24667|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.
End of preoxygenation FEO2=90%"
24668|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%
PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
24727|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24669|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%
PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
24670|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.
End of preoxygenation FEO2=90%"
24671|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%
PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
24672|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%
PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
24673|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.
End of preoxygenation FEO2=90%"
24674|NCT02313766|E3|Reported Event|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%
PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
24675|NCT02313766|E2|Reported Event|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.
Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%
PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
24676|NCT02313766|E1|Reported Event|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.
End of preoxygenation FEO2=90%"
24677|NCT02313558|B3|Baseline|Total|Total of all reporting groups
24678|NCT02313558|B2|Baseline|Control Dentifrice|"use the control dentifrice to brush teeth twice daily for 12 weeks
Control dentifrice: Use the dentifrice to brush teeth twice a day for 12 weeks"
24679|NCT02313558|B1|Baseline|Dentifrice Containing Ilex Rotunda Thunb|"use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
Dentifrice Containing Ilex Rotunda Thunb: Use the dentifrice to brush teeth twice a day for 12 weeks"
24680|NCT02313558|P2|Participant Flow|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
24681|NCT02313558|P1|Participant Flow|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
24682|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
24683|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
24684|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
24685|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
24686|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
24687|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
24688|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
24689|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
24690|NCT02313558|E2|Reported Event|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
24691|NCT02313558|E1|Reported Event|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
24692|NCT02313233|B3|Baseline|Total|Total of all reporting groups
24693|NCT02313233|B2|Baseline|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
24728|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24729|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24730|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
25874|NCT02305277|E1|Reported Event|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
24694|NCT02313233|B1|Baseline|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
24695|NCT02313233|P2|Participant Flow|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
24696|NCT02313233|P1|Participant Flow|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is given as add-on therapy for benigh prostate hyperplasia (BPH). All the subjects have the history for this medical condition and receive the medication. Each subject receives Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
24697|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
24698|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of the study product was given 2 tablets with about 240 ml of water."
24699|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
24700|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
24701|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
24702|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
24703|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
24704|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
24705|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
24731|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24732|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
25694|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
24706|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
24707|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
24708|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
24709|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
24710|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
24711|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
24712|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
24713|NCT02313233|E2|Reported Event|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
24714|NCT02313233|E1|Reported Event|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
24715|NCT02313155|B3|Baseline|Total|Total of all reporting groups
24716|NCT02313155|B2|Baseline|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24717|NCT02313155|B1|Baseline|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24718|NCT02313155|P2|Participant Flow|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24719|NCT02313155|P1|Participant Flow|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24720|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24721|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24722|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24723|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24724|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24725|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24735|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24736|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24737|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24738|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24739|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24740|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24741|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24742|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24743|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24744|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24745|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24746|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24747|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24748|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24749|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24750|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24751|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24752|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24753|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24754|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24755|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24756|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24757|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24758|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24759|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24760|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24761|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24762|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24763|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24764|NCT02313155|E2|Reported Event|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
24765|NCT02313155|E1|Reported Event|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
24766|NCT02312739|B3|Baseline|Total|Total of all reporting groups
24767|NCT02312739|B2|Baseline|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure
Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
25695|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
24843|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
24768|NCT02312739|B1|Baseline|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
24769|NCT02312739|P2|Participant Flow|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure
Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
24770|NCT02312739|P1|Participant Flow|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
24771|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure
Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
24772|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
24773|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure
Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
24774|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
24775|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure
Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
24776|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
24791|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24777|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure
Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
24778|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
24779|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure
Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
24780|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
24781|NCT02312739|E2|Reported Event|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure
Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
24782|NCT02312739|E1|Reported Event|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.
All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.
Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure
Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
24783|NCT02312726|B1|Baseline|Total Participants Enrolled in Study|Participant characteristics for those enrolled in the study, in both the epidural and non-epidural group
24784|NCT02312726|P3|Participant Flow|Excluded|Participants who did not meet inclusion criteria or declined after consent.
24785|NCT02312726|P2|Participant Flow|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24786|NCT02312726|P1|Participant Flow|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24787|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24788|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24789|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24790|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24839|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
25696|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
24792|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24793|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24794|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24795|NCT02312726|E2|Reported Event|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24796|NCT02312726|E1|Reported Event|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion
Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
24797|NCT02312154|B1|Baseline|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
24798|NCT02312154|P1|Participant Flow|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
24799|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
24800|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
24801|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
24802|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
24803|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
24804|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
24805|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
24806|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
24807|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
24808|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
24809|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
24810|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
24811|NCT02312154|E1|Reported Event|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
24812|NCT02311972|B3|Baseline|Total|Total of all reporting groups
24813|NCT02311972|B2|Baseline|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|The nurse will insert an InnerSense temperature sensor/feeding tube per normal standards as soon after birth as possible, during delivery room stabilization. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. All temperatures entered into the study database.
24814|NCT02311972|B1|Baseline|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on admission, and at 1, 4, 8 and 24 hours. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age for each infant in both groups on a data sheet at the bedside. These data will be entered into a RedCap data base created for the study.
24840|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
25875|NCT02305017|B3|Baseline|Total|Total of all reporting groups
24815|NCT02311972|P2|Participant Flow|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
24816|NCT02311972|P1|Participant Flow|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
24817|NCT02311972|O1|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|The nurse will insert an InnerSense temperature sensor/feeding tube per normal standards as soon after birth as possible, during delivery room stabilization. Nurses will record an axillary temperature upon admission to the NICU, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
24818|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
24819|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
24820|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
24821|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
24822|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
24823|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
24841|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
24842|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
25697|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
24824|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
24825|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
24826|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
24827|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
24828|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
24829|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
24830|NCT02311972|E2|Reported Event|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
24831|NCT02311972|E1|Reported Event|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
24832|NCT02311907|B3|Baseline|Total|Total of all reporting groups
24833|NCT02311907|B2|Baseline|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
24834|NCT02311907|B1|Baseline|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
24835|NCT02311907|P2|Participant Flow|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
24836|NCT02311907|P1|Participant Flow|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
24837|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
24838|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
24844|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
24845|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
24846|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
24847|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
24848|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
24849|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
24850|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
24851|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
24852|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
24853|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
24854|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
24855|NCT02311907|E2|Reported Event|B (Placebo, Paclitaxel)|Quality-of-Life Assessment: Ancillary studies
24856|NCT02311907|E1|Reported Event|A (Glutathione, Carboplatin)|Quality-of-Life Assessment: Ancillary studies
24857|NCT02311881|B4|Baseline|Total|Total of all reporting groups
24858|NCT02311881|B3|Baseline|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24859|NCT02311881|B2|Baseline|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24860|NCT02311881|B1|Baseline|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24861|NCT02311881|P3|Participant Flow|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24862|NCT02311881|P2|Participant Flow|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24863|NCT02311881|P1|Participant Flow|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 milligram (mg) sustained release (SR) tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 milliliter [mL]) of water/dose for 12 weeks.
24864|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24865|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24866|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24867|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24951|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
35518|NCT02204579|E1|Reported Event|NPSP795|
25117|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24868|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24869|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24870|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24871|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24872|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24873|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24874|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24875|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24876|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
24877|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
24878|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
24879|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24880|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24881|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24882|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24883|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24884|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24885|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24886|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
25116|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24887|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24888|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24889|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24890|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24891|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24892|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24893|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24894|NCT02311881|E3|Reported Event|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24895|NCT02311881|E2|Reported Event|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24896|NCT02311881|E1|Reported Event|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
24897|NCT02311309|B4|Baseline|Total|Total of all reporting groups
24898|NCT02311309|B3|Baseline|No Peroperative Significant Bleeding|Patients for whom surgery did not result in significant bleeding
24899|NCT02311309|B2|Baseline|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.
Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
24900|NCT02311309|B1|Baseline|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.
Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
24901|NCT02311309|P3|Participant Flow|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
24902|NCT02311309|P2|Participant Flow|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.
Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
24903|NCT02311309|P1|Participant Flow|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.
Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
24904|NCT02311309|O3|Outcome|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
24905|NCT02311309|O2|Outcome|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.
Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
24906|NCT02311309|O1|Outcome|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.
Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
24907|NCT02311309|O3|Outcome|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
24908|NCT02311309|O2|Outcome|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.
Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
24909|NCT02311309|O1|Outcome|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.
Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
24910|NCT02311309|E3|Reported Event|No Peroperative Significant Bleeding|Patients for whom surgery did not result in significant bleeding
35519|NCT02204449|B3|Baseline|Total|Total of all reporting groups
24911|NCT02311309|E2|Reported Event|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.
Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
24912|NCT02311309|E1|Reported Event|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.
Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
24913|NCT02310776|B1|Baseline|Automated & Handheld Beast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.
Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
24914|NCT02310776|P1|Participant Flow|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.
Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
24915|NCT02310776|O1|Outcome|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.
Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
24916|NCT02310776|E1|Reported Event|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.
Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
24917|NCT02310750|B12|Baseline|Total|Total of all reporting groups
24918|NCT02310750|B11|Baseline|PF-06700841: 100 mg Food Effect Cohort|All participants who received either PF-06700841 100 mg tablet under fasted condition or PF-06700841 100 mg tablet under fed condition or PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in any 1 of the 6 treatment sequences in food effects cohort of the study.
24919|NCT02310750|B10|Baseline|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24920|NCT02310750|B9|Baseline|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24921|NCT02310750|B8|Baseline|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24922|NCT02310750|B7|Baseline|Placebo: SAD Cohort Then MAD Cohort|Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
24923|NCT02310750|B6|Baseline|PF-­06700841: 200 mg SAD Cohort, 175 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
24924|NCT02310750|B5|Baseline|PF­-06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
24925|NCT02310750|B4|Baseline|PF-06700841: 30 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
24926|NCT02310750|B3|Baseline|PF­-06700841: 10 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
24927|NCT02310750|B2|Baseline|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24928|NCT02310750|B1|Baseline|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24929|NCT02310750|P16|Participant Flow|PF-06700841: 100 mg Tablet Fed, Tablet Fasted, Solution Fasted|Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
24952|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
27288|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
24930|NCT02310750|P15|Participant Flow|PF-06700841: 100 mg Solution Fasted, Tablet Fed, Tablet Fasted|Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
24931|NCT02310750|P14|Participant Flow|PF-06700841: 100 mg Tablet Fasted, Solution Fasted, Tablet Fed|Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
24932|NCT02310750|P13|Participant Flow|PF-06700841: 100 mg Tablet Fed, Solution Fasted, Tablet Fasted|Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
24933|NCT02310750|P12|Participant Flow|PF-06700841: 100 mg Solution Fasted, Tablet Fasted, Tablet Fed|Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
24934|NCT02310750|P11|Participant Flow|PF-06700841: 100 mg Tablet Fasted, Tablet Fed, Solution Fasted|Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by second washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
24935|NCT02310750|P10|Participant Flow|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24936|NCT02310750|P9|Participant Flow|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24937|NCT02310750|P8|Participant Flow|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24938|NCT02310750|P7|Participant Flow|Placebo: SAD Cohort Then MAD Cohort|Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
24939|NCT02310750|P6|Participant Flow|PF-­06700841: 200 mg SAD Cohort, 175 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
24940|NCT02310750|P5|Participant Flow|PF­-06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
24941|NCT02310750|P4|Participant Flow|PF-06700841: 30 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
24942|NCT02310750|P3|Participant Flow|PF­-06700841: 10 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
24943|NCT02310750|P2|Participant Flow|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24944|NCT02310750|P1|Participant Flow|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24945|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24946|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24947|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24948|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
24949|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
24950|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
24953|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
24954|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
24955|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24956|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24957|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24958|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24959|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24960|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24961|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24962|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24963|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24964|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24965|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
24966|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
24967|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
24968|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
24969|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
24970|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
24971|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
24972|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24973|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24974|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24975|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24976|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24977|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24978|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24979|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24980|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24981|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24982|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
24983|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
24984|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
24985|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
24986|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
24987|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
24988|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
24989|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24990|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24991|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24992|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24993|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24994|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24995|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
24996|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24997|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24998|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
24999|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25000|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25001|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25002|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25003|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25004|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25005|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25006|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25007|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25008|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25009|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25010|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25011|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25012|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25013|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25014|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25015|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25016|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25017|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25018|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25019|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25020|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25021|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25022|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25023|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25024|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25025|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25026|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25027|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25028|NCT02310750|O7|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25029|NCT02310750|O6|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25030|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25031|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25032|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25033|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25034|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25035|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25036|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25037|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25038|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25039|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25040|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25041|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25042|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25043|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25044|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25045|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25046|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25047|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25048|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25049|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25050|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25051|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25052|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25053|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25054|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25055|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25056|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25057|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25058|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25059|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25060|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25061|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25062|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25063|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25064|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25065|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25066|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25067|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25068|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25069|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25070|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25071|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25072|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25073|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25074|NCT02310750|O16|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
25075|NCT02310750|O15|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25076|NCT02310750|O14|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25077|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25078|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25079|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25080|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25081|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25082|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
27289|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
25083|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25084|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25085|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25086|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25087|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25088|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25089|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25090|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25091|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25092|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25093|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25094|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25095|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25096|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25097|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25098|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25099|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25100|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25101|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25102|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25103|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25104|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25105|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25106|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25107|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25108|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25109|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25110|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25111|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25112|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25113|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25114|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25115|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25698|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25118|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25119|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25120|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25121|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25122|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25123|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25124|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25125|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25126|NCT02310750|O7|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25127|NCT02310750|O6|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25128|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25129|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25130|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25131|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25132|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25133|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25134|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25135|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25136|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25137|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25138|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25139|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
25140|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25141|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25142|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25143|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25144|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25145|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25146|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25147|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25148|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25149|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25150|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25151|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25152|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25153|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25154|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25155|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25156|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25157|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25158|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25159|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25160|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25161|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25162|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25163|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25164|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25165|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25166|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25167|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25168|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
25169|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25170|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25171|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
25172|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25173|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25174|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
25175|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25176|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25177|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25178|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25179|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25180|NCT02310750|O10|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25213|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25214|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25181|NCT02310750|O9|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25182|NCT02310750|O8|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25183|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25184|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25185|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25186|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25187|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25188|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25189|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25190|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25191|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25192|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25193|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25194|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25195|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25196|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25197|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
25198|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25199|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25200|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25201|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25202|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25203|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25204|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25205|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25206|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25207|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25208|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25209|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25210|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25211|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25212|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
36427|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
25215|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25216|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25217|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
25218|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25219|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25220|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25221|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25222|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25223|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25224|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25225|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25226|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25227|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25228|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25229|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25230|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25231|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25232|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25233|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25234|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25235|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25236|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25237|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
25238|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25239|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25240|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25241|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25242|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25243|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25244|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25245|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25246|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25247|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25248|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25249|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25250|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25251|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25252|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25253|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25254|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25255|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25256|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25257|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25258|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25259|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25260|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25261|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25262|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25263|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25264|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25265|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25266|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25267|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25268|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25269|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25270|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25271|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25272|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25273|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25274|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25275|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25276|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25277|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25278|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25279|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25280|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25281|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25282|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25283|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25284|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25285|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25286|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25287|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25288|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25289|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25290|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25291|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
25292|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25293|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25294|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25295|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25296|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25297|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25298|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25299|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25300|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25301|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25302|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25303|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25304|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25305|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25306|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25307|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25308|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25309|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25310|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25344|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25311|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25312|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25313|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25314|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25315|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25316|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25317|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25318|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25319|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25320|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25321|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25322|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25323|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25324|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25325|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25326|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25327|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25328|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25329|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25330|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25331|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25332|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25333|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25334|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25335|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25336|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25337|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25338|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25339|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25340|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25341|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25342|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25343|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25345|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25346|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25347|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25348|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25349|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25350|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25351|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25352|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25353|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25354|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25355|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25356|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25357|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25358|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25359|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25360|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25361|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25362|NCT02310750|E20|Reported Event|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
25363|NCT02310750|E19|Reported Event|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25364|NCT02310750|E18|Reported Event|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
25365|NCT02310750|E17|Reported Event|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25366|NCT02310750|E16|Reported Event|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25367|NCT02310750|E15|Reported Event|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25368|NCT02310750|E14|Reported Event|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25369|NCT02310750|E13|Reported Event|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25370|NCT02310750|E12|Reported Event|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25371|NCT02310750|E11|Reported Event|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25372|NCT02310750|E10|Reported Event|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25373|NCT02310750|E9|Reported Event|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25374|NCT02310750|E8|Reported Event|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
25375|NCT02310750|E7|Reported Event|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25376|NCT02310750|E6|Reported Event|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25377|NCT02310750|E5|Reported Event|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
41619|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
25378|NCT02310750|E4|Reported Event|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
25379|NCT02310750|E3|Reported Event|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
25380|NCT02310750|E2|Reported Event|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
25381|NCT02310750|E1|Reported Event|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
25382|NCT02310646|B3|Baseline|Total|Total of all reporting groups
25383|NCT02310646|B2|Baseline|Gel - Foam|Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
25384|NCT02310646|B1|Baseline|Foam - Gel|Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
25385|NCT02310646|P2|Participant Flow|Gel - Foam|"Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week
Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
25386|NCT02310646|P1|Participant Flow|Foam - Gel|"Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week
Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
25387|NCT02310646|O8|Outcome|Prefer Gel - Not at All Important Factor|Subjects who prefer gel
25388|NCT02310646|O7|Outcome|Prefer Gel - Not Very Important Factor|Subjects who prefer gel
25389|NCT02310646|O6|Outcome|Prefer Gel - Fairly Important Factor|Subjects who prefer gel
25390|NCT02310646|O5|Outcome|Prefer Gel - Very Important Factor|Subjects who prefer gel
25391|NCT02310646|O4|Outcome|Prefer Foam - Not at All Important Factor|Subjects who prefer foam
25392|NCT02310646|O3|Outcome|Prefer Foam - Not Very Important Factor|Subjects who prefer foam
25393|NCT02310646|O2|Outcome|Prefer Foam - Fairly Important Factor|Subjects who prefer foam
25394|NCT02310646|O1|Outcome|Prefer Foam - Very Important Factor|Subjects who prefer foam
25395|NCT02310646|O2|Outcome|Daivobet® Gel|Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group.
25396|NCT02310646|O1|Outcome|LEO 90100 Areosol Foam|Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 foam assessments from the foam-gel group as well as the gel-foam group.
25397|NCT02310646|O2|Outcome|All Subjects Gel|Subject assessments of Daivobet® gel compared to latest topical treatment (CLTT analysis set).
25398|NCT02310646|O1|Outcome|All Subjects Foam|Subject assessments of LEO 90100 aerosol foam compared to latest topical treatment (CLTT analysis set).
25399|NCT02310646|O3|Outcome|Daivobet® Gel|"Subjects who had used topical treatment to treat their psoriasis within 3 months prior to baseline.
Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group."
25400|NCT02310646|O2|Outcome|LEO 90100 Aerosol Foam|"Subjects who had used topical treatment to treat their psoriasis within 3 months prior to Baseline.
Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 aerosol foam assessments from the foam-gel group as well as the gel-foam group."
25401|NCT02310646|O1|Outcome|Latest Topical Treatment|Subjects who had used topical treatment to treat their psoriasis within 3 months prior to baseline. Assessments of last topical treatment (TPUQ tool) at baseline.
25402|NCT02310646|O2|Outcome|Daivobet® Gel|Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group.
25403|NCT02310646|O1|Outcome|LEO 90100 Areosol Foam|Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 foam assessments from the foam-gel group as well as the gel-foam group.
25404|NCT02310646|O3|Outcome|Gel - Foam|Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
25405|NCT02310646|O2|Outcome|Foam - Gel|Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
25406|NCT02310646|O1|Outcome|All Randomised Subjects|All randomised subjects (foam – gel and gel – foam)
25407|NCT02310646|E2|Reported Event|Gel - Foam|"Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week
Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
25408|NCT02310646|E1|Reported Event|Foam - Gel|"Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week
Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
25409|NCT02310581|B5|Baseline|Total|Total of all reporting groups
25410|NCT02310581|B4|Baseline|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
25411|NCT02310581|B3|Baseline|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
25412|NCT02310581|B2|Baseline|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
25413|NCT02310581|B1|Baseline|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
25699|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25415|NCT02310581|P3|Participant Flow|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
25416|NCT02310581|P2|Participant Flow|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
25417|NCT02310581|P1|Participant Flow|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
25418|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
25419|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
25420|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
25421|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
25422|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
25423|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
25424|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
25425|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
25426|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
25427|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
25428|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
25429|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
25430|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
25431|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
25432|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
25433|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
25434|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
25435|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
25436|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
25437|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
25438|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
25439|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
25440|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
25441|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
25442|NCT02310581|O4|Outcome|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
25443|NCT02310581|O3|Outcome|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
25444|NCT02310581|O2|Outcome|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
25445|NCT02310581|O1|Outcome|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
25446|NCT02310581|E4|Reported Event|Placebo|Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
25447|NCT02310581|E3|Reported Event|Buprenorphine 1.0 mg TID|Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
25448|NCT02310581|E2|Reported Event|Buprenorphine 1.0 mg BID|Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
25449|NCT02310581|E1|Reported Event|Buprenorphine 0.5 mg TID|Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
25450|NCT02310568|B6|Baseline|Total|Total of all reporting groups
25484|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
39227|NCT02171195|O8|Outcome|Group 7 900 mg|BIA 2-093 900mg or placebo
25485|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
25451|NCT02310568|B5|Baseline|PF-06372865 7.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
25452|NCT02310568|B4|Baseline|PF-06372865 2.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
25453|NCT02310568|B3|Baseline|Placebo + PF-06372865 7.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
25454|NCT02310568|B2|Baseline|Placebo + PF-06372865 2.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 2.
25455|NCT02310568|B1|Baseline|Placebo + Placebo|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
25456|NCT02310568|P5|Participant Flow|PF-06372865 7.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
25457|NCT02310568|P4|Participant Flow|PF-06372865 2.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
25458|NCT02310568|P3|Participant Flow|Placebo + PF-06372865 7.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
25459|NCT02310568|P2|Participant Flow|Placebo + PF-06372865 2.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 milligram (mg) tablet twice daily for 4 weeks during Stage 2.
25460|NCT02310568|P1|Participant Flow|Placebo + Placebo|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
25461|NCT02310568|O6|Outcome|PF­06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25462|NCT02310568|O5|Outcome|PF­06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
25463|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
25464|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25465|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25466|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25467|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25468|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
25469|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
25470|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25471|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25472|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25473|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25474|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
25475|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
25476|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25477|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25478|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25479|NCT02310568|O2|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25480|NCT02310568|O1|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
25481|NCT02310568|O2|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25482|NCT02310568|O1|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25483|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25700|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25486|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25487|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25488|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25489|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25490|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
25491|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
25492|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25493|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25494|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25495|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25496|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
25497|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
25498|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25499|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25500|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25501|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25502|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25503|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25504|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25505|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
25506|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
25507|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25508|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25509|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25510|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25511|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
25512|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
25513|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25514|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25515|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25516|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25517|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
25518|NCT02310568|O1|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
25519|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25520|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
25521|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
25522|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
39228|NCT02171195|O7|Outcome|Group 6 600 mg|BIA 2-093 600mg or placebo
25523|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25524|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25525|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25526|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25527|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25528|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
25529|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
25530|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
25531|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25532|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
25533|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
25534|NCT02310568|E3|Reported Event|PF-06372865 7.5 mg|All participants received PF-06372865 7.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
25535|NCT02310568|E2|Reported Event|PF-06372865 2.5 mg|All participants received PF-06372865 2.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
25536|NCT02310568|E1|Reported Event|Placebo|All participants received placebo matched to PF-06372865 twice daily for 4 weeks in Stage 1 and Stage 2.
25537|NCT02310126|B3|Baseline|Total|Total of all reporting groups
25538|NCT02310126|B2|Baseline|Etafilcon A(Sphere) / Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
25539|NCT02310126|B1|Baseline|Etafilcon A(Multi-focal)/ Etafilcon A(Sphere)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(multi-focal) contact lens and then received the etafilcon A(sphere) contact lens.
25540|NCT02310126|P2|Participant Flow|Etafilcon A(Sphere)/Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
25541|NCT02310126|P1|Participant Flow|Etafilcon A(Multi-focal)/Etafilcon A(Sphere)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A (multi-focal) contact lens.
25542|NCT02310126|O2|Outcome|Etafilcon A (Sphere)|Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
25543|NCT02310126|O1|Outcome|Etafilcon A(Multi-focal)|Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.
25544|NCT02310126|E2|Reported Event|Etafilcon A (Sphere)|Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
25545|NCT02310126|E1|Reported Event|Etafilcon A (Multi-focal)|Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.
25546|NCT02309723|B4|Baseline|Total|Total of all reporting groups
25547|NCT02309723|B3|Baseline|No Beta Amyloid Information|Survey respondents presented scenario with no beta amyloid information.
25548|NCT02309723|B2|Baseline|Negative Beta Amyloid Findings|Survey respondents presented scenario in which beta amyloid imaging results indicated a negative finding.
25549|NCT02309723|B1|Baseline|Positive Beta Amyloid Findings|Survey respondents presented scenario in which beta amyloid imaging results indicated a positive finding.
25550|NCT02309723|P3|Participant Flow|No Beta Amyloid Information|
25551|NCT02309723|P2|Participant Flow|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.
Beta amyloid imaging"
25552|NCT02309723|P1|Participant Flow|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.
Beta amyloid imaging"
25553|NCT02309723|O3|Outcome|No Beta Amyloid Information|
25554|NCT02309723|O2|Outcome|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.
Beta amyloid imaging"
25555|NCT02309723|O1|Outcome|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.
Beta amyloid imaging"
25556|NCT02309723|O3|Outcome|No Beta Amyloid Information|
25557|NCT02309723|O2|Outcome|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.
Beta amyloid imaging"
25558|NCT02309723|O1|Outcome|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.
Beta amyloid imaging"
25559|NCT02309723|O3|Outcome|No Beta Amyloid Information|
25560|NCT02309723|O2|Outcome|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.
Beta amyloid imaging"
25561|NCT02309723|O1|Outcome|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.
Beta amyloid imaging"
25562|NCT02309723|E3|Reported Event|No Beta Amyloid Information|
25563|NCT02309723|E2|Reported Event|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.
Beta amyloid imaging"
25564|NCT02309723|E1|Reported Event|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.
Beta amyloid imaging"
25599|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25701|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
41620|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
25565|NCT02309294|B1|Baseline|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
25566|NCT02309294|P1|Participant Flow|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
25567|NCT02309294|O1|Outcome|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
25568|NCT02309294|E1|Reported Event|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
25569|NCT02309112|B4|Baseline|Total|Total of all reporting groups
25570|NCT02309112|B3|Baseline|Yoga Group C: Maximum Exposure|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
25571|NCT02309112|B2|Baseline|Yoga Group B: Medium Exposure|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
25572|NCT02309112|B1|Baseline|Yoga Group A: Minimum Exposure|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
25573|NCT02309112|P3|Participant Flow|Yoga Group C|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
25574|NCT02309112|P2|Participant Flow|Yoga Group B|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
25575|NCT02309112|P1|Participant Flow|Yoga Group A|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
25576|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
25577|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
25578|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
25579|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
25600|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25580|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
25581|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
25582|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|"Maximum Yoga Dose
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)"
25583|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
25584|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
25585|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
25586|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
25587|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
25588|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
25589|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
25590|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
25591|NCT02309112|O1|Outcome|Eligible Participants|The group of eligible participants who agreed to be randomized to ono of three yoga groups.
25592|NCT02309112|E3|Reported Event|Yoga Group C|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
25593|NCT02309112|E2|Reported Event|Yoga Group B|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
25594|NCT02309112|E1|Reported Event|Yoga Group A|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
25595|NCT02308787|B1|Baseline|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25596|NCT02308787|P1|Participant Flow|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25597|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25598|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25601|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25602|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25603|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25604|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25605|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25606|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25607|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25608|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25609|NCT02308787|E1|Reported Event|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
25610|NCT02308748|B1|Baseline|All Study Participants|Participants who were randomized to receive either dofetilide alone, dofetilide + mexiletine, dofetilide + lidocaine, moxifloxacin + diltiazem or placebo.
25611|NCT02308748|P10|Participant Flow|C-B-D-E-A|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment C (dofetilide + mexiletine) Treatment B (dofetilide + lidocaine) Treatment D (moxifloxacin + diltiazem) Treatment E (placebo) Treatment A (dofetilide)"
25612|NCT02308748|P9|Participant Flow|B-E-C-A-D|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment B (dofetilide + lidocaine) Treatment E (placebo) Treatment C (dofetilide + mexiletine) Treatment A (dofetilide) Treatment D (moxifloxacin + diltiazem)"
25613|NCT02308748|P8|Participant Flow|A-E-D-B-C|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment A (dofetilide) Treatment E (placebo) Treatment D (moxifloxacin + diltiazem) Treatment B (dofetilide + lidocaine) Treatment C (dofetilide + mexiletine)"
25614|NCT02308748|P7|Participant Flow|E-B-A-C-D|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment E (placebo) Treatment B (dofetilide + lidocaine) Treatment A (dofetilide) Treatment C (dofetilide + mexiletine) Treatment D (moxifloxacin + diltiazem)"
25615|NCT02308748|P6|Participant Flow|D-A-C-E-B|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment D (moxifloxacin + diltiazem) Treatment A (dofetilide) Treatment C (dofetilide + mexiletine) Treatment E (placebo) Treatment B (dofetilide + lidocaine)"
25616|NCT02308748|P5|Participant Flow|E-A-B-D-C|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment E (placebo) Treatment A (dofetilide) Treatment B (dofetilide + lidocaine) Treatment D (moxifloxacin + diltiazem) Treatment C (dofetilide + mexiletine)"
25617|NCT02308748|P4|Participant Flow|D-C-A-B-E|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment D (moxifloxacin + diltiazem) Treatment C (dofetilide + mexiletine) Treatment A (dofetilide) Treatment B (dofetilide + lidocaine) Treatment E (placebo)"
25618|NCT02308748|P3|Participant Flow|C-D-B-A-E|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment C (dofetilide + mexiletine) Treatment D (moxifloxacin + diltiazem) Treatment B (dofetilide + lidocaine) Treatment A (dofetilide) Treatment E (placebo)"
25619|NCT02308748|P2|Participant Flow|B-C-E-D-A|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment B (dofetilide + lidocaine) Treatment C (dofetilide + mexiletine) Treatment E (placebo) Treatment D (moxifloxacin + diltiazem) Treatment A (dofetilide)"
25620|NCT02308748|P1|Participant Flow|A-D-E-C-B|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment A (dofetilide) Treatment D (moxifloxacin + diltiazem) Treatment E (placebo) Treatment C (dofetilide + mexiletine) Treatment B (dofetilide + lidocaine)"
25621|NCT02308748|O2|Outcome|Moxifloxacin + Diltiazem|Subjects that completed placebo and moxifloxacin + diltiazem interventions
25622|NCT02308748|O1|Outcome|Moxifloxacin Alone|Subjects that completed placebo and moxifloxacin alone interventions
25623|NCT02308748|O3|Outcome|Dofetilide + Lidocaine|Subjects that completed placebo and dofetilide + lidocaine interventions
25624|NCT02308748|O2|Outcome|Dofetilide + Mexiletine|Subjects that completed placebo and dofetilide + mexiletine interventions
25625|NCT02308748|O1|Outcome|Dofetilide Alone|Subjects that completed placebo and dofetilide alone interventions
25626|NCT02308748|E5|Reported Event|Placebo|"Placebo (#2 gelcap and intravenous saline)
Placebo: Placebo (#2 Gelcap or IV saline)"
25692|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25627|NCT02308748|E4|Reported Event|Moxifloxacin + Diltiazem|"Moxifloxacin with and without diltiazem.
Moxifloxacin: • 9 am: 5.63 mg/h per kg (loading) for 1 hour and 0.26 mg/h per kg (maintenance for 30 minutes)
2 pm: 6.14 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)
7:30 pm: 2.23 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)
Diltiazem: • 7:30 pm: 330 µg/h per kg (loading) for 60 minutes and 61 µg/h per kg (maintenance) for 30 minutes"
25628|NCT02308748|E3|Reported Event|Dofetilide + Mexiletine|"Dofetilide combined with mexiletine
Dofetilide: • 8 am: Placebo
12 pm (noon): 250 µg
5:30 pm: 250 µg
Mexiletine: • 8 am: weight x 4 mg/kg
12 pm (noon): Same as at 8 am
5:30 pm: Same as at 8 am"
25629|NCT02308748|E2|Reported Event|Dofetilide + Lidocaine|"Dofetilide combined with lidocaine
Dofetilide: • 8 am: Placebo
12 pm (noon): 250 µg
5:30 pm: 250 µg
Lidocaine: • 9 am : 30 µg/min per kg (loading) for 60 minutes and 10 µg/min per kg (maintenance) for 30 minutes
2 pm: 55 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes
7:30 pm: 52 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes"
25630|NCT02308748|E1|Reported Event|Dofetilide|"Dofetilide alone arm
Dofetilide: • 8 am: Placebo
12 pm (noon): 250 µg
5:30 pm: 250 µg"
25631|NCT02308371|B3|Baseline|Total|Total of all reporting groups
25632|NCT02308371|B2|Baseline|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.
25633|NCT02308371|B1|Baseline|Prospective|"Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV> 13 (in addition to standard clinical data) until PPV < 13.
Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours."
25634|NCT02308371|P2|Participant Flow|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
25635|NCT02308371|P1|Participant Flow|Prospective|"Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5ml/kg increments for PPV> 13.
Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours."
25636|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
25637|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
25638|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
25639|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
25640|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
25641|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
25642|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.
25643|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV> 13 (in addition to standard clinical data) until PPV < 13.
25644|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
25645|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
25646|NCT02308371|E2|Reported Event|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
25693|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
39229|NCT02171195|O6|Outcome|Group 5 400 mg|BIA 2-093 or 400mg or placebo
25647|NCT02308371|E1|Reported Event|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
25648|NCT02308124|B4|Baseline|Total|Total of all reporting groups
25649|NCT02308124|B3|Baseline|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
25650|NCT02308124|B2|Baseline|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
25651|NCT02308124|B1|Baseline|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
25652|NCT02308124|P3|Participant Flow|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
25653|NCT02308124|P2|Participant Flow|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
25654|NCT02308124|P1|Participant Flow|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
25655|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
25656|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
25657|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
25658|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
25659|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
25660|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
25661|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
25662|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
25663|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
25664|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
25665|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
25666|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
25667|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
25668|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
25669|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
25670|NCT02308124|E3|Reported Event|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
25671|NCT02308124|E2|Reported Event|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
25672|NCT02308124|E1|Reported Event|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
25673|NCT02307838|B4|Baseline|Total|Total of all reporting groups
25674|NCT02307838|B3|Baseline|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
25675|NCT02307838|B2|Baseline|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25676|NCT02307838|B1|Baseline|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25677|NCT02307838|P3|Participant Flow|Placebo|In FTY720D2201, participants received matching placebo to FTY720 q.d. for 6 months.
25678|NCT02307838|P2|Participant Flow|FTY720 1.25 mg|In FTY720D2201, participants received FTY720 1.25 mg q.d. oral dose for 6 months.
25679|NCT02307838|P1|Participant Flow|FTY720 5.0 mg|In FTY720D2201, participants received FTY720 5.0 mg every day (q.d.) oral dose for 6 months.
25680|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25681|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25682|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25683|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25684|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25685|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25686|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25687|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25688|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25689|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25690|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25691|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25702|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25703|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25704|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
25705|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
25706|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25707|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
25708|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
25709|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25710|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
25711|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
25712|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25713|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
25714|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
25715|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25716|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
25717|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25718|NCT02307838|E3|Reported Event|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
25719|NCT02307838|E2|Reported Event|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy disease modifying therapies (DMTs) for at least 2 years.
25720|NCT02307838|E1|Reported Event|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
25721|NCT02307552|B1|Baseline|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.
UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
25722|NCT02307552|P1|Participant Flow|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.
UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
25723|NCT02307552|O1|Outcome|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.
UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
25750|NCT02307266|O2|Outcome|Standard of Care|Subjects received standard-of-care instructions only.
25751|NCT02307266|O1|Outcome|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
25752|NCT02307266|E3|Reported Event|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
25753|NCT02307266|E2|Reported Event|Standard of Care|Subjects received standard-of-care instructions only.
25724|NCT02307552|E1|Reported Event|All Patients|"All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.
UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection."
25725|NCT02307526|B1|Baseline|Spinal Cord Injury|Ten individuals with SCI (C4-C7) were recruited.
25726|NCT02307526|P1|Participant Flow|Spinal Cord Injury|10 individuals with spinal cord injury (SCI: C4-C7) were recruited.
25727|NCT02307526|O2|Outcome|NO Drug|Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
25728|NCT02307526|O1|Outcome|Pyridostigmine Bromide|After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
25729|NCT02307526|O2|Outcome|NO Drug|Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
25730|NCT02307526|O1|Outcome|Pyridostigmine Bromide|After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
25731|NCT02307526|O2|Outcome|NO Drug|Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
25732|NCT02307526|O1|Outcome|Pyridostigmine Bromide|After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
25733|NCT02307526|E2|Reported Event|Day 2 - Pyridostigmine Bromide|After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide 60 mg will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
25734|NCT02307526|E1|Reported Event|Day 1 - No Drug|Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
25735|NCT02307318|B1|Baseline|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
25736|NCT02307318|P1|Participant Flow|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
25737|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
25738|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
25739|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
25740|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
25741|NCT02307318|E1|Reported Event|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
25742|NCT02307266|B4|Baseline|Total|Total of all reporting groups
25743|NCT02307266|B3|Baseline|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
25744|NCT02307266|B2|Baseline|Standard of Care|Subjects received standard-of-care instructions only.
25745|NCT02307266|B1|Baseline|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
25746|NCT02307266|P3|Participant Flow|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
25747|NCT02307266|P2|Participant Flow|Standard of Care|Subjects received standard-of-care instructions only.
25748|NCT02307266|P1|Participant Flow|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
25749|NCT02307266|O3|Outcome|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
25813|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
25754|NCT02307266|E1|Reported Event|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
25755|NCT02307188|B1|Baseline|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.
Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter."
25756|NCT02307188|P1|Participant Flow|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.
Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.
Since enrollment began, a total of five (5) patients consented to enrollment in the study during their atrial fibrillation/tachycardia ablation procedures. The catheter (a new catheter was used for each patient) was used in the left atrium in one patient who met all inclusion criteria and did not have any exclusions."
25757|NCT02307188|O1|Outcome|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.
Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.
Five (5) patients were enrolled. The catheters were used in the left atrium in one (1) patient. The remaining patients were excluded because of subtherapeutic ACT levels < 300 seconds (3 patients) or presence of prosthetic valve (1 patient).
Due to the paucity of information collected from the one patient for whom the catheter was used in the left atrium, the collected electrogram data were not analyzed further."
25758|NCT02307188|E1|Reported Event|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.
Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.
No adverse events related to this catheter were noted."
25759|NCT02307123|B1|Baseline|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.
Intubation: HEMS physician prehospital intubation"
25760|NCT02307123|P1|Participant Flow|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.
Intubation: HEMS physician prehospital intubation"
25761|NCT02307123|O1|Outcome|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.
Intubation: HEMS physician prehospital intubation"
25762|NCT02307123|O1|Outcome|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.
Intubation: HEMS physician prehospital intubation"
25763|NCT02307123|E1|Reported Event|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.
Intubation: HEMS physician prehospital intubation"
25764|NCT02306928|B1|Baseline|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
25765|NCT02306928|P1|Participant Flow|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
25766|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
25767|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
25768|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
25814|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
25815|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
25816|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
25817|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
25818|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
25819|NCT02305329|E4|Reported Event|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
25820|NCT02305329|E3|Reported Event|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
27296|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
25769|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
25770|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
25771|NCT02306928|E1|Reported Event|Piperacillin Pharmacokinetics|Serious and non-serious adverse advents were not collected.
25772|NCT02306759|B3|Baseline|Total|Total of all reporting groups
25773|NCT02306759|B2|Baseline|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes"
25774|NCT02306759|B1|Baseline|Treatment|"Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
25775|NCT02306759|P2|Participant Flow|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes"
25776|NCT02306759|P1|Participant Flow|Treatment|"Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
25777|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
25778|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
25779|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
25780|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
25781|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
25782|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
25783|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
25784|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
25785|NCT02306759|O2|Outcome|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
Placebo: Normal saline 50ml, administered over 15 minutes"
25786|NCT02306759|O1|Outcome|Treatment|"Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes
Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
25787|NCT02306759|E2|Reported Event|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
25788|NCT02306759|E1|Reported Event|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
25789|NCT02305446|B1|Baseline|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
25790|NCT02305446|P1|Participant Flow|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
25791|NCT02305446|O1|Outcome|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
25792|NCT02305446|O1|Outcome|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
25793|NCT02305446|E1|Reported Event|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
25794|NCT02305329|B5|Baseline|Total|Total of all reporting groups
25795|NCT02305329|B4|Baseline|Group 2 BIA 9-1067 50 mg|"Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC
BIA 9-1067"
25796|NCT02305329|B3|Baseline|Group 1 BIA 9-1067 50 mg|"Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC
BIA 9-1067"
25797|NCT02305329|B2|Baseline|Group 2 BIA 9-1067 25 mg|"Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC
BIA 9-1067"
25798|NCT02305329|B1|Baseline|Group 1 BIA 9-1067 25 mg|"Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC
BIA 9-1067"
25799|NCT02305329|P4|Participant Flow|Group 2 BIA 9-1067 50 mg|"Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC
BIA 9-1067"
25800|NCT02305329|P3|Participant Flow|Group 1 BIA 9-1067 50 mg|"Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC
BIA 9-1067"
25801|NCT02305329|P2|Participant Flow|Group 2 BIA 9-1067 25 mg|"Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC
BIA 9-1067"
25802|NCT02305329|P1|Participant Flow|Group 1 BIA 9-1067 25 mg|"Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC
BIA 9-1067"
25803|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
25804|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
25805|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
25806|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
25807|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
25808|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
25809|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
25810|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
25811|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
25812|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
25824|NCT02305316|B2|Baseline|BIA 9-1067 Micronized - Non-micronized|"Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized
BIA 9-1067 non-micronized
BIA 9-1067 micronized"
25825|NCT02305316|B1|Baseline|BIA 9-1067 Non-micronized - Micronized|"Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized
BIA 9-1067 non-micronized
BIA 9-1067 micronized"
25826|NCT02305316|P2|Participant Flow|BIA 9-1067 Micronized - Non-micronized|"Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized
BIA 9-1067 non-micronized
BIA 9-1067 micronized"
25827|NCT02305316|P1|Participant Flow|BIA 9-1067 Non-micronized - Micronized|"Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized
BIA 9-1067 non-micronized
BIA 9-1067 micronized"
25828|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
25829|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
25830|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
25831|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
25832|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
25833|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
25834|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
25835|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
25836|NCT02305316|E2|Reported Event|BIA 9-1067 Micronized|BIA 9-1067 micronized.
25837|NCT02305316|E1|Reported Event|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
25838|NCT02305277|B7|Baseline|Total|Total of all reporting groups
25839|NCT02305277|B6|Baseline|BIA 9-1067 50 mg Sequence 2|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25840|NCT02305277|B5|Baseline|BIA 9-1067 25 mg Sequence 2|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25841|NCT02305277|B4|Baseline|BIA 9-1067 5 mg Sequence 2|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25842|NCT02305277|B3|Baseline|BIA 9-1067 50 mg Sequence 1|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25843|NCT02305277|B2|Baseline|BIA 9-1067 25 mg Sequence 1|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25844|NCT02305277|B1|Baseline|BIA 9-1067 5 mg Sequence 1|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25845|NCT02305277|P6|Participant Flow|BIA 9-1067 50 mg Sequence 2|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25846|NCT02305277|P5|Participant Flow|BIA 9-1067 25 mg Sequence 2|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25847|NCT02305277|P4|Participant Flow|BIA 9-1067 5 mg Sequence 2|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25848|NCT02305277|P3|Participant Flow|BIA 9-1067 50 mg Sequence 1|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25849|NCT02305277|P2|Participant Flow|BIA 9-1067 25 mg Sequence 1|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25850|NCT02305277|P1|Participant Flow|BIA 9-1067 5 mg Sequence 1|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)"
25851|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
25852|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
25853|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
25854|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
25855|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
25856|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
25857|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
25858|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
25859|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
25860|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
25861|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
25862|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
25863|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
25864|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
25876|NCT02305017|B2|Baseline|Period 1 OPC; Period 2 OPC+ Paracetamol|"Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;
BIA 9-1067: BIA 9-1067 50 mg
Paracetamol: Paracetamol 1g"
25877|NCT02305017|B1|Baseline|Period 1 OPC + Paracetamol; Period 2 OPC|"Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)
BIA 9-1067: BIA 9-1067 50 mg
Paracetamol: Paracetamol 1g"
25878|NCT02305017|P2|Participant Flow|Period 1 OPC; Period 2 OPC+ Paracetamol|"Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;
BIA 9-1067: BIA 9-1067 50 mg
Paracetamol: Paracetamol 1g"
25879|NCT02305017|P1|Participant Flow|Period 1 OPC + Paracetamol; Period 2 OPC|"Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)
BIA 9-1067: BIA 9-1067 50 mg
Paracetamol: Paracetamol 1g"
25880|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1067 50 mg Paracetamol, acetominophen, 1 g
25881|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1067 50 mg
25882|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1067 50 mg Paracetamol, acetominophen, 1 g
25883|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1067 50 mg
25884|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol, acetominphen
25885|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1079
25886|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
25887|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1079 alone
25888|NCT02305017|E2|Reported Event|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
25889|NCT02305017|E1|Reported Event|Opicapone Alone|Opicapone, OPC, BIA 9-1079 alone
25890|NCT02304926|B3|Baseline|Total|Total of all reporting groups
25891|NCT02304926|B2|Baseline|Ezetimibe|"20 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25892|NCT02304926|B1|Baseline|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25893|NCT02304926|P2|Participant Flow|Ezetimibe|"20 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25894|NCT02304926|P1|Participant Flow|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25895|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25896|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25897|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25898|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25899|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25900|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25901|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25902|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25903|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25904|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25905|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25906|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25907|NCT02304926|O2|Outcome|Ezetimibe|"19 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25908|NCT02304926|O1|Outcome|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25909|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25910|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25911|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25912|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25913|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25914|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
26106|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
25915|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25916|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25917|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25918|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25919|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25920|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25921|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25922|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25923|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25924|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25925|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25926|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25927|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25928|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
26107|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
25929|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25930|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25931|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25932|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25933|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25934|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25935|NCT02304926|E2|Reported Event|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe: ezetimibe (10 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25936|NCT02304926|E1|Reported Event|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Simvastatin: simvastatin (40 mg/day) for 4 weeks
Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
25937|NCT02303743|B3|Baseline|Total|Total of all reporting groups
25938|NCT02303743|B2|Baseline|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution
Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
25939|NCT02303743|B1|Baseline|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.
Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
25940|NCT02303743|P2|Participant Flow|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution
Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
25941|NCT02303743|P1|Participant Flow|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.
Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
25942|NCT02303743|O2|Outcome|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution
Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
25971|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25972|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25973|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25943|NCT02303743|O1|Outcome|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.
Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
25944|NCT02303743|O2|Outcome|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution
Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
25945|NCT02303743|O1|Outcome|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.
Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
25946|NCT02303743|E2|Reported Event|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution
Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
25947|NCT02303743|E1|Reported Event|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.
Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
25948|NCT02303704|B3|Baseline|Total|Total of all reporting groups
25949|NCT02303704|B2|Baseline|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
25950|NCT02303704|B1|Baseline|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts
25951|NCT02303704|P2|Participant Flow|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
25952|NCT02303704|P1|Participant Flow|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
25953|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
25954|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
25955|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
25956|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
25957|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
25958|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
25959|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
25960|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
25961|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
25962|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
25963|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
25964|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
25965|NCT02303704|E2|Reported Event|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
25966|NCT02303704|E1|Reported Event|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
25967|NCT02302365|B1|Baseline|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25968|NCT02302365|P1|Participant Flow|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25969|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25970|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
39230|NCT02171195|O5|Outcome|Group 4 200 mg|BIA 2-093 200mg or placebo
25974|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25975|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25976|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25977|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25978|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25979|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25980|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25981|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25982|NCT02302365|E1|Reported Event|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
25983|NCT02301975|B4|Baseline|Total|Total of all reporting groups
25984|NCT02301975|B3|Baseline|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25985|NCT02301975|B2|Baseline|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25986|NCT02301975|B1|Baseline|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25987|NCT02301975|P3|Participant Flow|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25988|NCT02301975|P2|Participant Flow|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25989|NCT02301975|P1|Participant Flow|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25990|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25991|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25992|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25993|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25994|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25995|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25996|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25997|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25998|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
25999|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26000|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26001|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
27290|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
26002|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26003|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26004|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26005|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26006|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26007|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26008|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26009|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26010|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26011|NCT02301975|E3|Reported Event|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26012|NCT02301975|E2|Reported Event|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26013|NCT02301975|E1|Reported Event|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
26014|NCT02301936|B3|Baseline|Total|Total of all reporting groups
26015|NCT02301936|B2|Baseline|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
26016|NCT02301936|B1|Baseline|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
26017|NCT02301936|P2|Participant Flow|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
26018|NCT02301936|P1|Participant Flow|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) 90/400 mg fixed dose combination (FDC) tablet once daily for 12 weeks
26019|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
26020|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
26021|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
26022|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
26023|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
26024|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
26025|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
26026|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
26027|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
26028|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
26029|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
26030|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
26031|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
26032|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
26033|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
26104|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
26034|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
26035|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
26036|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
26037|NCT02301936|E2|Reported Event|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
26038|NCT02301936|E1|Reported Event|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
26039|NCT02301429|B1|Baseline|Model 20105|"Receiving the model 20105 Lead
Model 20105: implant and follow-up of study device"
26040|NCT02301429|P1|Participant Flow|Model 20105|"Receiving the model 20105 Lead
Model 20105: implant and follow-up of study device"
26041|NCT02301429|O1|Outcome|Model 20105|"Receiving the model 20105 Lead
Model 20105: implant and follow-up of study device"
26042|NCT02301429|E1|Reported Event|Model 20105|"Receiving the model 20105 Lead
Model 20105: implant and follow-up of study device"
26043|NCT02301377|B3|Baseline|Total|Total of all reporting groups
26044|NCT02301377|B2|Baseline|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
26045|NCT02301377|B1|Baseline|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
26046|NCT02301377|P2|Participant Flow|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
26047|NCT02301377|P1|Participant Flow|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
26048|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
26049|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
26050|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
26051|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
26052|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
26053|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
26054|NCT02301377|E2|Reported Event|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
26055|NCT02301377|E1|Reported Event|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
26056|NCT02301169|B3|Baseline|Total|Total of all reporting groups
26057|NCT02301169|B2|Baseline|Placebo|"Heat pain stimuli B
Video B
Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
26058|NCT02301169|B1|Baseline|T4P1001|"Heat pain stimuli A
Video A
Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
26059|NCT02301169|P2|Participant Flow|Placebo|"Heat pain stimuli B
Video B
Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
26060|NCT02301169|P1|Participant Flow|T4P1001|"Heat pain stimuli A
Video A
Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
26061|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B
Video B
Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
26062|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A
Video A
Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
26063|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B
Video B
Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
26064|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A
Video A
Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
26065|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B
Video B
Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
26066|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A
Video A
Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
26067|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B
Video B
Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
26068|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A
Video A
Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
26069|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B
Video B
Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
26070|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A
Video A
Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
26071|NCT02301169|E2|Reported Event|Placebo|"Heat pain stimuli B
Video B
Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
26072|NCT02301169|E1|Reported Event|T4P1001|"Heat pain stimuli A
Video A
Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
26073|NCT02300311|B3|Baseline|Total|Total of all reporting groups
26074|NCT02300311|B2|Baseline|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.
Treatment duration consists of up to 4 days."
26075|NCT02300311|B1|Baseline|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
26076|NCT02300311|P2|Participant Flow|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.
Treatment duration consists of up to 4 days."
26077|NCT02300311|P1|Participant Flow|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
26078|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.
Treatment duration consists of up to 4 days."
26105|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
27291|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
26079|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
26080|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.
Treatment duration consists of up to 4 days."
26081|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
26082|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.
Treatment duration consists of up to 4 days."
26083|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
26084|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.
Treatment duration consists of up to 4 days."
26085|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
26086|NCT02300311|E2|Reported Event|Finalgon® Cream (Nicoboxil/ Nonivamide)|Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
26087|NCT02300311|E1|Reported Event|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
26088|NCT02300129|B1|Baseline|All Study Participants (Intent To Treat Population)|One subject was excluded from Intent to Treat (ITT) population because he didn't perform any efficacy assessment during the study so N=33 instead of 34 subjects
26089|NCT02300129|P4|Participant Flow|Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47|"Period 1:
Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks."
26090|NCT02300129|P3|Participant Flow|CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47|"Period 1:
Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks."
26091|NCT02300129|P2|Participant Flow|Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo|"Period 1:
Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks."
26092|NCT02300129|P1|Participant Flow|CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo|"Period 1:
Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks."
26093|NCT02300129|O2|Outcome|Period 2 Placebo Gel Cross-over|CD07805/47 placebo gel
26094|NCT02300129|O1|Outcome|Period 2 CD07805/47 0.5% Gel Cross-over|CD07805/47 0.5% gel (Brimonidine tartrate)
26095|NCT02300129|E6|Reported Event|Period 2 Placebo Gel Cross Over|Period 2 Placebo gel cross over (application on full face) Overall safety population, N=31
26096|NCT02300129|E5|Reported Event|Period 2 CD07805/47 0.5% Gel Cross Over|Period 2 CD07805/47 0.5% gel (application on full face) Overall safety population, N=32
26097|NCT02300129|E4|Reported Event|Period 1 CD07805/47 0.5% Gel Cross-over|Period 1 CD07805/47 0.5% cross over (application on full face) Overall safety population, N=33
26098|NCT02300129|E3|Reported Event|Period 1 Placebo Gel Split Face|Period 1 Placebo gel split face (application on one side of face) Overall safety population, N=33
26099|NCT02300129|E2|Reported Event|Period 1 CD07805/47 0.5% Gel Split Face|Period 1 CD07805/47 0.5% gel split face (application on one side of face) Overall safety population, N=33
26100|NCT02300129|E1|Reported Event|Period 1 Placebo Gel Cross Over|Period 1 Placebo gel cross over (application on full face) Overall safety population, N=34
26101|NCT02300103|B1|Baseline|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
26102|NCT02300103|P1|Participant Flow|SOF/VEL+RBV|Sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) (400/100mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 mg or 1200 mg) for 24 weeks
26103|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
26108|NCT02300103|O1|Outcome|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
26109|NCT02300103|E1|Reported Event|SOF/VEL+RBV|SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
26110|NCT02300025|B5|Baseline|Total|Total of all reporting groups
26111|NCT02300025|B4|Baseline|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class c, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26112|NCT02300025|B3|Baseline|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26113|NCT02300025|B2|Baseline|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26114|NCT02300025|B1|Baseline|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26115|NCT02300025|P4|Participant Flow|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26116|NCT02300025|P3|Participant Flow|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26117|NCT02300025|P2|Participant Flow|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26118|NCT02300025|P1|Participant Flow|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 milligrams (mg) cobimetinib (two 5 mg capsules) on Day 1 of study.
26119|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26120|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26121|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26122|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26123|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26124|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26125|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26126|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26127|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26128|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26129|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26130|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26131|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26132|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26133|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26134|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26135|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26136|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26137|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26138|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26139|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26140|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26141|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26142|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26143|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26144|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26145|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26146|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26147|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26148|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26149|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26150|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26151|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26152|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26153|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26154|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26155|NCT02300025|E4|Reported Event|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class A, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26156|NCT02300025|E3|Reported Event|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26157|NCT02300025|E2|Reported Event|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26158|NCT02300025|E1|Reported Event|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
26159|NCT02299869|B5|Baseline|Total|Total of all reporting groups
26160|NCT02299869|B4|Baseline|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26161|NCT02299869|B3|Baseline|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26162|NCT02299869|B2|Baseline|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26163|NCT02299869|B1|Baseline|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26164|NCT02299869|P4|Participant Flow|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26165|NCT02299869|P3|Participant Flow|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26166|NCT02299869|P2|Participant Flow|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26167|NCT02299869|P1|Participant Flow|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26168|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26169|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26170|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26171|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26172|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26173|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26174|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26175|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26176|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26177|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26178|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26179|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26180|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26181|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26182|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26183|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26184|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26185|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26186|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26187|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
26188|NCT02299869|E1|Reported Event|Overall Participants|Each subject was randomized to wear the test and control lenses in a series of four short fitting comparisons (pair 1, pair 2, pair 3, and pair 4).
26189|NCT02299635|B1|Baseline|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26190|NCT02299635|P1|Participant Flow|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26191|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26192|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26193|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26194|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26195|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26196|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26197|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26198|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26199|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26200|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26201|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26202|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26203|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26204|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26205|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26206|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26207|NCT02299635|E1|Reported Event|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
26208|NCT02299427|B3|Baseline|Total|Total of all reporting groups
26209|NCT02299427|B2|Baseline|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety
transportation safety: use of transportation safety website at home for about 2 weeks"
26210|NCT02299427|B1|Baseline|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research
dog safety: use of dog safety website at home for about 2 weeks"
26211|NCT02299427|P2|Participant Flow|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety
transportation safety: use of transportation safety website at home for about 2 weeks"
26212|NCT02299427|P1|Participant Flow|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research
dog safety: use of dog safety website at home for about 2 weeks"
26213|NCT02299427|O2|Outcome|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety
transportation safety: use of transportation safety website at home for about 2 weeks"
26214|NCT02299427|O1|Outcome|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research
dog safety: use of dog safety website at home for about 2 weeks"
26215|NCT02299427|O2|Outcome|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety
transportation safety: use of transportation safety website at home for about 2 weeks"
26216|NCT02299427|O1|Outcome|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research
dog safety: use of dog safety website at home for about 2 weeks"
26217|NCT02299427|E2|Reported Event|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety
transportation safety: use of transportation safety website at home for about 2 weeks"
26218|NCT02299427|E1|Reported Event|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research
dog safety: use of dog safety website at home for about 2 weeks
There is a discrepancy in participants at risk compared to the participant flow module because some children were not compliant to the intervention. They did not use the internet website and therefore were excluded from analyses. They did not have adverse events; they merely were not exposed to the intervention and therefore were excluded from analysis."
26219|NCT02299349|B3|Baseline|Total|Total of all reporting groups
26220|NCT02299349|B2|Baseline|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection
concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
26221|NCT02299349|B1|Baseline|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection
bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
26222|NCT02299349|P2|Participant Flow|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection
concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
26223|NCT02299349|P1|Participant Flow|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection
bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
26224|NCT02299349|O2|Outcome|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection
concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
26225|NCT02299349|O1|Outcome|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection
bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
26226|NCT02299349|O2|Outcome|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection
concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
26227|NCT02299349|O1|Outcome|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection
bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
26228|NCT02299349|E2|Reported Event|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection
concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
26229|NCT02299349|E1|Reported Event|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection
bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
26230|NCT02299258|B3|Baseline|Total|Total of all reporting groups
26231|NCT02299258|B2|Baseline|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
26252|NCT02298868|E1|Reported Event|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26232|NCT02299258|B1|Baseline|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.
Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
26233|NCT02299258|P2|Participant Flow|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
26234|NCT02299258|P1|Participant Flow|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.
Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
26235|NCT02299258|O2|Outcome|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
26236|NCT02299258|O1|Outcome|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.
Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
26237|NCT02299258|O2|Outcome|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
26238|NCT02299258|O1|Outcome|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.
Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
26239|NCT02299258|E2|Reported Event|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
26240|NCT02299258|E1|Reported Event|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.
Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
26241|NCT02298868|B1|Baseline|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26242|NCT02298868|P1|Participant Flow|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26243|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26244|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26245|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26246|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26247|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26248|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26249|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26250|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26251|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
26254|NCT02298842|B2|Baseline|Plasma First, Then InterSol|Platelets collected in plasma, then platelets collected in InterSol
26255|NCT02298842|B1|Baseline|InterSol First, Then Plasma|Platelets collected in InterSol, then platelets collected in plasma
26256|NCT02298842|P2|Participant Flow|Plasma First, Then InterSol|Platelets collected in plasma, then platelets collected in InterSol
26257|NCT02298842|P1|Participant Flow|InterSol First, Then Plasma|Platelets collected in InterSol, then platelets collected in plasma
26258|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26259|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26260|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26261|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26262|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26263|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26264|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26265|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26329|NCT02296931|O1|Outcome|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.
Saline: Standard IV Saline Fluids"
26330|NCT02296931|E2|Reported Event|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.
Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
26266|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26267|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26268|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26269|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26270|NCT02298842|O2|Outcome|Arm B - Platelets Stored in Plasma|"Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26271|NCT02298842|O1|Outcome|Arm A - Test Platelets Stored in InterSol|"Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26272|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26273|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26274|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26331|NCT02296931|E1|Reported Event|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.
Saline: Standard IV Saline Fluids"
26451|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26275|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26276|NCT02298842|O2|Outcome|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26277|NCT02298842|O1|Outcome|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26278|NCT02298842|E2|Reported Event|Control Platelets Collected and Stored in Plasma|"Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26279|NCT02298842|E1|Reported Event|Test Platelets Collected and Stored in InterSol|"Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other."
26280|NCT02298361|B4|Baseline|Total|Total of all reporting groups
26281|NCT02298361|B3|Baseline|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
26282|NCT02298361|B2|Baseline|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
26283|NCT02298361|B1|Baseline|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
26284|NCT02298361|P3|Participant Flow|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
26285|NCT02298361|P2|Participant Flow|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
26286|NCT02298361|P1|Participant Flow|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
26287|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
26288|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
26289|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
26290|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
26291|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
26292|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
26293|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
26294|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
26295|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
26296|NCT02298361|E3|Reported Event|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
26297|NCT02298361|E2|Reported Event|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
26298|NCT02298361|E1|Reported Event|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
26300|NCT02298192|B2|Baseline|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
26301|NCT02298192|B1|Baseline|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
26302|NCT02298192|P2|Participant Flow|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
26303|NCT02298192|P1|Participant Flow|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
26304|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
26305|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
26306|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
26307|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
26308|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
26359|NCT02295644|E2|Reported Event|B(0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26511|NCT02294604|P3|Participant Flow|Group C|"Traditional scrub formation with 4% chlorhexidine
chlorhexidine"
26309|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
26310|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
26311|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
26312|NCT02298192|E2|Reported Event|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
26313|NCT02298192|E1|Reported Event|IDegLira (1WT)|Subjects received IDegLira once weekly in combination with metformin alone or in combination with pioglitazone in a 1:1 manner at visit 2 and were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), and the maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).The daily dose for metformin (≥1500 mg or max tolerated dose) and pioglitazone (≥30 mg) The dose of IDegLira was to be adjusted once weekly based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on the titration day. The first dose of trial product was to be administered either on the day of randomisation (visit 2) or the day after.
26314|NCT02297841|B1|Baseline|HRIPT|Novel lubricant Miami w/ fragrance Novel lubricant Miami w/o fragrance 510(k) cleared and currently marketed personal lubricant 510(k) cleared and currently marketed personal lubricant
26315|NCT02297841|P1|Participant Flow|Human Repeat Insult Patch Test|"Experimental: Human Repeat Insult Patch Test
Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back."
26316|NCT02297841|O1|Outcome|Human Repeat Insult Patch Test|"Experimental: Human Repeat Insult Patch Test
Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back."
26317|NCT02297841|E1|Reported Event|HRIPT|Experimental: Novel lubricant Miami w/ frag Experimental: Novel Miami w/o frag KY Liquid lubricant Astroglide Gel lubricant
26318|NCT02297308|B1|Baseline|SoloPath Sheath|The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access
26319|NCT02297308|P1|Participant Flow|SoloPath Sheath|The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access.
26320|NCT02297308|O1|Outcome|SoloPath Sheath|Rate of VARC-2 defined access site bleeding complications.
26321|NCT02297308|O1|Outcome|SoloPath Sheath|Vascular Complications
26322|NCT02297308|E1|Reported Event|SoloPath Sheath|The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access.
26323|NCT02296931|B3|Baseline|Total|Total of all reporting groups
26324|NCT02296931|B2|Baseline|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.
Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
26325|NCT02296931|B1|Baseline|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.
Saline: Standard IV Saline Fluids"
26326|NCT02296931|P2|Participant Flow|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.
Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
26327|NCT02296931|P1|Participant Flow|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.
Saline: Standard IV Saline Fluids"
26328|NCT02296931|O2|Outcome|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.
Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
26512|NCT02294604|P2|Participant Flow|Group I|"Traditional scrub formation with 10 % povidone-iodine
povidone-iodine"
26332|NCT02295774|B1|Baseline|Group A|"Biopsy samples collected during standard white light colonoscopy.
standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy
No study drug was taken prior to initial Colonoscopy (White light only)
Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.
Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
26333|NCT02295774|P1|Participant Flow|Group A|"Biopsy samples collected during standard white light colonoscopy.
standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy
Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to initial colonoscopy the subjects take Methylene Blue MMX tablets.
Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.
Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
26334|NCT02295774|O1|Outcome|Group A|"This is a crossover study. Biopsy samples collected during standard white light colonoscopy.
standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy
Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets.
Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.
Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
26335|NCT02295774|E1|Reported Event|Group A|"This is a crossover study.
Biopsy samples collected during standard white light colonoscopy.
standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy
No study drug was taken prior to initial Colonoscopy (White light only)
Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks.
Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.
Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
26336|NCT02295644|B5|Baseline|Total|Total of all reporting groups
26337|NCT02295644|B4|Baseline|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26338|NCT02295644|B3|Baseline|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26339|NCT02295644|B2|Baseline|B(0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26340|NCT02295644|B1|Baseline|A(0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26341|NCT02295644|P4|Participant Flow|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26342|NCT02295644|P3|Participant Flow|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26343|NCT02295644|P2|Participant Flow|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26344|NCT02295644|P1|Participant Flow|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26345|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26346|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26347|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26348|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26349|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26350|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26351|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26352|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26353|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26354|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26355|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26356|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26357|NCT02295644|E4|Reported Event|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26358|NCT02295644|E3|Reported Event|C(0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26360|NCT02295644|E1|Reported Event|A(0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
26361|NCT02295020|B3|Baseline|Total|Total of all reporting groups
26362|NCT02295020|B2|Baseline|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
26363|NCT02295020|B1|Baseline|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
26364|NCT02295020|P2|Participant Flow|Standard Treatment Plus Bioskin Ten-7.|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.
Standard treatment: Standard treatment such as NSAIDs and injections
Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
26365|NCT02295020|P1|Participant Flow|Standard Treatment Only.|"Group A will receive standard treatment only
Standard treatment: Standard treatment such as NSAIDs and injections"
26366|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.
Standard treatment: Standard treatment such as NSAIDs and injections
Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
26367|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only
Standard treatment: Standard treatment such as NSAIDs and injections"
26368|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.
Standard treatment: Standard treatment such as NSAIDs and injections
Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
26369|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only
Standard treatment: Standard treatment such as NSAIDs and injections"
26370|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.
Standard treatment: Standard treatment such as NSAIDs and injections
Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
26371|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only
Standard treatment: Standard treatment such as NSAIDs and injections"
26372|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
26373|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
26374|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
26375|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
26376|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
26377|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
26378|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus knee Bioskin Ten-7 knee brace
26379|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
26380|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
26381|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections.
26382|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
26383|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
26384|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
26385|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
26386|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
26387|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
26388|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
26389|NCT02295020|O1|Outcome|Standard Treatment Only.|Standard treatment only such as NSAIDs and injections.
26390|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
26391|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections.
26392|NCT02295020|E2|Reported Event|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.
Standard treatment: Standard treatment such as NSAIDs and injections
Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
26393|NCT02295020|E1|Reported Event|Group A|"Group A will receive standard treatment only
Standard treatment: Standard treatment such as NSAIDs and injections"
26394|NCT02294773|B3|Baseline|Total|Total of all reporting groups
26395|NCT02294773|B2|Baseline|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26396|NCT02294773|B1|Baseline|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26448|NCT02294734|O2|Outcome|GSK2269557 1000 µg|Participants received 1000 µg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26397|NCT02294773|P2|Participant Flow|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26398|NCT02294773|P1|Participant Flow|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26399|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26400|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26401|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26402|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26403|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26404|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26405|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26406|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26407|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26408|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26409|NCT02294773|E2|Reported Event|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26449|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26450|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
27292|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
26410|NCT02294773|E1|Reported Event|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.
Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.
Letrozole: Patient is to take letrozole during cycle days 3-7."
26411|NCT02294734|B3|Baseline|Total|Total of all reporting groups
26412|NCT02294734|B2|Baseline|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26413|NCT02294734|B1|Baseline|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26414|NCT02294734|P2|Participant Flow|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26415|NCT02294734|P1|Participant Flow|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26416|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26417|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26418|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26419|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26420|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26421|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26422|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26423|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26424|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26425|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26426|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26427|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26428|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26429|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26430|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26431|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26432|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26433|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26434|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26435|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26436|NCT02294734|O1|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26437|NCT02294734|O1|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26438|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26439|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26440|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26441|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26442|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26443|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26444|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26445|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26446|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26447|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26452|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26453|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26454|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26455|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26456|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26457|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26458|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26459|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26460|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26461|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26462|NCT02294734|E2|Reported Event|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26463|NCT02294734|E1|Reported Event|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
26464|NCT02294682|B3|Baseline|Total|Total of all reporting groups
26465|NCT02294682|B2|Baseline|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26466|NCT02294682|B1|Baseline|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26467|NCT02294682|P2|Participant Flow|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26468|NCT02294682|P1|Participant Flow|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26469|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26470|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26471|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26472|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26473|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26474|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26475|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
39231|NCT02171195|O4|Outcome|Group 3 100 mg|BIA 2-093 100mg or placebo
26476|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26477|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26478|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26479|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26480|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26481|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26482|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26483|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26484|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26485|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26486|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26487|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26488|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26489|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26490|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26491|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26722|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs
Isovue: iodine contrast"
26492|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26493|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26494|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26495|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26496|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26497|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26498|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26499|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26500|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26501|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26502|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26503|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26504|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26505|NCT02294682|E2|Reported Event|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26506|NCT02294682|E1|Reported Event|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
26507|NCT02294604|B4|Baseline|Total|Total of all reporting groups
26508|NCT02294604|B3|Baseline|Group C|"Traditional scrub formation with 4% chlorhexidine
chlorhexidine"
26509|NCT02294604|B2|Baseline|Group I|"Traditional scrub formation with 10 % povidone-iodine
povidone-iodine"
26510|NCT02294604|B1|Baseline|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers
ethyl alcochol, chlorhexidine and moisturizers"
26513|NCT02294604|P1|Participant Flow|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers
ethyl alcochol, chlorhexidine and moisturizers"
26514|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine
chlorhexidine"
26515|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine
povidone-iodine"
26516|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers
ethyl alcochol, chlorhexidine and moisturizers"
26517|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine
chlorhexidine"
26518|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine
povidone-iodine"
26519|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers
ethyl alcochol, chlorhexidine and moisturizers"
26520|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine
chlorhexidine"
26521|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine
povidone-iodine"
26522|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers
ethyl alcochol, chlorhexidine and moisturizers"
26523|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine
chlorhexidine"
26524|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine
povidone-iodine"
26525|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers
ethyl alcochol, chlorhexidine and moisturizers"
26526|NCT02294604|E3|Reported Event|Group C|"Traditional scrub formation with 4% chlorhexidine
chlorhexidine"
26527|NCT02294604|E2|Reported Event|Group I|"Traditional scrub formation with 10 % povidone-iodine
povidone-iodine"
26528|NCT02294604|E1|Reported Event|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers
ethyl alcochol, chlorhexidine and moisturizers"
26529|NCT02294461|B3|Baseline|Total|Total of all reporting groups
26530|NCT02294461|B2|Baseline|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26531|NCT02294461|B1|Baseline|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26532|NCT02294461|P2|Participant Flow|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26533|NCT02294461|P1|Participant Flow|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26534|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26535|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26536|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
26537|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
26538|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
26539|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26540|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite.
26541|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite).
26542|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite.
26543|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26544|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite.
26545|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|Active metabolite.
26546|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite.
26547|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26548|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite.
26549|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite).
26550|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite.
27293|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
26551|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26552|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
26553|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
26554|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
26555|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26556|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
26557|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
26558|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
26559|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed.
26560|NCT02294461|O4|Outcome|Enzalutamide Plus M2|
26561|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
26562|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
26563|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26564|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
26565|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
26566|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
26567|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26568|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26569|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.disease progression were centrally confirmed.
26570|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26571|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26572|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26573|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26574|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26575|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26576|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26577|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26578|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
39232|NCT02171195|O3|Outcome|Group 2 50 mg|BIA 2-093 50mg or placebo
26579|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26580|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26581|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26582|NCT02294461|E2|Reported Event|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26583|NCT02294461|E1|Reported Event|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
26584|NCT02294019|B1|Baseline|Ibuprofen|All participants who purchased at least 1 carton of study medication.
26585|NCT02294019|P1|Participant Flow|Ibuprofen|All participants who purchased at least 1 carton of study medication.
26586|NCT02294019|O1|Outcome|Ibuprofen|Participants who purchased and used orally 400 mg caplets of Ibuprofen after reading the drug facts label (DFL), and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
26587|NCT02294019|O1|Outcome|Ibuprofen|Participants who purchased and used orally 400 mg caplets of Ibuprofen after reading the drug facts label (DFL), and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
26588|NCT02294019|E1|Reported Event|Ibuprofen (Safety Population)|Subjects in the actual use population, and any other subject who provided any follow up information indicating that they used the study product at least once during the study
26589|NCT02293538|B3|Baseline|Total|Total of all reporting groups
26590|NCT02293538|B2|Baseline|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26591|NCT02293538|B1|Baseline|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26592|NCT02293538|P2|Participant Flow|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26593|NCT02293538|P1|Participant Flow|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26594|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26595|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26596|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26597|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26598|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26599|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26600|NCT02293538|O1|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26601|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26602|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26603|NCT02293538|E2|Reported Event|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26604|NCT02293538|E1|Reported Event|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
26605|NCT02292433|B4|Baseline|Total|Total of all reporting groups
26622|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26723|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs
Isovue: iodine contrast"
27294|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
26606|NCT02292433|B3|Baseline|Placebo Then PF-04937319 100 mg Then PF-04937319 250 mg|Participants received placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the first intervention period followed by PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
26607|NCT02292433|B2|Baseline|PF-04937319 100 mg Then Placebo Then PF-04937319 250 mg|Participants received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
26608|NCT02292433|B1|Baseline|PF-04937319 100 mg Then PF-04937319 250 mg Then Placebo|Participants received PF-04937319 100 milligram (mg) orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
26609|NCT02292433|P3|Participant Flow|Placebo Then PF-04937319 100 mg Then PF-04937319 250 mg|Participants received placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the first intervention period followed by PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
26610|NCT02292433|P2|Participant Flow|PF-04937319 100 mg Then Placebo Then PF-04937319 250 mg|Participants received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
26611|NCT02292433|P1|Participant Flow|PF-04937319 100 mg Then PF-04937319 250 mg Then Placebo|Participants received PF-04937319 100 milligram (mg) orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
26612|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
26613|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26614|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26615|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
26616|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26617|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26618|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
26619|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26620|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26621|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
26720|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs
Isovue: iodine contrast"
26721|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs
Isovue: iodine contrast"
26623|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26624|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26625|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26626|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26627|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26628|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26629|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26630|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26631|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26632|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26633|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26634|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26635|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26636|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26637|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26638|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26639|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26640|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26641|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26642|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26643|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26644|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26645|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26646|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
39233|NCT02171195|O2|Outcome|Group 1 20 mg|BIA 2-093 20mg or placebo.
26647|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26648|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26649|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26650|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26651|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26652|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26653|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26654|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26655|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26656|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26657|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26658|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26659|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26660|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26661|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26662|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26663|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26664|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26665|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26666|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26667|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26668|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26669|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26670|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
39234|NCT02171195|O1|Outcome|Placebo|Placebo, PLC
26671|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26672|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
26673|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26674|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26675|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
26676|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26677|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26678|NCT02292433|E3|Reported Event|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
26679|NCT02292433|E2|Reported Event|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
26680|NCT02292433|E1|Reported Event|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
26681|NCT02292212|B1|Baseline|Single Arm|Total 16 weeks, divided to 3 phases, Pre-ViE phase (2W by control device), ViE phase (12W by target device, ViE-21) and Post-ViE phase (2W by control device).
26682|NCT02292212|P1|Participant Flow|Single Arm|Total 16 weeks, divided to 3 periods, Pre-ViE phase (2W by control device), ViE phase (12W by target device, ViE-21) and Post-ViE phase (2W by control device).
26683|NCT02292212|O3|Outcome|Post ViE Phase|Two weeks (six sessions) on the same model control dialyzer used during the pre-ViE phase
26684|NCT02292212|O2|Outcome|ViE Phase|12 weeks (36 sessions) on the ViE-21
26685|NCT02292212|O1|Outcome|Pre-ViE Phase|Two weeks (six sessions) on the control dialyzer
26686|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
26687|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
26688|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
26689|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
26690|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
26691|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
26692|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
26693|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
26694|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
26695|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
26696|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
26697|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
26698|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
26699|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
26700|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
26701|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
26702|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
26703|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
26704|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
26705|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
26706|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
26707|NCT02292212|O3|Outcome|ViE Phase (2)|13th week of dialysis with ViE-21
26708|NCT02292212|O2|Outcome|ViE Phase (1)|Seventh week of dialysis with ViE-21
26709|NCT02292212|O1|Outcome|Pre-ViE Phase|The first week of dialysis with control dialyzer
26710|NCT02292212|E3|Reported Event|Post-ViE Phase|Two weeks (six sessions) on the same model control dialyzer used during the pre-ViE phase
26711|NCT02292212|E2|Reported Event|ViE Phase|12 weeks (36 sessions) on ViE-21
26712|NCT02292212|E1|Reported Event|Pre-ViE Phase|Two weeks (six sessions) on control dialyzer
26713|NCT02291718|B4|Baseline|Total|Total of all reporting groups
26714|NCT02291718|B3|Baseline|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
26715|NCT02291718|B2|Baseline|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
26716|NCT02291718|B1|Baseline|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
26717|NCT02291718|P3|Participant Flow|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
26718|NCT02291718|P2|Participant Flow|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
26719|NCT02291718|P1|Participant Flow|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
26724|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs
Isovue: iodine contrast"
26725|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs
Isovue: iodine contrast"
26726|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs
Isovue: iodine contrast"
26727|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs
Isovue: iodine contrast"
26728|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs
Isovue: iodine contrast"
26729|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs
Isovue: iodine contrast"
26730|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs
Isovue: iodine contrast"
26731|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs
Isovue: iodine contrast"
26732|NCT02291718|E3|Reported Event|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
26733|NCT02291718|E2|Reported Event|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
26734|NCT02291718|E1|Reported Event|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
26735|NCT02291679|B4|Baseline|Total|Total of all reporting groups
26736|NCT02291679|B3|Baseline|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
26737|NCT02291679|B2|Baseline|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26738|NCT02291679|B1|Baseline|Placebo|Matching placebo, once daily for 12 weeks
26739|NCT02291679|P3|Participant Flow|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
26740|NCT02291679|P2|Participant Flow|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26741|NCT02291679|P1|Participant Flow|Placebo|Matching placebo, once daily for 12 weeks
26742|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26743|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26744|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26745|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26746|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26747|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26748|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26749|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26750|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26751|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26752|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26753|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26754|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26755|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26756|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26757|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26758|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26759|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26760|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26761|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26762|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26763|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26764|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26765|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
26766|NCT02291679|E3|Reported Event|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
26767|NCT02291679|E2|Reported Event|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
26768|NCT02291679|E1|Reported Event|Placebo|Matching placebo, once daily for 12 weeks
26769|NCT02291510|B5|Baseline|Total|Total of all reporting groups
26770|NCT02291510|B4|Baseline|Sequence 4: DACB|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
26771|NCT02291510|B3|Baseline|Sequence 3: CDBA|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
26772|NCT02291510|B2|Baseline|Sequence 2: BCAD|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
26773|NCT02291510|B1|Baseline|Sequence 1: ABDC|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
26774|NCT02291510|P4|Participant Flow|Sequence 4: DACB|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
26775|NCT02291510|P3|Participant Flow|Sequence 3: CDBA|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
26776|NCT02291510|P2|Participant Flow|Sequence 2: BCAD|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
26777|NCT02291510|P1|Participant Flow|Sequence 1: ABDC|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
26778|NCT02291510|O4|Outcome|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release
Met XR: metformin extended-release tablets"
26779|NCT02291510|O3|Outcome|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release
Met IR: metformin immediate-release tablets"
26780|NCT02291510|O2|Outcome|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release
Met DR: metformin delayed-release tablets"
26781|NCT02291510|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release
Met DR: metformin delayed-release tablets"
39529|NCT02169466|B5|Baseline|Total|Total of all reporting groups
26782|NCT02291510|O4|Outcome|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release
Met XR: metformin extended-release tablets"
26783|NCT02291510|O3|Outcome|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release
Met IR: metformin immediate-release tablets"
26784|NCT02291510|O2|Outcome|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release
Met DR: metformin delayed-release tablets"
26785|NCT02291510|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release
Met DR: metformin delayed-release tablets"
26786|NCT02291510|E4|Reported Event|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release
Met XR: metformin extended-release tablets"
26787|NCT02291510|E3|Reported Event|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release
Met IR: metformin immediate-release tablets"
26788|NCT02291510|E2|Reported Event|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release
Met DR: metformin delayed-release tablets"
26789|NCT02291510|E1|Reported Event|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release
Met DR: metformin delayed-release tablets"
26790|NCT02291419|B3|Baseline|Total|Total of all reporting groups
26791|NCT02291419|B2|Baseline|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally
aspirin: aspirin 81 mg daily"
26792|NCT02291419|B1|Baseline|Ticagrelor|"ticagrelor 90mg bid
ticagrelor: ticagrelor 90 mg bid"
26793|NCT02291419|P2|Participant Flow|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally
aspirin: aspirin 81 mg daily"
26794|NCT02291419|P1|Participant Flow|Ticagrelor|"ticagrelor 90mg bid
ticagrelor: ticagrelor 90 mg bid"
26795|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally
aspirin: aspirin 81 mg daily"
26796|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid
ticagrelor: ticagrelor 90 mg bid"
26797|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally
aspirin: aspirin 81 mg daily"
26798|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid
ticagrelor: ticagrelor 90 mg bid"
26799|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally
aspirin: aspirin 81 mg daily"
26800|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid
ticagrelor: ticagrelor 90 mg bid"
26801|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally
aspirin: aspirin 81 mg daily"
26802|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid
ticagrelor: ticagrelor 90 mg bid"
26803|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally
aspirin: aspirin 81 mg daily"
26804|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid
ticagrelor: ticagrelor 90 mg bid"
26805|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally
aspirin: aspirin 81 mg daily"
26806|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid
ticagrelor: ticagrelor 90 mg bid"
26807|NCT02291419|E2|Reported Event|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally
aspirin: aspirin 81 mg daily"
26808|NCT02291419|E1|Reported Event|Ticagrelor|"ticagrelor 90mg bid
ticagrelor: ticagrelor 90 mg bid"
26809|NCT02290821|B3|Baseline|Total|Total of all reporting groups
26810|NCT02290821|B2|Baseline|Placebo|"Placebo
diclofenac sodium gel 1%"
26811|NCT02290821|B1|Baseline|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%
diclofenac sodium gel 1%"
26812|NCT02290821|P2|Participant Flow|Placebo|"Placebo
diclofenac sodium gel 1%"
26813|NCT02290821|P1|Participant Flow|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%
diclofenac sodium gel 1%"
26814|NCT02290821|O2|Outcome|Placebo|"Placebo
diclofenac sodium gel 1%"
26815|NCT02290821|O1|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%
diclofenac sodium gel 1%"
26816|NCT02290821|E2|Reported Event|Placebo|"Placebo
diclofenac sodium gel 1%"
26817|NCT02290821|E1|Reported Event|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%
diclofenac sodium gel 1%"
26818|NCT02290509|B3|Baseline|Total|Total of all reporting groups
26819|NCT02290509|B2|Baseline|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
26820|NCT02290509|B1|Baseline|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent: Intramuscular injection of study vaccine"
26821|NCT02290509|P2|Participant Flow|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
26822|NCT02290509|P1|Participant Flow|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent: Intramuscular injection of study vaccine"
26823|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
26824|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent: Intramuscular injection of study vaccine"
26825|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
27295|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
26826|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent: Intramuscular injection of study vaccine"
26827|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
26828|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent: Intramuscular injection of study vaccine"
26829|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
26830|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent: Intramuscular injection of study vaccine"
26831|NCT02290509|E2|Reported Event|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
26832|NCT02290509|E1|Reported Event|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent: Intramuscular injection of study vaccine"
26833|NCT02289989|B3|Baseline|Total|Total of all reporting groups
26834|NCT02289989|B2|Baseline|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26835|NCT02289989|B1|Baseline|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26836|NCT02289989|P2|Participant Flow|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26837|NCT02289989|P1|Participant Flow|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26838|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26839|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26840|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26841|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26842|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26843|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26844|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26845|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26878|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26846|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26847|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26848|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26849|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26850|NCT02289989|E2|Reported Event|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26851|NCT02289989|E1|Reported Event|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
26852|NCT02289963|B3|Baseline|Total|Total of all reporting groups
26853|NCT02289963|B2|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26854|NCT02289963|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26855|NCT02289963|P2|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26856|NCT02289963|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
26857|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26858|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26859|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26860|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26861|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26862|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26863|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26864|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26865|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26866|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26867|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26868|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26869|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26870|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26871|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26872|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26873|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26874|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26875|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26876|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26877|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26879|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26880|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26881|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26882|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26883|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26884|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26885|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26886|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26887|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26888|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26889|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26890|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26891|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26892|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26893|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26894|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26895|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26896|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26897|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26898|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26899|NCT02289963|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
26900|NCT02289963|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
26901|NCT02289963|E2|Reported Event|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable LMT (mean exposure of 24 weeks).
26902|NCT02289963|E1|Reported Event|Placebo Q2W|Participants exposed to Placebo (for Alirocumab) SC injection Q2W added to stable LMT (mean exposure of 23 weeks).
26903|NCT02289755|B1|Baseline|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
26904|NCT02289755|P1|Participant Flow|ALLN-177|ALLN-177 (5 capsules; 7,500 units/meal) by mouth 3 times a day with main meals for 4 consecutive days.
26905|NCT02289755|O1|Outcome|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
26906|NCT02289755|O1|Outcome|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
26907|NCT02289755|E1|Reported Event|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
26908|NCT02289742|B3|Baseline|Total|Total of all reporting groups
26909|NCT02289742|B2|Baseline|Astigmats|Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
26910|NCT02289742|B1|Baseline|Presbyopes|Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
26911|NCT02289742|P4|Participant Flow|Astigmats Sphere/Toric|Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A toric contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
26912|NCT02289742|P3|Participant Flow|Astigmats Toric/Sphere|Nelfilcon A toric contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
26913|NCT02289742|P2|Participant Flow|Presbyopes Sphere/MF|Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
26914|NCT02289742|P1|Participant Flow|Presbyopes MF/Sphere|Nelfilcon A multifocal contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
26915|NCT02289742|O4|Outcome|Astigmats / Sphere|Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
26916|NCT02289742|O3|Outcome|Astigmats / Toric|Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 ( in a crossover design)
26917|NCT02289742|O2|Outcome|Presbyopes / Sphere|Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
26918|NCT02289742|O1|Outcome|Presbyopes / Multifocal|Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2
26919|NCT02289742|O4|Outcome|Astigmats / Sphere|Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
26920|NCT02289742|O3|Outcome|Astigmats / Toric|Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design)
26921|NCT02289742|O2|Outcome|Presbyopes / Sphere|Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
26922|NCT02289742|O1|Outcome|Presbyopes / Multifocal|Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2
26923|NCT02289742|E7|Reported Event|Astigmats / Sphere Second Exposure|All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3
26924|NCT02289742|E6|Reported Event|Astigmats / Sphere First Exposure|All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized
26925|NCT02289742|E5|Reported Event|Astigmats / Toric|All subjects exposed to nelfilcon A toric contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized
26926|NCT02289742|E4|Reported Event|Presbyopes / Sphere Second Exposure|All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3
26927|NCT02289742|E3|Reported Event|Presbyopes / Sphere First Exposure|All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized
26928|NCT02289742|E2|Reported Event|Presbyopes / Multifocal|All subjects exposed to nelfilcon A multifocal contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized
26929|NCT02289742|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
26930|NCT02289469|B3|Baseline|Total|Total of all reporting groups
26931|NCT02289469|B2|Baseline|Usual Care|Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.
26932|NCT02289469|B1|Baseline|PictureRx|Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications
26933|NCT02289469|P2|Participant Flow|Usual Care|Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.
26934|NCT02289469|P1|Participant Flow|PictureRx|Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications
26935|NCT02289469|O2|Outcome|Usual Care|Usual medication history process
26936|NCT02289469|O1|Outcome|PictureRx|"PictureRx medication history platform
PictureRx medication history platform: Tablet PC-based tool to take more complete and accurate medication history"
26937|NCT02289469|O2|Outcome|Usual Care|Usual medication history process
26938|NCT02289469|O1|Outcome|PictureRx|"PictureRx medication history platform
PictureRx medication history platform: Tablet PC-based tool to take more complete and accurate medication history"
26939|NCT02289469|E2|Reported Event|Usual Care|Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.
26940|NCT02289469|E1|Reported Event|PictureRx|Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications
26941|NCT02289105|B3|Baseline|Total|Total of all reporting groups
26942|NCT02289105|B2|Baseline|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
26943|NCT02289105|B1|Baseline|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.
Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
26944|NCT02289105|P2|Participant Flow|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
26945|NCT02289105|P1|Participant Flow|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.
Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
26946|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
26947|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.
Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
26948|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
27001|NCT02288312|P2|Participant Flow|Group B|"Period 1 - ESL 800 mg (2x400mg), in fasting (4 days) Period 2 - ESL 800 mg, in fasting (4 days) Period 3 - ESL 800 mg, in fed (4 days)
Washout periods - 7 days between dosing days"
26949|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.
Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
26950|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
26951|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.
Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
26952|NCT02289105|E2|Reported Event|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
26953|NCT02289105|E1|Reported Event|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.
Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
26954|NCT02289079|B3|Baseline|Total|Total of all reporting groups
26955|NCT02289079|B2|Baseline|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine
Bupivacaine"
26956|NCT02289079|B1|Baseline|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine
liposomal bupivacaine"
26957|NCT02289079|P2|Participant Flow|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine
Bupivacaine"
26958|NCT02289079|P1|Participant Flow|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine
liposomal bupivacaine"
26959|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine
Bupivacaine"
26960|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine
liposomal bupivacaine"
26961|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine
Bupivacaine"
26962|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine
liposomal bupivacaine"
26963|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine
Bupivacaine"
26964|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine
liposomal bupivacaine"
26965|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine
Bupivacaine"
26966|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine
liposomal bupivacaine"
26967|NCT02289079|E2|Reported Event|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine
Bupivacaine"
26968|NCT02289079|E1|Reported Event|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine
liposomal bupivacaine"
26969|NCT02288364|B3|Baseline|Total|Total of all reporting groups
26970|NCT02288364|B2|Baseline|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26971|NCT02288364|B1|Baseline|1% Lidocaine|1% Lidocaine alone.
26972|NCT02288364|P2|Participant Flow|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26973|NCT02288364|P1|Participant Flow|1% Lidocaine|1% Lidocaine alone.
26974|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26975|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
26976|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26977|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
26978|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26979|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
26980|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26981|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
26982|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26983|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
26984|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26985|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
26986|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26987|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
26988|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26989|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
26990|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26991|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
26992|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26993|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
26994|NCT02288364|E2|Reported Event|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
26995|NCT02288364|E1|Reported Event|1% Lidocaine|1% Lidocaine alone.
26996|NCT02288312|B4|Baseline|Total|Total of all reporting groups
26997|NCT02288312|B3|Baseline|Sequence C|Period 1 - ESL 800 mg, in fed Period 2 - ESL 800 mg (2x400mg), in fasting Period 3 - ESL 800 mg, in fasting
26998|NCT02288312|B2|Baseline|Sequence B|Period 1 - ESL 800 mg (2x400mg), in fasting Period 2 - ESL 800 mg, in fasting Period 3 - ESL 800 mg, in fed
26999|NCT02288312|B1|Baseline|Sequence A|Period 1 - ESL 800 mg, in fasting Period 2 - ESL 800 mg, in fed Period 3 - ESL 800 mg (2x400mg), in fasting
27000|NCT02288312|P3|Participant Flow|Group C|"Period 1 - ESL 800 mg, in fed (4 days) Period 2 - ESL 800 mg (2x400mg), in fasting (4 days) Period 3 - ESL 800 mg, in fasting (4 days)
Washout periods - 7 days between dosing days"
27002|NCT02288312|P1|Participant Flow|Group A|"Period 1 - ESL 800 mg, in fasting (4 days) Period 2 - ESL 800 mg, in fed (4 days) Period 3 - ESL 800 mg (2x400mg), in fasting (4 days)
Washout periods - 7 days between dosing days"
27003|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.
BIA 2-093"
27004|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.
BIA 2-093"
27005|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.
BIA 2-093"
27006|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.
BIA 2-093"
27007|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.
BIA 2-093"
27008|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.
BIA 2-093"
27009|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.
BIA 2-093"
27010|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.
BIA 2-093"
27011|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.
BIA 2-093"
27012|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.
BIA 2-093"
27013|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.
BIA 2-093"
27014|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.
BIA 2-093"
27015|NCT02288312|E3|Reported Event|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.
BIA 2-093"
27016|NCT02288312|E2|Reported Event|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.
BIA 2-093"
27017|NCT02288312|E1|Reported Event|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.
BIA 2-093"
27018|NCT02288273|B3|Baseline|Total|Total of all reporting groups
27019|NCT02288273|B2|Baseline|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
27020|NCT02288273|B1|Baseline|Once Weekly (EQW) + Met|Bydureon EQW + Metformin XR 1500-2000 mg
27021|NCT02288273|P2|Participant Flow|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
27022|NCT02288273|P1|Participant Flow|Once Weekly (EQW) + Met|Bydureon EQW + Metformin XR 1500-2000 mg
27023|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
27024|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
27025|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
27026|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
27027|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
27028|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
27029|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
27030|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
27031|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
27032|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
27033|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
27034|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
27035|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
27036|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
27037|NCT02288273|E2|Reported Event|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
27038|NCT02288273|E1|Reported Event|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
27039|NCT02287779|B9|Baseline|Total|Total of all reporting groups
27040|NCT02287779|B8|Baseline|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27041|NCT02287779|B7|Baseline|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27042|NCT02287779|B6|Baseline|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27043|NCT02287779|B5|Baseline|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27044|NCT02287779|B4|Baseline|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27045|NCT02287779|B3|Baseline|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
27046|NCT02287779|B2|Baseline|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
27047|NCT02287779|B1|Baseline|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days
27048|NCT02287779|P8|Participant Flow|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27049|NCT02287779|P7|Participant Flow|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27050|NCT02287779|P6|Participant Flow|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27051|NCT02287779|P5|Participant Flow|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27052|NCT02287779|P4|Participant Flow|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27053|NCT02287779|P3|Participant Flow|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
27054|NCT02287779|P2|Participant Flow|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
27055|NCT02287779|P1|Participant Flow|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27056|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27057|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27058|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27059|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27060|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27061|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
27062|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
27063|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27064|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27065|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27066|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27067|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27068|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27069|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
27070|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27071|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27072|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27073|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27074|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27075|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27076|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27077|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
27078|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27079|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27080|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27081|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27082|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27083|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27084|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27085|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
27086|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27087|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27088|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27089|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27090|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27091|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27092|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27093|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
27094|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27095|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27096|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27097|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27098|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27099|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27100|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27101|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
27285|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27102|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27103|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27104|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27105|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27106|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27107|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27108|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27109|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
27110|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27111|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days
27112|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27113|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27114|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27115|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27116|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27117|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
27118|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27119|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27120|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27121|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27122|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27123|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27124|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27125|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
27126|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27127|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27128|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27129|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27130|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27131|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27132|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27133|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
27134|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27135|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27136|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27137|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27138|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27139|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27140|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27141|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
27142|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27143|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27144|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27145|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27146|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27147|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27148|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27149|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
27150|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27151|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27152|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27153|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27154|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27155|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27156|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27157|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
27158|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27159|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27160|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27161|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27162|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27163|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27164|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27165|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
27166|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27167|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27168|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27169|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27170|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27171|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27172|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27173|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
27174|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
27175|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27176|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27177|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27178|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27179|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27180|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27181|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
27182|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
27183|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27184|NCT02287779|E8|Reported Event|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
27185|NCT02287779|E7|Reported Event|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
27186|NCT02287779|E6|Reported Event|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
27187|NCT02287779|E5|Reported Event|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
27188|NCT02287779|E4|Reported Event|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
27189|NCT02287779|E3|Reported Event|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
27190|NCT02287779|E2|Reported Event|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
40308|NCT02159547|B3|Baseline|Total|Total of all reporting groups
27191|NCT02287779|E1|Reported Event|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
27192|NCT02287623|B3|Baseline|Total|Total of all reporting groups
27193|NCT02287623|B2|Baseline|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine
bupivacaine: patients will receive a tap with bupivacaine"
27194|NCT02287623|B1|Baseline|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine
liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
27195|NCT02287623|P2|Participant Flow|Bupivacaine TAP|Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine.
27196|NCT02287623|P1|Participant Flow|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine
liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 10 mL of liposomal bupivacaine and 20 mL of normal saline."
27197|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine
bupivacaine: patients will receive a tap with bupivacaine"
27198|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine
liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
27199|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine
bupivacaine: patients will receive a tap with bupivacaine"
27200|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine
liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
27201|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine
bupivacaine: patients will receive a tap with bupivacaine"
27202|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine
liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
27203|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine
bupivacaine: patients will receive a tap with bupivacaine"
27204|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine
liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
27205|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine
bupivacaine: patients will receive a tap with bupivacaine"
27206|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine
liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
27207|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine
bupivacaine: patients will receive a tap with bupivacaine"
27208|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine
liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
27209|NCT02287623|E2|Reported Event|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine
bupivacaine: patients will receive a tap with bupivacaine"
27210|NCT02287623|E1|Reported Event|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine
liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
27211|NCT02287610|B1|Baseline|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27212|NCT02287610|P1|Participant Flow|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27213|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27214|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27215|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27216|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27217|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27218|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27286|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27287|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27219|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27220|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27221|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27222|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27223|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27224|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27225|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27226|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27227|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27228|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27229|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27230|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27231|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27232|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27233|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27234|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27235|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27236|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27237|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27238|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27239|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27240|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27241|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27242|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27243|NCT02287610|E1|Reported Event|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
27244|NCT02287415|B1|Baseline|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
BIA 2-093
Warfarin"
27245|NCT02287415|P1|Participant Flow|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
BIA 2-093
Warfarin"
27246|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
BIA 2-093
Warfarin"
27247|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
BIA 2-093
Warfarin"
27248|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
BIA 2-093
Warfarin"
27249|NCT02287415|E1|Reported Event|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
BIA 2-093
Warfarin"
27250|NCT02287402|B1|Baseline|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27251|NCT02287402|P1|Participant Flow|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27252|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27253|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27254|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27255|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27256|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27257|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27258|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27259|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27260|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27261|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27262|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27263|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27264|NCT02287402|E1|Reported Event|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
27265|NCT02287376|B1|Baseline|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27266|NCT02287376|P1|Participant Flow|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27267|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27268|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27269|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27270|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27271|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27272|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27273|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27274|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27275|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27276|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27277|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27278|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27279|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27280|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27281|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27282|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27283|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27284|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27298|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27299|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27300|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27301|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27302|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27303|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27304|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27305|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27306|NCT02287376|O1|Outcome|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27307|NCT02287376|E1|Reported Event|Cambia®|Diclofenac Potassium for Oral Solution (NSAID), 50 mg
27308|NCT02287350|B1|Baseline|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27309|NCT02287350|P1|Participant Flow|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27310|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27311|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27312|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27313|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27314|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27315|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27316|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27317|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27318|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27319|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
28970|NCT02269475|E1|Reported Event|MEDI3250|MEDI3250, 0.2mL as nasal spray
27379|NCT02286518|P3|Participant Flow|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
41621|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
27320|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27321|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27322|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27323|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27324|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27325|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27326|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27327|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27328|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27329|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27330|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27331|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27332|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27333|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27334|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27335|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27336|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27337|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27338|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27339|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27340|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27341|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27342|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27343|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27344|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27345|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27346|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27347|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27348|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27349|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27350|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27351|NCT02287350|O1|Outcome|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27352|NCT02287350|E1|Reported Event|Diclofenac Potassium Oral Solution|"5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."
27353|NCT02286518|B15|Baseline|Total|Total of all reporting groups
27354|NCT02286518|B14|Baseline|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27355|NCT02286518|B13|Baseline|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27356|NCT02286518|B12|Baseline|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27357|NCT02286518|B11|Baseline|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27358|NCT02286518|B10|Baseline|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27359|NCT02286518|B9|Baseline|Part 2 Cohort 4: TAK-114 20 mg Fed + TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, once on Day 1, fed state in period 2 (3 days), followed by a 14 day washout period, further followed by TAK-114 20 mg, capsule, orally, once on Day 1 in fasted state in period 1, in healthy Japanese participants.
27360|NCT02286518|B8|Baseline|Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.
27361|NCT02286518|B7|Baseline|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27362|NCT02286518|B6|Baseline|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27363|NCT02286518|B5|Baseline|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27364|NCT02286518|B4|Baseline|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27365|NCT02286518|B3|Baseline|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27366|NCT02286518|B2|Baseline|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27367|NCT02286518|B1|Baseline|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27368|NCT02286518|P14|Participant Flow|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27369|NCT02286518|P13|Participant Flow|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27370|NCT02286518|P12|Participant Flow|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27371|NCT02286518|P11|Participant Flow|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27372|NCT02286518|P10|Participant Flow|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27373|NCT02286518|P9|Participant Flow|Part 2 Cohort 4: TAK-114 Fed + TAK-114 Fasted|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 2 (3 days), in Japanese participants.
27374|NCT02286518|P8|Participant Flow|Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.
27375|NCT02286518|P7|Participant Flow|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27376|NCT02286518|P6|Participant Flow|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27377|NCT02286518|P5|Participant Flow|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27378|NCT02286518|P4|Participant Flow|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27380|NCT02286518|P2|Participant Flow|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27381|NCT02286518|P1|Participant Flow|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27382|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27383|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27384|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27385|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27386|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27387|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27388|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27389|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27390|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27391|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27392|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27393|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27394|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27395|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27396|NCT02286518|O12|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27397|NCT02286518|O11|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27398|NCT02286518|O10|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27399|NCT02286518|O9|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27400|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27401|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27402|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27403|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27404|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27405|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27406|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27407|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27408|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27409|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27410|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27411|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27412|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27413|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27414|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27415|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27416|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27417|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27418|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27419|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27420|NCT02286518|O12|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27421|NCT02286518|O11|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27422|NCT02286518|O10|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27423|NCT02286518|O9|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27424|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27425|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27426|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27427|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27428|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27429|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27430|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27431|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27432|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27433|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27434|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27435|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27436|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27437|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27438|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27439|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27440|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27441|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27442|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27443|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27444|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27445|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27446|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27447|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27448|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27449|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27450|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27451|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27452|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27453|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27454|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27455|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27456|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27457|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27458|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27459|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27460|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27461|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27462|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27463|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27464|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27465|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27466|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27467|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27468|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27469|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27470|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27471|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27472|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27473|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27474|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27475|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27476|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27477|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27478|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27479|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27480|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27481|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27482|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27483|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27484|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27485|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27486|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27487|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27488|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
41622|NCT02150460|E2|Reported Event|Group 2|Two-site peribulbar injection
27489|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27490|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27491|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27492|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27493|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27494|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27495|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27496|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27497|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27498|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27499|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27500|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27501|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27502|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27503|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27504|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27505|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27506|NCT02286518|E14|Reported Event|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27507|NCT02286518|E13|Reported Event|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
27508|NCT02286518|E12|Reported Event|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27509|NCT02286518|E11|Reported Event|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27510|NCT02286518|E10|Reported Event|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
27511|NCT02286518|E9|Reported Event|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27512|NCT02286518|E8|Reported Event|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
27513|NCT02286518|E7|Reported Event|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27514|NCT02286518|E6|Reported Event|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27515|NCT02286518|E5|Reported Event|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
27516|NCT02286518|E4|Reported Event|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27517|NCT02286518|E3|Reported Event|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27518|NCT02286518|E2|Reported Event|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27519|NCT02286518|E1|Reported Event|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
27520|NCT02286193|B1|Baseline|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
27521|NCT02286193|P1|Participant Flow|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
27522|NCT02286193|O1|Outcome|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
28971|NCT02269098|B3|Baseline|Total|Total of all reporting groups
27523|NCT02286193|O1|Outcome|Patients Presenting to Community Liaison|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
27524|NCT02286193|E1|Reported Event|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
27525|NCT02286102|B3|Baseline|Total|Total of all reporting groups
27526|NCT02286102|B2|Baseline|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
27527|NCT02286102|B1|Baseline|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
27528|NCT02286102|P2|Participant Flow|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
27529|NCT02286102|P1|Participant Flow|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
27530|NCT02286102|O2|Outcome|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
27531|NCT02286102|O1|Outcome|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
27532|NCT02286102|O2|Outcome|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
27533|NCT02286102|O1|Outcome|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
27534|NCT02286102|O2|Outcome|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
27535|NCT02286102|O1|Outcome|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
27536|NCT02286102|E2|Reported Event|Constavac|"Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively"
27537|NCT02286102|E1|Reported Event|OrthoPAT|"Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively"
27538|NCT02285998|B3|Baseline|Total|Total of all reporting groups
27539|NCT02285998|B2|Baseline|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27540|NCT02285998|B1|Baseline|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27541|NCT02285998|P2|Participant Flow|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27542|NCT02285998|P1|Participant Flow|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27543|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27544|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27545|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27546|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
29889|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM
PRFM
Double Row"
27839|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
41623|NCT02150460|E1|Reported Event|Group 1|One-site peribulbar injection
27547|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27548|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27549|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27550|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27551|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27552|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27553|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27554|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27555|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27556|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27557|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27558|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27559|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27560|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27561|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27562|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27563|NCT02285998|E2|Reported Event|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
27564|NCT02285998|E1|Reported Event|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
27565|NCT02285270|B1|Baseline|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT
FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
27840|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27566|NCT02285270|P1|Participant Flow|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT
FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
27567|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT
FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
27568|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT
FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
27569|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT
FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
27570|NCT02285270|E1|Reported Event|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT
FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
27571|NCT02284880|B3|Baseline|Total|Total of all reporting groups
27572|NCT02284880|B2|Baseline|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
27573|NCT02284880|B1|Baseline|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
27574|NCT02284880|P4|Participant Flow|800 mg BIA 2-093 Group 2|In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
27575|NCT02284880|P3|Participant Flow|800 mg BIA 2-093 Group 1|In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
27576|NCT02284880|P2|Participant Flow|400 mg BIA 2-093 Group 2|In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
27577|NCT02284880|P1|Participant Flow|400 mg BIA 2-093 Group 1|In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
27578|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
27579|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
27580|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
27581|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
27582|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
27583|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
27584|NCT02284880|E6|Reported Event|After Follow-up Visit|After Follow-up visit ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation TBM - To be marketed
27585|NCT02284880|E5|Reported Event|800 mg Tablet of ESL (TBM)|800 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
27586|NCT02284880|E4|Reported Event|800 mg Tablet of ESL (MF)|800 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
27587|NCT02284880|E3|Reported Event|400 mg Tablet of ESL (TBM)|400 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
27588|NCT02284880|E2|Reported Event|400 mg Tablet of ESL (MF)|400 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
27589|NCT02284880|E1|Reported Event|Before Treatment|Before treatment with ESL ESL - Eslicarbazepine acetate, BIA 2-093
27590|NCT02284867|B3|Baseline|Total|Total of all reporting groups
27707|NCT02283840|B3|Baseline|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27591|NCT02284867|B2|Baseline|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .
immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
27592|NCT02284867|B1|Baseline|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .
immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
27593|NCT02284867|P2|Participant Flow|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .
immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
27594|NCT02284867|P1|Participant Flow|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .
immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
27595|NCT02284867|O2|Outcome|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .
immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
27596|NCT02284867|O1|Outcome|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .
immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
27597|NCT02284867|O2|Outcome|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .
immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
27598|NCT02284867|O1|Outcome|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .
immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
27634|NCT02284555|P1|Participant Flow|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).
Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
27708|NCT02283840|B2|Baseline|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27599|NCT02284867|E2|Reported Event|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .
immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
27600|NCT02284867|E1|Reported Event|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .
immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
27601|NCT02284854|B3|Baseline|Total|Total of all reporting groups
27602|NCT02284854|B2|Baseline|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + 400 mg twice-daily
27603|NCT02284854|B1|Baseline|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
27604|NCT02284854|P2|Participant Flow|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
27605|NCT02284854|P1|Participant Flow|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
27606|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
27607|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
27608|NCT02284854|O1|Outcome|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
27609|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
27610|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
27611|NCT02284854|O1|Outcome|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
27612|NCT02284854|E9|Reported Event|After Treatment|Group A and B After treatment
27613|NCT02284854|E8|Reported Event|Before Treatment|Group A and B Before treatment
27614|NCT02284854|E7|Reported Event|ESL 800 mg + CBZ 400 mg|Group A ESL 800 mg + CBZ 400 mg
27615|NCT02284854|E6|Reported Event|ESL 800 mg + CBZ 200 mg|Group A ESL 800 mg + CBZ 200 mg
27616|NCT02284854|E5|Reported Event|ESL 800 mg|Group A ESL 800 mg
27617|NCT02284854|E4|Reported Event|ESL 800 mg + CBZ 400 mg Twice-daily|Group A + B ESL 800 mg + CBZ 400 mg twice-daily
27618|NCT02284854|E3|Reported Event|CBZ 400 mg Twice-daily|Group B CBZ 400 mg twice-daily
27619|NCT02284854|E2|Reported Event|CBZ 400 mg|Group B CBZ 400 mg
27620|NCT02284854|E1|Reported Event|CBZ 200 mg|Group B CBZ 200 mg
27621|NCT02284828|B1|Baseline|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
27622|NCT02284828|P1|Participant Flow|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
27623|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
27624|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
27625|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
27626|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
27627|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
27628|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
27629|NCT02284828|E4|Reported Event|BIA 2-093 1200 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
27630|NCT02284828|E3|Reported Event|BIA 2-093 800 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
27631|NCT02284828|E2|Reported Event|Placebo|Placebo, PLC
27632|NCT02284828|E1|Reported Event|BIA 2-093 900 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
27633|NCT02284555|B1|Baseline|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).
Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
27705|NCT02284165|E1|Reported Event|All Patients|Not applicable. This was a retrospective analysis of pre-existing data for acute ischemic stroke patients in the Get With the Guidelines registry with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry.
27635|NCT02284555|O1|Outcome|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).
Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
27636|NCT02284555|O1|Outcome|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).
Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
27637|NCT02284555|E1|Reported Event|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).
Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
27638|NCT02284516|B3|Baseline|Total|Total of all reporting groups
27639|NCT02284516|B2|Baseline|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
27640|NCT02284516|B1|Baseline|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
27641|NCT02284516|P2|Participant Flow|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
27642|NCT02284516|P1|Participant Flow|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
27643|NCT02284516|O2|Outcome|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
27644|NCT02284516|O1|Outcome|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
27645|NCT02284516|O2|Outcome|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
27646|NCT02284516|O1|Outcome|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
27647|NCT02284516|E2|Reported Event|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
27648|NCT02284516|E1|Reported Event|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
27649|NCT02284386|B1|Baseline|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
27650|NCT02284386|P1|Participant Flow|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
27651|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
27652|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
27653|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
27654|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
27655|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
27656|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
27657|NCT02284386|E1|Reported Event|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
27658|NCT02284347|B1|Baseline|NuVent™|"Revision patients treated with NuVent™
Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
27659|NCT02284347|P1|Participant Flow|NuVent™|"Revision patients treated with NuVent™
Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
27660|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™
Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
27661|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™
Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
27662|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™
Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
27663|NCT02284347|E1|Reported Event|NuVent™|"Revision patients treated with NuVent™
Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
27664|NCT02284243|B3|Baseline|Total|Total of all reporting groups
27665|NCT02284243|B2|Baseline|IN Placebo|"IN Placebo every 6 hours for 48 hours.
Intranasal Placebo"
27666|NCT02284243|B1|Baseline|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.
Intranasal Dexmedetomidine"
27667|NCT02284243|P2|Participant Flow|IN Placebo|"IN Placebo every 6 hours for 48 hours.
Intranasal Placebo"
27668|NCT02284243|P1|Participant Flow|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.
Intranasal Dexmedetomidine"
27669|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.
Intranasal Placebo"
27670|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.
Intranasal Dexmedetomidine"
27671|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.
Intranasal Placebo"
27672|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.
Intranasal Dexmedetomidine"
27673|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.
Intranasal Placebo"
27674|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.
Intranasal Dexmedetomidine"
27675|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.
Intranasal Placebo"
27676|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.
Intranasal Dexmedetomidine"
27677|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.
Intranasal Placebo"
27678|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.
Intranasal Dexmedetomidine"
27679|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.
Intranasal Placebo"
27680|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.
Intranasal Dexmedetomidine"
27681|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.
Intranasal Placebo"
27682|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.
Intranasal Dexmedetomidine"
27683|NCT02284243|E2|Reported Event|IN Placebo|"IN Placebo every 6 hours for 48 hours.
Intranasal Placebo"
27684|NCT02284243|E1|Reported Event|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.
Intranasal Dexmedetomidine"
27685|NCT02284165|B4|Baseline|Total|Total of all reporting groups
27686|NCT02284165|B3|Baseline|Discharged Home|Discharged from hospital to home with or without services
27687|NCT02284165|B2|Baseline|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
27688|NCT02284165|B1|Baseline|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
27689|NCT02284165|P3|Participant Flow|Discharged Home|Discharged from hospital to home with or without services
27690|NCT02284165|P2|Participant Flow|Skilled Nursing Facility (SNF)|Discharged from hospital to skilled nursing facility
27691|NCT02284165|P1|Participant Flow|Inpatient Rehab Facility (IRF)|Discharged from hospital to inpatient rehabilitation facility
27692|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
27693|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
27694|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
27695|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
27696|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
27697|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
27698|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
27699|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
27700|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
27701|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
27702|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
27703|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
27704|NCT02284165|O1|Outcome|All Patients|Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
27706|NCT02283840|B4|Baseline|Total|Total of all reporting groups
27904|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27709|NCT02283840|B1|Baseline|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27710|NCT02283840|P3|Participant Flow|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27711|NCT02283840|P2|Participant Flow|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27712|NCT02283840|P1|Participant Flow|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27713|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27714|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27715|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27716|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27717|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27718|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27719|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27720|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27721|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)
One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)
BIA 2-093"
27722|NCT02283840|E6|Reported Event|Reference 3|One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)
27723|NCT02283840|E5|Reported Event|Reference 2|One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)
27724|NCT02283840|E4|Reported Event|Reference 1|One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)
27725|NCT02283840|E3|Reported Event|Test 3|One Eslicarbazepine acetate (BIA 2-093) 800 mg To-Be-Marketed Formulation, TBM
27726|NCT02283840|E2|Reported Event|Test 2|One Eslicarbazepine acetate (BIA 2-093) 600 mg To-Be-Marketed Formulation, TBM
27727|NCT02283840|E1|Reported Event|Test 1|One Eslicarbazepine acetate (BIA 2-093) 400 mg To-Be-Marketed Formulation, TBM
27728|NCT02283827|B3|Baseline|Total|Total of all reporting groups
27729|NCT02283827|B2|Baseline|Group B BIA 2-093 + Phenytoin (PHT)|Pre-treatment: 100 mg PHT for 2 days; Treatment 1: 300 mg PHT 6 days; Treatment 2: 600 mg ESL + PHT 300 mg for 2 days; Treatment 3: 1200 mg ESL and PHT 300 mg for 17 days
27730|NCT02283827|B1|Baseline|Group A BIA 2-093 + Phenytoin (PHT)|Pre-treatment: 600 mg ESL, 2 days; Treatment 1: 1200 mg ESL 6 days Treatment 2: 1200 mg ESL and PHT 100 mg for 2 days Treatment 3: 1200 mg ESL and PHT 300 mg for17 days
27731|NCT02283827|P2|Participant Flow|Group B BIA 2-093 + Phenytoin (PHT)|"Day 1 to 2: Pre-treatment 2: PHT 100 mg Day 3 to 8: Treatment 2: PHT 300 mg Day 9 to 10: Treatment 2 + Pre-treatment 1: PHT 300 mg
+ ESL 600 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg"
27732|NCT02283827|P1|Participant Flow|Group A BIA 2-093 + Phenytoin (PHT)|Day 1 to 2: Pre-treatment 1: ESL 600 mg Day 3 to 8: Treatment 1:1200 mg ESL Day 9 to 10: Treatment 1 + Pre-treatment 2: 1200 mg ESL+ PHT 100 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg
27733|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
27734|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin (PHT)|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
27735|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
27736|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin (PHT)|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
27737|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
27738|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin|Phenytoin - PHT; BIA 2-093 - ESL, Eslicarbazepine
27739|NCT02283827|E7|Reported Event|BIA 2-093 600 mg + Phenytoin 300 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
27740|NCT02283827|E6|Reported Event|Phenytoin 300 mg|Phenytoin - PHT 300 mg
27741|NCT02283827|E5|Reported Event|Phenytoin 100 mg|Phenytoin - PHT 100 mg
27742|NCT02283827|E4|Reported Event|BIA 2-093 1200 mg + Phenytoin 300 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
27743|NCT02283827|E3|Reported Event|BIA 2-093 1200 mg + Phenytoin 100 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
27744|NCT02283827|E2|Reported Event|BIA 2-093 1200 mg|BIA 2-093 - ESL, Eslicarbazepine
27745|NCT02283827|E1|Reported Event|BIA 2-093 600 mg|BIA 2-093 - ESL, Eslicarbazepine
27746|NCT02283814|B3|Baseline|Total|Total of all reporting groups
27747|NCT02283814|B2|Baseline|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;
Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;
Treatment: 200 mg once daily dose of TPM administered for four consecutive days;
Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days
Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days
BIA 2-093
Topamax"
27748|NCT02283814|B1|Baseline|Group A BIA 2-093 + Topamax|"Group A
Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;
Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days
Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days
Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days
Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days
BIA 2-093
Topamax"
27749|NCT02283814|P2|Participant Flow|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;
Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;
Treatment: 200 mg once daily dose of TPM administered for four consecutive days;
Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days
Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days
BIA 2-093
Topamax"
27750|NCT02283814|P1|Participant Flow|Group A BIA 2-093 + Topamax|"Group A
Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;
Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days
Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days
Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days
Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days
BIA 2-093
Topamax"
27751|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
27752|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
27753|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
27754|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
27755|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
27756|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
27757|NCT02283814|E2|Reported Event|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;
Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;
Treatment: 200 mg once daily dose of TPM administered for four consecutive days;
Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days
Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days
BIA 2-093
Topamax"
27758|NCT02283814|E1|Reported Event|Group A BIA 2-093 + Topamax|"Group A
Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;
Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days
Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days
Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days
Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days
BIA 2-093
Topamax"
27759|NCT02283788|B5|Baseline|Total|Total of all reporting groups
27760|NCT02283788|B4|Baseline|Treatment Sequence DCBA|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days
BIA 2-093
Moxifloxacin
Placebo"
27761|NCT02283788|B3|Baseline|Treatment Sequence CADB|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days
BIA 2-093
Moxifloxacin
Placebo"
27762|NCT02283788|B2|Baseline|Treatment Sequence BDAC|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days
BIA 2-093
Moxifloxacin
Placebo"
27763|NCT02283788|B1|Baseline|Treatment Sequence ABCD|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days
BIA 2-093
Moxifloxacin
Placebo"
27764|NCT02283788|P4|Participant Flow|Group D|Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
27765|NCT02283788|P3|Participant Flow|Group C|Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
27766|NCT02283788|P2|Participant Flow|Group B|Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
27767|NCT02283788|P1|Participant Flow|Group A|Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
27768|NCT02283788|O4|Outcome|Placebo|Placebo, PLC
27769|NCT02283788|O3|Outcome|Moxifloxacin 400 mg|brand names Avelox, Avalox, and Avelon
27770|NCT02283788|O2|Outcome|BIA 2-093 2400 mg|ESL, Eslicarbazepine 1200 mg
27771|NCT02283788|O1|Outcome|BIA 2-093 1200 mg|ESL, Eslicarbazepine 1200 mg
27772|NCT02283788|E4|Reported Event|Group D|Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
27773|NCT02283788|E3|Reported Event|Group C|Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
27774|NCT02283788|E2|Reported Event|Group B|Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
27775|NCT02283788|E1|Reported Event|Group A|Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
29890|NCT02256891|O1|Outcome|Double Row|"Double Row
Double Row"
27837|NCT02282982|B1|Baseline|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27838|NCT02282982|P1|Participant Flow|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27841|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27842|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27843|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27844|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27845|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27846|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27847|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27848|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27849|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27850|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27851|NCT02282982|E1|Reported Event|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
27852|NCT02282813|B4|Baseline|Total|Total of all reporting groups
27853|NCT02282813|B3|Baseline|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
27854|NCT02282813|B2|Baseline|CTAP101 Capsules (Monotherapy; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
27855|NCT02282813|B1|Baseline|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
27856|NCT02282813|P3|Participant Flow|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
27857|NCT02282813|P2|Participant Flow|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
27858|NCT02282813|P1|Participant Flow|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
27859|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
27860|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
27861|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
27862|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
27863|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
27864|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
27865|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
27866|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
27867|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
29148|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
27868|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
27869|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
27963|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine
S-licarbazepine: capsules containing 225 mg"
27870|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
27871|NCT02282813|E3|Reported Event|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
27872|NCT02282813|E2|Reported Event|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
27873|NCT02282813|E1|Reported Event|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
27874|NCT02282631|B3|Baseline|Total|Total of all reporting groups
27875|NCT02282631|B2|Baseline|Intervention School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw. Every trip to school reported by the parent as being active (walking/cycling) corresponds to one ticket entered into the draw. In total, one child can have up to five tickets entered into one draw."
27876|NCT02282631|B1|Baseline|Control School|School with no intervention; ongoing advice on active school travel.
27877|NCT02282631|P2|Participant Flow|Intervention Group School|School with intervention (incentive scheme)
27878|NCT02282631|P1|Participant Flow|Control Group School|School with no intervention (incentive scheme)
27879|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27880|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27881|NCT02282631|O2|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27882|NCT02282631|O1|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27883|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
27884|NCT02282631|O1|Outcome|ATS Trips|active trips to school
27885|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
27886|NCT02282631|O1|Outcome|ATS Trips|active trips to school
27887|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
27888|NCT02282631|O1|Outcome|ATS Trips|active trips to school
27889|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
27890|NCT02282631|O1|Outcome|ATS Trips|active trips to school
27891|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27892|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27893|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27894|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27895|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27896|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27897|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27898|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27899|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27900|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27901|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27902|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27903|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27905|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27906|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27961|NCT02281591|P1|Participant Flow|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)
BIA 2-093: Tablets containing 900 mg"
27907|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27908|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27909|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.
Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
27910|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
27911|NCT02282631|O1|Outcome|Schools Who Took Part|Schools who took part in this study (two)
27912|NCT02282631|O1|Outcome|Schools Contacted|Primary schools (or equivalent) located in the North East approached in this study
27913|NCT02282631|E2|Reported Event|Intervention Group School|School with intervention (incentive scheme)
27914|NCT02282631|E1|Reported Event|Control Group School|School with no intervention (incentive scheme)
27915|NCT02282605|B4|Baseline|Total|Total of all reporting groups
27916|NCT02282605|B3|Baseline|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths"
27917|NCT02282605|B2|Baseline|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27918|NCT02282605|B1|Baseline|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27919|NCT02282605|P3|Participant Flow|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths"
27920|NCT02282605|P2|Participant Flow|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27921|NCT02282605|P1|Participant Flow|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27922|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths"
27923|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27924|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27925|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths"
27926|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27927|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27928|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths"
27929|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27930|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27931|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths"
27962|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine
R-licarbazepine: capsules containing 225 mg"
27932|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27933|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27934|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths"
27935|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27936|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27937|NCT02282605|E3|Reported Event|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths"
27938|NCT02282605|E2|Reported Event|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27939|NCT02282605|E1|Reported Event|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths"
27940|NCT02282527|B3|Baseline|Total|Total of all reporting groups
27941|NCT02282527|B2|Baseline|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI
Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions
Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
27942|NCT02282527|B1|Baseline|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C
Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions
Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
27943|NCT02282527|P2|Participant Flow|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI
Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions
Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
27944|NCT02282527|P1|Participant Flow|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C
Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions
Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
27945|NCT02282527|O2|Outcome|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI
Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions
Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
27946|NCT02282527|O1|Outcome|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C
Liquid Alpha₁-PI: Liquid Alpha1-PI, 60 mg/kg, 8 weekly intravenous infusions
Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
27947|NCT02282527|O2|Outcome|Prolastin-C|"Subjects treated with Prolastin-C in each treatment sequence
Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
27948|NCT02282527|O1|Outcome|Liquid Alpha₁-PI|"Subjects treated with Liquid Alpha₁-PI in each treatment sequence
Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
27949|NCT02282527|O2|Outcome|Prolastin-C|"Subjects treated with Prolastin-C in each treatment sequence
Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
27950|NCT02282527|O1|Outcome|Liquid Alpha₁-PI|"Subjects treated with Liquid Alpha₁-PI in each treatment sequence
Liquid Alpha₁-PI: Liquid Alpha1-PI, 60 mg/kg, 8 weekly intravenous infusions"
27951|NCT02282527|E2|Reported Event|Prolastin-C|Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions
27952|NCT02282527|E1|Reported Event|Liquid Alpha₁-PI|Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions
27953|NCT02281591|B5|Baseline|Total|Total of all reporting groups
27954|NCT02281591|B4|Baseline|R-licarbazepine|"450 mg of Rlicarbazepine
R-licarbazepine: capsules containing 225 mg"
27955|NCT02281591|B3|Baseline|S-licarbazepine|"450 mg of S-licarbazepine
S-licarbazepine: capsules containing 225 mg"
27956|NCT02281591|B2|Baseline|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine
S-licarbazepine: capsules containing 225 mg
R-licarbazepine: capsules containing 225 mg"
27957|NCT02281591|B1|Baseline|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)
BIA 2-093: Tablets containing 900 mg"
27958|NCT02281591|P4|Participant Flow|R-licarbazepine|"450 mg of Rlicarbazepine
R-licarbazepine: capsules containing 225 mg"
27959|NCT02281591|P3|Participant Flow|S-licarbazepine|"450 mg of S-licarbazepine
S-licarbazepine: capsules containing 225 mg"
29476|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure
VTI= Valveless recirculating insufflation"
27960|NCT02281591|P2|Participant Flow|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine
S-licarbazepine: capsules containing 225 mg
R-licarbazepine: capsules containing 225 mg"
43953|NCT02135432|O2|Outcome|Placebo|"matching placebo
Placebo"
27964|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine
S-licarbazepine: capsules containing 225 mg
R-licarbazepine: capsules containing 225 mg"
27965|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)
BIA 2-093: Tablets containing 900 mg"
27966|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine
R-licarbazepine: capsules containing 225 mg"
27967|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine
S-licarbazepine: capsules containing 225 mg"
27968|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine
S-licarbazepine: capsules containing 225 mg
R-licarbazepine: capsules containing 225 mg"
27969|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)
BIA 2-093: Tablets containing 900 mg"
27970|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine
R-licarbazepine: capsules containing 225 mg"
27971|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine
S-licarbazepine: capsules containing 225 mg"
27972|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine
S-licarbazepine: capsules containing 225 mg
R-licarbazepine: capsules containing 225 mg"
27973|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)
BIA 2-093: Tablets containing 900 mg"
27974|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine
R-licarbazepine: capsules containing 225 mg"
27975|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine
S-licarbazepine: capsules containing 225 mg"
27976|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine
S-licarbazepine: capsules containing 225 mg
R-licarbazepine: capsules containing 225 mg"
27977|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)
BIA 2-093: Tablets containing 900 mg"
27978|NCT02281591|E4|Reported Event|R-licarbazepine|"450 mg of Rlicarbazepine
R-licarbazepine: capsules containing 225 mg"
27979|NCT02281591|E3|Reported Event|S-licarbazepine|"450 mg of S-licarbazepine
S-licarbazepine: capsules containing 225 mg"
27980|NCT02281591|E2|Reported Event|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine
S-licarbazepine: capsules containing 225 mg
R-licarbazepine: capsules containing 225 mg"
27981|NCT02281591|E1|Reported Event|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)
BIA 2-093: Tablets containing 900 mg"
27982|NCT02281526|B3|Baseline|Total|Total of all reporting groups
27983|NCT02281526|B2|Baseline|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093"
27984|NCT02281526|B1|Baseline|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093"
27985|NCT02281526|P2|Participant Flow|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093"
27986|NCT02281526|P1|Participant Flow|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093"
27987|NCT02281526|O2|Outcome|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093"
27988|NCT02281526|O1|Outcome|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093"
27989|NCT02281526|O2|Outcome|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093"
27990|NCT02281526|O1|Outcome|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093"
27991|NCT02281526|E2|Reported Event|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093"
27992|NCT02281526|E1|Reported Event|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093"
27993|NCT02281448|B3|Baseline|Total|Total of all reporting groups
27994|NCT02281448|B2|Baseline|Treatment Sequence B|"oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days
BIA 2-093
Contraceptives, Oral, Combined"
27995|NCT02281448|B1|Baseline|Treatment Sequence A|"oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive
BIA 2-093
Contraceptives, Oral, Combined"
27996|NCT02281448|P2|Participant Flow|Treatment Sequence B|"oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days
BIA 2-093
Contraceptives, Oral, Combined"
27997|NCT02281448|P1|Participant Flow|Treatment Sequence A|"oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive
BIA 2-093
Contraceptives, Oral, Combined"
27998|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
27999|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
28000|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
28001|NCT02281448|O1|Outcome|Cmax (BIA 2-194)|Mean trough (pre-dose) plasma concentrations of BIA 2-194 on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
28002|NCT02281448|E2|Reported Event|Microginon®|Microginon® (n=18)
28003|NCT02281448|E1|Reported Event|Eslicarbazepine Acetate 1200 mg + Microginon®|Eslicarbazepine acetate 1200 mg + Microginon® (n=19)
28004|NCT02281422|B6|Baseline|Total|Total of all reporting groups
29901|NCT02256891|E2|Reported Event|Double Row With PRFM|"Double Row with PRFM
PRFM
Double Row"
28005|NCT02281422|B5|Baseline|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093"
28006|NCT02281422|B4|Baseline|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)
BIA 2-093"
28007|NCT02281422|B3|Baseline|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093"
28008|NCT02281422|B2|Baseline|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093"
28009|NCT02281422|B1|Baseline|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)
BIA 2-093"
28010|NCT02281422|P5|Participant Flow|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093"
28011|NCT02281422|P4|Participant Flow|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)
BIA 2-093"
28012|NCT02281422|P3|Participant Flow|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093"
28013|NCT02281422|P2|Participant Flow|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093"
28014|NCT02281422|P1|Participant Flow|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)
BIA 2-093"
28015|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093"
28016|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)
BIA 2-093"
28017|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093"
28018|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093"
28019|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)
BIA 2-093"
28020|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093"
28021|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)
BIA 2-093"
28022|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093"
28023|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093"
28024|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)
BIA 2-093"
28025|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093"
28026|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)
BIA 2-093"
28027|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093"
28028|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093"
28029|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)
BIA 2-093"
28030|NCT02281422|E5|Reported Event|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093"
28031|NCT02281422|E4|Reported Event|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)
BIA 2-093"
28032|NCT02281422|E3|Reported Event|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093"
28033|NCT02281422|E2|Reported Event|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093"
28034|NCT02281422|E1|Reported Event|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)
BIA 2-093"
28035|NCT02281318|B3|Baseline|Total|Total of all reporting groups
28036|NCT02281318|B2|Baseline|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28037|NCT02281318|B1|Baseline|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28038|NCT02281318|P2|Participant Flow|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28039|NCT02281318|P1|Participant Flow|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28040|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28041|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28042|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28043|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
29477|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
28044|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28045|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28046|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28047|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28048|NCT02281318|E2|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28049|NCT02281318|E1|Reported Event|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
28050|NCT02281136|B1|Baseline|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28051|NCT02281136|P1|Participant Flow|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28052|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28053|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28054|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28055|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28056|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28057|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28058|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28059|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28060|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28061|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28062|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28063|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28175|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28064|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28258|NCT02278614|O2|Outcome|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops
Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
28065|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28066|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28067|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28068|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28069|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28070|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28071|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28072|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28073|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28074|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28075|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28076|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28077|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28078|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28079|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28080|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28081|NCT02281136|E1|Reported Event|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
28082|NCT02280811|B6|Baseline|Total|Total of all reporting groups
28139|NCT02280655|E2|Reported Event|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.
Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
40433|NCT02158273|B2|Baseline|Placebo|Matched Placebo
28140|NCT02280655|E1|Reported Event|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.
Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
28083|NCT02280811|B5|Baseline|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28084|NCT02280811|B4|Baseline|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28085|NCT02280811|B3|Baseline|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28086|NCT02280811|B2|Baseline|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28087|NCT02280811|B1|Baseline|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28088|NCT02280811|P5|Participant Flow|HPV-16 E6 mTCR PBL MTD + HD IL-2|"This is the phase 2 arm that was treated at the MTD determined in the phase 1 portion.
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28089|NCT02280811|P4|Participant Flow|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28090|NCT02280811|P3|Participant Flow|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28091|NCT02280811|P2|Participant Flow|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28092|NCT02280811|P1|Participant Flow|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28256|NCT02278614|P2|Participant Flow|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops
Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
28093|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28094|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28095|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28096|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28097|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28098|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28099|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28100|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28101|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28102|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28173|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28103|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28104|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28105|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28106|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28107|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28108|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28109|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28110|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28111|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28112|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28174|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28113|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28114|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28115|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28116|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28117|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28118|NCT02280811|O5|Outcome|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28119|NCT02280811|O4|Outcome|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28120|NCT02280811|O3|Outcome|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28121|NCT02280811|O2|Outcome|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28122|NCT02280811|O1|Outcome|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28123|NCT02280811|O1|Outcome|All Treated Subjects|All treated subjects who received at least one dose of human papilloma virus (HPV)-16 E6 monoclonal T cell receptor (mTCR) peripheral blood lymphocytes (PBL) 1x10^9, 1x10^10,1x10^11, >1x10^11 up to 2x10^11 + high-dose (HD) interleukin 2 (IL-2) were included.
28124|NCT02280811|E6|Reported Event|HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28125|NCT02280811|E5|Reported Event|HPV-16 E6 mTCR PBL MTD + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28126|NCT02280811|E4|Reported Event|HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28127|NCT02280811|E3|Reported Event|HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28128|NCT02280811|E2|Reported Event|HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28129|NCT02280811|E1|Reported Event|HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2|"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin
Fludarabine: Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
28130|NCT02280655|B3|Baseline|Total|Total of all reporting groups
28131|NCT02280655|B2|Baseline|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.
Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
28132|NCT02280655|B1|Baseline|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.
Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
28133|NCT02280655|P2|Participant Flow|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.
Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
28134|NCT02280655|P1|Participant Flow|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.
Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
28135|NCT02280655|O2|Outcome|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.
Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
28136|NCT02280655|O1|Outcome|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.
Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
28137|NCT02280655|O2|Outcome|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.
Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
28138|NCT02280655|O1|Outcome|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.
Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
41122|NCT02153489|O2|Outcome|Placebo|Placebo BID
28141|NCT02280499|B1|Baseline|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
28142|NCT02280499|P1|Participant Flow|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
28143|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
28144|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
28145|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
28146|NCT02280499|E1|Reported Event|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
28147|NCT02280473|B3|Baseline|Total|Total of all reporting groups
28148|NCT02280473|B2|Baseline|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28149|NCT02280473|B1|Baseline|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28150|NCT02280473|P2|Participant Flow|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28151|NCT02280473|P1|Participant Flow|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28152|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28153|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28154|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28155|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28156|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28157|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28158|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28159|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28160|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28161|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28162|NCT02280473|E2|Reported Event|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28163|NCT02280473|E1|Reported Event|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
28164|NCT02280187|B1|Baseline|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28165|NCT02280187|P1|Participant Flow|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28166|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28167|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28168|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28169|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28170|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28171|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28172|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
29478|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure
VTI= Valveless recirculating insufflation"
28176|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
29902|NCT02256891|E1|Reported Event|Double Row|"Double Row
Double Row"
28177|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28178|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28179|NCT02280187|E1|Reported Event|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
28180|NCT02280122|B3|Baseline|Total|Total of all reporting groups
28181|NCT02280122|B2|Baseline|Periodontally Healthy|"PPD ≤ 3 mm
PAL-V ≤ 2 mm at < 30% of sites
BOP < 20%
No radiographically detectable bone loss: distance cemento-enamel junction to provided
no Intervention but aMMP-8 test
no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
28182|NCT02280122|B1|Baseline|Generalised Moderate to Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm
Attachment loss (PAL-V) ≥ 3 mm > 30% of sites
no Intervention provided
no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
28183|NCT02280122|P3|Participant Flow|Periodontally Healthy|"PPD ≤ 3 mm
PAL-V ≤ 2 mm at < 30% of sites
BOP < 20%
No radiographically detectable bone loss: distance cemento-enamel junction to provided
no Intervention but aMMP-8 test
no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
28184|NCT02280122|P2|Participant Flow|Severe Chronic Periodontitis|"Sites with probing PPD ≥ 3.5 mm
PAL-V ≥ 5 mm > 30% of sites
no Intervention provided
no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
28185|NCT02280122|P1|Participant Flow|Moderate Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm
Attachment loss (PAL-V) 3-4 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites
no Intervention provided
no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
28186|NCT02280122|O2|Outcome|Specificity: Periodontally Healthy|"PPD ≤ 3 mm
PAL-V ≤ 2 mm at < 30% of sites
BOP < 20%
No radiographically detectable bone loss: distance cemento-enamel junction to provided
no Intervention but aMMP-8 test
no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
28187|NCT02280122|O1|Outcome|Sensitivity: Generalised Moderate/Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm
Attachment loss (PAL-V) ≥ 3 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites
no Intervention provided
no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
28188|NCT02280122|E2|Reported Event|Periodontally Healthy|"PPD ≤ 3 mm
PAL-V ≤ 2 mm at < 30% of sites
BOP < 20%
No radiographically detectable bone loss: distance cemento-enamel junction to provided
no Intervention but aMMP-8 test
no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
28189|NCT02280122|E1|Reported Event|Generalized Moderate to Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm
Attachment loss (PAL-V) 3-4 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites
no Intervention provided
no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
28190|NCT02279667|B4|Baseline|Total|Total of all reporting groups
28191|NCT02279667|B3|Baseline|Group C|"st period - Four 200 mg tablets
nd period - One 800 mg tablet
rd period - 16 mL oral suspension 50 mg/mL"
28192|NCT02279667|B2|Baseline|Group B|"st period - One 800 mg tablet
nd period - 16 mL oral suspension 50 mg/mL
rd period - Four 200 mg tablets"
28193|NCT02279667|B1|Baseline|Group A|"st period - 16 mL oral suspension 50 mg/mL
nd period - Four 200 mg tablets
rd period - One 800 mg tablet"
28194|NCT02279667|P3|Participant Flow|Group C|"st period - Four 200 mg tablets
nd period - One 800 mg tablet
rd period - 16 mL oral suspension 50 mg/mL"
28195|NCT02279667|P2|Participant Flow|Group B|"st period - One 800 mg tablet
nd period - 16 mL oral suspension 50 mg/mL
rd period - Four 200 mg tablets"
28196|NCT02279667|P1|Participant Flow|Group A|"st period - 16 mL oral suspension 50 mg/mL
nd period - Four 200 mg tablets
rd period - One 800 mg tablet"
28197|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
28198|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
28199|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
28200|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
28201|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
28202|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
28203|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
28204|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
28205|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
28206|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
28207|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
28208|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
28209|NCT02279667|E4|Reported Event|Follow-up|Follow-up.
28210|NCT02279667|E3|Reported Event|BIA 2-093 One 800 mg Tablet|BIA 2-093, ESL, Eslicarbazepine acetate 800 mg tablet
28211|NCT02279667|E2|Reported Event|BIA 2-093 - Four 200 mg Tablets|BIA 2-093, ESL, Eslicarbazepine acetate 200 mg tablets
28212|NCT02279667|E1|Reported Event|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093, ESL, Eslicarbazepine acetate oral suspension 50 mg/mL
28257|NCT02278614|P1|Participant Flow|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
28213|NCT02279420|B1|Baseline|Essential Study Sham Cross-over|Device: g-Cath EZ™ Suture Anchor Delivery Catheter This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
28214|NCT02279420|P1|Participant Flow|Essential Study Sham Cross-over|Eligible sham subjects from primary study
28215|NCT02279420|O1|Outcome|Essential Study Sham Cross-over|This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
28216|NCT02279420|E1|Reported Event|Essential Study Sham Cross-over|This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
28217|NCT02279407|B5|Baseline|Total|Total of all reporting groups
28218|NCT02279407|B4|Baseline|Placebo|Placebo to Epanova and placebo to Dapagliflozin
28219|NCT02279407|B3|Baseline|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
28220|NCT02279407|B2|Baseline|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
28221|NCT02279407|B1|Baseline|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
28222|NCT02279407|P4|Participant Flow|Placebo|Placebo to Epanova and placebo to Dapagliflozin
28223|NCT02279407|P3|Participant Flow|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
28224|NCT02279407|P2|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
28225|NCT02279407|P1|Participant Flow|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
28226|NCT02279407|O3|Outcome|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
28227|NCT02279407|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
28228|NCT02279407|O1|Outcome|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
28229|NCT02279407|O2|Outcome|Placebo|Placebo to Epanova and placebo to Dapagliflozin
28230|NCT02279407|O1|Outcome|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
28231|NCT02279407|E4|Reported Event|Placebo|Placebo to Epanova and placebo to Dapagliflozin
28232|NCT02279407|E3|Reported Event|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
28233|NCT02279407|E2|Reported Event|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
28234|NCT02279407|E1|Reported Event|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
28235|NCT02279082|B1|Baseline|DFN-02 (Single Arm, Open Label)|"Active DFN-02
DFN-02: Active Experimental Drug"
28236|NCT02279082|P1|Participant Flow|DFN-02|"Active DFN-02 (Nasal Sumatriptan 10mg)
DFN-02: Active Experimental Drug"
28237|NCT02279082|O1|Outcome|DFN-02|"Active DFN-02
DFN-02: Active Experimental Drug"
28238|NCT02279082|E1|Reported Event|DFN-02 (Single Arm, Open Label)|"Active DFN-02
DFN-02: Active Experimental Drug"
28239|NCT02278783|B1|Baseline|All Patients|
28240|NCT02278783|P1|Participant Flow|All Patients|
28241|NCT02278783|O1|Outcome|All Patients|
28242|NCT02278783|O1|Outcome|All Patients|
28243|NCT02278783|O1|Outcome|All Patients|
28244|NCT02278783|O1|Outcome|All Patients|
28245|NCT02278783|E1|Reported Event|All Patients|
28246|NCT02278640|B1|Baseline|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy
Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
28247|NCT02278640|P1|Participant Flow|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy
Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
28248|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy
Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
28249|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy
Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
28250|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy
Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
28251|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy
Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
28252|NCT02278640|E1|Reported Event|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy
Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
28253|NCT02278614|B3|Baseline|Total|Total of all reporting groups
28254|NCT02278614|B2|Baseline|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops
Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
28255|NCT02278614|B1|Baseline|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
28259|NCT02278614|O1|Outcome|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
28260|NCT02278614|E2|Reported Event|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops
Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
28261|NCT02278614|E1|Reported Event|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
28262|NCT02278484|B1|Baseline|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
28263|NCT02278484|P1|Participant Flow|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
28264|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
28265|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
28266|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
28267|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation Using XprESS and PathAssist Devices.
28268|NCT02278484|E1|Reported Event|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
28269|NCT02278146|B3|Baseline|Total|Total of all reporting groups
28270|NCT02278146|B2|Baseline|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28271|NCT02278146|B1|Baseline|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28272|NCT02278146|P2|Participant Flow|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28273|NCT02278146|P1|Participant Flow|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28274|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28275|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28276|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28277|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28278|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28279|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28280|NCT02278146|E2|Reported Event|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28281|NCT02278146|E1|Reported Event|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence"
28282|NCT02277691|B1|Baseline|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
28283|NCT02277691|P1|Participant Flow|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
28284|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
28285|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
28339|NCT02277093|P1|Participant Flow|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
29479|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
28312|NCT02277249|O2|Outcome|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
28286|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
28287|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
28288|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
28289|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
28290|NCT02277691|O1|Outcome|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
28291|NCT02277691|E1|Reported Event|TAK-536TCH|"For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast."
28292|NCT02277626|B1|Baseline|Total Number of Participants|
28293|NCT02277626|P2|Participant Flow|ElectroFlo First Then Vest|"Experimental: ElectroFlo 5000, then VEST 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of ElectroFlo 5000 at one visit and during the second visit, they crossed-over to the Vest.
Electro Flo 5000: Airway clearance device"
28294|NCT02277626|P1|Participant Flow|Vest First Then ElectroFlo|"Experimental: VEST, then ElectroFlo 5000 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of Vest at one visit and during the second visit, they crossed-over to the ElectroFlo 5000.
EnCourage Vest System: Airway Clearance Device"
28295|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm
Electro Flo 5000: Airway clearance device"
28296|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm
EnCourage Vest System: Airway Clearance Device"
28297|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm
Electro Flo 5000: Airway clearance device"
28298|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm
EnCourage Vest System: Airway Clearance Device"
28299|NCT02277626|O2|Outcome|Vest Arm|"Vest arm
Incourage Vest System: Airway Clearance Device"
28300|NCT02277626|O1|Outcome|ElectroFlo Arm|"ElectroFlo Arm
Electro Flo 5000: Airway clearance device"
28301|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm
Electro Flo 5000: Airway clearance device"
28302|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm
Incourage Vest System: Airway Clearance Device"
28303|NCT02277626|O2|Outcome|Elecflo Arm|"Elecflo Arm
Electro Flo 5000: Airway clearance device"
28304|NCT02277626|O1|Outcome|Vest|"VEST Arm
Incourage Vest System: Airway Clearance Device"
28305|NCT02277626|E2|Reported Event|ElectroFlo Arm|"ElectroFlo Arm
Electro Flo 5000: Airway clearance device"
28306|NCT02277626|E1|Reported Event|Vest Arm|"Vest arm
Incourage Vest System: Airway Clearance Device"
28307|NCT02277249|B3|Baseline|Total|Total of all reporting groups
28308|NCT02277249|B2|Baseline|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
28309|NCT02277249|B1|Baseline|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
28310|NCT02277249|P2|Participant Flow|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
28311|NCT02277249|P1|Participant Flow|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
28340|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
41123|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
28313|NCT02277249|O1|Outcome|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
28314|NCT02277249|E2|Reported Event|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
28315|NCT02277249|E1|Reported Event|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
28316|NCT02277119|B4|Baseline|Total|Total of all reporting groups
28317|NCT02277119|B3|Baseline|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28318|NCT02277119|B2|Baseline|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28319|NCT02277119|B1|Baseline|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28320|NCT02277119|P3|Participant Flow|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28321|NCT02277119|P2|Participant Flow|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28322|NCT02277119|P1|Participant Flow|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28323|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28324|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28325|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28326|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28327|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28328|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28329|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28330|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28331|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28332|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28333|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28334|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28335|NCT02277119|E3|Reported Event|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28336|NCT02277119|E2|Reported Event|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28337|NCT02277119|E1|Reported Event|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes"
28338|NCT02277093|B1|Baseline|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
28341|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
28470|NCT02275767|B4|Baseline|Total|Total of all reporting groups
43959|NCT02135432|E2|Reported Event|Placebo|"matching placebo
Placebo"
28342|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
28343|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
28344|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
28345|NCT02277093|E1|Reported Event|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
28346|NCT02276560|B4|Baseline|Total|Total of all reporting groups
28347|NCT02276560|B3|Baseline|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4
Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
28348|NCT02276560|B2|Baseline|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2
Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
28349|NCT02276560|B1|Baseline|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care
Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
28350|NCT02276560|P3|Participant Flow|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4
Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
28351|NCT02276560|P2|Participant Flow|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2
Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
28352|NCT02276560|P1|Participant Flow|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care
Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
28353|NCT02276560|O3|Outcome|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4
Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
28354|NCT02276560|O2|Outcome|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2
Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
28355|NCT02276560|O1|Outcome|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care
Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
28356|NCT02276560|E3|Reported Event|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4
Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
28357|NCT02276560|E2|Reported Event|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2
Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
28358|NCT02276560|E1|Reported Event|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care
Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
28359|NCT02276274|B3|Baseline|Total|Total of all reporting groups
28360|NCT02276274|B2|Baseline|SYR-322-MET Fed Followed by SYR-322-MET Fasted|A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
28361|NCT02276274|B1|Baseline|SYR-322-MET Fasted Followed by SYR-322-MET Fed|A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
28362|NCT02276274|P2|Participant Flow|SYR-322-MET Fed Followed by SYR-322-MET Fasted|A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
28363|NCT02276274|P1|Participant Flow|SYR-322-MET Fasted Followed by SYR-322-MET Fed|A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
28364|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
30703|NCT02248818|P7|Participant Flow|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
28365|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28366|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28367|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28368|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28369|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28370|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28371|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28372|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28373|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28374|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28375|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28376|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28377|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28378|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28379|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28380|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28381|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28382|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28383|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28384|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28385|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28386|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28387|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28388|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28389|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28390|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28391|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28392|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28393|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28394|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28395|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28396|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28397|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28398|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28691|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
28399|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28400|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28401|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28402|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28403|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28404|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28405|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28406|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28407|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28408|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28409|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28410|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28411|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28412|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28413|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28414|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28415|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28416|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28417|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28418|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28419|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28420|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28421|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28422|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28423|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28424|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28425|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28426|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28427|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28428|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28429|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28430|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28431|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28432|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28433|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28692|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
28434|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28435|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28436|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28437|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28438|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28439|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28440|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28441|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28442|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28443|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28444|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28445|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28446|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28447|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28448|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28449|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28450|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28451|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28452|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28453|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28454|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28455|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28456|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28457|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28458|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28459|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28460|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28461|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28462|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28463|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28464|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28465|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28466|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28467|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28468|NCT02276274|E2|Reported Event|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
28693|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
28469|NCT02276274|E1|Reported Event|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
28471|NCT02275767|B3|Baseline|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
28472|NCT02275767|B2|Baseline|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
28473|NCT02275767|B1|Baseline|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
28474|NCT02275767|P3|Participant Flow|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
28475|NCT02275767|P2|Participant Flow|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
28476|NCT02275767|P1|Participant Flow|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
28477|NCT02275767|O3|Outcome|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
28478|NCT02275767|O2|Outcome|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
28479|NCT02275767|O1|Outcome|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
28480|NCT02275767|O3|Outcome|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
28481|NCT02275767|O2|Outcome|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
28482|NCT02275767|O1|Outcome|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
28483|NCT02275767|E3|Reported Event|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
28484|NCT02275767|E2|Reported Event|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
28485|NCT02275767|E1|Reported Event|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
28486|NCT02275611|B5|Baseline|Total|Total of all reporting groups
28487|NCT02275611|B4|Baseline|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
28488|NCT02275611|B3|Baseline|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
28489|NCT02275611|B2|Baseline|Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal placebo spray. Inpatient Withdrawal
28490|NCT02275611|B1|Baseline|Intranasal Oxytocin Spray (Syntocinon)|Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal oxytocin spray. Inpatient Withdrawal
28491|NCT02275611|P4|Participant Flow|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
28492|NCT02275611|P3|Participant Flow|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
28493|NCT02275611|P2|Participant Flow|Placebo Comparator: Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks Inpatient Withdrawal
28494|NCT02275611|P1|Participant Flow|Active Comparator:Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks.
Inpatient Withdrawal"
28495|NCT02275611|O2|Outcome|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
28496|NCT02275611|O1|Outcome|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
28497|NCT02275611|O2|Outcome|Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient
28498|NCT02275611|O1|Outcome|Intranasal Oxytocin Spray (Syntocinon Spray)|Syntocinon Spray 3-4 doses daily inpatient
28499|NCT02275611|O2|Outcome|Intranasal Placebo Spray|"Placebo spray 3-4 doses daily inpatient
intranasal oxytocin spray: Administration of oxytocin in a nasal spray
Intranasal Placebo Spray: Intranasal Placebo Spray"
28500|NCT02275611|O1|Outcome|Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient
intranasal oxytocin spray: Administration of oxytocin in a nasal spray"
28501|NCT02275611|E4|Reported Event|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
28502|NCT02275611|E3|Reported Event|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
28503|NCT02275611|E2|Reported Event|Intranasal Placebo Spray|"Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks
intranasal oxytocin spray: Administration of oxytocin in a nasal spray
Intranasal Placebo Spray: Intranasal Placebo Spray"
28504|NCT02275611|E1|Reported Event|Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks
intranasal oxytocin spray: Administration of oxytocin in a nasal spray"
28505|NCT02275546|B1|Baseline|All Randomized Participants|
28506|NCT02275546|P2|Participant Flow|No Applicator (Manual)→Applicator|In Treatment Period 1, participants manually inserted the vaginal ring using their fingers only. In Treatment Period 2, participants used the applicator to insert the vaginal ring.
28507|NCT02275546|P1|Participant Flow|Applicator→No Applicator (Manual)|In Treatment Period 1, participants used the applicator to insert the vaginal ring. In Treatment Period 2 participants manually inserted the vaginal ring using their fingers only.
28508|NCT02275546|O2|Outcome|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
28509|NCT02275546|O1|Outcome|Applicator|Participants used the applicator to insert the vaginal ring.
28510|NCT02275546|O2|Outcome|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
28511|NCT02275546|O1|Outcome|Applicator|Participants used the applicator to insert the vaginal ring.
28512|NCT02275546|E2|Reported Event|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
28513|NCT02275546|E1|Reported Event|Applicator|Participants used the applicator to insert the vaginal ring.
28514|NCT02275364|B1|Baseline|Overall|Participants were randomized to receive either Marketed Nasal Strip or Placebo Nasal Strip (to be applied for up to two hours in either of the first two scans only). During the third scanning session, Marketed Nasal Strip was applied for approximately 20 minutes after administration of a Marketed Decongestant.
28515|NCT02275364|P2|Participant Flow|Sequence 2|In the sequence 1 of the crossover part of the study, participants were randomized to receive marketed strip first (period 1) followed by marketed strip (period 2). The marketed strip was applied for up to two hours for the first scanning sessions, and then removed and the placebo strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3
28516|NCT02275364|P1|Participant Flow|Sequence 1|In the sequence 1 of the crossover part of the study, participants were randomized to receive placebo strip first (period 1) followed by marketed strip (period 2). The placebo strip was applied for up to two hours for the first scanning sessions, and then removed and the marketed strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3
28517|NCT02275364|O1|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
28518|NCT02275364|O2|Outcome|Placebo Strip|Placebo nasal strip to be applied for up to two hours in either of the first two scans only.
28519|NCT02275364|O1|Outcome|Test Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
28520|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
28521|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
28522|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
28523|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
28524|NCT02275364|O4|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
28525|NCT02275364|O3|Outcome|Decongestant|A marketed nasal decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
28526|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
28527|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
28528|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
28529|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
28530|NCT02275364|O4|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
28531|NCT02275364|O3|Outcome|Decongestant|A nasal decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
28532|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
28533|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
28534|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
28535|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
28536|NCT02275364|O4|Outcome|Test Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
28537|NCT02275364|O3|Outcome|Decongestant|A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
28538|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
28539|NCT02275364|O1|Outcome|Test Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
29480|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure
VTI= Valveless recirculating insufflation"
28540|NCT02275364|E4|Reported Event|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
28541|NCT02275364|E3|Reported Event|Decongestant|A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
28542|NCT02275364|E2|Reported Event|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
28543|NCT02275364|E1|Reported Event|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
28544|NCT02275156|B4|Baseline|Total|Total of all reporting groups
28545|NCT02275156|B3|Baseline|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28546|NCT02275156|B2|Baseline|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28547|NCT02275156|B1|Baseline|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28548|NCT02275156|P3|Participant Flow|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28549|NCT02275156|P2|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28550|NCT02275156|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28551|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28552|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28553|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28554|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28555|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28556|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28557|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28558|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28559|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28560|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28561|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28562|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28563|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28564|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28565|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28566|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28567|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28568|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28569|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28570|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28571|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28572|NCT02275156|E4|Reported Event|Evolocumab 140 mg - Total|Participants received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28573|NCT02275156|E3|Reported Event|Evolocumab 140 mg - ESRD Requiring Hemodialysis|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28574|NCT02275156|E2|Reported Event|Evolocumab 140 mg - Severe RI|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28575|NCT02275156|E1|Reported Event|Evolocumab 140 mg - Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
28576|NCT02275052|B1|Baseline|UMEC/VI 62.5/25 mcg and Placebo in One of the Two Sequences|Par. received a sequence consisting of the following 2 treatments: One inhalation of UMEC/VI 62.5/25 mcg or placebo once daily using a DPI. Each treatment was self-administered in the morning for 12 weeks. The treatments were separated by a 12 to 17 day washout period; all par. were provided with albuterol for use on an ‘as needed’ basis throughout the run-in, washout and study treatment periods while on investigational product.
28577|NCT02275052|P4|Participant Flow|Period 2: Placebo Then UMEC/VI 62.5/25 µg|Participants received placebo and then UMEC/VI 62.5 µg/25 µg each morning (once daily) as one inhalation via the DPI for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
28578|NCT02275052|P3|Participant Flow|Period 2: UMEC/VI 62.5/25 µg Then Placebo|Participants received UMEC/VI 62.5 µg/25 µg and then Placebo each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
28579|NCT02275052|P2|Participant Flow|UMEC/VI 62.5/25 µg Then Placebo|Participants received UMEC/ VI 62.5 µg/25 µg and then placebo each morning (once daily) as one inhalation via the DPI for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
28580|NCT02275052|P1|Participant Flow|Placebo Then UMEC/VI 62.5/25 µg|Participants received Placebo and then umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 micrograms (µg)/25 µg each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
28581|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
28582|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
28583|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
28584|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
28585|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
28586|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
28587|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
28588|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
28589|NCT02275052|E2|Reported Event|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
28590|NCT02275052|E1|Reported Event|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
28591|NCT02274948|B3|Baseline|Total|Total of all reporting groups
29481|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
28592|NCT02274948|B2|Baseline|Placebo|"173 were randomized to receive placebo
Metformin and placebo were manufactured by the State Pharmaceutical Manufacturing Corporation, Sri Lanka and both tablets look similar except for the active pharmacological compound in one"
28593|NCT02274948|B1|Baseline|Metformin|"166 were randomized to receive Metformin. After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166) and placebo (173).
Children, 8 to 10.99 years received metformin 250mg daily for a week and increased to 250mg twice daily for a week and thereafter 500 mg twice daily. Eleven to 16 year old children received 500mg of metformin daily for one week and increased to 500mg twice daily for a week and thereafter 1g twice daily. Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia"
28594|NCT02274948|P2|Participant Flow|Placebo|"A placebo tablet which is physically similar to metformin tablets will be given in a similar manner as described above (the placebo is manufactured by the same manufacturer, State Pharmaceutical Manufacturing Corporation)
Metformin: A dummy tablet similar to Metformin will be administer to the control group"
28595|NCT02274948|P1|Participant Flow|Metformin|"8-10.99 year old children will receive metformin. Initially children will be given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children will receive 500mg of metformin daily initially for one week which will be increased to 500mg twice daily for a week and then to 1g twice daily. The medication will be continued for 12 months.
Metformin: A dummy tablet similar to Metformin will be administer to the control group"
28596|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
28597|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
28598|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
28599|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
28600|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
28601|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
28602|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
28603|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metforming (166)
28604|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
28605|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
28606|NCT02274948|E2|Reported Event|Placebo|"The placebo group was given medication in a similar manner and the number of tablets to be taken each occasion were similar to the treatment group
Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events."
28607|NCT02274948|E1|Reported Event|Metformin|"8-10.99 year old children received metformin. Initially children were given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children received 500mg of metformin daily initially for one week increased to 500mg twice daily for a week and then to 1g twice daily.
Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events."
28608|NCT02274792|B1|Baseline|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
28609|NCT02274792|P1|Participant Flow|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
28610|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
28611|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
28612|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
28613|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
28614|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
28615|NCT02274792|E1|Reported Event|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
28616|NCT02274688|B3|Baseline|Total|Total of all reporting groups
28617|NCT02274688|B2|Baseline|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed."
28618|NCT02274688|B1|Baseline|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
28619|NCT02274688|P2|Participant Flow|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed."
28620|NCT02274688|P1|Participant Flow|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
28621|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed."
41124|NCT02153489|O2|Outcome|Placebo|Placebo BID
28622|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
30704|NCT02248818|P6|Participant Flow|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
28623|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed."
28624|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
28625|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed."
28626|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
28627|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed."
28628|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
28629|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed."
28630|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
28631|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed."
28632|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
28633|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Stepped Care Management: Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements."
28634|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
28635|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed."
28636|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
28637|NCT02274688|O2|Outcome|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed."
28638|NCT02274688|O1|Outcome|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
28639|NCT02274688|E2|Reported Event|Patient-centered Care Transition|"Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed."
28640|NCT02274688|E1|Reported Event|Enhanced Usual Care - Nurse Notification of Patient Concerns|"Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed."
28641|NCT02274675|B1|Baseline|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
28642|NCT02274675|P1|Participant Flow|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
28643|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
28644|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
28645|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
28646|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
28647|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
29891|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM
PRFM
Double Row"
28694|NCT02273908|E1|Reported Event|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care No intervention: The study is observational
28648|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
28649|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
28650|NCT02274675|E1|Reported Event|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
28651|NCT02274558|B4|Baseline|Total|Total of all reporting groups
28652|NCT02274558|B3|Baseline|Placebo-Controlled Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
28653|NCT02274558|B2|Baseline|Placebo-Controlled Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
28654|NCT02274558|B1|Baseline|Placebo-Controlled Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
28655|NCT02274558|P3|Participant Flow|Placebo-Controlled Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
28656|NCT02274558|P2|Participant Flow|Placebo-Controlled Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
28657|NCT02274558|P1|Participant Flow|Placebo-Controlled Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
28658|NCT02274558|O3|Outcome|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
28659|NCT02274558|O2|Outcome|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
28660|NCT02274558|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
28661|NCT02274558|O3|Outcome|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
28662|NCT02274558|O2|Outcome|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
28663|NCT02274558|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
28664|NCT02274558|O3|Outcome|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
28665|NCT02274558|O2|Outcome|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
28666|NCT02274558|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
28667|NCT02274558|E3|Reported Event|Valbenazine 80mg|Participants received valbenazine 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
28668|NCT02274558|E2|Reported Event|Valbenazine 40mg|Participants received valbenazine 40mg capsule once daily for 6 weeks.
28669|NCT02274558|E1|Reported Event|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
28670|NCT02273908|B3|Baseline|Total|Total of all reporting groups
28671|NCT02273908|B2|Baseline|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care :no intervention
28672|NCT02273908|B1|Baseline|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care :no intervention
28673|NCT02273908|P2|Participant Flow|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
28674|NCT02273908|P1|Participant Flow|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
28675|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care : No intervention
28676|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care : no intervention
28677|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
28678|NCT02273908|O2|Outcome|Other Analgesics|2.Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
28679|NCT02273908|O1|Outcome|Pregabalin|1.Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
28680|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
28681|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
28682|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
28683|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
28684|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
28685|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
28686|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
28687|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
28688|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
28689|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
28690|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
29892|NCT02256891|O1|Outcome|Double Row|"Double Row
Double Row"
28695|NCT02273752|B1|Baseline|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.
Everolimus: Given PO"
28696|NCT02273752|P1|Participant Flow|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic therapeutic drug monitoring (TDM) on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.
Everolimus: Given PO"
28697|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.
Everolimus: Given PO"
28698|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.
Everolimus: Given PO"
28699|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.
Everolimus: Given PO"
28700|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.
Everolimus: Given PO"
28701|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.
Everolimus: Given PO"
28702|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.
Everolimus: Given PO"
28703|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.
Everolimus: Given PO"
28704|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.
Everolimus: Given PO"
28742|NCT02273167|P2|Participant Flow|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
29482|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure
VTI= Valveless recirculating insufflation"
28743|NCT02273167|P1|Participant Flow|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28705|NCT02273752|E1|Reported Event|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.
Everolimus: Given PO"
28706|NCT02273323|B1|Baseline|All Study Participants|Participants who were randomised to either receive Tea first followed by Placebo or Placebo first followed by Tea
28707|NCT02273323|P2|Participant Flow|Placebo Then Tea|Subjects first received a single acute dose of placebo consisting of tea flavour, colouring and sugar. After a washout of at least 1 week, they received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar
28708|NCT02273323|P1|Participant Flow|Tea Then Placebo|Subjects first received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar. After a washout of at least 1 week, they received a single acute dose of placebo consisting of tea flavour, colouring and sugar.
28709|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
28710|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
28711|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
28712|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
28713|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
28714|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
28715|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
28716|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
28717|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
28718|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
28719|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
28720|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
28721|NCT02273323|E2|Reported Event|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
28722|NCT02273323|E1|Reported Event|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
28723|NCT02273310|B3|Baseline|Total|Total of all reporting groups
28724|NCT02273310|B2|Baseline|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
28725|NCT02273310|B1|Baseline|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention
Problem Solving Training for Disease Management"
28726|NCT02273310|P2|Participant Flow|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
28727|NCT02273310|P1|Participant Flow|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention
Problem Solving Training for Disease Management"
28728|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day Problem-Solving Skills training for disease management intervention
Problem-Solving Skills Training for Disease Management: Children and caregivers participated in a multi-family group to learn problem-solving skills as applied to disease management and school functioning in the context of sickle cell disease."
28729|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
28730|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention
Problem Solving Training for Disease Management"
28731|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
28732|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention
Problem Solving Training for Disease Management"
28733|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
28734|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention
Problem Solving Training for Disease Management"
28735|NCT02273310|E2|Reported Event|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
28736|NCT02273310|E1|Reported Event|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention
Problem Solving Training for Disease Management"
28737|NCT02273167|B4|Baseline|Total|Total of all reporting groups
28738|NCT02273167|B3|Baseline|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
28739|NCT02273167|B2|Baseline|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28740|NCT02273167|B1|Baseline|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28741|NCT02273167|P3|Participant Flow|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
28838|NCT02272725|O2|Outcome|Ibuprofen|"Each tablet containing 400mg of ibuprofen
Ibuprofen: Ibuprofen"
28744|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
28745|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28746|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28747|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
28748|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28749|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28750|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
28751|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28752|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28753|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
28754|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28755|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28756|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
28757|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28758|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28759|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
28760|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28761|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28762|NCT02273167|E3|Reported Event|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
28763|NCT02273167|E2|Reported Event|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28764|NCT02273167|E1|Reported Event|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
28765|NCT02273141|B3|Baseline|Total|Total of all reporting groups
28766|NCT02273141|B2|Baseline|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
28767|NCT02273141|B1|Baseline|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the moring of the day before colonoscopy).
28768|NCT02273141|P2|Participant Flow|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
28769|NCT02273141|P1|Participant Flow|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
28770|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
28771|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
28772|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
28773|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
28774|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
28775|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
28776|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
28777|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
28778|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
28779|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
28780|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
28781|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
28782|NCT02273141|E2|Reported Event|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
28783|NCT02273141|E1|Reported Event|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
28784|NCT02273115|B5|Baseline|Total|Total of all reporting groups
28839|NCT02272725|O1|Outcome|Placebo|"tasteless and inert tablets
Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
28845|NCT02272725|E1|Reported Event|Placebo|"tasteless and inert tablets
Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
28785|NCT02273115|B4|Baseline|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28786|NCT02273115|B3|Baseline|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28787|NCT02273115|B2|Baseline|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28788|NCT02273115|B1|Baseline|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28789|NCT02273115|P4|Participant Flow|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28790|NCT02273115|P3|Participant Flow|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28791|NCT02273115|P2|Participant Flow|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28792|NCT02273115|P1|Participant Flow|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28793|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28840|NCT02272725|O2|Outcome|Ibuprofen|"Each tablet containing 400mg of ibuprofen
Ibuprofen: Ibuprofen"
28841|NCT02272725|O1|Outcome|Placebo|"tasteless and inert tablets
Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
28842|NCT02272725|O2|Outcome|Ibuprofen|"Each tablet containing 400mg of ibuprofen
Ibuprofen: Ibuprofen"
28843|NCT02272725|O1|Outcome|Placebo|"tasteless and inert tablets
Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
28844|NCT02272725|E2|Reported Event|Ibuprofen|"Each tablet containing 400mg of ibuprofen
Ibuprofen: Ibuprofen"
28794|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28795|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28796|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28797|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28798|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28799|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28800|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28801|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28802|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28803|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28804|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28805|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28806|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28807|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28808|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28809|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28810|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28811|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28812|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28813|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28814|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28815|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28816|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28817|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28818|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28819|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28820|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28821|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28822|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28823|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28824|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28825|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28826|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28827|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28828|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28829|NCT02273115|E4|Reported Event|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28830|NCT02273115|E3|Reported Event|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28831|NCT02273115|E2|Reported Event|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter"
28832|NCT02273115|E1|Reported Event|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter"
28833|NCT02272725|B3|Baseline|Total|Total of all reporting groups
28834|NCT02272725|B2|Baseline|Ibuprofen|"Each tablet containing 400mg of ibuprofen
Ibuprofen: Ibuprofen"
28835|NCT02272725|B1|Baseline|Placebo|"tasteless and inert tablets
Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
28836|NCT02272725|P2|Participant Flow|Ibuprofen|"Each tablet containing 400mg of ibuprofen
Ibuprofen: Ibuprofen"
28837|NCT02272725|P1|Participant Flow|Placebo|"tasteless and inert tablets
Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
29483|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
28846|NCT02271854|B1|Baseline|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily
Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
28847|NCT02271854|P1|Participant Flow|Diclofenac Sodium Gel 1% and Placebo Gel|This study is a within-subject design i.e. diclofenac sodium gel 1% four times a day applied to one leg and placebo gel four times a day applied to the other leg to the other leg at the same time
28848|NCT02271854|O2|Outcome|Placebo|"Placebo gel applied four times daily
Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
28849|NCT02271854|O1|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily
Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
28850|NCT02271854|O2|Outcome|Placebo|"Placebo gel applied four times daily
Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
28851|NCT02271854|O1|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily
Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
28852|NCT02271854|E1|Reported Event|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily
Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
28853|NCT02271698|B5|Baseline|Total|Total of all reporting groups
28854|NCT02271698|B4|Baseline|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
28855|NCT02271698|B3|Baseline|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28856|NCT02271698|B2|Baseline|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28857|NCT02271698|B1|Baseline|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28858|NCT02271698|P4|Participant Flow|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
28859|NCT02271698|P3|Participant Flow|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28860|NCT02271698|P2|Participant Flow|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28861|NCT02271698|P1|Participant Flow|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28862|NCT02271698|O4|Outcome|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
28863|NCT02271698|O3|Outcome|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28864|NCT02271698|O2|Outcome|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28865|NCT02271698|O1|Outcome|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28866|NCT02271698|O4|Outcome|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
28867|NCT02271698|O3|Outcome|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
29893|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM
PRFM
Double Row"
29155|NCT02266381|E3|Reported Event|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
28868|NCT02271698|O2|Outcome|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28869|NCT02271698|O1|Outcome|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28870|NCT02271698|E4|Reported Event|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
28871|NCT02271698|E3|Reported Event|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28872|NCT02271698|E2|Reported Event|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28873|NCT02271698|E1|Reported Event|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
28874|NCT02271529|B1|Baseline|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
28875|NCT02271529|P1|Participant Flow|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
28876|NCT02271529|O1|Outcome|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
28877|NCT02271529|E1|Reported Event|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
28878|NCT02271477|B3|Baseline|Total|Total of all reporting groups
28879|NCT02271477|B2|Baseline|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
28880|NCT02271477|B1|Baseline|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
28881|NCT02271477|P2|Participant Flow|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.
After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness, previously defined as a reduction of Inferior Vena Cava diameter less than 36%"
28882|NCT02271477|P1|Participant Flow|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
28883|NCT02271477|O2|Outcome|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.
Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness"
28899|NCT02270944|O1|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
28884|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
28885|NCT02271477|O2|Outcome|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
28886|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
28887|NCT02271477|O2|Outcome|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.
Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness"
28888|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
28889|NCT02271477|O2|Outcome|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
28890|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
28891|NCT02271477|E2|Reported Event|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
28892|NCT02271477|E1|Reported Event|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
28893|NCT02270944|B3|Baseline|Total|Total of all reporting groups
28894|NCT02270944|B2|Baseline|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
28895|NCT02270944|B1|Baseline|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
28896|NCT02270944|P2|Participant Flow|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
28897|NCT02270944|P1|Participant Flow|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
28898|NCT02270944|O2|Outcome|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
28967|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
28900|NCT02270944|O2|Outcome|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
28901|NCT02270944|O1|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
28902|NCT02270944|O2|Outcome|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
28903|NCT02270944|O1|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine.
28904|NCT02270944|O2|Outcome|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
28905|NCT02270944|O1|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
28906|NCT02270944|O2|Outcome|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
28907|NCT02270944|O1|Outcome|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
28908|NCT02270944|E2|Reported Event|Lyophilized GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
28909|NCT02270944|E1|Reported Event|Liquid GBS Trivalent Vaccine|Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine
28910|NCT02270684|B3|Baseline|Total|Total of all reporting groups
28911|NCT02270684|B2|Baseline|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
28912|NCT02270684|B1|Baseline|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment
StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
28913|NCT02270684|P2|Participant Flow|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
28914|NCT02270684|P1|Participant Flow|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment
StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
28915|NCT02270684|O2|Outcome|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
28916|NCT02270684|O1|Outcome|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment
StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
28917|NCT02270684|E2|Reported Event|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
28918|NCT02270684|E1|Reported Event|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment
StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
28919|NCT02270515|B1|Baseline|PCMH-KD Dialysis Care|Enrolled patients had access to an expanded care team inlcuding a primary care doctor, nurse coordinator, community health worker, and pharmacist.
28920|NCT02270515|P1|Participant Flow|PCMH-KD Dialysis Care|"Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and a pharmacist.
Patient-Centered Medical Home for Kidney Disease (PCMH-KD): A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team."
28921|NCT02270515|O4|Outcome|Change 0-18 Months|Change of mean score from Baseline (0) to 18 months
28922|NCT02270515|O3|Outcome|Change 12-18 Months|Change of mean score from 12 months to 18 months
28923|NCT02270515|O2|Outcome|Change 6-12 Months|Change of mean score from 6 months to 12 months
28924|NCT02270515|O1|Outcome|Change 0-6 Months|Change of mean score from Baseline (0) to 6 months
28925|NCT02270515|O4|Outcome|18 Months|KDQOL collected at 18 months
28926|NCT02270515|O3|Outcome|12 Months|KDQOL collected at 12 months
28927|NCT02270515|O2|Outcome|6 Months|KDQOL collected at 6 months
28928|NCT02270515|O1|Outcome|Baseline|KDQOL collected at Baseline
28929|NCT02270515|O4|Outcome|18 Months|KDQOL collected at 18 months
28930|NCT02270515|O3|Outcome|12 Months|KDQOL collected at 12 months
28931|NCT02270515|O2|Outcome|6 Months|KDQOL collected at 6 months
28932|NCT02270515|O1|Outcome|Baseline|KDQOL collected at Baseline
28933|NCT02270515|E1|Reported Event|PCMH-KD Dialysis Care|"Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and pharmacist.
Patient-Centered Medical Home for Kidney Disease (PCMH-KD): A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team."
28934|NCT02269709|B1|Baseline|ARFI Ultrasound|Subjects were pediatric patients who had undergone a Fontan operation. Subjects underwent an ultrasound before and after the Fontan operation. The ultrasound scan used acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a non-invasive scan that uses sound waves to create images of the liver and measure the stiffness of the tissue.
28935|NCT02269709|P1|Participant Flow|ARFI Ultrasound|"Subjects were pediatric patients who had undergone a repair of a heart defect, called a Fontan operation. Patients underwent an ultrasound before and after the Fontan operation.
The ultrasound scan used acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a non-invasive scan that uses sound waves to create images of the liver and measure its stiffness."
28936|NCT02269709|O1|Outcome|ARFI Ultrasound|Subjects underwent an ultrasound scan before and after the Fontan operation. The blood pressure in the IVC (interior vena cava) was measured.
28937|NCT02269709|O1|Outcome|ARFI Ultrasound|Subjects underwent an ultrasound scan before and after the Fontan operation.
28938|NCT02269709|E1|Reported Event|ARFI Ultrasound|Subjects underwent an ultrasound scan before and after the Fontan operation.
28939|NCT02269657|B1|Baseline|Subject Cohort|Two bi-planar full spinal X-rays were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
28940|NCT02269657|P1|Participant Flow|Subject Cohort|Two bi-planar full spinal X-ray were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
28941|NCT02269657|O3|Outcome|Natural Standing Position|Subjects stood with their arms hanging on either side. Images were not taken but a pressure mat recording of the position of the arm center of pressure during this arm position was recorded.
28942|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
28943|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
28944|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
28945|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
28946|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
28947|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
28948|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
28949|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
28950|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
28951|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
28952|NCT02269657|E1|Reported Event|Subject Cohort|Two bi-planar full spinal X-ray were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
28953|NCT02269488|B1|Baseline|MEDI3250|MEDI3250 was administered to all subjects.
28954|NCT02269488|P1|Participant Flow|MEDI3250|MEDI3250 was administered to all subjects.
28955|NCT02269488|O1|Outcome|MEDI3250|MEDI3250 was administered to all subjects.
28956|NCT02269488|E1|Reported Event|MEDI3250|MEDI3250 was administered to all subjects.
28957|NCT02269475|B3|Baseline|Total|Total of all reporting groups
28958|NCT02269475|B2|Baseline|Placebo|Placebo, 0.2mL as nasal spray
28959|NCT02269475|B1|Baseline|MEDI3250|MEDI3250, 0.2mL as nasal spray
28960|NCT02269475|P2|Participant Flow|Placebo|Placebo, 0.2mL as nasal spray
28961|NCT02269475|P1|Participant Flow|MEDI3250|MEDI3250, 0.2mL as nasal spray
28962|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
28963|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
28964|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
28965|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
28966|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
28972|NCT02269098|B2|Baseline|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
28973|NCT02269098|B1|Baseline|Intervention|"Diabetes survival skills self-management education (G meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED. ; plus diabetes medication management using medication algorithm ( Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.
Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
28974|NCT02269098|P2|Participant Flow|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
28975|NCT02269098|P1|Participant Flow|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.
.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
28976|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
28977|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education; plus diabetes medication management using medication algorithm by diabetes educator supervised by endocrinologist, plus health system naviagation.
Metformin, sulfonylureas and basal insulin were included in the algorithm. Survival skills DSME included: BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.
Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Navigation included securing a primary care"
28978|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
28979|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.
.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
28980|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
28981|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.
.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
29149|NCT02266381|O3|Outcome|Combined Group|Patients in Combined group undergo MPCNL using US combined with fluoroscopy-guided renal access.
29894|NCT02256891|O1|Outcome|Double Row|"Double Row
Double Row"
28982|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
28983|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.
.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
28984|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
28985|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.
.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
28986|NCT02269098|E2|Reported Event|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
28987|NCT02269098|E1|Reported Event|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.
.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
28988|NCT02268877|B3|Baseline|Total|Total of all reporting groups
28989|NCT02268877|B2|Baseline|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.
Ultrasound: An ultrasound will be performed by a radiology department technician"
28990|NCT02268877|B1|Baseline|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician"
28991|NCT02268877|P2|Participant Flow|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.
Ultrasound: An ultrasound will be performed by a radiology department technician"
28992|NCT02268877|P1|Participant Flow|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician"
28993|NCT02268877|O2|Outcome|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.
Ultrasound: An ultrasound will be performed by a radiology department technician"
28994|NCT02268877|O1|Outcome|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician"
28995|NCT02268877|O2|Outcome|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.
Ultrasound: An ultrasound will be performed by a radiology department technician"
29150|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
28996|NCT02268877|O1|Outcome|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician"
28997|NCT02268877|E2|Reported Event|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.
Ultrasound: An ultrasound will be performed by a radiology department technician"
28998|NCT02268877|E1|Reported Event|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician"
28999|NCT02268864|B4|Baseline|Total|Total of all reporting groups
29000|NCT02268864|B3|Baseline|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
29001|NCT02268864|B2|Baseline|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
29002|NCT02268864|B1|Baseline|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
29003|NCT02268864|P3|Participant Flow|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
29004|NCT02268864|P2|Participant Flow|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
29005|NCT02268864|P1|Participant Flow|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
29006|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24 week treatment after amendment.
29007|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12 week treatment period after amendment.
29008|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12 week treatment before Amendment 3 of the protocol was implemented.
29009|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24 week treatment after amendment.
29010|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12 week treatment period after amendment.
29011|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12 week treatment before Amendment 3 of the protocol was implemented.
29012|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
29013|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
29014|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
29015|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
29016|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
29017|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
29018|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
29019|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
29020|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
29021|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
29151|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided undergo MPCNL using only US-guided renal access.
29022|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
29023|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
29024|NCT02268864|E2|Reported Event|12-24 Weeks|Simeprevir 150 mg once daily as an oral capsule in combination with Daclatasvir 60 mg once daily as an oral tablet for participants who has AEs that started after day 88 on treatment.
29025|NCT02268864|E1|Reported Event|1-12 Weeks|Simeprevir 150 mg once daily as an oral capsule in combination with Daclatasvir 60 mg once daily as an oral tablet for participants who has adverse events (AEs) that started before or on day 88 on treatment.
29026|NCT02268396|B1|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
29027|NCT02268396|P1|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
29028|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
29029|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
29030|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
29031|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
29032|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
29033|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
29034|NCT02268396|E1|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
29035|NCT02268058|B5|Baseline|Total|Total of all reporting groups
29036|NCT02268058|B4|Baseline|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
29037|NCT02268058|B3|Baseline|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period"
29038|NCT02268058|B2|Baseline|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period"
29039|NCT02268058|B1|Baseline|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period"
29040|NCT02268058|P4|Participant Flow|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
29041|NCT02268058|P3|Participant Flow|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period"
29042|NCT02268058|P2|Participant Flow|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period"
29043|NCT02268058|P1|Participant Flow|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period"
29044|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
29045|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period"
29046|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period"
29047|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period"
29048|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
29049|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period"
29050|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period"
29051|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period"
29052|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
29053|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period"
29054|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period"
29055|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period"
29056|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
29057|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period"
29058|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period"
29059|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period"
29060|NCT02268058|E4|Reported Event|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.
The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
29061|NCT02268058|E3|Reported Event|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
Acetaminophen: routine administration of medication for a 72 hour period
Ibuprofen: routine administration of medication for a 72 hour period"
29062|NCT02268058|E2|Reported Event|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Ibuprofen: routine administration of medication for a 72 hour period"
29063|NCT02268058|E1|Reported Event|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
Acetaminophen: routine administration of medication for a 72 hour period"
29064|NCT02267837|B3|Baseline|Total|Total of all reporting groups
29065|NCT02267837|B2|Baseline|Control|Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
29066|NCT02267837|B1|Baseline|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
29067|NCT02267837|P2|Participant Flow|No OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.
Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
29068|NCT02267837|P1|Participant Flow|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
29152|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
29153|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
29069|NCT02267837|O2|Outcome|No OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.
Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
29070|NCT02267837|O1|Outcome|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
29071|NCT02267837|E2|Reported Event|No OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.
Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
29072|NCT02267837|E1|Reported Event|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
29073|NCT02267824|B3|Baseline|Total|Total of all reporting groups
29074|NCT02267824|B2|Baseline|Control|Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
29075|NCT02267824|B1|Baseline|Extra-Oral OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
Extra-Oral OrthoPulse™: Patients carry out daily extra-oral OrthoPulse™ treatments at home."
29076|NCT02267824|P2|Participant Flow|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only.
29077|NCT02267824|P1|Participant Flow|Extraoral OrthoPulse® PBM|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
29078|NCT02267824|O2|Outcome|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
29079|NCT02267824|O1|Outcome|Extraoral OrthoPulse® PBM and Orthodontic Treatment|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
29080|NCT02267824|E2|Reported Event|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
29081|NCT02267824|E1|Reported Event|Extraoral OrthoPulse® PBM|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
29082|NCT02267629|B1|Baseline|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.
Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
29083|NCT02267629|P1|Participant Flow|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.
Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
29084|NCT02267629|O1|Outcome|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.
Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
29085|NCT02267629|O1|Outcome|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.
Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
29086|NCT02267629|E1|Reported Event|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.
Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
29087|NCT02267447|B3|Baseline|Total|Total of all reporting groups
29088|NCT02267447|B2|Baseline|Validation Cohort|Eligible respondents to the 2007/2008 Canadian Community Health Survey.
29089|NCT02267447|B1|Baseline|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
29090|NCT02267447|P2|Participant Flow|Validation Cohort|Eligible respondents to the 2007 and 2009 Canadian Community Health Surveys.
29091|NCT02267447|P1|Participant Flow|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
29092|NCT02267447|O2|Outcome|Validation Cohort|Eligible respondents to the 2007/2008 Canadian Community Health Surveys.
29093|NCT02267447|O1|Outcome|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
29094|NCT02267447|O2|Outcome|Validation Cohort|Eligible respondents to the 2007 /2008 Canadian Community Health Surveys.
29095|NCT02267447|O1|Outcome|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
29096|NCT02267447|E2|Reported Event|Validation Cohort|Eligible respondents to the 2007/2008 Canadian Community Health Surveys.
29097|NCT02267447|E1|Reported Event|Derivation Cohort|Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
29098|NCT02266797|B3|Baseline|Total|Total of all reporting groups
29099|NCT02266797|B2|Baseline|Saline|"Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
29100|NCT02266797|B1|Baseline|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
29101|NCT02266797|P2|Participant Flow|Saline|"Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
29102|NCT02266797|P1|Participant Flow|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
29103|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
29104|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
29105|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
29106|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
29107|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
29108|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
29109|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
29110|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
29111|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
29112|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
29113|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
29114|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
29115|NCT02266797|E2|Reported Event|Saline|"Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
29116|NCT02266797|E1|Reported Event|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
29117|NCT02266472|B3|Baseline|Total|Total of all reporting groups
29154|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
29484|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure
VTI= Valveless recirculating insufflation"
29118|NCT02266472|B2|Baseline|Fed 10mg+1000mg Single/FDC (RT)|Subjects received in period 1 a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
29119|NCT02266472|B1|Baseline|Fed 10mg+1000mg FDC/Single (TR)|Subjects received in period 1 a single dose of 10 mg empagliflozin/1000 mg metformin hydrochloride (HCl) extended release (XR) (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
29120|NCT02266472|P2|Participant Flow|Fed 10mg+1000mg Single/FDC (RT)|Subjects received in period 1 a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
29121|NCT02266472|P1|Participant Flow|Fed 10mg+1000mg Fixed Dose Combination (FDC)/Single (TR)|Subjects received in period 1 a single dose of 10 mg empagliflozin/1000 mg metformin hydrochloride (HCl) extended release (XR) (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
29122|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
29123|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
29124|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
29125|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
29126|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
29127|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
29128|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
29129|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
29130|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
29131|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
29132|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
29133|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
29134|NCT02266472|E2|Reported Event|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
29135|NCT02266472|E1|Reported Event|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
29136|NCT02266381|B4|Baseline|Total|Total of all reporting groups
29137|NCT02266381|B3|Baseline|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
29138|NCT02266381|B2|Baseline|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
29139|NCT02266381|B1|Baseline|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
29140|NCT02266381|P3|Participant Flow|Combined-guided Group|Patients in combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
29141|NCT02266381|P2|Participant Flow|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
29142|NCT02266381|P1|Participant Flow|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
29143|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
29144|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
29145|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
29146|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
29147|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
29485|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
29156|NCT02266381|E2|Reported Event|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
29157|NCT02266381|E1|Reported Event|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
29158|NCT02266277|B7|Baseline|Total|Total of all reporting groups
29159|NCT02266277|B6|Baseline|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
29160|NCT02266277|B5|Baseline|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only
Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29161|NCT02266277|B4|Baseline|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
29162|NCT02266277|B3|Baseline|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only
Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29163|NCT02266277|B2|Baseline|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only
Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29164|NCT02266277|B1|Baseline|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call
Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29165|NCT02266277|P6|Participant Flow|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
29166|NCT02266277|P5|Participant Flow|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only
Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29167|NCT02266277|P4|Participant Flow|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
29168|NCT02266277|P3|Participant Flow|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only
Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29169|NCT02266277|P2|Participant Flow|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only
Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29170|NCT02266277|P1|Participant Flow|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with Interactive Voice Recognition (IVR) call
Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29171|NCT02266277|O2|Outcome|IVR Self-Report|Patients who received IVR questionnaire.
29172|NCT02266277|O1|Outcome|Portal Self-Report|Patients who received portal questionnaire.
29173|NCT02266277|O6|Outcome|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
29174|NCT02266277|O5|Outcome|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only
Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29175|NCT02266277|O4|Outcome|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
29176|NCT02266277|O3|Outcome|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only
Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29177|NCT02266277|O2|Outcome|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only
Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29178|NCT02266277|O1|Outcome|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call
Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29179|NCT02266277|O6|Outcome|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
41125|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
29252|NCT02264821|O2|Outcome|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration
intrathecal morphine: 100 µg added to the spinal anaesthesia"
29180|NCT02266277|O5|Outcome|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only
Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29181|NCT02266277|O4|Outcome|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
29182|NCT02266277|O3|Outcome|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only
Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29183|NCT02266277|O2|Outcome|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only
Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29184|NCT02266277|O1|Outcome|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call
Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29185|NCT02266277|E6|Reported Event|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
29186|NCT02266277|E5|Reported Event|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only
Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29187|NCT02266277|E4|Reported Event|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
29188|NCT02266277|E3|Reported Event|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only
Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29189|NCT02266277|E2|Reported Event|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only
Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29190|NCT02266277|E1|Reported Event|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call
Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
29191|NCT02265848|B3|Baseline|Total|Total of all reporting groups
29192|NCT02265848|B2|Baseline|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29193|NCT02265848|B1|Baseline|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29194|NCT02265848|P2|Participant Flow|Treatment Group B|"Subjects randomized to the treatment group B will begin the 7 week study per sequence (e.g., Low frequency first, then High frequency and High frequency first, then Low frequency), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of wash off periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study."
29195|NCT02265848|P1|Participant Flow|Treatment Group A|"Subjects randomized to the treatment group A will begin the 7 week study per sequence (e.g., High frequency first, then Low frequency and Low frequency first, then High frequency), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of wash off periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study."
29196|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29211|NCT02265237|B4|Baseline|Arm D|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
29212|NCT02265237|B3|Baseline|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
29197|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29198|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29199|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29200|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29201|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29202|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29203|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29204|NCT02265848|E2|Reported Event|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29205|NCT02265848|E1|Reported Event|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
29206|NCT02265783|B1|Baseline|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
29207|NCT02265783|P1|Participant Flow|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
29208|NCT02265783|O1|Outcome|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
29209|NCT02265783|E1|Reported Event|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
29210|NCT02265237|B5|Baseline|Total|Total of all reporting groups
29213|NCT02265237|B2|Baseline|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
29214|NCT02265237|B1|Baseline|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
29215|NCT02265237|P4|Participant Flow|Arm D|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
29216|NCT02265237|P3|Participant Flow|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
29217|NCT02265237|P2|Participant Flow|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
29218|NCT02265237|P1|Participant Flow|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
29219|NCT02265237|O3|Outcome|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
29220|NCT02265237|O2|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
29221|NCT02265237|O1|Outcome|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
29222|NCT02265237|O3|Outcome|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
29223|NCT02265237|O2|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
29224|NCT02265237|O1|Outcome|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
29225|NCT02265237|O2|Outcome|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
29226|NCT02265237|O1|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
29227|NCT02265237|O2|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
29228|NCT02265237|O1|Outcome|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
29229|NCT02265237|O3|Outcome|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
29230|NCT02265237|O2|Outcome|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
29231|NCT02265237|O1|Outcome|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
29232|NCT02265237|E4|Reported Event|Arm D|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
29233|NCT02265237|E3|Reported Event|Arm C|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
29234|NCT02265237|E2|Reported Event|Arm B|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
29235|NCT02265237|E1|Reported Event|Arm A|Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
29236|NCT02264977|B1|Baseline|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
29237|NCT02264977|P1|Participant Flow|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
29238|NCT02264977|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
29239|NCT02264977|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
29240|NCT02264977|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
29241|NCT02264977|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
29242|NCT02264977|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
29243|NCT02264977|E1|Reported Event|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
29244|NCT02264821|B4|Baseline|Total|Total of all reporting groups
29245|NCT02264821|B3|Baseline|Placebo|"intrathecal saline and saline infiltration
placebo: placebo in spinal anaesthesia and in wound infiltration"
29246|NCT02264821|B2|Baseline|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration
intrathecal morphine: 100 µg added to the spinal anaesthesia"
29247|NCT02264821|B1|Baseline|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline
ropivacaine infiltration: wound infiltration"
29248|NCT02264821|P3|Participant Flow|Placebo|"intrathecal saline and saline infiltration
placebo: placebo in spinal anaesthesia and in wound infiltration"
29249|NCT02264821|P2|Participant Flow|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration
intrathecal morphine: 100 µg added to the spinal anaesthesia"
29250|NCT02264821|P1|Participant Flow|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline
ropivacaine infiltration: wound infiltration"
29251|NCT02264821|O3|Outcome|Placebo|"intrathecal saline and saline infiltration
placebo: placebo in spinal anaesthesia and in wound infiltration"
29486|NCT02262039|E2|Reported Event|Low Pressure (VTI)|"10mmHg target pressure
VTI= Valveless recirculating insufflation"
29253|NCT02264821|O1|Outcome|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline
ropivacaine infiltration: wound infiltration"
29254|NCT02264821|O3|Outcome|Placebo|"intrathecal saline and saline infiltration
placebo: placebo in spinal anaesthesia and in wound infiltration"
29255|NCT02264821|O2|Outcome|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration
intrathecal morphine: 100 µg added to the spinal anaesthesia"
29256|NCT02264821|O1|Outcome|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline
ropivacaine infiltration: wound infiltration"
29257|NCT02264821|E3|Reported Event|Placebo|"intrathecal saline and saline infiltration
placebo: placebo in spinal anaesthesia and in wound infiltration"
29258|NCT02264821|E2|Reported Event|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration
intrathecal morphine: 100 µg added to the spinal anaesthesia"
29259|NCT02264821|E1|Reported Event|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline
ropivacaine infiltration: wound infiltration"
29260|NCT02264249|B4|Baseline|Total|Total of all reporting groups
29261|NCT02264249|B3|Baseline|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29262|NCT02264249|B2|Baseline|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29263|NCT02264249|B1|Baseline|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29264|NCT02264249|P3|Participant Flow|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29265|NCT02264249|P2|Participant Flow|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29266|NCT02264249|P1|Participant Flow|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29267|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29268|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29269|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29270|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29271|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29272|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29273|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29274|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29275|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29276|NCT02264249|E3|Reported Event|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29277|NCT02264249|E2|Reported Event|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29278|NCT02264249|E1|Reported Event|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
29279|NCT02263911|B1|Baseline|Overall Study|All randomized participants.
29487|NCT02262039|E1|Reported Event|Conventional Pressure|15mmHg target pressure
29310|NCT02263131|B2|Baseline|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
29280|NCT02263911|P4|Participant Flow|Baricitinib Dosing Sequence 4|Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
29281|NCT02263911|P3|Participant Flow|Baricitinib Dosing Sequence 3|Single oral dose of study drug daily on 5 occasions: T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
29282|NCT02263911|P2|Participant Flow|Baricitinib Dosing Sequence 2|Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
29283|NCT02263911|P1|Participant Flow|Baricitinib Dosing Sequence 1|Single oral dose of study drug daily on 5 occasions: Test Treatment 1 (T1) = Baricitinib 2 × 4 milligram (mg) commercial formulation tablets in a fasted state, Reference Treatment 1 (R1) = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, Test Treatment 2 (T2) = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, Reference Treatment 2 (R2) = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and (T2F) = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
29284|NCT02263911|O5|Outcome|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
29285|NCT02263911|O4|Outcome|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29286|NCT02263911|O3|Outcome|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29287|NCT02263911|O2|Outcome|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29288|NCT02263911|O1|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29289|NCT02263911|O5|Outcome|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
29290|NCT02263911|O4|Outcome|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29291|NCT02263911|O3|Outcome|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29292|NCT02263911|O2|Outcome|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29293|NCT02263911|O1|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets administered PO QD in the fasted state on Day 1 in one of five periods.
29294|NCT02263911|O5|Outcome|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
29295|NCT02263911|O4|Outcome|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29296|NCT02263911|O3|Outcome|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29297|NCT02263911|O2|Outcome|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29298|NCT02263911|O1|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets given orally (PO) once daily (QD) in the fasted state on Day 1 in one of five periods.
29299|NCT02263911|E5|Reported Event|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
29300|NCT02263911|E4|Reported Event|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29301|NCT02263911|E3|Reported Event|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29302|NCT02263911|E2|Reported Event|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
29303|NCT02263911|E1|Reported Event|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets administered PO QD in the fasted state on Day 1 in one of five periods.
29304|NCT02263833|B1|Baseline|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
29305|NCT02263833|P1|Participant Flow|Overall Participants|Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were prescribed Mircera either subcutaneously (SC) or intravenously (IV) according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
29306|NCT02263833|O1|Outcome|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
29307|NCT02263833|O1|Outcome|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
29308|NCT02263833|E1|Reported Event|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
29309|NCT02263131|B3|Baseline|Total|Total of all reporting groups
29311|NCT02263131|B1|Baseline|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
29312|NCT02263131|P2|Participant Flow|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
29313|NCT02263131|P1|Participant Flow|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
29314|NCT02263131|O2|Outcome|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
29315|NCT02263131|O1|Outcome|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
29316|NCT02263131|O2|Outcome|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
29317|NCT02263131|O1|Outcome|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
29318|NCT02263131|E2|Reported Event|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
29319|NCT02263131|E1|Reported Event|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
29320|NCT02263118|B5|Baseline|Total|Total of all reporting groups
29321|NCT02263118|B4|Baseline|Control Group|"Individuals were given a feature phone (simple mobile phone)
Feature phone: Participants were given a feature phone."
29322|NCT02263118|B3|Baseline|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
29323|NCT02263118|B2|Baseline|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS"
29324|NCT02263118|B1|Baseline|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone."
29325|NCT02263118|P4|Participant Flow|Control Group|"Individuals were given a feature phone (simple mobile phone)
Feature phone: Participants were given a feature phone."
29326|NCT02263118|P3|Participant Flow|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
29327|NCT02263118|P2|Participant Flow|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS"
29328|NCT02263118|P1|Participant Flow|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone."
29329|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)
Feature phone: Participants were given a feature phone."
29330|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
29331|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS"
29332|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone."
29333|NCT02263118|O4|Outcome|Control Group|"There were no virtual communities in this group: individuals were given a feature phone (simple mobile phone)
Feature phone: Participants were given a feature phone."
29334|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
29358|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29583|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29335|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS"
29336|NCT02263118|O1|Outcome|Uni-directional SMS|"There were no virtual communities in this group: participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone."
29337|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)
Feature phone: Participants were given a feature phone."
29338|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
29339|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS"
29340|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone."
29341|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)
Feature phone: Participants were given a feature phone."
29342|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
29343|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS"
29344|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone."
29345|NCT02263118|E4|Reported Event|Control Group|"Individuals were given a feature phone (simple mobile phone)
Feature phone: Participants were given a feature phone."
29346|NCT02263118|E3|Reported Event|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
29347|NCT02263118|E2|Reported Event|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone.
Virtual communities: Exposure to virtual community communication via SMS"
29348|NCT02263118|E1|Reported Event|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.
Uni-directional SMS: Exposure to breastfeeding promoting SMSs
Feature phone: Participants were given a feature phone."
29349|NCT02262754|B4|Baseline|Total|Total of all reporting groups
29350|NCT02262754|B3|Baseline|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29351|NCT02262754|B2|Baseline|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29352|NCT02262754|B1|Baseline|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29353|NCT02262754|P3|Participant Flow|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29354|NCT02262754|P2|Participant Flow|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29355|NCT02262754|P1|Participant Flow|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29356|NCT02262754|O1|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29357|NCT02262754|O1|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29472|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure
VTI= Valveless recirculating insufflation"
29359|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29360|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29361|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29362|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29363|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29364|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29365|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29366|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29367|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29368|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29369|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29370|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29371|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29372|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29373|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29374|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29375|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29376|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29377|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29378|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29379|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29380|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29381|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29382|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29383|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29384|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29385|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29386|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29387|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29388|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29389|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29390|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29391|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29392|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29393|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29394|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29395|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29396|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29397|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29398|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29399|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29400|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29401|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29402|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29403|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29404|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29405|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29406|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29407|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29408|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29409|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29410|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29411|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29412|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29413|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29414|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29415|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29416|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29417|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29418|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29419|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29420|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29421|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29422|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29423|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29424|NCT02262754|E3|Reported Event|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
29425|NCT02262754|E2|Reported Event|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
29426|NCT02262754|E1|Reported Event|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
29427|NCT02262728|B3|Baseline|Total|Total of all reporting groups
29428|NCT02262728|B2|Baseline|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29429|NCT02262728|B1|Baseline|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29430|NCT02262728|P2|Participant Flow|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29431|NCT02262728|P1|Participant Flow|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29432|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29433|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29434|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29435|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29436|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29437|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29438|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29439|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29440|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29441|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29442|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29443|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29444|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29445|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29473|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
29474|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure
VTI= Valveless recirculating insufflation"
29446|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29447|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29448|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29449|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29450|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29451|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29452|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29453|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29454|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29455|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29456|NCT02262728|E2|Reported Event|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29457|NCT02262728|E1|Reported Event|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
29458|NCT02262078|B3|Baseline|Total|Total of all reporting groups
29459|NCT02262078|B2|Baseline|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer
Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
29460|NCT02262078|B1|Baseline|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer
Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
29461|NCT02262078|P2|Participant Flow|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer
Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
29462|NCT02262078|P1|Participant Flow|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer
Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
29463|NCT02262078|O2|Outcome|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer
Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
29464|NCT02262078|O1|Outcome|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer
Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
29465|NCT02262078|E2|Reported Event|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer
Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
29466|NCT02262078|E1|Reported Event|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer
Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
29467|NCT02262039|B3|Baseline|Total|Total of all reporting groups
29468|NCT02262039|B2|Baseline|Low Pressure (VTI)|"10mmHg target pressure
VTI= Valveless recirculating insufflation"
29469|NCT02262039|B1|Baseline|Conventional Pressure|15mmHg target pressure
29470|NCT02262039|P2|Participant Flow|Low Pressure (VTI)|"10mmHg target pressure
VTI = Valveless recirculating insufflation"
29471|NCT02262039|P1|Participant Flow|Conventional Pressure|15mmHg target pressure
29475|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
29489|NCT02261948|B2|Baseline|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29490|NCT02261948|B1|Baseline|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29491|NCT02261948|P2|Participant Flow|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29492|NCT02261948|P1|Participant Flow|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29493|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29494|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29495|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29496|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29517|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29518|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
41126|NCT02153489|E2|Reported Event|Placebo|Placebo BID
29497|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29498|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29499|NCT02261948|E2|Reported Event|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29500|NCT02261948|E1|Reported Event|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.
Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
29501|NCT02261493|B4|Baseline|Total|Total of all reporting groups
29502|NCT02261493|B3|Baseline|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29503|NCT02261493|B2|Baseline|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29504|NCT02261493|B1|Baseline|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
29505|NCT02261493|P3|Participant Flow|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29506|NCT02261493|P2|Participant Flow|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29507|NCT02261493|P1|Participant Flow|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
29508|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29509|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29510|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
29511|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29512|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29513|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
29514|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29515|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29516|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
29895|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM
PRFM
Double Row"
29519|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
29520|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29521|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29522|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
29523|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29524|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29525|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
29526|NCT02261493|O3|Outcome|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29527|NCT02261493|O2|Outcome|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29528|NCT02261493|O1|Outcome|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
29529|NCT02261493|E3|Reported Event|OnabotulinumtoxinA Dose A|OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29530|NCT02261493|E2|Reported Event|OnabotulinumtoxinA Dose B|OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29531|NCT02261493|E1|Reported Event|Placebo (Normal Saline) Followed by OnabotulinumtoxinA Dose A|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
29532|NCT02261467|B3|Baseline|Total|Total of all reporting groups
29533|NCT02261467|B2|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29534|NCT02261467|B1|Baseline|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
29535|NCT02261467|P2|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29536|NCT02261467|P1|Participant Flow|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
29537|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29538|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
29539|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29540|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
29541|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29542|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
29543|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29544|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
29545|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29546|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
29547|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29776|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29548|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
29549|NCT02261467|O2|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29550|NCT02261467|O1|Outcome|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
29551|NCT02261467|E2|Reported Event|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
29552|NCT02261467|E1|Reported Event|Placebo Followed by OnabotulinumtoxinA in Period 2|Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
29553|NCT02261428|B3|Baseline|Total|Total of all reporting groups
29554|NCT02261428|B2|Baseline|Suction Catheter First, Then Catheter Tiemann|Participants first received nasotracheal suction with Suction catheter . After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
29555|NCT02261428|B1|Baseline|Catheter Tiemann First, Then Suction Catheter|Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
29556|NCT02261428|P2|Participant Flow|Suction Catheter First, Then Catheter Tiemann|Participants first received nasotracheal suction with suction catheter. After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
29557|NCT02261428|P1|Participant Flow|Catheter Tiemann First, Then Suction Catheter|Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
29558|NCT02261428|O2|Outcome|Suction Catheter|Presence of blood was found on Participants immediately after suctioning with Suction catheter
29559|NCT02261428|O1|Outcome|Catheter Tiemann|Presence of blood was found on Participants immediately after suctioning with catheter Tiemann
29560|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth Suction catheter
29561|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.
29562|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth Suction catheter
29563|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.
29564|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of heart rate recorded immediately after insertion to trachea wth Suction catheter
29565|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of heart rate recorded immediately after insertion to trachea wth catheter Tiemann.
29566|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth Suction catheter
29567|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth catheter Tiemann.
29568|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of time required to insert the trachea wth Suction catheter
29569|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of time required to insert the trachea wth catheter Tiemann.
29570|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of attempts made wth Suction catheter.
29571|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of attempts made wth catheter Tiemann.
29572|NCT02261428|E2|Reported Event|Suction Catheter|Participants received nasotracheal suction with Suction catheter
29573|NCT02261428|E1|Reported Event|Catheter Tiemann|Participants received nasotracheal suction with catheter Tiemann.
29574|NCT02260882|B3|Baseline|Total|Total of all reporting groups
29575|NCT02260882|B2|Baseline|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29576|NCT02260882|B1|Baseline|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29577|NCT02260882|P2|Participant Flow|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29578|NCT02260882|P1|Participant Flow|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29579|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29580|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29581|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29582|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29726|NCT02258412|E1|Reported Event|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
29584|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29585|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29586|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29587|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29588|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29589|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29590|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29591|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29592|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29593|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29594|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29595|NCT02260882|O1|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29596|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29597|NCT02260882|E2|Reported Event|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
29598|NCT02260882|E1|Reported Event|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
29599|NCT02260492|B4|Baseline|Total|Total of all reporting groups
29600|NCT02260492|B3|Baseline|Placebo|"Placebo (twice daily inhalation throughout the study)
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
29601|NCT02260492|B2|Baseline|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
29602|NCT02260492|B1|Baseline|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
29603|NCT02260492|P3|Participant Flow|Placebo|"Placebo (twice daily inhalation throughout the study)
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
29604|NCT02260492|P2|Participant Flow|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
29605|NCT02260492|P1|Participant Flow|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
29606|NCT02260492|O3|Outcome|Placebo|"Placebo (twice daily inhalation throughout the study)
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
29607|NCT02260492|O2|Outcome|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
29608|NCT02260492|O1|Outcome|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
29609|NCT02260492|O3|Outcome|Placebo|"Placebo (twice daily inhalation throughout the study)
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
29610|NCT02260492|O2|Outcome|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
29611|NCT02260492|O1|Outcome|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
29612|NCT02260492|O3|Outcome|Placebo|"Placebo (twice daily inhalation throughout the study)
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
29613|NCT02260492|O2|Outcome|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
29728|NCT02258334|B4|Baseline|Group 4|Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
47209|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
29614|NCT02260492|O1|Outcome|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
29615|NCT02260492|E3|Reported Event|Placebo|"Placebo (twice daily inhalation throughout the study)
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
29616|NCT02260492|E2|Reported Event|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
29617|NCT02260492|E1|Reported Event|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
29618|NCT02260440|B1|Baseline|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.
Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
29619|NCT02260440|P1|Participant Flow|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.
Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
29620|NCT02260440|O1|Outcome|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.
Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
29621|NCT02260440|O1|Outcome|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.
Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
29622|NCT02260440|O1|Outcome|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.
Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
29623|NCT02260440|E1|Reported Event|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.
Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
29624|NCT02260401|B3|Baseline|Total|Total of all reporting groups
29625|NCT02260401|B2|Baseline|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
29626|NCT02260401|B1|Baseline|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.
Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
29627|NCT02260401|P2|Participant Flow|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
29628|NCT02260401|P1|Participant Flow|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.
Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
29629|NCT02260401|O2|Outcome|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
29630|NCT02260401|O1|Outcome|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.
Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
29631|NCT02260401|E2|Reported Event|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
29632|NCT02260401|E1|Reported Event|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.
Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
29633|NCT02259608|B1|Baseline|yBCG|15 healthy volunteers that receive yBCG at baseline. There is no control group included in this trial.
29634|NCT02259608|P1|Participant Flow|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.
BCG vaccine SSI: BCG vaccination"
29635|NCT02259608|O1|Outcome|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.
BCG vaccine SSI: BCG vaccination"
29636|NCT02259608|O1|Outcome|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.
BCG vaccine SSI: BCG vaccination"
29637|NCT02259608|E1|Reported Event|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.
BCG vaccine SSI: BCG vaccination"
29638|NCT02259400|B3|Baseline|Total|Total of all reporting groups
29639|NCT02259400|B2|Baseline|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29640|NCT02259400|B1|Baseline|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29641|NCT02259400|P2|Participant Flow|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29642|NCT02259400|P1|Participant Flow|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29643|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29644|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29645|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29646|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29647|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29648|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29649|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29650|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29651|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29652|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29705|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
29727|NCT02258334|B5|Baseline|Total|Total of all reporting groups
29653|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29654|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29655|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29656|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29657|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29658|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29659|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29706|NCT02258477|O4|Outcome|10 cal Glucose Beverage|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
29878|NCT02256891|B1|Baseline|Double Row Only|Double Row
29660|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29661|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29662|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29663|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29664|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29665|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29666|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29707|NCT02258477|O3|Outcome|50 cal Glucose Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
29667|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29668|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29669|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29670|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29671|NCT02259400|E2|Reported Event|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.
BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
29672|NCT02259400|E1|Reported Event|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.
NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
29673|NCT02259348|B1|Baseline|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29674|NCT02259348|P1|Participant Flow|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29675|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29676|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29677|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29678|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29679|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29680|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29681|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29682|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29683|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29879|NCT02256891|P2|Participant Flow|Double Row With PRFM|"Double Row with PRFM
PRFM
Double Row"
29684|NCT02259348|E1|Reported Event|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.
Cyclophosphamide: Given intravenously (IV)
Fludarabine: Given IV
G-CSF: Given IV or subcutaneously (SQ)
Interleukin-2: Given SQ
Melphalan: Given IV
Thiotepa: Given IV
Rituximab: Given IV
Natural killer cell therapy: Given IV
T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.
CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
29685|NCT02258529|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29686|NCT02258529|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29687|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29688|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29689|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29690|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29691|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29692|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29693|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29694|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29695|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29696|NCT02258529|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
29697|NCT02258477|B1|Baseline|All Study Subjects|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Glucose: This is a randomized, double-blind cross-over pilot study involving 40 study subjects. We will compare the efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. After baseline data collection, eligible participants will be randomized into one of the four sequence group and receive a different beverage each week."
29698|NCT02258477|P4|Participant Flow|Sequence 4 (B-C-D-A)|Subjects in sequence 4 received 10 calorie beverage in week 1, 50 calorie beverage in week 2, 100 calorie beverage in week 3, and 0 calorie control beverage in week 4.
29699|NCT02258477|P3|Participant Flow|Sequence 3 (C-A-B-D)|Subjects in sequence 3 received 50 calorie beverage in week 1, 0 calorie control beverage in week 2, 20 calorie beverage in week 3, and 100 calorie beverage in week 4.
29700|NCT02258477|P2|Participant Flow|Sequence 2 (A-D-C-B)|Subjects in sequence 2 received 0 calorie control beverage in week 1, 100 calorie beverage in week 2, 50 calorie beverage in week 3, and 10 calorie beverage in week 4.
29701|NCT02258477|P1|Participant Flow|Sequence 1 (D-B-A-C)|Subjects assigned to sequence 1 received 100 calorie beverage in week 1, 10 calorie beverage in week 2, 0 calorie control beverage in week 3, and 50 calorie beverage in week 4.
29702|NCT02258477|O4|Outcome|10 cal Glucose Beverage|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
29703|NCT02258477|O3|Outcome|50 cal Glucose Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
29704|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
29880|NCT02256891|P1|Participant Flow|Double Row|"Double Row
Double Row"
29708|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
29709|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
29710|NCT02258477|O4|Outcome|10 Calorie|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
29711|NCT02258477|O3|Outcome|50 Calorie Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
29712|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
29713|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
29714|NCT02258477|E1|Reported Event|All Study Subjects|Subjects were randomized into four possible sequences: subjects assigned to sequence 1 received the control beverage first during week 1, then the 10 calorie beverage during week 2, then the 50 calorie beverage during week 3, and then the 100 calorie beverage during week 4. Subjects assigned to sequence 2 received received the 50 calorie beverage during week 1, then the 100 calorie beverage during week 2, then the control beverage during week 3, and then the 50 calorie beverage during week 4. Subejcts assigned to sequence 3 received the 50 calorie beverage during week 1, then the control beverage during week 2, then the 100 calorie beverage during week 3, and then the 10 calorie beverage during week 4. Subjects assigned to sequence 4 received the 100 calorie beverage during week 1, then the 50 calorie beverage during week 2, then the 10 calorie beverage during week 3, and then the control beverage during week 4.
29715|NCT02258412|B4|Baseline|Total|Total of all reporting groups
29716|NCT02258412|B3|Baseline|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
29717|NCT02258412|B2|Baseline|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
29718|NCT02258412|B1|Baseline|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
29719|NCT02258412|P3|Participant Flow|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
29720|NCT02258412|P2|Participant Flow|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
29721|NCT02258412|P1|Participant Flow|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
29722|NCT02258412|O2|Outcome|Hand Antiseptic With CHG and Alcohol|"Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.
hand antiseptic with CHG and alcohol: HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers."
29723|NCT02258412|O1|Outcome|Alcohol Hand Sanitizer Foam|"Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day.
Alcohol hand sanitizer foam: Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day"
29724|NCT02258412|E3|Reported Event|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
29725|NCT02258412|E2|Reported Event|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
29729|NCT02258334|B3|Baseline|Group 3|Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29730|NCT02258334|B2|Baseline|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
29731|NCT02258334|B1|Baseline|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29732|NCT02258334|P4|Participant Flow|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
29733|NCT02258334|P3|Participant Flow|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29734|NCT02258334|P2|Participant Flow|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
29735|NCT02258334|P1|Participant Flow|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29736|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
29737|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29738|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
29739|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29740|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
29741|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29742|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
29743|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29744|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
29745|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29746|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal of Fluzone Intradermal vaccine.
29747|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29748|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
29749|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29750|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
29751|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29752|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
29753|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29754|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
29755|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29756|NCT02258334|E4|Reported Event|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
29757|NCT02258334|E3|Reported Event|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29758|NCT02258334|E2|Reported Event|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
29759|NCT02258334|E1|Reported Event|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
29760|NCT02257918|B4|Baseline|Total|Total of all reporting groups
29761|NCT02257918|B3|Baseline|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29762|NCT02257918|B2|Baseline|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29763|NCT02257918|B1|Baseline|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29764|NCT02257918|P3|Participant Flow|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29765|NCT02257918|P2|Participant Flow|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29766|NCT02257918|P1|Participant Flow|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29767|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29768|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29769|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29770|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29771|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29772|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29773|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29774|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29775|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29777|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
51721|NCT02075632|B3|Baseline|Total|Total of all reporting groups
29778|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29779|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29780|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29781|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29782|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29783|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29784|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29785|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29786|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29787|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29788|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29789|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29790|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29791|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29792|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29793|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29794|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29795|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29796|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29797|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29798|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29799|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29800|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29801|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29802|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29803|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29804|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29805|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29806|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29807|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29808|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29809|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29810|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29811|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29812|NCT02257918|E3|Reported Event|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
29813|NCT02257918|E2|Reported Event|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
29814|NCT02257918|E1|Reported Event|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
29815|NCT02257684|B1|Baseline|Pegcrisantaspase|pegcrisantaspase
29816|NCT02257684|P1|Participant Flow|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
29817|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
29818|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
29819|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
29820|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
29821|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
29822|NCT02257684|E1|Reported Event|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
29823|NCT02257385|B3|Baseline|Total|Total of all reporting groups
29824|NCT02257385|B2|Baseline|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
29825|NCT02257385|B1|Baseline|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
29881|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM
PRFM
Double Row"
29882|NCT02256891|O1|Outcome|Double Row|"Double Row
Double Row"
29883|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM
PRFM
Double Row"
29884|NCT02256891|O1|Outcome|Double Row|"Double Row
Double Row"
29897|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM
PRFM
Double Row"
29826|NCT02257385|P2|Participant Flow|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
29827|NCT02257385|P1|Participant Flow|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
29828|NCT02257385|O2|Outcome|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
29829|NCT02257385|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
29830|NCT02257385|O2|Outcome|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
29831|NCT02257385|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
29832|NCT02257385|E2|Reported Event|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
29833|NCT02257385|E1|Reported Event|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
29834|NCT02257372|B3|Baseline|Total|Total of all reporting groups
29835|NCT02257372|B2|Baseline|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
29836|NCT02257372|B1|Baseline|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
29837|NCT02257372|P2|Participant Flow|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
29838|NCT02257372|P1|Participant Flow|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
29839|NCT02257372|O2|Outcome|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed
29840|NCT02257372|O1|Outcome|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
29841|NCT02257372|O2|Outcome|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed
29842|NCT02257372|O1|Outcome|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
29843|NCT02257372|E2|Reported Event|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
29885|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM
PRFM
Double Row"
29886|NCT02256891|O1|Outcome|Double Row|"Double Row
Double Row"
29844|NCT02257372|E1|Reported Event|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed
29845|NCT02256982|B3|Baseline|Total|Total of all reporting groups
29846|NCT02256982|B2|Baseline|Unresectable Disease|"Consent and Registration
3 cycles of gemcitabine + cisplatin
Evaluate for surgery* (weeks 10-15)
Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
Proceed to radiation therapy with protons or photons, determined by available resources
Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist
Gemcitabine
Cisplatin
Radiation: Radiation Therapy"
29847|NCT02256982|B1|Baseline|Resectable Disease|"Consent and Registration
3 cycles of gemcitabine + cisplatin
Evaluate for surgery* (weeks 10-15)
-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
Proceed to surgery
Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist
Gemcitabine
Cisplatin
Surgery: Surgical Resection and Lymphadenectomy"
29848|NCT02256982|P2|Participant Flow|Unresectable Disease|"Consent and Registration
3 cycles of gemcitabine + cisplatin
Evaluate for surgery* (weeks 10-15)
Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
Proceed to radiation therapy with protons or photons, determined by available resources
Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist
Gemcitabine
Cisplatin
Radiation: Radiation Therapy"
29849|NCT02256982|P1|Participant Flow|Resectable Disease|"Consent and Registration
3 cycles of gemcitabine + cisplatin
Evaluate for surgery* (weeks 10-15)
-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
Proceed to surgery
Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist
Gemcitabine
Cisplatin
Surgery: Surgical Resection and Lymphadenectomy"
29850|NCT02256982|O2|Outcome|Unresectable Disease|"Consent and Registration
3 cycles of gemcitabine + cisplatin
Evaluate for surgery* (weeks 10-15)
Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
Proceed to radiation therapy with protons or photons, determined by available resources
Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist
Gemcitabine
Cisplatin
Radiation: Radiation Therapy"
29851|NCT02256982|O1|Outcome|Resectable Disease|"Consent and Registration
3 cycles of gemcitabine + cisplatin
Evaluate for surgery* (weeks 10-15)
-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
Proceed to surgery
Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist
Gemcitabine
Cisplatin
Surgery: Surgical Resection and Lymphadenectomy"
29852|NCT02256982|E2|Reported Event|Unresectable Disease|"Consent and Registration
3 cycles of gemcitabine + cisplatin
Evaluate for surgery* (weeks 10-15)
Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
Proceed to radiation therapy with protons or photons, determined by available resources
Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist
Gemcitabine
Cisplatin
Radiation: Radiation Therapy"
29853|NCT02256982|E1|Reported Event|Resectable Disease|"Consent and Registration
3 cycles of gemcitabine + cisplatin
Evaluate for surgery* (weeks 10-15)
-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
Proceed to surgery
Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist
Gemcitabine
Cisplatin
Surgery: Surgical Resection and Lymphadenectomy"
29854|NCT02256969|B4|Baseline|Total|Total of all reporting groups
29855|NCT02256969|B3|Baseline|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
29856|NCT02256969|B2|Baseline|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29857|NCT02256969|B1|Baseline|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29858|NCT02256969|P3|Participant Flow|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
29859|NCT02256969|P2|Participant Flow|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29887|NCT02256891|O2|Outcome|Double Row With PRFM|"Double Row with PRFM
PRFM
Double Row"
29888|NCT02256891|O1|Outcome|Double Row|"Double Row
Double Row"
29860|NCT02256969|P1|Participant Flow|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29861|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
29862|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29863|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29864|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
29865|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29866|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29867|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
29868|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29869|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29870|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
29871|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29872|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29873|NCT02256969|E3|Reported Event|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
29874|NCT02256969|E2|Reported Event|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29875|NCT02256969|E1|Reported Event|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
29876|NCT02256891|B3|Baseline|Total|Total of all reporting groups
29877|NCT02256891|B2|Baseline|Double Row With PRFM|PRFM
29903|NCT02256553|B1|Baseline|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
29904|NCT02256553|P1|Participant Flow|MK-3641+MK-7243|Participants receive one MK-7243 tablet, sublingually (SL) once a day (QD) in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
29905|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
29906|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
29907|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
29908|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
29909|NCT02256553|E3|Reported Event|Period III: MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
29910|NCT02256553|E2|Reported Event|Period II: MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
29911|NCT02256553|E1|Reported Event|Period I: MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
29912|NCT02256488|B5|Baseline|Total|Total of all reporting groups
29913|NCT02256488|B4|Baseline|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
29914|NCT02256488|B3|Baseline|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
29915|NCT02256488|B2|Baseline|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
29916|NCT02256488|B1|Baseline|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
29917|NCT02256488|P4|Participant Flow|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
29918|NCT02256488|P3|Participant Flow|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
29919|NCT02256488|P2|Participant Flow|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
29920|NCT02256488|P1|Participant Flow|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
29921|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
29922|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
29923|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
29924|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
29925|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
29926|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
29927|NCT02256488|O3|Outcome|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
29928|NCT02256488|O2|Outcome|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
29929|NCT02256488|O1|Outcome|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
29930|NCT02256488|E3|Reported Event|Total|Total number of subjects
29931|NCT02256488|E2|Reported Event|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
29932|NCT02256488|E1|Reported Event|TIVc Pooled|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
29933|NCT02256436|B3|Baseline|Total|Total of all reporting groups
29934|NCT02256436|B2|Baseline|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29935|NCT02256436|B1|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29936|NCT02256436|P2|Participant Flow|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29937|NCT02256436|P1|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W).
29938|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29939|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29940|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29941|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29942|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29943|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29944|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29945|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29946|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29947|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29948|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29949|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29950|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29951|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29952|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29953|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29954|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29955|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29956|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29957|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29958|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29959|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29960|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29961|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29962|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29963|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29964|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29965|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29966|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29967|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29968|NCT02256436|O2|Outcome|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29969|NCT02256436|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29970|NCT02256436|E2|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg IV on Day 1 Q3W.
29971|NCT02256436|E1|Reported Event|Active Comparator|Participants received paclitaxel 175 mg/m^2 IV or docetaxel 75 mg/m^2 IV or vinflunine 320 mg/m^2 IV on Day 1 Q3W.
29972|NCT02256358|B3|Baseline|Total|Total of all reporting groups
29973|NCT02256358|B2|Baseline|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
29974|NCT02256358|B1|Baseline|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
29975|NCT02256358|P2|Participant Flow|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
29976|NCT02256358|P1|Participant Flow|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
29977|NCT02256358|O2|Outcome|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
29978|NCT02256358|O1|Outcome|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
29979|NCT02256358|E2|Reported Event|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
29980|NCT02256358|E1|Reported Event|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
30002|NCT02255565|P3|Participant Flow|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30095|NCT02255097|B1|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
29982|NCT02256072|B2|Baseline|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
29983|NCT02256072|B1|Baseline|Plan Your Lifespan Website|"Participants in the intervention arm will navigate Planyourlifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
29984|NCT02256072|P2|Participant Flow|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
29985|NCT02256072|P1|Participant Flow|Plan Your Lifespan Website|Participants in the intervention arm will navigate PlanYourLifespan.org.
29986|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
29987|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate the Plan Your Lifespan website, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas described below.
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making."
29988|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
29989|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
29990|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
29991|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
29992|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
29993|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
29994|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
29995|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
29996|NCT02256072|E2|Reported Event|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
29997|NCT02256072|E1|Reported Event|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. PlanYourLifespan.org is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
PlanYourLifespan.org: Participants in the intervention arm will navigate PlanYourLifespan.org, that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website."
29998|NCT02255565|B4|Baseline|Total|Total of all reporting groups
29999|NCT02255565|B3|Baseline|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30000|NCT02255565|B2|Baseline|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30001|NCT02255565|B1|Baseline|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30003|NCT02255565|P2|Participant Flow|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30004|NCT02255565|P1|Participant Flow|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30005|NCT02255565|O18|Outcome|Moderate Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30006|NCT02255565|O17|Outcome|Moderate Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30007|NCT02255565|O16|Outcome|Moderate Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30008|NCT02255565|O15|Outcome|Moderate Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30009|NCT02255565|O14|Outcome|Moderate Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30010|NCT02255565|O13|Outcome|Moderate Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30011|NCT02255565|O12|Outcome|Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30012|NCT02255565|O11|Outcome|Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30013|NCT02255565|O10|Outcome|Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30014|NCT02255565|O9|Outcome|Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30015|NCT02255565|O8|Outcome|Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30016|NCT02255565|O7|Outcome|Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30017|NCT02255565|O6|Outcome|Very Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30018|NCT02255565|O5|Outcome|Very Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30019|NCT02255565|O4|Outcome|Very Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30020|NCT02255565|O3|Outcome|Very Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30092|NCT02255149|P1|Participant Flow|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
30094|NCT02255149|E1|Reported Event|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
53695|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30021|NCT02255565|O2|Outcome|Very Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30022|NCT02255565|O1|Outcome|Very Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30023|NCT02255565|O18|Outcome|Moderate Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30024|NCT02255565|O17|Outcome|Moderate Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30025|NCT02255565|O16|Outcome|Moderate Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30026|NCT02255565|O15|Outcome|Moderate Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30027|NCT02255565|O14|Outcome|Moderate Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30028|NCT02255565|O13|Outcome|Moderate Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30029|NCT02255565|O12|Outcome|Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30030|NCT02255565|O11|Outcome|Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30031|NCT02255565|O10|Outcome|Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30032|NCT02255565|O9|Outcome|Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30033|NCT02255565|O8|Outcome|Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30034|NCT02255565|O7|Outcome|Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30035|NCT02255565|O6|Outcome|Very Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30036|NCT02255565|O5|Outcome|Very Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30037|NCT02255565|O4|Outcome|Very Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30038|NCT02255565|O3|Outcome|Very Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30039|NCT02255565|O2|Outcome|Very Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30040|NCT02255565|O1|Outcome|Very Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30041|NCT02255565|O18|Outcome|Moderate Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30042|NCT02255565|O17|Outcome|Moderate Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30043|NCT02255565|O16|Outcome|Moderate Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30044|NCT02255565|O15|Outcome|Moderate Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30045|NCT02255565|O14|Outcome|Moderate Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30046|NCT02255565|O13|Outcome|Moderate Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30047|NCT02255565|O12|Outcome|Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30048|NCT02255565|O11|Outcome|Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30049|NCT02255565|O10|Outcome|Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30050|NCT02255565|O9|Outcome|Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30051|NCT02255565|O8|Outcome|Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30052|NCT02255565|O7|Outcome|Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30053|NCT02255565|O6|Outcome|Very Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30054|NCT02255565|O5|Outcome|Very Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30055|NCT02255565|O4|Outcome|Very Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30056|NCT02255565|O3|Outcome|Very Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30057|NCT02255565|O2|Outcome|Very Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30093|NCT02255149|O1|Outcome|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
30058|NCT02255565|O1|Outcome|Very Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30059|NCT02255565|E3|Reported Event|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
30060|NCT02255565|E2|Reported Event|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
30061|NCT02255565|E1|Reported Event|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
30062|NCT02255279|B3|Baseline|Total|Total of all reporting groups
30063|NCT02255279|B2|Baseline|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
30064|NCT02255279|B1|Baseline|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
30065|NCT02255279|P2|Participant Flow|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
30066|NCT02255279|P1|Participant Flow|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
30067|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
30068|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
30069|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
30070|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
30071|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
30072|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
30073|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
30074|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
30075|NCT02255279|O2|Outcome|Non naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
30076|NCT02255279|O1|Outcome|Non naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
30077|NCT02255279|O2|Outcome|Naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
30078|NCT02255279|O1|Outcome|Naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
30079|NCT02255279|O2|Outcome|Non-naive_TIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
30080|NCT02255279|O1|Outcome|Non-naive_aTIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
30081|NCT02255279|O2|Outcome|Naive_TIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
30082|NCT02255279|O1|Outcome|Naive_aTIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
30083|NCT02255279|O2|Outcome|Non-naive_TIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of TIV to be administered.
30084|NCT02255279|O1|Outcome|Non-naive_aTIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of aTIV to be administered.
30085|NCT02255279|O2|Outcome|Naive_TIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of TIV to be administered.
30086|NCT02255279|O1|Outcome|Naive_aTIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of aTIV to be administered.
30087|NCT02255279|E4|Reported Event|Non-naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Non-naive).
30088|NCT02255279|E3|Reported Event|Non-naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Non-naive).
30089|NCT02255279|E2|Reported Event|Naive_TIV (6 Months to < 72 Months)|"A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Naive).
Enrolled subjects- 79 Exposed subjects- 78 Reason for discrepancy- Before vaccination one subject was withdrawn from study because of the suspected egg allergy."
30090|NCT02255279|E1|Reported Event|Naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Naive).
30091|NCT02255149|B1|Baseline|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
30096|NCT02255097|P1|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30097|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30098|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30099|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30100|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30101|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30102|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30103|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30104|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30105|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30106|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30107|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30108|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30109|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30110|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30111|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30112|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30113|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30114|NCT02255097|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30115|NCT02255097|E1|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 24 months
30116|NCT02254551|B1|Baseline|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.
Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
30117|NCT02254551|P1|Participant Flow|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.
Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
30118|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg for 21 days.
Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
30119|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg for 21 days.
Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
30120|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.
Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity"
30121|NCT02254551|E3|Reported Event|Cohort 3: LDE225 800mg/m^2|"Cohort 3 will receive LDE225 orally on a daily basis, at 800mg/m^2 every 21 days.
Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle."
30230|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
53696|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30122|NCT02254551|E2|Reported Event|Cohort 2: LDE225 600mg/m^2|Cohort 2 will receive LDE225 orally on a daily basis, at 600 mg every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
30123|NCT02254551|E1|Reported Event|Cohort 1: LDE225 400mg/m^2|"Cohort 1 will receive LDE225 orally on a daily basis, at 400mg/m^2 every 21 days.
Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle."
30124|NCT02254486|B3|Baseline|Total|Total of all reporting groups
30125|NCT02254486|B2|Baseline|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30126|NCT02254486|B1|Baseline|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30127|NCT02254486|P2|Participant Flow|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30128|NCT02254486|P1|Participant Flow|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30129|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30130|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30131|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30132|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30133|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30134|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30135|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30136|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30137|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30138|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30139|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30140|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30141|NCT02254486|E2|Reported Event|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30142|NCT02254486|E1|Reported Event|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
30143|NCT02254460|B1|Baseline|Overall|Micronutrient fortified nutritional beverage powder (test) and energy, iron and calcium equivalent beverage powder without micronutrient fortification (control), packed as 27 g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
30144|NCT02254460|P2|Participant Flow|Control Follwed by Test|Patients first received energy, iron and calcium equivalent beverage powder without micronutrient fortification (control) and then micronutrient fortified nutritional beverage powder (test), packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
30145|NCT02254460|P1|Participant Flow|Test Followed by Control|Patients first received micronutrient fortified nutritional beverage powder (test) and then energy, iron and calcium equivalent beverage powder without micronutrient fortification (control), packed as 27 grams (g) individual sachets, administered as a single serve in a total volume of 100 milliliters (mL) lukewarm milk for oral consumption. 1mL solution containing 3 milligrams/milliliters (mg/mL) of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage
30146|NCT02254460|O2|Outcome|Control|Energy, iron and calcium equivalent beverage powder without micronutrient fortification, packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption.1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (control). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
30147|NCT02254460|O1|Outcome|Test|Micronutrient fortified nutritional beverage powder, packed as 27g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (test). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
30231|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30232|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
53697|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30148|NCT02254460|E2|Reported Event|Control|Energy, iron and calcium equivalent beverage powder without micronutrient fortification, packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe, 58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (control). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
30149|NCT02254460|E1|Reported Event|Test|Micronutrient fortified nutritional beverage powder, packed as 27g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (test). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
30150|NCT02254252|B3|Baseline|Total|Total of all reporting groups
30151|NCT02254252|B2|Baseline|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)"
30152|NCT02254252|B1|Baseline|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
30153|NCT02254252|P2|Participant Flow|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)"
30154|NCT02254252|P1|Participant Flow|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
30155|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)"
30156|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
30157|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)"
30158|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
30159|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)"
30160|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
30161|NCT02254252|E2|Reported Event|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day)"
30162|NCT02254252|E1|Reported Event|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
30163|NCT02253654|B3|Baseline|Total|Total of all reporting groups
30164|NCT02253654|B2|Baseline|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
30165|NCT02253654|B1|Baseline|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
30166|NCT02253654|P2|Participant Flow|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
30167|NCT02253654|P1|Participant Flow|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
30227|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30168|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
30169|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
30170|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
30171|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
30172|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
30173|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
30174|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
30175|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
30176|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
30177|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
30178|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
30179|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
30180|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
30181|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
30228|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30229|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30182|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
30183|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
30184|NCT02253654|E2|Reported Event|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
30185|NCT02253654|E1|Reported Event|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
30186|NCT02253173|B5|Baseline|Total|Total of all reporting groups
30187|NCT02253173|B4|Baseline|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30188|NCT02253173|B3|Baseline|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30189|NCT02253173|B2|Baseline|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30190|NCT02253173|B1|Baseline|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30191|NCT02253173|P4|Participant Flow|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30192|NCT02253173|P3|Participant Flow|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30193|NCT02253173|P2|Participant Flow|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30194|NCT02253173|P1|Participant Flow|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30195|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30196|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30197|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30198|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30199|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30200|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30201|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30202|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30203|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30204|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30205|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30206|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30207|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30208|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30209|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30210|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30211|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30212|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30213|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30214|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30215|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30216|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30217|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30218|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30219|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30220|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30221|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30222|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30223|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30224|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30225|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30226|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30233|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30234|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30235|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30236|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30237|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30238|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30239|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30240|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30241|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30242|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30243|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30244|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30245|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30246|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30247|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30248|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30249|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30250|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30251|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30252|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30253|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30254|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30255|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30256|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30257|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30258|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30259|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30260|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30261|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30262|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30263|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30264|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30265|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30266|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30267|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30268|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30269|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30270|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30271|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30272|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30273|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30274|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30275|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30276|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30277|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30278|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30279|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30280|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30281|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30282|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30283|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30284|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30285|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
41127|NCT02153489|E1|Reported Event|Aclidinium|Aclidinium 400 μg BID
30286|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30287|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30288|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30289|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30290|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30291|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30292|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30293|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30294|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30295|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30296|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30297|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30298|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30299|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30300|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30301|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30302|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30303|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30304|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30305|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30306|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30307|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30308|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30309|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30310|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30311|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30312|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30313|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30314|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30315|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30316|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30317|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30318|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30319|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30320|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30321|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30322|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30323|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30324|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30325|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30326|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30327|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30328|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30329|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30330|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30331|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30332|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30333|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30334|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30335|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30336|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30337|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30338|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30339|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30340|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30341|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
41128|NCT02153398|B6|Baseline|Total|Total of all reporting groups
30342|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30343|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30344|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30345|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30346|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30347|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30348|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30349|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30350|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30351|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30352|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30353|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30354|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30355|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30356|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30357|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30358|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30359|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30360|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30361|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30362|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30363|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule
Placebo"
30364|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule
Estradiol"
30365|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule
Estradiol"
30366|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule
Estradiol"
30367|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30368|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30369|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30370|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30371|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30372|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30373|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30374|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30375|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30376|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30377|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30378|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30379|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30380|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30381|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30382|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30383|NCT02253173|E4|Reported Event|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30384|NCT02253173|E3|Reported Event|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30385|NCT02253173|E2|Reported Event|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30386|NCT02253173|E1|Reported Event|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
30387|NCT02253160|B4|Baseline|Total|Total of all reporting groups
30471|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30472|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30446|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30388|NCT02253160|B3|Baseline|COBE Spectra MNC First, Then Spectra Optia CMNC|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30389|NCT02253160|B2|Baseline|Spectra Optia CMNC First, Then COBE Spectra MNC|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30390|NCT02253160|B1|Baseline|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
30391|NCT02253160|P3|Participant Flow|COBE Spectra MNC First, Then Spectra Optia CMNC|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30392|NCT02253160|P2|Participant Flow|Spectra Optia CMNC First, Then COBE Spectra MNC|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30393|NCT02253160|P1|Participant Flow|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
30394|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30395|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30396|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30443|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30697|NCT02248818|B4|Baseline|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30397|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30398|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30399|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30400|NCT02253160|O2|Outcome|COBE Spectra|Subjects who received an CMNC collection using the COBE Spectra
30401|NCT02253160|O1|Outcome|Spectra Optia|Subjects who received an CMNC collection using the Spectra Optia
30402|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30403|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30404|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30405|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30444|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30445|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16
30406|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30407|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30408|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30409|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30410|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30411|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30412|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30413|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30414|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30415|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30416|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30417|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30418|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30419|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30420|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30421|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30422|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30423|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
30424|NCT02253160|E4|Reported Event|Follow up|Subjects who completed cross-over design and were followed for at least 1 day.
30425|NCT02253160|E3|Reported Event|COBE Spectra|Subjects who received COBE Spectra MNC collection procedure.
30426|NCT02253160|E2|Reported Event|Spectra Optia|Subject who received Spectra Optia CMNC collection procedure.
30427|NCT02253160|E1|Reported Event|Pre-collection|Subjects screened and received G-CSF.
30428|NCT02252965|B3|Baseline|Total|Total of all reporting groups
30429|NCT02252965|B2|Baseline|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30430|NCT02252965|B1|Baseline|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30431|NCT02252965|P2|Participant Flow|Metformin XR|Subjects received Metformin Extended Release (XR) tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30432|NCT02252965|P1|Participant Flow|Metformin IR|Subjects received Metformin Immediate Release (IR) tablets, orally once daily (QD) at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30433|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30434|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30435|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30436|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30437|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30438|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30439|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30440|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30441|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30442|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30447|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30448|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30449|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16
30450|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30451|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30452|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30453|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30454|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30455|NCT02252965|E3|Reported Event|Metformin IR to XR|Subjects who received Metformin IR tablets initially, but were shifted to Metformin XR group due to intolerance to Metformin IR.
30456|NCT02252965|E2|Reported Event|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
30457|NCT02252965|E1|Reported Event|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
30458|NCT02252744|B1|Baseline|RA Patients|Adult patients diagnosed with rheumatoid arthritis
30459|NCT02252744|P1|Participant Flow|RA Patients|Adult patients diagnosed with rheumatoid arthritis
30460|NCT02252744|O1|Outcome|RA Patients|Adult patients diagnosed with rheumatoid arthritis
30461|NCT02252744|E1|Reported Event|RA Patients|Adult patients diagnosed with rheumatoid arthritis
30462|NCT02252718|B1|Baseline|Children 2-18 Months of Age|Children between 2 and 18 months of age who were not toilet trained
30463|NCT02252718|P1|Participant Flow|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw
Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
30464|NCT02252718|O1|Outcome|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw
Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
30465|NCT02252718|E1|Reported Event|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw
Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
30466|NCT02252445|B3|Baseline|Total|Total of all reporting groups
30467|NCT02252445|B2|Baseline|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30468|NCT02252445|B1|Baseline|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30469|NCT02252445|P2|Participant Flow|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30470|NCT02252445|P1|Participant Flow|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30473|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30474|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30475|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30476|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30477|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30478|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30479|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30480|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30481|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30482|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30483|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30484|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30485|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30486|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30487|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30488|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30489|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30490|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30491|NCT02252445|E2|Reported Event|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered."
30492|NCT02252445|E1|Reported Event|Propofol|"Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered."
30493|NCT02252354|B3|Baseline|Total|Total of all reporting groups
30494|NCT02252354|B2|Baseline|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30495|NCT02252354|B1|Baseline|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30496|NCT02252354|P2|Participant Flow|Part 2: TAK-385 + [14C]-TAK-385|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30497|NCT02252354|P1|Participant Flow|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30498|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30499|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30500|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30501|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30502|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30503|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30504|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30505|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30506|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30507|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30508|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30509|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30510|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30511|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30512|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30513|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30514|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30515|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30516|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30517|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30518|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30519|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30520|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
41439|NCT02151994|O5|Outcome|100 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
30521|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30595|NCT02251652|O2|Outcome|Cryotherapy Alone|"Cryotherapy only
Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
30522|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30523|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30524|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30525|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30526|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30527|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30528|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30529|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30530|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30531|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30532|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30533|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30534|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30535|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30536|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30537|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30538|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30539|NCT02252354|E2|Reported Event|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
30540|NCT02252354|E1|Reported Event|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
30541|NCT02252133|B1|Baseline|Overall|DAILIES TOTAL1® and 1-Day Acuvue® TruEye® contact lenses worn during Period 1 and Period 2 in a crossover assignment.
30542|NCT02252133|P2|Participant Flow|1DAVTE, Then DT1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
30543|NCT02252133|P1|Participant Flow|DT1, Then 1DAVTE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
30544|NCT02252133|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn during Period 1 or Period 2 for 7 days.
30545|NCT02252133|O1|Outcome|Dailies Total 1|Delefilcon A contact lenses during Period 1 or Period 2 for 7 days.
30546|NCT02252133|E2|Reported Event|1DAVTE|All subjects who wore narafilcon A contact lenses
30547|NCT02252133|E1|Reported Event|Dailies Total 1|All subjects who wore delefilcon A contact lenses
30548|NCT02252016|B3|Baseline|Total|Total of all reporting groups
30549|NCT02252016|B2|Baseline|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
30550|NCT02252016|B1|Baseline|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
30551|NCT02252016|P2|Participant Flow|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
30552|NCT02252016|P1|Participant Flow|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
30553|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
30554|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
30555|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
30556|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
30557|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
30558|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
30559|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
41440|NCT02151994|O4|Outcome|50 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
30700|NCT02248818|B1|Baseline|AZD8108 20 mg - SAD|AZD8108 20 mg SAD, Cohort 1
30701|NCT02248818|P9|Participant Flow|Screen|Screen - no treatment
30560|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
30561|NCT02252016|E2|Reported Event|Deferred Treatment: Placebo Phase|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
30562|NCT02252016|E1|Reported Event|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
30563|NCT02251912|B3|Baseline|Total|Total of all reporting groups
30564|NCT02251912|B2|Baseline|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
30565|NCT02251912|B1|Baseline|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
30566|NCT02251912|P2|Participant Flow|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
30567|NCT02251912|P1|Participant Flow|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
30568|NCT02251912|O2|Outcome|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
30569|NCT02251912|O1|Outcome|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
30570|NCT02251912|O2|Outcome|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
30571|NCT02251912|O1|Outcome|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
30572|NCT02251912|O2|Outcome|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
30573|NCT02251912|O1|Outcome|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
30574|NCT02251912|E2|Reported Event|Control|"Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks"
30575|NCT02251912|E1|Reported Event|Active|"Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks"
30576|NCT02251886|B5|Baseline|Total|Total of all reporting groups
30577|NCT02251886|B4|Baseline|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
30578|NCT02251886|B3|Baseline|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
30579|NCT02251886|B2|Baseline|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae
Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
30580|NCT02251886|B1|Baseline|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae
Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
30581|NCT02251886|P4|Participant Flow|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
30582|NCT02251886|P3|Participant Flow|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
30583|NCT02251886|P2|Participant Flow|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae
Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
30584|NCT02251886|P1|Participant Flow|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae
Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
30585|NCT02251886|O4|Outcome|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
30586|NCT02251886|O3|Outcome|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
30587|NCT02251886|O2|Outcome|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae
Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
30588|NCT02251886|O1|Outcome|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae
Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
30589|NCT02251886|E4|Reported Event|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
30590|NCT02251886|E3|Reported Event|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
30591|NCT02251886|E2|Reported Event|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae
Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
30592|NCT02251886|E1|Reported Event|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae
Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
30593|NCT02251652|B1|Baseline|Actinic Keratosis|Each subject is its own control - left dorsal hand compared to right dorsal hand
30594|NCT02251652|P1|Participant Flow|Actinic Keratosis|Each subject is its own control - left dorsal hand compared to right dorsal hand
30596|NCT02251652|O1|Outcome|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel
Ingenol Mebutate: Ingenol mebutate 0.05% gel
Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
30597|NCT02251652|O2|Outcome|Cryotherapy Alone|"Cryotherapy only
Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
30598|NCT02251652|O1|Outcome|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel
Ingenol Mebutate: Ingenol mebutate 0.05% gel
Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
30599|NCT02251652|O2|Outcome|Cryotherapy Alone|"Cryotherapy only
Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
30600|NCT02251652|O1|Outcome|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel
Ingenol Mebutate: Ingenol mebutate 0.05% gel
Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
30601|NCT02251652|E2|Reported Event|Cryotherapy Alone|"Cryotherapy only
Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
30602|NCT02251652|E1|Reported Event|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel
Ingenol Mebutate: Ingenol mebutate 0.05% gel
Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
30603|NCT02251613|B1|Baseline|Overall|Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
30604|NCT02251613|P1|Participant Flow|Overall|Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
30605|NCT02251613|O2|Outcome|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
30606|NCT02251613|O1|Outcome|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
30607|NCT02251613|O2|Outcome|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
30608|NCT02251613|O1|Outcome|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
30609|NCT02251613|E2|Reported Event|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
30610|NCT02251613|E1|Reported Event|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
30611|NCT02251561|B1|Baseline|FID 109182/Opti-Free Plus|Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
30612|NCT02251561|P1|Participant Flow|FID 109182/Opti-Free Plus|Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
30613|NCT02251561|O2|Outcome|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
30614|NCT02251561|O1|Outcome|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
30615|NCT02251561|O2|Outcome|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
30616|NCT02251561|O1|Outcome|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
30617|NCT02251561|E2|Reported Event|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
30618|NCT02251561|E1|Reported Event|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
30619|NCT02250807|B1|Baseline|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
30620|NCT02250807|P1|Participant Flow|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
30621|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
30622|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
30623|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
30624|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
30625|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
30626|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
30627|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
30628|NCT02250807|E1|Reported Event|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
30629|NCT02250703|B3|Baseline|Total|Total of all reporting groups
30630|NCT02250703|B2|Baseline|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
30631|NCT02250703|B1|Baseline|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
30632|NCT02250703|P2|Participant Flow|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
30698|NCT02248818|B3|Baseline|AZD8108 95 mg - SAD|AZD8108 95 mg SAD, Cohort 3
30702|NCT02248818|P8|Participant Flow|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
53789|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
30633|NCT02250703|P1|Participant Flow|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
30634|NCT02250703|O2|Outcome|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
30635|NCT02250703|O1|Outcome|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
30636|NCT02250703|O2|Outcome|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
30637|NCT02250703|O1|Outcome|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
30638|NCT02250703|O2|Outcome|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
30639|NCT02250703|O1|Outcome|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
30640|NCT02250703|O2|Outcome|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
30641|NCT02250703|O1|Outcome|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
30642|NCT02250703|E2|Reported Event|Dexmedetomidine|"In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg"
30643|NCT02250703|E1|Reported Event|Midazolam|"In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg"
30644|NCT02250274|B3|Baseline|Total|Total of all reporting groups
30645|NCT02250274|B2|Baseline|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
30646|NCT02250274|B1|Baseline|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
30647|NCT02250274|P2|Participant Flow|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
30648|NCT02250274|P1|Participant Flow|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
30649|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
30665|NCT02249728|O1|Outcome|Part One Absolute Bioavailability|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
30699|NCT02248818|B2|Baseline|AZD8108 60 mg - SAD|AZD8108 60 mg SAD, Cohort 2
30650|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
30651|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
30652|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
30653|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
30654|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
30655|NCT02250274|E2|Reported Event|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
30656|NCT02250274|E1|Reported Event|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
30657|NCT02249728|B1|Baseline|All Study Participants|In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.
30658|NCT02249728|P1|Participant Flow|All Study Participants|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
30659|NCT02249728|O1|Outcome|Part Two Radiolabelle AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
30660|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
30661|NCT02249728|O1|Outcome|All Study Participants|In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.
30662|NCT02249728|O1|Outcome|Part One Absolute Bioavailability|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
30663|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
30664|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
30666|NCT02249728|E1|Reported Event|All Study Participants|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
30667|NCT02249104|B1|Baseline|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily
Cetaphil Acne Regimen:
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application
Cetaphil® DermaControl™ Foam Wash, at least twice daily
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
30668|NCT02249104|P1|Participant Flow|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily
Cetaphil Acne Regimen:
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application
Cetaphil® DermaControl™ Foam Wash, at least twice daily
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
30669|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily
Cetaphil Acne Regimen:
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application
Cetaphil® DermaControl™ Foam Wash, at least twice daily
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
30670|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily
Cetaphil Acne Regimen:
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application
Cetaphil® DermaControl™ Foam Wash, at least twice daily
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
30671|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily
Cetaphil Acne Regimen:
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application
Cetaphil® DermaControl™ Foam Wash, at least twice daily
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
30672|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily
Cetaphil Acne Regimen:
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application
Cetaphil® DermaControl™ Foam Wash, at least twice daily
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
30673|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily
Cetaphil Acne Regimen:
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application
Cetaphil® DermaControl™ Foam Wash, at least twice daily
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
30674|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily
Cetaphil Acne Regimen:
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application
Cetaphil® DermaControl™ Foam Wash, at least twice daily
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
30675|NCT02249104|E1|Reported Event|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily
Cetaphil Acne Regimen:
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application
Cetaphil® DermaControl™ Foam Wash, at least twice daily
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
30676|NCT02249052|B1|Baseline|AA4500 and Placebo|"single injection of 0.58 mg study drug and placebo
Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously"
30677|NCT02249052|P1|Participant Flow|AA4500 and Placebo|"Each subject received a single injection of 1 mL containing 0.58 mg AA4500 in one lipoma and a single injection of 1 mL placebo in another lipoma
Lipoma #1 was randomized to AA4500 or placebo with Lipoma #2 receiving the alternate intervention"
30678|NCT02249052|O2|Outcome|Placebo|Each participant received a single injection of 1 mL placebo
30679|NCT02249052|O1|Outcome|AA4500|Each participants received a single injection of 1 mL containing 0.58 mg AA4500
30680|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
30681|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
30682|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
30683|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
30684|NCT02249052|O2|Outcome|Placebo|Each participant received a single injection of 1 mL placebo
30685|NCT02249052|O1|Outcome|AA4500|Each participants received a single injection of 1 mL containing 0.58 mg AA4500
30686|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
30687|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
30688|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
30689|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
30690|NCT02249052|E2|Reported Event|Placebo|"single injection of placebo
placebo: Placebo"
30691|NCT02249052|E1|Reported Event|AA4500|"single injection of 0.58 mg study drug
AA4500: Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously"
30692|NCT02248818|B9|Baseline|Total|Total of all reporting groups
30693|NCT02248818|B8|Baseline|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30694|NCT02248818|B7|Baseline|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30695|NCT02248818|B6|Baseline|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30696|NCT02248818|B5|Baseline|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
41441|NCT02151994|O3|Outcome|25 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
30705|NCT02248818|P5|Participant Flow|AZD8108 50 mg|AZD8108 50 mg MAD, Cohort 5
30706|NCT02248818|P4|Participant Flow|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30707|NCT02248818|P3|Participant Flow|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30708|NCT02248818|P2|Participant Flow|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30709|NCT02248818|P1|Participant Flow|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30710|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30711|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30712|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30713|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30714|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30715|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30716|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30717|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30718|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30719|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30720|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30721|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30722|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30723|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30724|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30725|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30726|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30727|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30728|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30729|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30730|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30731|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30732|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30733|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30734|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30735|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30736|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30737|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30738|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30739|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30740|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30741|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30742|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30743|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30744|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30745|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30746|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30747|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30748|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30749|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30750|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30751|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30752|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30753|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30754|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30755|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30756|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30757|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30758|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30759|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30760|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30761|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30762|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30763|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30764|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30765|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30766|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30767|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30768|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30769|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30770|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30771|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30772|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30773|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30774|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30775|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30776|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30777|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30778|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30779|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30780|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30781|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30782|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30783|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30784|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30785|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30786|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30787|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30788|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30789|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30790|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30791|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30792|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30793|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30794|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30795|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30796|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30797|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30798|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30799|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30800|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30801|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30802|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30803|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30804|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30805|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30806|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30807|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30808|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30809|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30810|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30811|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30812|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30813|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30814|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30815|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30816|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30817|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30818|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30819|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30820|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30821|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30822|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30823|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30824|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30825|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30826|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30827|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30828|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30829|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30830|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30831|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30832|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30833|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30834|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30835|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30836|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30837|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30838|NCT02248818|E8|Reported Event|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
30839|NCT02248818|E7|Reported Event|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
30840|NCT02248818|E6|Reported Event|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
30841|NCT02248818|E5|Reported Event|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
30842|NCT02248818|E4|Reported Event|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
30843|NCT02248818|E3|Reported Event|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
30844|NCT02248818|E2|Reported Event|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
30845|NCT02248818|E1|Reported Event|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
30846|NCT02248766|B1|Baseline|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens
somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
30847|NCT02248766|P1|Participant Flow|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens
somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
31072|NCT02246673|O1|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
30848|NCT02248766|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30849|NCT02248766|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30850|NCT02248766|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30851|NCT02248766|O1|Outcome|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
30852|NCT02248766|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30853|NCT02248766|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30854|NCT02248766|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30855|NCT02248766|O1|Outcome|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
30856|NCT02248766|E2|Reported Event|Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
30857|NCT02248766|E1|Reported Event|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
30858|NCT02248727|B1|Baseline|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens"
30859|NCT02248727|P1|Participant Flow|Enfilcon A / Somofilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30860|NCT02248727|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30861|NCT02248727|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30862|NCT02248727|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30863|NCT02248727|O1|Outcome|Enfilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30864|NCT02248727|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30865|NCT02248727|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30866|NCT02248727|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30867|NCT02248727|O1|Outcome|Enfilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
30868|NCT02248727|E1|Reported Event|Enfilcon A to Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens"
30869|NCT02248675|B3|Baseline|Total|Total of all reporting groups
30870|NCT02248675|B2|Baseline|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30871|NCT02248675|B1|Baseline|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30872|NCT02248675|P2|Participant Flow|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
31067|NCT02246673|O6|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
30903|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30904|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
55079|NCT02050334|B3|Baseline|Total|Total of all reporting groups
30873|NCT02248675|P1|Participant Flow|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30874|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30875|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30876|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30877|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30878|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30879|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30880|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30899|NCT02248480|B1|Baseline|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30900|NCT02248480|P2|Participant Flow|Placebo|Placebo administered orally once a day for 15 weeks.
30901|NCT02248480|P1|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30902|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30881|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30882|NCT02248675|E2|Reported Event|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30883|NCT02248675|E1|Reported Event|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.
TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
30884|NCT02248558|B3|Baseline|Total|Total of all reporting groups
30885|NCT02248558|B2|Baseline|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
30886|NCT02248558|B1|Baseline|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
30887|NCT02248558|P2|Participant Flow|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
30888|NCT02248558|P1|Participant Flow|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
30889|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.
In the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV."
30890|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.
111 of 317 (35%) in the health marketing arm reported testing for HIV"
30891|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
30892|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
30893|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.
In the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV."
30894|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.
111 of 317 (35%) in the health marketing arm reported testing for HIV"
30895|NCT02248558|E2|Reported Event|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
30896|NCT02248558|E1|Reported Event|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
30897|NCT02248480|B3|Baseline|Total|Total of all reporting groups
30898|NCT02248480|B2|Baseline|Placebo|Placebo administered orally once a day for 15 weeks.
30905|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30906|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30907|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30908|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30909|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30910|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30911|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30912|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30913|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30914|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30915|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30916|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30917|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30918|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30919|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30920|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30921|NCT02248480|O1|Outcome|Duloxetine|"Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
Duloxetine: Administered orally"
30922|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30923|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30924|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30925|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30926|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30927|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30928|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30929|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30930|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30931|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30932|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30933|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30934|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
30935|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30936|NCT02248480|E2|Reported Event|Placebo|Placebo administered orally once a day for 15 weeks.
30937|NCT02248480|E1|Reported Event|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
30938|NCT02248246|B1|Baseline|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection
Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:
Inferior mesenteric artery (IMA)
Inferior mesenteric vein (IMV) (if identified)"
30939|NCT02248246|P1|Participant Flow|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection
Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:
Inferior mesenteric artery (IMA)
Inferior mesenteric vein (IMV) (if identified)"
30940|NCT02248246|O1|Outcome|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection
Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:
Inferior mesenteric artery (IMA)
Inferior mesenteric vein (IMV) (if identified)"
41442|NCT02151994|O2|Outcome|5 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
30941|NCT02248246|O1|Outcome|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection
Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:
Inferior mesenteric artery (IMA)
Inferior mesenteric vein (IMV) (if identified)"
30942|NCT02248246|E1|Reported Event|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection
Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:
Inferior mesenteric artery (IMA)
Inferior mesenteric vein (IMV) (if identified)"
30943|NCT02248103|B3|Baseline|Total|Total of all reporting groups
30944|NCT02248103|B2|Baseline|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane
Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
30945|NCT02248103|B1|Baseline|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.
Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
30946|NCT02248103|P2|Participant Flow|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane
Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
30947|NCT02248103|P1|Participant Flow|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.
Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
30948|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane
Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
30949|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.
Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
30950|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane
Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
30951|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.
Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
30952|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane
Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
30953|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.
Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
30954|NCT02248103|E2|Reported Event|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane
Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
30955|NCT02248103|E1|Reported Event|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.
Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
30956|NCT02247960|B3|Baseline|Total|Total of all reporting groups
30957|NCT02247960|B2|Baseline|No Antibiotic|No Antibiotic
30958|NCT02247960|B1|Baseline|Ciprofloxacin|"Antibiotic
Ciprofloxacin"
30959|NCT02247960|P2|Participant Flow|No Antibiotic|No Antibiotic
30960|NCT02247960|P1|Participant Flow|Ciprofloxacin|"Antibiotic
Ciprofloxacin"
30961|NCT02247960|O2|Outcome|No Antibiotic|No Antibiotic
30962|NCT02247960|O1|Outcome|Ciprofloxacin|"Antibiotic
Ciprofloxacin"
30963|NCT02247960|O2|Outcome|No Antibiotic|No Antibiotic
30964|NCT02247960|O1|Outcome|Ciprofloxacin|"Antibiotic
Ciprofloxacin"
30965|NCT02247960|O2|Outcome|No Antibiotic|No Antibiotic
30966|NCT02247960|O1|Outcome|Ciprofloxacin|"Antibiotic
Ciprofloxacin"
30967|NCT02247960|E2|Reported Event|No Antibiotic|No Antibiotic
30968|NCT02247960|E1|Reported Event|Ciprofloxacin|"Antibiotic
Ciprofloxacin"
30969|NCT02247765|B1|Baseline|no Treatment|
30970|NCT02247765|P1|Participant Flow|USB Pulse Oximetry Monitor Interface Cable|"Additional interventions include the following: Radial Arterial Line placement involves introduction of a standard arterial catheter or angiocath into the radial artery. Since the arterial catheter is placed into the artery using a needle, there will be mild to moderate discomfort. The total amount of blood drawn during the procedure is less than 100cc.
Additionally, subjects are asked to perform motions with their hand. Standard motions include tapping and rubbing at aperiodic intervals with amplitudes of 1‐2 cm and 1‐4 Hz with a random variation in frequency. The subject is instructed to tap (or rub) with finger tips to maintain consistency of area of effect on the pressure pad and to prevent resting hand on pressure pad between motions so that only qualified taps are recorded by the pressure pad system. Each plateau will have both an interval of tapping and rubbing."
30971|NCT02247765|O1|Outcome|no Treatment|
30972|NCT02247765|O1|Outcome|no Treatment|
30973|NCT02247765|E1|Reported Event|no Treatment|
30974|NCT02247401|B4|Baseline|Total|Total of all reporting groups
30975|NCT02247401|B3|Baseline|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30976|NCT02247401|B2|Baseline|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30977|NCT02247401|B1|Baseline|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
30978|NCT02247401|P3|Participant Flow|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30979|NCT02247401|P2|Participant Flow|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30980|NCT02247401|P1|Participant Flow|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
31071|NCT02246673|O2|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
30981|NCT02247401|O3|Outcome|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30982|NCT02247401|O2|Outcome|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30983|NCT02247401|O1|Outcome|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
30984|NCT02247401|O3|Outcome|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30985|NCT02247401|O2|Outcome|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30986|NCT02247401|O1|Outcome|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
30987|NCT02247401|O3|Outcome|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30988|NCT02247401|O2|Outcome|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30989|NCT02247401|O1|Outcome|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
30990|NCT02247401|O3|Outcome|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30991|NCT02247401|O2|Outcome|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30992|NCT02247401|O1|Outcome|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
30993|NCT02247401|E3|Reported Event|Arm C|ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30994|NCT02247401|E2|Reported Event|Arm B|ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
30995|NCT02247401|E1|Reported Event|Arm A|ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
30996|NCT02247011|B3|Baseline|Total|Total of all reporting groups
30997|NCT02247011|B2|Baseline|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
30998|NCT02247011|B1|Baseline|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
30999|NCT02247011|P1|Participant Flow|Overall Subjects|In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants.
31000|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31001|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31002|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31003|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31004|NCT02247011|O2|Outcome|Non-fracture Group|Fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31005|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31006|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31007|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31065|NCT02246673|O8|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
31066|NCT02246673|O7|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
31008|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31009|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31010|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31011|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31012|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31013|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
31014|NCT02247011|E1|Reported Event|Overall Subjects|In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants. Of all these participants, 975 participants finished the questionnaire and for 961 of them, the spine x-ray was of enough quality to determine if there is vertebral fracture.
31015|NCT02246673|B6|Baseline|Total|Total of all reporting groups
31016|NCT02246673|B5|Baseline|Cohort 5|
31017|NCT02246673|B4|Baseline|Cohort 4|
31018|NCT02246673|B3|Baseline|Cohort 3|
31019|NCT02246673|B2|Baseline|Cohort 2|
31020|NCT02246673|B1|Baseline|Cohort 1|
31021|NCT02246673|P5|Participant Flow|Cohort 5|(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 20 mg + Febuxostat 40 mg)
31022|NCT02246673|P4|Participant Flow|Cohort 4|(RDEA3170 2.5 mg + Febuxostat 40 mg; RDEA3170 2.5 mg + Febuxostat 80 mg)
31023|NCT02246673|P3|Participant Flow|Cohort 3|(RDEA3170 5 mg + Febuxostat 40 mg; RDEA3170 5 mg + Febuxostat 80 mg)
31024|NCT02246673|P2|Participant Flow|Cohort 2|(RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 80 mg)
31025|NCT02246673|P1|Participant Flow|Cohort 1|(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 10 mg + Febuxostat 80 mg)
31026|NCT02246673|O11|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
31027|NCT02246673|O10|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
31028|NCT02246673|O9|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
31029|NCT02246673|O8|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
31030|NCT02246673|O7|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
31031|NCT02246673|O6|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
31032|NCT02246673|O5|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
31033|NCT02246673|O4|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
31034|NCT02246673|O3|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
31035|NCT02246673|O2|Outcome|Febuxostat 80 mg|Overall (Cohorts 1 through 5)
31036|NCT02246673|O1|Outcome|Febuxostat 40 mg|Overall (Cohorts 1 through 5)
31037|NCT02246673|O9|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
31038|NCT02246673|O8|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
31039|NCT02246673|O7|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
31040|NCT02246673|O6|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
31041|NCT02246673|O5|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
31042|NCT02246673|O4|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
31043|NCT02246673|O3|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
31044|NCT02246673|O2|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
31045|NCT02246673|O1|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
31046|NCT02246673|O9|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
31047|NCT02246673|O8|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
31048|NCT02246673|O7|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
31049|NCT02246673|O6|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
31050|NCT02246673|O5|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
31051|NCT02246673|O4|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
31052|NCT02246673|O3|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
31053|NCT02246673|O2|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
31054|NCT02246673|O1|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
31055|NCT02246673|O9|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
31056|NCT02246673|O8|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
31057|NCT02246673|O7|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
31058|NCT02246673|O6|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
31059|NCT02246673|O5|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
31060|NCT02246673|O4|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
31061|NCT02246673|O3|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
31062|NCT02246673|O2|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
31063|NCT02246673|O1|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
31064|NCT02246673|O9|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
44534|NCT02130999|O2|Outcome|Tasimelteon 2mg IV|
31068|NCT02246673|O5|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
31069|NCT02246673|O4|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
31070|NCT02246673|O3|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
31073|NCT02246673|O9|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Overall (Cohort 5)
31074|NCT02246673|O8|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Overall (Cohort 4)
31075|NCT02246673|O7|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Overall (Cohort 4)
31076|NCT02246673|O6|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Overall (Cohort 3)
31077|NCT02246673|O5|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Overall (Cohort 3)
31078|NCT02246673|O4|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Overall (Cohort 2)
31079|NCT02246673|O3|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Overall (Cohorts 2 and 5)
31080|NCT02246673|O2|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Overall (Cohort 1)
31081|NCT02246673|O1|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Overall (Cohorts 1 and 5)
31082|NCT02246673|O11|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
31083|NCT02246673|O10|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
31084|NCT02246673|O9|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 4)
31085|NCT02246673|O8|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
31086|NCT02246673|O7|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 3)
31087|NCT02246673|O6|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
31088|NCT02246673|O5|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 2 and 5)
31089|NCT02246673|O4|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
31090|NCT02246673|O3|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 and 5)
31091|NCT02246673|O2|Outcome|Febuxostat 80 mg|Days 14/21 Overall (Cohorts 1 through 5)
31092|NCT02246673|O1|Outcome|Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 through 5)
31093|NCT02246673|O11|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
31094|NCT02246673|O10|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
31095|NCT02246673|O9|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 4)
31096|NCT02246673|O8|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
31097|NCT02246673|O7|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 3)
31098|NCT02246673|O6|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
31099|NCT02246673|O5|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 2 and 5)
31100|NCT02246673|O4|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
31101|NCT02246673|O3|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 and 5)
31102|NCT02246673|O2|Outcome|Febuxostat 80 mg|Days 14/21 Overall (Cohorts 1 through 5)
31103|NCT02246673|O1|Outcome|Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 through 5)
31104|NCT02246673|O11|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
31105|NCT02246673|O10|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
31106|NCT02246673|O9|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 4)
31107|NCT02246673|O8|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
31108|NCT02246673|O7|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 3)
31109|NCT02246673|O6|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
31110|NCT02246673|O5|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 2 and 5)
31111|NCT02246673|O4|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
31112|NCT02246673|O3|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 and 5)
31113|NCT02246673|O2|Outcome|Febuxostat 80 mg|Days 14/21 Overall (Cohorts 1 through 5)
31114|NCT02246673|O1|Outcome|Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 through 5)
31115|NCT02246673|O11|Outcome|RDEA3170 20 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 5)
31116|NCT02246673|O10|Outcome|RDEA3170 2.5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 4)
31117|NCT02246673|O9|Outcome|RDEA3170 2.5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 4)
31118|NCT02246673|O8|Outcome|RDEA3170 5 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 3)
31119|NCT02246673|O7|Outcome|RDEA3170 5 mg + Febuxostat 40 mg|Days 14/21 Overall (Cohort 3)
31120|NCT02246673|O6|Outcome|RDEA3170 15 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 2)
31121|NCT02246673|O5|Outcome|RDEA3170 15 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 2 and 5)
31122|NCT02246673|O4|Outcome|RDEA3170 10 mg + Febuxostat 80 mg|Days 14/21 Overall (Cohort 1)
31123|NCT02246673|O3|Outcome|RDEA3170 10 mg + Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 and 5)
31124|NCT02246673|O2|Outcome|Febuxostat 80 mg|Days 7/28 Overall (Cohorts 1 through 5)
31125|NCT02246673|O1|Outcome|Febuxostat 40 mg|Days 7/14/21/28 Overall (Cohorts 1 through 5)
31126|NCT02246673|E3|Reported Event|Overall RDEA3170 + Febuxostat Combination|
31127|NCT02246673|E2|Reported Event|Febuxostat 80 mg|
31128|NCT02246673|E1|Reported Event|Febuxostat 40 mg|
31129|NCT02246582|B1|Baseline|All Subjects|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.
Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile App
640G Insulin Pump"
31245|NCT02244580|O2|Outcome|OS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels|Determination of OS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels
31130|NCT02246582|P2|Participant Flow|Group B (FST 14 Hrs After Sensor Insertion)|"Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile App
640G Insulin Pump"
31247|NCT02244580|O1|Outcome|Patients With MKI67 mRNA Determination|Patients with low MKI67 mRNA
31644|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
31131|NCT02246582|P1|Participant Flow|Group A (FST 30 Mins After Sensor Insertion)|"Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile App
640G Insulin Pump"
31132|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.
Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile App
640G Insulin Pump"
31133|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.
Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile App
640G Insulin Pump"
31134|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.
Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile App
640G Insulin Pump"
31135|NCT02246582|E1|Reported Event|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.
Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile App
640G Insulin Pump"
31136|NCT02246166|B3|Baseline|Total|Total of all reporting groups
31137|NCT02246166|B2|Baseline|Placebo|Matching placebo tablet
31138|NCT02246166|B1|Baseline|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31139|NCT02246166|P2|Participant Flow|Placebo|Matching placebo tablet
31140|NCT02246166|P1|Participant Flow|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31141|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31142|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31143|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31144|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31145|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31146|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31147|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31148|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31149|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31150|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31151|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31152|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31153|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31154|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31155|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31156|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31157|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31158|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31159|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31160|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31161|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31162|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31163|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31164|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31165|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31166|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31167|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31168|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31169|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
31170|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31171|NCT02246166|E2|Reported Event|Placebo|Matching placebo tablet
31172|NCT02246166|E1|Reported Event|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
31173|NCT02246114|B3|Baseline|Total|Total of all reporting groups
31174|NCT02246114|B2|Baseline|Arm B|CO monitor
31175|NCT02246114|B1|Baseline|Arm A|no CO monitor
31176|NCT02246114|P2|Participant Flow|Arm B|CO monitor
31177|NCT02246114|P1|Participant Flow|Arm A|no CO monitor
31178|NCT02246114|O2|Outcome|Arm B|CO monitor
31179|NCT02246114|O1|Outcome|Arm A|no CO monitor
31180|NCT02246114|E2|Reported Event|Arm B (CO Monitor)|CO monitor
31181|NCT02246114|E1|Reported Event|Arm A (no CO Monitor)|no CO monitor
31182|NCT02246062|B5|Baseline|Total|Total of all reporting groups
31183|NCT02246062|B4|Baseline|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone: the child received smartphone application immediately before entering the operating room"
31184|NCT02246062|B3|Baseline|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
smartphone: the child received smartphone application immediately before entering the operating room"
31185|NCT02246062|B2|Baseline|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
31186|NCT02246062|B1|Baseline|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
31187|NCT02246062|P4|Participant Flow|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone: the child received smartphone application immediately before entering the operating room"
31188|NCT02246062|P3|Participant Flow|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
smartphone: the child received smartphone application immediately before entering the operating room"
31189|NCT02246062|P2|Participant Flow|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
31190|NCT02246062|P1|Participant Flow|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
31191|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone: the child received smartphone application immediately before entering the operating room"
31192|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
smartphone: the child received smartphone application immediately before entering the operating room"
31193|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
31194|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
31195|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone: the child received smartphone application immediately before entering the operating room"
31246|NCT02244580|O1|Outcome|DDFS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels|Determination of DDFS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels
31196|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
smartphone: the child received smartphone application immediately before entering the operating room"
31197|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
31198|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
31199|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone: the child received smartphone application immediately before entering the operating room"
31200|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
smartphone: the child received smartphone application immediately before entering the operating room"
31201|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
31202|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
31203|NCT02246062|E4|Reported Event|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone: the child received smartphone application immediately before entering the operating room"
31204|NCT02246062|E3|Reported Event|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
smartphone: the child received smartphone application immediately before entering the operating room"
31205|NCT02246062|E2|Reported Event|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
31206|NCT02246062|E1|Reported Event|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
31207|NCT02245360|B3|Baseline|Total|Total of all reporting groups
31208|NCT02245360|B2|Baseline|Placebo|"Placebo
placebo: placebo tablet given once daily over 60 days"
31209|NCT02245360|B1|Baseline|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
31210|NCT02245360|P2|Participant Flow|Placebo|"Placebo
placebo: placebo tablet given once daily over 60 days"
31211|NCT02245360|P1|Participant Flow|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
31212|NCT02245360|O2|Outcome|Placebo|"Placebo
placebo: placebo tablet given once daily over 60 days"
31213|NCT02245360|O1|Outcome|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
31214|NCT02245360|O2|Outcome|Placebo|"Placebo
placebo: placebo tablet given once daily over 60 days"
31215|NCT02245360|O1|Outcome|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
31216|NCT02245360|E2|Reported Event|Placebo|"Placebo
placebo: placebo tablet given once daily over 60 days"
31217|NCT02245360|E1|Reported Event|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
31218|NCT02244840|B1|Baseline|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject
Electronic bidet: commercial electronic bidet
Sitz bath: Conventional sitz bath"
31219|NCT02244840|P1|Participant Flow|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject
Electronic bidet: commercial electronic bidet
Sitz bath: Conventional sitz bath"
31220|NCT02244840|O1|Outcome|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject
Electronic bidet: commercial electronic bidet
Sitz bath: Conventional sitz bath"
31221|NCT02244840|E1|Reported Event|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject
Electronic bidet: commercial electronic bidet
Sitz bath: Conventional sitz bath"
31222|NCT02244619|B3|Baseline|Total|Total of all reporting groups
31223|NCT02244619|B2|Baseline|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
31248|NCT02244580|O2|Outcome|Combined Subtype|Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation
31249|NCT02244580|O1|Outcome|Luminal A|Patients subtyped as Luminal A with DDFS determined 5 years after randomisation
31224|NCT02244619|B1|Baseline|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
31225|NCT02244619|P2|Participant Flow|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
31226|NCT02244619|P1|Participant Flow|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
31227|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
31228|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
31229|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
31230|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
31231|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
31232|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
31233|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
31234|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
31235|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
31236|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
31237|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
31238|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
31239|NCT02244619|O2|Outcome|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
31240|NCT02244619|O1|Outcome|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
31241|NCT02244619|E2|Reported Event|IV Acetaminophen|"Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity."
31242|NCT02244619|E1|Reported Event|Oral Acetaminophen|"Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity."
31243|NCT02244580|B1|Baseline|FinHer Patients|"Of all patients, FFPE tumour block was processed with the RNXtract RNA extraction kit (BioNTech Diagnostics GmbH, Mainz) using a magnetic particle-based assay (Supplemental file 1A).
RT-qPCR was done with the MammaTyper kit (BioNTech Diagnostics GmbH, Mainz) for ESR1, PGR, ERBB2 and MKI67."
31244|NCT02244580|P1|Participant Flow|MammaTyper™|"MammaTyper™ kit will be used to assess tumor material of patients enrolled into the FinHer trial.
MammaTyper™: MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67."
31250|NCT02244580|E1|Reported Event||Since only tumor material was used, adverse events were not documented within the MammaTyper Study
31251|NCT02243943|B3|Baseline|Total|Total of all reporting groups
31252|NCT02243943|B2|Baseline|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg
Neostigmine"
31253|NCT02243943|B1|Baseline|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
Sugammadex"
31254|NCT02243943|P2|Participant Flow|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg
Neostigmine"
31255|NCT02243943|P1|Participant Flow|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
Sugammadex"
31256|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg
Neostigmine"
31257|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
Sugammadex"
31258|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg
Neostigmine"
31259|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
Sugammadex"
31260|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg
Neostigmine"
31261|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
Sugammadex"
31262|NCT02243943|E2|Reported Event|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg
Neostigmine"
31263|NCT02243943|E1|Reported Event|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
Sugammadex"
31264|NCT02243280|B12|Baseline|Total|Total of all reporting groups
31265|NCT02243280|B11|Baseline|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
31266|NCT02243280|B10|Baseline|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
31267|NCT02243280|B9|Baseline|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
31268|NCT02243280|B8|Baseline|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31269|NCT02243280|B7|Baseline|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31270|NCT02243280|B6|Baseline|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
31271|NCT02243280|B5|Baseline|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31272|NCT02243280|B4|Baseline|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31273|NCT02243280|B3|Baseline|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31274|NCT02243280|B2|Baseline|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
31275|NCT02243280|B1|Baseline|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
31276|NCT02243280|P11|Participant Flow|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
31277|NCT02243280|P10|Participant Flow|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
31278|NCT02243280|P9|Participant Flow|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
31279|NCT02243280|P8|Participant Flow|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31280|NCT02243280|P7|Participant Flow|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31281|NCT02243280|P6|Participant Flow|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
31282|NCT02243280|P5|Participant Flow|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31283|NCT02243280|P4|Participant Flow|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31284|NCT02243280|P3|Participant Flow|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31285|NCT02243280|P2|Participant Flow|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
31286|NCT02243280|P1|Participant Flow|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
31287|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
31288|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
31289|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
31290|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31291|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31292|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
31293|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31294|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31295|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31296|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
31297|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
31298|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
31299|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
31300|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
31301|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31302|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31303|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
31304|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31305|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31306|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31307|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
31308|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
31309|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
31310|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
31311|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
31312|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31313|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31314|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
31315|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31316|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31317|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31318|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
31319|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
31320|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
31321|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
31322|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
31323|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31324|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31640|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
31325|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
31326|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
31327|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31328|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
31329|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
31330|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
31331|NCT02243280|E5|Reported Event|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis
31332|NCT02243280|E4|Reported Event|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6- infected participants without cirrhosis
31333|NCT02243280|E3|Reported Event|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis
31334|NCT02243280|E2|Reported Event|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
31335|NCT02243280|E1|Reported Event|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
31336|NCT02243202|B5|Baseline|Total|Total of all reporting groups
31337|NCT02243202|B4|Baseline|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
31338|NCT02243202|B3|Baseline|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
31339|NCT02243202|B2|Baseline|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
31340|NCT02243202|B1|Baseline|Placebo|Participants received placebo tablets orally for 26 weeks.
31341|NCT02243202|P4|Participant Flow|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
31342|NCT02243202|P3|Participant Flow|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
31343|NCT02243202|P2|Participant Flow|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
31344|NCT02243202|P1|Participant Flow|Placebo|Participants received placebo tablets orally for 26 weeks.
31345|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
31346|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
31347|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
31348|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
31349|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
31350|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
31351|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
31352|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
31353|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
31354|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
31355|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
31356|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
31357|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
31358|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
31359|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
31360|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
31361|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
31362|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
31363|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
31364|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
31365|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
31366|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
31367|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
31368|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
31369|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
31370|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
31371|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
31372|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
31373|NCT02243202|E4|Reported Event|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
31374|NCT02243202|E3|Reported Event|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
31375|NCT02243202|E2|Reported Event|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
31376|NCT02243202|E1|Reported Event|Placebo|Participants received placebo tablets orally for 26 weeks.
31377|NCT02243176|B3|Baseline|Total|Total of all reporting groups
31378|NCT02243176|B2|Baseline|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31379|NCT02243176|B1|Baseline|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31380|NCT02243176|P2|Participant Flow|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31381|NCT02243176|P1|Participant Flow|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31382|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31383|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31384|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31385|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31386|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31387|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31388|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31389|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31390|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31391|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31392|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31393|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31517|NCT02242305|B2|Baseline|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
31394|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31395|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31396|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31397|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31398|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31399|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31400|NCT02243176|E2|Reported Event|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
31401|NCT02243176|E1|Reported Event|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
31402|NCT02243046|B4|Baseline|Total|Total of all reporting groups
31403|NCT02243046|B3|Baseline|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31404|NCT02243046|B2|Baseline|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31405|NCT02243046|B1|Baseline|Control Toothpaste|"1450 ppm Fluoride toothpaste
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31406|NCT02243046|P3|Participant Flow|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31407|NCT02243046|P2|Participant Flow|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31408|NCT02243046|P1|Participant Flow|Control Toothpaste|"1450 ppm Fluoride toothpaste
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31409|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31410|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31411|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31412|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31413|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31634|NCT02240368|P2|Participant Flow|Group 2|Children age between 13 months and 36 months
31414|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31645|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
31646|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
31415|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31416|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31417|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31418|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31419|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31420|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31421|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31422|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31423|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31424|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste
Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31425|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31426|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31427|NCT02243046|E3|Reported Event|Active Comparator|1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
31428|NCT02243046|E2|Reported Event|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base
Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31429|NCT02243046|E1|Reported Event|Control Toothpaste|"1450 ppm Fluoride toothpaste
Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
31430|NCT02243007|B3|Baseline|Total|Total of all reporting groups
31431|NCT02243007|B2|Baseline|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31432|NCT02243007|B1|Baseline|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31635|NCT02240368|P1|Participant Flow|Group 1|Children age between 1 month to 12 months
31518|NCT02242305|B1|Baseline|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
31647|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
31433|NCT02243007|P2|Participant Flow|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31434|NCT02243007|P1|Participant Flow|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31435|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31436|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31437|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31438|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31439|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31440|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31441|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31442|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31470|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31514|NCT02242630|E2|Reported Event|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31443|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31444|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31445|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31446|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31447|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31448|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31449|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31450|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31451|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31452|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31471|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31515|NCT02242630|E1|Reported Event|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31453|NCT02243007|E2|Reported Event|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Gemcitabine/nab-Paclitaxel
Radiation therapy
Capecitabine"
31454|NCT02243007|E1|Reported Event|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
FOLFIRINOX
Radiation therapy
Capecitabine"
31455|NCT02242994|B1|Baseline|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.
Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
Experimental App: Participant receives experimental app to test speed and error rate of communication."
31456|NCT02242994|P1|Participant Flow|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.
Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
Experimental App: Participant receives experimental app to test speed and error rate of communication."
31457|NCT02242994|O1|Outcome|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.
Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
Experimental App: Participant receives experimental app to test speed and error rate of communication."
31458|NCT02242994|O1|Outcome|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.
Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
Experimental App: Participant receives experimental app to test speed and error rate of communication."
31459|NCT02242994|E1|Reported Event|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.
Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
Experimental App: Participant receives experimental app to test speed and error rate of communication."
31460|NCT02242643|B3|Baseline|Total|Total of all reporting groups
31461|NCT02242643|B2|Baseline|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31462|NCT02242643|B1|Baseline|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31463|NCT02242643|P2|Participant Flow|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31464|NCT02242643|P1|Participant Flow|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31465|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31466|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31467|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31468|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31469|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31472|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31473|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31474|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31475|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31476|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31477|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
31478|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
31479|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31480|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31481|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
31482|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
31483|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
31484|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
31485|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31486|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31487|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31488|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31489|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31516|NCT02242305|B3|Baseline|Total|Total of all reporting groups
31490|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31491|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31492|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31493|NCT02242643|E2|Reported Event|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31494|NCT02242643|E1|Reported Event|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
31495|NCT02242630|B5|Baseline|Total|Total of all reporting groups
31496|NCT02242630|B4|Baseline|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone"
31497|NCT02242630|B3|Baseline|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31498|NCT02242630|B2|Baseline|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31499|NCT02242630|B1|Baseline|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31500|NCT02242630|P4|Participant Flow|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone"
31501|NCT02242630|P3|Participant Flow|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31502|NCT02242630|P2|Participant Flow|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31503|NCT02242630|P1|Participant Flow|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31504|NCT02242630|O4|Outcome|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone"
31505|NCT02242630|O3|Outcome|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31506|NCT02242630|O2|Outcome|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31507|NCT02242630|O1|Outcome|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31508|NCT02242630|O4|Outcome|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone"
31509|NCT02242630|O3|Outcome|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31510|NCT02242630|O2|Outcome|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31511|NCT02242630|O1|Outcome|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31512|NCT02242630|E4|Reported Event|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 20 mg: Compared with methylprednisolone"
31513|NCT02242630|E3|Reported Event|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone
Triamcinolone, 40 mg: Compared with methylprednisolone"
31636|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
31519|NCT02242305|P2|Participant Flow|Hyoscine Butylbromide - Capsule (Cap.)|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
31520|NCT02242305|P1|Participant Flow|Hyoscine Butylbromide - Tablet (Tab.)|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
31521|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
31522|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
31523|NCT02242305|O2|Outcome|Hyoscine Butylbromide – Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
31524|NCT02242305|O1|Outcome|Hyoscine Butylbromide – Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
31525|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
31526|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
31527|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
31528|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
31529|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
31530|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
31531|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
31532|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
31533|NCT02242305|O2|Outcome|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
31534|NCT02242305|O1|Outcome|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
31535|NCT02242305|E2|Reported Event|Hyoscine Butylbromide - Capsule|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
31536|NCT02242305|E1|Reported Event|Hyoscine Butylbromide - Tablet|The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
31537|NCT02242019|B1|Baseline|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
31538|NCT02242019|P1|Participant Flow|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
31539|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
31540|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
31541|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
31542|NCT02242019|E1|Reported Event|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
31543|NCT02241889|B1|Baseline|All Study Participants|All study participants underwent three 21 hour study visits using either standard of care insulin pump therapy, closed loop control, or closed loop control with adjustments to insulin and glucagon after exercise announcement. Treatment order was randomized.
31544|NCT02241889|P6|Participant Flow|APX, APN, SAP (21 Hours)|The randomization order for subjects in this arm was closed loop with exercise announcement (APX), closed loop (APN) and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
31545|NCT02241889|P5|Participant Flow|APX, SAP, APN (21 Hours)|The randomization order for subjects in this arm was closed loop with exercise announcement (APX), open loop (Sensor Augmented Pump SAP) and closed loop (APN). Each visit was 21 hours.
31546|NCT02241889|P4|Participant Flow|APN, APX, SAP (21 Hours)|The randomization order for subjects in this arm was closed loop (APN), closed loop with exercise announcement (APX), and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
31547|NCT02241889|P3|Participant Flow|APN, SAP and APX (21 Hours)|The randomization order for subjects in this arm was closed loop (APN), open loop (Sensor Augmented Pump SAP), and closed loop with exercise announcement (APX). Each visit was 21 hours.
31548|NCT02241889|P2|Participant Flow|SAP, APX, APN (21 Hours)|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop with exercise announcement (APX), and closed loop (APN). Each visit was 21 hours.
31637|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
31638|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
31549|NCT02241889|P1|Participant Flow|SAP, APN, APX (21 Hours)|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop (APN) and closed loop with exercise announcement (APX). Each visit was 21 hours.
31550|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31551|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31552|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
31553|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31554|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31555|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
31556|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31557|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31558|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
31559|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31560|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31561|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
31562|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31563|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31639|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
31564|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
31565|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31566|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31567|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
31568|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31569|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31570|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
31571|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31572|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31573|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
31574|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31575|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31576|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
31577|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31578|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
44535|NCT02130999|O1|Outcome|Tasimelteon 20mg Oral|
31579|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
31580|NCT02241889|E3|Reported Event|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31581|NCT02241889|E2|Reported Event|Closed-loop Without Adjustment|"Subjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
31582|NCT02241889|E1|Reported Event|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
31583|NCT02241785|B1|Baseline|Natalizumab|natalizumab 300 mg IV every 4 weeks
31584|NCT02241785|P1|Participant Flow|Natalizumab|natalizumab 300 mg intravenously (IV) every 4 weeks
31585|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
31586|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
31587|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
31588|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
31589|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
31590|NCT02241785|E1|Reported Event|Natalizumab|natalizumab 300 mg IV every 4 weeks
31591|NCT02241486|B1|Baseline|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
31592|NCT02241486|P1|Participant Flow|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
31593|NCT02241486|O1|Outcome|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
31594|NCT02241486|E1|Reported Event|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
31595|NCT02240628|B3|Baseline|Total|Total of all reporting groups
31596|NCT02240628|B2|Baseline|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.
Saline: Patients in arm 2 will receive Saline with the Propofol."
31597|NCT02240628|B1|Baseline|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.
Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
31598|NCT02240628|P2|Participant Flow|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.
Saline: Patients in arm 2 will receive Saline with the Propofol."
31599|NCT02240628|P1|Participant Flow|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.
Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
31600|NCT02240628|O2|Outcome|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.
Saline: Patients in arm 2 will receive Saline with the Propofol."
31601|NCT02240628|O1|Outcome|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.
Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
31602|NCT02240628|O2|Outcome|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.
Saline: Patients in arm 2 will receive Saline with the Propofol."
44536|NCT02130999|O2|Outcome|IV (2 mg)|
31641|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
31642|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
31643|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
31603|NCT02240628|O1|Outcome|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.
Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
31604|NCT02240628|E2|Reported Event|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.
Saline: Patients in arm 2 will receive Saline with the Propofol."
31605|NCT02240628|E1|Reported Event|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.
Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.
Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
31606|NCT02240589|B3|Baseline|Total|Total of all reporting groups
31607|NCT02240589|B2|Baseline|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
31608|NCT02240589|B1|Baseline|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
31609|NCT02240589|P2|Participant Flow|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
31610|NCT02240589|P1|Participant Flow|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
31611|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
31612|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
31613|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
31614|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
31615|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
31616|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
31617|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
31618|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
31619|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
31620|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
31621|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
31622|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
31623|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
31624|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
31625|NCT02240589|O2|Outcome|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
31626|NCT02240589|O1|Outcome|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
31627|NCT02240589|E2|Reported Event|Placebo|"24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.
Placebo: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo."
31628|NCT02240589|E1|Reported Event|Memantine|"24 weeks of memantine with accelerated titration, beginning within 48 hours of injury.
Memantine: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine."
31629|NCT02240368|B4|Baseline|Total|Total of all reporting groups
31630|NCT02240368|B3|Baseline|Group 3|Children age between 37 months to 144 months
31631|NCT02240368|B2|Baseline|Group 2|Children age between 13 months and 36 months
31632|NCT02240368|B1|Baseline|Group 1|Children age between 1 month to 12 months
31633|NCT02240368|P3|Participant Flow|Group 3|Children age between 37 months to 144 months
31648|NCT02240368|E3|Reported Event|Group 3|Children age between 37 months to 144 months
31649|NCT02240368|E2|Reported Event|Group 2|Children age between 13 months and 36 months
31650|NCT02240368|E1|Reported Event|Group 1|Children age between 1 month to 12 months
31651|NCT02240329|B1|Baseline|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.
Respiratory measures: We will collect measures of cough airflow and breathing strength.
Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
31652|NCT02240329|P1|Participant Flow|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.
Respiratory measures: We will collect measures of cough airflow and breathing strength.
Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
31653|NCT02240329|O1|Outcome|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.
Respiratory measures: We will collect measures of cough airflow and breathing strength.
Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
31654|NCT02240329|O1|Outcome|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.
Respiratory measures: We will collect measures of cough airflow and breathing strength.
Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
31655|NCT02240329|E1|Reported Event|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.
Respiratory measures: We will collect measures of cough airflow and breathing strength.
Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
31656|NCT02239978|B3|Baseline|Total|Total of all reporting groups
31657|NCT02239978|B2|Baseline|Control|"Age-matched healthy adults
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31658|NCT02239978|B1|Baseline|Parkinsons Disease|"Individuals with Parkinsons disease
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31659|NCT02239978|P2|Participant Flow|Control|"Age-matched healthy adults
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31660|NCT02239978|P1|Participant Flow|Parkinsons Disease|"Individuals with Parkinsons disease
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31661|NCT02239978|O2|Outcome|Parkinson's Disease Off Medication|"These are the same participants as in the Parkinson's disease group, assessed Off their levodopa medication"
31662|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31663|NCT02239978|O3|Outcome|Parkinson's Disease Off Medication|"These are the same individuals in the Parkinson's disease group, but Off their levodopa"
31664|NCT02239978|O2|Outcome|Control|"Age-matched healthy adults
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31841|NCT02237118|O2|Outcome|UrgoTul|"Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul"
31665|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31666|NCT02239978|O3|Outcome|Parkinson's Disease Off Medication|"These are the same individuals in the Parkinson's disease group, but Off their levodopa"
31988|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
31667|NCT02239978|O2|Outcome|Control|"Age-matched healthy adults
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31668|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31669|NCT02239978|O3|Outcome|Parkinson's Disease Off Medication|"These are the same individuals in the Parkinson's disease group, but Off their levodopa"
31670|NCT02239978|O2|Outcome|Control|"Age-matched healthy adults
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31671|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31672|NCT02239978|E2|Reported Event|Control|"Age-matched healthy adults
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31673|NCT02239978|E1|Reported Event|Parkinsons Disease|"Individuals with Parkinsons disease
Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
31674|NCT02239926|B3|Baseline|Total|Total of all reporting groups
31675|NCT02239926|B2|Baseline|Placebo|Placebo
31676|NCT02239926|B1|Baseline|Ranolazine|tablet, 1000 mg twice daily for four weeks
31677|NCT02239926|P2|Participant Flow|Placebo|Placebo
31678|NCT02239926|P1|Participant Flow|Ranolazine|tablet, 1000 mg twice daily for four weeks
31679|NCT02239926|O2|Outcome|Placebo|Placebo
31680|NCT02239926|O1|Outcome|Ranolazine|tablet, 1000 mg twice daily for four weeks
31681|NCT02239926|O2|Outcome|Placebo|Placebo
31682|NCT02239926|O1|Outcome|Ranolazine|tablet, 1000 mg twice daily for four weeks
31683|NCT02239926|E2|Reported Event|Placebo|Placebo
31684|NCT02239926|E1|Reported Event|Ranolazine|tablet, 1000 mg twice daily for four weeks
31685|NCT02239744|B3|Baseline|Total|Total of all reporting groups
31686|NCT02239744|B2|Baseline|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
31687|NCT02239744|B1|Baseline|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
31688|NCT02239744|P2|Participant Flow|True Purifiers First, Then Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used true air purifiers.In the second period, this group used sham air purifiers.
31689|NCT02239744|P1|Participant Flow|Sham Purifiers First, Then True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used sham air purifiers with the only difference being removal of the filter gauze. In the second period, this group used true air purifiers.
31690|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
31691|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
31692|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
31693|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
31694|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
31695|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
31696|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
31697|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
31698|NCT02239744|E2|Reported Event|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
31699|NCT02239744|E1|Reported Event|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
31700|NCT02239692|B3|Baseline|Total|Total of all reporting groups
31701|NCT02239692|B2|Baseline|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31702|NCT02239692|B1|Baseline|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31842|NCT02237118|O1|Outcome|Mepitel One|"Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul"
31703|NCT02239692|P2|Participant Flow|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31735|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31704|NCT02239692|P1|Participant Flow|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31705|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31706|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31707|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31708|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31709|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31710|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31711|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31712|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31713|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31714|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31715|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31716|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31717|NCT02239692|E2|Reported Event|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31718|NCT02239692|E1|Reported Event|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
31719|NCT02239289|B1|Baseline|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31720|NCT02239289|P1|Participant Flow|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31721|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31722|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31723|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31724|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31725|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31726|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31727|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31728|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31729|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31730|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31731|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31732|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31733|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31843|NCT02237118|E2|Reported Event|UrgoTul|"Pain on removal by VAS
Mepitel One
UrgoTul"
31734|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
32896|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
31736|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31737|NCT02239289|E1|Reported Event|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training
Biofeedback: Idem as described in the arm section (above)"
31738|NCT02238782|B1|Baseline|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
31739|NCT02238782|P1|Participant Flow|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
31740|NCT02238782|O1|Outcome|Selumetinib|Selumetinib 75 mg oral followed by IV carbon 14 selumetinib (80 micrograms) administered 1 hour 15 minutes after the oral dose.
31741|NCT02238782|E1|Reported Event|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
31742|NCT02238379|B3|Baseline|Total|Total of all reporting groups
31743|NCT02238379|B2|Baseline|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31744|NCT02238379|B1|Baseline|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31745|NCT02238379|P2|Participant Flow|Placebo First, Then Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31746|NCT02238379|P1|Participant Flow|Oxytocin First, Then Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31747|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31748|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31749|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31750|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31751|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31752|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31753|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31754|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31755|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31756|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31757|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31758|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31759|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31760|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31761|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31762|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31763|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31764|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
32057|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
31765|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31766|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31767|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31768|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31769|NCT02238379|E2|Reported Event|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
31770|NCT02238379|E1|Reported Event|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
31771|NCT02238080|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31772|NCT02238080|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and chronic kidney disease (CKD) who were on dialysis therapy, and who initiated erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta (Mircera) or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31773|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31774|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31775|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31776|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31777|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31778|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31779|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31780|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31781|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31782|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31783|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31784|NCT02238080|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
31844|NCT02237118|E1|Reported Event|Mepitel One|"Pain on dressing removal, by VAS
Mepitel One
UrgoTul"
31912|NCT02235831|P3|Participant Flow|Seq 3|DACP MF (Low Add) lenses worn first, followed by DACP MF lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
31785|NCT02238067|B1|Baseline|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31786|NCT02238067|P1|Participant Flow|Chronic Renal Anemia Participants|Participants with Chronic Kidney Disease (CKD) who were not on dialysis and treated with Erythropoiesis-Stimulating Agents (ESA) according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31787|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31788|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31789|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31790|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31791|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31792|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31793|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31794|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31795|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31796|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31797|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31798|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31799|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31800|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31801|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31802|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31803|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31804|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31805|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31908|NCT02235831|B1|Baseline|Overall|DACP MF, DACP MF (Low Add), and DACP (monovision) lenses worn in 6 different sequences as randomized in a crossover assignment.
31806|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31807|NCT02238067|E1|Reported Event|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
31808|NCT02238028|B1|Baseline|All Study Participants|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days including a 2-hour walking along the streets on the 2nd day along a fixed route. After a 2-week rest period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days including the 2-hour walking along the streets on the 2nd day along the same fixed route. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
31809|NCT02238028|P2|Participant Flow|Not Wearing Respirator First,Then Wearing Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
31810|NCT02238028|P1|Participant Flow|Wearing Respirator First,Then Not Wearing Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
31811|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
31812|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
31813|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
31814|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
31815|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
31816|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
31817|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
31909|NCT02235831|P6|Participant Flow|Seq 6|DACP (monovision) lenses first, followed by DACP MF (Low Add) lenses next, and DACP MF lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
31818|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
31819|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
31820|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
31821|NCT02238028|O1|Outcome|All Study Participants|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
31822|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
31823|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
31824|NCT02238028|O2|Outcome|Not Wear Respirator|The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
31825|NCT02238028|O1|Outcome|Wear Respirator|"The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
31826|NCT02238028|E2|Reported Event|Not Wear Respirator|The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
31827|NCT02238028|E1|Reported Event|Wear Respirator|"The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
31828|NCT02237118|B3|Baseline|Total|Total of all reporting groups
31829|NCT02237118|B2|Baseline|UrgoTul|"Pain on dressing removal, by VAS
Mepitel One
UrgoTul"
31830|NCT02237118|B1|Baseline|Mepitel One|"Pain on dressing removal, by VAS
Mepitel One
UrgoTul"
31831|NCT02237118|P2|Participant Flow|UrgoTul|"Pain on removal by VAS
UrgoTul"
31832|NCT02237118|P1|Participant Flow|Mepitel One|"Pain on dressing removal, by VAS
Mepitel One"
31833|NCT02237118|O2|Outcome|UrgoTul|Condition of the surrounding skin
31834|NCT02237118|O1|Outcome|Mepitel One|Condition of the surrounding skin
31835|NCT02237118|O2|Outcome|Safety UrgoTul|Adverse Event and Adverse Device Effect
31836|NCT02237118|O1|Outcome|Safety Mepitel One|Adverse Event and Adverse Device Effect
31837|NCT02237118|O2|Outcome|Condition of the Wound, UrgoTul|Condition of the wound, UrgoTul, assessed by the investigator
31838|NCT02237118|O1|Outcome|Condition of the Wound Mepitel One|Condition of the wound assesed by the investigator
31839|NCT02237118|O2|Outcome|UrgoTul|Complete healing was reported for 27 subjects ( 49,1%) in theUrgoTul group.
31840|NCT02237118|O1|Outcome|Mepitel One|Complete healing was reported for 39 subjects ( 68,4%) in the Mepitel One group.
31845|NCT02237092|B1|Baseline|Measurement of IAP|Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.The data obtained are in inches of water column were translated in millimeters of mercury.
31846|NCT02237092|P1|Participant Flow|Measurement of IAP|"The data obtained are in inches of water column were translated in millimeters of mercury.
Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration."
31847|NCT02237092|O2|Outcome|Level of IAP = > 16 mm Hg|number of pregnant women with Level of IAP = > 16 mm Hg
31848|NCT02237092|O1|Outcome|Level of IAP < 16 mm Hg|number of pregnant women with Level of IAP < 16 mm Hg
31849|NCT02237092|O2|Outcome|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
31850|NCT02237092|O1|Outcome|Level of Sensory Block => Th4 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
31851|NCT02237092|O2|Outcome|Obesity|BMI = > 30.00
31852|NCT02237092|O1|Outcome|No Obesity|BMI < = 29.99
31853|NCT02237092|O2|Outcome|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
31854|NCT02237092|O1|Outcome|Level of Sensory Block => Th4 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
31855|NCT02237092|O4|Outcome|Grade III|(21 - 25.99 mm Hg)
31856|NCT02237092|O3|Outcome|Grade II|(16 - 20.99 mm Hg)
31857|NCT02237092|O2|Outcome|Grade I|(12 - 15.99 mm Hg)
31858|NCT02237092|O1|Outcome|Physiological Norm|(≤11,99 mm Hg)
31859|NCT02237092|O1|Outcome|Intra-abdominal Pressure (IAP) in Pregnant Women|Average IAP in pregnant women
31860|NCT02237092|E2|Reported Event|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
31861|NCT02237092|E1|Reported Event|Level of Sensory Block => Th4 (Spinal Anesthesia)|Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
31862|NCT02236767|B1|Baseline|TMS Therapy|"NeuroStar TMS Therapy System
Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
31863|NCT02236767|P1|Participant Flow|TMS Therapy|"NeuroStar TMS Therapy System
Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
31864|NCT02236767|O1|Outcome|rTMS Treatment|"NeuroStar TMS Therapy System
Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
31865|NCT02236767|E1|Reported Event|TMS Therapy|"NeuroStar TMS Therapy System
Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
31866|NCT02236611|B3|Baseline|Total|Total of all reporting groups
31867|NCT02236611|B2|Baseline|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
31868|NCT02236611|B1|Baseline|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
31869|NCT02236611|P2|Participant Flow|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
31870|NCT02236611|P1|Participant Flow|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
31871|NCT02236611|O2|Outcome|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
31872|NCT02236611|O1|Outcome|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
31873|NCT02236611|E2|Reported Event|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
31874|NCT02236611|E1|Reported Event|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
31875|NCT02236598|B3|Baseline|Total|Total of all reporting groups
31986|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
31876|NCT02236598|B2|Baseline|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo"
31877|NCT02236598|B1|Baseline|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement"
31878|NCT02236598|P2|Participant Flow|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo"
31879|NCT02236598|P1|Participant Flow|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement"
31880|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo"
31881|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement"
31882|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo"
31883|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement"
31884|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo"
31885|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement"
31886|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo"
31887|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement"
31888|NCT02236598|E2|Reported Event|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo"
31889|NCT02236598|E1|Reported Event|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement"
31890|NCT02236546|B1|Baseline|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Molecular assays on biopsied tissue: Correlative studies
positron emission tomography: Undergo FDG-PET/CT
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
31891|NCT02236546|P1|Participant Flow|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Molecular assays on biopsied tissue: Correlative studies
positron emission tomography: Undergo FDG-PET/CT
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
31910|NCT02235831|P5|Participant Flow|Seq 5|DACP (monovision) lenses first, followed by DACP MF lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
31911|NCT02235831|P4|Participant Flow|Seq 4|DACP MF (Low Add) lenses worn first, followed by DACP (monovision) lenses next, and DACP MF last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
32054|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
31892|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Molecular assays on biopsied tissue: Correlative studies
positron emission tomography: Undergo FDG-PET/CT
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
31893|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Molecular assays on biopsied tissue: Correlative studies
positron emission tomography: Undergo FDG-PET/CT
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
31894|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Molecular assays on biopsied tissue: Correlative studies
positron emission tomography: Undergo FDG-PET/CT
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
31895|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Molecular assays on biopsied tissue: Correlative studies
positron emission tomography: Undergo FDG-PET/CT
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
31896|NCT02236546|E1|Reported Event|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.
[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Molecular assays on biopsied tissue: Correlative studies
positron emission tomography: Undergo FDG-PET/CT
computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
31897|NCT02236130|B3|Baseline|Total|Total of all reporting groups
31898|NCT02236130|B2|Baseline|Regional|"General Anesthesia combined with regional block
Regional block: Single shot peripheral nerve block
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic Ropivacaine: 0.5% Ropivacaine
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
31899|NCT02236130|B1|Baseline|General|"General Anesthesia only
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
31900|NCT02236130|P2|Participant Flow|Regional|"General Anesthesia combined with regional block
Regional block: Single shot peripheral nerve block
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic Ropivacaine: 0.5% Ropivacaine
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
31901|NCT02236130|P1|Participant Flow|General|"General Anesthesia only
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
31902|NCT02236130|O2|Outcome|Regional|"General Anesthesia combined with regional block
Regional block: Single shot peripheral nerve block
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic Ropivacaine: 0.5% Ropivacaine
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
31903|NCT02236130|O1|Outcome|General|"General Anesthesia only
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
31904|NCT02236130|O2|Outcome|Regional|"General Anesthesia combined with regional block
Regional block: Single shot peripheral nerve block
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic Ropivacaine: 0.5% Ropivacaine
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
31905|NCT02236130|O1|Outcome|General|"General Anesthesia only
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
31906|NCT02236130|E2|Reported Event|Regional|"General Anesthesia combined with regional block
Regional block: Single shot peripheral nerve block
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic Ropivacaine: 0.5% Ropivacaine
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
31907|NCT02236130|E1|Reported Event|General|"General Anesthesia only
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
44537|NCT02130999|O1|Outcome|Oral (20 mg)|
31913|NCT02235831|P2|Participant Flow|Seq 2|DACP MF lenses worn first, followed by DACP (monovision) lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
31914|NCT02235831|P1|Participant Flow|Seq I|DACP MF lenses worn first, followed by DACP MF (Low Add) lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
31915|NCT02235831|O2|Outcome|DACP MF|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
31916|NCT02235831|O1|Outcome|Monovision|Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.
31917|NCT02235831|E3|Reported Event|DACP MF (Low Add)|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
31918|NCT02235831|E2|Reported Event|DACP MF|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
31919|NCT02235831|E1|Reported Event|Monovision|Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.
31920|NCT02235493|B1|Baseline|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
31921|NCT02235493|P1|Participant Flow|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
31922|NCT02235493|O1|Outcome|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
31923|NCT02235493|O1|Outcome|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
31924|NCT02235493|E1|Reported Event|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
31925|NCT02235454|B1|Baseline|Glaucoma Arm|"Consecutive patients with glaucoma will undergo non-invasive OCT imaging
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
31926|NCT02235454|P1|Participant Flow|Glaucoma Arm|"Consecutive patients with glaucoma will undergo non-invasive OCT imaging
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
31927|NCT02235454|O1|Outcome|Glaucoma Arm|"Consecutive patients with glaucoma will undergo non-invasive OCT imaging
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
31928|NCT02235454|E1|Reported Event|Glaucoma Arm|"Consecutive willing patients with glaucoma will undergo non-invasive OCT imaging
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma"
31929|NCT02235311|B3|Baseline|Total|Total of all reporting groups
31930|NCT02235311|B2|Baseline|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31931|NCT02235311|B1|Baseline|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31932|NCT02235311|P2|Participant Flow|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31933|NCT02235311|P1|Participant Flow|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31934|NCT02235311|O2|Outcome|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31935|NCT02235311|O1|Outcome|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31936|NCT02235311|O2|Outcome|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31937|NCT02235311|O1|Outcome|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31938|NCT02235311|O2|Outcome|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31939|NCT02235311|O1|Outcome|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31940|NCT02235311|O2|Outcome|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31941|NCT02235311|O1|Outcome|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31942|NCT02235311|E2|Reported Event|Pantoprazole Once Daily|"Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31943|NCT02235311|E1|Reported Event|Pantoprazole Twice Daily|"Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB"
31944|NCT02235285|B1|Baseline|All Study Participants|Participants were 162-consecutive patients underwent primary breast augmentation by one surgeon.
31945|NCT02235285|P1|Participant Flow|Breast Augmentation,Reoperation|The most common cause of reoperation in breast augmentation is a capsular contracture. So the prevention of capsular contracture is very important in breast augmentation. The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon. The rate of follow-up at 5 years for all patients was 92 percent.
44538|NCT02130999|O2|Outcome|IV (2 mg)|
31946|NCT02235285|O1|Outcome|Breast Augmentation, Reoperation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
31947|NCT02235285|E1|Reported Event|Breast Augmentation, Reoperation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
31948|NCT02235077|B3|Baseline|Total|Total of all reporting groups
31949|NCT02235077|B2|Baseline|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31950|NCT02235077|B1|Baseline|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31951|NCT02235077|P2|Participant Flow|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31952|NCT02235077|P1|Participant Flow|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31953|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31954|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31955|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31956|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31957|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31958|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31959|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31960|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31961|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31962|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31963|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31985|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
44539|NCT02130999|O1|Outcome|Oral (20 mg)|
31987|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
31964|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31965|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31966|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31967|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31968|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31969|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31970|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31971|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31972|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31973|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31974|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31975|NCT02235077|E2|Reported Event|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31976|NCT02235077|E1|Reported Event|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
31977|NCT02235064|B3|Baseline|Total|Total of all reporting groups
31978|NCT02235064|B2|Baseline|Placebo|"Identical appearing capsule daily containing color-matched cellulose only
Placebo: Capsule containing cellulose powder of same color as experimental arm"
31979|NCT02235064|B1|Baseline|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
31980|NCT02235064|P2|Participant Flow|Placebo|"Identical appearing capsule daily containing color-matched cellulose only
Placebo: Capsule containing cellulose powder of same color as experimental arm"
31981|NCT02235064|P1|Participant Flow|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
31982|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
31983|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
31984|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
44540|NCT02130999|O2|Outcome|IV (2 mg)|
31989|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
31990|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
31991|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
31992|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
31993|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
31994|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
31995|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
31996|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
31997|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
31998|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
31999|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
32000|NCT02235064|O2|Outcome|Placebo|Identical appearing capsule daily containing color-matched cellulose only
32001|NCT02235064|O1|Outcome|Sertraline|Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
32002|NCT02235064|O2|Outcome|Placebo|"Identical appearing capsule daily containing color-matched cellulose only
Placebo: Capsule containing cellulose powder of same color as experimental arm"
32003|NCT02235064|O1|Outcome|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
32004|NCT02235064|E2|Reported Event|Placebo|"Identical appearing capsule daily containing color-matched cellulose only
Placebo: Capsule containing cellulose powder of same color as experimental arm"
32005|NCT02235064|E1|Reported Event|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
32006|NCT02234479|B3|Baseline|Total|Total of all reporting groups
32007|NCT02234479|B2|Baseline|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.
MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:
Maintain a balanced environment for healing.
Aids in reducing dermatitis.
Reduce affected area pH.2-3"
32008|NCT02234479|B1|Baseline|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.
Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin
•May be used alone as a skin lubricant or protectant"
32009|NCT02234479|P2|Participant Flow|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.
MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:
Maintain a balanced environment for healing.
Aids in reducing dermatitis.
Reduce affected area pH.2-3"
32010|NCT02234479|P1|Participant Flow|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.
Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin
•May be used alone as a skin lubricant or protectant"
32055|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32058|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32059|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
57301|NCT02033200|P2|Participant Flow|Placebo|placebo
32011|NCT02234479|O2|Outcome|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.
MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:
Maintain a balanced environment for healing.
Aids in reducing dermatitis.
Reduce affected area pH.2-3"
32012|NCT02234479|O1|Outcome|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.
Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin
•May be used alone as a skin lubricant or protectant"
32013|NCT02234479|E2|Reported Event|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.
MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:
Maintain a balanced environment for healing.
Aids in reducing dermatitis.
Reduce affected area pH.2-3"
32014|NCT02234479|E1|Reported Event|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.
Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin
•May be used alone as a skin lubricant or protectant"
32015|NCT02234427|B1|Baseline|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
32016|NCT02234427|P1|Participant Flow|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
32017|NCT02234427|O1|Outcome|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
32018|NCT02234427|E1|Reported Event|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
32019|NCT02234362|B1|Baseline|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32020|NCT02234362|P1|Participant Flow|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32021|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32022|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32023|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32024|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32025|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32056|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
44541|NCT02130999|O1|Outcome|Oral (20 mg)|
32026|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32027|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32028|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32029|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32030|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32031|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32032|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32033|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32034|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32035|NCT02234362|E1|Reported Event|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability
Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
32036|NCT02234011|B1|Baseline|Treatment|No participants enrolled in treatment portion of study, and therefore never completed a baseline visit. One subject completed a screening visit and then withdrew from study due to time commitments.
32037|NCT02234011|P1|Participant Flow|Treatment|No participants enrolled in treatment portion of study.
32038|NCT02234011|O1|Outcome|Treatment|No participants enrolled in treatment portion of study.
32039|NCT02234011|E1|Reported Event|Treatment|"No participants enrolled in treatment portion of study. One subject had a screening visit, but since she never entered the treatment portion of the study and never received the study medication. Because she never had any exposure to the study medication and had no visits other than the initial screening visit, she was never at risk for any adverse events related to study medication.
No adverse events related to study medication were collected since no subjects ever entered the treatment phase of this study."
32040|NCT02233998|B4|Baseline|Total|Total of all reporting groups
32041|NCT02233998|B3|Baseline|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
32042|NCT02233998|B2|Baseline|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
32043|NCT02233998|B1|Baseline|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32044|NCT02233998|P3|Participant Flow|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
32045|NCT02233998|P2|Participant Flow|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
32046|NCT02233998|P1|Participant Flow|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32047|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
32048|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
32049|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32050|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
32051|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
32052|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32053|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
32060|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
32061|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32062|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
32063|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
32064|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32065|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
32066|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
32067|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32068|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
32069|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
32070|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32071|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
32072|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
32073|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32074|NCT02233998|E3|Reported Event|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
32075|NCT02233998|E2|Reported Event|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
32076|NCT02233998|E1|Reported Event|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
32077|NCT02233985|B3|Baseline|Total|Total of all reporting groups
32078|NCT02233985|B2|Baseline|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
32079|NCT02233985|B1|Baseline|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
32080|NCT02233985|P2|Participant Flow|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
32081|NCT02233985|P1|Participant Flow|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
32082|NCT02233985|O2|Outcome|Saline Solution 0.9% (SS 0.9%) Group|We counted the hours from admission of the patient to the pediatric emergency department until hospital discharge. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
32083|NCT02233985|O1|Outcome|Hypertonic Saline Solution 3% (SHS 3%)|We counted the hours from admission of the patient to the pediatric emergency department until hospital discharge. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
32084|NCT02233985|O2|Outcome|Saline Solution 0.9% (SS 0.9%) Group|Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
32085|NCT02233985|O1|Outcome|Hypertonic Saline Solution 3% (HSS 3%) Group|Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
32086|NCT02233985|E2|Reported Event|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
32087|NCT02233985|E1|Reported Event|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
32088|NCT02233842|B1|Baseline|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products"
32089|NCT02233842|P1|Participant Flow|Tobacco Use in Cancer Patients and Survivors|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.
Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
32090|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.
Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
32091|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.
Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
32092|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.
Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
32093|NCT02233842|O1|Outcome|All Participants|"People who have cancer and who have survived cancer
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products."
32094|NCT02233842|E1|Reported Event|Tobacco Use in Cancer Patients and Survivors|"People who have cancer and who have survived cancer
Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products."
32095|NCT02233803|B1|Baseline|Total|The eligible participants were randomised to receive either Regimen A in TP1 and Regimen B in TP2, or Regimen B in TP1 and Regimen A in TP2 according to the randomisation schedule. Both the TPs were separated by a wash out period of 4 weeks. Regimen A: 1 inhalation of budesonide/formoterol fumarate (BFF), 400/12 microgram [mcg] (NEUMOTEROL 400) by single capsule inhaler each morning and evening. Regimen B: 1 inhalation of BFF 320/9 mcg (SYMBICORT FORTE) by turbuhaler inhaler each morning and evening. Additionally all participants were allowed to take rescue medication (salbutamol 100 mcg) during the study.
32096|NCT02233803|P2|Participant Flow|SYMBICORT FORTE/ NEUMOTEROL 400|During TP2, the participants received Regimen B where the eligible participants took, 1 inhalation of BFF 320/9 mcg (SYMBICORT FORTE), by turbuhaler inhaler each morning and evening for 4-Wks. This was followed by a wash out period of 4 Wks, during which all the participants received budesonide DPI 400 mcg (NEUMOTEX 400) twice daily. It was then followed by Regimen A during which eligible participants received, 1 inhalation of NEUMOTEROL 400 by single capsule inhaler each morning and evening, for 4-Wks. Additionally all participants were allowed to take rescue medication (salbutamol 100 mcg) during the study.
32097|NCT02233803|P1|Participant Flow|NEUMOTEROL 400/ SYMBICORT FORTE|During TP1, participants received Regimen A where the eligible participants received, 1 inhalation of budesonide/formoterol fumarate (BFF), 400/12 microgram [mcg] (NEUMOTEROL 400) by single capsule inhaler each morning and evening for 4- weeks (Wks). This was followed by a wash out period of 4 Wks , during which all the participants received budesonide DPI 400 mcg (NEUMOTEX 400) twice daily. The wash-out period was followed by Regimen B during which the eligible participants took, 1 inhalation of BFF 320/9 mcg (SYMBICORT FORTE), by turbuhaler inhaler each morning and evening, for 4-Wks. Additionally all participants were allowed to take rescue medication (salbutamol 100 mcg) during the study.
32098|NCT02233803|O2|Outcome|SYMBICORT FORTE|Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
32099|NCT02233803|O1|Outcome|NEUMOTEROL 400|Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
32100|NCT02233803|O2|Outcome|SYMBICORT FORTE|Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
32101|NCT02233803|O1|Outcome|NEUMOTEROL 400|Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
32102|NCT02233803|O2|Outcome|SYMBICORT FORTE|Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization . The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
32103|NCT02233803|O1|Outcome|NEUMOTEROL 400|Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pressurized metered dose inhaler (pMDI), as rescue medication.
32104|NCT02233803|E2|Reported Event|SYMBICORT FORTE|Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
32105|NCT02233803|E1|Reported Event|NEUMOTEROL 400|Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication.
32106|NCT02233647|B1|Baseline|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32151|NCT02233296|O1|Outcome|Fed Condition|Data presented is all subjects in the fed condition not by sequence of assigned cross-over (fed/fasted or fasted/fed).
32465|NCT02230683|P1|Participant Flow|IDN-6556|IDN-6556 25 mg Dosed twice daily
32152|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
32153|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
32107|NCT02233647|P1|Participant Flow|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition.
Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine."
32108|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32109|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32110|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32111|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32112|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32113|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32114|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32115|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32116|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32117|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32118|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32119|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32120|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32121|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32122|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32123|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32124|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32125|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32126|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32127|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32128|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32129|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32130|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32131|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32132|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32133|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Cocaine was administered acutely after at least seven days of maintenance on each condition.
Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
32134|NCT02233647|E1|Reported Event|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.
Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition.
Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition.
Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.
Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine."
32135|NCT02233309|B1|Baseline|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.
Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.
Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
32136|NCT02233309|P1|Participant Flow|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.
Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.
Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
32137|NCT02233309|O1|Outcome|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.
Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.
Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
32138|NCT02233309|E1|Reported Event|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.
Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.
Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
32139|NCT02233296|B3|Baseline|Total|Total of all reporting groups
32140|NCT02233296|B2|Baseline|Group B|"Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.
Lasmiditan: 2 discrete doses separated by 6 days."
32141|NCT02233296|B1|Baseline|Group A|"Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2
Lasmiditan: 2 discrete doses separated by 6 days."
32142|NCT02233296|P2|Participant Flow|Group B|"Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.
Lasmiditan: 2 discrete doses separated by 6 days."
32143|NCT02233296|P1|Participant Flow|Group A|"Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2
Lasmiditan: 2 discrete doses separated by 6 days."
32144|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
32145|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
32146|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
32147|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
32148|NCT02233296|O2|Outcome|Fasted Condition (n=30)|Data presented is all subjects in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
32149|NCT02233296|O1|Outcome|Fed Condition (n=30)|Data presented is all subjects in the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
32150|NCT02233296|O2|Outcome|Fasted Condition|Data presented is all subjects in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
32154|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
32155|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
32156|NCT02233296|E2|Reported Event|Fasted Condition (n=30)|Subjects were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while subject was in fasted condition are considered equally.
32157|NCT02233296|E1|Reported Event|Fed Condition (n=30)|Subjects were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while subject was in fed condition are considered equally.
32158|NCT02233101|B3|Baseline|Total|Total of all reporting groups
32159|NCT02233101|B2|Baseline|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid
Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
32160|NCT02233101|B1|Baseline|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid
Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
32161|NCT02233101|P2|Participant Flow|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid
Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
32162|NCT02233101|P1|Participant Flow|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid
Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
32163|NCT02233101|O2|Outcome|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid
Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
32164|NCT02233101|O1|Outcome|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid
Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
32165|NCT02233101|O2|Outcome|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid
Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
32166|NCT02233101|O1|Outcome|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid
Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
32167|NCT02233101|E2|Reported Event|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid
Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
32168|NCT02233101|E1|Reported Event|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid
Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
32169|NCT02232880|B1|Baseline|Consented Patients|No patients received treatment prior to study termination
32170|NCT02232880|P1|Participant Flow|Consented Patients|
32171|NCT02232880|O1|Outcome|Consented Patients|
32172|NCT02232880|O1|Outcome|Consented Patients|
32173|NCT02232880|O1|Outcome|Consented Patients|
32174|NCT02232880|O1|Outcome|Consented Patients|
32175|NCT02232880|E1|Reported Event|Consented Patients|No patients received treatment prior to study termination
32176|NCT02232698|B3|Baseline|Total|Total of all reporting groups
32177|NCT02232698|B2|Baseline|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32178|NCT02232698|B1|Baseline|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32179|NCT02232698|P2|Participant Flow|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32212|NCT02231918|B3|Baseline|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32418|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
32215|NCT02231918|P3|Participant Flow|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32216|NCT02231918|P2|Participant Flow|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32180|NCT02232698|P1|Participant Flow|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32181|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32182|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32183|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32184|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32185|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32186|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32187|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32188|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32189|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32190|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32191|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32213|NCT02231918|B2|Baseline|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32214|NCT02231918|B1|Baseline|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32192|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32193|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32194|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32195|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32196|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32197|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32198|NCT02232698|E2|Reported Event|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32199|NCT02232698|E1|Reported Event|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
32200|NCT02232126|B3|Baseline|Total|Total of all reporting groups
32201|NCT02232126|B2|Baseline|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
32202|NCT02232126|B1|Baseline|Usual Care|Usual care consisted of the usual course of care provided to older adults transitioning home from a hospital stay at Huntington Memorial Hospital
32203|NCT02232126|P2|Participant Flow|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
32204|NCT02232126|P1|Participant Flow|Usual Care|
32205|NCT02232126|O2|Outcome|Intervention Group: Opt-outs|Patients randomized to the intervention group that refused the intervention.
32206|NCT02232126|O1|Outcome|Intervention Group: Received Intervention|Patients randomized to the intervention group and received the intervention. SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
32207|NCT02232126|O2|Outcome|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
32208|NCT02232126|O1|Outcome|Usual Care|Usual Care in the present study constitutes usual care that is delivered to older adults transitioning from the hospital to home from Huntington Memorial Hospital.
32209|NCT02232126|E2|Reported Event|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
32210|NCT02232126|E1|Reported Event|Usual Care|Usual care for the present study constituted the usual course of care provided to older adults transitioning from hospital to home from Huntington Memorial Hospital.
32211|NCT02231918|B4|Baseline|Total|Total of all reporting groups
44542|NCT02130999|O2|Outcome|IV (2 mg)|
32217|NCT02231918|P1|Participant Flow|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32218|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32219|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32220|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32221|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32222|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32223|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32224|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32225|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32226|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32227|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32228|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32229|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32230|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32231|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32232|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32233|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32234|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32235|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32236|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32237|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32238|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32239|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32240|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32241|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32242|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32243|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32244|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32245|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32246|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32247|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32248|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32249|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32419|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
32250|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32251|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32252|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32253|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32254|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32255|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32256|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32257|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32258|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32259|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32260|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32261|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32262|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32263|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32264|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32265|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32266|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32267|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32268|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32269|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32270|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32271|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32272|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32273|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32274|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32275|NCT02231918|E3|Reported Event|MIRAPEX® (0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
32276|NCT02231918|E2|Reported Event|MIRAPEX® (0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
32277|NCT02231918|E1|Reported Event|MIRAPEX® (0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
32278|NCT02231177|B1|Baseline|All Subjects|"A randomised, active-controlled, double-blind, 3-way crossover study in patients with COPD (chronic obstructive pulmonary disease). All participants received each of the three treatment arms in a randomly assigned order, the three treatments, which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg
Olodaterol 10 µg.
Tiotropium 5 µg."
32279|NCT02231177|P6|Participant Flow|Tio 5 μg, Olo 10 μg, Tio+Olo 5/10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:
Tiotropium 5 µg.
Olodaterol 10 µg.
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg"
32280|NCT02231177|P5|Participant Flow|Tio 5 μg, Tio+Olo 5/10 μg, Olo 10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:
Tiotropium 5 µg.
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg
Olodaterol 10 µg."
32281|NCT02231177|P4|Participant Flow|Olo 10 μg, Tio 5 μg, Tio+Olo 5/10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:
Olodaterol 10 µg.
Tiotropium 5 µg.
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg"
32282|NCT02231177|P3|Participant Flow|Olo 10 μg, Tio+Olo 5/10 μg, Tio 5 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:
Olodaterol 10 µg.
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg
Tiotropium 5 µg."
57302|NCT02033200|P1|Participant Flow|Active|Stendra 200 mg
32283|NCT02231177|P2|Participant Flow|Tio+Olo 5/10 μg, Tio 5 μg, Olo 10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg
Tiotropium 5 µg.
Olodaterol 10 µg."
32284|NCT02231177|P1|Participant Flow|Tio+Olo 5/10 μg, Olo 10 μg, Tio 5 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg
Olodaterol (Olo) 10 µg.
Tiotropium (Tio) 5 µg."
32285|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32286|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32287|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32288|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32289|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32290|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32291|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32292|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32293|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32294|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32295|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32296|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32297|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32298|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32299|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32300|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32301|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32302|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32303|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32304|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32305|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32306|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32307|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32308|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32309|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32310|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32311|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32897|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32312|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32313|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32314|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32315|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32316|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32317|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32318|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32319|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32320|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32321|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32322|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32323|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32324|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32325|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32326|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32327|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32328|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32329|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32330|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32331|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32332|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32333|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32334|NCT02231177|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32335|NCT02231177|E2|Reported Event|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32336|NCT02231177|E1|Reported Event|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
32337|NCT02231164|B3|Baseline|Total|Total of all reporting groups
32338|NCT02231164|B2|Baseline|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
32359|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32360|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32339|NCT02231164|B1|Baseline|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
32340|NCT02231164|P2|Participant Flow|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
32341|NCT02231164|P1|Participant Flow|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
32342|NCT02231164|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
32343|NCT02231164|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
32344|NCT02231164|E2|Reported Event|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
32345|NCT02231164|E1|Reported Event|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
32346|NCT02229864|B1|Baseline|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
• Scaffold lengths: 8, 12, 18, and 28 mm"
32347|NCT02229864|P1|Participant Flow|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
• Scaffold lengths: 8, 12, 18, and 28 mm"
32348|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32349|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32350|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32351|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32352|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32353|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32354|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32355|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32356|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32357|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32358|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32557|NCT02229487|O1|Outcome|Short Sleepers|Sleep duration as measured by actigraphy =<5.75 h/night
32361|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32362|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32363|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32364|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32365|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32366|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32367|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32368|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32369|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32370|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32371|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32372|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32373|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32374|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32375|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32376|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32377|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32378|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32379|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32380|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32381|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32382|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
32383|NCT02229864|E1|Reported Event|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
• Scaffold lengths: 8, 12, 18, and 28 mm"
32384|NCT02230995|B3|Baseline|Total|Total of all reporting groups
32385|NCT02230995|B2|Baseline|Fed 25mg+1000mg Single/FDC|"Subjects received in period 1 a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
2 treatments separated by a wash-out period of at least 7 days."
32463|NCT02230761|E1|Reported Event|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.
XOPH5 Ointment"
32420|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
32898|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32386|NCT02230995|B1|Baseline|Fed 25mg+1000mg FDC/Single|"Subjects received in period 1 a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
2 treatments separated by a wash-out period of at least 7 days."
32387|NCT02230995|P2|Participant Flow|Fed 25mg+1000mg Single/FDC|"Subjects received in period 1 a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
2 treatments separated by a wash-out period of at least 7 days."
32388|NCT02230995|P1|Participant Flow|Fed 25mg+1000mg FDC/Single|"Subjects received in period 1 a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
2 treatments separated by a wash-out period of at least 7 days."
32389|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
32390|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
32391|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
32392|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
32393|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
32394|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
32395|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
32396|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
32397|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
32398|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
32399|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
32400|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
32401|NCT02230995|E2|Reported Event|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
32402|NCT02230995|E1|Reported Event|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
32403|NCT02230956|B4|Baseline|Total|Total of all reporting groups
32404|NCT02230956|B3|Baseline|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
32405|NCT02230956|B2|Baseline|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
32406|NCT02230956|B1|Baseline|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
32407|NCT02230956|P3|Participant Flow|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
32408|NCT02230956|P2|Participant Flow|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
32409|NCT02230956|P1|Participant Flow|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
32410|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
32411|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
32412|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
32413|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
32414|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
32415|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
32416|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
32417|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
32421|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
32422|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
32423|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
32424|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
32425|NCT02230956|E3|Reported Event|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
32426|NCT02230956|E2|Reported Event|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
32427|NCT02230956|E1|Reported Event|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
32428|NCT02230904|B3|Baseline|Total Title|
32429|NCT02230904|B2|Baseline|Treatment Arm B-A|4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
32430|NCT02230904|B1|Baseline|Treatment Arm A-B|4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
32431|NCT02230904|P2|Participant Flow|Treatment Arm B-A|4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
32432|NCT02230904|P1|Participant Flow|Treatment Arm A-B|4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
32433|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
32434|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
32435|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
32436|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
32437|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
32438|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
32439|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
32440|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
32441|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
32442|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
32443|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
32444|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
32445|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
32446|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
32447|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
32448|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
32449|NCT02230904|E2|Reported Event|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
32450|NCT02230904|E1|Reported Event|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
32451|NCT02230761|B3|Baseline|Total|Total of all reporting groups
32452|NCT02230761|B2|Baseline|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
Placebo"
32453|NCT02230761|B1|Baseline|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.
XOPH5 Ointment"
32454|NCT02230761|P2|Participant Flow|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
Placebo"
32455|NCT02230761|P1|Participant Flow|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.
XOPH5 Ointment"
32456|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
Placebo"
32457|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.
XOPH5 Ointment"
32458|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
Placebo"
32459|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.
XOPH5 Ointment"
32460|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
Placebo"
32461|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.
XOPH5 Ointment"
32462|NCT02230761|E2|Reported Event|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
Placebo"
32464|NCT02230683|B1|Baseline|IDN-6556|IDN-6556 25 mg Dosed twice daily
32466|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
32467|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
32468|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
32469|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
32470|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
32471|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily
32472|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with Baseline HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
32473|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with Baseline HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
32474|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily
32475|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
32476|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
32477|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily with HVPG measurement at Baseline and Day 28
32478|NCT02230683|E1|Reported Event|IDN-6556|IDN-6556 25 mg Dosed twice daily
32479|NCT02230670|B3|Baseline|Total|Total of all reporting groups
32480|NCT02230670|B2|Baseline|Placebo|"Placebo BID
Placebo"
32481|NCT02230670|B1|Baseline|IDN-6556|"25 mg BID of IDN-6556
IDN-6556: 25 mg BID"
32482|NCT02230670|P2|Participant Flow|Placebo|"Placebo BID
Placebo"
32483|NCT02230670|P1|Participant Flow|IDN-6556|"25 mg BID of IDN-6556
IDN-6556: 25 mg BID"
32484|NCT02230670|O2|Outcome|Placebo|"Placebo BID
Placebo"
32485|NCT02230670|O1|Outcome|IDN-6556|"25 mg BID of IDN-6556
IDN-6556: 25 mg BID"
32486|NCT02230670|O2|Outcome|Placebo|"Placebo BID
Placebo"
32487|NCT02230670|O1|Outcome|IDN-6556|"25 mg BID of IDN-6556
IDN-6556: 25 mg BID"
32488|NCT02230670|O2|Outcome|Placebo|"Placebo BID
Placebo"
32489|NCT02230670|O1|Outcome|IDN-6556|"25 mg BID of IDN-6556
IDN-6556: 25 mg BID"
32490|NCT02230670|E2|Reported Event|Placebo (Baseline-Month 3)|Placebo BID (Baseline-Month 3)
32491|NCT02230670|E1|Reported Event|IDN-6556 (Baseline-Month 3)|25 mg BID of IDN-6556 (Baseline-Month 3).
32492|NCT02230540|B1|Baseline|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product A in different positions and measurement of residual urine.
SelfCath (comparator): Catheter for urinary drainage.
Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
32493|NCT02230540|P2|Participant Flow|Sequence B|"Based on results from sequence A, sequence B may or may not be initiated.
Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product B in different positions. Measurement of residual urine at different positions.
SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.
Product B SelfCath and urine bag, Conveen Contour: SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices)."
32494|NCT02230540|P1|Participant Flow|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product A in different positions. Measurement of residual urine at different positions.
SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.
Product A SelfCath and urine bag, Conveen Security+: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
32495|NCT02230540|O1|Outcome|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product A in different positions and measurement of residual urine.
SelfCath (comparator): Catheter for urinary drainage.
Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
32496|NCT02230540|E1|Reported Event|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product A in different positions and measurement of residual urine.
SelfCath (comparator): Catheter for urinary drainage.
Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
32497|NCT02230085|B1|Baseline|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
32498|NCT02230085|P1|Participant Flow|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
32499|NCT02230085|O1|Outcome|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
32500|NCT02230085|E1|Reported Event|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
32501|NCT02229539|B4|Baseline|Total|Total of all reporting groups
32502|NCT02229539|B3|Baseline|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32503|NCT02229539|B2|Baseline|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32504|NCT02229539|B1|Baseline|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32505|NCT02229539|P3|Participant Flow|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32506|NCT02229539|P2|Participant Flow|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32558|NCT02229487|E2|Reported Event|Short Sleeper|Sleep duration as measured by actigraphy =<5.7 h/night
32642|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32507|NCT02229539|P1|Participant Flow|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32508|NCT02229539|O3|Outcome|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32509|NCT02229539|O2|Outcome|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32510|NCT02229539|O1|Outcome|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32511|NCT02229539|E3|Reported Event|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32512|NCT02229539|E2|Reported Event|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32513|NCT02229539|E1|Reported Event|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
32514|NCT02229513|B3|Baseline|Total|Total of all reporting groups
32515|NCT02229513|B2|Baseline|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32516|NCT02229513|B1|Baseline|Control|Normal cesarean technique.
32517|NCT02229513|P2|Participant Flow|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32518|NCT02229513|P1|Participant Flow|Control|Normal cesarean technique.
32519|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32520|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32521|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32522|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32523|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32524|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32525|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32526|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32527|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32528|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32529|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32530|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32559|NCT02229487|E1|Reported Event|Normal Sleeper|Sleep duration as measured by actigraphy >=6.5 h/night
32560|NCT02229461|B8|Baseline|Total|Total of all reporting groups
32561|NCT02229461|B7|Baseline|Non-Randomized|Fifteen participants were not randomized into Treatment Period.
32531|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32532|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32533|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32534|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32535|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32536|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32537|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32538|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32539|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32540|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32541|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32542|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32543|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32544|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32545|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32546|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32547|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32548|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
32549|NCT02229513|E2|Reported Event|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
32550|NCT02229513|E1|Reported Event|Control|Normal cesarean technique.
32551|NCT02229487|B3|Baseline|Total|Total of all reporting groups
32552|NCT02229487|B2|Baseline|Short Sleeper|Sleep duration as measured by actigraphy =<5.75 h/night
32553|NCT02229487|B1|Baseline|Normal Sleeper|Sleep duration as measured by actigraphy >=6.5 h/night
32554|NCT02229487|P2|Participant Flow|Short Sleepers|"Prediabetes patients with short sleep duration (=<5.75 hours/night) as measured objectively
Oral glucose tolerance"
32555|NCT02229487|P1|Participant Flow|Normal Sleepers|"Prediabetes patients with normal sleep duration (>=6.5 hours/ night) as measured objectively
Oral glucose tolerance"
32556|NCT02229487|O2|Outcome|Normal Sleepers|Sleep duration as measured by actigraphy >=6.5h/night
32562|NCT02229461|B6|Baseline|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32563|NCT02229461|B5|Baseline|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32564|NCT02229461|B4|Baseline|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32565|NCT02229461|B3|Baseline|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32566|NCT02229461|B2|Baseline|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32567|NCT02229461|B1|Baseline|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32568|NCT02229461|P6|Participant Flow|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32569|NCT02229461|P5|Participant Flow|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32570|NCT02229461|P4|Participant Flow|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32571|NCT02229461|P3|Participant Flow|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32572|NCT02229461|P2|Participant Flow|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32573|NCT02229461|P1|Participant Flow|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32574|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32575|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32576|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32577|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32578|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32579|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32580|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32581|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32893|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32582|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32583|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32584|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32585|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32586|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32587|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32588|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32589|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32590|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32591|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32592|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32593|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32594|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32595|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32596|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32597|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32598|NCT02229461|E7|Reported Event|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32599|NCT02229461|E6|Reported Event|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32600|NCT02229461|E5|Reported Event|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32601|NCT02229461|E4|Reported Event|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32602|NCT02229461|E3|Reported Event|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32603|NCT02229461|E2|Reported Event|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
32604|NCT02229461|E1|Reported Event|Group 0-IR ASA 81 mg qd in Run-in Period|Participants, subsequently randomized to treatment period, were administered the first dose of immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily at the clinical study site and instructed to take the remaining 5 doses in a fasted state with a full glass of water once daily in the morning in an outpatient setting.
32605|NCT02229318|B1|Baseline|FruitiVits|Daily administration of FruitiVits dietary supplement
32606|NCT02229318|P1|Participant Flow|FruitiVits|Daily administration of FruitiVits dietary supplement
32607|NCT02229318|O1|Outcome|FruitiVits|Administration of FruitiVits dietary supplement
32608|NCT02229318|O1|Outcome|FruitiVits|Daily administration of FruitiVits dietary supplement
32609|NCT02229318|E1|Reported Event|FruitiVits|Daily administration of FruitiVits dietary supplement
32610|NCT02229214|B3|Baseline|Total|Total of all reporting groups
32611|NCT02229214|B2|Baseline|Placebo|"Days 1-28: Placebo
Placebo (sugar pill)"
32612|NCT02229214|B1|Baseline|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia"
32613|NCT02229214|P2|Participant Flow|Placebo|"Days 1-28: Placebo
Sugar Pill"
32614|NCT02229214|P1|Participant Flow|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia"
32615|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo
Placebo (sugar pill)"
32616|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia"
32617|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo
Placebo (sugar pill)"
32618|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia"
32619|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo
Sugar Pill"
32620|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia"
32621|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo
Placebo"
32622|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia"
32623|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo
Sugar Pill"
32624|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia"
32625|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo
Placebo"
32626|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia"
32627|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo
Placebo"
32628|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia"
32629|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo
Sugar Pill"
32630|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia"
32631|NCT02229214|E2|Reported Event|Placebo|"Days 1-28: Placebo
Sugar Pill"
32632|NCT02229214|E1|Reported Event|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia"
32633|NCT02228980|B5|Baseline|Total|Total of all reporting groups
32634|NCT02228980|B4|Baseline|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32635|NCT02228980|B3|Baseline|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32636|NCT02228980|B2|Baseline|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32637|NCT02228980|B1|Baseline|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
32638|NCT02228980|P4|Participant Flow|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32639|NCT02228980|P3|Participant Flow|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32640|NCT02228980|P2|Participant Flow|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32641|NCT02228980|P1|Participant Flow|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
44543|NCT02130999|O1|Outcome|Oral (20 mg)|
32643|NCT02228980|O3|Outcome|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32644|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32645|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
32646|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32647|NCT02228980|O3|Outcome|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32648|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32649|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
32650|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32651|NCT02228980|O3|Outcome|Age 8 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32652|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32653|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
32654|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32655|NCT02228980|O3|Outcome|Age 8 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
32656|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
32657|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
32658|NCT02228980|E4|Reported Event|Group 4|Participants ≥61 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
32659|NCT02228980|E3|Reported Event|Group 3|Participants 18 to 60 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
32660|NCT02228980|E2|Reported Event|Group 2|Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
32661|NCT02228980|E1|Reported Event|Group 1|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
32662|NCT02228720|B1|Baseline|Propel Nova Sinus Implant|Steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
32663|NCT02228720|P1|Participant Flow|Propel Nova Sinus Implant|"Sinus stent with steroid coating (370 ug mometasone furoate)
Propel Nova Sinus Implant: Sinus stent with steroid coating (370 ug mometasone furoate)"
32664|NCT02228720|O1|Outcome|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
32665|NCT02228720|O1|Outcome|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
32666|NCT02228720|O1|Outcome|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
32667|NCT02228720|O1|Outcome|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
32668|NCT02228720|O1|Outcome|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
32669|NCT02228720|E1|Reported Event|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
32670|NCT02228395|B1|Baseline|All Participants|Included all participants who received at least 1 dose of study treatment in any of the intervention periods
32671|NCT02228395|P3|Participant Flow|PF-04958242 0.35 mg, PF-04958242 0.6 mg, Placebo|Participants received 1 single dose of PF-04958242 0.35 mg, PF-04958242 0.6 mg, and placebo orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
32672|NCT02228395|P2|Participant Flow|PF-04958242 0.35 mg, Placebo, PF-04958242 0.8 mg|Participants received 1 single dose of PF-04958242 0.35 mg, placebo, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
32673|NCT02228395|P1|Participant Flow|Placebo, PF-04958242 0.6 Milligrams (mg), PF-04958242 0.8 mg|Participants received 1 single dose of placebo, PF-04958242 0.6 mg, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
32674|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32675|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32676|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32677|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32678|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32679|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
44544|NCT02130999|O2|Outcome|IV (2 mg)|
32680|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32681|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32682|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32683|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32684|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32685|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32686|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32687|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32688|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32689|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32690|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32691|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32692|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32693|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32694|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32695|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32696|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32697|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32698|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32699|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32700|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32701|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32702|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32703|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32704|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
32705|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32706|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32707|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32708|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
32709|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32710|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32711|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32712|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
32713|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32714|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32715|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32716|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
32717|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32718|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32719|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32720|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
32721|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32722|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32723|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32724|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
32725|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32726|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32727|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32728|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
32729|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32730|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32731|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32732|NCT02228395|E4|Reported Event|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
32733|NCT02228395|E3|Reported Event|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
32734|NCT02228395|E2|Reported Event|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
32735|NCT02228395|E1|Reported Event|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
32736|NCT02227810|B3|Baseline|Total|Total of all reporting groups
32737|NCT02227810|B2|Baseline|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
32738|NCT02227810|B1|Baseline|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
32739|NCT02227810|P2|Participant Flow|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
32740|NCT02227810|P1|Participant Flow|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
32741|NCT02227810|O2|Outcome|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
32742|NCT02227810|O1|Outcome|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
32743|NCT02227810|O2|Outcome|Electrical Stimulation|Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
32744|NCT02227810|O1|Outcome|Sham Group|Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
32745|NCT02227810|O2|Outcome|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
32746|NCT02227810|O1|Outcome|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
32747|NCT02227810|O2|Outcome|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
32748|NCT02227810|O1|Outcome|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
32749|NCT02227810|E2|Reported Event|Electrical Stimulation|Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
32892|NCT02226198|O2|Outcome|C-FAS Placebo Not on Apheresis|Cross-over Full Analysis Set, 6 weeks of Placebo
32750|NCT02227810|E1|Reported Event|Sham Group|Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
32752|NCT02227485|B2|Baseline|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patients in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32753|NCT02227485|B1|Baseline|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patients in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32754|NCT02227485|P2|Participant Flow|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32755|NCT02227485|P1|Participant Flow|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32756|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32757|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32758|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32759|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32760|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32761|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32762|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32763|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32764|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32765|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32766|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32767|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32799|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32800|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32768|NCT02227485|E2|Reported Event|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32769|NCT02227485|E1|Reported Event|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
32770|NCT02227368|B3|Baseline|Total|Total of all reporting groups
32771|NCT02227368|B2|Baseline|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
32772|NCT02227368|B1|Baseline|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
32773|NCT02227368|P2|Participant Flow|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
32774|NCT02227368|P1|Participant Flow|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
32775|NCT02227368|O2|Outcome|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
32776|NCT02227368|O1|Outcome|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
32777|NCT02227368|O2|Outcome|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
32778|NCT02227368|O1|Outcome|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
32779|NCT02227368|E2|Reported Event|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
32780|NCT02227368|E1|Reported Event|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
32781|NCT02227121|B1|Baseline|Enrolled Subjects|All subjects consented for the study.
32782|NCT02227121|P1|Participant Flow|Enrolled Subjects|All subjects consented for the study.
32783|NCT02227121|O1|Outcome|VF Induction and Defibrillation|"Ventricular Fibrillation (VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.
Defibrillation following induction of VF: Up to 10 VF induction attempts followed by shock(s) delivered by an externally placed Implantable Cardioverter/Defibrillator (ICD) and/or external defibrillator."
32784|NCT02227121|E1|Reported Event|Enrolled Subjects|All subjects consented into the study
32785|NCT02227108|B1|Baseline|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32786|NCT02227108|P1|Participant Flow|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32787|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32788|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32789|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32790|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32791|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32792|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32793|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32794|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32795|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32796|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32797|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32798|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
44545|NCT02130999|O1|Outcome|Oral (20 mg)|
32801|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32802|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32803|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32804|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32805|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32806|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32807|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32808|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32809|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32810|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32811|NCT02227108|E1|Reported Event|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
32812|NCT02226562|B3|Baseline|Total|Total of all reporting groups
32813|NCT02226562|B2|Baseline|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
32814|NCT02226562|B1|Baseline|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
32815|NCT02226562|P2|Participant Flow|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
32816|NCT02226562|P1|Participant Flow|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
32817|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
32818|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
32819|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
32820|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
32821|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
32822|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
32823|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
32824|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
32825|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
32826|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
32827|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
32828|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
32829|NCT02226562|E2|Reported Event|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
32830|NCT02226562|E1|Reported Event|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
32831|NCT02226549|B3|Baseline|Total|Total of all reporting groups
32832|NCT02226549|B2|Baseline|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
32833|NCT02226549|B1|Baseline|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
32891|NCT02226198|O1|Outcome|M-FAS Rosuvastatin|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
44546|NCT02130999|O2|Outcome|IV (2 mg)|
32834|NCT02226549|P2|Participant Flow|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
57303|NCT02033200|O2|Outcome|Placebo|placebo
32835|NCT02226549|P1|Participant Flow|LDV/SOF+VDV|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet + vedroprevir (VDV) 80 mg tablet once daily for 8 weeks
32836|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
32837|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
32838|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
32839|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
32840|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
32841|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
32842|NCT02226549|E2|Reported Event|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
32843|NCT02226549|E1|Reported Event|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
32844|NCT02226198|B1|Baseline|Cross-over|Cross-over phase
32845|NCT02226198|P3|Participant Flow|Placebo First Then Rosuva|Relevant for the cross-over phase
32846|NCT02226198|P2|Participant Flow|Rosuva First Then Placebo|Relevant for the cross-over phase
32847|NCT02226198|P1|Participant Flow|Overall|Relevant for the lead-in and maintenance phases
32848|NCT02226198|O1|Outcome|Safety Analysis Set|Safety Analysis Set
32849|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
32850|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin
32851|NCT02226198|O3|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32852|NCT02226198|O2|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32853|NCT02226198|O1|Outcome|Safety Analysis Set|Safety Analysis Set
32854|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
32855|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin
32856|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32857|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32858|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32859|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32860|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32861|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32862|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32863|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32864|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32865|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32866|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32867|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32868|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
32869|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
32870|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
32871|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
32872|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
32873|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
32874|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
32875|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
32876|NCT02226198|O4|Outcome|Pla/Ros >ULN|Safety Analysis Set, starting cross-over phase with 6 weeks of placebo
32877|NCT02226198|O3|Outcome|Pla/Ros <LLN|Safety Analysis Set, starting cross-over phase with 6 weeks of placebo
32878|NCT02226198|O2|Outcome|Ros/Pla >ULN|Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
32879|NCT02226198|O1|Outcome|Ros/Pla <LLN|Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
32880|NCT02226198|O3|Outcome|Maintenance Phase|Maintenance phase, Safety analysis set
32881|NCT02226198|O2|Outcome|Cross-over Phase|Cross-over phase, Safety analysis set
32882|NCT02226198|O1|Outcome|Lead-in|Optional 10mg lead-in phase, Safety analysis set
32883|NCT02226198|O3|Outcome|Maintenance|Maintenance Phase, Safety analysis set
32884|NCT02226198|O2|Outcome|Cross-over Phase|Cross-over phase, Safety analysis set
32885|NCT02226198|O1|Outcome|Lead-in|Optional 10mg lead-in phase, Safety analysis set
32886|NCT02226198|O2|Outcome|Maintenance Phase|Measurement taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.
32887|NCT02226198|O1|Outcome|Cross-over Phase|Measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase
32888|NCT02226198|O2|Outcome|M-FAS Placebo|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo
32889|NCT02226198|O1|Outcome|M-FAS Rosuvastatin|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
32890|NCT02226198|O2|Outcome|M-FAS Placebo|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo
32894|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32895|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32899|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32900|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32901|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32902|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32903|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32904|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32905|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32906|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32907|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32908|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32909|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32910|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32911|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32912|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32913|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32914|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
32915|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
32916|NCT02226198|E3|Reported Event|Maintenance|Maintenance phase
32917|NCT02226198|E2|Reported Event|Cross-over|Cross-over phase
32918|NCT02226198|E1|Reported Event|Lead-in|Lead-in
32919|NCT02226003|B4|Baseline|Total|Total of all reporting groups
32920|NCT02226003|B3|Baseline|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32921|NCT02226003|B2|Baseline|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32922|NCT02226003|B1|Baseline|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
32923|NCT02226003|P3|Participant Flow|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32924|NCT02226003|P2|Participant Flow|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32925|NCT02226003|P1|Participant Flow|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
32926|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32927|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32928|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
32929|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32930|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32931|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
32932|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32933|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32934|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
32935|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32936|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32937|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
33078|NCT02224508|O2|Outcome|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
32938|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32939|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
33080|NCT02224508|O2|Outcome|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
32940|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
32941|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32942|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32943|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
32944|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32945|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32946|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
32947|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32948|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32949|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
32950|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32951|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32952|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
32953|NCT02226003|E3|Reported Event|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32954|NCT02226003|E2|Reported Event|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
32955|NCT02226003|E1|Reported Event|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
32956|NCT02225860|B3|Baseline|Total|Total of all reporting groups
32957|NCT02225860|B2|Baseline|Control|Continue with usual diet
32958|NCT02225860|B1|Baseline|Diet and Water Adjustment|"Reduction in dietary salt and protein intake
Diet and water adjustment"
32959|NCT02225860|P2|Participant Flow|Control|Continue with usual diet
32960|NCT02225860|P1|Participant Flow|Diet and Water Adjustment|"Reduction in dietary salt and protein intake
Diet and water adjustment"
32961|NCT02225860|O2|Outcome|Control|Continue with usual diet
32962|NCT02225860|O1|Outcome|Diet and Water Adjustment|"Reduction in dietary salt and protein intake
Diet and water adjustment: The dietary intervention consisted of three elements: low sodium (1500 mg/day), low protein (daily protein dietary allowance of 0.8 gram/kg body weight), and low urea (avoidance of preservatives, food additives, bulking agents, and chewing gum). Protein was factored by measured body weight to mirror the estimated average requirement (EAR) of healthy adults which is set on a grams per kilogram basis"
32963|NCT02225860|O2|Outcome|Control|Continue with usual diet
32964|NCT02225860|O1|Outcome|Diet and Water Adjustment|"Reduction in dietary salt and protein intake
Diet and water adjustment"
32965|NCT02225860|O2|Outcome|Control|Continue with usual diet
32966|NCT02225860|O1|Outcome|Diet and Water Adjustment|"Reduction in dietary salt and protein intake
Diet and water adjustment"
32967|NCT02225860|E2|Reported Event|Control|Continue with usual diet
32968|NCT02225860|E1|Reported Event|Diet and Water Adjustment|"Reduction in dietary salt and protein intake
Diet and water adjustment"
32969|NCT02224820|B1|Baseline|Intravenous IdeS|"One or two doses of IdeS in ascending doses
IdeS"
32970|NCT02224820|P1|Participant Flow|Intravenous IdeS|One or two doses of IdeS in ascending doses.
32971|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
32972|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
32973|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
32974|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
32975|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
32976|NCT02224820|E1|Reported Event|Intravenous IdeS|One or two doses of IdeS in ascending doses.
32977|NCT02224664|B1|Baseline|Overall Study|All participants who received a single oral dose of L-Dopa tablet/capsule (up to a maximum dose of 250 mg, based on investigator’s discretion) in lead-in period and/or single oral dose of PF-06649751 tablet (3 mg, 5 mg, 15 mg and 25 mg) in dose escalation period.
32978|NCT02224664|P5|Participant Flow|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33483|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
32979|NCT02224664|P4|Participant Flow|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
32980|NCT02224664|P3|Participant Flow|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
32981|NCT02224664|P2|Participant Flow|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
32982|NCT02224664|P1|Participant Flow|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
32983|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
32984|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
32985|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
32986|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
32987|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
32988|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
32989|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
32990|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
32991|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
32992|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
32993|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
32994|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
32995|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
32996|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
32997|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
32998|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
32999|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33195|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33046|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33000|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33001|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33002|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33003|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33004|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33005|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33006|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33007|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33008|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33009|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33010|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33011|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33012|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33013|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33014|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33015|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33016|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33017|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33018|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33019|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33020|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33021|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33022|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33077|NCT02224508|P1|Participant Flow|Opioid Risk Reduction Initiative|Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
33023|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33024|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33025|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33026|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33027|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33028|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33029|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33030|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33031|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33032|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33033|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33034|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33035|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33036|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33037|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33038|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33039|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33040|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33041|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33042|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33043|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33044|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33045|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33047|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33048|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33049|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33050|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33051|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33052|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33053|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33054|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33055|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33056|NCT02224664|E5|Reported Event|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
33057|NCT02224664|E4|Reported Event|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
33058|NCT02224664|E3|Reported Event|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
33059|NCT02224664|E2|Reported Event|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
33060|NCT02224664|E1|Reported Event|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
33061|NCT02224625|B1|Baseline|2% CHG, Vehicle, DynaHex, Saline|Chlorhexidine Gluconate 2% Cloth Solution Vehicle solution of CHG cloth DynaHex 2% CHG solution 0.9% Saline Sodium Lauryl Sulfate (only used in Irritation Study)
33062|NCT02224625|P1|Participant Flow|2% CHG Cloth, Vehicle, DynaHex, Saline, SLS|Chlorhexidine Gluconate 2% cloth solution Vehicle solution of 2% CHG cloth DynaHex (2% CHG) 0.9% Saline Sodium Lauryl Sulfate
33063|NCT02224625|O5|Outcome|Sodium Lauryl Sulfate (SLS)|"Sodium lauryl sulfate to produce mild irritation as a positive control
SLS: Provides a slight irritation for a positive control"
33064|NCT02224625|O4|Outcome|Saline|"0.9% sodium chloride
Saline: Negative control"
33065|NCT02224625|O3|Outcome|DynaHex (2% CHG)|"Chlorhexidine Gluconate 2% solution
Active Comparator: 2% CHG solution"
33066|NCT02224625|O2|Outcome|Vehicle Cloth|"Excipients on cloth
Vehicle Cloth: Excipients from CHG cloth only"
33067|NCT02224625|O1|Outcome|2% CHG Cloth|"Chlorhexidine Gluconate 2%
2% CHG Cloth: CHG solution on cloth"
33068|NCT02224625|E5|Reported Event|Sodium Lauryl Sulfate (SLS)|"Sodium lauryl sulfate to produce mild irritation as a positive control
SLS: Provides a slight irritation for a positive control"
33069|NCT02224625|E4|Reported Event|Saline|"0.9% sodium chloride
Saline: Negative control"
33070|NCT02224625|E3|Reported Event|DynaHex (2% CHG)|"Chlorhexidine Gluconate 2% solution
Active Comparator: 2% CHG solution"
33071|NCT02224625|E2|Reported Event|Vehicle Cloth|"Excipients on cloth
Vehicle Cloth: Excipients from CHG cloth only"
33072|NCT02224625|E1|Reported Event|2% CHG Cloth|"Chlorhexidine Gluconate 2%
2% CHG Cloth: CHG solution on cloth"
33073|NCT02224508|B3|Baseline|Total|Total of all reporting groups
33074|NCT02224508|B2|Baseline|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
33075|NCT02224508|B1|Baseline|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
33076|NCT02224508|P2|Participant Flow|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
44547|NCT02130999|O1|Outcome|Oral (20 mg)|
33079|NCT02224508|O1|Outcome|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
33081|NCT02224508|O1|Outcome|Opioid Risk Reduction Initiative|Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
33082|NCT02224508|O2|Outcome|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
33083|NCT02224508|O1|Outcome|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
33084|NCT02224508|E2|Reported Event|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
33085|NCT02224508|E1|Reported Event|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
33086|NCT02224404|B1|Baseline|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
33087|NCT02224404|P1|Participant Flow|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
33088|NCT02224404|O1|Outcome|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
33089|NCT02224404|O1|Outcome|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
33090|NCT02224404|E1|Reported Event|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
33091|NCT02224053|B1|Baseline|AZD9291 and Omeprazole|Sequential treatments periods of AZD9291 + omeprazole (including a washout) followed by AZD9291 alone.
33092|NCT02224053|P1|Participant Flow|AZD9291 and Omeprazole|Sequential treatments periods of AZD9291 + omeprazole (including a washout) followed by AZD9291 alone.
33093|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33094|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33095|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33096|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33097|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33098|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33099|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33100|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33101|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33102|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33103|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33104|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33105|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33106|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33107|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33108|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33109|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33110|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33111|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33112|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33113|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33114|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33115|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33116|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33117|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33118|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33119|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33120|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33121|NCT02224053|E2|Reported Event|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
33122|NCT02224053|E1|Reported Event|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
33146|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
33147|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
44548|NCT02130999|O2|Outcome|IV (2 mg)|
33123|NCT02223871|B1|Baseline|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes occurred 16 days after ACT-451840 administration (or earlier if required).
33124|NCT02223871|P1|Participant Flow|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
33125|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
33126|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
33127|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
33128|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
33129|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
33130|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
33131|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
33132|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
33133|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
33134|NCT02223871|E1|Reported Event|ACT-451840 500 mg|The eight subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes on Day 0 and received 500 mg of ACT-451840 on Day 7. All of them received six doses of Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, as per protocol.
33135|NCT02223754|B3|Baseline|Total|Total of all reporting groups
33136|NCT02223754|B2|Baseline|Lotrafilcon B / Etafilcon A|Subjects that were randomized to this sequence and were dispensed a study lens.
33137|NCT02223754|B1|Baseline|Etafilcon A / Lotrafilcon B|Subjects that were randomized to this sequence and were dispensed a study lens.
33138|NCT02223754|P2|Participant Flow|Lotrafilcon B/ Etafilcon A|Subjects were randomized to one of two lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
33139|NCT02223754|P1|Participant Flow|Etafilcon A / Lotrafilcon B|Subjects were randomized to one of two lens sequences. Subjects first received the etafilcon A contact lens and then received the Control lens (lotrafilcon B contact lens.
33140|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B during either the first or second period of the study.
33141|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
33142|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
33143|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
33144|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
33145|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
33148|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
33149|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
33150|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
33151|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
33152|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B during either the first or second period of the study.
33153|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
33154|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
33155|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
33156|NCT02223754|E2|Reported Event|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
33157|NCT02223754|E1|Reported Event|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
33158|NCT02223715|B1|Baseline|Clostridium Difficile Infection|Patient with Clostridium Difficile Infection
33159|NCT02223715|P1|Participant Flow|Clostridium Difficile Infection|To characterize the ｍanagement and outcome of Clostridium Difficile Infection in asian pacific countries
33160|NCT02223715|O1|Outcome|Recurrence or Not After 2 Months Follow-up|
33161|NCT02223715|O1|Outcome|Clinical Complication|
33162|NCT02223715|O1|Outcome|Status at the End of CDI Episode|To characterize the management and outcome of Clostridium Difficile Infection
33163|NCT02223715|O1|Outcome|Medical History|To characterize the management and outcome of Clostridium Difficile Infection
33164|NCT02223715|E1|Reported Event|Clostridium Difficile Infection|Patient with Clostridium Difficile Infection
33165|NCT02223650|B3|Baseline|Total|Total of all reporting groups
33166|NCT02223650|B2|Baseline|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33167|NCT02223650|B1|Baseline|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33168|NCT02223650|P2|Participant Flow|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33169|NCT02223650|P1|Participant Flow|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33170|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33171|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33172|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33173|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33174|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33175|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33176|NCT02223650|O2|Outcome|Non-overminus Treatment|Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.
33177|NCT02223650|O1|Outcome|Overminus Treatment|Spectacle-related questions at follow up apply to all overminus group participants.
33178|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33179|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33180|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33181|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33182|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33183|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33184|NCT02223650|O2|Outcome|Non-overminus Treatment|Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.
33185|NCT02223650|O1|Outcome|Overminus Treatment|Spectacle-related questions at follow up apply to all overminus group participants.
33186|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33187|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33188|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33189|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33190|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33191|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33192|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33193|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33194|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33196|NCT02223650|E2|Reported Event|Non-overminus Treatment|"spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles"
33197|NCT02223650|E1|Reported Event|Overminus Treatment|"2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles"
33198|NCT02223429|B5|Baseline|Total|Total of all reporting groups
33424|NCT02222129|E2|Reported Event|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.
liposomal bupivacaine"
33199|NCT02223429|B4|Baseline|Placebo First, Followed by AVP|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
33200|NCT02223429|B3|Baseline|AVP First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33201|NCT02223429|B2|Baseline|Placebo First, Followed by OT|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
33202|NCT02223429|B1|Baseline|OT First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33203|NCT02223429|P4|Participant Flow|Placebo First, Followed by AVP|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
33204|NCT02223429|P3|Participant Flow|AVP First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33205|NCT02223429|P2|Participant Flow|Placebo First, Followed by OT|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
33206|NCT02223429|P1|Participant Flow|OT First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33207|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
33208|NCT02223429|O1|Outcome|Vasopressin (AVP)|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33209|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
33210|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33211|NCT02223429|O2|Outcome|Placebo|All participants who were administered placebo at any time point during the study and have completed the cry rating scale.
33212|NCT02223429|O1|Outcome|Vasopressin (AVP)|All participants who were administered AVP at any time point during the study and have completed the cry rating scale.
33213|NCT02223429|O2|Outcome|Placebo|All participants who were administered placebo at any time point during the study and have completed the cry rating scale.
33214|NCT02223429|O1|Outcome|Oxytocin|All participants who were administered oxytocin at any time point during the study and have completed the cry rating scale.
33215|NCT02223429|O1|Outcome|OT + Placebo Group|The OT + placebo group self-administered no more than 1 ml solution of oxytocin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo was counterbalanced across subjects, such that half received OT first, and half received OT second.
33216|NCT02223429|O1|Outcome|AVP + Placebo|The AVP + placebo group self-administered no more than 1 ml solution of vasopressin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo was counterbalanced across subjects, such that half received AVP first, and half received AVP second.
33217|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
33218|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33219|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
33220|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33221|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
33222|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33223|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
33335|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33224|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33225|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
33226|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33227|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
33228|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
33229|NCT02223429|E4|Reported Event|Placebo of AVP|"The placebo of AVP group self-administered no more than 1 ml solution of placebo of AVP in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.
This group also went through the AVP treatment."
33230|NCT02223429|E3|Reported Event|Placebo of OT|"The placebo of OT group self-administered no more than 1 ml solution of placebo of OT in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.
This group also went through the OT treatment."
33231|NCT02223429|E2|Reported Event|AVP Treatment|"The AVP group self-administered no more than 1 ml solution of vasopressin in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.
This group also went through the Placebo of AVP treatment."
33232|NCT02223429|E1|Reported Event|OT Treatment|"The OT group self-administered no more than 1 ml solution of oxytocin in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.
This group also went through the Placebo of OT treatment."
33300|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33490|NCT02220764|B1|Baseline|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses
Teeth abutment"
36111|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
33491|NCT02220764|P2|Participant Flow|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses
Implant abutments"
33301|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
44549|NCT02130999|O1|Outcome|Oral (20 mg)|
33429|NCT02221947|P2|Participant Flow|Placebo|"single dose of placebo, intravenous infusion over 1 hour
Placebo: Placebo, single dose via intravenous infusion over 1 hour."
33288|NCT02223260|B1|Baseline|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33289|NCT02223260|P1|Participant Flow|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33290|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33291|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33292|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33293|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33294|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33295|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33296|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33336|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
57304|NCT02033200|O1|Outcome|Active|Stendra 200 mg
33297|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33298|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33299|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33302|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33303|NCT02223260|E1|Reported Event|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
33304|NCT02223065|B3|Baseline|Total|Total of all reporting groups
33305|NCT02223065|B2|Baseline|Treatment BA|"Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions."
33306|NCT02223065|B1|Baseline|Treatment AB|"Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions."
33307|NCT02223065|P2|Participant Flow|Treatment BA|"Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions."
33308|NCT02223065|P1|Participant Flow|Treatment AB|"Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions."
33309|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
33310|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
33311|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
33312|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
33313|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
33314|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
33315|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
33316|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
33317|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
33318|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
33319|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
33320|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
33321|NCT02223065|E2|Reported Event|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
33322|NCT02223065|E1|Reported Event|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
33323|NCT02222870|B3|Baseline|Total|Total of all reporting groups
33324|NCT02222870|B2|Baseline|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33325|NCT02222870|B1|Baseline|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33326|NCT02222870|P2|Participant Flow|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33327|NCT02222870|P1|Participant Flow|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33328|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33329|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33330|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33331|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33332|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33333|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33334|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33419|NCT02222129|B1|Baseline|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.
Bupivacaine"
33337|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33338|NCT02222870|E2|Reported Event|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33339|NCT02222870|E1|Reported Event|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
33340|NCT02222818|B3|Baseline|Total|Total of all reporting groups
33492|NCT02220764|P1|Participant Flow|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses
Teeth abutment"
33341|NCT02222818|B2|Baseline|Group B: CAFRPlus First|"Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
33342|NCT02222818|B1|Baseline|Group A: CAFR First|"Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
33343|NCT02222818|P2|Participant Flow|Group B: CAFRPlus First|"Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
33344|NCT02222818|P1|Participant Flow|Group A: CAFR First|"Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
33345|NCT02222818|O2|Outcome|CAFRPlus ON|Percentage of effective CRT pacing during AF when CAFRPlus is ON
33346|NCT02222818|O1|Outcome|CAFR ON|Percentage of effective CRT pacing during AF when CAFR is ON
33347|NCT02222818|O2|Outcome|CAFRPlus ON|Percentage of effective CRT pacing during AF when CAFRPlus is ON
33348|NCT02222818|O1|Outcome|CAFR ON|Percentage of effective CRT pacing during AF when CAFR is ON
33349|NCT02222818|E1|Reported Event|All Enrolled Subjects|All subjects enrolled in the CRTee study.
33350|NCT02222558|B1|Baseline|All Study Participants|"Study participants start in Period 1 and proceed to Period 2 and then Period 3 Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33351|NCT02222558|P6|Participant Flow|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33352|NCT02222558|P5|Participant Flow|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33353|NCT02222558|P4|Participant Flow|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33354|NCT02222558|P3|Participant Flow|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33355|NCT02222558|P2|Participant Flow|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
33420|NCT02222129|P2|Participant Flow|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.
liposomal bupivacaine"
57305|NCT02033200|O2|Outcome|Placebo|placebo
33356|NCT02222558|P1|Participant Flow|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
33357|NCT02222558|O6|Outcome|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33493|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses
Implant abutments"
33358|NCT02222558|O5|Outcome|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33359|NCT02222558|O4|Outcome|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33360|NCT02222558|O3|Outcome|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33361|NCT02222558|O2|Outcome|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
33362|NCT02222558|O1|Outcome|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
33363|NCT02222558|E6|Reported Event|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33364|NCT02222558|E5|Reported Event|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33365|NCT02222558|E4|Reported Event|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33366|NCT02222558|E3|Reported Event|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
33367|NCT02222558|E2|Reported Event|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
33368|NCT02222558|E1|Reported Event|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
33369|NCT02222246|B3|Baseline|Total|Total of all reporting groups
33370|NCT02222246|B2|Baseline|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33371|NCT02222246|B1|Baseline|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33421|NCT02222129|P1|Participant Flow|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.
Bupivacaine"
33372|NCT02222246|P2|Participant Flow|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33430|NCT02221947|P1|Participant Flow|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour
Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
33373|NCT02222246|P1|Participant Flow|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent National Heart, Lung, and Blood Institute (NHBLI) recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a Sickle Cell Disease (SCD) specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33374|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33375|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33376|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33377|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33378|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33379|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33422|NCT02222129|O2|Outcome|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.
liposomal bupivacaine"
33423|NCT02222129|O1|Outcome|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.
Bupivacaine"
57306|NCT02033200|O1|Outcome|Active|Stendra 200 mg
33380|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33431|NCT02221947|O2|Outcome|Placebo|"single dose of placebo, intravenous infusion over 1 hour
Placebo: Placebo, single dose via intravenous infusion over 1 hour."
33432|NCT02221947|O1|Outcome|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour
Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
33433|NCT02221947|E2|Reported Event|Placebo|"single dose of placebo, intravenous infusion over 1 hour
Placebo: Placebo, single dose via intravenous infusion over 1 hour."
33381|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33382|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33383|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33384|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33385|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33386|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33387|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33388|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33434|NCT02221947|E1|Reported Event|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour
Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
33435|NCT02221648|B3|Baseline|Total|Total of all reporting groups
33436|NCT02221648|B2|Baseline|AbobotulinumtoxinA Treatment|All subjects will receive intervention injections with the study drug abobotulinumtoxinA.
33494|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses
Teeth abutment"
33389|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33390|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33391|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33392|NCT02222246|O2|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33393|NCT02222246|O1|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33394|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33395|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33396|NCT02222246|O2|Outcome|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33437|NCT02221648|B1|Baseline|Placebo|Subjects will be randomization to receive injections with either the study drug (incobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
33495|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses
Implant abutments"
33496|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses
Teeth abutment"
44550|NCT02130999|O1|Outcome|Absolute Bioavailability|
33397|NCT02222246|O1|Outcome|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33398|NCT02222246|E2|Reported Event|Standard Dose of Morphine Sulfate or Hydromorphone|"A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
Hydromorphone (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Morphine Sulfate (Standardized, weight-based dosing): Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based)."
33399|NCT02222246|E1|Reported Event|Patient Specific Dose of Morphine Sulfate or Hydromorphone|"A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 6 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
Hydromorphone (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Morphine Sulfate (Patient Specific dosing): Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team."
33400|NCT02222207|B1|Baseline|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
33401|NCT02222207|P1|Participant Flow|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
33402|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
33403|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
33404|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
33405|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
33406|NCT02222207|E1|Reported Event|Part A Regorafenib|Participants self-administered 30 mg/mL, 25 mcL, 1 drop of regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
33407|NCT02222181|B1|Baseline|Treatment|patients in treatment for Alzheimer's disease.
33408|NCT02222181|P1|Participant Flow|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
33409|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
33410|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
33411|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
33412|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
33413|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
33414|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
33415|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
33416|NCT02222181|E1|Reported Event|Treatment|Do not apply.
33417|NCT02222129|B3|Baseline|Total|Total of all reporting groups
33418|NCT02222129|B2|Baseline|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.
liposomal bupivacaine"
33425|NCT02222129|E1|Reported Event|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.
Bupivacaine"
33426|NCT02221947|B3|Baseline|Total|Total of all reporting groups
33427|NCT02221947|B2|Baseline|Placebo|"single dose of placebo, intravenous infusion over 1 hour
Placebo: Placebo, single dose via intravenous infusion over 1 hour."
33428|NCT02221947|B1|Baseline|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour
Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
33489|NCT02220764|B2|Baseline|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses
Implant abutments"
33438|NCT02221648|P2|Participant Flow|ArbobotulinumtoxinA Treatment|"Subjects will receive intervention injections with the study drug abobotulinumtoxinA.
AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment."
33439|NCT02221648|P1|Participant Flow|Placebo|Subjects will be randomized to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
33440|NCT02221648|O2|Outcome|AbobotulinumtoxinA Treatment|"Subjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA.
AbobotulinumtoxinA Treatment: Subjects receive intervention injections with the study drug arbobotulinumtoxinA."
33441|NCT02221648|O1|Outcome|Placebo|"Subjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive.
Placebo: Subjects will be randomization to receive either the study drug or the placebo group."
33442|NCT02221648|O2|Outcome|botulinumtoxinA Treatment|Subjects received botox injection.
33443|NCT02221648|O1|Outcome|Placebo|Study group received placebo injection.
33444|NCT02221648|O2|Outcome|AbobotulinumtoxinA Treatment|All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
33445|NCT02221648|O1|Outcome|Placebo|Subjects will be randomized to receive injections with saline.
33446|NCT02221648|E2|Reported Event|ArbobotulinumtoxinA Treatment|AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
33447|NCT02221648|E1|Reported Event|Placebo|Subjects will be randomized to receive injections with placebo.
33448|NCT02221557|B1|Baseline|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
33449|NCT02221557|P1|Participant Flow|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
33450|NCT02221557|O1|Outcome|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
33451|NCT02221557|E1|Reported Event|New Alloplastic Bone Graft Material|easy-graft (beta-Tricalcium Phosphate)
33452|NCT02220998|B3|Baseline|Total|Total of all reporting groups
33453|NCT02220998|B2|Baseline|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33454|NCT02220998|B1|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
33455|NCT02220998|P2|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33456|NCT02220998|P1|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
33457|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33458|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
33459|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33460|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
33461|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33462|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
33463|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33464|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
33465|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33466|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
33467|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33468|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
33469|NCT02220998|E2|Reported Event|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
33470|NCT02220998|E1|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
33471|NCT02220920|B3|Baseline|Total|Total of all reporting groups
33472|NCT02220920|B2|Baseline|Placebo＋Insulin|Placebo, once daily for 16 weeks
33473|NCT02220920|B1|Baseline|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
33474|NCT02220920|P2|Participant Flow|Placebo＋Insulin|Placebo, once daily for 16 weeks
33475|NCT02220920|P1|Participant Flow|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
33476|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
33477|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
33478|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
33479|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
33480|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
33481|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
33482|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
33484|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
33485|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
33486|NCT02220920|E2|Reported Event|Placebo＋Insulin|Placebo, once daily for 16 weeks
33487|NCT02220920|E1|Reported Event|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
33488|NCT02220764|B3|Baseline|Total|Total of all reporting groups
44551|NCT02130999|E3|Reported Event|All Subjects|
33497|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses
Implant abutments"
33498|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses
Teeth abutment"
33499|NCT02220764|E2|Reported Event|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses
Implant abutments"
33500|NCT02220764|E1|Reported Event|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses
Teeth abutment"
33501|NCT02220205|B3|Baseline|Total|Total of all reporting groups
33502|NCT02220205|B2|Baseline|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.
Manufacturer model"
33503|NCT02220205|B1|Baseline|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.
PelvicSim"
33504|NCT02220205|P2|Participant Flow|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.
Manufacturer model"
33505|NCT02220205|P1|Participant Flow|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.
PelvicSim"
33506|NCT02220205|O2|Outcome|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.
Manufacturer model"
33507|NCT02220205|O1|Outcome|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.
PelvicSim"
33508|NCT02220205|O2|Outcome|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.
Manufacturer model"
33509|NCT02220205|O1|Outcome|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.
PelvicSim"
33510|NCT02220205|E2|Reported Event|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.
Manufacturer model"
33511|NCT02220205|E1|Reported Event|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.
PelvicSim"
33512|NCT02219997|B3|Baseline|Total|Total of all reporting groups
33513|NCT02219997|B2|Baseline|Clear IOL|Clear IOL with blue light filter clip-on glasses and clear clip-on glasses, worn in a cross-over fashion, as randomized, for 4 hours total
33514|NCT02219997|B1|Baseline|AcrySof IQ IOL|ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
33515|NCT02219997|P3|Participant Flow|Clear IOL: Placebo Filter First, Then BLF|Clear IOL with clear clip-on glasses worn first and blue light filter clip-on glasses worn second for 4 hours total
33516|NCT02219997|P2|Participant Flow|Clear IOL: BLF First, Then Placebo Filter|Clear IOL with blue light filter clip-on glasses worn first and clear clip-on glasses worn second for 4 hours total
33517|NCT02219997|P1|Participant Flow|AcrySof IQ IOL|ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
33518|NCT02219997|O2|Outcome|Clear IOL + BLF|Clear IOL with clip-on glasses with blue light filtering properties
33519|NCT02219997|O1|Outcome|ACRYSOF IQ IOL + Placebo Filter|ACRYSOF® IQ IOL with clear clip-on glasses with no light filtering properties used as a placebo
33520|NCT02219997|O2|Outcome|Blue Light Filter|Clear IOL with clip-on glasses with blue light filtering properties
33521|NCT02219997|O1|Outcome|Placebo Filter|Clear IOLs with placebo colored clip-on filters
33522|NCT02219997|O2|Outcome|Clear IOL|Clear IOL without filters
33523|NCT02219997|O1|Outcome|AcrySof IQ IOL|ACRYSOF® IQ IOL without filters
33524|NCT02219997|E3|Reported Event|Clear IOL|All subjects implanted with Clear IOLs from time of initiation of experimental testing
33525|NCT02219997|E2|Reported Event|AcrySof IQ IOL|All subjects implanted with ACRYSOF® IQ IOLs from time of initiation of experimental testing
33526|NCT02219997|E1|Reported Event|Pre-treatment|All subjects from time to consent until initiation of experimental testing
33527|NCT02219932|B3|Baseline|Total|Total of all reporting groups
33528|NCT02219932|B2|Baseline|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
33529|NCT02219932|B1|Baseline|Placebo|Placebo BID for up to 24 weeks
33530|NCT02219932|P2|Participant Flow|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
33531|NCT02219932|P1|Participant Flow|Placebo|Placebo twice daily (BID) for up to 24 weeks
33532|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
33533|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
33534|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
33535|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
33536|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
33537|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
33538|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
33539|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
33540|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
33541|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
33542|NCT02219932|E2|Reported Event|Fampridine 10mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
33543|NCT02219932|E1|Reported Event|Placebo|Placebo twice daily (BID) for up to 24 weeks
33544|NCT02219685|B3|Baseline|Total|Total of all reporting groups
33545|NCT02219685|B2|Baseline|Placebo|LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
57307|NCT02033200|O2|Outcome|Placebo|placebo
33546|NCT02219685|B1|Baseline|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
33547|NCT02219685|P2|Participant Flow|Placebo, Followed by Open-Label LDV/SOF|LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
33548|NCT02219685|P1|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
33549|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33550|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33551|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33552|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33553|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33554|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33555|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33556|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33557|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33558|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33559|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33560|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33561|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33562|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33563|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33564|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33565|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33566|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33567|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33568|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33569|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33570|NCT02219685|O2|Outcome|Open-Label Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Open-Label Treatment Phase
33571|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33572|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33573|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33574|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33575|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33576|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33577|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33578|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33579|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33580|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33581|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33582|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33583|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33584|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33585|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33586|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
33587|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
33588|NCT02219685|E3|Reported Event|LDV/SOF (Open-Label Phase), Following Placebo in Blinded Phase|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Open-Label Treatment Phase
33589|NCT02219685|E2|Reported Event|Placebo (Blinded Phase)|LDV/SOF placebo tablet once daily for 12 weeks
33590|NCT02219685|E1|Reported Event|LDV/SOF (Blinded Phase)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
33591|NCT02219516|B5|Baseline|Total|Total of all reporting groups
33592|NCT02219516|B4|Baseline|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33593|NCT02219516|B3|Baseline|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33594|NCT02219516|B2|Baseline|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33595|NCT02219516|B1|Baseline|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33596|NCT02219516|P4|Participant Flow|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
36112|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
33597|NCT02219516|P3|Participant Flow|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33598|NCT02219516|P2|Participant Flow|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33599|NCT02219516|P1|Participant Flow|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33600|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33601|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33602|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33603|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33604|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33605|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33606|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33607|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33608|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33609|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33610|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33611|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33612|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33613|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33614|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33615|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33616|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33617|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33618|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33619|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33620|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33621|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33622|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33623|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33624|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33625|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33626|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33627|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33628|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33629|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33630|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33631|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33632|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33633|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33764|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
33634|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33635|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33636|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33637|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
44552|NCT02130999|E2|Reported Event|Tasimelteon 2mg IV|
33638|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33639|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33640|NCT02219516|E4|Reported Event|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
33641|NCT02219516|E3|Reported Event|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
33642|NCT02219516|E2|Reported Event|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
33643|NCT02219516|E1|Reported Event|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
33644|NCT02219503|B1|Baseline|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
33645|NCT02219503|P1|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
33646|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
33647|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
33648|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
33649|NCT02219503|E1|Reported Event|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
33650|NCT02219477|B4|Baseline|Total|Total of all reporting groups
33651|NCT02219477|B3|Baseline|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
33652|NCT02219477|B2|Baseline|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
33653|NCT02219477|B1|Baseline|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
33654|NCT02219477|P3|Participant Flow|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
33655|NCT02219477|P2|Participant Flow|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
33656|NCT02219477|P1|Participant Flow|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants
33657|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
33658|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
33659|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
33660|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
33661|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
33662|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
33663|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
33664|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
33665|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
33666|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
33667|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
33668|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
33669|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
33670|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
33671|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
33672|NCT02219477|O3|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
34663|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
33673|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
33674|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
33675|NCT02219477|O1|Outcome|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
33676|NCT02219477|O2|Outcome|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
33677|NCT02219477|O1|Outcome|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
33678|NCT02219477|E3|Reported Event|Group 3: GT4|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
33679|NCT02219477|E2|Reported Event|Group 2: GT1 Non-B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
33680|NCT02219477|E1|Reported Event|Group 1: GT1B|ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
33681|NCT02219464|B3|Baseline|Total|Total of all reporting groups
33682|NCT02219464|B2|Baseline|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.
Nasal Cannula
Oxygen Supplementation: Initially set at 4 liters/minute
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
33683|NCT02219464|B1|Baseline|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.
Nasopharyngeal catheter
Oxygen Supplementation: Initially set at 4 liters/minute
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
33684|NCT02219464|P2|Participant Flow|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.
Nasal Cannula
Oxygen Supplementation: Initially set at 4 liters/minute
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
33685|NCT02219464|P1|Participant Flow|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.
Nasopharyngeal catheter
Oxygen Supplementation: Initially set at 4 liters/minute
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
33686|NCT02219464|O2|Outcome|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.
Nasal Cannula
Oxygen Supplementation: Initially set at 4 liters/minute
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
33687|NCT02219464|O1|Outcome|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.
Nasopharyngeal catheter
Oxygen Supplementation: Initially set at 4 liters/minute
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
33688|NCT02219464|O2|Outcome|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.
Nasal Cannula
Oxygen Supplementation: Initially set at 4 liters/minute
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
33689|NCT02219464|O1|Outcome|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.
Nasopharyngeal catheter
Oxygen Supplementation: Initially set at 4 liters/minute
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
33690|NCT02219464|E2|Reported Event|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.
Nasal Cannula
Oxygen Supplementation: Initially set at 4 liters/minute
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
33691|NCT02219464|E1|Reported Event|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.
Nasopharyngeal catheter
Oxygen Supplementation: Initially set at 4 liters/minute
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
33692|NCT02219282|B3|Baseline|Total|Total of all reporting groups
33693|NCT02219282|B2|Baseline|Group Edentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
33694|NCT02219282|B1|Baseline|Group Dentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
33765|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
33766|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
33767|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
33768|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
33695|NCT02219282|P2|Participant Flow|Group Edentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
33696|NCT02219282|P1|Participant Flow|Group Dentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
33717|NCT02219256|B5|Baseline|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
33718|NCT02219256|B4|Baseline|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
44553|NCT02130999|E1|Reported Event|Tasimelteon 20mg Oral|
33697|NCT02219282|O2|Outcome|Edentulous Group|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
33698|NCT02219282|O1|Outcome|Dentilous Group|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
33699|NCT02219282|O2|Outcome|Edentuolus|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
33700|NCT02219282|O1|Outcome|Dentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience"
33701|NCT02219282|O2|Outcome|Group Edentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
33702|NCT02219282|O1|Outcome|Group Dentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
33703|NCT02219282|O2|Outcome|Group Edentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
33704|NCT02219282|O1|Outcome|Group Dentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
33705|NCT02219282|O2|Outcome|Group Edentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
33706|NCT02219282|O1|Outcome|Group Dentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
33707|NCT02219282|E2|Reported Event|Group Edentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
57308|NCT02033200|O1|Outcome|Active|Stendra 200 mg
33708|NCT02219282|E1|Reported Event|Group Dentulous|"Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience."
33709|NCT02219256|B13|Baseline|Total|Total of all reporting groups
33710|NCT02219256|B12|Baseline|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
33711|NCT02219256|B11|Baseline|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
33712|NCT02219256|B10|Baseline|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
33713|NCT02219256|B9|Baseline|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
33714|NCT02219256|B8|Baseline|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
33715|NCT02219256|B7|Baseline|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
33716|NCT02219256|B6|Baseline|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
33719|NCT02219256|B3|Baseline|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
33720|NCT02219256|B2|Baseline|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
33721|NCT02219256|B1|Baseline|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
33722|NCT02219256|P12|Participant Flow|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
33723|NCT02219256|P11|Participant Flow|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
33724|NCT02219256|P10|Participant Flow|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
33725|NCT02219256|P9|Participant Flow|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
33726|NCT02219256|P8|Participant Flow|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
33727|NCT02219256|P7|Participant Flow|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
33728|NCT02219256|P6|Participant Flow|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
33729|NCT02219256|P5|Participant Flow|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
33730|NCT02219256|P4|Participant Flow|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
33731|NCT02219256|P3|Participant Flow|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
33732|NCT02219256|P2|Participant Flow|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
33733|NCT02219256|P1|Participant Flow|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
33734|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
33735|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
33736|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
33737|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
33738|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
33739|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
33740|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
33741|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
33742|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
33743|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
33744|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
33745|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
33746|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
33747|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
33748|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
33749|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
33750|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
33751|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
33752|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
33753|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
33754|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
33755|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
33756|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
33757|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
33758|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
33759|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
33760|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
33761|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
33762|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
33763|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
33769|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
33770|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
33771|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
33772|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
33773|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
33774|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
33775|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
33776|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
33777|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
33778|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
33779|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
33780|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
33781|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
33782|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
33783|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
33784|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
33785|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
33786|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
33787|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
33788|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
33789|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
33790|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
33791|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
33792|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
33793|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
33794|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
33795|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
33796|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
33797|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
33798|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
33799|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
33800|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
33801|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
33802|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
33803|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
33804|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
33805|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
33806|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
33807|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
33808|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
33809|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
33810|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
33811|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
33812|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
33813|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
33814|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
33815|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
33816|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
33817|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
33818|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
33819|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
33820|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
33821|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
33822|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
33823|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
33824|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
33825|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
57309|NCT02033200|O2|Outcome|Placebo|placebo
33826|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
33827|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
33828|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
33829|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
33830|NCT02219256|E12|Reported Event|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
33831|NCT02219256|E11|Reported Event|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
33832|NCT02219256|E10|Reported Event|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
33833|NCT02219256|E9|Reported Event|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
33834|NCT02219256|E8|Reported Event|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
33835|NCT02219256|E7|Reported Event|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
33836|NCT02219256|E6|Reported Event|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
33837|NCT02219256|E5|Reported Event|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
33838|NCT02219256|E4|Reported Event|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
33839|NCT02219256|E3|Reported Event|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
33840|NCT02219256|E2|Reported Event|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
33841|NCT02219256|E1|Reported Event|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
33842|NCT02218697|B3|Baseline|Total|Total of all reporting groups
33843|NCT02218697|B2|Baseline|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33844|NCT02218697|B1|Baseline|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33845|NCT02218697|P2|Participant Flow|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33846|NCT02218697|P1|Participant Flow|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33847|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33848|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33849|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33850|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33851|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33852|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33853|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33854|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33855|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33856|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33857|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33858|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33859|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33860|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33861|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33862|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33863|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33864|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33865|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33866|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33867|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33868|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
34077|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
33869|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33870|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33871|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33872|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33873|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
36160|NCT02199717|P1|Participant Flow|Boys With Hemophilia|Use of accelerometer for 1 week
33874|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33875|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33876|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33877|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33878|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33879|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33880|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33881|NCT02218697|E2|Reported Event|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
33882|NCT02218697|E1|Reported Event|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
33883|NCT02218307|B3|Baseline|Total|Total of all reporting groups
33884|NCT02218307|B2|Baseline|Placebo|"Placebo control for mupirocin
Placebo"
33885|NCT02218307|B1|Baseline|Mupirocin|"topical antibiotic
Mupirocin"
33886|NCT02218307|P2|Participant Flow|Placebo|"Placebo control for mupirocin
Placebo"
33887|NCT02218307|P1|Participant Flow|Mupirocin|"topical antibiotic
Mupirocin"
33888|NCT02218307|O2|Outcome|Placebo|"Placebo control for mupirocin
Placebo"
33889|NCT02218307|O1|Outcome|Mupirocin|"topical antibiotic
Mupirocin"
33890|NCT02218307|O2|Outcome|Placebo|"Placebo control for mupirocin
Placebo"
33891|NCT02218307|O1|Outcome|Mupirocin|"topical antibiotic
Mupirocin"
33892|NCT02218307|E2|Reported Event|Placebo|"Placebo control for mupirocin
Placebo"
33893|NCT02218307|E1|Reported Event|Mupirocin|"topical antibiotic
Mupirocin"
33894|NCT02218268|B1|Baseline|All Participants|This is a crossover study of youth with Diabetes on a stable basal bolus insulin regimen. They will be randomized either receive a pre-meal insulin bolus in conjunction with their Basal insulin bolus or receive their standard of care basal insulin bolus only. A mixed meal replacement (Boost) will be consumed. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.
33895|NCT02218268|P2|Participant Flow|No Meal Bolus Then Pre-meal Bolus|"A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.
Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
33896|NCT02218268|P1|Participant Flow|Pre-meal Bolus Then No Meal Bolus|"A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.
Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
33897|NCT02218268|O2|Outcome|No Meal Bolus Then Pre-meal Bolus|"A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.
Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
33947|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
34078|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
33898|NCT02218268|O1|Outcome|Pre-meal Bolus Then No Meal Bolus|"A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.
Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
33899|NCT02218268|E2|Reported Event|No Meal Bolus Then Pre-meal Bolus|A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring, This is a crossover study and all participants will take place in this arm after 3 months of their visit.
33900|NCT02218268|E1|Reported Event|Pre-meal Bolus Then No Meal Bolus|A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.
33901|NCT02218216|B3|Baseline|Total|Total of all reporting groups
33902|NCT02218216|B2|Baseline|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
33903|NCT02218216|B1|Baseline|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
33904|NCT02218216|P3|Participant Flow|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
33905|NCT02218216|P2|Participant Flow|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
33906|NCT02218216|P1|Participant Flow|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
33907|NCT02218216|O3|Outcome|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
33908|NCT02218216|O2|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
33909|NCT02218216|O1|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
33910|NCT02218216|E3|Reported Event|Volunteer Controls|"Non injured volunteers for device calibration
Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
33911|NCT02218216|E2|Reported Event|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
33912|NCT02218216|E1|Reported Event|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
33913|NCT02217982|B3|Baseline|Total|Total of all reporting groups
33914|NCT02217982|B2|Baseline|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.
Simethicone
Loperamide
Peanut Butter"
33915|NCT02217982|B1|Baseline|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
33916|NCT02217982|P2|Participant Flow|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.
Simethicone
Loperamide
Peanut Butter"
33948|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33949|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33917|NCT02217982|P1|Participant Flow|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
33918|NCT02217982|O2|Outcome|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.
Simethicone
Loperamide
Peanut Butter"
33919|NCT02217982|O1|Outcome|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
33920|NCT02217982|O2|Outcome|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.
Simethicone
Loperamide
Peanut Butter"
44554|NCT02130635|B10|Baseline|Total|Total of all reporting groups
33921|NCT02217982|O1|Outcome|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
33922|NCT02217982|E2|Reported Event|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.
Simethicone
Loperamide
Peanut Butter"
33923|NCT02217982|E1|Reported Event|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
33924|NCT02217878|B3|Baseline|Total|Total of all reporting groups
33925|NCT02217878|B2|Baseline|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33926|NCT02217878|B1|Baseline|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33927|NCT02217878|P2|Participant Flow|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33928|NCT02217878|P1|Participant Flow|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33929|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33930|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33931|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33932|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33933|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33934|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33935|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33936|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33937|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33938|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33939|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33940|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33941|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33942|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33943|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33944|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33945|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33946|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
34131|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
33950|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33951|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33952|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33953|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33954|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33955|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33956|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33957|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33958|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33959|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33960|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33961|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33962|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33963|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33964|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33965|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33966|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33967|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33968|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33969|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33970|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33971|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33972|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33973|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33974|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33975|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33976|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33977|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33978|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33979|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33980|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33981|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33982|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33983|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33984|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33985|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33986|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33987|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33988|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33989|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33990|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33991|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33992|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33993|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33994|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33995|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33996|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33997|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
33998|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
33999|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
34000|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
34001|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
34002|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
34003|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
34004|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
34005|NCT02217878|E2|Reported Event|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Placebo: IV bolus injection
Ticagrelor: 180 mg loading dose"
34006|NCT02217878|E1|Reported Event|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor
Morphine: IV bolus injection
Ticagrelor: 180 mg loading dose"
34007|NCT02217280|B1|Baseline|Cervical ESI With Gadolinium|Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
34008|NCT02217280|P1|Participant Flow|Cervical ESI With Gadolinium|Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
34009|NCT02217280|O1|Outcome|Cervical ESI|Male and female subjects between the ages of 18-85 with cervical radiculopathy. This was a single arm study.
34010|NCT02217280|O1|Outcome|Injection With Gadolinium|"This group of patients identified by the PI as having cervical radiculopathy will receive gadolinium (the intervention) in their epidural cervical injection along with steroid (DepoMedrol). There is no control group in this study.
Injection with Gadolinium: Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system"
34011|NCT02217280|E1|Reported Event|Cervical ESI With Gadolinium|Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
34012|NCT02216695|B1|Baseline|Acute Kidney Injury|we analysed acute kidney injury requiring dialysis in England
34013|NCT02216695|P1|Participant Flow|Acute Kidney Injury|All patients who had acute kidney injury requiring dialysis between 1998 and 2013 were identified from hospital episode statistic
34014|NCT02216695|O1|Outcome|Acute Kidney Injury Requiring Dialysis|The associations between discharge status was tested with multivariable regression model which included age group and discharge period,
34015|NCT02216695|O1|Outcome|Acute Kidney Injury Requiring Dialysis|Age was categorized into the groups 65, 65–74, 75–84, and > 85. The associations between discharge status was tested with multivariable regression model which included gender, age group, discharge period, admission method, CCS, ethnicity, and AKI in diagnoses code.
34016|NCT02216695|O1|Outcome|Acute Kidney Injury|All patients who had acute kidney injury requiring dialysis between 1998 and 2013 were identified from hospital episode statistic
34017|NCT02216695|O3|Outcome|2008-13|Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
34018|NCT02216695|O2|Outcome|2003-08|Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
34019|NCT02216695|O1|Outcome|1998-03|All patients who had acute kidney injury and required dialysis between 1998 and 2013 were identified from hospital episode statistic.Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
34020|NCT02216695|E1|Reported Event|Dialysis Requiring AKI|AKI patients who required renal replacement therapy
34021|NCT02216591|B3|Baseline|Total|Total of all reporting groups
34075|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
34022|NCT02216591|B2|Baseline|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.
Control (CON)"
34023|NCT02216591|B1|Baseline|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.
Active Cognitive Training (ACT)"
34043|NCT02216357|P2|Participant Flow|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34085|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
34024|NCT02216591|P2|Participant Flow|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.
Control (CON)"
34025|NCT02216591|P1|Participant Flow|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.
Active Cognitive Training (ACT)"
34026|NCT02216591|O2|Outcome|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.
Control (CON)"
34027|NCT02216591|O1|Outcome|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.
Active Cognitive Training (ACT)"
34028|NCT02216591|O2|Outcome|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.
Control (CON)"
34029|NCT02216591|O1|Outcome|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.
Active Cognitive Training (ACT)"
34030|NCT02216591|O2|Outcome|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.
Control (CON)"
34031|NCT02216591|O1|Outcome|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.
Active Cognitive Training (ACT)"
34032|NCT02216591|E2|Reported Event|Control (CON)|"The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.
Control (CON)"
34033|NCT02216591|E1|Reported Event|Active Cognitive Training (ACT)|"The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.
Active Cognitive Training (ACT)"
34034|NCT02216422|B1|Baseline|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
34035|NCT02216422|P1|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
34076|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
34036|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
34037|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
34038|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
34039|NCT02216422|E1|Reported Event|Ombitasvir/Paritaprevir/Ritonavir Plus|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
34040|NCT02216357|B3|Baseline|Total|Total of all reporting groups
34041|NCT02216357|B2|Baseline|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34042|NCT02216357|B1|Baseline|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34044|NCT02216357|P1|Participant Flow|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34045|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34046|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34047|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34048|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34049|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34050|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34051|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34052|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34053|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34054|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34055|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34056|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34057|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34058|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34059|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34060|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34061|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34062|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34063|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34064|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34065|NCT02216357|E2|Reported Event|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule"
34066|NCT02216357|E1|Reported Event|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule"
34067|NCT02216097|B3|Baseline|Total|Total of all reporting groups
34068|NCT02216097|B2|Baseline|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
34069|NCT02216097|B1|Baseline|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
34070|NCT02216097|P2|Participant Flow|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
34071|NCT02216097|P1|Participant Flow|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
34072|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
34073|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
34074|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
34079|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
34080|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
34081|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
34082|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
34083|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
34084|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
46364|NCT02117570|B4|Baseline|Total|Total of all reporting groups
34086|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
34087|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
34088|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
34089|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
34090|NCT02216097|E2|Reported Event|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
34091|NCT02216097|E1|Reported Event|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
34092|NCT02215954|B4|Baseline|Total|Total of all reporting groups
34093|NCT02215954|B3|Baseline|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy
Niflec"
34094|NCT02215954|B2|Baseline|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy
FE 999169"
34095|NCT02215954|B1|Baseline|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169"
34096|NCT02215954|P3|Participant Flow|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy
Niflec"
34097|NCT02215954|P2|Participant Flow|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy
FE 999169"
34098|NCT02215954|P1|Participant Flow|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169"
34099|NCT02215954|O3|Outcome|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy
Niflec"
34100|NCT02215954|O2|Outcome|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy
FE 999169"
34101|NCT02215954|O1|Outcome|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169"
34102|NCT02215954|O3|Outcome|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy
Niflec"
34103|NCT02215954|O2|Outcome|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy
FE 999169"
34104|NCT02215954|O1|Outcome|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169"
34105|NCT02215954|O3|Outcome|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy
Niflec"
34106|NCT02215954|O2|Outcome|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy
FE 999169"
34107|NCT02215954|O1|Outcome|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169"
34108|NCT02215954|O3|Outcome|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy
Niflec"
34109|NCT02215954|O2|Outcome|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy
FE 999169"
34110|NCT02215954|O1|Outcome|Treatment Arm [1]: FE 999169|"One sachet of the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169"
34111|NCT02215954|O3|Outcome|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy
Niflec"
34112|NCT02215954|O2|Outcome|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy
FE 999169"
34113|NCT02215954|O1|Outcome|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169"
34114|NCT02215954|E3|Reported Event|Treatment Arm [3]: Niflec|"One to two pack(s) on the day of colonoscopy
Niflec"
34115|NCT02215954|E2|Reported Event|Treatment Arm [2]: FE 999169|"Two sachets on the day before colonoscopy
FE 999169"
34116|NCT02215954|E1|Reported Event|Treatment Arm [1]: FE 999169|"One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169"
34117|NCT02215252|B4|Baseline|Total|Total of all reporting groups
34118|NCT02215252|B3|Baseline|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34119|NCT02215252|B2|Baseline|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34120|NCT02215252|B1|Baseline|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34121|NCT02215252|P3|Participant Flow|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34122|NCT02215252|P2|Participant Flow|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34123|NCT02215252|P1|Participant Flow|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34124|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34125|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34126|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34127|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34128|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34129|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34130|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34132|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34133|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34134|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34135|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34136|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34137|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34138|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34139|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34140|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34141|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34142|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34143|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34144|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34145|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34146|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34147|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34148|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34149|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34150|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34151|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34152|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34153|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34154|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34155|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34156|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34157|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34158|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34159|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34160|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34161|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34162|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34163|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34164|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34165|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34166|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34167|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34168|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34169|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34170|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34171|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34172|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34173|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34174|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34175|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34176|NCT02215252|E3|Reported Event|Placebo|Participants received matched placebo oral capsule for 4 weeks.
34177|NCT02215252|E2|Reported Event|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
34178|NCT02215252|E1|Reported Event|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
34179|NCT02214615|B3|Baseline|Total|Total of all reporting groups
34207|NCT02214225|P3|Participant Flow|Trivalent Influenza Vaccine (TIV-2)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
34470|NCT02212301|E2|Reported Event|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.
34180|NCT02214615|B2|Baseline|Placebo the Carbamazepine|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.
Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
34211|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
36161|NCT02199717|O2|Outcome|Mild/Moderate Hemophilia|Mild/Moderate Hemophilia
34181|NCT02214615|B1|Baseline|Carbamazepine Then Placebo|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.
Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.
Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
34182|NCT02214615|P2|Participant Flow|Placebo Then Carbamazepine|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.
Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
34183|NCT02214615|P1|Participant Flow|Carbamazepine Then Placebo|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.
Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.
Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
34184|NCT02214615|O2|Outcome|Placebo Then Carbamazepine|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.
Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
34185|NCT02214615|O1|Outcome|Carbamazepine Then Placebo|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.
Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.
Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
34186|NCT02214615|O2|Outcome|Placebo Then Carbamazepine|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.
Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
34247|NCT02214225|O1|Outcome|SCR: bioCSL QIV|"For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.
bioCSL QIV, Adults 18 years and older, n=1691. bioCSL QIV, Adults 18 years to <65 years, n=835. bioCSL QIV, Adults 65 years and older, n=856."
57310|NCT02033200|O1|Outcome|Active|Stendra 200 mg
34187|NCT02214615|O1|Outcome|Carbamazepine Then Placebo|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.
Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.
Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
34212|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
34213|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
34188|NCT02214615|E2|Reported Event|Placebo|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.
Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
34189|NCT02214615|E1|Reported Event|Carbamazepine|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.
Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.
Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
34190|NCT02214238|B3|Baseline|Total|Total of all reporting groups
34191|NCT02214238|B2|Baseline|Modified PAP Device First, Then Market Released PAP Device|Us of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
34192|NCT02214238|B1|Baseline|Market Released PAP Device First, Then Modified PAP Device|Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
34193|NCT02214238|P2|Participant Flow|Modified PAP Device First, Then Market Released PAP Device|Use of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
34194|NCT02214238|P1|Participant Flow|Market Released PAP Device First, Then Modified PAP Device|Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
34195|NCT02214238|O2|Outcome|Modified PAP Device|"Use of the modified PAP device
PAP device"
34196|NCT02214238|O1|Outcome|Market Released PAP Device|"Use of a market released PAP device
PAP device"
34197|NCT02214238|O2|Outcome|Modified PAP Device|"Use of the modified PAP device
PAP device"
34198|NCT02214238|O1|Outcome|Market Released PAP Device|"Use of a market released PAP device
PAP device"
34199|NCT02214238|O2|Outcome|Modified PAP Device|"Use of the modified PAP device
PAP device"
34200|NCT02214238|O1|Outcome|Market Released PAP Device|"Use of a market released PAP device
PAP device"
34201|NCT02214238|E2|Reported Event|Market Released PAP Device|Use of a market released PAP device for 3 more weeks.
34202|NCT02214238|E1|Reported Event|Modified PAP Device|Use of a modified PAP device for 3 more weeks.
34203|NCT02214225|B4|Baseline|Total|Total of all reporting groups
34204|NCT02214225|B3|Baseline|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).
TIV-2 dose: One 0.5 mL intramuscular dose into the deltoid muscle."
34205|NCT02214225|B2|Baseline|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
TIV-1 dose: One 0.5 mL intramuscular dose into the deltoid muscle."
34206|NCT02214225|B1|Baseline|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
QIV dose: One 0.5 mL intramuscular dose into the deltoid muscle."
34303|NCT02213900|E2|Reported Event|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.
Placebo"
34208|NCT02214225|P2|Participant Flow|Trivalent Influenza Vaccine (TIV-1)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
34209|NCT02214225|P1|Participant Flow|Quadrivalent Influenza Vaccine (QIV)|"The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
34210|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
34310|NCT02213510|B2|Baseline|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34214|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
34215|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
34216|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
34217|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
34218|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
34219|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
34220|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
34221|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
34222|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
34223|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
34224|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
34225|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
34226|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
34227|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
34228|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
34229|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
34230|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
34231|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
34232|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
34233|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
34234|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
34235|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
34236|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
34237|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
34238|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
34239|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
34240|NCT02214225|O6|Outcome|bioCSL TIV-2 (B/VIC) (≥ 65 Years)|
34241|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
34242|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
34243|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
34244|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
34245|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
34246|NCT02214225|O2|Outcome|SCR: Pooled TIV-1 or TIV-2|"For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.
B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854. B/Yamagata serology for TIV-2 (B Victoria), Adults 18 to <65 years, n=421. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years to <65 years, n=424.
B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429. B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430."
34664|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34248|NCT02214225|O2|Outcome|Postvaccination GMT: TIV-1 (B/YAM) or TIV-2 (B/VIC)|B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854 B/Yamagata serology for TIV-2 (B Victoria), Adults 18 through 64 years inclusive, n=421 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 through 64 years inclusive, n=424 B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429 B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430.
34249|NCT02214225|O1|Outcome|Postvaccination GMT: bioCSL QIV|bioCSL QIV, Adults 18 years and older, N=1691. 18 to < 65 years, n=835. => 65 years, n=856.
34250|NCT02214225|O4|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.
bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
34251|NCT02214225|O3|Outcome|SCR: bioCSL QIV (≥ 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.
bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
34252|NCT02214225|O2|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to <65years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.
bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
34253|NCT02214225|O1|Outcome|SCR: bioCSL QIV (18 to < 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.
bioCSL QIV, n=835. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421."
34254|NCT02214225|O4|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)|Postvaccination GMT. Pooled TIV (A strains), n=859 TIV-1 (B/YAM), n=430. TIV-2 (B/VIC), n=429.
34255|NCT02214225|O3|Outcome|GMT: bioCSL QIV (≥ 65 Years)|Postvaccination GMT. bioCSL QIV, n=856.
34256|NCT02214225|O2|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to <65years)|Postvaccination GMT. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421.
34257|NCT02214225|O1|Outcome|GMT: bioCSL QIV (18 to <65 Years)|Postvaccination GMT. bioCSL QIV, n=835.
34258|NCT02214225|O2|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)|Pooled TIV (A strains), n=1704. TIV-1 (B Yamagata), n=854. TIV-2 (B Victoria), n=850.
34259|NCT02214225|O1|Outcome|SCR: bioCSL QIV|bioCSL QIV, n=1691.
34260|NCT02214225|O2|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)|"Postvaccination GMT.
Pooled TIV (A strains), N=1704. TIV-1 (B/YAM), N=854. TIV-2 (B/VIC), N=850."
34261|NCT02214225|O1|Outcome|GMT: bioCSL QIV|Postvaccination GMT.
34262|NCT02214225|E3|Reported Event|Trivalent Influenza Vaccine (TIV-2)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
34263|NCT02214225|E2|Reported Event|Trivalent Influenza Vaccine (TIV-1)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
34264|NCT02214225|E1|Reported Event|Quadrivalent Influenza Vaccine (QIV)|"The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
34265|NCT02214186|B3|Baseline|Total|Total of all reporting groups
34266|NCT02214186|B2|Baseline|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34267|NCT02214186|B1|Baseline|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34268|NCT02214186|P2|Participant Flow|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34269|NCT02214186|P1|Participant Flow|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34270|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34271|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34272|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34273|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34274|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34471|NCT02212301|E1|Reported Event|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
34275|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34276|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34277|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34278|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34279|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34280|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34281|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34282|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34283|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34284|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34285|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34286|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34287|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34288|NCT02214186|E2|Reported Event|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
34289|NCT02214186|E1|Reported Event|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
34290|NCT02213900|B3|Baseline|Total|Total of all reporting groups
34291|NCT02213900|B2|Baseline|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.
Placebo"
34292|NCT02213900|B1|Baseline|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.
Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
34293|NCT02213900|P2|Participant Flow|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.
Placebo"
34294|NCT02213900|P1|Participant Flow|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.
Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
34295|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.
Placebo"
34296|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.
Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
34297|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.
Placebo"
34298|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.
Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
34299|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.
Placebo"
34300|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.
Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
34301|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.
Placebo"
34302|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.
Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
34304|NCT02213900|E1|Reported Event|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.
Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
34305|NCT02213666|B1|Baseline|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
34306|NCT02213666|P1|Participant Flow|Intracardiac and Transesophageal Echocardiography|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
34307|NCT02213666|O1|Outcome|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
34308|NCT02213666|E1|Reported Event|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
34309|NCT02213510|B3|Baseline|Total|Total of all reporting groups
34406|NCT02212834|B2|Baseline|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
34311|NCT02213510|B1|Baseline|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34312|NCT02213510|P2|Participant Flow|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34313|NCT02213510|P1|Participant Flow|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34314|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34315|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34316|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34317|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34318|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34319|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34320|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34321|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34322|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34472|NCT02212197|B4|Baseline|Total|Total of all reporting groups
57311|NCT02033200|O2|Outcome|Placebo|placebo
34323|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34324|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34341|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34342|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
36162|NCT02199717|O1|Outcome|Severe Hemophilia|Severe Hemophilia
34325|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34326|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34327|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34328|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34329|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34330|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34331|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34332|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34333|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34334|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34335|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34336|NCT02213510|E2|Reported Event|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
34337|NCT02213510|E1|Reported Event|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
34338|NCT02213250|B1|Baseline|All Participants|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34339|NCT02213250|P2|Participant Flow|BeneFIX 50 IU/kg; Age Group: >=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34340|NCT02213250|P1|Participant Flow|BeneFIX 50 IU/kg; Age Group: >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by intravenous (IV) infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
47647|NCT02106728|B3|Baseline|Total|Total of all reporting groups
34343|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34344|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34345|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34346|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34347|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34348|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34349|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34350|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34351|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34352|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34353|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34354|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34355|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34356|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34357|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34358|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34359|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34360|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34361|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34362|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; Age Group>=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34363|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34364|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34365|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34366|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34367|NCT02213250|E1|Reported Event|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
34368|NCT02213198|B3|Baseline|Total|Total of all reporting groups
34473|NCT02212197|B3|Baseline|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
34369|NCT02213198|B2|Baseline|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.
Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
34370|NCT02213198|B1|Baseline|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention
Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
34371|NCT02213198|P2|Participant Flow|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.
Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
34372|NCT02213198|P1|Participant Flow|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention
Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
34373|NCT02213198|O2|Outcome|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.
Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
34374|NCT02213198|O1|Outcome|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention
Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
34375|NCT02213198|O2|Outcome|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.
Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
34376|NCT02213198|O1|Outcome|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention
Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
34377|NCT02213198|E2|Reported Event|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.
Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
34378|NCT02213198|E1|Reported Event|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention
Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
34379|NCT02213055|B3|Baseline|Total|Total of all reporting groups
34380|NCT02213055|B2|Baseline|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.
Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application."
34392|NCT02212977|P1|Participant Flow|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
34393|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
34394|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
34381|NCT02213055|B1|Baseline|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.
LiceMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
34382|NCT02213055|P2|Participant Flow|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.
Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application."
34402|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
34403|NCT02212977|E2|Reported Event|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
34404|NCT02212977|E1|Reported Event|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
34383|NCT02213055|P1|Participant Flow|LICEMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.
LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
34384|NCT02213055|O2|Outcome|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.
Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application."
34385|NCT02213055|O1|Outcome|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.
LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
34386|NCT02213055|E2|Reported Event|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.
Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application."
34387|NCT02213055|E1|Reported Event|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.
LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
34388|NCT02212977|B3|Baseline|Total|Total of all reporting groups
34389|NCT02212977|B2|Baseline|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
34390|NCT02212977|B1|Baseline|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
34391|NCT02212977|P2|Participant Flow|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
34529|NCT02212028|E1|Reported Event|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
34395|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
34396|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
34397|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
34398|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
34399|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
34400|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
34401|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
34405|NCT02212834|B3|Baseline|Total|Total of all reporting groups
47954|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
34407|NCT02212834|B1|Baseline|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
34408|NCT02212834|P2|Participant Flow|Breast MRI|Surveillance Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
34409|NCT02212834|P1|Participant Flow|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
34410|NCT02212834|O2|Outcome|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
34411|NCT02212834|O1|Outcome|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
34412|NCT02212834|E2|Reported Event|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
34413|NCT02212834|E1|Reported Event|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
34414|NCT02212457|B7|Baseline|Total|Total of all reporting groups
34415|NCT02212457|B6|Baseline|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
34416|NCT02212457|B5|Baseline|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
34417|NCT02212457|B4|Baseline|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
34418|NCT02212457|B3|Baseline|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
34419|NCT02212457|B2|Baseline|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34420|NCT02212457|B1|Baseline|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34421|NCT02212457|P6|Participant Flow|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
34422|NCT02212457|P5|Participant Flow|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
34423|NCT02212457|P4|Participant Flow|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
34424|NCT02212457|P3|Participant Flow|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
34425|NCT02212457|P2|Participant Flow|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34426|NCT02212457|P1|Participant Flow|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34427|NCT02212457|O6|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
34428|NCT02212457|O5|Outcome|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
34429|NCT02212457|O4|Outcome|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
34430|NCT02212457|O3|Outcome|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
34431|NCT02212457|O2|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34432|NCT02212457|O1|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34433|NCT02212457|O6|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
34434|NCT02212457|O5|Outcome|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
34469|NCT02212301|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
34435|NCT02212457|O4|Outcome|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
34436|NCT02212457|O3|Outcome|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
34437|NCT02212457|O2|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34438|NCT02212457|O1|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34439|NCT02212457|O6|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
34440|NCT02212457|O5|Outcome|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
34441|NCT02212457|O4|Outcome|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
34442|NCT02212457|O3|Outcome|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
34539|NCT02210195|O2|Outcome|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
34443|NCT02212457|O2|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34444|NCT02212457|O1|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34445|NCT02212457|O6|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
34446|NCT02212457|O5|Outcome|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
34447|NCT02212457|O4|Outcome|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
34448|NCT02212457|O3|Outcome|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
34449|NCT02212457|O2|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34450|NCT02212457|O1|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34451|NCT02212457|O2|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
34452|NCT02212457|O1|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34453|NCT02212457|O2|Outcome|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
34454|NCT02212457|O1|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34455|NCT02212457|O2|Outcome|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34456|NCT02212457|O1|Outcome|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34457|NCT02212457|E6|Reported Event|ABCWY_0_2_6 Group|Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix® vaccine at Visit Month 1 and Visit Month 12.
34458|NCT02212457|E5|Reported Event|ABCWY_0_11 Group|Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix® vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
34459|NCT02212457|E4|Reported Event|ABCWY_0_6 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix® vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
34460|NCT02212457|E3|Reported Event|ABCWY_0_1 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix® vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
34461|NCT02212457|E2|Reported Event|ABCWY_ 0_2 Group|Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34462|NCT02212457|E1|Reported Event|rMenB_0_2 Group|Subjects received two injections of Bexsero™ vaccine at Visit Month 0 and Visit Month 2, Havrix® vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
34463|NCT02212301|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one lens throughout the duration of the study.
34464|NCT02212301|P2|Participant Flow|Lotrafilcon B / Senofilcon A|Subjects that received the lotrafilcon B contact lens in the first period and then received the senofilcon A contact lens in the second period.
34465|NCT02212301|P1|Participant Flow|Senofilcon A/ Lotrafilcon B|Subjects that received the senofilcon A contact lens in the first period and then received the lotrafilcon B contact lens in the second period.
34466|NCT02212301|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.
34467|NCT02212301|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
34468|NCT02212301|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B in either the first or second period of the study.
34474|NCT02212197|B2|Baseline|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
34475|NCT02212197|B1|Baseline|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
34476|NCT02212197|P3|Participant Flow|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
34477|NCT02212197|P2|Participant Flow|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
34478|NCT02212197|P1|Participant Flow|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
34479|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
34540|NCT02210195|O1|Outcome|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
34480|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
34481|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
34482|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
34483|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
34484|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
34485|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
34486|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
34487|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
34488|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
34489|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
34490|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
34491|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
34492|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
34493|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
34494|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
34495|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
34496|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
34497|NCT02212197|E3|Reported Event|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.
34498|NCT02212197|E2|Reported Event|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.
34499|NCT02212197|E1|Reported Event|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.
34500|NCT02212106|B3|Baseline|Total|Total of all reporting groups
34501|NCT02212106|B2|Baseline|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34502|NCT02212106|B1|Baseline|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34503|NCT02212106|P2|Participant Flow|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34504|NCT02212106|P1|Participant Flow|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34505|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34611|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
34665|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34506|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34507|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34508|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
36163|NCT02199717|O2|Outcome|Mild/Moderate Hemophilia|Mild/Moderate Hemophilia
34509|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34510|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34511|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34512|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34513|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34514|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34515|NCT02212106|O1|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34516|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34517|NCT02212106|E2|Reported Event|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34518|NCT02212106|E1|Reported Event|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
34519|NCT02212028|B3|Baseline|Total|Total of all reporting groups
34520|NCT02212028|B2|Baseline|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
34521|NCT02212028|B1|Baseline|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
34522|NCT02212028|P2|Participant Flow|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
34523|NCT02212028|P1|Participant Flow|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
34524|NCT02212028|O2|Outcome|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
34525|NCT02212028|O1|Outcome|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
34526|NCT02212028|O2|Outcome|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
34527|NCT02212028|O1|Outcome|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
34528|NCT02212028|E2|Reported Event|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
34530|NCT02210208|B1|Baseline|All Participants|"All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a Donor site to help the burn wound heal. The Donor site was also treated and these patients were included i part B."
34531|NCT02210208|P1|Participant Flow|Mepitel Ag|"Mepitel Ag treatment
Mepitel Ag"
34532|NCT02210208|O1|Outcome|Mepitel Ag|"Mepitel Ag treatment on burn wound
Mepitel Ag"
34533|NCT02210208|E1|Reported Event|Mepitel Ag|"Mepitel Ag treatment
Mepitel Ag"
34534|NCT02210195|B3|Baseline|Total|Total of all reporting groups
34535|NCT02210195|B2|Baseline|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
34536|NCT02210195|B1|Baseline|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
34537|NCT02210195|P2|Participant Flow|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
34538|NCT02210195|P1|Participant Flow|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
36164|NCT02199717|O1|Outcome|Severe Hemophilia|Severe Hemophilia
34541|NCT02210195|O2|Outcome|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
34542|NCT02210195|O1|Outcome|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
34543|NCT02210195|E2|Reported Event|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
34544|NCT02210195|E1|Reported Event|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
34545|NCT02210091|B3|Baseline|Total|Total of all reporting groups
34546|NCT02210091|B2|Baseline|6 to <12 Years Old|
34547|NCT02210091|B1|Baseline|<6 Years Old|
34548|NCT02210091|P2|Participant Flow|6 to <12 Years Old|
34549|NCT02210091|P1|Participant Flow|<6 Years Old|
34550|NCT02210091|O1|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34551|NCT02210091|O3|Outcome|Full Analysis Set|
34552|NCT02210091|O2|Outcome|6 to <12 Years Old|
34553|NCT02210091|O1|Outcome|<6 Years Old|
34554|NCT02210091|O3|Outcome|Full Analysis Set|
34555|NCT02210091|O2|Outcome|6 to <12 Years Old|
34556|NCT02210091|O1|Outcome|<6 Years Old|
34557|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34558|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34559|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34560|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34561|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34562|NCT02210091|O1|Outcome|PK Analysis Set <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34563|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34564|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34565|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34566|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34567|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34662|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34568|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34569|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34570|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34571|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34572|NCT02210091|O1|Outcome|Overall Study Arm|
34674|NCT02209766|E4|Reported Event|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
34573|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34574|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years olde who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34575|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
34576|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34577|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34578|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
34579|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34580|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34581|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
34582|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34583|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34584|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
34585|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34586|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34587|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
34588|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34589|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34590|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
34591|NCT02210091|O3|Outcome|Full Analysis Set|Participants who received at least one dose of BAX 855.
34592|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34593|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
34594|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34595|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34596|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
34597|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34598|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34599|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
34600|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34601|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34602|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
34603|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34604|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34605|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
34606|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34607|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34608|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
34609|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34610|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34612|NCT02210091|O3|Outcome|Full Analysis Set|Participants who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
34613|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
34614|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
34615|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
34616|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
34617|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
34618|NCT02210091|E2|Reported Event|ADVATE Received Before BAX 855|Participants who received at least 1 dose of ADVATE prior to receiving BAX 855 in the PK part of the study.
34619|NCT02210091|E1|Reported Event|BAX 855 Safety Analysis Set|Participants who received at least 1 dose of BAX 855.
34675|NCT02209766|E3|Reported Event|4 g D4884 Caucasian|
34676|NCT02209766|E2|Reported Event|4 g D4884 Japanese|
34677|NCT02209766|E1|Reported Event|2 g D4884 Japanese|
34620|NCT02210052|B1|Baseline|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
34621|NCT02210052|P1|Participant Flow|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
34622|NCT02210052|O1|Outcome|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
34623|NCT02210052|E1|Reported Event|Radiofrequency Neurotomy Subjects|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
34624|NCT02209766|B5|Baseline|Total|Total of all reporting groups
34625|NCT02209766|B4|Baseline|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
34626|NCT02209766|B3|Baseline|4 g D5884 Caucasian|Single dose followed by once daily for 14 consecutive days
34627|NCT02209766|B2|Baseline|4 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34628|NCT02209766|B1|Baseline|2 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34629|NCT02209766|P5|Participant Flow|4g D5884 Caucasian|Single dose followed by once daily for 14 consecutive days
34630|NCT02209766|P4|Participant Flow|4g D5844 Japanese Placebo|Single dose followed by once daily for 14 consecutive days
34631|NCT02209766|P3|Participant Flow|4 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34632|NCT02209766|P2|Participant Flow|2 g D5884 Japanese Placebo|Single dose followed by once daily for 14 consecutive days
34633|NCT02209766|P1|Participant Flow|2 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34634|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34635|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34636|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34637|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34638|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34639|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34640|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34641|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34642|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34643|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34644|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34645|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34646|NCT02209766|O4|Outcome|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
34647|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34648|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34649|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34650|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34651|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34652|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34653|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34654|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34655|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34656|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34657|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34658|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34659|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34660|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34661|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34666|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34667|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34668|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34669|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34670|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34671|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
34672|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34673|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
34678|NCT02209506|B6|Baseline|Total|Total of all reporting groups
34679|NCT02209506|B5|Baseline|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34680|NCT02209506|B4|Baseline|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34681|NCT02209506|B3|Baseline|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34682|NCT02209506|B2|Baseline|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34683|NCT02209506|B1|Baseline|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34684|NCT02209506|P5|Participant Flow|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34685|NCT02209506|P4|Participant Flow|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34686|NCT02209506|P3|Participant Flow|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34687|NCT02209506|P2|Participant Flow|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34688|NCT02209506|P1|Participant Flow|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34689|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34690|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34691|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34692|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34693|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34694|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34695|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34696|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34697|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34698|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34699|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
57312|NCT02033200|O1|Outcome|Active|Stendra 200 mg
34700|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34701|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34702|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34794|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
36165|NCT02199717|E1|Reported Event|Severe Hemophilia|
34703|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34704|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34705|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34706|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34707|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34708|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34709|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34710|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34711|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34712|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34713|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34714|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34715|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34716|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34717|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34718|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34719|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34720|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34721|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34722|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34723|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
57313|NCT02033200|O2|Outcome|Placebo|placebo
34724|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34725|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34726|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34727|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34728|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34729|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34730|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34731|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34732|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34733|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34734|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34735|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34736|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34737|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34738|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34739|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34740|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34741|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34742|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34743|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34744|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34745|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34746|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34747|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34748|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34749|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34750|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34751|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34752|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34753|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34754|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34755|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34756|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34757|NCT02209506|E5|Reported Event|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34758|NCT02209506|E4|Reported Event|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34759|NCT02209506|E3|Reported Event|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34760|NCT02209506|E2|Reported Event|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34761|NCT02209506|E1|Reported Event|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
34762|NCT02209454|B1|Baseline|Entire Study Population|Includes groups randomized to receive 25mg DKP.TRIS tablet first and 25mg DKP.TRIS oral solution first.
34763|NCT02209454|P2|Participant Flow|Test IMP First, Then Reference IMP|25mg DKP.TRIS oral solution one single administration in first period and 25mg DKP.TRIS tablet one single administration in second period (after washout period).
34764|NCT02209454|P1|Participant Flow|Reference IMP First, Then Test IMP|25mg DKP.TRIS tablet one single administration in first period and 25mg DKP.TRIS oral solution one single administration in second period (after washout period).
34765|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet"
34766|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution"
34767|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet"
34768|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution"
34769|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet"
34770|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution"
34771|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet"
34772|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution"
34773|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet"
34774|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution"
34775|NCT02209454|E2|Reported Event|Keral® Tablet|"25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet"
34776|NCT02209454|E1|Reported Event|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution"
34777|NCT02209181|B5|Baseline|Total|Total of all reporting groups
34778|NCT02209181|B4|Baseline|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34779|NCT02209181|B3|Baseline|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34780|NCT02209181|B2|Baseline|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34781|NCT02209181|B1|Baseline|Placebo|Three placebo capsules taken orally
34782|NCT02209181|P4|Participant Flow|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34783|NCT02209181|P3|Participant Flow|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34784|NCT02209181|P2|Participant Flow|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34785|NCT02209181|P1|Participant Flow|Placebo|Three placebo capsules taken orally
34786|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34787|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34788|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34789|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34790|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34791|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34792|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34793|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
37315|NCT02190604|E17|Reported Event|Part 3 QBW251 150mg BID C1|Part 3 QBW251 150mg BID C1
34795|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34796|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34797|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34798|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34799|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34800|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34801|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34802|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34803|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34804|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34805|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34806|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34807|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34808|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34809|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34810|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34811|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34812|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34813|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34814|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34815|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34816|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34817|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34818|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34819|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34820|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34821|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34822|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34823|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34824|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34825|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34826|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34827|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34828|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34829|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34830|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34831|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34832|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34833|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34834|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34835|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34836|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34837|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34838|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34839|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34840|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34841|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34842|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34843|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34844|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34845|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34846|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34847|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34848|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34849|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34850|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
48402|NCT02100514|B3|Baseline|Total|Total of all reporting groups
34851|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34852|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34853|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34854|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34855|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34856|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34857|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34858|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34859|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34860|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34861|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34862|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34863|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34864|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34865|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34866|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34867|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34868|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34869|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34870|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34871|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34872|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34873|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34874|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34875|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34876|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34877|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34878|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34879|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34880|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34881|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34882|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34883|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34884|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34885|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34886|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34887|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34888|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34889|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34890|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34891|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34892|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34893|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34894|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34895|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34896|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34897|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34898|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34899|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34900|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34901|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34902|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34903|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34904|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34905|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34906|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
48492|NCT02100410|O3|Outcome|TEST5|Iteration 2-87-3 with embossed mark
34907|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34908|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34909|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34910|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34911|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34912|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34913|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34914|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34915|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34916|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34917|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34918|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34919|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34920|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34921|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34922|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34923|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34924|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34925|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34926|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34927|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34928|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34929|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34930|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34931|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34932|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34933|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34934|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34935|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34936|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34937|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34938|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34939|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34940|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34941|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
34942|NCT02209181|E4|Reported Event|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
34943|NCT02209181|E3|Reported Event|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
34944|NCT02209181|E2|Reported Event|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
34945|NCT02209181|E1|Reported Event|Placebo|Three placebo capsules taken orally
34946|NCT02209064|B1|Baseline|EpiAccess|"EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.
Pericardial access: Access to the pericardium to enable further treatments."
34947|NCT02209064|P1|Participant Flow|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.
Pericardial access: Access to the pericardium to enable further treatments."
34948|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.
Pericardial access: Access to the pericardium to enable further treatments."
57314|NCT02033200|O1|Outcome|Active|Stendra 200 mg
34949|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.
Pericardial access: Access to the pericardium to enable further treatments."
34950|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.
Pericardial access: Access to the pericardium to enable further treatments."
34951|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.
Pericardial access: Access to the pericardium to enable further treatments."
34952|NCT02209064|E1|Reported Event|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.
Pericardial access: Access to the pericardium to enable further treatments."
34953|NCT02207907|B3|Baseline|Total|Total of all reporting groups
48493|NCT02100410|O2|Outcome|TEST3|Iteration 2-87-2 with embossed mark
34954|NCT02207907|B2|Baseline|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
34955|NCT02207907|B1|Baseline|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
34956|NCT02207907|P2|Participant Flow|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
34957|NCT02207907|P1|Participant Flow|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
34958|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
34959|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
34960|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
34961|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
34962|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
34963|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
34964|NCT02207907|O2|Outcome|0% Sodium Bicarbonate|Toothpaste containing 1100 ppm fluoride as sodium fluoride
34965|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
34966|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
34967|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
34968|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
34969|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
34970|NCT02207907|E2|Reported Event|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
34971|NCT02207907|E1|Reported Event|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
34972|NCT02207829|B3|Baseline|Total|Total of all reporting groups
34973|NCT02207829|B2|Baseline|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
34974|NCT02207829|B1|Baseline|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
34975|NCT02207829|P2|Participant Flow|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
34976|NCT02207829|P1|Participant Flow|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
34977|NCT02207829|O2|Outcome|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
34978|NCT02207829|O1|Outcome|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
34979|NCT02207829|E2|Reported Event|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
34980|NCT02207829|E1|Reported Event|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
34981|NCT02207608|B3|Baseline|Total|Total of all reporting groups
34982|NCT02207608|B2|Baseline|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
Hyaluronic Acid
BCG (Immucist®)"
34983|NCT02207608|B1|Baseline|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
BCG (Immucist®)"
34984|NCT02207608|P2|Participant Flow|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
Hyaluronic Acid
BCG (Immucist®)"
34985|NCT02207608|P1|Participant Flow|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
BCG (Immucist®)"
34986|NCT02207608|O2|Outcome|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
Hyaluronic Acid
BCG (Immucist®)"
34987|NCT02207608|O1|Outcome|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
BCG (Immucist®)"
34988|NCT02207608|E2|Reported Event|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
Hyaluronic Acid
BCG (Immucist®)"
34989|NCT02207608|E1|Reported Event|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
BCG (Immucist®)"
34990|NCT02207478|B3|Baseline|Total|Total of all reporting groups
34991|NCT02207478|B2|Baseline|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
34992|NCT02207478|B1|Baseline|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
34993|NCT02207478|P2|Participant Flow|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
34994|NCT02207478|P1|Participant Flow|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System.
ENB: ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
34995|NCT02207478|O2|Outcome|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
34996|NCT02207478|O1|Outcome|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
34997|NCT02207478|O2|Outcome|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
34998|NCT02207478|O1|Outcome|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
34999|NCT02207478|E2|Reported Event|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
35000|NCT02207478|E1|Reported Event|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
35001|NCT02207413|B7|Baseline|Total|Total of all reporting groups
35002|NCT02207413|B6|Baseline|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35003|NCT02207413|B5|Baseline|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
48494|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
35004|NCT02207413|B4|Baseline|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35005|NCT02207413|B3|Baseline|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35006|NCT02207413|B2|Baseline|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35007|NCT02207413|B1|Baseline|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35008|NCT02207413|P6|Participant Flow|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35009|NCT02207413|P5|Participant Flow|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35010|NCT02207413|P4|Participant Flow|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35011|NCT02207413|P3|Participant Flow|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35012|NCT02207413|P2|Participant Flow|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35013|NCT02207413|P1|Participant Flow|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35014|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
36115|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
35015|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35016|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35120|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
35017|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35018|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35019|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35020|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35021|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35022|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35023|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35024|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35073|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35025|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35026|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35091|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35121|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
35027|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35028|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6m-<5y Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35029|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6m-<5y Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35030|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35031|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35032|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35033|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35034|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35035|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35036|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35092|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35123|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
35037|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35038|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35039|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35040|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35041|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35042|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35043|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35044|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35072|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35045|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35046|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35047|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35093|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35122|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
35048|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35049|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35050|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35051|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35052|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35053|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35054|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35055|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35056|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35057|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35058|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35059|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35060|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35061|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35062|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35118|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
35119|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
35063|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35064|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35065|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35066|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35067|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35068|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35069|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35070|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35071|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35106|NCT02207400|B3|Baseline|Total|Total of all reporting groups
35107|NCT02207400|B2|Baseline|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
35074|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35075|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35076|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35077|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35078|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35079|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35080|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-4y Group|Subjects in the Influsplit Tetra_LP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35081|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-4y Group|Subjects in the Influsplit Tetra_IP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35082|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35083|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35084|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35085|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35086|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-4y Group|Subjects in the Influsplit Tetra_LP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35108|NCT02207400|B1|Baseline|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
35087|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-4y Group|Subjects in the Influsplit Tetra_IP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35088|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35089|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35090|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35094|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35095|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35096|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35097|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35098|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35099|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35100|NCT02207413|E6|Reported Event|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35101|NCT02207413|E5|Reported Event|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
35102|NCT02207413|E4|Reported Event|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to &lt;9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35103|NCT02207413|E3|Reported Event|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to &lt;9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
35104|NCT02207413|E2|Reported Event|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35105|NCT02207413|E1|Reported Event|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
35109|NCT02207400|P2|Participant Flow|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
35110|NCT02207400|P1|Participant Flow|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
35111|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
35112|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm)fluoride as sodium fluoride
35113|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
35114|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
35115|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
35116|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
35117|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
35124|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
35125|NCT02207400|E2|Reported Event|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
35126|NCT02207400|E1|Reported Event|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
35127|NCT02206776|B3|Baseline|Total|Total of all reporting groups
35128|NCT02206776|B2|Baseline|Ketamine|"A single dose of intranasal ketamine up to 50 mg
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
35129|NCT02206776|B1|Baseline|Midazolam|"A single dose of intranasal midazolam up to 4 mg
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
35130|NCT02206776|P2|Participant Flow|Ketamine|"A single dose of intranasal ketamine up to 50 mg
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
35131|NCT02206776|P1|Participant Flow|Midazolam|"A single dose of intranasal midazolam up to 4 mg
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
35132|NCT02206776|O2|Outcome|Ketamine|"A single dose of intranasal ketamine up to 50 mg
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
35133|NCT02206776|O1|Outcome|Midazolam|"A single dose of intranasal midazolam up to 4 mg
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
35134|NCT02206776|E2|Reported Event|Ketamine|"A single dose of intranasal ketamine up to 50 mg
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
35135|NCT02206776|E1|Reported Event|Midazolam|"A single dose of intranasal midazolam up to 4 mg
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
35136|NCT02206607|B1|Baseline|All Participants|Participants received at least 1 dose of PF-04937319.
35137|NCT02206607|P5|Participant Flow|Sequence DCAB: PF-04937319 330 mg MR3 First|Participants received PF-04937319 330 mg MR3, followed by PF-04937319 300 mg MR2, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 250 mg MR1. There was a 5 to 10-day washout between dosing across the 4 regimens.
35138|NCT02206607|P4|Participant Flow|Sequence CBDA: PF-04937319 300 mg MR2 First|Participants received PF-04937319 300 mg MR2, followed by PF-04937319 250 mg MR1, followed by PF-04937319 330 mg MR3, followed by PF-04937319 150+100 mg IR. There was a 5 to 10-day washout between dosing across the 4 regimens.
35139|NCT02206607|P3|Participant Flow|Sequence BACD: PF-04937319 250 mg MR1 First|Participants received PF-04937319 MR1 250 mg, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 300 mg MR2, followed by PF-04937319 330 mg MR3. There was a 5 to 10-day washout between dosing across the 4 regimens.
35140|NCT02206607|P2|Participant Flow|Sequence ADBC: PF-04937319 150+100 mg IR First|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch, followed by PF-04937319 modified-release formulation #3 (MR3) 330 mg, followed by PF-04937319 modified-release formulation #1 (MR1) 250 mg, followed by PF-04937319 modified-release formulation #2 (MR2) 300 mg. There was a 5 to 10-day washout between dosing across the 4 regimens.
35141|NCT02206607|P1|Participant Flow|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment sequences.
35142|NCT02206607|O5|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35143|NCT02206607|O4|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35144|NCT02206607|O3|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35145|NCT02206607|O2|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35146|NCT02206607|O1|Outcome|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.
35147|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35148|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35850|NCT02201953|P1|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
35149|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35150|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35151|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35152|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35153|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35154|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35220|NCT02205814|E1|Reported Event|Fasitibant Low Dose|"Drug: solution for intra-articular injection
Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
35155|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35156|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35157|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35158|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35159|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35160|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35161|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35162|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35163|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35164|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35165|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35166|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35167|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35168|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35169|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35170|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35171|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35172|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35173|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35174|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35175|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35176|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35177|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35178|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35179|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35180|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35181|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35182|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35183|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35221|NCT02205476|B3|Baseline|Total|Total of all reporting groups
37316|NCT02190604|E16|Reported Event|Part 3 Placebo C1/C2/C3|Part 3 Placebo C1/C2/C3
35184|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35185|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35186|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35187|NCT02206607|E5|Reported Event|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35188|NCT02206607|E4|Reported Event|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35189|NCT02206607|E3|Reported Event|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
35190|NCT02206607|E2|Reported Event|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
35191|NCT02206607|E1|Reported Event|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.
35192|NCT02205814|B5|Baseline|Total|Total of all reporting groups
35193|NCT02205814|B4|Baseline|PLACEBO|"Drug: solution for intra-articular injection
Placebo comparator: Single intra-articular injection of placebo"
35194|NCT02205814|B3|Baseline|Fasitibant High Dose|"Drug: solution for intra-articular injection
Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
35195|NCT02205814|B2|Baseline|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection
Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
35196|NCT02205814|B1|Baseline|Fasitibant Low Dose|"Drug: solution for intra-articular injection
Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
35197|NCT02205814|P4|Participant Flow|PLACEBO|"Drug: solution for intra-articular injection
Placebo comparator: Single intra-articular injection of placebo"
35198|NCT02205814|P3|Participant Flow|Fasitibant High Dose|"Drug: solution for intra-articular injection
Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
35199|NCT02205814|P2|Participant Flow|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection
Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
35200|NCT02205814|P1|Participant Flow|Fasitibant Low Dose|"Drug: solution for intra-articular injection
Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
35201|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection
Placebo comparator: Single intra-articular injection of placebo"
35202|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection
Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
35203|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection
Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
35204|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection
Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
35205|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection
Placebo comparator: Single intra-articular injection of placebo"
35206|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection
Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
35207|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection
Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
35208|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection
Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
35209|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection
Placebo comparator: Single intra-articular injection of placebo"
35210|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection
Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
35902|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
35211|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection
Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
35212|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection
Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
35213|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection
Placebo comparator: Single intra-articular injection of placebo"
35214|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection
Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
35215|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection
Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
35216|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection
Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
35217|NCT02205814|E4|Reported Event|PLACEBO|"Drug: solution for intra-articular injection
Placebo comparator: Single intra-articular injection of placebo"
35218|NCT02205814|E3|Reported Event|Fasitibant High Dose|"Drug: solution for intra-articular injection
Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
35219|NCT02205814|E2|Reported Event|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection
Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
37317|NCT02190604|E15|Reported Event|Part 2 QBW251 750mg BID|Part 2 QBW251 750mg BID
35222|NCT02205476|B2|Baseline|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
35223|NCT02205476|B1|Baseline|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
35224|NCT02205476|P2|Participant Flow|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
35225|NCT02205476|P1|Participant Flow|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
35226|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35227|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35228|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35229|NCT02205476|O1|Outcome|Group 1: PF­-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
35230|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
35231|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
35232|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
35330|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
57315|NCT02033200|O2|Outcome|Placebo|placebo
35233|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
35234|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
35235|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
35236|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
53686|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
35237|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35238|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35239|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
35240|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35241|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35242|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35243|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
35244|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35245|NCT02205476|O3|Outcome|Group 2: PF-06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35246|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35247|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
35248|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35249|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35331|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35250|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
35251|NCT02205476|O1|Outcome|Group 1: PF­-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
35252|NCT02205476|E2|Reported Event|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
35253|NCT02205476|E1|Reported Event|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
35254|NCT02205333|B10|Baseline|Total|Total of all reporting groups
35255|NCT02205333|B9|Baseline|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35849|NCT02201953|P2|Participant Flow|SOF+RBV 24 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
35256|NCT02205333|B8|Baseline|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35257|NCT02205333|B7|Baseline|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35258|NCT02205333|B6|Baseline|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35259|NCT02205333|B5|Baseline|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35260|NCT02205333|B4|Baseline|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35261|NCT02205333|B3|Baseline|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35262|NCT02205333|B2|Baseline|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35263|NCT02205333|B1|Baseline|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35264|NCT02205333|P9|Participant Flow|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35265|NCT02205333|P8|Participant Flow|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35266|NCT02205333|P7|Participant Flow|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35267|NCT02205333|P6|Participant Flow|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35268|NCT02205333|P5|Participant Flow|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35269|NCT02205333|P4|Participant Flow|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35270|NCT02205333|P3|Participant Flow|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35271|NCT02205333|P2|Participant Flow|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35272|NCT02205333|P1|Participant Flow|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35273|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35443|NCT02205333|E1|Reported Event|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35274|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35275|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35276|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35277|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35278|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35279|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35280|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35281|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35282|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35311|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
53687|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
35283|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35284|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35285|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35286|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35287|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35288|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35289|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35290|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35291|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35292|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35293|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35294|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35295|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35296|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35297|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35298|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35299|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35300|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35471|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
35301|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35302|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35303|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35304|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35305|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35306|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35307|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35308|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35309|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35310|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
53688|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
35312|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35313|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35314|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35315|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35316|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35317|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35318|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35319|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35320|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35321|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35322|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35323|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35324|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35325|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35326|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35327|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35328|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35329|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35332|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35333|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35334|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35335|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35336|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35337|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35338|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35339|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35425|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35340|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35341|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35342|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35343|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35344|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35345|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35346|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35347|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35348|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35349|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35350|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35351|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35352|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35353|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35354|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35355|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35356|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35357|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35358|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35359|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35360|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35361|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35362|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35363|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35364|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35365|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35366|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35367|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35503|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
35504|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
35368|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35369|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35370|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35371|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35372|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35373|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35374|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35375|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35376|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35377|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35378|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35379|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35380|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35381|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35382|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35383|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35384|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35385|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35386|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35472|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
35473|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
35474|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
35387|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35388|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35389|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35390|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35391|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35392|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35393|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35394|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35395|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35505|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
35506|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
35396|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35397|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35398|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35399|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35400|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35401|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35402|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35403|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35404|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35405|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35406|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35407|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35408|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35409|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35410|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35411|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35412|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35413|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35475|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
35476|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
35477|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
35414|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35415|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35416|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35417|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35418|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35419|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35420|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35421|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35422|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35423|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35424|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35426|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35427|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35428|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35429|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35430|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35431|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35432|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35433|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35434|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
35435|NCT02205333|E9|Reported Event|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35436|NCT02205333|E8|Reported Event|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
35437|NCT02205333|E7|Reported Event|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35438|NCT02205333|E6|Reported Event|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
35439|NCT02205333|E5|Reported Event|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
35440|NCT02205333|E4|Reported Event|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
35441|NCT02205333|E3|Reported Event|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
35442|NCT02205333|E2|Reported Event|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
35478|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
35444|NCT02204748|B1|Baseline|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35445|NCT02204748|P1|Participant Flow|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35446|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35447|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35448|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35449|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35450|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35451|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35452|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35507|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
35508|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
35453|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35454|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35455|NCT02204748|E1|Reported Event|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.
DePuy Attune posterior stabilizing fixed bearing knee system"
35456|NCT02204657|B3|Baseline|Total|Total of all reporting groups
35457|NCT02204657|B2|Baseline|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
35458|NCT02204657|B1|Baseline|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.
Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
35459|NCT02204657|P2|Participant Flow|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
35460|NCT02204657|P1|Participant Flow|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.
Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
35461|NCT02204657|O2|Outcome|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
35462|NCT02204657|O1|Outcome|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.
Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
35463|NCT02204657|O2|Outcome|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
35464|NCT02204657|O1|Outcome|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.
Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
35465|NCT02204657|E2|Reported Event|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
35466|NCT02204657|E1|Reported Event|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.
Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
35467|NCT02204579|B1|Baseline|NPSP795|
35468|NCT02204579|P1|Participant Flow|NPSP795|
35469|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
35470|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
35520|NCT02204449|B2|Baseline|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
35521|NCT02204449|B1|Baseline|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.
Cardiac Rehabilitation Peer Mentorship"
35522|NCT02204449|P2|Participant Flow|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
35523|NCT02204449|P1|Participant Flow|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.
Cardiac Rehabilitation Peer Mentorship"
35524|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
35525|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.
Cardiac Rehabilitation Peer Mentorship"
35526|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
35527|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.
Cardiac Rehabilitation Peer Mentorship"
35528|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
35529|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.
Cardiac Rehabilitation Peer Mentorship"
35530|NCT02204449|E2|Reported Event|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
35572|NCT02204007|O1|Outcome|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model
3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
35531|NCT02204449|E1|Reported Event|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.
Cardiac Rehabilitation Peer Mentorship"
35532|NCT02204410|B1|Baseline|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
35533|NCT02204410|P1|Participant Flow|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
35534|NCT02204410|O1|Outcome|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
35535|NCT02204410|O1|Outcome|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
35536|NCT02204410|E1|Reported Event|Omega-3 Fatty Acids and Stimulant Treatment|Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
35537|NCT02204371|B1|Baseline|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35538|NCT02204371|P1|Participant Flow|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35539|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35540|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35541|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35542|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35543|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35544|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35545|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35546|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35547|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35548|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35549|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35550|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35551|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35552|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35553|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35554|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35555|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35556|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35557|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35558|NCT02204371|O1|Outcome|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35559|NCT02204371|E1|Reported Event|GW786034 50 mg Once Daily|Participants with hereditary hemorrhagic telangiectasia (HHT) received GW786034 50 mg tablet orally once daily at least one hour before or two hours after a meal in the morning for up to 12 weeks in the open label non-randomized phase.
35560|NCT02204319|B1|Baseline|Cold Laser Recipients|"10 enrolled in the study. Seven completed the study and three withdrew. Each participant received six cold laser light therapy treatments and were assessed pre and post treatment with Q tip testing at each treatment visit. There was also a two week follow up scheduled for re-assessment.
Treatment for each patient was not standardized since there were four therapists involved in data collection and treatment. The treatments included manual therapy mobilizations, neuromuscular rehabilitation with or without EMG biofeedback, home care training which may have included lubricant usage, dilator training, and exercises for the pelvic floor as well as methods of pain relieving modalities."
35561|NCT02204319|P1|Participant Flow|Cold Laser Treatment|"Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.
Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device."
35562|NCT02204319|O1|Outcome|Cold Laser Recipients|"10 enrolled in the study. Seven completed the study and three withdrew. Each participant received six cold laser light therapy treatments and were assessed pre and post treatment with Q tip testing. There was a two week follow up scheduled for assessment.
Treatment for each patient was not standardized since there were four therapists involved in data collection and treatment. The treatments included manual therapy mobilizations, neuromuscular rehabilitation with or without EMG biofeedback, home care training which may have included lubricant usage, dilator training, and exercises for the pelvic floor as well as methods of pain relieving modalities."
35563|NCT02204319|O1|Outcome|Cold Laser Treatment|"Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.
Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device."
35564|NCT02204319|O1|Outcome|Cold Laser Treatment|"Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.
Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device."
35565|NCT02204319|E1|Reported Event|Cold Laser Light Therapy|The laser unit emits three independent 7 mW, 635 nm red light diodes in a hand-held device and is a variable frequency pulsed wave device. Erchonia low level lasers have been determined safe and effective and non-significant risk (NSR) by the Food and Drug Administration (FDA) for application for numerous and various pain reduction indications, providing justification for the anticipated safety and effectiveness of application The cold laser was administered over 10 minutes as follows: 5 minutes at the area of sacral nerve roots 2-4 in the side-lying position- hertz settings: 14, 8, 12, 28; and 5 minutes at the vulva in the lithotomy position, hertz settings 2: 9,16,33,60 while the outer labia were held open by the therapist. A sweeping motion was used during administration. The laser head was positioned approximately 3 inches from the skin surface and did not touch the skin. The patient wore safety goggles while the laser treatment was provided.
35566|NCT02204007|B3|Baseline|Total|Total of all reporting groups
35567|NCT02204007|B2|Baseline|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
35568|NCT02204007|B1|Baseline|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model
3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
35569|NCT02204007|P2|Participant Flow|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
35570|NCT02204007|P1|Participant Flow|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model
3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
35571|NCT02204007|O2|Outcome|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
35573|NCT02204007|O2|Outcome|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
35574|NCT02204007|O1|Outcome|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model
3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
35575|NCT02204007|E2|Reported Event|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
35576|NCT02204007|E1|Reported Event|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model
3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
35577|NCT02203916|B4|Baseline|Total|Total of all reporting groups
35578|NCT02203916|B3|Baseline|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
35579|NCT02203916|B2|Baseline|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
35580|NCT02203916|B1|Baseline|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
35581|NCT02203916|P3|Participant Flow|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
35582|NCT02203916|P2|Participant Flow|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
35583|NCT02203916|P1|Participant Flow|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
35584|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
35585|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
35586|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
35587|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
35588|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
35589|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
35590|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
35591|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
35592|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
35593|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
35594|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
35595|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
35596|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
35597|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
35598|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
35599|NCT02203916|E3|Reported Event|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
35600|NCT02203916|E2|Reported Event|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
35601|NCT02203916|E1|Reported Event|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
35602|NCT02203786|B5|Baseline|Total|Total of all reporting groups
35603|NCT02203786|B4|Baseline|Fluphenazine - Controls|A total of 15 control subjects were enrolled in this arm.
35604|NCT02203786|B3|Baseline|Haloperidol - Controls|A total of 15 control subjects were enrolled in this arm.
35605|NCT02203786|B2|Baseline|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35606|NCT02203786|B1|Baseline|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35607|NCT02203786|P4|Participant Flow|Fluphenazine - Controls|"Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).
All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
35608|NCT02203786|P3|Participant Flow|Haloperidol - Controls|"Dose 1: 3 mg haloperidol (3 capsules @ 1 mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.
Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses). Dexedrine: Dose/maximum dose 20 mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
35609|NCT02203786|P2|Participant Flow|Fluphenazine - Pathological Gamblers|"Dose 1: 3 mg fluphenazine (3 capsules @ 1 mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).
All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
35610|NCT02203786|P1|Participant Flow|Haloperidol - Pathological Gamblers|"Dose 1: 3 mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.
Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).
Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
35611|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
35612|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
35613|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35614|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35615|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 control subjects were enrolled in this arm.
35616|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 control subjects were enrolled in this arm.
35617|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35618|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35619|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
35620|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
35621|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35622|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35623|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
35624|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
35625|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35626|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35627|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
35628|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
35629|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35630|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35631|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
35632|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
35633|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35634|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
35635|NCT02203786|E4|Reported Event|Fluphenazine - Controls|"Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).
Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).
All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
35636|NCT02203786|E3|Reported Event|Haloperidol - Controls|"Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).
Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).
Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
35637|NCT02203786|E2|Reported Event|Fluphenazine - Pathological Gamblers|"Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).
Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).
All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
35670|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35947|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35638|NCT02203786|E1|Reported Event|Haloperidol - Pathological Gamblers|"Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).
Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).
Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
35639|NCT02203747|B3|Baseline|Total|Total of all reporting groups
35640|NCT02203747|B2|Baseline|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with bilateral non-toric IOL
Administration of patient self-assessment"
35641|NCT02203747|B1|Baseline|Pseudophakic Implanted With Toric IOL|"Subjects implanted with bilateral toric IOL
Administration of patient self-assessment"
35642|NCT02203747|P2|Participant Flow|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with bilateral non-toric IOL
Administration of patient self-assessment"
35643|NCT02203747|P1|Participant Flow|Pseudophakic Implanted With Toric IOL|"Subjects implanted with bilateral toric IOL
Administration of patient self-assessment"
35644|NCT02203747|O2|Outcome|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL
Administration of patient self-assessment"
35645|NCT02203747|O1|Outcome|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL
Administration of patient self-assessment"
35646|NCT02203747|O2|Outcome|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL
Administration of patient self-assessment"
35647|NCT02203747|O1|Outcome|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL
Administration of patient self-assessment"
35648|NCT02203747|E2|Reported Event|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL
Administration of patient self-assessment"
35649|NCT02203747|E1|Reported Event|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL
Administration of patient self-assessment"
35650|NCT02203721|B3|Baseline|Total|Total of all reporting groups
35651|NCT02203721|B2|Baseline|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
35652|NCT02203721|B1|Baseline|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
35653|NCT02203721|P2|Participant Flow|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
35654|NCT02203721|P1|Participant Flow|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
35655|NCT02203721|O2|Outcome|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
35656|NCT02203721|O1|Outcome|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
35657|NCT02203721|O2|Outcome|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
35658|NCT02203721|O1|Outcome|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
35659|NCT02203721|E2|Reported Event|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
35660|NCT02203721|E1|Reported Event|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
35661|NCT02203578|B1|Baseline|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35662|NCT02203578|P1|Participant Flow|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35663|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35664|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35665|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35666|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35667|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35668|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35669|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35671|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35672|NCT02203578|E1|Reported Event|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV
laboratory biomarker analysis: Correlative studies"
35673|NCT02203565|B1|Baseline|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.
Dakin's solution: Applied topically
radiation therapy: Undergo radiation therapy
questionnaire administration: Ancillary studies
laboratory biomarker analysis: Optional correlative studies"
35674|NCT02203565|P1|Participant Flow|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.
Dakin's solution: Applied topically
radiation therapy: Undergo radiation therapy
questionnaire administration: Ancillary studies
laboratory biomarker analysis: Optional correlative studies"
35675|NCT02203565|O1|Outcome|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.
Dakin's solution: Applied topically
radiation therapy: Undergo radiation therapy
questionnaire administration: Ancillary studies
laboratory biomarker analysis: Optional correlative studies"
35676|NCT02203565|E1|Reported Event|Supportive Care (Dakin's Solution, Radiation Therapy)|"Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.
Dakin's solution: Applied topically
radiation therapy: Undergo radiation therapy
questionnaire administration: Ancillary studies
laboratory biomarker analysis: Optional correlative studies"
35677|NCT02203162|B1|Baseline|Subjects|all subjects underwent cough challenge testing at baseline and after e-cig exposure
35678|NCT02203162|P1|Participant Flow|Electronic Cigarette Exposure|30 healthy subjects-adult nonsmokers
35679|NCT02203162|O1|Outcome|Electronic Cigarette Exposure|30 subjects-healthy adult nonsmokers
35680|NCT02203162|E1|Reported Event|Subjects|30 subjects-adult nonsmokers
35681|NCT02203149|B6|Baseline|Total|Total of all reporting groups
35682|NCT02203149|B5|Baseline|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35683|NCT02203149|B4|Baseline|Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
35684|NCT02203149|B3|Baseline|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35685|NCT02203149|B2|Baseline|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35686|NCT02203149|B1|Baseline|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35687|NCT02203149|P5|Participant Flow|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35688|NCT02203149|P4|Participant Flow|Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
35689|NCT02203149|P3|Participant Flow|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35690|NCT02203149|P2|Participant Flow|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35691|NCT02203149|P1|Participant Flow|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35692|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35693|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period of Part 2, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks.
35694|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35695|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35696|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period of Part 2, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks.
35697|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35698|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
35699|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2.
35700|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
35701|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
35702|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
35703|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
35704|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35705|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35706|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35707|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35708|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1.
35709|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1.
35710|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1.
35711|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1.
35712|NCT02203149|O5|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35713|NCT02203149|O4|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
35714|NCT02203149|O3|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35715|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35716|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35717|NCT02203149|E6|Reported Event|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35718|NCT02203149|E5|Reported Event|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks. One participant who received placebo during the blinded period did not receive active treatment during the open-label period.
35719|NCT02203149|E4|Reported Event|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants in the Deferred Treatment Arm take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
35720|NCT02203149|E3|Reported Event|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
35721|NCT02203149|E2|Reported Event|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35722|NCT02203149|E1|Reported Event|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
35805|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
53689|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
35723|NCT02203032|B1|Baseline|Ustekinumab (Open Label Run-in)|All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.
35724|NCT02203032|P4|Participant Flow|Ustekinumab (Nonrandomized Open Label Continuation)|Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.
35725|NCT02203032|P3|Participant Flow|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
35726|NCT02203032|P2|Participant Flow|100 mg Guselkumab (Randomized)|Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
35727|NCT02203032|P1|Participant Flow|Ustekinumab (Open Label Run-in)|All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.
35728|NCT02203032|O2|Outcome|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
35729|NCT02203032|O1|Outcome|Guselkumab (Randomized)|Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
35730|NCT02203032|O2|Outcome|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
35731|NCT02203032|O1|Outcome|Guselkumab (Randomized)|Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
35732|NCT02203032|O2|Outcome|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
35733|NCT02203032|O1|Outcome|Guselkumab (Randomized)|Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
35734|NCT02203032|O2|Outcome|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
35735|NCT02203032|O1|Outcome|Guselkumab (Randomized)|Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
35736|NCT02203032|E4|Reported Event|Ustekinumab (Nonrandomized Open Label Continuation)|Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.
35737|NCT02203032|E3|Reported Event|Ustekinumab (Randomized)|Participants from open label run-in phase with an IGA >=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
35738|NCT02203032|E2|Reported Event|100 mg Guselkumab (Randomized)|Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
35739|NCT02203032|E1|Reported Event|Ustekinumab (Open Label Run-in)|All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (participants weighing >100 kg) at Weeks 0 and 4. At Week 16, participants with IGA >=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.
35740|NCT02202785|B4|Baseline|Total|Total of all reporting groups
35741|NCT02202785|B3|Baseline|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35742|NCT02202785|B2|Baseline|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35743|NCT02202785|B1|Baseline|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35744|NCT02202785|P3|Participant Flow|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35745|NCT02202785|P2|Participant Flow|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35746|NCT02202785|P1|Participant Flow|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35747|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35748|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35749|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35750|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35751|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35752|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35753|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35754|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35822|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
35823|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
35755|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle,for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35756|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35757|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35758|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle,for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35759|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35760|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35761|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35762|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35763|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35764|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35765|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35766|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35824|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
35825|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
35767|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35768|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35769|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35770|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35771|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35772|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35773|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35774|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35775|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35776|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35777|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35778|NCT02202785|E1|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35779|NCT02202759|B4|Baseline|Total|Total of all reporting groups
35780|NCT02202759|B3|Baseline|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
37318|NCT02190604|E14|Reported Event|Part 2 QBW251 450mg BID|Part 2 QBW251 450mg BID
35781|NCT02202759|B2|Baseline|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35782|NCT02202759|B1|Baseline|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35783|NCT02202759|P3|Participant Flow|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35784|NCT02202759|P2|Participant Flow|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35785|NCT02202759|P1|Participant Flow|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35786|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35787|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35788|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35789|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35790|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35791|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35826|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
35827|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
35828|NCT02202538|E1|Reported Event|All Subjects|All subjects enrolled in the study used the Indego
35792|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35793|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35794|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35795|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35796|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35797|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35798|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35799|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35800|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35801|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35802|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35803|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35804|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35829|NCT02202252|B3|Baseline|Total|Total of all reporting groups
37319|NCT02190604|E13|Reported Event|Part 2 QBW251 750mg|Part 2 QBW251 750mg
35806|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35807|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35808|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35809|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35810|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35811|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35812|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35813|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35814|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35815|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35816|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
35817|NCT02202759|E1|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
35818|NCT02202538|B1|Baseline|All Subjects|All subjects enrolled in the study used the Indego
35819|NCT02202538|P1|Participant Flow|All Subjects|All subjects enrolled in the study used the Indego
35820|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
35821|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
35830|NCT02202252|B2|Baseline|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
35831|NCT02202252|B1|Baseline|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
35832|NCT02202252|P2|Participant Flow|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
35833|NCT02202252|P1|Participant Flow|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
35834|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
35835|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
35836|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
35837|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
35838|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
35839|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
35840|NCT02202252|E2|Reported Event|Double Drain|Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.
35841|NCT02202252|E1|Reported Event|Single Drain|Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.
35842|NCT02202135|B1|Baseline|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
35843|NCT02202135|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
35844|NCT02202135|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
35845|NCT02202135|E1|Reported Event|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
35846|NCT02201953|B3|Baseline|Total|Total of all reporting groups
35847|NCT02201953|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
35848|NCT02201953|B1|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35948|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35851|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
35852|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35853|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
35854|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35855|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
35856|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35857|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
35858|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35859|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
35860|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35861|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
35862|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35863|NCT02201953|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
35864|NCT02201953|E1|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35865|NCT02201940|B3|Baseline|Total|Total of all reporting groups
35866|NCT02201940|B2|Baseline|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
35867|NCT02201940|B1|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35868|NCT02201940|P2|Participant Flow|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
35869|NCT02201940|P1|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
35870|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
35871|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35872|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
35873|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35874|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
35875|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35876|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
35877|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35878|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
35879|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35880|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
35881|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35882|NCT02201940|E2|Reported Event|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
35883|NCT02201940|E1|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
35884|NCT02201901|B4|Baseline|Total|Total of all reporting groups
35885|NCT02201901|B3|Baseline|SOF/VEL 24 Weeks ((Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
35886|NCT02201901|B2|Baseline|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
35887|NCT02201901|B1|Baseline|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
35888|NCT02201901|P3|Participant Flow|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
35889|NCT02201901|P2|Participant Flow|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
35890|NCT02201901|P1|Participant Flow|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
35891|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
35892|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
35893|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
35894|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
35895|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
35896|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
35897|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
35898|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
35899|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
35900|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
35901|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
35903|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
35904|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
35905|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
35906|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
35907|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
35908|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
35909|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
35910|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
35911|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
35912|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
35913|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
35914|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
35915|NCT02201901|E3|Reported Event|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
35916|NCT02201901|E2|Reported Event|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
35917|NCT02201901|E1|Reported Event|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
35918|NCT02201784|B3|Baseline|Total|Total of all reporting groups
35919|NCT02201784|B2|Baseline|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%
Ropivacaine: Comparison of equipotent doses"
35920|NCT02201784|B1|Baseline|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%
Levobupivacaine: Comparison of Equipotent doses"
35921|NCT02201784|P2|Participant Flow|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%
Ropivacaine: Comparison of equipotent doses"
35922|NCT02201784|P1|Participant Flow|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%
Levobupivacaine: Comparison of Equipotent doses"
35923|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%
Ropivacaine: Comparison of equipotent doses"
35924|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%
Levobupivacaine: Comparison of Equipotent doses"
35925|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%
Ropivacaine: Comparison of equipotent doses"
35926|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%
Levobupivacaine: Comparison of Equipotent doses"
35927|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%
Ropivacaine: Comparison of equipotent doses"
35928|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%
Levobupivacaine: Comparison of Equipotent doses"
35929|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%
Ropivacaine: Comparison of equipotent doses"
35930|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%
Levobupivacaine: Comparison of Equipotent doses"
35931|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%
Ropivacaine: Comparison of equipotent doses"
35932|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%
Levobupivacaine: Comparison of Equipotent doses"
35933|NCT02201784|E2|Reported Event|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%
Ropivacaine: Comparison of equipotent doses"
35934|NCT02201784|E1|Reported Event|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%
Levobupivacaine: Comparison of Equipotent doses"
35935|NCT02201524|B5|Baseline|Total|Total of all reporting groups
35936|NCT02201524|B4|Baseline|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35937|NCT02201524|B3|Baseline|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35938|NCT02201524|B2|Baseline|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35939|NCT02201524|B1|Baseline|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35940|NCT02201524|P4|Participant Flow|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35941|NCT02201524|P3|Participant Flow|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35942|NCT02201524|P2|Participant Flow|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35943|NCT02201524|P1|Participant Flow|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35944|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35945|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35946|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35949|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35950|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
57316|NCT02033200|O1|Outcome|Active|Stendra 200 mg
35951|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35952|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35953|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35954|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35955|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35956|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35957|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35958|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35959|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35960|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35961|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35962|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35963|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35964|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35965|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35966|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35967|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35968|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35969|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35970|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35971|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35972|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35973|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35974|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35975|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35976|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35977|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35978|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35979|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35980|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35981|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35982|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35983|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35984|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35985|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35986|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35987|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35988|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35989|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35990|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35991|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35992|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35993|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35994|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
36107|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
35995|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
35996|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
35997|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
35998|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
35999|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
36000|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
36001|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
36002|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
36003|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
36004|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
36005|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
36006|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
36007|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
36008|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
36009|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
36010|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
36011|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
36012|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
36013|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
36014|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
36015|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
36016|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
36017|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
36018|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
36019|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
36020|NCT02201524|E4|Reported Event|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
36021|NCT02201524|E3|Reported Event|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
36022|NCT02201524|E2|Reported Event|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
36023|NCT02201524|E1|Reported Event|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
36024|NCT02201446|B3|Baseline|Total|Total of all reporting groups
36025|NCT02201446|B2|Baseline|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36026|NCT02201446|B1|Baseline|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36027|NCT02201446|P2|Participant Flow|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36028|NCT02201446|P1|Participant Flow|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36029|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36030|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36031|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36032|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36033|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36116|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
36034|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36035|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36036|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36037|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36038|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36039|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36040|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36041|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36042|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36043|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36044|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36045|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36046|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36047|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36048|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36049|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36050|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36051|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36052|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36053|NCT02201446|E2|Reported Event|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
36108|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
36109|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
36110|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
36113|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
36114|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
36054|NCT02201446|E1|Reported Event|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
36055|NCT02201420|B1|Baseline|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.
Tc 99m tilmanocept"
36056|NCT02201420|P1|Participant Flow|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.
Tc 99m tilmanocept"
36057|NCT02201420|O1|Outcome|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.
Tc 99m tilmanocept"
36058|NCT02201420|O1|Outcome|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.
Tc 99m tilmanocept"
36059|NCT02201420|E1|Reported Event|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.
Tc 99m tilmanocept"
36060|NCT02201056|B8|Baseline|Total|Total of all reporting groups
36061|NCT02201056|B7|Baseline|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
36062|NCT02201056|B6|Baseline|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
36063|NCT02201056|B5|Baseline|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
36064|NCT02201056|B4|Baseline|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
36065|NCT02201056|B3|Baseline|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
36066|NCT02201056|B2|Baseline|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
36067|NCT02201056|B1|Baseline|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
36068|NCT02201056|P7|Participant Flow|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
36069|NCT02201056|P6|Participant Flow|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
36070|NCT02201056|P5|Participant Flow|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
36071|NCT02201056|P4|Participant Flow|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
36072|NCT02201056|P3|Participant Flow|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
36073|NCT02201056|P2|Participant Flow|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
36074|NCT02201056|P1|Participant Flow|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
36075|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
36076|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
36077|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
36078|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
36079|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
36080|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
36081|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
36082|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
36083|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
36084|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
36085|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
36086|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
36087|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
36088|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
36089|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
36090|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
36091|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
36092|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
36093|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
36094|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
36095|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
36096|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
36097|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
36098|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
36099|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
36100|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
36101|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
36102|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
36103|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
36104|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
36105|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
36106|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
36117|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
36118|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
36119|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
36120|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
36121|NCT02201056|E7|Reported Event|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
36122|NCT02201056|E6|Reported Event|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
36123|NCT02201056|E5|Reported Event|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
36124|NCT02201056|E4|Reported Event|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
36125|NCT02201056|E3|Reported Event|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
36126|NCT02201056|E2|Reported Event|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
36127|NCT02201056|E1|Reported Event|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
36128|NCT02200536|B4|Baseline|Total|Total of all reporting groups
36129|NCT02200536|B3|Baseline|Control 2|No intervention.
36130|NCT02200536|B2|Baseline|Control 1|"Infant oral health pamphlet
Infant oral health pamphlet: Infant oral health pamphlet"
36131|NCT02200536|B1|Baseline|Test|"Infant oral health promotion package
Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
36132|NCT02200536|P3|Participant Flow|Control 2|No intervention.
36133|NCT02200536|P2|Participant Flow|Control 1|"Infant oral health pamphlet
Infant oral health pamphlet: Infant oral health pamphlet"
36134|NCT02200536|P1|Participant Flow|Test|"Infant oral health promotion package
Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
36135|NCT02200536|O3|Outcome|Control 2|No intervention.
36136|NCT02200536|O2|Outcome|Control 1|"Infant oral health pamphlet
Infant oral health pamphlet: Infant oral health pamphlet"
36137|NCT02200536|O1|Outcome|Test|"Infant oral health promotion package
Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
36138|NCT02200536|O3|Outcome|Control 2|No intervention.
36139|NCT02200536|O2|Outcome|Control 1|"Infant oral health pamphlet
Infant oral health pamphlet: Infant oral health pamphlet"
36140|NCT02200536|O1|Outcome|Test|"Infant oral health promotion package
Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
36141|NCT02200536|E3|Reported Event|Control 2|No intervention.
36142|NCT02200536|E2|Reported Event|Control 1|"Infant oral health pamphlet
Infant oral health pamphlet: Infant oral health pamphlet"
36143|NCT02200536|E1|Reported Event|Test|"Infant oral health promotion package
Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
36144|NCT02200458|B1|Baseline|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.
VeinViewer"
36145|NCT02200458|P1|Participant Flow|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.
VeinViewer"
36146|NCT02200458|O1|Outcome|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.
VeinViewer"
36147|NCT02200458|E1|Reported Event|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.
VeinViewer"
36148|NCT02200328|B3|Baseline|Total|Total of all reporting groups
36149|NCT02200328|B2|Baseline|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
36150|NCT02200328|B1|Baseline|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
36151|NCT02200328|P2|Participant Flow|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
36152|NCT02200328|P1|Participant Flow|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
36153|NCT02200328|O2|Outcome|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
36154|NCT02200328|O1|Outcome|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
36155|NCT02200328|O2|Outcome|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
36156|NCT02200328|O1|Outcome|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
36157|NCT02200328|E2|Reported Event|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
36158|NCT02200328|E1|Reported Event|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
36159|NCT02199717|B1|Baseline|Boys With Hemophilia|
36166|NCT02199574|B1|Baseline|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).
EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
36167|NCT02199574|P1|Participant Flow|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).
EXPAREL"
36168|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).
EXPAREL"
57317|NCT02033200|O2|Outcome|Placebo|placebo
36169|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).
EXPAREL"
36170|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).
EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
36171|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).
EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
36172|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).
EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
36173|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).
EXPAREL: 133 mg EXPAREL in 10 mL."
36174|NCT02199574|E1|Reported Event|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).
EXPAREL"
36175|NCT02199509|B1|Baseline|Primary Oromandibular Dystonia or Cranial Dystonia|All participants enrolled in the study.
36176|NCT02199509|P2|Participant Flow|Placebo Then Levetiracetam Group|Patients with Primary Oromandibular Dystonia or Cervical Dystonia were given Placebo for maximum dose for three weeks followed by Levetiracetam.
36177|NCT02199509|P1|Participant Flow|Levetiracetam Then Placebo Group|Patients with Primary Oromandibular Dystonia or Cervical Dystonia were given Levetiracetam at maximum tolerated dose for three weeks followed by a Placebo.
36178|NCT02199509|O4|Outcome|Placebo Group at 6 or 14 Weeks|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
36179|NCT02199509|O3|Outcome|Placebo Group at 3 or 11 Weeks|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
36180|NCT02199509|O2|Outcome|Levetiracetam Group at 6 or 14 Weeks|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
36181|NCT02199509|O1|Outcome|Levetiracetam Group at 3 or 11 Weeks|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
36182|NCT02199509|O2|Outcome|Placebo Group|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
36183|NCT02199509|O1|Outcome|Levetiracetam Group|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
36226|NCT02198430|E1|Reported Event|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
36227|NCT02198235|B4|Baseline|Total|Total of all reporting groups
36228|NCT02198235|B3|Baseline|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36229|NCT02198235|B2|Baseline|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36230|NCT02198235|B1|Baseline|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)
Dexamethasone"
36184|NCT02199509|O2|Outcome|Placebo Group|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
36185|NCT02199509|O1|Outcome|Levetiracetam Group|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
36186|NCT02199509|E2|Reported Event|Placebo|Subjects received a starting dose of 500 mg twice daily of placebo. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
36187|NCT02199509|E1|Reported Event|Levetiracetam|Subjects received a starting dose of 500 mg twice daily of levetiracetam. The dose was increased by 250 mg twice daily, every three days until the subject reached a total daily dose of 4000 mg (2000 mg twice daily). The titration took approximately three weeks. At the end of week three, subjects returned to NIH for evaluation. The evaluation included a neurological evaluation using the dystonia rating scales and evaluation of any adverse events including but not limited to depression, hallucination, suicidal ideation or psychosis. Subjects remained on the maximum tolerated dose for three weeks. They returned to NIH at week six for the same evaluation as week three, after which subjects were asked to discontinue the medication in a taper-off fashion over a period of a week and then remain off the medication for another week.
36188|NCT02198963|B1|Baseline|RUT058-60 vs Negative and Positve Controls|All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
36189|NCT02198963|P1|Participant Flow|RUT058-60 vs Negative Control vs Positive Control|Each subject was their own control and received occlusive patches containing approximately 200 mg of all three (test article, negative control, and positive control) applied to abraded and non abraded skin sites in the scapular region of each subject's back.
36190|NCT02198963|O6|Outcome|Physiological Saline (0.9%), USP- Non-Abraded|0.02 mL of the Negative Control applied to non-abraded skin sites.
36191|NCT02198963|O5|Outcome|Sodium Lauryl Sulfate (0.1%)- Non-Abraded|0.02 mL of the Positive Control applied to non-abraded skin sites.
36192|NCT02198963|O4|Outcome|Hypochlorous Acid Solution 106 mg/L- Non-Abraded|0.02 mL of the Test Product RUT058-60 applied to non-abraded skin sites.
36193|NCT02198963|O3|Outcome|Physiological Saline (0.9%), USP-Abraded|0.02 mL of the Negative Control applied to abraded skin sites.
36194|NCT02198963|O2|Outcome|Sodium Lauryl Sulfate (0.1%) -Abraded|0.02 mL of the Positive Control applied to abraded skin sites.
36195|NCT02198963|O1|Outcome|Hypochlorous Acid Solution 106 mg/L-Abraded|0.02 mL of the Test Product RUT058-60 applied to abraded skin sites.
36196|NCT02198963|E1|Reported Event|RUT058-60 vs Negative and Positve Controls|All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
36197|NCT02198833|B3|Baseline|Total|Total of all reporting groups
36198|NCT02198833|B2|Baseline|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36199|NCT02198833|B1|Baseline|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36200|NCT02198833|P2|Participant Flow|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36201|NCT02198833|P1|Participant Flow|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36202|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36203|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36204|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36205|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36206|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36207|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36208|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36209|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36210|NCT02198833|E2|Reported Event|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36211|NCT02198833|E1|Reported Event|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Urine Culture: Obtain urine culture every third day
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture
Scanning Electron Microscopy: Houston Site Only
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
36212|NCT02198430|B3|Baseline|Total|Total of all reporting groups
36213|NCT02198430|B2|Baseline|Control Group|Children without hemophilia
36214|NCT02198430|B1|Baseline|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
36215|NCT02198430|P2|Participant Flow|Control Group|Children without hemophilia
36216|NCT02198430|P1|Participant Flow|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
36217|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
36218|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
36219|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
36220|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
36221|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
36222|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
36223|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
36224|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
36225|NCT02198430|E2|Reported Event|Control Group|Children without hemophilia
36231|NCT02198235|P3|Participant Flow|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36232|NCT02198235|P2|Participant Flow|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36233|NCT02198235|P1|Participant Flow|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)
Dexamethasone"
36234|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36235|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36236|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)
Dexamethasone"
36237|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36238|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36239|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)
Dexamethasone"
36240|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36241|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36242|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)
Dexamethasone"
36243|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36244|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36245|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)
Dexamethasone"
36246|NCT02198235|E3|Reported Event|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36247|NCT02198235|E2|Reported Event|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine"
36248|NCT02198235|E1|Reported Event|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)
Dexamethasone"
36249|NCT02198040|B4|Baseline|Total|Total of all reporting groups
36250|NCT02198040|B3|Baseline|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
36251|NCT02198040|B2|Baseline|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
36252|NCT02198040|B1|Baseline|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each.
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.
10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
36253|NCT02198040|P3|Participant Flow|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
36254|NCT02198040|P2|Participant Flow|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
36255|NCT02198040|P1|Participant Flow|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.
10"
36256|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
36428|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36257|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
36258|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
36259|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
36260|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
36261|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
36262|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
36263|NCT02198040|O2|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
36264|NCT02198040|O1|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist.
10"
36265|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
36266|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
36303|NCT02197273|B2|Baseline|Liposomal Bupivacaine|"THA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue
TKA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue
TSA:
All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
Liposomal bupivacaine
Standard of care analgesia"
36429|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36430|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
57318|NCT02033200|O1|Outcome|Active|Stendra 200 mg
36267|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
36268|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
36269|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
36270|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
36271|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
36272|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
36273|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
36274|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
36275|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
36276|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
36277|NCT02198040|E3|Reported Event|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
36334|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36422|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36423|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36278|NCT02198040|E2|Reported Event|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
36279|NCT02198040|E1|Reported Event|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
36280|NCT02197806|B5|Baseline|Total|Total of all reporting groups
36281|NCT02197806|B4|Baseline|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
36282|NCT02197806|B3|Baseline|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36283|NCT02197806|B2|Baseline|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36284|NCT02197806|B1|Baseline|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36285|NCT02197806|P4|Participant Flow|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
36286|NCT02197806|P3|Participant Flow|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36287|NCT02197806|P2|Participant Flow|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36288|NCT02197806|P1|Participant Flow|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36289|NCT02197806|O4|Outcome|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
36290|NCT02197806|O3|Outcome|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36291|NCT02197806|O2|Outcome|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36292|NCT02197806|O1|Outcome|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36293|NCT02197806|E4|Reported Event|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
36294|NCT02197806|E3|Reported Event|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36295|NCT02197806|E2|Reported Event|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36296|NCT02197806|E1|Reported Event|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
36297|NCT02197455|B1|Baseline|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
36298|NCT02197455|P1|Participant Flow|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
36299|NCT02197455|O1|Outcome|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
36300|NCT02197455|O1|Outcome|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
36301|NCT02197455|E1|Reported Event|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
36302|NCT02197273|B3|Baseline|Total|Total of all reporting groups
36356|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36304|NCT02197273|B1|Baseline|Standard of Care Analgesia|"THA:
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine
Injection into capsular tissue after placement of the acetabular component:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TKA:
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc
Injection into posterior capsule of the knee:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TSA:
All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.
Standard of care analgesia"
36305|NCT02197273|P2|Participant Flow|Liposomal Bupivacaine|"THA:
36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.
Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue
TKA:
34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.
Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue
TSA:
34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
Liposomal bupivacaine
Standard of care analgesia"
36306|NCT02197273|P1|Participant Flow|Standard of Care Analgesia|"THA:
33 patients received a spinal anesthetic using Fentanyl and Bupivacaine
Injection into capsular tissue after placement of the acetabular component:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TKA:
39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc
Injection into posterior capsule of the knee:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TSA:
35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.
Standard of care analgesia"
36307|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:
36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.
Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue
TKA:
34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.
Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue
TSA:
34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
Liposomal bupivacaine
Standard of care analgesia"
36308|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:
33 patients received a spinal anesthetic using Fentanyl and Bupivacaine
Injection into capsular tissue after placement of the acetabular component:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TKA:
39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc
Injection into posterior capsule of the knee:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TSA:
35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.
Standard of care analgesia"
36309|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:
36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.
Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue
TKA:
34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.
Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue
TSA:
34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
Liposomal bupivacaine
Standard of care analgesia"
36310|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:
33 patients received a spinal anesthetic using Fentanyl and Bupivacaine
Injection into capsular tissue after placement of the acetabular component:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TKA:
39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc
Injection into posterior capsule of the knee:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TSA:
35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.
Standard of care analgesia"
36311|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:
36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.
Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue
TKA:
34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.
Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue
TSA:
34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
Liposomal bupivacaine
Standard of care analgesia"
36312|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:
33 patients received a spinal anesthetic using Fentanyl and Bupivacaine
Injection into capsular tissue after placement of the acetabular component:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TKA:
39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc
Injection into posterior capsule of the knee:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TSA:
35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.
Standard of care analgesia"
36313|NCT02197273|E2|Reported Event|Liposomal Bupivacaine|"THA:
36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.
Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue
TKA:
33 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.
Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue
TSA:
34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
Liposomal bupivacaine
Standard of care analgesia"
36424|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36425|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36314|NCT02197273|E1|Reported Event|Standard of Care Analgesia|"THA:
33 patients received a spinal anesthetic using Fentanyl and Bupivacaine
Injection into capsular tissue after placement of the acetabular component:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TKA:
39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc
Injection into posterior capsule of the knee:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TSA:
35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.
Standard of care analgesia"
36315|NCT02197247|B1|Baseline|AZD9291 Alone, AZD9291 + Rifampicin, AZD9291 Alone|Sequential treatments of AZD9291 alone (Period 1), followed by AZD9291 + rifampicin (Period 2), followed by AZD9291 alone (Period 3) (Part A).
36316|NCT02197247|P1|Participant Flow|AZD9291 Alone, AZD9291 + Rifampicin, AZD9291 Alone|Sequential treatments of AZD9291 alone (Period 1), followed by AZD9291 + rifampicin (Period 2), followed by AZD9291 alone (Period 3) (Part A).
36317|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
36318|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36319|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36320|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
36321|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36322|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36323|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36324|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
36325|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36326|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36327|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36328|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
36329|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36330|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36331|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36332|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
36333|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36357|NCT02197247|E1|Reported Event|AZD9291 Alone, AZD9291 + Rifampicin, AZD9291 Alone|Sequential treatments of AZD9291 alone (Period 1), followed by AZD9291 + rifampicin (Period 2), followed by AZD9291 alone (Period 3) (Part A).
36335|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36336|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
36337|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36338|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36339|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
36340|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36341|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36342|NCT02197247|O2|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
36343|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36344|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36345|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
36346|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36347|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36348|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
36349|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36350|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36351|NCT02197247|O2|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
36352|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36353|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36354|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
36355|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
36418|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36426|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36358|NCT02197234|B1|Baseline|Simvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291. Each patient received 80 mg oral doses of AZD9291 tablets once daily for 30 days (Days 3 to 32) and single 40 mg oral doses of simvastatin on Day 1 and Day 31.
In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
36359|NCT02197234|P1|Participant Flow|Simvastatin and AZD9291 (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291. Each patient received 80 mg oral doses of AZD9291 tablets once daily for 30 days (Days 3 to 32) and single 40 mg oral doses of simvastatin on Day 1 and Day 31.
In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
36360|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
36361|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
36362|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
36363|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
36364|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
36365|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
36366|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
36367|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
36368|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
36369|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
36370|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
36371|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
36372|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
36373|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
36374|NCT02197234|E3|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
36375|NCT02197234|E2|Reported Event|Part A Safety Population|In Part A of the study, each patient received 80 mg oral doses of AZD9291 tablets once daily for 30 days (Days 3 to 32) and single 40 mg oral doses of simvastatin on Day 1 and Day 31.
36376|NCT02197234|E1|Reported Event|Overall Safety Population|Parts A and B of the study combined.
36377|NCT02197065|B3|Baseline|Total|Total of all reporting groups
36378|NCT02197065|B2|Baseline|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Placebo"
36379|NCT02197065|B1|Baseline|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
36380|NCT02197065|P2|Participant Flow|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Placebo"
36381|NCT02197065|P1|Participant Flow|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
36382|NCT02197065|O2|Outcome|Sugar Pill|Sugar pill (placebo) daily starting 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
36383|NCT02197065|O1|Outcome|Atorvastatin|Atorvastatin 40mg daily starting 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
36384|NCT02197065|O2|Outcome|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Placebo"
36385|NCT02197065|O1|Outcome|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
36386|NCT02197065|O1|Outcome|All Patients|All patients in the study
36387|NCT02197065|E2|Reported Event|Sugar Pill|"Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Placebo"
36388|NCT02197065|E1|Reported Event|Atorvastatin|"Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45"
36389|NCT02196766|B1|Baseline|Bioclean First Care EX / Aosept Clearcare / Comfil|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
36390|NCT02196766|P2|Participant Flow|Aosept Clearcare Combo First,Then Bioclean First Care EX Combo|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
36391|NCT02196766|P1|Participant Flow|Bioclean First Care EX Combo, Then Aosept Clearcare Combo|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
36419|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36420|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36421|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36392|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36393|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36394|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36395|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36396|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36397|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36398|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36399|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36400|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36401|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36402|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36403|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36404|NCT02196766|E2|Reported Event|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36405|NCT02196766|E1|Reported Event|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
36406|NCT02196714|B1|Baseline|All Subjects|Analysis Set: All Subjects Randomized
36407|NCT02196714|P4|Participant Flow|Received GP MDI 14.4 μg|Received GP MDI 14.4 μg
36408|NCT02196714|P3|Participant Flow|Received GP MDI 28.8 μg|Glycopyrronium (GP) Metered Dose Inhaler (MDI) 28.8 μg
36409|NCT02196714|P2|Participant Flow|Received GFF MDI 14.4/9.6 μg|Received GFF MDI 14.4/9.6 μg
36410|NCT02196714|P1|Participant Flow|Received GFF MDI 28.8/9.6 μg|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 μg
36411|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36412|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36413|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36414|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36415|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36416|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36417|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36431|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36432|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36433|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36434|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36435|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36436|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36437|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36438|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36439|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36440|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36441|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36442|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36443|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36444|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36445|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36446|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36447|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36448|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36449|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36450|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36451|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36452|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36453|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36454|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36455|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36456|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36457|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36458|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36459|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36460|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36461|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36462|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36463|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36464|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36465|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36466|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36467|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36468|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36469|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36470|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36471|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36472|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36473|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
36474|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36475|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36476|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36477|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36478|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36479|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
36480|NCT02196714|O3|Outcome|GP MDI 28.8 µg|GP MDI 28.8 µg
36481|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36482|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36483|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36484|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36485|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
36486|NCT02196714|O3|Outcome|GP MDI 28.8 µg|GP MDI 28.8 µg
36487|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36488|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36489|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36490|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36491|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
36492|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36493|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36494|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36495|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36496|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36497|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
36498|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36500|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36501|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36502|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36503|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
36504|NCT02196714|O3|Outcome|GP MDI 28.8 µg|GP MDI 28.8 µg
36505|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36506|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36507|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36508|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36509|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
36510|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36511|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36512|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36513|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36514|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36515|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
36516|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36517|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36518|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36519|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36520|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36521|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
36522|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
36523|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36524|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36525|NCT02196714|E4|Reported Event|GP MDI 14.4 µg|GP MDI 14.4 µg
36526|NCT02196714|E3|Reported Event|GP MDI 28.8 ug|GP MDI 28.8 ug
36527|NCT02196714|E2|Reported Event|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
36528|NCT02196714|E1|Reported Event|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
36529|NCT02196675|B4|Baseline|Total|Total of all reporting groups
36530|NCT02196675|B3|Baseline|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
36531|NCT02196675|B2|Baseline|Lobectomy|Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
36532|NCT02196675|B1|Baseline|Wedge Resection|Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
36533|NCT02196675|P3|Participant Flow|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
36534|NCT02196675|P2|Participant Flow|Lobectomy|Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
36535|NCT02196675|P1|Participant Flow|Wedge Resection|Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
36536|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
36537|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
36538|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
36539|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
36540|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
36541|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
36542|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
36543|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
36544|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
36545|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
36546|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
36547|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
36548|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
36549|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
36550|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
36551|NCT02196675|E3|Reported Event|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
36552|NCT02196675|E2|Reported Event|Lobectomy|Subjects undergoing VATS lobectomy
36553|NCT02196675|E1|Reported Event|Wedge Resection|Subjects undergoing VATS wedge resection
36554|NCT02196259|B4|Baseline|Total|Total of all reporting groups
36555|NCT02196259|B3|Baseline|Depression|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
36556|NCT02196259|B2|Baseline|Initial Hospital|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
36578|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
WEE1 Inhibitor AZD1775: Given PO"
57319|NCT02033200|E2|Reported Event|Placebo|placebo
36557|NCT02196259|B1|Baseline|Initial MRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
36558|NCT02196259|P3|Participant Flow|Depresssion|
36559|NCT02196259|P2|Participant Flow|Hospital|
36560|NCT02196259|P1|Participant Flow|Initial MRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
36561|NCT02196259|O2|Outcome|Depression|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
36562|NCT02196259|O1|Outcome|Initial MRI|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
36563|NCT02196259|E3|Reported Event|Depression|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
36564|NCT02196259|E2|Reported Event|Hospital|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
36565|NCT02196259|E1|Reported Event|Initial fMRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
36566|NCT02196168|B3|Baseline|Total|Total of all reporting groups
36567|NCT02196168|B2|Baseline|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
36568|NCT02196168|B1|Baseline|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
WEE1 Inhibitor AZD1775: Given PO"
36569|NCT02196168|P2|Participant Flow|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
36570|NCT02196168|P1|Participant Flow|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
WEE1 Inhibitor AZD1775: Given PO"
36571|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
36572|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
WEE1 Inhibitor AZD1775: Given PO"
36573|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
36574|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
WEE1 Inhibitor AZD1775: Given PO"
36575|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
36576|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
WEE1 Inhibitor AZD1775: Given PO"
36577|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
53770|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
36579|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
36580|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
WEE1 Inhibitor AZD1775: Given PO"
36581|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
36582|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
WEE1 Inhibitor AZD1775: Given PO"
36583|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
36584|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
WEE1 Inhibitor AZD1775: Given PO"
36585|NCT02196168|E2|Reported Event|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
36586|NCT02196168|E1|Reported Event|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
WEE1 Inhibitor AZD1775: Given PO"
36587|NCT02196077|B1|Baseline|Subjects|
36588|NCT02196077|P1|Participant Flow|Subjects|
36589|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
36590|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
36591|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
36592|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
36593|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
36594|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
36595|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
36596|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
36597|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
36598|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
36599|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
36600|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
36601|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
36602|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
36603|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
36604|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
36605|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
36606|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
36607|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
36608|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
36609|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
36610|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
36611|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
36612|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
36613|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
36614|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
36615|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
36616|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
36617|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
36618|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
36619|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
36620|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
36621|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
36622|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
36623|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
36624|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
36625|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
36626|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
36627|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
36628|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
36629|NCT02196077|E5|Reported Event|FF MDI 9.6 ug|FF MDI 9.6 ug
36630|NCT02196077|E4|Reported Event|BD MDI 320 ug|BD MDI 320 ug
36631|NCT02196077|E3|Reported Event|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
36632|NCT02196077|E2|Reported Event|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
36633|NCT02196077|E1|Reported Event|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
36634|NCT02195713|B3|Baseline|Total|Total of all reporting groups
36635|NCT02195713|B2|Baseline|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
36636|NCT02195713|B1|Baseline|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.
Accuryn: Accuryn is a novel electronic urine output monitor"
36637|NCT02195713|P2|Participant Flow|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
37326|NCT02190604|E6|Reported Event|Part 1 QBW251 500mg|Part 1 QBW251 500mg
36638|NCT02195713|P1|Participant Flow|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.
Accuryn: Accuryn is a novel electronic urine output monitor"
36639|NCT02195713|O2|Outcome|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
36640|NCT02195713|O1|Outcome|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.
Accuryn: Accuryn is a novel electronic urine output monitor"
36641|NCT02195713|E2|Reported Event|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
36642|NCT02195713|E1|Reported Event|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.
Accuryn: Accuryn is a novel electronic urine output monitor"
36643|NCT02195687|B3|Baseline|Total|Total of all reporting groups
36644|NCT02195687|B2|Baseline|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
36645|NCT02195687|B1|Baseline|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
36646|NCT02195687|P2|Participant Flow|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
36647|NCT02195687|P1|Participant Flow|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
36648|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
36649|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
36650|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
36651|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
36652|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
36653|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
36654|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
36655|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
36656|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
36657|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
36658|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
36659|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
36660|NCT02195687|E2|Reported Event|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
36661|NCT02195687|E1|Reported Event|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
36662|NCT02195583|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics
36663|NCT02195583|P1|Participant Flow|Overall Participants|"Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 seconds (sec) to create dentifrice slurry. Then swished the slurry around the palatal appliance for 1 minute (min) and 35 sec. Next, they expectorated the slurry, rinsed with 15 milliliter (mL) of tap water for 10 sec and expectorated. There was a 2 day washout period before each treatment period when participants used a non-fluoridated dentifrice.
Sodium fluoride (1426 ppm):Non-zinc, 1426ppm fluoride as sodium fluoride in silica base
Sodium fluoride (1150 ppm):Non-zinc, 1150ppm fluoride as sodium fluoride in silica base
Sodium fluoride (250 ppm):Non-zinc, 250ppm fluoride as sodium fluoride in silica base
Sodium fluoride (1426 ppm) + zinc base A:Zinc base A, 1426ppm fluoride as sodium fluoride in silica base
Sodium fluoride (1426 ppm) + zinc base B:Zinc base B, 1426ppm fluoride as sodium fluoride in silica base
Sodium fluoride (0 ppm):Non-zinc, 0ppm fluoride in silica base"
36664|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Sodium fluoride (0 ppm) Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36665|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36666|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36791|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
36794|NCT02193828|E3|Reported Event|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
57320|NCT02033200|E1|Reported Event|Active|Stendra 200 mg
36667|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36668|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36669|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36670|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36671|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36672|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36673|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36674|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36675|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36676|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36677|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36678|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36715|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
36792|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
53771|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
36679|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36680|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36681|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36682|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36683|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36684|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36685|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36686|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36687|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36688|NCT02195583|E6|Reported Event|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36689|NCT02195583|E5|Reported Event|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36690|NCT02195583|E4|Reported Event|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36716|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
36793|NCT02193828|E4|Reported Event|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
36691|NCT02195583|E3|Reported Event|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36692|NCT02195583|E2|Reported Event|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36693|NCT02195583|E1|Reported Event|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
36694|NCT02195414|B1|Baseline|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
36695|NCT02195414|P1|Participant Flow|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
36696|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
36697|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
36698|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
36699|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
36700|NCT02195414|E1|Reported Event|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
36701|NCT02194621|B4|Baseline|Total|Total of all reporting groups
36702|NCT02194621|B3|Baseline|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
36703|NCT02194621|B2|Baseline|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
36704|NCT02194621|B1|Baseline|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
36705|NCT02194621|P3|Participant Flow|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
36706|NCT02194621|P2|Participant Flow|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
36707|NCT02194621|P1|Participant Flow|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
36708|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
36709|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
36710|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
36711|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
36712|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
36713|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
36714|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
36717|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
36718|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
36719|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
36720|NCT02194621|E3|Reported Event|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
36721|NCT02194621|E2|Reported Event|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
36722|NCT02194621|E1|Reported Event|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
36723|NCT02194088|B3|Baseline|Total|Total of all reporting groups
36724|NCT02194088|B2|Baseline|Placebo|"Placebo capsules will be delivered in same number as the medication
Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
36725|NCT02194088|B1|Baseline|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose
Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
36726|NCT02194088|P2|Participant Flow|Placebo|"Placebo capsules will be delivered in same number as the medication
Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
36727|NCT02194088|P1|Participant Flow|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose
Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
36728|NCT02194088|O2|Outcome|Placebo|"Placebo capsules will be delivered in same number as the medication
Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
36729|NCT02194088|O1|Outcome|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose
Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
36730|NCT02194088|O2|Outcome|Placebo|
36731|NCT02194088|O1|Outcome|Pain Medication:Diclofenac an Atropine|
36732|NCT02194088|O2|Outcome|Placebo|"Placebo capsules will be delivered in same number as the medication
Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
36733|NCT02194088|O1|Outcome|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose
Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
36734|NCT02194088|E2|Reported Event|Placebo|"Placebo capsules will be delivered in same number as the medication
Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
36735|NCT02194088|E1|Reported Event|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose
Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
36736|NCT02194062|B4|Baseline|Total|Total of all reporting groups
36737|NCT02194062|B3|Baseline|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
36738|NCT02194062|B2|Baseline|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
36739|NCT02194062|B1|Baseline|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
36740|NCT02194062|P3|Participant Flow|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
36741|NCT02194062|P2|Participant Flow|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
36742|NCT02194062|P1|Participant Flow|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
36743|NCT02194062|O3|Outcome|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
36789|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
36790|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
36744|NCT02194062|O2|Outcome|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
36745|NCT02194062|O1|Outcome|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
36746|NCT02194062|O3|Outcome|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
36747|NCT02194062|O2|Outcome|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
36748|NCT02194062|O1|Outcome|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
36749|NCT02194062|E3|Reported Event|Budesonide Head Forward|budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
36750|NCT02194062|E2|Reported Event|Budesonide Respule in Head Upright|Budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
36751|NCT02194062|E1|Reported Event|Fluticasone Group|Fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
36752|NCT02193828|B5|Baseline|Total|Total of all reporting groups
36753|NCT02193828|B4|Baseline|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
36754|NCT02193828|B3|Baseline|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
36755|NCT02193828|B2|Baseline|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
36756|NCT02193828|B1|Baseline|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
36757|NCT02193828|P4|Participant Flow|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
36758|NCT02193828|P3|Participant Flow|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
36759|NCT02193828|P2|Participant Flow|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
36760|NCT02193828|P1|Participant Flow|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
36761|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
36762|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
36763|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
36764|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
36765|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
36766|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
36767|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
36768|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
36769|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
36770|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
36771|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
36772|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
36773|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
36774|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
36775|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
36776|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
36777|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
36778|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
36779|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
36780|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
36781|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
36782|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
36783|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
36784|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
36785|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
36786|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
36787|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
36788|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
36795|NCT02193828|E2|Reported Event|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
36796|NCT02193828|E1|Reported Event|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
36797|NCT02193815|B1|Baseline|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
36798|NCT02193815|P1|Participant Flow|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
36799|NCT02193815|O1|Outcome|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
36800|NCT02193815|O1|Outcome|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
36801|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
36802|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
36803|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
36804|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
36805|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
36806|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
36807|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
36808|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
36809|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
36810|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
36811|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
36812|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
36813|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
36814|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
36815|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
36816|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
36817|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
36818|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
36819|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
36820|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
36821|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
36822|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
36823|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
36824|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
36825|NCT02193815|O2|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
36826|NCT02193815|O1|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
36827|NCT02193815|O2|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
36828|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
36829|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.
36830|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
36938|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36941|NCT02193087|O4|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
69901|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
36831|NCT02193815|E1|Reported Event|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
36832|NCT02193178|B1|Baseline|Overall Baseline Characteristics|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
36833|NCT02193178|P1|Participant Flow|Overall Participants|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
36834|NCT02193178|O2|Outcome|2 Weeks|
36835|NCT02193178|O1|Outcome|Baseline|
36836|NCT02193178|O2|Outcome|2 Weeks|
36837|NCT02193178|O1|Outcome|Baseline|
36838|NCT02193178|O2|Outcome|2 Weeks|
36839|NCT02193178|O1|Outcome|Baseline|
36840|NCT02193178|O2|Outcome|2 Weeks|
36841|NCT02193178|O1|Outcome|Baseline|
36842|NCT02193178|O2|Outcome|2 Weeks|
36843|NCT02193178|O1|Outcome|Baseline|
36844|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
36845|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
36846|NCT02193178|O1|Outcome|Habitual Lenses|
36847|NCT02193178|O4|Outcome|Conjunctival Indentation (2 Weeks)|
36848|NCT02193178|O3|Outcome|Conjunctival Staining (2 Weeks)|
36849|NCT02193178|O2|Outcome|Conjunctival Indentation (Baseline)|
36850|NCT02193178|O1|Outcome|Conjunctival Staining (Baseline)|
36851|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
36852|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
36853|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
36854|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
36855|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
36856|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
36857|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
36858|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
36859|NCT02193178|O1|Outcome|Habitual Lenses|
36860|NCT02193178|O3|Outcome|2 Weeks|
36861|NCT02193178|O2|Outcome|Baseline|
36862|NCT02193178|O1|Outcome|Habitual Lenses|
36863|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
36864|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
36865|NCT02193178|O1|Outcome|Habitual Lenses|
36866|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
36867|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
36868|NCT02193178|O1|Outcome|Habitual Lenses|
36869|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
36870|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
36871|NCT02193178|O1|Outcome|Habitual Lenses|
36872|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
36873|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
36874|NCT02193178|O1|Outcome|Habitual Lenses|
36875|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
36876|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
36877|NCT02193178|O1|Outcome|Habitual Lenses|
36878|NCT02193178|E1|Reported Event|Comfilcon A Toric XR MTO|"Participants are habitual contact lens wearers and will be fitted with comfilcon A Toric XR MTO lenses.
comfilcon A Toric XR (MTO) contact lenses"
36879|NCT02193165|B4|Baseline|Total|Total of all reporting groups
36880|NCT02193165|B3|Baseline|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
36881|NCT02193165|B2|Baseline|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
36882|NCT02193165|B1|Baseline|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
36883|NCT02193165|P3|Participant Flow|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
36884|NCT02193165|P2|Participant Flow|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
36885|NCT02193165|P1|Participant Flow|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
36886|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
36940|NCT02193087|O5|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
54558|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
36887|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
36888|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
36889|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
36890|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
36891|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
36892|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
36893|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
36894|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
36895|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
36896|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
36897|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
36898|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
36899|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
36900|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
36901|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
36902|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
36903|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
36939|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
36904|NCT02193165|E3|Reported Event|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
36905|NCT02193165|E2|Reported Event|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
36906|NCT02193165|E1|Reported Event|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
36907|NCT02193087|B5|Baseline|Total|Total of all reporting groups
36908|NCT02193087|B4|Baseline|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36909|NCT02193087|B3|Baseline|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
36910|NCT02193087|B2|Baseline|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36911|NCT02193087|B1|Baseline|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
36912|NCT02193087|P4|Participant Flow|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36913|NCT02193087|P3|Participant Flow|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
36914|NCT02193087|P2|Participant Flow|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36915|NCT02193087|P1|Participant Flow|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
36916|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36917|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
36918|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36919|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
36920|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36921|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
36922|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36923|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
36924|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36925|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
36926|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36927|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
36928|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36929|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
36930|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36931|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
36932|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36933|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
36934|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36935|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
36936|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36937|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
37320|NCT02190604|E12|Reported Event|Part 2 QBW251 400mg|Part 2 QBW251 400mg
36942|NCT02193087|O3|Outcome|Group A and Group B Combined|"Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
36943|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36944|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
36945|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36946|NCT02193087|O1|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36947|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36948|NCT02193087|O1|Outcome|Group A + Group B Combined|"Group A: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
36949|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36950|NCT02193087|O1|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36951|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36952|NCT02193087|O1|Outcome|Group A + Group B Combined|"Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
36953|NCT02193087|E4|Reported Event|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
36954|NCT02193087|E3|Reported Event|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
36955|NCT02193087|E2|Reported Event|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
36956|NCT02193087|E1|Reported Event|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
36957|NCT02193074|B3|Baseline|Total|Total of all reporting groups
36958|NCT02193074|B2|Baseline|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36959|NCT02193074|B1|Baseline|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36960|NCT02193074|P2|Participant Flow|Nusinersen|Nusinersen (2.4 mg/mL) administered as an intrathecal (IT) lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36961|NCT02193074|P1|Participant Flow|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36962|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36963|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36964|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36965|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36966|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36967|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36968|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36969|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36970|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36971|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36972|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36973|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36974|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36975|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36976|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36977|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36978|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36979|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36980|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36981|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
54559|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
37325|NCT02190604|E7|Reported Event|Part 1 QBW251 500mg (Fed)|Part 1 QBW251 500mg (fed)
36982|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36983|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36984|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36985|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36986|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36987|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36988|NCT02193074|O2|Outcome|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36989|NCT02193074|O1|Outcome|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36990|NCT02193074|E2|Reported Event|Nusinersen|Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
36991|NCT02193074|E1|Reported Event|Control|Sham procedure administered on Study Days 1, 15, 29, 64, 183, and 302.
36992|NCT02192879|B4|Baseline|Total|Total of all reporting groups
36993|NCT02192879|B3|Baseline|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
36994|NCT02192879|B2|Baseline|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
36995|NCT02192879|B1|Baseline|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
36996|NCT02192879|P3|Participant Flow|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
36997|NCT02192879|P2|Participant Flow|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
36998|NCT02192879|P1|Participant Flow|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
36999|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
37000|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
37001|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
37002|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
37003|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
37086|NCT02191046|B1|Baseline|Syringe 20 ml|"nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge
syringe 20 ml: nasal irrigation twice daily for 2 weeks period"
37321|NCT02190604|E11|Reported Event|Part 2 QBW251 150mg|Part 2 QBW251 150mg
37322|NCT02190604|E10|Reported Event|Part 2 Placebo|Part 2 Placebo
37004|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
37005|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
37006|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
37007|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
37008|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
37009|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
37010|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
37011|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
37012|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
37013|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
37014|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
37015|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
37016|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
37017|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
37032|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
37018|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
37019|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
37020|NCT02192879|E3|Reported Event|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
37021|NCT02192879|E2|Reported Event|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
37022|NCT02192879|E1|Reported Event|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
37023|NCT02192814|B1|Baseline|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
37024|NCT02192814|P1|Participant Flow|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
37025|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
37026|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
37027|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
37028|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
37029|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
37030|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
37031|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
37083|NCT02191865|E1|Reported Event|Child Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
37033|NCT02192814|E1|Reported Event|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was be the same as the subject's current daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
37034|NCT02192684|B3|Baseline|Total|Total of all reporting groups
37035|NCT02192684|B2|Baseline|Placebo|"Placebo, one pill daily
placebo: Compare with pioglitazone"
37036|NCT02192684|B1|Baseline|Pioglitazone|"pioglitazone 45 mg, oral, daily
Pioglitazone: 45 mg daily Insulin sensitizing"
37037|NCT02192684|P2|Participant Flow|Placebo|"Placebo, one pill daily
placebo: Compare with pioglitazone"
37038|NCT02192684|P1|Participant Flow|Pioglitazone|"pioglitazone 45 mg, oral, daily
Pioglitazone: 45 mg daily Insulin sensitizing"
37039|NCT02192684|O2|Outcome|Placebo|"Placebo, one pill daily
placebo: Compare with pioglitazone"
37040|NCT02192684|O1|Outcome|Pioglitazone|"pioglitazone 45 mg, oral, daily
Pioglitazone: 45 mg daily Insulin sensitizing"
37041|NCT02192684|E2|Reported Event|Placebo|"Placebo, one pill daily
placebo: Compare with pioglitazone"
37042|NCT02192684|E1|Reported Event|Pioglitazone|"pioglitazone 45 mg, oral, daily
Pioglitazone: 45 mg daily Insulin sensitizing"
37043|NCT02192164|B1|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment based on treating physician’s discretion as per Summary of Product Characteristics (SmPC) were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37044|NCT02192164|P1|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment based on treating physician’s discretion as per Summary of Product Characteristics (SmPC) were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37045|NCT02192164|O1|Outcome|Etanercept: Former Smoker + Smoker|Participants who were smokers during the study and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37046|NCT02192164|O1|Outcome|Etanercept: Former Smoker + Smoker|Participants who were smokers during the study and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37047|NCT02192164|O2|Outcome|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37048|NCT02192164|O1|Outcome|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37049|NCT02192164|O2|Outcome|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37050|NCT02192164|O1|Outcome|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37051|NCT02192164|O2|Outcome|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37052|NCT02192164|O1|Outcome|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37053|NCT02192164|O2|Outcome|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37054|NCT02192164|O1|Outcome|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37055|NCT02192164|O2|Outcome|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37084|NCT02191046|B3|Baseline|Total|Total of all reporting groups
37085|NCT02191046|B2|Baseline|Squeezable Bottle|"nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge
squeezable bottle: nasal irrigation twice daily for 2 weeks period"
37056|NCT02192164|O1|Outcome|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37057|NCT02192164|E2|Reported Event|Etanercept: Smokers|Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37058|NCT02192164|E1|Reported Event|Etanercept: Non Smokers|Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
37059|NCT02191865|B4|Baseline|Total|Total of all reporting groups
37060|NCT02191865|B3|Baseline|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
37061|NCT02191865|B2|Baseline|Child Pugh B|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
37062|NCT02191865|B1|Baseline|Child Pugh A|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
37063|NCT02191865|P3|Participant Flow|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
37064|NCT02191865|P2|Participant Flow|Child Pugh B|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
37065|NCT02191865|P1|Participant Flow|Child Pugh A|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
37066|NCT02191865|O3|Outcome|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
37067|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
37068|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
37069|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
37070|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
37071|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
37072|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
37073|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
37074|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
37075|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
37076|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
37077|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
37078|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
37079|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
37080|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
37081|NCT02191865|E3|Reported Event|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
37082|NCT02191865|E2|Reported Event|Child Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
37087|NCT02191046|P2|Participant Flow|Squeezable Bottle|"nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge
squeezable bottle: nasal irrigation twice daily for 2 weeks period"
37088|NCT02191046|P1|Participant Flow|Syringe 20 ml|"nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge
syringe 20 ml: nasal irrigation twice daily for 2 weeks period"
37089|NCT02191046|O2|Outcome|Squeezable Bottle|improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect and significant improve in 5-s score and satisfaction when compare to syringe group
37090|NCT02191046|O1|Outcome|Syringe 20 ml|improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect
37091|NCT02191046|E2|Reported Event|Squeezable Bottle|record adverse event at baseline and daily adverse events until 2 weeks after treatment
37092|NCT02191046|E1|Reported Event|Syringe 20 ml|record adverse event at baseline and daily adverse events until 2 weeks after treatment
37093|NCT02191033|B3|Baseline|Total|Total of all reporting groups
37094|NCT02191033|B2|Baseline|Standard of Care|"Smoking counseling, nicotine patch
Smoking counseling
Nicotine patch"
37095|NCT02191033|B1|Baseline|Text Messaging|"Smoking counseling, nicotine patch, text messaging
Smoking counseling
Text messaging
Nicotine patch"
37096|NCT02191033|P2|Participant Flow|Standard of Care|"Smoking counseling, nicotine patch
Smoking counseling
Nicotine patch"
37097|NCT02191033|P1|Participant Flow|Text Messaging|"Smoking counseling, nicotine patch, text messaging
Smoking counseling
Nicotine patch
Text messaging"
37098|NCT02191033|O2|Outcome|Standard of Care|"Smoking counseling, nicotine patch
Smoking counseling
Nicotine patch"
37099|NCT02191033|O1|Outcome|Text Messaging|"Smoking counseling, nicotine patch, text messaging
Smoking counseling
Nicotine patch
Text messaging"
37100|NCT02191033|O2|Outcome|Standard of Care|"Smoking counseling, nicotine patch
Smoking counseling
Nicotine patch"
37101|NCT02191033|O1|Outcome|Text Messaging|"Smoking counseling, nicotine patch, text messaging
Smoking counseling
Nicotine patch
Text messaging"
37102|NCT02191033|O2|Outcome|Standard of Care|"Smoking counseling, nicotine patch
Smoking counseling
Nicotine patch"
37103|NCT02191033|O1|Outcome|Text Messaging|"Smoking counseling, nicotine patch, text messaging
Smoking counseling
Nicotine patch
Text messaging"
37104|NCT02191033|E2|Reported Event|Standard of Care|"Smoking counseling, nicotine patch
Smoking counseling
Nicotine patch"
37105|NCT02191033|E1|Reported Event|Text Messaging|"Smoking counseling, nicotine patch, text messaging
Smoking counseling
Nicotine patch
Text messaging"
37106|NCT02190604|B20|Baseline|Total|Total of all reporting groups
37107|NCT02190604|B19|Baseline|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37108|NCT02190604|B18|Baseline|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37109|NCT02190604|B17|Baseline|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37110|NCT02190604|B16|Baseline|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37111|NCT02190604|B15|Baseline|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37112|NCT02190604|B14|Baseline|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37113|NCT02190604|B13|Baseline|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37114|NCT02190604|B12|Baseline|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37115|NCT02190604|B11|Baseline|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37116|NCT02190604|B10|Baseline|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37117|NCT02190604|B9|Baseline|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37118|NCT02190604|B8|Baseline|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37119|NCT02190604|B7|Baseline|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37120|NCT02190604|B6|Baseline|Part 1 Cohort 6: QBW251 (Fastin / Fed), Same Subjects|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37323|NCT02190604|E9|Reported Event|Part 1 QBW251 1000mg|Part 1 QBW251 1000mg
37121|NCT02190604|B5|Baseline|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37122|NCT02190604|B4|Baseline|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37123|NCT02190604|B3|Baseline|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37124|NCT02190604|B2|Baseline|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37125|NCT02190604|B1|Baseline|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37126|NCT02190604|P19|Participant Flow|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37127|NCT02190604|P18|Participant Flow|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37128|NCT02190604|P17|Participant Flow|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37129|NCT02190604|P16|Participant Flow|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37130|NCT02190604|P15|Participant Flow|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37131|NCT02190604|P14|Participant Flow|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37132|NCT02190604|P13|Participant Flow|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37133|NCT02190604|P12|Participant Flow|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37134|NCT02190604|P11|Participant Flow|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37135|NCT02190604|P10|Participant Flow|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37136|NCT02190604|P9|Participant Flow|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37137|NCT02190604|P8|Participant Flow|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37138|NCT02190604|P7|Participant Flow|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37139|NCT02190604|P6|Participant Flow|Part 1 Cohort 6: QBW251 (Fasting/Fed), Same Subjects|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37140|NCT02190604|P5|Participant Flow|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37141|NCT02190604|P4|Participant Flow|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37142|NCT02190604|P3|Participant Flow|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37200|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37324|NCT02190604|E8|Reported Event|Part 1 QBW251 750mg|Part 1 QBW251 750mg
37143|NCT02190604|P2|Participant Flow|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37144|NCT02190604|P1|Participant Flow|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37145|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37146|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37147|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37148|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37149|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37150|NCT02190604|O6|Outcome|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37151|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37152|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37153|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37154|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37155|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37156|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37157|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37158|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37159|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37160|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37161|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37162|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37163|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37164|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37165|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37166|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37167|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37168|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37313|NCT02190604|E19|Reported Event|Part 3 QBW251 450mg BID C3|Part 3 QBW251 450mg BID C3
37169|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37170|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37171|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37172|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37173|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37174|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37175|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37176|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37177|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37178|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37179|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37180|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37181|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37182|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37183|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37184|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37185|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37186|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37187|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37188|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37189|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37190|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37191|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37192|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37193|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37194|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37195|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37196|NCT02190604|O6|Outcome|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37197|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37198|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37199|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37201|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37202|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37203|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37204|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37205|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37206|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37207|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37208|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37209|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37210|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37211|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37212|NCT02190604|O5|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37213|NCT02190604|O4|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37214|NCT02190604|O3|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37215|NCT02190604|O2|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37216|NCT02190604|O1|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37217|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37218|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37219|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37220|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37221|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37222|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37223|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37224|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37225|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37226|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37227|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37228|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37229|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37230|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37231|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37232|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37233|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37234|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37235|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37236|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37237|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37238|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37239|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37240|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37241|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37242|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37243|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37244|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37245|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37246|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37247|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37248|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37249|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37250|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37251|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37252|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37253|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37254|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37255|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37256|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37257|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37258|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37259|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37260|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37261|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37262|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37263|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37264|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37265|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37266|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37314|NCT02190604|E18|Reported Event|Part 3 QBW251 450mg BID C2|Part 3 QBW251 450mg BID C2
37267|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37268|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37269|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37270|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37271|NCT02190604|O10|Outcome|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37272|NCT02190604|O9|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37273|NCT02190604|O8|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37274|NCT02190604|O7|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37275|NCT02190604|O6|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37276|NCT02190604|O5|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37277|NCT02190604|O4|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37278|NCT02190604|O3|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37279|NCT02190604|O2|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37280|NCT02190604|O1|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37281|NCT02190604|O4|Outcome|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37282|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37283|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37284|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37285|NCT02190604|O4|Outcome|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37286|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37287|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37288|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37289|NCT02190604|O4|Outcome|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37290|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37291|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37292|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37293|NCT02190604|O4|Outcome|Part 3 Placebo|Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37294|NCT02190604|O3|Outcome|Part 3 Cohort 3: QBW251|450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37295|NCT02190604|O2|Outcome|Part 3 Cohort 2: QBW251|450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37296|NCT02190604|O1|Outcome|Part 3 Cohort 1: QBW251|150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
37297|NCT02190604|O16|Outcome|Part 1 Cohort 3: QBW251|Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37298|NCT02190604|O15|Outcome|Part 1 Cohort 2: QBW251|Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37299|NCT02190604|O14|Outcome|Part 1 Cohort 1: QBW251|Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15
37300|NCT02190604|O13|Outcome|Part 2 Placebo|Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37301|NCT02190604|O12|Outcome|Part 2 Cohort 5: QBW251|Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37302|NCT02190604|O11|Outcome|Part 2 Cohort 4: QBW251|Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37303|NCT02190604|O10|Outcome|Part 2 Cohort 3: QBW251|Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37304|NCT02190604|O9|Outcome|Part 2 Cohort 2: QBW251|Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37305|NCT02190604|O8|Outcome|Part 2 Cohort 1: QBW251|Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
37306|NCT02190604|O7|Outcome|Part 1 Placebo|Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37307|NCT02190604|O6|Outcome|Part 1 Cohort 8: QBW251|Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37308|NCT02190604|O5|Outcome|Part 1 Cohort 7: QBW251|Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37309|NCT02190604|O4|Outcome|Part 1 Cohort 6: QBW251(Fed)|Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37310|NCT02190604|O3|Outcome|Part 1 Cohort 6: QBW251|Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37311|NCT02190604|O2|Outcome|Part 1 Cohort 5: QBW251|Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37312|NCT02190604|O1|Outcome|Part 1 Cohort 4: QBW251|Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
37327|NCT02190604|E5|Reported Event|Part 1 QBW251 300mg|Part 1 QBW251 300mg
37328|NCT02190604|E4|Reported Event|Part 1 QBW251 150mg|Part 1 QBW251 150mg
37329|NCT02190604|E3|Reported Event|Part 1 QBW251 25mg|Part 1 QBW251 25mg
37330|NCT02190604|E2|Reported Event|Part 1 QBW251 10mg|Part 1 QBW251 10mg
37331|NCT02190604|E1|Reported Event|Part 1 Placebo|Part 1 Placebo
37332|NCT02190591|B3|Baseline|Total|Total of all reporting groups
37333|NCT02190591|B2|Baseline|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball"
37334|NCT02190591|B1|Baseline|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
37335|NCT02190591|P2|Participant Flow|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball"
37336|NCT02190591|P1|Participant Flow|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
37337|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball"
37338|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
37339|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball"
37340|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
37341|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball"
37342|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
37343|NCT02190591|E2|Reported Event|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball"
37344|NCT02190591|E1|Reported Event|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
37345|NCT02190435|B3|Baseline|Total|Total of all reporting groups
37346|NCT02190435|B2|Baseline|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
37347|NCT02190435|B1|Baseline|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system
Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
37348|NCT02190435|P2|Participant Flow|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
37349|NCT02190435|P1|Participant Flow|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system
Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
37350|NCT02190435|O2|Outcome|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
37351|NCT02190435|O1|Outcome|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system
Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
37352|NCT02190435|O2|Outcome|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
37353|NCT02190435|O1|Outcome|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system
Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
37354|NCT02190435|E2|Reported Event|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
37355|NCT02190435|E1|Reported Event|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system
Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
37356|NCT02189954|B3|Baseline|Total|Total of all reporting groups
37357|NCT02189954|B2|Baseline|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg
Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
37358|NCT02189954|B1|Baseline|Group Routine Care|"The placement according to the manufacturer's instructions.
The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
37359|NCT02189954|P2|Participant Flow|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg
Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group Pressure Limiting (PL)), n=45) cuff inner pressure was held below 60 centimeter of water (cmH2O) (44 mmHg)"
37360|NCT02189954|P1|Participant Flow|Group Routine Care|"The placement according to the manufacturer's instructions.
The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique® (LMU) was lubricated with a water-based gel and the cuff was completely deflated. After induction when bispectral index (BIS) values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
37361|NCT02189954|O2|Outcome|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg
Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
37362|NCT02189954|O1|Outcome|Group Routine Care|"The placement according to the manufacturer's instructions.
The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
37426|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37702|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37363|NCT02189954|O2|Outcome|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg
Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
37364|NCT02189954|O1|Outcome|Group Routine Care|"The placement according to the manufacturer's instructions.
The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
37365|NCT02189954|E2|Reported Event|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg
Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
37366|NCT02189954|E1|Reported Event|Group Routine Care|"The placement according to the manufacturer's instructions.
The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
37367|NCT02189941|B1|Baseline|Healthy Volunteers|Subjects received one dose of deferiprone sustained-release tablets under fed conditions, one dose of deferiprone sustained-release tablets under fasting conditions, and one dose of deferiprone immediate-release tablets under fasting conditions, 7 days apart
37368|NCT02189941|P3|Participant Flow|Ferriprox Fasting, Then DFP-SR Fed, Then DFP-SR Fasting|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:
One dose of Ferriprox immediate-release tablets under fasting conditions
One dose of deferiprone sustained-release tablets under fed conditions
One dose of deferiprone sustained-release tablets under fasting conditions"
37369|NCT02189941|P2|Participant Flow|DFP-SR Fasting, Then Ferriprox Fasting, Then DFP-SR Fed|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:
One dose of deferiprone sustained-release tablets under fasting conditions
One dose of Ferriprox immediate-release tablets under fasting conditions
One dose of deferiprone sustained-release tablets under fed conditions"
37370|NCT02189941|P1|Participant Flow|DFP-SR Fed, Then DFP-SR Fasting, Then Ferriprox Fasting|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:
One dose of deferiprone sustained-release (DFP-SR) tablets under fed conditions
One dose of deferiprone sustained-release tablets under fasting conditions
One dose of Ferriprox immediate-release (IR) tablets under fasting conditions"
37371|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.
Deferiprone immediate-release: Deferiprone immediate-release tablets"
37372|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37373|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37374|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.
Deferiprone immediate-release: Deferiprone immediate-release tablets"
37375|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37376|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37377|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.
Deferiprone immediate-release: Deferiprone immediate-release tablets"
37378|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37379|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37380|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.
Deferiprone immediate-release: Deferiprone immediate-release tablets"
37381|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37382|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37383|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.
Deferiprone immediate-release: Deferiprone immediate-release tablets"
37384|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37385|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37386|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.
Deferiprone immediate-release: Deferiprone immediate-release tablets"
37387|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37567|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks
Polysaccharide Iron Complex 150 mg: Oral Iron"
37388|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37389|NCT02189941|E3|Reported Event|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.
Deferiprone immediate-release: Deferiprone immediate-release tablets"
37390|NCT02189941|E2|Reported Event|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37391|NCT02189941|E1|Reported Event|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.
Deferiprone sustained-release: Deferiprone sustained-release tablets"
37392|NCT02189915|B1|Baseline|Creatine Monohydrate|Creatine monohydrate
37393|NCT02189915|P1|Participant Flow|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
37394|NCT02189915|O1|Outcome|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
37395|NCT02189915|O1|Outcome|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
37396|NCT02189915|E1|Reported Event|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
37397|NCT02189863|B1|Baseline|Overall|Lotrafilcon B MV and lotrafilcon B MF contact lenses worn in Period 1 and Period 2, as randomized
37398|NCT02189863|P2|Participant Flow|AOAMF, Then AOAMV|Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
37399|NCT02189863|P1|Participant Flow|AOAMV, Then AOAMF|Lotrafilcon B MV contact lenses (AOAMV) worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses (AOAMF) worn for 2 weeks in Period 2
37400|NCT02189863|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
37401|NCT02189863|O1|Outcome|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
37402|NCT02189863|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
37403|NCT02189863|O1|Outcome|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
37404|NCT02189863|E5|Reported Event|Habitual|Contact lenses worn in both eyes per subject's habitual prescription on Day 1, Period 1, for a same-day assessment
37405|NCT02189863|E4|Reported Event|Biofinity MF|Comfilcon A multifocal contact lenses worn in both eyes during Period 2 for a same-day assessment
37406|NCT02189863|E3|Reported Event|Lotra B SVD|Lotrafilcon B spherical contact lenses worn with both eyes corrected for distance during Period 1 for a same-day assessment
37407|NCT02189863|E2|Reported Event|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
37408|NCT02189863|E1|Reported Event|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
37409|NCT02189837|B5|Baseline|Total|Total of all reporting groups
37410|NCT02189837|B4|Baseline|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37411|NCT02189837|B3|Baseline|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37412|NCT02189837|B2|Baseline|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37413|NCT02189837|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37414|NCT02189837|P4|Participant Flow|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37415|NCT02189837|P3|Participant Flow|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37416|NCT02189837|P2|Participant Flow|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37417|NCT02189837|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37418|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37419|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37420|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37421|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37422|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37423|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37424|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37425|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37772|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
37427|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37428|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37429|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37430|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37431|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37432|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37433|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37434|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37435|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37436|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37437|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37438|NCT02189837|E4|Reported Event|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37439|NCT02189837|E3|Reported Event|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37440|NCT02189837|E2|Reported Event|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
37441|NCT02189837|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
37442|NCT02189759|B5|Baseline|Total|Total of all reporting groups
37443|NCT02189759|B4|Baseline|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
37444|NCT02189759|B3|Baseline|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
37445|NCT02189759|B2|Baseline|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
37446|NCT02189759|B1|Baseline|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
37447|NCT02189759|P4|Participant Flow|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
37448|NCT02189759|P3|Participant Flow|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
37568|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks
Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
37569|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks
Polysaccharide Iron Complex 150 mg: Oral Iron"
37449|NCT02189759|P2|Participant Flow|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
37450|NCT02189759|P1|Participant Flow|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
37451|NCT02189759|O4|Outcome|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
37452|NCT02189759|O3|Outcome|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
37453|NCT02189759|O2|Outcome|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
37454|NCT02189759|O1|Outcome|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
37455|NCT02189759|O4|Outcome|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
37456|NCT02189759|O3|Outcome|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
37457|NCT02189759|O2|Outcome|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
37458|NCT02189759|O1|Outcome|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
37459|NCT02189759|O2|Outcome|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
37460|NCT02189759|O1|Outcome|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
37461|NCT02189759|O2|Outcome|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
37462|NCT02189759|O1|Outcome|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
37463|NCT02189759|E4|Reported Event|Standard Kangaroo Mother Care to Discharge|Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include remova
37464|NCT02189759|E3|Reported Event|Continuous Kangaroo Mother Care to Discharge|Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the
37465|NCT02189759|E2|Reported Event|Standard Kangaroo Mother Care to One Hour After Birth|Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec
37466|NCT02189759|E1|Reported Event|Continuous Kangaroo Mother Care to One Hour After Birth|Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in
37467|NCT02189317|B3|Baseline|Total|Total of all reporting groups
37468|NCT02189317|B2|Baseline|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37469|NCT02189317|B1|Baseline|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37470|NCT02189317|P2|Participant Flow|Exparel (Bupivacaine Liposome)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37471|NCT02189317|P1|Participant Flow|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37472|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37473|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37474|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37475|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37570|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks
Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
37476|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37477|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37478|NCT02189317|E2|Reported Event|Exparel (Bupivacaine Liposome)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37479|NCT02189317|E1|Reported Event|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
37480|NCT02189252|B5|Baseline|Total|Total of all reporting groups
37481|NCT02189252|B4|Baseline|Treatment Sequence 4|Lovaza 4 g per day:Epanova 2 g per day: 4 subjects
37482|NCT02189252|B3|Baseline|Treatment Sequence 3|Epanova 2 g per day:Lovaza 4 g per day
37483|NCT02189252|B2|Baseline|Treatment Sequence 2|Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
37484|NCT02189252|B1|Baseline|Treatment Sequence 1|Epanova 4 g per day:Lovaza 4 g per day
37485|NCT02189252|P4|Participant Flow|Treatment Sequence 4|Lovaza 4g per day:Epanova 2g per day:
37486|NCT02189252|P3|Participant Flow|Treatment Sequence 3|Epanova 2g per day:Lovaza 4g per day:
37487|NCT02189252|P2|Participant Flow|Treatment Sequence 2|Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
37488|NCT02189252|P1|Participant Flow|Treatment Sequence 1|Epanova 4g per day: Lovaza 4g per day
37489|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
37490|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
37491|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
37492|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
37493|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
37494|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
37495|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
37496|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
37497|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
37498|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
37499|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
37500|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
37501|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
37502|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
37503|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
37504|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
37505|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
37506|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
37507|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
37508|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
37509|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
37510|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
37511|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
37512|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
37513|NCT02189252|E6|Reported Event|Lovaza 4 g (II)|Treatment period II
37514|NCT02189252|E5|Reported Event|Epanova 4 g (II)|Treatment period II
37515|NCT02189252|E4|Reported Event|Epanova 2 g (II)|Treatment period II
37516|NCT02189252|E3|Reported Event|Lovaza 4 g (I)|Treatment period I
37517|NCT02189252|E2|Reported Event|Epanova 4 g (I)|Treatment period I
37518|NCT02189252|E1|Reported Event|Epanova 2 g (I)|Treatment period I
37519|NCT02189161|B1|Baseline|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
37520|NCT02189161|P1|Participant Flow|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
37521|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
37522|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
37571|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks
Polysaccharide Iron Complex 150 mg: Oral Iron"
37523|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
37524|NCT02189161|E1|Reported Event|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
37525|NCT02189122|B3|Baseline|Total|Total of all reporting groups
37526|NCT02189122|B2|Baseline|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days."
37527|NCT02189122|B1|Baseline|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days."
37528|NCT02189122|P2|Participant Flow|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days.
Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence NHP544C 81 mg, NHP544C 162 mg, placebo; two subjects participated in the sequence NHP544C 162 mg, placebo, NHP544C 81 mg."
37529|NCT02189122|P1|Participant Flow|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days.
Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence Aspirin 81 mg, Aspirin 162.5 mg, placebo; two subjects participated in the sequence placebo, Aspirin 162.5 mg, Aspirin 81 mg."
37530|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days."
37531|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days."
37532|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days."
37533|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days."
37534|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days."
37535|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days."
37701|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
37536|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days."
37537|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days."
37538|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days."
37539|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days."
37540|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days."
37541|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days."
37542|NCT02189122|E2|Reported Event|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.
NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.
Placebo: Subjects will take matching placebo for five days."
37543|NCT02189122|E1|Reported Event|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.
Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.
Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.
Placebo: Subjects will take matching placebo for five days."
37544|NCT02188849|B3|Baseline|Total|Total of all reporting groups
37545|NCT02188849|B2|Baseline|Placebo|"Maltodextrin 5 g/day to be dissolved in water
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
37546|NCT02188849|B1|Baseline|Creatine|"Creatine 5 g/ day
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.
Creatine: Creatine powder 5 g day"
37547|NCT02188849|P2|Participant Flow|Placebo|"Maltodextrin 5 g/day to be dissolved in water
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
37548|NCT02188849|P1|Participant Flow|Creatine|"Creatine 5 g/ day
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.
Creatine: Creatine powder 5 g day"
37572|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks
Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
37573|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks
Polysaccharide Iron Complex 150 mg: Oral Iron"
60122|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
37549|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
37550|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.
Creatine: Creatine powder 5 g day"
37551|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
37552|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.
Creatine: Creatine powder 5 g day"
37553|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
37554|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.
Creatine: Creatine powder 5 g day"
37555|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
37556|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.
Creatine: Creatine powder 5 g day"
37557|NCT02188849|E2|Reported Event|Placebo|"Maltodextrin 5 g/day to be dissolved in water
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
37558|NCT02188849|E1|Reported Event|Creatine|"Creatine 5 g/ day
Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.
Creatine: Creatine powder 5 g day"
37559|NCT02188784|B3|Baseline|Total|Total of all reporting groups
37560|NCT02188784|B2|Baseline|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks
Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
37561|NCT02188784|B1|Baseline|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks
Polysaccharide Iron Complex 150 mg: Oral Iron"
37562|NCT02188784|P2|Participant Flow|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks
Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
37563|NCT02188784|P1|Participant Flow|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks
Polysaccharide Iron Complex 150 mg: Oral Iron"
37564|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks
Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
37565|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks
Polysaccharide Iron Complex 150 mg: Oral Iron"
37566|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks
Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
37769|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
37574|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks
Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
37575|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks
Polysaccharide Iron Complex 150 mg: Oral Iron"
37576|NCT02188784|E2|Reported Event|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks
Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
37577|NCT02188784|E1|Reported Event|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks
Polysaccharide Iron Complex 150 mg: Oral Iron"
37578|NCT02188589|B1|Baseline|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
37579|NCT02188589|P1|Participant Flow|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
37580|NCT02188589|O1|Outcome|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
37581|NCT02188589|O1|Outcome|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
37582|NCT02188589|E1|Reported Event|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
37583|NCT02187809|B1|Baseline|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
Clobazam"
37584|NCT02187809|P1|Participant Flow|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
Clobazam"
37585|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
Clobazam"
37586|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
Clobazam"
37587|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
Clobazam"
37588|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
Clobazam"
37589|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
Clobazam"
37590|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
Clobazam"
37591|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
Clobazam"
37592|NCT02187809|E1|Reported Event|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
Clobazam"
37593|NCT02187744|B3|Baseline|Total|Total of all reporting groups
37594|NCT02187744|B2|Baseline|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37595|NCT02187744|B1|Baseline|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37596|NCT02187744|P2|Participant Flow|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37597|NCT02187744|P1|Participant Flow|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin area under the concentration versus time curve (AUC) 6 were administered on Day 1 of each cycle.
37598|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37599|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37600|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37601|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37602|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37603|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37604|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37605|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37770|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
37606|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37607|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37608|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37609|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37610|NCT02187744|E2|Reported Event|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37611|NCT02187744|E1|Reported Event|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
37612|NCT02187029|B5|Baseline|Total|Total of all reporting groups
37613|NCT02187029|B4|Baseline|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37614|NCT02187029|B3|Baseline|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37615|NCT02187029|B2|Baseline|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37616|NCT02187029|B1|Baseline|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37617|NCT02187029|P4|Participant Flow|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37618|NCT02187029|P3|Participant Flow|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37619|NCT02187029|P2|Participant Flow|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37620|NCT02187029|P1|Participant Flow|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37621|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37622|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37623|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37624|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37625|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37626|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37627|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37628|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37629|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37630|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37631|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37632|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37633|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37634|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37635|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
39235|NCT02171195|E9|Reported Event|Group 8 1200 mg|BIA 2-093 1200mg or placebo
37636|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37637|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37638|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37639|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37640|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37641|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37642|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37643|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37644|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37645|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37646|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37647|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37648|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37649|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37650|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37651|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37652|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37653|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37654|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37655|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37656|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37657|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37658|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37659|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37660|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37661|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37662|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37663|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37664|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37665|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37666|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
39236|NCT02171195|E8|Reported Event|Group 7 900 mg|BIA 2-093 900mg or placebo
37667|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37668|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37669|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37670|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37671|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37672|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37673|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37674|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37675|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37676|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37677|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37678|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37679|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37680|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37681|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37682|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37683|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37684|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37685|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37686|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37687|NCT02187029|E4|Reported Event|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37688|NCT02187029|E3|Reported Event|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
37689|NCT02187029|E2|Reported Event|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
37690|NCT02187029|E1|Reported Event|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37691|NCT02187016|B5|Baseline|Total|Total of all reporting groups
37692|NCT02187016|B4|Baseline|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
37693|NCT02187016|B3|Baseline|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
37694|NCT02187016|B2|Baseline|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37695|NCT02187016|B1|Baseline|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37696|NCT02187016|P4|Participant Flow|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
37697|NCT02187016|P3|Participant Flow|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
37698|NCT02187016|P2|Participant Flow|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37699|NCT02187016|P1|Participant Flow|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37700|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
37703|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37704|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
37705|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
37706|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37707|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37708|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
37709|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
37710|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37711|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37712|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
37713|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
37714|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37715|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37716|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
37717|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
37718|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37719|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37720|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
37721|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
37722|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37723|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37724|NCT02187016|E4|Reported Event|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
37725|NCT02187016|E3|Reported Event|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
37726|NCT02187016|E2|Reported Event|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37727|NCT02187016|E1|Reported Event|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37728|NCT02186808|B1|Baseline|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
37729|NCT02186808|P1|Participant Flow|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
37730|NCT02186808|O1|Outcome|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
37731|NCT02186808|O1|Outcome|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
37732|NCT02186808|E1|Reported Event|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
37733|NCT02186665|B3|Baseline|Total|Total of all reporting groups
37734|NCT02186665|B2|Baseline|Placebo|Placebo comparator
37735|NCT02186665|B1|Baseline|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
37736|NCT02186665|P2|Participant Flow|Placebo|Placebo comparator
37737|NCT02186665|P1|Participant Flow|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
37738|NCT02186665|O2|Outcome|Placebo|Placebo Comparator
37739|NCT02186665|O1|Outcome|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
37740|NCT02186665|E2|Reported Event|Placebo|Placebo Comparator
37741|NCT02186665|E1|Reported Event|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
37742|NCT02186587|B3|Baseline|Total|Total of all reporting groups
37771|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
37743|NCT02186587|B2|Baseline|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant as part of standard of care.
Off-the-shelf total knee implant"
37744|NCT02186587|B1|Baseline|ConforMIS|"Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.
ConforMIS custom total knee"
37745|NCT02186587|P2|Participant Flow|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant.
Off-the-shelf total knee implant"
37746|NCT02186587|P1|Participant Flow|ConforMIS|"Subjects in this arm will receive a ConforMIS custom total knee implant.
ConforMIS custom total knee"
37747|NCT02186587|O1|Outcome|ConforMIS|"Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.
ConforMIS custom total knee"
37748|NCT02186587|E2|Reported Event|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant.
Off-the-shelf total knee implant"
37749|NCT02186587|E1|Reported Event|ConforMIS|"Subjects in this arm will receive a ConforMIS custom total knee implant.
ConforMIS custom total knee"
37750|NCT02186223|B1|Baseline|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
37751|NCT02186223|P1|Participant Flow|The Angel® Catheter|"All eligible subjects will receive an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
37752|NCT02186223|O1|Outcome|Angel® Catheter Pre-Removal Cavogram|Number analyzed includes all subjects that had an Angel® Catheter placed, and a cavogram was performed prior to removal.
37753|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
37754|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
37755|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
37756|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
37757|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
37758|NCT02186223|E1|Reported Event|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
37759|NCT02185729|B1|Baseline|Healthy Volunteer|"Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)
Intralipid
ClinOleic
Dextrose
Saline (control)"
37760|NCT02185729|P1|Participant Flow|Healthy Volunteer|"Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)
Intralipid
ClinOleic
Dextrose
Saline (control)"
37761|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
37762|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
37763|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
37764|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
37765|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
37766|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
37767|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
37768|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
37773|NCT02185729|E1|Reported Event|Healthy Volunteer|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)
37775|NCT02185534|B6|Baseline|First US, Then Japanese, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
37776|NCT02185534|B5|Baseline|First US, Then European, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
37777|NCT02185534|B4|Baseline|First Japanese, Then US, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
37778|NCT02185534|B3|Baseline|First Japanese, Then European, Then US Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3
37779|NCT02185534|B2|Baseline|First European, Then US, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
37780|NCT02185534|B1|Baseline|First European, Then Japanese, Then US Clopidogrel|"A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA
- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3"
37781|NCT02185534|P6|Participant Flow|First US, Then Japanese, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
37782|NCT02185534|P5|Participant Flow|First US, Then European, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
37783|NCT02185534|P4|Participant Flow|First Japanese, Then US, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
37784|NCT02185534|P3|Participant Flow|First Japanese, Then European, Then US Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3
37785|NCT02185534|P2|Participant Flow|First European, Then US, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
37786|NCT02185534|P1|Participant Flow|First European, Then Japanese, Then US Clopidogrel|"A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA
- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3"
37787|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
37788|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
37789|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
37790|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
37791|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
37792|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
37793|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
37794|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
37795|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
37796|NCT02185534|E4|Reported Event|Total Number of Participants|total number of subjects exposed to any treatment
37797|NCT02185534|E3|Reported Event|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
37798|NCT02185534|E2|Reported Event|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
37799|NCT02185534|E1|Reported Event|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
37800|NCT02185339|B3|Baseline|Total|Total of all reporting groups
37801|NCT02185339|B2|Baseline|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37802|NCT02185339|B1|Baseline|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37803|NCT02185339|P2|Participant Flow|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37804|NCT02185339|P1|Participant Flow|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37805|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37806|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37807|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37808|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37809|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37810|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
38117|NCT02180893|B1|Baseline|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery
Paravertebral Block: Paravertebral nerve block injection"
38044|NCT02181530|E1|Reported Event|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
37811|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37812|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37813|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37814|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37815|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37816|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37817|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37818|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37819|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37820|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37882|NCT02185105|E1|Reported Event|Comfilcon A MTO|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
37883|NCT02184624|B6|Baseline|Total|Total of all reporting groups
39237|NCT02171195|E7|Reported Event|Group 6 600 mg|BIA 2-093 600mg or placebo
37821|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37822|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37823|NCT02185339|E2|Reported Event|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37824|NCT02185339|E1|Reported Event|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
37825|NCT02185183|B1|Baseline|AlequelTM|"AlequelTM
Alequel: Alequel"
37826|NCT02185183|P1|Participant Flow|AlequelTM 30 ng Once a Day Orally|"AlequelTM 30 ng once a day orally
Alequel: Alequel"
37827|NCT02185183|O1|Outcome|AlequelTM|"AlequelTM
Alequel: Alequel"
37828|NCT02185183|E1|Reported Event|AlequelTM|"AlequelTM
Alequel: Alequel"
37829|NCT02185131|B3|Baseline|Total|Total of all reporting groups
37830|NCT02185131|B2|Baseline|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
37831|NCT02185131|B1|Baseline|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
37832|NCT02185131|P2|Participant Flow|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
37833|NCT02185131|P1|Participant Flow|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
37834|NCT02185131|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
37835|NCT02185131|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
37836|NCT02185131|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
38081|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
37837|NCT02185131|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
37838|NCT02185131|E2|Reported Event|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
37839|NCT02185131|E1|Reported Event|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
37840|NCT02185105|B1|Baseline|Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
37841|NCT02185105|P1|Participant Flow|Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
37842|NCT02185105|O2|Outcome|Comfilcon A Toric|
37843|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
37844|NCT02185105|O2|Outcome|Comfilcon A Toric|
37845|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
37846|NCT02185105|O2|Outcome|Comfilcon A Toric|
37847|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
37848|NCT02185105|O2|Outcome|Comfilcon A Toric|
37849|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
37850|NCT02185105|O2|Outcome|Comfilcon A Toric|
37851|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
37852|NCT02185105|O2|Outcome|Comfilcon A Toric|
37853|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
37854|NCT02185105|O2|Outcome|Comfilcon A Toric|
37855|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
37856|NCT02185105|O2|Outcome|Comfilcon A Toric|
37857|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
37858|NCT02185105|O2|Outcome|Comfilcon A Toric|
37859|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
37860|NCT02185105|O2|Outcome|Comfilcon A Toric|
37861|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
37862|NCT02185105|O2|Outcome|Comfilcon A Toric|
37863|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
37864|NCT02185105|O2|Outcome|Comfilcon A Toric|
37865|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
37866|NCT02185105|O2|Outcome|Comfilcon A Toric|
37867|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
37868|NCT02185105|O2|Outcome|Comfilcon A Toric|
37869|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
37870|NCT02185105|O3|Outcome|No Preference|
37871|NCT02185105|O2|Outcome|Comfilcon A Toric|
37872|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
37873|NCT02185105|O2|Outcome|Comfilcon A Toric|
37874|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
37875|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
37876|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
37877|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
37878|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
37879|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
37880|NCT02185105|O1|Outcome|Comfilcon A XR (Extended Range) Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
37881|NCT02185105|E2|Reported Event|Comfilcon A|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
comfilcon A MTO: Randomized to a test lens in one eye and control lens in the other as a matched pair."
37932|NCT02184624|E2|Reported Event|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37884|NCT02184624|B5|Baseline|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37885|NCT02184624|B4|Baseline|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37886|NCT02184624|B3|Baseline|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37887|NCT02184624|B2|Baseline|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37888|NCT02184624|B1|Baseline|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37889|NCT02184624|P5|Participant Flow|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37890|NCT02184624|P4|Participant Flow|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37891|NCT02184624|P3|Participant Flow|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37892|NCT02184624|P2|Participant Flow|Sub-study 2: ELLIPTA Vs Metered-dose Inhaler (MDI)|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37893|NCT02184624|P1|Participant Flow|Sub-study 1:ELLIPTA Versus (Vs) DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily Chronic Obstructive Pulmonary Disease (COPD) maintenance and other medication(s) during the study.
37894|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37895|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37896|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37897|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37898|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37899|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37900|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37901|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37902|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37903|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37904|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37905|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37906|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37907|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
39238|NCT02171195|E6|Reported Event|Group 5 400 mg|BIA 2-093 or 400mg or placebo
37908|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37909|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37910|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37911|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37912|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37913|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37914|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37915|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37916|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37917|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37918|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37919|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37920|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37921|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37922|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37923|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37924|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37925|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37926|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37927|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37928|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37929|NCT02184624|E5|Reported Event|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37930|NCT02184624|E4|Reported Event|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37931|NCT02184624|E3|Reported Event|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
38116|NCT02180893|B2|Baseline|No Block|"Patients who did not receive PVB
Placebo Comparator: No block
Patients who did not receive PVB"
37933|NCT02184624|E1|Reported Event|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
37934|NCT02184494|B4|Baseline|Total|Total of all reporting groups
37935|NCT02184494|B3|Baseline|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37936|NCT02184494|B2|Baseline|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37937|NCT02184494|B1|Baseline|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37938|NCT02184494|P3|Participant Flow|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37939|NCT02184494|P2|Participant Flow|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37940|NCT02184494|P1|Participant Flow|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37941|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37942|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37943|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37944|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37945|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37993|NCT02183675|P2|Participant Flow|T80-H12.5 / T80-A5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
39239|NCT02171195|E5|Reported Event|Group 4 200 mg|BIA 2-093 200mg or placebo
37946|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37947|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37948|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37949|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37950|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37951|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37952|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37953|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37954|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37955|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37956|NCT02184494|E3|Reported Event|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37957|NCT02184494|E2|Reported Event|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
38043|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
60123|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
37958|NCT02184494|E1|Reported Event|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration"
37959|NCT02182895|B3|Baseline|Total|Total of all reporting groups
37960|NCT02182895|B2|Baseline|Standard Therapy Group|Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime.
37961|NCT02182895|B1|Baseline|Saxagliptin Group|"DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime.
Saxagliptin: 2.5-5 mg daily"
37962|NCT02182895|P2|Participant Flow|Standard Therapy Group|No saxagliptin treatment
37963|NCT02182895|P1|Participant Flow|Saxagliptin Group|saxagliptin 2.5-5 mg daily
37964|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
37965|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
37966|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
37967|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
37968|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
37969|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
37970|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
37971|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
37972|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
37973|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
37974|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
37975|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
37976|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
37977|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
37978|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
37979|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
37980|NCT02182895|E2|Reported Event|Standard Therapy Group|No saxagliptin treatment
37981|NCT02182895|E1|Reported Event|Saxagliptin Group|saxagliptin 2.5-5 mg daily
37982|NCT02183675|B7|Baseline|Total|Total of all reporting groups
37983|NCT02183675|B6|Baseline|T80-H12.5 / T80-A5-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
37984|NCT02183675|B5|Baseline|T80-A5-H12.5 / T80-A5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
37985|NCT02183675|B4|Baseline|T80-A5 / T80-H12.5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
37986|NCT02183675|B3|Baseline|T80-A5 / T80-A5-H12.5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
37987|NCT02183675|B2|Baseline|T80-H12.5 / T80-A5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
37988|NCT02183675|B1|Baseline|T80-A5-H12.5 / T80-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
37989|NCT02183675|P6|Participant Flow|T80-H12.5 / T80-A5-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
37990|NCT02183675|P5|Participant Flow|T80-A5-H12.5 / T80-A5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
37991|NCT02183675|P4|Participant Flow|T80-A5 / T80-H12.5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
37992|NCT02183675|P3|Participant Flow|T80-A5 / T80-A5-H12.5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
38342|NCT02178540|O1|Outcome|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
37994|NCT02183675|P1|Participant Flow|T80-A5-H12.5 / T80-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:
Telmisartan 80mg/Amlodipine 5mg/ hydrochlorothiazide (HCTZ) 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
Telmisartan 80mg/ HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
37995|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
37996|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
37997|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
37998|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
37999|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
38000|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
38001|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
38002|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
38003|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
38004|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
38005|NCT02183675|O3|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
38006|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
38007|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
38008|NCT02183675|O3|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
38009|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
38010|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
38011|NCT02183675|E4|Reported Event|All Patients|"All participants in the study. Participants received three treatments in a randomised order
T80-A5-H12.5
T80-A5
T80-H12.5"
38012|NCT02183675|E3|Reported Event|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
38013|NCT02183675|E2|Reported Event|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
38014|NCT02183675|E1|Reported Event|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
38015|NCT02183519|B3|Baseline|Total|Total of all reporting groups
38016|NCT02183519|B2|Baseline|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
38017|NCT02183519|B1|Baseline|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
38018|NCT02183519|P2|Participant Flow|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
38019|NCT02183519|P1|Participant Flow|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
38020|NCT02183519|O2|Outcome|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
38021|NCT02183519|O1|Outcome|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
38022|NCT02183519|E2|Reported Event|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
38023|NCT02183519|E1|Reported Event|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
38024|NCT02181790|B3|Baseline|Total|Total of all reporting groups
38025|NCT02181790|B2|Baseline|Second Group|"excimer laser treatment to both palms and/or soles
Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
38026|NCT02181790|B1|Baseline|First Group|"excimer laser treatment to one palm and/or one sole
Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
38027|NCT02181790|P2|Participant Flow|Excimer Laser (Both Palms/Soles)|"excimer laser treatment to both palms and/or soles
Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
38028|NCT02181790|P1|Participant Flow|Excimer Laser (One Palm/Sole)|"excimer laser treatment to one palm and/or one sole
Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
38029|NCT02181790|O2|Outcome|Excimer Laser (Both Palms/Soles)|"excimer laser treatment to both palms and/or soles
Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
38030|NCT02181790|O1|Outcome|Excimer Laser (One Palm/Sole)|"excimer laser treatment to one palm and/or one sole
Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
38031|NCT02181790|O2|Outcome|Second Group|"excimer laser treatment to both palms and/or soles
Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
38032|NCT02181790|O1|Outcome|First Group|"excimer laser treatment to one palm and/or one sole
Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
38033|NCT02181790|E2|Reported Event|Second Group|"excimer laser treatment to both palms and/or soles
Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
38034|NCT02181790|E1|Reported Event|First Group|"excimer laser treatment to one palm and/or one sole
Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
38035|NCT02181530|B1|Baseline|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
38036|NCT02181530|P1|Participant Flow|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
38037|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
38038|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
38039|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
38040|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
38041|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
38042|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
38080|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38046|NCT02181517|B3|Baseline|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38047|NCT02181517|B2|Baseline|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38048|NCT02181517|B1|Baseline|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38049|NCT02181517|P3|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38050|NCT02181517|P2|Participant Flow|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38051|NCT02181517|P1|Participant Flow|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38052|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38053|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38054|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38055|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38056|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38057|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38058|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38059|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38060|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38061|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38062|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38063|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38064|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38065|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38066|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38067|NCT02181517|E3|Reported Event|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38068|NCT02181517|E2|Reported Event|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38069|NCT02181517|E1|Reported Event|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38070|NCT02181504|B4|Baseline|Total|Total of all reporting groups
38071|NCT02181504|B3|Baseline|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38072|NCT02181504|B2|Baseline|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38073|NCT02181504|B1|Baseline|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38074|NCT02181504|P3|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38075|NCT02181504|P2|Participant Flow|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38076|NCT02181504|P1|Participant Flow|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38077|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38078|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38079|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38082|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38083|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38084|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38085|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38086|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38087|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38088|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38089|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38090|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38091|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38092|NCT02181504|E3|Reported Event|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
38093|NCT02181504|E2|Reported Event|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38094|NCT02181504|E1|Reported Event|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
38095|NCT02181387|B3|Baseline|Total|Total of all reporting groups
38096|NCT02181387|B2|Baseline|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses
Placebo"
38097|NCT02181387|B1|Baseline|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses
Acetaminophen: administered every 6 hours by mouth up to 3 doses"
38098|NCT02181387|P2|Participant Flow|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses
Placebo"
38099|NCT02181387|P1|Participant Flow|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses
Acetaminophen: administered every 6 hours by mouth up to 3 doses"
38100|NCT02181387|O2|Outcome|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses
Placebo"
38101|NCT02181387|O1|Outcome|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses
Acetaminophen: administered every 6 hours by mouth up to 3 doses"
38102|NCT02181387|E2|Reported Event|Placebo|"placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses
Placebo"
38103|NCT02181387|E1|Reported Event|Acetaminophen|"1000 mg every 6 hours during labor up to maximum 3 doses
Acetaminophen: administered every 6 hours by mouth up to 3 doses"
38104|NCT02181140|B1|Baseline|EUS Guided FNA and Fine Needle Punction|"punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order
EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics"
38105|NCT02181140|P1|Participant Flow|EUS Guided FNA and Fine Needle Punction|"punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order
EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics"
38106|NCT02181140|O1|Outcome|EUS Guided FNA|EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
38107|NCT02181140|O1|Outcome|EUS Guided Pro Core FNA|EUS guided Pro core FNA: Histology samples (not cytology)
38108|NCT02181140|O1|Outcome|EUS Guided Pro Core FNA|EUS guided punction of a lesion by pro core fine needle to evacuate histology and smear biologics
38109|NCT02181140|E1|Reported Event|EUS Guided FNA|EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
38110|NCT02181127|B1|Baseline|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).
Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
38111|NCT02181127|P1|Participant Flow|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).
Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
38112|NCT02181127|O2|Outcome|Placebo|Glucagon-only Bionic Pancreas delivered placebo during 7 of the 14 days. The order of the placebo days was randomized in blocks of 2, with no more than 2 days in a row of placebo.
38113|NCT02181127|O1|Outcome|Glucagon-only Bionic Pancreas|Glucagon-only Bionic Pancreas delivered glucagon during 7 of the 14 days. The order of the glucagon days was randomized in blocks of 2, with no more than 2 days in a row of glucagon.
38114|NCT02181127|E1|Reported Event|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).
Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
38115|NCT02180893|B3|Baseline|Total|Total of all reporting groups
38343|NCT02178540|E4|Reported Event|Open Label (>=18) Years Old|
38118|NCT02180893|P2|Participant Flow|No Block|"Patients who did not receive PVB
Placebo Comparator: No block
Patients who did not receive PVB"
38119|NCT02180893|P1|Participant Flow|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery
Paravertebral Block: Paravertebral nerve block injection"
40086|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
38120|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB
Placebo Comparator: No block
Patients who did not receive PVB"
38121|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery
Paravertebral Block: Paravertebral nerve block injection"
38122|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB
Placebo Comparator: No block
Patients who did not receive PVB"
38123|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery
Paravertebral Block: Paravertebral nerve block injection"
38124|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB
Placebo Comparator: No block
Patients who did not receive PVB"
38125|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery
Paravertebral Block: Paravertebral nerve block injection"
38126|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB
Placebo Comparator: No block
Patients who did not receive PVB"
38127|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery
Paravertebral Block: Paravertebral nerve block injection"
38128|NCT02180893|E2|Reported Event|No Block|"Patients who did not receive PVB
Placebo Comparator: No block
Patients who did not receive PVB"
38129|NCT02180893|E1|Reported Event|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery
Paravertebral Block: Paravertebral nerve block injection"
38130|NCT02180828|B3|Baseline|Total|Total of all reporting groups
38131|NCT02180828|B2|Baseline|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38132|NCT02180828|B1|Baseline|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38133|NCT02180828|P2|Participant Flow|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38134|NCT02180828|P1|Participant Flow|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38135|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38136|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38137|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38138|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38139|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38140|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38141|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38142|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38143|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38144|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38145|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38146|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38147|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38148|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38149|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38150|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38151|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38152|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38153|NCT02180828|E2|Reported Event|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)
Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
38154|NCT02180828|E1|Reported Event|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
38155|NCT02180646|B3|Baseline|Total|Total of all reporting groups
38344|NCT02178540|E3|Reported Event|Open Label (11-17)Years Old|
38156|NCT02180646|B2|Baseline|High Protein Then High Carb Breakfast|A high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) for 7 days, followed by a 7-day washout, followed by a high carbohydrate breakfast for 7 days
38354|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
38157|NCT02180646|B1|Baseline|High Carb Then High Protein Breakfast|A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) for 7 days, followed by 7-day washout, followed by a high protein breakfast for 7 days
38158|NCT02180646|P2|Participant Flow|High Protein Then High Carb Breakfast|A high protein breakfast for 7 days, followed by a 7-day washout, followed a high carbohydrate breakfast for 7 days
38159|NCT02180646|P1|Participant Flow|High Carb Then High Protein Breakfast|A high carbohydrate breakfast for 7 days, followed by a 7-day washout, followed a high protein breakfast for 7 days
38160|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast"
38161|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast"
38162|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast"
38163|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast"
38164|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast"
38165|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast"
38166|NCT02180646|E2|Reported Event|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast"
38167|NCT02180646|E1|Reported Event|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast"
38168|NCT02180230|B1|Baseline|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty
Shorty implants: Dental implant insertion to maxilla or mandible"
38169|NCT02180230|P1|Participant Flow|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty
Shorty implants: Dental implant insertion to maxilla or mandible"
38170|NCT02180230|O1|Outcome|Shorty Implants|"Brånemark System Mk III Shorty and NobelSpeedy Shorty
Shorty implants: Dental implant insertion to maxilla or mandible"
38171|NCT02180230|O1|Outcome|Shorty Implants|"Brånemark System Mk III Shorty and NobelSpeedy Shorty
Shorty implants: Dental implant insertion to maxilla or mandible"
38172|NCT02180230|E1|Reported Event|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty
Shorty implants: Dental implant insertion to maxilla or mandible"
38173|NCT02180061|B3|Baseline|Total|Total of all reporting groups
38174|NCT02180061|B2|Baseline|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38175|NCT02180061|B1|Baseline|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38176|NCT02180061|P2|Participant Flow|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38177|NCT02180061|P1|Participant Flow|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, intravenously (IV) over 30 minutes on Day 1 of each 3-week dosing cycle (Q3W).
38178|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38179|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38180|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38181|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38182|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38183|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38184|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38185|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38186|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38187|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38188|NCT02180061|E2|Reported Event|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38189|NCT02180061|E1|Reported Event|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
38190|NCT02179892|B3|Baseline|Total|Total of all reporting groups
38191|NCT02179892|B2|Baseline|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
38192|NCT02179892|B1|Baseline|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
38193|NCT02179892|P2|Participant Flow|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection were administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
38345|NCT02178540|E2|Reported Event|Total - All Participants|
38223|NCT02179424|E4|Reported Event|Group D|"Phone counseling (Motivational intervention) + booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38194|NCT02179892|P1|Participant Flow|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) were administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block."
38195|NCT02179892|O2|Outcome|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
38196|NCT02179892|O1|Outcome|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
38197|NCT02179892|O2|Outcome|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
38198|NCT02179892|O1|Outcome|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
38199|NCT02179892|O2|Outcome|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
38200|NCT02179892|O1|Outcome|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
38201|NCT02179892|O2|Outcome|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
38202|NCT02179892|O1|Outcome|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
38203|NCT02179892|E2|Reported Event|Group 2-Bupivacaine and Dexamethasone IV|"Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block."
38204|NCT02179892|E1|Reported Event|Group 1-Exparel|"Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block"
38205|NCT02179424|B5|Baseline|Total|Total of all reporting groups
38206|NCT02179424|B4|Baseline|Group D|"Phone counseling (Motivational intervention) + booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38207|NCT02179424|B3|Baseline|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38208|NCT02179424|B2|Baseline|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38209|NCT02179424|B1|Baseline|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38210|NCT02179424|P4|Participant Flow|Phone Counseling + Booklet + SMS|"Phone counseling (Motivational intervention) + booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38211|NCT02179424|P3|Participant Flow|Phone Counseling + Health Talk + Booklet + SMS|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38212|NCT02179424|P2|Participant Flow|Face-to-face Counseling + Booklet + SMS|"Face to Face counseling (Motivational intervention) + Booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38213|NCT02179424|P1|Participant Flow|Health Talk + Workshop + Booklet + SMS|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38214|NCT02179424|O4|Outcome|Group D|"Phone counseling (Motivational intervention) + booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38215|NCT02179424|O3|Outcome|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38216|NCT02179424|O2|Outcome|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38217|NCT02179424|O1|Outcome|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38218|NCT02179424|O4|Outcome|Group D|"Phone counseling (Motivational intervention) + booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38219|NCT02179424|O3|Outcome|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38220|NCT02179424|O2|Outcome|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38221|NCT02179424|O1|Outcome|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38222|NCT02179424|O1|Outcome|Employers' KAP|Employers' knowledge on smoking and quitting
38346|NCT02178540|E1|Reported Event|Open Label (6-10) Years Old|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
38224|NCT02179424|E3|Reported Event|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38225|NCT02179424|E2|Reported Event|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38226|NCT02179424|E1|Reported Event|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)
Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
38227|NCT02179398|B3|Baseline|Total|Total of all reporting groups
38228|NCT02179398|B2|Baseline|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.
(PCT and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group"
38229|NCT02179398|B1|Baseline|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(WBC and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group"
38230|NCT02179398|P2|Participant Flow|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.
(PCT and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group"
38231|NCT02179398|P1|Participant Flow|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(WBC and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group"
38232|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
38233|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
38234|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
38235|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
38236|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
38237|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
38238|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
38239|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
38240|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.
(PCT and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group"
38241|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(WBC and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group"
38242|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.
(PCT and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group"
38243|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(WBC and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group"
38244|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.
(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group"
38245|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group"
38246|NCT02179398|E2|Reported Event|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.
(PCT and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group"
38247|NCT02179398|E1|Reported Event|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(WBC and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group"
38248|NCT02178995|B3|Baseline|Total|Total of all reporting groups
38249|NCT02178995|B2|Baseline|Healthy Controls|Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
38250|NCT02178995|B1|Baseline|Participants With Epilepsy|"Participants received three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time. Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed."
38353|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
38251|NCT02178995|P9|Participant Flow|40mg, 20mg, Then Placebo (One Participant)|This study was originally intended to use 40mg, 20mg, and placebo doses rather than 20mg, 10mg, and placebo. This individual developed tachycardia (see adverse events) on the 40mg dose, and was withdrawn from the double-blind portion as a result. We removed the 40mg doses from this study and replaced them with 10mg doses. No other participant received a 40mg dose. This participant rejoined the open-label portion after consultation with his PCP due to significant perceived benefit from the MPH dose.
38252|NCT02178995|P8|Participant Flow|20mg, 10mg, Then Placebo - Double-blind|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38253|NCT02178995|P7|Participant Flow|20mg, Placebo, Then 10mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38254|NCT02178995|P6|Participant Flow|Placebo, 10mg, Then 20mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38255|NCT02178995|P5|Participant Flow|Placebo, 20mg, Then 10mg (Double-blind|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38256|NCT02178995|P4|Participant Flow|10mg, Placebo, Then 20mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38257|NCT02178995|P3|Participant Flow|10mg, 20mg, Then Placebo (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38258|NCT02178995|P2|Participant Flow|Healthy Controls|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38259|NCT02178995|P1|Participant Flow|Participants With Epilepsy (Open-label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After a four week treatment trial, their scores on the batteries and questionnaires were again assessed.
38260|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38261|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38347|NCT02178059|B1|Baseline|Randomized Subjects|All randomized subjects
38348|NCT02178059|P2|Participant Flow|M2 First, Then M3|Sequence 2: M2 first, then M3
38262|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
38263|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
38264|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38265|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38266|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38267|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38268|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38269|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38270|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38271|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38272|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
38273|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
38274|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
38275|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38276|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38349|NCT02178059|P1|Participant Flow|M3 First, Then M2|Sequence 1: M3 first then M2
38350|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
38351|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
38352|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
38277|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38278|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
38279|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
38280|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the SSC is specific to medication side effects, healthy controls did not complete the questionnaire.
38281|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38282|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the questionnaire is specific to epilepsy populations, and the side-effects to AEDs, healthy controls did not complete the QOLIE-89.
38283|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38284|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38285|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38286|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
38287|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
38288|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
38289|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38290|NCT02178995|O2|Outcome|Participants With Epilepsy (Double-blind Portion)|
38321|NCT02178995|E8|Reported Event|40mg, 20mg, Then Placebo (One Participant)|This study was originally intended to use 40mg, 20mg, and placebo doses rather than 20mg, 10mg, and placebo. This individual developed tachycardia (see adverse events) on the 40mg dose, and was withdrawn from the double-blind portion as a result. We removed the 40mg doses from this study and replaced them with 10mg doses. No other participant received a 40mg dose. This participant rejoined the open-label portion after consultation with his PCP due to significant perceived benefit from the MPH dose.
38291|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38292|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38293|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38294|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38295|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
38296|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38297|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|
38298|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38299|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38300|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38301|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
38302|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
38303|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38339|NCT02178787|E1|Reported Event|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
38340|NCT02178540|B1|Baseline|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
39240|NCT02171195|E4|Reported Event|Group 3 100 mg|BIA 2-093 100mg or placebo
38304|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38305|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
38306|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
38307|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38308|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
38309|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
38310|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
38311|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38312|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38313|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38314|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38315|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38316|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38317|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38318|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38319|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.
At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
38320|NCT02178995|E9|Reported Event|Healthy Controls|Healthy controls will complete the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but will not be exposed to study medication. They are included as a control group for the open-label phase of the study (visit 1 vs visit 5) only.
38341|NCT02178540|P1|Participant Flow|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
38322|NCT02178995|E7|Reported Event|20mg, Placebo, Then 10mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:
20mg of methylphenidate, Placebo, 10mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38323|NCT02178995|E6|Reported Event|20mg, 10mg, Then Placebo (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:
20mg of methylphenidate, 10mg of methylphenidate, Placebo.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38324|NCT02178995|E5|Reported Event|10mg, Placebo, Then 20mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:
10mg of methylphenidate, Placebo, 20mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38325|NCT02178995|E4|Reported Event|10mg, 20mg, Then Placebo (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:
10mg of methylphenidate, 20mg of methylphenidate, Placebo.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38326|NCT02178995|E3|Reported Event|Placebo, 10mg, Then 20mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:
Placebo, 10mg of methylphenidate, 20mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38327|NCT02178995|E2|Reported Event|Placebo, 20mg, Then 10mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:
Placebo, 20mg of methylphenidate, 10mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
38328|NCT02178995|E1|Reported Event|Participants With Epilepsy (Open-label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After a four week treatment trial, their scores on the batteries and questionnaires were again assessed.
38329|NCT02178787|B3|Baseline|Total|Total of all reporting groups
38330|NCT02178787|B2|Baseline|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
38331|NCT02178787|B1|Baseline|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
38332|NCT02178787|P2|Participant Flow|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
38333|NCT02178787|P1|Participant Flow|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
38334|NCT02178787|O2|Outcome|Non-diabetic Controls|Head-up tilt, vasoreactivity, standing up.
38335|NCT02178787|O1|Outcome|Type 2 Diabetes Mellitus|Head-up tilt, vasoreactivity, standing up.
38336|NCT02178787|O2|Outcome|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
38337|NCT02178787|O1|Outcome|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
38338|NCT02178787|E2|Reported Event|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
38355|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
38356|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
38357|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
38358|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
38359|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
38360|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
38361|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
38362|NCT02178059|E2|Reported Event|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
38363|NCT02178059|E1|Reported Event|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
38364|NCT02177266|B3|Baseline|Total|Total of all reporting groups
38365|NCT02177266|B2|Baseline|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
38366|NCT02177266|B1|Baseline|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
38367|NCT02177266|P2|Participant Flow|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
38368|NCT02177266|P1|Participant Flow|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
38369|NCT02177266|O2|Outcome|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
38370|NCT02177266|O1|Outcome|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
38371|NCT02177266|O2|Outcome|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
38372|NCT02177266|O1|Outcome|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
38373|NCT02177266|O2|Outcome|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
38374|NCT02177266|O1|Outcome|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
38375|NCT02177266|E2|Reported Event|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
38376|NCT02177266|E1|Reported Event|Placebo|A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.
38377|NCT02177201|B3|Baseline|Total|Total of all reporting groups
38378|NCT02177201|B2|Baseline|Group 2|Intravenous 20 ml/kg/h 0.9% saline solution
38379|NCT02177201|B1|Baseline|Group 1|Intravenous 10 ml/kg/h 0.9% saline solution
38380|NCT02177201|P2|Participant Flow|Group 2|Intravenous 20 ml/kg/h 0.9% saline solution
38381|NCT02177201|P1|Participant Flow|Group 1|Intravenous 10 ml/kg/h 0.9% saline solution
38382|NCT02177201|O2|Outcome|20 ml/kg/h 0.9% Saline Solution|"Group 2, intravenous 20 ml/kg/h 0.9% saline solution
0.9 saline solution : After induction , IV access was established and children were randomly allocated to receive: 20 ml/kg/h 0.9% saline solution during intraoperatively"
38383|NCT02177201|O1|Outcome|10 ml/kg/h 0.9 %Saline Solution|"Group 1, intravenous 10 ml/kg/h 0.9% saline solution ,
0.9 % saline solution: After induction, IV access was established and children were randomly allocated to receive Group 1, 10 ml/kg/h 0.9% saline solution ;"
38384|NCT02177201|E2|Reported Event|Group 2 Intravenous 20ml/kg/h 0.9 %Saline Solution|Group 2, intravenous 20 ml/kg/h 0.9% saline solution. After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.
38385|NCT02177201|E1|Reported Event|Group 1 Intravenous 10ml/kg/h 0.9 %Saline Solution|Group 1, intravenous 10 ml/kg/h 0.9% saline solution , After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.
38386|NCT02177032|B5|Baseline|Total|Total of all reporting groups
38387|NCT02177032|B4|Baseline|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
38388|NCT02177032|B3|Baseline|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
38389|NCT02177032|B2|Baseline|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
38390|NCT02177032|B1|Baseline|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
38419|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
38391|NCT02177032|P4|Participant Flow|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
38392|NCT02177032|P3|Participant Flow|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen
38393|NCT02177032|P2|Participant Flow|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
38394|NCT02177032|P1|Participant Flow|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
38395|NCT02177032|O2|Outcome|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
38396|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
38397|NCT02177032|O2|Outcome|2-sites TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
38398|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
38399|NCT02177032|O4|Outcome|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
38400|NCT02177032|O3|Outcome|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen
38401|NCT02177032|O2|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
38402|NCT02177032|O1|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
38403|NCT02177032|O4|Outcome|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
38404|NCT02177032|O3|Outcome|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
38405|NCT02177032|O2|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
38406|NCT02177032|O1|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
38407|NCT02177032|O2|Outcome|2-sites, TRC Without HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
38408|NCT02177032|O1|Outcome|4-sites, 1-week Without HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
38409|NCT02177032|O2|Outcome|2-sites, TRC Without HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
38410|NCT02177032|O1|Outcome|4-sites, 1-week Without HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
38411|NCT02177032|O2|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
38412|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
38413|NCT02177032|O2|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
38414|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen with HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
38415|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
38416|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1
38417|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
38418|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1
39241|NCT02171195|E3|Reported Event|Group 2 50 mg|BIA 2-093 50mg or placebo
38420|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1
38421|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
38422|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen with and without HRIG administered on day 1
38423|NCT02177032|E4|Reported Event|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
38424|NCT02177032|E3|Reported Event|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
38425|NCT02177032|E2|Reported Event|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
38426|NCT02177032|E1|Reported Event|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
38427|NCT02176655|B1|Baseline|Cross-Over Group|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
38428|NCT02176655|P1|Participant Flow|All Study Participants|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
38429|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo"
38430|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
38431|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
38432|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
38433|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
38434|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo"
38435|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
38436|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
38437|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo"
38438|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
38439|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo"
38440|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
38441|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo"
38442|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
38443|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo"
38444|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
38445|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo"
38482|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
40087|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
38446|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
38447|NCT02176655|E1|Reported Event|All Study Participants|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
38448|NCT02176525|B9|Baseline|Total|Total of all reporting groups
38449|NCT02176525|B8|Baseline|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38450|NCT02176525|B7|Baseline|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38451|NCT02176525|B6|Baseline|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38452|NCT02176525|B5|Baseline|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38453|NCT02176525|B4|Baseline|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38454|NCT02176525|B3|Baseline|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38455|NCT02176525|B2|Baseline|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38456|NCT02176525|B1|Baseline|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38457|NCT02176525|P8|Participant Flow|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38458|NCT02176525|P7|Participant Flow|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38459|NCT02176525|P6|Participant Flow|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38460|NCT02176525|P5|Participant Flow|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38461|NCT02176525|P4|Participant Flow|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38462|NCT02176525|P3|Participant Flow|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38463|NCT02176525|P2|Participant Flow|DBV 100mg Fibrosis|Deleobuvir (DBV) 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38464|NCT02176525|P1|Participant Flow|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38465|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38466|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38467|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38468|NCT02176525|O4|Outcome|DBV 400mg|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days. Subgroup of patients in fibrosis and in cirrhosis presented in one arm.
38469|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38470|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38471|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38472|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38473|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38474|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38475|NCT02176525|O4|Outcome|DBV 400mg|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days. Subgroup of patients in fibrosis and in cirrhosis presented in one arm.
38476|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38477|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38478|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38479|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38480|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38481|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
39242|NCT02171195|E2|Reported Event|Group 1 20 mg|BIA 2-093 20mg or placebo.
38483|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38484|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38485|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38486|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38487|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38488|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38489|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38490|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38491|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38492|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38493|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38494|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38495|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38496|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38497|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38498|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38499|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38500|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38501|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38502|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38503|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38504|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38505|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38506|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38507|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38508|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38509|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38510|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38511|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38512|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38513|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38514|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38515|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38516|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38517|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38518|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38519|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
39243|NCT02171195|E1|Reported Event|Placebo|Placebo, PLC
39244|NCT02170779|B3|Baseline|Total|Total of all reporting groups
38520|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38521|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38522|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38523|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38524|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38525|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38526|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38527|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38528|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38529|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38530|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38531|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38532|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38533|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38534|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38535|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38536|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38537|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38538|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38539|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38540|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38541|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38542|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38543|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38544|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38545|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38546|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38547|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38548|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38549|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38550|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38551|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38552|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38553|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38554|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38555|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38556|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38557|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
60124|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
38558|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38559|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38560|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38561|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38562|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38563|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38564|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38565|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38566|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38567|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38568|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38569|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38570|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38571|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38572|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38573|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38574|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38575|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38576|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38577|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38578|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38579|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38580|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38581|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38582|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38583|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38584|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38585|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38586|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38587|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38588|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38589|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38590|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38591|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38592|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38593|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38594|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38595|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
60125|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
38596|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38597|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38598|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38599|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38600|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38601|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38602|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38603|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38604|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38605|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38606|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38607|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38608|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38609|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38610|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38611|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38612|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38613|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38614|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38615|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38616|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38617|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38618|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38619|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38620|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38621|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38622|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38623|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38624|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38625|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38626|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38627|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38628|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38629|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38630|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38631|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38632|NCT02176525|E8|Reported Event|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38633|NCT02176525|E7|Reported Event|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
62973|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
38634|NCT02176525|E6|Reported Event|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38635|NCT02176525|E5|Reported Event|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
38636|NCT02176525|E4|Reported Event|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38637|NCT02176525|E3|Reported Event|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38638|NCT02176525|E2|Reported Event|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38639|NCT02176525|E1|Reported Event|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
38640|NCT02176421|B1|Baseline|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
38641|NCT02176421|P1|Participant Flow|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
38642|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
38643|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
38644|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
38645|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
38646|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
38647|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
38648|NCT02176421|E1|Reported Event|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
38649|NCT02176356|B1|Baseline|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38650|NCT02176356|P1|Participant Flow|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38651|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38652|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38653|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38654|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38655|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38656|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38657|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38811|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
39519|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
38822|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38658|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38659|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38660|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38661|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38662|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38663|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38664|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38665|NCT02176356|E1|Reported Event|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
38666|NCT02176343|B1|Baseline|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
38667|NCT02176343|P1|Participant Flow|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lens (IOL)
38668|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
38669|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
38670|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
38671|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
38672|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
38673|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
38674|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
38675|NCT02176343|O1|Outcome|ReSTOR Toric +2.5|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
38676|NCT02176343|E1|Reported Event|ReSTOR Toric +2.5|All subjects implanted with AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
38677|NCT02175771|B9|Baseline|Total|Total of all reporting groups
38678|NCT02175771|B8|Baseline|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38679|NCT02175771|B7|Baseline|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38680|NCT02175771|B6|Baseline|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38812|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38813|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38681|NCT02175771|B5|Baseline|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38682|NCT02175771|B4|Baseline|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38683|NCT02175771|B3|Baseline|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38684|NCT02175771|B2|Baseline|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38685|NCT02175771|B1|Baseline|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38686|NCT02175771|P9|Participant Flow|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38687|NCT02175771|P8|Participant Flow|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38688|NCT02175771|P7|Participant Flow|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38689|NCT02175771|P6|Participant Flow|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38690|NCT02175771|P5|Participant Flow|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38691|NCT02175771|P4|Participant Flow|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38692|NCT02175771|P3|Participant Flow|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38693|NCT02175771|P2|Participant Flow|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38694|NCT02175771|P1|Participant Flow|Enrolled Patients|During the run-in period, patients continued using their current asthma medications (ie, inhaled corticosteroid and/or other controller therapies) except for their short acting beta2-agonist (SABA), which was replaced by the sponsor-provided study rescue medication.
38695|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38814|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38815|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38696|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38697|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38698|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38699|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38700|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38701|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38702|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38703|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38704|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38705|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38706|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38707|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38708|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38709|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38710|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38816|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
62976|NCT01994720|E1|Reported Event|ASA 100mg|ASA 100 mg once daily (OD)
38711|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38712|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38713|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38714|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38715|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38716|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38717|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38718|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38719|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38720|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38721|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38722|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38723|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38724|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38725|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38817|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38726|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38727|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38728|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38729|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38730|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38731|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38732|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38733|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38734|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38735|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38736|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38737|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38738|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38739|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38740|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38818|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38741|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38742|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38743|NCT02175771|E8|Reported Event|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38744|NCT02175771|E7|Reported Event|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38745|NCT02175771|E6|Reported Event|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38746|NCT02175771|E5|Reported Event|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38747|NCT02175771|E4|Reported Event|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38748|NCT02175771|E3|Reported Event|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38749|NCT02175771|E2|Reported Event|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38750|NCT02175771|E1|Reported Event|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
38751|NCT02175745|B1|Baseline|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
38752|NCT02175745|P1|Participant Flow|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
38753|NCT02175745|O1|Outcome|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
38754|NCT02175745|O1|Outcome|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
38755|NCT02175745|E1|Reported Event|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
38756|NCT02175212|B3|Baseline|Total|Total of all reporting groups
38757|NCT02175212|B2|Baseline|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
- Bicalutamide 50 mg tablet every day for 2 months
Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38758|NCT02175212|B1|Baseline|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38819|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38759|NCT02175212|P2|Participant Flow|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
- Bicalutamide 50 mg tablet every day for 2 months
Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38760|NCT02175212|P1|Participant Flow|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38761|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
- Bicalutamide 50 mg tablet every day for 2 months
Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38762|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38763|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
- Bicalutamide 50 mg tablet every day for 2 months
Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38764|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38765|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
- Bicalutamide 50 mg tablet every day for 2 months
Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38766|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38767|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
- Bicalutamide 50 mg tablet every day for 2 months
Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38768|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38769|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
- Bicalutamide 50 mg tablet every day for 2 months
Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38770|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38771|NCT02175212|E2|Reported Event|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
- Bicalutamide 50 mg tablet every day for 2 months
Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38820|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38821|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38772|NCT02175212|E1|Reported Event|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
High dose conformal radiotherapy
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
38773|NCT02175199|B3|Baseline|Total|Total of all reporting groups
38774|NCT02175199|B2|Baseline|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
38775|NCT02175199|B1|Baseline|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
38776|NCT02175199|P2|Participant Flow|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
38777|NCT02175199|P1|Participant Flow|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
38778|NCT02175199|O2|Outcome|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
38779|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
38780|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
38781|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
38782|NCT02175199|E3|Reported Event|FreshLook COLORBLENDS|Includes all eyes exposed to FreshLook® COLORBLENDS® contact lenses
38783|NCT02175199|E2|Reported Event|AIR OPTIX COLORS|Includes all eyes exposed to AIR OPTIX® COLORS contact lenses
38784|NCT02175199|E1|Reported Event|Pre-treatment|Includes all subjects prior to the exposure to the investigational or control products
38785|NCT02175121|B6|Baseline|Total|Total of all reporting groups
38786|NCT02175121|B5|Baseline|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38787|NCT02175121|B4|Baseline|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38788|NCT02175121|B3|Baseline|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38789|NCT02175121|B2|Baseline|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38790|NCT02175121|B1|Baseline|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38791|NCT02175121|P5|Participant Flow|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38792|NCT02175121|P4|Participant Flow|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38793|NCT02175121|P3|Participant Flow|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38794|NCT02175121|P2|Participant Flow|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38795|NCT02175121|P1|Participant Flow|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38796|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38797|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38798|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38799|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38800|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38801|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38802|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38803|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38804|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38805|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38806|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38807|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38808|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38809|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38810|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38823|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38824|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38825|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38826|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38827|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38828|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38829|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38830|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38831|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38832|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38833|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38834|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38835|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38836|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38837|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38838|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38839|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38840|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38841|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38842|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38843|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38844|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38845|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38846|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38847|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38848|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38849|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38850|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38851|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38852|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38853|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38854|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38855|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38856|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38857|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38858|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38859|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38860|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38861|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38862|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
39613|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC
OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
38863|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38864|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38865|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38866|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38867|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38868|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38869|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38870|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38871|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38872|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38873|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38874|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38875|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38876|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38877|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38878|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38879|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38880|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38881|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38882|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38883|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38884|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38885|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38886|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38887|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38888|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38889|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38890|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38891|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38892|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38893|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38894|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38895|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38896|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38897|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38898|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38899|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38900|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38901|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38902|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
39520|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39521|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
38903|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38904|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38905|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38906|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38907|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38908|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38909|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38910|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38911|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38912|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38913|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38914|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38915|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38916|NCT02175121|E5|Reported Event|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
38917|NCT02175121|E4|Reported Event|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38918|NCT02175121|E3|Reported Event|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
38919|NCT02175121|E2|Reported Event|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
38920|NCT02175121|E1|Reported Event|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
38921|NCT02173769|B1|Baseline|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
38922|NCT02173769|P1|Participant Flow|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
38923|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
38924|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
38925|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
38926|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
38927|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
38928|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
38929|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
38930|NCT02173769|E2|Reported Event|Spiriva 18 mcg + Striverdi Respimat|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva 18 microgram plus Striverdi Respimat
38931|NCT02173769|E1|Reported Event|Spiriva Respimat + Striverdi Respimat|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat
38932|NCT02173535|B21|Baseline|Total|Total of all reporting groups
38933|NCT02173535|B20|Baseline|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38934|NCT02173535|B19|Baseline|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38935|NCT02173535|B18|Baseline|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38936|NCT02173535|B17|Baseline|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38937|NCT02173535|B16|Baseline|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38938|NCT02173535|B15|Baseline|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
39522|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
38939|NCT02173535|B14|Baseline|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38940|NCT02173535|B13|Baseline|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38941|NCT02173535|B12|Baseline|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38942|NCT02173535|B11|Baseline|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38943|NCT02173535|B10|Baseline|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38944|NCT02173535|B9|Baseline|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38945|NCT02173535|B8|Baseline|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38946|NCT02173535|B7|Baseline|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38947|NCT02173535|B6|Baseline|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38948|NCT02173535|B5|Baseline|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38949|NCT02173535|B4|Baseline|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38950|NCT02173535|B3|Baseline|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38951|NCT02173535|B2|Baseline|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38952|NCT02173535|B1|Baseline|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38953|NCT02173535|P20|Participant Flow|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38954|NCT02173535|P19|Participant Flow|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38955|NCT02173535|P18|Participant Flow|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38956|NCT02173535|P17|Participant Flow|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38957|NCT02173535|P16|Participant Flow|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38958|NCT02173535|P15|Participant Flow|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38959|NCT02173535|P14|Participant Flow|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38960|NCT02173535|P13|Participant Flow|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38961|NCT02173535|P12|Participant Flow|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38962|NCT02173535|P11|Participant Flow|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38963|NCT02173535|P10|Participant Flow|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38964|NCT02173535|P9|Participant Flow|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38965|NCT02173535|P8|Participant Flow|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38966|NCT02173535|P7|Participant Flow|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38967|NCT02173535|P6|Participant Flow|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38968|NCT02173535|P5|Participant Flow|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38969|NCT02173535|P4|Participant Flow|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38970|NCT02173535|P3|Participant Flow|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
39523|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39524|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
38971|NCT02173535|P2|Participant Flow|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38972|NCT02173535|P1|Participant Flow|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38973|NCT02173535|O5|Outcome|VC- Etafilcon A|Subjects that wore the VC investigational lens during any of the 5 period of the study.
38974|NCT02173535|O4|Outcome|LA-etafilcon A|Subjects that wore the LA investigational lens during any of the 5 period of the study.
38975|NCT02173535|O3|Outcome|JG-etafilcon A|Subjects that wore the JG investigational lens during any of the 5 period of the study.
38976|NCT02173535|O2|Outcome|CS- Etafilcon A|Subjects that wore the CS investigational lens during any of the 5 period of the study.
38977|NCT02173535|O1|Outcome|AP- Etafilcon A|Subjects that wore the AP investigational lens during any of the 5 period of the study.
38978|NCT02173535|O5|Outcome|VC- Etafilcon A|Subjects that wore the VC investigational lens during any of the 5 period of the study.
38979|NCT02173535|O4|Outcome|LA-etafilcon A|Subjects that wore the LA investigational lens during any of the 5 period of the study.
38980|NCT02173535|O3|Outcome|JG-etafilcon A|Subjects that wore the JG investigational lens during any of the 5 period of the study.
38981|NCT02173535|O2|Outcome|CS- Etafilcon A|Subjects that wore the CS investigational lens during any of the 5 period of the study.
38982|NCT02173535|O1|Outcome|AP- Etafilcon A|Subjects that wore the AP investigational lens during any of the 5 period of the study.
38983|NCT02173535|O5|Outcome|VC- Etafilcon A|Subjects that wore the VC investigational lens during any of the 5 period of the study.
38984|NCT02173535|O4|Outcome|LA-etafilcon A|Subjects that wore the LA investigational lens during any of the 5 period of the study.
38985|NCT02173535|O3|Outcome|JG-etafilcon A|Subjects that wore the JG investigational lens during any of the 5 period of the study.
38986|NCT02173535|O2|Outcome|CS- Etafilcon A|Subjects that wore the CS investigational lens during any of the 5 period of the study.
38987|NCT02173535|O1|Outcome|AP- Etafilcon A|Subjects that wore the AP investigational lens during any of the 5 period of the study.
38988|NCT02173535|E20|Reported Event|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38989|NCT02173535|E19|Reported Event|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38990|NCT02173535|E18|Reported Event|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38991|NCT02173535|E17|Reported Event|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38992|NCT02173535|E16|Reported Event|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38993|NCT02173535|E15|Reported Event|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38994|NCT02173535|E14|Reported Event|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38995|NCT02173535|E13|Reported Event|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38996|NCT02173535|E12|Reported Event|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38997|NCT02173535|E11|Reported Event|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38998|NCT02173535|E10|Reported Event|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
38999|NCT02173535|E9|Reported Event|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
39000|NCT02173535|E8|Reported Event|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
39001|NCT02173535|E7|Reported Event|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
39002|NCT02173535|E6|Reported Event|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
39003|NCT02173535|E5|Reported Event|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
39004|NCT02173535|E4|Reported Event|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
39005|NCT02173535|E3|Reported Event|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
39006|NCT02173535|E2|Reported Event|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
39007|NCT02173535|E1|Reported Event|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
39008|NCT02173392|B3|Baseline|Total|Total of all reporting groups
39009|NCT02173392|B2|Baseline|(Treatment B Days 1-28 + Treatment 8 Days 29-56)|"210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28]) first, then Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39010|NCT02173392|B1|Baseline|(Treatment A Day 1-28 + Treatment B Day 29-56)|"210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28) first, then followed by Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39011|NCT02173392|P2|Participant Flow|(Treatment B Days 1-28 + Treatment A Days 29-56)|"210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28]) first, then Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39012|NCT02173392|P1|Participant Flow|(Treatment A Day 1-28 + Treatment B Day 29-56)|"210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28) first, then followed by Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39013|NCT02173392|O2|Outcome|Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39014|NCT02173392|O1|Outcome|Brodalumab (Single 1.5mL Pre-filled Syringe)|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39015|NCT02173392|O2|Outcome|Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39016|NCT02173392|O1|Outcome|Brodalumab (Single 1.5mL Pre-filled Syringe)|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39017|NCT02173392|O2|Outcome|Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39018|NCT02173392|O1|Outcome|Treatment A, Brodalumab (Single 1.5mL Pre-filled Syringe)|"A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39019|NCT02173392|E2|Reported Event|(Treatment B Days 1-28 + Treatment A Days 29-56)|"210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28]) first, then Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39020|NCT02173392|E1|Reported Event|(Treatment A Day 1-28 + Treatment B Day 29-56)|"210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28) first, then followed by Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases"
39021|NCT02173054|B4|Baseline|Total|Total of all reporting groups
39022|NCT02173054|B3|Baseline|Adapalene Gel With Eucerin|"Morning
Wash face by prepared facial foam and dry their face
Apply Eucerin cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply Eucerin cream all over the face
Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39023|NCT02173054|B2|Baseline|Adapalene Gel With Placebo Moisturizer|"Morning
Wash face by prepared facial foam and dry their face
Apply placebo cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply placebo cream all over the face
Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39024|NCT02173054|B1|Baseline|Adapalene Gel|"Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39025|NCT02173054|P3|Participant Flow|Adapalene Gel With Eucerin|"Morning
Wash face by prepared facial foam and dry their face
Apply Eucerin cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply Eucerin cream all over the face
Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39026|NCT02173054|P2|Participant Flow|Adapalene Gel With Placebo Moisturizer|"Morning
Wash face by prepared facial foam and dry their face
Apply placebo cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply placebo cream all over the face
Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39027|NCT02173054|P1|Participant Flow|Adapalene Gel|"Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39028|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning
Wash face by prepared facial foam and dry their face
Apply Eucerin cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply Eucerin cream all over the face
Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39029|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning
Wash face by prepared facial foam and dry their face
Apply placebo cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply placebo cream all over the face
Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39030|NCT02173054|O1|Outcome|Adapalene Gel|"Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39031|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning
Wash face by prepared facial foam and dry their face
Apply Eucerin cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply Eucerin cream all over the face
Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39032|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning
Wash face by prepared facial foam and dry their face
Apply placebo cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply placebo cream all over the face
Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39033|NCT02173054|O1|Outcome|Adapalene Gel|"Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39034|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning
Wash face by prepared facial foam and dry their face
Apply Eucerin cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply Eucerin cream all over the face
Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39035|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning
Wash face by prepared facial foam and dry their face
Apply placebo cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply placebo cream all over the face
Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39036|NCT02173054|O1|Outcome|Adapalene Gel|"Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39037|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning
Wash face by prepared facial foam and dry their face
Apply Eucerin cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply Eucerin cream all over the face
Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39038|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning
Wash face by prepared facial foam and dry their face
Apply placebo cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply placebo cream all over the face
Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39039|NCT02173054|O1|Outcome|Adapalene Gel|"Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39040|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning
Wash face by prepared facial foam and dry their face
Apply Eucerin cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply Eucerin cream all over the face
Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39041|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning
Wash face by prepared facial foam and dry their face
Apply placebo cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply placebo cream all over the face
Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39042|NCT02173054|O1|Outcome|Adapalene Gel|"Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39043|NCT02173054|E3|Reported Event|Adapalene Gel With Eucerin|"Morning
Wash face by prepared facial foam and dry their face
Apply Eucerin cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply Eucerin cream all over the face
Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39044|NCT02173054|E2|Reported Event|Adapalene Gel With Placebo Moisturizer|"Morning
Wash face by prepared facial foam and dry their face
Apply placebo cream all over the face
Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Apply placebo cream all over the face
Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39045|NCT02173054|E1|Reported Event|Adapalene Gel|"Evening
Wash face by prepared facial foam and dry your face
Apply adapalene gel all over the face
Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
39046|NCT02172755|B3|Baseline|Total|Total of all reporting groups
39047|NCT02172755|B2|Baseline|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39048|NCT02172755|B1|Baseline|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39112|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39525|NCT02169479|E4|Reported Event|Placebo|Placebo, PLC
62977|NCT01994629|B3|Baseline|Total|Total of all reporting groups
39049|NCT02172755|P2|Participant Flow|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39050|NCT02172755|P1|Participant Flow|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39051|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39052|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39053|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39054|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39055|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39056|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39057|NCT02172755|E2|Reported Event|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39058|NCT02172755|E1|Reported Event|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
39059|NCT02172742|B3|Baseline|Total|Total of all reporting groups
39060|NCT02172742|B2|Baseline|Placebo + BIA 2-093|"Period 1:
Placebo with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
Period 2:
BIA 2-093 1200 mg with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
39061|NCT02172742|B1|Baseline|BIA 2-093 + Placebo|"Period 1:
BIA 2-093 1200 mg with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
Period 2:
Placebo with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
39062|NCT02172742|P2|Participant Flow|Placebo + BIA 2-093|"Period 1:
Placebo with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
Period 2:
BIA 2-093 1200 mg with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
39063|NCT02172742|P1|Participant Flow|BIA 2-093 + Placebo|"Period 1:
BIA 2-093 1200 mg with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
Period 2:
Placebo with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
39064|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:
Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
39065|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:
Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
39066|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:
Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
39067|NCT02172742|E2|Reported Event|Placebo+Digoxin|Placebo + Digoxin
39068|NCT02172742|E1|Reported Event|BIA 2-093+Digoxin|BIA 2-093 + Digoxin
39069|NCT02172625|B3|Baseline|Total|Total of all reporting groups
39113|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39526|NCT02169479|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39070|NCT02172625|B2|Baseline|Protandim Dietary Supplement|"Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
39071|NCT02172625|B1|Baseline|Sugar Pill|"Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator
Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
39072|NCT02172625|P2|Participant Flow|Protandim Dietary Supplement|"Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
39073|NCT02172625|P1|Participant Flow|Sugar Pill|"Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator
Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
39074|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
39075|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
39076|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
39077|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
39078|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
39079|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
39080|NCT02172625|O2|Outcome|Protandim Group|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
39081|NCT02172625|O1|Outcome|Placebo Group|"Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
39082|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
39083|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
39084|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contained 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
39085|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
39086|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
39087|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
39088|NCT02172625|E2|Reported Event|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
39089|NCT02172625|E1|Reported Event|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
39090|NCT02171611|B1|Baseline|Overall|This study is open-label, single dose, randomised, three-way crossover design having 3 treatment periods ie., Dabigatran etexilate 150 mg formulation capsule: Reference (A), Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) and Dabigatran etexilate 150 mg formulation powder: Test 2 (C)
39091|NCT02171611|P6|Participant Flow|C/B/A|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in Period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water.
Treatments were separated by washout period of at least 7 days after drug administration."
39165|NCT02171247|B1|Baseline|Visipaque 320|"Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol."
39092|NCT02171611|P5|Participant Flow|C/A/B|Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject. Treatments were separated by washout period of at least 7 days after drug administration.
39093|NCT02171611|P4|Participant Flow|B/C/A|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water.
Treatments were separated by washout period of at least 7 days after drug administration."
39094|NCT02171611|P3|Participant Flow|B/A/C|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution.
Treatments were separated by washout period of at least 7 days after drug administration."
39095|NCT02171611|P2|Participant Flow|A/C/B|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject.
Treatments were separated by washout period of at least 7 days after drug administration."
39096|NCT02171611|P1|Participant Flow|A/B/C|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in Period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution.
Treatments were separated by washout period of at least 7 days after drug administration."
39097|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39098|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39099|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39100|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39101|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39102|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39103|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39104|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39105|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39106|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39107|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39108|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39109|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39110|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39111|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39226|NCT02171195|O9|Outcome|Group 8 1200 mg|BIA 2-093 1200mg or placebo
39114|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39115|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39116|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39117|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39118|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39119|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39120|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39121|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39122|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39123|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39124|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39125|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39126|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39127|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39128|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39129|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39130|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39131|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39132|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39133|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39134|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39135|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39136|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39137|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39138|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39139|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39140|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39141|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39142|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39143|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39144|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39145|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39146|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39147|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39148|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39149|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39150|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39151|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39152|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39153|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39154|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39155|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39156|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39157|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39158|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39159|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39160|NCT02171611|E3|Reported Event|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
39161|NCT02171611|E2|Reported Event|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
39162|NCT02171611|E1|Reported Event|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
39163|NCT02171247|B3|Baseline|Total|Total of all reporting groups
39164|NCT02171247|B2|Baseline|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
39166|NCT02171247|P2|Participant Flow|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
39167|NCT02171247|P1|Participant Flow|Visipaque 320|"Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol."
39168|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
39169|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol."
39170|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
39171|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol."
39172|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
39173|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol."
39174|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
39175|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol."
39176|NCT02171247|E2|Reported Event|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.
Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
39177|NCT02171247|E1|Reported Event|Visipaque 320|"Standard protocol is Visipaque 320.
Visipaque 320: Visipaque 320 is standard protocol."
39178|NCT02171234|B6|Baseline|Total|Total of all reporting groups
39179|NCT02171234|B5|Baseline|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
39180|NCT02171234|B4|Baseline|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
39181|NCT02171234|B3|Baseline|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
39182|NCT02171234|B2|Baseline|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
39183|NCT02171234|B1|Baseline|Placebo|PLC, Placebo
39184|NCT02171234|P5|Participant Flow|Group 4 - 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 1200mg
39185|NCT02171234|P4|Participant Flow|Group 3 - 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 800mg
39186|NCT02171234|P3|Participant Flow|Group 2 - 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 400mg
39187|NCT02171234|P2|Participant Flow|Group 1 - 200 mg b.i.d.|BIA 2-093 200mg (twice daily)
39188|NCT02171234|P1|Participant Flow|Placebo|PLC, Placebo
39189|NCT02171234|O5|Outcome|Placebo|PLC, Placebo
39190|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
39191|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
39192|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
39193|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
39194|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
39195|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
39196|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
39197|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
39198|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
39199|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
39200|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
39201|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
39202|NCT02171234|E5|Reported Event|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
39203|NCT02171234|E4|Reported Event|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
39204|NCT02171234|E3|Reported Event|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
39205|NCT02171234|E2|Reported Event|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
39206|NCT02171234|E1|Reported Event|Placebo|PLC, Placebo
39207|NCT02171195|B10|Baseline|Total|Total of all reporting groups
39208|NCT02171195|B9|Baseline|Group 8 1200 mg|BIA 2-093 1200mg or placebo
39209|NCT02171195|B8|Baseline|Group 7 900 mg|BIA 2-093 900mg or placebo
39210|NCT02171195|B7|Baseline|Group 6 600 mg|BIA 2-093 600mg or placebo
39211|NCT02171195|B6|Baseline|Group 5 400 mg|BIA 2-093 or 400mg or placebo
39212|NCT02171195|B5|Baseline|Group 4 200 mg|BIA 2-093 200mg or placebo
39213|NCT02171195|B4|Baseline|Group 3 100 mg|BIA 2-093 100mg or placebo
39214|NCT02171195|B3|Baseline|Group 2 50 mg|BIA 2-093 50mg or placebo
39215|NCT02171195|B2|Baseline|Group 1 20 mg|BIA 2-093 20mg or placebo.
39216|NCT02171195|B1|Baseline|Placebo|Placebo, PLC
39217|NCT02171195|P9|Participant Flow|Group 8 1200 mg|BIA 2-093 1200mg or placebo
39218|NCT02171195|P8|Participant Flow|Group 7 900 mg|BIA 2-093 900mg or placebo
39219|NCT02171195|P7|Participant Flow|Group 6 600 mg|BIA 2-093 600mg or placebo
39220|NCT02171195|P6|Participant Flow|Group 5 400 mg|BIA 2-093 or 400mg or placebo
39221|NCT02171195|P5|Participant Flow|Group 4 200 mg|BIA 2-093 200mg or placebo
39222|NCT02171195|P4|Participant Flow|Group 3 100 mg|BIA 2-093 100mg or placebo
39223|NCT02171195|P3|Participant Flow|Group 2 50 mg|BIA 2-093 50mg or placebo
39224|NCT02171195|P2|Participant Flow|Group 1 20 mg|BIA 2-093 20mg or placebo.
39225|NCT02171195|P1|Participant Flow|Placebo|Placebo, PLC
39245|NCT02170779|B2|Baseline|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39246|NCT02170779|B1|Baseline|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39247|NCT02170779|P2|Participant Flow|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39248|NCT02170779|P1|Participant Flow|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39249|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39250|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39251|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39252|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39253|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39254|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39255|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39256|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39257|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39258|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39259|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39260|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39261|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39262|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39263|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39264|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39265|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39266|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39267|NCT02170779|E2|Reported Event|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
39268|NCT02170779|E1|Reported Event|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
39269|NCT02170688|B6|Baseline|Total|Total of all reporting groups
39270|NCT02170688|B5|Baseline|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39294|NCT02170688|E1|Reported Event|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
39295|NCT02170662|B3|Baseline|Total|Total of all reporting groups
63620|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
39271|NCT02170688|B4|Baseline|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39272|NCT02170688|B3|Baseline|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39273|NCT02170688|B2|Baseline|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39274|NCT02170688|B1|Baseline|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
39275|NCT02170688|P5|Participant Flow|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39276|NCT02170688|P4|Participant Flow|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39277|NCT02170688|P3|Participant Flow|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39278|NCT02170688|P2|Participant Flow|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39279|NCT02170688|P1|Participant Flow|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
39280|NCT02170688|O5|Outcome|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39281|NCT02170688|O4|Outcome|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39296|NCT02170662|B2|Baseline|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were randomized to apply placebo topically for 16 weeks."
39527|NCT02169479|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
63621|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
39282|NCT02170688|O3|Outcome|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39283|NCT02170688|O2|Outcome|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39284|NCT02170688|O1|Outcome|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
39285|NCT02170688|O5|Outcome|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39286|NCT02170688|O4|Outcome|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39287|NCT02170688|O3|Outcome|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39288|NCT02170688|O2|Outcome|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39289|NCT02170688|O1|Outcome|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
39290|NCT02170688|E5|Reported Event|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39291|NCT02170688|E4|Reported Event|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39292|NCT02170688|E3|Reported Event|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.
Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
39293|NCT02170688|E2|Reported Event|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).
Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Weight calculation"
63622|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
39297|NCT02170662|B1|Baseline|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
39298|NCT02170662|P2|Participant Flow|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were randomized to apply placebo topically for 16 weeks."
39299|NCT02170662|P1|Participant Flow|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
39300|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were randomized to apply placebo topically for 16 weeks."
39301|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
39302|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were randomized to apply placebo topically for 16 weeks."
39303|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
39304|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were randomized to apply placebo topically for 16 weeks."
39305|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
39306|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were randomized to apply placebo topically for 16 weeks."
39307|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
39308|NCT02170662|E2|Reported Event|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were randomized to apply placebo topically for 16 weeks."
39309|NCT02170662|E1|Reported Event|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
39310|NCT02170649|B1|Baseline|Fasting Period|single 800 mg oral dose of BIA 2-093 following 10 hours of fasting or following either a standard high fat content breakfast.
39311|NCT02170649|P1|Participant Flow|BIA 2-093 (Fasting & Fed)|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
39312|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
39313|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
39314|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
39315|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
39316|NCT02170649|E1|Reported Event|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
39317|NCT02170532|B1|Baseline|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
39318|NCT02170532|P1|Participant Flow|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
39319|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
levalbuterol MDI
aerochamber max"
39320|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs
levalbuterol MDI
aerochamber max"
39321|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs
levalbuterol MDI"
39322|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
levalbuterol: 0.5 ml. levalbuterol
breath actuated nebulizer
ipratroprium"
39323|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
levalbuterol: 0.5 ml. levalbuterol
saline: 0.5ml saline
breath actuated nebulizer"
39324|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
levalbuterol MDI
aerochamber max"
39325|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs
levalbuterol MDI
aerochamber max"
39326|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs
levalbuterol MDI"
39327|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
levalbuterol: 0.5 ml. levalbuterol
breath actuated nebulizer
ipratroprium"
39328|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
levalbuterol: 0.5 ml. levalbuterol
saline: 0.5ml saline
breath actuated nebulizer"
39329|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
levalbuterol MDI
aerochamber max"
39330|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs
levalbuterol MDI
aerochamber max"
39331|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs
levalbuterol MDI"
39332|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
levalbuterol: 0.5 ml. levalbuterol
breath actuated nebulizer
ipratroprium"
39333|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
levalbuterol: 0.5 ml. levalbuterol
saline: 0.5ml saline
breath actuated nebulizer"
39334|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
levalbuterol MDI
aerochamber max"
39335|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs
levalbuterol MDI
aerochamber max"
39336|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs
levalbuterol MDI"
39337|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
levalbuterol: 0.5 ml. levalbuterol
breath actuated nebulizer
ipratroprium"
39338|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
levalbuterol: 0.5 ml. levalbuterol
saline: 0.5ml saline
breath actuated nebulizer"
39339|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol metered dose inhaler (MDI) + aerochamber max with 2 second pause 2 puffs
levalbuterol MDI
aerochamber max"
39340|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol metered-dose inhaler (MDI) + aerochamber max without pause 2 puffs
levalbuterol MDI
aerochamber max"
39341|NCT02170532|O3|Outcome|Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs|"levalbuterol metered dose inhaler (MDI) 2 puffs
levalbuterol MDI"
39342|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
levalbuterol: 0.5 ml. levalbuterol
breath actuated nebulizer
ipratroprium"
39343|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
levalbuterol: 0.5 ml. levalbuterol
saline: 0.5ml saline
breath actuated nebulizer"
39344|NCT02170532|E1|Reported Event|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
39345|NCT02170519|B3|Baseline|Total|Total of all reporting groups
39346|NCT02170519|B2|Baseline|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39347|NCT02170519|B1|Baseline|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39348|NCT02170519|P2|Participant Flow|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39349|NCT02170519|P1|Participant Flow|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39361|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39350|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39351|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39352|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39353|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39354|NCT02170519|O2|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39355|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39356|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39357|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39358|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39359|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39360|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39408|NCT02170376|E2|Reported Event|Group 2|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39528|NCT02169479|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39362|NCT02170519|E2|Reported Event|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39363|NCT02170519|E1|Reported Event|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
39364|NCT02170376|B6|Baseline|Total|Total of all reporting groups
39365|NCT02170376|B5|Baseline|Group 5|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39366|NCT02170376|B4|Baseline|Group 4|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39367|NCT02170376|B3|Baseline|Group 3|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39368|NCT02170376|B2|Baseline|Group 2|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39369|NCT02170376|B1|Baseline|Group 1|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12
Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39370|NCT02170376|P5|Participant Flow|Group 5: Placebo Then Levodopa/Carbidopa|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39371|NCT02170376|P4|Participant Flow|Group 4: BIA 75 mg Then Placebo/Levodopa/Carbidopa|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39372|NCT02170376|P3|Participant Flow|Group 3: BIA 50 mg Then Placebo/Levodopa/Carbidopa|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39373|NCT02170376|P2|Participant Flow|Group 2: BIA 25 mg Then Placebo/Levodopa/Carbidopa|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39374|NCT02170376|P1|Participant Flow|Group 1: Placebo Then Entacapone/Levodopa|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12
Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39375|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
39376|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
39377|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
39378|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
39379|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
39380|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
39381|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
39382|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
39383|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
39384|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
39385|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
39386|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
39387|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
39388|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
39389|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
39390|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
39391|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
39392|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
39393|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
39394|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
39395|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
39396|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
39397|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
39398|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
39399|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
39400|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
39401|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
39402|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
39403|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
39404|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
39405|NCT02170376|E5|Reported Event|Group 5|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39406|NCT02170376|E4|Reported Event|Group 4|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39407|NCT02170376|E3|Reported Event|Group 3|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39409|NCT02170376|E1|Reported Event|Group 1|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12
Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
39410|NCT02170220|B3|Baseline|Total|Total of all reporting groups
39411|NCT02170220|B2|Baseline|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39412|NCT02170220|B1|Baseline|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39413|NCT02170220|P2|Participant Flow|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39414|NCT02170220|P1|Participant Flow|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39415|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39416|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39417|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39418|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39419|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39420|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39421|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39422|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39423|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39424|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39425|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39426|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39427|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39428|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39429|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39430|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39431|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39432|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39433|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39434|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39435|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39436|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39437|NCT02170220|E2|Reported Event|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
39438|NCT02170220|E1|Reported Event|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
39439|NCT02170207|B1|Baseline|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
39440|NCT02170207|P1|Participant Flow|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
39441|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
39442|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
39443|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
39444|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
39445|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
39516|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39446|NCT02170207|E1|Reported Event|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
39447|NCT02170077|B4|Baseline|Total|Total of all reporting groups
39448|NCT02170077|B3|Baseline|PLG – Placebo Group|"placebo
Placebo: Placebo tablets administered orally"
39449|NCT02170077|B2|Baseline|TDG - Twice-daily Group|"BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
39450|NCT02170077|B1|Baseline|ODG - Once-daily Group|"BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
39451|NCT02170077|P3|Participant Flow|PLG – Placebo Group|"placebo
Placebo: Placebo tablets administered orally"
39452|NCT02170077|P2|Participant Flow|TDG - Twice-daily Group|"BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
39453|NCT02170077|P1|Participant Flow|ODG - Once-daily Group|"BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
39454|NCT02170077|O3|Outcome|PLG - Placebo Group|Intent to treat (TT) Population
39455|NCT02170077|O2|Outcome|TDG - Twice Daily Group|Intent to treat (TT) Population
39456|NCT02170077|O1|Outcome|ODG - Once Daily Group|Intent to treat (TT) Population
39457|NCT02170077|E3|Reported Event|PLG - Placebo Group|Intent to treat (TT) Population
39458|NCT02170077|E2|Reported Event|TDG - Twice Daily Group|Intent to treat (TT) Population
39459|NCT02170077|E1|Reported Event|ODG - Once Daily Group|Intent to treat (TT) Population
39460|NCT02170064|B4|Baseline|Total|Total of all reporting groups
39461|NCT02170064|B3|Baseline|Group 3 (12-17 Yrs)|Efficacy population (EP)
39462|NCT02170064|B2|Baseline|Group 2 (7-11 Yrs)|Efficacy population (EP)
39463|NCT02170064|B1|Baseline|Group 1 (2-6 Yrs)|Efficacy population (EP)
39464|NCT02170064|P3|Participant Flow|Group 3 (12-17 Years)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.
For Group 2 (7–11 years) and Group 3 (12–17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored)."
39465|NCT02170064|P2|Participant Flow|Group 2 (7-11 Years)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.
For Group 2 (7–11 years) and Group 3 (12–17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored)."
39466|NCT02170064|P1|Participant Flow|Group 1 (2-6 Yrs)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.
For Group 1 (2–6 years), oral suspension 50 mg/mL was used. The dose was to be rounded to the nearest 25 mg unit."
39467|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
39468|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
39469|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
39470|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
39471|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
39472|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
39473|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
39474|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
39475|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
39476|NCT02170064|E3|Reported Event|Group 3 (12-17 Yrs)|Safety population (SP)
39477|NCT02170064|E2|Reported Event|Group 2 (7-11 Yrs)|Safety population (SP)
39478|NCT02170064|E1|Reported Event|Group 1 (2-6 Yrs)|Safety population (SP)
39479|NCT02169895|B5|Baseline|Total|Total of all reporting groups
39480|NCT02169895|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
Every period with concomitant single oral administration of Prolopa® 100-25"
39481|NCT02169895|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
Every period with concomitant single oral administration of Prolopa® 100-25"
39482|NCT02169895|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
Every period with concomitant single oral administration of Prolopa® 100-25"
39517|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
39518|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39483|NCT02169895|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
Every period with concomitant single oral administration of Prolopa® 100-25"
39484|NCT02169895|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
Every period with concomitant single oral administration of Prolopa® 100-25
Prolopa®: levodopa/benserazide 100/25 mg"
39485|NCT02169895|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
Every period with concomitant single oral administration of Prolopa® 100-25
Prolopa®: levodopa/benserazide 100/25 mg"
39486|NCT02169895|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
Every period with concomitant single oral administration of Prolopa® 100-25
Prolopa®: levodopa/benserazide 100/25 mg"
39487|NCT02169895|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
Every period with concomitant single oral administration of Prolopa® 100-25
Prolopa®: levodopa/benserazide 100/25 mg"
39488|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.
with concomitant single oral administration of Prolopa® 100-25"
39489|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39490|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39491|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39492|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.
with concomitant single oral administration of Prolopa® 100-25"
39493|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39494|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39495|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39496|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.
with concomitant single oral administration of Prolopa® 100-25"
39497|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39498|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39499|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39500|NCT02169895|E4|Reported Event|Placebo Group|"Placebo Group.
with concomitant single oral administration of Prolopa® 100-25"
39501|NCT02169895|E3|Reported Event|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39502|NCT02169895|E2|Reported Event|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39503|NCT02169895|E1|Reported Event|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.
with concomitant single oral administration of Prolopa® 100-25"
39504|NCT02169479|B5|Baseline|Total|Total of all reporting groups
39505|NCT02169479|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
39506|NCT02169479|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
39507|NCT02169479|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
39508|NCT02169479|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
39509|NCT02169479|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
39510|NCT02169479|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
39511|NCT02169479|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
39512|NCT02169479|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
39513|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
39514|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39515|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39530|NCT02169466|B4|Baseline|BIA 9-1067: Placebo, 25, 50, 100|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
39531|NCT02169466|B3|Baseline|BIA 9-1067: 100, Placebo, 25, 50|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
39532|NCT02169466|B2|Baseline|BIA 9-1067: 50, 100, Placebo, 25|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
39533|NCT02169466|B1|Baseline|BIA 9-1067: 25, 50, 100, Placebo|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
39534|NCT02169466|P4|Participant Flow|BIA 9-1067: Placebo, 25, 50, 100|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
39535|NCT02169466|P3|Participant Flow|BIA 9-1067: 100, Placebo, 25, 50|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
39536|NCT02169466|P2|Participant Flow|BIA 9-1067: 50, 100, Placebo, 25|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
39537|NCT02169466|P1|Participant Flow|BIA 9-1067: 25, 50, 100, Placebo|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
39538|NCT02169466|O4|Outcome|Placebo|Placebo, PLC
39539|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39540|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39541|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39542|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
39543|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39544|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39545|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
39546|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
39547|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39548|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39549|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
39550|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
39551|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39552|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39553|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
39554|NCT02169466|E4|Reported Event|Placebo|Placebo, PLC
39555|NCT02169466|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39556|NCT02169466|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39557|NCT02169466|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39558|NCT02169453|B5|Baseline|Total|Total of all reporting groups
39559|NCT02169453|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
39560|NCT02169453|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
39612|NCT02169427|P1|Participant Flow|Opicapone (OPC)|"100 mg OPC
OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
39561|NCT02169453|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
39562|NCT02169453|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
39563|NCT02169453|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
39564|NCT02169453|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
39565|NCT02169453|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
39566|NCT02169453|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
39567|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
39568|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39569|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39570|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39571|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
39572|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39573|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39574|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39575|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
39576|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39577|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39578|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39579|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
39580|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39581|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39582|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39583|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
39584|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39585|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39586|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39587|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
39588|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39589|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39590|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39591|NCT02169453|E4|Reported Event|Placebo|Placebo, PLC
39592|NCT02169453|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
39593|NCT02169453|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
39594|NCT02169453|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
39595|NCT02169440|B3|Baseline|Total|Total of all reporting groups
39596|NCT02169440|B2|Baseline|Group 2: Warfarin, Then BIA 9-1067 + Warfarin|"Period 1: warfarin Period 2: BIA 9-1067 + warfarin
BIA 9-1067: BIA 9-1067 25 mg
Warfarin: Warfarin 25 mg"
39597|NCT02169440|B1|Baseline|Group 1: BIA 9-1067 + Warfarin, Then Warfarin|"Period 1: BIA 9-1067 + warfarin Period 2: warfarin
BIA 9-1067: BIA 9-1067 25 mg
Warfarin: Warfarin 25 mg"
39598|NCT02169440|P2|Participant Flow|Group 2: Warfarin, Then BIA 9-1067 + Warfarin|"Period 1: warfarin Period 2: BIA 9-1067 + warfarin
BIA 9-1067: BIA 9-1067 25 mg
Warfarin: Warfarin 25 mg"
39599|NCT02169440|P1|Participant Flow|Group 1: BIA 9-1067 + Warfarin, Then Warfarin|"Period 1: BIA 9-1067 + warfarin Period 2: warfarin
BIA 9-1067: BIA 9-1067 25 mg
Warfarin: Warfarin 25 mg"
39600|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
39601|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
39602|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
39603|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
39604|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
39605|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
39606|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
39607|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
39608|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
39609|NCT02169440|E2|Reported Event|Warfarin|Warfarin 25 mg
39610|NCT02169440|E1|Reported Event|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg Warfarin 25 mg
39611|NCT02169427|B1|Baseline|Opicapone (OPC)|"100 mg OPC
OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
40084|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
39614|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC
OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
39615|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC
OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
39616|NCT02169427|E1|Reported Event|Opicapone (OPC)|"100 mg OPC
OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
39617|NCT02169414|B5|Baseline|Total|Total of all reporting groups
39618|NCT02169414|B4|Baseline|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 25 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39619|NCT02169414|B3|Baseline|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39620|NCT02169414|B2|Baseline|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39621|NCT02169414|B1|Baseline|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39622|NCT02169414|P4|Participant Flow|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39623|NCT02169414|P3|Participant Flow|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 25 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39624|NCT02169414|P2|Participant Flow|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39625|NCT02169414|P1|Participant Flow|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39626|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39627|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39628|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39629|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39630|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39631|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39632|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39633|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39634|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39635|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39636|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39637|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39664|NCT02169336|B2|Baseline|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.
Intranasal Dexmedetomidine"
40034|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
39638|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39639|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39640|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39641|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
39642|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39643|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
39644|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39645|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39646|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39647|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
39648|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39649|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39650|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39651|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
39652|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39653|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39654|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39655|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
39656|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39657|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
39658|NCT02169414|E4|Reported Event|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 25 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39659|NCT02169414|E3|Reported Event|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39660|NCT02169414|E2|Reported Event|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39661|NCT02169414|E1|Reported Event|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
39662|NCT02169336|B4|Baseline|Total|Total of all reporting groups
39663|NCT02169336|B3|Baseline|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.
Intranasal Placebo"
39665|NCT02169336|B1|Baseline|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.
Intranasal Dexmedetomidine"
39666|NCT02169336|P3|Participant Flow|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.
Intranasal Placebo"
39667|NCT02169336|P2|Participant Flow|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.
Intranasal Dexmedetomidine"
39668|NCT02169336|P1|Participant Flow|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.
Intranasal Dexmedetomidine"
39669|NCT02169336|O3|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.
Intranasal Placebo"
39670|NCT02169336|O2|Outcome|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.
Intranasal Dexmedetomidine"
39671|NCT02169336|O1|Outcome|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.
Intranasal Dexmedetomidine"
39672|NCT02169336|E3|Reported Event|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.
Intranasal Placebo"
39673|NCT02169336|E2|Reported Event|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.
Intranasal Dexmedetomidine"
39674|NCT02169336|E1|Reported Event|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.
Intranasal Dexmedetomidine"
39675|NCT02169115|B4|Baseline|Total|Total of all reporting groups
39676|NCT02169115|B3|Baseline|Placebo|Placebo: Placebo, s.c., every 4 weeks
39677|NCT02169115|B2|Baseline|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
39678|NCT02169115|B1|Baseline|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
39679|NCT02169115|P3|Participant Flow|Placebo|Placebo: Placebo, s.c., every 4 weeks
39680|NCT02169115|P2|Participant Flow|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
39681|NCT02169115|P1|Participant Flow|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
39682|NCT02169115|O3|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
39683|NCT02169115|O2|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
39684|NCT02169115|O1|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
39685|NCT02169115|E3|Reported Event|Placebo|Placebo: Placebo, s.c., every 4 weeks
39686|NCT02169115|E2|Reported Event|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
39687|NCT02169115|E1|Reported Event|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
39688|NCT02168491|B1|Baseline|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
39689|NCT02168491|P1|Participant Flow|Lixisenatide With Basal Insulin (LixiBIT)|"Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
Lixisenatide: Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of premixed insulin will be calculated based on the records of the run in period. The initial dose of insulin glargine will be adjusted at about 60% of the daily insulin dose of premixed insulin. This is based on the observed reduction of required insulin dose described in recent literature upon initiation with a GLP-1 agonist.
Insulin glargine: Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of"
39690|NCT02168491|O1|Outcome|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
39691|NCT02168491|O1|Outcome|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
39692|NCT02168491|O1|Outcome|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
39693|NCT02168491|E1|Reported Event|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
39694|NCT02168478|B1|Baseline|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.
All test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.
Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.
Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.
Saline: Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae."
39695|NCT02168478|P1|Participant Flow|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.
Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.
Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.
Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.
Saline: Saline is applied to the absorbent pad portion of a"
39728|NCT02168387|E2|Reported Event|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
39775|NCT02167139|B1|Baseline|SB5 (Proposed Biosimilar to Adalimumab)|"SB5 40 mg every other week via subcutaneous injection
SB5 (proposed biosimilar to adalimumab)"
39696|NCT02168478|O1|Outcome|Patch Test Group|"Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.
Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 mL of the positive, 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.
Saline: Approximately 0.2 mL of saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours."
39697|NCT02168478|E1|Reported Event|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline. Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.
Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae.
Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae.
Saline: Approximately 0.2 ml of the saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae."
39698|NCT02168439|B3|Baseline|Total|Total of all reporting groups
39699|NCT02168439|B2|Baseline|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram
Midazolam: ."
39700|NCT02168439|B1|Baseline|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once
Dexmedetomidine: ."
39701|NCT02168439|P2|Participant Flow|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram
Midazolam: 20 patients enrolled, 18 underwent analysis"
39702|NCT02168439|P1|Participant Flow|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once
Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
39703|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram
Midazolam: 20 patients enrolled, 18 underwent analysis"
39704|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once
Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
39705|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram
Midazolam: 20 patients enrolled, 18 underwent analysis"
39706|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once
Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
39707|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram
Midazolam: 20 patients enrolled, 18 underwent analysis"
39708|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once
Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
39709|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram
Midazolam: 20 patients enrolled, 18 underwent analysis"
39710|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once
Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
39711|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram
Midazolam: 20 patients enrolled, 18 underwent analysis"
39712|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once
Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
39713|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram
Midazolam: 20 patients enrolled, 18 underwent analysis"
39714|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once
Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
39715|NCT02168439|E2|Reported Event|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram
Midazolam: 20 patients enrolled, 18 underwent analysis"
39716|NCT02168439|E1|Reported Event|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once
Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
39717|NCT02168387|B3|Baseline|Total|Total of all reporting groups
39718|NCT02168387|B2|Baseline|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
39719|NCT02168387|B1|Baseline|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
39720|NCT02168387|P2|Participant Flow|Continuous High Frequency Oscillator (CHFO)|"Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
continuous high frequency oscillator (CHFO)"
39721|NCT02168387|P1|Participant Flow|Medication|"Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
Acetylcysteine
dornase alfa"
39722|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
39723|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
39724|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
39725|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
39726|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
39727|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
39774|NCT02167139|B2|Baseline|Humira (Adalimumab)|"Humira 40 mg every other week via subcutaneous injection
Humira (adalimumab)
SB5 (proposed biosimilar to adalimumab)"
39729|NCT02168387|E1|Reported Event|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
39730|NCT02168361|B3|Baseline|Total|Total of all reporting groups
39731|NCT02168361|B2|Baseline|Interferon-containing Arm|
39732|NCT02168361|B1|Baseline|Oral Therapy Arm|
39733|NCT02168361|P2|Participant Flow|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
39734|NCT02168361|P1|Participant Flow|All Oral Therapy|Simeprevir-sofosbuvir
39735|NCT02168361|O2|Outcome|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
39736|NCT02168361|O1|Outcome|All Oral Therapy|Simeprevir-sofosbuvir
39737|NCT02168361|O2|Outcome|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
39738|NCT02168361|O1|Outcome|All Oral Therapy|Simeprevir-sofosbuvir
39739|NCT02168361|E2|Reported Event|Interferon-containing|
39740|NCT02168361|E1|Reported Event|All Oral|
39741|NCT02167893|B1|Baseline|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
39742|NCT02167893|P1|Participant Flow|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
39743|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
39744|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
39745|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
39746|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
39747|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
39748|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
39749|NCT02167893|E1|Reported Event|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
39750|NCT02167867|B3|Baseline|Total|Total of all reporting groups
39751|NCT02167867|B2|Baseline|Treatment Subject Group|Treatment subjects received 6 40-minute evenly spaced treatments to the hips, waist and thighs (20 minutes to the front side and 20 minutes to the back side) with the ZERONA Z6 over 2 consecutive weeks. The ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes.
39752|NCT02167867|B1|Baseline|Lay End Users|Employees of the test sites (that were fitness centers or spas) who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of one Treatment Subject.
39753|NCT02167867|P2|Participant Flow|Treatment Subject Group|Subjects who received active treatments with the study device administered by the Lay End Users.
39754|NCT02167867|P1|Participant Flow|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of a Treatment Subject.
39755|NCT02167867|O1|Outcome|Treatment Subject Group|Individuals who got the active treatments with the ZERONA Z6.
39756|NCT02167867|O1|Outcome|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist. hips and thighs.
39757|NCT02167867|O1|Outcome|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist. hips and thighs.
39758|NCT02167867|E1|Reported Event|ZERONA Z6|"ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes. 6 40-minute evenly spaced treatments are administered over 2 consecutive weeks.
ZERONA Z6: 20 minutes of treatment to the front side of the waist, hips and thighs and 20 minutes of treatment to the back side of the waist, hips and thighs."
39759|NCT02167815|B3|Baseline|Total|Total of all reporting groups
39760|NCT02167815|B2|Baseline|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
39761|NCT02167815|B1|Baseline|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)
standard care"
39762|NCT02167815|P2|Participant Flow|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
39763|NCT02167815|P1|Participant Flow|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)
standard care"
39764|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
39765|NCT02167815|O2|Outcome|Standard Care|observation group, treated according to investigation sites, standard care
39766|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
39767|NCT02167815|O2|Outcome|Standard Care|observation group, treated according to investigation sites standard care
39768|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
39769|NCT02167815|O2|Outcome|Standard Care|observation group, treating according to investigation sites standard care
39770|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
39771|NCT02167815|E2|Reported Event|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
39772|NCT02167815|E1|Reported Event|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)
standard care"
39773|NCT02167139|B3|Baseline|Total|Total of all reporting groups
63623|NCT01991314|E2|Reported Event|Adults|IBD patients aged >18
39776|NCT02167139|P4|Participant Flow|Humira (Adalimumab), Continue as Humira|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
39777|NCT02167139|P3|Participant Flow|Humira (Adalimumab), Switch to SB5|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
39778|NCT02167139|P2|Participant Flow|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
39779|NCT02167139|P1|Participant Flow|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
39780|NCT02167139|O5|Outcome|Humira (Adalimumab), Continue as Humira at Week 52|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
39781|NCT02167139|O4|Outcome|Humira (Adalimumab), Switch to SB5 at Week 52|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
39782|NCT02167139|O3|Outcome|SB5 (Proposed Biosimilar to Adalimumab) at Week 52|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
39783|NCT02167139|O2|Outcome|Humira (Adalimumab) at Week 24|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
39784|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab) at Week 24|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
39785|NCT02167139|O3|Outcome|Humira (Adalimumab), Continue as Humira|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
39786|NCT02167139|O2|Outcome|Humira (Adalimumab), Switch to SB5|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
39787|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
39788|NCT02167139|O2|Outcome|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection up to Week 24
39789|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection up to Week 24
39790|NCT02167139|E2|Reported Event|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
39791|NCT02167139|E1|Reported Event|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
39792|NCT02166697|B1|Baseline|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
39793|NCT02166697|P1|Participant Flow|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
39794|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
39795|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
39796|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
39797|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
39798|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
39799|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
39800|NCT02166697|E1|Reported Event|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
39801|NCT02165826|B4|Baseline|Total|Total of all reporting groups
39802|NCT02165826|B3|Baseline|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
39803|NCT02165826|B2|Baseline|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39804|NCT02165826|B1|Baseline|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39805|NCT02165826|P3|Participant Flow|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
39806|NCT02165826|P2|Participant Flow|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39807|NCT02165826|P1|Participant Flow|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39808|NCT02165826|O2|Outcome|Roflumilast 500 μg OD_CFB in FEV1 @ Week 12|Roflumilast 500 μg, tablets, orally, once daily (OD) for 12 weeks. Results for Change from Baseline in FEV1 at Week 12.
39809|NCT02165826|O1|Outcome|Roflumilast 500 μg OD_CFB in FEV1 @ Week 4|Roflumilast 500 μg, tablets, orally, once daily (OD) for 12 weeks. Results for Change from Baseline in FEV1 at Week 4.
39810|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
39811|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD|Roflumilast 500 μg, orally, every other day (EOD) at least 1 dose in the Main Period
39812|NCT02165826|O1|Outcome|Roflumilast 250 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
39813|NCT02165826|O2|Outcome|Roflumilast 250 μg OD|Roflumilast 500 μg at least one dose in the Main Period followed by Roflumilast 250 μg tablets, orally, once daily in the Down -Titration Period.
39814|NCT02165826|O1|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
39815|NCT02165826|O4|Outcome|Roflumilast 250 µg Down-Titration|250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39816|NCT02165826|O3|Outcome|Roflumilast 250 μg OD|Roflumilast 250 μg tablets, orally, once daily in the Main Period.
39817|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD|Roflumilast 500 μg, tablets, orally, every other day (EOD) in the Main Period.
39818|NCT02165826|O1|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
39819|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
39820|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
39821|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
39822|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
39823|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
39824|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
39825|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
39826|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
39827|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39828|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39829|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39830|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
39831|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39832|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39833|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39834|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39835|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39836|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
39837|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39838|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39839|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
39840|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
63625|NCT01990898|B1|Baseline|Treatment|Cyclosporine
39841|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39842|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39843|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39844|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39845|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39846|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39847|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39848|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39849|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39850|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39851|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
39852|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39853|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39854|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
39855|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39856|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39857|NCT02165826|E6|Reported Event|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39858|NCT02165826|E5|Reported Event|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39859|NCT02165826|E4|Reported Event|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39860|NCT02165826|E3|Reported Event|Roflumilast 500 μg OD_Main Treatment Period|Roflumilast 500 μg tablets, orally, once daily for 12 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39933|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39861|NCT02165826|E2|Reported Event|Roflumilast 500 μg EOD Then 500 μg OD_Main Treatment Period|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39862|NCT02165826|E1|Reported Event|Roflumilast 250 μg OD Then 500 μg OD_Main Treatment Period|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
39863|NCT02165462|B1|Baseline|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39864|NCT02165462|P1|Participant Flow|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39865|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39866|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39867|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39868|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39869|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39870|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39871|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39872|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39873|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39874|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39875|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39876|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39877|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39878|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39879|NCT02165462|E1|Reported Event|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
39880|NCT02165111|B3|Baseline|Total|Total of all reporting groups
39881|NCT02165111|B2|Baseline|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).
sterile saline solution"
40031|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
39882|NCT02165111|B1|Baseline|Onabotulinumtoxin A|"One hand of each patient was be randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.
Onabotulinumtoxin A"
39883|NCT02165111|P2|Participant Flow|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each)."
39884|NCT02165111|P1|Participant Flow|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand."
39885|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).
sterile saline solution"
39886|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.
Onabotulinumtoxin A"
39887|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).
sterile saline solution"
39888|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.
Onabotulinumtoxin A"
39889|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).
sterile saline solution"
39890|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.
Onabotulinumtoxin A"
39891|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).
sterile saline solution"
39892|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.
Onabotulinumtoxin A"
39893|NCT02165111|O2|Outcome|Placebo|"One hand of each patient were randomly selected for injection of sterile saline solution (placebo).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).
sterile saline solution"
39912|NCT02164539|P6|Participant Flow|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
40032|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
39894|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient were randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.
Onabotulinumtoxin A"
39895|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).
sterile saline solution"
39896|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.
Onabotulinumtoxin A"
39897|NCT02165111|E2|Reported Event|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).
sterile saline solution"
39898|NCT02165111|E1|Reported Event|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).
Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.
Onabotulinumtoxin A"
39899|NCT02165072|B1|Baseline|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
39900|NCT02165072|P1|Participant Flow|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
39901|NCT02165072|O1|Outcome|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
39902|NCT02165072|O1|Outcome|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
39903|NCT02165072|E1|Reported Event|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
39904|NCT02164539|B7|Baseline|Total|Total of all reporting groups
39905|NCT02164539|B6|Baseline|FF/VI 100/25 µg|Participants received FF 100 µg in combination with VI 25 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39906|NCT02164539|B5|Baseline|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39907|NCT02164539|B4|Baseline|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39908|NCT02164539|B3|Baseline|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39909|NCT02164539|B2|Baseline|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with UMEC 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39910|NCT02164539|B1|Baseline|FF 100 µg|Participants received FF 100 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39911|NCT02164539|P7|Participant Flow|FF/UMEC/VI 100/250/25 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 &amp;amp; VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39979|NCT02164318|P4|Participant Flow|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Handgrip training
Nitroglycerin ointment"
39913|NCT02164539|P5|Participant Flow|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39914|NCT02164539|P4|Participant Flow|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39915|NCT02164539|P3|Participant Flow|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39916|NCT02164539|P2|Participant Flow|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39917|NCT02164539|P1|Participant Flow|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
39918|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39919|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39920|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39921|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39922|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39923|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
39924|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39925|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39926|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39927|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39928|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39929|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
39930|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39931|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39932|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39980|NCT02164318|P3|Participant Flow|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Nitroglycerin ointment"
39934|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39935|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
39936|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39937|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39938|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39939|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39940|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39941|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
39942|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39943|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39944|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39945|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39946|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39947|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
39948|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39949|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39950|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39951|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39952|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39953|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
39981|NCT02164318|P2|Participant Flow|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes
Handgrip training"
39982|NCT02164318|P1|Participant Flow|Control Group|Standard of care
40033|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
39954|NCT02164539|E7|Reported Event|FF/UMEC/VI 100/250/25 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 &amp;amp; VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39955|NCT02164539|E6|Reported Event|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39956|NCT02164539|E5|Reported Event|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39957|NCT02164539|E4|Reported Event|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39958|NCT02164539|E3|Reported Event|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39959|NCT02164539|E2|Reported Event|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
39960|NCT02164539|E1|Reported Event|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
39961|NCT02164396|B4|Baseline|Total|Total of all reporting groups
39962|NCT02164396|B3|Baseline|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
39963|NCT02164396|B2|Baseline|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
39964|NCT02164396|B1|Baseline|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
39965|NCT02164396|P3|Participant Flow|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
39966|NCT02164396|P2|Participant Flow|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
39967|NCT02164396|P1|Participant Flow|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
39968|NCT02164396|O3|Outcome|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
39969|NCT02164396|O2|Outcome|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
39970|NCT02164396|O1|Outcome|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
39971|NCT02164396|E3|Reported Event|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
39972|NCT02164396|E2|Reported Event|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
39973|NCT02164396|E1|Reported Event|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
39974|NCT02164318|B5|Baseline|Total|Total of all reporting groups
39975|NCT02164318|B4|Baseline|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Handgrip training
Nitroglycerin ointment"
39976|NCT02164318|B3|Baseline|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Nitroglycerin ointment"
39977|NCT02164318|B2|Baseline|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes
Handgrip training"
39978|NCT02164318|B1|Baseline|Control Group|Standard of care
40029|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40030|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
39983|NCT02164318|O4|Outcome|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Handgrip training
Nitroglycerin ointment"
39984|NCT02164318|O3|Outcome|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Nitroglycerin ointment"
39985|NCT02164318|O2|Outcome|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes
Handgrip training"
39986|NCT02164318|O1|Outcome|Control Group|Standard of care
39987|NCT02164318|O4|Outcome|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Handgrip training
Nitroglycerin ointment"
39988|NCT02164318|O3|Outcome|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Nitroglycerin ointment"
39989|NCT02164318|O2|Outcome|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes
Handgrip training"
39990|NCT02164318|O1|Outcome|Control Group|Standard of care
39991|NCT02164318|O4|Outcome|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Handgrip training
Nitroglycerin ointment"
39992|NCT02164318|O3|Outcome|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Nitroglycerin ointment"
39993|NCT02164318|O2|Outcome|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes
Handgrip training"
39994|NCT02164318|O1|Outcome|Control Group|Standard of care
39995|NCT02164318|E4|Reported Event|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Handgrip training
Nitroglycerin ointment"
39996|NCT02164318|E3|Reported Event|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Nitroglycerin ointment"
39997|NCT02164318|E2|Reported Event|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes
Handgrip training"
39998|NCT02164318|E1|Reported Event|Control Group|Standard of care
39999|NCT02163915|B6|Baseline|Total|Total of all reporting groups
40000|NCT02163915|B5|Baseline|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40001|NCT02163915|B4|Baseline|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40002|NCT02163915|B3|Baseline|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40003|NCT02163915|B2|Baseline|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
40004|NCT02163915|B1|Baseline|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
40005|NCT02163915|P5|Participant Flow|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40006|NCT02163915|P4|Participant Flow|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40007|NCT02163915|P3|Participant Flow|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40008|NCT02163915|P2|Participant Flow|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
40009|NCT02163915|P1|Participant Flow|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
40010|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40011|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40012|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40013|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
40014|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
40015|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40016|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40017|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40018|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
40019|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40020|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40021|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40022|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
40023|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40024|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40025|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40026|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
40027|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40028|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40083|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40035|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
40036|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40037|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40038|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40039|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
40040|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
40041|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40042|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40043|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40044|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
40045|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
40046|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40047|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40048|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40049|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
40050|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
40051|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40052|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40053|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40054|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
40055|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
40056|NCT02163915|E5|Reported Event|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
40057|NCT02163915|E4|Reported Event|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
40058|NCT02163915|E3|Reported Event|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
40059|NCT02163915|E2|Reported Event|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
40060|NCT02163915|E1|Reported Event|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
40061|NCT02163733|B3|Baseline|Total|Total of all reporting groups
40062|NCT02163733|B2|Baseline|Fasted/Fed|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fasted/Fed treatment group followed Sequence 2: AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
40063|NCT02163733|B1|Baseline|Fed/Fasted|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fed/Fasted treatment group followed Sequence 1: AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
40064|NCT02163733|P3|Participant Flow|AZD9291 Alone (Part B)|In Part B of the study, each patient (who completed Part A) received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
40065|NCT02163733|P2|Participant Flow|Fasted/Fed|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fasted/Fed treatment group followed Sequence 2: AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
40066|NCT02163733|P1|Participant Flow|Fed/Fasted|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fed/Fasted treatment group followed Sequence 1: AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
40067|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40068|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40069|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40070|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40071|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40072|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40073|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40074|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40075|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40076|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40077|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40078|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40079|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40080|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40081|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40082|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40085|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
72923|NCT01940146|B1|Baseline|SPARC Placebo|Baseline characteristics: Age
40088|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40089|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40090|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40091|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40092|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40093|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40094|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40095|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
40096|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
40097|NCT02163733|E3|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
40098|NCT02163733|E2|Reported Event|Part A Safety Population|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients were randomised to either Sequence 1 (AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2) or Sequence 2 (AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2).
40099|NCT02163733|E1|Reported Event|Overall Safety Population|Parts A and B of the study combined.
40100|NCT02163421|B5|Baseline|Total|Total of all reporting groups
40101|NCT02163421|B4|Baseline|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
40102|NCT02163421|B3|Baseline|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
40103|NCT02163421|B2|Baseline|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
40104|NCT02163421|B1|Baseline|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
40105|NCT02163421|P4|Participant Flow|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
40106|NCT02163421|P3|Participant Flow|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
40107|NCT02163421|P2|Participant Flow|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
40108|NCT02163421|P1|Participant Flow|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
40109|NCT02163421|O1|Outcome|Vedolizumab Subcutaneous|Vedolizumab 54 mg or 108 mg or 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
40110|NCT02163421|E4|Reported Event|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
40111|NCT02163421|E3|Reported Event|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
40112|NCT02163421|E2|Reported Event|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
40113|NCT02163421|E1|Reported Event|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
40114|NCT02163395|B1|Baseline|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm
FullCeram implant: FullCeram implantation"
40115|NCT02163395|P1|Participant Flow|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm
FullCeram implant: FullCeram implantation"
40116|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm
FullCeram implant: FullCeram implantation"
40117|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm
FullCeram implant: FullCeram implantation"
40118|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm
FullCeram implant: FullCeram implantation"
40119|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm
FullCeram implant: FullCeram implantation"
40120|NCT02163395|E1|Reported Event|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm
FullCeram implant: FullCeram implantation"
40121|NCT02162979|B3|Baseline|Total|Total of all reporting groups
40122|NCT02162979|B2|Baseline|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
Placebo"
40123|NCT02162979|B1|Baseline|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
sildenafil: sildenafil 50mg BID for 2 weeks"
40124|NCT02162979|P2|Participant Flow|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
Placebo"
40125|NCT02162979|P1|Participant Flow|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
sildenafil: sildenafil 50mg BID for 2 weeks"
40170|NCT02161146|B3|Baseline|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
40126|NCT02162979|O2|Outcome|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
Placebo"
40436|NCT02158273|P1|Participant Flow|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
40127|NCT02162979|O1|Outcome|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
sildenafil: sildenafil 50mg BID for 2 weeks"
40128|NCT02162979|E2|Reported Event|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
Placebo"
40129|NCT02162979|E1|Reported Event|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
sildenafil: sildenafil 50mg BID for 2 weeks"
40130|NCT02162758|B3|Baseline|Total|Total of all reporting groups
40131|NCT02162758|B2|Baseline|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
40132|NCT02162758|B1|Baseline|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
40133|NCT02162758|P2|Participant Flow|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
40134|NCT02162758|P1|Participant Flow|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
40135|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
40136|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
40137|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
40138|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
40139|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
40140|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
40141|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
40142|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
40143|NCT02162758|E2|Reported Event|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
40144|NCT02162758|E1|Reported Event|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
40145|NCT02162680|B4|Baseline|Total|Total of all reporting groups
40146|NCT02162680|B3|Baseline|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection
bacteriostatic normal saline (BNS)"
40147|NCT02162680|B2|Baseline|Lidocaine|"1% lidocaine intradermal injection
1% lidocaine"
40148|NCT02162680|B1|Baseline|no Local Anesthetic|usual care practice of no local anesthetic administration
40149|NCT02162680|P3|Participant Flow|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection
bacteriostatic normal saline (BNS)"
40150|NCT02162680|P2|Participant Flow|Lidocaine|"1% lidocaine intradermal injection
1% lidocaine"
40151|NCT02162680|P1|Participant Flow|no Local Anesthetic|usual care practice of no local anesthetic administration
40152|NCT02162680|O3|Outcome|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection
bacteriostatic normal saline (BNS)"
40153|NCT02162680|O2|Outcome|Lidocaine|"1% lidocaine intradermal injection
1% lidocaine"
40154|NCT02162680|O1|Outcome|no Local Anesthetic|usual care practice of no local anesthetic administration
40155|NCT02162680|E3|Reported Event|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection
bacteriostatic normal saline (BNS)"
40156|NCT02162680|E2|Reported Event|Lidocaine|"1% lidocaine intradermal injection
1% lidocaine"
40157|NCT02162680|E1|Reported Event|no Local Anesthetic|usual care practice of no local anesthetic administration
40158|NCT02161549|B3|Baseline|Total|Total of all reporting groups
40159|NCT02161549|B2|Baseline|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0
Motus Gl CleanUp System"
40160|NCT02161549|B1|Baseline|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0
Motus Gl CleanUp System"
40161|NCT02161549|P2|Participant Flow|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0
Motus Gl CleanUp System"
40162|NCT02161549|P1|Participant Flow|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0
Motus Gl CleanUp System"
40163|NCT02161549|O2|Outcome|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0
Motus Gl CleanUp System"
40164|NCT02161549|O1|Outcome|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0
Motus Gl CleanUp System"
40165|NCT02161549|E2|Reported Event|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0
Motus Gl CleanUp System"
40166|NCT02161549|E1|Reported Event|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0
Motus Gl CleanUp System"
40167|NCT02161146|B6|Baseline|Total|Total of all reporting groups
40168|NCT02161146|B5|Baseline|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
40169|NCT02161146|B4|Baseline|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
40171|NCT02161146|B2|Baseline|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
40172|NCT02161146|B1|Baseline|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
40173|NCT02161146|P5|Participant Flow|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
40174|NCT02161146|P4|Participant Flow|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
40175|NCT02161146|P3|Participant Flow|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
40176|NCT02161146|P2|Participant Flow|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
40177|NCT02161146|P1|Participant Flow|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
40178|NCT02161146|O3|Outcome|Olopatadine|One drop of olopatadine in the eye on Days 1 and 15.
40179|NCT02161146|O2|Outcome|Vehicle|One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
40180|NCT02161146|O1|Outcome|AGN-229666|One drop of AGN-229666 in the eye on Days 1 and 15.
40181|NCT02161146|O3|Outcome|Olopatadine|One drop of olopatadine in the eye on Days 1 and 15.
40182|NCT02161146|O2|Outcome|Vehicle|One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
40183|NCT02161146|O1|Outcome|AGN-229666|One drop of AGN-229666 in the eye on Days 1 and 15.
40184|NCT02161146|E5|Reported Event|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
40185|NCT02161146|E4|Reported Event|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
40186|NCT02161146|E3|Reported Event|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
40187|NCT02161146|E2|Reported Event|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
40188|NCT02161146|E1|Reported Event|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
40189|NCT02161016|B1|Baseline|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
40190|NCT02161016|P1|Participant Flow|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
40191|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
40192|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
40193|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
40194|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
40195|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
40196|NCT02161016|E1|Reported Event|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
40197|NCT02160990|B3|Baseline|Total|Total of all reporting groups
40198|NCT02160990|B2|Baseline|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
40199|NCT02160990|B1|Baseline|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
40200|NCT02160990|P2|Participant Flow|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
40201|NCT02160990|P1|Participant Flow|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
40202|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
40203|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
40204|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
40205|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
40206|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
40207|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
40208|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
40209|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
40210|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
40211|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
40212|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
40213|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
40214|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
40215|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
40309|NCT02159547|B2|Baseline|Normal Slaline|"50 ml normal saline
Normal Saline: 50 ml normal saline"
40216|NCT02160990|E2|Reported Event|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
40437|NCT02158273|O2|Outcome|Placebo|Matched Placebo
40217|NCT02160990|E1|Reported Event|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
40218|NCT02160977|B3|Baseline|Total|Total of all reporting groups
40219|NCT02160977|B2|Baseline|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty"
40220|NCT02160977|B1|Baseline|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty"
40221|NCT02160977|P2|Participant Flow|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty"
40222|NCT02160977|P1|Participant Flow|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty"
40223|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty"
40224|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty"
40225|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty"
40226|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty"
40227|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty"
40228|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty"
40229|NCT02160977|E2|Reported Event|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
total knee arthroplasty"
40230|NCT02160977|E1|Reported Event|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
total knee arthroplasty"
40231|NCT02160873|B3|Baseline|Total|Total of all reporting groups
40232|NCT02160873|B2|Baseline|Flavor-matched Placebo, Then Chocolate Milk|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before) followed by a 7-day washout, then chocolate milk 7-8 hours prior to exercise trial.
40233|NCT02160873|B1|Baseline|Chocolate Milk First, Then Placebo|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before) followed by a 7-day washout, then placebo 7-8 hours prior to exercise trial.
40234|NCT02160873|P2|Participant Flow|Flavor-matched Placebo, Then Chocolate Milk.|Subjects received flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received 12 oz of chocolate milk 7-8 hours prior to exercise.
40235|NCT02160873|P1|Participant Flow|Chocolate Milk, Then Placebo|Subjects received chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received the placebo beverage 7-8 hours prior to the exercise trial.
40236|NCT02160873|O2|Outcome|Flavor-matched Placebo|Subjects received flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received 12 oz of chocolate milk 7-8 hours prior to exercise.
40237|NCT02160873|O1|Outcome|Chocolate Milk|Subjects received chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received the placebo beverage 7-8 hours prior to the exercise trial.
40238|NCT02160873|O2|Outcome|Flavor-matched Placebo|"In this arm, subjects receive a flavor-matched placebo
flavor-matched placebo: 12 oz, non-caloric flavor-matched placebo"
40239|NCT02160873|O1|Outcome|Chocolate Milk|"In this arm, subjects receive chocolate milk
chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)"
40240|NCT02160873|O2|Outcome|Flavor-matched Placebo|"In this arm, subjects receive a flavor-matched placebo (in a cross-over design)
flavor-matched placebo: 12 oz, non-caloric flavor-matched placebo"
40241|NCT02160873|O1|Outcome|Chocolate Milk|"In this arm, subjects receive chocolate milk (in a cross-over design)
chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)"
40242|NCT02160873|O2|Outcome|Flavor-matched Placebo|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
40243|NCT02160873|O1|Outcome|Chocolate Milk|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)
40244|NCT02160873|E2|Reported Event|Flavor-matched Placebo|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
40245|NCT02160873|E1|Reported Event|Chocolate Milk|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)
40246|NCT02160314|B3|Baseline|Total|Total of all reporting groups
40247|NCT02160314|B2|Baseline|Pessary|"disposable, single-use pessary
pessary: disposable, single-use pessary"
40248|NCT02160314|B1|Baseline|Pad Control|"absorbent pad control
Absorbent pad"
40249|NCT02160314|P2|Participant Flow|Pessary|pessary: disposable, single-use
40250|NCT02160314|P1|Participant Flow|Pad Control|absorbent pad control
40251|NCT02160314|O2|Outcome|Pessary|"disposable, single-use pessary
pessary: disposable, single-use pessary"
40252|NCT02160314|O1|Outcome|Pad Control|"absorbent pad control
Absorbent pad"
40253|NCT02160314|E2|Reported Event|Pessary|disposable, single-use pessary
40254|NCT02160314|E1|Reported Event|Pad Control|absorbent pad control
40255|NCT02159950|B3|Baseline|Total|Total of all reporting groups
40256|NCT02159950|B2|Baseline|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40257|NCT02159950|B1|Baseline|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40306|NCT02159768|O1|Outcome|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone
Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
40438|NCT02158273|O1|Outcome|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
40258|NCT02159950|P2|Participant Flow|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40259|NCT02159950|P1|Participant Flow|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40260|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40261|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40262|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40263|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40264|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40265|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40266|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40267|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40268|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40269|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40270|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40271|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40272|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40273|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40274|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40275|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40276|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40307|NCT02159768|E1|Reported Event|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone
Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
40277|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40278|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40279|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40280|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40281|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40282|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40283|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40284|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40285|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40286|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40287|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40288|NCT02159950|E2|Reported Event|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV
Tasquinimod: Given PO"
40289|NCT02159950|E1|Reported Event|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Sipuleucel-T: Given IV"
40290|NCT02159859|B1|Baseline|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40291|NCT02159859|P1|Participant Flow|Ertapenem|"Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session
Ertapenem: Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn"
40292|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40293|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40294|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40295|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40296|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40297|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40298|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40299|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40300|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40301|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40302|NCT02159859|E1|Reported Event|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
40303|NCT02159768|B1|Baseline|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone
Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
40304|NCT02159768|P1|Participant Flow|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone
Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
40305|NCT02159768|O1|Outcome|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone
Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
40310|NCT02159547|B1|Baseline|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
40311|NCT02159547|P2|Participant Flow|Normal Slaline|"50 ml normal saline
Normal Saline: 50 ml normal saline"
40312|NCT02159547|P1|Participant Flow|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
40313|NCT02159547|O2|Outcome|Normal Slaline|"50 ml normal saline
Normal Saline: 50 ml normal saline"
40314|NCT02159547|O1|Outcome|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
40315|NCT02159547|O2|Outcome|Normal Slaline|"50 ml normal saline
Normal Saline: 50 ml normal saline"
40316|NCT02159547|O1|Outcome|Dexketoprofen|50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
40317|NCT02159547|E2|Reported Event|Normal Slaline|"50 ml normal saline
Normal Saline: 50 ml normal saline"
40318|NCT02159547|E1|Reported Event|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
40319|NCT02159482|B1|Baseline|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.
Interferon Alfa-2a"
40320|NCT02159482|P1|Participant Flow|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.
Interferon Alfa-2a"
40321|NCT02159482|O1|Outcome|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.
Interferon Alfa-2a"
40322|NCT02159482|O1|Outcome|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.
Interferon Alfa-2a"
40323|NCT02159482|E1|Reported Event|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.
Interferon Alfa-2a"
40324|NCT02159365|B1|Baseline|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.
During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.
A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
40325|NCT02159365|P1|Participant Flow|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.
During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.
A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
40326|NCT02159365|O1|Outcome|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.
During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.
A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
40327|NCT02159365|E1|Reported Event|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.
During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.
A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
40328|NCT02159352|B3|Baseline|Total|Total of all reporting groups
40329|NCT02159352|B2|Baseline|Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
40330|NCT02159352|B1|Baseline|Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40331|NCT02159352|P2|Participant Flow|Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
40434|NCT02158273|B1|Baseline|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
40332|NCT02159352|P1|Participant Flow|Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40333|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
40334|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40335|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40336|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40337|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
40338|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40339|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40340|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40341|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
40342|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40343|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and 100-mg ritonavir capsule once daily on Days 5 through 14.
40344|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40345|NCT02159352|O2|Outcome|Group 2: Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
40346|NCT02159352|O1|Outcome|Group 1: Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40347|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 -mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
40348|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40349|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40350|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40351|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
40352|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40353|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40354|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40355|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
40356|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received 60 mg of daclatasvir tablet once daily from Day 1 through 4.
40357|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40358|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40359|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
40360|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received 60 mg of daclatasvir tablet once daily from Day 1 through 4.
40361|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40362|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40363|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
40364|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40365|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40366|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40435|NCT02158273|P2|Participant Flow|Placebo|Matched Placebo
40367|NCT02159352|O4|Outcome|Daclatasvir (30 mg) + Lopinavir/Ritonavir Days 5-14|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily Days 5 through 14.
40368|NCT02159352|O3|Outcome|Daclatasvir (60 mg) Days 5-14|Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14.
40369|NCT02159352|O2|Outcome|Daclatasvir (30 mg) + Darunavir/Ritonavir Days 5-14|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40370|NCT02159352|O1|Outcome|Daclatasvir (60 mg) Days 1-4|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40371|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily Days 5 through 14.
40372|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14.
40373|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet, and a 100-mg ritonavir capsule once daily on Days 5 through 14.
40374|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40375|NCT02159352|E6|Reported Event|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
40376|NCT02159352|E5|Reported Event|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40377|NCT02159352|E4|Reported Event|Group 2: Total|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100­-mg ritonavir capsule once daily on Days 5 through 14.
40378|NCT02159352|E3|Reported Event|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg of ritonavir capsule once daily on Days 5 through 14.
40379|NCT02159352|E2|Reported Event|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
40380|NCT02159352|E1|Reported Event|Group 1: Total|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and 30 mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg of ritonavir capsule once daily on Days 5 through 14.
40381|NCT02159118|B3|Baseline|Total|Total of all reporting groups
40382|NCT02159118|B2|Baseline|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40383|NCT02159118|B1|Baseline|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40384|NCT02159118|P2|Participant Flow|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40385|NCT02159118|P1|Participant Flow|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40386|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40387|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40388|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40389|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40390|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40391|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40392|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40393|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40394|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40431|NCT02158442|E1|Reported Event|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
40432|NCT02158273|B3|Baseline|Total|Total of all reporting groups
40395|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40396|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40397|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40398|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40399|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40400|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40401|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40402|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40403|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40404|NCT02159118|E2|Reported Event|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device
Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40405|NCT02159118|E1|Reported Event|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device
Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
40406|NCT02159040|B1|Baseline|Azacitidine|75mg/m2 7days/28 day cycle
40407|NCT02159040|P1|Participant Flow|Azacitidine|75mg/m2 7days/28 day cycle
40408|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
40409|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
40410|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
40411|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
40412|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
40413|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
40414|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
40415|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
40416|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
40417|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
40418|NCT02159040|E1|Reported Event|Azacitidine|75mg/m2 7days/28 day cycle
40419|NCT02158728|B1|Baseline|ICD Indicated Subjects|Subjects indicated for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or electrophysiology (EP) study (including Non-Invasive ElectroPhysiology Study [NIPS]).
40420|NCT02158728|P1|Participant Flow|ICD Indicated Subjects|"Subjects indicated for ICD/CRT-D implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or electrophysiology (EP) study (including Non-invasive EP study [NIPS])
ICD: implantable cardioverter defibrillator CRT-D: cardiac resynchronization therapy defibrillator"
40421|NCT02158728|O1|Outcome|ICD Indicated Subjects|From the initially 80 enrolled subjects indicated for ICD/CRT-D implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or EP study (including Non-invasive EP Study [NIPS]), 53 subjects provided SVT episode data which qualified for developing and testing new sensing and detection algorithms for a new MedtronicICD. SVT episodes with a ventricular response rate of ≥170 BPM are required in the development of the algorithms.
40422|NCT02158728|E1|Reported Event|ICD Indicated Subjects|Only ICD-indicated subjects undergoing standard ICD/CRT-D implant, ICD/CRT-D change-out, ablation, electrophysiology (EP) study or Non Invasive Programmed Stimulation (NIPS), and who provided a dataset which qualified for developing and testing the sensing and detection algorithms of the new ICD, are included in the analyses.
40423|NCT02158442|B3|Baseline|Total|Total of all reporting groups
40424|NCT02158442|B2|Baseline|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
40425|NCT02158442|B1|Baseline|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
40426|NCT02158442|P2|Participant Flow|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
40427|NCT02158442|P1|Participant Flow|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
40428|NCT02158442|O2|Outcome|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
40429|NCT02158442|O1|Outcome|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
40430|NCT02158442|E2|Reported Event|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
40440|NCT02158273|O1|Outcome|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
40441|NCT02158273|E2|Reported Event|Placebo|Matched Placebo
40442|NCT02158273|E1|Reported Event|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
40443|NCT02158247|B3|Baseline|Total|Total of all reporting groups
40444|NCT02158247|B2|Baseline|Touch and Read Group(Female)|female
40445|NCT02158247|B1|Baseline|Touch and Read Group(Male)|"This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.
Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
40446|NCT02158247|P1|Participant Flow|Tough and Read Group|"This is a virtual experiment based on the anthropometry of the airway length. Conventional group : We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.
Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
40447|NCT02158247|O1|Outcome|Female Airway Length vs Height|"Relationship between airway length and their height are analyzed with linear regression.
Airway length is defined the distance from mouth angle to carina. Additionally it is divided into three parts, from mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina."
40448|NCT02158247|O1|Outcome|Airway Length vs Height in Male|"Relationship between airway length and their height are analyzed with linear regression.
Airway length is defined the distance from mouth angle to carina. Additionally it is divided into three parts, from mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina."
40449|NCT02158247|O2|Outcome|Touch and Read for Normal Group of Female|
40450|NCT02158247|O1|Outcome|Conventional Method for Normal Group of Female|
40451|NCT02158247|O2|Outcome|Touch and Read for Risk Group of Female|
40452|NCT02158247|O1|Outcome|Conventional Method for Risk Group of Female|
40453|NCT02158247|O2|Outcome|Touch and Read for Normal Group of Male|
40454|NCT02158247|O1|Outcome|Conventional Method for Normal Group of Male|
40455|NCT02158247|O2|Outcome|Touch and Read for Risk Group of Male|
40456|NCT02158247|O1|Outcome|Conventional Method for Risk Group of Male|
40457|NCT02158247|O2|Outcome|Airway Length of Female|
40458|NCT02158247|O1|Outcome|Airway Length for Male|
40459|NCT02158247|E2|Reported Event|Touch and Read Group(Female)|female
40460|NCT02158247|E1|Reported Event|Touch and Read Group(Male)|"This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.
Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
40461|NCT02158039|B1|Baseline|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
40462|NCT02158039|P1|Participant Flow|Pancreatic Cyst Ethanol Injection|Endoscopic ultrasound (EUS)-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
40463|NCT02158039|O1|Outcome|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
40464|NCT02158039|O1|Outcome|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
40509|NCT02157883|P1|Participant Flow|AZD9291 and Itraconozole (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole. Each patient received single 80 mg oral doses of AZD9291 tablets on Days 1 and 10, and in addition received itraconazole capsules 200 mg twice daily on Days 6 to 18.
In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
40510|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40511|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40550|NCT02157376|P1|Participant Flow|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
40465|NCT02158039|E1|Reported Event|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
40466|NCT02157948|B3|Baseline|Total|Total of all reporting groups
40467|NCT02157948|B2|Baseline|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
40468|NCT02157948|B1|Baseline|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
40469|NCT02157948|P2|Participant Flow|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
40470|NCT02157948|P1|Participant Flow|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
40471|NCT02157948|O2|Outcome|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
40472|NCT02157948|O1|Outcome|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
40473|NCT02157948|O2|Outcome|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
40474|NCT02157948|O1|Outcome|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
40475|NCT02157948|O2|Outcome|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
40476|NCT02157948|O1|Outcome|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
40477|NCT02157948|E2|Reported Event|Denosumab CP4|Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
40478|NCT02157948|E1|Reported Event|Denosumab CP2|Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
40479|NCT02157935|B3|Baseline|Total|Total of all reporting groups
40480|NCT02157935|B2|Baseline|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
40481|NCT02157935|B1|Baseline|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
40482|NCT02157935|P2|Participant Flow|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
40483|NCT02157935|P1|Participant Flow|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
40484|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
40485|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
40486|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
40487|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
40488|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
40489|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
40490|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
40491|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
40492|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
40493|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
40494|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
40495|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
40496|NCT02157935|E2|Reported Event|Symbicort 160/4.5 ug x2 Bid|
40497|NCT02157935|E1|Reported Event|Formoterol 4.5 ug x2 Bid|
40498|NCT02157909|B3|Baseline|Total|Total of all reporting groups
40499|NCT02157909|B2|Baseline|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
40500|NCT02157909|B1|Baseline|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
40501|NCT02157909|P2|Participant Flow|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
40502|NCT02157909|P1|Participant Flow|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
40503|NCT02157909|O2|Outcome|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
40504|NCT02157909|O1|Outcome|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
40505|NCT02157909|E3|Reported Event|AOA Sphere|Includes all subjects / eyes exposed to AOA Sphere lenses
40506|NCT02157909|E2|Reported Event|AOA Modified|Includes all subjects / eyes exposed to AOA Modified lenses
40507|NCT02157909|E1|Reported Event|Pre-treatment|Includes all subjects / eyes prior to the exposure to the investigational or control products
40508|NCT02157883|B1|Baseline|AZD9291 and Itraconozole (Part A); AZD9291 Alone (Part B)|"In Part A of the study, sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole. Each patient received single 80 mg oral doses of AZD9291 tablets on Days 1 and 10, and in addition received itraconazole capsules 200 mg twice daily on Days 6 to 18.
In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation."
40512|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40513|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40514|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40515|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40516|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40517|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40518|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40519|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40520|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40521|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40522|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40523|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40524|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40525|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40526|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40527|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40528|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40529|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40530|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40531|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40532|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
40533|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
40534|NCT02157883|E3|Reported Event|Part B Safety Population|In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
40535|NCT02157883|E2|Reported Event|Part A Safety Population|In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods (AZD9291 dosing on Days 1 and 10). Patients additionally received itraconazole 200 mg twice daily dosing from Days 6 to 18.
40536|NCT02157883|E1|Reported Event|Overall Safety Population|Parts A and B of the study combined.
40537|NCT02157623|B3|Baseline|Total|Total of all reporting groups
40538|NCT02157623|B2|Baseline|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application
Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields
Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
40539|NCT02157623|B1|Baseline|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application
Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields
Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
40540|NCT02157623|P2|Participant Flow|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application
Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields
Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
40541|NCT02157623|P1|Participant Flow|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application
Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields
Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
40542|NCT02157623|O2|Outcome|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application
Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields
Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
40543|NCT02157623|O1|Outcome|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application
Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields
Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
40544|NCT02157623|E2|Reported Event|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application
Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields
Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
40545|NCT02157623|E1|Reported Event|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application
Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields
Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
40546|NCT02157376|B3|Baseline|Total|Total of all reporting groups
40547|NCT02157376|B2|Baseline|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
40548|NCT02157376|B1|Baseline|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
40549|NCT02157376|P2|Participant Flow|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
74084|NCT01937260|B2|Baseline|Cohort 2|Brodalumab 140mg SC (Day1)
40551|NCT02157376|O2|Outcome|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
40552|NCT02157376|O1|Outcome|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
40553|NCT02157376|O2|Outcome|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
40554|NCT02157376|O1|Outcome|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
40555|NCT02157376|E2|Reported Event|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
40556|NCT02157376|E1|Reported Event|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
40557|NCT02157298|B3|Baseline|Total|Total of all reporting groups
40558|NCT02157298|B2|Baseline|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
40559|NCT02157298|B1|Baseline|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
40560|NCT02157298|P2|Participant Flow|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
40561|NCT02157298|P1|Participant Flow|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
40562|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
40563|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
40564|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
40565|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
40566|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
40567|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
40568|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
40569|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
40570|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
40571|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
40572|NCT02157298|E2|Reported Event|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
40573|NCT02157298|E1|Reported Event|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
40574|NCT02157116|B1|Baseline|All Subjects|All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
40575|NCT02157116|P1|Participant Flow|All Subjects|All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
40576|NCT02157116|O1|Outcome|Treated Patients|
40577|NCT02157116|O1|Outcome|Treated Patients|
40578|NCT02157116|O1|Outcome|Treated Patients|
40579|NCT02157116|O1|Outcome|Treated Patients|
40580|NCT02157116|O1|Outcome|Treated Patients|
40581|NCT02157116|O1|Outcome|Treated Patients|
40582|NCT02157116|E1|Reported Event|Treated Patients|Due to insufficient accrual, adverse event data was not analyzed.
40583|NCT02156466|B6|Baseline|Total|Total of all reporting groups
40584|NCT02156466|B5|Baseline|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40585|NCT02156466|B4|Baseline|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40586|NCT02156466|B3|Baseline|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40587|NCT02156466|B2|Baseline|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40588|NCT02156466|B1|Baseline|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40589|NCT02156466|P5|Participant Flow|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40590|NCT02156466|P4|Participant Flow|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40591|NCT02156466|P3|Participant Flow|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40592|NCT02156466|P2|Participant Flow|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40593|NCT02156466|P1|Participant Flow|MSB0010841 30 mg|MSB0010841 (Anti-Interleukin [IL]-17A/F Nanobody) was administered at a dose of 30 milligram (mg) as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40594|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40595|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40596|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40597|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40598|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40599|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40600|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40601|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40602|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40603|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40604|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week for a total duration of 6 weeks.
40605|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week for a total duration of 6 weeks.
40606|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week for a total duration of 6 weeks.
40607|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week for a total duration of 6 weeks.
40608|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 was administered at a dose of 30 mg as SC injection every other week for a total duration of 6 weeks.
40609|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40610|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40611|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40612|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40613|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40614|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40615|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40616|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40617|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40618|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40619|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40620|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40621|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40622|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40623|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40624|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40625|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40626|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40627|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40628|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40629|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40630|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40631|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40632|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40633|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40634|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40635|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40636|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40637|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40638|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40639|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40640|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40641|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40642|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40643|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40644|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40645|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40646|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40647|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40648|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40649|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40650|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40651|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40652|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40653|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40654|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40655|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40656|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40657|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40658|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40659|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40660|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40661|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40662|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40663|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40664|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40665|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40666|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40667|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40668|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40669|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40670|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40671|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40672|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40673|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40674|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40675|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40676|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40677|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40678|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40679|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40680|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40681|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40682|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40683|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40684|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40685|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40686|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40687|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40688|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40689|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40690|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40691|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40692|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40693|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40694|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40695|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40696|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40697|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40698|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40699|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40700|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40701|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40702|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40703|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40704|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40705|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40706|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40707|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40708|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40709|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40710|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40711|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40712|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40713|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40714|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40715|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40716|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40717|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40718|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40719|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40720|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40721|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40722|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40723|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40724|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40725|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40726|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40727|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40728|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40729|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40730|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40731|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40732|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40733|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40734|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40735|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40736|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40737|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40738|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40739|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40740|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40741|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40742|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40743|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40744|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40745|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40746|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40747|NCT02156466|O1|Outcome|ADA Positive Subjects|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration.
40748|NCT02156466|O1|Outcome|ADA Positive Subjects|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration.
40749|NCT02156466|O2|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40750|NCT02156466|O1|Outcome|MSB0010841 Combined|All subjects who received MSB0010841 (Anti-IL-17A/F Nanobody) at a dose of 30 mg, 60 mg, 120 mg or 240 mg as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks
40751|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40752|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40753|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40754|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40755|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40756|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40757|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40758|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40759|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40760|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40761|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40762|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40763|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40764|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40765|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40766|NCT02156466|E5|Reported Event|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40767|NCT02156466|E4|Reported Event|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40768|NCT02156466|E3|Reported Event|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40769|NCT02156466|E2|Reported Event|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40770|NCT02156466|E1|Reported Event|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
40771|NCT02156271|B3|Baseline|Total|Total of all reporting groups
40772|NCT02156271|B2|Baseline|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40773|NCT02156271|B1|Baseline|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40774|NCT02156271|P2|Participant Flow|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40775|NCT02156271|P1|Participant Flow|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40776|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40777|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40778|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40779|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
63626|NCT01990898|P1|Participant Flow|Treatment|Cyclosporine
40780|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40781|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40782|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40783|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40784|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40785|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40786|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40787|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40788|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40789|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40790|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40791|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40792|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40793|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40794|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40795|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40796|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40797|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40798|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40799|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40800|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40801|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40802|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40803|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40804|NCT02156271|E2|Reported Event|Placebo|"15 subjects will be randomized to receive the placebo
placebo"
40805|NCT02156271|E1|Reported Event|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
ramelteon"
40806|NCT02156167|B1|Baseline|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
40807|NCT02156167|P1|Participant Flow|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
40808|NCT02156167|O1|Outcome|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
40809|NCT02156167|E1|Reported Event|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
40810|NCT02155985|B4|Baseline|Total|Total of all reporting groups
40811|NCT02155985|B3|Baseline|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40812|NCT02155985|B2|Baseline|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40813|NCT02155985|B1|Baseline|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40814|NCT02155985|P3|Participant Flow|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40815|NCT02155985|P2|Participant Flow|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40816|NCT02155985|P1|Participant Flow|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40888|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
41129|NCT02153398|B5|Baseline|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
40817|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40818|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40819|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40820|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40821|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40822|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40823|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40824|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40825|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40826|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40827|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40828|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40829|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40830|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40831|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40832|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40833|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40834|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40835|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40836|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40837|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40838|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40889|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
63627|NCT01990898|O1|Outcome|Treatment|Cyclosporine
40839|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40840|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40841|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40842|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40843|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40844|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40845|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40846|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40847|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40848|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40849|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40850|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40851|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40852|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40853|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40854|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40855|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40856|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40857|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40858|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40859|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40860|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40890|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
63628|NCT01990898|E1|Reported Event|Treatment|Cyclosporine
40861|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40862|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40863|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40864|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40865|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40866|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40867|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40868|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40869|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40870|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40871|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40872|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40873|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40874|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40875|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40876|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40877|NCT02155985|E3|Reported Event|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Placebo for aspirin"
40878|NCT02155985|E2|Reported Event|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40879|NCT02155985|E1|Reported Event|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Aspirin
Placebo for aspirin"
40880|NCT02155881|B3|Baseline|Total|Total of all reporting groups
40881|NCT02155881|B2|Baseline|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
40882|NCT02155881|B1|Baseline|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
40883|NCT02155881|P2|Participant Flow|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
40884|NCT02155881|P1|Participant Flow|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
40885|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
40886|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
40887|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
40891|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
40892|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
40893|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
40894|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
40895|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
40896|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
40897|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
40898|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
40899|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
40900|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
40901|NCT02155881|E2|Reported Event|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
40902|NCT02155881|E1|Reported Event|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
40903|NCT02155543|B8|Baseline|Total|Total of all reporting groups
40904|NCT02155543|B7|Baseline|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
40905|NCT02155543|B6|Baseline|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
40906|NCT02155543|B5|Baseline|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
40907|NCT02155543|B4|Baseline|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
40908|NCT02155543|B3|Baseline|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
40909|NCT02155543|B2|Baseline|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
40910|NCT02155543|B1|Baseline|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
40911|NCT02155543|P7|Participant Flow|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
40912|NCT02155543|P6|Participant Flow|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
40913|NCT02155543|P5|Participant Flow|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
40914|NCT02155543|P4|Participant Flow|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
40915|NCT02155543|P3|Participant Flow|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
40916|NCT02155543|P2|Participant Flow|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
40917|NCT02155543|P1|Participant Flow|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
40918|NCT02155543|O4|Outcome|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
40919|NCT02155543|O3|Outcome|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
40920|NCT02155543|O2|Outcome|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
40921|NCT02155543|O1|Outcome|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
41110|NCT02153489|O2|Outcome|Placebo|Placebo BID
41111|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41112|NCT02153489|O2|Outcome|Placebo|Placebo BID
40949|NCT02155010|P1|Participant Flow|Dexmedetomidine Before Bupivacaine|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
40922|NCT02155543|E7|Reported Event|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
40923|NCT02155543|E6|Reported Event|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
40924|NCT02155543|E5|Reported Event|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
40925|NCT02155543|E4|Reported Event|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
40926|NCT02155543|E3|Reported Event|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
40927|NCT02155543|E2|Reported Event|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
40928|NCT02155543|E1|Reported Event|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
40929|NCT02155335|B1|Baseline|All Treated Participants|All participants who received at least 1 injection from either prefilled syringe or Smartject
40930|NCT02155335|P2|Participant Flow|Smartject™ Device→ Prefilled Syringe|Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
40931|NCT02155335|P1|Participant Flow|Prefilled Syringe→Smartject™ Device|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
40932|NCT02155335|O1|Outcome|Per Protocl Set (PPS)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire.
40933|NCT02155335|O1|Outcome|Per Protocl Set (PPS)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire.
40934|NCT02155335|E1|Reported Event|All Treated Participants|All participants who received at least 1 injection from either prefilled syringe or Smartject
40935|NCT02155322|B1|Baseline|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
40936|NCT02155322|P1|Participant Flow|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
40937|NCT02155322|O1|Outcome|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
40938|NCT02155322|O1|Outcome|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
40939|NCT02155322|E1|Reported Event|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
40940|NCT02155283|B1|Baseline|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)
Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
40941|NCT02155283|P1|Participant Flow|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)
Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
40942|NCT02155283|O1|Outcome|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)
Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
40943|NCT02155283|O1|Outcome|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)
Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
40944|NCT02155283|E1|Reported Event|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)
Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
40945|NCT02155010|B3|Baseline|Total|Total of all reporting groups
40946|NCT02155010|B2|Baseline|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine
Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
40947|NCT02155010|B1|Baseline|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
40948|NCT02155010|P2|Participant Flow|Dexmedetomidine After Bupivacaine|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine
Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
41113|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
40950|NCT02155010|O2|Outcome|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine
Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
40951|NCT02155010|O1|Outcome|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
40952|NCT02155010|O2|Outcome|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine
Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
40953|NCT02155010|O1|Outcome|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
40954|NCT02155010|E2|Reported Event|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine
Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
40955|NCT02155010|E1|Reported Event|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
40956|NCT02154906|B3|Baseline|Total|Total of all reporting groups
40957|NCT02154906|B2|Baseline|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect
autologous platelet rich fibrin"
40958|NCT02154906|B1|Baseline|DFDBA|"DFDBA used to graft intrabony defect
DFDBA"
40959|NCT02154906|P2|Participant Flow|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect
autologous platelet rich fibrin"
40960|NCT02154906|P1|Participant Flow|DFDBA|"DFDBA used to graft intrabony defect
DFDBA"
40961|NCT02154906|O2|Outcome|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect
autologous platelet rich fibrin"
40962|NCT02154906|O1|Outcome|DFDBA|"DFDBA used to graft intrabony defect
DFDBA"
40963|NCT02154906|O2|Outcome|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect
autologous platelet rich fibrin"
40964|NCT02154906|O1|Outcome|DFDBA|"DFDBA used to graft intrabony defect
DFDBA"
40965|NCT02154906|E2|Reported Event|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect
autologous platelet rich fibrin"
40966|NCT02154906|E1|Reported Event|DFDBA|"DFDBA used to graft intrabony defect
DFDBA"
41114|NCT02153489|O2|Outcome|Placebo|Placebo BID
41115|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
40997|NCT02154386|B3|Baseline|Total|Total of all reporting groups
40998|NCT02154386|B2|Baseline|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
40999|NCT02154386|B1|Baseline|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
41000|NCT02154386|P2|Participant Flow|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
41001|NCT02154386|P1|Participant Flow|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
41002|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
41003|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
41004|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
41005|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
41006|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
41007|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
41008|NCT02154386|E2|Reported Event|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
41009|NCT02154386|E1|Reported Event|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
41010|NCT02154243|B4|Baseline|Total|Total of all reporting groups
41011|NCT02154243|B3|Baseline|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
41012|NCT02154243|B2|Baseline|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.
Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
41013|NCT02154243|B1|Baseline|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.
Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
41014|NCT02154243|P3|Participant Flow|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
41015|NCT02154243|P2|Participant Flow|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.
Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
41016|NCT02154243|P1|Participant Flow|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.
Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
41017|NCT02154243|O3|Outcome|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
41018|NCT02154243|O2|Outcome|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.
Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
41019|NCT02154243|O1|Outcome|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.
Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
41020|NCT02154243|O3|Outcome|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
41021|NCT02154243|O2|Outcome|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.
Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
41022|NCT02154243|O1|Outcome|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.
Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
41023|NCT02154243|E3|Reported Event|Control (no Intervention)|Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
41024|NCT02154243|E2|Reported Event|Intravenous Fluid Bolus|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV>=15 will be given intravenous fluid bolus, 15 cc/kg, once.
Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session"
41025|NCT02154243|E1|Reported Event|Midodrine|"Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV<15 will be given oral midodrine, 10 mg, once.
Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session"
41026|NCT02154139|B1|Baseline|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
41027|NCT02154139|P1|Participant Flow|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
41028|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
41029|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
41030|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
41031|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
41032|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
41033|NCT02154139|E1|Reported Event|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
41034|NCT02154087|B1|Baseline|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
41035|NCT02154087|P1|Participant Flow|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
41036|NCT02154087|O1|Outcome|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
41037|NCT02154087|E1|Reported Event|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
41038|NCT02154048|B4|Baseline|Total|Total of all reporting groups
41039|NCT02154048|B3|Baseline|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
Ropivacaine + Dexamethasone + Placebo"
41116|NCT02153489|O2|Outcome|Placebo|Placebo BID
41117|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41118|NCT02153489|O2|Outcome|Placebo|Placebo BID
41040|NCT02154048|B2|Baseline|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.
Ropivacaine + Placebo"
41130|NCT02153398|B4|Baseline|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
81061|NCT01895946|B2|Baseline|Part B|Part B of the study
41041|NCT02154048|B1|Baseline|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.
Ropivacaine + Dexamethasone"
41042|NCT02154048|P3|Participant Flow|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
Ropivacaine + Dexamethasone + Placebo"
41043|NCT02154048|P2|Participant Flow|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.
Ropivacaine + Placebo"
41044|NCT02154048|P1|Participant Flow|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.
Ropivacaine + Dexamethasone"
41045|NCT02154048|O3|Outcome|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
Ropivacaine + Dexamethasone + Placebo"
41046|NCT02154048|O2|Outcome|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.
Ropivacaine + Dexamethasone"
41047|NCT02154048|O1|Outcome|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.
Ropivacaine + Placebo"
41048|NCT02154048|E3|Reported Event|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
Ropivacaine + Dexamethasone + Placebo"
41049|NCT02154048|E2|Reported Event|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.
Ropivacaine + Placebo"
41050|NCT02154048|E1|Reported Event|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.
Ropivacaine + Dexamethasone"
41051|NCT02153827|B3|Baseline|Total|Total of all reporting groups
41052|NCT02153827|B2|Baseline|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
41053|NCT02153827|B1|Baseline|Eccentric External Rotator Training|"Eccentric Shoulder External Rotator Training
Eccentric Shoulder External Rotator Training"
41054|NCT02153827|P2|Participant Flow|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
41055|NCT02153827|P1|Participant Flow|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
41056|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
41057|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
41058|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
41059|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
41060|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
41061|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
41062|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
41063|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
41064|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
41065|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
41066|NCT02153827|E2|Reported Event|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
41067|NCT02153827|E1|Reported Event|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
41068|NCT02153788|B3|Baseline|Total|Total of all reporting groups
41069|NCT02153788|B2|Baseline|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.
Placebo"
41070|NCT02153788|B1|Baseline|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.
Temazepam: Temazepam 15 mg orally at bedtime"
41071|NCT02153788|P2|Participant Flow|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.
Placebo"
41119|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41120|NCT02153489|O2|Outcome|Placebo|Placebo BID
41121|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41131|NCT02153398|B3|Baseline|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41132|NCT02153398|B2|Baseline|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41133|NCT02153398|B1|Baseline|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41072|NCT02153788|P1|Participant Flow|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.
Temazepam: Temazepam 15 mg orally at bedtime"
41073|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.
Placebo"
41074|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.
Temazepam: Temazepam 15 mg orally at bedtime"
41075|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.
Placebo"
41076|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.
Temazepam: Temazepam 15 mg orally at bedtime"
41077|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.
Placebo"
41078|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.
Temazepam: Temazepam 15 mg orally at bedtime"
41079|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.
Placebo"
41080|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.
Temazepam: Temazepam 15 mg orally at bedtime"
41081|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.
Placebo"
41082|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.
Temazepam: Temazepam 15 mg orally at bedtime"
41083|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.
Placebo"
41084|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.
Temazepam: Temazepam 15 mg orally at bedtime"
41085|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.
Placebo"
41086|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.
Temazepam: Temazepam 15 mg orally at bedtime"
41087|NCT02153788|E2|Reported Event|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.
Placebo"
41088|NCT02153788|E1|Reported Event|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.
Temazepam: Temazepam 15 mg orally at bedtime"
41089|NCT02153489|B1|Baseline|Overall Study|All patients participating in the crossover study
41090|NCT02153489|P2|Participant Flow|Sequence B|Placebo - Aclidinium 400 μg
41091|NCT02153489|P1|Participant Flow|Sequence A|Aclidinium 400 μg - Placebo
41092|NCT02153489|O2|Outcome|Placebo|Placebo BID
41093|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41094|NCT02153489|O2|Outcome|Placebo|Placebo BID
41095|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41096|NCT02153489|O2|Outcome|Placebo|Placebo BID
41097|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41098|NCT02153489|O2|Outcome|Placebo|Placebo BID
41099|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41100|NCT02153489|O2|Outcome|Placebo|Placebo BID
41101|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41102|NCT02153489|O2|Outcome|Placebo|Placebo BID
41103|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41104|NCT02153489|O2|Outcome|Placebo|Placebo BID
41105|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41106|NCT02153489|O2|Outcome|Placebo|Placebo BID
41107|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41108|NCT02153489|O2|Outcome|Placebo|Placebo BID
41109|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
41134|NCT02153398|P5|Participant Flow|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41135|NCT02153398|P4|Participant Flow|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41136|NCT02153398|P3|Participant Flow|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41137|NCT02153398|P2|Participant Flow|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41138|NCT02153398|P1|Participant Flow|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41139|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41140|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41141|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41142|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41143|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41144|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41145|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41146|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41147|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41148|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41149|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41150|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41151|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41152|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41153|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41154|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41155|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41156|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41157|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41158|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41159|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41160|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41161|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41162|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41163|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41164|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41165|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41166|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41167|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41168|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41169|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41170|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41171|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41172|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41173|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41174|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41175|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41176|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41177|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41178|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41179|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41180|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41181|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41182|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41183|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41184|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41185|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41186|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41187|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41188|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41189|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41190|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41191|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41192|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41193|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41194|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41195|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41196|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41197|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41198|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41199|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41200|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41201|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41202|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41203|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41204|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41205|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41206|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41207|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41208|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41209|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41210|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41211|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41212|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41213|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41214|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41215|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41216|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41217|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41218|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41219|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41220|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41221|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41222|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41223|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41224|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41225|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41226|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41227|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41228|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41229|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41230|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41231|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41232|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41233|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41234|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41235|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41236|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41237|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41238|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41239|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41240|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41241|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41242|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41243|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41244|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41245|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41246|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41247|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41248|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41249|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41250|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41251|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41252|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41253|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41254|NCT02153398|E5|Reported Event|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
41255|NCT02153398|E4|Reported Event|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
41256|NCT02153398|E3|Reported Event|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
41257|NCT02153398|E2|Reported Event|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
41258|NCT02153398|E1|Reported Event|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
41313|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
41259|NCT02153346|B1|Baseline|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
41260|NCT02153346|P1|Participant Flow|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
41261|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
41262|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
41263|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base. Only participants actively working who completed the questionnaires were included in the analysis of productivity.
41264|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
41265|NCT02153346|E1|Reported Event|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
41266|NCT02153099|B8|Baseline|Total|Total of all reporting groups
41267|NCT02153099|B7|Baseline|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
41268|NCT02153099|B6|Baseline|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
41269|NCT02153099|B5|Baseline|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
41270|NCT02153099|B4|Baseline|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
41271|NCT02153099|B3|Baseline|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
41272|NCT02153099|B2|Baseline|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
41273|NCT02153099|B1|Baseline|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
41274|NCT02153099|P7|Participant Flow|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
41275|NCT02153099|P6|Participant Flow|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
41276|NCT02153099|P5|Participant Flow|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
41277|NCT02153099|P4|Participant Flow|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
41278|NCT02153099|P3|Participant Flow|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
41279|NCT02153099|P2|Participant Flow|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
41280|NCT02153099|P1|Participant Flow|Cohort 4: TAK-058 5 mg|TAK-058 (ENV8058) 5 mg, 100 mL oral solution, once on Day 1.
41281|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
41282|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
41283|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
41284|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
41285|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
41286|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
41287|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
41288|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
41289|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
41290|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
41291|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
41292|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
41293|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
41294|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
41295|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
41296|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
41297|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
41298|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
41299|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
41300|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
41301|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
41302|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
41303|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
41304|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
41305|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
41306|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
41307|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
41308|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
41309|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
41310|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
41311|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
41312|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
41314|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
41315|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
41316|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
81062|NCT01895946|B1|Baseline|Part A|Part A of the study
41317|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
41318|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
41319|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
41320|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
41321|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
41322|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
41323|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
41324|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
41325|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
41326|NCT02153099|E7|Reported Event|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
41327|NCT02153099|E6|Reported Event|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
41328|NCT02153099|E5|Reported Event|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
41329|NCT02153099|E4|Reported Event|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
41330|NCT02153099|E3|Reported Event|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
41331|NCT02153099|E2|Reported Event|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
41332|NCT02153099|E1|Reported Event|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
41333|NCT02153086|B1|Baseline|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41334|NCT02153086|P1|Participant Flow|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41335|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41336|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41337|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41338|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41339|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41340|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41341|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41342|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41343|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41344|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41345|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41346|NCT02153086|E1|Reported Event|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
41347|NCT02152605|B3|Baseline|Total|Total of all reporting groups
41348|NCT02152605|B2|Baseline|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41349|NCT02152605|B1|Baseline|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41350|NCT02152605|P2|Participant Flow|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41351|NCT02152605|P1|Participant Flow|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41426|NCT02151994|O2|Outcome|400 mg Fed|BIA 5-1058 (5, 25 and 100 mg) tablets
41427|NCT02151994|O1|Outcome|400 mg Fasted|BIA 5-1058 (5, 25 and 100 mg) tablets
41352|NCT02152605|O2|Outcome|UMEC/VI 62.5/25mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41353|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41354|NCT02152605|O2|Outcome|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41355|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41356|NCT02152605|O2|Outcome|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41357|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41358|NCT02152605|E2|Reported Event|UMEC/VI 62.5/25mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41359|NCT02152605|E1|Reported Event|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
41360|NCT02152566|B1|Baseline|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.
Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
41361|NCT02152566|P1|Participant Flow|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.
Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
41362|NCT02152566|O1|Outcome|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.
Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
41363|NCT02152566|E1|Reported Event|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.
Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
41364|NCT02152371|B3|Baseline|Total|Total of all reporting groups
41365|NCT02152371|B2|Baseline|Placebo + Insulin Glargine|Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
41366|NCT02152371|B1|Baseline|Dulaglutide + Insulin Glargine|1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
41367|NCT02152371|P2|Participant Flow|Placebo + Insulin Glargine|Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
41368|NCT02152371|P1|Participant Flow|Dulaglutide + Insulin Glargine|1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
41369|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41428|NCT02151994|O6|Outcome|1200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
41429|NCT02151994|O5|Outcome|400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
41430|NCT02151994|O4|Outcome|200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
41431|NCT02151994|O3|Outcome|100 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
41370|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41371|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41372|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41373|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41374|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41375|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41376|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41377|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41378|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41379|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41380|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41381|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41382|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41383|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41384|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41385|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41386|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41387|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41388|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41389|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41432|NCT02151994|O2|Outcome|50 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
41433|NCT02151994|O1|Outcome|Placebo|Placebo : visually matching active medication
41434|NCT02151994|O10|Outcome|2400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
41390|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41391|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41392|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41393|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41394|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41395|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41396|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41397|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41398|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41399|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41400|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41401|NCT02152371|E2|Reported Event|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41402|NCT02152371|E1|Reported Event|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally"
41403|NCT02152007|B1|Baseline|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.
1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
41404|NCT02152007|P1|Participant Flow|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.
1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
41405|NCT02152007|O2|Outcome|Placebo Cream (Vehicle Control)|Placebo Cream (Vehicle Control)
41406|NCT02152007|O1|Outcome|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.
1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
41407|NCT02152007|O1|Outcome|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.
1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
41435|NCT02151994|O9|Outcome|1600 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
41436|NCT02151994|O8|Outcome|800 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
41437|NCT02151994|O7|Outcome|400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
41438|NCT02151994|O6|Outcome|200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
41443|NCT02151994|O1|Outcome|Placebo|Placebo : visually matching active medication
41444|NCT02151994|E18|Reported Event|1200 mg (MAD Period)|MAD period
41445|NCT02151994|E17|Reported Event|400 mg (MAD Period)|MAD period
41446|NCT02151994|E16|Reported Event|200 mg (MAD Period)|MAD period
41408|NCT02152007|E1|Reported Event|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.
1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
41409|NCT02151994|B4|Baseline|Total|Total of all reporting groups
41410|NCT02151994|B3|Baseline|Food Interaction (Food Effect, FE) Analysis|This part consisted of an eligibility screening period, an open-label two-way crossover study period, and a follow-up period. One group of 12 subjects received single doses of 400 mg BIA 5-1058 during 2 treatment periods, once after having fasted overnight and once after consumption of a high fat breakfast. Each treatment was separated by a period of at least 7 days. The treatment sequence was determined by randomisation.
41411|NCT02151994|B2|Baseline|Multiple Ascending Dose (MAD)|This part consisted of an eligibility screening period, one study period involving administration of multiple doses of BIA 5-1058 or placebo once daily for 10 days, and a follow-up period. Five sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo.
41412|NCT02151994|B1|Baseline|Single Ascending Dose (SAD)|This part consisted of an eligibility screening period, one study period involving administration of single doses of BIA 5-1058 or placebo according to a randomised design, and a follow-up period. Nine sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo.
41413|NCT02151994|P13|Participant Flow|400 mg Fed|BIA 5-1058 (5, 25 and 100 mg) tablets FE part: A single dose of 400 mg BIA 5-1058 on Day 1 under fasted (one period) and fed (one period) conditions.
41414|NCT02151994|P12|Participant Flow|400 mg Fasted|BIA 5-1058 (5, 25 and 100 mg) tablets FE part: A single dose of 400 mg BIA 5-1058 on Day 1 under fasted (one period) and fed (one period) conditions.
41415|NCT02151994|P11|Participant Flow|2400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
41416|NCT02151994|P10|Participant Flow|1600 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
41417|NCT02151994|P9|Participant Flow|1200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg.
41418|NCT02151994|P8|Participant Flow|800 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
41419|NCT02151994|P7|Participant Flow|400 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
41420|NCT02151994|P6|Participant Flow|200 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
41421|NCT02151994|P5|Participant Flow|100 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
41422|NCT02151994|P4|Participant Flow|50 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
41423|NCT02151994|P3|Participant Flow|25 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
41424|NCT02151994|P2|Participant Flow|5 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
41425|NCT02151994|P1|Participant Flow|Placebo|Placebo : visually matching active medication
41463|NCT02151981|B2|Baseline|Chemotherapy|Platinum-based doublet chemotherapy
41464|NCT02151981|B1|Baseline|AZD9291 80 mg|Daily single dose of AZD9291 80mg
41465|NCT02151981|P2|Participant Flow|Chemotherapy|Platinum-based doublet chemotherapy
41466|NCT02151981|P1|Participant Flow|AZD9291 80 mg|Daily single dose of AZD9291 80mg
41467|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
41468|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
41469|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
41470|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
41471|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
41472|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
41473|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
41474|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
41475|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
41476|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
41477|NCT02151981|O2|Outcome|Chemotherapy|Platinum-based doublet chemotherapy
41478|NCT02151981|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
41479|NCT02151981|E2|Reported Event|Chemotherapy|Platinum-based doublet chemotherapy
41480|NCT02151981|E1|Reported Event|AZD9291 80 mg|Daily single dose of AZD9291 80mg
41481|NCT02151786|B1|Baseline|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
41482|NCT02151786|P1|Participant Flow|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
41483|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
41484|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
41485|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
41486|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
41487|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
41488|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
41489|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
41490|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
41491|NCT02151786|E1|Reported Event|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
41492|NCT02151773|B1|Baseline|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
41493|NCT02151773|P1|Participant Flow|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 milliliter (mL), injection, subcutaneously as a single dose as per routine medical practice were observed.
41494|NCT02151773|O1|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
41495|NCT02151773|O1|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
41496|NCT02151773|E1|Reported Event|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
41497|NCT02151253|B1|Baseline|All Randomized Participants|
41548|NCT02151058|E1|Reported Event|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41549|NCT02150954|B3|Baseline|Total|Total of all reporting groups
41550|NCT02150954|B2|Baseline|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
66859|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
41498|NCT02151253|P2|Participant Flow|Placebo First, Then Armodafinil|"During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am.
Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects."
41499|NCT02151253|P1|Participant Flow|Armodafinil First, Then Placebo|"During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am.
Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects."
41513|NCT02151058|B3|Baseline|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
42526|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
41500|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
41501|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
41502|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
41503|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
41504|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
41505|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
41506|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
41507|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
41508|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
41509|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
42665|NCT02141997|B2|Baseline|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
41510|NCT02151253|E2|Reported Event|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
41511|NCT02151253|E1|Reported Event|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
41512|NCT02151058|B4|Baseline|Total|Total of all reporting groups
41608|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
41514|NCT02151058|B2|Baseline|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41515|NCT02151058|B1|Baseline|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41516|NCT02151058|P3|Participant Flow|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
41517|NCT02151058|P2|Participant Flow|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41518|NCT02151058|P1|Participant Flow|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41519|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
41520|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41521|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41522|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
41523|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41524|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41525|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
41526|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41527|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41528|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
41529|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41530|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41531|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
41532|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41533|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41534|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
41535|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41536|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41537|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
41538|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41539|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41540|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
41541|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41542|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41543|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
41544|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41545|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
41546|NCT02151058|E3|Reported Event|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
41547|NCT02151058|E2|Reported Event|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
41551|NCT02150954|B1|Baseline|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41552|NCT02150954|P2|Participant Flow|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
41553|NCT02150954|P1|Participant Flow|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41554|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
41555|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41556|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
41609|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
41557|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41558|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
41559|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41560|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
41561|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41562|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
41563|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41564|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
41565|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41566|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
41567|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41568|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
41569|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41570|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
41571|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41572|NCT02150954|E2|Reported Event|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin"
41573|NCT02150954|E1|Reported Event|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin"
41574|NCT02150499|B3|Baseline|Total|Total of all reporting groups
41575|NCT02150499|B2|Baseline|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
levalbuterol tartrate HFA inhalation aerosol"
41576|NCT02150499|B1|Baseline|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
levalbuterol tartrate HFA inhalation aerosol
placebo"
41577|NCT02150499|P2|Participant Flow|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
levalbuterol tartrate HFA inhalation aerosol"
41578|NCT02150499|P1|Participant Flow|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
levalbuterol tartrate HFA inhalation aerosol
placebo"
41579|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
levalbuterol tartrate HFA inhalation aerosol"
41580|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
levalbuterol tartrate HFA inhalation aerosol
placebo"
41581|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
levalbuterol tartrate HFA inhalation aerosol"
41582|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
levalbuterol tartrate HFA inhalation aerosol
placebo"
41610|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
41611|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
41583|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
levalbuterol tartrate HFA inhalation aerosol"
41584|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
levalbuterol tartrate HFA inhalation aerosol
placebo"
41585|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
levalbuterol tartrate HFA inhalation aerosol"
41586|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
levalbuterol tartrate HFA inhalation aerosol
placebo"
41587|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
levalbuterol tartrate HFA inhalation aerosol"
41588|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
levalbuterol tartrate HFA inhalation aerosol
placebo"
41589|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
levalbuterol tartrate HFA inhalation aerosol"
41590|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
levalbuterol tartrate HFA inhalation aerosol
placebo"
41591|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
levalbuterol tartrate HFA inhalation aerosol"
41592|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
levalbuterol tartrate HFA inhalation aerosol
placebo"
41593|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
levalbuterol tartrate HFA inhalation aerosol"
41594|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
levalbuterol tartrate HFA inhalation aerosol
placebo"
41595|NCT02150499|E2|Reported Event|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
levalbuterol tartrate HFA inhalation aerosol"
41596|NCT02150499|E1|Reported Event|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
levalbuterol tartrate HFA inhalation aerosol
placebo"
41597|NCT02150460|B3|Baseline|Total|Total of all reporting groups
41598|NCT02150460|B2|Baseline|Two-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments
Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments"
41599|NCT02150460|B1|Baseline|One-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment
One-site peribulbar injection: injection into the inferior medial orbital compartment"
41600|NCT02150460|P2|Participant Flow|Two-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments
Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments"
41601|NCT02150460|P1|Participant Flow|One-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment
One-site peribulbar injection: injection into the inferior medial orbital compartment"
41602|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
41603|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
41604|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
41605|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
41606|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
41607|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
41624|NCT02150213|B1|Baseline|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
41625|NCT02150213|P1|Participant Flow|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
41626|NCT02150213|O1|Outcome|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
41627|NCT02150213|O1|Outcome|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
41628|NCT02150213|E1|Reported Event|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
41629|NCT02150109|B1|Baseline|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH (329) and WITHOUT (43) diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
41630|NCT02150109|P1|Participant Flow|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
41631|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
41632|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
41633|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
41634|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
66860|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
41635|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
41636|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes (329) used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
41637|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood (329 WITH Diabetes) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
41638|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject venous blood from subjects WITH Diabetes (329) and BG results were compared to reference method results obtained from subject venous plasma."
41639|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
41715|NCT02148718|P1|Participant Flow|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
81063|NCT01895946|P2|Participant Flow|Part B|Part B of the study
41640|NCT02150109|E1|Reported Event|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
41641|NCT02150044|B1|Baseline|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system
Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
41642|NCT02150044|P1|Participant Flow|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system
Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
41643|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system
Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
41644|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system
Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
41645|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system
Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
41646|NCT02150044|E1|Reported Event|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system
Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
41647|NCT02149875|B4|Baseline|Total|Total of all reporting groups
41648|NCT02149875|B3|Baseline|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
41649|NCT02149875|B2|Baseline|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
41650|NCT02149875|B1|Baseline|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
41651|NCT02149875|P3|Participant Flow|Placebo|"Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
41652|NCT02149875|P2|Participant Flow|Cerebrolysin|"Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
41653|NCT02149875|P1|Participant Flow|Dl-3-n-butylphthalide|"Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
41654|NCT02149875|O3|Outcome|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
41655|NCT02149875|O2|Outcome|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
41656|NCT02149875|O1|Outcome|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
41657|NCT02149875|O3|Outcome|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
41658|NCT02149875|O2|Outcome|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
41659|NCT02149875|O1|Outcome|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
41660|NCT02149875|E3|Reported Event|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
41661|NCT02149875|E2|Reported Event|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
41662|NCT02149875|E1|Reported Event|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
41663|NCT02149342|B1|Baseline|Hexylaminolaevulinate and Methylaminoalevulinate Cream|0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and 16% methylaminolaevulinate (Metvix, Galderma) in a split-face design
41664|NCT02149342|P1|Participant Flow|Hexylaminolaevulinate and Methylaminoalevulinate Creams|"0,2% hexylaminolaevulinate cream , HAL (Hexvix, Photocure, Unguentum M, Almirall) 16% methylaminolaevulinate, MAL (Metvix, Galderma)
HAL and MAL used as photosensitizer for daylight-PDT in a randomized split-face design"
41665|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)
Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
41783|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
41666|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)
Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
41667|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)
Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
41668|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)
Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
41669|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)
Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
41670|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)
Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
41671|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)
Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
41672|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral)
Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream"
41673|NCT02149342|E2|Reported Event|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)
Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
41716|NCT02148718|O1|Outcome|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
41674|NCT02149342|E1|Reported Event|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)
Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
41675|NCT02149303|B1|Baseline|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
41676|NCT02149303|P1|Participant Flow|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
41677|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
41678|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
41679|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
41680|NCT02149303|E1|Reported Event|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
41681|NCT02149264|B1|Baseline|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41682|NCT02149264|P1|Participant Flow|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41683|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41684|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41685|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41686|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41687|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41784|NCT02148107|O3|Outcome|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
41688|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41689|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41690|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41691|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41692|NCT02149264|O1|Outcome|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41693|NCT02149264|E1|Reported Event|Testosterone Gel (FE 999303)|Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
41694|NCT02149108|B3|Baseline|Total|Total of all reporting groups
42527|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
41695|NCT02149108|B2|Baseline|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41696|NCT02149108|B1|Baseline|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41697|NCT02149108|P2|Participant Flow|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41698|NCT02149108|P1|Participant Flow|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41699|NCT02149108|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41700|NCT02149108|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41701|NCT02149108|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41702|NCT02149108|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41703|NCT02149108|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41704|NCT02149108|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41705|NCT02149108|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41706|NCT02149108|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41707|NCT02149108|E2|Reported Event|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41708|NCT02149108|E1|Reported Event|Placebo|Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
41785|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
41786|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
41709|NCT02148809|B1|Baseline|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).
Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.
All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
41710|NCT02148809|P1|Participant Flow|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).
Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.
All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
41711|NCT02148809|O1|Outcome|Pilot Study|14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study
41712|NCT02148809|O1|Outcome|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).
Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.
All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
41713|NCT02148809|E1|Reported Event|Pilot Study|14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study
41714|NCT02148718|B1|Baseline|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
41717|NCT02148718|E1|Reported Event|Adalimumab|Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
41718|NCT02148523|B4|Baseline|Total|Total of all reporting groups
41719|NCT02148523|B3|Baseline|Usual Care|"Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41720|NCT02148523|B2|Baseline|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
Comparison to peers
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41721|NCT02148523|B1|Baseline|Weekly Adherence Report|"Adherence report to subject every 7 days.
Adherence feedback
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41722|NCT02148523|P3|Participant Flow|Usual Care|"Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41723|NCT02148523|P2|Participant Flow|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
Comparison to peers
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41724|NCT02148523|P1|Participant Flow|Weekly Adherence Report|"Adherence report to subject every 7 days.
Adherence feedback
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41725|NCT02148523|O3|Outcome|Usual Care|"Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41726|NCT02148523|O2|Outcome|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
Comparison to peers
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41727|NCT02148523|O1|Outcome|Weekly Adherence Report|"Adherence report to subject every 7 days.
Adherence feedback
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41728|NCT02148523|O3|Outcome|Usual Care|"Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41729|NCT02148523|O2|Outcome|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
Comparison to peers
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41730|NCT02148523|O1|Outcome|Weekly Adherence Report|"Adherence report to subject every 7 days.
Adherence feedback
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41731|NCT02148523|E3|Reported Event|Usual Care|"Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41732|NCT02148523|E2|Reported Event|Weekly Adherence Peer-Comparison Report|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.
Comparison to peers
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41733|NCT02148523|E1|Reported Event|Weekly Adherence Report|"Adherence report to subject every 7 days.
Adherence feedback
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
41734|NCT02148445|B3|Baseline|Total|Total of all reporting groups
41821|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41735|NCT02148445|B2|Baseline|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41736|NCT02148445|B1|Baseline|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41737|NCT02148445|P2|Participant Flow|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41738|NCT02148445|P1|Participant Flow|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41739|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41740|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
42528|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
41741|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41742|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41743|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41744|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41745|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41746|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41747|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41748|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41749|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41750|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41751|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41752|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41753|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41754|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41755|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41756|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41757|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41758|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41759|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41760|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41761|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41762|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41763|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41764|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41765|NCT02148445|O2|Outcome|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41766|NCT02148445|O1|Outcome|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41767|NCT02148445|E2|Reported Event|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
41768|NCT02148445|E1|Reported Event|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
41769|NCT02148107|B4|Baseline|Total|Total of all reporting groups
41770|NCT02148107|B3|Baseline|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
41771|NCT02148107|B2|Baseline|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
41772|NCT02148107|B1|Baseline|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
41773|NCT02148107|P3|Participant Flow|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
41774|NCT02148107|P2|Participant Flow|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
41775|NCT02148107|P1|Participant Flow|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
41776|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
41777|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
41778|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
41779|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
41780|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
41781|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
41782|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
42083|NCT02146248|O1|Outcome|HSG 4|DMPA HSG
41787|NCT02148107|E3|Reported Event|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
41788|NCT02148107|E2|Reported Event|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
41789|NCT02148107|E1|Reported Event|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
41790|NCT02147691|B3|Baseline|Total|Total of all reporting groups
41791|NCT02147691|B2|Baseline|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidine 0.33%"
41792|NCT02147691|B1|Baseline|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41793|NCT02147691|P2|Participant Flow|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidine 0.33%"
41794|NCT02147691|P1|Participant Flow|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 0.33 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41795|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41796|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41797|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
42529|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
41798|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41799|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41800|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41801|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41802|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41803|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41804|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41805|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41806|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41807|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41808|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41809|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41810|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41811|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41812|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41813|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41814|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41815|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41816|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41817|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41818|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41819|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41820|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
42084|NCT02146248|O1|Outcome|HSG 3|OC HSG
41822|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41823|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41824|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41825|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41826|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41827|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41828|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41829|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41890|NCT02146482|B1|Baseline|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
41830|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41831|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41832|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41833|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41834|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41835|NCT02147691|E2|Reported Event|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%"
41836|NCT02147691|E1|Reported Event|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face
Finacea 15 % Gel (azelaic acid 15%) each evening to the face
Azelaic acid 15%
Brimonidine 0.33%"
41837|NCT02147561|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
41838|NCT02147561|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
41839|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
41840|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
41841|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
41842|NCT02147561|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
41843|NCT02147522|B3|Baseline|Total|Total of all reporting groups
41844|NCT02147522|B2|Baseline|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers.
PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
41845|NCT02147522|B1|Baseline|A Helping Hand (AHH)|Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
41846|NCT02147522|P2|Participant Flow|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic usual care from their respective county health clinic providers.
PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
41847|NCT02147522|P1|Participant Flow|A Helping Hand (AHH)|Participants received PCMH depression care services from their respective county health clinic providers plus the AHH intervention. Promotoras provided 6 weekly in-person or via-telephone intervention followed by 3 monthly telephone sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
41848|NCT02147522|O2|Outcome|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers.
PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
41849|NCT02147522|O1|Outcome|A Helping Hand (AHH)|Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
41850|NCT02147522|O2|Outcome|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers.
PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
41851|NCT02147522|O1|Outcome|A Helping Hand (AHH)|Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
41852|NCT02147522|O2|Outcome|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers.
PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
41891|NCT02146482|P2|Participant Flow|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work
Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
42530|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
41853|NCT02147522|O1|Outcome|A Helping Hand (AHH)|Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
41854|NCT02147522|E2|Reported Event|Usual Care (UC)|"Participants received DHS Patient Centered Medical Home (PCMH) clinic usual care from their respective county health clinic providers.
PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics."
41855|NCT02147522|E1|Reported Event|A Helping Hand (AHH)|Participants received PCMH depression care services from their respective county health clinic providers plus the AHH intervention. Promotoras provided 6 weekly in-person or via-telephone intervention followed by 3 monthly telephone sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
41856|NCT02147288|B3|Baseline|Total|Total of all reporting groups
41857|NCT02147288|B2|Baseline|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.
Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
41858|NCT02147288|B1|Baseline|Panniculectomy on JP Drains|Standard of Care
41859|NCT02147288|P10|Participant Flow|Ventral Hernia Repair (VHR) on JP Drains|
41860|NCT02147288|P9|Participant Flow|Ventral Hernia Repair (VHR) on NPWT|
41861|NCT02147288|P8|Participant Flow|Abdominoplasty on JP Drains|
41862|NCT02147288|P7|Participant Flow|Abdominoplasty on NPWT|
41863|NCT02147288|P6|Participant Flow|Lipoabdominoplasty on JP Drains|
41864|NCT02147288|P5|Participant Flow|Lipoabdominoplasty on NPWT|
41865|NCT02147288|P4|Participant Flow|Breast Recon With ADM on Jackson-Pratt (JP) Drains|
41866|NCT02147288|P3|Participant Flow|Breast Recon With Acellular Dermal Matrix (ADM) on NPWT|
41867|NCT02147288|P2|Participant Flow|Panniculectomy on Negative Pressure Wound Therapy (NPWT)|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.
Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
41868|NCT02147288|P1|Participant Flow|Panniculectomy on Jackson Pratt (JP) Drains|Standard of Care
41869|NCT02147288|O2|Outcome|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.
Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
41870|NCT02147288|O1|Outcome|Panniculectomy on JP Drains|Standard of Care
41871|NCT02147288|E2|Reported Event|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.
Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
41872|NCT02147288|E1|Reported Event|Panniculectomy on JP Drains|Standard of Care
41873|NCT02147093|B3|Baseline|Total|Total of all reporting groups
41874|NCT02147093|B2|Baseline|Test (Filcon II 3-multi-focal) / Control (Filcon II 3-spher)|All subjects that were randomized to sequence and were dispensed a study lens.
41875|NCT02147093|B1|Baseline|Control (Filcon II 3-sphere) /Test (Filcon II 3-multi-focal)|All subjects that were randomized to sequence and were dispensed a study lens.
41876|NCT02147093|P2|Participant Flow|Test (Filcon II 3-multi-focal) /Control (Filcon II 3- Sphere)|Subjects were first fitted with the Test lens (filcon II 3-multi-focal) for one week. Subjects were then fitted with Control lens (filcon II 3- sphere) and a pair of reading glasses for one week.
41877|NCT02147093|P1|Participant Flow|Control (Filcon II 3- Sphere) /Test (Filcon II 3-multi-focal)|Subjects were first fitted with the Control lens (filcon II 3- sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (filcon II 3-multi-focal) for one week.
41878|NCT02147093|O2|Outcome|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
41879|NCT02147093|O1|Outcome|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
41880|NCT02147093|O2|Outcome|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
41881|NCT02147093|O1|Outcome|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
41882|NCT02147093|E2|Reported Event|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
41883|NCT02147093|E1|Reported Event|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
41884|NCT02146599|B1|Baseline|Pseudophakic|Administration of patient self assessment
41885|NCT02146599|P1|Participant Flow|Pseudophakic|Administration of patient self assessment
41886|NCT02146599|O1|Outcome|Pseudophakic|Administration of patient self assessment
41887|NCT02146599|E1|Reported Event|Pseudophakic|Administration of patient self assessment
41888|NCT02146482|B3|Baseline|Total|Total of all reporting groups
41889|NCT02146482|B2|Baseline|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work
Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
41892|NCT02146482|P1|Participant Flow|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
41893|NCT02146482|O2|Outcome|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work
Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
41894|NCT02146482|O1|Outcome|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
41895|NCT02146482|E2|Reported Event|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work
Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
41896|NCT02146482|E1|Reported Event|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
41897|NCT02146352|B1|Baseline|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41898|NCT02146352|P1|Participant Flow|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41899|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41900|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41901|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41902|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41903|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41904|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41905|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41906|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41907|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41908|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41909|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41910|NCT02146352|E1|Reported Event|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System
AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
41911|NCT02146326|B5|Baseline|Total|Total of all reporting groups
41912|NCT02146326|B4|Baseline|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41913|NCT02146326|B3|Baseline|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41914|NCT02146326|B2|Baseline|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41915|NCT02146326|B1|Baseline|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41916|NCT02146326|P4|Participant Flow|Motivational Interviewing-Clients|"Clients linked to staff randomized to the MI intervention:
Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months."
41917|NCT02146326|P3|Participant Flow|BREATHE-Clients|"Clients linked to staff randomized to the BREATHE intervention:
Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months."
41918|NCT02146326|P2|Participant Flow|Motivational Interviewing-Mental Health Care Staff|"Mental Health Care Staff randomized to the Motivational Interviewing (MI) intervention:
Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
41919|NCT02146326|P1|Participant Flow|BREATHE-Mental Health Care Staff|"Mental Health Care Staff randomized to the Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE) intervention:
Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
41920|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41921|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41922|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41923|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41924|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41925|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41926|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41927|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41928|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41929|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41930|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41931|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41932|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41933|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42085|NCT02146248|O1|Outcome|Tubal Patency Change|Change in tubal patency after OC treatment
42086|NCT02146248|O1|Outcome|Follicular Phase HSG|
41934|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41935|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41936|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41937|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41938|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41939|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41940|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41941|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41942|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41943|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41944|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41945|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41946|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41947|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41948|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41949|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41950|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41951|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41952|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41953|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41954|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41955|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41956|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41957|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41958|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41959|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41960|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41961|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41962|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41963|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41964|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42531|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
41965|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41966|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41967|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41968|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41969|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41970|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41971|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41972|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41973|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41974|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41975|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41976|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention Clients: were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41977|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41978|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41979|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41980|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41981|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41982|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41983|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41984|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41985|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41986|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41987|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41988|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41989|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42532|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
41990|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41991|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41992|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41993|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41994|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41995|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41996|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41997|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
41998|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
41999|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42000|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42001|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42002|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42003|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42004|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention Clients: were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42005|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42006|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42007|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42008|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42129|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
42009|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42010|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42011|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42012|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42013|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42295|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.
Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
42014|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42015|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42016|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42017|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42018|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42019|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42020|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42021|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42022|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42023|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42024|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42025|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42026|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42027|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42028|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42029|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42030|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42031|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42032|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42033|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42130|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
42034|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42035|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42036|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42037|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42296|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.
DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
42038|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42039|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42040|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|"Clients linked to staff randomized to the MI intervention:
Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months"
42041|NCT02146326|O3|Outcome|BREATHE-Clients|"Clients linked to staff randomized to the BREATHE intervention:
Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months"
42042|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|"Mental Health Care Staff randomized to the MI intervention:
Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
42043|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|"Mental Health Care Staff randomized to the BREATHE intervention:
Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
42044|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42045|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42046|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42047|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42048|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42049|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42050|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42051|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42052|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42053|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42054|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42055|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42056|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42057|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42058|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42059|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42060|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42061|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42062|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42063|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42064|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42065|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42066|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42067|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42068|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42069|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42070|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42071|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42072|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42073|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42074|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42075|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42076|NCT02146326|E4|Reported Event|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42077|NCT02146326|E3|Reported Event|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
42078|NCT02146326|E2|Reported Event|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42079|NCT02146326|E1|Reported Event|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
42080|NCT02146248|B1|Baseline|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).
2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.
Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption
DepoProvera: injectable hormonal contraceptive"
42081|NCT02146248|P1|Participant Flow|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).
2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.
Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption
DepoProvera: injectable hormonal contraceptive"
42082|NCT02146248|O1|Outcome|HSG 5|post DMPA OC HSG
42087|NCT02146248|E1|Reported Event|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).
2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.
Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption
DepoProvera: injectable hormonal contraceptive"
42088|NCT02146105|B1|Baseline|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.
Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
42089|NCT02146105|P1|Participant Flow|Yoga Intervention|Participants completed a yoga strengthening program designed for knee osteoarthritis (OA). This program was taught by a certified yoga instructor who was trained to deliver the strengthening program. Participants were asked to attend 3 classes per week for 12 weeks. Each class was 1 hour in duration.
42090|NCT02146105|O1|Outcome|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.
Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
42091|NCT02146105|E1|Reported Event|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.
Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
42092|NCT02146001|B3|Baseline|Total|Total of all reporting groups
42093|NCT02146001|B2|Baseline|Sit Less|Targeting 1 hour less of sedentary time per day
42094|NCT02146001|B1|Baseline|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
42095|NCT02146001|P2|Participant Flow|Sit Less|Targeting 1 hour less of sedentary time per day
42096|NCT02146001|P1|Participant Flow|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
42097|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
42098|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
42099|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
42100|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
42101|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
42102|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
42103|NCT02146001|E2|Reported Event|Sit Less|Targeting 1 hour less of sedentary time per day
42104|NCT02146001|E1|Reported Event|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
42105|NCT02145754|B1|Baseline|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media
MKP media versus BSK-H media"
42106|NCT02145754|P1|Participant Flow|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-h media
MKP media versus BSK-H media"
42107|NCT02145754|O1|Outcome|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media
MKP media versus BSK-H media"
42108|NCT02145754|E1|Reported Event|MKP Media Versus BSK-h Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media
MKP media versus BSK-H media"
42109|NCT02145676|B4|Baseline|Total|Total of all reporting groups
42110|NCT02145676|B3|Baseline|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
42111|NCT02145676|B2|Baseline|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
42112|NCT02145676|B1|Baseline|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
42113|NCT02145676|P3|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
42114|NCT02145676|P2|Participant Flow|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
42115|NCT02145676|P1|Participant Flow|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
42116|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
42117|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
42118|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
42119|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
42120|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
42121|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
42122|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
42123|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
42124|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
42125|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
42126|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
42127|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
42128|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
42131|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
42132|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
42133|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
42134|NCT02145676|E3|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
42135|NCT02145676|E2|Reported Event|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
42136|NCT02145676|E1|Reported Event|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
42137|NCT02145468|B3|Baseline|Total|Total of all reporting groups
42297|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
42684|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
42138|NCT02145468|B2|Baseline|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42139|NCT02145468|B1|Baseline|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42140|NCT02145468|P2|Participant Flow|Losmapimod 7.5 Mllligrms BID|Participants received losmapimod 7.5 milligrams (mg) tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42141|NCT02145468|P1|Participant Flow|Placebo|Participants received losmapimod matching placebo tablets via oral route, twice daily (BID), according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42142|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42143|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42144|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42145|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42146|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42147|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42148|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42149|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42150|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42151|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42152|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42153|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42154|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42155|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42156|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42289|NCT02144259|P2|Participant Flow|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.
Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
42157|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42158|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42159|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
81064|NCT01895946|P1|Participant Flow|Part A|Part A of the study
42160|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42161|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42162|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42163|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42164|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42165|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42166|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42167|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42168|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42169|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42170|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42171|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42172|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42173|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42174|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42175|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42176|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42177|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42178|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42179|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42180|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42181|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42182|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42183|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42184|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42185|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42186|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42187|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42188|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42189|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42190|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42191|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42192|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42193|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42194|NCT02145468|E2|Reported Event|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42195|NCT02145468|E1|Reported Event|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
42196|NCT02145299|B3|Baseline|Total|Total of all reporting groups
42197|NCT02145299|B2|Baseline|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42198|NCT02145299|B1|Baseline|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42199|NCT02145299|P2|Participant Flow|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42290|NCT02144259|P1|Participant Flow|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.
DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
42291|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
42200|NCT02145299|P1|Participant Flow|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42533|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42201|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42202|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42203|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42204|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42205|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42206|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42207|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42208|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42209|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42210|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42211|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42298|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.
Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
42299|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.
DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
42212|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42213|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42214|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42215|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42216|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42217|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42218|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42219|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42220|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42221|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42292|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.
Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
42293|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.
DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
42300|NCT02144259|E3|Reported Event|Control Group|Subjects selecting their own method of contraception or no contraception.
42301|NCT02144259|E2|Reported Event|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.
Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
42222|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42223|NCT02145299|E2|Reported Event|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
CROSSER CTO Device"
42224|NCT02145299|E1|Reported Event|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
42225|NCT02145156|B4|Baseline|Total|Total of all reporting groups
42226|NCT02145156|B3|Baseline|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42227|NCT02145156|B2|Baseline|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42228|NCT02145156|B1|Baseline|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42229|NCT02145156|P3|Participant Flow|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42230|NCT02145156|P2|Participant Flow|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42231|NCT02145156|P1|Participant Flow|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42232|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42233|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42234|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42235|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42236|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42237|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42238|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42239|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42240|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42241|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42242|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42243|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42244|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42245|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42246|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42247|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42248|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42263|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42249|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42250|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42251|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42252|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42253|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42254|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42255|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42256|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42257|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42258|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42259|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42260|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42261|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42262|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
74106|NCT01937130|B2|Baseline|IDN-6556 25 mg|"Dosed twice daily
IDN-6556"
42264|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42265|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42266|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42267|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42268|NCT02145156|E3|Reported Event|Usual Care|"Intervention: Survey-only. Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
42269|NCT02145156|E2|Reported Event|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
42270|NCT02145156|E1|Reported Event|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
42271|NCT02144337|B3|Baseline|Total|Total of all reporting groups
42272|NCT02144337|B2|Baseline|Normal Daily Activity|Treatment as usual: children asked to continue normal daily activity as usual.
42273|NCT02144337|B1|Baseline|Steps To Active Kids (STAK) Programme|"6 week Steps To Active Kids (STAK) physical activity programme (combined supervised and home-based physical activity).
Steps To Active Kids (STAK) Programme: 6 week programme of combined supervised and home-based (non-supervised) physical activity."
42274|NCT02144337|P2|Participant Flow|Control Group|Control group. Children in the Control group are asked to continue normal daily activities.
42275|NCT02144337|P1|Participant Flow|Intervention Group|6 week Steps To Active Kids (STAK) programme includes: StreetDance DVD designed to be completed at home (4 weeks in total). A dance routine is taught over 4 weeks with new elements introduced each day. Activity diary aims to encourage children to record daily activities in a logbook and to educate children about physical activity. Step counter: Children are given a pedometer and encouraged to record steps in the activity diary and to set personal goals to increase their steps. Weekly group activity sessions for 4 – 6 weeks. Involve a circuit of activity stations varying in intensity. The group sessions are designed to be fun and non-competitive. Children can record their scores at each station and monitor their own progress.
42276|NCT02144337|O1|Outcome|Overall Study Group Sample|Intervention and control group combined
42277|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
42278|NCT02144337|O2|Outcome|Control Group|No intervention
42279|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
42280|NCT02144337|O2|Outcome|Control Group|No intervention
42281|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
42282|NCT02144337|E2|Reported Event|Normal Daily Activity|Treatment as usual: children asked to continue normal daily activity as usual.
42283|NCT02144337|E1|Reported Event|Steps To Active Kids (STAK) Programme|"6 week Steps To Active Kids (STAK) physical activity programme (combined supervised and home-based physical activity).
Steps To Active Kids (STAK) Programme: 6 week programme of combined supervised and home-based (non-supervised) physical activity."
42284|NCT02144259|B4|Baseline|Total|Total of all reporting groups
42285|NCT02144259|B3|Baseline|Control Group|Subjects selecting their own method of contraception or no contraception.
42286|NCT02144259|B2|Baseline|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.
Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
42287|NCT02144259|B1|Baseline|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.
DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
42288|NCT02144259|P3|Participant Flow|Control Group|Subjects selecting their own method of contraception or no contraception.
42294|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
42302|NCT02144259|E1|Reported Event|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.
DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
42303|NCT02144220|B1|Baseline|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.
Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
42304|NCT02144220|P1|Participant Flow|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.
Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
42305|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.
Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
42306|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.
Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
42307|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.
Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
42308|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.
Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
42309|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.
Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
42310|NCT02144220|E1|Reported Event|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.
Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
42311|NCT02144012|B3|Baseline|Total|Total of all reporting groups
42312|NCT02144012|B2|Baseline|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42313|NCT02144012|B1|Baseline|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42314|NCT02144012|P2|Participant Flow|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42315|NCT02144012|P1|Participant Flow|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42316|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42317|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42318|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42319|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42666|NCT02141997|B1|Baseline|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
42320|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42321|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42354|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses
Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
42685|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
42322|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42323|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42324|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42325|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42326|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42327|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42328|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42329|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42330|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42331|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42332|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42333|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42334|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42335|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42336|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42337|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42338|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42339|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42340|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42341|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42342|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42343|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42344|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42345|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42346|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42347|NCT02144012|E2|Reported Event|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
42348|NCT02144012|E1|Reported Event|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
42349|NCT02143947|B3|Baseline|Total|Total of all reporting groups
42350|NCT02143947|B2|Baseline|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses
Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
42351|NCT02143947|B1|Baseline|Full Contact Orthosis|"Full Contact Orthosis
Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
42352|NCT02143947|P2|Participant Flow|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses
Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
42353|NCT02143947|P1|Participant Flow|Full Contact Orthosis|"Full Contact Orthosis
Full Contact Orthosis: The full contact in-shoe orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
42523|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
81065|NCT01895946|O2|Outcome|Part B|Part B of the study
42355|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis
Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
42356|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses
Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
42357|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis
Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
42358|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses
Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
42359|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis
Full Contact Orthosis: The full contact in-shoe orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
42360|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses
Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
42361|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis
Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
42362|NCT02143947|E2|Reported Event|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses
Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
42363|NCT02143947|E1|Reported Event|Full Contact Orthosis|"Full Contact Orthosis
Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
42364|NCT02143583|B4|Baseline|Total|Total of all reporting groups
42365|NCT02143583|B3|Baseline|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
42366|NCT02143583|B2|Baseline|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
42367|NCT02143583|B1|Baseline|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
42368|NCT02143583|P3|Participant Flow|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
42369|NCT02143583|P2|Participant Flow|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
42370|NCT02143583|P1|Participant Flow|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
42371|NCT02143583|O3|Outcome|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
42372|NCT02143583|O2|Outcome|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
42373|NCT02143583|O1|Outcome|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
42374|NCT02143583|O3|Outcome|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
42375|NCT02143583|O2|Outcome|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
42376|NCT02143583|O1|Outcome|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
42377|NCT02143583|E3|Reported Event|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
42378|NCT02143583|E2|Reported Event|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
42379|NCT02143583|E1|Reported Event|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
42380|NCT02142738|B3|Baseline|Total|Total of all reporting groups
42381|NCT02142738|B2|Baseline|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
42382|NCT02142738|B1|Baseline|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
42383|NCT02142738|P2|Participant Flow|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
42384|NCT02142738|P1|Participant Flow|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.
42385|NCT02142738|O2|Outcome|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
42386|NCT02142738|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
42387|NCT02142738|O2|Outcome|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
42388|NCT02142738|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
42389|NCT02142738|O2|Outcome|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
42390|NCT02142738|O1|Outcome|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
42391|NCT02142738|E2|Reported Event|SOC Chemotherapy|Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
42392|NCT02142738|E1|Reported Event|Pembrolizumab|Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
42393|NCT02142712|B4|Baseline|Total|Total of all reporting groups
42394|NCT02142712|B3|Baseline|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
42395|NCT02142712|B2|Baseline|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
42396|NCT02142712|B1|Baseline|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
42397|NCT02142712|P4|Participant Flow|Dextromethorphan|Dextromethorphan- 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) + current standard of care
42398|NCT02142712|P3|Participant Flow|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
42399|NCT02142712|P2|Participant Flow|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
42400|NCT02142712|P1|Participant Flow|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
42401|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
42402|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
42403|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
42404|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
42405|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
42406|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
42407|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
42408|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.
42409|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
42410|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
42411|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.
42412|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
42413|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
42414|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
42415|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
42416|NCT02142712|E3|Reported Event|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
42417|NCT02142712|E2|Reported Event|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
42418|NCT02142712|E1|Reported Event|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
42419|NCT02142504|B4|Baseline|Total|Total of all reporting groups
42516|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
74107|NCT01937130|B1|Baseline|IDN-6556 5 mg|"Dosed twice daily
IDN-6556"
42420|NCT02142504|B3|Baseline|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42421|NCT02142504|B2|Baseline|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42524|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42525|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42422|NCT02142504|B1|Baseline|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42423|NCT02142504|P3|Participant Flow|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42424|NCT02142504|P2|Participant Flow|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42425|NCT02142504|P1|Participant Flow|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42426|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42427|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42428|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42429|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42430|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42431|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42432|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42433|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42434|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42435|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42436|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42437|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42511|NCT02142361|P3|Participant Flow|Methafilcon B/Enfilcon A|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42438|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42439|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42440|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42441|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42442|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42443|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42444|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42445|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42446|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42447|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42448|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42449|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42450|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42451|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42452|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42453|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42454|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42455|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42512|NCT02142361|P2|Participant Flow|Ocufilcon D/Enfilcon A|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42456|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42457|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42458|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42459|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42460|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42461|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42462|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42463|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42464|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42465|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42466|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42467|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42468|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42469|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42470|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42471|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42472|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42473|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42513|NCT02142361|P1|Participant Flow|Omafilcon A/Enfilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42474|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42475|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42476|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42477|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42478|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42479|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42480|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42481|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42482|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42483|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42484|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42485|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42486|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42487|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42488|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42489|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42490|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42491|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42514|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42515|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42492|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42493|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42494|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42495|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42496|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42497|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42498|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42499|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42500|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42501|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42502|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42503|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42504|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42505|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42506|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42507|NCT02142504|E3|Reported Event|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
42508|NCT02142504|E2|Reported Event|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
42509|NCT02142504|E1|Reported Event|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
42510|NCT02142361|B1|Baseline|Overall Study Group|All participants were habitual wearers of hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B), and refitted with silicone hydrogel toric lens (enfilcon A)
42517|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42518|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42519|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42520|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42521|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42522|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
81066|NCT01895946|O1|Outcome|Part A|Part A of the study
42534|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42535|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42536|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42537|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42538|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42539|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42540|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42541|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42542|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42543|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42544|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42545|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42546|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42547|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42548|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42549|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42550|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42551|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42552|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42553|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42554|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42555|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42556|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42557|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
42558|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
42559|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at 1 week.
42560|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42561|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42562|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42563|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42564|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42565|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42566|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42567|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42568|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42569|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42570|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42571|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42572|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42573|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42574|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42575|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42576|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42686|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
42577|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42578|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42579|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42580|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42581|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42582|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42583|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42584|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42585|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42586|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42587|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42588|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42589|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42590|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42591|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42592|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42593|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42594|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42595|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42596|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42597|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42598|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42599|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42600|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42601|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42602|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42603|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42604|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42605|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42606|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42607|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
42637|NCT02142153|O5|Outcome|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.
No clinically significant findings"
42638|NCT02142153|O4|Outcome|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
42608|NCT02142361|E3|Reported Event|Methafilcon B|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.
enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
42609|NCT02142361|E2|Reported Event|Ocufilcon D|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.
enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
42610|NCT02142361|E1|Reported Event|Omafilcon A|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.
enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
42611|NCT02142153|B11|Baseline|Total|Total of all reporting groups
42612|NCT02142153|B10|Baseline|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42613|NCT02142153|B9|Baseline|F901318 4 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42614|NCT02142153|B8|Baseline|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42615|NCT02142153|B7|Baseline|F901318 3 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42616|NCT02142153|B6|Baseline|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42617|NCT02142153|B5|Baseline|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42618|NCT02142153|B4|Baseline|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42619|NCT02142153|B3|Baseline|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42620|NCT02142153|B2|Baseline|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42621|NCT02142153|B1|Baseline|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42622|NCT02142153|P10|Participant Flow|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42623|NCT02142153|P9|Participant Flow|F901318 4 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42624|NCT02142153|P8|Participant Flow|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42625|NCT02142153|P7|Participant Flow|F901318 3 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42626|NCT02142153|P6|Participant Flow|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42627|NCT02142153|P5|Participant Flow|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42628|NCT02142153|P4|Participant Flow|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42629|NCT02142153|P3|Participant Flow|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42664|NCT02141997|B3|Baseline|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
42630|NCT02142153|P2|Participant Flow|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42631|NCT02142153|P1|Participant Flow|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42632|NCT02142153|O10|Outcome|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
42633|NCT02142153|O9|Outcome|F901318 4 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.
No clinically significant findings"
42634|NCT02142153|O8|Outcome|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
42635|NCT02142153|O7|Outcome|F901318 3 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.
No clinically significant findings"
42636|NCT02142153|O6|Outcome|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
42639|NCT02142153|O3|Outcome|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.
No clinically significant findings"
42640|NCT02142153|O2|Outcome|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours
Placebo: Comparison of clinically significant safety lab and ECG abnormalities No clinically significant findings"
42641|NCT02142153|O1|Outcome|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.
No clinically significant findings"
42642|NCT02142153|O10|Outcome|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42643|NCT02142153|O9|Outcome|F901318 4 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42644|NCT02142153|O8|Outcome|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42645|NCT02142153|O7|Outcome|F901318 3 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42646|NCT02142153|O6|Outcome|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42647|NCT02142153|O5|Outcome|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42648|NCT02142153|O4|Outcome|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42649|NCT02142153|O3|Outcome|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42650|NCT02142153|O2|Outcome|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42651|NCT02142153|O1|Outcome|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42652|NCT02142153|E10|Reported Event|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42653|NCT02142153|E9|Reported Event|F901318 4 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42654|NCT02142153|E8|Reported Event|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42655|NCT02142153|E7|Reported Event|F901318 3 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42656|NCT02142153|E6|Reported Event|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42657|NCT02142153|E5|Reported Event|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42658|NCT02142153|E4|Reported Event|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42659|NCT02142153|E3|Reported Event|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42660|NCT02142153|E2|Reported Event|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
42661|NCT02142153|E1|Reported Event|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours
F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile"
42662|NCT02141997|B5|Baseline|Total|Total of all reporting groups
42663|NCT02141997|B4|Baseline|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
42667|NCT02141997|P4|Participant Flow|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
42668|NCT02141997|P3|Participant Flow|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
42669|NCT02141997|P2|Participant Flow|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
42670|NCT02141997|P1|Participant Flow|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
42671|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
42672|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
42673|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
42674|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
42675|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
42676|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
42677|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
42678|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
42679|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
42680|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
42681|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
42682|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
42683|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
42687|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
42688|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
42689|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
42690|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
42691|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
42692|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
42693|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
42694|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
42695|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
42696|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
42697|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
42698|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
42699|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
42700|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
42701|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
42702|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
42703|NCT02141997|E4|Reported Event|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
42704|NCT02141997|E3|Reported Event|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
42705|NCT02141997|E2|Reported Event|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
42706|NCT02141997|E1|Reported Event|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
42707|NCT02141984|B1|Baseline|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
42708|NCT02141984|P1|Participant Flow|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
42709|NCT02141984|O1|Outcome|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
42710|NCT02141984|O1|Outcome|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
42711|NCT02141984|O1|Outcome|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
42712|NCT02141984|O1|Outcome|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
42713|NCT02141984|E1|Reported Event|Patients With Polyarticular JIA or ERA|Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)
42714|NCT02141867|B1|Baseline|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery. Age 43.5 (SD 17.6) years, Male 1994 (50.8%)
42715|NCT02141867|P1|Participant Flow|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
42716|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
42717|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
42718|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
42719|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
42720|NCT02141867|E1|Reported Event|Non Cardiac Surgery|Non cardiac surgery patients 16 years or older
42721|NCT02141854|B6|Baseline|Total|Total of all reporting groups
42839|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42840|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42722|NCT02141854|B5|Baseline|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42723|NCT02141854|B4|Baseline|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42724|NCT02141854|B3|Baseline|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42725|NCT02141854|B2|Baseline|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42726|NCT02141854|B1|Baseline|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
81067|NCT01895946|O2|Outcome|Part B|Part B of the study
42727|NCT02141854|P6|Participant Flow|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42728|NCT02141854|P5|Participant Flow|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42729|NCT02141854|P4|Participant Flow|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42730|NCT02141854|P3|Participant Flow|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42731|NCT02141854|P2|Participant Flow|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42732|NCT02141854|P1|Participant Flow|Fluticasone Propionate 50 mcg BID|All enrolled participants used single-blind fluticasone propionate multidose dry powder inhaler twice a day for a total daily dose of 100 mcg during the Run-In Period (14-21 days).
42733|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42734|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42735|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42736|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42737|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42841|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42738|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42739|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42740|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42741|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42742|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42743|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42744|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42745|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42746|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42747|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42748|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42749|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42750|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42751|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42752|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42753|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
74108|NCT01937130|P4|Participant Flow|Placebo|"Dosed twice daily
Placebo"
42754|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42755|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42756|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42757|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42758|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42759|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42760|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42761|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42762|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42763|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42764|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42765|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42766|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42767|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42768|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42769|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42770|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42771|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42772|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42773|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42774|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42775|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42776|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42777|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42778|NCT02141854|E5|Reported Event|Placebo|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42779|NCT02141854|E4|Reported Event|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42780|NCT02141854|E3|Reported Event|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42781|NCT02141854|E2|Reported Event|FS MDPI 200/12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42782|NCT02141854|E1|Reported Event|FS MDPI 100/12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
42783|NCT02141633|B3|Baseline|Total|Total of all reporting groups
42784|NCT02141633|B2|Baseline|Non-smokers|"echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
42785|NCT02141633|B1|Baseline|Smokers|"echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
42786|NCT02141633|P2|Participant Flow|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol
echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
42842|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42843|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42844|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42787|NCT02141633|P1|Participant Flow|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.
echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
42788|NCT02141633|O2|Outcome|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol
echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
42789|NCT02141633|O1|Outcome|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.
echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
42790|NCT02141633|O2|Outcome|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol
echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
42791|NCT02141633|O1|Outcome|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.
echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
42792|NCT02141633|E2|Reported Event|Non-smokers|No AE or SAE had occurred
42793|NCT02141633|E1|Reported Event|Smokers|No AE or SAE had occurred
42794|NCT02141620|B1|Baseline|All Study Participants|All subjects who completed the study.
42860|NCT02141581|O3|Outcome|Group C Flumist®|Participants in this group will be randomized to Flumist® administered intranasally.
42795|NCT02141620|P2|Participant Flow|n-Acetylcysteine Then Placebo|Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
42796|NCT02141620|P1|Participant Flow|Placebo Then n-Acetylcysteine|Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.
42797|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42798|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42799|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42800|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42801|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42802|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42803|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42804|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42805|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42806|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42807|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42808|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42809|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42810|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42811|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42812|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42813|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42814|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42815|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42816|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42817|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42818|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42819|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42820|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42821|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42822|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42823|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42824|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42825|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42826|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42827|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42828|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42829|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42830|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42831|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42832|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42833|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42834|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42835|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42836|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42837|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42838|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42845|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42846|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42847|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42848|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42849|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
42850|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
42851|NCT02141620|E2|Reported Event|n-Acetylcysteine Then Placebo|Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
42852|NCT02141620|E1|Reported Event|Placebo Then n-Acetylcysteine|Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.
42853|NCT02141581|B4|Baseline|Total|Total of all reporting groups
42854|NCT02141581|B3|Baseline|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
42855|NCT02141581|B2|Baseline|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
42856|NCT02141581|B1|Baseline|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
42857|NCT02141581|P3|Participant Flow|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
42858|NCT02141581|P2|Participant Flow|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
42859|NCT02141581|P1|Participant Flow|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
42861|NCT02141581|O2|Outcome|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
42862|NCT02141581|O1|Outcome|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
42863|NCT02141581|O3|Outcome|Group C Flumist®|Participants in this group will be randomized to Flumist® administered intranasally.
42864|NCT02141581|O2|Outcome|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
42865|NCT02141581|O1|Outcome|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
42866|NCT02141581|E3|Reported Event|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
42867|NCT02141581|E2|Reported Event|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
42868|NCT02141581|E1|Reported Event|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
42869|NCT02141516|B4|Baseline|Total|Total of all reporting groups
42870|NCT02141516|B3|Baseline|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42871|NCT02141516|B2|Baseline|Asplenia|Subjects aged ≥ 2 to ≤17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42872|NCT02141516|B1|Baseline|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42873|NCT02141516|P3|Participant Flow|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42874|NCT02141516|P2|Participant Flow|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42875|NCT02141516|P1|Participant Flow|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42876|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42877|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42878|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42879|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42880|NCT02141516|O5|Outcome|Total|Total of subjects
42881|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42882|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42883|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42884|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42885|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42886|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42887|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42888|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42889|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42890|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42891|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42892|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42893|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42894|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42895|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42896|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42897|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42898|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42899|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42900|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42901|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42902|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42903|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42904|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42905|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42906|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42907|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42908|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42909|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42910|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42911|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42912|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42913|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42914|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42915|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42916|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42917|NCT02141516|E5|Reported Event|Total|Total number of Subjects
42918|NCT02141516|E4|Reported Event|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
42919|NCT02141516|E3|Reported Event|CompDef + Asplenia|Subjects aged ≥ 2 to ≤17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42920|NCT02141516|E2|Reported Event|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
42921|NCT02141516|E1|Reported Event|CompDef|Subjects aged ≥ 2 to ≤17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
42922|NCT02141360|B3|Baseline|Total|Total of all reporting groups
42923|NCT02141360|B2|Baseline|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
42924|NCT02141360|B1|Baseline|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
42925|NCT02141360|P3|Participant Flow|Volunteer Controls|"Non injured volunteers for device calibration
Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
42926|NCT02141360|P2|Participant Flow|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
42927|NCT02141360|P1|Participant Flow|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Traumatic Brain Injury (mTBI)
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
42928|NCT02141360|O3|Outcome|Volunteer Controls|"Non injured volunteers for device calibration
Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
43170|NCT02139982|P5|Participant Flow|Group A(Phase 2)|"30ml ropivacaine 0.125%
ropivacaine: Different concentration of ropivacaine"
42929|NCT02141360|O2|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
42930|NCT02141360|O1|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Traumatic Brain Injury (mTBI)
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
42931|NCT02141360|E3|Reported Event|Volunteer Controls|"Non injured volunteers for device calibration
Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
42932|NCT02141360|E2|Reported Event|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
42933|NCT02141360|E1|Reported Event|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Traumatic Brain Injury (mTBI)
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences"
42934|NCT02140164|B1|Baseline|Minocycline|"Oral administration of minocycline
Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
42935|NCT02140164|P1|Participant Flow|Minocycline|"Oral administration of minocycline
Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
42936|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline
Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
42937|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline
Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
42938|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline
Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
42939|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline
Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
42940|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline
Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
42941|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline
Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
42942|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline
Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
42943|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline
Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
42944|NCT02140164|E1|Reported Event|Minocycline|"Oral administration of minocycline
Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
42945|NCT02141217|B3|Baseline|Total|Total of all reporting groups
42946|NCT02141217|B2|Baseline|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42947|NCT02141217|B1|Baseline|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42948|NCT02141217|P2|Participant Flow|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42949|NCT02141217|P1|Participant Flow|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42950|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42951|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42952|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42953|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42954|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42955|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42956|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42957|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42958|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants randomized to clindamycin 150 mg.
42959|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants randomized to amoxicillin 875 mg plus clavulanic acid 125 mg.
42960|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42961|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42962|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42963|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42964|NCT02141217|E2|Reported Event|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42965|NCT02141217|E1|Reported Event|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
42966|NCT02140957|B3|Baseline|Total|Total of all reporting groups
42993|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.
Metformin
Fish Oil"
43139|NCT02140060|P2|Participant Flow|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
42967|NCT02140957|B2|Baseline|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
42968|NCT02140957|B1|Baseline|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
42969|NCT02140957|P2|Participant Flow|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
42970|NCT02140957|P1|Participant Flow|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
42971|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
42972|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
43013|NCT02140645|B2|Baseline|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
42973|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
42974|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
43181|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%
ropivacaine: Different concentration of ropivacaine"
42975|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
42976|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
42977|NCT02140957|E2|Reported Event|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
42978|NCT02140957|E1|Reported Event|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.
Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
42979|NCT02140788|B1|Baseline|All Subjects Who Consented|All subjects who signed a consent form
42980|NCT02140788|P4|Participant Flow|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
42981|NCT02140788|P3|Participant Flow|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.
Metformin
Fish Oil"
42982|NCT02140788|P2|Participant Flow|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.
Fish Oil"
42983|NCT02140788|P1|Participant Flow|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.
Metformin"
42984|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
42985|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.
Metformin
Fish Oil"
42986|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.
Fish Oil"
42987|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.
Metformin"
42988|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
42989|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.
Metformin
Fish Oil"
42990|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.
Fish Oil"
42991|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.
Metformin"
42992|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
42994|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.
Fish Oil"
42995|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.
Metformin"
42996|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
42997|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.
Metformin
Fish Oil"
42998|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.
Fish Oil"
42999|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.
Metformin"
43000|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
43001|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.
Metformin
Fish Oil"
43002|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.
Fish Oil"
43003|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.
Metformin"
43004|NCT02140788|E4|Reported Event|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
43005|NCT02140788|E3|Reported Event|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.
Metformin
Fish Oil"
43006|NCT02140788|E2|Reported Event|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.
Fish Oil"
43007|NCT02140788|E1|Reported Event|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.
Metformin"
43008|NCT02140645|B7|Baseline|Total|Total of all reporting groups
43009|NCT02140645|B6|Baseline|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43010|NCT02140645|B5|Baseline|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43011|NCT02140645|B4|Baseline|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43012|NCT02140645|B3|Baseline|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43014|NCT02140645|B1|Baseline|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43015|NCT02140645|P6|Participant Flow|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43016|NCT02140645|P5|Participant Flow|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43017|NCT02140645|P4|Participant Flow|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43018|NCT02140645|P3|Participant Flow|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43019|NCT02140645|P2|Participant Flow|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43020|NCT02140645|P1|Participant Flow|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43021|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43022|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43023|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43024|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43025|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43026|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43027|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43028|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43029|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43030|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43031|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43032|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43033|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43034|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43035|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43036|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43037|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43038|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43039|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43040|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43041|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43042|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43043|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43166|NCT02139982|P9|Participant Flow|Group E(Phase 2)|"30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine"
43044|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43045|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43046|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43047|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43048|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43049|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43050|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43051|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43052|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43053|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43054|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43055|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43056|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43057|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43058|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43059|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43060|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43061|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43062|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43063|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43064|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43065|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43066|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43067|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43068|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43069|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43070|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43071|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43072|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43073|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43167|NCT02139982|P8|Participant Flow|Group D(Phase 2)|"30ml ropivacaine 0.375%
ropivacaine: Different concentration of ropivacaine"
43074|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43075|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43076|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43077|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43078|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43079|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43080|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43081|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43082|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43083|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43084|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43085|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43086|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43087|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43088|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43089|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43090|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43091|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43092|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43093|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43094|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43095|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43096|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43097|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43098|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43099|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
43100|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
43101|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
43102|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
43103|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43168|NCT02139982|P7|Participant Flow|Group C(Phase 2)|"30ml ropivacaine 0.25%
ropivacaine: Different concentration of ropivacaine"
43104|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
43105|NCT02140645|E1|Reported Event|MarketScan|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
43106|NCT02140593|B3|Baseline|Total|Total of all reporting groups
43107|NCT02140593|B2|Baseline|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
43108|NCT02140593|B1|Baseline|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).
Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
43109|NCT02140593|P2|Participant Flow|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
43138|NCT02140060|P3|Participant Flow|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43110|NCT02140593|P1|Participant Flow|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).
Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
43111|NCT02140593|O2|Outcome|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
43112|NCT02140593|O1|Outcome|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).
Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
43113|NCT02140593|O2|Outcome|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
43114|NCT02140593|O1|Outcome|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).
Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
43115|NCT02140593|E2|Reported Event|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
43116|NCT02140593|E1|Reported Event|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).
Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
43117|NCT02140372|B1|Baseline|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
43118|NCT02140372|P1|Participant Flow|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
43119|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
43120|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
43121|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
43122|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
43123|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
43124|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
43125|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
43126|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
43127|NCT02140372|E1|Reported Event|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
43128|NCT02140060|B7|Baseline|Total|Total of all reporting groups
43129|NCT02140060|B6|Baseline|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43130|NCT02140060|B5|Baseline|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
43169|NCT02139982|P6|Participant Flow|Group B(Phase 2)|"30ml ropivacaine 0.2%
ropivacaine: Different concentration of ropivacaine"
43131|NCT02140060|B4|Baseline|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43132|NCT02140060|B3|Baseline|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43133|NCT02140060|B2|Baseline|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43134|NCT02140060|B1|Baseline|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43135|NCT02140060|P6|Participant Flow|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43136|NCT02140060|P5|Participant Flow|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
43137|NCT02140060|P4|Participant Flow|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43140|NCT02140060|P1|Participant Flow|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43141|NCT02140060|O6|Outcome|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43142|NCT02140060|O5|Outcome|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
43143|NCT02140060|O4|Outcome|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43144|NCT02140060|O3|Outcome|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43145|NCT02140060|O2|Outcome|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43146|NCT02140060|O1|Outcome|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43147|NCT02140060|E7|Reported Event|Pre-treatment|All subjects who signed an informed consent to participate in the study
43148|NCT02140060|E6|Reported Event|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43149|NCT02140060|E5|Reported Event|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
43150|NCT02140060|E4|Reported Event|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43151|NCT02140060|E3|Reported Event|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43152|NCT02140060|E2|Reported Event|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43153|NCT02140060|E1|Reported Event|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
43154|NCT02139982|B11|Baseline|Total|Total of all reporting groups
43155|NCT02139982|B10|Baseline|Group F(Phase 2)|"30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine"
43156|NCT02139982|B9|Baseline|Group E(Phase 2)|"30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine"
43157|NCT02139982|B8|Baseline|Group D(Phase 2)|"30ml ropivacaine 0.375%
ropivacaine: Different concentration of ropivacaine"
43158|NCT02139982|B7|Baseline|Group C(Phase 2)|"30ml ropivacaine 0.25%
ropivacaine: Different concentration of ropivacaine"
43159|NCT02139982|B6|Baseline|Group B(Phase 2)|"30ml ropivacaine 0.2%
ropivacaine: Different concentration of ropivacaine"
43160|NCT02139982|B5|Baseline|Group A(Phase 2)|"30ml ropivacaine 0.125%
ropivacaine: Different concentration of ropivacaine"
43161|NCT02139982|B4|Baseline|Group ME (Phase 1)|"specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43162|NCT02139982|B3|Baseline|Group RA (Phase 1)|"specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43163|NCT02139982|B2|Baseline|Group UL( Phase 1)|"specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43164|NCT02139982|B1|Baseline|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43165|NCT02139982|P10|Participant Flow|Group F(Phase 2)|"30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine"
74123|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily
IDN-6556"
43171|NCT02139982|P4|Participant Flow|Group ME (Phase 1)|"specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43172|NCT02139982|P3|Participant Flow|Group RA (Phase 1)|"specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43173|NCT02139982|P2|Participant Flow|Group UL( Phase 1)|"specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43174|NCT02139982|P1|Participant Flow|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43175|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43176|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43177|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43178|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43179|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine"
43180|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine"
43182|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%
ropivacaine: Different concentration of ropivacaine"
43183|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%
ropivacaine: Different concentration of ropivacaine"
43184|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%
ropivacaine: Different concentration of ropivacaine"
43185|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine"
43186|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine"
43187|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%
ropivacaine: Different concentration of ropivacaine"
43188|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%
ropivacaine: Different concentration of ropivacaine"
43189|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%
ropivacaine: Different concentration of ropivacaine"
43190|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%
ropivacaine: Different concentration of ropivacaine"
43191|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43192|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43193|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43194|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43195|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine"
43196|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine"
43197|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%
ropivacaine: Different concentration of ropivacaine"
43198|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%
ropivacaine: Different concentration of ropivacaine"
43199|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%
ropivacaine: Different concentration of ropivacaine"
43200|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%
ropivacaine: Different concentration of ropivacaine"
43201|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43202|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43203|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43204|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43205|NCT02139982|E10|Reported Event|Group F(Phase 2)|"30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine"
43206|NCT02139982|E9|Reported Event|Group E(Phase 2)|"30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine"
43207|NCT02139982|E8|Reported Event|Group D(Phase 2)|"30ml ropivacaine 0.375%
ropivacaine: Different concentration of ropivacaine"
43208|NCT02139982|E7|Reported Event|Group C(Phase 2)|"30ml ropivacaine 0.25%
ropivacaine: Different concentration of ropivacaine"
43209|NCT02139982|E6|Reported Event|Group B(Phase 2)|"30ml ropivacaine 0.2%
ropivacaine: Different concentration of ropivacaine"
43210|NCT02139982|E5|Reported Event|Group A(Phase 2)|"30ml ropivacaine 0.125%
ropivacaine: Different concentration of ropivacaine"
43211|NCT02139982|E4|Reported Event|Group ME (Phase 1)|"specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43212|NCT02139982|E3|Reported Event|Group RA (Phase 1)|"specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43213|NCT02139982|E2|Reported Event|Group UL( Phase 1)|"specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43214|NCT02139982|E1|Reported Event|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
43215|NCT02139943|B4|Baseline|Total|Total of all reporting groups
43216|NCT02139943|B3|Baseline|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
43217|NCT02139943|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
43218|NCT02139943|B1|Baseline|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
43219|NCT02139943|P3|Participant Flow|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
43220|NCT02139943|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
43221|NCT02139943|P1|Participant Flow|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
43222|NCT02139943|O3|Outcome|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
43223|NCT02139943|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
43224|NCT02139943|O1|Outcome|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
43225|NCT02139943|O3|Outcome|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
43226|NCT02139943|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
81068|NCT01895946|O1|Outcome|Part A|Part A of the study
43227|NCT02139943|O1|Outcome|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
43228|NCT02139943|E3|Reported Event|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
43229|NCT02139943|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
43230|NCT02139943|E1|Reported Event|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
43231|NCT02139878|B1|Baseline|Entire Study Population|Includes groups randomized to receive Wild Blueberry Juice first and Placebo first
43232|NCT02139878|P2|Participant Flow|Placebo First, Then Wild Blueberry Juice|240 ml Placebo beverage daily in first intervention period and 240 ml Wild Blueberry Juice daily in second intervention period (after washout period).
43233|NCT02139878|P1|Participant Flow|Wild Blueberry Juice First, Then Placebo|240 ml Wild Blueberry Juice daily first in intervention period and 240 ml Placebo beverage daily in second intervention period (after washout period)
43234|NCT02139878|O2|Outcome|Placebo|240 ml placebo beverage
43235|NCT02139878|O1|Outcome|Wild Blueberry Juice|240 ml wild blueberry juice
43236|NCT02139878|O2|Outcome|Placebo|240 ml placebo beverage
43237|NCT02139878|O1|Outcome|Wild Blueberry Juice|240 ml wild blueberry juice
43238|NCT02139878|E2|Reported Event|Placebo|240 ml Placebo beverage daily in either the first intervention period or second intervention period
43239|NCT02139878|E1|Reported Event|Wild Blueberry Juice|240 ml Wild Blueberry Juice daily in either first intervention period or second intervention period
43240|NCT02139644|B6|Baseline|Total|Total of all reporting groups
43241|NCT02139644|B5|Baseline|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43242|NCT02139644|B4|Baseline|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43243|NCT02139644|B3|Baseline|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43244|NCT02139644|B2|Baseline|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43245|NCT02139644|B1|Baseline|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43246|NCT02139644|P6|Participant Flow|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43247|NCT02139644|P5|Participant Flow|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43248|NCT02139644|P4|Participant Flow|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43249|NCT02139644|P3|Participant Flow|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43250|NCT02139644|P2|Participant Flow|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43251|NCT02139644|P1|Participant Flow|Enrolled Patients|During the run-in period (from the screening visit to the randomization visit), all patients replaced their current rescue medication with study-specific rescue medication (albuterol/salbutamol HFA MDI) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the period. All patients discontinued their current ICS or ICS/LABA, and took 1 inhalation twice a day from a single-blinded placebo MDPI device and 1 puff twice a day from open-label QVAR 40 mcg HFA MDI (or equivalent).
43252|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43332|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task
Computerized Cognitive Training - active: Cognitive training using working memory span task"
43253|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43254|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43255|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43256|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43257|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43258|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43259|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43260|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43261|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43262|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43263|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43264|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43265|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43284|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43266|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43267|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43268|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43269|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43333|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task
Computerized cognitive training - sham: Sham training condition"
43270|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43271|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43272|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43273|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43274|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43275|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43276|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43277|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43278|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43279|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43280|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43281|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43282|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43283|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43474|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43285|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43286|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43287|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43334|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task
Computerized Cognitive Training - active: Cognitive training using working memory span task"
43288|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43289|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43290|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43291|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43292|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43293|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43294|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43295|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43296|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43297|NCT02139644|E5|Reported Event|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43298|NCT02139644|E4|Reported Event|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43299|NCT02139644|E3|Reported Event|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43300|NCT02139644|E2|Reported Event|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43301|NCT02139644|E1|Reported Event|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
43302|NCT02139228|B3|Baseline|Total|Total of all reporting groups
43303|NCT02139228|B2|Baseline|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial"
43304|NCT02139228|B1|Baseline|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial"
43305|NCT02139228|P2|Participant Flow|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial"
43306|NCT02139228|P1|Participant Flow|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial"
43374|NCT02139007|B3|Baseline|Total|Total of all reporting groups
43375|NCT02139007|B2|Baseline|Discontinuation Arm|Alendronate discontinuation arm
43307|NCT02139228|O2|Outcome|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial"
43308|NCT02139228|O1|Outcome|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial"
43309|NCT02139228|O2|Outcome|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial"
43310|NCT02139228|O1|Outcome|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial"
43311|NCT02139228|E2|Reported Event|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial"
43312|NCT02139228|E1|Reported Event|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial"
43313|NCT02139176|B3|Baseline|Total|Total of all reporting groups
43314|NCT02139176|B2|Baseline|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
patient referral: A patient agrees to recruit their partner using the invitation."
43315|NCT02139176|B1|Baseline|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
patient referral: A patient agrees to recruit their partner using the invitation."
43316|NCT02139176|P2|Participant Flow|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
patient referral: A patient agrees to recruit their partner using the invitation."
43317|NCT02139176|P1|Participant Flow|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
patient referral: A patient agrees to recruit their partner using the invitation."
43318|NCT02139176|O2|Outcome|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community."
43319|NCT02139176|O1|Outcome|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
patient referral: A patient agrees to recruit their partner using the invitation."
43320|NCT02139176|O2|Outcome|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
Contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community."
43321|NCT02139176|O1|Outcome|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
patient referral: A patient agrees to recruit their partner using the invitation."
43322|NCT02139176|O2|Outcome|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community."
43323|NCT02139176|O1|Outcome|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
patient referral: A patient agrees to recruit their partner using the invitation."
43324|NCT02139176|E2|Reported Event|Contract Referral|"Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community."
43325|NCT02139176|E1|Reported Event|Patient Referral|"Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
patient referral: A patient agrees to recruit their partner using the invitation."
43326|NCT02139137|B3|Baseline|Total|Total of all reporting groups
43327|NCT02139137|B2|Baseline|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task
Computerized cognitive training - sham: Sham training condition"
43328|NCT02139137|B1|Baseline|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task
Computerized Cognitive Training - active: Cognitive training using working memory span task"
43329|NCT02139137|P2|Participant Flow|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task
Computerized cognitive training - sham: Sham training condition"
43330|NCT02139137|P1|Participant Flow|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task
Computerized Cognitive Training - active: Cognitive training using working memory span task"
43331|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task
Computerized cognitive training - sham: Sham training condition"
43335|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task
Computerized cognitive training - sham: Sham training condition"
43336|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task
Computerized Cognitive Training - active: Cognitive training using working memory span task"
43337|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task
Computerized cognitive training - sham: Sham training condition"
43338|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task
Computerized Cognitive Training - active: Cognitive training using working memory span task"
43339|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task
Computerized cognitive training - sham: Sham training condition"
43340|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task
Computerized Cognitive Training - active: Cognitive training using working memory span task"
43341|NCT02139137|E2|Reported Event|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task
Computerized cognitive training - sham: Sham training condition"
43342|NCT02139137|E1|Reported Event|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task
Computerized Cognitive Training - active: Cognitive training using working memory span task"
43343|NCT02139046|B6|Baseline|Total|Total of all reporting groups
43344|NCT02139046|B5|Baseline|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43345|NCT02139046|B4|Baseline|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43346|NCT02139046|B3|Baseline|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43347|NCT02139046|B2|Baseline|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43348|NCT02139046|B1|Baseline|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43349|NCT02139046|P5|Participant Flow|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43350|NCT02139046|P4|Participant Flow|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43351|NCT02139046|P3|Participant Flow|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43352|NCT02139046|P2|Participant Flow|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43353|NCT02139046|P1|Participant Flow|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43354|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43355|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43376|NCT02139007|B1|Baseline|Continuation Arm|Alendronate continuation arm
43377|NCT02139007|P2|Participant Flow|Discontinuation Arm|"Alendronate discontinuation arm
Participants were randomized to stop taking their current alendronate prescription."
43356|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43357|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43358|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43359|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43360|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43361|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43362|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43363|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43364|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43365|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43366|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43367|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43368|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43369|NCT02139046|E5|Reported Event|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43370|NCT02139046|E4|Reported Event|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43371|NCT02139046|E3|Reported Event|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43372|NCT02139046|E2|Reported Event|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43373|NCT02139046|E1|Reported Event|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
43378|NCT02139007|P1|Participant Flow|Continuation Arm|"Alendronate continuation arm
Participants were randomized to continue their current alendronate prescription at prescribed dose."
43379|NCT02139007|O2|Outcome|Discontinuation Arm|"Alendronate discontinuation arm
Alendronate"
43380|NCT02139007|O1|Outcome|Continuation Arm|"Alendronate continuation arm
Alendronate"
43381|NCT02139007|O2|Outcome|Discontinuation Arm|"Alendronate discontinuation arm
Alendronate"
43382|NCT02139007|O1|Outcome|Continuation Arm|"Alendronate continuation arm
Alendronate"
43383|NCT02139007|O2|Outcome|Discontinuation Arm|"Alendronate discontinuation arm
Alendronate"
43384|NCT02139007|O1|Outcome|Continuation Arm|"Alendronate continuation arm
Alendronate"
43385|NCT02139007|O1|Outcome|All Study Sites-Initiation to the First Participant Recruited|study initiation to the first participant recruited
43386|NCT02139007|O1|Outcome|All Study Sites --IRB Approval|The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
43387|NCT02139007|O1|Outcome|All Study Sites -- Contracting Procedures|The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
43388|NCT02139007|E2|Reported Event|Discontinuation Arm|"Alendronate discontinuation arm
Alendronate"
43389|NCT02139007|E1|Reported Event|Continuation Arm|"Alendronate continuation arm
Alendronate"
43390|NCT02138825|B3|Baseline|Total|Total of all reporting groups
43391|NCT02138825|B2|Baseline|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
43392|NCT02138825|B1|Baseline|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
43393|NCT02138825|P2|Participant Flow|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
43394|NCT02138825|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
43475|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43476|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43477|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43395|NCT02138825|O2|Outcome|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
43396|NCT02138825|O1|Outcome|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
43397|NCT02138825|O2|Outcome|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
43442|NCT02138461|B1|Baseline|Bimatoprost|These patients take bimatoprost topically for glaucoma.
43398|NCT02138825|O1|Outcome|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
43399|NCT02138825|E2|Reported Event|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
43400|NCT02138825|E1|Reported Event|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, throughout which all participants continued the treatment with Riociguat. The long-term extension phase included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
43401|NCT02138747|B5|Baseline|Total|Total of all reporting groups
43402|NCT02138747|B4|Baseline|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
43403|NCT02138747|B3|Baseline|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43404|NCT02138747|B2|Baseline|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
43405|NCT02138747|B1|Baseline|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
43406|NCT02138747|P4|Participant Flow|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
43407|NCT02138747|P3|Participant Flow|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43408|NCT02138747|P2|Participant Flow|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
43478|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43479|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43480|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43409|NCT02138747|P1|Participant Flow|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
43410|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43411|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43412|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43413|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43414|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43443|NCT02138461|P2|Participant Flow|Latanoprost Group|These patients take latanoprost topically for glaucoma.
81069|NCT01895946|O2|Outcome|Part B|Part B of the study
43415|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43416|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43417|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43418|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43419|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43420|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43421|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43422|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43423|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43424|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43425|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43426|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43427|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43428|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43429|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43430|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43431|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43432|NCT02138747|O4|Outcome|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
43433|NCT02138747|O3|Outcome|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43434|NCT02138747|O2|Outcome|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
43435|NCT02138747|O1|Outcome|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
43436|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43437|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43438|NCT02138747|E2|Reported Event|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
43439|NCT02138747|E1|Reported Event|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
43440|NCT02138461|B3|Baseline|Total|Total of all reporting groups
43441|NCT02138461|B2|Baseline|Latanoprost Group|These patients take latanoprost topically for glaucoma.
43444|NCT02138461|P1|Participant Flow|Bimatoprost|These patients take bimatoprost topically for glaucoma.
43445|NCT02138461|O2|Outcome|Latanoprost Group|These patients take latanoprost topically for glaucoma.
43446|NCT02138461|O1|Outcome|Bimatoprost|These patients take bimatoprost topically for glaucoma.
43447|NCT02138461|E2|Reported Event|Latanoprost Group|These patients take latanoprost topically for glaucoma.
43448|NCT02138461|E1|Reported Event|Bimatoprost|These patients take bimatoprost topically for glaucoma.
43449|NCT02138097|B19|Baseline|Total|Total of all reporting groups
43450|NCT02138097|B18|Baseline|MS: GLP-I RA|Patients in the MarketScan (MS) cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43451|NCT02138097|B17|Baseline|MS: Alpha-Glucosidase Inhibitors|Patients in the MarketScan (MS) cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43452|NCT02138097|B16|Baseline|MS: Meglitinides|Patients in the MarketScan (MS) cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43453|NCT02138097|B15|Baseline|MS: Glitazones|Patients in the MarketScan (MS) cohort using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43454|NCT02138097|B14|Baseline|MS: Sulfonylurea|Patients in the MarketScan (MS) cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43455|NCT02138097|B13|Baseline|MS: Metformin|Patients in the MarketScan (MS) cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.
43456|NCT02138097|B12|Baseline|MS: Saxagliptin|Patients in the MarketScan (MS) cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43457|NCT02138097|B11|Baseline|MS: Sitagliptin|Patients in the MarketScan (MS) cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43458|NCT02138097|B10|Baseline|MS: Linagliptin|Patients in the MarketScan (MS) cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43459|NCT02138097|B9|Baseline|UHC: GLP-I RA|Patients in the United Healthcare cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43460|NCT02138097|B8|Baseline|UHC: Alpha-Glucosidase Inhibitors|Patients in the United Healthcare cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43461|NCT02138097|B7|Baseline|UHC: Sulfonylurea|Patients in the United Healthcare cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43462|NCT02138097|B6|Baseline|UHC: Sitagliptin|Patients in the United Healthcare cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43463|NCT02138097|B5|Baseline|UHC: Saxagliptin|Patients in the United Healthcare cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43464|NCT02138097|B4|Baseline|UHC: Metformin|Patients in the United Healthcare cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.
43465|NCT02138097|B3|Baseline|UHC: Meglitinides|Patients in the United Healthcare cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43466|NCT02138097|B2|Baseline|UHC: Linagliptin|Patients in the United Healthcare cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43467|NCT02138097|B1|Baseline|UHC: Glitazones|Patients in the United Healthcare cohort (UHC) using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43468|NCT02138097|P2|Participant Flow|MarketScan|Patients using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
43469|NCT02138097|P1|Participant Flow|United Healthcare|Patients using an oral and non-insulin injected glucose-lowering medication identified from the United Healthcare Research database
43470|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43471|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43472|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43473|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
44363|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
43481|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43482|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43483|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43484|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43485|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43486|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43487|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43488|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43489|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43490|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43491|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43492|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
81070|NCT01895946|O1|Outcome|Part A|Part A of the study
43493|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43494|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43495|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43496|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43497|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43498|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43499|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43500|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43501|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43502|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43503|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43504|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43505|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43506|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43507|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43508|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43509|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43510|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43511|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43512|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43513|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43514|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43515|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43516|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43517|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43518|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43519|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43520|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43521|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43522|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43523|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43524|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43525|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43526|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43527|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43528|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43529|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43530|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43531|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43532|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43533|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43534|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43535|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43536|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43537|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43538|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43954|NCT02135432|O1|Outcome|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg
Ivacaftor"
43539|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43540|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43541|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43542|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43543|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43544|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43545|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43546|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43547|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43548|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43549|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43550|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43551|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43552|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43553|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43554|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43555|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43556|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43557|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43558|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43559|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43560|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43561|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43562|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43563|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43564|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43565|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43566|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43567|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43568|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43569|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43570|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43571|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43572|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43573|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43574|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43575|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43576|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43577|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43578|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43579|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43580|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43581|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43582|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43583|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43584|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43585|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43586|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43587|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43588|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43589|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43590|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43591|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43592|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43593|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43594|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43595|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43596|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43597|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43598|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43599|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43600|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43601|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43602|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43603|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43604|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43605|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43606|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43607|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43608|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43609|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43610|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43611|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43612|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43613|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43614|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43615|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43616|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43617|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43618|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
44364|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
43619|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43620|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43621|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43622|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43623|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43624|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43625|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43626|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43627|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43628|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43629|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43955|NCT02135432|O2|Outcome|Placebo|"matching placebo
Placebo"
81071|NCT01895946|O2|Outcome|Part B|Part B of the study
43630|NCT02138097|O9|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43631|NCT02138097|O8|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43632|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43633|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43634|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43635|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43636|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43637|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43638|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43639|NCT02138097|O9|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43640|NCT02138097|O8|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43641|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43642|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43643|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43644|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43645|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43646|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43647|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43648|NCT02138097|E10|Reported Event|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
43649|NCT02138097|E9|Reported Event|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
43650|NCT02138097|E8|Reported Event|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
43651|NCT02138097|E7|Reported Event|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
43652|NCT02138097|E6|Reported Event|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
43653|NCT02138097|E5|Reported Event|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
43654|NCT02138097|E4|Reported Event|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
43655|NCT02138097|E3|Reported Event|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
43656|NCT02138097|E2|Reported Event|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
43657|NCT02138097|E1|Reported Event|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
43658|NCT02138006|B3|Baseline|Total|Total of all reporting groups
43659|NCT02138006|B2|Baseline|Standard Insulin Treatment|"Standard insulin treatment
Standard insulin treatment"
43660|NCT02138006|B1|Baseline|Intensive Insulin Treatment|"Intensive insulin treatment
Intensive insulin treatment"
43661|NCT02138006|P2|Participant Flow|Standard Insulin Treatment|"Standard insulin treatment
Standard insulin treatment"
43662|NCT02138006|P1|Participant Flow|Intensive Insulin Treatment|"Intensive insulin treatment
Intensive insulin treatment"
43663|NCT02138006|O2|Outcome|Standard Insulin Treatment|"Standard insulin treatment
Standard insulin treatment"
43664|NCT02138006|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment
Intensive insulin treatment"
43665|NCT02138006|O2|Outcome|Standard Insulin Treatment|"Standard insulin treatment
Standard insulin treatment"
43666|NCT02138006|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment
Intensive insulin treatment"
43667|NCT02138006|E2|Reported Event|Standard Insulin Treatment|"Standard insulin treatment
Standard insulin treatment"
43668|NCT02138006|E1|Reported Event|Intensive Insulin Treatment|"Intensive insulin treatment
Intensive insulin treatment"
43669|NCT02137785|B3|Baseline|Total|Total of all reporting groups
43670|NCT02137785|B2|Baseline|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43671|NCT02137785|B1|Baseline|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43672|NCT02137785|P2|Participant Flow|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43673|NCT02137785|P1|Participant Flow|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43674|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
81072|NCT01895946|O1|Outcome|Part A|Part A of the study
43675|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43676|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43677|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43678|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43679|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43680|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43681|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43682|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43683|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43684|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43685|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43686|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43687|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43688|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43689|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43690|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43691|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43692|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43693|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43694|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43695|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43696|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43697|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43698|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43699|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43700|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43701|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43956|NCT02135432|O1|Outcome|Ivacaftor|patients randomized to ivacaftor twice daily
43702|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43703|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43704|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43705|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43706|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43707|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43708|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43709|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43710|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43711|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43712|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43713|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43714|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43715|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43716|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43717|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43718|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43719|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43720|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43721|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43722|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
44365|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
43723|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43724|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43725|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43726|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43727|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43728|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43729|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43730|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43731|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43732|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43733|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43734|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43735|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43736|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43737|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43738|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43739|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43740|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43741|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43742|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43743|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43744|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43745|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43746|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43747|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43748|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43749|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
44170|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
43750|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43751|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43752|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43753|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43754|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43755|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43756|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43757|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43758|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43759|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43760|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43761|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43762|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43763|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43764|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43765|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43766|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43767|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43768|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43769|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43770|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43771|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43772|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43773|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43774|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43775|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43776|NCT02137785|E2|Reported Event|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
44366|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
43777|NCT02137785|E1|Reported Event|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
43778|NCT02137603|B3|Baseline|Total|Total of all reporting groups
43779|NCT02137603|B2|Baseline|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
43780|NCT02137603|B1|Baseline|Fast Track|"Patients discharged home the same day following appendectomy
Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
43781|NCT02137603|P2|Participant Flow|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
43782|NCT02137603|P1|Participant Flow|Fast Track|"Patients discharged home the same day following appendectomy
Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
43783|NCT02137603|O2|Outcome|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
43957|NCT02135432|O2|Outcome|Placebo|"matching placebo
Placebo"
43784|NCT02137603|O1|Outcome|Fast Track|"Patients discharged home the same day following appendectomy
Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
43785|NCT02137603|O2|Outcome|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
43786|NCT02137603|O1|Outcome|Fast Track|"Patients discharged home the same day following appendectomy
Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
43787|NCT02137603|E2|Reported Event|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
43788|NCT02137603|E1|Reported Event|Fast Track|"Patients discharged home the same day following appendectomy
Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
43789|NCT02137512|B1|Baseline|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43790|NCT02137512|P1|Participant Flow|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43791|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43792|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43793|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43794|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43863|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43795|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43796|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
81073|NCT01895946|O2|Outcome|Part B|Part B of the study
43797|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43798|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43799|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43800|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43801|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43802|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43803|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43804|NCT02137512|E1|Reported Event|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
DiAs – a smart-phone medical platform;
Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
43805|NCT02137447|B1|Baseline|Treatment Group|Negative Pressure treatment
74124|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily
IDN-6556"
43806|NCT02137447|P1|Participant Flow|Negative Pressure Wound Therapy|"After the completion of the operation, incisional skin closure was performed using sutures or staples and the wound was then covered with the Negative Pressure Wound therapy Prevena Incision Management System (Kinetic Concepts Inc) as per the manufacturer's instructions of use. Continuous negative pressure was applied at 125 mm Hg.
For inpatients, wounds were assessed every 48 hours by inspection and palpation. The dressing was not routinely removed, but the surrounding skin was assessed for cellulitis. The NPWT dressing was removed between post-operative day 5 and 7."
43807|NCT02137447|O1|Outcome|Treatment Group|Negative Pressure Wound Therapy (NPWT) to closed surgical incision
43808|NCT02137447|O1|Outcome|Treatment Group|Negative Pressure Wound Therapy (NPWT) to closed surgical incision
43809|NCT02137447|E1|Reported Event|Treatment Group|Negative Pressure Wound Therapy (NPWT) to closed surgical incision
43810|NCT02137382|B1|Baseline|Sequence Creon N/Creon® or Creon®/Creon N|Participants who were randomized to receive either Creon N or Creon.
43841|NCT02136238|B2|Baseline|Experimental Group: Unilateral TR or Wrist-disartic Amputees|Includes groups randomized to receive either TRS Grip 3 voluntary close device or Hosmer 5XA voluntary open device first.
43811|NCT02137382|P2|Participant Flow|Sequence: Creon®/Creon N|Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
43812|NCT02137382|P1|Participant Flow|Sequence: Creon N/Creon®|Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
43813|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
43814|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
43815|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
43816|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
43817|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
43818|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
43819|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
43820|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
43821|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
43822|NCT02137382|O1|Outcome|Creon®|Creon® : active comparator
43823|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
43824|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
43825|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
43826|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
43827|NCT02137382|E2|Reported Event|Creon N|Creon N: experimental drug
43828|NCT02137382|E1|Reported Event|Creon®|Creon®: active comparator
43829|NCT02136498|B3|Baseline|Total|Total of all reporting groups
43830|NCT02136498|B2|Baseline|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.
The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
43831|NCT02136498|B1|Baseline|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.
Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
43832|NCT02136498|P2|Participant Flow|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.
The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
43833|NCT02136498|P1|Participant Flow|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.
Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
43834|NCT02136498|O2|Outcome|Augmented mHealth Self-help + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.
The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
43835|NCT02136498|O1|Outcome|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.
Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
43836|NCT02136498|O2|Outcome|Augmented mHealth Self-help + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.
The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
43837|NCT02136498|O1|Outcome|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.
Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
43886|NCT02136004|E1|Reported Event|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
43838|NCT02136498|E2|Reported Event|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.
The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
43839|NCT02136498|E1|Reported Event|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.
Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
43840|NCT02136238|B3|Baseline|Total|Total of all reporting groups
43842|NCT02136238|B1|Baseline|Non-amputee Control Group|non-amputee healthy controls
43843|NCT02136238|P3|Participant Flow|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
No intervention. Control group.: There are no interventions in this observational arm of the study."
43844|NCT02136238|P2|Participant Flow|Voluntary Close Device First Then Voluntary Open Device|Voluntary close device (TRS Grip 3 terminal device) first then voluntary open device (Hosmer 5X hook terminal device)
43845|NCT02136238|P1|Participant Flow|Voluntary Open Device First Then Voluntary Close Device|Voluntary open device (Hosmer 5X hook terminal device) first then voluntary close device (TRS Grip 3 terminal device)
43846|NCT02136238|O3|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
No intervention. Control group.: There are no interventions in this observational arm of the study."
43847|NCT02136238|O2|Outcome|Voluntary Close (TRS Grip 3)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
43848|NCT02136238|O1|Outcome|Voluntary Open (Hosmer 5XA)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
43849|NCT02136238|O3|Outcome|Non-amputee Controls|This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
43850|NCT02136238|O2|Outcome|Prosthetic Hand 2 (TRS Grip 3)|"This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
TRS Grip 3 voluntary closing hook: Voluntary closing prosthetic terminal device (hand)"
43851|NCT02136238|O1|Outcome|Prosthetic Hand 1 (Hosmer 5XA)|"This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
Hosmer 5XA voluntary opening hook: Voluntary opening prosthetic terminal device (hand)"
43852|NCT02136238|E3|Reported Event|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
No intervention. Control group.: There are no interventions in this observational arm of the study."
43853|NCT02136238|E2|Reported Event|Voluntary Close (TRS Grip 3)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
43854|NCT02136238|E1|Reported Event|Voluntary Open (Hosmer 5XA)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
43855|NCT02136134|B3|Baseline|Total|Total of all reporting groups
43856|NCT02136134|B2|Baseline|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43857|NCT02136134|B1|Baseline|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43858|NCT02136134|P2|Participant Flow|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43859|NCT02136134|P1|Participant Flow|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43860|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43861|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43862|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
44079|NCT02133781|B2|Baseline|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
43864|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43865|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43866|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43958|NCT02135432|O1|Outcome|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg
Ivacaftor"
43867|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43868|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43869|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43870|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43871|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43872|NCT02136134|E2|Reported Event|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43873|NCT02136134|E1|Reported Event|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
43874|NCT02136004|B3|Baseline|Total|Total of all reporting groups
43875|NCT02136004|B2|Baseline|Closer VSS - Interventional Cohort|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in interventional endovascular cases.
Closer VSS: At the end of a percutaneous interventional endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
43876|NCT02136004|B1|Baseline|Closer VSS - Diagnostic Cohort|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in diagnostic endovascular cases.
Closer VSS: At the end of a percutaneous diagnostic endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
43877|NCT02136004|P1|Participant Flow|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
43878|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
43879|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
43880|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
43881|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
43882|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
43883|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
43884|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
43885|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
44171|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
43887|NCT02135900|B1|Baseline|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.
Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
43888|NCT02135900|P1|Participant Flow|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.
Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
43889|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.
Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
43950|NCT02135432|P1|Participant Flow|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg
Ivacaftor"
43890|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.
Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
43891|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.
Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
43892|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.
Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
43893|NCT02135900|E1|Reported Event|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.
Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
43894|NCT02135445|B3|Baseline|Total|Total of all reporting groups
43895|NCT02135445|B2|Baseline|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43896|NCT02135445|B1|Baseline|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43897|NCT02135445|P2|Participant Flow|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43898|NCT02135445|P1|Participant Flow|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43899|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43900|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43901|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43902|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43903|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43904|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43905|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43906|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43907|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43908|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43909|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43910|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43911|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43912|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43913|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
74125|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily
IDN-6556"
43914|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43915|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43916|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43917|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43951|NCT02135432|O2|Outcome|Placebo|"matching placebo
Placebo"
43918|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43919|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43920|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43921|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43922|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43923|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43924|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43925|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43926|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43927|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43928|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43929|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43930|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43931|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43932|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43933|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43934|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43935|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43936|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43937|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43938|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43939|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43940|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43941|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43942|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43943|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
74126|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily
IDN-6556"
43944|NCT02135445|E2|Reported Event|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
43945|NCT02135445|E1|Reported Event|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
43946|NCT02135432|B3|Baseline|Total|Total of all reporting groups
43947|NCT02135432|B2|Baseline|Placebo|"matching placebo
Placebo"
43948|NCT02135432|B1|Baseline|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg
Ivacaftor"
43949|NCT02135432|P2|Participant Flow|Placebo|"matching placebo
Placebo"
43952|NCT02135432|O1|Outcome|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg
Ivacaftor"
43960|NCT02135432|E1|Reported Event|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg
Ivacaftor"
43961|NCT02135016|B4|Baseline|Total|Total of all reporting groups
43962|NCT02135016|B3|Baseline|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
43963|NCT02135016|B2|Baseline|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
43964|NCT02135016|B1|Baseline|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
43965|NCT02135016|P3|Participant Flow|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
43966|NCT02135016|P2|Participant Flow|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
43967|NCT02135016|P1|Participant Flow|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
43968|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
43969|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
43970|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
43971|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
43972|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
43973|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
43974|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
43975|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
43976|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
43977|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
43978|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
43979|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
43980|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
43981|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
43982|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
43983|NCT02135016|E3|Reported Event|Group C|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
43984|NCT02135016|E2|Reported Event|Group B|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
43985|NCT02135016|E1|Reported Event|Group A|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
43986|NCT02134977|B1|Baseline|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43987|NCT02134977|P1|Participant Flow|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43988|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43989|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43990|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43991|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43992|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43993|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43994|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43995|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43996|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43997|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43998|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
43999|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
44000|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
44001|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
44002|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
44003|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
44051|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44004|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
44005|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
44006|NCT02134977|E1|Reported Event|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
44007|NCT02134717|B1|Baseline|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.
all subjects will receive maraviroc 300mg orally twice a day for 6 weeks
Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.
venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.
Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
44008|NCT02134717|P1|Participant Flow|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.
all subjects will receive maraviroc 300mg orally twice a day for 6 weeks
Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.
venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.
Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
44009|NCT02134717|O1|Outcome|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.
all subjects will receive maraviroc 300mg orally twice a day for 6 weeks
Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.
venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.
Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
44010|NCT02134717|E1|Reported Event|Sarcoidosis Stage II|"All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.
all subjects will receive maraviroc 300mg orally twice a day for 6 weeks
Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.
venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.
Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies."
44011|NCT02134587|B1|Baseline|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance
Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.
2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
44012|NCT02134587|P1|Participant Flow|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance
Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.
2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
44013|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Skills of health professionals in fill correctly the adverse drug events form before educational intervention
44014|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Skills of health professionals in fill correctly the adverse drug events form after multifaceted educational intervention in pharmacovigilance
Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.
2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
44015|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Knowledge of health professionals before the educational intervention regarding pharmacovigilance
44016|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Knowledge of health professionals after multifaceted educational intervention in pharmacovigilance
Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.
2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
44017|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Number of health professionals who had the potential to report adverse drug reaction, before the educational intervention
44422|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.
44018|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance
Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.
2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
44019|NCT02134587|E1|Reported Event|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance
Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.
2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
44020|NCT02134184|B4|Baseline|Total|Total of all reporting groups
44021|NCT02134184|B3|Baseline|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
44022|NCT02134184|B2|Baseline|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
44023|NCT02134184|B1|Baseline|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
44024|NCT02134184|P3|Participant Flow|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly Recent CMV Conversion is defined as: Donor has donated at least once within the recent timeframe (past three years) AND donor's most recent two donations tested CMV antibody positive AND donor had at least two CMV negative donations in the past"
44025|NCT02134184|P2|Participant Flow|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly"
44026|NCT02134184|P1|Participant Flow|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly"
44027|NCT02134184|O3|Outcome|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly"
44028|NCT02134184|O2|Outcome|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly"
44029|NCT02134184|O1|Outcome|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly"
44030|NCT02134184|O3|Outcome|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly"
44031|NCT02134184|O2|Outcome|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly"
44032|NCT02134184|O1|Outcome|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly"
44033|NCT02134184|E3|Reported Event|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly"
44034|NCT02134184|E2|Reported Event|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly"
44035|NCT02134184|E1|Reported Event|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly"
44036|NCT02134119|B3|Baseline|Total|Total of all reporting groups
44037|NCT02134119|B2|Baseline|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44038|NCT02134119|B1|Baseline|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44039|NCT02134119|P2|Participant Flow|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44040|NCT02134119|P1|Participant Flow|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44041|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44042|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44043|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
74127|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily
IDN-6556"
44044|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44045|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44046|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44047|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44048|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44049|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44050|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
81074|NCT01895946|O1|Outcome|Part A|Part A of the study
44052|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44053|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44054|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44055|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44056|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44057|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44058|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44059|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44060|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44061|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44062|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44063|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44064|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44065|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44066|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44067|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44068|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44069|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44070|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44071|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44072|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44073|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44074|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44075|NCT02134119|E2|Reported Event|Sugar Pill|"Placebo given 8,000mg/day by mouth
Placebo: Sugar pill manufactured to mimic dietary supplement"
44076|NCT02134119|E1|Reported Event|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
44077|NCT02133781|B4|Baseline|Total|Total of all reporting groups
44078|NCT02133781|B3|Baseline|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
44367|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
44080|NCT02133781|B1|Baseline|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
Flumist® 2009-2010 Formula: This vaccine is given intranasally"
44081|NCT02133781|P3|Participant Flow|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
44082|NCT02133781|P2|Participant Flow|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
44083|NCT02133781|P1|Participant Flow|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
Flumist® 2009-2010 Formula: This vaccine is given intranasally"
44084|NCT02133781|O3|Outcome|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
44085|NCT02133781|O2|Outcome|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
44137|NCT02133131|B7|Baseline|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
81075|NCT01895946|O2|Outcome|Part B|Part B of the study
44086|NCT02133781|O1|Outcome|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
Flumist® 2009-2010 Formula: This vaccine is given intranasally"
44087|NCT02133781|O3|Outcome|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
44088|NCT02133781|O2|Outcome|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
44089|NCT02133781|O1|Outcome|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
Flumist® 2009-2010 Formula: This vaccine is given intranasally"
44090|NCT02133781|E3|Reported Event|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
44091|NCT02133781|E2|Reported Event|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
44092|NCT02133781|E1|Reported Event|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
Flumist® 2009-2010 Formula: This vaccine is given intranasally"
44093|NCT02133664|B3|Baseline|Total|Total of all reporting groups
44094|NCT02133664|B2|Baseline|Placebo|"placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil"
44095|NCT02133664|B1|Baseline|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids
Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
44096|NCT02133664|P2|Participant Flow|Placebo|"placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil"
44097|NCT02133664|P1|Participant Flow|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids
lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
44098|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil"
44099|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids
lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
44100|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil"
44101|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids
lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
44102|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil"
44103|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids
lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
44104|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil"
44105|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids
lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
44106|NCT02133664|E2|Reported Event|Placebo|"placebo oil and placebo lipoic acid
Placebo: placebo lipoic acid and placebo oil"
44107|NCT02133664|E1|Reported Event|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids
Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
44108|NCT02133534|B1|Baseline|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.
Atorvastatin"
44131|NCT02133235|O3|Outcome|Right-sided VATS, Auscultation Group|patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
74128|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily
IDN-6556"
44109|NCT02133534|P1|Participant Flow|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.
Atorvastatin"
44110|NCT02133534|O1|Outcome|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.
Atorvastatin"
44135|NCT02133235|E1|Reported Event|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
44111|NCT02133534|E1|Reported Event|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.
Atorvastatin"
44112|NCT02133352|B1|Baseline|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.
Ranolazine: Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
44113|NCT02133352|P1|Participant Flow|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.
Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
44114|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.
Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
44115|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.
Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
44116|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.
Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
44117|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.
Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
44118|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.
Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
44119|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.
Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
44120|NCT02133352|E1|Reported Event|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.
Ranolazine: Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
44121|NCT02133235|B3|Baseline|Total|Total of all reporting groups
44122|NCT02133235|B2|Baseline|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
44123|NCT02133235|B1|Baseline|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
44124|NCT02133235|P2|Participant Flow|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
44125|NCT02133235|P1|Participant Flow|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
44126|NCT02133235|O4|Outcome|Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group|patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
44127|NCT02133235|O3|Outcome|Right-sided VATS, Auscultation Group|patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
44128|NCT02133235|O2|Outcome|Left-sided VATS, Conventional Fiberoptic Brochoscopy Group|patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
44129|NCT02133235|O1|Outcome|Left-sided VATS, Auscultation Group|patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
44130|NCT02133235|O4|Outcome|Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group|patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
44132|NCT02133235|O2|Outcome|Left-sided VATS, Conventional Fiberoptic Brochoscopy Group|patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
44133|NCT02133235|O1|Outcome|Left-sided VATS, Auscultation Group|patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
44134|NCT02133235|E2|Reported Event|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
44136|NCT02133131|B8|Baseline|Total|Total of all reporting groups
44423|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.
44138|NCT02133131|B6|Baseline|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44139|NCT02133131|B5|Baseline|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44140|NCT02133131|B4|Baseline|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44141|NCT02133131|B3|Baseline|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44142|NCT02133131|B2|Baseline|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44143|NCT02133131|B1|Baseline|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
44144|NCT02133131|P7|Participant Flow|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44145|NCT02133131|P6|Participant Flow|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44146|NCT02133131|P5|Participant Flow|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44147|NCT02133131|P4|Participant Flow|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44148|NCT02133131|P3|Participant Flow|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44149|NCT02133131|P2|Participant Flow|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44150|NCT02133131|P1|Participant Flow|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
44151|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44152|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44153|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44154|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44155|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44156|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44157|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
44158|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44159|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44160|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44161|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44162|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44163|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44164|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
44165|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44166|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44167|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44168|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44169|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44368|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
44172|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44173|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44174|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44175|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44176|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44177|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44178|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
44179|NCT02133131|E7|Reported Event|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44180|NCT02133131|E6|Reported Event|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
44181|NCT02133131|E5|Reported Event|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44182|NCT02133131|E4|Reported Event|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
44183|NCT02133131|E3|Reported Event|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44184|NCT02133131|E2|Reported Event|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
44185|NCT02133131|E1|Reported Event|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
44186|NCT02133066|B3|Baseline|Total|Total of all reporting groups
44187|NCT02133066|B2|Baseline|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
44188|NCT02133066|B1|Baseline|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
44189|NCT02133066|P2|Participant Flow|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
44190|NCT02133066|P1|Participant Flow|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
44191|NCT02133066|O2|Outcome|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
44192|NCT02133066|O1|Outcome|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
44193|NCT02133066|O2|Outcome|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
44194|NCT02133066|O1|Outcome|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
44195|NCT02133066|O2|Outcome|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
44196|NCT02133066|O1|Outcome|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
44197|NCT02133066|O2|Outcome|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
44234|NCT02132936|B3|Baseline|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
Calcipotriol BDP gel"
44235|NCT02132936|B2|Baseline|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
Aerosol foam vehicle"
44198|NCT02133066|O1|Outcome|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
44199|NCT02133066|E2|Reported Event|Routine Lumbar Puncture|"These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care"
44200|NCT02133066|E1|Reported Event|US-Assisted Site Marking for LP|"Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap"
44201|NCT02132949|B3|Baseline|Total|Total of all reporting groups
81076|NCT01895946|O1|Outcome|Part A|Part A of the study
44202|NCT02132949|B2|Baseline|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44203|NCT02132949|B1|Baseline|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 milligrams per square meter (mg/m^2; as an intravenous [IV] bolus over 3-5 minutes [min] or as an infusion over 15-30min) once in every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion once weekly (qw) for 12 weeks. Pertuzumab 840 milligrams (mg) loading dose IV, then 420mg IV q3w and trastuzumab 8 milligrams per kilogram (mg/kg) loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44204|NCT02132949|P2|Participant Flow|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44205|NCT02132949|P1|Participant Flow|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 milligrams per square meter (mg/m^2; as an intravenous [IV] bolus over 3-5 minutes [min] or as an infusion over 15-30min) once in every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion once weekly (qw) for 12 weeks. Pertuzumab 840 milligrams (mg) loading dose IV, then 420mg IV q3w and trastuzumab 8 milligrams per kilogram (mg/kg) loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44206|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44207|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44236|NCT02132936|B1|Baseline|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
LEO 90100 aerosol foam"
44237|NCT02132936|P4|Participant Flow|Gel Vehicle|Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
44278|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44208|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44247|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
Calcipotriol BDP gel"
44424|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.
44209|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44210|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44211|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44212|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44213|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44214|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44215|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44238|NCT02132936|P3|Participant Flow|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
44239|NCT02132936|P2|Participant Flow|Aerosol Foam Vehicle|Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
44216|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44217|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44218|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44219|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44220|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44221|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44222|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44223|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44240|NCT02132936|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
44241|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
44224|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44225|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44226|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44227|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44228|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44229|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44230|NCT02132949|E2|Reported Event|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44231|NCT02132949|E1|Reported Event|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 milligrams per square meter (mg/m^2; as an intravenous [IV] bolus over 3-5 minutes [min] or as an infusion over 15-30min) once in every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion once weekly (qw) for 12 weeks. Pertuzumab 840 milligrams (mg) loading dose IV, then 420mg IV q3w and trastuzumab 8 milligrams per kilogram (mg/kg) loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
44232|NCT02132936|B5|Baseline|Total|Total of all reporting groups
44233|NCT02132936|B4|Baseline|Gel Vehicle|"Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
Gel vehicle"
44242|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
44243|NCT02132936|O2|Outcome|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
Aerosol foam vehicle"
44244|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
44245|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
44246|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
44248|NCT02132936|O1|Outcome|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
LEO 90100 aerosol foam"
44249|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
44250|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
44251|NCT02132936|E4|Reported Event|Gel Vehicle|"Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
Gel vehicle"
44252|NCT02132936|E3|Reported Event|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
Calcipotriol BDP gel"
44253|NCT02132936|E2|Reported Event|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
Aerosol foam vehicle"
44254|NCT02132936|E1|Reported Event|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
LEO 90100 aerosol foam"
44255|NCT02132832|B3|Baseline|Total|Total of all reporting groups
44256|NCT02132832|B2|Baseline|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44257|NCT02132832|B1|Baseline|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44258|NCT02132832|P2|Participant Flow|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44259|NCT02132832|P1|Participant Flow|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44260|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44261|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44262|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44263|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44264|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44265|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44266|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44267|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44268|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44269|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44270|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44271|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44272|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44273|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44274|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44275|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44276|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44277|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
74129|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily
IDN-6556"
44279|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44280|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44281|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44282|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44283|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44284|NCT02132832|E2|Reported Event|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
44285|NCT02132832|E1|Reported Event|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
44286|NCT02132767|B3|Baseline|Total|Total of all reporting groups
44287|NCT02132767|B2|Baseline|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
44288|NCT02132767|B1|Baseline|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
44289|NCT02132767|P2|Participant Flow|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
44290|NCT02132767|P1|Participant Flow|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
44291|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
44292|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
44309|NCT02132611|B1|Baseline|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
46815|NCT02114268|O1|Outcome|Placebo|Participants received placebo on Day 1.
44293|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
44312|NCT02132611|O1|Outcome|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
44294|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
44295|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
44296|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
44297|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
44298|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
44299|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
44300|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
44357|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
44358|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
44359|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
44301|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
44302|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
44303|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
44304|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
44305|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
44306|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
44307|NCT02132767|E2|Reported Event|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
44308|NCT02132767|E1|Reported Event|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
44360|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
44361|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
44362|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
44310|NCT02132611|P1|Participant Flow|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
44311|NCT02132611|O1|Outcome|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
44313|NCT02132611|E1|Reported Event|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
44314|NCT02132572|B1|Baseline|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
44315|NCT02132572|P1|Participant Flow|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
44316|NCT02132572|O1|Outcome|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
44317|NCT02132572|E1|Reported Event|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
44318|NCT02132169|B3|Baseline|Total|Total of all reporting groups
44319|NCT02132169|B2|Baseline|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
44320|NCT02132169|B1|Baseline|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
44321|NCT02132169|P2|Participant Flow|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
44322|NCT02132169|P1|Participant Flow|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
44323|NCT02132169|O2|Outcome|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
44324|NCT02132169|O1|Outcome|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
44325|NCT02132169|O2|Outcome|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
44326|NCT02132169|O1|Outcome|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
44327|NCT02132169|O2|Outcome|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
44328|NCT02132169|O1|Outcome|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
44329|NCT02132169|O2|Outcome|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
44330|NCT02132169|O1|Outcome|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
44331|NCT02132169|E2|Reported Event|AC-170 0%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
44332|NCT02132169|E1|Reported Event|AC-170 0.24%|1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%
44333|NCT02132117|B3|Baseline|Total|Total of all reporting groups
44334|NCT02132117|B2|Baseline|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
44335|NCT02132117|B1|Baseline|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
44336|NCT02132117|P2|Participant Flow|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
44337|NCT02132117|P1|Participant Flow|Oxymetazoline HCL Cream 1.0%|Oxymetazoline hydrochloride (HCL) Cream 1.0% applied to the face once daily for 29 days.
44338|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
44339|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
44340|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
44341|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
44342|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
44343|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
44344|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
44345|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
44346|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
44347|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
44348|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
44349|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
44350|NCT02132117|E2|Reported Event|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
44351|NCT02132117|E1|Reported Event|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
44352|NCT02131636|B3|Baseline|Total|Total of all reporting groups
44353|NCT02131636|B2|Baseline|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
44354|NCT02131636|B1|Baseline|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
44355|NCT02131636|P2|Participant Flow|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
44356|NCT02131636|P1|Participant Flow|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
44369|NCT02131636|E2|Reported Event|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
44370|NCT02131636|E1|Reported Event|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
44371|NCT02131532|B1|Baseline|Intervention Group|Baseline characteristics of eight participants who completed all treatment sessions
44372|NCT02131532|P1|Participant Flow|Psychological Intervention|All participants were enrolled in this group, receiving a psychological intervention for the treatment of post-stroke fatigue.
44373|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44374|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44375|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44421|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
44376|NCT02131532|O1|Outcome|Intervention Group|This outcome presents the recruitment process. However, only eight participants who completed all treatment sessions were included for further analysis of clinical outcomes.
44377|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44378|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44379|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44380|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44381|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44382|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44383|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44384|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44385|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44386|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44387|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44388|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44389|NCT02131532|E1|Reported Event|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
44390|NCT02131402|B1|Baseline|Enfilcon A / Omafilcon A/Ocufilcon D/Methafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.
Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contralateral eye. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye."
44391|NCT02131402|P1|Participant Flow|Overall Participants Flow|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.
omafilcon A/ocufilcon D/methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A)/(ocufilcon D)/(methafilcon A)in the contra lateral eye."
44392|NCT02131402|O2|Outcome|Methafilcon A|Participants vision tested both eyes wearing Methafilcon A, prior to dispensing contralateral pairs.
44393|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
44394|NCT02131402|O2|Outcome|Ocufilcon D|Participants vision tested both eyes wearing ocufilcon D, prior to dispensing contralateral pairs.
44395|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
44396|NCT02131402|O2|Outcome|Omafilcon A|Participants vision tested both eyes wearing omafilcon A, prior to dispensing contralateral pairs.
44397|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
44398|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed at 1 hour post settling, wearing Methafilcon A in contralateral eye.
44399|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at 1 hour post settling, wearing Enfilcon A in one eye.
44400|NCT02131402|O2|Outcome|Ocufilcon D|Participants surveyed at 1 hour post settling, wearing Ocufilcon D in contralateral eye.
44401|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at 1 hour post settling, wearing Enfilcon A in one eye.
44402|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after1 hour wearing Omafilcon A in contralateral eye.
44403|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour wearing Enfilcon A in one eye.
44404|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed at baseline, wearing Methafilcon A in contralateral eye.
44405|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye.
44406|NCT02131402|O2|Outcome|Ocufilcon D|Surveyed after insertion at baseline, wearing Ocufilcon D in contralateral eye.
44407|NCT02131402|O1|Outcome|Enfilcon A|Surveyed after insertion at baseline, wearing Enfilcon A in one eye.
44408|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed at baseline, wearing Omafilcon A in contralateral eye
44409|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye
44410|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling, wearing Methafilcon A in contralateral eye.
44411|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling, wearing Enfilcon A in one eye.
44412|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling, wearing Ocufilcon D in contralateral eye.
44413|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling, wearing Enfilcon A in one eye.
44414|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling, wearing Omafilcon A in contralateral eye
44415|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling wearing Enfilcon A in one eye.
44416|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling. Push up test, wearing Methafilcon A in contralateral eye.
44417|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
44418|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling. Push up test, wearing Ocufilcon D in contralateral eye.
44419|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
44420|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling. Push up test, wearing Omafilcon A in contralateral eye.
44425|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye
44426|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Omafilcon A in contralateral eye.
44427|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.
44428|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contralateral eye, surveyed at 1 hour post settling.
44429|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye, surveyed at 1 hour post settling.
44430|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in contralateral eye. Surveyed after 1 hour post settling.
44431|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling.
44432|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye
44433|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
44434|NCT02131402|O2|Outcome|Methafilcon A|Subject surveyed after insertion of each lens for Pair #3 wearing Methafilcon A in the contralateral eye.
44435|NCT02131402|O1|Outcome|Enfilcon A|Subject surveyed after insertion of each lens for Pair #3 wearing Enfilcon A in one eye
44436|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contralateral eye. Surveyed at insertion of each lens Pair #2.
44437|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed at insertion of each lens Pair #2.
44438|NCT02131402|O2|Outcome|Omafilcon A|Subject after insertion of Pair #1 at baseline wearing Omafilcon A in the contralateral eye.
44439|NCT02131402|O1|Outcome|Enfilcon A|Subject after insertion of Pair #1 at baseline wearing Enfilcon A in one eye
44440|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed after 1 post settling hour, wearing Methafilcon A in the contra lateral eye.
44441|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
44442|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contra lateral eye. Surveyed after 1 hour post settling for Pair #2.
44443|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling for Pair #2
44444|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye
44445|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
44446|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contra lateral eye. Participants surveyed at insertion.
44447|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Participants surveyed at insertion.
44448|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed at baseline, wearing Omafilcon A in the contra lateral eye.
44449|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye
44450|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contra lateral eye. Surveyed after insertion of each lens Pair #2 (at insertion).
44451|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after insertion of each lens Pair #2 (at insertion).
44452|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.
44453|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.
44454|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2
44455|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2.
44456|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
44457|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.
44458|NCT02131402|E3|Reported Event|Enfilcon A / Methafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.
methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye."
44459|NCT02131402|E2|Reported Event|Enfilcon A / Ocufilcon D|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.
ocufilcon D: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye."
46894|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
44460|NCT02131402|E1|Reported Event|Enfilcon A / Omafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.
omafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye."
44461|NCT02131311|B1|Baseline|Pessary|disposable, single-use pessary
44462|NCT02131311|P1|Participant Flow|Pessary|disposable, single-use pessary
44463|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
44464|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
44465|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
44466|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
44467|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
44468|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
44469|NCT02131311|O1|Outcome|Pessary|"disposable, single-use pessary
disposable, single-use pessary"
44470|NCT02131311|E1|Reported Event|Pessary|disposable, single-use pessary
44471|NCT02131233|B3|Baseline|Total|Total of all reporting groups
81077|NCT01895946|O2|Outcome|Part B|Part B of the study
44472|NCT02131233|B2|Baseline|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
44473|NCT02131233|B1|Baseline|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
44474|NCT02131233|P2|Participant Flow|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
44475|NCT02131233|P1|Participant Flow|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
44476|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
44477|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
44478|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
44479|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
44480|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
44481|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
44482|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
44483|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
44484|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
44485|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
44486|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
44487|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
44488|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
44489|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
44490|NCT02131233|E2|Reported Event|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
44491|NCT02131233|E1|Reported Event|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
44492|NCT02131064|B3|Baseline|Total|Total of all reporting groups
44493|NCT02131064|B2|Baseline|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44494|NCT02131064|B1|Baseline|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44495|NCT02131064|P2|Participant Flow|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44496|NCT02131064|P1|Participant Flow|TCH + P|Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44497|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44498|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44729|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
81078|NCT01895946|O1|Outcome|Part A|Part A of the study
44499|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44500|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44501|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44502|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44503|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44504|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44505|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44506|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44507|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44508|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44509|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44510|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44511|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44529|NCT02130999|P1|Participant Flow|Sequence A|"Single oral dose of tasimelteon 20 mg on Day 1
Single I.V. dose of tasimelteon 2 mg on Day 6
tasimelteon 20 mg capsule
tasimelteon 2 mg I.V."
44530|NCT02130999|O3|Outcome|All Subjects|
44531|NCT02130999|O2|Outcome|Tasimelteon 2mg IV|
44512|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44513|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44557|NCT02130635|B7|Baseline|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
49495|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
44514|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44515|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44516|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44517|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44518|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44519|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44520|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44521|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44522|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44523|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44524|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44525|NCT02131064|E2|Reported Event|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
44526|NCT02131064|E1|Reported Event|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
44527|NCT02130999|B1|Baseline|Overall Number of Baseline Participants|14 subjects total participated in the study
44528|NCT02130999|P2|Participant Flow|Sequence B|"Single I.V. dose of tasimelteon 2 mg on Day 1
Single oral dose of tasimelteon 20 mg on Day 6
tasimelteon 20 mg capsule
tasimelteon 2 mg I.V."
44532|NCT02130999|O1|Outcome|Tasimelteon 20mg Oral|
44533|NCT02130999|O3|Outcome|All Subjects|
44555|NCT02130635|B9|Baseline|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44556|NCT02130635|B8|Baseline|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44726|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44558|NCT02130635|B6|Baseline|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44559|NCT02130635|B5|Baseline|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44560|NCT02130635|B4|Baseline|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44561|NCT02130635|B3|Baseline|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44562|NCT02130635|B2|Baseline|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44563|NCT02130635|B1|Baseline|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44564|NCT02130635|P9|Participant Flow|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44565|NCT02130635|P8|Participant Flow|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44566|NCT02130635|P7|Participant Flow|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44567|NCT02130635|P6|Participant Flow|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44568|NCT02130635|P5|Participant Flow|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44569|NCT02130635|P4|Participant Flow|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44570|NCT02130635|P3|Participant Flow|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44571|NCT02130635|P2|Participant Flow|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44572|NCT02130635|P1|Participant Flow|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44573|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44574|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44575|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44576|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44577|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44578|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
74130|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily
IDN-6556"
44579|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44580|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44581|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44727|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44582|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44583|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44584|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44585|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44586|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44587|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44588|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44589|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44590|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44591|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44592|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44593|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44594|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44595|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44596|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44597|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44598|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44599|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44600|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44601|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44723|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44725|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44602|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44603|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
45011|NCT02128867|E2|Reported Event|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD
bouncing combined with AAD"
44604|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44605|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44606|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44607|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44608|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44609|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44610|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44611|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44612|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44613|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44614|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44615|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44616|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44617|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44618|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44619|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44620|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44621|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44622|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44623|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44624|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
45007|NCT02128867|O3|Outcome|Bouncing|"bouncing as control group. intervention to relax the infant
bouncing"
44625|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44626|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44627|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44628|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44629|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44630|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44631|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44632|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44633|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44634|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44635|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44636|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44637|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44638|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44639|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44640|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44641|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44642|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44643|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44644|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44645|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44646|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44647|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
45458|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
44648|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44649|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
45699|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
44650|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44651|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44652|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44653|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44654|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44655|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44656|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44657|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44658|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44659|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44660|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44661|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44662|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44663|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44664|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44665|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44666|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44667|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44668|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44669|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44670|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44724|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44671|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
45012|NCT02128867|E1|Reported Event|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage
Assisted Autogenic Drainage (AAD)"
44672|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44673|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44674|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44675|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44676|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44677|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44678|NCT02130635|O6|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44679|NCT02130635|O5|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44680|NCT02130635|O4|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44681|NCT02130635|O3|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44682|NCT02130635|O2|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44683|NCT02130635|O1|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44684|NCT02130635|O1|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44685|NCT02130635|O6|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44686|NCT02130635|O5|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44687|NCT02130635|O4|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44688|NCT02130635|O3|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44689|NCT02130635|O2|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44690|NCT02130635|O1|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44691|NCT02130635|O1|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44692|NCT02130635|O6|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44693|NCT02130635|O5|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44728|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44694|NCT02130635|O4|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44695|NCT02130635|O3|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44696|NCT02130635|O2|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44697|NCT02130635|O1|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44698|NCT02130635|O1|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44699|NCT02130635|O7|Outcome|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44700|NCT02130635|O6|Outcome|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44701|NCT02130635|O5|Outcome|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44702|NCT02130635|O4|Outcome|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44703|NCT02130635|O3|Outcome|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44704|NCT02130635|O2|Outcome|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44705|NCT02130635|O1|Outcome|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44706|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44707|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44708|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44709|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44710|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44711|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44712|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44713|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44714|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44715|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44716|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44717|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44718|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44719|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44720|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44721|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44722|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44730|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44731|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44732|NCT02130635|O2|Outcome|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44733|NCT02130635|O1|Outcome|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44734|NCT02130635|E9|Reported Event|Part B: GSK2269577 2000 µg|Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
44735|NCT02130635|E8|Reported Event|Part B: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44736|NCT02130635|E7|Reported Event|Part B: GSK2269577 700 µg|Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.
44737|NCT02130635|E6|Reported Event|Part B: GSK2269577 500 µg|Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.
44738|NCT02130635|E5|Reported Event|Part B: GSK2269577 200 µg|Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44739|NCT02130635|E4|Reported Event|Part B: GSK2269577 100 µg|Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.
44740|NCT02130635|E3|Reported Event|Part B: Placebo|Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.
44741|NCT02130635|E2|Reported Event|Part A: GSK2269577 1000 µg|Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.
44742|NCT02130635|E1|Reported Event|Part A: Placebo|Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.
44743|NCT02130284|B1|Baseline|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
44744|NCT02130284|P1|Participant Flow|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
44745|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
44746|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
44747|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
44748|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
44749|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
74131|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily
IDN-6556"
44750|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
44770|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44751|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
44752|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
44753|NCT02130284|E1|Reported Event|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
44754|NCT02130193|B3|Baseline|Total|Total of all reporting groups
44755|NCT02130193|B2|Baseline|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44756|NCT02130193|B1|Baseline|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44757|NCT02130193|P3|Participant Flow|Part B: 52-week Double-blind Period: DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44758|NCT02130193|P2|Participant Flow|Part B: 52-week Double-blind Period: Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44759|NCT02130193|P1|Participant Flow|Part A: 4-week Open-label Period: DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44760|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44761|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44762|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44763|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44764|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44765|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44766|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44767|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44768|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
45459|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
44769|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44771|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44772|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44773|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44774|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44775|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44776|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44777|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44778|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44779|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44780|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44781|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44782|NCT02130193|O1|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44783|NCT02130193|O1|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44784|NCT02130193|O1|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44785|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44786|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44787|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44788|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44789|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
45013|NCT02128542|B3|Baseline|Total|Total of all reporting groups
44790|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44791|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44792|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44793|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44794|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44795|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44796|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44797|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44798|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44799|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44800|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44801|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44802|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44803|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44804|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44805|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44806|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44807|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
45460|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
44808|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44809|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44810|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44811|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44812|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44813|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44814|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44815|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44816|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44817|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44818|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44819|NCT02130193|E3|Reported Event|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44820|NCT02130193|E2|Reported Event|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44821|NCT02130193|E1|Reported Event|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
44822|NCT02129777|B6|Baseline|Total|Total of all reporting groups
44823|NCT02129777|B5|Baseline|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44824|NCT02129777|B4|Baseline|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44825|NCT02129777|B3|Baseline|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44826|NCT02129777|B2|Baseline|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44827|NCT02129777|B1|Baseline|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44828|NCT02129777|P7|Participant Flow|Open-Label Period: Namilumab 150 mg|Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
44829|NCT02129777|P6|Participant Flow|Open-Label Period: Namilumab 80 mg|Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
44830|NCT02129777|P5|Participant Flow|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44831|NCT02129777|P4|Participant Flow|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44832|NCT02129777|P3|Participant Flow|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
45008|NCT02128867|O2|Outcome|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD
bouncing combined with AAD"
44833|NCT02129777|P2|Participant Flow|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44834|NCT02129777|P1|Participant Flow|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44835|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44836|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44837|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44838|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44839|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44840|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44841|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44842|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44843|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44844|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44845|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44846|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44847|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44848|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44849|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44850|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44851|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44852|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44853|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44854|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44855|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44856|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
45003|NCT02128867|B1|Baseline|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage
Assisted Autogenic Drainage (AAD)"
44857|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44858|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44859|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44860|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44861|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44862|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44863|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44864|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44865|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44866|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44867|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44868|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44869|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44870|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44871|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44872|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44873|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44874|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44875|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44876|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44877|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44878|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44879|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44880|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44881|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44882|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
45004|NCT02128867|P3|Participant Flow|Bouncing|"bouncing as control group. intervention to relax the infant
bouncing"
47955|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
44883|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44884|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44885|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44886|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44887|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44888|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44889|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44890|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44891|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44892|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44893|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44894|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44895|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44896|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44897|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44898|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44899|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44900|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44901|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44902|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44903|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44904|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44905|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44906|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44907|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44908|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
45005|NCT02128867|P2|Participant Flow|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD
bouncing combined with AAD"
44909|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44910|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44911|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44912|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44913|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44914|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44915|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44916|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44917|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44918|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44919|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44920|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44921|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44922|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44923|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44924|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44925|NCT02129777|E12|Reported Event|Follow-up: Namilumab 150 mg|Participants who received namilumab 150 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
44926|NCT02129777|E11|Reported Event|Follow-up Period: Namilumab 80 mg|Participants who received namilumab 80 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
44927|NCT02129777|E10|Reported Event|Follow-up Period: Namilumab 50 mg|Participants who received namilumab 50 mg injections during the double-blind treatment were to be followed-up after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
44928|NCT02129777|E9|Reported Event|Follow-up Period: Namilumab 20 mg|Participants who received namilumab 20 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
44929|NCT02129777|E8|Reported Event|Follow-up Period: Placebo|Participants who received namilumab-matching placebo injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
44930|NCT02129777|E7|Reported Event|Open-Label Period: Namilumab 150 mg|Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
44931|NCT02129777|E6|Reported Event|Open-Label Period: Namilumab 80 mg|Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
44932|NCT02129777|E5|Reported Event|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44933|NCT02129777|E4|Reported Event|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44934|NCT02129777|E3|Reported Event|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
45461|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
44935|NCT02129777|E2|Reported Event|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
45009|NCT02128867|O1|Outcome|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage
Assisted Autogenic Drainage (AAD)"
46125|NCT02118896|B11|Baseline|Total|Total of all reporting groups
44936|NCT02129777|E1|Reported Event|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
44937|NCT02129725|B3|Baseline|Total|Total of all reporting groups
44938|NCT02129725|B2|Baseline|Placebo|Subjects consented for the biopsy substudy and randomized
44939|NCT02129725|B1|Baseline|Sildenafil|Subjects consented for the biopsy substudy and randomized
44940|NCT02129725|P2|Participant Flow|Placebo|"In the parent study, subjects are randomized to matching placebo
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
44941|NCT02129725|P1|Participant Flow|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
44942|NCT02129725|O2|Outcome|Placebo|"In the parent study, subjects are randomized to matching placebo
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
44943|NCT02129725|O1|Outcome|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
44944|NCT02129725|E2|Reported Event|Placebo|"In the parent study, subjects are randomized to matching placebo
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
44945|NCT02129725|E1|Reported Event|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
44946|NCT02129608|B4|Baseline|Total|Total of all reporting groups
44947|NCT02129608|B3|Baseline|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
Lorcaserin: 10 mg pills twice daily for 12 weeks."
44948|NCT02129608|B2|Baseline|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks."
44949|NCT02129608|B1|Baseline|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
44950|NCT02129608|P3|Participant Flow|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
Lorcaserin: 10 mg pills twice daily for 12 weeks."
44951|NCT02129608|P2|Participant Flow|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks."
44952|NCT02129608|P1|Participant Flow|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
44953|NCT02129608|O3|Outcome|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
Lorcaserin: 10 mg pills twice daily for 12 weeks."
44954|NCT02129608|O2|Outcome|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks."
44955|NCT02129608|O1|Outcome|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
44956|NCT02129608|O3|Outcome|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
Lorcaserin: 10 mg pills twice daily for 12 weeks."
44957|NCT02129608|O2|Outcome|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks."
44958|NCT02129608|O1|Outcome|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
44959|NCT02129608|E3|Reported Event|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
Lorcaserin: 10 mg pills twice daily for 12 weeks."
44960|NCT02129608|E2|Reported Event|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks."
44961|NCT02129608|E1|Reported Event|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
44962|NCT02129192|B3|Baseline|Total|Total of all reporting groups
45006|NCT02128867|P1|Participant Flow|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage
Assisted Autogenic Drainage (AAD)"
74132|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily
IDN-6556"
45010|NCT02128867|E3|Reported Event|Bouncing|"bouncing as control group. intervention to relax the infant
bouncing"
45124|NCT02126748|E3|Reported Event|Control|20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day
44963|NCT02129192|B2|Baseline|Sequence RTTR|"Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4:
R - T - T - R.
The treatments were administered following an overnight fast of at least 10 hours."
44964|NCT02129192|B1|Baseline|Sequence TRRTT|"Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5:
T (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T.
Treatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration"
44965|NCT02129192|P2|Participant Flow|Sequence RTTR|"Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4:
R - T - T - R.
The treatments were administered following an overnight fast of at least 10 hours."
44966|NCT02129192|P1|Participant Flow|Sequence TRRTT|"Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5:
T (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T.
Treatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration"
44967|NCT02129192|O2|Outcome|T80/A5/H12.5 FDC Fasted|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition
44968|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC Fed|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition
44969|NCT02129192|O2|Outcome|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
44970|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
44971|NCT02129192|O2|Outcome|T80/A5/H12.5 FDC Fasted|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition
44972|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC Fed|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition
44973|NCT02129192|O2|Outcome|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
44974|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
44975|NCT02129192|O2|Outcome|T80/A5/H12.5 FDC Fasted|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition
44976|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC Fed|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition
44977|NCT02129192|O2|Outcome|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
44978|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
44979|NCT02129192|E3|Reported Event|Total.|All participants randomised into the study.
44980|NCT02129192|E2|Reported Event|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
44981|NCT02129192|E1|Reported Event|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
44982|NCT02129062|B1|Baseline|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
44983|NCT02129062|P1|Participant Flow|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
44984|NCT02129062|O1|Outcome|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
44985|NCT02129062|O1|Outcome|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
44986|NCT02129062|E1|Reported Event|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
44987|NCT02128919|B3|Baseline|Total|Total of all reporting groups
44988|NCT02128919|B2|Baseline|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days
tDCS: Transcranial Direct Current Stimulation"
44989|NCT02128919|B1|Baseline|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days
tDCS: Transcranial Direct Current Stimulation"
44990|NCT02128919|P2|Participant Flow|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days
tDCS: Transcranial Direct Current Stimulation"
44991|NCT02128919|P1|Participant Flow|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days
tDCS: Transcranial Direct Current Stimulation"
44992|NCT02128919|O2|Outcome|Sham tDCS|"tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days
tDCS: Transcranial Direct Current Stimulation"
44993|NCT02128919|O1|Outcome|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days
tDCS: Transcranial Direct Current Stimulation"
44994|NCT02128919|O2|Outcome|Sham tDCS|"tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days
tDCS: Transcranial Direct Current Stimulation"
44995|NCT02128919|O1|Outcome|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days
tDCS: Transcranial Direct Current Stimulation"
44996|NCT02128919|O2|Outcome|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days
tDCS: Transcranial Direct Current Stimulation"
44997|NCT02128919|O1|Outcome|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days
tDCS: Transcranial Direct Current Stimulation"
44998|NCT02128919|E2|Reported Event|Sham tDCS|"tDCS 2 ma for 40 second s with anode at DLPFC for 5 days
tDCS: Transcranial Direct Current Stimulation"
44999|NCT02128919|E1|Reported Event|Active tDCS|"tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days
tDCS: Transcranial Direct Current Stimulation"
45000|NCT02128867|B4|Baseline|Total|Total of all reporting groups
45001|NCT02128867|B3|Baseline|Bouncing|"bouncing . intervention to relax the infant
bouncing"
45002|NCT02128867|B2|Baseline|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD
bouncing combined with AAD"
45014|NCT02128542|B2|Baseline|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45015|NCT02128542|B1|Baseline|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45016|NCT02128542|P2|Participant Flow|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45017|NCT02128542|P1|Participant Flow|SOF+RBV 12 Weeks (TN)|Treatment-naive (TN) participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45018|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (All)|All participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45019|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45020|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45021|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45022|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45023|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45024|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45025|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (All)|All participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45026|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45027|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45028|NCT02128542|E1|Reported Event|SOF+RBV 12 Weeks (All Participants)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
45029|NCT02128490|B6|Baseline|Total|Total of all reporting groups
45030|NCT02128490|B5|Baseline|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45031|NCT02128490|B4|Baseline|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45032|NCT02128490|B3|Baseline|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45033|NCT02128490|B2|Baseline|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45034|NCT02128490|B1|Baseline|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45035|NCT02128490|P5|Participant Flow|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45036|NCT02128490|P4|Participant Flow|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45037|NCT02128490|P3|Participant Flow|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45038|NCT02128490|P2|Participant Flow|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45039|NCT02128490|P1|Participant Flow|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45040|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45416|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
45041|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45042|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45043|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45044|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45045|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45046|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45047|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45048|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45049|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45050|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45051|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45052|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45053|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45054|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45055|NCT02128490|E5|Reported Event|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45056|NCT02128490|E4|Reported Event|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45057|NCT02128490|E3|Reported Event|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45058|NCT02128490|E2|Reported Event|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45059|NCT02128490|E1|Reported Event|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
45060|NCT02128269|B1|Baseline|ALXN1007- Open Label Study|"ALXN1007
ALXN1007: 10 mg/kg IV q 2 weeks x 12 doses"
45061|NCT02128269|P1|Participant Flow|ALXN1007|ALXN1007 10 mg/kg IV q 2 weeks x 12 doses
45062|NCT02128269|O1|Outcome|ALXN1007|ALXN1007 10 mg/kg IV q 2 weeks x 12 doses
45063|NCT02128269|E1|Reported Event|ALXN1007- Open Label Study|"ALXN1007
ALXN1007: 10 mg/kg IV q 2 weeks x 12 doses"
45064|NCT02127567|B1|Baseline|All Participants|
45065|NCT02127567|P1|Participant Flow|All Participants|"All participants were asked to write the six parts or 'domains' of the methods section describing a randomized controlled trial. Each participant completed 3 parts or 'domains' with the tool and 3 without.
online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
45077|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting
online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
45066|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.
writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
45125|NCT02126748|E2|Reported Event|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
inhalation 4ml hypertonic saline 3% 3x/day
Assisted Autogenic Drainage"
45067|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting
online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
45068|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.
writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
45069|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting
online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
45070|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.
writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
45071|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting
online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
45072|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.
writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
45073|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting
online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
45074|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.
writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
45075|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting
online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
45076|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.
writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
45121|NCT02126748|O3|Outcome|Control|20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
74133|NCT01937130|E4|Reported Event|Placebo|"Dosed twice daily
Placebo"
45078|NCT02127567|O2|Outcome|Writing With no Specific Support.|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.
writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
45079|NCT02127567|O1|Outcome|Online Writing Tool|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting
online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
45080|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.
writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
45081|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting
online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
45082|NCT02127567|E2|Reported Event|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.
writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
45083|NCT02127567|E1|Reported Event|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting
online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
45084|NCT02127372|B3|Baseline|Total|Total of all reporting groups
45085|NCT02127372|B2|Baseline|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
45086|NCT02127372|B1|Baseline|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
45087|NCT02127372|P2|Participant Flow|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
45088|NCT02127372|P1|Participant Flow|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
45089|NCT02127372|O1|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
45090|NCT02127372|O2|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
45091|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
45092|NCT02127372|O1|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
45093|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
45259|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45094|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
45095|NCT02127372|E2|Reported Event|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
45096|NCT02127372|E1|Reported Event|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
45097|NCT02127307|B1|Baseline|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
45098|NCT02127307|P1|Participant Flow|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
45099|NCT02127307|O1|Outcome|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
45100|NCT02127307|E1|Reported Event|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
45101|NCT02126839|B3|Baseline|Total|Total of all reporting groups
45102|NCT02126839|B2|Baseline|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
45103|NCT02126839|B1|Baseline|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
45104|NCT02126839|P2|Participant Flow|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
45105|NCT02126839|P1|Participant Flow|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
45106|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
45107|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
45108|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
45109|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
45110|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
45111|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
45112|NCT02126839|E2|Reported Event|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
45113|NCT02126839|E1|Reported Event|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
45114|NCT02126748|B4|Baseline|Total|Total of all reporting groups
45115|NCT02126748|B3|Baseline|Control|20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day
45116|NCT02126748|B2|Baseline|Assisted Autogenic Drainage|20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
45117|NCT02126748|B1|Baseline|Intrapulmonary Percussive Ventilation|20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
45118|NCT02126748|P3|Participant Flow|Control|20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
45119|NCT02126748|P2|Participant Flow|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
inhalation 4ml hypertonic saline 3% 3x/day
Assisted Autogenic Drainage"
45120|NCT02126748|P1|Participant Flow|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
inhalation 4ml hypertonic saline 3% 3x/day
Intrapulmonary Percussive Ventilation"
45122|NCT02126748|O2|Outcome|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
inhalation 4ml hypertonic saline 3% 3x/day
Assisted Autogenic Drainage"
45123|NCT02126748|O1|Outcome|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
inhalation 4ml hypertonic saline 3% 3x/day
Intrapulmonary Percussive Ventilation"
45126|NCT02126748|E1|Reported Event|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
inhalation 4ml hypertonic saline 3% 3x/day
Intrapulmonary Percussive Ventilation"
45127|NCT02126670|B5|Baseline|Total|Total of all reporting groups
45128|NCT02126670|B4|Baseline|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04"
45129|NCT02126670|B3|Baseline|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03"
45130|NCT02126670|B2|Baseline|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02"
45131|NCT02126670|B1|Baseline|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01"
45132|NCT02126670|P4|Participant Flow|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04"
45133|NCT02126670|P3|Participant Flow|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03"
45134|NCT02126670|P2|Participant Flow|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02"
45135|NCT02126670|P1|Participant Flow|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01"
45136|NCT02126670|O4|Outcome|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04"
45137|NCT02126670|O3|Outcome|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03"
45138|NCT02126670|O2|Outcome|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02"
45139|NCT02126670|O1|Outcome|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01"
45140|NCT02126670|O4|Outcome|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04"
45141|NCT02126670|O3|Outcome|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03"
45142|NCT02126670|O2|Outcome|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02"
45143|NCT02126670|O1|Outcome|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01"
45144|NCT02126670|E4|Reported Event|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04"
45145|NCT02126670|E3|Reported Event|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03"
45146|NCT02126670|E2|Reported Event|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02"
45147|NCT02126670|E1|Reported Event|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01"
45148|NCT02126319|B3|Baseline|Total|Total of all reporting groups
45149|NCT02126319|B2|Baseline|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45150|NCT02126319|B1|Baseline|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45151|NCT02126319|P2|Participant Flow|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45152|NCT02126319|P1|Participant Flow|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45153|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45154|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
45260|NCT02125604|E1|Reported Event|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45261|NCT02125292|B1|Baseline|All Participants|
45155|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45156|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
45157|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45158|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
45159|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45160|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
45161|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45162|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
45163|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45164|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45183|NCT02126306|E1|Reported Event|Placebo|"Placebo
Beta Glucosylceramide: Beta Glucosylceramide
placebo: placebo"
45184|NCT02125877|B3|Baseline|Total|Total of all reporting groups
47956|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
45165|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45166|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45167|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45168|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45169|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45170|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45171|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45172|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45173|NCT02126319|E2|Reported Event|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45174|NCT02126319|E1|Reported Event|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
45175|NCT02126306|B3|Baseline|Total|Total of all reporting groups
45176|NCT02126306|B2|Baseline|Beta Glucosylceramide|"Beta Glucosylceramide
Beta Glucosylceramide: Beta Glucosylceramide
placebo: placebo"
45177|NCT02126306|B1|Baseline|Placebo|"Placebo
Beta Glucosylceramide: Beta Glucosylceramide
placebo: placebo"
45178|NCT02126306|P2|Participant Flow|Beta Glucosylceramide|"Beta Glucosylceramide 7.5 mg
Beta Glucosylceramide: Beta Glucosylceramide
placebo: placebo"
45179|NCT02126306|P1|Participant Flow|Placebo|"Placebo
Beta Glucosylceramide: Beta Glucosylceramide
placebo: placebo"
45180|NCT02126306|O2|Outcome|Beta Glucosylceramide|"Beta Glucosylceramide
Beta Glucosylceramide: Beta Glucosylceramide
placebo: placebo NAS score"
45181|NCT02126306|O1|Outcome|Placebo|"Placebo
Beta Glucosylceramide: Beta Glucosylceramide
placebo: placebo NAS score"
45182|NCT02126306|E2|Reported Event|Beta Glucosylceramide|"Beta Glucosylceramide
Beta Glucosylceramide: Beta Glucosylceramide
placebo: placebo"
45185|NCT02125877|B2|Baseline|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45278|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45186|NCT02125877|B1|Baseline|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45187|NCT02125877|P2|Participant Flow|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45188|NCT02125877|P1|Participant Flow|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45189|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45190|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45191|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45192|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45193|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45194|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45195|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45196|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45197|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45198|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45199|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45200|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45201|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45202|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45203|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45257|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45204|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45205|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45206|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45207|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45208|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45209|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45210|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45211|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45212|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45213|NCT02125877|E2|Reported Event|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
45214|NCT02125877|E1|Reported Event|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
45215|NCT02125838|B3|Baseline|Total|Total of all reporting groups
45216|NCT02125838|B2|Baseline|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
45217|NCT02125838|B1|Baseline|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT"
45218|NCT02125838|P2|Participant Flow|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
45219|NCT02125838|P1|Participant Flow|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT"
45220|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
45221|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT"
45222|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
45223|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT"
45302|NCT02124603|O1|Outcome|Single Group|patients undergone cataract surgery
45303|NCT02124603|O1|Outcome|Single Group|Patients undergone cataract surgery
45224|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
45225|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT"
45226|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
45227|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT"
45228|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
45229|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT"
45230|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
45231|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT"
45232|NCT02125838|E2|Reported Event|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.
Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
45233|NCT02125838|E1|Reported Event|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
Endotracheal Tube: ETT"
45234|NCT02125734|B3|Baseline|Total|Total of all reporting groups
45235|NCT02125734|B2|Baseline|Treatment Sequence 2|Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
45236|NCT02125734|B1|Baseline|Treatment Sequence 1|QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
45237|NCT02125734|P2|Participant Flow|Treatment Sequence 2|Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
45238|NCT02125734|P1|Participant Flow|Treatment Sequence 1|QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
45239|NCT02125734|O2|Outcome|Tiotropium|
45240|NCT02125734|O1|Outcome|QVA149|
45241|NCT02125734|O2|Outcome|Tiotropium|
45242|NCT02125734|O1|Outcome|QVA149|
45243|NCT02125734|O2|Outcome|Tiotropium|
45244|NCT02125734|O1|Outcome|QVA149|
45245|NCT02125734|E2|Reported Event|Tiotropium|Tiotropium
45246|NCT02125734|E1|Reported Event|QVA149|QVA149
45247|NCT02125604|B1|Baseline|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45248|NCT02125604|P1|Participant Flow|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45249|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45250|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45251|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45252|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45253|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45254|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45255|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45256|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
45258|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
81079|NCT01895946|E2|Reported Event|Part B|Part B of the study
45262|NCT02125292|P6|Participant Flow|Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
45263|NCT02125292|P5|Participant Flow|Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
45264|NCT02125292|P4|Participant Flow|Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
45265|NCT02125292|P3|Participant Flow|Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
45266|NCT02125292|P2|Participant Flow|Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
45267|NCT02125292|P1|Participant Flow|Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
45268|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
45269|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
45270|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
45271|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
45272|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45273|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45274|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45275|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45276|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45277|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45304|NCT02124603|E1|Reported Event|Single Group|Patients to have to undergone cataract surgery
45305|NCT02124460|B3|Baseline|Total|Total of all reporting groups
45279|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45280|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45281|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45282|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45283|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45284|NCT02125292|E3|Reported Event|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45285|NCT02125292|E2|Reported Event|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45286|NCT02125292|E1|Reported Event|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
45287|NCT02124863|B1|Baseline|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding
Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
45288|NCT02124863|P1|Participant Flow|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding
Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
45289|NCT02124863|O2|Outcome|Control|mean number of refluxes during 20 min, 120 min after each meal
45290|NCT02124863|O1|Outcome|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding
Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
45291|NCT02124863|E2|Reported Event|Control|mean number of refluxes during 20 min, 120 min after each meal
45292|NCT02124863|E1|Reported Event|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding
Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
45293|NCT02124798|B1|Baseline|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
45294|NCT02124798|P1|Participant Flow|Total|Eligible participants self administered once weekly dose of 200 milligram per milliliter (mg/mL), of belimumab subcutaneously (SC) into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
45295|NCT02124798|O1|Outcome|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
45296|NCT02124798|O1|Outcome|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
45297|NCT02124798|O1|Outcome|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
45350|NCT02124161|B2|Baseline|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45298|NCT02124798|E1|Reported Event|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
45299|NCT02124603|B1|Baseline|Single Group|Consecutive patients scheduled for cataract surgery
45300|NCT02124603|P1|Participant Flow|Single Group|Patients undergone cataract surgery
45301|NCT02124603|O1|Outcome|Single Group|Patients undergone cataract surgery
45306|NCT02124460|B2|Baseline|Health Coaching|Arm: Experimental: Health Coaching The intervention for this study will consist of three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45307|NCT02124460|B1|Baseline|Enhanced Primary Care|"Arm: No Intervention: Enhanced Primary Care We will provide current best practice to the control arm. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45308|NCT02124460|P2|Participant Flow|Health Coaching|"The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program.
Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community.
Parents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study."
45309|NCT02124460|P1|Participant Flow|Enhanced Primary Care|"We will provide current best practice to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45310|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45311|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45312|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45313|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45314|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45315|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45316|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45317|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45318|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45411|NCT02123472|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
45319|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45320|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45391|NCT02124122|E2|Reported Event|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
Placebo: Placebo"
45321|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45322|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45323|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45324|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45325|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45326|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45327|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45328|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45329|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45330|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45331|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45332|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45333|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45334|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
45412|NCT02123472|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
45335|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45352|NCT02124161|P2|Participant Flow|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45336|NCT02124460|E2|Reported Event|Health Coaching|"The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program.
Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community.
Parents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study."
45337|NCT02124460|E1|Reported Event|Enhanced Primary Care|"We will provide current best practice to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
45338|NCT02124304|B3|Baseline|Total|Total of all reporting groups
45339|NCT02124304|B2|Baseline|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening
Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
45340|NCT02124304|B1|Baseline|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening
Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
45341|NCT02124304|P2|Participant Flow|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening
Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
45342|NCT02124304|P1|Participant Flow|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening
Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
45343|NCT02124304|O2|Outcome|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening
Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
45344|NCT02124304|O1|Outcome|Cervical Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening
Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
45345|NCT02124304|O2|Outcome|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening
Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
45346|NCT02124304|O1|Outcome|Cervical Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening
Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
45347|NCT02124304|E2|Reported Event|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening
Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
45348|NCT02124304|E1|Reported Event|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening
Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
45349|NCT02124161|B3|Baseline|Total|Total of all reporting groups
45351|NCT02124161|B1|Baseline|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45611|NCT02121483|P2|Participant Flow|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
45353|NCT02124161|P1|Participant Flow|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45354|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45355|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45356|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45357|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45358|NCT02124161|O1|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45359|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45360|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45361|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45362|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45363|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45364|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45365|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45366|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45367|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45368|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45369|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45370|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
47957|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
45371|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45372|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45373|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
45374|NCT02124161|E8|Reported Event|Placebo+QIV/13vPnC: at 6-Month Follow-up|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
45375|NCT02124161|E7|Reported Event|13vPnC+QIV/Placebo: at 6-Month Follow-up|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
45376|NCT02124161|E6|Reported Event|Placebo+QIV/13vPnC: After 13vPnC Vaccination|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
45377|NCT02124161|E5|Reported Event|13vPnC+QIV/Placebo: After 13vPnC Vaccination|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
45378|NCT02124161|E4|Reported Event|Placebo+QIV/13vPnC: After Vaccination 2|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
45379|NCT02124161|E3|Reported Event|13vPnC+QIV/Placebo: After Vaccination 2|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
45380|NCT02124161|E2|Reported Event|Placebo+QIV/13vPnC: After Vaccination 1|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were accessed from Vaccination 1 up to before Vaccination 2.
45381|NCT02124161|E1|Reported Event|13vPnC+QIV/Placebo: After Vaccination 1|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from Vaccination 1 up to before Vaccination 2.
45382|NCT02124122|B3|Baseline|Total|Total of all reporting groups
45383|NCT02124122|B2|Baseline|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
Placebo: Placebo"
45384|NCT02124122|B1|Baseline|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
Lactobacillus reuteri: Probiotic"
45385|NCT02124122|P2|Participant Flow|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
Placebo: Placebo"
45386|NCT02124122|P1|Participant Flow|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
Lactobacillus reuteri: Probiotic"
45387|NCT02124122|O2|Outcome|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
Placebo: Placebo"
45388|NCT02124122|O1|Outcome|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
Lactobacillus reuteri: Probiotic"
45389|NCT02124122|O2|Outcome|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
Placebo: Placebo"
45413|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
45414|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
45390|NCT02124122|O1|Outcome|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
Lactobacillus reuteri: Probiotic"
45421|NCT02123459|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
45392|NCT02124122|E1|Reported Event|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
Lactobacillus reuteri: Probiotic"
45393|NCT02124044|B3|Baseline|Total|Total of all reporting groups
45394|NCT02124044|B2|Baseline|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
45395|NCT02124044|B1|Baseline|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
45396|NCT02124044|P2|Participant Flow|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
45397|NCT02124044|P1|Participant Flow|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
45398|NCT02124044|O2|Outcome|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
45399|NCT02124044|O1|Outcome|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
45400|NCT02124044|E2|Reported Event|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
45401|NCT02124044|E1|Reported Event|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
45402|NCT02123745|B1|Baseline|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
45403|NCT02123745|P1|Participant Flow|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
45404|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
45405|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
45406|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
45407|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
45408|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
45409|NCT02123745|E1|Reported Event|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
45410|NCT02123472|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion)
45415|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
45417|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
45418|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
45419|NCT02123472|E2|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
45420|NCT02123472|E1|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
45422|NCT02123459|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
45423|NCT02123459|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
45424|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
45425|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
45426|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
45427|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
45428|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
45429|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
45430|NCT02123459|E2|Reported Event|Cephalexin (Test)|"Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
Cephalexin: Administered orally"
45431|NCT02123459|E1|Reported Event|Cephalexin (Reference)|"Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
Cephalexin: Administered orally"
45432|NCT02123446|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
45433|NCT02123446|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
45434|NCT02123446|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
45435|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
45436|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
45437|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
45438|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
45439|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
45440|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
45441|NCT02123446|E2|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
45442|NCT02123446|E1|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
45443|NCT02123017|B4|Baseline|Total|Total of all reporting groups
45444|NCT02123017|B3|Baseline|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
45445|NCT02123017|B2|Baseline|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
45446|NCT02123017|B1|Baseline|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
45447|NCT02123017|P3|Participant Flow|180 Grams Crystalline Lactulose|15 mg bisacodyl, plus 60 grams crystalline lactulose x 3 doses
45448|NCT02123017|P2|Participant Flow|135 Grams Crystalline Lactulose|15 mg bisacodyl, plus 45 grams crystalline lactulose x 3 doses
45449|NCT02123017|P1|Participant Flow|90 Grams Crystalline Lactulose|15 mg bisacodyl, plus 30 grams crystalline lactulose x 3 doses
45450|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
45451|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
45452|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
45453|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
45454|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
45455|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
45456|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
45457|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
45462|NCT02123017|E3|Reported Event|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
45463|NCT02123017|E2|Reported Event|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
45464|NCT02123017|E1|Reported Event|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
45465|NCT02122549|B1|Baseline|HWD1000|"Subjects using HWD1000
HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
45466|NCT02122549|P1|Participant Flow|HWD1000|"Subjects using HWD1000
HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
45467|NCT02122549|O1|Outcome|HWD1000|Subjects wearing the HWD 1000.
45468|NCT02122549|E1|Reported Event|HWD1000|"Subjects using HWD1000
HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
45469|NCT02122445|B1|Baseline|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape
Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
45470|NCT02122445|P1|Participant Flow|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape
Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
45471|NCT02122445|O1|Outcome|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape
Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
45472|NCT02122445|O1|Outcome|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape
Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
45473|NCT02122445|E1|Reported Event|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape
Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
45474|NCT02122406|B1|Baseline|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
45475|NCT02122406|P1|Participant Flow|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
45476|NCT02122406|O1|Outcome|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
45477|NCT02122406|E1|Reported Event|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
45478|NCT02121860|B5|Baseline|Total|Total of all reporting groups
45479|NCT02121860|B4|Baseline|Normal Hepatic Function|Medically healthy as determined by the investigator
45480|NCT02121860|B3|Baseline|Child-Pugh Class C|Severe Hepatic Impairment
45481|NCT02121860|B2|Baseline|Child-Pugh Class B|Moderate Hepatic Impairment
45482|NCT02121860|B1|Baseline|Child-Pugh Class A|Mild Hepatic Impairment
45483|NCT02121860|P4|Participant Flow|Child-Pugh Class C|Severe hepatic impairment
45484|NCT02121860|P3|Participant Flow|Child-Pugh Class B|Moderate hepatic impairment
45485|NCT02121860|P2|Participant Flow|Child-Pugh Class A|Mild hepatic impairment
45486|NCT02121860|P1|Participant Flow|Normal Hepatic Function|Medically healthy as determined by the investigator
45487|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
45488|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
45489|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
45490|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
45491|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
45492|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
45493|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
45494|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
45495|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
45496|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
45497|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
45498|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
45499|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
45500|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
45501|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
45502|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
45503|NCT02121860|E1|Reported Event|IDN-6556|Single 50 mg oral dose of IDN-6556
45504|NCT02121847|B1|Baseline|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45505|NCT02121847|P1|Participant Flow|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45506|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45507|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45508|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45509|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45510|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45511|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45512|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45513|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45608|NCT02121483|B2|Baseline|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
45514|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45515|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45516|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45517|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45518|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45519|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45520|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45521|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45522|NCT02121847|E1|Reported Event|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
45523|NCT02121795|B3|Baseline|Total|Total of all reporting groups
45524|NCT02121795|B2|Baseline|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
45525|NCT02121795|B1|Baseline|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
45526|NCT02121795|P2|Participant Flow|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
45527|NCT02121795|P1|Participant Flow|F/TAF + 3rd Agent|Emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks
45528|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
45529|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
45530|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
45531|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
45532|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
45533|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
45534|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
45535|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
45536|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
45537|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
45538|NCT02121795|E2|Reported Event|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
45539|NCT02121795|E1|Reported Event|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
45540|NCT02121535|B3|Baseline|Total|Total of all reporting groups
45541|NCT02121535|B2|Baseline|Sequence RTTR|Oral administration of study drugs in the following order: R (period 1) - T (period 2) - T (period 3) - R (period 4). T: telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily. The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period.
45604|NCT02121509|E2|Reported Event|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
47958|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
45542|NCT02121535|B1|Baseline|Sequence TRRT|"Oral administration of study drugs in the following order: T (period 1) - R(period 2) - R (period 3) - T (period 4).
T: telmisartan 80mg+amlodipine 5mg+ hydrochlorothiazide (HCTZ) 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg fixed dose combination (FDC) + HCTZ 12.5mg tablet , once daily.
The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
45609|NCT02121483|B1|Baseline|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
45610|NCT02121483|P3|Participant Flow|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
81080|NCT01895946|E1|Reported Event|Part A|Part A of the study
45543|NCT02121535|P2|Participant Flow|Sequence RTTR|"Oral administration of study drugs in the following order: R (period 1) - T (period 2) - T (period 3) - R (period 4).
T: telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily. The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
45544|NCT02121535|P1|Participant Flow|Sequence TRRT|"Oral administration of study drugs in the following order: T (period 1) - R(period 2) - R (period 3) - T (period 4).
T: telmisartan 80mg+amlodipine 5mg+ hydrochlorothiazide (HCTZ) 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg fixed dose combination (FDC) + HCTZ 12.5mg tablet , once daily.
The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
45545|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
45546|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
45547|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
45548|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
45549|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
45550|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
45551|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
45552|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
45553|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
45554|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
45555|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
45556|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
45557|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
45558|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
45559|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
45560|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
45561|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
45562|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
45563|NCT02121535|E3|Reported Event|Total (All Patients)|Total of all the participants analyzed
45564|NCT02121535|E2|Reported Event|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
45565|NCT02121535|E1|Reported Event|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
45566|NCT02121522|B1|Baseline|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
45567|NCT02121522|P1|Participant Flow|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
45568|NCT02121522|O1|Outcome|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
45569|NCT02121522|O1|Outcome|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
45570|NCT02121522|E1|Reported Event|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
45571|NCT02121509|B3|Baseline|Total|Total of all reporting groups
45572|NCT02121509|B2|Baseline|FDC 1500 Fed or L+M 1500 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.
FDC 1500 fed (T fed): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after after a high-fat, high-calorie meal.
L+M 1500 fed (R fed): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
45573|NCT02121509|B1|Baseline|FDC 1500 Fasted or L+M 1500 Fasted|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.
FDC 1500 fasted (T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
L+M 1500 fasted (R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
45574|NCT02121509|P4|Participant Flow|L+M 1500 Fed / FDC 1500 Fed|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
45690|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45575|NCT02121509|P3|Participant Flow|FDC 1500 Fed / L+M 1500 Fed|"Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
45576|NCT02121509|P2|Participant Flow|L+M 1500 Fasted / FDC 1500 Fasted|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
45577|NCT02121509|P1|Participant Flow|FDC 1500 Fasted / L+M 1500 Fasted|"Linagliptin+ Metformin extended release (XR) (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
45578|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
45579|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
45580|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
45581|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
45582|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
45583|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
45584|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
45585|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
45586|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
45587|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
45588|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
45589|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
45590|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
45591|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
45592|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
45593|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
45594|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
45595|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
45596|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
45597|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
45598|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
45599|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
45600|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
45601|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
45602|NCT02121509|E4|Reported Event|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
45603|NCT02121509|E3|Reported Event|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
47959|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
45605|NCT02121509|E1|Reported Event|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
45606|NCT02121483|B4|Baseline|Total|Total of all reporting groups
45607|NCT02121483|B3|Baseline|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
45612|NCT02121483|P1|Participant Flow|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
45613|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
45614|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
45615|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
45616|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
45617|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
45618|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
45619|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
45620|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
45621|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
45622|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
45623|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
45624|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
45625|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
45626|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
45627|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
45628|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
45629|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
45630|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
45631|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
45632|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
45633|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
45634|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
45635|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
45636|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
45637|NCT02121483|E3|Reported Event|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
45638|NCT02121483|E2|Reported Event|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
45639|NCT02121483|E1|Reported Event|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
45640|NCT02121210|B3|Baseline|Total|Total of all reporting groups
45641|NCT02121210|B2|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
45642|NCT02121210|B1|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w for 24 weeks.
45643|NCT02121210|P2|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
45644|NCT02121210|P1|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg subcutaneous (SC) injection q2w for 24 weeks
45645|NCT02121210|O2|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
45646|NCT02121210|O1|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w for 24 weeks.
45647|NCT02121210|O2|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
45648|NCT02121210|O1|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w for 24 weeks.
45649|NCT02121210|E2|Reported Event|Sarilumab 200mg q2w|Sarilumab 200 mg SC injection q2w for 24 weeks.
45650|NCT02121210|E1|Reported Event|Sarilumab 150mg q2w|Sarilumab 150 mg SC injection q2w for 24 weeks.
45651|NCT02121067|B1|Baseline|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum
Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
45652|NCT02121067|P1|Participant Flow|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum
Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
45691|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
77549|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
45653|NCT02121067|O1|Outcome|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum
Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
45654|NCT02121067|O1|Outcome|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum
Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled"
45655|NCT02121067|O1|Outcome|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum
Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled"
45698|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
82259|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
45656|NCT02121067|E1|Reported Event|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum
Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
45657|NCT02121041|B3|Baseline|Total|Total of all reporting groups
45658|NCT02121041|B2|Baseline|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.
Amlodipine: Amlodipine 5 mg or 10 mg
Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg
Losartan: Losartan 50 mg or 100 mg"
45659|NCT02121041|B1|Baseline|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
45660|NCT02121041|P2|Participant Flow|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.
Amlodipine: Amlodipine 5 mg or 10 mg
Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg
Losartan: Losartan 50 mg or 100 mg"
45661|NCT02121041|P1|Participant Flow|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
45662|NCT02121041|O2|Outcome|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.
Amlodipine: Amlodipine 5 mg or 10 mg
Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg
Losartan: Losartan 50 mg or 100 mg"
45663|NCT02121041|O1|Outcome|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
45664|NCT02121041|E2|Reported Event|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.
Amlodipine: Amlodipine 5 mg or 10 mg
Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg
Losartan: Losartan 50 mg or 100 mg"
45665|NCT02121041|E1|Reported Event|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
45666|NCT02120833|B3|Baseline|Total|Total of all reporting groups
45667|NCT02120833|B2|Baseline|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45668|NCT02120833|B1|Baseline|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45669|NCT02120833|P2|Participant Flow|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45670|NCT02120833|P1|Participant Flow|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45671|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45672|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45673|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45674|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45675|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45676|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45677|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45678|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45679|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45680|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45681|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45682|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45683|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45684|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45685|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45686|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45687|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45688|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45689|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45692|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45693|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45694|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45695|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45696|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45697|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
49496|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
45700|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45701|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45702|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45703|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45704|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45705|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45706|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45707|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45708|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45709|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45710|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45711|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45712|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45713|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45714|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45715|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45716|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45717|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45718|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45719|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45720|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45721|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45722|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45723|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45724|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45725|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45726|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45727|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45728|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45729|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45730|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45731|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45732|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45733|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45734|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45735|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45736|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45737|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45738|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45739|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45740|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45741|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45742|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45743|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45744|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45745|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45746|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45747|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45748|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45749|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45750|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45751|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45752|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45753|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45754|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45755|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45756|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45757|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45758|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45759|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45760|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45761|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45762|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45763|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45764|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45765|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45766|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45767|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45768|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45769|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45770|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45771|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45772|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45773|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45774|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45775|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45776|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45777|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45778|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45779|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45780|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45781|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45782|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45783|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45784|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45785|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45786|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45787|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45788|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45789|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45790|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45791|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45792|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45793|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45794|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45795|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45796|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45797|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45798|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45799|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45800|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45801|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45802|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45803|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45804|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45805|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45806|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45807|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45808|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45809|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45810|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45811|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45812|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45813|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45814|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45815|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45816|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45817|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45818|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45819|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45820|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45821|NCT02120833|E2|Reported Event|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
45822|NCT02120833|E1|Reported Event|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
45823|NCT02120664|B6|Baseline|Total|Total of all reporting groups
45824|NCT02120664|B5|Baseline|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
45825|NCT02120664|B4|Baseline|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
45826|NCT02120664|B3|Baseline|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
45827|NCT02120664|B2|Baseline|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
45828|NCT02120664|B1|Baseline|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
45829|NCT02120664|P5|Participant Flow|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
45830|NCT02120664|P4|Participant Flow|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
45831|NCT02120664|P3|Participant Flow|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
45832|NCT02120664|P2|Participant Flow|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
45833|NCT02120664|P1|Participant Flow|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
45834|NCT02120664|O2|Outcome|Florbetapir SUVR Variability|Variability of standardized uptake value ratio (SUVR) for florbetapir scans in young healthy controls
45835|NCT02120664|O1|Outcome|PiB SUVR Variability|Variability of standardized uptake value ratio (SUVR) for PiB scans in young healthy controls
45836|NCT02120664|O5|Outcome|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
45837|NCT02120664|O4|Outcome|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
45838|NCT02120664|O3|Outcome|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
45839|NCT02120664|O2|Outcome|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
45840|NCT02120664|O1|Outcome|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
45841|NCT02120664|O5|Outcome|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
45842|NCT02120664|O4|Outcome|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
45843|NCT02120664|O3|Outcome|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
45844|NCT02120664|O2|Outcome|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
45845|NCT02120664|O1|Outcome|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
45846|NCT02120664|E4|Reported Event|Total|Events following Florbetapir (florbetapir only and both)
45847|NCT02120664|E3|Reported Event|Both|Events occurring within 48 hours of both florbetapir and PiB scans
45848|NCT02120664|E2|Reported Event|PiB Only|Events occurring within 48 hours of PiB scans only
45849|NCT02120664|E1|Reported Event|Florbetapir Only|Events occurring within 48 hours following florbetapir scans only
45850|NCT02120625|B1|Baseline|Baseline Demographics|
45851|NCT02120625|P1|Participant Flow|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
46676|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
45852|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
45853|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
45854|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
45855|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
48197|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
45856|NCT02120625|E1|Reported Event|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
45857|NCT02120443|B1|Baseline|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
45858|NCT02120443|P1|Participant Flow|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
45859|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
45860|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
45861|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
45862|NCT02120443|E1|Reported Event|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
45863|NCT02120417|B3|Baseline|Total|Total of all reporting groups
45864|NCT02120417|B2|Baseline|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45865|NCT02120417|B1|Baseline|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45866|NCT02120417|P2|Participant Flow|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45867|NCT02120417|P1|Participant Flow|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45868|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45869|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45870|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45871|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45872|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45873|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45874|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45875|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45876|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45877|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45878|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45879|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45880|NCT02120417|O2|Outcome|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45881|NCT02120417|O1|Outcome|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
82260|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
45882|NCT02120417|E2|Reported Event|Treatment B - Capecitabine and Placebo|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45883|NCT02120417|E1|Reported Event|Treatment A - Capecitabine and Ruxolitinib|Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
45884|NCT02120300|B5|Baseline|Total|Total of all reporting groups
45885|NCT02120300|B4|Baseline|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
45886|NCT02120300|B3|Baseline|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
45887|NCT02120300|B2|Baseline|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
45888|NCT02120300|B1|Baseline|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
45889|NCT02120300|P4|Participant Flow|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
45890|NCT02120300|P3|Participant Flow|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
45891|NCT02120300|P2|Participant Flow|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
45892|NCT02120300|P1|Participant Flow|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
45893|NCT02120300|O3|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
45894|NCT02120300|O2|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
45895|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
45896|NCT02120300|O3|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
45897|NCT02120300|O2|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
45898|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
45899|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
45900|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
45901|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
45902|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
45903|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
45904|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
45905|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
45906|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
45907|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
45908|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
45909|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
45910|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
45911|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
45912|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
45913|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
45914|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
45915|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
45916|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
45917|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
45918|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
45919|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
45920|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
45921|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
45922|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
45923|NCT02120300|E4|Reported Event|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
45924|NCT02120300|E3|Reported Event|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
45925|NCT02120300|E2|Reported Event|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
45926|NCT02120300|E1|Reported Event|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
45927|NCT02120027|B3|Baseline|Total|Total of all reporting groups
45928|NCT02120027|B2|Baseline|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
45929|NCT02120027|B1|Baseline|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .
Ibodutant 10 mg: Oral tablet, to be given once daily."
45930|NCT02120027|P2|Participant Flow|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.
Placebo: Oral tablet (identical in appearance and weight to ibodutant tablets) to be given once daily."
45931|NCT02120027|P1|Participant Flow|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .
Ibodutant 10 mg: Oral tablet, to be given once daily."
45932|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
45933|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .
Ibodutant 10 mg: Oral tablet, to be given once daily."
45934|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
45935|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .
Ibodutant 10 mg: Oral tablet, to be given once daily."
45936|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
45937|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .
Ibodutant 10 mg: Oral tablet, to be given once daily."
45938|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
45939|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .
Ibodutant 10 mg: Oral tablet, to be given once daily."
45940|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
45941|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .
Ibodutant 10 mg: Oral tablet, to be given once daily."
45942|NCT02120027|E2|Reported Event|Placebo for 24-week Treatment|"Oral tablet to be given once daily for 24 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
45943|NCT02120027|E1|Reported Event|Ibodutant 10 mg for 24-week Treatment|"Oral tablet to be given once daily for 24 weeks of treatment.
Ibodutant 10 mg: Oral tablet, to be given once daily."
45944|NCT02120001|B3|Baseline|Total|Total of all reporting groups
45945|NCT02120001|B2|Baseline|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
45946|NCT02120001|B1|Baseline|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
45947|NCT02120001|P2|Participant Flow|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
45948|NCT02120001|P1|Participant Flow|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
45949|NCT02120001|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
45950|NCT02120001|O1|Outcome|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
45951|NCT02120001|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
45952|NCT02120001|O1|Outcome|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
45953|NCT02120001|E2|Reported Event|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
45954|NCT02120001|E1|Reported Event|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
45955|NCT02119676|B5|Baseline|Total|Total of all reporting groups
45956|NCT02119676|B4|Baseline|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45957|NCT02119676|B3|Baseline|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45958|NCT02119676|B2|Baseline|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45959|NCT02119676|B1|Baseline|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45960|NCT02119676|P4|Participant Flow|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45961|NCT02119676|P3|Participant Flow|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45962|NCT02119676|P2|Participant Flow|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45963|NCT02119676|P1|Participant Flow|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg twice a day (BID) continuous with regorafenib 160 mg once daily (QD) for the first 21 days of each 28-day cycle.
45964|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45965|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45966|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45967|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45968|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45969|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45970|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45971|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45972|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45973|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45974|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45975|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45976|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45977|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45978|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45979|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45980|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
46677|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
45981|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45982|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45983|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45984|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45985|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
82261|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
45986|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45987|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45988|NCT02119676|E4|Reported Event|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45989|NCT02119676|E3|Reported Event|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45990|NCT02119676|E2|Reported Event|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45991|NCT02119676|E1|Reported Event|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
45992|NCT02119663|B3|Baseline|Total|Total of all reporting groups
45993|NCT02119663|B2|Baseline|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
45994|NCT02119663|B1|Baseline|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
45995|NCT02119663|P2|Participant Flow|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
45996|NCT02119663|P1|Participant Flow|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
45997|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
45998|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
45999|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46000|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46001|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46002|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46003|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46004|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46005|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46006|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46007|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46008|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46009|NCT02119663|E2|Reported Event|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46010|NCT02119663|E1|Reported Event|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46011|NCT02119650|B3|Baseline|Total|Total of all reporting groups
46012|NCT02119650|B2|Baseline|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46013|NCT02119650|B1|Baseline|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46014|NCT02119650|P2|Participant Flow|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46015|NCT02119650|P1|Participant Flow|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg twice daily (BID) oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46016|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46017|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46018|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46019|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46020|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46021|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46022|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46023|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46024|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46025|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46026|NCT02119650|E2|Reported Event|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46027|NCT02119650|E1|Reported Event|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
46028|NCT02119325|B1|Baseline|Overall Participants|
46029|NCT02119325|P2|Participant Flow|Sequence 2|Participants were administered with Placebo followed by Test. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46030|NCT02119325|P1|Participant Flow|Sequence 1|Participants were adminisetered with Test followed by Placebo. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46031|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46032|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46033|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46034|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46035|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46036|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
49497|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
46037|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46038|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46039|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46040|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46041|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46042|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46043|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46044|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46045|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46046|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46047|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46048|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46049|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46050|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46051|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46052|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46053|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46054|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46055|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46056|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46057|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46058|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46059|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water
46060|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46061|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46062|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46063|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46064|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46065|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46066|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46067|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46068|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
80223|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac
Ketorolac"
46069|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46070|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).
46071|NCT02119325|E2|Reported Event|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
46126|NCT02118896|B10|Baseline|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
46072|NCT02119325|E1|Reported Event|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
46073|NCT02119299|B1|Baseline|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
46074|NCT02119299|P1|Participant Flow|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
46075|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
46076|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
46077|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
46078|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
46079|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
46080|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
46081|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
46082|NCT02119299|O1|Outcome|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
46083|NCT02119299|E1|Reported Event|SMART Device|"Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device"
46084|NCT02119286|B4|Baseline|Total|Total of all reporting groups
46085|NCT02119286|B3|Baseline|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46086|NCT02119286|B2|Baseline|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46087|NCT02119286|B1|Baseline|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46088|NCT02119286|P3|Participant Flow|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46089|NCT02119286|P2|Participant Flow|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46090|NCT02119286|P1|Participant Flow|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46091|NCT02119286|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46092|NCT02119286|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46120|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46121|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
47960|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
46093|NCT02119286|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
82262|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
46094|NCT02119286|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46095|NCT02119286|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46096|NCT02119286|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46097|NCT02119286|E3|Reported Event|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46098|NCT02119286|E2|Reported Event|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46099|NCT02119286|E1|Reported Event|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
46100|NCT02119104|B1|Baseline|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
46101|NCT02119104|P1|Participant Flow|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
46102|NCT02119104|O1|Outcome|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
46103|NCT02119104|E1|Reported Event|Prevenar 13|Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
46104|NCT02118961|B3|Baseline|Total|Total of all reporting groups
46105|NCT02118961|B2|Baseline|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
46106|NCT02118961|B1|Baseline|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46107|NCT02118961|P2|Participant Flow|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
46108|NCT02118961|P1|Participant Flow|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46109|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
46110|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46111|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46112|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
46113|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46114|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46115|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
46116|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46117|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46118|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
46119|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46122|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46123|NCT02118961|E2|Reported Event|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
46124|NCT02118961|E1|Reported Event|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
46127|NCT02118896|B9|Baseline|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
46128|NCT02118896|B8|Baseline|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
46129|NCT02118896|B7|Baseline|PMR-EC-1105|"Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to"
46130|NCT02118896|B6|Baseline|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
46131|NCT02118896|B5|Baseline|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
46132|NCT02118896|B4|Baseline|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
46133|NCT02118896|B3|Baseline|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
46134|NCT02118896|B2|Baseline|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
46135|NCT02118896|B1|Baseline|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
46136|NCT02118896|P10|Participant Flow|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
46137|NCT02118896|P9|Participant Flow|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
46138|NCT02118896|P8|Participant Flow|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
46139|NCT02118896|P7|Participant Flow|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
46140|NCT02118896|P6|Participant Flow|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
46141|NCT02118896|P5|Participant Flow|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
46142|NCT02118896|P4|Participant Flow|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
46143|NCT02118896|P3|Participant Flow|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
46144|NCT02118896|P2|Participant Flow|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
46145|NCT02118896|P1|Participant Flow|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
46146|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
46147|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
46148|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
46149|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
46150|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
46151|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
46152|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
46153|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
46154|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
46155|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
46156|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
46157|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
46158|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
46159|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
46160|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
47961|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
46161|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
46162|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
46163|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
46164|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
46165|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
46166|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
46167|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
46168|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
46169|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
46170|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
46171|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
46172|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
46173|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
46174|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
46175|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
46176|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study. There were no reported BCAR in subjects in the previous study PMR-EC-1210, Kaplan-Meier estimate not applicable.
46177|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
46178|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
46179|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
46180|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
46181|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
46182|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
46183|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
46184|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
46185|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
46186|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
46187|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
46188|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
46189|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
46190|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
46191|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
46192|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
46193|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
46194|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
46195|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
46196|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
46197|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
46198|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
46199|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
46200|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
46201|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
46202|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
46203|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
46204|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
46205|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
46206|NCT02118896|E10|Reported Event|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
46207|NCT02118896|E9|Reported Event|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
46208|NCT02118896|E8|Reported Event|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
46209|NCT02118896|E7|Reported Event|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
46210|NCT02118896|E6|Reported Event|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
46211|NCT02118896|E5|Reported Event|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
46212|NCT02118896|E4|Reported Event|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
46213|NCT02118896|E3|Reported Event|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
46214|NCT02118896|E2|Reported Event|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
46215|NCT02118896|E1|Reported Event|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
46216|NCT02118831|B4|Baseline|Total|Total of all reporting groups
46217|NCT02118831|B3|Baseline|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
46218|NCT02118831|B2|Baseline|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
46219|NCT02118831|B1|Baseline|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
46220|NCT02118831|P3|Participant Flow|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
46221|NCT02118831|P2|Participant Flow|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
46222|NCT02118831|P1|Participant Flow|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
46223|NCT02118831|O3|Outcome|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
46224|NCT02118831|O2|Outcome|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
46225|NCT02118831|O1|Outcome|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
46226|NCT02118831|O3|Outcome|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
46227|NCT02118831|O2|Outcome|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
46228|NCT02118831|O1|Outcome|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
46229|NCT02118831|E3|Reported Event|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
46230|NCT02118831|E2|Reported Event|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
46231|NCT02118831|E1|Reported Event|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
46232|NCT02118792|B3|Baseline|Total|Total of all reporting groups
46233|NCT02118792|B2|Baseline|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46234|NCT02118792|B1|Baseline|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46367|NCT02117570|B1|Baseline|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46235|NCT02118792|P2|Participant Flow|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46236|NCT02118792|P1|Participant Flow|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable atopic dermatitis (AD)-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46237|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46238|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46239|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46240|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46241|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46242|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46243|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46244|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46245|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46246|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46247|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46248|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46249|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46250|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46251|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46252|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46253|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46254|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46255|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46256|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46257|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46258|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46259|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46260|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46261|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46262|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46263|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46264|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46265|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46266|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46267|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46268|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46269|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46270|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46271|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46272|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46273|NCT02118792|E2|Reported Event|AN2728 Topical Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46274|NCT02118792|E1|Reported Event|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
46275|NCT02118766|B3|Baseline|Total|Total of all reporting groups
46276|NCT02118766|B2|Baseline|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46277|NCT02118766|B1|Baseline|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46278|NCT02118766|P2|Participant Flow|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46279|NCT02118766|P1|Participant Flow|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46280|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46281|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46678|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46282|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46283|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46284|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46285|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46286|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46287|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46288|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46289|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46290|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46291|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46292|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46293|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46294|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46295|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46296|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46297|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46298|NCT02118766|E2|Reported Event|Crisaborole (AN2728) Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46299|NCT02118766|E1|Reported Event|Crisaborole (AN2728) Ointment, 2 Percent|Participants with mild to moderate AD applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
46300|NCT02118597|B1|Baseline|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46301|NCT02118597|P1|Participant Flow|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46302|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46303|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46304|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46305|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46362|NCT02117687|E2|Reported Event|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46306|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46365|NCT02117570|B3|Baseline|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46307|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46308|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46309|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46310|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46311|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46312|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
46313|NCT02118597|E1|Reported Event|Triple Combination Therapy|Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (Peg-interferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peg-interferon alfa-2a and ribavirin were observed.
46314|NCT02118441|B3|Baseline|Total|Total of all reporting groups
46315|NCT02118441|B2|Baseline|Ultrasound|"Radial artery catheter insertion will be conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer will be used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) will be used. Colour flow doppler may also be used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion"
46316|NCT02118441|B1|Baseline|Direct Palpation|"Radial artery catheter insertion will be conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion"
46317|NCT02118441|P2|Participant Flow|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion"
46318|NCT02118441|P1|Participant Flow|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion"
46319|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may also have been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion"
46320|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion"
46321|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion"
46322|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion"
46323|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion"
46324|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion"
46325|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion"
46326|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion"
46363|NCT02117687|E1|Reported Event|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46366|NCT02117570|B2|Baseline|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
49498|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
46327|NCT02118441|E2|Reported Event|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may also have been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion"
46328|NCT02118441|E1|Reported Event|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion"
46329|NCT02117687|B3|Baseline|Total|Total of all reporting groups
46330|NCT02117687|B2|Baseline|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46331|NCT02117687|B1|Baseline|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46332|NCT02117687|P2|Participant Flow|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46333|NCT02117687|P1|Participant Flow|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46334|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46335|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46336|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46337|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46338|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46339|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46340|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46341|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46342|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46343|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46344|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46345|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46346|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46347|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46348|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46349|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46350|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46351|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46352|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46353|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46354|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46355|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46356|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46357|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46358|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46359|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46360|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46361|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
46368|NCT02117570|P3|Participant Flow|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46369|NCT02117570|P2|Participant Flow|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46370|NCT02117570|P1|Participant Flow|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46371|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46372|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46373|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46374|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46375|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46376|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46377|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46378|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46379|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46380|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46381|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46382|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46383|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46384|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46385|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46386|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46387|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46388|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46389|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46390|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46391|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46392|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46393|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46394|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46395|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46396|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46397|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46398|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46399|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46400|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46401|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46402|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46403|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46404|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46405|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46406|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46407|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46408|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46409|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46410|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46411|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46412|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46413|NCT02117570|E6|Reported Event|Clostridium Difficile Vaccine, 200 µg (65-85 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46414|NCT02117570|E5|Reported Event|Clostridium Difficile Vaccine, 100 µg (65-85 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46415|NCT02117570|E4|Reported Event|Placebo (65-85 Year Age Cohort)|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46416|NCT02117570|E3|Reported Event|Clostridium Difficile Vaccine, 200 µg (50-64 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46417|NCT02117570|E2|Reported Event|Clostridium Difficile Vaccine, 100 µg (50-64 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46418|NCT02117570|E1|Reported Event|Placebo (50-64 Year Age Cohort)|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
46419|NCT02117544|B1|Baseline|Overall|AIR OPTIX® AQUA Multifocal and lotrafilcon B Multifocal (new design) contact lenses worn during Period 1 and Period 2 in a crossover assignment.
46420|NCT02117544|P2|Participant Flow|AOAMF, Then New MF|Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally for about 1 hour.
46421|NCT02117544|P1|Participant Flow|New MF, Then AOAMF|Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally for about 1 hour.
46422|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
46423|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
46424|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
46425|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
46426|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
46427|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
46428|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
46429|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
46430|NCT02117544|E3|Reported Event|AOAMF|Includes all subjects/eyes exposed to AOAMF
46431|NCT02117544|E2|Reported Event|New MF|Includes all subjects/eyes exposed to New MF
46432|NCT02117544|E1|Reported Event|Pre-treatment|Includes all enrolled subjects/eyes prior to exposure to the investigational products
46433|NCT02117479|B3|Baseline|Total|Total of all reporting groups
46434|NCT02117479|B2|Baseline|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46435|NCT02117479|B1|Baseline|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46436|NCT02117479|P2|Participant Flow|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46437|NCT02117479|P1|Participant Flow|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46438|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46439|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46440|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46441|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46442|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46443|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46444|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46445|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46446|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46447|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46448|NCT02117479|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46449|NCT02117479|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46450|NCT02117479|E2|Reported Event|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46451|NCT02117479|E1|Reported Event|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
46452|NCT02117414|B3|Baseline|Total|Total of all reporting groups
46453|NCT02117414|B2|Baseline|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour"
46454|NCT02117414|B1|Baseline|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
46455|NCT02117414|P2|Participant Flow|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour"
46456|NCT02117414|P1|Participant Flow|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
46457|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour"
46458|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
46459|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour"
46460|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
46461|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour"
46462|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
46463|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour"
46464|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
46465|NCT02117414|O1|Outcome|Implanted Subjects|All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis.
46466|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour"
46467|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
46468|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour"
46469|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
46470|NCT02117414|O1|Outcome|MRI Group|All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
80224|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen
IV ibuprofen"
46471|NCT02117414|E2|Reported Event|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour"
46472|NCT02117414|E1|Reported Event|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
49499|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
46473|NCT02117310|B1|Baseline|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
46474|NCT02117310|P1|Participant Flow|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
46475|NCT02117310|O1|Outcome|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
46476|NCT02117310|E1|Reported Event|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
46477|NCT02117193|B1|Baseline|All Study Participants|Received Alcohol intake + Normal Sleep Received Alcohol intake + Sleep Deprivation Received Placebo intake + Normal Sleep Received Placebo intake + Sleep Deprivation
46478|NCT02117193|P1|Participant Flow|All Study Participants|This is a cross-over study.
46479|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation
Placebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)"
46480|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep
Placebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.
Normal sleep: One night of normal sleep (8h)"
46481|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep Deprivation
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)"
46482|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Normal sleep: One night of normal sleep (8h)"
46483|NCT02117193|O4|Outcome|Placebo Intake + Sleep Deprivation|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation
46484|NCT02117193|O3|Outcome|Placebo Intake + Normal Sleep|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep
46485|NCT02117193|O2|Outcome|Alcohol Intake + Sleep Deprivation|1g/kg of alcohol (beer) combined with 8 hours of sleep deprivation
46486|NCT02117193|O1|Outcome|Alcohol Intake + Normal Sleep|1g/kg of alcohol (beer) combined with 8 hours of normal sleep
46487|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)"
46488|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Normal sleep: One night of normal sleep (8h)"
46489|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep deprivation
Alcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)"
46490|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep
Alcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.
Normal sleep: One night of normal sleep (8h)"
46491|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)"
46492|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Normal sleep: One night of normal sleep (8h)"
46493|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep deprivation
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)"
46494|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Normal sleep: One night of normal sleep (8h)"
46495|NCT02117193|E4|Reported Event|Placebo Intake + Sleep Deprivation|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation
46496|NCT02117193|E3|Reported Event|Placebo Intake + Normal Sleep|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep
46497|NCT02117193|E2|Reported Event|Alcohol Intake + Sleep Deprivation|1 g/kg of etanol combined with 8 hours of sleep deprivation
46498|NCT02117193|E1|Reported Event|Alcohol Intake + Normal Sleep|1 g/kg of etanol combined with 8 hours of normal sleep
46499|NCT02117050|B1|Baseline|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46500|NCT02117050|P1|Participant Flow|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46501|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46551|NCT02115815|B7|Baseline|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46502|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46540|NCT02116322|E1|Reported Event|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA
EUS-FNA with Corkscrew technique
Expect 19 G Flex needle"
46503|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46504|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46505|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46506|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46507|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46508|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46509|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46510|NCT02117050|E1|Reported Event|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
46519|NCT02116530|B3|Baseline|Total|Total of all reporting groups
46520|NCT02116530|B2|Baseline|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
placebo"
46521|NCT02116530|B1|Baseline|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
46522|NCT02116530|P2|Participant Flow|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
placebo"
46552|NCT02115815|B6|Baseline|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46631|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46523|NCT02116530|P1|Participant Flow|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
46524|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
placebo"
46525|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
46541|NCT02115984|B3|Baseline|Total|Total of all reporting groups
46564|NCT02115815|P1|Participant Flow|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46605|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46526|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
placebo"
46527|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
46528|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
placebo"
46529|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
46530|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
placebo"
46531|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
46532|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
placebo"
46533|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
46591|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46534|NCT02116530|E2|Reported Event|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
placebo"
46535|NCT02116530|E1|Reported Event|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
46536|NCT02116322|B1|Baseline|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA
EUS-FNA with Corkscrew technique
Expect 19 G Flex needle"
46537|NCT02116322|P1|Participant Flow|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA
EUS-FNA with Corkscrew technique
Expect 19 G Flex needle"
46538|NCT02116322|O1|Outcome|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA
EUS-FNA with Corkscrew technique
Expect 19 G Flex needle"
46539|NCT02116322|O1|Outcome|Pancreatic Mass|"Patients with pancreatic mass presenting for EUS-FNA
EUS-FNA with Corkscrew technique
Expect 19 G Flex needle"
46542|NCT02115984|B2|Baseline|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
46543|NCT02115984|B1|Baseline|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
46544|NCT02115984|P2|Participant Flow|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
46545|NCT02115984|P1|Participant Flow|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
46546|NCT02115984|O2|Outcome|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
46547|NCT02115984|O1|Outcome|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
46548|NCT02115984|E2|Reported Event|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
46549|NCT02115984|E1|Reported Event|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
46550|NCT02115815|B8|Baseline|Total|Total of all reporting groups
46592|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46553|NCT02115815|B5|Baseline|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46554|NCT02115815|B4|Baseline|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46555|NCT02115815|B3|Baseline|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46556|NCT02115815|B2|Baseline|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46557|NCT02115815|B1|Baseline|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46558|NCT02115815|P7|Participant Flow|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46559|NCT02115815|P6|Participant Flow|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46560|NCT02115815|P5|Participant Flow|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46561|NCT02115815|P4|Participant Flow|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46562|NCT02115815|P3|Participant Flow|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46563|NCT02115815|P2|Participant Flow|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
49500|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
46565|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46566|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46567|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46568|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46569|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46570|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46571|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46572|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46573|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46574|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46575|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46576|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46577|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46578|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46579|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46580|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46581|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46582|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46583|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46584|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46585|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46586|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46587|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46588|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46589|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46590|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46593|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46594|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46595|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46596|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46597|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46598|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46599|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46600|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46601|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46602|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46603|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46604|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46606|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46607|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46608|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46609|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46610|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46611|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46612|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46613|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46614|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46615|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46616|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46617|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46618|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46619|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46620|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46621|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46622|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46623|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46624|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46625|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46626|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46627|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46628|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46629|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46630|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46675|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46632|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46633|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46634|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46635|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46636|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46637|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46638|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46639|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46640|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46641|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46642|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46643|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46781|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
46644|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46645|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46646|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46647|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46648|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46649|NCT02115815|E7|Reported Event|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46650|NCT02115815|E6|Reported Event|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
46651|NCT02115815|E5|Reported Event|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46652|NCT02115815|E4|Reported Event|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
46653|NCT02115815|E3|Reported Event|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
46654|NCT02115815|E2|Reported Event|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
46655|NCT02115815|E1|Reported Event|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
46656|NCT02115581|B3|Baseline|Total|Total of all reporting groups
46657|NCT02115581|B2|Baseline|Placebo|known cases of idiopathic dilated cardiomyopathy who received the placebo
46658|NCT02115581|B1|Baseline|Conezyme Q10|known cases of idiopathic dilated cardiomyopathy who received Co Q10
46659|NCT02115581|P2|Participant Flow|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
46660|NCT02115581|P1|Participant Flow|Coenzyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
46661|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
46662|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
46663|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
46664|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
46665|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
46666|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
46667|NCT02115581|E2|Reported Event|Placebo (Control Group)|"Known cases of idiopathic dilated cardiomyopathy
Placebo: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient’s tolerance"
46668|NCT02115581|E1|Reported Event|Coenzyme Q10 (Study Group)|"Known cases of idiopathic dilated cardiomyopathy
Coenzyme Q10: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient’s tolerance"
46669|NCT02115321|B3|Baseline|Total|Total of all reporting groups
46670|NCT02115321|B2|Baseline|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46671|NCT02115321|B1|Baseline|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46672|NCT02115321|P2|Participant Flow|Part A: NC GZR 100 mg + EBR 50 mg|Non-cirrhotic (NC) participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46673|NCT02115321|P1|Participant Flow|Part A: CP-B GZR 50 mg + EBR 50 mg|Child-Pugh score 7 to 9 (CP-B) participants take GZR 50 mg + EBR 50 mg once daily (q.d.) by mouth for 12 weeks.
46674|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46679|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46680|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46681|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46682|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46683|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46684|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46685|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46686|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46687|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46688|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46689|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46690|NCT02115321|E2|Reported Event|Non-cirrhotic: GZR 100 mg + EBR 50 mg for 12 Weeks|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46691|NCT02115321|E1|Reported Event|CP-B: GZR 50 mg + EBR 50 mg for 12 Weeks|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
46692|NCT02115256|B3|Baseline|Total|Total of all reporting groups
46782|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
46693|NCT02115256|B2|Baseline|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
46694|NCT02115256|B1|Baseline|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
46695|NCT02115256|P2|Participant Flow|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
46696|NCT02115256|P1|Participant Flow|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
46697|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
46698|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
46699|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
46700|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
46701|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
46702|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
46703|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
46704|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
46705|NCT02115256|E2|Reported Event|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
80225|NCT01901393|E2|Reported Event|Ketorolac|"30mg ketorolac
Ketorolac"
46706|NCT02115256|E1|Reported Event|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
46707|NCT02114931|B3|Baseline|Total|Total of all reporting groups
46708|NCT02114931|B2|Baseline|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
46709|NCT02114931|B1|Baseline|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
46710|NCT02114931|P2|Participant Flow|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
46711|NCT02114931|P1|Participant Flow|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
46712|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
46713|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
46714|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
48199|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
46715|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
46716|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
46717|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
46718|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
46719|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
46720|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
46721|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
46722|NCT02114931|E2|Reported Event|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
46723|NCT02114931|E1|Reported Event|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
46724|NCT02114892|B3|Baseline|Total|Total of all reporting groups
46725|NCT02114892|B2|Baseline|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46726|NCT02114892|B1|Baseline|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46727|NCT02114892|P2|Participant Flow|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46728|NCT02114892|P1|Participant Flow|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46729|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46730|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46731|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46732|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46733|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46734|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46735|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46736|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46737|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46813|NCT02114268|O3|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
46738|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46739|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46740|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46741|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46742|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46743|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46744|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46783|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
46745|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46746|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46747|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46748|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46749|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46750|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46751|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46752|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46753|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46754|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46755|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46756|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46757|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46758|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46759|NCT02114892|E2|Reported Event|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
46760|NCT02114892|E1|Reported Event|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
46761|NCT02114268|B7|Baseline|Total|Total of all reporting groups
46762|NCT02114268|B6|Baseline|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
46763|NCT02114268|B5|Baseline|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
46764|NCT02114268|B4|Baseline|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
46765|NCT02114268|B3|Baseline|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
46766|NCT02114268|B2|Baseline|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
46767|NCT02114268|B1|Baseline|Placebo|Participants received placebo on Day 1.
46768|NCT02114268|P6|Participant Flow|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
46769|NCT02114268|P5|Participant Flow|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
46770|NCT02114268|P4|Participant Flow|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
46814|NCT02114268|O2|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
46771|NCT02114268|P3|Participant Flow|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
46772|NCT02114268|P2|Participant Flow|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
46773|NCT02114268|P1|Participant Flow|Placebo|Participants received placebo on Day 1.
46774|NCT02114268|O6|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
46775|NCT02114268|O5|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
46776|NCT02114268|O4|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
46777|NCT02114268|O3|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
46778|NCT02114268|O2|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
46779|NCT02114268|O1|Outcome|Placebo|Participants received placebo on Day 1.
46780|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
46784|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
46785|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
46786|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
46787|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
46788|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
46789|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
46790|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
46791|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
46792|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
46793|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
46794|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
46795|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
46796|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
46797|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
46798|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
46799|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
46800|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
46801|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
46802|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
46803|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
46804|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
46805|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
46806|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
46807|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
46808|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
46809|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
46810|NCT02114268|O6|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
46811|NCT02114268|O5|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
46812|NCT02114268|O4|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
46816|NCT02114268|E6|Reported Event|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
46817|NCT02114268|E5|Reported Event|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
46818|NCT02114268|E4|Reported Event|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
46819|NCT02114268|E3|Reported Event|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
46820|NCT02114268|E2|Reported Event|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
46821|NCT02114268|E1|Reported Event|Placebo|Participants received placebo on Day 1.
46822|NCT02114216|B4|Baseline|Total|Total of all reporting groups
46823|NCT02114216|B3|Baseline|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
46824|NCT02114216|B2|Baseline|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
46825|NCT02114216|B1|Baseline|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
46826|NCT02114216|P3|Participant Flow|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
46827|NCT02114216|P2|Participant Flow|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
47040|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
46828|NCT02114216|P1|Participant Flow|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
46829|NCT02114216|O3|Outcome|NERD Group|"Subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.
endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
46830|NCT02114216|O2|Outcome|ERD Group|"Subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.
endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
46831|NCT02114216|O1|Outcome|Control Group|"Subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.
endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
46832|NCT02114216|O3|Outcome|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
46833|NCT02114216|O2|Outcome|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
46834|NCT02114216|O1|Outcome|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
46835|NCT02114216|E3|Reported Event|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
46836|NCT02114216|E2|Reported Event|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
46837|NCT02114216|E1|Reported Event|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
46838|NCT02114177|B3|Baseline|Total|Total of all reporting groups
46839|NCT02114177|B2|Baseline|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46840|NCT02114177|B1|Baseline|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46841|NCT02114177|P2|Participant Flow|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46842|NCT02114177|P1|Participant Flow|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46843|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46844|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46845|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46846|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46847|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46848|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46849|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46850|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46851|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
47962|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
46852|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46853|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46854|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46855|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46856|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46857|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46858|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46859|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46860|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
82263|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
46861|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46862|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46863|NCT02114177|E2|Reported Event|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
46864|NCT02114177|E1|Reported Event|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
46865|NCT02114151|B1|Baseline|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46866|NCT02114151|P1|Participant Flow|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46867|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46868|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46869|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46870|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46871|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46872|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46873|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46874|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46875|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46876|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46877|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46878|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46879|NCT02114151|E1|Reported Event|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
46880|NCT02113579|B3|Baseline|Total|Total of all reporting groups
46881|NCT02113579|B2|Baseline|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46882|NCT02113579|B1|Baseline|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46883|NCT02113579|P2|Participant Flow|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46884|NCT02113579|P1|Participant Flow|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46885|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46886|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46887|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46888|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46889|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46890|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46891|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46892|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46893|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46895|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46896|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46897|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46898|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46899|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46900|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46901|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46902|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46903|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46904|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46905|NCT02113579|E2|Reported Event|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
46906|NCT02113579|E1|Reported Event|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
46907|NCT02113449|B1|Baseline|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
46936|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46908|NCT02113449|P1|Participant Flow|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
46909|NCT02113449|O1|Outcome|CO2 Nasal Spray|Score from 1 to 7 indicates how much or how little you think the statement applies to this product. A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it
46910|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
46911|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
46912|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
46913|NCT02113449|O1|Outcome|CO2 Nasal Spray|
46914|NCT02113449|O1|Outcome|C02 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
46915|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
46916|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
46917|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
46918|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
46919|NCT02113449|O1|Outcome|All Participants|"The participants were asked in the beginning which medication they purchase to relieve nasal congestion. Participant could select only one option available. If the participant answered I do not purchase any product to relieve congestion the participant was excluded. Participants could select only one option available."
46920|NCT02113449|E1|Reported Event|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
46921|NCT02113436|B3|Baseline|Total|Total of all reporting groups
46922|NCT02113436|B2|Baseline|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46923|NCT02113436|B1|Baseline|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46924|NCT02113436|P4|Participant Flow|FP/SLM 50/25 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP/SLM HFA MDI 50/25 μg in TP1.
46925|NCT02113436|P3|Participant Flow|FP HFA 50 µg - FP/SLM HFA 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg in TP1.
46926|NCT02113436|P2|Participant Flow|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46927|NCT02113436|P1|Participant Flow|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46928|NCT02113436|O2|Outcome|FP/SLM 50/25 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP/SLM HFA MDI 50/25 μg in TP1
46929|NCT02113436|O1|Outcome|FP 50 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg in TP1.
47963|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
46930|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46931|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46932|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46933|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46934|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46935|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
47041|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
46937|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46938|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46939|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46940|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46941|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46942|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46943|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46944|NCT02113436|E3|Reported Event|Period 2 - FP/SLM HFA 50/25 μg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg or FP/SLM HFA MDI 50/25 µg in TP1.
46945|NCT02113436|E2|Reported Event|Period 1 - FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46946|NCT02113436|E1|Reported Event|Period 1 - FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
46947|NCT02113124|B3|Baseline|Total|Total of all reporting groups
46948|NCT02113124|B2|Baseline|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
46949|NCT02113124|B1|Baseline|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
46950|NCT02113124|P2|Participant Flow|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
46951|NCT02113124|P1|Participant Flow|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
46952|NCT02113124|O2|Outcome|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
46953|NCT02113124|O1|Outcome|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
46954|NCT02113124|E2|Reported Event|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
46955|NCT02113124|E1|Reported Event|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
46956|NCT02113007|B1|Baseline|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5
Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
46957|NCT02113007|P1|Participant Flow|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5
Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
46958|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5
Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
47964|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
46959|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5
Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
46960|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5
Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
46961|NCT02113007|E1|Reported Event|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5
Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
46962|NCT02112448|B3|Baseline|Total|Total of all reporting groups
46991|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
46963|NCT02112448|B2|Baseline|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)
as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.
Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.
ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
46964|NCT02112448|B1|Baseline|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)
continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.
Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.
ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
46965|NCT02112448|P2|Participant Flow|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)
continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.
Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.
ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
46966|NCT02112448|P1|Participant Flow|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)
as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.
Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.
ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
46967|NCT02112448|O2|Outcome|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)
continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.
Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.
ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
46968|NCT02112448|O1|Outcome|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)
as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.
Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.
ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
46969|NCT02112448|O2|Outcome|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)
as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.
Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.
ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
46970|NCT02112448|O1|Outcome|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)
continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.
Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.
ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
47028|NCT02111083|B2|Baseline|Insulin Lispro Dosing Sequence RTRT|Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100 (reference [R] on 2 occasions). Subjects were randomly assigned to dosing sequences RTRT.
46971|NCT02112448|E2|Reported Event|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)
continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.
Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.
ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
46972|NCT02112448|E1|Reported Event|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)
as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.
Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.
ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
46973|NCT02112370|B3|Baseline|Total|Total of all reporting groups
47068|NCT02110238|O1|Outcome|Euflexxa|Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
46974|NCT02112370|B2|Baseline|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
46975|NCT02112370|B1|Baseline|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
46976|NCT02112370|P2|Participant Flow|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
46977|NCT02112370|P1|Participant Flow|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
46978|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
46979|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
46980|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
46981|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
46982|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
46983|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
46984|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
46985|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
46986|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
46987|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
47029|NCT02111083|B1|Baseline|Insulin Lispro Dosing Sequence TRTR|Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100(reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
47432|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
46988|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
46989|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
46990|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
47036|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
46992|NCT02112370|O2|Outcome|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
46993|NCT02112370|O1|Outcome|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
46994|NCT02112370|E2|Reported Event|Ropivacaine With Epinephrine Injection|"1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection."
46995|NCT02112370|E1|Reported Event|Normal Saline Injection|"100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection."
46996|NCT02111603|B1|Baseline|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
46997|NCT02111603|P1|Participant Flow|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
46998|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
46999|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
47000|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
47001|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
47002|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
47003|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
47004|NCT02111603|E1|Reported Event|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
47005|NCT02111369|B1|Baseline|Propranolol/Botulinum|After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
47006|NCT02111369|P1|Participant Flow|Propranolol/Botulinum|"After baseline analysis, patient will be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the patient had demonstrated no side effects. Dose may be increased to 240 mg each day depending on patient improvement and side effect profile. After second evaluation, patient will receive botulinum toxin injections. The risks and benefits of botulinum toxin therapy will be explained to the patient, and bilateral injections will take place.
Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
47007|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
47030|NCT02111083|P2|Participant Flow|Insulin Lispro Dosing Sequence RTRT|Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences RTRT.
47144|NCT02109172|P2|Participant Flow|Placebo First, Then 175mcg, Then 44mcg|Placebo twice daily for 7 days then 175mcg once daily for 7 days then 44mcg twice daily for 7 days
47008|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
47037|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
47038|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
47039|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
82385|NCT01889667|O3|Outcome|Placebo|"Oil Capsules
Placebo: Oil Capsules"
47009|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
47010|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
47011|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
47012|NCT02111369|E1|Reported Event|Propranolol/Botulinum|After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
47013|NCT02111252|B1|Baseline|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47014|NCT02111252|P1|Participant Flow|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47015|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47016|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47017|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47018|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47019|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47020|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47021|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47022|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47023|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47024|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47025|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47026|NCT02111252|E1|Reported Event|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
47027|NCT02111083|B3|Baseline|Total|Total of all reporting groups
47094|NCT02109497|B1|Baseline|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12
PBT2: PBT2 250 mg administered is Day 8 to 12."
47031|NCT02111083|P1|Participant Flow|Insulin Lispro Dosing Sequence TRTR|Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
47032|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
47033|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
47034|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
47035|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
47042|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
47043|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
47044|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
47045|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
47046|NCT02111083|E2|Reported Event|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
47047|NCT02111083|E1|Reported Event|Insulin Lispro A|Insulin Lispro A U-200 subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
47048|NCT02110381|B3|Baseline|Total|Total of all reporting groups
47049|NCT02110381|B2|Baseline|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
47050|NCT02110381|B1|Baseline|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
47051|NCT02110381|P2|Participant Flow|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
47052|NCT02110381|P1|Participant Flow|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
47095|NCT02109497|P1|Participant Flow|Caffeine Dosing|Single dose of caffeine 100 mg administered on Day 1 and Day 12 with PBT2 250 mg administered from Day 8 to 12.
47096|NCT02109497|O1|Outcome|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12
PBT2: PBT2 250 mg administered is Day 8 to 12."
47097|NCT02109497|O1|Outcome|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12
PBT2: PBT2 250 mg administered is Day 8 to 12."
85735|NCT01866163|E2|Reported Event|Vehicle|Aerosol foam vehicle
47053|NCT02110381|O2|Outcome|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
47054|NCT02110381|O1|Outcome|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
47069|NCT02110238|E2|Reported Event|Supartz|SUPARTZ® (hyaluronic acid of avian origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
47055|NCT02110381|O2|Outcome|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
47056|NCT02110381|O1|Outcome|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
47057|NCT02110381|O2|Outcome|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
47058|NCT02110381|O1|Outcome|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
47059|NCT02110381|E3|Reported Event|Screen Failures|These subjects reflect individuals who: 1) consented to be in the study, 2) participated in the initial run-in period to evaluate blood pressure, 3) ended up not meeting the blood pressure criteria required for randomization
47060|NCT02110381|E2|Reported Event|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
47098|NCT02109497|E1|Reported Event|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12
PBT2: PBT2 250 mg administered is Day 8 to 12."
47099|NCT02109458|B1|Baseline|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).
Navigation guided bronchoscopy"
47145|NCT02109172|P1|Participant Flow|Placebo First, Then 44mcg, Then 175mcg|Placebo twice daily for 7 days then 44mcg twice daily for 7 days then 175mcg once daily for 7 days
47061|NCT02110381|E1|Reported Event|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.
Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.
Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
47062|NCT02110238|B3|Baseline|Total|Total of all reporting groups
47063|NCT02110238|B2|Baseline|Supartz|SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
47064|NCT02110238|B1|Baseline|Euflexxa|Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
47065|NCT02110238|P2|Participant Flow|Supartz|"SUPARTZ® (hyaluronic acid of avian origin)
Supartz: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2."
47066|NCT02110238|P1|Participant Flow|Euflexxa|"Euflexxa® (hyaluronic acid of bacterial origin)
Euflexxa: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2."
47067|NCT02110238|O2|Outcome|Supartz|SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
47070|NCT02110238|E1|Reported Event|Euflexxa|Euflexxa® (hyaluronic acid of bacterial origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
47071|NCT02110147|B1|Baseline|Single Arm|All patients were treated with uridine triacetate oral granules.
47072|NCT02110147|P1|Participant Flow|Single Arm|All patients were treated with uridine triacetate oral granules.
47073|NCT02110147|O1|Outcome|Uridine Triacetate|All patients were treated with uridine triacetate oral granules.
47074|NCT02110147|O1|Outcome|Uridine Triacetate|All patients were treated with uridine triacetate oral granules.
47075|NCT02110147|O1|Outcome|Uridine Triacetate|All patients were treated with uridine triacetate oral granules.
47076|NCT02110147|E1|Reported Event|Single Arm|All patients were treated with uridine triacetate oral granules.
47077|NCT02109731|B1|Baseline|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.
Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
47078|NCT02109731|P1|Participant Flow|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.
Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
47079|NCT02109731|O1|Outcome|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.
Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
47080|NCT02109731|E1|Reported Event|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.
Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
47081|NCT02109640|B3|Baseline|Total|Total of all reporting groups
47082|NCT02109640|B2|Baseline|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy
Oxycodone: Postoperative analgesia
Laparoscopic segmental colectomy"
47083|NCT02109640|B1|Baseline|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy
Targinact: Post-operative analgesia
Laparoscopic segmental colectomy"
47084|NCT02109640|P2|Participant Flow|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy
Oxycodone: Postoperative analgesia
Laparoscopic segmental colectomy"
47085|NCT02109640|P1|Participant Flow|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy
Targinact: Post-operative analgesia
Laparoscopic segmental colectomy"
47086|NCT02109640|O2|Outcome|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy
Oxycodone: Postoperative analgesia
Laparoscopic segmental colectomy"
47087|NCT02109640|O1|Outcome|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy
Targinact: Post-operative analgesia
Laparoscopic segmental colectomy"
47088|NCT02109640|O2|Outcome|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy
Oxycodone: Postoperative analgesia
Laparoscopic segmental colectomy"
47089|NCT02109640|O1|Outcome|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy
Targinact: Post-operative analgesia
Laparoscopic segmental colectomy"
47090|NCT02109640|O2|Outcome|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy
Oxycodone: Postoperative analgesia
Laparoscopic segmental colectomy"
47091|NCT02109640|O1|Outcome|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy
Targinact: Post-operative analgesia
Laparoscopic segmental colectomy"
47092|NCT02109640|E2|Reported Event|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy
Oxycodone: Postoperative analgesia
Laparoscopic segmental colectomy"
47093|NCT02109640|E1|Reported Event|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy
Targinact: Post-operative analgesia
Laparoscopic segmental colectomy"
47965|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
47100|NCT02109458|P1|Participant Flow|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).
Navigation guided bronchoscopy"
47101|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).
Navigation guided bronchoscopy"
47102|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).
Navigation guided bronchoscopy"
47103|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).
Navigation guided bronchoscopy"
47104|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).
Navigation guided bronchoscopy"
47105|NCT02109458|E1|Reported Event|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).
Navigation guided bronchoscopy"
47156|NCT02109159|P1|Participant Flow|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.
A short online video with emotional content"
47106|NCT02109445|B1|Baseline|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47107|NCT02109445|P1|Participant Flow|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47108|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47109|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47110|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47111|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47112|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47113|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47114|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47141|NCT02109172|P5|Participant Flow|175mcg First, Then 44mcg, Then Placebo|175mcg once daily for 7 days then 44mcg twice daily for 7 days then placebo twice daily for 7 days
86567|NCT01859013|B3|Baseline|Total|Total of all reporting groups
47115|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47116|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47117|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47207|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
47118|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47119|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47120|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47121|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47122|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47123|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47124|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47125|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47126|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47142|NCT02109172|P4|Participant Flow|44mcg First, Then Placebo, Then 175mcg|44mcg twice daily for 7 days then placebo twice daily for 7 days then 175mcg once daily for 7 days
47143|NCT02109172|P3|Participant Flow|44mcg First, Then 175mcg, Then Placebo|44mcg twice daily for 7 days then 175mcg once daily for 7 days then placebo twice daily for 7 days
47127|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47128|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47129|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47130|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47131|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47132|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47133|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47134|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47135|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47136|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47137|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47138|NCT02109445|E1|Reported Event|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
47139|NCT02109172|B1|Baseline|Entire Study Population|All groups were randomized to receive placebo, TD-4208 44mcg twice daily, and TD-4208 175 mcg once daily
47140|NCT02109172|P6|Participant Flow|175mcg First, Then Placebo, Then 44mcg|175mcg once daily for 7 days then placebo twice daily for 7 days then 44mcg twice daily for 7 days
47146|NCT02109172|O3|Outcome|TD-4208 175 mcg Once Daily|"TD-4208 inhalation solution 175 mcg once daily, placebo once daily
TD-4208
Placebo"
47147|NCT02109172|O2|Outcome|TD-4208 44 mcg Twice Daily|"TD-4208 inhalation solution 44 mcg twice daily for 7 days
TD-4208"
47148|NCT02109172|O1|Outcome|Placebo|"Placebo inhalation solution twice daily for 7 days
Placebo"
47149|NCT02109172|E3|Reported Event|TD-4208 175mcg Once Daily|TD-4208 inhalation solution 175 mcg once daily
47150|NCT02109172|E2|Reported Event|TD-4208 44mcg Twice Daily|TD-4208 inhalation solution 44 mcg twice daily for 7 days
47151|NCT02109172|E1|Reported Event|Placebo|Placebo inhalation solution twice daily for 7 days
47152|NCT02109159|B3|Baseline|Total|Total of all reporting groups
47153|NCT02109159|B2|Baseline|Control Video|a short online video (2”43 minutes long) about the WOMAN trial with less emotional content (the interviewer provides a second hand description of the experience)
47154|NCT02109159|B1|Baseline|Emotional Video|a short online video (2”43 minutes long) about the WOMAN trial with more emotional content (an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience)
47155|NCT02109159|P2|Participant Flow|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.
A short online video with less emotional content"
48200|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
47157|NCT02109159|O2|Outcome|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.
A short online video with less emotional content"
47158|NCT02109159|O1|Outcome|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.
A short online video with emotional content"
47159|NCT02109159|O2|Outcome|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.
A short online video with less emotional content"
47160|NCT02109159|O1|Outcome|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.
A short online video with emotional content"
47161|NCT02109159|E2|Reported Event|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.
A short online video with less emotional content"
47162|NCT02109159|E1|Reported Event|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.
A short online video with emotional content"
47163|NCT02109133|B3|Baseline|Total|Total of all reporting groups
47164|NCT02109133|B2|Baseline|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex
Rocuronium
Sugammadex"
47165|NCT02109133|B1|Baseline|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine
Atracurium
Neostigmine"
47166|NCT02109133|P2|Participant Flow|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
47167|NCT02109133|P1|Participant Flow|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
47168|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
47169|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
47170|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
47171|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
47172|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex
Rocuronium
Sugammadex"
47173|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine
Atracurium
Neostigmine"
47196|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
47174|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
47175|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
47176|NCT02109133|E2|Reported Event|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex
Rocuronium
Sugammadex"
47177|NCT02109133|E1|Reported Event|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine
Atracurium
Neostigmine"
47178|NCT02109107|B1|Baseline|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
47208|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
47179|NCT02109107|P1|Participant Flow|Erchonia® Zerona 6 Headed Scanner (EZ6) Laser|"The Erchonia® Zerona 6 Headed Scanner (EZ6) Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
47180|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
47181|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
47182|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
47183|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
47184|NCT02109107|E1|Reported Event|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
47185|NCT02108977|B3|Baseline|Total|Total of all reporting groups
47186|NCT02108977|B2|Baseline|Telephone Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
47187|NCT02108977|B1|Baseline|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
47188|NCT02108977|P2|Participant Flow|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
47189|NCT02108977|P1|Participant Flow|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
47190|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
47191|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
47192|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
47193|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
47194|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
47195|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
47402|NCT02108171|E2|Reported Event|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47197|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
47198|NCT02108977|E2|Reported Event|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
47199|NCT02108977|E1|Reported Event|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
47200|NCT02108691|B3|Baseline|Total|Total of all reporting groups
47201|NCT02108691|B2|Baseline|Placebo|Placebo: Placebo (2.5g/day)
47202|NCT02108691|B1|Baseline|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
47203|NCT02108691|P2|Participant Flow|Placebo|Placebo: Placebo (2.5g/day)
47204|NCT02108691|P1|Participant Flow|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
47205|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
47206|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
47210|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
47211|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
47212|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
47213|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
47214|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
47215|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
47216|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
47217|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
47218|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
47219|NCT02108691|E2|Reported Event|Placebo|Placebo: Placebo (2.5g/day)
47220|NCT02108691|E1|Reported Event|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
47221|NCT02108652|B1|Baseline|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47222|NCT02108652|P1|Participant Flow|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47223|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47224|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47225|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47226|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47227|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47228|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47229|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47230|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47285|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
47231|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47232|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47233|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47234|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47235|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47408|NCT02107898|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) added to stable lipid-modifying therapy (LMT) for 52 weeks.
47236|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47237|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47238|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47239|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47240|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47241|NCT02108652|E1|Reported Event|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
47242|NCT02108288|B4|Baseline|Total|Total of all reporting groups
47243|NCT02108288|B3|Baseline|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47244|NCT02108288|B2|Baseline|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47245|NCT02108288|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47246|NCT02108288|P3|Participant Flow|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47247|NCT02108288|P2|Participant Flow|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47248|NCT02108288|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47249|NCT02108288|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47250|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47251|NCT02108288|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47252|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47253|NCT02108288|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47254|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47255|NCT02108288|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47256|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47257|NCT02108288|E3|Reported Event|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47258|NCT02108288|E2|Reported Event|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47259|NCT02108288|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47260|NCT02107196|B3|Baseline|Total|Total of all reporting groups
47261|NCT02107196|B2|Baseline|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
47262|NCT02107196|B1|Baseline|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.
Ibodutant 10 mg: Oral tablet, to be given once daily."
47286|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone"
90709|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
47263|NCT02107196|P2|Participant Flow|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomized to the placebo arm will be mock-re-randomized (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
47264|NCT02107196|P1|Participant Flow|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomized to the ibodutant 10 mg arm will be re-randomized at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.
Ibodutant 10 mg: Oral tablet, to be given once daily."
47265|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.
Ibodutant 10 mg: Oral tablet, to be given once daily."
47266|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
47267|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.
Ibodutant 10 mg: Oral tablet, to be given once daily."
49501|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
47268|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
47269|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.
Ibodutant 10 mg: Oral tablet, to be given once daily."
47270|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
47271|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.
Ibodutant 10 mg: Oral tablet, to be given once daily."
47272|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
47273|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.
Ibodutant 10 mg: Oral tablet, to be given once daily."
47274|NCT02107196|E2|Reported Event|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.
Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
47275|NCT02107196|E1|Reported Event|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.
Ibodutant 10 mg: Oral tablet, to be given once daily."
47276|NCT02108223|B4|Baseline|Total|Total of all reporting groups
47277|NCT02108223|B3|Baseline|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone"
47278|NCT02108223|B2|Baseline|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone"
47279|NCT02108223|B1|Baseline|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
47280|NCT02108223|P3|Participant Flow|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone"
47281|NCT02108223|P2|Participant Flow|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone"
47282|NCT02108223|P1|Participant Flow|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
47283|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone"
47284|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone"
47287|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone"
47288|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
47289|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone"
47290|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone"
47496|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47291|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
47292|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone"
47293|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone"
47294|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
47295|NCT02108223|O3|Outcome|r-FSH (Gonal-f) Group 3|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone"
47296|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH Group 2|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone"
47297|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f) Group 1|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
47298|NCT02108223|E3|Reported Event|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone"
47299|NCT02108223|E2|Reported Event|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone"
47300|NCT02108223|E1|Reported Event|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
47301|NCT02108171|B3|Baseline|Total|Total of all reporting groups
47302|NCT02108171|B2|Baseline|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47303|NCT02108171|B1|Baseline|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47304|NCT02108171|P2|Participant Flow|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47305|NCT02108171|P1|Participant Flow|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47306|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47307|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47308|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47309|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47310|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47341|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47311|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47312|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47313|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47314|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47315|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47316|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
83977|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
47317|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47318|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47319|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47320|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47321|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47322|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47323|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47324|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47325|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47326|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47327|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47328|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47329|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47330|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47331|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47332|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47333|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47334|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47335|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47336|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47337|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47338|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47339|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47340|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47342|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47343|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47344|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47345|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47346|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47347|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47348|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47349|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47350|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47351|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47352|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47353|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47354|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47355|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47356|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47357|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47358|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47359|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47360|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47361|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47362|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47363|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47364|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47365|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47366|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47367|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47368|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47369|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47370|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47371|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
90779|NCT01836523|B5|Baseline|Total|Total of all reporting groups
47372|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47373|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47374|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47375|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47376|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47377|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47378|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47379|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47380|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47381|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47382|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47383|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47384|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47385|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47386|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47387|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47388|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47389|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47390|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47391|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47392|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47393|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47394|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47395|NCT02108171|O1|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47396|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47397|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47398|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47399|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47400|NCT02108171|O2|Outcome|Placebo|"intranasal saline
placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47401|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
90841|NCT01836471|E1|Reported Event|QAW039 450 mg qd|QAW039 450 mg qd
47403|NCT02108171|E1|Reported Event|Dexmedetomidine|"intranasal dexmedetomidine
Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
47404|NCT02107898|B3|Baseline|Total|Total of all reporting groups
47405|NCT02107898|B2|Baseline|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47406|NCT02107898|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47407|NCT02107898|P2|Participant Flow|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
48198|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
47409|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47410|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47411|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47412|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47413|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47414|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47415|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47416|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47417|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47418|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47419|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47420|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47421|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47422|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47423|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47424|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47425|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47426|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47427|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47428|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47429|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47430|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47431|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47966|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
47433|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47434|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47435|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47436|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47437|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47438|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47439|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47440|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47441|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47442|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47443|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47444|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47445|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47446|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47447|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47448|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47449|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47450|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47451|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47452|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47453|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47454|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47455|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
47456|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
47457|NCT02107898|E2|Reported Event|Alirocumab 75 mg/ Up to 150 mg Q2W|Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 50 weeks).
47458|NCT02107898|E1|Reported Event|Placebo Q2W|Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 50 weeks).
47459|NCT02107599|B1|Baseline|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
47460|NCT02107599|P1|Participant Flow|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
47461|NCT02107599|O3|Outcome|Non-autopsy Cases|Only 50 non-autopsy scans from A17.
47462|NCT02107599|O2|Outcome|Autopsy Cases|Only 46 autopsy scans from A16.
47463|NCT02107599|O1|Outcome|All Study Cases|All 96 scans from A16 and A17.
47464|NCT02107599|O1|Outcome|Physician Readers|All 21 physician readers.
47465|NCT02107599|E1|Reported Event|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
47466|NCT02107482|B1|Baseline|All Participants - Levia Narrow Band UVB|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
47467|NCT02107482|P1|Participant Flow|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
47468|NCT02107482|O1|Outcome|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
47469|NCT02107482|O1|Outcome|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
47470|NCT02107482|O1|Outcome|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
47471|NCT02107482|E1|Reported Event|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
47472|NCT02107339|B3|Baseline|Total|Total of all reporting groups
47473|NCT02107339|B2|Baseline|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47474|NCT02107339|B1|Baseline|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47475|NCT02107339|P2|Participant Flow|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47476|NCT02107339|P1|Participant Flow|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47477|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47478|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47479|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47480|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47481|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47482|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47483|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47484|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47485|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47486|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47487|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47488|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
90842|NCT01836458|B5|Baseline|Total|Total of all reporting groups
47489|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47490|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47491|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47492|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47493|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47494|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47495|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47497|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47498|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47499|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47500|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47501|NCT02107339|E2|Reported Event|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure
Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
47502|NCT02107339|E1|Reported Event|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)
Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
47503|NCT02107313|B1|Baseline|All Study Participants|Participants are first administered PBT2 250 mg orally following a period of fasting for 10 hours and a high fat breakfast in the FED cohort. Participants then cross over into the FASTED Cohort and receive PBT2 250 mg orally after a period of fasting of 10 hours and without food.
47504|NCT02107313|P2|Participant Flow|Fasted Cohort First Then Fed Cohort|"Per sequence, FASTED Cohort first, then FED Cohort.
Nine participants in the Fasted Cohort. PBT2 250 mg is administered orally following a 10 hour period of fasting and without food first. Participants then cross over into the FED Cohort."
47505|NCT02107313|P1|Participant Flow|Fed Cohort First Then Fasted Cohort|"Per sequence, FED Cohort first then FASTED Cohort.
Nine participants in the FED Cohort. PBT2 250 mg is administered orally following a high fat breakfast first, following a period of fasting for 10 hours and a high fat breakfast. Participants then cross over into the FASTED Cohort."
47506|NCT02107313|O2|Outcome|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting
Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
47507|NCT02107313|O1|Outcome|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast
Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
47508|NCT02107313|O2|Outcome|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting
Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
47509|NCT02107313|O1|Outcome|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast
Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
47510|NCT02107313|E2|Reported Event|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting
Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
47511|NCT02107313|E1|Reported Event|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast
Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
47512|NCT02107274|B3|Baseline|Total|Total of all reporting groups
47513|NCT02107274|B2|Baseline|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47514|NCT02107274|B1|Baseline|Azithromycin|Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47515|NCT02107274|P2|Participant Flow|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47516|NCT02107274|P1|Participant Flow|Azithromycin and Placebo for Azithromycin|Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47517|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47518|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
90843|NCT01836458|B4|Baseline|Dose 4: 15 mg|Single dose of KAE609 15 mg
47519|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47520|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47521|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47522|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47523|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47524|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47525|NCT02107274|E2|Reported Event|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
83978|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
47526|NCT02107274|E1|Reported Event|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
47527|NCT02107014|B1|Baseline|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47528|NCT02107014|P1|Participant Flow|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47529|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47530|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47531|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47532|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47533|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47534|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47535|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47536|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47537|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47538|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47967|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
47968|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
47539|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47540|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47541|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47618|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47542|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47543|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47544|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47545|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47546|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47547|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47548|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47549|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47550|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47551|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47552|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47553|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47554|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47609|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
47555|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47556|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47557|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47558|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47559|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47560|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47561|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47562|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47563|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47564|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47565|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47566|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47567|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47568|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47569|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47570|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47610|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47571|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47572|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47573|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47574|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47575|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47576|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47577|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47578|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47579|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47580|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47581|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47582|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47583|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47584|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47585|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47586|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47611|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
47587|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47588|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47589|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47590|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47591|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47592|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47593|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47594|NCT02107014|E1|Reported Event|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
47595|NCT02106923|B4|Baseline|Total|Total of all reporting groups
47596|NCT02106923|B3|Baseline|1500mg, Fasted|Patients orally administered either 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h
47597|NCT02106923|B2|Baseline|1000mg, Fed|Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal
47598|NCT02106923|B1|Baseline|1000mg, Fasted|Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg metformin (Met) XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h).
47599|NCT02106923|P6|Participant Flow|Empa+1500mg Glumetza / Empa+1500mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR followed by oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
47600|NCT02106923|P5|Participant Flow|Empa+1500mg Met FDC / Empa+1500mg Glumetza (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
47601|NCT02106923|P4|Participant Flow|Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
47602|NCT02106923|P3|Participant Flow|Empa+1000mg Met FDC / Empa+1000mg Glumetza (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
47603|NCT02106923|P2|Participant Flow|Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
47604|NCT02106923|P1|Participant Flow|Empa+1000mg Met FDC / Empa+1000mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin (Empa)/1000 mg metformin (Met) extended release (XR) fixed dose combination (FDC) followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h).
47605|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
47606|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47607|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
47608|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
47612|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47613|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
47614|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
47615|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
47616|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47617|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
47619|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
47620|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
47621|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
47622|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47623|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
47624|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47625|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
47626|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
47627|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
47628|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47629|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
47630|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47631|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
47632|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
47633|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
47634|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47635|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
47636|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47637|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
47638|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
47639|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
47640|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47641|NCT02106923|E6|Reported Event|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
47642|NCT02106923|E5|Reported Event|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47643|NCT02106923|E4|Reported Event|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
47644|NCT02106923|E3|Reported Event|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
47645|NCT02106923|E2|Reported Event|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
47646|NCT02106923|E1|Reported Event|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
47648|NCT02106728|B2|Baseline|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
47649|NCT02106728|B1|Baseline|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
47687|NCT02106403|P1|Participant Flow|Sequence 1|Prototype disinfectant spray was sprayed twice on first wound, followed by Reference product twice sprayed on the second wound and subsequently Negative control was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
47650|NCT02106728|P2|Participant Flow|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
47651|NCT02106728|P1|Participant Flow|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
47652|NCT02106728|O6|Outcome|Supportive Family Therapy (Approximately 10 WEEKS)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
47653|NCT02106728|O5|Outcome|Multi-Family Therapy (8WEEKS)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
47654|NCT02106728|O4|Outcome|Supportive Family Therapy (POST)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
47655|NCT02106728|O3|Outcome|Multi-Family Therapy (POST)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
47656|NCT02106728|O2|Outcome|Supportive Family Therapy (PRE)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
47657|NCT02106728|O1|Outcome|Multi-Family Therapy (PRE)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
47658|NCT02106728|O2|Outcome|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
47659|NCT02106728|O1|Outcome|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
47660|NCT02106728|O2|Outcome|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
47661|NCT02106728|O1|Outcome|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
47662|NCT02106728|E2|Reported Event|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
47663|NCT02106728|E1|Reported Event|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
47664|NCT02106494|B3|Baseline|Total|Total of all reporting groups
47665|NCT02106494|B2|Baseline|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV
Day 2 - Dexamethasone 8 mg PO QD
Days 3 and 4 - Dexamethasone 8 mg PO BID"
47666|NCT02106494|B1|Baseline|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV
Day 2 - Dexamethasone 8 mg PO QD
Days 3 and 4 - Dexamethasone 8 mg PO BID"
47667|NCT02106494|P2|Participant Flow|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV
Day 2 – Dexamethasone 8 mg PO QD
Days 3 and 4 – Dexamethasone 8 mg PO BID"
47668|NCT02106494|P1|Participant Flow|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV
Day 2 – Dexamethasone 8 mg PO QD
Days 3 and 4 – Dexamethasone 8 mg PO BID"
47669|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV
Day 2 – Dexamethasone 8 mg PO QD
Days 3 and 4 – Dexamethasone 8 mg PO BID"
47670|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV
Day 2 – Dexamethasone 8 mg PO QD
Days 3 and 4 – Dexamethasone 8 mg PO BID"
47671|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV
Day 2 – Dexamethasone 8 mg PO QD
Days 3 and 4 – Dexamethasone 8 mg PO BID"
47672|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV
Day 2 – Dexamethasone 8 mg PO QD
Days 3 and 4 – Dexamethasone 8 mg PO BID"
47673|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV
Day 2 – Dexamethasone 8 mg PO QD
Days 3 and 4 – Dexamethasone 8 mg PO BID"
47674|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV
Day 2 – Dexamethasone 8 mg PO QD
Days 3 and 4 – Dexamethasone 8 mg PO BID"
47675|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV
Day 2 – Dexamethasone 8 mg PO QD
Days 3 and 4 – Dexamethasone 8 mg PO BID"
47676|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV
Day 2 – Dexamethasone 8 mg PO QD
Days 3 and 4 – Dexamethasone 8 mg PO BID"
47677|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV
Day 2 - Dexamethasone 8 mg PO QD
Days 3 and 4 - Dexamethasone 8 mg PO BID"
47678|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV
Day 2 - Dexamethasone 8 mg PO QD
Days 3 and 4 - Dexamethasone 8 mg PO BID"
47679|NCT02106494|E2|Reported Event|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV
Day 2 - Dexamethasone 8 mg PO QD
Days 3 and 4 - Dexamethasone 8 mg PO BID"
47680|NCT02106494|E1|Reported Event|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV
Day 2 - Dexamethasone 8 mg PO QD
Days 3 and 4 - Dexamethasone 8 mg PO BID"
47681|NCT02106403|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics
47682|NCT02106403|P6|Participant Flow|Sequence 6|Negative control was sprayed twice on the first wound, followed by Reference product sprayed twice on the second wound and Prototype Disinfectant Spray twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
47683|NCT02106403|P5|Participant Flow|Sequence 5|Negative control was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Reference product sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
47969|NCT02105012|E5|Reported Event|Placebo MDI|Placebo MDI.
47684|NCT02106403|P4|Participant Flow|Sequence 4|Reference product was sprayed twice on the first wound, followed by Negative control sprayed twice on the second wound and subsequently prototype disinfectant spray was twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
47685|NCT02106403|P3|Participant Flow|Sequence 3|Reference product was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Negative control sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
47686|NCT02106403|P2|Participant Flow|Sequence 2|Prototype disinfectant spray was sprayed twice on first wound, followed by Negative control sprayed twice on the second wound and subsequently Reference product was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
47688|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47689|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47690|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47691|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47692|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47693|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47694|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47695|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47696|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound
47697|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47698|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47699|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47700|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47701|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47702|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47703|NCT02106403|E3|Reported Event|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47704|NCT02106403|E2|Reported Event|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47705|NCT02106403|E1|Reported Event|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
47706|NCT02106156|B4|Baseline|Total|Total of all reporting groups
47707|NCT02106156|B3|Baseline|Elastography Analysis Set: Untreated|The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
47708|NCT02106156|B2|Baseline|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
47709|NCT02106156|B1|Baseline|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
47710|NCT02106156|P3|Participant Flow|Elastography Analysis Set: Untreated|The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
47711|NCT02106156|P2|Participant Flow|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with hepatitis C virus (HCV) treatment as indicated.
47712|NCT02106156|P1|Participant Flow|Main Analysis Set|Participants with chronic hepatitis C (CHC) treated with pegylated interferon (peginterferon) alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding summary of product characteristics (SmPC).
47970|NCT02105012|E4|Reported Event|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
47713|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
47714|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
47715|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
47716|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
47717|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
47718|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
47719|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
47720|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
47721|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
47722|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
47723|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
47724|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
47725|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
47726|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
47727|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
47728|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
47729|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
47730|NCT02106156|E3|Reported Event|Elastography Analysis Set: Untreated|Participants with CHC in the untreated elastography analysis set includes those participants, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
47731|NCT02106156|E2|Reported Event|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those, who were treated with HCV treatment as indicated.
47732|NCT02106156|E1|Reported Event|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
47733|NCT02105987|B3|Baseline|Total|Total of all reporting groups
47971|NCT02105012|E3|Reported Event|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
90844|NCT01836458|B3|Baseline|Dose 3: 10 mg|Single dose of KAE609 10 mg
47734|NCT02105987|B2|Baseline|Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47735|NCT02105987|B1|Baseline|Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47736|NCT02105987|P6|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch:Cont Phase|If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
47850|NCT02105688|P1|Participant Flow|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
83979|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
47737|NCT02105987|P5|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch:Cont Phase|If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
47738|NCT02105987|P4|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch|Participants who completed early switch phase and maintained viral suppression (<50 Copies per milliliter [c/mL]) were switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47739|NCT02105987|P3|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch|Participants who completed early switch phase continued to receive ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for an additional 24 weeks.
47740|NCT02105987|P2|Participant Flow|Current ART|Participants continued on their current ART regimen for 24 weeks.
47741|NCT02105987|P1|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received abacavir (ABC) 600 milligrams (mg)/ dolutegravir (DTG) 50 mg/ lamivudine (3TC) 300 mg fixed-dose combination (FDC) tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks.
47742|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47743|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47744|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47745|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47746|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47747|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47748|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47749|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47750|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47751|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47752|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47753|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47754|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47755|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47972|NCT02105012|E2|Reported Event|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
90845|NCT01836458|B2|Baseline|Dose 2: 20 mg|Single dose of KAE609 20 mg
47756|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47757|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47758|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
48081|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
47759|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47760|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47761|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47762|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47763|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47764|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47765|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47766|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47767|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47768|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47769|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47770|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47771|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47772|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47773|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47774|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47775|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47776|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47777|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47814|NCT02105740|O1|Outcome|Hypnosis|"Use of hypnosis to change the levels of pain.
Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms."
47778|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47779|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47780|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47781|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47782|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47783|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47784|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47785|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47786|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47787|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47788|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47789|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47790|NCT02105987|E2|Reported Event|Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
47791|NCT02105987|E1|Reported Event|Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
47792|NCT02105974|B3|Baseline|Total|Total of all reporting groups
47793|NCT02105974|B2|Baseline|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
47794|NCT02105974|B1|Baseline|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
47795|NCT02105974|P3|Participant Flow|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler [MDI] or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
47796|NCT02105974|P2|Participant Flow|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler [MDI] or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
47797|NCT02105974|P1|Participant Flow|Placebo Run-In|Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler [MDI] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.
47798|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
47845|NCT02105701|E1|Reported Event|GZR/EBR 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
47799|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
47800|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
48082|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
47801|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
47802|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
47803|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
47804|NCT02105974|E2|Reported Event|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
47805|NCT02105974|E1|Reported Event|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
47806|NCT02105740|B3|Baseline|Total|Total of all reporting groups
47807|NCT02105740|B2|Baseline|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales.
Control : The control and experimental groups respond in 3 different moments to Visual Analog Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting was made before the hypnosis. In the second meeting, within an interval of 7 days, the scales were applied in all patients. Before applying the scales, the hypnosis group was submitted to the session. The third meeting occurred two weeks later, where the scales were only applied to compare the groups."
47808|NCT02105740|B1|Baseline|Hypnosis|"Use of hypnosis to reduct the levels of pain, depression and anxiety.
Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
47809|NCT02105740|P2|Participant Flow|Control|"Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain, anxiety and depression with the application of the scales.
Control x Hypnosis Group: The control and hypnosis groups respond in 3 different distinct moments, with the Visual Analogue Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group, after the follow-up visit. The third evaluation will occur two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety."
47810|NCT02105740|P1|Participant Flow|Hypnosis|"Use of hypnosis in the reduction of the levels of pain, depression and anxiety.
Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression."
47811|NCT02105740|O2|Outcome|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding anxiety and depression with the application of the Hospital Anxiety and Depression Scale (HADS).
Control x Experimental Group: The control and experimental groups respond in 3 different distinct moments, with the Hospital Anxiety and Depression Scale (HADS) to evaluate depression and anxiety. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group was compared in relation to the intensity of the depression and anxiety"
47812|NCT02105740|O1|Outcome|Hypnosis|"Use of hypnosis in the reduction of the levels depression and anxiety.
Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
47813|NCT02105740|O2|Outcome|Control|"Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain with the application of the Visual Analogue Scale (VAS).
Control x Hypnosis Group: The control and the hypnosis groups respond in 3 different distinct moments, using the Visual Analogue Scale (VAS) to evaluate the pain. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was made two weeks later, in order to provide a follow-up to assess the efficacy of the technique."
47815|NCT02105740|E2|Reported Event|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales.
Control x Experimental Group: The control and experimental groups respond in 3 different distinct moments, with the Visual Analog Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation will be two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety"
47816|NCT02105740|E1|Reported Event|Hypnosis|"Use of hypnosis in the reduction of the levels of pain, depression and anxiety.
Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
47817|NCT02105701|B5|Baseline|Total|Total of all reporting groups
47818|NCT02105701|B4|Baseline|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
47819|NCT02105701|B3|Baseline|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
47820|NCT02105701|B2|Baseline|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
47821|NCT02105701|B1|Baseline|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
47822|NCT02105701|P4|Participant Flow|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
47823|NCT02105701|P3|Participant Flow|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
47824|NCT02105701|P2|Participant Flow|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
47825|NCT02105701|P1|Participant Flow|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
47826|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
47827|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
47828|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
47829|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
47830|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
47831|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
47832|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
47833|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
47834|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
47835|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
47836|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
47837|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
47838|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
47839|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
47840|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
47841|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
47842|NCT02105701|E4|Reported Event|GZR/EBR + RBV for 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
47843|NCT02105701|E3|Reported Event|GZR/EBR 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
47844|NCT02105701|E2|Reported Event|GZR/EBR + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
47846|NCT02105688|B3|Baseline|Total|Total of all reporting groups
47847|NCT02105688|B2|Baseline|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
47848|NCT02105688|B1|Baseline|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
47849|NCT02105688|P2|Participant Flow|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
83980|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
47851|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
47852|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
47853|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
47854|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
47855|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
47856|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
47857|NCT02105688|E2|Reported Event|Deferred Treatment Arm (Placebo)|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up.
47858|NCT02105688|E1|Reported Event|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
47859|NCT02105662|B1|Baseline|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
47860|NCT02105662|P1|Participant Flow|Grazoprevir+Elbasvir|Participants received a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
47861|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
47862|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
47863|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
47864|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
47865|NCT02105662|E1|Reported Event|Grazoprevir + Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
47866|NCT02105636|B3|Baseline|Total|Total of all reporting groups
47867|NCT02105636|B2|Baseline|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
47868|NCT02105636|B1|Baseline|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
47869|NCT02105636|P2|Participant Flow|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
47870|NCT02105636|P1|Participant Flow|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
47871|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigator's Choice.
47872|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
47896|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
47873|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
47874|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
48083|NCT02103309|E2|Reported Event|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
83981|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
47875|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
47876|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
47877|NCT02105636|E2|Reported Event|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
47878|NCT02105636|E1|Reported Event|Nivolumab 3 mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
47879|NCT02105467|B3|Baseline|Total|Total of all reporting groups
47880|NCT02105467|B2|Baseline|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
47881|NCT02105467|B1|Baseline|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
47882|NCT02105467|P2|Participant Flow|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks (Period 1), followed by a 4-week unblinding/washout period and 12 weeks of open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily (Period 2), followed by a 24-week follow-up period (Period 3).
47883|NCT02105467|P1|Participant Flow|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks (Period 1), followed by a 24-week follow-up period (Period 2)
47884|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
47885|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
47886|NCT02105467|O2|Outcome|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
47887|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
47888|NCT02105467|O2|Outcome|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
47889|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
47890|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
47891|NCT02105467|E3|Reported Event|Deferred Treatment Group (Open-label Treatment)|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Week 16 through Week 52.
47892|NCT02105467|E2|Reported Event|Deferred Treatment Group (Blinded Treatment)|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Day 1 through Week 16.
47893|NCT02105467|E1|Reported Event|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period. Adverse event reporting covers Day 1 through Week 36.
47894|NCT02105454|B1|Baseline|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
47895|NCT02105454|P1|Participant Flow|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
47953|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
47897|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
47898|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
47899|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
83982|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
47900|NCT02105454|E1|Reported Event|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
47901|NCT02105285|B4|Baseline|Total|Total of all reporting groups
47902|NCT02105285|B3|Baseline|Carteolol and Latanoprost Ophthalmic Solution|"Once daily
Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
47903|NCT02105285|B2|Baseline|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47904|NCT02105285|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47905|NCT02105285|P3|Participant Flow|Carteolol and Latanoprost Ophthalmic Solution|"Once daily
Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
47906|NCT02105285|P2|Participant Flow|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47907|NCT02105285|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47908|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47909|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47910|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47911|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47912|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47913|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47914|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47915|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47916|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47917|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47918|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47919|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47920|NCT02105285|E3|Reported Event|Carteolol and Latanoprost Ophthalmic Solution|"Once daily
Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
47921|NCT02105285|E2|Reported Event|Carteolol Long-acting Ophthalmic Solution|"Once daily
Carteolol long-acting ophthalmic solution"
47922|NCT02105285|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47923|NCT02105272|B3|Baseline|Total|Total of all reporting groups
47924|NCT02105272|B2|Baseline|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47925|NCT02105272|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47926|NCT02105272|P2|Participant Flow|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47927|NCT02105272|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47928|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47929|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47930|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47931|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47932|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47933|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47934|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47935|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47936|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47937|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47938|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47939|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47940|NCT02105272|E2|Reported Event|Latanoprost Ophthalmic Solution|"Once daily
Latanoprost ophthalmic solution"
47941|NCT02105272|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily
OPC-1085EL ophthalmic solution"
47942|NCT02105012|B1|Baseline|All Subjects|
47943|NCT02105012|P1|Participant Flow|All Subjects|
47944|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
47945|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
47946|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
47947|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
47948|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
47949|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
47950|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
47951|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
47952|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
47973|NCT02105012|E1|Reported Event|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
47974|NCT02104947|B3|Baseline|Total|Total of all reporting groups
47975|NCT02104947|B2|Baseline|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47976|NCT02104947|B1|Baseline|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47977|NCT02104947|P2|Participant Flow|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47978|NCT02104947|P1|Participant Flow|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47979|NCT02104947|O2|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47980|NCT02104947|O1|Outcome|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47981|NCT02104947|O1|Outcome|Idarucizumab (Group A & B)|"In Group A the patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
In Group B the patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes."
47982|NCT02104947|O2|Outcome|Non-ICH (Group A)|Group A patients with baseline non-intracranial hemorrhage (non-ICH).
47983|NCT02104947|O1|Outcome|ICH (Group A)|Group A patients with baseline intracranial hemorrhage (ICH).
47984|NCT02104947|O1|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47985|NCT02104947|O2|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47986|NCT02104947|O1|Outcome|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47987|NCT02104947|O2|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47988|NCT02104947|O1|Outcome|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47989|NCT02104947|O2|Outcome|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
90846|NCT01836458|B1|Baseline|Dose 1: 30 mg|Single dose of KAE609 30 mg
47990|NCT02104947|O1|Outcome|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
48084|NCT02103309|E1|Reported Event|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
48085|NCT02103114|B3|Baseline|Total|Total of all reporting groups
48086|NCT02103114|B2|Baseline|Placebo|Placebo: Normal saline placebo
47991|NCT02104947|E2|Reported Event|Idarucizumab (Group B)|Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47992|NCT02104947|E1|Reported Event|Idarucizumab (Group A)|Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
47993|NCT02104895|B3|Baseline|Total|Total of all reporting groups
47994|NCT02104895|B2|Baseline|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)
Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
47995|NCT02104895|B1|Baseline|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)
Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
47996|NCT02104895|P2|Participant Flow|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)
Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
47997|NCT02104895|P1|Participant Flow|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)
Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
47998|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)
Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
47999|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)
Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
48000|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)
Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
48001|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)
Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
48002|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)
Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
48003|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)
Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
48004|NCT02104895|E2|Reported Event|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)
Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
48005|NCT02104895|E1|Reported Event|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)
Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
48006|NCT02104830|B4|Baseline|Total|Total of all reporting groups
48007|NCT02104830|B3|Baseline|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml ubcutaneously, 24 h after the chemotherapy.
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
48008|NCT02104830|B2|Baseline|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
empegfilrastim 7.5 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml.
Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg."
48009|NCT02104830|B1|Baseline|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days
empegfilrastim 6 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48010|NCT02104830|P3|Participant Flow|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
48011|NCT02104830|P2|Participant Flow|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48077|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
48078|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
48012|NCT02104830|P1|Participant Flow|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48013|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
48014|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48015|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48016|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
48017|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48018|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48019|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
48020|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48021|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48022|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
48023|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48024|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48025|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
48026|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48027|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48028|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
48029|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48030|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48031|NCT02104830|E3|Reported Event|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
48032|NCT02104830|E2|Reported Event|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48033|NCT02104830|E1|Reported Event|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
48034|NCT02104219|B1|Baseline|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
48035|NCT02104219|P1|Participant Flow|Retrospective Observational|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
48036|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
48037|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
48038|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
48039|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
48040|NCT02104219|E1|Reported Event|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
48041|NCT02103855|B1|Baseline|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.
Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.
Belatacept"
48042|NCT02103855|P1|Participant Flow|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.
Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.
Belatacept"
48043|NCT02103855|O1|Outcome|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.
Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.
Belatacept"
48044|NCT02103855|O1|Outcome|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.
Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.
Belatacept"
48045|NCT02103855|O1|Outcome|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.
Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.
Belatacept"
48046|NCT02103855|O1|Outcome|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.
Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.
Belatacept"
48047|NCT02103855|O1|Outcome|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.
Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.
Belatacept"
48048|NCT02103855|E1|Reported Event|Belatacept|"Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.
Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.
Belatacept"
48049|NCT02103439|B3|Baseline|Total|Total of all reporting groups
48050|NCT02103439|B2|Baseline|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
48051|NCT02103439|B1|Baseline|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)
Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
48052|NCT02103439|P2|Participant Flow|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
48053|NCT02103439|P1|Participant Flow|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)
Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
48054|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
48055|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)
Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
48056|NCT02103439|O4|Outcome|PegIntron - HCV-2/3|"Patients with HCV genotype 2 or 3, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
48057|NCT02103439|O3|Outcome|PegIntron - HCV-1|"Patients with HCV genotype 1, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
48058|NCT02103439|O2|Outcome|Algeron - HCV-2/3|"Patients with HCV genotype 2 or 3, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)
Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
48059|NCT02103439|O1|Outcome|Algeron - HCV-1|"Patients with HCV genotype 1, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)
Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
48060|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
48061|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)
Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
48062|NCT02103439|O4|Outcome|PegIntron - HCV-2/3|"Patients with HCV genotype 2 or 3, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
48063|NCT02103439|O3|Outcome|PegIntron - HCV-1|"Patients with HCV genotype 1, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
48064|NCT02103439|O2|Outcome|Algeron - HCV-2/3|"Patients with HCV genotype 2 or 3, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)
Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
48065|NCT02103439|O1|Outcome|Algeron - HCV-1|"Patients with HCV genotype 1, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)
Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
48066|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
48067|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)
Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
48068|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
48069|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)
Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
48070|NCT02103439|E2|Reported Event|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).
PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week
The safety analysis included 71 patients received at least 1 dose of PegIntron (taking into account one patient withdrawn at early stages of the study due to a protocol violation [previous treatment of hepatitis C with interferon alfa], who was withdrawn from the mITT-analysis)"
48071|NCT02103439|E1|Reported Event|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)
Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
48072|NCT02103309|B1|Baseline|Overall|DAILIES® AquaComfort Plus® and 1-Day ACUVUE® MOIST® contact lenses worn in a crossover assignment.
48073|NCT02103309|P2|Participant Flow|1DAM, Then DACP|Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
48074|NCT02103309|P1|Participant Flow|DACP, Then 1DAM|Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
48075|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
48076|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
48079|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
48080|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
49502|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
48087|NCT02103114|B1|Baseline|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48088|NCT02103114|P2|Participant Flow|Placebo|Normal saline placebo
48089|NCT02103114|P1|Participant Flow|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48090|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48091|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48092|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48093|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48094|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48095|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48096|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48097|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48098|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48099|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48100|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48101|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48102|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48103|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48104|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48105|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48106|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
48107|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48108|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48109|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48110|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
48111|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48112|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48113|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48114|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
48115|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48116|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
48117|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48118|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48119|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48120|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48121|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48122|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48123|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48124|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48125|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48126|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
48127|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48128|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
48129|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48130|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48131|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48132|NCT02103114|O2|Outcome|Placebo|Placebo: Normal saline placebo
48133|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48134|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48135|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48136|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48137|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48138|NCT02103114|O2|Outcome|Placebo|Normal saline placebo
48139|NCT02103114|O1|Outcome|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48140|NCT02103114|E2|Reported Event|Placebo|Normal saline placebo
48141|NCT02103114|E1|Reported Event|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
* expressed as a % normal level based on functional ATIII assay"
48142|NCT02103062|B3|Baseline|Total|Total of all reporting groups
48143|NCT02103062|B2|Baseline|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48144|NCT02103062|B1|Baseline|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48145|NCT02103062|P2|Participant Flow|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48146|NCT02103062|P1|Participant Flow|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48147|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48148|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48149|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48150|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48151|NCT02103062|O2|Outcome|RAS Mutated Abraxane (Nab®-Paclitaxel)|Abraxane (nab®-paclitaxel) 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48152|NCT02103062|O1|Outcome|RAS Wildtype Abraxane (Nab®-Paclitaxel)|Abraxane (nab®-paclitaxel) 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48153|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48154|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48155|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48156|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48157|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48158|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48159|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
95527|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
48160|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48161|NCT02103062|E2|Reported Event|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48162|NCT02103062|E1|Reported Event|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
48163|NCT02102932|B9|Baseline|Total|Total of all reporting groups
48164|NCT02102932|B8|Baseline|R4T4|"Study Part 4:
R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4"
48165|NCT02102932|B7|Baseline|T4R4|"Study Part 4:
T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4."
48166|NCT02102932|B6|Baseline|R3T3|"Study Part 3:
R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3"
48167|NCT02102932|B5|Baseline|T3R3|"Study Part 3:
T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3."
48168|NCT02102932|B4|Baseline|R2T2|"Study part 2:
R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2."
48169|NCT02102932|B3|Baseline|T2R2|"Study Part 2:
T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2."
48170|NCT02102932|B2|Baseline|R1T1|"Study Part 1:
R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1."
48171|NCT02102932|B1|Baseline|T1R1|"Study Part 1:
T1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1."
48172|NCT02102932|P8|Participant Flow|R4T4|"Study Part 4:
R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4"
48173|NCT02102932|P7|Participant Flow|T4R4|"Study Part 4:
T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4."
48174|NCT02102932|P6|Participant Flow|R3T3|"Study Part 3:
R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3"
48175|NCT02102932|P5|Participant Flow|T3R3|"Study Part 3:
T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3."
48176|NCT02102932|P4|Participant Flow|R2T2|"Study part 2:
R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2."
48177|NCT02102932|P3|Participant Flow|T2R2|"Study Part 2:
T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2."
48178|NCT02102932|P2|Participant Flow|R1T1|"Study Part 1:
R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1."
48179|NCT02102932|P1|Participant Flow|T1R1|"Study Part 1:
T1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1."
48180|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
48181|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
48182|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
48183|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
48184|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
48185|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
48186|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
48187|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
48188|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
48189|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
48190|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
48191|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
48192|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
48193|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
48194|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
48195|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
48196|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
48201|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
48202|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
48203|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
48204|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
48205|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
48206|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
48207|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
48208|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
48209|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
48210|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
48211|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
48212|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
48213|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
48214|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
48215|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
48216|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
48217|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
48218|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
48219|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
48220|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
48221|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
48222|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
48223|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
48224|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
48225|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
48226|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
48227|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
48228|NCT02102932|E8|Reported Event|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
48229|NCT02102932|E7|Reported Event|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
48230|NCT02102932|E6|Reported Event|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
48231|NCT02102932|E5|Reported Event|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
48232|NCT02102932|E4|Reported Event|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
48233|NCT02102932|E3|Reported Event|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
48234|NCT02102932|E2|Reported Event|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
48235|NCT02102932|E1|Reported Event|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
48236|NCT02102399|B3|Baseline|Total|Total of all reporting groups
48237|NCT02102399|B2|Baseline|Respiratory Muscle Training|Respiratory Muscle Training group was performed during 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48238|NCT02102399|B1|Baseline|Vocal Warm-up|Vocal Warm up group was performed during 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48239|NCT02102399|P2|Participant Flow|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48240|NCT02102399|P1|Participant Flow|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48241|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48242|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
48243|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48244|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
49503|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
48245|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48246|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
48247|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
48248|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
48249|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
48250|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
48251|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
48252|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
48253|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
48254|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
48255|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
48256|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
48257|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
48258|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
48259|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48260|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48261|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48262|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48263|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48264|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48265|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48266|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48267|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48268|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48269|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48270|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48271|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48272|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48273|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48274|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48275|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48276|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
49239|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
48277|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48278|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48279|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48280|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
48281|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48282|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48283|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48284|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48285|NCT02102399|E2|Reported Event|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
48286|NCT02102399|E1|Reported Event|Vocal Warm-up|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
48287|NCT02101359|B3|Baseline|Total|Total of all reporting groups
48288|NCT02101359|B2|Baseline|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
48289|NCT02101359|B1|Baseline|T2380|T2380: Intracameral administration during surgery
48290|NCT02101359|P2|Participant Flow|Reference Group|Mydriatics and anesthetics: Topical treatments used the day of surgery
48291|NCT02101359|P1|Participant Flow|T2380|T2380: Intracameral administration during surgery
48292|NCT02101359|O2|Outcome|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
48293|NCT02101359|O1|Outcome|T2380|T2380: Intracameral administration during surgery
48294|NCT02101359|E2|Reported Event|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
48295|NCT02101359|E1|Reported Event|T2380|T2380: Intracameral administration during surgery
48296|NCT02101294|B1|Baseline|Interossei Lumbricals Neuro Interface|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.
48297|NCT02101294|P1|Participant Flow|Interossei Lumbricals Neuro Interface|"Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.
Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout [actual home row placement order: asdeihotlrn], plus substitutions on the upper row [qwfgjyuk;p] and bottom row [zxcvb'm,.] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness."
48298|NCT02101294|O1|Outcome|Measurement of Wrist Swelling Following FingerRelief|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the tape measurement of wrist swelling following typing with the FingerRelief keyboard.
48299|NCT02101294|O1|Outcome|Length of Time Typing With FingerRelief|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the FingerRelief keyboard prior to stopping, averaged across two typing sessions.
48338|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
48300|NCT02101294|O1|Outcome|Measurement of Wrist Swelling Following Typing With QWERTY|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the tape measurement of wrist swelling following typing with the QWERTY keyboard.
48301|NCT02101294|O1|Outcome|Length of Time Typing With QWERTY|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the QWERTY keyboard prior to stopping, averaged across two typing sessions.
48343|NCT02101112|E3|Reported Event|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
48344|NCT02101112|E2|Reported Event|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
49504|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
48302|NCT02101294|E1|Reported Event|Interossei Lumbricals Neuro Interface|"Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.
Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout [actual home row placement order: asdeihotlrn], plus substitutions on the upper row [qwfgjyuk;p] and bottom row [zxcvb'm,.] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness."
48303|NCT02101190|B3|Baseline|Total|Total of all reporting groups
48304|NCT02101190|B2|Baseline|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48305|NCT02101190|B1|Baseline|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48306|NCT02101190|P2|Participant Flow|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48307|NCT02101190|P1|Participant Flow|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48308|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48309|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48310|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48311|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48312|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48313|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48314|NCT02101190|E2|Reported Event|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48315|NCT02101190|E1|Reported Event|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC"
48316|NCT02101112|B1|Baseline|Apixaban, 10 mg (Whole Tablets)|This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
48317|NCT02101112|P6|Participant Flow|Treatment C Then Treatment B Then Treatment A|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
48318|NCT02101112|P5|Participant Flow|Treatment C Then Treatment A Then Treatment B|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
48339|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
48340|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
48341|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
48342|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
49487|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
48345|NCT02101112|E1|Reported Event|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
48346|NCT02101008|B1|Baseline|Disulfiram and Chelated Zinc|"There is only one arm. All patients are treated wtih disulfiram and chelated zinc.
disulfiram and chelated zinc"
48347|NCT02101008|P1|Participant Flow|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
48541|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
48319|NCT02101112|P4|Participant Flow|Treatment B Then Treatment A Then Treatment C|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
48320|NCT02101112|P3|Participant Flow|Treatment B Then Treatment C Then Treatment A|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
48321|NCT02101112|P2|Participant Flow|Treatment A Then Treatment C Then Treatment B|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
48322|NCT02101112|P1|Participant Flow|Treatment A Then Treatment B Then Treatment C|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
48323|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
48324|NCT02101112|O1|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
48325|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
48326|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
48327|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
48328|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
48329|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
48330|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
48331|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
48332|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
48333|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
48334|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
48335|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
48336|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
48337|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
48348|NCT02101008|O1|Outcome|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
48349|NCT02101008|O1|Outcome|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
48350|NCT02101008|E1|Reported Event|Disulfiram and Chelated Zinc|"There is only one arm. All patients are treated wtih disulfiram and chelated zinc.
disulfiram and chelated zinc"
48351|NCT02100839|B3|Baseline|Total|Total of all reporting groups
48352|NCT02100839|B2|Baseline|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.
Normal Saline: 0.9% saline for injection"
48353|NCT02100839|B1|Baseline|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.
AEM-28: Solution for injection"
48354|NCT02100839|P2|Participant Flow|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.
Normal Saline: 0.9% saline for injection"
48355|NCT02100839|P1|Participant Flow|Apolipoprotein E Mimetic (AEM)-28|"Single Ascending Dose (SAD): Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL
Multiple Ascending Dose (MAD): Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.
AEM-28: Solution for injection"
48356|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.
Normal Saline: 0.9% saline for injection"
48357|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.
AEM-28: Solution for injection"
48358|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.
Normal Saline: 0.9% saline for injection"
48359|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.
AEM-28: Solution for injection"
48360|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.
Normal Saline: 0.9% saline for injection"
48361|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.
AEM-28: Solution for injection"
48362|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.
Normal Saline: 0.9% saline for injection"
48363|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.
AEM-28: Solution for injection"
48364|NCT02100839|E2|Reported Event|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.
Normal Saline: 0.9% saline for injection"
48365|NCT02100839|E1|Reported Event|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.
AEM-28: Solution for injection"
48366|NCT02100826|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
48367|NCT02100826|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
48368|NCT02100826|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
48369|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
48370|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
48371|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
48372|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
48373|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
48374|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
48375|NCT02100826|E2|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
48376|NCT02100826|E1|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
48403|NCT02100514|B2|Baseline|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48404|NCT02100514|B1|Baseline|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48377|NCT02100644|B1|Baseline|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk
48378|NCT02100644|P3|Participant Flow|Maintenance Phase: LTG Plus VPA|Participants received two different treatments. In one group, participants received a fixed maintenance dose of LTG 200 mg/d (or 100 to 200 mg/d if there were safety concerns during the LTG Escalation Phase) and VPA 100 mg/d (or higher if seizures occurred during the VPA Reduction Phase) were administered twice and 1-3 times daily, respectively, for 12 weeks. The frequency of administration was not changed. If seizures occurred, VPA dose could be increased/re-introduced. On the other group, after VPA was withdrawn, LTG dose was escalated up to 300 mg/d with 50-100 mg increment per 1-2 weeks. If there was safety concern or if remaining dose to 300 mg/d was below 50 mg, 25 mg increment was also available. If seizures occurred, LTG dose was increased up to 400 mg/d. If there was safety concern, LTG dose was decreased to 100 mg/d. If there was still safety concern at 100 mg/d, the participants were discontinued from the study. The total duration of this phase was 12 weeks.
48379|NCT02100644|P2|Participant Flow|Reduction Phase: LTG Plus VPA|Participants received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was determined at the discretion of the investigator or sub-investigator: e.g., 1000 mg/d (2 weeks), 800 mg/d (2 weeks), 600 mg/d (2 weeks), 400 mg/d (2 weeks), 300 mg/d OR 1000 mg/d (4 weeks), 600 mg/d (4 weeks), 300 mg/d and when VPA was reduced to less than 300 mg/d, the dose was reduced to 300, 200, 100, and 0 mg/d in 100 mg decrements in steps of at least one week duration. When VPA was concomitantly used, LTG was administered twice daily with 200 mg/d as a maintenance dose. If there were safety concerns during the LTG Escalation Phase, a fixed maintenance dose of 100 to 200 mg/d of LTG was administered twice daily. When VPA was withdrawn (that is, VPA was reduced to 0 mg/d), LTG was required to be increased by 50-100 mg/d. If there were any safety concern, 25 mg increment was also available. The total duration of this phase was 4 to16 weeks.
48380|NCT02100644|P1|Participant Flow|Escalation Phase: LTG Plus VPA|Participants received a fixed maintenance dose of VPA (400-1200 mg/d) along with lamotrigine (LTG) which was gradually escalated to 200 mg/d in accordance with the information of package insert: i.e. 25 mg of LTG was orally administered once every other day for the first 2 weeks and then once daily for the following 2 weeks. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 weeks for once or twice daily administration. If there were safety concerns, the LTG dose was decreased to 100 mg/d at the discretion of the investigator or sub-investigator. If there were still safety concerns despite the dose reduction to 100 mg/d, LTG was discontinued. The total duration of this phase was 8 to18 weeks.
48381|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
48382|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
48383|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
48405|NCT02100514|P2|Participant Flow|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48406|NCT02100514|P1|Participant Flow|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48407|NCT02100514|O1|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48384|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
48385|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
48386|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
48387|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
48388|NCT02100644|E1|Reported Event|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to &lt; 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
48389|NCT02100579|B3|Baseline|Total|Total of all reporting groups
48390|NCT02100579|B2|Baseline|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline"
48391|NCT02100579|B1|Baseline|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine"
48392|NCT02100579|P2|Participant Flow|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline"
48393|NCT02100579|P1|Participant Flow|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine"
48394|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline"
48395|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine"
48396|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline"
48397|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine"
48398|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline"
48399|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine"
48400|NCT02100579|E2|Reported Event|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline"
48401|NCT02100579|E1|Reported Event|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine"
48408|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48409|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48410|NCT02100514|O1|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48411|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48412|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48413|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48414|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48415|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48416|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48417|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48418|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48419|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48420|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48421|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48422|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48423|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48424|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48425|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48426|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48427|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48428|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48429|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48430|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48431|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48432|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48433|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48434|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48435|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48436|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48437|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48438|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48439|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48440|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48441|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48442|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48443|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48444|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48445|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48446|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48447|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48448|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48449|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48450|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48451|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48452|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48453|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48454|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48455|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48456|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48457|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48458|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48459|NCT02100514|O2|Outcome|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48460|NCT02100514|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48461|NCT02100514|E2|Reported Event|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received PF­-04950615 150 mg subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48462|NCT02100514|E1|Reported Event|Placebo|Participants received placebo matched to Bococizumab (PF­-04950615) subcutaneous injection once in every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
48463|NCT02100475|B3|Baseline|Total|Total of all reporting groups
48464|NCT02100475|B2|Baseline|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48495|NCT02100410|E2|Reported Event|TEST (2,4,6)|Delefilcon A toric contact lenses without embossed mark, 3 different iterations, crossover all on the same eye
49108|NCT02095691|O1|Outcome|At 1 Month Follow up|Percentage of subjects achieving target SBP at 1 month follow up
48465|NCT02100475|B1|Baseline|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48466|NCT02100475|P2|Participant Flow|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48467|NCT02100475|P1|Participant Flow|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48468|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48469|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48470|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48471|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48472|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48473|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48474|NCT02100475|E2|Reported Event|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48475|NCT02100475|E1|Reported Event|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
48476|NCT02100410|B1|Baseline|Overall|All treatment sequences
48477|NCT02100410|P6|Participant Flow|Sequence 6|T5 and T6; T3 and T4; T1 and T2
48478|NCT02100410|P5|Participant Flow|Sequence 5|T5 and T6; T1 and T2; T3 and T4
48479|NCT02100410|P4|Participant Flow|Sequence 4|T3 and T4; T5 and T6; T1 and T2
48480|NCT02100410|P3|Participant Flow|Sequence 3|T3 and T4; T1 and T2; T5 and T6
48481|NCT02100410|P2|Participant Flow|Sequence 2|T1 and T2; T5 and T6; T3 and T4
48482|NCT02100410|P1|Participant Flow|Sequence 1|T1 and T2; T3 and T4; T5 and T6
48483|NCT02100410|O3|Outcome|TEST5|Iteration 2-87-3 with embossed mark
48484|NCT02100410|O2|Outcome|TEST3|Iteration 2-87-2 with embossed mark
48485|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
48486|NCT02100410|O6|Outcome|TEST6|Iteration 2-87-3 without embossed mark
48487|NCT02100410|O5|Outcome|TEST5|Iteration 2-87-3 with embossed mark
48488|NCT02100410|O4|Outcome|TEST4|Iteration 2-87-2 without embossed mark
48489|NCT02100410|O3|Outcome|TEST3|Iteration 2-87-2 with embossed mark
48490|NCT02100410|O2|Outcome|TEST2|Iteration 2-87-1 without embossed mark
48491|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
48496|NCT02100410|E1|Reported Event|TEST (1,3,5)|Delefilcon A toric contact lenses with embossed mark, 3 different iterations, crossover all on the same eye
48497|NCT02100189|B1|Baseline|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
48498|NCT02100189|P1|Participant Flow|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
48539|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
48499|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
48500|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
48501|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
48502|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
48503|NCT02100189|E1|Reported Event|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
48504|NCT02099838|B3|Baseline|Total|Total of all reporting groups
48505|NCT02099838|B2|Baseline|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48506|NCT02099838|B1|Baseline|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48507|NCT02099838|P2|Participant Flow|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48508|NCT02099838|P1|Participant Flow|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48509|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48510|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48511|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48512|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48513|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48514|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48515|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48516|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48517|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48518|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48540|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
48519|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48520|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48521|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48522|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48523|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48524|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48525|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48526|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48527|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48528|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48529|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48530|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48531|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48532|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48533|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48534|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48535|NCT02099838|E2|Reported Event|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
48800|NCT02097719|B2|Baseline|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
48536|NCT02099838|E1|Reported Event|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
48537|NCT02099708|B1|Baseline|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
48538|NCT02099708|P1|Participant Flow|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
48542|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
48543|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
48544|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
48545|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
48546|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
48547|NCT02099708|E1|Reported Event|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
48548|NCT02099682|B1|Baseline|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
48549|NCT02099682|P1|Participant Flow|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
48550|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
48551|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
48552|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
48553|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
48554|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
48555|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
48556|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
48557|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
48558|NCT02099682|E1|Reported Event|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
48559|NCT02099461|B4|Baseline|Total|Total of all reporting groups
48560|NCT02099461|B3|Baseline|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48561|NCT02099461|B2|Baseline|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48562|NCT02099461|B1|Baseline|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48563|NCT02099461|P3|Participant Flow|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48564|NCT02099461|P2|Participant Flow|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48565|NCT02099461|P1|Participant Flow|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48566|NCT02099461|O3|Outcome|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48567|NCT02099461|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48568|NCT02099461|O1|Outcome|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48569|NCT02099461|E3|Reported Event|Treatment C 120 MG SC|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48570|NCT02099461|E2|Reported Event|Treatment B 60 MG SC|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48571|NCT02099461|E1|Reported Event|Treatment A No Treatment|Participants in this group received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
48572|NCT02099344|B3|Baseline|Total|Total of all reporting groups
48573|NCT02099344|B2|Baseline|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access"
48574|NCT02099344|B1|Baseline|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access"
48575|NCT02099344|P2|Participant Flow|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access"
48801|NCT02097719|B1|Baseline|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
48576|NCT02099344|P1|Participant Flow|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access"
48577|NCT02099344|O2|Outcome|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access"
48578|NCT02099344|O1|Outcome|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access"
49505|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
48579|NCT02099344|E2|Reported Event|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access"
48580|NCT02099344|E1|Reported Event|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access"
48581|NCT02099318|B3|Baseline|Total|Total of all reporting groups
48582|NCT02099318|B2|Baseline|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.
Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
48583|NCT02099318|B1|Baseline|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during surgery for evaluation of optional surgery approaches.
Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches.
Inclusion criteria:
Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation f"
48584|NCT02099318|P2|Participant Flow|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.
Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
48585|NCT02099318|P1|Participant Flow|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.
Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
48586|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.
Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
48587|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.
Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
48588|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.
Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
48601|NCT02099266|O2|Outcome|Myeloablative Conditioning|"Myeloablative transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:
Day -10, -9, and -8: Fludarabine (25 mg/m2 IV) IV Day -7, -6, -5, and -4: Total body irradiation 165 cGy twice daily Day -3 and -2: Cyclophosphamide (60 mg/kg/day ) and mesna 50mg/kg/day (milligrams per kilogram per day) IV"
95528|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
48589|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.
Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
48604|NCT02099266|E1|Reported Event|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
48590|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.
Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
48591|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.
Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
48592|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.
Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
48593|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.
Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
48594|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.
Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
48595|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during surgery for evaluation of optional surgery approaches.
Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches.
Inclusion criteria:
Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation f"
48596|NCT02099318|E2|Reported Event|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.
Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
48597|NCT02099318|E1|Reported Event|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.
Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during surgery for evaluation of optional surgical approaches.
Inclusion criteria:
Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation for w"
48598|NCT02099266|B1|Baseline|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
48599|NCT02099266|P1|Participant Flow|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
48600|NCT02099266|O1|Outcome|Reduced-Intensity Conditioning|
95529|NCT01809106|E4|Reported Event|Fentanyl|Fentanyl: 25 microg/h
48602|NCT02099266|O1|Outcome|Reduced-Intensity Conditioning|"Reduced-Intensity (also referred to as: Non‐myeloablative) transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:
Day -6 : fludarabine 40mg/m2 (milligram per meter squared) intravenously (IV), cyclophosphamide 50mg/kg IV, and mesna 50mg/kg IV Day-5 to -2: fludarabine 40mg/m2 intravenously (IV) Day -1: Total body irradiation (TBI) 200 centrigray (cGy)"
48603|NCT02099266|O1|Outcome|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
48605|NCT02099084|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and Teduglutide first.
48606|NCT02099084|P2|Participant Flow|Placebo First, Then Teduglutide|Placebo administered subcutaneously for 7 days, followed by a 14-day washout period, and Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days.
48607|NCT02099084|P1|Participant Flow|Teduglutide First, Then Placebo|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days, followed by a 14-day washout period, and placebo administered subcutaneously for 7 days.
48608|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
48609|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
48610|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
48611|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
48612|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
48613|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
48614|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
48615|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
48616|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
48617|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
48618|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
48619|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
48620|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
48621|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
48622|NCT02099084|E2|Reported Event|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
48623|NCT02099084|E1|Reported Event|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
48624|NCT02099006|B1|Baseline|All Study Participants|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.
Amitriptyline/ Baclofen: Topical application of the drug at a 2% concentration in combination with 2% Baclofen
Ketoprofen: To be applied topically at a 10% concentration
Ketamine: To be applied topically at a 10% concentration
Loperamide: To be applied topically at a 5% concentration
Gabapentin: To be applied topically at a 6% concentration"
48625|NCT02099006|P1|Participant Flow|All Study Participants|"Each study subject was sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.
Amitriptyline 2%/ Baclofen 2%: Topical application of the drug at a 2% concentration in combination with 2% Baclofen
Ketoprofen: To be applied topically at a 10% concentration
Ketamine: To be applied topically at a 10% concentration
Loperamide: To be applied topically at a 5% concentration
Gabapentin: To be applied topically at a 6% concentration"
48626|NCT02099006|O2|Outcome|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.
placebo: Compounding base to be used alone as a placebo"
48627|NCT02099006|O1|Outcome|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.
Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen
Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline
Ketoprofen: To be applied topically at a 10% concentration
Ketamine: To be applied topically at a 10% concentration
Loperamide: To be applied topically at a 5% concentration
Gabapentin: To be applied topically at a 6% concentration"
48628|NCT02099006|O2|Outcome|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.
placebo: Compounding base to be used alone as a placebo"
48629|NCT02099006|O1|Outcome|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.
Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen
Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline
Ketoprofen: To be applied topically at a 10% concentration
Ketamine: To be applied topically at a 10% concentration
Loperamide: To be applied topically at a 5% concentration
Gabapentin: To be applied topically at a 6% concentration"
48802|NCT02097719|P2|Participant Flow|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
48630|NCT02099006|E2|Reported Event|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.
placebo: Compounding base to be used alone as a placebo"
48631|NCT02099006|E1|Reported Event|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.
Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen
Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline
Ketoprofen: To be applied topically at a 10% concentration
Ketamine: To be applied topically at a 10% concentration
Loperamide: To be applied topically at a 5% concentration
Gabapentin: To be applied topically at a 6% concentration"
48632|NCT02098746|B1|Baseline|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
48759|NCT02097823|B3|Baseline|Total|Total of all reporting groups
48633|NCT02098746|P1|Participant Flow|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
48634|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
48635|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
48636|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
48637|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
48638|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
48639|NCT02098746|E1|Reported Event|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
48640|NCT02098733|B1|Baseline|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
48641|NCT02098733|P1|Participant Flow|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
48642|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
48643|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
48644|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
48645|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
48646|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
48647|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
48648|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
48649|NCT02098733|E1|Reported Event|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
48650|NCT02098395|B5|Baseline|Total|Total of all reporting groups
48651|NCT02098395|B4|Baseline|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.
Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.
Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.
Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
48652|NCT02098395|B3|Baseline|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
48653|NCT02098395|B2|Baseline|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
48654|NCT02098395|B1|Baseline|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
48655|NCT02098395|P4|Participant Flow|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.
Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.
Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.
Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
48656|NCT02098395|P3|Participant Flow|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
48657|NCT02098395|P2|Participant Flow|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
48658|NCT02098395|P1|Participant Flow|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
48679|NCT02098304|O1|Outcome|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System
Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System"
48680|NCT02098304|O1|Outcome|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
48659|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.
Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.
Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.
Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
48660|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
83983|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
48661|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
48662|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
48663|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.
Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.
Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.
Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
48664|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
48665|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
48666|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
48667|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.
Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.
Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.
Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
48668|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
48669|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
48670|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
48671|NCT02098395|E4|Reported Event|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.
Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.
Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.
Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
48672|NCT02098395|E3|Reported Event|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
48673|NCT02098395|E2|Reported Event|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
48674|NCT02098395|E1|Reported Event|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
48675|NCT02098304|B1|Baseline|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging Device
Calcivis Caries Activity Imaging System: Unrestored sound molars and unsound molars imaged with the Calcivis Caries Activity Imaging System"
48676|NCT02098304|P1|Participant Flow|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System
48677|NCT02098304|O1|Outcome|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0), and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System
Calcivis Caries Activity Imaging System: Teeth imaged with the Calcivis Caries Activity Imaging System"
48678|NCT02098304|O1|Outcome|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
48729|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48681|NCT02098304|E1|Reported Event|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System
Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System"
48682|NCT02098109|B3|Baseline|Total|Total of all reporting groups
48683|NCT02098109|B2|Baseline|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
49506|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
48684|NCT02098109|B1|Baseline|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48685|NCT02098109|P2|Participant Flow|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48686|NCT02098109|P1|Participant Flow|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48687|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48688|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48689|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48690|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48691|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48692|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48693|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48694|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48695|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48696|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48697|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48698|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48699|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48700|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48701|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48702|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48703|NCT02098109|O2|Outcome|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48704|NCT02098109|O1|Outcome|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48705|NCT02098109|E2|Reported Event|Filgrastim (Neupogen) and Plerixafor|"Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48706|NCT02098109|E1|Reported Event|XM02 Filgrastim (Granix) and Plerixafor|"XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)"
48707|NCT02097992|B5|Baseline|Total|Total of all reporting groups
48708|NCT02097992|B4|Baseline|SD Roflumilast and MD Roflumilast Then MD Placebo|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily
48709|NCT02097992|B3|Baseline|SD Roflumilast and MD Placebo Then MD Roflumilast.|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
48710|NCT02097992|B2|Baseline|SD Placebo and MD Placebo Then MD Roflumilast|Participants will receive placebo (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
48711|NCT02097992|B1|Baseline|SD Placebo and MD Roflumilast Then MD Placebo|Participants will receive placebo (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily.
48712|NCT02097992|P4|Participant Flow|SD Roflumilast and MD Roflumilast Then MD Placebo|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily
48713|NCT02097992|P3|Participant Flow|SD Roflumilast and MD Placebo Then MD Roflumilast.|Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
48714|NCT02097992|P2|Participant Flow|SD Placebo and MD Placebo Then MD Roflumilast|Participants will receive placebo (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
48715|NCT02097992|P1|Participant Flow|SD Placebo and MD Roflumilast Then MD Placebo|Participants will receive placebo (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily.
48716|NCT02097992|O2|Outcome|Acute Roflumilast or Placebo|Treatment with a single dose of 500ug roflumilast or placebo
48717|NCT02097992|O1|Outcome|Long Term Multidose Roflumilast or Placebo|Treatment with 500ug roflumilast or placebo for 4 weeks
48718|NCT02097992|E2|Reported Event|Placebo|
48719|NCT02097992|E1|Reported Event|Roflumilast|
48720|NCT02097849|B3|Baseline|Total|Total of all reporting groups
48721|NCT02097849|B2|Baseline|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48722|NCT02097849|B1|Baseline|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48723|NCT02097849|P2|Participant Flow|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48724|NCT02097849|P1|Participant Flow|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48725|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48726|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48727|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48728|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48730|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48731|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48805|NCT02097719|O1|Outcome|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
48732|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48733|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48734|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48735|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48736|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48737|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48738|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48739|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48740|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48741|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48742|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48743|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48744|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48745|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48746|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48747|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48748|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48749|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48750|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48751|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48752|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48753|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48754|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48755|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48756|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48997|NCT02096705|E1|Reported Event|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
48757|NCT02097849|E2|Reported Event|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48758|NCT02097849|E1|Reported Event|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
48760|NCT02097823|B2|Baseline|Olanzapine First, Aprepitant Second|"Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.
Olanzapine dosing:
>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses
Aprepitant dosing:
>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses
Olanzapine
Aprepitant"
48761|NCT02097823|B1|Baseline|Aprepitant First, Olanzapine Second|"Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.
Olanzapine dosing:
>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses
Aprepitant dosing:
>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses
Olanzapine
Aprepitant"
48762|NCT02097823|P2|Participant Flow|Olanzapine First, Aprepitant Second|"Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.
Olanzapine dosing:
>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses
Aprepitant dosing:
>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses
Olanzapine
Aprepitant"
48763|NCT02097823|P1|Participant Flow|Aprepitant First, Olanzapine Second|"Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.
Olanzapine dosing:
>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses
Aprepitant dosing:
>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses
Olanzapine
Aprepitant"
48764|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48765|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48766|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48767|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48768|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48769|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48770|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48771|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48772|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48773|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48774|NCT02097823|O1|Outcome|All Participants|Both intervention arms included
48775|NCT02097823|E2|Reported Event|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48776|NCT02097823|E1|Reported Event|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
48777|NCT02097745|B1|Baseline|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48778|NCT02097745|P1|Participant Flow|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48779|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48780|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
49030|NCT02096575|P3|Participant Flow|Excluded|Participants that were withdrawn from the study after consent
48781|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48806|NCT02097719|E2|Reported Event|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
48782|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
48783|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48784|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
48785|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48786|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
48787|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48788|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
48789|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48790|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48791|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48792|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48793|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48794|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48795|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48796|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48797|NCT02097745|E2|Reported Event|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
48798|NCT02097745|E1|Reported Event|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
48799|NCT02097719|B3|Baseline|Total|Total of all reporting groups
49488|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
48803|NCT02097719|P1|Participant Flow|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
48804|NCT02097719|O2|Outcome|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
48807|NCT02097719|E1|Reported Event|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
48808|NCT02097537|B1|Baseline|Methacholine Chloride|"children with bronchial asthma
Methacholine Chloride (SK-1211)"
48809|NCT02097537|P1|Participant Flow|Methacholine Chloride|"children with bronchial asthma
Methacholine Chloride (SK-1211)"
48810|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma
Methacholine Chloride (SK-1211)"
48811|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma
Methacholine Chloride (SK-1211)"
48812|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma
Methacholine Chloride (SK-1211)"
48813|NCT02097537|E1|Reported Event|Methacholine Chloride|"children with bronchial asthma
Methacholine Chloride (SK-1211)"
48814|NCT02097108|B1|Baseline|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.
Raltegravir"
48815|NCT02097108|P1|Participant Flow|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.
Raltegravir"
48816|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.
Raltegravir"
48817|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.
Raltegravir"
48818|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.
Raltegravir"
48819|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.
Raltegravir"
48820|NCT02097108|E1|Reported Event|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.
Raltegravir"
48821|NCT02097056|B1|Baseline|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
48822|NCT02097056|P1|Participant Flow|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
48823|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
48824|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
48825|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
48826|NCT02097056|E1|Reported Event|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
48827|NCT02097030|B3|Baseline|Total|Total of all reporting groups
48828|NCT02097030|B2|Baseline|Nelfilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
nelfilcon A: contact lens filcon II 3: contact lens"
48829|NCT02097030|B1|Baseline|Etafilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
etafilcon A: contact lens filcon II 3: contact lens"
48830|NCT02097030|P2|Participant Flow|Nelfilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
nelfilcon A: contact lens filcon II 3: contact lens"
48831|NCT02097030|P1|Participant Flow|Etafilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
etafilcon A: contact lens filcon II 3: contact lens"
48832|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48833|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48834|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48835|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48836|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48837|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48838|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48839|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
97390|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
48840|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48841|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48842|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
49507|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
48843|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48844|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48845|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48846|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48847|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48848|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48849|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48850|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48851|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48852|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48853|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48854|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48855|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48856|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48857|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48858|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48859|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48860|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48861|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48862|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48863|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48864|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48865|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48866|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48867|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48868|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48869|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48870|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48871|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48872|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48873|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
49489|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
48874|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48875|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48876|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48877|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48878|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48879|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48880|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48881|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48882|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48883|NCT02097030|O2|Outcome|Filcon II 3|"Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A.
(hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)"
48884|NCT02097030|O1|Outcome|Hydrogel|"Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A.
(hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)"
48885|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48886|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48887|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48888|NCT02097030|E3|Reported Event|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48889|NCT02097030|E2|Reported Event|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48890|NCT02097030|E1|Reported Event|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
48891|NCT02096900|B3|Baseline|Total|Total of all reporting groups
48892|NCT02096900|B2|Baseline|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
48893|NCT02096900|B1|Baseline|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
48894|NCT02096900|P2|Participant Flow|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
48895|NCT02096900|P1|Participant Flow|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
48896|NCT02096900|O2|Outcome|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
48897|NCT02096900|O1|Outcome|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
48898|NCT02096900|O2|Outcome|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
48899|NCT02096900|O1|Outcome|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
48900|NCT02096900|O2|Outcome|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
48901|NCT02096900|O1|Outcome|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
48902|NCT02096900|O2|Outcome|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
48903|NCT02096900|O1|Outcome|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
48904|NCT02096900|O2|Outcome|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
48905|NCT02096900|O1|Outcome|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
48906|NCT02096900|E2|Reported Event|Zolpidem|zolpidem was given orally 0.25mg/kg pre-operatively single dose
48907|NCT02096900|E1|Reported Event|Midazolam|midazolam was given at 0.5mg/kg, pre-operatively single dose
48908|NCT02096835|B4|Baseline|Total|Total of all reporting groups
48909|NCT02096835|B3|Baseline|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction"
48910|NCT02096835|B2|Baseline|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction"
48911|NCT02096835|B1|Baseline|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction"
48912|NCT02096835|P3|Participant Flow|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction"
48963|NCT02096718|B2|Baseline|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
48913|NCT02096835|P2|Participant Flow|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction"
48914|NCT02096835|P1|Participant Flow|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction"
48915|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction"
48916|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction"
48917|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction"
48918|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction"
48919|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction"
48920|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction"
48921|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction"
48922|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction"
48923|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction"
48924|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction"
48925|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction"
48926|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction"
48927|NCT02096835|E3|Reported Event|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction"
48928|NCT02096835|E2|Reported Event|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction"
48929|NCT02096835|E1|Reported Event|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction"
48930|NCT02096744|B1|Baseline|Overall Study|"A randomised, double-blind, 2-way crossover design, followed by a period for assessment of adhesive properties of the clonidine patch.
In the crossover part of the trial, subjects were treated with either Catapres®-TTS delivering 0.3 mg clonidine/24 h (TTS-3) in the Oppanol® formulation (test treatment T1) or Catapres®-TTS-3 (0.3 mg/24 h) with Vistanex™ formulation (reference treatment R1) in each period. In the adhesion phase of the trial, subjects were treated simultaneously with Oppanol® (test treatment T2) and Vistanex™ (reference treatment R2) patches, each delivering 0.1 mg clonidine/24 h (TTS-1)."
48931|NCT02096744|P2|Participant Flow|Catapres®-TTS-3 Crossover 2: TTS-3 Vistanex Then TTS-3 Oppanol|Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Oppanol® (T1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h.
48932|NCT02096744|P1|Participant Flow|Catapres®-TTS-3 Crossover 1: TTS-3 Oppanol Then TTS-3 Vistanex|Catapres®-TTS(Transdermal Therapeutic System)-3 (0.3 mg/24 hr) Oppanol® (T1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h.
48933|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
48934|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
48935|NCT02096744|O2|Outcome|Catapres-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres-TTS-3 Vistanex™ (R1)
48936|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
48937|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
48938|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
48939|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
48940|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
48941|NCT02096744|E3|Reported Event|TTS-1: Vistanex™ (R2) + Oppanol® (T2)|Simultaneous administration of TTS-1 with Oppanol® and TTS-1 with Vistanex™
48942|NCT02096744|E2|Reported Event|TTS-3: Vistanex™ (R1)|Administration of TTS-3 with Vistanex™
48943|NCT02096744|E1|Reported Event|TTS-3: Oppanol® (T1)|Administration of TTS-3 with Oppanol®
48944|NCT02096731|B3|Baseline|Total|Total of all reporting groups
48945|NCT02096731|B2|Baseline|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
48946|NCT02096731|B1|Baseline|Tiotropium|Participants who were new users of tiotropium.
48947|NCT02096731|P2|Participant Flow|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
48948|NCT02096731|P1|Participant Flow|Tiotropium|Participants who were new users of tiotropium.
48949|NCT02096731|O2|Outcome|Combination Therapy|Participants who can be linked to the Hospital Episode Statistics database and who added another long-acting bronchodilator to the previous long-acting bronchodilator.
48950|NCT02096731|O1|Outcome|Monotherapy|Participants who can be linked to the Hospital Episode Statistics database and who remained on a single long- acting bronchodilator.
48951|NCT02096731|O2|Outcome|Combination Therapy|Participants who can be linked to the Hospital Episode Statistics database and who added another long-acting bronchodilator to the previous long-acting bronchodilator.
48952|NCT02096731|O1|Outcome|Monotherapy|Participants who can be linked to the Hospital Episode Statistics database and who remained on a single long-acting bronchodilator.
48953|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
48954|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
48955|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
48956|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
48957|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
48958|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
48959|NCT02096731|E2|Reported Event|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
48960|NCT02096731|E1|Reported Event|Tiotropium|Participants who were new users of tiotropium.
48961|NCT02096718|B4|Baseline|Total|Total of all reporting groups
49109|NCT02095691|O4|Outcome|Change in Blood Pressure at 12 Month Follow Up|Change in Blood Pressure from baseline to 12 months follow up
48962|NCT02096718|B3|Baseline|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
48964|NCT02096718|B1|Baseline|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
48965|NCT02096718|P3|Participant Flow|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
48966|NCT02096718|P2|Participant Flow|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
48967|NCT02096718|P1|Participant Flow|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
48968|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
48969|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
48970|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
48971|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
48972|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
48973|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
48974|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
48975|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
48976|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
48977|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
48978|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
48979|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
48980|NCT02096718|E3|Reported Event|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
48981|NCT02096718|E2|Reported Event|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
48982|NCT02096718|E1|Reported Event|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
48983|NCT02096705|B3|Baseline|Total|Total of all reporting groups
48984|NCT02096705|B2|Baseline|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
48985|NCT02096705|B1|Baseline|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
48986|NCT02096705|P2|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
48987|NCT02096705|P1|Participant Flow|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
48988|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
48989|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
48990|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
48991|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
48992|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
48993|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
48994|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
48995|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
48996|NCT02096705|E2|Reported Event|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
97391|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
48998|NCT02096692|B1|Baseline|ICD System Therapy|"Patients with a ProMRI ICD System
Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
48999|NCT02096692|P1|Participant Flow|ICD System Therapy|"Patients with a ProMRI ICD System
Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
49000|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System
Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
49001|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System
Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
49002|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System
Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
49003|NCT02096692|E1|Reported Event|ICD System Therapy|"Patients with a ProMRI ICD System
Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
49004|NCT02096679|B1|Baseline|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49005|NCT02096679|P1|Participant Flow|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49006|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49007|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49008|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49009|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49010|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49011|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49012|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49013|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49014|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49015|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49016|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49017|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49018|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49019|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49020|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49021|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49022|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49023|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49024|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49025|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49026|NCT02096679|E1|Reported Event|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
49027|NCT02096575|B3|Baseline|Total|Total of all reporting groups
49028|NCT02096575|B2|Baseline|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
49029|NCT02096575|B1|Baseline|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.
Nitrous oxide administration"
49031|NCT02096575|P2|Participant Flow|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
49032|NCT02096575|P1|Participant Flow|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.
Nitrous oxide administration"
49033|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
49034|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
49035|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
49036|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
49037|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
49038|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.
Nitrous oxide administration: The NO group will get two placebo pills."
49039|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
49040|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.
Nitrous oxide administration: The NO group will get two placebo pills."
49041|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
49042|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
49071|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49043|NCT02096575|E2|Reported Event|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
49044|NCT02096575|E1|Reported Event|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.
Nitrous oxide administration: The NO group will get two placebo pills."
49045|NCT02096458|B1|Baseline|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
49046|NCT02096458|P1|Participant Flow|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
49047|NCT02096458|O1|Outcome|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
49048|NCT02096458|E1|Reported Event|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
49049|NCT02096081|B3|Baseline|Total|Total of all reporting groups
49050|NCT02096081|B2|Baseline|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49051|NCT02096081|B1|Baseline|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49052|NCT02096081|P2|Participant Flow|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49053|NCT02096081|P1|Participant Flow|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49054|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49055|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49056|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49057|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49058|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49059|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49060|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49061|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49062|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49063|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49064|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49065|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49066|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49067|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49068|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49069|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49070|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49072|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49073|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49074|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49075|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49076|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49077|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49078|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49079|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49080|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49081|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49082|NCT02096081|E2|Reported Event|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
OnabotulinumtoxinA: 20U/injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49083|NCT02096081|E1|Reported Event|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.
IncobotulinumtoxinA: 20U/injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
49084|NCT02095873|B3|Baseline|Total|Total of all reporting groups
49085|NCT02095873|B2|Baseline|Placebo Then Glyoxalase 1 Inducer|Placebo (excipient: 108 mg mannitol), once daily, 8 weeks; then Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks.
49086|NCT02095873|B1|Baseline|Glyoxalase 1 Inducer Then Placebo|Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks; then Placebo (excipient: 108 mg mannitol), once daily, 8 weeks.
49087|NCT02095873|P2|Participant Flow|Placebo Then Glyoxalase 1 Inducer|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks; then Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
49088|NCT02095873|P1|Participant Flow|Glyoxalase 1 Inducer First, Then Placebo|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks; then Placebo (excipient: Mannitol, 108 mg) once daily, 8 weeks.
49089|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
49090|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
49091|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
49092|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
49093|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
49094|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
49095|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: 108 mg mannitol), capsule, once daily, 8 weeks.
49096|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks.
49097|NCT02095873|E2|Reported Event|Placebo Then Glo1-inducer|Placebo capsule (mannitol, 210 mg), once daily for 8 weeks; then 6-weeks washout; then Glyoxalase 1 inducer: capsule, 90 mg trans-resveratrol & 120 mg hesperetin, once daily for 8 weeks.
49098|NCT02095873|E1|Reported Event|Glo1-inducer Then Placebo|Glyoxalase 1 inducer: capsule, 90 mg trans-resveratrol & 120 mg hesperetin, once daily for 8 weeks; then 6-weeks washout; then placebo capsule (mannitol, 210 mg), once daily for 8 weeks.
49099|NCT02095691|B1|Baseline|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
49100|NCT02095691|P1|Participant Flow|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
49101|NCT02095691|O4|Outcome|At 12 Month Follow Up|Percentage of subjects achieving target SBP reduction at 12 months follow up
49102|NCT02095691|O3|Outcome|At 6 Months Follow Up|Percentage of subjects achieving target SBP reduction at 6 months follow up
49103|NCT02095691|O2|Outcome|At 3 Months Follow Up|Percentage of subjects achieving target SBP reduction at 3 months follow up
49104|NCT02095691|O1|Outcome|At 1 Month Follow up|Percentage of subjects achieving target SBP reduction at 1 month follow up
49105|NCT02095691|O4|Outcome|At 12 Month Follow Up|Percentage of subjects achieving target SBP at 12 months follow up
49106|NCT02095691|O3|Outcome|At 6 Months Follow Up|Percentage of subjects achieving target SBP at 6 months follow up
49107|NCT02095691|O2|Outcome|At 3 Months Follow Up|Percentage of subjects achieving target SBP at 3 months follow up
49110|NCT02095691|O3|Outcome|Change in Blood Pressure at 6 Months Follow Up|Change in Blood Pressure from baseline to 6 months follow up
49111|NCT02095691|O2|Outcome|Change in Blood Pressure at 3 Months Follow Up|Change in Blood Pressure from baseline to3 months follow up
49112|NCT02095691|O1|Outcome|Change in Blood Pressure at 1 Month Follow up|Change in Blood Pressure from baseline to1 month follow up
49113|NCT02095691|O1|Outcome|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
49114|NCT02095691|O1|Outcome|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
49115|NCT02095691|E1|Reported Event|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
49116|NCT02095561|B3|Baseline|Total|Total of all reporting groups
49117|NCT02095561|B2|Baseline|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
49118|NCT02095561|B1|Baseline|HPV Self Testing|"HPV self testing offered by CHWs during home visits
HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
49119|NCT02095561|P2|Participant Flow|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
49120|NCT02095561|P1|Participant Flow|HPV Self Testing|"HPV self testing offered by CHWs during home visits
HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
49121|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
49122|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits
HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
49123|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
49124|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits
HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
49125|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
49126|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits
HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
49127|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
49128|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits
HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
49129|NCT02095561|E2|Reported Event|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
49130|NCT02095561|E1|Reported Event|HPV Self Testing|"HPV self testing offered by CHWs during home visits
HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
49131|NCT02095535|B1|Baseline|Study Group|"All study participants
Chlorhexidine gluconate: antiseptic"
49132|NCT02095535|P1|Participant Flow|Study Group|"All study participants
Chlorhexidine gluconate: antiseptic"
49133|NCT02095535|O1|Outcome|Study Group|"All study participants
Chlorhexidine gluconate: antiseptic"
49134|NCT02095535|E1|Reported Event|Study Group|"All study participants
Chlorhexidine gluconate: antiseptic"
49135|NCT02095223|B3|Baseline|Total|Total of all reporting groups
49136|NCT02095223|B2|Baseline|Traditional Exercise Group|"Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.
Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only."
49150|NCT02095197|P1|Participant Flow|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
No Catheter Delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49490|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
49151|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Catheter targeted delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49508|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
49137|NCT02095223|B1|Baseline|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
49138|NCT02095223|P2|Participant Flow|Traditional Exercise Group|"Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.
Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only."
49139|NCT02095223|P1|Participant Flow|Electromyographic Biofeedback Group|"Participants in the electromyographic biofeedback supplemented exercise will be instructed on correct setup and use of the electromyographic biofeedback unit. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group. Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.
Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest."
49140|NCT02095223|O2|Outcome|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
49141|NCT02095223|O1|Outcome|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
49142|NCT02095223|O2|Outcome|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
49143|NCT02095223|O1|Outcome|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
49144|NCT02095223|E2|Reported Event|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
49145|NCT02095223|E1|Reported Event|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
49146|NCT02095197|B3|Baseline|Total|Total of all reporting groups
49147|NCT02095197|B2|Baseline|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Catheter targeted delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49148|NCT02095197|B1|Baseline|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
No Catheter Delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49149|NCT02095197|P2|Participant Flow|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Catheter targeted delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
97392|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
49152|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
No Catheter Delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49153|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Catheter targeted delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49154|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
No Catheter Delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49155|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Catheter targeted delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49156|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
No Catheter Delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49157|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Catheter targeted delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49158|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
No Catheter Delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49159|NCT02095197|E2|Reported Event|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Catheter targeted delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49160|NCT02095197|E1|Reported Event|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
No Catheter Delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
49161|NCT02095158|B1|Baseline|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
49162|NCT02095158|P1|Participant Flow|Oxymetazoline HCL Cream 1.0%|Oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
49163|NCT02095158|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
49164|NCT02095158|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
49165|NCT02095158|E1|Reported Event|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
49166|NCT02094937|B1|Baseline|Period 1- FF/VI 100/25 mcg OD|Participants received FF/VI 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
49167|NCT02094937|P4|Participant Flow|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49168|NCT02094937|P3|Participant Flow|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49169|NCT02094937|P2|Participant Flow|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49170|NCT02094937|P1|Participant Flow|FF/VI 100/25 mcg OD|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
49171|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49172|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49173|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49174|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49491|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
49175|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49176|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49177|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49178|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49179|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49180|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49181|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49182|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49183|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49184|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49185|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49186|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49187|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49188|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49189|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49190|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49191|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49192|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49193|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49194|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49195|NCT02094937|E4|Reported Event|FP 250 mcg BD Period 2|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49196|NCT02094937|E3|Reported Event|FP 100 mcg BD Period 2|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49235|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49236|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49237|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49238|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49197|NCT02094937|E2|Reported Event|FF 100 mcg OD Period 2|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
49198|NCT02094937|E1|Reported Event|FF/VI 100/25 mcg OD Period 1|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
49199|NCT02094898|B1|Baseline|Ketamine Infusion|"This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.
Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes"
49200|NCT02094898|P1|Participant Flow|Ketamine Infusion|"This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.
Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes"
49201|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49202|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49203|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49204|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49205|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49206|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49207|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49208|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49209|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49210|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49211|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49212|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49213|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49214|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49215|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49216|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49217|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49218|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49219|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49220|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49221|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49222|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49223|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49224|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49225|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49226|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49227|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49228|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49229|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49230|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49231|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49232|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49233|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49234|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49240|NCT02094898|O3|Outcome|Non-Remission|Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion
49241|NCT02094898|O2|Outcome|Remission|Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
49242|NCT02094898|O1|Outcome|Entire Cohort|All enrolled subjects receiving at least one acute-phase ketamine infusion.
49243|NCT02094898|E1|Reported Event|Ketamine Infusion|"This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.
Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes"
49244|NCT02094885|B3|Baseline|Total|Total of all reporting groups
49245|NCT02094885|B2|Baseline|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
49246|NCT02094885|B1|Baseline|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
49247|NCT02094885|P2|Participant Flow|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
49248|NCT02094885|P1|Participant Flow|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
49249|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
49250|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
49251|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
49252|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
49253|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
49254|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
49255|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
49256|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
49257|NCT02094885|E2|Reported Event|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
49258|NCT02094885|E1|Reported Event|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
49259|NCT02094677|B3|Baseline|Total|Total of all reporting groups
49260|NCT02094677|B2|Baseline|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49261|NCT02094677|B1|Baseline|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49262|NCT02094677|P2|Participant Flow|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49263|NCT02094677|P1|Participant Flow|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49264|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49265|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49266|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49267|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49268|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49481|NCT02093923|P1|Participant Flow|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
49269|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49382|NCT02094534|B1|Baseline|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801
ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed’s proprietary formulation in capsules."
49270|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49271|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49272|NCT02094677|O2|Outcome|Control - Nelilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49273|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49274|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49275|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49276|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49277|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49278|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49279|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49280|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49281|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49282|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49283|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49284|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49285|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49286|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens"
49287|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens"
49288|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49289|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49290|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49291|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49292|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49293|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49294|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49295|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49296|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49297|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49298|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49299|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49300|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49301|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49302|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49303|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49304|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49305|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49306|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49307|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49308|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49309|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49310|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49311|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49312|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49313|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49314|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49315|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49316|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49317|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49318|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49319|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49320|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
49383|NCT02094534|P2|Participant Flow|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
49509|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
49321|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens."
49322|NCT02094677|E2|Reported Event|Filcon II 3 and Nelfilcon A|"Participants wear one of their habitual brand lenses (nelfilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye.
filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.
nelfilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other."
49323|NCT02094677|E1|Reported Event|Filcon II 3 and Etafilcon A|"Participants wear one of their habitual brand lenses (etafilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye.
filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.
etafilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other."
49324|NCT02094612|B3|Baseline|Total|Total of all reporting groups
49325|NCT02094612|B2|Baseline|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®
Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
49326|NCT02094612|B1|Baseline|Usual Care|"Usual clinic ADHD care
Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
49327|NCT02094612|P2|Participant Flow|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®
Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
49328|NCT02094612|P1|Participant Flow|Usual Care|"Usual clinic ADHD care
Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
49329|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®
Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
49330|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care
Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
49331|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®
Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
49332|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care
Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
49333|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®
Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
49334|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care
Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
49335|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®
Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
49336|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care
Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
49337|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®
Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
49338|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care
Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
49339|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®
Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
49340|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care
Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
49341|NCT02094612|O2|Outcome|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®
Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
49342|NCT02094612|O1|Outcome|Usual Care|"Usual clinic ADHD care
Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
49343|NCT02094612|E2|Reported Event|Usual Care Plus Assessment|"Usual clinic ADHD care plus the Quotient®
Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers."
49344|NCT02094612|E1|Reported Event|Usual Care|"Usual clinic ADHD care
Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic"
49345|NCT02094573|B3|Baseline|Total|Total of all reporting groups
49346|NCT02094573|B2|Baseline|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49347|NCT02094573|B1|Baseline|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49348|NCT02094573|P2|Participant Flow|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49349|NCT02094573|P1|Participant Flow|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49350|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49351|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49482|NCT02093923|O4|Outcome|Placebo|Placebo administered twice, two weeks apart
49352|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49353|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49354|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49355|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49356|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49357|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49358|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49359|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49360|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49361|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49362|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49363|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49364|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49365|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49366|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49367|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49368|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49369|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49370|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49371|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49372|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49373|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49374|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49375|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49376|NCT02094573|O2|Outcome|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49377|NCT02094573|O1|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49378|NCT02094573|E2|Reported Event|Brigatinib 90 mg - 180 mg|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days until disease progression or intolerable toxicity.
49379|NCT02094573|E1|Reported Event|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily in each cycle of 28 days until disease progression or intolerable toxicity.
49380|NCT02094534|B3|Baseline|Total|Total of all reporting groups
49381|NCT02094534|B2|Baseline|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
49483|NCT02093923|O3|Outcome|DX-2930, Combined Dose Level 3 and Dose Level 4|This arm includes the total subjects analysed for Dose level 3 and Dose level 4 combined.
49384|NCT02094534|P1|Participant Flow|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801
ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed’s proprietary formulation in capsules."
49385|NCT02094534|O2|Outcome|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
49386|NCT02094534|O1|Outcome|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801
ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed’s proprietary formulation in capsules."
49387|NCT02094534|O2|Outcome|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
49388|NCT02094534|O1|Outcome|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801
ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed’s proprietary formulation in capsules."
49389|NCT02094534|E2|Reported Event|Placebo|Fish oil in capsules, identical in appearance to ORMD-0801
49390|NCT02094534|E1|Reported Event|ORMD-0801|"API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801
ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed’s proprietary formulation in capsules."
49391|NCT02094443|B3|Baseline|Total|Total of all reporting groups
49392|NCT02094443|B2|Baseline|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
49393|NCT02094443|B1|Baseline|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
49394|NCT02094443|P2|Participant Flow|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
49395|NCT02094443|P1|Participant Flow|Alisporivir 300 mg BID|Alisporivir (ALV) 300 mg twice per day (BID) with ribavirin (RBV) for up to 24 weeks.
49396|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
49397|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
49398|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
49399|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
49400|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
49401|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
49402|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
49403|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
49404|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
49405|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
49406|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
49407|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
49408|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
49409|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
49410|NCT02094443|E2|Reported Event|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
49411|NCT02094443|E1|Reported Event|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
49412|NCT02094352|B3|Baseline|Total|Total of all reporting groups
49413|NCT02094352|B2|Baseline|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three saline booster infusions over the course of three months.
Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.
Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
49414|NCT02094352|B1|Baseline|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three ketamine booster infusions over the course of three months.
Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
49415|NCT02094352|P2|Participant Flow|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three saline booster infusions over the course of three months.
Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.
Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
49416|NCT02094352|P1|Participant Flow|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three ketamine booster infusions over the course of three months.
Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
49417|NCT02094352|O2|Outcome|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three saline booster infusions over the course of three months.
Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.
Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
49484|NCT02093923|O2|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
49485|NCT02093923|O1|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
97393|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
49447|NCT02093962|O1|Outcome|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed
TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
49418|NCT02094352|O1|Outcome|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three ketamine booster infusions over the course of three months.
Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
49419|NCT02094352|E2|Reported Event|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three saline booster infusions over the course of three months.
Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.
Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
49420|NCT02094352|E1|Reported Event|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three ketamine booster infusions over the course of three months.
Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
49421|NCT02094326|B1|Baseline|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
49422|NCT02094326|P1|Participant Flow|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
49423|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
49424|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
49425|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
49426|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
49427|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the classification of rheumatoid arthritis (ACR) 2010 criteria from 2008 to 2012, and initiated on at least one disease-modifying antirheumatic drug (DMARD) during this period.
49428|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
49429|NCT02094326|E1|Reported Event|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
49430|NCT02094300|B1|Baseline|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
49431|NCT02094300|P1|Participant Flow|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
49432|NCT02094300|O1|Outcome|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
49433|NCT02094300|E1|Reported Event|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
49434|NCT02094261|B1|Baseline|AZD9291 80mg|Daily single dose of AZD9291 80mg
49435|NCT02094261|P1|Participant Flow|AZD9291 80mg|Daily single dose of AZD9291 80mg
49436|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
49437|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
49438|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
49439|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
49440|NCT02094261|E1|Reported Event|AZD9291 80mg|Daily single dose of AZD9291 80mg
49441|NCT02093962|B3|Baseline|Total|Total of all reporting groups
49442|NCT02093962|B2|Baseline|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed
Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
49443|NCT02093962|B1|Baseline|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed
TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
49444|NCT02093962|P2|Participant Flow|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed
Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
49445|NCT02093962|P1|Participant Flow|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed
TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
49446|NCT02093962|O2|Outcome|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed
Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
49486|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
49448|NCT02093962|E2|Reported Event|Placebo and Pemetrexed|"Matching placebo in combination with pemetrexed
Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
49449|NCT02093962|E1|Reported Event|TH-302 and Pemetrexed|"TH-302 in combination with pemetrexed
TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
49450|NCT02093949|B3|Baseline|Total|Total of all reporting groups
49451|NCT02093949|B2|Baseline|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
49452|NCT02093949|B1|Baseline|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation.
49453|NCT02093949|P2|Participant Flow|Historical Control|The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
49454|NCT02093949|P1|Participant Flow|Substrate Ablation|Between September 2013 and July 2014, 105 patients with AF were prospectively enrolled at three centers performing substrate ablation (without pulmonary vein isolation) routinely
49455|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
49456|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
49457|NCT02093949|O2|Outcome|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
49458|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation.
49459|NCT02093949|O2|Outcome|Historical Control Long Term Follow-up|"Out of the 47 patients included in the validation set arm, only 42 finished the 18-mlonth follow-up. 2 patients were lost to follow-up
Population at the end of follow up : 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)"
49460|NCT02093949|O1|Outcome|Substrate Ablation Long Term Follow-up|"Out of the 105 patients included in the substrate ablation arm, only 96 were included in the long term follow-up group.
9 patients (8.6%) did not complete the follow up: 1 patient died 2 months before the end of follow-up (myocardial infarction) and 8 were lost to follow-up because of relocation."
49461|NCT02093949|O2|Outcome|Historical Control Long Term Follow-up|"Out of the 47 patients included in the validation set arm, only 42 finished the 18-mlonth follow-up. 2 patients were lost to follow-up
Population at the end of follow up : 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)"
49462|NCT02093949|O1|Outcome|Substrate Ablation Long Term Follow Up|"Out of the 105 patients included in the substrate ablation arm, only 96 were included in the long term follow-up group.
9 patients (8.6%) did not complete the follow up: 1 patient died 2 months before the end of follow-up (myocardial infarction) and 8 were lost to follow-up because of relocation."
49463|NCT02093949|O2|Outcome|Historical Control|The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
49464|NCT02093949|O1|Outcome|Substrate Ablation|Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
49465|NCT02093949|O2|Outcome|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
49466|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
49467|NCT02093949|O2|Outcome|Historical Control|The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
49468|NCT02093949|O1|Outcome|Substrate Ablation|Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
49469|NCT02093949|E2|Reported Event|Historical Control|Validation set (n=47)
49470|NCT02093949|E1|Reported Event|Substrate Ablation|Study population (n=105)
49471|NCT02093923|B6|Baseline|Total|Total of all reporting groups
49472|NCT02093923|B5|Baseline|Placebo|Placebo administered twice, two weeks apart
49473|NCT02093923|B4|Baseline|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
49474|NCT02093923|B3|Baseline|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
49475|NCT02093923|B2|Baseline|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
49476|NCT02093923|B1|Baseline|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
49477|NCT02093923|P5|Participant Flow|Placebo|Placebo administered twice, two weeks apart
49478|NCT02093923|P4|Participant Flow|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
49479|NCT02093923|P3|Participant Flow|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
49480|NCT02093923|P2|Participant Flow|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
49492|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
49493|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
49494|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
49510|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
49511|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
49512|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
49513|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
49514|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
49515|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
49516|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
49517|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
49518|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
49519|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
49520|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
49521|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
49522|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
49523|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
49524|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
49525|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
49526|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
49527|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
49528|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
49529|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
49530|NCT02093923|E5|Reported Event|Placebo|Placebo administered twice, two weeks apart
49531|NCT02093923|E4|Reported Event|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
49532|NCT02093923|E3|Reported Event|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
49533|NCT02093923|E2|Reported Event|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
49534|NCT02093923|E1|Reported Event|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
49535|NCT02093897|B1|Baseline|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
49536|NCT02093897|P1|Participant Flow|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an intravenous (IV) infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the World Federation of Hemophilia (WFH), with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
49537|NCT02093897|O1|Outcome|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
49538|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
49539|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
49540|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
49541|NCT02093897|O1|Outcome|Pharmacokinetic Population|The Pharmacokinetic (PK) Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
49542|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
49558|NCT02093819|B6|Baseline|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
83984|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
49543|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
49544|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
49545|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
49546|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
49547|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
49548|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
49549|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
49550|NCT02093897|O1|Outcome|Efficacy Population|The Efficacy Population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either a routine prophylaxis or on-demand regimen during the study. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).
49551|NCT02093897|O2|Outcome|Prophylaxis|Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary.
49552|NCT02093897|O1|Outcome|On-demand|Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions.
49581|NCT02093819|O5|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49805|NCT02092662|P1|Participant Flow|Patients After a Stroke|Patients who admitted to the hospital for rehabilitation after a stroke
49553|NCT02093897|O1|Outcome|Efficacy Population|The Efficacy Population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either a routine prophylaxis or on-demand regimen during the study. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).
49554|NCT02093897|E1|Reported Event|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
49555|NCT02093819|B9|Baseline|Total|Total of all reporting groups
49556|NCT02093819|B8|Baseline|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49557|NCT02093819|B7|Baseline|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
83985|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
49559|NCT02093819|B5|Baseline|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49560|NCT02093819|B4|Baseline|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49561|NCT02093819|B3|Baseline|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49562|NCT02093819|B2|Baseline|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49563|NCT02093819|B1|Baseline|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49564|NCT02093819|P8|Participant Flow|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49565|NCT02093819|P7|Participant Flow|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49566|NCT02093819|P6|Participant Flow|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49567|NCT02093819|P5|Participant Flow|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49568|NCT02093819|P4|Participant Flow|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49569|NCT02093819|P3|Participant Flow|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49570|NCT02093819|P2|Participant Flow|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49571|NCT02093819|P1|Participant Flow|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49572|NCT02093819|O7|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49573|NCT02093819|O6|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49574|NCT02093819|O5|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49575|NCT02093819|O4|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49576|NCT02093819|O3|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (Dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49577|NCT02093819|O2|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49578|NCT02093819|O1|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49579|NCT02093819|O7|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49580|NCT02093819|O6|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49582|NCT02093819|O4|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49583|NCT02093819|O3|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (Dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49584|NCT02093819|O2|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49585|NCT02093819|O1|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49586|NCT02093819|O8|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49587|NCT02093819|O7|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49588|NCT02093819|O6|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49589|NCT02093819|O5|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49958|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49590|NCT02093819|O4|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49591|NCT02093819|O3|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49592|NCT02093819|O2|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49593|NCT02093819|O1|Outcome|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h
49594|NCT02093819|E10|Reported Event|Total Treatment|All patients affected by AEs during entire treatment period.
49595|NCT02093819|E9|Reported Event|Total BI 416970 Treatment|All patients affected by AEs during administration of BI 416970 medication .
49596|NCT02093819|E8|Reported Event|BI 416970 600 mg|The medication was administered as a single oral dose (dose = 600 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49597|NCT02093819|E7|Reported Event|BI 416970 400 mg|The medication was administered as a single oral dose (dose = 400 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49598|NCT02093819|E6|Reported Event|BI 416970 200 mg|The medication was administered as a single oral dose (dose = 200 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49599|NCT02093819|E5|Reported Event|BI 416970 100 mg|The medication was administered as a single oral dose (dose = 100 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49600|NCT02093819|E4|Reported Event|BI 416970 50 mg|The medication was administered as a single oral dose (dose = 50 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49601|NCT02093819|E3|Reported Event|BI 416970 25 mg|The medication was administered as a single oral dose (dose = 25 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49602|NCT02093819|E2|Reported Event|BI 416970 10 mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49603|NCT02093819|E1|Reported Event|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
49604|NCT02093702|B3|Baseline|Total|Total of all reporting groups
49605|NCT02093702|B2|Baseline|Structured PA Education Program for People With T2DM|Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
49606|NCT02093702|B1|Baseline|Standard PA Education for People With T2DM (From a CDE)|Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
49607|NCT02093702|P2|Participant Flow|Structured PA Education Program for People With T2DM|Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
49608|NCT02093702|P1|Participant Flow|Standard PA Education for People With T2DM (From a CDE)|Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
49609|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49610|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49611|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49612|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49613|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
97394|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
49614|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49615|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49616|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49617|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49618|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49619|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49620|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49621|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49622|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49623|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49624|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49625|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49626|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49627|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49628|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49629|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49630|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49631|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49632|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49633|NCT02093702|E2|Reported Event|Standard PA Education for People With T2DM (From a CDE)|Group of subjects receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
49634|NCT02093702|E1|Reported Event|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
49635|NCT02093520|B3|Baseline|Total|Total of all reporting groups
49636|NCT02093520|B2|Baseline|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
49637|NCT02093520|B1|Baseline|MILD|"Image guided minimally-invasive lumbar decompression
Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
49638|NCT02093520|P2|Participant Flow|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
49639|NCT02093520|P1|Participant Flow|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression
Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
49640|NCT02093520|O2|Outcome|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
49641|NCT02093520|O1|Outcome|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression
Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
49642|NCT02093520|O2|Outcome|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
49643|NCT02093520|O1|Outcome|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression
Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
49644|NCT02093520|O2|Outcome|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
49645|NCT02093520|O1|Outcome|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression
Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
49646|NCT02093520|E2|Reported Event|Epidural Steroid Injection (ESI)|"An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
49647|NCT02093520|E1|Reported Event|Minimally Invasive Lumbar Decompression (MILD)|"Image guided minimally-invasive lumbar decompression
Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
49648|NCT02093390|B3|Baseline|Total|Total of all reporting groups
49959|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49649|NCT02093390|B2|Baseline|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49650|NCT02093390|B1|Baseline|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49651|NCT02093390|P2|Participant Flow|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49652|NCT02093390|P1|Participant Flow|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49653|NCT02093390|O1|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49654|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49655|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49656|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49657|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49658|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49659|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49660|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49661|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49662|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49663|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49664|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49948|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49665|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49666|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49667|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49668|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49669|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49960|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49670|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49671|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49672|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49673|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49674|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49675|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49676|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49677|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49678|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49679|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49680|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49681|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49682|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49683|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49684|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49685|NCT02093390|E2|Reported Event|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
49795|NCT02092857|O3|Outcome|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
97395|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
49686|NCT02093390|E1|Reported Event|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
49687|NCT02093351|B4|Baseline|Total|Total of all reporting groups
49688|NCT02093351|B3|Baseline|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
49689|NCT02093351|B2|Baseline|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
49690|NCT02093351|B1|Baseline|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
49813|NCT02092649|B1|Baseline|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete"
49691|NCT02093351|P3|Participant Flow|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
49692|NCT02093351|P2|Participant Flow|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
49693|NCT02093351|P1|Participant Flow|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
49694|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
49695|NCT02093351|O1|Outcome|Cohort 3 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
49696|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
49697|NCT02093351|O1|Outcome|Cohort 3 - Letrozole Alone (Treatment Period 2)|Patients in Cohort 3 received letrozole 2.5 mg od from Day 10 to Day 38. Blood sampling for PK analysis was taken on Day 38.
49698|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
49699|NCT02093351|O1|Outcome|Cohort 2 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
49700|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
49701|NCT02093351|O1|Outcome|Cohort 2 - Anastrozole Alone (Treatment Period 2)|Patients in Cohort 2 received anastrozole 1 mg od from Day 10 to Day 19. Blood sampling for PK analysis was taken on Day 19.
49702|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
49703|NCT02093351|O1|Outcome|Cohort 1 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
49704|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
49705|NCT02093351|O1|Outcome|Cohort 1 - Tamoxifen Alone (Treatment Period 2)|Patients in Cohort 1 received tamoxifen 60 mg od from Day 10 to Day 13 (loading dose). From Day 14 to Day 26 patients received tamoxifen 20 mg od (maintenance dose). Blood sampling for PK analysis was taken on Day 26.
49706|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
49707|NCT02093351|O1|Outcome|Cohort 3 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
49708|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
49709|NCT02093351|O1|Outcome|Cohort 3 - Letrozole Alone (Treatment Period 2)|Patients in Cohort 3 received letrozole 2.5 mg od from Day 10 to Day 38. Blood sampling for PK analysis was taken on Day 38.
49710|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
49711|NCT02093351|O1|Outcome|Cohort 2 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
49712|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
49713|NCT02093351|O1|Outcome|Cohort 2 - Anastrozole Alone (Treatment Period 2)|Patients in Cohort 2 received anastrozole 1 mg od from Day 10 to Day 19. Blood sampling for PK analysis was taken on Day 19.
49714|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
49715|NCT02093351|O1|Outcome|Cohort 1 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
49716|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
49717|NCT02093351|O1|Outcome|Cohort 1 - Tamoxifen Alone (Treatment Period 2)|Patients in Cohort 1 received tamoxifen 60 mg od from Day 10 to Day 13 (loading dose). From Day 14 to Day 26 patients received tamoxifen 20 mg od (maintenance dose). Blood sampling for PK analysis was taken on Day 26.
49718|NCT02093351|E3|Reported Event|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
49719|NCT02093351|E2|Reported Event|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
49720|NCT02093351|E1|Reported Event|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
49721|NCT02093234|B4|Baseline|Total|Total of all reporting groups
49722|NCT02093234|B3|Baseline|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application
CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
49723|NCT02093234|B2|Baseline|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.
Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
49724|NCT02093234|B1|Baseline|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.
mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
49725|NCT02093234|P3|Participant Flow|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application
CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
49726|NCT02093234|P2|Participant Flow|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.
Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
49727|NCT02093234|P1|Participant Flow|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.
mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
49728|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application
CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
49729|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.
Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
49730|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.
mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
49731|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application
CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
49732|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.
Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
49733|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.
mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
49734|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application
CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
49735|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.
Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
49736|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.
mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
49737|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application
CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
49738|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.
Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
49806|NCT02092662|O2|Outcome|Healthy Controls|"healthy age-matched voluntiers
Healthy controls: no treatment
Deltoid onset time 0.79 sec"
49739|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.
mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
49740|NCT02093234|E3|Reported Event|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application
CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
49741|NCT02093234|E2|Reported Event|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.
Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
49742|NCT02093234|E1|Reported Event|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.
mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
49961|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49743|NCT02093026|B1|Baseline|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49744|NCT02093026|P1|Participant Flow|Rituximab|Participants received rituximab 1 gram intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 milligrams per week (mg/week) orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid greater than or equal to (>=) 5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49745|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49746|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49747|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49748|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49796|NCT02092857|O2|Outcome|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
49797|NCT02092857|O1|Outcome|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
49798|NCT02092857|E3|Reported Event|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
49799|NCT02092857|E2|Reported Event|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
49800|NCT02092857|E1|Reported Event|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
49749|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49814|NCT02092649|P2|Participant Flow|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill"
49962|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49750|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49751|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49752|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49753|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49754|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49755|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49756|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49801|NCT02092662|B3|Baseline|Total|Total of all reporting groups
49802|NCT02092662|B2|Baseline|Control|healthy volunteers
49803|NCT02092662|B1|Baseline|Study|patients after a stroke
49804|NCT02092662|P2|Participant Flow|Control|Healthy voluntiers
49757|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49758|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49759|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49760|NCT02093026|E2|Reported Event|Placebo|Data for participants who received placebo in Study WA17043 or WA16291 are included in this reporting group for data collected until they received their first dose of rituximab in this study (Study WA16855). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
49761|NCT02093026|E1|Reported Event|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
49762|NCT02092961|B4|Baseline|Total|Total of all reporting groups
49763|NCT02092961|B3|Baseline|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
49764|NCT02092961|B2|Baseline|ADALIMUMAB 40 MG SC|Dosing Group D
49765|NCT02092961|B1|Baseline|FOSTA 100 MG PO BID|Dosing Group A
49766|NCT02092961|P3|Participant Flow|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
49767|NCT02092961|P2|Participant Flow|ADALIMUMAB 40 MG SC|Dosing Group D
49768|NCT02092961|P1|Participant Flow|FOSTA 100 MG PO BID|Dosing Group A
49769|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
49770|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
49771|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
49772|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
49773|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
49774|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
49775|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
49776|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
49777|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
49778|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
49779|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
49780|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
49781|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
49782|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
49783|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
49784|NCT02092961|E4|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period|
49785|NCT02092961|E3|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period|
49786|NCT02092961|E2|Reported Event|FOSTA 100 MG BID|Dosing Group A
49787|NCT02092961|E1|Reported Event|ADALIMUMAB 40 MG|Dosing Group D
49788|NCT02092857|B4|Baseline|Total|Total of all reporting groups
49789|NCT02092857|B3|Baseline|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
49790|NCT02092857|B2|Baseline|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
49791|NCT02092857|B1|Baseline|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
49792|NCT02092857|P3|Participant Flow|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
49793|NCT02092857|P2|Participant Flow|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
49794|NCT02092857|P1|Participant Flow|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
49807|NCT02092662|O1|Outcome|Stroke|"Stroke patients at the subacute phase
stroke: task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context."
49808|NCT02092662|O2|Outcome|Control|Healthy age-matched
49809|NCT02092662|O1|Outcome|Study Group (T1)|Patients after a stroke
49810|NCT02092662|E1|Reported Event|Study|Patients after a stroke
49811|NCT02092649|B3|Baseline|Total|Total of all reporting groups
49812|NCT02092649|B2|Baseline|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill"
49963|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49815|NCT02092649|P1|Participant Flow|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete"
49816|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill"
49817|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete"
49818|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill"
49819|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete"
49820|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill"
49821|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete"
49822|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill"
49823|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete"
49824|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill"
49825|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete"
49826|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill"
49827|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete"
49828|NCT02092649|E2|Reported Event|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill"
49829|NCT02092649|E1|Reported Event|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete"
49830|NCT02092610|B3|Baseline|Total|Total of all reporting groups
49831|NCT02092610|B2|Baseline|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.
Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
49832|NCT02092610|B1|Baseline|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long
Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
49833|NCT02092610|P2|Participant Flow|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.
Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
49834|NCT02092610|P1|Participant Flow|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long
Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
49835|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.
Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
49836|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long
Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
49837|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.
Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
49838|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long
Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
49839|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.
Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
49887|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
83986|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
49840|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long
Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
49841|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.
Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
49842|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long
Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
49843|NCT02092610|E2|Reported Event|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.
Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
49844|NCT02092610|E1|Reported Event|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long
Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
49845|NCT02092441|B3|Baseline|Total|Total of all reporting groups
49846|NCT02092441|B2|Baseline|Normal Saline Prep Pad|"normal saline prep pad
Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
49847|NCT02092441|B1|Baseline|Alcohol Prep Pad Group|"isopropyl alcohol prep pad
Alcohol prep pad group: Subjects inhale scent of alcohol pad"
49848|NCT02092441|P2|Participant Flow|Normal Saline Prep Pad|"normal saline prep pad
Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
49849|NCT02092441|P1|Participant Flow|Alcohol Prep Pad Group|"isopropyl alcohol prep pad
Alcohol prep pad group: Subjects inhale scent of alcohol pad"
49850|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad
Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
49851|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad
Alcohol prep pad group: Subjects inhale scent of alcohol pad"
49852|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad
Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
49853|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad
Alcohol prep pad group: Subjects inhale scent of alcohol pad"
49854|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad
Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
49855|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad
Alcohol prep pad group: Subjects inhale scent of alcohol pad"
49856|NCT02092441|E2|Reported Event|Normal Saline Prep Pad|"normal saline prep pad
Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
49857|NCT02092441|E1|Reported Event|Alcohol Prep Pad Group|"isopropyl alcohol prep pad
Alcohol prep pad group: Subjects inhale scent of alcohol pad"
49858|NCT02092415|B1|Baseline|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet
Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
49859|NCT02092415|P1|Participant Flow|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet
Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
49860|NCT02092415|O2|Outcome|Normal Subjects - Tourniquet Flow|Perfusion measured at time of tourniquet placement
49861|NCT02092415|O1|Outcome|Normal Subjects Baseline Flow|"Normal subjects, all of whom undergo brief application of junctional tourniquet
Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
49862|NCT02092415|E1|Reported Event|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet
Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
49863|NCT02092389|B1|Baseline|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
49864|NCT02092389|P1|Participant Flow|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
49944|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49945|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49865|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
49888|NCT02092350|E3|Reported Event|Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks|Participants received a FDC tablet containing GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
49964|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49866|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
49867|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
49868|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
49869|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
49870|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
49871|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
49872|NCT02092389|E1|Reported Event|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
49873|NCT02092350|B3|Baseline|Total|Total of all reporting groups
49874|NCT02092350|B2|Baseline|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
49875|NCT02092350|B1|Baseline|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
49876|NCT02092350|P2|Participant Flow|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a fixed dose combination (FDC) tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
49877|NCT02092350|P1|Participant Flow|Immediate Treatment + Intensive PK|Participants received grazoprevir (GZR) 100 mg tablet + elbasvir (EBR) 50 mg tablet once daily (q.d.) by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive pharmacokinetics (PK) testing.
49878|NCT02092350|O2|Outcome|Deferred Treatment Group|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
49879|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
49880|NCT02092350|O2|Outcome|Deferred Treatment Group|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
49881|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
49882|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
49883|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
49884|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
49885|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
49946|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49947|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49886|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
49955|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49889|NCT02092350|E2|Reported Event|Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks, followed by a 4-week drug-free period.
49890|NCT02092350|E1|Reported Event|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
49891|NCT02092311|B3|Baseline|Total|Total of all reporting groups
49892|NCT02092311|B2|Baseline|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
49893|NCT02092311|B1|Baseline|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
49894|NCT02092311|P2|Participant Flow|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
49895|NCT02092311|P1|Participant Flow|Combined Microscopic Varicocelectomy|Combined Mini-Incision Microscopic Varicocelectomy
49896|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
49897|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
49898|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
49899|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
49900|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
49901|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
49902|NCT02092311|E2|Reported Event|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
49903|NCT02092311|E1|Reported Event|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
49904|NCT02092168|B3|Baseline|Total|Total of all reporting groups
49905|NCT02092168|B2|Baseline|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Young Subjects"
49906|NCT02092168|B1|Baseline|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Elderly Subjects"
49907|NCT02092168|P2|Participant Flow|BIA 9-1067 30 mg (QD) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (QD) - Young Subjects"
49908|NCT02092168|P1|Participant Flow|BIA 9-1067 30 mg (QD) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (QD) - Elderly Subjects"
49909|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Young Subjects"
49910|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Elderly Subjects"
49911|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Young Subjects"
49912|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Elderly Subjects"
49913|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Young Subjects"
49914|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Elderly Subjects"
49915|NCT02092168|E2|Reported Event|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Young Subjects"
49916|NCT02092168|E1|Reported Event|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Elderly Subjects"
49917|NCT02092116|B3|Baseline|Total|Total of all reporting groups
49918|NCT02092116|B2|Baseline|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).
A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.
A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
49956|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49957|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49919|NCT02092116|B1|Baseline|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.
Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
49920|NCT02092116|P2|Participant Flow|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).
A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.
A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
49921|NCT02092116|P1|Participant Flow|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.
Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
49922|NCT02092116|O1|Outcome|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).
A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.
A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
49923|NCT02092116|O1|Outcome|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).
A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.
A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
49924|NCT02092116|O1|Outcome|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.
Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
49925|NCT02092116|O1|Outcome|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).
A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.
A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
49926|NCT02092116|O1|Outcome|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.
Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
49927|NCT02092116|E2|Reported Event|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).
A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of romidepsin infusion (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.
A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
49928|NCT02092116|E1|Reported Event|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.
Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
49929|NCT02091986|B4|Baseline|Total|Total of all reporting groups
49930|NCT02091986|B3|Baseline|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49931|NCT02091986|B2|Baseline|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49932|NCT02091986|B1|Baseline|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49933|NCT02091986|P3|Participant Flow|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49934|NCT02091986|P2|Participant Flow|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49935|NCT02091986|P1|Participant Flow|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49936|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49937|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49938|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49939|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49940|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49941|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49942|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49943|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49949|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49950|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49951|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49952|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49953|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49954|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49965|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49966|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49967|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49968|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49969|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49970|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49971|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49972|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49973|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49974|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49975|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49976|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
49977|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49978|NCT02091986|E3|Reported Event|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
49979|NCT02091986|E2|Reported Event|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49980|NCT02091986|E1|Reported Event|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
49981|NCT02091869|B3|Baseline|Total|Total of all reporting groups
49982|NCT02091869|B2|Baseline|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.
Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
49983|NCT02091869|B1|Baseline|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.
Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
49984|NCT02091869|P2|Participant Flow|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.
Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
49985|NCT02091869|P1|Participant Flow|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.
Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
49986|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.
Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
49987|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.
Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
49988|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.
Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
49989|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.
Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
49990|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.
Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
49991|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.
Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
49992|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.
Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
49993|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.
Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
49994|NCT02091869|E2|Reported Event|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.
Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
50175|NCT02090088|E1|Reported Event|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
49995|NCT02091869|E1|Reported Event|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.
Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
49996|NCT02091856|B4|Baseline|Total|Total of all reporting groups
49997|NCT02091856|B3|Baseline|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
49998|NCT02091856|B2|Baseline|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
50040|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
49999|NCT02091856|B1|Baseline|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
50000|NCT02091856|P3|Participant Flow|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
50001|NCT02091856|P2|Participant Flow|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
50002|NCT02091856|P1|Participant Flow|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
50003|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
50004|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
50005|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
50006|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
50007|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
50008|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
50009|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
50010|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
50305|NCT02087670|B2|Baseline|Community Based Exercise|educational program and not supervises exercise program
50011|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
50012|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
50041|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
50188|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
83987|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
50013|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
50014|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
50015|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
50016|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
50017|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
50018|NCT02091856|E3|Reported Event|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
50019|NCT02091856|E2|Reported Event|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
50020|NCT02091856|E1|Reported Event|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
50021|NCT02091778|B1|Baseline|Fast Gelling Dressing|Fast gelling dressing
50022|NCT02091778|P1|Participant Flow|Fast Gelling Dressing|Fast gelling dressing
50023|NCT02091778|O1|Outcome|Fast Gelling Dressing|Fast gelling dressing
50024|NCT02091778|E1|Reported Event|Fast Gelling Dressing|Fast gelling dressing
50025|NCT02091752|B1|Baseline|Ruxolitinib|All participants received ruxolitinib.
50026|NCT02091752|P1|Participant Flow|Ruxolitinib|All participants received ruxolitinib.
50027|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
50028|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
50029|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
50030|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
50031|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
50032|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
50033|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
50034|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
50035|NCT02091752|E1|Reported Event|Ruxolitinib|All participants received ruxolitinib.
50036|NCT02091726|B1|Baseline|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
50037|NCT02091726|P1|Participant Flow|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
50176|NCT02089737|B1|Baseline|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
50038|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
50039|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
50189|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
50042|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
50043|NCT02091726|E1|Reported Event|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
50044|NCT02091466|B3|Baseline|Total|Total of all reporting groups
50045|NCT02091466|B2|Baseline|Control|Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
50046|NCT02091466|B1|Baseline|Pre-warming|Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
50047|NCT02091466|P2|Participant Flow|Control|patients were under passive heating in control groups before anesthesia
50048|NCT02091466|P1|Participant Flow|Pre-warming|"patients were under heating system in experimental groups
heating system pre-warming: warming 30 minutes prior to anesthesia"
50049|NCT02091466|O2|Outcome|Control|Patients remained without the use of a thermal gown,
50050|NCT02091466|O1|Outcome|Pre-warming|Patients were covered with a thermal gown (Bair Paws Standard Warming Gown 810 model with a Bair Hugger, model 850 warming unit) with forced-air flow at 40ºC in the preoperative care unit 30 minutes before the spinal anesthesia.
50051|NCT02091466|E2|Reported Event|Control|Patients were under passive heating in control groups before anesthesia
50052|NCT02091466|E1|Reported Event|Pre-warming|"Patients were under heating system in experimental groups
heating system pre-warming: warming 30 minutes prior to anesthesia"
50053|NCT02091414|B1|Baseline|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50054|NCT02091414|P1|Participant Flow|Mycophenolate Mofetil (MMF) Plus (+) Cyclosporine A (CsA)|Participants received MMF 1.0 grams (g), capsules orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 milligrams per kilogram (mg/kg) PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50055|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50056|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50057|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50058|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50059|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50060|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50061|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50062|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50096|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50190|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
50063|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50064|NCT02091414|E1|Reported Event|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
50065|NCT02090855|B1|Baseline|Flutemetamol (18F)|There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered.
50066|NCT02090855|P1|Participant Flow|Flutemetamol (18F)|There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007.
50067|NCT02090855|O1|Outcome|Percentage of Specificity for Normal Reads|This is the percentage of Specificity with the normal image interpretations.
50068|NCT02090855|O1|Outcome|Percentage of Sensitivity With Abnormal Reads|This is the percent of sensitivity with the Abnormal image interpretations.
50069|NCT02090855|O1|Outcome|Standard of Truth (SoT)|Each Reader will have a total of 30 image interpretations when combining normal and abnormal readings.The Standard of Truth (SoT) is based on no/sparse neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) criteria based on specimens stained with the Bielschowsky silver stain.
50070|NCT02090855|O1|Outcome|Standard of Truth (SoT)|Each Reader will have a total of 76 image interpretations when combining normal and abnormal readings.The Standard of Truth is based on moderate/frequent neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) criteria, based on specimens stained with the Bielschowsky silver stain.
50071|NCT02090855|E1|Reported Event|Flutemetamol (18F)|This study was to assess the PET images only. There was no drug administered in this study.
50072|NCT02090777|B1|Baseline|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.
Health Coach"
50073|NCT02090777|P1|Participant Flow|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.
Health Coach"
50074|NCT02090777|O1|Outcome|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.
Health Coach"
50075|NCT02090777|E1|Reported Event|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.
Health Coach"
50076|NCT02090764|B3|Baseline|Total|Total of all reporting groups
50077|NCT02090764|B2|Baseline|Placebo|"Placebo cream
Placebo"
50078|NCT02090764|B1|Baseline|Ozenoxacin|"ozenoxacin cream 1%
Ozenoxacin"
50079|NCT02090764|P2|Participant Flow|Placebo|"Placebo cream
Placebo"
50080|NCT02090764|P1|Participant Flow|Ozenoxacin|"ozenoxacin cream 1%
Ozenoxacin"
50081|NCT02090764|O2|Outcome|Placebo|"Placebo cream
Placebo"
50082|NCT02090764|O1|Outcome|Ozenoxacin|"ozenoxacin cream 1%
Ozenoxacin"
50083|NCT02090764|E2|Reported Event|Placebo|"Placebo cream
Placebo"
50084|NCT02090764|E1|Reported Event|Ozenoxacin|"ozenoxacin cream 1%
Ozenoxacin"
50085|NCT02090413|B4|Baseline|Total|Total of all reporting groups
50086|NCT02090413|B3|Baseline|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50087|NCT02090413|B2|Baseline|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50088|NCT02090413|B1|Baseline|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50089|NCT02090413|P3|Participant Flow|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50090|NCT02090413|P2|Participant Flow|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50091|NCT02090413|P1|Participant Flow|DMF + ASA-Placebo BID|Dimethyl fumarate (DMF) 120 mg taken twice daily (BID) for the first 7 days and 240 mg BID from Week 2 through Week 48. Acetylsalicylic acid (ASA)-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50092|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50177|NCT02089737|P1|Participant Flow|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
50093|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50094|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50095|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50185|NCT02089347|B1|Baseline|SP306 Group|Participants received SP306 vaccine intramuscularly
50097|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50098|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50099|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50100|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50101|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50102|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50103|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50104|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50105|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50106|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50107|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50108|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50109|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50110|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50111|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50112|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50113|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50114|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50115|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50116|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50117|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50118|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50119|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50120|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50121|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50122|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50123|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50124|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50125|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50126|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50127|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50128|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50129|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50130|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50131|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50132|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50133|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50134|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50135|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50136|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50137|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50138|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50139|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50140|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50141|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50142|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50143|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50178|NCT02089737|O1|Outcome|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
97396|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
50144|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50145|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50146|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50186|NCT02089347|P2|Participant Flow|DT Group|Participants received DT vaccine subcutaneously
50187|NCT02089347|P1|Participant Flow|SP306 Group|Participants received SP306 vaccine intramuscularly
50147|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50148|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50149|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50150|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50151|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50152|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50153|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50154|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50155|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50156|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50157|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50158|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50159|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50160|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50161|NCT02090413|E3|Reported Event|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50162|NCT02090413|E2|Reported Event|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50163|NCT02090413|E1|Reported Event|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
50164|NCT02090088|B1|Baseline|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
50165|NCT02090088|P1|Participant Flow|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
50166|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
50167|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
50168|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
50169|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
50170|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
50171|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
50172|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
50173|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
50174|NCT02090088|E2|Reported Event|Infants|Infants who were born to enrolled participants during the study.
51602|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
50179|NCT02089737|O1|Outcome|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
50180|NCT02089737|O1|Outcome|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
50181|NCT02089737|E2|Reported Event|Concomitant Administration of Panitumumab and Chemotherapy|
50182|NCT02089737|E1|Reported Event|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
50183|NCT02089347|B3|Baseline|Total|Total of all reporting groups
50184|NCT02089347|B2|Baseline|DT Group|Participants received DT vaccine subcutaneously
50191|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
50192|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
50193|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
50194|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
50195|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
50196|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
50197|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
50198|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
50199|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
50200|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
50201|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
50202|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
50203|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
50204|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
50205|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
50206|NCT02089347|E2|Reported Event|DT Group|Participants received DT vaccine subcutaneously
50207|NCT02089347|E1|Reported Event|SP306 Group|Participants received SP306 vaccine intramuscularly
50208|NCT02089191|B1|Baseline|Overall|Nelfilcon A and stenfilcon A contact lenses worn for 12 hours each in Period 1 and 2 as randomized
50209|NCT02089191|P2|Participant Flow|MyDay/DACP|Stenfilcon A contact lenses worn in Period 1, followed by nelfilcon A contact lenses in Period 2
50210|NCT02089191|P1|Participant Flow|DACP/MyDay|Nelfilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses in Period 2
50211|NCT02089191|O2|Outcome|MyDay|Stenfilcon A contact lenses
50212|NCT02089191|O1|Outcome|DACP|Nelfilcon A contact lenses
50213|NCT02089191|O2|Outcome|MyDay|Stenfilcon A contact lenses
50214|NCT02089191|O1|Outcome|DACP|Nelfilcon A contact lenses
50215|NCT02089191|E2|Reported Event|MyDay|Stenfilcon A contact lenses
50216|NCT02089191|E1|Reported Event|DACP|Nelfilcon A contact lenses
50217|NCT02089113|B3|Baseline|Total|Total of all reporting groups
50218|NCT02089113|B2|Baseline|PVPP (Placebo Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing no drug
Punctum Plug"
50219|NCT02089113|B1|Baseline|OTX-DP (Dexamethasone Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing dexamethasone
Dexamethasone"
50220|NCT02089113|P2|Participant Flow|Placebo Vehicle Punctum Plug|No drug treatment
50221|NCT02089113|P1|Participant Flow|Dexamethasone Punctum Plug|Drug treatment
50222|NCT02089113|O2|Outcome|Placebo Vehicle Punctum Plug|No drug treatment
50223|NCT02089113|O1|Outcome|Dexamethasone Punctum Plug|Drug treatment
50224|NCT02089113|E2|Reported Event|Placebo Vehicle Punctum Plug|No drug treatment
50225|NCT02089113|E1|Reported Event|Dexamethasone Punctum Plug|Drug treatment
50226|NCT02088957|B1|Baseline|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50227|NCT02088957|P2|Participant Flow|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50262|NCT02087943|O1|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 30 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 30 mg apremilast tablets twice daily in the active treatment phase.
50263|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
51603|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
50228|NCT02088957|P1|Participant Flow|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50229|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50230|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50231|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50232|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50233|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50234|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50235|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50236|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50237|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50264|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50265|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
50638|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50238|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50239|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50240|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50241|NCT02088957|E2|Reported Event|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50242|NCT02088957|E1|Reported Event|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets."
50243|NCT02088177|B1|Baseline|Open Label Group|open label group receiving injections of long acting naltrexone
50244|NCT02088177|P1|Participant Flow|Open Label Group|open label group receiving injections of long acting naltrexone
50245|NCT02088177|O1|Outcome|Open Label Group|open label group receiving injections of long acting naltrexone
50246|NCT02088177|O1|Outcome|Open Label Group|open label group receiving injections of long acting naltrexone
50247|NCT02088177|E1|Reported Event|Open Label Group|open label group receiving injections of long acting naltrexone
50248|NCT02087995|B1|Baseline|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
50249|NCT02087995|P1|Participant Flow|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
50250|NCT02087995|O1|Outcome|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
50251|NCT02087995|E1|Reported Event|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring System Wear over a 7 day period
50252|NCT02087943|B4|Baseline|Total|Total of all reporting groups
50253|NCT02087943|B3|Baseline|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50254|NCT02087943|B2|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50255|NCT02087943|B1|Baseline|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
50256|NCT02087943|P5|Participant Flow|Placebo/Apremilast 40 mg|Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 40 mg apremilast for 12 weeks, up to week 24.
50257|NCT02087943|P4|Participant Flow|Placebo/Apremilast 30 mg|Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 30 mg apremilast for 12 weeks, up to week 24.
50258|NCT02087943|P3|Participant Flow|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 40 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase.
50259|NCT02087943|P2|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase
50260|NCT02087943|P1|Participant Flow|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
50261|NCT02087943|O2|Outcome|Apremilast 40 mg|Participants initially randomized to 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 40 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment phase, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 40 mg apremilast tablets twice daily in the active treatment phase.
50266|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50267|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50268|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
50269|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50270|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50271|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
50272|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50273|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50644|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50274|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
50275|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50276|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50277|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
50278|NCT02087943|E5|Reported Event|Apremilast 40 mg (Apremilast Exposure Period) 0-24|Participants who received 40 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
50279|NCT02087943|E4|Reported Event|Apremilast 30 mg (Apremilast Exposure Period) 0-24|Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
50280|NCT02087943|E3|Reported Event|Apremilast 40 mg (Weeks 0-12)|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50281|NCT02087943|E2|Reported Event|Apremilast 30 mg (Weeks 0-12)|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
50282|NCT02087943|E1|Reported Event|Placebo (Weeks 0-12)|Participants initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
50283|NCT02087774|B3|Baseline|Total|Total of all reporting groups
50284|NCT02087774|B2|Baseline|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.
The responsibility was given to the principal to implement the program.
Physical Activity and Incentives"
50285|NCT02087774|B1|Baseline|Control School|Control School received no intervention.
50286|NCT02087774|P2|Participant Flow|Intervention Group|"Two schools participated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.
One intervention school implemented the program with responsibility given to the principal (school-wide group) and the other school asked the individual teachers to implement the program daily (classroom based group).
Physical Activity and Incentives"
50287|NCT02087774|P1|Participant Flow|Control School|Control School received no intervention.
50288|NCT02087774|O2|Outcome|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.
The responsibility was given to the principal to implement the program.
Physical Activity and Incentives"
50289|NCT02087774|O1|Outcome|Control School|Control School received no intervention.
50290|NCT02087774|O2|Outcome|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.
The responsibility was given to the principal to implement the program.
Physical Activity and Incentives"
50291|NCT02087774|O1|Outcome|Control School|Control School received no intervention.
50292|NCT02087774|E2|Reported Event|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.
The responsibility was given to the principal to implement the program.
Physical Activity and Incentives"
50293|NCT02087774|E1|Reported Event|Control School|Control School received no intervention.
50294|NCT02087748|B1|Baseline|1% Diclofenac Sodium Gel|Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
50295|NCT02087748|P1|Participant Flow|1% Diclofenac Sodium Gel|Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
50296|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6 hour for 48 hours
Placebo: Placebo gel 4gm applied topically Q6 hour for 48 hours"
50297|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours
1% diclofenac sodium gel: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours"
50298|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6 hour for 48 hours
Placebo: Placebo gel 4gm applied topically Q6 hour for 48 hours"
50299|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours
1% diclofenac sodium gel: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours"
50300|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6H for 48 hours
Placebo: gel manufactured to mimic Diclofenac sodium1% gel"
50301|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours
1% diclofenac sodium gel"
50302|NCT02087748|E2|Reported Event|Placebo|"Placebo gel 4gm applied topically Q6H for 48 hours
Placebo: gel manufactured to mimic Diclofenac sodium1% gel"
50303|NCT02087748|E1|Reported Event|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours
1% diclofenac sodium gel"
50304|NCT02087670|B3|Baseline|Total|Total of all reporting groups
97397|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
50306|NCT02087670|B1|Baseline|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program
controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
50307|NCT02087670|P2|Participant Flow|Community Based Exercise|educational program and not supervises exercise program
50308|NCT02087670|P1|Participant Flow|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program
controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
50309|NCT02087670|O2|Outcome|Community Based Exercise|educational program and not supervises exercise program
50310|NCT02087670|O1|Outcome|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program
controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
50311|NCT02087670|O2|Outcome|Community Based Exercise|educational program and not supervises exercise program
83988|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
50312|NCT02087670|O1|Outcome|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program
controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
50313|NCT02087670|E2|Reported Event|Community Based Exercise|educational program and not supervises exercise program
50314|NCT02087670|E1|Reported Event|Controlled, Supervised Exercise Protocol|controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program
50315|NCT02087241|B5|Baseline|Total|Total of all reporting groups
50316|NCT02087241|B4|Baseline|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
50317|NCT02087241|B3|Baseline|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50318|NCT02087241|B2|Baseline|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
50319|NCT02087241|B1|Baseline|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50320|NCT02087241|P4|Participant Flow|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
50321|NCT02087241|P3|Participant Flow|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50322|NCT02087241|P2|Participant Flow|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
50323|NCT02087241|P1|Participant Flow|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50324|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
50325|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50326|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
50327|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50328|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
50329|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50330|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
50331|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50332|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
50333|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50334|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
50335|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50336|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
50337|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50338|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50339|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
50340|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
50341|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50342|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
50343|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
50344|NCT02087241|E4|Reported Event|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
50345|NCT02087241|E3|Reported Event|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50346|NCT02087241|E2|Reported Event|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
50347|NCT02087241|E1|Reported Event|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
50348|NCT02087176|B1|Baseline|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
50349|NCT02087176|P1|Participant Flow|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
50350|NCT02087176|O1|Outcome|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
50351|NCT02087176|O1|Outcome|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
50352|NCT02087176|E1|Reported Event|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
50353|NCT02087059|B1|Baseline|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
50354|NCT02087059|P1|Participant Flow|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
50355|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
50356|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
50357|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
50358|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
50359|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
50360|NCT02087059|E1|Reported Event|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
50361|NCT02086786|B3|Baseline|Total|Total of all reporting groups
50362|NCT02086786|B2|Baseline|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50363|NCT02086786|B1|Baseline|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50364|NCT02086786|P2|Participant Flow|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50365|NCT02086786|P1|Participant Flow|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50366|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50367|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50368|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50369|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50370|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50371|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50372|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50373|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50374|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50375|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50376|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50377|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50378|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50379|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50380|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50381|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50382|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50383|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50445|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
52329|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%
CD1579 2.5%"
50384|NCT02086786|O2|Outcome|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals."
50385|NCT02086786|O1|Outcome|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals."
50386|NCT02086786|E2|Reported Event|Deltoid (Risperdione ISM)|"Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM"
50387|NCT02086786|E1|Reported Event|Gluteus (Risperidone ISM)|"Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM"
50645|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50388|NCT02086708|B1|Baseline|Shear Wave Sonoelastography, Fibrosis|"Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.
Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy."
50389|NCT02086708|P1|Participant Flow|Shear Wave Sonoelastography, Fibrosis|"Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.
Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy."
50390|NCT02086708|O5|Outcome|Fibrosis 4|Patients with liver biopsy METAVIR stage 4 on pathology evaluation
50391|NCT02086708|O4|Outcome|Fibrosis 3|Patients with liver biopsy METAVIR stage 3 on pathology evaluation
50392|NCT02086708|O3|Outcome|Fibrosis 2|Patients with liver biopsy METAVIR stage 2 on pathology evaluation
50393|NCT02086708|O2|Outcome|Fibrosis 1|Patients with liver biopsy METAVIR stage 1 on pathology evaluation
50394|NCT02086708|O1|Outcome|Fibrosis 0|Patients with no Fibrosis on liver biopsy evaluation
50395|NCT02086708|E5|Reported Event|Fibrosis 4|Patients with liver biopsy METAVIR stage 4 on pathology evaluation
50396|NCT02086708|E4|Reported Event|Fibrosis 3|Patients with liver biopsy METAVIR stage 3 on pathology evaluation
50397|NCT02086708|E3|Reported Event|Fibrosis 2|Patients with liver biopsy METAVIR stage 2 on pathology evaluation
50398|NCT02086708|E2|Reported Event|Fibrosis 1|Patients with liver biopsy METAVIR stage 1 on pathology evaluation
50399|NCT02086708|E1|Reported Event|Fibrosis 0|Patients with no Fibrosis on liver biopsy evaluation
50400|NCT02086591|B1|Baseline|Doxycycline|"Doxycycline 200 mg twice daily
Doxycycline"
50401|NCT02086591|P1|Participant Flow|Doxycycline|"Doxycycline 200 mg twice daily
Doxycycline"
50402|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily
Doxycycline"
50403|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily
Doxycycline"
50404|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily
Doxycycline"
50405|NCT02086591|E1|Reported Event|Doxycycline|"Doxycycline 200 mg twice daily
Doxycycline"
50406|NCT02085785|B3|Baseline|Total|Total of all reporting groups
50407|NCT02085785|B2|Baseline|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
50408|NCT02085785|B1|Baseline|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.
Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
50409|NCT02085785|P2|Participant Flow|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
50410|NCT02085785|P1|Participant Flow|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.
Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
50411|NCT02085785|O2|Outcome|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
50448|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50412|NCT02085785|O1|Outcome|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.
Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
50449|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50646|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50413|NCT02085785|O2|Outcome|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
50414|NCT02085785|O1|Outcome|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.
Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
50415|NCT02085785|O1|Outcome|Self-directed + Coached Combined|Intervention assessment questionnaires were not linked to other study data, so we are unable to report study group information
50416|NCT02085785|O2|Outcome|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
50417|NCT02085785|O1|Outcome|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.
Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
50418|NCT02085785|O1|Outcome|Overall Study Feasibility|Reporting of recruitment and eligibility for the targeted population
50419|NCT02085785|E2|Reported Event|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
50420|NCT02085785|E1|Reported Event|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.
Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
50421|NCT02085720|B1|Baseline|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.
CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
50422|NCT02085720|P1|Participant Flow|Chinese Elderly OSAS|"We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.
CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (ESS), sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
50423|NCT02085720|O1|Outcome|Sleep Heatlh Questionnaire Result|We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres.
50446|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
50447|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
52330|NCT02073461|O3|Outcome|Vehicle|"Vehicle
Vehicle"
50450|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
50451|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50452|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50424|NCT02085720|O1|Outcome|AHI Result|Subjects who had completed the questionnaires and consented for sleep study were invited to undergo a portable at-home sleep study. In the afternoon, subjects attended the pulmonary function laboratory to be fitted with the EmblettaTM portable diagnostic system (PDS, Medcare, Iceland). It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an AHI based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events. Respiratory events were scored when desaturations of at least 4% occurred in the absence of moving artifacts and irrespective of co-existing changes in snoring or heart rate. A hypopnea was defined as a decrease in airflow by 50% of baseline for at least 10 seconds. Data were included in the analysis if the total recorded evaluation time of 4 hrs or longer was obtained during the EmblettaTM PDS study.
50425|NCT02085720|O1|Outcome|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.
CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
50426|NCT02085720|O1|Outcome|Chinese Elderly OSAS|RLS is a disorder characterized by disagreeable leg sensations that usually occur before sleep onset, causing an almost irresistible urge to move the legs. As minimal criteria for diagnosis, the following four features were required: (1) desire to move the extremities, often associated with paresthesias and/or dysesthesias; (2) motor restlessness; (3) worsening of symptoms at rest, with at least temporary relief by activity; and (4) worsening of symptoms in the evening or at night.
50427|NCT02085720|O1|Outcome|Chinese Elderly OSAS|"We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.
CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (ESS), sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
50428|NCT02085720|E1|Reported Event|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.
CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
50429|NCT02085161|B5|Baseline|Total|Total of all reporting groups
50430|NCT02085161|B4|Baseline|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
50431|NCT02085161|B3|Baseline|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50432|NCT02085161|B2|Baseline|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50433|NCT02085161|B1|Baseline|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50434|NCT02085161|P4|Participant Flow|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
50435|NCT02085161|P3|Participant Flow|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50436|NCT02085161|P2|Participant Flow|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50437|NCT02085161|P1|Participant Flow|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50438|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
50439|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50440|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50441|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50442|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
50443|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50444|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50453|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50454|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
50455|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50456|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50457|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50458|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
50459|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50460|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50461|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50462|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
50463|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50464|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50465|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50466|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
50467|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50468|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50469|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50470|NCT02085161|E5|Reported Event|Total|Total
50471|NCT02085161|E4|Reported Event|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
50472|NCT02085161|E3|Reported Event|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50473|NCT02085161|E2|Reported Event|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50474|NCT02085161|E1|Reported Event|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
50475|NCT02084797|B1|Baseline|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.
V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
50487|NCT02084706|O2|Outcome|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects received a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.
2% Lidocaine
Triamcinolone (20 g)
J-tip lidocaine administration
Triamcinolone (20 g) Injection over the A1 pulley."
50476|NCT02084797|P1|Participant Flow|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.
V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
50477|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.
V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
50478|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.
V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
50479|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.
V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
50480|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.
V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
50481|NCT02084797|E1|Reported Event|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.
V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
50482|NCT02084706|B3|Baseline|Total|Total of all reporting groups
50483|NCT02084706|B2|Baseline|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects will receive a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.
2% Lidocaine
Triamcinolone (20 g)
J-tip lidocaine administration
Triamcinolone (20 g) Injection over the A1 pulley."
50484|NCT02084706|B1|Baseline|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.
Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley
2% Lidocaine
Triamcinolone (20 g)"
50485|NCT02084706|P2|Participant Flow|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects will receive a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.
2% Lidocaine
Triamcinolone (20 g)
J-tip lidocaine administration
Triamcinolone (20 g) Injection over the A1 pulley."
50486|NCT02084706|P1|Participant Flow|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.
Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley
2% Lidocaine
Triamcinolone (20 g)"
50488|NCT02084706|O1|Outcome|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects received an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.
Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley
2% Lidocaine
Triamcinolone (20 g)"
50489|NCT02084706|E2|Reported Event|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects received a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.
2% Lidocaine
Triamcinolone (20 g)
J-tip lidocaine administration
Triamcinolone (20 g) Injection over the A1 pulley."
50544|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
51546|NCT02077374|B2|Baseline|Placebo|"Placebo
Matching Placebo BID for 28 days"
50490|NCT02084706|E1|Reported Event|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects received an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.
Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley
2% Lidocaine
Triamcinolone (20 g)"
50491|NCT02084628|B1|Baseline|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50492|NCT02084628|P1|Participant Flow|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participant to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50493|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50494|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50495|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50496|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50497|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50498|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50499|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50500|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50501|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50502|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50503|NCT02084628|E1|Reported Event|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
50504|NCT02084238|B1|Baseline|Interleukin-2|"Interleukin-2 to treat activated SLE.
Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease."
50505|NCT02084238|P1|Participant Flow|Interleukin-2|"Interleukin-2 to treat activated SLE.
Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day break, another cycle started) for 3-6 courses according to the situation of the disease."
50506|NCT02084238|O1|Outcome|SLEDAI Score|SLEDAI score at week 0 and week 10.
50507|NCT02084238|O3|Outcome|Laboratory Variables 3|Serum anti-dsDNA antibodies in patients with SLE
50508|NCT02084238|O2|Outcome|Laboratory Variables 2|Serum complement 4 in SLE patients
50509|NCT02084238|O1|Outcome|Laboratory Variables 1|Serum complement 3 in SLE patients
50510|NCT02084238|O3|Outcome|Immunological Responses 3|Th17 in CD4+T cells in 23 patients with SLE
50511|NCT02084238|O2|Outcome|Immunological Responses 2|Tfh cells in CD4+ T cells in 23 patients with SLE
50512|NCT02084238|O1|Outcome|Immunological Responses 1|Treg in total CD4+T cells in 23 patients with SLE
50513|NCT02084238|O1|Outcome|SRI Results|All 38 patients who completed therapy will be calculated the response rate at each visit time point(week 2,4,6,8,10).
52331|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%
CD1579 5%"
50514|NCT02084238|E1|Reported Event|IL-2 Therapy in SLE|All enrolled patients completed three cycles of recombinant human IL-2 (rhIL-2). In each cycle, 1 million IU rhIL-2 was administered subcutaneously every other day for 2 weeks, followed by a 2-week break.
50515|NCT02084082|B3|Baseline|Total|Total of all reporting groups
50545|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
51547|NCT02077374|B1|Baseline|IDN-6556|"IDN-6556 capsules, 25 mg
IDN-6556: 25 mg BID for 28 days"
50516|NCT02084082|B2|Baseline|FDC 1000 Fed or L+M 1000 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.
FDC 1000 fed (T fed): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
L+M 1000 fed (R fed): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin 1000mg"
50517|NCT02084082|B1|Baseline|FDC 1000 Fast or L+M 1000 Fast|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.
FDC 1000 fast (T fasted): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
L+M 1000 fast (R fasted): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin 1000mg"
50518|NCT02084082|P4|Participant Flow|L+M1000 Fed/ FDC1000 Fed|"Single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR FDC (given as 1 FDC tablet), oral with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin 1000mg"
50519|NCT02084082|P3|Participant Flow|FDC1000 Fed/L+M1000 Fed|"Linagliptin/Metformin XR FDC (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin 1000mg"
50520|NCT02084082|P2|Participant Flow|L+M1000 Fast/ FDC1000 Fast|"Single tablets of linagliptin and metformin Extended Release (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR Fixed Dose Combination (given as 1 FDC tablet), oral with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin 1000mg"
50521|NCT02084082|P1|Participant Flow|FDC 1000 Fast/ L+M 1000 Fast|"Linagliptin/Metformin Extended Release (XR) Fixed dose combination (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin 1000mg"
50522|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
50523|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
50524|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
50525|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
50526|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
50527|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
50528|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
50529|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
50530|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
50531|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
50532|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
50533|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
50534|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
50535|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
50536|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
50537|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
50538|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
50539|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
50540|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
50541|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
50542|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
50543|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
50639|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50546|NCT02084082|E4|Reported Event|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
50547|NCT02084082|E3|Reported Event|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
50548|NCT02084082|E2|Reported Event|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
50549|NCT02084082|E1|Reported Event|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
50550|NCT02084069|B3|Baseline|Total|Total of all reporting groups
50551|NCT02084069|B2|Baseline|Control|Placebo
50552|NCT02084069|B1|Baseline|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
50553|NCT02084069|P2|Participant Flow|Control|Placebo
50554|NCT02084069|P1|Participant Flow|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
50555|NCT02084069|O2|Outcome|Control|Placebo
50556|NCT02084069|O1|Outcome|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
50557|NCT02084069|E2|Reported Event|Control|Placebo
50558|NCT02084069|E1|Reported Event|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
50559|NCT02084056|B3|Baseline|Total|Total of all reporting groups
50560|NCT02084056|B2|Baseline|FDC 2000 Fed or L+M 2000 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.
FDC 2000 fed (T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after a high-fat, high-calorie meal.
L+M 2000 fed (R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
50561|NCT02084056|B1|Baseline|FDC 2000 Fasted or L+M 2000 Fasted|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.
FDC 2000 fasted (T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
L+M 2000 fasted (R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
50562|NCT02084056|P4|Participant Flow|L+M 2000 Fed / FDC 2000 Fed|"Linagliptin+ Metformin-(R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
50563|NCT02084056|P3|Participant Flow|FDC 2000 Fed / L+M 2000 Fed|"Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
50564|NCT02084056|P2|Participant Flow|L+M 2000 Fasted / FDC 2000 Fasted|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
50565|NCT02084056|P1|Participant Flow|FDC 2000 Fasted / L+M 2000 Fasted|"Linagliptin+ Metformin Fixed dose combination (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin Extended Release (XR) (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
50566|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
50567|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
50568|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
50569|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
50570|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
50571|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
50572|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
50573|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
52332|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%
CD1579 2.5%"
50574|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
50575|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
50640|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50576|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
50577|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
50578|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
50579|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
50580|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
50581|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
50582|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
50583|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
50584|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
50585|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
50586|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
50587|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
50588|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
50589|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
50590|NCT02084056|E4|Reported Event|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
50591|NCT02084056|E3|Reported Event|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
50592|NCT02084056|E2|Reported Event|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
50593|NCT02084056|E1|Reported Event|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
50594|NCT02083965|B3|Baseline|Total|Total of all reporting groups
50595|NCT02083965|B2|Baseline|rFVIIIFc 3000 / 1000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 3000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.
After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:
A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.
A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.
An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
50596|NCT02083965|B1|Baseline|rFVIIIFc 1000 / 3000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 1000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.
After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:
A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.
A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.
An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
50633|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50634|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50635|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50636|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|rFVIIIFc single injection 50 IU/kg at a strength of 3000 IU/vial
50637|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50641|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50642|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50643|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50597|NCT02083965|P2|Participant Flow|rFVIIIFc 3000 / 1000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 3000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.
After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:
A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.
A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.
An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
50598|NCT02083965|P1|Participant Flow|rFVIIIFc 1000 / 3000|"Following a minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 1000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of pharmacokinetic (PK) assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at strength of 3000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.
After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:
A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.
A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.
An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
50599|NCT02083965|O1|Outcome|rFVIIIFc|"Following the minimum 4-day washout, participants received their first injection of rFVIIIFc (on Injection 1 Day 1) rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial. The second injection of rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial was administered, in a crossover fashion, after a minimum of a 5-day washout (on Injection 2 Day 1).
After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:
A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.
A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate participants who were selected based on the opinion of the Investigator.
An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
50600|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50601|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50602|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50603|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50604|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50605|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50606|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50607|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50608|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50609|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50610|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50611|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50612|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50613|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50614|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50615|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50616|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50617|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50618|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50619|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50620|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50621|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50622|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50623|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50624|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50625|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50626|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50627|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50628|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50629|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50630|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50631|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50632|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50647|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50648|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50649|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50650|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
50651|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
50652|NCT02083965|E1|Reported Event|Total Active|"Following the minimum 4-day washout, participants received their first injection of rFVIIIFc (on Injection 1 Day 1) rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial. The second injection of rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial was administered, in a crossover fashion, after a minimum of a 5-day washout (on Injection 2 Day 1).
After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:
A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.
A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate participants who were selected based on the opinion of the Investigator.
An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
50653|NCT02083679|B5|Baseline|Total|Total of all reporting groups
50654|NCT02083679|B4|Baseline|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50655|NCT02083679|B3|Baseline|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50656|NCT02083679|B2|Baseline|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50657|NCT02083679|B1|Baseline|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50658|NCT02083679|P4|Participant Flow|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50659|NCT02083679|P3|Participant Flow|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50660|NCT02083679|P2|Participant Flow|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50661|NCT02083679|P1|Participant Flow|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50662|NCT02083679|O4|Outcome|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50680|NCT02083406|P1|Participant Flow|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
50681|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
50682|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
50663|NCT02083679|O3|Outcome|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50664|NCT02083679|O2|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50665|NCT02083679|O1|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50666|NCT02083679|O4|Outcome|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50667|NCT02083679|O3|Outcome|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50668|NCT02083679|O2|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50669|NCT02083679|O1|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50670|NCT02083679|E4|Reported Event|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50671|NCT02083679|E3|Reported Event|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50672|NCT02083679|E2|Reported Event|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50673|NCT02083679|E1|Reported Event|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
50674|NCT02083406|B4|Baseline|Total|Total of all reporting groups
50675|NCT02083406|B3|Baseline|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
50676|NCT02083406|B2|Baseline|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
52333|NCT02073461|O3|Outcome|Vehicle|"Vehicle
Vehicle"
50677|NCT02083406|B1|Baseline|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
50678|NCT02083406|P3|Participant Flow|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
50679|NCT02083406|P2|Participant Flow|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
83989|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
50683|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
50684|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
50685|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
50686|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
50687|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
50688|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
50689|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
50690|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
50691|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
50692|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
50693|NCT02083406|E3|Reported Event|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
50694|NCT02083406|E2|Reported Event|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
50695|NCT02083406|E1|Reported Event|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
50696|NCT02083380|B4|Baseline|Total|Total of all reporting groups
50697|NCT02083380|B3|Baseline|C) Artefenomel 800mg: PQP 1440mg|Artefenomel 800mg: Piperaquine 1440mg
50698|NCT02083380|B2|Baseline|B) Artefenomel 800mg: PQP 960mg|Artefenomel 800mg: Piperaquine 960mg
50699|NCT02083380|B1|Baseline|A) Artefenomel 800mg: PQP 640mg|Artefenomel 800mg: Piperaquine 640mg
50700|NCT02083380|P3|Participant Flow|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50701|NCT02083380|P2|Participant Flow|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50702|NCT02083380|P1|Participant Flow|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50703|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
50704|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
50705|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
50706|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|"Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
Artefenomel 800mg: PQP 640mg, 960mg & 1440mg"
50707|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50708|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50709|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50710|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50711|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50712|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50713|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50714|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50715|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50716|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50717|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50718|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50719|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50720|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50721|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50722|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50723|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50724|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50725|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50726|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50727|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50728|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50729|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50730|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
83990|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
50731|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50732|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50733|NCT02083380|O1|Outcome|A) Arttefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50734|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50735|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50736|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50737|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50738|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50739|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50740|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50741|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50742|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50743|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50744|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50745|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50746|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50747|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50748|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50749|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50750|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50751|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50752|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50753|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50754|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50755|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50756|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50757|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50758|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50759|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50760|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50761|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|C) Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50762|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50763|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50764|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50765|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50766|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50767|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50768|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50769|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50770|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50771|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50772|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50773|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
52334|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%
CD1579 5%"
50774|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50775|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50776|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50777|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50778|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50779|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50780|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50781|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50782|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50783|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50784|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50785|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50786|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50787|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
50788|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
50789|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
50790|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: piperaquine 640mg: Active, loose combination
50791|NCT02083380|E3|Reported Event|C) Artefenomel 800mg: PQP 1440mg|Artefenomel 800mg: Piperaquine 1440mg
50792|NCT02083380|E2|Reported Event|B) Artefenomel 800mg: PQP 960mg|Artefenomel 800mg: Piperaquine 960mg
50793|NCT02083380|E1|Reported Event|A) Artefenomel 800mg: PQP 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg
50794|NCT02083263|B3|Baseline|Total|Total of all reporting groups
50795|NCT02083263|B2|Baseline|PEP Mask|"PEP mask, 3 months
PEP mask: 3 months"
50796|NCT02083263|B1|Baseline|Bilevel|"Bilevel, 3 months
Bilevel: 3 months"
50797|NCT02083263|P2|Participant Flow|PEP Mask|"PEP mask, 3 months
PEP mask: 3 months"
50798|NCT02083263|P1|Participant Flow|Bilevel|"Bilevel, 3 months
Bilevel: 3 months"
50799|NCT02083263|O2|Outcome|PEP Mask|"PEP mask, 3 months
PEP mask: 3 months"
50800|NCT02083263|O1|Outcome|Bilevel|"Bilevel, 3 months
Bilevel: 3 months"
50801|NCT02083263|E2|Reported Event|PEP Mask|"PEP mask, 3 months
PEP mask: 3 months"
50802|NCT02083263|E1|Reported Event|Bilevel|"Bilevel, 3 months
Bilevel: 3 months"
50803|NCT02083107|B4|Baseline|Total|Total of all reporting groups
50804|NCT02083107|B3|Baseline|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50805|NCT02083107|B2|Baseline|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50806|NCT02083107|B1|Baseline|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50807|NCT02083107|P3|Participant Flow|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50808|NCT02083107|P2|Participant Flow|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50809|NCT02083107|P1|Participant Flow|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50810|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50811|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50812|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50813|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50814|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50815|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50816|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50817|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50818|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50819|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50820|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50821|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50861|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat"
51548|NCT02077374|P2|Participant Flow|Placebo|"Placebo
Matching Placebo BID for 28 days"
50822|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50823|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50824|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50825|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50826|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50827|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50828|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50829|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50830|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50831|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50832|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50833|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50834|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50835|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50836|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50837|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50838|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50839|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50840|NCT02083107|E3|Reported Event|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50841|NCT02083107|E2|Reported Event|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
50842|NCT02083107|E1|Reported Event|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
50843|NCT02082912|B3|Baseline|Total|Total of all reporting groups
50844|NCT02082912|B2|Baseline|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
50845|NCT02082912|B1|Baseline|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
50846|NCT02082912|P2|Participant Flow|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
50847|NCT02082912|P1|Participant Flow|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
50848|NCT02082912|O2|Outcome|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
50849|NCT02082912|O1|Outcome|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
50850|NCT02082912|E2|Reported Event|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
50851|NCT02082912|E1|Reported Event|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
50852|NCT02082769|B4|Baseline|Total|Total of all reporting groups
50853|NCT02082769|B3|Baseline|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol"
50854|NCT02082769|B2|Baseline|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat"
50855|NCT02082769|B1|Baseline|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat"
52335|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%
CD1579 2.5%"
50856|NCT02082769|P3|Participant Flow|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol"
50857|NCT02082769|P2|Participant Flow|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat"
50858|NCT02082769|P1|Participant Flow|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat"
50859|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol"
50860|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat"
50862|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol"
50863|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat"
50864|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat"
50865|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol"
50866|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat"
50867|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat"
50868|NCT02082769|E3|Reported Event|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol"
50869|NCT02082769|E2|Reported Event|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat"
50870|NCT02082769|E1|Reported Event|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat"
50871|NCT02082392|B3|Baseline|Total|Total of all reporting groups
50872|NCT02082392|B2|Baseline|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50873|NCT02082392|B1|Baseline|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50874|NCT02082392|P2|Participant Flow|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50875|NCT02082392|P1|Participant Flow|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50876|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50877|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50878|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50879|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50880|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50881|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50882|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50883|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50884|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50885|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50886|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50887|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50888|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50889|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50890|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50891|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50892|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50893|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50894|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
51271|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
50895|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50896|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50897|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50898|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50899|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50900|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50901|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50902|NCT02082392|O2|Outcome|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50903|NCT02082392|O1|Outcome|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50904|NCT02082392|E2|Reported Event|Research Frequency Management|"Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Escitalopram"
50905|NCT02082392|E1|Reported Event|Clinical Frequency Management|"Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Escitalopram"
50906|NCT02082288|B1|Baseline|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:
Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
50907|NCT02082288|P1|Participant Flow|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:
Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
50908|NCT02082288|O1|Outcome|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:
Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
50909|NCT02082288|E1|Reported Event|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:
Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
50910|NCT02082262|B1|Baseline|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
50911|NCT02082262|P1|Participant Flow|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
50912|NCT02082262|O1|Outcome|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
50913|NCT02082262|E1|Reported Event|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
50914|NCT02082184|B3|Baseline|Total|Total of all reporting groups
50915|NCT02082184|B2|Baseline|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50916|NCT02082184|B1|Baseline|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50942|NCT02082158|B1|Baseline|Local Respirator Model|"Subjects randomized to a current respirator model will wear that model while participating in study activities.
Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
51004|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
50917|NCT02082184|P2|Participant Flow|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
51549|NCT02077374|P1|Participant Flow|IDN-6556|"IDN-6556 capsules, 25 mg
IDN-6556: 25 mg BID for 28 days"
50918|NCT02082184|P1|Participant Flow|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50919|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50920|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50921|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50922|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50923|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50924|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50925|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50926|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50927|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50943|NCT02082158|P6|Participant Flow|Prototype 4 Respirator Design|"Subjects randomized to Prototype 4 respirator design will wear that model while participating in study activities.
Prototype 4 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
51005|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
50928|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
83991|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
50929|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50930|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50931|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50932|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50933|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50934|NCT02082184|E2|Reported Event|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50935|NCT02082184|E1|Reported Event|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
50936|NCT02082158|B7|Baseline|Total|Total of all reporting groups
50937|NCT02082158|B6|Baseline|Prototype 4 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.
Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50938|NCT02082158|B5|Baseline|Prototype 3 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.
Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50939|NCT02082158|B4|Baseline|Prototype 2 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.
Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50940|NCT02082158|B3|Baseline|Prototype 1 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.
Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50941|NCT02082158|B2|Baseline|Non-Local Respirator Model|"Subjects randomized to a current respirator design will wear that model while participating in study activities.
Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50962|NCT02082158|E5|Reported Event|Prototype 3 Respirator Design|Subjects randomized to Prototype 3 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
50944|NCT02082158|P5|Participant Flow|Prototype 3 Respirator Design|"Subjects randomized to Prototype 3 respirator design will wear that model while participating in study activities.
Prototype 3 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
51008|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51550|NCT02077374|O2|Outcome|Placebo|"Placebo
Placebo: Placebo BID for 28 Days"
50945|NCT02082158|P4|Participant Flow|Prototype 2 Respirator Design|"Subjects randomized to Prototype 2 respirator design will wear that model while participating in study activities.
Prototype 2 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50946|NCT02082158|P3|Participant Flow|Prototype 1 Respirator Design|"Subjects randomized to Prototype 1 respirator design will wear that model while participating in study activities.
Prototype 1 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50947|NCT02082158|P2|Participant Flow|Non-Local Respirator Model|"Subjects randomized to the non-local respirator design will wear that model while participating in study activities.
Non-Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.
Novel Respirator Design"
50948|NCT02082158|P1|Participant Flow|Local Respirator Model|"Subjects randomized to the local respirator model will wear that model while participating in study activities.
Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.
Novel Respirator Design"
50949|NCT02082158|O6|Outcome|Prototype 4 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.
Prototype 4 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50950|NCT02082158|O5|Outcome|Prototype 3 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.
Prototype 3 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50951|NCT02082158|O4|Outcome|Prototype 2 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.
Prototype 2 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50952|NCT02082158|O3|Outcome|Prototype 1 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.
Prototype 1 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50953|NCT02082158|O2|Outcome|Non-Local Respirator Model|"Subjects randomized to a non-local respirator model will wear that model while participating in study activities.
Non-Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.
Novel Respirator Design"
50954|NCT02082158|O1|Outcome|Local Respirator Model|"Subjects randomized to a current respirator model will wear that model while participating in study activities.
Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.
Novel Respirator Design"
50955|NCT02082158|O6|Outcome|Prototype 4 Respirator Design|"Subjects randomized to the Prototype 4 respirator design will wear that respirator while participating in study activities.
Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50956|NCT02082158|O5|Outcome|Prototype 3 Respirator Design|"Subjects randomized to the Prototype 3 respirator design will wear that respirator while participating in study activities.
Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50957|NCT02082158|O4|Outcome|Prototype 2 Respirator Design|"Subjects randomized to the Prototype 2 respirator design will wear that respirator while participating in study activities.
Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50958|NCT02082158|O3|Outcome|Prototype 1 Respirator Design|"Subjects randomized to the Prototype 1 respirator design will wear that respirator while participating in study activities.
Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50959|NCT02082158|O2|Outcome|Non-Local Respirator Model|"Subjects randomized to the non-local respirator model will wear that model while participating in study activities.
Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50960|NCT02082158|O1|Outcome|Local Respirator Model|"Subjects randomized to the local respirator model will wear that model while participating in study activities.
Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
50961|NCT02082158|E6|Reported Event|Prototype 4 Respirator Design|Subjects randomized to Prototype 4 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
52336|NCT02073461|O3|Outcome|Vehicle|"Vehicle
Vehicle"
50963|NCT02082158|E4|Reported Event|Prototype 2 Respirator Design|Subjects randomized to Prototype 2 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
51272|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
50964|NCT02082158|E3|Reported Event|Prototype 1 Respirator Design|Subjects randomized to Prototype 1 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
50965|NCT02082158|E2|Reported Event|Non-Local Respirator Model|Subjects randomized to the non-local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
50966|NCT02082158|E1|Reported Event|Local Respirator Model|Subjects randomized to the local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
50967|NCT02081859|B3|Baseline|Total|Total of all reporting groups
50968|NCT02081859|B2|Baseline|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.
Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
50969|NCT02081859|B1|Baseline|Conventional Grading|"Embryos will be scored based on conventional criteria.
Conventional Criteria"
50970|NCT02081859|P2|Participant Flow|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.
Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
50971|NCT02081859|P1|Participant Flow|Conventional Grading|"Embryos will be scored based on conventional criteria.
Conventional Criteria"
50972|NCT02081859|O2|Outcome|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.
Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
50973|NCT02081859|O1|Outcome|Conventional Grading|"Embryos will be scored based on conventional criteria.
Conventional Criteria"
50974|NCT02081859|O2|Outcome|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.
Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
50975|NCT02081859|O1|Outcome|Conventional Grading|"Embryos will be scored based on conventional criteria.
Conventional Criteria"
50976|NCT02081859|E2|Reported Event|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.
Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
50977|NCT02081859|E1|Reported Event|Conventional Grading|"Embryos will be scored based on conventional criteria.
Conventional Criteria"
50978|NCT02081677|B5|Baseline|Total|Total of all reporting groups
50979|NCT02081677|B4|Baseline|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
50980|NCT02081677|B3|Baseline|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
50981|NCT02081677|B2|Baseline|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
50982|NCT02081677|B1|Baseline|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
50983|NCT02081677|P4|Participant Flow|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
50984|NCT02081677|P3|Participant Flow|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
50985|NCT02081677|P2|Participant Flow|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
50986|NCT02081677|P1|Participant Flow|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
50987|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
50988|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
50989|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
50990|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
50991|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
50992|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
50993|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
50994|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
50995|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
50996|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
50997|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
50998|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
50999|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51000|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51001|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51002|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51003|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
52337|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%
CD1579 5%"
51006|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51007|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51009|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51010|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51011|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51012|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51013|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51014|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51015|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51016|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51017|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51018|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51019|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51020|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51021|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51022|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51023|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51024|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51025|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51026|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51027|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51028|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51029|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51030|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51031|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51032|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51033|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51034|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51035|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51036|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51037|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51038|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51039|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51040|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51041|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51042|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51043|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51044|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51045|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51046|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51047|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51048|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51049|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51050|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51051|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51052|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51053|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51054|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51055|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51056|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51057|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51058|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51059|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51060|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51061|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51062|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51063|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51064|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51065|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51066|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51067|NCT02081677|O4|Outcome|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51068|NCT02081677|O3|Outcome|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51069|NCT02081677|O2|Outcome|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51070|NCT02081677|O1|Outcome|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51071|NCT02081677|E4|Reported Event|Prototype E3|Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
51072|NCT02081677|E3|Reported Event|Prototype E2|Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
51073|NCT02081677|E2|Reported Event|Prototype E1|Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
51074|NCT02081677|E1|Reported Event|Etafilcon A|Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
51075|NCT02081599|B3|Baseline|Total|Total of all reporting groups
51076|NCT02081599|B2|Baseline|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51077|NCT02081599|B1|Baseline|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51078|NCT02081599|P2|Participant Flow|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51079|NCT02081599|P1|Participant Flow|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51080|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51081|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51082|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51083|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51084|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51085|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51086|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51087|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
51268|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51088|NCT02081599|E4|Reported Event|Teneli (Teneligliptin) /Teneli + Insulin(Data Through Week 52)|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 52 were shown.
51551|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg
IDN-6556: 25 mg BID for 28 days"
51089|NCT02081599|E3|Reported Event|Placebo/Teneli(Teneligliptin)+Insulin(Data From Week 16 to 52)|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 16 to Week 52 were shown.
51090|NCT02081599|E2|Reported Event|Teneli (Teneligliptin)/Teneli + Insulin(Data Through Week 16)|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
51091|NCT02081599|E1|Reported Event|Placebo/Teneli (Teneligliptin) + Insulin(Data Through Week 16)|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
51092|NCT02081586|B5|Baseline|Total|Total of all reporting groups
51093|NCT02081586|B4|Baseline|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51094|NCT02081586|B3|Baseline|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51095|NCT02081586|B2|Baseline|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51096|NCT02081586|B1|Baseline|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51097|NCT02081586|P4|Participant Flow|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51098|NCT02081586|P3|Participant Flow|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51099|NCT02081586|P2|Participant Flow|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51100|NCT02081586|P1|Participant Flow|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51101|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51102|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51131|NCT02081443|O2|Outcome|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
51133|NCT02081443|O2|Outcome|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
51552|NCT02077374|O2|Outcome|Placebo|"Placebo
Matching Placebo BID for 28 days"
51103|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51104|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51105|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51106|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51107|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51108|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51109|NCT02081586|O4|Outcome|Standard Diabetes Care at PCP|"Patients will remain in usual care and not receive study intervention. This will include usual diabetes care at PCP.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51110|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51111|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51112|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51113|NCT02081586|O5|Outcome|Participants Administered Phone CBT|This includes the 3 treatment arms who received Phone CBT, whether CBT treatment was 6, 8, or 12 weeks long.
51114|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51115|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51132|NCT02081443|O1|Outcome|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
51269|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51116|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51117|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51118|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51119|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51120|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51121|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51122|NCT02081586|E4|Reported Event|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51123|NCT02081586|E3|Reported Event|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51124|NCT02081586|E2|Reported Event|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51125|NCT02081586|E1|Reported Event|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
51126|NCT02081443|B3|Baseline|Total|Total of all reporting groups
51127|NCT02081443|B2|Baseline|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
51128|NCT02081443|B1|Baseline|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
51129|NCT02081443|P2|Participant Flow|Ticagrelor 90mg|The proposed study has a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays were done following in vitro incubation with and without 500 nM cangrelor.
51130|NCT02081443|P1|Participant Flow|Ticagrelor 180mg|The proposed study have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays was done following in vitro incubation with and without 500 nM cangrelor.
52338|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%
CD1579 2.5%"
51134|NCT02081443|O1|Outcome|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
51135|NCT02081443|O2|Outcome|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
51136|NCT02081443|O1|Outcome|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
51137|NCT02081443|E2|Reported Event|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
51138|NCT02081443|E1|Reported Event|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
51139|NCT02081365|B3|Baseline|Total|Total of all reporting groups
51140|NCT02081365|B2|Baseline|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51141|NCT02081365|B1|Baseline|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).
The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51142|NCT02081365|P2|Participant Flow|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51143|NCT02081365|P1|Participant Flow|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).
The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51144|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51145|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).
The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51146|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51147|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).
The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51177|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
51178|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
51181|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
51273|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51148|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51149|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).
The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51150|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51151|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).
The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51152|NCT02081365|E2|Reported Event|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51153|NCT02081365|E1|Reported Event|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).
The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.
One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
51154|NCT02081183|B3|Baseline|Total|Total of all reporting groups
51155|NCT02081183|B2|Baseline|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51156|NCT02081183|B1|Baseline|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51157|NCT02081183|P2|Participant Flow|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51158|NCT02081183|P1|Participant Flow|Mycophenolate Mofetil (MMF), Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m^2), intravenously (IV) once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), tablets (or methylprednisolone IV), orally (PO); the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51159|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51179|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
51180|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
51160|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51161|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51162|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51163|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51164|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51165|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51166|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51167|NCT02081183|E2|Reported Event|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51168|NCT02081183|E1|Reported Event|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.
Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
51169|NCT02081079|B5|Baseline|Total|Total of all reporting groups
51170|NCT02081079|B4|Baseline|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
51171|NCT02081079|B3|Baseline|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
51172|NCT02081079|B2|Baseline|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
51173|NCT02081079|B1|Baseline|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
51174|NCT02081079|P2|Participant Flow|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
51175|NCT02081079|P1|Participant Flow|Genotype 4|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily for up to 12 weeks in participants with genotype 4 hepatitis C virus (HCV) infection
51176|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
52339|NCT02073461|E3|Reported Event|Vehicle|"Vehicle
Vehicle"
51182|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
51183|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
51184|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
51185|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
51186|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
51187|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
51188|NCT02081079|O2|Outcome|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
51189|NCT02081079|O1|Outcome|Genotype 4|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
51190|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
51191|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
51192|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
51193|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
51194|NCT02081079|E2|Reported Event|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
51195|NCT02081079|E1|Reported Event|Genotype 4|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
51196|NCT02081014|B1|Baseline|Total Study Group|Includes all 12 treated subjects
51197|NCT02081014|P6|Participant Flow|G-Pen Mini™ Dose Order: 300, 150 & 75 Micrograms|G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 75 ug SC injections at treatment visit 3.
51198|NCT02081014|P5|Participant Flow|G-Pen Mini™ Dose Order: 300, 75 & 150 Micrograms|G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
51199|NCT02081014|P4|Participant Flow|G-Pen Mini™ Dose Order: 150, 300 & 75 Micrograms|G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
51200|NCT02081014|P3|Participant Flow|G-Pen Mini™ Dose Order: 150, 75 & 300 Micrograms|G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
51201|NCT02081014|P2|Participant Flow|G-Pen Mini™ Dose Order: 75, 300 & 150 Micrograms|G-Pen Mini™ (glucagon injection): two 75 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
51202|NCT02081014|P1|Participant Flow|G-Pen Mini™ Dose Order: 75, 150 & 300 Micrograms|G-Pen Mini™ (glucagon injection): two 75 microgram (ug) subcutaneous (SC) injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
51203|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51204|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51205|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51206|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given fo subjects following an overnight fast
51207|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given fo subjects following an overnight fast
51208|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given fo subjects following an overnight fast
51209|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51210|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51211|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51267|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51212|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
51213|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
51214|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
51215|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51216|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51217|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51218|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
51219|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
51220|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
51221|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51222|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51223|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51224|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given fo subjects following an overnight fast
51225|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given fo subjects following an overnight fast
51226|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given fo subjects following an overnight fast
51227|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51228|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51229|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51230|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
51231|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
51232|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
51233|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51234|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51235|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
51236|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
51237|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
51238|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
51239|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
51240|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
51241|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
51242|NCT02081014|E3|Reported Event|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
51243|NCT02081014|E2|Reported Event|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
51244|NCT02081014|E1|Reported Event|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
51245|NCT02081001|B3|Baseline|Total|Total of all reporting groups
51246|NCT02081001|B2|Baseline|GlucaGen First, Followed by Xeris G-Pump|Subjects who received GlucaGen at the first treatment visit and G-Pump (glucagon infusion) at the second treatment visit.
51247|NCT02081001|B1|Baseline|Xeris G-Pump Glucagon First, Followed by GlucaGen|Subjects who received G-Pump (glucagon infusion) at the first treatment visit and GlucaGen at the second treatment visit.
51270|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
83992|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
51248|NCT02081001|P12|Participant Flow|Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
51249|NCT02081001|P11|Participant Flow|Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
51250|NCT02081001|P10|Participant Flow|Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
51251|NCT02081001|P9|Participant Flow|Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
51252|NCT02081001|P8|Participant Flow|Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
51253|NCT02081001|P7|Participant Flow|Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
51254|NCT02081001|P6|Participant Flow|Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
51255|NCT02081001|P5|Participant Flow|Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
51256|NCT02081001|P4|Participant Flow|Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
51257|NCT02081001|P3|Participant Flow|Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
51258|NCT02081001|P2|Participant Flow|Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
51259|NCT02081001|P1|Participant Flow|Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
51260|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51261|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51262|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51263|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51264|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51265|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51266|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51274|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51275|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51276|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51277|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51278|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51279|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51280|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51281|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51282|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51283|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51284|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51285|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51286|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51287|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51288|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51289|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51290|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51291|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51292|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51293|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51294|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51295|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51296|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51297|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51298|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51299|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51300|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51301|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51302|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51303|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51304|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51305|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51306|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51307|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51308|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51309|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51310|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51311|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51312|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51313|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51314|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51315|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51316|NCT02081001|O4|Outcome|0.3μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
51317|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51318|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51319|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
51320|NCT02081001|E2|Reported Event|Novo Nordisk GlucaGen®|Novo Nordisk GlucaGen®; single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg delivered by infusion pump
52340|NCT02073461|E2|Reported Event|CD1579 5%|"Benzoyl Peroxide 5%
CD1579 5%"
51321|NCT02081001|E1|Reported Event|G-Pump™ (Glucagon Infusion)|G-Pump™ (glucagon infusion); single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg delivered via infusion pump
51343|NCT02080507|P2|Participant Flow|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
83993|NCT01877720|E2|Reported Event|NIV-PS|non-invasive PS
51322|NCT02080780|B1|Baseline|2% Diltiazem & Clarithromycin XL|"3 parts:
- Diltiazem Single Dose
- Clarithromycin XL (Days 4-9)
- Diltiazem Single Dose after Clarithromycin
Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)"
51323|NCT02080780|P1|Participant Flow|2% Diltiazem & Clarithromycin XL|"3 parts:
- Diltiazem Single Dose
- Clarithromycin XL (Days 4-9)
- Diltiazem Single Dose after Clarithromycin
Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)"
51324|NCT02080780|O2|Outcome|Diltiazem Single Dose After Clarithromycin|2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
51325|NCT02080780|O1|Outcome|Diltiazem Single Dose|On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg)
51326|NCT02080780|E3|Reported Event|Diltiazem Single Dose After Clarithromycin|2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
51327|NCT02080780|E2|Reported Event|Clarithromycin XL (Days 4-9)|On Days 4 through 9, subjects received once daily doses of clarithromycin XL (2 tablets, 500 mg/tablet, total dose = 1000 mg/day; 6000 mg total in 6 days) with 24 hours between doses.
51328|NCT02080780|E1|Reported Event|Diltiazem Single Dose|On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg)
51329|NCT02080546|B3|Baseline|Total|Total of all reporting groups
51330|NCT02080546|B2|Baseline|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
51331|NCT02080546|B1|Baseline|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
51332|NCT02080546|P2|Participant Flow|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
51333|NCT02080546|P1|Participant Flow|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
51334|NCT02080546|O2|Outcome|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
51335|NCT02080546|O1|Outcome|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
51336|NCT02080546|O2|Outcome|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
51337|NCT02080546|O1|Outcome|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
51338|NCT02080546|E2|Reported Event|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
51339|NCT02080546|E1|Reported Event|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
51340|NCT02080507|B3|Baseline|Total|Total of all reporting groups
51341|NCT02080507|B2|Baseline|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
51342|NCT02080507|B1|Baseline|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
52341|NCT02073461|E1|Reported Event|CD1579 2.5%|"Benzoyl Peroxide 2.5%
CD1579 2.5%"
51456|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51344|NCT02080507|P1|Participant Flow|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
51345|NCT02080507|O2|Outcome|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
51346|NCT02080507|O1|Outcome|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
51347|NCT02080507|O2|Outcome|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
51348|NCT02080507|O1|Outcome|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
51349|NCT02080507|E2|Reported Event|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
51350|NCT02080507|E1|Reported Event|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
51351|NCT02080481|B3|Baseline|Total|Total of all reporting groups
51352|NCT02080481|B2|Baseline|Conventional Block Needle|"ultrasound guidance with a conventional block needle
Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
51353|NCT02080481|B1|Baseline|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system
Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
51354|NCT02080481|P2|Participant Flow|Conventional Block Needle|"ultrasound guidance with a conventional block needle
Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
51355|NCT02080481|P1|Participant Flow|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system
Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
51356|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle
Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
51357|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system
Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
51358|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle
Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
51359|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system
Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
51360|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle
Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
51361|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system
Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
51362|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle
Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
51363|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system
Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
51364|NCT02080481|E2|Reported Event|Conventional Block Needle|"ultrasound guidance with a conventional block needle
Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
51365|NCT02080481|E1|Reported Event|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system
Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
51366|NCT02080312|B1|Baseline|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
Magnevist (gadopentetate dimeglumine)"
51367|NCT02080312|P1|Participant Flow|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
Magnevist (gadopentetate dimeglumine)"
51368|NCT02080312|O1|Outcome|Intratympanic Injection|Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
51419|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51421|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51369|NCT02080312|O1|Outcome|Intratympanic Injection|Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
51370|NCT02080312|O1|Outcome|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
Magnevist (gadopentetate dimeglumine)"
51371|NCT02080312|E1|Reported Event|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
Magnevist (gadopentetate dimeglumine)"
51372|NCT02080091|B1|Baseline|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
51373|NCT02080091|P1|Participant Flow|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
51374|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
51375|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
51376|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
51377|NCT02080091|E1|Reported Event|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
51378|NCT02079844|B4|Baseline|Total|Total of all reporting groups
51379|NCT02079844|B3|Baseline|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51380|NCT02079844|B2|Baseline|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51381|NCT02079844|B1|Baseline|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51382|NCT02079844|P3|Participant Flow|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51383|NCT02079844|P2|Participant Flow|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51384|NCT02079844|P1|Participant Flow|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51385|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51386|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51387|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51388|NCT02079844|O3|Outcome|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51389|NCT02079844|O2|Outcome|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51420|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51390|NCT02079844|O1|Outcome|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51391|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51392|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51393|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51394|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51395|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51396|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51397|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51398|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51399|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51400|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51401|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51402|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51403|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51404|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51405|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51406|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51407|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51408|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51409|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51410|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51411|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51412|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51413|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51414|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51415|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51416|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51417|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51418|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51422|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51423|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51424|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51425|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51426|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51427|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51428|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51429|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51430|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51431|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51432|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51433|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51434|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51435|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51436|NCT02079844|E3|Reported Event|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51437|NCT02079844|E2|Reported Event|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51438|NCT02079844|E1|Reported Event|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
51439|NCT02079805|B3|Baseline|Total|Total of all reporting groups
51440|NCT02079805|B2|Baseline|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51441|NCT02079805|B1|Baseline|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51442|NCT02079805|P2|Participant Flow|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51443|NCT02079805|P1|Participant Flow|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51444|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51445|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51446|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51447|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51448|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51449|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51450|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51451|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51452|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51453|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51454|NCT02079805|O2|Outcome|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
52342|NCT02073448|B4|Baseline|Total|Total of all reporting groups
51455|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51545|NCT02077374|B3|Baseline|Total|Total of all reporting groups
51457|NCT02079805|O1|Outcome|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51458|NCT02079805|E2|Reported Event|Azilsartan 20 mg|Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51459|NCT02079805|E1|Reported Event|Telmisartan 40 mg|Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
51460|NCT02079649|B5|Baseline|Total|Total of all reporting groups
51461|NCT02079649|B4|Baseline|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51462|NCT02079649|B3|Baseline|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51463|NCT02079649|B2|Baseline|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51464|NCT02079649|B1|Baseline|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51465|NCT02079649|P4|Participant Flow|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51466|NCT02079649|P3|Participant Flow|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51467|NCT02079649|P2|Participant Flow|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51468|NCT02079649|P1|Participant Flow|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51469|NCT02079649|O4|Outcome|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51470|NCT02079649|O3|Outcome|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51471|NCT02079649|O2|Outcome|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51472|NCT02079649|O1|Outcome|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51473|NCT02079649|O4|Outcome|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51474|NCT02079649|O3|Outcome|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51475|NCT02079649|O2|Outcome|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51476|NCT02079649|O1|Outcome|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
51477|NCT02079649|E5|Reported Event|Vehicle|Includes all subjects who were randomized to and treated with investigational product
51478|NCT02079649|E4|Reported Event|Maxidex|Includes all subjects who were randomized to and treated with investigational product
51479|NCT02079649|E3|Reported Event|AL-53817|Includes all subjects who were randomized to and treated with investigational product
51480|NCT02079649|E2|Reported Event|AL-78843|Includes all subjects who were randomized to and treated with investigational product
51481|NCT02079649|E1|Reported Event|Pre-Treatment|Includes all subjects who consented to participate in the study
51482|NCT02079532|B1|Baseline|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51483|NCT02079532|P1|Participant Flow|Rituximab Plus Methotrexate (MTX)|Participants received rituximab, 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51484|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51485|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51486|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51487|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51488|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
52343|NCT02073448|B3|Baseline|CD1579|"Benzoyl Peroxide 2.5% Gel
CD1579"
51489|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51490|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51491|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51492|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51493|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51494|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51495|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51496|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51497|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51498|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51499|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51500|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51501|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51502|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51503|NCT02079532|E1|Reported Event|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
51504|NCT02079519|B1|Baseline|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
51505|NCT02079519|P1|Participant Flow|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
51506|NCT02079519|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
51507|NCT02079519|E1|Reported Event|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
51508|NCT02079311|B3|Baseline|Total|Total of all reporting groups
51509|NCT02079311|B2|Baseline|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.
Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
52344|NCT02073448|B2|Baseline|CD0271|"Adapalene 01% Gel
CD0271"
51510|NCT02079311|B1|Baseline|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase
Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
51511|NCT02079311|P2|Participant Flow|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.
Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
51512|NCT02079311|P1|Participant Flow|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase
Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
51513|NCT02079311|O2|Outcome|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.
Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
51514|NCT02079311|O1|Outcome|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase
Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
51515|NCT02079311|E2|Reported Event|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.
Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
51516|NCT02079311|E1|Reported Event|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase
Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
51517|NCT02078492|B4|Baseline|Total|Total of all reporting groups
51518|NCT02078492|B3|Baseline|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.
30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
51519|NCT02078492|B2|Baseline|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.
15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
51520|NCT02078492|B1|Baseline|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.
10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
51521|NCT02078492|P3|Participant Flow|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.
30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
51522|NCT02078492|P2|Participant Flow|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.
15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
51523|NCT02078492|P1|Participant Flow|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.
10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
51524|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.
30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
51525|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.
15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
51526|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.
10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
51527|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.
30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
51528|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.
15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
51529|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.
10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
51530|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.
30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
51531|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.
15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
51532|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.
10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
51533|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.
30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
51534|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.
15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
51535|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.
10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
51536|NCT02078492|E3|Reported Event|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.
30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
51537|NCT02078492|E2|Reported Event|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.
15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
51538|NCT02078492|E1|Reported Event|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.
10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
51539|NCT02078193|B1|Baseline|Belatacept|All patients enrolled will be converted to Belatacept from prograf.
51540|NCT02078193|P1|Participant Flow|Belatacept|All patients enrolled will be converted to Belatacept from prograf.
51541|NCT02078193|O1|Outcome|Belatacept|"Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept
Belatacept: Patients will be converted from their MMF to Belatacept"
51542|NCT02078193|O1|Outcome|Belatacept|Participants who received Belatacept by IV infusion.
51601|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51543|NCT02078193|O1|Outcome|Belatacept|"Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept
Belatacept: Patients will be converted from their MMF to Belatacept"
51544|NCT02078193|E1|Reported Event|Belatacept|All patients enrolled will be converted to Belatacept from prograf.
51553|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg
IDN-6556: 25 mg BID for 28 days"
51554|NCT02077374|O2|Outcome|Placebo|"Placebo
Matching Placebo BID for 28 days"
51555|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg
IDN-6556: 25 mg BID for 28 days"
51556|NCT02077374|O2|Outcome|Placebo|"Placebo
Matching Placebo BID for 28 days"
51557|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg
IDN-6556: 25 mg BID for 28 days"
51558|NCT02077374|O2|Outcome|Placebo|"Placebo
Placebo: Placebo Twice daily for 28 Days"
51559|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg
IDN-6556: 25 mg Twice daily for 28 days"
51560|NCT02077374|O2|Outcome|Placebo|"Placebo
Matching Placebo BID for 28 days"
51561|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg
IDN-6556: 25 mg BID for 28 days"
51562|NCT02077374|E2|Reported Event|Placebo|"Placebo
Matching Placebo BID for 28 days"
51563|NCT02077374|E1|Reported Event|IDN-6556|"IDN-6556 capsules, 25 mg
IDN-6556: 25 mg BID for 28 days"
51564|NCT02076919|B13|Baseline|Total|Total of all reporting groups
51565|NCT02076919|B12|Baseline|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
51566|NCT02076919|B11|Baseline|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
51567|NCT02076919|B10|Baseline|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
51568|NCT02076919|B9|Baseline|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51569|NCT02076919|B8|Baseline|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51570|NCT02076919|B7|Baseline|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51571|NCT02076919|B6|Baseline|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51572|NCT02076919|B5|Baseline|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
51573|NCT02076919|B4|Baseline|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
51574|NCT02076919|B3|Baseline|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
51575|NCT02076919|B2|Baseline|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
51576|NCT02076919|B1|Baseline|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
51577|NCT02076919|P4|Participant Flow|Vehicle, Part 2|Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2
51578|NCT02076919|P3|Participant Flow|LHA510, Part 2|Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2
51579|NCT02076919|P2|Participant Flow|Vehicle, Part 1|Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1
51580|NCT02076919|P1|Participant Flow|LHA510, Part 1|Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1
51581|NCT02076919|O7|Outcome|Vehicle, Part 2|One drop instilled in the study eye once, twice, or three times daily for 7 days
51582|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
51583|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
51584|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51585|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51586|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51587|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51588|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
51589|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
51590|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
51591|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51592|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51593|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51594|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51595|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
51596|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
51597|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
51598|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51599|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51600|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51604|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
51605|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
51606|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
51607|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
51608|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
51609|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
51610|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
51611|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
51612|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
51613|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
51614|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
51615|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51616|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51617|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51618|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51619|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
51620|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
51621|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
51622|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
51623|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
51624|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
51625|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
51626|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
51627|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
51628|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
51629|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
51630|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
51631|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51632|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51633|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51634|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51635|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
51636|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
51637|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51638|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51639|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51640|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51641|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
51642|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
51643|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51644|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51645|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51646|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51647|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
51648|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
51649|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51650|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51651|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51652|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51653|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
51654|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
51655|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
51656|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51657|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51658|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51659|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51660|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
51661|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
51662|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
51663|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
51664|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
51665|NCT02076919|E12|Reported Event|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
51666|NCT02076919|E11|Reported Event|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
51667|NCT02076919|E10|Reported Event|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
51668|NCT02076919|E9|Reported Event|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51669|NCT02076919|E8|Reported Event|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
51670|NCT02076919|E7|Reported Event|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51671|NCT02076919|E6|Reported Event|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
51672|NCT02076919|E5|Reported Event|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
51673|NCT02076919|E4|Reported Event|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
51674|NCT02076919|E3|Reported Event|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
51675|NCT02076919|E2|Reported Event|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
51676|NCT02076919|E1|Reported Event|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
51677|NCT02076334|B5|Baseline|Total|Total of all reporting groups
51678|NCT02076334|B4|Baseline|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night
Far Infrared Fabric"
51679|NCT02076334|B3|Baseline|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night
Spandex"
51680|NCT02076334|B2|Baseline|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night
Far Infrared Fabric
Spandex"
51681|NCT02076334|B1|Baseline|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night
Far Infrared Fabric
Spandex"
51682|NCT02076334|P4|Participant Flow|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night
Far Infrared Fabric"
51683|NCT02076334|P3|Participant Flow|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night
Spandex"
51684|NCT02076334|P2|Participant Flow|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night
Far Infrared Fabric
Spandex"
51685|NCT02076334|P1|Participant Flow|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night
Far Infrared Fabric
Spandex"
51686|NCT02076334|O4|Outcome|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night
Far Infrared Fabric"
51687|NCT02076334|O3|Outcome|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night
Spandex"
51688|NCT02076334|O2|Outcome|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night
Far Infrared Fabric
Spandex"
51689|NCT02076334|O1|Outcome|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night
Far Infrared Fabric
Spandex"
51690|NCT02076334|O4|Outcome|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night
Far Infrared Fabric"
51691|NCT02076334|O3|Outcome|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night
Spandex"
51692|NCT02076334|O2|Outcome|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night
Far Infrared Fabric
Spandex"
51693|NCT02076334|O1|Outcome|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night
Far Infrared Fabric
Spandex"
51694|NCT02076334|E4|Reported Event|Test Garment + Test Garment|"Far Infrared Fabric during exercise + Far Infrared Fabric at night
Far Infrared Fabric"
51695|NCT02076334|E3|Reported Event|Normal Garment + Normal Garment|"Spandex during exercise + Spandex at night
Spandex"
51696|NCT02076334|E2|Reported Event|Normal Garment + Test Garment at Night|"Spandex during exercise + Far Infrared Fabric at night
Far Infrared Fabric
Spandex"
51697|NCT02076334|E1|Reported Event|Compression + Normal Garment|"Far Infrared Fabric during exercise + Spandex at night
Far Infrared Fabric
Spandex"
51698|NCT02076009|B3|Baseline|Total|Total of all reporting groups
51699|NCT02076009|B2|Baseline|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
51700|NCT02076009|B1|Baseline|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
51701|NCT02076009|P2|Participant Flow|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
51702|NCT02076009|P1|Participant Flow|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
51746|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
51703|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
51704|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
51720|NCT02076009|E1|Reported Event|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
51705|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
51706|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
51707|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
51708|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
51709|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
51710|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
51711|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
51712|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
51713|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
51714|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
51715|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
51716|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
51717|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
52345|NCT02073448|B1|Baseline|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G"
51718|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
51719|NCT02076009|E2|Reported Event|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
51722|NCT02075632|B2|Baseline|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used
51723|NCT02075632|B1|Baseline|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
51724|NCT02075632|P2|Participant Flow|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
51725|NCT02075632|P1|Participant Flow|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
51726|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
51727|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
51728|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
51729|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
51730|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
51731|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
51732|NCT02075632|E2|Reported Event|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
51733|NCT02075632|E1|Reported Event|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
51734|NCT02075515|B4|Baseline|Total|Total of all reporting groups
51735|NCT02075515|B3|Baseline|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51736|NCT02075515|B2|Baseline|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51737|NCT02075515|B1|Baseline|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51738|NCT02075515|P3|Participant Flow|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51739|NCT02075515|P2|Participant Flow|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51740|NCT02075515|P1|Participant Flow|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
51741|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51742|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51743|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51744|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51745|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51843|NCT02075125|E2|Reported Event|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
51747|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51748|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51749|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51750|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51751|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51752|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51753|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51754|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51755|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
51756|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51757|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51758|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51759|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51760|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51761|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
51762|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51763|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51764|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
51765|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51766|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51767|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51768|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51769|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51770|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51771|NCT02075515|E3|Reported Event|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
51772|NCT02075515|E2|Reported Event|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
52346|NCT02073448|P3|Participant Flow|CD1579|"Benzoyl Peroxide 2.5% Gel
CD1579"
51773|NCT02075515|E1|Reported Event|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
51774|NCT02075463|B1|Baseline|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51775|NCT02075463|P1|Participant Flow|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51776|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51777|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51778|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51779|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51780|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51781|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51782|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51783|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51784|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51785|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51786|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51787|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51788|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51789|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51790|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51791|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51792|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51793|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51844|NCT02075125|E1|Reported Event|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
51845|NCT02075073|B4|Baseline|Total|Total of all reporting groups
51794|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51795|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51796|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 mg QD for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve Hgb levels within the range of 10.0-11.5 g/dL; however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51797|NCT02075463|O1|Outcome|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51798|NCT02075463|E1|Reported Event|GSK1278863 12 mg QD|Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
51799|NCT02075411|B5|Baseline|Total|Total of all reporting groups
51800|NCT02075411|B4|Baseline|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51801|NCT02075411|B3|Baseline|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51802|NCT02075411|B2|Baseline|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Females Single shot peripheral nerve block"
51803|NCT02075411|B1|Baseline|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Males Single shot peripheral nerve block"
51804|NCT02075411|P4|Participant Flow|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51805|NCT02075411|P3|Participant Flow|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51806|NCT02075411|P2|Participant Flow|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Females Single shot peripheral nerve block"
51807|NCT02075411|P1|Participant Flow|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Males Single shot peripheral nerve block"
51808|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51809|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51810|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Females Single shot peripheral nerve block"
51811|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Males Single shot peripheral nerve block"
51812|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51846|NCT02075073|B3|Baseline|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®"
51813|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51814|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Females Single shot peripheral nerve block"
51815|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Males Single shot peripheral nerve block"
51854|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3"
51816|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51817|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51818|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Females Single shot peripheral nerve block"
51819|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Males Single shot peripheral nerve block"
51820|NCT02075411|E4|Reported Event|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51821|NCT02075411|E3|Reported Event|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
51822|NCT02075411|E2|Reported Event|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Females Single shot peripheral nerve block"
51823|NCT02075411|E1|Reported Event|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Males Single shot peripheral nerve block"
51824|NCT02075125|B3|Baseline|Total|Total of all reporting groups
51825|NCT02075125|B2|Baseline|Ticagrelor|Patients administer Ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
51826|NCT02075125|B1|Baseline|Prasugrel|Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
51827|NCT02075125|P2|Participant Flow|Ticagrelor|Patient administer Ticagrelor 180 mg as loading dose followed by 90 mg twice a day as maintenance dose.
51828|NCT02075125|P1|Participant Flow|Prasugrel|Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
51829|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
51830|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
51831|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
51832|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
51833|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
51834|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
51835|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
51836|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
51837|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
51838|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
51839|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
51840|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
51841|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
51842|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
51847|NCT02075073|B2|Baseline|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®"
51848|NCT02075073|B1|Baseline|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3"
51849|NCT02075073|P3|Participant Flow|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®"
51850|NCT02075073|P2|Participant Flow|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®"
51851|NCT02075073|P1|Participant Flow|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3"
51852|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®"
51853|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®"
83994|NCT01877720|E1|Reported Event|NIV-NAVA|non-invasive NAVA
51855|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®"
51856|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®"
51857|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3"
51858|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®"
51859|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®"
51860|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3"
51861|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®"
51862|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®"
51863|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3"
51864|NCT02075073|E3|Reported Event|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
US sourced Herceptin®"
51865|NCT02075073|E2|Reported Event|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
EU sourced Herceptin®"
51866|NCT02075073|E1|Reported Event|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
SB3"
51867|NCT02075008|B1|Baseline|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
51868|NCT02075008|P1|Participant Flow|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
51869|NCT02075008|O1|Outcome|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
51870|NCT02075008|E1|Reported Event|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
51871|NCT02074995|B1|Baseline|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51872|NCT02074995|P3|Participant Flow|BVS857 Group 1B/1C, 2, 3, 4 Double Blind|
51873|NCT02074995|P2|Participant Flow|Placebo Group 1B/1C, 2, 3, 4|
51874|NCT02074995|P1|Participant Flow|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51875|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51876|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51877|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51878|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51879|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51880|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51881|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51882|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51883|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51884|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51885|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51886|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51887|NCT02074995|E1|Reported Event|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
51888|NCT02074982|B3|Baseline|Total|Total of all reporting groups
51889|NCT02074982|B2|Baseline|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
52351|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G"
51890|NCT02074982|B1|Baseline|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
51891|NCT02074982|P2|Participant Flow|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
51892|NCT02074982|P1|Participant Flow|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
51893|NCT02074982|O2|Outcome|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
52122|NCT02074384|B2|Baseline|Self Monitoring Blood Glucose|"Participants will self test for two weeks.
Self Monitoring Blood Glucose: Participants will use their own SMBG device."
51894|NCT02074982|O1|Outcome|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
51895|NCT02074982|O2|Outcome|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
51896|NCT02074982|O1|Outcome|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
51897|NCT02074982|O2|Outcome|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
51898|NCT02074982|O1|Outcome|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
51899|NCT02074982|E2|Reported Event|Ustekinumab|patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
51900|NCT02074982|E1|Reported Event|AIN457 300 mg|patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
51901|NCT02074709|B3|Baseline|Total|Total of all reporting groups
51902|NCT02074709|B2|Baseline|Wound Infiltration|Wound infiltration with liposomal bupivacaine
51903|NCT02074709|B1|Baseline|TAP Block|TAP block with plain bupivacaine
51904|NCT02074709|P2|Participant Flow|Wound Infiltration|"Wound infiltration with liposomal bupivacaine
Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV
First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
51905|NCT02074709|P1|Participant Flow|TAP Block|"TAP block with plain bupivacaine
Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .
First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn"
51906|NCT02074709|O2|Outcome|Wound Infiltration|"Wound infiltration with liposomal bupivacaine
Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV"
51907|NCT02074709|O1|Outcome|TAP Block|"TAP block with plain bupivacaine
Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV ."
51908|NCT02074709|E2|Reported Event|Wound Infiltration|"Wound infiltration with liposomal bupivacaine
Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV
First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
51909|NCT02074709|E1|Reported Event|TAP Block|"TAP block with plain bupivacaine
Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .
First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn"
51910|NCT02074553|B3|Baseline|Total|Total of all reporting groups
51911|NCT02074553|B2|Baseline|Part 2 (Fed): Study Population|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 2 of the study.
51912|NCT02074553|B1|Baseline|Part 1 (Fasted): Study Population|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 1 of the study.
51913|NCT02074553|P8|Participant Flow|Part 2 (Fed): Treatment D Then C Then B Then A|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
51926|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
51914|NCT02074553|P7|Participant Flow|Part 2 (Fed): Treatment C Then A Then D Then B|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
51951|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
83995|NCT01877668|B6|Baseline|Total|Total of all reporting groups
51915|NCT02074553|P6|Participant Flow|Part 2 (Fed): Treatment B Then D Then A Then C|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
51916|NCT02074553|P5|Participant Flow|Part 2 (Fed): Treatment A Then B Then C Then D|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment A (formulation containing 50% SLS) on Day 1 of the first intervention period; then Treatment B (formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
51917|NCT02074553|P4|Participant Flow|Part 1 (Fasted): Treatment D Then C Then B Then A|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
51918|NCT02074553|P3|Participant Flow|Part 1 (Fasted): Treatment C Then A Then D Then B|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
51919|NCT02074553|P2|Participant Flow|Part 1 (Fasted): Treatment B Then D Then A Then C|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
51920|NCT02074553|P1|Participant Flow|Part 1 (Fasted): Treatment A Then B Then C Then D|Participants following an overnight fast of at least 10 hours received 600 milligram (mg) of alectinib (RO5424802) as a capsule formulation (four 150 mg capsules) orally in Part 1 of the study according to following treatment sequences. Treatment A (Reference Treatment: formulation containing 50 percent [%]sodium lauryl sulfate [SLS]) on Day 1 of the first intervention period; then Treatment B (Test Treatment: formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (Test Treatment: formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (Test Treatment: formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
51921|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
51922|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
51923|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
51924|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
51925|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52117|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
51927|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
51928|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52119|NCT02074514|E1|Reported Event|SOF + RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
52120|NCT02074384|B4|Baseline|Total|Total of all reporting groups
51929|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
51930|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
51931|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
51932|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
51933|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
51934|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
51935|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
51936|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
51937|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
51938|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
51939|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
51940|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
51941|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
51942|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
51943|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
51944|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
51945|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
51946|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
51947|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
51948|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
51949|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
51950|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52121|NCT02074384|B3|Baseline|Clinicians|Clinicians completing the study visits.
52284|NCT02074059|E2|Reported Event|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
51952|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
51953|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
51954|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
51955|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
51956|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
51957|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
51958|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
51959|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
51960|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
51961|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
51962|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
51963|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
51964|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
51965|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
51966|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
51967|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
51968|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
51969|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
51970|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
51971|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52063|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52352|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel
CD1579"
51972|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52285|NCT02074059|E1|Reported Event|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
51973|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
51974|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
51975|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
51976|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
51977|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
51978|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
51979|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
51980|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
51981|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
51982|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
51983|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
51984|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
51985|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
51986|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
51987|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
51988|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
51989|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
51990|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
51991|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
51992|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
51993|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
51994|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52353|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel
CD0271"
51995|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
51996|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
51997|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
51998|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
51999|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52000|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52001|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
52002|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52003|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52004|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52005|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52006|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52007|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52008|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52009|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
52010|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52011|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52012|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52013|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52014|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52015|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52016|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52017|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
97398|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
52018|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52019|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52020|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52021|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52022|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52023|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52024|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52025|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
52026|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52027|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52028|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52029|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52030|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52031|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52032|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52033|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
52034|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52035|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52036|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52037|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52038|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52039|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52040|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
97399|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
52041|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
52042|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52043|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52044|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52045|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52046|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52047|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52048|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52049|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
52050|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52051|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52052|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52053|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52054|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52055|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52056|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52057|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
52058|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52059|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52060|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52061|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52062|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52115|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
52064|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52286|NCT02073747|B3|Baseline|Total|Total of all reporting groups
52065|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
52066|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52067|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52068|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52069|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52070|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52071|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52072|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52073|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
52074|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52075|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52076|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52077|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52078|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52079|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52080|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52081|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
52082|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52083|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52084|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52085|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52116|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
52086|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52087|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52088|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52089|NCT02074553|E8|Reported Event|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
52090|NCT02074553|E7|Reported Event|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
52091|NCT02074553|E6|Reported Event|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
52092|NCT02074553|E5|Reported Event|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
52093|NCT02074553|E4|Reported Event|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
52094|NCT02074553|E3|Reported Event|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
52095|NCT02074553|E2|Reported Event|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
52096|NCT02074553|E1|Reported Event|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
52097|NCT02074514|B5|Baseline|Total|Total of all reporting groups
52098|NCT02074514|B4|Baseline|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
52099|NCT02074514|B3|Baseline|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
52100|NCT02074514|B2|Baseline|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
52101|NCT02074514|B1|Baseline|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
52102|NCT02074514|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks.
52103|NCT02074514|P1|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 16 weeks.
52104|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
52105|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
52106|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
52107|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
52108|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
52109|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
52110|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
52111|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
52112|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
52113|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
52114|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
52347|NCT02073448|P2|Participant Flow|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G"
52118|NCT02074514|E2|Reported Event|SOF + RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
52287|NCT02073747|B2|Baseline|Normal Saline|Control group
52123|NCT02074384|B1|Baseline|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.
Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
52124|NCT02074384|P3|Participant Flow|Clinicians|Clinicians completing study AGP visits.
52125|NCT02074384|P2|Participant Flow|Self Monitoring Blood Glucose|"Participants will self test for two weeks.
Self Monitoring Blood Glucose: Participants will use their own SMBG device."
52126|NCT02074384|P1|Participant Flow|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.
Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
52127|NCT02074384|O3|Outcome|Clinicians|Clinicians completing the study visits.
52128|NCT02074384|O2|Outcome|Self Monitoring Blood Glucose|"Participants will self test for two weeks.
Self Monitoring Blood Glucose: Participants will use their own SMBG device."
52129|NCT02074384|O1|Outcome|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.
Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
52130|NCT02074384|E3|Reported Event|Clinicians|"Clinicians completing study visits.
Clinician: Survey of clinicians after study visits"
52131|NCT02074384|E2|Reported Event|Self Monitoring Blood Glucose|"Participants will self test for two weeks.
Self Monitoring Blood Glucose: Participants will use their own SMBG device."
52132|NCT02074384|E1|Reported Event|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.
Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
52133|NCT02074358|B1|Baseline|All Treated Participants|Treated population included all participants who received at least one dose of study medication. Participants received 10 mg apixaban BID on Days 1-3 and on Day 4 received a single dose of 10 mg apixaban followed 3 hours later by an IV infusion of 50 IU/kg prothrombin complex concentrate (PCC) (which was either Cofact or Beriplex P/N) or the participant received an IV infusion of placebo (saline solution). Participants were randomized on Day 1 to one of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB and CBA). There were 3 treatment periods with a total of 3 participants in each of 3 sequences (ABC, ACB, CAB) and 2 participants in each of 3 other sequences (CBA, BAC, BCA) for a total of 15 participants who participated in this open label, randomized, crossover study.
52134|NCT02074358|P6|Participant Flow|Treatment CBA|"Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.
Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.
Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes."
52135|NCT02074358|P5|Participant Flow|Treatment CAB|"Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.
Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.
Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
52136|NCT02074358|P4|Participant Flow|Treatment BCA|"Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.
Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes."
52137|NCT02074358|P3|Participant Flow|Treatment BAC|"Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.
Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
52138|NCT02074358|P2|Participant Flow|Treatment ACB|"Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.
Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
52161|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52162|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52139|NCT02074358|P1|Participant Flow|Treatment ABC|"Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID) on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours (hrs) later by Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) intravenous infusion (IV) for 30 minutes.
Treatment B: Apixaban + Cofact [4-Factor prothrombin complex concentrate (PCC)]: Apixaban 10 mg oral Tablet BID on Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 min."
52140|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52141|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52142|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52143|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52144|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52145|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52146|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52147|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52148|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52149|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52150|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52151|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52152|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52153|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52154|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52155|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52156|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52157|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52158|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52159|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52160|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52348|NCT02073448|P1|Participant Flow|CD0271|"Adapalene 01% Gel
CD0271"
52163|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52164|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52288|NCT02073747|B1|Baseline|Albuterol|Study group
52165|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52166|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52167|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52168|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52169|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52170|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52171|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52172|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52173|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52174|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52175|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52176|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52177|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52178|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52179|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52180|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52181|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52182|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52183|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52184|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52185|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52277|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
52349|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel
CD1579"
52186|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52187|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52188|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52189|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52190|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52191|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52192|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52193|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52194|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52195|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52196|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52197|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52198|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52199|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52200|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52201|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52202|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52203|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52204|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52205|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52206|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52207|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52208|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52278|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
52350|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel
CD0271"
52209|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52210|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52211|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52212|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52213|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52214|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52215|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52216|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52217|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52218|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52219|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52220|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52221|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52222|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52223|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52224|NCT02074358|E3|Reported Event|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
52225|NCT02074358|E2|Reported Event|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
52226|NCT02074358|E1|Reported Event|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
52227|NCT02074345|B1|Baseline|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
52228|NCT02074345|P1|Participant Flow|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
52229|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
52230|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
52231|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
52279|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
52280|NCT02074059|E6|Reported Event|nCPAP Alone|nCPAP therapy alone
52232|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
52233|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
52234|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
52235|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
52236|NCT02074345|E1|Reported Event|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
52237|NCT02074059|B7|Baseline|Total|Total of all reporting groups
52238|NCT02074059|B6|Baseline|nCPAP Alone|nCPAP therapy alone
52239|NCT02074059|B5|Baseline|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of lucinactant for Inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52240|NCT02074059|B4|Baseline|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of lucinactant for Inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52241|NCT02074059|B3|Baseline|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of lucinactant for inhalation with nCPAP
52242|NCT02074059|B2|Baseline|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of lucinactant for inhalation with nCPAP
52243|NCT02074059|B1|Baseline|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of lucinactant for inhalation with nCPAP
52244|NCT02074059|P6|Participant Flow|nCPAP Alone|"nCPAP therapy alone
nCPAP alone: nCPAP therapy"
52245|NCT02074059|P5|Participant Flow|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52246|NCT02074059|P4|Participant Flow|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52247|NCT02074059|P3|Participant Flow|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
52248|NCT02074059|P2|Participant Flow|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
52249|NCT02074059|P1|Participant Flow|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
52250|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
52251|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52252|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52253|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
52254|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
52255|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
52256|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
52257|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52258|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52259|NCT02074059|O3|Outcome|Aerosolized Lucinactant (High Dose)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
52260|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
52261|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
52262|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
52263|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52264|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52265|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
52266|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
52267|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
52268|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
52269|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52270|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52271|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
52272|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
52273|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
52274|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
52275|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52276|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52328|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%
CD1579 5%"
52281|NCT02074059|E5|Reported Event|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52282|NCT02074059|E4|Reported Event|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
52283|NCT02074059|E3|Reported Event|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
52364|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel
CD1579"
52289|NCT02073747|P2|Participant Flow|Albuterol Trial Group|"Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol
Albuterol: One hour inhaled ten milligrams of albuterol"
52290|NCT02073747|P1|Participant Flow|Normal Saline Control Group|"Control group will be administered a one hour normal saline inhaled treatment.
Normal Saline: One hour inhaled normal saline"
52291|NCT02073747|O2|Outcome|Albuterol Trial Group|"Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol
Albuterol: One hour inhaled ten milligrams of albuterol"
52292|NCT02073747|O1|Outcome|Normal Saline Control Group|"Control group will be administered a one hour normal saline inhaled treatment.
Normal Saline: One hour inhaled normal saline"
52293|NCT02073747|E2|Reported Event|Normal Saline|Control group
52294|NCT02073747|E1|Reported Event|Albuterol|Study group; 10 mg of nebulizer albuterol
52295|NCT02073656|B1|Baseline|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
52296|NCT02073656|P1|Participant Flow|LDV/SOF 12 Weeks|"Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 24 weeks."
52297|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
52298|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
52299|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
52300|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
52301|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
52302|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
52303|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
52304|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
52305|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
52306|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
52307|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
52308|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
52309|NCT02073656|E2|Reported Event|LDV/SOF+RBV 24 Weeks (Retreatment)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
52310|NCT02073656|E1|Reported Event|LDV/SOF 12 Weeks (Primary Study)|LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
52311|NCT02073461|B4|Baseline|Total|Total of all reporting groups
52312|NCT02073461|B3|Baseline|Vehicle|"Vehicle
Vehicle"
52313|NCT02073461|B2|Baseline|CD1579 5%|"Benzoyl Peroxide 5%
CD1579 5%"
52314|NCT02073461|B1|Baseline|CD1579 2.5%|"Benzoyl Peroxide 2.5%
CD1579 2.5%"
52315|NCT02073461|P3|Participant Flow|Vehicle|"Vehicle
Vehicle"
52316|NCT02073461|P2|Participant Flow|CD1579 5%|"Benzoyl Peroxide 5%
CD1579 5%"
52317|NCT02073461|P1|Participant Flow|CD1579 2.5%|"Benzoyl Peroxide 2.5%
CD1579 2.5%"
52318|NCT02073461|O3|Outcome|Vehicle|"Vehicle
Vehicle"
52319|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%
CD1579 5%"
52320|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%
CD1579 2.5%"
52321|NCT02073461|O3|Outcome|Vehicle|"Vehicle
Vehicle"
52322|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%
CD1579 5%"
52323|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%
CD1579 2.5%"
52324|NCT02073461|O3|Outcome|Vehicle|"Vehicle
Vehicle"
52325|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%
CD1579 5%"
52326|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%
CD1579 2.5%"
52327|NCT02073461|O3|Outcome|Vehicle|"Vehicle
Vehicle"
52354|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G"
52355|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel
CD1579"
52356|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel
CD0271"
52357|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G"
52358|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel
CD1579"
52359|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel
CD0271"
52360|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G"
52361|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel
CD1579"
52362|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel
CD0271"
52363|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G"
52365|NCT02073448|O2|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G"
52366|NCT02073448|O1|Outcome|CD0271|"Adapalene 01% Gel
CD0271"
52367|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel
CD1579"
52368|NCT02073448|O2|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G"
52369|NCT02073448|O1|Outcome|CD0271|"Adapalene 01% Gel
CD0271"
52370|NCT02073448|E3|Reported Event|CD1579|"Benzoyl Peroxide 2.5% Gel
CD1579"
52371|NCT02073448|E2|Reported Event|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G"
52372|NCT02073448|E1|Reported Event|CD0271|"Adapalene 01% Gel
CD0271"
52373|NCT02072980|B1|Baseline|Overall|Delefilcon A contact lenses worn during Period 1 and Period 2
52374|NCT02072980|P2|Participant Flow|15min/16hr|Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, follwed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2.
52375|NCT02072980|P1|Participant Flow|16hr/15min|Delefilcon A contact lenses worn bilaterally for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2.
52376|NCT02072980|O1|Outcome|15 Minutes|Delefilcon A contact lenses worn for 15 minutes during Period 1 or 2
52377|NCT02072980|O2|Outcome|Unworn|Unworn delefilcon A contact lenses removed from the commercial packaging and soaked overnight in phosphate buffered saline
52378|NCT02072980|O1|Outcome|16 Hours|Delefilcon A contact lenses worn for 16 hours in Period 1 or 2
52379|NCT02072980|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn during Period 1 and Period 2
52380|NCT02072421|B1|Baseline|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
52381|NCT02072421|P1|Participant Flow|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
52382|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
52383|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
52384|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
52385|NCT02072421|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
52386|NCT02072421|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
52387|NCT02072421|E1|Reported Event|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
52388|NCT02072200|B1|Baseline|Modified Release Prednisone|"Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
52389|NCT02072200|P1|Participant Flow|Modified Release Prednisone|"Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
52390|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
52391|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
52392|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
52393|NCT02072200|E1|Reported Event|Modified Release Prednisone|"Single arm / Lodotra
Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
52394|NCT02072096|B3|Baseline|Total|Total of all reporting groups
52395|NCT02072096|B2|Baseline|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine dose is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
52396|NCT02072096|B1|Baseline|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
52397|NCT02072096|P2|Participant Flow|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
52463|NCT02071823|E1|Reported Event|Fasted Conditions|Fasted conditions period
52464|NCT02071810|B6|Baseline|Total|Total of all reporting groups
52398|NCT02072096|P1|Participant Flow|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
52399|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
52476|NCT02071810|O4|Outcome|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg
BIA 9-1067"
52400|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
52401|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
52402|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
52403|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
52404|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
52405|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
52406|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
52407|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
52408|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
52409|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
52410|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
52411|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
52412|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
52465|NCT02071810|B5|Baseline|Placebo|"Placebo, PLC
Placebo"
52466|NCT02071810|B4|Baseline|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg
BIA 9-1067"
52413|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
52414|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
52415|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
52416|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
52417|NCT02072096|E2|Reported Event|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
52418|NCT02072096|E1|Reported Event|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
52419|NCT02071849|B1|Baseline|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52420|NCT02071849|P1|Participant Flow|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52421|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52422|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52423|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52424|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52425|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52426|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52427|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52428|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52429|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52430|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52431|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52432|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52433|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52467|NCT02071810|B3|Baseline|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg
BIA 9-1067"
52434|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52435|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52436|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52437|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52438|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52439|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52440|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52441|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52442|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52443|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52444|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52445|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52446|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52447|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52448|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52449|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52450|NCT02071849|E1|Reported Event|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
52451|NCT02071823|B3|Baseline|Total|Total of all reporting groups
52452|NCT02071823|B2|Baseline|Group B Fasted/Fed|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fasted Washout Period (7days) Period 2: Fed
BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
52453|NCT02071823|B1|Baseline|Group A Fed/Fasted|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fed Washout Period (7days) Period 2: Fasted
BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
52454|NCT02071823|P2|Participant Flow|Group B Fasted/Fed|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fasted Washout Period (7days) Period 2: Fed
BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
52455|NCT02071823|P1|Participant Flow|Group A Fed/Fasted|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fed Washout Period (7days) Period 2: Fasted
BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
52456|NCT02071823|O2|Outcome|Fed Condition|Fed condition period
52457|NCT02071823|O1|Outcome|Fasted Conditions|Fasted conditions period
52458|NCT02071823|O2|Outcome|Fasted Condition|Fasted condition period
52459|NCT02071823|O1|Outcome|Fed Conditions|Fed conditions period
52460|NCT02071823|O2|Outcome|Fed Condition|Fed condition period
52461|NCT02071823|O1|Outcome|Fasted Conditions|Fasted conditions period
52462|NCT02071823|E2|Reported Event|Fed Condition|Fed condition period
52468|NCT02071810|B2|Baseline|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg
BIA 9-1067"
52469|NCT02071810|B1|Baseline|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg
BIA 9-1067"
52470|NCT02071810|P5|Participant Flow|Placebo|"Placebo, PLC
Placebo"
52471|NCT02071810|P4|Participant Flow|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg
BIA 9-1067"
52472|NCT02071810|P3|Participant Flow|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg
BIA 9-1067"
52473|NCT02071810|P2|Participant Flow|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg
BIA 9-1067"
52474|NCT02071810|P1|Participant Flow|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg
BIA 9-1067"
52475|NCT02071810|O5|Outcome|Placebo|"Placebo, PLC
Placebo"
87582|NCT01854645|B5|Baseline|Placebo|Placebo MDI
52477|NCT02071810|O3|Outcome|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg
BIA 9-1067"
52478|NCT02071810|O2|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg
BIA 9-1067"
52479|NCT02071810|O1|Outcome|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg
BIA 9-1067"
52480|NCT02071810|E5|Reported Event|Placebo|"Placebo, PLC
Placebo"
52481|NCT02071810|E4|Reported Event|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg
BIA 9-1067"
52482|NCT02071810|E3|Reported Event|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg
BIA 9-1067"
52483|NCT02071810|E2|Reported Event|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg
BIA 9-1067"
52484|NCT02071810|E1|Reported Event|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg
BIA 9-1067"
52485|NCT02071771|B1|Baseline|Overall|Nelfilcon A and Etafilcon A toric contact lenses worn during Period 1 and Period 2, as randomized, in a crossover assignment.
52486|NCT02071771|P2|Participant Flow|1DAM A, Then DACP T|Etafilcon A toric contact lenses worn first, with Nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
52487|NCT02071771|P1|Participant Flow|DACP T, Then 1DAM A|Nelfilcon A toric contact lenses worn first, with Etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
52488|NCT02071771|O2|Outcome|1DAM A|Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
52489|NCT02071771|O1|Outcome|DACP T|Nelfilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
52490|NCT02071771|O2|Outcome|1DAM A|Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
52491|NCT02071771|O1|Outcome|DACP T|Nelfilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
52492|NCT02071771|E2|Reported Event|1DAM A|Etafilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days.
52493|NCT02071771|E1|Reported Event|DACP T|Nelfilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days.
52494|NCT02071108|B1|Baseline|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52495|NCT02071108|P1|Participant Flow|Lithoplasty Treatment|All subjects were treated with the Shockwave Medical Peripheral Lithoplasty System
52496|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52497|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52498|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52499|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52500|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52501|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52502|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52503|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52504|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52505|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52506|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52507|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52508|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52509|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52510|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52511|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52512|NCT02071108|E1|Reported Event|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
52513|NCT02071082|B3|Baseline|Total|Total of all reporting groups
52514|NCT02071082|B2|Baseline|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52515|NCT02071082|B1|Baseline|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52516|NCT02071082|P2|Participant Flow|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52517|NCT02071082|P1|Participant Flow|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks.
52518|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52519|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52520|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52521|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52522|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52523|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52609|NCT02070380|B2|Baseline|Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
52524|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52525|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52526|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52527|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52528|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52529|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52530|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52531|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52532|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52533|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52534|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52535|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52536|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52537|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52538|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52539|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52540|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52541|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
52542|NCT02071082|E2|Reported Event|HIV-Suppressed|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV-suppressed)
52543|NCT02071082|E1|Reported Event|HIV/HBV Treatment-Naive|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV treatment-naive and HBV treatment-naive)
52544|NCT02070965|B4|Baseline|Total|Total of all reporting groups
52545|NCT02070965|B3|Baseline|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days
DFD01 Spray"
52546|NCT02070965|B2|Baseline|Comp01 Lotion|"Comp01 Lotion, bid, 14 days
Comp01 Lotion"
52547|NCT02070965|B1|Baseline|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days
DFD01 Spray"
52548|NCT02070965|P3|Participant Flow|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days
DFD01 Spray"
52549|NCT02070965|P2|Participant Flow|Comp01 Lotion|"Comp01 Lotion, bid, 14 days
Comp01 Lotion"
52550|NCT02070965|P1|Participant Flow|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days
DFD01 Spray"
52551|NCT02070965|O3|Outcome|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days
DFD01 Spray"
52552|NCT02070965|O2|Outcome|Comp01 Lotion|"Comp01 Lotion, bid, 14 days
Comp01 Lotion"
52553|NCT02070965|O1|Outcome|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days
DFD01 Spray"
52554|NCT02070965|E3|Reported Event|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days
DFD01 Spray"
52555|NCT02070965|E2|Reported Event|Comp01 Lotion|"Comp01 Lotion, bid, 14 days
Comp01 Lotion"
52556|NCT02070965|E1|Reported Event|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days
DFD01 Spray"
52557|NCT02070692|B3|Baseline|Total|Total of all reporting groups
52558|NCT02070692|B2|Baseline|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
52559|NCT02070692|B1|Baseline|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.
Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
52654|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52560|NCT02070692|P2|Participant Flow|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
52561|NCT02070692|P1|Participant Flow|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.
Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
52562|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
53698|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
52563|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.
Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
52564|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
52565|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.
Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
52566|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
52567|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.
Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
52568|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
52569|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.
Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
52570|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
52571|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.
Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
52572|NCT02070692|E2|Reported Event|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
52573|NCT02070692|E1|Reported Event|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.
Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
52574|NCT02070640|B3|Baseline|Total|Total of all reporting groups
52575|NCT02070640|B2|Baseline|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
52576|NCT02070640|B1|Baseline|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
52577|NCT02070640|P2|Participant Flow|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
52578|NCT02070640|P1|Participant Flow|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
52579|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
52580|NCT02070640|O1|Outcome|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
53440|NCT02062580|B1|Baseline|Delayed BCG|"BCG delayed to 8 weeks of age
BCG"
52581|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
52610|NCT02070380|B1|Baseline|MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.1 mmol/kg first
53699|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
52582|NCT02070640|O1|Outcome|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
52583|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
52584|NCT02070640|O1|Outcome|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
52585|NCT02070640|E2|Reported Event|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
52586|NCT02070640|E1|Reported Event|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
52587|NCT02070588|B4|Baseline|Total|Total of all reporting groups
52588|NCT02070588|B3|Baseline|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52589|NCT02070588|B2|Baseline|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52590|NCT02070588|B1|Baseline|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52591|NCT02070588|P3|Participant Flow|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52592|NCT02070588|P2|Participant Flow|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52593|NCT02070588|P1|Participant Flow|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52594|NCT02070588|O3|Outcome|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52595|NCT02070588|O2|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52596|NCT02070588|O1|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52597|NCT02070588|O3|Outcome|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52598|NCT02070588|O2|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52599|NCT02070588|O1|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52600|NCT02070588|O3|Outcome|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52601|NCT02070588|O2|Outcome|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52602|NCT02070588|O1|Outcome|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52603|NCT02070588|E3|Reported Event|Volunteers|"MRI Diagnostic of Volunteer Controls for Device Calibration
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52604|NCT02070588|E2|Reported Event|Experimental: Diagnostic Non mTBI|"MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52655|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52605|NCT02070588|E1|Reported Event|Experimental: Diagnostic mTBI|"MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI: MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects"
52606|NCT02070380|B5|Baseline|Total|Total of all reporting groups
52607|NCT02070380|B4|Baseline|Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
52608|NCT02070380|B3|Baseline|MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.05 mmol/kg first
52611|NCT02070380|P4|Participant Flow|Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
52612|NCT02070380|P3|Participant Flow|MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.05 mmol/kg first
52613|NCT02070380|P2|Participant Flow|Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
52614|NCT02070380|P1|Participant Flow|MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.1 mmol/kg first
52615|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52616|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52617|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52618|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52619|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52620|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52621|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52622|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52623|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52624|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52625|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52626|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52627|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52628|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52629|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52630|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52631|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52632|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52633|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52634|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52635|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52636|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52637|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52638|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52639|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52640|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52641|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52642|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52643|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52644|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52645|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52646|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52647|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52648|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52649|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52650|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52651|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52652|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52653|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52656|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
52657|NCT02070380|E4|Reported Event|Study Arm 2 / Dotarem 0.1 mmol/kg|"Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg.
54 (Dotarem as 1st injection) + 51 (Dotarem as 2nd injection) =105"
52658|NCT02070380|E3|Reported Event|Study Arm 2/ MultiHance 0.05 mmol/kg|"Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with MultiHance 0.05 mmol/kg.
53 (MH as 1st injection) + 51 (MH as 2nd injection) = 104"
52659|NCT02070380|E2|Reported Event|Study Arm 1 / Dotarem 0.1 mmol/kg|"Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg.
39 (Dotarem as 1st injection) + 31 (Dotarem as 2nd injection) =70"
53700|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
52660|NCT02070380|E1|Reported Event|Study Arm 1 / MultiHance 0.1 mmol/kg|"Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with MultiHance 0.1 mmol/kg.
31 (MH as 1st injection) + 34 (MH as 2nd injection) = 65"
52661|NCT02070237|B3|Baseline|Total|Total of all reporting groups
52662|NCT02070237|B2|Baseline|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
52663|NCT02070237|B1|Baseline|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
52664|NCT02070237|P2|Participant Flow|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
52665|NCT02070237|P1|Participant Flow|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
52666|NCT02070237|O2|Outcome|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
52667|NCT02070237|O1|Outcome|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
52668|NCT02070237|O2|Outcome|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
52669|NCT02070237|O1|Outcome|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
52670|NCT02070237|E2|Reported Event|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
52671|NCT02070237|E1|Reported Event|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
52672|NCT02069093|B1|Baseline|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
52693|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
53441|NCT02062580|P2|Participant Flow|Early BCG|"BCG at birth; standard of care
BCG"
52673|NCT02069093|P1|Participant Flow|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
52674|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
52675|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
52676|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
52677|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
52678|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
52679|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
52680|NCT02069093|E1|Reported Event|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
52681|NCT02068443|B4|Baseline|Total|Total of all reporting groups
52682|NCT02068443|B3|Baseline|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52683|NCT02068443|B2|Baseline|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52684|NCT02068443|B1|Baseline|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
52685|NCT02068443|P3|Participant Flow|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52686|NCT02068443|P2|Participant Flow|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52687|NCT02068443|P1|Participant Flow|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
52688|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52689|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52690|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
52691|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52692|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52972|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52694|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52695|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52910|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52696|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
52697|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52698|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52699|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
52700|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52701|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52702|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
52703|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52704|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52705|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
52706|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52707|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52708|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
52709|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52710|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52711|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
52712|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52713|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52714|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
52715|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52746|NCT02067728|B1|Baseline|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52716|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52717|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
53701|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
52718|NCT02068443|E3|Reported Event|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
52719|NCT02068443|E2|Reported Event|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
52720|NCT02068443|E1|Reported Event|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
52721|NCT02068222|B1|Baseline|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet"
52722|NCT02068222|P1|Participant Flow|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet"
52723|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet"
52724|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet"
52725|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet"
52726|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet"
52727|NCT02068222|E1|Reported Event|ABT-450/r and ABT-530 Plus RBV|ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
52728|NCT02068157|B1|Baseline|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo image-guided I-PDT
Porfimer Sodium: Given IV"
52729|NCT02068157|P1|Participant Flow|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo image-guided I-PDT
Porfimer Sodium: Given IV"
52730|NCT02068157|O1|Outcome|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo image-guided I-PDT
Porfimer Sodium: Given IV"
52731|NCT02068157|O1|Outcome|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo image-guided I-PDT
Porfimer Sodium: Given IV"
52732|NCT02068157|E1|Reported Event|Treatment (Porfimer Sodium, Image-guided I-PDT)|"Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo image-guided I-PDT
Porfimer Sodium: Given IV"
52733|NCT02068027|B3|Baseline|Total|Total of all reporting groups
52734|NCT02068027|B2|Baseline|Placebo|"Placebo gel of identical appearance as active treatment
Placebo"
52735|NCT02068027|B1|Baseline|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%
Clonidine Gel 0.1%"
52736|NCT02068027|P2|Participant Flow|Placebo|"Placebo gel of identical appearance as active treatment
Placebo"
52737|NCT02068027|P1|Participant Flow|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%
Clonidine Gel 0.1%"
52738|NCT02068027|O2|Outcome|Placebo|"Placebo gel of identical appearance as active treatment
Placebo"
52739|NCT02068027|O1|Outcome|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%
Clonidine Gel 0.1%"
52740|NCT02068027|O2|Outcome|Placebo|"Placebo gel of identical appearance as active treatment
Placebo"
52741|NCT02068027|O1|Outcome|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%
Clonidine Gel 0.1%"
52742|NCT02068027|E2|Reported Event|Placebo|"Placebo gel of identical appearance as active treatment
Placebo"
52743|NCT02068027|E1|Reported Event|Clonidine Gel 0.1%|"Clonidine hydrochloride topical gel, 0.1%
Clonidine Gel 0.1%"
52744|NCT02067728|B3|Baseline|Total|Total of all reporting groups
52745|NCT02067728|B2|Baseline|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52908|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52747|NCT02067728|P2|Participant Flow|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
53702|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
52748|NCT02067728|P1|Participant Flow|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52749|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52750|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52751|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52752|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52753|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52754|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52755|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52756|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52757|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52758|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52759|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52760|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52761|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52762|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52763|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52764|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52765|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52931|NCT02065453|B2|Baseline|Disposable Device Right and Reusable Devices Left|25 women were randomized to receive disposable device right and reusable devices left
52766|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52974|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52767|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52768|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52769|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52770|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52771|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52772|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52773|NCT02067728|E2|Reported Event|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.
FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
52774|NCT02067728|E1|Reported Event|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool
Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
52775|NCT02067585|B4|Baseline|Total|Total of all reporting groups
52776|NCT02067585|B3|Baseline|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52777|NCT02067585|B2|Baseline|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52778|NCT02067585|B1|Baseline|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52779|NCT02067585|P3|Participant Flow|Control|no-operated
52780|NCT02067585|P2|Participant Flow|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52781|NCT02067585|P1|Participant Flow|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52782|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52783|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52784|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52785|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52786|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
53159|NCT02064231|O1|Outcome|Coloplast Test A|Subjects testing Test A
52866|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
53703|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
52787|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52788|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52789|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52790|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52791|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52792|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52793|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52794|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52795|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52796|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52797|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52798|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52799|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52800|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52801|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52802|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52803|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52804|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52805|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52932|NCT02065453|B1|Baseline|Disposable Device Left and Resusable Devices Right|27 women were randomized to receive disposable device left and resusable devices right
52806|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52807|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52808|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52809|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52810|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52811|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52812|NCT02067585|E3|Reported Event|Control|"Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52813|NCT02067585|E2|Reported Event|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52814|NCT02067585|E1|Reported Event|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
52815|NCT02067533|B3|Baseline|Total|Total of all reporting groups
52816|NCT02067533|B2|Baseline|Extension Position|soft tissue repair in extension position
52817|NCT02067533|B1|Baseline|Flexion Position|soft tissue repair in flexion position
52818|NCT02067533|P2|Participant Flow|Extension Position|soft tissue repair in extension position
52819|NCT02067533|P1|Participant Flow|Flexion Position|soft tissue repair in flexion position
52820|NCT02067533|O2|Outcome|Extension Position|soft tissue repair in extension position
52821|NCT02067533|O1|Outcome|Flexion Position|soft tissue repair in flexion position
52822|NCT02067533|E2|Reported Event|Extension Position|soft tissue repair in extension position
52823|NCT02067533|E1|Reported Event|Flexion Position|soft tissue repair in flexion position
52824|NCT02067273|B3|Baseline|Total|Total of all reporting groups
52825|NCT02067273|B2|Baseline|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days
Transcranial Magnetic Stimulation (TMS)"
52826|NCT02067273|B1|Baseline|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Transcranial Magnetic Stimulation (TMS)"
52827|NCT02067273|P2|Participant Flow|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days
Transcranial Magnetic Stimulation (TMS)"
52828|NCT02067273|P1|Participant Flow|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Transcranial Magnetic Stimulation (TMS)"
52829|NCT02067273|O2|Outcome|TMS Intervention (5 Days)|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days
Transcranial Magnetic Stimulation (TMS)"
52830|NCT02067273|O1|Outcome|TMS Intervention (1 Day)|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Transcranial Magnetic Stimulation (TMS)"
52831|NCT02067273|E2|Reported Event|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days
Transcranial Magnetic Stimulation (TMS)"
52832|NCT02067273|E1|Reported Event|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Transcranial Magnetic Stimulation (TMS)"
52833|NCT02066922|B1|Baseline|DAILIES TOTAL1/TRUEYE|Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
52834|NCT02066922|P1|Participant Flow|DAILIES TOTAL1/TRUEYE|Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
52835|NCT02066922|O2|Outcome|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
52836|NCT02066922|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
52837|NCT02066922|O2|Outcome|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
52838|NCT02066922|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
52839|NCT02066922|E2|Reported Event|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
52840|NCT02066922|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
52841|NCT02066896|B3|Baseline|Total|Total of all reporting groups
53160|NCT02064231|E5|Reported Event|Own Product|Subjects collecting data on own product
52842|NCT02066896|B2|Baseline|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
52843|NCT02066896|B1|Baseline|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
52844|NCT02066896|P2|Participant Flow|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
52845|NCT02066896|P1|Participant Flow|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
52846|NCT02066896|O2|Outcome|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
52847|NCT02066896|O1|Outcome|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
52848|NCT02066896|O2|Outcome|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
52849|NCT02066896|O1|Outcome|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
52850|NCT02066896|O2|Outcome|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
52851|NCT02066896|O1|Outcome|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
52852|NCT02066896|E2|Reported Event|Active Comparator: Lasertherapy|"Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)"
52853|NCT02066896|E1|Reported Event|Sham Comparator: Sham Lasertherapy|"Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group)."
52854|NCT02066857|B3|Baseline|Total|Total of all reporting groups
52855|NCT02066857|B2|Baseline|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
52856|NCT02066857|B1|Baseline|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
52857|NCT02066857|P2|Participant Flow|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
52858|NCT02066857|P1|Participant Flow|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
52859|NCT02066857|O2|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
52860|NCT02066857|O1|Outcome|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
52861|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
52862|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
52863|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
52864|NCT02066857|O2|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
52865|NCT02066857|O1|Outcome|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
52971|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52867|NCT02066857|O2|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
52868|NCT02066857|O1|Outcome|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
52869|NCT02066857|E2|Reported Event|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
52870|NCT02066857|E1|Reported Event|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
52871|NCT02066740|B1|Baseline|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
52872|NCT02066740|P1|Participant Flow|EverFlex™ Stent With Entrust™ Delivery System|Subjects were treated with the EverFlex™ stent with Entrust™ delivery system
52873|NCT02066740|O1|Outcome|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
52874|NCT02066740|O1|Outcome|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
52875|NCT02066740|E1|Reported Event|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
52876|NCT02066727|B3|Baseline|Total|Total of all reporting groups
52877|NCT02066727|B2|Baseline|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
52878|NCT02066727|B1|Baseline|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
52879|NCT02066727|P2|Participant Flow|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
52880|NCT02066727|P1|Participant Flow|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
52881|NCT02066727|O2|Outcome|Dexmedetomidine|"Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
Dexmedetomidine: Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg."
52882|NCT02066727|O1|Outcome|Normal Saline|"Normal Saline is administrated as an adjuvant of lidocaine.
Normal Saline: Normal Saline is administrated as an adjuvant of lidocaine."
52883|NCT02066727|E2|Reported Event|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
52884|NCT02066727|E1|Reported Event|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
52885|NCT02066402|B3|Baseline|Total|Total of all reporting groups
52886|NCT02066402|B2|Baseline|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52887|NCT02066402|B1|Baseline|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52888|NCT02066402|P2|Participant Flow|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52889|NCT02066402|P1|Participant Flow|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52890|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52891|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52892|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52893|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52894|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52895|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52896|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52897|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52898|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52899|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52900|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52901|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52902|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52903|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52904|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52905|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52906|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52907|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52909|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52911|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52912|NCT02066402|E2|Reported Event|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
52913|NCT02066402|E1|Reported Event|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
52914|NCT02066233|B3|Baseline|Total|Total of all reporting groups
52915|NCT02066233|B2|Baseline|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
52916|NCT02066233|B1|Baseline|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
52917|NCT02066233|P2|Participant Flow|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
52918|NCT02066233|P1|Participant Flow|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
52919|NCT02066233|O2|Outcome|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
52920|NCT02066233|O1|Outcome|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
52921|NCT02066233|O2|Outcome|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
52922|NCT02066233|O1|Outcome|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
52923|NCT02066233|E2|Reported Event|Subjects With Reflux and/or Heartburn|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
52924|NCT02066233|E1|Reported Event|Subjects With Barrett's Esophagus|All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
52925|NCT02066051|B1|Baseline|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.
IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.
Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
52926|NCT02066051|P1|Participant Flow|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.
IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.
Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
52927|NCT02066051|O1|Outcome|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.
IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.
Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
52928|NCT02066051|O1|Outcome|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.
IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.
Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
52929|NCT02066051|E1|Reported Event|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.
IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.
Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
52930|NCT02065453|B3|Baseline|Total|Total of all reporting groups
53161|NCT02064231|E4|Reported Event|Coloplast Test D|Subjects testing Test D
52933|NCT02065453|P2|Participant Flow|Disposable Device - Right & Reusable Devices - Left|25 women were randomized to attending physicians using the disposable device on the right and reusable devices on the left
52975|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52934|NCT02065453|P1|Participant Flow|Disposable Device - Left & Reusable Devices - Right|27 women were randomized to attending physicians using the disposable device on the left and reusable devices on the right.
52935|NCT02065453|O2|Outcome|Reusable|Uterine Vessel Desiccation and Electrosurgical Cutting Time (min) Resident and Attending Physicians Combined
52936|NCT02065453|O1|Outcome|Disposable|Uterine Vessel Desiccation and Electrosurgical Cutting Time (min) Resident and Attending Physicians Combined
52937|NCT02065453|E1|Reported Event|Disposable or Reusable Energy Sources|Each patient serve as their own control. One side of the uterine attachments would be transected using the disposable device, the Ligasure, and the other using the two reusable devices, the Robi bipolar and Storz laparoscopic shears. It is our standard practice that the attending surgeon is on the patient's left side while the resident physician is on the patients right. To eliminate the bias of surgical experience, we will randomize the energy source used on each side for every case. Therefore, the number of cases performed by the attending surgeon with the disposable or reusable energy sources, will equal that of the less experienced resident surgeon.
52938|NCT02064985|B4|Baseline|Total|Total of all reporting groups
52939|NCT02064985|B3|Baseline|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52940|NCT02064985|B2|Baseline|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52941|NCT02064985|B1|Baseline|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52942|NCT02064985|P3|Participant Flow|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52943|NCT02064985|P2|Participant Flow|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52944|NCT02064985|P1|Participant Flow|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52945|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52946|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52947|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52948|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52949|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52950|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52951|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52952|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52953|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52954|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52955|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52956|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52957|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52958|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52959|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52960|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52961|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52962|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52963|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52964|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52965|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52966|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52967|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52968|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52969|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52970|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53162|NCT02064231|E3|Reported Event|Coloplast Test C|Subjects testing Test C
52973|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53704|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
52976|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52977|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52978|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52979|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52980|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52981|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52982|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52983|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52984|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52985|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52986|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52987|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52988|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52989|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52990|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52991|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52992|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52993|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52994|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52995|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52996|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
52997|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
52998|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
52999|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53000|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53001|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53002|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53003|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53004|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53005|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53006|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53007|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53008|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53009|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53010|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53011|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53012|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53013|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53163|NCT02064231|E2|Reported Event|Coloplast Test B|Subjects testing Test B
53014|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53015|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53016|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53017|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53018|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53019|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53020|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53021|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53022|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53023|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53024|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53025|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53026|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53027|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53028|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53029|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53030|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53031|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53032|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53033|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53034|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53035|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53036|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53037|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53038|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53039|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53040|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53041|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53042|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53043|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53044|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53045|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53046|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53047|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53048|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53049|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53050|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53051|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53052|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53053|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53054|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53164|NCT02064231|E1|Reported Event|Coloplast Test A|Subjects testing Test A
53055|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53056|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53057|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53058|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53059|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53060|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53061|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53062|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53063|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53064|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53065|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53066|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53067|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53068|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53069|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53070|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53071|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53072|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53073|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53074|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53075|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53076|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53077|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53078|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53079|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53080|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53081|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53082|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53083|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53084|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53085|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53086|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53087|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53088|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53089|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53090|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53091|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53092|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53093|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53094|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53095|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53442|NCT02062580|P1|Participant Flow|Delayed BCG|"BCG delayed to 8 weeks of age
BCG"
53096|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53097|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53098|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53099|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53100|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53101|NCT02064985|E3|Reported Event|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
53102|NCT02064985|E2|Reported Event|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
53103|NCT02064985|E1|Reported Event|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
53104|NCT02064920|B3|Baseline|Total|Total of all reporting groups
53105|NCT02064920|B2|Baseline|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
53106|NCT02064920|B1|Baseline|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
53107|NCT02064920|P2|Participant Flow|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
53108|NCT02064920|P1|Participant Flow|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
53109|NCT02064920|O2|Outcome|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
53110|NCT02064920|O1|Outcome|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
53111|NCT02064920|O2|Outcome|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
53112|NCT02064920|O1|Outcome|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
53113|NCT02064920|E2|Reported Event|Donepezil|During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
53114|NCT02064920|E1|Reported Event|Placebo|Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
53115|NCT02064907|B3|Baseline|Total|Total of all reporting groups
53116|NCT02064907|B2|Baseline|Dexlansoprazole Capsules + Dexlansoprazole OD Tablets|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
53117|NCT02064907|B1|Baseline|Dexlansoprazole OD Tablets + Dexlansoprazole Capsules|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
53118|NCT02064907|P2|Participant Flow|Dexlansoprazole Capsules + Dexlansoprazole OD Tablets|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
53119|NCT02064907|P1|Participant Flow|Dexlansoprazole OD Tablets + Dexlansoprazole Capsules|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
53120|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
53121|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
53122|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
53123|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
53124|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
53125|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
53126|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
53127|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
53128|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
53129|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
53130|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
53131|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
53132|NCT02064907|E2|Reported Event|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
53133|NCT02064907|E1|Reported Event|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
53134|NCT02064894|B4|Baseline|Total|Total of all reporting groups
53135|NCT02064894|B3|Baseline|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study
Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
53451|NCT02062502|B1|Baseline|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53136|NCT02064894|B2|Baseline|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study
Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
53137|NCT02064894|B1|Baseline|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame
oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
53138|NCT02064894|P3|Participant Flow|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study
Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
53139|NCT02064894|P2|Participant Flow|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study
Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
53140|NCT02064894|P1|Participant Flow|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame
oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
53141|NCT02064894|O3|Outcome|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study
Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
53142|NCT02064894|O2|Outcome|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study
Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
53143|NCT02064894|O1|Outcome|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame
oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
53144|NCT02064894|O3|Outcome|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study
Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
53145|NCT02064894|O2|Outcome|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study
Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
53146|NCT02064894|O1|Outcome|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame
oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
53147|NCT02064894|E3|Reported Event|Ibuprofen and Placebo of Morphine|"Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study
Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator"
53148|NCT02064894|E2|Reported Event|Morphine and Placebo of Ibuprofen|"Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study
Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study"
53149|NCT02064894|E1|Reported Event|Oral Morphine and Oral Ibuprofen|"Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame
oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group"
53150|NCT02064231|B1|Baseline|Overall Study Population|
53151|NCT02064231|P4|Participant Flow|Oloplast Test A, Coloplast Test D, Own Product|"The subjects first test Coloplast Test A and thereafter Coloplast Test D and finally their own product for 14 days
Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test D: Coloplast Test D is a newly developed ostomy appliance developed by Coloplast A/S
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
53152|NCT02064231|P3|Participant Flow|Coloplast Test D, Coloplast Test C, Own Product|"The subjects first test Coloplast Test D and thereafter Coloplast Test C and finally their own product for 14 days
Coloplast Test D: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test C: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
53153|NCT02064231|P2|Participant Flow|Coloplast Test C , Coloplast Test D, Own Product|"The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
Coloplast Test C: Coloplast Test C is a new ostomy appliance developed by Coloplast A/S
Coloplast Test D: Coloplast Test D is a new ostomy appliance developed by Coloplast A/S"
53154|NCT02064231|P1|Participant Flow|Coloplast Test A, Coloplast Test B, Own Product|"The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days
Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
53155|NCT02064231|O5|Outcome|Own Product|Subjects collecting data on own product
53156|NCT02064231|O4|Outcome|Coloplast Test D|Subjects testing Test D
53157|NCT02064231|O3|Outcome|Coloplast Test C|Subjects testing Test C
53158|NCT02064231|O2|Outcome|Coloplast Test B|Subjects testing Test B
53165|NCT02064205|B1|Baseline|Overall Baseline Charactistics of 32 Slightly Overweight Women|Baseline data of the subjects were measured at screening at least one week before the start of the study.
53705|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53166|NCT02064205|P1|Participant Flow|All Study Participants|"A: Breakfast with the pre-load and 12.5 g polydextrose B:Breakfast with the pre-load without polydextrose C: Breakfast and pre-load with 12.5 g polydextrose at 150 min D:Breakfast and pre-load without polydextrose at t=150 min
Eight orders:
A-B-D-C; B-C-A-D; C-D-B-A; D-A-C-B; A-D-B-C; C-B-D-A; B-A-C-D; D-C-A-B."
53167|NCT02064205|O2|Outcome|Glucose Syrup at Breakfast (Control) [B]|Breakfast with glucose syrup and yogurt provided four hours before lunch.
53168|NCT02064205|O1|Outcome|Polydextrose Syrup at Breakfast [A]|Breakfast with polydextrose and yogurt provided four hours before lunch.
53169|NCT02064205|O4|Outcome|Pre-load With Glucose Syrup Before Lunch [D]|Pre-load with glucose syrup and yogurt was provided 1.5h before lunch.
53170|NCT02064205|O3|Outcome|Pre-load With Polydextrose Before Lunch [C]|Pre-load with polydextrose syrup and yogurt is provided 1.5h before lunch
53171|NCT02064205|O2|Outcome|Glucose Syrup as Proload With Breakfast (Control) [B]|Breakfast with glucose syrup and yogurt provided four hours before lunch.
53172|NCT02064205|O1|Outcome|Polydextrose Syrup Preload With Yogurt With Breakfast [A]|Polydextrose syrup preload with yogurt with breakfast was consumed four hours before lunch
53173|NCT02064205|O4|Outcome|Pre-load With Yogurt and Glucose Before Lunch [D]|"Breakfast without pre-load. Pre-load with yogurt and glucose (control) provided 1.5h before lunch.
Yogurt with control (glucose syrup) is tested for its satiating effect 1.5h before lunch"
53174|NCT02064205|O3|Outcome|Pre-load With Polydextroseglucose Before Lunch [C]|"Breakfast without pre-load. Pre-load with yogurt and polydextrose provided 1.5h before lunch.
12.5 g polydextrose: Appetite suppressing supplement is added in yogurt 1.5h before lunch."
53175|NCT02064205|O2|Outcome|Glucose Syrup at Breakfast (Control) [B]|"Breakfast with control pre-load four hours before lunch
Yogurt with control (glucose syrup) is tested for its satiating effect.
glucose syrup: Glucose syrup is used a control product for the polydextrose"
53176|NCT02064205|O1|Outcome|Polydextrose Syrup at Breakfast [A]|"Breakfast with pre-load four hours before lunch
12.5 g polydextrose: Appetite suppressing supplement is added in yogurt and provided with breakfast, four hours before lunch."
53177|NCT02064205|E4|Reported Event|Condition D|Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and glucose syrup
53178|NCT02064205|E3|Reported Event|Condition C|Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and polydextrose
53179|NCT02064205|E2|Reported Event|Condition B|Breakfast with preload of yogurt and glucose control
53180|NCT02064205|E1|Reported Event|Condition A|Breakfast with preload of yogurt and polydextrose
53181|NCT02063880|B3|Baseline|Total|Total of all reporting groups
53182|NCT02063880|B2|Baseline|Early ART|"Initiation of HAART 7-14 days after enrollment.
Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
53183|NCT02063880|B1|Baseline|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.
Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.
Urgent ART: Children will be started on HAART <48 hours after enrollment."
53184|NCT02063880|P2|Participant Flow|Early ART|"Initiation of HAART 7-14 days after enrollment.
Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
53185|NCT02063880|P1|Participant Flow|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.
Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.
Urgent ART: Children will be started on HAART <48 hours after enrollment."
53186|NCT02063880|O2|Outcome|Early ART|"Initiation of HAART 7-14 days after enrollment.
Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
53187|NCT02063880|O1|Outcome|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.
Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.
Urgent ART: Children will be started on HAART <48 hours after enrollment."
53188|NCT02063880|O2|Outcome|Early ART|"Initiation of HAART 7-14 days after enrollment.
Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
53189|NCT02063880|O1|Outcome|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.
Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.
Urgent ART: Children will be started on HAART <48 hours after enrollment."
53190|NCT02063880|O2|Outcome|Early ART|"Initiation of HAART 7-14 days after enrollment.
Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
53191|NCT02063880|O1|Outcome|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.
Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.
Urgent ART: Children will be started on HAART <48 hours after enrollment."
53192|NCT02063880|E2|Reported Event|Early ART|"Initiation of HAART 7-14 days after enrollment.
Early ART: Children will be started on ART after stabilization 7-14 days after enrollment."
53193|NCT02063880|E1|Reported Event|Urgent ART|"Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment.
Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.
Urgent ART: Children will be started on HAART <48 hours after enrollment."
53194|NCT02063854|B8|Baseline|Total|Total of all reporting groups
53195|NCT02063854|B7|Baseline|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53196|NCT02063854|B6|Baseline|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53575|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53197|NCT02063854|B5|Baseline|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53198|NCT02063854|B4|Baseline|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53199|NCT02063854|B3|Baseline|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53200|NCT02063854|B2|Baseline|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53201|NCT02063854|B1|Baseline|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53202|NCT02063854|P7|Participant Flow|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53203|NCT02063854|P6|Participant Flow|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53204|NCT02063854|P5|Participant Flow|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53205|NCT02063854|P4|Participant Flow|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53206|NCT02063854|P3|Participant Flow|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53207|NCT02063854|P2|Participant Flow|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53208|NCT02063854|P1|Participant Flow|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53209|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53210|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53443|NCT02062580|O2|Outcome|Early BCG|"BCG at birth; standard of care
BCG"
53444|NCT02062580|O1|Outcome|Delayed BCG|"BCG delayed to 8 weeks of age
BCG"
53211|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53212|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53213|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53214|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53215|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53216|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53217|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53218|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53219|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53220|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53221|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53222|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53223|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53224|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53305|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53225|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53226|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53227|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53228|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53229|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53230|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53231|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53232|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53233|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53234|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53235|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53236|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53237|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53238|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53317|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53239|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53240|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53241|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53242|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53243|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53244|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53245|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53246|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53247|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53248|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53249|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53250|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53251|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53252|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53371|NCT02063230|E3|Reported Event|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
53372|NCT02063230|E2|Reported Event|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
53253|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53254|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53255|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53256|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53257|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53258|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53259|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53260|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53261|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53262|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53263|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53264|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53265|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53266|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53373|NCT02063230|E1|Reported Event|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
53374|NCT02063035|B3|Baseline|Total|Total of all reporting groups
53445|NCT02062580|O2|Outcome|Early BCG|"BCG at birth; standard of care
BCG"
53267|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53268|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53269|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53270|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53271|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53272|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53273|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53274|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53275|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53276|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53277|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53278|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53279|NCT02063854|O3|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53280|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53375|NCT02063035|B2|Baseline|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53281|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53282|NCT02063854|E7|Reported Event|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53283|NCT02063854|E6|Reported Event|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53284|NCT02063854|E5|Reported Event|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53285|NCT02063854|E4|Reported Event|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53286|NCT02063854|E3|Reported Event|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53287|NCT02063854|E2|Reported Event|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53288|NCT02063854|E1|Reported Event|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
53289|NCT02063737|B3|Baseline|Total|Total of all reporting groups
53290|NCT02063737|B2|Baseline|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53291|NCT02063737|B1|Baseline|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53292|NCT02063737|P2|Participant Flow|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53293|NCT02063737|P1|Participant Flow|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53376|NCT02063035|B1|Baseline|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53377|NCT02063035|P2|Participant Flow|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
97400|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
53294|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53295|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53296|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53297|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53298|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53299|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53300|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53301|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53302|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53303|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53304|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53446|NCT02062580|O1|Outcome|Delayed BCG|"BCG delayed to 8 weeks of age
BCG"
53447|NCT02062580|E2|Reported Event|Early BCG|"BCG at birth; standard of care
BCG"
53306|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53307|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53308|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53309|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53310|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53311|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53312|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53313|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53314|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53315|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53316|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53448|NCT02062580|E1|Reported Event|Delayed BCG|"BCG delayed to 8 weeks of age
BCG"
53449|NCT02062502|B3|Baseline|Total|Total of all reporting groups
53318|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53319|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53320|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53321|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53322|NCT02063737|E2|Reported Event|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
53323|NCT02063737|E1|Reported Event|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
53324|NCT02063516|B3|Baseline|Total|Total of all reporting groups
53325|NCT02063516|B2|Baseline|Proseal|"Device:Proseal Laryngeal Mask Airway
Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
53326|NCT02063516|B1|Baseline|Guardian|"Device: Guardian Laryngeal Mask
Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
53327|NCT02063516|P2|Participant Flow|Proseal|"Device:Proseal Laryngeal Mask Airway
Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
53328|NCT02063516|P1|Participant Flow|Guardian|"Device: Guardian Laryngeal Mask
Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
53329|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway
Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
53330|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask
Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
53331|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway
Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
53378|NCT02063035|P1|Participant Flow|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 grams (g) tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53450|NCT02062502|B2|Baseline|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53332|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask
Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
53333|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway
Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
53334|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask
Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
53335|NCT02063516|E2|Reported Event|Proseal|"Device:Proseal Laryngeal Mask Airway
Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
53336|NCT02063516|E1|Reported Event|Guardian|"Device: Guardian Laryngeal Mask
Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
53337|NCT02063230|B5|Baseline|Total|Total of all reporting groups
53338|NCT02063230|B4|Baseline|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
53339|NCT02063230|B3|Baseline|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
53340|NCT02063230|B2|Baseline|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
53341|NCT02063230|B1|Baseline|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
53342|NCT02063230|P4|Participant Flow|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
53343|NCT02063230|P3|Participant Flow|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
53344|NCT02063230|P2|Participant Flow|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
53345|NCT02063230|P1|Participant Flow|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
53346|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
53347|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
53348|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
53349|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
53350|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
53351|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
53352|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
53353|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
53354|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
53355|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
53356|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
53357|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
53358|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
53359|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
53360|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
53361|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
53362|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
53363|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
53364|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
53365|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
53366|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
53367|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
53368|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
53369|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
53370|NCT02063230|E4|Reported Event|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
97563|NCT01797380|E1|Reported Event|Sugar Pill|Placebo
53379|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53380|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53381|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53382|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53383|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53384|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53385|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53386|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53387|NCT02063035|E2|Reported Event|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53388|NCT02063035|E1|Reported Event|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
53389|NCT02062905|B3|Baseline|Total|Total of all reporting groups
53390|NCT02062905|B2|Baseline|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug
Placebo Plug with no drug"
53391|NCT02062905|B1|Baseline|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment"
53392|NCT02062905|P2|Participant Flow|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug
Placebo Plug with no drug"
53393|NCT02062905|P1|Participant Flow|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment"
53394|NCT02062905|O2|Outcome|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug
Placebo Plug with no drug"
53395|NCT02062905|O1|Outcome|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment"
53396|NCT02062905|O2|Outcome|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug
Placebo Plug with no drug"
53397|NCT02062905|O1|Outcome|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment"
53398|NCT02062905|E2|Reported Event|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug
Placebo Plug with no drug"
53399|NCT02062905|E1|Reported Event|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment"
53400|NCT02062801|B3|Baseline|Total|Total of all reporting groups
53401|NCT02062801|B2|Baseline|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion
Placebo"
53402|NCT02062801|B1|Baseline|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion
Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
53403|NCT02062801|P2|Participant Flow|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion
Placebo"
53404|NCT02062801|P1|Participant Flow|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion
Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
53405|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion
Placebo"
53406|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion
Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
53407|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion
Placebo"
53408|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion
Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
53409|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion
Placebo"
53410|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion
Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
53411|NCT02062801|E2|Reported Event|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion
Placebo"
53439|NCT02062580|B2|Baseline|Early BCG|"BCG at birth; standard of care
BCG"
53412|NCT02062801|E1|Reported Event|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion
Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
53413|NCT02062710|B1|Baseline|Diphenhydramine/Phenylephrine/Cocoa, Dextromethorphan,Placebo|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; dextromethorphan; placebo.
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.
Phenylephrine: 10 mg dose phenylephrine
Diphenhydramine: 25 mg dose diphenhydramine
Dextromethorphan: 30 mg dose dextromethorphan"
53414|NCT02062710|P6|Participant Flow|Placebo, Dextromethorphan, Then Diphenhydramine/Phenylephrine/|"placebo, then dextromethorphan 30 mg, then diphenhydramine 25 mg and phenylephrine 10 mg.
Intervention: capsaicin cough challenge 2 hours after study drug administration.
Washout period 1-2 days after each of the 3 dosing periods."
53415|NCT02062710|P5|Participant Flow|Placebo, Diphenhydramine/Phenylephrine/Cocoa, Then Dextrometho|"placebo, then diphenhydramine 25 mg and phenylephrine 10 mg, then dextromethorphan 30 mg.
Intervention: capsaicin cough challenge 2 hours after study drug administration.
Washout period 1-2 days after each of the 3 dosing periods"
53416|NCT02062710|P4|Participant Flow|Dextromethorphan, Placebo, Then Diphenhydramine/Phenylephrine/|"dextromethorphan 30 mg, then placebo, then diphenhydramine 25 mg and phenylephrine 10 mg.
Intervention: capsaicin cough challenge 2 hours after study drug ingestion. Washout period 1-2 days between each of the 3 dosing periods"
53417|NCT02062710|P3|Participant Flow|Dextromethorphan, Diphenhydramine/Phenylephrine/Cocoa, Then pl|dextromethorphan 30 mg, then diphenhydramine/phenylephrine/cocoa, then placebo. Intervention: capsaicin cough challeneg 2 hours after study drug ingestion
53418|NCT02062710|P2|Participant Flow|Diphenhydramine/Phenylephrine/Cocoa, Then Placebo, Then Dextro|"diphenhydramine 25 mg and phenylephrine 10 mg; then placebo; then dextromethorphan 30 mg.
Intervention: capsaicin cough challenge testing after study drug ingestion"
53419|NCT02062710|P1|Participant Flow|Diphenhydramine/Phen/Cocoa, Dextromethorphan, Then Placebo|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; then dextromethorphan 30 mg; then placebo.
Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.
Washout 1-2 days between each of the 3 dosing periods."
53420|NCT02062710|O3|Outcome|Placebo|placebo liquid, dextrose in water, 20 mL
53421|NCT02062710|O2|Outcome|Dextromethorphan|"Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.
Dextromethorphan: 30 mg dose dextromethorphan"
53422|NCT02062710|O1|Outcome|Diphenhydramine/Phenylephrine/Cocoa|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.
Phenylephrine: 10 mg dose phenylephrine
Diphenhydramine: 25 mg dose diphenhydramine"
53423|NCT02062710|E3|Reported Event|Placebo|placebo liquid, dextrose in water, 20 mL
53424|NCT02062710|E2|Reported Event|Dextromethorphan|"Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.
Dextromethorphan: 30 mg dose dextromethorphan"
53425|NCT02062710|E1|Reported Event|Diphenhydramine/Phenylephrine/Cocoa|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.
Phenylephrine: 10 mg dose phenylephrine
Diphenhydramine: 25 mg dose diphenhydramine"
53426|NCT02062658|B1|Baseline|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
Ketamine: 0.5mg/kg IV
Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
53427|NCT02062658|P1|Participant Flow|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
Ketamine: 0.5mg/kg IV
Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
53428|NCT02062658|O1|Outcome|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
Ketamine: 0.5mg/kg IV
Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
53429|NCT02062658|E1|Reported Event|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
Ketamine: 0.5mg/kg IV
Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
53430|NCT02062645|B1|Baseline|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
53431|NCT02062645|P1|Participant Flow|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
53432|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
53433|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
53434|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
53435|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
53436|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
53437|NCT02062645|E1|Reported Event|Amlodipine/Valsartan|amlodipine/valsartan
53438|NCT02062580|B3|Baseline|Total|Total of all reporting groups
53452|NCT02062502|P2|Participant Flow|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53453|NCT02062502|P1|Participant Flow|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53454|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53455|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53456|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53457|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53458|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53459|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53460|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53461|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53462|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53463|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53464|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53465|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53466|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53467|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53468|NCT02062502|E2|Reported Event|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53469|NCT02062502|E1|Reported Event|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
53470|NCT02062450|B3|Baseline|Total|Total of all reporting groups
53471|NCT02062450|B2|Baseline|Revision Surgery|Patients who underwent a revision hip replacement surgery with Dual Mobility Cup
53472|NCT02062450|B1|Baseline|Primary Surgery|Patients who underwent a primary hip replacement surgery with Dual Mobility Cup
53473|NCT02062450|P1|Participant Flow|Hip Acetabular Replacement, Using a Dual Mobility Cup.|"Studied cohort includes 2 subgroups :
Patients with primary hip replacement.
Patients with revision surgery."
53474|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
53475|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
53476|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
53477|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
53478|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
53479|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
53480|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
53481|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
53482|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
53483|NCT02062450|E3|Reported Event|Revision Surgery Sub-group|Patients who underwent a Revision Hip Replacement surgery
53484|NCT02062450|E2|Reported Event|Primary Surgery Sub-group|Patients who underwent a Primary Hip Replacement surgery
53485|NCT02062450|E1|Reported Event|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
53486|NCT02062437|B1|Baseline|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
53682|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53574|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53487|NCT02062437|P1|Participant Flow|Total Hip Replacement Using a Ceramic Friction Pair|All patients were treated with a total hip replacement using a ceramic friction pair Biolox® delta, with a Meije Duo® cementless stem with HAP associated with a cementless double coating of plasma sprayed titanium and HAP Dynacup® acetabular cup.
53488|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
53489|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
53490|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
53491|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
53492|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
53493|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
53494|NCT02062437|E1|Reported Event|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
53495|NCT02062385|B5|Baseline|Total|Total of all reporting groups
53496|NCT02062385|B4|Baseline|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53497|NCT02062385|B3|Baseline|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53498|NCT02062385|B2|Baseline|Placebo With Staggered EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
53499|NCT02062385|B1|Baseline|V260 With Staggered EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
53500|NCT02062385|P4|Participant Flow|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53501|NCT02062385|P3|Participant Flow|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53502|NCT02062385|P2|Participant Flow|Placebo With Staggered EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
53503|NCT02062385|P1|Participant Flow|V260 With Staggered EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered China Expanded Program on Immunization (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
53504|NCT02062385|O2|Outcome|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53505|NCT02062385|O1|Outcome|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53506|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53507|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53508|NCT02062385|O2|Outcome|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53509|NCT02062385|O1|Outcome|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53572|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53683|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53510|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53511|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53512|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53513|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53514|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53515|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53516|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53517|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53518|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53519|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53520|NCT02062385|E2|Reported Event|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53521|NCT02062385|E1|Reported Event|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
53522|NCT02062359|B1|Baseline|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.
On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: On days"
53573|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53684|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53523|NCT02062359|P1|Participant Flow|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.
On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: On days"
53524|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.
On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: On days"
53525|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.
On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: On days"
53526|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.
On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: On days"
53527|NCT02062359|E1|Reported Event|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.
On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: On days"
53528|NCT02062294|B1|Baseline|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
53529|NCT02062294|P1|Participant Flow|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
53530|NCT02062294|O1|Outcome|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
53531|NCT02062294|O1|Outcome|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
53532|NCT02062294|E1|Reported Event|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
53533|NCT02062177|B3|Baseline|Total|Total of all reporting groups
53534|NCT02062177|B2|Baseline|Midazolam Group|"70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years).
35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
53535|NCT02062177|B1|Baseline|Propofol Group|"70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient’s body weight and general condition.
35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control.
Patients in this group received placebo boluses with normal saline to warrant blindness to the randomization group of both patient and endoscopist. (because of the well-known difference in the physical appearance of the study drugs, to maintain blindness of endoscopist, a fabric curtain was drawn across patient’s arm covering the i.v. line and TCI pump)."
53536|NCT02062177|P2|Participant Flow|Midazolam Group|"A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years).
35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
53678|NCT02061358|P4|Participant Flow|90 mg UV-4B|UV-4B 90 mg oral, single dose
53537|NCT02062177|P1|Participant Flow|Propofol Group|"A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient’s body weight and general condition.
35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
53538|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
53539|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
53540|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
53541|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
53542|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
53543|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
53544|NCT02062177|E2|Reported Event|Midazolam Group; n=35, 35|35 upper endoscopy 35 colonoscopy
53545|NCT02062177|E1|Reported Event|Propofol Group; n=35, 35|35 upper endoscopy 35 colonoscopy
53546|NCT02061748|B3|Baseline|Total|Total of all reporting groups
53547|NCT02061748|B2|Baseline|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53548|NCT02061748|B1|Baseline|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53549|NCT02061748|P2|Participant Flow|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53550|NCT02061748|P1|Participant Flow|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53551|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53552|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53553|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53554|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53555|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53556|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53557|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53558|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53559|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53560|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53561|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53562|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53563|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53564|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53565|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53566|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53567|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53568|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53569|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53570|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53571|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53679|NCT02061358|P3|Participant Flow|30 mg UV-4B|UV-4B 30 mg oral, single dose
53576|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53577|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53578|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53579|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53580|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53581|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53582|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53583|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53584|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53585|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53586|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53587|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53588|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53589|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53590|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53591|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53592|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53593|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53594|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53595|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53596|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53597|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53598|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53599|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53600|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53601|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53602|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53603|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53685|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53604|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53605|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53606|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53607|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53608|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53609|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53610|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53611|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53612|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53613|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53614|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53615|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53616|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53617|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53618|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53619|NCT02061748|E2|Reported Event|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
53620|NCT02061748|E1|Reported Event|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
53621|NCT02061696|B3|Baseline|Total|Total of all reporting groups
53622|NCT02061696|B2|Baseline|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
53623|NCT02061696|B1|Baseline|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Standard Manual Compression: Closure procedure by Manual Compression"
53624|NCT02061696|P2|Participant Flow|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
53625|NCT02061696|P1|Participant Flow|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Standard Manual Compression: Closure procedure by Manual Compression"
53626|NCT02061696|O2|Outcome|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
53627|NCT02061696|O1|Outcome|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Standard Manual Compression: Closure procedure by Manual Compression"
53628|NCT02061696|E2|Reported Event|AXERA 2 Access System|"The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression"
53629|NCT02061696|E1|Reported Event|Standard Manual Compression|"Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Standard Manual Compression: Closure procedure by Manual Compression"
53630|NCT02061683|B1|Baseline|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
53631|NCT02061683|P1|Participant Flow|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
53632|NCT02061683|O1|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
53633|NCT02061683|O1|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
53634|NCT02061683|E1|Reported Event|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
53635|NCT02061592|B3|Baseline|Total|Total of all reporting groups
53680|NCT02061358|P2|Participant Flow|10 mg UV-4B|UV-4B 10 mg oral, single dose
53681|NCT02061358|P1|Participant Flow|3 mg UV-4B|UV-4B 3 mg oral, single dose
53636|NCT02061592|B2|Baseline|Test/Control|Subjects first received the test lens, etafilcon A , for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
53693|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53694|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53637|NCT02061592|B1|Baseline|Control/Test|Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
53638|NCT02061592|P2|Participant Flow|Test/Control|Subjects first received the test lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
53639|NCT02061592|P1|Participant Flow|Control/Test|Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
53640|NCT02061592|O2|Outcome|Test|Subjects who received Test lens, etafilcon A , in either the first week or last week of the study.
53641|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
53642|NCT02061592|O2|Outcome|Test|Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
53643|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
53644|NCT02061592|O2|Outcome|Test|Subjects who received Test lens, etafilcon A, in either the first week or last week of the study.
53645|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
53646|NCT02061592|O2|Outcome|Test|Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
53647|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
53648|NCT02061592|E2|Reported Event|Test|Subjects who received the test lens, etafilcon A, in either the first week or the last week of the study.
53649|NCT02061592|E1|Reported Event|Control|Subjects who received control lens etafilcon A in either the first or the last week of the study .
53650|NCT02061540|B1|Baseline|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
53651|NCT02061540|P1|Participant Flow|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
53652|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
53653|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
53654|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
53655|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
53656|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
53657|NCT02061540|O5|Outcome|Maralixibat (LUM001) 10 mg|Participants received LUM001 tablet orally once daily at a dose of 10 mg during Week 6 of the treatment period followed by stable dosing of 10 mg for 8 weeks.
53658|NCT02061540|O4|Outcome|Maralixibat (LUM001) 7.5 mg|Participants received LUM001 tablet orally once daily at a dose of 7.5 mg during Week 5 of the treatment period.
53659|NCT02061540|O3|Outcome|Maralixibat (LUM001) 5 mg|Participants received LUM001 tablet orally once daily at a dose of 5 mg during Week 4 of the treatment period.
53660|NCT02061540|O2|Outcome|Maralixibat (LUM001) 2.5 mg|Participants received LUM001 tablet orally once daily at a dose of 2.5 mg during Week 3 of the treatment period.
53661|NCT02061540|O1|Outcome|Maralixibat (LUM001) 1 mg|Participants received LUM001 tablet orally once daily at a dose of 1 mg during Week 2 of the treatment period.
53662|NCT02061540|E1|Reported Event|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
53663|NCT02061358|B10|Baseline|Total|Total of all reporting groups
53664|NCT02061358|B9|Baseline|Placebo|Placebo oral, single dose
53665|NCT02061358|B8|Baseline|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53666|NCT02061358|B7|Baseline|720 mg UV-4B|UV-4B 720 mg oral, single dose
53667|NCT02061358|B6|Baseline|360 mg UV-4B|UV-4B 360 mg oral, single dose
53668|NCT02061358|B5|Baseline|180 mg UV-4B|UV-4B 180 mg oral, single dose
53669|NCT02061358|B4|Baseline|90 mg UV-4B|UV-4B 90 mg oral, single dose
53670|NCT02061358|B3|Baseline|30 mg UV-4B|UV-4B 30 mg oral, single dose
53671|NCT02061358|B2|Baseline|10 mg UV-4B|UV-4B 10 mg oral, single dose
53672|NCT02061358|B1|Baseline|3 mg UV-4B|UV-4B 3 mg oral, single dose
53673|NCT02061358|P9|Participant Flow|Placebo|Placebo oral, single dose
53674|NCT02061358|P8|Participant Flow|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53675|NCT02061358|P7|Participant Flow|720 mg UV-4B|UV-4B 720 mg oral, single dose
53676|NCT02061358|P6|Participant Flow|360 mg UV-4B|UV-4B 360 mg oral, single dose
53677|NCT02061358|P5|Participant Flow|180 mg UV-4B|UV-4B 180 mg oral, single dose
53690|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53691|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53692|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53706|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53707|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53708|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53709|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53710|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53711|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53712|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53713|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53714|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53715|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53716|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53717|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53718|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53719|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53720|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53721|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53722|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53723|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53724|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53725|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53726|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53727|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53728|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53729|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53730|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53731|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53732|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53733|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53734|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53735|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53736|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53737|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53738|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53739|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53740|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53741|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53742|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53743|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53744|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53745|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53746|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53747|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53748|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53749|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53750|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53751|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53752|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53753|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53754|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53755|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53756|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53757|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53758|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53759|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53760|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53761|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53762|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
53763|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53764|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53765|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53766|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53767|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53768|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53769|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53772|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53773|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53774|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53775|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53776|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53777|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53778|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53779|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53780|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
53781|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53782|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53783|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53784|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53785|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53786|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53787|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53788|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53790|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53791|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53792|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53793|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53794|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53795|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53796|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53797|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53798|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
53799|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53800|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
53801|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
53802|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
53803|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
53804|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
53805|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
53806|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
53807|NCT02061358|E9|Reported Event|Placebo|Placebo oral, single dose
53808|NCT02061358|E8|Reported Event|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
53809|NCT02061358|E7|Reported Event|720 mg UV-4B|UV-4B 720 mg oral, single dose
53810|NCT02061358|E6|Reported Event|360 mg UV-4B|UV-4B 360 mg oral, single dose
53811|NCT02061358|E5|Reported Event|180 mg UV-4B|UV-4B 180 mg oral, single dose
53812|NCT02061358|E4|Reported Event|90 mg UV-4B|UV-4B 90 mg oral, single dose
53813|NCT02061358|E3|Reported Event|30 mg UV-4B|UV-4B 30 mg oral, single dose
53814|NCT02061358|E2|Reported Event|10 mg UV-4B|UV-4B 10 mg oral, single dose
53815|NCT02061358|E1|Reported Event|3 mg UV-4B|UV-4B 3 mg oral, single dose
53816|NCT02060838|B3|Baseline|Total|Total of all reporting groups
53817|NCT02060838|B2|Baseline|ANH Blood Collected in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
53818|NCT02060838|B1|Baseline|ANH Blood Collected in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
53819|NCT02060838|P2|Participant Flow|ANH Collected & Stored in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
53820|NCT02060838|P1|Participant Flow|ANH Collected & Stored in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
53821|NCT02060838|O2|Outcome|ANH Blood Collected in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
53822|NCT02060838|O1|Outcome|ANH Blood Collected in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
53823|NCT02060838|O2|Outcome|ANH Blood Collected in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
53866|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53867|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53824|NCT02060838|O1|Outcome|ANH Blood Collected in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
53825|NCT02060838|E2|Reported Event|ANH Blood Collected & Stored in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
53826|NCT02060838|E1|Reported Event|ANH Blood Collected & Stored in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
53827|NCT02060539|B1|Baseline|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53828|NCT02060539|P1|Participant Flow|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53878|NCT02060526|P1|Participant Flow|No HGT-1410|Participants received no treatment (HGT-1410).
53829|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53830|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53831|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53832|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53833|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53834|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53835|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53836|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53837|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53838|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53839|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53840|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53841|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53842|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53843|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53844|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53845|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53846|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53847|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53848|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53849|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53850|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53851|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53852|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53853|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53854|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53855|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53856|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53857|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53858|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53859|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53860|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53861|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53862|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53863|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53864|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53865|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53868|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53869|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53870|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53871|NCT02060539|E1|Reported Event|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A"
53872|NCT02060526|B4|Baseline|Total|Total of all reporting groups
53873|NCT02060526|B3|Baseline|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53874|NCT02060526|B2|Baseline|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53875|NCT02060526|B1|Baseline|No HGT-1410|Participants received no treatment (HGT-1410).
53876|NCT02060526|P3|Participant Flow|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally once every four weeks (Q4W) using surgically implanted IDDD or LP for 48 weeks.
53877|NCT02060526|P2|Participant Flow|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 milligram (mg) intrathecally once every two weeks (Q2W) using surgically implanted intrathecal drug delivery device (IDDD) or lumbar puncture (LP) for 48 weeks.
53879|NCT02060526|O2|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53880|NCT02060526|O1|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53881|NCT02060526|O2|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53882|NCT02060526|O1|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53883|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53884|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53885|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
53886|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53887|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53888|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
53889|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53890|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53891|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
53892|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53893|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53894|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
53895|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53896|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53897|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
53898|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53899|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53900|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
53901|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53902|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53903|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
53904|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53905|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53906|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
53907|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53908|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53909|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
53910|NCT02060526|E3|Reported Event|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
53911|NCT02060526|E2|Reported Event|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
53912|NCT02060526|E1|Reported Event|No HGT-1410|Participants received no treatment (HGT-1410).
53913|NCT02059993|B3|Baseline|Total|Total of all reporting groups
53914|NCT02059993|B2|Baseline|Control|The control group received the standardized antihypertensive medications but without receiving CPAP machine.
53997|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
53998|NCT02059187|E2|Reported Event|Lantus™|Lantus™ administered subcutaneously once daily.
53915|NCT02059993|B1|Baseline|Continuous Positive Airway Pressure(CPAP) Group|The CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.
53916|NCT02059993|P2|Participant Flow|Control|The controls only received the cardiovascular drugs based on the guidelines but without continuous positive airway pressure machine.
53917|NCT02059993|P1|Participant Flow|Continuous Positive Airway Pressure(CPAP) Group|The continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure and the the cardiovascular drugs based on the guidelines.
53918|NCT02059993|O2|Outcome|Control|The patients who use standardized drugs without CPAP machine.
53919|NCT02059993|O1|Outcome|Continuous Positive Airway Pressure(CPAP) Group|The subjects who received CPAP treatment and standardized medicine.
53920|NCT02059993|E2|Reported Event|Control|The control subjects received standardised anti-hypertension medications according to the current guildline.
53921|NCT02059993|E1|Reported Event|Continuous Positive Airway Pressure(CPAP) Group|The CPAP group received fixed-level CPAP titration using an automated pressure setting device for 1 night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.
88738|NCT01848834|B6|Baseline|Total|Total of all reporting groups
53922|NCT02059928|B1|Baseline|Intraosseous Device Placement|"Intraosseous device
Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients"
53923|NCT02059928|P1|Participant Flow|Intraosseous Device Placement|"Intraosseous device
Intraosseous Device pressure measurement"
53924|NCT02059928|O1|Outcome|Intraosseous Device Placement|Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients
53925|NCT02059928|E1|Reported Event|Intraosseous Device Placement|Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients
53926|NCT02059902|B3|Baseline|Total|Total of all reporting groups
53927|NCT02059902|B2|Baseline|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)
Lidocaine: Lidocaine infusion runs for a total of 24 hours"
53928|NCT02059902|B1|Baseline|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)
Placebo: Normal saline runs for a total of 24 hours"
53929|NCT02059902|P2|Participant Flow|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)
Lidocaine: Lidocaine infusion runs for a total of 24 hours"
53930|NCT02059902|P1|Participant Flow|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)
Placebo: Normal saline runs for a total of 24 hours"
53931|NCT02059902|O2|Outcome|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)
Lidocaine: Lidocaine infusion runs for a total of 24 hours"
53932|NCT02059902|O1|Outcome|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)
Placebo: Normal saline runs for a total of 24 hours"
53933|NCT02059902|E2|Reported Event|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)
Lidocaine: Lidocaine infusion runs for a total of 24 hours"
53934|NCT02059902|E1|Reported Event|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)
Placebo: Normal saline runs for a total of 24 hours"
53935|NCT02059642|B3|Baseline|Total|Total of all reporting groups
53936|NCT02059642|B2|Baseline|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily
MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
53937|NCT02059642|B1|Baseline|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily
placebo: Placebo 1400 mg administered orally once daily"
53938|NCT02059642|P2|Participant Flow|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily
MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
53939|NCT02059642|P1|Participant Flow|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily
placebo: Placebo 1400 mg administered orally once daily"
53940|NCT02059642|O2|Outcome|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily
MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
53941|NCT02059642|O1|Outcome|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily
placebo: Placebo 1400 mg administered orally once daily"
53942|NCT02059642|O2|Outcome|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily
MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
53943|NCT02059642|O1|Outcome|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily
placebo: Placebo 1400 mg administered orally once daily"
53944|NCT02059642|E2|Reported Event|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily
MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
53945|NCT02059642|E1|Reported Event|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily
placebo: Placebo 1400 mg administered orally once daily"
53946|NCT02059291|B7|Baseline|Total|Total of all reporting groups
53947|NCT02059291|B6|Baseline|TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
53948|NCT02059291|B5|Baseline|TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
53949|NCT02059291|B4|Baseline|HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
54005|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54006|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
56918|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
53950|NCT02059291|B3|Baseline|HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
53951|NCT02059291|B2|Baseline|crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.
150mg, participants were uptitrated to open-label canakinumab 300 mg."
53952|NCT02059291|B1|Baseline|crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
53953|NCT02059291|P6|Participant Flow|TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
53954|NCT02059291|P5|Participant Flow|TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
53955|NCT02059291|P4|Participant Flow|HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
53956|NCT02059291|P3|Participant Flow|HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
53957|NCT02059291|P2|Participant Flow|crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.
150mg, participants were uptitrated to open-label canakinumab 300 mg."
53958|NCT02059291|P1|Participant Flow|crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
53959|NCT02059291|O6|Outcome|TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
53999|NCT02059187|E1|Reported Event|MK-1293|MK-1293 administered subcutaneously once daily.
54000|NCT02059174|B1|Baseline|All Participants|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54143|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
53960|NCT02059291|O5|Outcome|TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
53961|NCT02059291|O4|Outcome|HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
53962|NCT02059291|O3|Outcome|HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
53963|NCT02059291|O2|Outcome|crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.
150mg, participants were uptitrated to open-label canakinumab 300 mg."
53964|NCT02059291|O1|Outcome|crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
53965|NCT02059291|E6|Reported Event|crFMF Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape prior to day 29, received 1 dose of canakinumab 150 mg and 1 dose of placebo q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
53966|NCT02059291|E5|Reported Event|crFMF 150 mg + crFMF Placebo Switched to 150 mg|crFMF 150 mg plus crFMF placebo non responders switched to 150 mg
53967|NCT02059291|E4|Reported Event|HIDS Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape prior to day 29, received 1 dose of canakinumab 150 mg and 1 dose of placebo q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
53968|NCT02059291|E3|Reported Event|HIDS/MKD 150 mg + HIDS/MKD Placebo Switched to 150 mg|HIDS/MKD 150 mg plus HIDS/MKD non responders switched to 150 mg
53969|NCT02059291|E2|Reported Event|TRAPS Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape prior to day 29, received 1 dose of canakinumab 150 mg and 1 dose of placebo q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
53970|NCT02059291|E1|Reported Event|TRAPS 150 mg + TRAPS Placebo Switched to 150mg|TRAPS 150mg plus TRAPS placebo non responders switched to 150 mg
53971|NCT02059187|B3|Baseline|Total|Total of all reporting groups
53972|NCT02059187|B2|Baseline|Lantus™|Lantus™ administered subcutaneously once daily.
53973|NCT02059187|B1|Baseline|MK-1293|MK-1293 administered subcutaneously once daily.
53974|NCT02059187|P2|Participant Flow|Lantus™|Lantus™ administered subcutaneously once daily.
53975|NCT02059187|P1|Participant Flow|MK-1293|MK-1293 administered subcutaneously once daily.
53976|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
53977|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
53978|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
53979|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
53980|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
53981|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
53982|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
53983|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
53984|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
53985|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
53986|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
53987|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
53988|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
53989|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
53990|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
53991|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
53992|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
53993|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
53994|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
53995|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
53996|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
97564|NCT01797328|B3|Baseline|Total|Total of all reporting groups
54001|NCT02059174|P2|Participant Flow|EU-Lantus™ / MK-1293 / EU-Lantus™ / MK-1293|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54002|NCT02059174|P1|Participant Flow|MK-1293 / EU-Lantus™ / MK-1293 / EU-Lantus™|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54003|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54004|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
56919|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
54007|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54008|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54009|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54010|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54011|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54012|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54013|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54014|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54015|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54016|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54017|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54018|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54019|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54020|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
54021|NCT02059174|E2|Reported Event|EU-Lantus™ 0.4 Units.kg SC|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between treatment periods
54022|NCT02059174|E1|Reported Event|MK-1293 0.4 Units/kg SC|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between treatment periods
54023|NCT02059161|B3|Baseline|Total|Total of all reporting groups
54024|NCT02059161|B2|Baseline|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54025|NCT02059161|B1|Baseline|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54026|NCT02059161|P2|Participant Flow|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54027|NCT02059161|P1|Participant Flow|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54028|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54029|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54030|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54142|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
54031|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54032|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54033|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54034|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54035|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
56920|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
54036|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54037|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54038|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54039|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54040|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54041|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54042|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54043|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54044|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54045|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54046|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54047|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54048|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54049|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54050|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54051|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54052|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54053|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54054|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54055|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54056|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54560|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
54057|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54058|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54059|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54060|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54061|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54062|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54063|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54064|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54065|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54066|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54067|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54068|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54069|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54070|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54071|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54072|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54073|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54074|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54075|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54076|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54077|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54078|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54079|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54080|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54081|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54082|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54561|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
54083|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54084|NCT02059161|E2|Reported Event|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54085|NCT02059161|E1|Reported Event|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
54086|NCT02059135|B3|Baseline|Total|Total of all reporting groups
54087|NCT02059135|B2|Baseline|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.
Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
54149|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54088|NCT02059135|B1|Baseline|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days
Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
54089|NCT02059135|P2|Participant Flow|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.
Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
54090|NCT02059135|P1|Participant Flow|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days
Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
54091|NCT02059135|O2|Outcome|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.
Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
54092|NCT02059135|O1|Outcome|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days
Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
54093|NCT02059135|O2|Outcome|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.
Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
54094|NCT02059135|O1|Outcome|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days
Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
54095|NCT02059135|O2|Outcome|Normal Saline 0.9%|"Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.
Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%"
54096|NCT02059135|O1|Outcome|Recombinant Human Antithrombin (ATryn)|"ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days
Recombinant human antithrombin (ATryn): Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
54097|NCT02059135|E4|Reported Event|Neonatal Safety Population: Placebo|Neonates born to mothers treated with placebo (Normal Saline 0.9%)
54098|NCT02059135|E3|Reported Event|Neonatal Safety Population: ATryn|Neonates born to mothers treated with Recombinant Human Antithrombin (ATryn)
54099|NCT02059135|E2|Reported Event|Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%)|Subjects treated with Placebo; Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.
54100|NCT02059135|E1|Reported Event|Maternal/Fetal Safety Population: ATryn|"Subjects treated with Recombinant human antithrombin (ATryn):
ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days"
54101|NCT02059070|B3|Baseline|Total|Total of all reporting groups
54102|NCT02059070|B2|Baseline|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54103|NCT02059070|B1|Baseline|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54104|NCT02059070|P2|Participant Flow|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54105|NCT02059070|P1|Participant Flow|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54106|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54107|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54562|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
54108|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54109|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54110|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54111|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
56921|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
54112|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54113|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54114|NCT02059070|E2|Reported Event|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54115|NCT02059070|E1|Reported Event|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
54116|NCT02058992|B1|Baseline|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
54117|NCT02058992|P1|Participant Flow|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
54118|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
54119|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
54120|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
54121|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
54122|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
54123|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
54124|NCT02058992|E1|Reported Event|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
54125|NCT02058628|B3|Baseline|Total|Total of all reporting groups
54126|NCT02058628|B2|Baseline|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
54127|NCT02058628|B1|Baseline|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54128|NCT02058628|P2|Participant Flow|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule.
54129|NCT02058628|P1|Participant Flow|DUAC®|Participants received DUAC® (1.2 percent clindamycin + 3 percent of benzoyl peroxide [BPO]) once daily in the evening for 12 weeks as per the randomization schedule.
54130|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
54131|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54132|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
54133|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54134|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
54135|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54136|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization.
54137|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54138|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
54139|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54140|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
54141|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54273|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54144|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule
54145|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54146|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
54147|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54148|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule
54150|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
54151|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of benzoyl peroxide (BPO)) once daily in the evening for 12 weeks as per the randomization schedule
54152|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
54153|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54154|NCT02058628|O2|Outcome|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
54155|NCT02058628|O1|Outcome|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
54156|NCT02058628|E2|Reported Event|SKINOREN®|Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule
54157|NCT02058628|E1|Reported Event|DUAC®|Participants received DUAC® (1.2 percent clindamycin and 3 percent of benzoyl peroxide (BPO)) once daily in the evening for 12 weeks as per the randomization schedule
54158|NCT02058563|B3|Baseline|Total|Total of all reporting groups
54159|NCT02058563|B2|Baseline|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54160|NCT02058563|B1|Baseline|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54161|NCT02058563|P2|Participant Flow|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II ) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54162|NCT02058563|P1|Participant Flow|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54163|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54164|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54165|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54166|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54167|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54168|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54169|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54170|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54171|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54172|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54173|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54174|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54175|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54176|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54177|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54178|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54179|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54180|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54181|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54182|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54183|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54184|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54185|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54186|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54187|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54188|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54189|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54190|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54191|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54192|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54193|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54194|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
54195|NCT02058563|E2|Reported Event|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
54196|NCT02058563|E1|Reported Event|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
56922|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
54197|NCT02058537|B1|Baseline|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.
Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
54198|NCT02058537|P1|Participant Flow|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.
Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
54199|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.
Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
54200|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.
Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
54201|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.
Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
54202|NCT02058537|E1|Reported Event|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.
Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
54203|NCT02058498|B1|Baseline|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.
Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
54204|NCT02058498|P1|Participant Flow|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.
Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
54205|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.
Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
54206|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.
Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
54207|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.
Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
54208|NCT02058498|E1|Reported Event|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.
Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
54209|NCT02058290|B3|Baseline|Total|Total of all reporting groups
54210|NCT02058290|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed."
54211|NCT02058290|B1|Baseline|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
54212|NCT02058290|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed."
54213|NCT02058290|P1|Participant Flow|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
54234|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54214|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed."
54215|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
54216|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed."
54217|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
54218|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed."
54219|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
54220|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed."
54221|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
54222|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed."
54223|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
54224|NCT02058290|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed."
54225|NCT02058290|E1|Reported Event|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
54226|NCT02058160|B3|Baseline|Total|Total of all reporting groups
54227|NCT02058160|B2|Baseline|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54550|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
54228|NCT02058160|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54229|NCT02058160|P2|Participant Flow|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54230|NCT02058160|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
54231|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54232|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54233|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54235|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54236|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54237|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54238|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54239|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54240|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54241|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54242|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54243|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54244|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54245|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54246|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54247|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54248|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54249|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54250|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54251|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54252|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54253|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54254|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54255|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54256|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54257|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54258|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54259|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54260|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54261|NCT02058160|E2|Reported Event|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 210 days).
54262|NCT02058160|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
54263|NCT02058147|B4|Baseline|Total|Total of all reporting groups
54264|NCT02058147|B3|Baseline|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54265|NCT02058147|B2|Baseline|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54266|NCT02058147|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54267|NCT02058147|P3|Participant Flow|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54268|NCT02058147|P2|Participant Flow|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54269|NCT02058147|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
54270|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54271|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54272|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54274|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54275|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54276|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54277|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54278|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54279|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54280|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54281|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54282|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54283|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54284|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54285|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54286|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54287|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54288|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54289|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54290|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54291|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54292|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54293|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54294|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54295|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54296|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54297|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54298|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54299|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54300|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54301|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54302|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54303|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54304|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54305|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54306|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54307|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54308|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54309|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54310|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54311|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
54312|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54313|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
54314|NCT02058147|E3|Reported Event|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose) median exposure: 211 days).
54315|NCT02058147|E2|Reported Event|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
54316|NCT02058147|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
54317|NCT02058069|B1|Baseline|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
54318|NCT02058069|P1|Participant Flow|Robotic Assisted Total Knee Arthroplasty|"Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
Participants throughout this posting is equivalent to the number of knees."
54551|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
54319|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
54320|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
54321|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
54322|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
54323|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
54324|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
54359|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54325|NCT02058069|E1|Reported Event|Robotic Assisted Total Knee Arthroplasty|"Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
Note regarding serious AEs:
Adhesions and arthrofibrosis are surgical complications that can result from knee surgery and present as stiffness and restriction of ROM. Reasons for stiffness and restriction of ROM after TKA are multifactorial and may be influenced by factors such as the patient’s overall health, motivation, and compliance to their rehabilitation regimen. The Principal Investigator and study Investigators stated these adverse events are not related to the use of the Investigational Device."
54326|NCT02057835|B11|Baseline|Total|Total of all reporting groups
54327|NCT02057835|B10|Baseline|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54328|NCT02057835|B9|Baseline|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54329|NCT02057835|B8|Baseline|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54330|NCT02057835|B7|Baseline|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54331|NCT02057835|B6|Baseline|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
54332|NCT02057835|B5|Baseline|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54333|NCT02057835|B4|Baseline|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54334|NCT02057835|B3|Baseline|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54335|NCT02057835|B2|Baseline|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54336|NCT02057835|B1|Baseline|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
54337|NCT02057835|P10|Participant Flow|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54338|NCT02057835|P9|Participant Flow|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54339|NCT02057835|P8|Participant Flow|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54340|NCT02057835|P7|Participant Flow|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54341|NCT02057835|P6|Participant Flow|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
54342|NCT02057835|P5|Participant Flow|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54343|NCT02057835|P4|Participant Flow|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54344|NCT02057835|P3|Participant Flow|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54345|NCT02057835|P2|Participant Flow|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54346|NCT02057835|P1|Participant Flow|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
54347|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54348|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54349|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54350|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54351|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54352|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54353|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54552|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
54354|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54355|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54356|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54357|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54358|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54360|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54361|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54362|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54363|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54364|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54365|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54366|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54367|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54368|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54369|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54370|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54371|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54372|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54373|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54374|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54375|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54376|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54377|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54378|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54379|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54380|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54381|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54382|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54383|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54384|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54385|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54386|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54387|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54388|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54389|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54390|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54391|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54392|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54393|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54394|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54395|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54396|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54397|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54398|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54399|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54400|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54401|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54402|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54403|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54404|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54405|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54406|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54407|NCT02057835|O10|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54408|NCT02057835|O9|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54409|NCT02057835|O8|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54410|NCT02057835|O7|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54411|NCT02057835|O6|Outcome|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
54412|NCT02057835|O5|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54413|NCT02057835|O4|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54414|NCT02057835|O3|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54415|NCT02057835|O2|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54416|NCT02057835|O1|Outcome|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
54417|NCT02057835|E5|Reported Event|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
54418|NCT02057835|E4|Reported Event|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
54419|NCT02057835|E3|Reported Event|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
54420|NCT02057835|E2|Reported Event|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
54421|NCT02057835|E1|Reported Event|Placebo|Participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
54422|NCT02057549|B3|Baseline|Total|Total of all reporting groups
54423|NCT02057549|B2|Baseline|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54424|NCT02057549|B1|Baseline|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54425|NCT02057549|P2|Participant Flow|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54553|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
54426|NCT02057549|P1|Participant Flow|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54427|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54445|NCT02057406|B4|Baseline|Total|Total of all reporting groups
54446|NCT02057406|B3|Baseline|Placebo|"Matched placebo corn oil capsules
Placebo"
54447|NCT02057406|B2|Baseline|High EPA|"Almost pure EPA 2 grams
High EPA"
89784|NCT01843374|P2|Participant Flow|TREMELIMUMAB|TREMELIMUMAB 10 mg/kg
54428|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54429|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54430|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54431|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54432|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54433|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54434|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54435|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54436|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54437|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54438|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54439|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54440|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54441|NCT02057549|O2|Outcome|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54442|NCT02057549|O1|Outcome|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54554|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
54443|NCT02057549|E2|Reported Event|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54444|NCT02057549|E1|Reported Event|Haloperidol Plus Conventional Therapy|Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
54448|NCT02057406|B1|Baseline|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
54449|NCT02057406|P3|Participant Flow|Placebo|"Matched placebo corn oil capsules
Placebo"
54450|NCT02057406|P2|Participant Flow|High EPA|"Almost pure EPA 2 grams
High EPA"
54451|NCT02057406|P1|Participant Flow|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid (DHA) fish oil 2 grams"
54452|NCT02057406|O3|Outcome|Placebo|"Matched placebo corn oil capsules
Placebo"
54453|NCT02057406|O2|Outcome|High EPA|"Almost pure EPA 2 grams
High EPA"
54454|NCT02057406|O1|Outcome|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
54455|NCT02057406|O3|Outcome|Placebo|"Matched placebo corn oil capsules
Placebo"
54456|NCT02057406|O2|Outcome|High EPA|"Almost pure EPA 2 grams
High EPA"
54457|NCT02057406|O1|Outcome|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
54458|NCT02057406|E3|Reported Event|Placebo|"Matched placebo corn oil capsules
Placebo"
54459|NCT02057406|E2|Reported Event|High EPA|"Almost pure EPA 2 grams
High EPA"
54460|NCT02057406|E1|Reported Event|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
54461|NCT02057393|B1|Baseline|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.
Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.
Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.
Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
54462|NCT02057393|P1|Participant Flow|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.
Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.
Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.
Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
54463|NCT02057393|O1|Outcome|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.
Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.
Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.
Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
54464|NCT02057393|E1|Reported Event|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.
Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.
Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.
Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
54465|NCT02057276|B3|Baseline|Total|Total of all reporting groups
54466|NCT02057276|B2|Baseline|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Sham Repetitive Transcranial Magnetic Stimulation
Occupational Therapy"
54467|NCT02057276|B1|Baseline|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
Occupational Therapy"
54468|NCT02057276|P2|Participant Flow|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Sham Repetitive Transcranial Magnetic Stimulation
Occupational Therapy"
54469|NCT02057276|P1|Participant Flow|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
Occupational Therapy"
54470|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Sham Repetitive Transcranial Magnetic Stimulation
Occupational Therapy"
54471|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
Occupational Therapy"
54472|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Sham Repetitive Transcranial Magnetic Stimulation
Occupational Therapy"
54601|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
54473|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
Occupational Therapy"
54474|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Sham Repetitive Transcranial Magnetic Stimulation
Occupational Therapy"
54475|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
Occupational Therapy"
54476|NCT02057276|E2|Reported Event|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Sham Repetitive Transcranial Magnetic Stimulation
Occupational Therapy"
54477|NCT02057276|E1|Reported Event|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
Occupational Therapy"
54478|NCT02057250|B5|Baseline|Total|Total of all reporting groups
54479|NCT02057250|B4|Baseline|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
54480|NCT02057250|B3|Baseline|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
54481|NCT02057250|B2|Baseline|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
54482|NCT02057250|B1|Baseline|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
54483|NCT02057250|P5|Participant Flow|Sarilumab 150 mg by PFS (Extension Phase)|Participants who completed 12 week AID assessment phase received Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
54484|NCT02057250|P4|Participant Flow|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
54485|NCT02057250|P3|Participant Flow|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
54486|NCT02057250|P2|Participant Flow|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
54487|NCT02057250|P1|Participant Flow|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) for 12 weeks.
54488|NCT02057250|O4|Outcome|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
54489|NCT02057250|O3|Outcome|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
54490|NCT02057250|O2|Outcome|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
54491|NCT02057250|O1|Outcome|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
54492|NCT02057250|O2|Outcome|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
54493|NCT02057250|O1|Outcome|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
54494|NCT02057250|E5|Reported Event|Sarilumab 150 mg by PFS (Extension Phase)|Participants who completed 12 week AID assessment phase received Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
54495|NCT02057250|E4|Reported Event|Sarilumab 200 mg by PFS (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
54496|NCT02057250|E3|Reported Event|Sarilumab 200 mg by AID (AID Assessment Phase)|Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
54497|NCT02057250|E2|Reported Event|Sarilumab 150 mg by PFS (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.
54498|NCT02057250|E1|Reported Event|Sarilumab 150 mg by AID (AID Assessment Phase)|Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.
54499|NCT02057237|B1|Baseline|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.
Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
54555|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
54556|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
54557|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
54500|NCT02057237|P1|Participant Flow|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.
Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
54501|NCT02057237|O1|Outcome|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.
Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
54502|NCT02057237|O1|Outcome|Single Arm|"Mitotane will be administered on an outpatient or inpatient basis.
Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
54503|NCT02057237|E1|Reported Event|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.
Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
54504|NCT02056834|B1|Baseline|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54505|NCT02056834|P1|Participant Flow|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54506|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54507|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54508|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54509|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54510|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54511|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54512|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54513|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54514|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54515|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54516|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54517|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54518|NCT02056834|O1|Outcome|chronOS Inject|"Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures"
54519|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54520|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54521|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
54522|NCT02056834|E1|Reported Event|chronOS Inject|"Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures"
54523|NCT02056392|B7|Baseline|Total|Total of all reporting groups
54524|NCT02056392|B6|Baseline|Selumetinib/Selumetinib Placebo/Moxifloxacin|
54525|NCT02056392|B5|Baseline|Selumetinib Placebo/Selumetinib/Moxifloxacin|
54526|NCT02056392|B4|Baseline|Selumetinib Placebo/Moxifloxacin/Selumetinib|
54527|NCT02056392|B3|Baseline|Moxifloxacin/Selumetinib Placebo/Selumetinib|
54528|NCT02056392|B2|Baseline|Moxifloxacin/Selumetinib/Selumetinib Placebo|
54529|NCT02056392|B1|Baseline|Selumetinib/Moxifloxacin/Selumetinib Placebo|
54530|NCT02056392|P6|Participant Flow|Selumetinib/Selumetinib Placebo/Moxifloxacin|
54531|NCT02056392|P5|Participant Flow|Selumetinib Placebo/Selumetinib/Moxifloxacin|
54532|NCT02056392|P4|Participant Flow|Selumetinib Placebo/Moxifloxacin/Selumetinib|
54533|NCT02056392|P3|Participant Flow|Moxifloxacin/Selumetinib Placebo/Selumetinib|
54534|NCT02056392|P2|Participant Flow|Moxifloxacin/Selumetinib/Selumetinib Placebo|
54535|NCT02056392|P1|Participant Flow|Selumetinib/Moxifloxacin/Selumetinib Placebo|
54536|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
54537|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
54538|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
54539|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
54540|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
54541|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
54542|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
54543|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
54544|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
54545|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
54546|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
54547|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
54548|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
54549|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
54563|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
54564|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
54565|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
54566|NCT02056392|E3|Reported Event|Placebo|Selumetinib placebo (3 capsules)
54567|NCT02056392|E2|Reported Event|Moxifloxacin|Moxiflxacin 400 mg (open label)
54568|NCT02056392|E1|Reported Event|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
54569|NCT02055430|B3|Baseline|Total|Total of all reporting groups
54602|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
54570|NCT02055430|B2|Baseline|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.
bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.
Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
54571|NCT02055430|B1|Baseline|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.
percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.
Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
54572|NCT02055430|P2|Participant Flow|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.
bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.
Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
54573|NCT02055430|P1|Participant Flow|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.
percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.
Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
54574|NCT02055430|O2|Outcome|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.
bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.
Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
54575|NCT02055430|O1|Outcome|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.
percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.
Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
54576|NCT02055430|E2|Reported Event|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.
bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.
Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
54577|NCT02055430|E1|Reported Event|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.
percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.
Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
54578|NCT02055404|B1|Baseline|Overall Study|Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
54579|NCT02055404|P1|Participant Flow|Overall Study|Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
54580|NCT02055404|O9|Outcome|Control|Etafilcon A toric contact lens
54581|NCT02055404|O8|Outcome|S8 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
54582|NCT02055404|O7|Outcome|S7 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
54583|NCT02055404|O6|Outcome|S6 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
54584|NCT02055404|O5|Outcome|S5 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
54585|NCT02055404|O4|Outcome|S4 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
54586|NCT02055404|O3|Outcome|S3 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
54587|NCT02055404|O2|Outcome|S2 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
54588|NCT02055404|O1|Outcome|S1 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
54589|NCT02055404|E2|Reported Event|Etafilcon A|Etafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration
54590|NCT02055404|E1|Reported Event|Delefilcon A|Delefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration.
54591|NCT02055352|B3|Baseline|Total|Total of all reporting groups
54592|NCT02055352|B2|Baseline|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
54593|NCT02055352|B1|Baseline|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
54594|NCT02055352|P2|Participant Flow|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
54595|NCT02055352|P1|Participant Flow|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
54596|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
54597|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
54598|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
54599|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
54600|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
55126|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
54603|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
54604|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
54605|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
54606|NCT02055352|E2|Reported Event|Fluticasone / Salmeterol (B)|Fluticasone / Salmeterol (B)
54607|NCT02055352|E1|Reported Event|Budesonide / Indacaterol (A)|Budesonide / Indacaterol (A)
54608|NCT02054910|B3|Baseline|Total|Total of all reporting groups
54609|NCT02054910|B2|Baseline|Sham|"A celiac plexus block will not be administered for pain management
Sham"
54610|NCT02054910|B1|Baseline|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS
Celiac Plexus Block"
54611|NCT02054910|P2|Participant Flow|Sham|"A celiac plexus block will not be administered for pain management
Sham"
54612|NCT02054910|P1|Participant Flow|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS
Celiac Plexus Block"
54613|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
54614|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
54615|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
54616|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
54617|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
54618|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
54619|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
54620|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
54621|NCT02054910|O2|Outcome|Sham|"A celiac plexus block will not be administered for pain management
Sham"
54622|NCT02054910|O1|Outcome|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS
Celiac Plexus Block"
54623|NCT02054910|O2|Outcome|Sham|"A celiac plexus block will not be administered for pain management
Sham"
54624|NCT02054910|O1|Outcome|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS
Celiac Plexus Block"
54625|NCT02054910|E2|Reported Event|Sham|"A celiac plexus block will not be administered for pain management
Sham"
54626|NCT02054910|E1|Reported Event|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS
Celiac Plexus Block"
54627|NCT02054754|B3|Baseline|Total|Total of all reporting groups
54628|NCT02054754|B2|Baseline|Placebo|"Single oral dose of matching placebo
Placebo"
54629|NCT02054754|B1|Baseline|Dexanabinol|"Single oral dose of dexanabinol
Dexanabinol: Oral formulation of dexanabinol"
54630|NCT02054754|P6|Participant Flow|Placebo|"Single oral dose of matching placebo
Placebo"
54631|NCT02054754|P5|Participant Flow|Dexanabinol Dose Level 5|"Single oral dose of dexanabinol at Dose level 5
Dexanabinol: Oral formulation of dexanabinol"
54632|NCT02054754|P4|Participant Flow|Dexanabinol Dose Level 4|"Single oral dose of dexanabinol at Dose level 4
Dexanabinol: Oral formulation of dexanabinol"
54633|NCT02054754|P3|Participant Flow|Dexanabinol Dose Level 3|"Single oral dose of dexanabinol at Dose level 3
Dexanabinol: Oral formulation of dexanabinol"
54634|NCT02054754|P2|Participant Flow|Dexanabinol Dose Level 2|"Single oral dose of dexanabinol at Dose level 2
Dexanabinol: Oral formulation of dexanabinol"
54635|NCT02054754|P1|Participant Flow|Dexanabinol Dose Level 1|"Single oral dose of dexanabinol at Dose Level 1
Dexanabinol: Oral formulation of dexanabinol"
54636|NCT02054754|O5|Outcome|Dose Level 5|
54637|NCT02054754|O4|Outcome|Dose Level 4|
54638|NCT02054754|O3|Outcome|Dose Level 3|
54639|NCT02054754|O2|Outcome|Dose Level 2|
54640|NCT02054754|O1|Outcome|Dexanabinol Dose Level 1|
54641|NCT02054754|O2|Outcome|Placebo|"Single oral dose of matching placebo
Placebo"
54642|NCT02054754|O1|Outcome|Dexanabinol|"Single oral dose of dexanabinol
Dexanabinol: Oral formulation of dexanabinol"
54643|NCT02054754|E6|Reported Event|Placebo|"Single oral dose of matching placebo
Placebo"
54644|NCT02054754|E5|Reported Event|Dexanabinol Dose Level 5|"Single oral dose of dexanabinol
Dexanabinol: Oral formulation of dexanabinol"
54645|NCT02054754|E4|Reported Event|Dexanabinol Dose Level 4|"Single oral dose of dexanabinol
Dexanabinol: Oral formulation of dexanabinol"
54646|NCT02054754|E3|Reported Event|Dexanabinol Dose Level 3|"Single oral dose of dexanabinol
Dexanabinol: Oral formuulation of dexanabinol"
54647|NCT02054754|E2|Reported Event|Dexanabinol Dose Level 2|"Single oral dose of dexanabinol
Dexanabinol: Oral formulation of dexanabinol"
54648|NCT02054754|E1|Reported Event|Dexanabinol Dose Level 1|"Single oral dose of dexanabinol
Dexanabinol: Oral formulation of dexanabinol"
54649|NCT02054715|B3|Baseline|Total|Total of all reporting groups
54650|NCT02054715|B2|Baseline|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
multimedia psychoeducational intervention: multimedia psychoeducational intervention"
97933|NCT01792830|B8|Baseline|Total|Total of all reporting groups
54651|NCT02054715|B1|Baseline|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
print educational intervention: print educational intervention"
54652|NCT02054715|P2|Participant Flow|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
multimedia psychoeducational intervention: multimedia psychoeducational intervention"
54653|NCT02054715|P1|Participant Flow|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
print educational intervention: print educational intervention"
54654|NCT02054715|O2|Outcome|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
multimedia psychoeducational intervention: multimedia psychoeducational intervention"
54655|NCT02054715|O1|Outcome|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
print educational intervention: print educational intervention"
54656|NCT02054715|O2|Outcome|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
multimedia psychoeducational intervention: multimedia psychoeducational intervention"
54657|NCT02054715|O1|Outcome|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
print educational intervention: print educational intervention"
54658|NCT02054715|O2|Outcome|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
multimedia psychoeducational intervention: multimedia psychoeducational intervention"
54659|NCT02054715|O1|Outcome|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
print educational intervention: print educational intervention"
54660|NCT02054715|O2|Outcome|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
multimedia psychoeducational intervention: multimedia psychoeducational intervention"
54661|NCT02054715|O1|Outcome|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
print educational intervention: print educational intervention"
54662|NCT02054715|E2|Reported Event|Arm II (Multimedia Psychoeducational)|"Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
multimedia psychoeducational intervention: multimedia psychoeducational intervention"
54663|NCT02054715|E1|Reported Event|Arm I (Print Educational)|"Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
print educational intervention: print educational intervention"
54664|NCT02054702|B3|Baseline|Total|Total of all reporting groups
54665|NCT02054702|B2|Baseline|Arpiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54666|NCT02054702|B1|Baseline|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54667|NCT02054702|P2|Participant Flow|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54668|NCT02054702|P1|Participant Flow|Brexpiprazole|Participants were administered brexpiprazole tablets orally, once daily (QD) starting dose at 1 milligram per day (mg/day) for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54669|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54670|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54671|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
98070|NCT01791725|O3|Outcome|Placebo|"Placebo BID
Placebo"
54672|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54673|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54674|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54675|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54676|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54677|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54678|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54679|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54680|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54681|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54682|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54683|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54684|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54685|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54686|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54687|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54688|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54689|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54690|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54691|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54692|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54693|NCT02054702|E2|Reported Event|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
54694|NCT02054702|E1|Reported Event|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
54695|NCT02054572|B1|Baseline|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54696|NCT02054572|P1|Participant Flow|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54697|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54698|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54699|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54700|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54863|NCT02052895|O2|Outcome|Procalcitonin|ROC-AUC of procalcitonin for discriminating between Sepsis and SIRS
54701|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54702|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54703|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
55127|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
54704|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54705|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54706|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54707|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54708|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54709|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54710|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54711|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54712|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54713|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54714|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54715|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54716|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
54717|NCT02054572|E1|Reported Event|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by IV bolus at the end of hemodialysis on day 1.
54718|NCT02054481|B5|Baseline|Total|Total of all reporting groups
54719|NCT02054481|B4|Baseline|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
54720|NCT02054481|B3|Baseline|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
54721|NCT02054481|B2|Baseline|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
54722|NCT02054481|B1|Baseline|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
54723|NCT02054481|P4|Participant Flow|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
54724|NCT02054481|P3|Participant Flow|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
54725|NCT02054481|P2|Participant Flow|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
54726|NCT02054481|P1|Participant Flow|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
54727|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
54728|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
54729|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
54730|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
54731|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
98071|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD
ELND005"
54732|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
54733|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
55128|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
54734|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
54735|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
54736|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
54737|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
54738|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
54739|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
54740|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
54741|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
54742|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
54743|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
54744|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
54745|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
54746|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
54747|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
54748|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
54749|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
54750|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
54751|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
54752|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
54753|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
54754|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
54755|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
54756|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
54757|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
54758|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
54759|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
54760|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
54761|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
54869|NCT02052752|B3|Baseline|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54762|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
54763|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
54764|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
54765|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
54766|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
54767|NCT02054481|E4|Reported Event|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
54768|NCT02054481|E3|Reported Event|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
54769|NCT02054481|E2|Reported Event|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
54770|NCT02054481|E1|Reported Event|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
54771|NCT02054325|B3|Baseline|Total|Total of all reporting groups
54772|NCT02054325|B2|Baseline|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.
Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
54773|NCT02054325|B1|Baseline|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.
Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
54774|NCT02054325|P2|Participant Flow|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.
Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
54775|NCT02054325|P1|Participant Flow|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.
Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
54776|NCT02054325|O2|Outcome|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.
Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
54777|NCT02054325|O1|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.
Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
54778|NCT02054325|O2|Outcome|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.
Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
54779|NCT02054325|O1|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.
Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
54780|NCT02054325|E2|Reported Event|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.
Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
54781|NCT02054325|E1|Reported Event|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.
Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
54782|NCT02053610|B3|Baseline|Total|Total of all reporting groups
54783|NCT02053610|B2|Baseline|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54784|NCT02053610|B1|Baseline|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54785|NCT02053610|P2|Participant Flow|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54786|NCT02053610|P1|Participant Flow|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54787|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54788|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54789|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54790|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54791|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54792|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54793|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54794|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54795|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54796|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54797|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54798|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54799|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54800|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54801|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54802|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54803|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54804|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54805|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54806|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54807|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54808|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54809|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54810|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54811|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54812|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54813|NCT02053610|E2|Reported Event|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
54814|NCT02053610|E1|Reported Event|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
54815|NCT02053493|B3|Baseline|Total|Total of all reporting groups
54816|NCT02053493|B2|Baseline|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54817|NCT02053493|B1|Baseline|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54818|NCT02053493|P2|Participant Flow|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54819|NCT02053493|P1|Participant Flow|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54820|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54821|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54822|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54823|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54824|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54864|NCT02052895|O1|Outcome|Presepsin|ROC-AUC of presepsin for discriminating between Sepsis and SIRS
54865|NCT02052895|E3|Reported Event|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
54866|NCT02052895|E2|Reported Event|Control|Patients without SIRS, sepsis, or end stage renal disease
54870|NCT02052752|B2|Baseline|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54825|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54826|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54827|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54828|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54829|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54830|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54831|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54832|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54833|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54834|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54835|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54836|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54837|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54838|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54839|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54840|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54867|NCT02052895|E1|Reported Event|Sepsis/SIRS|Patients with sepsis or SIRS
54868|NCT02052752|B4|Baseline|Total|Total of all reporting groups
55123|NCT02049450|O2|Outcome|15mg Bid|Patients who received INC422 15mg bid
55124|NCT02049450|O1|Outcome|10 mg Bid|Patients who received INC422 10mg bid
54841|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54842|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54843|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54844|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54845|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54846|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54847|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54848|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54849|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54850|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54851|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54852|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54853|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54854|NCT02053493|E2|Reported Event|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
54855|NCT02053493|E1|Reported Event|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)
Isosorbide Mononitrate: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
54856|NCT02052895|B4|Baseline|Total|Total of all reporting groups
54857|NCT02052895|B3|Baseline|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
54858|NCT02052895|B2|Baseline|Control|Patients without SIRS, sepsis, or end stage renal disease
54859|NCT02052895|B1|Baseline|Sepsis/SIRS|Patients with sepsis or SIRS
54860|NCT02052895|P3|Participant Flow|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
54861|NCT02052895|P2|Participant Flow|Control|Patients without SIRS, sepsis, or end stage renal disease
54862|NCT02052895|P1|Participant Flow|Sepsis/SIRS|Patients with sepsis or SIRS
54871|NCT02052752|B1|Baseline|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54872|NCT02052752|P3|Participant Flow|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54873|NCT02052752|P2|Participant Flow|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54874|NCT02052752|P1|Participant Flow|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54875|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54876|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54877|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54878|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3
54879|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54880|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54881|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54882|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54883|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54884|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54885|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54886|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54887|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54888|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54889|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54890|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54891|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54892|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54893|NCT02052752|E3|Reported Event|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54894|NCT02052752|E2|Reported Event|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54895|NCT02052752|E1|Reported Event|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
54896|NCT02052661|B1|Baseline|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
55125|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
54897|NCT02052661|P1|Participant Flow|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
54928|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54898|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
54899|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
54900|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
54901|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
54902|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
54903|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
54904|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
54905|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
54906|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
54907|NCT02052661|E1|Reported Event|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
54908|NCT02052635|B3|Baseline|Total|Total of all reporting groups
54909|NCT02052635|B2|Baseline|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
54910|NCT02052635|B1|Baseline|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
54911|NCT02052635|P2|Participant Flow|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
54912|NCT02052635|P1|Participant Flow|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
54913|NCT02052635|O2|Outcome|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
54914|NCT02052635|O1|Outcome|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
54915|NCT02052635|O2|Outcome|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
54916|NCT02052635|O1|Outcome|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
54917|NCT02052635|E2|Reported Event|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
54918|NCT02052635|E1|Reported Event|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
54919|NCT02052544|B1|Baseline|Plasma Samples From Subjects Receiving Unfractionated Heparin|A total of 123 valid patients were recruited over three clinical centers (two in Europe, one in the US). The patients were selected from subjects receiving UFH therapy and who have given written informed consent. Excluded from the study were subjects treated with any other anticoagulants other than UFH, subjects who have been undergoing fibrinolytic therapy within the previous 4 weeks, subjects known to have a congenital bleeding disorder, subjects known to show coagulation factor deficiencies and subjects known to have a coagulation inhibitor or an unexplained APTT prolongation.
54920|NCT02052544|P1|Participant Flow|Study Patients|Patients receiving unfractionated heparin (UFH)
54921|NCT02052544|O2|Outcome|Hemosil|Sensitivity and Specificity of Hemosil
54922|NCT02052544|O1|Outcome|Pefakit|Sensitivity and Specificity of Pefakit
54923|NCT02052544|E1|Reported Event|Study Patients|Patients receiving unfractionated heparin (UFH)
54924|NCT02052466|B1|Baseline|Reverse TSA Patients|Patients having undergone reverse Total Shoulder Arthroplasty (TSA) at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54925|NCT02052466|P1|Participant Flow|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54926|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54927|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
55217|NCT02046980|E3|Reported Event|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day
Sham"
54929|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54930|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54931|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54932|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54933|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54934|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54935|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54936|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54937|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54938|NCT02052466|E1|Reported Event|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
54939|NCT02052414|B1|Baseline|Gralise (Gabapentin ER)|"This is an open label trial to evaluate the efficacy of Gralise against fibromyalgia pain. If subject is taking gabapentinoids at the time of enrollment, subjects will be required to wash off the medication; otherwise they can start the starter pack for Gralise, and will eventually up titrated to treatment dose of 1800mg with evening meals per day.
Subjects will be followed every 4 weeks for total of 12 weeks. At the end of 12 weeks, subjects will be wash off the Gralise over 2 weeks, and will have a final end of treatment visit at week 15.
Subjects will be asked to rate their pain on numeric pain rating system (NPRS) as primary outcome measure. Subjects will be asked to assess Fibromyalgia Impact Questionnaire (FIQ), Medical Outcome Study (MOS) Sleep questionnaire, and Patient Global Impression of Change (PGIC) as secondary outcome measures.
At each follow up visits, occurrence of adverse events, and changes to concomitant medications were evaluated and recorded."
54940|NCT02052414|P1|Participant Flow|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
54941|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
54942|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
54943|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|All subjects were assessed for occurrence of adverse events at follow up visits. All reported adverse events were tabulated, and presented in this study.
54944|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
54971|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
Apneic Oxygenation"
54972|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
No Apneic Oxygenation"
54973|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.
Direct Laryngoscopy"
54974|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure
Video Laryngoscopy"
54945|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
54946|NCT02052414|E1|Reported Event|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
54947|NCT02052011|B3|Baseline|Total|Total of all reporting groups
54948|NCT02052011|B2|Baseline|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
54949|NCT02052011|B1|Baseline|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
54950|NCT02052011|P2|Participant Flow|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
54951|NCT02052011|P1|Participant Flow|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
54952|NCT02052011|O2|Outcome|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
54953|NCT02052011|O1|Outcome|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
54954|NCT02052011|E2|Reported Event|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
54955|NCT02052011|E1|Reported Event|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
54956|NCT02051816|B5|Baseline|Total|Total of all reporting groups
54957|NCT02051816|B4|Baseline|Direct Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
and
No apneic oxygenation"
54958|NCT02051816|B3|Baseline|Video Laryngoscopy and no Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
and
No apneic oxygenation"
54959|NCT02051816|B2|Baseline|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
and
A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure"
54960|NCT02051816|B1|Baseline|Video Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
and
A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure"
54961|NCT02051816|P4|Participant Flow|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.
Direct Laryngoscopy"
54962|NCT02051816|P3|Participant Flow|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure
Video Laryngoscopy"
54963|NCT02051816|P2|Participant Flow|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
Apneic Oxygenation"
54964|NCT02051816|P1|Participant Flow|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
No Apneic Oxygenation"
54965|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.
Direct Laryngoscopy"
54966|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure
Video Laryngoscopy"
54967|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
Apneic Oxygenation"
54968|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
No Apneic Oxygenation"
54969|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.
Direct Laryngoscopy"
54970|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure
Video Laryngoscopy"
55297|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
54975|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
Apneic Oxygenation"
54976|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
No Apneic Oxygenation"
54977|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.
Direct Laryngoscopy"
54978|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure
Video Laryngoscopy"
54979|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
Apneic Oxygenation"
54980|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
No Apneic Oxygenation"
54981|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.
Direct Laryngoscopy"
54982|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure
Video Laryngoscopy"
54983|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
Apneic Oxygenation"
54984|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
No Apneic Oxygenation"
54985|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.
Direct Laryngoscopy"
54986|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure
Video Laryngoscopy"
54987|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
Apneic Oxygenation"
54988|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
No Apneic Oxygenation"
54989|NCT02051816|O4|Outcome|No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.
Video Laryngoscopy
Direct Laryngoscopy"
54990|NCT02051816|O3|Outcome|Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure
Video Laryngoscopy
Direct Laryngoscopy"
54991|NCT02051816|O2|Outcome|Direct Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
Apneic Oxygenation
No Apneic Oxygenation"
54992|NCT02051816|O1|Outcome|Video Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
Apneic Oxygenation
No Apneic Oxygenation"
54993|NCT02051816|O4|Outcome|No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.
Video Laryngoscopy
Direct Laryngoscopy"
54994|NCT02051816|O3|Outcome|Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure
Video Laryngoscopy
Direct Laryngoscopy"
54995|NCT02051816|O2|Outcome|Direct Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
Apneic Oxygenation
No Apneic Oxygenation"
54996|NCT02051816|O1|Outcome|Video Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
Apneic Oxygenation
No Apneic Oxygenation"
54997|NCT02051816|E4|Reported Event|No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.
Video Laryngoscopy
Direct Laryngoscopy"
54998|NCT02051816|E3|Reported Event|Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure
Video Laryngoscopy
Direct Laryngoscopy"
54999|NCT02051816|E2|Reported Event|Direct Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.
Apneic Oxygenation
No Apneic Oxygenation"
55000|NCT02051816|E1|Reported Event|Video Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.
Apneic Oxygenation
No Apneic Oxygenation"
55001|NCT02051790|B1|Baseline|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.
florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
55002|NCT02051790|P1|Participant Flow|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.
florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
55218|NCT02046980|E2|Reported Event|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day
Vibration"
55003|NCT02051790|O1|Outcome|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.
florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
55004|NCT02051790|E1|Reported Event|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.
florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
55005|NCT02051595|B1|Baseline|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.
Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
55006|NCT02051595|P1|Participant Flow|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.
Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
55007|NCT02051595|O1|Outcome|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.
Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
55008|NCT02051595|E1|Reported Event|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.
Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
55009|NCT02051426|B3|Baseline|Total|Total of all reporting groups
55010|NCT02051426|B2|Baseline|Placebo First, Then D-serine|corn starch, then D-serine (2.1g)
55011|NCT02051426|B1|Baseline|D-serine First, Then Placebo|D-serine (2.1g), then placebo (corn starch)
55012|NCT02051426|P2|Participant Flow|Placebo First, Then D-serine|corn starch, then D-serine (2.1g)
55013|NCT02051426|P1|Participant Flow|D-serine First, Then Placebo|D-serine (2.1g), then Placebo (corn starch)
55014|NCT02051426|O2|Outcome|Placebo|corn starch
55015|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
55016|NCT02051426|O2|Outcome|Placebo|corn starch
55017|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
55018|NCT02051426|O2|Outcome|Placebo|corn starch
55019|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
55020|NCT02051426|E2|Reported Event|Placebo|corn starch
55021|NCT02051426|E1|Reported Event|D-serine|D-serine (2.1g)
55022|NCT02051335|B5|Baseline|Total|Total of all reporting groups
55023|NCT02051335|B4|Baseline|Sequence 4 (DACB)|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
55024|NCT02051335|B3|Baseline|Sequence 3 (CDBA)|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
55025|NCT02051335|B2|Baseline|Sequence 2 (BCAD)|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
55026|NCT02051335|B1|Baseline|Sequence 1 (ABDC)|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
55048|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
56906|NCT02036541|E1|Reported Event|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
55049|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55129|NCT02049450|E1|Reported Event|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
55027|NCT02051335|P4|Participant Flow|Sequence 4 (DACB)|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
55028|NCT02051335|P3|Participant Flow|Sequence 3 (CDBA)|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
55029|NCT02051335|P2|Participant Flow|Sequence 2 (BCAD)|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
55030|NCT02051335|P1|Participant Flow|Sequence 1 (ABDC)|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
55031|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55032|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55033|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55034|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55035|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55036|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55037|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55038|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55039|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55040|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55041|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55042|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55043|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55044|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55045|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55046|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55047|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55050|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55051|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55052|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55053|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55054|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55055|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55056|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55057|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55058|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55059|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55060|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55061|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55062|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55063|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55064|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55065|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55066|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55067|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55068|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55069|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55070|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55071|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55072|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55073|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55074|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55075|NCT02051335|E4|Reported Event|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55076|NCT02051335|E3|Reported Event|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55077|NCT02051335|E2|Reported Event|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55078|NCT02051335|E1|Reported Event|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
55080|NCT02050334|B2|Baseline|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo"
55081|NCT02050334|B1|Baseline|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100"
55082|NCT02050334|P2|Participant Flow|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo"
55083|NCT02050334|P1|Participant Flow|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100"
55084|NCT02050334|O1|Outcome|CC100 Single Doses|CC100: 2, 5, 10, and 20 mg/kg doses.
55085|NCT02050334|O1|Outcome|CC100 Single Doses|CC100: 2, 5, 10, and 20 mg/kg doses.
55086|NCT02050334|O2|Outcome|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo"
55087|NCT02050334|O1|Outcome|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100"
55088|NCT02050334|E2|Reported Event|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo"
55089|NCT02050334|E1|Reported Event|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100"
55090|NCT02050321|B1|Baseline|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.
Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
55091|NCT02050321|P1|Participant Flow|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.
Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
55092|NCT02050321|O1|Outcome|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.
Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
55093|NCT02050321|E1|Reported Event|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.
Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
55094|NCT02050048|B3|Baseline|Total|Total of all reporting groups
55095|NCT02050048|B2|Baseline|Low Volume Group (Control Arm)|In the low volume group (control arm), patients will receive intravenous Lactated Ringer's solution at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
55096|NCT02050048|B1|Baseline|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
LR fluid infusion during the procedure at 5 cc/kg/hr
Post-procedure bolus of 20 cc/kg over 90 minutes"
55097|NCT02050048|P2|Participant Flow|Low Volume Group (Control Arm)|In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
55098|NCT02050048|P1|Participant Flow|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
LR fluid infusion during the procedure at 5 cc/kg/hr
Post-procedure bolus of 20 cc/kg over 90 minutes"
55120|NCT02049450|O2|Outcome|10mg Bid|Patients who received INC422 10mg bid
55121|NCT02049450|O1|Outcome|5mg Bid|Patients who received INC422 5mg bid
55122|NCT02049450|O3|Outcome|20mg Bid|Patients who received INC422 20mg bid
55130|NCT02049151|B3|Baseline|Total Title|
55219|NCT02046980|E1|Reported Event|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day
Gufoni"
55442|NCT02044848|B2|Baseline|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
55099|NCT02050048|O2|Outcome|Low Volume Group (Control Arm)|Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period.
55100|NCT02050048|O1|Outcome|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
LR fluid infusion during the procedure at 5 cc/kg/hr
Post-procedure bolus of 20 cc/kg over 90 minutes"
55101|NCT02050048|E2|Reported Event|Low Volume Group (Control Arm)|Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
55102|NCT02050048|E1|Reported Event|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
LR fluid infusion during the procedure at 5 cc/kg/hr
Post-procedure bolus of 20 cc/kg over 90 minutes"
55103|NCT02049931|B4|Baseline|Total|Total of all reporting groups
55104|NCT02049931|B3|Baseline|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.
Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks. Then, weaning period requires additional 4 weeks."
55105|NCT02049931|B2|Baseline|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks. Then, weaning period requires additional 4 weeks."
55106|NCT02049931|B1|Baseline|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.
No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
55107|NCT02049931|P3|Participant Flow|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.
Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
55108|NCT02049931|P2|Participant Flow|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
55109|NCT02049931|P1|Participant Flow|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.
No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
55110|NCT02049931|O3|Outcome|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.
Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
55111|NCT02049931|O2|Outcome|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
55112|NCT02049931|O1|Outcome|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.
No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
55113|NCT02049931|E3|Reported Event|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.
Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
55114|NCT02049931|E2|Reported Event|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
55115|NCT02049931|E1|Reported Event|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.
No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
55116|NCT02049450|B1|Baseline|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
55117|NCT02049450|P1|Participant Flow|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
55118|NCT02049450|O4|Outcome|20mg Bid|Patients who received INC422 20mg bid
55119|NCT02049450|O3|Outcome|15mg Bid|Patients who received INC422 15mg bid
55131|NCT02049151|B2|Baseline|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
55132|NCT02049151|B1|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
55133|NCT02049151|P2|Participant Flow|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
55134|NCT02049151|P1|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 micrograms [mcg]) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
55135|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
55136|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
55137|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
55138|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
55139|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
55140|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
55141|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
55142|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
55143|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
55144|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
55209|NCT02046980|B2|Baseline|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day
Vibration"
56907|NCT02036515|B4|Baseline|Total|Total of all reporting groups
55145|NCT02049151|E2|Reported Event|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
55213|NCT02046980|P1|Participant Flow|Gufoni|"Gufoni maneuver for apogeotropic horizontal benign paroxysmal positional vertigo (BPPV) at the first day
Gufoni"
55146|NCT02049151|E1|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 micrograms [mcg]) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented
55147|NCT02048904|B1|Baseline|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months
Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
55148|NCT02048904|P1|Participant Flow|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months
Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
55149|NCT02048904|O1|Outcome|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months
Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
55150|NCT02048904|E1|Reported Event|Sitagliptin or Placebo|"100 mg/day for 3 months or 1 pill/day for 3 months
Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months"
55151|NCT02048891|B3|Baseline|Total|Total of all reporting groups
55152|NCT02048891|B2|Baseline|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
GnRH agonist trigger"
55153|NCT02048891|B1|Baseline|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
hCG trigger"
55154|NCT02048891|P2|Participant Flow|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
GnRH agonist trigger"
55155|NCT02048891|P1|Participant Flow|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
hCG trigger"
55156|NCT02048891|O2|Outcome|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
GnRH agonist trigger"
55157|NCT02048891|O1|Outcome|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
hCG trigger"
55158|NCT02048891|E2|Reported Event|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
GnRH agonist trigger"
55159|NCT02048891|E1|Reported Event|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
hCG trigger"
55160|NCT02048072|B1|Baseline|Gilenya|Gilenya 0.5mg p.o. once daily
55161|NCT02048072|P1|Participant Flow|Gilenya|Gilenya 0.5mg p.o. once daily
55162|NCT02048072|O1|Outcome|Gilenya|Gilenya 0.5mg p.o. once daily
55163|NCT02048072|E1|Reported Event|Gilenya|Gilenya 0.5mg p.o. once daily
55164|NCT02047747|B1|Baseline|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
55165|NCT02047747|P1|Participant Flow|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
55166|NCT02047747|O1|Outcome|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
55167|NCT02047747|O1|Outcome|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
55168|NCT02047747|E1|Reported Event|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
55169|NCT02047227|B3|Baseline|Total|Total of all reporting groups
55170|NCT02047227|B2|Baseline|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
55171|NCT02047227|B1|Baseline|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
55172|NCT02047227|P2|Participant Flow|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
55173|NCT02047227|P1|Participant Flow|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
55174|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
55175|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
55176|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
55177|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
55178|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
55179|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
55180|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
55181|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
55182|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
55183|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
55184|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
55185|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
55186|NCT02047227|E2|Reported Event|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
55210|NCT02046980|B1|Baseline|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day
Gufoni"
55211|NCT02046980|P3|Participant Flow|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day
Sham"
55212|NCT02046980|P2|Participant Flow|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day
Vibration"
56908|NCT02036515|B3|Baseline|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
55214|NCT02046980|O3|Outcome|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day
Sham"
55215|NCT02046980|O2|Outcome|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day
Vibration"
55216|NCT02046980|O1|Outcome|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day
Gufoni"
89785|NCT01843374|P1|Participant Flow|PLACEBO|Placebo.
55187|NCT02047227|E1|Reported Event|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
55188|NCT02046993|B3|Baseline|Total|Total of all reporting groups
55189|NCT02046993|B2|Baseline|Hypertensive Patients on Usual Care|"Hypertensive patients on usual care
. Patients to do HBP measurement
. Record BP readings in their diary
Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
55190|NCT02046993|B1|Baseline|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)
. Patients do HBP monitoring
. record their BP readings into the smart phone with downloaded application.
Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
55191|NCT02046993|P2|Participant Flow|Hypertensive Patients on Enahnced Usual Care|"Hypertensive patients on usual care
. Patients to do HBP measurement
. Record BP readings in their diary
Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
55192|NCT02046993|P1|Participant Flow|Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care|"Smart phone based telemonitoring home blood pressure (HBP)
. Patients do HBP monitoring
. record their BP readings into the smart phone with downloaded application.
Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
55193|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care
. Patients to do HBP measurement
. Record BP readings in their diary
Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
55194|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)
. Patients do HBP monitoring
. record their BP readings into the smart phone with downloaded application.
Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
55195|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care
. Patients to do HBP measurement
. Record BP readings in their diary
Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
55196|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)
. Patients do HBP monitoring
. record their BP readings into the smart phone with downloaded application.
Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
55197|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care
. Patients to do HBP measurement
. Record BP readings in their diary
Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
55198|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)
. Patients do HBP monitoring
. record their BP readings into the smart phone with downloaded application.
Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
55199|NCT02046993|O2|Outcome|Hypertensive Patients on Enahnced Usual Care|"Hypertensive patients on usual care
. Patients to do HBP measurement
. Record BP readings in their diary
Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
55200|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care|"Smart phone based telemonitoring home blood pressure (HBP)
. Patients do HBP monitoring
. record their BP readings into the smart phone with downloaded application.
Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
55201|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care
. Patients to do HBP measurement
. Record BP readings in their diary
Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
55202|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)
. Patients do HBP monitoring
. record their BP readings into the smart phone with downloaded application.
Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
55203|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care
. Patients to do HBP measurement
. Record BP readings in their diary
Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
55204|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)
. Patients do HBP monitoring
. record their BP readings into the smart phone with downloaded application.
Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
55205|NCT02046993|E2|Reported Event|Enhanced Usual Care|". Patients to do HBP measurement
. Record BP readings in their diary
Enhanced usual care: Encouraged to do HBP measurement and record BP readings in paper diary"
55206|NCT02046993|E1|Reported Event|Smart Phone Based Telemonitoring of HBP|". Patients do HBP monitoring
. record their BP readings into the smart phone with downloaded application.
Smart phone telemonitoring HBP + enhanced usual care: Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary"
55207|NCT02046980|B4|Baseline|Total|Total of all reporting groups
55208|NCT02046980|B3|Baseline|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day
Sham"
98072|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID
ELND005"
55220|NCT02046863|B1|Baseline|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.
Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
55221|NCT02046863|P1|Participant Flow|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.
Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
55222|NCT02046863|O1|Outcome|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.
Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
55223|NCT02046863|E1|Reported Event|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.
Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
55224|NCT02046772|B3|Baseline|Total|Total of all reporting groups
55225|NCT02046772|B2|Baseline|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
55226|NCT02046772|B1|Baseline|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
55227|NCT02046772|P2|Participant Flow|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
55228|NCT02046772|P1|Participant Flow|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
55229|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
55230|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
55231|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
55232|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
55233|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
55234|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
55235|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
55236|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
55237|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
55238|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
55295|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
55239|NCT02046772|E2|Reported Event|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
55240|NCT02046772|E1|Reported Event|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
55241|NCT02046265|B5|Baseline|Total|Total of all reporting groups
55437|NCT02044991|O2|Outcome|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
55242|NCT02046265|B4|Baseline|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55243|NCT02046265|B3|Baseline|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.
Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55244|NCT02046265|B2|Baseline|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55245|NCT02046265|B1|Baseline|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55246|NCT02046265|P4|Participant Flow|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55247|NCT02046265|P3|Participant Flow|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.
Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55248|NCT02046265|P2|Participant Flow|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55249|NCT02046265|P1|Participant Flow|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55250|NCT02046265|O4|Outcome|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55251|NCT02046265|O3|Outcome|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.
Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55252|NCT02046265|O2|Outcome|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55253|NCT02046265|O1|Outcome|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55254|NCT02046265|E4|Reported Event|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55255|NCT02046265|E3|Reported Event|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.
Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55256|NCT02046265|E2|Reported Event|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55257|NCT02046265|E1|Reported Event|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
55296|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55258|NCT02046226|B1|Baseline|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
55259|NCT02046226|P1|Participant Flow|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
55260|NCT02046226|O2|Outcome|Standard Wound Care|Standard wound care using gauze dressings per institutional standard of care.
55261|NCT02046226|O1|Outcome|OxyGenesys(TM) Dissolved Oxygen Dressing|"OxyGenesys(TM) Dissolved Oxygen Dressing
Oxygenesys(TM) Dissolved Oxygen Dressing: OxyGenesys(TM) Dissolved Oxygen Dressing"
55262|NCT02046226|O2|Outcome|Standard Wound Care|Standard wound care using gauze dressings per institutional standard of care.
55263|NCT02046226|O1|Outcome|OxyGenesys(TM) Dissolved Oxygen Dressing|"OxyGenesys(TM) Dissolved Oxygen Dressing
Oxygenesys(TM) Dissolved Oxygen Dressing: OxyGenesys(TM) Dissolved Oxygen Dressing"
55264|NCT02046226|E1|Reported Event|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated on each case report form.
55265|NCT02046200|B1|Baseline|IVM 30mg; Placebo|"Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Placebo: Single dose sugar pill matched to active medication."
55266|NCT02046200|P2|Participant Flow|Placebo First, Then IVM 30 mg|"First Intervention, Placebo: Single dose sugar pill, matched to active medication.
Second Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin."
55267|NCT02046200|P1|Participant Flow|IVM 30mg First, Then Placebo|"First Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Second Intervention, Placebo: Single dose sugar pill, matched to active medication."
55268|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55269|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
55270|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55271|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55272|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55273|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55274|NCT02046200|O6|Outcome|IVM 30mg (BrAC = 0.08)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
55275|NCT02046200|O5|Outcome|IVM 30mg (BrAC = 0.04)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
55276|NCT02046200|O4|Outcome|IVM 30mg (BrAC = 0.00)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
55277|NCT02046200|O3|Outcome|Placebo (BrAC = 0.08)|Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
55278|NCT02046200|O2|Outcome|Placebo (BrAC = 0.04)|Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.04.
55279|NCT02046200|O1|Outcome|Placebo (BrAC = 0.00)|Single dose sugar pill, matched to active medication. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
55280|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55281|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
55282|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55283|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
55284|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55285|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
55286|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55287|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
55288|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55289|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
55290|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55291|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
55292|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55293|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
55294|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55298|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55299|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
55300|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
55301|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
55302|NCT02046200|E2|Reported Event|Placebo|"Matched placebo, single dose
Placebo: sugar pill
Alcohol"
55443|NCT02044848|B1|Baseline|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
55303|NCT02046200|E1|Reported Event|IVM 30mg|"Ivermectin 30 mg single dose
Ivermectin: Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin.
Alcohol"
55304|NCT02046148|B3|Baseline|Total|Total of all reporting groups
55305|NCT02046148|B2|Baseline|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55306|NCT02046148|B1|Baseline|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55307|NCT02046148|P2|Participant Flow|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55308|NCT02046148|P1|Participant Flow|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55309|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55310|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55311|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55312|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55313|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55314|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55315|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55316|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55317|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55318|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55319|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55320|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55416|NCT02045264|E1|Reported Event|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55417|NCT02045238|B3|Baseline|Total|Total of all reporting groups
55321|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55438|NCT02044991|O1|Outcome|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
55439|NCT02044991|E2|Reported Event|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
55322|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55323|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55324|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55325|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55326|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55327|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55328|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55329|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55330|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55331|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55332|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55333|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55334|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55335|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55336|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55337|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55338|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55339|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55435|NCT02044991|O2|Outcome|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
55340|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55341|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55342|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55343|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55344|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55345|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55346|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55347|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55348|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55349|NCT02046148|E2|Reported Event|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55350|NCT02046148|E1|Reported Event|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
55351|NCT02045836|B3|Baseline|Total|Total of all reporting groups
55352|NCT02045836|B2|Baseline|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55353|NCT02045836|B1|Baseline|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55354|NCT02045836|P2|Participant Flow|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55355|NCT02045836|P1|Participant Flow|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55356|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55357|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55358|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55436|NCT02044991|O1|Outcome|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
55359|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55360|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55361|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55362|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55363|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55364|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55365|NCT02045836|O1|Outcome|Overall Study Arm|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55366|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55367|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55368|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55369|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55370|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55371|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55372|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55373|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55374|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55375|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55376|NCT02045836|O2|Outcome|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55377|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55378|NCT02045836|O1|Outcome|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55379|NCT02045836|E2|Reported Event|Control Group|Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55380|NCT02045836|E1|Reported Event|Co-Ad Group|Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
55381|NCT02045732|B3|Baseline|Total|Total of all reporting groups
55382|NCT02045732|B2|Baseline|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
55383|NCT02045732|B1|Baseline|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
55384|NCT02045732|P2|Participant Flow|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 milligram (mg)/kilogram (kg) SC every other week during an 85-day treatment period.
55385|NCT02045732|P1|Participant Flow|Placebo|Participants received placebo subcutaneously (SC) every other week during an 85-day treatment period.
55386|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
55387|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
55388|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
55389|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
55390|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
55391|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
55392|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
55393|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
55394|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
55395|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
55396|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
55397|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
55398|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
55399|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
55400|NCT02045732|E2|Reported Event|PF-06342674|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
55401|NCT02045732|E1|Reported Event|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
55402|NCT02045264|B1|Baseline|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55403|NCT02045264|P1|Participant Flow|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55404|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55405|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55406|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55407|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55408|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55409|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55410|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55411|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55412|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55413|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55414|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
55415|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
56909|NCT02036515|B2|Baseline|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
55440|NCT02044991|E1|Reported Event|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
55441|NCT02044848|B3|Baseline|Total|Total of all reporting groups
56923|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
55418|NCT02045238|B2|Baseline|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
55419|NCT02045238|B1|Baseline|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
55420|NCT02045238|P2|Participant Flow|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
55421|NCT02045238|P1|Participant Flow|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
55422|NCT02045238|O2|Outcome|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
55423|NCT02045238|O1|Outcome|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
55424|NCT02045238|O2|Outcome|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
55425|NCT02045238|O1|Outcome|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
55426|NCT02045238|E2|Reported Event|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
55427|NCT02045238|E1|Reported Event|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
55428|NCT02044991|B3|Baseline|Total|Total of all reporting groups
55429|NCT02044991|B2|Baseline|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
55430|NCT02044991|B1|Baseline|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
55431|NCT02044991|P2|Participant Flow|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
55432|NCT02044991|P1|Participant Flow|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
55433|NCT02044991|O2|Outcome|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
55434|NCT02044991|O1|Outcome|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
55444|NCT02044848|P2|Participant Flow|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
55445|NCT02044848|P1|Participant Flow|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
55446|NCT02044848|O2|Outcome|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
55447|NCT02044848|O1|Outcome|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
55448|NCT02044848|E2|Reported Event|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
55449|NCT02044848|E1|Reported Event|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
55450|NCT02044822|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
55451|NCT02044822|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
55452|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
55453|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
55454|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
55455|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
55456|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
55457|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
55458|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
55459|NCT02044822|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
55460|NCT02044458|B3|Baseline|Total|Total of all reporting groups
55461|NCT02044458|B2|Baseline|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
55462|NCT02044458|B1|Baseline|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.
Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
55463|NCT02044458|P2|Participant Flow|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
55464|NCT02044458|P1|Participant Flow|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.
Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
55465|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
55466|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.
Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
55467|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
55468|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.
Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
55469|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
55470|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.
Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
55471|NCT02044458|E2|Reported Event|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
55472|NCT02044458|E1|Reported Event|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.
Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
55473|NCT02044393|B3|Baseline|Total|Total of all reporting groups
55474|NCT02044393|B2|Baseline|BI 691751 / IT+BI 691751|"Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2.
Oral administration with 240 mL water after intake of a standaridsed meal."
55498|NCT02044367|P2|Participant Flow|T1-R-T2|T1: pellets on food; R: hard capsule; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
56803|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
55475|NCT02044393|B1|Baseline|Itraconazole (IT) +BI 691751 / BI 691751|"Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2.
The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks.
Oral administration with 240 mL water after intake of a standardised meal."
55501|NCT02044367|O1|Outcome|T1 (Treatment A)|"T1: Pellets on food
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water."
55476|NCT02044393|P2|Participant Flow|BI 691751 / IT+BI 691751|"Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2.
Oral administration with 240 mL water after intake of a standaridsed meal."
55477|NCT02044393|P1|Participant Flow|Itraconazole (IT) +BI 691751 / BI 691751|"Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2.
The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks.
Oral administration with 240 mL water after intake of a standardised meal."
55478|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
55479|NCT02044393|O1|Outcome|BI 691751|10 mg BI 691751 single dose oral administration with 240 mL water after intake of a standard meal.
55480|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
55481|NCT02044393|O1|Outcome|BI 691751|10 mg BI 691751 single dose oral administration with 240 mL water after intake of a standard meal.
55482|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
55483|NCT02044393|O1|Outcome|BI 691751|"single dose BI 691751
BI 691751: 10 mg single dose oral administration with 240 mL water after intake of a standard meal."
55484|NCT02044393|E5|Reported Event|Total on Treatment|combination of BI 691751, loading IT and BI 691751+ further IT.
55485|NCT02044393|E4|Reported Event|Total BI 691751|total subjects with BI 691751 treatment (either BI 691751 alone or IT+BI 691751)
55486|NCT02044393|E3|Reported Event|BI 691751 + Further IT|10 mg of BI 691751 in combination with multiple oral doses of itraconazole (only in the test treatment period after the introductory treatment with itraconazole alone over three days).
55487|NCT02044393|E2|Reported Event|Loading Itraconazole (IT)|200 mg of itraconazole (introductory treatment with itraconazole over three days, prior to the first administration of BI 691751 only in the test treatment period).
55488|NCT02044393|E1|Reported Event|BI 691751|10 mg single dose oral administration with 240 mL water after intake of a standard meal. (only in the reference treatment period)
55489|NCT02044380|B1|Baseline|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
55490|NCT02044380|P1|Participant Flow|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
55491|NCT02044380|O1|Outcome|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
55492|NCT02044380|E1|Reported Event|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
55493|NCT02044367|B1|Baseline|Overall|A randomised, open-label, 3-way crossover, multiple dose trial consisting of 3 identical treatment periods of 3 days. Study drug (150 mg dabigatran etexilate) was administrated twice daily on Day 1 and Day 2 and once on Day 3. The dosage forms used were: hard capsule, granules resolved in reconstitution solution and pellets on food. Treatment periods were separated by a washout phase of at least 5 days between last drug administration of one treatment and the first drug administration of the next treatment.
55494|NCT02044367|P6|Participant Flow|R-T2-T1|R: hard capsule; T2: granules for reconstitution into solution; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
55495|NCT02044367|P5|Participant Flow|R-T1-T2|R: hard capsule; T1: pellets on food; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
55496|NCT02044367|P4|Participant Flow|T2-R-T1|T2: granules for reconstitution into solution; R: hard capsule; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
55497|NCT02044367|P3|Participant Flow|T2-T1-R|T2: granules for reconstitution into solution; T1: pellets on food; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
55880|NCT02041286|B1|Baseline|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
55499|NCT02044367|P1|Participant Flow|T1-T2-R|T1: pellets on food; T2: granules for reconstitution into solution; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
55500|NCT02044367|O2|Outcome|T2 (Treatment B)|"T2: Granules resolved in reconstitution solution
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water."
89786|NCT01843374|O2|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
55502|NCT02044367|O2|Outcome|T2 (Treatment B)|T2: Granules resolved in reconstitution solution The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
55503|NCT02044367|O1|Outcome|T1 (Treatment A)|T1: Pellets on food The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
55504|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55505|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55506|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55507|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55508|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55509|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55510|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55511|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55512|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55513|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55514|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55515|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)
The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
55516|NCT02044367|E3|Reported Event|R (Reference)|multiple dose of dabigatran (Hard capsule) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
55517|NCT02044367|E2|Reported Event|T2 (Treatment B)|multiple dose of dabigatran (Granules resolved in reconstitution solution) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
55518|NCT02044367|E1|Reported Event|T1 (Treatment A)|multiple dose of dabigatran (Pellets). The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
55519|NCT02044302|B3|Baseline|Total|Total of all reporting groups
55520|NCT02044302|B2|Baseline|Blinded Group B|
55521|NCT02044302|B1|Baseline|Blinded Group A|
55522|NCT02044302|P2|Participant Flow|Blinded Group B|
55523|NCT02044302|P1|Participant Flow|Blinded Group A|
55524|NCT02044302|O1|Outcome|Terminated Cohort|
55525|NCT02044302|O1|Outcome|Terminated Cohort|
55526|NCT02044302|O1|Outcome|Terminated Cohort|
55527|NCT02044302|E1|Reported Event|Terminated Cohort|
55528|NCT02043808|B3|Baseline|Total|Total of all reporting groups
98073|NCT01791725|O3|Outcome|Placebo|"Placebo BID
Placebo"
55529|NCT02043808|B2|Baseline|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55530|NCT02043808|B1|Baseline|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55531|NCT02043808|P2|Participant Flow|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55578|NCT02043782|O1|Outcome|Coloplast Test Product|Subjects testing Coloplast test product
55532|NCT02043808|P1|Participant Flow|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55533|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55534|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55535|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55536|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55537|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55538|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55539|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55540|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55541|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55542|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55543|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55544|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55545|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55546|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55547|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55548|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55549|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55550|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55551|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55552|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55553|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55554|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
56910|NCT02036515|B1|Baseline|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
55555|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55556|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55557|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55558|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55559|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55560|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55561|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55562|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55563|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55564|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55565|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55566|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55567|NCT02043808|E2|Reported Event|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
55568|NCT02043808|E1|Reported Event|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
55569|NCT02043782|B1|Baseline|All Subjects|Pooled data from all arms.
55570|NCT02043782|P6|Participant Flow|Test - Own - Competitor|"The subjects were randomized into six possible treatment groups:
The order of test products for this group was:
Coloplast test product Own product Competitor soft convex product
Coloplast Test: Newly developed 1-piece convex ostomy product
Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.
Competitor soft convex: A commercially available soft convex product"
55571|NCT02043782|P5|Participant Flow|Own - Competitor - Test|"The subjects were randomized into six possible treatment groups:
The order of test products for this group was:
Own product Competitor soft convex product Coloplast test product
Coloplast Test: Newly developed 1-piece convex ostomy product
Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.
Competitor soft convex: A commercially available soft convex product"
55572|NCT02043782|P4|Participant Flow|Competitor - Test - Own|"The subjects were randomized into six possible treatment groups:
The order of test products for this group was:
Competitor soft convex product Coloplast test product Own product
Coloplast Test: Newly developed 1-piece convex ostomy product
Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.
Competitor soft convex: A commercially available soft convex product"
55573|NCT02043782|P3|Participant Flow|Own - Test - Competitor|"The subjects were randomized into six possible treatment groups:
The order of test products for this group was:
Own product Coloplast test product Competitor soft convex product
Coloplast Test: Newly developed 1-piece convex ostomy product
Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.
Competitor soft convex: A commercially available soft convex product"
55574|NCT02043782|P2|Participant Flow|Competitor - Own - Test|"The subjects were randomized into six possible treatment groups:
The order of test products for this group was:
Competitor soft convex product Own product Coloplast test product
Coloplast Test: Newly developed 1-piece convex ostomy product
Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.
Competitor soft convex: A commercially available soft convex product"
55938|NCT02040623|P3|Participant Flow|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day
Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
55575|NCT02043782|P1|Participant Flow|Test - Competitor - Own|"The subjects were randomized into six possible treatment groups:
The order of test products for this group was:
Coloplast test product Competitor soft convex product Own product
Coloplast Test: Newly developed 1-piece convex ostomy product
Own product: The subject's own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.
Competitor soft convex: A commercially available soft convex product"
55576|NCT02043782|O3|Outcome|Competitor Soft Convex|Subjects testing Competitor Soft Convex
55577|NCT02043782|O2|Outcome|Own Product|Subjects testing own product
55579|NCT02043782|E3|Reported Event|Competitor Soft Convex|Adverse events reported by subjects testing Competitor soft convex
55580|NCT02043782|E2|Reported Event|Own Product|Adverse events reported by subjects testing own product
55581|NCT02043782|E1|Reported Event|Coloplast Test Product|Adverse events reported by subjects testing Coloplast test product
55582|NCT02043379|B3|Baseline|Total|Total of all reporting groups
55583|NCT02043379|B2|Baseline|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55584|NCT02043379|B1|Baseline|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55585|NCT02043379|P2|Participant Flow|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55586|NCT02043379|P1|Participant Flow|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55587|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55588|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55589|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55590|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55591|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55592|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55593|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55594|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55595|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55596|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
56002|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer"
55597|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55598|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
56821|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
55599|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55600|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55601|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55602|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55603|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55604|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55605|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55606|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55607|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55608|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55609|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55610|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55611|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55612|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55613|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55614|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55615|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55616|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55617|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55618|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55619|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55620|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55621|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55622|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55623|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55624|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55625|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55626|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55627|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55628|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55629|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55630|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55631|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55632|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55633|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55634|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55635|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55636|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55637|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55638|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55639|NCT02043379|E2|Reported Event|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.
Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
55640|NCT02043379|E1|Reported Event|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.
IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
55641|NCT02043366|B7|Baseline|Total|Total of all reporting groups
55642|NCT02043366|B6|Baseline|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.
55643|NCT02043366|B5|Baseline|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
55644|NCT02043366|B4|Baseline|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
55645|NCT02043366|B3|Baseline|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil
Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
55646|NCT02043366|B2|Baseline|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
55647|NCT02043366|B1|Baseline|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
Normal Saline"
55648|NCT02043366|P6|Participant Flow|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.
55649|NCT02043366|P5|Participant Flow|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/kg butorphanol and a dose of 0.5mg/kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
55650|NCT02043366|P4|Participant Flow|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
55651|NCT02043366|P3|Participant Flow|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil
Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
55652|NCT02043366|P2|Participant Flow|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
55653|NCT02043366|P1|Participant Flow|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
Normal Saline"
55654|NCT02043366|O6|Outcome|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
55655|NCT02043366|O5|Outcome|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
55656|NCT02043366|O4|Outcome|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
55657|NCT02043366|O3|Outcome|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil
Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
56804|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
55658|NCT02043366|O2|Outcome|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
55659|NCT02043366|O1|Outcome|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
Normal Saline"
55660|NCT02043366|O6|Outcome|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
55941|NCT02040623|O3|Outcome|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day
Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
55661|NCT02043366|O5|Outcome|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
55662|NCT02043366|O4|Outcome|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
55663|NCT02043366|O3|Outcome|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil
Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
55664|NCT02043366|O2|Outcome|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
55665|NCT02043366|O1|Outcome|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
Normal Saline"
55666|NCT02043366|E6|Reported Event|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
55667|NCT02043366|E5|Reported Event|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentani
55668|NCT02043366|E4|Reported Event|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentani
55669|NCT02043366|E3|Reported Event|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil
Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
55670|NCT02043366|E2|Reported Event|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
55671|NCT02043366|E1|Reported Event|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
Normal Saline"
55672|NCT02043145|B4|Baseline|Total|Total of all reporting groups
55673|NCT02043145|B3|Baseline|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55674|NCT02043145|B2|Baseline|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55675|NCT02043145|B1|Baseline|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55676|NCT02043145|P3|Participant Flow|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55677|NCT02043145|P2|Participant Flow|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55678|NCT02043145|P1|Participant Flow|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55679|NCT02043145|O1|Outcome|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55680|NCT02043145|O1|Outcome|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55681|NCT02043145|O1|Outcome|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55682|NCT02043145|O3|Outcome|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55683|NCT02043145|O2|Outcome|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55684|NCT02043145|O1|Outcome|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55685|NCT02043145|E3|Reported Event|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55686|NCT02043145|E2|Reported Event|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55687|NCT02043145|E1|Reported Event|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
55688|NCT02043132|B3|Baseline|Total|Total of all reporting groups
55719|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
98074|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD
ELND005"
55720|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
55940|NCT02040623|P1|Participant Flow|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
55689|NCT02043132|B2|Baseline|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55690|NCT02043132|B1|Baseline|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55691|NCT02043132|P2|Participant Flow|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55692|NCT02043132|P1|Participant Flow|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55693|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55694|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55695|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55696|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55697|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55795|NCT02042131|P1|Participant Flow|Treatment As Usual (TAU)|"TAU includes the following intervention components:
suicide risk assessment
supportive listening
provision of professional and crisis contact information
referral to mental health treatment and community resources
verbal contract for safety
Treatment As Usual (TAU)"
55698|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55699|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55700|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55701|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55702|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55703|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55704|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55705|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55706|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55836|NCT02041520|B1|Baseline|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55707|NCT02043132|O2|Outcome|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55708|NCT02043132|O1|Outcome|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55709|NCT02043132|E2|Reported Event|Normal Saline|"Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Placebo: Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55710|NCT02043132|E1|Reported Event|Tranexamic Acid|"Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution."
55711|NCT02042924|B1|Baseline|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.
FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
55712|NCT02042924|P1|Participant Flow|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.
FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
55713|NCT02042924|O1|Outcome|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.
FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
55714|NCT02042924|O1|Outcome|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.
FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
55715|NCT02042924|O1|Outcome|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.
FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
55716|NCT02042924|E1|Reported Event|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.
FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
55717|NCT02042911|B1|Baseline|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
55718|NCT02042911|P1|Participant Flow|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
55794|NCT02042131|P2|Participant Flow|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)"
55721|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
55722|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
55723|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
55724|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
55725|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
55726|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
55727|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
55728|NCT02042911|E1|Reported Event|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
55729|NCT02042872|B3|Baseline|Total|Total of all reporting groups
55730|NCT02042872|B2|Baseline|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
55731|NCT02042872|B1|Baseline|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
55732|NCT02042872|P2|Participant Flow|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
55733|NCT02042872|P1|Participant Flow|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
55734|NCT02042872|O2|Outcome|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
55735|NCT02042872|O1|Outcome|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
55736|NCT02042872|O2|Outcome|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
55737|NCT02042872|O1|Outcome|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
55738|NCT02042872|E2|Reported Event|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
55739|NCT02042872|E1|Reported Event|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
55740|NCT02042534|B3|Baseline|Total|Total of all reporting groups
55741|NCT02042534|B2|Baseline|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].
Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
55877|NCT02041325|O1|Outcome|Lenalidomide|"Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.
Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks."
55796|NCT02042131|O3|Outcome|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify reasons for living
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Enhanced Crisis Response Plan (E-CRP)"
55742|NCT02042534|B1|Baseline|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.
Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.
The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
55743|NCT02042534|P2|Participant Flow|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].
Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
55744|NCT02042534|P1|Participant Flow|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.
Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.
The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
55745|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].
Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
55746|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.
Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.
The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
55747|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].
Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
55748|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.
Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.
The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
55749|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].
Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
55750|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.
Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.
The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
55751|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].
Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
55752|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.
Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.
The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
55753|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].
Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
55878|NCT02041325|E2|Reported Event|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
98075|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID
ELND005"
55754|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.
Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.
The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
55755|NCT02042534|E2|Reported Event|Warfarin|"Safety population : 90 (patients)
Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].
Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
55756|NCT02042534|E1|Reported Event|Rivaroxaban|"Safety population : 98 (patients)
Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.
Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.
The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
55757|NCT02042443|B3|Baseline|Total|Total of all reporting groups
55758|NCT02042443|B2|Baseline|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55759|NCT02042443|B1|Baseline|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55760|NCT02042443|P2|Participant Flow|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55761|NCT02042443|P1|Participant Flow|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55762|NCT02042443|O2|Outcome|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55763|NCT02042443|O1|Outcome|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55764|NCT02042443|O2|Outcome|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55765|NCT02042443|O1|Outcome|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55766|NCT02042443|O2|Outcome|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55767|NCT02042443|O1|Outcome|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
55768|NCT02042443|O2|Outcome|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55769|NCT02042443|O1|Outcome|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55770|NCT02042443|E2|Reported Event|Chemotherapy|Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55771|NCT02042443|E1|Reported Event|Trametinib|Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
55772|NCT02042404|B1|Baseline|Mild to Severe Hearing Impairment|Subjects wearing the Earlens System in their daily lives.
55773|NCT02042404|P2|Participant Flow|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
55774|NCT02042404|P1|Participant Flow|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.
Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
55879|NCT02041325|E1|Reported Event|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
55775|NCT02042404|O1|Outcome|Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.
Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
55776|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
55777|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.
Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
55778|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
55779|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.
Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
55780|NCT02042404|O1|Outcome|Mild to Severe Hearing Impairment|Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
55781|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
55782|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.
Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
55783|NCT02042404|E1|Reported Event|Mild to Severe Hearing Impairment|Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
55784|NCT02042274|B1|Baseline|Fish Oil|Fish oil supplements providing up to 3g per day of EPA and DHA, for 90 days.
55785|NCT02042274|P1|Participant Flow|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA
Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.
Measurements are made at three time points: Baseline (Day 0 - before beginning fish oil supplementation), 3 months (Day 90 - after fish oil supplementation), and 5 months (Day 150 - 2 month washout)."
55786|NCT02042274|O1|Outcome|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA
Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period."
55787|NCT02042274|O1|Outcome|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA
Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period."
55788|NCT02042274|E1|Reported Event|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA
Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period."
55789|NCT02042131|B4|Baseline|Total|Total of all reporting groups
55790|NCT02042131|B3|Baseline|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify reasons for living
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)
Enhanced Crisis Response Plan (E-CRP)"
55791|NCT02042131|B2|Baseline|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)"
55792|NCT02042131|B1|Baseline|Treatment As Usual (TAU)|"TAU includes the following intervention components:
suicide risk assessment
supportive listening
provision of professional and crisis contact information
referral to mental health treatment and community resources
verbal contract for safety
Treatment As Usual (TAU)"
55793|NCT02042131|P3|Participant Flow|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify reasons for living
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)
Enhanced Crisis Response Plan (E-CRP)"
56805|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
55797|NCT02042131|O2|Outcome|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Standard Crisis Response Plan (S-CRP)
Enhanced Crisis Response Plan (E-CRP)"
55798|NCT02042131|O1|Outcome|Treatment As Usual (TAU)|"TAU includes the following intervention components:
suicide risk assessment
supportive listening
provision of professional and crisis contact information
referral to mental health treatment and community resources
verbal contract for safety
Treatment As Usual (TAU)"
55799|NCT02042131|O3|Outcome|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify reasons for living
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (S-CRP)
Enhanced Crisis Response Plan (E-CRP)"
55800|NCT02042131|O2|Outcome|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (S-CRP)"
55801|NCT02042131|O1|Outcome|Treatment As Usual (TAU)|"TAU includes the following intervention components:
suicide risk assessment
supportive listening
provision of professional and crisis contact information
referral to mental health treatment and community resources
verbal contract for safety
Treatment As Usual (TAU)"
55802|NCT02042131|O3|Outcome|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify reasons for living
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (S-CRP)
Enhanced Crisis Response Plan (E-CRP)"
55803|NCT02042131|O2|Outcome|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (S-CRP)"
55804|NCT02042131|O1|Outcome|Treatment As Usual (TAU)|"TAU includes the following intervention components:
suicide risk assessment
supportive listening
provision of professional and crisis contact information
referral to mental health treatment and community resources
verbal contract for safety
Treatment As Usual (TAU)"
55805|NCT02042131|O3|Outcome|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify reasons for living
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Enhanced Crisis Response Plan (E-CRP)"
55806|NCT02042131|O2|Outcome|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Standard Crisis Response Plan (S-CRP)
Enhanced Crisis Response Plan (E-CRP)"
55807|NCT02042131|O1|Outcome|Treatment As Usual (TAU)|"TAU includes the following intervention components:
suicide risk assessment
supportive listening
provision of professional and crisis contact information
referral to mental health treatment and community resources
verbal contract for safety
Treatment As Usual (TAU)"
55808|NCT02042131|E3|Reported Event|Enhanced Crisis Response Plan (E-CRP)|"The E-CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify reasons for living
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)
Enhanced Crisis Response Plan (E-CRP)"
55809|NCT02042131|E2|Reported Event|Standard Crisis Response Plan (S-CRP)|"CRP includes the following intervention components:
suicide risk assessment
supportive listening
identify personal warning signs
identify self-management skills
identify social support contacts
provision of professional and crisis contact information
referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)"
55810|NCT02042131|E1|Reported Event|Treatment As Usual (TAU)|"TAU includes the following intervention components:
suicide risk assessment
supportive listening
provision of professional and crisis contact information
referral to mental health treatment and community resources
verbal contract for safety
Treatment As Usual (TAU)"
55811|NCT02041533|B3|Baseline|Total|Total of all reporting groups
55812|NCT02041533|B2|Baseline|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:
Squamous:
gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
55813|NCT02041533|B1|Baseline|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
55837|NCT02041520|P2|Participant Flow|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55838|NCT02041520|P1|Participant Flow|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
56822|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
55814|NCT02041533|P2|Participant Flow|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:
Squamous:
gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
55815|NCT02041533|P1|Participant Flow|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
55816|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:
Squamous:
gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
55817|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
55818|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:
Squamous:
gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
55819|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
55820|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:
Squamous:
gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
55821|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
55822|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:
Squamous:
gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
55823|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
55824|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:
Squamous:
gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
55825|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
55826|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:
Squamous:
gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
55827|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
55828|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:
Squamous:
gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
55829|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
55830|NCT02041533|O2|Outcome|Investigator Choice of Chemotherapy|"Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:
Squamous:
gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total)."
55831|NCT02041533|O1|Outcome|Nivolumab|Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
55832|NCT02041533|E2|Reported Event|INVESTIGATOR CHOICE|
55833|NCT02041533|E1|Reported Event|NIVOLUMAB 3 mg/kg|
55834|NCT02041520|B3|Baseline|Total|Total of all reporting groups
55835|NCT02041520|B2|Baseline|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55876|NCT02041325|O2|Outcome|Placebo|"Placebo will be administered for 7 days prior to and 7 days after the vaccine.
Placebo: Placebo will be administered for 7 days prior to and 7 days after the vaccine."
55839|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55840|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55841|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55842|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55843|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55844|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55845|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55846|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55847|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55848|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55849|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55850|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55851|NCT02041520|O2|Outcome|Placebo|Patiemts who received placebo for 6 months
55852|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|Patients who received omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and 2 in the night...
55853|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55854|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55855|NCT02041520|E2|Reported Event|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55856|NCT02041520|E1|Reported Event|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.
omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
55857|NCT02041377|B1|Baseline|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:
At least 60% of subjects will be younger than age 65
At least 10% of subjects will have type 1 diabetes
Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
55939|NCT02040623|P2|Participant Flow|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
56823|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
55858|NCT02041377|P1|Participant Flow|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:
At least 60% of subjects will be younger than age 65
At least 10% of subjects will have type 1 diabetes
Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
55859|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:
At least 60% of subjects will be younger than age 65
At least 10% of subjects will have type 1 diabetes
Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
55860|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:
At least 60% of subjects will be younger than age 65
At least 10% of subjects will have type 1 diabetes
Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
55861|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:
At least 60% of subjects will be younger than age 65
At least 10% of subjects will have type 1 diabetes
Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
55862|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:
At least 60% of subjects will be younger than age 65
At least 10% of subjects will have type 1 diabetes
Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
55863|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:
At least 60% of subjects will be younger than age 65
At least 10% of subjects will have type 1 diabetes
Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
55864|NCT02041377|E1|Reported Event|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:
At least 60% of subjects will be younger than age 65
At least 10% of subjects will have type 1 diabetes
Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
55865|NCT02041325|B3|Baseline|Total|Total of all reporting groups
55866|NCT02041325|B2|Baseline|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
55867|NCT02041325|B1|Baseline|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
55868|NCT02041325|P2|Participant Flow|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
55869|NCT02041325|P1|Participant Flow|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
55870|NCT02041325|O2|Outcome|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
55871|NCT02041325|O1|Outcome|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
55872|NCT02041325|O2|Outcome|Placebo|"Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
Placebo: Subjects will receive placebo for 7 days prior to and 7 days after the vaccine."
55873|NCT02041325|O1|Outcome|Lenalidomide|"Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine."
55874|NCT02041325|O2|Outcome|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
55875|NCT02041325|O1|Outcome|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
56972|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
55881|NCT02041286|P1|Participant Flow|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:
At least 60% of subjects will be younger than age 65
At least 10% of subjects will have type 1 diabetes
Karajishi Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
55882|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
55883|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Study staff test subject capillary blood and BG results are compared to reference method results obtained from subject capillary plasma.
55884|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
55885|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.
55886|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
55887|NCT02041286|E1|Reported Event|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:
At least 60% of subjects will be younger than age 65
At least 10% of subjects will have type 1 diabetes
Karajishi Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
55888|NCT02041221|B7|Baseline|Total|Total of all reporting groups
55889|NCT02041221|B6|Baseline|Placebo|
55890|NCT02041221|B5|Baseline|S0597 Dose 5|
55891|NCT02041221|B4|Baseline|S0597 Dose 4|
55892|NCT02041221|B3|Baseline|S0597 Dose 3|
55893|NCT02041221|B2|Baseline|S0597 Dose 2|"The subjects will receive placebo.
S0597: The subjects will receive S0597.
Placebo"
55894|NCT02041221|B1|Baseline|S0597 Dose 1|"Subjects will be administered with S0597
S0597: The subjects will receive S0597.
Placebo"
55895|NCT02041221|P6|Participant Flow|Placebo|Subjects will receive placebo
55896|NCT02041221|P5|Participant Flow|S0597 Dose 5|Subjects will receive SPARC1316 dose 5
55897|NCT02041221|P4|Participant Flow|S0597 Dose 4|Subjects will receive SPARC1316 dose 4
55898|NCT02041221|P3|Participant Flow|S0597 Dose 3|Subjects will receive SPARC1316 dose 3
55899|NCT02041221|P2|Participant Flow|S0597 Dose 2|Subjects will receive SPARC1316 dose 2
55900|NCT02041221|P1|Participant Flow|S0597 Dose 1|Subjects will be administered with SPARC1316 dose 1
55901|NCT02041221|O6|Outcome|Placebo|
55902|NCT02041221|O5|Outcome|S0597 Dose 5|
55903|NCT02041221|O4|Outcome|S0597 Dose 4|
55904|NCT02041221|O3|Outcome|S0597 Dose 3|
55905|NCT02041221|O2|Outcome|S0597 Dose 2|
55906|NCT02041221|O1|Outcome|S0597 Dose 1|"The subjects will receive placebo.
S0597: The subjects will receive S0597.
Placebo"
55907|NCT02041221|E6|Reported Event|Placebo|
55908|NCT02041221|E5|Reported Event|S0597 Dose 5|
55909|NCT02041221|E4|Reported Event|S0597 Dose 4|
55910|NCT02041221|E3|Reported Event|S0597 Dose 3|
55911|NCT02041221|E2|Reported Event|S0597 Dose 2|"The subjects will receive placebo.
S0597: The subjects will receive S0597.
Placebo"
55912|NCT02041221|E1|Reported Event|S0597 Dose 1|"Subjects will be administered with S0597
S0597: The subjects will receive S0597.
Placebo"
55913|NCT02040792|B6|Baseline|Total|Total of all reporting groups
55914|NCT02040792|B5|Baseline|350 mcg|"TD-4208
TD-4208"
55915|NCT02040792|B4|Baseline|175 mcg|"TD-4208
TD-4208"
55916|NCT02040792|B3|Baseline|88 mcg|"TD-4208
TD-4208"
55917|NCT02040792|B2|Baseline|44 mcg|"TD-4208
TD-4208"
55918|NCT02040792|B1|Baseline|Placebo|"Placebo
Placebo"
55919|NCT02040792|P5|Participant Flow|350 mcg|"TD-4208
TD-4208"
55920|NCT02040792|P4|Participant Flow|175 mcg|"TD-4208
TD-4208"
55921|NCT02040792|P3|Participant Flow|88 mcg|"TD-4208
TD-4208"
55922|NCT02040792|P2|Participant Flow|44 mcg|"TD-4208
TD-4208"
55923|NCT02040792|P1|Participant Flow|Placebo|"Placebo
Placebo"
55924|NCT02040792|O5|Outcome|350 mcg|"TD-4208
TD-4208"
55925|NCT02040792|O4|Outcome|175 mcg|"TD-4208
TD-4208"
55926|NCT02040792|O3|Outcome|88 mcg|"TD-4208
TD-4208"
55927|NCT02040792|O2|Outcome|44 mcg|"TD-4208
TD-4208"
55928|NCT02040792|O1|Outcome|Placebo|"Placebo
Placebo"
55929|NCT02040792|E5|Reported Event|350 mcg|"TD-4208
TD-4208"
55930|NCT02040792|E4|Reported Event|175 mcg|"TD-4208
TD-4208"
55931|NCT02040792|E3|Reported Event|88 mcg|"TD-4208
TD-4208"
55932|NCT02040792|E2|Reported Event|44 mcg|"TD-4208
TD-4208"
55933|NCT02040792|E1|Reported Event|Placebo|"Placebo
Placebo"
55934|NCT02040623|B4|Baseline|Total|Total of all reporting groups
55935|NCT02040623|B3|Baseline|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day
Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
55936|NCT02040623|B2|Baseline|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
55937|NCT02040623|B1|Baseline|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
56806|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
55942|NCT02040623|O2|Outcome|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
55943|NCT02040623|O1|Outcome|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
55944|NCT02040623|E3|Reported Event|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day
Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
55945|NCT02040623|E2|Reported Event|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
55946|NCT02040623|E1|Reported Event|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
55947|NCT02040532|B1|Baseline|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
55948|NCT02040532|P1|Participant Flow|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
55949|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
55950|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
55951|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
55952|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
55953|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
55954|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
55955|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
55956|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
55957|NCT02040532|E1|Reported Event|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
55958|NCT02040428|B3|Baseline|Total|Total of all reporting groups
55959|NCT02040428|B2|Baseline|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
55960|NCT02040428|B1|Baseline|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
55961|NCT02040428|P2|Participant Flow|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
55962|NCT02040428|P1|Participant Flow|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
55963|NCT02040428|O2|Outcome|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
55964|NCT02040428|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
55965|NCT02040428|O2|Outcome|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
56119|NCT02038907|B12|Baseline|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
55966|NCT02040428|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
55967|NCT02040428|O2|Outcome|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
56824|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
55968|NCT02040428|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
55969|NCT02040428|O2|Outcome|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
55970|NCT02040428|O1|Outcome|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
55971|NCT02040428|E2|Reported Event|TachoSil|TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
55972|NCT02040428|E1|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
55973|NCT02039817|B3|Baseline|Total|Total of all reporting groups
55974|NCT02039817|B2|Baseline|Severe Renal Impairment|Severe Renal Impairment subjects received one 50mg dose of IDN-6556
55975|NCT02039817|B1|Baseline|Healthy Volunteers|Health Volunteers received one 50mg dose of IDN-6556
55976|NCT02039817|P2|Participant Flow|Severe Renal Impairment|Severe Renal Impairment subjects were given a single 50mg dose of IDN-6556
55977|NCT02039817|P1|Participant Flow|Healthy Volumteers|Healthy volunteers were given a single 50mg dose of IDN-6556
55978|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
55979|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
55980|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
55981|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
55982|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
55983|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
55984|NCT02039817|E1|Reported Event|IDN-6556|A single 50mg dose of IDN-6556
55985|NCT02039778|B1|Baseline|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.
Stem Cell Radiotherapy (ScRT) and Temozolomide"
55986|NCT02039778|P1|Participant Flow|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.
Stem Cell Radiotherapy (ScRT) and Temozolomide"
55987|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.
Stem Cell Radiotherapy (ScRT) and Temozolomide"
55988|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.
Stem Cell Radiotherapy (ScRT) and Temozolomide"
55989|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.
Stem Cell Radiotherapy (ScRT) and Temozolomide"
55990|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.
Stem Cell Radiotherapy (ScRT) and Temozolomide"
55991|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.
Stem Cell Radiotherapy (ScRT) and Temozolomide"
55992|NCT02039778|E1|Reported Event|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.
Stem Cell Radiotherapy (ScRT) and Temozolomide"
55993|NCT02039687|B5|Baseline|Total|Total of all reporting groups
55994|NCT02039687|B4|Baseline|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer"
55995|NCT02039687|B3|Baseline|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
55996|NCT02039687|B2|Baseline|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
55997|NCT02039687|B1|Baseline|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
55998|NCT02039687|P4|Participant Flow|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer"
55999|NCT02039687|P3|Participant Flow|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56000|NCT02039687|P2|Participant Flow|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56001|NCT02039687|P1|Participant Flow|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56003|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56037|NCT02039427|O2|Outcome|Preketorolac|"Ketorolac 30 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56004|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56005|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56006|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer"
56007|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56008|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56009|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56010|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer"
56011|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56012|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56013|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56014|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer"
56015|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56016|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56017|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56018|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer"
56019|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56020|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56021|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56022|NCT02039687|E4|Reported Event|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer"
56023|NCT02039687|E3|Reported Event|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56024|NCT02039687|E2|Reported Event|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56025|NCT02039687|E1|Reported Event|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
56026|NCT02039427|B5|Baseline|Total|Total of all reporting groups
56027|NCT02039427|B4|Baseline|Dexamethasone|"Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery
Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml"
56028|NCT02039427|B3|Baseline|Postketorolac|"Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56029|NCT02039427|B2|Baseline|Preketorolac|"Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56030|NCT02039427|B1|Baseline|Placebo|"Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
Placebo: Normal saline 2 ml"
56031|NCT02039427|P4|Participant Flow|Dexamethasone|"Dexamethasone 10 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery
Dexamethasone: dexamethasone acetate 10 mg mixed with normal saline : total volume of 2 ml"
56032|NCT02039427|P3|Participant Flow|Postketorolac|"Normal saline(Placebo) 2 ml at 5 min before induction and Ketorolac 30 mg at 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56033|NCT02039427|P2|Participant Flow|Preketorolac|"Ketorolac 30 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56034|NCT02039427|P1|Participant Flow|Placebo|"Normal saline(Placebo) 2 ml at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery
Placebo: Normal saline 2 ml"
56035|NCT02039427|O4|Outcome|Dexamethasone|"Dexamethasone 10 mg at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery
Dexamethasone: dexamethasone acetate 10 mg mixed with normal saline : total volume of 2 ml"
56036|NCT02039427|O3|Outcome|Postketorolac|"Normal saline(Placebo) 2 ml at 5 min before induction and Ketorolac 30 mg at 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56038|NCT02039427|O1|Outcome|Placebo|"Normal saline(Placebo) 2 ml at 5 min before induction and Normal saline(Placebo) 2 ml at 10 min before end of surgery
Placebo: Normal saline 2 ml"
56039|NCT02039427|O4|Outcome|Dexamethasone|"Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery
Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml"
56040|NCT02039427|O3|Outcome|Postketorolac|"Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56041|NCT02039427|O2|Outcome|Preketorolac|"Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56042|NCT02039427|O1|Outcome|Placebo|"Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
Placebo: Normal saline 2 ml"
56043|NCT02039427|O4|Outcome|Dexamethasone|"Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery
Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml"
56044|NCT02039427|O3|Outcome|Postketorolac|"Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56045|NCT02039427|O2|Outcome|Preketorolac|"Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56046|NCT02039427|O1|Outcome|Placebo|"Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
Placebo: Normal saline 2 ml"
56047|NCT02039427|E4|Reported Event|Dexamethasone|"Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery
Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml"
56048|NCT02039427|E3|Reported Event|Postketorolac|"Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56049|NCT02039427|E2|Reported Event|Preketorolac|"Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml"
56050|NCT02039427|E1|Reported Event|Placebo|"Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
Placebo: Normal saline 2 ml"
56051|NCT02039414|B3|Baseline|Total|Total of all reporting groups
56052|NCT02039414|B2|Baseline|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
56053|NCT02039414|B1|Baseline|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
56054|NCT02039414|P2|Participant Flow|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
56055|NCT02039414|P1|Participant Flow|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
56056|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
56057|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
56058|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
56059|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
56060|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
56061|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
56062|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
56063|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
56064|NCT02039414|E2|Reported Event|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
56065|NCT02039414|E1|Reported Event|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
56066|NCT02038959|B3|Baseline|Total|Total of all reporting groups
56067|NCT02038959|B2|Baseline|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56068|NCT02038959|B1|Baseline|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56120|NCT02038907|B11|Baseline|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56121|NCT02038907|B10|Baseline|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56122|NCT02038907|B9|Baseline|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56125|NCT02038907|B6|Baseline|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56825|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
89787|NCT01843374|O1|Outcome|PLACEBO|Placebo.
56069|NCT02038959|P2|Participant Flow|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56070|NCT02038959|P1|Participant Flow|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56071|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56072|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56073|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56074|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56075|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56076|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56077|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56078|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56123|NCT02038907|B8|Baseline|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56079|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56080|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56081|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56082|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56083|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56084|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56085|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56086|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56087|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56088|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56124|NCT02038907|B7|Baseline|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56089|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56090|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56091|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56092|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56093|NCT02038959|E2|Reported Event|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
56094|NCT02038959|E1|Reported Event|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
56095|NCT02038933|B3|Baseline|Total|Total of all reporting groups
56096|NCT02038933|B2|Baseline|ASCT-ineligible|Autologous stem cell transplant ineligible
56097|NCT02038933|B1|Baseline|ASCT-failed|Autologous stem cell transplant failed
56098|NCT02038933|P1|Participant Flow|Nivolumab 3mg/kg|Nivolumab 3mg/kg administered as an IV infusion on Treatment Day 1 of each 14 day cycle until disease progression or discontinuation due to toxicity, withdrawal of study consent, or the study ends.
56099|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
56100|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
56101|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
56102|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
56103|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
56104|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
56105|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
56106|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
56107|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
56108|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
56109|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
56110|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
56111|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
56112|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
56113|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
56114|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
56115|NCT02038933|E1|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3mg/kg administered as an IV infusion on Treatment Day 1 of each 14 day cycle until disease progression or discontinuation due to toxicity, withdrawal of study consent, or the study ends.
56116|NCT02038907|B15|Baseline|Total|Total of all reporting groups
56117|NCT02038907|B14|Baseline|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56118|NCT02038907|B13|Baseline|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56973|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56126|NCT02038907|B5|Baseline|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56127|NCT02038907|B4|Baseline|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56128|NCT02038907|B3|Baseline|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56129|NCT02038907|B2|Baseline|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56130|NCT02038907|B1|Baseline|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56131|NCT02038907|P14|Participant Flow|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56132|NCT02038907|P13|Participant Flow|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56133|NCT02038907|P12|Participant Flow|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56134|NCT02038907|P11|Participant Flow|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56135|NCT02038907|P10|Participant Flow|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56136|NCT02038907|P9|Participant Flow|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56137|NCT02038907|P8|Participant Flow|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56138|NCT02038907|P7|Participant Flow|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56139|NCT02038907|P6|Participant Flow|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56140|NCT02038907|P5|Participant Flow|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56141|NCT02038907|P4|Participant Flow|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56142|NCT02038907|P3|Participant Flow|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56143|NCT02038907|P2|Participant Flow|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56144|NCT02038907|P1|Participant Flow|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56145|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56146|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56147|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56148|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56149|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56150|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56151|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
98076|NCT01791725|O3|Outcome|Placebo|"Placebo BID
Placebo"
56152|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56153|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56154|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56155|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56156|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56157|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56158|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56159|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56160|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56161|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56162|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56163|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56164|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56165|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56166|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56167|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56168|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56169|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56170|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56171|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56172|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56173|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56174|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56175|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56176|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56177|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56178|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
98077|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD
ELND005"
56179|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56180|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56181|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56182|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56183|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56184|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56185|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56186|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56187|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56188|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56189|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56190|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56191|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56192|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56193|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56194|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56195|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56196|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56197|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56198|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56199|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56200|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56201|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56202|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56203|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56204|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56205|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56314|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56342|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56206|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56207|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56208|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56209|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56210|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56211|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56212|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56213|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56214|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56215|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56216|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56217|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56218|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56219|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56220|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56221|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56222|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56223|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56224|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56225|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56226|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56227|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56228|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56229|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56230|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56231|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56232|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56477|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56233|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56234|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56235|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56236|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56237|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56238|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56239|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56240|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56241|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56242|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56243|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56244|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56245|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56246|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56247|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56248|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56249|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56250|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56251|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56252|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56253|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56254|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56255|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56256|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56257|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56258|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56259|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56807|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
56260|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56261|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56262|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56263|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56264|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56265|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56266|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56267|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56268|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56269|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56270|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56271|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56272|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56273|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56274|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56275|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56276|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56277|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56278|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56279|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56280|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56281|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56282|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56283|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56284|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56285|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56286|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56808|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
56287|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56288|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56289|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56290|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56291|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56292|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56293|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56294|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56295|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56296|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56297|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56298|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56299|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56300|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56301|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56302|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56303|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56304|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56305|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56306|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56307|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56308|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56309|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56310|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56311|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56312|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56313|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56809|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
56315|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56316|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56317|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56318|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56319|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56320|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56321|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56322|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56323|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56324|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56325|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56326|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56327|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56328|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56329|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56330|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56331|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56332|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56333|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56334|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56335|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56336|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56337|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56338|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56339|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56340|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56341|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56810|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
56343|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56344|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56345|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56346|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56347|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56348|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56349|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56350|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56351|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56352|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56353|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56354|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56355|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56356|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56357|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56358|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56359|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56360|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56361|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56362|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56363|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56364|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56365|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56366|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56367|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56368|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56811|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
56369|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56370|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56371|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56372|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56373|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56374|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56375|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56376|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56377|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56378|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56379|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56380|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56381|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56382|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56383|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56384|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56385|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56386|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56387|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56388|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56389|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56390|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56391|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56392|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56393|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56394|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56395|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56812|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
56396|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56397|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56398|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56399|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56400|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56401|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56402|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56403|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56404|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56405|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56406|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56407|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56408|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56409|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56410|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56411|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56412|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56413|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56414|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56415|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56416|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56417|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56418|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56419|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56420|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56421|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56422|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56813|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
56423|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56424|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56425|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56426|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56427|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56428|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56429|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56430|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56431|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56432|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56433|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56434|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56435|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56436|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56437|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56438|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56439|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56440|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56441|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56442|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56443|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56444|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56445|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56446|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56447|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56448|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56449|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56814|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
56450|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56451|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56452|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56453|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56454|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56455|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56456|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56457|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56458|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56459|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56460|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56461|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56462|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56463|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56464|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56465|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56466|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56467|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56468|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56469|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56470|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56471|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56472|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56473|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56474|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56475|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56476|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56815|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
56478|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56479|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56480|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56481|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56482|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56483|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56484|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56485|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56486|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56487|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56488|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56489|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56490|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56491|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56492|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56493|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56494|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56495|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56496|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56497|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56498|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56499|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56500|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56501|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56502|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56503|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56504|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56816|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
56505|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56506|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56507|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56508|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56509|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56510|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56511|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56512|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56513|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56514|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56515|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56516|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56517|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56518|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56519|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56520|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56521|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56522|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56523|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56524|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56525|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56526|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56527|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56528|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56529|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56530|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56531|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56817|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
56532|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56533|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56534|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56535|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56536|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56537|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56538|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56539|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56540|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56541|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56542|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56543|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56544|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56545|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56546|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56547|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56548|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56549|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56550|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56551|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56552|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56553|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56554|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56555|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56556|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56557|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56558|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56818|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
56559|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56560|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56561|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56562|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56563|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56564|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56565|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56566|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56567|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56568|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56569|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56570|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56571|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56572|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56573|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56574|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56575|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56576|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56577|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56578|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56579|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56580|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56581|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56582|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56583|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56584|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56585|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56696|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56697|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56586|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56587|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56588|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56589|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56590|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56591|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56592|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56593|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56594|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56595|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56596|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56597|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56598|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56599|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56600|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56601|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56602|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56603|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56604|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56605|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56606|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56607|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56608|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56609|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56610|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56611|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56612|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56801|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
56613|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56614|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56615|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56616|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56617|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56618|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56619|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56620|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56621|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56622|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56623|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56624|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56625|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56626|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56627|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56628|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56629|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56630|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56631|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56632|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56633|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56634|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56635|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56636|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56637|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56638|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56639|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56802|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
56640|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56641|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56642|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56643|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56644|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56645|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56646|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56647|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56648|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56649|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56650|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56651|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56652|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56653|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56654|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56655|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56656|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56657|NCT02038907|E14|Reported Event|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56658|NCT02038907|E13|Reported Event|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56659|NCT02038907|E12|Reported Event|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
56660|NCT02038907|E11|Reported Event|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
56661|NCT02038907|E10|Reported Event|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56662|NCT02038907|E9|Reported Event|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56663|NCT02038907|E8|Reported Event|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56664|NCT02038907|E7|Reported Event|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
56665|NCT02038907|E6|Reported Event|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56666|NCT02038907|E5|Reported Event|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
56905|NCT02036541|O1|Outcome|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
56667|NCT02038907|E4|Reported Event|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56668|NCT02038907|E3|Reported Event|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56669|NCT02038907|E2|Reported Event|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
56670|NCT02038907|E1|Reported Event|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
56671|NCT02038790|B1|Baseline|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
56672|NCT02038790|P2|Participant Flow|Zubsolv - Suboxone|Participants received Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 0 and Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 1.
56673|NCT02038790|P1|Participant Flow|Suboxone - Zubsolv|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1.
56674|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56675|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56676|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56677|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56678|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56679|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56680|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56681|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56682|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56683|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56684|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56685|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56686|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56687|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56688|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56689|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56690|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56691|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56692|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56693|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56694|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56695|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
98078|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID
ELND005"
56698|NCT02038790|O1|Outcome|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
56699|NCT02038790|O1|Outcome|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
56700|NCT02038790|O1|Outcome|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
56701|NCT02038790|E2|Reported Event|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56702|NCT02038790|E1|Reported Event|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
56703|NCT02038543|B5|Baseline|Total|Total of all reporting groups
56704|NCT02038543|B4|Baseline|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified a PH types 1, 2, or 3.
56705|NCT02038543|B3|Baseline|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
56706|NCT02038543|B2|Baseline|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
56707|NCT02038543|B1|Baseline|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
56708|NCT02038543|P4|Participant Flow|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as primary hyperoxaluria (PH) types 1, 2, or 3.
56709|NCT02038543|P3|Participant Flow|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
56710|NCT02038543|P2|Participant Flow|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
56711|NCT02038543|P1|Participant Flow|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
56712|NCT02038543|O4|Outcome|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as PH types 1, 2, or 3.
56713|NCT02038543|O3|Outcome|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
56714|NCT02038543|O2|Outcome|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
56715|NCT02038543|O1|Outcome|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
56716|NCT02038543|O4|Outcome|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified as PH types 1, 2, or 3.
56717|NCT02038543|O3|Outcome|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
56718|NCT02038543|O2|Outcome|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
56719|NCT02038543|O1|Outcome|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
56720|NCT02038543|E4|Reported Event|PH Type Non 1,2,3|Subjects who presented with overproduction of oxalate, leading to recurrent kidney and bladder stones, but are not identified a PH types 1, 2, or 3.
56721|NCT02038543|E3|Reported Event|PH Type 3|In primary hyperoxaluria type 3, affected individuals often develop kidney stones in early childhood, but few cases of this type have been described so additional signs and symptoms of this type are unclear.
56722|NCT02038543|E2|Reported Event|PH Type 2|Primary hyperoxaluria type 2 is similar to type 1, but end stage renal disease (ESRD) develops later in life.
56723|NCT02038543|E1|Reported Event|PH Type 1|In primary hyperoxaluria type 1, kidney stones typically begin to appear anytime from childhood to early adulthood, and end stage renal disease (ESRD) can develop at any age.
56724|NCT02038075|B3|Baseline|Total|Total of all reporting groups
56725|NCT02038075|B2|Baseline|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.
Treatment As Usual (TAU)"
56726|NCT02038075|B1|Baseline|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
Brief Cognitive Behavioral Therapy (BCBT)"
56757|NCT02037477|B4|Baseline|Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan|Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
56727|NCT02038075|P2|Participant Flow|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.
Treatment As Usual (TAU)"
56728|NCT02038075|P1|Participant Flow|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
Brief Cognitive Behavioral Therapy (BCBT)"
56729|NCT02038075|O2|Outcome|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.
Treatment As Usual (TAU)"
56730|NCT02038075|O1|Outcome|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
Brief Cognitive Behavioral Therapy (BCBT)"
56731|NCT02038075|E2|Reported Event|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.
Treatment As Usual (TAU)"
56732|NCT02038075|E1|Reported Event|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
Brief Cognitive Behavioral Therapy (BCBT)"
56733|NCT02037776|B3|Baseline|Total|Total of all reporting groups
56734|NCT02037776|B2|Baseline|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
56735|NCT02037776|B1|Baseline|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
56736|NCT02037776|P2|Participant Flow|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
56737|NCT02037776|P1|Participant Flow|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
56738|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
56739|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
56740|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
56741|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
56742|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
56743|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
56744|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
56745|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
56746|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
56747|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
56748|NCT02037776|O2|Outcome|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
56749|NCT02037776|O1|Outcome|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
56750|NCT02037776|E2|Reported Event|Rikkunshito|Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
56751|NCT02037776|E1|Reported Event|Rikkunshito Placebo|Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
56752|NCT02037607|B1|Baseline|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound within 48 hours prior to surgery and a repeat within 72 hours after surgery.
56753|NCT02037607|P1|Participant Flow|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
56754|NCT02037607|O1|Outcome|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
56755|NCT02037607|E1|Reported Event|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
56756|NCT02037477|B5|Baseline|Total|Total of all reporting groups
56758|NCT02037477|B3|Baseline|Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium|Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then rabeprazole sodium 10 mg, orally, once daily for 7 days.
56759|NCT02037477|B2|Baseline|Sequence B (Cohort 1): Esomeprazole + Vonoprazan|Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
56760|NCT02037477|B1|Baseline|Sequence A (Cohort 1): Vonoprazan + Esomeprazole|Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then esomeprazole 20 mg, orally, once daily for 7 days.
56761|NCT02037477|P4|Participant Flow|Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan|Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
56762|NCT02037477|P3|Participant Flow|Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium|Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then rabeprazole sodium 10 mg, orally, once daily for 7 days.
56763|NCT02037477|P2|Participant Flow|Sequence B (Cohort 1): Esomeprazole + Vonoprazan|Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
56764|NCT02037477|P1|Participant Flow|Sequence A (Cohort 1): Vonoprazan + Esomeprazole|Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then esomeprazole 20 mg, orally, once daily for 7 days.
56765|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
56766|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56767|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
56768|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56769|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
56770|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56771|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
56772|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56773|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
56774|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56775|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
56776|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56777|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
56778|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56779|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
56780|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56781|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
56782|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56783|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
56784|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56785|NCT02037477|E4|Reported Event|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
56786|NCT02037477|E3|Reported Event|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56787|NCT02037477|E2|Reported Event|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
56788|NCT02037477|E1|Reported Event|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
56789|NCT02037425|B1|Baseline|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days). A total of 30 subjects were used in data analysis as 2 subjects did not complete any outcome measures once enrolled in the study.
56790|NCT02037425|P1|Participant Flow|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
56791|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
56792|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
56793|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
56794|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
56795|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
56796|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
56797|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
56798|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
56799|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
56800|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
56819|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
56820|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
56826|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
56827|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
56828|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
56829|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
56830|NCT02037425|E1|Reported Event|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
56831|NCT02037347|B1|Baseline|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
56832|NCT02037347|P1|Participant Flow|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
56833|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
56834|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
56835|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
56836|NCT02037347|E1|Reported Event|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
56837|NCT02036840|B1|Baseline|Penicillin Allergy|Antibiotic
56838|NCT02036840|P1|Participant Flow|Penicillin Allergy|Antibiotic
56839|NCT02036840|O1|Outcome|Penicillin Allergy|Antibiotic
56840|NCT02036840|E1|Reported Event|Penicillin Allergy|Antibiotic
56841|NCT02036775|B1|Baseline|Study Overall|"A randomised, open-label, three period, crossover study. The three treatments administered were:
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
Each subject received one treatment per treatment period. Each of the three treatment phases was 6 days long, where study drug was administered on day 1-5 during each treatment."
56842|NCT02036775|P6|Participant Flow|Lasolvan 75mg / Lasolvan 60mg / Lasolvan 30mg|"Patients were administered three treatments in the following order:
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)"
56843|NCT02036775|P5|Participant Flow|Lasolvan 30mg / Lasolvan 75mg / Lasolvan 60mg|"Patients were administered three treatments in the following order:
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days"
56844|NCT02036775|P4|Participant Flow|Lasolvan 60mg / Lasolvan 30mg / Lasolvan 75mg|"Patients were administered three treatments in the following order:
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days"
56845|NCT02036775|P3|Participant Flow|Lasolvan 30mg / Lasolvan 60mg / Lasolvan 75mg|"Patients were administered three treatments in the following order:
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days"
56846|NCT02036775|P2|Participant Flow|Lasolvan 60mg / Lasolvan 75mg / Lasolvan 30mg|"Patients were administered three treatments in the following order:
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)"
56847|NCT02036775|P1|Participant Flow|Lasolvan 75mg / Lasolvan 30mg / Lasolvan 60mg|"Patients were administered three treatments in the following order:
One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days"
56848|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56849|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56850|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56851|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56852|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56853|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56854|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56855|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56856|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56857|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56858|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56917|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56859|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56860|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56861|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56862|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56863|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56864|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56865|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56866|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56867|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56868|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56869|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56870|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56871|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56872|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56873|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56874|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56875|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56876|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56877|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56878|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56879|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56880|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56881|NCT02036775|E3|Reported Event|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
56882|NCT02036775|E2|Reported Event|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
56883|NCT02036775|E1|Reported Event|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
56884|NCT02036580|B4|Baseline|Total|Total of all reporting groups
56885|NCT02036580|B3|Baseline|Placebo|Placebo Q4W intravenously dosed for 24 weeks
56886|NCT02036580|B2|Baseline|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
56887|NCT02036580|B1|Baseline|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
56888|NCT02036580|P3|Participant Flow|Placebo|Placebo Q4W intravenously dosed for 24 weeks
56889|NCT02036580|P2|Participant Flow|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
56890|NCT02036580|P1|Participant Flow|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
56891|NCT02036580|O3|Outcome|Placebo|Placebo Q4W intravenously dosed for 24 weeks
56892|NCT02036580|O2|Outcome|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
56893|NCT02036580|O1|Outcome|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
56894|NCT02036580|O2|Outcome|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
56895|NCT02036580|O1|Outcome|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
56896|NCT02036580|O3|Outcome|Placebo|Placebo Q4W intravenously dosed for 24 weeks
56897|NCT02036580|O2|Outcome|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
56898|NCT02036580|O1|Outcome|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
56899|NCT02036580|E3|Reported Event|Placebo|Placebo Q4W intravenously dosed for 24 weeks
56900|NCT02036580|E2|Reported Event|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
56901|NCT02036580|E1|Reported Event|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
56902|NCT02036541|B1|Baseline|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
56903|NCT02036541|P1|Participant Flow|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
56904|NCT02036541|O1|Outcome|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
56911|NCT02036515|P3|Participant Flow|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56912|NCT02036515|P2|Participant Flow|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56913|NCT02036515|P1|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56914|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56915|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56916|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
89788|NCT01843374|O2|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
56924|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56925|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56926|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56927|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56928|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56929|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56930|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56931|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56932|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56933|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56934|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56935|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56936|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56937|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56938|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56939|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56940|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56941|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56942|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56943|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56944|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56945|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56946|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56947|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56948|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56949|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56950|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56951|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56952|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56953|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56954|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56955|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56956|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56957|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56958|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56959|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56960|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56961|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56962|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56963|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56964|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56965|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56966|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56967|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56968|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56969|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56970|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56971|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56974|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56975|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56976|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56977|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56978|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56979|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56980|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56981|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56982|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56983|NCT02036515|O3|Outcome|Placebo|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
56984|NCT02036515|O2|Outcome|Ertugliflozin 15 mg|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56985|NCT02036515|O1|Outcome|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56986|NCT02036515|E3|Reported Event|Placebo (Phase A+B)|Matching placebo to ertuglifozin, oral, once daily for 52 weeks
89789|NCT01843374|O1|Outcome|PLACEBO|Placebo.
56987|NCT02036515|E2|Reported Event|Ertugliflozin 15 mg (Phase A+B)|Ertugliflozin, 15 mg, oral, once daily for 52 weeks
56988|NCT02036515|E1|Reported Event|Ertugliflozin 5 mg (Phase A+B)|Ertugliflozin, 5 mg, oral, once daily for 52 weeks
56989|NCT02036424|B3|Baseline|Total|Total of all reporting groups
56990|NCT02036424|B2|Baseline|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid"
56991|NCT02036424|B1|Baseline|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF"
56992|NCT02036424|P2|Participant Flow|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid"
56993|NCT02036424|P1|Participant Flow|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF"
56994|NCT02036424|O2|Outcome|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid"
56995|NCT02036424|O1|Outcome|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF"
56996|NCT02036424|O2|Outcome|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid"
56997|NCT02036424|O1|Outcome|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF"
56998|NCT02036424|E2|Reported Event|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid"
56999|NCT02036424|E1|Reported Event|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF"
57000|NCT02036320|B1|Baseline|Overall|All subjects that were dispensed a test article during the study.
57001|NCT02036320|P2|Participant Flow|Test 2/Test 1|Subjects who received test lens 2 first and then received test lens 1.
57002|NCT02036320|P1|Participant Flow|Test 1/Test 2|Subjects who received test lens 1 first and then received test lens 2.
57003|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
57004|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
57005|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
57006|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
57007|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
57008|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
57009|NCT02036320|E2|Reported Event|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
57010|NCT02036320|E1|Reported Event|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
57011|NCT02035748|B1|Baseline|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
57012|NCT02035748|P1|Participant Flow|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
57013|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
57014|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
57015|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
57016|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
57017|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
57018|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
57019|NCT02035748|E2|Reported Event|Ocriplasmin|All subjects exposed to the investigational product
57020|NCT02035748|E1|Reported Event|Pretreatment|All subjects consented to participate in the study prior to the initiation of study treatment
57021|NCT02035696|B5|Baseline|Total|Total of all reporting groups
57022|NCT02035696|B4|Baseline|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
57023|NCT02035696|B3|Baseline|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
57024|NCT02035696|B2|Baseline|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
57025|NCT02035696|B1|Baseline|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
57026|NCT02035696|P4|Participant Flow|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
57027|NCT02035696|P3|Participant Flow|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
57028|NCT02035696|P2|Participant Flow|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
57029|NCT02035696|P1|Participant Flow|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
57030|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
57031|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
57032|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
57033|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
57034|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
57035|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
57036|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
57037|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
57038|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
57039|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
57040|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
57041|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
57042|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
57043|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
57044|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
57045|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
57046|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
57047|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
57048|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
57049|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
57050|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
57051|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
57052|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
57053|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
57054|NCT02035696|O3|Outcome|TIVc- Half Dose-TIVe|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
57055|NCT02035696|O2|Outcome|TIVc-Full Dose-TIVe|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
57056|NCT02035696|O1|Outcome|TIVc-High Dose-TIVe|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
57057|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
57058|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
57059|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
57060|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
57061|NCT02035696|O4|Outcome|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
57062|NCT02035696|O3|Outcome|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
57063|NCT02035696|O2|Outcome|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
57064|NCT02035696|O1|Outcome|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
57065|NCT02035696|E5|Reported Event|Total|Total number of subjects
57066|NCT02035696|E4|Reported Event|TIVe|Subjects (6 to <48 months old) received two doses of TIVe vaccine
57067|NCT02035696|E3|Reported Event|TIVc- Half Dose|Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
57068|NCT02035696|E2|Reported Event|TIVc-Full Dose|Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
57069|NCT02035696|E1|Reported Event|TIVc-High Dose|Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
57070|NCT02035475|B1|Baseline|Intuitive Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
57071|NCT02035475|P1|Participant Flow|Intuitive Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
57072|NCT02035475|O1|Outcome|Study Participants|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
57073|NCT02035475|O2|Outcome|Fenestrated Maryland BiPolar Instrument|The Fenestrated Maryland BiPolar Instrument was utilized on one side of the body, with each participant receiving both treatments, one each side.
57074|NCT02035475|O1|Outcome|EndoWrist 1 Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
The EndoWrist 1 Vessel Sealer was utilized on one side of the body, with each participant receiving both treatments, one each side."
57075|NCT02035475|E1|Reported Event|Study Participants|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
57076|NCT02035345|B1|Baseline|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:
First hour - Administer 1 percent of total dose (5ml with tubing primed)
Second hour - Administer 9 percent (45 mL)
Third hour - Administer 90 percent (450 mL)
Carboplatin"
57077|NCT02035345|P1|Participant Flow|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:
First hour - Administer 1 percent of total dose (5ml with tubing primed)
Second hour - Administer 9 percent (45 mL)
Third hour - Administer 90 percent (450 mL)
Carboplatin"
57078|NCT02035345|O1|Outcome|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:
First hour - Administer 1 percent of total dose (5ml with tubing primed)
Second hour - Administer 9 percent (45 mL)
Third hour - Administer 90 percent (450 mL)
Carboplatin"
57117|NCT02034708|E3|Reported Event|Total|Patients who received at least one injection of contrast agent
57079|NCT02035345|O1|Outcome|Carboplain Slowed Infusion Group Reactors|Patients that received carboplatin via slowed infusion that developed a reaction
57080|NCT02035345|E1|Reported Event|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:
First hour - Administer 1 percent of total dose (5ml with tubing primed)
Second hour - Administer 9 percent (45 mL)
Third hour - Administer 90 percent (450 mL)
Carboplatin"
57081|NCT02035332|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
57082|NCT02035332|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
57083|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
57084|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
57085|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
57086|NCT02035332|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
57087|NCT02034877|B3|Baseline|Total|Total of all reporting groups
57088|NCT02034877|B2|Baseline|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
57089|NCT02034877|B1|Baseline|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
57090|NCT02034877|P2|Participant Flow|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
57091|NCT02034877|P1|Participant Flow|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
57092|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
57093|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
57094|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
57095|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
57096|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
57097|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
57098|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
57099|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
57100|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
57101|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
57102|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
57103|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
57104|NCT02034877|E2|Reported Event|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
57105|NCT02034877|E1|Reported Event|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
57106|NCT02034708|B3|Baseline|Total|Total of all reporting groups
57107|NCT02034708|B2|Baseline|Gadovist®/Dotarem®|"Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI
Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
58445|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
57108|NCT02034708|B1|Baseline|Dotarem®/Gadovist®|"Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI
Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
57109|NCT02034708|P2|Participant Flow|Gadovist®/Dotarem®|"Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI
Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
57110|NCT02034708|P1|Participant Flow|Dotarem®/Gadovist®|"Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI
Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
57111|NCT02034708|O6|Outcome|Dotarem® (Reader 3)|Patients who received Dotarem® Results for reader 3
57112|NCT02034708|O5|Outcome|Gadovist® (Reader 3)|Patients who received Gadovist® Results for reader 3
57113|NCT02034708|O4|Outcome|Dotarem® (Reader 2)|Patients who received Dotarem® Results for reader 2
57114|NCT02034708|O3|Outcome|Gadovist® (Reader 2)|Patients who received Gadovist® Results for reader 2
57115|NCT02034708|O2|Outcome|Dotarem® (Reader 1)|Patients who received Dotarem® Results for reader 1
57116|NCT02034708|O1|Outcome|Gadovist® (Reader 1)|Patients who received Gadovist® Results for reader 1
57118|NCT02034708|E2|Reported Event|Gadovist®|Patients who received Gadovist®
57119|NCT02034708|E1|Reported Event|Dotarem®|Patients who received Dotarem®
57120|NCT02034591|B1|Baseline|All Treatment Groups|All Randomized Participants
57121|NCT02034591|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|"Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
57122|NCT02034591|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|"Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
57123|NCT02034591|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|"Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
57124|NCT02034591|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|"Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
57125|NCT02034591|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|"Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
57126|NCT02034591|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|"Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
57127|NCT02034591|O3|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
57128|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
57129|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
57130|NCT02034591|O3|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
57131|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
57132|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
57133|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
57134|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
57135|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
57136|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
57137|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
57138|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
57139|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
57140|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
57141|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
57142|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
57143|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
57144|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
57145|NCT02034591|E3|Reported Event|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
57146|NCT02034591|E2|Reported Event|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
57147|NCT02034591|E1|Reported Event|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
57148|NCT02034578|B1|Baseline|5mg Apixaban|After a 10 hour fast, participants were randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB or CBA) administered over 3 periods. Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. Treatment A was administered via oral syringe, Treatment B was administered via an NGT followed by 60 mL of D5W via an NGT, and Treatment C was administered via an NGT, followed by 60 mL of infant formula via an NGT. There was at least a 4 day washout before receiving the next scheduled treatment in the next period.
57149|NCT02034578|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.
Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.
Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.
After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
57150|NCT02034578|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.
Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.
Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.
After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
57151|NCT02034578|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.
Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.
Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.
After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
57152|NCT02034578|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.
Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.
Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.
After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
58106|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
57153|NCT02034578|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.
Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.
Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.
After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
57184|NCT02034565|O1|Outcome|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
57185|NCT02034565|O2|Outcome|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
57186|NCT02034565|O1|Outcome|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
57187|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
61576|NCT02005692|B1|Baseline|DynaSense Sensor|All subjects who successfully completed the study.
57154|NCT02034578|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.
Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.
Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.
After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
57155|NCT02034578|O1|Outcome|5mg Apixaban|After a 10 hour fast, participants were randomized on Day 1 of Period 1 to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB or CBA) and received a single dose of apixaban 5 mg. Treatment A was administered via oral syringe, Treatment B was administered via an NGT followed by 60 mL of D5W via an NGT, and Treatment C was administered via an NGT, followed by 60 mL of infant formula via an NGT. There was at least a 4 day washout before receiving the next scheduled treatment in Period 2 and Period 3.
57156|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
57157|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
57158|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
57159|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
57160|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
57161|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
57162|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
57163|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
57164|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
57165|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
57166|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
57167|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
57168|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
57169|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
57170|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
57171|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
57172|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
57173|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
57174|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
57175|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
57176|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
57177|NCT02034578|E3|Reported Event|5 mg Apixaban Via NGT Followed by Infant Formula (C)|In Treatment C, the single dose of 5 mg apixaban was administered via NGT, followed by 60 mL of infant formula via the NGT.
57178|NCT02034578|E2|Reported Event|5mg Apixaban Via NGT Followed by D5W (B)|In Treatment B the single dose of 5 mg apixaban was administered via nasogastric tube (NGT) followed by 60 mL of dextrose, water (D5W) via the NGT.
57179|NCT02034578|E1|Reported Event|5mg Apixaban Via Oral Syringe (A)|"After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences administered over 3 Periods (ABC, ACB, BAC, BCA, CAB or CBA) and received a single dose of apixaban 5 mg. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3.
In Treatment A the single dose of 5 mg apixaban was administered via oral syringe."
57180|NCT02034565|B1|Baseline|All Treatment Groups|All Randomized Participants
57778|NCT02029911|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
57181|NCT02034565|P2|Participant Flow|Treatment B, Then Treatment A|"Each participant was given two interventions, one per period, with a 4 day washout in between periods.
Treatment A: Single dose apixaban film-coated tablet, 10 milligrams (mg) via 2 x 5 mg tablets, administered orally
Treatment B: Single dose apixaban solution, 10 milligrams (mg) via 25 milliliters (mL) x 0.4 mg/mL, administered orally"
57182|NCT02034565|P1|Participant Flow|Treatment A, Then Treatment B|"Each participant was given two interventions, one per period, with a 4 day washout in between periods.
Treatment A: Single dose apixaban film-coated tablet, 10 milligrams (mg) via 2 x 5 mg tablets, administered orally
Treatment B: Single dose apixaban solution, 10 milligrams (mg) via 25 milliliters (mL) x 0.4 mg/mL, administered orally"
57183|NCT02034565|O2|Outcome|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
57188|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
57189|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
57190|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
57191|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
57192|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
57193|NCT02034565|E2|Reported Event|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
57194|NCT02034565|E1|Reported Event|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
57195|NCT02034552|B4|Baseline|Total|Total of all reporting groups
57196|NCT02034552|B3|Baseline|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57197|NCT02034552|B2|Baseline|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57198|NCT02034552|B1|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
57199|NCT02034552|P3|Participant Flow|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57200|NCT02034552|P2|Participant Flow|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57201|NCT02034552|P1|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
57202|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57203|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57204|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
57205|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57206|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57207|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
57208|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57209|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57779|NCT02029846|B3|Baseline|Total|Total of all reporting groups
57210|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
57211|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57212|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57213|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
57251|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
57214|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57215|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57216|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
57217|NCT02034552|O3|Outcome|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57218|NCT02034552|O2|Outcome|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57219|NCT02034552|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
57220|NCT02034552|E3|Reported Event|Radium-223 With Enzalutamide|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus) and enzalutamide 160 mg daily (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57221|NCT02034552|E2|Reported Event|Radium-223 With Abiraterone & Prednision|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks x 6 doses (IV slow bolus), abiraterone acetate 1000 mg daily, and prednisone 5 mg bid (oral). The first dose of oral co-medications is to be given after the first radium-223 dichloride injection.
57222|NCT02034552|E1|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of National Institute of Standards and Technology (NIST) update) every 4 weeks x 6 doses IV (slow bolus).
57223|NCT02034513|B3|Baseline|Total|Total of all reporting groups
57224|NCT02034513|B2|Baseline|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57225|NCT02034513|B1|Baseline|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
57226|NCT02034513|P2|Participant Flow|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57246|NCT02034162|P2|Participant Flow|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
58446|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
57227|NCT02034513|P1|Participant Flow|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received insulin degludec (IDeg) in treatment period 1 and insulin glargine (IGlar) in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered subcutaneously (s.c.; under the skin) in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken once daily (OD) at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast self measured plasma glucose(SMPG) values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L)
57252|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
57228|NCT02034513|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57229|NCT02034513|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
57230|NCT02034513|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57231|NCT02034513|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
57232|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57233|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57234|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57235|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57298|NCT02033200|B3|Baseline|Total|Total of all reporting groups
57236|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57237|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57238|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57239|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57240|NCT02034513|E2|Reported Event|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57241|NCT02034513|E1|Reported Event|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
57242|NCT02034162|B3|Baseline|Total|Total of all reporting groups
57243|NCT02034162|B2|Baseline|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57244|NCT02034162|B1|Baseline|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57245|NCT02034162|P3|Participant Flow|Open-label Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
58107|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
57247|NCT02034162|P1|Participant Flow|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57248|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
57249|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
57250|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
57253|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
57254|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
57255|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
57256|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
57257|NCT02034162|O1|Outcome|Open-label Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
57258|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
57259|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
57260|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
57261|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57262|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57263|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57264|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57265|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57266|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57267|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57268|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57269|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57270|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57271|NCT02034162|E3|Reported Event|OL Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
57272|NCT02034162|E2|Reported Event|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57273|NCT02034162|E1|Reported Event|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
57274|NCT02033317|B1|Baseline|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
57275|NCT02033317|P1|Participant Flow|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
57276|NCT02033317|O1|Outcome|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
57277|NCT02033317|O1|Outcome|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
57278|NCT02033317|E1|Reported Event|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally.
57279|NCT02033213|B3|Baseline|Total|Total of all reporting groups
57359|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
98079|NCT01791725|O3|Outcome|Placebo|"Placebo BID
Placebo"
57280|NCT02033213|B2|Baseline|Liberal Group|"Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57281|NCT02033213|B1|Baseline|Restrictive Group|"Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57282|NCT02033213|P2|Participant Flow|Liberal Group|"Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57299|NCT02033200|B2|Baseline|Placebo|placebo
57300|NCT02033200|B1|Baseline|Active|Stendra 200 mg
57283|NCT02033213|P1|Participant Flow|Restrictive Group|"Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57284|NCT02033213|O2|Outcome|Liberal Group|"Patients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.
Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57285|NCT02033213|O1|Outcome|Restrictive Group|"Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.
Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57286|NCT02033213|O2|Outcome|Liberal Group|"Patients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.
Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57287|NCT02033213|O1|Outcome|Restrictive Group|"Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.
Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57288|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57289|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57290|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57291|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57292|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57293|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57294|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57360|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
57295|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57296|NCT02033213|E2|Reported Event|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57297|NCT02033213|E1|Reported Event|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
57321|NCT02033174|B1|Baseline|All Participants|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
57322|NCT02033174|P2|Participant Flow|Sugar Water First ,Then Alcohol|Participants first received an oral fat-enriched diet (1486 kcal/m2) and sugar with water for 5 days. They then received a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) for 5 days.
57323|NCT02033174|P1|Participant Flow|Alcohol First, Then Sugar Water|Participants first received an oral fat-enriched diet (1486 kcal/m2) and a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) for 5 days. Then, they received equivalent caloric intakes as sugar with water in the control group for 5 days.
57324|NCT02033174|O2|Outcome|Oral Fat Diet|The fat-enriched diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
57325|NCT02033174|O1|Outcome|Alcoholic Beverages (Red Wine Intake)|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine
57326|NCT02033174|E2|Reported Event|Oral Fat Diet|Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
57327|NCT02033174|E1|Reported Event|Alcoholic Beverages|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
57328|NCT02032901|B3|Baseline|Total|Total of all reporting groups
57329|NCT02032901|B2|Baseline|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57330|NCT02032901|B1|Baseline|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57331|NCT02032901|P2|Participant Flow|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57332|NCT02032901|P1|Participant Flow|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57333|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57334|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57335|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57336|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57337|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57338|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57339|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57340|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57341|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57342|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57343|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57344|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57345|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57346|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57347|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57348|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57349|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57350|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
57351|NCT02032901|E1|Reported Event|Daclatasvir + Sofosbuvir|All participants infected with hepatitis C virus (HCV) genotype-3 received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks during the study.
57352|NCT02032888|B4|Baseline|Total|Total of all reporting groups
57353|NCT02032888|B3|Baseline|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
57354|NCT02032888|B2|Baseline|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
57355|NCT02032888|B1|Baseline|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
57356|NCT02032888|P3|Participant Flow|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
57357|NCT02032888|P2|Participant Flow|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
57358|NCT02032888|P1|Participant Flow|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV)treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily, for 12 weeks of treatment and 24 weeks of follow-up.
57460|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
57361|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
57362|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
57363|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
57364|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
57365|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
57366|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
57367|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
57368|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvi,r 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
57369|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
57370|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
57371|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
89790|NCT01843374|O2|Outcome|PLACEBO|Placebo.
57372|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
57373|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
57374|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
57375|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
57376|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
57377|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
57378|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
57379|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV)treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
57380|NCT02032888|O1|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
57381|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
57382|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
57383|NCT02032888|E3|Reported Event|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
57384|NCT02032888|E2|Reported Event|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
57385|NCT02032888|E1|Reported Event|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
57386|NCT02032875|B3|Baseline|Total|Total of all reporting groups
57387|NCT02032875|B2|Baseline|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57388|NCT02032875|B1|Baseline|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57461|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
57389|NCT02032875|P2|Participant Flow|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57390|NCT02032875|P1|Participant Flow|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57391|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57392|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57393|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57394|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57395|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57419|NCT02032706|P1|Participant Flow|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57396|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57397|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57398|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57399|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57400|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57401|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57402|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57403|NCT02032875|O1|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57404|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57405|NCT02032875|E2|Reported Event|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57406|NCT02032875|E1|Reported Event|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
57407|NCT02032758|B3|Baseline|Total|Total of all reporting groups
57408|NCT02032758|B2|Baseline|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
57409|NCT02032758|B1|Baseline|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
57462|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
57410|NCT02032758|P2|Participant Flow|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
57411|NCT02032758|P1|Participant Flow|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
57412|NCT02032758|O2|Outcome|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
57413|NCT02032758|O1|Outcome|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
57414|NCT02032758|O2|Outcome|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
57415|NCT02032758|O1|Outcome|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
57416|NCT02032758|E2|Reported Event|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
57417|NCT02032758|E1|Reported Event|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
57418|NCT02032706|B1|Baseline|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57420|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57421|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57422|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57423|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57424|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57425|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57426|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57427|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57428|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57429|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57430|NCT02032706|E1|Reported Event|Positional Feedback|"Deliver therapy when the supine position is detected
Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
57431|NCT02032641|B1|Baseline|Laser Treatment and Control Group|"Each patient was randomized to have one of two scars treated with Laser Genesis and a scar not treated with Laser Genesis, which was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study. The laser treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage.
Laser treatment: Non-ablative, non-fractional, microsecond-pulsed Neodymium:Yttrium/Aluminum/Garnet laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size"
57463|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
57464|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
57465|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
57466|NCT02032407|E1|Reported Event|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
57467|NCT02032238|B3|Baseline|Total|Total of all reporting groups
57468|NCT02032238|B2|Baseline|Monotherapy|"patients receive Anti-VEGF Monotherapy
Anti-VEGF Injections: Monotherapy"
98080|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD
ELND005"
57432|NCT02032641|P1|Participant Flow|Laser Treatment and Control Group|"Each patient was randomized to have one of two scars treated with Laser Genesis and a scar not treated with Laser Genesis, which was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study. The laser treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage.
Laser treatment: Non-ablative, non-fractional, microsecond-pulsed Neodymium:Yttrium/Aluminum/Garnet laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size"
57433|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
57434|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
57435|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
57436|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
89791|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
57437|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
57438|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
57439|NCT02032641|E2|Reported Event|Laser Left, Non-laser RIght|Group which had the right post-operative scar assigned to receive laser treatment
57440|NCT02032641|E1|Reported Event|Laser Right, Non-laser Left|Group which had the right post-operative scar assigned to receive laser treatment
57441|NCT02032420|B3|Baseline|Total|Total of all reporting groups
57442|NCT02032420|B2|Baseline|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
57443|NCT02032420|B1|Baseline|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
57444|NCT02032420|P2|Participant Flow|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
57445|NCT02032420|P1|Participant Flow|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
57446|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
57447|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
57448|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
57449|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
57450|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
57451|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
57452|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
57453|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
57454|NCT02032420|E2|Reported Event|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
57455|NCT02032420|E1|Reported Event|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
57456|NCT02032407|B1|Baseline|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
57457|NCT02032407|P1|Participant Flow|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
57458|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
57459|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
57469|NCT02032238|B1|Baseline|Combination With Navigated Laser|"Combining photocoagulation and Anti-VEGF Injections in a pre-defined manner
Navigated laser: Standard Anti-VEGF Injections will be combined with Navigated laser in a pre-defined manner
Anti-VEGF Injections: Monotherapy"
57470|NCT02032238|P2|Participant Flow|Bevacizumab, no Laser Photocoagulation|patients receive Anti-VEGF injections (Bevacizumab) only
57471|NCT02032238|P1|Participant Flow|Laser Photocoagulation With Bevacizumab|Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner
57472|NCT02032238|O2|Outcome|Monotherapy|"patients receive Anti-VEGF Monotherapy
Anti-VEGF Injections: Monotherapy"
57473|NCT02032238|O1|Outcome|Combination With Navigated Laser|"Combining photocoagulation and Anti-VEGF Injections in a pre-defined manner
Navigated laser: Standard Anti-VEGF Injections will be combined with Navigated laser in a pre-defined manner
Anti-VEGF Injections: Monotherapy"
57474|NCT02032238|E2|Reported Event|Bevacizumab, no Laser Photocoagulation|patients receive Anti-VEGF injections (Bevacizumab) only
57475|NCT02032238|E1|Reported Event|Laser Photocoagulation With Bevacizumab|Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner
57476|NCT02032212|B5|Baseline|Total|Total of all reporting groups
57477|NCT02032212|B4|Baseline|Sequence 4|Subjects in this arm used the conventional cigarette on Day 1, the Nicotine inhalator on Day 2, the flavoured EVP on Day 3, the unflavoured EVP on Day 4.
57478|NCT02032212|B3|Baseline|Sequence 3|Subjects in this arm used the Nicotine inhalator on Day 1 and the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
57479|NCT02032212|B2|Baseline|Sequence 2|Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the Nicotine inhalator on Day 4.
57480|NCT02032212|B1|Baseline|Sequence 1|Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
57481|NCT02032212|P4|Participant Flow|Sequence 4|Subjects in this arm used the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.
57482|NCT02032212|P3|Participant Flow|Sequence 3|Subjects in this arm used the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
57483|NCT02032212|P2|Participant Flow|Sequence 2|Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.
57484|NCT02032212|P1|Participant Flow|Sequence 1|Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
57485|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
57486|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
57487|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
57488|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
57489|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
57490|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
57491|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
57492|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
57493|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
57494|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
57495|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
57496|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
57497|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
57498|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
57499|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
57500|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
57501|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
57502|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
57503|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
57504|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
57505|NCT02032212|E4|Reported Event|Conventional Cigarette|Conventional cigarette (commercially available)
57506|NCT02032212|E3|Reported Event|Nicotine Inhalator|Nicotine inhalator 15mg
57507|NCT02032212|E2|Reported Event|EVP Flavoured|Flavoured e-vapour product
57508|NCT02032212|E1|Reported Event|EVP Unflavoured|Unflavoured e-vapour product
57509|NCT02031679|B3|Baseline|Total|Total of all reporting groups
57510|NCT02031679|B2|Baseline|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.
The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
57511|NCT02031679|B1|Baseline|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.
The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
57512|NCT02031679|P2|Participant Flow|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.
The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
57529|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57513|NCT02031679|P1|Participant Flow|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.
The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
57514|NCT02031679|O2|Outcome|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.
The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
57515|NCT02031679|O1|Outcome|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.
The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
57516|NCT02031679|O2|Outcome|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.
The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
57517|NCT02031679|O1|Outcome|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.
The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
57787|NCT02029846|O1|Outcome|Standard Treatment|"A regimen with traditional drugs only
Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
57518|NCT02031679|O2|Outcome|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.
The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
57519|NCT02031679|O1|Outcome|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.
The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
57520|NCT02031679|E2|Reported Event|Placebo|"The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound.
The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
Placebo: Sugar pill manufactured to mimic AZD1981 10 mg tablet"
57521|NCT02031679|E1|Reported Event|AZD1981|"AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths.
The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening.
The tablets should be swallowed whole with a glass of water.
AZD1981: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells)."
57522|NCT02031471|B1|Baseline|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57523|NCT02031471|P1|Participant Flow|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the long term extension (LTE) period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. Participants entered 8 weeks of follow-up either at the end of the 24-week open-label core study or after completion of the LTE. A fixed dose of 162 milligram (mg) tocilizumab was administered subcutaneously once weekly.
57524|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57525|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57526|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57527|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57528|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57530|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57531|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57532|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57533|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57534|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57535|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57536|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57537|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57538|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57539|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57540|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57541|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57542|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57543|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57544|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57545|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57546|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57547|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
58108|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
57548|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57549|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57550|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
57551|NCT02031471|E1|Reported Event|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the long term extension (LTE) period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 milligram (mg) tocilizumab was administered subcutaneously once weekly.
57552|NCT02031458|B4|Baseline|Total|Total of all reporting groups
57591|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57592|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
63656|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select VFI variables
57553|NCT02031458|B3|Baseline|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57554|NCT02031458|B2|Baseline|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57555|NCT02031458|B1|Baseline|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57556|NCT02031458|P3|Participant Flow|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57557|NCT02031458|P2|Participant Flow|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in Eastern Cooperative Oncology Group (ECOG) performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57558|NCT02031458|P1|Participant Flow|Cohort 1: First Line Atezolizumab|Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57559|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57560|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57561|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57562|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57563|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57564|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57631|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
89792|NCT01843374|O2|Outcome|PLACEBO|Placebo.
57565|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57566|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57567|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57568|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57569|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57570|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57571|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57572|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57573|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57574|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57575|NCT02031458|O1|Outcome|Pharmacokinetic Evaluable Population|Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57576|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
58109|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
57577|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57632|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57788|NCT02029846|O2|Outcome|Incretin-based Treatment|"A regimen including incretin-based drugs
Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
58121|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
57578|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57579|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57580|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57581|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57582|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57583|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57584|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57585|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57586|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57587|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57588|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57589|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57729|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations (a.m. dosing) via RESPIMAT® inhaler"
57590|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57593|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57594|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57595|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57596|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57597|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57598|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57599|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57600|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57601|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57602|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57730|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
58447|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
57603|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57604|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57605|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57606|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57607|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57608|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57609|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57610|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57611|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57612|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57613|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57614|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57615|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57616|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57643|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
58110|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
57617|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57701|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57789|NCT02029846|O1|Outcome|Standard Treatment|"A regimen with traditional drugs only
Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
57618|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57619|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57620|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57621|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57622|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57623|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57624|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57625|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57626|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57627|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57628|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57629|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57644|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57630|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57633|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57634|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57635|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57636|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57637|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57638|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57639|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57640|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
57641|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57642|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57776|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
98081|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID
ELND005"
57645|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57702|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57703|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
63657|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select VFI variables
57646|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57647|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57648|NCT02031458|E3|Reported Event|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
57649|NCT02031458|E2|Reported Event|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
57650|NCT02031458|E1|Reported Event|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
57651|NCT02030600|B3|Baseline|Total|Total of all reporting groups
57652|NCT02030600|B2|Baseline|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57653|NCT02030600|B1|Baseline|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57654|NCT02030600|P2|Participant Flow|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57692|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57693|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57694|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57704|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57705|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57706|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57655|NCT02030600|P1|Participant Flow|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received insulin degludec (IDeg) in treatment period 1 and insulin glargine (IGlar) in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting self-measured plasma glucose (SMPG) values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57656|NCT02030600|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57657|NCT02030600|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57658|NCT02030600|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57659|NCT02030600|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57660|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57661|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57695|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57696|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57697|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
58448|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
57662|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57663|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57664|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57665|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57666|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57667|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57668|NCT02030600|E2|Reported Event|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57698|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57699|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57700|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
98082|NCT01791725|E3|Reported Event|Placebo|"Placebo BID
Placebo"
57669|NCT02030600|E1|Reported Event|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
57670|NCT02030574|B1|Baseline|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.
GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
57671|NCT02030574|P1|Participant Flow|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.
GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
57672|NCT02030574|O1|Outcome|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.
GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
57673|NCT02030574|O1|Outcome|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.
GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
57674|NCT02030574|E1|Reported Event|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.
GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
57675|NCT02030535|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study.
57676|NCT02030535|P1|Participant Flow|Overall Study|Total number of patients randomised and treated in the study. (This is a cross-over trial consisting of a minimum two-week screening period. After screening, eligible patients were randomly assigned to one of 12 treatment sequences. Each patient received all three treatments as single doses on the three test days. Between test days with single dose administration there are 3-week washout periods.)
57677|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57678|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57679|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57680|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57681|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57682|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57683|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57684|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57685|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57686|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57687|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57688|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57689|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination) Olodaterol: 5 μg (2.5 μg per actuation) Tiotropium: 5 μg (2.5 μg per actuation) 2 inhalations a.m. dosing via RESPIMAT® inhaler
57690|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57691|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
58111|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
57707|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57708|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57709|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57710|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57711|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57712|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57713|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57714|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57715|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57716|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57717|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57718|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57719|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57720|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57721|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57722|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57723|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57724|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57725|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler."
57726|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler."
57727|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations ante meridiem (a.m.) dosing."
57728|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations (a.m. dosing) via RESPIMAT® inhaler"
57777|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
57731|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57732|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57733|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57734|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57735|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57736|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57737|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57738|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.
2 inhalations a.m. dosing via RESPIMAT® inhaler"
57739|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57740|NCT02030535|E3|Reported Event|Tiotropium and Olodaterol FC|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination FC (Tio/Olo free combination)
Olodaterol: 5 μg (2.5 μg per actuation)
Tiotropium: 5 μg (2.5 μg per actuation)
2 inhalations a.m. dosing."
57741|NCT02030535|E2|Reported Event|Tio+Olo FDC|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57742|NCT02030535|E1|Reported Event|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.
2 inhalations a.m. dosing."
57743|NCT02030405|B1|Baseline|Ixazomib (MLN9708)|Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
57744|NCT02030405|P1|Participant Flow|Ixazomib (MLN9708)|Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
57745|NCT02030405|O1|Outcome|Ixazomib (MLN9708)|Ixazomib was administered PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
57746|NCT02030405|O1|Outcome|Ixazomib (MLN9708)|Patients receive ixazomib orally on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
57747|NCT02030405|E1|Reported Event|Ixazomib (MLN9708)|Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
57748|NCT02030041|B4|Baseline|Total|Total of all reporting groups
57749|NCT02030041|B3|Baseline|Vitamin D and Placebo|Participants took vitamin D 60000 units once weekly and performed exercise for 12 weeks
57750|NCT02030041|B2|Baseline|Simvastatin and Vitamin D|Participants took simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks
57751|NCT02030041|B1|Baseline|Simvastatin and Placebo|Participants took simvastatin 40 mg once daily and performed exercise for 12 weeks
57752|NCT02030041|P3|Participant Flow|Vitamin D and Placebo|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will exercise for twelve weeks
57753|NCT02030041|P2|Participant Flow|Simvastatin and Vitamin D|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive Simvastatin 40 mg once daily and vitamin D 60000 units once weekly, and will exercise for twelve weeks
57754|NCT02030041|P1|Participant Flow|Simvastatin and Placebo|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive simvastatin 40 mg once daily and placebo once weekly , and will exercise for twelve weeks
57755|NCT02030041|O3|Outcome|Vitamin D and Placebo|Participants received vitamin D 60,000 units once weekly and performed exercise for 12 weeks
57756|NCT02030041|O2|Outcome|Simvastatin and Vitamin D|Participants received simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks
57757|NCT02030041|O1|Outcome|Simvastatin and Placebo|Participants received simvastatin 40 mg once daily and performed exercise for 12 weeks
57758|NCT02030041|O3|Outcome|Vitamin D and Placebo|Participants received vitamin D 60,000 units once weekly and performed exercise for 12 weeks
57759|NCT02030041|O2|Outcome|Simvastatin and Vitamin D|Participants received simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks
57760|NCT02030041|O1|Outcome|Simvastatin and Placebo|Participants received simvastatin 40 mg once daily and performed exercise for 12 weeks
57761|NCT02030041|E3|Reported Event|Vitamin D and Placebo|"Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will exercise for twelve weeks
Vitamin D: Vitamin D will be given to achieve normal serum levels
Placebo: Placebo will be provided to the study participants"
57762|NCT02030041|E2|Reported Event|Simvastatin and Vitamin D|"Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive simvastatin 40 mg once daily and vitamin D 60,000 units once weekly , and will exercise for twelve weeks
Vitamin D: Vitamin D will be given to achieve normal serum levels
Simvastatin: Simvastatin in a dose of 40 mg will be provided to the study participants"
57763|NCT02030041|E1|Reported Event|Simvastatin and Placebo|"Eleven participants will be vitaminD deficient with LDL-C between 100 to 130mg/dl This arm will receive Simvastatin 40 mg once daily and placebo once weekly, and will exercise for twelve weeks
Simvastatin: Simvastatin in a dose of 40 mg will be provided to the study participants
Placebo: Placebo will be provided to the study participants"
57764|NCT02029989|B3|Baseline|Total|Total of all reporting groups
57765|NCT02029989|B2|Baseline|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference"
57786|NCT02029846|O2|Outcome|Incretin-based Treatment|"A regimen including incretin-based drugs
Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
57903|NCT02029495|B3|Baseline|Placebo|"Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24."
57766|NCT02029989|B1|Baseline|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
57767|NCT02029989|P2|Participant Flow|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference"
57768|NCT02029989|P1|Participant Flow|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
57769|NCT02029989|O2|Outcome|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference"
57770|NCT02029989|O1|Outcome|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
57771|NCT02029989|E2|Reported Event|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference"
57772|NCT02029989|E1|Reported Event|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
A1c Now®: Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
QM2000 Circumference measuring tape: Measurement for Central Obesity
Waist and Hip circumference
Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
57773|NCT02029911|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
57774|NCT02029911|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
57775|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
57780|NCT02029846|B2|Baseline|Incretin-based Treatment|"A regimen including incretin-based drugs
Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
57781|NCT02029846|B1|Baseline|Standard Treatment|"A regimen with traditional drugs only
Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
57782|NCT02029846|P2|Participant Flow|Incretin-based Treatment|"A regimen including incretin-based drugs
Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
57783|NCT02029846|P1|Participant Flow|Standard Treatment|"A regimen with traditional drugs only
Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
57784|NCT02029846|O2|Outcome|Incretin-based Treatment|"A regimen including incretin-based drugs
Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
57785|NCT02029846|O1|Outcome|Standard Treatment|"A regimen with traditional drugs only
Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
89793|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
57790|NCT02029846|E2|Reported Event|Incretin-based Treatment|"A regimen including incretin-based drugs
Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
57791|NCT02029846|E1|Reported Event|Standard Treatment|"A regimen with traditional drugs only
Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
57792|NCT02029755|B4|Baseline|Total|Total of all reporting groups
57793|NCT02029755|B3|Baseline|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57794|NCT02029755|B2|Baseline|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57795|NCT02029755|B1|Baseline|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57796|NCT02029755|P3|Participant Flow|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57797|NCT02029755|P2|Participant Flow|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57798|NCT02029755|P1|Participant Flow|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57799|NCT02029755|O3|Outcome|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57800|NCT02029755|O2|Outcome|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57801|NCT02029755|O1|Outcome|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
98083|NCT01791725|E2|Reported Event|ELND005 QD|"ELND005 250 mg QD
ELND005"
57802|NCT02029755|O3|Outcome|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57803|NCT02029755|O2|Outcome|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57804|NCT02029755|O1|Outcome|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57904|NCT02029495|B2|Baseline|140 mg Brodalumab|"Administered via subcutaneous injection
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
57805|NCT02029755|E3|Reported Event|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57806|NCT02029755|E2|Reported Event|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57807|NCT02029755|E1|Reported Event|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
57808|NCT02029703|B3|Baseline|Total|Total of all reporting groups
57809|NCT02029703|B2|Baseline|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.
Synvisc-One Injection"
57810|NCT02029703|B1|Baseline|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.
Sham Injection"
57811|NCT02029703|P2|Participant Flow|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.
Synvisc-One Injection"
57812|NCT02029703|P1|Participant Flow|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.
Sham Injection"
57813|NCT02029703|O2|Outcome|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.
Synvisc-One Injection"
57814|NCT02029703|O1|Outcome|Sham Injection|Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.
57844|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57815|NCT02029703|E2|Reported Event|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.
Synvisc-One Injection"
57816|NCT02029703|E1|Reported Event|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.
Sham Injection"
57817|NCT02029521|B3|Baseline|Total|Total of all reporting groups
57818|NCT02029521|B2|Baseline|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57905|NCT02029495|B1|Baseline|210 mg Brodalumab|"Administered via subcutaneous injections
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
57819|NCT02029521|B1|Baseline|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57820|NCT02029521|P2|Participant Flow|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57821|NCT02029521|P1|Participant Flow|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57822|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57823|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57824|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57825|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57826|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57827|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57828|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57829|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57830|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57831|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57832|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57833|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57834|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57835|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57836|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57837|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57838|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57839|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57840|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57841|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57842|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57843|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57845|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57846|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57847|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57848|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57849|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57850|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57929|NCT02029196|O1|Outcome|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
57851|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57852|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57853|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57854|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57855|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57856|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57857|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57858|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57859|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57860|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57861|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57862|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57863|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57864|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57865|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57866|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57867|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57868|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57869|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57870|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57871|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57872|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57873|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57874|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
101267|NCT01777581|P2|Participant Flow|Sugar Pill (Placebo)|Placebo
57875|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57876|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57877|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57878|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57906|NCT02029495|P3|Participant Flow|Placebo|"Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24."
57879|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57880|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57881|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57882|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57883|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57884|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57885|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57886|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57887|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57888|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57889|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57890|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57891|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57892|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57893|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57894|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57895|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57896|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57897|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57898|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
58022|NCT02028767|B1|Baseline|Fixed Dose Combination vs. Separate Tablets|12.5 mg Empagliflozin / 500mg metformin fixed dose combination vs. free combination of 2.5 mg tablet Empagliflozin, 10 mg tablet Empagliflozin and 500 mg tablet Metformin
58449|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
57899|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57900|NCT02029521|E2|Reported Event|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
57901|NCT02029521|E1|Reported Event|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
57902|NCT02029495|B4|Baseline|Total|Total of all reporting groups
89794|NCT01843374|O2|Outcome|PLACEBO|Placebo.
57907|NCT02029495|P2|Participant Flow|140 mg Brodalumab|"Administered via subcutaneous injection
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
57908|NCT02029495|P1|Participant Flow|210 mg Brodalumab|"Administered via subcutaneous injections
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
57909|NCT02029495|O3|Outcome|Placebo|"Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24."
57910|NCT02029495|O2|Outcome|140 mg Brodalumab|"Administered via subcutaneous injection
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
57911|NCT02029495|O1|Outcome|210 mg Brodalumab|"Administered via subcutaneous injections
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
57912|NCT02029495|O3|Outcome|Placebo|"Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24."
57913|NCT02029495|O2|Outcome|140 mg Brodalumab|"Administered via subcutaneous injection
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
57914|NCT02029495|O1|Outcome|210 mg Brodalumab|"Administered via subcutaneous injections
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
57915|NCT02029495|E3|Reported Event|Placebo|"Administered via subcutaneous injection until week 24.
Placebo: Placebo administered via subcutaneous injection until week 24."
57916|NCT02029495|E2|Reported Event|140 mg Brodalumab|"Administered via subcutaneous injection
140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
57917|NCT02029495|E1|Reported Event|210 mg Brodalumab|"Administered via subcutaneous injections
210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
57918|NCT02029417|B1|Baseline|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
cytarabine: Given SC
omacetaxine mepesuccinate: Given SC
decitabine: Given IV
laboratory biomarker analysis: Correlative studies"
57919|NCT02029417|P1|Participant Flow|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
cytarabine: Given SC
omacetaxine mepesuccinate: Given SC
decitabine: Given IV
laboratory biomarker analysis: Correlative studies"
57920|NCT02029417|O1|Outcome|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
cytarabine: Given SC
omacetaxine mepesuccinate: Given SC
decitabine: Given IV
laboratory biomarker analysis: Correlative studies"
57921|NCT02029417|O1|Outcome|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
cytarabine: Given SC
omacetaxine mepesuccinate: Given SC
decitabine: Given IV
laboratory biomarker analysis: Correlative studies"
58052|NCT02028754|E2|Reported Event|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
102348|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
57922|NCT02029417|E1|Reported Event|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
cytarabine: Given SC
omacetaxine mepesuccinate: Given SC
decitabine: Given IV
laboratory biomarker analysis: Correlative studies"
57923|NCT02029196|B3|Baseline|Total|Total of all reporting groups
57924|NCT02029196|B2|Baseline|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
57925|NCT02029196|B1|Baseline|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
57926|NCT02029196|P2|Participant Flow|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
57927|NCT02029196|P1|Participant Flow|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
57928|NCT02029196|O2|Outcome|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
57930|NCT02029196|O2|Outcome|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
57931|NCT02029196|O1|Outcome|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
57932|NCT02029196|E2|Reported Event|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
57933|NCT02029196|E1|Reported Event|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
57934|NCT02028780|B13|Baseline|Total|Total of all reporting groups
57935|NCT02028780|B12|Baseline|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57936|NCT02028780|B11|Baseline|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57937|NCT02028780|B10|Baseline|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57938|NCT02028780|B9|Baseline|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57939|NCT02028780|B8|Baseline|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57940|NCT02028780|B7|Baseline|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
57941|NCT02028780|B6|Baseline|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
57942|NCT02028780|B5|Baseline|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
57943|NCT02028780|B4|Baseline|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
57944|NCT02028780|B3|Baseline|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
57945|NCT02028780|B2|Baseline|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
57946|NCT02028780|B1|Baseline|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
57947|NCT02028780|P12|Participant Flow|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57948|NCT02028780|P11|Participant Flow|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57949|NCT02028780|P10|Participant Flow|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58100|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58101|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
57950|NCT02028780|P9|Participant Flow|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57951|NCT02028780|P8|Participant Flow|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57952|NCT02028780|P7|Participant Flow|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
57953|NCT02028780|P6|Participant Flow|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
57954|NCT02028780|P5|Participant Flow|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
57955|NCT02028780|P4|Participant Flow|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
57956|NCT02028780|P3|Participant Flow|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
57957|NCT02028780|P2|Participant Flow|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
57958|NCT02028780|P1|Participant Flow|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
57959|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57960|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57961|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57962|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57963|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
57964|NCT02028780|O1|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
57965|NCT02028780|O7|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57966|NCT02028780|O6|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57967|NCT02028780|O5|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57968|NCT02028780|O4|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57969|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
57970|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
57971|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
57972|NCT02028780|O8|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57973|NCT02028780|O7|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58102|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
57974|NCT02028780|O6|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57975|NCT02028780|O5|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57976|NCT02028780|O4|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
57977|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
57978|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
57979|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
57980|NCT02028780|O8|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58122|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
57981|NCT02028780|O7|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57982|NCT02028780|O6|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57983|NCT02028780|O5|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57984|NCT02028780|O4|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
57985|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
57986|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
57987|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
57988|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57989|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57990|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57991|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57992|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
57993|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57994|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57995|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57996|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58023|NCT02028767|P2|Participant Flow|Separate Tablets First, Then Fixed Dose Combination (FDC)|"free combination of Empagliflozin 2.5 mg tablet, Empagliflozin 10 mg tablet and Metformin 500 mg tablet first,
then Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin
Both medications were administered oral with 240 mL water after intake of a high-fat, high-calorie meal."
57997|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
57998|NCT02028780|O12|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
57999|NCT02028780|O11|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58000|NCT02028780|O10|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58030|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination
Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
58001|NCT02028780|O9|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58002|NCT02028780|O8|Outcome|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58003|NCT02028780|O7|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
58004|NCT02028780|O6|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
58005|NCT02028780|O5|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
58006|NCT02028780|O4|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
58007|NCT02028780|O3|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
58008|NCT02028780|O2|Outcome|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
58009|NCT02028780|O1|Outcome|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
58010|NCT02028780|E12|Reported Event|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58011|NCT02028780|E11|Reported Event|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58012|NCT02028780|E10|Reported Event|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58013|NCT02028780|E9|Reported Event|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58014|NCT02028780|E8|Reported Event|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
58015|NCT02028780|E7|Reported Event|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
58016|NCT02028780|E6|Reported Event|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
58017|NCT02028780|E5|Reported Event|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
58018|NCT02028780|E4|Reported Event|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
58019|NCT02028780|E3|Reported Event|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
58020|NCT02028780|E2|Reported Event|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
58021|NCT02028780|E1|Reported Event|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
58103|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58024|NCT02028767|P1|Participant Flow|Fixed Dose Combination (FDC) First, Then Separate Tablets|"Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin first,
then free combination of Empagliflozin 2.5 mg tablet, Empagliflozin 10 mg tablet and Metformin 500 mg tablet
Both medications were administered oral with 240 mL water after intake of a high-fat, high-calorie meal."
58025|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets
Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet
Empagliflozin 10 mg: Empagliflozin 10 mg tablet
Metformin 500 mg: Metformin 500 mg tablet"
58026|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination
Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
58027|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets
Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet
Empagliflozin 10 mg: Empagliflozin 10 mg tablet
Metformin 500 mg: Metformin 500 mg tablet"
58028|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination
Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
58029|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets
Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet
Empagliflozin 10 mg: Empagliflozin 10 mg tablet
Metformin 500 mg: Metformin 500 mg tablet"
63658|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select VFI variables
58031|NCT02028767|E2|Reported Event|Separate Tablets|"Empagliflozin and Metformin tablets
Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet
Empagliflozin 10 mg: Empagliflozin 10 mg tablet
Metformin 500 mg: Metformin 500 mg tablet"
58032|NCT02028767|E1|Reported Event|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination
Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
58033|NCT02028754|B3|Baseline|Total|Total of all reporting groups
58034|NCT02028754|B2|Baseline|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58035|NCT02028754|B1|Baseline|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58036|NCT02028754|P2|Participant Flow|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58037|NCT02028754|P1|Participant Flow|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58038|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58039|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58040|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58041|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58042|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58043|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58044|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58045|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58046|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58047|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58048|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58049|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58050|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58051|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58053|NCT02028754|E1|Reported Event|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
58054|NCT02028676|B10|Baseline|Total|Total of all reporting groups
58055|NCT02028676|B9|Baseline|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.
Stopped cotrimoxazole prophylaxis"
58056|NCT02028676|B8|Baseline|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole
Continued cotrimoxazole prophylaxis"
58057|NCT02028676|B7|Baseline|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO
Twice-daily ABC+3TC"
58058|NCT02028676|B6|Baseline|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO
Once-daily ABC+3TC"
63659|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select VFI variables
58059|NCT02028676|B5|Baseline|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58060|NCT02028676|B4|Baseline|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58061|NCT02028676|B3|Baseline|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.
Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58062|NCT02028676|B2|Baseline|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58063|NCT02028676|B1|Baseline|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58064|NCT02028676|P9|Participant Flow|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.
Stopped cotrimoxazole prophylaxis"
58065|NCT02028676|P8|Participant Flow|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole
Continued cotrimoxazole prophylaxis"
58066|NCT02028676|P7|Participant Flow|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO
Twice-daily ABC+3TC"
58067|NCT02028676|P6|Participant Flow|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO
Once-daily ABC+3TC"
58104|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58105|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
102349|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
58068|NCT02028676|P5|Participant Flow|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58118|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58119|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58120|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89795|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
58069|NCT02028676|P4|Participant Flow|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58070|NCT02028676|P3|Participant Flow|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.
Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58071|NCT02028676|P2|Participant Flow|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58072|NCT02028676|P1|Participant Flow|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58073|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58074|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58075|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58076|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58077|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58078|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58079|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58080|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58081|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58082|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58083|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58084|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58085|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58086|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58087|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58088|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58089|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58090|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58091|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58092|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58093|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58094|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58095|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58096|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58097|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58098|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58099|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58450|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58112|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58113|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58114|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58115|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58116|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58117|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
89796|NCT01843374|O2|Outcome|PLACEBO|Placebo.
58123|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58124|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58125|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58126|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58127|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58128|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58129|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58130|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58131|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58132|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58133|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58134|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58135|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58136|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58137|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58138|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58139|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58140|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58141|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58142|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58143|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58144|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58145|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58146|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58147|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58148|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58149|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58150|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58151|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58273|NCT02028065|B2|Baseline|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58152|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58153|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58163|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58154|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58155|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58156|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58157|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58158|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58159|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58160|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58161|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58183|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58451|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58162|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58282|NCT02028065|O2|Outcome|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58496|NCT02024932|B4|Baseline|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58164|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58165|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58166|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58167|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58168|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58169|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58170|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58171|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58172|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58274|NCT02028065|B1|Baseline|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58173|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58174|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58283|NCT02028065|O1|Outcome|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
89797|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
58175|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58176|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58177|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58178|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58179|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58180|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58181|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58182|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58275|NCT02028065|P3|Participant Flow|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
102350|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
58184|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58284|NCT02028065|E3|Reported Event|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58603|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.
Omafilcon A: contact lens"
58185|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58186|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58187|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58188|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58189|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58190|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58191|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58192|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58193|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58194|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58276|NCT02028065|P2|Participant Flow|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58223|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58195|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58196|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58197|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58198|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58199|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58200|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58201|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58202|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58203|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58204|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58222|NCT02028676|O3|Outcome|ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
58452|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
102351|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
58205|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58206|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
58207|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58208|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58209|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58210|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58211|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58212|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58213|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58214|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58215|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58216|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
58217|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:
trimethoprim+sulfamethoxazole"
58218|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58219|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58220|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58221|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
58277|NCT02028065|P1|Participant Flow|Placebo|Administration of 3 single intravenous (IV) doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58278|NCT02028065|O3|Outcome|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58224|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58225|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
58226|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58227|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58228|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
58229|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:
ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58230|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:
ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58231|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58232|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58233|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58245|NCT02028325|P1|Participant Flow|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
102352|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
58279|NCT02028065|O2|Outcome|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58280|NCT02028065|O1|Outcome|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58281|NCT02028065|O3|Outcome|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58234|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58235|NCT02028676|E9|Reported Event|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.
Stopped cotrimoxazole prophylaxis"
58236|NCT02028676|E8|Reported Event|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole
Continued cotrimoxazole prophylaxis"
58237|NCT02028676|E7|Reported Event|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO
Twice-daily ABC+3TC"
58238|NCT02028676|E6|Reported Event|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO
Once-daily ABC+3TC"
58239|NCT02028676|E5|Reported Event|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58240|NCT02028676|E4|Reported Event|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58241|NCT02028676|E3|Reported Event|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.
Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
58242|NCT02028676|E2|Reported Event|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58243|NCT02028676|E1|Reported Event|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
58244|NCT02028325|B1|Baseline|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
58453|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58246|NCT02028325|O1|Outcome|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
58247|NCT02028325|E1|Reported Event|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
58248|NCT02028169|B1|Baseline|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58249|NCT02028169|P1|Participant Flow|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed psoriatic arthritis (PsA) for which the physician has initiated treatment with an anti-tumor necrosis factor (TNF).
58250|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58251|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58252|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58253|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58254|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58255|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58256|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58257|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58258|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58259|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58260|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58261|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58262|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58263|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58264|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58265|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58266|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58267|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58268|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58269|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58270|NCT02028169|E1|Reported Event|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
58271|NCT02028065|B4|Baseline|Total|Total of all reporting groups
58272|NCT02028065|B3|Baseline|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58285|NCT02028065|E2|Reported Event|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58286|NCT02028065|E1|Reported Event|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
58287|NCT02027883|B3|Baseline|Total|Total of all reporting groups
58288|NCT02027883|B2|Baseline|Experimental Parameter|"Educated T shock setting
Educated T shock setting: Experimental Parameter Set 2 Programming Values"
58289|NCT02027883|B1|Baseline|Nominal Parameter|"Nominal T shock setting
Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
58290|NCT02027883|P2|Participant Flow|Experimental Parameter|"Educated T shock setting
Educated T shock setting: Experimental Parameter Set 2 Programming Values"
58291|NCT02027883|P1|Participant Flow|Nominal Parameter|"Nominal T shock setting
Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
58292|NCT02027883|O2|Outcome|Experimental Parameter|"Educated T shock setting
Educated T shock setting: Experimental Parameter Set 2 Programming Values
The educated T shock setting method was successful in 70% of the patients. 35 out of 50 patients Ventricular Fibrillation was induced with the educated T- shock method. Of the 12 patients that were did not have Ventricular fibrillation induced with the nominal T-shock method, they were all successfully induced with the educated T-Shock method."
58293|NCT02027883|O1|Outcome|Nominal Parameter|"Nominal T shock setting
Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust
The standard T-Shock method was successful in 76% of the patients. 38 out of 50 patients Ventricular Fibrillation was induced with the nominal T shock method. In contrast, 87 % or 13 out of 15 that failed to induce Ventricular Fibrillation using the educated T-Shock method was successfully induced when crossed to the nominal T-shock method."
58294|NCT02027883|O2|Outcome|Experimental Parameter|Educated T shock setting: Experimental Parameter Set 2 Programming Values.
58295|NCT02027883|O1|Outcome|Nominal Parameter|Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust.
58296|NCT02027883|O2|Outcome|Experimental Parameter|"Educated T shock setting
Educated T shock setting: Experimental Parameter Set 2 Programming Values"
58297|NCT02027883|O1|Outcome|Nominal Parameter|"Nominal T shock setting
Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
58298|NCT02027883|E2|Reported Event|Experimental Parameter|"Educated T shock setting
Educated T shock setting: Experimental Parameter Set 2 Programming Values"
58299|NCT02027883|E1|Reported Event|Nominal Parameter|"Nominal T shock setting
Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
58300|NCT02027844|B4|Baseline|Total|Total of all reporting groups
58301|NCT02027844|B3|Baseline|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
parental presence: parental presence during inhalational induction of sevoflurane"
58302|NCT02027844|B2|Baseline|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane"
58303|NCT02027844|B1|Baseline|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
58304|NCT02027844|P3|Participant Flow|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
parental presence: parental presence during inhalational induction of sevoflurane"
58305|NCT02027844|P2|Participant Flow|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane"
58306|NCT02027844|P1|Participant Flow|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
58307|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
parental presence: parental presence during inhalational induction of sevoflurane"
58308|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane"
58309|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
58310|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
parental presence: parental presence during inhalational induction of sevoflurane"
58311|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane"
58312|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
58313|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
parental presence: parental presence during inhalational induction of sevoflurane"
58314|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane"
58315|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
58494|NCT02024932|B6|Baseline|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
58316|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
parental presence: parental presence during inhalational induction of sevoflurane"
58317|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane"
58318|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
58319|NCT02027844|E3|Reported Event|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
parental presence: parental presence during inhalational induction of sevoflurane"
58320|NCT02027844|E2|Reported Event|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane"
58321|NCT02027844|E1|Reported Event|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
58322|NCT02027402|B3|Baseline|Total|Total of all reporting groups
58323|NCT02027402|B2|Baseline|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
58324|NCT02027402|B1|Baseline|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.
Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
58325|NCT02027402|P2|Participant Flow|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
58326|NCT02027402|P1|Participant Flow|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.
Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
58327|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
58328|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.
Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
58329|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
58330|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.
Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
58331|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
58332|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.
Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
58333|NCT02027402|O2|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.
Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
58334|NCT02027402|O1|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
58335|NCT02027402|E2|Reported Event|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
58336|NCT02027402|E1|Reported Event|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.
Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
58337|NCT02027311|B3|Baseline|Total|Total of all reporting groups
58338|NCT02027311|B2|Baseline|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
58339|NCT02027311|B1|Baseline|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
58340|NCT02027311|P2|Participant Flow|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
58399|NCT02026141|E2|Reported Event|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,
Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.
midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.
Normal Saline Placebo"
58341|NCT02027311|P1|Participant Flow|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
58342|NCT02027311|O2|Outcome|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
58343|NCT02027311|O1|Outcome|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
58344|NCT02027311|O2|Outcome|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
58345|NCT02027311|O1|Outcome|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
58346|NCT02027311|E2|Reported Event|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
58347|NCT02027311|E1|Reported Event|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
58348|NCT02027272|B3|Baseline|Total|Total of all reporting groups
58349|NCT02027272|B2|Baseline|Placebo|Placebo, 2 doses, 12 hours apart
58350|NCT02027272|B1|Baseline|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.
Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
58351|NCT02027272|P2|Participant Flow|Placebo|Placebo, 2 doses, 12 hours apart
58352|NCT02027272|P1|Participant Flow|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.
Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
58353|NCT02027272|O2|Outcome|Placebo|Placebo, 2 doses, 12 hours apart
58354|NCT02027272|O1|Outcome|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.
Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
58355|NCT02027272|E2|Reported Event|Placebo|Placebo, 2 doses, 12 hours apart
58356|NCT02027272|E1|Reported Event|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.
Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
58357|NCT02026258|B3|Baseline|Total|Total of all reporting groups
58358|NCT02026258|B2|Baseline|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
102353|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
58398|NCT02026141|O1|Outcome|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.
Once the patient's spinal is performed, patient will receive the following:
Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.
Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.
Dexmedetomidine"
58495|NCT02024932|B5|Baseline|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58359|NCT02026258|B1|Baseline|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
58360|NCT02026258|P2|Participant Flow|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. Time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The de"
58361|NCT02026258|P1|Participant Flow|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
58362|NCT02026258|O2|Outcome|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
58363|NCT02026258|O1|Outcome|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
58364|NCT02026258|O2|Outcome|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
58365|NCT02026258|O1|Outcome|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
58366|NCT02026258|O2|Outcome|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
58397|NCT02026141|O2|Outcome|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,
Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.
midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.
Normal Saline Placebo"
58367|NCT02026258|O1|Outcome|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
58368|NCT02026258|O2|Outcome|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
58369|NCT02026258|O1|Outcome|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
58370|NCT02026258|E2|Reported Event|Orthodontics With Piezotome Corticision|"Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone."
58371|NCT02026258|E1|Reported Event|Orthodontics no Piezocision|"Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment."
58372|NCT02026206|B3|Baseline|Total|Total of all reporting groups
58373|NCT02026206|B2|Baseline|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.
Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
58374|NCT02026206|B1|Baseline|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.
low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
58375|NCT02026206|P2|Participant Flow|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.
Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
58376|NCT02026206|P1|Participant Flow|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.
low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
58441|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58442|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58377|NCT02026206|O2|Outcome|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.
Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
58378|NCT02026206|O1|Outcome|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.
low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
58379|NCT02026206|O2|Outcome|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.
Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
58380|NCT02026206|O1|Outcome|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.
low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
58381|NCT02026206|E2|Reported Event|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.
Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
58382|NCT02026206|E1|Reported Event|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.
low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
58383|NCT02026193|B3|Baseline|Total|Total of all reporting groups
58384|NCT02026193|B2|Baseline|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.
embryo freezing"
58385|NCT02026193|B1|Baseline|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.
oocyte vitrification"
58386|NCT02026193|P2|Participant Flow|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.
embryo freezing"
58387|NCT02026193|P1|Participant Flow|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.
oocyte vitrification"
58388|NCT02026193|O2|Outcome|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.
embryo freezing"
58389|NCT02026193|O1|Outcome|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.
oocyte vitrification"
58390|NCT02026193|E2|Reported Event|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.
embryo freezing"
58391|NCT02026193|E1|Reported Event|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.
oocyte vitrification"
58392|NCT02026141|B3|Baseline|Total|Total of all reporting groups
58393|NCT02026141|B2|Baseline|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,
Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.
midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.
Normal Saline Placebo"
58394|NCT02026141|B1|Baseline|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.
Once the patient's spinal is performed, patient will receive the following:
Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr
Infusion will be stopped after the last staple or suture is performed on the incision.
Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation as defined by ASA.
Dexmedetomidine"
58395|NCT02026141|P2|Participant Flow|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,
Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.
midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.
Normal Saline Placebo"
58396|NCT02026141|P1|Participant Flow|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.
Once the patient's spinal is performed, patient will receive the following:
Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.
Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.
Dexmedetomidine"
58443|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58444|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58400|NCT02026141|E1|Reported Event|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.
Once the patient's spinal is performed, patient will receive the following:
Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.
Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.
Dexmedetomidine"
58401|NCT02025907|B3|Baseline|Total|Total of all reporting groups
58402|NCT02025907|B2|Baseline|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
58403|NCT02025907|B1|Baseline|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
58404|NCT02025907|P2|Participant Flow|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
58405|NCT02025907|P1|Participant Flow|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
58406|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
58407|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
58408|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
58409|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
58410|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
58411|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
58412|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
58413|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
58414|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
58415|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
58416|NCT02025907|E2|Reported Event|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
58417|NCT02025907|E1|Reported Event|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
58418|NCT02025829|B3|Baseline|Total|Total of all reporting groups
58419|NCT02025829|B2|Baseline|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
58420|NCT02025829|B1|Baseline|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
58421|NCT02025829|P2|Participant Flow|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
58422|NCT02025829|P1|Participant Flow|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
58423|NCT02025829|O2|Outcome|End of Exacerbation|Study volunteer at the completion of 2 weeks IV antibiotic treatment for a pulmonary exacerbation
58424|NCT02025829|O1|Outcome|Begining of Exacerbation|Study volunteer at the beginning of IV antibiotic treatment for a pulmonary exacerbation
58425|NCT02025829|O1|Outcome|Clinically Stable Cohort|Clinically stable subjects
58426|NCT02025829|O2|Outcome|End of Exacerbation|Study volunteer at the completion of 2 weeks IV antibiotic treatment for a pulmonary exacerbation
58427|NCT02025829|O1|Outcome|Begining of Exacerbation|Study volunteer at the beginning of IV antibiotic treatment for a pulmonary exacerbation
58428|NCT02025829|E2|Reported Event|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
58429|NCT02025829|E1|Reported Event|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
58430|NCT02025647|B1|Baseline|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58431|NCT02025647|P1|Participant Flow|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58432|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58433|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58434|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58435|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58436|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58437|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58438|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58439|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58440|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58454|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58455|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58456|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58457|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58458|NCT02025647|E1|Reported Event|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
58459|NCT02025075|B3|Baseline|Total|Total of all reporting groups
58492|NCT02024971|E1|Reported Event|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
58460|NCT02025075|B2|Baseline|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).
Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
58461|NCT02025075|B1|Baseline|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).
Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
58462|NCT02025075|P2|Participant Flow|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).
Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
58463|NCT02025075|P1|Participant Flow|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).
Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
58464|NCT02025075|O2|Outcome|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).
Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
58465|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).
Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
58466|NCT02025075|O6|Outcome|Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
58467|NCT02025075|O5|Outcome|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
58468|NCT02025075|O4|Outcome|Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
58469|NCT02025075|O3|Outcome|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
58470|NCT02025075|O2|Outcome|Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
58471|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
58472|NCT02025075|O6|Outcome|Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
58473|NCT02025075|O5|Outcome|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
58474|NCT02025075|O4|Outcome|Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
58475|NCT02025075|O3|Outcome|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
58476|NCT02025075|O2|Outcome|Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
58477|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
58478|NCT02025075|O6|Outcome|Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
58479|NCT02025075|O5|Outcome|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
58480|NCT02025075|O4|Outcome|Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
58481|NCT02025075|O3|Outcome|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
58482|NCT02025075|O2|Outcome|Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
58483|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
58484|NCT02025075|E2|Reported Event|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).
Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
58485|NCT02025075|E1|Reported Event|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).
Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
58486|NCT02024971|B1|Baseline|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
58487|NCT02024971|P1|Participant Flow|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
58488|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
58489|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
58490|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
58491|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
58493|NCT02024932|B7|Baseline|Total|Total of all reporting groups
58497|NCT02024932|B3|Baseline|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
58498|NCT02024932|B2|Baseline|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58499|NCT02024932|B1|Baseline|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58500|NCT02024932|P6|Participant Flow|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
58501|NCT02024932|P5|Participant Flow|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58502|NCT02024932|P4|Participant Flow|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58503|NCT02024932|P3|Participant Flow|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
58504|NCT02024932|P2|Participant Flow|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58505|NCT02024932|P1|Participant Flow|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58506|NCT02024932|O4|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58507|NCT02024932|O3|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58508|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58509|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58510|NCT02024932|O4|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58511|NCT02024932|O3|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58512|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58513|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58514|NCT02024932|O4|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58515|NCT02024932|O3|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58516|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58517|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58518|NCT02024932|O4|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58519|NCT02024932|O3|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58520|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58521|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
60126|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
58522|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58523|NCT02024932|O1|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58524|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58525|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58526|NCT02024932|O1|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58527|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58528|NCT02024932|O1|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58604|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.
Etafilcon A: contact lens"
63660|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select VFI variables
58529|NCT02024932|O1|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58530|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58531|NCT02024932|O1|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58532|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58533|NCT02024932|O1|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58534|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58535|NCT02024932|O1|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58536|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58537|NCT02024932|O2|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
58538|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58539|NCT02024932|O2|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
58540|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58541|NCT02024932|O2|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
58542|NCT02024932|O1|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58543|NCT02024932|O6|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
58544|NCT02024932|O5|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58545|NCT02024932|O4|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58546|NCT02024932|O3|Outcome|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
58547|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58548|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58549|NCT02024932|O6|Outcome|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
58550|NCT02024932|O5|Outcome|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58551|NCT02024932|O4|Outcome|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58552|NCT02024932|O3|Outcome|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
58553|NCT02024932|O2|Outcome|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58554|NCT02024932|O1|Outcome|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58555|NCT02024932|E6|Reported Event|Placebo Part B Double Blind (Cohort 5)|Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
58556|NCT02024932|E5|Reported Event|BVS857 Part B Double Blind (Cohort 5)|Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks.
58557|NCT02024932|E4|Reported Event|BVS857 Part B Open-label (Cohort 4)|Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks.
58558|NCT02024932|E3|Reported Event|BVS857 Part A Double Blind (Cohort 2)|Participants received single doses of 0.03 mg/kg BVS857 i.v. on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.)
58559|NCT02024932|E2|Reported Event|Placebo Part A Double Blind (Cohort 2)|Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57.
58605|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.
Omafilcon A: contact lens"
63661|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select VFI variables
58560|NCT02024932|E1|Reported Event|BVS857 Part A Open Label (Cohort 1)|Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57.
58561|NCT02024867|B3|Baseline|Total|Total of all reporting groups
58562|NCT02024867|B2|Baseline|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58563|NCT02024867|B1|Baseline|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58564|NCT02024867|P2|Participant Flow|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58565|NCT02024867|P1|Participant Flow|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58566|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58567|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58568|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58569|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58570|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58571|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58572|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58573|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58574|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58575|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58576|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58577|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58578|NCT02024867|E2|Reported Event|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58579|NCT02024867|E1|Reported Event|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
58580|NCT02024724|B3|Baseline|Total|Total of all reporting groups
58581|NCT02024724|B2|Baseline|Group 1|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Triamcinolone: 40 mg of Triamcinolone"
58582|NCT02024724|B1|Baseline|Group 2|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Dexamethasone: 4 mg of Dexamethasone"
58583|NCT02024724|P2|Participant Flow|Group 1|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Triamcinolone: 40 mg of Triamcinolone"
58584|NCT02024724|P1|Participant Flow|Group 2|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Dexamethasone: 4 mg of Dexamethasone"
58585|NCT02024724|O2|Outcome|Group 2|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Triamcinolone: 40 mg of Triamcinolone"
58586|NCT02024724|O1|Outcome|Group 1|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Dexamethasone: 4 mg of Dexamethasone"
58587|NCT02024724|E2|Reported Event|Group 2|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Triamcinolone: 40 mg of Triamcinolone"
58588|NCT02024724|E1|Reported Event|Group 1|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Bupivacaine: 4 mL of 0.25% bupivacaine
Dexamethasone: 4 mg of Dexamethasone"
58589|NCT02024698|B1|Baseline|Overall Study Group|Study participants are randomized to wear omafilcon A or etafilcon A pair of study lenses then crossover to the alternate pair.
58590|NCT02024698|P2|Participant Flow|Omafilcon A First, Then Etafilcon A|Study participants are randomized to wear omafilcon A pair of study lenses then crossover to the alternate pair.
58591|NCT02024698|P1|Participant Flow|Etafilcon A First, Then Omafilcon A|Study participants are randomized to wear etafilcon A pair of study lenses then crossover to the alternate pair.
58592|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.
Etafilcon A: contact lens"
58593|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.
Omafilcon A: contact lens"
58594|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.
Etafilcon A: contact lens"
58595|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.
Omafilcon A: contact lens"
58596|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.
Etafilcon A: contact lens"
60127|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
58597|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.
Omafilcon A: contact lens"
58598|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.
Etafilcon A: contact lens"
58599|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.
Omafilcon A: contact lens"
58600|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.
Etafilcon A: contact lens"
58601|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.
Omafilcon A: contact lens"
58602|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.
Etafilcon A: contact lens"
58606|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.
Etafilcon A: contact lens"
58607|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.
Omafilcon A: contact lens"
58608|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.
Etafilcon A: contact lens"
58609|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.
Omafilcon A: contact lens"
58610|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.
Etafilcon A: contact lens"
58611|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.
Omafilcon A: contact lens"
58612|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.
Etafilcon A: contact lens"
58613|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.
Omafilcon A: contact lens"
58614|NCT02024698|E2|Reported Event|Etafilcon A|Study participants are randomized to wear etafilcon A lenses.
58615|NCT02024698|E1|Reported Event|Omafilcon A|Study participants are randomized to wear omafilcon A lenses.
58616|NCT02024386|B4|Baseline|Total|Total of all reporting groups
58617|NCT02024386|B3|Baseline|Control Arm|"No drug
After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
58618|NCT02024386|B2|Baseline|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58619|NCT02024386|B1|Baseline|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58620|NCT02024386|P3|Participant Flow|Control Arm|"No drug
After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
58621|NCT02024386|P2|Participant Flow|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58622|NCT02024386|P1|Participant Flow|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58623|NCT02024386|O3|Outcome|Control Arm|"No drug
After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
58624|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58625|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58626|NCT02024386|O3|Outcome|Control Arm|"No drug
After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
58627|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58628|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58629|NCT02024386|O3|Outcome|Control Arm|"No drug
After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
58630|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58631|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58632|NCT02024386|O3|Outcome|Control Arm|"No drug
After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
58633|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
60128|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
58634|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58635|NCT02024386|O3|Outcome|Control Arm|"No drug
After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
58636|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58637|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
59522|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
58638|NCT02024386|O3|Outcome|Control Arm|"No drug
After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
58639|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58640|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
58641|NCT02024386|E3|Reported Event|Control Arm|"No drug
After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
58642|NCT02024386|E2|Reported Event|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. Riociguat will be administered at the 90-minute mark of this rest period. A second VO2 max test will be repeated at altitude."
58643|NCT02024386|E1|Reported Event|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5
Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. Riociguat will be administered at the 90-minute mark of this rest period. A second VO2 max test will be repeated at altitude."
58644|NCT02024165|B1|Baseline|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and Ultrasound
58645|NCT02024165|P1|Participant Flow|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE and Ultrasound
58646|NCT02024165|O2|Outcome|Electrode Sensor, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or Ultrasound
58647|NCT02024165|O1|Outcome|Electrode Sensor, FSE|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE
58648|NCT02024165|E1|Reported Event|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and ultrasound
58649|NCT02023983|B3|Baseline|Total|Total of all reporting groups
58650|NCT02023983|B2|Baseline|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
58651|NCT02023983|B1|Baseline|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
58652|NCT02023983|P2|Participant Flow|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
58653|NCT02023983|P1|Participant Flow|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
58654|NCT02023983|O2|Outcome|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
58655|NCT02023983|O1|Outcome|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
58656|NCT02023983|O2|Outcome|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
58657|NCT02023983|O1|Outcome|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
58658|NCT02023983|E2|Reported Event|Standard Discharge|Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
58659|NCT02023983|E1|Reported Event|Early Discharge|Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
58660|NCT02023918|B1|Baseline|Pegvisomant Arm|pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
58661|NCT02023918|P1|Participant Flow|Pegvisomant Arm|"Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study."
58662|NCT02023918|O1|Outcome|Pegvisomant Arm|Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
58663|NCT02023918|O1|Outcome|Pegvisomant Arm|Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
60129|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
58664|NCT02023918|E1|Reported Event|Pegvisomant Arm|pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
58665|NCT02023879|B4|Baseline|Total|Total of all reporting groups
58666|NCT02023879|B3|Baseline|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58755|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
58756|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
58667|NCT02023879|B2|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58668|NCT02023879|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58669|NCT02023879|P3|Participant Flow|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection every 4 weeks (Q4W) alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58670|NCT02023879|P2|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58671|NCT02023879|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
58672|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58673|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58674|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58675|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58676|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58677|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58678|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58679|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58680|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58681|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58682|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58683|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58684|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58685|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
102354|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
58686|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58687|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
63662|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select OHN variables
58688|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58689|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58690|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58691|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58692|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58693|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58694|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58695|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58696|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58697|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58698|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58699|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58700|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58701|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58702|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58703|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58704|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58705|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58706|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58707|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58752|NCT02023879|E1|Reported Event|Placebo Q2W|Participants exposed to placebo SC injection Q2W added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
58708|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
59523|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
58709|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58710|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58711|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58712|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58713|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58714|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58715|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58716|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58717|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58718|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58719|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58720|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58721|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58722|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58723|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58724|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58725|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58726|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58727|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58728|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58751|NCT02023879|E2|Reported Event|Alirocumab 75 Q2W/Up150 Q2W|Participants exposed to alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
59520|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
58729|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58730|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58731|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58732|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58733|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58734|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58735|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58736|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58737|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58738|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58739|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58740|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58741|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58742|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58743|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58744|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58745|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58746|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58747|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58748|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
58749|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
58750|NCT02023879|E3|Reported Event|Alirocumab 150 Q4W/Up150 Q2W|Participants exposed to alirocumab 150 mg Q4W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 22 weeks).
60130|NCT02013687|E4|Reported Event|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
58753|NCT02023801|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
58754|NCT02023801|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
58757|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
58758|NCT02023801|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation
Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
58759|NCT02023515|B3|Baseline|Total|Total of all reporting groups
58760|NCT02023515|B2|Baseline|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Behavioral weight loss: Standard behavioral weight loss"
58761|NCT02023515|B1|Baseline|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.
Emotional brain training: Stress management based program"
58762|NCT02023515|P2|Participant Flow|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Behavioral weight loss: Standard behavioral weight loss"
58763|NCT02023515|P1|Participant Flow|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.
Emotional brain training: Stress management based program"
58764|NCT02023515|O2|Outcome|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Behavioral weight loss: Standard behavioral weight loss"
58765|NCT02023515|O1|Outcome|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.
Emotional brain training: Stress management based program"
58766|NCT02023515|O2|Outcome|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Behavioral weight loss: Standard behavioral weight loss"
58767|NCT02023515|O1|Outcome|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.
Emotional brain training: Stress management based program"
58768|NCT02023515|E2|Reported Event|Standard Behavioral Weight Loss|"Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Behavioral weight loss: Standard behavioral weight loss"
58769|NCT02023515|E1|Reported Event|Stress Management|"Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.
Emotional brain training: Stress management based program"
58770|NCT02023268|B3|Baseline|Total|Total of all reporting groups
58771|NCT02023268|B2|Baseline|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
58772|NCT02023268|B1|Baseline|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
58773|NCT02023268|P2|Participant Flow|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
58774|NCT02023268|P1|Participant Flow|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
58775|NCT02023268|O2|Outcome|Vismed|Vismed : 1 drop in each eye 3 to 6 times daily during 84 days
58776|NCT02023268|O1|Outcome|T2762|T2762: drop in each eye 3 to 6 times daily during 84 days
58777|NCT02023268|E2|Reported Event|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
58778|NCT02023268|E1|Reported Event|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
58779|NCT02023125|B3|Baseline|Total|Total of all reporting groups
58780|NCT02023125|B2|Baseline|Group 2: Alectinib Alone, Alectinib + Esomeprazole|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58781|NCT02023125|B1|Baseline|Group 1 (Treatment Sequence AB or BA)|Participants in Group 1 were randomly assigned to a two period treatment sequence (AB or BA) in which they received a single, oral dose of 600 mg of alectinib per period separated by at least 10 days. Each participant received single, oral doses alectinib given under fasted conditions (Treatment A) or following the ingestion of a high fat, high calorie meal (Treatment B) as determined by their assigned sequence.
58799|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58800|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
102355|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
58801|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58845|NCT02023112|P2|Participant Flow|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
58782|NCT02023125|P3|Participant Flow|Group 2: Alectinib Alone, Alectinib + Esomeprazole|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58783|NCT02023125|P2|Participant Flow|Group 1: Treatment B First, Then Treatment A|Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered. Each period was separated by at least 10 days.
58784|NCT02023125|P1|Participant Flow|Group 1: Treatment A First, Then Treatment B|Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600 milligrams (mg) oral dose of alectinib was administered. Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Each period was separated by at least 10 days.
58785|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58786|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58787|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58788|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58789|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58790|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58791|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58792|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58793|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Day 16): Participants started the standardized meal 30 minutes prior to administration of alectinib. Participants were to consume this meal in 30 minutes or less. A single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Period 2 (Days 11 to 20): From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40-mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal.
58794|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58795|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58796|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58797|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58798|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
60131|NCT02013687|E3|Reported Event|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
58802|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58803|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58804|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58805|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58806|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58807|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58808|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58809|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58810|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58811|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58812|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58813|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58814|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58815|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58816|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58817|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58818|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58819|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58820|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58841|NCT02023125|E1|Reported Event|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58821|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58822|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58823|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58824|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58825|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58826|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58827|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58828|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58829|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58830|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58831|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58832|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58833|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58834|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58835|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58836|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
58837|NCT02023125|E5|Reported Event|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
58838|NCT02023125|E4|Reported Event|Group 2: Period 2 (Esomeprazole Alone)|Period 2: From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast.
58839|NCT02023125|E3|Reported Event|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
58840|NCT02023125|E2|Reported Event|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
58842|NCT02023112|B3|Baseline|Total|Total of all reporting groups
58843|NCT02023112|B2|Baseline|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
58844|NCT02023112|B1|Baseline|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
59524|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
58846|NCT02023112|P1|Participant Flow|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks
58847|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
58848|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
58849|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
58850|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
58851|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
58852|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
58853|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
58854|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
58855|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
58856|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
58857|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
58858|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
58859|NCT02023112|E4|Reported Event|ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in cirrhotic participants
58860|NCT02023112|E3|Reported Event|ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in cirrhotic participants
58861|NCT02023112|E2|Reported Event|ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in non-cirrhotic participants
58862|NCT02023112|E1|Reported Event|ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in non-cirrhotic participants
58863|NCT02023099|B4|Baseline|Total|Total of all reporting groups
58864|NCT02023099|B3|Baseline|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
58865|NCT02023099|B2|Baseline|Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA|DB placebo QD for 12 weeks followed by OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
58866|NCT02023099|B1|Baseline|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
58867|NCT02023099|P3|Participant Flow|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
58868|NCT02023099|P2|Participant Flow|Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA|DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
58869|NCT02023099|P1|Participant Flow|Substudy 1, Arm A: DB 2-DAA|Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis
58870|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
58871|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
58872|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
58873|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
58874|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
58875|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
58876|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
58877|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
58878|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
58879|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
58880|NCT02023099|E4|Reported Event|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
58881|NCT02023099|E3|Reported Event|Substudy 1, Arm B: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
58882|NCT02023099|E2|Reported Event|Substudy 1, Arm B: DB Placebo|DB placebo QD for 12 weeks in participants without cirrhosis
89798|NCT01843374|O2|Outcome|PLACEBO|Placebo.
58883|NCT02023099|E1|Reported Event|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis.
58884|NCT02022670|B4|Baseline|Total|Total of all reporting groups
58885|NCT02022670|B3|Baseline|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58886|NCT02022670|B2|Baseline|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58887|NCT02022670|B1|Baseline|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
58888|NCT02022670|P3|Participant Flow|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58889|NCT02022670|P2|Participant Flow|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58890|NCT02022670|P1|Participant Flow|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
58891|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58892|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58893|NCT02022670|O1|Outcome|Placebo|"inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks
Placebo: Sugar pill manufactured to mimic sodium nitrite capsules"
58894|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58895|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58896|NCT02022670|O1|Outcome|Placebo|"inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks
Placebo: Sugar pill manufactured to mimic sodium nitrite capsules"
58897|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58898|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58899|NCT02022670|O1|Outcome|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
58900|NCT02022670|E3|Reported Event|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58901|NCT02022670|E2|Reported Event|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite: 80 mg/d or 160 mg/d"
58902|NCT02022670|E1|Reported Event|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
58903|NCT02022085|B1|Baseline|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58904|NCT02022085|P1|Participant Flow|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58905|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58906|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58989|NCT02021461|E1|Reported Event|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
58926|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
59525|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
58907|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58908|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58909|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58910|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58911|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58912|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58913|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58914|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58915|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58916|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58917|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58918|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58919|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58920|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58921|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58922|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58923|NCT02022085|E1|Reported Event|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
58924|NCT02022020|B1|Baseline|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
58925|NCT02022020|P1|Participant Flow|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
58990|NCT02021331|B3|Baseline|Total|Total of all reporting groups
58927|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
58928|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
58929|NCT02022020|E1|Reported Event|Dabigatran (Pradax® in Canada; Pradaxa® in the United States|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
58930|NCT02022007|B4|Baseline|Total|Total of all reporting groups
58931|NCT02022007|B3|Baseline|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58932|NCT02022007|B2|Baseline|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58933|NCT02022007|B1|Baseline|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58934|NCT02022007|P3|Participant Flow|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58935|NCT02022007|P2|Participant Flow|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58936|NCT02022007|P1|Participant Flow|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58937|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58938|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58939|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58940|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58941|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58942|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58943|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58944|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58945|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58946|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58947|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58948|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58949|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58950|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58951|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58952|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58953|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58954|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58955|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
63663|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select OHN variables
58956|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58957|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58958|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58959|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58960|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58961|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58962|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58963|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58964|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58965|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58966|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58967|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58968|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58969|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58970|NCT02022007|O3|Outcome|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58971|NCT02022007|O2|Outcome|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58972|NCT02022007|O1|Outcome|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58973|NCT02022007|E3|Reported Event|Saxagliptin-Metformin XR|"Saxagliptin-Metformin XR (combination pill)
5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks
Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
58974|NCT02022007|E2|Reported Event|Saxagliptin|"Saxagliptin 5 mg QD for 16 weeks
Saxagliptin: Start 1 pill (5 mg)) for 3 weeks
Remain at 1 pill (5mg dose) for remainder of study"
58975|NCT02022007|E1|Reported Event|Metformin XR|"Metformin 2000 mg QD for 16 weeks
Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
58976|NCT02021812|B1|Baseline|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
58977|NCT02021812|P1|Participant Flow|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
58978|NCT02021812|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
58979|NCT02021812|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
58980|NCT02021812|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
58981|NCT02021812|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
58982|NCT02021812|O1|Outcome|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
58983|NCT02021812|E1|Reported Event|Branched TAG® Device|"Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device"
58984|NCT02021461|B1|Baseline|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
58985|NCT02021461|P1|Participant Flow|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
58986|NCT02021461|O3|Outcome|ESL Tutti-Frutti Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
ESL Tutti-Frutti taste"
58987|NCT02021461|O2|Outcome|ESL Grape Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
ESL Grape taste"
58988|NCT02021461|O1|Outcome|ESL Banana Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
ESL Banana taste"
58991|NCT02021331|B2|Baseline|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization"
58992|NCT02021331|B1|Baseline|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization"
58993|NCT02021331|P2|Participant Flow|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization"
58994|NCT02021331|P1|Participant Flow|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization"
58995|NCT02021331|O2|Outcome|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization"
58996|NCT02021331|O1|Outcome|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization"
58997|NCT02021331|O2|Outcome|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization"
58998|NCT02021331|O1|Outcome|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization"
58999|NCT02021331|O2|Outcome|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization"
59000|NCT02021331|O1|Outcome|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization"
59001|NCT02021331|E2|Reported Event|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization"
59002|NCT02021331|E1|Reported Event|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization"
59003|NCT02021071|B3|Baseline|Total|Total of all reporting groups
59004|NCT02021071|B2|Baseline|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning
XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
59005|NCT02021071|B1|Baseline|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data)
XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
59006|NCT02021071|P2|Participant Flow|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning
XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
59007|NCT02021071|P1|Participant Flow|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).
XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
59008|NCT02021071|O2|Outcome|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning
XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
59009|NCT02021071|O1|Outcome|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data)
XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
59010|NCT02021071|O1|Outcome|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning
XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
59011|NCT02021071|E2|Reported Event|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning
XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
59012|NCT02021071|E1|Reported Event|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).
XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
59013|NCT02020941|B1|Baseline|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.
MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
carfilzomib: Given IV
dexamethasone: Given IV or PO
laboratory biomarker analysis: Correlative studies"
102356|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
59079|NCT02020304|B1|Baseline|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)
combined spinal epidural: Combined Spinal Epidural"
63664|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select OHN variables
59014|NCT02020941|P1|Participant Flow|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.
MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
carfilzomib: Given IV
dexamethasone: Given IV or PO
laboratory biomarker analysis: Correlative studies"
59015|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.
MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
carfilzomib: Given IV
dexamethasone: Given IV or PO
laboratory biomarker analysis: Correlative studies"
59016|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.
MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
carfilzomib: Given IV
dexamethasone: Given IV or PO
laboratory biomarker analysis: Correlative studies"
59017|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.
MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
carfilzomib: Given IV
dexamethasone: Given IV or PO
laboratory biomarker analysis: Correlative studies"
59018|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.
MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
carfilzomib: Given IV
dexamethasone: Given IV or PO
laboratory biomarker analysis: Correlative studies"
59019|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.
MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
carfilzomib: Given IV
dexamethasone: Given IV or PO
laboratory biomarker analysis: Correlative studies"
59020|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.
MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
carfilzomib: Given IV
dexamethasone: Given IV or PO
laboratory biomarker analysis: Correlative studies"
59021|NCT02020941|E1|Reported Event|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.
MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
carfilzomib: Given IV
dexamethasone: Given IV or PO
laboratory biomarker analysis: Correlative studies"
59022|NCT02020863|B1|Baseline|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.
Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
59023|NCT02020863|P1|Participant Flow|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.
Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
59024|NCT02020863|O1|Outcome|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.
Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
59025|NCT02020863|E1|Reported Event|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.
Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
59026|NCT02020577|B3|Baseline|Total|Total of all reporting groups
59027|NCT02020577|B2|Baseline|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59028|NCT02020577|B1|Baseline|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59029|NCT02020577|P2|Participant Flow|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59030|NCT02020577|P1|Participant Flow|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59031|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59032|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59033|NCT02020577|O3|Outcome|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
59034|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59035|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59036|NCT02020577|O3|Outcome|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
59037|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59038|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59039|NCT02020577|O3|Outcome|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
59040|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59041|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59042|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59043|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59044|NCT02020577|O3|Outcome|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
59045|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59078|NCT02020304|B2|Baseline|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)
combined spinal epidural: Combined Spinal Epidural"
60132|NCT02013687|E2|Reported Event|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
59046|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59047|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59048|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59049|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59050|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59051|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59052|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59053|NCT02020577|E3|Reported Event|All Patients|Patients who were administered Afatinib 30mg+cetuximab 250 mg/m² plus the patients who were administered Afatinib 40mg+cetuximab 250 mg/m².
59054|NCT02020577|E2|Reported Event|Afatinib 40mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400 mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59055|NCT02020577|E1|Reported Event|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
59056|NCT02020512|B1|Baseline|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
59057|NCT02020512|P1|Participant Flow|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
59058|NCT02020512|O1|Outcome|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
59059|NCT02020512|E1|Reported Event|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
59060|NCT02020369|B3|Baseline|Total|Total of all reporting groups
59061|NCT02020369|B2|Baseline|FVIIa 225 µg/kg First, Then 75 µg/kg|Coagulation Factor VIIa (Recombinant): First Intervention (3 months), Second Intervention (3 months), continue cycle until end of study.
59062|NCT02020369|B1|Baseline|FVIIa 75 µg/kg First, Then 225 µg/kg|Coagulation Factor VIIa (Recombinant): First Intervention (3 months), Second Intervention (3 months), continue cycle until end of study.
59063|NCT02020369|P2|Participant Flow|FVIIa: 75 µg/kg First, Then 225 µg/kg|Coagulation Factor VIIa (Recombinant): Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
59064|NCT02020369|P1|Participant Flow|FVIIa: 225 µg/kg First, Then 75 µg/kg|Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
59065|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
59066|NCT02020369|O1|Outcome|FVIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
59067|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
59068|NCT02020369|O1|Outcome|Factor VIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
59069|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
59070|NCT02020369|O1|Outcome|FVIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
59071|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
59072|NCT02020369|O1|Outcome|FVIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
59073|NCT02020369|O2|Outcome|FVIIa 225µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
59074|NCT02020369|O1|Outcome|FVIIa 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
59075|NCT02020369|E2|Reported Event|Coagulation Factor VIIa (Recombinant): 225 µg/kg|"Coagulation Factor VIIa (Recombinant) : 225 µg/kg for 3 months
Coagulation Factor VIIa (Recombinant): A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX"
59076|NCT02020369|E1|Reported Event|Coagulation Factor VIIa (Recombinant): 75 µg/kg|"Coagulation Factor VIIa (Recombinant): 75 µg/kg for 3 months
Coagulation Factor VIIa (Recombinant): A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX"
59077|NCT02020304|B3|Baseline|Total|Total of all reporting groups
59654|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59080|NCT02020304|P2|Participant Flow|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59081|NCT02020304|P1|Participant Flow|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59082|NCT02020304|O2|Outcome|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59083|NCT02020304|O1|Outcome|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59084|NCT02020304|O2|Outcome|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59085|NCT02020304|O1|Outcome|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59086|NCT02020304|O2|Outcome|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59087|NCT02020304|O1|Outcome|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59088|NCT02020304|O2|Outcome|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59089|NCT02020304|O1|Outcome|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59090|NCT02020304|O2|Outcome|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59091|NCT02020304|O1|Outcome|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59092|NCT02020304|E2|Reported Event|Refrigerated Temperature|"refrigerated temperature combined spinal epidural dose (~<43 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59093|NCT02020304|E1|Reported Event|Room Temperature|"room temperature combined spinal epidural dose (60-75 degrees F)
combined spinal epidural: Combined Spinal Epidural"
59094|NCT02020135|B3|Baseline|Total|Total of all reporting groups
59095|NCT02020135|B2|Baseline|PSMA ADC Chemotherapy-naive|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
59096|NCT02020135|B1|Baseline|PSMA ADC Chemotherapy-experienced|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
59097|NCT02020135|P1|Participant Flow|Arm 1: PSMA ADC|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
59098|NCT02020135|O2|Outcome|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
59099|NCT02020135|O1|Outcome|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
59100|NCT02020135|O2|Outcome|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
59101|NCT02020135|O1|Outcome|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
59295|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59102|NCT02020135|O2|Outcome|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
59103|NCT02020135|O1|Outcome|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
59104|NCT02020135|E2|Reported Event|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
59105|NCT02020135|E1|Reported Event|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
59106|NCT02020031|B3|Baseline|Total|Total of all reporting groups
59107|NCT02020031|B2|Baseline|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
59108|NCT02020031|B1|Baseline|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
59109|NCT02020031|P2|Participant Flow|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
59110|NCT02020031|P1|Participant Flow|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
59111|NCT02020031|O2|Outcome|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
59112|NCT02020031|O1|Outcome|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
59113|NCT02020031|O2|Outcome|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
59114|NCT02020031|O1|Outcome|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
59115|NCT02020031|E2|Reported Event|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
59116|NCT02020031|E1|Reported Event|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
59117|NCT02019563|B3|Baseline|Total|Total of all reporting groups
59118|NCT02019563|B2|Baseline|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.
Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
59119|NCT02019563|B1|Baseline|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
59120|NCT02019563|P2|Participant Flow|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.
Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
59121|NCT02019563|P1|Participant Flow|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
59122|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.
Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
60133|NCT02013687|E1|Reported Event|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
59123|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
59124|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.
RCT Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
59125|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
MTA/FS pulpotomy Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
59126|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.
RCT Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
59127|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
MTA/FS pulpotomy Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
59128|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.
Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
59129|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
59130|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.
Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
59131|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
59132|NCT02019563|E2|Reported Event|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.
Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
59133|NCT02019563|E1|Reported Event|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
59134|NCT02019550|B3|Baseline|Total|Total of all reporting groups
59135|NCT02019550|B2|Baseline|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59136|NCT02019550|B1|Baseline|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59137|NCT02019550|P2|Participant Flow|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59138|NCT02019550|P1|Participant Flow|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59139|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59140|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59141|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59142|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59143|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59144|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59145|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59146|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59147|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59148|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59149|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59150|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59151|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59152|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59153|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59154|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59155|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59156|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59157|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59180|NCT02018809|P4|Participant Flow|Usual Care|"Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59158|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59159|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59160|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59161|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59162|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59163|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59164|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59165|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59166|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59167|NCT02019550|O2|Outcome|Rebiject II|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.
59168|NCT02019550|O1|Outcome|Rebif Rebidose|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.
59169|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59170|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59171|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
59172|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
59173|NCT02019550|E2|Reported Event|Rebiject II|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.
59174|NCT02019550|E1|Reported Event|Rebif Rebidose|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.
59175|NCT02018809|B5|Baseline|Total|Total of all reporting groups
59176|NCT02018809|B4|Baseline|Usual Care|"Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59177|NCT02018809|B3|Baseline|MAP Missed Doses|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59178|NCT02018809|B2|Baseline|MAP Weekly Notification|"The subject’s MAP receives weekly about how often the subject took statin during previous week.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59179|NCT02018809|B1|Baseline|MAP Daily Notification|"The subject’s MAP receives daily notification about whether subject took statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59181|NCT02018809|P3|Participant Flow|MAP Missed Doses|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59182|NCT02018809|P2|Participant Flow|MAP Weekly Notification|"The subject’s MAP receives weekly about how often the subject took statin during previous week.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59183|NCT02018809|P1|Participant Flow|MAP Daily Notification|"The subject’s MAP receives daily notification about whether subject took statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59184|NCT02018809|O4|Outcome|Usual Care|"Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59185|NCT02018809|O3|Outcome|MAP Missed Doses|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59186|NCT02018809|O2|Outcome|MAP Weekly Notification|"The subject’s MAP receives weekly about how often the subject took statin during previous week.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59187|NCT02018809|O1|Outcome|MAP Daily Notification|"The subject’s MAP receives daily notification about whether subject took statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59188|NCT02018809|O4|Outcome|Usual Care|"Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59189|NCT02018809|O3|Outcome|MAP Missed Doses|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59190|NCT02018809|O2|Outcome|MAP Weekly Notification|"The subject’s MAP receives weekly about how often the subject took statin during previous week.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59191|NCT02018809|O1|Outcome|MAP Daily Notification|"The subject’s MAP receives daily notification about whether subject took statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59192|NCT02018809|E4|Reported Event|Usual Care|"Usual care with GlowCap.
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59193|NCT02018809|E3|Reported Event|MAP Missed Doses|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59194|NCT02018809|E2|Reported Event|MAP Weekly Notification|"The subject’s MAP receives weekly about how often the subject took statin during previous week.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59195|NCT02018809|E1|Reported Event|MAP Daily Notification|"The subject’s MAP receives daily notification about whether subject took statin.
Medication Adherence Partner
Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
59196|NCT02017574|B3|Baseline|Total|Total of all reporting groups
59197|NCT02017574|B2|Baseline|Control|"Receives detailed feedback about task performance during learning
Reaching Task: Learn a reaching task that requires coordination of the arm segments"
59198|NCT02017574|B1|Baseline|Implicit Group|"Receives little feedback about task performance during learning
Reaching Task: Learn a reaching task that requires coordination of the arm segments"
59199|NCT02017574|P2|Participant Flow|Control|"Receives detailed feedback about task performance during learning
Reaching Task: Learn a reaching task that requires coordination of the arm segments"
59200|NCT02017574|P1|Participant Flow|Implicit Group|"Receives little feedback about task performance during learning
Reaching Task: Learn a reaching task that requires coordination of the arm segments"
59201|NCT02017574|O2|Outcome|Control|"Receives detailed feedback about task performance during learning
Reaching Task: Learn a reaching task that requires coordination of the arm segments"
59202|NCT02017574|O1|Outcome|Implicit Group|"Receives little feedback about task performance during learning
Reaching Task: Learn a reaching task that requires coordination of the arm segments"
59203|NCT02017574|O2|Outcome|Control|"Receives detailed feedback about task performance during learning
Reaching Task: Learn a reaching task that requires coordination of the arm segments"
59204|NCT02017574|O1|Outcome|Implicit Group|"Receives little feedback about task performance during learning
Reaching Task: Learn a reaching task that requires coordination of the arm segments"
59205|NCT02017574|E2|Reported Event|Control|"Receives detailed feedback about task performance during learning
Reaching Task: Learn a reaching task that requires coordination of the arm segments"
59206|NCT02017574|E1|Reported Event|Implicit Group|"Receives little feedback about task performance during learning
Reaching Task: Learn a reaching task that requires coordination of the arm segments"
59207|NCT02017093|B3|Baseline|Total|Total of all reporting groups
59208|NCT02017093|B2|Baseline|Control|Patients admitted to rehabilitation center after a stroke.
59209|NCT02017093|B1|Baseline|Study|Patients admitted to rehabilitation center after a stroke.
59210|NCT02017093|P2|Participant Flow|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
59211|NCT02017093|P1|Participant Flow|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
59212|NCT02017093|O2|Outcome|Control Group|"Training of the upper extremity, using a robotic devise without forces applied and traditional therapy.
control treatment: Patients underwent upper extremity robotic training without the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions."
59213|NCT02017093|O1|Outcome|Error Enhancement|"Training of the upper extremity, using a robotic devise with error enhanced forces and traditional therapy.
Error Enhancement: Patients underwent upper extremity robotic training with the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions."
59214|NCT02017093|O2|Outcome|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
59215|NCT02017093|O1|Outcome|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
59216|NCT02017093|E2|Reported Event|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
59217|NCT02017093|E1|Reported Event|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
59218|NCT02017015|B1|Baseline|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
59219|NCT02017015|P1|Participant Flow|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 by IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
59220|NCT02017015|O1|Outcome|Nab-paclitaxel With Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
59221|NCT02017015|O1|Outcome|Nab-paclitaxel With Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
59222|NCT02017015|O1|Outcome|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
59223|NCT02017015|O1|Outcome|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
59224|NCT02017015|E1|Reported Event|ABI-007/Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
59225|NCT02016963|B1|Baseline|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59226|NCT02016963|P1|Participant Flow|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
102357|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
59227|NCT02016963|O1|Outcome|Raxibacumab IV|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59228|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59229|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59230|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59231|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59232|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59233|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59234|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59235|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59236|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59237|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59238|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59239|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59240|NCT02016963|E1|Reported Event|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
59241|NCT02016690|B1|Baseline|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
59242|NCT02016690|P1|Participant Flow|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
59243|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
59244|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
59245|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
59246|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
59247|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
59248|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
59249|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
59250|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
59251|NCT02016690|E1|Reported Event|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
59252|NCT02016625|B3|Baseline|Total|Total of all reporting groups
59253|NCT02016625|B2|Baseline|Tacrolimus / Tacrolimus + Faldaprevir|fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
59254|NCT02016625|B1|Baseline|Cyclosporine / Cyclosporine + Faldaprevir|fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
59294|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59255|NCT02016625|P2|Participant Flow|Tacrolimus / Tacrolimus + Faldaprevir|fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
59256|NCT02016625|P1|Participant Flow|Cyclosporine / Cyclosporine + Faldaprevir|fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
59257|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
59258|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7 [followed by tac treatment] in period 2.
59259|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
59260|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7 [followed by tac treatment] in period 2.
59261|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
59262|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by tac treatment] in period 2
59263|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1, treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
59264|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
59265|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
59266|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
59267|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
59268|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
59269|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
59270|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
59271|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
59272|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
59273|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
59274|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
59275|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
59276|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
59277|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
59278|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
59279|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
59280|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
59281|NCT02016625|E6|Reported Event|Tac+FDV|Tacrolimus 0.5 mg + FDV 120 mg
59282|NCT02016625|E5|Reported Event|Cyclo+FDV|Cyclosporine 50 mg + FDV 120 mg
59283|NCT02016625|E4|Reported Event|FDV (ff Tac)|FDV 120 mg (followed by tacrolimus)
59284|NCT02016625|E3|Reported Event|FDV (ff Cyclo)|FDV 120 mg (followed by cyclosporine)
59285|NCT02016625|E2|Reported Event|Tacrolimus (Tac)|Tacrolimus (tac) 0.5 mg
59286|NCT02016625|E1|Reported Event|Cyclosporine (Cyclo)|Cyclosporine (cyclo) 50 mg
59287|NCT02016482|B3|Baseline|Total|Total of all reporting groups
59288|NCT02016482|B2|Baseline|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59289|NCT02016482|B1|Baseline|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59290|NCT02016482|P2|Participant Flow|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59291|NCT02016482|P1|Participant Flow|Placebo|Period A: Placebo subcutaneous every other week (sc eow) for 25 weeks. Period B: Adalimumab (ADA) 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59292|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59293|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
61720|NCT02005029|O2|Outcome|Placebo|Mean time for right hand after placebo
59296|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59297|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59298|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59299|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59300|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59301|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59302|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59303|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59304|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59305|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59306|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59307|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59308|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59309|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59310|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59311|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59312|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59313|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59314|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59315|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59316|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59317|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59318|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59319|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59320|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59321|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59322|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59323|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59324|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59325|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59326|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59327|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59328|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59329|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59330|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59331|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59332|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59333|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59334|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59335|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59336|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59337|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59338|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59339|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59340|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59341|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59342|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59343|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59344|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59345|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59346|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59347|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59348|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59349|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59350|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59351|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59352|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59353|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59354|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59355|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59356|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59357|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59358|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59359|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59360|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59361|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59362|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59363|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59364|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59365|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59366|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59367|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59368|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59369|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59370|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59371|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59372|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59373|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59374|NCT02016482|E4|Reported Event|Adalimumab EOW/Adalimumab EOW (Period B)|Following Period A (ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg), placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59375|NCT02016482|E3|Reported Event|Placebo/Adalimumab EOW (Period B)|Following Period A (placebo sc eow for 25 weeks), ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59376|NCT02016482|E2|Reported Event|Adalimumab EOW (Period A)|ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg.
59377|NCT02016482|E1|Reported Event|Placebo (Period A)|Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
59378|NCT02016170|B4|Baseline|Total|Total of all reporting groups
59379|NCT02016170|B3|Baseline|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
59380|NCT02016170|B2|Baseline|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
59381|NCT02016170|B1|Baseline|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
59382|NCT02016170|P3|Participant Flow|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
59383|NCT02016170|P2|Participant Flow|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
59384|NCT02016170|P1|Participant Flow|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
59385|NCT02016170|O2|Outcome|Prasugrel|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7 days
59386|NCT02016170|O1|Outcome|Ticagrelor|Patients switched to ticagrelor (two arms combined) with or without a loading dose and receiving ticagrelor 90 mg bid for 7 days.
59387|NCT02016170|O2|Outcome|Prasugrel|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7 days
59388|NCT02016170|O1|Outcome|Ticagrelor|Patients switched to ticagrelor (two arms combined) with or without a loading dose and receiving ticagrelor 90 mg bid for 7 days.
59389|NCT02016170|E3|Reported Event|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
59390|NCT02016170|E2|Reported Event|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
59391|NCT02016170|E1|Reported Event|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
59392|NCT02016105|B3|Baseline|Total|Total of all reporting groups
59393|NCT02016105|B2|Baseline|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59394|NCT02016105|B1|Baseline|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59395|NCT02016105|P6|Participant Flow|GP2017 Adalimumab Continued|GP2017 subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).
59396|NCT02016105|P5|Participant Flow|GP2017 Adalimumab Switched|Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).
59397|NCT02016105|P4|Participant Flow|Humira ® Adalimumab Continued|Humira ® subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).
59398|NCT02016105|P3|Participant Flow|Humira ® Adalimumab Switched|Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).
59399|NCT02016105|P2|Participant Flow|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59515|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59521|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59400|NCT02016105|P1|Participant Flow|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59401|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59402|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59403|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59404|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59405|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59406|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59407|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59408|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59409|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59410|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59411|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59412|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59413|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59414|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59415|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59416|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59417|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59418|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59419|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59420|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59421|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59422|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59423|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59424|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59425|NCT02016105|O2|Outcome|Humira ® Adalimumab|"Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.
Humira ® Adalimumab"
59426|NCT02016105|O1|Outcome|GP2017 Adalimumab|"Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.
GP2017 Adalimumab"
59427|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59428|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59429|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59430|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59431|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59432|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59433|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59434|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59435|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59436|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59437|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59438|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59439|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59440|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59441|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59442|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
59443|NCT02016105|E4|Reported Event|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59516|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
59444|NCT02016105|E3|Reported Event|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59445|NCT02016105|E2|Reported Event|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
59446|NCT02016105|E1|Reported Event|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).
Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
59447|NCT02015910|B3|Baseline|Total|Total of all reporting groups
59448|NCT02015910|B2|Baseline|Placebo|"Placebo
Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
59449|NCT02015910|B1|Baseline|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks
Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
59450|NCT02015910|P2|Participant Flow|Placebo|"Placebo
Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
59451|NCT02015910|P1|Participant Flow|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks
Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
59452|NCT02015910|O2|Outcome|Placebo|"Placebo
Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
59453|NCT02015910|O1|Outcome|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks
Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
59454|NCT02015910|E2|Reported Event|Placebo|"Placebo
Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
59455|NCT02015910|E1|Reported Event|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks
Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
59456|NCT02015793|B3|Baseline|Total|Total of all reporting groups
59457|NCT02015793|B2|Baseline|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59458|NCT02015793|B1|Baseline|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59459|NCT02015793|P2|Participant Flow|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59460|NCT02015793|P1|Participant Flow|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59461|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59462|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59463|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59464|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59465|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59466|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59467|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59468|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59469|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59470|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59471|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59472|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59473|NCT02015793|O4|Outcome|Standard Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
59474|NCT02015793|O3|Outcome|Low Induction Dose (Open-label Extension Period)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
59475|NCT02015793|O2|Outcome|Standard Induction Dose (Double-blind Period)|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59476|NCT02015793|O1|Outcome|Low Induction Dose (Double-blind Period)|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59477|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59478|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59479|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59480|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59481|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59482|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59483|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59484|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59485|NCT02015793|E4|Reported Event|Standard Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
59486|NCT02015793|E3|Reported Event|Low Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
59487|NCT02015793|E2|Reported Event|Standard Induction Dose (Double-blind)|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
59488|NCT02015793|E1|Reported Event|Low Induction Dose (Double-blind)|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
59489|NCT02015676|B4|Baseline|Total|Total of all reporting groups
59490|NCT02015676|B3|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase II and II|During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59491|NCT02015676|B2|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59492|NCT02015676|B1|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase I|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, from Week 1. If no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
59493|NCT02015676|P3|Participant Flow|Trastuzumab Doxorubicin, Paclitaxel; Phase I and Phase II|During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59494|NCT02015676|P2|Participant Flow|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59517|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59518|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
59519|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
102358|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
59495|NCT02015676|P1|Participant Flow|Trastuzumab, Doxorubicin, Paclitaxel; Phase I|Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg per square meter (mg/m^2), IV, once every 3 weeks, from Week 1. If no dose-limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
59496|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59497|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59498|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59499|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59500|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59501|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59502|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59503|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59504|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59505|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59506|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59507|NCT02015676|E1|Reported Event|Trastuzumab, Doxorubicin, Paclitaxel; Phase I & II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
59508|NCT02015663|B3|Baseline|Total|Total of all reporting groups
59509|NCT02015663|B2|Baseline|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59510|NCT02015663|B1|Baseline|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
59511|NCT02015663|P2|Participant Flow|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59512|NCT02015663|P1|Participant Flow|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
59513|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59514|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
61721|NCT02005029|O1|Outcome|Erythromycin|Mean time for right hand after erythromycin
59526|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
59527|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59528|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
59529|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59530|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
59531|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59532|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
59533|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59534|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
59535|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59536|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
59537|NCT02015663|E3|Reported Event|Total Events|
59538|NCT02015663|E2|Reported Event|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
59539|NCT02015663|E1|Reported Event|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
59540|NCT02015546|B4|Baseline|Total|Total of all reporting groups
59541|NCT02015546|B3|Baseline|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59542|NCT02015546|B2|Baseline|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59543|NCT02015546|B1|Baseline|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59544|NCT02015546|P3|Participant Flow|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59545|NCT02015546|P2|Participant Flow|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59546|NCT02015546|P1|Participant Flow|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59547|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59548|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59549|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59550|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59551|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59552|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59553|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59554|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59555|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59556|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59557|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59558|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59559|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59685|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59560|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59561|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59562|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
60137|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
59563|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59564|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59565|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59566|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59567|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59568|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59569|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59570|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59571|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59572|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59573|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59574|NCT02015546|E3|Reported Event|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59575|NCT02015546|E2|Reported Event|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59576|NCT02015546|E1|Reported Event|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
59577|NCT02015481|B1|Baseline|Cabaletta 30gr.|"weekly IV of Cabaletta 30gr.
Cabaletta"
59578|NCT02015481|P1|Participant Flow|Cabaletta 30gr|"weekly IV of Cabaletta 30gr
Cabaletta"
59579|NCT02015481|O1|Outcome|Cabaletta 30gr|"weekly IV of Cabaletta 30gr
Cabaletta"
59580|NCT02015481|O1|Outcome|Cabaletta 30gr|"weekly IV of Cabaletta 30gr
Cabaletta"
59581|NCT02015481|O1|Outcome|Cabaletta 30gr|"weekly IV of Cabaletta 30gr
Cabaletta"
59582|NCT02015481|O1|Outcome|Cabaletta 30gr.|"weekly IV of Cabaletta 30gr.
Cabaletta"
59583|NCT02015481|E1|Reported Event|Cabaletta 30gr|"weekly IV of Cabaletta 30gr
Cabaletta"
59584|NCT02015234|B3|Baseline|Total|Total of all reporting groups
59585|NCT02015234|B2|Baseline|TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg|"1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months
TNX-102 SL: TNX-102 2.8 mg SL taken daily at bedtime."
59586|NCT02015234|B1|Baseline|Placebo - TNX-102 SL 2.8 mg|"1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months
TNX-102 SL: TNX-102 2.8 mg SL taken daily at bedtime."
59587|NCT02015234|P2|Participant Flow|TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202) as well as the open-label study, for a total treatment duration of up to 15 months.
59588|NCT02015234|P1|Participant Flow|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
59589|NCT02015234|O2|Outcome|TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
59590|NCT02015234|O1|Outcome|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
59591|NCT02015234|O2|Outcome|TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
59592|NCT02015234|O1|Outcome|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
59593|NCT02015234|O2|Outcome|TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
59594|NCT02015234|O1|Outcome|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
59595|NCT02015234|O2|Outcome|TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202) as well as the open-label study, for a total treatment duration of up to 15 months.
59596|NCT02015234|O1|Outcome|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
59597|NCT02015234|E2|Reported Event|TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg|These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
59625|NCT02015195|O4|Outcome|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Lidocaine (4%)
No treatment"
59598|NCT02015234|E1|Reported Event|Placebo - TNX-102 SL 2.8 mg|These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
59599|NCT02015221|B3|Baseline|Total|Total of all reporting groups
59600|NCT02015221|B2|Baseline|Standard Compression Garments|Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
59601|NCT02015221|B1|Baseline|ACTitouch|ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
59602|NCT02015221|P2|Participant Flow|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
59603|NCT02015221|P1|Participant Flow|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
59604|NCT02015221|O2|Outcome|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
59605|NCT02015221|O1|Outcome|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
59606|NCT02015221|E2|Reported Event|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
59607|NCT02015221|E1|Reported Event|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
59608|NCT02015195|B8|Baseline|Total|Total of all reporting groups
59609|NCT02015195|B7|Baseline|Heated Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Heated Tap Water (40 degrees Celsius)
No treatment
8 males, 8 females treated"
59610|NCT02015195|B6|Baseline|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Isopropyl Alcohol (70%)
No treatment
8 makes, 8 females treated"
59611|NCT02015195|B5|Baseline|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Lidocaine (4%)
No treatment
10 males, 6 females treated"
59612|NCT02015195|B4|Baseline|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Ammonia (10%)
No treatment
1 female treated; adverse local skin reaction; study arm therefore withdrawn"
59613|NCT02015195|B3|Baseline|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Papain Slurry (70%)
No treatment
9 males, 7 females treated"
59614|NCT02015195|B2|Baseline|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Sodium Bicarbonate Slurry (50%)
No treatment
8 males, 8 females treated"
59615|NCT02015195|B1|Baseline|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Acetic Acid (5%)
No treatment
11 males, 5 females treated"
59616|NCT02015195|P7|Participant Flow|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Hot Tap Water (40 degrees Celsius)
No treatment
The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
59617|NCT02015195|P6|Participant Flow|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Isopropyl Alcohol (70%)
The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment).
No treatment"
59618|NCT02015195|P5|Participant Flow|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Lidocaine (4%)
No treatment
The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
59619|NCT02015195|P4|Participant Flow|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Ammonia (10%)
No treatment
The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
59620|NCT02015195|P3|Participant Flow|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Papain Slurry (70%)
No treatment
The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
59621|NCT02015195|P2|Participant Flow|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Sodium Bicarbonate Slurry (50%)
No treatment
The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
59622|NCT02015195|P1|Participant Flow|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Acetic Acid (5%)
No treatment
The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
59623|NCT02015195|O6|Outcome|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Hot Tap Water (40 degrees Celsius)
No treatment"
59624|NCT02015195|O5|Outcome|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Isopropyl Alcohol (70%)
No treatment"
63665|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select OHN variables
59626|NCT02015195|O3|Outcome|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Papain Slurry (70%)
No treatment"
59627|NCT02015195|O2|Outcome|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Sodium Bicarbonate Slurry (50%)
No treatment"
59628|NCT02015195|O1|Outcome|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Acetic Acid (5%)
No treatment"
59629|NCT02015195|O6|Outcome|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Hot Tap Water (40 degrees Celsius)
No treatment"
59630|NCT02015195|O5|Outcome|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Isopropyl Alcohol (70%)
No treatment"
59631|NCT02015195|O4|Outcome|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Lidocaine (4%)
No treatment"
59632|NCT02015195|O3|Outcome|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Papain Slurry (70%)
No treatment"
59633|NCT02015195|O2|Outcome|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Sodium Bicarbonate Slurry (50%)
No treatment"
59634|NCT02015195|O1|Outcome|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Acetic Acid (5%)
No treatment"
59635|NCT02015195|E7|Reported Event|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Hot Tap Water (40 degrees Celsius)
No treatment"
59636|NCT02015195|E6|Reported Event|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Isopropyl Alcohol (70%)
No treatment"
59637|NCT02015195|E5|Reported Event|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Lidocaine (4%)
No treatment"
59638|NCT02015195|E4|Reported Event|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Ammonia (10%)
No treatment
The first patient treated had an adverse local skin reaction, so this study arm was discontinued"
59639|NCT02015195|E3|Reported Event|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Papain Slurry (70%)
No treatment"
59640|NCT02015195|E2|Reported Event|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Sodium Bicarbonate Slurry (50%)
No treatment"
59641|NCT02015195|E1|Reported Event|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes
Acetic Acid (5%)
No treatment"
59642|NCT02014584|B3|Baseline|Total|Total of all reporting groups
59643|NCT02014584|B2|Baseline|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59644|NCT02014584|B1|Baseline|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59645|NCT02014584|P6|Participant Flow|Targeted F/U: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study drug administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
59646|NCT02014584|P5|Participant Flow|Targeted F/U: Placebo (DB)/Dutasteride 0.5 mg (OL)|Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study treatment administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
59647|NCT02014584|P4|Participant Flow|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59648|NCT02014584|P3|Participant Flow|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59649|NCT02014584|P2|Participant Flow|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59650|NCT02014584|P1|Participant Flow|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59651|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59652|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59653|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
61722|NCT02005029|O2|Outcome|Placebo|Area under the curve 0-4 hours for plasma levodopa after placebo
59655|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59774|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59656|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59657|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59658|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59659|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59660|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59661|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59662|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59663|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59664|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59665|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59666|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59667|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59668|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59669|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59670|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59671|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59672|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59673|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59674|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59675|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59676|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59677|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59678|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59679|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59680|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59681|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59682|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59683|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59684|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59686|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59775|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59687|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59688|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59689|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59690|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59691|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59692|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59693|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59694|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59695|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59696|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59697|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59698|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59699|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59700|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59701|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59702|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59703|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59704|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59705|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59706|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59707|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59708|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59709|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59710|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59711|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59712|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59713|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59714|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59715|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59773|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
63666|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select OHN variables
59716|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59717|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59718|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59719|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59720|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59721|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59722|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59723|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59724|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59725|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59726|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59727|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59728|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59729|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59730|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59731|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59732|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59733|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59734|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59735|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59736|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59737|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59738|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59739|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59740|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59741|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59742|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59743|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59744|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59745|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59746|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59747|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59748|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59749|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59750|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59751|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59752|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59753|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59754|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59755|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59756|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59757|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
59758|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
59759|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
59760|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
59761|NCT02014584|E5|Reported Event|Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|
59762|NCT02014584|E4|Reported Event|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|
59763|NCT02014584|E3|Reported Event|Placebo (DB)/Dutasteride 0.5 mg (OL)|
59764|NCT02014584|E2|Reported Event|Dutasteride 0.5 mg (DB)|
59765|NCT02014584|E1|Reported Event|Placebo (DB)|
59766|NCT02014480|B1|Baseline|UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|All participants received one of the following three treatments in one of three treatment periods QD from the DPI for 14 days: UMEC 62.5 µg inhalation powder; VI 25 µg inhalation powder; and UMEC/VI 62.5/25 µg inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg; (2) VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg; (3) UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg; (4) UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg; (5) VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg; (6) UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg. The three treatment periods were separated by a washout period of 10 to 14 days.
59767|NCT02014480|P6|Participant Flow|Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg|Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
59768|NCT02014480|P5|Participant Flow|Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg|Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
59769|NCT02014480|P4|Participant Flow|Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg|Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
59770|NCT02014480|P3|Participant Flow|Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg|Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
59771|NCT02014480|P2|Participant Flow|Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg|Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
59772|NCT02014480|P1|Participant Flow|Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol trifenatate (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
59776|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59777|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59778|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59779|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59780|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59781|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59782|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59783|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59784|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59785|NCT02014480|E3|Reported Event|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59786|NCT02014480|E2|Reported Event|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59787|NCT02014480|E1|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
59788|NCT02014467|B3|Baseline|Total|Total of all reporting groups
59789|NCT02014467|B2|Baseline|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59790|NCT02014467|B1|Baseline|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59791|NCT02014467|P2|Participant Flow|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase.Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59792|NCT02014467|P1|Participant Flow|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59793|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59794|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59795|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59796|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59797|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59798|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59799|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59800|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59801|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
60135|NCT02013622|P1|Participant Flow|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 milligram per day (mg/day) to 4 mg/day, once daily (QD) for 16 Weeks.
59802|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59803|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59804|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59805|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59806|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59807|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59808|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59809|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59810|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59811|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59812|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59813|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59814|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59815|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59816|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59817|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59818|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59819|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59820|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59821|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59822|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59823|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59874|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59847|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59824|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59825|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59826|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59827|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59828|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59829|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59830|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59831|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59832|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59833|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59834|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59835|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59836|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59837|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59838|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59839|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59840|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59841|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59842|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59843|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59844|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59845|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59846|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
60006|NCT02013245|O1|Outcome|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
59848|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59849|NCT02014467|E2|Reported Event|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
59850|NCT02014467|E1|Reported Event|Denosumab 60mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
59851|NCT02014441|B1|Baseline|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59852|NCT02014441|P1|Participant Flow|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59853|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59854|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59855|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59856|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59857|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59858|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59859|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59860|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59861|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59862|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59863|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59864|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59865|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59866|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59867|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59868|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59869|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59870|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59871|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59872|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59873|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
102359|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
59910|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
60136|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
59875|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59876|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59877|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59878|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59879|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59880|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59881|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59882|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59883|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59884|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59885|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59886|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59887|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59888|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59889|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59890|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59891|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59892|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59893|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59894|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59895|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59896|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59897|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59898|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59899|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59900|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59901|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59902|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59903|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59904|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59905|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59906|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59907|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59908|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59909|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
102542|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
59911|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59912|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59913|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59914|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59915|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59916|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59917|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59918|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59919|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59920|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59921|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59922|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59923|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59924|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59925|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59926|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59927|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59928|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59929|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59930|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59931|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59932|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59933|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59934|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59935|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59936|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59937|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59938|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59939|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
59940|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
59941|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59942|NCT02014441|E1|Reported Event|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
59943|NCT02014402|B5|Baseline|Total|Total of all reporting groups
60007|NCT02013245|E4|Reported Event|BCG Control Group|Intervention: Commercially available BCG live vaccine (standard dose 5 x 10^5 CFU)
60008|NCT02013245|E3|Reported Event|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
60134|NCT02013622|B1|Baseline|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
59944|NCT02014402|B4|Baseline|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59945|NCT02014402|B3|Baseline|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59946|NCT02014402|B2|Baseline|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59947|NCT02014402|B1|Baseline|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59948|NCT02014402|P4|Participant Flow|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59949|NCT02014402|P3|Participant Flow|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59950|NCT02014402|P2|Participant Flow|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59951|NCT02014402|P1|Participant Flow|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59952|NCT02014402|O5|Outcome|Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59953|NCT02014402|O4|Outcome|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59954|NCT02014402|O3|Outcome|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59955|NCT02014402|O2|Outcome|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59956|NCT02014402|O1|Outcome|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59957|NCT02014402|O5|Outcome|Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59958|NCT02014402|O4|Outcome|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59959|NCT02014402|O3|Outcome|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59960|NCT02014402|O2|Outcome|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59961|NCT02014402|O1|Outcome|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59962|NCT02014402|O5|Outcome|Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59963|NCT02014402|O4|Outcome|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59964|NCT02014402|O3|Outcome|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
60009|NCT02013245|E2|Reported Event|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
60010|NCT02013245|E1|Reported Event|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
59965|NCT02014402|O2|Outcome|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59966|NCT02014402|O1|Outcome|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
59967|NCT02014402|E10|Reported Event|Overall (IG1202-A, -B, -C, and -D): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
59968|NCT02014402|E9|Reported Event|Overall (IG1202-A, -B, -C, and -D): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
59969|NCT02014402|E8|Reported Event|IG1202-D (Spinal): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
59970|NCT02014402|E7|Reported Event|IG1202-D (Spinal): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
59971|NCT02014402|E6|Reported Event|IG1202-C (Soft Tissue): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
59972|NCT02014402|E5|Reported Event|IG1202-C (Soft Tissue): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
59973|NCT02014402|E4|Reported Event|IG1202-B (Hepatic): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
59974|NCT02014402|E3|Reported Event|IG1202-B (Hepatic): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
59975|NCT02014402|E2|Reported Event|IG1202-A (Vascular): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
59976|NCT02014402|E1|Reported Event|IG1202-A (Vascular): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
59977|NCT02014363|B4|Baseline|Total|Total of all reporting groups
59978|NCT02014363|B3|Baseline|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime
Amitriptyline"
59979|NCT02014363|B2|Baseline|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (high dose)"
59980|NCT02014363|B1|Baseline|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (low dose)"
59981|NCT02014363|P3|Participant Flow|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime
Amitriptyline"
59982|NCT02014363|P2|Participant Flow|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (high dose)"
59983|NCT02014363|P1|Participant Flow|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (low dose)"
59984|NCT02014363|O3|Outcome|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime
Amitriptyline"
59985|NCT02014363|O2|Outcome|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (high dose)"
59986|NCT02014363|O1|Outcome|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (low dose)"
59987|NCT02014363|E3|Reported Event|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime
Amitriptyline"
59988|NCT02014363|E2|Reported Event|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (high dose)"
59989|NCT02014363|E1|Reported Event|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (low dose)"
59990|NCT02013245|B5|Baseline|Total|Total of all reporting groups
59991|NCT02013245|B4|Baseline|BCG Control Group|BCG standard dose group (5 x 10^5 CFU BCG)
59992|NCT02013245|B3|Baseline|Group 3|MTBVAC high dose group (5 x 10^5 CFU MTBVAC)
59993|NCT02013245|B2|Baseline|Group 2|MTBVAC intermediate dose group (5 x 10^4 CFU MTBVAC)
59994|NCT02013245|B1|Baseline|Group 1|MTBVAC low dose group (5 x 10^3 CFU MTBVAC)
59995|NCT02013245|P4|Participant Flow|BCG Control Group|Intervention: Commercially available BCG live vaccine (dose 5 x 10^5 CFU)
59996|NCT02013245|P3|Participant Flow|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
59997|NCT02013245|P2|Participant Flow|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
59998|NCT02013245|P1|Participant Flow|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
59999|NCT02013245|O4|Outcome|BCG Control Group|Intervention: Commercially available BCg live vaccine (standard dose 5 x 10^5 CFU)
60000|NCT02013245|O3|Outcome|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
60001|NCT02013245|O2|Outcome|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
60002|NCT02013245|O1|Outcome|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
60003|NCT02013245|O4|Outcome|BCG Control Group|Intervention: Commercially available BCg live vaccine (standard dose 5 x 10^5 CFU)
60004|NCT02013245|O3|Outcome|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
60005|NCT02013245|O2|Outcome|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
60011|NCT02013206|B3|Baseline|Total|Total of all reporting groups
60012|NCT02013206|B2|Baseline|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
60013|NCT02013206|B1|Baseline|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
60014|NCT02013206|P2|Participant Flow|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
60015|NCT02013206|P1|Participant Flow|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
60016|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
60017|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
60018|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
60019|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
60020|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
60021|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
60022|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
60023|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
60024|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
60025|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
60026|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
60027|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
60028|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
60029|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
60030|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
60031|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
60032|NCT02013206|E2|Reported Event|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
60033|NCT02013206|E1|Reported Event|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
60034|NCT02014272|B1|Baseline|Entire Study Population|Includes all participants randomized to receive RIN 150 first and rifampicin and isoniazid first.
60035|NCT02014272|P2|Participant Flow|Rifampicin and Isoniazid First, Then RIN 150|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in first intervention period followed by single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.
60036|NCT02014272|P1|Participant Flow|RIN 150 First, Then Rifampicin and Isoniazid|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contained 150 milligram [mg] rifampicin and 75 mg isoniazid) on Day 1 in first intervention period, followed by single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.
60037|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
60038|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
60039|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
60040|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
60041|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
60042|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
60043|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
60044|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
60045|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
60046|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
60047|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
60048|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
60049|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
60050|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
60051|NCT02014272|E2|Reported Event|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
60052|NCT02014272|E1|Reported Event|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
60053|NCT02014051|B1|Baseline|All Participants|All participants who received at least 1 dose of SyB C-1101 either at 280 mg/dose or 560 mg/dose orally.
60054|NCT02014051|P2|Participant Flow|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60055|NCT02014051|P1|Participant Flow|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60056|NCT02014051|O1|Outcome|All Participants|All participants who received at least 1 dose of SyB C-1101 either at 280 mg/dose or 560 mg/dose orally.
60057|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60058|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60111|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60112|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60113|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60114|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60059|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60060|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60061|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60062|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60063|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60064|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60065|NCT02014051|E2|Reported Event|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60066|NCT02014051|E1|Reported Event|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.
The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.
The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
60067|NCT02013830|B1|Baseline|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
60068|NCT02013830|P1|Participant Flow|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 milligrams per kilogram (mg/kg) bevacizumab intravenously (IV) on Day 1; and 1600 mg per square meter per day (mg/m^2/day) capecitabine tablets, orally (PO), in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
60069|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
60070|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
60071|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
60072|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
60115|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60116|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60073|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
60074|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
60075|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
60076|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
60077|NCT02013830|E1|Reported Event|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
60078|NCT02013817|B1|Baseline|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
60079|NCT02013817|P1|Participant Flow|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
60080|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
60081|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
60082|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
60117|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60118|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60119|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60120|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60121|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60083|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
60084|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
60085|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
60086|NCT02013817|E1|Reported Event|Rituximab, Fludarabine, Cyclophosphamide|Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4. Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5. Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years).
60087|NCT02013765|B1|Baseline|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
60088|NCT02013765|P1|Participant Flow|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
60089|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
60090|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
60091|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
60092|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
60093|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
60094|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
60095|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
60096|NCT02013765|E1|Reported Event|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
60097|NCT02013687|B5|Baseline|Total|Total of all reporting groups
60098|NCT02013687|B4|Baseline|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60099|NCT02013687|B3|Baseline|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60100|NCT02013687|B2|Baseline|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60101|NCT02013687|B1|Baseline|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60102|NCT02013687|P4|Participant Flow|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60103|NCT02013687|P3|Participant Flow|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60104|NCT02013687|P2|Participant Flow|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60105|NCT02013687|P1|Participant Flow|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
60106|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60107|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60108|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60109|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60110|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
60138|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60139|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60140|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60141|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60142|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60143|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60144|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60145|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60146|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60147|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60148|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60149|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60150|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60151|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60152|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60153|NCT02013622|E1|Reported Event|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
60154|NCT02013609|B1|Baseline|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60155|NCT02013609|P1|Participant Flow|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 milligram per day (mg/day) for the first week with titration up to 3 mg/day once daily (QD) in addition to their constant-dose antidepressant therapy (ADT) for 12 weeks.
60156|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60157|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60158|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60159|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60160|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60161|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60162|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60163|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60164|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60165|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60166|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60167|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60168|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60169|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60170|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60171|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60261|NCT02013388|O4|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days"
60172|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60173|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60174|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60175|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60176|NCT02013609|E1|Reported Event|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
60177|NCT02013544|B3|Baseline|Total|Total of all reporting groups
60178|NCT02013544|B2|Baseline|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
60179|NCT02013544|B1|Baseline|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
60180|NCT02013544|P2|Participant Flow|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
60181|NCT02013544|P1|Participant Flow|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks
60182|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
60183|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
60184|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
60185|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
60186|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
60187|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
60188|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
60189|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
60190|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
60191|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
60192|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
60193|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
60194|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
60195|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
60196|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
60197|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
60198|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
60199|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
60200|NCT02013544|E2|Reported Event|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks
60201|NCT02013544|E1|Reported Event|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
60202|NCT02013531|B1|Baseline|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60203|NCT02013531|P1|Participant Flow|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 milligram per day (mg/day) with titration up to 3 mg/day once daily (QD) in addition to their constant-dose ADT (anti-depressant therapy) for 6 weeks.
60204|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60205|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60206|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60207|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60208|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60209|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60210|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60211|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60212|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60213|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60214|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60215|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
63667|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select OHN variables
60216|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60217|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60218|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60219|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60220|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60221|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60222|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
60223|NCT02013531|E1|Reported Event|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day to 3 mg/day, QD for 6 weeks.
60224|NCT02013388|B9|Baseline|Total|Total of all reporting groups
60225|NCT02013388|B8|Baseline|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
60226|NCT02013388|B7|Baseline|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1"
60227|NCT02013388|B6|Baseline|50 mg (Single Dose)|"single oral dose of 50 mg N91115
N91115: Given PO only on Day 1"
60228|NCT02013388|B5|Baseline|500 mg|"single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60229|NCT02013388|B4|Baseline|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days"
60230|NCT02013388|B3|Baseline|50 mg|"single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60231|NCT02013388|B2|Baseline|10 mg|"single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60232|NCT02013388|B1|Baseline|Placebo|"single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days"
60233|NCT02013388|P8|Participant Flow|Placebo-single Dose|Placebo: Given PO daily for 1 day
60234|NCT02013388|P7|Participant Flow|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1"
60235|NCT02013388|P6|Participant Flow|50 mg (Single Dose)|"single oral dose of 50 mg N91115
N91115: Given PO only on Day 1"
60236|NCT02013388|P5|Participant Flow|500 mg|"single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60237|NCT02013388|P4|Participant Flow|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days"
60238|NCT02013388|P3|Participant Flow|50 mg|"single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60239|NCT02013388|P2|Participant Flow|10 mg|"single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60240|NCT02013388|P1|Participant Flow|Placebo|"single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days"
60241|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60242|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days"
60243|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60244|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60245|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60246|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days"
60247|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60248|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60249|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60250|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days"
60251|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60252|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60253|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60254|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days"
60255|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60256|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60257|NCT02013388|O8|Outcome|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
60258|NCT02013388|O7|Outcome|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1"
60259|NCT02013388|O6|Outcome|50 mg (Single Dose)|"single oral dose of 50 mg N91115
N91115: Given PO only on Day 1"
60260|NCT02013388|O5|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60262|NCT02013388|O3|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60263|NCT02013388|O2|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60264|NCT02013388|O1|Outcome|Placebo|"single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days"
60265|NCT02013388|E8|Reported Event|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
63668|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select OHN variables
60266|NCT02013388|E7|Reported Event|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1"
60267|NCT02013388|E6|Reported Event|50 mg (Single Dose)|"single oral dose of 50 mg N91115
N91115: Given PO only on Day 1"
60268|NCT02013388|E5|Reported Event|500 mg|"single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60269|NCT02013388|E4|Reported Event|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days"
60270|NCT02013388|E3|Reported Event|50 mg|"single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60271|NCT02013388|E2|Reported Event|10 mg|"single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days"
60272|NCT02013388|E1|Reported Event|Placebo|"single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days"
60273|NCT02013167|B3|Baseline|Total|Total of all reporting groups
60274|NCT02013167|B2|Baseline|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60275|NCT02013167|B1|Baseline|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60276|NCT02013167|P2|Participant Flow|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60277|NCT02013167|P1|Participant Flow|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60278|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60279|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60280|NCT02013167|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60371|NCT02012582|B1|Baseline|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203"
60372|NCT02012582|P4|Participant Flow|Placebo|"0.9 % Sodium chloride infusion
Placebo"
60373|NCT02012582|P3|Participant Flow|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203"
60374|NCT02012582|P2|Participant Flow|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203"
60378|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203"
60379|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203"
60380|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion
Placebo"
60381|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203"
60281|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60282|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60283|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60284|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60285|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60286|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60287|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60288|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60289|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60290|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60375|NCT02012582|P1|Participant Flow|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203"
103539|NCT01766102|B3|Baseline|Total|Total of all reporting groups
60291|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60292|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60293|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60294|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60295|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60296|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60297|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60298|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60299|NCT02013167|O2|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60300|NCT02013167|O1|Outcome|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60376|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion
Placebo"
60377|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203"
60301|NCT02013167|E2|Reported Event|Blinatumomab|"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles."
60302|NCT02013167|E1|Reported Event|Standard of Care Chemotherapy|"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months."
60303|NCT02013050|B5|Baseline|Total|Total of all reporting groups
60304|NCT02013050|B4|Baseline|6.0 mg/kg|
60305|NCT02013050|B3|Baseline|3.0 mg/kg|
60306|NCT02013050|B2|Baseline|1.5 mg/kg|
60307|NCT02013050|B1|Baseline|Placebo|
60308|NCT02013050|P4|Participant Flow|6.0 mg/kg|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
60309|NCT02013050|P3|Participant Flow|3.0 mg/kg|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
60310|NCT02013050|P2|Participant Flow|1.5 mg/kg|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
60311|NCT02013050|P1|Participant Flow|Placebo|Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses
60312|NCT02013050|O4|Outcome|6.0 mg/kg|
60313|NCT02013050|O3|Outcome|3.0 mg/kg|
60314|NCT02013050|O2|Outcome|1.5 mg/kg|
60315|NCT02013050|O1|Outcome|Placebo|
60316|NCT02013050|O4|Outcome|6.0 mg/kg|
60317|NCT02013050|O3|Outcome|3.0 mg/kg|
60318|NCT02013050|O2|Outcome|1.5 mg/kg|
60319|NCT02013050|O1|Outcome|Placebo|
60320|NCT02013050|O4|Outcome|6.0 mg/kg|
60321|NCT02013050|O3|Outcome|3.0 mg/kg|
60322|NCT02013050|O2|Outcome|1.5 mg/kg|
60323|NCT02013050|O1|Outcome|Placebo|
60324|NCT02013050|O4|Outcome|6.0 mg/kg|
60325|NCT02013050|O3|Outcome|3.0 mg/kg|
60326|NCT02013050|O2|Outcome|1.5 mg/kg|
60327|NCT02013050|O1|Outcome|Placebo|
60328|NCT02013050|O4|Outcome|6.0 mg/kg|
60329|NCT02013050|O3|Outcome|3.0 mg/kg|
60330|NCT02013050|O2|Outcome|1.5 mg/kg|
60331|NCT02013050|O1|Outcome|Placebo|
60332|NCT02013050|O4|Outcome|6.0 mg/kg|
60333|NCT02013050|O3|Outcome|3.0 mg/kg|
60334|NCT02013050|O2|Outcome|1.5 mg/kg|
60335|NCT02013050|O1|Outcome|Placebo|
60336|NCT02013050|O4|Outcome|6.0 mg/kg|
60337|NCT02013050|O3|Outcome|3.0 mg/kg|
60338|NCT02013050|O2|Outcome|1.5 mg/kg|
60339|NCT02013050|O1|Outcome|Placebo|
60340|NCT02013050|O4|Outcome|6.0 mg/kg|
60341|NCT02013050|O3|Outcome|3.0 mg/kg|
60342|NCT02013050|O2|Outcome|1.5 mg/kg|
60343|NCT02013050|O1|Outcome|Placebo|
60344|NCT02013050|O4|Outcome|6.0 mg/kg|
60345|NCT02013050|O3|Outcome|3.0 mg/kg|
60346|NCT02013050|O2|Outcome|1.5 mg/kg|
60347|NCT02013050|O1|Outcome|Placebo|
60348|NCT02013050|E4|Reported Event|6.0 mg/kg|
60349|NCT02013050|E3|Reported Event|3.0 mg/kg|
60350|NCT02013050|E2|Reported Event|1.5 mg/kg|
60351|NCT02013050|E1|Reported Event|Placebo|
60352|NCT02012686|B3|Baseline|Total|Total of all reporting groups
60353|NCT02012686|B2|Baseline|TENS Group|numerical rating scale of TENS applied group
60354|NCT02012686|B1|Baseline|Control Group|numerical rating scale of TENS non-applied group
60355|NCT02012686|P2|Participant Flow|TENS Group|"numerical rating scale of TENS applied group
TENS: transcutaneous electric nerve stimulation"
60356|NCT02012686|P1|Participant Flow|Control Group|numerical rating scale of TENS non-applied group
60357|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group
TENS: transcutaneous electric nerve stimulation"
60358|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
60359|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group
TENS: transcutaneous electric nerve stimulation"
60360|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
60361|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group
TENS: transcutaneous electric nerve stimulation"
60362|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
60363|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group
TENS: transcutaneous electric nerve stimulation"
60364|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
60365|NCT02012686|E2|Reported Event|TENS Group|"numerical rating scale of TENS applied group
TENS: transcutaneous electric nerve stimulation"
60366|NCT02012686|E1|Reported Event|Control Group|numerical rating scale of TENS non-applied group
60367|NCT02012582|B5|Baseline|Total|Total of all reporting groups
60368|NCT02012582|B4|Baseline|Placebo|"0.9 % Sodium chloride infusion
Saline"
60369|NCT02012582|B3|Baseline|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203"
60370|NCT02012582|B2|Baseline|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203"
60382|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203"
60383|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203"
60384|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion
Placebo"
60385|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203"
60386|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203"
60387|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203"
60388|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion
Placebo"
60389|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203"
60390|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203"
60391|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203"
60392|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion
Placebo"
60393|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203"
60394|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203"
60395|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203"
60396|NCT02012582|E4|Reported Event|Placebo|"0.9 % Sodium chloride infusion
Placebo"
60397|NCT02012582|E3|Reported Event|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203"
60398|NCT02012582|E2|Reported Event|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203"
60399|NCT02012582|E1|Reported Event|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203"
60400|NCT02012452|B3|Baseline|Total|Total of all reporting groups
60401|NCT02012452|B2|Baseline|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
60402|NCT02012452|B1|Baseline|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
60403|NCT02012452|P2|Participant Flow|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
60404|NCT02012452|P1|Participant Flow|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
60405|NCT02012452|O2|Outcome|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
60406|NCT02012452|O1|Outcome|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
60407|NCT02012452|O2|Outcome|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
60408|NCT02012452|O1|Outcome|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
60409|NCT02012452|E2|Reported Event|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
60410|NCT02012452|E1|Reported Event|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
60411|NCT02012218|B6|Baseline|Total|Total of all reporting groups
60412|NCT02012218|B5|Baseline|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60413|NCT02012218|B4|Baseline|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60439|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system
Burst Stimulation: Prodigy Neurostimulation System with associated components"
60440|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system
Tonic Stimulation: Prodigy Neurostimulation System with associated components"
60414|NCT02012218|B3|Baseline|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
61022|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
60415|NCT02012218|B2|Baseline|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60416|NCT02012218|B1|Baseline|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60417|NCT02012218|P5|Participant Flow|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60418|NCT02012218|P4|Participant Flow|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60419|NCT02012218|P3|Participant Flow|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60420|NCT02012218|P2|Participant Flow|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60421|NCT02012218|P1|Participant Flow|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60422|NCT02012218|O5|Outcome|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60423|NCT02012218|O4|Outcome|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60424|NCT02012218|O3|Outcome|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60425|NCT02012218|O2|Outcome|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60426|NCT02012218|O1|Outcome|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60427|NCT02012218|E5|Reported Event|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60428|NCT02012218|E4|Reported Event|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60429|NCT02012218|E3|Reported Event|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60430|NCT02012218|E2|Reported Event|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60431|NCT02012218|E1|Reported Event|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
60432|NCT02011893|B1|Baseline|All Subjects|All subjects who were enrolled in the SUNBURST clinical study
60433|NCT02011893|P3|Participant Flow|Arm 2|Burst stimulation first, then Tonic
60434|NCT02011893|P2|Participant Flow|Arm 1|Tonic stimulation first, then Burst
60435|NCT02011893|P1|Participant Flow|Enrolled|All subjects enrolled through device activation/randomization
60436|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system
Tonic Stimulation: Prodigy Neurostimulation System with associated components"
60437|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system
Burst Stimulation: Prodigy Neurostimulation System with associated components"
60438|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system
Tonic Stimulation: Prodigy Neurostimulation System with associated components"
61014|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
60441|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system
Burst Stimulation: Prodigy Neurostimulation System with associated components"
60442|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system
Tonic Stimulation: Prodigy Neurostimulation System with associated components"
63669|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select OHN variables
60443|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system
Burst Stimulation: Prodigy Neurostimulation System with associated components"
60444|NCT02011893|E1|Reported Event|All Subjects|All subjects who were enrolled in the SUNBURST clinical study
60445|NCT02011516|B3|Baseline|Total|Total of all reporting groups
60446|NCT02011516|B2|Baseline|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician
Baclofen
Psychosocial"
60447|NCT02011516|B1|Baseline|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician
Psychosocial
Placebo"
60448|NCT02011516|P2|Participant Flow|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician
Baclofen
Psychosocial"
60449|NCT02011516|P1|Participant Flow|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician
Psychosocial
Placebo"
60450|NCT02011516|O2|Outcome|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician
Baclofen
Psychosocial"
60451|NCT02011516|O1|Outcome|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician
Psychosocial
Placebo"
60452|NCT02011516|E2|Reported Event|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician
Baclofen
Psychosocial"
60453|NCT02011516|E1|Reported Event|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician
Psychosocial
Placebo"
60454|NCT02011490|B4|Baseline|Total|Total of all reporting groups
60455|NCT02011490|B3|Baseline|Healthy Control Participants: Part 1 + Part 2|This group includes healthy control participants who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
60456|NCT02011490|B2|Baseline|Moderate Renal Insufficiency Participants: Part 1 + Part 2|This group includes participants with moderate renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
60457|NCT02011490|B1|Baseline|Severe Renal Insufficiency Participants: Part 1 + Part 2|This group includes participants with severe renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
60458|NCT02011490|P6|Participant Flow|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60459|NCT02011490|P5|Participant Flow|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60460|NCT02011490|P4|Participant Flow|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60461|NCT02011490|P3|Participant Flow|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60462|NCT02011490|P2|Participant Flow|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60463|NCT02011490|P1|Participant Flow|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an intravenous (IV) bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60464|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60465|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60485|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
61015|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
60486|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
63670|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select OHN variables
60466|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60467|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60468|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60469|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60470|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60471|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60472|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60473|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60474|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60475|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60476|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60477|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60478|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60479|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60480|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60481|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60482|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60483|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60484|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60487|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60488|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60489|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60490|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60491|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60492|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60493|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60494|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60495|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60496|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60497|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60498|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60499|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60500|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60501|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60502|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60503|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60504|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
61016|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
60505|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60506|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60507|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60508|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60509|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60510|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60511|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60512|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60513|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60514|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60515|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60516|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60517|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60518|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60519|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60520|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60521|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60522|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60523|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
61017|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
60578|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
60524|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60525|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60526|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60527|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60528|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60529|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60530|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60531|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60532|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60533|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60534|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60535|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60536|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60537|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60538|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60539|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60540|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60541|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60542|NCT02011490|E6|Reported Event|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60543|NCT02011490|E5|Reported Event|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60544|NCT02011490|E4|Reported Event|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
60545|NCT02011490|E3|Reported Event|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60546|NCT02011490|E2|Reported Event|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60547|NCT02011490|E1|Reported Event|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
60548|NCT02011464|B3|Baseline|Total|Total of all reporting groups
60549|NCT02011464|B2|Baseline|Control|Saline infiltrated into posterior compartment
60550|NCT02011464|B1|Baseline|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
60551|NCT02011464|P2|Participant Flow|Control|Saline infiltrated into posterior compartment of the knee
60552|NCT02011464|P1|Participant Flow|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
60553|NCT02011464|O2|Outcome|Control|Saline infiltrated into posterior compartment
60554|NCT02011464|O1|Outcome|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
60555|NCT02011464|O2|Outcome|Control|Saline infiltrated into posterior compartment
60556|NCT02011464|O1|Outcome|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
60557|NCT02011464|O12|Outcome|Control Group/Average Pain Scores at 72 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
60558|NCT02011464|O11|Outcome|Exparel Group/Average Pain Scores at 72 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
60559|NCT02011464|O10|Outcome|Control Group/Average Pain Scores at 48 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
60560|NCT02011464|O9|Outcome|Exparel Group/Average Pain Scores at 48 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
60561|NCT02011464|O8|Outcome|Control Group/Average Pain Scores at 24 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
60562|NCT02011464|O7|Outcome|Exparel Group/Average Pain Scores at 24 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
60563|NCT02011464|O6|Outcome|Control Group/Average Pain Scores at 12 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
60564|NCT02011464|O5|Outcome|Exparel Group/Average Pain Scores at 12 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
60565|NCT02011464|O4|Outcome|Control Group/Average Pain Scores at 8 Hours|Pain scores using the Number Rating Scale (NRS) from 0 - 10
60566|NCT02011464|O3|Outcome|Exparel Group/Average Pain Scores at 8 Hours|Pain scores using the Number Rating Scale (NRS) from 0 - 10
60567|NCT02011464|O2|Outcome|Control Group/Average Pain Scores at 4 Hours|Pain scores using the Numeric Rating Scale (NRS) 0 - 10
60568|NCT02011464|O1|Outcome|Exparel Group/Average Pain Scores at 4 Hours|Pain scores using the Number Rating Scale (NRS) from 0 - 10
60569|NCT02011464|E2|Reported Event|Control|Saline infiltrated into posterior compartment
60570|NCT02011464|E1|Reported Event|Exparel Inflitration|Exparel infiltrated into the posterior compartment of the knee
60571|NCT02011113|B1|Baseline|Pomalidomide Plus Dexamethasone|Pomalidomide: 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle Dexamethasone: 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle
60572|NCT02011113|P1|Participant Flow|Pomalidomide Plus Dexamethasone|Pomalidomide 4 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Dexamethasone 40 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are ≤ 75 years of age Dexamethasone 20 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are > 75 years of age
60573|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
60574|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
60575|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
60576|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
60577|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
60579|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
60580|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
60581|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
60582|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
60583|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
60584|NCT02011113|E1|Reported Event|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
60585|NCT02010996|B3|Baseline|Total|Total of all reporting groups
60586|NCT02010996|B2|Baseline|Axillary Dissection|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
60587|NCT02010996|B1|Baseline|Vacuum Assisted Closure|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
60588|NCT02010996|P2|Participant Flow|Axillary Dissection|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
60589|NCT02010996|P1|Participant Flow|Vacuum Assisted Closure|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
60590|NCT02010996|O4|Outcome|Axillary Dissection(Shank)|
60591|NCT02010996|O3|Outcome|Vacuum Assisted Closure(Shank)|
60592|NCT02010996|O2|Outcome|Axillary Dissection(Thigh)|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
60593|NCT02010996|O1|Outcome|Vacuum Assisted Closure(Thigh)|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
60594|NCT02010996|E4|Reported Event|Axillary Dissection(Shank)|
60595|NCT02010996|E3|Reported Event|Vacuum Assisted Closure(Shank)|
60596|NCT02010996|E2|Reported Event|Axillary Dissection(Thigh)|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
60597|NCT02010996|E1|Reported Event|Vacuum Assisted Closure(Thigh)|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
60598|NCT02010684|B3|Baseline|Total|Total of all reporting groups
60644|NCT02010255|P11|Participant Flow|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60599|NCT02010684|B2|Baseline|Empowerment and CBT Classes|"Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants will learn a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
60600|NCT02010684|B1|Baseline|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
60601|NCT02010684|P2|Participant Flow|Empowerment and CBT Classes|"Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. Then participants will learn a diabetes education format grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. Group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis.
Empowerment and CBT Classes: Participants will receive a manual with 3 CBT modules and 1 Diabetes Empowerment module. CBT Module 1 covers Understanding Depression and Diabetes, Module 2 How Thoughts Affect Your Mood and Diabetes Care, Module 3 How Activities Affect Your Mood and Diabetes Care. The Diabetes Empowerment Modu"
60602|NCT02010684|P1|Participant Flow|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
60603|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
60604|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
60605|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
60606|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
60607|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
60608|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
60642|NCT02010255|P13|Participant Flow|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
106292|NCT01755143|B3|Baseline|Total|Total of all reporting groups
60609|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
60610|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
60611|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
60612|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
60613|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
60614|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
60615|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
60616|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
60617|NCT02010684|E2|Reported Event|Empowerment and CBT Classes|"Weekly 2-hour group Empowerment and CBT classes for 12 weeks are led by two trained health educators. Cognitive behavioral therapy (CBT) techniques to manage mood and diabetes education, grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood, is presented. Group members monitor their blood sugar levels, blood pressure, and mood on a daily basis. The intervention arm participants receive a manual with 3 CBT modules (Understanding Depression and Diabetes, How Thoughts Affect Your Mood and Diabetes Care, andHow Activities Affect Your Mood and Diabetes Care. and 1 Diabetes Empowerment module. covers topics including the following: food, exercise, medicine, diabetes and your health, social support, communication skills, and community resources."
60618|NCT02010684|E1|Reported Event|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
60643|NCT02010255|P12|Participant Flow|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60619|NCT02010632|B1|Baseline|All Study Participants|First intervention: Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 Wash out period: 14 days Second intervention: Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
60620|NCT02010632|P2|Participant Flow|Original Clopidogrel Product|"Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
60621|NCT02010632|P1|Participant Flow|Generic Clopidogrel Product|"Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
60622|NCT02010632|O2|Outcome|Original Clopidogrel Product|"Plavix® 75mg tablet
Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
60623|NCT02010632|O1|Outcome|Generic Clopidogrel Product|"Apolets® 75 mg tablet
Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
60624|NCT02010632|E2|Reported Event|Original Clopidogrel Product|"Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
60625|NCT02010632|E1|Reported Event|Generic Clopidogrel Product|"Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
60626|NCT02010255|B15|Baseline|Total|Total of all reporting groups
60627|NCT02010255|B14|Baseline|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60628|NCT02010255|B13|Baseline|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60629|NCT02010255|B12|Baseline|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60630|NCT02010255|B11|Baseline|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60631|NCT02010255|B10|Baseline|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60632|NCT02010255|B9|Baseline|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60633|NCT02010255|B8|Baseline|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60634|NCT02010255|B7|Baseline|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60635|NCT02010255|B6|Baseline|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60636|NCT02010255|B5|Baseline|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60637|NCT02010255|B4|Baseline|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60638|NCT02010255|B3|Baseline|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60639|NCT02010255|B2|Baseline|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60640|NCT02010255|B1|Baseline|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60641|NCT02010255|P14|Participant Flow|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60645|NCT02010255|P10|Participant Flow|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60646|NCT02010255|P9|Participant Flow|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60647|NCT02010255|P8|Participant Flow|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60648|NCT02010255|P7|Participant Flow|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60649|NCT02010255|P6|Participant Flow|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60650|NCT02010255|P5|Participant Flow|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis."
60651|NCT02010255|P4|Participant Flow|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60652|NCT02010255|P3|Participant Flow|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60653|NCT02010255|P2|Participant Flow|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60654|NCT02010255|P1|Participant Flow|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
60655|NCT02010255|O10|Outcome|Cohort B: Baseline CPT Class C (24 wk)|Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
60656|NCT02010255|O9|Outcome|Cohort B: Baseline CPT Class C (12 wk)|Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
60657|NCT02010255|O8|Outcome|Cohort B: Baseline CPT Class B (24 wk)|Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
60658|NCT02010255|O7|Outcome|Cohort B: Baseline CPT Class B (12 wk)|Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
60659|NCT02010255|O6|Outcome|Cohort B: Baseline CPT Class A (24 wk)|Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
60660|NCT02010255|O5|Outcome|Cohort B: Baseline CPT Class A (12 wk)|Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
60661|NCT02010255|O4|Outcome|Cohort A: Baseline CPT Class C (24 wk)|Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
60662|NCT02010255|O3|Outcome|Cohort A: Baseline CPT Class C (12 wk)|Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
60663|NCT02010255|O2|Outcome|Cohort A: Baseline CPT Class B (24 wk)|Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
60664|NCT02010255|O1|Outcome|Cohort A: Baseline CPT Class B (12 wk)|Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
60665|NCT02010255|O10|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60666|NCT02010255|O9|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60667|NCT02010255|O8|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60668|NCT02010255|O7|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60669|NCT02010255|O6|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60670|NCT02010255|O5|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60671|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60672|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60673|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60674|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
60675|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60676|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60677|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60678|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60679|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60680|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60681|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60682|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60683|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60684|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60685|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60686|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60687|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60688|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60689|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
107340|NCT01749982|O1|Outcome|Placebo|"Placebo tablets
Placebo"
60690|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
89799|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
60691|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60692|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60693|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60694|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60695|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60696|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60697|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60698|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60699|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60700|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60701|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60702|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60703|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60704|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60705|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60706|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60707|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60708|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60709|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60710|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60711|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60712|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60713|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60737|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60714|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60715|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60716|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60717|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60718|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60719|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60720|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60721|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60722|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60723|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60724|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60725|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60726|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60727|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60728|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60729|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60730|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60731|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60732|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60733|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60734|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60735|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60736|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
61018|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
61837|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
60738|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60739|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60740|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60741|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60742|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60743|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60744|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60745|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60746|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60747|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60748|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60749|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60750|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60751|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60752|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60753|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60754|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60755|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60756|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60757|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60758|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60759|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60760|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60761|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60762|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60763|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60764|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60765|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60766|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60767|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60768|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60769|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60770|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60771|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60772|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60773|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60774|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60775|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60776|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60777|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60778|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60779|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60780|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60781|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60782|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60783|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60784|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60785|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60786|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60787|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60788|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60789|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60790|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60791|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60792|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60793|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60794|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60795|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60796|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60797|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60798|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60799|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60800|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60801|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60802|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60803|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60804|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60805|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60806|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60807|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60808|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60809|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
61023|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
60810|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60811|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60812|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60813|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60814|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60815|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60816|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60817|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60818|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60819|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60820|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60821|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60822|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60823|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60824|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60825|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60826|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60827|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60828|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60829|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60830|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60831|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60832|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60856|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60833|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60834|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60835|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60836|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60837|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60838|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60839|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60840|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60841|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60842|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60843|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60844|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60845|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60846|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60847|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60848|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60849|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60850|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60851|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60852|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60853|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60854|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60855|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
61019|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
61838|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
60857|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60858|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60859|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60860|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60861|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60862|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60863|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60864|NCT02010255|O1|Outcome|All LDV/SOF+RBV|All participants in the analysis are presented in a single group, regardless of randomization group assignment.
60865|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60866|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60867|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60868|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60869|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60870|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60871|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60872|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60873|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60874|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60875|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60876|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60877|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60878|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60879|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60880|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60928|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60881|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60882|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60883|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60884|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60885|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60886|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60887|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60888|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60889|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60890|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60891|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60892|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60893|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60894|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60895|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60896|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60897|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60898|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60899|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60900|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60901|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60902|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60903|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60927|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60904|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60905|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60906|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60907|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60908|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60909|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60910|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60911|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60912|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60913|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60914|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60915|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60916|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60917|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60918|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60919|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60920|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60921|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60922|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60923|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60924|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60925|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60926|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
61013|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
61839|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
60929|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60930|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60931|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60932|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60933|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60934|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60935|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60936|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60937|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60938|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60939|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60940|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60941|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60942|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60943|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60944|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60945|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60946|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60947|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60948|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60949|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60950|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60951|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
61840|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
61020|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
61021|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
60952|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60953|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60954|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60955|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60956|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60957|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60958|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
60959|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60960|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60961|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60962|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60963|NCT02010255|E14|Reported Event|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
60964|NCT02010255|E13|Reported Event|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
60965|NCT02010255|E12|Reported Event|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60966|NCT02010255|E11|Reported Event|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
60967|NCT02010255|E10|Reported Event|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60968|NCT02010255|E9|Reported Event|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
60969|NCT02010255|E8|Reported Event|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
60970|NCT02010255|E7|Reported Event|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
60971|NCT02010255|E6|Reported Event|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
60972|NCT02010255|E5|Reported Event|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis."
60973|NCT02010255|E4|Reported Event|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
60974|NCT02010255|E3|Reported Event|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
61841|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
60975|NCT02010255|E2|Reported Event|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
60976|NCT02010255|E1|Reported Event|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
60977|NCT02010216|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
60978|NCT02010216|P1|Participant Flow|Tocilizumab [RoActemra/Actemra]|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
60979|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
60980|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
60981|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
60982|NCT02010216|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
60983|NCT02009982|B3|Baseline|Total|Total of all reporting groups
60984|NCT02009982|B2|Baseline|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
60985|NCT02009982|B1|Baseline|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter
Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium
Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
60986|NCT02009982|P2|Participant Flow|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
60987|NCT02009982|P1|Participant Flow|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter
Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium
Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
60988|NCT02009982|O2|Outcome|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
60989|NCT02009982|O1|Outcome|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter
Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium
Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
60990|NCT02009982|O2|Outcome|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
60991|NCT02009982|O1|Outcome|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter
Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium
Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
60992|NCT02009982|E2|Reported Event|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
60993|NCT02009982|E1|Reported Event|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter
Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium
Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
60994|NCT02009878|B4|Baseline|Total|Total of all reporting groups
60995|NCT02009878|B3|Baseline|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
60996|NCT02009878|B2|Baseline|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
60997|NCT02009878|B1|Baseline|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
60998|NCT02009878|P3|Participant Flow|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
60999|NCT02009878|P2|Participant Flow|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
61000|NCT02009878|P1|Participant Flow|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
61001|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
61002|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
61003|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
61004|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
61005|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
61006|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
61007|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
61008|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
61009|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
61010|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
61011|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
61012|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
61024|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
61025|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
61026|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
61027|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
61028|NCT02009878|E3|Reported Event|Tolvaptan 15 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
61029|NCT02009878|E2|Reported Event|Tolvaptan 7.5 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
61030|NCT02009878|E1|Reported Event|Tolvaptan 3.75 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
61031|NCT02009865|B3|Baseline|Total|Total of all reporting groups
61032|NCT02009865|B2|Baseline|Olive Oil|2g once daily (QD)
61033|NCT02009865|B1|Baseline|Epanova|2g once daily (QD)
61034|NCT02009865|P2|Participant Flow|Olive Oil|2g once daily (QD)
61035|NCT02009865|P1|Participant Flow|Epanova|2g once daily (QD)
61036|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
61037|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
61038|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
61039|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
61040|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
61041|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
61042|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
61043|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
61044|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
61045|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
61046|NCT02009865|E2|Reported Event|Olive Oil|2g once daily (QD)
61047|NCT02009865|E1|Reported Event|Epanova|2g once daily (QD)
61048|NCT02009722|B3|Baseline|Total|Total of all reporting groups
61049|NCT02009722|B2|Baseline|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61050|NCT02009722|B1|Baseline|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61051|NCT02009722|P2|Participant Flow|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61052|NCT02009722|P1|Participant Flow|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61053|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61054|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61055|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61056|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61092|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61057|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61058|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61059|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61060|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61061|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61062|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61063|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61064|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61065|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61066|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61067|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61068|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61069|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61070|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61983|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
61071|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61072|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61073|NCT02009722|E2|Reported Event|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
61074|NCT02009722|E1|Reported Event|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
61075|NCT02009696|B1|Baseline|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
61076|NCT02009696|P1|Participant Flow|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
61077|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
61078|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
61079|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
61080|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
61081|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
61082|NCT02009696|E1|Reported Event|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
61083|NCT02009163|B1|Baseline|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
61084|NCT02009163|P3|Participant Flow|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26­week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61085|NCT02009163|P2|Participant Flow|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61086|NCT02009163|P1|Participant Flow|SPD489 (Open-label Period)|SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4-week open-label dose-optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been down-titrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose-optimization was maintained throughout the 8-week dose-maintenance period. The total time of the open-label period was 12 weeks.
61087|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61088|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61089|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61090|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61091|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label phase and who had a post-baseline safety assessment.
61984|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
61093|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61094|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
61095|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61096|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61097|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
61098|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61099|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61100|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
61101|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61102|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61103|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
61104|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61105|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61106|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
61107|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61108|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61109|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61110|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61111|NCT02009163|O2|Outcome|SPD489 (Randomized­-Withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70 mg was continued throughout the 26-week double-blind randomized-­withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61112|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61113|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61114|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61115|NCT02009163|E3|Reported Event|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
61116|NCT02009163|E2|Reported Event|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week .
61322|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61147|NCT02008617|P2|Participant Flow|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
61395|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
61117|NCT02009163|E1|Reported Event|SPD489 (Open-label Period)|SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4-week open-label dose-optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been down-titrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose-optimization was maintained throughout the 8-week dose-maintenance period. The total time of the open-label period was 12 weeks.
61118|NCT02008942|B1|Baseline|All Study Participants|All patients that received at least 1 dose of study drug
61119|NCT02008942|P2|Participant Flow|Enteric Coated (EC) Aspirin First, Then PL2200 Aspirin|"First Intervention Period:
EC aspirin: 325 mg aspirin; once per day for 10 days
(after 2-week washout period)
Second Intervention Period:
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
61120|NCT02008942|P1|Participant Flow|PL2200 Aspirin First, Then Enteric Coated (EC) Aspirin|"First Intervention Period:
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days
(after 2-week washout period)
Second Intervention Period:
EC aspirin: 325 mg aspirin; once per day for 10 days"
61121|NCT02008942|O2|Outcome|Enteric-coated Aspirin Caplets|"Enteric-coated aspirin caplets
Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days"
61122|NCT02008942|O1|Outcome|PL2200 Aspirin Capsules|"PL2200 Aspirin Capsules
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
61123|NCT02008942|E2|Reported Event|Enteric-coated Aspirin Caplets|"Enteric-coated aspirin caplets
Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days"
61124|NCT02008942|E1|Reported Event|PL2200 Aspirin Capsules|"PL2200 Aspirin Capsules
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
61125|NCT02008682|B3|Baseline|Total|Total of all reporting groups
61126|NCT02008682|B2|Baseline|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
61127|NCT02008682|B1|Baseline|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
61128|NCT02008682|P2|Participant Flow|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
61129|NCT02008682|P1|Participant Flow|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
61130|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
61131|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
61132|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
61133|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
61134|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
61135|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
61136|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
61137|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
61138|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
61139|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
61140|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
61141|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
61142|NCT02008682|E2|Reported Event|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
61143|NCT02008682|E1|Reported Event|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
61144|NCT02008617|B3|Baseline|Total|Total of all reporting groups
61145|NCT02008617|B2|Baseline|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
61146|NCT02008617|B1|Baseline|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
61148|NCT02008617|P1|Participant Flow|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
61149|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
61150|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
61151|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
61152|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
61153|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
61154|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
61155|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
61156|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
61157|NCT02008617|E2|Reported Event|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
61158|NCT02008617|E1|Reported Event|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
61159|NCT02008227|B3|Baseline|Total|Total of all reporting groups
61160|NCT02008227|B2|Baseline|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61161|NCT02008227|B1|Baseline|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61162|NCT02008227|P2|Participant Flow|Atezolizumab|Atezolizumab 1200 milligrams (mg) was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61163|NCT02008227|P1|Participant Flow|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61164|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61165|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61166|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61167|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61168|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61169|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61170|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61171|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61172|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61173|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
63671|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select OHN variables
61174|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61175|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61176|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61177|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61178|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61179|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61180|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61181|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61182|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61183|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61184|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61185|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61186|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61187|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61188|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61189|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61190|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61191|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61192|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61193|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61194|NCT02008227|O1|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61195|NCT02008227|O1|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61196|NCT02008227|O1|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61197|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61198|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61199|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61200|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61201|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61202|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61203|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61204|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61205|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61206|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61207|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61208|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61209|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61210|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61211|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61212|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61213|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61214|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61215|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61216|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61217|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61218|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61219|NCT02008227|O2|Outcome|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61220|NCT02008227|O1|Outcome|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61221|NCT02008227|E2|Reported Event|Atezolizumab|Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61222|NCT02008227|E1|Reported Event|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
61243|NCT02007577|P2|Participant Flow|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner
Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
63672|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select OHN variables
61223|NCT02007954|B1|Baseline|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61224|NCT02007954|P1|Participant Flow|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61225|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61226|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61227|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61228|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61229|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61230|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61241|NCT02007577|B2|Baseline|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner
Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
61242|NCT02007577|B1|Baseline|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner
salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
61985|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
61231|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61232|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61233|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61234|NCT02007954|O1|Outcome|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61235|NCT02007954|E1|Reported Event|DEBDOX|DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
61236|NCT02007863|B1|Baseline|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0
Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.
Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.
Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
61237|NCT02007863|P1|Participant Flow|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0
Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.
Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.
Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
61238|NCT02007863|O1|Outcome|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0
Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.
Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.
Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
61239|NCT02007863|E1|Reported Event|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0
Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.
Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.
Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
61240|NCT02007577|B3|Baseline|Total|Total of all reporting groups
61244|NCT02007577|P1|Participant Flow|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner
salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
61245|NCT02007577|O2|Outcome|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner
Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
61246|NCT02007577|O1|Outcome|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner
salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
61247|NCT02007577|O2|Outcome|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner
Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
61248|NCT02007577|O1|Outcome|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner
salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
61249|NCT02007577|E2|Reported Event|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner
Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
61250|NCT02007577|E1|Reported Event|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner
salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
61251|NCT02007434|B9|Baseline|Total|Total of all reporting groups
61252|NCT02007434|B8|Baseline|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61253|NCT02007434|B7|Baseline|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61254|NCT02007434|B6|Baseline|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61255|NCT02007434|B5|Baseline|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61256|NCT02007434|B4|Baseline|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61257|NCT02007434|B3|Baseline|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61258|NCT02007434|B2|Baseline|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61259|NCT02007434|B1|Baseline|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61260|NCT02007434|P8|Participant Flow|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61261|NCT02007434|P7|Participant Flow|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61262|NCT02007434|P6|Participant Flow|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61263|NCT02007434|P5|Participant Flow|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61264|NCT02007434|P4|Participant Flow|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61265|NCT02007434|P3|Participant Flow|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61266|NCT02007434|P2|Participant Flow|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61267|NCT02007434|P1|Participant Flow|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline Clinician-Reported Submental Fat Rating Scale [CR-SMFRS] grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area.
61268|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61269|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61296|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61270|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61271|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61272|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61273|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61274|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61275|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61276|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61277|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61278|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61279|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61280|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61281|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61282|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61283|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61284|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61285|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61286|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61287|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61288|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61289|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61290|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61291|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61292|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61293|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61294|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61295|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61986|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
61297|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61298|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61299|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61300|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61301|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61302|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61303|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61304|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61305|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61306|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61307|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61308|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61309|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61310|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61311|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61312|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61313|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61314|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61315|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61316|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61317|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61318|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61319|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61320|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61321|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61494|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
61323|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61324|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61325|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61326|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61327|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61328|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61329|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61330|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61331|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61332|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61333|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61334|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61335|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61336|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61337|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61338|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61339|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61340|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61341|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 to 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61342|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61343|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61344|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61345|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61346|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61347|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61348|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61495|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
61394|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
89800|NCT01843374|O2|Outcome|PLACEBO|Placebo.
61349|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61350|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61351|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61352|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61353|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61354|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61355|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61356|NCT02007434|E8|Reported Event|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61357|NCT02007434|E7|Reported Event|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61358|NCT02007434|E6|Reported Event|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
61359|NCT02007434|E5|Reported Event|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
61360|NCT02007434|E4|Reported Event|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
61361|NCT02007434|E3|Reported Event|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
61362|NCT02007434|E2|Reported Event|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61363|NCT02007434|E1|Reported Event|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
61364|NCT02007369|B4|Baseline|Total|Total of all reporting groups
61365|NCT02007369|B3|Baseline|Control|No intervention
61366|NCT02007369|B2|Baseline|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.
Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
61367|NCT02007369|B1|Baseline|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks
Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
61368|NCT02007369|P3|Participant Flow|Control|No intervention
61369|NCT02007369|P2|Participant Flow|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks
Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
61370|NCT02007369|P1|Participant Flow|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks
Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
61371|NCT02007369|O3|Outcome|Control|No intervention
61392|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
61393|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
61372|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.
Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
61373|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks
Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
61374|NCT02007369|O3|Outcome|Control|No intervention
61375|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.
Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
61376|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks
Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
61377|NCT02007369|O3|Outcome|Control|No intervention
61378|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.
Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
61379|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks
Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
61380|NCT02007369|O3|Outcome|Control|No intervention
61381|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.
Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
61382|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks
Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
61383|NCT02007369|E3|Reported Event|Control|No intervention
61384|NCT02007369|E2|Reported Event|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.
Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
61385|NCT02007369|E1|Reported Event|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks
Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
61386|NCT02007278|B3|Baseline|Total|Total of all reporting groups
61387|NCT02007278|B2|Baseline|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
61388|NCT02007278|B1|Baseline|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
61389|NCT02007278|P2|Participant Flow|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
61390|NCT02007278|P1|Participant Flow|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
61391|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
61396|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
61397|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
61398|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
61399|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
61400|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
61401|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
61402|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
61403|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
61404|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
61405|NCT02007278|O2|Outcome|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
61406|NCT02007278|O1|Outcome|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
61407|NCT02007278|E2|Reported Event|Glimepiride and Metformin|Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
61408|NCT02007278|E1|Reported Event|Vildagliptin and Metformin|Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
61409|NCT02007252|B3|Baseline|Total|Total of all reporting groups
61410|NCT02007252|B2|Baseline|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
61411|NCT02007252|B1|Baseline|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
61412|NCT02007252|P2|Participant Flow|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
61413|NCT02007252|P1|Participant Flow|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
61414|NCT02007252|O2|Outcome|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
61415|NCT02007252|O1|Outcome|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
61416|NCT02007252|E2|Reported Event|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
61417|NCT02007252|E1|Reported Event|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
61418|NCT02007200|B1|Baseline|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
61419|NCT02007200|P1|Participant Flow|Treatment (Soy Isoflavones)|"Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
55 patients were enrolled. 3 of these patients did not receive treatment."
61420|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
61421|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
61422|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
61423|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
61424|NCT02007200|E1|Reported Event|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
61425|NCT02007070|B1|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
61426|NCT02007070|P1|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
61427|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
61428|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
61429|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
61430|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
61431|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
61432|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
61433|NCT02007070|E1|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
61434|NCT02006836|B4|Baseline|Total|Total of all reporting groups
61490|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
61491|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
61435|NCT02006836|B3|Baseline|Diabetic 2|For self-control period. The scheme and dose of Continuous Subcutaneous Insulin Infusion (CSII) for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days.
61436|NCT02006836|B2|Baseline|Healthy|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
61437|NCT02006836|B1|Baseline|Diabetic|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
61438|NCT02006836|P3|Participant Flow|Self-Control: Diabetic 2|"For self-control period. Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days.
On the 4th to 6th day, patients with a constant dose of insulin did not consume Majia pomelos after meals, and this intervention was defined as blank.
On the 7th to 9th day, patients with the same dose of insulin consumed 100g Majia pomelos after meals (breakfast, lunch and dinner)."
61439|NCT02006836|P2|Participant Flow|Case-Control: Healthy|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
61440|NCT02006836|P1|Participant Flow|Case-Control: Diabetic|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
61441|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
61442|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
61443|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
61444|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
61445|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
61446|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
61447|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
61448|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
61449|NCT02006836|O2|Outcome|Healthy|For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
61450|NCT02006836|O1|Outcome|Diabetic|For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
61492|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61493|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61496|NCT02006732|E4|Reported Event|Tiotropium 5 μg +Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61497|NCT02006732|E3|Reported Event|Tiotropium 2.5 μg +Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
89801|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
61451|NCT02006836|E4|Reported Event|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
61452|NCT02006836|E3|Reported Event|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
61453|NCT02006836|E2|Reported Event|Healthy|On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of volunteers enrolled for the case control period.
61454|NCT02006836|E1|Reported Event|Diabetic|Diabetic patients use oral antidiabetic drugs(metformin or pioglitazone or both) or only life style modification. On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of diabetic patients enrolled for the case control period.
61455|NCT02006732|B5|Baseline|Total|Total of all reporting groups
61456|NCT02006732|B4|Baseline|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61457|NCT02006732|B3|Baseline|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61458|NCT02006732|B2|Baseline|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
61459|NCT02006732|B1|Baseline|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
61460|NCT02006732|P4|Participant Flow|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61461|NCT02006732|P3|Participant Flow|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61462|NCT02006732|P2|Participant Flow|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
61463|NCT02006732|P1|Participant Flow|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
61464|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61465|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61466|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
61467|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
61468|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61469|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61470|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
61471|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
61472|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61473|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61474|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
61475|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
61476|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61477|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61478|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
61479|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
61480|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61481|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61482|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
61483|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
61484|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61485|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61486|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
61487|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
61488|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61489|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
61987|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
61498|NCT02006732|E2|Reported Event|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
61499|NCT02006732|E1|Reported Event|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
61500|NCT02006719|B3|Baseline|Total|Total of all reporting groups
61501|NCT02006719|B2|Baseline|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61502|NCT02006719|B1|Baseline|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61503|NCT02006719|P2|Participant Flow|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61504|NCT02006719|P1|Participant Flow|AA4500|Up to 3 injections of 0.58 mg/1 mL collagenase clostridium histolyticum (AA4500), minimum of 21 days apart and home shoulder exercise
61505|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61506|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61507|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61508|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61509|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61510|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61511|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61512|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61513|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61514|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61515|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61516|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61517|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61518|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61519|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61520|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61521|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61522|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61523|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61524|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61525|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61526|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61527|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61528|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61529|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61530|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61531|NCT02006719|E2|Reported Event|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
61532|NCT02006719|E1|Reported Event|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
61533|NCT02006706|B1|Baseline|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
61534|NCT02006706|P1|Participant Flow|Rituximab/Methylprednisolone/Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg), intravaneously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
61535|NCT02006706|O1|Outcome|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
61536|NCT02006706|O1|Outcome|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
61647|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
61988|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
61575|NCT02006108|E1|Reported Event|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg
Interventions:
Drug: Feraheme Procedure: MR Scan
Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging
MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
61537|NCT02006706|E1|Reported Event|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
61538|NCT02006667|B1|Baseline|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
61539|NCT02006667|P1|Participant Flow|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg per kilogram (mg/kg), IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
61540|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
61541|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
61542|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
61543|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
61544|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
61545|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
61546|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
61547|NCT02006667|E1|Reported Event|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
61548|NCT02006407|B1|Baseline|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).
Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.
MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)
Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
61549|NCT02006407|P1|Participant Flow|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).
Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.
MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)
Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
61550|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).
Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.
MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)
Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
61551|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).
Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.
MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)
Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
61648|NCT02005484|E1|Reported Event|Trastuzumab Monotherapy|Participants received trastuzumab via IV infusion once weekly at an initial dose of 4 mg/kg at Visit 1, and 2 mg/kg at each subsequent visit for a maximum of 33 visits.
61552|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).
Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.
MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)
Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
61553|NCT02006407|E1|Reported Event|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).
Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.
MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)
Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
61554|NCT02006342|B3|Baseline|Total|Total of all reporting groups
61555|NCT02006342|B2|Baseline|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin"
61556|NCT02006342|B1|Baseline|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin"
61557|NCT02006342|P2|Participant Flow|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin"
61558|NCT02006342|P1|Participant Flow|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin"
61559|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin"
61560|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin"
61561|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin"
61562|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin"
61563|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin"
61564|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin"
61565|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin"
61566|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin"
61567|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin"
61568|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin"
61569|NCT02006342|E2|Reported Event|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin"
61570|NCT02006342|E1|Reported Event|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin"
61571|NCT02006108|B1|Baseline|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg
Interventions:
Drug: Feraheme Procedure: MR Scan
Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging
MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
61572|NCT02006108|P1|Participant Flow|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg
Interventions:
Drug: Feraheme Procedure: MR Scan
Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging
MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
61573|NCT02006108|O1|Outcome|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg
Interventions:
Drug: Feraheme Procedure: MR Scan
Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging
MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
61574|NCT02006108|O1|Outcome|Feraheme|"Intravenous injection of Feraheme, 5 mg Fe/kg
Interventions:
Drug: Feraheme Procedure: MR Scan
Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging
MRI-GE Healthcare 3 Tesla magnet: All patients will undergo"
61577|NCT02005692|P1|Participant Flow|DynaSense Sensor|"All patients enrolled in the study were prescribed a Q2 hour (every 2 hour) turning protocol, as per the standard guidelines of the study site. In the context of the study, caregivers were not asked to turn patients any more or less frequently than what the study site's standard turning protocol required.
The rate of compliance with prescribed turning protocols was measured using the DynaSense System."
61578|NCT02005692|O1|Outcome|DynaSense Sensor|All subjects who successfully completed the study.
61579|NCT02005692|O1|Outcome|DynaSense Sensor|All subjects enrolled in the study.
61580|NCT02005692|E1|Reported Event|DynaSense Sensor|All subjects enrolled in the study.
61581|NCT02005601|B3|Baseline|Total|Total of all reporting groups
61582|NCT02005601|B2|Baseline|Control|"Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61583|NCT02005601|B1|Baseline|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61584|NCT02005601|P2|Participant Flow|Control|"Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61585|NCT02005601|P1|Participant Flow|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61586|NCT02005601|O2|Outcome|Control|"Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61587|NCT02005601|O1|Outcome|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61588|NCT02005601|O2|Outcome|Control|"Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61589|NCT02005601|O1|Outcome|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61590|NCT02005601|O2|Outcome|Control|"Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61591|NCT02005601|O1|Outcome|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61592|NCT02005601|E2|Reported Event|Control|"Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61593|NCT02005601|E1|Reported Event|Duloxetine|"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."
61594|NCT02005562|B3|Baseline|Total|Total of all reporting groups
61595|NCT02005562|B2|Baseline|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61596|NCT02005562|B1|Baseline|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61597|NCT02005562|P2|Participant Flow|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61649|NCT02005393|B1|Baseline|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System immediately followed by Image Acquisition with NBI
FICE Image Acquisition System: Images Captured with FICE Device"
61723|NCT02005029|O1|Outcome|Erythromycin|Area under the curve 0-4 hours for plasma levodopa after erythromycin
61651|NCT02005393|O1|Outcome|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System, immediately followed by NBI Image Acquisition; always in that order.
FICE Image Acquisition System: Images Captured with FICE Device"
61727|NCT02005029|E1|Reported Event|Erythromycin|Participants who received a one time dose of IV erythromycin
63673|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select OHN variables
61598|NCT02005562|P1|Participant Flow|Mycophenolate Mofetil, Adapted Dose|Participants received mycophenolate mofetil (MMF), 3 grams (g), tablets or capsules, orally (PO), every 12 hours (q12h) adapted to mycophenolic acid (MPA) by area under the curve (AUC) on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a 2 hour postdose (C2) level equal to (=) 1000 to 1500 nanograms per milliliter (ng/mL) from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 milligrams (mg), intravenously (IV), on Day -1 or Day 0, and 0.5 mg per kilogram (mg/kg), PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-interleukin (IL)-2R, per the investigator's discretion.
61599|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61600|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61601|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61602|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61603|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61604|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61605|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61606|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61607|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61608|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61609|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61724|NCT02005029|O2|Outcome|Placebo|Mean gastric emptying time for participants receiving placebo
61610|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61611|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61612|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61613|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61614|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61615|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61616|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61617|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61618|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61619|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61620|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61621|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61650|NCT02005393|P1|Participant Flow|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition immediately followed by NBI Image Acquisition
FICE Image Acquisition System: Images Captured with FICE Device"
89802|NCT01843374|O2|Outcome|PLACEBO|Placebo.
61622|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61623|NCT02005562|E2|Reported Event|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61624|NCT02005562|E1|Reported Event|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
61625|NCT02005549|B1|Baseline|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
61626|NCT02005549|P1|Participant Flow|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 milligrams/kilogram (mg/kg) intravenously (IV), followed by docetaxel 75 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 950 mg/m^2 orally (PO) twice daily (BID) within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
61627|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
61628|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
61629|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
61630|NCT02005549|E1|Reported Event|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
61631|NCT02005536|B1|Baseline|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
61632|NCT02005536|P1|Participant Flow|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
61633|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
61634|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
61635|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
61636|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
61637|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
61638|NCT02005536|E1|Reported Event|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
61639|NCT02005484|B1|Baseline|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
61640|NCT02005484|P1|Participant Flow|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
61641|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
61642|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
61643|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
61644|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
61645|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
61646|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
61652|NCT02005393|E1|Reported Event|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System, immediately followed by Image Acquisition with NBI
FICE Image Acquisition System: Images Captured with FICE Device
No AE's"
61653|NCT02005211|B8|Baseline|Total|Total of all reporting groups
61654|NCT02005211|B7|Baseline|Placebo Part 2|Placebo Part 2 - MAD
61655|NCT02005211|B6|Baseline|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
61656|NCT02005211|B5|Baseline|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
61657|NCT02005211|B4|Baseline|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
61658|NCT02005211|B3|Baseline|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
61659|NCT02005211|B2|Baseline|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
61660|NCT02005211|B1|Baseline|Placebo Part 1|Placebo Part 1 - SAD
61661|NCT02005211|P7|Participant Flow|Placebo Part 2|Placebo Part 2 - MAD
61662|NCT02005211|P6|Participant Flow|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
61663|NCT02005211|P5|Participant Flow|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
61664|NCT02005211|P4|Participant Flow|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
61665|NCT02005211|P3|Participant Flow|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
61666|NCT02005211|P2|Participant Flow|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
61667|NCT02005211|P1|Participant Flow|Placebo Part 1|Placebo Part 1 - SAD
61668|NCT02005211|O7|Outcome|Placebo Part2|Placebo Part 2 - MAD
61669|NCT02005211|O6|Outcome|Placebo Part 1|Placebo Part 1 - SAD
61670|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
61671|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
61672|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
61673|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
61674|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
61675|NCT02005211|O7|Outcome|Placebo Part 2|Placebo Part 2 - MAD
61676|NCT02005211|O6|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
61677|NCT02005211|O5|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
61678|NCT02005211|O4|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
61679|NCT02005211|O3|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
61680|NCT02005211|O2|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
61681|NCT02005211|O1|Outcome|Placebo Part 1|Placebo Part 1 - SAD
61682|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
61683|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
61684|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
61685|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
61686|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
61687|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
61688|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
61689|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
61690|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
61691|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
61692|NCT02005211|E7|Reported Event|Placebo Part 2|Placebo Part 2 - MAD
61693|NCT02005211|E6|Reported Event|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
61694|NCT02005211|E5|Reported Event|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
61695|NCT02005211|E4|Reported Event|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
61696|NCT02005211|E3|Reported Event|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
61697|NCT02005211|E2|Reported Event|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
61698|NCT02005211|E1|Reported Event|Placebo Part 1|Placebo Part 1 - SAD
61699|NCT02005029|B3|Baseline|Total|Total of all reporting groups
61700|NCT02005029|B2|Baseline|Erythromycin Then Placebo|One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
61701|NCT02005029|B1|Baseline|Placebo First Then Erythromycin|One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
61702|NCT02005029|P2|Participant Flow|Erythromycin Then Placebo|One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
61703|NCT02005029|P1|Participant Flow|Placebo First Then Erythromycin|One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
61704|NCT02005029|O2|Outcome|Placebo|Cmax of plasma levodopa after placebo
61705|NCT02005029|O1|Outcome|Erythromycin|Cmax of plasma levodopa after erythromycin
61706|NCT02005029|O2|Outcome|Placebo|
61707|NCT02005029|O1|Outcome|Erythromycin|
61708|NCT02005029|O2|Outcome|Placebo|AIMS after receiving placebo
61709|NCT02005029|O1|Outcome|Erythromycin|AIMS after receiving erythromycin
61710|NCT02005029|O2|Outcome|Placebo|TUAG (fast speed) after placebo
61711|NCT02005029|O1|Outcome|Erythromycin|TUAG (fast speed) after erythromycin
61712|NCT02005029|O2|Outcome|Placebo|TUAG (comfortable speed) after placebo
61713|NCT02005029|O1|Outcome|Erythromycin|TUAG (comfortable speed) after erythromycin
61714|NCT02005029|O2|Outcome|Placebo|Mean CGS for all participants receiving placebo
61715|NCT02005029|O1|Outcome|Erythromycin|Mean CGS for all participants receiving erythromycin
61716|NCT02005029|O2|Outcome|Placebo|Five times sit-to-stand for all participants receiving placebo
61717|NCT02005029|O1|Outcome|Erythromycin|Five times sit-to-stand for all participants receiving erythromycin
61718|NCT02005029|O2|Outcome|Placebo|Mean time for right hand after placebo
61719|NCT02005029|O1|Outcome|Erythromycin|Mean time for right hand after erythromycin
61725|NCT02005029|O1|Outcome|Erythromycin|Mean gastric emptying time for participants receiving erythromycin
61726|NCT02005029|E2|Reported Event|Placebo|Participants who received a one time dose of placebo
89803|NCT01843374|O1|Outcome|TREMELIMUMAB|Tremelimumab 10mg/kg
61728|NCT02004990|B1|Baseline|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing
Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
61729|NCT02004990|P1|Participant Flow|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing
Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
61730|NCT02004990|O1|Outcome|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing
Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
61731|NCT02004990|O1|Outcome|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing
Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
61732|NCT02004990|E1|Reported Event|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing
Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
61733|NCT02004886|B5|Baseline|Total|Total of all reporting groups
61734|NCT02004886|B4|Baseline|Placebo|Placebo
61735|NCT02004886|B3|Baseline|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61736|NCT02004886|B2|Baseline|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61737|NCT02004886|B1|Baseline|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61738|NCT02004886|P4|Participant Flow|Placebo|Placebo
61739|NCT02004886|P3|Participant Flow|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61740|NCT02004886|P2|Participant Flow|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61741|NCT02004886|P1|Participant Flow|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61742|NCT02004886|O4|Outcome|Placebo|Placebo
61743|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61744|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61745|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61746|NCT02004886|O4|Outcome|Placebo|Placebo
61747|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61748|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61749|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61750|NCT02004886|O4|Outcome|Placebo|Placebo
61751|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61752|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61753|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61754|NCT02004886|O4|Outcome|Placebo|Placebo
61755|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61756|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61757|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61758|NCT02004886|O4|Outcome|Placebo|Placebo
61759|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61760|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61761|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61762|NCT02004886|O4|Outcome|Placebo|Placebo
61763|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61764|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61765|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61766|NCT02004886|O4|Outcome|Placebo|Placebo
61767|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61768|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61769|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61770|NCT02004886|O4|Outcome|Placebo|Placebo
61771|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61772|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61773|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61774|NCT02004886|O4|Outcome|Placebo|Placebo
61775|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61776|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61777|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61778|NCT02004886|O4|Outcome|Placebo|Placebo
61779|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61780|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61781|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61782|NCT02004886|O4|Outcome|Placebo|Placebo
61783|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61784|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61785|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61786|NCT02004886|E4|Reported Event|Placebo|Placebo
61787|NCT02004886|E3|Reported Event|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
61788|NCT02004886|E2|Reported Event|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
61789|NCT02004886|E1|Reported Event|MK-0893 (40 mg)|MK-0893 40-mg, once daily
61790|NCT02004873|B1|Baseline|Micra Study Enrollments|All subjects enrolled in the Micra study
61791|NCT02004873|P1|Participant Flow|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
61792|NCT02004873|O1|Outcome|Micra Subjects With Usable M-PREP Data|Subjects implanted with Micra who had usable M-PREP test(s) at 3-month and/or 6-month visits.
61793|NCT02004873|O1|Outcome|Micra Subjects With 6-month PCT Data|Subjects implanted with Micra who had paired ventricular capture management PCT and auto decrement PCT data available at the 6-month visit.
61878|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61794|NCT02004873|O1|Outcome|Micra Subjects With Implant and 6-month PCT Data|Subjects implanted with Micra who had paired implant and 6-month auto decrement PCT values (0.24 ms), or who had a system modification or alternative device implant prior to 6 months due to elevated threshold.
61795|NCT02004873|O1|Outcome|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
61796|NCT02004873|E1|Reported Event|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
61797|NCT02004847|B3|Baseline|Total|Total of all reporting groups
61798|NCT02004847|B2|Baseline|Low Intensity (LI) vs Control|"PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient.
PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light."
61799|NCT02004847|B1|Baseline|High Intensity (HI) vs Control|"PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient.
PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light."
61800|NCT02004847|P2|Participant Flow|Low Intensity (LI) vs. Control|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61801|NCT02004847|P1|Participant Flow|High Intensity (HI) vs. Control|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61802|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61803|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61804|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61805|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61806|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61807|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61808|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61809|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61810|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
61811|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity
61812|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
61813|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
61814|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61815|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61816|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61817|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61818|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61819|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61820|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61821|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61822|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient
61823|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61824|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
61825|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61826|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
61827|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61828|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
61829|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61830|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
61831|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity
61832|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
61833|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
61834|NCT02004847|O2|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
61835|NCT02004847|O1|Outcome|Low Intensity|PSO-CT02 device: Light wavelength 453nm, low intensity
61836|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
61842|NCT02004847|E2|Reported Event|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
61843|NCT02004847|E1|Reported Event|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
61844|NCT02004236|B4|Baseline|Total|Total of all reporting groups
61845|NCT02004236|B3|Baseline|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61846|NCT02004236|B2|Baseline|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61847|NCT02004236|B1|Baseline|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61848|NCT02004236|P3|Participant Flow|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61849|NCT02004236|P2|Participant Flow|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61850|NCT02004236|P1|Participant Flow|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61851|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61852|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61853|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61854|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61855|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61856|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61857|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61858|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61859|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61860|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61861|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61862|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61863|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61864|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61865|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61866|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61867|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61868|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61869|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61870|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61871|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61872|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61873|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61874|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61875|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61876|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61877|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61879|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61880|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61881|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61882|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61883|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61884|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61885|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61886|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61887|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61888|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61889|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61890|NCT02004236|E3|Reported Event|tRNS With Sham|"This group receive 35 sessions with sham
tRNS with sham: the subjects receive 35 session with sham"
61891|NCT02004236|E2|Reported Event|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex
tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
61892|NCT02004236|E1|Reported Event|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex
tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
61893|NCT02004158|B1|Baseline|Positive Psychology|Positive psychology intervention
61894|NCT02004158|P1|Participant Flow|Positive Psychology|Positive psychology intervention
61895|NCT02004158|O2|Outcome|Positive Psychology|Positive psychology intervention (8 week data)
61896|NCT02004158|O1|Outcome|Positive Psychology|Positive psychology intervention (Baseline data)
61897|NCT02004158|O1|Outcome|Positive Psychology|Positive psychology intervention
61898|NCT02004158|O1|Outcome|Positive Psychology|Positive psychology intervention
61899|NCT02004158|O1|Outcome|Positive Psychology|Positive psychology intervention
61900|NCT02004158|E1|Reported Event|Positive Psychology|Positive psychology intervention
61901|NCT02004132|B1|Baseline|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
61902|NCT02004132|P1|Participant Flow|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
61903|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
61904|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
61905|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
61906|NCT02004132|E1|Reported Event|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
61907|NCT02004093|B3|Baseline|Total|Total of all reporting groups
61908|NCT02004093|B2|Baseline|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61909|NCT02004093|B1|Baseline|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61910|NCT02004093|P2|Participant Flow|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61973|NCT02003404|P1|Participant Flow|Abdominal Skin Barrier Peel Force|"Barrier materials were attached and peeled off control and peristomal abdominal skin.
Three commercial barrier materials (SoftFlex, FlexWear and FlexTend) were peeled from control or peristomal abdominal skin after a set period at a set rate."
62351|NCT01999192|E2|Reported Event|100mg Dose Level 2 Tregalizumab|Dose Level 2 Tregalizumab (100mg)
61989|NCT02003391|E2|Reported Event|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
61990|NCT02003391|E1|Reported Event|DuoTrav|Travoprost/timolol for 8 weeks
62737|NCT01996748|P2|Participant Flow|Placebo|"Two administrations daily for 7 days
Placebo: Two administrations daily for 7 days"
61911|NCT02004093|P1|Participant Flow|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 milligrams (mg) intravenously (IV) on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/square meters (m^2) IV on Day 1 and carboplatin target area under the curve (AUC) 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61912|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61913|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61914|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61915|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61916|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61917|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61918|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61919|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen17 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61920|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61921|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61922|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61923|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61924|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61925|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61926|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61974|NCT02003404|O2|Outcome|Peristomal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.
61975|NCT02003404|O1|Outcome|Control Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.
61927|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61928|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61929|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61930|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61931|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off
61932|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61933|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61934|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61935|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61936|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
61937|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.
Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
61938|NCT02004093|E2|Reported Event|Chemotherapy|Participants received chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/ m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.
61939|NCT02004093|E1|Reported Event|Chemotherapy + Pertuzumab|Participants received loading dose of 840mg IV Pertuzumab, followed by 420 mg IV every 3 weeks (for a total of 17 cycles), along with chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles, followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.
61940|NCT02003963|B3|Baseline|Total|Total of all reporting groups
61941|NCT02003963|B2|Baseline|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
61942|NCT02003963|B1|Baseline|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
61943|NCT02003963|P2|Participant Flow|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
61976|NCT02003404|E2|Reported Event|Peristomal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.
61977|NCT02003404|E1|Reported Event|Control Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.
61978|NCT02003391|B3|Baseline|Total|Total of all reporting groups
61979|NCT02003391|B2|Baseline|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
61980|NCT02003391|B1|Baseline|DuoTrav|Travoprost/timolol for 8 weeks
61944|NCT02003963|P1|Participant Flow|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
Klub Kinect: Dance Central and Just Dance are a series of rhythm games developed by Harmonix Music Systems exclusively for the Xbox 360 Kinect. The Dance Central suite of games (Dance Central 1, 2, and 3) and Just Dance will be played on the Xbox 360+ Kinect gaming console, which employs whole body movement using an infrared sensor that tracks body movements such that an external controller device is not required. The player performs dance moves demonstrated by on-screen characters and set to popular music, with a choice of over 650 dance moves, 90 dance routines, and over 300 songs."
61945|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
61946|NCT02003963|O1|Outcome|Exergame Intervention|Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
61947|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
61948|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
61949|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
61950|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
61951|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
61952|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
61953|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
61954|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
61955|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
61956|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
61957|NCT02003963|E2|Reported Event|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
61958|NCT02003963|E1|Reported Event|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
61959|NCT02003638|B3|Baseline|Total|Total of all reporting groups
61960|NCT02003638|B2|Baseline|Placebo|Placebo taken orally every day for 12 weeks
61961|NCT02003638|B1|Baseline|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
61962|NCT02003638|P2|Participant Flow|Placebo|Placebo taken orally every day for 12 weeks
61963|NCT02003638|P1|Participant Flow|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
61964|NCT02003638|O2|Outcome|Placebo|Placebo taken orally every day for 12 weeks
61965|NCT02003638|O1|Outcome|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
61966|NCT02003638|E2|Reported Event|Placebo|Placebo taken orally every day for 12 weeks
61967|NCT02003638|E1|Reported Event|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
61968|NCT02003534|B1|Baseline|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
61969|NCT02003534|P1|Participant Flow|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
61970|NCT02003534|O1|Outcome|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
61971|NCT02003534|E1|Reported Event|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
61972|NCT02003404|B1|Baseline|Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend barrier were peeled from control or peristomal abdominal skin after a set period at a set rate.
61981|NCT02003391|P2|Participant Flow|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
61982|NCT02003391|P1|Participant Flow|DuoTrav|Travoprost/timolol for 8 weeks
61991|NCT02003352|B1|Baseline|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies
Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength.
The study population consisted of 98 combat veterans who had suffered aT BI with PTSD, referred to our study by Veteran’s groups. All subjects were male with a mean age of 39 years with a minimum age of 20 years and a maximum age of 60 years.They all met the inclusion requirements and did not have any of the exclusion requirements."
61992|NCT02003352|P1|Participant Flow|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies
Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
61993|NCT02003352|O1|Outcome|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies
Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
61994|NCT02003352|E1|Reported Event|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies
Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
61995|NCT02003014|B1|Baseline|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
61996|NCT02003014|P1|Participant Flow|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
61997|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
61998|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
61999|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
62000|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
62001|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
62002|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
62003|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
62004|NCT02003014|E1|Reported Event|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
62005|NCT02002936|B1|Baseline|SyB C-1101|"SyB C-1101 （rigosertib sodium）:
Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
62006|NCT02002936|P1|Participant Flow|SyB C-1101|"SyB C-1101 （rigosertib sodium）:
Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
62007|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:
Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
62008|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:
Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
62009|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:
Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
62010|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:
Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
62046|NCT02002702|P1|Participant Flow|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62352|NCT01999192|E1|Reported Event|25mg Dose Level 1 Tregalizumab|Dose Level 1 Tregalizumab (25mg)
62048|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
89804|NCT01843374|O2|Outcome|TREMELIMUMAB|TREMELIMUMAB 10 mg/kg
62011|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:
Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
62012|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:
Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
62013|NCT02002936|E1|Reported Event|SyB C-1101|"SyB C-1101 （rigosertib sodium）:
Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
62014|NCT02002871|B1|Baseline|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
62015|NCT02002871|P1|Participant Flow|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
62016|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62017|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
62018|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62019|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
62020|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62021|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
62022|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62023|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
62024|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62025|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
62026|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62027|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
62028|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62029|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
62030|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62031|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
62032|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62033|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
62034|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62035|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
62036|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62037|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
62038|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
62039|NCT02002871|E1|Reported Event|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.
PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
62040|NCT02002702|B4|Baseline|Total|Total of all reporting groups
62041|NCT02002702|B3|Baseline|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
62042|NCT02002702|B2|Baseline|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62043|NCT02002702|B1|Baseline|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62044|NCT02002702|P3|Participant Flow|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
62045|NCT02002702|P2|Participant Flow|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62047|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
62049|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62050|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
62051|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62052|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62053|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
62054|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62055|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62056|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
62057|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62058|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62059|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
62060|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62061|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62062|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
62063|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62064|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62065|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62066|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62067|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62068|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62069|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62070|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62071|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
62072|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62073|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62074|NCT02002702|E3|Reported Event|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
62075|NCT02002702|E2|Reported Event|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
62076|NCT02002702|E1|Reported Event|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
62077|NCT02002689|B1|Baseline|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
62078|NCT02002689|P1|Participant Flow|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
62079|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
62080|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
62081|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
62082|NCT02002689|E1|Reported Event|LDE225|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
62083|NCT02002650|B3|Baseline|Total|Total of all reporting groups
62084|NCT02002650|B2|Baseline|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.
Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
62085|NCT02002650|B1|Baseline|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.
Pre-operational rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
62086|NCT02002650|P2|Participant Flow|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.
Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
62087|NCT02002650|P1|Participant Flow|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.
Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
62088|NCT02002650|O2|Outcome|Post-ERCP Group|"Post-ERCP rectal Indomethacin for high-risk patients.
Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just for high-risk patients."
62089|NCT02002650|O1|Outcome|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.
Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
62090|NCT02002650|O2|Outcome|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.
Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
62091|NCT02002650|O1|Outcome|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.
Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
62092|NCT02002650|E2|Reported Event|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.
Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
62093|NCT02002650|E1|Reported Event|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.
Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
62094|NCT02002221|B3|Baseline|Total|Total of all reporting groups
62095|NCT02002221|B2|Baseline|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62096|NCT02002221|B1|Baseline|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62097|NCT02002221|P2|Participant Flow|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62098|NCT02002221|P1|Participant Flow|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62099|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62100|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62101|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62102|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62103|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62104|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62105|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62106|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62107|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62108|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62109|NCT02002221|E2|Reported Event|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62110|NCT02002221|E1|Reported Event|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
62111|NCT02002208|B3|Baseline|Total|Total of all reporting groups
62112|NCT02002208|B2|Baseline|Placebo Tablets|"Orally once a day
OC000459: CRTH2 inhibitor"
62113|NCT02002208|B1|Baseline|OC000459 Tablets|"50 mg orally once a day
OC000459: CRTH2 inhibitor"
62114|NCT02002208|P2|Participant Flow|Placebo Tablets|"Orally once a day
OC000459: CRTH2 inhibitor"
62115|NCT02002208|P1|Participant Flow|OC000459 Tablets|"50 mg orally once a day
OC000459: CRTH2 inhibitor"
62116|NCT02002208|O2|Outcome|Placebo Tablets|Orally once a day
62117|NCT02002208|O1|Outcome|OC000459 Tablets|"50 mg orally once a day
OC000459: CRTH2 inhibitor"
62118|NCT02002208|O2|Outcome|Placebo Tablets|Orally once a day
62119|NCT02002208|O1|Outcome|OC000459 Tablets|"50 mg orally once a day
OC000459: CRTH2 inhibitor"
62120|NCT02002208|E2|Reported Event|Placebo Tablets|Orally once a day
62121|NCT02002208|E1|Reported Event|OC000459 Tablets|"50 mg orally once a day
OC000459: CRTH2 inhibitor"
62122|NCT02001181|B3|Baseline|Total|Total of all reporting groups
62123|NCT02001181|B2|Baseline|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
62353|NCT01998919|B3|Baseline|Total|Total of all reporting groups
62124|NCT02001181|B1|Baseline|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
62125|NCT02001181|P2|Participant Flow|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
62126|NCT02001181|P1|Participant Flow|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
62127|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
62128|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
62129|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
62130|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
62131|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
62132|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
62133|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
62134|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
62135|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
62136|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
62137|NCT02001181|E2|Reported Event|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
62138|NCT02001181|E1|Reported Event|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
62139|NCT02000973|B5|Baseline|Total|Total of all reporting groups
62140|NCT02000973|B4|Baseline|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine
62141|NCT02000973|B3|Baseline|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine
62142|NCT02000973|B2|Baseline|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine
62143|NCT02000973|B1|Baseline|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline
62144|NCT02000973|P4|Participant Flow|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine
62145|NCT02000973|P3|Participant Flow|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine
62146|NCT02000973|P2|Participant Flow|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine
62147|NCT02000973|P1|Participant Flow|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline
62148|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
62149|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
62150|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
62151|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
62152|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
62153|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
62154|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
62155|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
62156|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
62157|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
62158|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
62159|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
62160|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
62161|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
62162|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
62163|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
62164|NCT02000973|E4|Reported Event|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
62165|NCT02000973|E3|Reported Event|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
62166|NCT02000973|E2|Reported Event|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
62167|NCT02000973|E1|Reported Event|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
62168|NCT02000921|B4|Baseline|Total|Total of all reporting groups
62169|NCT02000921|B3|Baseline|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62286|NCT01999400|E3|Reported Event|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose
Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
62287|NCT01999400|E2|Reported Event|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose
Apriso 375 mg capsule x 3 with 240 mL water; single dose"
62292|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
62170|NCT02000921|B2|Baseline|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62171|NCT02000921|B1|Baseline|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content."
62172|NCT02000921|P3|Participant Flow|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62173|NCT02000921|P2|Participant Flow|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62174|NCT02000921|P1|Participant Flow|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content."
62175|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62176|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62177|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content."
62178|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62179|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62180|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content."
62181|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62288|NCT01999400|E1|Reported Event|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose
Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
62289|NCT01999348|B1|Baseline|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
62182|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62183|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content."
62184|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62185|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62186|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content."
62187|NCT02000921|E3|Reported Event|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes: Modified risk tobacco product
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62188|NCT02000921|E2|Reported Event|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes: Modified risk tobacco product
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
62189|NCT02000921|E1|Reported Event|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes: Experimental cigarettes with conventional nicotine content."
62190|NCT02000752|B3|Baseline|Total|Total of all reporting groups
62191|NCT02000752|B2|Baseline|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.
Sham acupuncture: Sham point acupuncture"
62192|NCT02000752|B1|Baseline|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.
Acupuncture"
62193|NCT02000752|P2|Participant Flow|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.
Acupuncture"
62194|NCT02000752|P1|Participant Flow|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.
Sham acupuncture: Sham point acupuncture"
62290|NCT01999348|P1|Participant Flow|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
62195|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.
Acupuncture"
62196|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.
Sham acupuncture: Sham point acupuncture"
62197|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.
Acupuncture"
62198|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.
Sham acupuncture: Sham point acupuncture"
62199|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.
Acupuncture"
62200|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.
Sham acupuncture: Sham point acupuncture"
62201|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.
Acupuncture"
62202|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.
Sham acupuncture: Sham point acupuncture"
62203|NCT02000752|E2|Reported Event|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.
Acupuncture"
62204|NCT02000752|E1|Reported Event|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.
Sham acupuncture: Sham point acupuncture"
62205|NCT02000531|B3|Baseline|Total|Total of all reporting groups
62206|NCT02000531|B2|Baseline|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
62207|NCT02000531|B1|Baseline|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
62208|NCT02000531|P2|Participant Flow|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
62209|NCT02000531|P1|Participant Flow|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
62210|NCT02000531|O2|Outcome|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
62211|NCT02000531|O1|Outcome|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
62212|NCT02000531|O2|Outcome|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
62213|NCT02000531|O1|Outcome|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
62214|NCT02000531|E2|Reported Event|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
62215|NCT02000531|E1|Reported Event|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
89805|NCT01843374|O1|Outcome|PLACEBO|Placebo.
62216|NCT02000440|B1|Baseline|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62217|NCT02000440|P1|Participant Flow|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62218|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62219|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62220|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62221|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62222|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62223|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62224|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62225|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62226|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62227|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62228|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62229|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62230|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62291|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
62231|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62232|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62233|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62234|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62235|NCT02000440|E1|Reported Event|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
62236|NCT02000427|B1|Baseline|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62237|NCT02000427|P1|Participant Flow|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62238|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62239|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62240|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62241|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62242|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62243|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62244|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62245|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62246|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62247|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62248|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62249|NCT02000427|O1|Outcome|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62250|NCT02000427|E1|Reported Event|Blinatumomab|"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment."
62251|NCT02000154|B1|Baseline|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:
A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
62252|NCT02000154|P1|Participant Flow|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:
A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
62253|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:
A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
62254|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:
A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
62255|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:
A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
62256|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:
A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
62257|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:
A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
62258|NCT02000154|E1|Reported Event|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:
A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
62259|NCT01999894|B1|Baseline|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
62260|NCT01999894|P1|Participant Flow|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
62261|NCT01999894|O1|Outcome|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
62262|NCT01999894|E2|Reported Event|Memantine to Memantine|Patients who received Memantine during the double-blind lead-in study continued to receive Memantine during a 6-week lead-in, followed by 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
62263|NCT01999894|E1|Reported Event|Placebo to Memantine|Patients who received placebo during the double-blind lead-in study, were titrated to Memantine during a 6-week lead-in to 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
62264|NCT01999400|B1|Baseline|All Study Participants|"Participants who were randomized to one of the six arms of this study:
Arm 1: Pentasa then Delzicol then Apriso then Lialda Arm 2: Pentasa then Delzicol then Lialda then Apriso Arm 3: Apriso then Delzicol then Pentasa then Lialda Arm 4: Apriso then Delzicol then Lialda then Pentasa Arm 5: Lialda then Delzicol then Pentasa then Apriso Arm 6: Lialda then Delzicol then Apriso then Pentasa"
62265|NCT01999400|P6|Participant Flow|Arm 6: Lialda Then Delzicol Then Apriso Then Pentasa|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
Washout period of 10 days.
Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
Washout period of 10 days.
Apriso 375 mg capsule x 3 with 240 mL water, single dose.
Washout period of 10 days.
Pentasa 500 mg capsule x 2 with 240 mL water, single dose."
62266|NCT01999400|P5|Participant Flow|Arm 5: Lialda Then Delzicol Then Pentasa Then Apriso|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
Washout period of 10 days.
Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
Washout period of 10 days.
Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
Washout period of 10 days.
Apriso 375 mg capsule x 3 with 240 mL water, single dose."
62267|NCT01999400|P4|Participant Flow|Arm 4: Apriso Then Delzicol Then Lialda Then Pentasa|"Apriso 375 mg capsule x 3 with 240 mL water, single dose.
Washout period of 10 days.
Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
Washout period of 10 days.
Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
Washout period of 10 days.
Pentasa 500 mg capsule x 2 with 240 mL water, single dose."
62268|NCT01999400|P3|Participant Flow|Arm 3: Apriso Then Delzicol Then Pentasa Then Lialda|"Apriso 375 mg capsule x 3 with 240 mL water, single dose.
Washout period of 10 days.
Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
Washout period of 10 days.
Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
Washout period of 10 days.
Lialda 1200 mg tablet x 1 with 240 mL water, single dose."
62269|NCT01999400|P2|Participant Flow|Arm 2: Pentasa Then Delzicol Then Lialda Then Apriso|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
Washout period of 10 days.
Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
Washout period of 10 days.
Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
Washout period of 10 days.
Apriso 375 mg capsule x 3 with 240 mL water, single dose."
62270|NCT01999400|P1|Participant Flow|Arm 1: Pentasa Then Delzicol Then Apriso Then Lialda|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
Washout period of 10 days.
Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
Washout period of 10 days.
Apriso 375 mg capsule x 3 with 240 mL water, single dose.
Washout period of 10 days.
Lialda 1200 mg tablet x 1 with 240 mL water, single dose."
62271|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose
Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
62272|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose
Apriso 375 mg capsule x 3 with 240 mL water; single dose"
62273|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose
Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
62274|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose
Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
62275|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose
Apriso 375 mg capsule x 3 with 240 mL water; single dose"
62276|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose
Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
62277|NCT01999400|O4|Outcome|Delzicol|"Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose
Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose"
62278|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose
Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
62279|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose
Apriso 375 mg capsule x 3 with 240 mL water; single dose"
62280|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose
Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
62281|NCT01999400|O4|Outcome|Delzicol|"Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose
Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose"
62282|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose
Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
62283|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose
Apriso 375 mg capsule x 3 with 240 mL water; single dose"
62284|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose
Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
62285|NCT01999400|E4|Reported Event|Delzicol|"Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose
Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose"
62293|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
62294|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
62295|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
62296|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
62297|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
62298|NCT01999348|E1|Reported Event|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
62299|NCT01999231|B5|Baseline|Total|Total of all reporting groups
62300|NCT01999231|B4|Baseline|20μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
62301|NCT01999231|B3|Baseline|10μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
62302|NCT01999231|B2|Baseline|5μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
62303|NCT01999231|B1|Baseline|1μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
62304|NCT01999231|P4|Participant Flow|20μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .
Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes ."
62305|NCT01999231|P3|Participant Flow|10μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .
Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .
Make sure 10μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 20μg/ml ESAT6-CFP10 groups ."
62306|NCT01999231|P2|Participant Flow|5μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .
Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .
Make sure 5μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 10μg/ml ESAT6-CFP10 groups ."
62307|NCT01999231|P1|Participant Flow|1μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .
Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .
Make sure 1μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 5μg/ml ESAT6-CFP10 groups ."
62308|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62735|NCT01996748|B2|Baseline|Placebo|"Two administrations daily for 7 days
Placebo: Two administrations daily for 7 days"
62309|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62310|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62311|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62312|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62313|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62314|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62315|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62316|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62317|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62318|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62319|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62320|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
62321|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62322|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62323|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62324|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62325|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62326|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62327|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62328|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
62329|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62330|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62331|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
62332|NCT01999231|E4|Reported Event|20μg/ml ESAT6-CFP10|There is no adverse event.
62333|NCT01999231|E3|Reported Event|10μg/ml ESAT6-CFP10|There is no adverse event.
62334|NCT01999231|E2|Reported Event|5μg/ml ESAT6-CFP10|"Medicine Number 2 participant 15 min and 30 min after skin test is observed local skin reactions and all found that scattered red dot (32 x 25 mm )appeared .After 30min each time point local skin reactions were negative .
This mild local skin reactions may be relevant with alcohol allergy , had nothing to do with experimental drugs by the judgement of principal investigator ."
62335|NCT01999231|E1|Reported Event|1μg/ml ESAT6-CFP10|"Medicine Number 6 participant 24 h after test skin test, is observed local skin reactions and found subcutaneous hemorrhage ( 2 x 2 mm),48 h the subcutaneous hemorrhage is remain and becomes shallow ,72 h the subcutaneous hemorrhage is the same size and becomes lower shallow ,96 h the skin reaction has faded .This mild local skin reactions may be relevant with acupuncture of skin test , had nothing to do with experimental drugs by the judgement of principal investigator .
Medicine Number 12 participant occurred two cases of adverse events the seventh days after skin test :respectively pregnancy and a small amount of pleural effusion on both sides .This volunteer test results of a pregnancy test paper were negative in screening period,pregnancy test result were positive the seventh days after the skin test."
62336|NCT01999192|B5|Baseline|Total|Total of all reporting groups
62337|NCT01999192|B4|Baseline|Placebo|Placebo s.c. weekly
62338|NCT01999192|B3|Baseline|Dose Level 3 Tregalizumab|200mg Tregalizumab s.c. weekly
62339|NCT01999192|B2|Baseline|Dose Level 2 Tregalizumab|100mg Tregalizumab s.c. weekly
62340|NCT01999192|B1|Baseline|Dose Level 1 Tregalizumab|25mg Tregalizumab s.c. weekly
62341|NCT01999192|P4|Participant Flow|Placebo|Placebo s.c. weekly
62342|NCT01999192|P3|Participant Flow|Dose Level 3 Tregalizumab|200mg Tregalizumab s.c. weekly
62343|NCT01999192|P2|Participant Flow|Dose Level 2 Tregalizumab|100mg Tregalizumab s.c. weekly
62344|NCT01999192|P1|Participant Flow|Dose Level 1 Tregalizumab|25mg Tregalizumab s.c. weekly
62345|NCT01999192|O4|Outcome|Placebo|Placebo s.c. weekly
62346|NCT01999192|O3|Outcome|Dose Level 3 Tregalizumab|200mg Tregalizumab s.c. weekly
62347|NCT01999192|O2|Outcome|Dose Level 2 Tregalizumab|100mg Tregalizumab s.c. weekly
62348|NCT01999192|O1|Outcome|Dose Level 1 Tregalizumab|25mg Tregalizumab s.c. weekly
62349|NCT01999192|E4|Reported Event|Placebo|Placebo -
62350|NCT01999192|E3|Reported Event|200mg Dose Level 3 Tregalizumab|Dose Level 3 Tregalizumab (200mg)
62736|NCT01996748|B1|Baseline|DF277|"Two administrations daily for 7 days
DF277: Two administrations daily for 7 days"
62354|NCT01998919|B2|Baseline|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
62355|NCT01998919|B1|Baseline|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
62356|NCT01998919|P2|Participant Flow|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
62357|NCT01998919|P1|Participant Flow|Placebo Plus Chemotherapy|Participants received placebo tablets, orally (PO), on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 times [x] area under the serum concentration-time curve [AUC]), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
62358|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
62359|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
62360|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
62361|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
62362|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
62363|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
62364|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
62365|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
62391|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62366|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
62367|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
62368|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
62369|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
62370|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
62371|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
62372|NCT01998919|E2|Reported Event|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
62373|NCT01998919|E1|Reported Event|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
62374|NCT01998906|B4|Baseline|Total|Total of all reporting groups
62375|NCT01998906|B3|Baseline|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62376|NCT01998906|B2|Baseline|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62377|NCT01998906|B1|Baseline|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62378|NCT01998906|P3|Participant Flow|HER2- Doxorubicin/Paclitaxel/CMF (HER2-C)|"Participants with human epidermal growth factor receptor proto-oncogene negative (HER2-) breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62436|NCT01998880|P2|Participant Flow|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
62974|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62379|NCT01998906|P2|Participant Flow|HER2+ Doxorubicin/Paclitaxel/CMF (HER2+C)|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62380|NCT01998906|P1|Participant Flow|HER2+ Trastuzumab/Doxorubicin/Paclitaxel/CMF (HER2+TC)|"Participants with human epidermal growth factor receptor 2 proto-oncogene positive (HER2+) breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/square meter (mg/m^2), IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62381|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62382|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62383|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62384|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62385|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62386|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62387|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62388|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62389|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62390|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62716|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
62392|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62393|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62394|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62395|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62396|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62397|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62398|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62399|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62400|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62401|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62402|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received doxorubicin, paclitaxel, and CMF as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Day 1, followed by 2 weeks off."
62403|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received doxorubicin, paclitaxel and CMF as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Day 1, followed by 2 weeks off."
62438|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
62404|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62405|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62406|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62407|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62408|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62409|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62410|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62411|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62412|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62413|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62414|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62415|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62437|NCT01998880|P1|Participant Flow|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
62416|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62417|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62418|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62419|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62420|NCT01998906|E3|Reported Event|HER2- C|"Participants with HER2- breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62421|NCT01998906|E2|Reported Event|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
62422|NCT01998906|E1|Reported Event|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
62423|NCT01998893|B1|Baseline|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
62424|NCT01998893|P1|Participant Flow|Rituximab|Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
62425|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
62426|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
62427|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
62428|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
62429|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
62430|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
62431|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
62432|NCT01998893|E1|Reported Event|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
62433|NCT01998880|B3|Baseline|Total|Total of all reporting groups
62434|NCT01998880|B2|Baseline|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
62435|NCT01998880|B1|Baseline|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
89806|NCT01843374|E2|Reported Event|TREMELIMUMAB|Tremelimumab 10mg/kg
62439|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
62440|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
62441|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
62442|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
62443|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
62444|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
62445|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
62446|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
62447|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
62448|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
62449|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
62450|NCT01998880|E2|Reported Event|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
62451|NCT01998880|E1|Reported Event|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
62452|NCT01998737|B3|Baseline|Total|Total of all reporting groups
62453|NCT01998737|B2|Baseline|Healthy Women|
62454|NCT01998737|B1|Baseline|Women Under Osteoporosis Suspicion|
62455|NCT01998737|P2|Participant Flow|Healthy Women|In healthy group females without risk factors for fracture or diseases affecting bone health were recruited.
62456|NCT01998737|P1|Participant Flow|Women Under Osteoporosis Suspicion|Subjects with at least one risk factor for osteoporotic fracture.
62457|NCT01998737|O2|Outcome|Healthy Women|As defined in the protocol
62458|NCT01998737|O1|Outcome|Women Under Osteoporosis Suspicion|As defined in the protocol
62459|NCT01998737|O2|Outcome|Healthy Women|As defined in the protocol
62460|NCT01998737|O1|Outcome|Women Under Osteoporosis Suspicion|As defined in the protocol
62461|NCT01998737|O2|Outcome|Healthy Women|As defined in the protocol
62462|NCT01998737|O1|Outcome|Women Under Osteoporosis Suspicion|As defined in the protocol
62463|NCT01998737|E2|Reported Event|Healthy Women|
62464|NCT01998737|E1|Reported Event|Women Under Osteoporosis Suspicion|
62465|NCT01998581|B3|Baseline|Total|Total of all reporting groups
62466|NCT01998581|B2|Baseline|Restylane-L®|Lips injected with Restylane-L®
62467|NCT01998581|B1|Baseline|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
62468|NCT01998581|P2|Participant Flow|Restylane-L®|Lips injected with Restylane-L®
62469|NCT01998581|P1|Participant Flow|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
62470|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
62471|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
62472|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
62473|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
62474|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
62475|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
62476|NCT01998581|E2|Reported Event|Restylane-L®|Lips injected with Restylane-L®
62477|NCT01998581|E1|Reported Event|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
62478|NCT01998477|B3|Baseline|Total|Total of all reporting groups
62479|NCT01998477|B2|Baseline|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
62480|NCT01998477|B1|Baseline|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62481|NCT01998477|P2|Participant Flow|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
62717|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
62482|NCT01998477|P1|Participant Flow|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62483|NCT01998477|O8|Outcome|TIV_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
62484|NCT01998477|O7|Outcome|TIV_Non Naive (3 to <9 Years)|Vaccine non naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
62485|NCT01998477|O6|Outcome|TIV_Naive (3 to <9 Years)|Vaccine naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
62486|NCT01998477|O5|Outcome|TIVc_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62487|NCT01998477|O4|Outcome|TIVc_Non Naive (3 to <9 Years)|Vaccine non naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62488|NCT01998477|O3|Outcome|TIVc_Naive (3 to <9 Years)|Vaccine naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62489|NCT01998477|O2|Outcome|TIV (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
62490|NCT01998477|O1|Outcome|TIVc (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62491|NCT01998477|O14|Outcome|TIV_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
62492|NCT01998477|O13|Outcome|TIVc_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62493|NCT01998477|O12|Outcome|TIV_Naive_inj 2 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
62494|NCT01998477|O11|Outcome|TIV_Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
62495|NCT01998477|O10|Outcome|TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine non-naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
62496|NCT01998477|O9|Outcome|TIVc_Naive_inj 2 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62497|NCT01998477|O8|Outcome|TIVc_Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62498|NCT01998477|O7|Outcome|TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)|Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62499|NCT01998477|O6|Outcome|TIV_naive_inj 2 (3 to <6 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
62500|NCT01998477|O5|Outcome|TIV_naive_inj 1 (3 to <6 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
62501|NCT01998477|O4|Outcome|TIV_Non naive_inj 1 (3 to <6 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
62502|NCT01998477|O3|Outcome|TIVc_naive_inj 2 (3 to <6 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62503|NCT01998477|O2|Outcome|TIVc_naive_inj 1 (3 to <6 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62504|NCT01998477|O1|Outcome|TIVc_Non naive_inj 1 (3 to <6 Years)|Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62505|NCT01998477|O4|Outcome|TIV_inj 2 (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
62506|NCT01998477|O3|Outcome|TIV_inj 1 (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
62507|NCT01998477|O2|Outcome|TIVc_inj 2 (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62508|NCT01998477|O1|Outcome|TIVc _inj 1 (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
62509|NCT01998477|E3|Reported Event|Total|Total Number of subjects
62510|NCT01998477|E2|Reported Event|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
62511|NCT01998477|E1|Reported Event|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc).
62512|NCT01998438|B4|Baseline|Total|Total of all reporting groups
62513|NCT01998438|B3|Baseline|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62514|NCT01998438|B2|Baseline|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62515|NCT01998438|B1|Baseline|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62516|NCT01998438|P3|Participant Flow|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62517|NCT01998438|P2|Participant Flow|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62718|NCT01997216|E2|Reported Event|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
62518|NCT01998438|P1|Participant Flow|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62519|NCT01998438|O3|Outcome|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62520|NCT01998438|O2|Outcome|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62521|NCT01998438|O1|Outcome|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62522|NCT01998438|E3|Reported Event|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62523|NCT01998438|E2|Reported Event|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62524|NCT01998438|E1|Reported Event|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision."
62525|NCT01998399|B3|Baseline|Total|Total of all reporting groups
62526|NCT01998399|B2|Baseline|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.
Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
62527|NCT01998399|B1|Baseline|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days
Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
62528|NCT01998399|P2|Participant Flow|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.
Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
62529|NCT01998399|P1|Participant Flow|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days
Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
62530|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.
Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
62531|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days
Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
62532|NCT01998399|E2|Reported Event|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.
Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
62533|NCT01998399|E1|Reported Event|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days
Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
62534|NCT01998360|B3|Baseline|Total|Total of all reporting groups
62535|NCT01998360|B2|Baseline|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
62536|NCT01998360|B1|Baseline|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
62537|NCT01998360|P2|Participant Flow|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
62538|NCT01998360|P1|Participant Flow|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
62539|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
62540|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
62541|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
62542|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
62543|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
62544|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
62545|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
62546|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
62547|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
62548|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
62549|NCT01998360|E2|Reported Event|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
62550|NCT01998360|E1|Reported Event|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
62551|NCT01998269|B1|Baseline|Adult Patients With Diabetes and Hypertension|There are no study arms. This was a cross-sectional study to develop a scale.
62552|NCT01998269|P1|Participant Flow|Adult Patients With Diabetes and Hypertension|English-speaking, adult patients with diabetes and hypertension. There are no study arms - this was a cross-sectional study to develop and validate a measure of medication self-management skills. A total of 210 patients were recruited. 17 participated in focus groups to help develop the tool. The other 193 participated in item performance testing. The results of item performance testing are reported here.
62553|NCT01998269|O1|Outcome|Adult Patients With Diabetes and Hypertension|English-speaking, adult patients with diabetes and hypertension were enrolled in the study. There are no study arms.
62554|NCT01998269|E1|Reported Event|Adult Patients With Diabetes and Hypertension|There are no study arms. This was a cross-sectional study to develop a medication self-management scale.
62555|NCT01997905|B1|Baseline|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device"
62556|NCT01997905|P1|Participant Flow|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device"
62557|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device"
62558|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device"
62559|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device"
62560|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device"
62561|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device"
62562|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device"
62563|NCT01997905|E1|Reported Event|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device"
62564|NCT01997892|B1|Baseline|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
62565|NCT01997892|P1|Participant Flow|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEGylated (PEG) epoetin beta immediately prior to being switched to darbepoetin alfa.
62566|NCT01997892|O2|Outcome|Excursions > 12.0 g/dL|Hemoglobin excursions above 12.0 g/dL
62567|NCT01997892|O1|Outcome|Excursions <10.0 g/dL|Hemoglobin excursions below 10.0 g/dL
62568|NCT01997892|O2|Outcome|Post-switch Period|From the date of the switch to darbepoetin alfa, until up to 6 months.
62569|NCT01997892|O1|Outcome|Pre-switch Period|From 3 months prior to the switch until the date of the switch to darbepoetin alfa.
62570|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
62571|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
62572|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
62573|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
62574|NCT01997892|E2|Reported Event|Post-switch Period|From the date of the switch to darbepoetin alfa, until up to 6 months.
62575|NCT01997892|E1|Reported Event|Pre-switch Period|From 3 months prior to the switch until the date of the switch to darbepoetin alfa.
62576|NCT01997723|B1|Baseline|OSA Testing|"Cross-over design, single group/arm
Interventions:
One polysomnography one laboratory Portable monitoring simultaneously with polysomnography one home Portable monitoring"
62577|NCT01997723|P1|Participant Flow|Experimental|"Cross-over design, single group/arm
Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
62578|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm
Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
62579|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm
Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
62580|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm
Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
62581|NCT01997723|E1|Reported Event|OSA Testing|"Cross-over design, single group/arm
Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
62582|NCT01997567|B3|Baseline|Total|Total of all reporting groups
62719|NCT01997216|E1|Reported Event|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
62720|NCT01996904|B3|Baseline|Total|Total of all reporting groups
62583|NCT01997567|B2|Baseline|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
62584|NCT01997567|B1|Baseline|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)
Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
62585|NCT01997567|P2|Participant Flow|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
62586|NCT01997567|P1|Participant Flow|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)
Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
62587|NCT01997567|O2|Outcome|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
62588|NCT01997567|O1|Outcome|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)
Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
62589|NCT01997567|E2|Reported Event|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
62590|NCT01997567|E1|Reported Event|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)
Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
62591|NCT01997437|B1|Baseline|Tissue-engineered Airway Transplantation|"Stem-cell seeded bioartificial tracheal scaffold
Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ"
62592|NCT01997437|P1|Participant Flow|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
62593|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
62594|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
62595|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
62596|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
62597|NCT01997437|E1|Reported Event|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
62598|NCT01997411|B6|Baseline|Total|Total of all reporting groups
62599|NCT01997411|B5|Baseline|12 to <17 Years Old IN/IM Cohort|Participants who were 12 to < 17 years old at the time of enrollment into the study randomized to receive either intramuscular glucagon or intranasal glucagon at two separate visits. Order of these visits was randomized.
62600|NCT01997411|B4|Baseline|8 to <12 Years Old Intranasal Glucagon Cohort|Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of intranasal glucagon at two separate visits. Order of these visits was randomized.
62601|NCT01997411|B3|Baseline|8 to <12 Years Old Intramuscular Glucagon Cohort|Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
62602|NCT01997411|B2|Baseline|4 to <8 Years Old Intranasal Glucagon Cohort|Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of intranasal glucagon at two separate visits. Order of these visits was randomized.
62603|NCT01997411|B1|Baseline|4 to <8 Years Old Intramuscular Glucagon Cohort|Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
62604|NCT01997411|P8|Participant Flow|12 to <17 Years IM Glucagon 1st Visit/IN Glucagon 2nd Visit|"At the first visit, participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
At the second visit, an intranasal (IN) glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
62605|NCT01997411|P7|Participant Flow|12 to <17 Years IN Glucagon 1st Visit/IM Glucagon 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
At the second visit, participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution."
62606|NCT01997411|P6|Participant Flow|8 to <12 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
At the second visit, an IN glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
62607|NCT01997411|P5|Participant Flow|8 to <12 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
At the second visit, an IN glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
62608|NCT01997411|P4|Participant Flow|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62609|NCT01997411|P3|Participant Flow|4 to <8 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
At the second visit, an IN glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
62649|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62610|NCT01997411|P2|Participant Flow|4 to <8 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
At the second visit, an IN glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
62611|NCT01997411|P1|Participant Flow|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62612|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62613|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
62614|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62615|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62616|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62617|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62618|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62619|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62620|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62621|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
62622|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62623|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62624|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62625|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62626|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62627|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62628|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62715|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
62629|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
62630|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62631|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62632|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62633|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62634|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62635|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62636|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62637|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
62638|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62639|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62640|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62641|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62642|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62643|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62644|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62645|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
62646|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62647|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62648|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62650|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62651|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62652|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62653|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
62654|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62655|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62656|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62657|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62658|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62659|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62660|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62661|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
62662|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62663|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62664|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62665|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62666|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62667|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62668|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62669|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
62670|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62671|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62672|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62673|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62674|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62675|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62676|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62677|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
62678|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62679|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62680|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62681|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62682|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62683|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62684|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62685|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
62686|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62687|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62688|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62689|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62734|NCT01996748|B3|Baseline|Total|Total of all reporting groups
62690|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62691|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62692|NCT01997411|E8|Reported Event|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62693|NCT01997411|E7|Reported Event|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
62694|NCT01997411|E6|Reported Event|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62695|NCT01997411|E5|Reported Event|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62696|NCT01997411|E4|Reported Event|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62697|NCT01997411|E3|Reported Event|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62698|NCT01997411|E2|Reported Event|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62699|NCT01997411|E1|Reported Event|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
62700|NCT01997398|B1|Baseline|DBS Under General Anesthesia|Patients with advanced Parkinson's disease who underwent bilateral globus pallidus interna (GPi) deep brain stimulation surgery under general anesthesia without the use of microelectrode recordings or intraoperative stimulation.
62701|NCT01997398|P1|Participant Flow|Bilateral GPi DBS Surgery Under General Anesthesia|Patients underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
62702|NCT01997398|O2|Outcome|Post - DBS Bilateral GPi DBS Surgery Under General Anesthesia|Patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
62703|NCT01997398|O1|Outcome|Pre-DBS Bilateral GPi DBS Surgery Under General Anesthesia|Patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
62704|NCT01997398|O4|Outcome|"Post-DBS Bilateral GPi DBS Under General Anesthesia On Med"|"On medication scores of patients who underwent bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
62705|NCT01997398|O3|Outcome|"Pre-DBS Bilateral GPi DBS Under General Anesthesia On Med"|"On medication scores of patients scheduled for bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
62706|NCT01997398|O2|Outcome|"Post-DBS Bilateral GPi DBS Under General Anesthesia Off Med"|"Off medication UPDRS III scores of patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
62707|NCT01997398|O1|Outcome|"Pre-DBS Bilateral GPi DBS Under General Anesthesia Off Med"|"Off  medication UPDRS III scores of patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
Off medication ."
62708|NCT01997398|E1|Reported Event|Bilateral GPi DBS Surgery Under General Anesthesia|Patients underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
62709|NCT01997216|B1|Baseline|Overall|Delefilcon A multifocal contact lenses and lotrafilcon B multifocal contact lenses, worn as randomized for 9 hours each.
62710|NCT01997216|P2|Participant Flow|AOAMF, Then Delefilcon A MF|Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
62711|NCT01997216|P1|Participant Flow|Delefilcon A MF, Then AOAMF|Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
62712|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
62713|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
62714|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
62721|NCT01996904|B2|Baseline|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
62722|NCT01996904|B1|Baseline|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.
arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
62723|NCT01996904|P2|Participant Flow|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
62724|NCT01996904|P1|Participant Flow|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.
If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
62725|NCT01996904|O2|Outcome|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
62726|NCT01996904|O1|Outcome|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.
arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
62727|NCT01996904|E2|Reported Event|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
62728|NCT01996904|E1|Reported Event|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.
arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
62729|NCT01996813|B1|Baseline|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.
Compression Hose: Intervention in this case is placement of compression hose on patients"
62730|NCT01996813|P1|Participant Flow|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.
Compression Hose: Intervention in this case is placement of compression hose on patients"
62731|NCT01996813|O1|Outcome|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.
Compression Hose: Intervention in this case is placement of compression hose on patients"
62732|NCT01996813|O1|Outcome|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.
Compression Hose: Intervention in this case is placement of compression hose on patients"
62733|NCT01996813|E1|Reported Event|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.
Compression Hose: Intervention in this case is placement of compression hose on patients"
62738|NCT01996748|P1|Participant Flow|DF277|"Two administrations daily for 7 days
DF277: Two administrations daily for 7 days"
62739|NCT01996748|O2|Outcome|Placebo|"Two administrations daily for 7 days
Placebo: Two administrations daily for 7 days"
62740|NCT01996748|O1|Outcome|DF277|"Two administrations daily for 7 days
DF277: Two administrations daily for 7 days"
62741|NCT01996748|O2|Outcome|Placebo|"Two administrations daily for 7 days
Placebo: Two administrations daily for 7 days"
62742|NCT01996748|O1|Outcome|DF277|"Two administrations daily for 7 days
DF277: Two administrations daily for 7 days"
62743|NCT01996748|O2|Outcome|Placebo|Two administrations daily for 7 days
62744|NCT01996748|O1|Outcome|DF277|Two administrations daily for 7 days
62745|NCT01996748|O2|Outcome|Placebo|"Two administrations daily for 7 days
Placebo: Two administrations daily for 7 days"
62746|NCT01996748|O1|Outcome|DF277|"Two administrations daily for 7 days
DF277: Two administrations daily for 7 days"
62747|NCT01996748|E2|Reported Event|Placebo|"Two administrations daily for 7 days
Placebo: Two administrations daily for 7 days"
62748|NCT01996748|E1|Reported Event|DF277|"Two administrations daily for 7 days
DF277: Two administrations daily for 7 days"
62749|NCT01996709|B3|Baseline|Total|Total of all reporting groups
62750|NCT01996709|B2|Baseline|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
62751|NCT01996709|B1|Baseline|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
62752|NCT01996709|P2|Participant Flow|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
62753|NCT01996709|P1|Participant Flow|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
62754|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
62755|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
62756|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
62757|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
62758|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
62759|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
62760|NCT01996709|O4|Outcome|Habitual MPS, Left Eye|Habitual contact lens solution used with habitual contact lenses for 90 days
62761|NCT01996709|O3|Outcome|Habitual MPS, Right Eye|Habitual contact lens solution used with habitual contact lenses for 90 days
62762|NCT01996709|O2|Outcome|Clear Care, Left Eye|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
62763|NCT01996709|O1|Outcome|Clear Care, Right Eye|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
62764|NCT01996709|E2|Reported Event|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
62765|NCT01996709|E1|Reported Event|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
62766|NCT01996657|B4|Baseline|Total|Total of all reporting groups
62767|NCT01996657|B3|Baseline|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin"
62768|NCT01996657|B2|Baseline|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin"
62769|NCT01996657|B1|Baseline|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin"
62770|NCT01996657|P3|Participant Flow|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin"
62771|NCT01996657|P2|Participant Flow|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin"
62772|NCT01996657|P1|Participant Flow|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin"
62773|NCT01996657|O3|Outcome|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin"
62774|NCT01996657|O2|Outcome|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin"
62775|NCT01996657|O1|Outcome|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin"
62776|NCT01996657|O3|Outcome|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin"
62777|NCT01996657|O2|Outcome|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin"
62778|NCT01996657|O1|Outcome|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin"
62779|NCT01996657|O3|Outcome|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin"
62780|NCT01996657|O2|Outcome|Low Intensity and Adjusted by Elevated D-dimer|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin"
62781|NCT01996657|O1|Outcome|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin"
62782|NCT01996657|E3|Reported Event|Low Intensity Without Adjustment|"The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin"
62783|NCT01996657|E2|Reported Event|D-dimer-guided Adjustmentd of Anticoagutlation Intensity|"The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin"
62784|NCT01996657|E1|Reported Event|Standard Intensity of Anticoagulation|"After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin"
62785|NCT01996410|B9|Baseline|Total|Total of all reporting groups
62786|NCT01996410|B8|Baseline|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62787|NCT01996410|B7|Baseline|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62788|NCT01996410|B6|Baseline|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62789|NCT01996410|B5|Baseline|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62790|NCT01996410|B4|Baseline|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62791|NCT01996410|B3|Baseline|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62792|NCT01996410|B2|Baseline|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62793|NCT01996410|B1|Baseline|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62794|NCT01996410|P8|Participant Flow|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62795|NCT01996410|P7|Participant Flow|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62796|NCT01996410|P6|Participant Flow|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62797|NCT01996410|P5|Participant Flow|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62798|NCT01996410|P4|Participant Flow|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62799|NCT01996410|P3|Participant Flow|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62800|NCT01996410|P2|Participant Flow|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62801|NCT01996410|P1|Participant Flow|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62802|NCT01996410|O2|Outcome|Standard of Care- No Acupuncture|
62803|NCT01996410|O1|Outcome|Acupuncture|
62804|NCT01996410|E8|Reported Event|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62805|NCT01996410|E7|Reported Event|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62806|NCT01996410|E6|Reported Event|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62807|NCT01996410|E5|Reported Event|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62886|NCT01995045|E1|Reported Event|Bupivicaine & Triamcinolone|"Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide
Triamcinolone: Retrobulbar anesthesia
Bupivicaine Hydrochloride: Retrobulbar anesthesia"
62887|NCT01994902|B1|Baseline|Overall Study|The investigation is a cross-over investigation therefore the baseline data is given for the overall study population
62893|NCT01994902|E1|Reported Event|Coloplast Test Product|Adverse events reported by subjects testing Coloplast test product
62894|NCT01994876|B1|Baseline|Overall Study|All the subjects in one group
62924|NCT01994785|E3|Reported Event|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62808|NCT01996410|E4|Reported Event|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62809|NCT01996410|E3|Reported Event|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62810|NCT01996410|E2|Reported Event|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62811|NCT01996410|E1|Reported Event|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.
Acupuncture
No Acupuncture- Standard of Care"
62812|NCT01996332|B1|Baseline|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
62813|NCT01996332|P1|Participant Flow|Erlotinib 150 Milligrams Per Day (mg/Day)|Participants received erlotinib 150 milligrams/day (mg/day), orally, until progressive disease or unacceptable toxicity.
62814|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
62815|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
62816|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
62817|NCT01996332|E1|Reported Event|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
62818|NCT01996319|B3|Baseline|Total|Total of all reporting groups
62819|NCT01996319|B2|Baseline|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
62820|NCT01996319|B1|Baseline|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
62821|NCT01996319|P2|Participant Flow|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
62822|NCT01996319|P1|Participant Flow|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
62823|NCT01996319|O2|Outcome|Placebo|
62824|NCT01996319|O1|Outcome|QVA149|
62825|NCT01996319|O2|Outcome|Placebo|
62826|NCT01996319|O1|Outcome|QVA149|
62827|NCT01996319|O2|Outcome|Placebo|
62828|NCT01996319|O1|Outcome|QVA149|
62829|NCT01996319|O2|Outcome|Placebo|
62830|NCT01996319|O1|Outcome|QVA149|
62831|NCT01996319|O2|Outcome|Placebo|
62832|NCT01996319|O1|Outcome|QVA149|
62833|NCT01996319|O2|Outcome|Placebo|
62834|NCT01996319|O1|Outcome|QVA149|
62835|NCT01996319|O2|Outcome|Placebo|
62836|NCT01996319|O1|Outcome|QVA149|
62837|NCT01996319|O2|Outcome|Placebo|
62838|NCT01996319|O1|Outcome|QVA149|
62839|NCT01996319|E2|Reported Event|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
62840|NCT01996319|E1|Reported Event|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
62841|NCT01995461|B1|Baseline|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)
bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
62842|NCT01995461|P1|Participant Flow|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)
bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
62888|NCT01994902|P2|Participant Flow|First SenSura Convex Light; Then Coloplast Test Product|"The subjects test:
test period 1: SenSura Convex Light test period 2: Coloplast test product"
62843|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)
bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
62844|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)
bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
62845|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)
bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
62846|NCT01995461|E1|Reported Event|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)
bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
62847|NCT01995357|B1|Baseline|All Subjects|Baseline data is summarized for all subjects
62848|NCT01995357|P6|Participant Flow|First Standard Product, Then Coloplast Test B|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
62849|NCT01995357|P5|Participant Flow|First Standard Product; Then Coloplast Test A|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
62850|NCT01995357|P4|Participant Flow|First Coloplast Test B; Then Standard Product|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
62851|NCT01995357|P3|Participant Flow|First Coloplast Test B; Then Colopast Test A|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
62852|NCT01995357|P2|Participant Flow|First Coloplast Test A; Then Standard Product|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
62889|NCT01994902|P1|Participant Flow|First Coloplast Test Product; Then SenSura Convex Light|"The subjects test:
test period 1: Coloplast test product test period 2: SenSura Convex Light"
62890|NCT01994902|O2|Outcome|SenSura Convex Light|The leakage results obtained while subjects were testing SenSura Convex Light
62891|NCT01994902|O1|Outcome|Coloplast Test Product|Leakage results obtained while subjects tested the Coloplast test product
62892|NCT01994902|E2|Reported Event|SenSura Convex Light|Adverse events reported by subjects testing SenSura Convex Light
62975|NCT01994720|E2|Reported Event|Ticagrelor 90mg|Ticagrelor 90 mg twice daily (BD)
62853|NCT01995357|P1|Participant Flow|First Coloplast Teast A; Then Coloplast Test B|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
62854|NCT01995357|O11|Outcome|Ileostomy, Standard Care (SenSura)|
62855|NCT01995357|O10|Outcome|Ileostomy, Training + Test B|
62856|NCT01995357|O9|Outcome|Ileostomy, Test B|
62857|NCT01995357|O8|Outcome|Ileostomy, Training + Test A|
62858|NCT01995357|O7|Outcome|Ileostomy, Test A|
62859|NCT01995357|O6|Outcome|Colostomy, Standard Care (SenSura)|
62860|NCT01995357|O5|Outcome|Colostomy, Standard Care (SenSura Mio)|
62861|NCT01995357|O4|Outcome|Colostomy, Training + Test B|
62862|NCT01995357|O3|Outcome|Colostomy, Test B|
62863|NCT01995357|O2|Outcome|Colostomy, Training + Test A|
62864|NCT01995357|O1|Outcome|Colostomy ,Test A|
62865|NCT01995357|E3|Reported Event|Standard Care|Standard care was used only during part one of the study. i.e. for one period only.
62866|NCT01995357|E2|Reported Event|Test B + Training Test B|"Test Product B was used both during part one of the study (Test B) and part two (Training Test B) hence adverse events are reported collectively for Test Product B.
Consequently, Test Product B is used for two periods compared to Standard care which has been used for only one."
62867|NCT01995357|E1|Reported Event|Test A + Training Test A|"Test Product A was used both during part one of the study (Test A) and part two (Training Test A) hence adverse events are reported collectively for Test Product A.
Consequently, Test Product A is used for two periods compared to Standard care which has been used for only one."
62868|NCT01995136|B1|Baseline|TRAVATAN Z|Ophthalmic solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
62869|NCT01995136|P1|Participant Flow|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
62870|NCT01995136|O1|Outcome|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
62871|NCT01995136|E1|Reported Event|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
62872|NCT01995045|B3|Baseline|Total|Total of all reporting groups
62873|NCT01995045|B2|Baseline|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
62874|NCT01995045|B1|Baseline|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
62875|NCT01995045|P2|Participant Flow|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
62876|NCT01995045|P1|Participant Flow|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
62877|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
62878|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
62879|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
62880|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
62881|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
62882|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
62883|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
62884|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
62885|NCT01995045|E2|Reported Event|Bupivicaine|"Retrobulbar anesthesia with Bupivicaine Hydrochloride
Bupivicaine Hydrochloride: Retrobulbar anesthesia"
62895|NCT01994876|P2|Participant Flow|First Coloplast Test 2, Then Coloplast Test 1|"The subjects first test their own product to collect baseline measurements
The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1
Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance"
62896|NCT01994876|P1|Participant Flow|First Coloplast Test 1, Then Coloplast Test 2|"The subjects first test their own product to collect a baseline measurement
The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2
Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance"
62897|NCT01994876|O3|Outcome|Basline - Own Product|Data from subject testing own product. Measures baseline leakage
62898|NCT01994876|O2|Outcome|Coloplast Test 2|Results from subjects testing Coloplast Test 2
62899|NCT01994876|O1|Outcome|Coloplast Test 1|Results from subjects testing Coloplast Test 1
62900|NCT01994876|E3|Reported Event|Basline - Own Product|Data from subject testing own product. Measures baseline leakage
62901|NCT01994876|E2|Reported Event|Coloplast Test 2|Results from subjects testing Coloplast Test 2
62902|NCT01994876|E1|Reported Event|Coloplast Test 1|Results from subjects testing Coloplast Test 1
62903|NCT01994863|B1|Baseline|All Subjects|
62904|NCT01994863|P2|Participant Flow|First Standard Care (See Below); Then Coloplast Test Product|"The subjects are randomised to test Standard care first and thereafter test Coloplast test product.
Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.
The three Standard Care products were tested in a 1:1:1 randomisation.
Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance
Standard Care: Standard care consists of three already marketed 1-piece ostomy products
Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"
62905|NCT01994863|P1|Participant Flow|First Coloplast Test Product; Then Standard Care (See Below)|"The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care.
Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.
The three Standard Care products were tested in a 1:1:1 randomisation.
Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance
Standard Care: Standard care consists of three already marketed 1-piece ostomy products
Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"
62906|NCT01994863|O2|Outcome|Standard Care|
62907|NCT01994863|O1|Outcome|Coloplast Test Product|
62908|NCT01994863|E2|Reported Event|Standard Care|
62909|NCT01994863|E1|Reported Event|Coloplast Test Product|
62910|NCT01994785|B5|Baseline|Total|Total of all reporting groups
62911|NCT01994785|B4|Baseline|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62912|NCT01994785|B3|Baseline|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62913|NCT01994785|B2|Baseline|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62914|NCT01994785|B1|Baseline|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62915|NCT01994785|P4|Participant Flow|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62916|NCT01994785|P3|Participant Flow|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62917|NCT01994785|P2|Participant Flow|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62918|NCT01994785|P1|Participant Flow|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62919|NCT01994785|O4|Outcome|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62920|NCT01994785|O3|Outcome|Colonoscopy Capnography Open|"Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62921|NCT01994785|O2|Outcome|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62922|NCT01994785|O1|Outcome|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62923|NCT01994785|E4|Reported Event|Colonoscopy Capnography Blinded|"Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62980|NCT01994629|P2|Participant Flow|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-tetanus toxoid (TT) vaccine.
62925|NCT01994785|E2|Reported Event|EGD Capnography Blinded|"Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62926|NCT01994785|E1|Reported Event|EGD Capnography Open|"Capnographic monitoring during EGD - Data made available to study staff throughout procedure
Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring"
62927|NCT01994746|B1|Baseline|All Study Participants|"At one visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
At another visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.
The order of the visits was randomized."
62928|NCT01994746|P2|Participant Flow|Intramuscular Glucagon 1st/Intranasal Glucagon 2nd|"At the first visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.
At the second visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
62929|NCT01994746|P1|Participant Flow|Intranasal Glucagon 1st/Intramuscular Glucagon 2nd|"At the first visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
At the second visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm."
62930|NCT01994746|O2|Outcome|Intramuscular Glucagon|"At a separate visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.
Intramuscular Glucagon"
62931|NCT01994746|O1|Outcome|Intranasal Glucagon|"At one visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
Intranasal Glucagon"
62932|NCT01994746|E2|Reported Event|Intramuscular Glucagon|1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.
62933|NCT01994746|E1|Reported Event|Intranasal Glucagon|A glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
62934|NCT01994720|B3|Baseline|Total|Total of all reporting groups
62935|NCT01994720|B2|Baseline|ASA 100 mg|ASA 100 mg once daily (OD)
62936|NCT01994720|B1|Baseline|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62937|NCT01994720|P2|Participant Flow|ASA 100 mg|ASA 100 mg once daily (OD)
62938|NCT01994720|P1|Participant Flow|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62939|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62940|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62941|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62942|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62943|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62944|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62945|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62946|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62947|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62948|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62949|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62950|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62951|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62952|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62953|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62954|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62955|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62956|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62957|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62958|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62959|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62960|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62961|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62962|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62963|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62964|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62965|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62966|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62967|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62968|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62969|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62970|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62971|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
62972|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
62978|NCT01994629|B2|Baseline|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
62979|NCT01994629|B1|Baseline|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
62981|NCT01994629|P1|Participant Flow|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-cross reactive material (CRM) vaccine.
62982|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
62983|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
62984|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
62985|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
62986|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
62987|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
62988|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
62989|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
62990|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
62991|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
62992|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
62993|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
62994|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
62995|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
62996|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
62997|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
62998|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
62999|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
63000|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
63001|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
63002|NCT01994629|E2|Reported Event|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
63003|NCT01994629|E1|Reported Event|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
63004|NCT01994486|B1|Baseline|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.
Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
63005|NCT01994486|P1|Participant Flow|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.
In addition, sparse PK samples will be collected at week 2 and week 10."
63006|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
63007|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.
In addition, sparse PK samples will be collected at week 2 and week 10."
63008|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.
Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
63009|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.
Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
63010|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.
Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
63011|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
63012|NCT01994486|E1|Reported Event|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
63013|NCT01994291|B4|Baseline|Total|Total of all reporting groups
63014|NCT01994291|B3|Baseline|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63015|NCT01994291|B2|Baseline|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63016|NCT01994291|B1|Baseline|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63017|NCT01994291|P3|Participant Flow|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63018|NCT01994291|P2|Participant Flow|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63019|NCT01994291|P1|Participant Flow|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63020|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63021|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63022|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63023|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63024|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63025|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63026|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63027|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63028|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63029|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63030|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63031|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63032|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63033|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63034|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63035|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63036|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63037|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63038|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63039|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63040|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63041|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63042|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63043|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63044|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63045|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63046|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63047|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63048|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63049|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63050|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63051|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63052|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63053|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63054|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63055|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63056|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63057|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63058|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63059|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63060|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63061|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63062|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63063|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63064|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63065|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
63066|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63067|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63068|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63069|NCT01994291|E3|Reported Event|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
63070|NCT01994291|E2|Reported Event|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
63071|NCT01994291|E1|Reported Event|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
63072|NCT01993940|B3|Baseline|Total|Total of all reporting groups
63073|NCT01993940|B2|Baseline|Placebo|Participants received placebo orally once daily for 12 weeks.
63074|NCT01993940|B1|Baseline|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
63075|NCT01993940|P2|Participant Flow|Placebo|Participants received placebo orally once daily for 12 weeks.
63076|NCT01993940|P1|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
63077|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
63078|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
63079|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
63080|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
63081|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
63082|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
63083|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
63084|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
63085|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
63086|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
63087|NCT01993940|E2|Reported Event|Placebo|Participants received placebo orally once daily for 12 weeks.
63088|NCT01993940|E1|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
63089|NCT01993888|B3|Baseline|Total|Total of all reporting groups
63090|NCT01993888|B2|Baseline|Standard of Care (SoC)|"SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
Standard of Care (SoC)"
63091|NCT01993888|B1|Baseline|EVARREST Fibrin Sealant Patch|"EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
EVARREST™ Fibrin Sealant Patch"
63092|NCT01993888|P2|Participant Flow|Standard of Care (SoC)|"SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
Standard of Care (SoC)"
63093|NCT01993888|P1|Participant Flow|EVARREST Fibrin Sealant Patch|"EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
EVARREST™ Fibrin Sealant Patch"
63094|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
63095|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
63096|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
63097|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
63098|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
63099|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
63126|NCT01993030|B1|Baseline|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
HQ® Matrix Medical Wound Dressing"
63624|NCT01991314|E1|Reported Event|Adolescents|Patients aged 13 - 18 years
63100|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
63674|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select RNFL variables
63101|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
63102|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
63103|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
63104|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
63105|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
63106|NCT01993888|E2|Reported Event|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
63107|NCT01993888|E1|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
63108|NCT01993823|B3|Baseline|Total|Total of all reporting groups
63109|NCT01993823|B2|Baseline|Clotrimazole|"Five drops into the ear canal twice daily for 14 days
Clotrimazole: Five drops into the ear canal twice daily for 14 days"
63110|NCT01993823|B1|Baseline|G238|"Five drops into the ear canal twice daily for 14 days
G238: Five drops into the ear canal twice daily for 14 days"
63111|NCT01993823|P2|Participant Flow|Clotrimazole|"Five drops into the ear canal twice daily for 14 days
Clotrimazole: Five drops into the ear canal twice daily for 14 days"
63112|NCT01993823|P1|Participant Flow|G238|"Five drops into the ear canal twice daily for 14 days
G238: Five drops into the ear canal twice daily for 14 days"
63113|NCT01993823|O2|Outcome|Clotrimazole|"Five drops into the ear canal twice daily for 14 days
Clotrimazole: Five drops into the ear canal twice daily for 14 days"
63114|NCT01993823|O1|Outcome|G238|"Five drops into the ear canal twice daily for 14 days
G238: Five drops into the ear canal twice daily for 14 days"
63115|NCT01993823|O2|Outcome|Clotrimazole|"Five drops into the ear canal twice daily for 14 days
Clotrimazole: Five drops into the ear canal twice daily for 14 days"
63116|NCT01993823|O1|Outcome|G238|"Five drops into the ear canal twice daily for 14 days
G238: Five drops into the ear canal twice daily for 14 days"
63117|NCT01993823|E2|Reported Event|Clotrimazole|"Five drops into the ear canal twice daily for 14 days
Clotrimazole: Five drops into the ear canal twice daily for 14 days"
63118|NCT01993823|E1|Reported Event|G238|"Five drops into the ear canal twice daily for 14 days
G238: Five drops into the ear canal twice daily for 14 days"
63119|NCT01993238|B1|Baseline|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).
Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
63120|NCT01993238|P1|Participant Flow|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).
Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
63121|NCT01993238|O1|Outcome|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).
Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
63122|NCT01993238|O1|Outcome|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).
Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
63123|NCT01993238|E1|Reported Event|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).
Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
63124|NCT01993030|B3|Baseline|Total|Total of all reporting groups
63125|NCT01993030|B2|Baseline|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
Sidaiyi® wound dressing"
63540|NCT01992094|O1|Outcome|QIVc (18 to <65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63127|NCT01993030|P2|Participant Flow|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
Sidaiyi® wound dressing"
63128|NCT01993030|P1|Participant Flow|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
HQ® Matrix Medical Wound Dressing"
63129|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
Sidaiyi® wound dressing"
63130|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
HQ® Matrix Medical Wound Dressing"
63131|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
Sidaiyi® wound dressing"
63132|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
HQ® Matrix Medical Wound Dressing"
63133|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
Sidaiyi® wound dressing"
63134|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
HQ® Matrix Medical Wound Dressing"
63135|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
Sidaiyi® wound dressing"
63136|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
HQ® Matrix Medical Wound Dressing"
63137|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
Sidaiyi® wound dressing"
63138|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
HQ® Matrix Medical Wound Dressing"
63139|NCT01993030|E2|Reported Event|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
Sidaiyi® wound dressing"
63140|NCT01993030|E1|Reported Event|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed
HQ® Matrix Medical Wound Dressing"
63141|NCT01992874|B1|Baseline|Entire Study Population|It included all the subjects randomized to receive either Pimasertib 60 mg capsule and Pimasertib 60 mg tablet first in Part A and Pimasertib 60 mg capsule in Part B of the study.
63142|NCT01992874|P3|Participant Flow|Part B:Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
63143|NCT01992874|P2|Participant Flow|Part A: Pimasertib Tablet Then Pimasertib Capsule|A single dose of 3 Pimasertib 20 mg tablet administered orally on Day 1 in first intervention period followed by a single dose of 2 Pimasertib 30 mg capsule single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
63144|NCT01992874|P1|Participant Flow|Part A: Pimasertib Capsule Then Pimasertib Tablet|A single dose of 2 Pimasertib 30 mg capsule administered orally on Day 1 in first intervention period followed by a single dose of 3 Pimasertib 20 mg tablet single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
63145|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
63146|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
63147|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
63148|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
63149|NCT01992874|O3|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
63150|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
63151|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
63152|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
63153|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
63154|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
63155|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
63156|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
63157|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
63158|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
63617|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
63159|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
63160|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
89807|NCT01843374|E1|Reported Event|PLACEBO|Placebo.
63161|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
63162|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
63163|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
63164|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
63165|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study
63166|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
63167|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
63168|NCT01992874|E3|Reported Event|Part B: Pimasertib Capsule (BID)|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
63169|NCT01992874|E2|Reported Event|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
63170|NCT01992874|E1|Reported Event|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
63171|NCT01992536|B11|Baseline|Total|Total of all reporting groups
63172|NCT01992536|B10|Baseline|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63173|NCT01992536|B9|Baseline|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63174|NCT01992536|B8|Baseline|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63175|NCT01992536|B7|Baseline|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
63176|NCT01992536|B6|Baseline|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63177|NCT01992536|B5|Baseline|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63178|NCT01992536|B4|Baseline|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63179|NCT01992536|B3|Baseline|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63180|NCT01992536|B2|Baseline|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63181|NCT01992536|B1|Baseline|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63182|NCT01992536|P10|Participant Flow|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63183|NCT01992536|P9|Participant Flow|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63184|NCT01992536|P8|Participant Flow|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63185|NCT01992536|P7|Participant Flow|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
63186|NCT01992536|P6|Participant Flow|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63187|NCT01992536|P5|Participant Flow|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63188|NCT01992536|P4|Participant Flow|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63189|NCT01992536|P3|Participant Flow|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63190|NCT01992536|P2|Participant Flow|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63191|NCT01992536|P1|Participant Flow|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63192|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63193|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63194|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63195|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
63196|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
63197|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
63198|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
63199|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63200|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63201|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63202|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63203|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63204|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63205|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
63206|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
63207|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
63208|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
63209|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63210|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63211|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63212|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63213|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63214|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63215|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
63216|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
63217|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
63218|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
63219|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63220|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63221|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63222|NCT01992536|O11|Outcome|Total|
63223|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63224|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63225|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63226|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
63227|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63228|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63229|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63230|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63231|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63232|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63233|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63234|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63235|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63236|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
63237|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
63238|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
63239|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63240|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63241|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63242|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63243|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63244|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63245|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63246|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63247|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63248|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63249|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63250|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63251|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63252|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63253|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63254|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
63255|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
63256|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
63257|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63258|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63259|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63260|NCT01992536|O6|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63261|NCT01992536|O5|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63262|NCT01992536|O4|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
63263|NCT01992536|O3|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
63264|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63265|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63266|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63267|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63268|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63269|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63270|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63271|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63272|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63273|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63274|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63275|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63276|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63277|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63278|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
63279|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
63280|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
63281|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63282|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63283|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63284|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63285|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63286|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63287|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63288|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63289|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63290|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63291|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63292|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63293|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63294|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63295|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63296|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63297|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63298|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63299|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63300|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63301|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63302|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63303|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63304|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63305|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63306|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63307|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63308|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63309|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63310|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63311|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63312|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63313|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63314|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
63315|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
63316|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
63317|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63318|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63319|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63320|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63321|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63322|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63323|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63324|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63325|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63326|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63327|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63328|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63329|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63330|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63331|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63332|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63333|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63334|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63335|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63336|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63337|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63338|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63339|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63340|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63341|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63342|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63343|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63344|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63345|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63346|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63347|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63348|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63349|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63350|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63351|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63352|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63353|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63354|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63355|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63356|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63357|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63358|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63359|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63360|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
63361|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
63362|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63363|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63364|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63365|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63366|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
63367|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63368|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
63369|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
63370|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
63371|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63372|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63373|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63374|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
63375|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
63376|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
63377|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
63378|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
63379|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
63380|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
63381|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
63382|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
63383|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
63384|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
63385|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
63386|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
63387|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
63388|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
63389|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
63390|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63391|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63392|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63393|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63394|NCT01992536|E11|Reported Event|Total|Total
63395|NCT01992536|E10|Reported Event|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
63396|NCT01992536|E9|Reported Event|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63397|NCT01992536|E8|Reported Event|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
63398|NCT01992536|E7|Reported Event|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
63399|NCT01992536|E6|Reported Event|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
63400|NCT01992536|E5|Reported Event|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
63401|NCT01992536|E4|Reported Event|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
63402|NCT01992536|E3|Reported Event|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
63618|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
63403|NCT01992536|E2|Reported Event|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
63675|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select RNFL variables
63404|NCT01992536|E1|Reported Event|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
63405|NCT01992523|B3|Baseline|Total|Total of all reporting groups
63406|NCT01992523|B2|Baseline|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills
Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
63407|NCT01992523|B1|Baseline|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills
Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
63408|NCT01992523|P2|Participant Flow|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills
Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
63409|NCT01992523|P1|Participant Flow|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills
Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
63410|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills
Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
63411|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills
Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
63412|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills
Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
63413|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills
Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
63414|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills
Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
63415|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills
Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
63416|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|
63417|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|
63418|NCT01992523|E2|Reported Event|Ticagrelor Integral Group|patients taking orally 180 mg ticagrelor integral tablets
63419|NCT01992523|E1|Reported Event|Ticagrelor Mashed Group|patients taking orally 180 mg ticagrelor mashed tablets
63420|NCT01992185|B3|Baseline|Total|Total of all reporting groups
63421|NCT01992185|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
63422|NCT01992185|B1|Baseline|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo
Photocil for Vitiligo: Photocil for Vitiligo"
63423|NCT01992185|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
63424|NCT01992185|P1|Participant Flow|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo
Photocil for Vitiligo: Photocil for Vitiligo"
90858|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
63425|NCT01992185|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
63426|NCT01992185|O1|Outcome|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo
Photocil for Vitiligo: Photocil for Vitiligo"
63427|NCT01992185|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
63428|NCT01992185|E1|Reported Event|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo
Photocil for Vitiligo: Photocil for Vitiligo"
63429|NCT01992172|B3|Baseline|Total|Total of all reporting groups
63430|NCT01992172|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
63431|NCT01992172|B1|Baseline|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis
Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
63432|NCT01992172|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
63433|NCT01992172|P1|Participant Flow|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis
Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
63434|NCT01992172|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
63435|NCT01992172|O1|Outcome|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis
Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
63436|NCT01992172|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
63437|NCT01992172|E1|Reported Event|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis
Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
63438|NCT01992107|B4|Baseline|Total|Total of all reporting groups
63439|NCT01992107|B3|Baseline|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63440|NCT01992107|B2|Baseline|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63441|NCT01992107|B1|Baseline|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63442|NCT01992107|P3|Participant Flow|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63443|NCT01992107|P2|Participant Flow|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63444|NCT01992107|P1|Participant Flow|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63445|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63446|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63447|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63448|NCT01992107|O15|Outcome|TIV2c (≥9 to <18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63449|NCT01992107|O14|Outcome|TIV1c (≥9 to <18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63450|NCT01992107|O13|Outcome|QIVc (≥9 to <18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63451|NCT01992107|O12|Outcome|TIV2c _Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63452|NCT01992107|O11|Outcome|TIV1c_Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63453|NCT01992107|O10|Outcome|QIVc _Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63454|NCT01992107|O9|Outcome|TIV2c _First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63455|NCT01992107|O8|Outcome|TIV1c_First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2,B1) recommended for 2013-2014 season
63456|NCT01992107|O7|Outcome|QIVc _First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63457|NCT01992107|O6|Outcome|TIV2c _Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63458|NCT01992107|O5|Outcome|TIV1c_Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63459|NCT01992107|O4|Outcome|QIVc _Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63460|NCT01992107|O3|Outcome|TIV2c _First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63461|NCT01992107|O2|Outcome|TIV1c_First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63462|NCT01992107|O1|Outcome|QIVc _First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63629|NCT01990859|B1|Baseline|Ipilimumab|Participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses.
63463|NCT01992107|O2|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63464|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63465|NCT01992107|O2|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63466|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63467|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63468|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63469|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63470|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63471|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63472|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63473|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63474|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63475|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63476|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63477|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63478|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63479|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63480|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63481|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63482|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63483|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63484|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63485|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63486|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63487|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63488|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63489|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63490|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63491|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63492|NCT01992107|E4|Reported Event|Total|Total number of Subjects
63493|NCT01992107|E3|Reported Event|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63494|NCT01992107|E2|Reported Event|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63495|NCT01992107|E1|Reported Event|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
63496|NCT01992094|B4|Baseline|Total|Total of all reporting groups
63497|NCT01992094|B3|Baseline|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63498|NCT01992094|B2|Baseline|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
63499|NCT01992094|B1|Baseline|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63500|NCT01992094|P3|Participant Flow|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63501|NCT01992094|P2|Participant Flow|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
63502|NCT01992094|P1|Participant Flow|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63503|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63504|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63505|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63506|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63507|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63508|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63509|NCT01992094|O2|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63510|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63511|NCT01992094|O2|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63512|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63513|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63514|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63515|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63516|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63517|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63518|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63519|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
63520|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
63521|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63522|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63523|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63524|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63525|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
63526|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
63527|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63528|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63529|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63530|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63531|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
63532|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
63533|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63534|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63535|NCT01992094|O6|Outcome|TIV2c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63536|NCT01992094|O5|Outcome|TIV2c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63537|NCT01992094|O4|Outcome|TIV1c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
63538|NCT01992094|O3|Outcome|TIV1c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
63539|NCT01992094|O2|Outcome|QIVc (≥ 65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63541|NCT01992094|O6|Outcome|TIV2c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63542|NCT01992094|O5|Outcome|TIV2c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63543|NCT01992094|O4|Outcome|TIV1c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
63544|NCT01992094|O3|Outcome|TIV1c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013- 2014 season
63545|NCT01992094|O2|Outcome|QIVc (≥ 65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63546|NCT01992094|O1|Outcome|QIVc (18 to <65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63547|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63548|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63549|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63550|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63551|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63552|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63553|NCT01992094|E4|Reported Event|Total|Total Number of Subjects
63554|NCT01992094|E3|Reported Event|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
63555|NCT01992094|E2|Reported Event|TIV1c (≥ 18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
63556|NCT01992094|E1|Reported Event|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
63557|NCT01991990|B3|Baseline|Total|Total of all reporting groups
63558|NCT01991990|B2|Baseline|Tocilizumab|Participants received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0.
63559|NCT01991990|B1|Baseline|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63560|NCT01991990|P2|Participant Flow|Tocilizumab|Participants received a single dose of intravenous (IV) tocilizumab (TCZ) at a dose of 8 milligrams (mg) per kilogram (kg) body weight infusion over 1 hour on Day 0.
63561|NCT01991990|P1|Participant Flow|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63562|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63563|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63564|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63565|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63566|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63567|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63568|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63569|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63570|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63571|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63572|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63573|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63574|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63575|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63576|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63577|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63619|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
63578|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63579|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63580|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63581|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63582|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63583|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63584|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63585|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63586|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63587|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63588|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63589|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63590|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63591|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63592|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63593|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63594|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63595|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with greater than (>) 50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63596|NCT01991990|O2|Outcome|Tocilizumab (Polymorphonuclear Leukocyte (PMN)]-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with less than or equal to (≤) 50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
63597|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63598|NCT01991990|E2|Reported Event|Tocilizumab|Participants received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0.
63599|NCT01991990|E1|Reported Event|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
63600|NCT01991548|B1|Baseline|Insulin Dependent Diabetics|individuals with insulin dependant diabetes using the 640G insulin pump for insulin infusion and continuous glucose monitoring
63601|NCT01991548|P1|Participant Flow|Insulin Dependent Diabetics|Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 640G insulin pump and Guardian Link transmitter.
63602|NCT01991548|O1|Outcome|Overall|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
63603|NCT01991548|E1|Reported Event|Overall|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
63604|NCT01991314|B3|Baseline|Total|Total of all reporting groups
63605|NCT01991314|B2|Baseline|Adults - Ferrous Sulphate|43 adults (age >18 years) given oral ferrous sulphate 200mg bd for 6 weeks
63606|NCT01991314|B1|Baseline|Adolescent - Ferrous Sulphate|45 adolescents (age 13-18 years) given oral ferrous sulphate 200mg bd for 6 weeks
63607|NCT01991314|P2|Participant Flow|Adults - Ferrous Sulphate|43 adults (>18 years) given ferrous sulphate 200mg bd for 6 weeks
63608|NCT01991314|P1|Participant Flow|Adolescents - Ferrous Sulphate|45 adolescents (13-18 years) given ferrous sulphate 200mg bd for 6 weeks
63609|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
63610|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
63611|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
63612|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
63613|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
63614|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
63615|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
63616|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
63630|NCT01990859|P1|Participant Flow|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
63631|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
63632|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
63633|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
63634|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
63635|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
63636|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
63637|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
63638|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
63639|NCT01990859|E1|Reported Event|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
63640|NCT01990794|B1|Baseline|Study Volunteers|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
63641|NCT01990794|P1|Participant Flow|Study Volunteers|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
63642|NCT01990794|O4|Outcome|1 mo Postdose|Values of the sural sensory and peroneal motor variables
63643|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
63644|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
63645|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
63646|NCT01990794|O4|Outcome|1 mo Postdose|Values of the sural sensory and peroneal motor variables
63647|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
63648|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
63649|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
63650|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select VFI variables
63651|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select VFI variables
63652|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select VFI variables
63653|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select VFI variables
63654|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select VFI variables
63655|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select VFI variables
90859|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
63676|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select RNFL variables
63677|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select RNFL variables
63678|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select RNFL variables
63679|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select RNFL variables
63680|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
63681|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
63682|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
63683|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
63684|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
63685|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
63686|NCT01990794|O2|Outcome|Male Cobalt Serum Concentrations|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
63687|NCT01990794|O1|Outcome|Female Cobalt Serum Concentrations|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
63688|NCT01990794|O2|Outcome|Male Cobalt Urine Concentrations|Cobalt urine concentrations after cessation of cobalt supplementation
63689|NCT01990794|O1|Outcome|Female Cobalt Urine Concentrations|Cobalt urine concentrations after cessation of cobalt supplementation
63690|NCT01990794|O2|Outcome|Male Cobalt Urine Concentrations|Cobalt urine concentrations during daily oral intake of 1 mg Co.
63691|NCT01990794|O1|Outcome|Female Cobalt Urine Concentrations|Cobalt urine concentrations during daily oral intake of 1 mg Co.
63692|NCT01990794|O2|Outcome|Male Glucose|Glucose levels before, during, and after dosing
63693|NCT01990794|O1|Outcome|Female Glucose|Glucose levels before, during and after dosing
63694|NCT01990794|O2|Outcome|Male Triglycerides|Triglyceride levels before and after cobalt supplementation
63695|NCT01990794|O1|Outcome|Female Triglycerides|Triglyceride levels before and after cobalt supplementation
63696|NCT01990794|O2|Outcome|Male Total Cholesterol|Total cholesterol levels before and after cobalt supplementation
63697|NCT01990794|O1|Outcome|Female Total Cholesterol|Total cholesterol levels before and after cobalt supplementation
63698|NCT01990794|O2|Outcome|Male HDL Cholesterol|HDL cholesterol levels before and after cobalt supplementation
63699|NCT01990794|O1|Outcome|Female HDL Cholesterol|HDL cholesterol levels before and after cobalt supplementation
63700|NCT01990794|O2|Outcome|Male AST|AST levels before, during, and after dosing
63701|NCT01990794|O1|Outcome|Female AST|AST levels before, during and after dosing
63702|NCT01990794|O2|Outcome|Male ALT|ALT levels before, during, and after dosing
63703|NCT01990794|O1|Outcome|Female ALT|ALT levels before, during and after dosing
63704|NCT01990794|O2|Outcome|Male Creatine|Creatine levels before, during, and after dosing
63705|NCT01990794|O1|Outcome|Female Creatine|Creatine levels before, during and after dosing
63706|NCT01990794|O2|Outcome|Male CK-MB|CK-MB levels before, during, and after dosing
63707|NCT01990794|O1|Outcome|Female CK-MB|CK-MB levels before, during and after dosing
63708|NCT01990794|O2|Outcome|Male Ferritin|Ferritin levels before, during, and after dosing
63709|NCT01990794|O1|Outcome|Female Ferritin|Ferritin levels before, during and after dosing
63710|NCT01990794|O2|Outcome|Male Total Iron|Total iron levels before, during, and after dosing
63711|NCT01990794|O1|Outcome|Female Total Iron|Total iron levels before, during and after dosing
63712|NCT01990794|O2|Outcome|Male T4|T4 levels before, during, and after dosing
63713|NCT01990794|O1|Outcome|Female T4|T4 levels before, during and after dosing
63714|NCT01990794|O2|Outcome|Male TSH|TSH levels before, during, and after dosing
63715|NCT01990794|O1|Outcome|Female TSH|TSH levels before, during and after dosing
63716|NCT01990794|O2|Outcome|Male Albumin|Albumin levels before, during, and after dosing
63717|NCT01990794|O1|Outcome|Female Albumin|Albumin levels before, during and after dosing
63718|NCT01990794|O2|Outcome|Male Protein|Protein levels before, during, and after dosing
63719|NCT01990794|O1|Outcome|Female Protein|Protein levels before, during and after dosing
63720|NCT01990794|O2|Outcome|Male Hematocrit|Hematocrit levels before, during, and after dosing
63721|NCT01990794|O1|Outcome|Female Hematocrit|Hematocrit levels before, during and after dosing
63722|NCT01990794|O2|Outcome|Male RBC|RBC levels before, during, and after dosing
63723|NCT01990794|O1|Outcome|Female RBC|RBC levels before, during and after dosing
63724|NCT01990794|O2|Outcome|Male WBC|WBC levels before, during, and after dosing
63725|NCT01990794|O1|Outcome|Female WBC|WBC levels before, during and after dosing
63726|NCT01990794|O2|Outcome|Male|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
63727|NCT01990794|O1|Outcome|Female|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
63728|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
63729|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
63730|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
63731|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select ONH variables
63732|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select ONH variables
63733|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select ONH variables
63734|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select ONH variables
63735|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select ONH variables
63736|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select ONH variables
63737|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
63738|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
63739|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
63740|NCT01990794|O6|Outcome|Study Completion - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
63741|NCT01990794|O5|Outcome|Study Completion - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
63742|NCT01990794|O4|Outcome|Study Midpoint - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
63743|NCT01990794|O3|Outcome|Study Midpoint - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
63744|NCT01990794|O2|Outcome|Baseline - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
63745|NCT01990794|O1|Outcome|Baseline - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
63746|NCT01990794|O2|Outcome|Male Hgb|Hgb levels before, during, and after dosing
63747|NCT01990794|O1|Outcome|Female Hgb|Hgb levels before, during and after dosing
63748|NCT01990794|O2|Outcome|SI After Cobalt Supplementation|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT)."
63749|NCT01990794|O1|Outcome|SI Before Cobalt Supplementation|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT)."
63750|NCT01990794|O1|Outcome|Albumin-Co Fraction|Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
63751|NCT01990794|E1|Reported Event|Study Volunteers|"Study volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
63752|NCT01990703|B3|Baseline|Total|Total of all reporting groups
63753|NCT01990703|B2|Baseline|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum
Levonorgestrel IUD: Timing of IUD insertion"
63754|NCT01990703|B1|Baseline|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD
Levonorgestrel IUD: Timing of IUD insertion"
63755|NCT01990703|P2|Participant Flow|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum
Levonorgestrel IUD: Timing of IUD insertion"
63756|NCT01990703|P1|Participant Flow|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD
Levonorgestrel IUD: Timing of IUD insertion"
65522|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
63757|NCT01990703|O2|Outcome|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum
Levonorgestrel IUD: Timing of IUD insertion"
63758|NCT01990703|O1|Outcome|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD
Levonorgestrel IUD: Timing of IUD insertion"
63759|NCT01990703|O2|Outcome|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum
Levonorgestrel IUD: Timing of IUD insertion"
63760|NCT01990703|O1|Outcome|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD
Levonorgestrel IUD: Timing of IUD insertion"
63761|NCT01990703|E2|Reported Event|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum
Levonorgestrel IUD: Timing of IUD insertion"
63762|NCT01990703|E1|Reported Event|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD
Levonorgestrel IUD: Timing of IUD insertion"
63763|NCT01990677|B3|Baseline|Total|Total of all reporting groups
63764|NCT01990677|B2|Baseline|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63774|NCT01990677|E2|Reported Event|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63877|NCT01989455|P2|Participant Flow|1000 mg Deferiprone|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL), followed one week later by a single oral dose of 1000 mg deferiprone oral solution, 80 mg/mL
63765|NCT01990677|B1|Baseline|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63766|NCT01990677|P2|Participant Flow|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63767|NCT01990677|P1|Participant Flow|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63768|NCT01990677|O2|Outcome|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63769|NCT01990677|O1|Outcome|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63770|NCT01990677|O2|Outcome|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63771|NCT01990677|O1|Outcome|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63808|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
63772|NCT01990677|O2|Outcome|Placebo- Chronic CSCR Diagnosis|"Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63773|NCT01990677|O1|Outcome|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63876|NCT01989455|P3|Participant Flow|1500 mg Deferiprone|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63879|NCT01989455|O1|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
63775|NCT01990677|E1|Reported Event|25mg Eplerenone- Chronic CSCR Diagnosis|"Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
25mg Eplerenone: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
Placebo: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo."
63776|NCT01990664|B3|Baseline|Total|Total of all reporting groups
63777|NCT01990664|B2|Baseline|Test (Senofilcon A)|Consists of subjects that were dispensed at least one Test lens.
63778|NCT01990664|B1|Baseline|Control (Senfilcon A)|Consists of subjects that were dispensed at least one Control lens.
63779|NCT01990664|P2|Participant Flow|Test (Senofilcon A)|Subjects that were randomized to receive theTest lens for the duration of the study.
63780|NCT01990664|P1|Participant Flow|Control (Senfilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
63781|NCT01990664|O2|Outcome|Test (Senofilcon A)|Subjects that were randomized to receive the Test lens for the duration of the study.
63782|NCT01990664|O1|Outcome|Control (Senofilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
63783|NCT01990664|E2|Reported Event|Test (Senofilcon A)|Subjects that were randomized to receive the Test lens for the duration of the study.
63784|NCT01990664|E1|Reported Event|Control (Senofilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
63785|NCT01990534|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63786|NCT01990534|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63787|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63788|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63789|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63790|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63791|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63837|NCT01989572|P5|Participant Flow|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC"
63792|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63793|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63794|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63795|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63796|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63797|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63798|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63799|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63800|NCT01990534|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
63801|NCT01990339|B1|Baseline|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
63802|NCT01990339|P1|Participant Flow|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
63803|NCT01990339|O1|Outcome|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
63804|NCT01990339|O1|Outcome|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
63805|NCT01990339|E1|Reported Event|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
63806|NCT01990261|B1|Baseline|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
63807|NCT01990261|P1|Participant Flow|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
63910|NCT01989455|E1|Reported Event|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63809|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
63810|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
63811|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
63812|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
63813|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
63814|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
63878|NCT01989455|P1|Participant Flow|500 mg Deferiprone|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63815|NCT01990261|E1|Reported Event|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
63816|NCT01989689|B3|Baseline|Total|Total of all reporting groups
63817|NCT01989689|B2|Baseline|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63818|NCT01989689|B1|Baseline|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63819|NCT01989689|P2|Participant Flow|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63820|NCT01989689|P1|Participant Flow|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63821|NCT01989689|O2|Outcome|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63822|NCT01989689|O1|Outcome|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63823|NCT01989689|O2|Outcome|Placebo/ Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63824|NCT01989689|O1|Outcome|Etanercept/ Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63825|NCT01989689|O2|Outcome|Placebo/ Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63826|NCT01989689|O1|Outcome|Etanercept/ Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63827|NCT01989689|E2|Reported Event|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63828|NCT01989689|E1|Reported Event|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.
Etanercept: Etanercept 50mg twice weekly
Placebo"
63829|NCT01989572|B7|Baseline|Total|Total of all reporting groups
63830|NCT01989572|B6|Baseline|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC"
63831|NCT01989572|B5|Baseline|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC"
63832|NCT01989572|B4|Baseline|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC"
63833|NCT01989572|B3|Baseline|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC"
63834|NCT01989572|B2|Baseline|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
peptide vaccine: Given SC
GM-CSF placebo: Given SC"
63835|NCT01989572|B1|Baseline|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide vaccine: Given SC"
63836|NCT01989572|P6|Participant Flow|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC"
63838|NCT01989572|P4|Participant Flow|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC"
63839|NCT01989572|P3|Participant Flow|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC"
63840|NCT01989572|P2|Participant Flow|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
peptide vaccine: Given SC
GM-CSF placebo: Given SC"
63841|NCT01989572|P1|Participant Flow|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide vaccine: Given SC"
63842|NCT01989572|O6|Outcome|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC"
63843|NCT01989572|O5|Outcome|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC"
63844|NCT01989572|O4|Outcome|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC"
63845|NCT01989572|O3|Outcome|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC"
63846|NCT01989572|O2|Outcome|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
peptide vaccine: Given SC
GM-CSF placebo: Given SC"
63847|NCT01989572|O1|Outcome|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide vaccine: Given SC"
63848|NCT01989572|O6|Outcome|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC"
63849|NCT01989572|O5|Outcome|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC"
63850|NCT01989572|O4|Outcome|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC
peptide placebo: Given SC"
63851|NCT01989572|O3|Outcome|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide placebo: Given SC"
63852|NCT01989572|O2|Outcome|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
peptide vaccine: Given SC
GM-CSF placebo: Given SC"
63853|NCT01989572|O1|Outcome|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC
peptide vaccine: Given SC"
63854|NCT01989572|O2|Outcome|Peptide Placebo|Patients who were HLA-A2 positive and received peptide placebo in the trial, including 109 patients on arms III and 107 patients on arm IV
63855|NCT01989572|O1|Outcome|Peptide Vaccination|Patients who were HLA-A2 positive and received peptide vaccine in the trial, including 109 patients on arm I and 111 patients on arm II.
63856|NCT01989572|O2|Outcome|Peptide Placebo|Patients who were HLA-A2 positive and received peptide placebo in the trial, including 109 patients on arms III and 107 patients on arm IV
63857|NCT01989572|O1|Outcome|Peptide Vaccination|Patients who were HLA-A2 positive and received peptide vaccine in the trial, including 109 patients on arm I and 111 patients on arm II.
63858|NCT01989572|O2|Outcome|GM-CSF Placebo|Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
63859|NCT01989572|O1|Outcome|GM-CSF|Patients received GM-CSF in the trial, including patients on arms I, III, V.
63860|NCT01989572|O2|Outcome|GM-CSF Placebo|Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
63861|NCT01989572|O1|Outcome|GM-CSF|Patients received GM-CSF in the trial, including patients on arms I, III, V.
63862|NCT01989572|E6|Reported Event|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.
GM-CSF placebo: Given SC"
63863|NCT01989572|E5|Reported Event|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.
sargramostim: Given SC"
63864|NCT01989572|E4|Reported Event|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Arm IV (GM-CSF placebo, peptide placebo) Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
GM-CSF placebo: Given SC peptide placebo: Given SC"
63865|NCT01989572|E3|Reported Event|Arm III (GM-CSF, Peptide Placebo)|"Arm III (GM-CSF, peptide placebo) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC peptide placebo: Given SC"
63942|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63866|NCT01989572|E2|Reported Event|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Arm II (GM-CSF placebo, peptide vaccine) Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
peptide vaccine: Given SC GM-CSF placebo: Given SC"
63867|NCT01989572|E1|Reported Event|Arm I (GM-CSF, Peptide Vaccine)|"Arm I (GM-CSF, peptide vaccine) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
sargramostim: Given SC peptide vaccine: Given SC"
63868|NCT01989455|B6|Baseline|Total|Total of all reporting groups
63869|NCT01989455|B5|Baseline|Placebo|Single intravenous dose of placebo (normal saline solution).
63870|NCT01989455|B4|Baseline|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63871|NCT01989455|B3|Baseline|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63872|NCT01989455|B2|Baseline|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63873|NCT01989455|B1|Baseline|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63874|NCT01989455|P5|Participant Flow|Placebo|Single intravenous dose of placebo (normal saline solution).
63875|NCT01989455|P4|Participant Flow|2000 mg Deferiprone|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63880|NCT01989455|O2|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
63881|NCT01989455|O1|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63882|NCT01989455|O2|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
63883|NCT01989455|O1|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63884|NCT01989455|O5|Outcome|Placebo|Single intravenous dose of placebo (normal saline solution).
63885|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63886|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63887|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63888|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63889|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63890|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63891|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63892|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63893|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63894|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63895|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63896|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63897|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63898|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63899|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63900|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63901|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63902|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63903|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63904|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63905|NCT01989455|E6|Reported Event|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
63906|NCT01989455|E5|Reported Event|Placebo|Single intravenous dose of placebo (normal saline solution).
63907|NCT01989455|E4|Reported Event|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63908|NCT01989455|E3|Reported Event|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63909|NCT01989455|E2|Reported Event|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
63911|NCT01989195|B1|Baseline|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY
‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT
CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)
CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
63912|NCT01989195|P1|Participant Flow|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY
‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT
CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)
CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
63913|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY
‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT
CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)
CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
63914|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY
‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT
CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)
CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI
Outcome measurement followed for both as all subjects received both MEMRI and DEMRI."
63915|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY
‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT
CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)
CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
63956|NCT01989156|E1|Reported Event|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63957|NCT01989130|B3|Baseline|Total|Total of all reporting groups
63916|NCT01989195|O2|Outcome|INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI)|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY
MEMRI- SeeMore
CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)
CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MR"
63917|NCT01989195|O1|Outcome|DEMRI CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY
DEMRI - MAGNEVIST (GADOLINIUM)
CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)
CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
63918|NCT01989195|E1|Reported Event|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY
‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH CLINICAL MAGNEVIST (GADOLINIUM), ONE WITH EXPERIMENTAL SEEMORE (MANGANESE) REAGENT. ADVERSE EVENTS TRACKED FOR SEEMORE MRI.
- CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
63919|NCT01989169|B3|Baseline|Total|Total of all reporting groups
63920|NCT01989169|B2|Baseline|Midazolam + SSP-004184SS First|Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.
63921|NCT01989169|B1|Baseline|Midazolam First|Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.
63922|NCT01989169|P2|Participant Flow|Midazolam + SSP-004184SS First|Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.
63923|NCT01989169|P1|Participant Flow|Midazolam First|Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.
63924|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
63925|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
63926|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
63927|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
63928|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
63929|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
63930|NCT01989169|E2|Reported Event|Midazolam + SSP-004184SS|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
63931|NCT01989169|E1|Reported Event|Midazolam Alone|Administered as a single oral 20 mg dose on Day 1.
63932|NCT01989156|B4|Baseline|Total|Total of all reporting groups
63933|NCT01989156|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63934|NCT01989156|B2|Baseline|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63935|NCT01989156|B1|Baseline|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63936|NCT01989156|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63937|NCT01989156|P2|Participant Flow|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63938|NCT01989156|P1|Participant Flow|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63939|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63940|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63941|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63943|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63944|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63945|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63946|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63947|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63948|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63949|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63950|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63951|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63952|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63953|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63954|NCT01989156|E3|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
63955|NCT01989156|E2|Reported Event|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
65972|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system
AVERT"
63958|NCT01989130|B2|Baseline|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED
Roche AMPLICOR CT/NG"
63959|NCT01989130|B1|Baseline|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory
Cepheid Xpert CT/NG Test"
63960|NCT01989130|P2|Participant Flow|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED
Roche AMPLICOR CT/NG"
63961|NCT01989130|P1|Participant Flow|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory
Cepheid Xpert CT/NG Test"
63962|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED
Roche AMPLICOR CT/NG"
63963|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory
Cepheid Xpert CT/NG Test"
63964|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED
Roche AMPLICOR CT/NG"
63965|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory
Cepheid Xpert CT/NG Test"
63966|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED
Roche AMPLICOR CT/NG"
63967|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory
Cepheid Xpert CT/NG Test"
63968|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED
Roche AMPLICOR CT/NG"
63969|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory
Cepheid Xpert CT/NG Test"
63970|NCT01989130|E2|Reported Event|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED
Roche AMPLICOR CT/NG"
63971|NCT01989130|E1|Reported Event|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory
Cepheid Xpert CT/NG Test"
63972|NCT01988857|B1|Baseline|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
63973|NCT01988857|P1|Participant Flow|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
63974|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
63975|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
63976|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
63977|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
63978|NCT01988857|E1|Reported Event|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
63979|NCT01988662|B3|Baseline|Total|Total of all reporting groups
63980|NCT01988662|B2|Baseline|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63981|NCT01988662|B1|Baseline|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63982|NCT01988662|P2|Participant Flow|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
64308|NCT01987349|B3|Baseline|Group B: Age 18-30 yo Identical Twins|Participants to receive FluMist® (intranasal)
63983|NCT01988662|P1|Participant Flow|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63984|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63985|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63986|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63987|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63988|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63989|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63990|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
64811|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
63991|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63992|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63993|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63994|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63995|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63996|NCT01988662|E3|Reported Event|Total|
63997|NCT01988662|E2|Reported Event|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63998|NCT01988662|E1|Reported Event|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
63999|NCT01988415|B1|Baseline|VSS-Rx1 OPM vs Commercial iDesign Treatment|Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
64000|NCT01988415|P1|Participant Flow|VSS-Rx1 OPM vs Commercial iDesign Treatment|Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
64001|NCT01988415|O2|Outcome|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
64002|NCT01988415|O1|Outcome|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
64003|NCT01988415|O2|Outcome|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
64004|NCT01988415|O1|Outcome|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
64005|NCT01988415|E2|Reported Event|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
64006|NCT01988415|E1|Reported Event|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
64007|NCT01988402|B3|Baseline|Total|Total of all reporting groups
64008|NCT01988402|B2|Baseline|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Placebo (sugar pill)"
64009|NCT01988402|B1|Baseline|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol"
64010|NCT01988402|P2|Participant Flow|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Placebo (sugar pill)"
64011|NCT01988402|P1|Participant Flow|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol"
64012|NCT01988402|O2|Outcome|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Placebo (sugar pill)"
64013|NCT01988402|O1|Outcome|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol"
64014|NCT01988402|O2|Outcome|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Placebo (sugar pill)"
64015|NCT01988402|O1|Outcome|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol"
64016|NCT01988402|E2|Reported Event|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Placebo (sugar pill)"
64017|NCT01988402|E1|Reported Event|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
allopurinol"
64018|NCT01988129|B3|Baseline|Total|Total of all reporting groups
64019|NCT01988129|B2|Baseline|Control|Current practice
64058|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64135|NCT01987908|P1|Participant Flow|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
64020|NCT01988129|B1|Baseline|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64021|NCT01988129|P2|Participant Flow|Control|"Current practice.
Current practice. Firefighters in the Control Stations continued their normal role and were not invited to attend the sleep education and sleep disorders screening program. There was no formal contact with the control group.
As part of normal operational requirements, a small number of firefighters are reassigned to other stations each day and therefore 18/588 firefighters from control stations happened to be reassigned to an intervention station on the day of the education session and attended the session."
64022|NCT01988129|P1|Participant Flow|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening.
32 stations were paired according to workload. One from each pair was randomized to receive the intervention program. Firefighters were instructed to attend an education presentation which provided information on firefighter mortality, fatigue-related hazards and discussed the importance of sleep, and included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64023|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
64024|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64025|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
64026|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64027|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
64076|NCT01987986|P3|Participant Flow|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64028|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64029|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
64059|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64084|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64136|NCT01987908|O1|Outcome|Overall Study Arm|
64030|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64031|NCT01988129|O1|Outcome|Baseline (Intervention)|Firefighters in the intervention group who volunteered to complete the sleep disorders screening survey
64032|NCT01988129|O2|Outcome|Control|Current practice
64033|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64034|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
64035|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64036|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
64037|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64038|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
64039|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64040|NCT01988129|O2|Outcome|Control|Current practice
64055|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64041|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64042|NCT01988129|O2|Outcome|Control|Current practice
64083|NCT01987986|O4|Outcome|Placebo|"Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo"
64043|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64044|NCT01988129|O2|Outcome|Control|Current practice
64045|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
64046|NCT01988129|E2|Reported Event|Control|A total of 15/588 firefighters in the control stations who were temporarily assigned to duty in the intervention stations on the day of the survey completed the screening survey. The remaining 573 firefighters did not complete the survey and therefore there are no adverse event data to report.
64047|NCT01988129|E1|Reported Event|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, including strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey which used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. Those who screened positive for any sleep disorder were notified as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up. Of the 431 firefighters completed the sleep disorders screening survey, 416 were from the intervention stations."
64048|NCT01988012|B1|Baseline|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64049|NCT01988012|P1|Participant Flow|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 milligram (mg) tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64050|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64051|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64052|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64053|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64054|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
65523|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
64056|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64057|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64137|NCT01987908|O1|Outcome|Overall Study Arm|
64060|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64061|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64062|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64063|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64064|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64065|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64066|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64067|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64068|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64069|NCT01988012|E1|Reported Event|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
64070|NCT01987986|B5|Baseline|Total|Total of all reporting groups
64071|NCT01987986|B4|Baseline|Placebo|"Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo"
64072|NCT01987986|B3|Baseline|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64073|NCT01987986|B2|Baseline|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64074|NCT01987986|B1|Baseline|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64075|NCT01987986|P4|Participant Flow|Placebo|"Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo"
64077|NCT01987986|P2|Participant Flow|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64078|NCT01987986|P1|Participant Flow|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64079|NCT01987986|O4|Outcome|Placebo|"Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo"
64080|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64081|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64082|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64085|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64086|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64087|NCT01987986|O4|Outcome|Placebo|"Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo"
64088|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64089|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64090|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64091|NCT01987986|O4|Outcome|Placebo|"Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo"
64092|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64093|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64094|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64095|NCT01987986|O4|Outcome|Placebo|"Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo"
64096|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64097|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64098|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64099|NCT01987986|O4|Outcome|Placebo|"Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo"
64100|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64101|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64102|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64103|NCT01987986|O4|Outcome|Placebo|"Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo"
64835|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
64104|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64105|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64106|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64107|NCT01987986|O4|Outcome|Placebo|"Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo"
64108|NCT01987986|O3|Outcome|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64109|NCT01987986|O2|Outcome|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64110|NCT01987986|O1|Outcome|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64111|NCT01987986|E4|Reported Event|Placebo|"Placebo
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Placebo"
64112|NCT01987986|E3|Reported Event|AA4500 0.84 mg (High Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64113|NCT01987986|E2|Reported Event|AA4500 0.48 mg (Mid-dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64114|NCT01987986|E1|Reported Event|AA4500 0.06 mg (Low Dose)|"AA4500 (Collagenase Clostridium Histolyticum)
Each subject could receive up to three treatment sessions. Each treatment session was separated by approximately 21 days.
Collagenase Clostridium Histolyticum: injectible intervention"
64115|NCT01987960|B3|Baseline|Total|Total of all reporting groups
64116|NCT01987960|B2|Baseline|Period 2 Brexpiprazole and PAR/SER (Randomized Period)|"Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.
Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
64117|NCT01987960|B1|Baseline|Period 2 Placebo and PAR/SER (Randomized Period)|"Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.
Placebo: Once daily, tablets, orally"
64118|NCT01987960|P4|Participant Flow|Period 3 Placebo and PAR/SER|"Continuation of treatment with placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) from Period 1.
Placebo: Once daily, tablets, orally"
64119|NCT01987960|P3|Participant Flow|Period 2 Brexpiprazole and PAR/SER (Randomized Period)|"Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period
Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
64120|NCT01987960|P2|Participant Flow|Period 2 Placebo and PAR/SER (Randomized Period)|"Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.
Placebo: Once daily, tablets, orally"
64121|NCT01987960|P1|Participant Flow|Period 1 Placebo and PAR/SER|"Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER).
Placebo: Once daily, tablets, orally"
64122|NCT01987960|O4|Outcome|Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.
Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day. Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24)."
64123|NCT01987960|O3|Outcome|Period 2 Absolute Mean at Week 12; Placebo and PAR/SER|Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) Placebo: Once daily, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24); randomized period.
64124|NCT01987960|O2|Outcome|Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.
Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
64125|NCT01987960|O1|Outcome|Period 2 Absolute Mean at Baseline; Placebo and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.
Placebo: Once daily, tablets, orally"
64126|NCT01987960|O4|Outcome|Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.
Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally
Absolute values at Week 12 in Period 2 (Study Week 24)"
65396|NCT01978600|E1|Reported Event|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
64127|NCT01987960|O3|Outcome|Period 2 Absolute Mean at Week 12; Placebo and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.
Placebo: Once daily, tablets, orally
Absolute values at Week 12 in Period 2 (Study Week 24)"
64128|NCT01987960|O2|Outcome|Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.
Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
64129|NCT01987960|O1|Outcome|Period 2 Absolute Mean at Baseline; Placebo and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.
Placebo: Once daily, tablets, orally"
64130|NCT01987960|E2|Reported Event|Placebo + PAR/SER (Randomized Period)|
64131|NCT01987960|E1|Reported Event|Brexpiprazole + PAR/SER (Randomized Period)|
64132|NCT01987908|B1|Baseline|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
64133|NCT01987908|P3|Participant Flow|Treatment With Placebo|After placebo lead-in period, participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days during the double-blind treatment period
64134|NCT01987908|P2|Participant Flow|Treatment With Study Product|After placebo lead-in period, participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days during the double-blind treatment period
65897|NCT01976442|B1|Baseline|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
64138|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
64139|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64140|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64141|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64142|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
64143|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64144|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64145|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64146|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64147|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64148|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
64149|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64150|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
64151|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64152|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
64153|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64154|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
64155|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64156|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64157|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64158|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64159|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64160|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
64161|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64162|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
64163|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64164|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64165|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64166|NCT01987908|O1|Outcome|Overall Study Arm|
64167|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
64168|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64169|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
64170|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64171|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64172|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64173|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64174|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64175|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64176|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64177|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64178|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64179|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64180|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64181|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64182|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64183|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64184|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64185|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64186|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64187|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64188|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64189|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64190|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64191|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64192|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64193|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64194|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64195|NCT01987908|O1|Outcome|Overall Study Arm|Data not collected
64196|NCT01987908|O4|Outcome|Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received (Day 29 to Day 49)
64197|NCT01987908|O3|Outcome|Double-blind Treatment Period - Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of placebo for 28 days (Day 1 to Day 28)
64198|NCT01987908|O2|Outcome|Double-blind Treatment Period - Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days (Day 1 to Day 28)
64199|NCT01987908|O1|Outcome|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo (Day -14 to Day -1)
64200|NCT01987908|O5|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no placebo was received
64201|NCT01987908|O4|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64202|NCT01987908|O3|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64203|NCT01987908|O2|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64204|NCT01987908|O1|Outcome|Placebo Lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
64205|NCT01987908|O3|Outcome|All Participants in Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received
64206|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no placebo was received
64207|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
64208|NCT01987908|O1|Outcome|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
64209|NCT01987908|O3|Outcome|All Treated Participants|All participants randomized 3:1 (Aes-103 to placebo) and received 4 times daily dosing of 1,000 mg AEs-103 or 1,000 mg of placebo for 28 days
64210|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
64211|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
64212|NCT01987908|E3|Reported Event|Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received (Day 29 to Day 49)
64213|NCT01987908|E2|Reported Event|Double-blind Treatment Period|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of either 1,000 mg of Aes-103 (study product) or placebo for 28 days (Day 1 to Day 28)
64214|NCT01987908|E1|Reported Event|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo (Day -14 to Day -1)
64215|NCT01987765|B1|Baseline|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
64216|NCT01987765|P1|Participant Flow|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
64217|NCT01987765|O1|Outcome|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
64218|NCT01987765|O1|Outcome|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
64219|NCT01987765|E1|Reported Event|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
64220|NCT01987752|B1|Baseline|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
64221|NCT01987752|P1|Participant Flow|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
64222|NCT01987752|O1|Outcome|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
64223|NCT01987752|O1|Outcome|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
64224|NCT01987752|E1|Reported Event|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
64225|NCT01987583|B3|Baseline|Total|Total of all reporting groups
64226|NCT01987583|B2|Baseline|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
64227|NCT01987583|B1|Baseline|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.
Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
64228|NCT01987583|P2|Participant Flow|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
64229|NCT01987583|P1|Participant Flow|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.
Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
64276|NCT01987453|B2|Baseline|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
64230|NCT01987583|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
64231|NCT01987583|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.
Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
64232|NCT01987583|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
64254|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64255|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64233|NCT01987583|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.
Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
64234|NCT01987583|E2|Reported Event|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
64235|NCT01987583|E1|Reported Event|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.
Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
64236|NCT01987557|B4|Baseline|Total|Total of all reporting groups
64237|NCT01987557|B3|Baseline|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill
regular treadmill walking"
64238|NCT01987557|B2|Baseline|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs
magnitude treadmill group"
64239|NCT01987557|B1|Baseline|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.
rate group: walking with a high cadence (steps per minute)"
64240|NCT01987557|P3|Participant Flow|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill
regular treadmill walking"
64241|NCT01987557|P2|Participant Flow|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs
magnitude treadmill group"
64242|NCT01987557|P1|Participant Flow|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.
rate group: walking with a high cadence (steps per minute)"
64243|NCT01987557|O3|Outcome|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill
regular treadmill walking"
64244|NCT01987557|O2|Outcome|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs
magnitude treadmill group"
64245|NCT01987557|O1|Outcome|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.
rate group: walking with a high cadence (steps per minute)"
64246|NCT01987557|E3|Reported Event|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill
regular treadmill walking"
64247|NCT01987557|E2|Reported Event|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs
magnitude treadmill group"
64307|NCT01987349|B4|Baseline|Group C: Age 18-30 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
64248|NCT01987557|E1|Reported Event|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.
rate group: walking with a high cadence (steps per minute)"
64249|NCT01987479|B1|Baseline|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64250|NCT01987479|P1|Participant Flow|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly subcutaneous (SC) injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) for 24 weeks.
64251|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64252|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64253|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64439|NCT01986985|B1|Baseline|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image
PET/MRI system: Compared to PET CT"
64256|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64257|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64258|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64259|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64260|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64261|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64262|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64263|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64264|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64265|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64266|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64267|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64268|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64269|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64270|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64271|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64272|NCT01987479|O1|Outcome|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64273|NCT01987479|E1|Reported Event|Tocilizumab Alone or in Combination With Methotrexate or DMARD|Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
64274|NCT01987453|B4|Baseline|Total|Total of all reporting groups
64275|NCT01987453|B3|Baseline|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
65524|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
64277|NCT01987453|B1|Baseline|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
64278|NCT01987453|P3|Participant Flow|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
64279|NCT01987453|P2|Participant Flow|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
64280|NCT01987453|P1|Participant Flow|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
64281|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
64282|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
64283|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
64321|NCT01987349|O6|Outcome|Group E: 40-49 yo Fraternal Twins|"Participants to receive FluMist® (intranasal)
FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64284|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
64285|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
64286|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
64287|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
64288|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
64289|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
64290|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
64291|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
64292|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
64293|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
64294|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
64295|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
64296|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
64297|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF ± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
64298|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
64299|NCT01987453|E3|Reported Event|LDV/SOF + RBV 24 Week (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
64300|NCT01987453|E2|Reported Event|LDV/SOF 24 Week (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
64301|NCT01987453|E1|Reported Event|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
64302|NCT01987349|B9|Baseline|Total|Total of all reporting groups
64303|NCT01987349|B8|Baseline|Group G: 70-100 yo Nontwins|Participants to receive Fluzone® (intramuscular)
64304|NCT01987349|B7|Baseline|Group F: 70-100 yo Identical Twins|Participants to receive Fluzone® (intramuscular)
64305|NCT01987349|B6|Baseline|Group E: Age 40-49 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
64306|NCT01987349|B5|Baseline|Group D: Age 40-49 yo Identical Twins|Participants to receive FluMist® (intranasal)
64309|NCT01987349|B2|Baseline|Group A: Age 8-17 yo Identical Twins (FluMist)|Participants will be randomized to receive FluMist® (intranasal)
64310|NCT01987349|B1|Baseline|Group A: Age 8-17 yo Identical Twins (Fluzone)|Participants will be randomized to receive Fluzone® (intramuscular)
64311|NCT01987349|P8|Participant Flow|Group G: 70-100 yo Nontwins|Participants to receive Fluzone® (intramuscular)
64312|NCT01987349|P7|Participant Flow|Group F: 70-100 yo Identical Twins|Participants to receive Fluzone® (intramuscular)
64313|NCT01987349|P6|Participant Flow|Group E: Age 40-49 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
64314|NCT01987349|P5|Participant Flow|Group D: Age 40-49 yo Identical Twins|Participants to receive FluMist® (intranasal)
64315|NCT01987349|P4|Participant Flow|Group C: Age 18-30 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
64316|NCT01987349|P3|Participant Flow|Group B: Age 18-30 yo Identical Twins|Participants to receive FluMist® (intranasal)
64317|NCT01987349|P2|Participant Flow|Group A: Age 8-17yo Identical Twins|Participants will be randomized to receive FluMist® (intranasal)
64318|NCT01987349|P1|Participant Flow|Group A: Age 8-17 yo Identical Twins|Participants will be randomized to receive Fluzone® (intramuscular)
64319|NCT01987349|O8|Outcome|Group G: 70-100 yo Non-twins|"Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
64320|NCT01987349|O7|Outcome|Group F: 70-100 yo Twins|"Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
64440|NCT01986985|P1|Participant Flow|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image
PET/MRI system: Compared to PET CT"
64322|NCT01987349|O5|Outcome|Group D: 40-49 yo Identical Twins|"Participants to receive FluMist® (intranasal)
FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64323|NCT01987349|O4|Outcome|Group C: 18-30 yo Fraternal Twins|"Participants to receive FluMist® (intranasal)
FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64324|NCT01987349|O3|Outcome|Group B: 18-30 yo Identical Twins|"Participants to receive FluMist® (intranasal)
FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64325|NCT01987349|O2|Outcome|Group A: Age 8-17 yo Identical Twins (IN)|"Participants will be randomized to receive FluMist® (intranasal)
FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64326|NCT01987349|O1|Outcome|Group A: Age 8-17 yo Identical Twins (IM)|"Participants will be randomized to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
64327|NCT01987349|O8|Outcome|Group G: 70-100 yo Non-twins|"Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
64328|NCT01987349|O7|Outcome|Group F: 70-100 yo Twins|"Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
64329|NCT01987349|O6|Outcome|Group E: 40-49 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64330|NCT01987349|O5|Outcome|Group D: 40-49 yo Identical Twins|"Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64331|NCT01987349|O4|Outcome|Group C: 18-30 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64332|NCT01987349|O3|Outcome|Group B: 18-30 yo Identical Twins|"Participants to receive FluMist® (intranasal)
FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64333|NCT01987349|O2|Outcome|Group A: Age 8-17 yo Identical Twins (IN)|"Participants will be randomized to receive FluMist® (intranasal
FluMist®: Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64334|NCT01987349|O1|Outcome|Group A: Age 8-17 yo Identical Twins (IM)|"Participants will be randomized to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
64335|NCT01987349|E8|Reported Event|Group G: 70-100 yo Non-twins|"Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
64336|NCT01987349|E7|Reported Event|Group F: 70-100 yo Twins|"Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
64337|NCT01987349|E6|Reported Event|Group E: 40-49 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64338|NCT01987349|E5|Reported Event|Group D: 40-49 yo Identical Twins|"Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64339|NCT01987349|E4|Reported Event|Group C: 18-30 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64340|NCT01987349|E3|Reported Event|Group B: 18-30 yo Identical Twin Pairs|"Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
64341|NCT01987349|E2|Reported Event|Group A: Age 8-17 yo Identical Twins (Flumist)|Participants will be randomized to receive Flumist® (intranasal)
64342|NCT01987349|E1|Reported Event|Group A: Age 8-17 yo Identical Twins (Fluzone)|Participants will be randomized to receive Fluzone® (intramuscular)
64343|NCT01987232|B6|Baseline|Total|Total of all reporting groups
64344|NCT01987232|B5|Baseline|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
65525|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
64345|NCT01987232|B4|Baseline|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64346|NCT01987232|B3|Baseline|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64347|NCT01987232|B2|Baseline|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64348|NCT01987232|B1|Baseline|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
65964|NCT01976299|P1|Participant Flow|Active Treatment|"Standard of Care with the AVERT system
AVERT"
64349|NCT01987232|P5|Participant Flow|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64350|NCT01987232|P4|Participant Flow|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64351|NCT01987232|P3|Participant Flow|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64352|NCT01987232|P2|Participant Flow|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64353|NCT01987232|P1|Participant Flow|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target area under the curve (AUC) of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64354|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64355|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64356|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64357|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64358|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64636|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64359|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64360|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target area AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64361|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64362|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
65965|NCT01976299|O2|Outcome|Standard of Care|
64363|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64364|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64365|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64366|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64367|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64368|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64369|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64370|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64371|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64372|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64373|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64374|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64375|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64376|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64377|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64378|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64379|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64380|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64381|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64382|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64383|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64384|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64385|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64386|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64387|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64429|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours
Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
64430|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA
placebo: Saline solution 3 cc NA"
64388|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64389|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64390|NCT01987232|O6|Outcome|All Participants|Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64391|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
65973|NCT01976299|O2|Outcome|Standard of Care|
64392|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64393|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64394|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64395|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64396|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64397|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64398|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64399|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64400|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64401|NCT01987232|O5|Outcome|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64431|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide
Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
64747|NCT01984684|B3|Baseline|Total|Total of all reporting groups
64402|NCT01987232|O4|Outcome|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64403|NCT01987232|O3|Outcome|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64404|NCT01987232|O2|Outcome|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64438|NCT01987219|E1|Reported Event|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours
Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
65966|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system
AVERT"
64405|NCT01987232|O1|Outcome|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64406|NCT01987232|E5|Reported Event|Carfilzomib 20/56 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64407|NCT01987232|E4|Reported Event|Carfilzomib 20/45 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64408|NCT01987232|E3|Reported Event|Carfilzomib 20/36 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64409|NCT01987232|E2|Reported Event|Carfilzomib 20/27 mg/m²|Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64410|NCT01987232|E1|Reported Event|Carfilzomib 20/20 mg/m²|Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
64411|NCT01987219|B7|Baseline|Total|Total of all reporting groups
64412|NCT01987219|B6|Baseline|Ipratropium; Placebo; Albuterol|
64413|NCT01987219|B5|Baseline|Placebo; Albuterol; Ipratropium|
64414|NCT01987219|B4|Baseline|Placebo; Ipratropium; Albuterol|
64415|NCT01987219|B3|Baseline|Albuterol; Ipratropium; Placebo|
64416|NCT01987219|B2|Baseline|Albuterol; Placebo; Ipratropium|
64417|NCT01987219|B1|Baseline|Ipratropium; Alubterol; Placebo|
64418|NCT01987219|P6|Participant Flow|Ipratropium; Placebo; Albuterol|Participants in this group received ipratropium followed by placebo followed by albuterol
64419|NCT01987219|P5|Participant Flow|Placebo; Albuterol; Ipratropium|Participants in this group received placebo followed by albuterol followed by ipratropium
64420|NCT01987219|P4|Participant Flow|Placebo; Ipratropium; Albuterol|Participants in this group received placebo followed by ipratropium followed by albuterol
64421|NCT01987219|P3|Participant Flow|Albuterol; Ipratropium; Placebo|Participants in this group received albuterol followed by ipratropium followed by placebo
64422|NCT01987219|P2|Participant Flow|Albuterol; Placebo; Ipratropium|Participants in this group received albuterol followed by placebo followed by ipratropium
64423|NCT01987219|P1|Participant Flow|Ipratropium; Alubterol; Placebo|Participants in this group received ipratropium followed by albuterol followed by placebo
64424|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA
placebo: Saline solution 3 cc NA"
64425|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide
Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
64426|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours
Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
64427|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA
placebo: Saline solution 3 cc NA"
64428|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide
Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
64432|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours
Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
64433|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA
placebo: Saline solution 3 cc NA"
64434|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide
Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
64435|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours
Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
64436|NCT01987219|E3|Reported Event|Placebo|"Placebo Saline solution 3 cc NA
placebo: Saline solution 3 cc NA"
64437|NCT01987219|E2|Reported Event|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide
Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
64441|NCT01986985|O1|Outcome|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image
PET/MRI system: Compared to PET CT"
64442|NCT01986985|E1|Reported Event|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image
PET/MRI system: Compared to PET CT"
64443|NCT01986946|B3|Baseline|Total|Total of all reporting groups
64444|NCT01986946|B2|Baseline|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64445|NCT01986946|B1|Baseline|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
64446|NCT01986946|P2|Participant Flow|Epidural Catheter|"The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.
Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery."
64447|NCT01986946|P1|Participant Flow|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
64448|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64449|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64450|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64451|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64452|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64453|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64454|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64455|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64456|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64576|NCT01985581|O2|Outcome|GXR and Stimulant|The child's quality of life as assessed by the parent was measured in subjects taking usual stimulant and GXR (optimized dose 1-4 mg)
64457|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64458|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64459|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64460|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64461|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64462|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64488|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.
Plain Language"
64463|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64464|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64465|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64466|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64467|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64468|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64469|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64470|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64471|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64472|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64473|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
64474|NCT01986946|E2|Reported Event|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
64475|NCT01986946|E1|Reported Event|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
64476|NCT01986790|B4|Baseline|Total|Total of all reporting groups
64477|NCT01986790|B3|Baseline|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.
Plain Language + Narratives"
64478|NCT01986790|B2|Baseline|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.
Plain Language + Visuals"
64479|NCT01986790|B1|Baseline|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.
Plain Language"
64480|NCT01986790|P3|Participant Flow|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.
Plain Language + Narratives"
64481|NCT01986790|P2|Participant Flow|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.
Plain Language + Visuals"
64482|NCT01986790|P1|Participant Flow|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.
Plain Language"
64483|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.
Plain Language + Narratives"
64484|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.
Plain Language + Visuals"
64485|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.
Plain Language"
64486|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.
Plain Language + Narratives"
64487|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.
Plain Language + Visuals"
64489|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.
Plain Language + Narratives"
64490|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.
Plain Language + Visuals"
64491|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.
Plain Language"
64492|NCT01986790|E3|Reported Event|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.
Plain Language + Narratives"
64493|NCT01986790|E2|Reported Event|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.
Plain Language + Visuals"
64494|NCT01986790|E1|Reported Event|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.
Plain Language"
64495|NCT01986751|B3|Baseline|Total|Total of all reporting groups
64496|NCT01986751|B2|Baseline|Ropivacaine|"Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine
ropivacaine"
64497|NCT01986751|B1|Baseline|Clonidine and Ropivacaine|"A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).
Clonidine
ropivacaine"
64498|NCT01986751|P2|Participant Flow|Ropivacaine|"Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine
ropivacaine"
64499|NCT01986751|P1|Participant Flow|Clonidine and Ropivacaine|"A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).
Clonidine
ropivacaine"
64500|NCT01986751|O2|Outcome|Ropivacaine|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64501|NCT01986751|O1|Outcome|Clonidine and Ropivacaine|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64502|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64503|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64504|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64505|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64506|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64577|NCT01985581|O1|Outcome|Placebo and Stimulant|The child's quality of life as assessed by the parent was measured in subjects taking usual stimulant and placebo
64507|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64508|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64509|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64510|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64511|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64512|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64513|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64514|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64515|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
64516|NCT01986751|E2|Reported Event|Ropivacaine (Control)|Standard saphenous nerve block (adductor canal approach) will be performed using 20 ml of 0.5% ropivacaine
64517|NCT01986751|E1|Reported Event|Clonidine and Ropivacaine (Study Group)|A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).
64518|NCT01986361|B3|Baseline|Total|Total of all reporting groups
64519|NCT01986361|B2|Baseline|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64520|NCT01986361|B1|Baseline|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64521|NCT01986361|P2|Participant Flow|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64522|NCT01986361|P1|Participant Flow|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64523|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64524|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64525|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64526|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64527|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64528|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64529|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64530|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64531|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64532|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64533|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64534|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64535|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64536|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64537|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64538|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64539|NCT01986361|O2|Outcome|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64540|NCT01986361|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64541|NCT01986361|E2|Reported Event|Placebo Lozenge|A single placebo lozenge is sucked until fully dissolved.
64542|NCT01986361|E1|Reported Event|Flurbiprofen 8.75 mg Lozenge|A single flurbiprofen lozenge is sucked until fully dissolved.
64543|NCT01986231|B1|Baseline|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.
Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
64544|NCT01986231|P1|Participant Flow|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.
Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
64545|NCT01986231|O1|Outcome|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.
Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
64546|NCT01986231|O1|Outcome|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.
Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
64547|NCT01986231|E1|Reported Event|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.
Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
64548|NCT01986062|B3|Baseline|Total|Total of all reporting groups
64549|NCT01986062|B2|Baseline|Placebo (1 Week) Then AR11 (1 Week) - Double Blind|Placebo, administered orally, BID for one week (crossover to AR11 administration week 2)
64550|NCT01986062|B1|Baseline|AR11 (1 Week) Then Placebo (1 Week) - Double Blind|AR11, administered orally, BID for one week (crossover to placebo administration week 2)
64551|NCT01986062|P2|Participant Flow|Placebo (1 Week) Then AR11 (1 Week) - Double Blind|Placebo, administered orally, BID, for one week (crossover to AR11administration week 2)
64552|NCT01986062|P1|Participant Flow|AR11 (1 Week) Then Placebo (1 Week) - Double Blind|AR11, administered orally, BID, for one week (crossover to placebo administration week 2)
64553|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
64554|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
64555|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
64556|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
64557|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
64558|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
64559|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
64560|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
64561|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
64562|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
64563|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
64564|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
64565|NCT01986062|E2|Reported Event|Placebo|Placebo, administered orally, BID for one week
64566|NCT01986062|E1|Reported Event|AR11|AR11, administered orally, BID for one week
64567|NCT01985581|B3|Baseline|Total|Total of all reporting groups
64568|NCT01985581|B2|Baseline|GXR First Then PLB|subjects received GXR in first arm of study and PLB in second arm subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
64569|NCT01985581|B1|Baseline|PLB First Then GXR|subjects received PLB in first arm of study and GXR in second arm. subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
64570|NCT01985581|P2|Participant Flow|GXR First Then Placebo|patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and GXR for the first intervention period and placebo for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
64571|NCT01985581|P1|Participant Flow|Placebo First Then GXR|patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and placebo for the first intervention period and GXR for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
64572|NCT01985581|O2|Outcome|GXR and Stimulant|subjects who continued to take usual stimulant dosage and took GXR (optimized dose 1-4 mg)
64573|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects who continued to take usual stimulant dosage and took placebo
64574|NCT01985581|O2|Outcome|GXR and Stimulant|subjects who continued to take usual stimulant dosage and took GXR at optimized dose of 1-4 mg
64575|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects who continued to take usual stimulant dosage and took placebo
64578|NCT01985581|O2|Outcome|Stimulant and Guanfancine Extended Release|"patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and also receive guanfacine extended release at a individually optimized dosage of 1-4 mg.
Guanfacine extended release"
64579|NCT01985581|O1|Outcome|Stimulant & Placebo|"patient will continue to take stable dosage of usual stimulant(Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)therapy plus placebo
Placebo"
64580|NCT01985581|O2|Outcome|GXR and Stimulant|Patients continued to take usual dose stimulant and optimized dose (1-4mg) of GXR
64581|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects continued to take usual dose stimulant and took placebo
64582|NCT01985581|O2|Outcome|GXR and Stimulant|The quality of life was measured in those patients taking GXR along with their usual stimulant therapy
64583|NCT01985581|O1|Outcome|Placebo and Stimulant|The quality of life was measured in those patients taking placebo along with their usual stimulant therapy
64584|NCT01985581|O2|Outcome|GXR and Stimulant|Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
64585|NCT01985581|O1|Outcome|Placebo and Stimulant|Subjects received placebo and usual stimulant therapy
64586|NCT01985581|E2|Reported Event|Stimulant and PLB|adverse event frequency in those taking stimulant + PLB
64587|NCT01985581|E1|Reported Event|Stimulant and GXR|adverse event frequency in those taking stimulant + GXR
64588|NCT01985425|B3|Baseline|Total|Total of all reporting groups
64589|NCT01985425|B2|Baseline|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine Placebo"
64646|NCT01984697|B1|Baseline|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64590|NCT01985425|B1|Baseline|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine"
64591|NCT01985425|P2|Participant Flow|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine Placebo"
64592|NCT01985425|P1|Participant Flow|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine"
64593|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine Placebo"
64594|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine"
64595|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine Placebo"
64596|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine"
64597|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine Placebo"
64598|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine"
64599|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine Placebo"
64600|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine"
64601|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine Placebo"
64602|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine"
64635|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64603|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine Placebo"
64604|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine"
64605|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine Placebo"
64606|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine"
64607|NCT01985425|E2|Reported Event|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine Placebo"
64647|NCT01984697|P5|Participant Flow|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64608|NCT01985425|E1|Reported Event|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Colchicine"
64609|NCT01985321|B3|Baseline|Total|Total of all reporting groups
64610|NCT01985321|B2|Baseline|Ethanol|36 applications over a 96 hour period
64611|NCT01985321|B1|Baseline|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period
ethanol/glycolic acid solution: ethanol/glycolic acid solution"
64612|NCT01985321|P2|Participant Flow|Ethanol|36 applications over a 96 hour period
64613|NCT01985321|P1|Participant Flow|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period
ethanol/glycolic acid solution: ethanol/glycolic acid solution"
64614|NCT01985321|O2|Outcome|Ethanol|36 applications over a 96 hour period
64615|NCT01985321|O1|Outcome|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period
ethanol/glycolic acid solution: ethanol/glycolic acid solution"
64616|NCT01985321|O2|Outcome|Ethanol|36 applications over a 96 hour period
64617|NCT01985321|O1|Outcome|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period
ethanol/glycolic acid solution: ethanol/glycolic acid solution"
64618|NCT01985321|E2|Reported Event|Ethanol|36 applications over a 96 hour period
64619|NCT01985321|E1|Reported Event|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period
ethanol/glycolic acid solution: ethanol/glycolic acid solution"
64620|NCT01985126|B3|Baseline|Total|Total of all reporting groups
64621|NCT01985126|B2|Baseline|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64622|NCT01985126|B1|Baseline|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64623|NCT01985126|P2|Participant Flow|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64624|NCT01985126|P1|Participant Flow|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64625|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64626|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64627|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64628|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64629|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64630|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64631|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64632|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64633|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64634|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64637|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64638|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64639|NCT01985126|E2|Reported Event|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64640|NCT01985126|E1|Reported Event|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
64641|NCT01984697|B6|Baseline|Total|Total of all reporting groups
64642|NCT01984697|B5|Baseline|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64643|NCT01984697|B4|Baseline|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64644|NCT01984697|B3|Baseline|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64645|NCT01984697|B2|Baseline|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64648|NCT01984697|P4|Participant Flow|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64649|NCT01984697|P3|Participant Flow|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64650|NCT01984697|P2|Participant Flow|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64651|NCT01984697|P1|Participant Flow|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64652|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64653|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64654|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64655|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64656|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64657|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64658|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64659|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64660|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64661|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64662|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64663|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64664|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64665|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64666|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64667|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64668|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64669|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64670|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64671|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64672|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64673|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64674|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64675|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64676|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64677|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64678|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64679|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64680|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64681|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64682|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64683|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64684|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64685|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64686|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64687|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64688|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64689|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64690|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64691|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64692|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64693|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64694|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64695|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64696|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64697|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64698|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64699|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64700|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64701|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64702|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64703|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64704|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64705|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64706|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64707|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64708|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64709|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64710|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64711|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64712|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64713|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64714|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64715|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64716|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64717|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64718|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64719|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64720|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64721|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
65967|NCT01976299|O2|Outcome|Standard of Care|
64722|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64723|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64724|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64725|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64726|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64727|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64728|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64729|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64730|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64731|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64732|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64733|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64734|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64735|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64736|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64737|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64738|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64739|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64740|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64741|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64742|NCT01984697|E5|Reported Event|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64743|NCT01984697|E4|Reported Event|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
64744|NCT01984697|E3|Reported Event|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
64745|NCT01984697|E2|Reported Event|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64746|NCT01984697|E1|Reported Event|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
64748|NCT01984684|B2|Baseline|Vancomycin Plus Aztreonam|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
vancomycin: 2
aztreonam: 2"
64749|NCT01984684|B1|Baseline|Delafloxacin|"300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
delafloxacin: 1"
64750|NCT01984684|P2|Participant Flow|Vancomycin Plus Aztreonam|"Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
vancomycin: 2
aztreonam: 2"
64751|NCT01984684|P1|Participant Flow|Delafloxacin|"300 mg IV Q12H for 6 doses, 450 mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
delafloxacin: 1"
64752|NCT01984684|O2|Outcome|Vancomycin Plus Aztreonam|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
vancomycin: 2
aztreonam: 2"
64753|NCT01984684|O1|Outcome|Delafloxacin|"300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
delafloxacin: 1"
64754|NCT01984684|O2|Outcome|Vancomycin Plus Aztreonam|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
vancomycin: 2
aztreonam: 2"
64755|NCT01984684|O1|Outcome|Delafloxacin|"300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
delafloxacin: 1"
64756|NCT01984684|O2|Outcome|Vancomycin Plus Aztreonam|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
vancomycin: 2
aztreonam: 2"
64757|NCT01984684|O1|Outcome|Delafloxacin|"300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
delafloxacin: 1"
64758|NCT01984684|E2|Reported Event|Vancomycin Plus Aztreonam|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
vancomycin: 2
aztreonam: 2"
64759|NCT01984684|E1|Reported Event|Delafloxacin|"300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
delafloxacin: 1"
64760|NCT01984515|B1|Baseline|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care
Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
64761|NCT01984515|P1|Participant Flow|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care
Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
64762|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care
Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
64763|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care
Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
64764|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care
Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
64765|NCT01984515|E1|Reported Event|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care
Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
64766|NCT01984294|B4|Baseline|Total|Total of all reporting groups
64767|NCT01984294|B3|Baseline|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
64768|NCT01984294|B2|Baseline|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
64769|NCT01984294|B1|Baseline|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
64770|NCT01984294|P3|Participant Flow|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
64771|NCT01984294|P2|Participant Flow|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
64772|NCT01984294|P1|Participant Flow|LDV/SOF+RBV|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
64773|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
64774|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
64775|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
64776|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
64777|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
64778|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
64779|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
64780|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
90860|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
64781|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
64782|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
64783|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
64784|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
64785|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
64786|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
64787|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
64788|NCT01984294|E3|Reported Event|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
64789|NCT01984294|E2|Reported Event|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
64790|NCT01984294|E1|Reported Event|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
64791|NCT01984229|B3|Baseline|Total|Total of all reporting groups
64792|NCT01984229|B2|Baseline|Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
64793|NCT01984229|B1|Baseline|Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
64794|NCT01984229|P2|Participant Flow|Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
64795|NCT01984229|P1|Participant Flow|Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40 milligrams (mg) single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg twice daily (BID) oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
64796|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64797|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64798|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64799|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
64800|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64801|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64802|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64803|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
64804|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64805|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64806|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64807|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64808|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64809|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64810|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64812|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64813|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64814|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64815|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
64816|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64817|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64818|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64819|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64820|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64821|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64822|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64823|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
64824|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64825|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
64826|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64827|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
64828|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64829|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64830|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64831|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64832|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64833|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64834|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64836|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64837|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
64838|NCT01984229|E6|Reported Event|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64839|NCT01984229|E5|Reported Event|Cohort B: Posaconazole (Period 2)|Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
64840|NCT01984229|E4|Reported Event|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
64841|NCT01984229|E3|Reported Event|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
64842|NCT01984229|E2|Reported Event|Cohort A: Posaconazole (Period 2)|Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
64843|NCT01984229|E1|Reported Event|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
64844|NCT01983878|B1|Baseline|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
64845|NCT01983878|P1|Participant Flow|Ramucirumab 8 mg/kg|Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment continued until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
64846|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
90861|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
64847|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
64848|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
64849|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
64850|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
64851|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
64852|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
64853|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
64854|NCT01983878|E1|Reported Event|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
64855|NCT01983839|B1|Baseline|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
64856|NCT01983839|P1|Participant Flow|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
64857|NCT01983839|O1|Outcome|Pharmacokinetics Moxifloxacin|"Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
The model estimated median values of total Cmax and fAUC0-24 for the current study population were3.99 mg/L (IQR 3.19; 5.29) and 32.78 mg.hr/L (IQR 22.75; 47.31). respectively."
64858|NCT01983839|O1|Outcome|Pharmacokinetics Moxifloxacin|"Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
The model estimated median values of total Cmax and fAUC0-24 for the current study population were3.99 mg/L (IQR 3.19; 5.29) and 32.78 mg.hr/L (IQR 22.75; 47.31). respectively."
64859|NCT01983839|E1|Reported Event|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
64860|NCT01983787|B1|Baseline|Pharmacokinetics Piperacillin|Patients with cystic fibrosis and pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
65526|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
64861|NCT01983787|P1|Participant Flow|Pharmacokinetics Piperacillin|Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
64862|NCT01983787|O9|Outcome|Patient 10|MIC (mg/L) of pathogen detected in sputum: 2 mg/L
64863|NCT01983787|O8|Outcome|Patient 9|MIC (mg/L) of pathogen detected in sputum: 0.75 mg/L
64864|NCT01983787|O7|Outcome|Patient 8|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
64865|NCT01983787|O6|Outcome|Patient 7|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
64866|NCT01983787|O5|Outcome|Patient 6|MIC (mg/L) of pathogen detected in sputum: 0.5 mg/L
64867|NCT01983787|O4|Outcome|Patient 4|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
64868|NCT01983787|O3|Outcome|Patient 3|MIC (mg/L) of pathogen detected in sputum: 16 mg/L
64869|NCT01983787|O2|Outcome|Patient 2|MIC (mg/L) of pathogen detected in sputum: 8 mg/L
64870|NCT01983787|O1|Outcome|Patient 1|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
64871|NCT01983787|O9|Outcome|T>MIC 12g/Day, Patient 10|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
64872|NCT01983787|O8|Outcome|T>MIC 12g/Day, Patient 9|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Acromobacter. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
64915|NCT01983566|E3|Reported Event|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
64873|NCT01983787|O7|Outcome|T>MIC 12g/Day, Patient 8|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
64874|NCT01983787|O6|Outcome|T>MIC 12g/Day, Patient 7|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
64875|NCT01983787|O5|Outcome|T>MIC12g/Day, Patient 6|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
64876|NCT01983787|O4|Outcome|T>MIC 16g/Day, Patient 4|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
64877|NCT01983787|O3|Outcome|T>MIC 16g/Day, Patient 3|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
64878|NCT01983787|O2|Outcome|T>MIC 16g/Day, Patient 2|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
64879|NCT01983787|O1|Outcome|T>MIC 16g/Day, Patient 1|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
64880|NCT01983787|O2|Outcome|Pharmacokinetics Piperacillin 12g/Day|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.
64881|NCT01983787|O1|Outcome|Pharmacokinetics Piperacillin 16g/Day|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks.
64882|NCT01983787|E1|Reported Event|Pharmacokinetics Piperacillin|Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
64883|NCT01982695|B3|Baseline|Total|Total of all reporting groups
64884|NCT01982695|B2|Baseline|Lospartan|Lisinopril
64885|NCT01982695|B1|Baseline|Lisinopril|Lisinopril
64886|NCT01982695|P2|Participant Flow|Losartan|Approximately 0.7 mg/kg/day in oral capsules
64887|NCT01982695|P1|Participant Flow|Lisinopril|Approximately 0.07 mg/kg/day in oral capsules
64888|NCT01982695|O2|Outcome|Losartan|Losartan
64889|NCT01982695|O1|Outcome|Lisinopril|Lisinopril
64890|NCT01982695|E2|Reported Event|Losartan|Losartan
64891|NCT01982695|E1|Reported Event|Lisinopril|Lisinopril
64892|NCT01983566|B5|Baseline|Total|Total of all reporting groups
64893|NCT01983566|B4|Baseline|Dele + OMP / Dele Fasted / Dele Low Fat / Dele High Fat|"Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele fasted, followed by a washout phase, followed by Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele after a standardised high-fat, high-calorie meal.
Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.
The duration of a washout phase was at least 6 days."
64937|NCT01983111|O1|Outcome|Buprenorphine|"Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
64894|NCT01983566|B3|Baseline|Dele Low Fat / Dele + OMP / Dele High Fat / Dele Fasted|"Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele after a standardised high-fat, high-calorie meal, followed by a washout phase, followed by Dele fasted.
Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.
The duration of a washout phase was at least 6 days."
64895|NCT01983566|B2|Baseline|Dele High Fat / Dele Low Fat / Dele Fasted / Dele + OMP|"Dele after a standardised high-fat, high-calorie meal, followed by a washout phase, followed by Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele fasted, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily.
Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.
The duration of a washout phase was at least 6 days."
64896|NCT01983566|B1|Baseline|Dele Fasted / Dele High Fat / Dele + OMP / Dele Low Fat|"Dele fasted, followed by a washout phase, followed by Dele after a standardised high-fat, high- calorie meal, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele after a standardised low-fat meal.
Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.
The duration of a washout phase was at least 6 days."
64914|NCT01983566|E4|Reported Event|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.
All medications were administered oral with 240 mL of water."
65026|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
64897|NCT01983566|P4|Participant Flow|Dele + OMP / Dele Fasted / Dele Low Fat / Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.
All medications were administered oral with 240 mL of water."
64898|NCT01983566|P3|Participant Flow|Dele Low Fat / Dele + OMP / Dele High Fat / Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.
All medications were administered oral with 240 mL of water."
64899|NCT01983566|P2|Participant Flow|Dele High Fat / Dele Low Fat / Dele Fasted / Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily.
All medications were administered oral with 240 mL of water."
64900|NCT01983566|P1|Participant Flow|Dele Fasted / Dele High Fat / Dele + OMP / Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Deleobuvir (Dele) film-coated tablets after an overnight fast of at least 10 hours (h), followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.
All medications were administered oral with 240 mL of water."
64901|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.
All medications were administered oral with 240 mL of water."
64902|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
64903|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
64904|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
64905|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.
All medications were administered oral with 240 mL of water."
64906|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
64907|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
65060|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
64908|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
64909|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.
All medications were administered oral with 240 mL of water."
64910|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
64911|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
64912|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
64913|NCT01983566|E5|Reported Event|OMP Alone|One gastro-resistant hard capsule of Omeprazole (OMP) (40 mg) once daily in the evening for 4 days administered oral with 240 mL of water.
65968|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system
AVERT"
64916|NCT01983566|E2|Reported Event|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
64917|NCT01983566|E1|Reported Event|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.
The tablets were administered oral with 240 mL of water."
64918|NCT01983254|B3|Baseline|Total|Total of all reporting groups
64919|NCT01983254|B2|Baseline|Education Program|"6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program"
64920|NCT01983254|B1|Baseline|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
64921|NCT01983254|P2|Participant Flow|Education Program|"6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program"
64922|NCT01983254|P1|Participant Flow|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
64923|NCT01983254|O2|Outcome|Education Program|"6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program"
64924|NCT01983254|O1|Outcome|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
64925|NCT01983254|O2|Outcome|Education Program|"6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program"
64926|NCT01983254|O1|Outcome|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
64927|NCT01983254|O2|Outcome|Education Program|"6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program"
64928|NCT01983254|O1|Outcome|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
64929|NCT01983254|E2|Reported Event|Education Program|"6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program"
64930|NCT01983254|E1|Reported Event|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
64931|NCT01983111|B3|Baseline|Total|Total of all reporting groups
64932|NCT01983111|B2|Baseline|Tramadol/Acetaminophen|"Oral tablet
tramadol/acetaminophen: Amount of drug ingredients
: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.
Dosage and administration:
Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
64933|NCT01983111|B1|Baseline|Buprenorphine|"Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
64934|NCT01983111|P2|Participant Flow|Tramadol/Acetaminophen|"Oral tablet
tramadol/acetaminophen: Amount of drug ingredients
: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.
Dosage and administration:
Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
64935|NCT01983111|P1|Participant Flow|Buprenorphine|"Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
64936|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet
tramadol/acetaminophen: Amount of drug ingredients
: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.
Dosage and administration:
Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
64938|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet
tramadol/acetaminophen: Amount of drug ingredients
: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.
Dosage and administration:
Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
64939|NCT01983111|O1|Outcome|Buprenorphine|"Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
64940|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet
tramadol/acetaminophen: Amount of drug ingredients
: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.
Dosage and administration:
Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
64941|NCT01983111|O1|Outcome|Buprenorphine|"Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
64942|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet
tramadol/acetaminophen: Amount of drug ingredients
: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.
Dosage and administration:
Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
64943|NCT01983111|O1|Outcome|Buprenorphine|"Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
65024|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65969|NCT01976299|O2|Outcome|Standard of Care|
64944|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet
tramadol/acetaminophen: Amount of drug ingredients
: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.
Dosage and administration:
Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
64945|NCT01983111|O1|Outcome|Buprenorphine|"Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
64946|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet
tramadol/acetaminophen: Amount of drug ingredients
: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.
Dosage and administration:
Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
64947|NCT01983111|O1|Outcome|Buprenorphine|"Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
64948|NCT01983111|E2|Reported Event|Tramadol/Acetaminophen|"Oral tablet
tramadol/acetaminophen: Amount of drug ingredients
: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.
Dosage and administration:
Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets.
Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 65 subjects who administered the comparator(tramadol/acetaminophen) and had at least one time of safety assessment."
64949|NCT01983111|E1|Reported Event|Buprenorphine|"Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days.
Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 69 subjects who administered the study drug(buprenorphine) and had at least one time of safety assessment."
64950|NCT01983020|B5|Baseline|Total|Total of all reporting groups
64951|NCT01983020|B4|Baseline|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
64952|NCT01983020|B3|Baseline|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
Lidocaine
Ketamine"
64953|NCT01983020|B2|Baseline|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.
Lidocaine"
64954|NCT01983020|B1|Baseline|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.
Ketamine"
64955|NCT01983020|P4|Participant Flow|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
64956|NCT01983020|P3|Participant Flow|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
Lidocaine
Ketamine"
64957|NCT01983020|P2|Participant Flow|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.
Lidocaine"
64958|NCT01983020|P1|Participant Flow|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.
Ketamine"
64959|NCT01983020|O4|Outcome|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
64960|NCT01983020|O3|Outcome|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
Lidocaine
Ketamine"
64961|NCT01983020|O2|Outcome|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.
Lidocaine"
64962|NCT01983020|O1|Outcome|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.
Ketamine"
64963|NCT01983020|E4|Reported Event|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
64964|NCT01983020|E3|Reported Event|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
Lidocaine
Ketamine"
64965|NCT01983020|E2|Reported Event|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.
Lidocaine"
64966|NCT01983020|E1|Reported Event|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.
Ketamine"
64967|NCT01982812|B3|Baseline|Total|Total of all reporting groups
64968|NCT01982812|B2|Baseline|Standard AED|"Standard AED regimen
Standard AED: Active comparitor, Standard AED"
64969|NCT01982812|B1|Baseline|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.
Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
64970|NCT01982812|P2|Participant Flow|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion
2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
65061|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
64971|NCT01982812|P1|Participant Flow|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.
Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
64972|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion
2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
64973|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.
Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
64974|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion
2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
64975|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.
Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
64976|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion
2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
64977|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.
Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
64978|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion
2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
64979|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.
Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
64980|NCT01982812|E2|Reported Event|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion
2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
64981|NCT01982812|E1|Reported Event|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.
Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
64982|NCT01982539|B1|Baseline|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
64983|NCT01982539|P1|Participant Flow|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
64984|NCT01982539|O1|Outcome|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to subjects with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
64985|NCT01982539|E1|Reported Event|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
64986|NCT01982435|B3|Baseline|Total|Total of all reporting groups
64987|NCT01982435|B2|Baseline|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
64988|NCT01982435|B1|Baseline|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
64989|NCT01982435|P2|Participant Flow|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
64990|NCT01982435|P1|Participant Flow|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
64991|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
65527|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
64992|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
64993|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
64994|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
65025|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
90862|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
64995|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
64996|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
64997|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
64998|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
64999|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
65000|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
65001|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
65002|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
65003|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
65528|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
65004|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
65005|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
65006|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
65007|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
65008|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
65009|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
65010|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
65011|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
65012|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
65013|NCT01982435|O2|Outcome|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
65014|NCT01982435|O1|Outcome|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
65015|NCT01982435|E2|Reported Event|Group II - Treat-and-Extend|"Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.
Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months."
65529|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
65016|NCT01982435|E1|Reported Event|Group I - Monthly|"Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema."
65017|NCT01982292|B3|Baseline|Total|Total of all reporting groups
65018|NCT01982292|B2|Baseline|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65019|NCT01982292|B1|Baseline|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65020|NCT01982292|P2|Participant Flow|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65021|NCT01982292|P1|Participant Flow|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65022|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65023|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65027|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65028|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65029|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65030|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65031|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65032|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65033|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65034|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65035|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65036|NCT01982292|E2|Reported Event|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65037|NCT01982292|E1|Reported Event|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
65038|NCT01982253|B4|Baseline|Total|Total of all reporting groups
65039|NCT01982253|B3|Baseline|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
65040|NCT01982253|B2|Baseline|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
65041|NCT01982253|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
65042|NCT01982253|P3|Participant Flow|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
65043|NCT01982253|P2|Participant Flow|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
65044|NCT01982253|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
65045|NCT01982253|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
65046|NCT01982253|O2|Outcome|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
65047|NCT01982253|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
65048|NCT01982253|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
65049|NCT01982253|O2|Outcome|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
65050|NCT01982253|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
65051|NCT01982253|E3|Reported Event|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
65052|NCT01982253|E2|Reported Event|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
65053|NCT01982253|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
65054|NCT01981967|B3|Baseline|Total|Total of all reporting groups
65055|NCT01981967|B2|Baseline|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
65056|NCT01981967|B1|Baseline|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
65057|NCT01981967|P2|Participant Flow|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
65058|NCT01981967|P1|Participant Flow|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
65059|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
65062|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
65063|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
65064|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
65065|NCT01981967|E2|Reported Event|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
65066|NCT01981967|E1|Reported Event|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
65067|NCT01981863|B3|Baseline|Total|Total of all reporting groups
65068|NCT01981863|B2|Baseline|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm
Placebo: Placebo administered in same volume as in experimental arm."
65069|NCT01981863|B1|Baseline|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo
Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
65070|NCT01981863|P2|Participant Flow|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm
Placebo: Placebo administered in same volume as in experimental arm."
65071|NCT01981863|P1|Participant Flow|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo
Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
65072|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm
Placebo: Placebo administered in same volume as in experimental arm."
65073|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo
Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
65074|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm
Placebo: Placebo administered in same volume as in experimental arm."
65075|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo
Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
65076|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm
Placebo: Placebo administered in same volume as in experimental arm."
65077|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo
Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
65078|NCT01981863|E2|Reported Event|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm
Placebo: Placebo administered in same volume as in experimental arm.
No adverse events to report."
65079|NCT01981863|E1|Reported Event|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo
Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.
No adverse advents to report."
65080|NCT01981616|B3|Baseline|Total|Total of all reporting groups
65081|NCT01981616|B2|Baseline|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65082|NCT01981616|B1|Baseline|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65083|NCT01981616|P2|Participant Flow|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65084|NCT01981616|P1|Participant Flow|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65085|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65086|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65087|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65088|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65089|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65090|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65091|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65092|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65093|NCT01981616|E2|Reported Event|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65131|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65094|NCT01981616|E1|Reported Event|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
65095|NCT01981473|B4|Baseline|Total|Total of all reporting groups
65096|NCT01981473|B3|Baseline|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65097|NCT01981473|B2|Baseline|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65098|NCT01981473|B1|Baseline|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65099|NCT01981473|P3|Participant Flow|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65100|NCT01981473|P2|Participant Flow|Adalimumab|Participants who had received treatment with Adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65101|NCT01981473|P1|Participant Flow|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65102|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65103|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65104|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65105|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65106|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65107|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65108|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65109|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65110|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65111|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65112|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65113|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65114|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65115|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65116|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65117|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65118|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65119|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65120|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65121|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65122|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65123|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65124|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65125|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65126|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65127|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65128|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65129|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65130|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65132|NCT01981473|O2|Outcome|% AA-|Proportion of participants negative for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
65133|NCT01981473|O1|Outcome|% AA+|Proportion of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
65134|NCT01981473|O2|Outcome|Adalimumab/ Infliximab|Participants who had received treatment with adalimumab or infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65135|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65136|NCT01981473|E3|Reported Event|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65137|NCT01981473|E2|Reported Event|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65138|NCT01981473|E1|Reported Event|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
65139|NCT01981356|B3|Baseline|Total|Total of all reporting groups
65140|NCT01981356|B2|Baseline|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65187|NCT01980940|B7|Baseline|Pt 2: ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
90863|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
65141|NCT01981356|B1|Baseline|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65142|NCT01981356|P2|Participant Flow|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65143|NCT01981356|P1|Participant Flow|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65144|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65145|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65146|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65147|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65148|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65149|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65530|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
65150|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65151|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65152|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65188|NCT01980940|B6|Baseline|Pt 1: Placebo (Deviation)|Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
90864|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
65153|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65154|NCT01981356|O1|Outcome|Inpatient Psychiatry Unit Staff Members|Barriers and facilitators were assessed through interviews of four inpatient psychiatry unit staff (on nursing assistant, one nurse, two psychologists).
65155|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65156|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65157|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65158|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65159|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65160|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65161|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65162|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65210|NCT01980940|O8|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
65531|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
65163|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
65164|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65189|NCT01980940|B5|Baseline|Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
65165|NCT01981356|E2|Reported Event|Treatment as Usual (TAU)|"TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
Treatment as Usual (TAU): All patients admitted to the acute psychiatry unit are administered anti-psychotic and/or other psychotropic medication during their inpatient stay. Patients participate in standard milieu therapy on the unit (group and activities therapies, and individual therapy as needed). Therapy on the unit focuses on psycho-education about illness, symptom identification, mood management techniques, stress reduction, and relapse prevention. Patients also receive unstructured individual therapy and case management as appropriate."
65166|NCT01981356|E1|Reported Event|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
65167|NCT01981057|B3|Baseline|Total|Total of all reporting groups
65168|NCT01981057|B2|Baseline|Individual|"individually prescribed parenteral receipt
Numeta: parenteral receipt prescribed with Numeta
Individual: parenteral receipt prescribed individually"
65169|NCT01981057|B1|Baseline|Numeta|"parenteral receipt prescribed with Numeta
Numeta: parenteral receipt prescribed with Numeta
Individual: parenteral receipt prescribed individually"
65170|NCT01981057|P2|Participant Flow|Individual|"individually prescribed parenteral receipt
Numeta: parenteral receipt prescribed with Numeta
Individual: parenteral receipt prescribed individually"
65171|NCT01981057|P1|Participant Flow|Numeta|"parenteral receipt prescribed with Numeta
Numeta: parenteral receipt prescribed with Numeta
Individual: parenteral receipt prescribed individually"
65172|NCT01981057|O2|Outcome|Individual|"individually prescribed parenteral receipt
Numeta: parenteral receipt prescribed with Numeta
Individual: parenteral receipt prescribed individually"
65173|NCT01981057|O1|Outcome|Numeta|"parenteral receipt prescribed with Numeta
Numeta: parenteral receipt prescribed with Numeta
Individual: parenteral receipt prescribed individually"
65174|NCT01981057|E2|Reported Event|Individual|"individually prescribed parenteral receipt
Numeta: parenteral receipt prescribed with Numeta
Individual: parenteral receipt prescribed individually"
65175|NCT01981057|E1|Reported Event|Numeta|"parenteral receipt prescribed with Numeta
Numeta: parenteral receipt prescribed with Numeta
Individual: parenteral receipt prescribed individually"
65176|NCT01980992|B3|Baseline|Total|Total of all reporting groups
65177|NCT01980992|B2|Baseline|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
65178|NCT01980992|B1|Baseline|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
65179|NCT01980992|P2|Participant Flow|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
65180|NCT01980992|P1|Participant Flow|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
65181|NCT01980992|O2|Outcome|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
65182|NCT01980992|O1|Outcome|Placebo|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a week 52 7443mg wheat protein oral food challenge (OFC).
65211|NCT01980940|O7|Outcome|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
65532|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
65183|NCT01980992|E2|Reported Event|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
65184|NCT01980992|E1|Reported Event|Placebo|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
65185|NCT01980940|B9|Baseline|Total|Total of all reporting groups
65186|NCT01980940|B8|Baseline|Pt 2: Placebo|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
65970|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system
AVERT"
65190|NCT01980940|B4|Baseline|Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
65191|NCT01980940|B3|Baseline|Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
65192|NCT01980940|B2|Baseline|Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
65193|NCT01980940|B1|Baseline|Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
65194|NCT01980940|P8|Participant Flow|Pt 2: Placebo|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
65195|NCT01980940|P7|Participant Flow|Pt 2: ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
65196|NCT01980940|P6|Participant Flow|Pt 1: Placebo (Deviation)|Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
65197|NCT01980940|P5|Participant Flow|Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
65198|NCT01980940|P4|Participant Flow|Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
65199|NCT01980940|P3|Participant Flow|Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
65200|NCT01980940|P2|Participant Flow|Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
65201|NCT01980940|P1|Participant Flow|Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
65202|NCT01980940|O8|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
65203|NCT01980940|O7|Outcome|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
65204|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
65205|NCT01980940|O5|Outcome|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
65206|NCT01980940|O4|Outcome|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
65207|NCT01980940|O3|Outcome|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
65208|NCT01980940|O2|Outcome|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
65209|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
65212|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
65213|NCT01980940|O5|Outcome|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
65214|NCT01980940|O4|Outcome|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
65215|NCT01980940|O3|Outcome|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
65216|NCT01980940|O2|Outcome|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
65217|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
65218|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
65219|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
65220|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
65221|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
65222|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
65223|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
65224|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
65225|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
65226|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
65227|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
65228|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
65229|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
65230|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
65231|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
65232|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
65233|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
65234|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
65235|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
65236|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
65237|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
65238|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
65239|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
65240|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
65241|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
65242|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
65243|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
65244|NCT01980940|E8|Reported Event|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
65245|NCT01980940|E7|Reported Event|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
65246|NCT01980940|E6|Reported Event|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
65247|NCT01980940|E5|Reported Event|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
65248|NCT01980940|E4|Reported Event|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
65249|NCT01980940|E3|Reported Event|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
65250|NCT01980940|E2|Reported Event|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
65251|NCT01980940|E1|Reported Event|ETOR 75 DMSO (Pt 1)|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
65252|NCT01980875|B4|Baseline|Total|Total of all reporting groups
65253|NCT01980875|B3|Baseline|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65254|NCT01980875|B2|Baseline|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65255|NCT01980875|B1|Baseline|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65256|NCT01980875|P3|Participant Flow|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65257|NCT01980875|P2|Participant Flow|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65258|NCT01980875|P1|Participant Flow|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib (Zydelig®) 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65259|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65260|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65261|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65262|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65263|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65264|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65265|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65266|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65267|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65268|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65269|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65270|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65271|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65272|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65273|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65274|NCT01980875|O3|Outcome|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65275|NCT01980875|O2|Outcome|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65276|NCT01980875|O1|Outcome|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65277|NCT01980875|E3|Reported Event|Randomized: Obinutuzumab+Chlorambucil|Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65278|NCT01980875|E2|Reported Event|Randomized: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65279|NCT01980875|E1|Reported Event|Safety Run-In: Idelalisib+Obinutuzumab|Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
65280|NCT01980628|B1|Baseline|Ibrutinib|Patients receive a daily dose of 560 mg of ibrutinib capsules
65281|NCT01980628|P1|Participant Flow|Ibrutinib|Patients receive daily dose of 560 mg of ibrutinib capsules.
65282|NCT01980628|O1|Outcome|Ibrutinib|Patients receive daily dose of 560 mg of ibrutinib capsules.
65283|NCT01980628|O1|Outcome|Single Arm, Intent to Treat Population|
65284|NCT01980628|E1|Reported Event|Ibrutinib|"ibrutinib capsules: 560 mg once daily
ibrutinib"
65285|NCT01980589|B4|Baseline|Total|Total of all reporting groups
65286|NCT01980589|B3|Baseline|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65287|NCT01980589|B2|Baseline|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65288|NCT01980589|B1|Baseline|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65289|NCT01980589|P3|Participant Flow|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65290|NCT01980589|P2|Participant Flow|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65291|NCT01980589|P1|Participant Flow|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65292|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65293|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65848|NCT01976663|B1|Baseline|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
65294|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65295|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65296|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65297|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65298|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65299|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65300|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65301|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65302|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65303|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65304|NCT01980589|E3|Reported Event|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65392|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
65393|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
65305|NCT01980589|E2|Reported Event|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65306|NCT01980589|E1|Reported Event|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
65307|NCT01980524|B1|Baseline|All Study Participants|On study day 1 subjects received acipimox 250 mg or placebo at 0 and 180 minutes (randomized, controlled, single blinded); after a wash out period of at least two weeks on study day 2 i) subjects who received acipimox 250 mg on study day 1 were administered placebo at 0 and 180 minutes and ii) subjects who received placebo on study day 1 were administered acipimox 250 mg at 0 and 180 minutes (randomized, controlled, single blinded).
65308|NCT01980524|P2|Participant Flow|Placebo|Participants received a placebo capsule at 0 and 180 minutes on the first study day; after a wash out period of at least 2 weeks a second study day followed where they received a acipimox 250 mg at 0 and 180 minutes
65849|NCT01976663|P1|Participant Flow|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
65971|NCT01976299|O2|Outcome|Standard of Care|
65309|NCT01980524|P1|Participant Flow|Acipimox First|Participants received acipimox 250 mg at 0 and 180 minutes on the first study day; after a wash out period of at least 2 weeks a second study day followed where they received a placebo capsule at 0 and 180 minutes
65310|NCT01980524|O2|Outcome|Placebo|"1 capsule at 0 and 180 minutes (one day)
placebo"
65311|NCT01980524|O1|Outcome|Acipimox+|"250 mg at 0 and 180 minutes (one day)
acipimox"
65312|NCT01980524|O2|Outcome|Placebo|"1 capsule at 0 and 180 minutes (one day)
placebo"
65313|NCT01980524|O1|Outcome|Acipimox+|"250 mg at 0 and 180 minutes (one day)
acipimox"
65314|NCT01980524|O2|Outcome|Placebo|"1 capsule at 0 and 180 minutes (one day)
placebo"
65315|NCT01980524|O1|Outcome|Acipimox+|"250 mg at 0 and 180 minutes (one day)
acipimox"
65316|NCT01980524|E2|Reported Event|Acipimox-|"1 Tablet at 0 and 180 minutes (one day)
acipimox"
65317|NCT01980524|E1|Reported Event|Acipimox+|"250 mg at 0 and 180 minutes (one day)
acipimox"
65318|NCT01980095|B3|Baseline|Total|Total of all reporting groups
65319|NCT01980095|B2|Baseline|Placebo|Capsules that look like the RHB-105 product but contain no active ingredient.
65320|NCT01980095|B1|Baseline|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.
Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg."
65321|NCT01980095|P2|Participant Flow|Placebo|Capsules that look like the RHB-105 product but contain no active ingredient.
65322|NCT01980095|P1|Participant Flow|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.
Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg"
65323|NCT01980095|O2|Outcome|Active Drug Eradication Failure Subjects|These patients failed h.pylori eradication on study drug (active) and were subsequently treated with standard of care therapy as per the investigator.
65324|NCT01980095|O1|Outcome|Placebo Subjects|These patients failed h.pylori eradication on study drug (placebo) and were subsequently treated with standard of care therapy as per the investigator
65325|NCT01980095|O2|Outcome|Placebo|"Capsules that look like the RHB-105 product but contain no active ingredient.
Placebo: Subjects will take 4 placebo capsules every 8 hours with food for 14 days."
65326|NCT01980095|O1|Outcome|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.
Total daily dose of:
Rifabutin 150 mg
Amoxicillin 3000 mg
Omeprazole 120 mg"
65327|NCT01980095|E2|Reported Event|Placebo|Identical capsules that look like the RHB-105 product but contain no active ingredient.
65328|NCT01980095|E1|Reported Event|RHB-105|RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg.
65329|NCT01979185|B3|Baseline|Total|Total of all reporting groups
65330|NCT01979185|B2|Baseline|Simvastatin + SSP-004184SS First|Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
65331|NCT01979185|B1|Baseline|Simvastatin First|Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
65332|NCT01979185|P2|Participant Flow|Simvastatin + SSP-004184SS First|Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
65333|NCT01979185|P1|Participant Flow|Simvastatin First|Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
65334|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
65335|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
65336|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
65337|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
65338|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
65339|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
65340|NCT01979185|E2|Reported Event|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
65341|NCT01979185|E1|Reported Event|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
65394|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
65395|NCT01978600|E2|Reported Event|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
65533|NCT01977612|E2|Reported Event|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
65342|NCT01979133|B1|Baseline|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.
Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
65397|NCT01978145|B1|Baseline|Overall Study|All participants received one of the following 2 treatments in each of the two 12-week treatment periods separated by a 4-week washout period. One inhalation of FSC (250/50 mcg) self administered twice daily (BID) (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI or one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI . Salbutamol/albuterol was provided to use as rescue medication.
65850|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
65343|NCT01979133|P1|Participant Flow|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.
Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
65344|NCT01979133|O2|Outcome|Week 8|Week 8 YMRS Score
65345|NCT01979133|O1|Outcome|Baseline|Baseline YMRS Score
65346|NCT01979133|O2|Outcome|Week 8|Week 8 Days of alcohol use per week
65347|NCT01979133|O1|Outcome|Baseline|Baseline Days of alcohol use per week
65348|NCT01979133|O2|Outcome|Week 8|Week 8 Heavy Drinking Days Per Week
65349|NCT01979133|O1|Outcome|Baseline|Baseline Heavy Drinking Days Per Week
65350|NCT01979133|O2|Outcome|Week 8|Week 8 Mean Standard Drinks Per Week
65351|NCT01979133|O1|Outcome|Baseline|Baseline Mean Standard Drinks Per Week
65352|NCT01979133|O2|Outcome|Week 8|Week 8 QIDS Score
65353|NCT01979133|O1|Outcome|Baseline|Baseline QIDS Score
65354|NCT01979133|O2|Outcome|Week 8|Week 8 HAMA Score
65355|NCT01979133|O1|Outcome|Baseline|Baseline HAMA Score
65356|NCT01979133|O2|Outcome|Week 8|Week 8 HAMD Score
65357|NCT01979133|O1|Outcome|Baseline|Baseline HAMD Score
65358|NCT01979133|E1|Reported Event|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.
Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
65359|NCT01979029|B3|Baseline|Total|Total of all reporting groups
65360|NCT01979029|B2|Baseline|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.
preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
65361|NCT01979029|B1|Baseline|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.
not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
65362|NCT01979029|P2|Participant Flow|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.
preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
65363|NCT01979029|P1|Participant Flow|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.
not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
65364|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.
preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
65365|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.
not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
65398|NCT01978145|P2|Participant Flow|Sequence 2: FSC MD DPI/Pl CB DPI Then Pl MD DPI/FSC CB DPI|Participants self administered one inhalation of FSC (250/50 mcg) via a MD DPI and one inhalation of Placebo via a CB DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 4 weeks, participants self admnistered one inhalation of matching Placebo via a MD DPI and one inhalation of FSC (250/50 mcg) via a CB DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65366|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.
preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
65367|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.
not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
65368|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.
preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
65369|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.
not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
65370|NCT01979029|E2|Reported Event|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.
preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
65371|NCT01979029|E1|Reported Event|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.
not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
65372|NCT01978743|B1|Baseline|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
65373|NCT01978743|P1|Participant Flow|Raltegravir|"All participants are switched from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + truvada (FTC/TDF).
Raltegravir will be administered 400mg twice-a-day."
65374|NCT01978743|O1|Outcome|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
65375|NCT01978743|O1|Outcome|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
65376|NCT01978743|O1|Outcome|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
65377|NCT01978743|O1|Outcome|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
65378|NCT01978743|O1|Outcome|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
65379|NCT01978743|O1|Outcome|Raltegravir|"Switch from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + Truvada (FTC/TDF). Raltegravir will be administered 400mg twice-a-day with Truvada for 8 weeks.
Drug switch from Atripla: Switch from Atripla to Raltegravir 400mg BID + Truvada (FTC/TDF) for total of 8 weeks"
65380|NCT01978743|O1|Outcome|Raltegravir|"Switch from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + Truvada (FTC/TDF). Raltegravir will be administered 400mg twice-a-day with Truvada for 8 weeks.
Drug switch from Atripla: Switch from Atripla to Raltegravir 400mg BID + Truvada (FTC/TDF) for total of 8 weeks"
65381|NCT01978743|O1|Outcome|Raltegravir|"Switch from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + Truvada (FTC/TDF). Raltegravir will be administered 400mg twice-a-day with Truvada for 8 weeks.
Drug switch from Atripla: Switch from Atripla to Raltegravir 400mg BID + Truvada (FTC/TDF) for total of 8 weeks"
65382|NCT01978743|O1|Outcome|Raltegravir|"Switch from Atripla (EFV/FTC/TDF) to raltegravir (RAL) + Truvada (FTC/TDF). Raltegravir will be administered 400mg twice-a-day with Truvada for 8 weeks.
Drug switch from Atripla: Switch from Atripla to Raltegravir 400mg BID + Truvada (FTC/TDF) for total of 8 weeks"
65383|NCT01978743|E1|Reported Event|Raltegravir|All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
65384|NCT01978600|B3|Baseline|Total|Total of all reporting groups
65385|NCT01978600|B2|Baseline|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
65386|NCT01978600|B1|Baseline|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
65387|NCT01978600|P2|Participant Flow|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
65388|NCT01978600|P1|Participant Flow|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
65389|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
65390|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
65391|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
65613|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
90865|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
65399|NCT01978145|P1|Participant Flow|Sequence 1: Pl MD DPI/FSC CB DPI Then FSC MD DPI/Pl CB DPI|Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) followed by one inhalation of single capsule containing Fluticasone propionate and salmeterol combination (FSC) (250/50 microgram [mcg]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 4 weeks, participants self administered one inhalation of FSC (250/50 mcg) via the MD DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication
65400|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65401|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65402|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65403|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65404|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65405|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65406|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65407|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65408|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65409|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65410|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65411|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65412|NCT01978145|E2|Reported Event|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65413|NCT01978145|E1|Reported Event|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
65414|NCT01978119|B1|Baseline|Overall Study|All participants received one of the following 2 treatments in each of the two 12-week treatment periods separated by a 3-week washout period. One actuations of FSC (250/50 mcg) self administered twice daily (BID) (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI or one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI. Salbutamol/albuterol was provided to use as rescue medication.
65851|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
65415|NCT01978119|P2|Participant Flow|Sequence 2: FSC MD-DPI/Pl CB-DPI Then Pl MD-DPI/FSC CB-DPI|Participants self administered one inhalation of FSC (250/50 mcg) via a multi-dose DPI and one inhalation of Placebo via a capsule-based unit dose DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self admnistered one inhalation of matching Placebo via a multi-dose DPI and one inhalation of FSC (250/50 mcg) via a capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65416|NCT01978119|P1|Participant Flow|Sequence 1: Pl MD-DPI/FSC CB-DPI Then FSC MD-DPI/Pl CB-DPI|Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) and one inhalation of single capsule containing Fluticasone salmeterol combination (FSC) (250/50 microgram [mcg]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self administered one inhalation of FSC (250/50 mcg) via the multi-dose DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65417|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65418|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65419|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65420|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65421|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65422|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65423|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65424|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65425|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65426|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65427|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65534|NCT01977612|E1|Reported Event|Stainless Steel Staples|Skin closure using stainless steel staples.
65428|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65429|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65852|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
65853|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
65430|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65431|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65432|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65433|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65434|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65435|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65436|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65437|NCT01978119|E2|Reported Event|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65438|NCT01978119|E1|Reported Event|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
65439|NCT01977820|B3|Baseline|Total|Total of all reporting groups
65440|NCT01977820|B2|Baseline|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
65441|NCT01977820|B1|Baseline|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
65442|NCT01977820|P2|Participant Flow|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
65443|NCT01977820|P1|Participant Flow|Sapropterin|Subject was administered with 20 milligram per kilogram (mg/kg) sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
65444|NCT01977820|O2|Outcome|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject completed the study according to the study protocol until the study was terminated by the Sponsor.
65535|NCT01977573|B5|Baseline|Total|Total of all reporting groups
65942|NCT01976312|P1|Participant Flow|Ranibizumab 0.5 mg|PRN intravitreal injection
65445|NCT01977820|O1|Outcome|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject completed the study according to the study protocol until the study was terminated by the Sponsor.
65446|NCT01977820|E2|Reported Event|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
65447|NCT01977820|E1|Reported Event|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
65448|NCT01977794|B3|Baseline|Total|Total of all reporting groups
65449|NCT01977794|B2|Baseline|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65450|NCT01977794|B1|Baseline|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65451|NCT01977794|P2|Participant Flow|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP = SBP <140 mmHg and DBP <90 mmHg.
65452|NCT01977794|P1|Participant Flow|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 milligram (mg) before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine fixed dose combination(FDC) tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at initial dose of 5mg/5mg once daily for 6 weeks.If blood pressure (BP) was controlled at Week 6(Day 43),same dose continued for next 6 weeks. If BP was not controlled at Day 43,dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks.Subjects who had controlled BP atWeek 12(Day 85),continued same dose that they were receiving for next 6 weeks. If BP was not controlled at Day 85,dose was increased to next level,(Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18(Day 127).Controlled BP=Systolic BP(SBP)<140 millimetre of mercury(mmHg) and Diastolic BP(DBP)<90mmHg.
65453|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65454|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65678|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65473|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Tacrolimus"
65854|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
65855|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
65455|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65456|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65457|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65458|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65459|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65460|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65461|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65472|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Methylprednisolone Sodium Succinate"
65462|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65463|NCT01977794|E2|Reported Event|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65464|NCT01977794|E1|Reported Event|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
65465|NCT01977781|B3|Baseline|Total|Total of all reporting groups
65466|NCT01977781|B2|Baseline|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Methylprednisolone Sodium Succinate"
65467|NCT01977781|B1|Baseline|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Tacrolimus"
65468|NCT01977781|P2|Participant Flow|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Methylprednisolone Sodium Succinate"
65469|NCT01977781|P1|Participant Flow|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Tacrolimus"
65470|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Methylprednisolone Sodium Succinate"
65471|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Tacrolimus"
65517|NCT01977612|P2|Participant Flow|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
65518|NCT01977612|P1|Participant Flow|Stainless Steel Staples|Skin closure using stainless steel staples.
65519|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
65520|NCT01977612|O1|Outcome|Stainless Steel Staples|Skin closure using stainless steel staples.
65474|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Methylprednisolone Sodium Succinate"
65475|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Tacrolimus"
65476|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Methylprednisolone Sodium Succinate"
65477|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Tacrolimus"
65478|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Methylprednisolone Sodium Succinate"
65479|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Tacrolimus"
65480|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Methylprednisolone Sodium Succinate"
65481|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Tacrolimus"
65482|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Methylprednisolone Sodium Succinate"
65483|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Tacrolimus"
65521|NCT01977612|O2|Outcome|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
65484|NCT01977781|E2|Reported Event|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Methylprednisolone Sodium Succinate"
65485|NCT01977781|E1|Reported Event|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
Tacrolimus"
65486|NCT01977729|B1|Baseline|All Study Participants|
65487|NCT01977729|P1|Participant Flow|All Participants|Only one participant was recruited, but never randomized.
65488|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
65489|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
65490|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
65491|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
65492|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
65493|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
65494|NCT01977729|E2|Reported Event|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
65495|NCT01977729|E1|Reported Event|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
65496|NCT01977690|B3|Baseline|Total|Total of all reporting groups
65497|NCT01977690|B2|Baseline|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.
Clavicle Brace"
65498|NCT01977690|B1|Baseline|Standard Management|Every patient routinely received narcotic and non-narcotic pain medication on an as-needed basis in the hospital. No nonsteroidal anti-inflammatory drugs, such as ibuprofen or ketorolac, were given.
65499|NCT01977690|P2|Participant Flow|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.
Clavicle Brace"
65500|NCT01977690|P1|Participant Flow|Standard Management|Patients received analgesics ad libitum
65501|NCT01977690|O2|Outcome|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.
Clavicle Brace"
65502|NCT01977690|O1|Outcome|Standard Management|Patients received analgesics ad libitum
65503|NCT01977690|E2|Reported Event|Clavicle Brace Wearing|"Patient has to wear clavicle brace for one month.
Clavicle Brace"
65504|NCT01977690|E1|Reported Event|Standard Management|Patients received analgesic ad libitum
65505|NCT01977625|B1|Baseline|All Participants|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
65506|NCT01977625|P2|Participant Flow|Placebo, Then Lisdexamfetamine|Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks..
65507|NCT01977625|P1|Participant Flow|Lisdexamfetamine, Then Placebo|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
65508|NCT01977625|O2|Outcome|Placebo|14 participants completed all 3 scans.
65509|NCT01977625|O1|Outcome|Lisdexamfetamine|14 participants completed all 3 scans.
65510|NCT01977625|O2|Outcome|Placebo|"Placebo pill, capsules
Placebo: To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women."
65511|NCT01977625|O1|Outcome|Lisdexamfetamine|"Lisdexamfetamine or Vyvanse
Lisdexamfetamine: The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women."
65512|NCT01977625|E2|Reported Event|Placebo|Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks.
65513|NCT01977625|E1|Reported Event|Lisdexamfetamine|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
65514|NCT01977612|B3|Baseline|Total|Total of all reporting groups
65515|NCT01977612|B2|Baseline|4-0 Monofilament Sutures|Skin closure using 4-0 monofilament sutures
65516|NCT01977612|B1|Baseline|Stainless Steel Staples|Skin closure using stainless steel staples.
65536|NCT01977573|B4|Baseline|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65593|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65537|NCT01977573|B3|Baseline|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65538|NCT01977573|B2|Baseline|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65539|NCT01977573|B1|Baseline|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65540|NCT01977573|P4|Participant Flow|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65541|NCT01977573|P3|Participant Flow|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65542|NCT01977573|P2|Participant Flow|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65543|NCT01977573|P1|Participant Flow|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65544|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65545|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65546|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65547|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65548|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65549|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65550|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65551|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65552|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65553|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65573|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65594|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
90866|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
65554|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65555|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65556|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65557|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65558|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65559|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65560|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65561|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65562|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65563|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65564|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65565|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65566|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65567|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65568|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65569|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65570|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65571|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65572|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65574|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65575|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65576|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65577|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65578|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65579|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65580|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65581|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65582|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65583|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65584|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65585|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65586|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65587|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65588|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65589|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65590|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65591|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65592|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65595|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65596|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65597|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65598|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65599|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65600|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65601|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65602|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65603|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65604|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65605|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65606|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65607|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65608|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65609|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65610|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65611|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65650|NCT01977482|B7|Baseline|Total|Total of all reporting groups
65612|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65653|NCT01977482|B4|Baseline|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65614|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65615|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65616|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65617|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65618|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65619|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65620|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65621|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65622|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65623|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65624|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65625|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65626|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65627|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65628|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65629|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65630|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65943|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
65631|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65652|NCT01977482|B5|Baseline|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65632|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65633|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65634|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65635|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65636|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65637|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65638|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65639|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65640|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65641|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65642|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65643|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65644|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65645|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65646|NCT01977573|E4|Reported Event|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
65647|NCT01977573|E3|Reported Event|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
65648|NCT01977573|E2|Reported Event|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
65649|NCT01977573|E1|Reported Event|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
65651|NCT01977482|B6|Baseline|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65856|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
92413|NCT01828112|B3|Baseline|Total|Total of all reporting groups
65654|NCT01977482|B3|Baseline|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65655|NCT01977482|B2|Baseline|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65656|NCT01977482|B1|Baseline|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65657|NCT01977482|P6|Participant Flow|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65658|NCT01977482|P5|Participant Flow|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65659|NCT01977482|P4|Participant Flow|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65660|NCT01977482|P3|Participant Flow|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65661|NCT01977482|P2|Participant Flow|GSK1278863 4 mg|Participants received GSK1278863 4 milligrams (mg) once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65662|NCT01977482|P1|Participant Flow|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65663|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65664|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65665|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65666|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65667|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65668|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65669|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65670|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65671|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65672|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65673|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65674|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65675|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65676|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65677|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65881|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
65679|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65680|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65681|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65682|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65683|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65684|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65685|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65686|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65687|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65688|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65689|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65690|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65691|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65692|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65693|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65694|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65695|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65696|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65697|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65698|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65699|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65700|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65701|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65702|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65703|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65704|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65705|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65706|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65707|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65708|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65709|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65710|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65711|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65712|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65713|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65714|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65715|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65716|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65717|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65718|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65719|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65720|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65721|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65722|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65723|NCT01977482|O5|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65724|NCT01977482|O4|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65725|NCT01977482|O3|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65726|NCT01977482|O2|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65727|NCT01977482|O1|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65728|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65729|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65730|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65731|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65732|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65733|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65734|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65735|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65736|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65737|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65738|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65739|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65740|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65741|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65742|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65743|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65744|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65745|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65746|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65747|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65748|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65749|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65750|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65751|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65752|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65753|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65754|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65755|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65756|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65757|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65758|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65759|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65760|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65761|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65762|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65763|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65764|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65765|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65766|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65767|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65768|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65769|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65770|NCT01977482|E6|Reported Event|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65771|NCT01977482|E5|Reported Event|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65772|NCT01977482|E4|Reported Event|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65773|NCT01977482|E3|Reported Event|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65774|NCT01977482|E2|Reported Event|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65775|NCT01977482|E1|Reported Event|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
65776|NCT01977456|B1|Baseline|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.
Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
65777|NCT01977456|P1|Participant Flow|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.
Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
65778|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.
Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
65779|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.
Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
65780|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.
Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
65781|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.
Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
65782|NCT01977456|E1|Reported Event|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.
Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
65783|NCT01976988|B3|Baseline|Total|Total of all reporting groups
65784|NCT01976988|B2|Baseline|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
65785|NCT01976988|B1|Baseline|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
65844|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months
Aspirin
Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
65857|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
65786|NCT01976988|P2|Participant Flow|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
65787|NCT01976988|P1|Participant Flow|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
65788|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
65789|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
65790|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
65791|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
65792|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
65793|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
65794|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
65795|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
65796|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
65797|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
65798|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
65799|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
65800|NCT01976988|E2|Reported Event|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
65801|NCT01976988|E1|Reported Event|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course
Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
65944|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
65845|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months
Aspirin
Docosahexaenoic acid"
65846|NCT01976806|E2|Reported Event|Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)|
65847|NCT01976806|E1|Reported Event|DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)|
65802|NCT01976871|B1|Baseline|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.
Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
65803|NCT01976871|P1|Participant Flow|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.
Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
65804|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.
Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
65805|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.
Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
65806|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.
Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
65807|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.
Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
65808|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.
Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
65809|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.
Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
65941|NCT01976312|P2|Participant Flow|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
65810|NCT01976871|E1|Reported Event|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.
Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
65811|NCT01976845|B4|Baseline|Total|Total of all reporting groups
65812|NCT01976845|B3|Baseline|Saline|"Saline 2 ml
Saline: Saline 2 ml IV, in the pre-op area as a premedication"
65813|NCT01976845|B2|Baseline|Midazolam|"Midazolam 2 mg IV (2 ml)
Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
65814|NCT01976845|B1|Baseline|Propofol|"Propofol 20 mg IV (2 ml)
Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
65815|NCT01976845|P3|Participant Flow|Saline|"Saline 2 ml
Saline: Saline 2 ml IV, in the pre-op area as a premedication"
65816|NCT01976845|P2|Participant Flow|Midazolam|"Midazolam 2 mg IV (2 ml)
Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
65817|NCT01976845|P1|Participant Flow|Propofol|"Propofol 20 mg IV (2 ml)
Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
65818|NCT01976845|O3|Outcome|Saline|"Saline 2 ml
Saline: Saline 2 ml IV, in the pre-op area as a premedication"
65819|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)
Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
65820|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)
Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
65821|NCT01976845|O3|Outcome|Saline|"Saline 2 ml
Saline: Saline 2 ml IV, in the pre-op area as a premedication"
65822|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)
Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
65823|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)
Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
65824|NCT01976845|O3|Outcome|Saline|"Saline 2 ml
Saline: Saline 2 ml IV, in the pre-op area as a premedication"
65825|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)
Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
65826|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)
Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
65827|NCT01976845|E3|Reported Event|Saline|"Saline 2 ml
Saline: Saline 2 ml IV, in the pre-op area as a premedication"
65828|NCT01976845|E2|Reported Event|Midazolam|"Midazolam 2 mg IV (2 ml)
Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
65829|NCT01976845|E1|Reported Event|Propofol|"Propofol 20 mg IV (2 ml)
Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
65830|NCT01976819|B1|Baseline|TW Speaking Valve/HME|"Use of the TW speaking valve/HME
TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve"
65831|NCT01976819|P1|Participant Flow|TW Speaking Valve/HME|"At baseline, participants were asked to complete a baseline questionnaire. After that, patients were asked to use both the current (old) TW15 or the TW22 for a week. After each week, patients completed a device specific questionnaire. At the end of the two week period, patients also completed a structured and comparative questionnaire.
Patients were then asked to use the new updated Speaking Valve for a week and then to complete relevant sections of the same questionnaire that was also used for the previous (old) device. Patients could decide again whether they wanted to participate in the long term part of the study, which will follow the same structure with the same questionnaires as in Stage 0."
65832|NCT01976819|O2|Outcome|Use of Old Speaking Valve|Data from TW15 and 22 combined.
65833|NCT01976819|O1|Outcome|Use of Updated Speaking Valve|"Use of the TW speaking valve/HME
TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and 22 are combined."
65834|NCT01976819|O2|Outcome|Use of Old Speaking Valve|Usage of the old speaking valve device. TW15 and TW22 combined.
65835|NCT01976819|O1|Outcome|Use of Updated Speaking Valve|"Use of the TW speaking valve/HME
TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and 22 combined."
65836|NCT01976819|O2|Outcome|Use of the Old HME Speaking Valve|Data from the use of the old HME speaking valve, data from TW15 and TW22 combined.
65837|NCT01976819|O1|Outcome|Updated Speaking Valve/HME|"Use of the updated speaking valve/HME
TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and 22 combined."
65838|NCT01976819|E1|Reported Event|TW Speaking Valve/HME|"Use of the TW speaking valve/HME
TW speaking valve/HME: The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve"
65839|NCT01976806|B3|Baseline|Total|Total of all reporting groups
65840|NCT01976806|B2|Baseline|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months
Aspirin
Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
65841|NCT01976806|B1|Baseline|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months
Aspirin
Docosahexaenoic acid"
65842|NCT01976806|P2|Participant Flow|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months
Aspirin
Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
65843|NCT01976806|P1|Participant Flow|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months
Aspirin
Docosahexaenoic acid"
65858|NCT01976663|E4|Reported Event|JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment|Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Asymmetry Correction/Repeat Treatment period.
65859|NCT01976663|E3|Reported Event|Not at NLF During Initial/Touch Up Treatment Period|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
65860|NCT01976663|E2|Reported Event|Control During Initial/Touch Up Treatment Period|Nasolabial folds treated with Control during the Initial/Touch Up period.
65861|NCT01976663|E1|Reported Event|JUVEDERM VOLIFT® XC During Initial/Touch Up|Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Initial/Touch Up period.
65862|NCT01976650|B1|Baseline|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
65863|NCT01976650|P1|Participant Flow|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
65864|NCT01976650|O1|Outcome|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
65865|NCT01976650|O1|Outcome|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
65866|NCT01976650|E1|Reported Event|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
65867|NCT01976624|B1|Baseline|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
65868|NCT01976624|P1|Participant Flow|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
65869|NCT01976624|O1|Outcome|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
65870|NCT01976624|O1|Outcome|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
65871|NCT01976624|E1|Reported Event|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
65872|NCT01976572|B1|Baseline|All Subjects|
65873|NCT01976572|P3|Participant Flow|Treatment C|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan. On Day 13, the first daily dose of colestilan and candesartan was administered together (T0), and on Day 19 candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan.
65874|NCT01976572|P2|Participant Flow|Treatment B|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan. On Day 13, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan, and on Day 19, the first daily dose of colestilan and candesartan were administered together (T0).
65875|NCT01976572|P1|Participant Flow|Treatment A|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, the first daily dose of colestilan (5 g) and candesartan were administered together (T0). On Day 13, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan, and on Day 19 at 3 hours after (T+3) the first daily dose of colestilan.
65876|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
65877|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
65878|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
65879|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
65880|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
65882|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
65883|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
65884|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
65885|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
65886|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
65887|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
65888|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
65889|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
65890|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
65891|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
65892|NCT01976572|E3|Reported Event|Candesartan Plus Colestilan (Day 7 to 24)|
65893|NCT01976572|E2|Reported Event|Colestilan Alone (Day 3 to 6)|
65894|NCT01976572|E1|Reported Event|Candesartan Alone (Day 1 to 2)|
65895|NCT01976442|B3|Baseline|Total|Total of all reporting groups
65896|NCT01976442|B2|Baseline|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
65898|NCT01976442|P2|Participant Flow|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
65899|NCT01976442|P1|Participant Flow|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
65900|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
65901|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
65902|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
65903|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
65904|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
65905|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
65906|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
65907|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
65908|NCT01976442|E2|Reported Event|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
65909|NCT01976442|E1|Reported Event|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
65910|NCT01976338|B3|Baseline|Total|Total of all reporting groups
65911|NCT01976338|B2|Baseline|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65912|NCT01976338|B1|Baseline|Ranibizumab 0.5 mg|PRN Intravitreal injection
65913|NCT01976338|P2|Participant Flow|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65914|NCT01976338|P1|Participant Flow|Ranibizumab 0.5 mg|PRN Intravitreal injection
65915|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65916|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
65917|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65918|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
65919|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65920|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
65921|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65922|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
65923|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65924|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
65925|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65926|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
65927|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65928|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
65929|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65930|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
65931|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65932|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
65933|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65934|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
65935|NCT01976338|E3|Reported Event|Sham Without Ranibizumab 0.5 mg|sham + ranibizumab 0.5 mg PRN as of Month 6 (hereafter referred to as sham group up to Month 6 and sham with ranibizumab or sham without ranibizumab after Month 6)
65936|NCT01976338|E2|Reported Event|Sham With Ranibizumab 0.5 mg|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
65937|NCT01976338|E1|Reported Event|Ranibizumab 0.5 mg|PRN Intravitreal injection
65938|NCT01976312|B3|Baseline|Total|Total of all reporting groups
65939|NCT01976312|B2|Baseline|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
65940|NCT01976312|B1|Baseline|Ranibizumab 0.5 mg|PRN intravitreal injection
65945|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
65946|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
65947|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
65948|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
65949|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
65950|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
65951|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
65952|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
65953|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
65954|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
65955|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
65956|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
65957|NCT01976312|E3|Reported Event|Sham Without Ranibizumab 0.5 mg|Sham without Ranibizumab 0.5mg(hereafter referred to as sham group up to Month 3 and sham without ranibizumab after Month 3
65958|NCT01976312|E2|Reported Event|Sham With Ranibizumab 0.5 mg|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
65959|NCT01976312|E1|Reported Event|Ranibizumab 0.5 mg|PRN intravitreal injection
65960|NCT01976299|B3|Baseline|Total|Total of all reporting groups
65961|NCT01976299|B2|Baseline|Standard of Care|
65962|NCT01976299|B1|Baseline|Active Treatment|"Standard of Care with the AVERT system
AVERT"
65963|NCT01976299|P2|Participant Flow|Standard of Care|
65974|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system
AVERT"
65975|NCT01976299|E2|Reported Event|Standard of Care|
65976|NCT01976299|E1|Reported Event|Active Treatment|"Standard of Care with the AVERT system
AVERT"
65977|NCT01976273|B3|Baseline|Total|Total of all reporting groups
65978|NCT01976273|B2|Baseline|Glycolic Acid Peels Comparator Left, Q-Switch Laser Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.
Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the right side of their face, and the glycolic acids peels on the left side of their face."
65979|NCT01976273|B1|Baseline|Q-switch Laser Left, Glycolic Acid Peels Comparator Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.
Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the left side of their face, and the glycolic acids peels on the right side of their face."
65980|NCT01976273|P2|Participant Flow|Glycolic Acid Peels Comparator Left, Q-Switch Laser Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.
Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the right side of their face, and the glycolic acids peels on the left side of their face."
65981|NCT01976273|P1|Participant Flow|Q-switch Laser Left, Glycolic Acid Peels Comparator Right|"The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.
Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the left side of their face, and the glycolic acids peels on the right side of their face."
65982|NCT01976273|O2|Outcome|Glycolic Acid Peels|"A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin’s outermost layer.
Glycolic Acid Peels"
65983|NCT01976273|O1|Outcome|1064nm Q-switch Laser|"The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.
1064nm Q-switch Laser"
65984|NCT01976273|E2|Reported Event|Glycolic Acid Peels|"A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin’s outermost layer.
Glycolic Acid Peels"
65985|NCT01976273|E1|Reported Event|1064nm Q-switch Laser|"The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.
1064nm Q-switch Laser"
65986|NCT01975974|B1|Baseline|Ultrasound|"Ultrasound guided peripheral vascular access
Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
65987|NCT01975974|P1|Participant Flow|Ultrasound|"Ultrasound guided peripheral vascular access
Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
65988|NCT01975974|O1|Outcome|Ultrasound|"Ultrasound guided peripheral vascular access
Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
65989|NCT01975974|E1|Reported Event|Ultrasound|"Ultrasound guided peripheral vascular access
Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
65990|NCT01975948|B5|Baseline|Total|Total of all reporting groups
66054|NCT01975675|B4|Baseline|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66055|NCT01975675|B3|Baseline|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
65991|NCT01975948|B4|Baseline|Treatment as Usual: Patient Sample|"Patients of physician who were randomized in the control group (TAU).
Inclusion criteria included >18 years of age, with a diagnosis of depression, PHQ-9 score of > 10, able to read and speak in English at grade 6 level, and intact cognitive functioning (physician judgment). Exclusion criteria included active treatment with antidepressants within 5 weeks and psychotherapy within 3 months of enrollment, and clinically judged urgent or emergent medical/psychiatric condition by their physician."
65992|NCT01975948|B3|Baseline|Practice Support Program: Patient Sample|"Patients of physicians trained in the Adult Mental Health Practice Support Program.
Inclusion criteria included >18 years of age, with a diagnosis of depression, PHQ-9 score of > 10, able to read and speak in English at grade 6 level, and intact cognitive functioning (physician judgment). Exclusion criteria included active treatment with antidepressants within 5 weeks and psychotherapy within 3 months of enrollment, and clinically judged urgent or emergent medical/psychiatric condition by their physician."
65993|NCT01975948|B2|Baseline|Treatment as Usual: Physician Sample|"Treatment as Usual for Depression
Depression Treatment as Usual: Physicians manage patients with depression as usual"
65994|NCT01975948|B1|Baseline|Practice Support Program: Physician Sample|"Physician training in Adult Mental Health Practice Support Program
Mental Health Practice Support Program: (1) training and (2) practice support.
•Three half day workshop sessions over a 24 week period.
•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
65995|NCT01975948|P4|Participant Flow|Treatment as Usual: Patient Sample|Patients were assigned to the same arm as their physician, who were randomized to treating their patients as usual. Patients were enrolled between June 2014-May 2015 with the last follow-up visit in November 2015
65996|NCT01975948|P3|Participant Flow|Mental Health Practice Support Program;Patient Sample|Patients were assigned to the same arm as their physician who were randomized to the Practice Support Program training. Patients were enrolled between June 2014-May 2015 with the last follow-up visit in November 2015
65997|NCT01975948|P2|Participant Flow|Depression Treatment as Usual;Physician Sample|"Treatment as Usual for Depression
Depression Treatment as Usual: Physicians manage patients with depression as usual"
66031|NCT01975935|O1|Outcome|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo"
66032|NCT01975935|E2|Reported Event|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox"
65998|NCT01975948|P1|Participant Flow|Mental Health Practice Support Program;Physician Sample|"Physician training in Adult Mental Health Practice Support Program
Mental Health Practice Support Program: (1) training and (2) practice support.
•Three half day workshop sessions over a 24 week period.
•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
65999|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
66000|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
66001|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
66002|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
66003|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
66004|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
66005|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
66006|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
66007|NCT01975948|O2|Outcome|Treatment as Usual: Physicians|Depression Treatment as Usual: Physicians manage patients with depression as usual
66008|NCT01975948|O1|Outcome|Mental Health PSP: Physicians|"Physician training in Adult Mental Health Practice Support Program
Mental Health Practice Support Program: (1) training and (2) practice support.
•Three half day workshop sessions over a 24 week period.
•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
66009|NCT01975948|O2|Outcome|Treatment as Usual: Physicians|Depression Treatment as Usual: Physicians manage patients with depression as usual
66010|NCT01975948|O1|Outcome|Mental Health PSP: Physicians|"Physician training in Adult Mental Health Practice Support Program
Mental Health Practice Support Program: (1) training and (2) practice support.
•Three half day workshop sessions over a 24 week period.
•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
66011|NCT01975948|O2|Outcome|Treatment as Usual: Physician Sample|"Treatment as Usual for Depression
Depression Treatment as Usual: Physicians manage patients with depression as usual"
66012|NCT01975948|O1|Outcome|Practice Support Program: Physician Sample|"Physician training in Adult Mental Health Practice Support Program
Mental Health Practice Support Program: (1) training and (2) practice support.
•Three half day workshop sessions over a 24 week period.
•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
66013|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
66014|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
66015|NCT01975948|O2|Outcome|Treatment as Usual: Physicians|Depression Treatment as Usual: Physicians manage patients with depression as usual
66056|NCT01975675|B2|Baseline|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66057|NCT01975675|B1|Baseline|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
66016|NCT01975948|O1|Outcome|Mental Health PSP: Physicians|"Physician training in Adult Mental Health Practice Support Program
Mental Health Practice Support Program: (1) training and (2) practice support.
•Three half day workshop sessions over a 24 week period.
•Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
66017|NCT01975948|O2|Outcome|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
66018|NCT01975948|O1|Outcome|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
66019|NCT01975948|E2|Reported Event|Treatment as Usual: Patients|Those receiving treatment as usual for depression.
66020|NCT01975948|E1|Reported Event|Mental Health PSP: Patients|Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
66021|NCT01975935|B3|Baseline|Total|Total of all reporting groups
66022|NCT01975935|B2|Baseline|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox"
66023|NCT01975935|B1|Baseline|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo"
66024|NCT01975935|P2|Participant Flow|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox"
66025|NCT01975935|P1|Participant Flow|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo"
66026|NCT01975935|O2|Outcome|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox"
66027|NCT01975935|O1|Outcome|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo"
66028|NCT01975935|O2|Outcome|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox"
66029|NCT01975935|O1|Outcome|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo"
66030|NCT01975935|O2|Outcome|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Amlexanox"
93618|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
66033|NCT01975935|E1|Reported Event|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Placebo"
66034|NCT01975909|B3|Baseline|Total|Total of all reporting groups
66035|NCT01975909|B2|Baseline|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66036|NCT01975909|B1|Baseline|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66037|NCT01975909|P2|Participant Flow|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66038|NCT01975909|P1|Participant Flow|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66039|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66040|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66041|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66042|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66043|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66044|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66045|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66069|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
66211|NCT01974752|B2|Baseline|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
66046|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66047|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66048|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66049|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66050|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66051|NCT01975909|E2|Reported Event|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66052|NCT01975909|E1|Reported Event|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.
Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
66053|NCT01975675|B5|Baseline|Total|Total of all reporting groups
66523|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66058|NCT01975675|P4|Participant Flow|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66059|NCT01975675|P3|Participant Flow|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
66060|NCT01975675|P2|Participant Flow|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus ribavirin (RBV) tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66061|NCT01975675|P1|Participant Flow|LDV/SOF (Treatment Naive)|Treatment-naive participants received ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
66062|NCT01975675|O2|Outcome|LDV/SOF+RBV|Participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66063|NCT01975675|O1|Outcome|LDV/SOF|Participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
66064|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66065|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
66066|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66067|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
66068|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66212|NCT01974752|B1|Baseline|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
66070|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66071|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
66072|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66073|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
66074|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66075|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
66076|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66077|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
66078|NCT01975675|E2|Reported Event|LDV/SOF+RBV|Participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
66079|NCT01975675|E1|Reported Event|LDV/SOF|Participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
66080|NCT01975467|B3|Baseline|Total|Total of all reporting groups
66081|NCT01975467|B2|Baseline|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.
CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
66082|NCT01975467|B1|Baseline|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
66083|NCT01975467|P2|Participant Flow|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.
CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
66084|NCT01975467|P1|Participant Flow|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
66085|NCT01975467|O2|Outcome|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.
CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
66086|NCT01975467|O1|Outcome|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
66087|NCT01975467|O2|Outcome|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.
CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
66088|NCT01975467|O1|Outcome|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
66089|NCT01975467|E2|Reported Event|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.
CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
66090|NCT01975467|E1|Reported Event|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
66091|NCT01975285|B3|Baseline|Total|Total of all reporting groups
66092|NCT01975285|B2|Baseline|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
66093|NCT01975285|B1|Baseline|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc
Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
66094|NCT01975285|P2|Participant Flow|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
66095|NCT01975285|P1|Participant Flow|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc
Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
66096|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
66097|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc
Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
66098|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
66099|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc
Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
66100|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
66101|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc
Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
66102|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
66103|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc
Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
66104|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
66105|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc
Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
93621|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
66106|NCT01975285|E2|Reported Event|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
66107|NCT01975285|E1|Reported Event|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc
Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
66108|NCT01975246|B3|Baseline|Total|Total of all reporting groups
66109|NCT01975246|B2|Baseline|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
66110|NCT01975246|B1|Baseline|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
66111|NCT01975246|P2|Participant Flow|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
66112|NCT01975246|P1|Participant Flow|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
66113|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
66114|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
66115|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
66116|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
66117|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
66118|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
66119|NCT01975246|E2|Reported Event|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
66120|NCT01975246|E1|Reported Event|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
66121|NCT01975220|B4|Baseline|Total|Total of all reporting groups
66122|NCT01975220|B3|Baseline|Low Dose, Fasted|"2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fasted conditions:
12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;
1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
66123|NCT01975220|B2|Baseline|High Dose, Fed|"1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions:
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
66124|NCT01975220|B1|Baseline|High Dose, Fasted|"1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions:
25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
66297|NCT01973777|B1|Baseline|IUB Inserted|"There is one arm of women who will have IUBs inserted
IUB: intrauterine contraceptive device"
66125|NCT01975220|P6|Participant Flow|Low Dose, Fasted: 4 Single Tablets First, Then 2 FDC Tablets|"4 single tablets first, then 2 fixed low dose combination (FDC) tablets under fasted conditions:
1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets;
12.5 mg Empagliflozin/750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets"
66126|NCT01975220|P5|Participant Flow|Low Dose, Fasted: 2 FDC Tablets First, Then 4 Single Tablets|"2 fixed low dose combination (FDC) tablets first, then 4 single tablets under fasted conditions:
12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;
1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
66127|NCT01975220|P4|Participant Flow|High Dose, Fed: 3 Single Tablets First, Then 1 FDC Tablet|"3 single tablets first, then 1 fixed dose combination (FDC) tablet under fed conditions:
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
66128|NCT01975220|P3|Participant Flow|High Dose, Fed: 1 FDC Tablet First, Then 3 Single Tablets|"1 fixed dose combination (FDC) tablet first, then 3 single tablets under fed conditions:
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
66129|NCT01975220|P2|Participant Flow|High Dose, Fasted: 3 Single Tablets First, Then 1 FDC Tablet|"3 single tablets first, then 1 fixed dose combination (FDC) tablet under fasted conditions:
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
66171|NCT01975220|E2|Reported Event|High Dose, Fasted: 3 Single Tablets|"3 single tablets under fasted conditions:
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
66213|NCT01974752|P2|Participant Flow|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
66130|NCT01975220|P1|Participant Flow|High Dose, Fasted: 1 FDC Tablet First, Then 3 Single Tablets|"1 fixed dose combination (FDC) tablet first, then 3 single tablets under fasted conditions:
25 mg Empagliflozin/1000 mg Metformin extended release (XR), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
66131|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
66132|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
66133|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66134|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
66135|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66136|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
66137|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
66138|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
66139|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66140|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
66141|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66142|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
66143|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
66144|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
66145|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66146|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
66147|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66148|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
66149|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
66150|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
66151|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66152|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
66153|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66154|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
66155|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablets Empagliflozin / 3 x 500 mg tablets Metformin XR
66156|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
66157|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66158|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
66159|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66160|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
66161|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
66162|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
66163|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66164|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
66165|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
66166|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
66167|NCT01975220|E6|Reported Event|Low Dose, Fasted: 4 Single Tablets|"4 single tablets under fed conditions:
1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
66168|NCT01975220|E5|Reported Event|Low Dose, Fasted: 2 FDC Tablets|"2 fixed dose combination (FDC) tablets under fasted conditions:
12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets"
66169|NCT01975220|E4|Reported Event|High Dose, Fed: 3 Single Tablets|"3 single tablets under fed conditions:
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
66170|NCT01975220|E3|Reported Event|High Dose, Fed: 1 FDC Tablet|"1 fixed dose combination (FDC) tablet under fed conditions:
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
93719|NCT01820416|B4|Baseline|Total|Total of all reporting groups
66172|NCT01975220|E1|Reported Event|High Dose, Fasted: 1 FDC Tablet|"1 fixed dose combination (FDC) tablet under fasted conditions:
25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR, FDC tablet"
66173|NCT01974895|B3|Baseline|Total|Total of all reporting groups
66174|NCT01974895|B2|Baseline|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66175|NCT01974895|B1|Baseline|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66176|NCT01974895|P2|Participant Flow|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66177|NCT01974895|P1|Participant Flow|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66178|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66179|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66180|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66181|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66182|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66183|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66184|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66185|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66186|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66187|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66188|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66189|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66190|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66191|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66192|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66193|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66194|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66195|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66196|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66197|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66524|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66198|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66199|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66200|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66201|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66202|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66203|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66204|NCT01974895|E2|Reported Event|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
66205|NCT01974895|E1|Reported Event|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
66206|NCT01974817|B1|Baseline|Vaccine|"Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.
13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose"
66207|NCT01974817|P1|Participant Flow|Vaccine|"Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.
13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose"
66208|NCT01974817|O1|Outcome|Vaccine Arm|A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
66209|NCT01974817|E1|Reported Event|Vaccine Arm|A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
66210|NCT01974752|B3|Baseline|Total|Total of all reporting groups
66214|NCT01974752|P1|Participant Flow|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
66215|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
66216|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
66217|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
66218|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
66219|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
66220|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
66221|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
66222|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
66223|NCT01974752|E2|Reported Event|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
66224|NCT01974752|E1|Reported Event|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
66225|NCT01974700|B3|Baseline|Total|Total of all reporting groups
66226|NCT01974700|B2|Baseline|No Anti-epileptic Treatment|
66227|NCT01974700|B1|Baseline|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
66228|NCT01974700|P2|Participant Flow|No Anti-epileptic Treatment|
66229|NCT01974700|P1|Participant Flow|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
66230|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
66231|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
66232|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
66233|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
66234|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
66235|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
66236|NCT01974700|E2|Reported Event|No Anti-epileptic Treatment|
66237|NCT01974700|E1|Reported Event|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
66238|NCT01974323|B3|Baseline|Total|Total of all reporting groups
66239|NCT01974323|B2|Baseline|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66240|NCT01974323|B1|Baseline|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66241|NCT01974323|P2|Participant Flow|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66242|NCT01974323|P1|Participant Flow|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66243|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66244|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66245|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66246|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66247|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66248|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66249|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66250|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66251|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66252|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66253|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66254|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66255|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66256|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66257|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66258|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66259|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66260|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66261|NCT01974323|E2|Reported Event|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66262|NCT01974323|E1|Reported Event|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66263|NCT01974245|B3|Baseline|Total|Total of all reporting groups
66264|NCT01974245|B2|Baseline|Cholecalciferol|Cholecalciferol: 100,000 IU/week
66265|NCT01974245|B1|Baseline|Placebo|100 drops/week
66266|NCT01974245|P2|Participant Flow|Cholecalciferol|Cholecalciferol: 100,000 IU/week
66267|NCT01974245|P1|Participant Flow|Placebo|100 drops placebo solution/week
66268|NCT01974245|O2|Outcome|Cholecalciferol|Cholecalciferol: 100,000 IU/week for 12 weeks
66269|NCT01974245|O1|Outcome|Placebo|100 drops/week for 12 weeks
66270|NCT01974245|E2|Reported Event|Cholecalciferol|Cholecalciferol: 100,000 IU/week for 12 weeks
66271|NCT01974245|E1|Reported Event|Placebo|100 drops/week for 12 weeks
66272|NCT01974141|B3|Baseline|Total|Total of all reporting groups
66273|NCT01974141|B2|Baseline|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66274|NCT01974141|B1|Baseline|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66275|NCT01974141|P2|Participant Flow|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66276|NCT01974141|P1|Participant Flow|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66277|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66278|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66279|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66280|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66281|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66282|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66283|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66284|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66285|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66286|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66287|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66288|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66289|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66290|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66291|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66292|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66293|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66294|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66295|NCT01974141|E2|Reported Event|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66296|NCT01974141|E1|Reported Event|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
66298|NCT01973777|P1|Participant Flow|IUB Inserted|"There is one arm of women who will have IUBs inserted
IUB: intrauterine contraceptive device"
66299|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted
IUB: intrauterine contraceptive device"
66300|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted
IUB: intrauterine contraceptive device"
66301|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted
IUB: intrauterine contraceptive device"
66302|NCT01973777|E1|Reported Event|IUB Inserted|"There is one arm of women who will have IUBs inserted
IUB: intrauterine contraceptive device"
66303|NCT01973608|B5|Baseline|Total|Total of all reporting groups
66304|NCT01973608|B4|Baseline|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
66305|NCT01973608|B3|Baseline|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
66343|NCT01973595|O2|Outcome|No Almonds Consumption Control (Parents)|"Parents were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control."
66344|NCT01973595|O1|Outcome|Almonds Consumption (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
66306|NCT01973608|B2|Baseline|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
66307|NCT01973608|B1|Baseline|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
66308|NCT01973608|P4|Participant Flow|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66309|NCT01973608|P3|Participant Flow|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66310|NCT01973608|P2|Participant Flow|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66311|NCT01973608|P1|Participant Flow|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as intravenous (IV) infusion over approximately 1 hour every 3 weeks (q3w) for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of Stereotactic Body Radiation Therapy (SBRT) to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site was targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66335|NCT01973595|P2|Participant Flow|No Almonds, Then Almonds (Parents)|Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
66364|NCT01973491|E1|Reported Event|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66312|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
66313|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
66314|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
66547|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66315|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
66316|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66317|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66318|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66319|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66320|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66336|NCT01973595|P1|Participant Flow|Almonds, Then no Almonds (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.
Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
66337|NCT01973595|O4|Outcome|No Almonds Consumption Control (Children)|"Children were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control."
66525|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66321|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66322|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66345|NCT01973595|O2|Outcome|No Almonds Consumption Control|"Participants were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control."
66480|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
66323|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66324|NCT01973608|E4|Reported Event|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66325|NCT01973608|E3|Reported Event|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66326|NCT01973608|E2|Reported Event|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66327|NCT01973608|E1|Reported Event|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
66328|NCT01973595|B5|Baseline|Total|Total of all reporting groups
66329|NCT01973595|B4|Baseline|No Almonds, Then Almonds (Children)|Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
66330|NCT01973595|B3|Baseline|Almonds, Then no Almonds (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.
Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste"
66331|NCT01973595|B2|Baseline|No Almonds, Then Almonds (Parents)|Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
66332|NCT01973595|B1|Baseline|Almonds, Then no Almonds (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.
Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
66333|NCT01973595|P4|Participant Flow|No Almonds Then Almonds (Children)|Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
66334|NCT01973595|P3|Participant Flow|Almonds, Then no Almonds (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.
Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
66338|NCT01973595|O3|Outcome|Almonds Consumption (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
66339|NCT01973595|O2|Outcome|No Almonds Consumption Control (Parents)|"Parents were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control."
66340|NCT01973595|O1|Outcome|Almonds Consumption (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
66341|NCT01973595|O2|Outcome|No Almond Consumption Control|"Participants were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
Each group received the almond intervention and the no almond consumption control."
66342|NCT01973595|O1|Outcome|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
94700|NCT01813721|O2|Outcome|Non-small Cell Lung Cancer|
66346|NCT01973595|O1|Outcome|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
66347|NCT01973595|E2|Reported Event|No Almonds Consumption Control|"Participants were asked not to consume almonds for 3 weeks.
Each group received the almond intervention and the no almond consumption control."
66348|NCT01973595|E1|Reported Event|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.
Each group received the almond intervention and the no almond consumption control.
Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
66349|NCT01973491|B1|Baseline|ATX-MS-1467|Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66350|NCT01973491|P1|Participant Flow|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66351|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66352|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66353|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66354|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66355|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66356|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66357|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66358|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66359|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66360|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66361|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66362|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66363|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
66365|NCT01973439|B1|Baseline|Single Arm|This is a single arm crossover study First intervention: PK assessment while on Twice Daily Abacavir Second intervention: PK assessment while on Once Daily Abacavir
66366|NCT01973439|P1|Participant Flow|Single Arm|"This is a single arm crossover study
st intervention: PK assessment while on Twice Daily Abacavir
nd intervention: PK assessment while on Once Daily Abacavir"
66367|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
66368|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
66369|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
66370|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
66371|NCT01973439|E1|Reported Event|Abacavir Once Versus Twice Daily|This is a single arm study. Intervention 1: PK assessment while on Twice Daily Abacavir (Week 0) Intervention 2: PK assessment while on Once Daily Abacavir (Week 4)
66372|NCT01973413|B3|Baseline|Total|Total of all reporting groups
66386|NCT01973387|B2|Baseline|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
66387|NCT01973387|B1|Baseline|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
66543|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66373|NCT01973413|B2|Baseline|Camp Study|"The second phase of this proposal was the in-camp studies. The same health care providers that conducted the inpatient studies conducted the camp studies. They monitored all campers on closed-loop control in real-time. Participants were randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Since participants were not always successfully completing a closed-loop control night, the pattern could not hold throughout the entire trial. Thus, there are numerous intervention sequences.
Those assigned to DiAs closed-loop control were remotely monitored throughout the night. Those assigned to the control group were not monitored remotely overnight, but they were wearing Dexcom G4 Platinum sensors with active low and high sensor glucose alarms."
66374|NCT01973413|B1|Baseline|Inpatient Study|The first phase of this study tested the feasibility of initializing the DiAs CTR system in a clinical research center. We tested the procedures that would occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We also tested how the system would perform using the same calibration and blood glucose monitoring that would be done at camp. In the inpatient study mimicked some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies was reviewed by the Data Safety Monitoring Board (DSMB) before we proceeded with the Phase 2 summer camp studies.
66375|NCT01973413|P2|Participant Flow|Camp Study|"The second phase of this proposal was the in-camp studies. The same health care providers that conducted the inpatient studies conducted the camp studies. They monitored all campers on closed-loop control in real-time. Participants were randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Since participants were not always successfully completing a closed-loop control night, the pattern could not hold throughout the entire trial. Thus, there are numerous intervention sequences.
Those assigned to DiAs closed-loop control were remotely monitored throughout the night. Those assigned to the control group were not monitored remotely overnight, but they were wearing Dexcom G4 Platinum sensors with active low and high sensor glucose alarms."
66376|NCT01973413|P1|Participant Flow|Inpatient Study|The first phase of this study tested the feasibility of initializing the DiAs CTR system in a clinical research center. We tested the procedures that would occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We also tested how the system would perform using the same calibration and blood glucose monitoring that would be done at camp. In the inpatient study mimicked some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies was reviewed by the Data Safety Monitoring Board (DSMB) before we proceeded with the Phase 2 summer camp studies.
66377|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
66378|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.
Diabetes Assistant (DiAs): The Control-to-Range (CTR)algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
66379|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
66380|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.
Diabetes Assistant (DiAs): The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
66381|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
66412|NCT01973348|O3|Outcome|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia
12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
66382|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.
Diabetes Assistant (DiAs): The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
66383|NCT01973413|E2|Reported Event|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
66384|NCT01973413|E1|Reported Event|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.
Diabetes Assistant (DiAs): The Control-to-Range (CTR)algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
66385|NCT01973387|B3|Baseline|Total|Total of all reporting groups
66544|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66545|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66388|NCT01973387|P2|Participant Flow|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
66389|NCT01973387|P1|Participant Flow|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
66390|NCT01973387|O2|Outcome|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
66391|NCT01973387|O1|Outcome|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
66392|NCT01973387|O2|Outcome|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
66393|NCT01973387|O1|Outcome|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
66394|NCT01973387|O2|Outcome|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
66395|NCT01973387|O1|Outcome|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
66396|NCT01973387|E2|Reported Event|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
66397|NCT01973387|E1|Reported Event|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
66398|NCT01973348|B5|Baseline|Total|Total of all reporting groups
66399|NCT01973348|B4|Baseline|6-hour Eye Patching|"6-hour eye patching for severe amblyopia
6-hour patching: 6-hour patching for severe amblyopia"
66400|NCT01973348|B3|Baseline|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia
12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
66401|NCT01973348|B2|Baseline|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia
2-hour patching: 2-hour patching for moderate amblyopia"
66402|NCT01973348|B1|Baseline|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia
4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
66403|NCT01973348|P4|Participant Flow|6-hour Eye Patching|"6-hour eye patching for severe amblyopia
6-hour patching: 6-hour patching for severe amblyopia"
66404|NCT01973348|P3|Participant Flow|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia
12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
66405|NCT01973348|P2|Participant Flow|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia
2-hour patching: 2-hour patching for moderate amblyopia"
66406|NCT01973348|P1|Participant Flow|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia
4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
66407|NCT01973348|O4|Outcome|6-hour Eye Patching|"6-hour eye patching for severe amblyopia
6-hour patching: 6-hour patching for severe amblyopia"
66408|NCT01973348|O3|Outcome|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia
12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
66409|NCT01973348|O2|Outcome|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia
2-hour patching: 2-hour patching for moderate amblyopia"
66410|NCT01973348|O1|Outcome|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia
4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
66411|NCT01973348|O4|Outcome|6-hour Eye Patching|"6-hour eye patching for severe amblyopia
6-hour patching: 6-hour patching for severe amblyopia"
66413|NCT01973348|O2|Outcome|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia
2-hour patching: 2-hour patching for moderate amblyopia"
66414|NCT01973348|O1|Outcome|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia
4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
66415|NCT01973348|O4|Outcome|6-hour Eye Patching|"6-hour eye patching for severe amblyopia
6-hour patching: 6-hour patching for severe amblyopia"
66416|NCT01973348|O3|Outcome|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia
12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
66417|NCT01973348|O2|Outcome|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia
2-hour patching: 2-hour patching for moderate amblyopia"
66418|NCT01973348|O1|Outcome|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia
4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
66419|NCT01973348|E4|Reported Event|6-hour Eye Patching|"6-hour eye patching for severe amblyopia
6-hour patching: 6-hour patching for severe amblyopia"
66420|NCT01973348|E3|Reported Event|12-hour AmblyZ Glasses|"12-hour AmblyZ glasses for severe amblyopia
12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia"
66421|NCT01973348|E2|Reported Event|2-hour Eye Patching|"2-hour eye patching for moderate amblyopia
2-hour patching: 2-hour patching for moderate amblyopia"
66422|NCT01973348|E1|Reported Event|4-hour AmblyZ Glasses|"4-hour AmblyZ glasses for moderate amblyopia
4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia"
66423|NCT01973231|B3|Baseline|Total|Total of all reporting groups
66479|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
66424|NCT01973231|B2|Baseline|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
66425|NCT01973231|B1|Baseline|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
66426|NCT01973231|P2|Participant Flow|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
66427|NCT01973231|P1|Participant Flow|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
66428|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
66429|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
66430|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
66431|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
66432|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
66433|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
66434|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
66435|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
66436|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
66437|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
66438|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
66439|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
66440|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
94701|NCT01813721|O1|Outcome|Breast Cancer|
66441|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
66442|NCT01973231|E2|Reported Event|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
66443|NCT01973231|E1|Reported Event|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
66444|NCT01973218|B3|Baseline|Total|Total of all reporting groups
66445|NCT01973218|B2|Baseline|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
66446|NCT01973218|B1|Baseline|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
66447|NCT01973218|P2|Participant Flow|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
66448|NCT01973218|P1|Participant Flow|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
66449|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
66450|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
66451|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
66452|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
66453|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
66454|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
66455|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
66456|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
66457|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
66458|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
66459|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
66460|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
66461|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
66462|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
66463|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
66464|NCT01973218|O1|Outcome|rMenb|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
66465|NCT01973218|E3|Reported Event|Total|Total of subjects
66466|NCT01973218|E2|Reported Event|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
66467|NCT01973218|E1|Reported Event|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
66468|NCT01973205|B3|Baseline|Total|Total of all reporting groups
66469|NCT01973205|B2|Baseline|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
66470|NCT01973205|B1|Baseline|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
66471|NCT01973205|P2|Participant Flow|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
66472|NCT01973205|P1|Participant Flow|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
66473|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
66474|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
66475|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
66476|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
66477|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
66478|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
66546|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66481|NCT01973205|E2|Reported Event|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
66482|NCT01973205|E1|Reported Event|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
66483|NCT01972776|B7|Baseline|Total|Total of all reporting groups
66484|NCT01972776|B6|Baseline|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66485|NCT01972776|B5|Baseline|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66486|NCT01972776|B4|Baseline|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
66487|NCT01972776|B3|Baseline|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66488|NCT01972776|B2|Baseline|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66489|NCT01972776|B1|Baseline|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66490|NCT01972776|P6|Participant Flow|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66491|NCT01972776|P5|Participant Flow|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66492|NCT01972776|P4|Participant Flow|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
66493|NCT01972776|P3|Participant Flow|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66494|NCT01972776|P2|Participant Flow|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66495|NCT01972776|P1|Participant Flow|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66496|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66497|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66498|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66499|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66500|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66501|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66502|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66503|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66504|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66505|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66506|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66507|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66508|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66509|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66510|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
66511|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66512|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66513|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66514|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
66515|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66516|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66517|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66518|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
66519|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66520|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66521|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66522|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
66526|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66527|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66528|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66529|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66530|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66531|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66532|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66533|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66534|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66535|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66536|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66537|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66538|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66539|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66540|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66541|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66542|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66548|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66549|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66550|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
66551|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
66552|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
66553|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
66554|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
66555|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
66556|NCT01972776|E6|Reported Event|Part 2:QBM076 B.I.D Placebo|Part 2:QBM076 B.I.D Placebo
66557|NCT01972776|E5|Reported Event|Part 2: QBM076 B.I.D 150 mg|Part 2: QBM076 B.I.D 150 mg
66558|NCT01972776|E4|Reported Event|Part 1: Placebo|Part 1: Placebo
66559|NCT01972776|E3|Reported Event|Part 1: QBM076 B.I.D 150 mg|Part 1: QBM076 B.I.D 150 mg
66560|NCT01972776|E2|Reported Event|Part 1: QBM076 B.I.D 75 mg|Part 1: QBM076 B.I.D 75 mg
66561|NCT01972776|E1|Reported Event|Part 1: QBM076 B.I.D 25 mg|Part 1: QBM076 B.I.D 25 mg
66562|NCT01972659|B3|Baseline|Total|Total of all reporting groups
66563|NCT01972659|B2|Baseline|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery
Magnesium Sulphate: Experimental :
50 mg/kg bolus plus 15 mg/kg continuous infusion
sugammadex: 4 mg/kg iv bolus at the end of the surgery"
66564|NCT01972659|B1|Baseline|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery
placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
sugammadex: 4 mg/kg iv bolus at the end of the surgery"
66565|NCT01972659|P2|Participant Flow|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery
Magnesium Sulphate: Experimental :
50 mg/kg bolus plus 15 mg/kg continuous infusion
sugammadex: 4 mg/kg iv bolus at the end of the surgery"
66566|NCT01972659|P1|Participant Flow|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery
placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
sugammadex: 4 mg/kg iv bolus at the end of the surgery"
66567|NCT01972659|O2|Outcome|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery
Magnesium Sulphate: Experimental :
50 mg/kg bolus plus 15 mg/kg continuous infusion
sugammadex: 4 mg/kg iv bolus at the end of the surgery"
66568|NCT01972659|O1|Outcome|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery
placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
sugammadex: 4 mg/kg iv bolus at the end of the surgery"
66569|NCT01972659|E2|Reported Event|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery
Magnesium Sulphate: Experimental :
50 mg/kg bolus plus 15 mg/kg continuous infusion
sugammadex: 4 mg/kg iv bolus at the end of the surgery"
66570|NCT01972659|E1|Reported Event|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery
placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
sugammadex: 4 mg/kg iv bolus at the end of the surgery"
66571|NCT01972516|B3|Baseline|Total|Total of all reporting groups
66572|NCT01972516|B2|Baseline|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
66573|NCT01972516|B1|Baseline|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
66574|NCT01972516|P2|Participant Flow|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
66575|NCT01972516|P1|Participant Flow|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
66576|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
66577|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
66578|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
66603|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66579|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
66580|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
66581|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
66582|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
66583|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
66584|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
66585|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
66586|NCT01972516|E2|Reported Event|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
66587|NCT01972516|E1|Reported Event|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
66588|NCT01972438|B3|Baseline|Total|Total of all reporting groups
66589|NCT01972438|B2|Baseline|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66590|NCT01972438|B1|Baseline|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66591|NCT01972438|P2|Participant Flow|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66592|NCT01972438|P1|Participant Flow|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66593|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66594|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66595|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66596|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66597|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66598|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66599|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66600|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66601|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66602|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66716|NCT01971554|B5|Baseline|Total|Total of all reporting groups
66604|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66605|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66606|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66607|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66608|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66609|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66610|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66611|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66612|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66613|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66614|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66615|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66616|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66617|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66618|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66619|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66857|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
66620|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66621|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66622|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66623|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66624|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66625|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66626|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66627|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66628|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66629|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66630|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66631|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66632|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66633|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66634|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66635|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66636|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66637|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention"
66638|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention"
66639|NCT01972438|E4|Reported Event|No Intervention|Adverse event occurred prior to participants receiving either intervention. Neither ASEDs nor normal saline eye drops were being taken when the event occurred.
66640|NCT01972438|E3|Reported Event|ASEDs or Saline|Adverse event occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops daily if desired.
66641|NCT01972438|E2|Reported Event|Saline|Adverse event occurred when participants were receiving control (normal saline) eye drops daily during the crossover period (first six months) of the study.
66642|NCT01972438|E1|Reported Event|ASEDs|Adverse event occurred when participants were receiving autologous serum eye drops (ASEDs) daily during the crossover period (first six months) of the study.
66643|NCT01972152|B1|Baseline|Total Study Group|Includes all 30 randomized subjects
66644|NCT01972152|P6|Participant Flow|Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 3.
66645|NCT01972152|P5|Participant Flow|Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
66646|NCT01972152|P4|Participant Flow|G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection of at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 3.
66647|NCT01972152|P3|Participant Flow|G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg|G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 3.
66648|NCT01972152|P2|Participant Flow|G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 2, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
66649|NCT01972152|P1|Participant Flow|G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg|G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 3.
66650|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
66651|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
66652|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
66653|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
66654|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
66655|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
66717|NCT01971554|B4|Baseline|Placebo|Placebo once daily for 14 consecutive days
66656|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
66657|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
66658|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
66659|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
66660|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
66661|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
66662|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
66663|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
66664|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
66665|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
66666|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
66667|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
66668|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
66669|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
66670|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
66671|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
66672|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
66673|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
66674|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
66675|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
66676|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
66677|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|"Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg"
66678|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|"G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg"
66679|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|"G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg"
66680|NCT01972152|E3|Reported Event|Lilly Glucagon(TM) 1 mg|"Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg"
66681|NCT01972152|E2|Reported Event|G-Pen(TM) 0.5 mg|"G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg"
66682|NCT01972152|E1|Reported Event|G-Pen(TM) 1 mg|"G-Pen(TM) (glucagon injection), single 1 mg SC injection
G-Pen(TM) 1 mg
Lilly Glucagon(TM) 1 mg
G-Pen(TM) 0.5 mg"
66683|NCT01971723|B3|Baseline|Total|Total of all reporting groups
66684|NCT01971723|B2|Baseline|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66698|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66685|NCT01971723|B1|Baseline|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66686|NCT01971723|P2|Participant Flow|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66687|NCT01971723|P1|Participant Flow|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66688|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66718|NCT01971554|B3|Baseline|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
66719|NCT01971554|B2|Baseline|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
66720|NCT01971554|B1|Baseline|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
66689|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66690|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66691|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66692|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66693|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66694|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66695|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66696|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66697|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66761|NCT01971255|P1|Participant Flow|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of =1:40 were assigned to this group.
66699|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66700|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66701|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66702|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
94702|NCT01813721|O4|Outcome|Comprehensive Cancer Center|
66703|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66704|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66705|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66706|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66707|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66708|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66709|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66710|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66711|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66762|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
66858|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
66712|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66713|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66714|NCT01971723|E2|Reported Event|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.
Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
66715|NCT01971723|E1|Reported Event|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.
T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
66721|NCT01971554|P4|Participant Flow|Placebo|Placebo once daily for 14 consecutive days
66722|NCT01971554|P3|Participant Flow|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
66723|NCT01971554|P2|Participant Flow|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
66724|NCT01971554|P1|Participant Flow|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
66725|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
66726|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
66727|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
66728|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
66729|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
66730|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
66731|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
66732|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
66733|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
66734|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
66735|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
66736|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
66737|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
66738|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
66739|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
66740|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
66741|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
66742|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
66743|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
66744|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
66745|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
66746|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
66747|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
66748|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
66749|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
66750|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
66751|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
66752|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
66753|NCT01971554|E4|Reported Event|Placebo|Placebo once daily for 14 consecutive days
66754|NCT01971554|E3|Reported Event|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
66755|NCT01971554|E2|Reported Event|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
66756|NCT01971554|E1|Reported Event|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
66757|NCT01971255|B3|Baseline|Total|Total of all reporting groups
66758|NCT01971255|B2|Baseline|Low Titer (HAI < 1:40)|Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 at the time of planned inoculation and were placed in this group.
66759|NCT01971255|B1|Baseline|High Titer (HAI > 1:40)|Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 at the time of planned inoculation were placed in this group.
66760|NCT01971255|P2|Participant Flow|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of <1:40 were assigned to this group.
66763|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
66764|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
66765|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
66766|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
66767|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
66768|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
66769|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
66770|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
66771|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
66772|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
66773|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
66774|NCT01971255|E2|Reported Event|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
66775|NCT01971255|E1|Reported Event|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
66776|NCT01971086|B1|Baseline|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66777|NCT01971086|P1|Participant Flow|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66778|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66779|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66780|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66781|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66782|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66783|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66784|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66785|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66786|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66787|NCT01971086|E1|Reported Event|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
66788|NCT01970995|B4|Baseline|Total|Total of all reporting groups
66789|NCT01970995|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
66790|NCT01970995|B2|Baseline|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
66791|NCT01970995|B1|Baseline|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
66792|NCT01970995|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
66793|NCT01970995|P2|Participant Flow|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
66794|NCT01970995|P1|Participant Flow|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
66795|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
66796|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
66797|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
66798|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
66799|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
66800|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
66801|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
66802|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
66803|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
66804|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
66805|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
66806|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
66807|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
66808|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
66809|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
66810|NCT01970995|E3|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
66811|NCT01970995|E2|Reported Event|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
66812|NCT01970995|E1|Reported Event|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
66813|NCT01970982|B4|Baseline|Total|Total of all reporting groups
66814|NCT01970982|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
66815|NCT01970982|B2|Baseline|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
66816|NCT01970982|B1|Baseline|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
66817|NCT01970982|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
66818|NCT01970982|P2|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
66819|NCT01970982|P1|Participant Flow|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
66820|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
66821|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
66822|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
66823|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
66824|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
66825|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
66826|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
66827|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
66828|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
66829|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
66830|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
66831|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
66832|NCT01970982|E4|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects
66833|NCT01970982|E3|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
66834|NCT01970982|E2|Reported Event|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
66835|NCT01970982|E1|Reported Event|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
66836|NCT01970878|B5|Baseline|Total|Total of all reporting groups
66837|NCT01970878|B4|Baseline|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
66838|NCT01970878|B3|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg
66839|NCT01970878|B2|Baseline|GP MDI (PT001)|GP MDI 14.4 mcg
66840|NCT01970878|B1|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
66841|NCT01970878|P4|Participant Flow|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
66842|NCT01970878|P3|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg
66843|NCT01970878|P2|Participant Flow|GP MDI (PT001)|GP MDI 14.4 mcg
66844|NCT01970878|P1|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
66845|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
66846|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
66847|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
66848|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
66849|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
66850|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
66851|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
66852|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
66853|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
66854|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
66855|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
66856|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
66861|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
66862|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
66863|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
66864|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
66865|NCT01970878|E4|Reported Event|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
66866|NCT01970878|E3|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg
66867|NCT01970878|E2|Reported Event|GP MDI (PT001)|GP MDI 14.4 mcg
66868|NCT01970878|E1|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
66869|NCT01970787|B1|Baseline|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions
Radiofrequency Ablation (RFA) using the HALO Ablation System"
66870|NCT01970787|P1|Participant Flow|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions
Radiofrequency Ablation (RFA) using the HALO Ablation System"
66871|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions
Radiofrequency Ablation (RFA) using the HALO Ablation System"
66872|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions
Radiofrequency Ablation (RFA) using the HALO Ablation System"
66873|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions
Radiofrequency Ablation (RFA) using the HALO Ablation System"
66874|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions
Radiofrequency Ablation (RFA) using the HALO Ablation System"
66875|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions
Radiofrequency Ablation (RFA) using the HALO Ablation System"
66910|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66876|NCT01970787|E1|Reported Event|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions
Radiofrequency Ablation (RFA) using the HALO Ablation System"
66877|NCT01970488|B3|Baseline|Total|Total of all reporting groups
66878|NCT01970488|B2|Baseline|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66879|NCT01970488|B1|Baseline|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66880|NCT01970488|P5|Participant Flow|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66881|NCT01970488|P4|Participant Flow|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66882|NCT01970488|P3|Participant Flow|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66883|NCT01970488|P2|Participant Flow|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66884|NCT01970488|P1|Participant Flow|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66885|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66886|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66887|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66888|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66889|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66890|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66891|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66892|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66893|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66894|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66895|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66896|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66897|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66898|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66899|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66900|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66901|NCT01970488|O5|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66902|NCT01970488|O4|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66903|NCT01970488|O3|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66904|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66905|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66906|NCT01970488|O5|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66907|NCT01970488|O4|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66908|NCT01970488|O3|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66909|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
67011|NCT01969747|P3|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
66911|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66912|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66913|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66914|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66915|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66916|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66917|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66918|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66919|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66920|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66921|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66922|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66923|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66924|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66925|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66926|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66927|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66928|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66929|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66930|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66931|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66932|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66933|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66934|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66935|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66936|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66937|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66938|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66939|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66940|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66941|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66942|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66943|NCT01970488|E5|Reported Event|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
66944|NCT01970488|E4|Reported Event|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
66945|NCT01970488|E3|Reported Event|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
66946|NCT01970488|E2|Reported Event|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66947|NCT01970488|E1|Reported Event|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
66948|NCT01970475|B3|Baseline|Total|Total of all reporting groups
66949|NCT01970475|B2|Baseline|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66950|NCT01970475|B1|Baseline|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66951|NCT01970475|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66952|NCT01970475|P1|Participant Flow|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66953|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66954|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66955|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66956|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66957|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66958|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66959|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66960|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66961|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66962|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66963|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66964|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66965|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66966|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66967|NCT01970475|E2|Reported Event|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66968|NCT01970475|E1|Reported Event|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
66969|NCT01970397|B3|Baseline|Total|Total of all reporting groups
66970|NCT01970397|B2|Baseline|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
66971|NCT01970397|B1|Baseline|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
66972|NCT01970397|P2|Participant Flow|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
68961|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
66973|NCT01970397|P1|Participant Flow|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
66974|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
66975|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
66976|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
66977|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
66978|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
66979|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
66980|NCT01970397|E2|Reported Event|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
66981|NCT01970397|E1|Reported Event|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
66982|NCT01969799|B3|Baseline|Total|Total of all reporting groups
66983|NCT01969799|B2|Baseline|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
67012|NCT01969747|P2|Participant Flow|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
67013|NCT01969747|P1|Participant Flow|Placebo|Placebo tablet; oral administration once daily
94703|NCT01813721|O3|Outcome|Private Center|
66984|NCT01969799|B1|Baseline|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
66985|NCT01969799|P2|Participant Flow|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
66986|NCT01969799|P1|Participant Flow|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
66987|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
66988|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
66989|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
66990|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
66991|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
66992|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
66993|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
66994|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
66995|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
66996|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
66997|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
66998|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
66999|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
67109|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67000|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
67001|NCT01969799|O2|Outcome|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
67002|NCT01969799|O1|Outcome|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
67003|NCT01969799|E2|Reported Event|Aerosolized Placebo|"Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Aerosolized placebo: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System"
67004|NCT01969799|E1|Reported Event|Amikacin Fosfomycin Inhalation Solution|"300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Amikacin fosfomycin inhalation solution: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System"
67005|NCT01969747|B5|Baseline|Total|Total of all reporting groups
67006|NCT01969747|B4|Baseline|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
67007|NCT01969747|B3|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
67008|NCT01969747|B2|Baseline|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
67009|NCT01969747|B1|Baseline|Placebo|Placebo tablet; oral administration once daily
67010|NCT01969747|P4|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
67014|NCT01969747|O4|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
67015|NCT01969747|O3|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
67016|NCT01969747|O2|Outcome|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
67017|NCT01969747|O1|Outcome|Placebo|Placebo tablet; oral administration once daily
67018|NCT01969747|E4|Reported Event|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
67019|NCT01969747|E3|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
67020|NCT01969747|E2|Reported Event|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
67021|NCT01969747|E1|Reported Event|Placebo|Placebo tablet; oral administration once daily
67022|NCT01969721|B1|Baseline|Overall Study|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.
Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.
Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.
Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.
Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.
Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
67023|NCT01969721|P4|Participant Flow|F+S 500/50 / F+S 250/50 / T+O 5/5 / T+O 2.5/5|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.
Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.
Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.
Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.
Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.
Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
67024|NCT01969721|P3|Participant Flow|F+S 250/50 / T+O 2.5/5 / F+S 500/50 / T+O 5/5|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.
Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.
Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.
Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.
Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.
Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
67025|NCT01969721|P2|Participant Flow|T+O 5/5 / F+S 500/50 / T+O 2.5/5 / F+S 250/50|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.
Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.
Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.
Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.
Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.
Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
67026|NCT01969721|P1|Participant Flow|T+O 2.5/5 / T+O 5/5 / F+S 250/50 / F+S 500/50|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled .
Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo (T+O 2.5/5).
Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo (T+O 5/5).
Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo (F+S 250/50).
Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo (F+S 500/50).
Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
67027|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
67028|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
67029|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67030|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67373|NCT01967940|B1|Baseline|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
67031|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
67032|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
67033|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67034|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67035|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
67036|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
67037|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67038|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67039|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
67040|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
67041|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67508|NCT01967147|E1|Reported Event|Pretreatment|All subjects prior to exposure to investigational product
67509|NCT01967121|B4|Baseline|Total|Total of all reporting groups
67042|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67043|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
67044|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
67045|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67046|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67047|NCT01969721|E4|Reported Event|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
69486|NCT01957579|O3|Outcome|8 mg/kg (CLL)|CLL patients in MEDI-551 8 mg/kg cohort
67048|NCT01969721|E3|Reported Event|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
67049|NCT01969721|E2|Reported Event|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67050|NCT01969721|E1|Reported Event|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.
• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
67051|NCT01969565|B1|Baseline|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
Carfilzomib
Dexamethasone"
67052|NCT01969565|P1|Participant Flow|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
Carfilzomib
Dexamethasone"
67053|NCT01969565|O1|Outcome|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
Carfilzomib
Dexamethasone"
67054|NCT01969565|E1|Reported Event|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
Carfilzomib
Dexamethasone"
67055|NCT01969539|B1|Baseline|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
67056|NCT01969539|P1|Participant Flow|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
67057|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
67058|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
67110|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67059|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
67060|NCT01969539|E1|Reported Event|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
67061|NCT01969435|B1|Baseline|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67062|NCT01969435|P1|Participant Flow|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67063|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67064|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67065|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67066|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
69487|NCT01957579|O2|Outcome|4 mg/kg (CLL)|CLL patients in MEDI-551 4 mg/kg cohort
67067|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67068|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67069|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67070|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67071|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67072|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67073|NCT01969435|E1|Reported Event|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion
Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
Day 0, stem cell transplant."
67074|NCT01969162|B1|Baseline|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
67075|NCT01969162|P1|Participant Flow|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
67076|NCT01969162|O1|Outcome|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
67077|NCT01969162|E1|Reported Event|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
67078|NCT01969084|B3|Baseline|Total|Total of all reporting groups
67079|NCT01969084|B2|Baseline|Sugar Pill|"Subjects given sugar pill/placebo
Placebo
Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.
Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasod"
67080|NCT01969084|B1|Baseline|Linagliptin|"Subjects given Linagliptin
Linagliptin
Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.
Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodila"
67081|NCT01969084|P2|Participant Flow|Sugar Pill|"Subjects given sugar pill/placebo
Placebo
Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.
Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasod"
67082|NCT01969084|P1|Participant Flow|Linagliptin|"Subjects given Linagliptin
Linagliptin
Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.
Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodila"
67083|NCT01969084|O2|Outcome|Sugar Pill|Subjects given sugar pill/placebo
67084|NCT01969084|O1|Outcome|Linagliptin|Subjects given Linagliptin
67085|NCT01969084|O2|Outcome|Sugar Pill|Subjects given sugar pill/placebo
67086|NCT01969084|O1|Outcome|Linagliptin|Subjects given Linagliptin
67339|NCT01968434|E2|Reported Event|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic"
67087|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo
Placebo
Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity"
67088|NCT01969084|O1|Outcome|Linagliptin|Linagliptin treated group
67089|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo
Placebo
MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
67090|NCT01969084|O1|Outcome|Linagliptin|"Subjects given Linagliptin
Linagliptin
MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
67091|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo
Placebo
MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
67092|NCT01969084|O1|Outcome|Linagliptin|"Subjects given Linagliptin
Linagliptin
MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
67093|NCT01969084|E2|Reported Event|Sugar Pill|"Subjects given sugar pill/placebo
Placebo"
67094|NCT01969084|E1|Reported Event|Linagliptin|Subjects given Linagliptin
67095|NCT01968980|B3|Baseline|Total|Total of all reporting groups
67096|NCT01968980|B2|Baseline|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67097|NCT01968980|B1|Baseline|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67098|NCT01968980|P2|Participant Flow|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67099|NCT01968980|P1|Participant Flow|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67100|NCT01968980|O1|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67101|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67102|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67103|NCT01968980|O1|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67104|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67105|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67106|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67107|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67108|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67510|NCT01967121|B3|Baseline|Control|This is a control group where subjects will not perform an intervention.
67111|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67112|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67113|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67114|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67115|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67116|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67117|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67118|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67119|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67120|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67371|NCT01967940|B3|Baseline|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
67121|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67122|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67123|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67124|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67125|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67126|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67127|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67128|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67129|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67130|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67131|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67132|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67133|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67134|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67135|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67136|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67137|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67138|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67139|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67140|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67141|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67142|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67143|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67144|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67145|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67146|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67147|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67148|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67149|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67150|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67151|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67152|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67153|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67154|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67155|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67156|NCT01968980|E2|Reported Event|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67157|NCT01968980|E1|Reported Event|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67158|NCT01968967|B3|Baseline|Total|Total of all reporting groups
67159|NCT01968967|B2|Baseline|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67160|NCT01968967|B1|Baseline|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67161|NCT01968967|P2|Participant Flow|Bococizumab (PF­-04950615) 150 Milligram (mg)|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67162|NCT01968967|P1|Participant Flow|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67163|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67164|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67165|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67166|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67167|NCT01968967|O1|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67168|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67169|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67170|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67171|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67172|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67173|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67174|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67175|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67176|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67177|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67178|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67179|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67180|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67181|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67182|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67183|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67184|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67185|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67186|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67187|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67372|NCT01967940|B2|Baseline|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
67188|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67189|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67190|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67191|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67192|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67193|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67194|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67195|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67196|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67197|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67198|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67199|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67200|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67201|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67202|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67203|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67204|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67205|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67206|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67207|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67208|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67209|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67210|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67211|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67212|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67213|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67214|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67215|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67216|NCT01968967|O2|Outcome|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67217|NCT01968967|O1|Outcome|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67218|NCT01968967|E2|Reported Event|Bococizumab (PF­-04950615) 150 mg|Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67219|NCT01968967|E1|Reported Event|Placebo|Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
67220|NCT01968954|B3|Baseline|Total|Total of all reporting groups
67221|NCT01968954|B2|Baseline|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67222|NCT01968954|B1|Baseline|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67223|NCT01968954|P2|Participant Flow|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67224|NCT01968954|P1|Participant Flow|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67225|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67226|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67227|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67228|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67229|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67230|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67231|NCT01968954|O1|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67232|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67233|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67234|NCT01968954|O1|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67235|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67236|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67237|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67238|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67239|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67240|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67241|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67242|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67243|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67244|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67245|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67246|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67247|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67248|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67249|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67250|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67251|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67252|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67253|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67254|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67255|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67256|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67257|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67258|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67259|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67260|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67261|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67262|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67263|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67264|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67265|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67266|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67267|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67268|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67269|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67270|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67271|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67272|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67273|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67274|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67275|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67276|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67277|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67278|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67279|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67280|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67281|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67282|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67283|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67284|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67285|NCT01968954|E2|Reported Event|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67286|NCT01968954|E1|Reported Event|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
67287|NCT01968811|B1|Baseline|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
67288|NCT01968811|P1|Participant Flow|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
67289|NCT01968811|O1|Outcome|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
67290|NCT01968811|O1|Outcome|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
67291|NCT01968811|E1|Reported Event|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
67292|NCT01968694|B3|Baseline|Total|Total of all reporting groups
67293|NCT01968694|B2|Baseline|IV Diphenhydramine Then IV Lidocaine|"IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes."
67294|NCT01968694|B1|Baseline|IV Lidocaine Then IV Diphenhydramine|"IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes."
67295|NCT01968694|P2|Participant Flow|IV Diphenhydramine Then IV Lidocaine|"IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes."
67296|NCT01968694|P1|Participant Flow|IV Lidocaine Then IV Diphenhydramine|"IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes."
67297|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
67298|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
67299|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
67300|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
67301|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
67302|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
67303|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
67304|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
67305|NCT01968694|E4|Reported Event|Washout Period After IV Diphenhydramine|Washout period after IV diphenhydramine before IV Lidocaine
67306|NCT01968694|E3|Reported Event|Washout Period After IV Lidocaine|Washout period after IV Lidocaine before IV diphenhydramine
67307|NCT01968694|E2|Reported Event|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
67308|NCT01968694|E1|Reported Event|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
67309|NCT01968551|B4|Baseline|Total|Total of all reporting groups
67310|NCT01968551|B3|Baseline|Cohort 2: SBR|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67311|NCT01968551|B2|Baseline|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67312|NCT01968551|B1|Baseline|Cohort 1: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67313|NCT01968551|P3|Participant Flow|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67392|NCT01967784|B1|Baseline|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
67314|NCT01968551|P2|Participant Flow|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67315|NCT01968551|P1|Participant Flow|Cohort 1: E/C/F/TAF+DRV|"Open-Label (OL) Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily"
67316|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67317|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67318|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67319|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67320|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67321|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67322|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67323|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TDF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67324|NCT01968551|E4|Reported Event|All E/C/F/TAF|Open- label or Extension Phase: All participants received E/C/F/TAF.
67325|NCT01968551|E3|Reported Event|Cohort 2: SBR|"Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67326|NCT01968551|E2|Reported Event|Cohort 2: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67327|NCT01968551|E1|Reported Event|Cohort 1: E/C/F/TAF+DRV|"Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily"
67328|NCT01968434|B3|Baseline|Total|Total of all reporting groups
67329|NCT01968434|B2|Baseline|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic
Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0"
67330|NCT01968434|B1|Baseline|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum in a syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 6.5 ml three times a day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.
Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0"
67331|NCT01968434|P2|Participant Flow|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic
Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0"
67332|NCT01968434|P1|Participant Flow|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.
Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0"
67333|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic"
67334|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
67335|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic"
67336|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
67337|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic"
67338|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
69488|NCT01957579|O1|Outcome|2 mg/kg (CLL)|CLL patients in MEDI-551 2 mg/kg cohort
67340|NCT01968434|E1|Reported Event|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
67341|NCT01968226|B1|Baseline|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.
[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
67342|NCT01968226|P1|Participant Flow|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.
[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
67343|NCT01968226|O1|Outcome|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.
[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
67344|NCT01968226|E1|Reported Event|PET Imaging With [F-18] RDG-K5|"This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.
[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5"
67345|NCT01968135|B3|Baseline|Total|Total of all reporting groups
67346|NCT01968135|B2|Baseline|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
67347|NCT01968135|B1|Baseline|Sugar Pill|"Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill"
67348|NCT01968135|P2|Participant Flow|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
67349|NCT01968135|P1|Participant Flow|Sugar Pill|"Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill"
67350|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
67351|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill"
67352|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
67353|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill"
67354|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
67355|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill"
67356|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
67357|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill"
67393|NCT01967784|P1|Participant Flow|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
67358|NCT01968135|E2|Reported Event|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
67359|NCT01968135|E1|Reported Event|Sugar Pill|"Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill"
67360|NCT01968057|B1|Baseline|Baricitinib + Ciclosporin|"4 mg baricitinib administered orally on Day 1 of Period 1.
4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2."
67361|NCT01968057|P1|Participant Flow|Baricitinib + Ciclosporin|"4 milligrams (mg) baricitinib administered orally on Day 1 of Period 1.
4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2."
67362|NCT01968057|O2|Outcome|Baricitinib + Ciclosporin|4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
67363|NCT01968057|O1|Outcome|Baricitinib|4 mg baricitinib administered orally on Day 1 of Period 1.
67364|NCT01968057|O2|Outcome|Baricitinib + Ciclosporin|4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
67365|NCT01968057|O1|Outcome|Baricitinib|4 mg baricitinib administered orally on Day 1 of Period 1.
67366|NCT01968057|O2|Outcome|Baricitinib + Ciclosporin|4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
67367|NCT01968057|O1|Outcome|Baricitinib|4 mg baricitinib administered orally on Day 1 of Period 1.
67368|NCT01968057|E2|Reported Event|Baricitinib + Ciclosporin|"4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
Adverse events are reported from postdose on Day 4 up to Day 14."
67369|NCT01968057|E1|Reported Event|Baricitinib|"4 mg baricitinib administered orally on Day 1 of Period 1.
Adverse events are reported from baseline through predose on Day 4."
67370|NCT01967940|B4|Baseline|Total|Total of all reporting groups
69489|NCT01957579|O4|Outcome|12 mg/kg (DLBCL)|DLBCL patients in MEDI-551 12 mg/kg cohort
67374|NCT01967940|P3|Participant Flow|Part 1 Randomized Cohort Placebo, Then Part 2 E/C/F/TAF+ATV|"Part 1: Placebo once daily + their current failing regimen for 10 days
Part 2: Following a 14-day washout period, participants received E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks."
67375|NCT01967940|P2|Participant Flow|Part 1 Randomized Cohort TAF, Then Part 2 E/C/F/TAF+ATV|"Part 1: TAF 25 mg tablet once daily + their current failing regimen for 10 days
Part 2: Following a 14-day washout period, participants who had a > 0.5 log10 decline in HIV-1 RNA received E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks."
67376|NCT01967940|P1|Participant Flow|Part 1 Sentinel Cohort TAF, Then Part 2 E/C/F/TAF+ATV|"Part 1: Tenofovir alafenamide (TAF) 25 mg tablet once daily + their current failing regimen for 10 days
Part 2: Following a 14-day washout period, participants who had a > 0.5 log10 decline in HIV-1 RNA received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) single-tablet regimen (STR) plus atazanavir (ATV) 300 mg once daily for 48 weeks."
67377|NCT01967940|O3|Outcome|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
67378|NCT01967940|O2|Outcome|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
67379|NCT01967940|O1|Outcome|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
67380|NCT01967940|O3|Outcome|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
67381|NCT01967940|O2|Outcome|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
67382|NCT01967940|O1|Outcome|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
67383|NCT01967940|E3|Reported Event|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
67384|NCT01967940|E2|Reported Event|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
67385|NCT01967940|E1|Reported Event|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
67386|NCT01967836|B1|Baseline|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line
Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering"
67387|NCT01967836|P1|Participant Flow|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line
Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering as a means of bathing"
67388|NCT01967836|O1|Outcome|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line
Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering.
Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation
1 subject in ambulatory clinic was approached and was consented
Nurses inspection of central line site on study participants at next clinic visit with return of subject patient questionnaire evaluation of use of product device with showing 27 nurse evaluations were completed for analysis"
67389|NCT01967836|O1|Outcome|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line
Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering.
Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation
1 subject in ambulatory clinic was approached and was consented"
67390|NCT01967836|O1|Outcome|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line
Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering.
Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation
1 subject in ambulatory clinic was approached and was consented"
67391|NCT01967836|E1|Reported Event|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line
Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering as a means of bathing"
67506|NCT01967147|E3|Reported Event|Saline|All subjects exposed to Saline
67394|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
67395|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
67396|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
67397|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
67398|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
67399|NCT01967784|E1|Reported Event|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
67400|NCT01967732|B3|Baseline|Total|Total of all reporting groups
67401|NCT01967732|B2|Baseline|Group 2|"This population comprises the following sequences:
Sequence THS 2.2 then NNS
Sequence NNS then THS 2.2"
67402|NCT01967732|B1|Baseline|Group 1|"This population comprises the following sequences:
Sequence THS 2.2 then CC
Sequence CC then THS 2.2"
67403|NCT01967732|P4|Participant Flow|NNS Then THS 2.2|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single administration of NNS)
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of THS 2.2)."
67404|NCT01967732|P3|Participant Flow|THS 2.2 Then NNS|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of THS 2.2)
Day 2 = wash-out
Day 3 = 2nd intervention (single administration of NNS)"
69490|NCT01957579|O3|Outcome|8 mg/kg (DLBCL)|DLBCL patients in MEDI-551 8 mg/kg cohort
67405|NCT01967732|P2|Participant Flow|CC Then THS 2.2|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of CC)
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of THS 2.2)."
67406|NCT01967732|P1|Participant Flow|THS 2.2 Then CC|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of THS 2.2)
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of CC)."
67407|NCT01967732|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence THS 2.2 then NNS
Sequence NNS then THS 2.2"
67408|NCT01967732|O3|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence THS 2.2 then NNS
Sequence NNS then THS 2.2"
67409|NCT01967732|O2|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence THS 2.2 then CC
Sequence CC then THS 2.2"
67410|NCT01967732|O1|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence THS 2.2 then CC
Sequence CC then THS 2.2"
67411|NCT01967732|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence THS 2.2 then NNS
Sequence NNS then THS 2.2"
67412|NCT01967732|O3|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence THS 2.2 then NNS
Sequence NNS then THS 2.2"
67413|NCT01967732|O2|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence THS 2.2 then CC
Sequence CC then THS 2.2"
67414|NCT01967732|O1|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence THS 2.2 then CC
Sequence CC then THS 2.2"
67415|NCT01967732|E2|Reported Event|Group 2|"This population comprises the following sequences:
Sequence THS 2.2 then NNS
Sequence NNS then THS 2.2"
67416|NCT01967732|E1|Reported Event|Group 1|"This population comprises the following sequences:
Sequence THS 2.2 then CC
Sequence CC then THS 2.2"
67417|NCT01967719|B3|Baseline|Total|Total of all reporting groups
67418|NCT01967719|B2|Baseline|Group 2|"This population comprises the following sequences:
Sequence mTHS 2.2 then NNS
Sequence NNS then mTHS 2.2"
67419|NCT01967719|B1|Baseline|Group 1|"This population comprises the following sequences:
Sequence mTHS 2.2 then mCC
Sequence mCC then mTHS 2.2"
67420|NCT01967719|P4|Participant Flow|NNS Then mTHS 2.2|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single administration of NNS)
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of mTHS 2.2)."
67421|NCT01967719|P3|Participant Flow|mTHS 2.2 Then NNS|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of mTHS 2.2)
Day 2 = wash-out
Day 3 = 2nd intervention (single administration of NNS)"
67422|NCT01967719|P2|Participant Flow|mCC Then mTHS 2.2|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of mCC)
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of mTHS 2.2)."
67423|NCT01967719|P1|Participant Flow|mTHS 2.2 Then mCC|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of mTHS 2.2)
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of mCC)."
67424|NCT01967719|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence mTHS 2.2 then NNS
Sequence NNS then mTHS 2.2"
67425|NCT01967719|O3|Outcome|mTHS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence mTHS 2.2 then NNS
Sequence NNS then mTHS 2.2"
67426|NCT01967719|O2|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence mTHS 2.2 then mCC
Sequence mCC then mTHS 2.2"
67427|NCT01967719|O1|Outcome|mTHS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence mTHS 2.2 then mCC
Sequence mCC then mTHS 2.2."
67428|NCT01967719|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence mTHS 2.2 then NNS
Sequence NNS then mTHS 2.2"
67429|NCT01967719|O3|Outcome|mTHS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence mTHS 2.2 then NNS
Sequence NNS then mTHS 2.2"
67430|NCT01967719|O2|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence mTHS 2.2 then mCC
Sequence mCC then mTHS 2.2"
67431|NCT01967719|O1|Outcome|mTHS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
Sequence mTHS 2.2 then mCC
Sequence mCC then mTHS 2.2"
67432|NCT01967719|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the mTHS 2.2 at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
67433|NCT01967719|E2|Reported Event|Group 2|"This population comprises the following sequences:
Sequence mTHS 2.2 then NNS
Sequence NNS then mTHS 2.2"
67434|NCT01967719|E1|Reported Event|Group 1|"This population comprises the following sequences:
Sequence mTHS 2.2 then mCC
Sequence mCC then mTHS 2.2"
67435|NCT01967706|B3|Baseline|Total|Total of all reporting groups
67436|NCT01967706|B2|Baseline|Group 2|"This population comprises the following sequences:
Sequence mTHS then NRT
Sequence NRT then mTHS"
67437|NCT01967706|B1|Baseline|Group 1|"This population comprises the following sequences:
Sequence mTHS then mCC
Sequence mCC then mTHS"
67438|NCT01967706|P4|Participant Flow|NRT Then mTHS|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single administration of NRT)
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of mTHS)."
67439|NCT01967706|P3|Participant Flow|mTHS Then NRT|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of mTHS)
Day 2 = wash-out
Day 3 = 2nd intervention (single administration of NRT)"
67440|NCT01967706|P2|Participant Flow|mCC Then mTHS|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of mCC)
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of mTHS)."
67441|NCT01967706|P1|Participant Flow|mTHS Then mCC|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of mTHS)
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of mCC)."
67442|NCT01967706|O2|Outcome|Ratio mTHS:NRT|"This population comprises the following sequences:
Sequence mTHS then NRT
Sequence NRT then mTHS"
67443|NCT01967706|O1|Outcome|Ratio mTHS:mCC|"This population comprises the following sequences:
Sequence mTHS then mCC
Sequence mCC then mTHS."
67444|NCT01967706|O2|Outcome|Ratio mTHS:NRT|"This population comprises the following sequences:
Sequence mTHS then NRT
Sequence NRT then mTHS"
67445|NCT01967706|O1|Outcome|Ratio mTHS:mCC|"This population comprises the following sequences:
Sequence mTHS then mCC
Sequence mCC then mTHS"
67446|NCT01967706|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the mTHS at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
67447|NCT01967706|E2|Reported Event|Group 2|"This population comprises the following sequences:
Sequence mTHS then NRT
Sequence NRT then mTHS"
67448|NCT01967706|E1|Reported Event|Group 1|"This population comprises the following sequences:
Sequence mTHS then mCC
Sequence mCC then mTHS"
67449|NCT01967550|B3|Baseline|Total|Total of all reporting groups
67450|NCT01967550|B2|Baseline|Placebo|Vehicle control
67451|NCT01967550|B1|Baseline|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel
diclofenac diethylamine, DDEA 2.32% gel"
67452|NCT01967550|P2|Participant Flow|Placebo|Vehicle control
67453|NCT01967550|P1|Participant Flow|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel
diclofenac diethylamine, DDEA 2.32% gel"
67454|NCT01967550|O2|Outcome|Placebo|Vehicle control
67455|NCT01967550|O1|Outcome|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel
diclofenac diethylamine, DDEA 2.32% gel"
67456|NCT01967550|E2|Reported Event|Placebo|Vehicle control
67457|NCT01967550|E1|Reported Event|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel
diclofenac diethylamine, DDEA 2.32% gel"
67458|NCT01967342|B4|Baseline|Total|Total of all reporting groups
67459|NCT01967342|B3|Baseline|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67460|NCT01967342|B2|Baseline|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67461|NCT01967342|B1|Baseline|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
67462|NCT01967342|P3|Participant Flow|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67463|NCT01967342|P2|Participant Flow|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67464|NCT01967342|P1|Participant Flow|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
67465|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67481|NCT01967277|B2|Baseline|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
67602|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67466|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67467|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
67468|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67469|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67470|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
67471|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67472|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67473|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
67474|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67475|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67507|NCT01967147|E2|Reported Event|Systane Balance|All subjects exposed to Systane® Balance
67476|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
67477|NCT01967342|E3|Reported Event|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67478|NCT01967342|E2|Reported Event|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
67479|NCT01967342|E1|Reported Event|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
67480|NCT01967277|B3|Baseline|Total|Total of all reporting groups
69491|NCT01957579|O2|Outcome|4 mg/kg (DLBCL)|DLBCL patients in MEDI-551 4 mg/kg cohort
67482|NCT01967277|B1|Baseline|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
67483|NCT01967277|P2|Participant Flow|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
67484|NCT01967277|P1|Participant Flow|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
67485|NCT01967277|O2|Outcome|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
67486|NCT01967277|O1|Outcome|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
67487|NCT01967277|O2|Outcome|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
67488|NCT01967277|O1|Outcome|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
67489|NCT01967277|E2|Reported Event|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
67490|NCT01967277|E1|Reported Event|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
67491|NCT01967147|B3|Baseline|Total|Total of all reporting groups
67492|NCT01967147|B2|Baseline|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67493|NCT01967147|B1|Baseline|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67494|NCT01967147|P2|Participant Flow|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67495|NCT01967147|P1|Participant Flow|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67496|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67497|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67498|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67499|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67500|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67501|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67502|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67503|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67504|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67505|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
67511|NCT01967121|B2|Baseline|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).
Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
67512|NCT01967121|B1|Baseline|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.
Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
67513|NCT01967121|P3|Participant Flow|Control|This is a control group where subjects will not perform an intervention.
67514|NCT01967121|P2|Participant Flow|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).
Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
67515|NCT01967121|P1|Participant Flow|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.
Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
67516|NCT01967121|O3|Outcome|Control|This is a control group where subjects will not perform an intervention.
67517|NCT01967121|O2|Outcome|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).
Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
94704|NCT01813721|O2|Outcome|General Hospital|
67518|NCT01967121|O1|Outcome|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.
Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
67519|NCT01967121|E3|Reported Event|Control|This is a control group where subjects will not perform an intervention.
67520|NCT01967121|E2|Reported Event|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).
Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
67521|NCT01967121|E1|Reported Event|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.
Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
67522|NCT01967069|B3|Baseline|Total|Total of all reporting groups
67523|NCT01967069|B2|Baseline|Vehicle Spray|"Vehicle Spray twice daily
Vehicle Spray"
67524|NCT01967069|B1|Baseline|DFD01 Spray|"DFD01 Spray twice daily
DFD01 Spray"
67525|NCT01967069|P2|Participant Flow|Vehicle Spray|"Vehicle Spray twice daily
Vehicle Spray"
67526|NCT01967069|P1|Participant Flow|DFD01 Spray|"DFD01 Spray twice daily
DFD01 Spray"
67527|NCT01967069|O2|Outcome|Vehicle Spray|"Vehicle Spray twice daily
Vehicle Spray"
67528|NCT01967069|O1|Outcome|DFD01 Spray|"DFD01 Spray twice daily
DFD01 Spray"
67529|NCT01967069|E2|Reported Event|Vehicle Spray|"Vehicle Spray twice daily
Vehicle Spray"
67530|NCT01967069|E1|Reported Event|DFD01 Spray|"DFD01 Spray twice daily
DFD01 Spray"
67531|NCT01966926|B3|Baseline|Total|Total of all reporting groups
67532|NCT01966926|B2|Baseline|Weekly Weight Tracking|weekly weighing frequency instructions and tips
67533|NCT01966926|B1|Baseline|Daily Weight Tracking|daily weighing frequency instructions and tips
67534|NCT01966926|P2|Participant Flow|Weekly Weight Tracking|weekly weighing frequency instructions and tips
67535|NCT01966926|P1|Participant Flow|Daily Weight Tracking|daily weighing frequency instructions and tips
67536|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
67537|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
67538|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
67539|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
67540|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
67541|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
67542|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
67543|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
67544|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
67545|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
67546|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
67547|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
67548|NCT01966926|E2|Reported Event|Weekly Weight Tracking|weekly weighing frequency instructions and tips
67549|NCT01966926|E1|Reported Event|Daily Weight Tracking|daily weighing frequency instructions and tips
67550|NCT01966770|B1|Baseline|Overall Study Group|All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
67551|NCT01966770|P1|Participant Flow|Overall Study Group|All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
67552|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67553|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67554|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67555|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67556|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67557|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67558|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67559|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67560|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67561|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67562|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67563|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67564|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67565|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67566|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67567|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
67568|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
67569|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67570|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67571|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67572|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67573|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67574|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67575|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67576|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67577|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67578|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67579|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67580|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67581|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67582|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67583|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67584|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67585|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67586|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67587|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67588|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67589|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67590|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67591|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67592|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67593|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67594|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67595|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67596|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67597|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67598|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67599|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67600|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67601|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67603|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67604|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67605|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67606|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
67607|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
67608|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
67609|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67610|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67611|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67612|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67613|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67614|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67615|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
67616|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
67617|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67618|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
67619|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
67620|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67621|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67622|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67623|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67624|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67625|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67626|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67855|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67627|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67628|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67629|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67630|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67631|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67632|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
67633|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67634|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67635|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67636|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67637|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67638|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67639|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67640|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
67641|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67642|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
67643|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67644|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
67645|NCT01966770|O7|Outcome|F55 ASPHERE LENS|Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
67646|NCT01966770|O6|Outcome|F55 SPHERE LENS|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
67647|NCT01966770|O5|Outcome|PCM SPHERE LENS|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
67648|NCT01966770|O4|Outcome|AV SPHERE LENS|Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
67649|NCT01966770|O3|Outcome|BF SPHERE LENS|Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
67650|NCT01966770|O2|Outcome|B55 SPHERE LENS|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
67651|NCT01966770|O1|Outcome|B55 PREMIER ASPHERE LENS|Subjects wore contralateral lenses. Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
67652|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
67653|NCT01966770|E6|Reported Event|Pair 6 (Omafilcon A / Comfilcon A)|Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
67654|NCT01966770|E5|Reported Event|Pair 5 (Methafilcon A / Comfilcon A)|Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
67655|NCT01966770|E4|Reported Event|Pair 4 (Methafilcon A / Methafilcon A)|Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
67656|NCT01966770|E3|Reported Event|Pair 3 (Ocufilcon D / Comfilcon A)|Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
67657|NCT01966770|E2|Reported Event|Pair 2 (Ocufilcon D / Enfilcon A)|Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
67658|NCT01966770|E1|Reported Event|Pair 1 (Ocufilcon D / Ocufilcon D)|Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
67659|NCT01966718|B1|Baseline|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks
Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
67660|NCT01966718|P1|Participant Flow|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks
Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
67683|NCT01966432|O3|Outcome|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
67661|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks
Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
67662|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks
Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
67663|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks
Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
67664|NCT01966718|O2|Outcome|Tender Joints|Change in number of tender joints exhibited at week 16, calculated by subtracting week 16 total from baseline total.
67665|NCT01966718|O1|Outcome|Swollen Joints|Change in number of swollen joints participants exhibited at week 16 (Calculated by subtracting week 16 total from baseline total. Positive numbers indicate number at week 16 was less than at baseline).
67666|NCT01966718|E1|Reported Event|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks
Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
67667|NCT01966432|B4|Baseline|Total|Total of all reporting groups
67668|NCT01966432|B3|Baseline|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
67669|NCT01966432|B2|Baseline|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67670|NCT01966432|B1|Baseline|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67671|NCT01966432|P3|Participant Flow|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
67672|NCT01966432|P2|Participant Flow|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67673|NCT01966432|P1|Participant Flow|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67674|NCT01966432|O3|Outcome|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
67675|NCT01966432|O2|Outcome|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67676|NCT01966432|O1|Outcome|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67677|NCT01966432|O3|Outcome|S Group|Screening group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
67678|NCT01966432|O2|Outcome|SBI Group|"Screening, Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67679|NCT01966432|O1|Outcome|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67680|NCT01966432|O3|Outcome|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
67681|NCT01966432|O2|Outcome|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67682|NCT01966432|O1|Outcome|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67856|NCT01965652|E2|Reported Event|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67684|NCT01966432|O2|Outcome|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67685|NCT01966432|O1|Outcome|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67686|NCT01966432|O3|Outcome|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
67687|NCT01966432|O2|Outcome|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67688|NCT01966432|O1|Outcome|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67689|NCT01966432|E3|Reported Event|S Group|Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
67690|NCT01966432|E2|Reported Event|SBI Group|"Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
68554|NCT01963403|O2|Outcome|Placebo|"Placebo
Placebo: 1 pill per day; daily during study participation (up to 84 days)"
67691|NCT01966432|E1|Reported Event|SBIRT Group|"Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits."
67692|NCT01966380|B1|Baseline|Leia and Hydroactive Surgical Dressing|In the case of this study, participants served as their own control.
67693|NCT01966380|P2|Participant Flow|Cross-over Assignment Hydroactive Surgical Dressing|First intervention Hydroactive surgical dressing 5 Days, then second intervention Leia, 5 Days..
67694|NCT01966380|P1|Participant Flow|Cross-over Assignment Leia|First intervention Leia, 5 Days, then second intervention Hydroactive surgical dressing 5 Days.
67695|NCT01966380|O2|Outcome|Hydroactivate Surgical Dressing|Intervention: Device, Hydroactivate surgical dressing. Cross-over design, the patient was his own controll. 6 patients were treated in total.
67696|NCT01966380|O1|Outcome|Leia|Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.
67697|NCT01966380|E2|Reported Event|Hydroactive Surgical Dressing|"Intervention: Device: Hydroactive surgical dressing
Cross-over design, the patient was his own controll. 6 patients were treated in total."
67698|NCT01966380|E1|Reported Event|Leia|Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.
67699|NCT01966354|B4|Baseline|Total|Total of all reporting groups
67700|NCT01966354|B3|Baseline|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67701|NCT01966354|B2|Baseline|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67702|NCT01966354|B1|Baseline|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67731|NCT01966159|P1|Participant Flow|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
67732|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
67733|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
67857|NCT01965652|E1|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67703|NCT01966354|P3|Participant Flow|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67704|NCT01966354|P2|Participant Flow|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67771|NCT01966068|E1|Reported Event|MyAsthma Web Portal|"The portal, MyAsthma, will provide asthma education, collect patient-reported outcomes, evaluate medication use and side effects, and track parents' concerns and goals. Parents will log into the web portal each month, and the information entered by parents will be shared through the electronic health record with the child's primary care provider.
MyAsthma Web Portal"
68402|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
67705|NCT01966354|P1|Participant Flow|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67706|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67707|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67708|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67709|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67710|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67734|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
67735|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
67736|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
67711|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67712|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
69492|NCT01957579|O1|Outcome|2 mg/kg (DLBCL)|DLBCL patients in MEDI-551 2 mg/kg cohort
67713|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67714|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67715|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67716|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67717|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67718|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67737|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
67738|NCT01966159|E2|Reported Event|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
67739|NCT01966159|E1|Reported Event|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
67740|NCT01966120|B3|Baseline|Total|Total of all reporting groups
67719|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67720|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
94705|NCT01813721|O1|Outcome|University Hospital|
67721|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67722|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67723|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67724|NCT01966354|E3|Reported Event|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Oblique axis, in-plane needle:
Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67725|NCT01966354|E2|Reported Event|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach
Short axis, out-of-plane needle:
Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67726|NCT01966354|E1|Reported Event|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach
Long axis, in-plane needle:
Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.
Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
67727|NCT01966159|B3|Baseline|Total|Total of all reporting groups
67728|NCT01966159|B2|Baseline|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
67729|NCT01966159|B1|Baseline|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
67730|NCT01966159|P2|Participant Flow|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
67741|NCT01966120|B2|Baseline|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67780|NCT01965938|B2|Baseline|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67781|NCT01965938|B1|Baseline|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
68813|NCT01961349|E1|Reported Event|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
67742|NCT01966120|B1|Baseline|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67743|NCT01966120|P2|Participant Flow|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67744|NCT01966120|P1|Participant Flow|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the investigational medicinal product (IMP) was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67745|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67746|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67747|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67748|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67767|NCT01966068|B1|Baseline|MyAsthma Web Portal Sustained Use|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
67749|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
94706|NCT01813721|O2|Outcome|> 10 Years|
67750|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67751|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67752|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67753|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67754|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67755|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67756|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
68172|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
67757|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
94707|NCT01813721|O1|Outcome|≤ 10 Years|
67758|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67759|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67760|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67761|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67762|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67763|NCT01966120|E2|Reported Event|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67764|NCT01966120|E1|Reported Event|BF-200 ALA|"Photodynamic therapy with BF-200 ALA
After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.
Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
67765|NCT01966068|B3|Baseline|Total|Total of all reporting groups
67766|NCT01966068|B2|Baseline|MyAsthma Web Portal Adoption|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once
67768|NCT01966068|P1|Participant Flow|MyAsthma Web Portal|The portal, MyAsthma, provided asthma education, collected patient-reported outcomes, evaluated medication use and side effects, and tracked parents' concerns and goals. Parents logged into the web portal each month, and the information entered by parents was shared through the electronic health record with the child's primary care provider.
67769|NCT01966068|O2|Outcome|MyAsthma Portal Adoption|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once.
67770|NCT01966068|O1|Outcome|MyAsthma Web Portal Sustained Use|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
68182|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
67772|NCT01966042|B1|Baseline|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.
Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.
Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.
Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.
Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
67773|NCT01966042|P1|Participant Flow|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and autologous bone marrow mononuclear cells infusion.
Local sedation: All subjects enrolled underwent local sedation for bone marrow aspiration.
Bone Marrow Aspiration: All subjects enrolled underwent bone marrow aspiration after anesthesia from the posterior iliac crest. The sample was aspirated into sterile syringes and brought to the cell processing laboratory. The processing was in accordance to the Standard Operating Procedure developed observing Good Practice Guidelines.
Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated.
Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened, the surgeon drew up the cells into syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
67774|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.
Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.
Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.
Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.
Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
67775|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.
Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.
Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.
Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.
Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
67776|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.
Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.
Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.
Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.
Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
67777|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.
Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.
Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.
Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.
Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
67797|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
67778|NCT01966042|E1|Reported Event|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.
Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.
Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.
Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.
Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
67779|NCT01965938|B3|Baseline|Total|Total of all reporting groups
68183|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
67782|NCT01965938|P2|Participant Flow|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67783|NCT01965938|P1|Participant Flow|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67784|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
67785|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
67786|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67787|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67788|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67789|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67790|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67791|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67792|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67793|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67794|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
67795|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
67796|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
67798|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67799|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67800|NCT01965938|E2|Reported Event|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67801|NCT01965938|E1|Reported Event|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
67873|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67802|NCT01965899|B1|Baseline|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
67803|NCT01965899|P1|Participant Flow|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
67804|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
67805|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
67806|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from the automatically detected arrhythmias. Documentation of episode occurrence will be retained.
67807|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
67808|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
67809|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
67810|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
67811|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
67812|NCT01965899|E1|Reported Event|Insertable Cardiac Monitor Implant|The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
67813|NCT01965834|B1|Baseline|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
67814|NCT01965834|P1|Participant Flow|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
67815|NCT01965834|O1|Outcome|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
67816|NCT01965834|O1|Outcome|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
67908|NCT01965561|O3|Outcome|JETT|Use of Junctional Emergency Treatment Tool (JETT)
67909|NCT01965561|O2|Outcome|AAJT|Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
67910|NCT01965561|O1|Outcome|CRoC|Use of Combat Ready Clamp (CRoC)
67817|NCT01965834|O1|Outcome|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
67818|NCT01965834|E1|Reported Event|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
67819|NCT01965665|B1|Baseline|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.
MediHoney HCS dressing"
67820|NCT01965665|P1|Participant Flow|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.
MediHoney HCS dressing"
67821|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.
MediHoney HCS dressing"
67822|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.
MediHoney HCS dressing"
67823|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.
MediHoney HCS dressing"
67824|NCT01965665|E1|Reported Event|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.
MediHoney HCS dressing"
67825|NCT01965652|B3|Baseline|Total|Total of all reporting groups
67826|NCT01965652|B2|Baseline|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67827|NCT01965652|B1|Baseline|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67828|NCT01965652|P2|Participant Flow|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67829|NCT01965652|P1|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67830|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67831|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67832|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67833|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67834|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67835|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67836|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67837|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67838|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67839|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67840|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67841|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67842|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67843|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67844|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67845|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67846|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67847|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67848|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67849|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67850|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67851|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67852|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67853|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
67854|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
67858|NCT01965600|B1|Baseline|All Participants|Participants received PF-06282999 125 mg TID or 500 mg BID or matching placebo orally in tablet form from Days 1 to 3. On Day 3, participants received a dose of LPS as an IV bolus at a dose of 4 ng/kg over 45-60 secs 2 hours after the morning dose of PF-06282999 or matching placebo. A final dose of PF-06282999 or matching placebo was administered on the evening of Day 3. Period 2 started after a washout period of approximately 15 days with at least 21 days in between administration of LPS. Participants who took active treatment (PF-06282999) in Period 1 received placebo in Period 2 and vice versa.
67911|NCT01965561|O4|Outcome|SJT Tourniquet|SAM Junctional Tourniquet (SJT)
67912|NCT01965561|O3|Outcome|JETT|Use of Junctional Emergency Treatment Tool (JETT)
67913|NCT01965561|O2|Outcome|AAJT|Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
67914|NCT01965561|O1|Outcome|CRoC|Use of Combat Ready Clamp (CRoC)
67859|NCT01965600|P4|Participant Flow|Placebo Followed by PF-06282999 500 mg BID|Participants received placebo orally via tablets. Placebo matching PF-06282999 500 mg BID were administered on Days 1-3 at 8am and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 500 mg BID in the same manner as placebo in the first period.
67860|NCT01965600|P3|Participant Flow|PF-06282999 500 mg BID Followed by Placebo|Participants received PF-06282999 500 milligrams (mg) twice daily (BID) orally in tablet form from Days 1 to 3 (8am and 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
67861|NCT01965600|P2|Participant Flow|Placebo Followed by PF-06282999 125 mg TID|Participants received placebo orally via tablets. Placebo matching PF-06282999 125 mg TID were administered on Days 1-3 at approximately 8am, 2pm, and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 125 mg TID in the same manner as placebo in the first period.
67862|NCT01965600|P1|Participant Flow|PF-06282999 125 mg TID Followed by Placebo|Participants received PF-06282999 125 milligrams (mg) three times daily (TID) orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
67863|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67864|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67865|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67866|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67867|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67868|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67869|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67870|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67871|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
68173|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
67872|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67915|NCT01965561|E1|Reported Event|Junctional Tourniquet Use|Junctional tourniquet use followed by rest, repeat.
67916|NCT01965535|B3|Baseline|Total|Total of all reporting groups
67874|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67875|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67876|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67877|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67878|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67879|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67880|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67881|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67882|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67883|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67884|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67885|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67886|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67887|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67888|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67889|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67890|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67891|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67892|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67893|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67894|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67895|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67896|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67897|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67898|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67899|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67900|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67901|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67902|NCT01965600|E3|Reported Event|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
67903|NCT01965600|E2|Reported Event|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
67904|NCT01965600|E1|Reported Event|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
67905|NCT01965561|B1|Baseline|Junctional Tourniquet Use|"Junctional tourniquet use followed by rest, repeat
Rest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is an bladder within a belt. CRC is a vice."
67906|NCT01965561|P1|Participant Flow|Junctional Tourniquet Use|Junctional tourniquet use followed by rest, repeat.
67907|NCT01965561|O4|Outcome|SJT Tourniquet|SAM Junctional Tourniquet (SJT)
67917|NCT01965535|B2|Baseline|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
67918|NCT01965535|B1|Baseline|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
67919|NCT01965535|P2|Participant Flow|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
67920|NCT01965535|P1|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus placebo to match ribavirin (RBV) in a divided daily dose for 24 weeks
67921|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
67922|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
67923|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
67924|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
67925|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
67926|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
67927|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
67928|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
67929|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
67930|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
67931|NCT01965535|E2|Reported Event|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
67932|NCT01965535|E1|Reported Event|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
67933|NCT01965431|B1|Baseline|Overall Study|This study is randomised, single-blind, 3-period crossover having 3 treatments, BI 207127 and Faldaprevir for 3 days (Days -2 to 1), placebo to BI 207127 plus placebo to Faldaprevir for 3 days (Days -2 to 1) and Moxifloxacin 400 mg as single dose (Day 1).
67934|NCT01965431|P6|Participant Flow|R2/R1/T|Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
67935|NCT01965431|P5|Participant Flow|R2/T/R1|Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered on as single dose on day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
67936|NCT01965431|P4|Participant Flow|R1/R2/T|Patients were treated in the morning with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
69493|NCT01957579|O4|Outcome|12 mg/kg (FL)|FL patients in MEDI-551 12 mg/kg cohort
67937|NCT01965431|P3|Participant Flow|R1/T/R2|Patients were treated with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2):Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
67938|NCT01965431|P2|Participant Flow|T/R2/R1|Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
67939|NCT01965431|P1|Participant Flow|T/R1/R2|Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) twice daily (bid) were administered on day -2 and day -1 and 600 mg once daily (qd) on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg once daily (qd) on day -1 and day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2) : Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
67940|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
67941|NCT01965431|O1|Outcome|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
67942|NCT01965431|O2|Outcome|Placebo to BI 207127) + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
67943|NCT01965431|O1|Outcome|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
67944|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
67945|NCT01965431|O1|Outcome|Moxifloxacin|Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day 1 with 240 mL of water.
67946|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
67947|NCT01965431|O1|Outcome|BI 207127+ Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
67968|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67948|NCT01965431|E3|Reported Event|Placebo (BI 207127) + Placebo (Faldaprevir)|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.
67949|NCT01965431|E2|Reported Event|Moxifloxacin|Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day1 with 240 mL of water.
67950|NCT01965431|E1|Reported Event|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.
67951|NCT01965327|B1|Baseline|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
67973|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68403|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
67952|NCT01965327|P1|Participant Flow|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
67953|NCT01965327|O1|Outcome|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
67954|NCT01965327|O1|Outcome|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
67955|NCT01965327|E1|Reported Event|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
67956|NCT01965288|B3|Baseline|Total|Total of all reporting groups
67957|NCT01965288|B2|Baseline|Lotrafilcon B Then Comfilcon A|All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67958|NCT01965288|B1|Baseline|Comfilcon A Then Lotrafilcon B|All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67959|NCT01965288|P2|Participant Flow|Lotrafilcon B Then Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67960|NCT01965288|P1|Participant Flow|Comfilcon A Then Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67961|NCT01965288|O3|Outcome|Neither|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67962|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67963|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67964|NCT01965288|O3|Outcome|Habitual|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67965|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67966|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67967|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67969|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67970|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67971|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67972|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68404|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
67974|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67975|NCT01965288|O2|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67976|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67977|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67978|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67979|NCT01965288|O2|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67980|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67981|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67982|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67983|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67984|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67985|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67986|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67987|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
67988|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67989|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67990|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67991|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67992|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68389|NCT01964352|P1|Participant Flow|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
67993|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67994|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67995|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67996|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67997|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67998|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
67999|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68000|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
68001|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68002|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68003|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68004|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68005|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
68006|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68007|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68008|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68009|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68010|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
68011|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68012|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68013|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68014|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68015|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
68016|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68017|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68018|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68019|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68020|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68021|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68022|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68023|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68024|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68025|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68026|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68027|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68028|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68029|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68030|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68031|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68032|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68033|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68034|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68035|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68036|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68037|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68038|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68039|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68040|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68041|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68042|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68043|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68044|NCT01965288|O2|Outcome|Lotrafilcon B|Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
68045|NCT01965288|O1|Outcome|Comfilcon A|Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
68046|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68047|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68048|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68049|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68050|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68051|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68052|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68053|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68054|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68055|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68056|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68057|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68058|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68059|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68060|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68061|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68062|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68063|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68064|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68065|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68066|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68067|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68068|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68069|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
68070|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68071|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68072|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68073|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68074|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68075|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68076|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68077|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68078|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68079|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68080|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68081|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68082|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68083|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68084|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68085|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68086|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68087|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68088|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68089|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68090|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68091|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.A)
68092|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68093|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68094|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68095|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68096|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68097|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68098|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68099|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68100|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68101|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68102|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68103|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.A)
68104|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68105|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68106|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
68107|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68108|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68109|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68110|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68111|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68112|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68113|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68114|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68115|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68116|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68117|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68118|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68119|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68120|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68121|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68122|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68123|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68124|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68125|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68126|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68127|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68128|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68129|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68130|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68131|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68132|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68133|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68134|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68135|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68136|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68137|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68138|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68139|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68140|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68141|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68142|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68143|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68144|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68145|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68146|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68147|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68148|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68149|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68150|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68151|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68152|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68153|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68154|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68155|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68156|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68157|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68158|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68159|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68160|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68161|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects after removal of habitual lens and prior to dispense of study lens.
68162|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
68163|NCT01965288|E2|Reported Event|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
68164|NCT01965288|E1|Reported Event|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
68165|NCT01965262|B1|Baseline|Overall Baseline Characteristics|"Randomized to wear the Hema-copolymer lens pair or the etafilcon A lens pair for one week then cross over to the alternate pair
Hema-copolymer Lens: Hema-copolymer lens pair or the Etafilcon A lens pair
etafilcon A Lens: Hema-copolymer lens pair or the Etafilcon A lens pair"
68166|NCT01965262|P2|Participant Flow|Etafilcon A Lens, Then Hema-copoloymer Lens|Participants were randomized to wear the etafilcon A lens pair for one week then cross over to the Hema-copolymer lens lens pair.
68167|NCT01965262|P1|Participant Flow|Hema-copolymer Lens, Then Etafilcon A Lens|Participants were randomized to wear the Hema-copolymer lens pair for one week then cross over to the etafilcon A lens pair.
68168|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68169|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68170|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68171|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68174|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68175|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68176|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68177|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68178|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68179|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68180|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68181|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68184|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68185|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68186|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68187|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68188|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68189|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68190|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68191|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68192|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68193|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68194|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68195|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68196|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68197|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68198|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68199|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68200|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68201|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68202|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68203|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68204|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68205|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68206|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68207|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68208|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68209|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68210|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68962|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
68211|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68212|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68213|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68214|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68215|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68216|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68217|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68218|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68219|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68220|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68221|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68222|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68223|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68224|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68225|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68226|NCT01965262|E2|Reported Event|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
etafilcon A lens: contact lens"
68227|NCT01965262|E1|Reported Event|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Hema-copolymer: contact lens"
68228|NCT01965158|B3|Baseline|Total|Total of all reporting groups
68229|NCT01965158|B2|Baseline|Placebo|Participants received placebo orally once daily for 12 weeks.
68230|NCT01965158|B1|Baseline|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
68231|NCT01965158|P2|Participant Flow|Placebo|Participants received placebo orally once daily for 12 weeks.
68232|NCT01965158|P1|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
68233|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
68234|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
68235|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
68236|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
68237|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
68238|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
68239|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
68240|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
68241|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
68242|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
68243|NCT01965158|E2|Reported Event|Placebo|Participants received placebo orally once daily for 12 weeks.
68244|NCT01965158|E1|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
68245|NCT01965067|B3|Baseline|Total|Total of all reporting groups
68246|NCT01965067|B2|Baseline|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68247|NCT01965067|B1|Baseline|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68248|NCT01965067|P2|Participant Flow|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68249|NCT01965067|P1|Participant Flow|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68250|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68251|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68390|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68252|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68253|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68254|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68255|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68256|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68257|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68258|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68259|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68260|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68261|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68262|NCT01965067|E2|Reported Event|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68263|NCT01965067|E1|Reported Event|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C
sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state"
68264|NCT01964976|B3|Baseline|Total|Total of all reporting groups
68265|NCT01964976|B2|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68266|NCT01964976|B1|Baseline|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68267|NCT01964976|P1|Participant Flow|All Population|All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with biguanide or without biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68268|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
68269|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
68270|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
68271|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
68272|NCT01964976|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68273|NCT01964976|O1|Outcome|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68274|NCT01964976|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68275|NCT01964976|O1|Outcome|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68276|NCT01964976|E2|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68277|NCT01964976|E1|Reported Event|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68278|NCT01964950|B3|Baseline|Total|Total of all reporting groups
68279|NCT01964950|B2|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68280|NCT01964950|B1|Baseline|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68281|NCT01964950|P1|Participant Flow|All Population (Alogliptin)|All participants who received alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months along with an SU or without an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68282|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
68283|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
68284|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
68285|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
68405|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
68286|NCT01964950|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68287|NCT01964950|O1|Outcome|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68288|NCT01964950|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68289|NCT01964950|O1|Outcome|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68290|NCT01964950|E2|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68291|NCT01964950|E1|Reported Event|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
68292|NCT01964898|B3|Baseline|Total|Total of all reporting groups
68293|NCT01964898|B2|Baseline|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation"
68294|NCT01964898|B1|Baseline|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
68295|NCT01964898|P2|Participant Flow|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation"
68296|NCT01964898|P1|Participant Flow|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
68321|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68322|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68297|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation"
68298|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
68329|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68299|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation"
68300|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
68301|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation"
68302|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
68303|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation"
68304|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
68305|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation"
68306|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
68307|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation"
68308|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
68309|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation"
68310|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
68311|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation"
68312|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
68313|NCT01964898|E2|Reported Event|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation"
68314|NCT01964898|E1|Reported Event|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
68315|NCT01964716|B3|Baseline|Total|Total of all reporting groups
68316|NCT01964716|B2|Baseline|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68317|NCT01964716|B1|Baseline|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68318|NCT01964716|P2|Participant Flow|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68319|NCT01964716|P1|Participant Flow|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68320|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68323|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68324|NCT01964716|O3|Outcome|Screened Only|Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
68325|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68326|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68327|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68328|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68330|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68331|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68332|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68333|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68334|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68335|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68336|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68337|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68338|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68339|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68340|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68341|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68342|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68343|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
68344|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
68345|NCT01964716|E9|Reported Event|Screened Only|Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
68346|NCT01964716|E8|Reported Event|13vPnC SDS: After Dose 3|Participants who received all three 0.5mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
68347|NCT01964716|E7|Reported Event|13vPnC MDV: After Dose 3|Participants who received all three 0.5mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
68348|NCT01964716|E6|Reported Event|13vPnC SDS: After Dose 2|Participants who received two 0.5 mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
68349|NCT01964716|E5|Reported Event|13vPnC MDV: After Dose 2|Participants who received two 0.5 mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
68350|NCT01964716|E4|Reported Event|13vPnC SDS: After Dose 1|Participants who received single 0.5 mL dose of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
68963|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
68351|NCT01964716|E3|Reported Event|13vPnC MDV: After Dose 1|Participants who received single 0.5 mL dose of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
68352|NCT01964716|E2|Reported Event|13vPnC SDS: Informed Consent to Dose 1|Participants who were randomized to receive 13vPnC (PF-05208760) SDS at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
68353|NCT01964716|E1|Reported Event|13vPnC MDV: Informed Consent to Dose 1|Participants who were randomized to receive 13vPnC (PF-06414256) MDV at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
68354|NCT01964547|B3|Baseline|Total|Total of all reporting groups
68355|NCT01964547|B2|Baseline|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68356|NCT01964547|B1|Baseline|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68357|NCT01964547|P2|Participant Flow|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68358|NCT01964547|P1|Participant Flow|Sativex|Each 100 μl actuation contains delta-9-tetrahydrocannabinol (THC) (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
94708|NCT01813721|O2|Outcome|Hematologist|
68359|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68360|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68361|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68362|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68363|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68364|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68365|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68366|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68367|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68368|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68369|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68370|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68371|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68372|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68373|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68374|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68375|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68376|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68377|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68378|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68379|NCT01964547|E2|Reported Event|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
68380|NCT01964547|E1|Reported Event|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
68381|NCT01964352|B5|Baseline|Total|Total of all reporting groups
68382|NCT01964352|B4|Baseline|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68383|NCT01964352|B3|Baseline|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68384|NCT01964352|B2|Baseline|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
68385|NCT01964352|B1|Baseline|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
68386|NCT01964352|P4|Participant Flow|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68387|NCT01964352|P3|Participant Flow|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68388|NCT01964352|P2|Participant Flow|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
68391|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68392|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
68393|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
68394|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68395|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68396|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
68397|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
68398|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68399|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68400|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
68401|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
94709|NCT01813721|O1|Outcome|Medical Oncologist|
68406|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68407|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68408|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
68409|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
68410|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68411|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68412|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
68413|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
68414|NCT01964352|E4|Reported Event|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68415|NCT01964352|E3|Reported Event|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
68416|NCT01964352|E2|Reported Event|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
68417|NCT01964352|E1|Reported Event|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
68418|NCT01964326|B1|Baseline|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
68419|NCT01964326|P1|Participant Flow|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
68420|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
68421|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
68422|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
68423|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
68424|NCT01964326|E1|Reported Event|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
68425|NCT01964222|B3|Baseline|Total|Total of all reporting groups
68426|NCT01964222|B2|Baseline|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
68427|NCT01964222|B1|Baseline|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
68428|NCT01964222|P2|Participant Flow|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
68429|NCT01964222|P1|Participant Flow|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
68430|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
68431|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
68432|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
68433|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
68434|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
68435|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
68436|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
68437|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
68438|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
68439|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
68440|NCT01964222|E2|Reported Event|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
68472|NCT01963676|B1|Baseline|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.
tDCS"
68441|NCT01964222|E1|Reported Event|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
68442|NCT01963845|B3|Baseline|Total|Total of all reporting groups
68443|NCT01963845|B2|Baseline|Active Drug|Sitagliptin 100 mg
68444|NCT01963845|B1|Baseline|Placebo|Sitagliptin-matched placebo tablet
68445|NCT01963845|P2|Participant Flow|Active Drug|Sitagliptin 100 mg
68446|NCT01963845|P1|Participant Flow|Placebo|Sitagliptin-matched placebo tablet
68447|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg
Sitagliptin"
68448|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
68449|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg
Sitagliptin"
68450|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
68451|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg
Sitagliptin"
68452|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
68453|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg
Sitagliptin"
68454|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
68455|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg
Sitagliptin"
68456|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
68457|NCT01963845|E2|Reported Event|Active Drug|Sitagliptin 100 mg
68458|NCT01963845|E1|Reported Event|Placebo|Sitagliptin-matched placebo tablet
68459|NCT01963767|B3|Baseline|Total|Total of all reporting groups
68460|NCT01963767|B2|Baseline|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
68461|NCT01963767|B1|Baseline|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.
NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent."
68462|NCT01963767|P2|Participant Flow|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
68463|NCT01963767|P1|Participant Flow|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.
NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent."
68464|NCT01963767|O2|Outcome|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
68465|NCT01963767|O1|Outcome|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.
NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.
Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*
Vaccinium angustifolium"
68466|NCT01963767|O2|Outcome|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
68500|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68501|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68502|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
68467|NCT01963767|O1|Outcome|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.
NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.
Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*
Vaccinium angustifolium"
68468|NCT01963767|E2|Reported Event|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
68469|NCT01963767|E1|Reported Event|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.
NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.
Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*
Vaccinium angustifolium"
68470|NCT01963676|B3|Baseline|Total|Total of all reporting groups
68471|NCT01963676|B2|Baseline|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Sham stimulation"
94710|NCT01813721|O4|Outcome|France|
68473|NCT01963676|P2|Participant Flow|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Sham stimulation"
68474|NCT01963676|P1|Participant Flow|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.
tDCS"
68475|NCT01963676|O2|Outcome|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Sham stimulation"
68476|NCT01963676|O1|Outcome|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.
tDCS"
68477|NCT01963676|O2|Outcome|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Sham stimulation"
68478|NCT01963676|O1|Outcome|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.
tDCS"
68479|NCT01963676|E2|Reported Event|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Sham stimulation"
68480|NCT01963676|E1|Reported Event|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.
tDCS"
68481|NCT01963611|B6|Baseline|Total|Total of all reporting groups
68482|NCT01963611|B5|Baseline|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
68483|NCT01963611|B4|Baseline|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68484|NCT01963611|B3|Baseline|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68485|NCT01963611|B2|Baseline|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68486|NCT01963611|B1|Baseline|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68487|NCT01963611|P5|Participant Flow|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
68488|NCT01963611|P4|Participant Flow|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68489|NCT01963611|P3|Participant Flow|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68490|NCT01963611|P2|Participant Flow|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68491|NCT01963611|P1|Participant Flow|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68492|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
68493|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68494|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68495|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68496|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68497|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
68498|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68499|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68503|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68504|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68505|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68506|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68507|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months
68508|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68509|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68510|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68511|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68512|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
68513|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68514|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
94711|NCT01813721|O3|Outcome|Romania|
68515|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68516|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68517|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
68518|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68519|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68520|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68521|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68522|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
68523|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68524|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68525|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68526|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68527|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
68528|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68529|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68530|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68531|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68532|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
68533|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68534|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68535|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68536|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68537|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
68538|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
68539|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68540|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68964|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
68541|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
68542|NCT01963611|E5|Reported Event|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for a minimum of 40 weeks.
68543|NCT01963611|E4|Reported Event|Plovamer Acetate 20 mg|Plovamer acetate was administered at a dose of 20 mg as weekly subcutaneous injection for a minimum of 40 weeks.
68544|NCT01963611|E3|Reported Event|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for a minimum of 40 weeks.
68545|NCT01963611|E2|Reported Event|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for a minimum of 40 weeks.
68546|NCT01963611|E1|Reported Event|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for a minimum of 40 weeks.
68547|NCT01963403|B3|Baseline|Total|Total of all reporting groups
68548|NCT01963403|B2|Baseline|Placebo|"Placebo
Placebo: 1 pill per day; daily during study participation (up to 84 days)"
68549|NCT01963403|B1|Baseline|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)
EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
68550|NCT01963403|P2|Participant Flow|Placebo|"Placebo
Placebo: 1 pill per day; daily during study participation (up to 84 days)"
68551|NCT01963403|P1|Participant Flow|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)
EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
68552|NCT01963403|O2|Outcome|No Use of COC at Any Time During 3 Months|
68553|NCT01963403|O1|Outcome|Used COC at Any Time During 3 Months|
68555|NCT01963403|O1|Outcome|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)
EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
68556|NCT01963403|O2|Outcome|Placebo|"Placebo
Placebo: 1 pill per day; daily during study participation (up to 84 days)"
68557|NCT01963403|O1|Outcome|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)
EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
68558|NCT01963403|O2|Outcome|Placebo|"Placebo
Placebo: 1 pill per day; daily during study participation (up to 84 days)"
68559|NCT01963403|O1|Outcome|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)
EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
68560|NCT01963403|E2|Reported Event|Placebo|Placebo: 1 pill per day; daily during study participation (up to 84 days)
68561|NCT01963403|E1|Reported Event|EE 30mcg/LNG 150mcg|"Combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)
EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
68562|NCT01963260|B11|Baseline|Total|Total of all reporting groups
68563|NCT01963260|B10|Baseline|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
68564|NCT01963260|B9|Baseline|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
68565|NCT01963260|B8|Baseline|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
68566|NCT01963260|B7|Baseline|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
68567|NCT01963260|B6|Baseline|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
68568|NCT01963260|B5|Baseline|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68569|NCT01963260|B4|Baseline|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68570|NCT01963260|B3|Baseline|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68571|NCT01963260|B2|Baseline|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68572|NCT01963260|B1|Baseline|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68573|NCT01963260|P10|Participant Flow|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
68574|NCT01963260|P9|Participant Flow|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants with ITP from Part 2 MK-8723 10 mg/kg were re-enrolled into Part 2 100 mg/kg and dosed (not shown).
68575|NCT01963260|P8|Participant Flow|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
68576|NCT01963260|P7|Participant Flow|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with immune thrombocytopenia purpura (ITP) in Part 2. 2 participants were subsequently enrolled in Part 2 MK-8723 100 mg/kg.
68577|NCT01963260|P6|Participant Flow|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
68578|NCT01963260|P5|Participant Flow|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68579|NCT01963260|P4|Participant Flow|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68580|NCT01963260|P3|Participant Flow|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68581|NCT01963260|P2|Participant Flow|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68582|NCT01963260|P1|Participant Flow|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68583|NCT01963260|O8|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
68584|NCT01963260|O7|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
68585|NCT01963260|O6|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
68586|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68587|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68588|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68589|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68590|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68811|NCT01961349|E3|Reported Event|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
68591|NCT01963260|O8|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
68592|NCT01963260|O7|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
68593|NCT01963260|O6|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
68594|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68595|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68596|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68597|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68598|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68599|NCT01963260|O4|Outcome|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
68600|NCT01963260|O3|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
68601|NCT01963260|O2|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
68602|NCT01963260|O1|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
68603|NCT01963260|O10|Outcome|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
68604|NCT01963260|O9|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
68605|NCT01963260|O8|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
68606|NCT01963260|O7|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
68607|NCT01963260|O6|Outcome|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
68608|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68609|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68610|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68611|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68612|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68613|NCT01963260|O10|Outcome|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
68614|NCT01963260|O9|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
68615|NCT01963260|O8|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
68965|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
68616|NCT01963260|O7|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
68617|NCT01963260|O6|Outcome|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
68618|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68619|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68620|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68621|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68622|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68623|NCT01963260|E10|Reported Event|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
68624|NCT01963260|E9|Reported Event|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
68625|NCT01963260|E8|Reported Event|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
68626|NCT01963260|E7|Reported Event|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
68627|NCT01963260|E6|Reported Event|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
68628|NCT01963260|E5|Reported Event|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68629|NCT01963260|E4|Reported Event|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68630|NCT01963260|E3|Reported Event|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68631|NCT01963260|E2|Reported Event|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68632|NCT01963260|E1|Reported Event|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
68633|NCT01963143|B4|Baseline|Total|Total of all reporting groups
68634|NCT01963143|B3|Baseline|Pediatrics|Gammaplex 10 on a 21 or 28 day schedule
68635|NCT01963143|B2|Baseline|Treatment Sequence 2 - Adults|Gammaplex 5% and Gammaplex 10 on a 28-day schedule
68636|NCT01963143|B1|Baseline|Treatment Sequence 1 - Adults|Gammaplex 5% and Gammaplex 10 on a 21-day schedule
68637|NCT01963143|P3|Participant Flow|Pediatrics|Gammaplex 10 on a 21 or 28 day treatment schedule
68638|NCT01963143|P2|Participant Flow|Treatment Sequence 2 - Adults|Gammaplex 10 and Gammaplex 5% on a 28-day treatment schedule
68639|NCT01963143|P1|Participant Flow|Treatment Sequence 1 - Adults|Gammaplex 5% & Gammaplex 10 on a 21-day treatment schedule
68640|NCT01963143|O2|Outcome|Gammaplex 5%|
68641|NCT01963143|O1|Outcome|Gammaplex 10%|
68642|NCT01963143|O2|Outcome|Gammaplex 5%|
68643|NCT01963143|O1|Outcome|Gammaplex 10%|
68644|NCT01963143|O2|Outcome|Gammaplex 5%|
68645|NCT01963143|O1|Outcome|Gammaplex 10%|
68646|NCT01963143|E2|Reported Event|Gammaplex 10% - All Subjects|Subjects aged 2-55 years
68647|NCT01963143|E1|Reported Event|Gammaplex 5% - All Subjects|Subjects aged 17-55 years
68648|NCT01963091|B3|Baseline|Total|Total of all reporting groups
68649|NCT01963091|B2|Baseline|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68650|NCT01963091|B1|Baseline|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68651|NCT01963091|P2|Participant Flow|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68652|NCT01963091|P1|Participant Flow|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68769|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
72661|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
68653|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68654|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68655|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68656|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68812|NCT01961349|E2|Reported Event|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
68657|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68658|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68659|NCT01963091|E2|Reported Event|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68660|NCT01963091|E1|Reported Event|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
68661|NCT01962974|B1|Baseline|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
68662|NCT01962974|P1|Participant Flow|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
68663|NCT01962974|O1|Outcome|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
68664|NCT01962974|O1|Outcome|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
68665|NCT01962974|O1|Outcome|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
68666|NCT01962974|E1|Reported Event|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
68667|NCT01962961|B4|Baseline|Total|Total of all reporting groups
68668|NCT01962961|B3|Baseline|Placebo|"Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68669|NCT01962961|B2|Baseline|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
68681|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
68670|NCT01962961|B1|Baseline|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68671|NCT01962961|P3|Participant Flow|Placebo|"Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68672|NCT01962961|P2|Participant Flow|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
68777|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
68673|NCT01962961|P1|Participant Flow|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68674|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68675|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
68676|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68677|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68678|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
68679|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68680|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68727|NCT01962493|B2|Baseline|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68682|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68683|NCT01962961|E3|Reported Event|Placebo|"Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68684|NCT01962961|E2|Reported Event|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
94712|NCT01813721|O2|Outcome|Greece|
68685|NCT01962961|E1|Reported Event|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
68686|NCT01962922|B3|Baseline|Total|Total of all reporting groups
68687|NCT01962922|B2|Baseline|Sequence II|Sequence II Envarsus XR→IR-Tac (N = 23)
68688|NCT01962922|B1|Baseline|Sequence I|Sequence I IR-Tac→Envarsus XR (N = 27)
68689|NCT01962922|P2|Participant Flow|Sequence 2|"• Sequence II: (n=23) 1 Patients receive Envarsus XR tablets (at 15% lower dose than their IR-Tac dose) on Days 1–7 (24-hour PK profile on Day 7), then patients are switched back to twice-daily Tac - IR treatment beginning on Day 8. PK on days 14 and 21.
Patients in sequence 2 are on Tac - IR at Day 21. Patient have option of continuing in extension portion of the study on Tac - IR for up to 6 months."
68690|NCT01962922|P1|Participant Flow|Sequence 1|"•Sequence I: (n=27) Patients will continue on twice-daily IR-Tac capsules on Days 1–7 (24-hour PK profile on Day 7), then patients are switched to Envarsus XR tablets (at a dose 15% lower than their Tac - IR doses) on Day 8. PK on day 14 and 21.
Patients in sequence 1 are on Envarsus XR at Day 21. Patient may continue on extension up to a total of 6 months."
68691|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
68692|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
68693|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
68694|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
68695|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
68696|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
68697|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
68698|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
68699|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
68700|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
68701|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
68702|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
68703|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
68704|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
68705|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
68706|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
68707|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
68708|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
68709|NCT01962922|E2|Reported Event|Tacrolimus - IR|brand IR tacrolimus
68710|NCT01962922|E1|Reported Event|Envarsus XR|Tacrolimus extended release
68711|NCT01962675|B3|Baseline|Total|Total of all reporting groups
68712|NCT01962675|B2|Baseline|Sham tDCS - Real tDCS|"Sham tDCS+skilled training
Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles
Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles"
68713|NCT01962675|B1|Baseline|Real tDCS - Sham tDCS|"Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles
Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles"
68714|NCT01962675|P2|Participant Flow|Sham tDCS - Real tDCS|"Sham tDCS+skilled training
Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles
Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles"
68715|NCT01962675|P1|Participant Flow|Real tDCS - Sham tDCS|"Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles
Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles"
68778|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
68779|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
94713|NCT01813721|O1|Outcome|Poland|
68716|NCT01962675|O2|Outcome|Sham tDCS - Real tDCS|"Sham tDCS+skilled training
Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles
Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles"
68717|NCT01962675|O1|Outcome|Real tDCS - Sham tDCS|"Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles
Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles"
68718|NCT01962675|O2|Outcome|Sham tDCS - Real tDCS|"Sham tDCS+skilled training
Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles
Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles"
68719|NCT01962675|O1|Outcome|Real tDCS - Sham tDCS|"Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles
Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles"
68720|NCT01962675|O2|Outcome|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
68721|NCT01962675|O1|Outcome|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
68722|NCT01962675|O2|Outcome|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
68723|NCT01962675|O1|Outcome|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
68724|NCT01962675|E2|Reported Event|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
68725|NCT01962675|E1|Reported Event|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
68726|NCT01962493|B3|Baseline|Total|Total of all reporting groups
68767|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
68866|NCT01960725|B2|Baseline|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68728|NCT01962493|B1|Baseline|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68729|NCT01962493|P2|Participant Flow|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68730|NCT01962493|P1|Participant Flow|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68731|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68732|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68733|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68734|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68735|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68736|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68737|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68738|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68739|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68740|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68741|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68742|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68768|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
68743|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68744|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68745|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
94714|NCT01813721|O2|Outcome|General Hospital|
68746|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68747|NCT01962493|E2|Reported Event|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68748|NCT01962493|E1|Reported Event|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
68749|NCT01962441|B4|Baseline|Total|Total of all reporting groups
68750|NCT01962441|B3|Baseline|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
68751|NCT01962441|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
68752|NCT01962441|B1|Baseline|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
68753|NCT01962441|P3|Participant Flow|SOF+RBV+Peg-IFN 12 Weeks|"Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks
Participants in this group were not eligible to enroll into the Retreatment Period."
68754|NCT01962441|P2|Participant Flow|SOF+RBV 24 Weeks, Then Retreatment|"Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks."
68755|NCT01962441|P1|Participant Flow|SOF+RBV 16 Weeks, Then Retreatment|"Randomized Period: Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks."
68756|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
68757|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
68758|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
68759|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
68760|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
68761|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
68762|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
68763|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
68764|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
68765|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
68766|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
68770|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
68771|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
68772|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
68773|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
68774|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
68775|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
68776|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
68780|NCT01962441|E4|Reported Event|Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks|Retreatment Period: Participants from the SOF+RBV 16 Weeks or 24 Weeks groups who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks.
68781|NCT01962441|E3|Reported Event|Randomized Period: SOF+RBV+Peg-IFN 12 Weeks|Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
68782|NCT01962441|E2|Reported Event|Randomized Period: SOF+RBV 24 Weeks|Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
68783|NCT01962441|E1|Reported Event|Randomized Period: SOF+RBV 16 Weeks|Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
68784|NCT01962428|B3|Baseline|Total|Total of all reporting groups
68785|NCT01962428|B2|Baseline|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
68786|NCT01962428|B1|Baseline|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
68787|NCT01962428|P2|Participant Flow|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
68788|NCT01962428|P1|Participant Flow|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
68789|NCT01962428|O2|Outcome|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
68790|NCT01962428|O1|Outcome|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
68791|NCT01962428|E2|Reported Event|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
68792|NCT01962428|E1|Reported Event|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
68793|NCT01961544|B1|Baseline|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
68794|NCT01961544|P1|Participant Flow|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
68795|NCT01961544|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
68796|NCT01961544|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
68867|NCT01960725|B1|Baseline|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68797|NCT01961544|E1|Reported Event|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2-5 minutes on Day 1 and Day 8 of each 21-day cycle.
68798|NCT01961349|B4|Baseline|Total|Total of all reporting groups
68799|NCT01961349|B3|Baseline|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
68800|NCT01961349|B2|Baseline|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
68801|NCT01961349|B1|Baseline|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
68802|NCT01961349|P3|Participant Flow|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
68803|NCT01961349|P2|Participant Flow|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
68804|NCT01961349|P1|Participant Flow|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
68805|NCT01961349|O3|Outcome|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
68806|NCT01961349|O2|Outcome|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
68807|NCT01961349|O1|Outcome|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
68808|NCT01961349|O3|Outcome|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
68809|NCT01961349|O2|Outcome|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
68810|NCT01961349|O1|Outcome|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
69494|NCT01957579|O3|Outcome|8 mg/kg (FL)|FL patients in MEDI-551 8 mg/kg cohort
68814|NCT01961271|B1|Baseline|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.
Buprenorphine transdermal patch: Please see Arm Description."
68815|NCT01961271|P1|Participant Flow|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.
Buprenorphine transdermal patch: Please see Arm Description."
68816|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.
Buprenorphine transdermal patch: Please see Arm Description."
68817|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.
Buprenorphine transdermal patch: Please see Arm Description."
68818|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.
Buprenorphine transdermal patch: Please see Arm Description."
68819|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.
Buprenorphine transdermal patch: Please see Arm Description."
68820|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.
Buprenorphine transdermal patch: Please see Arm Description."
68821|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.
Buprenorphine transdermal patch: Please see Arm Description."
68822|NCT01961271|E1|Reported Event|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.
Buprenorphine transdermal patch: Please see Arm Description."
68823|NCT01960907|B3|Baseline|Total|Total of all reporting groups
68824|NCT01960907|B2|Baseline|Interventional|"Patients received a system for monitoring their health status.
The system is composed by:
a touch-screen pc for the administration of daily questionnaires
RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern
a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.
Subjects received additional medical treatment following the activation of alarms by the monitoring devices.
Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
68825|NCT01960907|B1|Baseline|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.
They followed their usual care path as provided by their local NHS"
68826|NCT01960907|P2|Participant Flow|Interventional|"Patients received a system for monitoring their health status.
The system is composed by:
a touch-screen pc for the administration of daily questionnaires
RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern
a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.
Subjects received medical treatment following the activation of alarms by the monitoring devices.
Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
68827|NCT01960907|P1|Participant Flow|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.
They followed their usual care path as provided by their local NHS."
68828|NCT01960907|O2|Outcome|Observational, Previously Hopitalized for COPD Exacerb.|Patients in the observational group that were hospitalized the year before the study for a COPD exacerbation
68829|NCT01960907|O1|Outcome|Monitored, Previously Hopitalized for COPD Exacerbation|Patients in the monitored group that were hospitalized the year before the study for a COPD exacerbation
68830|NCT01960907|O2|Outcome|Interventional|"Patients received a system for monitoring their health status.
The system is composed by:
a touch-screen pc for the administration of daily questionnaires
RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern
a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.
Subjects received additional medical treatment following the activation of alarms by the monitoring devices.
Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
68831|NCT01960907|O1|Outcome|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.
They followed their usual care path as provided by their local NHS."
68832|NCT01960907|O2|Outcome|Interventional|"Patients received a system for monitoring their health status.
The system is composed by:
a touch-screen pc for the administration of daily questionnaires
RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern
a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.
Subjects received additional medical treatment following the activation of alarms by the monitoring devices.
Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
68833|NCT01960907|O1|Outcome|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.
They followed their usual care path as provided by their local NHS"
68878|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68879|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68880|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68834|NCT01960907|E2|Reported Event|Interventional|"Patients received a system for monitoring their health status.
The system is composed by:
a touch-screen pc for the administration of daily questionnaires
RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern
a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.
Subjects received additional medical treatment following the activation of alarms by the monitoring devices.
Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
68835|NCT01960907|E1|Reported Event|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.
They followed their usual care path as provided by their local NHS"
68836|NCT01960842|B1|Baseline|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68837|NCT01960842|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68838|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68839|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68840|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68841|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68868|NCT01960725|P2|Participant Flow|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68842|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68843|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68881|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68882|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68883|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
94715|NCT01813721|O1|Outcome|University Hospital|
68844|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68845|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68846|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68847|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68848|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68849|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68850|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68851|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68869|NCT01960725|P1|Participant Flow|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68852|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68853|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
94716|NCT01813721|O2|Outcome|> 10 Years|
68854|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68855|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68856|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68857|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68858|NCT01960842|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
68859|NCT01960816|B1|Baseline|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway
Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
68860|NCT01960816|P1|Participant Flow|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway
Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
68861|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway
Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
68862|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway
Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
68863|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway
Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
68864|NCT01960816|E1|Reported Event|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway
Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
68865|NCT01960725|B3|Baseline|Total|Total of all reporting groups
68870|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68871|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68872|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68873|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68874|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68875|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68876|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68877|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
69255|NCT01958619|B4|Baseline|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
68884|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68885|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68886|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68887|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68888|NCT01960725|E2|Reported Event|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68889|NCT01960725|E1|Reported Event|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age
RV5 (Pentavalent Rotavirus Vaccine)"
68890|NCT01960530|B1|Baseline|All Participants|All participants received no IMP, dexamethasone (non-IMP), oral infacort, oral hydrocortisone, i.v. hydrocortisone
68891|NCT01960530|P1|Participant Flow|5-period Crossover|"Study Period 1 (Endogenous Cortisol): No IMP was administered. Subjects were observed over a 24 hour period, during which sleep disruption was minimised, to record their endogenous cortisol production as a baseline figure and to confirm eligibility for the subsequent study periods.
Study Period 2 (Dexamethasone): Subjects were admitted to the unit following a final confirmation of eligibility, prior to administration with Dexamethasone.
Study Periods 3 and 4 (Infacort Granules or Hydrocortisone Tablets): Subjects were admitted to the unit and ongoing eligibility was confirmed. Subjects received both treatments (1 in Period 3, and 1 in Period 4), and were randomised using the PROC PLAN procedure of SAS. Subjects received Dexamethasone 1 hour prior to IMP administration.
Study Period 5 (I.V. Hydrocortisone Injection): Subjects were admitted to the unit and ongoing eligibility was confirmed. Subjects received Dexamethasone 1 hour prior to IMP administration."
68892|NCT01960530|O3|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
i.v. Hydrocortisone Injection"
68893|NCT01960530|O2|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Hydrocortisone Tablet"
68894|NCT01960530|O1|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Infacort"
68895|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
i.v. Hydrocortisone Injection"
68896|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Hydrocortisone Tablet"
68897|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Infacort"
68954|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
68898|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Dexamethasone"
68899|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
68900|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
i.v. Hydrocortisone Injection"
68901|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Hydrocortisone Tablet"
68902|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Infacort"
68903|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Dexamethasone"
69480|NCT01957579|P1|Participant Flow|2 mg/kg|MEDI-551 2 mg/kg
68904|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
68905|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
i.v. Hydrocortisone Injection"
68906|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Hydrocortisone Tablet"
68907|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Infacort"
68908|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Dexamethasone"
68909|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
68910|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
i.v. Hydrocortisone Injection"
68911|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Hydrocortisone Tablet"
68912|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Infacort"
68913|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Dexamethasone"
68914|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
68915|NCT01960530|O3|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
i.v. Hydrocortisone Injection"
68916|NCT01960530|O2|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Hydrocortisone Tablet"
68955|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
68917|NCT01960530|O1|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Infacort"
68918|NCT01960530|E5|Reported Event|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
i.v. Hydrocortisone Injection"
68919|NCT01960530|E4|Reported Event|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Hydrocortisone Tablet"
68920|NCT01960530|E3|Reported Event|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Infacort"
68921|NCT01960530|E2|Reported Event|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Dexamethasone"
94717|NCT01813721|O1|Outcome|≤ 10 Years|
68922|NCT01960530|E1|Reported Event|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
68923|NCT01960400|B3|Baseline|Total|Total of all reporting groups
68924|NCT01960400|B2|Baseline|GMI + Sham TDCS|"Graded motor imagery (GMI) + sham tDCS
tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
68925|NCT01960400|B1|Baseline|GMI + tDCS|"Graded motor imagery (GMI) + tDCS
tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
68926|NCT01960400|P2|Participant Flow|GMI + Sham TDCS|"Graded motor imagery (GMI) + sham tDCS
tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
68927|NCT01960400|P1|Participant Flow|GMI + tDCS|"Graded motor imagery (GMI) + tDCS
tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
68928|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).
tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
68929|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.
tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
68930|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).
tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
68956|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
68957|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
68958|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
68959|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
68960|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
68931|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.
tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
68932|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).
tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
68933|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.
tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
94718|NCT01813721|O1|Outcome|Medical Oncologist|
68934|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).
tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
68935|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.
tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
68936|NCT01960400|E2|Reported Event|GMI + Placebo tDCS|Graded motor imagery (GMI) + placebo tDCS
68937|NCT01960400|E1|Reported Event|GMI + Active tDCS|Graded motor imagery (GMI) + active tDCS
68938|NCT01960387|B1|Baseline|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
68939|NCT01960387|P1|Participant Flow|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
68940|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
68941|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
68942|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
68943|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
68944|NCT01960387|E1|Reported Event|Clofarabine (40mg/m2/Day) + Cytarabine (1g/m2/Day)|Patients with Newly Diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m2 daily plus cytarabine at a dose of 1g/m2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration, on days 1 through 5.
68945|NCT01960296|B3|Baseline|Total|Total of all reporting groups
68946|NCT01960296|B2|Baseline|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
68947|NCT01960296|B1|Baseline|Clopidogrel|Continue home dose of clopidogrel into surgery
68948|NCT01960296|P2|Participant Flow|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
68949|NCT01960296|P1|Participant Flow|Clopidogrel|Continue home dose of clopidogrel into surgery
68950|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
68951|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
68952|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
68953|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
68966|NCT01960296|E2|Reported Event|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
68967|NCT01960296|E1|Reported Event|Clopidogrel|Continue home dose of clopidogrel into surgery
68968|NCT01960140|B1|Baseline|Simvastatin Then Baricitinib and Simvastatin|"Period 1: 40-mg tablet of simvastatin administered orally on Day 1.
Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6."
68969|NCT01960140|P1|Participant Flow|Simvastatin Then Baricitinib and Simvastatin|"Period 1: 40-milligram (mg) tablet of simvastatin administered orally on Day 1.
Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally once daily (QD) on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6."
68970|NCT01960140|O2|Outcome|Baricitinib and Simvastatin|Period 2: 10-mg dose of Baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.
68971|NCT01960140|O1|Outcome|Simvastatin|Period 1: 40-mg tablet of simvastatin administered orally on Day 1.
68972|NCT01960140|O2|Outcome|Baricitinib and Simvastatin|Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.
68973|NCT01960140|O1|Outcome|Simvastatin|Period 1: 40-mg tablet of simvastatin administered orally on Day 1.
68974|NCT01960140|E3|Reported Event|Baricitinib and Simvastatin|"A 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 6 and 7, with coadministration of 40-mg simvastatin tablet on Day 6.
AEs are reported postdose on Day 6 up to Day 18."
69081|NCT01959607|B2|Baseline|Group 2|"This population comprises the following sequences:
Sequence THS 2.2 then NRT
Sequence NRT then THS 2.2"
68975|NCT01960140|E2|Reported Event|Baricitinib|"A 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 5.
AEs are reported postdose on Day 3 through predose on Day 6."
68976|NCT01960140|E1|Reported Event|Simvastatin|"A 40-mg tablet of simvastatin administered orally on Day 1.
Adverse events (AEs) are reported from baseline through predose on Day 3."
68977|NCT01960114|B3|Baseline|Total|Total of all reporting groups
68978|NCT01960114|B2|Baseline|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
68979|NCT01960114|B1|Baseline|Placebo|Placebo (two matching placebo tablets)
68980|NCT01960114|P2|Participant Flow|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
68981|NCT01960114|P1|Participant Flow|Placebo|Placebo (two matching placebo tablets)
68982|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
68983|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
68984|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
68985|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
68986|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
68987|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
68988|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
68989|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
68990|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
68991|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
68992|NCT01960114|E2|Reported Event|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
68993|NCT01960114|E1|Reported Event|Placebo|Placebo (two matching placebo tablets)
68994|NCT01959945|B5|Baseline|Total|Total of all reporting groups
68995|NCT01959945|B4|Baseline|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
68996|NCT01959945|B3|Baseline|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
68997|NCT01959945|B2|Baseline|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
68998|NCT01959945|B1|Baseline|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
68999|NCT01959945|P4|Participant Flow|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69000|NCT01959945|P3|Participant Flow|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69001|NCT01959945|P2|Participant Flow|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69002|NCT01959945|P1|Participant Flow|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69003|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69004|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69005|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69044|NCT01959932|E2|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
69006|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69007|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69008|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69009|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69010|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69011|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69012|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69082|NCT01959607|B1|Baseline|Group 1|"This population comprises the following sequences:
Sequence THS 2.2 then CC
Sequence CC then THS 2.2"
69013|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69014|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69015|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69016|NCT01959945|O3|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69017|NCT01959945|O2|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69018|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69019|NCT01959945|E4|Reported Event|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69020|NCT01959945|E3|Reported Event|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69021|NCT01959945|E2|Reported Event|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69022|NCT01959945|E1|Reported Event|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
69023|NCT01959932|B4|Baseline|Total|Total of all reporting groups
69024|NCT01959932|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
69025|NCT01959932|B2|Baseline|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
69026|NCT01959932|B1|Baseline|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
69027|NCT01959932|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
69028|NCT01959932|P2|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
69029|NCT01959932|P1|Participant Flow|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
69030|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
69031|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
69032|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
69033|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
69034|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
69035|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
69036|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
69037|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
69038|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
69039|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
69040|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
69041|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
69042|NCT01959932|E4|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects
69043|NCT01959932|E3|Reported Event|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
69045|NCT01959932|E1|Reported Event|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
69046|NCT01959880|B5|Baseline|Total|Total of all reporting groups
69047|NCT01959880|B4|Baseline|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
69048|NCT01959880|B3|Baseline|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
69049|NCT01959880|B2|Baseline|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
69050|NCT01959880|B1|Baseline|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
69051|NCT01959880|P4|Participant Flow|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
69113|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant"
69052|NCT01959880|P3|Participant Flow|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
69053|NCT01959880|P2|Participant Flow|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
69054|NCT01959880|P1|Participant Flow|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
69055|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
69056|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
69057|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
69058|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
69059|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
69060|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
69061|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
69062|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
69063|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
69064|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
69065|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
69066|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
69067|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
69068|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
69069|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
69070|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
69071|NCT01959880|E4|Reported Event|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
69191|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69072|NCT01959880|E3|Reported Event|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
69073|NCT01959880|E2|Reported Event|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
69074|NCT01959880|E1|Reported Event|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
69075|NCT01959685|B1|Baseline|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
69076|NCT01959685|P1|Participant Flow|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
69077|NCT01959685|O1|Outcome|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
69078|NCT01959685|O1|Outcome|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
69079|NCT01959685|E1|Reported Event|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
69080|NCT01959607|B3|Baseline|Total|Total of all reporting groups
69083|NCT01959607|P4|Participant Flow|NRT Then THS 2.2|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single administration of NRT gum [Nicorette ® 2mg])
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of THS 2.2)."
69084|NCT01959607|P3|Participant Flow|THS 2.2 Then NRT|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of THS 2.2)
Day 2 = wash-out
Day 3 = 2nd intervention (single administration of NRT gum [Nicorette ® 2mg])."
69085|NCT01959607|P2|Participant Flow|CC Then THS 2.2|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of CC)
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of THS 2.2)."
69086|NCT01959607|P1|Participant Flow|THS 2.2 Then CC|"Each subject will follow the below study design:
Day 0 = Wash-out (1 day)
Day 1 = 1st intervention (single product use of THS 2.2)
Day 2 = wash-out
Day 3 = 2nd intervention (single product use of CC)."
69087|NCT01959607|O1|Outcome|Ratio THS 2.2:CC|"This population comprises the following sequences:
Sequence THS 2.2 then CC
Sequence CC then THS 2.2."
69088|NCT01959607|O1|Outcome|Ratio THS 2.2:CC|"This population comprises the following sequences:
Sequence THS 2.2 then CC
Sequence CC then THS 2.2"
69089|NCT01959607|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
69090|NCT01959607|E2|Reported Event|Group 2|"This population comprises the following sequences:
Sequence THS 2.2 then NRT
Sequence NRT then THS 2.2"
69091|NCT01959607|E1|Reported Event|Group 1|"This population comprises the following sequences:
Sequence THS 2.2 then CC
Sequence CC then THS 2.2"
69092|NCT01959581|B1|Baseline|Movement Enhancing Device|"Guided play while wearing a movement assisting device
Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
69093|NCT01959581|P1|Participant Flow|Movement Enhancing Device|"Guided play while wearing a movement assisting device
Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
69094|NCT01959581|O1|Outcome|Movement Enhancing Device|"Guided play while wearing a movement assisting device
Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
69095|NCT01959581|E1|Reported Event|Movement Enhancing Device|"Guided play while wearing a movement assisting device
Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device."
69096|NCT01959516|B1|Baseline|All Participants (Intent To Treat Analysis,ITT)|All participants who were randomized to one of the two treatment sequences in a ratio of 1:1. Participants will receive sequence A = glycopyrronium + placebo to tiotropium during 28 days, followed by a 14 day washout period, then sequence B= tiotropium + placebo to glycopyrronium for 28 days.
69097|NCT01959516|P2|Participant Flow|Tiotropium First, Then Glycopyrronium|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
69098|NCT01959516|P1|Participant Flow|"Glycopyrronium First, Then Tiotropium"|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
69099|NCT01959516|O2|Outcome|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
69100|NCT01959516|O1|Outcome|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
69101|NCT01959516|O2|Outcome|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
69102|NCT01959516|O1|Outcome|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
69192|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69103|NCT01959516|E2|Reported Event|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
69104|NCT01959516|E1|Reported Event|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
69105|NCT01959503|B3|Baseline|Total|Total of all reporting groups
69106|NCT01959503|B2|Baseline|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus"
69107|NCT01959503|B1|Baseline|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant"
69108|NCT01959503|P2|Participant Flow|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus"
69109|NCT01959503|P1|Participant Flow|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant"
69110|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus"
69111|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant"
69112|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus"
69114|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus"
69115|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant"
69116|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus"
69117|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant"
69118|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus"
69119|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant"
69120|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus"
69121|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant"
69122|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus"
69123|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant"
69124|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus"
69125|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant"
69126|NCT01959503|E2|Reported Event|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus"
69127|NCT01959503|E1|Reported Event|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant"
69128|NCT01959412|B1|Baseline|All Participants|All participants randomized to one of six treatment sequences
69129|NCT01959412|P6|Participant Flow|Sequence 6 (Placebo)|Placebo, indacaterol 37.5 μg, indacaterol 27.5 μg indacaterol 55 μg, indacaterol 150 μg, indacaterol 75 μg Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
69130|NCT01959412|P5|Participant Flow|Sequence 5 (Ind 27.5 μg)|indacaterol 27.5 μg placebo indacaterol 150 μg indacaterol 37.5 μg indacaterol 75 μg indacaterol 55 μg Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
69131|NCT01959412|P4|Participant Flow|Sequence 1 (Ind 37.5 μg)|indacaterol 37.5 μg indacaterol 55μg Placebo indacaterol 75μg indacaterol 27.5μg indacaterol 150μg indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
69132|NCT01959412|P3|Participant Flow|Sequence 2 (Ind 55 μg)|indacaterol 55 μg indacaterol 75 μg indacaterol 37.5 μg indacaterol 150 μg placebo indacaterol 27.5 μg Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
69193|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
72662|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
69133|NCT01959412|P2|Participant Flow|Sequence 3 (Ind 75 μg)|indacaterol 75 μg indacaterol 150 μg indacaterol 55 μg indacaterol 27.5 μg indacaterol 37.5 μg placebo Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
69134|NCT01959412|P1|Participant Flow|Sequence 4 (Ind 150 μg)|indacaterol 150 μg, indacaterol 27.5 μg, indacaterol 75 μg, placebo indacaterol 55 μg indacaterol 37.5 μg Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
69135|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
69136|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
69137|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
69138|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
69139|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
69140|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
69141|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
69142|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
69143|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
69144|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
69145|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
69146|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
69147|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
69148|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
69149|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
69150|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
69151|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
69205|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69152|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
69153|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
69154|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
69155|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
69156|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
69157|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
69158|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
69159|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
69160|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
69161|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
69162|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
69194|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69163|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
69164|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
69165|NCT01959412|E6|Reported Event|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
69166|NCT01959412|E5|Reported Event|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
69167|NCT01959412|E4|Reported Event|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
69168|NCT01959412|E3|Reported Event|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
69169|NCT01959412|E2|Reported Event|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
69170|NCT01959412|E1|Reported Event|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
69171|NCT01959035|B1|Baseline|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69172|NCT01959035|P1|Participant Flow|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month depending on the last dose that they had received in Study 14724A; 6 intramuscular (IM) injections starting at baseline
69173|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69174|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69175|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69176|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69177|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69178|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69179|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69180|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69181|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69182|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69183|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69184|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69185|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69186|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69187|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69188|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69189|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69190|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69195|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69196|NCT01959035|E1|Reported Event|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
69197|NCT01958827|B1|Baseline|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69198|NCT01958827|P1|Participant Flow|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69199|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69200|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69201|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69202|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69203|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69204|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69481|NCT01957579|O4|Outcome|12 mg/kg (MM)|MM patients in MEDI-551 12 mg/kg cohort
69206|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69207|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69208|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69209|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69210|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69211|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69212|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69213|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69214|NCT01958827|E1|Reported Event|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
69215|NCT01958788|B1|Baseline|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments
69216|NCT01958788|P1|Participant Flow|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
69217|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
69218|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
69219|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
69220|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
69221|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
69222|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
69223|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
69224|NCT01958788|E1|Reported Event|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments
69225|NCT01958645|B4|Baseline|Total|Total of all reporting groups
69226|NCT01958645|B3|Baseline|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
69227|NCT01958645|B2|Baseline|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
69228|NCT01958645|B1|Baseline|Placebo|Placebo (Saline solution for infusion)
69229|NCT01958645|P3|Participant Flow|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
69230|NCT01958645|P2|Participant Flow|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
69231|NCT01958645|P1|Participant Flow|Placebo|Placebo (Saline solution for infusion)
69232|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
69233|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
69234|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
69235|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
69236|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
69237|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
72663|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
69238|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
69239|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
69240|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
69241|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
69242|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
69243|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
69244|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
69245|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
69246|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
69247|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
69248|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
69249|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
69250|NCT01958645|O1|Outcome|Placebo|Placebo (Saline solution for infusion)
69251|NCT01958645|E3|Reported Event|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
69252|NCT01958645|E2|Reported Event|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
69253|NCT01958645|E1|Reported Event|Placebo|Placebo (Saline solution for infusion)
69254|NCT01958619|B5|Baseline|Total|Total of all reporting groups
69256|NCT01958619|B3|Baseline|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69257|NCT01958619|B2|Baseline|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69258|NCT01958619|B1|Baseline|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69259|NCT01958619|P4|Participant Flow|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69260|NCT01958619|P3|Participant Flow|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69261|NCT01958619|P2|Participant Flow|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69262|NCT01958619|P1|Participant Flow|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69263|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69264|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69265|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69266|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69267|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69268|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69269|NCT01958619|O4|Outcome|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69270|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69271|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69272|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69273|NCT01958619|O4|Outcome|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69274|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69275|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69276|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69277|NCT01958619|E4|Reported Event|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69278|NCT01958619|E3|Reported Event|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69279|NCT01958619|E2|Reported Event|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69280|NCT01958619|E1|Reported Event|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
69281|NCT01958606|B3|Baseline|Total|Total of all reporting groups
69282|NCT01958606|B2|Baseline|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69283|NCT01958606|B1|Baseline|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69284|NCT01958606|P2|Participant Flow|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69285|NCT01958606|P1|Participant Flow|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69286|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69287|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69288|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69289|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
94719|NCT01813721|O4|Outcome|Small Cell Lung Cancer|
69290|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69291|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69292|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69293|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69294|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69295|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69296|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69297|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69298|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69299|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69300|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69301|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69302|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69303|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69304|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69305|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69306|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69307|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69308|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69309|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69310|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69311|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69312|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69313|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69314|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69315|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69316|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69317|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69318|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69319|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69320|NCT01958606|E2|Reported Event|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill
Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
69321|NCT01958606|E1|Reported Event|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods
High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
69322|NCT01958346|B3|Baseline|Total|Total of all reporting groups
69323|NCT01958346|B2|Baseline|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.
Fiberoptic Intubation"
69324|NCT01958346|B1|Baseline|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers
Fiberoptic Intubation"
69325|NCT01958346|P2|Participant Flow|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.
Fiberoptic Intubation"
69326|NCT01958346|P1|Participant Flow|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers
Fiberoptic Intubation"
69327|NCT01958346|O2|Outcome|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.
Fiberoptic Intubation"
69328|NCT01958346|O1|Outcome|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers
Fiberoptic Intubation"
69329|NCT01958346|O2|Outcome|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.
Fiberoptic Intubation"
69330|NCT01958346|O1|Outcome|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers
Fiberoptic Intubation"
69331|NCT01958346|E2|Reported Event|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.
Fiberoptic Intubation"
69332|NCT01958346|E1|Reported Event|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers
Fiberoptic Intubation"
69333|NCT01958164|B3|Baseline|Total|Total of all reporting groups
69334|NCT01958164|B2|Baseline|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
69335|NCT01958164|B1|Baseline|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
69336|NCT01958164|P2|Participant Flow|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
69337|NCT01958164|P1|Participant Flow|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
69338|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
69339|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
69340|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
69376|NCT01958060|O1|Outcome|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
69341|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
69342|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
69343|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
69344|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
69345|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
69346|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
69347|NCT01958164|E2|Reported Event|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
69348|NCT01958164|E1|Reported Event|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
69349|NCT01958060|B7|Baseline|Total|Total of all reporting groups
69350|NCT01958060|B6|Baseline|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69351|NCT01958060|B5|Baseline|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69352|NCT01958060|B4|Baseline|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69353|NCT01958060|B3|Baseline|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69354|NCT01958060|B2|Baseline|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69355|NCT01958060|B1|Baseline|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
69356|NCT01958060|P6|Participant Flow|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69357|NCT01958060|P5|Participant Flow|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69358|NCT01958060|P4|Participant Flow|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69359|NCT01958060|P3|Participant Flow|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69360|NCT01958060|P2|Participant Flow|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69361|NCT01958060|P1|Participant Flow|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
69362|NCT01958060|O4|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69363|NCT01958060|O3|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69364|NCT01958060|O2|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69365|NCT01958060|O1|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69366|NCT01958060|O1|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69367|NCT01958060|O4|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69368|NCT01958060|O3|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69369|NCT01958060|O2|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69370|NCT01958060|O1|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69371|NCT01958060|O6|Outcome|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69372|NCT01958060|O5|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69373|NCT01958060|O4|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69374|NCT01958060|O3|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69375|NCT01958060|O2|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69377|NCT01958060|E6|Reported Event|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69378|NCT01958060|E5|Reported Event|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69379|NCT01958060|E4|Reported Event|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69380|NCT01958060|E3|Reported Event|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69381|NCT01958060|E2|Reported Event|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
69382|NCT01958060|E1|Reported Event|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
69383|NCT01958021|B3|Baseline|Total|Total of all reporting groups
69384|NCT01958021|B2|Baseline|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
69385|NCT01958021|B1|Baseline|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
69386|NCT01958021|P2|Participant Flow|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
69482|NCT01957579|O3|Outcome|8 mg/kg (MM)|MM patients in MEDI-551 8 mg/kg cohort
69387|NCT01958021|P1|Participant Flow|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
69388|NCT01958021|O2|Outcome|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
69389|NCT01958021|O1|Outcome|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
69390|NCT01958021|O2|Outcome|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
69391|NCT01958021|O1|Outcome|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
69392|NCT01958021|E2|Reported Event|Placebo + Letrozole 2.5mg|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
69393|NCT01958021|E1|Reported Event|Ribociclib 600mg + Letrozole 2.5mg|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
69394|NCT01958008|B5|Baseline|Total|Total of all reporting groups
69395|NCT01958008|B4|Baseline|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
69396|NCT01958008|B3|Baseline|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
69397|NCT01958008|B2|Baseline|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
69398|NCT01958008|B1|Baseline|Placebo|Oral administration of Placebo matching BI 113608
69399|NCT01958008|P4|Participant Flow|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
69400|NCT01958008|P3|Participant Flow|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
69401|NCT01958008|P2|Participant Flow|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
69402|NCT01958008|P1|Participant Flow|Placebo|Oral administration of Placebo matching BI 113608
69403|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
69404|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
69405|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
69406|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
69407|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
69408|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
69409|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
69410|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
69411|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
69412|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
69413|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
69414|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
69415|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
69416|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
69417|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
69418|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
69419|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
69420|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
69421|NCT01958008|O4|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
69422|NCT01958008|O3|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
72667|NCT01941498|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
69423|NCT01958008|O2|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
69424|NCT01958008|O1|Outcome|Placebo|Oral administration of Placebo matching BI 113608
69425|NCT01958008|E4|Reported Event|50 mg Bid|Oral administration of BI 113608 50 mg film coated tablets twice daily
69426|NCT01958008|E3|Reported Event|25 mg Bid|Oral administration of BI 113608 25 mg film coated tablets twice daily
69427|NCT01958008|E2|Reported Event|10 mg Bid|Oral administration of BI 113608 10 mg film coated tablets twice daily
69428|NCT01958008|E1|Reported Event|Placebo|Oral administration of Placebo matching BI 113608
69429|NCT01957930|B3|Baseline|Total|Total of all reporting groups
69430|NCT01957930|B2|Baseline|Standard-treatment|"Continuing with routine diabetes care
Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
69431|NCT01957930|B1|Baseline|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
69432|NCT01957930|P2|Participant Flow|Standard-treatment|"Continuing with routine diabetes care
Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
69433|NCT01957930|P1|Participant Flow|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
94720|NCT01813721|O3|Outcome|Non-Hodgkin's Lymphoma|
69434|NCT01957930|O2|Outcome|Standard-treatment|"Continuing with routine diabetes care
Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
69435|NCT01957930|O1|Outcome|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
69436|NCT01957930|E2|Reported Event|Standard-treatment|"Continuing with routine diabetes care
Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
69437|NCT01957930|E1|Reported Event|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
69438|NCT01957865|B4|Baseline|Total|Total of all reporting groups
69439|NCT01957865|B3|Baseline|Control|Real-time adherence monitoring only (no SMS)
69440|NCT01957865|B2|Baseline|Triggered SMS, Real-time Monitoring|SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
69441|NCT01957865|B1|Baseline|Fixed SMS, Real-time Monitoring|SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
69442|NCT01957865|P3|Participant Flow|Control|Real-time adherence monitoring only (no SMS)
69443|NCT01957865|P2|Participant Flow|Triggered SMS, Real-time Monitoring|SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
69444|NCT01957865|P1|Participant Flow|Fixed SMS, Real-time Monitoring|SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
69445|NCT01957865|O3|Outcome|Control|Real-time adherence monitoring only (no SMS)
69446|NCT01957865|O2|Outcome|Triggered SMS, Real-time Monitoring|"Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence"
69447|NCT01957865|O1|Outcome|Fixed SMS, Real-time Monitoring|"Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
69448|NCT01957865|O3|Outcome|Control|Real-time adherence monitoring only (no SMS)
69449|NCT01957865|O2|Outcome|Triggered SMS, Real-time Monitoring|"Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
69450|NCT01957865|O1|Outcome|Fixed SMS, Real-time Monitoring|"Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
69451|NCT01957865|E3|Reported Event|Control|Real-time adherence monitoring only (no SMS)
69452|NCT01957865|E2|Reported Event|Triggered SMS, Real-time Monitoring|"Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence."
69710|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
69711|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
69453|NCT01957865|E1|Reported Event|Fixed SMS, Real-time Monitoring|"SMS were sent daily for one month, then weekly for two months. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence."
69454|NCT01957761|B1|Baseline|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
69455|NCT01957761|P1|Participant Flow|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
69456|NCT01957761|O1|Outcome|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
69457|NCT01957761|E1|Reported Event|Clostridium Difficile Infection|
69458|NCT01957657|B1|Baseline|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69483|NCT01957579|O2|Outcome|4 mg/kg (MM)|MM patients in MEDI-551 4 mg/kg cohort
69484|NCT01957579|O1|Outcome|2 mg/kg (MM)|MM patients in MEDI-551 2 mg/kg cohort
69485|NCT01957579|O4|Outcome|12 mg/kg (CLL)|CLL patients in MEDI-551 12 mg/kg cohort
69459|NCT01957657|P1|Participant Flow|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir, immediate release tablet, plus faldaprevir, soft gelatin capsule, were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir, qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69460|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69461|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69462|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69463|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69464|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69465|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69466|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69467|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69468|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69469|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69712|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
69470|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69471|NCT01957657|E1|Reported Event|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.
Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.
All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
69472|NCT01957579|B5|Baseline|Total|Total of all reporting groups
69473|NCT01957579|B4|Baseline|12 mg/kg|MEDI-551 12 mg/kg
69474|NCT01957579|B3|Baseline|8 mg/kg|MEDI-551 8 mg/kg
69475|NCT01957579|B2|Baseline|4 mg/kg|MEDI-551 4 mg/kg
69476|NCT01957579|B1|Baseline|2 mg/kg|MEDI-551 2mg/kg
69477|NCT01957579|P4|Participant Flow|12 mg/kg|MEDI-551 12 mg/kg
69478|NCT01957579|P3|Participant Flow|8 mg/kg|MEDI-551 8 mg/kg
69479|NCT01957579|P2|Participant Flow|4 mg/kg|MEDI-551 4 mg/kg
69495|NCT01957579|O2|Outcome|4 mg/kg (FL)|FL patients in MEDI-551 4 mg/kg cohort
69496|NCT01957579|O1|Outcome|2 mg/kg (FL)|FL patients in MEDI-551 2 mg/kg cohort
69497|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
69498|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
69499|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
69500|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
69501|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
69502|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
69503|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
69504|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
69505|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
69506|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
69507|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
69508|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
69509|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
69510|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
69511|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
69512|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
69513|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
69514|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
69515|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
69516|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
69517|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
69518|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
69519|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
69520|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
69521|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
69522|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
69523|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
69524|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
69525|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
69526|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
69527|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
69528|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
69529|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
69530|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
69531|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
69532|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
69533|NCT01957579|O1|Outcome|MEDI-551|MEDI-551 2, 4, 8 and 12 mg/kg were evaluated
69534|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
69535|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
69536|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
69537|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
69538|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
69539|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
69540|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
69541|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
69542|NCT01957579|E4|Reported Event|12 mg/kg|MEDI-551 12 mg/kg
69543|NCT01957579|E3|Reported Event|8 mg/kg|MEDI-551 8 mg/kg
69544|NCT01957579|E2|Reported Event|4 mg/kg|MEDI-551 4 mg/kg
69545|NCT01957579|E1|Reported Event|2 mg/kg|MEDI-551 2mg/kg
69546|NCT01957553|B1|Baseline|All Subjects|baseline data are summarized for all subjects
72668|NCT01941498|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
69547|NCT01957553|P2|Participant Flow|Treatment Seqence 2; First SenSura the Coloplast Test Product|"Subjects first allocated to SenSura will after cross-over test Coloplast Test product
Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance
SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S"
69548|NCT01957553|P1|Participant Flow|Treatment Sequence 1, First Coloplast Test Product, the SenSur|"Subjects first allocated to Coloplast Test product will after cross-over test SenSura
Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance
SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S"
69549|NCT01957553|O2|Outcome|SenSura|
69550|NCT01957553|O1|Outcome|Coloplast Test Product|
69551|NCT01957553|E2|Reported Event|SenSura|Safety data for subjects exposed to SenSura
69552|NCT01957553|E1|Reported Event|Test Product|Safety data for subjects exposed to the test product
69553|NCT01957488|B1|Baseline|All Subjects|
69554|NCT01957488|P6|Participant Flow|Test 2/Test 1/SenSura|"The subjects in this group test the following in the order described below:
Test 2
Test 1
SenSura (the comparator)
The products are single use products which in average are removed and re-applyed every1-2nd day."
69555|NCT01957488|P5|Participant Flow|Test 2/SenSura/Test 1|"The subjects in this group test the following in the order described below:
Test 2
SenSura (the comparator)
Test 1
The products are single use products which in average are removed and re-applyed every1-2nd day."
69556|NCT01957488|P4|Participant Flow|Test 1/Test 2/SenSura|"The subjects in this group test the following in the order described below:
Test 1
Test 2
SenSura (the comparator)
The products are single use products which in average are removed and re-applyed every1-2nd day."
69557|NCT01957488|P3|Participant Flow|Test 1/SenSura/Test 2|"The subjects in this group test the following in the order described below:
Test 1
SenSura (the comparator)
Test 2
The products are single use products which in average are removed and re-applyed every1-2nd day."
69558|NCT01957488|P2|Participant Flow|SenSura/Test 2/Test 1|"The subjects in this group test the following in the order described below:
SenSura (the comparator)
Test 2
Test 1
The products are single use products which in average are removed and re-applyed every1-2nd day."
69559|NCT01957488|P1|Participant Flow|SenSura/Test 1/Test 2|"The subjects in this group test the following in the order described below:
SenSura (the comparator)
Test 1
Test 2
The products are single use products which in average are removed and re-applyed every1-2nd day."
69560|NCT01957488|O3|Outcome|SenSura|Fraction of baseplates with No leakage/Seeping under the baseplate for subjects testing SenSura
69561|NCT01957488|O2|Outcome|Test 2|Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 2
69562|NCT01957488|O1|Outcome|Test 1|Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 1
69563|NCT01957488|E3|Reported Event|SenSura|Subjects testing SenSura
69564|NCT01957488|E2|Reported Event|Test 2|Subjects testing Coloplast Test 2
69565|NCT01957488|E1|Reported Event|Test 1|Subjects testing Coloplast Test 1
69566|NCT01957475|B1|Baseline|All Subjects|
69567|NCT01957475|P2|Participant Flow|First Coloplast Test Product Y, Then Coloplast Test Product Z|"The subjects first test test product Y and after cross-over test product Z
Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance
Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance"
69568|NCT01957475|P1|Participant Flow|First Coloplast Test Product Z; Then Coloplast Test Product Y|"The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y
Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance
Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance"
69569|NCT01957475|O2|Outcome|Test Z|Results from the subjects testing Coloplast Test Y
69570|NCT01957475|O1|Outcome|Test Y|Results from the subjects testing Coloplast Test Y
69571|NCT01957475|E2|Reported Event|Test Z|Results from the subjects testing Coloplast Test Y
69572|NCT01957475|E1|Reported Event|Test Y|Results from the subjects testing Coloplast Test Y
69573|NCT01957462|B1|Baseline|All Subjects|
69574|NCT01957462|P2|Participant Flow|First Coloplast Test X, Then Coloplast Test V|"The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V
Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance
Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance"
69575|NCT01957462|P1|Participant Flow|FirstColplast Test V, Then Coloplast Test X|"The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X
Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance
Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance"
69576|NCT01957462|O2|Outcome|Test X|the results presented for the subjects testing Test X
69577|NCT01957462|O1|Outcome|Test V|The results presented for the subjects testing Coloplast Test V
69578|NCT01957462|E2|Reported Event|Test X|the results presented for the subjects testing Test X
69579|NCT01957462|E1|Reported Event|Test V|The results presented for the subjects testing Coloplast Test V
69580|NCT01957410|B1|Baseline|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
69581|NCT01957410|P1|Participant Flow|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
69713|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
69582|NCT01957410|O1|Outcome|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
69583|NCT01957410|O1|Outcome|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
69584|NCT01957410|E1|Reported Event|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
69585|NCT01957397|B1|Baseline|Overall Population|
69586|NCT01957397|P2|Participant Flow|1st Coloplast Test 2 2nd Coloplast Test 1 3rd Coloplast Test 3|"The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1
Finally the all subject test Coloplast Test 3
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
69587|NCT01957397|P1|Participant Flow|1st Coloplast Test 1,2nd Coloplast Test 2 3rd Coloplast Test 3|"The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2
Finally the all subject test Coloplast Test 3
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
69588|NCT01957397|O4|Outcome|Baseline - Own Product|The subjects test own product to measure their baseline leakage
69589|NCT01957397|O3|Outcome|Coloplast Test 3|Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
69625|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
69626|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
69590|NCT01957397|O2|Outcome|Coloplast Test 2|"The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1
Finally the all subject test Coloplast Test 3
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
69591|NCT01957397|O1|Outcome|Coloplast Test 1|"The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2
Finally the all subject test Coloplast Test 3
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
69592|NCT01957397|E4|Reported Event|Baseline - Own Product|The subjects test own product to measure their baseline leakage
69593|NCT01957397|E3|Reported Event|Coloplast Test 3|Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
69594|NCT01957397|E2|Reported Event|Coloplast Test 2|Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
69595|NCT01957397|E1|Reported Event|Coloplast Test 1|Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
69596|NCT01957384|B1|Baseline|All Subjects|
69597|NCT01957384|P6|Participant Flow|First Standard Care, Then Test Product 2, Then Test Product 1|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test
1) Coloplast Test product 2
and thereafter
1) Coloplast Test product 1"
69598|NCT01957384|P5|Participant Flow|First Standard Care, Then Test Product 1, Then Test Product 2|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test
1) Coloplast Test product 1
and thereafter
1) Coloplast Test product 2"
69599|NCT01957384|P4|Participant Flow|First Test Product 2; Then Standard Care, Then Test Product 1|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 2 are randomised to secondly test :
1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
and thereafter
1) Coloplast Test product 1"
69600|NCT01957384|P3|Participant Flow|First Test Product 2, Then Test Product 1, Then Standard Care|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 2 are randomised to secondly test
1) Coloplast Test product 1
and thereafter
1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)"
69601|NCT01957384|P2|Participant Flow|First Test Product 1, Then Standard Care, Then Test Product 2|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 1 are randomised to secondly test :
1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
and thereafter
1) Coloplast Test product 2"
69714|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
69715|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
69602|NCT01957384|P1|Participant Flow|First Test Product 1, Then Test Product 2;Then Standard Care|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 1 are randomised to secondly test :
- Coloplast Test product 2
and thereafter
- Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2"
69603|NCT01957384|O3|Outcome|Standard Care|leakage data from all Standard Care baseplates
69604|NCT01957384|O2|Outcome|Coloplast Test Product 2|Leakage data from all Test 2 baseplates
69605|NCT01957384|O1|Outcome|Coloplast Test Product 1|leakage data from all Test 1 baseplates
69606|NCT01957384|E3|Reported Event|Standard Care|data from all subjects who tested Standard Care baseplates
69607|NCT01957384|E2|Reported Event|Coloplast Test Product 2|data from all subjects who tested Test 2 baseplates
69608|NCT01957384|E1|Reported Event|Coloplast Test Product 1|data from all subjects who tested Test 1 baseplates
69609|NCT01957215|B3|Baseline|Total|Total of all reporting groups
69610|NCT01957215|B2|Baseline|Placebo Patch|Placebo patch was applied on the sprained ankle BID
69611|NCT01957215|B1|Baseline|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
69612|NCT01957215|P2|Participant Flow|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
69613|NCT01957215|P1|Participant Flow|Indomethacin Patch|0.35% w/w Indomethacin patch was applied on the sprained ankle twice a day (BID).
69614|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
69615|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
69616|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
69617|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
69618|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
69619|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
69620|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
69621|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
69622|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
69623|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
69624|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
69627|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
69628|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
69629|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
69630|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
69631|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID.
69632|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
69633|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
69634|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
69635|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
69636|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
69637|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
69638|NCT01957215|E2|Reported Event|Placebo Patch|Placebo patch to be applied on the sprained ankle BID.
69639|NCT01957215|E1|Reported Event|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle twice a day (BID).
69640|NCT01957202|B1|Baseline|FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg, Placebo|Participants received FF 100 µg, Levo 200 µg, FF 100 μg/Levo 200 μg and placebo once daily (OD) in the morning as 2 nasal sprays (FF: 25 µg per spray, Levo: 50 μg per spray, FF/Levo: 25 μg/50 μg per spray) into each nostril for 8 days each, in a crossover design. Treatment was given in one of 18 sequences in Periods 1, 2, and 3, (with a minimum of a 14-day washout period between treatments): BCD, BAC, BCA, DAC, DCB, CDB, ADC, CAD, DCA, ACB, BDC, CBA, CBD, ACD, CAB, CDA, ABC, DBC (A, FF 100 μg; B, Levo 200 μg; C, FF 100 μg/Levo 200 μg; D, placebo). On Day 1 and Day 8 of each treatment period, participants were subjected to an allergen challenge in a Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit of 14-28 days after their last dose, and the overall duration for participation in the study (screening to follow-up) was 20 weeks.
69641|NCT01957202|P18|Participant Flow|Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg|Participants received placebo, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69642|NCT01957202|P17|Participant Flow|Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg|Participants received FF 100 µg, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69716|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
69717|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
69718|NCT01957137|E5|Reported Event|No Stimulation|Subjects received no stimulation for approximately 4 weeks.
69643|NCT01957202|P16|Participant Flow|Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg|Participants received FF 100 μg/Levo 200 μg, placeboμg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo µg OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69644|NCT01957202|P15|Participant Flow|Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg|Participants received FF 100 μg/Levo 200 μg, FF 100 µg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69645|NCT01957202|P14|Participant Flow|Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo|Participants received FF 100 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69646|NCT01957202|P13|Participant Flow|Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo|Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69647|NCT01957202|P12|Participant Flow|Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg|Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69648|NCT01957202|P11|Participant Flow|Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg|Participants received Levo 200 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
94721|NCT01813721|O2|Outcome|Non-small Cell Lung Cancer|
69649|NCT01957202|P10|Participant Flow|Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg|Participants received FF 100 µg, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69650|NCT01957202|P9|Participant Flow|Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg|Participants received placebo, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69651|NCT01957202|P8|Participant Flow|Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo|Participants received FF 100 μg/Levo 200 μg, FF 100 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69652|NCT01957202|P7|Participant Flow|Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg|Participants received FF 100 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69653|NCT01957202|P6|Participant Flow|Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg|Participants received FF 100 μg/Levo 200 μg, placebo and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69654|NCT01957202|P5|Participant Flow|Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg|Participants received placebo, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69655|NCT01957202|P4|Participant Flow|Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg|Participants received placebo, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69719|NCT01957137|E4|Reported Event|Cycling Parameter #3|Subjects received Cycling Parameter #3 for approximately 4 weeks.
69720|NCT01957137|E3|Reported Event|Cycling Parameter #2|Subjects received Cycling Parameter #2 for approximately 4 weeks.
69656|NCT01957202|P3|Participant Flow|Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg|Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69657|NCT01957202|P2|Participant Flow|Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg|Participants received Levo 200 µg, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69658|NCT01957202|P1|Participant Flow|Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, Placebo|Participants received levocabastine (Levo) 200 micrograms (µg), fluticasone furoate (FF) 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg once daily (OD) in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
69659|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
69660|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
69661|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
69662|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
69663|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
69664|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
69665|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
69666|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
69667|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
69668|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
69669|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
69670|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
69671|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
69672|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
69673|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
69674|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
69675|NCT01957202|E4|Reported Event|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
69676|NCT01957202|E3|Reported Event|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
69677|NCT01957202|E2|Reported Event|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
69678|NCT01957202|E1|Reported Event|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
69679|NCT01957163|B4|Baseline|Total|Total of all reporting groups
69680|NCT01957163|B3|Baseline|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69681|NCT01957163|B2|Baseline|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69682|NCT01957163|B1|Baseline|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69683|NCT01957163|P3|Participant Flow|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69721|NCT01957137|E2|Reported Event|Cycling Parameter #1|Subjects received Cycling Parameter #1 for approximately 4 weeks.
69722|NCT01957137|E1|Reported Event|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
69723|NCT01957111|B3|Baseline|Total|Total of all reporting groups
69684|NCT01957163|P2|Participant Flow|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69685|NCT01957163|P1|Participant Flow|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69686|NCT01957163|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69687|NCT01957163|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69688|NCT01957163|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69689|NCT01957163|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69690|NCT01957163|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69839|NCT01955720|O13|Outcome|150 mg/Plc. 5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g
69840|NCT01955720|O12|Outcome|150 mg/5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
69691|NCT01957163|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69692|NCT01957163|E3|Reported Event|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69693|NCT01957163|E2|Reported Event|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69694|NCT01957163|E1|Reported Event|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
69695|NCT01957137|B1|Baseline|Subjects Who First Finished Unique Randomization Sequences|Baseline descriptions provided were based on 24 subjects who first finished unique randomization sequences, which are those subjects included in the primary analysis of the primary outcome.
69696|NCT01957137|P1|Participant Flow|All Study Participants|Thirty subjects were randomized to 1 of 24 sequences with 4 cycling settings: 2 subjects discontinued early with 1 due to an AE, and 1 due to consent withdrawal. Twenty-eight subjects completed the randomization sequences . After that all subjects went through no stimulation for approximately 4 weeks, which was not part of randomization.
69697|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
69698|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
69699|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
69700|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
69701|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
69702|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
69703|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
69704|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
69705|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
69706|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
69707|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
69708|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
69709|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
69724|NCT01957111|B2|Baseline|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
69725|NCT01957111|B1|Baseline|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
69726|NCT01957111|P2|Participant Flow|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
69727|NCT01957111|P1|Participant Flow|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
69728|NCT01957111|O2|Outcome|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
69742|NCT01956240|O1|Outcome|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
69902|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
69729|NCT01957111|O1|Outcome|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
69730|NCT01957111|O2|Outcome|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
69731|NCT01957111|O1|Outcome|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
69732|NCT01957111|E2|Reported Event|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
69733|NCT01957111|E1|Reported Event|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
69734|NCT01956240|B3|Baseline|Total|Total of all reporting groups
69735|NCT01956240|B2|Baseline|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
69736|NCT01956240|B1|Baseline|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
69737|NCT01956240|P2|Participant Flow|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
69772|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
72669|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
69738|NCT01956240|P1|Participant Flow|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
69739|NCT01956240|O2|Outcome|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
69740|NCT01956240|O1|Outcome|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
69741|NCT01956240|O2|Outcome|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
69780|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69841|NCT01955720|O11|Outcome|150 mg/Plc. 1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g
69743|NCT01956240|E2|Reported Event|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
69744|NCT01956240|E1|Reported Event|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
69745|NCT01956097|B4|Baseline|Total|Total of all reporting groups
69746|NCT01956097|B3|Baseline|Placebo|"Placebo
Placebo"
69747|NCT01956097|B2|Baseline|HX106 1180mg|"HX106 1180mg/day
HX106 1180mg"
69748|NCT01956097|B1|Baseline|HX106 590mg|"HX106 590mg/day
HX106 590mg"
69749|NCT01956097|P3|Participant Flow|Placebo|"Placebo
Placebo"
69750|NCT01956097|P2|Participant Flow|HX106 1180mg|"HX106 1180mg/day
HX106 1180mg"
69751|NCT01956097|P1|Participant Flow|HX106 590mg|"HX106 590mg/day
HX106 590mg"
69752|NCT01956097|O3|Outcome|Placebo|"Placebo
Placebo"
69753|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day
HX106 1180mg"
69754|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day
HX106 590mg"
69755|NCT01956097|O3|Outcome|Placebo|"Placebo
Placebo"
69756|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day
HX106 1180mg"
69757|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day
HX106 590mg"
69758|NCT01956097|O3|Outcome|Placebo|"Placebo
Placebo"
69759|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day
HX106 1180mg"
69760|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day
HX106 590mg"
69761|NCT01956097|O3|Outcome|Placebo|"Placebo
Placebo"
69762|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day
HX106 1180mg"
69763|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day
HX106 590mg"
69764|NCT01956097|E3|Reported Event|Placebo|"Placebo
Placebo"
69765|NCT01956097|E2|Reported Event|HX106 1180mg|"HX106 1180mg/day
HX106 1180mg"
69766|NCT01956097|E1|Reported Event|HX106 590mg|"HX106 590mg/day
HX106 590mg"
69767|NCT01956032|B1|Baseline|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69768|NCT01956032|P1|Participant Flow|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69769|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69770|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69771|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69819|NCT01955720|P2|Participant Flow|Placebo / 5 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 5g followed by dabigatran 220 mg plus Ida 5g (high dose)
72670|NCT01941498|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
69773|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69774|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69775|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69776|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69777|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69778|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69779|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69838|NCT01955720|O14|Outcome|150 mg /2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart.
69899|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
69781|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69782|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69783|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69784|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69785|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69786|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69787|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69788|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69789|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69790|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69791|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69792|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69793|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69794|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69820|NCT01955720|P1|Participant Flow|5 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus idarucizumab (Ida) 5g followed by dabigatran 220 mg plus placebo 5g (high dose)
69795|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69796|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69797|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69798|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69799|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69800|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69801|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69802|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69903|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
69803|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69804|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69805|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69806|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69807|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69808|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69809|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69810|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69811|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69812|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69813|NCT01956032|E1|Reported Event|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
69814|NCT01955720|B1|Baseline|Total Subjects Group|The total subjects group contains the following sub-groups: high dose (5 g idarucizumab), healthy, aged 45-64 yrs: high dose (5 g idarucizumab), healthy elderly, aged 65-80 yrs: high dose (5 g idarucizumab), mild renal impairment (RI), aged 45-80 yrs: high dose (2.5 g + 2.5 g idarucizumab), with moderate RI, aged 45-80 yrs: medium dose (2.5 g idarucizumab), healthy, aged 45-64 yrs: low dose (1 g idarucizumab), healthy elderly, aged 65-80 yrs: low dose (1 g idarucizumab), with mild RI, aged 45-80 yrs.
69815|NCT01955720|P6|Participant Flow|Placebo / 1 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 1g followed by dabigatran 220 mg plus Ida 1g (low dose)
69816|NCT01955720|P5|Participant Flow|1 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus Ida 1g followed by dabigatran 220 mg plus placebo 1g (low dose)
69817|NCT01955720|P4|Participant Flow|Placebo / 2.5 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 2.5g followed by dabigatran 220 mg plus Ida 2.5g (medium dose)
69818|NCT01955720|P3|Participant Flow|2.5 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus Ida 2.5g followed by dabigatran 220 mg plus placebo 2.5g (medium dose)
69821|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
69822|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
69823|NCT01955720|O6|Outcome|150 mg/1 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
69824|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
69825|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
69826|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
69827|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
69828|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
69829|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
69830|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
69831|NCT01955720|O6|Outcome|150 mg/1 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
69832|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
69833|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
69834|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
69835|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
69836|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
69837|NCT01955720|O15|Outcome|150 mg /Plc. 2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart.
69900|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
69842|NCT01955720|O10|Outcome|150 mg/1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
69843|NCT01955720|O9|Outcome|220 mg/Plc. 5g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
69844|NCT01955720|O8|Outcome|220 mg/5g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
69845|NCT01955720|O7|Outcome|220 mg/Plc. 1g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
69846|NCT01955720|O6|Outcome|220 mg/1g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
69847|NCT01955720|O5|Outcome|220 mg/Plc. 5g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
69848|NCT01955720|O4|Outcome|220 mg/5g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
69849|NCT01955720|O3|Outcome|220 mg/2.5g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
69850|NCT01955720|O2|Outcome|220 mg/Plc. 2.5g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
69851|NCT01955720|O1|Outcome|220 mg/2.5g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
69852|NCT01955720|O15|Outcome|150 mg /Plc. 2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart.
69853|NCT01955720|O14|Outcome|150 mg /2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart.
69854|NCT01955720|O13|Outcome|150 mg/Plc. 5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g
69855|NCT01955720|O12|Outcome|150 mg/5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
69856|NCT01955720|O11|Outcome|150 mg/Plc. 1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g
69857|NCT01955720|O10|Outcome|150 mg/1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
69858|NCT01955720|O9|Outcome|220 mg/Plc. 5g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
69859|NCT01955720|O8|Outcome|220 mg/5g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
69860|NCT01955720|O7|Outcome|220 mg/Plc. 1g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
69861|NCT01955720|O6|Outcome|220 mg/1g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
69862|NCT01955720|O5|Outcome|220 mg/Plc. 5g HS 45-64 Yrs|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
69863|NCT01955720|O4|Outcome|220 mg/5g HS 45-64 Yrs|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g
69864|NCT01955720|O3|Outcome|220 mg/2.5g HS 45-64 Yrs Re-exposure|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
69865|NCT01955720|O2|Outcome|220 mg/Plc. 2.5g HS 45−64 Years|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
69866|NCT01955720|O1|Outcome|220 mg/2.5g HS 45−64 Years|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
69867|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
69868|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
69869|NCT01955720|O6|Outcome|150 mg/1 g Mild Renal Impairment (RI)|Mild RI (creatinine clearance [CL] 60-90) with dabigatran (DE) 150 mg/Ida 1g
69870|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
69871|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
69872|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
69873|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
69874|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
69875|NCT01955720|O1|Outcome|On Treatment Group|during the treatment period.
69876|NCT01955720|O2|Outcome|Idarucizumab (Ida)|Idarucizumab (Ida).
69877|NCT01955720|O1|Outcome|Placebo|idarucizumab-matching placebo
69878|NCT01955720|E7|Reported Event|High (5g) Placebo Dose|Subjects with high (5g) placebo dose treatment
69879|NCT01955720|E6|Reported Event|Medium (2.5g) Placebo Dose|Subjects with medium (2.5g) placebo dose treatment
69880|NCT01955720|E5|Reported Event|Low (1g) Placebo Dose|Subjects with low (1g) placebo dose treatment
69881|NCT01955720|E4|Reported Event|High (5g) Idarucizumab Dose|Subjects with high (5g) idarucizumab dose treatment
69882|NCT01955720|E3|Reported Event|Medium (2.5g) Idarucizumab Dose|Subjects with medium (2.5g) idarucizumab dose treatment
69883|NCT01955720|E2|Reported Event|Low (1g) Idarucizumab Dose|Subjects with low 1g idarucizumab dose treatment
69884|NCT01955720|E1|Reported Event|Dabigatran Etexilate (DE)|subjects with Dabigatran etexilate (DE) treatment
69885|NCT01955707|B3|Baseline|Total|Total of all reporting groups
69886|NCT01955707|B2|Baseline|Natalizumab|300 mg single IV injection of natalizumab
69887|NCT01955707|B1|Baseline|Placebo|A single IV injection of placebo
69888|NCT01955707|P2|Participant Flow|Natalizumab|300 mg single IV injection of natalizumab
69889|NCT01955707|P1|Participant Flow|Placebo|A single intravenous (IV) injection of placebo
69890|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
69891|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
69892|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
69893|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
69894|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
69895|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
69896|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
69897|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
69898|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
69904|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
69905|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
69906|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
69907|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
69908|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
69909|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
69910|NCT01955707|E2|Reported Event|Natalizumab|300 mg single IV injection of natalizumab
69911|NCT01955707|E1|Reported Event|Placebo|A single IV injection of placebo
69912|NCT01955629|B1|Baseline|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
69913|NCT01955629|P1|Participant Flow|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg intravenous (IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant’s refusal of further treatment.
69914|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
69915|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
69916|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
69917|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
69992|NCT01955473|O1|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69918|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
69919|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
69920|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
69921|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
69922|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
69923|NCT01955629|E1|Reported Event|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg intravenous(IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant’s refusal of further treatment.
69924|NCT01955564|B8|Baseline|Total|Total of all reporting groups
69925|NCT01955564|B7|Baseline|Cohort 6|NW-3509a 30 mg NW-3509a: single dose
69926|NCT01955564|B6|Baseline|Cohort 5|"NW-3509a 20 mg
NW-3509a: single dose"
69927|NCT01955564|B5|Baseline|Cohort 4|"NW-3509a 10 mg
NW-3509a: single dose"
69928|NCT01955564|B4|Baseline|Cohort 3|"NW-3509a 5mg
NW-3509a: single dose"
69929|NCT01955564|B3|Baseline|Cohort 2|"NW-3509a 2mg
NW-3509a: single dose"
69930|NCT01955564|B2|Baseline|Cohort 1|"NW-3509a - 1mg
NW-3509a: single dose"
69931|NCT01955564|B1|Baseline|Placebo|placebo: single dose
69932|NCT01955564|P7|Participant Flow|Cohort 6|NW-3509a 30 mg, single dose
69933|NCT01955564|P6|Participant Flow|Cohort 5|NW-3509a 20 mg, single dose
69934|NCT01955564|P5|Participant Flow|Cohort 4|NW-3509a 10 mg, single dose
69935|NCT01955564|P4|Participant Flow|Cohort 3|NW-3509a 5mg, single dose
69936|NCT01955564|P3|Participant Flow|Cohort 2|NW-3509a 2mg, single dose
69937|NCT01955564|P2|Participant Flow|Cohort 1|NW-3509a - 1mg, single dose
69938|NCT01955564|P1|Participant Flow|Placebo|Placebo, single dose
69939|NCT01955564|O6|Outcome|Cohort 6|NW-3509a 30mg, single dose
69940|NCT01955564|O5|Outcome|Cohort 5|NW-3509a 20mg, single dose
69941|NCT01955564|O4|Outcome|Cohort 4|NW-3509a 10mg, single dose
69942|NCT01955564|O3|Outcome|Cohort 3|NW-3509a 5mg, single dose
69943|NCT01955564|O2|Outcome|Cohort 2|NW-3509a 2mg, single dose
69944|NCT01955564|O1|Outcome|Cohort 1|NW-3509a 1mg, single dose
69945|NCT01955564|O6|Outcome|Cohort 6|NW-3509a 30mg, single dose
69946|NCT01955564|O5|Outcome|Cohort 5|NW-3509a 20mg, single dose
69947|NCT01955564|O4|Outcome|Cohort 4|NW-3509a 10mg, single dose
69948|NCT01955564|O3|Outcome|Cohort 3|NW-3509a 5mg, single dose
69949|NCT01955564|O2|Outcome|Cohort 2|NW-3509a 2mg, single dose
69950|NCT01955564|O1|Outcome|Cohort 1|NW-3509a 1mg, single dose
69951|NCT01955564|O7|Outcome|Cohort 6|NW-3509a 30 mg, single dose
69952|NCT01955564|O6|Outcome|Cohort 5|NW-3509a 20 mg, single dose
69953|NCT01955564|O5|Outcome|Cohort 4|NW-3509a 10 mg, single dose
69954|NCT01955564|O4|Outcome|Cohort 3|NW-3509a 5mg, single dose
69955|NCT01955564|O3|Outcome|Cohort 2|NW-3509a 2mg, single dose
69956|NCT01955564|O2|Outcome|Cohort 1|NW-3509a - 1mg, single dose
69957|NCT01955564|O1|Outcome|Placebo|Placebo, single dose
69958|NCT01955564|E7|Reported Event|Cohort 6|NW-3509a 30 mg, single dose
69959|NCT01955564|E6|Reported Event|Cohort 5|NW-3509a 20 mg, single dose
69960|NCT01955564|E5|Reported Event|Cohort 4|NW-3509a 10 mg, single dose
69961|NCT01955564|E4|Reported Event|Cohort 3|NW-3509a 5mg, single dose
69962|NCT01955564|E3|Reported Event|Cohort 2|NW-3509a 2mg, single dose
69963|NCT01955564|E2|Reported Event|Cohort 1|NW-3509a 1mg, single dose
69964|NCT01955564|E1|Reported Event|Placebo|placebo, single dose
69965|NCT01955473|B6|Baseline|Total|Total of all reporting groups
69966|NCT01955473|B5|Baseline|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69967|NCT01955473|B4|Baseline|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69968|NCT01955473|B3|Baseline|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
71923|NCT01945970|E1|Reported Event|Black Tea Extract|Spray dried aqueous extract of a representative batch of black tea
69969|NCT01955473|B2|Baseline|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69970|NCT01955473|B1|Baseline|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69971|NCT01955473|P5|Participant Flow|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69972|NCT01955473|P4|Participant Flow|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69973|NCT01955473|P3|Participant Flow|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69974|NCT01955473|P2|Participant Flow|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69975|NCT01955473|P1|Participant Flow|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69976|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69977|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69978|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69979|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70203|NCT01955044|E1|Reported Event|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement"
69980|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69981|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69982|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69983|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69984|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69985|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69986|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69987|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69988|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69989|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69990|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69991|NCT01955473|O2|Outcome|Part A and B Combined|All subjects who were included in Part A and Part B. Sym004 administered by intravenous infusion at a dose of 6 mg/kg weekly, or 9 mg/kg at Week 1 followed by a maintenance dose of 6 mg/kg weekly, or 12 mg/kg weekly, or 18 mg/kg biweekly in Part A or 12 mg/kg by intravenous infusion weekly in Part B until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69993|NCT01955473|O2|Outcome|Part A and B Combined|All subjects who were included in Part A and Part B. Sym004 administered by intravenous infusion at a dose of 6 mg/kg weekly, or 9 mg/kg at Week 1 followed by a maintenance dose of 6 mg/kg weekly, or 12 mg/kg weekly, or 18 mg/kg biweekly in Part A or 12 mg/kg by intravenous infusion weekly in Part B until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69994|NCT01955473|O1|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69995|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69996|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69997|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69998|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
69999|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70000|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70001|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70002|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70026|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70003|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70004|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70005|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70006|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70007|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70008|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70009|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70010|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70011|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70012|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70013|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70014|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70015|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
71604|NCT01947907|P1|Participant Flow|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
70016|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70017|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70018|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70019|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70020|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70021|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70022|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70023|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70024|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70025|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70204|NCT01955005|B3|Baseline|Total|Total of all reporting groups
70027|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70028|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70029|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70030|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70031|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70032|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70033|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70034|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70035|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70036|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70037|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70038|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70039|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70040|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70041|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70042|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70043|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70044|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70045|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70046|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70047|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70048|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70049|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70050|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70051|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70052|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70053|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70054|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70055|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70056|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70057|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70058|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70059|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70060|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70061|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70062|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70063|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70064|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70065|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70066|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70067|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70068|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70069|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70070|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70071|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70072|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70073|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70074|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70075|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70076|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70077|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70078|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70079|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70080|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70081|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70082|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70083|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70084|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70085|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70086|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70087|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70088|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70089|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70090|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70091|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70092|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70093|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70094|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70095|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70096|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70097|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70098|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
94722|NCT01813721|O1|Outcome|Breast Cancer|
70099|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70100|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70101|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70102|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70103|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70104|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70105|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70106|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70107|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70108|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70109|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70110|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70111|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
71924|NCT01945944|B3|Baseline|Total|Total of all reporting groups
70112|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70113|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70114|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70115|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70116|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70117|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70118|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70119|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70120|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70121|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70150|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:
a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
70122|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70123|NCT01955473|E5|Reported Event|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70124|NCT01955473|E4|Reported Event|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70125|NCT01955473|E3|Reported Event|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70126|NCT01955473|E2|Reported Event|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70127|NCT01955473|E1|Reported Event|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
70128|NCT01955369|B1|Baseline|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
70129|NCT01955369|P1|Participant Flow|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
70130|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
70131|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
70132|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
70133|NCT01955369|E1|Reported Event|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
70134|NCT01955122|B3|Baseline|Total|Total of all reporting groups
70135|NCT01955122|B2|Baseline|Group B|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device) .
71607|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
70136|NCT01955122|B1|Baseline|Group A|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
70137|NCT01955122|P2|Participant Flow|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:
an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
70138|NCT01955122|P1|Participant Flow|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:
a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
70139|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:
an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
70140|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:
a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
70141|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:
an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
70142|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:
a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
70143|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:
an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.
Tandem Colonoscopy: Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order."
70144|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:
a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.
Tandem Colonoscopy: Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order."
70145|NCT01955122|O2|Outcome|Group B|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device).
70146|NCT01955122|O1|Outcome|Group A|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
70147|NCT01955122|O2|Outcome|Standard Colonoscopy|procedures performed with the Standard
70148|NCT01955122|O1|Outcome|EndoRings Colonoscopy|procedures performed with the EndoRings
70149|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:
an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
70151|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:
an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
70152|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:
a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
70153|NCT01955122|E2|Reported Event|Group B (Control Group)|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device).
70154|NCT01955122|E1|Reported Event|A (Study Group)|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
70155|NCT01955083|B3|Baseline|Total|Total of all reporting groups
70156|NCT01955083|B2|Baseline|Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring."
70157|NCT01955083|B1|Baseline|Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring."
70158|NCT01955083|P2|Participant Flow|Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Subjects receive pillar implant of the soft palate under local anesthesia as an outpatient procedure on sitting position. Using the delivery tool of the pillar implant system, the mucosa of the soft palate close to the hard palate-soft palate junction (approximate 0.5 cm) was punctured in the midline. The needle was inserted to the uvular muscle and moved parallel to the curve of the soft palate towards the tip of the uvula. After reaching the insertion point, the implant was delivered steadily after which the needle was withdrawn. This process was repeated for the second and third implants in the bilateral para-midline with a 0.2 cm horizontal distance from the first implant."
70159|NCT01955083|P1|Participant Flow|Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Subjects receive radiofrequency under local anesthesia as an outpatient procedure on sitting position. radiofrequency energy was delivered via a generator (Somnus® Model S2, Gyrus-ACMI Corporation, Maple Grove, MN, USA) with the power set to 10 watts and the maximal target temperature to 85°C. The needle electrode was inserted through the mucosa into the muscle layer at the entry points (approximately 1 cm below the hard palate-soft palate junction). The electrode was kept in place until 600 J had been delivered at the midline and 300 J at both para-midline sites (approximately 1 cm horizontal distance)."
70160|NCT01955083|O2|Outcome|Percentage of Good Response at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percentage of good response at 3 months after surgery was calculated."
70161|NCT01955083|O1|Outcome|Percentage of Good Response at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percentage of good response was calculated."
70162|NCT01955083|O2|Outcome|Percent Change in B1-Fmean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated."
70327|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70163|NCT01955083|O1|Outcome|Percent Change in B1-Fmean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated."
70164|NCT01955083|O2|Outcome|Percent Change in B1-Fpeak at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated."
70165|NCT01955083|O1|Outcome|Percent Change in B1-Fpeak at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated."
70166|NCT01955083|O2|Outcome|Percent Change in B1-Imean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated."
70167|NCT01955083|O1|Outcome|Percent Change in B1-Imean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated."
70168|NCT01955083|O2|Outcome|Percent Change in B1-Imax at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated."
70169|NCT01955083|O1|Outcome|Percent Change in B1-Imax at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated."
70170|NCT01955083|O2|Outcome|Percent Change in B1-SI at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated."
70171|NCT01955083|O1|Outcome|Percent Change in B1-SI at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated."
70202|NCT01955044|E2|Reported Event|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement"
70172|NCT01955083|O2|Outcome|Percent Change in Total-Fmean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated."
70173|NCT01955083|O1|Outcome|Percent Change in Total-Fmean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated."
70174|NCT01955083|O2|Outcome|Percent Change in Total-Fpeak at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated."
70175|NCT01955083|O1|Outcome|Percent Change in Total-Fpeak at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated."
70176|NCT01955083|O2|Outcome|Percent Change in Total-Imean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated."
70177|NCT01955083|O1|Outcome|Percent Change in Total-Imean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated."
70178|NCT01955083|O2|Outcome|Percent Change in Total-Imax at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated."
70179|NCT01955083|O1|Outcome|Percent Change in Total-Imax at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated."
70180|NCT01955083|O2|Outcome|Percent Change in Total-SI at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated."
70181|NCT01955083|O1|Outcome|Percent Change in Total-SI at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated."
70182|NCT01955083|O2|Outcome|Change in SOS Score at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Mean change (after value-before value) in SOS score at 3 months after surgery was calculated."
70183|NCT01955083|O1|Outcome|Change in SOS Score at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Mean change (after value-before value) in SOS score at 3 months after surgery was calculated."
71751|NCT01946542|E1|Reported Event|Placebo|
70184|NCT01955083|O2|Outcome|Change in VAS Score at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Mean change (after value-before value) in VAS score at 3 months after surgery was calculated."
70185|NCT01955083|O1|Outcome|Change in VAS Score at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Mean change (after value-before value) in VAS score at 3 months after surgery was calculated."
70186|NCT01955083|E2|Reported Event|Pillar Implant|"Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring."
70187|NCT01955083|E1|Reported Event|Radiofrequency|"Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring."
70188|NCT01955044|B4|Baseline|Total|Total of all reporting groups
70189|NCT01955044|B3|Baseline|Placebo|"the placebo is a drop that will be administered to ELBW infants.
placebo"
70190|NCT01955044|B2|Baseline|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement"
70191|NCT01955044|B1|Baseline|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement"
70192|NCT01955044|P3|Participant Flow|Placebo|"the placebo is a drop that will be administered to ELBW infants.
placebo"
70193|NCT01955044|P2|Participant Flow|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement"
70194|NCT01955044|P1|Participant Flow|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement"
70195|NCT01955044|O3|Outcome|Placebo|"the placebo is a drop that will be administered to ELBW infants.
placebo"
70196|NCT01955044|O2|Outcome|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement"
70197|NCT01955044|O1|Outcome|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement"
70198|NCT01955044|O3|Outcome|Placebo|"the placebo is a drop that will be administered to ELBW infants.
placebo"
70199|NCT01955044|O2|Outcome|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement"
70200|NCT01955044|O1|Outcome|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.
LCPUFA supplement"
70201|NCT01955044|E3|Reported Event|Placebo|"the placebo is a drop that will be administered to ELBW infants.
placebo"
70640|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
70205|NCT01955005|B2|Baseline|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.
Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
70206|NCT01955005|B1|Baseline|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.
My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
70207|NCT01955005|P2|Participant Flow|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.
Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
70208|NCT01955005|P1|Participant Flow|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.
My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
70209|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.
Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
70210|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.
My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
70211|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.
Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
70212|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.
My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
70213|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.
Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
71752|NCT01946529|B4|Baseline|Total|Total of all reporting groups
70214|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.
My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
70215|NCT01955005|E2|Reported Event|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.
Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
70216|NCT01955005|E1|Reported Event|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.
My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
70217|NCT01954771|B4|Baseline|Total|Total of all reporting groups
70218|NCT01954771|B3|Baseline|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70219|NCT01954771|B2|Baseline|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70220|NCT01954771|B1|Baseline|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70280|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70307|NCT01954160|B1|Baseline|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit
Symplicity Renal Denervation System"
70221|NCT01954771|P3|Participant Flow|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70222|NCT01954771|P2|Participant Flow|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70223|NCT01954771|P1|Participant Flow|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70224|NCT01954771|O3|Outcome|SMBG-7 Group|"SMBG: Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70225|NCT01954771|O2|Outcome|SMBG-4 Group|"SMBG: Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70226|NCT01954771|O1|Outcome|Control Group|"SMBG: Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70227|NCT01954771|O3|Outcome|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70228|NCT01954771|O2|Outcome|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70229|NCT01954771|O1|Outcome|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70230|NCT01954771|O3|Outcome|SMBG-7 Group|"SMBG: Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70231|NCT01954771|O2|Outcome|SMBG-4 Group|"SMBG: Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70232|NCT01954771|O1|Outcome|Control Group|"SMBG: Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70233|NCT01954771|O3|Outcome|SMBG-7 Group|"SMBG: Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70281|NCT01954251|O1|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70234|NCT01954771|O2|Outcome|SMBG-4 Group|"SMBG: Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70235|NCT01954771|O1|Outcome|Control Group|"SMBG: Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70236|NCT01954771|E3|Reported Event|SMBG-7 Group|"Capillary glucose level was measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70237|NCT01954771|E2|Reported Event|SMBG-4 Group|"Capillary glucose level was measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70238|NCT01954771|E1|Reported Event|Control Group|"Patients received conventional care and kept on their usual SMBG methods. Additionally, each patient also wore a CGMS device for 72h in the first week and the last week, respectively.
SMBG
CGMS: In this study, according to the protocol, all the patients followed their prespecified SMBG methods and periodically visited doctor, but therapies were not adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks."
70239|NCT01954745|B1|Baseline|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
70240|NCT01954745|P1|Participant Flow|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
70272|NCT01954251|P1|Participant Flow|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70388|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
70241|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
70242|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
70243|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
70282|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70308|NCT01954160|P2|Participant Flow|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation System"
70244|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
70245|NCT01954745|E1|Reported Event|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.
Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
70246|NCT01954628|B3|Baseline|Total|Total of all reporting groups
70247|NCT01954628|B2|Baseline|Placebo|"1 x Placebo capsule daily
Placebo: Placebo control"
70248|NCT01954628|B1|Baseline|AQX-1125 (200 mg)|"1 x AQX-1125 capsule daily
AQX-1125: Synthetic SHIP1 activator"
70249|NCT01954628|P2|Participant Flow|Placebo|Placebo (matching AQX-1125 capsule), oral, once daily for 12 weeks. Placebo control. All standard of care treatments for COPD were permitted throughout the study with the exception of Roflumilast and Theophylline.
70250|NCT01954628|P1|Participant Flow|AQX-1125 (200 mg)|AQX-1125 (200 mg capsule), oral once daily for 12 weeks. All standard of care treatments for COPD were permitted throughout the study with the exception of Roflumilast and Theophylline.
70251|NCT01954628|O3|Outcome|AQX-1125 Week 12|Week 12 PK Week 12 PK
70252|NCT01954628|O2|Outcome|AQX-1125 Week 4|AQX-1125 Week 4 PK
70253|NCT01954628|O1|Outcome|AQX-1125 Week 2|AQX-1125 Week 2 PK
70254|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
70255|NCT01954628|O1|Outcome|AQX-1125 (200mg)|1 x AQX-1125 capsule daily
70256|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
70257|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
70258|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
70259|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
70260|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
70261|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
70262|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
70263|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
70264|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
70265|NCT01954628|O1|Outcome|AQX-1125 (200mg)|1 x AQX-1125 capsule daily
70266|NCT01954628|E2|Reported Event|Placebo|"1 x Placebo capsule daily
Placebo: Placebo control"
70267|NCT01954628|E1|Reported Event|AQX-1125|"1 x AQX-1125 capsule daily
AQX-1125: Synthetic SHIP1 activator"
70268|NCT01954251|B3|Baseline|Total|Total of all reporting groups
70269|NCT01954251|B2|Baseline|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70270|NCT01954251|B1|Baseline|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70271|NCT01954251|P2|Participant Flow|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70389|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
70273|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70274|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70275|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70276|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70277|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70278|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70279|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70283|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70284|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70285|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70286|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70287|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70288|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70289|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70290|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70291|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70292|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70293|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70294|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70295|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70296|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70297|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70298|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70299|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70300|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70301|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70302|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70303|NCT01954251|E2|Reported Event|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
70304|NCT01954251|E1|Reported Event|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
70305|NCT01954160|B3|Baseline|Total|Total of all reporting groups
70306|NCT01954160|B2|Baseline|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation System"
70664|NCT01952665|B3|Baseline|Total|Total of all reporting groups
70309|NCT01954160|P1|Participant Flow|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit
Symplicity Renal Denervation System"
70310|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation System"
70311|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit
Symplicity Renal Denervation System"
70312|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation System"
70313|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit
Symplicity Renal Denervation System"
70314|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation System"
70315|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit
Symplicity Renal Denervation System"
70316|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation System"
70317|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit
Symplicity Renal Denervation System"
70318|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70319|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70320|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70321|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70322|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70323|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70324|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70325|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70326|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70390|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
70328|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70329|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70330|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70331|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70332|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70333|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70334|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70335|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70336|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70337|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70338|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70339|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70340|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70341|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70342|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70343|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70344|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70345|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70346|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70347|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70348|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70349|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70350|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70351|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70352|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70353|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70354|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70355|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70356|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70357|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70358|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70359|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70360|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation: Renal denervation"
70361|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit
Symplicity Renal Denervation: Renal denervation"
70362|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation System"
70363|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit
Symplicity Renal Denervation System"
70364|NCT01954160|E2|Reported Event|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit
Symplicity Renal Denervation System"
70365|NCT01954160|E1|Reported Event|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit
Symplicity Renal Denervation System"
70366|NCT01954121|B3|Baseline|Total Title|
70367|NCT01954121|B2|Baseline|Carbamazepine-IR (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
70368|NCT01954121|B1|Baseline|Levetiracetam (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
70369|NCT01954121|P2|Participant Flow|Carbamazepine-IR|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
70370|NCT01954121|P1|Participant Flow|Levetiracetam|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
70371|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
70638|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
94723|NCT01813721|O4|Outcome|Comprehensive Cancer Center|
70372|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
70373|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
70374|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
70375|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
70376|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
70377|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
70378|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
70379|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
70380|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
70381|NCT01954121|E2|Reported Event|Carbamazepine-IR (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
70382|NCT01954121|E1|Reported Event|Levetiracetam (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
70383|NCT01953354|B3|Baseline|Total|Total of all reporting groups
70384|NCT01953354|B2|Baseline|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
70385|NCT01953354|B1|Baseline|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
70386|NCT01953354|P2|Participant Flow|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
70387|NCT01953354|P1|Participant Flow|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
70391|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
70392|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
70393|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
70394|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
70395|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
70396|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
70397|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
70398|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
70399|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
70400|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
70401|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
70402|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
70403|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
70404|NCT01953354|E2|Reported Event|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
70405|NCT01953354|E1|Reported Event|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
70406|NCT01953328|B9|Baseline|Total|Total of all reporting groups
70407|NCT01953328|B8|Baseline|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70875|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70408|NCT01953328|B7|Baseline|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70409|NCT01953328|B6|Baseline|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70410|NCT01953328|B5|Baseline|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70411|NCT01953328|B4|Baseline|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70412|NCT01953328|B3|Baseline|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70413|NCT01953328|B2|Baseline|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70414|NCT01953328|B1|Baseline|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70415|NCT01953328|P8|Participant Flow|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70416|NCT01953328|P7|Participant Flow|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70417|NCT01953328|P6|Participant Flow|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70418|NCT01953328|P5|Participant Flow|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70419|NCT01953328|P4|Participant Flow|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70420|NCT01953328|P3|Participant Flow|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70421|NCT01953328|P2|Participant Flow|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70422|NCT01953328|P1|Participant Flow|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70423|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
71021|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
70424|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70425|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70426|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70427|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70428|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70429|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70430|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70431|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70432|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70433|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70434|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70435|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70639|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
70436|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70437|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70438|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70439|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70440|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70441|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70442|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70443|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70444|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70445|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70446|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70447|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70448|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70449|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70450|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70451|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70452|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70453|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70454|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70455|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70456|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70457|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70458|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70459|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70460|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70461|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70462|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70463|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70464|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70465|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70466|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70467|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70468|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70469|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70470|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70471|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70472|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70473|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70474|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70475|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70476|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70477|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70478|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70479|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70480|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70481|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70482|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70483|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70484|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70485|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70486|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70487|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70488|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70489|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70490|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70491|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70492|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70493|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70494|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70495|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70496|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70497|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70498|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70499|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70500|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70501|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70502|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70503|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70504|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70505|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70506|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70507|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70508|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70509|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70510|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70511|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70512|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70513|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70514|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70515|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70516|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70517|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70518|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70519|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70520|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70521|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70522|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70523|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70524|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70525|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70526|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70527|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70528|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70529|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70530|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70531|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70532|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70533|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70534|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70535|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70536|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70537|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70538|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70539|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70540|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70541|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70542|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70543|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70544|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70545|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70546|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70547|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70548|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70549|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70550|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70551|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70552|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70553|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70554|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70555|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70556|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70557|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70558|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70559|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70560|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70561|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70562|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70563|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70564|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70565|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70566|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70567|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70568|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70569|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70570|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70571|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70572|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70573|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70574|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70575|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70576|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70577|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70578|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70579|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70580|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70581|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70582|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70583|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70584|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70585|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70586|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70587|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70588|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70589|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70590|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70591|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70592|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70593|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70594|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70595|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70596|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70597|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70598|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70599|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70600|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70601|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70602|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70603|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70604|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70605|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70606|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70607|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70608|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70609|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70610|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70611|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70612|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70613|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70614|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70615|NCT01953328|E8|Reported Event|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70616|NCT01953328|E7|Reported Event|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70617|NCT01953328|E6|Reported Event|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
70618|NCT01953328|E5|Reported Event|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
70619|NCT01953328|E4|Reported Event|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
70620|NCT01953328|E3|Reported Event|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
70621|NCT01953328|E2|Reported Event|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
70622|NCT01953328|E1|Reported Event|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
70623|NCT01953237|B3|Baseline|Total|Total of all reporting groups
70624|NCT01953237|B2|Baseline|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
70625|NCT01953237|B1|Baseline|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
70626|NCT01953237|P2|Participant Flow|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
70627|NCT01953237|P1|Participant Flow|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
70681|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
71605|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)
Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
70628|NCT01953237|O2|Outcome|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
70629|NCT01953237|O1|Outcome|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
70630|NCT01953237|E2|Reported Event|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
70631|NCT01953237|E1|Reported Event|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
70632|NCT01953081|B3|Baseline|Total|Total of all reporting groups
70633|NCT01953081|B2|Baseline|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
70634|NCT01953081|B1|Baseline|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
70635|NCT01953081|P2|Participant Flow|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
70636|NCT01953081|P1|Participant Flow|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
70637|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
70641|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
70642|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
70643|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
70644|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
70645|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
70646|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
70647|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
70648|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
70649|NCT01953081|E2|Reported Event|Metoclopramide|"Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
Metoclopramide"
70650|NCT01953081|E1|Reported Event|TD-8954|"TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
TD-8954"
70651|NCT01952834|B1|Baseline|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
70652|NCT01952834|P1|Participant Flow|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
70653|NCT01952834|O1|Outcome|Probiotic Supplementation|The measurement of IL-2 represents the change in IL-12 +/- standard deviation of the change following 6 weeks of probiotic supplementation.
70654|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
70655|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
70656|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
70657|NCT01952834|E1|Reported Event|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
70658|NCT01952691|B1|Baseline|Kinesiotaping|"all patients were implemented a kinesiotaping to align the hallux to correct position
kinesiotaping: correction method was used to align hallux."
70659|NCT01952691|P1|Participant Flow|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.
kinesiotaping: correction method was used to align hallux's adduction position."
70660|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.
kinesiotaping: correction method was used to align hallux's adduction position."
70661|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.
kinesiotaping: correction method was used to align hallux's adduction position."
70662|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.
kinesiotaping: correction method was used to align hallux's adduction position."
70663|NCT01952691|E1|Reported Event|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.
kinesiotaping: correction method was used to align hallux's adduction position."
70665|NCT01952665|B2|Baseline|Lotrafilcon B Then Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70666|NCT01952665|B1|Baseline|Comfilcon A Then Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70667|NCT01952665|P2|Participant Flow|Lotrafilcon B Then Comfilcon A|Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70668|NCT01952665|P1|Participant Flow|Comfilcon A Then Lotrafilcon B|Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70669|NCT01952665|O3|Outcome|Habitual Lens|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
70670|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70671|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70672|NCT01952665|O3|Outcome|Habitual Lens|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
70673|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70674|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70675|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70676|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70677|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70678|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70679|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70680|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70845|NCT01952145|B3|Baseline|Total|Total of all reporting groups
71925|NCT01945944|B2|Baseline|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%)"
70682|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70683|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70684|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70685|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70686|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70687|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70688|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70689|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70690|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70691|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70692|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70693|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70694|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70876|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70695|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70696|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70697|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70698|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70699|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70700|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70701|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70702|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70703|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70704|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70705|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70706|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70707|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70708|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70709|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70710|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70711|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70712|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70713|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70714|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70715|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70716|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70717|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70718|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70719|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70720|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70721|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70722|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70723|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70724|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70725|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70726|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70727|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70728|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70729|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70730|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70731|NCT01952665|O2|Outcome|Habitual Lenses|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
70732|NCT01952665|O1|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70733|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70734|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70735|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70736|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70737|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70738|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70739|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70740|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70741|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70742|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70743|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70744|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70745|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70746|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70747|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70748|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70749|NCT01952665|O2|Outcome|Habitual Lenses|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
70750|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70751|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70752|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70753|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70754|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70819|NCT01952418|B2|Baseline|"Large Monitor (32)"|"Endoscopists in this arm will perform colonoscopy using the large size video monitor (32)."
70755|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70756|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70757|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70758|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70759|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70760|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70761|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70762|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70763|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70764|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70765|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70766|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70767|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70768|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70769|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70770|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70771|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70772|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70773|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70774|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70775|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70776|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70777|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70778|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70779|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70780|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70781|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70782|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70783|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70784|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70785|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70786|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70787|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70788|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70789|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70790|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70791|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70792|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70793|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70794|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70795|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70796|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70797|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70798|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70799|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70800|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70801|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70802|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
70803|NCT01952665|E2|Reported Event|Lotrafilcon B|"Daily wear soft contact lens lotrafilcon B
comfilcon A: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period."
70804|NCT01952665|E1|Reported Event|Comfilcon A|"Daily wear soft contact lens comfilcon A
lotrafilcon B: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period."
70805|NCT01952600|B4|Baseline|Total|Total of all reporting groups
70806|NCT01952600|B3|Baseline|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
70807|NCT01952600|B2|Baseline|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
70808|NCT01952600|B1|Baseline|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
70809|NCT01952600|P3|Participant Flow|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
70810|NCT01952600|P2|Participant Flow|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
70811|NCT01952600|P1|Participant Flow|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
70812|NCT01952600|O3|Outcome|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
70813|NCT01952600|O2|Outcome|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
70814|NCT01952600|O1|Outcome|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
70815|NCT01952600|E3|Reported Event|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
70816|NCT01952600|E2|Reported Event|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
70817|NCT01952600|E1|Reported Event|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
70818|NCT01952418|B3|Baseline|Total|Total of all reporting groups
70872|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70820|NCT01952418|B1|Baseline|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
70821|NCT01952418|P2|Participant Flow|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
70822|NCT01952418|P1|Participant Flow|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
70823|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
70824|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
70825|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
70826|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
70827|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
70828|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
70829|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
70830|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
70831|NCT01952418|E2|Reported Event|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
70832|NCT01952418|E1|Reported Event|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
70833|NCT01952366|B1|Baseline|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
70834|NCT01952366|P1|Participant Flow|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
70835|NCT01952366|O1|Outcome|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
70836|NCT01952366|O2|Outcome|Remission in Depressed Patients|Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a remission (MADRS score of 9 or less) by the end of their hospital stay.
70837|NCT01952366|O1|Outcome|Response in Depressed Patients|Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a response (50% improvement of the MADRS score) during stay in the hospital.
70838|NCT01952366|E1|Reported Event|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
70839|NCT01952301|B1|Baseline|Xenogeneic Collagen Matrix Versus Free Gingival Graft|free gingival graft versus a xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
70840|NCT01952301|P1|Participant Flow|XCM Versus FGG|xenogeneic collagen matrix versus free gingival graft
70841|NCT01952301|O2|Outcome|Xenogeneic Collagen Matrix|xenogeneic collagen matrix over an apically positioned flap to generate keratinized tissue
70842|NCT01952301|O1|Outcome|Free Gingival Graft|free gingival graft over an apically positioned flap used to generate keratinized tissue
70843|NCT01952301|E2|Reported Event|Xenogeneic Collagen Matrix|xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
70844|NCT01952301|E1|Reported Event|Free Gingival Graft|free gingival graft over an apically positioned flap used to generate keratinized tissue
70846|NCT01952145|B2|Baseline|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70847|NCT01952145|B1|Baseline|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70848|NCT01952145|P2|Participant Flow|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70849|NCT01952145|P1|Participant Flow|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70873|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70874|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
94724|NCT01813721|O3|Outcome|Private Center|
70850|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70851|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70852|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70853|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70854|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70855|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70856|NCT01952145|E2|Reported Event|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70857|NCT01952145|E1|Reported Event|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
70858|NCT01952080|B5|Baseline|Total|Total of all reporting groups
70859|NCT01952080|B4|Baseline|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70860|NCT01952080|B3|Baseline|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70861|NCT01952080|B2|Baseline|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70862|NCT01952080|B1|Baseline|Standard of Care|SOC- no teduglutide therapy
70863|NCT01952080|P4|Participant Flow|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70864|NCT01952080|P3|Participant Flow|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70865|NCT01952080|P2|Participant Flow|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70866|NCT01952080|P1|Participant Flow|Standard of Care|SOC- no teduglutide therapy
70867|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70868|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70869|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70870|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
70871|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70877|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70878|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
70879|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70880|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70881|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70882|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
70883|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70884|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70885|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70886|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
70887|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70888|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70889|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70890|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
70891|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70892|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70893|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70894|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
70895|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70896|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70897|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70898|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
70899|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70900|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70901|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70902|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
70903|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70904|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70905|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70906|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
70907|NCT01952080|E4|Reported Event|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
70908|NCT01952080|E3|Reported Event|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
70909|NCT01952080|E2|Reported Event|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
70910|NCT01952080|E1|Reported Event|Standard of Care|SOC- no teduglutide therapy
70911|NCT01951950|B3|Baseline|Total|Total of all reporting groups
70912|NCT01951950|B2|Baseline|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
70913|NCT01951950|B1|Baseline|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
70914|NCT01951950|P2|Participant Flow|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
70915|NCT01951950|P1|Participant Flow|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
70916|NCT01951950|O2|Outcome|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
70917|NCT01951950|O1|Outcome|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
71036|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
70918|NCT01951950|E2|Reported Event|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
70919|NCT01951950|E1|Reported Event|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
70920|NCT01951820|B3|Baseline|Total|Total of all reporting groups
70921|NCT01951820|B2|Baseline|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.
Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
70922|NCT01951820|B1|Baseline|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.
Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
70923|NCT01951820|P2|Participant Flow|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.
Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
70924|NCT01951820|P1|Participant Flow|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.
Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
70925|NCT01951820|O2|Outcome|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.
Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
70926|NCT01951820|O1|Outcome|Benzocaine|"Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.
Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
71022|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
70927|NCT01951820|E2|Reported Event|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.
Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
70928|NCT01951820|E1|Reported Event|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.
Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
70929|NCT01951703|B3|Baseline|Total|Total of all reporting groups
70930|NCT01951703|B2|Baseline|Test/Control|Subjects who received Test lens, senofilcon A for the first two weeks of the study and then received Control lens, senofilcon A in the last two weeks of the study.
70931|NCT01951703|B1|Baseline|Control/Test|Subjects who received Control lens, senofilcon A for the first two weeks of the study and then received Test lens, senofilcon A in the last two weeks of the study.
70932|NCT01951703|P2|Participant Flow|Test/Control|Subjects that received Test lens, senofilcon A for the first two weeks and then received Control lens senofilcon A in the last two weeks of the study.
70933|NCT01951703|P1|Participant Flow|Control/Test|Subjects that received Control lens, senofilcon A for the first two weeks and then received Test lens senofilcon A in the last two weeks of the study.
70934|NCT01951703|O2|Outcome|Test, Senofilcon A|Subjects who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
70935|NCT01951703|O1|Outcome|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
70936|NCT01951703|O2|Outcome|Test, Senofilcon A|Subject who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
70937|NCT01951703|O1|Outcome|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
70938|NCT01951703|E2|Reported Event|Test, Senofilcon A|Subjects who received Test lens senofilcon A in either the first two weeks or the last two weeks of the study,
70939|NCT01951703|E1|Reported Event|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
70940|NCT01951651|B3|Baseline|Total|Total of all reporting groups
70959|NCT01951586|P1|Participant Flow|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70941|NCT01951651|B2|Baseline|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months
Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70942|NCT01951651|B1|Baseline|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months
Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70943|NCT01951651|P2|Participant Flow|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months
Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70944|NCT01951651|P1|Participant Flow|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months
Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70945|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months
Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70946|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months
Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70947|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months
Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70948|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months
Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
71005|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
70949|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months
Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70950|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months
Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70951|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months
Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70952|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months
Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70953|NCT01951651|E2|Reported Event|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months
Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70996|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
70954|NCT01951651|E1|Reported Event|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months
Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
70955|NCT01951586|B3|Baseline|Total|Total of all reporting groups
70956|NCT01951586|B2|Baseline|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70957|NCT01951586|B1|Baseline|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70958|NCT01951586|P2|Participant Flow|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
71006|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
94725|NCT01813721|O2|Outcome|General Hospital|
70960|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70961|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70962|NCT01951586|O1|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70963|NCT01951586|O1|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70964|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70965|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70966|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70967|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70968|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70969|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70970|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70971|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70972|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70973|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70974|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70975|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70976|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
71409|NCT01949155|B2|Baseline|Sham|"Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery."
70977|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70978|NCT01951586|O2|Outcome|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70979|NCT01951586|O1|Outcome|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70980|NCT01951586|E2|Reported Event|Denosumab|Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received denosumab as often as Q3W while receiving Q3W chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
70981|NCT01951586|E1|Reported Event|Placebo|Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants may have received placebo as often as once every 3 weeks (Q3W) while receiving Q3W chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W.
70982|NCT01951573|B1|Baseline|Overall|Delefilcon A MF and AOAMF contact lenses worn during Period 1 and Period 2 in a crossover assignment.
70983|NCT01951573|P2|Participant Flow|AOAMF, Then Delefilcon A MF|Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
70984|NCT01951573|P1|Participant Flow|Delefilcon A MF, Then AOAMF|Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
70985|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
70986|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
70987|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
70988|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
70989|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
70990|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
70991|NCT01951573|E2|Reported Event|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
70992|NCT01951573|E1|Reported Event|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
70993|NCT01951417|B1|Baseline|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
70994|NCT01951417|P1|Participant Flow|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
70995|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71049|NCT01951066|E1|Reported Event|All Participants|
70997|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
70998|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
70999|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71000|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71001|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71002|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71003|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71004|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71007|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71008|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71009|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71010|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71011|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71012|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71013|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71014|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71015|NCT01951417|E1|Reported Event|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)"
71016|NCT01951170|B1|Baseline|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71017|NCT01951170|P1|Participant Flow|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 milligrams (mg) was administered subcutaneously once weekly for 24 weeks"
71018|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71019|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71020|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71023|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71024|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71025|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71026|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71027|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71028|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71029|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71030|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71031|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71032|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71033|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71034|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71035|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71491|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71037|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
71038|NCT01951170|E1|Reported Event|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: Tocilizumab was administered 162 mg subcutaneously once weekly for 24 weeks"
71039|NCT01951092|B1|Baseline|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
71040|NCT01951092|P1|Participant Flow|Single Arm Intervention Study|"All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
Text messaging"
71041|NCT01951092|O1|Outcome|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
71042|NCT01951092|O1|Outcome|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
71043|NCT01951092|E1|Reported Event|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
71044|NCT01951066|B1|Baseline|All Participants|
71045|NCT01951066|P2|Participant Flow|Group 2 (Anti-VEGF/Dexamethasone Implant)|"Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.
Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant
Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent"
71046|NCT01951066|P1|Participant Flow|Group 1 (Dexamethasone Implant/Anti-VEGF)|"Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.
Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant
Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent"
71047|NCT01951066|O2|Outcome|Anti-VEGF Agent|Patients received PRN injections of an Anti-VEGF agent
71048|NCT01951066|O1|Outcome|Dexamethasone Implant|Patients received an injection of an dexamethasone implant
71050|NCT01950741|B1|Baseline|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
71051|NCT01950741|P1|Participant Flow|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
71052|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
71053|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
71054|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
71055|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
71056|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
71057|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
71058|NCT01950741|E1|Reported Event|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.
Among 48 patients enrolled, one patient withdrew the consent before undergoing the first injection. Therefore the adverse event was assessed in 47 patients."
71059|NCT01950663|B1|Baseline|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.
RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
71060|NCT01950663|P1|Participant Flow|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.
RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
71061|NCT01950663|O1|Outcome|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.
RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
71062|NCT01950663|E1|Reported Event|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.
RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
71063|NCT01950364|B3|Baseline|Total|Total of all reporting groups
71064|NCT01950364|B2|Baseline|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71065|NCT01950364|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71066|NCT01950364|P2|Participant Flow|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 milligram (mg), capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71067|NCT01950364|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 milligram per kilogram (mg/kg), injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71068|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71069|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71070|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71071|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71433|NCT01949142|E1|Reported Event|OTO-201 Single, Intratympanic Injection|OTO-201: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery.
71072|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71073|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71074|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71075|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71076|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71077|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71078|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71079|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71080|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71081|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71082|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71083|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71084|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71085|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71086|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71087|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71088|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71089|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71090|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71091|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71092|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71093|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71094|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71095|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71096|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71097|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
72671|NCT01941498|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
71098|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71099|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71100|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71101|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71102|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71103|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71104|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71105|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71106|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71107|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71108|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71109|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71110|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71111|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71112|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71113|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71114|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71115|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71116|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71117|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71118|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71119|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71120|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71121|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71122|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71123|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
72672|NCT01941498|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
71124|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71125|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71126|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71127|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71128|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71129|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71130|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71131|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71132|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71133|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71134|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71135|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71136|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71137|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71138|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71139|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71140|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71141|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71142|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71143|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71144|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71145|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71146|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71147|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71148|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71149|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
72673|NCT01941498|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
71150|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71151|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71152|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71153|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71154|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71155|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71156|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71157|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71158|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71159|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71160|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71161|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71162|NCT01950364|E2|Reported Event|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
71163|NCT01950364|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
71164|NCT01950078|B3|Baseline|Total|Total of all reporting groups
71165|NCT01950078|B2|Baseline|Healthy Volunteers Group|grouped by healthy college students
71166|NCT01950078|B1|Baseline|Surgical Patients|grouped by receiving surgery
71167|NCT01950078|P2|Participant Flow|Healthy Volunteers Group|grouped by healthy college students
71168|NCT01950078|P1|Participant Flow|Surgical Patients|grouped by receiving surgery
71169|NCT01950078|O2|Outcome|Healthy Volunteers Group|grouped by healthy college students
71170|NCT01950078|O1|Outcome|Surgical Patients|grouped by receiving surgery
71171|NCT01950078|O2|Outcome|Healthy Volunteers Group|grouped by healthy college students
71172|NCT01950078|O1|Outcome|Surgical Patients|grouped by receiving surgery
71173|NCT01950078|E2|Reported Event|Healthy Volunteers Group|grouped by healthy college students
71174|NCT01950078|E1|Reported Event|Surgical Patients|grouped by receiving surgery
71175|NCT01949870|B1|Baseline|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)
For each 21-day cycle:
Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
71176|NCT01949870|P1|Participant Flow|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)
For each 21-day cycle:
Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
71177|NCT01949870|O1|Outcome|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)
For each 21-day cycle:
Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
71178|NCT01949870|E1|Reported Event|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)
For each 21-day cycle:
Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
71179|NCT01949545|B5|Baseline|Total|Total of all reporting groups
71180|NCT01949545|B4|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71181|NCT01949545|B3|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71453|NCT01948908|B1|Baseline|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71182|NCT01949545|B2|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71183|NCT01949545|B1|Baseline|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71184|NCT01949545|P4|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71185|NCT01949545|P3|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71186|NCT01949545|P2|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71350|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71187|NCT01949545|P1|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71188|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71189|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71190|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71191|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71192|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71193|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71465|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71194|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71195|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71196|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71197|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71198|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71199|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71200|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71201|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71202|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71203|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71204|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71205|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71454|NCT01948908|P3|Participant Flow|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71206|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71207|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71208|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71209|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71210|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71211|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71212|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71213|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71214|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71215|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71216|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71217|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71455|NCT01948908|P2|Participant Flow|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71218|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71219|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71220|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71221|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71222|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71223|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71224|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71225|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71226|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71227|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71228|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71229|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71456|NCT01948908|P1|Participant Flow|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71230|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71231|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71232|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71233|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71234|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71235|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71236|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71237|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71238|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71239|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71240|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71241|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71457|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71242|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71243|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71244|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71245|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71246|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71247|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71248|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71249|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71250|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71251|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71252|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71253|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71458|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71254|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71255|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71256|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71257|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71258|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71259|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71260|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71261|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71262|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71263|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71264|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71265|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71459|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71266|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71267|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71268|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71269|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71270|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71271|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71272|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71273|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71274|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71275|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71276|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71277|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71460|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71278|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71279|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71280|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71281|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71282|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71283|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71284|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71285|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71286|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71287|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71288|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71289|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71461|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71290|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71291|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71292|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71293|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71294|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71295|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71296|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71297|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71298|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71299|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71300|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71301|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71462|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71302|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71303|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71304|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71305|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71306|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71307|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71308|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71309|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71310|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71311|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71312|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71313|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71463|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71314|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71315|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71316|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71317|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71318|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71319|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71320|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71321|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71322|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71323|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71324|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71325|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71464|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71326|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71327|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71328|NCT01949545|E4|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71329|NCT01949545|E3|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71330|NCT01949545|E2|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71331|NCT01949545|E1|Reported Event|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
71332|NCT01949532|B3|Baseline|Total|Total of all reporting groups
71333|NCT01949532|B2|Baseline|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71334|NCT01949532|B1|Baseline|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71335|NCT01949532|P2|Participant Flow|End Stage Renal Disease|Participants with end-stage renal disease (on hemodialysis) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.
71336|NCT01949532|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (creatinine clearance [CrCl] ≥ 75 mL/min) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.
71337|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71338|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71339|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71340|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71341|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71342|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71343|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71344|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71345|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71346|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71347|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71348|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71349|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
94726|NCT01813721|O1|Outcome|University Hospital|
71351|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71352|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71353|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71354|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71355|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71356|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71357|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71358|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71359|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71360|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71361|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71362|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71363|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71364|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71365|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71366|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71367|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71368|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71369|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71370|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
94727|NCT01813721|O2|Outcome|> 10 Years|
71371|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71372|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71373|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71374|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71375|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71376|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71377|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71378|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71379|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71380|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71381|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71382|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71383|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71384|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71385|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71386|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71387|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71388|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71389|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71390|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71391|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71392|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71393|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71394|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71395|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71396|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71397|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71398|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71399|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71400|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71401|NCT01949532|E2|Reported Event|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71402|NCT01949532|E1|Reported Event|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
71403|NCT01949389|B1|Baseline|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.
Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
71404|NCT01949389|P1|Participant Flow|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.
Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
71405|NCT01949389|O1|Outcome|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.
Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
71406|NCT01949389|O1|Outcome|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.
Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
71407|NCT01949389|E1|Reported Event|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.
Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
71408|NCT01949155|B3|Baseline|Total|Total of all reporting groups
71410|NCT01949155|B1|Baseline|OTO-201|"OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
71411|NCT01949155|P2|Participant Flow|Sham|"Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery."
71412|NCT01949155|P1|Participant Flow|OTO-201|"OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
71413|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery"
71414|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
71415|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery"
71416|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
71417|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery."
71418|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
71419|NCT01949155|E2|Reported Event|Sham|"Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery."
71420|NCT01949155|E1|Reported Event|OTO-201|"OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
71421|NCT01949142|B3|Baseline|Total|Total of all reporting groups
71422|NCT01949142|B2|Baseline|Sham|"Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery."
71423|NCT01949142|B1|Baseline|OTO-201|"OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
71424|NCT01949142|P2|Participant Flow|Sham|"Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery."
71425|NCT01949142|P1|Participant Flow|OTO-201|"OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
71426|NCT01949142|O2|Outcome|Sham|Sham: Simulated single, intratympanic injection: One sham injection into each ear during surgery.
71427|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
71428|NCT01949142|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery."
71429|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
71430|NCT01949142|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery."
71431|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
71432|NCT01949142|E2|Reported Event|Sham-Simulated Single, Intratympanic Injection|Sham: One sham injection into each ear during surgery.
71434|NCT01949051|B1|Baseline|Placebo/Levocabastine|Participants received placebo/ Levo at a dose of 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) into each nostril or 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days each, in a crossover design. Treatment was given in one of six sequences in Periods 1, 2, and 3, (14 to 20 day washout period between treatments): ABC, BCA, CAB, ACB, BAC, CBA (A, Levo 200µg; B, Levo 400µg: C, Placebo). On Day 8 of each treatment period (approximately 12 hours post dosing for treatment A and 24 hours post dosing for treatment B and C), participants entered the environmental exposure chamber (EEC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit within 7 to 14 day after their final dose, and the overall duration for participation in the study (screening to follow-up) was 13 weeks.
71435|NCT01949051|P6|Participant Flow|Sequence 6: Placebo, Levo 400µg and Levo 200µg|Participants received placebo, Levo 400µg and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
71436|NCT01949051|P5|Participant Flow|Sequence 5: Levo 400µg, Levo 200µg and Placebo|Participants received Levo 400µg, Levo 200µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
71437|NCT01949051|P4|Participant Flow|Sequence 4: Levo 200µg, Placebo, and Levo 400µg|Participants received Levo 200µg, placebo, and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
71438|NCT01949051|P3|Participant Flow|Sequence 3: Placebo, Levo 200µg and Levo 400µg|Participants received placebo, Levo 200µg and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
71439|NCT01949051|P2|Participant Flow|Sequence 2: Levo 400µg, Placebo and Levo 200µg|Participants received Levo 400µg, placebo and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
94728|NCT01813721|O1|Outcome|≤ 10 Years|
71440|NCT01949051|P1|Participant Flow|Sequence 1: Levo 200 µg, Levo 400µg, Placebo|Participants received levocabastine (Levo) 200 micrograms (µg), Levo 400µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg once daily (OD) in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg twice daily (BID) in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
71441|NCT01949051|O3|Outcome|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
71442|NCT01949051|O2|Outcome|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
71443|NCT01949051|O1|Outcome|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
71444|NCT01949051|O3|Outcome|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
71445|NCT01949051|O2|Outcome|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
71446|NCT01949051|O1|Outcome|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
71447|NCT01949051|E3|Reported Event|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
71448|NCT01949051|E2|Reported Event|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
71449|NCT01949051|E1|Reported Event|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
71450|NCT01948908|B4|Baseline|Total|Total of all reporting groups
71451|NCT01948908|B3|Baseline|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71452|NCT01948908|B2|Baseline|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71562|NCT01948076|O1|Outcome|Resident Without GE Vscan|baseline physical exam use
71466|NCT01948908|E3|Reported Event|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71467|NCT01948908|E2|Reported Event|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71468|NCT01948908|E1|Reported Event|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
71469|NCT01948830|B3|Baseline|Total|Total of all reporting groups
71470|NCT01948830|B2|Baseline|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71471|NCT01948830|B1|Baseline|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71472|NCT01948830|P2|Participant Flow|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71473|NCT01948830|P1|Participant Flow|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71474|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71475|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71476|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71477|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71478|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71479|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71480|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71481|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71482|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71483|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71484|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71485|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71486|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71487|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71488|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71489|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71490|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71492|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71493|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71494|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71495|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71496|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71497|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71498|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71499|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71500|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71501|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71502|NCT01948830|E2|Reported Event|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
71503|NCT01948830|E1|Reported Event|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
71504|NCT01948791|B1|Baseline|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
71505|NCT01948791|P1|Participant Flow|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
71506|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
71507|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
71508|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
71509|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
71510|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
71511|NCT01948791|E1|Reported Event|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
71512|NCT01948518|B1|Baseline|Sildenafil|"20 mg of oral sildenafil, single dose at baseline
Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
71513|NCT01948518|P1|Participant Flow|Sildenafil|"20 mg of oral sildenafil, single dose at baseline
Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
71514|NCT01948518|O1|Outcome|Sildenafil|"20 mg of oral sildenafil, single dose at baseline
Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
71515|NCT01948518|O1|Outcome|Sildenafil|"20 mg of oral sildenafil, single dose at baseline
Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
71516|NCT01948518|E1|Reported Event|Sildenafil|"20 mg of oral sildenafil, single dose at baseline
Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
71517|NCT01948375|B3|Baseline|Total|Total of all reporting groups
71518|NCT01948375|B2|Baseline|Real Needle - Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71519|NCT01948375|B1|Baseline|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71520|NCT01948375|P2|Participant Flow|Placebo Needle - Real Needle|"Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial.
placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
71627|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71521|NCT01948375|P1|Participant Flow|Real Needle- Placebo Needle|"Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial.
real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
71522|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71523|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71524|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71563|NCT01948076|E2|Reported Event|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
71564|NCT01948076|E1|Reported Event|Resident Without GE Vscan|baseline physical exam use
71565|NCT01948063|B3|Baseline|Total|Total of all reporting groups
71525|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71526|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.
real needle- placebo needle: All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71527|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.
placebo needle - real needle: All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71528|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71682|NCT01947491|B2|Baseline|Vehicle Spray|"Vehicle Spray twice daily for 28 days
Vehicle Spray"
71529|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71530|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71531|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
71532|NCT01948375|E2|Reported Event|Placebo Needle - Real Needle|"Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial.
placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
71566|NCT01948063|B2|Baseline|Ubiquinol|Patients will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
71606|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71533|NCT01948375|E1|Reported Event|Real Needle- Placebo Needle|"Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial.
real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
71534|NCT01948193|B1|Baseline|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
71535|NCT01948193|P1|Participant Flow|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
71536|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
71537|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
71538|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
71539|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
71540|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
71541|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
71542|NCT01948193|E1|Reported Event|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
71543|NCT01948141|B1|Baseline|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
nintedanib: Given PO
laboratory biomarker analysis: Correlative studies"
71544|NCT01948141|P1|Participant Flow|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
nintedanib: Given PO
laboratory biomarker analysis: Correlative studies"
71545|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
nintedanib: Given PO"
71546|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
nintedanib: Given PO"
71547|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
nintedanib: Given PO"
71548|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
nintedanib: Given PO"
71549|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
nintedanib: Given PO"
71550|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
nintedanib: Given PO"
71551|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
nintedanib: Given PO"
71552|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
nintedanib: Given PO"
71553|NCT01948141|E1|Reported Event|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
nintedanib: Given PO
laboratory biomarker analysis: Correlative studies"
71554|NCT01948076|B3|Baseline|Total|Total of all reporting groups
71555|NCT01948076|B2|Baseline|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
71556|NCT01948076|B1|Baseline|Resident Without GE Vscan|baseline physical exam use
71557|NCT01948076|P2|Participant Flow|Intervention Group|Received training and access to ultrasounds. During assessment performed physical exam first followed by ultrasound exam
71558|NCT01948076|P1|Participant Flow|Control Group|Performed only physical exam with no access to ultrasoun
71559|NCT01948076|O2|Outcome|Intervention Group (Using Ultrasound)|residents with augmentation of physical exam by ultrasound
71560|NCT01948076|O1|Outcome|Intervention Group (Using Physical Exam Only)|Baseline physical exam prior to using the ultrasound
71561|NCT01948076|O2|Outcome|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
71567|NCT01948063|B1|Baseline|Placebo|Patients will receive a placebo pill or a liquid placebo. The liquid placebo is 50 milliliters of Ensure (a dietary supplement). Placebo will be given every 12 hours for 7 days or until hospital discharge.
71568|NCT01948063|P2|Participant Flow|Ubiquinol|Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
71569|NCT01948063|P1|Participant Flow|Placebo|Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
71570|NCT01948063|O2|Outcome|Ubiquinol|Patients will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
71571|NCT01948063|O1|Outcome|Placebo|Patients will receive a placebo pill or a liquid placebo. The liquid placebo is 50 milliliters of Ensure (a dietary supplement). Placebo will be given every 12 hours for 7 days or until hospital discharge.
71572|NCT01948063|E2|Reported Event|Placebo|Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
71573|NCT01948063|E1|Reported Event|Ubiquinol|Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
71574|NCT01948050|B3|Baseline|Total|Total of all reporting groups
71575|NCT01948050|B2|Baseline|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
71576|NCT01948050|B1|Baseline|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
71577|NCT01948050|P2|Participant Flow|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
71578|NCT01948050|P1|Participant Flow|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
71628|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71579|NCT01948050|O2|Outcome|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
71580|NCT01948050|O1|Outcome|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
71581|NCT01948050|E2|Reported Event|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
71582|NCT01948050|E1|Reported Event|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
71583|NCT01947946|B4|Baseline|Total|Total of all reporting groups
71584|NCT01947946|B3|Baseline|Placebo|A (Dummy) injection
71585|NCT01947946|B2|Baseline|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
71586|NCT01947946|B1|Baseline|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
71587|NCT01947946|P3|Participant Flow|Placebo|A (Dummy) injection
71588|NCT01947946|P2|Participant Flow|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
71589|NCT01947946|P1|Participant Flow|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
71590|NCT01947946|O3|Outcome|Placebo|A (Dummy) injection
71591|NCT01947946|O2|Outcome|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
71592|NCT01947946|O1|Outcome|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
71593|NCT01947946|E3|Reported Event|Placebo|A (Dummy) injection
71594|NCT01947946|E2|Reported Event|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
71595|NCT01947946|E1|Reported Event|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
71596|NCT01947907|B5|Baseline|Total|Total of all reporting groups
71597|NCT01947907|B4|Baseline|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)
Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
71598|NCT01947907|B3|Baseline|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71599|NCT01947907|B2|Baseline|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71600|NCT01947907|B1|Baseline|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71601|NCT01947907|P4|Participant Flow|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)
Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
71602|NCT01947907|P3|Participant Flow|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71603|NCT01947907|P2|Participant Flow|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71608|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71609|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71610|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71611|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71612|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71613|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71614|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71615|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71616|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71617|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71618|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)
Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
71619|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71620|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71621|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71622|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)
Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
71623|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71624|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71625|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71626|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)
Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
71764|NCT01946438|B5|Baseline|Total|Total of all reporting groups
71629|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71630|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)
Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
71631|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71632|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71633|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71634|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)
Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
71635|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71636|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71637|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71638|NCT01947907|E4|Reported Event|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)
Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
71639|NCT01947907|E3|Reported Event|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71640|NCT01947907|E2|Reported Event|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71641|NCT01947907|E1|Reported Event|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001
ACP-001: Once weekly subcutaneous injection"
71642|NCT01947855|B4|Baseline|Total|Total of all reporting groups
71643|NCT01947855|B3|Baseline|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
71644|NCT01947855|B2|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
71645|NCT01947855|B1|Baseline|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
71646|NCT01947855|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
71647|NCT01947855|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
71648|NCT01947855|P1|Participant Flow|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
71649|NCT01947855|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
71650|NCT01947855|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
71651|NCT01947855|O1|Outcome|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
71652|NCT01947855|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
71653|NCT01947855|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
71654|NCT01947855|E1|Reported Event|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
71655|NCT01947582|B1|Baseline|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
71656|NCT01947582|P1|Participant Flow|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
71657|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
71658|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
71659|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
71660|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
71661|NCT01947582|E1|Reported Event|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
71662|NCT01947517|B3|Baseline|Total|Total of all reporting groups
71663|NCT01947517|B2|Baseline|Superflex Group|"Randomized to receive Group B punctal plugs
Superflex Punctal Occluder"
71664|NCT01947517|B1|Baseline|Parasol Group|"Randomized to receive Brand A punctal plugs
Parasol Punctal Occluder"
71665|NCT01947517|P2|Participant Flow|Superflex Group|"Randomized to receive Group B punctal plugs
Superflex Punctal Occluder"
71666|NCT01947517|P1|Participant Flow|Parasol Group|"Randomized to receive Brand A punctal plugs
Parasol Punctal Occluder"
71667|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs
Superflex Punctal Occluder"
71668|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs
Parasol Punctal Occluder"
71669|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs
Superflex Punctal Occluder"
71670|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs
Parasol Punctal Occluder"
71671|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs
Superflex Punctal Occluder"
71672|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs
Parasol Punctal Occluder"
71673|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs
Superflex Punctal Occluder"
71674|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs
Parasol Punctal Occluder"
71675|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs
Superflex Punctal Occluder"
71676|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs
Parasol Punctal Occluder"
71677|NCT01947517|E2|Reported Event|Superflex Group|"Randomized to receive Group B punctal plugs
Superflex Punctal Occluder"
71678|NCT01947517|E1|Reported Event|Parasol Group|"Randomized to receive Brand A punctal plugs
Parasol Punctal Occluder"
71679|NCT01947491|B5|Baseline|Total|Total of all reporting groups
71680|NCT01947491|B4|Baseline|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days
Vehicle Lotion"
71681|NCT01947491|B3|Baseline|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days
Comp01 Lotion"
71683|NCT01947491|B1|Baseline|DFD01 Spray|"DFD01 Spray twice daily for 28 days
DFD01 Spray"
71684|NCT01947491|P4|Participant Flow|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days
Vehicle Lotion"
71685|NCT01947491|P3|Participant Flow|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days
Comp01 Lotion"
71686|NCT01947491|P2|Participant Flow|Vehicle Spray|"Vehicle Spray twice daily for 28 days
Vehicle Spray"
71687|NCT01947491|P1|Participant Flow|DFD01 Spray|"DFD01 Spray twice daily for 28 days
DFD01 Spray"
71688|NCT01947491|O4|Outcome|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days
Vehicle Lotion"
71689|NCT01947491|O3|Outcome|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days
Comp01 Lotion"
71690|NCT01947491|O2|Outcome|Vehicle Spray|"Vehicle Spray twice daily for 28 days
Vehicle Spray"
71691|NCT01947491|O1|Outcome|DFD01 Spray|"DFD01 Spray twice daily for 28 days
DFD01 Spray"
71692|NCT01947491|E4|Reported Event|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days
Vehicle Lotion"
71693|NCT01947491|E3|Reported Event|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days
Comp01 Lotion"
71694|NCT01947491|E2|Reported Event|Vehicle Spray|"Vehicle Spray twice daily for 28 days
Vehicle Spray"
71695|NCT01947491|E1|Reported Event|DFD01 Spray|"DFD01 Spray twice daily for 28 days
DFD01 Spray"
71696|NCT01947335|B3|Baseline|Total|Total of all reporting groups
71697|NCT01947335|B2|Baseline|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention
IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
71698|NCT01947335|B1|Baseline|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
71699|NCT01947335|P2|Participant Flow|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention
IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
71700|NCT01947335|P1|Participant Flow|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
71701|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention
IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
71702|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
71703|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention
IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
71704|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
71705|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention
IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
71706|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
71707|NCT01947335|E2|Reported Event|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention
IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
71708|NCT01947335|E1|Reported Event|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
71709|NCT01947153|B1|Baseline|All Subjects|All subjects treated with 5 mg linagliptin / 1000 mg metformin as fixed dose combination or as free dose combination.
71710|NCT01947153|P2|Participant Flow|Free Combination First, Then Fixed Dose Combination|Free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet first; then 5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets
71711|NCT01947153|P1|Participant Flow|Fixed Dose Combination First, Then Free Combination|5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets first; then free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet
71712|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin
Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
71713|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin
Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
71714|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin
Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
71715|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin
Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
71716|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin
Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
71717|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin
Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
71718|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin
Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
71719|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin
Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
71720|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin
Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
71721|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin
Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
71722|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin
Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
71723|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin
Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
71724|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin
Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
71725|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin
Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
71726|NCT01947153|E2|Reported Event|Free Combination|"Linagliptin and Metformin
Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
71727|NCT01947153|E1|Reported Event|Fixed Dose Combination|"Linagliptin/Metformin
Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
71728|NCT01947127|B3|Baseline|Total|Total of all reporting groups
71729|NCT01947127|B2|Baseline|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
71730|NCT01947127|B1|Baseline|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
71731|NCT01947127|P2|Participant Flow|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
71732|NCT01947127|P1|Participant Flow|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
71733|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
71734|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
71735|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
71736|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
71737|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
71738|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
71739|NCT01947127|E2|Reported Event|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
71740|NCT01947127|E1|Reported Event|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
71741|NCT01946542|B3|Baseline|Total|Total of all reporting groups
71742|NCT01946542|B2|Baseline|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.
Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
71743|NCT01946542|B1|Baseline|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.
Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
71744|NCT01946542|P2|Participant Flow|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.
Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
71745|NCT01946542|P1|Participant Flow|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.
Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
71746|NCT01946542|O2|Outcome|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.
Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
71747|NCT01946542|O1|Outcome|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.
Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
71748|NCT01946542|O2|Outcome|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.
Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
71749|NCT01946542|O1|Outcome|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.
Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
71750|NCT01946542|E2|Reported Event|Beet Juice Concentrate|
71753|NCT01946529|B3|Baseline|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
71754|NCT01946529|B2|Baseline|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
71755|NCT01946529|B1|Baseline|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
71756|NCT01946529|P3|Participant Flow|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
71757|NCT01946529|P2|Participant Flow|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
71758|NCT01946529|P1|Participant Flow|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
71759|NCT01946529|O1|Outcome|Group B (High Risk) - ESFT|Participants received vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. Patients with measurable disease were eligible to receive irinotecan, temozolomide, and temsirolimus. Additionally, all patients were eligible to receive a maintenance therapy at the end of treatment including bevacizumab and sorafenib. Depending on the size and location of the participant's tumor, they had surgery alone, radiation alone, or surgery followed by radiation.
71760|NCT01946529|E4|Reported Event|Group B (High Risk) - Total|"All Group B High Risk participants with ESFT or DSRCT.
Participants received vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. Patients with measurable disease were eligible to receive irinotecan, temozolomide, and temsirolimus. Additionally, all patients were eligible to receive a maintenance therapy at the end of treatment including bevacizumab and sorafenib. Depending on the size and location of the participant's tumor, they had surgery alone, radiation alone, or surgery followed by radiation."
71761|NCT01946529|E3|Reported Event|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
71762|NCT01946529|E2|Reported Event|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
71763|NCT01946529|E1|Reported Event|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
71765|NCT01946438|B4|Baseline|Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71766|NCT01946438|B3|Baseline|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71767|NCT01946438|B2|Baseline|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
71768|NCT01946438|B1|Baseline|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71769|NCT01946438|P4|Participant Flow|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71770|NCT01946438|P3|Participant Flow|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71771|NCT01946438|P2|Participant Flow|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
71772|NCT01946438|P1|Participant Flow|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71773|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71774|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71775|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
71776|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71777|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71778|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71779|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
71780|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71781|NCT01946438|O4|Outcome|Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71782|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71783|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
71784|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71785|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71786|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71787|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
71788|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Vaccine 2013-2014 formulation
71789|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71790|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71791|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
71792|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71793|NCT01946438|E4|Reported Event|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71794|NCT01946438|E3|Reported Event|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71854|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
71795|NCT01946438|E2|Reported Event|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
71796|NCT01946438|E1|Reported Event|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
71797|NCT01946425|B3|Baseline|Total|Total of all reporting groups
71798|NCT01946425|B2|Baseline|Age 3 to <9 Years Group|Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation)
71799|NCT01946425|B1|Baseline|Age 6 to <36 Months Group|Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation)
71800|NCT01946425|P2|Participant Flow|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
71801|NCT01946425|P1|Participant Flow|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
71802|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
71803|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
71804|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
71805|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
71806|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
71807|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
71808|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
71809|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
71810|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
71811|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
71812|NCT01946425|E2|Reported Event|Age 3 Years to <9 Years Group|Participants age 3 years to < 9 years of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation)
71813|NCT01946425|E1|Reported Event|Age 6 Months to <36 Months Group|Participants 6 months to < 36 months of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation)
71814|NCT01946412|B1|Baseline|Ivacaftor|Participants received ivacaftor 50 mg or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered q12h for participants aged 2 to < 6 years and weighing <14 kg, ivacaftor 75 mg q12h for participants aged 2 to <6 years and weighing >= 14 kg and ivacaftor 150 mg q12h for participants >=6 years.
71815|NCT01946412|P1|Participant Flow|Ivacaftor|Participants received ivacaftor 50 milligram (mg) or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered every 12 hours (q12h) for participants aged 2 to less than (<) 6 years and weighing <14 kilograms (kg), ivacaftor 75 mg q12h for participants aged 2 to <6 years and weighing greater than or equal to (>=) 14 kg and ivacaftor 150 mg q12h for participants >=6 years.
71816|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71817|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71818|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71819|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71820|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71821|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71822|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71855|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
71891|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71823|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71824|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71825|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71826|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71827|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71828|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71829|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71830|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71831|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71832|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71872|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
71833|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71834|NCT01946412|E2|Reported Event|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71835|NCT01946412|E1|Reported Event|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
71836|NCT01946243|B1|Baseline|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
71837|NCT01946243|P1|Participant Flow|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
71838|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
71839|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
71840|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
71841|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
71842|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
71843|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
71844|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
71845|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
71846|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
71847|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
71848|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
71849|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
71850|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
71851|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
71852|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
71853|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
71856|NCT01946243|E1|Reported Event|Florbetapir PET Scans|No subjects received florbetapir in this study. This study consisted of re-reads of scans previously acquired in other clinical studies (A07/A16 and A17).
71857|NCT01946178|B1|Baseline|All Treated Patients|All patients who underwent treatment with the device
71858|NCT01946178|P1|Participant Flow|All Treated Patients|All patients who underwent treatment with the device
71859|NCT01946178|O2|Outcome|Entire Validation Cohort|The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for all 36 patients in the Validation Cohort.
71860|NCT01946178|O1|Outcome|Entire Development Cohort|The Development Cohort includes the first 37 patients treated in the study sequence. Treatments in the Development Cohort were used for dose-ranging purposes to develop the most appropriate HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for all 37 patients in the Development Cohort.
71861|NCT01946178|O2|Outcome|Validation Cohort With NPVs Observed|"The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 35 out of 36 patients (97.2%) in the Validation Cohort with NPVs observed following treatment.
Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment."
71862|NCT01946178|O1|Outcome|Development Cohort With NPVs Observed|"The Development Cohort includes the first 37 patients treated in the study sequence. Treatments in the Development Cohort were used for dose-ranging purposes to develop the most appropriate HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 33 out of 37 patients (89.2%) in the Development Cohort with NPVs observed following treatment.
Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment."
71863|NCT01946178|O1|Outcome|All Treated Patients|All patients who underwent treatment with the device
71864|NCT01946178|E1|Reported Event|All Treated Patients|All patients who underwent treatment with the device
71865|NCT01946126|B3|Baseline|Total|Total of all reporting groups
71866|NCT01946126|B2|Baseline|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
71867|NCT01946126|B1|Baseline|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
71868|NCT01946126|P2|Participant Flow|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
71869|NCT01946126|P1|Participant Flow|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
71870|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
71871|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
71873|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
71874|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
71875|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
71876|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
71877|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
71878|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
71879|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
71880|NCT01946126|E2|Reported Event|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
71881|NCT01946126|E1|Reported Event|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
71882|NCT01945970|B1|Baseline|Study Subjects|All six treatment orders combined
71883|NCT01945970|P6|Participant Flow|Placebo - Black Tea - Positive Control|"Subjects treated in the order Placebo - wash out - Black tea - wash out- Positive control.
Treatments each lasted one week and were separated by a one week washout."
71884|NCT01945970|P5|Participant Flow|Placebo- Positive Control - Black Tea|"Subjects treated in the order Placebo - wash out - Positive control - wash out- Black tea.
Treatments each lasted one week and were separated by a one week washout."
71885|NCT01945970|P4|Participant Flow|Positive Control - Placebo - Black Tea|"Subjects treated in the order Positive control - wash out - Placebo - wash out - Black tea.
Treatments each lasted one week and were separated by a one week washout."
71886|NCT01945970|P3|Participant Flow|Positive Control - Black Tea - Placebo|"Subjects treated in the order Positive control - wash out - Black tea - wash out - Placebo.
Treatments each lasted one week and were separated by a one week washout."
71887|NCT01945970|P2|Participant Flow|Black Tea - Placebo - Positive Control|"Subjects treated in the order Black tea - wash out- Placebo control - wash out - Positive control.
Treatments each lasted one week and were separated by a one week washout."
71888|NCT01945970|P1|Participant Flow|Black Tea - Positive Control - Placebo|"Subjects treated in the order Black tea - wash out- Positive control - wash out - Placebo.
Treatments each lasted one week and were separated by a one week washout."
71889|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71890|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
71892|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
71893|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71894|NCT01945970|O1|Outcome|Postive Control Beverage|Participant when they received the positive control
71895|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71896|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
71897|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71898|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
71899|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71900|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
71901|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71902|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
71903|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71904|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
71905|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71906|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
71907|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71908|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
71909|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71910|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
71911|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71912|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
71913|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71914|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
71915|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71916|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
71917|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71918|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back Tea
71919|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
71920|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back Tea
71921|NCT01945970|E3|Reported Event|Placebo|Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract
71922|NCT01945970|E2|Reported Event|Positive Control|Spray dried aqueous extract of a batch of tea extract that has shown to improve Flow Mediated Dilation previously
71926|NCT01945944|B1|Baseline|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline)"
71927|NCT01945944|P2|Participant Flow|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%)"
71928|NCT01945944|P1|Participant Flow|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline)"
71929|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
71930|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
71931|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
71932|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
71933|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
71934|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
71935|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
71936|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
71937|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
71938|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
71939|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
71940|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
71941|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
71942|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
71943|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
71944|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
71945|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%)"
71946|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline)"
71947|NCT01945944|E2|Reported Event|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Hypertonic saline (3%)"
94729|NCT01813721|O2|Outcome|Hematologist|
71948|NCT01945944|E1|Reported Event|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Placebo (0.9% saline)"
71949|NCT01945294|B4|Baseline|Total|Total of all reporting groups
71950|NCT01945294|B3|Baseline|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
71951|NCT01945294|B2|Baseline|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
71952|NCT01945294|B1|Baseline|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
71953|NCT01945294|P4|Participant Flow|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
71954|NCT01945294|P3|Participant Flow|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
71955|NCT01945294|P2|Participant Flow|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
71956|NCT01945294|P1|Participant Flow|All Treated Participants|All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA]) or allocation to Arm 3 (participants with detectable HCV RNA).
71957|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
71958|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
72029|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
71959|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
71960|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
71961|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
71962|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
71963|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
71964|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
71965|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
71966|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
71967|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
71968|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
71969|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
71970|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
71971|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
71972|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
71973|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
71974|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
71975|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
71976|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
71977|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
71978|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
72068|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
71979|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
71980|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
71981|NCT01945294|E3|Reported Event|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
71982|NCT01945294|E2|Reported Event|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
71983|NCT01945294|E1|Reported Event|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
71984|NCT01945242|B3|Baseline|Total|Total of all reporting groups
71985|NCT01945242|B2|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
71986|NCT01945242|B1|Baseline|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
71987|NCT01945242|P2|Participant Flow|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
71988|NCT01945242|P1|Participant Flow|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
71989|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
71990|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
71991|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
71992|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
72017|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
71993|NCT01945242|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
71994|NCT01945242|O1|Outcome|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
71995|NCT01945242|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
71996|NCT01945242|O1|Outcome|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
71997|NCT01945242|E2|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
71998|NCT01945242|E1|Reported Event|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
71999|NCT01945138|B3|Baseline|Total|Total of all reporting groups
72000|NCT01945138|B2|Baseline|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72001|NCT01945138|B1|Baseline|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72002|NCT01945138|P2|Participant Flow|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72003|NCT01945138|P1|Participant Flow|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72004|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72005|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72006|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72007|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72008|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72009|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72010|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72011|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72012|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72013|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72014|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72015|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72016|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
94730|NCT01813721|O1|Outcome|Medical Oncologist|
72018|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72019|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72020|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72021|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72022|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72023|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72024|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72025|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72026|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72027|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72028|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72674|NCT01941498|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
72030|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72031|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72032|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72033|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72034|NCT01945138|E2|Reported Event|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
72035|NCT01945138|E1|Reported Event|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
72036|NCT01945112|B1|Baseline|Paper Tape|Paper was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
72037|NCT01945112|P2|Participant Flow|Paper Tape on Left and No Tape on Right Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
72038|NCT01945112|P1|Participant Flow|Paper Tape on Right and No Tape on Left Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
72039|NCT01945112|O1|Outcome|Paper Tape|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
72040|NCT01945112|E2|Reported Event|Tape on Left Foot and No Tape on Right Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
72041|NCT01945112|E1|Reported Event|Paper Tape on RIght Foot and No Tape on Left Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
72042|NCT01945086|B4|Baseline|Total|Total of all reporting groups
72043|NCT01945086|B3|Baseline|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
94731|NCT01813721|O4|Outcome|France|
72044|NCT01945086|B2|Baseline|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72045|NCT01945086|B1|Baseline|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72046|NCT01945086|P3|Participant Flow|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72047|NCT01945086|P2|Participant Flow|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72048|NCT01945086|P1|Participant Flow|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72049|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72050|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72051|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72052|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72053|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72054|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72055|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72056|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72057|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72058|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72059|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72060|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72061|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72062|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72063|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72064|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72065|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72066|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72067|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72069|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72070|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72071|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72072|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72073|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72074|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72075|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72076|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72077|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72078|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72079|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72080|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72081|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72082|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72083|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72084|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72085|NCT01945086|E3|Reported Event|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
72086|NCT01945086|E2|Reported Event|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
72087|NCT01945086|E1|Reported Event|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
72088|NCT01945034|B4|Baseline|Total|Total of all reporting groups
72089|NCT01945034|B3|Baseline|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72090|NCT01945034|B2|Baseline|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72143|NCT01945021|B1|Baseline|Crizotinib|Single arm trial whereby all consented, enrolled, eligible patients receive crizotinib
72144|NCT01945021|P1|Participant Flow|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
72091|NCT01945034|B1|Baseline|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72092|NCT01945034|P3|Participant Flow|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72093|NCT01945034|P2|Participant Flow|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72094|NCT01945034|P1|Participant Flow|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72095|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72096|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72097|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72098|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72099|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72100|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72101|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72102|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72103|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72104|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72105|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72106|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72107|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72108|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72109|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72110|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72111|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72112|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72113|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72114|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72115|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72116|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72145|NCT01945021|O1|Outcome|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
72117|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72118|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72119|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72120|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72121|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72122|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72123|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72124|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72125|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72126|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72127|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72128|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72129|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72130|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72131|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72132|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72133|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72134|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72135|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72136|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72137|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72138|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72139|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72140|NCT01945034|E3|Reported Event|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
72141|NCT01945034|E2|Reported Event|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72142|NCT01945034|E1|Reported Event|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
72146|NCT01945021|O1|Outcome|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
72147|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) included all enrolled patients who receive at least one dose of study medication. (n=127).
72148|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
72149|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
72150|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
72151|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
72152|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
72153|NCT01945021|O1|Outcome|Participants With Objective Response by Independent Review|Defined as all patients in the safety analysis population who have an adequate baseline tumor assessment and an objective response determined by Independent Review (n=88).
72154|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
72155|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
72156|NCT01945021|E1|Reported Event|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
72157|NCT01944969|B1|Baseline|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
72158|NCT01944969|P1|Participant Flow|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
72159|NCT01944969|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
72160|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
72161|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
72206|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
72162|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
72163|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1,2, or 3 mg/day, once daily dose, tablets, orally"
72164|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
72165|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
72166|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
72167|NCT01944969|E1|Reported Event|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
72168|NCT01944878|B3|Baseline|Total|Total of all reporting groups
72169|NCT01944878|B2|Baseline|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
72170|NCT01944878|B1|Baseline|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
72171|NCT01944878|P2|Participant Flow|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
72172|NCT01944878|P1|Participant Flow|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
72173|NCT01944878|O2|Outcome|No PUD in Lchronic Hepatitis|
72174|NCT01944878|O1|Outcome|PUD in Chronic Hepatitis|
72175|NCT01944878|O2|Outcome|No PUD in Liver Cirrhosis|Patients without PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
72176|NCT01944878|O1|Outcome|PUD in Liver Cirrhosis|Patients with PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
72177|NCT01944878|E2|Reported Event|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
72178|NCT01944878|E1|Reported Event|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
72179|NCT01944774|B4|Baseline|Total|Total of all reporting groups
72180|NCT01944774|B3|Baseline|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
72181|NCT01944774|B2|Baseline|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
72182|NCT01944774|B1|Baseline|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
72183|NCT01944774|P3|Participant Flow|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
72184|NCT01944774|P2|Participant Flow|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
72185|NCT01944774|P1|Participant Flow|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
72186|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
72187|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
72188|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
72189|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
72190|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
72191|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
72192|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
72193|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
72194|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
72195|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
72196|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
72197|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
72198|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
72199|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
72200|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
72201|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
72202|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
72203|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
72204|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
72205|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
72675|NCT01941498|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
72207|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
72208|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
72209|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
72210|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
72211|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
72212|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
72213|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
72214|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
72215|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
72216|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
72217|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
72218|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
72219|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
72220|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
72221|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
72222|NCT01944774|E3|Reported Event|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
72223|NCT01944774|E2|Reported Event|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
72224|NCT01944774|E1|Reported Event|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
72225|NCT01944670|B1|Baseline|Internal Joint Stabilizer Group|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)
Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
72226|NCT01944670|P1|Participant Flow|Internal Joint Stabilizer Group|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)
Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
72227|NCT01944670|O1|Outcome|Participants Who Completed the Study|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)
Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
72228|NCT01944670|O1|Outcome|Participants Who Completed the Study|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)
Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
72420|NCT01943292|E1|Reported Event|Defactinib 200 mg Bid|200 mg po bid defactinib
72229|NCT01944670|E1|Reported Event|Participants Who Completed the Study|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)
Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
72230|NCT01944631|B3|Baseline|Total|Total of all reporting groups
72231|NCT01944631|B2|Baseline|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72232|NCT01944631|B1|Baseline|Placebo|Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72233|NCT01944631|P2|Participant Flow|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72234|NCT01944631|P1|Participant Flow|Placebo|Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72235|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72236|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72237|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72238|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72239|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72240|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72241|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72242|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72243|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72244|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72245|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72665|NCT01941498|O2|Outcome|FS200 Laser|Femtosecond FS200 laser used during LASIK surgery for corneal ablation
72246|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72247|NCT01944631|E2|Reported Event|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72248|NCT01944631|E1|Reported Event|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
72249|NCT01944345|B1|Baseline|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
72250|NCT01944345|P1|Participant Flow|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
72251|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
72252|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
72253|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
72254|NCT01944345|E1|Reported Event|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
72255|NCT01944319|B3|Baseline|Total|Total of all reporting groups
72256|NCT01944319|B2|Baseline|Study Group|"Patients in Study group will accept meropenem therapy based on PPK and PD parameter.
Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter"
72257|NCT01944319|B1|Baseline|Control Group|Meropenem therapy with regimen routinely decided by attending physician
72258|NCT01944319|P2|Participant Flow|Study Group|"Patients in Study group will accept meropenem therapy based on PPK and PD parameter.
Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter"
72259|NCT01944319|P1|Participant Flow|Control Group|Meropenem therapy with regimen routinely decided by attending physician
72260|NCT01944319|O2|Outcome|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
72261|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
72262|NCT01944319|O2|Outcome|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
72263|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
72264|NCT01944319|O2|Outcome|Study Group|The participants in stusy group will accept meropenem therapy based on a PPK and PD model.
72265|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
72266|NCT01944319|E2|Reported Event|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
72267|NCT01944319|E1|Reported Event|Control Group|The participants in control group will accept routine meropenem therapy.
72268|NCT01944059|B1|Baseline|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.
Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.
Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.
Placebo (l-alanine): Theramine like placebo comparator"
72269|NCT01944059|P1|Participant Flow|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.
Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.
Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.
Placebo (l-alanine): Theramine like placebo comparator"
72270|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.
Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.
Placebo (l-alanine): Theramine like placebo comparator"
72271|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.
Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.
Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
72272|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.
Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.
Placebo (l-alanine): Theramine like placebo comparator"
72273|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.
Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.
Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
72274|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.
Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.
Placebo (l-alanine): Theramine like placebo comparator"
72275|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.
Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.
Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
72666|NCT01941498|O1|Outcome|EX500 Laser|Excimer 500 laser used during LASIK surgery for corneal ablation
72276|NCT01944059|E1|Reported Event|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.
Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.
Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.
Placebo (l-alanine): Theramine like placebo comparator"
72277|NCT01943864|B1|Baseline|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72278|NCT01943864|P1|Participant Flow|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72279|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72280|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72281|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72282|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72283|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72284|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72411|NCT01943292|P1|Participant Flow|Defactinib 200 mg Bid|200 mg bid (twice a day) po (by mouth) defactinib
72412|NCT01943292|O3|Outcome|Defactinib 600 mg Bid|600 mg po bid defactinib
72285|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72286|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72287|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72288|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72289|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72290|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72291|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72292|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72293|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72294|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72295|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72296|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72297|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72298|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72299|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72300|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72301|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72302|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72303|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72413|NCT01943292|O2|Outcome|Defactinib 400 mg Bid|400 mg po bid defactinib
94732|NCT01813721|O3|Outcome|Romania|
72304|NCT01943864|E1|Reported Event|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
72305|NCT01943565|B4|Baseline|Total|Total of all reporting groups
72306|NCT01943565|B3|Baseline|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72307|NCT01943565|B2|Baseline|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72308|NCT01943565|B1|Baseline|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72309|NCT01943565|P3|Participant Flow|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72310|NCT01943565|P2|Participant Flow|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72311|NCT01943565|P1|Participant Flow|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72312|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72313|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72314|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72315|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72316|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72317|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72318|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72353|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
72319|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72320|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72321|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72322|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72323|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72324|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72325|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72326|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72327|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72328|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72329|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72330|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72331|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72414|NCT01943292|O1|Outcome|Defactinib 200 mg Bid|200 mg po bid defactinib
72415|NCT01943292|O3|Outcome|Defactinib 600 mg Bid|600 mg po bid defactinib
72332|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72333|NCT01943565|O3|Outcome|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72334|NCT01943565|O2|Outcome|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72335|NCT01943565|O1|Outcome|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72336|NCT01943565|E3|Reported Event|Hydromorphone 100mcg|"The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72337|NCT01943565|E2|Reported Event|Hydromorphone 50mcg|"The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72338|NCT01943565|E1|Reported Event|Hydromorphone 25mcg|"The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia
Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg
spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)"
72339|NCT01943552|B3|Baseline|Total|Total of all reporting groups
72340|NCT01943552|B2|Baseline|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
72341|NCT01943552|B1|Baseline|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
72342|NCT01943552|P2|Participant Flow|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
72343|NCT01943552|P1|Participant Flow|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
72344|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
72345|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
72346|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
72347|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
72348|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
72349|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
72350|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
72351|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
72352|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
72354|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
72355|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
72356|NCT01943552|E2|Reported Event|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
72357|NCT01943552|E1|Reported Event|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
72358|NCT01943474|B3|Baseline|Total|Total of all reporting groups
72359|NCT01943474|B2|Baseline|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
72360|NCT01943474|B1|Baseline|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72361|NCT01943474|P2|Participant Flow|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
72362|NCT01943474|P1|Participant Flow|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72363|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
72364|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72416|NCT01943292|O2|Outcome|Defactinib 400 mg Bid|400 mg po bid defactinib
72417|NCT01943292|O1|Outcome|Defactinib 200 mg Bid|200 mg po bid defactinib
94733|NCT01813721|O2|Outcome|Greece|
72365|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
72366|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72367|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
72368|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72369|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72370|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
72371|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72372|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
72373|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72374|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
72375|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72664|NCT01941498|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72376|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
72377|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72378|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
72379|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72380|NCT01943474|E2|Reported Event|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
72381|NCT01943474|E1|Reported Event|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
72382|NCT01943435|B4|Baseline|Total|Total of all reporting groups
72383|NCT01943435|B3|Baseline|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:
Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations
Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
72384|NCT01943435|B2|Baseline|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.
Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
72385|NCT01943435|B1|Baseline|Usual Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following: NSAIDs, Adjunctive analgesics, antidepressants.
Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient.
Lumbar epidural injection: these will be prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications.
NSAIDs; adjunctive analgesics; adjunctive anti-depressants: Physician will administer these medications based upon the individual needs of each patient.
Lumbar epidural injection: The attending physician may refer s"
72386|NCT01943435|P3|Participant Flow|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:
Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations
Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
72387|NCT01943435|P2|Participant Flow|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.
Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
72388|NCT01943435|P1|Participant Flow|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:
NSAIDs, Adjunctive analgesics, antidepressants,
Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
72438|NCT01942785|P1|Participant Flow|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72472|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72389|NCT01943435|O3|Outcome|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:
Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.
Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
72390|NCT01943435|O2|Outcome|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.
Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
72391|NCT01943435|O1|Outcome|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:
NSAIDs, Adjunctive analgesics, antidepressants,
Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
72392|NCT01943435|O3|Outcome|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:
Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.
Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
72418|NCT01943292|E3|Reported Event|Defactinib 600 mg Bid|600 mg po bid defactinib
72419|NCT01943292|E2|Reported Event|Defactinib 400 mg Bid|400 mg po bid defactinib
94734|NCT01813721|O1|Outcome|Poland|
72393|NCT01943435|O2|Outcome|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.
Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
72394|NCT01943435|O1|Outcome|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:
NSAIDs, Adjunctive analgesics, antidepressants,
Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
72395|NCT01943435|O3|Outcome|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:
Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.
Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
72396|NCT01943435|O2|Outcome|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.
Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
72397|NCT01943435|O1|Outcome|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:
NSAIDs, Adjunctive analgesics, antidepressants,
Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
72398|NCT01943435|E3|Reported Event|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:
Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations
Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
72439|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use"
72646|NCT01941498|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72399|NCT01943435|E2|Reported Event|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.
Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
72400|NCT01943435|E1|Reported Event|Usual Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following: NSAIDs, Adjunctive analgesics, antidepressants.
Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
72401|NCT01943344|B1|Baseline|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™
VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
72402|NCT01943344|P1|Participant Flow|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™
VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
72403|NCT01943344|O1|Outcome|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™
VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
72404|NCT01943344|E1|Reported Event|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™
VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
72405|NCT01943292|B4|Baseline|Total|Total of all reporting groups
72406|NCT01943292|B3|Baseline|Defactinib 600 mg Bid|600 mg po bid defactinib
72407|NCT01943292|B2|Baseline|Defactinib 400 mg Bid|400 mg po bid defactinib
72408|NCT01943292|B1|Baseline|Defactinib 200 mg Bid|200 mg po bid defactinib
72409|NCT01943292|P3|Participant Flow|Defactinib 600 mg Bid|600 mg bid po defactinib
72410|NCT01943292|P2|Participant Flow|Defactinib 400 mg Bid|400 mg bid po defactinib
94735|NCT01813721|O1|Outcome|Primary Analysis Set|
72421|NCT01943110|B1|Baseline|Saline Injection With ID Adapters|"Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:
Upper deltoid with the side-load ID adapter
Upper deltoid with the AD ID adapter
Suprascapular (behind the shoulder) with the side-load ID adapter
Suprascapular with the AD ID adapter
Forearm with the side-load ID adapter
Forearm with the AD ID adapter
ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.
ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin."
72422|NCT01943110|P1|Participant Flow|Saline Injection With ID Adapters|"Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:
Upper deltoid with the side-load ID adapter
Upper deltoid with the AD ID adapter
Suprascapular (behind the shoulder) with the side-load ID adapter
Suprascapular with the AD ID adapter
Forearm with the side-load ID adapter
Forearm with the AD ID adapter
ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.
ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin."
72423|NCT01943110|O2|Outcome|SLA ID Adapter|Injections given with the side-load ID adapter
72424|NCT01943110|O1|Outcome|AD ID Adapter|Injections given with the autodisable ID adapter
72425|NCT01943110|O6|Outcome|SLA Suprascapular|Injections given with the side-load ID adapter in the suprascapular region
72426|NCT01943110|O5|Outcome|SLA Forearm|Injections given with the side-load ID adapter in the forearm
72427|NCT01943110|O4|Outcome|SLA Deltoid|Injections given with the side-load ID adapter in the deltoid region
72428|NCT01943110|O3|Outcome|ADID Suprascapular|Injections given with the autodisable ID adapter in the suprascapular region
72429|NCT01943110|O2|Outcome|ADID Forearm|Injections given with the autodisable ID adapter in the forearm
72430|NCT01943110|O1|Outcome|ADID Deltoid|Injections given with the autodisable ID adapter in the deltoid region
72431|NCT01943110|E6|Reported Event|SLA Suprascapular|Injections given with the side-load ID adapter in the suprascapular region
72432|NCT01943110|E5|Reported Event|SLA Forearm|Injections given with the side-load ID adapter in the forearm region
72433|NCT01943110|E4|Reported Event|SLA Deltoid|Injections given with the side-load ID adapter in the deltoid region
72434|NCT01943110|E3|Reported Event|ADID Suprascapular|Injections given with the autodisable ID adapter in the suprascapular region
72435|NCT01943110|E2|Reported Event|ADID Forearm|Injections given with the autodisable ID adapter in the forearm region
72436|NCT01943110|E1|Reported Event|ADID Deltoid|Injections given with the autodisable ID adapter in the deltoid region
72437|NCT01942785|B1|Baseline|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72647|NCT01941498|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
72440|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use"
72441|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)
Brexpiprazole:2-3 mg/day, once daily dose, tablets, for oral use"
72442|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72443|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72444|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72445|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72446|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72447|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72448|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72449|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72450|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72451|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72452|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72453|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72454|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72455|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
94736|NCT01813721|O2|Outcome|General Hospital|
72456|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72457|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72458|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72459|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72460|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72461|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72462|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72463|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72464|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
72465|NCT01942785|E1|Reported Event|Brexpiprazole|Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use
72466|NCT01942733|B1|Baseline|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72467|NCT01942733|P1|Participant Flow|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72468|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72469|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72470|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72471|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72473|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72474|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72475|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72476|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72477|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72478|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72479|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72480|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72481|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72482|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72483|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72484|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72485|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72486|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72487|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72488|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72489|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72490|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72491|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72492|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72493|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
72494|NCT01942733|E1|Reported Event|Brexpiprazole|The all-patients-treated set (APTS) comprises all patients who took at least one dose of brexpiprazole.
72495|NCT01942720|B1|Baseline|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
72496|NCT01942720|P1|Participant Flow|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
72497|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
72498|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
72499|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
72500|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
72501|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
72502|NCT01942720|E1|Reported Event|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
72503|NCT01942707|B3|Baseline|Total|Total of all reporting groups
72504|NCT01942707|B2|Baseline|Keeping Scarpa`s Fascia|"Abdominoplasty in anchor-line keeping Scarpa`s Fascia.
Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
72505|NCT01942707|B1|Baseline|No Keeping Scarpa`s Fascia|"Abdominoplasty in anchor-line without keeping Scarpa`s Fascia.
Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
72506|NCT01942707|P2|Participant Flow|Anchor-line Abdominoplasty With Scarpa`s Fascia|Anchor-line abdominoplasty. In this group the Scarpa`s Fascia will be preserved.
72507|NCT01942707|P1|Participant Flow|Anchor-line Abdominoplasty Without Scarpa`s Fascia|Anchor-line abdominoplasty. The Scarpa`s Fascia will be removed in this group.
72508|NCT01942707|O2|Outcome|With Scarpa`s Fascia|"Abdominoplasty in anchor-line keeping Scarpa`s Fascia.
Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
72509|NCT01942707|O1|Outcome|Without Scarpa`s Fascia|"Abdominoplasty in anchor-line without keeping Scarpa`s Fascia.
Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
72510|NCT01942707|O2|Outcome|With Scarpa`s Fascia|"Abdominoplasty in anchor-line keeping Scarpa`s Fascia.
Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
72648|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
72649|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72511|NCT01942707|O1|Outcome|Without Scarpa`s Fascia|"Abdominoplasty in anchor-line without keeping Scarpa`s Fascia.
Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
72512|NCT01942707|O2|Outcome|With Scarpa`s Fascia|"Abdominoplasty in anchor-line keeping Scarpa`s Fascia.
Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
72513|NCT01942707|O1|Outcome|Without Scarpa`s Fascia|"Abdominoplasty in anchor-line without keeping Scarpa`s Fascia.
Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups"
72514|NCT01942707|E2|Reported Event|Anchor-line Abdominoplasty With Scarpa`s Fascia|Anchor-line abdominoplasty where the Scarpa´s Fascia will be preserved.
72515|NCT01942707|E1|Reported Event|Anchor-line Abdominoplasty Without Scarpa`s Fascia|Anchor-line Abdominoplasty where the Scarpa`s Fascia will be removed.
72516|NCT01942161|B4|Baseline|Total|Total of all reporting groups
72517|NCT01942161|B3|Baseline|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
72518|NCT01942161|B2|Baseline|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.
Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
72519|NCT01942161|B1|Baseline|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
72520|NCT01942161|P3|Participant Flow|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
72521|NCT01942161|P2|Participant Flow|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.
Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
72522|NCT01942161|P1|Participant Flow|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
72540|NCT01942161|E1|Reported Event|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
72523|NCT01942161|O3|Outcome|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
72524|NCT01942161|O2|Outcome|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.
Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
72525|NCT01942161|O1|Outcome|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
72526|NCT01942161|O3|Outcome|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
72527|NCT01942161|O2|Outcome|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.
Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
72528|NCT01942161|O1|Outcome|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
72529|NCT01942161|O3|Outcome|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
72530|NCT01942161|O2|Outcome|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.
Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
72531|NCT01942161|O1|Outcome|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
72650|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72651|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
72652|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72532|NCT01942161|O3|Outcome|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
72533|NCT01942161|O2|Outcome|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.
Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
72534|NCT01942161|O1|Outcome|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
72535|NCT01942161|O3|Outcome|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
72536|NCT01942161|O2|Outcome|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.
Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
72537|NCT01942161|O1|Outcome|Low (2 mg/Day)|"Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks"
72538|NCT01942161|E3|Reported Event|High (24 - 30 mg/Day)|"Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg"
72539|NCT01942161|E2|Reported Event|Mid (6 - 12 mg/Day)|"Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.
Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg"
72541|NCT01942148|B1|Baseline|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
72542|NCT01942148|P1|Participant Flow|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
72543|NCT01942148|O1|Outcome|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
72544|NCT01942148|O1|Outcome|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
72545|NCT01942148|O1|Outcome|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
72546|NCT01942148|E1|Reported Event|Aripiprazole|Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study.
72547|NCT01942135|B3|Baseline|Total|Total of all reporting groups
72548|NCT01942135|B2|Baseline|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72549|NCT01942135|B1|Baseline|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72550|NCT01942135|P2|Participant Flow|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72551|NCT01942135|P1|Participant Flow|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72653|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72552|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72553|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72554|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72555|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72556|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72557|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72702|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
72703|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72704|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72558|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72559|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72560|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72561|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72562|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72563|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72564|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72654|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
72655|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72656|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72565|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72566|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72567|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72568|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72569|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72570|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72571|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72572|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72573|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72574|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72575|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72576|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72577|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72657|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
72658|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72578|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72579|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72580|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72581|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72582|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72583|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72584|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72585|NCT01942135|E2|Reported Event|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72586|NCT01942135|E1|Reported Event|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
72587|NCT01941940|B1|Baseline|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72588|NCT01941940|P1|Participant Flow|Tocilizumab|Tocilizumab at a fixed dose of 162 milligrams (mg) was administered as subcutaneous (SC) injection alone or along with methotrexate and/or other non-biological Disease-Modifying Antirheumatic Drugs (DMARDs) irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72589|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72590|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72591|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72823|NCT01940497|B3|Baseline|Total|Total of all reporting groups
72592|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72593|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72594|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72595|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72596|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72597|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72598|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72705|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
72599|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72600|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72601|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72602|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72603|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72604|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72605|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72606|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72607|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72659|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72608|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72609|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72610|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72611|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72612|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72613|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72614|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72615|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72616|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72617|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72618|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72619|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72620|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72621|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72622|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72623|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72660|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
72624|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72625|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72626|NCT01941940|E1|Reported Event|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 638 days).
72627|NCT01941615|B1|Baseline|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
72628|NCT01941615|P1|Participant Flow|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
72629|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
72706|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
72707|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72708|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72630|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
72631|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
72632|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
72633|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
72634|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
72635|NCT01941615|E1|Reported Event|Deleobuvir + Faldaprevir + Microgynon|"In the run-in period starting between Day -56 and Day -28, all subjects were to take 1 Microgynon® tablet (combined oral contraceptive ethinylestradiol / levonorgestrel) once daily for 21 to 49 days (depending on the menstrual cycle) until Day -8.
In the last 7 days of the run-in period (Day -7 to Day -1), no treatment was given in order to induce withdrawal bleeding. The next day was to be Day 1 of the study. Subjects who were using oral contraceptives before the study started the run-in period after the usual tablet-free interval of 7 days.
Subjects who were using hormonal contraceptive vaginal rings before the study started the run-in-period after the usual hormone-free interval of 7 days."
72636|NCT01941498|B1|Baseline|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72637|NCT01941498|P1|Participant Flow|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72638|NCT01941498|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72639|NCT01941498|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
72640|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72641|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
72642|NCT01941498|O2|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72643|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
72644|NCT01941498|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72645|NCT01941498|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
72676|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72677|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72678|NCT01941498|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
72679|NCT01941498|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72680|NCT01941498|E2|Reported Event|Screen Failure|Prior to treatment
72681|NCT01941498|E1|Reported Event|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
72682|NCT01941485|B1|Baseline|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72683|NCT01941485|P1|Participant Flow|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72684|NCT01941485|O1|Outcome|Angles|WaveLight Refractive Suite
72685|NCT01941485|O1|Outcome|AC Depth|WaveLight Refractive Suite
72686|NCT01941485|O1|Outcome|AC Volume|WaveLight Refractive Suite
72687|NCT01941485|O1|Outcome|Q-Value|WaveLight Refractive Suite
72688|NCT01941485|O1|Outcome|FS200 Laser|Femtosecond FS200 laser used during LASIK surgery for corneal flap creation
72689|NCT01941485|O5|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
72690|NCT01941485|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72691|NCT01941485|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
72692|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72693|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
72694|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
72695|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72696|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72697|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
72698|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
72699|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72700|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72701|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
72709|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
72710|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
72711|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72712|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72713|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
72714|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
72715|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72716|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72717|NCT01941485|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
72718|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
72719|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72720|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
72721|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72722|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
72723|NCT01941485|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
72724|NCT01941485|O5|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
72725|NCT01941485|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72726|NCT01941485|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
72727|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72728|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
72729|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72730|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72731|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
72732|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72733|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
72734|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72735|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
72736|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
72737|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
72738|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
72739|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
72740|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
72741|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
72742|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
72743|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72744|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72745|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72746|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72747|NCT01941485|E1|Reported Event|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
72748|NCT01941472|B1|Baseline|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
72749|NCT01941472|P1|Participant Flow|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
72750|NCT01941472|O1|Outcome|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
72751|NCT01941472|E1|Reported Event|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
72752|NCT01941186|B3|Baseline|Total|Total of all reporting groups
72753|NCT01941186|B2|Baseline|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
72754|NCT01941186|B1|Baseline|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
72755|NCT01941186|P2|Participant Flow|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
72924|NCT01940146|P4|Participant Flow|SPARC1310 III|SPARC1310 III was administered as two sprays/nostril QD
72925|NCT01940146|P3|Participant Flow|SPARC1310 II|SPARC1310 II was administered as two sprays/nostril QD
72756|NCT01941186|P1|Participant Flow|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
72757|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
72758|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
72759|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
72760|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
72761|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
72762|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
72763|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
72764|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
72765|NCT01941186|O12|Outcome|Routine Care: Strongly Agree|"Percentage of parents who answered strongly agree to questions during pre and post intervention"
72766|NCT01941186|O11|Outcome|Routine Care: Agree|"Percentage of parents who answered agree to questions during pre and post intervention"
72767|NCT01941186|O10|Outcome|Routine Care: Somewhat Agree|"Percentage of parents who answered somewhat agree to questions during pre and post intervention."
72768|NCT01941186|O9|Outcome|Routine Care: Somewhat Disagree|"Percentage of parents who answered somewhat disagree to questions during pre and post intervention"
72769|NCT01941186|O8|Outcome|Routine Care: Disagree|"Percentage of parents who answered disagree to questions during pre and post intervention"
74109|NCT01937130|P3|Participant Flow|IDN-6556 50 mg|"Dosed twice daily
IDN-6556"
72770|NCT01941186|O7|Outcome|Routine Care: Strongly Disagree|"Percentage of parents who answered strongly disagree to questions during pre and post intervention"
72771|NCT01941186|O6|Outcome|Patient Decision Aid: Strongly Agree|"Percentage of parents who answered Strongly Agree to questions during pre and post intervention"
72772|NCT01941186|O5|Outcome|Patient Decision Aid: Agree|"Percentage of parents who answered agree to questions during pre and post intervention"
72773|NCT01941186|O4|Outcome|Patient Decision Aid: Somewhat Agree|"Percentage of parents who answered somewhat agree to questions during pre and post intervention"
72774|NCT01941186|O3|Outcome|Patient Decision Aid: Somewhat Disagree|"Percentage of parents who answered somewhat disagree to questions during pre and post"
72775|NCT01941186|O2|Outcome|Patient Decision Aid: Disagree|"Percentage of parents who answered disagree to questions during pre and post intervention"
72776|NCT01941186|O1|Outcome|Patient Decision Aid: Strongly Disagree|"Percentage of parents who answered strongly disagree to questions during pre and post intervention"
72777|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
72778|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
72779|NCT01941186|E2|Reported Event|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
72780|NCT01941186|E1|Reported Event|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
72781|NCT01940523|B3|Baseline|Total|Total of all reporting groups
72782|NCT01940523|B2|Baseline|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
72926|NCT01940146|P2|Participant Flow|SPARC1310 I|SPARC1310 I was administered as two sprays /nostril QD
72927|NCT01940146|P1|Participant Flow|SPARC Placebo|SPARC Placebo was administered as sprays/nostril QD
72783|NCT01940523|B1|Baseline|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
72784|NCT01940523|P2|Participant Flow|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
72785|NCT01940523|P1|Participant Flow|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. Tourniquet will be released.
Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m)."
72786|NCT01940523|O2|Outcome|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
72787|NCT01940523|O1|Outcome|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
72788|NCT01940523|O2|Outcome|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
72789|NCT01940523|O1|Outcome|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
72790|NCT01940523|E2|Reported Event|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
72791|NCT01940523|E1|Reported Event|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
72792|NCT01940510|B1|Baseline|Whole Study: Alectinib + Rifampin|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally alone on Day 1 (Period 1), with rifampin (600 mg capsules orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
72810|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72793|NCT01940510|P1|Participant Flow|Whole Study: Alectinib + Rifampin|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib (RO5424802) 600 milligram (mg) capsules (four 150 mg capsules) orally alone on Day 1 (Period 1), with rifampin (600 mg capsules [two 300 mg capsules] orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
72794|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72795|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72796|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72797|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72798|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72799|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72800|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72801|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72802|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72803|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
73163|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
72804|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72805|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72806|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72807|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72808|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72809|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72811|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72812|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72813|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72814|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72815|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72816|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72817|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72818|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72819|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72820|NCT01940510|E3|Reported Event|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
72821|NCT01940510|E2|Reported Event|Treatment Period 2: Rifampin|Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 8 through 16.
72822|NCT01940510|E1|Reported Event|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
72824|NCT01940497|B2|Baseline|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72825|NCT01940497|B1|Baseline|Trastuzumab (Vial)|Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72826|NCT01940497|P2|Participant Flow|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72827|NCT01940497|P1|Participant Flow|Trastuzumab (Vial)|Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72828|NCT01940497|O2|Outcome|HCPs: Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). Trastuzumab using SID had to be administered by an HCP or by the participant after appropriate training and under HCP supervision.
72829|NCT01940497|O1|Outcome|HCPs: Trastuzumab (Vial)|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone). Trastuzumab using vial had to be administered by an HCP.
72830|NCT01940497|O1|Outcome|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72831|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72832|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72922|NCT01940146|B2|Baseline|SPARC1310 I|Baseline characteristics: Age
72833|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72834|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72835|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72836|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72837|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72838|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72839|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72840|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72841|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72842|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72843|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72844|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72845|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72846|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72847|NCT01940497|O2|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72848|NCT01940497|O1|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72849|NCT01940497|O2|Outcome|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72850|NCT01940497|O1|Outcome|Trastuzumab (Vial)|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72851|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72852|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72853|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72854|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72855|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72856|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72857|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72858|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72859|NCT01940497|O4|Outcome|Trastuzumab (SID): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72860|NCT01940497|O3|Outcome|Trastuzumab (SID): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72861|NCT01940497|O2|Outcome|Trastuzumab (Vial): Neoadjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72862|NCT01940497|O1|Outcome|Trastuzumab (Vial): Adjuvant|Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72863|NCT01940497|E2|Reported Event|Trastuzumab (SID)|Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72864|NCT01940497|E1|Reported Event|Trastuzumab (Vial)|Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy [consisting of doxorubicin, paclitaxel or docetaxel] and 14 cycles administered alone).
72865|NCT01940484|B1|Baseline|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72866|NCT01940484|P1|Participant Flow|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta (Mircera) as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72867|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72868|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72869|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72870|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72871|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72872|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72873|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72874|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72875|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72876|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72877|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72878|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72879|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72880|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72881|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72882|NCT01940484|E1|Reported Event|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
72883|NCT01940471|B3|Baseline|Total|Total of all reporting groups
72884|NCT01940471|B2|Baseline|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72885|NCT01940471|B1|Baseline|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72886|NCT01940471|P2|Participant Flow|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72887|NCT01940471|P1|Participant Flow|TAF 25 mg|Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72888|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72889|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72890|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72891|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72892|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72893|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72894|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72895|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72896|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72897|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72898|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks per amendment 1 & 2) or 144 weeks (per amendment 3)
72899|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72900|NCT01940471|E2|Reported Event|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72901|NCT01940471|E1|Reported Event|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72902|NCT01940341|B3|Baseline|Total|Total of all reporting groups
72903|NCT01940341|B2|Baseline|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72904|NCT01940341|B1|Baseline|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72905|NCT01940341|P2|Participant Flow|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72906|NCT01940341|P1|Participant Flow|TAF 25 mg|Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72907|NCT01940341|O2|Outcome|TDF + TAF Placebo|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72908|NCT01940341|O1|Outcome|TAF + TDF Placebo|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72909|NCT01940341|O2|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72910|NCT01940341|O1|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72911|NCT01940341|O2|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72912|NCT01940341|O1|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72913|NCT01940341|O2|Outcome|TDF + TAF Placebo|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72914|NCT01940341|O1|Outcome|TAF + TDF Placebo|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72915|NCT01940341|O2|Outcome|TDF + TAF Placebo|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72916|NCT01940341|O1|Outcome|TAF + TDF Placebo|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72917|NCT01940341|E2|Reported Event|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72918|NCT01940341|E1|Reported Event|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
72919|NCT01940146|B5|Baseline|Total|Total of all reporting groups
72920|NCT01940146|B4|Baseline|SPARC1310 III|S0597 high dose: S0597 high dose
72921|NCT01940146|B3|Baseline|SPARC1310 II|S0597 mid dose: S0597 mid dose
72928|NCT01940146|O4|Outcome|S0597 High Dose|S0597 high dose: S0597 high dose
72929|NCT01940146|O3|Outcome|S0597 Mid Dose|S0597 mid dose: S0597 mid dose
72930|NCT01940146|O2|Outcome|S0597 Low Dose|S0597 low dose: S0597 low dose
72931|NCT01940146|O1|Outcome|Placebo|Placebo: Placebo
72932|NCT01940146|E4|Reported Event|SPARC1310 III|SPARC1310 III administration
72933|NCT01940146|E3|Reported Event|SPARC1310 II|SPARC1310 II administration
72934|NCT01940146|E2|Reported Event|SPARC1310 I|SPARC1310 I administration
72935|NCT01940146|E1|Reported Event|SPARC Placebo|SPARC Placebo administration
72936|NCT01940120|B1|Baseline|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72937|NCT01940120|P1|Participant Flow|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72938|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72939|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72940|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72941|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72942|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73164|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73660|NCT01938170|E1|Reported Event|FluMist|"Subjects receiving vaccine at home
FluMist: Subjects receiving Flumist vaccine"
72943|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72944|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72945|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72946|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72947|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72948|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72949|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72950|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72951|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73185|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
72952|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72953|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72954|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72955|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72956|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72957|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72958|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72959|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72960|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72961|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73661|NCT01938079|B3|Baseline|Total|Total of all reporting groups
72962|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72963|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72964|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72965|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72966|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72967|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72968|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72969|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72970|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72971|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72972|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72973|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72974|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72975|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72976|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72977|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72978|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72979|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72980|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73691|NCT01938040|O1|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
72981|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72982|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72983|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72984|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72985|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72986|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72987|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72988|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72989|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72990|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72991|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72992|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72993|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72994|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72995|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72996|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72997|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72998|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
72999|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
74110|NCT01937130|P2|Participant Flow|IDN-6556 25 mg|"Dosed twice daily
IDN-6556"
73000|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73001|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73002|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73003|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73004|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73005|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73006|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73007|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73008|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73009|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73010|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73011|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73012|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73013|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73014|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73015|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73016|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73017|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73018|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
74111|NCT01937130|P1|Participant Flow|IDN-6556 5 mg|"Dosed twice daily
IDN-6556"
73019|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73020|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73021|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73022|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73023|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73024|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73025|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73026|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73027|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73028|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73029|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73030|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73031|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73032|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73033|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73034|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73035|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73036|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73037|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
74112|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily
Placebo"
73038|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73039|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73040|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73041|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73042|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73043|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73044|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73045|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73046|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73047|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73048|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73049|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73050|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73051|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73052|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73053|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73054|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73055|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
73056|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
74113|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily
IDN-6556"
73057|NCT01940120|E1|Reported Event|High Risk Registry Arm|"Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percutaneous mitral valve repair using MitraClip implant: Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve"
73058|NCT01939938|B1|Baseline|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.
Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
73059|NCT01939938|P1|Participant Flow|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.
Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
73060|NCT01939938|O2|Outcome|Residual AHI|AHI residual.
73061|NCT01939938|O1|Outcome|Baseline AHI|AHI at baseline.
73062|NCT01939938|E1|Reported Event|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.
Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
73063|NCT01939548|B4|Baseline|Total|Total of all reporting groups
73064|NCT01939548|B3|Baseline|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73065|NCT01939548|B2|Baseline|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73066|NCT01939548|B1|Baseline|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73067|NCT01939548|P3|Participant Flow|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73186|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73068|NCT01939548|P2|Participant Flow|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73069|NCT01939548|P1|Participant Flow|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73070|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73071|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73072|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73073|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73074|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73075|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73076|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73165|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73166|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
74114|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily
IDN-6556"
73077|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73078|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73079|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73080|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73081|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73082|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73083|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73187|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73188|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73084|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73085|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73086|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73087|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73088|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73089|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73090|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73091|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73092|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73093|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73094|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73095|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73096|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73097|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73098|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73099|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73100|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73101|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73102|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73103|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73104|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73105|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73106|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73107|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73108|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73109|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73110|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73111|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73112|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73113|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73114|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73115|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73116|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73117|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73118|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73119|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73120|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73121|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73122|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73123|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73124|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73125|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73126|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73127|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73128|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73129|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73130|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73131|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73132|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73133|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73134|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73135|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73136|NCT01939548|E3|Reported Event|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73137|NCT01939548|E2|Reported Event|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73138|NCT01939548|E1|Reported Event|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
73139|NCT01939496|B4|Baseline|Total|Total of all reporting groups
73140|NCT01939496|B3|Baseline|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73141|NCT01939496|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73142|NCT01939496|B1|Baseline|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73143|NCT01939496|P3|Participant Flow|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73144|NCT01939496|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73145|NCT01939496|P1|Participant Flow|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73146|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73147|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73148|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73149|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73150|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73151|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73152|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73153|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73154|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73155|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73156|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73157|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73158|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73159|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73160|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73161|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73162|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
74115|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily
IDN-6556"
73167|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73168|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73169|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73170|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73171|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73172|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73173|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73174|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73175|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73176|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73177|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73178|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73179|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73180|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73181|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73182|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73183|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73184|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73189|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73190|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73191|NCT01939496|E3|Reported Event|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
73192|NCT01939496|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
73193|NCT01939496|E1|Reported Event|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
73194|NCT01939314|B3|Baseline|Total|Total of all reporting groups
73195|NCT01939314|B2|Baseline|Normal Saline|Normal Saline delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally
73196|NCT01939314|B1|Baseline|Bupivacaine|Bupivacaine delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally
73197|NCT01939314|P2|Participant Flow|Normal Saline|"normal saline .03 ml to each nare
Placebo: Placebo"
73198|NCT01939314|P1|Participant Flow|Bupivacaine|"Bupivicaine .03ml to each nare
Bupivacaine: intervention"
73199|NCT01939314|O2|Outcome|Normal Saline|"normal saline .03 ml to each nare
Placebo: Placebo"
73200|NCT01939314|O1|Outcome|Bupivacaine|"Bupivicaine .03ml to each nare
Bupivacaine: intervention"
73201|NCT01939314|O2|Outcome|Normal Saline|"normal saline .03 ml to each nare
Placebo: Placebo"
73202|NCT01939314|O1|Outcome|Bupivacaine|"Bupivicaine .03ml to each nare
Bupivacaine: intervention"
73203|NCT01939314|O2|Outcome|Normal Saline|Normal Saline .03ml to each nare
73204|NCT01939314|O1|Outcome|Bupivacaine|Bupivicaine .03ml to each nare
73205|NCT01939314|E2|Reported Event|Normal Saline|"normal saline .03 ml to each nare
Placebo: Placebo"
73206|NCT01939314|E1|Reported Event|Bupivacaine|"Bupivicaine .03ml to each nare
Bupivacaine: intervention"
73207|NCT01939145|B3|Baseline|Total|Total of all reporting groups
73208|NCT01939145|B2|Baseline|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.
Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
73209|NCT01939145|B1|Baseline|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.
Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
74116|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily
Placebo"
73210|NCT01939145|P2|Participant Flow|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.
Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
73211|NCT01939145|P1|Participant Flow|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.
Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
73212|NCT01939145|O2|Outcome|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.
Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
73213|NCT01939145|O1|Outcome|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.
Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
73214|NCT01939145|O2|Outcome|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.
Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
73702|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery"
94737|NCT01813721|O1|Outcome|University Hospital|
73215|NCT01939145|O1|Outcome|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.
Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
73216|NCT01939145|E2|Reported Event|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.
Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
73217|NCT01939145|E1|Reported Event|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.
Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
73218|NCT01939002|B3|Baseline|Total|Total of all reporting groups
73219|NCT01939002|B2|Baseline|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73220|NCT01939002|B1|Baseline|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73221|NCT01939002|P2|Participant Flow|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73222|NCT01939002|P1|Participant Flow|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73685|NCT01938040|P1|Participant Flow|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
73223|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73224|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73225|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73226|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73227|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73228|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73229|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
73230|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
73231|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73232|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73233|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73234|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73235|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73395|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73236|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73237|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73238|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73239|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73240|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73241|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73242|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73703|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery"
73243|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73244|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73245|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73246|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73247|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73248|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73249|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
74117|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily
IDN-6556"
73250|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73251|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73252|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73253|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73254|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73255|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
74085|NCT01937260|B1|Baseline|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
73256|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73257|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73258|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73259|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73260|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73261|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73262|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73263|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73686|NCT01938040|O2|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
73264|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73265|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73266|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73267|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73268|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73269|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73270|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73271|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73272|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73273|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73274|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73275|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73276|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73299|NCT01938430|B10|Baseline|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73687|NCT01938040|O1|Outcome|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
73277|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73278|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73279|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
73280|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
73281|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73282|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
94738|NCT01813721|O2|Outcome|> 10 Years|
73283|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
73284|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:
current FLS management regimen as determined by the clinician; or
500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently."
73285|NCT01939002|E2|Reported Event|BIIB017 Plus Naproxen|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
73286|NCT01939002|E1|Reported Event|BIIB017 Plus Current FLS Therapy|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
73287|NCT01938989|B1|Baseline|Overall|Blue light filter clip-on glasses and clear clip-on glasses worn over habitual correction in a crossover assignment.
73288|NCT01938989|P2|Participant Flow|Blue Light Filter, Then Clear|Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
73289|NCT01938989|P1|Participant Flow|Clear, Then Blue Light Filter|Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
73290|NCT01938989|O2|Outcome|Clear|Clear clip-on glasses worn over habitual correction
73291|NCT01938989|O1|Outcome|Blue Light Filter|Blue light filter clip-on glasses worn over habitual correction
73292|NCT01938989|E2|Reported Event|Clear|Clear clip-on glasses worn over habitual correction
73293|NCT01938989|E1|Reported Event|Blue Light Filter|Blue light filter clip-on glasses worn over habitual correction
73294|NCT01938430|B15|Baseline|Total|Total of all reporting groups
73295|NCT01938430|B14|Baseline|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73296|NCT01938430|B13|Baseline|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73297|NCT01938430|B12|Baseline|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73298|NCT01938430|B11|Baseline|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73345|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73300|NCT01938430|B9|Baseline|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73301|NCT01938430|B8|Baseline|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73302|NCT01938430|B7|Baseline|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73303|NCT01938430|B6|Baseline|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73304|NCT01938430|B5|Baseline|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73305|NCT01938430|B4|Baseline|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73306|NCT01938430|B3|Baseline|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73307|NCT01938430|B2|Baseline|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73308|NCT01938430|B1|Baseline|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73309|NCT01938430|P14|Participant Flow|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
94739|NCT01813721|O1|Outcome|≤ 10 Years|
73310|NCT01938430|P13|Participant Flow|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73311|NCT01938430|P12|Participant Flow|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73312|NCT01938430|P11|Participant Flow|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73313|NCT01938430|P10|Participant Flow|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73314|NCT01938430|P9|Participant Flow|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73315|NCT01938430|P8|Participant Flow|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73316|NCT01938430|P7|Participant Flow|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73317|NCT01938430|P6|Participant Flow|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73318|NCT01938430|P5|Participant Flow|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis"
73319|NCT01938430|P4|Participant Flow|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73320|NCT01938430|P3|Participant Flow|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73321|NCT01938430|P2|Participant Flow|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73346|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73322|NCT01938430|P1|Participant Flow|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
73323|NCT01938430|O11|Outcome|Cohort B: Baseline CPT Class C (24 wk)|Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
73324|NCT01938430|O10|Outcome|Cohort B: Baseline CPT Class C (12 wk)|Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
73325|NCT01938430|O9|Outcome|Cohort B: Baseline CPT Class B (24 wk)|Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
73326|NCT01938430|O8|Outcome|Cohort B: Baseline CPT Class B (12 wk)|Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
73327|NCT01938430|O7|Outcome|Cohort B: Baseline CPT Class A (24 wk)|Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
73328|NCT01938430|O6|Outcome|Cohort B: Baseline CPT Class A (12 wk)|Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
73329|NCT01938430|O5|Outcome|Cohort A: Baseline CPT Class C (24 wk)|Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
73330|NCT01938430|O4|Outcome|Cohort A: Baseline CPT Class C (12 wk)|Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
73331|NCT01938430|O3|Outcome|Cohort A: Baseline CPT Class B (24 wk)|Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
73332|NCT01938430|O2|Outcome|Cohort A: Baseline CPT Class B (12 wk)|Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
73333|NCT01938430|O1|Outcome|Cohort A: Baseline CPT Class A (24 wk)|Includes participants in Cohort A (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
73334|NCT01938430|O10|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73335|NCT01938430|O9|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73336|NCT01938430|O8|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73337|NCT01938430|O7|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73338|NCT01938430|O6|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73339|NCT01938430|O5|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73340|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73341|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73342|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73343|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73344|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73688|NCT01938040|O2|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
74118|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily
IDN-6556"
73347|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73348|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73349|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73350|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73351|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73352|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73353|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73354|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73355|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73378|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73356|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73357|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73358|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73359|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73360|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73361|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73362|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73363|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73364|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73365|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73366|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73367|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73368|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73369|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73393|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73370|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73371|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73372|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73373|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73374|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73375|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73376|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73377|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73704|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery"
94740|NCT01813721|O1|Outcome|Medical Oncologist|
73379|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73380|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73381|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73382|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73383|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73384|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73385|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73386|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73387|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73388|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73389|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73390|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73391|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73392|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73394|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73396|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73397|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73398|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73399|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73400|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73401|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73402|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73403|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73705|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery"
73404|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73405|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73406|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73407|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73408|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73409|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73410|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73411|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73412|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73413|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73414|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73415|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73416|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73417|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73418|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73689|NCT01938040|O1|Outcome|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
73419|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73420|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73421|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73422|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73423|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73424|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73425|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73426|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
74086|NCT01937260|P2|Participant Flow|Cohort 2|Brodalumab 140 mg SC (Day 1)
73427|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73428|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73429|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73430|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73431|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73432|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73433|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73434|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73435|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73436|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73437|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73438|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73439|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73440|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73441|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73442|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
74119|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily
IDN-6556"
73443|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73444|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73445|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73446|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73447|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73448|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73449|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73450|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73451|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73452|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73453|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73454|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73455|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73456|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73457|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73458|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73459|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73460|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73461|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73462|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73463|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73464|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73465|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73512|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73466|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73467|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73468|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73469|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73470|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73471|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73472|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73473|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73474|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73475|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73476|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73477|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73478|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73479|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73480|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73481|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73482|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73483|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73484|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73485|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73486|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73487|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73488|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73513|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73489|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73490|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73491|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73492|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73493|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73494|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73495|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73706|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery"
94741|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
73496|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73497|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73498|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73499|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73500|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73501|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73502|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73503|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73504|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73505|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73506|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73507|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73508|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73509|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73510|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73511|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73514|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73515|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73516|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73517|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73518|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73519|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73520|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73568|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73521|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73522|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73523|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73524|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73525|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73526|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73527|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73528|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73529|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73530|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73531|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73532|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73533|NCT01938430|O1|Outcome|All LDV/SOF+RBV|All participants in the analysis are presented in a single group, regardless of randomization group assignment.
73534|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73535|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73536|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73537|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73538|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73539|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73540|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73541|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73542|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73543|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73544|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
76980|NCT01922271|E1|Reported Event|NVA237|ALL patients on NVA237 for Period 1 & Period 2
73545|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73546|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73547|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73548|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73549|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73550|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73551|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73552|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73553|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73554|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73555|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73556|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73557|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73558|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73559|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73560|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73561|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73562|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73563|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73564|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73565|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73566|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73567|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73701|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery"
73569|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73570|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73571|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73572|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73573|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73574|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73575|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73576|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73577|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73578|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73579|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73580|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73581|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73582|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73583|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73584|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73585|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73586|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73587|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73588|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73589|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73590|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73591|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73592|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73593|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73594|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73595|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73596|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73597|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73598|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73599|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73600|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73601|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73602|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73603|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73604|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73605|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73606|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73607|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73608|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73609|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73659|NCT01938170|O1|Outcome|FluMist|"Subjects receiving vaccine at home
FluMist: Subjects receiving Flumist vaccine"
73610|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73611|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73612|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73613|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73614|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73615|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73789|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73616|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73617|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73618|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73619|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73620|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73621|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73622|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73623|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73624|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
73625|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73626|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73627|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73628|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73629|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73630|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73631|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73632|NCT01938430|E14|Reported Event|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
73633|NCT01938430|E13|Reported Event|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
73690|NCT01938040|O2|Outcome|Ibuprofen|800 mg in 100mL of normal saline over 5 minutes
73634|NCT01938430|E12|Reported Event|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73635|NCT01938430|E11|Reported Event|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73636|NCT01938430|E10|Reported Event|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73637|NCT01938430|E9|Reported Event|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73638|NCT01938430|E8|Reported Event|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
94742|NCT01813721|O1|Outcome|Primary Analysis Set|
73639|NCT01938430|E7|Reported Event|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
73640|NCT01938430|E6|Reported Event|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
73641|NCT01938430|E5|Reported Event|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
73642|NCT01938430|E4|Reported Event|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
73643|NCT01938430|E3|Reported Event|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
73644|NCT01938430|E2|Reported Event|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
73645|NCT01938430|E1|Reported Event|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
73646|NCT01938391|B1|Baseline|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
73647|NCT01938391|P1|Participant Flow|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
73648|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
73649|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
73650|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
73651|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
73652|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
73653|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
73654|NCT01938391|O1|Outcome|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
73655|NCT01938391|E1|Reported Event|Stealth 360°® OAS|"Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)"
73656|NCT01938170|B1|Baseline|FluMist|"Subjects receiving vaccine at home
FluMist: Subjects receiving Flumist vaccine"
73657|NCT01938170|P1|Participant Flow|FluMist|"Subjects receiving vaccine at home
FluMist: Subjects receiving Flumist vaccine"
73658|NCT01938170|O1|Outcome|FluMist|"Subjects receiving vaccine at home
FluMist: Subjects receiving Flumist vaccine"
73662|NCT01938079|B2|Baseline|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.
Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.
Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
73663|NCT01938079|B1|Baseline|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.
Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
73664|NCT01938079|P2|Participant Flow|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.
Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.
Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
73665|NCT01938079|P1|Participant Flow|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.
Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
73666|NCT01938079|O2|Outcome|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.
Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.
Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
73667|NCT01938079|O1|Outcome|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.
Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
73668|NCT01938079|E2|Reported Event|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.
Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.
Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
73669|NCT01938079|E1|Reported Event|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.
Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
73670|NCT01938066|B3|Baseline|Total|Total of all reporting groups
73671|NCT01938066|B2|Baseline|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.
negative pressure therapy"
73672|NCT01938066|B1|Baseline|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.
Procellera: bioelectric wound dressing
negative pressure therapy"
73673|NCT01938066|P2|Participant Flow|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.
negative pressure therapy"
73674|NCT01938066|P1|Participant Flow|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.
Procellera: bioelectric wound dressing
negative pressure therapy"
73675|NCT01938066|O2|Outcome|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.
negative pressure therapy"
73676|NCT01938066|O1|Outcome|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.
Procellera: bioelectric wound dressing
negative pressure therapy"
73677|NCT01938066|O2|Outcome|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.
negative pressure therapy"
73678|NCT01938066|O1|Outcome|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.
Procellera: bioelectric wound dressing
negative pressure therapy"
73679|NCT01938066|E2|Reported Event|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.
negative pressure therapy"
73680|NCT01938066|E1|Reported Event|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.
Procellera: bioelectric wound dressing
negative pressure therapy"
73681|NCT01938040|B3|Baseline|Total|Total of all reporting groups
73682|NCT01938040|B2|Baseline|Placebo|"100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery"
73683|NCT01938040|B1|Baseline|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery"
73684|NCT01938040|P2|Participant Flow|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
74120|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily
Placebo"
73692|NCT01938040|O2|Outcome|Sugar Water|"100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery"
73693|NCT01938040|O1|Outcome|Ibuprofen|"800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery"
73694|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery"
73695|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery"
73696|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery"
73697|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery"
73698|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery"
73699|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery"
73700|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery"
74087|NCT01937260|P1|Participant Flow|Cohort 1|Midazolam (MDZ) 2mg Oral (Day 1 and Day 9) Brodalumab 210 mg SC (Day 2)
73707|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery"
73708|NCT01938040|E2|Reported Event|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
73709|NCT01938040|E1|Reported Event|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
73710|NCT01937975|B4|Baseline|Total|Total of all reporting groups
73711|NCT01937975|B3|Baseline|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73712|NCT01937975|B2|Baseline|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73713|NCT01937975|B1|Baseline|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73714|NCT01937975|P3|Participant Flow|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73715|NCT01937975|P2|Participant Flow|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73716|NCT01937975|P1|Participant Flow|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73717|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. One participant was excluded due to an ill-defined terminal phase.
73718|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73719|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73720|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73721|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73722|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73723|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. One participant was excluded due to an ill-defined terminal phase.
73724|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73778|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73725|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73726|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73727|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73728|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73729|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73730|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73731|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73732|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
74034|NCT01937364|P2|Participant Flow|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
73733|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73734|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73735|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73736|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73737|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73738|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days
73739|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73740|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73741|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73742|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73743|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73744|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days
73745|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73746|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73747|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73748|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
74066|NCT01937312|E3|Reported Event|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
73749|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73750|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73751|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73752|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73753|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73754|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73755|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73756|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73757|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73758|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
73759|NCT01937975|E3|Reported Event|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73760|NCT01937975|E2|Reported Event|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73761|NCT01937975|E1|Reported Event|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
73762|NCT01937871|B4|Baseline|Total|Total of all reporting groups
73763|NCT01937871|B3|Baseline|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73764|NCT01937871|B2|Baseline|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73765|NCT01937871|B1|Baseline|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73766|NCT01937871|P3|Participant Flow|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
73767|NCT01937871|P2|Participant Flow|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73768|NCT01937871|P1|Participant Flow|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73769|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73770|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73771|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73772|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73773|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
73774|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73775|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73776|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
73777|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73779|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73780|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73781|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73782|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73783|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73784|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73785|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73786|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73787|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
73788|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
79421|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
73790|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73791|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73792|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73793|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
73794|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73795|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73796|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73797|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73798|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73799|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73800|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73801|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73802|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73803|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73804|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73805|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73806|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73807|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73808|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73809|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73810|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
74121|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily
IDN-6556"
73811|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73812|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73813|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73814|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73815|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
73816|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73817|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73818|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
73819|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73820|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
74035|NCT01937364|P1|Participant Flow|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
73821|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73822|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73823|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73824|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73825|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73826|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73827|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73828|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73829|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73830|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73831|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73832|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73833|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73834|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73835|NCT01937871|E3|Reported Event|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
73836|NCT01937871|E2|Reported Event|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.
Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
73837|NCT01937871|E1|Reported Event|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
73838|NCT01937715|B6|Baseline|Total|Total of all reporting groups
73839|NCT01937715|B5|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73840|NCT01937715|B4|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73841|NCT01937715|B3|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
74122|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily
IDN-6556"
73842|NCT01937715|B2|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73843|NCT01937715|B1|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73844|NCT01937715|P5|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73845|NCT01937715|P4|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73846|NCT01937715|P3|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73847|NCT01937715|P2|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73848|NCT01937715|P1|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
94743|NCT01813721|O1|Outcome|Primary Analysis Set|
73849|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73850|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73851|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73852|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73853|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73854|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73855|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73856|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73857|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73858|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73859|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73860|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73861|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73862|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73863|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
74067|NCT01937312|E2|Reported Event|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
73864|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73865|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73866|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73867|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73868|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73869|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73870|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
79422|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
73871|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73872|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73873|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73874|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73875|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73876|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73877|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73878|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73879|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73880|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73881|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73882|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73883|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73884|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73885|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
74014|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
73886|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73887|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73888|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73889|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73890|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73891|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73892|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73893|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73894|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73895|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73896|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73897|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73898|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73899|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73900|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73901|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73902|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73903|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73904|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73905|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73906|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73907|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
74015|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo"
73908|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73909|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73910|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73911|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73912|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73913|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73914|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73915|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73916|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73917|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73918|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73919|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73920|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73921|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73922|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73923|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73924|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73925|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73926|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73927|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73928|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73929|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
74016|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
73930|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73931|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73932|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73933|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73934|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73935|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73936|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73937|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73938|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73939|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73940|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73941|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73942|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73943|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73944|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73945|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73946|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73947|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73948|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73949|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73950|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73951|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
74017|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
74068|NCT01937312|E1|Reported Event|Pre-Treatment|Prostaglandin analogue, 1 drop in each eye at bedtime for a 4-week run-in period
73952|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73953|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73954|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73955|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73956|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73957|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73958|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73959|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73960|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73961|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73962|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73963|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73964|NCT01937715|E5|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73965|NCT01937715|E4|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73966|NCT01937715|E3|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73967|NCT01937715|E2|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
73968|NCT01937715|E1|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
73969|NCT01937598|B1|Baseline|All Study Participants|All study participants (cross-over design) received all interventions.
73970|NCT01937598|P2|Participant Flow|Placebo, Than Sitagliptin|Participants first received Placebo tablet before mixed meal test, after washout they then received Sitagliptin before the mixed meal test.
73971|NCT01937598|P1|Participant Flow|Sitagliptin, Then Placebo|Participants first received Sitagliptin tablet before mixed meal test, after washout they then received Placebo before the mixed meal test.
73972|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
74018|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74019|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
73973|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73974|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
74036|NCT01937364|O2|Outcome|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
74037|NCT01937364|O1|Outcome|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
74038|NCT01937364|O2|Outcome|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
74039|NCT01937364|O1|Outcome|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
73975|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73976|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73977|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73978|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73979|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73980|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
74020|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74021|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
74022|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
73981|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73982|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73983|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73984|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73985|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73986|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73987|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73988|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
74023|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo"
74024|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74025|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo"
73989|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73990|NCT01937598|E2|Reported Event|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets
Placebo
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73991|NCT01937598|E1|Reported Event|Sitagliptin|"Substance: Sitagliptin phosphate 1H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet
Sitagliptin
Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
73992|NCT01937520|B3|Baseline|Total|Total of all reporting groups
73993|NCT01937520|B2|Baseline|Sham/Placebo|"no acupuncture will be done on this group of subjects. Since they are under general anesthesia they will not realize they are acting as control group
no acupuncture: placebo"
73994|NCT01937520|B1|Baseline|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
73995|NCT01937520|P2|Participant Flow|Sham|"no acupuncture will be done on this group of subjects but since they will be under general anesthesia they will not be aware that they are the control group
no acupuncture: placebo"
73996|NCT01937520|P1|Participant Flow|Acupuncture|"acupuncture will be administered after anesthesia induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
73997|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
73998|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
73999|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
74000|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74001|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
74002|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74003|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
74004|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74005|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
74006|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74007|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
74008|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74009|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo"
74010|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74011|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
74012|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74013|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
74069|NCT01937299|B3|Baseline|Total|Total of all reporting groups
74026|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74027|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.
no acupuncture: placebo"
74028|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74029|NCT01937520|E2|Reported Event|Sham/Placebo|"no acupuncture will be done on this group of subjects
no acupuncture: placebo"
74030|NCT01937520|E1|Reported Event|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
acupuncture: One half of subjects will receive a standardized acupuncture regiment"
74031|NCT01937364|B3|Baseline|Total|Total of all reporting groups
74032|NCT01937364|B2|Baseline|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours
74033|NCT01937364|B1|Baseline|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours
74040|NCT01937364|O2|Outcome|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
74041|NCT01937364|O1|Outcome|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
74042|NCT01937364|E2|Reported Event|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
74043|NCT01937364|E1|Reported Event|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
74044|NCT01937351|B3|Baseline|Total|Total of all reporting groups
74045|NCT01937351|B2|Baseline|Roll-In Cohort|The Roll-In Cohort consists of either the 1st subject or 1st and 2nd subjects treated at each site prior to enrollment of subjects into the Primary Cohort. Roll-Ins were designed to provide the Investigator an opportunity to gain experience with the Pantheris System (Catheter and Optical Coherence Tomography-assisted orientation) for learning curve purposes. Certain sites were exempt from enrolling in the Roll-In Cohort.
74046|NCT01937351|B1|Baseline|Primary Cohort|"The Primary Cohort consisted of either the 1st subject enrolled after the Roll-In cohort or the 1st subject enrolled if the site did not utilize Roll-In subjects.
The Primary Cohort was analyzed as two separate sub-cohorts: Intention to Treat and Per Protocol. The Intention to Treat Cohort includes all subjects that were enrolled. The Per Protocol Cohort includes subjects who were enrolled, and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the Intention to Treat Cohort.
The Primary Per Protocol Cohort was the cohort used to determine if the primary endpoints of the VISION Study were met."
74047|NCT01937351|P2|Participant Flow|Roll-in Group|Atherectomy with Pantheris System
74048|NCT01937351|P1|Participant Flow|Primary Cohort|Atherectomy with Pantheris System
74049|NCT01937351|O1|Outcome|Per Protocol Cohort|Atherectomy with Pantheris System
74050|NCT01937351|O1|Outcome|Per Protocol Cohort|Atherectomy with Pantheris System
74051|NCT01937351|O1|Outcome|Per Protocol Cohort|Atherectomy with Pantheris System
74052|NCT01937351|E1|Reported Event|Primary Cohort|Pantheris System
74053|NCT01937312|B3|Baseline|Total|Total of all reporting groups
74054|NCT01937312|B2|Baseline|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74055|NCT01937312|B1|Baseline|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74056|NCT01937312|P2|Participant Flow|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74057|NCT01937312|P1|Participant Flow|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74058|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74059|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74060|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74061|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74062|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74063|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74064|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74065|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
74070|NCT01937299|B2|Baseline|Vehicle|1 drop instilled 3 times a day in each eye for 6 weeks in conjunction with travoprost ophthalmic solution 0.004%
74071|NCT01937299|B1|Baseline|SIMBRINZA|1 drop instilled 3 times a day in each eye for 6 weeks as adjunctive therapy to travoprost ophthalmic solution 0.004%
74072|NCT01937299|P2|Participant Flow|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
74073|NCT01937299|P1|Participant Flow|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
74074|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
74075|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
74076|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
74077|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
74078|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
74079|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
74080|NCT01937299|E3|Reported Event|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period
74081|NCT01937299|E2|Reported Event|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period
74082|NCT01937299|E1|Reported Event|Pre-Treatment|Travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 4-week run-in period
74083|NCT01937260|B3|Baseline|Total|Total of all reporting groups
74088|NCT01937260|O1|Outcome|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
74089|NCT01937260|O1|Outcome|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9)Brodalumab 210mg SC (Day 2)
74090|NCT01937260|O1|Outcome|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
74091|NCT01937260|E2|Reported Event|Cohort 2|Brodalumab 140mg SC (Day1)
74092|NCT01937260|E1|Reported Event|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
74093|NCT01937195|B1|Baseline|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
74094|NCT01937195|P1|Participant Flow|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
74095|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
74096|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
74097|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
74098|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
74099|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
74100|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
74101|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
74102|NCT01937195|E1|Reported Event|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
74103|NCT01937130|B5|Baseline|Total|Total of all reporting groups
74104|NCT01937130|B4|Baseline|Placebo|"Dosed twice daily
Placebo"
74105|NCT01937130|B3|Baseline|IDN-6556 50 mg|"Dosed twice daily
IDN-6556"
74134|NCT01937130|E3|Reported Event|IDN-6556 50 mg|"Dosed twice daily
IDN-6556"
74135|NCT01937130|E2|Reported Event|IDN-6556 25 mg|"Dosed twice daily
IDN-6556"
74136|NCT01937130|E1|Reported Event|IDN-6556 5 mg|"Dosed twice daily
IDN-6556"
74137|NCT01937026|B1|Baseline|Baricitinib|"4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.
1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2."
74138|NCT01937026|P1|Participant Flow|Baricitinib|"4 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.
1000 mg probenecid tablet administered orally, twice daily (BID), on Days 3 through 7 in Period 2."
74139|NCT01937026|O2|Outcome|Baricitinib + Probenecid|"4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.
1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2."
74140|NCT01937026|O1|Outcome|Baricitinib|4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
74141|NCT01937026|O2|Outcome|Baricitinib + Probenecid|"4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.
1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2."
74142|NCT01937026|O1|Outcome|Baricitinib|4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
74143|NCT01937026|E3|Reported Event|Baricitinib + Probenecid|"4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.
1000 mg probenecid tablet administered orally, BID, on Days 5 through 7 in Period 2.
Adverse events are reported from postdose on Day 5 up to Day 18."
74144|NCT01937026|E2|Reported Event|Probenecid|"1000 mg probenecid tablet administered orally, BID, on Days 3 through 4 in Period 2.
Adverse events are reported from postdose on Day 3 through predose on Day 5."
74145|NCT01937026|E1|Reported Event|Baricitinib|"4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
Adverse events are reported from baseline through predose on Day 3."
74146|NCT01936896|B1|Baseline|Alpha-1 Anti-trypsin (AAT)|Plasma derived (Alpha 1-Antitrypsin) AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
74147|NCT01936896|P1|Participant Flow|Alpha-1 Anti-trypsin (AAT)|Plasma derived Alpha 1-Antitrypsin (AAT) 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
74148|NCT01936896|O1|Outcome|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
74149|NCT01936896|O1|Outcome|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
94744|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
74150|NCT01936896|E1|Reported Event|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
74151|NCT01936870|B1|Baseline|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74152|NCT01936870|P1|Participant Flow|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74153|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74154|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74155|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74156|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74157|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74158|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74159|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74160|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74161|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74162|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74163|NCT01936870|E1|Reported Event|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
74164|NCT01936844|B3|Baseline|Total|Total of all reporting groups
74165|NCT01936844|B2|Baseline|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.
Placebo: Placebo twice daily for days 1, 2, and 3
Placebo: Placebo daily for days 4-14"
74166|NCT01936844|B1|Baseline|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14
Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3
Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
74167|NCT01936844|P2|Participant Flow|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.
Placebo: Placebo twice daily for days 1, 2, and 3
Placebo: Placebo daily for days 4-14"
74168|NCT01936844|P1|Participant Flow|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14
Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3
Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
74169|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.
Placebo: Placebo twice daily for days 1, 2, and 3
Placebo: Placebo daily for days 4-14"
74299|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
74300|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
74170|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14
Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3
Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
74171|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.
Placebo: Placebo twice daily for days 1, 2, and 3
Placebo: Placebo daily for days 4-14"
74172|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14
Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3
Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
74173|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.
Placebo: Placebo twice daily for days 1, 2, and 3
Placebo: Placebo daily for days 4-14"
74174|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14
Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3
Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
74175|NCT01936844|E2|Reported Event|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.
Placebo: Placebo twice daily for days 1, 2, and 3
Placebo: Placebo daily for days 4-14"
74176|NCT01936844|E1|Reported Event|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14
Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3
Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
74177|NCT01936662|B3|Baseline|Total|Total of all reporting groups
74178|NCT01936662|B2|Baseline|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
74179|NCT01936662|B1|Baseline|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
74180|NCT01936662|P2|Participant Flow|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
74181|NCT01936662|P1|Participant Flow|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
74182|NCT01936662|O2|Outcome|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
74183|NCT01936662|O1|Outcome|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
74184|NCT01936662|O2|Outcome|Endotracheal Tube for EGD Procedure|"Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
ETT: Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital"
74185|NCT01936662|O1|Outcome|Largyngeal Mask Airway for EGD Procedure|"Patients randomized to LMA to maintain airway through EGD procedure
LMA: Patients randomized to the LMA group had their airways maintained with a LMA device"
74186|NCT01936662|E2|Reported Event|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
74187|NCT01936662|E1|Reported Event|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
74188|NCT01936649|B1|Baseline|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
74189|NCT01936649|P1|Participant Flow|AdreView (Iobenguane I 123 Injection)|Two administrations of single intravenous (i.v.) injection of Iobenguane I 123 10 millicuries (mCi) (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
74190|NCT01936649|O1|Outcome|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
74191|NCT01936649|O1|Outcome|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
74192|NCT01936649|E1|Reported Event|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
74193|NCT01936623|B3|Baseline|Total|Total of all reporting groups
74194|NCT01936623|B2|Baseline|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.
Computerized Brief Intervention: No additional information needed."
74195|NCT01936623|B1|Baseline|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.
Computerized Brief Intervention: No additional information needed."
74196|NCT01936623|P2|Participant Flow|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.
Computerized Brief Intervention: No additional information needed."
74197|NCT01936623|P1|Participant Flow|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.
Computerized Brief Intervention: No additional information needed."
74198|NCT01936623|O2|Outcome|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.
Computerized Brief Intervention: No additional information needed."
74199|NCT01936623|O1|Outcome|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.
Computerized Brief Intervention: No additional information needed."
74200|NCT01936623|O2|Outcome|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.
Computerized Brief Intervention: No additional information needed."
74201|NCT01936623|O1|Outcome|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.
Computerized Brief Intervention: No additional information needed."
74202|NCT01936623|O2|Outcome|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.
Computerized Brief Intervention: No additional information needed."
74203|NCT01936623|O1|Outcome|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.
Computerized Brief Intervention: No additional information needed."
74204|NCT01936623|O2|Outcome|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.
Computerized Brief Intervention: No additional information needed."
74205|NCT01936623|O1|Outcome|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.
Computerized Brief Intervention: No additional information needed."
74206|NCT01936623|E2|Reported Event|Delayed Computerized Brief Intervention|"Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.
Computerized Brief Intervention: No additional information needed."
74207|NCT01936623|E1|Reported Event|Computerized Brief Intervention|"Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.
Computerized Brief Intervention: No additional information needed."
74208|NCT01936467|B3|Baseline|Total|Total of all reporting groups
74209|NCT01936467|B2|Baseline|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
74318|NCT01934894|P2|Participant Flow|Dose Level 2 (Level 1 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
94745|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
74210|NCT01936467|B1|Baseline|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
74211|NCT01936467|P2|Participant Flow|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
74212|NCT01936467|P1|Participant Flow|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
74213|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
74214|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
74215|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
74216|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
74217|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
74218|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
74219|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
74220|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
74221|NCT01936467|O2|Outcome|Patients With Negative Gold Standard|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
74222|NCT01936467|O1|Outcome|Patients With Positive Gold Standard|gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up.
74223|NCT01936467|O2|Outcome|Patients With Negative Gold Standard|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
74224|NCT01936467|O1|Outcome|Patients With Positive Gold Standard|gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up.
74225|NCT01936467|O1|Outcome|Standard Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
74226|NCT01936467|O1|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
74227|NCT01936467|E2|Reported Event|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
74228|NCT01936467|E1|Reported Event|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
74229|NCT01936389|B3|Baseline|Total|Total of all reporting groups
74230|NCT01936389|B2|Baseline|0.7%|"0.7% Rho-Kinase Inhibitor
AR-12286"
74231|NCT01936389|B1|Baseline|0.5%|"0.5% Rho-Kinase Inhibitor
AR-12286"
74232|NCT01936389|P2|Participant Flow|0.7%|"0.7% Rho-Kinase Inhibitor
AR-12286"
74233|NCT01936389|P1|Participant Flow|0.5%|"0.5% Rho-Kinase Inhibitor
AR-12286"
74234|NCT01936389|O2|Outcome|0.7%|"0.7% Rho-Kinase Inhibitor
AR-12286"
74235|NCT01936389|O1|Outcome|0.5%|"0.5% Rho-Kinase Inhibitor
AR-12286"
74236|NCT01936389|E2|Reported Event|0.7%|"0.7% Rho-Kinase Inhibitor
AR-12286"
74237|NCT01936389|E1|Reported Event|0.5%|"0.5% Rho-Kinase Inhibitor
AR-12286"
74238|NCT01936363|B3|Baseline|Total|Total of all reporting groups
74239|NCT01936363|B2|Baseline|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74301|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
74240|NCT01936363|B1|Baseline|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74241|NCT01936363|P2|Participant Flow|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74242|NCT01936363|P1|Participant Flow|Pimasertib (Once Daily) Plus SAR245409|Subjects received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74243|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74244|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74245|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74246|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74579|NCT01933425|O1|Outcome|Deep Neuromuscular Block|Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).
74247|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74248|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74249|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74250|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74251|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74252|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74253|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74254|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74255|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74256|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74257|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74258|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74259|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74260|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74261|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74262|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74263|NCT01936363|E2|Reported Event|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74264|NCT01936363|E1|Reported Event|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
74265|NCT01936181|B3|Baseline|Total|Total of all reporting groups
74266|NCT01936181|B2|Baseline|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
74267|NCT01936181|B1|Baseline|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)"
74268|NCT01936181|P4|Participant Flow|Remicade (Infliximab), Continue as Remicade|"Remicade 3mg/kg at week 54, 62, 70
Remicade (infliximab)"
74269|NCT01936181|P3|Participant Flow|Remicade (Infliximab), Switch to SB2|"SB2 3mg/kg at week 54, 62, 70
SB2 (proposed biosimilar to infliximab)"
74580|NCT01933425|O2|Outcome|No Neuromuscular Block|Intraabdominal distance during no neuromuscular block
74270|NCT01936181|P2|Participant Flow|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
74271|NCT01936181|P1|Participant Flow|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)"
74272|NCT01936181|O5|Outcome|Remicade (Infliximab), Continue as Remicade|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised to continue on Remicade (Remicade/Remicade) up to Week 70 and received Remicade 3mg/kg at week 54, 62, 70."
74273|NCT01936181|O4|Outcome|Remicade (Infliximab), Switch to SB2 at Week 78|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised to be transitioned to SB2 (Remicade/SB2) up to Week 70 and received SB2 3mg/kg at week 54, 62, 70.
SB2 (proposed biosimilar to infliximab)"
74274|NCT01936181|O3|Outcome|SB2 at Week 78|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)"
74275|NCT01936181|O2|Outcome|Remicade (Infliximab) at Week 54|Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
74276|NCT01936181|O1|Outcome|SB2 at Week 54|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)"
74277|NCT01936181|O2|Outcome|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
74278|NCT01936181|O1|Outcome|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)"
74279|NCT01936181|E2|Reported Event|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
74280|NCT01936181|E1|Reported Event|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)"
74281|NCT01935622|B4|Baseline|Total|Total of all reporting groups
74282|NCT01935622|B3|Baseline|Placebo|"Placebo
placebo"
74283|NCT01935622|B2|Baseline|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days
Doxycycline"
74284|NCT01935622|B1|Baseline|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days
Doxycycline"
74285|NCT01935622|P3|Participant Flow|Placebo|"Placebo
placebo"
74286|NCT01935622|P2|Participant Flow|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days
Doxycycline"
74287|NCT01935622|P1|Participant Flow|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days
Doxycycline"
74288|NCT01935622|O3|Outcome|Placebo|"Placebo
placebo"
74289|NCT01935622|O2|Outcome|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days
Doxycycline"
74290|NCT01935622|O1|Outcome|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days
Doxycycline"
74291|NCT01935622|E3|Reported Event|Placebo|"Placebo
placebo"
74292|NCT01935622|E2|Reported Event|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days
Doxycycline"
74293|NCT01935622|E1|Reported Event|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days
Doxycycline"
74294|NCT01935180|B3|Baseline|Total|Total of all reporting groups
74295|NCT01935180|B2|Baseline|Cap Assisted Colonoscopy|"A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope."
74296|NCT01935180|B1|Baseline|Standard Colonoscopy|Standard colonoscopy without an attachment cap
74297|NCT01935180|P2|Participant Flow|Cap Assisted Colonoscopy|"A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope."
74298|NCT01935180|P1|Participant Flow|Standard Colonoscopy|Standard colonoscopy without an attachment cap
74302|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
74303|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
74304|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
74305|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
74306|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
74307|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
74308|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
74309|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
74310|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
74311|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
74312|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
74313|NCT01935180|E2|Reported Event|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
74314|NCT01935180|E1|Reported Event|Standard Colonoscopy|Colonoscopy without a cap.
74315|NCT01934894|B3|Baseline|Total|Total of all reporting groups
74316|NCT01934894|B2|Baseline|Dose Level 2 (Level 1 (25 mg/m2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74317|NCT01934894|B1|Baseline|Dose Level 1 (20 mg/m2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74581|NCT01933425|O1|Outcome|Deep Neuromuscular Block|Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).
74319|NCT01934894|P1|Participant Flow|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74320|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74321|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74322|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74323|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74324|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74325|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74326|NCT01934894|O2|Outcome|Dose Level 2|Cabazitaxel 25mg/m^2:: 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74327|NCT01934894|O1|Outcome|Dose Level 1|Cabazitaxel: 20 mg/m^2: 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74328|NCT01934894|O1|Outcome|Cabazitaxel and Lapatinib|Cabazitaxel: (at Dose Level 1, 20 mg/m^2 or at Dose Level 2, 25 mg/m^2), 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74329|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74330|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74331|NCT01934894|E2|Reported Event|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74332|NCT01934894|E1|Reported Event|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
74333|NCT01934790|B1|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74334|NCT01934790|P1|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74335|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74336|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74337|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74338|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74339|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74340|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74341|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74342|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74343|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74344|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74345|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74346|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74347|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74348|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74349|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74350|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74351|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74352|NCT01934790|E1|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
74428|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
74353|NCT01934582|B1|Baseline|Open-label Extension PK Population|The PK population included all subjects enrolled in the PK substudy having met the study criteria, who had sufficient treprostinil concentration-time data to derive noncompartmental PK parameters for at least 1 treatment of open-label treprostinil diethanolamine.
74354|NCT01934582|P1|Participant Flow|Open-label Extension PK Population|The PK population included all subjects enrolled in the PK substudy having met the study criteria who received at least 1 treatment of open-label treprostinil diethanolamine.
74355|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
74356|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
74357|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
74358|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
74359|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
74360|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
74361|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
74362|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
74363|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
74364|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
74365|NCT01934582|E2|Reported Event|PK Visit 2|UT-15C SR (treprostinil diethanolamine): open-label study drug
74366|NCT01934582|E1|Reported Event|PK Visit 1|UT-15C SR (treprostinil diethanolamine): open-label study drug
74367|NCT01934517|B1|Baseline|iTero, Lava Digital and Plaster Models|All study participants: iTero, LavaDigital and plaster models (single-group study)
74368|NCT01934517|P1|Participant Flow|iTero, Lava Digital and Plaster Models: All Study Participants|"Single-group study:
ITero models obtained from intraoral scans with iTero scanner
Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
Lava Digital models obtained from extraoral scans of plaster models"
74369|NCT01934517|O3|Outcome|Lava Digital Models|Lava Digital models obtained from extraoral scans of plaster models
74370|NCT01934517|O2|Outcome|Plaster Models|Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
74371|NCT01934517|O1|Outcome|iTero Models|ITero models obtained from intraoral scans with iTero scanner
74372|NCT01934517|E3|Reported Event|Lava Digital Models|Lava Digital models obtained from extraoral scans of plaster models
74373|NCT01934517|E2|Reported Event|Plaster Models|Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
74374|NCT01934517|E1|Reported Event|iTero Models|ITero models obtained from intraoral scans with iTero scanner
74375|NCT01934504|B5|Baseline|Total|Total of all reporting groups
74376|NCT01934504|B4|Baseline|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
74377|NCT01934504|B3|Baseline|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74378|NCT01934504|B2|Baseline|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74379|NCT01934504|B1|Baseline|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74414|NCT01934218|B2|Baseline|Placebo|The participants received a single intra-articular injection of PBS.
74380|NCT01934504|P4|Participant Flow|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
74381|NCT01934504|P3|Participant Flow|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74382|NCT01934504|P2|Participant Flow|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74383|NCT01934504|P1|Participant Flow|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74429|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
74699|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74384|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
74385|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74386|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74387|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74388|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
74389|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74390|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74391|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74392|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
74393|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74394|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74395|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74415|NCT01934218|B1|Baseline|Gel-One|The participants received a single intra-articular injection of Gel-One.
74416|NCT01934218|P2|Participant Flow|Placebo|The participants received a single intra-articular injection of Phosphate Buffered Saline (PBS).
74417|NCT01934218|P1|Participant Flow|Gel-One|The participants received a single intra-articular injection of Gel-One.
74396|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
74397|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74398|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74399|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74400|NCT01934504|E4|Reported Event|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
74401|NCT01934504|E3|Reported Event|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74402|NCT01934504|E2|Reported Event|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74403|NCT01934504|E1|Reported Event|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
74404|NCT01934231|B1|Baseline|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
74405|NCT01934231|P1|Participant Flow|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
74406|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
74407|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
74408|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
74409|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
74410|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
74411|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
74412|NCT01934231|E1|Reported Event|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
74413|NCT01934218|B3|Baseline|Total|Total of all reporting groups
78367|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
74418|NCT01934218|O1|Outcome|Gel-One|The participants received a single intra-articular injection of Gel-One.
74419|NCT01934218|O2|Outcome|Placebo|The participants received a single intra-articular injection of PBS.
74420|NCT01934218|O1|Outcome|Gel-One|The participants received a single intra-articular injection of Gel-One.
74421|NCT01934218|E2|Reported Event|Placebo|3 mL, a single intra-articular injection of PBS.
74422|NCT01934218|E1|Reported Event|Gel-One|3 mL, a single intra-articular injection of Gel-One.
74423|NCT01933932|B3|Baseline|Total|Total of all reporting groups
74424|NCT01933932|B2|Baseline|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
74425|NCT01933932|B1|Baseline|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
74426|NCT01933932|P2|Participant Flow|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
74427|NCT01933932|P1|Participant Flow|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
96166|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
74430|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
74431|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
74432|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
74433|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
74434|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
74435|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
74436|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
74437|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
74438|NCT01933932|O2|Outcome|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
74439|NCT01933932|O1|Outcome|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
74440|NCT01933932|E2|Reported Event|Selumetinib + Docetaxel|Three 25mg selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
74441|NCT01933932|E1|Reported Event|Placebo + Docetaxel|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
74442|NCT01933880|B3|Baseline|Total|Total of all reporting groups
74443|NCT01933880|B2|Baseline|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74444|NCT01933880|B1|Baseline|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74445|NCT01933880|P2|Participant Flow|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74446|NCT01933880|P1|Participant Flow|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74447|NCT01933880|O2|Outcome|Normal|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74448|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74449|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d).
78368|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
74450|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d).
74451|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
74452|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d).
74453|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
74454|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
74455|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
74456|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
74457|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
74458|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
74459|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
74460|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
74461|NCT01933880|O2|Outcome|Normal|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74462|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74463|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74464|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74465|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74466|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74467|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74468|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74469|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74470|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74471|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74472|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74473|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74474|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74475|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74476|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74477|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74478|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74479|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74480|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74481|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74482|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74483|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
79423|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
74484|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74485|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74486|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74487|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74488|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74489|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74490|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74491|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74492|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74493|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74494|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74495|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74496|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74497|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74498|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74499|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
78369|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
74500|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74501|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74502|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74503|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74504|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74505|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74506|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74507|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
74508|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74509|NCT01933880|E1|Reported Event|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
74510|NCT01933776|B3|Baseline|Total|Total of all reporting groups
74511|NCT01933776|B2|Baseline|ADACEL™ Vaccine Group 2|Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
74512|NCT01933776|B1|Baseline|ADACEL™ Vaccine Group 1|Adults 18 to 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
74513|NCT01933776|P2|Participant Flow|ADACEL™ Vaccine Group 2 (Children)|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
74514|NCT01933776|P1|Participant Flow|ADACEL™ Vaccine Group 1 (Adults)|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
74515|NCT01933776|O2|Outcome|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
74516|NCT01933776|O1|Outcome|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
74517|NCT01933776|O2|Outcome|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
74518|NCT01933776|O1|Outcome|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
74519|NCT01933776|E2|Reported Event|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
74520|NCT01933776|E1|Reported Event|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
74521|NCT01933672|B1|Baseline|All*|A total of 90 participants with T2DM were consented for this study; of these, 43 transitioned into run-in with Sponsor-provided metformin and a total of 33 participants were randomized.
74522|NCT01933672|P7|Participant Flow|Sitagliptin Then PF-04937319 300mg Then PF-04937319 150+100mg|Participants received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the third intervention period.
74534|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74535|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74523|NCT01933672|P6|Participant Flow|Sitagliptin Then PF-04937319 150+100mg Then PF-04937319 300mg|Participants received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
74524|NCT01933672|P5|Participant Flow|PF-04937319 300mg Then Sitagliptin Then PF-04937319 150+100mg|Participants received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period.
74525|NCT01933672|P4|Participant Flow|PF-04937319 300mg Then PF-04937319 150+100mg Then Sitagliptin|Participants received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the second intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days.
74526|NCT01933672|P3|Participant Flow|PF-04937319 150+100mg Then Sitagliptin Then PF-04937319 300mg|Participants received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
74527|NCT01933672|P2|Participant Flow|PF-04937319 150+100mg Then PF-04937319 300mg Then Sitagliptin|Participants received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
74528|NCT01933672|P1|Participant Flow|Metformin Run-in|Sponsor-provided, open-label metformin was administered from the run-in visit to the follow-up visit, inclusive, and it was provided as 500 milligram (mg) immediate-release tablets.
74529|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74530|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74531|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74532|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74533|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74536|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74537|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74538|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74539|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74577|NCT01933425|O1|Outcome|Deep Neuromuscular Blockade|"Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.
Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade
rocuronium
sugammadex
placebo"
74540|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74541|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74542|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74543|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74544|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74545|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74546|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74547|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74548|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74549|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74550|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74551|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74552|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74553|NCT01933672|O4|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74554|NCT01933672|O3|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74555|NCT01933672|O2|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74556|NCT01933672|O1|Outcome|Metformin Run-in|Participants were instructed to take the morning dose of the study medication and at least 1 dose of open label metformin at the same time of day with the morning meal each day.
74557|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74578|NCT01933425|O2|Outcome|No Neuromuscular Block|Intraabdominal distance during no neuromuscular block
74558|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74559|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74560|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74561|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74562|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74563|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74564|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74565|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74566|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74567|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74568|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74569|NCT01933672|E4|Reported Event|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74570|NCT01933672|E3|Reported Event|PF-04937319 300 mg (Once Daily)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
74571|NCT01933672|E2|Reported Event|PF-04937319 150+100 mg (Split Dose)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
75147|NCT01930045|E2|Reported Event|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
74572|NCT01933672|E1|Reported Event|Metformin Run-in|Sponsor-provided, open-label metformin was administered from the run-in visit to the follow-up visit, inclusive, and it was provided as 500 mg immediate-release tablets.
74573|NCT01933425|B1|Baseline|Patient Characteristics in 14 Women|
74574|NCT01933425|P2|Participant Flow|No Neuromuscular Block First Then Deep Neuromuscular Block|"No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.
Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.
rocuronium
sugammadex
placebo"
74575|NCT01933425|P1|Participant Flow|Deep Neuromuscular Block First Then no Neuromuscular Block|"Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.
Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade
rocuronium
sugammadex
placebo"
74576|NCT01933425|O2|Outcome|no Neuromuscular Blockade|"No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.
Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.
rocuronium
sugammadex
placebo"
74582|NCT01933425|E2|Reported Event|No Neuromuscular Block First Then Deep Neuromuscular Block|Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade.
74583|NCT01933425|E1|Reported Event|Deep Neuromuscular Block First Then no Neuromuscular Block|Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade.
74584|NCT01933399|B4|Baseline|Total|Total of all reporting groups
74585|NCT01933399|B3|Baseline|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.
Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
74586|NCT01933399|B2|Baseline|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter
Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
74587|NCT01933399|B1|Baseline|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.
Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
74588|NCT01933399|P3|Participant Flow|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.
Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
74589|NCT01933399|P2|Participant Flow|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter
Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
74590|NCT01933399|P1|Participant Flow|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.
Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
74591|NCT01933399|O3|Outcome|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.
Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
74592|NCT01933399|O2|Outcome|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter
Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
74593|NCT01933399|O1|Outcome|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.
Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
74594|NCT01933399|O3|Outcome|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.
Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
74595|NCT01933399|O2|Outcome|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter
Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
74596|NCT01933399|O1|Outcome|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.
Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
74597|NCT01933399|E3|Reported Event|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.
Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
74598|NCT01933399|E2|Reported Event|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter
Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
74599|NCT01933399|E1|Reported Event|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.
Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
74600|NCT01933334|B3|Baseline|Total|Total of all reporting groups
74601|NCT01933334|B2|Baseline|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
74602|NCT01933334|B1|Baseline|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
74603|NCT01933334|P2|Participant Flow|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
74604|NCT01933334|P1|Participant Flow|Pirfenidone: 2-Week Titration Group|Participants received one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day [mg/day]) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
74605|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
96167|NCT01806857|O2|Outcome|Matching Placebo|
74606|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
74607|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
74608|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
74609|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
74610|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
74611|NCT01933334|E2|Reported Event|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
74612|NCT01933334|E1|Reported Event|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
74613|NCT01933230|B1|Baseline|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).
We will place an Excel Cryo Cooling System collar around your neck for two hours. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).
2 hour neck cooling period"
74614|NCT01933230|P1|Participant Flow|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).
Excel Cryo Cooling System: We will place an Excel Cryo Cooling System collar around your neck for two hours."
74615|NCT01933230|O1|Outcome|Excel Cryo Cooling System Collar|We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).
74616|NCT01933230|E1|Reported Event|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for two hours. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).
2 hour neck cooling period"
74617|NCT01932970|B1|Baseline|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
74618|NCT01932970|P1|Participant Flow|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
74619|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
74620|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
74621|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
74622|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
74623|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
74624|NCT01932970|E1|Reported Event|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
74625|NCT01932762|B5|Baseline|Total|Total of all reporting groups
74626|NCT01932762|B4|Baseline|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
74627|NCT01932762|B3|Baseline|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74628|NCT01932762|B2|Baseline|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
74629|NCT01932762|B1|Baseline|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74630|NCT01932762|P4|Participant Flow|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
74631|NCT01932762|P3|Participant Flow|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74632|NCT01932762|P2|Participant Flow|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
74633|NCT01932762|P1|Participant Flow|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of ribavirin (RBV) for 12 weeks.
74634|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
74635|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74636|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
74637|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74638|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
74639|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74640|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
74641|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74642|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
74643|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74644|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
74645|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74646|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
74647|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74648|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
74649|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74650|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
74651|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74652|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
74653|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74654|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
74655|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74656|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
79424|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
74657|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74658|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
74659|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74660|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
74661|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74662|NCT01932762|E4|Reported Event|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
74663|NCT01932762|E3|Reported Event|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74664|NCT01932762|E2|Reported Event|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
74665|NCT01932762|E1|Reported Event|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
74666|NCT01932606|B3|Baseline|Total|Total of all reporting groups
74667|NCT01932606|B2|Baseline|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74668|NCT01932606|B1|Baseline|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74669|NCT01932606|P2|Participant Flow|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74670|NCT01932606|P1|Participant Flow|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74671|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74672|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74673|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74674|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74675|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74676|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74677|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74678|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74679|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74680|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74681|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74682|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74683|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74684|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74685|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
75148|NCT01930045|E1|Reported Event|Raltegravir|400 mg Raltegravir alone
74686|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74687|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74688|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74689|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74690|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74691|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74692|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74693|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74694|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74695|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74696|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74697|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74698|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
79425|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
74700|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74701|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74702|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74703|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74704|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74705|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74706|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74707|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74708|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74709|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74710|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74711|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74712|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74713|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74714|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74715|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74716|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74717|NCT01932606|E2|Reported Event|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
74718|NCT01932606|E1|Reported Event|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
74719|NCT01932164|B1|Baseline|Cleft Lip and Palate|"5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery
maxillary alveolar graft by tissue engineering: Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;
Bone tissue engineering using mesenchymal stem cells: Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
74720|NCT01932164|P1|Participant Flow|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment
maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
74721|NCT01932164|O1|Outcome|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment
maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
74805|NCT01931839|B7|Baseline|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
74722|NCT01932164|E1|Reported Event|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment
maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
74723|NCT01932112|B1|Baseline|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
74724|NCT01932112|P1|Participant Flow|Adenosine Arm|"After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Adenosine arm: After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
74725|NCT01932112|O1|Outcome|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Adenosine arm: After pulmonary vein isolation, 12mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
74726|NCT01932112|E1|Reported Event|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
74727|NCT01932060|B3|Baseline|Total|Total of all reporting groups
74728|NCT01932060|B2|Baseline|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
74729|NCT01932060|B1|Baseline|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
74730|NCT01932060|P2|Participant Flow|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
74731|NCT01932060|P1|Participant Flow|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
74732|NCT01932060|O2|Outcome|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
74733|NCT01932060|O1|Outcome|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
74734|NCT01932060|O2|Outcome|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
74735|NCT01932060|O1|Outcome|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
74736|NCT01932060|E2|Reported Event|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
74737|NCT01932060|E1|Reported Event|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
74738|NCT01931956|B3|Baseline|Total|Total of all reporting groups
74739|NCT01931956|B2|Baseline|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74740|NCT01931956|B1|Baseline|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74806|NCT01931839|B6|Baseline|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
74741|NCT01931956|P2|Participant Flow|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74742|NCT01931956|P1|Participant Flow|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74743|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74794|NCT01931878|O2|Outcome|Xeomin|incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
74795|NCT01931878|O1|Outcome|Placebo|In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections.
74744|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74745|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74746|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74747|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74748|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74749|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74750|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74751|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74752|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
75149|NCT01929993|B3|Baseline|Total|Total of all reporting groups
74753|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74754|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74755|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
96168|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
74756|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74757|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74758|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74759|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74760|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74761|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74762|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74763|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74764|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
75103|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
74765|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74766|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74767|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74768|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74769|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74770|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74771|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74772|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74773|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74774|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74775|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74776|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
75104|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
74777|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74778|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74779|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74780|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74781|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74782|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74783|NCT01931956|O2|Outcome|Emergency Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74784|NCT01931956|O1|Outcome|Compassionate Use|Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
74785|NCT01931956|E2|Reported Event|Emergency Use|"Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
MitraClip® implant: Percutaneous mitral valve repair using MitraClip implant"
74786|NCT01931956|E1|Reported Event|Compassionate Use|"Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
MitraClip® implant: Percutaneous mitral valve repair using MitraClip implant"
74787|NCT01931878|B1|Baseline|All Study Participants|"The subject may be randomly assigned to receive Placebo, saline
Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
74788|NCT01931878|P2|Participant Flow|IncobotulinumtoxinA First, Then Placebo|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)
incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo."
74789|NCT01931878|P1|Participant Flow|Placebo First, Then Incobotulinumtoxin A|Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug.
74790|NCT01931878|O2|Outcome|IncobotulinumtoxinA Treatment|incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
74791|NCT01931878|O1|Outcome|Placebo , Saline|Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design.
74792|NCT01931878|O2|Outcome|Xeomin|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)
incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions."
74793|NCT01931878|O1|Outcome|Placebo|"The subject may be randomly assigned to receive Placebo, saline
Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo."
75632|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
74796|NCT01931878|E2|Reported Event|IncobotulinumtoxinA Treatment|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)
incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
74797|NCT01931878|E1|Reported Event|Placebo , Saline|"The subject may be randomly assigned to receive Placebo, saline
Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
74798|NCT01931865|B1|Baseline|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.
IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
74799|NCT01931865|P1|Participant Flow|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.
IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
74800|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.
IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
74801|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The ttoal dose will not exceed 100 units.
IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
74802|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.
IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
74803|NCT01931865|E1|Reported Event|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.
IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
74804|NCT01931839|B8|Baseline|Total|Total of all reporting groups
75105|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
74807|NCT01931839|B5|Baseline|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
74808|NCT01931839|B4|Baseline|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
74809|NCT01931839|B3|Baseline|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
74810|NCT01931839|B2|Baseline|q12h Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
74811|NCT01931839|B1|Baseline|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
74873|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
74812|NCT01931839|P7|Participant Flow|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
74813|NCT01931839|P6|Participant Flow|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
74814|NCT01931839|P5|Participant Flow|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
74815|NCT01931839|P4|Participant Flow|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
74816|NCT01931839|P3|Participant Flow|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
74817|NCT01931839|P2|Participant Flow|Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
74818|NCT01931839|P1|Participant Flow|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
74819|NCT01931839|O1|Outcome|Arm 5: Part A Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening or LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening or placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), were observed (did not receive study drug) in this study VX12-809-105 (NCT01931839) for up to 2 years.
74820|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211).
74821|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211).
74822|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74823|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
74824|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74825|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
74826|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
75106|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
74827|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
74828|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74829|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
74830|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74831|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
74872|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74832|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74833|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
74834|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74835|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
74836|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74837|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74838|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74839|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74840|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74841|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74842|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74843|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74844|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74845|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
74846|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74847|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74848|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74849|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74850|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74851|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
74954|NCT01930890|B5|Baseline|Total|Total of all reporting groups
75538|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
74852|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74853|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
74854|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74855|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
74856|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74857|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74858|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74859|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74860|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74861|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
74862|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74863|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74864|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74865|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74866|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74867|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
74943|NCT01931397|O1|Outcome|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
74868|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74869|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74870|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74871|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74874|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74875|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74876|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
74877|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
74878|NCT01931839|E7|Reported Event|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
74879|NCT01931839|E6|Reported Event|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
74880|NCT01931839|E5|Reported Event|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
74881|NCT01931839|E4|Reported Event|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
74882|NCT01931839|E3|Reported Event|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
74883|NCT01931839|E2|Reported Event|Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
74884|NCT01931839|E1|Reported Event|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
74885|NCT01931709|B1|Baseline|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
fludeoxyglucose F 18: Undergo FDG PET
positron emission tomography: Undergo FDG PET
dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI
laboratory biomarker analysis: Correlative studies"
74886|NCT01931709|P1|Participant Flow|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
fludeoxyglucose F 18: Undergo FDG PET
positron emission tomography: Undergo FDG PET
dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI
laboratory biomarker analysis: Correlative studies"
75107|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
74887|NCT01931709|O2|Outcome|Patients Without Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease)."
74888|NCT01931709|O1|Outcome|Patients With Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
Pathologic response at surgery rated as residual cancer burden (RCB) class 0 / I (complete pathologic response or minimal residual disease)."
74889|NCT01931709|O2|Outcome|Patients Without Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease)."
74890|NCT01931709|O1|Outcome|Patients With Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
Pathologic response at surgery rated as residual cancer burden (RCB) class 0 / I (complete pathologic response or minimal residual disease)."
74891|NCT01931709|O2|Outcome|Patients Without Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease)."
74892|NCT01931709|O1|Outcome|Patients With Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
Pathologic response at surgery rated as residual cancer burden (RCB) class 0 / I (complete pathologic response or minimal residual disease)."
74893|NCT01931709|O1|Outcome|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
fludeoxyglucose F 18: Undergo FDG PET
positron emission tomography: Undergo FDG PET
dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI
laboratory biomarker analysis: Correlative studies"
74894|NCT01931709|E1|Reported Event|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
fludeoxyglucose F 18: Undergo FDG PET
positron emission tomography: Undergo FDG PET
dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI
laboratory biomarker analysis: Correlative studies"
74895|NCT01931527|B3|Baseline|Total|Total of all reporting groups
74896|NCT01931527|B2|Baseline|High Uric Acid|15 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid >6mg/dL
74897|NCT01931527|B1|Baseline|Low Uric Acid|16 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid <5mg/dL
74898|NCT01931527|P2|Participant Flow|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)
Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min
Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
74899|NCT01931527|P1|Participant Flow|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
74900|NCT01931527|O2|Outcome|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)
Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min
Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
74901|NCT01931527|O1|Outcome|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
74902|NCT01931527|O2|Outcome|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)
Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min
Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
74903|NCT01931527|O1|Outcome|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
74904|NCT01931527|E2|Reported Event|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)
Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min
Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
74905|NCT01931527|E1|Reported Event|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
74906|NCT01931475|B3|Baseline|Total|Total of all reporting groups
74907|NCT01931475|B2|Baseline|Placebo|"Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
74908|NCT01931475|B1|Baseline|60 mg Duloxetine|"Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
74944|NCT01931397|E1|Reported Event|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
74909|NCT01931475|P2|Participant Flow|Placebo|"Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment.1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
74910|NCT01931475|P1|Participant Flow|60 mg Duloxetine|"Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
74911|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
74912|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
74913|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
74914|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
74915|NCT01931475|O1|Outcome|All Participants (60 mg Duloxetine & Placebo)|"Duloxetine:
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg.
Placebo:
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase:
1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment."
74916|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
74917|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
74918|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
74919|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
74920|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
74945|NCT01931150|B3|Baseline|Total|Total of all reporting groups
75108|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
74921|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
74922|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
74923|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
74924|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
75633|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
74925|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
74926|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
74927|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
74928|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
74929|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
74930|NCT01931475|E6|Reported Event|Placebo Taper|Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
74931|NCT01931475|E5|Reported Event|60 mg Duloxetine Taper|1-week taper - participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
74932|NCT01931475|E4|Reported Event|Placebo/60 mg Duloxetine Extention|60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
74933|NCT01931475|E3|Reported Event|60 mg Duloxetine Extention|60 mg duloxetine administered by mouth QD for 13 weeks.
74934|NCT01931475|E2|Reported Event|Placebo Double Blind|Placebo administered by mouth once a day (QD) for 13 weeks.
74935|NCT01931475|E1|Reported Event|60 mg Duloxetine Double Blind|60 mg duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
74936|NCT01931397|B1|Baseline|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
74937|NCT01931397|P1|Participant Flow|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
74938|NCT01931397|O1|Outcome|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
74939|NCT01931397|O2|Outcome|Group 2|Participants less than 12 years of age
74940|NCT01931397|O1|Outcome|Group 1|Participants 12 years and over
74941|NCT01931397|O2|Outcome|At End of Study|Numbers of families at end of study
74942|NCT01931397|O1|Outcome|At Time of Enrollment|Number of families at enrollment
74946|NCT01931150|B2|Baseline|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
74947|NCT01931150|B1|Baseline|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
74948|NCT01931150|P2|Participant Flow|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
74949|NCT01931150|P1|Participant Flow|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
74950|NCT01931150|O2|Outcome|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
74951|NCT01931150|O1|Outcome|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
74952|NCT01931150|E2|Reported Event|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
74953|NCT01931150|E1|Reported Event|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
74955|NCT01930890|B4|Baseline|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74956|NCT01930890|B3|Baseline|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74957|NCT01930890|B2|Baseline|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74958|NCT01930890|B1|Baseline|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74959|NCT01930890|P4|Participant Flow|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74960|NCT01930890|P3|Participant Flow|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74961|NCT01930890|P2|Participant Flow|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74962|NCT01930890|P1|Participant Flow|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus mycophenolate mofetil (MMF) and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg intavenously (IV) Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74963|NCT01930890|O4|Outcome|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74964|NCT01930890|O3|Outcome|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74965|NCT01930890|O2|Outcome|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74966|NCT01930890|O1|Outcome|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74967|NCT01930890|O4|Outcome|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74968|NCT01930890|O3|Outcome|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74969|NCT01930890|O2|Outcome|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74970|NCT01930890|O1|Outcome|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74971|NCT01930890|E4|Reported Event|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
75100|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
74972|NCT01930890|E3|Reported Event|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74973|NCT01930890|E2|Reported Event|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74974|NCT01930890|E1|Reported Event|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
74975|NCT01930799|B1|Baseline|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
74976|NCT01930799|P1|Participant Flow|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
74977|NCT01930799|O1|Outcome|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
74978|NCT01930799|O1|Outcome|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
74979|NCT01930799|E1|Reported Event|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
74980|NCT01930487|B1|Baseline|Participants Completing Study|Participants who completed both arms of the crossover study
74981|NCT01930487|P2|Participant Flow|Placebo, Then Supplement With Antioxidants|placebo supplement in the second intervention period, followed by dietary supplement with antioxidants in the second intervention period
74982|NCT01930487|P1|Participant Flow|Supplement With Antioxidants, Then Placebo|dietary supplement with antioxidants in the first intervention period, followed by placebo supplement in the second intervention period
74983|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
74984|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
74985|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
74986|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
74987|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
74988|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
74989|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
74990|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
74991|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
74992|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
74993|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
74994|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
74995|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
74996|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
74997|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
74998|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
74999|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75000|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75001|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
78370|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
75002|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75003|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75004|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75005|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75006|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75007|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75008|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75009|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75010|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
79426|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
75011|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75012|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75013|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75014|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75015|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75016|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75017|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75018|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75019|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75020|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75021|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75022|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75023|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75024|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75025|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75026|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75027|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75028|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75029|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75030|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75031|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75101|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
75032|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75033|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75034|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75035|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75036|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75037|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75038|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75039|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75040|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75041|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75042|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75043|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75044|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75045|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75046|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75047|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75048|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75049|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75050|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75051|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75052|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75053|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75054|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75055|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75056|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75057|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75058|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75059|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75060|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75061|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75102|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
75062|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75063|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75064|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75065|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75066|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75067|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75068|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75069|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75070|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75071|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
75072|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75073|NCT01930487|E2|Reported Event|Placebo|"placebo supplement
Placebo: Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants"
75074|NCT01930487|E1|Reported Event|Supplement w/ Antioxidants|"dietary supplement with antioxidants
dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
75075|NCT01930435|B1|Baseline|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
Sterile Humidification Device"
75076|NCT01930435|P1|Participant Flow|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
Sterile Humidification Device"
75077|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
Sterile Humidification Device"
75078|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
Sterile Humidification Device"
75079|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
Sterile Humidification Device"
75080|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
Sterile Humidification Device: This is a personal humidification device. It is hand held and produces sterile warm vapor."
75081|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
Sterile Humidification Device"
75082|NCT01930435|E1|Reported Event|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
Sterile Humidification Device"
75083|NCT01930162|B1|Baseline|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
75084|NCT01930162|P1|Participant Flow|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
75085|NCT01930162|O1|Outcome|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
75086|NCT01930162|O1|Outcome|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
75087|NCT01930162|O1|Outcome|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
75088|NCT01930162|O1|Outcome|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
75089|NCT01930162|O1|Outcome|HSC835|Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
75090|NCT01930162|E2|Reported Event|Time Period From Day 3 up to End of Study|Adverse Events that occurred 48 hours post-transplant.
75091|NCT01930162|E1|Reported Event|Time Period From Transplant Until 48hrs After Transplant|Adverse events that occurred within the first 48 hours of transplant.
75092|NCT01930058|B4|Baseline|Total|Total of all reporting groups
75093|NCT01930058|B3|Baseline|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
75094|NCT01930058|B2|Baseline|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
75095|NCT01930058|B1|Baseline|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
75096|NCT01930058|P3|Participant Flow|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
75097|NCT01930058|P2|Participant Flow|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
75098|NCT01930058|P1|Participant Flow|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 once daily (q.d.) by mouth for 7 days.
75099|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
75109|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
75110|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
75111|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
75112|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
75113|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
75114|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
75115|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
75116|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
75117|NCT01930058|E2|Reported Event|MK-8876 800 mg|All HCV GT1a and GT3 participants treated with MK-8876 800 mg are included.
75118|NCT01930058|E1|Reported Event|MK-8876 150 mg|All HCV GT3 participants treated with MK-8876 150 mg are included.
75119|NCT01930045|B1|Baseline|All Participants|All enrolled participants
75120|NCT01930045|P6|Participant Flow|Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, MAL followed 4 hrs later by Ralt in Period 2, Ralt alone in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
75634|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75121|NCT01930045|P5|Participant Flow|MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt alone in Period 2, Ralt followed 4 hrs later by MAL in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
75122|NCT01930045|P4|Participant Flow|Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt alone in Period 1, Ralt followed 4 hrs later by MAL in Period 2, MAL followed 4 hrs later by Ralt in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
75123|NCT01930045|P3|Participant Flow|Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, Ralt alone in Period 2, MAL followed 4 hrs later by Ralt in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
75124|NCT01930045|P2|Participant Flow|MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt followed 4 hrs later by MAL in Period 2, Ralt alone in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
75125|NCT01930045|P1|Participant Flow|Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Raltegravir (Ralt) alone in Period 1, MAALOX (MAL) followed 4 hrs later by Ralt in Period 2, Ralt followed 4 hrs later by MAL in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
75126|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
75127|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
75128|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
75129|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
75130|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
75131|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
75132|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
75133|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
75134|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
75135|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
75136|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
75137|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
75138|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
75139|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
75140|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
75141|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
75142|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
75143|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
75144|NCT01930045|E5|Reported Event|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
75145|NCT01930045|E4|Reported Event|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
75146|NCT01930045|E3|Reported Event|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
75150|NCT01929993|B2|Baseline|Large Loop Excision of the Transformation Zone (LLETZ-cone)|Large loop excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
75151|NCT01929993|B1|Baseline|Straight Wire Excision of Transformation Zone (SWETZ)|Straight wire excision of transformation zone (SWETZ) is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.
75152|NCT01929993|P2|Participant Flow|Large Loop Excision of the Transformation Zone (LLETZ-cone)|Large Loop Excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
75153|NCT01929993|P1|Participant Flow|Straight Wire Excision of Transformation Zone (SWETZ)|Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode to remove the dysplastic epithelium of the cervix.
75154|NCT01929993|O2|Outcome|LLETZ Cone|"LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.
LLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin."
75155|NCT01929993|O1|Outcome|SWETZ|"Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.
SWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix."
75156|NCT01929993|E2|Reported Event|LLETZ Cone|"LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.
LLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin."
75157|NCT01929993|E1|Reported Event|SWETZ|"Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.
SWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix."
75158|NCT01929980|B1|Baseline|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.
The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11
Bortezomib"
75159|NCT01929980|P1|Participant Flow|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.
The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11
Bortezomib"
75160|NCT01929980|O1|Outcome|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.
The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11
Bortezomib"
75161|NCT01929980|E1|Reported Event|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.
The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11
Bortezomib"
75162|NCT01929889|B1|Baseline|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
75163|NCT01929889|P1|Participant Flow|A Single Arm, Open Label, Exploratory Study|This is a single arm, open label, exploratory study to examine effects of Fanapt (iloperadone) on social cognition. Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
75164|NCT01929889|O1|Outcome|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
75397|NCT01929044|P1|Participant Flow|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
75165|NCT01929889|E1|Reported Event|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
75166|NCT01929876|B1|Baseline|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75167|NCT01929876|P1|Participant Flow|Cobimetinib + Itraconazole|Cobimetinib 10 milligram (mg) (two 5 mg capsules) administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75168|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75169|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75170|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75171|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75172|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75173|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75174|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75175|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75176|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75177|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75178|NCT01929876|E1|Reported Event|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
75179|NCT01929863|B1|Baseline|All Study Participants|In each treatment period, participants received oral dose of treatment A-metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 or oral dose of treatment B-metformin 850 mg tablet BID plus matchig placebo to GSK2330672 tablet BID for 7 days according to a plan of randomization. The two treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75180|NCT01929863|P2|Participant Flow|Placebo and Metformin, Then Metformin and GSK2330672|Participants received oral dose of treatment B-metformin 850 mg tablet BID plus matching placebo to GSK2330672 tablet BID for 7 days according to a plan of randomization. After a washout period of 13 to 15 days, participants received oral dose of treatment A-metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7. During the washout period, participants received metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75181|NCT01929863|P1|Participant Flow|Metformin and GSK2330672, Then Placebo and Metformin|Participants received oral dose of treatment A-metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 according to a plan of randomization. After a washout period of 13 to 15 days, participants received oral dose of treatment B-metformin 850 mg tablet BID plus matching placebo to GSK2330672 tablet BID for 7 days. During the washout period, participants received metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75182|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75232|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75183|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75184|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75185|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75199|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75539|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75186|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75187|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75188|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75189|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75190|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75191|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75192|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75193|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75194|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75214|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
78371|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
75195|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75196|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75197|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75198|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
96169|NCT01806857|O2|Outcome|Matching Placebo|
75200|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matchig placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75201|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75202|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matchig placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75203|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75204|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75205|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75206|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75207|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75208|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75209|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75210|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75211|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75212|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75213|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75215|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75216|NCT01929863|O3|Outcome|Follow-up-Metformin|After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75217|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75218|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID.
75237|NCT01929681|B1|Baseline|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment
Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75219|NCT01929863|O2|Outcome|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75220|NCT01929863|O1|Outcome|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75221|NCT01929863|E2|Reported Event|Treatment B-Placebo + Metformin|Participants received oral dose of metformin 850 mg tablet BID for 7 days plus matching placebo to GSK2330672 tablet BID for 7 days in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up.
75222|NCT01929863|E1|Reported Event|Treatment A-GSK2330672 + Metformin|Participants received oral dose of metformin 850 mg BID tablet for 7 days plus GSK2330672 45 mg tablet BID on Day 1 and 2 and GSK2330672 90 mg tablet BID on Day 3 to 7 in a sequence of treatment A/B or B/A according to a plan of randomization. Treatment periods were separated by a washout period of 13 to 15 days in which participants continued metformin 850 mg tablet BID. After completion of the double blind treatment period 2 (after the last dose of period 2), participants received oral dose of metformin 850 mg tablet BID for 7-10 days of Follow-up
75223|NCT01929759|B1|Baseline|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75224|NCT01929759|P1|Participant Flow|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75225|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75226|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75227|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75228|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75229|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75230|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75231|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75398|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
75233|NCT01929759|O1|Outcome|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75234|NCT01929759|E1|Reported Event|Drug Switching|"Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.
Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks"
75235|NCT01929681|B3|Baseline|Total|Total of all reporting groups
75236|NCT01929681|B2|Baseline|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment
Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75259|NCT01929460|P2|Participant Flow|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75238|NCT01929681|P2|Participant Flow|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment
Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75239|NCT01929681|P1|Participant Flow|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment
Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75240|NCT01929681|O2|Outcome|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment
Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75241|NCT01929681|O1|Outcome|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment
Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75242|NCT01929681|O2|Outcome|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment
Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75243|NCT01929681|O1|Outcome|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment
Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75244|NCT01929681|O2|Outcome|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment
Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75245|NCT01929681|O1|Outcome|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment
Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75246|NCT01929681|O2|Outcome|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment
Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75247|NCT01929681|O1|Outcome|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment
Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75248|NCT01929681|O2|Outcome|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment
Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75249|NCT01929681|O1|Outcome|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment
Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75250|NCT01929681|E2|Reported Event|LFMS - Sham Treatment|"Low Field Magnetic Stimulation - sham treatment
Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75399|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
75677|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75251|NCT01929681|E1|Reported Event|LFMS - Active Treatment|"Low Field Magnetic Stimulation (LFMS) active treatment
Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.
Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency."
75252|NCT01929473|B1|Baseline|Blood Drawings (0 Day, 365 Day) and Questionnaires|
75253|NCT01929473|P1|Participant Flow|Blood Drawings (0 Day, 365 Day) and Questionnaires|
75254|NCT01929473|O1|Outcome|Blood Drawings (0 Day, 365 Day) and Questionnaires|
75255|NCT01929473|E1|Reported Event|Blood Drawings (0 Day, 365 Day) and Questionnaires|
75256|NCT01929460|B3|Baseline|Total|Total of all reporting groups
75257|NCT01929460|B2|Baseline|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75258|NCT01929460|B1|Baseline|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75540|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
96170|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
75260|NCT01929460|P1|Participant Flow|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75261|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75262|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75263|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75264|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75265|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75266|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75267|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75268|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75269|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75270|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75271|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75272|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75273|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75274|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75275|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75276|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75277|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75278|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75279|NCT01929460|E2|Reported Event|Intervention Group|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)"
75280|NCT01929460|E1|Reported Event|Drug (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin"
75281|NCT01929317|B3|Baseline|Total|Total of all reporting groups
75678|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75282|NCT01929317|B2|Baseline|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75370|NCT01929083|P1|Participant Flow|Progesterone First, Then Placebo|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75371|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75372|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75283|NCT01929317|B1|Baseline|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75284|NCT01929317|P2|Participant Flow|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg per day administered orally OD for 4 weeks in the Screening phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
75285|NCT01929317|P1|Participant Flow|Ropinirole CR - High Dose Group|Participants received ropinirole controlled released (CR) 16 milligrams (mg) administered orally once daily (OD) for 4 weeks in the Screening Phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24 mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
75286|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75287|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75288|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75289|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
78372|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
75290|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75291|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75292|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75293|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75294|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75295|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75296|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75359|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.
Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
75527|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75297|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75298|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75299|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75300|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75301|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75302|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75303|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75360|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.
Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
75400|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
75304|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75305|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75306|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75307|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75308|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75309|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75310|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75361|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.
Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
75401|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
75311|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
96171|NCT01806857|O2|Outcome|Matching Placebo|
75312|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75313|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75314|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75315|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75316|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75317|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75362|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.
Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
75528|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75318|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75319|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75320|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75321|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75322|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75323|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75324|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75363|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.
Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
75402|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
75325|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75326|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75327|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75328|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75329|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75330|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75331|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75364|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.
Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
75403|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
75332|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75333|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75334|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75335|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75336|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75337|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75338|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75365|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.
Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
75404|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
75339|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
96172|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
75340|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75341|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75342|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75343|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75344|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75345|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75366|NCT01929135|E2|Reported Event|Placebo Group|"A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus placebo dentifrice.Therapy was supplemented with oral hygiene instruction, indicating patients to brush with dentifrice 2 times a day for two minutes each time, for 30 days.
Non medicated dentifrice: fluoride dentifrice."
75405|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
78373|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
75346|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75347|NCT01929317|E4|Reported Event|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75348|NCT01929317|E3|Reported Event|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75349|NCT01929317|E2|Reported Event|Ropinirole CR - Maintenance Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75350|NCT01929317|E1|Reported Event|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
75351|NCT01929135|B3|Baseline|Total|Total of all reporting groups
75352|NCT01929135|B2|Baseline|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
75353|NCT01929135|B1|Baseline|Atorvastatin Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days.
75354|NCT01929135|P2|Participant Flow|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
75355|NCT01929135|P1|Participant Flow|Atorvastatin Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days..
75356|NCT01929135|O2|Outcome|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
75357|NCT01929135|O1|Outcome|Atorvastatin Group|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.
Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
75358|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.
Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
75396|NCT01929044|P2|Participant Flow|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
75367|NCT01929135|E1|Reported Event|Atorvastatin Group|"A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus medicated 2% atorvastatin dentifrice. Therapy was supplemented with oral hygiene instruction, indicating patients to brush with the dentifrice 2 times a day for two minutes each time for a period of 30 days.
Atorvastatin dentifrice: fluoride dentifrice with 2% Atorvastatin (20 mg per ml)."
75368|NCT01929083|B1|Baseline|Entire Study Population|n=15 subjects who completed the study
75369|NCT01929083|P2|Participant Flow|Placebo First, Then Progesterone|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75373|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75374|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75375|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75376|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75377|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75378|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75379|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75380|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75381|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75382|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75383|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75384|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75385|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75386|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75387|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75388|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75389|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75390|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75391|NCT01929083|E2|Reported Event|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
75392|NCT01929083|E1|Reported Event|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
75393|NCT01929044|B3|Baseline|Total|Total of all reporting groups
75394|NCT01929044|B2|Baseline|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
75395|NCT01929044|B1|Baseline|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
75406|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
75407|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
75408|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
75409|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
75410|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
75411|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
75412|NCT01929044|E2|Reported Event|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
75631|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75413|NCT01929044|E1|Reported Event|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
75414|NCT01929031|B5|Baseline|Total|Total of all reporting groups
75415|NCT01929031|B4|Baseline|Ibuprofen/Caffeine Stage 1|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
75416|NCT01929031|B3|Baseline|Ibuprofen Stage 1|One Ibuprofen 400mg tablet after dental surgery
75417|NCT01929031|B2|Baseline|Caffeine Stage 1|One Caffeine 100mg tablet after dental surgery
75418|NCT01929031|B1|Baseline|Placebo Stage 1|One Placebo tablet after dental surgery
75419|NCT01929031|P6|Participant Flow|Placebo - Ibuprofen|Study stage 1: One Placebo tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
75420|NCT01929031|P5|Participant Flow|Placebo - Ibuprofen/Caffeine|Study stage 1: One Placebo tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100mg tablet, while awake, over 5 days
75421|NCT01929031|P4|Participant Flow|Caffeine - Ibuprofen|Study stage 1: One Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
75422|NCT01929031|P3|Participant Flow|Caffeine - Ibuprofen/Caffeine|Study stage 1: One Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100mg tablet, while awake, over 5 days
75423|NCT01929031|P2|Participant Flow|Ibuprofen - Ibuprofen|Study stage 1: One Ibuprofen 400mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
75424|NCT01929031|P1|Participant Flow|Ibuprofen/Caffeine - Ibuprofen/Caffeine|Study stage 1: One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen400mg/Caffeine 100mg tablet, while awake, over 5 days
75425|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
75426|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
75427|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
75428|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
75429|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
75430|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
75431|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
75432|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
75433|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
75434|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
75435|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
75436|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
75437|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
75438|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
75439|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
75440|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
75441|NCT01929031|E4|Reported Event|Ibuprofen/Caffeine|Ibuprofen 400mg / Caffeine 100mg tablet
75442|NCT01929031|E3|Reported Event|Ibuprofen|Ibuprofen 400mg tablet
75443|NCT01929031|E2|Reported Event|Caffeine|Caffeine 100mg tablet
75444|NCT01929031|E1|Reported Event|Placebo|Placebo tablet
75445|NCT01928940|B3|Baseline|Total|Total of all reporting groups
75446|NCT01928940|B2|Baseline|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75514|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75515|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75516|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75447|NCT01928940|B1|Baseline|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75448|NCT01928940|P2|Participant Flow|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75529|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75449|NCT01928940|P1|Participant Flow|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75450|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75451|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75452|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75453|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75454|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75455|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75456|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75517|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75518|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75519|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75457|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75458|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75530|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75459|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75460|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75461|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75462|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75463|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75464|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75465|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75466|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75520|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75521|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75522|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75523|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75467|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75531|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75532|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75533|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75468|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75469|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75470|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75471|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75472|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75473|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75474|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75475|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75524|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75525|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75526|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75676|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75534|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75535|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75536|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75537|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75476|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75477|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75478|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75479|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75480|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75481|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75482|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75483|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75484|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75485|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75486|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75487|NCT01928940|E2|Reported Event|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75488|NCT01928940|E1|Reported Event|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
75489|NCT01928927|B3|Baseline|Total|Total of all reporting groups
75490|NCT01928927|B2|Baseline|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75491|NCT01928927|B1|Baseline|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75492|NCT01928927|P2|Participant Flow|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.
Control"
75493|NCT01928927|P1|Participant Flow|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75494|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.
Control"
75495|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75496|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.
Control"
75497|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75498|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.
Control"
75499|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75500|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.
Control"
75501|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75502|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75503|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75504|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75505|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75506|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75507|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75508|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75509|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75510|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75511|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75512|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75513|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75541|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75542|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75543|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75544|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75545|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75546|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75547|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75548|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75549|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75550|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75551|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75552|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75553|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75554|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75555|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75556|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75557|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75558|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75559|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75560|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75561|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75562|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75563|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75564|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75565|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75566|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75567|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75568|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75569|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75570|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75571|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75572|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75573|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75574|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75575|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75576|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75577|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75578|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75579|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75580|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75581|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75582|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
96173|NCT01806857|O2|Outcome|Matching Placebo|
75583|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75584|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75585|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75586|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75587|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75588|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75589|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75590|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75591|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75592|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75593|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75594|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75595|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75596|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75597|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75598|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75599|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75600|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75601|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75602|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75603|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75604|NCT01928927|O2|Outcome|Arm B: No Study Drug|Participants received no study drug and followed the week 0-48 evaluation schedule.
75605|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75606|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75607|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75608|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.
Control"
75609|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75610|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and will follow week 0-48 evaluation schedule.
Control"
75611|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75612|NCT01928927|E2|Reported Event|Arm B: No Study Drug|"Participants received no study drug and will follow week 0-48 evaluation schedule.
Control"
75613|NCT01928927|E1|Reported Event|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
Telmisartan"
75614|NCT01928771|B4|Baseline|Total|Total of all reporting groups
75615|NCT01928771|B3|Baseline|Placebo|Placebo administered subcutaneously
75616|NCT01928771|B2|Baseline|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75617|NCT01928771|B1|Baseline|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75618|NCT01928771|P3|Participant Flow|Placebo|Placebo administered subcutaneously
75619|NCT01928771|P2|Participant Flow|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75620|NCT01928771|P1|Participant Flow|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75621|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75622|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75623|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75624|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75625|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75626|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75627|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75628|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75629|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75630|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75635|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75636|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75637|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75638|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75639|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75640|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75641|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75642|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75643|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75644|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75645|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75646|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75647|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75648|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75649|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75650|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75651|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75652|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75653|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75654|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75655|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75656|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75657|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75658|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75659|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75660|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75661|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75662|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75663|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75664|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75665|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75666|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75667|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75668|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75669|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75670|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75671|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75672|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75673|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75674|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75675|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75679|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75680|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75681|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75682|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75683|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75684|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75685|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75686|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75687|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75688|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75689|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75690|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
75691|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75692|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75693|NCT01928771|E3|Reported Event|Placebo|Placebo administered subcutaneously
75694|NCT01928771|E2|Reported Event|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
75695|NCT01928771|E1|Reported Event|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
75696|NCT01928693|B4|Baseline|Total|Total of all reporting groups
75697|NCT01928693|B3|Baseline|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75698|NCT01928693|B2|Baseline|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75699|NCT01928693|B1|Baseline|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75700|NCT01928693|P3|Participant Flow|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75701|NCT01928693|P2|Participant Flow|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75702|NCT01928693|P1|Participant Flow|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75703|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75704|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75705|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
78374|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
75706|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75707|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75708|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75709|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75785|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75786|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75710|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75711|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75712|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75713|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75714|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75715|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75716|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75717|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75769|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75770|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75771|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75718|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75719|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75720|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75721|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75722|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75723|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75724|NCT01928693|E3|Reported Event|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75725|NCT01928693|E2|Reported Event|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75726|NCT01928693|E1|Reported Event|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
75727|NCT01928680|B1|Baseline|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.
This is a single arm phase II clinical trial.
Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
75728|NCT01928680|P1|Participant Flow|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.
This is a single arm phase II clinical trial.
Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
75729|NCT01928680|O1|Outcome|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.
This is a single arm phase II clinical trial.
Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
75730|NCT01928680|E1|Reported Event|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.
This is a single arm phase II clinical trial.
Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
75772|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75773|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75774|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75731|NCT01928615|B1|Baseline|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75732|NCT01928615|P1|Participant Flow|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75787|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75788|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75789|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75790|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75733|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75734|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75735|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75736|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75737|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75738|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75739|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75740|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75775|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75776|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75741|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75742|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75791|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
79427|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
75743|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75744|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75745|NCT01928615|E1|Reported Event|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
75746|NCT01928472|B5|Baseline|TOTAL|Total of all reporting groups
75747|NCT01928472|B4|Baseline|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75748|NCT01928472|B3|Baseline|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75749|NCT01928472|B2|Baseline|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75750|NCT01928472|B1|Baseline|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75751|NCT01928472|P4|Participant Flow|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75752|NCT01928472|P3|Participant Flow|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75753|NCT01928472|P2|Participant Flow|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75754|NCT01928472|P1|Participant Flow|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75755|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75756|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75757|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75758|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75759|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75760|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75761|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75762|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75763|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75764|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75765|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75766|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75767|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75768|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
77045|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
75777|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75778|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75779|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75780|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75781|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75782|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75783|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75784|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75792|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75793|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75794|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75795|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75796|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75797|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75798|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75799|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75800|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75801|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75802|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75803|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75804|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75805|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75806|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75807|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75808|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75809|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75810|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75811|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75812|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75813|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75814|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
75815|NCT01928472|E5|Reported Event|TOTAL|Total of all reporting groups.
75816|NCT01928472|E4|Reported Event|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
75817|NCT01928472|E3|Reported Event|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75818|NCT01928472|E2|Reported Event|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75819|NCT01928472|E1|Reported Event|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
75820|NCT01928433|B4|Baseline|Total|Total of all reporting groups
75821|NCT01928433|B3|Baseline|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin placebo i.v. once daily
Finafloxacin placebo tablets (as four tablets) once daily
Ciprofloxacin 400 mg i.v. two times daily
Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
75822|NCT01928433|B2|Baseline|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75823|NCT01928433|B1|Baseline|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75824|NCT01928433|P3|Participant Flow|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin placebo i.v. once daily
Finafloxacin placebo tablets (as four tablets) once daily
Ciprofloxacin 400 mg i.v. two times daily
Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
75825|NCT01928433|P2|Participant Flow|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75826|NCT01928433|P1|Participant Flow|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75827|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin placebo i.v. once daily
Finafloxacin placebo tablets (as four tablets) once daily
Ciprofloxacin 400 mg i.v. two times daily
Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
75828|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75850|NCT01928381|P6|Participant Flow|Sequence 5|Sequence 5 - 1st AZD5213 + pregabalin, 2nd placebo, 3rd pregabalin
79428|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
75829|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75830|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin placebo i.v. once daily
Finafloxacin placebo tablets (as four tablets) once daily
Ciprofloxacin 400 mg i.v. two times daily
Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
75831|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75832|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75833|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin placebo i.v. once daily
Finafloxacin placebo tablets (as four tablets) once daily
Ciprofloxacin 400 mg i.v. two times daily
Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
75834|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75835|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75836|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin placebo i.v. once daily
Finafloxacin placebo tablets (as four tablets) once daily
Ciprofloxacin 400 mg i.v. two times daily
Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
75837|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75838|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75839|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Intervention:
Ciprofloxacin 400 mg i.v. twice daily and Finafloxacin placebo i.v. once daily Ciprofloxacin 500 mg oral twice daily and Finafloxacin placebo tablets once daily Ciprofloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin placebo i.v. once daily: Infused over 60 mins [i.v. pump]) for at least 3 days.
Finafloxacin placebo tablets once daily: Administered as four tablets
Ciprofloxacin 400 mg i.v. twice daily: Infused over approximately 60 mins [i.v. pump]) for at least 3 days
Ciprofloxacin 500 mg oral twice daily: Administered as two 250 mg capsules."
75840|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Intervention:
Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 10 days.
Finafloxacin 800 mg i.v. once daily: Infused over 60 mins [i.v. pump]) for at least 3 days.
Finafloxacin 800 mg tablets once daily: Administered as four 200 mg tablets
Ciprofloxacin placebo i.v. twice daily: Infused over approximately 60 mins [i.v. pump]) for at least 3 days
Ciprofloxacin placebo oral twice daily: Administered as two capsules."
75841|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Intervention:
Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 5 days.
Finafloxacin 800 mg i.v. once daily: Infused over 60 mins [i.v. pump]) for at least 3 days.
Finafloxacin 800 mg tablets once daily: Administered as four 200 mg tablets
Ciprofloxacin placebo i.v. twice daily: Infused over approximately 60 mins [i.v. pump]) for at least 3 days
Ciprofloxacin placebo oral twice daily: Administered as two capsules."
75905|NCT01927575|E2|Reported Event|Standard CT|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.
Standard X-Ray: Standard of Care X-Ray Imaging
Followed by Tomo imaging
No AE's during X-ray, CT or Tomo."
75842|NCT01928433|O3|Outcome|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin placebo i.v. once daily
Finafloxacin placebo tablets (as four tablets) once daily
Ciprofloxacin 400 mg i.v. two times daily
Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
75843|NCT01928433|O2|Outcome|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75844|NCT01928433|O1|Outcome|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75845|NCT01928433|E3|Reported Event|Ciprofloxacin 10 Days|"Ciprofloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin placebo i.v. once daily
Finafloxacin placebo tablets (as four tablets) once daily
Ciprofloxacin 400 mg i.v. two times daily
Ciprofloxacin 500 mg oral (as two 250 mg capsules) two times daily"
75846|NCT01928433|E2|Reported Event|Finafloxacin 10 Days|"Finafloxacin (i.v. and oral) for a total of 10 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75847|NCT01928433|E1|Reported Event|Finafloxacin 5 Days|"Finafloxacin (i.v. and oral) for a total of 5 days.
Finafloxacin 800 mg i.v. once daily
Finafloxacin 800 mg tablets (as four 200 mg tablets) once daily
Ciprofloxacin placebo i.v. two times daily
Ciprofloxacin placebo oral (as two capsules each) two times daily"
75848|NCT01928381|B1|Baseline|Overall Study|Overall Study - Starting with Part 1
75849|NCT01928381|P7|Participant Flow|Sequence 6|Sequence 6 - 1st AZD5213 + pregabalin, 2nd pregabalin, 3rd placebo
96174|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
75851|NCT01928381|P5|Participant Flow|Sequence 4|Sequence 4 - 1st pregabalin, 2nd AZD5213 + pregabalin, 3rd placebo
75852|NCT01928381|P4|Participant Flow|Sequence 3|Sequence 3 - 1st pregabalin, 2nd placebo, 3rd AZD5213 + pregabalin
75853|NCT01928381|P3|Participant Flow|Sequence 2|Sequence 2 - 1st Placebo, 2nd AZD5213 + pregabalin, 3rd pregabalin
75854|NCT01928381|P2|Participant Flow|Sequence 1|Sequence 1 - 1st placebo, 2nd pregabalin, 3rd AZD5213 + pregabalin
75855|NCT01928381|P1|Participant Flow|Part 1 - Pain Training|Part 1 - Screening, Pain Training, placebo run-in eligibility for Part 2
75856|NCT01928381|O3|Outcome|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
75857|NCT01928381|O2|Outcome|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
75858|NCT01928381|O1|Outcome|Part 2 - Placebo|Part 2 - placebo crossover periods
75859|NCT01928381|O3|Outcome|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
75860|NCT01928381|O2|Outcome|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
75861|NCT01928381|O1|Outcome|Part 2 - Placebo|Part 2 - placebo crossover periods
75862|NCT01928381|E5|Reported Event|Overall Study|Overall Study: Part 1 and Part 2
75863|NCT01928381|E4|Reported Event|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
75864|NCT01928381|E3|Reported Event|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
75865|NCT01928381|E2|Reported Event|Part 2 - Placebo|Part 2 - placebo crossover periods
75866|NCT01928381|E1|Reported Event|Part 1|Part 1 - Pain training + 1 week of single blind placebo
75867|NCT01928030|B1|Baseline|Hyaluronidase, Recombinant Human|Patients receive recombinant human hyaluronidase 450 units or 900 units SC on days 1, 3, 5, and 7 (Phase 1) and then on days 1 to 21 (Phase 2) in the absence of disease progression or unacceptable toxicity.
75868|NCT01928030|P3|Participant Flow|MTD rHuPH20 (Days 1 to 21)|Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
75869|NCT01928030|P2|Participant Flow|900 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
75870|NCT01928030|P1|Participant Flow|450 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 450 units rHuPH20 SC on days 1, 3, 5, and 7
75871|NCT01928030|O3|Outcome|MTD rHuPH20 (Days 1 to 21)|Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
75872|NCT01928030|O2|Outcome|900 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
75873|NCT01928030|O1|Outcome|450 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 450 units rHuPH20 SC on days 1, 3, 5, and 7
75874|NCT01928030|O1|Outcome|450 Units Recombinant Human Hyaluronidase (rHuPH20)|Participants receive 450 units recombinant human hyaluronidase (rHuPH20) subcutaneously (SC) on Days 1, 3, 5, and 7 (Phase 1) and then on Days 1 to 21 (Phase 2) in the absence of disease progression or unacceptable toxicity.
75875|NCT01928030|E1|Reported Event|Recombinant Human Hyaluronidase|"Participants who received 450 units recombinant human hyaluronidase (rHuPH20) subcutaneously in Phase 1 were assessed in this outcome measure, treatment-related adverse events.
Biomarker analysis and pharmacology study were performed during study.
recombinant human hyaluronidase: Given subcutaneously"
75876|NCT01927887|B1|Baseline|Nanoparticle Enhanced MRI|"Each subject will have one MRI scan at MGH. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed.The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.
Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.
lymphotrophic superparamagnetic nanoparticle"
75906|NCT01927575|E1|Reported Event|Standard X-Ray|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.
Standard X-Ray: Standard of Care X-Ray Imaging
Followed by Tomo imaging
No AE's during X-ray, CT or Tomo."
75907|NCT01927419|B3|Baseline|Total|Total of all reporting groups
78375|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks
75877|NCT01927887|P1|Participant Flow|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols.Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec.
75878|NCT01927887|O1|Outcome|Nanoparticle MRI|Nanoparticle MRI: Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.
75879|NCT01927887|O1|Outcome|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|"Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.
Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.
lymphotrophic superparamagnetic nanoparticle"
75940|NCT01927120|E1|Reported Event|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75941|NCT01927055|B4|Baseline|Total|Total of all reporting groups
75880|NCT01927887|E1|Reported Event|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|"Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.
Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.
lymphotrophic superparamagnetic nanoparticle"
75881|NCT01927757|B1|Baseline|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75882|NCT01927757|P1|Participant Flow|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75883|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75884|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75885|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75886|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75887|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75888|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75889|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75890|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75891|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75892|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75893|NCT01927757|O2|Outcome|Secondary Failure|Participants who lost a satisfactory response (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 6 months.
75894|NCT01927757|O1|Outcome|Primary Failure|Participants failed to respond (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 3 months.
75895|NCT01927757|O2|Outcome|Absence of Anti-adalimumab Antibodies|Participants with absence of anti-adalimumab antibodies.
75896|NCT01927757|O1|Outcome|Presence of Anti-adalimumab Antibodies|Participants with anti-adalimumab antibodies.
75897|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75898|NCT01927757|E1|Reported Event|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
75899|NCT01927575|B1|Baseline|All Study Participants|"Standard X-Ray + CT arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis.
Standard X-Ray + CT: Standard of Care X-Ray Imaging + CT
Followed by Tomo Imaging"
75900|NCT01927575|P1|Participant Flow|All Study Participants|"Standard of care X-Ray imaging plus CT to be compared with research imaging device.
Standard X-Ray: Standard of Care X-Ray Imaging + CT
Followed by Tomo Imaging"
75901|NCT01927575|O3|Outcome|Tomosynthesis|"Tomosynthesis imaging to be compared to standard of care CT and X-ray
No AEs"
75902|NCT01927575|O2|Outcome|Standard CT|"Standard of care CT imaging to be compared with research imaging device.
Followed by Tomo imaging
No AE's"
75903|NCT01927575|O1|Outcome|Standard X-Ray|"Standard of care X-Ray imaging to be compared with research imaging device.
Followed by Tomo imaging
No AE's"
75904|NCT01927575|E3|Reported Event|Tomo|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.
Standard X-Ray: Standard of Care X-Ray Imaging
Followed by Tomo imaging
No AE's during X-ray, CT or Tomo."
76457|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
75908|NCT01927419|B2|Baseline|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75909|NCT01927419|B1|Baseline|Nivolumab + Ipilimumab|Participants received (Part) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75910|NCT01927419|P2|Participant Flow|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75911|NCT01927419|P1|Participant Flow|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75912|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
76419|NCT01924767|P3|Participant Flow|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
75913|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75914|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75915|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) until documented disease progression, toxicity, withdrawal of consent, or study completion.
75916|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75917|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75918|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75919|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75920|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75921|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75922|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75923|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75924|NCT01927419|E2|Reported Event|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75925|NCT01927419|E1|Reported Event|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
75926|NCT01927120|B1|Baseline|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75927|NCT01927120|P1|Participant Flow|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75928|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75929|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75930|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75931|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75932|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75933|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75934|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75935|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75936|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75937|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75938|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75939|NCT01927120|O1|Outcome|GVHD Regimen|Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
75942|NCT01927055|B3|Baseline|Placebo|"Placebo
Placebo: Placebo to match droxidopa capsules and strength designations. 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
75943|NCT01927055|B2|Baseline|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg
Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
75944|NCT01927055|B1|Baseline|Open-Label|Patients entered open label droxidopa dose titration, but did not proceed into the randomization phase.
75945|NCT01927055|P3|Participant Flow|Placebo|"Placebo
Placebo: Placebo to match droxidopa capsules and strength designations"
75946|NCT01927055|P2|Participant Flow|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg
Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
75947|NCT01927055|P1|Participant Flow|Open-label Titration|"Droxidopa 100 mg, 200 mg
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 2 weeks of treatment"
75948|NCT01927055|O2|Outcome|Placebo|"Placebo
Placebo: Placebo to match droxidopa capsules and strength designations"
75949|NCT01927055|O1|Outcome|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg
Droxidopa: Droxidopa at 100 mg, 200 mg, 300 mg"
75950|NCT01927055|E3|Reported Event|Placebo|"Placebo
Placebo: Placebo to match droxidopa capsules and strength designations"
75951|NCT01927055|E2|Reported Event|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg
Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
75952|NCT01927055|E1|Reported Event|Open-label Titration|All patients treated with study drug during dose titration (1-14 days)
75953|NCT01926977|B3|Baseline|Total|Total of all reporting groups
75954|NCT01926977|B2|Baseline|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
75955|NCT01926977|B1|Baseline|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once
Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
75956|NCT01926977|P2|Participant Flow|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
75957|NCT01926977|P1|Participant Flow|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once
Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
75958|NCT01926977|O2|Outcome|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
75959|NCT01926977|O1|Outcome|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once
Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
75960|NCT01926977|O2|Outcome|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
75961|NCT01926977|O1|Outcome|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once
Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
75962|NCT01926977|E2|Reported Event|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
75963|NCT01926977|E1|Reported Event|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once
Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
75964|NCT01926782|B7|Baseline|Total|Total of all reporting groups
75965|NCT01926782|B6|Baseline|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75966|NCT01926782|B5|Baseline|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75967|NCT01926782|B4|Baseline|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
75968|NCT01926782|B3|Baseline|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75969|NCT01926782|B2|Baseline|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75970|NCT01926782|B1|Baseline|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
75971|NCT01926782|P6|Participant Flow|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75972|NCT01926782|P5|Participant Flow|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76420|NCT01924767|P2|Participant Flow|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
75973|NCT01926782|P4|Participant Flow|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
75974|NCT01926782|P3|Participant Flow|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75975|NCT01926782|P2|Participant Flow|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75976|NCT01926782|P1|Participant Flow|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
75977|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75978|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
75979|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
75980|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75981|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
75982|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
75983|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75984|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
75985|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
75986|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75987|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
75988|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
75989|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75990|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
75991|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
75992|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76339|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
75993|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
75994|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
75995|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75996|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
75997|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
75998|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
75999|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76000|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76001|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76002|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76003|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76004|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76005|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76006|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76007|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76048|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76008|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76009|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76010|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76011|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76012|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
96175|NCT01806857|O2|Outcome|Matching Placebo|
76013|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76014|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76015|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76016|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76017|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76018|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76019|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76020|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76021|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76022|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76023|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76024|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76025|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76026|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76027|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76069|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76028|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76029|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76030|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76031|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76340|NCT01925209|E4|Reported Event|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76032|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76033|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76034|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76035|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76036|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76037|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76038|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76039|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76040|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76041|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76042|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76043|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76044|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8"
76045|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76046|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76047|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76049|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76050|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76051|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76052|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76053|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76054|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76055|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76056|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76057|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76058|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76059|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76060|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76061|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76062|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76063|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76064|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8
76065|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76066|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76067|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76068|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76070|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8
76071|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76072|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76073|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76074|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76075|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76076|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76077|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76078|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76079|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76080|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76081|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76082|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76083|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76084|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76085|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76086|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76087|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76088|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76089|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76090|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76091|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76092|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76093|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76146|NCT01926015|B1|Baseline|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76094|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76095|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8"
76096|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76097|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76098|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76099|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76100|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8
76101|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76102|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76103|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76104|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76105|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76106|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76107|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76108|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76109|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76142|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.
Transcranial Magnetic Stimulation"
76110|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76111|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76112|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76341|NCT01925209|E3|Reported Event|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76113|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76114|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76115|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76116|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76117|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
76118|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76119|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels
≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
76120|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
76121|NCT01926782|E3|Reported Event|Alirocumab 300 mg Q4W/Up 150 mg Q2W|Two SC injections of Alirocumab 300 mg Q4W alternating with two SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76122|NCT01926782|E2|Reported Event|Alirocumab 75 mg Q2W/Up 150 mg Q2W|One SC injection of Alirocumab 150 mg Q4W alternating with 2 SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
76123|NCT01926782|E1|Reported Event|Placebo Q2W|Two SC injections of placebo (for alirocumab) Q2W with or without stable statin therapy for 48 weeks.
76124|NCT01926626|B1|Baseline|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
76125|NCT01926626|P1|Participant Flow|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
76126|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
76127|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
76170|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76128|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
76129|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
76130|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
76131|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
76132|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
76133|NCT01926626|E1|Reported Event|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
76134|NCT01926119|B1|Baseline|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation
Transcranial Magnetic Stimulation"
76135|NCT01926119|P1|Participant Flow|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation
Transcranial Magnetic Stimulation"
76136|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.
Transcranial Magnetic Stimulation"
76137|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.
Transcranial Magnetic Stimulation"
76138|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.
Transcranial Magnetic Stimulation"
76139|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.
Transcranial Magnetic Stimulation"
76140|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.
Transcranial Magnetic Stimulation"
76141|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.
Transcranial Magnetic Stimulation"
76143|NCT01926119|E1|Reported Event|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation
Transcranial Magnetic Stimulation"
76144|NCT01926015|B3|Baseline|Total|Total of all reporting groups
76145|NCT01926015|B2|Baseline|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76197|NCT01925768|E2|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast BID during the 24 week placebo controlled period.
76147|NCT01926015|P2|Participant Flow|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76148|NCT01926015|P1|Participant Flow|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76149|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76150|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76151|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76152|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76153|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76154|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76155|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76156|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76157|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76158|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76159|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76160|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76161|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76162|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76163|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76164|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76165|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76166|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76167|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76168|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76169|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76171|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76172|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76173|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76174|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76175|NCT01926015|E2|Reported Event|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76176|NCT01926015|E1|Reported Event|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
76177|NCT01925781|B3|Baseline|Total|Total of all reporting groups
76178|NCT01925781|B2|Baseline|Nicotine Polacrilex|"Nicotine Replacement gum
Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
76179|NCT01925781|B1|Baseline|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
76180|NCT01925781|P2|Participant Flow|Nicotine Polacrilex|"Nicotine Replacement gum
Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
76181|NCT01925781|P1|Participant Flow|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
76182|NCT01925781|O2|Outcome|Nicotine Polacrilex|"Nicotine Replacement gum
Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
76183|NCT01925781|O1|Outcome|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
76184|NCT01925781|O2|Outcome|Nicotine Polacrilex|"Nicotine Replacement gum
Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
76185|NCT01925781|O1|Outcome|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
76186|NCT01925781|E2|Reported Event|Nicotine Polacrilex|"Nicotine Replacement gum
Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
76187|NCT01925781|E1|Reported Event|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
76188|NCT01925768|B3|Baseline|Total|Total of all reporting groups
76189|NCT01925768|B2|Baseline|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
76190|NCT01925768|B1|Baseline|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
76191|NCT01925768|P2|Participant Flow|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
76192|NCT01925768|P1|Participant Flow|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
76193|NCT01925768|O2|Outcome|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
76331|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
77386|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks"
76194|NCT01925768|O1|Outcome|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
76195|NCT01925768|O2|Outcome|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
76196|NCT01925768|O1|Outcome|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
76198|NCT01925768|E1|Reported Event|Week 24: Placebo|Participants randomized to receive placebo tablets twice daily (BID) during the placebo-controlled phase. Includes data through week 16 for participants who early escaped and through week 24 for all other participants.
76199|NCT01925703|B1|Baseline|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
76200|NCT01925703|P1|Participant Flow|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
76201|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
76202|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
76203|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
76204|NCT01925703|E1|Reported Event|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
76205|NCT01925469|B3|Baseline|Total|Total of all reporting groups
76206|NCT01925469|B2|Baseline|Saline Spray|"A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group"
76207|NCT01925469|B1|Baseline|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine"
76208|NCT01925469|P2|Participant Flow|Saline Spray|"A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group"
76209|NCT01925469|P1|Participant Flow|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine"
76210|NCT01925469|O2|Outcome|Saline Spray|"A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group"
76211|NCT01925469|O1|Outcome|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine"
76212|NCT01925469|O2|Outcome|Saline Spray|"A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group"
76213|NCT01925469|O1|Outcome|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine"
76214|NCT01925469|O2|Outcome|Saline Spray|"A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group"
76215|NCT01925469|O1|Outcome|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine"
76216|NCT01925469|E2|Reported Event|Saline Spray|"A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group"
76217|NCT01925469|E1|Reported Event|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine"
76218|NCT01925417|B1|Baseline|RBX2660 (Microbiota Suspension)|Open-label; all subjects received RBX2660
76219|NCT01925417|P1|Participant Flow|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
76220|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
76221|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
76222|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
76223|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
76224|NCT01925417|E1|Reported Event|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
76225|NCT01925274|B4|Baseline|Total|Total of all reporting groups
76332|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76458|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76226|NCT01925274|B3|Baseline|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76227|NCT01925274|B2|Baseline|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76335|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
76336|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76228|NCT01925274|B1|Baseline|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76229|NCT01925274|P3|Participant Flow|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76230|NCT01925274|P2|Participant Flow|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76231|NCT01925274|P1|Participant Flow|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76232|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76233|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76234|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76235|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76236|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76289|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76237|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76238|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76239|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76240|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76241|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76242|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76243|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76244|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76245|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76246|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76301|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
77387|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks"
76247|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76421|NCT01924767|P1|Participant Flow|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
76248|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76249|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76250|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76251|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76252|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76253|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76254|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76255|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76256|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76327|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
76257|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
96176|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
76258|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76259|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76260|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76261|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76262|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76263|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76264|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76265|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76266|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76328|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
77388|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks
Placebo: BID up to 4 weeks"
76267|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76268|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76269|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76270|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76271|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76272|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76273|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76274|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76275|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76276|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76277|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76329|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
77389|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks"
76278|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76279|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76280|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76281|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76282|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76283|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76284|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76285|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76286|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76287|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76288|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76330|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
77390|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks"
76290|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76291|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76292|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76293|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76294|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76295|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76296|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76297|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76298|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76299|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76300|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76456|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76302|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76337|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76338|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76303|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76304|NCT01925274|E3|Reported Event|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28 day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF 05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76305|NCT01925274|E2|Reported Event|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
76306|NCT01925274|E1|Reported Event|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
76307|NCT01925209|B5|Baseline|Total|Total of all reporting groups
76308|NCT01925209|B4|Baseline|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76309|NCT01925209|B3|Baseline|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76310|NCT01925209|B2|Baseline|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76311|NCT01925209|B1|Baseline|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
76312|NCT01925209|P4|Participant Flow|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76313|NCT01925209|P3|Participant Flow|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76314|NCT01925209|P2|Participant Flow|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76315|NCT01925209|P1|Participant Flow|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
76316|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76317|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76318|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76319|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
76320|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76321|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76322|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76323|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
76324|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76325|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76326|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
77391|NCT01920802|E3|Reported Event|Placebo|"BID placebo up to 4 weeks
Placebo: BID up to 4 weeks"
76333|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76334|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76342|NCT01925209|E2|Reported Event|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
76343|NCT01925209|E1|Reported Event|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
76344|NCT01925183|B3|Baseline|Total|Total of all reporting groups
76345|NCT01925183|B2|Baseline|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
76346|NCT01925183|B1|Baseline|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
76347|NCT01925183|P2|Participant Flow|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
76348|NCT01925183|P1|Participant Flow|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of pegylated interferon/ribavirin (PEGIFN/RBV) lead-in. Patients with undetectable hepatitis C virus (HCV)-RNA at treatment week 8 will be treated with 24 weeks of boceprevir (BOC)/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
76349|NCT01925183|O2|Outcome|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
76350|NCT01925183|O1|Outcome|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
76351|NCT01925183|O2|Outcome|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
76352|NCT01925183|O1|Outcome|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
76353|NCT01925183|E2|Reported Event|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
76354|NCT01925183|E1|Reported Event|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection
Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
76385|NCT01924975|B2|Baseline|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.
Saphenous vein cannulation: Intravenous cannulation to saphenous vein
ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein
A 22 or 24 G intravenous catheter"
76422|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76355|NCT01925170|B1|Baseline|Mammography and Molecular Breast Imaging|"Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.
Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands."
76356|NCT01925170|P1|Participant Flow|Mammography and Molecular Breast Imaging|"Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.
Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands."
76357|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
76358|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
76359|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
76360|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
76361|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
76362|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
76363|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
76364|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
76365|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
76366|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
76367|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
76368|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
76369|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
76370|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
76371|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
76372|NCT01925170|E1|Reported Event|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
76373|NCT01925144|B1|Baseline|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2.
40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
76374|NCT01925144|P1|Participant Flow|Baricitinib + Omeprazole|"10 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2.
40 mg omeprazole capsule administered orally, once daily (QD), for 8 days (Days 3 through 10) in Period 2."
76375|NCT01925144|O2|Outcome|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.
40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
76376|NCT01925144|O1|Outcome|Baricitinib|10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
76377|NCT01925144|O2|Outcome|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.
40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
76378|NCT01925144|O1|Outcome|Baricitinib|10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
76379|NCT01925144|O2|Outcome|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.
40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
76380|NCT01925144|O1|Outcome|Baricitinib|10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
76381|NCT01925144|E3|Reported Event|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally once with 40 mg omeprazole capsule orally once, on Day 10 in Period 2.
Adverse events are reported from postdose on Day 10 up to Day 24."
76382|NCT01925144|E2|Reported Event|Omeprazole|"40 mg omeprazole capsule administered orally, QD, on Days 3 through 9 in Period 2.
Adverse events are reported from postdose on Day 3 through predose on Day 10."
76383|NCT01925144|E1|Reported Event|Baricitinib|"10 mg baricitinib tablet administered orally once, on Day 1 in Period 1.
Adverse events are reported from baseline through predose on Day 3."
76384|NCT01924975|B3|Baseline|Total|Total of all reporting groups
76386|NCT01924975|B1|Baseline|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.
Saphenous vein cannulation: Intravenous cannulation to saphenous vein
A 22 or 24 G intravenous catheter"
76387|NCT01924975|P2|Participant Flow|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.
Saphenous vein cannulation: Intravenous cannulation to saphenous vein
ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein
A 22 or 24 G intravenous catheter"
76388|NCT01924975|P1|Participant Flow|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.
Saphenous vein cannulation: Intravenous cannulation to saphenous vein
A 22 or 24 G intravenous catheter"
76389|NCT01924975|O2|Outcome|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.
Saphenous vein cannulation: Intravenous cannulation to saphenous vein
ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein
A 22 or 24 G intravenous catheter"
76390|NCT01924975|O1|Outcome|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.
Saphenous vein cannulation: Intravenous cannulation to saphenous vein
A 22 or 24 G intravenous catheter"
76391|NCT01924975|E2|Reported Event|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.
Saphenous vein cannulation: Intravenous cannulation to saphenous vein
ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein
A 22 or 24 G intravenous catheter"
76392|NCT01924975|E1|Reported Event|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.
Saphenous vein cannulation: Intravenous cannulation to saphenous vein
A 22 or 24 G intravenous catheter"
76393|NCT01924949|B1|Baseline|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
76394|NCT01924949|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
76395|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
76396|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
76397|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
76398|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
76399|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
76400|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
76401|NCT01924949|E1|Reported Event|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
76402|NCT01924871|B3|Baseline|Total|Total of all reporting groups
76403|NCT01924871|B2|Baseline|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil
Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
76404|NCT01924871|B1|Baseline|Desflurane Group|"1.5 MAC desflurane until extubation
Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
76405|NCT01924871|P2|Participant Flow|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil
Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
76406|NCT01924871|P1|Participant Flow|Desflurane Group|"1.5 MAC desflurane until extubation
Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
76407|NCT01924871|O2|Outcome|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil
Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
76408|NCT01924871|O1|Outcome|Desflurane Group|"1.5 MAC desflurane until extubation
Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
76409|NCT01924871|E2|Reported Event|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil
Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
76410|NCT01924871|E1|Reported Event|Desflurane Group|"1.5 MAC desflurane until extubation
Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
76411|NCT01924767|B6|Baseline|Total|Total of all reporting groups
76412|NCT01924767|B5|Baseline|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.
76413|NCT01924767|B4|Baseline|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.
76414|NCT01924767|B3|Baseline|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.
76415|NCT01924767|B2|Baseline|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.
76416|NCT01924767|B1|Baseline|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
76417|NCT01924767|P5|Participant Flow|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76418|NCT01924767|P4|Participant Flow|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76423|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76424|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76425|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76426|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
76427|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76428|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76429|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76430|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76431|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
76432|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76433|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76434|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76435|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76436|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
76437|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76438|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76439|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76440|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76441|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
76442|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76443|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76444|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76445|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76446|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
76447|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76448|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76449|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76450|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76451|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76452|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76453|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76454|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76455|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76459|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76460|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76461|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76462|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76463|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76464|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76465|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76466|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76467|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76468|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76469|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76470|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76471|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76472|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76473|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76474|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76475|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76476|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76477|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76478|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76479|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76480|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76481|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76482|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76483|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76484|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76485|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76486|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76487|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76488|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76489|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76490|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76491|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76492|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76493|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76494|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76495|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76496|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76497|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76498|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76499|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
76500|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76501|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76502|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76503|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76504|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
76505|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
78376|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
76506|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76507|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76508|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76509|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
76510|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
76511|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
76512|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
76513|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
76514|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
76515|NCT01924767|E5|Reported Event|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.
76516|NCT01924767|E4|Reported Event|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.
76517|NCT01924767|E3|Reported Event|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.
76518|NCT01924767|E2|Reported Event|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.
76519|NCT01924767|E1|Reported Event|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
76520|NCT01924559|B1|Baseline|SALT and Biohazard Gear|All participants were tested on three intubation devices in either standard clothing or biohazard gear.
76521|NCT01924559|P1|Participant Flow|All Study Participants|All participants were randomized into groups testing three intubation devices while wearing standard clothing or biohazard gear..
76522|NCT01924559|O6|Outcome|SALT and Biohazard Gear|"Residents will intubate manikins using SALT while wearing biohazard gear.
Biohazard gear
SALT"
76523|NCT01924559|O5|Outcome|SALT & Standard Clothing|"Residents will intubate manikins using SALT while wearing standard clothing.
standard clothing
SALT"
76524|NCT01924559|O4|Outcome|Glidescope & Biohazard Gear|"Residents will intubate manikins using Glidescope while wearing Biohazard gear.
Biohazard gear
Glidescope"
76525|NCT01924559|O3|Outcome|Glidescope & Standard Clothing|"Residents will intubate manikins using Glidescope while wearing standard clothing.
standard clothing
Glidescope"
76526|NCT01924559|O2|Outcome|DL & Biohazard Gear|"Residents will intubate manikins using DL while in Biohazard gear.
Biohazard gear
DL"
76527|NCT01924559|O1|Outcome|DL & Standard Clothing|"Residents will intubate manikin using DL while wearing standard clothing.
standard clothing
DL"
76528|NCT01924559|E6|Reported Event|SALT and Biohazard Gear|"Residents will intubate manikins using SALT while wearing biohazard gear.
Biohazard gear
SALT No adverse events"
76529|NCT01924559|E5|Reported Event|SALT & Standard Clothing|"Residents will intubate manikins using SALT while wearing standard clothing.
standard clothing
SALT"
76530|NCT01924559|E4|Reported Event|Glidescope & Biohazard Gear|"Residents will intubate manikins using Glidescope while wearing Biohazard gear.
Biohazard gear
GlideScope"
76531|NCT01924559|E3|Reported Event|Glidescope & Standard Clothing|"Residents will intubate manikins using Glidescope while wearing standard clothing.
standard clothing
GlideScope"
76532|NCT01924559|E2|Reported Event|DL & Biohazard Gear|"Residents will intubate manikins using DL while in Biohazard gear.
Biohazard gear
DL"
76533|NCT01924559|E1|Reported Event|DL & Standard Clothing|"Residents will intubate manikin using DL while wearing standard clothing.
standard clothing
DL"
76534|NCT01924390|B3|Baseline|Total|Total of all reporting groups
76535|NCT01924390|B2|Baseline|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone
Combination of Mineralized and demineralized freeze-dried bone allograft alone"
76536|NCT01924390|B1|Baseline|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone
Mineralized freeze-dried bone allograft alone"
76537|NCT01924390|P2|Participant Flow|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone
Combination of Mineralized and demineralized freeze-dried bone allograft alone"
76538|NCT01924390|P1|Participant Flow|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone
Mineralized freeze-dried bone allograft alone"
76539|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone
Combination of Mineralized and demineralized freeze-dried bone allograft alone"
76540|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone
Mineralized freeze-dried bone allograft alone"
76541|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone
Combination of Mineralized and demineralized freeze-dried bone allograft alone"
76542|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone
Mineralized freeze-dried bone allograft alone"
76543|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone
Combination of Mineralized and demineralized freeze-dried bone allograft alone"
76544|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone
Mineralized freeze-dried bone allograft alone"
76545|NCT01924390|E2|Reported Event|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone
Combination of Mineralized and demineralized freeze-dried bone allograft alone"
76546|NCT01924390|E1|Reported Event|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone
Mineralized freeze-dried bone allograft alone"
76547|NCT01924299|B3|Baseline|Total|Total of all reporting groups
76548|NCT01924299|B2|Baseline|Baricitinib + Fluconazole (Group B)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.
400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2."
76549|NCT01924299|B1|Baseline|Baricitinib + Ketoconazole (Group A)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.
400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2."
76550|NCT01924299|P2|Participant Flow|Baricitinib + Fluconazole (Group B)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.
400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2."
76551|NCT01924299|P1|Participant Flow|Baricitinib + Ketoconazole (Group A)|"10 milligrams (mg) baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.
400 mg ketoconazole administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2."
76552|NCT01924299|O2|Outcome|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
76553|NCT01924299|O1|Outcome|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1.
76554|NCT01924299|O2|Outcome|Baricitinib + Ketoconazole (Group A)|10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
76555|NCT01924299|O1|Outcome|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1.
76556|NCT01924299|O2|Outcome|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
76557|NCT01924299|O1|Outcome|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1.
76558|NCT01924299|O2|Outcome|Baricitinib + Ketoconazole (Group A)|10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
76559|NCT01924299|O1|Outcome|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1.
76560|NCT01924299|O2|Outcome|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
76561|NCT01924299|O1|Outcome|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1.
76562|NCT01924299|O2|Outcome|Baricitinib + Ketoconazole (Group A)|10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
76563|NCT01924299|O1|Outcome|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1.
76564|NCT01924299|E6|Reported Event|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 200 mg fluconazole administered orally QD on Day 7 through Day 9 in Period 2. Adverse events are reported from postdose on Day 7 up to Day 23.
76565|NCT01924299|E5|Reported Event|Fluconazole (Group B)|"400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD on Day 4 through Day 6 in Period 2.
Adverse events are reported from postdose on Day 3 through predose on Day 7."
76566|NCT01924299|E4|Reported Event|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3.
76567|NCT01924299|E3|Reported Event|Baricitinib + Ketoconazole (Group A)|"10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg ketoconazole administered orally QD on Day 6 through Day 8 in Period 2.
Adverse events are reported from postdose on Day 6 up to Day 22."
76568|NCT01924299|E2|Reported Event|Ketoconazole (Group A)|400 mg ketoconazole administered orally QD on Day 3 through Day 5 in Period 2. Adverse events are reported from postdose on Day 3 through predose on Day 6.
76569|NCT01924299|E1|Reported Event|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3.
76570|NCT01924182|B3|Baseline|Total|Total of all reporting groups
76571|NCT01924182|B2|Baseline|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
76572|NCT01924182|B1|Baseline|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.
SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
76573|NCT01924182|P2|Participant Flow|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
76574|NCT01924182|P1|Participant Flow|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.
SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
76791|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76575|NCT01924182|O2|Outcome|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
76576|NCT01924182|O1|Outcome|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.
SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
76577|NCT01924182|E2|Reported Event|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
76578|NCT01924182|E1|Reported Event|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.
SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
76579|NCT01923896|B3|Baseline|Total|Total of all reporting groups
76580|NCT01923896|B2|Baseline|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
76581|NCT01923896|B1|Baseline|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
76582|NCT01923896|P2|Participant Flow|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
76583|NCT01923896|P1|Participant Flow|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
76584|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
76585|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
76586|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
76587|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
76588|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
76589|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
76590|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
76591|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
76592|NCT01923896|E2|Reported Event|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
76593|NCT01923896|E1|Reported Event|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
76594|NCT01923805|B3|Baseline|Total|Total of all reporting groups
76595|NCT01923805|B2|Baseline|Control|Standard of care for surgical hemostasis.
76596|NCT01923805|B1|Baseline|Treatment Group|"Vitagel
Vitagel: Vitagel"
76597|NCT01923805|P2|Participant Flow|Control|Standard of care for surgical hemostasis.
76598|NCT01923805|P1|Participant Flow|Treatment Group|"Vitagel
Vitagel: Vitagel"
76599|NCT01923805|O2|Outcome|Control|Standard of care for surgical hemostasis.
76600|NCT01923805|O1|Outcome|Treatment Group|"Vitagel
Vitagel: Vitagel"
76601|NCT01923805|E2|Reported Event|Control|Standard of care for surgical hemostasis.
76602|NCT01923805|E1|Reported Event|Treatment Group|"Vitagel
Vitagel: Vitagel"
76603|NCT01923480|B4|Baseline|Total|Total of all reporting groups
76792|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76604|NCT01923480|B3|Baseline|15% CLINISOL 0.13 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection"
76605|NCT01923480|B2|Baseline|15% CLINISOL 0.08 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection"
76606|NCT01923480|B1|Baseline|15% CLINISOL 0.04 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection"
76607|NCT01923480|P6|Participant Flow|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76608|NCT01923480|P5|Participant Flow|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76609|NCT01923480|P4|Participant Flow|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
77059|NCT01921894|B1|Baseline|Cholecalciferol 4000 IU|Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks
76610|NCT01923480|P3|Participant Flow|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76611|NCT01923480|P2|Participant Flow|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76612|NCT01923480|P1|Participant Flow|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin
15% CLINISOL- Sulfite-Free (Amino Acid) Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76613|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76614|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76615|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76616|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76617|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76618|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76619|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76620|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76621|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76622|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76623|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76793|NCT01923389|E2|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76624|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76625|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76626|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76627|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76628|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76629|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76630|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76631|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76632|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76633|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76634|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76635|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76636|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76637|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76638|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76639|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76640|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76641|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76642|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76643|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76794|NCT01923389|E1|Reported Event|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76644|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76645|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76646|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76647|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76648|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76649|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76650|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76651|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76652|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76653|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76654|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76655|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76656|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76657|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76658|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76659|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76660|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76661|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76662|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76663|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76795|NCT01922986|B3|Baseline|Total|Total of all reporting groups
78377|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
76664|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76665|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76666|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76667|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76668|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76669|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76670|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76671|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76672|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76673|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76674|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76675|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76676|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76677|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76678|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76679|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76680|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76681|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76682|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76683|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76924|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76684|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76685|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76686|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76687|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76688|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76689|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76690|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76691|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76692|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76693|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76694|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76695|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76696|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76697|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76698|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76699|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76700|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76701|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76702|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76703|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76925|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76704|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76705|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76706|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76707|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76708|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76709|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76710|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76711|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76712|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76713|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76714|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76715|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76716|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76717|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76718|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76719|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76720|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76721|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76722|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76723|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76926|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
76724|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76725|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76726|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76727|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76728|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76729|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76730|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76731|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76732|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76733|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76734|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76735|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76736|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76737|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76738|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76739|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76740|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76741|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76742|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76743|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76927|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76744|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76745|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76746|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76747|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76748|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76749|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76750|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76751|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76752|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76753|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76754|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76755|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76756|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76757|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76758|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76759|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)"
76760|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76761|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76762|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
76763|NCT01923480|E3|Reported Event|15% CLINISOL 0.13 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection"
76850|NCT01922349|B3|Baseline|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
76764|NCT01923480|E2|Reported Event|15% CLINISOL 0.08 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection"
76765|NCT01923480|E1|Reported Event|15% CLINISOL 0.04 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection"
76766|NCT01923467|B1|Baseline|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.
Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.
Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
76800|NCT01922986|O2|Outcome|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy
sham rTMS: 20 minutes of sham rTMS stimulation
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
76801|NCT01922986|O1|Outcome|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy
active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
76767|NCT01923467|P1|Participant Flow|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.
Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.
Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
76768|NCT01923467|O1|Outcome|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.
Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.
Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
76769|NCT01923467|E1|Reported Event|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.
Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.
Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
76770|NCT01923389|B3|Baseline|Total|Total of all reporting groups
76771|NCT01923389|B2|Baseline|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76772|NCT01923389|B1|Baseline|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76773|NCT01923389|P2|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76774|NCT01923389|P1|Participant Flow|Placebo|Placebo (normal saline) was administered as a 20-milliliters (mL) intravenous (IV) infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76775|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76776|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76777|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76778|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76779|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76780|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76781|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76782|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76783|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76784|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76785|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76786|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76787|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76788|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76789|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
76790|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
78378|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
76796|NCT01922986|B2|Baseline|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy
sham rTMS: 20 minutes of sham rTMS stimulation
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
76797|NCT01922986|B1|Baseline|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy
active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
76798|NCT01922986|P2|Participant Flow|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy
sham rTMS: 20 minutes of sham rTMS stimulation
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
76799|NCT01922986|P1|Participant Flow|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy
active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
79429|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
76802|NCT01922986|O2|Outcome|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy
sham rTMS: 20 minutes of sham rTMS stimulation
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
76803|NCT01922986|O1|Outcome|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy
active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
76804|NCT01922986|O2|Outcome|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy
sham rTMS: 20 minutes of sham rTMS stimulation
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
76805|NCT01922986|O1|Outcome|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy
active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
76806|NCT01922986|E2|Reported Event|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy
sham rTMS: 20 minutes of sham rTMS stimulation
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
76807|NCT01922986|E1|Reported Event|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy
active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
76808|NCT01922934|B3|Baseline|Total|Total of all reporting groups
76809|NCT01922934|B2|Baseline|Registry-Based Control Group|Eligible subjects from an obesity registry (i.e. BMI >/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period.
76810|NCT01922934|B1|Baseline|Intervention Group|Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.
76811|NCT01922934|P2|Participant Flow|Control|"4302 Registry patients not selected to be offered the toolbox options will receive usual care for weight management. Usual care for obesity at DH includes brief weight loss advice provided by PCPs or prescribing of weight loss medication, for which patients pay out of pocket."
76812|NCT01922934|P1|Participant Flow|Intervention|"428 randomly-selected patients from four Denver Health clinics are identified for the intervention arm which offers a toolbox of weight loss options. The toolbox includes: self-monitoring tools; education materials; recreation center passes; commercial weight loss program vouchers (Weight Watchers); intensive group counseling (Colorado Weigh); meal replacements (shakes & entrees); and obesity pharmacotherapy (Qsymia & phentermine). At the initial assessment (visit 0), a computer program helps patients choose a personal treatment mode and they receive a starter kit with self-monitoring tools and meal replacements. Subjects must show self-monitoring of diet and exercise to receive more intensive therapies at their next visit (visit 1). At subsequent monthly visits, patients select a primary intensive therapy, but are able to add/change tools throughout the one year study period. Patients pay a $5-$10 co-pay for the therapies."
76813|NCT01922934|O2|Outcome|Registry-Based Control Group|Eligible subjects from an obesity registry (i.e. BMI >/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period.
76814|NCT01922934|O1|Outcome|Intervention Group|Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.
76815|NCT01922934|O1|Outcome|Random Sample of DHHA Registry Control Group|"We selected a random sample of 120 patients from the DHHA registry Control Group for a chart review. The dates used matched the study intervention period. Six reviewers, 3 MDs and 3 study personnel, reviewed medical records for the following:
Presence of ICD-9 code for obesity
Evidence that the the PCP discussed weight loss with the patient
Evidence of a specific intervention for weight management. Each record was evaluated by two reviewers, 1 MD and 1 study personnel ."
76816|NCT01922934|O2|Outcome|Registry-Based Control Group|Eligible subjects from an obesity registry (i.e. BMI >/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period.
76817|NCT01922934|O1|Outcome|Intervention Group|Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.
76818|NCT01922934|O2|Outcome|Registry-Based Control Group|Eligible subjects from an obesity registry (i.e. BMI >/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period. Included in analysis if they had both baseline and 12 month weights available.
76819|NCT01922934|O1|Outcome|Intervention Group|Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool. Included in analysis if they had both baseline and 12 month weights available.
76820|NCT01922934|E1|Reported Event|Intervention|"428 randomly-selected patients from four Denver Health clinics were selected to be offered a toolbox of weight loss options, including: self-monitoring tools; education materials; recreation center passes; commercial weight loss program vouchers (Weight Watchers); intensive group counseling (Colorado Weigh); meal replacements (shakes & entrees); and obesity pharmacotherapy (Qsymia & phentermine) for a $5-$10 co-pay for the therapies. Of these 428 patients, 140 came in and consented at the computer program visit at which these options were offered. 119 of these patients came in for a visit one where they received their tool for the first time. Adverse events from the group of 140 patients who consented to receive the intervention are reported."
76821|NCT01922739|B3|Baseline|Total|Total of all reporting groups
76822|NCT01922739|B2|Baseline|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
76860|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76823|NCT01922739|B1|Baseline|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
76824|NCT01922739|P1|Participant Flow|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
76825|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
76826|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
76827|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
76828|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
76829|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered extended-release hydrocodone tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open label treatment period of 22 weeks.
76830|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered extended-release hydrocodone tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
76831|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
76832|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
76851|NCT01922349|B2|Baseline|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
76833|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
76834|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
76835|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
76836|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
76837|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
76838|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
76839|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
76840|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
76841|NCT01922739|O5|Outcome|Hydrocodone ER: Open-Label Treatment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
76842|NCT01922739|O4|Outcome|Hydrocodone ER: Open-Label Adjustment Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks."
76843|NCT01922739|O3|Outcome|Placebo: Open-Label Adjustment Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks."
76844|NCT01922739|O2|Outcome|Hydrocodone ER: Double-Blind Titration Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks."
76845|NCT01922739|O1|Outcome|Placebo: Double-Blind Titration Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.
As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks."
76846|NCT01922739|E2|Reported Event|Hydrocodone ER - Open-Label Treatment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Treatment Period lasted 22 weeks.
76847|NCT01922739|E1|Reported Event|Hydrocodone ER - Titration/Adjustment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. The titration/adjustment period lasted 3-4 weeks.
76848|NCT01922349|B5|Baseline|Total|Total of all reporting groups
76849|NCT01922349|B4|Baseline|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
76852|NCT01922349|B1|Baseline|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
76853|NCT01922349|P4|Participant Flow|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
76854|NCT01922349|P3|Participant Flow|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
76855|NCT01922349|P2|Participant Flow|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
76856|NCT01922349|P1|Participant Flow|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (Multiple rising dose (MRD) period)
76857|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76858|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76859|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76979|NCT01922271|E2|Reported Event|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
76861|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76862|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76863|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76864|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76865|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76866|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76867|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76868|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76869|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76870|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76871|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76872|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76873|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76874|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76875|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76876|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76877|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76878|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76879|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76880|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76881|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76882|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76883|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76884|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76885|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76886|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76887|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76888|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76889|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76890|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76891|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76892|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76893|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76894|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76895|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76896|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 days in Chinese subjects (MRD period)
76897|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76898|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76899|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76900|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76901|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76902|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
76903|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
76904|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
76905|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
76906|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76907|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76908|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76909|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76910|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
76911|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76912|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76913|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
76914|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76915|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76916|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76917|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76918|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
76919|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76920|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76921|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
76922|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76923|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76928|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76929|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
76930|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76931|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76932|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76933|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76934|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
76935|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76936|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76937|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
76938|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76939|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76940|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76941|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76942|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
76943|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
76944|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
76945|NCT01922349|O4|Outcome|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
76946|NCT01922349|O3|Outcome|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
76947|NCT01922349|O2|Outcome|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
76948|NCT01922349|O1|Outcome|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
76949|NCT01922349|E11|Reported Event|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
76950|NCT01922349|E10|Reported Event|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
76951|NCT01922349|E9|Reported Event|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
76952|NCT01922349|E8|Reported Event|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
76953|NCT01922349|E7|Reported Event|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
76954|NCT01922349|E6|Reported Event|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
76955|NCT01922349|E5|Reported Event|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
76956|NCT01922349|E4|Reported Event|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 days (MRD period) in Chinese subjects
76957|NCT01922349|E3|Reported Event|Placebo- Caucasian|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
76958|NCT01922349|E2|Reported Event|Placebo- Japanese|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
76959|NCT01922349|E1|Reported Event|Placebo- Chinese|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
76960|NCT01922271|B3|Baseline|Total|Total of all reporting groups
76961|NCT01922271|B2|Baseline|Tiotropium Followed by NVA237|Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
76962|NCT01922271|B1|Baseline|NVA237 Followed by Tiotropium|Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
76998|NCT01922115|E2|Reported Event|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo"
76963|NCT01922271|P2|Participant Flow|Tiotropium Followed by NVA237|Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
76964|NCT01922271|P1|Participant Flow|NVA237 Followed by Tiotropium|Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
76965|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
76966|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
76967|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
76968|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
76969|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
76970|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
76971|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
76972|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
76973|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
76974|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
76975|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
76976|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
76977|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
76978|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
76981|NCT01922219|B1|Baseline|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).
Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
76982|NCT01922219|P1|Participant Flow|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).
Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
76983|NCT01922219|O1|Outcome|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).
Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
76984|NCT01922219|E1|Reported Event|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).
Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
76985|NCT01922115|B3|Baseline|Total|Total of all reporting groups
76986|NCT01922115|B2|Baseline|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo"
76987|NCT01922115|B1|Baseline|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
76988|NCT01922115|P2|Participant Flow|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo"
76989|NCT01922115|P1|Participant Flow|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
76990|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo"
76991|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
76992|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo"
76993|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
76994|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo"
76995|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
76996|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Placebo"
76997|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
76999|NCT01922115|E1|Reported Event|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
77000|NCT01922089|B3|Baseline|Total|Total of all reporting groups
77001|NCT01922089|B2|Baseline|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
77002|NCT01922089|B1|Baseline|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
77003|NCT01922089|P2|Participant Flow|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
77004|NCT01922089|P1|Participant Flow|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
77005|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
77006|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
77007|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
77008|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
77009|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
77010|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
77011|NCT01922089|E2|Reported Event|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
77012|NCT01922089|E1|Reported Event|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
77013|NCT01922011|B3|Baseline|Total|Total of all reporting groups
77733|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77014|NCT01922011|B2|Baseline|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h.
77015|NCT01922011|B1|Baseline|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
77016|NCT01922011|P2|Participant Flow|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg every six hours (q6h), or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h.
77017|NCT01922011|P1|Participant Flow|Daptomycin|Intravenous (IV) daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
77018|NCT01922011|O4|Outcome|Daptomycin 12 - < 18 Yrs Old|IV daptomycin 7 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 18 yrs old only.
77019|NCT01922011|O3|Outcome|Daptomycin 7 - < 12 Yrs Old|IV daptomycin 9 mg/kg once daily and ≤3 dummy infusions daily for ages 7 - < 12 yrs old only.
77020|NCT01922011|O2|Outcome|Daptomycin 24 Months - < 7 Yrs Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 24 months - < 7 yrs old only.
77021|NCT01922011|O1|Outcome|Daptomycin 12 - < 24 Months Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 24 months old only.
77022|NCT01922011|O4|Outcome|Daptomycin 12 - < 18 Yrs Old|IV daptomycin 7 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 18 yrs old only.
77023|NCT01922011|O3|Outcome|Daptomycin 7 - < 12 Yrs Old|IV daptomycin 9, mg/kg once daily and ≤3 dummy infusions daily for ages 7 - < 12 yrs old only.
77024|NCT01922011|O2|Outcome|Daptomycin 24 Months - < 7 Yrs Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 24 months - < 7 yrs old only.
77025|NCT01922011|O1|Outcome|Daptomycin 12 - < 24 Months Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 24 months old only.
77026|NCT01922011|O4|Outcome|Daptomycin 12 - < 18 Yrs Old|IV daptomycin 7 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 18 yrs old only.
77027|NCT01922011|O3|Outcome|Daptomycin 7 - < 12 Yrs Old|IV daptomycin 9 mg/kg once daily and ≤3 dummy infusions daily for ages 7 - < 12 yrs old only.
77028|NCT01922011|O2|Outcome|Daptomycin 24 Months - < 7 Yrs Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 24 months - < 7 yrs old only.
77029|NCT01922011|O1|Outcome|Daptomycin 12 - < 24 Months Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 24 months old only.
77030|NCT01922011|O4|Outcome|Daptomycin 12 - < 18 Yrs Old|IV daptomycin 7 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 18 yrs old only.
77031|NCT01922011|O3|Outcome|Daptomycin 7 - < 12 Yrs Old|IV daptomycin 9 mg/kg once daily and ≤3 dummy infusions daily for ages 7 - < 12 yrs old only.
77032|NCT01922011|O2|Outcome|Daptomycin 24 Months - < 7 Yrs Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 24 months - < 7 yrs old only.
77033|NCT01922011|O1|Outcome|Daptomycin 12 - < 24 Months Old|IV daptomycin 12 mg/kg once daily and ≤3 dummy infusions daily for ages 12 - < 24 months old only.
77034|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
77035|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
77036|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
77037|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
77038|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
77039|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
77040|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
77041|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
77042|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
77043|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
77044|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
77046|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
77047|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
77048|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
77049|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily.
77050|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
77051|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
77052|NCT01922011|O2|Outcome|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h
77053|NCT01922011|O1|Outcome|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
77054|NCT01922011|E2|Reported Event|Vancomycin or Nafcillin|IV vancomycin (or equivalent), 10 to 15 mg/kg q6h, or IV nafcillin (or β-lactam equivalent) 100-200 mg/kg/day, in divided doses q6h.
77055|NCT01922011|E1|Reported Event|Daptomycin|IV daptomycin 7, 9, or 12 mg/kg once daily and ≤3 dummy infusions daily
77056|NCT01921894|B4|Baseline|Total|Total of all reporting groups
77057|NCT01921894|B3|Baseline|Cholecalciferol 200 IU|Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks
77058|NCT01921894|B2|Baseline|Cholecalciferol 2000 IU|Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks
96177|NCT01806857|O2|Outcome|Matching Placebo|
77060|NCT01921894|P3|Participant Flow|Cholecalciferol 200 IU|"Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks
Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
77061|NCT01921894|P2|Participant Flow|Cholecalciferol 2000 IU|"Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks
Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
77062|NCT01921894|P1|Participant Flow|Cholecalciferol 4000 IU|"Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks
Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
77063|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
77064|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
77065|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
77066|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
77067|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
77068|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
77069|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
77070|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
77071|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
77072|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
77073|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
77074|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
77075|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
77076|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
77077|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
77078|NCT01921894|E3|Reported Event|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome includes any report of adverse events.
77079|NCT01921894|E2|Reported Event|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome includes any report of adverse events.
77080|NCT01921894|E1|Reported Event|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome includes any report of adverse events.
77081|NCT01921829|B3|Baseline|Total|Total of all reporting groups
77082|NCT01921829|B2|Baseline|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77392|NCT01920802|E2|Reported Event|Iloperidone|"6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks"
77083|NCT01921829|B1|Baseline|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77084|NCT01921829|P2|Participant Flow|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77085|NCT01921829|P1|Participant Flow|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77086|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77087|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77088|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77089|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77090|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77091|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77092|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77093|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77094|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77095|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77109|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77174|NCT01921101|O2|Outcome|Control|"participants will not receive intensive nutritional support from hospital admission to discharge
control: participants will receive standard care for nutrition received from hospital admission to discharge"
77096|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77097|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77098|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77099|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77100|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77101|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77102|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77103|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77104|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77105|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77106|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77107|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77108|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77172|NCT01921101|O2|Outcome|Control|"participants will not receive intensive nutritional support from hospital admission to discharge
control: participants will receive standard care for nutrition received from hospital admission to discharge"
77110|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77111|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77112|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77113|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
96178|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
77114|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77115|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77116|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77117|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77118|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77119|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77120|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77121|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77122|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77173|NCT01921101|O1|Outcome|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge
intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
77123|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77124|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77125|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77126|NCT01921829|O2|Outcome|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77127|NCT01921829|O1|Outcome|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77128|NCT01921829|E2|Reported Event|Protocolized Diuretic Strategy|Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is < 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is > 5 L/day, diuretic regimen will be reduced.
77129|NCT01921829|E1|Reported Event|Usual Care|Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
77130|NCT01921452|B1|Baseline|POC TSH Kits + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
77131|NCT01921452|P1|Participant Flow|POC TSH Kits + Third Generation Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
77132|NCT01921452|O1|Outcome|POC TSH Kits + Third Generation Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
77133|NCT01921452|O1|Outcome|POC TSH Kits + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
77134|NCT01921452|E1|Reported Event|POC TSH Kit + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
77135|NCT01921348|B3|Baseline|Total|Total of all reporting groups
77136|NCT01921348|B2|Baseline|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.
acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
77137|NCT01921348|B1|Baseline|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.
acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
77138|NCT01921348|P2|Participant Flow|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.
acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
77139|NCT01921348|P1|Participant Flow|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.
acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
77140|NCT01921348|O2|Outcome|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.
acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
77141|NCT01921348|O1|Outcome|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.
acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
77142|NCT01921348|O2|Outcome|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.
acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
77143|NCT01921348|O1|Outcome|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.
acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
77144|NCT01921348|O2|Outcome|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.
acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
77145|NCT01921348|O1|Outcome|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.
acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
77146|NCT01921348|E2|Reported Event|Sham|"33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.
acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis."
77147|NCT01921348|E1|Reported Event|Treatment|"34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.
acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis."
77148|NCT01921322|B3|Baseline|Total|Total of all reporting groups
77149|NCT01921322|B2|Baseline|Multiple Daily Injections|Multiple daily insulin injections used for treatment
77150|NCT01921322|B1|Baseline|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
77151|NCT01921322|P2|Participant Flow|Multiple Daily Injections|Multiple daily insulin injections used for treatment
77152|NCT01921322|P1|Participant Flow|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
77153|NCT01921322|O2|Outcome|Multiple Daily Injections|Multiple daily insulin injections used for treatment
77154|NCT01921322|O1|Outcome|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
77155|NCT01921322|O2|Outcome|Multiple Daily Injections|Multiple daily insulin injections used for treatment
77156|NCT01921322|O1|Outcome|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
77157|NCT01921322|E2|Reported Event|Multiple Daily Injections|Multiple daily insulin injections used for treatment
77158|NCT01921322|E1|Reported Event|Pump|Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
77159|NCT01921296|B1|Baseline|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
77160|NCT01921296|P1|Participant Flow|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
77161|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
77162|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
77163|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
77164|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
77165|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
77166|NCT01921296|E1|Reported Event|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
77167|NCT01921101|B3|Baseline|Total|Total of all reporting groups
77168|NCT01921101|B2|Baseline|Control|"participants will not receive intensive nutritional support from hospital admission to discharge
control: participants will receive standard care for nutrition received from hospital admission to discharge"
77169|NCT01921101|B1|Baseline|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge
intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
77170|NCT01921101|P2|Participant Flow|Control|"participants will not receive intensive nutritional support from hospital admission to discharge
control: participants will receive standard care for nutrition received from hospital admission to discharge"
77171|NCT01921101|P1|Participant Flow|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge
intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
77175|NCT01921101|O1|Outcome|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge
intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
77176|NCT01921101|E2|Reported Event|Control|"participants will not receive intensive nutritional support from hospital admission to discharge
control: participants will receive standard care for nutrition received from hospital admission to discharge"
77177|NCT01921101|E1|Reported Event|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge
intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
77178|NCT01920958|B1|Baseline|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77179|NCT01920958|P1|Participant Flow|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77180|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77181|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77182|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77779|NCT01917773|O1|Outcome|15 Minutes|The MI for the 15 minutes before and after octreotide infusion was measured.
77183|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77184|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77185|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77186|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77187|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77188|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77189|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77190|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77191|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77192|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77193|NCT01920958|E1|Reported Event|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
77194|NCT01920893|B3|Baseline|Total|Total of all reporting groups
77195|NCT01920893|B2|Baseline|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77196|NCT01920893|B1|Baseline|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77197|NCT01920893|P2|Participant Flow|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77198|NCT01920893|P1|Participant Flow|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to MFNS.
77199|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77200|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77201|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77202|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77203|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection every week from Week 1 to 15 added to MFNS.
77204|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77205|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77206|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77207|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77208|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77209|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77210|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77211|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77212|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77213|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77214|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77215|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77216|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77734|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77217|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77218|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77219|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
77220|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
77221|NCT01920893|E2|Reported Event|Dupilumab 300 mg QW|Participants exposed to dupilumab added to MFNS (mean exposure of 16 weeks).
77222|NCT01920893|E1|Reported Event|Placebo|Participants exposed to placebo (for dupilumab) added to MFNS (mean exposure of 14 weeks).
77223|NCT01920854|B8|Baseline|Total|Total of all reporting groups
77224|NCT01920854|B7|Baseline|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77225|NCT01920854|B6|Baseline|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77226|NCT01920854|B5|Baseline|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77227|NCT01920854|B4|Baseline|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77228|NCT01920854|B3|Baseline|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77229|NCT01920854|B2|Baseline|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77230|NCT01920854|B1|Baseline|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
77231|NCT01920854|P7|Participant Flow|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77232|NCT01920854|P6|Participant Flow|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77233|NCT01920854|P5|Participant Flow|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77252|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77234|NCT01920854|P4|Participant Flow|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77235|NCT01920854|P3|Participant Flow|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77236|NCT01920854|P2|Participant Flow|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77237|NCT01920854|P1|Participant Flow|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
77735|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
99461|NCT01785615|O1|Outcome|Healthy Women|
77238|NCT01920854|O7|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77239|NCT01920854|O6|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77240|NCT01920854|O5|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77241|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77242|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77243|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77244|NCT01920854|O1|Outcome|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
77245|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77246|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77247|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77248|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77249|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77250|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77251|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77382|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks
Placebo: BID up to 4 weeks"
77383|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks"
77384|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks"
77253|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77254|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77255|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77256|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
79430|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
77257|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77258|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77259|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77260|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77261|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77262|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77263|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77264|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77265|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77266|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77267|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77268|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77269|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77270|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77271|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77385|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks
Placebo: BID up to 4 weeks"
77272|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77273|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77274|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77275|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
77276|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
77277|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77278|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77279|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77280|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77281|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77282|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77283|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
77284|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
77285|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77286|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77287|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77288|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77289|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77290|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77291|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77292|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77293|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77294|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
79431|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
77295|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77296|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77297|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77298|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77299|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77300|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77301|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77302|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77303|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
77304|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
77305|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77306|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77307|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
77308|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77309|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
78379|NCT01913470|E2|Reported Event|Placebo|Recipients of treatment with a placebo for 8 weeks.
77310|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77311|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77312|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
77313|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77314|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77315|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
77316|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77317|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77318|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77319|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77320|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
77321|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77322|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77323|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
77324|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77325|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77326|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77327|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77328|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
77329|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77330|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77331|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
77332|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
105556|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
77333|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77334|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77335|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77336|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
77337|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77338|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77339|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
77340|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77341|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77342|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77343|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77344|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
77345|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77346|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77347|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
77348|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77349|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77350|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77351|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77352|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
77353|NCT01920854|E7|Reported Event|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
77354|NCT01920854|E6|Reported Event|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
77355|NCT01920854|E5|Reported Event|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
77356|NCT01920854|E4|Reported Event|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
77357|NCT01920854|E3|Reported Event|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
77358|NCT01920854|E2|Reported Event|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
77359|NCT01920854|E1|Reported Event|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
77360|NCT01920802|B4|Baseline|Total|Total of all reporting groups
77361|NCT01920802|B3|Baseline|Placebo|"BID placebo up to 4 weeks
Placebo: BID up to 4 weeks"
77362|NCT01920802|B2|Baseline|Iloperidone|"6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks"
77363|NCT01920802|B1|Baseline|Olanzapine|"5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks"
77364|NCT01920802|P3|Participant Flow|Placebo|"BID placebo up to 4 weeks
Placebo: BID up to 4 weeks"
77365|NCT01920802|P2|Participant Flow|Iloperidone|"6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks"
77366|NCT01920802|P1|Participant Flow|Olanzapine|"5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks"
77367|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks
Placebo: BID up to 4 weeks"
77368|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks"
77369|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks"
77370|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks
Placebo: BID up to 4 weeks"
77371|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks"
77372|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks"
77373|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks
Placebo: BID up to 4 weeks"
77374|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks"
77375|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks"
77376|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks
Placebo: BID up to 4 weeks"
77377|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks"
77378|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks"
77379|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks
Placebo: BID up to 4 weeks"
77380|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks
iloperidone: 6 mg BID up to 4 weeks"
77381|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks"
77393|NCT01920802|E1|Reported Event|Olanzapine|"5mg BID olanzapine for up to 4 weeks
olanzapine: 5mg BID up to 4 weeks"
77394|NCT01920568|B3|Baseline|Total|Total of all reporting groups
77395|NCT01920568|B2|Baseline|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77396|NCT01920568|B1|Baseline|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77397|NCT01920568|P2|Participant Flow|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77445|NCT01920178|E2|Reported Event|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77398|NCT01920568|P1|Participant Flow|Denosumab 120 mg|Participants received denosumab 120 milligrams (mg) as subcutaneous (SC) injection for a maximum of 13 doses and placebo as intravenous (IV) infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 international unit (IU) of vitamin D.
77399|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77400|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77401|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77402|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77403|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77404|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77405|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77406|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77407|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77408|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77409|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77410|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77411|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77412|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77413|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77414|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77415|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77548|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
77416|NCT01920568|E2|Reported Event|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77417|NCT01920568|E1|Reported Event|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
77418|NCT01920282|B4|Baseline|Total|Total of all reporting groups
77446|NCT01920178|E1|Reported Event|PinPointe Foot Laser|"Active laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77447|NCT01919996|B1|Baseline|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
77419|NCT01920282|B3|Baseline|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Nebivolol plus Lifestyle Modification"
77420|NCT01920282|B2|Baseline|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Lifestyle Modification"
77421|NCT01920282|B1|Baseline|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.
Nebivolol"
77422|NCT01920282|P3|Participant Flow|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Nebivolol plus Lifestyle Modification"
77423|NCT01920282|P2|Participant Flow|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Lifestyle Modification"
77424|NCT01920282|P1|Participant Flow|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.
Nebivolol"
77425|NCT01920282|O3|Outcome|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Nebivolol plus Lifestyle Modification"
77426|NCT01920282|O2|Outcome|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Lifestyle Modification"
77427|NCT01920282|O1|Outcome|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.
Nebivolol"
77444|NCT01920178|O1|Outcome|PinPointe Foot Laser|"Active laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77448|NCT01919996|P1|Participant Flow|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
77449|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
77450|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
79432|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
77428|NCT01920282|O3|Outcome|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Nebivolol plus Lifestyle Modification"
77429|NCT01920282|O2|Outcome|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Lifestyle Modification"
77430|NCT01920282|O1|Outcome|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.
Nebivolol"
77431|NCT01920282|E3|Reported Event|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Nebivolol plus Lifestyle Modification"
77432|NCT01920282|E2|Reported Event|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Lifestyle Modification"
77433|NCT01920282|E1|Reported Event|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.
Nebivolol"
77434|NCT01920178|B3|Baseline|Total|Total of all reporting groups
77435|NCT01920178|B2|Baseline|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77436|NCT01920178|B1|Baseline|PinPointe Foot Laser|"Active laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77437|NCT01920178|P2|Participant Flow|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77438|NCT01920178|P1|Participant Flow|PinPointe Foot Laser|"Active laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77439|NCT01920178|O2|Outcome|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77440|NCT01920178|O1|Outcome|PinPointe Foot Laser|"Active laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77441|NCT01920178|O2|Outcome|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77442|NCT01920178|O1|Outcome|PinPointe Foot Laser|"Active laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77443|NCT01920178|O2|Outcome|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
77480|NCT01919723|B2|Baseline|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)
Ticagrelor: Ticagrelor loading dose
Eptifibatide: i.v. infusion"
77451|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
77452|NCT01919996|E1|Reported Event|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
77453|NCT01919801|B3|Baseline|Total|Total of all reporting groups
77454|NCT01919801|B2|Baseline|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77455|NCT01919801|B1|Baseline|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77456|NCT01919801|P2|Participant Flow|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77457|NCT01919801|P1|Participant Flow|Icatibant 30 mg|Participants received a single dose of icatibant 30 milligram (mg) subcutaneous (SC) injection within 12 hours after the onset of the angiotensin-converting enzyme inhibitor (ACE-I) induced angioedema attack.
77458|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77459|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77460|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77461|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77462|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77463|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77464|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77465|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77466|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77467|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77468|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77469|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77470|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77471|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77472|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77473|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77474|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77475|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77476|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77477|NCT01919801|E2|Reported Event|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77478|NCT01919801|E1|Reported Event|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
77479|NCT01919723|B3|Baseline|Total|Total of all reporting groups
77547|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
77481|NCT01919723|B1|Baseline|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
Ticagrelor: Ticagrelor loading dose
Eptifibatide: i.v. infusion"
77482|NCT01919723|P2|Participant Flow|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
77483|NCT01919723|P1|Participant Flow|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
77484|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
77485|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
77486|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
79433|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
77487|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
77488|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
77489|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
77490|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
77491|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
77492|NCT01919723|E2|Reported Event|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
77493|NCT01919723|E1|Reported Event|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
ticagrelor: ticagrelor loading dose
Eptifibatide: i.v. infusion"
77494|NCT01919606|B3|Baseline|Total|Total of all reporting groups
77495|NCT01919606|B2|Baseline|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
77496|NCT01919606|B1|Baseline|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
77497|NCT01919606|P2|Participant Flow|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
77498|NCT01919606|P1|Participant Flow|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
77499|NCT01919606|O2|Outcome|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
77500|NCT01919606|O1|Outcome|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
77501|NCT01919606|O2|Outcome|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
77502|NCT01919606|O1|Outcome|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
77503|NCT01919606|E2|Reported Event|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
77504|NCT01919606|E1|Reported Event|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL
EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
77505|NCT01919450|B5|Baseline|Total|Total of all reporting groups
77506|NCT01919450|B4|Baseline|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77507|NCT01919450|B3|Baseline|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77508|NCT01919450|B2|Baseline|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77509|NCT01919450|B1|Baseline|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77510|NCT01919450|P4|Participant Flow|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77511|NCT01919450|P3|Participant Flow|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77512|NCT01919450|P2|Participant Flow|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77513|NCT01919450|P1|Participant Flow|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77514|NCT01919450|O1|Outcome|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77515|NCT01919450|O1|Outcome|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77516|NCT01919450|O1|Outcome|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77517|NCT01919450|O1|Outcome|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77518|NCT01919450|E4|Reported Event|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77519|NCT01919450|E3|Reported Event|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77520|NCT01919450|E2|Reported Event|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77521|NCT01919450|E1|Reported Event|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
77522|NCT01919229|B4|Baseline|Total|Total of all reporting groups
77523|NCT01919229|B3|Baseline|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
77524|NCT01919229|B2|Baseline|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
77525|NCT01919229|B1|Baseline|Letrozole|Letrozole 2.5 mg alone once daily
77526|NCT01919229|P3|Participant Flow|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
77527|NCT01919229|P2|Participant Flow|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
77528|NCT01919229|P1|Participant Flow|Letrozole|Letrozole 2.5 mg alone once daily
77529|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
77530|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
77531|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
77532|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
77533|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
77534|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
77535|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
77536|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
77537|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
77538|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
77539|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
77540|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
77541|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
77542|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
77543|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
77544|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
77545|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
77546|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
77550|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
77551|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
77552|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
77553|NCT01919229|E3|Reported Event|LEE600mgqd+Letrozole2.5mgqd|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
77554|NCT01919229|E2|Reported Event|LEE400mgqd+Letrozole2.5mgqd|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
77555|NCT01919229|E1|Reported Event|Letrozole2.5mgqd|Letrozole 2.5 mg alone once daily
77556|NCT01918800|B3|Baseline|Total|Total of all reporting groups
77557|NCT01918800|B2|Baseline|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.
MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
77558|NCT01918800|B1|Baseline|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
77559|NCT01918800|P2|Participant Flow|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.
MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
77560|NCT01918800|P1|Participant Flow|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
77561|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.
MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
77562|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
77563|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.
MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
77564|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
77565|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.
MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
77566|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
77567|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.
MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
77568|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
77569|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.
MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
77570|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
77571|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.
MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
77572|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
77573|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.
MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
77574|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
77575|NCT01918800|E2|Reported Event|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.
MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
77576|NCT01918800|E1|Reported Event|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
77577|NCT01918371|B3|Baseline|Total|Total of all reporting groups
77578|NCT01918371|B2|Baseline|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77579|NCT01918371|B1|Baseline|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77580|NCT01918371|P2|Participant Flow|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77581|NCT01918371|P1|Participant Flow|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77582|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77583|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77584|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77585|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77586|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77729|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77587|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77588|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77589|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77590|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77591|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77592|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77593|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77594|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77595|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77596|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77597|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77598|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77599|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77600|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77601|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77602|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77603|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77604|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77605|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77606|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77607|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77608|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77719|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77609|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77610|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77611|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77612|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77613|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77614|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77615|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77616|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77617|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77618|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77619|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77620|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77621|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77622|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77623|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77624|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77625|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77626|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77627|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77628|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77629|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77630|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77631|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77632|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77633|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77634|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77635|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77720|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
78380|NCT01913470|E1|Reported Event|Losartan|Recipients of treatment with losartan for 8 weeks.
77636|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77637|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77638|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77639|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77640|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77641|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77642|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77643|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77644|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77645|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77646|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77647|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77648|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77649|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77650|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77651|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77652|NCT01918371|E2|Reported Event|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77653|NCT01918371|E1|Reported Event|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
77654|NCT01918332|B5|Baseline|Total|Total of all reporting groups
77655|NCT01918332|B4|Baseline|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg placebo
Rosuvastatin 20mg placebo"
77656|NCT01918332|B3|Baseline|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Rosuvastatin 20mg
Valsartan 160mg placebo"
77657|NCT01918332|B2|Baseline|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg placebo"
77658|NCT01918332|B1|Baseline|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg"
77659|NCT01918332|P4|Participant Flow|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg placebo
Rosuvastatin 20mg placebo"
77660|NCT01918332|P3|Participant Flow|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Rosuvastatin 20mg
Valsartan 160mg placebo"
77661|NCT01918332|P2|Participant Flow|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg placebo"
77662|NCT01918332|P1|Participant Flow|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg"
77663|NCT01918332|O2|Outcome|V160 & Placebo|Valsartan 160mg + Rosuvastatin 20mg placebo & Placebo
77664|NCT01918332|O1|Outcome|V160+R20 & R20|Valsartan 160mg + Rosuvastatin 20mg & Valsartan 160mg placebo + Rosuvastatin 20mg
77665|NCT01918332|O2|Outcome|R20 & Placebo|Valsartan 160mg placebo + Rosuvastatin 20mg & Placebo
77666|NCT01918332|O1|Outcome|V160+R20 & V160|Valsartan 160mg + Rosuvastatin 20mg & Valsartan 160mg + Rosuvastatin 20mg placebo
78480|NCT01912404|O2|Outcome|Placebo|Matching Placebo capsules twice daily for 28 days
77667|NCT01918332|E4|Reported Event|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg placebo
Rosuvastatin 20mg placebo"
77668|NCT01918332|E3|Reported Event|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Rosuvastatin 20mg
Valsartan 160mg placebo"
77669|NCT01918332|E2|Reported Event|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg placebo"
77670|NCT01918332|E1|Reported Event|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg"
77671|NCT01918306|B3|Baseline|Total|Total of all reporting groups
77730|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77736|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77672|NCT01918306|B2|Baseline|Cisplatin and GDC-0941|"Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.
In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
GDC -0941: Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 PO QD on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity"
77673|NCT01918306|B1|Baseline|Cisplatin|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.
cisplatin: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.
In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77674|NCT01918306|P4|Participant Flow|2PHII2 - Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77675|NCT01918306|P3|Participant Flow|2PHII1 - Arm 1 - Cisplatin Only|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.
cisplatin: In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77676|NCT01918306|P2|Participant Flow|1PHIbB - Arm B - Cisplatin + GDC -0941 Dose Level -1|If 2 or more patients in 3 or 6 patients (cohort 1 and 2) treated at a given dose 260 mg experience DLT, the dose will be de-escalated to the next lower dose level.
77677|NCT01918306|P1|Participant Flow|1PHIbA - Arm A - Cisplatin + GDC -0941 Dose Level 1 Cohort 1&2|"Patients receive cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PI3K inhibitor: GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
77678|NCT01918306|O3|Outcome|2PHIICO - Crossover to Arm 2 - Cistplatin + GDC - 0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77679|NCT01918306|O2|Outcome|2PHII2 - Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77680|NCT01918306|O1|Outcome|2PHII1 - Arm 1 - Cisplatin|"Patients receive Cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.
Cisplatin: patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77721|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77722|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77681|NCT01918306|O3|Outcome|2PHIICO - Crossover to 2 - Cisplatin + GDC-0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77731|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77732|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77682|NCT01918306|O2|Outcome|2PHII2 - ARM 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77683|NCT01918306|O1|Outcome|2 PHII1 - ARM 1 Cisplatin|"Patients receive Cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.
Cisplatin: patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77684|NCT01918306|O3|Outcome|1PHIbB - Arm B - Cistplatin + GDC -0941 Dose Level -1|If 2 or more patients in 3 or 6 patients (cohort 1 and 2) treated at a given dose 260 mg experience DLT, the dose will be de-escalated to the next lower dose level.
77685|NCT01918306|O2|Outcome|1 PHIbA - Arm 1 - Cisplatin and GDC-0941Cohort 2|"Starting dose of GDC - 0941 260mg, no DLT's experienced in cohort 1. Therefore no de-escalation of the intensity of the dose was necessary. An additional cohort of 3 patients will be treated at the same dose level beginning at the highest dose level. (Highest dose = 260mg)
In cohort 2, patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also received PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
≤1 patient has a DLT in 6 treated at this same dose, this will be considered a tolerable dose to move to phase II."
77686|NCT01918306|O1|Outcome|1PHIbA - Cisplatin and GDC-0941 Cohort 1|"Starting dose of GDC - 0941 260mg. De-escalation of the intensity of the dose (if necessary) will proceed among cohorts of 3 patients according to a standard 3+3 algorithm beginning at the highest dose level. (Highest dose = 260mg)
In cohort 1 patients received Cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also received PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
77687|NCT01918306|O3|Outcome|2PHIICO - Crossover to Arm 2 - Cisplatin and GDC-0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77688|NCT01918306|O2|Outcome|2PHII2 Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77689|NCT01918306|O1|Outcome|2PHII1 Arm 1 Cisplatin|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.
cisplatin:patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77690|NCT01918306|O1|Outcome|1PHIbA -Cisplatin and GDC-0941|"Patients receive cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PI3K inhibitor: GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
77691|NCT01918306|E5|Reported Event|2PHIICO - Crossover to Arm 2 - Cistplatin + GDC -0941|"Crossover patient received Cisplatin and PI3K inhibitor GDC-0941 after found to have disease progression in Cisplatin only arm. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
patient received PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77692|NCT01918306|E4|Reported Event|2PHII2 - Arm 2 - Cisplatin and GDC-0941|"Patients receive Cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
patients receive PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies
GDC -0941: Patients receive cisplatin as in Arm I and PI3K"
77693|NCT01918306|E3|Reported Event|2PHII 1 - Arm 1 - Cisplatin Only|"Patients receive cisplatin in Arm I. Patients may crossover to Arm II upon disease progression.
cisplatin:patients received cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI: correlative studies"
77694|NCT01918306|E2|Reported Event|1PHIbB - Arm B - Cisplatin + GDC -0941 Dose Level -1|If 2 or more patients in 3 or 6 patients (cohort 1 and 2) treated at a given dose 260 mg experience DLT, the dose will be de-escalated to the next lower dose level.
77695|NCT01918306|E1|Reported Event|1PHIbA - Arm A - Cisplatin + GDC - 0941 Dose Level 1|"Patients cohort 1 receive cisplatin and PI3K inhibitor GDC-0941. Courses repeat in the absence of disease progression or unacceptable toxicity.
cisplatin: patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PI3K inhibitor: GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
If no patients in Cohort 1 experienced DLT's after 4 weeks, all patients in Cohort 2 will receive cisplatin and PI3K inhibitor GDC-0941, GDC-0941dose not to exceed 260mg.
If 1 patient experiences a DLT in the first cohort, an additional cohort of 3 patients will be treated at the same dose level in cohort 2.
If ≤1 patient has a DLT in 6 (cohort 1 and 2) treated at this same dose, this will be considered a tolerable dose to move to phase II."
77696|NCT01918085|B3|Baseline|Total|Total of all reporting groups
77697|NCT01918085|B2|Baseline|Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin
Strata strip : An adhesive strip made of the Strata adhesive
Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
77698|NCT01918085|B1|Baseline|Pre-stripped Abdominal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin
Strata strip : An adhesive strip made of the Strata adhesive
Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
77699|NCT01918085|P2|Participant Flow|First Peristomal Skin, Then Pre-stripped Abdomianl Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin
Strata strip : An adhesive strip made of the Strata adhesive
Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
77700|NCT01918085|P1|Participant Flow|First Pre-stripped Abdominal Skin, Then Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin
Strata strip : An adhesive strip made of the Strata adhesive
Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
77701|NCT01918085|O4|Outcome|Peristomal Skin - Hydrocolloid Adhesive|"The peel force used to remove a hydrocolloid strip from the Peristomal skin
hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive"
77702|NCT01918085|O3|Outcome|Pre-stripped Abdominal Skin - Hydrocolloid Adhesive|"The peel force used to remove a hydrocolloid strip from the Peristomal skin
hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive"
77703|NCT01918085|O2|Outcome|Pre-stripped Abdominal Skin -Strata Adhesive|"The peel force used to remove a strata strip from healthy abdominal skin
Strata strip : An adhesive strip made of the Strata adhesive"
77704|NCT01918085|O1|Outcome|Peristomal Skin- Strata Adhesive|"The peel force used to remove a strata strip) from the Peristomal skin
Strata strip : An adhesive strip made of the Strata adhesive"
77705|NCT01918085|E2|Reported Event|Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin
Strata strip : An adhesive strip made of the Strata adhesive
Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
77706|NCT01918085|E1|Reported Event|Pre-stripped Abdominal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin
Strata strip : An adhesive strip made of the Strata adhesive
Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
77707|NCT01918033|B4|Baseline|Total|Total of all reporting groups
77708|NCT01918033|B3|Baseline|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77709|NCT01918033|B2|Baseline|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77710|NCT01918033|B1|Baseline|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77711|NCT01918033|P3|Participant Flow|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77712|NCT01918033|P2|Participant Flow|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77713|NCT01918033|P1|Participant Flow|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77714|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77715|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77716|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77717|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77718|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77723|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77724|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77725|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77726|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77727|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77728|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77737|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77738|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77739|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77740|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77741|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77742|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77743|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77744|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77745|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77746|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77747|NCT01918033|E3|Reported Event|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
77748|NCT01918033|E2|Reported Event|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
77749|NCT01918033|E1|Reported Event|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
77750|NCT01917812|B4|Baseline|Total|Total of all reporting groups
77751|NCT01917812|B3|Baseline|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.
Smart Text Messaging = Group receives personalized, health coaching via smart text messages.
Unblinded Digital Activity Tracker
Smart Text Messaging"
77752|NCT01917812|B2|Baseline|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.
Unblinded Digital Activity Tracker"
77753|NCT01917812|B1|Baseline|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.
Blinded Digital Activity Tracker"
77754|NCT01917812|P3|Participant Flow|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.
Smart Text Messaging = Group receives personalized, health coaching via smart text messages.
Unblinded Digital Activity Tracker
Smart Text Messaging"
77755|NCT01917812|P2|Participant Flow|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.
No Smart Text Messaging = Group does not receive personalized, health coaching via smart text messages.
Unblinded Digital Activity Tracker"
77756|NCT01917812|P1|Participant Flow|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.
Blinded Digital Activity Tracker"
77757|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
77758|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
77759|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
77760|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
77761|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
77762|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
77763|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
77764|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
77765|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
77766|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
77767|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
77768|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
77769|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
77770|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
77771|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
78481|NCT01912404|O1|Outcome|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
77772|NCT01917812|E3|Reported Event|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.
Smart Text Messaging = Group receives personalized, health coaching via smart text messages.
Unblinded Digital Activity Tracker
Smart Text Messaging"
77773|NCT01917812|E2|Reported Event|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.
Unblinded Digital Activity Tracker"
77774|NCT01917812|E1|Reported Event|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.
Blinded Digital Activity Tracker"
77775|NCT01917773|B1|Baseline|Octreotide|"Fasting motility was recorded for at least 60 minutes.
Octreotide 1mcg/kg, maximum of 50mcg was administered subcutaneously (one hour after application of EMLA topical cream). Motility was then recorded for 45-60 minutes.
Patients were then offered a high-fat, high-energy meal as described elsewhere, and motility was recorded for 60 minutes.
Patients then received 1 to 2 doses of bisacodyl (0.2 mg/kg, maximum of 10 mg) through the motility catheter, and motility was recorded."
77776|NCT01917773|P1|Participant Flow|Octreotide|This was a non-randomized, single center, open label, and prospective study. Thirteen patients were enrolled in the study. All patient received Octreotide as per study protocol.
77777|NCT01917773|O3|Outcome|45 Minutes|The MI for the 45 minutes before and after octreotide infusion was measured.
77778|NCT01917773|O2|Outcome|30 Minutes|The MI for the 30 minutes before and after octreotide infusion was measured.
77780|NCT01917773|E1|Reported Event|All Patients|All 13 patient received octreotide injection. Motility Index (MI) (mm Hg) for the 15 minutes before and after octreotide infusion was measured.
77781|NCT01917656|B3|Baseline|Total|Total of all reporting groups
77782|NCT01917656|B2|Baseline|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77783|NCT01917656|B1|Baseline|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77784|NCT01917656|P2|Participant Flow|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77785|NCT01917656|P1|Participant Flow|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77786|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77787|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77788|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77789|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77790|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77791|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77792|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77793|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77794|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77795|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77796|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77797|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77798|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77799|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77800|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77801|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77802|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77803|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77804|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77805|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77806|NCT01917656|E2|Reported Event|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
77807|NCT01917656|E1|Reported Event|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
77808|NCT01917526|B3|Baseline|Total|Total of all reporting groups
77809|NCT01917526|B2|Baseline|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen cannula"
77810|NCT01917526|B1|Baseline|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen mask"
77811|NCT01917526|P2|Participant Flow|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen cannula"
77812|NCT01917526|P1|Participant Flow|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen mask"
77813|NCT01917526|O2|Outcome|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen cannula"
77814|NCT01917526|O1|Outcome|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen mask"
77815|NCT01917526|O2|Outcome|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen cannula"
77816|NCT01917526|O1|Outcome|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen mask"
77817|NCT01917526|E2|Reported Event|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen cannula"
77818|NCT01917526|E1|Reported Event|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen mask"
77819|NCT01917344|B1|Baseline|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination
MRI"
77820|NCT01917344|P1|Participant Flow|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination
MRI"
77821|NCT01917344|O1|Outcome|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination
MRI"
77822|NCT01917344|E1|Reported Event|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination
MRI"
77823|NCT01917214|B1|Baseline|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
77824|NCT01917214|P1|Participant Flow|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
77825|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
77826|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
77827|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
77828|NCT01917214|O1|Outcome|mRCC Cohort: Sutent Therapy and BSC|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
77829|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
77830|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
77831|NCT01917214|E1|Reported Event|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
77832|NCT01916980|B3|Baseline|Total|Total of all reporting groups
77833|NCT01916980|B2|Baseline|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77889|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77890|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77834|NCT01916980|B1|Baseline|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77835|NCT01916980|P2|Participant Flow|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77836|NCT01916980|P1|Participant Flow|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77837|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77857|NCT01916967|P1|Participant Flow|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
79434|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
77838|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77839|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77840|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77841|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77842|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77843|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77844|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77845|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77846|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77847|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77848|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77891|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77892|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77849|NCT01916980|E2|Reported Event|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77850|NCT01916980|E1|Reported Event|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
77851|NCT01916967|B4|Baseline|Total|Total of all reporting groups
77852|NCT01916967|B3|Baseline|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77853|NCT01916967|B2|Baseline|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77854|NCT01916967|B1|Baseline|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77855|NCT01916967|P3|Participant Flow|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77856|NCT01916967|P2|Participant Flow|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77858|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77859|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77860|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77861|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77862|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77863|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77864|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77865|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77866|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77867|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77868|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77869|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77870|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77871|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77872|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77873|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77874|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77875|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77876|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77877|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77878|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77879|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77880|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77881|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77882|NCT01916967|O4|Outcome|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
77883|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77884|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77885|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77886|NCT01916967|O4|Outcome|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
77887|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77888|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77893|NCT01916967|E4|Reported Event|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
77894|NCT01916967|E3|Reported Event|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
77895|NCT01916967|E2|Reported Event|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
77896|NCT01916967|E1|Reported Event|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
77897|NCT01916928|B1|Baseline|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
77898|NCT01916928|P1|Participant Flow|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
77899|NCT01916928|O1|Outcome|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
77900|NCT01916928|E1|Reported Event|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
77901|NCT01916681|B5|Baseline|Total|Total of all reporting groups
77902|NCT01916681|B4|Baseline|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
Cervical Foley & Pitocin: A cervical foley combined with pitocin will be used to induce the patient"
77903|NCT01916681|B3|Baseline|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.
Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
77904|NCT01916681|B2|Baseline|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.
Misoprostol Alone: Misoprostol will be used alone to induce the patient"
77905|NCT01916681|B1|Baseline|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
77906|NCT01916681|P4|Participant Flow|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
77907|NCT01916681|P3|Participant Flow|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.
Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
77908|NCT01916681|P2|Participant Flow|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.
Misoprostol Alone: Misoprostol will be used alone to induce the patient"
77909|NCT01916681|P1|Participant Flow|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
77910|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
77911|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.
Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
77912|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.
Misoprostol Alone: Misoprostol will be used alone to induce the patient"
77913|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
77914|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
77915|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.
Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
77916|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.
Misoprostol Alone: Misoprostol will be used alone to induce the patient"
77917|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
77918|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
77919|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.
Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
77920|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.
Misoprostol Alone: Misoprostol will be used alone to induce the patient"
77921|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
77922|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
77923|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.
Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
77924|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.
Misoprostol Alone: Misoprostol will be used alone to induce the patient"
77925|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
77926|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
77927|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.
Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
77928|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.
Misoprostol Alone: Misoprostol will be used alone to induce the patient"
77929|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
77930|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
77931|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.
Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
77932|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.
Misoprostol Alone: Misoprostol will be used alone to induce the patient"
78177|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
77933|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
77934|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
77935|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.
Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
77936|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.
Misoprostol Alone: Misoprostol will be used alone to induce the patient"
77937|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
77938|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
Cervical Foley & Pitocin: A cervical foley combined with pitocin will be used to induce the patient"
77939|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.
Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
77940|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.
Misoprostol Alone: Misoprostol will be used alone to induce the patient"
77941|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
77942|NCT01916681|E4|Reported Event|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.
Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
77943|NCT01916681|E3|Reported Event|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.
Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
77944|NCT01916681|E2|Reported Event|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.
Misoprostol Alone: Misoprostol will be used alone to induce the patient"
77945|NCT01916681|E1|Reported Event|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.
Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
77946|NCT01916629|B3|Baseline|Total|Total of all reporting groups
77947|NCT01916629|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
77948|NCT01916629|B1|Baseline|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis
Photocil for Psoriasis: Photocil for Psoriasis"
77949|NCT01916629|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
77950|NCT01916629|P1|Participant Flow|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis
Photocil for Psoriasis: Photocil for Psoriasis"
77951|NCT01916629|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
77952|NCT01916629|O1|Outcome|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis
Photocil for Psoriasis: Photocil for Psoriasis"
77953|NCT01916629|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
77954|NCT01916629|E1|Reported Event|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis
Photocil for Psoriasis: Photocil for Psoriasis"
77955|NCT01916590|B3|Baseline|Total|Total of all reporting groups
77956|NCT01916590|B2|Baseline|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.
placebo"
77980|NCT01916226|P1|Participant Flow|FPNS 200 μg|Participants self-administered fluticasone propionate nasal spray (FPNS) 200 micrograms (µg) per day as two sprays in each nostril (50 μg per spray) once daily in the morning (AM) for 2 weeks.
77981|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
77957|NCT01916590|B1|Baseline|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.
Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
77958|NCT01916590|P2|Participant Flow|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.
placebo"
77959|NCT01916590|P1|Participant Flow|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.
Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
78178|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
77960|NCT01916590|O2|Outcome|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.
placebo"
77961|NCT01916590|O1|Outcome|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.
Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
77962|NCT01916590|E2|Reported Event|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.
placebo"
77963|NCT01916590|E1|Reported Event|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.
Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
77964|NCT01916304|B1|Baseline|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
77965|NCT01916304|P1|Participant Flow|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
77966|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
77967|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
77968|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
77969|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
77970|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
77971|NCT01916304|E1|Reported Event|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
77972|NCT01916226|B5|Baseline|Total|Total of all reporting groups
77973|NCT01916226|B4|Baseline|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
77974|NCT01916226|B3|Baseline|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
77975|NCT01916226|B2|Baseline|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
77976|NCT01916226|B1|Baseline|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
77977|NCT01916226|P4|Participant Flow|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
77978|NCT01916226|P3|Participant Flow|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
77979|NCT01916226|P2|Participant Flow|Cetirizine 10 mg|Participants self-administered a 10 milligram (mg) cetrizine capsule once daily in the AM for 2 weeks.
78066|NCT01915823|B2|Baseline|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily
Dymista vehicle"
77982|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
77983|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
77984|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
77985|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
77986|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
77987|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
77988|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
77989|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
77990|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
77991|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
77992|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
77993|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
77994|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
77995|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
77996|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
77997|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
77998|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
77999|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
78000|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
78001|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
78002|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
78003|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
78004|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
78005|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
78006|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
78007|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
78008|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks
78009|NCT01916226|E4|Reported Event|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
78010|NCT01916226|E3|Reported Event|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
78011|NCT01916226|E2|Reported Event|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
78012|NCT01916226|E1|Reported Event|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
78013|NCT01916109|B1|Baseline|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
78014|NCT01916109|P1|Participant Flow|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
78015|NCT01916109|O1|Outcome|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
78016|NCT01916109|E1|Reported Event|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
78028|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78482|NCT01912404|E2|Reported Event|Placebo|Matching Placebo capsules twice daily for 28 days
78017|NCT01915914|B1|Baseline|Overall|Participants who entered the Acute Phase received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to the affected sites and any newly occurring atopic dermatitis (AD) sites. The efficacy and safety in the Acute Phase assessed every 2 weeks up to 4 weeks or until treatment success. Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with physician static global assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, participants received emollient BID plus FP 0.05% cream OD twice a week, or emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78018|NCT01915914|P4|Participant Flow|Follow-up: Emollient|Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78019|NCT01915914|P3|Participant Flow|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
78179|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78020|NCT01915914|P2|Participant Flow|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
78021|NCT01915914|P1|Participant Flow|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
78022|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
78023|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78024|NCT01915914|O1|Outcome|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
78025|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
78026|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78027|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
78040|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78029|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
78030|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78180|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78181|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78031|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe).During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78032|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week, up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78033|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks.
78034|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
78035|NCT01915914|O1|Outcome|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
78036|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78037|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78038|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks.
78039|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
78060|NCT01915849|O1|Outcome|LIK066 15 mg|All patients who have received LIK066 15 mg once daily for 4 days.
78061|NCT01915849|E4|Reported Event|LIK066 150 mg|LIK066 150 mg
78062|NCT01915849|E3|Reported Event|LIK066 50 mg|LIK066 50 mg
78063|NCT01915849|E2|Reported Event|LIK066 15 mg|LIK066 15 mg
78064|NCT01915849|E1|Reported Event|Placebo|Placebo
78065|NCT01915823|B3|Baseline|Total|Total of all reporting groups
78041|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78042|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
78182|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78043|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
78044|NCT01915914|E4|Reported Event|Follow-up: Emollient|Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
78045|NCT01915914|E3|Reported Event|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
78046|NCT01915914|E2|Reported Event|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
78047|NCT01915914|E1|Reported Event|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety of FP 0.05% cream was assessed every 2 weeks up to 4 weeks or until treatment success.
78048|NCT01915849|B5|Baseline|Total|Total of all reporting groups
78049|NCT01915849|B4|Baseline|Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg|Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
78050|NCT01915849|B3|Baseline|Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg|Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
78051|NCT01915849|B2|Baseline|Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo|Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
78052|NCT01915849|B1|Baseline|Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg|Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
78053|NCT01915849|P4|Participant Flow|Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg|Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
78054|NCT01915849|P3|Participant Flow|Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg|Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
78055|NCT01915849|P2|Participant Flow|Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo|Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
78056|NCT01915849|P1|Participant Flow|Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg|Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
78057|NCT01915849|O4|Outcome|Placebo|All patients who have received placebo once daily for 4 days.
78058|NCT01915849|O3|Outcome|LIK066 150 mg|All patients who have received LIK066 150 mg once daily for 4 days.
78059|NCT01915849|O2|Outcome|LIK066 50 mg|All patients who have received LIK066 50 mg once daily for 4 days.
78067|NCT01915823|B1|Baseline|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray
Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily
azelastine hydrochloride and fluticasone propionate"
78068|NCT01915823|P2|Participant Flow|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily
Dymista vehicle"
78069|NCT01915823|P1|Participant Flow|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray
Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily
azelastine hydrochloride and fluticasone propionate"
78070|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily
Dymista vehicle"
78101|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78071|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray
Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily
azelastine hydrochloride and fluticasone propionate"
78072|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily
Dymista vehicle"
78073|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray
Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily
azelastine hydrochloride and fluticasone propionate"
78074|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily
Dymista vehicle"
78075|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray
Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily
azelastine hydrochloride and fluticasone propionate"
78076|NCT01915823|E2|Reported Event|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily
Dymista vehicle"
78077|NCT01915823|E1|Reported Event|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray
Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily
azelastine hydrochloride and fluticasone propionate"
78078|NCT01915732|B3|Baseline|Total|Total of all reporting groups
78079|NCT01915732|B2|Baseline|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78080|NCT01915732|B1|Baseline|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78081|NCT01915732|P2|Participant Flow|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78082|NCT01915732|P1|Participant Flow|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78083|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78084|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78085|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78086|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78087|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78088|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78089|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78090|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78091|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78092|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78093|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78094|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78095|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78096|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78164|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78097|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78098|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78099|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78100|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78102|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78103|NCT01915732|E2|Reported Event|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
78104|NCT01915732|E1|Reported Event|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
78105|NCT01915173|B5|Baseline|Total|Total of all reporting groups
78106|NCT01915173|B4|Baseline|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Expanded Interview"
78107|NCT01915173|B3|Baseline|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Expanded Interview"
78108|NCT01915173|B2|Baseline|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Standard Interview"
78109|NCT01915173|B1|Baseline|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Standard Interview"
78110|NCT01915173|P4|Participant Flow|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Expanded Interview"
78111|NCT01915173|P3|Participant Flow|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Standard Interview"
78112|NCT01915173|P2|Participant Flow|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Standard Interview"
78113|NCT01915173|P1|Participant Flow|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Expanded Interview"
78114|NCT01915173|O4|Outcome|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Expanded Interview"
78115|NCT01915173|O3|Outcome|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Expanded Interview"
78116|NCT01915173|O2|Outcome|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Standard Interview"
78117|NCT01915173|O1|Outcome|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Standard Interview"
78118|NCT01915173|O4|Outcome|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Expanded Interview"
78119|NCT01915173|O3|Outcome|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Expanded Interview"
78120|NCT01915173|O2|Outcome|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Standard Interview"
78121|NCT01915173|O1|Outcome|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Standard Interview"
78122|NCT01915173|O4|Outcome|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Expanded Interview"
78123|NCT01915173|O3|Outcome|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Expanded Interview"
78124|NCT01915173|O2|Outcome|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Standard Interview"
78125|NCT01915173|O1|Outcome|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Standard Interview"
78126|NCT01915173|E4|Reported Event|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Expanded Interview"
78127|NCT01915173|E3|Reported Event|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Expanded Interview"
78128|NCT01915173|E2|Reported Event|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Standard Interview"
78129|NCT01915173|E1|Reported Event|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo: Lactose tablets
Standard Interview"
78130|NCT01915108|B5|Baseline|Total|Total of all reporting groups
78165|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78131|NCT01915108|B4|Baseline|Group R1.5|"remifentanil Ce of 1.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78132|NCT01915108|B3|Baseline|Group R1.0|"remifentanil Ce of 1.0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78133|NCT01915108|B2|Baseline|Group R0.5|"remifentanil Ce of 0.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78134|NCT01915108|B1|Baseline|Group R0|remifentanil Ce of 0 ng/ml
78135|NCT01915108|P4|Participant Flow|Group R1.5|"remifentanil Ce of 1.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78136|NCT01915108|P3|Participant Flow|Group R1.0|"remifentanil Ce of 1.0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78137|NCT01915108|P2|Participant Flow|Group R0.5|"remifentanil Ce of 0.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78138|NCT01915108|P1|Participant Flow|Group R0|remifentanil Ce of 0 ng/ml
78139|NCT01915108|O4|Outcome|Group R1.5|"remifentanil Ce of 1.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78140|NCT01915108|O3|Outcome|Group R1.0|"remifentanil Ce of 1.0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78141|NCT01915108|O2|Outcome|Group R0.5|"remifentanil Ce of 0.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78142|NCT01915108|O1|Outcome|Group R0|remifentanil Ce of 0 ng/ml
78143|NCT01915108|E4|Reported Event|Group R1.0|"remifentanil Ce of 1.0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78144|NCT01915108|E3|Reported Event|Group R0.5|"remifentanil Ce of 0.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78145|NCT01915108|E2|Reported Event|Group R1.5|"remifentanil Ce of 1.5 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78146|NCT01915108|E1|Reported Event|Group R0|"remifentanil Ce of 0 ng/ml
Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
78147|NCT01914926|B3|Baseline|Total|Total of all reporting groups
78148|NCT01914926|B2|Baseline|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
78149|NCT01914926|B1|Baseline|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
78150|NCT01914926|P2|Participant Flow|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
78151|NCT01914926|P1|Participant Flow|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
78152|NCT01914926|O2|Outcome|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
78153|NCT01914926|O1|Outcome|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
78154|NCT01914926|E2|Reported Event|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
78155|NCT01914926|E1|Reported Event|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
78156|NCT01914757|B4|Baseline|Total|Total of all reporting groups
78157|NCT01914757|B3|Baseline|Placebo|Placebo administered subcutaneously
78158|NCT01914757|B2|Baseline|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78159|NCT01914757|B1|Baseline|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78160|NCT01914757|P3|Participant Flow|Placebo|Placebo administered subcutaneously
78161|NCT01914757|P2|Participant Flow|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78162|NCT01914757|P1|Participant Flow|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78163|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78166|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78167|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78168|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78169|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78170|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78171|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78172|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78173|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78174|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78175|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78176|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78183|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78184|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78185|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78186|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78187|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78188|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78189|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78190|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78191|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78192|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78193|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78194|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78195|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78196|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78197|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78198|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78199|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78200|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78201|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78202|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78203|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78204|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78205|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78206|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78207|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78208|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78209|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78210|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78211|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78212|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78213|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78214|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78215|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78216|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78217|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78218|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78219|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78220|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78221|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78222|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78223|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78224|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78225|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78226|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78227|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78228|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78229|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
78230|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78231|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78232|NCT01914757|E3|Reported Event|Placebo|Placebo administered subcutaneously
78233|NCT01914757|E2|Reported Event|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
78234|NCT01914757|E1|Reported Event|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
78235|NCT01914679|B1|Baseline|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).
RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
78236|NCT01914679|P1|Participant Flow|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments), and 12 weeks of RINCE therapy (24 treatments).
RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
78237|NCT01914679|O1|Outcome|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).
RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
78238|NCT01914679|E1|Reported Event|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).
RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
78239|NCT01914666|B4|Baseline|Total|Total of all reporting groups
78240|NCT01914666|B3|Baseline|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78241|NCT01914666|B2|Baseline|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78242|NCT01914666|B1|Baseline|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78243|NCT01914666|P3|Participant Flow|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78244|NCT01914666|P2|Participant Flow|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY [NCT#01855919]) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78245|NCT01914666|P1|Participant Flow|Naïve|New participants (Pts) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78246|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78247|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78248|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78249|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78250|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78251|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78252|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78253|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78254|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78255|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78256|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78257|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78258|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78259|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78365|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
78260|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78261|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78262|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78263|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78264|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78265|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78266|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
79435|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
78267|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78268|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78269|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78270|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78271|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78272|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78273|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78274|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78275|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
78276|NCT01914666|E1|Reported Event|Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg)|All participants from Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg) groups combined.
78277|NCT01914003|B3|Baseline|Total|Total of all reporting groups
78278|NCT01914003|B2|Baseline|Control|Individual does not have any known CSID mutations.
78279|NCT01914003|B1|Baseline|CSID Mutations|Individual has one or more known CSID mutations.
78280|NCT01914003|P2|Participant Flow|Control|Individual does not have any known CSID mutations.
78281|NCT01914003|P1|Participant Flow|CSID Mutations|Individual has one or more known CSID mutations.
78282|NCT01914003|O2|Outcome|Control|Individual does not have any known CSID mutations.
78283|NCT01914003|O1|Outcome|CSID Mutations|Individual has one or more known CSID mutations.
78284|NCT01914003|E2|Reported Event|Control|Individual does not have any known CSID mutations.
78285|NCT01914003|E1|Reported Event|CSID Mutations|Individual has one or more known CSID mutations.
78286|NCT01913795|B5|Baseline|Total|Total of all reporting groups
78287|NCT01913795|B4|Baseline|Sham and IPM|"classroom sham air purifiers and school integrated pest management
integrated pest management: integrated pest management and environmental strategy"
78288|NCT01913795|B3|Baseline|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers"
78289|NCT01913795|B2|Baseline|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
78290|NCT01913795|B1|Baseline|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers"
78291|NCT01913795|P4|Participant Flow|Sham and IPM|"classroom sham air purifiers and school integrated pest management
integrated pest management: integrated pest management and environmental strategy"
78292|NCT01913795|P3|Participant Flow|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers"
78293|NCT01913795|P2|Participant Flow|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
78294|NCT01913795|P1|Participant Flow|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers"
78295|NCT01913795|O4|Outcome|Sham and IPM|"5 subjects
classroom sham air purifiers and school integrated pest management
integrated pest management: integrated pest management and environmental strategy"
78296|NCT01913795|O3|Outcome|Air Purifier and no IPM|"9 subjects
air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers"
78297|NCT01913795|O2|Outcome|Sham and no IPM|"7 subjects
sham air purifiers and no school integrated pest management environmental intervention"
78298|NCT01913795|O1|Outcome|Air Purifier + IPM|"4 subjects
classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers"
78299|NCT01913795|O4|Outcome|Sham and IPM|"5 subjects
classroom sham air purifiers and school integrated pest management
integrated pest management: integrated pest management and environmental strategy"
78300|NCT01913795|O3|Outcome|Air Purifier and no IPM|"9 subjects
air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers"
78301|NCT01913795|O2|Outcome|Sham and no IPM|"7 subjects
sham air purifiers and no school integrated pest management environmental intervention"
78302|NCT01913795|O1|Outcome|Air Purifier + IPM|"4 subjects
classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers"
78303|NCT01913795|E4|Reported Event|Sham and IPM|"classroom sham air purifiers and school integrated pest management
integrated pest management: integrated pest management and environmental strategy"
78304|NCT01913795|E3|Reported Event|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention
air purifier: air purifiers"
78305|NCT01913795|E2|Reported Event|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
78306|NCT01913795|E1|Reported Event|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention
integrated pest management: integrated pest management and environmental strategy
air purifier: air purifiers"
78307|NCT01913535|B6|Baseline|Total|Total of all reporting groups
78308|NCT01913535|B5|Baseline|Placebo/Placebo Arm|Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
78309|NCT01913535|B4|Baseline|Placebo/High-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2)
CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
78310|NCT01913535|B3|Baseline|Placebo/Low-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2)
CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days)."
78311|NCT01913535|B2|Baseline|High Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
78312|NCT01913535|B1|Baseline|Low Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days)."
78313|NCT01913535|P5|Participant Flow|Placebo/Placebo Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
Placebo: For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days)."
78314|NCT01913535|P4|Participant Flow|Placebo/High-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2)
CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
78315|NCT01913535|P3|Participant Flow|Placebo/Low-Dose Drug Arm|"Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2)
CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).
For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days."
78316|NCT01913535|P2|Participant Flow|High Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days)."
78317|NCT01913535|P1|Participant Flow|Low Dose Drug-Drug Arm|"Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days)."
78318|NCT01913535|O2|Outcome|Placebo|"Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
78319|NCT01913535|O1|Outcome|CERC-501|"either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
78320|NCT01913535|O2|Outcome|Placebo|"Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
78321|NCT01913535|O1|Outcome|CERC-501|"either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
78322|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
78323|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
78324|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: placebo-placebo arm only"
78325|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: either dose drug-drug arms only"
78386|NCT01912781|B2|Baseline|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78387|NCT01912781|B1|Baseline|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78326|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: placebo-placebo arm only"
78327|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: either dose drug-drug arms only"
78328|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: placebo-placebo arm only"
78329|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: either dose drug-drug arms only"
78330|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: placebo-placebo arm only"
78331|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: either dose drug-drug arms only"
78332|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: placebo-placebo arm only"
78333|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: either dose drug-drug arms only"
78334|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: placebo-placebo arm only"
78335|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: either dose drug-drug arms only"
78336|NCT01913535|O2|Outcome|Placebo|"For time frame through 72 hours: Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: placebo-placebo arm only"
78337|NCT01913535|O1|Outcome|CERC-501|"For time frame through 72 hours: either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
For 20-day time frame: either dose drug-drug arms only"
78366|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
78338|NCT01913535|O2|Outcome|Placebo|"Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
78339|NCT01913535|O1|Outcome|CERC-501|"either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
78340|NCT01913535|O2|Outcome|Placebo|Placebo therapy in placebo-placebo arm
78341|NCT01913535|O1|Outcome|CERC-501|either dose (10 mg/day or 20 mg/day) of CERC-501 in drug-drug arms
78342|NCT01913535|O2|Outcome|Placebo|"Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
78343|NCT01913535|O1|Outcome|CERC-501|"either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3."
78344|NCT01913535|E3|Reported Event|Placebo|Patients receive placebo
78345|NCT01913535|E2|Reported Event|High Dose Drug|Patients receive CERC-501 20.0 mg/day
78346|NCT01913535|E1|Reported Event|Low Dose Drug|Patients receive CERC-501 10.0 mg/day
78347|NCT01913483|B3|Baseline|Total|Total of all reporting groups
78348|NCT01913483|B2|Baseline|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
78349|NCT01913483|B1|Baseline|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
78350|NCT01913483|P2|Participant Flow|Unfractionated Heparin|Unfractionated heparin (UFH) was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
78351|NCT01913483|P1|Participant Flow|Bivalirudin|Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram [kg]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate [eGFR] <30 milliliters per minute [mL/min]).
78352|NCT01913483|O2|Outcome|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
78353|NCT01913483|O1|Outcome|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
78354|NCT01913483|O2|Outcome|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
78355|NCT01913483|O1|Outcome|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
78356|NCT01913483|O2|Outcome|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
78357|NCT01913483|O1|Outcome|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
78358|NCT01913483|E2|Reported Event|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
78359|NCT01913483|E1|Reported Event|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
78360|NCT01913470|B3|Baseline|Total|Total of all reporting groups
78361|NCT01913470|B2|Baseline|Placebo Followed by Losartan|Recipients of treatment with a placebo for 8 weeks followed by 8 weeks of treatment with losartan.
78362|NCT01913470|B1|Baseline|Losartan Followed by Placebo|Recipients of treatment with losartan for 8 weeks followed by 8 weeks of treatment with a placebo.
78363|NCT01913470|P2|Participant Flow|Placebo Followed by Losartan|Recipients of treatment with a placebo for 8 weeks followed by 8 weeks of treatment with losartan.
78364|NCT01913470|P1|Participant Flow|Losartan Followed by Placebo|Recipients of treatment with losartan for 8 weeks followed by 8 weeks of treatment with a placebo
78381|NCT01913041|B1|Baseline|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
78382|NCT01913041|P1|Participant Flow|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
78383|NCT01913041|O1|Outcome|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
78384|NCT01913041|E1|Reported Event|Observation Group|There is only one group, The main purpose of this investigation is to observe the hypothermia rate in elective operations under general anaesthesia in Peking in China.
78385|NCT01912781|B3|Baseline|Total|Total of all reporting groups
78388|NCT01912781|P2|Participant Flow|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78389|NCT01912781|P1|Participant Flow|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78390|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78391|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78392|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78393|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78394|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78395|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78396|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78397|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78398|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78399|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78400|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78401|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78402|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78403|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78404|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78405|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78406|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78407|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78408|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78409|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78410|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78411|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78412|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78413|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
78414|NCT01912781|E3|Reported Event|Boston Simplus|All subjects who were exposed to Boston Simplus
78415|NCT01912781|E2|Reported Event|FID 120974A|All subjects who were exposed to FID 120947A
78416|NCT01912781|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
78417|NCT01912768|B3|Baseline|Total|Total of all reporting groups
78418|NCT01912768|B2|Baseline|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78419|NCT01912768|B1|Baseline|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78420|NCT01912768|P2|Participant Flow|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78421|NCT01912768|P1|Participant Flow|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78422|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78423|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78424|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78425|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78426|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78427|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78428|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78429|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78430|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78431|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78432|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78433|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78434|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78435|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78436|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78437|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78438|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78439|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78440|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78441|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78442|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78443|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78444|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78445|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
78446|NCT01912768|E3|Reported Event|Renu Fresh|All subjects who were exposed to renu fresh
78447|NCT01912768|E2|Reported Event|FID 120947A|All subjects who were exposed to FID 120947A
78448|NCT01912768|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
78449|NCT01912599|B3|Baseline|Total|Total of all reporting groups
78450|NCT01912599|B2|Baseline|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78451|NCT01912599|B1|Baseline|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78452|NCT01912599|P2|Participant Flow|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78483|NCT01912404|E1|Reported Event|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
78484|NCT01912352|B1|Baseline|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
79399|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
78453|NCT01912599|P1|Participant Flow|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78528|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
78529|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
78612|NCT01911442|B1|Baseline|Lurasidone 20 mg Once Daily|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
78454|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78455|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78456|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78457|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78458|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78459|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78485|NCT01912352|P1|Participant Flow|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
78486|NCT01912352|O1|Outcome|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
78487|NCT01912352|O1|Outcome|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
78460|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78461|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78462|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78463|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78464|NCT01912599|E2|Reported Event|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78465|NCT01912599|E1|Reported Event|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.
Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
78466|NCT01912495|B1|Baseline|Boceprevir/Peginterferon/Ribavirin|Boceprevir with Peginterferon and Ribavirin
78467|NCT01912495|P1|Participant Flow|Boceprevir|12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
78468|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week boceprevir, peginterferon and ribavirin in intention to treat group
78469|NCT01912495|O1|Outcome|Boceprevir Peginterferon Ribavirin|Boceprevir peginterferon and ribavirin
78470|NCT01912495|O1|Outcome|Boceprevir Peginterferon Ribavirin|12 week Boceprevir peginterferon and ribavirin
78471|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week Boceprevir, Peginterferon and Ribavirin
78472|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week boceprevir, peginterferon and ribavirin in intention to treat group
78473|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week Boceprevir, Peginterferon and Ribavirin
78474|NCT01912495|E1|Reported Event|Boceprevir|12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
78475|NCT01912404|B3|Baseline|Total|Total of all reporting groups
78476|NCT01912404|B2|Baseline|Placebo|Matching Placebo capsules twice daily for 28 days
78477|NCT01912404|B1|Baseline|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
78478|NCT01912404|P2|Participant Flow|Placebo|Matching Placebo capsules twice daily for 28 days
78479|NCT01912404|P1|Participant Flow|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
78488|NCT01912352|E1|Reported Event|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
78489|NCT01912339|B3|Baseline|Total|Total of all reporting groups
78490|NCT01912339|B2|Baseline|Control|"Control: Rigid Cystoscopy
Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
78530|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
78613|NCT01911442|P3|Participant Flow|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
78491|NCT01912339|B1|Baseline|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
78492|NCT01912339|P3|Participant Flow|Crossover of Control Subjects|Subjects randomized to the control group will be offered the option to receive the Rezum treatment after the 3 month follow-up visit evaluations are completed. Subjects must decide to cross over by the end of the 6 month follow-up visit.
78493|NCT01912339|P2|Participant Flow|Control|"Control: Rigid Cystoscopy
Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
78494|NCT01912339|P1|Participant Flow|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
78495|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy
Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
78496|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
78497|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy
Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
78498|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
78499|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy
Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
78500|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
78501|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy
Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
78502|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
78503|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy
Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
78526|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
78527|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
79400|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
78531|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
78667|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78504|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
78505|NCT01912339|E2|Reported Event|Control|"Control: Rigid Cystoscopy
Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
78506|NCT01912339|E1|Reported Event|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
78507|NCT01912222|B4|Baseline|Total|Total of all reporting groups
78508|NCT01912222|B3|Baseline|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
78509|NCT01912222|B2|Baseline|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
78510|NCT01912222|B1|Baseline|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
78511|NCT01912222|P3|Participant Flow|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
78512|NCT01912222|P2|Participant Flow|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
78513|NCT01912222|P1|Participant Flow|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
78514|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
78515|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
78516|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
78517|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
78518|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
78519|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
78520|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
78521|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
78522|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
78523|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
78524|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
78525|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
78650|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78532|NCT01912222|E3|Reported Event|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
78533|NCT01912222|E2|Reported Event|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
78534|NCT01912222|E1|Reported Event|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
78535|NCT01911845|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
78536|NCT01911845|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
78537|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
78538|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
78539|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
78540|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
78541|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
78542|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
78543|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
78544|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
78545|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
78546|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
78547|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
78548|NCT01911845|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
78549|NCT01911793|B3|Baseline|Total|Total of all reporting groups
78550|NCT01911793|B2|Baseline|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
78551|NCT01911793|B1|Baseline|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
78552|NCT01911793|P2|Participant Flow|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
78553|NCT01911793|P1|Participant Flow|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
78554|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
78555|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
78651|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily"
79401|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
78556|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
78557|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
78558|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
78559|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
78560|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
78561|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
78562|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
78563|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
78564|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
78565|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
78566|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
78567|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
78568|NCT01911793|O2|Outcome|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
78569|NCT01911793|O1|Outcome|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
78570|NCT01911793|E2|Reported Event|Standard Stoma|Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
78571|NCT01911793|E1|Reported Event|Stoma Tube|"Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group."
78572|NCT01911780|B3|Baseline|Total|Total of all reporting groups
78573|NCT01911780|B2|Baseline|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78574|NCT01911780|B1|Baseline|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78575|NCT01911780|P2|Participant Flow|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78576|NCT01911780|P1|Participant Flow|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78577|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo + Ext|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78578|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine + Ext|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78579|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo + Ext|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78652|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78653|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78580|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine + Ext|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78581|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78582|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78583|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78584|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78585|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78586|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78587|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78588|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
78589|NCT01911780|E4|Reported Event|Telmisartan + HCTZ + Placebo - Extension Period|Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks in the double-blind period. Adverse events which occurred in extension period were collected.
78590|NCT01911780|E3|Reported Event|Telmisartan + HCTZ + Amlodipine - Extension Period|Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks in the double blind period. Adverse events which occurred in extension period were collected.
78591|NCT01911780|E2|Reported Event|Telmisartan + HCTZ + Placebo - Double Blind Period|Telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks (double-blind period)
78592|NCT01911780|E1|Reported Event|Telmisartan + HCTZ + Amlodipine - Double Blind Period|Telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks (double blind period)
78593|NCT01911689|B3|Baseline|Total|Total of all reporting groups
78594|NCT01911689|B2|Baseline|Controlgroup|All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position.
78595|NCT01911689|B1|Baseline|Acute Pancreatitis|All AP patients underwent the MRI scan within three days after admission. All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position.
78596|NCT01911689|P2|Participant Flow|Controlgroup|normal control group：without pancreatic disorders.The exclusion criteria in this study were as follows: (a) inability to cooperate when MR imaging was performed; (b) a history of chronic pancreatitis; (c) AP due to pancreatic carcinoma; (d) hypoproteinemia; and (e) with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;(f) with iron deposition disorder (e.g. diabetes or blood system diseases).
78597|NCT01911689|P1|Participant Flow|Acute Pancreatitis|acute pancreatitis group：(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination.
78598|NCT01911689|O2|Outcome|Severe AP|Severe AP was graded as the Apache II score ≥8 points.
78599|NCT01911689|O1|Outcome|Mild AP|Mild AP was graded as the Apache II score ＜ 7 points.
78600|NCT01911689|O3|Outcome|Severe AP|Severe AP was defined as 7-10 points according to MRSI.
78601|NCT01911689|O2|Outcome|Moderate AP|Moderate AP was defined as 4-6 points according to MRSI.
78602|NCT01911689|O1|Outcome|Mild AP|Mild AP was defined as 0-3 points according to MRSI.
78603|NCT01911689|O2|Outcome|Necrotizing AP|T2* value of necrotizing AP
78604|NCT01911689|O1|Outcome|Edematous AP|T2* value of edematous AP
78605|NCT01911689|O2|Outcome|Control Group|T2* value of control group is mean T2* values of the head, body and tail of pancreas respectively.The control group:without pancreatic disorders
78654|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily"
78655|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78656|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78606|NCT01911689|O1|Outcome|Acute Pancreatitis|T2* value of AP group is mean T2* values of the head, body and tail of pancreas respectively (If AP with necrosis, measureing the corresponding to the area with no necrosis).The AP group:(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination
78607|NCT01911689|E2|Reported Event|Controlgroup|Not Including Serious
78608|NCT01911689|E1|Reported Event|Acute Pancreatitis|Not Including Serious
78609|NCT01911442|B4|Baseline|Total|Total of all reporting groups
78610|NCT01911442|B3|Baseline|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
78611|NCT01911442|B2|Baseline|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
78614|NCT01911442|P2|Participant Flow|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
78615|NCT01911442|P1|Participant Flow|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
78616|NCT01911442|O3|Outcome|Placebo|"Placebo once daily
Placebo: Placebo"
78617|NCT01911442|O2|Outcome|Lurasidone 60 mg|"Lurasidone 60 mg once daily
Lurasidone: Lurasidone 60 mg once daily"
78618|NCT01911442|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily
Lurasidone 20 mg daily: Lurasidone 20 mg once daily"
78619|NCT01911442|O3|Outcome|Placebo|"Placebo once daily
Placebo: Placebo"
78620|NCT01911442|O2|Outcome|Lurasidone 60 mg|"Lurasidone 60 mg once daily
Lurasidone: Lurasidone 60 mg once daily"
78621|NCT01911442|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily
Lurasidone 20 mg daily: Lurasidone 20 mg once daily"
78622|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
78623|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
78624|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
78625|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
78626|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
78627|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
78628|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
78629|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
78630|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
78631|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
78632|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
78633|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
78634|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
78635|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
78636|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
78637|NCT01911442|E3|Reported Event|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
78638|NCT01911442|E2|Reported Event|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
78639|NCT01911442|E1|Reported Event|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
78640|NCT01911429|B4|Baseline|Total|Total of all reporting groups
78641|NCT01911429|B3|Baseline|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78642|NCT01911429|B2|Baseline|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily"
78643|NCT01911429|B1|Baseline|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78644|NCT01911429|P3|Participant Flow|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78645|NCT01911429|P2|Participant Flow|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily Subjects received lurasidone 40/mg day from Days 1-3, and 80mg/day from days 4 to Week 6 visit"
78646|NCT01911429|P1|Participant Flow|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78647|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78648|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily"
78649|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78657|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily"
78658|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78659|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78660|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily"
78661|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78662|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78663|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily"
78664|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78665|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78666|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily"
79436|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
78668|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78669|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily"
78670|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78671|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78672|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily"
78673|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78674|NCT01911429|E3|Reported Event|Placebo|"Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
78675|NCT01911429|E2|Reported Event|Lurasidone 80 mg|"Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily"
78676|NCT01911429|E1|Reported Event|Lurasidone 40 mg|"Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily"
78677|NCT01911403|B3|Baseline|Total|Total of all reporting groups
78678|NCT01911403|B2|Baseline|Manual Compression|"Closure procedure by manual compression
Manual compression: Closure procedure by Manual compression"
78679|NCT01911403|B1|Baseline|Angio-Seal|"Closure procedure by Angio-Seal
Angio-Seal: Closure procedure by angio-Seal"
78680|NCT01911403|P2|Participant Flow|Manual Compression|"Closure procedure by manual compression
Manual compression: Closure procedure by Manual compression"
78681|NCT01911403|P1|Participant Flow|Angio-Seal|"Closure procedure by Angio-Seal
Angio-Seal: Closure procedure by angio-Seal"
78682|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal
Angio-Seal: Closure procedure by angio-Seal"
78683|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression
Manual compression: Closure procedure by Manual compression"
78684|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal
Angio-Seal: Closure procedure by angio-Seal"
78685|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression
Manual compression: Closure procedure by Manual compression"
78686|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal
Angio-Seal: Closure procedure by angio-Seal"
78687|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression
Manual compression: Closure procedure by Manual compression"
78688|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal
Angio-Seal: Closure procedure by angio-Seal"
78689|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression
Manual compression: Closure procedure by Manual compression"
78690|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal
Angio-Seal: Closure procedure by angio-Seal"
78691|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression
Manual compression: Closure procedure by Manual compression"
78692|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal
Angio-Seal: Closure procedure by angio-Seal"
78693|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression
Manual compression: Closure procedure by Manual compression"
78694|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal
Angio-Seal: Closure procedure by angio-Seal"
78695|NCT01911403|E2|Reported Event|Manual Compression|"Closure procedure by manual compression
Manual compression: Closure procedure by Manual compression"
78696|NCT01911403|E1|Reported Event|Angio-Seal|"Closure procedure by Angio-Seal
Angio-Seal: Closure procedure by angio-Seal"
78697|NCT01911390|B5|Baseline|Total|Total of all reporting groups
78698|NCT01911390|B4|Baseline|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.
Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
78699|NCT01911390|B3|Baseline|Rice Bran|"15 grams rice bran/day in smoothie or muffin.
Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
78700|NCT01911390|B2|Baseline|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.
Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
78701|NCT01911390|B1|Baseline|Control Arm|"No bean or rice bran additive in smoothie or muffin.
Control arm: No bean or rice bran additive in smoothie or muffin."
78702|NCT01911390|P4|Participant Flow|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.
Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
78703|NCT01911390|P3|Participant Flow|Rice Bran|"15 grams rice bran/day in smoothie or muffin.
Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
78704|NCT01911390|P2|Participant Flow|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.
Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
78705|NCT01911390|P1|Participant Flow|Control Arm|"No bean or rice bran additive in smoothie or muffin.
Control arm: No bean or rice bran additive in smoothie or muffin."
78706|NCT01911390|O4|Outcome|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.
Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
78707|NCT01911390|O3|Outcome|Rice Bran|"15 grams rice bran/day in smoothie or muffin.
Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
78708|NCT01911390|O2|Outcome|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.
Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
78709|NCT01911390|O1|Outcome|Control Arm|"No bean or rice bran additive in smoothie or muffin.
Control arm: No bean or rice bran additive in smoothie or muffin."
79011|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
78710|NCT01911390|O4|Outcome|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.
Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
78711|NCT01911390|O3|Outcome|Rice Bran|"15 grams rice bran/day in smoothie or muffin.
Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
78712|NCT01911390|O2|Outcome|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.
Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
78713|NCT01911390|O1|Outcome|Control Arm|"No bean or rice bran additive in smoothie or muffin.
Control arm: No bean or rice bran additive in smoothie or muffin."
78714|NCT01911390|E4|Reported Event|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.
Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
78715|NCT01911390|E3|Reported Event|Rice Bran|"15 grams rice bran/day in smoothie or muffin.
Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
78716|NCT01911390|E2|Reported Event|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.
Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
78717|NCT01911390|E1|Reported Event|Control Arm|"No bean or rice bran additive in smoothie or muffin.
Control arm: No bean or rice bran additive in smoothie or muffin."
78718|NCT01911351|B3|Baseline|Total|Total of all reporting groups
78719|NCT01911351|B2|Baseline|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.
Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
78720|NCT01911351|B1|Baseline|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
78721|NCT01911351|P2|Participant Flow|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.
Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
78722|NCT01911351|P1|Participant Flow|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
78723|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.
Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
78724|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
78725|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.
Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
78726|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
78727|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.
Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
78728|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
78729|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.
Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
78730|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
78731|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.
Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
78732|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
78733|NCT01911351|E2|Reported Event|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.
Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
78734|NCT01911351|E1|Reported Event|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
78735|NCT01911273|B3|Baseline|Total|Total of all reporting groups
79001|NCT01910116|P1|Participant Flow|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
Shinbaro"
78736|NCT01911273|B2|Baseline|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78737|NCT01911273|B1|Baseline|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78738|NCT01911273|P2|Participant Flow|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78739|NCT01911273|P1|Participant Flow|PF-03446962 Plus BSC|PF-03446962 7 milligram per kilogram (mg/kg) was administered intravenously (IV) as 1-hour infusion every two weeks (q2w) plus BSC
78740|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78741|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78742|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78743|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78744|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78745|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78746|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78747|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78748|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78749|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78750|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78751|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78752|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78753|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78754|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78755|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78756|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78757|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78758|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78759|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78760|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78761|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78762|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78763|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78764|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78765|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78766|NCT01911273|E2|Reported Event|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
78767|NCT01911273|E1|Reported Event|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
78768|NCT01911260|B5|Baseline|Total|Total of all reporting groups
78806|NCT01911065|O2|Outcome|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
78769|NCT01911260|B4|Baseline|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78770|NCT01911260|B3|Baseline|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78771|NCT01911260|B2|Baseline|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78772|NCT01911260|B1|Baseline|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78773|NCT01911260|P4|Participant Flow|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78774|NCT01911260|P3|Participant Flow|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78775|NCT01911260|P2|Participant Flow|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78776|NCT01911260|P1|Participant Flow|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78777|NCT01911260|O4|Outcome|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78778|NCT01911260|O3|Outcome|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78779|NCT01911260|O2|Outcome|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78780|NCT01911260|O1|Outcome|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78810|NCT01910831|B1|Baseline|All Participants|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
79012|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
78781|NCT01911260|E4|Reported Event|Normal Height Receiving Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78782|NCT01911260|E3|Reported Event|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78783|NCT01911260|E2|Reported Event|Growth Deficit Receiving Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78784|NCT01911260|E1|Reported Event|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).
During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
78785|NCT01911221|B1|Baseline|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
78786|NCT01911221|P1|Participant Flow|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
78787|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
78788|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
78789|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
78790|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
78791|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
78792|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
78793|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
78794|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
78795|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
78796|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
78797|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
78798|NCT01911221|E1|Reported Event|rMenB+OMVNZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
78799|NCT01911065|B3|Baseline|Total|Total of all reporting groups
78800|NCT01911065|B2|Baseline|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
78801|NCT01911065|B1|Baseline|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
78802|NCT01911065|P2|Participant Flow|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
78803|NCT01911065|P1|Participant Flow|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
78804|NCT01911065|O2|Outcome|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
78805|NCT01911065|O1|Outcome|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
78807|NCT01911065|O1|Outcome|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
78808|NCT01911065|E2|Reported Event|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
78809|NCT01911065|E1|Reported Event|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
78858|NCT01910402|B2|Baseline|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78811|NCT01910831|P1|Participant Flow|DerMend Moisturizing Bruise Formula vs. Vehicle Control|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
DerMend Moisturizing Bruise Formula vs. Vehicle control."
78812|NCT01910831|O2|Outcome|LEFT Arm Randomized to Non-active Placebo Control|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
78813|NCT01910831|O1|Outcome|LEFT Arm Randomized to DerMend Moisturizing Bruise Formula|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
DerMend Moisturizing Bruise Formula"
78814|NCT01910831|O2|Outcome|LEFT Arm Randomized to Non-active Placebo Control|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
78815|NCT01910831|O1|Outcome|LEFT Arm Randomized to DerMend Moisturizing Bruise Formula|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
DerMend Moisturizing Bruise Formula"
78816|NCT01910831|E1|Reported Event|All Participants|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
78817|NCT01910792|B3|Baseline|Total|Total of all reporting groups
78818|NCT01910792|B2|Baseline|Group 1|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
78819|NCT01910792|B1|Baseline|Group 2|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
78820|NCT01910792|P2|Participant Flow|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
78821|NCT01910792|P1|Participant Flow|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
78822|NCT01910792|O2|Outcome|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
78823|NCT01910792|O1|Outcome|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
78824|NCT01910792|E2|Reported Event|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
78825|NCT01910792|E1|Reported Event|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
78826|NCT01910688|B1|Baseline|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.
RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
78827|NCT01910688|P1|Participant Flow|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.
RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
78851|NCT01910441|P2|Participant Flow|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
78852|NCT01910441|P1|Participant Flow|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
79002|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
78828|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.
RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
78829|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.
RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
78830|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.
RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
78831|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.
RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
78832|NCT01910688|E1|Reported Event|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.
RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
78833|NCT01910636|B3|Baseline|Total|Total of all reporting groups
78834|NCT01910636|B2|Baseline|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
78835|NCT01910636|B1|Baseline|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
78836|NCT01910636|P2|Participant Flow|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
78837|NCT01910636|P1|Participant Flow|SOF+RBV Treatment Naive|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
78838|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
78839|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
78840|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
78841|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
78842|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
78843|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
78844|NCT01910636|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
78845|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
78846|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
78847|NCT01910636|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
78848|NCT01910441|B3|Baseline|Total|Total of all reporting groups
78849|NCT01910441|B2|Baseline|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
78850|NCT01910441|B1|Baseline|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
78853|NCT01910441|O2|Outcome|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
78854|NCT01910441|O1|Outcome|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
78855|NCT01910441|E2|Reported Event|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
78856|NCT01910441|E1|Reported Event|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
78857|NCT01910402|B3|Baseline|Total|Total of all reporting groups
78859|NCT01910402|B1|Baseline|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78860|NCT01910402|P2|Participant Flow|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78861|NCT01910402|P1|Participant Flow|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78862|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78863|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78864|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78865|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78866|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78867|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78868|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78869|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78870|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78871|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78872|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78873|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated..
78997|NCT01910116|B3|Baseline|Total|Total of all reporting groups
78874|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78875|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78876|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78877|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78878|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78879|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78880|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78881|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78882|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78883|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78884|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78885|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated..
78886|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78887|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78888|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78889|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78890|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78891|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78998|NCT01910116|B2|Baseline|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
78892|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78893|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78894|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78895|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78896|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78897|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78898|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78899|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78900|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78901|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78902|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78903|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78904|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78905|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78906|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78907|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78908|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78909|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78999|NCT01910116|B1|Baseline|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
78910|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78911|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78912|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78913|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78914|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78915|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78916|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78917|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78918|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78919|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78920|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78921|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78922|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78923|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it wasi) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78924|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78925|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
78926|NCT01910402|E2|Reported Event|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
78927|NCT01910402|E1|Reported Event|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TD FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TD FDC was discontinued/terminated.
78928|NCT01910389|B3|Baseline|Total|Total of all reporting groups
78929|NCT01910389|B2|Baseline|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78930|NCT01910389|B1|Baseline|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78931|NCT01910389|P2|Participant Flow|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78932|NCT01910389|P1|Participant Flow|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78933|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78934|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78935|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78936|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78937|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78938|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78939|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78940|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78941|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78942|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78943|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78944|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78945|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78946|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78947|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78948|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78949|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78950|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78951|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78952|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78953|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78954|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78955|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78956|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78957|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78958|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
78959|NCT01910389|E2|Reported Event|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
78960|NCT01910389|E1|Reported Event|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
79007|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79008|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
78961|NCT01910311|B1|Baseline|Baricitinib Then Baricitinib and Rifampicin|"Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10."
78962|NCT01910311|P1|Participant Flow|Baricitinib Then Baricitinib and Rifampicin|"Period 1: 10-milligram (mg) dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally once daily (QD) on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10."
78963|NCT01910311|O2|Outcome|Baricitinib and Rifampicin|Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
78964|NCT01910311|O1|Outcome|Baricitinib|Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
78965|NCT01910311|O2|Outcome|Baricitinib and Rifampicin|Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with a coadministration of 10-mg dose of baricitinib on Day 10.
78966|NCT01910311|O1|Outcome|Baricitinib|Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
78967|NCT01910311|O2|Outcome|Baricitinib and Rifampicin|Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
78968|NCT01910311|O1|Outcome|Baricitinib|Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
78969|NCT01910311|E3|Reported Event|Baricitinib and Rifampicin|"A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 10 and 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
AEs are reported postdose on Day 10 up to Day 32."
78970|NCT01910311|E2|Reported Event|Rifampicin|"A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 9.
AEs are reported postdose on Day 3 through predose on Day 10."
78971|NCT01910311|E1|Reported Event|Baricitinib|"A 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
Adverse events (AEs) are reported from baseline through predose on Day 3."
78972|NCT01910181|B1|Baseline|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
78973|NCT01910181|P1|Participant Flow|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 milligrams (mg) twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The Pharmacokinetic (PK) Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
78974|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
78975|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
78976|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
78977|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
78978|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
79000|NCT01910116|P2|Participant Flow|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
Placebo"
78979|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
79009|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79010|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
78980|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
78981|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78982|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78983|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78984|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78985|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78986|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78987|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78988|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78989|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78990|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78991|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78992|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78993|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78994|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78995|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
78996|NCT01910181|E1|Reported Event|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
79003|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79004|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79005|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79006|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79013|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79014|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79015|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79016|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79017|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79018|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79019|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79020|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79021|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79022|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79023|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79024|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79025|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79026|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79027|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79028|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79029|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79030|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79031|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79032|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79033|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79034|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79035|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79036|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79037|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79038|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79039|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79040|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79041|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79042|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79043|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79044|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79045|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79046|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79047|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79048|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79049|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79050|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79051|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79052|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79053|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79054|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79055|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79056|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79057|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79058|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79059|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79060|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79061|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79062|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79063|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79064|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79065|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79066|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79067|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79068|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79069|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79070|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79071|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79072|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79073|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79074|NCT01910116|E2|Reported Event|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.
observation for 4 weeks"
79075|NCT01910116|E1|Reported Event|Shinbaro|"GCSB-5 (Shinbaro), 2 capsules (300mg), twice daily, for 12 weeks
observation for 4 weeks"
79076|NCT01910064|B1|Baseline|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
79077|NCT01910064|P1|Participant Flow|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
79078|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
79079|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
79080|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
79081|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
79082|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
79083|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
79084|NCT01910064|E1|Reported Event|GK530G|GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
79085|NCT01909804|B13|Baseline|Total|Total of all reporting groups
79086|NCT01909804|B12|Baseline|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
79087|NCT01909804|B11|Baseline|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
79088|NCT01909804|B10|Baseline|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
79089|NCT01909804|B9|Baseline|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
79090|NCT01909804|B8|Baseline|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
79091|NCT01909804|B7|Baseline|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
79092|NCT01909804|B6|Baseline|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
79093|NCT01909804|B5|Baseline|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
79094|NCT01909804|B4|Baseline|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
79095|NCT01909804|B3|Baseline|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
79096|NCT01909804|B2|Baseline|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
79097|NCT01909804|B1|Baseline|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
79098|NCT01909804|P12|Participant Flow|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
79099|NCT01909804|P11|Participant Flow|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
79100|NCT01909804|P10|Participant Flow|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
79101|NCT01909804|P9|Participant Flow|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
79102|NCT01909804|P8|Participant Flow|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
79103|NCT01909804|P7|Participant Flow|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
79104|NCT01909804|P6|Participant Flow|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
79105|NCT01909804|P5|Participant Flow|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
79106|NCT01909804|P4|Participant Flow|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
79107|NCT01909804|P3|Participant Flow|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
79108|NCT01909804|P2|Participant Flow|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
79109|NCT01909804|P1|Participant Flow|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|Sofosbuvir (SOF) 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
79110|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
79111|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
79112|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
79113|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
79114|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
79115|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
79116|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
79117|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
79118|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
79119|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
79120|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
79121|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
79122|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
79123|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
79124|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
79125|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
79126|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
79127|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
79128|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
79129|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
79130|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
79131|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
79132|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
79133|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
79134|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
79135|NCT01909804|O3|Outcome|SOF+VEL 100 mg|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
79136|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
79137|NCT01909804|O1|Outcome|SOF+VEL 25 mg|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
79138|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
79139|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
79140|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
79402|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79141|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
79142|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
79143|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
79144|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
79145|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
79146|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
79437|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79147|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
79148|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
79149|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
79150|NCT01909804|E4|Reported Event|SOF+VEL 100 mg + RBV|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
79151|NCT01909804|E3|Reported Event|SOF+VEL 100 mg|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
79152|NCT01909804|E2|Reported Event|SOF+VEL 25 mg + RBV|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
79153|NCT01909804|E1|Reported Event|SOF+VEL 25 mg|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
79154|NCT01909778|B1|Baseline|All Subjects|"The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg and 240 mg.
A number of 12 entered patients with compensated liver cirrhosis was planned."
79155|NCT01909778|P1|Participant Flow|All Subjects|"The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg first, 240 mg second.
A number of 12 entered patients with compensated liver cirrhosis was planned."
79156|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
79157|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
79158|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
79159|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
79160|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
79161|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
79162|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
79163|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
79164|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
79165|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
79166|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
79167|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
79168|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
79169|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
79170|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
79171|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
79172|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
79173|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
79174|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
79175|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
79176|NCT01909778|E2|Reported Event|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
79177|NCT01909778|E1|Reported Event|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
79178|NCT01909713|B1|Baseline|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.
Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
79179|NCT01909713|P1|Participant Flow|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.
Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
79180|NCT01909713|O6|Outcome|I Liked the Lotion Better Than What I Was Using Before|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22). Subjects were only required to respond to this question if they had used a moisturizer previously.
79181|NCT01909713|O5|Outcome|I Would Keep Using the Lotion|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
79182|NCT01909713|O4|Outcome|The Lotion Made my Skin Feel Soft|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
79267|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79183|NCT01909713|O3|Outcome|The Lotion Spread Easily on my Skin|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
79184|NCT01909713|O2|Outcome|The Lotion Smelled Good|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
79185|NCT01909713|O1|Outcome|I Liked Using the Lotion|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
79186|NCT01909713|O6|Outcome|I Liked the Face Wash Better Than What I Was Using Before|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22). Subjects were only required to respond to this question if they had used a face wash previously.
79187|NCT01909713|O5|Outcome|I Would Keep Using the Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
79188|NCT01909713|O4|Outcome|The Face Wash Rinsed Easily Off my Skin|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
79189|NCT01909713|O3|Outcome|The Face Wash Made my Skin Feel Clean|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
79190|NCT01909713|O2|Outcome|The Face Wash Was Easy to Use|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
79191|NCT01909713|O1|Outcome|I Liked Using the Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
79192|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from week 3.
79193|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3.This arm shows the results from week 1.
79194|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from baseline.
79195|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 3.
79196|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days, TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 1.
79197|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from baseline.
79198|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
79199|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
79200|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
79201|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
79202|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
79203|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
79204|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
79205|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
79412|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79206|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
79207|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
79208|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
79209|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
79210|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
79211|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
79212|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
79213|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
79214|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
79215|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
79216|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
79217|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
79218|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
79219|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
79220|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
79221|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
79222|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
79223|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
79224|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
79225|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
79226|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
79227|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
79228|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
79229|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
79230|NCT01909713|E1|Reported Event|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.
Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
79231|NCT01909674|B3|Baseline|Total|Total of all reporting groups
79232|NCT01909674|B2|Baseline|Nasal Mask|"Initial administration of nasal CPAP mask
Switch CPAP mask type"
79233|NCT01909674|B1|Baseline|Oronasal Mask|"Initial administration of oronasal CPAP mask
Switch CPAP mask type"
79234|NCT01909674|P2|Participant Flow|Nasal Mask|"Initial administration of nasal CPAP mask
Switch CPAP mask type"
79235|NCT01909674|P1|Participant Flow|Oronasal Mask|"Initial administration of oronasal CPAP mask
Switch CPAP mask type"
79236|NCT01909674|O2|Outcome|Total Sleep Time (TST) Oronasal Mask|"Total Sleep Time (TST)
The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode."
79237|NCT01909674|O1|Outcome|Total Sleep Time - Nasal Mask|"Total Sleep Time (TST)
The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode."
79238|NCT01909674|E2|Reported Event|Nasal Mask|"Initial administration of nasal CPAP mask
Switch CPAP mask type"
79239|NCT01909674|E1|Reported Event|Oronasal Mask|"Initial administration of oronasal CPAP mask
Switch CPAP mask type"
79240|NCT01909570|B3|Baseline|Total|Total of all reporting groups
79241|NCT01909570|B2|Baseline|Double Embryo Transfer|Transfer of two fresh embryos
79242|NCT01909570|B1|Baseline|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
79243|NCT01909570|P2|Participant Flow|Double Embryo Transfer|Transfer of two fresh embryos
79244|NCT01909570|P1|Participant Flow|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
79245|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
79246|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
79247|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
79248|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
79249|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
79250|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
79251|NCT01909570|E2|Reported Event|Double Embryo Transfer|Transfer of two fresh embryos
79252|NCT01909570|E1|Reported Event|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
79253|NCT01909466|B1|Baseline|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79254|NCT01909466|P2|Participant Flow|Deltoid/Deltoid|Participants were injected with aripiprazole IM depot 400 mg at the deltoid muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79255|NCT01909466|P1|Participant Flow|Gluteal/Deltoid|Participants were injected with aripiprazole IM depot 400 mg at the gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79256|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79257|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79258|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79259|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79260|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79261|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79262|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79403|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79263|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79264|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79265|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79266|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79268|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79269|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79270|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79271|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79272|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79273|NCT01909466|E1|Reported Event|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
79274|NCT01909336|B4|Baseline|Total|Total of all reporting groups
79275|NCT01909336|B3|Baseline|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|"Group 3: 0.9% Saline in 5% dextrose (intravenous)
0.9% Saline in 5% dextrose: Isotonic Solutions 0.9% Saline in 5% dextrose"
79276|NCT01909336|B2|Baseline|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|"Group 2: 0.45% Saline in 5% dextrose (intravenous)
0.45% Saline in 5% dextrose: Hypotonic Solutions: 0.45% Saline in 5% dextrose"
79277|NCT01909336|B1|Baseline|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|"Group 1: 0.3% Saline in 3.3% dextrose (intravenous)
0.3% Saline in 3.3% dextrose: Hypotonic Solutions: 0.3% Saline in 3.3% dextrose"
79278|NCT01909336|P3|Participant Flow|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
79279|NCT01909336|P2|Participant Flow|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
79280|NCT01909336|P1|Participant Flow|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
79281|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
79282|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
79283|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
79284|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
79285|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
79286|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
79287|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
79288|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
79289|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
79290|NCT01909336|E3|Reported Event|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
79291|NCT01909336|E2|Reported Event|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
79292|NCT01909336|E1|Reported Event|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
79293|NCT01909180|B1|Baseline|Standard of Care Scan|"This is a single arm clinical trial.
Standard of care scan
Investigational Scan"
79294|NCT01909180|P1|Participant Flow|Standard of Care Scan|"This is a single arm clinical trial.
Standard of care scan
Investigational Scan"
79295|NCT01909180|O3|Outcome|Neuro|Subjects receiving Revolution CT Scans of Brain or Spinal Cord
79296|NCT01909180|O2|Outcome|Body/ Extremity|Subject receiving a Revolution CT scan of the body or extremities
79297|NCT01909180|O1|Outcome|Cardiac|Subjects who received a cardiac CT scan
79298|NCT01909180|E1|Reported Event|Standard of Care Scan|"This is a single arm clinical trial.
Standard of care scan
Investigational Scan"
79299|NCT01909141|B3|Baseline|Total|Total of all reporting groups
79337|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
79404|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79405|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79300|NCT01909141|B2|Baseline|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 will received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occured.
transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79413|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79414|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79415|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79301|NCT01909141|B1|Baseline|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79302|NCT01909141|P2|Participant Flow|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79303|NCT01909141|P1|Participant Flow|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79304|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79305|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79306|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79338|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
79339|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
79406|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79307|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79308|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79309|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79310|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79311|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79312|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occured.
transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79313|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 receivde letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was be done for arm 1 for 3 consecutive cycles unless pregnancy occured.
transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was caculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79340|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
79341|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
79407|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79314|NCT01909141|E2|Reported Event|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79315|NCT01909141|E1|Reported Event|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.
induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.
transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
body mass index (BMI) calculation: BMI was calculated.
day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.
serum estradiol (E2) was done on day of hCG administration for all women.
serum progesterone on day 21 was done for all women."
79316|NCT01909011|B3|Baseline|Total|Total of all reporting groups
79317|NCT01909011|B2|Baseline|Sham CES|"The CES sham group will receive sham CES (device off)for 20 minutes 5 times per week for two weeks.
Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks."
79318|NCT01909011|B1|Baseline|Active CES|"The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.
FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks."
79319|NCT01909011|P2|Participant Flow|Sham CES|"The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.
Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks."
79320|NCT01909011|P1|Participant Flow|Active CES|"The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.
FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks."
79321|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
79322|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
79323|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
79324|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
79325|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
79326|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
79327|NCT01909011|E2|Reported Event|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks (placebo period), and after cross-over into open-label phase participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for another two weeks.
79328|NCT01909011|E1|Reported Event|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for four weeks.
79329|NCT01908842|B3|Baseline|Total|Total of all reporting groups
79330|NCT01908842|B2|Baseline|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Generic buprenorphine sublingual tablets (blinded); Days 3 to 14: BNX sublingual film (open-label); Days 15-21: Switch to BNX sublingual tablets (open-label); Day 22: End of study visit
79331|NCT01908842|B1|Baseline|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded); Days 3-14: BNX sublingual tablets (open-label); Days 15-21: Switch to BNX sublingual film (open-label); Day 22: End of study visit
79332|NCT01908842|P2|Participant Flow|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
79333|NCT01908842|P1|Participant Flow|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3 to 14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
79334|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
79335|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
79336|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
79396|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79342|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
79343|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
79344|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
79345|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
79346|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
79347|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
79348|NCT01908842|E2|Reported Event|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
79349|NCT01908842|E1|Reported Event|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
79350|NCT01908803|B3|Baseline|Total|Total of all reporting groups
79351|NCT01908803|B2|Baseline|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
79352|NCT01908803|B1|Baseline|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
79353|NCT01908803|P2|Participant Flow|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
79354|NCT01908803|P1|Participant Flow|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
79355|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
79356|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
79357|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
79358|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
79359|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
79360|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
79361|NCT01908803|E3|Reported Event|CIPRODEX|Includes all subjects administered a dose of CIPRODEX®
79362|NCT01908803|E2|Reported Event|AL-60371/AL-817|Includes all subjects administered a dose of AL-60371/AL-817
79363|NCT01908803|E1|Reported Event|Pre-treatment|Includes all subjects prior to administration of study medication
79364|NCT01908140|B3|Baseline|Total|Total of all reporting groups
79365|NCT01908140|B2|Baseline|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
79366|NCT01908140|B1|Baseline|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
79367|NCT01908140|P2|Participant Flow|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
79368|NCT01908140|P1|Participant Flow|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
79369|NCT01908140|O2|Outcome|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
79370|NCT01908140|O1|Outcome|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
79371|NCT01908140|O2|Outcome|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
79372|NCT01908140|O1|Outcome|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
79373|NCT01908140|E2|Reported Event|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
79374|NCT01908140|E1|Reported Event|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
79375|NCT01908127|B3|Baseline|Total|Total of all reporting groups
79376|NCT01908127|B2|Baseline|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.
In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
79397|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79398|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79377|NCT01908127|B1|Baseline|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.
In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
79416|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79417|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79418|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79419|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79420|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79378|NCT01908127|P2|Participant Flow|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.
In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
79379|NCT01908127|P1|Participant Flow|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.
In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
79380|NCT01908127|O2|Outcome|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.
In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
79381|NCT01908127|O1|Outcome|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.
In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
79382|NCT01908127|O2|Outcome|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.
In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
79383|NCT01908127|O1|Outcome|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.
In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
79384|NCT01908127|E2|Reported Event|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.
In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
79385|NCT01908127|E1|Reported Event|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.
In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
79386|NCT01907906|B3|Baseline|Total|Total of all reporting groups
79387|NCT01907906|B2|Baseline|Arm 2: Untreated WB Then Mirasol-treated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49)
79388|NCT01907906|B1|Baseline|Arm 1: Mirasol-treated WB Then Untreated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
79389|NCT01907906|P2|Participant Flow|Arm 2: Untreated WB Then Mirasol-treated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
79390|NCT01907906|P1|Participant Flow|Arm 1: Mirasol-treated Whole Blood (WB) Then Untreated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, leuko-reduced packed red blood cells (LR-pRBCs) manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
79391|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79392|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79393|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79394|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79395|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79408|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79409|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79410|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79411|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79438|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79439|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79440|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79441|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79442|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79443|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79444|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79445|NCT01907906|O2|Outcome|Untreated Control|Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from untreated WB
79446|NCT01907906|O1|Outcome|Mirasol Treated|Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from Mirasol-treated WB
79447|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79448|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79449|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79450|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79451|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79452|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79453|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79454|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79455|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79456|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79457|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79458|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79459|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79460|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79461|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79462|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79463|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
79464|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
79465|NCT01907906|E2|Reported Event|Untreated Control|LR-pRBCs derived from untreated WB
79466|NCT01907906|E1|Reported Event|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB.
79467|NCT01907854|B3|Baseline|Total|Total of all reporting groups
79468|NCT01907854|B2|Baseline|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
79469|NCT01907854|B1|Baseline|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose
≥1000 mg/day]) + OD sitagliptin placebo tablets."
79470|NCT01907854|P2|Participant Flow|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
79499|NCT01907490|P1|Participant Flow|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
79500|NCT01907490|O1|Outcome|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
79471|NCT01907854|P1|Participant Flow|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose
≥1000 mg/day]) + OD sitagliptin placebo tablets."
79472|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
79473|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose
≥1000 mg/day]) + OD sitagliptin placebo tablets."
79474|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
79475|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose
≥1000 mg/day]) + OD sitagliptin placebo tablets."
79476|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
79477|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose
≥1000 mg/day]) + OD sitagliptin placebo tablets."
79478|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
79479|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose
≥1000 mg/day]) + OD sitagliptin placebo tablets."
79480|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
79481|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose
≥1000 mg/day]) + OD sitagliptin placebo tablets."
79482|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
79483|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose
≥1000 mg/day]) + OD sitagliptin placebo tablets."
79484|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
79485|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose
≥1000 mg/day]) + OD sitagliptin placebo tablets."
79486|NCT01907854|E2|Reported Event|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
79487|NCT01907854|E1|Reported Event|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose
≥1000 mg/day]) + OD sitagliptin placebo tablets."
79488|NCT01907516|B3|Baseline|Total|Total of all reporting groups
79489|NCT01907516|B2|Baseline|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first
79490|NCT01907516|B1|Baseline|Cell Phone-internet First, the Voicemail|Cell phone-internet home glucose reporting system first
79491|NCT01907516|P2|Participant Flow|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first, then cell phone-internet
79492|NCT01907516|P1|Participant Flow|Cell Phone-internet First, Then Voicemail|Cell phone-internet home glucose reporting system first, then voicemail
79493|NCT01907516|O1|Outcome|Total Study Population|All study participants, includes those in cell phone-internet first, then voicemail and voicemail first, then cell phone-internet
79494|NCT01907516|O2|Outcome|Used Voicemail Method|Voicemail first, then cell phone-internet home glucose monitoring system
79495|NCT01907516|O1|Outcome|Used Confidant Method|Cell phone-internet home based glucose monitoring first, then conventional Voicemail system for home glucose reporting
79496|NCT01907516|E2|Reported Event|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first
79497|NCT01907516|E1|Reported Event|Cell Phone-internet First, Then Voicemail|Cell phone-internet home glucose reporting system first
79498|NCT01907490|B1|Baseline|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
79501|NCT01907490|E1|Reported Event|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
79502|NCT01907334|B1|Baseline|All Participants|Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg.
79503|NCT01907334|P2|Participant Flow|Advair and Flovent Diskuses, Then Advair and Advair Diskuses|"On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.
On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
79504|NCT01907334|P1|Participant Flow|Advair and Advair Diskuses, Then Advair and Flovent Diskuses|"On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.
On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
79505|NCT01907334|O1|Outcome|Increase in Airway Resistance After Methacholine|Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg. On each study day after treatment, methacholine challenge was performed to determine provocational concentration of methacholine which caused a 40% increase in resistance at 5 Hz (PC40R5).
79513|NCT01907113|B6|Baseline|Total|Total of all reporting groups
79733|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
79506|NCT01907334|E2|Reported Event|Advair and Flovent Diskuses, Then Advair and Advair Diskuses|"On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.
On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
79507|NCT01907334|E1|Reported Event|Advair and Advair Diskuses, Then Advair and Flovent Diskuses|"On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.
On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
79508|NCT01907321|B1|Baseline|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.
Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.
Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.
Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.
Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
79509|NCT01907321|P1|Participant Flow|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.
Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure. Once sufficient pressure is achieved (participant blowing out into the device) a valve is released, enabling airflow.
Measures performed on all subjects: Capsaicin is a cough-inducing vapor that will be inhaled by participants to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, peak expiratory flow rate, and post-peak plateau phase will be made.
Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Also included is the measure of maximum expiratory pressure. Airflow from the voluntary cough will also be recorded and measured using the spirometric system."
79529|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79530|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79510|NCT01907321|O1|Outcome|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.
Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.
Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.
Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.
Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
79511|NCT01907321|O1|Outcome|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.
Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.
Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.
Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.
Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
79512|NCT01907321|E1|Reported Event|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.
Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.
Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.
Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.
Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
79514|NCT01907113|B5|Baseline|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79515|NCT01907113|B4|Baseline|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79516|NCT01907113|B3|Baseline|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79517|NCT01907113|B2|Baseline|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79518|NCT01907113|B1|Baseline|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79519|NCT01907113|P5|Participant Flow|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79520|NCT01907113|P4|Participant Flow|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79521|NCT01907113|P3|Participant Flow|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79522|NCT01907113|P2|Participant Flow|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79523|NCT01907113|P1|Participant Flow|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79524|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79525|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79526|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79527|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79528|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79531|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79532|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79533|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79534|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79535|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79536|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79537|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79538|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79539|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79540|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79730|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
79541|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79542|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79543|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79544|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79545|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79546|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79547|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79548|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79549|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79550|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79551|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79552|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79553|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79554|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79555|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79674|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79556|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79557|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79558|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79559|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79560|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79561|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79562|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79563|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79564|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79565|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79566|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79567|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79568|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79569|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79570|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79571|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79572|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79573|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79574|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79575|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79576|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79577|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79578|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79579|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79580|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79675|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79581|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79582|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79583|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79584|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79585|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79586|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79587|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79588|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79589|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79590|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79591|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79592|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79593|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79594|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79595|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79596|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79597|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79598|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79599|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79600|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79601|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79602|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79603|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79604|NCT01907113|E5|Reported Event|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
79605|NCT01907113|E4|Reported Event|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79676|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79606|NCT01907113|E3|Reported Event|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79607|NCT01907113|E2|Reported Event|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79608|NCT01907113|E1|Reported Event|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
79609|NCT01906658|B5|Baseline|Total|Total of all reporting groups
79610|NCT01906658|B4|Baseline|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79611|NCT01906658|B3|Baseline|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79612|NCT01906658|B2|Baseline|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79613|NCT01906658|B1|Baseline|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79614|NCT01906658|P4|Participant Flow|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79615|NCT01906658|P3|Participant Flow|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79616|NCT01906658|P2|Participant Flow|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79617|NCT01906658|P1|Participant Flow|Acthar 80 U (1.0 mL) Subcutaneous (SC) Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79618|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79619|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79620|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79621|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79622|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79623|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79624|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79625|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79626|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79627|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79628|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79629|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79630|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79631|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79632|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79633|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79677|NCT01905956|E2|Reported Event|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79634|NCT01906658|E4|Reported Event|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79635|NCT01906658|E3|Reported Event|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79636|NCT01906658|E2|Reported Event|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79637|NCT01906658|E1|Reported Event|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly
Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
79638|NCT01906515|B3|Baseline|Total|Total of all reporting groups
79639|NCT01906515|B2|Baseline|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
79640|NCT01906515|B1|Baseline|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.
Continuous non invasive hemoglobin monitoring arm
Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
79641|NCT01906515|P2|Participant Flow|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
79642|NCT01906515|P1|Participant Flow|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.
Continuous non invasive hemoglobin monitoring arm
continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
79643|NCT01906515|O2|Outcome|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
79644|NCT01906515|O1|Outcome|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.
Continuous non invasive hemoglobin monitoring arm.
Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
79731|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
79645|NCT01906515|O2|Outcome|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
79646|NCT01906515|O1|Outcome|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.
Continuous non invasive hemoglobin monitoring arm
Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
79647|NCT01906515|E2|Reported Event|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
79648|NCT01906515|E1|Reported Event|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.
Continuous non invasive hemoglobin monitoring arm
Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
79649|NCT01906372|B1|Baseline|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel)in refractory PM and DM patients using an open label design for 6 months. Study subjects will self-administer subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week for a period of six months.
79650|NCT01906372|P1|Participant Flow|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel) 80 units (1 ml) twice a week for a period of six months.
79651|NCT01906372|O1|Outcome|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel)in refractory PM and DM patients using an open label design for 6 months. 10 active and refractory PM/DM patients were evaluated over a 15 month period, followed by 6 months of additional follow-up for each subject. Study subjects will self-administer subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week for a period of six months.
79652|NCT01906372|O1|Outcome|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel) in active and refractory PM and DM patients using an open label design for 6 months. Study subjects self-administered subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week subcutaneously for a period of six months.
79653|NCT01906372|E1|Reported Event|Acthar Gel|Acthar Gel (Adrenocorticotropic Hormone Gel)in refractory PM and DM patients using an open label design for 6 months. 10 active and refractory PM/DM patients were evaluated over a 15 month period, followed by 6 months of additional follow-up for each subject. Study subjects will self-administer subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week for a period of six months.
79654|NCT01905956|B3|Baseline|Total|Total of all reporting groups
79655|NCT01905956|B2|Baseline|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79656|NCT01905956|B1|Baseline|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79657|NCT01905956|P2|Participant Flow|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79658|NCT01905956|P1|Participant Flow|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79659|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79660|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79661|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79662|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79663|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79664|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79665|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79666|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79667|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79668|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79669|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79670|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79671|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79672|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79673|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily
Placebo"
79678|NCT01905956|E1|Reported Event|IQP-AK-102|"2 capsules per dose, three times daily
IQP-AK-102"
79679|NCT01905657|B4|Baseline|Total|Total of all reporting groups
79680|NCT01905657|B3|Baseline|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
79681|NCT01905657|B2|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
79682|NCT01905657|B1|Baseline|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
79683|NCT01905657|P3|Participant Flow|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
79684|NCT01905657|P2|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
79685|NCT01905657|P1|Participant Flow|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years.
79686|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
79687|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
79688|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
79689|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
79690|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
79691|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
79732|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
79692|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
79693|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
79694|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
79695|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
79696|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
79697|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
79698|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
79699|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
79700|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
79701|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
79702|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
79703|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
79704|NCT01905657|E3|Reported Event|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
79705|NCT01905657|E2|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
79706|NCT01905657|E1|Reported Event|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
79707|NCT01905553|B3|Baseline|Total|Total of all reporting groups
79708|NCT01905553|B2|Baseline|SSP-004184SS Fasted First|Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
79709|NCT01905553|B1|Baseline|SSP-004184SS Fed First|Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
79710|NCT01905553|P2|Participant Flow|SSP-004184SS Fasted First|Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
79711|NCT01905553|P1|Participant Flow|SSP-004184SS Fed First|Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
79712|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
79713|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
79714|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
79715|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
79716|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
79717|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
79718|NCT01905553|E2|Reported Event|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
79719|NCT01905553|E1|Reported Event|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
79720|NCT01905540|B5|Baseline|Total|Total of all reporting groups
79721|NCT01905540|B4|Baseline|SS-AQ-SS2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
79722|NCT01905540|B3|Baseline|SS-AQ-AQ2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
79723|NCT01905540|B2|Baseline|AQ-SS-SS2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
79724|NCT01905540|B1|Baseline|AQ-SS-AQ2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
79725|NCT01905540|P4|Participant Flow|SS-AQ-SS2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
79726|NCT01905540|P3|Participant Flow|SS-AQ-AQ2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
79727|NCT01905540|P2|Participant Flow|AQ-SS-SS2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
79728|NCT01905540|P1|Participant Flow|AQ-SS-AQ2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
79729|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
79734|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
79735|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
79736|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
79737|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
79738|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
79739|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
79740|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
79741|NCT01905540|E4|Reported Event|SSP-004184SS (2 Doses)|SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered in the morning and 21.8mg/kg administered 12 hours later.
79742|NCT01905540|E3|Reported Event|SSP-004184AQ (2 Doses)|SP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered in the morning and 40mg/kg administered 12 hours later.
79743|NCT01905540|E2|Reported Event|SSP-004184SS (Single Dose)|SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.
79744|NCT01905540|E1|Reported Event|SSP-004184AQ (Single Dose)|SSP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.
79745|NCT01905254|B1|Baseline|Single Arm Study|Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis.
79746|NCT01905254|P1|Participant Flow|Transient Elastography and Liver Biopsy|"Transient elastography was performed by two experienced investigators using a FibroScan (EchoSens, Paris, France), the median value of liver stiffness measurements was recorded in kilopascals (kPa).
Liver biopsy was carried out within 3 months of TE. Liver biopsies from the right and left lobe were obtained under laparoscopic control using the Tru-cut 16 GAUGE needle (Bard monopty; Bard biopsy systems, Tempe, USA).
Data analysis was performed on the remaining 34 patients (female: 28 (82%); male: 6 (18 %).
Indications for liver biopsy and Transient elastography were: 19 patients for follow-up of AIH while receiving immunosuppression and 15 patients for staging and grading of AIH before starting with an immunosuppressive therapy in."
79747|NCT01905254|O1|Outcome|Transient Elastography in Autoimmune Hepatitis|Liver stiffness (kPa) was correlated to histologic staging of liver cirrhosis
79748|NCT01905254|E1|Reported Event|TE in Autoimmune Hepatitis|"Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis.
There were no adverse events."
79749|NCT01904773|B1|Baseline|Overall Study|Part 1 & Part 2
79750|NCT01904773|P9|Participant Flow|Part 2- Seqence CBABCA|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
79751|NCT01904773|P8|Participant Flow|Part 2 Sequence CABBAC|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
79752|NCT01904773|P7|Participant Flow|Part 2- Sequence BCACBA|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
79753|NCT01904773|P6|Participant Flow|Part 2- Sequence BACCAB|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
79754|NCT01904773|P5|Participant Flow|Part 2- Sequence ACBABC|A= Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
79755|NCT01904773|P4|Participant Flow|Part 2 - Sequence ABCACB|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
79756|NCT01904773|P3|Participant Flow|Part 2- Sequence BABBAB|B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
79757|NCT01904773|P2|Participant Flow|Part 2 -Sequence BBABBA|B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
79758|NCT01904773|P1|Participant Flow|Initial Study|Initial Screen, Part 1: AZD5213 0.5 mg single dose Day 1, AZD5213 2 mg dose Days 6-8
79759|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
79760|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
79761|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
79762|NCT01904773|O3|Outcome|Placebo|Part 2 - multiple 3 week treatment periods in a randomized 6- period crossover design
79763|NCT01904773|O2|Outcome|AZD5213 2.0 mg|Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
79764|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
79765|NCT01904773|E7|Reported Event|Part 1 - Placebo|Part 1 - Placebo, Days 2-5, washout after 0.5 mg single dose
79766|NCT01904773|E6|Reported Event|Part 2 - Placebo|Part 2 - Placebo periods (2 periods)
79767|NCT01904773|E5|Reported Event|Part 2 - AZD5213 2.0 mg|Part 2 - AZD5213, 2.0 mg periods (2 periods)
79768|NCT01904773|E4|Reported Event|Part 2 - AZD5213 0.5 mg|Part 2 - AZD5213, 0.5 mg periods (2-4 periods)
79769|NCT01904773|E3|Reported Event|Part 1 - AZD5213 2.0 mg|Part 1 - Days 6-8, AZD5213 2.0 mg
79770|NCT01904773|E2|Reported Event|Part 1 - AZD5213 0.5 mg|Part 1 - Day 1, AZD5213 0.5 mg
79771|NCT01904773|E1|Reported Event|Overall Study|Part 1 & Part 2
79772|NCT01904760|B3|Baseline|Total|Total of all reporting groups
79773|NCT01904760|B2|Baseline|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
79774|NCT01904760|B1|Baseline|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
79775|NCT01904760|P2|Participant Flow|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
79776|NCT01904760|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
79777|NCT01904760|O2|Outcome|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
79778|NCT01904760|O1|Outcome|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
79779|NCT01904760|O2|Outcome|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
79780|NCT01904760|O1|Outcome|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
79781|NCT01904760|E2|Reported Event|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
79782|NCT01904760|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
79783|NCT01904721|B8|Baseline|Total|Total of all reporting groups
79784|NCT01904721|B7|Baseline|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79785|NCT01904721|B6|Baseline|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79786|NCT01904721|B5|Baseline|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79787|NCT01904721|B4|Baseline|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
79788|NCT01904721|B3|Baseline|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
79789|NCT01904721|B2|Baseline|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
79790|NCT01904721|B1|Baseline|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
79791|NCT01904721|P7|Participant Flow|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79792|NCT01904721|P6|Participant Flow|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79793|NCT01904721|P5|Participant Flow|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79794|NCT01904721|P4|Participant Flow|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
79795|NCT01904721|P3|Participant Flow|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
79796|NCT01904721|P2|Participant Flow|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
79797|NCT01904721|P1|Participant Flow|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
79798|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79799|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79800|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79801|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79802|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79803|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79804|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79805|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79806|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79807|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79808|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79809|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79810|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79811|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79812|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79813|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79814|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79815|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79816|NCT01904721|E7|Reported Event|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79817|NCT01904721|E6|Reported Event|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79818|NCT01904721|E5|Reported Event|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
79819|NCT01904721|E4|Reported Event|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
79820|NCT01904721|E3|Reported Event|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
79821|NCT01904721|E2|Reported Event|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
79822|NCT01904721|E1|Reported Event|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
79823|NCT01904604|B4|Baseline|Total|Total of all reporting groups
79824|NCT01904604|B3|Baseline|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).
High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79880|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
79881|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
79882|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
79825|NCT01904604|B2|Baseline|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79826|NCT01904604|B1|Baseline|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
79827|NCT01904604|P3|Participant Flow|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).
High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79848|NCT01904279|P1|Participant Flow|TCZ SC 162 mg Q3W|Participants with body weight less than (<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks.
79849|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
79850|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
79828|NCT01904604|P2|Participant Flow|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79829|NCT01904604|P1|Participant Flow|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
79830|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).
High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79831|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79832|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
79833|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).
High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79834|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79835|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
79836|NCT01904604|O2|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).
High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79837|NCT01904604|O1|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79838|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).
High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79839|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79840|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
79841|NCT01904604|E3|Reported Event|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).
High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79883|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
79884|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
79885|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
79886|NCT01904149|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours); Drug: Placebo single oral dose (first 8 hours) Arm type: placebo comparator; placebo single oral dose (first 8 hours)
79842|NCT01904604|E2|Reported Event|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
79843|NCT01904604|E1|Reported Event|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
79844|NCT01904279|B3|Baseline|Total|Total of all reporting groups
79845|NCT01904279|B2|Baseline|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
79846|NCT01904279|B1|Baseline|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
79847|NCT01904279|P2|Participant Flow|TCZ SC 162 mg Q2W|Participants with body weight greater than or equal to (>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.
79851|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 Weeks.
79852|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
79853|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
79854|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
79855|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
79856|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
79857|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
79858|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
79859|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
79860|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
79861|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
79862|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
79863|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
79864|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
79865|NCT01904279|E2|Reported Event|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
79866|NCT01904279|E1|Reported Event|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
79867|NCT01904149|B7|Baseline|Total|Total of all reporting groups
79868|NCT01904149|B6|Baseline|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
79869|NCT01904149|B5|Baseline|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
79870|NCT01904149|B4|Baseline|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
79871|NCT01904149|B3|Baseline|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
79872|NCT01904149|B2|Baseline|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
79873|NCT01904149|B1|Baseline|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
79874|NCT01904149|P6|Participant Flow|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
79875|NCT01904149|P5|Participant Flow|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
79876|NCT01904149|P4|Participant Flow|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
79877|NCT01904149|P3|Participant Flow|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
79878|NCT01904149|P2|Participant Flow|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
79879|NCT01904149|P1|Participant Flow|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
79887|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
79888|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
79889|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
79890|NCT01904149|O4|Outcome|PLACEBO|Drug: Placebo single oral dose (first 8 hours) Arm type: Placebo comparator; Placebo single oral dose (first 8 hours)
79891|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
79892|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
79893|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
79894|NCT01904149|E6|Reported Event|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
79895|NCT01904149|E5|Reported Event|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
79896|NCT01904149|E4|Reported Event|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
79897|NCT01904149|E3|Reported Event|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
79898|NCT01904149|E2|Reported Event|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
79899|NCT01904149|E1|Reported Event|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
79900|NCT01904071|B4|Baseline|Total|Total of all reporting groups
79901|NCT01904071|B3|Baseline|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg
IVMS (IV Morphine)"
79992|NCT01903876|P1|Participant Flow|General Health Promotion|A 3-hour general mental health web-based program.
80042|NCT01903460|P4|Participant Flow|Placebo Cohort B|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
79902|NCT01904071|B2|Baseline|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.
UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
79903|NCT01904071|B1|Baseline|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.
UFNB (Ultrasound guided femoral nerve block)"
79904|NCT01904071|P3|Participant Flow|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg
IVMS (IV Morphine)"
79905|NCT01904071|P2|Participant Flow|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.
UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
79906|NCT01904071|P1|Participant Flow|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.
UFNB (Ultrasound guided femoral nerve block)"
79907|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg
IVMS (IV Morphine)"
79908|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.
UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
79909|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.
UFNB (Ultrasound guided femoral nerve block)"
79910|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg
IVMS (IV Morphine)"
79911|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.
UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
79912|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.
UFNB (Ultrasound guided femoral nerve block)"
79913|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg
IVMS (IV Morphine)"
79914|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.
UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
79915|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.
UFNB (Ultrasound guided femoral nerve block)"
79916|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg
IVMS (IV Morphine)"
79917|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.
UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
79918|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.
UFNB (Ultrasound guided femoral nerve block)"
79919|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg
IVMS (IV Morphine)"
79920|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.
UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
79921|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.
UFNB (Ultrasound guided femoral nerve block)"
79922|NCT01904071|E3|Reported Event|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg
IVMS (IV Morphine)"
79923|NCT01904071|E2|Reported Event|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.
UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
79924|NCT01904071|E1|Reported Event|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.
UFNB (Ultrasound guided femoral nerve block)"
79925|NCT01904058|B5|Baseline|Total|Total of all reporting groups
79926|NCT01904058|B4|Baseline|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79927|NCT01904058|B3|Baseline|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79928|NCT01904058|B2|Baseline|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79929|NCT01904058|B1|Baseline|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79930|NCT01904058|P4|Participant Flow|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79931|NCT01904058|P3|Participant Flow|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79932|NCT01904058|P2|Participant Flow|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79933|NCT01904058|P1|Participant Flow|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79934|NCT01904058|O4|Outcome|Placebo + UDCA|Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.
79935|NCT01904058|O3|Outcome|LUM001 20 mg + UDCA|Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.
79936|NCT01904058|O2|Outcome|LUM001 10 mg + UDCA|Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
79937|NCT01904058|O1|Outcome|LUM001 5 mg + UDCA|Participants received LUM001 5 milligram (mg) tablet orally once daily for a period of 13 weeks in combination with UDCA.
79938|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79939|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79940|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79941|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79942|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79943|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79944|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
82264|NCT01890148|E1|Reported Event|AZD5069|AZD5069 45mg oral twice daily (BID)
79945|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79946|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79947|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79948|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79949|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79950|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79951|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79952|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79953|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79954|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79955|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79956|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79957|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79958|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79959|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79960|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79961|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79962|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79963|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79964|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
82265|NCT01890122|B5|Baseline|Total|Total of all reporting groups
79965|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
79966|NCT01904058|E4|Reported Event|Placebo + UDCA|Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.
79967|NCT01904058|E3|Reported Event|LUM001 20 mg + UDCA|Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.
79968|NCT01904058|E2|Reported Event|LUM001 10 mg + UDCA|Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
79969|NCT01904058|E1|Reported Event|LUM001 5 mg + UDCA|Participants received LUM001 5 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
79970|NCT01903993|B3|Baseline|Total|Total of all reporting groups
79971|NCT01903993|B2|Baseline|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
79972|NCT01903993|B1|Baseline|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
79973|NCT01903993|P2|Participant Flow|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
79974|NCT01903993|P1|Participant Flow|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
79975|NCT01903993|O1|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
79976|NCT01903993|O1|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
79977|NCT01903993|O1|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
79978|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
79979|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
79980|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
79981|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
79982|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
79983|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
79984|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
79985|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
79986|NCT01903993|E2|Reported Event|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
79987|NCT01903993|E1|Reported Event|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
79988|NCT01903876|B3|Baseline|Total|Total of all reporting groups
79989|NCT01903876|B2|Baseline|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.
Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
79990|NCT01903876|B1|Baseline|General Health Promotion|"A 3-hour general mental health web-based program.
General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
79991|NCT01903876|P2|Participant Flow|Bystander & Sexual Violence Prevention|A 3-hour web-based program designed to teach male college student bystanders to intervene.
79993|NCT01903876|O2|Outcome|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.
Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
79994|NCT01903876|O1|Outcome|General Health Promotion|"A 3-hour general mental health web-based program.
General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
79995|NCT01903876|O2|Outcome|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.
Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
79996|NCT01903876|O1|Outcome|General Health Promotion|"A 3-hour general mental health web-based program.
General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
79997|NCT01903876|E2|Reported Event|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.
Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
79998|NCT01903876|E1|Reported Event|General Health Promotion|"A 3-hour general mental health web-based program.
General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
79999|NCT01903863|B3|Baseline|Total|Total of all reporting groups
80000|NCT01903863|B2|Baseline|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80001|NCT01903863|B1|Baseline|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80029|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80002|NCT01903863|P2|Participant Flow|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80003|NCT01903863|P1|Participant Flow|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
80004|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80005|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
80006|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80007|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
80008|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80009|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
80010|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80011|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
80012|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80030|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80013|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
80014|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80015|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
80016|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80017|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
80018|NCT01903863|O2|Outcome|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80019|NCT01903863|O1|Outcome|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
80020|NCT01903863|E2|Reported Event|Control|"Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period."
80021|NCT01903863|E1|Reported Event|Scheduled Fresh Frozen Plasma|"Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement."
80022|NCT01903720|B1|Baseline|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80023|NCT01903720|P1|Participant Flow|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80024|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80025|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80026|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80027|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80028|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80061|NCT01903265|B3|Baseline|Total|Total of all reporting groups
80031|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80032|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80033|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80034|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80035|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80036|NCT01903720|E1|Reported Event|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
80037|NCT01903460|B5|Baseline|Total|Total of all reporting groups
80038|NCT01903460|B4|Baseline|Placebo Cohort B|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
80039|NCT01903460|B3|Baseline|Placebo Cohort A|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
80040|NCT01903460|B2|Baseline|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
80041|NCT01903460|B1|Baseline|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
80110|NCT01903148|E1|Reported Event|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
80043|NCT01903460|P3|Participant Flow|Placebo Cohort A|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
80044|NCT01903460|P2|Participant Flow|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
80045|NCT01903460|P1|Participant Flow|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
80046|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
80047|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
80048|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
80049|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
80050|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
80051|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
80052|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
80053|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
80054|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
80055|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
80056|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
80057|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
80058|NCT01903460|E3|Reported Event|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
80059|NCT01903460|E2|Reported Event|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
80060|NCT01903460|E1|Reported Event|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
80062|NCT01903265|B2|Baseline|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. (One patient randomized in error never received study drug and therefore is not included in this table.)"
80063|NCT01903265|B1|Baseline|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80064|NCT01903265|P2|Participant Flow|Placebo|1 tablet of placebo sublingually each day at bedtime for 12 weeks.
80065|NCT01903265|P1|Participant Flow|TNX-102 SL 2.8 mg|1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks
80066|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80067|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80068|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80069|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80070|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80071|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80111|NCT01903005|B3|Baseline|Total|Total of all reporting groups
80072|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80073|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80074|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80075|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80076|NCT01903265|E2|Reported Event|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80077|NCT01903265|E1|Reported Event|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
80078|NCT01903187|B3|Baseline|Total|Total of all reporting groups
80079|NCT01903187|B2|Baseline|Sham Procedure|"Sham procedure
Sham: Renal artery angiogram"
80080|NCT01903187|B1|Baseline|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
80081|NCT01903187|P2|Participant Flow|Sham Procedure|"Sham procedure
Sham: Renal artery angiogram"
80082|NCT01903187|P1|Participant Flow|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
80083|NCT01903187|O2|Outcome|Sham|Renal artery angiogram without renal denervation
80084|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
80085|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
80086|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
80087|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
80088|NCT01903187|O2|Outcome|Sham Procedure|"Sham procedure
Sham: Renal artery angiogram"
80089|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
80090|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
80091|NCT01903187|E2|Reported Event|Sham Procedure|"Sham procedure
Sham: Renal artery angiogram
Subjects exited after 1 month follow up"
80092|NCT01903187|E1|Reported Event|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
80093|NCT01903148|B3|Baseline|Total|Total of all reporting groups
80094|NCT01903148|B2|Baseline|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
80095|NCT01903148|B1|Baseline|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
80096|NCT01903148|P1|Participant Flow|Patients With Anemia and CKD|Adults patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.
80097|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
80098|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
80099|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
80100|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
80101|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
80102|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
80103|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
80104|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
80105|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
80106|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
80107|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
80108|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
80109|NCT01903148|E2|Reported Event|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
80112|NCT01903005|B2|Baseline|OX219-007 Completers|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80113|NCT01903005|B1|Baseline|OX219-006 Completers|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80114|NCT01903005|P1|Participant Flow|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80115|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80116|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80117|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80118|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80119|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80120|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80121|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80122|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80123|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80124|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80125|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80126|NCT01903005|E1|Reported Event|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
80127|NCT01902888|B1|Baseline|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
GORE® VIABAHN® Endoprosthesis"
80128|NCT01902888|P1|Participant Flow|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
GORE® VIABAHN® Endoprosthesis"
80129|NCT01902888|O1|Outcome|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
GORE® VIABAHN® Endoprosthesis"
80130|NCT01902888|O1|Outcome|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
GORE® VIABAHN® Endoprosthesis"
80131|NCT01902888|E1|Reported Event|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
GORE® VIABAHN® Endoprosthesis"
80132|NCT01902758|B3|Baseline|Total|Total of all reporting groups
80133|NCT01902758|B2|Baseline|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group
placebo: placebo for comparison group"
80134|NCT01902758|B1|Baseline|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
ambrisentan and theophylline"
80135|NCT01902758|P2|Participant Flow|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group
placebo: placebo for comparison group"
80136|NCT01902758|P1|Participant Flow|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
ambrisentan and theophylline"
80137|NCT01902758|O2|Outcome|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group
placebo: placebo for comparison group"
80138|NCT01902758|O1|Outcome|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
ambrisentan and theophylline"
80139|NCT01902758|E2|Reported Event|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group
placebo: placebo for comparison group"
80140|NCT01902758|E1|Reported Event|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
ambrisentan and theophylline"
80141|NCT01902303|B3|Baseline|Total|Total of all reporting groups
80142|NCT01902303|B2|Baseline|BTL-TML-HSV Active Treatment|BTL-TML Safety Population - All subjects enrolled and received active test article
80143|NCT01902303|B1|Baseline|Matching Placebo|Placebo Safety Population - All subjects enrolled and received placebo test article
80184|NCT01902134|E1|Reported Event|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses.
80144|NCT01902303|P2|Participant Flow|BTL-TML-HSV|"Experimental Product
BTL-TML-HSV: Sublingual micro dosing of BTL-TML-HSV for 7 days
Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):
Day 0 – Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.
Days 1 & 2 – Take 1 drop six times daily –
Days 3-7 – Take one drop twice daily"
80145|NCT01902303|P1|Participant Flow|Matching Placebo|"Matching Placebo
Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):
Day 0 – Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.
Days 1 & 2 – Take 1 drop six times daily –
Days 3-7 – Take one drop twice daily"
80146|NCT01902303|O2|Outcome|BTL-TML-HSV Active Treatment|BTL-TML Efficacy Population - All subjects who received active test article and were compliant with protocol
80147|NCT01902303|O1|Outcome|Matching Placebo|Placebo efficacy Population - All subjects who received placebo test article and were compliant with protocol
80148|NCT01902303|O2|Outcome|BTL-TML-HSV Active Treatment|BTL-TML Efficacy Population - All subjects enrolled and received active test article and met Per Protocol definition
80149|NCT01902303|O1|Outcome|Matching Placebo|Placebo Efficacy Population - All subjects enrolled and received placebo test article and met Per protocol definition
80150|NCT01902303|E2|Reported Event|BTL-TML-HSV Active Treatment|BTL-TML Safety Population - All subjects enrolled and allocated to active test article except for SAEs which includes all subjects that signed informed consent.
80151|NCT01902303|E1|Reported Event|Matching Placebo|Placebo Safety Population - All subjects that enrolled and were allocated to placebo test article except for SAEs and that includes all subjects that signed informed consent.
80152|NCT01902134|B7|Baseline|Total|Total of all reporting groups
80153|NCT01902134|B6|Baseline|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
80154|NCT01902134|B5|Baseline|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
80155|NCT01902134|B4|Baseline|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
80156|NCT01902134|B3|Baseline|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
80157|NCT01902134|B2|Baseline|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
80158|NCT01902134|B1|Baseline|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
80159|NCT01902134|P6|Participant Flow|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
80160|NCT01902134|P5|Participant Flow|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses Placebo followed by DKP
80161|NCT01902134|P4|Participant Flow|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
80162|NCT01902134|P3|Participant Flow|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
80163|NCT01902134|P2|Participant Flow|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
80164|NCT01902134|P1|Participant Flow|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
80165|NCT01902134|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours);
80166|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
80167|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
80168|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
80222|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen
IV ibuprofen"
80169|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
80170|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 5 days (a total of 12 doses)
80171|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
80172|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
80173|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 5 days (a total of 12 doses)
80174|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
80175|NCT01902134|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose (first 8 hours);
80176|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
80177|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
80178|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
80179|NCT01902134|E6|Reported Event|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses.
80180|NCT01902134|E5|Reported Event|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses.
80181|NCT01902134|E4|Reported Event|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses.
80182|NCT01902134|E3|Reported Event|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses.
80183|NCT01902134|E2|Reported Event|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses.
80185|NCT01901588|B3|Baseline|Total|Total of all reporting groups
80186|NCT01901588|B2|Baseline|Placebo|"patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo"
80187|NCT01901588|B1|Baseline|Dexmedetomidine|"dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
80188|NCT01901588|P2|Participant Flow|Placebo|"patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo"
80189|NCT01901588|P1|Participant Flow|Dexmedetomidine|"dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
80190|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo"
80191|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
80192|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo"
80193|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
80194|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo"
80195|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
80196|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo"
80197|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
80198|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo"
80199|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
80200|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo"
80201|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
80202|NCT01901588|E2|Reported Event|Placebo|"patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo"
80203|NCT01901588|E1|Reported Event|Dexmedetomidine|"dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
80204|NCT01901575|B1|Baseline|Remifentanil|Remifentanil IV PCA
80205|NCT01901575|P1|Participant Flow|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
80206|NCT01901575|O1|Outcome|Remifentanil IV PCA|"patients with PVC's prior to administration of remifentanil
Remifentanil: Patients with established PVC's , sedated with remifentanil IVPCA per study protocol"
80207|NCT01901575|E1|Reported Event|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
80208|NCT01901393|B3|Baseline|Total|Total of all reporting groups
80209|NCT01901393|B2|Baseline|Ketorolac|"30mg ketorolac
Ketorolac"
80210|NCT01901393|B1|Baseline|IV Ibuprofen|"800mg ibuprofen
IV ibuprofen"
80211|NCT01901393|P2|Participant Flow|Ketorolac|"30mg ketorolac
Ketorolac"
80212|NCT01901393|P1|Participant Flow|IV Ibuprofen|"800mg ibuprofen
IV ibuprofen"
80213|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac
Ketorolac"
80214|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen
IV ibuprofen"
80215|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac
Ketorolac"
80216|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen
IV ibuprofen"
80217|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac
Ketorolac"
80218|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen
IV ibuprofen"
80219|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac
Ketorolac"
80220|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen
IV ibuprofen"
80221|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac
Ketorolac"
80226|NCT01901393|E1|Reported Event|IV Ibuprofen|"800mg ibuprofen
IV ibuprofen"
80227|NCT01901341|B3|Baseline|Total|Total of all reporting groups
80228|NCT01901341|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
80229|NCT01901341|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80230|NCT01901341|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
80231|NCT01901341|P1|Participant Flow|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80232|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
80233|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80234|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
80235|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80236|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
80237|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80238|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a12-week treatment period
80239|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80240|NCT01901341|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
80241|NCT01901341|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80242|NCT01901328|B3|Baseline|Total|Total of all reporting groups
80243|NCT01901328|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
80244|NCT01901328|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80245|NCT01901328|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
80246|NCT01901328|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945 administered orally twice dailly (BID) for a 12-week treatment period
80247|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
82667|NCT01886781|P1|Participant Flow|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
80248|NCT01901328|O1|Outcome|CB-5945|0.25 milligrams CB-5945 administered orally BID for a 12-week treatment period
80249|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
80250|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80251|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
80252|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80253|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
80254|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80255|NCT01901328|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
80256|NCT01901328|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80257|NCT01901302|B3|Baseline|Total|Total of all reporting groups
80258|NCT01901302|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
80259|NCT01901302|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80260|NCT01901302|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
80261|NCT01901302|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945 administered orally twice daily (BID) for a 12-week treatment period
80262|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
80263|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80264|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
80265|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80266|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
80267|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80268|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
80269|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80270|NCT01901302|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
80271|NCT01901302|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
80272|NCT01901250|B3|Baseline|Total|Total of all reporting groups
80273|NCT01901250|B2|Baseline|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.
Oral health education: Oral health education, toothbrush, and fluoride toothpaste
Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
80274|NCT01901250|B1|Baseline|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.
Oral health education: Oral health education, toothbrush, and fluoride toothpaste
Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
80357|NCT01900067|E1|Reported Event|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
80358|NCT01900054|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 12 weeks
80275|NCT01901250|P2|Participant Flow|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.
Oral health education: Oral health education, toothbrush, and fluoride toothpaste
Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
80276|NCT01901250|P1|Participant Flow|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.
Oral health education: Oral health education, toothbrush, and fluoride toothpaste
Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
80277|NCT01901250|O2|Outcome|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.
Oral health education: Oral health education, toothbrush, and fluoride toothpaste
Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
80307|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80533|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80278|NCT01901250|O1|Outcome|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.
Oral health education: Oral health education, toothbrush, and fluoride toothpaste
Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
80279|NCT01901250|E2|Reported Event|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.
Oral health education: Oral health education, toothbrush, and fluoride toothpaste
Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
80280|NCT01901250|E1|Reported Event|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.
Oral health education: Oral health education, toothbrush, and fluoride toothpaste
Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
80281|NCT01901211|B3|Baseline|Total|Total of all reporting groups
80282|NCT01901211|B2|Baseline|Comparison Arm|"In this arm of the study, participants will complete comparison activities during the first ten-week then after 6-week washout, will participate in the exergaming intervention during the second ten-week period.
Participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
80283|NCT01901211|B1|Baseline|Exergaming|"In this arm, the participants will participate in the exergaming intervention during the first ten-week then after 6-week washout, will participate in the comparison activities during the second ten-week period.
Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
80284|NCT01901211|P2|Participant Flow|Comparison Arm|"In this arm of the study, participants will participate in comparison activities during the first ten-week period then after 6-week washout, will participate in the Exergaming activities during the second ten-week period.
participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
80285|NCT01901211|P1|Participant Flow|Exergaming|"In this arm, the participants will participate in the exergaming intervention during the first ten-week period then after 6-week washout, will participate in the comparison during the second ten-week period.
Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
80359|NCT01900054|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 12 weeks
80286|NCT01901211|O2|Outcome|Comparison Arm|In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week.
80287|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention.
Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
80288|NCT01901211|E2|Reported Event|Comparison Arm|"In this arm of the study, participants will participate in comparison activities during the first ten-week period then after 6-week washout, will participate in the Exergaming activities during the second ten-week period.
participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
80308|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
82668|NCT01886781|O2|Outcome|Placebo|Controls Crytalline cellulose powder
80289|NCT01901211|E1|Reported Event|Exergaming|"In this arm, the participants will participate in the exergaming intervention during the first ten-week period then after 6-week washout, will participate in the comparison during the second ten-week period.
Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
80290|NCT01901185|B1|Baseline|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
80291|NCT01901185|P1|Participant Flow|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
80292|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
80293|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
80294|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
80295|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
80296|NCT01901185|E1|Reported Event|Autoinjector A/Etanercept|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week at Weeks 1 - 5 (total of 6 injections).
80297|NCT01900431|B3|Baseline|Total|Total of all reporting groups
80298|NCT01900431|B2|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C).
80299|NCT01900431|B1|Baseline|Placebo|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C).
80300|NCT01900431|P3|Participant Flow|Sarilumab 200 mg q2w (Open-Label Treatment)|Non-responders and non-completers observed in Part A were treated with Sarilumab 200 mg SC injection q2w for 34 weeks as open-label treatment in open-label treatment period (Part C) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80301|NCT01900431|P2|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
80302|NCT01900431|P1|Participant Flow|Placebo|Placebo (for Sarilumab) subcutaneous (SC) injection every 2 weeks (q2w) for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with Methotrexate (MTX) 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
80360|NCT01900054|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 12 weeks
80361|NCT01900054|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 12 weeks
80362|NCT01900054|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 12 weeks
80363|NCT01899911|B1|Baseline|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest
VSP: Infrared and red absorbance measurement"
80303|NCT01900431|O1|Outcome|Sarilumab 200 mg q2w (Part A + Part B)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
80304|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80305|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80306|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80439|NCT01899742|B3|Baseline|Total|Total of all reporting groups
80309|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80310|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80311|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80312|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80313|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80314|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80315|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80316|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80317|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80318|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80319|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80320|NCT01900431|O2|Outcome|Sarilumab 200 mg q2w (Part A)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80321|NCT01900431|O1|Outcome|Placebo (Part A)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80322|NCT01900431|E3|Reported Event|Sarilumab 200 mg q2w: Open-Label Treatment (Part C)|Non-responders and non-completers observed in Part A were proposed to be treated with Sarilumab 200 mg SC injection q2w for 34 weeks as open-label treatment in open-label treatment period (Part-C) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
80323|NCT01900431|E2|Reported Event|Sarilumab 200 mg q2w (Part A+ Part B)|Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
80324|NCT01900431|E1|Reported Event|Placebo (Part A + Part B)|Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
80325|NCT01900314|B3|Baseline|Total|Total of all reporting groups
80326|NCT01900314|B2|Baseline|Sham rTMS|20 sham sessions
80327|NCT01900314|B1|Baseline|Active rTMS|20 active sessions
80328|NCT01900314|P2|Participant Flow|Sham rTMS|"20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second functional magnetic resonance imaging scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.
repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
80440|NCT01899742|B2|Baseline|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
82669|NCT01886781|O1|Outcome|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
80329|NCT01900314|P1|Participant Flow|Active rTMS|"20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second functional magnetic resonance imaging scan will be completed then 5 additional tapering treatments of rTMS over a 2 week period.
repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
80330|NCT01900314|O2|Outcome|Sham rTMS|20 sham sessions
80331|NCT01900314|O1|Outcome|Active rTMS|20 active sessions
80332|NCT01900314|O2|Outcome|Sham rTMS|20 sham sessions
80333|NCT01900314|O1|Outcome|Active rTMS|20 active sessions of rTMS
80334|NCT01900314|E2|Reported Event|Sham rTMS|"20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.
repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
80335|NCT01900314|E1|Reported Event|Active rTMS|"20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period.
repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
80336|NCT01900249|B4|Baseline|Total|Total of all reporting groups
80337|NCT01900249|B3|Baseline|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
80338|NCT01900249|B2|Baseline|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
80339|NCT01900249|B1|Baseline|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
80340|NCT01900249|P3|Participant Flow|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
80341|NCT01900249|P2|Participant Flow|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
80342|NCT01900249|P1|Participant Flow|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
80343|NCT01900249|O3|Outcome|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
80344|NCT01900249|O2|Outcome|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
80345|NCT01900249|O1|Outcome|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
80346|NCT01900249|E3|Reported Event|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
80347|NCT01900249|E2|Reported Event|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
80348|NCT01900249|E1|Reported Event|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
80349|NCT01900067|B3|Baseline|Total|Total of all reporting groups
80350|NCT01900067|B2|Baseline|Control|no active warming, standard of care
80351|NCT01900067|B1|Baseline|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
80352|NCT01900067|P2|Participant Flow|Control|no active warming, standard of care
80353|NCT01900067|P1|Participant Flow|Active Warming|"BARRIER® EasyWarm Active Self-Warming Blanket
BARRIER® EasyWarm Active Self-Warming Blanket"
80354|NCT01900067|O2|Outcome|Control|No active warming, standard of care
80355|NCT01900067|O1|Outcome|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
80356|NCT01900067|E2|Reported Event|Control|No active warming, standard of care
80364|NCT01899911|P1|Participant Flow|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest
VSP: Infrared and red absorbance measurement"
80365|NCT01899911|O1|Outcome|Vital Signs Patch (VSP)|Infrared and Red absorbance measurement on chest
80366|NCT01899911|E1|Reported Event|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest
VSP: Infrared and red absorbance measurement"
80367|NCT01899768|B1|Baseline|GSK2339345 1000 µg/Placebo|Participants received two doses of either GSK2339345 1000 µg or matching placebo as a solution administered via an ADI with a four hour dosing interval at 3 visits (one treatment per visit) in Part A and a single dose at 2 visits (one treatment per visit) in Part B and C. Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo or GSK2339345 at each visit period in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit of Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80441|NCT01899742|B1|Baseline|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
80368|NCT01899768|P1|Participant Flow|GSK2339345 1000 µg|Participants received two doses of either GSK2339345 1000 µg or matching placebo as a solution administered via an ADI with a four hour dosing interval at 3 visits (one treatment per visit) in Part A and a single dose at 2 visits (one treatment per visit) in Part B and C. Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo or GSK2339345 at each visit period in Part B and C, participants received an oral inhalation of 10 microliter (µL) of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit of Part C. The strength of capsaicin solution ranged from 0.49 to 1000 micromolar (µM) and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80369|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80370|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80371|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80372|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80373|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80462|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80463|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80464|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80374|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80442|NCT01899742|P2|Participant Flow|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
80607|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80375|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80376|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80377|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80378|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80379|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80380|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80381|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80465|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80680|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
80382|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80383|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80384|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80385|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80386|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80387|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80388|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80389|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80466|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80681|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
80390|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80391|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80392|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80393|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80394|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80395|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80396|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80397|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80467|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80635|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80398|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80399|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80400|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80401|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80402|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80403|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80404|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80405|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80468|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80675|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
80406|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80407|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80408|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80409|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80410|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80411|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80412|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80413|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80469|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80676|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
80414|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80415|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80416|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80417|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80418|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80419|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80420|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80421|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80470|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80677|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
80422|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80423|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80424|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80425|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80426|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80427|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80428|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80429|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80471|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80678|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
80430|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80431|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80432|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80433|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80434|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80435|NCT01899768|O2|Outcome|GSK2339345 1000 Microgram (mcg)|Participants received two doses of GSK2339345 1000 mcg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80436|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80437|NCT01899768|E2|Reported Event|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80472|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80679|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
80438|NCT01899768|E1|Reported Event|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
80443|NCT01899742|P1|Participant Flow|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg) once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
80444|NCT01899742|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
80445|NCT01899742|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
80446|NCT01899742|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
80447|NCT01899742|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
80448|NCT01899742|E2|Reported Event|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
80449|NCT01899742|E1|Reported Event|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
80450|NCT01899677|B3|Baseline|Total|Total of all reporting groups
80451|NCT01899677|B2|Baseline|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80452|NCT01899677|B1|Baseline|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80453|NCT01899677|P2|Participant Flow|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80454|NCT01899677|P1|Participant Flow|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80455|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80456|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80457|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80458|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80459|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80460|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80461|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
81143|NCT01895452|P2|Participant Flow|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
80473|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80474|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80475|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80476|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80477|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80478|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80479|NCT01899677|E2|Reported Event|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
80480|NCT01899677|E1|Reported Event|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
80481|NCT01899144|B1|Baseline|All Participants|Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
80482|NCT01899144|P1|Participant Flow|All Participants|Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
80483|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
80484|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
80485|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
80486|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
80487|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
80488|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
80489|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
80490|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
80491|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
80492|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
80493|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
80494|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
80495|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
80525|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
81144|NCT01895452|P1|Participant Flow|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
80496|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
80497|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
80498|NCT01899144|E5|Reported Event|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
80499|NCT01899144|E4|Reported Event|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
80500|NCT01899144|E3|Reported Event|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
80608|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80501|NCT01899144|E2|Reported Event|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
80502|NCT01899144|E1|Reported Event|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.
In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
80503|NCT01898884|B6|Baseline|Total|Total of all reporting groups
80504|NCT01898884|B5|Baseline|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80505|NCT01898884|B4|Baseline|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80506|NCT01898884|B3|Baseline|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80507|NCT01898884|B2|Baseline|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80508|NCT01898884|B1|Baseline|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
80509|NCT01898884|P9|Participant Flow|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80510|NCT01898884|P8|Participant Flow|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80511|NCT01898884|P7|Participant Flow|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80512|NCT01898884|P6|Participant Flow|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80513|NCT01898884|P5|Participant Flow|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80514|NCT01898884|P4|Participant Flow|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80515|NCT01898884|P3|Participant Flow|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80516|NCT01898884|P2|Participant Flow|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80517|NCT01898884|P1|Participant Flow|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
80518|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80519|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80520|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80521|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80522|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80523|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80524|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80556|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80526|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80527|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80528|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80529|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80530|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80531|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80532|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
82670|NCT01886781|E2|Reported Event|Placebo|Controls Crytalline cellulose powder
80534|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80535|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80536|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80537|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80538|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80539|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80540|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80541|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80542|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80543|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80544|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80545|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80546|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80547|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80548|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80549|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80550|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80551|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80552|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80553|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80554|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80555|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80595|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80557|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80558|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80559|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80560|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80561|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80562|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80563|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80564|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80565|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80566|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80567|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80568|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80569|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80570|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80571|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80572|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80573|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80574|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80575|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80576|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80577|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80578|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80579|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80580|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80581|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80582|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80583|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80584|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80585|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80586|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80587|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80588|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80589|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80590|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80591|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80592|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80593|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80594|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80596|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80597|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80598|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80599|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80600|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80601|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
80602|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80603|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80604|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80605|NCT01898884|O2|Outcome|Single Dose VP 20629 150mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80606|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
80609|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80610|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80611|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80612|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80613|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80614|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80615|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
80616|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80617|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80618|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80619|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80620|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
80621|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80622|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80623|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80624|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80625|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80626|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80627|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80628|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80629|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
80630|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80631|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80632|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80633|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80634|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80636|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80637|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80638|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
80639|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80640|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80641|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80642|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80643|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80644|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80645|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80646|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80647|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
80648|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80649|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80650|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80651|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80652|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
80653|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
80654|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
80655|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
80656|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
80657|NCT01898884|E9|Reported Event|Multiple Dose VP 20629 900mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80658|NCT01898884|E8|Reported Event|Multiple Dose VP 20629 600mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80659|NCT01898884|E7|Reported Event|Multiple Dose VP 20629 300mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
80660|NCT01898884|E6|Reported Event|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
80661|NCT01898884|E5|Reported Event|Single Dose VP 20629 1200mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting conditions on Day 1.
80662|NCT01898884|E4|Reported Event|Single Dose VP 20629 900mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting conditions on Day 1.
80663|NCT01898884|E3|Reported Event|Single Dose VP 20629 450mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting conditions on Day 1.
80664|NCT01898884|E2|Reported Event|Single Dose VP 20629 150mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting conditions on Day 1.
80665|NCT01898884|E1|Reported Event|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting conditions on Day 1.
80666|NCT01898598|B3|Baseline|Total|Total of all reporting groups
80667|NCT01898598|B2|Baseline|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
80668|NCT01898598|B1|Baseline|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
80669|NCT01898598|P2|Participant Flow|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
80670|NCT01898598|P1|Participant Flow|Vismodegib|Participants received vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
80671|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
80672|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
80673|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
80674|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
81145|NCT01895452|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
80682|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
80683|NCT01898598|E2|Reported Event|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
80684|NCT01898598|E1|Reported Event|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
80685|NCT01898442|B4|Baseline|Total|Total of all reporting groups
80686|NCT01898442|B3|Baseline|Ticagrelor 360mg|"High ticagrelor 360mg loading dose
Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
80687|NCT01898442|B2|Baseline|Ticagrelor 270mg|"High ticagrelor 270mg loading dose
Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
80688|NCT01898442|B1|Baseline|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose
Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
80689|NCT01898442|P3|Participant Flow|Ticagrelor 360mg|"High ticagrelor 360mg loading dose
Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
80690|NCT01898442|P2|Participant Flow|Ticagrelor 270mg|"High ticagrelor 270mg loading dose
Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
80691|NCT01898442|P1|Participant Flow|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose
Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
80692|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose
Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
80693|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose
Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
80694|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose
Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
80695|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose
Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
80696|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose
Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
80697|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose
Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
80698|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose
Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
80699|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose
Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
80700|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose
Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
80701|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose
Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
80702|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose
Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
80703|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose
Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
80704|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose
Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
80705|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose
Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
80706|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose
Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
80707|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose
Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
80708|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose
Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
80709|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose
Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
80710|NCT01898442|E3|Reported Event|Ticagrelor 360mg|"High ticagrelor 360mg loading dose
Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
80711|NCT01898442|E2|Reported Event|Ticagrelor 270mg|"High ticagrelor 270mg loading dose
Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
80712|NCT01898442|E1|Reported Event|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose
Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
80713|NCT01898403|B1|Baseline|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
Indocyanine green solution: Administered peri-tumoral and intradermally
Isosulfan blue (ISB): Administered peri-tumoral and intradermally
Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
80714|NCT01898403|P1|Participant Flow|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
Indocyanine green solution: Administered peri-tumoral and intradermally
Isosulfan blue (ISB): Administered peri-tumoral and intradermally
Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
80715|NCT01898403|O3|Outcome|Sentinel Lymph Node (SLN) Detection by TSC Lymphoscintigraphy|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
80716|NCT01898403|O2|Outcome|Sentinel Lymph Node (SLN) Detection by Indocyanine Green|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
80717|NCT01898403|O1|Outcome|Sentinel Lymph Node (SLN) Detection by Isosulfan Blue|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
80718|NCT01898403|E1|Reported Event|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
Indocyanine green solution: Administered peri-tumoral and intradermally
Isosulfan blue (ISB): Administered peri-tumoral and intradermally
Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
80719|NCT01898286|B1|Baseline|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
80720|NCT01898286|P1|Participant Flow|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
80721|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
80722|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
80723|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
80724|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
80725|NCT01898286|E1|Reported Event|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
80726|NCT01898208|B4|Baseline|Total|Total of all reporting groups
81057|NCT01896050|O1|Outcome|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
80727|NCT01898208|B3|Baseline|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80728|NCT01898208|B2|Baseline|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80729|NCT01898208|B1|Baseline|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80730|NCT01898208|P3|Participant Flow|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80731|NCT01898208|P2|Participant Flow|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture Infectious Disease (ID) Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80732|NCT01898208|P1|Participant Flow|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80733|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80734|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80735|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80736|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80737|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80738|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80739|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80740|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80741|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80742|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80743|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80744|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80745|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80746|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80747|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80748|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80749|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80750|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80751|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80752|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80753|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80754|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80755|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80756|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80757|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80758|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80759|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80760|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80761|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80762|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80763|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80764|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80765|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80766|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80767|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80768|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80769|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80770|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80854|NCT01897285|O1|Outcome|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive
AQUACEL® foam adhesive dressing"
80771|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80772|NCT01898208|E3|Reported Event|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
80773|NCT01898208|E2|Reported Event|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
80774|NCT01898208|E1|Reported Event|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
80775|NCT01898195|B4|Baseline|Total|Total of all reporting groups
80776|NCT01898195|B3|Baseline|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
80777|NCT01898195|B2|Baseline|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months"
80778|NCT01898195|B1|Baseline|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.
Varenicline: Varenicline will be provided for three months."
80864|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80779|NCT01898195|P3|Participant Flow|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
80780|NCT01898195|P2|Participant Flow|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months"
80781|NCT01898195|P1|Participant Flow|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.
Varenicline: Varenicline will be provided for three months."
80782|NCT01898195|O3|Outcome|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
80783|NCT01898195|O2|Outcome|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months"
80784|NCT01898195|O1|Outcome|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.
Varenicline: Varenicline will be provided for three months."
80785|NCT01898195|O3|Outcome|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
80786|NCT01898195|O2|Outcome|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months"
80787|NCT01898195|O1|Outcome|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.
Varenicline: Varenicline will be provided for three months."
80788|NCT01898195|E3|Reported Event|Standard Care + Text Message + ABT|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months
Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period"
80789|NCT01898195|E2|Reported Event|Standard Care + Text Message|"Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts.
Varenicline: Varenicline will be provided for three months.
Text Message: Text messages will be developed twice daily for three months"
80790|NCT01898195|E1|Reported Event|Standard Care|"Participants in this arm will receive varenicline for smoking cessation.
Varenicline: Varenicline will be provided for three months."
80791|NCT01898091|B3|Baseline|Total|Total of all reporting groups
80792|NCT01898091|B2|Baseline|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Placebo Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
80793|NCT01898091|B1|Baseline|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Neem Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
80794|NCT01898091|P2|Participant Flow|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Placebo Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base], three times per day, for approximately 7 weeks during radiation therapy."
80818|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80795|NCT01898091|P1|Participant Flow|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Neem Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base plus 1% solution by weight of neem supercritical extract], three times per day, for approximately 7 weeks during radiation therapy."
80796|NCT01898091|O2|Outcome|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Placebo Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
80797|NCT01898091|O1|Outcome|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Neem Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
80798|NCT01898091|E2|Reported Event|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Placebo Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base], three times per day, for approximately 7 weeks during radiation therapy."
80799|NCT01898091|E1|Reported Event|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Neem Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base plus 1% solution by weight of neem supercritical extract], three times per day, for approximately 7 weeks during radiation therapy."
80800|NCT01897792|B3|Baseline|Total|Total of all reporting groups
81058|NCT01896050|E2|Reported Event|Tamoxifen|Subjects who started treatment with tamoxifen
80801|NCT01897792|B2|Baseline|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C
Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
80802|NCT01897792|B1|Baseline|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Vitamin C
Vitamin E"
80803|NCT01897792|P2|Participant Flow|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C
Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
80804|NCT01897792|P1|Participant Flow|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Vitamin C
Vitamin E"
80805|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80806|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80807|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80808|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80809|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80810|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80811|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80812|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80813|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80814|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80815|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill Participants - Protocol Violations|# of protocol deviations
80816|NCT01897792|O1|Outcome|Vitamin C and E Participants -|# of protocol deviations
80817|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80853|NCT01897285|O2|Outcome|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive
AQUACEL® foam adhesive dressing"
80819|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80820|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80821|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80822|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
80823|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C
Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
80824|NCT01897792|O1|Outcome|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Vitamin C
Vitamin E"
80825|NCT01897792|E2|Reported Event|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C
Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
80826|NCT01897792|E1|Reported Event|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Vitamin C
Vitamin E"
80827|NCT01897727|B3|Baseline|Total|Total of all reporting groups
80828|NCT01897727|B2|Baseline|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
80829|NCT01897727|B1|Baseline|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
80830|NCT01897727|P2|Participant Flow|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
80831|NCT01897727|P1|Participant Flow|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
80832|NCT01897727|O2|Outcome|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
80833|NCT01897727|O1|Outcome|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
80834|NCT01897727|E2|Reported Event|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
80835|NCT01897727|E1|Reported Event|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
80836|NCT01897402|B3|Baseline|Total|Total of all reporting groups
80837|NCT01897402|B2|Baseline|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
80838|NCT01897402|B1|Baseline|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
80839|NCT01897402|P2|Participant Flow|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
80840|NCT01897402|P1|Participant Flow|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
80841|NCT01897402|O2|Outcome|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
80842|NCT01897402|O1|Outcome|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
80843|NCT01897402|O4|Outcome|US Licensed Vaccine - Female|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
80844|NCT01897402|O3|Outcome|US Licensed Vaccine - Male|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
80845|NCT01897402|O2|Outcome|Test Vaccine - Female|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
80846|NCT01897402|O1|Outcome|Test Vaccine - Male|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
80847|NCT01897402|O2|Outcome|US Licensed Vaccine|"Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
US Licensed Vaccine: Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid."
80848|NCT01897402|O1|Outcome|Test Vaccine|"NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
Test Vaccine: NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid."
80849|NCT01897402|E2|Reported Event|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
80850|NCT01897402|E1|Reported Event|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
80851|NCT01897285|B1|Baseline|All Participants: AQUACEL® Foam Adhesive Dressings|"Original adhesive + test adhesive
AQUACEL® foam adhesive dressings"
80852|NCT01897285|P1|Participant Flow|All Study Participants|"Original adhesive and Test adhesive on right and left upper arm and right and left lower back.
AQUACEL® foam adhesive dressing Original Adhesive: Arm, Test Adhesive: Arm, Original Adhesive: Back, Test Adhesive: Back"
80855|NCT01897285|O2|Outcome|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive
AQUACEL® foam adhesive dressing"
80856|NCT01897285|O1|Outcome|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive
AQUACEL® foam adhesive dressing"
80857|NCT01897285|E2|Reported Event|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive
AQUACEL® foam adhesive dressing"
80858|NCT01897285|E1|Reported Event|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive
AQUACEL® foam adhesive dressing"
80859|NCT01897233|B1|Baseline|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A Cohort 1: Participants aged 6 through 8 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
Part A Cohort 2: Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
Part B: Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks."
80860|NCT01897233|P1|Participant Flow|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A Cohort 1: Participants aged 6 through 8 years received LUM 200 milligram (mg) in fixed-dose combination with IVA 250 mg orally every 12 hours (q12h) for 14 days.
Part A Cohort 2: Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
Part B: Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks."
80861|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80862|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80863|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80865|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80866|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80867|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80868|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80869|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks
80870|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80871|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80872|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
80873|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
80874|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80875|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
80876|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
80877|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
80878|NCT01897233|E3|Reported Event|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
80879|NCT01897233|E2|Reported Event|Part A Cohort 2: LUM/IVA|Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
80880|NCT01897233|E1|Reported Event|Part A Cohort 1: LUM/IVA|Participants aged 6 through 8 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
80881|NCT01897025|B3|Baseline|Total|Total of all reporting groups
80882|NCT01897025|B2|Baseline|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:
The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.
MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.
real-tDCS with MI-BCI: As in Arm Description"
80883|NCT01897025|B1|Baseline|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.
Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.
After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.
real-tDCS with MI-BCI: As in Arm Description"
80884|NCT01897025|P2|Participant Flow|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:
The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.
MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.
real-tDCS with MI-BCI: As in Arm Description"
80885|NCT01897025|P1|Participant Flow|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.
Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.
After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.
real-tDCS with MI-BCI: As in Arm Description"
80886|NCT01897025|O2|Outcome|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:
The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.
MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.
real-tDCS with MI-BCI: As in Arm Description"
80887|NCT01897025|O1|Outcome|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.
Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.
After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.
real-tDCS with MI-BCI: As in Arm Description"
80920|NCT01896687|B1|Baseline|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
Scrambler: Electrotherapy"
80888|NCT01897025|E2|Reported Event|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:
The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.
MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.
real-tDCS with MI-BCI: As in Arm Description"
80889|NCT01897025|E1|Reported Event|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.
Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.
After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.
real-tDCS with MI-BCI: As in Arm Description"
80890|NCT01896986|B3|Baseline|Total|Total of all reporting groups
80891|NCT01896986|B2|Baseline|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.
Subgroups:
3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy"
80892|NCT01896986|B1|Baseline|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)
Subgroups:
receiving immunosuppressant therapy
not on immunosuppressant therapy"
80893|NCT01896986|P2|Participant Flow|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.
Subgroups:
3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy"
80894|NCT01896986|P1|Participant Flow|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)
Subgroups:
receiving immunosuppressant therapy
not on immunosuppressant therapy"
80895|NCT01896986|O2|Outcome|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.
Subgroups:
3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy
No samples analysed."
80896|NCT01896986|O1|Outcome|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)
Subgroups:
receiving immunosuppressant therapy
not on immunosuppressant therapy
No samples analysed."
80897|NCT01896986|E2|Reported Event|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.
Subgroups:
3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy
no adverse events"
80898|NCT01896986|E1|Reported Event|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)
Subgroups:
receiving immunosuppressant therapy
not on immunosuppressant therapy
no adverse events"
80899|NCT01896934|B1|Baseline|Sertraline|50-200mg daily
80900|NCT01896934|P1|Participant Flow|Sertraline|"50-200mg daily
Sertraline: 50-200mg daily"
80901|NCT01896934|O1|Outcome|Sertraline|"50-200mg daily
Sertraline: 50-200mg daily"
80902|NCT01896934|O1|Outcome|Sertraline|"50-200mg daily
Sertraline: 50-200mg daily"
80903|NCT01896934|O1|Outcome|Sertraline|"50-200mg daily
Sertraline: 50-200mg daily"
80904|NCT01896934|E1|Reported Event|Sertraline|50-200mg daily
80905|NCT01896726|B1|Baseline|Baricitinib + Microgynon|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Days 1 and 29. 10 mg baricitinib tablet administered orally, QD, on Days 23 through 30.
80906|NCT01896726|P1|Participant Flow|Baricitinib + Microgynon|Microgynon tablet [30 micrograms (µg) ethinyl estradiol and 150 µg levonorgestrel] administered orally, once daily (QD), on Days 1 and 29. 10 milligrams (mg) baricitinib tablet administered orally, QD, on Days 23 through 30.
80907|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
80908|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
80909|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
80910|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
80911|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
80912|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
80913|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
80914|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
80915|NCT01896726|E3|Reported Event|Baricitinib + Microgynon|"10 mg baricitinib tablet administered orally, QD, on Days 29 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
Adverse events are reported from postdose on Day 29 up to Day 40."
80916|NCT01896726|E2|Reported Event|Baricitinib|"10 mg baricitinib tablet administered orally, QD, on Days 23 through 28.
Adverse events are reported from postdose on Day 23 through predose on Day 29."
80917|NCT01896726|E1|Reported Event|Microgynon Alone|"Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1.
Adverse events are reported from baseline through predose on Day 23."
80918|NCT01896687|B3|Baseline|Total|Total of all reporting groups
80919|NCT01896687|B2|Baseline|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days
Scrambler: Electrotherapy"
80921|NCT01896687|P2|Participant Flow|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days
Scrambler: Electrotherapy"
80922|NCT01896687|P1|Participant Flow|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
Scrambler: Electrotherapy"
80923|NCT01896687|O2|Outcome|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days
Scrambler: Electrotherapy"
80924|NCT01896687|O1|Outcome|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
Scrambler: Electrotherapy"
80925|NCT01896687|E2|Reported Event|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days
Scrambler: Electrotherapy"
80926|NCT01896687|E1|Reported Event|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
Scrambler: Electrotherapy"
80927|NCT01896557|B3|Baseline|Total|Total of all reporting groups
80928|NCT01896557|B2|Baseline|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
80929|NCT01896557|B1|Baseline|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.
omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
80930|NCT01896557|P2|Participant Flow|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
80931|NCT01896557|P1|Participant Flow|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.
omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
80932|NCT01896557|O2|Outcome|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
80933|NCT01896557|O1|Outcome|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.
omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
80934|NCT01896557|O2|Outcome|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
80935|NCT01896557|O1|Outcome|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.
omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
80936|NCT01896557|E2|Reported Event|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
80937|NCT01896557|E1|Reported Event|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.
omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
80938|NCT01896544|B4|Baseline|Total|Total of all reporting groups
80939|NCT01896544|B3|Baseline|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80940|NCT01896544|B2|Baseline|Placebo|"Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
80941|NCT01896544|B1|Baseline|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80942|NCT01896544|P3|Participant Flow|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80943|NCT01896544|P2|Participant Flow|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80944|NCT01896544|P1|Participant Flow|Placebo|"Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
80945|NCT01896544|O3|Outcome|Cholecalciferol Dose 2|Oral suspension of cholecalciferol 400,000 IU
80946|NCT01896544|O2|Outcome|Cholecalciferol Dose 1|Oral suspension cholecalciferol 200,000 IU
80947|NCT01896544|O1|Outcome|Placebo|Oral suspension of placebo cholecalciferol
80948|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80949|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80950|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
80951|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80952|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80953|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
80954|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80955|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80956|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
80957|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80958|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80959|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
81059|NCT01896050|E1|Reported Event|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
80960|NCT01896544|E3|Reported Event|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80961|NCT01896544|E2|Reported Event|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
80962|NCT01896544|E1|Reported Event|Placebo|"Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
80963|NCT01896297|B1|Baseline|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
80964|NCT01896297|P1|Participant Flow|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
80965|NCT01896297|O1|Outcome|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
80966|NCT01896297|O1|Outcome|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
80967|NCT01896297|E1|Reported Event|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
80968|NCT01896232|B3|Baseline|Total|Total of all reporting groups
80969|NCT01896232|B2|Baseline|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
80970|NCT01896232|B1|Baseline|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
80971|NCT01896232|P2|Participant Flow|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
80972|NCT01896232|P1|Participant Flow|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
80973|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
80974|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
80975|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
80976|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
80996|NCT01896193|B4|Baseline|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
80977|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
80978|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
80979|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
80980|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
81007|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
81008|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
80981|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
80982|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
80983|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
80984|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
80985|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
80986|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
80987|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
80988|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
80989|NCT01896232|E2|Reported Event|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
80990|NCT01896232|E1|Reported Event|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
80991|NCT01896206|B1|Baseline|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.
CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
80992|NCT01896206|P1|Participant Flow|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.
CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
80993|NCT01896206|O1|Outcome|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.
CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
80994|NCT01896206|E1|Reported Event|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.
CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
80995|NCT01896193|B5|Baseline|Total|Total of all reporting groups
81146|NCT01895452|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
80997|NCT01896193|B3|Baseline|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
80998|NCT01896193|B2|Baseline|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
80999|NCT01896193|B1|Baseline|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
81000|NCT01896193|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
81001|NCT01896193|P1|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 16 weeks
81002|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
81003|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
81004|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
81005|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
81006|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
81060|NCT01895946|B3|Baseline|Total|Total of all reporting groups
81009|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
81010|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
81011|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
81012|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
81013|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
81014|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
81015|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
81016|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
81017|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
81018|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
81019|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
81020|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
81021|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
81022|NCT01896193|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
81023|NCT01896193|E1|Reported Event|SOF+RBV 16 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks
81024|NCT01896115|B1|Baseline|All Arms|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
81025|NCT01896115|P1|Participant Flow|All Arms|"Patients with a Vercise DBS system programmed to 30 microseconds pulse width
Patients with a Vercise DBS system programmed to 60 microseconds pulse width
Patients with a Vercise DBS system programmed to steer current ventrally
Patients with a Vercise DBS system programmed to steer current dorsally."
81026|NCT01896115|O4|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
81027|NCT01896115|O3|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
81028|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
81029|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
81030|NCT01896115|O4|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
81031|NCT01896115|O3|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
81032|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
81033|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
81034|NCT01896115|O2|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
81035|NCT01896115|O1|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
81036|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
81037|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
81038|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
81039|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
81040|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
81041|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
81042|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
81043|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
81044|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
81045|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
81046|NCT01896115|E1|Reported Event|All Arms|"Patients with a Vercise DBS system programmed to 4 different settings including:
Short pulse widths (30 microseconds)
Conventional pulse widths (60 microseconds)
Steering current ventrally
Steering current dorsally"
81047|NCT01896050|B3|Baseline|Total|Total of all reporting groups
81048|NCT01896050|B2|Baseline|Tamoxifen|Subjects who started treatment with tamoxifen
81049|NCT01896050|B1|Baseline|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
81050|NCT01896050|P2|Participant Flow|Tamoxifen|Subjects who started treatment with tamoxifen
81051|NCT01896050|P1|Participant Flow|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
81052|NCT01896050|O2|Outcome|Tamoxifen|Tamoxifen-treated patients
81053|NCT01896050|O1|Outcome|Aromatase Inhibitor|Aromatase inhibitor-treated patients
81054|NCT01896050|O2|Outcome|Tamoxifen|Subjects who started treatment with tamoxifen
81055|NCT01896050|O1|Outcome|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
81056|NCT01896050|O2|Outcome|Tamoxifen|Subjects who started treatment with tamoxifen
81081|NCT01895634|B1|Baseline|Treatment|"Intervention Device: Rev-01
Rev-01: Treatment arm patients have used Rev-01 at least once"
81082|NCT01895634|P1|Participant Flow|Treatment|"Intervention Device: Rev-01
Rev-01: Treatment arm patients have used Rev-01 at least once"
81083|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01
Rev-01: Treatment arm patients have used Rev-01 at least once"
81084|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01
Rev-01: Treatment arm patients have used Rev-01 at least once"
81085|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01
Rev-01: Treatment arm patients have used Rev-01 at least once"
81086|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01
Rev-01: Treatment arm patients have used Rev-01 at least once"
81087|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01
Rev-01: Treatment arm patients have used Rev-01 at least once"
81088|NCT01895634|E1|Reported Event|Treatment|"Intervention Device: Rev-01
Rev-01: Treatment arm patients have used Rev-01 at least once"
81089|NCT01895608|B5|Baseline|Total|Total of all reporting groups
81090|NCT01895608|B4|Baseline|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.
Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
81091|NCT01895608|B3|Baseline|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.
Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
81092|NCT01895608|B2|Baseline|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
81137|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81138|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81093|NCT01895608|B1|Baseline|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.
Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
81094|NCT01895608|P4|Participant Flow|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.
Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
81095|NCT01895608|P3|Participant Flow|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.
Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
81096|NCT01895608|P2|Participant Flow|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
81097|NCT01895608|P1|Participant Flow|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.
Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
81098|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.
Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
81193|NCT01895270|B2|Baseline|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.
Placebo: Placebo will consist of microcrystalline cellulose."
82671|NCT01886781|E1|Reported Event|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
81099|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.
Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
81100|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
81101|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.
Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
81102|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.
Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
81103|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.
Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
81104|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
81139|NCT01895543|E1|Reported Event|EBX 10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81105|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.
Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
81106|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.
Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
81107|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.
Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
81108|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
81109|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.
Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
81110|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.
Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
81111|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.
Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
81112|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
81113|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.
Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
81114|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.
Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
81115|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.
Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
81116|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
81140|NCT01895452|B3|Baseline|Total|Total of all reporting groups
81141|NCT01895452|B2|Baseline|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
81117|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.
Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
81118|NCT01895608|O4|Outcome|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.
Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
81119|NCT01895608|O3|Outcome|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.
Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
81120|NCT01895608|O2|Outcome|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
81121|NCT01895608|O1|Outcome|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.
Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
81122|NCT01895608|E4|Reported Event|Cognitive Training (General Cognition)|"General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.
Cognitive training (general cognition): General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation."
81123|NCT01895608|E3|Reported Event|Cognitive Training (Speed of Processing)|"Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.
Cognitive training (speed of processing): Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field."
81124|NCT01895608|E2|Reported Event|Standard Balance Rehabilitation|"Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
Standard balance rehabilitation: Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands."
81125|NCT01895608|E1|Reported Event|Balance Rehabilitation + Dual-task Practice|"Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant can safely perform the primary balance or gait task.
Balance rehabilitation + dual-task practice: Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant"
81126|NCT01895543|B1|Baseline|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81127|NCT01895543|P1|Participant Flow|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81128|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81129|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81130|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81131|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81132|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81133|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81134|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81135|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81136|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg
Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
81142|NCT01895452|B1|Baseline|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
81147|NCT01895452|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
81148|NCT01895452|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
81149|NCT01895452|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
81150|NCT01895452|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
81151|NCT01895452|E2|Reported Event|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
81152|NCT01895452|E1|Reported Event|ALKS 9072, Low|ALKS 9072, Low : IM injection, given monthly
81153|NCT01895335|B1|Baseline|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81154|NCT01895335|P1|Participant Flow|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.
81155|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81156|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81157|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81158|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81159|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81160|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81161|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81162|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81163|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81164|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81165|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81166|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81167|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81168|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81169|NCT01895335|E1|Reported Event|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
81206|NCT01895101|P2|Participant Flow|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
In this arm the subjects receives as in standard care no pericardial lavage."
81252|NCT01894984|E2|Reported Event|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
82672|NCT01886716|B5|Baseline|Total|Total of all reporting groups
81170|NCT01895322|B1|Baseline|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.
- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)
OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
81171|NCT01895322|P1|Participant Flow|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.
- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)
OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
81172|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.
- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)
OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
81173|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.
- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)
OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
81174|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an increase of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.
- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)
OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
81215|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
In this arm the subjects receives as in standard care no pericardial lavage."
81356|NCT01894256|E4|Reported Event|Part B Normal Renal Function|Patients in Part B of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81175|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.
- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)
OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
81176|NCT01895322|E1|Reported Event|OPC-41061|OPC-41061
81177|NCT01895309|B3|Baseline|Total|Total of all reporting groups
81178|NCT01895309|B2|Baseline|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
81179|NCT01895309|B1|Baseline|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
81180|NCT01895309|P2|Participant Flow|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
81181|NCT01895309|P1|Participant Flow|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
81182|NCT01895309|O4|Outcome|Enbrel (Etanercept) at Week 52|"Enbrel 50 mg/week via subcutaneous injection
Enbrel (etanercept)"
81183|NCT01895309|O3|Outcome|SB4 (Proposed Biosimilar to Etanercept) at Week 52|"SB4 50 mg/week via subcutaneous injection
SB4 (proposed biosimilar to etanercept)"
81184|NCT01895309|O2|Outcome|Enbrel (Etanercept) at Week 24|"Enbrel 50 mg/week via subcutaneous injection
Enbrel (etanercept)"
81185|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept) at Week 24|"SB4 50 mg/week via subcutaneous injection
SB4 (proposed biosimilar to etanercept)"
81186|NCT01895309|O2|Outcome|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
81187|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
81188|NCT01895309|O2|Outcome|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
81189|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
81190|NCT01895309|E2|Reported Event|Enbrel (Etanercept)|"Enbrel 50 mg/week via subcutaneous injection
Enbrel (etanercept)"
81191|NCT01895309|E1|Reported Event|SB4 (Proposed Biosimilar to Etanercept)|"SB4 50 mg/week via subcutaneous injection
SB4 (proposed biosimilar to etanercept)"
81192|NCT01895270|B3|Baseline|Total|Total of all reporting groups
81229|NCT01895062|O2|Outcome|no Intervention|Routine care is administered without the application of cNEP.
81194|NCT01895270|B1|Baseline|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.
Isradipine: Isradipine extended release formulation"
81195|NCT01895270|P2|Participant Flow|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.
Placebo: Placebo will consist of microcrystalline cellulose."
81196|NCT01895270|P1|Participant Flow|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.
Isradipine: Isradipine extended release formulation"
81197|NCT01895270|O2|Outcome|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.
Placebo: Placebo will consist of microcrystalline cellulose."
81198|NCT01895270|O1|Outcome|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.
Isradipine: Isradipine extended release formulation"
81199|NCT01895270|E2|Reported Event|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.
Placebo: Placebo will consist of microcrystalline cellulose."
81216|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.
Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
81200|NCT01895270|E1|Reported Event|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.
Isradipine: Isradipine extended release formulation"
81201|NCT01895101|B4|Baseline|Total|Total of all reporting groups
81202|NCT01895101|B3|Baseline|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).
2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
81203|NCT01895101|B2|Baseline|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
In this arm the subjects receives as in standard care no pericardial lavage."
81204|NCT01895101|B1|Baseline|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.
Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
81205|NCT01895101|P3|Participant Flow|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).
2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
81368|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
81207|NCT01895101|P1|Participant Flow|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.
Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
81208|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).
2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
81209|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
In this arm the subjects receives as in standard care no pericardial lavage."
81210|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.
Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
81211|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).
2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
81212|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
In this arm the subjects receives as in standard care no pericardial lavage."
81213|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.
Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
81214|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).
2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
83076|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
81217|NCT01895101|E3|Reported Event|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).
2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
81218|NCT01895101|E2|Reported Event|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
In this arm the subjects receives as in standard care no pericardial lavage."
81219|NCT01895101|E1|Reported Event|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.
Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
81220|NCT01895088|B1|Baseline|Age, Categorical|Measure Type: Count of Participants
81221|NCT01895088|P1|Participant Flow|Patients Prev. Implanted With ACI7000PDT|"Prev. implanted in ACU-P08-020/020A study
AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay"
81222|NCT01895088|O1|Outcome|Patients Prev. Implanted With ACI7000PDT|"Prev. implanted in ACU-P08-020/020A study
AcuFocus Corneal Inlay ACI 7000 PDT: Inlay implanted in cornea for improvement of near vision"
81223|NCT01895088|E1|Reported Event|Patients Prev. Implanted With ACI7000PDT|"Prev. implanted in ACU-P08-020/020A study
AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay"
81224|NCT01895062|B3|Baseline|Total|Total of all reporting groups
81225|NCT01895062|B2|Baseline|no Intervention|Routine care is administered without the application of cNEP.
81226|NCT01895062|B1|Baseline|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.
Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.
The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
81227|NCT01895062|P2|Participant Flow|no Intervention|Routine care is administered without the application of cNEP.
81228|NCT01895062|P1|Participant Flow|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.
Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.
The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
81230|NCT01895062|O1|Outcome|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.
Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.
The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
81231|NCT01895062|O2|Outcome|no Intervention|Routine care is administered without the application of cNEP.
81232|NCT01895062|O1|Outcome|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.
Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.
The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
81233|NCT01895062|E2|Reported Event|no Intervention|Routine care is administered without the application of cNEP.
81234|NCT01895062|E1|Reported Event|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.
Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.
The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
81235|NCT01894984|B3|Baseline|Total|Total of all reporting groups
81236|NCT01894984|B2|Baseline|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
81237|NCT01894984|B1|Baseline|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
81238|NCT01894984|P2|Participant Flow|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
81239|NCT01894984|P1|Participant Flow|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
81240|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
81241|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
81242|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
83077|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
81243|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
81244|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
81245|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
81246|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
81247|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
81248|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
81249|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
81250|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
81251|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
83283|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
81253|NCT01894984|E1|Reported Event|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
81254|NCT01894906|B3|Baseline|Total|Total of all reporting groups
81255|NCT01894906|B2|Baseline|Gambro 17R/21R (Group 2: Polyamide Membrane).|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
81256|NCT01894906|B1|Baseline|Baxter CT-190 (Group 1: Cellulose Triacetate Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
81257|NCT01894906|P2|Participant Flow|Gambro 17R/21R (Group 2: Polyamide Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
81258|NCT01894906|P1|Participant Flow|Baxter CT-190 (Group 1: Cellulose Triacetate Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
81259|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
81260|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
81313|NCT01894256|B2|Baseline|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81261|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81262|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
81263|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81264|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81265|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
81266|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
81369|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
81267|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81268|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
81269|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81270|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81271|NCT01894906|O1|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81272|NCT01894906|O3|Outcome|Baxter and Gambro Combined|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). This category includes the combined results of both groups.
81273|NCT01894906|O2|Outcome|Gambro Polyflux|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane).
81274|NCT01894906|O1|Outcome|Baxter CT-190|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane).
81314|NCT01894256|B1|Baseline|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81275|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
81276|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
81277|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81278|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
81279|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81280|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81281|NCT01894906|E6|Reported Event|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
81282|NCT01894906|E5|Reported Event|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
81283|NCT01894906|E4|Reported Event|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81284|NCT01894906|E3|Reported Event|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
81285|NCT01894906|E2|Reported Event|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81286|NCT01894906|E1|Reported Event|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
81287|NCT01894672|B1|Baseline|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
81288|NCT01894672|P1|Participant Flow|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
81289|NCT01894672|O1|Outcome|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
81290|NCT01894672|O1|Outcome|LGX818|"LGX818 capsules will be administered orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
LGX818"
81291|NCT01894672|O1|Outcome|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
81292|NCT01894672|E1|Reported Event|LGX818|Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
81293|NCT01894607|B1|Baseline|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
83284|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
81294|NCT01894607|P1|Participant Flow|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
81295|NCT01894607|O1|Outcome|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
81296|NCT01894607|O1|Outcome|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
81297|NCT01894607|E1|Reported Event|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
81298|NCT01894581|B3|Baseline|Total|Total of all reporting groups
81299|NCT01894581|B2|Baseline|Normal Weight|BMI 18-25 kg/m2
81300|NCT01894581|B1|Baseline|Obese|BMI >= 30 kg/m2
81301|NCT01894581|P2|Participant Flow|Normal Weight|BMI 18-25 kg/m2
81302|NCT01894581|P1|Participant Flow|Obese|BMI >= 30 kg/m2
81303|NCT01894581|O2|Outcome|Normal Weight|BMI 18-25 kg/m2
81304|NCT01894581|O1|Outcome|Obese|BMI >= 30 kg/m2
81305|NCT01894581|E2|Reported Event|Normal Weight|BMI 18-25 kg/m2
81306|NCT01894581|E1|Reported Event|Obese|BMI >= 30 kg/m2
81307|NCT01894555|B1|Baseline|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.
Aspirin: 81 mg daily for 4 weeks"
81308|NCT01894555|P1|Participant Flow|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.
Aspirin: 81 mg daily for 4 weeks"
81309|NCT01894555|O1|Outcome|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.
Aspirin: 81 mg daily for 4 weeks"
81310|NCT01894555|E1|Reported Event|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.
Aspirin: 81 mg daily for 4 weeks"
81311|NCT01894256|B4|Baseline|Total|Total of all reporting groups
81312|NCT01894256|B3|Baseline|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81335|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81315|NCT01894256|P3|Participant Flow|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81316|NCT01894256|P2|Participant Flow|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81317|NCT01894256|P1|Participant Flow|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81318|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81319|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81320|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81321|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81322|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81323|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81324|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81325|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81326|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81327|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81328|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81329|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81330|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81331|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81332|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81333|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81334|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81583|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
81336|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81337|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81338|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81339|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81340|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81341|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81342|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81343|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81344|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81345|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81346|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81347|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81348|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81349|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81350|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81351|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81352|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81353|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81354|NCT01894256|E6|Reported Event|Part B Moderate Renal Impairment|"Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81355|NCT01894256|E5|Reported Event|Part B Mild Renal Impairment|"Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81659|NCT01892267|E2|Reported Event|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81357|NCT01894256|E3|Reported Event|Part A Moderate Renal Impairment|"Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81358|NCT01894256|E2|Reported Event|Part A Mild Renal Impairment|"Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.
Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
81359|NCT01894256|E1|Reported Event|Part A Normal Renal Function|Patients from Part A of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
81360|NCT01894230|B3|Baseline|Total|Total of all reporting groups
81361|NCT01894230|B2|Baseline|Usual Care Only|"Genetic testing for SLCO1B1*5 allele
Reporting for SLCO1B1*5 allele at the end of study
Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.
Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
81362|NCT01894230|B1|Baseline|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele
Reporting for SLCO1B1*5 allele at randomization
Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization
Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
81363|NCT01894230|P2|Participant Flow|Usual Care Only|"Genetic testing for SLCO1B1*5 allele
Reporting for SLCO1B1*5 allele at the end of study
Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.
Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
81364|NCT01894230|P1|Participant Flow|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele
Reporting for SLCO1B1*5 allele at randomization
Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization
Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
81365|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
81366|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
81367|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
81370|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
81371|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
81372|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
81373|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
81374|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
81375|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
81376|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
81377|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
81378|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
81379|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
81380|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
81381|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
81382|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
81383|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
81384|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
81385|NCT01894230|E2|Reported Event|Usual Care Only|"Genetic testing for SLCO1B1*5 allele
Reporting for SLCO1B1*5 allele at the end of study
Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.
Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
81386|NCT01894230|E1|Reported Event|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele
Reporting for SLCO1B1*5 allele at randomization
Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization
Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
81387|NCT01894100|B3|Baseline|Total|Total of all reporting groups
81412|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81413|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
83078|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
81388|NCT01894100|B2|Baseline|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.
Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
81389|NCT01894100|B1|Baseline|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.
Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
81390|NCT01894100|P2|Participant Flow|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.
Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
81421|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81422|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81391|NCT01894100|P1|Participant Flow|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.
Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
81392|NCT01894100|O2|Outcome|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.
Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
81393|NCT01894100|O1|Outcome|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.
Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
81394|NCT01894100|O2|Outcome|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.
Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
81414|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81415|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81660|NCT01892267|E1|Reported Event|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81395|NCT01894100|O1|Outcome|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.
Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
81396|NCT01894100|E2|Reported Event|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.
Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
81423|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81424|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81599|NCT01892657|O9|Outcome|Patch 9|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
81397|NCT01894100|E1|Reported Event|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.
Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
81398|NCT01894022|B3|Baseline|Total|Total of all reporting groups
81399|NCT01894022|B2|Baseline|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81400|NCT01894022|B1|Baseline|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81401|NCT01894022|P2|Participant Flow|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81402|NCT01894022|P1|Participant Flow|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81403|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81404|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81405|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81406|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81407|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81408|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81409|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81410|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81411|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81416|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81417|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81418|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81419|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81420|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81508|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81425|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81426|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81427|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81428|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81429|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81430|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81431|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81432|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81433|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81434|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81435|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81436|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81437|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81438|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81439|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81440|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81441|NCT01894022|O2|Outcome|Ambrisentan 5 mg|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81442|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81443|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81444|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81445|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81446|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81447|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81448|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81449|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81450|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81451|NCT01894022|E2|Reported Event|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81452|NCT01894022|E1|Reported Event|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
81453|NCT01893905|B3|Baseline|Total|Total of all reporting groups
81454|NCT01893905|B2|Baseline|Placebo|Placebo oral
81455|NCT01893905|B1|Baseline|CS+SG|Chondroitin sulfate+glucosamine sulfate
81456|NCT01893905|P2|Participant Flow|Placebo|Oral Placebo
81457|NCT01893905|P1|Participant Flow|CS+SG|Chondroitin sulfate+ glucosamine sulfate
81458|NCT01893905|O2|Outcome|Placebo|Placebo Oral
81459|NCT01893905|O1|Outcome|CS+SG|Chondroitin sulfate+glucosamine sulfate
81460|NCT01893905|E2|Reported Event|Placebo|Placebo oral
81461|NCT01893905|E1|Reported Event|CS+SG|chondroitin sulfate+glucosamine sulfate
81462|NCT01893879|B3|Baseline|Total|Total of all reporting groups
81463|NCT01893879|B2|Baseline|Placebo for Study Drug|"Patients receive placebo three times daily, orally, for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
placebo for study drug: Given PO
laboratory biomarker analysis: Correlative studies"
81464|NCT01893879|B1|Baseline|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug three times daily, orally, for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
(RS)2-(3-benzoylphenyl)-propionic acid: Given PO
laboratory biomarker analysis: Correlative studies"
81465|NCT01893879|P2|Participant Flow|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
placebo for study drug: Given PO
laboratory biomarker analysis: Correlative studies"
81466|NCT01893879|P1|Participant Flow|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
(RS)2-(3-benzoylphenyl)-propionic acid: Given PO
laboratory biomarker analysis: Correlative studies"
81549|NCT01893359|O3|Outcome|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.
Laser-assisted in situ keratomileusis"
81467|NCT01893879|O2|Outcome|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
placebo for study drug: Given PO
laboratory biomarker analysis: Correlative studies"
81468|NCT01893879|O1|Outcome|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
(RS)2-(3-benzoylphenyl)-propionic acid: Given PO
laboratory biomarker analysis: Correlative studies"
81469|NCT01893879|E2|Reported Event|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
placebo for study drug: Given PO
laboratory biomarker analysis: Correlative studies"
81470|NCT01893879|E1|Reported Event|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed.
(RS)2-(3-benzoylphenyl)-propionic acid: Given PO
laboratory biomarker analysis: Correlative studies"
81471|NCT01893567|B1|Baseline|Clobex Spray|Clobex Spray
81472|NCT01893567|P1|Participant Flow|Clobex Spray|Clobex Spray
81473|NCT01893567|O1|Outcome|Clobex Spray|Clobex Spray
81474|NCT01893567|E1|Reported Event|Clobex Spray|Clobex Spray
81475|NCT01893411|B4|Baseline|Total|Total of all reporting groups
81476|NCT01893411|B3|Baseline|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81477|NCT01893411|B2|Baseline|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81478|NCT01893411|B1|Baseline|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81479|NCT01893411|P3|Participant Flow|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81480|NCT01893411|P2|Participant Flow|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81481|NCT01893411|P1|Participant Flow|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 Unit per kilogram (U/kg) Body Weight (BW) of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81482|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81483|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81484|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81485|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81486|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81487|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81488|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81489|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81490|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81491|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81492|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81493|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81494|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81495|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81496|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81661|NCT01892189|B10|Baseline|Total|Total of all reporting groups
81497|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81498|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81499|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81500|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81501|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81502|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81503|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81504|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81505|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81506|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81507|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
83285|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
81509|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81510|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81511|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81512|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81513|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81514|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81515|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81516|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81517|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81518|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81519|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81520|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81521|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81522|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81523|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81582|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
81524|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81525|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81526|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81527|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81528|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81529|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81530|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81531|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81532|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81533|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81534|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81535|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81536|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
81537|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
81538|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
81539|NCT01893411|E3|Reported Event|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 U per injection treatment via intramuscular injection into spastic muscles.
81540|NCT01893411|E2|Reported Event|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 U per injection treatment via intramuscular injection into spastic muscles.
81541|NCT01893411|E1|Reported Event|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 Unit per kilogram (U/kg) Body Weight (BW) of IncobotulinumtoxinA (Xeomin) with a maximum of 400 U per injection treatment via intramuscular injection into spastic muscles.
81542|NCT01893359|B4|Baseline|Total|Total of all reporting groups
81543|NCT01893359|B3|Baseline|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.
Laser-assisted in situ keratomileusis"
81544|NCT01893359|B2|Baseline|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.
riboflavin ophthalmic solution, 0% dextran
UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
Laser-assisted in situ keratomileusis"
81545|NCT01893359|B1|Baseline|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.
riboflavin ophthalmic solution, 0% dextran
UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
Laser-assisted in situ keratomileusis"
81546|NCT01893359|P3|Participant Flow|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.
Laser-assisted in situ keratomileusis"
81547|NCT01893359|P2|Participant Flow|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.
riboflavin ophthalmic solution, 0% dextran
UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
Laser-assisted in situ keratomileusis"
81548|NCT01893359|P1|Participant Flow|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.
riboflavin ophthalmic solution, 0% dextran
UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
Laser-assisted in situ keratomileusis"
82170|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray
Pain Ease Spray: Cold Spray used to anesthetize the skin"
81550|NCT01893359|O2|Outcome|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.
riboflavin ophthalmic solution, 0% dextran
UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
Laser-assisted in situ keratomileusis"
81551|NCT01893359|O1|Outcome|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.
riboflavin ophthalmic solution, 0% dextran
UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
Laser-assisted in situ keratomileusis"
81552|NCT01893359|O3|Outcome|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.
Laser-assisted in situ keratomileusis"
81553|NCT01893359|O2|Outcome|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.
riboflavin ophthalmic solution, 0% dextran
UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
Laser-assisted in situ keratomileusis"
81554|NCT01893359|O1|Outcome|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.
riboflavin ophthalmic solution, 0% dextran
UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
Laser-assisted in situ keratomileusis"
81555|NCT01893359|E3|Reported Event|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.
Laser-assisted in situ keratomileusis"
81556|NCT01893359|E2|Reported Event|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.
riboflavin ophthalmic solution, 0% dextran
UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
Laser-assisted in situ keratomileusis"
81598|NCT01892657|O10|Outcome|Challenge Patch (Original Site) - 48 Hours|The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded at 48 hours.
81557|NCT01893359|E1|Reported Event|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.
riboflavin ophthalmic solution, 0% dextran
UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
Laser-assisted in situ keratomileusis"
81558|NCT01893346|B5|Baseline|Total|Total of all reporting groups
81559|NCT01893346|B4|Baseline|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.
Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
81560|NCT01893346|B3|Baseline|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.
Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
81561|NCT01893346|B2|Baseline|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
81562|NCT01893346|B1|Baseline|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
81563|NCT01893346|P4|Participant Flow|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.
Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
81564|NCT01893346|P3|Participant Flow|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.
Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
81565|NCT01893346|P2|Participant Flow|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
81566|NCT01893346|P1|Participant Flow|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
81567|NCT01893346|O4|Outcome|Cohort 2 / Ceftazidime|aged ≥6 to <12 years
81568|NCT01893346|O3|Outcome|Cohort 2 / Avibactam|aged ≥6 to <12 years
81569|NCT01893346|O2|Outcome|Cohort 1 / Ceftazidime|aged ≥12 to <18 years / Ceftazidime
81570|NCT01893346|O1|Outcome|Cohort 1 / Avibactam|aged ≥12 to <18 years
81571|NCT01893346|O4|Outcome|Cohort 2 / Ceftazidime|aged ≥6 to <12 years
81572|NCT01893346|O3|Outcome|Cohort 2 / Avibactam|aged ≥6 to <12 years
81573|NCT01893346|O2|Outcome|Cohort 1 / Ceftazidime|aged ≥12 to <18 years / Ceftazidime
81574|NCT01893346|O1|Outcome|Cohort 1 / Avibactam|aged ≥12 to <18 years
81575|NCT01893346|E4|Reported Event|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.
Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
81576|NCT01893346|E3|Reported Event|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.
Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
81577|NCT01893346|E2|Reported Event|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
81578|NCT01893346|E1|Reported Event|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
81579|NCT01893281|B1|Baseline|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
81580|NCT01893281|P1|Participant Flow|Topical Testosterone Solution|Testosterone, initially 60 milligrams (mg) once daily (QD), titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
81581|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
81584|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
81585|NCT01893281|E1|Reported Event|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
81586|NCT01893203|B1|Baseline|BF-200 ALA vs MAL|BF-200 ALA cream and MAL (Metvix, Galderma) used in a randomized split-face design
81587|NCT01893203|P1|Participant Flow|BF200 ALA vs MAL|5-aminulevulinic acid nanoemulsion (BF-200 ALA, Ameluz, Biofrontera) and methylaminolevulinic acid (MAL, Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
81588|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
81589|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
81590|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
81591|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
81592|NCT01893203|E1|Reported Event|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized slipt face design on symmetrical treatment areas.
81593|NCT01892657|B1|Baseline|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
81594|NCT01892657|P1|Participant Flow|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
81595|NCT01892657|O13|Outcome|Challenge Patch (Alternate Site) - 96 Hours|A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded again at 96 hours.
81596|NCT01892657|O12|Outcome|Challenge Patch (Alternate Site) - 48 Hours|A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded at 48 hours.
81597|NCT01892657|O11|Outcome|Challenge Patch (Original Site) - 96 Hours|The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded again at 96 hours.
82850|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
81600|NCT01892657|O8|Outcome|Patch 8|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
81601|NCT01892657|O7|Outcome|Patch 7|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
81602|NCT01892657|O6|Outcome|Patch 6|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
81603|NCT01892657|O5|Outcome|Patch 5|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
81604|NCT01892657|O4|Outcome|Patch 4|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
81605|NCT01892657|O3|Outcome|Patch 3|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
81606|NCT01892657|O2|Outcome|Patch 2|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
81607|NCT01892657|O1|Outcome|Patch 1|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
81608|NCT01892657|E1|Reported Event|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
81609|NCT01892306|B3|Baseline|Total|Total of all reporting groups
81610|NCT01892306|B2|Baseline|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy
Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
81611|NCT01892306|B1|Baseline|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
81612|NCT01892306|P2|Participant Flow|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy
Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
81613|NCT01892306|P1|Participant Flow|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
81614|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy
Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
81615|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
81616|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy
Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
81617|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
81618|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy
Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
81619|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
81620|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy
Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
82360|NCT01889797|B3|Baseline|Total|Total of all reporting groups
81621|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
81622|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy
Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
81623|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
81624|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy
Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
81625|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
81626|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy
Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
81627|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
81628|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy
Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
81629|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
81630|NCT01892306|E2|Reported Event|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy
Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
81631|NCT01892306|E1|Reported Event|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
81632|NCT01892267|B3|Baseline|Total|Total of all reporting groups
81633|NCT01892267|B2|Baseline|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81634|NCT01892267|B1|Baseline|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81715|NCT01892189|E3|Reported Event|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81635|NCT01892267|P2|Participant Flow|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81636|NCT01892267|P1|Participant Flow|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81637|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81638|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81639|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81640|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81641|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81642|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81643|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81644|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81645|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81646|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81647|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81648|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81649|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81650|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81651|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81652|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81653|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81654|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81655|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81656|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81657|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement"
81658|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement"
81662|NCT01892189|B9|Baseline|TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81663|NCT01892189|B8|Baseline|TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81664|NCT01892189|B7|Baseline|Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81665|NCT01892189|B6|Baseline|TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81713|NCT01892189|E5|Reported Event|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
81714|NCT01892189|E4|Reported Event|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81666|NCT01892189|B5|Baseline|TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81667|NCT01892189|B4|Baseline|Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81668|NCT01892189|B3|Baseline|TAK-063 30 mg + Placebo + TAK-063 3 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81669|NCT01892189|B2|Baseline|TAK-063 3 mg + TAK-063 30 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81670|NCT01892189|B1|Baseline|Placebo + TAK-063 3 mg + TAK-063 30 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81671|NCT01892189|P9|Participant Flow|TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81672|NCT01892189|P8|Participant Flow|TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81697|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
83079|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
81673|NCT01892189|P7|Participant Flow|Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81674|NCT01892189|P6|Participant Flow|TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81675|NCT01892189|P5|Participant Flow|TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81676|NCT01892189|P4|Participant Flow|Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81677|NCT01892189|P3|Participant Flow|TAK-063 30 mg + Placebo + TAK-063 3 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81678|NCT01892189|P2|Participant Flow|TAK-063 3 mg + TAK-063 30 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81679|NCT01892189|P1|Participant Flow|Placebo + TAK-063 3 mg + TAK-063 30 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
81680|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
81681|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81682|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81683|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81684|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81685|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
81686|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81687|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81688|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81689|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81690|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
81691|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81692|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81693|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81694|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81695|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
81696|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81698|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81699|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81700|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81701|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81702|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81703|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81704|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81705|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81706|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81707|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81708|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81709|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81710|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
81711|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81712|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
83286|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
81716|NCT01892189|E2|Reported Event|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81717|NCT01892189|E1|Reported Event|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
81718|NCT01892163|B3|Baseline|Total|Total of all reporting groups
81719|NCT01892163|B2|Baseline|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
81720|NCT01892163|B1|Baseline|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing
Ozurdex: Dexamethasone implant (Ozurdex)"
81721|NCT01892163|P2|Participant Flow|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
81722|NCT01892163|P1|Participant Flow|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing
Ozurdex: Dexamethasone implant (Ozurdex)"
81723|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
81724|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing
Ozurdex: Dexamethasone implant (Ozurdex)"
81725|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
81726|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing
Ozurdex: Dexamethasone implant (Ozurdex)"
81727|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
81728|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing
Ozurdex: Dexamethasone implant (Ozurdex)"
81729|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
81730|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing
Ozurdex: Dexamethasone implant (Ozurdex)"
81731|NCT01892163|E2|Reported Event|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
81732|NCT01892163|E1|Reported Event|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing
Ozurdex: Dexamethasone implant (Ozurdex)"
81733|NCT01892020|B1|Baseline|All Subjects|In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). Group B received BHI 50 BID during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG).
81734|NCT01892020|P2|Participant Flow|Group B (BHI 50 - BIAsp 50)|"In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.
Group B received BHI 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG)."
81794|NCT01891669|B9|Baseline|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81735|NCT01892020|P1|Participant Flow|Group A (BIAsp 50 - BHI 50)|"In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.
Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG)."
81736|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
81737|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
81738|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
81739|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
81740|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
81741|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
81742|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
81743|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
81744|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
81745|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
81746|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
81747|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
81748|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
81749|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
81750|NCT01892020|E2|Reported Event|BHI 50|This arm included the subjects received BHI 50.
81751|NCT01892020|E1|Reported Event|BIAsp 50|This arm included the subjects received BIAsp 50.
81752|NCT01891864|B3|Baseline|Total|Total of all reporting groups
81753|NCT01891864|B2|Baseline|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
Enbrel ® Etanercept"
81754|NCT01891864|B1|Baseline|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
GP2015 Etanercept"
82949|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
81755|NCT01891864|P6|Participant Flow|Enbrel ® Etanercept Switched|"Enbrel ®/GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).
GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81756|NCT01891864|P5|Participant Flow|GP2015 Etanercept Switched|"GP2015/Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).
Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81757|NCT01891864|P4|Participant Flow|Enbrel ® Etanercept Continued|Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2) Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.
81758|NCT01891864|P3|Participant Flow|GP2015 Etanercept Continued|"GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2).
GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2"
81759|NCT01891864|P2|Participant Flow|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
Enbrel ® Etanercept"
81760|NCT01891864|P1|Participant Flow|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
GP2015 Etanercept"
81761|NCT01891864|O4|Outcome|Enbrel ® Etanercept Continued|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).
Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81762|NCT01891864|O3|Outcome|GP2015 Etanercept Switched|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).
Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81763|NCT01891864|O2|Outcome|Enbrel ® Etanercept Switched|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).
GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81764|NCT01891864|O1|Outcome|GP2015 Etanercept Continued|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).
GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81765|NCT01891864|O4|Outcome|Enbrel ® Etanercept Continued|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).
Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81766|NCT01891864|O3|Outcome|GP2015 Etanercept Switched|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).
Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81767|NCT01891864|O2|Outcome|Enbrel ® Etanercept Switched|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).
GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81768|NCT01891864|O1|Outcome|GP2015 Etanercept Continued|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).
GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81769|NCT01891864|O2|Outcome|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
Enbrel ® Etanercept"
81770|NCT01891864|O1|Outcome|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
GP2015 Etanercept"
81771|NCT01891864|O2|Outcome|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
Enbrel ® Etanercept"
81772|NCT01891864|O1|Outcome|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
GP2015 Etanercept"
81773|NCT01891864|O2|Outcome|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
Enbrel ® Etanercept"
81774|NCT01891864|O1|Outcome|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
GP2015 Etanercept"
81775|NCT01891864|E4|Reported Event|Enbrel ® Etanercept Continued|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).
Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81776|NCT01891864|E3|Reported Event|GP2015 Etanercept Switched|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).
Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81777|NCT01891864|E2|Reported Event|Enbrel ® Etanercept Switched|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).
GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81778|NCT01891864|E1|Reported Event|GP2015 Etanercept Continued|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.
GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).
GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
81779|NCT01891734|B3|Baseline|Total|Total of all reporting groups
81780|NCT01891734|B2|Baseline|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
81781|NCT01891734|B1|Baseline|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
81782|NCT01891734|P2|Participant Flow|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
81795|NCT01891669|B8|Baseline|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81783|NCT01891734|P1|Participant Flow|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
81784|NCT01891734|O2|Outcome|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
81785|NCT01891734|O1|Outcome|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.
Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
81786|NCT01891734|O2|Outcome|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
81787|NCT01891734|O1|Outcome|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.
Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
81788|NCT01891734|O2|Outcome|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
81789|NCT01891734|O1|Outcome|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
81790|NCT01891734|E2|Reported Event|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
81791|NCT01891734|E1|Reported Event|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.
Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
81792|NCT01891669|B11|Baseline|Total|Total of all reporting groups
81793|NCT01891669|B10|Baseline|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81796|NCT01891669|B7|Baseline|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81797|NCT01891669|B6|Baseline|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81798|NCT01891669|B5|Baseline|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81799|NCT01891669|B4|Baseline|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81800|NCT01891669|B3|Baseline|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81801|NCT01891669|B2|Baseline|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81802|NCT01891669|B1|Baseline|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81803|NCT01891669|P10|Participant Flow|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81804|NCT01891669|P9|Participant Flow|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81805|NCT01891669|P8|Participant Flow|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81806|NCT01891669|P7|Participant Flow|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
82015|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81807|NCT01891669|P6|Participant Flow|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81808|NCT01891669|P5|Participant Flow|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81809|NCT01891669|P4|Participant Flow|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81810|NCT01891669|P3|Participant Flow|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81811|NCT01891669|P2|Participant Flow|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81812|NCT01891669|P1|Participant Flow|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81813|NCT01891669|O9|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81814|NCT01891669|O8|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81815|NCT01891669|O7|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81816|NCT01891669|O6|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81817|NCT01891669|O5|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81818|NCT01891669|O4|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81819|NCT01891669|O3|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81820|NCT01891669|O2|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81821|NCT01891669|O1|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81822|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81823|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81824|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81825|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81826|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81827|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81828|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81829|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81830|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81831|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81832|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81833|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81834|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81835|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81836|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81837|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81838|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81839|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81840|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81841|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81842|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81843|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81844|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81845|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81846|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81847|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81848|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81849|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81850|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81851|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81852|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81853|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81854|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81855|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81856|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81857|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81858|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81859|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81860|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81861|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81862|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81863|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81864|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81865|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81866|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81867|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81868|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81869|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81870|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81871|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81872|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81873|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81874|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81875|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81876|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81877|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81878|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81879|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81880|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81881|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81882|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81883|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81884|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81885|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81886|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81887|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81888|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81889|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81890|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81891|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81892|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81893|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81894|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81895|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81896|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81897|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81898|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81899|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81900|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81901|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81902|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81903|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81904|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81905|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81906|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81907|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81908|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81909|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81910|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81911|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81912|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81913|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81914|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81915|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81916|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81917|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81918|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81919|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81920|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81921|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81922|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81923|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81924|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81925|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81926|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81927|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81928|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81929|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81930|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81931|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81932|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81933|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81934|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81935|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81936|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81937|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81938|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81939|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81940|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
83080|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
81941|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81942|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81943|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81944|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81945|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81946|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81947|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81948|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81949|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81950|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81982|NCT01890967|O4|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81951|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81952|NCT01891669|E10|Reported Event|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81953|NCT01891669|E9|Reported Event|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81954|NCT01891669|E8|Reported Event|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81955|NCT01891669|E7|Reported Event|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81956|NCT01891669|E6|Reported Event|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81957|NCT01891669|E5|Reported Event|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81958|NCT01891669|E4|Reported Event|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81959|NCT01891669|E3|Reported Event|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81960|NCT01891669|E2|Reported Event|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81961|NCT01891669|E1|Reported Event|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
81962|NCT01890967|B7|Baseline|Total|Total of all reporting groups
81963|NCT01890967|B6|Baseline|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81964|NCT01890967|B5|Baseline|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81965|NCT01890967|B4|Baseline|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81966|NCT01890967|B3|Baseline|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81967|NCT01890967|B2|Baseline|20 mg LY3015014 Q4W|"20 mg LY3015014 given subcutaneously SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81968|NCT01890967|B1|Baseline|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81969|NCT01890967|P6|Participant Flow|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81970|NCT01890967|P5|Participant Flow|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81971|NCT01890967|P4|Participant Flow|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81972|NCT01890967|P3|Participant Flow|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81973|NCT01890967|P2|Participant Flow|20 mg LY3015014 Q4W|"20 milligrams (mg) LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81974|NCT01890967|P1|Participant Flow|Placebo Q4W|"Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81975|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81976|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81977|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81978|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81979|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81980|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81981|NCT01890967|O5|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81983|NCT01890967|O3|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81984|NCT01890967|O2|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81985|NCT01890967|O1|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81986|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81987|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81988|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81989|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81990|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81991|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81992|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81993|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81994|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81995|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81996|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81997|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81998|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
81999|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82000|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82001|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82002|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
83081|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
82003|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82004|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82005|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82006|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82007|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82008|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82009|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82010|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82011|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82012|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82013|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82014|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82016|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82017|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82018|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82019|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82020|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82021|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82022|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82023|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82024|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82025|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82026|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82027|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82028|NCT01890967|O6|Outcome|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82029|NCT01890967|O5|Outcome|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82030|NCT01890967|O4|Outcome|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82031|NCT01890967|O3|Outcome|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82032|NCT01890967|O2|Outcome|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82033|NCT01890967|O1|Outcome|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82034|NCT01890967|E6|Reported Event|300 mg LY3015014 Q8W|"300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82035|NCT01890967|E5|Reported Event|100 mg LY3015014 Q8W|"100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82036|NCT01890967|E4|Reported Event|300 mg LY3015014 Q4W|"300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82037|NCT01890967|E3|Reported Event|120 mg LY3015014 Q4W|"120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82038|NCT01890967|E2|Reported Event|20 mg LY3015014 Q4W|"20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82039|NCT01890967|E1|Reported Event|Placebo Q4W|"Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe."
82040|NCT01890954|B3|Baseline|Total|Total of all reporting groups
82041|NCT01890954|B2|Baseline|Closed Loop Control First, Then Usual Care|8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
82042|NCT01890954|B1|Baseline|Usual Care First, Then Closed Loop Control|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
82043|NCT01890954|P2|Participant Flow|Closed Loop Control First, Then Usual Care|8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
82071|NCT01890785|P4|Participant Flow|Sequence 4|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
82044|NCT01890954|P1|Participant Flow|Usual Care First, Then Closed Loop Control|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
82045|NCT01890954|O2|Outcome|Usual Care Without DiAs System (CGM Only)|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
82046|NCT01890954|O1|Outcome|Closed Loop Control With DiAs System|8 hours observational (09:00-17:00) during closed-loop control (DiAs) with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
82047|NCT01890954|E2|Reported Event|Usual Care Without DiAs System (CGM Only)|8 hours observational under both, missed insulin bolus for 30 gr carbohydrates snack and under bolus for an 80 gr carbohydrates lunch.
82048|NCT01890954|E1|Reported Event|Closed Loop Control With DiAs System|"8 hours using Closed Loop Control with DiAs under both, miss insulin bolus for 30 grams of carbohydrates snack or under bolus for an 80 grams of carbohydrates lunch
Diabetes Assistant (DiAs)"
82049|NCT01890915|B3|Baseline|Total|Total of all reporting groups
82050|NCT01890915|B2|Baseline|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82051|NCT01890915|B1|Baseline|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82052|NCT01890915|P2|Participant Flow|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82053|NCT01890915|P1|Participant Flow|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, American Spinal Injury Association (ASIA) impairment levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82054|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82055|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82056|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82057|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82058|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82059|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82060|NCT01890915|E2|Reported Event|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82061|NCT01890915|E1|Reported Event|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
82062|NCT01890785|B7|Baseline|Total|Total of all reporting groups
82063|NCT01890785|B6|Baseline|Sequence 6|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
82425|NCT01889251|E1|Reported Event|Ocriplasmin|Single intravitreal injection to the study eye at baseline
82064|NCT01890785|B5|Baseline|Sequence 5|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
82065|NCT01890785|B4|Baseline|Sequence 4|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
82066|NCT01890785|B3|Baseline|Sequence 3|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
82067|NCT01890785|B2|Baseline|Sequence 2|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
82068|NCT01890785|B1|Baseline|Sequence 1|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
82069|NCT01890785|P6|Participant Flow|Sequence 6|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
82070|NCT01890785|P5|Participant Flow|Sequence 5|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
82102|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82072|NCT01890785|P3|Participant Flow|Sequence 3|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
82073|NCT01890785|P2|Participant Flow|Sequence 2|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
82074|NCT01890785|P1|Participant Flow|Sequence 1|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
82075|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
82076|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
82077|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
82078|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
82079|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
82080|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
82081|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
82082|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
82083|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
82084|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
82085|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
82086|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
82087|NCT01890785|E3|Reported Event|Lisdexamfetamine Dimesylate Intact Capsule Fasting|Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
82088|NCT01890785|E2|Reported Event|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt(Single dose of a 70 mg capsule on Day 1)
82089|NCT01890785|E1|Reported Event|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
82090|NCT01890759|B3|Baseline|Total|Total of all reporting groups
82091|NCT01890759|B2|Baseline|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82092|NCT01890759|B1|Baseline|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82167|NCT01890642|P2|Participant Flow|Pain Ease|"This group will receive Pain Ease Spray
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82093|NCT01890759|P2|Participant Flow|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82094|NCT01890759|P1|Participant Flow|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82095|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82096|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82097|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82098|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82099|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82100|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82101|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82213|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
82103|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82104|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82105|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82106|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82107|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82108|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82109|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82110|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82111|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82112|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82113|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82114|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82115|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82116|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82117|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82118|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82119|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82876|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82120|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82121|NCT01890759|O2|Outcome|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82122|NCT01890759|O1|Outcome|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82123|NCT01890759|E2|Reported Event|India|Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82124|NCT01890759|E1|Reported Event|Russian Federation|Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
82125|NCT01890746|B3|Baseline|Total|Total of all reporting groups
82126|NCT01890746|B2|Baseline|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82175|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
1% buffered lidocaine: Lidocaine placed using Jet Injection
placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
82176|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82214|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
82127|NCT01890746|B1|Baseline|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82128|NCT01890746|P2|Participant Flow|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82129|NCT01890746|P1|Participant Flow|Eltrombopag (ELT) QD|Par. received (rec) first line induction (IDN) chemotherapy (CTY) consisting of daunorubicin (DAU) bolus intravenous (IV) infusion (INF) on Days (D) 1-3 at a dose of 90 milligrams (mg)/square meter (m^2) for Par. 18-60 year (yr) or 60 mg/m^2 for >60 yr plus cytarabine (CB) 100 mg/m^2 continuous IV INF on D1-7. Par. rec ELT as 200 mg (100 mg for East-Asian Heritage [EAH]) once daily (QD) oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If platelet (PT) count was not >100 Giga (Gi)/Liter (L) after 7D the dose was increased to 300 mg (150 mg for EAH) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42D from the start of the CTY IDN cycle. Par. not aplastic after first cycle of IDN CTY rec re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus CB 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82130|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82131|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82132|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82133|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82134|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82135|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82136|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82177|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82215|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
82216|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
82137|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82138|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82139|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82140|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82141|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82142|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82143|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82144|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82168|NCT01890642|P1|Participant Flow|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82169|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
1% buffered lidocaine: Lidocaine placed using Jet Injection
placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
82145|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82146|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82147|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82148|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
82149|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82150|NCT01890746|E2|Reported Event|Placebo QD|Participants received first line induction chemotherapy consisted of daunorubicin bolus IV infusion on Days 1 – 3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants &gt;60 years of age plus cytarabine continuous IV infusion on Days 1 – 7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose started on Day 4 of initial induction chemotherapy at least 20 hours after end of Day 3 daunorubicin infusion up to a maximum duration of 42 days.
82151|NCT01890746|E1|Reported Event|Eltrombopag QD|Par. received IDN CTY of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.&gt;60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg QD oral dose started on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not &gt;100 Gi/L after 7 days the dose was increased to 300 mg QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par.who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
82152|NCT01890694|B3|Baseline|Total|Total of all reporting groups
82153|NCT01890694|B2|Baseline|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
82154|NCT01890694|B1|Baseline|Placebo|Subjects will receive placebo once daily.
82155|NCT01890694|P2|Participant Flow|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
82156|NCT01890694|P1|Participant Flow|Placebo|Subjects will receive placebo once daily.
82157|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
82158|NCT01890694|O2|Outcome|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
82159|NCT01890694|O1|Outcome|Placebo|Subjects will receive placebo once daily.
82160|NCT01890694|E2|Reported Event|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
82161|NCT01890694|E1|Reported Event|Placebo|Subjects will receive placebo once daily.
82162|NCT01890642|B4|Baseline|Total|Total of all reporting groups
82163|NCT01890642|B3|Baseline|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
1% buffered lidocaine: Lidocaine placed using Jet Injection
placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
82164|NCT01890642|B2|Baseline|Pain Ease|"This group will receive Pain Ease Spray
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82165|NCT01890642|B1|Baseline|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82166|NCT01890642|P3|Participant Flow|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
1% buffered lidocaine: Lidocaine placed using Jet Injection
placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
82171|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82172|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
1% buffered lidocaine: Lidocaine placed using Jet Injection
placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
82173|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82174|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82258|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
82178|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
1% buffered lidocaine: Lidocaine placed using Jet Injection
placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
82179|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82180|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82181|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
1% buffered lidocaine: Lidocaine placed using Jet Injection
placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
82182|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82183|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82184|NCT01890642|E3|Reported Event|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
1% buffered lidocaine: Lidocaine placed using Jet Injection
placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
82185|NCT01890642|E2|Reported Event|Pain Ease|"This group will receive Pain Ease Spray
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82186|NCT01890642|E1|Reported Event|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray
J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Pain Ease Spray: Cold Spray used to anesthetize the skin"
82187|NCT01890577|B1|Baseline|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82188|NCT01890577|P1|Participant Flow|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82189|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82190|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82191|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82192|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82193|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82194|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82195|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82196|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82197|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82198|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82199|NCT01890577|E1|Reported Event|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
82200|NCT01890512|B1|Baseline|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
82201|NCT01890512|P1|Participant Flow|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
82202|NCT01890512|O1|Outcome|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
82203|NCT01890512|E1|Reported Event|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
82204|NCT01890473|B3|Baseline|Total|Total of all reporting groups
82205|NCT01890473|B2|Baseline|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
82206|NCT01890473|B1|Baseline|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
82207|NCT01890473|P2|Participant Flow|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
82208|NCT01890473|P1|Participant Flow|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
82209|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
82210|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
82211|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
82212|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
82217|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
82218|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
82219|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
82220|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
82221|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
82222|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
82223|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
82224|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
82225|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
82226|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
82227|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
82228|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
82229|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
82230|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
82231|NCT01890473|E2|Reported Event|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a PFS.
82232|NCT01890473|E1|Reported Event|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
82233|NCT01890343|B4|Baseline|Total|Total of all reporting groups
82234|NCT01890343|B3|Baseline|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
82235|NCT01890343|B2|Baseline|Cognitively Normal|"Cognitively normal (CN) subjects.
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
82236|NCT01890343|B1|Baseline|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
82237|NCT01890343|P3|Participant Flow|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
82238|NCT01890343|P2|Participant Flow|Cognitively Normal|"Cognitively normal (CN) subjects.
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
82239|NCT01890343|P1|Participant Flow|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
82240|NCT01890343|O3|Outcome|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
82880|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82241|NCT01890343|O2|Outcome|Cognitively Normal|"Cognitively normal (CN) subjects.
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
82242|NCT01890343|O1|Outcome|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
82243|NCT01890343|O3|Outcome|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
82244|NCT01890343|O2|Outcome|Cognitively Normal|"Cognitively normal (CN) subjects.
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
82245|NCT01890343|O1|Outcome|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
82246|NCT01890343|E3|Reported Event|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
82247|NCT01890343|E2|Reported Event|Cognitively Normal|"Cognitively normal (CN) subjects.
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
82248|NCT01890343|E1|Reported Event|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
82249|NCT01890148|B1|Baseline|AZD5069|AZD5069 45mg oral twice daily (BID)
82250|NCT01890148|P1|Participant Flow|AZD5069|AZD5069 45mg oral twice daily (BID)
82251|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
82252|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
82253|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
82254|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
82255|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
82256|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
82257|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
82266|NCT01890122|B4|Baseline|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82267|NCT01890122|B3|Baseline|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82268|NCT01890122|B2|Baseline|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82269|NCT01890122|B1|Baseline|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82270|NCT01890122|P4|Participant Flow|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82271|NCT01890122|P3|Participant Flow|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82272|NCT01890122|P2|Participant Flow|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82273|NCT01890122|P1|Participant Flow|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82274|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82275|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82276|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82277|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82278|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
83082|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
82279|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82280|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82281|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82282|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82283|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82284|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82285|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82286|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82287|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82288|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82289|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82290|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82344|NCT01890031|P1|Participant Flow|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
83287|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
82291|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82292|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82293|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82294|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82295|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82296|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82297|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82298|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82299|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82300|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82301|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82302|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82303|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82304|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
83083|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
82305|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82306|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82307|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82308|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82309|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82310|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82311|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82312|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82313|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82314|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82315|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82316|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82317|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82318|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82319|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82320|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82321|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82322|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82323|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82324|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82325|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82326|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82327|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82328|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82329|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82330|NCT01890122|E4|Reported Event|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
83084|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
82331|NCT01890122|E3|Reported Event|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
82332|NCT01890122|E2|Reported Event|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
82333|NCT01890122|E1|Reported Event|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
82334|NCT01890031|B6|Baseline|Total|Total of all reporting groups
82335|NCT01890031|B5|Baseline|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
82336|NCT01890031|B4|Baseline|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool
Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.
Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
82337|NCT01890031|B3|Baseline|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool
Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
82338|NCT01890031|B2|Baseline|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
82339|NCT01890031|B1|Baseline|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
82340|NCT01890031|P5|Participant Flow|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
82341|NCT01890031|P4|Participant Flow|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool
Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.
Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
82342|NCT01890031|P3|Participant Flow|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool
Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
82343|NCT01890031|P2|Participant Flow|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
82345|NCT01890031|O5|Outcome|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
82346|NCT01890031|O4|Outcome|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool
Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.
Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
82347|NCT01890031|O3|Outcome|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool
Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
82348|NCT01890031|O2|Outcome|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
82349|NCT01890031|O1|Outcome|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
82350|NCT01890031|O5|Outcome|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
82351|NCT01890031|O4|Outcome|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool
Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.
Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
82352|NCT01890031|O3|Outcome|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool
Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
82353|NCT01890031|O2|Outcome|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
82354|NCT01890031|O1|Outcome|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
82355|NCT01890031|E5|Reported Event|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
82356|NCT01890031|E4|Reported Event|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool
Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.
Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
82357|NCT01890031|E3|Reported Event|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool
Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
82358|NCT01890031|E2|Reported Event|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
82359|NCT01890031|E1|Reported Event|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
82361|NCT01889797|B2|Baseline|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.
Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
82362|NCT01889797|B1|Baseline|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.
Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
82363|NCT01889797|P2|Participant Flow|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.
Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
82364|NCT01889797|P1|Participant Flow|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.
Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
82365|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.
Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
82366|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.
Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
82367|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.
Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
82368|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.
Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
82369|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.
Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
82370|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.
Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
82371|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.
Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
82372|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.
Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
82373|NCT01889797|E2|Reported Event|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.
Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
82374|NCT01889797|E1|Reported Event|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.
Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
82375|NCT01889667|B4|Baseline|Total|Total of all reporting groups
82376|NCT01889667|B3|Baseline|Placebo|"Oil Capsules
Placebo: Oil Capsules"
82377|NCT01889667|B2|Baseline|ORMD-0801 Dose # 2|"Oral Insulin Formulation
ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
82378|NCT01889667|B1|Baseline|ORMD-0801 Dose # 1|"Oral Insulin Formulation
ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
82379|NCT01889667|P3|Participant Flow|Placebo|"Oil Capsules
Placebo: Oil Capsules"
82380|NCT01889667|P2|Participant Flow|ORMD-0801 Dose # 2|"Oral Insulin Formulation
ORMD-0801 Dose # 2: Oral Insulin Formulation"
82381|NCT01889667|P1|Participant Flow|ORMD-0801 Dose # 1|"Oral Insulin Formulation
ORMD-0801 Dose # 1: Oral Insulin Formulation"
82382|NCT01889667|O3|Outcome|Placebo|"Oil Capsules
Placebo: Oil Capsules"
82383|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation
ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
82384|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation
ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
82386|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation
ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
82387|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation
ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
82388|NCT01889667|O3|Outcome|Placebo|"Oil Capsules
Placebo: Oil Capsules"
82389|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation
ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
82390|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation
ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
82391|NCT01889667|O3|Outcome|Placebo|"Oil Capsules
Placebo: Oil Capsules"
82392|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation
ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
82393|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation
ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
82394|NCT01889667|O3|Outcome|Placebo|"Oil Capsules
Placebo: Oil Capsules"
82395|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation
ORMD-0801 Dose # 2: Oral Insulin Formulation"
82396|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation
ORMD-0801 Dose # 1: Oral Insulin Formulation"
82397|NCT01889667|E3|Reported Event|Placebo|"Oil Capsules
Placebo: Oil Capsules"
82398|NCT01889667|E2|Reported Event|ORMD-0801 Dose # 2|"Oral Insulin Formulation
ORMD-0801 Dose # 2: Oral Insulin Formulation (24 mg)"
82399|NCT01889667|E1|Reported Event|ORMD-0801 Dose # 1|"Oral Insulin Formulation
ORMD-0801 Dose # 1: Oral Insulin Formulation (16 mg)"
82400|NCT01889563|B3|Baseline|Total|Total of all reporting groups
82401|NCT01889563|B2|Baseline|No Physical Exercise Training Program|No Physical Exercise Training Program
82402|NCT01889563|B1|Baseline|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
82403|NCT01889563|P2|Participant Flow|No Physical Exercise Training Program|No Physical Exercise Training Program
82404|NCT01889563|P1|Participant Flow|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
82405|NCT01889563|O2|Outcome|No Physical Exercise Training Program|No Physical Exercise Training Program
82426|NCT01888965|B1|Baseline|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years
Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
82406|NCT01889563|O1|Outcome|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
82407|NCT01889563|O2|Outcome|No Physical Exercise Training Program|No Physical Exercise Training Program
82408|NCT01889563|O1|Outcome|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
82409|NCT01889563|E2|Reported Event|No Physical Exercise Training Program|No Physical Exercise Training Program
82410|NCT01889563|E1|Reported Event|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
82411|NCT01889420|B1|Baseline|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle
Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.
Cycles will span 28 days. Dosage schedules will be:
Everolimus daily for 28 days of a 28 day cycle;
Pomalidomide daily for 21 days of a 28 day cycle
Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
82412|NCT01889420|P1|Participant Flow|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle
Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.
Cycles will span 28 days. Dosage schedules will be:
Everolimus daily for 28 days of a 28 day cycle;
Pomalidomide daily for 21 days of a 28 day cycle
Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
83288|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
82413|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle
Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.
Cycles will span 28 days. Dosage schedules will be:
Everolimus daily for 28 days of a 28 day cycle;
Pomalidomide daily for 21 days of a 28 day cycle
Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
82414|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle
Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.
Cycles will span 28 days. Dosage schedules will be:
Everolimus daily for 28 days of a 28 day cycle;
Pomalidomide daily for 21 days of a 28 day cycle
Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
82415|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle
Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.
Cycles will span 28 days. Dosage schedules will be:
Everolimus daily for 28 days of a 28 day cycle;
Pomalidomide daily for 21 days of a 28 day cycle
Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
82416|NCT01889420|E1|Reported Event|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle
Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.
Cycles will span 28 days. Dosage schedules will be:
Everolimus daily for 28 days of a 28 day cycle;
Pomalidomide daily for 21 days of a 28 day cycle
Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
82417|NCT01889251|B3|Baseline|Total|Total of all reporting groups
82418|NCT01889251|B2|Baseline|Sham Injection|Single sham injection to the study eye at baseline
82419|NCT01889251|B1|Baseline|Ocriplasmin|Single intravitreal injection to the study eye at baseline
82420|NCT01889251|P2|Participant Flow|Sham Injection|Single sham injection to the study eye at baseline
82421|NCT01889251|P1|Participant Flow|Ocriplasmin|Single intravitreal injection to the study eye at baseline
82422|NCT01889251|O2|Outcome|Sham Injection|Single sham injection to the study eye at baseline
82423|NCT01889251|O1|Outcome|Ocriplasmin|Single intravitreal injection to the study eye at baseline
82424|NCT01889251|E2|Reported Event|Sham Injection|Single sham injection to the study eye at baseline
83085|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
82427|NCT01888965|P1|Participant Flow|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years
Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
82428|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years
Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
82429|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years
Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
82430|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years
Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
82431|NCT01888965|E1|Reported Event|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years
Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
82432|NCT01888952|B1|Baseline|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).
In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.
In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.
Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.
Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
82433|NCT01888952|P1|Participant Flow|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).
In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.
In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.
Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.
Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
82466|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
82434|NCT01888952|O1|Outcome|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).
In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.
In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.
Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.
Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
82435|NCT01888952|E1|Reported Event|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).
In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.
In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.
Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.
Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
82436|NCT01888900|B3|Baseline|Total|Total of all reporting groups
82437|NCT01888900|B2|Baseline|Hepatitis C Virus Genotype 1B|Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
82438|NCT01888900|B1|Baseline|Hepatitis C Virus Genotype 1A|subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
82439|NCT01888900|P2|Participant Flow|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
82440|NCT01888900|P1|Participant Flow|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
82441|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
82442|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
82443|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
82444|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
82445|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
82446|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
82447|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
82448|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
82449|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
82450|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
82451|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
82452|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
82453|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
82454|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
82455|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
82456|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
82457|NCT01888900|E2|Reported Event|Hepatitis C Virus Genotype 1B|"subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks and undergo paired liver biopsies, pre-treatment and either at 2 or 4 weeks after starting therapy.
Asunaprevir and Daclatsvir"
82458|NCT01888900|E1|Reported Event|Hepatitis C Virus Genotype 1A|"Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
Asunaprevir, daclatsvir, peginterferon, ribavirin"
82459|NCT01888367|B4|Baseline|Total|Total of all reporting groups
82460|NCT01888367|B3|Baseline|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
82461|NCT01888367|B2|Baseline|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Placebo Gel"
82462|NCT01888367|B1|Baseline|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Antibiotic Gel"
82463|NCT01888367|P3|Participant Flow|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
82464|NCT01888367|P2|Participant Flow|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Placebo Gel"
82465|NCT01888367|P1|Participant Flow|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Antibiotic Gel"
82467|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Placebo Gel"
82468|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Antibiotic Gel"
82469|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
82470|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Placebo Gel"
82471|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Antibiotic Gel"
82472|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
82473|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Placebo Gel"
82474|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Antibiotic Gel"
82475|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
82476|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Placebo Gel"
82477|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Antibiotic Gel"
82478|NCT01888367|E3|Reported Event|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
82479|NCT01888367|E2|Reported Event|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Placebo Gel"
82480|NCT01888367|E1|Reported Event|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Antibiotic Gel"
82481|NCT01888003|B4|Baseline|Total|Total of all reporting groups
82482|NCT01888003|B3|Baseline|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82573|NCT01887470|B1|Baseline|Full Dose Preparation; AM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon.
82483|NCT01888003|B2|Baseline|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82484|NCT01888003|B1|Baseline|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
82485|NCT01888003|P3|Participant Flow|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82486|NCT01888003|P2|Participant Flow|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82487|NCT01888003|P1|Participant Flow|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
82488|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82489|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82490|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
82613|NCT01887418|E1|Reported Event|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week"
82491|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82492|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82493|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
82494|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82593|NCT01887418|B3|Baseline|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Delatestryl 200 mg IM Treatment C: injected once only"
83289|NCT01880723|E2|Reported Event|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
82495|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82496|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
82497|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82498|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82525|NCT01887678|B2|Baseline|Placebo Injectable Solution|At baseline, patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82614|NCT01887353|B3|Baseline|Total|Total of all reporting groups
82499|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
82500|NCT01888003|E3|Reported Event|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82501|NCT01888003|E2|Reported Event|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
82531|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82594|NCT01887418|B2|Baseline|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week for 6 weeks"
82502|NCT01888003|E1|Reported Event|Anemia Treatment Group (AMG)|"Patients diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days, −7 days before their planned surgery, and if indicated, based on labs, testing on the day of their surgery"
82503|NCT01887990|B5|Baseline|Total|Total of all reporting groups
82504|NCT01887990|B4|Baseline|Suicidal, Depression and Opioid Use With Ketamine|"suicidal and depressed,opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm
placebo"
82505|NCT01887990|B3|Baseline|Suicidal, Depression and Opioid Use With Ketamine|"suicidal and depressed, opioid use 0.2 mg/kg IV ketamine administered as a one time dose
Ketamine"
82506|NCT01887990|B2|Baseline|Suicidal, Depression With Saline|"suicidal and depressed, no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm
placebo"
82507|NCT01887990|B1|Baseline|Suicidal, Depression With Ketamine|"suicidal and depressed, no substance use 0.2 mg/kg IV ketamine administered as a one time dose
Ketamine"
82508|NCT01887990|P4|Participant Flow|Suicidal, Depression With Opioid Use With Saline|suicidal, depression with opioid use, given saline IV
82509|NCT01887990|P3|Participant Flow|Suicidal, Depression and Opioid Use With Ketamine|suicidal, depressed with opioid use, given 0.2 mg/kg ketamine one time dose IV infusion
82510|NCT01887990|P2|Participant Flow|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm
placebo"
82511|NCT01887990|P1|Participant Flow|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose in patients with suicidal ideatin and depression without substance use
Ketamine"
82512|NCT01887990|O4|Outcome|Suicidal, Opioid Use With Saline|suicidal patients who use opioids who received saline infusion or placebo
82513|NCT01887990|O3|Outcome|Suicidal, Opioid Use With Ketamine|suicidal pts who have used opioids, in the ketamine treatment arm
82514|NCT01887990|O2|Outcome|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm
placebo"
82515|NCT01887990|O1|Outcome|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose
Ketamine"
82516|NCT01887990|O4|Outcome|Suicidal, Opioid Use With Saline|Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm
82517|NCT01887990|O3|Outcome|Suicidal, Opioid Use With Ketamine|suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose
82518|NCT01887990|O2|Outcome|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm
placebo"
82519|NCT01887990|O1|Outcome|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose
Ketamine"
82520|NCT01887990|E4|Reported Event|Suicidal, Depression and Opioid With Saline|"Suicidal with depression and opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm
placebo"
82521|NCT01887990|E3|Reported Event|Suicidal, Depression and Opioid Use With Ketamine|"Suicidal with depression and opioid use 0.2 mg/kg IV ketamine administered as a one time dose
Ketamine"
82522|NCT01887990|E2|Reported Event|Suicidal, Depression With Saline|"Suicidal with depression and no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm
placebo"
82523|NCT01887990|E1|Reported Event|Suicidal, Depression With Ketamine|"Suicidal with depression and no substance use 0.2 mg/kg IV ketamine administered as a one time dose
Ketamine"
82524|NCT01887678|B3|Baseline|Total|Total of all reporting groups
82526|NCT01887678|B1|Baseline|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82527|NCT01887678|P2|Participant Flow|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82528|NCT01887678|P1|Participant Flow|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82529|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82530|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
83290|NCT01880723|E1|Reported Event|Healthy|Healthy control subjects
82532|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82533|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82534|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82535|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82536|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82537|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82538|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82539|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82540|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82541|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82542|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82543|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82544|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82545|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82546|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82547|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82548|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82549|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82550|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82551|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82552|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82553|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82554|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82555|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82556|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82557|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82558|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82559|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82560|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82561|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82562|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82563|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82564|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82565|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82566|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82567|NCT01887678|E2|Reported Event|Placebo Injectable Solution|At baseline, patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82568|NCT01887678|E1|Reported Event|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
82569|NCT01887470|B5|Baseline|Total|Total of all reporting groups
82570|NCT01887470|B4|Baseline|Split Dose Preparation; PM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
82571|NCT01887470|B3|Baseline|Split Dose Preparation; AM Colonscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.
82572|NCT01887470|B2|Baseline|Full Dose Preparation: PM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon.
82574|NCT01887470|P4|Participant Flow|Split Dose Preparation; PM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
82575|NCT01887470|P3|Participant Flow|Split Dose Preparation; AM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.
82576|NCT01887470|P2|Participant Flow|Full Dose Preparation; PM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon.
82577|NCT01887470|P1|Participant Flow|Full Dose Preparation; AM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon.
82578|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
82579|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
82580|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
82581|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
82582|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution
82583|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
82584|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
82585|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution
82586|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
82587|NCT01887470|O4|Outcome|Regimen B for PM Colonoscopy|"Regimen B for afternoon colonoscopy
Regimen B"
82588|NCT01887470|O3|Outcome|Regimen B for AM Colonoscopy|"Regimen B for morning colonoscopy
Regimen B"
82589|NCT01887470|O2|Outcome|Regimen A for PM Colonoscopy|"Regimen A for afternoon colonoscopy
Regimen A"
82590|NCT01887470|O1|Outcome|Regimen A for AM Colonoscopy|"Regimen A for morning colonoscopy
Regimen A"
82591|NCT01887470|E1|Reported Event|Lactulose for Oral Solution|All patients taking lactulose for oral solution were evaluated as one group for purposes of providing survey data on the use of the product as a bowel preparation agent for colonoscopy.
82592|NCT01887418|B4|Baseline|Total|Total of all reporting groups
82595|NCT01887418|B1|Baseline|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week for 6 weeks"
82596|NCT01887418|P3|Participant Flow|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Delatestryl 200 mg IM Treatment C: injected once only"
82597|NCT01887418|P2|Participant Flow|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week."
82598|NCT01887418|P1|Participant Flow|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week"
82599|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Delatestryl 200 mg IM Treatment C: Standard of care"
82600|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
82601|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
82602|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Delatestryl 200 mg IM Treatment C: Standard of care"
82603|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
82604|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
82605|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Delatestryl 200 mg IM Treatment C: Standard of care"
82606|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
82607|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
82608|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Delatestryl 200 mg IM Treatment C: Standard of care"
82609|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
82610|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
82611|NCT01887418|E3|Reported Event|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Delatestryl 200 mg IM Treatment C: injected once only"
82612|NCT01887418|E2|Reported Event|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use
QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week."
82615|NCT01887353|B2|Baseline|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
82616|NCT01887353|B1|Baseline|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
82617|NCT01887353|P2|Participant Flow|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
82618|NCT01887353|P1|Participant Flow|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
82619|NCT01887353|O2|Outcome|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
82620|NCT01887353|O1|Outcome|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
82621|NCT01887353|E2|Reported Event|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
82622|NCT01887353|E1|Reported Event|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
82623|NCT01887171|B3|Baseline|Total|Total of all reporting groups
82624|NCT01887171|B2|Baseline|HTK Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
82625|NCT01887171|B1|Baseline|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.
Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
82626|NCT01887171|P2|Participant Flow|HTK Solution Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
82661|NCT01886807|E2|Reported Event|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
82662|NCT01886807|E1|Reported Event|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
82663|NCT01886781|B3|Baseline|Total|Total of all reporting groups
82664|NCT01886781|B2|Baseline|Placebo|Controls Crytalline cellulose powder
82665|NCT01886781|B1|Baseline|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
82666|NCT01886781|P2|Participant Flow|Placebo|Controls Crytalline cellulose powder
82627|NCT01887171|P1|Participant Flow|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.
Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
82628|NCT01887171|O2|Outcome|HTK Solution Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
82629|NCT01887171|O1|Outcome|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.
Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
82630|NCT01887171|E2|Reported Event|HTK Solution|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
82631|NCT01887171|E1|Reported Event|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.
Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
82632|NCT01886963|B3|Baseline|Total|Total of all reporting groups
82633|NCT01886963|B2|Baseline|SPY - Unblinded Use of SPY Elite|"Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.
VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
82644|NCT01886937|P2|Participant Flow|Placebo (for Phentermine 37.5mg) First, Followed by Phentermin|"In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days.
placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration."
82877|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82634|NCT01886963|B1|Baseline|Control - Blinded Use of SPY Elite|"Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.
Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
82635|NCT01886963|P2|Participant Flow|Control - Blinded Use of SPY Elite|"Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.
Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
82636|NCT01886963|P1|Participant Flow|SPY - Unblinded Use of SPY Elite|"SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.
SPY - Unblinded Use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
82637|NCT01886963|O2|Outcome|Group B|"Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.
VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
82638|NCT01886963|O1|Outcome|Group A|"Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.
Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
82639|NCT01886963|E2|Reported Event|Control - Blinded Use of SPY Elite|"Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventra l hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.
Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
82640|NCT01886963|E1|Reported Event|SPY - Unblinded Use of SPY Elite|"SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.
SPY - Unblinded use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
82641|NCT01886937|B3|Baseline|Total|Total of all reporting groups
82642|NCT01886937|B2|Baseline|Placebo First, Then 37.5mg Phentermine|"In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days.
placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration."
82643|NCT01886937|B1|Baseline|37.5 mg Phentermine First, Then Placebo|"In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo.
Other names for phentermine:
adipex ionamin
Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo."
82878|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82645|NCT01886937|P1|Participant Flow|37.5 mg Phentermine Daily for 7 Days First,Followed by Placebo|"In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo.
Other names for phentermine:
adipex ionamin
Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo."
82646|NCT01886937|O2|Outcome|Placebo (for Phentermine 37.5mg)|"In this arm, participants receive Placebo (for 37.5mg phentermine) for 7 days.
placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration."
82647|NCT01886937|O1|Outcome|37.5 mg Phentermine Daily for 7 Days|"In this arm, participants receive 37.5mg phentermine for one week .
Other names for phentermine:
adipex ionamin
Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo."
82648|NCT01886937|E2|Reported Event|Placebo|This group refers to all participants who received Placebo.
82649|NCT01886937|E1|Reported Event|37.5 mg Phentermine|"This describes all participants who received 37.5mg phentermine for one week.
Other names for phentermine:
adipex ionamin"
82650|NCT01886807|B4|Baseline|Total|Total of all reporting groups
82651|NCT01886807|B3|Baseline|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
82652|NCT01886807|B2|Baseline|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
82653|NCT01886807|B1|Baseline|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
82654|NCT01886807|P3|Participant Flow|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
82655|NCT01886807|P2|Participant Flow|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
82656|NCT01886807|P1|Participant Flow|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
82657|NCT01886807|O3|Outcome|(VL Group)|"nasotracheal intubation using the Truview PCD video laryngoscope
TrueView PCD Video Laryngoscope"
82658|NCT01886807|O2|Outcome|(DL-O2 Group)|"direct laryngoscopy for nasotracheal intubation with oxygen insufflation
TrueView PCD Video Laryngoscope"
82659|NCT01886807|O1|Outcome|(DL Group)|"direct laryngoscopy for nasotracheal intubation without oxygen insufflation
TrueView PCD Video Laryngoscope"
82660|NCT01886807|E3|Reported Event|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
82673|NCT01886716|B4|Baseline|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.
Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
82674|NCT01886716|B3|Baseline|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.
Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.
Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
82675|NCT01886716|B2|Baseline|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.
Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
82676|NCT01886716|B1|Baseline|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.
Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
82677|NCT01886716|P4|Participant Flow|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.
Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
82678|NCT01886716|P3|Participant Flow|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.
Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.
Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
82679|NCT01886716|P2|Participant Flow|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.
Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
82680|NCT01886716|P1|Participant Flow|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.
Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
82681|NCT01886716|O4|Outcome|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.
Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
82714|NCT01886313|P1|Participant Flow|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
Civamide Nasal Spray"
82715|NCT01886313|O2|Outcome|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Placebo"
82682|NCT01886716|O3|Outcome|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.
Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.
Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
82683|NCT01886716|O2|Outcome|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.
Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
82684|NCT01886716|O1|Outcome|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.
Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
82685|NCT01886716|O4|Outcome|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.
Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
82686|NCT01886716|O3|Outcome|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.
Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.
Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
82687|NCT01886716|O2|Outcome|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.
Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
82688|NCT01886716|O1|Outcome|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.
Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
82689|NCT01886716|E4|Reported Event|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.
Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
82690|NCT01886716|E3|Reported Event|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.
Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.
Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
82691|NCT01886716|E2|Reported Event|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.
Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
82692|NCT01886716|E1|Reported Event|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.
Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
82693|NCT01886690|B3|Baseline|Total|Total of all reporting groups
82694|NCT01886690|B2|Baseline|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
82695|NCT01886690|B1|Baseline|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
82696|NCT01886690|P2|Participant Flow|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
82697|NCT01886690|P1|Participant Flow|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
82698|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
82699|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
82700|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
82701|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
82702|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
82703|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
82704|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
82705|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
82706|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
82707|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
82708|NCT01886690|E2|Reported Event|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
82709|NCT01886690|E1|Reported Event|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
82710|NCT01886313|B3|Baseline|Total|Total of all reporting groups
82711|NCT01886313|B2|Baseline|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Placebo"
82712|NCT01886313|B1|Baseline|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
Civamide Nasal Spray"
82713|NCT01886313|P2|Participant Flow|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Placebo"
82879|NCT01884675|O2|Outcome|Ambrisentan 5mg|Subjects in this arm will receive ambrisentan-matching placebo tablet once daily during the treatment period.
82716|NCT01886313|O1|Outcome|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
Civamide Nasal Spray"
82717|NCT01886313|E2|Reported Event|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Placebo"
82718|NCT01886313|E1|Reported Event|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
Civamide Nasal Spray"
82719|NCT01886300|B1|Baseline|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
82720|NCT01886300|P1|Participant Flow|Peginterferon Alfa-2a|Participants with hepatitis B envelope antigen (HBeAg) positive chronic hepatitis B who received peginterferon alfa-2a [Pegasys] were included.
82721|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
82722|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
82723|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
82724|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
82725|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
82726|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
82727|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
82728|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
82729|NCT01886300|E1|Reported Event|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
82730|NCT01886287|B1|Baseline|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
82731|NCT01886287|P1|Participant Flow|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
82732|NCT01886287|O1|Outcome|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
82733|NCT01886287|O1|Outcome|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
82734|NCT01886287|E1|Reported Event|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
82735|NCT01886235|B1|Baseline|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Diagnostic Microscopy: Undergo intravital microscopy
Fluorescein Sodium Injection: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery"
83291|NCT01880697|B3|Baseline|Total|Total of all reporting groups
82736|NCT01886235|P1|Participant Flow|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Diagnostic Microscopy: Undergo intravital microscopy
Fluorescein Sodium Injection: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery"
82737|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Diagnostic Microscopy: Undergo intravital microscopy
Fluorescein Sodium Injection: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery"
82738|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Diagnostic Microscopy: Undergo intravital microscopy
Fluorescein Sodium Injection: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery"
82739|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Diagnostic Microscopy: Undergo intravital microscopy
Fluorescein Sodium Injection: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery"
82740|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Diagnostic Microscopy: Undergo intravital microscopy
Fluorescein Sodium Injection: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery"
82741|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Diagnostic Microscopy: Undergo intravital microscopy
Fluorescein Sodium Injection: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery"
82742|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Diagnostic Microscopy: Undergo intravital microscopy
Fluorescein Sodium Injection: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery"
82743|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Diagnostic Microscopy: Undergo intravital microscopy
Fluorescein Sodium Injection: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery"
82796|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82744|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Diagnostic Microscopy: Undergo intravital microscopy
Fluorescein Sodium Injection: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery"
82745|NCT01886235|E1|Reported Event|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Diagnostic Microscopy: Undergo intravital microscopy
Fluorescein Sodium Injection: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery"
82746|NCT01885910|B1|Baseline|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
82747|NCT01885910|P1|Participant Flow|Doxy + Aczone|"Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily
Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks."
82748|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
82749|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
82750|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
82751|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
82752|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
82753|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
82754|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
82755|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
82756|NCT01885910|O2|Outcome|Aczone/Doxy - Non Inflammatory|non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
82757|NCT01885910|O1|Outcome|Aczone/Doxy - Inflammatory|inflammatory lesion counts during treatment with aczone 5% and doxycycline 100mg
82849|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82758|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
82759|NCT01885910|E1|Reported Event|Doxy + Aczone|"Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily
Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks."
82760|NCT01885871|B1|Baseline|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
82761|NCT01885871|P1|Participant Flow|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
82762|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
82763|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
82764|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
82765|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
82766|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
82767|NCT01885871|E1|Reported Event|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
82768|NCT01885559|B3|Baseline|Total|Total of all reporting groups
82769|NCT01885559|B2|Baseline|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82770|NCT01885559|B1|Baseline|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82771|NCT01885559|P2|Participant Flow|ACE-I + Angiotensin Receptor Blocker (ARB)|"ACE-I + angiotensin receptor blocker (ARB) and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82873|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82772|NCT01885559|P1|Participant Flow|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82773|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82774|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82775|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82776|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82777|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82778|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82779|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82780|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82781|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82782|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82783|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82784|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82785|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82786|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82787|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82788|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82789|NCT01885559|E2|Reported Event|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82790|NCT01885559|E1|Reported Event|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
82791|NCT01885117|B3|Baseline|Total|Total of all reporting groups
82792|NCT01885117|B2|Baseline|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82793|NCT01885117|B1|Baseline|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82794|NCT01885117|P2|Participant Flow|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82795|NCT01885117|P1|Participant Flow|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82874|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82797|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82798|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82799|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82800|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82801|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82802|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82803|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82804|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82805|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82806|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82807|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82808|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82809|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82810|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82811|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82812|NCT01885117|E2|Reported Event|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82813|NCT01885117|E1|Reported Event|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
82814|NCT01885104|B3|Baseline|Total|Total of all reporting groups
82815|NCT01885104|B2|Baseline|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
82816|NCT01885104|B1|Baseline|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
82817|NCT01885104|P2|Participant Flow|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
82818|NCT01885104|P1|Participant Flow|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
82819|NCT01885104|O2|Outcome|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
82820|NCT01885104|O1|Outcome|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
82821|NCT01885104|O2|Outcome|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
82822|NCT01885104|O1|Outcome|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
82875|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82823|NCT01885104|E2|Reported Event|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
82824|NCT01885104|E1|Reported Event|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
82825|NCT01885000|B3|Baseline|Total|Total of all reporting groups
82826|NCT01885000|B2|Baseline|Vehicle|once-daily brimonidine tartrate vehicle gel
82827|NCT01885000|B1|Baseline|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
82828|NCT01885000|P2|Participant Flow|Vehicle|once-daily brimonidine tartrate vehicle gel
82829|NCT01885000|P1|Participant Flow|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
82830|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
82831|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
82832|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
82833|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
82834|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
82835|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
82836|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
82837|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
82838|NCT01885000|E2|Reported Event|Vehicle|once-daily brimonidine tartrate vehicle gel
82839|NCT01885000|E1|Reported Event|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
82840|NCT01884688|B1|Baseline|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion
ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
82841|NCT01884688|P1|Participant Flow|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion
ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
82842|NCT01884688|O1|Outcome|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion
ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
82843|NCT01884688|E1|Reported Event|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion
ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
82844|NCT01884675|B3|Baseline|Total|Total of all reporting groups
82845|NCT01884675|B2|Baseline|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82846|NCT01884675|B1|Baseline|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82847|NCT01884675|P2|Participant Flow|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82848|NCT01884675|P1|Participant Flow|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82851|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82852|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82853|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82854|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.c
82855|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82856|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82857|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82858|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82859|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82860|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82861|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82862|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82863|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82864|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82865|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82866|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82867|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82868|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82869|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82870|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82871|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82872|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82881|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82882|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82883|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82884|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82885|NCT01884675|E2|Reported Event|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
82886|NCT01884675|E1|Reported Event|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
82887|NCT01884571|B1|Baseline|Immunosuppression Regimen|All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
82888|NCT01884571|P1|Participant Flow|Immunosuppression Regimen|"All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment (described below) and the treatment period lasted for six months.
Basiliximab: 20 mg, IV (in the vein) on day 1 and 4.
Methylprednisolone: 125 mg, IV (in the vein) on day 1.
Prednisone: 60 mg PO (by mouth) on days 2-7, 40 mg PO days 8-14, 20 mg PO days 15-21, and 10mg PO days 22-28.
Tacrolimus: 1-5 mg PO, BID (twice a day) days 2-180.
Mycophenolate mofetil: 500 mg PO, BID days 2-7, 500 mg PO each morning and 1000 mg each night, days 8-14, 1000 mg PO BID days 15-180."
82889|NCT01884571|O1|Outcome|Immunosuppression Regimen|"Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months."
82890|NCT01884571|E1|Reported Event|Immunosuppression Regimen|All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
82891|NCT01884519|B3|Baseline|Total|Total of all reporting groups
82892|NCT01884519|B2|Baseline|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82893|NCT01884519|B1|Baseline|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82894|NCT01884519|P2|Participant Flow|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82895|NCT01884519|P1|Participant Flow|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82950|NCT01883999|E1|Reported Event|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
82951|NCT01883986|B3|Baseline|Total|Total of all reporting groups
82896|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82897|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82898|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82899|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82900|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82901|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82902|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82903|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82904|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82905|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82906|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82907|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82930|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82908|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82909|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccinationars Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82910|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82911|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82912|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82913|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82914|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82915|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82916|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82917|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82918|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82919|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82920|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82921|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82922|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82923|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82924|NCT01884519|O2|Outcome|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82925|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82926|NCT01884519|O2|Outcome|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82927|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82928|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82929|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83086|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
82931|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82932|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82933|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82934|NCT01884519|E2|Reported Event|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82935|NCT01884519|E1|Reported Event|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
82936|NCT01884064|B3|Baseline|Total|Total of all reporting groups
82937|NCT01884064|B2|Baseline|Sham rTMS|"Sham Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.
Sham rTMS: Sham rTMS"
82938|NCT01884064|B1|Baseline|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.
rTMS: rTMS"
82939|NCT01884064|P2|Participant Flow|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.
rTMS: rTMS"
82940|NCT01884064|P1|Participant Flow|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.
rTMS: rTMS"
82941|NCT01884064|O2|Outcome|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.
rTMS: rTMS"
82942|NCT01884064|O1|Outcome|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.
rTMS: rTMS"
82943|NCT01884064|E2|Reported Event|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.
rTMS: rTMS"
82944|NCT01884064|E1|Reported Event|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.
rTMS: rTMS"
82945|NCT01883999|B1|Baseline|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
82946|NCT01883999|P1|Participant Flow|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
82947|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
82948|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
82952|NCT01883986|B2|Baseline|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
82953|NCT01883986|B1|Baseline|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.
Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
82954|NCT01883986|P2|Participant Flow|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
82955|NCT01883986|P1|Participant Flow|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.
Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
82956|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
82957|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.
Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
82958|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
82992|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program"
82959|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.
Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
82960|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
82961|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.
Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
82962|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
82963|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.
Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
82964|NCT01883986|E2|Reported Event|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
82965|NCT01883986|E1|Reported Event|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.
Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
82966|NCT01883908|B3|Baseline|Total|Total of all reporting groups
82967|NCT01883908|B2|Baseline|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.
Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
82968|NCT01883908|B1|Baseline|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).
Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).
Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
82969|NCT01883908|P2|Participant Flow|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.
Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
82970|NCT01883908|P1|Participant Flow|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).
Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).
Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
82971|NCT01883908|O2|Outcome|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.
Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
82972|NCT01883908|O1|Outcome|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).
Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).
Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
82973|NCT01883908|O2|Outcome|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.
Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
82993|NCT01883635|E4|Reported Event|Dyadic Exercise Intervention - Caregivers|Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
82994|NCT01883635|E3|Reported Event|Individual Exercise Intervention - Caregivers|Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
82974|NCT01883908|O1|Outcome|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).
Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).
Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
82975|NCT01883908|E2|Reported Event|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.
Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
82976|NCT01883908|E1|Reported Event|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).
Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).
Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
82977|NCT01883895|B1|Baseline|Exercise Treatment|"Concentric exercise will utilize a dumbbell with elbow flexion exercise. Isometric exercise will consist of submaximal exercise by squeezing the hand dynamometer with dominant hand at 30% of maximum for same duration as for concentric contractions,.
Forgioni-Barber pressure-pain stimulator: Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator to deliver 3000-gm force to the middle digit of the non-dominant middle finger for up to 120 seconds. During stimulation, subjects will press a button attached to a timer when the pressure stimulus first becomes painful (pain threshold) and will also rate their perceived pain intensity using a 0-100 numeric pain rating scale at 20 second intervals during the 2 minute exposure to the pressure stimulus. This validated protocol has been used in previous research by investigators in this study."
82978|NCT01883895|P1|Participant Flow|Exercise Treatment|"Concentric exercise will utilize a dumbbell with elbow flexion exercise. Isometric exercise will consist of submaximal exercise by squeezing the hand dynamometer with dominant hand at 30% of maximum for same duration as for concentric contractions,.
Forgioni-Barber pressure-pain stimulator: Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator to deliver 3000-gm force to the middle digit of the non-dominant middle finger for up to 120 seconds. During stimulation, subjects will press a button attached to a timer when the pressure stimulus first becomes painful (pain threshold) and will also rate their perceived pain intensity using a 0-100 numeric pain rating scale at 20 second intervals during the 2 minute exposure to the pressure stimulus. This validated protocol has been used in previous research by investigators in this study."
82979|NCT01883895|O1|Outcome|Exercise Treatment|"Concentric exercise: subject will utilize a dumbbell with elbow flexion exercise.
Isometric exercise: Subjects will perform 5 sets of sustained muscle contraction.
Control: Subjects will undergo a control arm where they will rest for approximately 10 minutes.
Pain testing conducted Forgionei-Barber pressure pain stimulator"
83104|NCT01882413|P1|Participant Flow|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
82980|NCT01883895|O1|Outcome|Exercise Treatment|"Concentric exercise: subject will utilize a dumbbell with elbow flexion exercise.
Isometric exercise: Subjects will perform 5 sets of sustained muscle contraction.
Control: Subjects will undergo a control arm where they will rest for approximately 10 minutes.
Pain testing conducted Forgionei-Barber pressure pain stimulator"
82981|NCT01883895|E1|Reported Event|Exercise Treatment|"Concentric exercise: subject will utilize a dumbbell with elbow flexion exercise.
Isometric exercise: Subjects will perform 5 sets of sustained muscle contraction.
Control: Subjects will undergo a control arm where they will rest for approximately 10 minutes.
Pain testing conducted Forgionei-Barber pressure pain stimulator"
82982|NCT01883635|B3|Baseline|Total|Total of all reporting groups
82983|NCT01883635|B2|Baseline|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program"
82984|NCT01883635|B1|Baseline|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program"
82985|NCT01883635|P2|Participant Flow|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program"
82986|NCT01883635|P1|Participant Flow|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program"
82987|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program"
82988|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program"
82989|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program"
82990|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program"
82991|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program"
82995|NCT01883635|E2|Reported Event|Dyadic Exercise Intervention - Cancer Survivors|Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
82996|NCT01883635|E1|Reported Event|Individual Exercise Intervention - Cancer Survivors|Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
82997|NCT01883453|B3|Baseline|Total|Total of all reporting groups
82998|NCT01883453|B2|Baseline|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.
Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
82999|NCT01883453|B1|Baseline|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week
Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
83000|NCT01883453|P2|Participant Flow|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.
Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
83001|NCT01883453|P1|Participant Flow|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week
Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
83002|NCT01883453|O2|Outcome|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.
Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
83003|NCT01883453|O1|Outcome|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week
Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
83004|NCT01883453|E2|Reported Event|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.
Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
83005|NCT01883453|E1|Reported Event|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week
Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
83006|NCT01883440|B3|Baseline|Total|Total of all reporting groups
83007|NCT01883440|B2|Baseline|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.
Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
83008|NCT01883440|B1|Baseline|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week
saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
83009|NCT01883440|P2|Participant Flow|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.
Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
83010|NCT01883440|P1|Participant Flow|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week
saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
83011|NCT01883440|O2|Outcome|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.
Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
83012|NCT01883440|O1|Outcome|Saline+Glucose|A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week
83013|NCT01883440|O2|Outcome|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.
Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
83014|NCT01883440|O1|Outcome|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week
saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
83015|NCT01883440|E2|Reported Event|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.
Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
83016|NCT01883440|E1|Reported Event|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week
saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
83017|NCT01883427|B3|Baseline|Total|Total of all reporting groups
83018|NCT01883427|B2|Baseline|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.
Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
83019|NCT01883427|B1|Baseline|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months
Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
83020|NCT01883427|P2|Participant Flow|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.
Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
83021|NCT01883427|P1|Participant Flow|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months
Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
83022|NCT01883427|O2|Outcome|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.
Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
83023|NCT01883427|O1|Outcome|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months
Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
83024|NCT01883427|E2|Reported Event|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.
Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
83025|NCT01883427|E1|Reported Event|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months
Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
83026|NCT01882907|B3|Baseline|Total|Total of all reporting groups
83027|NCT01882907|B2|Baseline|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
83028|NCT01882907|B1|Baseline|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks"
83029|NCT01882907|P2|Participant Flow|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
83030|NCT01882907|P1|Participant Flow|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks"
83031|NCT01882907|O2|Outcome|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
83032|NCT01882907|O1|Outcome|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks"
83033|NCT01882907|E2|Reported Event|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
83034|NCT01882907|E1|Reported Event|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks"
83035|NCT01882868|B1|Baseline|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83036|NCT01882868|P1|Participant Flow|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg intravenous (IV) infusion (1-2 hours) on Day 1 of Cycle 1 and every 2 weeks (q2w) thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until disease progression (DP), unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83037|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83038|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83039|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83040|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83070|NCT01882647|B3|Baseline|Total|Total of all reporting groups
83071|NCT01882647|B2|Baseline|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
83072|NCT01882647|B1|Baseline|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
83041|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83042|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83043|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83044|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83045|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83046|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83047|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83048|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83049|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83050|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83051|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83052|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83053|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83054|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83073|NCT01882647|P2|Participant Flow|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
83074|NCT01882647|P1|Participant Flow|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
83075|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
83055|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83056|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83057|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83058|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83059|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83060|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83061|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83062|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83063|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83064|NCT01882868|E1|Reported Event|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
83065|NCT01882725|B1|Baseline|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.
Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
83066|NCT01882725|P1|Participant Flow|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.
Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
83067|NCT01882725|O1|Outcome|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.
Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
83068|NCT01882725|O1|Outcome|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.
Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
83069|NCT01882725|E1|Reported Event|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.
Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
83087|NCT01882647|E2|Reported Event|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
83088|NCT01882647|E1|Reported Event|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
83089|NCT01882465|B1|Baseline|Overall|All subjects that were enrolled into the study.
83090|NCT01882465|P7|Participant Flow|Not Assigned|Subjects that signed the inform consent, but them withdrew consent, prior to lens dispensing.
83091|NCT01882465|P6|Participant Flow|Hefilcon A/Etafilcon A /2-HEMA, EGDMA Non-ionic|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the etafilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
83092|NCT01882465|P5|Participant Flow|Hefilcon A/2-HEMA, EGDMA Non-ionic/Etafilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
83093|NCT01882465|P4|Participant Flow|2-HEMA, EGDMA Non-ionic/Hefilcon A/Etafilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
83094|NCT01882465|P3|Participant Flow|2-HEMA, EGDMA Non-ionic/Etafilcon A/Hefilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the etafilcon A lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
83095|NCT01882465|P2|Participant Flow|Etafilcon A/Hefilcon A/2-HEMA, EGDMA Non-ionic|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the hefilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
83096|NCT01882465|P1|Participant Flow|Etafilcon A/2-HEMA, EGDMA/Hefilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
83097|NCT01882465|O3|Outcome|Hefilcon A|Subjects that received the hefilcon A lens in any of the three study periods.
83098|NCT01882465|O2|Outcome|2-HEMA, EGDMA Non-ionic|Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods.
83099|NCT01882465|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in any of the three study periods.
83100|NCT01882465|E3|Reported Event|Hefilcon A|Subjects that received the hefilcon A lens in any of the three study periods.
83101|NCT01882465|E2|Reported Event|2-HEMA, EGDMA Non-ionic|Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods.
83102|NCT01882465|E1|Reported Event|Etafilcon A|Subjects that received the etafilcon A lens in any of the three study periods.
83103|NCT01882413|B1|Baseline|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83105|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83106|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83107|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83108|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83109|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83110|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83111|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83112|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83113|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83114|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83115|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83116|NCT01882413|E1|Reported Event|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
83117|NCT01882257|B4|Baseline|Total|Total of all reporting groups
83220|NCT01880840|P1|Participant Flow|Astepro 0.15%|azelastine hydrochloride 822mcg nasal spray
83221|NCT01880840|O2|Outcome|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily
137 mcg of azelastine hydrochloride: nasal spray"
83222|NCT01880840|O1|Outcome|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily
205.5 mcg of azelastine hydrochloride: nasal spray"
83118|NCT01882257|B3|Baseline|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.
BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
83119|NCT01882257|B2|Baseline|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.
BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
83120|NCT01882257|B1|Baseline|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
83121|NCT01882257|P3|Participant Flow|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.
BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
83122|NCT01882257|P2|Participant Flow|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.
BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
83123|NCT01882257|P1|Participant Flow|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
83124|NCT01882257|O1|Outcome|Entire Tested Population|All groups are considered together because in determining the efficiency and reliability of home-based overnight testing, there is no difference between the three groups
83125|NCT01882257|O1|Outcome|Entire Tested Population|All groups are considered together because this outcome is simply identifying what portion of the defined population (People with Spinal Cord Injury) have which types of sleep disordered breathing
83126|NCT01882257|E3|Reported Event|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.
BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
83203|NCT01881087|B1|Baseline|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83127|NCT01882257|E2|Reported Event|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.
BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
83128|NCT01882257|E1|Reported Event|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
83129|NCT01882062|B1|Baseline|Triheptanoin Oil at 1g/kg/Day for 1 Month|Patients received triheptanoin oil at 1g/kg/day for 1 month
83130|NCT01882062|P1|Participant Flow|Triheptanoin Oil at 1g/kg/Day for 1 Month|Patients received triheptanoin oil at 1g/kg/day for 1 month
83131|NCT01882062|O1|Outcome|Triheptanoin Oil at 1g/kg/Day for 1 Month|All the participants received triheptanoin oil at 1g/kg/day for 1 month
83132|NCT01882062|E1|Reported Event|Triheptanoin Oil at 1g/kg/Day for 1 Month|All the participants received triheptanoin oil at 1g/kg/day for 1 month
83133|NCT01881984|B1|Baseline|Ravicti|"Open Label Study
Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
83134|NCT01881984|P1|Participant Flow|Ravicti|"Open Label Study
Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
83135|NCT01881984|O1|Outcome|Ravicti|"Open Label Study
Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
83136|NCT01881984|O1|Outcome|Ravicti|"Open Label Study
Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
83137|NCT01881984|E1|Reported Event|Ravicti|"Open Label Study
Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day"
83138|NCT01881932|B4|Baseline|Total|Total of all reporting groups
83139|NCT01881932|B3|Baseline|Sham Acupuncture|"Patients stratified based on cancer (breast cancer vs colorectal cancer). The patients will be randomly assigned to get sham acupuncture until the end of their chemo while following the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels.
Sham Acupuncture using Park Sham placebo acupuncture device: Participants will get sham acupuncture until the end of chemo.
Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape next to the needles. She will tap a mock plastic needle gui"
83223|NCT01880840|E2|Reported Event|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily
137 mcg of azelastine hydrochloride: nasal spray"
83224|NCT01880840|E1|Reported Event|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily
205.5 mcg of azelastine hydrochloride: nasal spray"
83225|NCT01880736|B5|Baseline|Total|Total of all reporting groups
83140|NCT01881932|B2|Baseline|Acupuncture|Pts stratified based on cancer (breast cancer vs colorectal cancer). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. In standard care arm, patients will not get addiinl therapy for CIPN. Acupuncture using Seirin® needles: Participants will get acupuncture weekly til the end of chemo. Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points & immediately affix a pair of needles to the surface of the same points with adhesive tape, w
83141|NCT01881932|B1|Baseline|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
83142|NCT01881932|P3|Participant Flow|Sham Acupuncture|"Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will be randomly assigned to receive sham acupuncture until the end of their chemotherapy while following the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels.
Sham Acupuncture using Park Sham placebo acupuncture device: Participants will receive sham acupuncture until the end of chemotherapy.
Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape"
83143|NCT01881932|P2|Participant Flow|Acupuncture|"Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). Patients will be randomly assigned to receive acupuncture until the end of their chemotherapy. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not receive additional therapy for CIPN.
Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.
Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points, and"
83204|NCT01881087|P3|Participant Flow|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83144|NCT01881932|P1|Participant Flow|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
83145|NCT01881932|O3|Outcome|Sham Acupuncture|Patients stratified based on cancer (breast vs colorectal). Patients to get sham acupuncture til the end of their chemo & following the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. Pt complete a wkly questionnaire to determine severity of nerve pain symptoms. Each wk record the total amount of chemo in the past week & all together. Each wk patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device of a retractable needle & an adhesive tube into sham points &apply 2 pieces of adhesive tape next to needles; will tap a mock plastic needle guiding tube on surface of each of 8 true points in the arm & leg to produce some discernible sensation & then apply needle w/ piece of adhesive tape to dermal surface, w/out needle insertion.
83146|NCT01881932|O2|Outcome|Acupuncture|Patients stratified based on cancer (breast cancer vs colorectal cancer). The patients will be randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week & all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. In standard care arm, patients will not get additional therapy for CIPN. Acupuncture using Seirin® needles: Participants will get acupuncture weekly until the end of chemotherapy. Subjects will get acupuncture at documented acupoints. To improve blinding effect, acupuncturist will also tap 2 guiding tubes at 2 sham points & immediately affix a pair of needles to surface of the same points with adhesive tape, no needle insertion.
83147|NCT01881932|O1|Outcome|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
83187|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.
Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.
If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
83148|NCT01881932|E3|Reported Event|Sham Acupuncture|Patients stratified based on cancer (breast vs colorectal). The patients get sham acupuncture til the end of chemo with same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient complete a weekly questionnaire to determine severity of nerve pain symptoms. Weekly record total amount of chemo received in the past week & all together. Each week patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle & adhesive tube into the sham points, & then apply 2 pieces of adhesive tape next to needles. Will tap mock plastic needle guiding tube on the surface of each of 8 true points in arm & leg to produce sensation & apply a needle with piece of adhesive tape to dermal surface, no needle insertion.
83149|NCT01881932|E2|Reported Event|Acupuncture|"Patients stratified based on cancer (breast vs colorectal). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not get additional therapy for CIPN.
Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.
Subjects will get acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will tap 2 guiding tubes at 2 sham points & affix a pair of needles to the surface of the same points with adhesive tape, without needle insertion."
83150|NCT01881932|E1|Reported Event|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
83151|NCT01881776|B4|Baseline|Total|Total of all reporting groups
83152|NCT01881776|B3|Baseline|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
83153|NCT01881776|B2|Baseline|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83154|NCT01881776|B1|Baseline|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83155|NCT01881776|P3|Participant Flow|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
83156|NCT01881776|P2|Participant Flow|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83157|NCT01881776|P1|Participant Flow|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83158|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
83159|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83188|NCT01881737|O1|Outcome|Pregnenolone|"Pregnenolone up to 500 mg per day
Pregnenolone: With Baseline serving as approximately day 1, twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.
Week 1 and 2: 100 mg
Week 3 and 4: 200 mg
Week 5 and 6: 300 mg
Week 7 and 8: 400 mg
Week 9 -12: 500 mg
At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.
If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
83160|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83161|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
83162|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83163|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83164|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
83165|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83205|NCT01881087|P2|Participant Flow|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83166|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83167|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
83168|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83169|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83170|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
83171|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83172|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83173|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
83189|NCT01881737|O1|Outcome|Pregnenolone|Open-Label study
84321|NCT01877278|P1|Participant Flow|Active|"emitting group
Wearable pulsed electromagnetic fields"
83174|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83175|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83176|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
83177|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83178|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83179|NCT01881776|E3|Reported Event|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
83180|NCT01881776|E2|Reported Event|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83181|NCT01881776|E1|Reported Event|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
83182|NCT01881737|B1|Baseline|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.
Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.
If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
83183|NCT01881737|P1|Participant Flow|Pregnenolone|Open-Label Trial
83184|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.
Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.
If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
83185|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.
Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.
If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
83186|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.
Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.
If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
83217|NCT01880840|B2|Baseline|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily
137 mcg of azelastine hydrochloride: nasal spray"
83218|NCT01880840|B1|Baseline|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily
205.5 mcg of azelastine hydrochloride: nasal spray"
83219|NCT01880840|P2|Participant Flow|Astepro 0.1%|azelastine hydrochloride 548 mcg nasal spray
83190|NCT01881737|E1|Reported Event|Pregnenolone|Pregnenolone was not associated with any severe adverse effects. Single episodes of tiredness (n = 1), diarrhea (n = 1), and depressive affect (n = 1) that could possibly be related to pregnenolone were reported. A few other adverse events with remote chance to be related to the medication were reported: increased excitement/agitation (n = 3), sleep problems (n = 1), drowsiness (n = 1), anorexia/decreased appetite (n = 2), increased motor activity (n = 1), sweating (n = 1), constipation (n = 1), diarrhea (n = 1), tremor (n = 1), and depressive affect (n = 1). No significant vital sign or EKG changes occurred in any study participants. No abnormal laboratory tests were caused by pregnenolone.
83191|NCT01881126|B3|Baseline|Total|Total of all reporting groups
83192|NCT01881126|B2|Baseline|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
83193|NCT01881126|B1|Baseline|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
83194|NCT01881126|P2|Participant Flow|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
83195|NCT01881126|P1|Participant Flow|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
83196|NCT01881126|O2|Outcome|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
83197|NCT01881126|O1|Outcome|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
83198|NCT01881126|E2|Reported Event|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
83199|NCT01881126|E1|Reported Event|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
83200|NCT01881087|B4|Baseline|Total|Total of all reporting groups
83201|NCT01881087|B3|Baseline|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83202|NCT01881087|B2|Baseline|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83378|NCT01880424|E1|Reported Event|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83206|NCT01881087|P1|Participant Flow|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83207|NCT01881087|O3|Outcome|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83208|NCT01881087|O2|Outcome|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83209|NCT01881087|O1|Outcome|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83210|NCT01881087|O3|Outcome|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83211|NCT01881087|O2|Outcome|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83212|NCT01881087|O1|Outcome|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83213|NCT01881087|E3|Reported Event|Levo-11.25|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83214|NCT01881087|E2|Reported Event|Levo-9.37|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83215|NCT01881087|E1|Reported Event|Levo-7.5 mg|"Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s."
83216|NCT01880840|B3|Baseline|Total|Total of all reporting groups
83226|NCT01880736|B4|Baseline|IDeg OD Flexible Dosing and Stepwise Titration (Arm D)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
83227|NCT01880736|B3|Baseline|IDeg OD Flexible Dosing and Simple Titration (Arm C)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
83228|NCT01880736|B2|Baseline|IDeg OD Fixed Dosing and Stepwise Titration (Arm B)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
83229|NCT01880736|B1|Baseline|IDeg OD Fixed Dosing and Simple Titration (Arm A)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
83230|NCT01880736|P4|Participant Flow|IDeg OD Flexible Dosing and Stepwise Titration (Arm D)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
83231|NCT01880736|P3|Participant Flow|IDeg OD Flexible Dosing and Simple Titration (Arm C)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
83232|NCT01880736|P2|Participant Flow|IDeg OD Fixed Dosing and Stepwise Titration (Arm B)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
83233|NCT01880736|P1|Participant Flow|IDeg OD Fixed Dosing and Simple Titration (Arm A)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
83234|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83379|NCT01880320|B4|Baseline|Total|Total of all reporting groups
83380|NCT01880320|B3|Baseline|Topical Gel Vehicle|"Placebo arm
Topical Gel Vehicle"
83235|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83236|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83237|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
83238|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83249|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
83239|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83240|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83241|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
83242|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83243|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83381|NCT01880320|B2|Baseline|CD0271 0.1% / CD1579 2.5%|"Comparator arm
CD0271 0.1% / CD1579 2.5%"
83244|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83245|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
83246|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83247|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83248|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83304|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83250|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83251|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83252|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83253|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
83263|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83254|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83255|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83256|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83257|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
83258|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83269|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
83259|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83260|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83261|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
83262|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83282|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
83264|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83265|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
83266|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83267|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83268|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83303|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83270|NCT01880736|E4|Reported Event|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83271|NCT01880736|E3|Reported Event|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83272|NCT01880736|E2|Reported Event|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
83273|NCT01880736|E1|Reported Event|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
83274|NCT01880723|B3|Baseline|Total|Total of all reporting groups
83275|NCT01880723|B2|Baseline|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
83276|NCT01880723|B1|Baseline|Healthy|Healthy Control subjects
83277|NCT01880723|P2|Participant Flow|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
83278|NCT01880723|P1|Participant Flow|Healthy|Healthy control subjects
83279|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
83280|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
83281|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
83292|NCT01880697|B2|Baseline|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83293|NCT01880697|B1|Baseline|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83294|NCT01880697|P2|Participant Flow|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83295|NCT01880697|P1|Participant Flow|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83296|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83297|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83298|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83299|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83300|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83301|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83302|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
84322|NCT01877278|O2|Outcome|Placebo|"non emitting device
Wearable pulsed electromagnetic fields"
83305|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83306|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83307|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83308|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83309|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83310|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83311|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83312|NCT01880697|E2|Reported Event|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83313|NCT01880697|E1|Reported Event|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
83314|NCT01880515|B3|Baseline|Total|Total of all reporting groups
83315|NCT01880515|B2|Baseline|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
83316|NCT01880515|B1|Baseline|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations
Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
83317|NCT01880515|P2|Participant Flow|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
83318|NCT01880515|P1|Participant Flow|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)
Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 (afatinib)"
83319|NCT01880515|O2|Outcome|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
83320|NCT01880515|O1|Outcome|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)
Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 whereas the non-intervention group will recieve general dermatological recomendations while on treatment with BIBW2992."
83321|NCT01880515|O2|Outcome|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
83322|NCT01880515|O1|Outcome|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)
Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
83382|NCT01880320|B1|Baseline|CD0271 0.3% /CD1579 2.5% Gel|"Active arm
CD0271 0.3% / CD1579 2.5%"
83323|NCT01880515|E2|Reported Event|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
83324|NCT01880515|E1|Reported Event|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)
Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
83325|NCT01880437|B4|Baseline|Total|Total of all reporting groups
83326|NCT01880437|B3|Baseline|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83327|NCT01880437|B2|Baseline|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83328|NCT01880437|B1|Baseline|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83329|NCT01880437|P3|Participant Flow|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83330|NCT01880437|P2|Participant Flow|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83474|NCT01879722|P3|Participant Flow|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83331|NCT01880437|P1|Participant Flow|Poor Risk Cytogenetics|Participants with relapsed/refractory acute myeloid leukemia (AML) or relapsed/refractory high-risk myelodysplastic syndrome (MDS) falling under 'poor risk cytogenetics' subgroup received oral 150 milligrams (mg) dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83332|NCT01880437|O1|Outcome|Planned Cohort 2|Participants in Cohort 2 were planned to receive low-dose subcutaneous injections of cytarabine in combination with continuous daily vismodegib (150 mg orally).
83333|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83334|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83335|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83336|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83337|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83338|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83339|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83340|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83341|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83383|NCT01880320|P3|Participant Flow|Topical Gel Vehicle|"Placebo arm
Topical Gel Vehicle"
83384|NCT01880320|P2|Participant Flow|CD0271 0.1% / CD1579 2.5%|"Comparator arm
CD0271 0.1% / CD1579 2.5%"
83385|NCT01880320|P1|Participant Flow|CD0271 0.3% /CD1579 2.5% Gel|"Active arm
CD0271 0.3% / CD1579 2.5%"
83342|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83343|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83344|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83345|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83346|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83347|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83348|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83349|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83350|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83351|NCT01880437|E3|Reported Event|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83352|NCT01880437|E2|Reported Event|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83353|NCT01880437|E1|Reported Event|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
83354|NCT01880424|B3|Baseline|Total|Total of all reporting groups
83355|NCT01880424|B2|Baseline|Placebo Arm|matching placebo capsules, oral, once daily
83356|NCT01880424|B1|Baseline|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83357|NCT01880424|P2|Participant Flow|Placebo Arm|matching placebo capsules, oral, once daily
83358|NCT01880424|P1|Participant Flow|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83359|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
83360|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83361|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
83362|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83363|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
83364|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83365|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
83366|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83367|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
83368|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83369|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
83370|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83371|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
83372|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83373|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
83374|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83375|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
83376|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
83377|NCT01880424|E2|Reported Event|Placebo Arm|matching placebo capsules, oral, once daily
83386|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm
Topical Gel Vehicle"
83387|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm
CD0271 0.1% / CD1579 2.5%"
83388|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm
CD0271 0.3% / CD1579 2.5%"
83389|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm
Topical Gel Vehicle"
83390|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm
CD0271 0.1% / CD1579 2.5%"
83391|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm
CD0271 0.3% / CD1579 2.5%"
83392|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm
Topical Gel Vehicle"
83393|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm
CD0271 0.1% / CD1579 2.5%"
83394|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm
CD0271 0.3% / CD1579 2.5%"
83395|NCT01880320|E3|Reported Event|Topical Gel Vehicle|"Placebo arm
Topical Gel Vehicle"
83396|NCT01880320|E2|Reported Event|CD0271 0.1% / CD1579 2.5%|"Comparator arm
CD0271 0.1% / CD1579 2.5%"
83397|NCT01880320|E1|Reported Event|CD0271 0.3% /CD1579 2.5% Gel|"Active arm
CD0271 0.3% / CD1579 2.5%"
83398|NCT01880086|B3|Baseline|Total|Total of all reporting groups
83399|NCT01880086|B2|Baseline|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.
Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
83400|NCT01880086|B1|Baseline|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.
Clomiphene citrate"
83401|NCT01880086|P2|Participant Flow|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.
Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
83402|NCT01880086|P1|Participant Flow|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.
Clomiphene citrate"
83403|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.
Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
83404|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.
Clomiphene citrate"
83405|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.
Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
83406|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.
Clomiphene citrate"
83407|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.
Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
83408|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.
Clomiphene citrate"
83409|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.
Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
83410|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.
Clomiphene citrate"
83438|NCT01879800|P1|Participant Flow|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
83411|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.
Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
83412|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.
Clomiphene citrate"
83413|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.
Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
83414|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.
Clomiphene citrate"
83415|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.
Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
83479|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83416|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.
Clomiphene citrate"
83417|NCT01880086|E2|Reported Event|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.
Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
83418|NCT01880086|E1|Reported Event|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.
Clomiphene citrate"
83419|NCT01879852|B3|Baseline|Total|Total of all reporting groups
83420|NCT01879852|B2|Baseline|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.
Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83421|NCT01879852|B1|Baseline|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83422|NCT01879852|P2|Participant Flow|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.
Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83423|NCT01879852|P1|Participant Flow|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83424|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.
Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
84975|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
83425|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83426|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.
Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83427|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83428|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.
Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83475|NCT01879722|P2|Participant Flow|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
84323|NCT01877278|O1|Outcome|Active|"emitting group
Wearable pulsed electromagnetic fields"
83429|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83430|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.
Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83431|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83432|NCT01879852|E2|Reported Event|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.
Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83433|NCT01879852|E1|Reported Event|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.
Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
83434|NCT01879800|B3|Baseline|Total|Total of all reporting groups
83435|NCT01879800|B2|Baseline|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .
Acceptance and Commitment Therapy plus Illness Management"
83436|NCT01879800|B1|Baseline|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
83437|NCT01879800|P2|Participant Flow|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .
Acceptance and Commitment Therapy plus Illness Management"
83439|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .
Acceptance and Commitment Therapy plus Illness Management"
83440|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
83441|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .
Acceptance and Commitment Therapy plus Illness Management"
83442|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
83476|NCT01879722|P1|Participant Flow|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83477|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83478|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83443|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .
Acceptance and Commitment Therapy plus Illness Management"
83444|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
83445|NCT01879800|E2|Reported Event|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .
Acceptance and Commitment Therapy plus Illness Management"
83446|NCT01879800|E1|Reported Event|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
83447|NCT01879735|B3|Baseline|Total|Total of all reporting groups
83448|NCT01879735|B2|Baseline|Bolus vs. Constant Infusion|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
83449|NCT01879735|B1|Baseline|ICG's Effect on 11C-CSar Transport|Examine the effect of indocyanine green (ICG) on the rate constants for the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
83450|NCT01879735|P2|Participant Flow|Bolus and Constant Infusion of 11C-CSar|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
83451|NCT01879735|P1|Participant Flow|ICG Infusion|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
83452|NCT01879735|O2|Outcome|Infusion Method|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
83453|NCT01879735|O1|Outcome|ICG Infusion|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
83454|NCT01879735|E2|Reported Event|Bolus vs. Constant Infusion|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
83455|NCT01879735|E1|Reported Event|ICG's Effect on 11C-CSar Transport|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
83456|NCT01879722|B11|Baseline|Total|Total of all reporting groups
83457|NCT01879722|B10|Baseline|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
83458|NCT01879722|B9|Baseline|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83459|NCT01879722|B8|Baseline|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
84976|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
83460|NCT01879722|B7|Baseline|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83461|NCT01879722|B6|Baseline|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83462|NCT01879722|B5|Baseline|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83463|NCT01879722|B4|Baseline|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83464|NCT01879722|B3|Baseline|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83465|NCT01879722|B2|Baseline|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83466|NCT01879722|B1|Baseline|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia
83467|NCT01879722|P10|Participant Flow|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
83468|NCT01879722|P9|Participant Flow|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83469|NCT01879722|P8|Participant Flow|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83470|NCT01879722|P7|Participant Flow|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83471|NCT01879722|P6|Participant Flow|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83472|NCT01879722|P5|Participant Flow|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83473|NCT01879722|P4|Participant Flow|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83480|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83481|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83482|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83483|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83484|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83485|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83486|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83487|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83488|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83489|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83490|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83491|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83492|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83493|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83494|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83495|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83496|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83497|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83498|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83499|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83500|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83501|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83502|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83503|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83504|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83505|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83506|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83507|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83508|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83509|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83510|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83511|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83512|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83513|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83514|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83515|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83516|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83517|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83518|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83519|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83520|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83521|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83522|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
84324|NCT01877278|O2|Outcome|Placebo|"non emitting device
Wearable pulsed electromagnetic fields"
83523|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83524|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83525|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83526|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83527|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83528|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83529|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83530|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83531|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83532|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83533|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83534|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83535|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83536|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83537|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83538|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83539|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83540|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83541|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83542|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83543|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83544|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83545|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83546|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83547|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83548|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83549|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83550|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83551|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83552|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83553|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83554|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83555|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83556|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83557|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83558|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83559|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83560|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83561|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83562|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83563|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83564|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83565|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
84325|NCT01877278|O1|Outcome|Active|"emitting group
Wearable pulsed electromagnetic fields"
83566|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83567|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83568|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83569|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83570|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83571|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83572|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83573|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
83574|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83575|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83576|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83577|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83578|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83579|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83580|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83581|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83582|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83583|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
83584|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83585|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83586|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83587|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83588|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83589|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83590|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83591|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83592|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83593|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
83594|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83595|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83596|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83597|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83598|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83599|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83600|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83601|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83602|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83603|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
83604|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83605|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83606|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83607|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83608|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83609|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83610|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83611|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83612|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83613|NCT01879722|E10|Reported Event|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
83614|NCT01879722|E9|Reported Event|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83615|NCT01879722|E8|Reported Event|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83616|NCT01879722|E7|Reported Event|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
83617|NCT01879722|E6|Reported Event|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83618|NCT01879722|E5|Reported Event|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83619|NCT01879722|E4|Reported Event|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83620|NCT01879722|E3|Reported Event|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83621|NCT01879722|E2|Reported Event|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83622|NCT01879722|E1|Reported Event|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
83623|NCT01879683|B1|Baseline|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
83624|NCT01879683|P1|Participant Flow|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
83625|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
83626|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
83627|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
83628|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
83629|NCT01879683|E1|Reported Event|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
83630|NCT01879618|B1|Baseline|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
83631|NCT01879618|P1|Participant Flow|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
84977|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
83632|NCT01879618|O1|Outcome|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
83633|NCT01879618|O1|Outcome|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
83634|NCT01879618|E1|Reported Event|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
83635|NCT01879579|B3|Baseline|Total|Total of all reporting groups
83636|NCT01879579|B2|Baseline|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83637|NCT01879579|B1|Baseline|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83638|NCT01879579|P2|Participant Flow|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83639|NCT01879579|P1|Participant Flow|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83640|NCT01879579|O1|Outcome|All Participants|Participants in both study arms (MITI and CBP).
83641|NCT01879579|O1|Outcome|All Participants|Participants in both study arms (MITI and CBP).
83642|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83643|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83644|NCT01879579|O2|Outcome|Insulin Titration Visits in the Clinic|Insulin titration visits that occurred in the clinic in both study arms (MITI and CBP arms).
83645|NCT01879579|O1|Outcome|Insulin Titration Visits by Phone|Insulin titration visits that occurred over the phone in both study arms (MITI and CBP arms).
83646|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83647|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83648|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83649|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83650|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83667|NCT01879553|B2|Baseline|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83668|NCT01879553|B1|Baseline|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83651|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83652|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83653|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83654|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83655|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83656|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83918|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging
Targeted messaging: 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter"
83657|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83658|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83659|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83660|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83661|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83662|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83663|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83664|NCT01879579|E2|Reported Event|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
83665|NCT01879579|E1|Reported Event|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.
Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
83666|NCT01879553|B3|Baseline|Total|Total of all reporting groups
83701|NCT01879410|B3|Baseline|Total|Total of all reporting groups
83669|NCT01879553|P2|Participant Flow|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83670|NCT01879553|P1|Participant Flow|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83671|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83672|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83673|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83674|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83675|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83676|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83677|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83678|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83679|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83680|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83681|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83682|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83683|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83684|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83685|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83686|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83687|NCT01879553|E3|Reported Event|Total|Total
83688|NCT01879553|E2|Reported Event|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83689|NCT01879553|E1|Reported Event|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
83690|NCT01879540|B1|Baseline|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
83691|NCT01879540|P1|Participant Flow|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
83692|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
83693|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
83694|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
83695|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
83696|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
83697|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
83698|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
83699|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
83700|NCT01879540|E1|Reported Event|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
83702|NCT01879410|B2|Baseline|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
83703|NCT01879410|B1|Baseline|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
83704|NCT01879410|P2|Participant Flow|FSC 250/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 250/50 µg twice daily (BID) in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
83705|NCT01879410|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg)) once daily (QD) in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI for 12 weeks.
83706|NCT01879410|O2|Outcome|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
83707|NCT01879410|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
83708|NCT01879410|O2|Outcome|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
83709|NCT01879410|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
83710|NCT01879410|E2|Reported Event|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
83711|NCT01879410|E1|Reported Event|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
83712|NCT01879371|B7|Baseline|Total|Total of all reporting groups
83728|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83713|NCT01879371|B6|Baseline|Ibu Lysinate / Ibu Acid / Ibu + Caf|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83714|NCT01879371|B5|Baseline|Ibu Lysinate/ Ibu + Caf / Ibu Acid|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83715|NCT01879371|B4|Baseline|Ibu Acid/ Ibu + Caf / Ibu Lysinate|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83716|NCT01879371|B3|Baseline|Ibu Acid / Ibu Lysinate/ Ibu + Caf|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83717|NCT01879371|B2|Baseline|Ibu + Caf / Ibu Lysinate / Ibu Acid|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83718|NCT01879371|B1|Baseline|Ibu + Caf / Ibu Acid / Ibu Lysinate|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83719|NCT01879371|P6|Participant Flow|Ibu Lysinate / Ibu Acid / Ibu + Caf|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83720|NCT01879371|P5|Participant Flow|Ibu Lysinate/ Ibu + Caf / Ibu Acid|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83754|NCT01879345|E2|Reported Event|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
83755|NCT01879345|E1|Reported Event|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
83756|NCT01879332|B4|Baseline|Total|Total of all reporting groups
83721|NCT01879371|P4|Participant Flow|Ibu Acid/ Ibu + Caf / Ibu Lysinate|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83722|NCT01879371|P3|Participant Flow|Ibu Acid / Ibu Lysinate/ Ibu + Caf|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83723|NCT01879371|P2|Participant Flow|Ibu + Caf / Ibu Lysinate / Ibu Acid|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83724|NCT01879371|P1|Participant Flow|Ibu + Caf / Ibu Acid / Ibu Lysinate|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
83725|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83726|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83727|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83729|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83730|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83731|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83732|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83733|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83734|NCT01879371|E3|Reported Event|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83735|NCT01879371|E2|Reported Event|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83736|NCT01879371|E1|Reported Event|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
83737|NCT01879345|B4|Baseline|Total|Total of all reporting groups
83738|NCT01879345|B3|Baseline|Placebo|PLC, Placebo
83739|NCT01879345|B2|Baseline|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
83740|NCT01879345|B1|Baseline|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
83741|NCT01879345|P3|Participant Flow|Placebo|PLC, Placebo
83742|NCT01879345|P2|Participant Flow|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
83743|NCT01879345|P1|Participant Flow|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
83744|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
83745|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
83746|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
83747|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
83748|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|4 tablets of BIA 2-093 600 mg BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg Oxcarbazepine is a BIA 2-093 metabolite
83749|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|3 tablets of BIA 2-093 600 mg BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093 Oxcarbazepine is a BIA 2-093 metabolite
83750|NCT01879345|O3|Outcome|Placebo|PLC, Placebo
83751|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
83752|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
83753|NCT01879345|E3|Reported Event|Placebo|PLC, Placebo
83757|NCT01879332|B3|Baseline|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
83758|NCT01879332|B2|Baseline|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
83759|NCT01879332|B1|Baseline|Placebo|"Matching placebo tablets for oral administration
Placebo: Matching placebo tablets for oral administration"
83760|NCT01879332|P3|Participant Flow|Placebo|"Matching placebo tablets for oral administration
Placebo: Matching placebo tablets for oral administration"
83761|NCT01879332|P2|Participant Flow|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
83762|NCT01879332|P1|Participant Flow|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
83763|NCT01879332|O3|Outcome|Placebo|"Matching placebo tablets for oral administration
Placebo: Matching placebo tablets for oral administration"
83764|NCT01879332|O2|Outcome|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
83765|NCT01879332|O1|Outcome|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
83766|NCT01879332|E3|Reported Event|Placebo|"Matching placebo tablets for oral administration
Placebo: Matching placebo tablets for oral administration"
83767|NCT01879332|E2|Reported Event|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
83768|NCT01879332|E1|Reported Event|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
83769|NCT01879319|B3|Baseline|Total|Total of all reporting groups
83770|NCT01879319|B2|Baseline|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
83771|NCT01879319|B1|Baseline|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
83772|NCT01879319|P2|Participant Flow|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
83773|NCT01879319|P1|Participant Flow|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
83774|NCT01879319|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
83775|NCT01879319|O1|Outcome|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
83776|NCT01879319|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
83777|NCT01879319|O1|Outcome|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
83778|NCT01879319|E2|Reported Event|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
83779|NCT01879319|E1|Reported Event|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
83780|NCT01879176|B3|Baseline|Total|Total of all reporting groups
83781|NCT01879176|B2|Baseline|Control|No filter will be installed on the CPB machine.
83782|NCT01879176|B1|Baseline|CytoSorb|For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1.
83783|NCT01879176|P2|Participant Flow|Control|No filter will be installed on the CPB machine.
83784|NCT01879176|P1|Participant Flow|CytoSorb|"For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .
CytoSorb"
83785|NCT01879176|O2|Outcome|Control|No filter will be installed on the CPB machine.
83786|NCT01879176|O1|Outcome|CytoSorb|For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .
83787|NCT01879176|E2|Reported Event|Control|No filter will be installed on the CPB machine.
83788|NCT01879176|E1|Reported Event|CytoSorb|"For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .
CytoSorb"
83789|NCT01879059|B1|Baseline|Exercise|"5 days of inactivity followed by a 1 day return to physical activity
Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
83790|NCT01879059|P1|Participant Flow|Exercise|"5 days of inactivity followed by a 1 day return to physical activity
Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
83791|NCT01879059|O1|Outcome|Exercise|"5 days of inactivity followed by a 1 day return to physical activity
Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
83792|NCT01879059|E1|Reported Event|Exercise|"5 days of inactivity followed by a 1 day return to physical activity
Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
83793|NCT01878825|B3|Baseline|Total|Total of all reporting groups
83794|NCT01878825|B2|Baseline|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83795|NCT01878825|B1|Baseline|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
83796|NCT01878825|P2|Participant Flow|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83797|NCT01878825|P1|Participant Flow|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
83798|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83799|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83800|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83801|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83802|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83803|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83804|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83805|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83806|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83807|NCT01878825|O3|Outcome|Fluviral >60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83808|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83809|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83810|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83811|NCT01878825|O3|Outcome|Fluviral > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83812|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83813|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83814|NCT01878825|O4|Outcome|Fluviral >60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83815|NCT01878825|O3|Outcome|Fluviral > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83816|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83817|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83818|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83819|NCT01878825|O3|Outcome|Fluviral >60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83820|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83821|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
83822|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83823|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
83824|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83825|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
83916|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging
Targeted messaging: 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter"
83826|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83827|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
83828|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83829|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
83830|NCT01878825|E2|Reported Event|Fluarix/Influsplit › 60 Years Group|Subjects aged › 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
83831|NCT01878825|E1|Reported Event|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
83832|NCT01878812|B3|Baseline|Total|Total of all reporting groups
83833|NCT01878812|B2|Baseline|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83834|NCT01878812|B1|Baseline|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83835|NCT01878812|P2|Participant Flow|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83836|NCT01878812|P1|Participant Flow|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83837|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83838|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83839|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83840|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83841|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83842|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83843|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83844|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83845|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83846|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
84028|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
83847|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83848|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83849|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83850|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83851|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83852|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83853|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83854|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83855|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83856|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83857|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83917|NCT01878214|O2|Outcome|Control Group|"Standard messaging
Standard messaging: 1 informational letter"
83858|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83859|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83860|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83861|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83862|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83863|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83864|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83865|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83866|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83867|NCT01878812|E2|Reported Event|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83868|NCT01878812|E1|Reported Event|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
83869|NCT01878799|B3|Baseline|Total|Total of all reporting groups
83870|NCT01878799|B2|Baseline|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
83871|NCT01878799|B1|Baseline|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
83872|NCT01878799|P2|Participant Flow|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
83873|NCT01878799|P1|Participant Flow|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
83874|NCT01878799|O2|Outcome|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
83875|NCT01878799|O1|Outcome|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
83876|NCT01878799|E2|Reported Event|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
83877|NCT01878799|E1|Reported Event|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
83878|NCT01878656|B3|Baseline|Total|Total of all reporting groups
83879|NCT01878656|B2|Baseline|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
83880|NCT01878656|B1|Baseline|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
83881|NCT01878656|P2|Participant Flow|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
83882|NCT01878656|P1|Participant Flow|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
83919|NCT01878214|O2|Outcome|Control Group|"Standard messaging
Standard messaging: 1 informational letter"
83883|NCT01878656|O2|Outcome|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
83884|NCT01878656|O1|Outcome|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
83885|NCT01878656|E2|Reported Event|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
83886|NCT01878656|E1|Reported Event|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
83887|NCT01878604|B1|Baseline|Patients of HoFH|patients of Homozygous Familial Hypercholesterolemia
83888|NCT01878604|P1|Participant Flow|Homozygous Familial Hypercholesterolemia|"Gene Analysis for Homozygous Familial Hypercholesterolemia cases
Gene analysis: Gene analysis"
83889|NCT01878604|O1|Outcome|HoFH Patients|"patients of Homozygous Familial Hypercholesterolemia that meet the Inclusion criteria:
Cutaneous xanthomata before the age of ten years
LDLC > 13 mmol/L before treatment or > 7.76 mmol/L despite treatment
Phenotypic features in keeping with HeFH in both parents"
83890|NCT01878604|O1|Outcome|HoFH Patients|HoFH patients
83891|NCT01878604|E1|Reported Event|HoFH Patients|all HoFH patients enrolled in this study
83892|NCT01878526|B3|Baseline|Total|Total of all reporting groups
83893|NCT01878526|B2|Baseline|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
83894|NCT01878526|B1|Baseline|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
83895|NCT01878526|P2|Participant Flow|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
83896|NCT01878526|P1|Participant Flow|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
83897|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
83898|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
83899|NCT01878526|O1|Outcome|Overall Systemic Sclerosis With GERD (Before Randomization)|omeprazole 20 mg bid ac for 4 weeks for overall systemic sclerosis with GERD
83900|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
83901|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
83902|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
83903|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
83904|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
83905|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
83906|NCT01878526|E2|Reported Event|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
83907|NCT01878526|E1|Reported Event|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
83908|NCT01878214|B3|Baseline|Total|Total of all reporting groups
83909|NCT01878214|B2|Baseline|Control Group|"Standard messaging
Standard messaging: 1 informational letter"
83910|NCT01878214|B1|Baseline|Intervention Group|"Targeted messaging
Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter"
83911|NCT01878214|P2|Participant Flow|Control Group|"Standard messaging
Standard messaging: 1 informational letter"
83912|NCT01878214|P1|Participant Flow|Intervention Group|"Targeted messaging
Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter"
83913|NCT01878214|O2|Outcome|Control Group|"Standard messaging
Standard messaging: 1 informational letter"
83914|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging
Targeted messaging: 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter"
83915|NCT01878214|O2|Outcome|Control Group|"Standard messaging
Standard messaging: 1 informational letter"
83920|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging
Targeted messaging: 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter"
83921|NCT01878214|O2|Outcome|Control Group|"Standard messaging
Standard messaging: 1 informational letter"
83922|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging
Targeted messaging: 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter"
83923|NCT01878214|E2|Reported Event|Control Group|"Standard messaging
Standard messaging: 1 informational letter"
83924|NCT01878214|E1|Reported Event|Intervention Group|"Targeted messaging
Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter"
83925|NCT01878175|B1|Baseline|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83926|NCT01878175|P1|Participant Flow|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at VA medical center, in-home with clinical personnel, and via telephone. Intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program focuses on lower extremity mobility, muscle stability and functional movement patterns. Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week.
83927|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83928|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83929|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83969|NCT01877941|E1|Reported Event|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored during surgery and during post-surgical recovery. For instance, patients with ischemic heart disease undergoing cardiac bypass graft or percutaneous coronary intervention.
No adverse events."
83970|NCT01877720|B1|Baseline|Total Enrolled Patients|
84299|NCT01876329|O1|Outcome|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
83930|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83931|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83932|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83933|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
84001|NCT01877668|P5|Participant Flow|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
83934|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83935|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83936|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83937|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83938|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83939|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83940|NCT01878175|O1|Outcome|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83941|NCT01878175|E1|Reported Event|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
83942|NCT01878149|B3|Baseline|Total|Total of all reporting groups
83943|NCT01878149|B2|Baseline|eXtreme Lumbar Interbody Fusion (XLIF®)|This study included adult men and women (> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the XLIF® spinal procedure. XLIF® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
83944|NCT01878149|B1|Baseline|VEO® Lateral Access and Interbody Fusion System|This study included adult men and women (> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the VEO® spinal procedure. VEO® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
83945|NCT01878149|P2|Participant Flow|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc.When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
83946|NCT01878149|P1|Participant Flow|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the Baxano Surgical LLIF system, which employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. The VEO® system was developed with an initial, radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. Dissection through the psoas is then performed with direct vision in conjunction with EMG. The psoas muscle is split anterior-posterior along muscle fiber lines and the retraction is performed with two independent blades. Insertion depth may be varied to avoid muscle creep, and the toed-out blade tips are positioned under the psoas to hold the system in place. An inner sleeve is inserted to lock the blades in place at the desired radial tension for a customizable disc space exposure. Standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
83947|NCT01878149|O2|Outcome|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
83948|NCT01878149|O1|Outcome|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
83949|NCT01878149|E2|Reported Event|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
83971|NCT01877720|P2|Participant Flow|NAVA-PS|"noninvasive NAVA first for 15 minutes and then PSV for 15 minutes
crossover of noninvasive respiratory support with NAVA mode and PSV"
83972|NCT01877720|P1|Participant Flow|PS-NAVA|"noninvasive PSV first for 15 minutes and then NAVA for 15 minutes
crossover of noninvasive respiratory support with NAVA mode and PSV"
83973|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
83950|NCT01878149|E1|Reported Event|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO® Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
83951|NCT01878097|B3|Baseline|Total|Total of all reporting groups
83952|NCT01878097|B2|Baseline|Control Training|
83953|NCT01878097|B1|Baseline|Green Dot Bystander Training|"26 high schools: 13 receiving Green Dot intervention and 13 no intervention
Green Dot Bystander Intevention: Intervention allocated at the school level"
83954|NCT01878097|P2|Participant Flow|Control|13 high school receiving no bystander training (no intervention)
83955|NCT01878097|P1|Participant Flow|Green Dot Bystander Training|"13 receiving Green Dot intervention
Green Dot Bystander Intevention: Intervention allocated at the school level"
83956|NCT01878097|O2|Outcome|Control|No bystander intervention
83957|NCT01878097|O1|Outcome|Green Dot Bystander Training|Phase one and two.
83958|NCT01878097|O2|Outcome|Control|No bystander intervention
83959|NCT01878097|O1|Outcome|Green Dot Bystander Training|Phase one and two.
83960|NCT01878097|O2|Outcome|Control|No bystander intervention
83961|NCT01878097|O1|Outcome|Green Dot Bystander Training|Phase one and two.
83962|NCT01878097|E2|Reported Event|Control|In 13 Kentucky region , 2 demographically comparable high schools were recruited to participate in GreenDot intervention as either the intervention or control site. Schools were randomly assigned to the intervention. Control schools received no additional programming on their campus.
83963|NCT01878097|E1|Reported Event|GreenDot|"Experimental: GreenDot Bystander Training GreenDot is a bystander intervention program that empowers students to actively question peer support for sexual violence (SV) and become change agents who play a significant role in preventing sexual violence."
83964|NCT01877941|B1|Baseline|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).
Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.
Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
84034|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
83965|NCT01877941|P1|Participant Flow|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).
Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.
Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
83966|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).
Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.
Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
83967|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).
Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.
Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.
Estimated Continuous Cardiac Output (esCCO): Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body."
83968|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).
Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.
Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.
Estimated Continuous Cardiac Output (esCCO): Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body."
83974|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
83975|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
83976|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
83996|NCT01877668|B5|Baseline|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
83997|NCT01877668|B4|Baseline|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
83998|NCT01877668|B3|Baseline|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
83999|NCT01877668|B2|Baseline|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84000|NCT01877668|B1|Baseline|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84326|NCT01877278|E2|Reported Event|Placebo|"non emitting device
Wearable pulsed electromagnetic fields"
84002|NCT01877668|P4|Participant Flow|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84003|NCT01877668|P3|Participant Flow|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84004|NCT01877668|P2|Participant Flow|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84005|NCT01877668|P1|Participant Flow|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84006|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84007|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84008|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84009|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84010|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84011|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84012|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84013|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84014|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84015|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84016|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84017|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84018|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84019|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84020|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84021|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84022|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84023|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84024|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84025|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84026|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84027|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84029|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84030|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84031|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84032|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84033|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84035|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84036|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84037|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84038|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84039|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84040|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84041|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84042|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84043|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84044|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84045|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84046|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84047|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84048|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84049|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84050|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84051|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84052|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84053|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84054|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84055|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84056|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84057|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84058|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84059|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84060|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84061|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84062|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84063|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84064|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84065|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84066|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84130|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84067|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84068|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84069|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84070|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84071|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84072|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84073|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84074|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84075|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84076|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84077|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84078|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84079|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84080|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84081|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84082|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84083|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84084|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84085|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84086|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84087|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84088|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84089|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84090|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84091|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84092|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84093|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84094|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84095|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84096|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84097|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84131|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84098|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84099|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84100|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84101|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84102|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84103|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84104|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84105|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84106|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84107|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84108|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84109|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84110|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84111|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84112|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84113|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84114|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84115|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84116|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84117|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84118|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84119|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84120|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84121|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84122|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84123|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84124|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84125|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84126|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84127|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84128|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84129|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84132|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84133|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84134|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84135|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84136|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84137|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84138|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84139|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84140|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84141|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84142|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84143|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84144|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84145|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84146|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84147|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84148|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84149|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84150|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84151|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84152|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84153|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84154|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84155|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84156|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84157|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84227|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84158|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84159|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84160|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84161|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84162|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84163|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84164|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84165|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84166|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84167|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84168|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84169|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84170|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84171|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84172|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84173|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84174|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84175|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84176|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84177|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84178|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84179|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84180|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84181|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84182|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84183|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84184|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84185|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84186|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84187|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84188|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84189|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84190|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84191|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84192|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84193|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84298|NCT01876329|O2|Outcome|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
84194|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84195|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84196|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84197|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84198|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84199|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84200|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84201|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84202|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84203|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84204|NCT01877668|O6|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84205|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84206|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84207|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84208|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84209|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84210|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84211|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84212|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84213|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84214|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84215|NCT01877668|O5|Outcome|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84216|NCT01877668|O4|Outcome|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84217|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84218|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84219|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84220|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84221|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84222|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84223|NCT01877668|O1|Outcome|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84224|NCT01877668|O4|Outcome|Placebo|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
84225|NCT01877668|O3|Outcome|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84226|NCT01877668|O2|Outcome|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84978|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
84228|NCT01877668|E5|Reported Event|Placebo/Tofacitinib, 10 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks
84229|NCT01877668|E4|Reported Event|Placebo/Tofacitinib, 5 mg, Twice Daily|Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
84230|NCT01877668|E3|Reported Event|Adalimumab, 40 mg, Every 2 Weeks|Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
84231|NCT01877668|E2|Reported Event|Tofacitinib, 10 mg, Twice Daily|Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
84232|NCT01877668|E1|Reported Event|Tofacitinib, 5 mg, Twice Daily|Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
84262|NCT01876368|P1|Participant Flow|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84263|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84233|NCT01877538|B1|Baseline|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical used with Positron Emission Tomography (PET) imaging. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system
[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil
7 healthy control subjects were recruited to this study."
84234|NCT01877538|P1|Participant Flow|[11C]Donepezil|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system
[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil
7 healthy control subjects were scanned in this preliminary pilot study."
84235|NCT01877538|O1|Outcome|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system
[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil"
84236|NCT01877538|O1|Outcome|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system
[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil"
84237|NCT01877538|E1|Reported Event|[11C]Donepezil|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system
[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil
7 healthy controls were PET scanned in this preliminary study.
No adverse events were detected."
84238|NCT01877408|B3|Baseline|Total|Total of all reporting groups
84239|NCT01877408|B2|Baseline|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
84240|NCT01877408|B1|Baseline|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
84241|NCT01877408|P2|Participant Flow|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
84242|NCT01877408|P1|Participant Flow|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
84243|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
84244|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
84245|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
84246|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
84247|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
84248|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
84249|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
84250|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
84251|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
84252|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
84253|NCT01877408|O1|Outcome|Physicians|The generalist doctors in this study were moderately experienced in open surgical circumcision but had not previously used the Unicirc instruments.
84254|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
84255|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
84256|NCT01877408|E2|Reported Event|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
84257|NCT01877408|E1|Reported Event|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
84258|NCT01876368|B3|Baseline|Total|Total of all reporting groups
84259|NCT01876368|B2|Baseline|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84260|NCT01876368|B1|Baseline|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84261|NCT01876368|P2|Participant Flow|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84264|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84265|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84266|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84267|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84268|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84269|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84270|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84271|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84272|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84273|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84274|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84275|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84276|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84277|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84278|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84279|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84280|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84281|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84282|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84283|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84284|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84285|NCT01876368|E2|Reported Event|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
84286|NCT01876368|E1|Reported Event|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
84287|NCT01876329|B4|Baseline|Total|Total of all reporting groups
84288|NCT01876329|B3|Baseline|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
84289|NCT01876329|B2|Baseline|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
84290|NCT01876329|B1|Baseline|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
84291|NCT01876329|P3|Participant Flow|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
84292|NCT01876329|P2|Participant Flow|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
84293|NCT01876329|P1|Participant Flow|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
84294|NCT01876329|O3|Outcome|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
84295|NCT01876329|O2|Outcome|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
84296|NCT01876329|O1|Outcome|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
84297|NCT01876329|O3|Outcome|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
84300|NCT01876329|E3|Reported Event|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
84301|NCT01876329|E2|Reported Event|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
84302|NCT01876329|E1|Reported Event|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
84303|NCT01877343|B4|Baseline|Total|Total of all reporting groups
84304|NCT01877343|B3|Baseline|Pediatric Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84320|NCT01877278|P2|Participant Flow|Placebo|"non emitting device
Wearable pulsed electromagnetic fields"
84305|NCT01877343|B2|Baseline|Pediatric Heart Transplant (1b)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84306|NCT01877343|B1|Baseline|Adult Heart Transplant (1a)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84307|NCT01877343|P7|Participant Flow|Adult Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84308|NCT01877343|P6|Participant Flow|Pediatric Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84309|NCT01877343|P5|Participant Flow|Pediatric Fontan|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84310|NCT01877343|P4|Participant Flow|Adult Fontan|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84311|NCT01877343|P3|Participant Flow|Adult Heart Failure|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84312|NCT01877343|P2|Participant Flow|Pediatric Heart Tansplant (1b)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84313|NCT01877343|P1|Participant Flow|Adult Heart Transplant (1a)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84314|NCT01877343|O1|Outcome|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84371|NCT01876979|O2|Outcome|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.
Erich Arch Bars: Surgical braces wired around teeth"
84315|NCT01877343|O1|Outcome|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84316|NCT01877343|E1|Reported Event|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
84317|NCT01877278|B3|Baseline|Total|Total of all reporting groups
84318|NCT01877278|B2|Baseline|Placebo|"non emitting device
Wearable pulsed electromagnetic fields"
84319|NCT01877278|B1|Baseline|Active|"emitting group
Wearable pulsed electromagnetic fields"
84327|NCT01877278|E1|Reported Event|Active|"emitting group
Wearable pulsed electromagnetic fields"
84328|NCT01877161|B1|Baseline|rTMS Over MTG, STG, Sham|"3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants.
3 sessions of rTMS were determined by a random sequence (eg. MTG-STG-Sham, Sham-MTG-STG, STG-MTG-Sham etc.) MTG: middle temporal gyrus STG: superior temporal gyrus
The sequence of stimulation was counter-balanced across subjects. different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions."
84329|NCT01877161|P1|Participant Flow|rTMS Over MTG, STG, Sham|"3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants 3 sessions of rTMS were determined by a random sequence (eg. middle temporal gyrus (MTG)-superior temporal gyrus (STG)-Sham, Sham-MTG-STG, STG-MTG-Sham etc..0) The sequence of stimulation was counter-balanced across subjects.
different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions."
84330|NCT01877161|O3|Outcome|Sham rTMS|The coil was placed perpendicularly to the scalp during sham rTMS sessions.
84331|NCT01877161|O2|Outcome|rTMS Over STG|Repetitive magnetic stimulation (rTMS) were applied over STG
84332|NCT01877161|O1|Outcome|rTMS Over MTG|Repetitive magnetic stimulation (rTMS) were applied over MTG
84333|NCT01877161|E3|Reported Event|Superior Temporal Gyrus|"Repetitive magnetic stimulation to superior temporal gyrus
Repetitive magnetic stimulation to superior temporal gyrus: Repetitive magnetic stimulation to superior temporal gyrus"
84334|NCT01877161|E2|Reported Event|Control Group|"Repetitive magnetic stimulation (Sham)
Repetitive magnetic stimulation (Sham): Repetitive magnetic stimulation (Sham)"
84335|NCT01877161|E1|Reported Event|Middle Temporal Gyrus|"Repetitive magnetic stimulation to middle temporal gyrus
Repetitive magnetic stimulation to middle temporal gyrus: Repetitive magnetic stimulation to middle temporal gyrus"
84336|NCT01877148|B3|Baseline|Total|Total of all reporting groups
84337|NCT01877148|B2|Baseline|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84338|NCT01877148|B1|Baseline|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84339|NCT01877148|P2|Participant Flow|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84340|NCT01877148|P1|Participant Flow|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84341|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84342|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84372|NCT01876979|O1|Outcome|IMF Screws|"Use of IMF screws as a means to wire the jaws.
IMF Screws: stainless steel screws placed in bone"
84343|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84344|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84358|NCT01876992|O2|Outcome|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.
There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
84460|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
84345|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84346|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84347|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84348|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84349|NCT01877148|E2|Reported Event|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84350|NCT01877148|E1|Reported Event|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy"
84351|NCT01876992|B3|Baseline|Total|Total of all reporting groups
84352|NCT01876992|B2|Baseline|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.
There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
84353|NCT01876992|B1|Baseline|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.
For children <50kg:
Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm
, Week 8:500mg po bid.
For children ≥50kg:
Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.
For adults:
Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.
Metformin"
84354|NCT01876992|P2|Participant Flow|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.
There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
84373|NCT01876979|E2|Reported Event|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.
Erich Arch Bars: Surgical braces wired around teeth"
84374|NCT01876979|E1|Reported Event|IMF Screws|"Use of IMF screws as a means to wire the jaws.
IMF Screws: stainless steel screws placed in bone"
84375|NCT01876823|B1|Baseline|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84355|NCT01876992|P1|Participant Flow|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.
For children <50kg:
Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm, Week 8:500mg po bid.
For children ≥50kg:
Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.
For adults:
Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.
Metformin"
84356|NCT01876992|O2|Outcome|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.
There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
84357|NCT01876992|O1|Outcome|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.
For children <50kg:
Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po AM/250mg po PM, Week 8:500mg po bid.
For children ≥50kg:
Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po AM/500mg po PM, Week 8:1000mg po bid.
For adults:
Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po AM/500mg po PM,Week 8:1000mg po bid.
Metformin"
84383|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84384|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84359|NCT01876992|O1|Outcome|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.
For children <50kg:
Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm
, Week 8:500mg po bid.
For children ≥50kg:
Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.
For adults:
Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.
Metformin"
84360|NCT01876992|O2|Outcome|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.
There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
84361|NCT01876992|O1|Outcome|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.
For children <50kg:
Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po am/250mg po pm
, Week 8:500mg po bid.
For children ≥50kg:
Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po am/500mg po pm, Week 8:1000mg po bid.
For adults:
Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po am/500mg po pm,Week 8:1000mg po bid.
Metformin"
84362|NCT01876992|O2|Outcome|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.
There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
84363|NCT01876992|O1|Outcome|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.
For children <50kg:
Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po AM/250mg po PM, Week 8:500mg po bid.
For children ≥50kg:
Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po AM/500mg po PM, Week 8:1000mg po bid.
For adults:
Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po AM/500mg po PM,Week 8:1000mg po bid.
Metformin"
84364|NCT01876992|E2|Reported Event|Obese Controls|"Three obese but otherwise healthy adult participants will be recruited into the study as controls. These will be individuals who are not currently (or previously) on any diabetic medication including metformin.
There will be a single study visit and no medication will be administered. They will be administered a meal and pre and post-prandial blood samples will be drawn."
84365|NCT01876992|E1|Reported Event|Metformin|"Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.
For children <50kg:
Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po AM/250mg po PM, Week 8:500mg po bid.
For children ≥50kg:
Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po AM/500mg po PM, Week 8:1000mg po bid.
For adults:
Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po AM/500mg po PM,Week 8:1000mg po bid.
Metformin"
84366|NCT01876979|B3|Baseline|Total|Total of all reporting groups
84367|NCT01876979|B2|Baseline|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.
Erich Arch Bars: Surgical braces wired around teeth"
84368|NCT01876979|B1|Baseline|Intermaxillary Fixation Screws|"Use of Intermaxillary Fixation screws as a means to wire the jaws.
IMF Screws: stainless steel screws placed in bone"
84369|NCT01876979|P2|Participant Flow|Erich Arch Bars|"Use of Erich Arch bars in the wiring of the jaws.
Erich Arch Bars: Surgical braces wired around teeth"
84370|NCT01876979|P1|Participant Flow|IMF Screws|"Use of IMF screws as a means to wire the jaws.
IMF Screws: stainless steel screws placed in bone"
84979|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
84376|NCT01876823|P1|Participant Flow|Es-citalopram and Memantine Treatment|This group received concurrent es-citalopram plus memantine treatment for 48 weeks. Patients ranged in age from 50-90 years old. Es-citalopram treatment began at 10mg per day for two weeks and was increased to 20mg per day for the 48 week duration. If a patient had an inadequate response to the antidepressant on two consecutive visits, the study physician used an alternative. At two weeks into the study, the patients were started on memantine 5mg, and the maximum dose of 20mg was reached by the six week point.
84377|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84378|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84379|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84380|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84381|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84382|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84385|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84386|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84387|NCT01876823|E1|Reported Event|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
84388|NCT01876810|B1|Baseline|All Study Participants|"600 mg of gemfibrozil (one capsule) twice daily for two weeks.
Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks. or One lactose pill twice a day for two weeks."
84389|NCT01876810|P2|Participant Flow|Placebo/Gemfibrozil|Participants received 1 capsule of placebo for 2 weeks. Then a washout period of 1 week of no medication. Then they received 600 mg of gemfibrozil (one capsule) twice daily for two weeks.
84390|NCT01876810|P1|Participant Flow|Gemfibrozil/Placebo|Participants received 600 mg of gemfibrozil (one capsule) twice daily for two weeks. Then a washout period of 1 week of no medication. Then they received 1 capsule of placebo twice daily for 2 weeks
84391|NCT01876810|O2|Outcome|Placebo Group|Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
84392|NCT01876810|O1|Outcome|Gemfibrozil|Participants taking Gemfibrozil 600 mg (one capsule twice daily) for two weeks during the 1st phase of the study or during the second phase after the washout period.
84393|NCT01876810|O2|Outcome|Placebo Group|Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
84394|NCT01876810|O1|Outcome|Gemfibrozil|Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
84395|NCT01876810|O2|Outcome|Placebo|Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after a washout period.
84396|NCT01876810|O1|Outcome|Gemfibrozil|Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after a washout period .
84397|NCT01876810|E2|Reported Event|Placebo/Gemfibrozil|"One lactose pill twice a day for two weeks.
Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study followed by a the washout period. Then they received 1 capsule of gemfibrozil twice daily for 2 weeks"
84398|NCT01876810|E1|Reported Event|Gemfibrozil/Placebo|"600 mg of gemfibrozil (one capsule) twice daily for two weeks.
Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study followed by a the washout period. Then they received 1 capsule of placebo twice daily for 2 weeks"
84399|NCT01876784|B3|Baseline|Total|Total of all reporting groups
84400|NCT01876784|B2|Baseline|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
84401|NCT01876784|B1|Baseline|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
84402|NCT01876784|P2|Participant Flow|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
84403|NCT01876784|P1|Participant Flow|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
84404|NCT01876784|O2|Outcome|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
84405|NCT01876784|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
84406|NCT01876784|E2|Reported Event|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
84407|NCT01876784|E1|Reported Event|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
84408|NCT01876732|B1|Baseline|Vitamin B12|Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
84409|NCT01876732|P1|Participant Flow|Vitamin B12|"Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment."
84445|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
84446|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
84980|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
84410|NCT01876732|O1|Outcome|Vitamin B12|"Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment."
84411|NCT01876732|O1|Outcome|Vitamin B12|"Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment."
84457|NCT01875978|P2|Participant Flow|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
84458|NCT01875978|P1|Participant Flow|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
84459|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
84412|NCT01876732|E1|Reported Event|Vitamin B12|"Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment."
84413|NCT01876706|B1|Baseline|UroLift Arm|Subjects that undergo the UroLift System procedure
84414|NCT01876706|P1|Participant Flow|UroLift Arm|Subjects that undergo the UroLift System procedure
84415|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84416|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84417|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84418|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84419|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84420|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84421|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84422|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84423|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84424|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84425|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84426|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84427|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84428|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
84429|NCT01876706|E1|Reported Event|UroLift Arm|Subjects that undergo the UroLift System procedure
84430|NCT01875991|B3|Baseline|Total|Total of all reporting groups
84431|NCT01875991|B2|Baseline|Autoinjector B / Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment.
84432|NCT01875991|B1|Baseline|Autoinjector A / Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment.
84433|NCT01875991|P2|Participant Flow|Autoinjector B / Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment.
84434|NCT01875991|P1|Participant Flow|Autoinjector A / Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment.
84435|NCT01875991|O2|Outcome|Autoinjector B Preference|Participants who preferred Autoinjector B overall
84436|NCT01875991|O1|Outcome|Autoinjector A Preference|Participants who preferred Autoinjector A overall
84437|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
84438|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
84439|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
84440|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
84441|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
84442|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
84443|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
84444|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
84447|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
84448|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
84449|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
84450|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
84451|NCT01875991|O1|Outcome|Primary Analysis Set|Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
84452|NCT01875991|E2|Reported Event|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
84453|NCT01875991|E1|Reported Event|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
84454|NCT01875978|B3|Baseline|Total|Total of all reporting groups
84455|NCT01875978|B2|Baseline|Group B:Placebo-phytosterols|Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
84456|NCT01875978|B1|Baseline|Group A:Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
84461|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
84462|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
84463|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
84464|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
84465|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
84466|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
84467|NCT01875978|E2|Reported Event|Group B: Placebo-phytosterols|placebo for 4 weeks, washout 2 weeks. then daily 1.8 g phytosterols for 4 weeks
84468|NCT01875978|E1|Reported Event|Group A: Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2 weeks, then placebo for 4 weeks
84469|NCT01875848|B3|Baseline|Total|Total of all reporting groups
84470|NCT01875848|B2|Baseline|Opioid Dose Escalation|"increase of up to 25% of current opioid dose
opioid dose escalation: up to 25% increase in patient's current opioid dose"
84471|NCT01875848|B1|Baseline|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment
buprenorphine/naloxone: partial opioid agonist"
84472|NCT01875848|P2|Participant Flow|Opioid Dose Escalation|"increase of up to 25% of current opioid dose
opioid dose escalation: up to 25% increase in patient's current opioid dose"
84473|NCT01875848|P1|Participant Flow|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment
buprenorphine/naloxone: partial opioid agonist"
84474|NCT01875848|O2|Outcome|Opioid Dose Escalation|"increase of up to 25% of current opioid dose
opioid dose escalation: up to 25% increase in patient's current opioid dose"
84475|NCT01875848|O1|Outcome|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment
buprenorphine/naloxone: partial opioid agonist"
84476|NCT01875848|O2|Outcome|Opioid Dose Escalation|"increase of up to 25% of current opioid dose
opioid dose escalation: up to 25% increase in patient's current opioid dose"
84477|NCT01875848|O1|Outcome|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment
buprenorphine/naloxone: partial opioid agonist"
84478|NCT01875848|E2|Reported Event|Opioid Dose Escalation|"increase of up to 25% of current opioid dose
opioid dose escalation: up to 25% increase in patient's current opioid dose"
84479|NCT01875848|E1|Reported Event|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment
buprenorphine/naloxone: partial opioid agonist"
84480|NCT01875731|B3|Baseline|Total|Total of all reporting groups
84481|NCT01875731|B2|Baseline|Guideline|"Strategy based on enforced guideline guided antibiotic use
Guideline: Strategy based on enforced guideline guided antibiotic use"
84482|NCT01875731|B1|Baseline|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use
BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
84483|NCT01875731|P2|Participant Flow|Guideline|"Strategy based on enforced guideline guided antibiotic use
Guideline: Strategy based on enforced guideline guided antibiotic use"
84484|NCT01875731|P1|Participant Flow|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use
BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
84485|NCT01875731|O2|Outcome|Guideline|"Strategy based on enforced guideline guided antibiotic use
Guideline: Strategy based on enforced guideline guided antibiotic use"
84486|NCT01875731|O1|Outcome|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use
BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
84487|NCT01875731|O2|Outcome|Guideline|"Strategy based on enforced guideline guided antibiotic use
Guideline: Strategy based on enforced guideline guided antibiotic use"
84488|NCT01875731|O1|Outcome|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use
BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
84489|NCT01875731|E2|Reported Event|Guideline|"Strategy based on enforced guideline guided antibiotic use
Guideline: Strategy based on enforced guideline guided antibiotic use"
84490|NCT01875731|E1|Reported Event|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use
BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
84491|NCT01875510|B3|Baseline|Total|Total of all reporting groups
84492|NCT01875510|B2|Baseline|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
84493|NCT01875510|B1|Baseline|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
84494|NCT01875510|P2|Participant Flow|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
84495|NCT01875510|P1|Participant Flow|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
84496|NCT01875510|O2|Outcome|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
84497|NCT01875510|O1|Outcome|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
84498|NCT01875510|E2|Reported Event|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
84499|NCT01875510|E1|Reported Event|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
84500|NCT01875471|B3|Baseline|Total|Total of all reporting groups
84501|NCT01875471|B2|Baseline|Narafilcon A|"Spherical daily disposable soft contact lens Class 1 UV blocking
narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily"
84502|NCT01875471|B1|Baseline|Delefilcon A|"Spherical daily disposable soft contact lens
delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily"
84503|NCT01875471|P2|Participant Flow|Narafilcon A|Spherical daily disposable soft contact lens with UV blocking
84504|NCT01875471|P1|Participant Flow|Delefilcon A|Spherical daily disposable soft contact lens
84505|NCT01875471|O2|Outcome|Narafilcon A|Spherical daily disposable soft contact lens with UV blocking
84506|NCT01875471|O1|Outcome|Delefilcon A|Spherical daily disposable soft contact lens
84507|NCT01875471|E2|Reported Event|Narafilcon A|"Spherical daily disposable soft contact lens Class 1 UV blocking
narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily"
84508|NCT01875471|E1|Reported Event|Delefilcon A|"Spherical daily disposable soft contact lens
delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily"
84509|NCT01875445|B3|Baseline|Total|Total of all reporting groups
84510|NCT01875445|B2|Baseline|Inositol|"Powder form, 2g TID up to 6g TID
Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
84511|NCT01875445|B1|Baseline|Placebo|"Matched dosage of inositol daily.
Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
84512|NCT01875445|P2|Participant Flow|Inositol|"Powder form, 2g TID up to 6g TID
Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
84513|NCT01875445|P1|Participant Flow|Placebo|"Matched dosage of inositol daily.
Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
84514|NCT01875445|O2|Outcome|Inositol|"Powder form, 2g TID up to 6g TID
Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
84515|NCT01875445|O1|Outcome|Placebo|"Matched dosage of inositol daily.
Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
84516|NCT01875445|O2|Outcome|Inositol|"Powder form, 2g TID up to 6g TID
Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
84517|NCT01875445|O1|Outcome|Placebo|"Matched dosage of inositol daily.
Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
84518|NCT01875445|E2|Reported Event|Inositol|"Powder form, 2g TID up to 6g TID
Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
84519|NCT01875445|E1|Reported Event|Placebo|"Matched dosage of inositol daily.
Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
84520|NCT01875159|B3|Baseline|Total|Total of all reporting groups
84521|NCT01875159|B2|Baseline|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
84522|NCT01875159|B1|Baseline|Caffeine|"Caffeine citrate 6 mg/kg/day
Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
84523|NCT01875159|P2|Participant Flow|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
84524|NCT01875159|P1|Participant Flow|Caffeine|"Caffeine citrate 6 mg/kg/day
Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
84525|NCT01875159|O2|Outcome|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
84526|NCT01875159|O1|Outcome|Caffeine|"Caffeine citrate 6 mg/kg/day
Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
84527|NCT01875159|O2|Outcome|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
84528|NCT01875159|O1|Outcome|Caffeine|"Caffeine citrate 6 mg/kg/day
Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
84529|NCT01875159|E2|Reported Event|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
84530|NCT01875159|E1|Reported Event|Caffeine|"Caffeine citrate 6 mg/kg/day
Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
84531|NCT01874951|B3|Baseline|Total|Total of all reporting groups
84532|NCT01874951|B2|Baseline|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
84533|NCT01874951|B1|Baseline|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
84534|NCT01874951|P2|Participant Flow|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
84535|NCT01874951|P1|Participant Flow|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
84578|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84536|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
84537|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
84538|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive low dose naltrexone for three weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
84539|NCT01874951|O1|Outcome|Placebo|"In this arm, patients will receive placebo for three weeks.
Placebo: Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo."
84540|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks.1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
84541|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
84542|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
84543|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
84544|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
84545|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
84546|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
84547|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
84548|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
84549|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
84550|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
84551|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
84552|NCT01874951|E2|Reported Event|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
84553|NCT01874951|E1|Reported Event|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
84554|NCT01874665|B3|Baseline|Total|Total of all reporting groups
84555|NCT01874665|B2|Baseline|Cohort B|"Patients with GIST that lack KIT exon 11 mutations (Cohort B)
ponatinib: 45 mg, taken orally once-daily"
84556|NCT01874665|B1|Baseline|Cohort A|"Patients with KIT exon 11-mutant GIST
ponatinib: 45 mg, taken orally once-daily"
84557|NCT01874665|P2|Participant Flow|Cohort B|"Patients with GIST that lack KIT exon 11 mutations (Cohort B)
ponatinib: 45 mg, taken orally once-daily"
84558|NCT01874665|P1|Participant Flow|Cohort A|"Patients with KIT exon 11-mutant GIST
ponatinib: 45 mg, taken orally once-daily"
84559|NCT01874665|O1|Outcome|Cohort B|"Patients with GIST that lack KIT exon 11 mutations (Cohort B)
ponatinib: 45 mg, taken orally once-daily"
84560|NCT01874665|O1|Outcome|Cohort A|"Patients with KIT exon 11-mutant GIST
ponatinib: 45 mg, taken orally once-daily"
84561|NCT01874665|E1|Reported Event|Cohorts A & B|All patients with GIST (with and without) KIT exon 11 mutations
84562|NCT01874340|B5|Baseline|Total|Total of all reporting groups
84563|NCT01874340|B4|Baseline|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84564|NCT01874340|B3|Baseline|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84565|NCT01874340|B2|Baseline|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84566|NCT01874340|B1|Baseline|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84686|NCT01873989|P2|Participant Flow|Waitlist Control|"This arm involves watchful waiting.
Waitlist control"
84567|NCT01874340|P4|Participant Flow|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84568|NCT01874340|P3|Participant Flow|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84569|NCT01874340|P2|Participant Flow|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84570|NCT01874340|P1|Participant Flow|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84571|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84572|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84573|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84574|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84575|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84576|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84577|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84579|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84580|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84581|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84582|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84583|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84584|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84585|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84586|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84587|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84588|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84589|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84590|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84591|NCT01874340|E4|Reported Event|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84592|NCT01874340|E3|Reported Event|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84593|NCT01874340|E2|Reported Event|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84594|NCT01874340|E1|Reported Event|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
84595|NCT01874275|B3|Baseline|Total|Total of all reporting groups
84596|NCT01874275|B2|Baseline|Device Sham|placebo treatment - no nerve stimulator treatment twice daily for 180 days of study
84597|NCT01874275|B1|Baseline|VECTTOR - Active|nerve stimulator treatment twice daily for duration of study - 365 days ...
84598|NCT01874275|P2|Participant Flow|Device - Sham|"placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by active treatment for the duration of study, 365 days
VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.
Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
84599|NCT01874275|P1|Participant Flow|VECTTOR|"muscle stimulator treatment twice daily for duration of study - 365 days
VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.
Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
84600|NCT01874275|O1|Outcome|VECTTOR|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant's muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 365 days.
84601|NCT01874275|O1|Outcome|VECTTOR|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 365 days. Efficacy is defined as an increase in range of motion.
84965|NCT01871402|B2|Baseline|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
84602|NCT01874275|O2|Outcome|Device - Sham|"placebo treatment - no electrical stimulation treatment twice daily for 180 days
VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.
Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
84603|NCT01874275|O1|Outcome|VECTTOR|"nerve stimulator treatment twice daily for duration of study - 180 days
VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.
Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
84604|NCT01874275|O2|Outcome|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by muscle stimulator treatment twice daily for 180 days
84605|NCT01874275|O1|Outcome|VECTTOR|nerve stimulator treatment twice daily for duration of study
84606|NCT01874275|O2|Outcome|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
84607|NCT01874275|O1|Outcome|VECTTOR|nerve stimulator treatment twice daily for duration of study - assessed at 180 days
84608|NCT01874275|E2|Reported Event|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
84609|NCT01874275|E1|Reported Event|VECTTOR|nerve stimulator treatment twice daily for duration of study - 365 days ...
84610|NCT01874262|B3|Baseline|Total|Total of all reporting groups
84611|NCT01874262|B2|Baseline|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
84612|NCT01874262|B1|Baseline|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
84613|NCT01874262|P2|Participant Flow|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
84614|NCT01874262|P1|Participant Flow|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
84615|NCT01874262|O2|Outcome|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
84616|NCT01874262|O1|Outcome|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
84617|NCT01874262|E2|Reported Event|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
84618|NCT01874262|E1|Reported Event|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
84619|NCT01874145|B3|Baseline|Total|Total of all reporting groups
84620|NCT01874145|B2|Baseline|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
84621|NCT01874145|B1|Baseline|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
84622|NCT01874145|P2|Participant Flow|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
84623|NCT01874145|P1|Participant Flow|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
84624|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
84625|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
84966|NCT01871402|B1|Baseline|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
84626|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
84627|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
84628|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
84629|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
84630|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
84631|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
84632|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
84777|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
84633|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
84634|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
84635|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
84636|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
84637|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
84638|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
84639|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
84640|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
84641|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
84642|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
84643|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
84644|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
84645|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
84646|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
84647|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
84648|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
84649|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
84650|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
84651|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
84652|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
84653|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
84654|NCT01874145|E4|Reported Event|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
84655|NCT01874145|E3|Reported Event|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
84656|NCT01874145|E2|Reported Event|GA 40 mg/mL TIW (Core)|Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
84778|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
84657|NCT01874145|E1|Reported Event|GA 20 mg/mL QD (Core)|Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
84658|NCT01874132|B4|Baseline|Total|Total of all reporting groups
84659|NCT01874132|B3|Baseline|Control|Non-exercising control group
84660|NCT01874132|B2|Baseline|Aerobic and Resistance Exercise Training|"Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
84661|NCT01874132|B1|Baseline|Aerobic Exercise Training|"Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
84662|NCT01874132|P3|Participant Flow|Control|Non-exercising control group
84663|NCT01874132|P2|Participant Flow|Aerobic and Resistance Exercise Training|"Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
84664|NCT01874132|P1|Participant Flow|Aerobic Exercise Training|"Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
84665|NCT01874132|O3|Outcome|Control|Non-exercising control group
84666|NCT01874132|O2|Outcome|Aerobic and Resistance Exercise Training|"Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
84667|NCT01874132|O1|Outcome|Aerobic Exercise Training|"Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
84668|NCT01874132|O3|Outcome|Control|Non-exercising control group
84669|NCT01874132|O2|Outcome|Aerobic and Resistance Exercise Training|"Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
84670|NCT01874132|O1|Outcome|Aerobic Exercise Training|"Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
84671|NCT01874132|E3|Reported Event|Control|Non-exercising control group
84672|NCT01874132|E2|Reported Event|Aerobic and Resistance Exercise Training|"Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
84673|NCT01874132|E1|Reported Event|Aerobic Exercise Training|"Dose response
Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
84674|NCT01874054|B1|Baseline|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
84675|NCT01874054|P1|Participant Flow|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
84676|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
84677|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
84678|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
84679|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
84680|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
84681|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
84682|NCT01874054|E1|Reported Event|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
84683|NCT01873989|B3|Baseline|Total|Total of all reporting groups
84684|NCT01873989|B2|Baseline|Waitlist Control|"This arm involves watchful waiting.
Waitlist control"
84685|NCT01873989|B1|Baseline|Testosterone Replacement|"Testosterone replacement for hypogonadism.
Testosterone replacement"
84687|NCT01873989|P1|Participant Flow|Testosterone Replacement|"Testosterone replacement for hypogonadism.
Testosterone replacement"
84688|NCT01873989|O2|Outcome|Waitlist Control|"This arm involves watchful waiting.
Waitlist control"
84689|NCT01873989|O1|Outcome|Testosterone Replacement|"Testosterone replacement for hypogonadism.
Testosterone replacement"
84690|NCT01873989|O2|Outcome|Waitlist Control|"This arm involves watchful waiting.
Waitlist control"
84691|NCT01873989|O1|Outcome|Testosterone Replacement|"Testosterone replacement for hypogonadism.
Testosterone replacement"
84692|NCT01873989|O2|Outcome|Waitlist Control|"This arm involves watchful waiting.
Waitlist control"
84693|NCT01873989|O1|Outcome|Testosterone Replacement|"Testosterone replacement for hypogonadism.
Testosterone replacement"
84694|NCT01873989|E2|Reported Event|Waitlist Control|"This arm involves watchful waiting.
Waitlist control"
84695|NCT01873989|E1|Reported Event|Testosterone Replacement|"Testosterone replacement for hypogonadism.
Testosterone replacement"
84696|NCT01873950|B1|Baseline|All Study Participants|Participants who were randomized to receive either ranolazine, dofetilide, verapamil, quinidine or placebo.
84697|NCT01873950|P5|Participant Flow|Placebo|Single oral dose of Placebo (comparison group). Each subject received each drug only once in a randomized sequence (10 sequences in total).
84779|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
84698|NCT01873950|P4|Participant Flow|Quinidine Sulfate 400 mg|Single oral dose of Quinidine sulfate 400mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
84699|NCT01873950|P3|Participant Flow|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
84700|NCT01873950|P2|Participant Flow|Dofetilide 500 mcg|Single oral dose of Dofetilide 500mcg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
84701|NCT01873950|P1|Participant Flow|Ranolazine 1500 mg|Single oral dose of Ranolazine 1500mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
84702|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
84703|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
84704|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
84705|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
84706|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
84707|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
84708|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
84709|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
84710|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
84711|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
84712|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
84713|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
84714|NCT01873950|E5|Reported Event|Placebo|Single oral dose of Placebo (comparison group)
84715|NCT01873950|E4|Reported Event|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
84716|NCT01873950|E3|Reported Event|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
84717|NCT01873950|E2|Reported Event|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
84718|NCT01873950|E1|Reported Event|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
84719|NCT01873859|B3|Baseline|Total|Total of all reporting groups
84720|NCT01873859|B2|Baseline|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
84721|NCT01873859|B1|Baseline|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.
Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
84722|NCT01873859|P2|Participant Flow|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
84723|NCT01873859|P1|Participant Flow|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.
Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
84724|NCT01873859|O2|Outcome|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
84725|NCT01873859|O1|Outcome|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.
Metformin: rise of creatinin 48 hr after recieving contrast media."
84726|NCT01873859|O2|Outcome|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
84727|NCT01873859|O1|Outcome|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.
Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
84728|NCT01873859|E2|Reported Event|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
84729|NCT01873859|E1|Reported Event|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.
Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
84730|NCT01873729|B1|Baseline|Naltrexone|"Naltrexone
Naltrexone: Adults with ADHD"
84731|NCT01873729|P1|Participant Flow|Naltrexone|"Naltrexone
Naltrexone: Adults with ADHD"
84732|NCT01873729|O1|Outcome|Naltrexone|"Naltrexone + Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS)
Naltrexone: Adults with ADHD"
84733|NCT01873729|O1|Outcome|Naltrexone|"Naltrexone + Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS)
Naltrexone: Adults with ADHD"
84734|NCT01873729|E1|Reported Event|Naltrexone|"Naltrexone
Naltrexone: Adults with ADHD"
84735|NCT01873417|B1|Baseline|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
84967|NCT01871402|P2|Participant Flow|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
84736|NCT01873417|P1|Participant Flow|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
84737|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
84738|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
84739|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
84740|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
84741|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
84742|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
84743|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
84744|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
84745|NCT01873417|E1|Reported Event|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
84746|NCT01872819|B1|Baseline|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.
antitumor drug screening assay: Undergo high throughput drug sensitivity assay
chemotherapy: Patients receive 1 of 160 possible interventions
biological therapy: Patients receive 1 of 160 possible interventions"
84747|NCT01872819|P1|Participant Flow|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.
antitumor drug screening assay: Undergo high throughput drug sensitivity assay
chemotherapy: Patients receive 1 of 160 possible interventions
biological therapy: Patients receive 1 of 160 possible interventions"
84748|NCT01872819|O1|Outcome|Treated Patients|14 patients were treated.
84749|NCT01872819|E1|Reported Event|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.
antitumor drug screening assay: Undergo high throughput drug sensitivity assay
chemotherapy: Patients receive 1 of 160 possible interventions
biological therapy: Patients receive 1 of 160 possible interventions"
84750|NCT01872715|B1|Baseline|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea"
84751|NCT01872715|P1|Participant Flow|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea"
84752|NCT01872715|O5|Outcome|Very Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
84753|NCT01872715|O4|Outcome|Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
84754|NCT01872715|O3|Outcome|Neither Satisfied Nor Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
84755|NCT01872715|O2|Outcome|Satisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
84756|NCT01872715|O1|Outcome|Very Satisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
84757|NCT01872715|O5|Outcome|4 = Severe|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
84758|NCT01872715|O4|Outcome|3 = Moderate|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
84759|NCT01872715|O3|Outcome|2 = Mild|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
84760|NCT01872715|O2|Outcome|1 = Near Clear|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
84761|NCT01872715|O1|Outcome|0 = Clear|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
84762|NCT01872715|O1|Outcome|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea"
84763|NCT01872715|O1|Outcome|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea"
84764|NCT01872715|E1|Reported Event|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea"
84765|NCT01872611|B3|Baseline|Total|Total of all reporting groups
84766|NCT01872611|B2|Baseline|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
84767|NCT01872611|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
84768|NCT01872611|P2|Participant Flow|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
84769|NCT01872611|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
84770|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
84771|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
84772|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
84773|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
84774|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
84775|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
84776|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
84780|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
84781|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
84782|NCT01872611|E4|Reported Event|Posttreatment|All participants after cessation of study treatment up to study exit
84783|NCT01872611|E3|Reported Event|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
84784|NCT01872611|E2|Reported Event|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
84785|NCT01872611|E1|Reported Event|Pretreatment|All participants who consented to participate in the study prior to the initiation of study treatment
84786|NCT01872078|B5|Baseline|Total|Total of all reporting groups
84787|NCT01872078|B4|Baseline|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
84788|NCT01872078|B3|Baseline|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
84789|NCT01872078|B2|Baseline|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
84790|NCT01872078|B1|Baseline|Placebo|Two matching placebo tablets for both the morning and evening doses
84791|NCT01872078|P4|Participant Flow|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
84792|NCT01872078|P3|Participant Flow|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
84793|NCT01872078|P2|Participant Flow|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
84794|NCT01872078|P1|Participant Flow|Placebo|Two matching placebo tablets for both the morning and evening doses
84795|NCT01872078|O4|Outcome|40 mg AZD4901 Bid|40 mg AZD4901 twice daily administered orally
84796|NCT01872078|O3|Outcome|20 mg AZD4901 Bid|20 mg AZD4901 twice daily administered orally
84797|NCT01872078|O2|Outcome|20 mg AZD4901 qd|20 mg AZD4901 once daily administered orally
84798|NCT01872078|O1|Outcome|Placebo|Two matching placebo tablets for both the morning and evening doses
84799|NCT01872078|E4|Reported Event|Placebo|Two matching placebo tablets for both the morning and evening doses
84800|NCT01872078|E3|Reported Event|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
84801|NCT01872078|E2|Reported Event|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
84802|NCT01872078|E1|Reported Event|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
84803|NCT01871870|B1|Baseline|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
84804|NCT01871870|P1|Participant Flow|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
84805|NCT01871870|O1|Outcome|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
84968|NCT01871402|P1|Participant Flow|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
84969|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
84806|NCT01871870|O1|Outcome|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
84807|NCT01871870|E1|Reported Event|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
84808|NCT01871805|B7|Baseline|Total|Total of all reporting groups
85252|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
84809|NCT01871805|B6|Baseline|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84810|NCT01871805|B5|Baseline|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84811|NCT01871805|B4|Baseline|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84812|NCT01871805|B3|Baseline|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84813|NCT01871805|B2|Baseline|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84814|NCT01871805|B1|Baseline|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84815|NCT01871805|P6|Participant Flow|Alectinib 600 mg (Fed): Phase II|Participants received 150 mg alectinib capsules orally to make a dose of 600 mg BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84816|NCT01871805|P5|Participant Flow|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84817|NCT01871805|P4|Participant Flow|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84818|NCT01871805|P3|Participant Flow|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84819|NCT01871805|P2|Participant Flow|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84820|NCT01871805|P1|Participant Flow|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 milligrams (mg) alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg twice daily (BID) dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84821|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84822|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84823|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84824|NCT01871805|O7|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84825|NCT01871805|O6|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84826|NCT01871805|O5|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84970|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
84827|NCT01871805|O4|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84828|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84829|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84830|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84831|NCT01871805|O9|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84832|NCT01871805|O8|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
85253|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
84833|NCT01871805|O7|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84834|NCT01871805|O6|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84835|NCT01871805|O5|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84836|NCT01871805|O4|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84837|NCT01871805|O3|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84838|NCT01871805|O2|Outcome|Alectinib 240 mg Once and 300 mg BID (Fed): Phase I|Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84839|NCT01871805|O1|Outcome|Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I|Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84840|NCT01871805|O7|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84841|NCT01871805|O6|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84842|NCT01871805|O5|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84843|NCT01871805|O4|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84844|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84845|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84846|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84847|NCT01871805|O9|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84848|NCT01871805|O8|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84849|NCT01871805|O7|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84850|NCT01871805|O6|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84851|NCT01871805|O5|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84852|NCT01871805|O4|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84853|NCT01871805|O3|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84854|NCT01871805|O2|Outcome|Alectinib 240 mg Once and 300 mg BID (Fed): Phase I|Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84855|NCT01871805|O1|Outcome|Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I|Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
86120|NCT01860976|B1|Baseline|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
84856|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84857|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84858|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84859|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84860|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84861|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84862|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84863|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84864|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84865|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84866|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84867|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84868|NCT01871805|O5|Outcome|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84869|NCT01871805|O4|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84870|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84871|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84872|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84873|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84874|NCT01871805|O5|Outcome|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84875|NCT01871805|O4|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84876|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84877|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84878|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84879|NCT01871805|E6|Reported Event|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84880|NCT01871805|E5|Reported Event|Alectinib 900 mg (Fed): Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84881|NCT01871805|E4|Reported Event|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84985|NCT01871285|B1|Baseline|MSE Dose Group 1|Morning and evening dose of buprenorphine HCl buccal film (300 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
84882|NCT01871805|E3|Reported Event|Alectinib 600 mg (Fed): Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84883|NCT01871805|E2|Reported Event|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84884|NCT01871805|E1|Reported Event|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
84885|NCT01871558|B3|Baseline|Total|Total of all reporting groups
84886|NCT01871558|B2|Baseline|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84887|NCT01871558|B1|Baseline|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84888|NCT01871558|P2|Participant Flow|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84889|NCT01871558|P1|Participant Flow|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84890|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84891|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84892|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84893|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84894|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84895|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84896|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84897|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84898|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84899|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84900|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84901|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84902|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84903|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84904|NCT01871558|E2|Reported Event|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84905|NCT01871558|E1|Reported Event|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
84906|NCT01871532|B3|Baseline|Total|Total of all reporting groups
84907|NCT01871532|B2|Baseline|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84908|NCT01871532|B1|Baseline|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84909|NCT01871532|P2|Participant Flow|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84910|NCT01871532|P1|Participant Flow|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84911|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84912|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84913|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84914|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84915|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84916|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84917|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84918|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84971|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
84972|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
84973|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
84919|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84920|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84921|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84922|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84923|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84924|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84925|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84926|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84927|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84928|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84929|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84930|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84931|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84932|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84933|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84934|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84935|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84936|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84937|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84938|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84939|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84940|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84941|NCT01871532|E2|Reported Event|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84942|NCT01871532|E1|Reported Event|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
84943|NCT01871519|B1|Baseline|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84944|NCT01871519|P1|Participant Flow|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84945|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84946|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84947|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84948|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84974|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
84949|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84950|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84951|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84952|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices"
84953|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
85014|NCT01871142|B1|Baseline|Entire Study Population|All enrolled participant baseline data
84954|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84955|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84956|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84957|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84958|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84959|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84960|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84961|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84962|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84963|NCT01871519|E1|Reported Event|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
84964|NCT01871402|B3|Baseline|Total|Total of all reporting groups
84981|NCT01871402|E2|Reported Event|Vehicle Arm|"Topical lotion, applied twice daily
Vehicle Lotion"
84982|NCT01871402|E1|Reported Event|Active Arm|"Topical lotion, applied twice daily
000-0551 Lotion"
84983|NCT01871285|B3|Baseline|Total|Total of all reporting groups
84984|NCT01871285|B2|Baseline|MSE Dose Group 2|Morning and evening dose of buprenorphine HCl buccal film (450 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
85246|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
84986|NCT01871285|P4|Participant Flow|MSE Dose Group 2 (BA) - ATC Opioid Then Buprenorphine (450 μg)|MSE Dose Group 2 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
84987|NCT01871285|P3|Participant Flow|MSE Dose Group 2 (AB) - Buprenorphine (450 μg) Then ATC Opioid|MSE Dose Group 2 receiving treatment sequence AB with A being buprenorphine HCl buccal film (450 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
84988|NCT01871285|P2|Participant Flow|MSE Dose Group 1 (BA) - ATC Opioid Then Buprenorphine (300 μg)|MSE Dose Group 1 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
84989|NCT01871285|P1|Participant Flow|MSE Dose Group 1 (AB) - Buprenorphine (300 μg) Then ATC Opioid|MSE Dose Group 1 receiving treatment sequence AB with A being buprenorphine hydrochloride (HCl) buccal film (300 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
84990|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
84991|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
84992|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
84993|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
84994|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
84995|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
84996|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
84997|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
84998|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
84999|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
85000|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
85001|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
85002|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
85003|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
85004|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
85005|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
85006|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
85007|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
85008|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
85009|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
85010|NCT01871285|E4|Reported Event|MSE Dose Group 2 - ATC Opioid|Subjects in MSE Dose Group 2 who received at least 1 dose of assigned ATC opioid in either period
85011|NCT01871285|E3|Reported Event|MSE Dose Group 2 - Buprenorphine|Subjects in MSE Dose Group 2 who received at least one 450-μg buprenorphine HCl buccal film in either period
85012|NCT01871285|E2|Reported Event|MSE Dose Group 1 - ATC Opioid|Subjects in MSE Dose Group 1 who received at least 1 dose of assigned ATC opioid in either period
85013|NCT01871285|E1|Reported Event|MSE Dose Group 1 - Buprenorphine|Subjects in MSE Dose Group 1 who received at least one 300-μg buprenorphine HCl buccal film in either period
85015|NCT01871142|P1|Participant Flow|Randomized Crossover Assignment|Participants will receive, in a random order, a placebo prior to exercise in normoxia, a placebo prior to exercise in hypoxia, 1000 mg of Aes-103 prior to exercise in hypoxia, and 3000 mg of Aes-103 prior to exercise in hypoxia. Each intervention is separated by a 7 day washout period.
85016|NCT01871142|O4|Outcome|3000mg Aes-103 + Hypoxia|"Number of participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)"
85017|NCT01871142|O3|Outcome|1000mg Aes-103 + Hypoxia|"Number of participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)"
85018|NCT01871142|O2|Outcome|Placebo + Hypoxia|"Number of participants receiving placebo in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Normoxia (21% oxygen)"
85019|NCT01871142|O1|Outcome|Placebo + Normoxia|"Number of participants receiving placebo in normoxic conditions. Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Normoxia (21% oxygen)"
85020|NCT01871142|O4|Outcome|3000mg Aes-103 + Hypoxia|"Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)"
85021|NCT01871142|O3|Outcome|1000mg Aes-103 + Hypoxia|"Randomized crossover assignment for each participant.
Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)"
85022|NCT01871142|O2|Outcome|Placebo + Hypoxia|"Randomized crossover assignment for each participant.
Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% Oxygen)"
85023|NCT01871142|O1|Outcome|Palcebo + Normoxia|"Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Normoxia (21% oxygen)"
85024|NCT01871142|E4|Reported Event|Hypoxia 3000 mg Aes-103 + Hypoxia|"Participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen"
85025|NCT01871142|E3|Reported Event|1000 mg Aes-103 + Hypoxia|"Participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)"
85026|NCT01871142|E2|Reported Event|Placebo + Hypoxia|"Participants receiving placebo in Hypoxic conditions Randomized crossover assignment for each participant Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% Oxygen)"
85027|NCT01871142|E1|Reported Event|Placebo + Normoxia|"Participants receiving placebo in normoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Normoxia (21% oxygen)"
85028|NCT01871090|B3|Baseline|Total|Total of all reporting groups
85029|NCT01871090|B2|Baseline|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
85030|NCT01871090|B1|Baseline|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Unpaired remote monitoring transmitter"
85031|NCT01871090|P2|Participant Flow|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
85032|NCT01871090|P1|Participant Flow|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Unpaired remote monitoring transmitter"
85033|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
85034|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Unpaired remote monitoring transmitter"
85035|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
85036|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Unpaired remote monitoring transmitter"
85037|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
85038|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Unpaired remote monitoring transmitter"
85039|NCT01871090|E2|Reported Event|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
85040|NCT01871090|E1|Reported Event|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Unpaired remote monitoring transmitter"
85041|NCT01870999|B4|Baseline|Total|Total of all reporting groups
85042|NCT01870999|B3|Baseline|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85239|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85043|NCT01870999|B2|Baseline|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85044|NCT01870999|B1|Baseline|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85247|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85045|NCT01870999|P3|Participant Flow|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85046|NCT01870999|P2|Participant Flow|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85047|NCT01870999|P1|Participant Flow|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85048|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85049|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85050|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85051|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85052|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85053|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85054|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85055|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85056|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85057|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85058|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85059|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85060|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85061|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85062|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85063|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85064|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85248|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
86121|NCT01860976|P2|Participant Flow|Placebo|Placebo, self-administered subcutaneously, once weekly.
85065|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85066|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85067|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85068|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85069|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85070|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85071|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85072|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85073|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85074|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85075|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85076|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85077|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85078|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85079|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85080|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85081|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85082|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85083|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85084|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85249|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85250|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85085|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85086|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85087|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85088|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85089|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85090|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85091|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85092|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85093|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85094|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85095|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85096|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85097|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85098|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85099|NCT01870999|E3|Reported Event|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85100|NCT01870999|E2|Reported Event|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85101|NCT01870999|E1|Reported Event|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
85102|NCT01870973|B3|Baseline|Total|Total of all reporting groups
85194|NCT01870583|O3|Outcome|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery
Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
85103|NCT01870973|B2|Baseline|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)
no root canal treatment"
85104|NCT01870973|B1|Baseline|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)
root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
85105|NCT01870973|P2|Participant Flow|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)
no root canal treatment"
85251|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85106|NCT01870973|P1|Participant Flow|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)
root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
85107|NCT01870973|O2|Outcome|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)
no root canal treatment"
85108|NCT01870973|O1|Outcome|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)
root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
85109|NCT01870973|E2|Reported Event|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)
no root canal treatment"
85110|NCT01870973|E1|Reported Event|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)
root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
85111|NCT01870921|B1|Baseline|Ticargrelor|90 mg/tablet, 1 tablet bid
85112|NCT01870921|P1|Participant Flow|Ticargrelor|90 mg/tablet, 1 tablet bid
85113|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
85114|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
85115|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
85116|NCT01870921|E1|Reported Event|Ticargrelor|90 mg/tablet, 1 tablet bid
85117|NCT01870856|B3|Baseline|Total|Total of all reporting groups
85118|NCT01870856|B2|Baseline|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
85119|NCT01870856|B1|Baseline|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
85120|NCT01870856|P2|Participant Flow|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
85121|NCT01870856|P1|Participant Flow|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
85122|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
85123|NCT01870856|O1|Outcome|DAILIES TOTAL 1, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
85124|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
85125|NCT01870856|O1|Outcome|DAILIES TOTAL 1, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
85126|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
85127|NCT01870856|O1|Outcome|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
85128|NCT01870856|E2|Reported Event|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
85129|NCT01870856|E1|Reported Event|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
85130|NCT01870843|B1|Baseline|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85131|NCT01870843|P1|Participant Flow|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85132|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85133|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85134|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85135|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85136|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85137|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85138|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85139|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85140|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85141|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85142|NCT01870843|E1|Reported Event|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
85143|NCT01870739|B3|Baseline|Total|Total of all reporting groups
85144|NCT01870739|B2|Baseline|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85145|NCT01870739|B1|Baseline|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85146|NCT01870739|P2|Participant Flow|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85147|NCT01870739|P1|Participant Flow|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85148|NCT01870739|O6|Outcome|Olmesartan 40mg +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
85149|NCT01870739|O5|Outcome|Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
85150|NCT01870739|O4|Outcome|Maintenance Dose: Olmesartan 40 mg|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
85151|NCT01870739|O3|Outcome|Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
85152|NCT01870739|O2|Outcome|Initiation Dose: Olmesartan 20mg|Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
85153|NCT01870739|O1|Outcome|Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)|Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
85154|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85155|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85156|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85157|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85158|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85159|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85160|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85161|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85162|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85163|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85164|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85165|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85166|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85167|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85168|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85169|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85170|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85171|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
85172|NCT01870739|E6|Reported Event|Olmesartan 40mg +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
85173|NCT01870739|E5|Reported Event|Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
85174|NCT01870739|E4|Reported Event|Maintenance Dose: Olmesartan 40 mg|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
85175|NCT01870739|E3|Reported Event|Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
85176|NCT01870739|E2|Reported Event|Initiation Dose: Olmesartan 20mg|Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
85177|NCT01870739|E1|Reported Event|Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)|Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
85178|NCT01870596|B3|Baseline|Total|Total of all reporting groups
85179|NCT01870596|B2|Baseline|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.
Cytarabine: Given IV
Laboratory Biomarker Analysis: Correlative studies"
85180|NCT01870596|B1|Baseline|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.
Cytarabine: Given IV
CHK1 Inhibitor SCH 900776: Given IV
Laboratory Biomarker Analysis: Correlative studies"
85181|NCT01870596|P2|Participant Flow|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.
Cytarabine: Given IV
Laboratory Biomarker Analysis: Correlative studies"
85182|NCT01870596|P1|Participant Flow|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.
Cytarabine: Given IV
CHK1 Inhibitor SCH 900776: Given IV
Laboratory Biomarker Analysis: Correlative studies"
85183|NCT01870596|O2|Outcome|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.
Cytarabine: Given IV
Laboratory Biomarker Analysis: Correlative studies"
85184|NCT01870596|O1|Outcome|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.
Cytarabine: Given IV
CHK1 Inhibitor SCH 900776: Given IV
Laboratory Biomarker Analysis: Correlative studies"
85185|NCT01870596|E2|Reported Event|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.
Cytarabine: Given IV
Laboratory Biomarker Analysis: Correlative studies"
85186|NCT01870596|E1|Reported Event|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.
Cytarabine: Given IV
CHK1 Inhibitor SCH 900776: Given IV
Laboratory Biomarker Analysis: Correlative studies"
85187|NCT01870583|B4|Baseline|Total|Total of all reporting groups
85188|NCT01870583|B3|Baseline|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery
Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
85189|NCT01870583|B2|Baseline|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery
Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
85190|NCT01870583|B1|Baseline|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.
Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
85191|NCT01870583|P3|Participant Flow|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery
Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
85192|NCT01870583|P2|Participant Flow|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery
Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
85193|NCT01870583|P1|Participant Flow|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.
Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
85238|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85195|NCT01870583|O2|Outcome|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery
Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
85196|NCT01870583|O1|Outcome|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.
Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
85197|NCT01870583|E3|Reported Event|Iodine Povidone|"Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery
Iodine povidone: Iodine skin preparation solution prior to cesarean delivery"
85198|NCT01870583|E2|Reported Event|Chlorhexidine|"Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery
Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery"
85199|NCT01870583|E1|Reported Event|Combination Iodine and Chlorhexidine|"The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.
Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery"
85200|NCT01870388|B3|Baseline|Total|Total of all reporting groups
85201|NCT01870388|B2|Baseline|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
85202|NCT01870388|B1|Baseline|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
85203|NCT01870388|P2|Participant Flow|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
85204|NCT01870388|P1|Participant Flow|Baricitinib (Healthy Participants)|Group 1: A single 4-milligram (mg) dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
85205|NCT01870388|O2|Outcome|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
85206|NCT01870388|O1|Outcome|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
85207|NCT01870388|O2|Outcome|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with moderate hepatic impairment as classified by Child-Pugh B.
85208|NCT01870388|O1|Outcome|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with normal hepatic function.
85209|NCT01870388|E2|Reported Event|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
85210|NCT01870388|E1|Reported Event|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
85211|NCT01869959|B5|Baseline|Total|Total of all reporting groups
85212|NCT01869959|B4|Baseline|Placebo|Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.
85213|NCT01869959|B3|Baseline|20 mg LY2405319|20 mg LY2405319 injected SC once daily for 28 days.
85214|NCT01869959|B2|Baseline|10 mg LY2405319|10 mg LY2405319 injected SC once daily for 28 days.
85215|NCT01869959|B1|Baseline|3 mg LY2405319|3 mg LY2405319 injected SC once daily for 28 days.
85216|NCT01869959|P5|Participant Flow|All Randomized Participants|All participants randomized in the study.
85217|NCT01869959|P4|Participant Flow|Placebo|Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.
85218|NCT01869959|P3|Participant Flow|20 mg LY2405319|20 mg LY2405319 injected SC once daily for 28 days.
85219|NCT01869959|P2|Participant Flow|10 mg LY2405319|10 mg LY2405319 injected SC once daily for 28 days.
85220|NCT01869959|P1|Participant Flow|3 mg LY2405319|3 milligrams (mg) LY2405319 injected SC once daily for 28 days.
85221|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85222|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85223|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85224|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85225|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85226|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85227|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85228|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85229|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85230|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85231|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85232|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85233|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85234|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85235|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85236|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85237|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85240|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85241|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85242|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85243|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85244|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85245|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85254|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85255|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85256|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85257|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85258|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85259|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85260|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85261|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85262|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85263|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85264|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85265|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85266|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85267|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85268|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85269|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85270|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85271|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85272|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85273|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85274|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85275|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85276|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85277|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85278|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85279|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85280|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85281|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85282|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85283|NCT01869959|E4|Reported Event|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
85284|NCT01869959|E3|Reported Event|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
85285|NCT01869959|E2|Reported Event|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
85286|NCT01869959|E1|Reported Event|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
85287|NCT01869699|B3|Baseline|Total|Total of all reporting groups
85288|NCT01869699|B2|Baseline|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
85289|NCT01869699|B1|Baseline|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
85290|NCT01869699|P2|Participant Flow|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
85291|NCT01869699|P1|Participant Flow|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
85292|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
85293|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
85294|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
85295|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
85296|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
85297|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
85298|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
85299|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
85382|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
85300|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
85301|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
85302|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
85303|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
85304|NCT01869699|O2|Outcome|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
85305|NCT01869699|O1|Outcome|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
85306|NCT01869699|E2|Reported Event|Acetaminophen|"Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes
Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes"
85307|NCT01869699|E1|Reported Event|Normal Saline Placebo|"Normal saline 100 mLs intravenous, administered over 15 minutes
Placebo: Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes"
85308|NCT01869686|B1|Baseline|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
85309|NCT01869686|P1|Participant Flow|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
85310|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
85311|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
85312|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
85313|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
85314|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
85315|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
85316|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
85317|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
85318|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
85319|NCT01869686|E1|Reported Event|Denosumab 60 mg SC|
85320|NCT01869647|B4|Baseline|Total|Total of all reporting groups
85321|NCT01869647|B3|Baseline|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.
low likelihood of stone group: No imaging"
85322|NCT01869647|B2|Baseline|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.
moderate likelihood of stone group: Regular CT or Low Dose CT scan"
85323|NCT01869647|B1|Baseline|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.
high likelihood of stone group: Ultra low dose CT scan"
85324|NCT01869647|P3|Participant Flow|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.
low likelihood of stone group: No imaging"
85325|NCT01869647|P2|Participant Flow|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.
moderate likelihood of stone group: Regular CT or Low Dose CT scan"
85326|NCT01869647|P1|Participant Flow|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.
high likelihood of stone group: Ultra low dose CT scan"
85327|NCT01869647|O3|Outcome|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.
low likelihood of stone group: No imaging"
85328|NCT01869647|O2|Outcome|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.
moderate likelihood of stone group: Regular CT or Low Dose CT scan"
85329|NCT01869647|O1|Outcome|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.
high likelihood of stone group: Ultra low dose CT scan"
85330|NCT01869647|O3|Outcome|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.
low likelihood of stone group: No imaging"
85331|NCT01869647|O2|Outcome|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.
moderate likelihood of stone group: Regular CT or Low Dose CT scan"
85332|NCT01869647|O1|Outcome|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.
high likelihood of stone group: Ultra low dose CT scan"
85333|NCT01869647|E3|Reported Event|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.
low likelihood of stone group: No imaging"
85334|NCT01869647|E2|Reported Event|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.
moderate likelihood of stone group: Regular CT or Low Dose CT scan"
85335|NCT01869647|E1|Reported Event|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.
high likelihood of stone group: Ultra low dose CT scan"
85336|NCT01869478|B3|Baseline|Total|Total of all reporting groups
85337|NCT01869478|B2|Baseline|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
85338|NCT01869478|B1|Baseline|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
85339|NCT01869478|P2|Participant Flow|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
85340|NCT01869478|P1|Participant Flow|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
85341|NCT01869478|O2|Outcome|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
85342|NCT01869478|O1|Outcome|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
85343|NCT01869478|O2|Outcome|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
85344|NCT01869478|O1|Outcome|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
85345|NCT01869478|E2|Reported Event|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
85346|NCT01869478|E1|Reported Event|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
85347|NCT01869075|B7|Baseline|Total|Total of all reporting groups
85348|NCT01869075|B6|Baseline|HFS - Usual Care|Usual Care as provided at the hospital.
85377|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
85349|NCT01869075|B5|Baseline|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85350|NCT01869075|B4|Baseline|MGS - Usual Care|Usual Care as provided at the hospital.
85351|NCT01869075|B3|Baseline|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85352|NCT01869075|B2|Baseline|AMI - Usual Care|Usual care as provided at the hospital.
85417|NCT01868633|O1|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone"
85353|NCT01869075|B1|Baseline|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85354|NCT01869075|P6|Participant Flow|HFS - Usual Care|Usual care provided at the hospital
85355|NCT01869075|P5|Participant Flow|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85356|NCT01869075|P4|Participant Flow|MGS - Usual Care|Usual care provided at the hospital
85357|NCT01869075|P3|Participant Flow|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85358|NCT01869075|P2|Participant Flow|AMI - Usual Care|Usual care provided at the hospital
85359|NCT01869075|P1|Participant Flow|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85360|NCT01869075|O6|Outcome|HFS - Usual Care|Usual Care as provided at the hospital
85361|NCT01869075|O5|Outcome|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85362|NCT01869075|O4|Outcome|MGS - Usual Care|Usual Care as provided at the hospital
85363|NCT01869075|O3|Outcome|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85364|NCT01869075|O2|Outcome|AMI - Usual Care|Usual care as provided at the hospital
85365|NCT01869075|O1|Outcome|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85366|NCT01869075|E6|Reported Event|HFS - Usual Care|Usual Care as provided at the hospital
85367|NCT01869075|E5|Reported Event|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85368|NCT01869075|E4|Reported Event|MGS - Usual Care|Usual Care as provided at the hospital
85369|NCT01869075|E3|Reported Event|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85370|NCT01869075|E2|Reported Event|AMI - Usual Care|Usual care as provided at the hospital
85371|NCT01869075|E1|Reported Event|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
85372|NCT01868997|B3|Baseline|Total|Total of all reporting groups
85373|NCT01868997|B2|Baseline|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
85374|NCT01868997|B1|Baseline|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
85375|NCT01868997|P2|Participant Flow|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
85376|NCT01868997|P1|Participant Flow|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
85575|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
85378|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
85379|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
85380|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
85381|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
85453|NCT01868243|P1|Participant Flow|Dabigatran|"Dabigatran 110 mg BID
Dabigatran: Group 1 - Dabigatran 110 mg"
85383|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
85384|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
85385|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
85386|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
85387|NCT01868997|O2|Outcome|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
85388|NCT01868997|O1|Outcome|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
85389|NCT01868997|E2|Reported Event|Teprotumumab|Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.
85390|NCT01868997|E1|Reported Event|Placebo|A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.
85391|NCT01868893|B1|Baseline|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
85392|NCT01868893|P1|Participant Flow|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
85393|NCT01868893|O1|Outcome|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
85394|NCT01868893|O1|Outcome|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
85395|NCT01868893|O2|Outcome|Chlorambucil|Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6.
85396|NCT01868893|O1|Outcome|Obinutuzumab|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6.
85397|NCT01868893|E1|Reported Event|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
85398|NCT01868776|B3|Baseline|Total|Total of all reporting groups
85399|NCT01868776|B2|Baseline|Nonbuffered|nonbuffered lidocaine
85400|NCT01868776|B1|Baseline|Buffered|buffered lidocaine
85401|NCT01868776|P2|Participant Flow|Nonbuffered|nonbuffered lidocaine
85402|NCT01868776|P1|Participant Flow|Buffered|buffered lidocaine
85403|NCT01868776|O2|Outcome|Nonbuffered Lidocaine|"4% lidocaine with 1:100,000 epinephrine
nonbuffered lidocaine"
85404|NCT01868776|O1|Outcome|Buffered Lidocaine|"4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate.
buffered lidocaine"
85405|NCT01868776|E2|Reported Event|Nonbuffered|nonbuffered lidocaine
85406|NCT01868776|E1|Reported Event|Buffered|buffered lidocaine
85407|NCT01868633|B3|Baseline|Total|Total of all reporting groups
85408|NCT01868633|B2|Baseline|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo"
85409|NCT01868633|B1|Baseline|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone"
85410|NCT01868633|P2|Participant Flow|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo"
85411|NCT01868633|P1|Participant Flow|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone"
85412|NCT01868633|O2|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo"
85413|NCT01868633|O1|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone"
85414|NCT01868633|O2|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo"
85415|NCT01868633|O1|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone"
85416|NCT01868633|O2|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo"
86893|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
85418|NCT01868633|E2|Reported Event|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo"
85419|NCT01868633|E1|Reported Event|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone"
85420|NCT01868542|B3|Baseline|Total|Total of all reporting groups
85421|NCT01868542|B2|Baseline|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
85422|NCT01868542|B1|Baseline|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
85423|NCT01868542|P2|Participant Flow|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
85424|NCT01868542|P1|Participant Flow|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
85425|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
85426|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
85443|NCT01868503|O1|Outcome|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.
lapatinib ditosylate: Given PO
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
85507|NCT01867710|P2|Participant Flow|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
85427|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
85454|NCT01868243|O2|Outcome|Warfarin|"Warfarin adjusted-dose
Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
85455|NCT01868243|O1|Outcome|Dabigatran|"Dabigatran 110 mg BID
Dabigatran: Group 1 - Dabigatran 110 mg"
85456|NCT01868243|O2|Outcome|Warfarin|"Warfarin adjusted-dose
Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
85457|NCT01868243|O1|Outcome|Dabigatran|"Dabigatran 110 mg BID
Dabigatran: Group 1 - Dabigatran 110 mg"
85458|NCT01868243|E2|Reported Event|Warfarin|"Warfarin adjusted-dose
Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
85428|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
85429|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
85430|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
85431|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
85432|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
85433|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
85444|NCT01868503|O1|Outcome|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.
lapatinib ditosylate: Given PO
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
85506|NCT01867710|P3|Participant Flow|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
85434|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
85435|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
85459|NCT01868243|E1|Reported Event|Dabigatran|"Dabigatran 110 mg BID
Dabigatran: Group 1 - Dabigatran 110 mg"
85460|NCT01868074|B3|Baseline|Total|Total of all reporting groups
85461|NCT01868074|B2|Baseline|Usual Care|Participants were instructed to wear their usual footwear over the course of their pregnancy.
85462|NCT01868074|B1|Baseline|Customized Insole|These participants were casted for customized insoles.
85436|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
85437|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
85438|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
85439|NCT01868542|E2|Reported Event|Insulin Detemir (2-4-6-8 Algorithm )|"A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done :
>10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir."
85440|NCT01868542|E1|Reported Event|Insulin Detemir (3-0-3 Algorithm )|"A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done :
>6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir."
85441|NCT01868503|B1|Baseline|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.
lapatinib ditosylate: Given PO
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
85442|NCT01868503|P1|Participant Flow|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.
lapatinib ditosylate: Given PO
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
85505|NCT01867710|P4|Participant Flow|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
85445|NCT01868503|O1|Outcome|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.
lapatinib ditosylate: Given PO
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
85446|NCT01868503|O1|Outcome|All Participants|
85447|NCT01868503|O1|Outcome|Lapatinib Plus Radiation Therapy|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis.
lapatinib ditosylate: Given PO
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
85448|NCT01868503|E1|Reported Event|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.
lapatinib ditosylate: Given PO
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
85449|NCT01868243|B3|Baseline|Total|Total of all reporting groups
85450|NCT01868243|B2|Baseline|Warfarin|"Warfarin adjusted-dose
Warfarin: Warfarin adjusted-dose"
85451|NCT01868243|B1|Baseline|Dabigatran|"Dabigatran 110 mg BID
Dabigatran: Group 1 - Dabigatran 110 mg (50 patients)"
85452|NCT01868243|P2|Participant Flow|Warfarin|"Warfarin adjusted-dose
Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
85463|NCT01868074|P2|Participant Flow|Usual Care Group|Participants in the control group were instructed to wear their usual footwear over the course of their pregnancy.
85464|NCT01868074|P1|Participant Flow|Customized Insole Group|Each participant in the intervention group had her insole customized to fit her typical daily footwear and was instructed to wear the insoles as often as possible. Participants in the intervention group had their feet molded by a certified orthotist, using a 3M, soft cast. The casting was done in a non-weight bearing, hind-foot neutral position so the insoles would preserve the long transverse arch and maintain a biomechanically efficient state to control motion at the foot and ankle. These castings were used to custom form insoles with the following characteristics: Footlights athletic or dress model (per participant shoe preference), with 3/16” semi-rigid shells, no arch fill, extrinsic rearfoot and standard intrinsic forefoot posting. A research team member not involved with outcome measurements met with the participants to give them their insoles and confirm they fit.
85465|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
85466|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
85467|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
85468|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
85469|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
85470|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
85471|NCT01868074|E2|Reported Event|Usual Care|Participants were instructed to wear their usual footwear over the course of their pregnancy.
85472|NCT01868074|E1|Reported Event|Customized Insole|These participants were casted for customized insoles.
85473|NCT01868035|B1|Baseline|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85474|NCT01868035|P1|Participant Flow|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85475|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85476|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85477|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85478|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85479|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85480|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85481|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85482|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85483|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85484|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85485|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85486|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85487|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85488|NCT01868035|E1|Reported Event|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
85489|NCT01868009|B1|Baseline|DISKUS BID in Period 1 or 2; ELLIPTA QD in Period 1 or 2|Participants who were on their current COPD medication(s) were randomized to receive one of the following two sequences of DPIs containing placebo: (1) DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2; (2) ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
85490|NCT01868009|P2|Participant Flow|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
85491|NCT01868009|P1|Participant Flow|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current chronic obstructive pulmonary disease (COPD) medication(s) were randomized to receive DISKUS twice a day (BID) for 5-9 days in Period 1 and ELLIPTA once a day (QD) for 5-9 days in Period 2. There was no washout period between the two periods. Neither dry powder inhaler (DPI) contained any active treatment; placebo was administered in both DPIs.
85492|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
85493|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
85494|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
85495|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
85496|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
85497|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
85498|NCT01868009|E2|Reported Event|DISKUS BID in Period 1 or 2|Subjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period.
85499|NCT01868009|E1|Reported Event|ELLIPTA QD in Period 1 or 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in either Period 1 or Period 2. There was no washout period between the two periods. The DPI did not contain any active treatment; placebo was administered in the DPI.
85500|NCT01867710|B5|Baseline|Total|Total of all reporting groups
85501|NCT01867710|B4|Baseline|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
85502|NCT01867710|B3|Baseline|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
85503|NCT01867710|B2|Baseline|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
85504|NCT01867710|B1|Baseline|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
85573|NCT01867021|P1|Participant Flow|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
85508|NCT01867710|P1|Participant Flow|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
85509|NCT01867710|O4|Outcome|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
85510|NCT01867710|O3|Outcome|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
85511|NCT01867710|O2|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
85512|NCT01867710|O1|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
85513|NCT01867710|O4|Outcome|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
85514|NCT01867710|O3|Outcome|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
85515|NCT01867710|O2|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
85516|NCT01867710|O1|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
85517|NCT01867710|E4|Reported Event|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
85518|NCT01867710|E3|Reported Event|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
85519|NCT01867710|E2|Reported Event|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
85520|NCT01867710|E1|Reported Event|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
85521|NCT01867658|B1|Baseline|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
85522|NCT01867658|P1|Participant Flow|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
85523|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
85524|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
85525|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
85526|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
85527|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
85528|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
85529|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
85530|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
85531|NCT01867658|E1|Reported Event|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
85532|NCT01867632|B3|Baseline|Total|Total of all reporting groups
85533|NCT01867632|B2|Baseline|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
85534|NCT01867632|B1|Baseline|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
85535|NCT01867632|P2|Participant Flow|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
85536|NCT01867632|P1|Participant Flow|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
85537|NCT01867632|O2|Outcome|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
85538|NCT01867632|O1|Outcome|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
85574|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
85539|NCT01867632|O2|Outcome|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
85540|NCT01867632|O1|Outcome|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
85541|NCT01867632|E2|Reported Event|Retrospective Group|Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).
85542|NCT01867632|E1|Reported Event|Prospective Group|Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
85543|NCT01867307|B3|Baseline|Total|Total of all reporting groups
85544|NCT01867307|B2|Baseline|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
85545|NCT01867307|B1|Baseline|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
85546|NCT01867307|P2|Participant Flow|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
85547|NCT01867307|P1|Participant Flow|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
85548|NCT01867307|O2|Outcome|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
85549|NCT01867307|O1|Outcome|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
85550|NCT01867307|E2|Reported Event|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
85551|NCT01867307|E1|Reported Event|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
85552|NCT01867164|B3|Baseline|Total|Total of all reporting groups
85553|NCT01867164|B2|Baseline|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
85554|NCT01867164|B1|Baseline|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
85555|NCT01867164|P2|Participant Flow|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter (mcg/ml) nystatin was administered vaginally, every 24 hours at night, for 10 days.
85556|NCT01867164|P1|Participant Flow|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
85557|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
85558|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
85559|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
85560|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
85561|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
85562|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
85563|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
85564|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
85565|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
85566|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
85567|NCT01867164|E2|Reported Event|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
85568|NCT01867164|E1|Reported Event|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
85569|NCT01867021|B3|Baseline|Total|Total of all reporting groups
85570|NCT01867021|B2|Baseline|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
85571|NCT01867021|B1|Baseline|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
85572|NCT01867021|P2|Participant Flow|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
85576|NCT01867021|O4|Outcome|≥65 years_Fluvirin|Subjects ≥65 years of age who received a control vaccine TIVf
85577|NCT01867021|O3|Outcome|≥65 years_Agriflu|Subjects ≥65 years of age who received an investigational vaccine TIV
85578|NCT01867021|O2|Outcome|≥50 to ≤64 years_Fluvirin|Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf
85579|NCT01867021|O1|Outcome|≥50 to ≤64 years_Agriflu|Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV
85580|NCT01867021|O4|Outcome|≥65 years_Fluvirin|Subjects ≥65 years of age who received a control vaccine TIVf
85581|NCT01867021|O3|Outcome|≥65 years_Agriflu|Subjects ≥65 years of age who received an investigational vaccine TIV
85582|NCT01867021|O2|Outcome|≥50 to ≤64 years_Fluvirin|Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf
85583|NCT01867021|O1|Outcome|≥50 to ≤64 years_Agriflu|Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV
85584|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
85585|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
85586|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
85587|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
85588|NCT01867021|E3|Reported Event|Total|Total number of Subjects
85589|NCT01867021|E2|Reported Event|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
85590|NCT01867021|E1|Reported Event|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
85591|NCT01866709|B3|Baseline|Total|Total of all reporting groups
85592|NCT01866709|B2|Baseline|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.
Silicified microcrystalline cellulose (PLACEBO)
Total Study Enrollment: Assessed for eligibility (n= 36 )
Excluded (n= 4)
Not meeting inclusion criteria (n= 4 )
Declined to participate (n= 0)
Other reasons (n= 0 )
Total Randomized (n= 32 )
Allocated to intervention (n= 17): PLACEBO
Received allocated intervention (n= 17 )
Did not receive allocated intervention (give reasons) (n= 0)
Lost to follow-up (give reasons) (n= 0 )
Discontinued intervention (give reasons) (n= 0)
Analysed (n= 0)
◻ Excluded from analysis (give reasons) (n= 17): study terminated early due to safety reasons"
85593|NCT01866709|B1|Baseline|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.
Sodium polystyrene sulfonate (ACTIVE)
Total Study Enrollment: Assessed for eligibility (n= 36 )
Excluded (n= 4)
Not meeting inclusion criteria (n= 4 )
Declined to participate (n= 0)
Other reasons (n= 0 )
Total Randomized (n= 32 )
Allocated to intervention (n= 15 ): ACTIVE
Received allocated intervention (n= 15)
Did not receive allocated intervention (give reasons) (n= 0 )
Lost to follow-up (give reasons) (n= 0 )
Discontinued intervention before study terminated (n= 1): non-serious adverse event
Analysed (n= 0)
◻ Excluded from analysis (give reasons) (n= 15): study terminated early due to safety reasons"
85594|NCT01866709|P2|Participant Flow|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.
Enrollment: Assessed for eligibility (n= 36 )
Excluded (n= 4)
Not meeting inclusion criteria (n= 4 )
Declined to participate (n= 0)
Other reasons (n= 0 )
Randomized (n= 32 )
Allocated to intervention (n= 17): PLACEBO
Received allocated intervention (n= 17 )
Did not receive allocated intervention (give reasons) (n= 0)
Lost to follow-up (give reasons) (n= 0 )
Analyzed (n= 0)
◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)"
85595|NCT01866709|P1|Participant Flow|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.
Enrollment: Assessed for eligibility (n= 36 )
Excluded (n= 4)
Not meeting inclusion criteria (n= 4 )
Declined to participate (n= 0)
Other reasons (n= 0 )
Randomized (n= 32 )
Allocated to intervention (n= 15 ): ACTIVE
Received allocated intervention (n= 15)
Did not receive allocated intervention (give reasons) (n= 0 )
Lost to follow-up (give reasons) (n= 0 )
Discontinued intervention before study terminated (n= 1): non-serious adverse event
Analyzed (n= 0)
◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)"
85596|NCT01866709|O2|Outcome|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.
Silicified microcrystalline cellulose"
85597|NCT01866709|O1|Outcome|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.
Sodium polystyrene sulfonate"
85598|NCT01866709|O2|Outcome|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.
Silicified microcrystalline cellulose"
85599|NCT01866709|O1|Outcome|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.
Sodium polystyrene sulfonate"
85600|NCT01866709|E2|Reported Event|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.
Silicified microcrystalline cellulose (PLACEBO): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment."
85601|NCT01866709|E1|Reported Event|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.
Sodium polystyrene sulfonate (ACTIVE): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment."
85602|NCT01866423|B1|Baseline|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies"
85603|NCT01866423|P1|Participant Flow|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID (twice a day) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies"
85604|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies"
85605|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies"
85606|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies"
85607|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies"
85608|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies"
85609|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies"
85610|NCT01866423|O1|Outcome|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies"
85611|NCT01866423|E1|Reported Event|Treatment (Orteronel)|"Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies"
85612|NCT01866319|B4|Baseline|Total|Total of all reporting groups
85613|NCT01866319|B3|Baseline|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
85614|NCT01866319|B2|Baseline|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
85615|NCT01866319|B1|Baseline|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
85616|NCT01866319|P3|Participant Flow|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
85617|NCT01866319|P2|Participant Flow|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to 2 years
85618|NCT01866319|P1|Participant Flow|Ipilimumab|Participants receive ipilimumab, 3 mg/kg intravenously (IV), once eveery 3 weeks (Q3W) for a total of 4 doses
85619|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
85620|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
85621|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
85622|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
85623|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
85624|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
85625|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
85626|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
85627|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
85628|NCT01866319|E3|Reported Event|Pembrolizumab 10 mg/kg Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
85629|NCT01866319|E2|Reported Event|Pembrolizumab 10 mg/kg Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
85630|NCT01866319|E1|Reported Event|Ipilimumab 3 mg/kg Q3W|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
85631|NCT01866306|B8|Baseline|Total|Total of all reporting groups
85632|NCT01866306|B7|Baseline|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85633|NCT01866306|B6|Baseline|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85634|NCT01866306|B5|Baseline|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85635|NCT01866306|B4|Baseline|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85636|NCT01866306|B3|Baseline|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85637|NCT01866306|B2|Baseline|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85638|NCT01866306|B1|Baseline|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85639|NCT01866306|P7|Participant Flow|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85640|NCT01866306|P6|Participant Flow|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85792|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
85793|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
85641|NCT01866306|P5|Participant Flow|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85642|NCT01866306|P4|Participant Flow|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85643|NCT01866306|P3|Participant Flow|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85644|NCT01866306|P2|Participant Flow|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85645|NCT01866306|P1|Participant Flow|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85646|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85647|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85648|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85649|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85650|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85651|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85652|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85653|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85654|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85655|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85656|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85657|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85658|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85659|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85660|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85661|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85662|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85663|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85664|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85665|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85666|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85667|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85668|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85669|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85794|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
85670|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85671|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85672|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85673|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85732|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
85733|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
85674|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85675|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85676|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85677|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85678|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85679|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85680|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85681|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85682|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85683|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85684|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85685|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85686|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85687|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85688|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85689|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85690|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85691|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85692|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85693|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85694|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85695|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85696|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85697|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85795|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
85796|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
85698|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85699|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85700|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85701|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85702|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85734|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
85703|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85704|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85705|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85706|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85707|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85708|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85709|NCT01866306|E7|Reported Event|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85710|NCT01866306|E6|Reported Event|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85711|NCT01866306|E5|Reported Event|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85712|NCT01866306|E4|Reported Event|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85713|NCT01866306|E3|Reported Event|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85714|NCT01866306|E2|Reported Event|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85715|NCT01866306|E1|Reported Event|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
85716|NCT01866293|B1|Baseline|Cabozantinib (XL184)|"Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
Cabozantinib (XL184)"
85717|NCT01866293|P1|Participant Flow|Cabozantinib (XL184)|"Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
Cabozantinib (XL184)"
85718|NCT01866293|O1|Outcome|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
85719|NCT01866293|O1|Outcome|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
85720|NCT01866293|O1|Outcome|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
85721|NCT01866293|O1|Outcome|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
85722|NCT01866293|O1|Outcome|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
85723|NCT01866293|E1|Reported Event|Cabozantinib (XL184)|Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
85724|NCT01866163|B3|Baseline|Total|Total of all reporting groups
85725|NCT01866163|B2|Baseline|Vehicle|Aerosol foam vehicle
85726|NCT01866163|B1|Baseline|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
85727|NCT01866163|P2|Participant Flow|Vehicle|Aerosol foam vehicle
85728|NCT01866163|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
85729|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
85730|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
85731|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
85736|NCT01866163|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
85737|NCT01866150|B1|Baseline|Overall Population|Retrospective chart review of all participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to NICE guidelines. Biologic combination therapy included biologic drug therapy (any) plus MTX or biologic plus MTX plus any other and classical DMARDs.
85738|NCT01866150|P1|Participant Flow|Overall Population|Retrospective chart review of all participants with rheumatoid arthritis (RA) who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to National Institute for Health and Care Excellence (NICE) guidelines. Biologic combination therapy included biologic drug therapy (any) plus methotrexate (MTX) or biologic plus MTX plus any other and classical disease-modifying antirheumatic drugs (DMARDs).
85739|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
85740|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
85741|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
85742|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
85743|NCT01866150|O1|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
85744|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
85745|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
85746|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
85747|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
85748|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
85749|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
85750|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
85751|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
85752|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
85753|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
85754|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
85755|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
85756|NCT01866150|E2|Reported Event|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
85757|NCT01866150|E1|Reported Event|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) as monotherapy according to NICE guidelines.
85797|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
85798|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
85799|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
85758|NCT01865812|B1|Baseline|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks
obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
85759|NCT01865812|P1|Participant Flow|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks
obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
85806|NCT01865084|E2|Reported Event|0.3 mg/kg Tadalafil -DB|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
85807|NCT01865084|E1|Reported Event|Placebo - DB|Placebo taken orally once daily.
85808|NCT01864538|B1|Baseline|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
85760|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks
obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
85761|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks
obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
85762|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks
obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
85763|NCT01865812|E1|Reported Event|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks
obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
85764|NCT01865747|B3|Baseline|Total|Total of all reporting groups
85765|NCT01865747|B2|Baseline|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.
Everolimus (Afinitor) tablets"
85766|NCT01865747|B1|Baseline|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.
Cabozantinib tablets"
85767|NCT01865747|P2|Participant Flow|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.
Everolimus (Afinitor) tablets"
85768|NCT01865747|P1|Participant Flow|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.
Cabozantinib tablets"
85769|NCT01865747|O2|Outcome|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.
Everolimus (Afinitor) tablets"
85770|NCT01865747|O1|Outcome|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.
Cabozantinib tablets"
85771|NCT01865747|O2|Outcome|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.
Everolimus (Afinitor) tablets"
85772|NCT01865747|O1|Outcome|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.
Cabozantinib tablets"
85773|NCT01865747|O2|Outcome|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.
Everolimus (Afinitor) tablets"
85774|NCT01865747|O1|Outcome|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.
Cabozantinib tablets"
85775|NCT01865747|E2|Reported Event|Everolimus (Afinitor)|"Everolimus (Afinitor) 10 mg tablet once daily.
Everolimus (Afinitor) tablets"
85776|NCT01865747|E1|Reported Event|Cabozantinib (XL184)|"Cabozantinib (XL184) 60 mg tablet once daily.
Cabozantinib tablets"
85777|NCT01865084|B4|Baseline|Total|Total of all reporting groups
85778|NCT01865084|B3|Baseline|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
85779|NCT01865084|B2|Baseline|0.3 mg/kg Tadalafil|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
85780|NCT01865084|B1|Baseline|Placebo|Placebo taken orally once daily.
85781|NCT01865084|P3|Participant Flow|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
85782|NCT01865084|P2|Participant Flow|0.3 mg/kg Tadalafil|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
85783|NCT01865084|P1|Participant Flow|Placebo|Placebo taken orally once daily.
85784|NCT01865084|O1|Outcome|0.3 mg/kg Tadalafil and 0.6 mg/kg Tadalafil|"0.3 mg/kg tadalafil taken orally once daily.
0.6 mg/kg tadalafil taken orally once daily."
85785|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
85786|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
85787|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
85788|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
85789|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
85790|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
85791|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
85800|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg taken tadalafil orally once daily.
85801|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
85802|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
85803|NCT01865084|E5|Reported Event|0.6 mg/kg Tadalafil - OLE|0.6 mg/kg tadalafil taken orally once daily.
85804|NCT01865084|E4|Reported Event|0.3 mg/kg Tadalafil - OLE|0.3 mg/kg tadalafil taken orally once daily.
85805|NCT01865084|E3|Reported Event|0.6 mg/kg Tadalafil - DB|0.6 mg/kg tadalafil taken orally once daily.
85809|NCT01864538|P1|Participant Flow|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
85810|NCT01864538|O1|Outcome|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
85811|NCT01864538|E1|Reported Event|TH-302|"480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
TH-302: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle."
85812|NCT01864434|B3|Baseline|Total|Total of all reporting groups
85813|NCT01864434|B2|Baseline|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.
Zimmer PCR TKA"
85814|NCT01864434|B1|Baseline|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.
Stryker PCR TKA"
85815|NCT01864434|P2|Participant Flow|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.
Zimmer PCR TKA"
85816|NCT01864434|P1|Participant Flow|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.
Stryker PCR TKA"
85817|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.
Zimmer PCR TKA"
85818|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.
Stryker PCR TKA"
85819|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.
Zimmer PCR TKA"
85820|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.
Stryker PCR TKA"
85821|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.
Zimmer PCR TKA"
85822|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.
Stryker PCR TKA"
85823|NCT01864434|E2|Reported Event|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.
Zimmer PCR TKA"
85824|NCT01864434|E1|Reported Event|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.
Stryker PCR TKA"
85825|NCT01864174|B3|Baseline|Total|Total of all reporting groups
85826|NCT01864174|B2|Baseline|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.
Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85827|NCT01864174|B1|Baseline|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR
Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85828|NCT01864174|P2|Participant Flow|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.
Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85829|NCT01864174|P1|Participant Flow|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR
Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85830|NCT01864174|O2|Outcome|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.
Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85831|NCT01864174|O1|Outcome|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR
Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85832|NCT01864174|O2|Outcome|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.
Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85833|NCT01864174|O1|Outcome|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR
Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85834|NCT01864174|O2|Outcome|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.
Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85835|NCT01864174|O1|Outcome|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR
Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85836|NCT01864174|O2|Outcome|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.
Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85876|NCT01864148|E2|Reported Event|BIIB033 3 mg/kg|BIIB033 3 mg/kg once every 4 weeks IV infusion
85837|NCT01864174|O1|Outcome|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR
Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85838|NCT01864174|O2|Outcome|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.
Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85903|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
85839|NCT01864174|O1|Outcome|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR
Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85840|NCT01864174|E2|Reported Event|Metformin IR|"Participants received Metformin IR and Placebo matching with Metformin IR.
Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85841|NCT01864174|E1|Reported Event|Metformin XR|"Participants received Metformin XR and Placebo matching with Metformin XR
Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks."
85842|NCT01864148|B6|Baseline|Total|Total of all reporting groups
85843|NCT01864148|B5|Baseline|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85844|NCT01864148|B4|Baseline|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85845|NCT01864148|B3|Baseline|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85846|NCT01864148|B2|Baseline|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85847|NCT01864148|B1|Baseline|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85848|NCT01864148|P5|Participant Flow|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85849|NCT01864148|P4|Participant Flow|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85850|NCT01864148|P3|Participant Flow|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85851|NCT01864148|P2|Participant Flow|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85852|NCT01864148|P1|Participant Flow|Placebo|"Placebo once every 4 weeks intravenous (IV) infusion up to Week 72.
Avonex once-weekly intramuscular (IM) injection up to Week 84."
85853|NCT01864148|O4|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85854|NCT01864148|O3|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85855|NCT01864148|O2|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85856|NCT01864148|O1|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85857|NCT01864148|O6|Outcome|BIIB033 Total|BIIB033 3, 10, 30, or 100 mg/kg once every 4 weeks IV infusion
85858|NCT01864148|O5|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85859|NCT01864148|O4|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85860|NCT01864148|O3|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85861|NCT01864148|O2|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85862|NCT01864148|O1|Outcome|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85863|NCT01864148|O5|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85864|NCT01864148|O4|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85865|NCT01864148|O3|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85866|NCT01864148|O2|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85867|NCT01864148|O1|Outcome|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85868|NCT01864148|O5|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85869|NCT01864148|O4|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85870|NCT01864148|O3|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85871|NCT01864148|O2|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85872|NCT01864148|O1|Outcome|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85873|NCT01864148|E5|Reported Event|BIIB033 100 mg/kg|BIIB033 100 mg/kg once every 4 weeks IV infusion
85874|NCT01864148|E4|Reported Event|BIIB033 30 mg/kg|BIIB033 30 mg/kg once every 4 weeks IV infusion
85875|NCT01864148|E3|Reported Event|BIIB033 10 mg/kg|BIIB033 10 mg/kg once every 4 weeks IV infusion
85877|NCT01864148|E1|Reported Event|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84."
85878|NCT01864005|B3|Baseline|Total|Total of all reporting groups
85879|NCT01864005|B2|Baseline|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
85904|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
85880|NCT01864005|B1|Baseline|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
85881|NCT01864005|P2|Participant Flow|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
85882|NCT01864005|P1|Participant Flow|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
85883|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
85884|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
85885|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
85886|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
85887|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
85888|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
85889|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
85890|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
85891|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
85892|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
85893|NCT01864005|E2|Reported Event|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
85894|NCT01864005|E1|Reported Event|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
85895|NCT01863953|B4|Baseline|Total|Total of all reporting groups
85896|NCT01863953|B3|Baseline|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
85897|NCT01863953|B2|Baseline|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
85898|NCT01863953|B1|Baseline|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
86053|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
85899|NCT01863953|P3|Participant Flow|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
85900|NCT01863953|P2|Participant Flow|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
85901|NCT01863953|P1|Participant Flow|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
85902|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
88038|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
85905|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
85906|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
85907|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
85908|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
85909|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
85910|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
85911|NCT01863953|E3|Reported Event|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
85912|NCT01863953|E2|Reported Event|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
85913|NCT01863953|E1|Reported Event|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
85914|NCT01863771|B1|Baseline|All Participants|Participants who received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC) in the induction phase.
85915|NCT01863771|P4|Participant Flow|Group 4: Golimumab 100 mg [Maintenance]|Participants who not responded to golimumab induction dosing received golimumab 100 mg SC once at Week 0 and once at Week 4, and based on clinical response every 4 weeks through Week 52.
85916|NCT01863771|P3|Participant Flow|Group 3: Placebo [Maintenance]|Participants who responded to golimumab induction treatment received placebo SC every 4 weeks (q4w) through Week 52.
85917|NCT01863771|P2|Participant Flow|Group 2: Golimumab 100 mg [Maintenance]|Participants who responded to golimumab induction treatment received golimumab 100 mg SC every 4 weeks (q4w) through Week 52.
85918|NCT01863771|P1|Participant Flow|Group1: Golimumab [Induction]|Participants received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC).
85919|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
85920|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
85921|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
85922|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
85923|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
85924|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
85925|NCT01863771|E4|Reported Event|Group 4: Golimumab 100 mg [Maintenance]|Participants who not responded to golimumab induction dosing received golimumab 100 mg SC once at Week 0 and once at Week 4, and based on clinical response every 4 week through Week 52.
85926|NCT01863771|E3|Reported Event|Group 3: Placebo [Maintenance]|Participants who responded to golimumab induction treatment received placebo SC every 4 weeks (q4w) through Week 52.
85927|NCT01863771|E2|Reported Event|Group 2: Golimumab 100 mg [Maintenance]|Participants who responded to golimumab induction treatment received golimumab 100 mg SC every 4 weeks (q4w) through Week 52.
85928|NCT01863771|E1|Reported Event|Group1: Golimumab [Induction]|Participants received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC).
85929|NCT01863680|B1|Baseline|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.
Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro fertilization and embryo transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
86056|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
85930|NCT01863680|P1|Participant Flow|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.
Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using Gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
85959|NCT01863433|P1|Participant Flow|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
85931|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.
Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
85932|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.
Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
85933|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.
Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
85934|NCT01863680|E1|Reported Event|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.
Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
85935|NCT01863667|B3|Baseline|Total|Total of all reporting groups
85936|NCT01863667|B2|Baseline|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
85937|NCT01863667|B1|Baseline|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
85938|NCT01863667|P2|Participant Flow|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
85939|NCT01863667|P1|Participant Flow|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
85940|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
85941|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
85942|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
85943|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
85944|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
85945|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
85946|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
85947|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
85948|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
85949|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
85950|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
85951|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
85952|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
85953|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
88389|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
85954|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
85955|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
85956|NCT01863667|E2|Reported Event|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
85957|NCT01863667|E1|Reported Event|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
85958|NCT01863433|B1|Baseline|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
85960|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
85961|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
85962|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
85963|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
85964|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
85965|NCT01863433|E1|Reported Event|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
85966|NCT01863368|B3|Baseline|Total|Total of all reporting groups
85967|NCT01863368|B2|Baseline|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85968|NCT01863368|B1|Baseline|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85969|NCT01863368|P2|Participant Flow|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85970|NCT01863368|P1|Participant Flow|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85971|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85972|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85973|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85974|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85975|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85976|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85977|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85978|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
85979|NCT01863368|E3|Reported Event|Optive|All subjects who were exposed to Optive or run-in therapy
85980|NCT01863368|E2|Reported Event|Systane Ultra|All subjects who were exposed to Systane Ultra or run-in therapy
85981|NCT01863368|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
85982|NCT01863134|B3|Baseline|Total|Total of all reporting groups
85983|NCT01863134|B2|Baseline|Eptifibatide|In the treatment group patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery). The minimal and maximal periods of eptifibatide infusion were established at 12 and 48 hours respectively.
85984|NCT01863134|B1|Baseline|Placebo/Control Group|In the control group patients were given identical doses of acetylsalicylic acid and enoxaparin followed by a placebo infusion of saline in lieu of the GPIIb/IIIa inhibitor.
85985|NCT01863134|P2|Participant Flow|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
85986|NCT01863134|P1|Participant Flow|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
85987|NCT01863134|O2|Outcome|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
85988|NCT01863134|O1|Outcome|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
86054|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
85989|NCT01863134|E2|Reported Event|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
85990|NCT01863134|E1|Reported Event|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
85991|NCT01862991|B4|Baseline|Total|Total of all reporting groups
85992|NCT01862991|B3|Baseline|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally"
85993|NCT01862991|B2|Baseline|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally"
85994|NCT01862991|B1|Baseline|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
85995|NCT01862991|P3|Participant Flow|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally"
85996|NCT01862991|P2|Participant Flow|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally"
85997|NCT01862991|P1|Participant Flow|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
85998|NCT01862991|O3|Outcome|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally"
85999|NCT01862991|O2|Outcome|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally"
86000|NCT01862991|O1|Outcome|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
86001|NCT01862991|O3|Outcome|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally"
86002|NCT01862991|O2|Outcome|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally"
86055|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
86003|NCT01862991|O1|Outcome|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
86004|NCT01862991|E3|Reported Event|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally"
86064|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
86065|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
86005|NCT01862991|E2|Reported Event|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally"
86006|NCT01862991|E1|Reported Event|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
86007|NCT01862484|B3|Baseline|Total|Total of all reporting groups
86008|NCT01862484|B2|Baseline|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.
Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
86009|NCT01862484|B1|Baseline|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.
Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
86010|NCT01862484|P2|Participant Flow|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.
Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
86011|NCT01862484|P1|Participant Flow|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.
Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
86012|NCT01862484|O2|Outcome|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.
Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
86013|NCT01862484|O1|Outcome|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.
Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
86014|NCT01862484|E2|Reported Event|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.
Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
86015|NCT01862484|E1|Reported Event|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.
Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
86016|NCT01862419|B3|Baseline|Total|Total of all reporting groups
86017|NCT01862419|B2|Baseline|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
86018|NCT01862419|B1|Baseline|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
86019|NCT01862419|P2|Participant Flow|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
86020|NCT01862419|P1|Participant Flow|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
86021|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
86022|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
86023|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
86024|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
86025|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
86026|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
86027|NCT01862419|E2|Reported Event|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
86028|NCT01862419|E1|Reported Event|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
86029|NCT01862159|B1|Baseline|Operated Patients|All patients operated with a laparoscopic gastric bypass procedure in Sweden during the inclusion period.
86030|NCT01862159|P1|Participant Flow|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012
laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
86031|NCT01862159|O1|Outcome|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012
laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
86032|NCT01862159|O1|Outcome|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012
laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
86033|NCT01862159|O1|Outcome|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012
laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
86034|NCT01862159|O1|Outcome|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012
laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
86066|NCT01861925|E3|Reported Event|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
86035|NCT01862159|E1|Reported Event|Operated Patients|"Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012
laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery"
86036|NCT01862133|B1|Baseline|Patient Preferences|Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
86037|NCT01862133|P2|Participant Flow|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.
Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.
11 physicians and 23 additional clinic staff (5 nurses, 4 clinical nurse assistants, 3 physicians' assistants, 2 nurse practitioners, and 9 medical assistance worked in the study primary care clinic at the time of the study
2 physicians were excluded because their patients were mainly Spanish speaking
1 physician verbally agreed to be in the study but never signed the informed consent statement
8 physicians and all 23 of the other clinic staff were enrolled and signed informed consent statements and completed in the study"
86038|NCT01862133|P1|Participant Flow|Patient Preferences|"Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
141 adult primary care clinic patients were approached 38 refused to participate 107 were enrolled and signed informed consent statements 2 failed to complete the patient preference dialog and study questionnaire 105 completed the patient preference dialog and were included in the study 92 subjects returned to the clinic during the 6-month study"
86039|NCT01862133|O2|Outcome|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.
Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.
11 physicians and 23 additional clinic staff (5 nurses, 4 clinical nurse assistants, 3 physicians' assistants, 2 nurse practitioners, and 9 medical assistance worked in the study primary care clinic at the time of the study
2 physicians were excluded because their patients were mainly Spanish speaking
1 physician verbally agreed to be in the study but never signed the informed consent statement
8 physicians and all 23 of the other clinic staff were enrolled and signed informed consent statements and completed in the study
24"
86040|NCT01862133|O1|Outcome|Patient Preferences|"Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
141 adult primary care clinic patients were approached 38 refused to participate 107 were enrolled and signed informed consent statements 2 failed to complete the patient preference dialog and study questionnaire 105 completed the patient preference dialog and were included in the study 92 subjects returned to the clinic during the 6-month study"
86041|NCT01862133|E2|Reported Event|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.
Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences."
86042|NCT01862133|E1|Reported Event|Patient Preferences|Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
86043|NCT01861925|B4|Baseline|Total|Total of all reporting groups
86044|NCT01861925|B3|Baseline|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
86045|NCT01861925|B2|Baseline|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
86046|NCT01861925|B1|Baseline|Normal Eye|Astigmatism smaller than 1.5 diopters
86047|NCT01861925|P3|Participant Flow|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
86048|NCT01861925|P2|Participant Flow|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
86049|NCT01861925|P1|Participant Flow|Normal Eye|Astigmatism smaller than 1.5 diopters
86050|NCT01861925|O1|Outcome|Regular Eye|"Astigmatism smaller than 1.5 diopters and regular astigmatism >= 1.5 diopters (group normal eye and large regular astigmatism)"
86051|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
86052|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
86057|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
86058|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
86059|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
86060|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
86061|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
86062|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
86063|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
86067|NCT01861925|E2|Reported Event|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
86068|NCT01861925|E1|Reported Event|Normal Eye|Astigmatism smaller than 1.5 diopters
86069|NCT01861756|B3|Baseline|Total|Total of all reporting groups
86070|NCT01861756|B2|Baseline|Usual Care|
86071|NCT01861756|B1|Baseline|Diabetes Medication Choice Decision Aid|
86072|NCT01861756|P2|Participant Flow|Usual Care|
86073|NCT01861756|P1|Participant Flow|Diabetes Medication Choice Decision Aid|
86074|NCT01861756|O2|Outcome|Usual Care|
86075|NCT01861756|O1|Outcome|Diabetes Medication Choice Decision Aid|
86076|NCT01861756|E2|Reported Event|Usual Care|
86077|NCT01861756|E1|Reported Event|Diabetes Medication Choice Decision Aid|
86078|NCT01861704|B3|Baseline|Total|Total of all reporting groups
86079|NCT01861704|B2|Baseline|Lyric2|"Lyric2 (Barracuda) device
Lyric: Extended wear hearing instrument"
86080|NCT01861704|B1|Baseline|Lyric|"Silver Lyric device
Lyric: Extended wear hearing instrument"
86081|NCT01861704|P2|Participant Flow|Lyric2|"Lyric2 (Barracuda) device
Lyric: Extended wear hearing instrument"
86082|NCT01861704|P1|Participant Flow|Lyric|"Silver Lyric device
Lyric: Extended wear hearing instrument"
86083|NCT01861704|O2|Outcome|Lyric2|"Lyric2 (Barracuda) device
Lyric: Extended wear hearing instrument
Only experienced ears counted"
86084|NCT01861704|O1|Outcome|Lyric|"Silver Lyric device
Lyric: Extended wear hearing instrument
Only experienced ears counted"
86085|NCT01861704|E2|Reported Event|Lyric2|"Lyric2 (Barracuda) device
Lyric: Extended wear hearing instrument"
86086|NCT01861704|E1|Reported Event|Lyric|"Silver Lyric device
Lyric: Extended wear hearing instrument"
86087|NCT01861522|B3|Baseline|Total|Total of all reporting groups
86088|NCT01861522|B2|Baseline|Placebo|TAU-284 placebo twice daily for 2 weeks
86089|NCT01861522|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 2 weeks
86090|NCT01861522|P2|Participant Flow|Placebo|TAU-284 placebo twice daily for 2 weeks
86091|NCT01861522|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 2 weeks
86092|NCT01861522|O2|Outcome|Placebo|TAU-284 placebo twice daily for 2 weeks
86093|NCT01861522|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
86094|NCT01861522|E2|Reported Event|Placebo|TAU-284 placebo twice daily for 2 weeks
86095|NCT01861522|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 2 weeks
86096|NCT01861457|B3|Baseline|Total|Total of all reporting groups
86097|NCT01861457|B2|Baseline|Saline Placebo|"Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.
Placebo"
86098|NCT01861457|B1|Baseline|Nozin Nasal Sanitizer|"Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.
Nozin Nasal Sanitizer"
86099|NCT01861457|P2|Participant Flow|Phosphate-buffered Saline (PBS) Placebo|Participants undergo three nasal vestibular applications of the PBS placebo using a saturated nasal swab at 4-hour intervals during the 10-hour study period.
86100|NCT01861457|P1|Participant Flow|Nozin® Nasal Sanitizer®|Participants undergo three nasal vestibular applications of the alcohol-based antiseptic using a saturated nasal swab at 4-hour intervals during the 10-hour study period.
86101|NCT01861457|O2|Outcome|Placebo|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.
86102|NCT01861457|O1|Outcome|Alcohol-Based Nasal Antiseptic|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.
86103|NCT01861457|O2|Outcome|Placebo|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.
86104|NCT01861457|O1|Outcome|Alcohol-Based Nasal Antiseptic|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.
86105|NCT01861457|E2|Reported Event|Sham|"Apply 4 rotations of swab to each nostril every four hours ...
Sham"
86106|NCT01861457|E1|Reported Event|Nozin Nasal Sanitizer|"Apply 4 rotations of swab to each nostril every four hours
Nozin Nasal Sanitizer"
86107|NCT01861301|B1|Baseline|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
86108|NCT01861301|P1|Participant Flow|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
86109|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
86110|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
86111|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
86112|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
86113|NCT01861301|E1|Reported Event|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
86114|NCT01860989|B1|Baseline|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
86115|NCT01860989|P1|Participant Flow|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
86116|NCT01860989|O1|Outcome|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
86117|NCT01860989|E1|Reported Event|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
86118|NCT01860976|B3|Baseline|Total|Total of all reporting groups
86119|NCT01860976|B2|Baseline|Placebo|Placebo, self-administered subcutaneously, once weekly.
86122|NCT01860976|P1|Participant Flow|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
86123|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
86124|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
86125|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
86126|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
86127|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
86128|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
86129|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
86130|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
86131|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
86132|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
86133|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
86134|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
86135|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
86136|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
86137|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
86138|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
86139|NCT01860976|O2|Outcome|Placebo|Placebo, self-administered subcutaneously, once weekly.
86140|NCT01860976|O1|Outcome|Abatacept|Abatacept 125mg, self-administered subcutaneously, once weekly
86141|NCT01860976|E2|Reported Event|PLACEBO|
86142|NCT01860976|E1|Reported Event|SC ABATACEPT|
86143|NCT01860846|B1|Baseline|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
86144|NCT01860846|P1|Participant Flow|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
86145|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
86146|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
86147|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
86148|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
86149|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
86150|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
86151|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
86152|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
86153|NCT01860846|E1|Reported Event|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
86154|NCT01860703|B1|Baseline|All Subjects|Subjects in this cross-over study all received one dose of each the following: A) a maximum therapeutic dose of 33 mg deferiprone, B) a supratherapeutic dose of 50 mg/kg deferiprone, C) placebo, and D) moxifloxacin (active control). They were randomized to receive these products in different orders: ABCD, BDAC, CADB, or DCBA. Treatments were separated by a 7-day washout period.
86155|NCT01860703|P4|Participant Flow|DCBA|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment D = single oral dose of moxifloxacin Treatment C = single oral dose of placebo Treatment B = single oral dose of 50 mg/kg deferiprone Treatment A = single oral dose of 33 mg/kg deferiprone"
86156|NCT01860703|P3|Participant Flow|CADB|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment C = single oral dose of placebo Treatment A = single oral dose of 33 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment B = single oral dose of 50 mg/kg deferiprone"
86157|NCT01860703|P2|Participant Flow|BDAC|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment B = single oral dose of 50 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment A = single oral dose of 33 mg/kg deferiprone Treatment C = single oral dose of placebo"
86221|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
Amino acids"
86158|NCT01860703|P1|Participant Flow|ABCD|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:
Treatment A = single oral dose of 33 mg/kg deferiprone Treatment B = single oral dose of 50 mg/kg deferiprone Treatment C = single oral dose of placebo Treatment D = single oral dose of moxifloxacin"
86159|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86160|NCT01860703|O1|Outcome|Positive Control|A single 400 mg tablet of moxifloxacin. The tablet was administered orally with approximately 240 mL of water.
88535|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
86161|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
86162|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86163|NCT01860703|O2|Outcome|Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86164|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86165|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
86166|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86167|NCT01860703|O2|Outcome|Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86168|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86169|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86170|NCT01860703|O1|Outcome|50 mg/kg Deferiprone|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86171|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86172|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86173|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86174|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86175|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86176|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86177|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86222|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
Amino acids"
86223|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
Amino acids"
86178|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86179|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
86180|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86298|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86181|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86182|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86183|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86184|NCT01860703|O1|Outcome|33 mg/kg Deferiprone|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
86185|NCT01860703|E4|Reported Event|Treatment Arm D - Positive Control|"Single dose of deferiprone matching placebo tablets and one 400 mg moxifloxacin tablet.
Deferiprone
moxifloxacin"
86186|NCT01860703|E3|Reported Event|Treatment Arm C - Placebo Control|"Single dose of deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.
deferiprone matching placebo tablets
moxifloxacin matching placebo tablet"
86187|NCT01860703|E2|Reported Event|Treatment Arm B - Supratherapeutic Dose|"Single dose of 50 mg/kg rounded to the nearest 250 mg of deferiprone tablets, and one moxifloxacin matching placebo tablet.
Deferiprone
moxifloxacin matching placebo tablet"
86188|NCT01860703|E1|Reported Event|Treatment Arm A - Maximum Therapeutic Dose|"Single dose of 33 mg/kg rounded to the nearest 250 mg of deferiprone tablets, deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.
Deferiprone
deferiprone matching placebo tablets
moxifloxacin matching placebo tablet"
86189|NCT01860677|B1|Baseline|All Study Participants|All of the study participants
86190|NCT01860677|P2|Participant Flow|Sham First, Then Active|"Sham first, then Active treatment
Active:
The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.
Fisher Wallace Cranial Stimulator
Sham:
Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.
Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
86191|NCT01860677|P1|Participant Flow|Active First, Then Sham|"Active treatment first, then Sham
Active:
The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.
Fisher Wallace Cranial Stimulator
Sham:
Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.
Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
86192|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.
Fisher Wallace Cranial Stimulator"
86193|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.
Fisher Wallace Cranial Stimulator"
86224|NCT01860573|E2|Reported Event|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
Amino acids"
86225|NCT01860573|E1|Reported Event|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
Amino acids"
86226|NCT01860534|B3|Baseline|Total|Total of all reporting groups
86194|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.
Fisher Wallace Cranial Stimulator"
86195|NCT01860677|O2|Outcome|Sham Stimulation|"Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.
Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
86196|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.
Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
86197|NCT01860677|E2|Reported Event|Sham Stimulation|Participants are outfitted with a device that is identical in appearance but does not deliver any current.
86198|NCT01860677|E1|Reported Event|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.
Fisher Wallace Cranial Stimulator"
86199|NCT01860586|B1|Baseline|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)
Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
86200|NCT01860586|P1|Participant Flow|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)
Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
86201|NCT01860586|O1|Outcome|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)
Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
86202|NCT01860586|O1|Outcome|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)
Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
86203|NCT01860586|O1|Outcome|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)
Bevacizumab: .005 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
86204|NCT01860586|E1|Reported Event|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)
Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
86205|NCT01860573|B3|Baseline|Total|Total of all reporting groups
86206|NCT01860573|B2|Baseline|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
Amino acids"
86207|NCT01860573|B1|Baseline|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
Amino acids"
86208|NCT01860573|P2|Participant Flow|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
Amino acids"
86209|NCT01860573|P1|Participant Flow|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
Amino acids"
86210|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
Amino acids"
86211|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
Amino acids"
86212|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
Amino acids"
86213|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
Amino acids"
86214|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
Amino acids"
86215|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
Amino acids"
86216|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
Amino acids"
86217|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
Amino acids"
86218|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
Amino acids"
86219|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
Amino acids"
86220|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
Amino acids"
86227|NCT01860534|B2|Baseline|no Eye Patches Initially Then Eye Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
86303|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86228|NCT01860534|B1|Baseline|Eye Patches Initially Then no Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
86229|NCT01860534|P2|Participant Flow|no Eye Patches Initially Then Eye Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
86230|NCT01860534|P1|Participant Flow|Eye Patch Initially Then no Eye Patch|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
86231|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
86232|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
86233|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
86234|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
86235|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
86236|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
87583|NCT01854645|B4|Baseline|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
86237|NCT01860534|O2|Outcome|no Eye Patches Covers (ROP #1 and ROP #2)|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
86386|NCT01859988|E1|Reported Event|Dupilumab 300 mg qw|Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86238|NCT01860534|O1|Outcome|Eye Patches Covers (ROP #1 and ROP #2)|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
86239|NCT01860534|E2|Reported Event|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
86240|NCT01860534|E1|Reported Event|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
86241|NCT01860521|B3|Baseline|Total|Total of all reporting groups
86242|NCT01860521|B2|Baseline|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86243|NCT01860521|B1|Baseline|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86244|NCT01860521|P2|Participant Flow|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86245|NCT01860521|P1|Participant Flow|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86246|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86289|NCT01859988|B2|Baseline|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86247|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86299|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86387|NCT01859949|B3|Baseline|Total|Total of all reporting groups
86388|NCT01859949|B2|Baseline|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
86248|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86249|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86250|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86251|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86252|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86253|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86254|NCT01860521|E2|Reported Event|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86290|NCT01859988|B1|Baseline|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86291|NCT01859988|P6|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86424|NCT01859715|P2|Participant Flow|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
86255|NCT01860521|E1|Reported Event|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.
Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
86256|NCT01860170|B4|Baseline|Total|Total of all reporting groups
86257|NCT01860170|B3|Baseline|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86389|NCT01859949|B1|Baseline|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
86258|NCT01860170|B2|Baseline|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86259|NCT01860170|B1|Baseline|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86260|NCT01860170|P3|Participant Flow|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86261|NCT01860170|P2|Participant Flow|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86262|NCT01860170|P1|Participant Flow|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86263|NCT01860170|O3|Outcome|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86324|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86264|NCT01860170|O2|Outcome|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86265|NCT01860170|O1|Outcome|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86300|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86390|NCT01859949|P2|Participant Flow|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
86266|NCT01860170|O3|Outcome|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86267|NCT01860170|O2|Outcome|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86268|NCT01860170|O1|Outcome|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86269|NCT01860170|O3|Outcome|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86270|NCT01860170|O2|Outcome|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86271|NCT01860170|O1|Outcome|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86272|NCT01860170|E3|Reported Event|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86273|NCT01860170|E2|Reported Event|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86301|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86302|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86274|NCT01860170|E1|Reported Event|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
86275|NCT01860079|B3|Baseline|Total|Total of all reporting groups
86276|NCT01860079|B2|Baseline|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure
86277|NCT01860079|B1|Baseline|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours."
86278|NCT01860079|P2|Participant Flow|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure.
86279|NCT01860079|P1|Participant Flow|Early Discharge Group|In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
86280|NCT01860079|O2|Outcome|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure
86281|NCT01860079|O1|Outcome|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours."
86282|NCT01860079|E2|Reported Event|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure. During the two year study period, 900 PPCI patients arrived at the three different study centers. After the exclusion of 131 patients due to primary exclusion criteria 769 patients were randomized in to two groups. There were 385 patients in the standard discharge group. Sixteen patients were excluded due to primary exclusion criteria such as signs of heart failure (n=7, %), clinically significant arrhythmia requiring treatment (n=3, %), chest pain recurrence (n=4,%), cardiogenic shock (n=1,%). Furthermore, a total of 6 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 363 patients in the standard discharge group.
86283|NCT01860079|E1|Reported Event|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
During 2 year study period, 900 PPCI patients arrived at the three different study centers. 769 patients were randomized in to two groups. There were 384 patients in the early discharge arm. Four patients were excluded due to social repatriation reasons. Furthermore, a total of 10 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 370 patients in the early discharge group."
86284|NCT01859988|B7|Baseline|Total|Total of all reporting groups
86285|NCT01859988|B6|Baseline|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86286|NCT01859988|B5|Baseline|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86287|NCT01859988|B4|Baseline|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86288|NCT01859988|B3|Baseline|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86421|NCT01859715|B2|Baseline|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
86292|NCT01859988|P5|Participant Flow|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86293|NCT01859988|P4|Participant Flow|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab every 4 weeks (q4w) and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86294|NCT01859988|P3|Participant Flow|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86295|NCT01859988|P2|Participant Flow|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15.
86296|NCT01859988|P1|Participant Flow|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection every week (qw) from Week 1 to Week 15.
86297|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86521|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes
86304|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86305|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86306|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86307|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86308|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86309|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86310|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86311|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86312|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86313|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86314|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86315|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86316|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86317|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86318|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86319|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86320|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86321|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86322|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86323|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86422|NCT01859715|B1|Baseline|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
87584|NCT01854645|B3|Baseline|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
86325|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86326|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86327|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86328|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86329|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86330|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86522|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
86331|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86332|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86333|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86334|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86335|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86336|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86337|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86338|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86339|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86340|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86341|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86342|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86343|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86344|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86345|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86346|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86347|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86348|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86349|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86350|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86351|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86423|NCT01859715|P3|Participant Flow|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
86352|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86353|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86354|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86355|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86356|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86357|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86358|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86359|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86360|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86361|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86362|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86363|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86364|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86365|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86366|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86367|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86368|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86369|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86370|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86371|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86372|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86373|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86374|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86375|NCT01859988|O6|Outcome|Placebo|Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
86376|NCT01859988|O5|Outcome|Dupilumab 100 mg q4w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86377|NCT01859988|O4|Outcome|Dupilumab 300 mg q4w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
86378|NCT01859988|O3|Outcome|Dupilumab 200 mg q2w|Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
87585|NCT01854645|B2|Baseline|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
86379|NCT01859988|O2|Outcome|Dupilumab 300 mg q2w|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86380|NCT01859988|O1|Outcome|Dupilumab 300 mg qw|Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
86381|NCT01859988|E6|Reported Event|Placebo|Participants who received 2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15.
86382|NCT01859988|E5|Reported Event|Dupilumab 100 mg q4w|Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
86383|NCT01859988|E4|Reported Event|Dupilumab 300 mg q4w|Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
86384|NCT01859988|E3|Reported Event|Dupilumab 200 mg q2w|Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
86385|NCT01859988|E2|Reported Event|Dupilumab 300 mg q2w|Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
86391|NCT01859949|P1|Participant Flow|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
86392|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
86393|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
86394|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
86395|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
86396|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
86397|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
86398|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
86399|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
86400|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
86401|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
86402|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
86403|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
86404|NCT01859949|E2|Reported Event|Dose-Remainig Group|Participants in the 0.067 mg/kg/day group in previous study were maintained on the dose in this expention study
86405|NCT01859949|E1|Reported Event|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
86406|NCT01859793|B3|Baseline|Total|Total of all reporting groups
86407|NCT01859793|B2|Baseline|Sitagliptin 1st|"100mg pill, PO administered once daily.
sitagliptin: 100 mg pill, administered once/day orally"
86408|NCT01859793|B1|Baseline|Matching Placebo 1st|"Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally"
86409|NCT01859793|P2|Participant Flow|Sitagliptin First Then Placebo|sitagliptin: 100 mg pill, administered once/day orally for 8 weeks followed by matching placebo for 8 weeks following a 4 week washout period.
86410|NCT01859793|P1|Participant Flow|Placebo 1st Then Sitagliptin|"Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally for 8 weeks followed by 8 weeks of 100 mg sitaglipin/day separated by a 4 week washout period"
86411|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.
sitagliptin: 100 mg pill, administered once/day orally"
86412|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally"
86413|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.
sitagliptin: 100 mg pill, administered once/day orally"
86414|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally"
86415|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.
sitagliptin: 100 mg pill, administered once/day orally"
86416|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally"
86417|NCT01859793|E2|Reported Event|Sitagliptin|"100mg pill, PO administered once daily.
sitagliptin: 100 mg pill, administered once/day orally"
86418|NCT01859793|E1|Reported Event|Matching Placebo|"Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally"
86419|NCT01859715|B4|Baseline|Total|Total of all reporting groups
86420|NCT01859715|B3|Baseline|Nausea-observational Group|Patients given ondansetron for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
89817|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
86425|NCT01859715|P1|Participant Flow|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
86426|NCT01859715|O3|Outcome|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
86427|NCT01859715|O2|Outcome|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
86428|NCT01859715|O1|Outcome|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
86429|NCT01859715|O3|Outcome|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
86430|NCT01859715|O2|Outcome|Hydrocodone/Acetaminophen Group|Subjects given or hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
86431|NCT01859715|O1|Outcome|Oxycodone Group|Subjects given oxycodone 5mg mg by ED provider decision or by triage nurse randomization.
86523|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes:
86432|NCT01859715|E3|Reported Event|Nausea-observational Group|"Patients given ondansetron by ED provider decision or by triage nurse. This is an observational cohort only.
Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
Ondansetron: Subjects given ondansetron for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only."
86433|NCT01859715|E2|Reported Event|Hydrocodone/Acetaminophen Group|"Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization."
86434|NCT01859715|E1|Reported Event|Oxycodone Group|"Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization."
86435|NCT01859702|B1|Baseline|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
86436|NCT01859702|P1|Participant Flow|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
86437|NCT01859702|O1|Outcome|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
86438|NCT01859702|E1|Reported Event|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
86439|NCT01859637|B1|Baseline|Zarzio®/Filgrastim HEXAL®|Open label single arm. All patients received Zarzio®/Filgrastim HEXAL® subcutaneously dosed as per recommendations in SmPC.
86440|NCT01859637|P1|Participant Flow|Zarzio®/Filgrastim HEXAL® (EP2006)|Open label single arm. All patients received Zarzio® subcutaneously dosed as per recommendations in Summary of Product Characteristics (SmPC).
86441|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
86442|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
86443|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
86444|NCT01859637|E1|Reported Event|Open-label Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
86445|NCT01859611|B1|Baseline|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.
TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
86446|NCT01859611|P1|Participant Flow|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.
TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
86447|NCT01859611|O1|Outcome|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.
TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
86448|NCT01859611|E1|Reported Event|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.
TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
86449|NCT01859598|B1|Baseline|Follow up for 6 Months|"At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);"
86450|NCT01859598|P1|Participant Flow|6-month Follow-up for Basal Insulin Treatment Study (ORBIT)|"At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);"
86451|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341, among them, 10416 patients had FPG information"
86452|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341, among them, 10416 patients had FPG information"
86453|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
86454|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
86455|NCT01859598|O1|Outcome|Basal Insulin Treatment Study (ORBIT)|
86456|NCT01859598|E1|Reported Event|Follow up for 6 Months|"At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
86457|NCT01859507|B1|Baseline|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.
Trade Name:
BOTOX 100 units vial
Injection of Botox in the perineal muscles in resistant cases of vaginismus"
86458|NCT01859507|P1|Participant Flow|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.
Trade Name:
BOTOX 100 units vial
Injection of Botox in the perineal muscles in resistant cases of vaginismus"
86459|NCT01859507|O1|Outcome|BOTOX Group|"Injection of BOTOX 100 units vial as a single dose intramuscular in the perineal muscles. Proper informed consent forms will be signed. In most of the cases we use local anesthetic before injection. However in V4 and 5 we resort to general anesthesia. We followed up the patient by phone calls daily for possible adverse effects following the procedure for 4 days, which is the interval allowed for the BOTOX to be fully effective. The patient is then instructed to attend dilatation sessions twice weekly in the clinic, in the presence of the husband, for 3-4 weeks. We use silicone dilators covered by lubricated condoms. We start each session with the appropriate size of the dilator according to the capacity of the introitus and increase the size gradually thereafter. We proceed till the patient uses the largest dilator with no or limited pain. The patient is then advised then to try to have intercourse and report back to us.
Botox: In the first session, proper histor"
86460|NCT01859507|O1|Outcome|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.
Trade Name:
BOTOX 100 units vial
Injection of Botox in the perineal muscles in resistant cases of vaginismus"
86461|NCT01859507|E1|Reported Event|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.
Trade Name:
BOTOX 100 units vial
Injection of Botox in the perineal muscles in resistant cases of vaginismus"
86462|NCT01859494|B1|Baseline|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.
NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
86463|NCT01859494|P1|Participant Flow|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.
NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
86464|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.
NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
86465|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.
NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
86466|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.
NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
86467|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.
NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
87586|NCT01854645|B1|Baseline|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
86468|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.
NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
86469|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.
NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
86470|NCT01859494|E1|Reported Event|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.
NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
86471|NCT01859390|B3|Baseline|Total|Total of all reporting groups
86472|NCT01859390|B2|Baseline|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86473|NCT01859390|B1|Baseline|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86474|NCT01859390|P2|Participant Flow|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86475|NCT01859390|P1|Participant Flow|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86476|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86477|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86478|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86479|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86556|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
86480|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86481|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86524|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes:
86525|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes:
86526|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes:
86482|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86483|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86484|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86485|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86486|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86487|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86488|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86489|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86490|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86491|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86527|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
86528|NCT01859247|E8|Reported Event|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
86492|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86493|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86494|NCT01859390|E2|Reported Event|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86495|NCT01859390|E1|Reported Event|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
86496|NCT01859247|B9|Baseline|Total|Total of all reporting groups
86497|NCT01859247|B8|Baseline|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
86498|NCT01859247|B7|Baseline|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
86499|NCT01859247|B6|Baseline|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
86500|NCT01859247|B5|Baseline|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
86501|NCT01859247|B4|Baseline|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
86502|NCT01859247|B3|Baseline|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
86503|NCT01859247|B2|Baseline|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
86504|NCT01859247|B1|Baseline|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
86505|NCT01859247|P8|Participant Flow|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
86506|NCT01859247|P7|Participant Flow|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
86507|NCT01859247|P6|Participant Flow|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
86557|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
86508|NCT01859247|P5|Participant Flow|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
86509|NCT01859247|P4|Participant Flow|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
86510|NCT01859247|P3|Participant Flow|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
86511|NCT01859247|P2|Participant Flow|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
86512|NCT01859247|P1|Participant Flow|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
86513|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes:
86514|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes:
86515|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes:
86516|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes:
86517|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
86518|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes
86519|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes
86520|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes
86529|NCT01859247|E7|Reported Event|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
86530|NCT01859247|E6|Reported Event|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
86531|NCT01859247|E5|Reported Event|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
86532|NCT01859247|E4|Reported Event|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
86533|NCT01859247|E3|Reported Event|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
86534|NCT01859247|E2|Reported Event|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
86535|NCT01859247|E1|Reported Event|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
86536|NCT01859143|B3|Baseline|Total|Total of all reporting groups
86537|NCT01859143|B2|Baseline|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
86538|NCT01859143|B1|Baseline|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
86539|NCT01859143|P2|Participant Flow|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
86540|NCT01859143|P1|Participant Flow|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
86541|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
86542|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
86543|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
86544|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
86545|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
86546|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
86547|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
86548|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
86549|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
86550|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
86551|NCT01859143|E2|Reported Event|PLACEBO|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
86552|NCT01859143|E1|Reported Event|TRIVALENT VACCINE|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
86553|NCT01859078|B1|Baseline|Baricitinib + Digoxin|"Digoxin - 0.5 mg administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 16.
Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16."
86554|NCT01859078|P1|Participant Flow|Baricitinib + Digoxin|"Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16.
Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16."
86555|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
87587|NCT01854645|P5|Participant Flow|Placebo|Placebo MDI
86558|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
86559|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
86560|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
86561|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
86562|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
86563|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
86564|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
86565|NCT01859078|E2|Reported Event|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
86566|NCT01859078|E1|Reported Event|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
86568|NCT01859013|B2|Baseline|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.
Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
86569|NCT01859013|B1|Baseline|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.
Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
86570|NCT01859013|P2|Participant Flow|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.
Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
86571|NCT01859013|P1|Participant Flow|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.
Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
86572|NCT01859013|O2|Outcome|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.
Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
86573|NCT01859013|O1|Outcome|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.
Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
86574|NCT01859013|E2|Reported Event|Sugar Pill|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.
Placebo: Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study."
86575|NCT01859013|E1|Reported Event|Topiramate|"Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.
Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial."
86576|NCT01858766|B20|Baseline|Total|Total of all reporting groups
86577|NCT01858766|B19|Baseline|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
86578|NCT01858766|B18|Baseline|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
86579|NCT01858766|B17|Baseline|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
86580|NCT01858766|B16|Baseline|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
86581|NCT01858766|B15|Baseline|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
86582|NCT01858766|B14|Baseline|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
86583|NCT01858766|B13|Baseline|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
86584|NCT01858766|B12|Baseline|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
86585|NCT01858766|B11|Baseline|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
86586|NCT01858766|B10|Baseline|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
86587|NCT01858766|B9|Baseline|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
86588|NCT01858766|B8|Baseline|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
86589|NCT01858766|B7|Baseline|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
86590|NCT01858766|B6|Baseline|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
86591|NCT01858766|B5|Baseline|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
86592|NCT01858766|B4|Baseline|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
86593|NCT01858766|B3|Baseline|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
86594|NCT01858766|B2|Baseline|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
86595|NCT01858766|B1|Baseline|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
86596|NCT01858766|P19|Participant Flow|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
86597|NCT01858766|P18|Participant Flow|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
86598|NCT01858766|P17|Participant Flow|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
86599|NCT01858766|P16|Participant Flow|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
86600|NCT01858766|P15|Participant Flow|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
86601|NCT01858766|P14|Participant Flow|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
86602|NCT01858766|P13|Participant Flow|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
86603|NCT01858766|P12|Participant Flow|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
86604|NCT01858766|P11|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
86605|NCT01858766|P10|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
86606|NCT01858766|P9|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
86607|NCT01858766|P8|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
86608|NCT01858766|P7|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
86609|NCT01858766|P6|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
86610|NCT01858766|P5|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
86611|NCT01858766|P4|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
86612|NCT01858766|P3|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
86613|NCT01858766|P2|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
86614|NCT01858766|P1|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT1)|Sofosbuvir (SOF) 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 1)
86615|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
86616|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
86617|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
86618|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
86619|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
86620|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
86621|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
86622|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
86623|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
87588|NCT01854645|P4|Participant Flow|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
86624|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
86625|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
86626|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
86627|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
86628|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
86629|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
86630|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
86631|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
86632|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
86633|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
86675|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
86634|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
86635|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
86636|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
86637|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
86638|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
86639|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
86640|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
86641|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
86642|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
86643|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
86644|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
86645|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
86646|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
86647|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
86648|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
86649|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
86650|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
86651|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
86652|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
86653|NCT01858766|O6|Outcome|SOF+VEL 100 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
86654|NCT01858766|O5|Outcome|SOF+VEL 100 mg 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
86655|NCT01858766|O4|Outcome|SOF+VEL 25 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
86656|NCT01858766|O3|Outcome|SOF+VEL 25 mg 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
86657|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
86658|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
86659|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
86660|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
86661|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
86662|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
86663|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
86664|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
86665|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
86666|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
86667|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
86668|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
86669|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
86670|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
86671|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
86672|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
86673|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
86674|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
88541|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
86676|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
86677|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
86678|NCT01858766|E6|Reported Event|SOF+VEL 100 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
86679|NCT01858766|E5|Reported Event|SOF+VEL 100 mg 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
86680|NCT01858766|E4|Reported Event|SOF+VEL 25 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
86681|NCT01858766|E3|Reported Event|SOF+VEL 25 mg 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
86682|NCT01858766|E2|Reported Event|SOF+VEL 100 mg 12 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
86683|NCT01858766|E1|Reported Event|SOF+VEL 25 mg 12 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
86684|NCT01858701|B1|Baseline|Overall|Lotrafilcon B toric contact lenses and comfilcon A toric contact lenses worn during Period 1 and Period 2 in a crossover assignment.
86685|NCT01858701|P2|Participant Flow|Biofinity Toric / AO for Astig|Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2.
86686|NCT01858701|P1|Participant Flow|AO for Astig / Biofinity Toric|Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2.
86687|NCT01858701|O2|Outcome|Biofinity Toric|Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
86688|NCT01858701|O1|Outcome|Air Optix for Astig|Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
86689|NCT01858701|E2|Reported Event|Biofinity Toric|Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
86690|NCT01858701|E1|Reported Event|Air Optix for Astig|Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
86691|NCT01858636|B1|Baseline|Angio-Seal VIP Vascular Closure|Angio-Seal VIP 6F and 8F devices: These devices are used for the vascular closure procedure
86692|NCT01858636|P1|Participant Flow|Angio-Seal VIP Vascular Closure|Angio-Seal VIP 6 French (6F) and 8 French (8F) devices: These devices are used for the vascular closure procedure
86693|NCT01858636|O1|Outcome|Deployed Subjects|Subjects with Angio-Seal deployed
86694|NCT01858636|O1|Outcome|Deployed Subjects|Percentage of subjects who experienced a major vascular complication during 30-days post procedure.
86695|NCT01858636|E1|Reported Event|Deployed Subjects|Adverse Events (AEs) are provided for all subjects that underwent a study device deployment.
86696|NCT01858389|B3|Baseline|Total|Total of all reporting groups
86697|NCT01858389|B2|Baseline|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
86698|NCT01858389|B1|Baseline|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
86699|NCT01858389|P2|Participant Flow|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
86700|NCT01858389|P1|Participant Flow|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
86812|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86701|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg|Participants received a 1-week lead-in cycle of dacomitinib, 45 mg, every 12 hours for 6 doses on Days 1-4. Following the lead-in cycle, all participants received intermittent dacomitinib, 60 mg, administered every 12 hours for 6 doses at the beginning of each 2-week cycle.
86702|NCT01858389|O1|Outcome|Dacomitinib, 45 mg|Participants received a 1-week lead-in cycle of dacomitinib, 45 mg, every 12 hours for 6 doses on Days 1-4.
86703|NCT01858389|O1|Outcome|Dacomitinib, 45 mg|Participants received a 1-week lead-in cycle of dacomitinib, 45 mg, every 12 hours for 6 doses on Days 1-4.
86704|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
86705|NCT01858389|O2|Outcome|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
86706|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
86707|NCT01858389|O2|Outcome|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
86708|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
86709|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
86710|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
86711|NCT01858389|O1|Outcome|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
86712|NCT01858389|E2|Reported Event|Dacomitinib, 45/60 mg, Without T790M Mutation|Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
86713|NCT01858389|E1|Reported Event|Dacomitinib, 45/60 mg, With T790M Mutation|Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
86714|NCT01858376|B1|Baseline|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.
Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws, 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
86715|NCT01858376|P1|Participant Flow|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.
Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
86716|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.
Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
86813|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
87589|NCT01854645|P3|Participant Flow|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
86717|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.
Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
86718|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.
Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
86719|NCT01858376|E1|Reported Event|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.
Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
86720|NCT01857986|B3|Baseline|Total|Total of all reporting groups
86721|NCT01857986|B2|Baseline|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
86722|NCT01857986|B1|Baseline|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
86723|NCT01857986|P2|Participant Flow|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
86724|NCT01857986|P1|Participant Flow|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
86725|NCT01857986|O2|Outcome|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
86726|NCT01857986|O1|Outcome|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
86727|NCT01857986|O2|Outcome|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
86728|NCT01857986|O1|Outcome|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
86729|NCT01857986|O2|Outcome|Control|Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
86730|NCT01857986|O1|Outcome|Study|Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.
86731|NCT01857986|E2|Reported Event|Control|
86732|NCT01857986|E1|Reported Event|Study|
86733|NCT01857882|B3|Baseline|Total|Total of all reporting groups
86734|NCT01857882|B2|Baseline|Standard Care|Routine pre-consultation education
86735|NCT01857882|B1|Baseline|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.
Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
Social worker (30 mins): values clarification exercise
Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
86736|NCT01857882|P2|Participant Flow|Standard Care|Routine pre-consultation education
86756|NCT01857622|O3|Outcome|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
DU-176b 60mg: oral DU-176b 60mg once daily"
86814|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
87590|NCT01854645|P2|Participant Flow|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
86737|NCT01857882|P1|Participant Flow|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.
Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
Social worker (30 mins): values clarification exercise
Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
86738|NCT01857882|O2|Outcome|Standard Care|Routine pre-consultation education
86739|NCT01857882|O1|Outcome|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.
Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
Social worker (30 mins): values clarification exercise
Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
86740|NCT01857882|E2|Reported Event|Standard Care|Routine pre-consultation education
86741|NCT01857882|E1|Reported Event|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.
Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
Social worker (30 mins): values clarification exercise
Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
86742|NCT01857713|B1|Baseline|Fitted With Reza Band UES Assist Device|Patients were their own control and Fitted with Reza Band UES Assist Device. Results were obtained by measuring symptoms at baseline and then compared at each of the prescribed follow-up visits.
89809|NCT01843348|B3|Baseline|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
86743|NCT01857713|P1|Participant Flow|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and served as their own control. Baseline measures were comported to follow-up visit measures.
86744|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
86745|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
86746|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
86747|NCT01857713|O1|Outcome|Reza Band|Participants fitted with Reza Band UES Assist Device
86748|NCT01857713|E1|Reported Event|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and were their own controls. Baseline measures were compared to each of the prescribed follow-up visit measures.
86749|NCT01857622|B4|Baseline|Total|Total of all reporting groups
86750|NCT01857622|B3|Baseline|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
DU-176b 60mg: oral DU-176b 60mg once daily"
86751|NCT01857622|B2|Baseline|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
DU-176b 30mg: oral DU-176b 30mg once daily"
86752|NCT01857622|B1|Baseline|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.
DU-176b 15mg: oral DU-176b 15mg once daily"
86753|NCT01857622|P3|Participant Flow|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
DU-176b 60mg: oral DU-176b 60mg once daily"
86754|NCT01857622|P2|Participant Flow|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
DU-176b 30mg: oral DU-176b 30mg once daily"
86755|NCT01857622|P1|Participant Flow|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.
DU-176b 15mg: oral DU-176b 15mg once daily"
86810|NCT01857297|P1|Participant Flow|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
89818|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
86757|NCT01857622|O2|Outcome|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
DU-176b 30mg: oral DU-176b 30mg once daily"
86758|NCT01857622|O1|Outcome|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.
DU-176b 15mg: oral DU-176b 15mg once daily"
86759|NCT01857622|E3|Reported Event|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
DU-176b 60mg: oral DU-176b 60mg once daily"
86760|NCT01857622|E2|Reported Event|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
DU-176b 30mg: oral DU-176b 30mg once daily"
86761|NCT01857622|E1|Reported Event|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.
DU-176b 15mg: oral DU-176b 15mg once daily"
86762|NCT01857583|B5|Baseline|Total|Total of all reporting groups
86763|NCT01857583|B4|Baseline|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.
(20 mL/min ≤ CLCR < 30mL/min)"
86764|NCT01857583|B3|Baseline|SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.
(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
86765|NCT01857583|B2|Baseline|SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
86766|NCT01857583|B1|Baseline|MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.
(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
86894|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86767|NCT01857583|P4|Participant Flow|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.
(20 mL/min ≤ CLCR < 30mL/min) Fondaparinux"
86768|NCT01857583|P3|Participant Flow|SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.
(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
86769|NCT01857583|P2|Participant Flow|SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
86770|NCT01857583|P1|Participant Flow|MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.
(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
86771|NCT01857583|O4|Outcome|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.
(20 mL/min ≤ CLCR < 30mL/min)"
86772|NCT01857583|O3|Outcome|SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.
(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
86773|NCT01857583|O2|Outcome|SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
86774|NCT01857583|O1|Outcome|MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.
(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
86775|NCT01857583|E4|Reported Event|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.
Fondaparinux (20 mL/min ≤ CLCR < 30mL/min)"
86776|NCT01857583|E3|Reported Event|SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.
(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
86777|NCT01857583|E2|Reported Event|SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
86778|NCT01857583|E1|Reported Event|MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.
(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
86779|NCT01857531|B1|Baseline|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:
Ganaxolone -- 400mg daily for the first 3 days, 800mg daily for the next 3 days and 1200mg daily for the remainder of the first 2 wks.
Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.
Post-Quit Period:
Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.
Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
86780|NCT01857531|P1|Participant Flow|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:
Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.
Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.
Post-Quit Period:
Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.
Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
86781|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:
Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.
Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.
Post-Quit Period:
Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.
Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
86811|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86782|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:
Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.
Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.
Post-Quit Period:
Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.
Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
86783|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:
Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.
Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.
Post-Quit Period:
Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.
Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
86784|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:
Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.
Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.
Post-Quit Period:
Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.
Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
86785|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:
Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.
Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.
Post-Quit Period:
Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.
Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
86786|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:
Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.
Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.
Post-Quit Period:
Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.
Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
86787|NCT01857531|E1|Reported Event|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:
Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.
Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.
Post-Quit Period:
Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.
Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
86788|NCT01857362|B1|Baseline|Overall Study|All treatment arms
86895|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
86789|NCT01857362|P2|Participant Flow|Nitisinone 2 x 10 mg, Then Nitisinone 1 x 20 mg|Participants first received two nitisinone capsules of 10 mg. After washout of 3 weeks participants then received one nitisinone capsule of 20 mg.
86790|NCT01857362|P1|Participant Flow|Nitisinone 1 x 20 mg, Then Nitisinone 2 x 10 mg|Participants first received one nitisinone capsule of 20 mg. After washout of 3 weeks participants then received two nitisinone capsules of 10 mg.
86791|NCT01857362|O2|Outcome|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
86792|NCT01857362|O1|Outcome|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
86793|NCT01857362|O2|Outcome|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
86794|NCT01857362|O1|Outcome|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
86795|NCT01857362|E2|Reported Event|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
86796|NCT01857362|E1|Reported Event|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
86797|NCT01857323|B1|Baseline|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
86798|NCT01857323|P1|Participant Flow|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
86799|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
86800|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
86801|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
86802|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
86803|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
86804|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
86805|NCT01857323|E1|Reported Event|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
86806|NCT01857297|B3|Baseline|Total|Total of all reporting groups
86807|NCT01857297|B2|Baseline|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86808|NCT01857297|B1|Baseline|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86809|NCT01857297|P2|Participant Flow|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
87591|NCT01854645|P1|Participant Flow|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
86815|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86816|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86817|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86818|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86819|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86820|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86821|NCT01857297|E2|Reported Event|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86822|NCT01857297|E1|Reported Event|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
86823|NCT01857258|B1|Baseline|Baseline Participant Characteristics|All participants completed both arms of the cross-over study
86850|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
86851|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
86824|NCT01857258|P2|Participant Flow|Control First, Then Green Tea|"Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.
The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate."
86825|NCT01857258|P1|Participant Flow|Green Tea First, Then Control|"Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.
The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate."
86826|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86827|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86828|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86829|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86830|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86831|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86832|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86833|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86834|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86835|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86836|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86837|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86838|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86839|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86840|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
87592|NCT01854645|O5|Outcome|Placebo|Placebo MDI
86841|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86842|NCT01857258|E2|Reported Event|Control, Then Green Tea|"Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86843|NCT01857258|E1|Reported Event|Green Tea, Then Control|"Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.
Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
86844|NCT01857206|B3|Baseline|TOTAL|Total of all reporting groups
86845|NCT01857206|B2|Baseline|TIVf|Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
86846|NCT01857206|B1|Baseline|TIVc|Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
86847|NCT01857206|P2|Participant Flow|TIVf|Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
86848|NCT01857206|P1|Participant Flow|TIVc|Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
86849|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
86852|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
86853|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
86854|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
86855|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
86856|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
86857|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
86858|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
86859|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
86860|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
86861|NCT01857206|E4|Reported Event|TIVf(9-17Years )|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
86862|NCT01857206|E3|Reported Event|TIVc(9-17Years )|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
86863|NCT01857206|E2|Reported Event|TIVf(4-8Years )|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
86864|NCT01857206|E1|Reported Event|TIVc(4-8Years )|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
86865|NCT01857102|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
86866|NCT01857102|P2|Participant Flow|Etafilcon A for Astigmatism/Etafilcon A|Subjects that first received the etafilcon A for Astigmatism lens and then received the etafilcon A lens.
86867|NCT01857102|P1|Participant Flow|Etafilcon A/ Etafilcon A for Astigmatism|Subjects that first received the etafilcon A lens and then received the etafilcon A for Astigmatism lens.
86868|NCT01857102|O2|Outcome|Etafilcon A for Astigmatism|Subjects that received etafilcon A for Astigmatism lens in either the first or second period of the study.
86869|NCT01857102|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A lens during the first or second period of the study.
86870|NCT01857102|O2|Outcome|Etafilcon A for Astigmatism|Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
86871|NCT01857102|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
86872|NCT01857102|E2|Reported Event|Etafilcon A for Astigmatism|Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
86873|NCT01857102|E1|Reported Event|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
86874|NCT01857063|B3|Baseline|Total|Total of all reporting groups
86875|NCT01857063|B2|Baseline|Placebo/Montelukast|Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
86876|NCT01857063|B1|Baseline|Montelukast/Placebo|Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
86877|NCT01857063|P2|Participant Flow|Placebo/Montelukast|Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
86878|NCT01857063|P1|Participant Flow|Montelukast/Placebo|Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
86879|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
86880|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86881|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
86882|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86883|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
86884|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86885|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
86886|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86887|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
86888|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86889|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
86890|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86891|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
86892|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86896|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86897|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
86898|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86899|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
86900|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86901|NCT01857063|E2|Reported Event|Placebo|Participants receive placebo for 7 days, regardless of sequence.
86902|NCT01857063|E1|Reported Event|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
86903|NCT01856933|B1|Baseline|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks
PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
86904|NCT01856933|P1|Participant Flow|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks
PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
86905|NCT01856933|O1|Outcome|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks
PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
86906|NCT01856933|E1|Reported Event|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks
PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
86907|NCT01856764|B3|Baseline|Total|Total of all reporting groups
86908|NCT01856764|B2|Baseline|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
86909|NCT01856764|B1|Baseline|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
86910|NCT01856764|P2|Participant Flow|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
86911|NCT01856764|P1|Participant Flow|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
86912|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
86913|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
86914|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
86915|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
86916|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
86917|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
86918|NCT01856764|E2|Reported Event|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
86919|NCT01856764|E1|Reported Event|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
86920|NCT01856686|B3|Baseline|Total|Total of all reporting groups
86921|NCT01856686|B2|Baseline|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86922|NCT01856686|B1|Baseline|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86923|NCT01856686|P2|Participant Flow|Low Carbohydrate Diet|This group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
86924|NCT01856686|P1|Participant Flow|BP22042013|This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
86925|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
87252|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
86926|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86927|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86928|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86929|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86930|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86931|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86932|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
87002|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
86933|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86934|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86935|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86936|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86937|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86938|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86939|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86940|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86941|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86942|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86943|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86944|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86945|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86946|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86947|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86948|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86949|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86950|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86951|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86952|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86953|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
87003|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray
Placebo: Matched placebo nasal spray"
89810|NCT01843348|B2|Baseline|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
86954|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86955|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86956|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86957|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86958|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86959|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86960|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86961|NCT01856686|E2|Reported Event|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
86962|NCT01856686|E1|Reported Event|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
86963|NCT01856673|B4|Baseline|Total|Total of all reporting groups
86964|NCT01856673|B3|Baseline|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.
Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
86982|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
86983|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
87379|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
86965|NCT01856673|B2|Baseline|ARM 2: Community Group Therapy|"Community Group Therapy (CGT) only
Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by MHCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. MHCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the MHCW. Finally, session closes with a motivating activity."
86966|NCT01856673|B1|Baseline|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only
Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Mental Health Community Workers (MHCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
86967|NCT01856673|P3|Participant Flow|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.
Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
87004|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
87005|NCT01856530|E2|Reported Event|Placebo|"Matched placebo nasal spray
Placebo: Matched placebo nasal spray"
87006|NCT01856530|E1|Reported Event|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
87007|NCT01856361|B3|Baseline|Total|Total of all reporting groups
87267|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
86968|NCT01856673|P2|Participant Flow|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only
Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
86969|NCT01856673|P1|Participant Flow|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only
Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
86970|NCT01856673|O3|Outcome|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.
Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
86971|NCT01856673|O2|Outcome|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only
Narrative Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
86984|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
87416|NCT01854944|B4|Baseline|Total|Total of all reporting groups
89819|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
86972|NCT01856673|O1|Outcome|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only
Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
86973|NCT01856673|O3|Outcome|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.
Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
86974|NCT01856673|O2|Outcome|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only
Narrative Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
86975|NCT01856673|O1|Outcome|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only
Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
87008|NCT01856361|B2|Baseline|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.
Placebo: Placebo pill that will match the treatment pill"
87602|NCT01854645|O5|Outcome|Placebo|Placebo MDI
86976|NCT01856673|E3|Reported Event|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.
Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
86977|NCT01856673|E2|Reported Event|ARM 2: Community Group Therapy|"Community Group Therapy (CGT) only
Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by MHCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. MHCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the MHCW. Finally, session closes with a motivating activity."
86978|NCT01856673|E1|Reported Event|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only
Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Mental Health Community Workers (MHCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
86979|NCT01856569|B1|Baseline|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
86980|NCT01856569|P1|Participant Flow|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
86981|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
86985|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
86986|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
86987|NCT01856569|E1|Reported Event|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
86988|NCT01856530|B3|Baseline|Total|Total of all reporting groups
86989|NCT01856530|B2|Baseline|Placebo|"Matched placebo nasal spray
Placebo: Matched placebo nasal spray"
86990|NCT01856530|B1|Baseline|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
86991|NCT01856530|P2|Participant Flow|Placebo|"Matched placebo nasal spray
Placebo: Matched placebo nasal spray"
86992|NCT01856530|P1|Participant Flow|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
86993|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray
Placebo: Matched placebo nasal spray"
86994|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
86995|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray
Placebo: Matched placebo nasal spray"
86996|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
86997|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray
Placebo: Matched placebo nasal spray"
86998|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
86999|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray
Placebo: Matched placebo nasal spray"
87000|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once
Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
87001|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray
Placebo: Matched placebo nasal spray"
87009|NCT01856361|B1|Baseline|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.
Ramipril: Angiotensin Converting Enzyme Inhibitor"
87010|NCT01856361|P2|Participant Flow|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.
Placebo: Placebo pill that will match the treatment pill"
87011|NCT01856361|P1|Participant Flow|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.
Ramipril: Angiotensin Converting Enzyme Inhibitor"
87012|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.
Placebo: Placebo pill that will match the treatment pill"
87013|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.
Ramipril: Angiotensin Converting Enzyme Inhibitor"
87014|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.
Placebo: Placebo pill that will match the treatment pill"
87015|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.
Ramipril: Angiotensin Converting Enzyme Inhibitor"
87016|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.
Placebo: Placebo pill that will match the treatment pill"
87017|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.
Ramipril: Angiotensin Converting Enzyme Inhibitor"
87018|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.
Placebo: Placebo pill that will match the treatment pill"
87019|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.
Ramipril: Angiotensin Converting Enzyme Inhibitor"
87020|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.
Placebo: Placebo pill that will match the treatment pill"
87021|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.
Ramipril: Angiotensin Converting Enzyme Inhibitor"
87022|NCT01856361|E2|Reported Event|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.
Placebo: Placebo pill that will match the treatment pill"
87495|NCT01854697|B6|Baseline|Total|Total of all reporting groups
87023|NCT01856361|E1|Reported Event|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.
Ramipril: Angiotensin Converting Enzyme Inhibitor"
87024|NCT01856322|B4|Baseline|Total|Total of all reporting groups
87025|NCT01856322|B3|Baseline|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
87026|NCT01856322|B2|Baseline|Placebo|"one tablet twice daily
Placebo: One tablet twice daily"
87027|NCT01856322|B1|Baseline|Sulindac|"one tablet twice daily
Sulindac: one tablet twice daily"
87028|NCT01856322|P3|Participant Flow|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
87029|NCT01856322|P2|Participant Flow|Placebo|"one tablet twice daily
Placebo: One tablet twice daily"
87030|NCT01856322|P1|Participant Flow|Sulindac|"one tablet twice daily
Sulindac: one tablet twice daily"
87031|NCT01856322|O2|Outcome|Placebo|"one tablet twice daily
Placebo: One tablet twice daily"
87032|NCT01856322|O1|Outcome|Sulindac|"one tablet twice daily
Sulindac: one tablet twice daily"
87033|NCT01856322|E3|Reported Event|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
87034|NCT01856322|E2|Reported Event|Placebo|"one tablet twice daily
Placebo: One tablet twice daily"
87035|NCT01856322|E1|Reported Event|Sulindac|"one tablet twice daily
Sulindac: one tablet twice daily"
87036|NCT01856257|B4|Baseline|Total|Total of all reporting groups
87037|NCT01856257|B3|Baseline|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87038|NCT01856257|B2|Baseline|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87039|NCT01856257|B1|Baseline|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87040|NCT01856257|P4|Participant Flow|Enrolled, Not Randomized|Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
87041|NCT01856257|P3|Participant Flow|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87042|NCT01856257|P2|Participant Flow|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87043|NCT01856257|P1|Participant Flow|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87248|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87573|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
87044|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87045|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87046|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87137|NCT01856257|E4|Reported Event|Enrolled, Not Randomized|Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
87152|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87233|NCT01855945|P7|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87047|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87048|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87049|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87050|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87051|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87052|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87053|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87054|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87055|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87603|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
87056|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87057|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87058|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87059|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87060|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87061|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87062|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87063|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87064|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87604|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
87065|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87066|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87067|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87068|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87069|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87070|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87071|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87072|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87073|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87605|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
87074|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87075|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87076|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87077|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87078|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87079|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87080|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87081|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87082|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87606|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
87083|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87084|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87085|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87086|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87087|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87088|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87089|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87090|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87091|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87607|NCT01854645|O5|Outcome|Placebo|Placebo MDI
87092|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87093|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87094|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87095|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87096|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87097|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87098|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87099|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87100|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87608|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
87101|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87102|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87103|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87104|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87105|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87106|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87107|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87108|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87109|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87609|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
87110|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87111|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87112|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87113|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87114|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87115|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87116|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87117|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87118|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87610|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
87119|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87120|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87121|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87122|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87123|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87124|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87125|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87126|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87127|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87611|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
87128|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87129|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87130|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87131|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87132|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87133|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87134|NCT01856257|O3|Outcome|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87135|NCT01856257|O2|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87136|NCT01856257|O1|Outcome|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87612|NCT01854645|O5|Outcome|Placebo|Placebo MDI
87138|NCT01856257|E3|Reported Event|Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84"
87139|NCT01856257|E2|Reported Event|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1."
87140|NCT01856257|E1|Reported Event|Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac|"Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter."
87141|NCT01855997|B1|Baseline|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87142|NCT01855997|P1|Participant Flow|Adult Participants Treated With Peg-IFN|Adult participants with hepatitis B envelope antigen (HBeAg)-positive or -negative chronic hepatitis B (CHB) infection who completed greater than or equal to (≥) 24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87143|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87249|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87144|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87145|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87146|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87147|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87148|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87149|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87150|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87151|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87153|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87154|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87155|NCT01855997|O1|Outcome|HBeAg-Positive Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87156|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87157|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87158|NCT01855997|O1|Outcome|HBeAg-Positive Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87159|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87160|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87250|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87574|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
87161|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87162|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87163|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87164|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87165|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87166|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87167|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87168|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87234|NCT01855945|P6|Participant Flow|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87613|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
87169|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87170|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87171|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87172|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87173|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87174|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87175|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87251|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87575|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
87176|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87177|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87178|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87179|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87180|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87181|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87182|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87183|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87184|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87235|NCT01855945|P5|Participant Flow|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87185|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87186|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87187|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87188|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87189|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87190|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87191|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87576|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
87192|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87193|NCT01855997|E1|Reported Event|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection, and who had completed at least 24 weeks of Peg-IFN alfa-2a with/without nucleoside analogue therapy and at least 24 weeks of follow-up, were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
87194|NCT01855958|B3|Baseline|Total|Total of all reporting groups
87195|NCT01855958|B2|Baseline|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
87196|NCT01855958|B1|Baseline|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
87197|NCT01855958|P2|Participant Flow|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
87198|NCT01855958|P1|Participant Flow|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
87209|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
87199|NCT01855958|O2|Outcome|Placebo-sham|"The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
Placebo-sham: Electro acupuncture with rubber electrodes, without current passing."
87200|NCT01855958|O1|Outcome|DIMST|"The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterior; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
DIMST: The investigators used electro acupuncture of 2 Hz during 30 minutes."
87201|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
87202|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
87577|NCT01854658|E4|Reported Event|Placebo MDI|Inhaled placebo administered as two puffs BID
87203|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
87204|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
87205|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
87206|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
87207|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
87208|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
87232|NCT01855945|P8|Participant Flow|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87614|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
87210|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
87211|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
87212|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
87213|NCT01855958|E2|Reported Event|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
87578|NCT01854658|E3|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
87214|NCT01855958|E1|Reported Event|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
87215|NCT01855945|B13|Baseline|Total|Total of all reporting groups
87216|NCT01855945|B12|Baseline|A/H3N2C : ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87217|NCT01855945|B11|Baseline|A/H3N2C + MF59 : ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87218|NCT01855945|B10|Baseline|A/H3N2C + 1/2 MF59 : ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87219|NCT01855945|B9|Baseline|A/H3N2C : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87220|NCT01855945|B8|Baseline|A/H3N2C + MF59 : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87221|NCT01855945|B7|Baseline|A/H3N2C + 1/2 MF59 : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87222|NCT01855945|B6|Baseline|A/H3N2C : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87223|NCT01855945|B5|Baseline|A/H3N2C + MF59 : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87224|NCT01855945|B4|Baseline|A/H3N2C + 1/2 MF59 : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87225|NCT01855945|B3|Baseline|A/H3N2C : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87226|NCT01855945|B2|Baseline|A/H3N2C + MF59 : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87227|NCT01855945|B1|Baseline|A/H3N2C + 1/2 MF59 : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87228|NCT01855945|P12|Participant Flow|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87229|NCT01855945|P11|Participant Flow|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87230|NCT01855945|P10|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87231|NCT01855945|P9|Participant Flow|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87236|NCT01855945|P4|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87237|NCT01855945|P3|Participant Flow|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87238|NCT01855945|P2|Participant Flow|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87239|NCT01855945|P1|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87240|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87241|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87242|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87243|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87244|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87245|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87246|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87247|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87253|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87254|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87255|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87256|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87257|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87258|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87259|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87260|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87261|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87262|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87263|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87264|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87265|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87266|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87268|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87269|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87270|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87271|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87272|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87273|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87274|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87275|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87276|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87277|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87278|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87279|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87280|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87281|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87282|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87283|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87284|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87285|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87286|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87287|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87288|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87289|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87290|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87291|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87292|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87293|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87294|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87295|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87296|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87297|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87298|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87299|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87300|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87301|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87302|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87303|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87304|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87305|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87306|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87307|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87308|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87309|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87310|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87311|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87312|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87313|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87314|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87315|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87579|NCT01854658|E2|Reported Event|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
87316|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87317|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87318|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87319|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87320|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87321|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87322|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87323|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87324|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87325|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87326|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87327|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87328|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87329|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87330|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87331|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87332|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87333|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87334|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87335|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87336|NCT01855945|O12|Outcome|A/H3N2C Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87337|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87338|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87339|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87340|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87341|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87342|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87343|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87344|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87345|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87346|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87347|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87348|NCT01855945|O3|Outcome|A/H3N2C - Age Group: ≥65 YEARS|Subjects ≥65 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 15 µg H3N2c antigen.
87349|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
87350|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87351|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87352|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87353|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87354|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87355|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87356|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59 Subjects 3 to <9 years.
87357|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87358|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
87359|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
87360|NCT01855945|E12|Reported Event|A/H3N2C Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87361|NCT01855945|E11|Reported Event|A/H3N2C + MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87362|NCT01855945|E10|Reported Event|A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87363|NCT01855945|E9|Reported Event|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87364|NCT01855945|E8|Reported Event|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87365|NCT01855945|E7|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87366|NCT01855945|E6|Reported Event|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87367|NCT01855945|E5|Reported Event|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87368|NCT01855945|E4|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87369|NCT01855945|E3|Reported Event|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
87370|NCT01855945|E2|Reported Event|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
87371|NCT01855945|E1|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
87372|NCT01855919|B3|Baseline|Total|Total of all reporting groups
87373|NCT01855919|B2|Baseline|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87374|NCT01855919|B1|Baseline|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87375|NCT01855919|P2|Participant Flow|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87376|NCT01855919|P1|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87377|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87378|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87380|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87381|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87382|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87383|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87384|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87385|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87386|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during the last week.
87387|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87388|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87389|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87390|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87391|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87392|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87393|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87394|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87395|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87396|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87397|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87398|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87399|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87400|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87401|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87402|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87403|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87404|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87405|NCT01855919|E2|Reported Event|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
87406|NCT01855919|E1|Reported Event|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
87407|NCT01855074|B1|Baseline|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
87408|NCT01855074|P1|Participant Flow|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
87409|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
87410|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
87411|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
87412|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
87413|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
87414|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
87415|NCT01855074|E1|Reported Event|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
87417|NCT01854944|B3|Baseline|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87418|NCT01854944|B2|Baseline|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87419|NCT01854944|B1|Baseline|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1-mg tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87420|NCT01854944|P3|Participant Flow|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87421|NCT01854944|P2|Participant Flow|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87422|NCT01854944|P1|Participant Flow|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1 milligram (mg) tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87423|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87424|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87425|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87426|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87427|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87428|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87429|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87430|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87615|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
87431|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87432|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87433|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87434|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87435|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87436|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87437|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87438|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87439|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87440|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87441|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87442|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87443|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87444|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87445|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87446|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87447|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87448|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87449|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87580|NCT01854658|E1|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
87581|NCT01854645|B6|Baseline|Total|Total of all reporting groups
87450|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87451|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87452|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87453|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87454|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87455|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87456|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87457|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87458|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87459|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4 mg|Participants in Cohort 3 received one 1- to 4-mg dose of brexpiprazole (at the investigator’s discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87460|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in Cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87461|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in Cohort 1 received 1-mg tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87462|NCT01854944|O1|Outcome|Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87463|NCT01854944|O2|Outcome|Brexpiprazole 4 mg|Participants received 1-mg brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87464|NCT01854944|O1|Outcome|Brexpiprazole 1mg|Participants received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87616|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
87617|NCT01854645|O5|Outcome|Placebo|Placebo MDI
87465|NCT01854944|O1|Outcome|Brexpiprazole 4mg|Participants received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87466|NCT01854944|O2|Outcome|Brexpiprazole 4 mg|Participants received 1-mg brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87467|NCT01854944|O1|Outcome|Brexpiprazole 1mg|Participants received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87468|NCT01854944|E3|Reported Event|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87469|NCT01854944|E2|Reported Event|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
87470|NCT01854944|E1|Reported Event|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received one 1-mg of brexpiprazole once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
87471|NCT01854905|B1|Baseline|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
87472|NCT01854905|P1|Participant Flow|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
87473|NCT01854905|O1|Outcome|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
87474|NCT01854905|E1|Reported Event|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
87475|NCT01853839|B1|Baseline|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
87476|NCT01853839|P1|Participant Flow|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
87477|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks."
87478|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks."
87479|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
87480|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
87481|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
87482|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
87483|NCT01853839|O2|Outcome|Internist|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks. Patients whose primary physician was a internist."
87484|NCT01853839|O1|Outcome|Cardiologist|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks. Patients whose primary physician was a cardiologist."
87485|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks."
87618|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
87619|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
87486|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks."
87487|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks."
87488|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks."
87489|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks."
87490|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks."
87491|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
87492|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
87493|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
Treatment duration is up to 52 weeks."
87494|NCT01853839|E1|Reported Event|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.
All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
87496|NCT01854697|B5|Baseline|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
87497|NCT01854697|B4|Baseline|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
87498|NCT01854697|B3|Baseline|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
87499|NCT01854697|B2|Baseline|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
87500|NCT01854697|B1|Baseline|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
87501|NCT01854697|P5|Participant Flow|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
87502|NCT01854697|P4|Participant Flow|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
87503|NCT01854697|P3|Participant Flow|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
87504|NCT01854697|P2|Participant Flow|Arm B: TPV/PR in GT1a|Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegylated interferon (pegIFN) 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
87505|NCT01854697|P1|Participant Flow|Arm A: 3-DAA + RBV in GT1a|ABT-450/ritonavir (r)/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based ribavirin (RBV) for 12 weeks (3 Direct-Acting Antivirals (DAAs) with RBV in genotype [GT] 1a)
87506|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
87507|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
87508|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
87509|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
87510|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
87511|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
87512|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
87513|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
87514|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
87515|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
87516|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
87517|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
87518|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
87519|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
87520|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
87521|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
87522|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
87523|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
87524|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
87525|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
87526|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
87527|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
87528|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
87529|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
87530|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
87531|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
87532|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
87533|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
87534|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
87535|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
87536|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
87537|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
87538|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
87620|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
87539|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
87540|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
87541|NCT01854697|E3|Reported Event|TPV + PEGIFN + RBV|TPV 750 mg q8h and pegIFN 180 μg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir
87542|NCT01854697|E2|Reported Event|3 DAA|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks
87543|NCT01854697|E1|Reported Event|3 DAA + RBV|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks
87544|NCT01854658|B5|Baseline|Total|Total of all reporting groups
87545|NCT01854658|B4|Baseline|Placebo MDI|Inhaled placebo administered as two puffs BID
87546|NCT01854658|B3|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
87547|NCT01854658|B2|Baseline|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
87548|NCT01854658|B1|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
87549|NCT01854658|P4|Participant Flow|Placebo MDI|Inhaled placebo administered as two puffs BID
87550|NCT01854658|P3|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
87551|NCT01854658|P2|Participant Flow|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
87552|NCT01854658|P1|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
87553|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
87554|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
87555|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
87556|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
87557|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
87558|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
87559|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
87560|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
87561|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
87562|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
87563|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
87564|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
87565|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
87566|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
87567|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
87568|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
87569|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
87570|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
87571|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
87572|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
87593|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
87594|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
87595|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
87596|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
87597|NCT01854645|O5|Outcome|Placebo|Placebo MDI
87598|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
87599|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
87600|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
87601|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
87621|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
87622|NCT01854645|E5|Reported Event|Placebo|Placebo MDI
87623|NCT01854645|E4|Reported Event|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
87624|NCT01854645|E3|Reported Event|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
87625|NCT01854645|E2|Reported Event|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
87626|NCT01854645|E1|Reported Event|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
87627|NCT01854632|B3|Baseline|Total|Total of all reporting groups
87628|NCT01854632|B2|Baseline|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
87629|NCT01854632|B1|Baseline|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
87630|NCT01854632|P2|Participant Flow|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
87631|NCT01854632|P1|Participant Flow|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
87632|NCT01854632|O2|Outcome|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
87633|NCT01854632|O1|Outcome|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
87634|NCT01854632|E2|Reported Event|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
87635|NCT01854632|E1|Reported Event|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
87636|NCT01854593|B3|Baseline|Total|Total of all reporting groups
87637|NCT01854593|B2|Baseline|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Sham injection: Sham injection one day before vitrectomy
Vitrectomy: vitrectomy of 25 gauge system."
87638|NCT01854593|B1|Baseline|Bevacizumab and Vitrectomy|"0.16 mg/0.05 ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87639|NCT01854593|P2|Participant Flow|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Sham injection: Sham injection one day before vitrectomy
Vitrectomy: vitrectomy of 25 gauge system."
87640|NCT01854593|P1|Participant Flow|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87641|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87642|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87643|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87644|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87645|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87646|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87647|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87648|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87649|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
88390|NCT01851330|E3|Reported Event|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
87650|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87651|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87652|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87653|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
88039|NCT01853072|E4|Reported Event|Posttreatment|All participants after cessation of study treatment up to study exit
87654|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87655|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87656|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87657|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87658|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87659|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87660|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87661|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87662|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87663|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87664|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87665|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87666|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87667|NCT01854593|E2|Reported Event|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.
Vitrectomy: vitrectomy of 25 gauge system.
Sham injection: Sham injection one day before vitrectomy"
87668|NCT01854593|E1|Reported Event|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.
Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)
Vitrectomy: vitrectomy of 25 gauge system."
87669|NCT01854528|B3|Baseline|Total|Total of all reporting groups
87670|NCT01854528|B2|Baseline|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
87671|NCT01854528|B1|Baseline|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
87672|NCT01854528|P2|Participant Flow|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
87673|NCT01854528|P1|Participant Flow|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
87674|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
87675|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
87676|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
87677|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
87678|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
87679|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
87862|NCT01853696|O2|Outcome|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months
prednisolone acetate 1%"
87680|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
87681|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
87682|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
87683|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
87684|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
87685|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
87686|NCT01854528|E2|Reported Event|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
87687|NCT01854528|E1|Reported Event|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
87688|NCT01854281|B5|Baseline|Total|Total of all reporting groups
87689|NCT01854281|B4|Baseline|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
87690|NCT01854281|B3|Baseline|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
87691|NCT01854281|B2|Baseline|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
87692|NCT01854281|B1|Baseline|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
87693|NCT01854281|P4|Participant Flow|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after Dive B.
87694|NCT01854281|P3|Participant Flow|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
87695|NCT01854281|P2|Participant Flow|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after Dive A.
87696|NCT01854281|P1|Participant Flow|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
87697|NCT01854281|O4|Outcome|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
87698|NCT01854281|O3|Outcome|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
87699|NCT01854281|O2|Outcome|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
87700|NCT01854281|O1|Outcome|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
87701|NCT01854281|E4|Reported Event|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
87702|NCT01854281|E3|Reported Event|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
87703|NCT01854281|E2|Reported Event|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
87704|NCT01854281|E1|Reported Event|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
87705|NCT01854268|B1|Baseline|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.
Healthy adults who receive capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water was available at all times.
Pulmonary function testing: Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Forced vital capacity and rest breathing maneuvers were completed.
Nebulized water (Fog): The investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. A minute break in between each presentation."
87706|NCT01854268|P1|Participant Flow|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.
Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in the chest wall and abdomen during cough. Participants breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. Participants received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants rested for a minute in between each presentation and water was available at all times.
Pulmonary function testing: Investigators placed cotton elastic bands around the chest and abdomen so that measures of chest wall and abdominal movements could be measured. Forced vital capacity and rest breathing was completed.
Nebulized water (Fog): The investigators provided nebulized water (FOG) through the facemask for up to a minute three times. A minute break was allotted between each presentation."
88040|NCT01853072|E3|Reported Event|Vehicle|All participants treated with NepafenacVehicle during the course of study treatment
87707|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.
Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
87708|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.
Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
87709|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.
Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
87710|NCT01854268|E1|Reported Event|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.
Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water will be available at all times."
87711|NCT01854242|B1|Baseline|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
87712|NCT01854242|P1|Participant Flow|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
87713|NCT01854242|O1|Outcome|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
87714|NCT01854242|E1|Reported Event|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
87715|NCT01854047|B6|Baseline|Total|Total of all reporting groups
87716|NCT01854047|B5|Baseline|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87717|NCT01854047|B4|Baseline|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87718|NCT01854047|B3|Baseline|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87719|NCT01854047|B2|Baseline|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87720|NCT01854047|B1|Baseline|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87721|NCT01854047|P5|Participant Flow|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87722|NCT01854047|P4|Participant Flow|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87723|NCT01854047|P3|Participant Flow|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87852|NCT01853982|O1|Outcome|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
87724|NCT01854047|P2|Participant Flow|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87725|NCT01854047|P1|Participant Flow|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87726|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87863|NCT01853696|O1|Outcome|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months
loteprednol etabonate 0.5% gel"
87727|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87728|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87729|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87730|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87731|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87732|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87733|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87734|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87735|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87736|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87737|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87738|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87739|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87740|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87741|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87742|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87743|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87906|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87744|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87745|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87746|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87747|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87748|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87749|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87750|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87751|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87752|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87753|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87754|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87755|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87756|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87757|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87758|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87759|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87760|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87761|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87762|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87763|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87764|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87907|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
87765|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87766|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87767|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87768|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
88041|NCT01853072|E2|Reported Event|Nepafenac|All participants treated with Nepafenac during the course of study treatment
87769|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87770|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87771|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87772|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87773|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87774|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87775|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87776|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87777|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87778|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87779|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87780|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87781|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87782|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87783|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87784|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87785|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87786|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87787|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87788|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87789|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
88536|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
87790|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87791|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87792|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87793|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87794|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87795|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87796|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87797|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87798|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87799|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87800|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87801|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87802|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87803|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87804|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87805|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87853|NCT01853982|E2|Reported Event|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
89820|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
87806|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87807|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87808|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87809|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87810|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
88042|NCT01853072|E1|Reported Event|Pretreatment|All participants who consented to participate in the study prior to the initiation of study treatment
87811|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87812|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87813|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87814|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87815|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87816|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87817|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87818|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87819|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87820|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87821|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87822|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87823|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87824|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87825|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87854|NCT01853982|E1|Reported Event|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
87855|NCT01853696|B3|Baseline|Total|Total of all reporting groups
87826|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87827|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87828|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87829|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87830|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87831|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
88043|NCT01853046|B3|Baseline|Total|Total of all reporting groups
87832|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87833|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87834|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87835|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87836|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87837|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87838|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87839|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87840|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
87841|NCT01854047|E5|Reported Event|Dupilumab 200 mg q4w|Participants exposed to Dupilumab 200 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
87842|NCT01854047|E4|Reported Event|Dupilumab 300 mg q4w|Participants exposed to Dupilumab 300 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
87843|NCT01854047|E3|Reported Event|Dupilumab 200 mg q2w|Participants exposed to Dupilumab 200 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
87844|NCT01854047|E2|Reported Event|Dupilumab 300 mg q2w|Participants exposed to Dupilumab 300 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
87845|NCT01854047|E1|Reported Event|Placebo|Participants exposed to Placebo (for Dupilumab) added to stable ICS/LABA therapy (mean exposure of 23 weeks).
87846|NCT01853982|B3|Baseline|Total|Total of all reporting groups
87847|NCT01853982|B2|Baseline|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
87848|NCT01853982|B1|Baseline|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
87849|NCT01853982|P2|Participant Flow|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
87850|NCT01853982|P1|Participant Flow|Ceftolozane/Tazobactam|3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
87851|NCT01853982|O2|Outcome|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
87856|NCT01853696|B2|Baseline|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months
prednisolone acetate 1%"
87857|NCT01853696|B1|Baseline|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months
loteprednol etabonate"
87858|NCT01853696|P2|Participant Flow|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months
prednisolone acetate 1%"
87859|NCT01853696|P1|Participant Flow|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months
loteprednol etabonate 0.5% gel"
87860|NCT01853696|O2|Outcome|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months
prednisolone acetate 1%"
87861|NCT01853696|O1|Outcome|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months
loteprednol etabonate 0.5% gel"
88139|NCT01852812|B4|Baseline|Total|Total of all reporting groups
87864|NCT01853696|E2|Reported Event|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months
prednisolone acetate 1%"
87865|NCT01853696|E1|Reported Event|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months
loteprednol etabonate 0.5% gel"
87866|NCT01853605|B5|Baseline|Total|Total of all reporting groups
87867|NCT01853605|B4|Baseline|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
87868|NCT01853605|B3|Baseline|Reconstruction|Women undergoing breast reconstruction.
87869|NCT01853605|B2|Baseline|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
87870|NCT01853605|B1|Baseline|Augmentation|Women undergoing breast augmentation.
87871|NCT01853605|P4|Participant Flow|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
87872|NCT01853605|P3|Participant Flow|Reconstruction|Women undergoing breast reconstruction.
87873|NCT01853605|P2|Participant Flow|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
87874|NCT01853605|P1|Participant Flow|Augmentation|Women undergoing breast augmentation.
87875|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
87876|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
87877|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
87878|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
87879|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
87880|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
87881|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
87882|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
87883|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
87884|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
87885|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
87886|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
87887|NCT01853605|E4|Reported Event|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
87888|NCT01853605|E3|Reported Event|Reconstruction|Women undergoing breast reconstruction.
87889|NCT01853605|E2|Reported Event|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
87890|NCT01853605|E1|Reported Event|Augmentation|Women undergoing breast augmentation.
87891|NCT01853475|B4|Baseline|Total|Total of all reporting groups
87892|NCT01853475|B3|Baseline|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
87893|NCT01853475|B2|Baseline|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87894|NCT01853475|B1|Baseline|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87895|NCT01853475|P3|Participant Flow|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
87896|NCT01853475|P2|Participant Flow|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87897|NCT01853475|P1|Participant Flow|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87898|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
87899|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87900|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87901|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
87902|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87903|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87904|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
87905|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87908|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87909|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87910|NCT01853475|E3|Reported Event|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
87911|NCT01853475|E2|Reported Event|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87912|NCT01853475|E1|Reported Event|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
87913|NCT01853397|B5|Baseline|Total|Total of all reporting groups
87914|NCT01853397|B4|Baseline|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)
Liposonix System (Model 2)"
89811|NCT01843348|B1|Baseline|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
87915|NCT01853397|B3|Baseline|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)"
87916|NCT01853397|B2|Baseline|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)"
87917|NCT01853397|B1|Baseline|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)"
87918|NCT01853397|P4|Participant Flow|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)
Liposonix System (Model 2)"
87919|NCT01853397|P3|Participant Flow|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)"
87920|NCT01853397|P2|Participant Flow|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)"
87921|NCT01853397|P1|Participant Flow|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)"
87922|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)
Liposonix System (Model 2)"
87923|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)"
87924|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)"
87925|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)"
87926|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)
Liposonix System (Model 2)"
87927|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)"
87928|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)"
87929|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)"
87930|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)
Liposonix System (Model 2)"
87931|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)"
87932|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)"
87933|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)"
87934|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)
Liposonix System (Model 2)"
87935|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)"
87936|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)"
87937|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)"
87938|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)
Liposonix System (Model 2)"
87939|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)"
87940|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)"
87941|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)"
87942|NCT01853397|E4|Reported Event|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)
Liposonix System (Model 2)"
87943|NCT01853397|E3|Reported Event|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Liposonix System (Model 2)"
87944|NCT01853397|E2|Reported Event|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)"
87945|NCT01853397|E1|Reported Event|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Liposonix System (Model 2)"
87946|NCT01853384|B3|Baseline|Total|Total of all reporting groups
87947|NCT01853384|B2|Baseline|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
87948|NCT01853384|B1|Baseline|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
87949|NCT01853384|P2|Participant Flow|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
87950|NCT01853384|P1|Participant Flow|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
87951|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
87952|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
87953|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
87954|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
87955|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
87956|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
87957|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
87958|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
87959|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
87960|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
87961|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
87999|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.
T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
88537|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
87962|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
87963|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
87964|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
87965|NCT01853384|E2|Reported Event|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
87966|NCT01853384|E1|Reported Event|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
87967|NCT01853371|B3|Baseline|Total|Total of all reporting groups
87968|NCT01853371|B2|Baseline|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
87969|NCT01853371|B1|Baseline|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.
Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
87970|NCT01853371|P2|Participant Flow|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
87971|NCT01853371|P1|Participant Flow|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other. The wet cupping procedure was not done on certain days of the lunar month.
Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
88171|NCT01851876|E2|Reported Event|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
87972|NCT01853371|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
87973|NCT01853371|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.
Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
88000|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.
T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum"
87974|NCT01853371|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
87975|NCT01853371|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.
Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
87976|NCT01853371|E2|Reported Event|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
87977|NCT01853371|E1|Reported Event|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.
Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
87978|NCT01853332|B1|Baseline|Cross-Sectional|New and Former Participants
87979|NCT01853332|P1|Participant Flow|Cross-Sectional|"New participants: The purpose of the study is to learn about physical health in midlife and how it has been influenced by experiences and relationships. The study specifically targets health differences and the development of heart disease and diabetes.
AND
Former participants (or the partner of a former participant) of the Adolescent and Family Development Project, Young Adult Development Project, Across Generations Project, and/or Paths Over Time Project may already know that this research shows how people grow, individually and as part of a familial and social network, throughout the course of life. This study focuses on learning about former participants' physical health in midlife and how it has been influenced by their experiences and relationships."
87980|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants studied cross-sectionally.
87981|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants studied cross-sectionally.
87982|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants studied cross-sectionally.
87983|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants studied cross-sectionally.
87984|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants studied cross-sectionally.
87985|NCT01853332|O1|Outcome|Cross-Sectional|New participants and former participants
87986|NCT01853332|E1|Reported Event|Cross-Sectional|New and Former Participants
87987|NCT01853254|B1|Baseline|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
87988|NCT01853254|P1|Participant Flow|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
87989|NCT01853254|O1|Outcome|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
87990|NCT01853254|E1|Reported Event|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
88172|NCT01851876|E1|Reported Event|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
87991|NCT01853215|B1|Baseline|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set
T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum"
87992|NCT01853215|P1|Participant Flow|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.
T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
87993|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.
T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
87994|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.
T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
87995|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.
T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
87996|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.
T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
87997|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.
T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum"
87998|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.
T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
88037|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
88001|NCT01853215|E1|Reported Event|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set
T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum"
88002|NCT01853176|B3|Baseline|Total|Total of all reporting groups
88003|NCT01853176|B2|Baseline|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Standard bupivicaine"
88004|NCT01853176|B1|Baseline|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Liposomal Injection Bupivacaine (Exparel)"
88005|NCT01853176|P2|Participant Flow|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Standard bupivicaine"
88006|NCT01853176|P1|Participant Flow|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Liposomal Injection Bupivacaine (Exparel)"
88007|NCT01853176|O2|Outcome|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Standard bupivicaine"
88008|NCT01853176|O1|Outcome|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Liposomal Injection Bupivacaine (Exparel)"
88009|NCT01853176|E2|Reported Event|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Standard bupivicaine"
88010|NCT01853176|E1|Reported Event|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Liposomal Injection Bupivacaine (Exparel)"
88011|NCT01853085|B1|Baseline|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
88012|NCT01853085|P1|Participant Flow|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
88013|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
88014|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
88015|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
88016|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
88017|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
88018|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
88019|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
88106|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.
IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
88020|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
88021|NCT01853085|E1|Reported Event|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
88022|NCT01853072|B3|Baseline|Total|Total of all reporting groups
88023|NCT01853072|B2|Baseline|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
88024|NCT01853072|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
88025|NCT01853072|P2|Participant Flow|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
88026|NCT01853072|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
88027|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
88028|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
88029|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
88030|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
88031|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
88032|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
88033|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
88034|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
88035|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
88036|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
88044|NCT01853046|B2|Baseline|Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88045|NCT01853046|B1|Baseline|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88046|NCT01853046|P2|Participant Flow|Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88047|NCT01853046|P1|Participant Flow|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88048|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88049|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88050|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88051|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88052|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88053|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88054|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88107|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen
Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
88173|NCT01851863|B5|Baseline|Total|Total of all reporting groups
88055|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88056|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88057|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88058|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88059|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88140|NCT01852812|B3|Baseline|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88060|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88061|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88062|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88063|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88064|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88065|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88066|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88067|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88068|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88069|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88070|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88071|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88072|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88073|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88074|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88075|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88141|NCT01852812|B2|Baseline|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88076|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88077|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88078|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88079|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88080|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88081|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88082|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88083|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88084|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88085|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88086|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88087|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88088|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88089|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days
88090|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88091|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88142|NCT01852812|B1|Baseline|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
88092|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88093|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88094|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88095|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88096|NCT01853046|E2|Reported Event|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88097|NCT01853046|E1|Reported Event|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
88098|NCT01852955|B3|Baseline|Total|Total of all reporting groups
88099|NCT01852955|B2|Baseline|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen
Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
88100|NCT01852955|B1|Baseline|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.
IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
88101|NCT01852955|P2|Participant Flow|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen
Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
88102|NCT01852955|P1|Participant Flow|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.
IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
88103|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen
Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
88104|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.
IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
88105|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen
Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
88108|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.
IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
88109|NCT01852955|E2|Reported Event|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen
Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
88110|NCT01852955|E1|Reported Event|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.
IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
88111|NCT01852825|B4|Baseline|Total|Total of all reporting groups
88112|NCT01852825|B3|Baseline|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
88113|NCT01852825|B2|Baseline|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88114|NCT01852825|B1|Baseline|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88252|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
88115|NCT01852825|P3|Participant Flow|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
88116|NCT01852825|P2|Participant Flow|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88117|NCT01852825|P1|Participant Flow|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88118|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
88119|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88120|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88121|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
88122|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88123|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88124|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
88125|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88126|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88127|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
88128|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88129|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88130|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
88131|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88170|NCT01851876|O1|Outcome|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
88236|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
88132|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88133|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
88134|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88135|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88136|NCT01852825|E3|Reported Event|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88137|NCT01852825|E2|Reported Event|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
88138|NCT01852825|E1|Reported Event|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
88143|NCT01852812|P3|Participant Flow|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88144|NCT01852812|P2|Participant Flow|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg chewable tablets (CT) in one tablet PO QD at bed time for 12 weeks
88145|NCT01852812|P1|Participant Flow|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg oral granules (OG) in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
88146|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88147|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88148|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
88149|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88150|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88151|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
88152|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88153|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88154|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
88155|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88156|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88157|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
88158|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88159|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
88160|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88161|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
88162|NCT01852812|E2|Reported Event|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
88163|NCT01852812|E1|Reported Event|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
88164|NCT01851876|B3|Baseline|Total|Total of all reporting groups
88165|NCT01851876|B2|Baseline|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
88166|NCT01851876|B1|Baseline|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
88167|NCT01851876|P2|Participant Flow|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
88168|NCT01851876|P1|Participant Flow|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
88169|NCT01851876|O2|Outcome|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
88174|NCT01851863|B4|Baseline|Proton Pump Inhibitor|"Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
88175|NCT01851863|B3|Baseline|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
88176|NCT01851863|B2|Baseline|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
88177|NCT01851863|B1|Baseline|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
88178|NCT01851863|P4|Participant Flow|Proton Pump Inhibitor|"Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
88179|NCT01851863|P3|Participant Flow|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
88180|NCT01851863|P2|Participant Flow|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
88181|NCT01851863|P1|Participant Flow|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
88182|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
88183|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
88184|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
88185|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
88186|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
88187|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
88188|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
88189|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
88190|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
88191|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
88192|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
88193|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole) .The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
88237|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
88238|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
88239|NCT01852214|O2|Outcome|Ticagrelor|Patients received a 180mg loading dose and 90mg bid maintenance dose
88194|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
88195|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
88196|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
88197|NCT01851863|E4|Reported Event|Proton Pump Inhibitor|"Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
88198|NCT01851863|E3|Reported Event|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
88199|NCT01851863|E2|Reported Event|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
88200|NCT01851863|E1|Reported Event|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
88201|NCT01851772|B1|Baseline|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
88202|NCT01851772|P1|Participant Flow|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
88203|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
88204|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
88205|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
88206|NCT01851772|E1|Reported Event|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
88207|NCT01852669|B3|Baseline|Total|Total of all reporting groups
88208|NCT01852669|B2|Baseline|ESWL, Hydration|"ESWL with hydration
Shock Wave Lithotripsy: Shock wave lithotripsy
Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
88209|NCT01852669|B1|Baseline|Inversion, Hydration, ESWL|"ESWL with hydration and inversion
Inversion: Patients inverted 30 degree head down in Trendelenburg position
Shock Wave Lithotripsy: Shock wave lithotripsy
Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
88210|NCT01852669|P2|Participant Flow|ESWL, Hydration|"ESWL with hydration
Shock Wave Lithotripsy: Shock wave lithotripsy
Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
88211|NCT01852669|P1|Participant Flow|Inversion, Hydration, ESWL|"ESWL with hydration and inversion
Inversion: Patients inverted 30 degree head down in Trendelenburg position
Shock Wave Lithotripsy: Shock wave lithotripsy
Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
88212|NCT01852669|O2|Outcome|ESWL, Hydration|"ESWL with hydration
Shock Wave Lithotripsy: Shock wave lithotripsy
Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
88213|NCT01852669|O1|Outcome|Inversion, Hydration, ESWL|"ESWL with hydration and inversion
Inversion: Patients inverted 30 degree head down in Trendelenburg position
Shock Wave Lithotripsy: Shock wave lithotripsy
Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
88214|NCT01852669|E2|Reported Event|ESWL, Hydration|"ESWL with hydration
Shock Wave Lithotripsy: Shock wave lithotripsy
Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
88215|NCT01852669|E1|Reported Event|Inversion, Hydration, ESWL|"ESWL with hydration and inversion
Inversion: Patients inverted 30 degree head down in Trendelenburg position
Shock Wave Lithotripsy: Shock wave lithotripsy
Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
88216|NCT01852591|B1|Baseline|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
88217|NCT01852591|P1|Participant Flow|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
88218|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
88219|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
88220|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
88221|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
88222|NCT01852591|E1|Reported Event|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
88240|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
88241|NCT01852214|E2|Reported Event|Safety Population: Patients Receiving Ticagrelor|Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
88223|NCT01852383|B1|Baseline|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.
At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.
Administration will be as a single a.m. dose."
88224|NCT01852383|P1|Participant Flow|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.
At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.
Administration will be as a single a.m. dose."
88253|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
88254|NCT01852175|E2|Reported Event|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
88255|NCT01852175|E1|Reported Event|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
88256|NCT01852162|B3|Baseline|Total|Total of all reporting groups
88257|NCT01852162|B2|Baseline|Placebo|Placebo tablets
88258|NCT01852162|B1|Baseline|Dabigatran|Dabigatran 150mg tablets
88259|NCT01852162|P2|Participant Flow|Placebo|Patients randomized to the placebo arm received matching placebo tablets twice/daily for 7 (±3) days.
88225|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.
At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects.
Administration was as a single a.m. dose.
Duloxetine: Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale, Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale."
88226|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.
At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects.
Administration was as a single a.m. dose.
Duloxetine: Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale, Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale."
88227|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.
At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.
Administration will be as a single a.m. dose."
88228|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.
At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.
Administration will be as a single a.m. dose."
88229|NCT01852383|E1|Reported Event|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.
At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.
Administration will be as a single a.m. dose."
88230|NCT01852214|B1|Baseline|Overall Population|Subjects with type 2 diabetes mellitus and coronary artery disease
88231|NCT01852214|P2|Participant Flow|Ticagrelor First, Then Prasugrel|"Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose
Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose"
88232|NCT01852214|P1|Participant Flow|Prasugrel First, Then Ticagrelor|"Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose
Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose"
88233|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
88234|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
88235|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
88242|NCT01852214|E1|Reported Event|Safety Population: Patients Receiving Prasugrel|Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
88243|NCT01852175|B3|Baseline|Total|Total of all reporting groups
88244|NCT01852175|B2|Baseline|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
88245|NCT01852175|B1|Baseline|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
88246|NCT01852175|P2|Participant Flow|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
88247|NCT01852175|P1|Participant Flow|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
88248|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
88249|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
88250|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
88251|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
88260|NCT01852162|P1|Participant Flow|Dabigatran|Patients randomized to the dabigatran arm received dabigatran 150mg twice/daily for 7 (±3) days.
88261|NCT01852162|O2|Outcome|Placebo|Placebo tablets
88262|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
88263|NCT01852162|O2|Outcome|Placebo|Placebo tablets
88264|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
88265|NCT01852162|O2|Outcome|Placebo|Placebo tablets
88266|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
88267|NCT01852162|O2|Outcome|Placebo|Placebo tablets
88268|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
88269|NCT01852162|O2|Outcome|Placebo|Placebo tablets
88270|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
88271|NCT01852162|E2|Reported Event|Placebo|Placebo tablets
88272|NCT01852162|E1|Reported Event|Dabigatran|Dabigatran 150mg tablets
88273|NCT01852019|B3|Baseline|Total|Total of all reporting groups
88274|NCT01852019|B2|Baseline|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel discontinued 48h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88275|NCT01852019|B1|Baseline|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88276|NCT01852019|P5|Participant Flow|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)
cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88277|NCT01852019|P4|Participant Flow|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)
cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88278|NCT01852019|P3|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.
cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88279|NCT01852019|P2|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.
cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88280|NCT01852019|P1|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion|"Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation
cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88281|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
89821|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
88282|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88283|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV iwas administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88299|NCT01851720|B2|Baseline|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes
No initial bolus and no continuous infusion
Demand dose increased 10 mcg every 12 minutes if necessary
Maximum dose of 100 mcg/hr
Low dose fentanyl PCA"
88284|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88285|NCT01852019|O3|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88286|NCT01852019|O2|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88287|NCT01852019|O1|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)|"Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88288|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV iwas administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88289|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88290|NCT01852019|O3|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88291|NCT01852019|O2|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88292|NCT01852019|O1|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)|"Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation
cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
88293|NCT01852019|E5|Reported Event|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)
Subjects were given 5 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8"
88338|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day
Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
88294|NCT01852019|E4|Reported Event|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)
Subjects were given 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8"
88295|NCT01852019|E3|Reported Event|Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr)|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) post infusion, [at 2.0 hrs, (within 5 minutes of discontinuing the cangrelor infusion)]."
88296|NCT01852019|E2|Reported Event|Day 1 - Prasugrel (60mg) at 1.0 hr|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.0 hour after infusion start)."
88297|NCT01852019|E1|Reported Event|Day 1 - Prasugrel (60mg) at 1.5 Hrs|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.5 hours after infusion start)."
88298|NCT01851720|B3|Baseline|Total|Total of all reporting groups
88538|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
88300|NCT01851720|B1|Baseline|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain
(Bolus dose can be titrated up in 25 mcg increments if necessary)
Maximum dose of 100 mcg/hr
Standard IV fentanyl bolus"
88301|NCT01851720|P2|Participant Flow|Low Dose IV Fentanyl Patient Controlled Analgesia (PCA)|"Initially: 10 mcg demand dose every 12 minutes
No initial bolus and no continuous infusion
Demand dose increased 10 mcg every 12 minutes if necessary
Maximum dose of 100 mcg/hr
Low dose fentanyl PCA"
88302|NCT01851720|P1|Participant Flow|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain
(Bolus dose can be titrated up in 25 mcg increments if necessary)
Maximum dose of 100 mcg/hr
Standard IV fentanyl bolus"
88303|NCT01851720|O2|Outcome|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes
No initial bolus and no continuous infusion
Demand dose increased 10 mcg every 12 minutes if necessary
Maximum dose of 100 mcg/hr
Low dose fentanyl PCA"
88304|NCT01851720|O1|Outcome|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain
(Bolus dose can be titrated up in 25 mcg increments if necessary)
Maximum dose of 100 mcg/hr
Standard IV fentanyl bolus"
88305|NCT01851720|E2|Reported Event|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes
No initial bolus and no continuous infusion
Demand dose increased 10 mcg every 12 minutes if necessary
Maximum dose of 100 mcg/hr
Low dose fentanyl PCA"
88306|NCT01851720|E1|Reported Event|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain
(Bolus dose can be titrated up in 25 mcg increments if necessary)
Maximum dose of 100 mcg/hr
Standard IV fentanyl bolus"
88307|NCT01851655|B3|Baseline|Total|Total of all reporting groups
88308|NCT01851655|B2|Baseline|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88309|NCT01851655|B1|Baseline|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88310|NCT01851655|P2|Participant Flow|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88311|NCT01851655|P1|Participant Flow|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88312|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88313|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88314|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88539|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88315|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88316|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88317|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88318|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88319|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88320|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88321|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88339|NCT01851590|O2|Outcome|Amorolfine Treatment Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)
Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
88388|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88322|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88323|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88347|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg Terbinafine / day
Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
88348|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)
Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
88540|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88324|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88325|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88326|NCT01851655|E2|Reported Event|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88327|NCT01851655|E1|Reported Event|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).
Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
88328|NCT01851590|B4|Baseline|Total|Total of all reporting groups
88329|NCT01851590|B3|Baseline|Terbinafine Arm|"Oral medication with 250 mg Terbinafine / day
Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
88330|NCT01851590|B2|Baseline|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)
Amorolfine Lacquer is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
88331|NCT01851590|B1|Baseline|Resin Lacquer Arm|"Topical treatment: 30 % Resin Lacquer (Abicin®)
Resin Lacquer is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
88332|NCT01851590|P3|Participant Flow|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day
Terbinafine: Terbinafine 250 mg was administered orally once a day for 3 months in toenail onychomycosis."
88333|NCT01851590|P2|Participant Flow|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)
Amorolfine: Amorolfine was administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
88334|NCT01851590|P1|Participant Flow|Resin Lacquer Arm|"Topical treatment: 30 % Resin Lacquer (Abicin®)
Resin Lacquer was administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
88335|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day
Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
88336|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)
Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
88337|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)
Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
88340|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)
Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
88341|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day
Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
88342|NCT01851590|O2|Outcome|Amorolfine Treatment Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)
Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
88343|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)
Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
88344|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day
Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
88345|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)
Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
88346|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)
Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
88349|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % Resin Lacquer (Abicin®)
Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
88350|NCT01851590|E3|Reported Event|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day
Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
88351|NCT01851590|E2|Reported Event|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)
Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
88352|NCT01851590|E1|Reported Event|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)
Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
88353|NCT01851330|B4|Baseline|Total|Total of all reporting groups
88354|NCT01851330|B3|Baseline|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88355|NCT01851330|B2|Baseline|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88356|NCT01851330|B1|Baseline|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
88357|NCT01851330|P3|Participant Flow|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88358|NCT01851330|P2|Participant Flow|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88359|NCT01851330|P1|Participant Flow|LDV/SOF 8 Week|Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 8 weeks
88360|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88361|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88362|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
88363|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88364|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88365|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
88366|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88367|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88368|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
88369|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88370|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88371|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
88372|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88373|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88374|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
88375|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88376|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88377|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
88378|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88379|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88380|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
88381|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88382|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88383|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
88384|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88385|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88386|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
88387|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
88391|NCT01851330|E2|Reported Event|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
88392|NCT01851330|E1|Reported Event|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
88393|NCT01849588|B1|Baseline|Sorafenib|"Sorafenib taken orally twice per day
Sorafenib"
88394|NCT01849588|P1|Participant Flow|Sorafenib|"Sorafenib taken orally twice per day
Sorafenib"
88395|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day
Sorafenib"
88396|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day
Sorafenib"
88397|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day
Sorafenib"
88398|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day
Sorafenib"
88399|NCT01849588|E1|Reported Event|Sorafenib|"Sorafenib taken orally twice per day
Sorafenib"
88400|NCT01849562|B4|Baseline|Total|Total of all reporting groups
88401|NCT01849562|B3|Baseline|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks
Placebo"
88402|NCT01849562|B2|Baseline|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Sovaprevir: NS3/4A protease inhibitor
ACH-3102: NS5A inhibitor
Ribavirin"
88403|NCT01849562|B1|Baseline|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Sovaprevir: NS3/4A protease inhibitor
ACH-3102: NS5A inhibitor
Ribavirin"
88404|NCT01849562|P3|Participant Flow|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks
Placebo"
88405|NCT01849562|P2|Participant Flow|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Sovaprevir: NS3/4A protease inhibitor
ACH-3102: NS5A inhibitor
Ribavirin"
88406|NCT01849562|P1|Participant Flow|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Sovaprevir: NS3/4A protease inhibitor
ACH-3102: NS5A inhibitor
Ribavirin"
88407|NCT01849562|O3|Outcome|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks
Placebo"
88408|NCT01849562|O2|Outcome|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-2000mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Sovaprevir: NS3/4A protease inhibitor
ACH-3102: NS5A inhibitor
Ribavirin"
88409|NCT01849562|O1|Outcome|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Sovaprevir: NS3/4A protease inhibitor
ACH-3102: NS5A inhibitor
Ribavirin"
88410|NCT01849562|O3|Outcome|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks
Placebo"
88411|NCT01849562|O2|Outcome|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Sovaprevir: NS3/4A protease inhibitor
ACH-3102: NS5A inhibitor
Ribavirin"
88412|NCT01849562|O1|Outcome|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Sovaprevir: NS3/4A protease inhibitor
ACH-3102: NS5A inhibitor
Ribavirin"
88413|NCT01849562|E3|Reported Event|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks
Placebo"
88414|NCT01849562|E2|Reported Event|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Sovaprevir: NS3/4A protease inhibitor
ACH-3102: NS5A inhibitor
Ribavirin"
88415|NCT01849562|E1|Reported Event|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Sovaprevir: NS3/4A protease inhibitor
ACH-3102: NS5A inhibitor
Ribavirin"
88416|NCT01849497|B3|Baseline|Total|Total of all reporting groups
88417|NCT01849497|B2|Baseline|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
88418|NCT01849497|B1|Baseline|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
88419|NCT01849497|P2|Participant Flow|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4.
88420|NCT01849497|P1|Participant Flow|Evolocumab PFS|"Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4."
88421|NCT01849497|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
88422|NCT01849497|O1|Outcome|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
88423|NCT01849497|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
88424|NCT01849497|O1|Outcome|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
88524|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88425|NCT01849497|E2|Reported Event|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
88426|NCT01849497|E1|Reported Event|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
88427|NCT01850589|B3|Baseline|Total|Total of all reporting groups
88442|NCT01850550|O1|Outcome|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
88443|NCT01850550|O2|Outcome|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.
Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
88428|NCT01850589|B2|Baseline|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:
One hour group counseling sessions, focusing on patient education and behavior modification.
Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.
Counseling including information on nutrition, exercise, and chemical dependency.
Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.
Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:
Chantix (varenicline) GlaxoSmithKline,
Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
88429|NCT01850589|B1|Baseline|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
88430|NCT01850589|P2|Participant Flow|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:
8 one hour group counseling sessions focusing on patient education and behavior modification.
Behavior modifications include cue recognition; coping skills; stress management; and relapse prevention skills.
Counseling includes information on nutrition, exercise, and chemical dependency.
All counseling sessions will be held at 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows:
Chantix (varenicline) GlaxoSmithKline,
Zyban (bupropion) Pfizer
Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
88431|NCT01850589|P1|Participant Flow|Conserative Therapy|"Patients will be counseled by the vascular attending/fellow during their office appointment to stop smoking. Counseling will consist of a self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
88432|NCT01850589|O2|Outcome|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:
One hour group counseling sessions, focusing on patient education and behavior modification.
Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.
Counseling including information on nutrition, exercise, and chemical dependency.
Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.
Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:
Chantix (varenicline) GlaxoSmithKline,
Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
88433|NCT01850589|O1|Outcome|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
88434|NCT01850589|E2|Reported Event|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:
One hour group counseling sessions, focusing on patient education and behavior modification.
Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.
Counseling including information on nutrition, exercise, and chemical dependency.
Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.
Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:
Chantix (varenicline) GlaxoSmithKline,
Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
88435|NCT01850589|E1|Reported Event|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
88436|NCT01850550|B3|Baseline|Total|Total of all reporting groups
88437|NCT01850550|B2|Baseline|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.
Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
88465|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88438|NCT01850550|B1|Baseline|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
88439|NCT01850550|P2|Participant Flow|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.
Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
88440|NCT01850550|P1|Participant Flow|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
88441|NCT01850550|O2|Outcome|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.
Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
88444|NCT01850550|O1|Outcome|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
88445|NCT01850550|E2|Reported Event|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.
Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
88446|NCT01850550|E1|Reported Event|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
88447|NCT01850485|B3|Baseline|Total|Total of all reporting groups
88448|NCT01850485|B2|Baseline|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88449|NCT01850485|B1|Baseline|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88450|NCT01850485|P2|Participant Flow|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88451|NCT01850485|P1|Participant Flow|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88452|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88453|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88454|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88455|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88456|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88457|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88458|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88459|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88460|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88461|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88462|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88463|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88464|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88523|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
88466|NCT01850485|E2|Reported Event|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88467|NCT01850485|E1|Reported Event|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees
microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
88468|NCT01850394|B4|Baseline|Total|Total of all reporting groups
88469|NCT01850394|B3|Baseline|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88470|NCT01850394|B2|Baseline|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88471|NCT01850394|B1|Baseline|Control Group|"physiologic saline 25 ml
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
88472|NCT01850394|P3|Participant Flow|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88473|NCT01850394|P2|Participant Flow|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88474|NCT01850394|P1|Participant Flow|Control Group|"physiologic saline 25 ml
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
88475|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88476|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88477|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
88478|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88479|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88480|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
88481|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88482|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88483|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
88484|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88485|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88486|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
88487|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88488|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88489|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
88490|NCT01850394|E3|Reported Event|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88491|NCT01850394|E2|Reported Event|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
88492|NCT01850394|E1|Reported Event|Control Group|"physiologic saline 25 ml
Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
88493|NCT01849848|B1|Baseline|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88494|NCT01849848|P1|Participant Flow|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88495|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88496|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88534|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88497|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88498|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88499|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88500|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88501|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88502|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88503|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88504|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88505|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88506|NCT01849848|E1|Reported Event|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
88507|NCT01849770|B4|Baseline|Total|Total of all reporting groups
88508|NCT01849770|B3|Baseline|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
88509|NCT01849770|B2|Baseline|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88510|NCT01849770|B1|Baseline|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88511|NCT01849770|P3|Participant Flow|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
88512|NCT01849770|P2|Participant Flow|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88513|NCT01849770|P1|Participant Flow|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88514|NCT01849770|O2|Outcome|900mg vs Placebo|
88515|NCT01849770|O1|Outcome|300mg vs Placebo|
88516|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
88517|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88518|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88519|NCT01849770|O2|Outcome|900mg vs Placebo|
88520|NCT01849770|O1|Outcome|300mg vs Placebo|
88521|NCT01849770|O2|Outcome|900mg vs Placebo|
88522|NCT01849770|O1|Outcome|300mg vs Placebo|
88525|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88526|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
88527|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88528|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88529|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
88530|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88531|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88532|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
88533|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88542|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88543|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88544|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
88545|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88546|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88547|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
88548|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88549|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88550|NCT01849770|E3|Reported Event|Placebo|"Placebo, by mouth per day for 12 weeks.
Placebo"
88551|NCT01849770|E2|Reported Event|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.
Mexiletine"
88552|NCT01849770|E1|Reported Event|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.
Mexiletine"
88553|NCT01849692|B3|Baseline|Total|Total of all reporting groups
88554|NCT01849692|B2|Baseline|LUCENTIS|All subjects who were treated with LUCENTIS.
88555|NCT01849692|B1|Baseline|ESBA|All subjects who were treated with ESBA1008.
88556|NCT01849692|P8|Participant Flow|Cohort 4 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
88557|NCT01849692|P7|Participant Flow|Cohort 4 - ESBA|ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg)
88558|NCT01849692|P6|Participant Flow|Cohort 3 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
88559|NCT01849692|P5|Participant Flow|Cohort 3 - ESBA|ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg)
88560|NCT01849692|P4|Participant Flow|Cohort 2 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
88561|NCT01849692|P3|Participant Flow|Cohort 2 - ESBA|ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg)
88562|NCT01849692|P2|Participant Flow|Cohort 1 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
88563|NCT01849692|P1|Participant Flow|Cohort 1 - ESBA|ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg)
88564|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
88565|NCT01849692|O1|Outcome|ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg IVT infusion
88566|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
88567|NCT01849692|O1|Outcome|ESBA 0.6 mg INJ|All subjects treated with ESBA1008 0.6 mg IVT injection
88568|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
88569|NCT01849692|O1|Outcome|ESBA 1 mg INF|All subjects treated with ESBA1008 1 mg IVT infusion
88570|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
88571|NCT01849692|O1|Outcome|ESBA 1.2 mg INJ|All subjects treated with ESBA1008 1.2 mg IVT injection
88572|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
88573|NCT01849692|O1|Outcome|ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg IVT infusion
88574|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
88575|NCT01849692|O1|Outcome|ESBA 0.6 mg INJ|All subjects treated with ESBA 1008 0.6 mg IVT injection
88576|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
88577|NCT01849692|O1|Outcome|ESBA 1 mg INF|All subjects treated with ESBA 1008 1 mg IVT infusion
88578|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
88579|NCT01849692|O1|Outcome|ESBA 1.2 mg INJ|All subjects treated with ESBA 1008 1.2 mg IVT injection
88580|NCT01849692|O4|Outcome|Cohort 4|ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
88581|NCT01849692|O3|Outcome|Cohort 3|ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
88582|NCT01849692|O2|Outcome|Cohort 2|ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
88583|NCT01849692|O1|Outcome|Cohort 1|ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
88584|NCT01849692|E7|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
88585|NCT01849692|E6|Reported Event|Stage 2 LUCENTIS 0.5 mg INJ|All subjects treated with LUCENTIS via injection in Stage 2
88586|NCT01849692|E5|Reported Event|Stage 2 ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg via infusion
88587|NCT01849692|E4|Reported Event|Stage 2 ESBA 0.6 mg INJ|All subjects treated with ESBA1008 0.6 mg via injection
88588|NCT01849692|E3|Reported Event|Stage 1 LUCENTIS 0.5 mg INJ|All subjects treated with LUCENTIS via injection in Stage 1
88589|NCT01849692|E2|Reported Event|Stage 1 ESBA 1 mg INF|All subjects treated with ESBA1008 1 mg via infusion
88590|NCT01849692|E1|Reported Event|Stage 1 ESBA 1.2 mg INJ|All subjects treated with ESBA1008 1.2 mg via injection
88591|NCT01849458|B1|Baseline|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
88592|NCT01849458|P1|Participant Flow|BioFiber Scaffold|Single arm of subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
88593|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
88594|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
88595|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
88596|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
88597|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
88598|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
88599|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
88600|NCT01849458|E1|Reported Event|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
88601|NCT01849419|B1|Baseline|Single Group|"Healthy volunteers received all drug conditions including placebo (within-subjects design).
Within-subjects (MDMA and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg)and placebo. Participants received oxytocin as an active control on one session (see second Intervention).
Within-subjects (oxytocin and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session and placebo on one session. Participants received MDMA on the other two sessions (see first Intervention)."
88602|NCT01849419|P1|Participant Flow|Single Group|"Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg), oxytocin (20 IU), and placebo over the course of four experimental sessions. Drug order was randomized for each participant."
88603|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88604|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88605|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88606|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88607|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88608|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88609|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88610|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88611|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88612|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88613|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88614|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88615|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88616|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88617|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88618|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88619|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88620|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88621|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88622|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88623|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
88624|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
88625|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
88626|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
88627|NCT01849419|E1|Reported Event|Single Group|"Healthy volunteers received all drug conditions including placebo (within-subjects design).
Within-subjects (MDMA and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg)and placebo. Participants received oxytocin as an active control on one session (see second Intervention).
Within-subjects (oxytocin and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session and placebo on one session. Participants received MDMA on the other two sessions (see first Intervention)."
88628|NCT01849289|B3|Baseline|Total|Total of all reporting groups
88629|NCT01849289|B2|Baseline|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88630|NCT01849289|B1|Baseline|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88649|NCT01849068|B1|Baseline|Ezetimibe First Then Placebo|First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo 12 weeks
88650|NCT01849068|P2|Participant Flow|Placebo First, Then Ezetimibe|First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 10 mg/d for 12 weeks
88631|NCT01849289|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88632|NCT01849289|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88633|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88634|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88635|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88636|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88637|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88638|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88639|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88640|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88641|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88642|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88643|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88734|NCT01848847|O2|Outcome|Full Bladder|"Hysteroscopy conducted under full bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
88735|NCT01848847|O1|Outcome|Empty Bladder|"Hysteroscopy conducted under empty bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
88644|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88645|NCT01849289|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88646|NCT01849289|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
88647|NCT01849068|B3|Baseline|Total|Total of all reporting groups
88648|NCT01849068|B2|Baseline|Placebo First Then Ezetimibe|First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 12 weeks
88651|NCT01849068|P1|Participant Flow|Ezetimibe First, Then Placebo|First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo for 12 weeks
88652|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
88653|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
88654|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
88655|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
88656|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
88657|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
88658|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
88659|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
88660|NCT01849068|E2|Reported Event|Placebo|Placebo for 12 weeks Placebo for 12 weeks
88661|NCT01849068|E1|Reported Event|Ezetimibe|Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
88662|NCT01848990|B4|Baseline|Total|Total of all reporting groups
88663|NCT01848990|B3|Baseline|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
88664|NCT01848990|B2|Baseline|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
88665|NCT01848990|B1|Baseline|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
88666|NCT01848990|P3|Participant Flow|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
88667|NCT01848990|P2|Participant Flow|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
88668|NCT01848990|P1|Participant Flow|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous subcutaneous insulin infusion (CSII) (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 units (U) through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
88669|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
88670|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
88671|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
88672|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
88673|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
88736|NCT01848847|E2|Reported Event|Full Bladder|"Hysteroscopy conducted under full bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
88674|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
88675|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
88676|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
88677|NCT01848990|O2|Outcome|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
88700|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
88874|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88875|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88678|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
88679|NCT01848990|E3|Reported Event|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
88680|NCT01848990|E2|Reported Event|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
88681|NCT01848990|E1|Reported Event|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
88682|NCT01848977|B1|Baseline|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.
Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
88683|NCT01848977|P1|Participant Flow|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.
Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
88684|NCT01848977|O2|Outcome|InSpectra™|Data from InSpectra™ during VOT were manually recorded. Reactive hyperemic area were calculated and compared to INVOS®.
88685|NCT01848977|O1|Outcome|INVOS®|Data from INVOS® during VOT were manually recorded. Reactive hyperemic area were calculated and compared to InSpectra™ .
88686|NCT01848977|O2|Outcome|InSpectra™|Basline value before VOT,and minimum/ maximum values of InSpectra™ were obtained and compared to INVOS®.
88687|NCT01848977|O1|Outcome|INVOS®|Basline value before VOT,and minimum/ maximum values of INVOS® were obtained and compared to InSpectra™ .
88688|NCT01848977|O2|Outcome|InSpectra™|Data from InSpectra™ during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to INVOS®.
88689|NCT01848977|O1|Outcome|INVOS®|Data from INVOS® during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to InSpectra™ .
88690|NCT01848977|E1|Reported Event|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.
Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
88691|NCT01848938|B3|Baseline|Total|Total of all reporting groups
88692|NCT01848938|B2|Baseline|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
88737|NCT01848847|E1|Reported Event|Empty Bladder|"Hysteroscopy conducted under empty bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
88693|NCT01848938|B1|Baseline|Smartphone Treatment|"Smartphone treatment with pelvic floor muscle training (PFMT).
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
88694|NCT01848938|P2|Participant Flow|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
88695|NCT01848938|P1|Participant Flow|Smartphone Treatment|"Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
88696|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
88697|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
88698|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
88699|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
88701|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
88702|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
88703|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
88704|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
88705|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
88706|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
88707|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
88708|NCT01848938|E2|Reported Event|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
88709|NCT01848938|E1|Reported Event|Smartphone Treatment|"Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
88710|NCT01848899|B3|Baseline|Total|Total of all reporting groups
88711|NCT01848899|B2|Baseline|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
88712|NCT01848899|B1|Baseline|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
88713|NCT01848899|P2|Participant Flow|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
88714|NCT01848899|P1|Participant Flow|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
88715|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
88716|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
88717|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
88718|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
88719|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
88720|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
88721|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
88722|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
88723|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
88724|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
88725|NCT01848899|E2|Reported Event|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
88726|NCT01848899|E1|Reported Event|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
88727|NCT01848847|B3|Baseline|Total|Total of all reporting groups
88728|NCT01848847|B2|Baseline|Full Bladder|"Hysteroscopy conducted under full bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
88729|NCT01848847|B1|Baseline|Empty Bladder|"Hysteroscopy conducted under empty bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
88730|NCT01848847|P2|Participant Flow|Full Bladder|"Hysteroscopy conducted under full bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
88731|NCT01848847|P1|Participant Flow|Empty Bladder|"Hysteroscopy conducted under empty bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
88732|NCT01848847|O2|Outcome|Full Bladder|"Hysteroscopy conducted under full bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
88733|NCT01848847|O1|Outcome|Empty Bladder|"Hysteroscopy conducted under empty bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
88739|NCT01848834|B5|Baseline|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88740|NCT01848834|B4|Baseline|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88865|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88741|NCT01848834|B3|Baseline|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88742|NCT01848834|B2|Baseline|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88743|NCT01848834|B1|Baseline|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88744|NCT01848834|P5|Participant Flow|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88745|NCT01848834|P4|Participant Flow|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88746|NCT01848834|P3|Participant Flow|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88747|NCT01848834|P2|Participant Flow|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88748|NCT01848834|P1|Participant Flow|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88749|NCT01848834|O5|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88750|NCT01848834|O4|Outcome|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88751|NCT01848834|O3|Outcome|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88752|NCT01848834|O2|Outcome|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88753|NCT01848834|O1|Outcome|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88812|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
88813|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
88754|NCT01848834|O1|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88755|NCT01848834|O4|Outcome|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88756|NCT01848834|O3|Outcome|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88757|NCT01848834|O2|Outcome|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88758|NCT01848834|O1|Outcome|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88759|NCT01848834|O1|Outcome|Cohorts B & B2: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks (Cohort B) or pembrolizumab, 200 mg, IV once every 3 weeks (Cohort B2), and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88760|NCT01848834|O1|Outcome|Cohort D: Gastric Cancer AP Participants|Participants who were from the Asia Pacific region received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88761|NCT01848834|O1|Outcome|Cohorts B & B2: Head & Neck Cancer HPV-positive Participants|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks or pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88762|NCT01848834|O1|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88763|NCT01848834|O4|Outcome|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88764|NCT01848834|O3|Outcome|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88765|NCT01848834|O2|Outcome|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88766|NCT01848834|O1|Outcome|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88767|NCT01848834|O5|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88768|NCT01848834|O4|Outcome|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88814|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
88815|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
88769|NCT01848834|O3|Outcome|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88770|NCT01848834|O2|Outcome|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88771|NCT01848834|O1|Outcome|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88866|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88867|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88772|NCT01848834|O5|Outcome|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88773|NCT01848834|O4|Outcome|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88774|NCT01848834|O3|Outcome|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88775|NCT01848834|O2|Outcome|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88776|NCT01848834|O1|Outcome|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88777|NCT01848834|E5|Reported Event|Cohort D: Gastric Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88778|NCT01848834|E4|Reported Event|Cohort C: Urothelial Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88779|NCT01848834|E3|Reported Event|Cohort A: Triple Negative Breast Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88780|NCT01848834|E2|Reported Event|Cohort B2: Head & Neck Cancer Expansion|Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88781|NCT01848834|E1|Reported Event|Cohort B: Head & Neck Cancer|Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
88782|NCT01848756|B1|Baseline|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
88783|NCT01848756|P1|Participant Flow|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
88816|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
88817|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
88784|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
88785|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
88786|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
88787|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
88788|NCT01848756|O1|Outcome|SNX-5422|SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
88789|NCT01848756|O1|Outcome|SNX-5422|SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
88790|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
88791|NCT01848756|E1|Reported Event|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
88792|NCT01848366|B1|Baseline|Biowave Treatment|"Twelve weekly treatments
Biowave Treatment: Twelve weekly treatments"
88793|NCT01848366|P1|Participant Flow|Biowave Treatment|"Twelve weekly treatments
Biowave Treatment: Twelve weekly treatments"
88794|NCT01848366|O1|Outcome|Biowave Treatment|"Twelve weekly treatments
Biowave Treatment: Twelve weekly treatments"
88795|NCT01848366|E1|Reported Event|Biowave Treatment|"Twelve weekly treatments
Biowave Treatment: Twelve weekly treatments"
88796|NCT01848288|B1|Baseline|Overall|First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
88797|NCT01848288|P1|Participant Flow|Overall|First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
88798|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
88799|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
88800|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
88801|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
88802|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
88803|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
88804|NCT01848288|E1|Reported Event|Overall|"First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group. For non-ocular adverse events, at risk population is included with unit of subjects. For ocular adverse events, at risk population is included with unit of eyes by treatment group."
88805|NCT01848210|B3|Baseline|Total|Total of all reporting groups
88806|NCT01848210|B2|Baseline|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
88807|NCT01848210|B1|Baseline|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
88808|NCT01848210|P2|Participant Flow|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
88809|NCT01848210|P1|Participant Flow|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
88810|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
88811|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
88818|NCT01848210|E2|Reported Event|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
88819|NCT01848210|E1|Reported Event|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
88868|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88869|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88870|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88871|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88872|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88820|NCT01848145|B1|Baseline|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. The goal is to complete infusion #3 within 120 minutes (+/- 15 minutes).
Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
88821|NCT01848145|P1|Participant Flow|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. .
Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
88822|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.
Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
88823|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.
Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
88824|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.
Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
88825|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.
Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
88826|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.
Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
88857|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88827|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.
Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
88873|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88828|NCT01848145|E1|Reported Event|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. The goal infusion time at Infusion #3 is 120 minutes.
Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
88829|NCT01848054|B3|Baseline|Total|Total of all reporting groups
88830|NCT01848054|B2|Baseline|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88831|NCT01848054|B1|Baseline|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88832|NCT01848054|P2|Participant Flow|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88833|NCT01848054|P1|Participant Flow|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88834|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label)
88835|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88836|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88837|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88838|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88839|NCT01848054|O1|Outcome|BNX Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88840|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88841|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Day 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88842|NCT01848054|O2|Outcome|Buprenorphine Induction|"Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label)
OX219 buprenorphine/naloxone: OX219 buprenorphine/naloxone sublingual tablets
Buprenorphine: Buprenorphine sublingual tablets"
88843|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88844|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88845|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88846|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88847|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88848|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88849|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88850|NCT01848054|E2|Reported Event|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88851|NCT01848054|E1|Reported Event|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
88852|NCT01847547|B3|Baseline|Total|Total of all reporting groups
88853|NCT01847547|B2|Baseline|Warfarin|Propensity score matched patients starting treatment with warfarin
88854|NCT01847547|B1|Baseline|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88855|NCT01847547|P2|Participant Flow|Warfarin|Propensity score matched patients starting treatment with warfarin
88856|NCT01847547|P1|Participant Flow|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88858|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88859|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88860|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88861|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88862|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88863|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88864|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88876|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88877|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88878|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88879|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88880|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88881|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88882|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88883|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88884|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88885|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88886|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88887|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88888|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88889|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
88890|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88891|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with warfarin
88892|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88893|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with warfarin
88894|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88895|NCT01847547|E2|Reported Event|Warfarin|Propensity score matched patients starting treatment with warfarin
88896|NCT01847547|E1|Reported Event|Dabigatran|Propensity score matched patients starting treatment with dabigatran
88897|NCT01847443|B1|Baseline|Total Participants|
88898|NCT01847443|P4|Participant Flow|4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum|Participants randomly received 4mg nicotine mint gum or 2mg nicotine mint gum or 2mg ref nicotine gum or 4mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
88899|NCT01847443|P3|Participant Flow|2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum|Participants randomly received 2mg ref nicotine gum or 4mg nicotine mint gum or 4mg ref nicotine gum or 2mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
88900|NCT01847443|P2|Participant Flow|4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum|Participants randomly received 4mg ref nicotine gum or 2mg ref nicotine gum or 2mg nicotine mint gum or 4mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
88901|NCT01847443|P1|Participant Flow|2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum|Participants randomly received 2mg nicotine mint gum or 4mg reference (ref) nicotine gum or 4mg nicotine mint gum or 2mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
88902|NCT01847443|O2|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
88903|NCT01847443|O1|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
88904|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
88905|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
88906|NCT01847443|O2|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
88907|NCT01847443|O1|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
88908|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
88909|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
88910|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
88911|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
88912|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
88913|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
88914|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
88915|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
88916|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
88917|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
88918|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
88919|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
88920|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
88921|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
88922|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
88923|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
88924|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
88925|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
88926|NCT01847443|E4|Reported Event|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
88927|NCT01847443|E3|Reported Event|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
88928|NCT01847443|E2|Reported Event|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
88929|NCT01847443|E1|Reported Event|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
88930|NCT01847430|B1|Baseline|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
88931|NCT01847430|P1|Participant Flow|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
88932|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
88933|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
88934|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
88935|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
88936|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
88937|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
88938|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
88939|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
88940|NCT01847430|E1|Reported Event|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
88941|NCT01847196|B1|Baseline|Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
88942|NCT01847196|P1|Participant Flow|Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
88943|NCT01847196|O1|Outcome|Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
88944|NCT01847196|O1|Outcome|Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
88945|NCT01847196|E1|Reported Event|Angel® Catheter|"All eligible subjects received an Angel® Catheter.
The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
88946|NCT01847131|B3|Baseline|Total|Total of all reporting groups
88947|NCT01847131|B2|Baseline|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily
Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
88948|NCT01847131|B1|Baseline|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily
oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
88949|NCT01847131|P2|Participant Flow|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily
Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
88950|NCT01847131|P1|Participant Flow|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily
oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
88951|NCT01847131|O2|Outcome|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily
Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
88952|NCT01847131|O1|Outcome|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily
oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
89014|NCT01846455|B5|Baseline|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
88953|NCT01847131|O2|Outcome|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily
Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
88954|NCT01847131|O1|Outcome|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily
oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
88955|NCT01847131|E2|Reported Event|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily
Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
88956|NCT01847131|E1|Reported Event|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily
oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
88957|NCT01846741|B1|Baseline|VNS Therapy (ITT Population)|Subjects who were implanted with the AspireSR® VNS Therapy® System.
88958|NCT01846741|P1|Participant Flow|VNS Therapy - ITT Population|"Subjects who were implanted with the AspireSR® VNS Therapy® System.
The intent-to-treat (ITT) population is defined as all subjects with the VNS Therapy system implanted and the device had been turned on."
88959|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
88960|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
88961|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
88962|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
88963|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
88964|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
88965|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
88966|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
88967|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
88968|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
88969|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
88970|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
88971|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
88972|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
88973|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
88974|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
88975|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
88976|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
88977|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
88978|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
88979|NCT01846741|O4|Outcome|6-Month Visit|Users' Overall Assessment of Device Usability
88980|NCT01846741|O3|Outcome|EMU Discharge|Users' Overall Assessment of Device Usability
88981|NCT01846741|O2|Outcome|EMU Day-1|Users' Overall Assessment of Device Usability
88982|NCT01846741|O1|Outcome|Implant/Recovery|Users' Overall Assessment of Device Usability
88983|NCT01846741|O1|Outcome|Number of Subjects|Experienced Adverse Events Greater Than 5% Incidence
88984|NCT01846741|O1|Outcome|VNS Therapy|ITT Population
88985|NCT01846741|O1|Outcome|AED Load|Percent Change From Baseline by Visit
88986|NCT01846741|O2|Outcome|Overall Seizure Responder Rate|Overall Seizure (All Seizure Types)
88987|NCT01846741|O1|Outcome|Partial Onset Seizure Responder Rate|Partial Onset Seizures (SPS, CPS, CPS with Secondary GTC)
88988|NCT01846741|O4|Outcome|QOLIE-31-P Scores at 18-Months|Change From Baseline at Each Category
88989|NCT01846741|O3|Outcome|QOLIE-31-P Scores at 12-Months|Change From Baseline at Each Category
88990|NCT01846741|O2|Outcome|QOLIE-31-P Scores at 6-Months|Change From Baseline at Each Category
88991|NCT01846741|O1|Outcome|QOLIE-31-P Scores at 3-Months|Change From Baseline at Each Category
88992|NCT01846741|O4|Outcome|SSQ Scores at 18 Months|Change From Baseline at Each Category
88993|NCT01846741|O3|Outcome|SSQ Scores at 12 Months|Change From Baseline at Each Category
88994|NCT01846741|O2|Outcome|SSQ Scores at 6 Months|Change From Baseline at Each Category
88995|NCT01846741|O1|Outcome|SSQ Scores at 3 Months|Change From Baseline at Each Category
88996|NCT01846741|O3|Outcome|Simple Partial Seizure (SPS)|NHS3 Scores at Follow-Up Visits
88997|NCT01846741|O2|Outcome|CPS w/2nd GTC|NHS3 Scores at Follow-up Visits
88998|NCT01846741|O1|Outcome|Complex Partial Seizure (CPS)|NHS3 Scores at Follow-Up Visits
88999|NCT01846741|O6|Outcome|Unknown Seizures|During AutoStim Course in The EMU
89000|NCT01846741|O5|Outcome|Sub-Clinical Seizures|During AutoStim Course in The EMU
89001|NCT01846741|O4|Outcome|Simple Partial Seizures|During AutoStim Course in The EMU
89002|NCT01846741|O3|Outcome|Secondary Generalized Seizures|During AutoStim Course in The EMU
89003|NCT01846741|O2|Outcome|Complex Partial Seizures|During AutoStim Course in The EMU
89004|NCT01846741|O1|Outcome|Overall Seizures|During AutoStim Course in The EMU
89005|NCT01846741|O2|Outcome|During EMU Stay Stair-Stepper Exercise|Non-Seizure Related Stimulation Rate (AutoStim Per Hour)
89006|NCT01846741|O1|Outcome|During EMU Stay|Non-Seizure Related Stimulation Rate (AutoStim Per Hour)
89007|NCT01846741|O1|Outcome|% Sensitivity|Based on Heart rate Increase Associated with Seizures by Threshold for AutoStim
89008|NCT01846741|O1|Outcome|% Sensitivity|Based on Heart rate Increase Associated with Seizures by Threshold for AutoStim
89009|NCT01846741|O3|Outcome|Total|Seizures Reported by Investigators and Triple Reviewers
89010|NCT01846741|O2|Outcome|Reported by Triple Review|EMU Seizures Identified Post EMU
89011|NCT01846741|O1|Outcome|Reported By Investigators|All Seizures Identified (During EMU)
89012|NCT01846741|E1|Reported Event|VNS Therapy - Safety Population|All adverse events were collected from baseline up to the end of study for all subjects treated/implanted with the AspireSR® VNS Therapy® system. Only the most common AEs (> 5%) are reported in the AE data table.
89013|NCT01846455|B6|Baseline|Total|Total of all reporting groups
89494|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
89015|NCT01846455|B4|Baseline|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89016|NCT01846455|B3|Baseline|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89017|NCT01846455|B2|Baseline|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89018|NCT01846455|B1|Baseline|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89019|NCT01846455|P5|Participant Flow|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89020|NCT01846455|P4|Participant Flow|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89021|NCT01846455|P3|Participant Flow|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89022|NCT01846455|P2|Participant Flow|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89023|NCT01846455|P1|Participant Flow|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89024|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89025|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89026|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89027|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89028|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89029|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89030|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89031|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89032|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89033|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89034|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89035|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89091|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
89330|NCT01845025|B1|Baseline|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89036|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89037|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89038|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89039|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89040|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89041|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89042|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89043|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89044|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89045|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89046|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89047|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89048|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89049|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89050|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89051|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89052|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89053|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89054|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89055|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89056|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89057|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89058|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89059|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89060|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89061|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89062|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89063|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89064|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89065|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89066|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89067|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89068|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89069|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89070|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89071|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89072|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89073|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89074|NCT01846455|E5|Reported Event|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89075|NCT01846455|E4|Reported Event|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89076|NCT01846455|E3|Reported Event|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89077|NCT01846455|E2|Reported Event|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89078|NCT01846455|E1|Reported Event|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
89079|NCT01846442|B5|Baseline|Total|Total of all reporting groups
89080|NCT01846442|B4|Baseline|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
89081|NCT01846442|B3|Baseline|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
89082|NCT01846442|B2|Baseline|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
89083|NCT01846442|B1|Baseline|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
89084|NCT01846442|P4|Participant Flow|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
89085|NCT01846442|P3|Participant Flow|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
89086|NCT01846442|P2|Participant Flow|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
89087|NCT01846442|P1|Participant Flow|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
89088|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
89089|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
89090|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
89092|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
89093|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
89094|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
89095|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
89096|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
89097|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
89812|NCT01843348|P3|Participant Flow|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
89098|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
89099|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
89100|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
89101|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
89102|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
89103|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
89104|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
89105|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
89106|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
89107|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
89108|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
89109|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
89110|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
89111|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
89112|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
89113|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
89114|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
89115|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
89116|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
89117|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
89118|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
89119|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
89120|NCT01846442|E4|Reported Event|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
89121|NCT01846442|E3|Reported Event|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
89122|NCT01846442|E2|Reported Event|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
89123|NCT01846442|E1|Reported Event|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
89124|NCT01846416|B4|Baseline|Total|Total of all reporting groups
89125|NCT01846416|B3|Baseline|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89126|NCT01846416|B2|Baseline|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89127|NCT01846416|B1|Baseline|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89128|NCT01846416|P3|Participant Flow|Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89150|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89129|NCT01846416|P2|Participant Flow|Atezolizumab (MPDL3280): 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89130|NCT01846416|P1|Participant Flow|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced non-small cell lung cancer (NSCLC) disease received atezolizumab intravenously (IV) as a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until disease progression.
89131|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : All Arms|All participants included in the study were reported.
89132|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : All Arms|All participants included in the study were reported.
89133|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89134|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89135|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89136|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89137|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89138|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89139|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89140|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89141|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89142|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89143|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89144|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89145|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89146|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89147|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89148|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89149|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280): 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89151|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89152|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89153|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89154|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89155|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89156|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89157|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89158|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89159|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89160|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89161|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89162|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89163|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89164|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89165|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89166|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89167|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89168|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89169|NCT01846416|E3|Reported Event|Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89199|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89170|NCT01846416|E2|Reported Event|Atezolizumab (MPDL3280A) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
89171|NCT01846416|E1|Reported Event|Atezolizumab (MPDL3280A) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
89172|NCT01846299|B3|Baseline|Total|Total of all reporting groups
89173|NCT01846299|B2|Baseline|Sham|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89174|NCT01846299|B1|Baseline|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89495|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
89175|NCT01846299|P2|Participant Flow|Sham|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89176|NCT01846299|P1|Participant Flow|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89177|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
89178|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89179|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89180|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
89181|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89182|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89183|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
89184|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89185|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89186|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89187|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89188|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89189|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89190|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89191|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89192|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89193|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89194|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89195|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89196|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89197|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89198|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89200|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89201|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89202|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89203|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89339|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89204|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89205|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89206|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
89207|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
89208|NCT01846299|E3|Reported Event|Sham Without Ranibizumab 0.5mg|Sham without Ranibizumab 0.5mg
89209|NCT01846299|E2|Reported Event|Sham With Ranibizumab 0.5mg|Sham with Ranibizumab 0.5mg
89210|NCT01846299|E1|Reported Event|Ranibizumab 0.5mg|Ranibizumab 0.5mg
89211|NCT01846104|B1|Baseline|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
89212|NCT01846104|P1|Participant Flow|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial (NCT01317667). Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
89213|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
89214|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
89215|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
89216|NCT01846104|E1|Reported Event|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc
50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
89217|NCT01846039|B1|Baseline|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
89218|NCT01846039|P1|Participant Flow|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
89219|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
89220|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
89221|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
89222|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
89223|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
89224|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
89225|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
89226|NCT01846039|E1|Reported Event|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
89227|NCT01845831|B3|Baseline|Total|Total of all reporting groups
89228|NCT01845831|B2|Baseline|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
89229|NCT01845831|B1|Baseline|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89250|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:
Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
89822|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
89230|NCT01845831|P5|Participant Flow|Metformin and Sitagliptin + Glargine 80%|"Outpatient Phase:
Patients with HbA1c > 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months
Metformin and sitagliptin + glargine 80%: Patients with HbA1c > 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months"
89231|NCT01845831|P4|Participant Flow|Metformin and Sitagliptin + Glargine 50%|"Outpatient Phase:
Patients with HbA1c between 7% and 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months
Metformin and sitagliptin + glargine 50%: Patients with HbA1c between 7% and 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months"
89232|NCT01845831|P3|Participant Flow|Metformin and Sitagliptin|"Outpatient Phase:
Patients with HbA1c ≤ 7% during the inpatient phase were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months
Metformin and sitagliptin: Patients with HbA1c ≤ 7% were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months"
89302|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89233|NCT01845831|P2|Participant Flow|Basal Bolus (Hospital)|"Inpatient Phase:
Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
89234|NCT01845831|P1|Participant Flow|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:
Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89235|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
89236|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89237|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
89238|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89239|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
89240|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89241|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
89242|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89243|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
89244|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89245|NCT01845831|O3|Outcome|Metformin and Sitagliptin + Glargine 80%|"Outpatient Phase:
Patients with HbA1c > 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months
Metformin and sitagliptin + glargine 80%: Patients with HbA1c > 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months"
89246|NCT01845831|O2|Outcome|Metformin and Sitagliptin + Glargine 50%|"Outpatient Phase:
Patients with HbA1c between 7% and 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months
Metformin and sitagliptin + glargine 50%: Patients with HbA1c between 7% and 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months"
89247|NCT01845831|O1|Outcome|Metformin and Sitagliptin|"Outpatient Phase:
Patients with HbA1c < 7% during the inpatient phase were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months
Metformin and sitagliptin: Patients with HbA1c ≤ 7% were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months"
89248|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:
Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
89249|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:
Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89251|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:
Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89252|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:
Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
89253|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:
Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89254|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:
Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
89255|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:
Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89256|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
89257|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89258|NCT01845831|E2|Reported Event|Basal Bolus (Hospital)|"Inpatient Phase:
Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
89259|NCT01845831|E1|Reported Event|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:
Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed
Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
89260|NCT01845155|B3|Baseline|Total|Total of all reporting groups
89261|NCT01845155|B2|Baseline|Counselling|"Counselling
Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
89262|NCT01845155|B1|Baseline|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model
Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.
For more details on the music therapy see Argstatter et al. 2012"
89263|NCT01845155|P2|Participant Flow|Counselling|"Counselling
Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
89264|NCT01845155|P1|Participant Flow|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model
Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.
For more details on the music therapy see Argstatter et al. 2012"
89265|NCT01845155|O2|Outcome|Counselling|"Counselling
Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
89266|NCT01845155|O1|Outcome|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model
Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.
For more details on the music therapy see Argstatter et al. 2012"
89267|NCT01845155|O2|Outcome|Counselling|"Counselling
Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
89268|NCT01845155|O1|Outcome|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model
Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.
For more details on the music therapy see Argstatter et al. 2012"
89269|NCT01845155|E2|Reported Event|Counselling|"Counselling
Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
89295|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89296|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89270|NCT01845155|E1|Reported Event|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model
Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.
For more details on the music therapy see Argstatter et al. 2012"
89271|NCT01845103|B1|Baseline|PEARL 8.0|
89272|NCT01845103|P1|Participant Flow|PEARL 8.0|Received TMR with PEARL 8.0
89273|NCT01845103|O1|Outcome|PEARL 8.0|
89274|NCT01845103|O1|Outcome|PEARL 8.0|
89275|NCT01845103|E1|Reported Event|PEARL 8.0|
89276|NCT01845077|B4|Baseline|Total|Total of all reporting groups
89277|NCT01845077|B3|Baseline|Total 1500 Fasted|Patients were administered 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
89338|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89278|NCT01845077|B2|Baseline|Total 1000 Fed|Patients were administered 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR orally in the morning under fed conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fed conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
89279|NCT01845077|B1|Baseline|Total 1000 Fasted|Patients were administered 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
89280|NCT01845077|P6|Participant Flow|L+M1500 Fasted, Then FDC1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
89281|NCT01845077|P5|Participant Flow|FDC1500 Fasted, Then L+M1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
89282|NCT01845077|P4|Participant Flow|L+M1000 Fed, Then FDC1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
89283|NCT01845077|P3|Participant Flow|FDC1000 Fed, Then L+M1000 Fed|1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
89284|NCT01845077|P2|Participant Flow|L+M1000 Fasted, Then FDC1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
89285|NCT01845077|P1|Participant Flow|FDC1000 Fasted, Then L+M1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
89286|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89287|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89288|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89289|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89290|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89291|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89292|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
89293|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89294|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89297|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89298|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
89299|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89300|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89301|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89340|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89303|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89304|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
89305|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89306|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89307|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89308|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89309|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89310|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89311|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89312|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89313|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89314|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89315|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89316|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
89317|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89318|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89319|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89320|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89321|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89322|NCT01845077|E6|Reported Event|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
89323|NCT01845077|E5|Reported Event|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89324|NCT01845077|E4|Reported Event|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89325|NCT01845077|E3|Reported Event|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
89326|NCT01845077|E2|Reported Event|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89327|NCT01845077|E1|Reported Event|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
89328|NCT01845025|B3|Baseline|Total|Total of all reporting groups
89329|NCT01845025|B2|Baseline|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89331|NCT01845025|P2|Participant Flow|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89332|NCT01845025|P1|Participant Flow|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89333|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89334|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89335|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89336|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89337|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89341|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89342|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89343|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89344|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89345|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89346|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89347|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89348|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89349|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89350|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89351|NCT01845025|E2|Reported Event|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
89352|NCT01845025|E1|Reported Event|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
89353|NCT01844895|B1|Baseline|125 mg Abatacept (Autoinjector and Prefilled Syringe)|Participants self administered 125 mg SC abatacept weekly via prefilled syringe from Day 1 up to Day 29. Starting on Day 29, 125 mg SC abatacept was self administered weekly via autoinjector for 3 months.
89354|NCT01844895|P1|Participant Flow|125 mg Abatacept (Autoinjector and Prefilled Syringe)|125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months. Participants could discontinue from the autoinjector substudy and switch back to prefilled syringes at any time during the study. Following the 4 months of the substudy, participants could continue to receive abatacept SC via the autoinjector or switch back to the prefilled syringe until the close of the IM101-174 parent study.
89355|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector- Day 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
89356|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe - Day 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
89357|NCT01844895|O2|Outcome|125 mg Abatacept SC Using Autoinjector|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
89358|NCT01844895|O1|Outcome|125 mg Abatacept SC Using Prefilled Syringe|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
89359|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
89360|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe-Days 22, 24, 25, 26, 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
89361|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
89362|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe-Days 22, 24, 25, 26, 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
89363|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
89364|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe - Days 22, 24, 25, 26,29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
89365|NCT01844895|O2|Outcome|125 mg Abatacept SC Using Autoinjector - Day 113|125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
89366|NCT01844895|O1|Outcome|125 mg Abatacept SC Using Prefilled Syringe - Day 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
89451|NCT01844778|E4|Reported Event|COLI/TIP - Cycle 2|During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89367|NCT01844895|E2|Reported Event|Abatacept Cumulative (Prefilled Syringe and Autoinjector)|125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months.
89368|NCT01844895|E1|Reported Event|Abatacept Via Autoinjector Only (Day 29 to End of Study)|Participants received 125 mg SC abatacept via the autoinjector starting Day 29 and through the remaining 3 months of the substudy.
89369|NCT01844856|B3|Baseline|Total|Total of all reporting groups
89370|NCT01844856|B2|Baseline|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
89371|NCT01844856|B1|Baseline|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
89372|NCT01844856|P2|Participant Flow|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 grams (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days.
89373|NCT01844856|P1|Participant Flow|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered intravenously (IV) at a dose of 1.0 milligrams per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days.
89374|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
89375|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
89376|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
89377|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
89378|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
89379|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
89380|NCT01844856|E2|Reported Event|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
89381|NCT01844856|E1|Reported Event|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
89382|NCT01844830|B3|Baseline|Total|Total of all reporting groups
89383|NCT01844830|B2|Baseline|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89384|NCT01844830|B1|Baseline|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89385|NCT01844830|P2|Participant Flow|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89386|NCT01844830|P1|Participant Flow|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89387|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89388|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89389|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89390|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89391|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89392|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89393|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89394|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89395|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89396|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89433|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89397|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89398|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89399|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89400|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89401|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89402|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89403|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89404|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89405|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89406|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89407|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89408|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89409|NCT01844830|O2|Outcome|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89410|NCT01844830|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89477|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
89478|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
89411|NCT01844830|E2|Reported Event|Placebo|"Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer"
89412|NCT01844830|E1|Reported Event|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic"
89413|NCT01844817|B3|Baseline|Total|Total of all reporting groups
89414|NCT01844817|B2|Baseline|Placebo|"Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89490|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
89491|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
89415|NCT01844817|B1|Baseline|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89416|NCT01844817|P2|Participant Flow|Placebo|"Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89417|NCT01844817|P1|Participant Flow|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89418|NCT01844817|O2|Outcome|Placebo|"Placebo (Dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89419|NCT01844817|O1|Outcome|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89420|NCT01844817|O2|Outcome|Placebo|"Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89421|NCT01844817|O1|Outcome|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89422|NCT01844817|O2|Outcome|Placebo|"Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89423|NCT01844817|O1|Outcome|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89424|NCT01844817|E2|Reported Event|Placebo|"Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89425|NCT01844817|E1|Reported Event|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.
Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
89426|NCT01844778|B4|Baseline|Total|Total of all reporting groups
89427|NCT01844778|B3|Baseline|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89479|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
89428|NCT01844778|B2|Baseline|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89429|NCT01844778|B1|Baseline|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89430|NCT01844778|P3|Participant Flow|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89431|NCT01844778|P2|Participant Flow|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89432|NCT01844778|P1|Participant Flow|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89434|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89435|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89436|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89437|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89438|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89439|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89440|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89441|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89442|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89443|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89444|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89445|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89446|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89447|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89448|NCT01844778|E7|Reported Event|Overall TIP Cycle 2|During the second cycle, each treatment group received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89449|NCT01844778|E6|Reported Event|TIP/TIP - Cycle 2|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89450|NCT01844778|E5|Reported Event|TIP/TIP - Cycle 1|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89452|NCT01844778|E3|Reported Event|COLI/TIP - Cycle 1|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines.
89453|NCT01844778|E2|Reported Event|TIS/TIP - Cycle 2|During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
89454|NCT01844778|E1|Reported Event|TIS/TIP - Cycle 1|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment.
89455|NCT01844700|B3|Baseline|Total|Total of all reporting groups
89456|NCT01844700|B2|Baseline|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 patients were randomized to usual care"
89457|NCT01844700|B1|Baseline|Ziprasidone|"(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 patients were randomized to Ziprasidone"
89492|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
89493|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
89458|NCT01844700|P2|Participant Flow|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants"
89459|NCT01844700|P1|Participant Flow|Ziprasidone|"(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants"
89460|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants, only two completed study, no sufficient data for weight changes"
89461|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
89462|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants, only two completed study, no sufficient data for weight changes"
89463|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
89464|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants, only two completed study, no sufficient data for weight changes"
89465|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
89466|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants, only two completed study, no sufficient data for weight changes"
89467|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
89468|NCT01844700|E2|Reported Event|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants, only two completed study, no sufficient data for weight changes
there were no serious adverse events in this group"
89469|NCT01844700|E1|Reported Event|Ziprasidone|"(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes
there were no serious adverse events in this group"
89470|NCT01844687|B1|Baseline|Single Group|"Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol
A subset of study completers will be given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion"
89471|NCT01844687|P1|Participant Flow|Single Group|"Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol
A subset of study completers will be given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion"
89472|NCT01844687|O1|Outcome|Plasma CBD Concentrations|Eight of the 31 participants who completed the study came to a ninth session to receive 800 mg CBD and donate seven blood samples over six hours, one immediately before swallowing CBD capsules, and 6 throughout the next six hours. Plasma samples were analyzed through NIDA contract #NO1DA-14-7788 to David Moody, Ph.D.
89473|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
89474|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
89475|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
89476|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
89480|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
89481|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
89482|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
89483|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
89484|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
89485|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
89486|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
89487|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
89488|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
89489|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
89496|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
89497|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
89498|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
89499|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
89500|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
89501|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
89502|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
89503|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
89504|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|a placebo comparator measuring the effect of CBD on the strength of effects of smoking 5.30% THC cannabis cigarettes
89505|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
89506|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
89507|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
89508|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
89509|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
89510|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
89511|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
89512|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|a placebo comparator measuring the effect of CBD on liking the effects of smoking 5.30% THC cannabis cigarettes
89513|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
89514|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
89515|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
89516|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
89517|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
89518|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
89519|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
89520|NCT01844687|O1|Outcome|Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)|a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
89521|NCT01844687|E8|Reported Event|Inactive MJ With 800 mg CBD|"31 subjects were tested with 800 mg CBD and Inactive MJ cigarette.
8 of the 31 study completers were given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion. No MJ cigarette was smoked during this session. Adverse events reported during this session are included here."
89522|NCT01844687|E7|Reported Event|Inactive MJ With 400 mg CBD|31 subjects were tested with 400 mg CBD and an inactive marijuana cigarette.
89523|NCT01844687|E6|Reported Event|Inactive MJ With 200 mg CBD|31 subjects were tested with 0 mg CBD and an inactive MJ cigarette.
89524|NCT01844687|E5|Reported Event|Inactive MJ With 0 mg CBD|31 subjects were tested with 0 mg CBD and an inactive MJ cigarette.
89525|NCT01844687|E4|Reported Event|Active MJ With 800 mg CBD|31 subjects were tested with 800 mg CBD and an active MJ cigarette.
89526|NCT01844687|E3|Reported Event|Active MJ With 400 mg CBD|31 subjects were tested with 400 mg CBD and an active marijuana cigarette.
89527|NCT01844687|E2|Reported Event|Active MJ With 200 mg CBD|31 subjects were tested with 200 mg CBD and an active marijuana cigarette.
89528|NCT01844687|E1|Reported Event|Active MJ With 0 mg CBD|31 subjects were tested with 0 mg CBD and an active marijuana cigarette.
89529|NCT01844531|B5|Baseline|Total|Total of all reporting groups
89530|NCT01844531|B4|Baseline|Empa5+Met500/ FDC Empa5/ Empa12.5+Met500/ FDC Empa12.5|Participants first received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). Oral administration.
89557|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89558|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89531|NCT01844531|B3|Baseline|FDC Empa5/ Empa5+Met500/ FDC Empa12.5/ Empa12.5+Met500|Participants first received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets)Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
89532|NCT01844531|B2|Baseline|Empa12.5+Met500/ FDC Empa12.5/ Empa5+Met500/ FDC Empa5|"Participants first received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC).
Oral administration."
89533|NCT01844531|B1|Baseline|FDC Empa12.5/ Empa12.5+Met500/ FDC Empa5/ Empa5+Met500|"Participants first received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets).
Oral administration."
89656|NCT01843972|O4|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
89534|NCT01844531|P4|Participant Flow|Empa5+Met500/ FDC Empa5/ Empa12.5+Met500/ FDC Empa12.5|Participants first received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). Oral administration.
89535|NCT01844531|P3|Participant Flow|FDC Empa5/ Empa5+Met500/ FDC Empa12.5/ Empa12.5+Met500|Participants first received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets)Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
89536|NCT01844531|P2|Participant Flow|Empa12.5+Met500/ FDC Empa12.5/ Empa5+Met500/ FDC Empa5|Participants first received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). Oral administration.
89537|NCT01844531|P1|Participant Flow|FDC Empa12.5/ Empa12.5+Met500/ FDC Empa5/ Empa5+Met500|Participants first received Treatment T1 (12.5 mg empagliflozin/500 mg metformin Fixed Dose Combination (FDC)). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
89538|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89539|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89540|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89541|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89542|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89543|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89544|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89545|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89546|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89547|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89548|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89549|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89550|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89551|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89552|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89553|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89554|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89555|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89556|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89559|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89560|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89561|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89562|NCT01844531|E4|Reported Event|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89563|NCT01844531|E3|Reported Event|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89564|NCT01844531|E2|Reported Event|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
89565|NCT01844531|E1|Reported Event|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
89657|NCT01843972|O3|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
89566|NCT01844518|B1|Baseline|SC Abatacept Ages 6 to 17|Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
89567|NCT01844518|P1|Participant Flow|SC Abatacept Ages 6 to 17|Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
89568|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
89569|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
89570|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
89571|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
89572|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
89573|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
89574|NCT01844518|O3|Outcome|>=50 kg Dosing Group|Weight-tiered dosing group receiving 125 mg subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
89575|NCT01844518|O2|Outcome|25 to <50 kg Dosing Group|Weight-tiered dosing group receiving 87.5 mg subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
89576|NCT01844518|O1|Outcome|10 to <25 kg Dosing Group|Weight-tiered dosing group receiving 50 milligrams (mg) subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
89577|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
89578|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
89579|NCT01844518|E1|Reported Event|SC Abatacept Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
89580|NCT01844479|B1|Baseline|All Study Participants|"The industry standard diabetic innersole will be used as the active comparator
Standard innersole
The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load."
89581|NCT01844479|P2|Participant Flow|Diabetic Foot Orthotic Followed by Standard Innersole|"The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89582|NCT01844479|P1|Participant Flow|Standard Innersole Followed by DFO|"The industry standard diabetic innersole will be used as the active comparator
Standard innersole
DFO The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load."
89616|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89617|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89813|NCT01843348|P2|Participant Flow|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
89583|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89584|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.
The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89585|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89586|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.
The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89587|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89588|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.
The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89589|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89590|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.
The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89591|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89592|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.
The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89640|NCT01843972|B2|Baseline|BI 691751dose 1 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
89641|NCT01843972|B1|Baseline|Placebo (Part I)|"placebo solution
Placebo: placebo solution"
89642|NCT01843972|P10|Participant Flow|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)
5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
89593|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89594|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.
The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89595|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89596|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.
The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89815|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
89597|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89598|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.
The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89599|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89600|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89601|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89602|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89603|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89604|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89605|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89606|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89643|NCT01843972|P9|Participant Flow|BI 691751 Tablet (Part II)|"single dose given as 1 tablet
BI 691751: 1 tablet (10 mg)"
89644|NCT01843972|P8|Participant Flow|BI 691751 Dose 7 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
89645|NCT01843972|P7|Participant Flow|BI 691751 Dose 6 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
89607|NCT01844479|E2|Reported Event|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
89608|NCT01844479|E1|Reported Event|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator
Standard innersole"
89609|NCT01844388|B3|Baseline|Total|Total of all reporting groups
89610|NCT01844388|B2|Baseline|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89611|NCT01844388|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89612|NCT01844388|P2|Participant Flow|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89613|NCT01844388|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89614|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89615|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89618|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89619|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89620|NCT01844388|E2|Reported Event|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89621|NCT01844388|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
89622|NCT01844206|B3|Baseline|Total|Total of all reporting groups
89623|NCT01844206|B2|Baseline|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.
Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
89624|NCT01844206|B1|Baseline|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose
Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
89625|NCT01844206|P2|Participant Flow|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.
Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
89626|NCT01844206|P1|Participant Flow|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose
Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
89627|NCT01844206|O2|Outcome|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.
Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
89628|NCT01844206|O1|Outcome|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose
Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
89629|NCT01844206|E2|Reported Event|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.
Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
89630|NCT01844206|E1|Reported Event|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose
Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
89631|NCT01843972|B11|Baseline|Total|Total of all reporting groups
89632|NCT01843972|B10|Baseline|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)
5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
89633|NCT01843972|B9|Baseline|BI 691751 Tablet (Part II)|"single dose given as 1 tablet
BI 691751: 1 tablet (10 mg)"
89634|NCT01843972|B8|Baseline|BI 691751 Dose 7 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
89635|NCT01843972|B7|Baseline|BI 691751 Dose 6 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
89636|NCT01843972|B6|Baseline|BI 691751 Dose 5 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
89637|NCT01843972|B5|Baseline|BI 691751 Dose 4 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
89638|NCT01843972|B4|Baseline|BI 691751 Dose 3 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
89639|NCT01843972|B3|Baseline|BI 691751 Dose 2 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
89823|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
89646|NCT01843972|P6|Participant Flow|BI 691751 Dose 5 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
89647|NCT01843972|P5|Participant Flow|BI 691751 Dose 4 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
89648|NCT01843972|P4|Participant Flow|BI 691751 Dose 3 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
89649|NCT01843972|P3|Participant Flow|BI 691751 Dose 2 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
89650|NCT01843972|P2|Participant Flow|BI 691751 Dose 1 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
89651|NCT01843972|P1|Participant Flow|Placebo (Part I)|"placebo solution
Placebo: placebo solution"
89652|NCT01843972|O8|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
89653|NCT01843972|O7|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
89654|NCT01843972|O6|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
89655|NCT01843972|O5|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
89658|NCT01843972|O2|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
89659|NCT01843972|O1|Outcome|Placebo (Part I)|"placebo solution
Placebo: placebo solution"
89660|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)
5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
89661|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
89662|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
89663|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
89664|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
89665|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
89666|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
89667|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
89668|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)
5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
89669|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
89670|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
89671|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
89672|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
89673|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
89674|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
89675|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
89676|NCT01843972|O10|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)
5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
89677|NCT01843972|O9|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
89678|NCT01843972|O8|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
89679|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
89680|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
89681|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
89682|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
89683|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
89684|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
89685|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
89686|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)
5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
89687|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
89688|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
89824|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
89689|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
89690|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
89691|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
89692|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
89693|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
89694|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)
5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
89695|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
89696|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
89697|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
89816|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
89698|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
89699|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
89700|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
89701|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
89702|NCT01843972|O3|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)
5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
89703|NCT01843972|O2|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
89704|NCT01843972|O1|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
89705|NCT01843972|O3|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)
5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
89706|NCT01843972|O2|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|"single dose given as 1 tablet; poor metabolizers;
BI 691751: 1 tablet (10 mg)"
89707|NCT01843972|O1|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|"single dose given as 1 tablet; extensive metabolizers;
BI 691751: 1 tablet (10 mg)"
89708|NCT01843972|E10|Reported Event|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)
5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
89709|NCT01843972|E9|Reported Event|BI 691751 Tablet (Part II)|"single dose given as 1 tablet
BI 691751: 1 tablet (10 mg)"
89710|NCT01843972|E8|Reported Event|BI 691751 Dose 7 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
89711|NCT01843972|E7|Reported Event|BI 691751 Dose 6 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
89712|NCT01843972|E6|Reported Event|BI 691751 Dose 5 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
89713|NCT01843972|E5|Reported Event|BI 691751 Dose 4 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
89714|NCT01843972|E4|Reported Event|BI 691751 Dose 3 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
89715|NCT01843972|E3|Reported Event|BI 691751 Dose 2 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
89716|NCT01843972|E2|Reported Event|BI 691751 Dose 1 (Part I)|"single dose given as oral solution
BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
89717|NCT01843972|E1|Reported Event|Placebo (Part I)|"placebo solution
Placebo: placebo solution"
89718|NCT01843933|B3|Baseline|Total|Total of all reporting groups
89719|NCT01843933|B2|Baseline|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
89720|NCT01843933|B1|Baseline|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
89721|NCT01843933|P2|Participant Flow|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
89722|NCT01843933|P1|Participant Flow|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
89723|NCT01843933|O2|Outcome|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
89724|NCT01843933|O1|Outcome|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
89725|NCT01843933|E2|Reported Event|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
89726|NCT01843933|E1|Reported Event|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
89727|NCT01843920|B3|Baseline|Total|Total of all reporting groups
89746|NCT01843777|E1|Reported Event|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.
Standard-of-Care: the standard of care in audiologic practice"
89814|NCT01843348|P1|Participant Flow|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
89728|NCT01843920|B2|Baseline|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.
Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
89729|NCT01843920|B1|Baseline|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
89730|NCT01843920|P2|Participant Flow|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.
Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
89731|NCT01843920|P1|Participant Flow|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
89732|NCT01843920|O2|Outcome|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.
Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
89733|NCT01843920|O1|Outcome|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
89734|NCT01843920|E2|Reported Event|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.
Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
89735|NCT01843920|E1|Reported Event|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.
standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
89736|NCT01843777|B3|Baseline|Total|Total of all reporting groups
89737|NCT01843777|B2|Baseline|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.
Treatment: motivational interviewing"
89738|NCT01843777|B1|Baseline|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.
Standard-of-Care: the standard of care in audiologic practice"
89739|NCT01843777|P2|Participant Flow|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.
Treatment: motivational interviewing"
89825|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
89740|NCT01843777|P1|Participant Flow|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.
Standard-of-Care: the standard of care in audiologic practice"
89741|NCT01843777|O2|Outcome|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.
Treatment: motivational interviewing"
89742|NCT01843777|O1|Outcome|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.
Standard-of-Care: the standard of care in audiologic practice"
89743|NCT01843777|O2|Outcome|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.
Treatment: motivational interviewing"
89744|NCT01843777|O1|Outcome|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.
Standard-of-Care: the standard of care in audiologic practice"
89745|NCT01843777|E2|Reported Event|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.
Treatment: motivational interviewing"
89747|NCT01843673|B1|Baseline|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.
computed tomography: Undergo FBCT
cone-beam computed tomography: Undergo dual CBCT
radiography: Undergo 2-D x-ray with Varian kV OBI
radiography: Undergo 2-D x-ray with Brain Lab ExacTrac
radiography: Undergo 2-D x-ray with Varian MV OBI
electronic portal imaging: Undergo EPID imaging
image-guided adaptive radiation therapy: Undergo IGART"
89748|NCT01843673|P1|Participant Flow|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.
computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART"
89749|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
89750|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
89751|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
89752|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
89753|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
89754|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
89755|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
89756|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
89780|NCT01843465|E1|Reported Event|Cryoablation of Atrial Fibrillation|"Maneuvers for documenting the disconnection :
Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins"
89781|NCT01843374|B3|Baseline|Total|Total of all reporting groups
89782|NCT01843374|B2|Baseline|PLACEBO|Placebo.
89757|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
89758|NCT01843673|E1|Reported Event|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.
computed tomography: Undergo FBCT
cone-beam computed tomography: Undergo dual CBCT
radiography: Undergo 2-D x-ray with Varian kV OBI
radiography: Undergo 2-D x-ray with Brain Lab ExacTrac
radiography: Undergo 2-D x-ray with Varian MV OBI
electronic portal imaging: Undergo EPID imaging
image-guided adaptive radiation therapy: Undergo IGART"
89759|NCT01843660|B1|Baseline|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89760|NCT01843660|P1|Participant Flow|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89761|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89808|NCT01843348|B4|Baseline|Total|Total of all reporting groups
89762|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89763|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89764|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89765|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89766|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89767|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89768|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89769|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89770|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89771|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89772|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89773|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89774|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89775|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89776|NCT01843660|E1|Reported Event|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
89777|NCT01843465|B1|Baseline|Cryoablation of Atrial Fibrillation|Maneuvers for documenting the disconnection :
89778|NCT01843465|P1|Participant Flow|Cryoablation of Atrial Fibrillation|"All patients underwent cryoballoon ablation of atrial fibrillation using the Achieve 20mm catheter for real-time documentation of PV potentials.
According to the maneuvers for documenting the disconnection , 4 PV types were defined:
Type 1 - Achieve allowing documentation of PV disconnection in the standard position.
Type 2 - Need of backward/proximal displacement of the Achieve catheter to display PV potentials during cryoenergy application.
Type 3 - No possibility of clear documentation of PV potentials, but capture of PV with pacing Type 4 - no real-time documentation of PV disconnection"
89779|NCT01843465|O1|Outcome|Cryoablation of Atrial Fibrillation|"Maneuvers for documenting the disconnection :
Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins"
89783|NCT01843374|B1|Baseline|TREMELIMUMAB|TREMELIMUMAB 10 mg/kg
89826|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
89827|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
89828|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
89829|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
89830|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
89831|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
89832|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
89833|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
89834|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
89835|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
89836|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
89837|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
89838|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
89839|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
89840|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
89841|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
89842|NCT01843348|O5|Outcome|CycA+Certican -Tac+MPA - Difference Between Groups|
89843|NCT01843348|O4|Outcome|Tac+Certican - Tac+MPA - Difference Between Groups|
89844|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
89845|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
89846|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
89847|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
89848|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
89849|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
89850|NCT01843348|E3|Reported Event|CycA+Certican|CycA+Certican
89851|NCT01843348|E2|Reported Event|Tac+Certican|Tac+Certican
89852|NCT01843348|E1|Reported Event|Tac+MPA|Tac+MPA
89853|NCT01843192|B4|Baseline|Total|Total of all reporting groups
89854|NCT01843192|B3|Baseline|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
89855|NCT01843192|B2|Baseline|Lobectomy|Subjects undergoing VATS lobectomy
89856|NCT01843192|B1|Baseline|Wedge Resection|Subjects undergoing VATS wedge resection
89857|NCT01843192|P3|Participant Flow|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
89858|NCT01843192|P2|Participant Flow|Lobectomy|Subjects undergoing VATS lobectomy
89859|NCT01843192|P1|Participant Flow|Wedge Resection|Subjects undergoing VATS wedge resection
89860|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
89861|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
89862|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
89863|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
89864|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
89865|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
89866|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
89867|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
89868|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
89869|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
89870|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
89871|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
89872|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
89873|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
89874|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
89875|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
89876|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
89877|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
89878|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
89879|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
89880|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
89881|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
89882|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
89883|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
89884|NCT01843192|E3|Reported Event|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
89885|NCT01843192|E2|Reported Event|Lobectomy|Subjects undergoing VATS lobectomy
89886|NCT01843192|E1|Reported Event|Wedge Resection|Subjects undergoing VATS wedge resection
89887|NCT01842906|B3|Baseline|Total|Total of all reporting groups
89888|NCT01842906|B2|Baseline|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.
Control: Sham device without EPAP"
89889|NCT01842906|B1|Baseline|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.
Theravent: nasal EPAP device"
90712|NCT01837680|E1|Reported Event|Insulin NPH|Insulin neutral protamine Hagedorn
89890|NCT01842906|P2|Participant Flow|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.
Control: Sham device without EPAP"
89891|NCT01842906|P1|Participant Flow|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.
Theravent: nasal EPAP device"
89892|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.
Theravent: nasal EPAP device"
89893|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.
Control: Sham device without EPAP"
89894|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.
Theravent: nasal EPAP device"
89895|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.
Control: Sham device without EPAP"
89896|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.
Theravent: nasal EPAP device"
89897|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.
Control: Sham device without EPAP"
89898|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.
Theravent: nasal EPAP device"
89899|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.
Control: Sham device without EPAP"
89900|NCT01842906|E2|Reported Event|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.
Theravent: nasal EPAP device"
89901|NCT01842906|E1|Reported Event|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.
Control: Sham device without EPAP"
89902|NCT01842841|B1|Baseline|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89903|NCT01842841|P1|Participant Flow|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 units per kilogram (U/kg), every other week (EOW) administered as an intravenous (IV) infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89904|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89905|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89906|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89907|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89908|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89909|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89910|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89911|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89912|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89913|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89914|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89915|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89916|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89917|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89918|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89919|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89920|NCT01842841|E1|Reported Event|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
89921|NCT01842789|B3|Baseline|Total|Total of all reporting groups
89922|NCT01842789|B2|Baseline|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance
Acessa Procedure: Acessa Procedure"
89923|NCT01842789|B1|Baseline|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance
Acessa Procedure: Acessa Procedure"
89924|NCT01842789|P2|Participant Flow|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance
Acessa Procedure: Acessa Procedure"
89925|NCT01842789|P1|Participant Flow|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance
Acessa Procedure: Acessa Procedure"
89926|NCT01842789|O2|Outcome|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance
Acessa Procedure: Acessa Procedure"
89927|NCT01842789|O1|Outcome|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance
Acessa Procedure: Acessa Procedure"
89928|NCT01842789|O2|Outcome|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance
Acessa Procedure: Acessa Procedure"
89929|NCT01842789|O1|Outcome|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance
Acessa Procedure: Acessa Procedure"
89930|NCT01842789|O1|Outcome|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance
Acessa Procedure: Acessa Procedure"
89931|NCT01842789|E2|Reported Event|Acessa Procedure With TAG|"Acessa Procedure with Targeting Animation Guidance
Acessa Procedure: Acessa Procedure"
89932|NCT01842789|E1|Reported Event|Acessa Procedure w/o TAG|"Acessa Procedure without the use of Targeting Animation Guidance
Acessa Procedure: Acessa Procedure"
89933|NCT01842646|B1|Baseline|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
89934|NCT01842646|P1|Participant Flow|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
89935|NCT01842646|O1|Outcome|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
89936|NCT01842646|O1|Outcome|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
89937|NCT01842646|O1|Outcome|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
89938|NCT01842646|E1|Reported Event|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
89939|NCT01842633|B4|Baseline|Total|Total of all reporting groups
89940|NCT01842633|B3|Baseline|Placebo Caplets|Participants were administered with four placebo caplets orally with 8 ounces of water
89941|NCT01842633|B2|Baseline|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water
89942|NCT01842633|B1|Baseline|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounces of water
89943|NCT01842633|P3|Participant Flow|Placebo Caplets|Participants were administered with four placebo caplets with 8 ounces of water
89944|NCT01842633|P2|Participant Flow|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water
89945|NCT01842633|P1|Participant Flow|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65milligram (mg) plus 2 placebo caplets orally with 8 ounces of water
89946|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89947|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89948|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89949|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89950|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89951|NCT01842633|O1|Outcome|Paracetamol/Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89952|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89953|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89954|NCT01842633|O1|Outcome|Paracetamol/ Caffiene Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89955|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89956|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89957|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89958|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89959|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89960|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89961|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89962|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89963|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89964|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89965|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89966|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89967|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89968|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89969|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89970|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89971|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89972|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89973|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89974|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89975|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89976|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89977|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89978|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89979|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89980|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89981|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89982|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89983|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89984|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89985|NCT01842633|O3|Outcome|Placebo Caplets|Participants were administered with four placebo caplets orally with eight ounce of water
89986|NCT01842633|O2|Outcome|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water
89987|NCT01842633|O1|Outcome|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water
89988|NCT01842633|E3|Reported Event|Placebo Caplets|Participants were administered with four placebo caplets orally with 8 ounce of water
89989|NCT01842633|E2|Reported Event|Ibuprofen Caplets|Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounce of water
89990|NCT01842633|E1|Reported Event|Paracetamol/ Caffeine Caplets|Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounce of water
89991|NCT01842607|B1|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
89992|NCT01842607|P1|Participant Flow|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
89993|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
89994|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
89995|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90026|NCT01842438|O2|Outcome|Control|This group will not receive the intervention during the life-span of the project
90713|NCT01837550|B3|Baseline|Total|Total of all reporting groups
89996|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
89997|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
89998|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
89999|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90000|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90001|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90002|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90003|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90004|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90005|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90006|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90007|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90008|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90009|NCT01842607|E1|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
90010|NCT01842594|B1|Baseline|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
90011|NCT01842594|P1|Participant Flow|Sirolimus and Hydroxychloroquine|Patients received 1 mg of sirolimus (rapamycin, Rapa) and 200 mg of hydroxychloroquine (HCQ) twice a day before a meal for 2 weeks.
90012|NCT01842594|O1|Outcome|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
90013|NCT01842594|O1|Outcome|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
90014|NCT01842594|E1|Reported Event|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
90015|NCT01842464|B1|Baseline|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
90016|NCT01842464|P1|Participant Flow|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
90017|NCT01842464|O1|Outcome|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
90018|NCT01842464|O1|Outcome|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
90019|NCT01842464|O1|Outcome|Anterior Sacro-Spinous Support|Number of participants with successful Sacro-Spinous Ligaments Anterior Apical Anchoring
90020|NCT01842464|E1|Reported Event|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
90021|NCT01842438|B3|Baseline|Total|Total of all reporting groups
90022|NCT01842438|B2|Baseline|Control|This group will not receive the intervention during the life-span of the project
90023|NCT01842438|B1|Baseline|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning
Behavioral: psychosexual intervention"
90024|NCT01842438|P2|Participant Flow|Control|This group will not receive the intervention during the life-span of the project
90025|NCT01842438|P1|Participant Flow|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning
Behavioral: psychosexual intervention"
90027|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning
Behavioral: psychosexual intervention"
90028|NCT01842438|O4|Outcome|Control: Partners|Did not receive the intervention; mostly females, but one male as there was one same-sex couple participating.
90029|NCT01842438|O3|Outcome|Control: Patient Group|Did not receive the intervention. All males
90030|NCT01842438|O2|Outcome|Intervention: Partners|This group received the intervention during the life-span of the project. Partners only.
90031|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention PATIENTS|"6-sessions of couple support focused on relationships and psychosexual functioning
Behavioral: psychosexual intervention
This data is patients-only (all males)"
90032|NCT01842438|O2|Outcome|Control|This group will not receive the intervention during the life-span of the project
90033|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning
Behavioral: psychosexual intervention"
90034|NCT01842438|E2|Reported Event|Control|This group will not receive the intervention during the life-span of the project
90035|NCT01842438|E1|Reported Event|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning
Behavioral: psychosexual intervention"
90036|NCT01841970|B1|Baseline|HET Arm|"Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids
HET Bipolar System: The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply."
90037|NCT01841970|P1|Participant Flow|HET Arm|All subjects enrolled into the study were treated with the HET Bipolar System
90038|NCT01841970|O3|Outcome|Month 6|
90039|NCT01841970|O2|Outcome|Month 3|
90040|NCT01841970|O1|Outcome|Month 1|
90041|NCT01841970|O3|Outcome|Month 6|
90042|NCT01841970|O2|Outcome|Month 3|
90043|NCT01841970|O1|Outcome|Month 1|
90044|NCT01841970|O3|Outcome|Month 6|
90045|NCT01841970|O2|Outcome|Month 3|
90046|NCT01841970|O1|Outcome|Month 1|
90047|NCT01841970|O3|Outcome|Month 6|
90048|NCT01841970|O2|Outcome|Month 3|
90049|NCT01841970|O1|Outcome|Month 1|
90050|NCT01841970|O1|Outcome|HET Arm|
90051|NCT01841970|E1|Reported Event|HET Arm|
90052|NCT01841697|B3|Baseline|Total|Total of all reporting groups
90053|NCT01841697|B2|Baseline|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90054|NCT01841697|B1|Baseline|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90055|NCT01841697|P2|Participant Flow|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90056|NCT01841697|P1|Participant Flow|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90057|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90058|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90059|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90060|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90061|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90108|NCT01841216|O2|Outcome|Healthy|"Lower Body Exercises with and without resistance
Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
90062|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90063|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90279|NCT01839318|B1|Baseline|Overall|Nelfilcon A contact lenses, etafilcon A contact lenses, and omafilcon A contact lenses worn in a cross-over assignment.
90064|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90065|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90066|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90067|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90068|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90069|NCT01841697|E2|Reported Event|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90070|NCT01841697|E1|Reported Event|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
90071|NCT01841619|B1|Baseline|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.
IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
90072|NCT01841619|P1|Participant Flow|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.
IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
90073|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.
IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
90074|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.
IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
90075|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.
IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
90076|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.
IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
90077|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.
IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
90078|NCT01841619|E1|Reported Event|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.
IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
90079|NCT01841593|B3|Baseline|Total|Total of all reporting groups
90080|NCT01841593|B2|Baseline|Group B|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
90081|NCT01841593|B1|Baseline|Group A|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
90082|NCT01841593|P2|Participant Flow|Group B (Amlodipine Then Raltegravir)|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
90083|NCT01841593|P1|Participant Flow|Group A (Raltegravir Then Amlodipine)|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
90084|NCT01841593|O2|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90085|NCT01841593|O1|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90086|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90087|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90088|NCT01841593|O2|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90089|NCT01841593|O1|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90090|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90091|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90092|NCT01841593|O4|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90093|NCT01841593|O3|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90094|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90095|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
90096|NCT01841593|E2|Reported Event|Group B|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
90097|NCT01841593|E1|Reported Event|Group A|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
90098|NCT01841567|B1|Baseline|Dressing|"Mepilex border post. op
Mepilex border post op"
90099|NCT01841567|P1|Participant Flow|Dressing|"Mepilex border post. op
Mepilex border post op"
90100|NCT01841567|O1|Outcome|Dressing|"Mepilex border post. op
Mepilex border post op"
90101|NCT01841567|O1|Outcome|Dressing|"Mepilex border post. op
Mepilex border post op"
90102|NCT01841567|E1|Reported Event|Dressing|"Mepilex border post. op
Mepilex border post op"
90103|NCT01841216|B3|Baseline|Total|Total of all reporting groups
90104|NCT01841216|B2|Baseline|Healthy|"Lower Body Exercises with and without resistance
Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
90105|NCT01841216|B1|Baseline|Low Back Pain|"Lower Body Exercises with and without resistance
Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
90106|NCT01841216|P2|Participant Flow|Healthy|"Lower Body Exercises with and without resistance
Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
90107|NCT01841216|P1|Participant Flow|Low Back Pain|"Lower Body Exercises with and without resistance
Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
90109|NCT01841216|O1|Outcome|Low Back Pain|"Lower Body Exercises with and without resistance
Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
90110|NCT01841216|O2|Outcome|Healthy|"Lower Body Exercises with and without resistance
Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
90111|NCT01841216|O1|Outcome|Low Back Pain|"Lower Body Exercises with and without resistance
Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
90112|NCT01841216|E2|Reported Event|Healthy|"Lower Body Exercises with and without resistance
Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
90113|NCT01841216|E1|Reported Event|Low Back Pain|"Lower Body Exercises with and without resistance
Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
90114|NCT01841021|B1|Baseline|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
90115|NCT01841021|P1|Participant Flow|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
90116|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
90117|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
90118|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
90119|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
90120|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
90121|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
90122|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
90123|NCT01841021|E1|Reported Event|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
90124|NCT01840943|B3|Baseline|Total|Total of all reporting groups
90125|NCT01840943|B2|Baseline|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90126|NCT01840943|B1|Baseline|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90127|NCT01840943|P2|Participant Flow|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90128|NCT01840943|P1|Participant Flow|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90129|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90130|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90131|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90132|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90133|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90134|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90135|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90136|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90137|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90138|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90139|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90140|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90141|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90142|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90143|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90277|NCT01839604|E2|Reported Event|1.5 mg/kg|given intravenously. Part A
90144|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90145|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90146|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90849|NCT01836458|P2|Participant Flow|Dose 2: 20 mg|Single dose of KAE609 20 mg
90147|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90148|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90149|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90150|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90151|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90152|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90153|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90154|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90155|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90156|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90157|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90158|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90159|NCT01840943|E2|Reported Event|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
90160|NCT01840943|E1|Reported Event|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
90161|NCT01840605|B3|Baseline|Total|Total of all reporting groups
90162|NCT01840605|B2|Baseline|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
90163|NCT01840605|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 2 weeks
90164|NCT01840605|P2|Participant Flow|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
90165|NCT01840605|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 2 weeks
90166|NCT01840605|O2|Outcome|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
90167|NCT01840605|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
90168|NCT01840605|E2|Reported Event|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
90169|NCT01840605|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 2 weeks
90170|NCT01840410|B3|Baseline|Total|Total of all reporting groups
90171|NCT01840410|B2|Baseline|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90172|NCT01840410|B1|Baseline|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90173|NCT01840410|P2|Participant Flow|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90174|NCT01840410|P1|Participant Flow|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90175|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
90176|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90177|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90178|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
90179|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90180|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90181|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
90182|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90183|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90184|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90850|NCT01836458|P1|Participant Flow|Dose 1: 30 mg|Single dose of KAE609 30 mg
90185|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90186|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90187|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90188|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90189|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90190|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90191|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90192|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90193|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90194|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90195|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90196|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90197|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90198|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90199|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90200|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90201|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90202|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90203|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90204|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
90205|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90206|NCT01840410|E3|Reported Event|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
90207|NCT01840410|E2|Reported Event|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.
90208|NCT01840410|E1|Reported Event|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
90209|NCT01840319|B1|Baseline|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
90210|NCT01840319|P1|Participant Flow|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
90211|NCT01840319|O1|Outcome|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
90212|NCT01840319|E1|Reported Event|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
90213|NCT01840072|B3|Baseline|Total|Total of all reporting groups
90214|NCT01840072|B2|Baseline|Usual Care|Discontinue all home BP medications.
90851|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
90215|NCT01840072|B1|Baseline|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90216|NCT01840072|P2|Participant Flow|Usual Care|Discontinue all home BP medications.
90217|NCT01840072|P1|Participant Flow|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90218|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90219|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
90220|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90221|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
90222|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90223|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
90224|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90225|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
90226|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90227|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
90228|NCT01840072|O2|Outcome|Usual Care|Discontinue all home BP medications.
90229|NCT01840072|O1|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90230|NCT01840072|O2|Outcome|Usual Care|Discontinue all home BP medications.
90278|NCT01839604|E1|Reported Event|AZD9150 1mg/kg|Intravenous. Part A.
90280|NCT01839318|P6|Participant Flow|Sequence 6|Etafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
90281|NCT01839318|P5|Participant Flow|Sequence 5|Etafilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
90231|NCT01840072|O1|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90232|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90233|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
90234|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90235|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
90236|NCT01840072|E2|Reported Event|Usual Care|Discontinue all home BP medications.
90237|NCT01840072|E1|Reported Event|Active Antihypertensive Treatment|"Active antihypertensive treatment
Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
90238|NCT01839695|B1|Baseline|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >
> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
90239|NCT01839695|P1|Participant Flow|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >
> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
90240|NCT01839695|O1|Outcome|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >
> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
90241|NCT01839695|O1|Outcome|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >
> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
90242|NCT01839695|E1|Reported Event|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >
> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
90243|NCT01839604|B6|Baseline|Total|Total of all reporting groups
90244|NCT01839604|B5|Baseline|3 mg/kg|given intravenously (Part A & B pooled)
90245|NCT01839604|B4|Baseline|2.5 mg/kg|given intravenously Part A
90246|NCT01839604|B3|Baseline|2 mg/kg|given intravenously Part A
90247|NCT01839604|B2|Baseline|1.5 mg/kg|given intravenously. Part A
90248|NCT01839604|B1|Baseline|AZD9150 1mg/kg|Intravenous. Part A.
90249|NCT01839604|P5|Participant Flow|AZD9150 3mg/kg|Pooled over parts A & B
90250|NCT01839604|P4|Participant Flow|AZD9150 2.5mg/kg|Intravenous dosing Part A
90251|NCT01839604|P3|Participant Flow|AZD9150 2mg/kg|Intravenous dosing Part A
90252|NCT01839604|P2|Participant Flow|AZD9150 1.5 mg/kg|Intravenous dosing Part A
90253|NCT01839604|P1|Participant Flow|AZD9150 1mg/kg|Intravenous. Part A.
90254|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
90255|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
90256|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
90257|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
90258|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
90259|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
90260|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
90261|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
90262|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
90263|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
90264|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
90265|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
90266|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
90267|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
90268|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
90269|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
90270|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
90271|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
90272|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
90273|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
90274|NCT01839604|E5|Reported Event|3 mg/kg|given intravenously (Part A & B pooled)
90275|NCT01839604|E4|Reported Event|2.5 mg/kg|given intravenously Part A
90276|NCT01839604|E3|Reported Event|2 mg/kg|given intravenously Part A
90282|NCT01839318|P4|Participant Flow|Sequence 4|Nelfilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
90283|NCT01839318|P3|Participant Flow|Sequence 3|Nelfilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
90284|NCT01839318|P2|Participant Flow|Sequence 2|Omafilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
90285|NCT01839318|P1|Participant Flow|Sequence 1|Omafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
90286|NCT01839318|O3|Outcome|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
90287|NCT01839318|O2|Outcome|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
90288|NCT01839318|O1|Outcome|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
90289|NCT01839318|O3|Outcome|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
90290|NCT01839318|O2|Outcome|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
90291|NCT01839318|O1|Outcome|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
90292|NCT01839318|E3|Reported Event|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
90293|NCT01839318|E2|Reported Event|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
90294|NCT01839318|E1|Reported Event|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
90295|NCT01839279|B4|Baseline|Total|Total of all reporting groups
90296|NCT01839279|B3|Baseline|Initial Moxifloxacin and Crossover to Placebo|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
90297|NCT01839279|B2|Baseline|Initial Placebo and Crossover to Moxifloxacin|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
90298|NCT01839279|B1|Baseline|Tizanidine|
90299|NCT01839279|P3|Participant Flow|Initial Moxifloxacin and Crossover to Placebo|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
90300|NCT01839279|P2|Participant Flow|Initial Placebo and Crossover to Moxifloxacin|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
90301|NCT01839279|P1|Participant Flow|Tizanidine|
90302|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
90303|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
90304|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
90305|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
90306|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
90307|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
90308|NCT01839279|O1|Outcome|Tizanidine|
90309|NCT01839279|O3|Outcome|Tizanidine 8 mg Placebo-corrected|70 subjects Tizanidine 8 mg single dose, 63 subjects placebo used for analysis.
90310|NCT01839279|O2|Outcome|Tizanidine Placebo 8 mg|63 subjects placebo used for analysis.
90311|NCT01839279|O1|Outcome|Tizanidine 8 mg|70 subjects Tizanidine 8 mg single dose.
90312|NCT01839279|O3|Outcome|Tizanidine 24 mg Placebo-corrected|60 subjects Tizanidine 24 mg single dose, 61 subjects placebo used for the analysis.
90313|NCT01839279|O2|Outcome|Tizanidine Placebo 24 mg|61 subjects placebo used for the analysis.
90314|NCT01839279|O1|Outcome|Tizanidine 24 mg|60 subjects Tizanidine 24 mg single dose
90315|NCT01839279|E4|Reported Event|Placebo and Moxifloxacin Groups Combined|
90316|NCT01839279|E3|Reported Event|Initial Moxifloxacin and Crossover to Placebo|
90317|NCT01839279|E2|Reported Event|Initial Placebo and Crossover to Moxifloxacin|
90318|NCT01839279|E1|Reported Event|Tizanidine|
90319|NCT01839058|B3|Baseline|Total|Total of all reporting groups
90320|NCT01839058|B2|Baseline|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.
Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
90321|NCT01839058|B1|Baseline|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.
Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
90322|NCT01839058|P2|Participant Flow|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.
Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
90350|NCT01838681|P4|Participant Flow|Period A+ Placebo and ADT (Non-randomised Patients)|"Placebo adjunct to open-label treatment with ADT (same ADT as in Period A)
Placebo: Once daily, tablets, orally"
90351|NCT01838681|P3|Participant Flow|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with ADT (same ADT as in Period A)
Brexpiprazole: flexible dose; 1, 2, or 3 mg/day, once daily, tablets, orally"
90323|NCT01839058|P1|Participant Flow|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.
Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
90852|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
90324|NCT01839058|O2|Outcome|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.
Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
90325|NCT01839058|O1|Outcome|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.
Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
90326|NCT01839058|E2|Reported Event|Healthy Controls|"Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.
Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
90327|NCT01839058|E1|Reported Event|Non Cardiac Chest Pain Patients|"Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.
Esophageal Manometry: Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus."
90328|NCT01838980|B1|Baseline|Colonoscopy|Motus GI Clean-Up Device
90329|NCT01838980|P1|Participant Flow|Colonoscopy|Motus GI Clean-Up Device
90330|NCT01838980|O1|Outcome|Colonoscopy|Motus GI Clean-Up Device
90331|NCT01838980|E1|Reported Event|Colonoscopy|Motus GI Clean-Up Device
90332|NCT01838941|B1|Baseline|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.
Betaine: Betaine given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube:
6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)
12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
90333|NCT01838941|P1|Participant Flow|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.
Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:
6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)
12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
90334|NCT01838941|O1|Outcome|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.
Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:
6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)
12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
90335|NCT01838941|O1|Outcome|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.
Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:
6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)
12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
90336|NCT01838941|E1|Reported Event|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.
Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:
6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)
12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
90337|NCT01838694|B3|Baseline|Total|Total of all reporting groups
90338|NCT01838694|B2|Baseline|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.
Ala-Cpn10"
90339|NCT01838694|B1|Baseline|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.
Placebo"
90340|NCT01838694|P2|Participant Flow|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.
Ala-Cpn10"
90341|NCT01838694|P1|Participant Flow|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.
Placebo"
90342|NCT01838694|O5|Outcome|Ala-Cpn10 - 30mgs in Moderate SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.
Ala-Cpn10"
90343|NCT01838694|O4|Outcome|Ala-Cpn10 - 100mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 100mg twice weekly administered intravenously by infusion over 60 minutes.
Ala-Cpn10"
90344|NCT01838694|O3|Outcome|Ala-Cpn10 - 30mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.
Ala-Cpn10"
90345|NCT01838694|O2|Outcome|Ala-Cpn10 - 10mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 10mg twice weekly administered intravenously by infusion over 60 minutes.
Ala-Cpn10"
90346|NCT01838694|O1|Outcome|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.
Placebo"
90347|NCT01838694|E2|Reported Event|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range (0.16mg/kg [10mg twice weekly] to 5mg/kg [300mg twice weekly]) administered intravenously by infusion over 60 minutes.
Ala-Cpn10"
90348|NCT01838694|E1|Reported Event|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.
Placebo"
90349|NCT01838681|B1|Baseline|All Enrolled Patients|Period A
90482|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
90352|NCT01838681|P2|Participant Flow|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with ADT (same ADT as in Period A)
Placebo: Once daily, tablets, orally"
90353|NCT01838681|P1|Participant Flow|Period A Placebo and ADT (8 Weeks)|"Placebo adjunct to open-label treatment with ADT
Placebo: Once daily, tablets, orally"
90853|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
90354|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90355|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90356|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90357|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90358|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90359|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90360|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90361|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90362|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90363|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90364|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90365|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90366|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90367|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90368|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90369|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90370|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90371|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90372|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90373|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90374|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90375|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90376|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90377|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90378|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90379|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90380|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90381|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90382|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90383|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90702|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90384|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90489|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
90385|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90386|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90387|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90388|NCT01838681|O2|Outcome|Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
90389|NCT01838681|O1|Outcome|Period B Placebo and ADT (24 Weeks Randomised Treatment)|"Placebo adjunct to open-label treatment with a commercially available ADT
Placebo: Once daily, tablets, orally"
90390|NCT01838681|E2|Reported Event|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1, 2, 3, mg/day, once daily, tablets, orally"
90391|NCT01838681|E1|Reported Event|Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90392|NCT01838642|B1|Baseline|RET Mutation Positive Participants|"Rearranged during transfection (RET)
Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
90393|NCT01838642|P1|Participant Flow|RET Mutation Positive Participants.|"Rearranged during transfection (RET)
Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
90394|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)
Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
90395|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)
Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
90396|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)
Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
90397|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)
Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
90398|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)
Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
90399|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)
Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
90400|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection (RET)
Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
90401|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)
Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
90402|NCT01838642|E1|Reported Event|RET Mutation Positive Participants|"Rearranged during transfection) (RET)
Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
90403|NCT01838616|B3|Baseline|Total|Total of all reporting groups
90404|NCT01838616|B2|Baseline|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90405|NCT01838616|B1|Baseline|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90483|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
90484|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
90490|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
90854|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
90406|NCT01838616|P2|Participant Flow|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90407|NCT01838616|P1|Participant Flow|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90408|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90409|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90410|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90411|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90412|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90413|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90414|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90415|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90416|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90417|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90418|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90419|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90485|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
90703|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90420|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90421|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90422|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90423|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90424|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90425|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90426|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90427|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90428|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90429|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90430|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90431|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90432|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90433|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90486|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
90704|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90434|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90435|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90436|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90437|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90438|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90439|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90440|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90441|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90442|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90443|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90444|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90445|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90446|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90447|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90487|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
90705|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90448|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90449|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90450|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90451|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90452|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90453|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90454|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90455|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90456|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90457|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90458|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90459|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90460|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90461|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90488|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
90706|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90462|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90463|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90464|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90465|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90466|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90467|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90468|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90469|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks
90470|NCT01838616|E3|Reported Event|Tapentadol (PR) After Oxycodone/Naloxone (PR) Treatment|Participants in the oxycodone/naloxone PR treatment arm that did not reach the minimum target of titration or experiencing intolerable side effects at the end of the Titration Period could be switched to the Pick-up Arm. They could also enter the Pick-up Arm at any time during the Titration Period or Continuation Period, via an unscheduled visit, due to lack of tolerability or lack of efficacy under treatment with oxycodone/naloxone PR. Participants were directly switched from oxycodone/naloxone PR to tapentadol PR using an equianalgesic ratio of 1:5 (oxycodone : tapentadol), together with a down-titration step under tapentadol PR (except for participants on oxycodone/naloxone PR 10 mg/5 mg twice daily).
90471|NCT01838616|E2|Reported Event|Oxycodone/Naloxone Prolonged Release (PR)|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90472|NCT01838616|E1|Reported Event|Tapentadol Prolonged Release (PR)|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
90473|NCT01838590|B5|Baseline|Total|Total of all reporting groups
90474|NCT01838590|B4|Baseline|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
90475|NCT01838590|B3|Baseline|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
90476|NCT01838590|B2|Baseline|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE))
90477|NCT01838590|B1|Baseline|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN))
90478|NCT01838590|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
90479|NCT01838590|P1|Participant Flow|SOF+RBV 12 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
90480|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
90481|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
90491|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
90492|NCT01838590|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
90493|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
90494|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
90495|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
90496|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
90497|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
90498|NCT01838590|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
90499|NCT01838590|E1|Reported Event|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
90500|NCT01838499|B3|Baseline|Total|Total of all reporting groups
90501|NCT01838499|B2|Baseline|Saline|SC injection
90502|NCT01838499|B1|Baseline|MEDI8968|SC injection
90503|NCT01838499|P2|Participant Flow|Saline|SC injection
90504|NCT01838499|P1|Participant Flow|MEDI8968|SC injection
90505|NCT01838499|O2|Outcome|Saline|SC injection
90506|NCT01838499|O1|Outcome|MEDI8968|SC injection
90507|NCT01838499|O2|Outcome|Saline|SC injection
90508|NCT01838499|O1|Outcome|MEDI8968|SC injection
90509|NCT01838499|O2|Outcome|Saline|SC injection
90510|NCT01838499|O1|Outcome|MEDI8968|SC injection
90511|NCT01838499|E2|Reported Event|Saline|SC injection
90512|NCT01838499|E1|Reported Event|MEDI8968|SC injection
90513|NCT01838213|B3|Baseline|Total|Total of all reporting groups
90514|NCT01838213|B2|Baseline|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
90515|NCT01838213|B1|Baseline|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
90516|NCT01838213|P2|Participant Flow|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
90517|NCT01838213|P1|Participant Flow|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
90518|NCT01838213|O2|Outcome|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
90519|NCT01838213|O1|Outcome|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
90520|NCT01838213|E2|Reported Event|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
90521|NCT01838213|E1|Reported Event|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
90522|NCT01838044|B3|Baseline|Total|Total of all reporting groups
90523|NCT01838044|B2|Baseline|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90524|NCT01838044|B1|Baseline|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90525|NCT01838044|P2|Participant Flow|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90526|NCT01838044|P1|Participant Flow|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90594|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90855|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
90527|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90528|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90529|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90530|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90531|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90532|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90533|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90534|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90535|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90587|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally"
90588|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90707|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90536|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90537|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90538|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90539|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90540|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90541|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90542|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90543|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90544|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90589|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally"
90590|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally"
90591|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90545|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90546|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90547|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90548|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90549|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90550|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90551|NCT01838044|O1|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90552|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90553|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90592|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally"
90593|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally"
90708|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90554|NCT01838044|E2|Reported Event|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90555|NCT01838044|E1|Reported Event|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
90556|NCT01837966|B3|Baseline|Total|Total of all reporting groups
90557|NCT01837966|B2|Baseline|Placebo|"Placebo - unscented oil aromatherapy
Placebo: 2 drops unscented mineral oil for aromatherapy"
90558|NCT01837966|B1|Baseline|Lavender Oil|"Lavender oil aromatherapy
Lavender oil: 2 drops for aromatherapy"
90559|NCT01837966|P2|Participant Flow|Placebo|"Placebo -- unscented oil aromatherapy
Placebo: 2 drops unscented mineral oil for aromatherapy"
90560|NCT01837966|P1|Participant Flow|Lavender Oil|"Lavender oil aromatherapy
Lavender oil: 2 drops for aromatherapy"
90561|NCT01837966|O2|Outcome|Placebo|"Placebo -- unscented oil aromatherapy
Placebo: 2 drops unscented mineral oil for aromatherapy
There were no adverse events for this arm."
90562|NCT01837966|O1|Outcome|Lavender Oil|"Lavender oil aromatherapy
Lavender oil: 2 drops for aromatherapy
There were no adverse events for this arm."
90563|NCT01837966|E2|Reported Event|Placebo|"Placebo -- unscented oil aromatherapy
Placebo: 2 drops unscented mineral oil for aromatherapy
There were no adverse events for this arm."
90564|NCT01837966|E1|Reported Event|Lavender Oil|"Lavender oil aromatherapy
Lavender oil: 2 drops for aromatherapy
There were no adverse events for this arm."
90565|NCT01837797|B4|Baseline|Total|Total of all reporting groups
90566|NCT01837797|B3|Baseline|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 3 mg once daily, tablets, orally"
90567|NCT01837797|B2|Baseline|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1 mg once daily, tablets, orally"
90568|NCT01837797|B1|Baseline|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90569|NCT01837797|P5|Participant Flow|Period 3 Placebo and ADT|"Placebo adjunct to open-label treatment with commercially available antidepressant treatment (ADT)
Placebo: Once daily, tablets, orally"
90570|NCT01837797|P4|Participant Flow|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally"
90571|NCT01837797|P3|Participant Flow|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally"
90572|NCT01837797|P2|Participant Flow|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90573|NCT01837797|P1|Participant Flow|Period 1 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90574|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally"
90575|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally"
90576|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90577|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally"
90578|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally"
90579|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90580|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally"
90581|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally"
90582|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90583|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally"
90584|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally"
90585|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90586|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally"
90701|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90595|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally"
90596|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally"
90597|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90598|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally"
90599|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally"
90600|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90601|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally"
90602|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally"
90603|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90604|NCT01837797|E3|Reported Event|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 3 mg once daily, tablets, orally"
90605|NCT01837797|E2|Reported Event|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1 mg once daily, tablets, orally"
90606|NCT01837797|E1|Reported Event|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally"
90607|NCT01837719|B1|Baseline|All Participants Who Received Treatment|All participants who received atazanavir with cobicistat in 1 of 8 treatment sequences (ABCDE, ABDCE, BACDE, BADCE, ABCD, ABDC, BACD, or BADC). Treatment A: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8. Treatment B: Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8. Treatment C: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22. Treatment D: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 29. Treatment E: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
90608|NCT01837719|P1|Participant Flow|All Participants Who Received Treatment|All participants who received atazanavir with cobicistat in 1 of 8 treatment sequences (ABCDE, ABDCE, BACDE, BADCE, ABCD, ABDC, BACD, or BADC). Treatment A: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat, 150 mg as tablet, following a light meal on Day 1 or 8. Treatment B: Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8. Treatment C: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day15 or 22. Treatment D: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22. Treatment E: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
90609|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
90610|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
90611|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90612|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90613|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90614|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
90615|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 22
90616|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90617|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90618|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90619|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
90620|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
90621|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90622|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90623|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90624|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
90625|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or22
90626|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90627|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90628|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90629|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
90630|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
90631|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90632|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90633|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90634|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
90635|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
90636|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90637|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90638|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90639|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
90640|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 22
90641|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90642|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90643|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90644|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
90645|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
90646|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90647|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90648|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90649|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
90650|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
90651|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90652|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90653|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90654|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
90655|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
90710|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90711|NCT01837680|E2|Reported Event|Levemir|Insulin detemir (IDet)
90656|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90657|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90658|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90659|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
90660|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
90661|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90662|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90663|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90664|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
90665|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
90666|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
90667|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
90668|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
90669|NCT01837719|E5|Reported Event|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
90670|NCT01837719|E4|Reported Event|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22.
90671|NCT01837719|E3|Reported Event|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22.
90672|NCT01837719|E2|Reported Event|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8.
90673|NCT01837719|E1|Reported Event|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat, 150 mg as tablet, following a light meal on Day 1 or 8.
90674|NCT01837680|B3|Baseline|Total|Total of all reporting groups
90675|NCT01837680|B2|Baseline|Levemir|Insulin detemir (IDet)
90676|NCT01837680|B1|Baseline|Insulin NPH|Insulin neutral protamine Hagedorn
90677|NCT01837680|P2|Participant Flow|Levemir|Insulin detemir (IDet) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.
90678|NCT01837680|P1|Participant Flow|Insulin NPH|Insulin neutral protamine Hagedorn (NPH) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.
90679|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90680|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90681|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90682|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90683|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90684|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90685|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90686|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90687|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90688|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90689|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90690|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90691|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90692|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90693|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90694|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90695|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90696|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90697|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90698|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90699|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
90700|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
90714|NCT01837550|B2|Baseline|Control Group|"no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
90715|NCT01837550|B1|Baseline|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
90716|NCT01837550|P2|Participant Flow|Control Group|"no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
90717|NCT01837550|P1|Participant Flow|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
90718|NCT01837550|O2|Outcome|Control Group|"no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
90719|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
90720|NCT01837550|O2|Outcome|Control Group|"no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
90721|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
90722|NCT01837550|O2|Outcome|Control Group|"no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
90723|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
90724|NCT01837550|O2|Outcome|Control Group|"no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
90725|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
90726|NCT01837550|E2|Reported Event|Control Group|"no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
90727|NCT01837550|E1|Reported Event|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
90728|NCT01837537|B1|Baseline|no Treatment|no treatment, prospective observational
90729|NCT01837537|P1|Participant Flow|no Treatment|no treatment, prospective observational
90730|NCT01837537|O1|Outcome|no Treatment|no treatment, prospective observational
90731|NCT01837537|O1|Outcome|no Treatment|no treatment, prospective observational
90732|NCT01837537|E1|Reported Event|no Treatment|no treatment, prospective observational
90733|NCT01837524|B3|Baseline|Total|Total of all reporting groups
90780|NCT01836523|B4|Baseline|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
90781|NCT01836523|B3|Baseline|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90806|NCT01836523|E2|Reported Event|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90856|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
90734|NCT01837524|B2|Baseline|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.
In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
90735|NCT01837524|B1|Baseline|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.
KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
90736|NCT01837524|P2|Participant Flow|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.
In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
90737|NCT01837524|P1|Participant Flow|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.
KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
90738|NCT01837524|O2|Outcome|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.
In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
90739|NCT01837524|O1|Outcome|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.
KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
90740|NCT01837524|E2|Reported Event|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.
In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
90782|NCT01836523|B2|Baseline|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90783|NCT01836523|B1|Baseline|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
90840|NCT01836471|E2|Reported Event|Fluticasone 150 mcg Bid|Fluticasone 150 mcg bid
90741|NCT01837524|E1|Reported Event|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.
KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
90742|NCT01836809|B5|Baseline|Total|Total of all reporting groups
90743|NCT01836809|B4|Baseline|LVAD: Placebo|"Control arm of the LVAD group
randomized to placebo"
90744|NCT01836809|B3|Baseline|LVAD: Nesiritide|"Active arm of the LVAD group
randomized to nesiritide"
90745|NCT01836809|B2|Baseline|Total Artificial Heart: Placebo|"Total Artificial Heart group
randomized to placebo"
90746|NCT01836809|B1|Baseline|Total Artificial Heart|"Active arm of the Total Artificial Heart group
randomized to nesiritide"
90747|NCT01836809|P4|Participant Flow|LVAD: Placebo|This arm will consist of subjects who received an LVAD and will be randomized to placebo
90748|NCT01836809|P3|Participant Flow|LVAD: Nesiritide|"Active arm of the LVAD group
randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
90749|NCT01836809|P2|Participant Flow|Total Artificial Heart: Placebo|This arm included subject who received a total artificial heart and will be randomized receive placebo
90750|NCT01836809|P1|Participant Flow|Total Artificial Heart|"Active arm of Total Artificial Heart group
randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
90751|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
90752|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group
nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
90753|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
90754|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide
nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
90755|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
90756|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group
nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
90757|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
90758|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide
nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
90759|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
90760|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group
nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
90761|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
90762|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide
nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
90763|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
90764|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group
nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
90765|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
90766|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide
nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
90767|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
90768|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group
nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
90769|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
90770|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide
nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
90771|NCT01836809|O4|Outcome|LVAD: Placebo|"Active arm of the LVAD group
randomized to receive placebo"
90772|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group
randomized to receive nesiritide"
90773|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|"Control arm of the Total Artificial Heart group
randomized to receive placebo"
90774|NCT01836809|O1|Outcome|Total Artificial Heart|"Active arm of the Total Artificial Heart group
randomized to receive nesiritide"
90775|NCT01836809|E4|Reported Event|LVAD: Placebo|"Control arm of the LVAD group
randomized to receive placebo"
90776|NCT01836809|E3|Reported Event|LVAD: Nesiritide|"Active arm of the LVAD group
randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
90777|NCT01836809|E2|Reported Event|Total Artificial Heart: Placebo|"Control arm of the Total Artificial Heart group
randomized to receive placebo"
90778|NCT01836809|E1|Reported Event|Total Artificial Heart|"Active arm of the Total Artificial Heart group
randomized to receive nesiritide 0.005 mcg/kg/min without bolus"
90784|NCT01836523|P4|Participant Flow|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
90785|NCT01836523|P3|Participant Flow|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90786|NCT01836523|P2|Participant Flow|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90787|NCT01836523|P1|Participant Flow|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
90788|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
90789|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90790|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90791|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
90792|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
90793|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90794|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90795|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
90796|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
90797|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90798|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90799|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
90800|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
90801|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90802|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90803|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
90804|NCT01836523|E4|Reported Event|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
90805|NCT01836523|E3|Reported Event|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
90807|NCT01836523|E1|Reported Event|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
90808|NCT01836471|B6|Baseline|Total|Total of all reporting groups
90809|NCT01836471|B5|Baseline|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90810|NCT01836471|B4|Baseline|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90811|NCT01836471|B3|Baseline|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90812|NCT01836471|B2|Baseline|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90813|NCT01836471|B1|Baseline|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90814|NCT01836471|P5|Participant Flow|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90815|NCT01836471|P4|Participant Flow|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90816|NCT01836471|P3|Participant Flow|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90817|NCT01836471|P2|Participant Flow|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90818|NCT01836471|P1|Participant Flow|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90819|NCT01836471|O5|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90820|NCT01836471|O4|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90821|NCT01836471|O3|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90822|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90823|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90824|NCT01836471|O5|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90825|NCT01836471|O4|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90826|NCT01836471|O3|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90827|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90828|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90829|NCT01836471|O5|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90830|NCT01836471|O4|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90831|NCT01836471|O3|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90832|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90833|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90834|NCT01836471|O3|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90835|NCT01836471|O2|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90836|NCT01836471|O1|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
90837|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90838|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
90839|NCT01836471|E3|Reported Event|Placebo|Placebo
90847|NCT01836458|P4|Participant Flow|Dose 4: 15 mg|Single dose of KAE609 15 mg
90848|NCT01836458|P3|Participant Flow|Dose 3: 10 mg|Single dose of KAE609 10 mg
90857|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
90867|NCT01836458|E4|Reported Event|Dose 4: 15mg|Single dose of KAE609 15 mg
90868|NCT01836458|E3|Reported Event|Dose 3: 10mg|Single dose of KAE609 10 mg
90869|NCT01836458|E2|Reported Event|Dose 2: 20mg|Single dose of KAE609 20 mg
90870|NCT01836458|E1|Reported Event|Dose 1: 30mg|Single dose of KAE609 30 mg
90871|NCT01836133|B1|Baseline|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
90872|NCT01836133|P1|Participant Flow|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
90873|NCT01836133|O1|Outcome|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
90874|NCT01836133|O1|Outcome|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
90875|NCT01836133|O1|Outcome|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
90876|NCT01836133|E1|Reported Event|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
90877|NCT01836042|B4|Baseline|Total|Total of all reporting groups
90878|NCT01836042|B3|Baseline|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
90879|NCT01836042|B2|Baseline|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
90880|NCT01836042|B1|Baseline|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
90881|NCT01836042|P3|Participant Flow|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
90882|NCT01836042|P2|Participant Flow|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
90883|NCT01836042|P1|Participant Flow|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
90884|NCT01836042|O3|Outcome|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
90885|NCT01836042|O2|Outcome|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
90886|NCT01836042|O1|Outcome|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
90887|NCT01836042|E3|Reported Event|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
90888|NCT01836042|E2|Reported Event|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
90889|NCT01836042|E1|Reported Event|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
90890|NCT01835912|B1|Baseline|All Study Participants|"Acute: dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
Acute Placebo: 500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
Chronic: 3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
Chronic Placebo: 3 days of 500 milliliters flavoured water and the 4th day 500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)"
90891|NCT01835912|P1|Participant Flow|All Study Participants|"Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic) and their corresponding placebos.
4 arms: Acute, Acute Placebo, Chronic, Chronic Placebo
Acute: 0.5 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water
Acute Placebo: 500 milliliters of flavoured water
Chronic: 3 days of 0.1 g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water
Chronic Placebo: 3 days of 500 millilitres of flavoured water and 4th day 500 millilitres of flavoured water"
90892|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
90893|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
90955|NCT01835496|B1|Baseline|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
90894|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
90895|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
90896|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
90897|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
90898|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
90899|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
90900|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
90901|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
90902|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
90903|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
90904|NCT01835912|E4|Reported Event|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
90905|NCT01835912|E3|Reported Event|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
90906|NCT01835912|E2|Reported Event|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
90907|NCT01835912|E1|Reported Event|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
90908|NCT01835899|B4|Baseline|Total|Total of all reporting groups
90909|NCT01835899|B3|Baseline|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
90910|NCT01835899|B2|Baseline|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
90911|NCT01835899|B1|Baseline|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
90912|NCT01835899|P3|Participant Flow|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
90913|NCT01835899|P2|Participant Flow|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
90914|NCT01835899|P1|Participant Flow|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
90915|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
90916|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
90917|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
90918|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
90919|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
90920|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
90921|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
90922|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
90923|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
90924|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
90925|NCT01835899|O3|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
90926|NCT01835899|O2|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
90927|NCT01835899|O1|Outcome|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
90928|NCT01835899|E3|Reported Event|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
90929|NCT01835899|E2|Reported Event|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
91079|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
90930|NCT01835899|E1|Reported Event|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
90931|NCT01835756|B3|Baseline|Total|Total of all reporting groups
90932|NCT01835756|B2|Baseline|Placebo Laser|The Placebo Laser has the same appearance and treatment application as the Erchonia MLS but does not emit any therapeutic light.
90933|NCT01835756|B1|Baseline|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
90934|NCT01835756|P2|Participant Flow|Placebo Laser|The Placebo Laser has the same appearance as the Erchonia MLS but does not emit any therapeutic light.
90935|NCT01835756|P1|Participant Flow|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. It is applied to the lower back and hips area for 30 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
90936|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
90937|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
90938|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
90939|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
90940|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the active Erchonia MLS but does not emit any therapeutic light.
90941|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light, applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
90942|NCT01835756|E2|Reported Event|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
90943|NCT01835756|E1|Reported Event|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light applied to the lower back and hips area for 30 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
90944|NCT01835743|B3|Baseline|Total|Total of all reporting groups
90945|NCT01835743|B2|Baseline|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.
Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
90946|NCT01835743|B1|Baseline|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.
Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
90947|NCT01835743|P2|Participant Flow|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.
Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
90948|NCT01835743|P1|Participant Flow|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.
Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
90949|NCT01835743|O2|Outcome|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.
Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
90950|NCT01835743|O1|Outcome|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.
Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
90951|NCT01835743|O2|Outcome|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.
Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
90952|NCT01835743|O1|Outcome|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.
Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
90953|NCT01835743|E2|Reported Event|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.
Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
90954|NCT01835743|E1|Reported Event|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.
Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
90956|NCT01835496|P1|Participant Flow|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
90957|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
90958|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
90959|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
90960|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
90961|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
90962|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
90963|NCT01835496|E1|Reported Event|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
90964|NCT01835470|B1|Baseline|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
90990|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
90965|NCT01835470|P1|Participant Flow|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
90966|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
90967|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
90968|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
90969|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
90970|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
90971|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
90972|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
90973|NCT01835470|E1|Reported Event|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
90974|NCT01835431|B3|Baseline|Total|Total of all reporting groups
90975|NCT01835431|B2|Baseline|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
90976|NCT01835431|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
90977|NCT01835431|P2|Participant Flow|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
90978|NCT01835431|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
90979|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
90980|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
90981|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
90982|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
90983|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
90984|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
90985|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
90986|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
90987|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
90988|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
90989|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
91095|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
90991|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
90992|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
90993|NCT01835431|E2|Reported Event|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
90994|NCT01835431|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
90995|NCT01835379|B3|Baseline|Total|Total of all reporting groups
90996|NCT01835379|B2|Baseline|Standard|"Standard Care
Standard Care as chosen by the Investigator"
90997|NCT01835379|B1|Baseline|Oasis|"Oasis
Oasis Ultra applied once per week for up to 12 weeks."
90998|NCT01835379|P2|Participant Flow|Standard|"Standard Care
Standard Care as chosen by the Investigator"
90999|NCT01835379|P1|Participant Flow|Oasis|"Oasis
Oasis Ultra applied once per week for up to 12 weeks."
91000|NCT01835379|O2|Outcome|Standard|"Standard Care
Standard Care as chosen by the Investigator"
91001|NCT01835379|O1|Outcome|Oasis|"Oasis
Oasis Ultra applied once per week for up to 12 weeks."
91002|NCT01835379|O2|Outcome|Standard|"Standard Care
Standard Care as chosen by the Investigator"
91003|NCT01835379|O1|Outcome|Oasis|"Oasis
Oasis Ultra applied once per week for up to 12 weeks."
91004|NCT01835379|E2|Reported Event|Standard|"Standard Care
Standard Care as chosen by the Investigator"
91005|NCT01835379|E1|Reported Event|Oasis|"Oasis
Oasis Ultra applied once per week for up to 12 weeks."
91006|NCT01835262|B3|Baseline|Total|Total of all reporting groups
91007|NCT01835262|B2|Baseline|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP
Ketamine: Ketamine:0.3 mg/given as IVP"
91008|NCT01835262|B1|Baseline|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP
Morphine: Morphine: 0.1 mg /kg given as IVP"
91009|NCT01835262|P2|Participant Flow|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP
Ketamine: Ketamine:0.3 mg/given as IVP"
91010|NCT01835262|P1|Participant Flow|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP
Morphine: Morphine: 0.1 mg /kg given as IVP"
91011|NCT01835262|O2|Outcome|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP
Ketamine: Ketamine:0.3 mg/given as IVP"
91012|NCT01835262|O1|Outcome|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP
Morphine: Morphine: 0.1 mg /kg given as IVP"
91013|NCT01835262|E2|Reported Event|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP
Ketamine: Ketamine:0.3 mg/given as IVP"
91014|NCT01835262|E1|Reported Event|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP
Morphine: Morphine: 0.1 mg /kg given as IVP"
91015|NCT01835132|B1|Baseline|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91016|NCT01835132|P1|Participant Flow|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91017|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91018|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91019|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91020|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91021|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91022|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91023|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91024|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91025|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91026|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91027|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91028|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91029|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91030|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91031|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91032|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91033|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91034|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91035|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91036|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91037|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91038|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91039|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91040|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91041|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91042|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91043|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91044|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91045|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91046|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91047|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91048|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91049|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91050|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91051|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91052|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91053|NCT01835132|E1|Reported Event|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab
Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
91054|NCT01835015|B6|Baseline|Total|Total of all reporting groups
91055|NCT01835015|B5|Baseline|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91056|NCT01835015|B4|Baseline|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91057|NCT01835015|B3|Baseline|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91058|NCT01835015|B2|Baseline|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91059|NCT01835015|B1|Baseline|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91060|NCT01835015|P5|Participant Flow|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91061|NCT01835015|P4|Participant Flow|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91062|NCT01835015|P3|Participant Flow|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91063|NCT01835015|P2|Participant Flow|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91064|NCT01835015|P1|Participant Flow|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91065|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91066|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91067|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91068|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91069|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91070|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91071|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91072|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91073|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91074|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91075|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91076|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91077|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91078|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91080|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91081|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91082|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91083|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91084|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91085|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91086|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91087|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91088|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91089|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91090|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91091|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91092|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91093|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91094|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91096|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91097|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91098|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91099|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91100|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91101|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91102|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91103|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91104|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91105|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91106|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91107|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91108|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91109|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91110|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91111|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91112|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91113|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91114|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91115|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91116|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91117|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91118|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91119|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91120|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91121|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91122|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91123|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91124|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91125|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
91126|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
91127|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
91128|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
91129|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
91130|NCT01835015|E6|Reported Event|Pretreatment|Reported prior to the initiation of study treatment
91131|NCT01835015|E5|Reported Event|CLG561, Level E|Reported subsequent to the initiation of treatment
91132|NCT01835015|E4|Reported Event|CLG561, Level D|Reported subsequent to the initiation of treatment
91133|NCT01835015|E3|Reported Event|CLG561, Level C|Reported subsequent to the initiation of treatment
91134|NCT01835015|E2|Reported Event|CLG561, Level B|Reported subsequent to the initiation of treatment
91135|NCT01835015|E1|Reported Event|CLG561, Level A|Reported subsequent to the initiation of treatment
91136|NCT01834404|B3|Baseline|Total|Total of all reporting groups
91137|NCT01834404|B2|Baseline|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91138|NCT01834404|B1|Baseline|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91139|NCT01834404|P2|Participant Flow|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91140|NCT01834404|P1|Participant Flow|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91141|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91142|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91143|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91144|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91145|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91950|NCT01830855|B2|Baseline|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
91146|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91147|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91148|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91149|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91150|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91151|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91152|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91153|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91154|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91155|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91156|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91157|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91158|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91159|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91160|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91161|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91162|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91163|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91164|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91165|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91200|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
91166|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91167|NCT01834404|E2|Reported Event|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
91168|NCT01834404|E1|Reported Event|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
91169|NCT01834274|B3|Baseline|Total|Total of all reporting groups
91170|NCT01834274|B2|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
91171|NCT01834274|B1|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
91172|NCT01834274|P2|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
91951|NCT01830855|B1|Baseline|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91173|NCT01834274|P1|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
91174|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
91175|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
91176|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
91177|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
91178|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
91179|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
91180|NCT01834274|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
91181|NCT01834274|E1|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
91182|NCT01834261|B3|Baseline|Total|Total of all reporting groups
91183|NCT01834261|B2|Baseline|Placebo, Then Oxytocin|"Healthy adult subjects received several puffs of Syntocinon Placebo Formulation, 40IU, once, prior to MRI and/or MEG scanning.
This group contains subjects who received placebo prior to first scan and oxytocin prior to second scan."
91184|NCT01834261|B1|Baseline|Oxytocin, Then Placebo|"Healthy adult subjects received several puffs of Syntocinon Nasal Spray, 40IU, once, prior to MRI and/or MEG scanning.
This group contains subjects who received oxytocin prior to first scan and placebo prior to second scan."
91185|NCT01834261|P2|Participant Flow|Placebo, Then Oxytocin|Healthy adult subjects who received placebo before their first scan, and oxytocin before their second scan.
91186|NCT01834261|P1|Participant Flow|Oxytocin, Then Placebo|Healthy adult subjects who received oxytocin before their first scan, and placebo before their second scan.
91187|NCT01834261|O2|Outcome|Placebo|Subjects received placebo prior to the scan.
91188|NCT01834261|O1|Outcome|Oxytocin|Subjects received oxytocin prior to the scan.
91189|NCT01834261|O2|Outcome|Placebo|Subjects received placebo prior to the scan.
91190|NCT01834261|O1|Outcome|Oxytocin|Subjects received oxytocin prior to the scan.
91191|NCT01834261|O2|Outcome|Placebo|Subjects received placebo prior to the scan.
91192|NCT01834261|O1|Outcome|Oxytocin|Subjects received oxytocin prior to the scan.
91193|NCT01834261|E2|Reported Event|Placebo, Then Oxytocin|Subjects who received placebo before their first scan, and oxytocin before their second scan.
91194|NCT01834261|E1|Reported Event|Oxytocin, Then Placebo|Subjects who received oxytocin before their first scan, and placebo before their second scan.
91195|NCT01834222|B1|Baseline|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
91196|NCT01834222|P1|Participant Flow|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 milliliter (mL) intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
91197|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
91198|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
91199|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
91294|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91201|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
91202|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
91203|NCT01834222|E1|Reported Event|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
91204|NCT01834027|B3|Baseline|Total|Total of all reporting groups
91205|NCT01834027|B2|Baseline|No Music|"The patients in this group will have noise-cancelling headphones but no music will be played.
No music: In this group, noise-cancelling headphones will be worn, but no music will be played in PACU"
91206|NCT01834027|B1|Baseline|Jazz Music|"Jazz music will be played through noise-cancelling headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
91207|NCT01834027|P2|Participant Flow|No Music|"The patients in this group with have headphones but no music will be played.
No music: In this group nu music will be played in PACU"
92013|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91208|NCT01834027|P1|Participant Flow|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
91209|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.
No music: In this group nu music will be played in PACU"
91210|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
91211|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.
No music: In this group nu music will be played in PACU"
91212|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
91213|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.
No music: In this group nu music will be played in PACU"
91214|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
91215|NCT01834027|E2|Reported Event|No Music|"The patients in this group with have headphones but no music will be played.
No music: In this group nu music will be played in PACU"
91216|NCT01834027|E1|Reported Event|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
91217|NCT01833988|B1|Baseline|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
91218|NCT01833988|P2|Participant Flow|Usual Care Then Bionic Pancreas|"Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy.
In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 2 day washout period in between."
91219|NCT01833988|P1|Participant Flow|Bionic Pancreas Then Usual Care|"Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy.
In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 2 day washout period in between."
91220|NCT01833988|O2|Outcome|Control|
91221|NCT01833988|O1|Outcome|Bionic Pancreas|
91222|NCT01833988|O2|Outcome|Control|
91223|NCT01833988|O1|Outcome|Bionic Pancreas|
91224|NCT01833988|O2|Outcome|Control|
91225|NCT01833988|O1|Outcome|Bionic Pancreas|
91226|NCT01833988|O1|Outcome|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
91227|NCT01833988|O1|Outcome|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
91228|NCT01833988|O2|Outcome|Control|
91229|NCT01833988|O1|Outcome|Bionic Pancreas|
91230|NCT01833988|O2|Outcome|Control|
91231|NCT01833988|O1|Outcome|Bionic Pancreas|
91232|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
92827|NCT01826604|B1|Baseline|Alexis O C-section Retractor|Alexis O retractor used during C-section
91233|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91234|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91235|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91236|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91237|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91238|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91239|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91240|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91241|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91242|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91243|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91244|NCT01833988|O1|Outcome|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
91245|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91246|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91247|NCT01833988|O1|Outcome|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
91248|NCT01833988|O1|Outcome|All Study Participants|The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
91249|NCT01833988|O2|Outcome|Control|
91250|NCT01833988|O1|Outcome|Bionic Pancreas|
91251|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91252|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91253|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91254|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91255|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91256|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91257|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91258|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91259|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91260|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91261|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91262|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91263|NCT01833988|O2|Outcome|Usual Care|"Usual Care
Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump."
91264|NCT01833988|O1|Outcome|Bi-hormonal Bionic Pancreas|"Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device."
91265|NCT01833988|O1|Outcome|Bionic Pancreas|"Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy.
In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 1 day washout period in between."
91266|NCT01833988|O2|Outcome|Standard Care (Insulin Pump)|
91267|NCT01833988|O1|Outcome|Bionic Pancreas|
91268|NCT01833988|O2|Outcome|Control|
91269|NCT01833988|O1|Outcome|Bionic Pancreas|
91270|NCT01833988|E2|Reported Event|Control|
91271|NCT01833988|E1|Reported Event|Bionic Pancreas|
93404|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
91272|NCT01833897|B1|Baseline|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
91273|NCT01833897|P1|Participant Flow|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
91274|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
91301|NCT01833533|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
91275|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
91276|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
91277|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
91278|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
91279|NCT01833897|E1|Reported Event|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
91280|NCT01833845|B1|Baseline|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).
Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.
Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
91281|NCT01833845|P1|Participant Flow|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).
Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.
Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
91282|NCT01833845|O1|Outcome|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).
Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.
Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
91283|NCT01833845|E1|Reported Event|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).
Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.
Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
91284|NCT01833741|B1|Baseline|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91285|NCT01833741|P1|Participant Flow|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91286|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91287|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91288|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91289|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91290|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91291|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91292|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91293|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91295|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91296|NCT01833741|E1|Reported Event|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
91297|NCT01833533|B3|Baseline|Total|Total of all reporting groups
91298|NCT01833533|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
91299|NCT01833533|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
91300|NCT01833533|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
91302|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
91303|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
91304|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
91305|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
91306|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
91307|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
91308|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
91309|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
91310|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
91311|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
91312|NCT01833533|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
91313|NCT01833533|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
91314|NCT01833481|B4|Baseline|Total|Total of all reporting groups
91315|NCT01833481|B3|Baseline|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91316|NCT01833481|B2|Baseline|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91317|NCT01833481|B1|Baseline|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91318|NCT01833481|P3|Participant Flow|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91319|NCT01833481|P2|Participant Flow|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91320|NCT01833481|P1|Participant Flow|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91339|NCT01833247|P1|Participant Flow|Epilepsy Inpatients|Patients who have blood or salivary (or both) levels recorded after a seizure.
91321|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91322|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91323|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91557|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
91324|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91325|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91326|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91327|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91328|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91329|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91330|NCT01833481|E3|Reported Event|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91331|NCT01833481|E2|Reported Event|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91332|NCT01833481|E1|Reported Event|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
91333|NCT01833403|B1|Baseline|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp
Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery
Glucose"
91334|NCT01833403|P1|Participant Flow|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp
Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery
Glucose"
91335|NCT01833403|O1|Outcome|Measurement of Insulin Sensitivity|"All participants will undergo a hyperinsulinemic-euglycemic clamp to measure insulin sensitivity
Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery"
91336|NCT01833403|O1|Outcome|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp
Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery
Glucose"
91337|NCT01833403|E1|Reported Event|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp
Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery
Glucose"
91338|NCT01833247|B1|Baseline|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
91340|NCT01833247|O1|Outcome|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
91341|NCT01833247|O1|Outcome|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
91342|NCT01833247|O1|Outcome|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
91343|NCT01833247|E1|Reported Event|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
91344|NCT01833130|B3|Baseline|Total|Total of all reporting groups
91345|NCT01833130|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91346|NCT01833130|B1|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91347|NCT01833130|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91558|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
91348|NCT01833130|P1|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91349|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91350|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91351|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91352|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91353|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91354|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91355|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91356|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91357|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91358|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91359|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91360|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91361|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91362|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91363|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91364|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91365|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91366|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91367|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91368|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91369|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91370|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91371|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91372|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91373|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91374|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91375|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91420|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91376|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91377|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91378|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91379|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91380|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91381|NCT01833130|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91382|NCT01833130|E1|Reported Event|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
91383|NCT01833117|B3|Baseline|Total|Total of all reporting groups
91384|NCT01833117|B2|Baseline|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
91385|NCT01833117|B1|Baseline|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
91386|NCT01833117|P2|Participant Flow|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
91387|NCT01833117|P1|Participant Flow|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
91388|NCT01833117|O2|Outcome|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
91389|NCT01833117|O1|Outcome|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
91390|NCT01833117|O2|Outcome|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
91391|NCT01833117|O1|Outcome|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
91392|NCT01833117|E2|Reported Event|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
91393|NCT01833117|E1|Reported Event|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
91394|NCT01833078|B1|Baseline|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
91395|NCT01833078|P1|Participant Flow|Ghrelin|All participants received 7.5 mcg/kg of ghrelin as a once daily subcutaneous dose for seven consecutive days. Days 1, 2 and 7 will be in the research center. Days 3,4,5,and 6 will be self administered at home.
91396|NCT01833078|O1|Outcome|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
91397|NCT01833078|O1|Outcome|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
91398|NCT01833078|E1|Reported Event|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
91399|NCT01833065|B4|Baseline|Total|Total of all reporting groups
91400|NCT01833065|B3|Baseline|PLCBO|Placebo was administered orally in a tablet form.
91401|NCT01833065|B2|Baseline|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form.
91402|NCT01833065|B1|Baseline|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form.
91403|NCT01833065|P5|Participant Flow|PLCBO/EBX 10|Patients in this arm received placebo during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
91404|NCT01833065|P4|Participant Flow|EBX 5/PLCBO|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
91405|NCT01833065|P3|Participant Flow|EBX 5/EBX 5|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
91406|NCT01833065|P2|Participant Flow|EBX 10/PLCBO|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
91407|NCT01833065|P1|Participant Flow|EBX 10/EBX 10|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
91408|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91409|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91410|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91411|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91412|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91413|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91414|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91415|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91416|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91417|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91418|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91419|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91421|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91422|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91423|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91424|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91425|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91426|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91427|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91428|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91429|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91430|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91431|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
91432|NCT01833065|E5|Reported Event|PLCBO/EBX 10|Patients in this arm received placebo during the 12-week Treatment Period and received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
91433|NCT01833065|E4|Reported Event|EBX 5/PLCBO|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
91434|NCT01833065|E3|Reported Event|EBX 5/EBX 5|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period.
91435|NCT01833065|E2|Reported Event|EBX 10/PLCBO|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
91436|NCT01833065|E1|Reported Event|EBX 10/EBX 10|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
91437|NCT01832766|B1|Baseline|Entire Study Population|includes groups randomized to receive placebo first or dronabinol 10 mg first
91438|NCT01832766|P2|Participant Flow|Placebo First Then 10 mg Dronabinol|identical capsule given orally once in first intervention period then 1 week washout period then dronabinol 10 mg given orally once in second intervention period
91439|NCT01832766|P1|Participant Flow|Dronabinol 10 mg First Then Placebo|dronabinol 10 mg given oral one dose in first intervention period then 1 week washout period and then placebo given oral in one dose in second intervention period
91440|NCT01832766|O2|Outcome|Placebo|identical capsule given once
91441|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
91442|NCT01832766|O2|Outcome|Placebo|identical capsule given once
91443|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
91444|NCT01832766|O2|Outcome|Placebo|identical capsule given once
91445|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
91446|NCT01832766|E2|Reported Event|Placebo|identical capsule given once
91447|NCT01832766|E1|Reported Event|Dronabinol|dronabinol 10 mg given oral one dose
91448|NCT01832506|B4|Baseline|Total|Total of all reporting groups
91449|NCT01832506|B3|Baseline|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91450|NCT01832506|B2|Baseline|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91451|NCT01832506|B1|Baseline|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91452|NCT01832506|P3|Participant Flow|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91453|NCT01832506|P2|Participant Flow|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91454|NCT01832506|P1|Participant Flow|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 milligram (mg) orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91455|NCT01832506|O1|Outcome|MSC2156119J Combined|All subjects who were administered with MSC2156119J 215 mg, 300mg or 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91456|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91457|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91458|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91459|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91460|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91461|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91462|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91463|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91464|NCT01832506|O1|Outcome|MSC2156119J 200 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91465|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91466|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91467|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91468|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91469|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91470|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91471|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91472|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91473|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91474|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91475|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91476|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91477|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91478|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91479|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91480|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91481|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91482|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91483|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91484|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91485|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91486|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91487|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91488|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91489|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91490|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91491|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91492|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91493|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91494|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91495|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91496|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91497|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91498|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91499|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91500|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91501|NCT01832506|E3|Reported Event|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91502|NCT01832506|E2|Reported Event|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91503|NCT01832506|E1|Reported Event|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
91504|NCT01832493|B1|Baseline|Cardiac Resynchronization Therapy Patients|All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
91505|NCT01832493|P1|Participant Flow|Cardiac Resynchronization Therapy Patients|All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
91506|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device
Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
91507|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device
Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
91508|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device
Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
91509|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device
Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
91510|NCT01832493|E1|Reported Event|All Enrolled Patients|Adverse events were collected and are reported for all 50 enrolled patients
91511|NCT01832155|B3|Baseline|Total|Total of all reporting groups
91512|NCT01832155|B2|Baseline|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91513|NCT01832155|B1|Baseline|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.
Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
91514|NCT01832155|P2|Participant Flow|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91515|NCT01832155|P1|Participant Flow|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.
Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
91516|NCT01832155|O1|Outcome|All Participants|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91517|NCT01832155|O2|Outcome|Yoga Intervention Group|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91518|NCT01832155|O1|Outcome|Wait-list Control Group|Participants in the control group received the same Hatha yoga program at the end of 8 weeks when the intervention group completed their intervention classes.
91519|NCT01832155|O1|Outcome|Both Groups During Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91520|NCT01832155|O1|Outcome|About the Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91521|NCT01832155|O1|Outcome|All Participants|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91548|NCT01831817|B1|Baseline|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91549|NCT01831817|P4|Participant Flow|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
91522|NCT01832155|O1|Outcome|Class Rentention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91523|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91524|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.
Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
91525|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91526|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.
Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
91527|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91528|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.
Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
91529|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91530|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.
Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
91531|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91532|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.
Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
91533|NCT01832155|E2|Reported Event|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
91534|NCT01832155|E1|Reported Event|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.
Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
91535|NCT01831934|B3|Baseline|Total|Total of all reporting groups
91536|NCT01831934|B2|Baseline|Control Group|"Fluzone®
Fluzone®"
91537|NCT01831934|B1|Baseline|MELAS Group|"Fluzone®
Fluzone®"
91538|NCT01831934|P2|Participant Flow|Control Group: 18-65 Years of Age|"Fluzone® 2011-2012 Formula
Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses."
91539|NCT01831934|P1|Participant Flow|MELAS Group:13-60 Years of Age.|"Fluzone® 2011-2012 Formula
Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses."
91540|NCT01831934|O2|Outcome|Control Group|"Fluzone® 2011-2012 Formula
Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly"
91541|NCT01831934|O1|Outcome|MELAS Group|"Fluzone® 2011-2012 Formula
Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly"
91542|NCT01831934|E2|Reported Event|Control Group|"Fluzone®
Fluzone®"
91543|NCT01831934|E1|Reported Event|MELAS Group|"Fluzone®
Fluzone®"
91544|NCT01831817|B5|Baseline|Total|Total of all reporting groups
91545|NCT01831817|B4|Baseline|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
91546|NCT01831817|B3|Baseline|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
91547|NCT01831817|B2|Baseline|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91794|NCT01831219|B3|Baseline|Total|Total of all reporting groups
91550|NCT01831817|P3|Participant Flow|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
91551|NCT01831817|P2|Participant Flow|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91552|NCT01831817|P1|Participant Flow|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91553|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
91554|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
91555|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91556|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91559|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91560|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91561|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
91562|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
91563|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91564|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91565|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
91566|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
91567|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91568|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91569|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
91570|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
91571|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91572|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91573|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
91574|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
91575|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91576|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91577|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
91578|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
91579|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91580|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91581|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
91582|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
91583|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91584|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91585|NCT01831817|E4|Reported Event|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
91586|NCT01831817|E3|Reported Event|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
91587|NCT01831817|E2|Reported Event|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91588|NCT01831817|E1|Reported Event|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|DDentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
91589|NCT01831791|B1|Baseline|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91590|NCT01831791|P1|Participant Flow|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91591|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
93463|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
91592|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91593|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91594|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91595|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91596|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91597|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91598|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91599|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91600|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91601|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91602|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91603|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91604|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91605|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91606|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91607|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91608|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91609|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91610|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91611|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91612|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91613|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91614|NCT01831791|E1|Reported Event|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
91615|NCT01831726|B1|Baseline|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
91616|NCT01831726|P1|Participant Flow|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
91617|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
91618|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
91619|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
91620|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
91621|NCT01831726|E1|Reported Event|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
91622|NCT01831466|B13|Baseline|Total|Total of all reporting groups
91623|NCT01831466|B12|Baseline|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
91624|NCT01831466|B11|Baseline|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91625|NCT01831466|B10|Baseline|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91626|NCT01831466|B9|Baseline|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
91627|NCT01831466|B8|Baseline|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91628|NCT01831466|B7|Baseline|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91629|NCT01831466|B6|Baseline|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91630|NCT01831466|B5|Baseline|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91631|NCT01831466|B4|Baseline|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91632|NCT01831466|B3|Baseline|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91633|NCT01831466|B2|Baseline|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91634|NCT01831466|B1|Baseline|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91635|NCT01831466|P12|Participant Flow|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
91636|NCT01831466|P11|Participant Flow|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91637|NCT01831466|P10|Participant Flow|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91638|NCT01831466|P9|Participant Flow|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
91639|NCT01831466|P8|Participant Flow|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91640|NCT01831466|P7|Participant Flow|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91641|NCT01831466|P6|Participant Flow|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91642|NCT01831466|P5|Participant Flow|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91643|NCT01831466|P4|Participant Flow|Mild/Moderate: Tofacitinib 20 mg/g Once Daily (QD)|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91644|NCT01831466|P3|Participant Flow|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91645|NCT01831466|P2|Participant Flow|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91646|NCT01831466|P1|Participant Flow|Mild/Moderate: Tofacitinib 20 mg/Gram (mg/g) Twice Daily (BID)|Participants with a baseline Calculated Physician’s Global Assessment (PGA-C) score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91647|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91648|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91649|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91650|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91651|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91652|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91653|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91654|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91655|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91656|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91657|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91658|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91659|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91660|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91661|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91662|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91663|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91664|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91665|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91666|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91667|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91668|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91669|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91670|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91671|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
93464|NCT01822535|O2|Outcome|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
91672|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91673|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91674|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91675|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91676|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91677|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91851|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
91678|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91679|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91680|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91681|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91682|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91683|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91684|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91685|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91686|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91687|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91688|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91689|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91690|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91691|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91692|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91693|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91694|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91695|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91696|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91697|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91698|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91699|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91700|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91701|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91702|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91703|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91704|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91705|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91706|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91707|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91708|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91709|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91710|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91711|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91712|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91713|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91714|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91715|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91716|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91717|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91718|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91719|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91720|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91721|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91722|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91723|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91724|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91725|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91726|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91727|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91728|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91729|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91730|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91731|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91732|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91733|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91734|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91735|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91736|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91737|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91738|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91739|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91740|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91741|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91742|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91743|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91744|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91745|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91746|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91747|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91748|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91749|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91750|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91751|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91752|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91753|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91754|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91755|NCT01831466|E12|Reported Event|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
91756|NCT01831466|E11|Reported Event|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91757|NCT01831466|E10|Reported Event|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91758|NCT01831466|E9|Reported Event|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
91759|NCT01831466|E8|Reported Event|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91760|NCT01831466|E7|Reported Event|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91761|NCT01831466|E6|Reported Event|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
91762|NCT01831466|E5|Reported Event|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
91763|NCT01831466|E4|Reported Event|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
91764|NCT01831466|E3|Reported Event|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
91765|NCT01831466|E2|Reported Event|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
91766|NCT01831466|E1|Reported Event|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
91767|NCT01831258|B1|Baseline|All Study Participants|Participants who were randomized to receive either SensAwake On or SensAwake Off
91768|NCT01831258|P2|Participant Flow|SensAwake Off, Then Followed by SensAwake On|The comfort feature 'SensAwake' will be turned off, then followed by on.
91769|NCT01831258|P1|Participant Flow|SensAwake On, Then Followed by SensAwake Off|The comfort feature 'SensAwake' will be turned on, followed by it off.
91770|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
91771|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
91772|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
91773|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
91774|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
91775|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
91776|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
91777|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
91778|NCT01831258|O2|Outcome|SensAwake Off|"The comfort feature 'SensAwake' will be turned off
SensAwake Off"
91779|NCT01831258|O1|Outcome|SensAwake On|"The comfort feature 'SensAwake' will be turned on
SensAwake On"
91780|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
91781|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
91782|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
91783|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
91784|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
91785|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
91786|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
91787|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
91788|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
91789|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
91790|NCT01831258|O2|Outcome|SensAwake Off|The comfort feature 'SensAwake' will be turned off
91791|NCT01831258|O1|Outcome|SensAwake On|The comfort feature 'SensAwake' will be turned on
91792|NCT01831258|E2|Reported Event|SensAwake Off|The comfort feature 'SensAwake' will be turned off
91793|NCT01831258|E1|Reported Event|SensAwake On|The comfort feature 'SensAwake' will be turned on
91795|NCT01831219|B2|Baseline|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
91796|NCT01831219|B1|Baseline|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
91797|NCT01831219|P2|Participant Flow|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
91798|NCT01831219|P1|Participant Flow|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
91799|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
92314|NCT01829230|O2|Outcome|Test Lens A|Test lens A from the previous study
91800|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
91801|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
91802|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
91803|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
91804|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
91805|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
91806|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
91807|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
91808|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
91809|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
91810|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
91811|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
91812|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
91813|NCT01831219|E2|Reported Event|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
91814|NCT01831219|E1|Reported Event|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical sys...
91815|NCT01831154|B4|Baseline|Total|Total of all reporting groups
91816|NCT01831154|B3|Baseline|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
91817|NCT01831154|B2|Baseline|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91818|NCT01831154|B1|Baseline|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.
Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91844|NCT01830933|B2|Baseline|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.
Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.
BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
91819|NCT01831154|P3|Participant Flow|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
91882|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91883|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution"
91820|NCT01831154|P2|Participant Flow|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91821|NCT01831154|P1|Participant Flow|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.
Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91822|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
91823|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91824|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.
Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91825|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
91826|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91845|NCT01830933|B1|Baseline|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
91846|NCT01830933|P2|Participant Flow|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.
Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.
BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
91850|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.
Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.
BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
91947|NCT01830855|B5|Baseline|Total|Total of all reporting groups
91827|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.
Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91828|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
91829|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91830|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.
Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91831|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
91832|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91833|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.
Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91834|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
91847|NCT01830933|P1|Participant Flow|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
91848|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.
Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.
BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
91835|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91836|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.
Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91837|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
91838|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91839|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.
Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91840|NCT01831154|E3|Reported Event|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
91841|NCT01831154|E2|Reported Event|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91842|NCT01831154|E1|Reported Event|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.
Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
91843|NCT01830933|B3|Baseline|Total|Total of all reporting groups
91849|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
91878|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution"
92002|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91852|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.
Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.
BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
91853|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
91854|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.
Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.
BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
91855|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
91856|NCT01830933|E2|Reported Event|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.
Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.
BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
91857|NCT01830933|E1|Reported Event|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
91858|NCT01830920|B6|Baseline|Total|Total of all reporting groups
91859|NCT01830920|B5|Baseline|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91860|NCT01830920|B4|Baseline|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91861|NCT01830920|B3|Baseline|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91862|NCT01830920|B2|Baseline|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91863|NCT01830920|B1|Baseline|Placebo|"An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution"
91864|NCT01830920|P5|Participant Flow|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91865|NCT01830920|P4|Participant Flow|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91866|NCT01830920|P3|Participant Flow|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91867|NCT01830920|P2|Participant Flow|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91868|NCT01830920|P1|Participant Flow|Placebo|"An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution"
91869|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91870|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91871|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91872|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91873|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution"
91874|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91875|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91876|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91877|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
92058|NCT01830790|B3|Baseline|Total|Total of all reporting groups
91879|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91880|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91881|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
92315|NCT01829230|O1|Outcome|Test Lens C|Test lens C from the previous study
91884|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91885|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91886|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91887|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91888|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution"
91889|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91890|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91891|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91892|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91893|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution"
91894|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91895|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91896|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91897|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91898|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution"
91899|NCT01830920|E5|Reported Event|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91900|NCT01830920|E4|Reported Event|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91901|NCT01830920|E3|Reported Event|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91902|NCT01830920|E2|Reported Event|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
91903|NCT01830920|E1|Reported Event|Placebo|"An identical appearing placebo will be administered.
Placebo: A normal saline solution identical in appearance to the active drug solution"
91904|NCT01830881|B3|Baseline|Total|Total of all reporting groups
91905|NCT01830881|B2|Baseline|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91906|NCT01830881|B1|Baseline|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91907|NCT01830881|P2|Participant Flow|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91908|NCT01830881|P1|Participant Flow|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
92001|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91909|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91910|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91948|NCT01830855|B4|Baseline|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91949|NCT01830855|B3|Baseline|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
91911|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91912|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91913|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91914|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91915|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91916|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91917|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91918|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91919|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91920|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91921|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91922|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91923|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91924|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91925|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91926|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91927|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91928|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91929|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91930|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91931|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91932|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91933|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91934|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91935|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91936|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91937|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91938|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91939|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91940|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91941|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91942|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91943|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91944|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91945|NCT01830881|E2|Reported Event|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91946|NCT01830881|E1|Reported Event|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
91952|NCT01830855|P4|Participant Flow|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91953|NCT01830855|P3|Participant Flow|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
91954|NCT01830855|P2|Participant Flow|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
91955|NCT01830855|P1|Participant Flow|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91956|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
91957|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
91958|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91959|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
91960|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
91961|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91962|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
91963|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
91964|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91965|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule.
91966|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule.
91967|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91968|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
91969|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
91970|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91971|NCT01830855|O2|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
91972|NCT01830855|O1|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
91973|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91974|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91975|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91976|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91977|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
91978|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91979|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91980|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91981|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91982|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91983|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91984|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91985|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91986|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91987|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91988|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91989|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91990|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91991|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91992|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91993|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91994|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91995|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91996|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91997|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
91998|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
91999|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92000|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92003|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92004|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92005|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92006|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92007|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92008|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92009|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92010|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92011|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92012|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92014|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92015|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92016|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92017|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92018|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92019|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92020|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92021|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92022|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92023|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92024|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92025|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92026|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92027|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92028|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92029|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92030|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92031|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92032|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92033|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92034|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92035|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92036|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92037|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92038|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92039|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92040|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92041|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92042|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92043|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92044|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92045|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92046|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92047|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92048|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92049|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
92050|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
92051|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
92052|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
92053|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
92054|NCT01830855|E4|Reported Event|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
92055|NCT01830855|E3|Reported Event|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
92056|NCT01830855|E2|Reported Event|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
92057|NCT01830855|E1|Reported Event|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
92059|NCT01830790|B2|Baseline|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
92060|NCT01830790|B1|Baseline|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
92061|NCT01830790|P2|Participant Flow|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
92062|NCT01830790|P1|Participant Flow|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
92308|NCT01829243|E1|Reported Event|Milnacipran|Adverse events in this group occurred while subjects were taking Milnacipran.
92309|NCT01829230|B3|Baseline|Total|Total of all reporting groups
92063|NCT01830790|O2|Outcome|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
92064|NCT01830790|O1|Outcome|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
92065|NCT01830790|O2|Outcome|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
92066|NCT01830790|O1|Outcome|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
92067|NCT01830790|E2|Reported Event|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
92068|NCT01830790|E1|Reported Event|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
92069|NCT01830699|B3|Baseline|Total|Total of all reporting groups
92070|NCT01830699|B2|Baseline|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once"
92071|NCT01830699|B1|Baseline|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )"
92072|NCT01830699|P2|Participant Flow|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once"
92073|NCT01830699|P1|Participant Flow|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )"
92074|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once"
92075|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )"
92076|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once"
92077|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )"
92078|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once"
92079|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )"
92080|NCT01830699|E2|Reported Event|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once"
92081|NCT01830699|E1|Reported Event|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )"
92082|NCT01830543|B4|Baseline|Total|Total of all reporting groups
92083|NCT01830543|B3|Baseline|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92084|NCT01830543|B2|Baseline|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92301|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
92085|NCT01830543|B1|Baseline|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92086|NCT01830543|P3|Participant Flow|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92310|NCT01829230|B2|Baseline|Test Lens A|Test lens A from previous study
92311|NCT01829230|B1|Baseline|Test Lens C|Test lens C from previous study
92087|NCT01830543|P2|Participant Flow|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92088|NCT01830543|P1|Participant Flow|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92089|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92090|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92091|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92092|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92093|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92094|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92095|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92096|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92097|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92098|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92124|NCT01830205|P4|Participant Flow|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92312|NCT01829230|P2|Participant Flow|Test Lens A|Test lens A from previous study
92099|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92100|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92101|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92102|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92103|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92104|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92105|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92106|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92107|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92108|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92109|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92157|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92379|NCT01828281|B3|Baseline|Total|Total of all reporting groups
92110|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92111|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92112|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92113|NCT01830543|O3|Outcome|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92114|NCT01830543|O2|Outcome|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92115|NCT01830543|O1|Outcome|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92116|NCT01830543|E3|Reported Event|Vitamin K Antagonist (VKA)|Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92117|NCT01830543|E2|Reported Event|Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)|Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
92118|NCT01830543|E1|Reported Event|Rivaroxaban 15 mg|Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
92119|NCT01830205|B5|Baseline|Total|Total of all reporting groups
92120|NCT01830205|B4|Baseline|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92121|NCT01830205|B3|Baseline|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92122|NCT01830205|B2|Baseline|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92137|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92123|NCT01830205|B1|Baseline|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92125|NCT01830205|P3|Participant Flow|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92126|NCT01830205|P2|Participant Flow|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92127|NCT01830205|P1|Participant Flow|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had estimated glomerular filtration rate (eGFR) 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92128|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92129|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92130|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92131|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92132|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92133|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92134|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92135|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92136|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92138|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92160|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92139|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92140|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92141|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92142|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92143|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92144|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92145|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92146|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
92147|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were re-randomized from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92148|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92149|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92150|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92151|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92152|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92153|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92154|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92155|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92156|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92267|NCT01829464|B3|Baseline|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92158|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92159|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92161|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92162|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92163|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92164|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92165|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92166|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92167|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92168|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92169|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92170|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92171|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92172|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92173|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92174|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92175|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92176|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92177|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92178|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92179|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92180|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92181|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92182|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92300|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking the Milnacipran.
92183|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92184|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92185|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
92186|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92187|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92188|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92189|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92190|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92191|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
92192|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92193|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
92194|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92195|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
92196|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92197|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92198|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92199|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) < 15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92200|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92201|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92202|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92203|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92204|NCT01830205|E4|Reported Event|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
92205|NCT01830205|E3|Reported Event|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92235|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92380|NCT01828281|B2|Baseline|Control|subtherapeutic CPAP using 4 cm water
92206|NCT01830205|E2|Reported Event|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92270|NCT01829464|P3|Participant Flow|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92207|NCT01830205|E1|Reported Event|Group-A|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
92208|NCT01830140|B3|Baseline|Total|Total of all reporting groups
92209|NCT01830140|B2|Baseline|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
92210|NCT01830140|B1|Baseline|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
92211|NCT01830140|P2|Participant Flow|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
92212|NCT01830140|P1|Participant Flow|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
92213|NCT01830140|O2|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
92214|NCT01830140|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
92215|NCT01830140|E2|Reported Event|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
92216|NCT01830140|E1|Reported Event|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
92217|NCT01830127|B3|Baseline|Total|Total of all reporting groups
92218|NCT01830127|B2|Baseline|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
92219|NCT01830127|B1|Baseline|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
92220|NCT01830127|P2|Participant Flow|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
92221|NCT01830127|P1|Participant Flow|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
92222|NCT01830127|O2|Outcome|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
92223|NCT01830127|O1|Outcome|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
92224|NCT01830127|O2|Outcome|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
92225|NCT01830127|O1|Outcome|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
92226|NCT01830127|E2|Reported Event|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
92227|NCT01830127|E1|Reported Event|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
92228|NCT01829919|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|"Brisdelle (paroxetine mesylate) Capsules
All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92229|NCT01829919|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92230|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92231|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92232|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92233|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92234|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92265|NCT01829477|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92266|NCT01829464|B4|Baseline|Total|Total of all reporting groups
92236|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92237|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92238|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92239|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92240|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92241|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92242|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92243|NCT01829919|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|"Brisdelle (paroxetine mesylate) Capsules
All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
92244|NCT01829516|B1|Baseline|All Study Participants|This is a crossover study of 39 moderate to heavy social alcohol users who will receive a single dose 40 IU of intranasal oxytocin followed by 40 IU of placebo or vice versa.
92245|NCT01829516|P2|Participant Flow|Placebo First Then Oxytocin|"14 moderate to heavy social alcohol users received a single dose 40 IU of intranasal placebo followed by a single dose 40 IU of intranasal oxytocin.
NOTE: This is a cross-over design and subjects will participate in both arms."
92246|NCT01829516|P1|Participant Flow|Oxytocin First, Then Placebo|"18 moderate to heavy social alcohol users received a single dose 40 IU of intranasal oxytocin followed by a single dose 40 IU of intranasal placebo.
NOTE: This is a cross-over design and subjects will participate in both arms."
92247|NCT01829516|O2|Outcome|Placebo|In this crossover study, 18 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin followed by a single dose of 40 IU of intranasal placebo and 14 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin, for a total of 32 completed participants.
92248|NCT01829516|O1|Outcome|Oxytocin|In this crossover study, 18 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin followed by a single dose of 40 IU of intranasal placebo and 14 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin, for a total of 32 completed participants.
92249|NCT01829516|O2|Outcome|Placebo|14 moderate to heavy social alcohol users received 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin and 18 received 40 IU of intranasal oxytocin first followed by 40 IU of intranasal placebo, for a total of 32 participants analyzed.
92250|NCT01829516|O1|Outcome|Oxytocin|18 moderate to heavy social alcohol users received 40 IU of intranasal oxytocin followed by 40 IU of intranasal placebo and 14 received 40 IU of intranasal placebo first followed by 40 IU of intranasal oxytocin, for a total of 32 participants analyzed.
92251|NCT01829516|E2|Reported Event|Placebo|"50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo.
NOTE: This is a cross-over design and subjects will participate in both arms.
Placebo"
92252|NCT01829516|E1|Reported Event|Oxytocin|"50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin.
Oxytocin"
92253|NCT01829477|B3|Baseline|Total|Total of all reporting groups
92254|NCT01829477|B2|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92255|NCT01829477|B1|Baseline|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92256|NCT01829477|P2|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92257|NCT01829477|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92258|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92259|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92260|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92261|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92262|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92263|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92264|NCT01829477|E2|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
92268|NCT01829464|B2|Baseline|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92269|NCT01829464|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
92307|NCT01829243|E2|Reported Event|Placebo|Adverse events in this group occurred while subjects were taking Placebo.
92271|NCT01829464|P2|Participant Flow|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92272|NCT01829464|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
92273|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92274|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92275|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
92276|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92277|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92278|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
92279|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92280|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92281|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
92282|NCT01829464|E3|Reported Event|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92283|NCT01829464|E2|Reported Event|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
92284|NCT01829464|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
92285|NCT01829399|B3|Baseline|Total|Total of all reporting groups
92286|NCT01829399|B2|Baseline|Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation.
92287|NCT01829399|B1|Baseline|Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit|On the first visit, subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of saline was injected 15 minutes prior to tourniquet inflation.
92288|NCT01829399|P2|Participant Flow|Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit|Participants received a subcutaneous axillary ring injection with normal saline on the first visit and a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the second visit.
92289|NCT01829399|P1|Participant Flow|Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the first visit and a subcutaneous axillary ring injection with saline on the second visit.
92290|NCT01829399|O2|Outcome|Saline Axillary Ring on 1st Visit (Control Group)|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation.
92291|NCT01829399|O1|Outcome|Bupivacaine Ring 1st Visit|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation.
92292|NCT01829399|O2|Outcome|Saline Axillary Ring on 1st Visit (Control Group)|Participants received a subcutaneous axillary ring injection with normal saline.
92293|NCT01829399|O1|Outcome|Bupivacaine Axillary Ring on 1st Visit|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000.
92294|NCT01829399|E2|Reported Event|Saline Axillary Ring (Control Group)|Participants received a subcutaneous axillary ring injection with normal saline
92295|NCT01829399|E1|Reported Event|Bupivacaine Axillary Ring|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000
92296|NCT01829243|B1|Baseline|Subjects Who Completed the Study|
92297|NCT01829243|P2|Participant Flow|Placebo First, Then Milnacipran|Patients randomized to receive placebo first
92298|NCT01829243|P1|Participant Flow|Milnacipran First, Then Placebo|Patients randomized to receiving milnacipran first.
92299|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
92302|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran
92303|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
92304|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran.
92305|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
92306|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran.
92313|NCT01829230|P1|Participant Flow|Test Lens C|Test lens C from previous study
92316|NCT01829230|O2|Outcome|Test Lens A|Test lens A from the previous study
92317|NCT01829230|O1|Outcome|Test Lens C|Test lens C from the previous study
92318|NCT01829230|E2|Reported Event|Test Lens A|Test lens A from previous study
92319|NCT01829230|E1|Reported Event|Test Lens C|Test lens C from previous study
92320|NCT01829191|B3|Baseline|Total|Total of all reporting groups
92321|NCT01829191|B2|Baseline|Test Lens C|Test lens will be worn in a daily wear modality
92322|NCT01829191|B1|Baseline|Test Lens A|Test lenses will be worn in a daily wear modality
92323|NCT01829191|P2|Participant Flow|Test Lens C|Test lens will be worn in a daily wear modality
92324|NCT01829191|P1|Participant Flow|Test Lens A|Test lenses will be worn in a daily wear modality
92325|NCT01829191|O2|Outcome|Test Lens C|Test lenses will be worn in a daily wear modality
92326|NCT01829191|O1|Outcome|Test Lens A|Test lenses will be worn in a daily wear modality
92327|NCT01829191|O2|Outcome|Test Lens C|Test lenses will be worn in a daily wear modality
92328|NCT01829191|O1|Outcome|Test Lens A|Test lenses will be worn in a daily wear modality
92329|NCT01829191|E1|Reported Event|All Subjects|All subjects who eligible to participate in the study whether or not randomized to the study arm.
92330|NCT01828593|B4|Baseline|Total|Total of all reporting groups
92331|NCT01828593|B3|Baseline|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92332|NCT01828593|B2|Baseline|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92333|NCT01828593|B1|Baseline|Placebo|Matching Placebo
92334|NCT01828593|P3|Participant Flow|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92335|NCT01828593|P2|Participant Flow|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92336|NCT01828593|P1|Participant Flow|Placebo|"Matching Placebo
Following 4 weeks in placebo-controlled phase were randomized to either SBI 2.5 g or SBI 5.0 g"
92337|NCT01828593|O2|Outcome|CD8 + T Cell Counts|
92338|NCT01828593|O1|Outcome|CD4 + T Cell Counts|
92339|NCT01828593|O3|Outcome|SBI 5.0 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 5.0 grams
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92340|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 grams
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92341|NCT01828593|O1|Outcome|Placebo|Matching Placebo
92381|NCT01828281|B1|Baseline|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
92382|NCT01828281|P2|Participant Flow|Control|subtherapeutic CPAP using 4 cm water
92342|NCT01828593|O3|Outcome|SBI 5.0 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 5.0 grams
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92343|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 grams
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92344|NCT01828593|O1|Outcome|Placebo|Matching Placebo
92388|NCT01828281|O2|Outcome|Control|"subtherapeutic CPAP using 4 cm water
CPAP: All subjects will undergo ultrasound examination of the abdomen the day after overnight PSG and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water."
92414|NCT01828112|B2|Baseline|Chemotherapy|Chemotherapy as determined by BIRC.
92345|NCT01828593|O3|Outcome|SBI 5.0 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 5.0 grams
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92346|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 grams
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92347|NCT01828593|O1|Outcome|Placebo|Matching Placebo
92348|NCT01828593|O3|Outcome|SBI 5.0 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 5.0 grams
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92349|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 grams
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92350|NCT01828593|O1|Outcome|Placebo|Matching Placebo
92351|NCT01828593|O3|Outcome|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92352|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92353|NCT01828593|O1|Outcome|Placebo|Matching Placebo
92354|NCT01828593|E2|Reported Event|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g - Subjects on 5.0 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 5.0 g in the placebo free phase
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92355|NCT01828593|E1|Reported Event|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g - Subjects on 2.5 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 2.5 g in the placebo free phase
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
92356|NCT01828476|B3|Baseline|Total|Total of all reporting groups
92357|NCT01828476|B2|Baseline|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily
* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
92383|NCT01828281|P1|Participant Flow|Therapeutic CPAP|The continuous positive airway pressure (CPAP) level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
92384|NCT01828281|O2|Outcome|Control|subtherapeutic CPAP using 4 cm water
93465|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
92358|NCT01828476|B1|Baseline|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*
* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.
NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
92389|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
92359|NCT01828476|P2|Participant Flow|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily
* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
92360|NCT01828476|P1|Participant Flow|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*
* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.
NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
92361|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B
Hydroxychloroquine: ARM B"
92362|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B"
92363|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B
Hydroxychloroquine: ARM B"
92364|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B"
92365|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B
Hydroxychloroquine: ARM B"
92366|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B"
92367|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B
Hydroxychloroquine: ARM B"
92368|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B"
92369|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B
Hydroxychloroquine: ARM B"
92370|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B"
92371|NCT01828476|O2|Outcome|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily
* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
92372|NCT01828476|O1|Outcome|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*
* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.
NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
92373|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B
Hydroxychloroquine: ARM B"
92374|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B"
92375|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B
Hydroxychloroquine: ARM B"
92376|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263
Abiraterone: ARM A and ARM B
ABT-263: ARM A and ARM B"
92377|NCT01828476|E2|Reported Event|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily
* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
92378|NCT01828476|E1|Reported Event|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*
* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.
NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
92385|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
92386|NCT01828281|O2|Outcome|Control|subtherapeutic CPAP using 4 cm water
92387|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
92390|NCT01828281|E2|Reported Event|Control|subtherapeutic CPAP using 4 cm water
92415|NCT01828112|B1|Baseline|Ceritinib|Ceritinib 750 mg
92391|NCT01828281|E1|Reported Event|Therapeutic CPAP|The CPAP level for each patient in the therapeutic CPAP arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
92392|NCT01828216|B3|Baseline|Total|Total of all reporting groups
92393|NCT01828216|B2|Baseline|Ambulatory Sleep Study|home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
92394|NCT01828216|B1|Baseline|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
92395|NCT01828216|P2|Participant Flow|Ambulatory Sleep Study|The home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
92396|NCT01828216|P1|Participant Flow|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
92397|NCT01828216|O2|Outcome|Ambulatory Sleep Study|Home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
92398|NCT01828216|O1|Outcome|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
92399|NCT01828216|O2|Outcome|Ambulatory CPAP Titration|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.
92400|NCT01828216|O1|Outcome|In-hospital CPAP Titration|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.
92401|NCT01828216|E2|Reported Event|Ambulatory Sleep Study|home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
92402|NCT01828216|E1|Reported Event|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
92403|NCT01828164|B1|Baseline|All Study Participants|As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
92404|NCT01828164|P1|Participant Flow|All Study Participants|As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
92405|NCT01828164|O2|Outcome|Control Arm|The side of the mouth that was the control. As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
92406|NCT01828164|O1|Outcome|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
92407|NCT01828164|O2|Outcome|Control Arm|The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
92408|NCT01828164|O1|Outcome|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
92409|NCT01828164|O2|Outcome|Control Arm|The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
92410|NCT01828164|O1|Outcome|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
92411|NCT01828164|E2|Reported Event|Control Arm|The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
92412|NCT01828164|E1|Reported Event|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
92416|NCT01828112|P2|Participant Flow|Chemotherapy|Chemotherapy as determined by BIRC.
92417|NCT01828112|P1|Participant Flow|Ceritinib|Ceritinib 750 mg
92418|NCT01828112|O2|Outcome|Chemotherapy|Chemotherapy as determined by BIRC.
92419|NCT01828112|O1|Outcome|Ceritinib|Ceritinib 750 mg
92420|NCT01828112|E2|Reported Event|Chemotherapy|Chemotherapy as determined by BIRC.
92421|NCT01828112|E1|Reported Event|Ceritinib|Ceritinib 750 mg
92422|NCT01827839|B1|Baseline|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92423|NCT01827839|P1|Participant Flow|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92424|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92425|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92426|NCT01827839|O3|Outcome|GSK1437173A Group >=70 YOA|Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
92427|NCT01827839|O2|Outcome|GSK1437173A Group 60-69 YOA|Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
92428|NCT01827839|O1|Outcome|GSK1437173A Group 50-59 YOA|Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
92429|NCT01827839|O3|Outcome|GSK1437173A Group >=70 YOA|Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
92430|NCT01827839|O2|Outcome|GSK1437173A Group 60-69 YOA|Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
92431|NCT01827839|O1|Outcome|GSK1437173A Group 50-59 YOA|Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
92432|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92433|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92434|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92435|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92436|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92437|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92438|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92439|NCT01827839|O4|Outcome|GSK1437173A Group >=70 YOA|Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
92440|NCT01827839|O3|Outcome|GSK1437173A Group 60-69 YOA|Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
92441|NCT01827839|O2|Outcome|GSK1437173A Group 50-59 YOA|Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
92442|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
92443|NCT01827839|E1|Reported Event|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
92444|NCT01827670|B3|Baseline|Total|Total of all reporting groups
92445|NCT01827670|B2|Baseline|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
92446|NCT01827670|B1|Baseline|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
92447|NCT01827670|P2|Participant Flow|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
92469|NCT01827592|P1|Participant Flow|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.
93474|NCT01822301|O2|Outcome|CT Imaging at 3 Months PO|CT imaging at 3 months post-operation
92448|NCT01827670|P1|Participant Flow|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds .
92449|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
92450|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
92451|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
92452|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
92453|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride Dentifrice)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
92454|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 mililiter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds
92455|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
92456|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
92457|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
92458|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
92459|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
92460|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
92461|NCT01827670|E2|Reported Event|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
92824|NCT01826812|E1|Reported Event|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
92462|NCT01827670|E1|Reported Event|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds
92463|NCT01827592|B4|Baseline|Total|Total of all reporting groups
92464|NCT01827592|B3|Baseline|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
92465|NCT01827592|B2|Baseline|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92466|NCT01827592|B1|Baseline|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92467|NCT01827592|P3|Participant Flow|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
92468|NCT01827592|P2|Participant Flow|EBX 5|Elobixibat 5 mg/day as administered orally in a tablet form starting from Baseline visit till EoT visit.
92470|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
92471|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92472|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92473|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
92474|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92475|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92476|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
92477|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92478|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92479|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
92480|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92481|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92482|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
92483|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92484|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92485|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
92486|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92487|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92488|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
92489|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92490|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92491|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
92492|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92493|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92494|NCT01827592|E3|Reported Event|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
92495|NCT01827592|E2|Reported Event|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92496|NCT01827592|E1|Reported Event|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
92497|NCT01827475|B4|Baseline|Total|Total of all reporting groups
92498|NCT01827475|B3|Baseline|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
92499|NCT01827475|B2|Baseline|Acetaminophen|Acetaminophen 1 gm
92500|NCT01827475|B1|Baseline|Ibuprofen|Ibuprofen 800 mg
92501|NCT01827475|P3|Participant Flow|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
92502|NCT01827475|P2|Participant Flow|Acetaminophen|Acetaminophen 1 gm
92503|NCT01827475|P1|Participant Flow|Ibuprofen|Ibuprofen 800 mg
92504|NCT01827475|O3|Outcome|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
92505|NCT01827475|O2|Outcome|Acetaminophen|Acetaminophen 1 gm
92506|NCT01827475|O1|Outcome|Ibuprofen|Ibuprofen 800 mg
92507|NCT01827475|O3|Outcome|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
92508|NCT01827475|O2|Outcome|Acetaminophen|Acetaminophen 1 gm
92509|NCT01827475|O1|Outcome|Ibuprofen|Ibuprofen 800 mg
92510|NCT01827475|E3|Reported Event|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
92511|NCT01827475|E2|Reported Event|Acetaminophen|Acetaminophen 1 gm
92512|NCT01827475|E1|Reported Event|Ibuprofen|Ibuprofen 800 mg
92513|NCT01827462|B4|Baseline|Total|Total of all reporting groups
92514|NCT01827462|B3|Baseline|80-100 Years Old at Enrollment|"Participants receive the licensed annual vaccine, Fluzone® or High Dose Fluzone®
This vaccine is given intramuscularly"
92515|NCT01827462|B2|Baseline|60-79 Years Old at Enrollment|"Participants receive the licensed annual vaccine, Fluzone®
This vaccine is given intramuscularly"
92516|NCT01827462|B1|Baseline|18-30 Years Old at Enrollment|"Participants receive the licensed annual, Fluzone®
This vaccine is given intramuscularly"
92517|NCT01827462|P3|Participant Flow|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®
This vaccine is given intramuscularly"
92518|NCT01827462|P2|Participant Flow|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®
This vaccine is given intramuscularly"
92519|NCT01827462|P1|Participant Flow|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®
This vaccine is given intramuscularly"
92520|NCT01827462|O3|Outcome|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season. For the following seasons, they received Fluzone High-Dose.
This vaccine is given intramuscularly"
92521|NCT01827462|O2|Outcome|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season. For the following seasons, they received Fluzone High-Dose.
This vaccine is given intramuscularly"
92522|NCT01827462|O1|Outcome|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through 2013-2014 then received licensed annual quadrivalent Fluzone.
This vaccine is given intramuscularly"
92523|NCT01827462|O3|Outcome|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®
This vaccine is given intramuscularly"
92524|NCT01827462|O2|Outcome|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®
This vaccine is given intramuscularly"
92525|NCT01827462|O1|Outcome|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®
This vaccine is given intramuscularly"
92526|NCT01827462|E3|Reported Event|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season.
This vaccine is given intramuscularly"
92527|NCT01827462|E2|Reported Event|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season.
This vaccine is given intramuscularly"
92528|NCT01827462|E1|Reported Event|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed quadrivalent vaccine, Fluzone starting with the 2014-2015 season.
This vaccine is given intramuscularly"
92529|NCT01827371|B5|Baseline|Total|Total of all reporting groups
92530|NCT01827371|B4|Baseline|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
92531|NCT01827371|B3|Baseline|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
92532|NCT01827371|B2|Baseline|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
92533|NCT01827371|B1|Baseline|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
92534|NCT01827371|P4|Participant Flow|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
92535|NCT01827371|P3|Participant Flow|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
92536|NCT01827371|P2|Participant Flow|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
92537|NCT01827371|P1|Participant Flow|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
92538|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
92539|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
92540|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
92541|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
92542|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
92543|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
92544|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
92545|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
92546|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
92547|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
92548|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
92549|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
92550|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
92551|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
92552|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
92825|NCT01826604|B3|Baseline|Total|Total of all reporting groups
92553|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
92554|NCT01827371|E4|Reported Event|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
92555|NCT01827371|E3|Reported Event|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
92556|NCT01827371|E2|Reported Event|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
92557|NCT01827371|E1|Reported Event|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
92558|NCT01827358|B3|Baseline|Total|Total of all reporting groups
92559|NCT01827358|B2|Baseline|No Mupirocin (Control)|Participants received no treatment or placebo
92560|NCT01827358|B1|Baseline|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
92561|NCT01827358|P2|Participant Flow|No Mupirocin (Control)|Participants received no treatment or placebo
92562|NCT01827358|P1|Participant Flow|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
92563|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92564|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92565|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92566|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92567|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92568|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92569|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92570|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92571|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92572|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92573|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92574|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92575|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92576|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92577|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92578|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92579|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92580|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92581|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92582|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92583|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92584|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92585|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92586|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92587|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92677|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92588|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92589|NCT01827358|O2|Outcome|No Mupirocin (Control)|Participants received no treatment and no placebo.
92590|NCT01827358|O1|Outcome|Mupirocin (Treatment)|Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
92591|NCT01827358|E2|Reported Event|No Mupirocin (Control)|Participants received no treatment and no placebo.
92592|NCT01827358|E1|Reported Event|Mupirocin (Treatment)|Participants receive a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
92593|NCT01827332|B3|Baseline|Total|Total of all reporting groups
93377|NCT01822756|E4|Reported Event|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
92594|NCT01827332|B2|Baseline|Saline|"intranasal administration
Saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET."
92595|NCT01827332|B1|Baseline|Oxytocin|"intranasal administration
Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET."
92596|NCT01827332|P2|Participant Flow|Saline|"intranasal administration
Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
92597|NCT01827332|P1|Participant Flow|Oxytocin|"intranasal administration
Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
92598|NCT01827332|O2|Outcome|Saline|"intranasal administration
Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
92599|NCT01827332|O1|Outcome|Oxytocin|"intranasal administration
Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
92600|NCT01827332|O2|Outcome|Saline|"intranasal administration
Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
92601|NCT01827332|O1|Outcome|Oxytocin|"intranasal administration
Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
92602|NCT01827332|E2|Reported Event|Saline|"intranasal administration
Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
92603|NCT01827332|E1|Reported Event|Oxytocin|"intranasal administration
Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
92604|NCT01827319|B1|Baseline|Received TMR and Enrolled in ANGINA RELIEF Registry|
92605|NCT01827319|P1|Participant Flow|Received TMR and Enrolled in ANGINA RELIEF Registry|
92606|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
92607|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
92608|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
92609|NCT01827319|E1|Reported Event|Received TMR and Enrolled in ANGINA RELIEF Registry|
92610|NCT01827306|B3|Baseline|Total|Total of all reporting groups
92611|NCT01827306|B2|Baseline|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
92612|NCT01827306|B1|Baseline|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.
Biofreeze"
92613|NCT01827306|P2|Participant Flow|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
92614|NCT01827306|P1|Participant Flow|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.
Biofreeze"
92615|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
92616|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.
Biofreeze"
92617|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
92618|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.
Biofreeze"
92619|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
92620|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.
Biofreeze"
92621|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
92622|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.
Biofreeze"
92623|NCT01827306|E2|Reported Event|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
92624|NCT01827306|E1|Reported Event|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.
Biofreeze"
92625|NCT01827254|B1|Baseline|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
92649|NCT01826981|B2|Baseline|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92626|NCT01827254|P1|Participant Flow|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
92627|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib, followed by third line treatment with bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib, temsirolimus or everolimus as per standard local practice.
92628|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib, followed by second line treatment with bevacizumab (with interferon),bevacizumab (without interferon), sorafenib, axitinib, temsirolimus or everolimus as per standard local practice.
93475|NCT01822301|O1|Outcome|CT Imaging at 7-21 Days PO|CT imaging at 7-21 days post-operation
92629|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­interventional study.
92630|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­-interventional study.
92631|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­-interventional study.
92632|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-­interventional study.
92633|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
92634|NCT01827254|E1|Reported Event|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
92635|NCT01826981|B16|Baseline|Total|Total of all reporting groups
92636|NCT01826981|B15|Baseline|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92637|NCT01826981|B14|Baseline|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92638|NCT01826981|B13|Baseline|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92639|NCT01826981|B12|Baseline|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92640|NCT01826981|B11|Baseline|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92641|NCT01826981|B10|Baseline|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92642|NCT01826981|B9|Baseline|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
92643|NCT01826981|B8|Baseline|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92644|NCT01826981|B7|Baseline|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92645|NCT01826981|B6|Baseline|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92646|NCT01826981|B5|Baseline|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92647|NCT01826981|B4|Baseline|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92648|NCT01826981|B3|Baseline|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92826|NCT01826604|B2|Baseline|Control|Other retractor used during C-section
92650|NCT01826981|B1|Baseline|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92651|NCT01826981|P15|Participant Flow|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92652|NCT01826981|P14|Participant Flow|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92653|NCT01826981|P13|Participant Flow|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92654|NCT01826981|P12|Participant Flow|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92655|NCT01826981|P11|Participant Flow|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92656|NCT01826981|P10|Participant Flow|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|Sofosbuvir (SOF) 400 mg once daily+Velpatasvir (VEL) 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92657|NCT01826981|P9|Participant Flow|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and Child Pugh-Turcotte (CPT) B cirrhosis
92658|NCT01826981|P8|Participant Flow|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92659|NCT01826981|P7|Participant Flow|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92660|NCT01826981|P6|Participant Flow|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92661|NCT01826981|P5|Participant Flow|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92662|NCT01826981|P4|Participant Flow|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92663|NCT01826981|P3|Participant Flow|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92664|NCT01826981|P2|Participant Flow|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92665|NCT01826981|P1|Participant Flow|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92666|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92667|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92668|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92669|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92670|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92671|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92672|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
92673|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92674|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92675|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92676|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92706|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92678|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92679|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92680|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92864|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92681|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92682|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92683|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92684|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92685|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92686|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92687|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
92688|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92689|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92690|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92691|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92692|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92693|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92694|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92695|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92696|NCT01826981|O1|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92697|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92698|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92699|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92700|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92701|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92702|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92703|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
92704|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92705|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92707|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92708|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92709|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92865|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
92710|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92711|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92712|NCT01826981|O1|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92713|NCT01826981|O11|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92714|NCT01826981|O10|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92715|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
92716|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92717|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92718|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92719|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92720|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92721|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92722|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92723|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92724|NCT01826981|O11|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92725|NCT01826981|O10|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92726|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
92727|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92728|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92729|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92730|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92731|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92732|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92733|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92734|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92735|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92736|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92737|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92738|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92739|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92740|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92741|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
92742|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92743|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92744|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92745|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92746|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92747|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92748|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92749|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92750|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92751|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92752|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92753|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92754|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92755|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92756|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
92757|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92758|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92759|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92760|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92761|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92822|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
92762|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92763|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92866|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92764|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92765|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92766|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92767|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92768|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92769|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92770|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92771|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
92772|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92773|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92774|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92775|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92776|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92777|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92778|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92779|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92780|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92781|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92782|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92783|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92784|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92785|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92786|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
92787|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92788|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92823|NCT01826812|E2|Reported Event|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
92789|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92790|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92791|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92792|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92793|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92794|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92795|NCT01826981|E15|Reported Event|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92796|NCT01826981|E14|Reported Event|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92797|NCT01826981|E13|Reported Event|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92798|NCT01826981|E12|Reported Event|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
92799|NCT01826981|E11|Reported Event|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
92800|NCT01826981|E10|Reported Event|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92801|NCT01826981|E9|Reported Event|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
92802|NCT01826981|E8|Reported Event|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
92803|NCT01826981|E7|Reported Event|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
92804|NCT01826981|E6|Reported Event|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
92805|NCT01826981|E5|Reported Event|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
92806|NCT01826981|E4|Reported Event|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92807|NCT01826981|E3|Reported Event|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
92808|NCT01826981|E2|Reported Event|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
92809|NCT01826981|E1|Reported Event|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
92810|NCT01826812|B3|Baseline|Total|Total of all reporting groups
92811|NCT01826812|B2|Baseline|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
92812|NCT01826812|B1|Baseline|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
92813|NCT01826812|P2|Participant Flow|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
92814|NCT01826812|P1|Participant Flow|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
92815|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
92816|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
92817|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
92818|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
92819|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
92820|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
92821|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
92828|NCT01826604|P2|Participant Flow|Control|"Conventional hand-held surgical retractors used for C-sections will be used, including the bladder blade (Doyen retractor) and the Richardson retractor.
Control- Conventional hand-held retractors: Conventional hand-held retractors will be used. A self-retaining barrier retractor will not be used."
92829|NCT01826604|P1|Participant Flow|Alexis O C-section Retractor|"The Alexis O C-section retractor will be used. Other hand-held retractors will be used as deemed necessary by the surgeon.
Alexis O C-Section Retractor: The Alexis O C-section retractor will be used. Other hand-held retractors that are deemed necessary to the surgery by the physician will also be used."
93714|NCT01820559|O2|Outcome|ESL 800 mg|"eslicarbazepine acetate 800 mg
ESL 800 mg :"
92830|NCT01826604|O2|Outcome|Control|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
92831|NCT01826604|O1|Outcome|Alexis Retractor|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
92832|NCT01826604|O2|Outcome|Control|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
92833|NCT01826604|O1|Outcome|Alexis Retractor|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
92834|NCT01826604|E2|Reported Event|Control|No adverse events
92835|NCT01826604|E1|Reported Event|Alexis Retractor|No adverse events
92836|NCT01826513|B4|Baseline|Total|Total of all reporting groups
92837|NCT01826513|B3|Baseline|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night
92838|NCT01826513|B2|Baseline|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
92839|NCT01826513|B1|Baseline|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
92840|NCT01826513|P3|Participant Flow|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.
92841|NCT01826513|P2|Participant Flow|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
92842|NCT01826513|P1|Participant Flow|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
92843|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
92844|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92845|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
92846|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92847|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
92848|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92849|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
92850|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92851|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
92852|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92853|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
92854|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92855|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
92856|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92857|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
92858|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92859|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
93466|NCT01822535|O2|Outcome|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
92860|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92861|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
92862|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
92863|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
93715|NCT01820559|O1|Outcome|Placebo|"Placebo tablets
Placebo : Tablets"
92867|NCT01826513|E3|Reported Event|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.
92868|NCT01826513|E2|Reported Event|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
92869|NCT01826513|E1|Reported Event|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
92870|NCT01826370|B1|Baseline|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
92871|NCT01826370|P1|Participant Flow|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
92872|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
92873|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
92874|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
92875|NCT01826370|E1|Reported Event|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
92876|NCT01826214|B3|Baseline|Total|Total of all reporting groups
92877|NCT01826214|B2|Baseline|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92878|NCT01826214|B1|Baseline|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92879|NCT01826214|P2|Participant Flow|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92880|NCT01826214|P1|Participant Flow|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92881|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92882|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92883|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92884|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92885|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92886|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92887|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92888|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92889|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92890|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92891|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92892|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92893|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92894|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92922|NCT01825577|E1|Reported Event|Single Arm Transdermal Methylphenidate|There were no adverse events reported.
92895|NCT01826214|E2|Reported Event|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92896|NCT01826214|E1|Reported Event|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
92897|NCT01826201|B1|Baseline|10% MOL4239 Ointment & Placebo Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
92898|NCT01826201|P1|Participant Flow|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
92899|NCT01826201|O1|Outcome|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
92900|NCT01826201|O2|Outcome|Placebo Ointment|10% MOL4239 to one target lesion and placebo to contralateral target lesion
92901|NCT01826201|O1|Outcome|10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
92902|NCT01826201|E1|Reported Event|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
92903|NCT01825837|B5|Baseline|Total|Total of all reporting groups
92904|NCT01825837|B4|Baseline|ESL (Part I - Not Randomised Patients)|This group corresponds to the 17 patients who did not complete part I and therefore where not randomised to any traeatment group.
92905|NCT01825837|B3|Baseline|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
92906|NCT01825837|B2|Baseline|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
92907|NCT01825837|B1|Baseline|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
92908|NCT01825837|P4|Participant Flow|ESL (Part I)|In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. The participants that completed part I were randomised in Part II.
92909|NCT01825837|P3|Participant Flow|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
92910|NCT01825837|P2|Participant Flow|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
92911|NCT01825837|P1|Participant Flow|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
92912|NCT01825837|O3|Outcome|BIA 2-093 1800 mg|PART II - Intent-to-Treat Population
92913|NCT01825837|O2|Outcome|BIA 2-093 900 mg|PART II - Intent-to-Treat Population
92914|NCT01825837|O1|Outcome|BIA 2-093 300 mg|PART II - Intent-to-Treat Population
92915|NCT01825837|E3|Reported Event|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
92916|NCT01825837|E2|Reported Event|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
92917|NCT01825837|E1|Reported Event|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
92918|NCT01825577|B1|Baseline|Single Arm|"Age 65yrs and above
Ability to ambulate (may use walking aid)
Male or Female
Clinical diagnosis of probable Alzheimer's Disease
AES score >40
Identified as fall risk by nursing staff"
92919|NCT01825577|P1|Participant Flow|Single Arm Transdermal Methylphenidate|"Age 65 yrs and above
Ability to ambulate (may use walking aid)
Male or Female
Clinical diagnosis of probable Alzheimer's Disease
AES score >40
Identified as fall risk by nursing staff"
92981|NCT01823679|P1|Participant Flow|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
92920|NCT01825577|O1|Outcome|Transdermal Methylphenidate|"2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day.
Transdermal Methylphenidate: 2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day."
92921|NCT01825577|O1|Outcome|Transdermal Methylphenidate|"2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day.
Transdermal Methylphenidate: 2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day."
92923|NCT01825408|B5|Baseline|Total|Total of all reporting groups
92924|NCT01825408|B4|Baseline|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.
Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92925|NCT01825408|B3|Baseline|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.
Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92926|NCT01825408|B2|Baseline|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92927|NCT01825408|B1|Baseline|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92928|NCT01825408|P4|Participant Flow|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.
Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92929|NCT01825408|P3|Participant Flow|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.
Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92930|NCT01825408|P2|Participant Flow|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92931|NCT01825408|P1|Participant Flow|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92932|NCT01825408|O2|Outcome|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.
Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92947|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
93467|NCT01822535|O1|Outcome|Tetraplegia|Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
92933|NCT01825408|O1|Outcome|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92984|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given orally (PO)"
92934|NCT01825408|O2|Outcome|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.
Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92935|NCT01825408|O1|Outcome|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92936|NCT01825408|E4|Reported Event|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.
Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92937|NCT01825408|E3|Reported Event|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.
Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92938|NCT01825408|E2|Reported Event|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92939|NCT01825408|E1|Reported Event|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.
Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
92940|NCT01825200|B3|Baseline|Total|Total of all reporting groups
92941|NCT01825200|B2|Baseline|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
92942|NCT01825200|B1|Baseline|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
92943|NCT01825200|P2|Participant Flow|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
92944|NCT01825200|P1|Participant Flow|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
92945|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
92946|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
93024|NCT01823614|E3|Reported Event|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
92948|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
92985|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given orally (PO)"
92949|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
92950|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
92951|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
92952|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
92953|NCT01825200|E2|Reported Event|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
92954|NCT01825200|E1|Reported Event|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
92955|NCT01825122|B3|Baseline|Total|Total of all reporting groups
92956|NCT01825122|B2|Baseline|Active, Nadolol|"Active
Nadolol"
92957|NCT01825122|B1|Baseline|Placebo|"placebo
Placebo"
92958|NCT01825122|P2|Participant Flow|Active, Nadolol|"Active
Nadolol"
92959|NCT01825122|P1|Participant Flow|Placebo|"placebo
Placebo"
92960|NCT01825122|O2|Outcome|Active, Nadolol|"Active
Nadolol"
92961|NCT01825122|O1|Outcome|Placebo|"placebo
Placebo"
92962|NCT01825122|E2|Reported Event|Active, Nadolol|"Active
Nadolol"
92963|NCT01825122|E1|Reported Event|Placebo|"placebo
Placebo"
92964|NCT01824901|B1|Baseline|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
92965|NCT01824901|P4|Participant Flow|Phase II Step II|"Patients receive FGFR inhibitor AZD4547 PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
AZD4547: Given PO"
92966|NCT01824901|P3|Participant Flow|Arm II (Docetaxel and AZD4547; Phase II Step I)|"Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
AZD4547: Given PO"
92967|NCT01824901|P2|Participant Flow|Arm I (Docetaxel; Phase II Step I)|"Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who experience progressive disease may then register to step II treatment and receive FGFR inhibitor AZD4547 PO BID on days 1-14.
docetaxel: Given IV"
92968|NCT01824901|P1|Participant Flow|Phase I|"Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
AZD4547: Given PO"
92969|NCT01824901|O1|Outcome|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
92970|NCT01824901|E1|Reported Event|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
92971|NCT01824823|B3|Baseline|Total|Total of all reporting groups
92972|NCT01824823|B2|Baseline|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
92973|NCT01824823|B1|Baseline|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
92974|NCT01824823|P2|Participant Flow|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
92975|NCT01824823|P1|Participant Flow|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
92976|NCT01824823|O2|Outcome|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
92977|NCT01824823|O1|Outcome|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
92978|NCT01824823|E2|Reported Event|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
92979|NCT01824823|E1|Reported Event|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
92980|NCT01823679|B1|Baseline|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
92982|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given orally (PO)"
92983|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given orally (PO)"
93378|NCT01822756|E3|Reported Event|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
92986|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m²|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given orally (PO)"
92987|NCT01823679|E1|Reported Event|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
92988|NCT01823653|B1|Baseline|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
92989|NCT01823653|P1|Participant Flow|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
92990|NCT01823653|O1|Outcome|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
92991|NCT01823653|O1|Outcome|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
92992|NCT01823653|O1|Outcome|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
92993|NCT01823653|O2|Outcome|Control Thigh|Each subject's own thigh untreated during study
92994|NCT01823653|O1|Outcome|Treated Thigh|Randomly assigned left or right thigh that received treatment with Liposonix System (Model 2)
92995|NCT01823653|E1|Reported Event|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
92996|NCT01823614|B7|Baseline|Total|Total of all reporting groups
92997|NCT01823614|B6|Baseline|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
92998|NCT01823614|B5|Baseline|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
92999|NCT01823614|B4|Baseline|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
93000|NCT01823614|B3|Baseline|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
93001|NCT01823614|B2|Baseline|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
93002|NCT01823614|B1|Baseline|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
93003|NCT01823614|P6|Participant Flow|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
93004|NCT01823614|P5|Participant Flow|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
93005|NCT01823614|P4|Participant Flow|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
93006|NCT01823614|P3|Participant Flow|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
93007|NCT01823614|P2|Participant Flow|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
93008|NCT01823614|P1|Participant Flow|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
93009|NCT01823614|O3|Outcome|CD4 Cell Count < 350|Group which contains naive patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
93010|NCT01823614|O2|Outcome|CD4 Cell Count 350-500|Group which contains naive patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
93011|NCT01823614|O1|Outcome|CD4 Cell Count > 500|Group which contains naive patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
93012|NCT01823614|O3|Outcome|CD4 Cell Count < 350|Group which contains patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
93013|NCT01823614|O2|Outcome|CD4 Cell Count 350-500|Group which contains patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
93014|NCT01823614|O1|Outcome|CD4 Cell Count > 500|Group which contains patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
93015|NCT01823614|O6|Outcome|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
93016|NCT01823614|O5|Outcome|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
93017|NCT01823614|O4|Outcome|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
93018|NCT01823614|O3|Outcome|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
93019|NCT01823614|O2|Outcome|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
93020|NCT01823614|O1|Outcome|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
93021|NCT01823614|E6|Reported Event|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
93022|NCT01823614|E5|Reported Event|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
93023|NCT01823614|E4|Reported Event|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
93025|NCT01823614|E2|Reported Event|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
93026|NCT01823614|E1|Reported Event|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
93027|NCT01824602|B5|Baseline|Total|Total of all reporting groups
93028|NCT01824602|B4|Baseline|Group 1: Eslicarbazepine Acetate 1800 mg|"Eslicarbazepine acetate 1800 mg
Eslicarbazepine acetate 1800 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
93716|NCT01820559|E3|Reported Event|ESL 1200 mg|"eslicarbazepine acetate 1200 mg
ESL 1200 mg :"
93029|NCT01824602|B3|Baseline|Group 2: Eslicarbazepine Acetate 1200 mg|"Eslicarbazepine acetate 1200 mg
Eslicarbazepine acetate 1200 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
93030|NCT01824602|B2|Baseline|Group 3: Eslicarbazepine Acetate 600 mg|"Eslicarbazepine acetate 600 mg
Eslicarbazepine acetate 600 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
93031|NCT01824602|B1|Baseline|Group 4: Placebo|"Placebo pills
Placebo : Placebo sugar pills"
93032|NCT01824602|P4|Participant Flow|Group 1: Eslicarbazepine Acetate 1800 mg|"Eslicarbazepine acetate 1800 mg
Eslicarbazepine acetate 1800 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
93033|NCT01824602|P3|Participant Flow|Group 2: Eslicarbazepine Acetate 1200 mg|"Eslicarbazepine acetate 1200 mg
Eslicarbazepine acetate 1200 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
93034|NCT01824602|P2|Participant Flow|Group 3: Eslicarbazepine Acetate 600 mg|"Eslicarbazepine acetate 600 mg
Eslicarbazepine acetate 600 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
93035|NCT01824602|P1|Participant Flow|Group 4: Placebo|"Placebo pills
Placebo : Placebo sugar pills"
93036|NCT01824602|O4|Outcome|ESL 1800 mg|(ITT Population
93037|NCT01824602|O3|Outcome|ESL 1200 mg|ITT Population
93038|NCT01824602|O2|Outcome|ESL 600 mg|ITT Population
93039|NCT01824602|O1|Outcome|Placebo|ITT Population
93040|NCT01824602|E4|Reported Event|ESL 1800 mg|Safety Population
93041|NCT01824602|E3|Reported Event|ESL 1200 mg|Safety Population
93042|NCT01824602|E2|Reported Event|ESL 600 mg|Safety Population
93043|NCT01824602|E1|Reported Event|Placebo|Safety Population
93044|NCT01824589|B5|Baseline|Total|Total of all reporting groups
93045|NCT01824589|B4|Baseline|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93046|NCT01824589|B3|Baseline|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93047|NCT01824589|B2|Baseline|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93048|NCT01824589|B1|Baseline|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93049|NCT01824589|P4|Participant Flow|Group D|"no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg.
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93050|NCT01824589|P3|Participant Flow|Group C|"no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg.
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93051|NCT01824589|P2|Participant Flow|Group B|"no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg.
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93052|NCT01824589|P1|Participant Flow|Group A|"no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg.
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93053|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93140|NCT01824303|B2|Baseline|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
93410|NCT01822665|O2|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
93054|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93055|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93056|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93057|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93058|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93059|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93060|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93061|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93062|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93063|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93064|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93065|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93066|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93067|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93068|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93069|NCT01824589|E4|Reported Event|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93138|NCT01824342|E1|Reported Event|Placebo/ Denosumab 120 mg Q4W|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93070|NCT01824589|E3|Reported Event|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
93071|NCT01824589|E2|Reported Event|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93072|NCT01824589|E1|Reported Event|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
93073|NCT01824498|B7|Baseline|Total|Total of all reporting groups
93074|NCT01824498|B6|Baseline|Low Fat High Omega 3, Low Fat, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93075|NCT01824498|B5|Baseline|Low Fat High Omega 3, High Fat, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93076|NCT01824498|B4|Baseline|High Fat, Low Fat High Omega 3, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93077|NCT01824498|B3|Baseline|High Fat, Low Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93078|NCT01824498|B2|Baseline|Low Fat, Low Fat High Omega 3, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93079|NCT01824498|B1|Baseline|Low Fat, High Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93080|NCT01824498|P6|Participant Flow|Low Fat High Omega 3, Low Fat, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93081|NCT01824498|P5|Participant Flow|Low Fat High Omega 3, High Fat, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93082|NCT01824498|P4|Participant Flow|High Fat, Low Fat High Omega 3, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93083|NCT01824498|P3|Participant Flow|High Fat, Low Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93084|NCT01824498|P2|Participant Flow|Low Fat, Low Fat High Omega 3, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93085|NCT01824498|P1|Participant Flow|Low Fat, High Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
93086|NCT01824498|O3|Outcome|Low Fat, High n3 Diet|Low fat, n3 diet = 20% fat + 3% n3
93087|NCT01824498|O2|Outcome|Low Fat Diet|Low fat diet = 20% fat
93088|NCT01824498|O1|Outcome|High Fat Diet|Hig fat diet = 40% fat
93089|NCT01824498|E3|Reported Event|Low Fat, High n3 Diet|Low fat, high n3 diet = 20% fat + 3% n3
93090|NCT01824498|E2|Reported Event|Low Fat Diet|Low fat diet = 20% fat
93091|NCT01824498|E1|Reported Event|High Fat Diet|High fat diet = 40% fat
93092|NCT01824446|B1|Baseline|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93093|NCT01824446|P1|Participant Flow|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93094|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93095|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93096|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93097|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93098|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93099|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93100|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93101|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93102|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93103|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93104|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93105|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93106|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93107|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93108|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93109|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93110|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93111|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93112|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93113|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
93114|NCT01824446|E1|Reported Event|[14C]SSP-004184|
93115|NCT01824355|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
93139|NCT01824303|B3|Baseline|Total|Total of all reporting groups
93141|NCT01824303|B1|Baseline|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
93142|NCT01824303|P2|Participant Flow|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
93116|NCT01824355|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:
At least 60% of subjects were younger than 65 years of age.
At least 20% had type 1 diabetes.
At least 50% with type 2 diabetes were insulin users.
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
93117|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
93118|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
93119|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
93120|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
93121|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
93122|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
93123|NCT01824355|E1|Reported Event|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:
At least 60% of subjects were younger than 65 years of age.
At least 20% had type 1 diabetes.
At least 50% with type 2 diabetes were insulin users.
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
93124|NCT01824342|B3|Baseline|Total|Total of all reporting groups
93125|NCT01824342|B2|Baseline|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93126|NCT01824342|B1|Baseline|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93127|NCT01824342|P2|Participant Flow|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93128|NCT01824342|P1|Participant Flow|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93129|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93130|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93131|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93132|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93133|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93134|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93135|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93136|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93137|NCT01824342|E2|Reported Event|Denosumab/ Denosumab 120 mg Q4W|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
93143|NCT01824303|P1|Participant Flow|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
93144|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
93145|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
93146|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
93147|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
93148|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
93149|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
93150|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
93151|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
93152|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
93153|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
93154|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
93155|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
93156|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
93157|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
93158|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
93159|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
93160|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
93161|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
93162|NCT01824303|E4|Reported Event|LiRIS Placebo/LiRIS 400 mg _Open Label Extension|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension.
93163|NCT01824303|E3|Reported Event|LiRIS 400 mg_Open Label Extension|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension.
93164|NCT01824303|E2|Reported Event|LiRIS Placebo_Randomized Study|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study.
93165|NCT01824303|E1|Reported Event|LiRIS 400 mg_Randomized Study|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study.
93166|NCT01824160|B1|Baseline|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury
Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
93167|NCT01824160|P1|Participant Flow|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury
Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
93168|NCT01824160|O1|Outcome|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury
Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
93169|NCT01824160|E1|Reported Event|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury
Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
93170|NCT01823536|B7|Baseline|Total|Total of all reporting groups
93171|NCT01823536|B6|Baseline|Not Assigned|Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate “not assigned” group in the FAS and excluded from the PPS. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7–≤10 Years) group in the extension study.
93172|NCT01823536|B5|Baseline|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
93173|NCT01823536|B4|Baseline|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
93174|NCT01823536|B3|Baseline|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
93175|NCT01823536|B2|Baseline|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93176|NCT01823536|B1|Baseline|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93411|NCT01822665|O1|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
93177|NCT01823536|P6|Participant Flow|Not Assigned|"Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate not assigned group in the Full Analysis Set and excluded from the Per Protocol Set. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7–≤10 Years) group in the extension study."
93178|NCT01823536|P5|Participant Flow|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
93179|NCT01823536|P4|Participant Flow|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
93180|NCT01823536|P3|Participant Flow|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
93181|NCT01823536|P2|Participant Flow|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93182|NCT01823536|P1|Participant Flow|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93183|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
93184|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
93185|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
93186|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93187|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93188|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
93189|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
93190|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
93191|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93192|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93193|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
93194|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
93195|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
93196|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93197|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93198|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
93199|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
93200|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
93201|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93202|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93203|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
93204|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
93373|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
93205|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
93206|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93207|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93208|NCT01823536|O3|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
93209|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93210|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93211|NCT01823536|O3|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
93212|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93213|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93214|NCT01823536|E5|Reported Event|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
93215|NCT01823536|E4|Reported Event|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
93216|NCT01823536|E3|Reported Event|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
93217|NCT01823536|E2|Reported Event|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93218|NCT01823536|E1|Reported Event|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
93219|NCT01823341|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
93220|NCT01823341|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
93221|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93222|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93223|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93224|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93225|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93226|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93227|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93228|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93229|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93230|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93231|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93232|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93233|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93234|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93235|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93236|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93237|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93238|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93239|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93240|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93241|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93242|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93243|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93244|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93245|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93246|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93247|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93248|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93249|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93250|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93251|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93252|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93253|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93254|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93255|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93256|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93257|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93258|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93259|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
93260|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
93261|NCT01823341|E1|Reported Event|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
93262|NCT01823289|B1|Baseline|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
93263|NCT01823289|P1|Participant Flow|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
93264|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
93265|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
93266|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
93267|NCT01823289|E1|Reported Event|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
93268|NCT01823224|B3|Baseline|Total|Total of all reporting groups
93269|NCT01823224|B2|Baseline|Group 2|"Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.
2 capsules Oral Tylenol 2000 mg and IV salt water: The participants randomized to receive the '2 capsules Oral Acetaminophenl 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly."
93270|NCT01823224|B1|Baseline|Group 1|"Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg
IV tylenol 1000mg and 2 oral capsule sugar pills: IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group."
93271|NCT01823224|P2|Participant Flow|"Oral Acetaminophen 2 Capsules + IV Salt Water"|"Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.
2 capsules Oral Tylenol 2000 mg and IV salt water: The participants randomized to receive the '2 capsules Oral Acetaminophenl 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly."
93306|NCT01822821|P2|Participant Flow|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93376|NCT01822756|E5|Reported Event|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
93272|NCT01823224|P1|Participant Flow|"IV Acetaminophen 1000mg + 2 Oral Sugar Pills"|"Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg
IV tylenol 1000mg and 2 oral capsule sugar pills: IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group."
93273|NCT01823224|O2|Outcome|Group 2|This group consisted of 22 subjects that received the oral acetaminophen and IV placebo. Of the 22 there was 1 male and 21 female.
93274|NCT01823224|O1|Outcome|Group 1|This group consisted of 28 subjects' data that was analyzed. Of the 28 there were 7 males 21 females.
93275|NCT01823224|O2|Outcome|Group 2|A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times. There were no significant differences between the groups over time, Wilks’ Lambda (P = 0.875). (Table 4 and Figure 1)
93276|NCT01823224|O1|Outcome|Group 1|A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times.
93277|NCT01823224|E2|Reported Event|Group 2|No adverse events
93278|NCT01823224|E1|Reported Event|Group 1|.Found to have gangreouns gallbladder and stayed greater 24 hours; upon investigation found not related to the acetaminophen
93279|NCT01823146|B3|Baseline|Total|Total of all reporting groups
93280|NCT01823146|B2|Baseline|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN)
93281|NCT01823146|B1|Baseline|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
93282|NCT01823146|P2|Participant Flow|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
93283|NCT01823146|P1|Participant Flow|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
93284|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
93285|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
93286|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
93287|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
93288|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
93289|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
93290|NCT01823146|E2|Reported Event|Placebo Spray|"single dose of 24 IU saline, self-administered intranasally (IN)
Placebo spray: single dose of 24 IU saline, self-administered intranasally (IN)"
93291|NCT01823146|E1|Reported Event|Oxytocin Spray|"single dose of 24 IU oxytocin, self-administered intranasally (IN)
Oxytocin spray: single dose of 24 IU oxytocin, self-administered intranasally (IN)"
93292|NCT01822899|B3|Baseline|Total|Total of all reporting groups
93293|NCT01822899|B2|Baseline|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
93294|NCT01822899|B1|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
93295|NCT01822899|P2|Participant Flow|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
93296|NCT01822899|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
93297|NCT01822899|O2|Outcome|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
93298|NCT01822899|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
93299|NCT01822899|O2|Outcome|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
93300|NCT01822899|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
93301|NCT01822899|E2|Reported Event|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
93302|NCT01822899|E1|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
93303|NCT01822821|B3|Baseline|Total|Total of all reporting groups
93304|NCT01822821|B2|Baseline|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93305|NCT01822821|B1|Baseline|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93307|NCT01822821|P1|Participant Flow|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93308|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93309|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93310|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93311|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93312|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93313|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93314|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93315|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93316|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93317|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93318|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93319|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93320|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93321|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93322|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93323|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93324|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93325|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93326|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93371|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
93372|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
93374|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
93375|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
93327|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93328|NCT01822821|E2|Reported Event|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
93329|NCT01822821|E1|Reported Event|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
93330|NCT01822756|B6|Baseline|Total|Total of all reporting groups
93331|NCT01822756|B5|Baseline|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
93332|NCT01822756|B4|Baseline|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
93333|NCT01822756|B3|Baseline|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
93334|NCT01822756|B2|Baseline|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
93335|NCT01822756|B1|Baseline|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
93336|NCT01822756|P5|Participant Flow|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
93337|NCT01822756|P4|Participant Flow|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
93338|NCT01822756|P3|Participant Flow|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
93339|NCT01822756|P2|Participant Flow|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
93340|NCT01822756|P1|Participant Flow|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
93341|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
93342|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
93343|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
93344|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
93345|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
93346|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
93347|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
93348|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
93349|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
93350|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
93351|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
93352|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
93353|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
93354|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
93355|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
93356|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
93357|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
93358|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
93359|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
93360|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
93361|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
93362|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
93363|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
93364|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
93365|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
93366|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
93367|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
93368|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
93369|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
93370|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
93379|NCT01822756|E2|Reported Event|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
93380|NCT01822756|E1|Reported Event|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
93381|NCT01822691|B1|Baseline|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
93382|NCT01822691|P1|Participant Flow|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
93383|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
93384|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
93385|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
93386|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
93387|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
93388|NCT01822691|E1|Reported Event|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
93389|NCT01822678|B4|Baseline|Total|Total of all reporting groups
93390|NCT01822678|B3|Baseline|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).
Placebo : Placebo, sugar pill"
93391|NCT01822678|B2|Baseline|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.
Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
93392|NCT01822678|B1|Baseline|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.
Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
93393|NCT01822678|P3|Participant Flow|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).
Placebo : Placebo, sugar pill"
93394|NCT01822678|P2|Participant Flow|ESL 600 mg|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.
Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
93395|NCT01822678|P1|Participant Flow|ESL 800 mg|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.
Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
93396|NCT01822678|O3|Outcome|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).
Placebo : Placebo, sugar pill"
93397|NCT01822678|O2|Outcome|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.
Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
93398|NCT01822678|O1|Outcome|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.
Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
93399|NCT01822678|E3|Reported Event|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).
Placebo : Placebo, sugar pill"
93400|NCT01822678|E2|Reported Event|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.
Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
93401|NCT01822678|E1|Reported Event|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.
Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
93402|NCT01822665|B1|Baseline|All Randomized Participants|All randomized participants in the study who took at least one treatment dose.
93403|NCT01822665|P1|Participant Flow|Overall Study|This was a randomized, 4-way crossover study. Participants received two fast dissolving paracetamol tablets (500 milligrams [mg]/tablet) four times daily (QID); two liquid-filled gelatin capsules containing ibuprofen (200 mg/capsule), three times daily (TID); two ibuprofen tablets (200 mg/tablet), TID; and, two fast dissolving placebo tablets QID. All the treatments were administered orally with water. There was a washout period of 7 days following every treatment session.
93405|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen tablet (400 mg/tablet), were administered TID, orally with water.
93406|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/capsule), were administered TID, orally with water.
93407|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
93408|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
93409|NCT01822665|O3|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
93412|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
93413|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen tablets (400 mg/tablet), were administered TID, orally with water.
93414|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
93415|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
93416|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
93417|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
93418|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
93419|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
93420|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), was administered TID, orally with water.
93421|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) was administered QID, orally with water.
93422|NCT01822665|E4|Reported Event|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
93423|NCT01822665|E3|Reported Event|Ibuprofen Tablet (400 mg)|Two ibuprofen tablets (400 mg/tablet), were administered TID, orally with water.
93424|NCT01822665|E2|Reported Event|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/capsule), were administered TID, orally with water.
93425|NCT01822665|E1|Reported Event|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
93426|NCT01822574|B4|Baseline|Total|Total of all reporting groups
93427|NCT01822574|B3|Baseline|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
93428|NCT01822574|B2|Baseline|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93429|NCT01822574|B1|Baseline|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93430|NCT01822574|P3|Participant Flow|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
93431|NCT01822574|P2|Participant Flow|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93432|NCT01822574|P1|Participant Flow|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93433|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
93434|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93435|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93436|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
93437|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93472|NCT01822301|P1|Participant Flow|Repeat Facial Fat Grafting|Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time.
93438|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93439|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
93440|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93441|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93442|NCT01822574|E3|Reported Event|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
93443|NCT01822574|E2|Reported Event|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93444|NCT01822574|E1|Reported Event|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
93445|NCT01822548|B3|Baseline|Total|Total of all reporting groups
93446|NCT01822548|B2|Baseline|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
93447|NCT01822548|B1|Baseline|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Vildagliptin: 100 mg daily"
93448|NCT01822548|P2|Participant Flow|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
93449|NCT01822548|P1|Participant Flow|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Vildagliptin: 100 mg daily"
93450|NCT01822548|O2|Outcome|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
93451|NCT01822548|O1|Outcome|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Vildagliptin: 100 mg daily"
93452|NCT01822548|O2|Outcome|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
93453|NCT01822548|O1|Outcome|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Vildagliptin: 100 mg daily"
93454|NCT01822548|E2|Reported Event|Glibenclamide & Metformin|"Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day."
93455|NCT01822548|E1|Reported Event|Vildagliptin & Metformin|"Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Vildagliptin: 100 mg daily"
93456|NCT01822535|B3|Baseline|Total|Total of all reporting groups
93457|NCT01822535|B2|Baseline|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
93458|NCT01822535|B1|Baseline|Tetraplegia|Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
93459|NCT01822535|P2|Participant Flow|Able-bodied (AB)|Age- and gender-matched to individuals with tetraplegia.
93460|NCT01822535|P1|Participant Flow|Tetraplegia|Lesion level C3-T1, American Spinal Injury Association (ASIA) impairment levels A and B, ages 18-68 years
93461|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
93462|NCT01822535|O2|Outcome|Able-bodied (AB)|Age- and gender-matched to individuals with tetraplegia.
93468|NCT01822535|E3|Reported Event|Drug: Tetraplegia|Those individuals with tetraplegia who completed visit 1 of testing (i.e. no drug)
93469|NCT01822535|E2|Reported Event|No Drug: Able-bodied|Age- and gender-matched to individuals with tetraplegia.
93470|NCT01822535|E1|Reported Event|No Drug: Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
93471|NCT01822301|B1|Baseline|Repeat Facial Fat Grafting|Repeat Fat grafting: Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. We treat 5 subjects from protocol (IRB # PRO09060101) with an additional fat graft treatment to assess whether this will increase fat graft retention over time. .
93473|NCT01822301|O3|Outcome|CT Imaging at 9 Months PO|CT imaging at 9 months post-operation
93476|NCT01822301|O4|Outcome|Facial Volume Score at 9 Months PO|facial volume score at 3 months post-operation
93477|NCT01822301|O3|Outcome|Facial Volume Score at 3 Month PO|facial volume score at 3 months post-operation
93478|NCT01822301|O2|Outcome|Facial Volume Score at 7-21 Day PO|facial volume score at 7-21 days post-operation
93479|NCT01822301|O1|Outcome|Facial Volume Score at Baseline|facial volume score at baseline, pre-op
93480|NCT01822301|E1|Reported Event|Repeat Facial Fat Grafting|Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time.
93481|NCT01822223|B3|Baseline|Total|Total of all reporting groups
93482|NCT01822223|B2|Baseline|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.
Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
93483|NCT01822223|B1|Baseline|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
93484|NCT01822223|P2|Participant Flow|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
93485|NCT01822223|P1|Participant Flow|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
93486|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
93487|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
93488|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
93489|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
93490|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
93491|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
93492|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.
Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
93493|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
93509|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93510|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93494|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.
Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
93513|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93619|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
93620|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
93495|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
93496|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.
Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
93497|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
93498|NCT01822223|E2|Reported Event|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.
Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
93499|NCT01822223|E1|Reported Event|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
93500|NCT01822197|B1|Baseline|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)
Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
93501|NCT01822197|P1|Participant Flow|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)
Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
93502|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)
Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
93503|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)
Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
93504|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)
Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
93505|NCT01822197|E1|Reported Event|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)
Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
93506|NCT01822119|B1|Baseline|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93507|NCT01822119|P1|Participant Flow|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93508|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93511|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93512|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93613|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
93514|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93515|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93516|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93517|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93518|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93519|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93520|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93521|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93522|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93523|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93524|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93525|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93526|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93527|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93528|NCT01822119|E1|Reported Event|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
One implant magnet
One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System"
93529|NCT01821963|B1|Baseline|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
93530|NCT01821963|P1|Participant Flow|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
93531|NCT01821963|O1|Outcome|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
93574|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
93532|NCT01821963|E1|Reported Event|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
93533|NCT01821937|B3|Baseline|Total|Total of all reporting groups
93614|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
93534|NCT01821937|B2|Baseline|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93535|NCT01821937|B1|Baseline|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93536|NCT01821937|P2|Participant Flow|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93537|NCT01821937|P1|Participant Flow|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93538|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93539|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93540|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93541|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93542|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93543|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93544|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93545|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93546|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93547|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93575|NCT01821534|E1|Reported Event|All Participants|Healthy volunteers. No treatment (intervention) was administered.
93576|NCT01821417|B3|Baseline|Total|Total of all reporting groups
93609|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
93610|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
93548|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93615|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
93616|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
93549|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93550|NCT01821937|E4|Reported Event|Faldaprevir 240 mg Multiple Dose|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93551|NCT01821937|E3|Reported Event|Faldaprevir 240 mg Single Dose|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1."
93552|NCT01821937|E2|Reported Event|Faldaprevir 120 mg Multiple Dose|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
93553|NCT01821937|E1|Reported Event|Faldaprevir 120 mg Single Dose|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.
The study was divided into two phases, the first being a single dose and the second a multiple dose.
During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1."
93554|NCT01821859|B1|Baseline|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.
Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.
Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.
Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
93555|NCT01821859|P1|Participant Flow|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.
Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.
Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.
Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
93556|NCT01821859|O1|Outcome|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.
Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.
Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.
Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
93557|NCT01821859|E1|Reported Event|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.
Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.
Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.
Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
93558|NCT01821807|B3|Baseline|Total|Total of all reporting groups
93559|NCT01821807|B2|Baseline|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
93560|NCT01821807|B1|Baseline|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
93561|NCT01821807|P2|Participant Flow|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
93562|NCT01821807|P1|Participant Flow|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
93563|NCT01821807|O2|Outcome|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
93564|NCT01821807|O1|Outcome|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
93565|NCT01821807|O2|Outcome|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
93566|NCT01821807|O1|Outcome|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
93567|NCT01821807|E2|Reported Event|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
93568|NCT01821807|E1|Reported Event|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
93569|NCT01821534|B1|Baseline|All Participants|Healthy volunteers. No treatment (intervention) was administered.
93570|NCT01821534|P1|Participant Flow|All Participants|Healthy volunteers. No treatment (intervention) was administered.
93571|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
93572|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
93573|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
93577|NCT01821417|B2|Baseline|Dental Implant|"Randomized dental implant treatment with machined-collar implants
Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
93617|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone 20 mg once daily
93578|NCT01821417|B1|Baseline|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment
Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
93579|NCT01821417|P2|Participant Flow|Dental Implant|"Randomized dental implant treatment with machined-collar implants
Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
93580|NCT01821417|P1|Participant Flow|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment
Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
93581|NCT01821417|O2|Outcome|Dental Implant|"Randomized dental implant treatment with machined-collar implants
Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
93582|NCT01821417|O1|Outcome|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment
Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
93583|NCT01821417|O2|Outcome|Dental Implant|"Randomized dental implant treatment with machined-collar implants
Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
93584|NCT01821417|O1|Outcome|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment
Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
93585|NCT01821417|O2|Outcome|Dental Implant|"Randomized dental implant treatment with machined-collar implants
Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
93586|NCT01821417|O1|Outcome|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment
Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
93587|NCT01821417|E2|Reported Event|Dental Implant|"Serious adverse events are defined as life threatening events that occur during the course of the study treatment that may or may not be related to study protocols and procedures.
Other adverse events are defined as non-life threatening events that are unexpected after the routine performance of the study protocols and procedures. These may or may not be related to the study protocols and procedures."
93588|NCT01821417|E1|Reported Event|Microtextured Dental Implant|"Serious adverse events are defined as life threatening events that occur during the course of the study treatment that may or may not be related to study protocols and procedures.
Other adverse events are defined as non-life threatening events that are unexpected after the routine performance of the study protocols and procedures. These may or may not be related to the study protocols and procedures."
93589|NCT01821378|B4|Baseline|Total|Total of all reporting groups
93590|NCT01821378|B3|Baseline|Placebo|Placebo: Once Daily
93591|NCT01821378|B2|Baseline|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
93592|NCT01821378|B1|Baseline|Lurasidone 20 mg|"Lurasidone 20 mg once daily
Lurasidone: Lurasidone 20 mg once daily"
93593|NCT01821378|P3|Participant Flow|Placebo|"Placebo Comparator 20 or 80 mg once daily
Lurasidone: Lurasidone 20 mg once daily
Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily
Placebo: Once Daily"
93594|NCT01821378|P2|Participant Flow|Lurasidone 80 mg - 160 mg|"Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
Lurasidone: Lurasidone 20 mg once daily
Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily
Placebo: Once Daily"
93595|NCT01821378|P1|Participant Flow|Lurasidone 20 mg|"Lurasidone 20 mg once daily
Lurasidone: Lurasidone 20 mg once daily
Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily
Placebo: Once Daily"
93596|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
93597|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
93598|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
93599|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
93600|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
93601|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
93602|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
93603|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
93604|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
93605|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
93606|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
93607|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
93608|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
93611|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
93612|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
93622|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
93623|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone 20 mg once daily
93624|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
93625|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
93626|NCT01821378|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily
Lurasidone: Lurasidone 20 mg once daily"
93627|NCT01821378|E3|Reported Event|Placebo|Placebo: Once Daily
93628|NCT01821378|E2|Reported Event|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 (one subject who was randomized was not treated with study drug, therefore, excluded from the safety population).
93629|NCT01821378|E1|Reported Event|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
93630|NCT01821352|B3|Baseline|Total|Total of all reporting groups
93631|NCT01821352|B2|Baseline|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
93632|NCT01821352|B1|Baseline|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
93633|NCT01821352|P2|Participant Flow|Placebo Laser|Placebo Laser device emits sham green light that has no therapeutic effect.
93634|NCT01821352|P1|Participant Flow|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW) 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
93635|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
93636|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
93637|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
93638|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
93639|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
93640|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
93641|NCT01821352|E2|Reported Event|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
93642|NCT01821352|E1|Reported Event|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
93643|NCT01821326|B1|Baseline|Patients With Obscure Gastrointestinal Bleeding|
93644|NCT01821326|P1|Participant Flow|Patients With Obscure Gastrointestinal Bleeding|
93645|NCT01821326|O1|Outcome|Patients With Obscure Gastrointestinal Bleeding|
93646|NCT01821326|E1|Reported Event|Patients With Obscure Gastrointestinal Bleeding|
93647|NCT01821118|B3|Baseline|Total|Total of all reporting groups
93648|NCT01821118|B2|Baseline|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93649|NCT01821118|B1|Baseline|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93650|NCT01821118|P2|Participant Flow|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93651|NCT01821118|P1|Participant Flow|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93700|NCT01820585|O2|Outcome|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets
ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
93701|NCT01820585|O1|Outcome|Placebo|"Tablets
Placebo : Tablets"
93652|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93653|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93654|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93655|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93717|NCT01820559|E2|Reported Event|ESL 800 mg|"eslicarbazepine acetate 800 mg
ESL 800 mg :"
93718|NCT01820559|E1|Reported Event|Placebo|"Placebo tablets
Placebo : Tablets"
93656|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93657|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93658|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93659|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93660|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93661|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93662|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93663|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93664|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93665|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93666|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93667|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93668|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93669|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93670|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93671|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93672|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93673|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93674|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93675|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93702|NCT01820585|E4|Reported Event|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets
ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
93676|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93677|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93678|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93679|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93680|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93681|NCT01821118|E2|Reported Event|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
93682|NCT01821118|E1|Reported Event|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
93683|NCT01821105|B1|Baseline|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.
PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).
CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.
fludeoxyglucose F 18: Given IV
computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
93684|NCT01821105|P1|Participant Flow|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.
PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).
CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.
fludeoxyglucose F 18: Given IV
computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
93685|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.
PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).
CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.
fludeoxyglucose F 18: Given IV
computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
93686|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.
PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).
CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.
fludeoxyglucose F 18: Given IV
computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
93687|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.
PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).
CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.
fludeoxyglucose F 18: Given IV
computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
93688|NCT01821105|E1|Reported Event|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.
PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).
CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.
fludeoxyglucose F 18: Given IV
computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
93689|NCT01820585|B5|Baseline|Total|Total of all reporting groups
93690|NCT01820585|B4|Baseline|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets
ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
93691|NCT01820585|B3|Baseline|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets
ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
93692|NCT01820585|B2|Baseline|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets
ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
93693|NCT01820585|B1|Baseline|Placebo|"Tablets
Placebo : Tablets"
93694|NCT01820585|P4|Participant Flow|ESL 1200 mg|ESL was supplied in 400-mg and 600-mg tablets and was administered QD by oral route.
93695|NCT01820585|P3|Participant Flow|ESL 800 mg|ESL 800 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route
93696|NCT01820585|P2|Participant Flow|ESL 400 mg|Eslicarbazepine acetate (ESL) 400 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route.
93697|NCT01820585|P1|Participant Flow|Placebo|Placebo tablets matching the 400-mg and 600-mg tablets were administered Once daily (QD) by oral route.
93698|NCT01820585|O4|Outcome|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets
ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
93699|NCT01820585|O3|Outcome|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets
ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
94402|NCT01815099|O2|Outcome|Post rTMS Treatment|Assessment After Completing rTMS
93703|NCT01820585|E3|Reported Event|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets
ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
93704|NCT01820585|E2|Reported Event|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets
ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
93705|NCT01820585|E1|Reported Event|Placebo|"Tablets
Placebo : Tablets"
93706|NCT01820559|B4|Baseline|Total|Total of all reporting groups
93707|NCT01820559|B3|Baseline|ESL 1200 mg|"eslicarbazepine acetate 1200 mg
ESL 1200 mg :"
93708|NCT01820559|B2|Baseline|ESL 800 mg|"eslicarbazepine acetate 800 mg
ESL 800 mg :"
93709|NCT01820559|B1|Baseline|Placebo|"Placebo tablets
Placebo : Tablets"
93710|NCT01820559|P3|Participant Flow|ESL 1200 mg|"eslicarbazepine acetate 1200 mg
ESL 1200 mg :"
93711|NCT01820559|P2|Participant Flow|ESL 800 mg|"eslicarbazepine acetate 800 mg
ESL 800 mg :"
93712|NCT01820559|P1|Participant Flow|Placebo|"Placebo tablets
Placebo : Tablets"
93713|NCT01820559|O3|Outcome|ESL 1200 mg|"eslicarbazepine acetate 1200 mg
ESL 1200 mg :"
93720|NCT01820416|B3|Baseline|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
93721|NCT01820416|B2|Baseline|Disabled Laser|Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
93722|NCT01820416|B1|Baseline|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
93723|NCT01820416|P3|Participant Flow|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
93724|NCT01820416|P2|Participant Flow|Disabled Laser|"Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
Placebo Comparator: Disabled Laser: Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation."
93725|NCT01820416|P1|Participant Flow|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
93726|NCT01820416|O3|Outcome|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
93727|NCT01820416|O2|Outcome|Disabled Laser|"Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
Placebo Comparator: Disabled Laser: Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation."
93728|NCT01820416|O1|Outcome|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
93729|NCT01820416|E3|Reported Event|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
93730|NCT01820416|E2|Reported Event|Disabled Laser|Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
93731|NCT01820416|E1|Reported Event|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
93732|NCT01820364|B1|Baseline|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
93733|NCT01820364|P2|Participant Flow|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
93734|NCT01820364|P1|Participant Flow|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
93735|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
93736|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
93737|NCT01820364|O1|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
93738|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
93739|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
93740|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
93741|NCT01820364|O1|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
93742|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
93743|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
93744|NCT01820364|E1|Reported Event|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
93745|NCT01819935|B3|Baseline|Total|Total of all reporting groups
93746|NCT01819935|B2|Baseline|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
93747|NCT01819935|B1|Baseline|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
93748|NCT01819935|P2|Participant Flow|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
93749|NCT01819935|P1|Participant Flow|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
93750|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
93751|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
93752|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
93753|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
93754|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
93755|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
93756|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
93757|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
93758|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
93759|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
94403|NCT01815099|O1|Outcome|Pre rTMS Treatment|Assessment before beginning rTMS treatment
93760|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
93761|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
93762|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
93763|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
93786|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93764|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
93765|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
93766|NCT01819935|E2|Reported Event|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
93767|NCT01819935|E1|Reported Event|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
93768|NCT01819922|B1|Baseline|Overall Participants|All randomized participants who received single dose of PF-05175157 600 mg capsule or single dose of placebo matched to PF-05175157 600 mg capsule in either first or second intervention period.
93769|NCT01819922|P2|Participant Flow|Placebo Then PF-05175157|Participants who met the pre-defined CPET criteria, received single dose of placebo matched to PF-05175157, 600 mg capsule orally in first intervention period then single dose of PF-05175157 600 mg capsule orally in second intervention period. A washout period at least of 7-10 days was maintained between each intervention period.
93770|NCT01819922|P1|Participant Flow|PF-05175157 Then Placebo|Participants who met the pre-defined cardiopulmonary exercise test (CPET) criteria, received single dose of PF-05175157 600 milligram (mg) capsule orally in first intervention period then single dose of placebo matched to PF-05175157 capsule, 600 mg orally in second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93771|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93772|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93773|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93774|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93775|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93776|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93777|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93778|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93779|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93780|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93876|NCT01819415|O3|Outcome|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
93781|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93782|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93783|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93784|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93785|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93787|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93788|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93789|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93790|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93791|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93792|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93793|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93794|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93795|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93796|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93797|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93798|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93799|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93800|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93801|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93802|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93803|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93804|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93877|NCT01819415|O2|Outcome|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
93805|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93806|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93807|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93808|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93809|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93810|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93811|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93812|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93813|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93814|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93815|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93816|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93817|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93818|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93819|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93820|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93821|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93822|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93823|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93824|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93825|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93826|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93827|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93828|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93878|NCT01819415|O1|Outcome|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
93829|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93830|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93831|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93832|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93833|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93834|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93835|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93836|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93837|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93838|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93839|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93840|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93841|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93842|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93843|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93844|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93845|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93846|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93847|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93848|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93849|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93850|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93851|NCT01819922|E2|Reported Event|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93852|NCT01819922|E1|Reported Event|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
93853|NCT01819844|B1|Baseline|Closed-loop Blood Glucose Control|
94116|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
93854|NCT01819844|P1|Participant Flow|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.
Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
93855|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.
Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
93884|NCT01819311|B2|Baseline|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
93856|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.
Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
93857|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.
Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
93858|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.
Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
93859|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.
Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
93860|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.
Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
93861|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|
93862|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|
93863|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|"Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.
Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg)."
93864|NCT01819844|O1|Outcome|Closed-loop Blood Glucose Control|
93865|NCT01819844|E1|Reported Event|Closed-loop Blood Glucose Control|
93866|NCT01819415|B5|Baseline|Total|Total of all reporting groups
93867|NCT01819415|B4|Baseline|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
93868|NCT01819415|B3|Baseline|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
93869|NCT01819415|B2|Baseline|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
93870|NCT01819415|B1|Baseline|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
93871|NCT01819415|P4|Participant Flow|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
93872|NCT01819415|P3|Participant Flow|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
93873|NCT01819415|P2|Participant Flow|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
93874|NCT01819415|P1|Participant Flow|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
93875|NCT01819415|O4|Outcome|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
94404|NCT01815099|E1|Reported Event|rTMS Treatment|rTMS Treatment: will entail twice weekly rTMS sessions for 5 weeks.
93879|NCT01819415|E4|Reported Event|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
93880|NCT01819415|E3|Reported Event|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
93881|NCT01819415|E2|Reported Event|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
93882|NCT01819415|E1|Reported Event|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
93883|NCT01819311|B3|Baseline|Total|Total of all reporting groups
93931|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93932|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
95240|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
93885|NCT01819311|B1|Baseline|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
93886|NCT01819311|P2|Participant Flow|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
93887|NCT01819311|P1|Participant Flow|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
93888|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
93889|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
93890|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
93891|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
93892|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
93893|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
93894|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
93895|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
93896|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
93933|NCT01819272|E6|Reported Event|2000 mg XR|"2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
95241|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
93897|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
93898|NCT01819311|O2|Outcome|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
93899|NCT01819311|O1|Outcome|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
93900|NCT01819311|E2|Reported Event|Placebo Attention Task|"The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability."
93901|NCT01819311|E1|Reported Event|Attention Bias Modification|"Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders."
93902|NCT01819272|B7|Baseline|Total|Total of all reporting groups
93903|NCT01819272|B6|Baseline|2000 mg XR|"2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
93904|NCT01819272|B5|Baseline|1000 mg XR|"1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
93905|NCT01819272|B4|Baseline|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93906|NCT01819272|B3|Baseline|800 mg DR|"800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93907|NCT01819272|B2|Baseline|600 mg DR|"600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93908|NCT01819272|B1|Baseline|Placebo|Placebo once daily in the morning
93909|NCT01819272|P6|Participant Flow|2000 mg XR|"2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
93910|NCT01819272|P5|Participant Flow|1000 mg XR|"1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
93911|NCT01819272|P4|Participant Flow|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93912|NCT01819272|P3|Participant Flow|800 mg DR|"800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93913|NCT01819272|P2|Participant Flow|600 mg DR|"600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93914|NCT01819272|P1|Participant Flow|Placebo|Placebo once daily in the morning
93915|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
93916|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
93917|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93918|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93919|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93920|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
93921|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
93922|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
95265|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
93923|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93924|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93925|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93926|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
93927|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
93928|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
93929|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93930|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93934|NCT01819272|E5|Reported Event|1000 mg XR|"1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets"
93935|NCT01819272|E4|Reported Event|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93936|NCT01819272|E3|Reported Event|800 mg DR|"800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93937|NCT01819272|E2|Reported Event|600 mg DR|"600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets"
93938|NCT01819272|E1|Reported Event|Placebo|Placebo once daily in the morning
93939|NCT01819194|B1|Baseline|Dispensed Subjects|All subjects that were dispensed the study lens.
93940|NCT01819194|P1|Participant Flow|Overall|Subjects only wore one lens: senofilcon A, 38% water. Subjects, were enrolled and screened per inclusion/exclusion criteria.
93941|NCT01819194|O1|Outcome|Senofilcon A, 38% Water|Senofilcon A, 38% water
93942|NCT01819194|O1|Outcome|Senofilcon A, 38% Water|Senofilcon A, 38% water
93943|NCT01819194|E1|Reported Event|Senofilcon A, 38% Water|Senofilcon A, 38% water
93944|NCT01818752|B3|Baseline|Total|Total of all reporting groups
93945|NCT01818752|B2|Baseline|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93946|NCT01818752|B1|Baseline|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93947|NCT01818752|P2|Participant Flow|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93948|NCT01818752|P1|Participant Flow|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93949|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93950|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93951|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93952|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93953|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93954|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93955|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93956|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
94002|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
93957|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93958|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93959|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93960|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93961|NCT01818752|O2|Outcome|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93962|NCT01818752|O1|Outcome|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93963|NCT01818752|E2|Reported Event|Carfilzomib, Melphalan, Prednisone|Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93964|NCT01818752|E1|Reported Event|Bortezomib, Melphalan, Prednisone|Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
93965|NCT01818700|B1|Baseline|Norspan Patch (Buprenorphine)|"Trade name is Norspan. Buprenorphine 5μg/h, 10 μg/h, 20 μg/h patches will be used (4 patches a box). Patch will be administered every 7th day.
Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
93966|NCT01818700|P1|Participant Flow|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
93967|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
93993|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
93994|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
93968|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
93969|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
94032|NCT01818141|B3|Baseline|Total|Total of all reporting groups
93970|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
93971|NCT01818700|O1|Outcome|Single Arm-Norspan Patch (Buprenorphine)|"This trial is single arm with Norspan patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
93972|NCT01818700|O1|Outcome|Single Arm-Norspan Patch (Buprenorphine)|This study is single study with buprenorphine. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
93973|NCT01818700|E1|Reported Event|Norspan Patch (Buprenorphine)|"Trade name is Norspan. Buprenorphine 5μg/h, 10 μg/h, 20 μg/h patches will be used (4 patches a box). Patch will be administered every 7th day.
Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
93974|NCT01818596|B3|Baseline|Total|Total of all reporting groups
93975|NCT01818596|B2|Baseline|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
93976|NCT01818596|B1|Baseline|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
93977|NCT01818596|P2|Participant Flow|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
93978|NCT01818596|P1|Participant Flow|Cohort 1 (Treatment-experienced)|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-experienced participants
93979|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
93980|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
93981|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
93982|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
93983|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
93984|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
93985|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
93986|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
93987|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
93988|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
93989|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
93990|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
93991|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
93992|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
94685|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
93995|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
93996|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
93997|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
93998|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
93999|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
94000|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
94001|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
94208|NCT01816685|E2|Reported Event|Routine Care|Routine care will be provided to the participant.
94003|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
94004|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
94005|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
94006|NCT01818596|E2|Reported Event|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-naive participants
94007|NCT01818596|E1|Reported Event|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-experienced participants
94008|NCT01818414|B3|Baseline|Total|Total of all reporting groups
94009|NCT01818414|B2|Baseline|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
Folic Acid"
94010|NCT01818414|B1|Baseline|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
Misoprostol"
94011|NCT01818414|P2|Participant Flow|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
Folic Acid"
94012|NCT01818414|P1|Participant Flow|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
Misoprostol"
94013|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
Folic Acid"
94014|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
Misoprostol"
94015|NCT01818414|O2|Outcome|Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
94016|NCT01818414|O1|Outcome|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
94017|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
Folic Acid"
94018|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
Misoprostol"
94019|NCT01818414|O2|Outcome|Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
94020|NCT01818414|O1|Outcome|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
94021|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
Folic Acid"
94022|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
Misoprostol"
94023|NCT01818414|E2|Reported Event|Placebo Comparator: Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
94024|NCT01818414|E1|Reported Event|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S
94025|NCT01818336|B1|Baseline|Safety Population|All subjects who had skin testing performed (i.e., administered any component of the Penicillin Skin Test Kit).
94026|NCT01818336|P2|Participant Flow|Subjects in Retest Population|All subjects who initially tested positive to any of the initial skin tests with penicillin reagents and subsequently returned after 4 weeks for retesting.
94027|NCT01818336|P1|Participant Flow|Intent-to-Treat Population|All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine and control results were valid) and who received the oral amoxicillin challenge.
94028|NCT01818336|O1|Outcome|Intent-to-Treat Population|All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine control results are valid) and who receive the oral amoxicillin challenge.
94029|NCT01818336|E3|Reported Event|Subjects With AE Related to Oral Amox Challenge|"Intervention: Penicillin skin test kit
The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge."
94067|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
94068|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
94686|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
94030|NCT01818336|E2|Reported Event|Subjects With AE Related to Skin Testing|"Intervention: Penicillin skin test kit
The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s)."
94031|NCT01818336|E1|Reported Event|Safety Population-All Study-Emergent Adverse Events|"Intervention: Penicillin skin test kit
The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge."
94033|NCT01818141|B2|Baseline|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
94034|NCT01818141|B1|Baseline|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days
Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
94035|NCT01818141|P2|Participant Flow|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
94036|NCT01818141|P1|Participant Flow|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days
Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
94037|NCT01818141|O2|Outcome|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
94038|NCT01818141|O1|Outcome|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days
Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
94039|NCT01818141|O2|Outcome|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
94040|NCT01818141|O1|Outcome|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days
Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
94041|NCT01818141|E2|Reported Event|Vancomycin|"Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days"
94042|NCT01818141|E1|Reported Event|Fidaxomicin|"Fidaxomicin 200mg by mouth every 12 hours for 10 days
Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days"
94043|NCT01817907|B3|Baseline|Total|Total of all reporting groups
94044|NCT01817907|B2|Baseline|Trazodone First|"Subjects will receive trazodone during their treatment night sleep study
Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
94045|NCT01817907|B1|Baseline|Placebo First|"Subjects will receive a sugar pill during their placebo night sleep study.
Placebo pill: Subjects will receive a sugar pill during the placebo arm"
94046|NCT01817907|P2|Participant Flow|Trazodone First|Subjects will receive a pill of trazodone (100 mg) during their first sleep study night and will receive a sugar pill (placebo) during their second sleep study night.
94047|NCT01817907|P1|Participant Flow|Placebo First|Subjects will receive a sugar pill (placebo) during their first sleep study night and will receive a pill of trazodone (100 mg) during their second sleep study night.
94048|NCT01817907|O2|Outcome|Trazodone|"Subjects will receive trazodone during their treatment night sleep study
Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
94049|NCT01817907|O1|Outcome|Placebo|"Subjects will receive a sugar pill during their placebo night sleep study.
Placebo pill: Subjects will receive a sugar pill during the placebo arm"
94050|NCT01817907|O2|Outcome|Trazodone|"Subjects will receive trazodone during their treatment night sleep study
Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
94051|NCT01817907|O1|Outcome|Placebo|"Subjects will receive a sugar pill during their placebo night sleep study.
Placebo pill: Subjects will receive a sugar pill during the placebo arm"
94052|NCT01817907|E2|Reported Event|Trazodone|"Subjects will receive trazodone during their treatment night sleep study
Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
94053|NCT01817907|E1|Reported Event|Placebo|"Subjects will receive a sugar pill during their placebo night sleep study.
Placebo pill: Subjects will receive a sugar pill during the placebo arm"
94054|NCT01817855|B5|Baseline|Total|Total of all reporting groups
94055|NCT01817855|B4|Baseline|Placebo COPD|COPD Patients with Placebo, once daily
94056|NCT01817855|B3|Baseline|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
94057|NCT01817855|B2|Baseline|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
94058|NCT01817855|B1|Baseline|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
94059|NCT01817855|P4|Participant Flow|Placebo COPD|COPD Patients with Placebo, once daily
94060|NCT01817855|P3|Participant Flow|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
94061|NCT01817855|P2|Participant Flow|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
94062|NCT01817855|P1|Participant Flow|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
94063|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
94064|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
94065|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
94066|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
94069|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
94070|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
94071|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
94072|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
94073|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
94074|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
94075|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
94076|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
94077|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
94078|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
94079|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
94080|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
94081|NCT01817855|O4|Outcome|Placebo COPD|COPD Patients with Placebo, once daily
94082|NCT01817855|O3|Outcome|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
94083|NCT01817855|O2|Outcome|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
94084|NCT01817855|O1|Outcome|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
94085|NCT01817855|E4|Reported Event|Placebo COPD|COPD Patients with Placebo, once daily
94086|NCT01817855|E3|Reported Event|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
94087|NCT01817855|E2|Reported Event|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
94088|NCT01817855|E1|Reported Event|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
94089|NCT01817790|B3|Baseline|Total|Total of all reporting groups
94090|NCT01817790|B2|Baseline|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94091|NCT01817790|B1|Baseline|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94092|NCT01817790|P2|Participant Flow|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94093|NCT01817790|P1|Participant Flow|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94094|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94095|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94096|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94097|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94098|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94099|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94100|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94101|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94102|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94103|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94104|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94105|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94106|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94107|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94108|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94109|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94110|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94111|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94112|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94113|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94114|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94115|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94117|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94118|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94119|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94120|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning
94121|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94122|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning
94123|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94124|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94125|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94126|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94127|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94128|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94129|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94130|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94131|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.
94132|NCT01817790|E2|Reported Event|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
94133|NCT01817790|E1|Reported Event|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
94134|NCT01817777|B3|Baseline|Total|Total of all reporting groups
94135|NCT01817777|B2|Baseline|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94136|NCT01817777|B1|Baseline|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94137|NCT01817777|P3|Participant Flow|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94138|NCT01817777|P2|Participant Flow|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94139|NCT01817777|P1|Participant Flow|Routine Metformin|Participants were followed during an 8-week Observational Phase. During this phase, participants visited the pharmacy and purchased metformin (MTF) as per their usual routines.
94140|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94141|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94142|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94143|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94144|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94145|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94146|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94334|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94147|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94148|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94149|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94150|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94151|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94152|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94153|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94154|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94155|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94156|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94157|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94158|NCT01817777|E2|Reported Event|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
94159|NCT01817777|E1|Reported Event|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
94160|NCT01817764|B3|Baseline|Total|Total of all reporting groups
94161|NCT01817764|B2|Baseline|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
94162|NCT01817764|B1|Baseline|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
94163|NCT01817764|P2|Participant Flow|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
94164|NCT01817764|P1|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
94165|NCT01817764|O2|Outcome|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
94166|NCT01817764|O1|Outcome|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
94167|NCT01817764|O2|Outcome|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
94168|NCT01817764|O1|Outcome|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
94169|NCT01817764|E2|Reported Event|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
94170|NCT01817764|E1|Reported Event|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
94171|NCT01817725|B1|Baseline|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old
HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old."
94172|NCT01817725|P1|Participant Flow|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old
HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
94209|NCT01816685|E1|Reported Event|CPAP|"Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
CPAP"
94210|NCT01816477|B3|Baseline|Total|Total of all reporting groups
94173|NCT01817725|O1|Outcome|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old
HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
94174|NCT01817725|O1|Outcome|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old
HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
94175|NCT01817725|E1|Reported Event|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old
HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
94176|NCT01816776|B3|Baseline|Total|Total of all reporting groups
94177|NCT01816776|B2|Baseline|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
94178|NCT01816776|B1|Baseline|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
94179|NCT01816776|P2|Participant Flow|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
94180|NCT01816776|P1|Participant Flow|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
94181|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
94182|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
94183|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
94184|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
94185|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
94186|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
94187|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
94188|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
94189|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
94190|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
94191|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
94192|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
94193|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
94194|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
94195|NCT01816776|O1|Outcome|Pooled Group|All randomized participants pooled. All subjects were implanted with the remedē System device and received optimal medical therapy. The Treatment group had received 12 months active therapy and Control had received 6 months active therapy.
94196|NCT01816776|O2|Outcome|Control Group|Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
94197|NCT01816776|O1|Outcome|Treatment Group|Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
94198|NCT01816776|E1|Reported Event|Pooled Group|All randomized participants pooled. All subjects were implanted with the remedē System device and received optimal medical therapy. The Treatment group had received 12 months active therapy and Control had received 6 months active therapy.
94199|NCT01816685|B3|Baseline|Total|Total of all reporting groups
94200|NCT01816685|B2|Baseline|Routine Care|Routine care will be provided to the participant.
94201|NCT01816685|B1|Baseline|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
94202|NCT01816685|P2|Participant Flow|Routine Care|Routine care will be provided to the participant.
94687|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
94203|NCT01816685|P1|Participant Flow|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
94204|NCT01816685|O2|Outcome|Routine Care|Routine care will be provided to the participant.
94205|NCT01816685|O1|Outcome|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
94206|NCT01816685|O2|Outcome|Routine Care|Routine care will be provided to the participant.
94207|NCT01816685|O1|Outcome|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
94211|NCT01816477|B2|Baseline|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
94212|NCT01816477|B1|Baseline|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
94213|NCT01816477|P2|Participant Flow|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
94214|NCT01816477|P1|Participant Flow|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
94215|NCT01816477|O2|Outcome|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
94216|NCT01816477|O1|Outcome|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
94217|NCT01816477|O2|Outcome|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
94218|NCT01816477|O1|Outcome|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
94219|NCT01816477|O2|Outcome|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
94220|NCT01816477|O1|Outcome|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
94221|NCT01816477|E2|Reported Event|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
94222|NCT01816477|E1|Reported Event|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
94223|NCT01816451|B4|Baseline|Total|Total of all reporting groups
94224|NCT01816451|B3|Baseline|Control|The control group did not do the running training program. Control did their normal physical activities.
94225|NCT01816451|B2|Baseline|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94226|NCT01816451|B1|Baseline|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax-maximal heart rate (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94227|NCT01816451|P3|Participant Flow|Control|The control group did not do the running training program. Control did their normal physical activities.
94228|NCT01816451|P2|Participant Flow|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94399|NCT01815645|E1|Reported Event|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
94229|NCT01816451|P1|Participant Flow|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94230|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
94231|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94305|NCT01815918|B1|Baseline|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.
Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
94232|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94233|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
94234|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94235|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94236|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
94237|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94238|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94239|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
94240|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94241|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94242|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94243|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94244|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94245|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94335|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94246|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94247|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94690|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
94248|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94249|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94250|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
94251|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94252|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94253|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
94254|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94255|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94256|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
94257|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94258|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94259|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
94260|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine.The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94261|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax-maximal heart rate (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94262|NCT01816451|E3|Reported Event|Control|The control group did not do the running training program. Control did their normal physical activities.
94263|NCT01816451|E2|Reported Event|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
94400|NCT01815099|B1|Baseline|rTMS Treatment|rTMS Treatment: will entail twice weekly rTMS sessions for 5 weeks.
94264|NCT01816451|E1|Reported Event|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
94265|NCT01816295|B3|Baseline|Total|Total of all reporting groups
94266|NCT01816295|B2|Baseline|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
95326|NCT01809938|O2|Outcome|Tea With Milk|Tea with milk : 250ml of black tea with 50ml of full fat milk
94267|NCT01816295|B1|Baseline|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94268|NCT01816295|P2|Participant Flow|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94269|NCT01816295|P1|Participant Flow|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94270|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94271|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94272|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94273|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94274|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94275|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94276|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94277|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94278|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94279|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
94280|NCT01816295|E3|Reported Event|Testosterone Solution - OLE|Sixty mg testosterone solution applied topically to axillae once daily at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks in optional OLE period.
94281|NCT01816295|E2|Reported Event|Testosterone Solution - Double Blind|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period.
94282|NCT01816295|E1|Reported Event|Placebo Solution - Double Blind|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period.
94283|NCT01816243|B1|Baseline|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
94284|NCT01816243|P1|Participant Flow|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
94336|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94285|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
94304|NCT01815918|B2|Baseline|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
94286|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
94287|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
94288|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
94289|NCT01816243|E1|Reported Event|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
94290|NCT01816048|B1|Baseline|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan
Positron Emission Tomography: Undergo 18F NaF PET/CT scan
Computed Tomography: Undergo 18F NaF PET/CT scan"
94291|NCT01816048|P1|Participant Flow|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan
Positron Emission Tomography: Undergo 18F NaF PET/CT scan
Computed Tomography: Undergo 18F NaF PET/CT scan"
94292|NCT01816048|O1|Outcome|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan
Positron Emission Tomography: Undergo 18F NaF PET/CT scan
Computed Tomography: Undergo 18F NaF PET/CT scan"
94293|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
94294|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
94295|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
94296|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
94297|NCT01816048|O1|Outcome|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan
Positron Emission Tomography: Undergo 18F NaF PET/CT scan
Computed Tomography: Undergo 18F NaF PET/CT scan"
94298|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
94299|NCT01816048|O1|Outcome|TAK-700|"TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12"
94300|NCT01816048|O1|Outcome|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan
Positron Emission Tomography: Undergo 18F NaF PET/CT scan
Computed Tomography: Undergo 18F NaF PET/CT scan"
94301|NCT01816048|O1|Outcome|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan
Positron Emission Tomography: Undergo 18F NaF PET/CT scan
Computed Tomography: Undergo 18F NaF PET/CT scan"
94337|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94302|NCT01816048|E1|Reported Event|TAK-700|"TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan
Positron Emission Tomography: Undergo 18F NaF PET/CT scan
Computed Tomography: Undergo 18F NaF PET/CT scan"
94303|NCT01815918|B3|Baseline|Total|Total of all reporting groups
94691|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
94306|NCT01815918|P2|Participant Flow|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
94307|NCT01815918|P1|Participant Flow|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.
Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
94308|NCT01815918|O2|Outcome|Treatment|
94309|NCT01815918|O1|Outcome|Placebo|
94310|NCT01815918|O2|Outcome|Treatment|
94311|NCT01815918|O1|Outcome|Placebo|
94312|NCT01815918|O2|Outcome|Treatment|Data was not collected
94313|NCT01815918|O1|Outcome|Placebo|Data was not collected
94314|NCT01815918|O2|Outcome|Treatment|
94315|NCT01815918|O1|Outcome|Placebo|
94316|NCT01815918|O2|Outcome|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
94317|NCT01815918|O1|Outcome|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.
Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
94318|NCT01815918|E2|Reported Event|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
94319|NCT01815918|E1|Reported Event|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.
Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
94320|NCT01815840|B3|Baseline|Total|Total of all reporting groups
94321|NCT01815840|B2|Baseline|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94322|NCT01815840|B1|Baseline|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94323|NCT01815840|P2|Participant Flow|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94324|NCT01815840|P1|Participant Flow|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94325|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94326|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94327|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94328|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94329|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94330|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94331|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94332|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94333|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94401|NCT01815099|P1|Participant Flow|rTMS Treatment|This was an open trial. All participants received active rTMS
94338|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94339|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94340|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94341|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94342|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94343|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94344|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94345|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94346|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94347|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94348|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94349|NCT01815840|E2|Reported Event|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94350|NCT01815840|E1|Reported Event|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
94351|NCT01815736|B3|Baseline|Total|Total of all reporting groups
94352|NCT01815736|B2|Baseline|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
94353|NCT01815736|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
94354|NCT01815736|P2|Participant Flow|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF (Stribild®); efavirenz (EFV)/FTC/TDF (Atripla®); ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
94355|NCT01815736|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
94356|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
94357|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
94358|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
94359|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
94360|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
94361|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
94362|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
94363|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
94364|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
94365|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
94366|NCT01815736|E2|Reported Event|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
94692|NCT01813890|E3|Reported Event|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
94367|NCT01815736|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
94368|NCT01815671|B3|Baseline|Total|Total of all reporting groups
94369|NCT01815671|B2|Baseline|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
94370|NCT01815671|B1|Baseline|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
94371|NCT01815671|P2|Participant Flow|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
94372|NCT01815671|P1|Participant Flow|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
94373|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
94374|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
94375|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
94376|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
94377|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
94378|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
94379|NCT01815671|E2|Reported Event|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
94380|NCT01815671|E1|Reported Event|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
94381|NCT01815645|B3|Baseline|Total|Total of all reporting groups
94382|NCT01815645|B2|Baseline|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
94383|NCT01815645|B1|Baseline|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
94384|NCT01815645|P2|Participant Flow|Standard Treatment Plus Contingency Management|33 participants received Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
94385|NCT01815645|P1|Participant Flow|Standard Treatment|standard treatment: 32 participants received 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
94386|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|33 participants received Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
94387|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 32 participants received 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
94388|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|33 participants received Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
94389|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 32 participants received 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
94390|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
94391|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
94392|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
94393|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
94394|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|33 participants received Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
94395|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 32 participants received 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
94396|NCT01815645|O2|Outcome|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
94397|NCT01815645|O1|Outcome|Standard Treatment|standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
94398|NCT01815645|E2|Reported Event|Standard Treatment Plus Contingency Management|Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
94405|NCT01815008|B1|Baseline|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily
Clopidogrel: Clopidogrel 75 mg daily
Aspirin: Aspirin 81 mg daily"
94406|NCT01815008|P1|Participant Flow|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily
Clopidogrel: Clopidogrel 75 mg daily
Aspirin: Aspirin 81 mg daily"
94407|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily
Clopidogrel: Clopidogrel 75 mg daily
Aspirin: Aspirin 81 mg daily
Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding."
94812|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94408|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily
Clopidogrel: Clopidogrel 75 mg daily
Aspirin: Aspirin 81 mg daily"
94409|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily
Clopidogrel: Clopidogrel 75 mg daily
Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding."
94410|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily
Clopidogrel: Clopidogrel 75 mg daily
Aspirin: Aspirin 81 mg daily"
94411|NCT01815008|E1|Reported Event|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily
Clopidogrel: Clopidogrel 75 mg daily
Aspirin: Aspirin 81 mg daily"
94412|NCT01814878|B3|Baseline|Total|Total of all reporting groups
94413|NCT01814878|B2|Baseline|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
94414|NCT01814878|B1|Baseline|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
94415|NCT01814878|P2|Participant Flow|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
94416|NCT01814878|P1|Participant Flow|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
94417|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
94418|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
94419|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
94420|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
94421|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
94422|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
94423|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
94424|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
94425|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
94426|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
94427|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
94428|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
94429|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
94693|NCT01813890|E2|Reported Event|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
94430|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
94431|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
94432|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
94433|NCT01814878|E2|Reported Event|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
94434|NCT01814878|E1|Reported Event|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
94435|NCT01814800|B1|Baseline|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94436|NCT01814800|P1|Participant Flow|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg IV infusion Frequency: Every 3 or 4 weeks
Initial dose selection based on prior IGIV regimen, doses adjusted during study to maintain trough Immunoglobulin G (IgG) concentration of 500 mg/dL or greater according to investigator decision."
94437|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94438|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94439|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94440|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94441|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94442|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94443|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94444|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94445|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94446|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94447|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94448|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94449|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94450|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94451|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94452|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94453|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94454|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94455|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94456|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94457|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94458|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94459|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94460|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94461|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94462|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94463|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94464|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94465|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94466|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94467|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94468|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94469|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94470|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94471|NCT01814800|E1|Reported Event|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion
RI-002"
94472|NCT01814787|B3|Baseline|Total|Total of all reporting groups
94488|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
95451|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
94473|NCT01814787|B2|Baseline|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
94474|NCT01814787|B1|Baseline|CHICA Type 2 Diabetes Module|"Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.
CHICA Type 2 Diabetes Module: Information with regard to family history of type 2 diabetes, race/ethnicity, and maternal history of gestational diabetes will be gathered for every patient. This data will then be utilized by the CHICA system when a child is age 10 or older and presents to the clinic. Data regarding the child's BMI at that time will be analyzed by the CHICA system."
94475|NCT01814787|P2|Participant Flow|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
94476|NCT01814787|P1|Participant Flow|CHICA Type 2 Diabetes Module|"Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.
CHICA Type 2 Diabetes Module: Information with regard to family history of type 2 diabetes, race/ethnicity, and maternal history of gestational diabetes will be gathered for every patient. This data will then be utilized by the CHICA system when a child is age 10 or older and presents to the clinic. Data regarding the child's BMI at that time will be analyzed by the CHICA system. If the child's BMI > 85th percentile, a prompt will appear on the provider worksheet asking the clinician"
94477|NCT01814787|O2|Outcome|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
94478|NCT01814787|O1|Outcome|CHICA Type 2 Diabetes Module|Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.
94479|NCT01814787|E2|Reported Event|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
94480|NCT01814787|E1|Reported Event|CHICA Type 2 Diabetes Module|Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.
94481|NCT01814774|B1|Baseline|All Participants|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
94482|NCT01814774|P1|Participant Flow|All Participants|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
94483|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
94484|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
94485|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
94486|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
94487|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
95452|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
94489|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
94490|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
94491|NCT01814774|E2|Reported Event|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
94492|NCT01814774|E1|Reported Event|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
94493|NCT01814761|B3|Baseline|Total|Total of all reporting groups
94494|NCT01814761|B2|Baseline|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94495|NCT01814761|B1|Baseline|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94496|NCT01814761|P2|Participant Flow|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94497|NCT01814761|P1|Participant Flow|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94498|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94499|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94500|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94501|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94502|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94503|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94504|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94505|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94506|NCT01814761|E2|Reported Event|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94507|NCT01814761|E1|Reported Event|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
94508|NCT01814748|B3|Baseline|Total|Total of all reporting groups
94509|NCT01814748|B2|Baseline|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94510|NCT01814748|B1|Baseline|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94511|NCT01814748|P2|Participant Flow|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94512|NCT01814748|P1|Participant Flow|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94513|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94514|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94515|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94516|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94517|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94518|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94519|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94520|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94521|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94522|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94523|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94524|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94525|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94526|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94527|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94528|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94529|NCT01814748|E2|Reported Event|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94530|NCT01814748|E1|Reported Event|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
94531|NCT01814722|B4|Baseline|Total|Total of all reporting groups
94532|NCT01814722|B3|Baseline|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
94533|NCT01814722|B2|Baseline|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
94534|NCT01814722|B1|Baseline|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
94535|NCT01814722|P3|Participant Flow|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
94536|NCT01814722|P2|Participant Flow|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
94537|NCT01814722|P1|Participant Flow|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
94538|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
94539|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
94540|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
94541|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
94542|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
94543|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
94544|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
94545|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
94546|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
94547|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
94548|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
94549|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
94550|NCT01814722|E3|Reported Event|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
94551|NCT01814722|E2|Reported Event|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
94552|NCT01814722|E1|Reported Event|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
94553|NCT01814696|B3|Baseline|Total|Total of all reporting groups
94554|NCT01814696|B2|Baseline|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
94555|NCT01814696|B1|Baseline|Control|Subjects will continue to receive usual medical care from their doctor(s).
94556|NCT01814696|P2|Participant Flow|Intervention|"Subjects will continue to receive usual medical care from their doctor(s).
Intervention: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
94557|NCT01814696|P1|Participant Flow|Control|"Subjects will continue to receive usual medical care from their doctor(s).
Subjects will follow their normal medication management routine."
94688|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
95453|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
94558|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
94559|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
94694|NCT01813890|E1|Reported Event|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
94695|NCT01813721|B1|Baseline|Primary Analysis Set|
94560|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
94561|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
94562|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
94563|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
94564|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
94565|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
94566|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
94567|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
94568|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
94569|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
94570|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
94571|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
94572|NCT01814696|E2|Reported Event|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
94573|NCT01814696|E1|Reported Event|Control|Subjects will continue to receive usual medical care from their doctor(s).
94574|NCT01814670|B1|Baseline|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
94575|NCT01814670|P1|Participant Flow|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
94576|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
94577|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
94578|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
94579|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
94580|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
94581|NCT01814670|E1|Reported Event|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
94582|NCT01814553|B3|Baseline|Total|Total of all reporting groups
94583|NCT01814553|B2|Baseline|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
94584|NCT01814553|B1|Baseline|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
94585|NCT01814553|P2|Participant Flow|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
94586|NCT01814553|P1|Participant Flow|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
94696|NCT01813721|P1|Participant Flow|All Enrolled Patients|Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
94697|NCT01813721|O1|Outcome|At or Above Investigator Threshold|
94698|NCT01813721|O4|Outcome|Small Cell Lung Cancer|
94587|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
94588|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
94589|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
94590|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
94591|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
94592|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
94593|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
94594|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
94595|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
94596|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
94597|NCT01814553|E2|Reported Event|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
94689|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
95461|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
94598|NCT01814553|E1|Reported Event|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
94599|NCT01814397|B1|Baseline|Women Starting Aromatase Inhibitor (AI) Therapy|There is only a single cohort. Postmenopausal women with estrogen receptor positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
94600|NCT01814397|P1|Participant Flow|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with hormone receptor positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
94601|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
94602|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
94603|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
94604|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
94605|NCT01814397|E1|Reported Event|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
94606|NCT01814332|B3|Baseline|Total|Total of all reporting groups
94607|NCT01814332|B2|Baseline|Placebo|"Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP"
94608|NCT01814332|B1|Baseline|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
94609|NCT01814332|P2|Participant Flow|Placebo|"Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP"
94610|NCT01814332|P1|Participant Flow|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
94611|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP"
94612|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
94613|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP"
94614|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
94615|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP"
94616|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
94617|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP"
94618|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
94619|NCT01814332|E2|Reported Event|Placebo|"Placebo compound treatment for comparison with IP
Placebo: Placebo compound treatment for comparison with IP"
94620|NCT01814332|E1|Reported Event|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration
GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
94621|NCT01814241|B1|Baseline|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
94622|NCT01814241|P1|Participant Flow|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
94623|NCT01814241|O1|Outcome|Open Label Peanut OIT|Subject cohort receiving open label orally ingested peanut flour with maintenance dose of 1450mg
94624|NCT01814241|O1|Outcome|Open Label Peanut OIT|Subject cohort receiving open label orally ingested peanut flour with maintenance dose of 1450mg
94625|NCT01814241|O1|Outcome|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
94626|NCT01814241|O1|Outcome|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
94627|NCT01814241|O1|Outcome|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
94628|NCT01814241|E1|Reported Event|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
94629|NCT01814137|B3|Baseline|Total|Total of all reporting groups
94654|NCT01814046|O2|Outcome|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
95462|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
94630|NCT01814137|B2|Baseline|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
94631|NCT01814137|B1|Baseline|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
94632|NCT01814137|P2|Participant Flow|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
94633|NCT01814137|P1|Participant Flow|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
94634|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
94635|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
94636|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
94679|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
94680|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
94681|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
94637|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
94638|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
94639|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
94640|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
94641|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
94642|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
94643|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
94682|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
94683|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
94684|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
94699|NCT01813721|O3|Outcome|Non-Hodgkin's Lymphoma|
94644|NCT01814137|E2|Reported Event|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
94645|NCT01814137|E1|Reported Event|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
94646|NCT01814046|B3|Baseline|Total|Total of all reporting groups
94647|NCT01814046|B2|Baseline|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
94648|NCT01814046|B1|Baseline|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
94649|NCT01814046|P3|Participant Flow|Cells + High-Dose Aldesleukin Retreatment|Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
94650|NCT01814046|P2|Participant Flow|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
94651|NCT01814046|P1|Participant Flow|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
94652|NCT01814046|O2|Outcome|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
94653|NCT01814046|O1|Outcome|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
94655|NCT01814046|O1|Outcome|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
94656|NCT01814046|O2|Outcome|Cells and no High Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
94657|NCT01814046|O1|Outcome|Cells + High Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
94658|NCT01814046|E3|Reported Event|Cells + High-Dose Aldesleukin Retreatment|Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
94659|NCT01814046|E2|Reported Event|Cells and No High-Dose Aldesleukin|"Patients receiving cells and no high dose aldesleukin
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young TIL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
94660|NCT01814046|E1|Reported Event|Cells + High-Dose Aldesleukin|"Patients receiving cells + high dose aldesleukin
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Young tumor infiltrating lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
94661|NCT01813890|B4|Baseline|Total|Total of all reporting groups
94662|NCT01813890|B3|Baseline|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
94663|NCT01813890|B2|Baseline|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
94664|NCT01813890|B1|Baseline|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
94665|NCT01813890|P3|Participant Flow|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
94666|NCT01813890|P2|Participant Flow|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
94667|NCT01813890|P1|Participant Flow|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
94668|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
94669|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
94670|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
94671|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
94672|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
94673|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
94674|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
94675|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
94676|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
94677|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
94678|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
94746|NCT01813721|E1|Reported Event|All Enrolled Patients|Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
94747|NCT01813110|B1|Baseline|Baseline|Baseline (prior to placebo or omega-3 supplementation)
94748|NCT01813110|P2|Participant Flow|Omega-3 Fatty Acids (8 Weeks), Then Placebo (8 Weeks)|8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) followed by 8 weeks of placebo (olive oil) supplementation
94749|NCT01813110|P1|Participant Flow|Placebo (8 Weeks), Then Omega-3 Fatty Acids (8 Weeks)|8 weeks of placebo (olive oil) supplementation followed by 8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate)
94750|NCT01813110|O2|Outcome|Omega-3 Fatty Acids (8 Weeks)|8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) prior to low-dose endotoxin challenge
94751|NCT01813110|O1|Outcome|Placebo (8 Weeks)|8 weeks of placebo (olive oil) supplementation prior to low-dose endotoxin challenge
94752|NCT01813110|E2|Reported Event|Omega-3, Placebo|8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate) followed by 8 weeks of placebo (olive oil) supplementation
94753|NCT01813110|E1|Reported Event|Placebo, Omega-3|8 weeks of placebo (olive oil) supplementation followed by 8 weeks of omega-3 fatty acid supplementation (4 g prescription omega-3 fatty acid concentrate
94754|NCT01813019|B3|Baseline|Total|Total of all reporting groups
94755|NCT01813019|B2|Baseline|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
94756|NCT01813019|B1|Baseline|Placebo|Matching Placebo b.i.d. dosing
94757|NCT01813019|P2|Participant Flow|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
94758|NCT01813019|P1|Participant Flow|Placebo|Matching Placebo b.i.d. dosing
94759|NCT01813019|O2|Outcome|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
94760|NCT01813019|O1|Outcome|Placebo|Matching Placebo b.i.d. dosing
95463|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
94761|NCT01813019|O2|Outcome|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
94762|NCT01813019|O1|Outcome|Placebo|Matching Placebo b.i.d. dosing
94763|NCT01813019|E2|Reported Event|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
94764|NCT01813019|E1|Reported Event|Placebo|Matching Placebo b.i.d. dosing
94765|NCT01812837|B4|Baseline|Total|Total of all reporting groups
94766|NCT01812837|B3|Baseline|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94767|NCT01812837|B2|Baseline|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94768|NCT01812837|B1|Baseline|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94769|NCT01812837|P3|Participant Flow|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94770|NCT01812837|P2|Participant Flow|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94771|NCT01812837|P1|Participant Flow|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94772|NCT01812837|O3|Outcome|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94813|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94814|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
94773|NCT01812837|O2|Outcome|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94774|NCT01812837|O1|Outcome|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94775|NCT01812837|E3|Reported Event|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94776|NCT01812837|E2|Reported Event|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94777|NCT01812837|E1|Reported Event|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
94778|NCT01812707|B5|Baseline|Total|Total of all reporting groups
94779|NCT01812707|B4|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94780|NCT01812707|B3|Baseline|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94781|NCT01812707|B2|Baseline|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94782|NCT01812707|B1|Baseline|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
94783|NCT01812707|P4|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94784|NCT01812707|P3|Participant Flow|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94785|NCT01812707|P2|Participant Flow|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94786|NCT01812707|P1|Participant Flow|Placebo|Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
94787|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94788|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94789|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94790|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12 weeks in combination with atorvastatin stable dose.
94791|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94792|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94793|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94794|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
94795|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94796|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94797|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94798|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
94799|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94800|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94801|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94802|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
94803|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94804|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94805|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94806|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
94807|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94808|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94809|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94810|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
94811|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94815|NCT01812707|E4|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94816|NCT01812707|E3|Reported Event|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94817|NCT01812707|E2|Reported Event|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
94818|NCT01812707|E1|Reported Event|Placebo|Placebo Q2W for 12 weeks in combination with atorvastatin stable dose.
94819|NCT01812681|B3|Baseline|Total|Total of all reporting groups
94820|NCT01812681|B2|Baseline|Normal Vitamin D|The premature infants with normal vitamin D level
94821|NCT01812681|B1|Baseline|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
94822|NCT01812681|P2|Participant Flow|Normal Vitamin D|The premature infants with normal vitamin D level
94823|NCT01812681|P1|Participant Flow|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
94824|NCT01812681|O2|Outcome|Normal Vitamin D|The premature infants with normal vitamin D level
94825|NCT01812681|O1|Outcome|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
94826|NCT01812681|O2|Outcome|Normal Vitamin D|The premature infants with normal vitamin D level
94827|NCT01812681|O1|Outcome|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
94828|NCT01812681|E2|Reported Event|Normal Vitamin D|The premature infants with normal vitamin D level
94829|NCT01812681|E1|Reported Event|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
94830|NCT01812655|B4|Baseline|Total|Total of all reporting groups
94831|NCT01812655|B3|Baseline|Standard Care Provided by the Nurses|
94832|NCT01812655|B2|Baseline|Passive Distraction|watching a movie
94833|NCT01812655|B1|Baseline|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
94834|NCT01812655|P3|Participant Flow|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
94869|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
94835|NCT01812655|P2|Participant Flow|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
94836|NCT01812655|P1|Participant Flow|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
94837|NCT01812655|O3|Outcome|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
94838|NCT01812655|O2|Outcome|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
94839|NCT01812655|O1|Outcome|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
94840|NCT01812655|O3|Outcome|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
94841|NCT01812655|O2|Outcome|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
94842|NCT01812655|O1|Outcome|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
94843|NCT01812655|O3|Outcome|Standard Care Provided by the Nurses|
94844|NCT01812655|O2|Outcome|Passive Distraction|watching a movie
94845|NCT01812655|O1|Outcome|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
94846|NCT01812655|E3|Reported Event|UC Provided by the Nurses|
94847|NCT01812655|E2|Reported Event|Passive Distraction|watching a movie
94848|NCT01812655|E1|Reported Event|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
94849|NCT01812473|B3|Baseline|Total|Total of all reporting groups
94850|NCT01812473|B2|Baseline|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
94851|NCT01812473|B1|Baseline|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.
Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
94852|NCT01812473|P2|Participant Flow|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
94853|NCT01812473|P1|Participant Flow|Patients Admitted to the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.
Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
94854|NCT01812473|O2|Outcome|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
95327|NCT01809938|O1|Outcome|Black Tea|Black tea : 300ml of tea without milk
94855|NCT01812473|O1|Outcome|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.
Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
94856|NCT01812473|E2|Reported Event|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
94857|NCT01812473|E1|Reported Event|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.
Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
94858|NCT01812057|B3|Baseline|Total|Total of all reporting groups
94859|NCT01812057|B2|Baseline|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Placebo: Sodium Chloride 0.9% -5 ml"
94860|NCT01812057|B1|Baseline|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
94861|NCT01812057|P2|Participant Flow|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Placebo: Sodium Chloride 0.9% -5 ml"
94862|NCT01812057|P1|Participant Flow|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
94863|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Placebo: Sodium Chloride 0.9% -5 ml"
94864|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
94865|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
94866|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
94867|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
94868|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
94870|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
94871|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
94872|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
94873|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
94874|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
94875|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
94876|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
94877|NCT01812057|O2|Outcome|Negative MTS Score|Negative MTS score is defines as change of less than or equal to 1 in MTS scores between 1st tap and 11th tap.
94878|NCT01812057|O1|Outcome|Positive MTS Score|Positive MTS score is defined as change of >1 in MTS score between 1st tap and 11th tap of 180 gram von Frey filament.
94879|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
94880|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
94881|NCT01812057|O2|Outcome|Placebo|Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. ...
94882|NCT01812057|O1|Outcome|Dexamethasone|Dexamethasone 8 mg IV given intraoperatively as a one-time dose. ...
94883|NCT01812057|O2|Outcome|Negative MTS Score|Negative MTS score is defines as change of less than or equal to 1 in MTS scores between 1st tap and 11th tap.
94884|NCT01812057|O1|Outcome|Positive MTS Score|Positive MTS score is defined as change of >1 in MTS score between 1st tap and 11th tap of 180 gram von Frey filament.
94885|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Placebo: Sodium Chloride 0.9% -5 ml"
94886|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
94887|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Placebo: Sodium Chloride 0.9% -5 ml"
94888|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
94889|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Placebo: Sodium Chloride 0.9% -5 ml"
94890|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
94891|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Placebo: Sodium Chloride 0.9% -5 ml"
94892|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
94893|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Placebo: Sodium Chloride 0.9% -5 ml"
94894|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
94895|NCT01812057|O2|Outcome|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Placebo: Sodium Chloride 0.9% -5 ml"
94896|NCT01812057|O1|Outcome|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
94897|NCT01812057|E2|Reported Event|Placebo|"Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Placebo: Sodium Chloride 0.9% -5 ml"
94898|NCT01812057|E1|Reported Event|Dexamethasone|"Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)"
94899|NCT01812044|B4|Baseline|Total|Total of all reporting groups
94900|NCT01812044|B3|Baseline|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline"
94901|NCT01812044|B2|Baseline|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
subtenons control - 0.5 cc of Normal Saline"
94902|NCT01812044|B1|Baseline|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical control - 0.5 cc of Hypromellose 0.3% gel"
94903|NCT01812044|P3|Participant Flow|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline"
94904|NCT01812044|P2|Participant Flow|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
subtenons control - 0.5 cc of Normal Saline"
94905|NCT01812044|P1|Participant Flow|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical control - 0.5 cc of Hypromellose 0.3% gel"
94975|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94906|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline"
94907|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
subtenons control - 0.5 cc of Normal Saline"
94908|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical control - 0.5 cc of Hypromellose 0.3% gel"
94909|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline"
94910|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
subtenons control - 0.5 cc of Normal Saline"
94911|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical control - 0.5 cc of Hypromellose 0.3% gel"
94912|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline"
94913|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
subtenons control - 0.5 cc of Normal Saline"
94914|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical control - 0.5 cc of Hypromellose 0.3% gel"
94915|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline"
94916|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
subtenons control - 0.5 cc of Normal Saline"
94917|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical control - 0.5 cc of Hypromellose 0.3% gel"
94918|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline"
94919|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
subtenons control - 0.5 cc of Normal Saline"
94920|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical control - 0.5 cc of Hypromellose 0.3% gel"
94921|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline"
94922|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
subtenons control - 0.5 cc of Normal Saline"
94976|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: low dose of Empagliflozin oral administration
Metformin: oral administration"
95523|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
94923|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical control - 0.5 cc of Hypromellose 0.3% gel"
94924|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline"
94925|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
subtenons control - 0.5 cc of Normal Saline"
94926|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical control - 0.5 cc of Hypromellose 0.3% gel"
94927|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline"
94928|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
subtenons control - 0.5 cc of Normal Saline"
94929|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical control - 0.5 cc of Hypromellose 0.3% gel"
94930|NCT01812044|E3|Reported Event|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline"
94931|NCT01812044|E2|Reported Event|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
subtenons control - 0.5 cc of Normal Saline"
94932|NCT01812044|E1|Reported Event|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical control - 0.5 cc of Hypromellose 0.3% gel"
94933|NCT01811953|B7|Baseline|Total|Total of all reporting groups
94934|NCT01811953|B6|Baseline|Low Dose Emp: Emp+Met / Emp/Met|"free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions
Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
94935|NCT01811953|B5|Baseline|Low Dose Emp: Emp/Met / Emp+Met|"fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions
Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
94936|NCT01811953|B4|Baseline|Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted|"free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions
Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
94937|NCT01811953|B3|Baseline|Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed|"free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions
Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
94938|NCT01811953|B2|Baseline|Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted|"fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions
Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
94939|NCT01811953|B1|Baseline|Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed|"fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions
Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
94940|NCT01811953|P6|Participant Flow|Low Dose Emp: Emp+Met / Emp/Met|"free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions
Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
94941|NCT01811953|P5|Participant Flow|Low Dose Emp: Emp/Met / Emp+Met|"fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions
Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
94942|NCT01811953|P4|Participant Flow|Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted|"free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions
Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
95064|NCT01811485|E4|Reported Event|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
94943|NCT01811953|P3|Participant Flow|Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed|"free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions
Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
94944|NCT01811953|P2|Participant Flow|Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted|"fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions
Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
94945|NCT01811953|P1|Participant Flow|Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed|"fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions
Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
94946|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: low dose of Empagliflozin oral administration
Metformin: oral administration"
94947|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: low dose of Empagliflozin"
94948|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94949|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94950|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94951|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94952|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: low dose of Empagliflozin oral administration
Metformin: oral administration"
94953|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: low dose of Empagliflozin"
94954|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94955|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94956|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94957|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94958|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: low dose of Empagliflozin oral administration
Metformin: oral administration"
94959|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: low dose of Empagliflozin"
94960|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94961|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94962|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94963|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94964|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: low dose of Empagliflozin oral administration
Metformin: oral administration"
94965|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: low dose of Empagliflozin"
94966|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94967|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94968|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94969|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94970|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: low dose of Empagliflozin oral administration
Metformin: oral administration"
94971|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: low dose of Empagliflozin"
94972|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94973|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94974|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
95454|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
94977|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: low dose of Empagliflozin"
94978|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94979|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94980|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94981|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94982|NCT01811953|E6|Reported Event|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: low dose of Empagliflozin oral administration
Metformin: oral administration"
94983|NCT01811953|E5|Reported Event|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: low dose of Empagliflozin"
94984|NCT01811953|E4|Reported Event|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94985|NCT01811953|E3|Reported Event|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration"
94986|NCT01811953|E2|Reported Event|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94987|NCT01811953|E1|Reported Event|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
94988|NCT01811732|B3|Baseline|Total|Total of all reporting groups
94989|NCT01811732|B2|Baseline|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses
Vancomycin: Vancomycin
Aztreonam: Aztreonam
Placebo: Placebo"
94990|NCT01811732|B1|Baseline|Delafloxacin + Placebo|"300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses
Delafloxacin: Delafloxacin
Placebo: Placebo"
94991|NCT01811732|P2|Participant Flow|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses
Vancomycin: Vancomycin
Aztreonam: Aztreonam
Placebo: Placebo"
94992|NCT01811732|P1|Participant Flow|Delafloxacin Plus Placebo|"300 mg IV every 12 hours, for a minimum of 10 and up to a maximum of 28 doses
Delafloxacin: Delafloxacin
Placebo: Placebo"
94993|NCT01811732|O2|Outcome|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses
Vancomycin: Vancomycin
Aztreonam: Aztreonam
Placebo: Placebo"
94994|NCT01811732|O1|Outcome|Delafloxacin Plus Placebo|"300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses
Delafloxacin: Delafloxacin
Placebo: Placebo"
94995|NCT01811732|O2|Outcome|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses
Vancomycin: Vancomycin
Aztreonam: Aztreonam
Placebo: Placebo"
94996|NCT01811732|O1|Outcome|Delafloxacin Plus Placebo|"300mg iv every 12 hours, for a minimum of 10 and up to a maximum of 28 doses
Delafloxacin: Delafloxacin
Placebo: Placebo"
94997|NCT01811732|O2|Outcome|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses
Vancomycin: Vancomycin
Aztreonam: Aztreonam
Placebo: Placebo"
94998|NCT01811732|O1|Outcome|Delafloxacin Plus Placebo|"300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses
Delafloxacin: Delafloxacin
Placebo: Placebo"
94999|NCT01811732|E2|Reported Event|Vancomycin Plus Aztreonam + Placebo|"Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses
Vancomycin: Vancomycin
Aztreonam: Aztreonam
Placebo: Placebo"
95000|NCT01811732|E1|Reported Event|Delafloxacin Plus Placebo|"300mg iv every 12 hours, for a minimum of 10 and up to a maximum of 28 doses
Delafloxacin: Delafloxacin
Placebo: Placebo"
95001|NCT01811706|B1|Baseline|All Study Participants|
95002|NCT01811706|P2|Participant Flow|Placebo, Then Dalfampridine|"Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks.
Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period
Placebo: Placebo will be administered orally every 12 hours, for a 4 week period."
95003|NCT01811706|P1|Participant Flow|Dalfampridine and Then Placebo|"Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period.
Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period
Placebo: Placebo will be administered orally every 12 hours, for a 4 week period."
95004|NCT01811706|O2|Outcome|Placebo|Participant who received Placebo orally every 12 hours for a 4 week period.
95005|NCT01811706|O1|Outcome|Dalfampridine|Participant who received Dalfampridine at an oral dose of 10mg every 12 hours for 4 weeks period.
95006|NCT01811706|O2|Outcome|Placebo|Participant received Placebo orally every 12 hours for a 4 week period.
95007|NCT01811706|O1|Outcome|Dalfampridine|Participant received Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks period.
95008|NCT01811706|O2|Outcome|Placebo|Participant who received Placebo orally every 12 hours for a 4 week period.
95009|NCT01811706|O1|Outcome|Dalfampridine|Participant who received Dalfampridine at an oral dose of 10mg every 12 hours for 4 weeks period.
95010|NCT01811706|E2|Reported Event|Placebo|Participant received Placebo orally every 12 hours for a 4 week period.
95011|NCT01811706|E1|Reported Event|Dalfampridine|Participant received Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks period.
95063|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
95012|NCT01811680|B1|Baseline|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.
Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
95013|NCT01811680|P1|Participant Flow|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.
Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
95014|NCT01811680|O1|Outcome|Supervised Treadmill Training|Supervised treadmill training on variable sensing treadmill.
95015|NCT01811680|O1|Outcome|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.
Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
95016|NCT01811680|E1|Reported Event|Supervised Treadmill Training|Research Intervention: Supervised treadmill training on variable sensing treadmill.
95017|NCT01811563|B3|Baseline|Total|Total of all reporting groups
95018|NCT01811563|B2|Baseline|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95019|NCT01811563|B1|Baseline|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95020|NCT01811563|P2|Participant Flow|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95021|NCT01811563|P1|Participant Flow|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95022|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95023|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95024|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95025|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95026|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95027|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95028|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95029|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95030|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95031|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95032|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95033|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95034|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95035|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95036|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95037|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95038|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95039|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95040|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95041|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95042|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95043|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95044|NCT01811563|E2|Reported Event|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer"
95045|NCT01811563|E1|Reported Event|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker"
95046|NCT01811485|B4|Baseline|Total|Total of all reporting groups
95047|NCT01811485|B3|Baseline|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
95048|NCT01811485|B2|Baseline|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
95049|NCT01811485|B1|Baseline|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
95050|NCT01811485|P3|Participant Flow|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
95051|NCT01811485|P2|Participant Flow|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
95052|NCT01811485|P1|Participant Flow|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
95053|NCT01811485|O3|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
95054|NCT01811485|O2|Outcome|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
95055|NCT01811485|O1|Outcome|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
95056|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
95057|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
95058|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
95059|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
95060|NCT01811485|O2|Outcome|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
95061|NCT01811485|O1|Outcome|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
95062|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
95065|NCT01811485|E3|Reported Event|LMF237 50/500mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
95066|NCT01811485|E2|Reported Event|LMF237 50/250mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
95067|NCT01811485|E1|Reported Event|POOLED LMF237|All patients who has received LMF237
95068|NCT01811472|B4|Baseline|Total|Total of all reporting groups
95069|NCT01811472|B3|Baseline|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95070|NCT01811472|B2|Baseline|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95071|NCT01811472|B1|Baseline|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95072|NCT01811472|P3|Participant Flow|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95073|NCT01811472|P2|Participant Flow|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95074|NCT01811472|P1|Participant Flow|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95075|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95076|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95077|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95078|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95079|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95080|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95081|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95082|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95083|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95117|NCT01811472|E1|Reported Event|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95084|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95085|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95086|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95087|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95088|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95089|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95090|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95091|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95092|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95093|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95094|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95095|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95096|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95097|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95098|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95099|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95118|NCT01811355|B1|Baseline|Total Subjects Enrolled|A total of 23 subjects were enrolled. 11 were randomized to receive study drug first, followed by placebo. 12 subjects received placebo first and study drug second. Overall participant characteristics are displayed in the baseline table.
95524|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
95100|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95101|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95102|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95103|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95104|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95105|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95106|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95107|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95108|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95109|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95110|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95111|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95112|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95113|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95114|NCT01811472|E4|Reported Event|Pooled Pradigastat (LCQ908)|This arm included all patients randomized to pradigastat (LCQ908) 5mg/10 mg and pradigastat (LCQ908)10mg/20 mg
95115|NCT01811472|E3|Reported Event|Pradigastat (LCQ908) 10mg/20 mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95116|NCT01811472|E2|Reported Event|Pradigastat (LCQ908) 5mg /10 mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
95119|NCT01811355|P2|Participant Flow|Placebo First/Mexiletine Second|"Placebo, capsule, PO BID, 14 days
Mexiletine, capsule, 150mg, PO BID, 14 days"
95120|NCT01811355|P1|Participant Flow|Mexiletine First/Placebo Second|"Mexiletine, capsule, 150mg, PO BID, 14 days
Placebo, capsule, PO BID, 14 days"
95121|NCT01811355|O2|Outcome|Placebo First|"Placebo, capsule, PO BID, 14 days
Placebo: Placebo"
95122|NCT01811355|O1|Outcome|Mexiletine First|"Mexiletine, capsule, 150mg, PO BID, 14 days
Mexiletine: Sodium channel blocker"
95123|NCT01811355|O2|Outcome|Placebo First/Mexiletine Second|"Placebo, capsule, PO BID, 14 days
Mexiletine, capsule, 150mg, PO BID, 14 days"
95124|NCT01811355|O1|Outcome|Mexiletine First/Placebo Second|"Mexiletine, capsule, 150mg, PO BID, 14 days
Placebo, capsule, PO BID, 14 days"
95125|NCT01811355|E2|Reported Event|Placebo|"Placebo, capsule, PO BID, 14 days
Placebo: Placebo"
95126|NCT01811355|E1|Reported Event|Mexiletine|"Mexiletine, capsule, 150mg, PO BID, 14 days
Mexiletine: Sodium channel blocker"
95127|NCT01811303|B1|Baseline|D-fagomine (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water vs placebo.
95128|NCT01811303|P4|Participant Flow|Treatment, Placebo, Treatment, Placebo|The subjects receive placebo or treatment in each intervention alternatively, starting with treatment.
95129|NCT01811303|P3|Participant Flow|Placebo, Treatment, Placebo, Treatment|The subjects receive placebo or treatment in each intervention alternatively, starting with placebo.
95130|NCT01811303|P2|Participant Flow|Treatment, Treatment, Placebo, Placebo|The subjects receive treatment in the first two interventions
95131|NCT01811303|P1|Participant Flow|Placebo, Placebo, Treatment, Treatment|The subjects receive placebo in the first two interventions.
95132|NCT01811303|O2|Outcome|Control|Determination of glucose Cmax over the Baseline of the control: sucrose 50 g + 200 ml water. Blood glucose concentration expressed in mmol/l.
95133|NCT01811303|O1|Outcome|D-fagomine|Determination of glucose Cmax over the Baseline of the treatment: sucrose 50 g + 200 ml water + 40 mg D-fagomine. Blood glucose concentration expressed in mmol/l.
95134|NCT01811303|O2|Outcome|Change D-fagomine/Control AUC at 120 Min|Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 120 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
95135|NCT01811303|O1|Outcome|Change D-fagomine/Control AUC at 60 Min|Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 60 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
95136|NCT01811303|E2|Reported Event|Placebo - Control (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g sucrose in 200 ml water (without d-fagomine)
95137|NCT01811303|E1|Reported Event|D-fagomine (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water.
95138|NCT01811238|B1|Baseline|Oxycodone/Naloxone|"Single-arm study
Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
95139|NCT01811238|P1|Participant Flow|Oxycodone/Naloxone|"Single-arm study
Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
95140|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study
Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
95141|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study
Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
95142|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study
Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
95143|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study
Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
95144|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study
Oxycodone/naloxone: Targin 5mg, 10mg, 20mg up to 40mg b.i.d"
95145|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study
Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
95146|NCT01811238|E1|Reported Event|Oxycodone/Naloxone|"Single-arm study
Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
95147|NCT01811186|B3|Baseline|Total|Total of all reporting groups
95148|NCT01811186|B2|Baseline|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95149|NCT01811186|B1|Baseline|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95150|NCT01811186|P2|Participant Flow|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95151|NCT01811186|P1|Participant Flow|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95152|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95153|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95154|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95155|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
95156|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95157|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
95158|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95159|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
95160|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95525|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
95161|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
95162|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95163|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
95164|NCT01811186|E2|Reported Event|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95165|NCT01811186|E1|Reported Event|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
95166|NCT01810952|B3|Baseline|Total|Total of all reporting groups
95167|NCT01810952|B2|Baseline|Glargine/Lispro/NPH Insulin Arm|"The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
95168|NCT01810952|B1|Baseline|Glargine/Lispro Insulin Arm|"The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
95169|NCT01810952|P2|Participant Flow|Glargine/Lispro/NPH Insulin|"The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
95170|NCT01810952|P1|Participant Flow|Glargine/Lispro Insulin|"The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
95171|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|
95172|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|
95173|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|
95174|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|
95175|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|Insulin (units)/kg body weight
95176|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|Insulin (units)/kg body weight
95177|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|Last Full Day of Protocol
95178|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|Last Full Day of Protocol
95205|NCT01810692|P2|Participant Flow|Hirobriz/Onbrez/Oslif Breezhaler|Patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
95179|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|"Basal and meal coverage for G/L/N Arm is similar to that in the GL Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose will be 0.4 units/kg per day.
Glargine/Lispro/NPH insulin: The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose will be 0.4 units/kg per day."
95180|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|"The G/L Arm will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting coverage dose will be 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL."
95181|NCT01810952|E2|Reported Event|Glargine/Lispro/NPH Insulin Arm|"The basal and prandial doses of glargine and lispro were similar to those in the G/L/N Protocol. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
95182|NCT01810952|E1|Reported Event|Glargine/Lispro Insulin Arm|"The G/L Arm received 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
95183|NCT01810939|B1|Baseline|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
95184|NCT01810939|P3|Participant Flow|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
95185|NCT01810939|P2|Participant Flow|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
95186|NCT01810939|P1|Participant Flow|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
95187|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
95188|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
95189|NCT01810939|O1|Outcome|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks. The dose of patiromer could be titrated based on participant's serum potassium response.
95190|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
95191|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
95192|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
95193|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
95194|NCT01810939|O1|Outcome|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
95195|NCT01810939|E3|Reported Event|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
95196|NCT01810939|E2|Reported Event|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
95197|NCT01810939|E1|Reported Event|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
95198|NCT01810783|B1|Baseline|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
95199|NCT01810783|P1|Participant Flow|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
95200|NCT01810783|O1|Outcome|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
95201|NCT01810783|E1|Reported Event|Brexpiprazole|210 were enrolled, only 209 patients were treated with brexpiprazole
95202|NCT01810692|B3|Baseline|Total|Total of all reporting groups
95203|NCT01810692|B2|Baseline|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
95204|NCT01810692|B1|Baseline|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
95206|NCT01810692|P1|Participant Flow|Spiriva Respimat|Patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
95207|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
95208|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
95209|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
95210|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
95211|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
95212|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
95213|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
95214|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
95215|NCT01810692|E2|Reported Event|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
95216|NCT01810692|E1|Reported Event|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
95217|NCT01810666|B1|Baseline|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
95263|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95218|NCT01810666|P1|Participant Flow|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
95219|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
95220|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
95221|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
95222|NCT01810666|E1|Reported Event|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
95223|NCT01810380|B4|Baseline|Total|Total of all reporting groups
95224|NCT01810380|B3|Baseline|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95225|NCT01810380|B2|Baseline|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95226|NCT01810380|B1|Baseline|Placebo|Placebo: Once daily as tablets and capsules, orally
95227|NCT01810380|P3|Participant Flow|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95228|NCT01810380|P2|Participant Flow|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95229|NCT01810380|P1|Participant Flow|Placebo|Placebo: Once daily as tablets and capsules, orally
95230|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95231|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95232|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95233|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95234|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95235|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95236|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95237|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95238|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95239|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95242|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95243|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95244|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95245|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95246|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95247|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95248|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95249|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95250|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95251|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95252|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95253|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95254|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95255|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95256|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95257|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95258|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95259|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95260|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95261|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95262|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95264|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95266|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95267|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95268|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95269|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95270|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95271|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95272|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95273|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95274|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95275|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95276|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95277|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95278|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95279|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95280|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95281|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95282|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95283|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
95284|NCT01810380|E3|Reported Event|Quetiapine|"Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
95285|NCT01810380|E2|Reported Event|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
95286|NCT01810380|E1|Reported Event|Placebo|Placebo: Once daily as tablets and capsules, orally
95287|NCT01810302|B3|Baseline|Total|Total of all reporting groups
95288|NCT01810302|B2|Baseline|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
95289|NCT01810302|B1|Baseline|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
95290|NCT01810302|P2|Participant Flow|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
95291|NCT01810302|P1|Participant Flow|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
95292|NCT01810302|O2|Outcome|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
95328|NCT01809938|O2|Outcome|Tea With Milk|Tea with milk : 250ml of black tea with 50ml of full fat milk
95329|NCT01809938|O1|Outcome|Black Tea|Black tea : 300ml of tea without milk
95293|NCT01810302|O1|Outcome|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
95294|NCT01810302|O2|Outcome|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
95295|NCT01810302|O1|Outcome|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
95296|NCT01810302|E2|Reported Event|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
95297|NCT01810302|E1|Reported Event|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
95298|NCT01810289|B3|Baseline|Total|Total of all reporting groups
95299|NCT01810289|B2|Baseline|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
95300|NCT01810289|B1|Baseline|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
95301|NCT01810289|P2|Participant Flow|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
95302|NCT01810289|P1|Participant Flow|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
95303|NCT01810289|O2|Outcome|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
95304|NCT01810289|O1|Outcome|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
95305|NCT01810289|E2|Reported Event|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
95306|NCT01810289|E1|Reported Event|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
95307|NCT01810263|B3|Baseline|Total|Total of all reporting groups
95308|NCT01810263|B2|Baseline|Control|no intervention
95309|NCT01810263|B1|Baseline|High Protein Supplement|high protein supplement given
95310|NCT01810263|P2|Participant Flow|Control|Patients in the both groups keep on routine diet in the hospital. No additional calories are provided.
95311|NCT01810263|P1|Participant Flow|High Protein Supplement|"Patients in the both groups keep on routine diet in the hospital All the patients in the High Protein Supplement group were provided additional calories of Nucare(High protein fluid diet, 200kcal/200ml/1 can. Dasang, Seoul, Korea) three times a day.
(As a result, additional calories are 600kcal a day)"
95312|NCT01810263|O2|Outcome|Control|no intervention
95313|NCT01810263|O1|Outcome|High Protein Supplement|high protein supplement given
95314|NCT01810263|E2|Reported Event|Control|no intervention
95315|NCT01810263|E1|Reported Event|High Protein Supplement|high protein supplement given
95316|NCT01810042|B1|Baseline|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.
intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
95317|NCT01810042|P1|Participant Flow|Ranibizumab|"Ranibizumab is injected monthly 3 times then pro re nata (PRN) to 6 months.
intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
95318|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.
intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
95319|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.
intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
95320|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.
intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
95321|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.
intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
95322|NCT01810042|E1|Reported Event|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.
intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
95323|NCT01809938|B1|Baseline|Entire Study Population|Includes all participants in this crossover trial
95324|NCT01809938|P2|Participant Flow|Tea With Milk First Then Black Tea|Effects on gastric emptying of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed then after a period of not less than 24 hours the effects of Black tea (300ml of tea without milk) were assessed.
95325|NCT01809938|P1|Participant Flow|Black Tea First, Then Tea With Milk|Effects on gastric emptying of Black tea (300ml of tea without milk) were assessed then after a period of not less than 24 hours the effects of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed
95330|NCT01809938|E1|Reported Event|Entire Study Population|Includes all participants in this crossover trial
95331|NCT01809834|B1|Baseline|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95332|NCT01809834|P1|Participant Flow|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simulataneously
Etafilcon A
Stenfilcon A"
95333|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95334|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95335|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95336|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95337|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95338|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95339|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95340|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95341|NCT01809834|O1|Outcome|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95342|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95455|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95343|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95344|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95345|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95346|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95347|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95348|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95349|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95350|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95351|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95352|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95353|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95354|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95355|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A"
95356|NCT01809834|E1|Reported Event|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other
Etafilcon A
Stenfilcon A"
95357|NCT01809639|B3|Baseline|Total|Total of all reporting groups
95358|NCT01809639|B2|Baseline|Placebo|Placebo: Standard placebo for 5 days
95359|NCT01809639|B1|Baseline|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five
Progesterone"
95360|NCT01809639|P2|Participant Flow|Placebo|Placebo: Standard placebo for 5 days
95361|NCT01809639|P1|Participant Flow|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five
Progesterone"
95362|NCT01809639|O2|Outcome|Placebo|Placebo: Standard placebo for 5 days
95363|NCT01809639|O1|Outcome|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five
Progesterone"
95364|NCT01809639|E2|Reported Event|Placebo|Placebo: Standard placebo for 5 days
95365|NCT01809639|E1|Reported Event|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five
Progesterone"
95366|NCT01809327|B6|Baseline|Total|Total of all reporting groups
95367|NCT01809327|B5|Baseline|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95368|NCT01809327|B4|Baseline|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95500|NCT01809197|B2|Baseline|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
95369|NCT01809327|B3|Baseline|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95370|NCT01809327|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95371|NCT01809327|B1|Baseline|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
95372|NCT01809327|P5|Participant Flow|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95373|NCT01809327|P4|Participant Flow|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95374|NCT01809327|P3|Participant Flow|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95375|NCT01809327|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95376|NCT01809327|P1|Participant Flow|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
95456|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
95377|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95378|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95379|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95380|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95381|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
95382|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95383|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95384|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95385|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95386|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
95387|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95388|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95389|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95390|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95391|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
95392|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95393|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95394|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95395|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95396|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
95397|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95398|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95457|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
95458|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
95399|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95400|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95401|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
95402|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95403|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95404|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95405|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95406|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
95407|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95408|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95409|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95410|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95411|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
95412|NCT01809327|E5|Reported Event|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95413|NCT01809327|E4|Reported Event|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
95414|NCT01809327|E3|Reported Event|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95415|NCT01809327|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
95416|NCT01809327|E1|Reported Event|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
95417|NCT01809314|B1|Baseline|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
95418|NCT01809314|P1|Participant Flow|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
95419|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
95459|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95460|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95526|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
95420|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
95421|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
95422|NCT01809314|E1|Reported Event|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
95423|NCT01809262|B1|Baseline|Study Total|Total number of patients treated in the study. This was a double-blind, 5-period crossover trial. Each of the 36 patients received placebo and 4 single doses of Olodaterol (Olo) (2 microgram (mcg), 5 mcg, 10 mcg, 20mcg) separated by a wash-out period of at least 14 days.
95424|NCT01809262|P10|Participant Flow|Olo 20mcg / Olo 10mcg / Placebo / Olo 5mcg / Olo 2mcg|Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, matching Placebo in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
95425|NCT01809262|P9|Participant Flow|Olo 20mcg / Placebo / Olo 10mcg / Olo 2mcg / Olo 5mcg|Patients were administered Olodaterol 20 mcg qd in the first period, matching Placebo in the second period, Olodaterol 10 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
95426|NCT01809262|P8|Participant Flow|Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
95427|NCT01809262|P7|Participant Flow|Olo 10mcg / Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
95428|NCT01809262|P6|Participant Flow|Olo 5mcg / Olo 10mcg / Olo 2mcg / Olo 20mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
95429|NCT01809262|P5|Participant Flow|Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
95430|NCT01809262|P4|Participant Flow|Olo 2mcg / Placebo / Olo 5mcg / Olo 20mcg / Olo 10mcg|Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
95431|NCT01809262|P3|Participant Flow|Olo 2mcg / Olo 5mcg / Placebo / Olo 10mcg / Olo 20mcg|Patients were administered Olodaterol 2 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
95432|NCT01809262|P2|Participant Flow|Placebo / Olo 20mcg / Olo 2mcg / Olo 10mcg / Olo 5mcg|Patients were administered matching Placebo in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
95433|NCT01809262|P1|Participant Flow|Placebo / Olo 2mcg / Olo 20mcg / Olo 5mcg / Olo 10mcg|Patients were administered matching Placebo in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
95434|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95435|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95436|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
95437|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
95438|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
95439|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95440|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95441|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
95442|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
95443|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
95444|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95445|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95446|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
95447|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
95448|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
95449|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95450|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95464|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95465|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95466|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
95467|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
95468|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
95469|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95470|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95471|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
95472|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
95473|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
95474|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95475|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95476|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
95477|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
95478|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
95479|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95480|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95481|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
95482|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
95483|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
95484|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95485|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95486|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
95487|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
95488|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
95489|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95490|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95491|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
95492|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
95493|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
95494|NCT01809262|E5|Reported Event|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
95495|NCT01809262|E4|Reported Event|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
95496|NCT01809262|E3|Reported Event|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
95497|NCT01809262|E2|Reported Event|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
95498|NCT01809262|E1|Reported Event|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
95499|NCT01809197|B3|Baseline|Total|Total of all reporting groups
96179|NCT01806857|E2|Reported Event|Matching Placebo|Includes all subjects that took matching placebo
95501|NCT01809197|B1|Baseline|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
95502|NCT01809197|P2|Participant Flow|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
95503|NCT01809197|P1|Participant Flow|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
95504|NCT01809197|O2|Outcome|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
95505|NCT01809197|O1|Outcome|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
95506|NCT01809197|E2|Reported Event|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
95507|NCT01809197|E1|Reported Event|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
95508|NCT01809106|B5|Baseline|Total|Total of all reporting groups
95509|NCT01809106|B4|Baseline|Fentanyl|Fentanyl: 25 microg/h
95510|NCT01809106|B3|Baseline|Buprenorphine|Buprenorphine: 35 microg/h
95511|NCT01809106|B2|Baseline|Oxycodone|Oxycodone: 40 mg /24 ore
95512|NCT01809106|B1|Baseline|Morphine|Morphine: 60 mg /24 ore
95513|NCT01809106|P4|Participant Flow|Fentanyl|Fentanyl: 25 microg/h
95514|NCT01809106|P3|Participant Flow|Buprenorphine|Buprenorphine: 35 microg/h
95515|NCT01809106|P2|Participant Flow|Oxycodone|Oxycodone: 40 mg /24 ore
95516|NCT01809106|P1|Participant Flow|Morphine|Morphine: 60 mg /24 ore
95517|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
95518|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
95519|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
95520|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
95521|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
95522|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
95530|NCT01809106|E3|Reported Event|Buprenorphine|Buprenorphine: 35 microg/h
95531|NCT01809106|E2|Reported Event|Oxycodone|Oxycodone: 40 mg /24 ore
95532|NCT01809106|E1|Reported Event|Morphine|Morphine: 60 mg /24 ore
95533|NCT01809054|B3|Baseline|Total|Total of all reporting groups
95534|NCT01809054|B2|Baseline|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Aspirin"
95535|NCT01809054|B1|Baseline|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Arixtra
Aspirin"
95536|NCT01809054|P2|Participant Flow|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Aspirin"
95537|NCT01809054|P1|Participant Flow|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Arixtra
Aspirin"
95538|NCT01809054|O2|Outcome|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Aspirin"
95539|NCT01809054|O1|Outcome|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Arixtra
Aspirin"
95540|NCT01809054|O2|Outcome|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Aspirin"
95541|NCT01809054|O1|Outcome|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Arixtra
Aspirin"
95542|NCT01809054|E2|Reported Event|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Aspirin"
95543|NCT01809054|E1|Reported Event|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Arixtra
Aspirin"
95544|NCT01808963|B1|Baseline|Study Group|Respiratory Heat Loss Measured in Joules Per Minute
95545|NCT01808963|P1|Participant Flow|Study Group|Patients undergoing elective surgery requiring endotracheal intubation for anesthesia.
95546|NCT01808963|O1|Outcome|Study Group|Joules per minute
95547|NCT01808963|E1|Reported Event|Study Group|Respiratory Heat Loss Measured in Joules Per Minute
95548|NCT01808950|B4|Baseline|Total|Total of all reporting groups
95549|NCT01808950|B3|Baseline|0.06% Resiquimod Gel - C|"100 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
0.06% Resiquimod Gel - C"
95550|NCT01808950|B2|Baseline|0.06% Resiquimod Gel - B|"100 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - B"
95551|NCT01808950|B1|Baseline|0.06% Resiquimod Gel - A|"60 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - A"
95579|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95552|NCT01808950|P3|Participant Flow|0.06% Resiquimod Gel - C|"100 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
0.06% Resiquimod Gel - C"
95553|NCT01808950|P2|Participant Flow|0.06% Resiquimod Gel - B|"100 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - B"
95554|NCT01808950|P1|Participant Flow|0.06% Resiquimod Gel - A|"60 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - A"
95555|NCT01808950|O3|Outcome|0.06% Resiquimod Gel - C|"100 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
0.06% Resiquimod Gel - C: shave biopsy of BCC followed by single 100mg dose"
95556|NCT01808950|O2|Outcome|0.06% Resiquimod Gel - B|"100 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation"
95557|NCT01808950|O1|Outcome|0.06% Resiquimod Gel - A|"60 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation"
95558|NCT01808950|O3|Outcome|0.06% Resiquimod Gel - C|"100 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
0.06% Resiquimod Gel - C"
95559|NCT01808950|O2|Outcome|0.06% Resiquimod Gel - B|"100 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - B"
95560|NCT01808950|O1|Outcome|0.06% Resiquimod Gel - A|"60 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - A"
96020|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95561|NCT01808950|E3|Reported Event|0.06% Resiquimod Gel - C|"100 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
0.06% Resiquimod Gel - C"
95562|NCT01808950|E2|Reported Event|0.06% Resiquimod Gel - B|"100 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - B"
95563|NCT01808950|E1|Reported Event|0.06% Resiquimod Gel - A|"60 mg gel
Once daily prior to normal sleeping hours
5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - A"
95564|NCT01808755|B1|Baseline|All Study Participamts|D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
95565|NCT01808755|P2|Participant Flow|Trimethoprim/Sulfamethoxazole First, Then D Mannose|Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks
95566|NCT01808755|P1|Participant Flow|D Mannose First, Then Trimethoprim/Sulfamethoxazole|D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days
95567|NCT01808755|O2|Outcome|Trimethoprim /Sulfamethoxazole First, Then D Mannose|trimethoprim/sulfametossazole 160/800 mg for 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks
95568|NCT01808755|O1|Outcome|D Mannose First, Then Trimethoprim /Sulfamethoxazole|1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
95569|NCT01808755|E1|Reported Event|D Mannose Versus Antibiotic|"1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks
D Mannose : D Mannose versus oral antibiotic
Antibiotic : length of treatment: 5-7 days"
95570|NCT01808651|B4|Baseline|Total|Total of all reporting groups
95571|NCT01808651|B3|Baseline|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95572|NCT01808651|B2|Baseline|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95573|NCT01808651|B1|Baseline|PLA/FLX (Placebo/Fluoxetine)|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95574|NCT01808651|P3|Participant Flow|FLX40/FLX|"Period 1: Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.
Period 2: 2-week observation phase following discontinuation of fluoxetine."
95575|NCT01808651|P2|Participant Flow|FLX20/FLX|"Period 1: Participants randomized to fluoxetine 20 mg /day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.
Period 2: 2-week observation phase following discontinuation of fluoxetine."
95576|NCT01808651|P1|Participant Flow|PLA/FLX|"Period 1: Participants (Pts) randomized to placebo in Study B1Y-JE-HCLV transitioned to fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.
Period 2: 2-week observation phase following discontinuation (DC'd) of fluoxetine."
95577|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95578|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95580|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95581|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95582|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95583|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95584|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95585|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95586|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95587|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95588|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95589|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95590|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95591|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95592|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95593|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95594|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95595|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95596|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95597|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95598|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95599|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95600|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95601|NCT01808651|E6|Reported Event|Study Period 2 Discontinued From FLX40/FLX|Participants in the FLX40/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
95602|NCT01808651|E5|Reported Event|Study Period 2 Discontinued From FLX20/FLX|Participants in the FLX20/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
95603|NCT01808651|E4|Reported Event|Study Period 2 Discontinued From PLA/FLX|Participants in the PLA/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2,
95604|NCT01808651|E3|Reported Event|Study Period 1 FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95605|NCT01808651|E2|Reported Event|Study Period 1 FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95606|NCT01808651|E1|Reported Event|Study Period 1 PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
95607|NCT01808612|B4|Baseline|Total|Total of all reporting groups
95608|NCT01808612|B3|Baseline|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
95609|NCT01808612|B2|Baseline|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95610|NCT01808612|B1|Baseline|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95611|NCT01808612|P3|Participant Flow|Placebo|"Treatment Period: placebo (capsules) administered orally, once daily, for 6 weeks
Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
95612|NCT01808612|P2|Participant Flow|40 mg Fluoxetine|"Treatment Period: 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
95613|NCT01808612|P1|Participant Flow|20 mg Fluoxetine|"Treatment Period: 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks
Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
95614|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
95615|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95616|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95617|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
95618|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95619|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95620|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
95621|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95622|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95623|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
95624|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95625|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95626|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
95627|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95628|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95629|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
95630|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95631|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95632|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
95633|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95634|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
95635|NCT01808612|E6|Reported Event|Placebo (Discontinuation From 40 mg Fluoxetine)|AEs which occurred during the Discontinuation Period for participants who received 40 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
95636|NCT01808612|E5|Reported Event|Placebo (Discontinuation From 20 mg Fluoxetine)|AEs which occurred during the Discontinuation Period for participants who received 20 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
95637|NCT01808612|E4|Reported Event|Placebo (Discontinuation From Placebo)|AEs which occurred during the Discontinuation Period for participants who received placebo during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
95638|NCT01808612|E3|Reported Event|40 mg Fluoxetine (Treatment Period)|AEs which occurred during the Treatment Period for participants who received 40 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period
95639|NCT01808612|E2|Reported Event|20 mg Fluoxetine (Treatment Period)|AEs which occurred during the Treatment Period for participants who received 20 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period
95640|NCT01808612|E1|Reported Event|Placebo (Treatment Period)|Adverse events (AEs) which occurred during the Treatment Period for participants who received placebo administered orally, once daily, for 6 weeks during the Treatment Period
95641|NCT01808547|B3|Baseline|Total|Total of all reporting groups
95642|NCT01808547|B2|Baseline|Vehicle|DuraSite vehicle dosed BID
95643|NCT01808547|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite dosed BID
95644|NCT01808547|P2|Participant Flow|Vehicle|DuraSite vehicle dosed BID
95645|NCT01808547|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite dosed BID
95646|NCT01808547|O2|Outcome|Vehicle|DuraSite vehicle dosed BID
95647|NCT01808547|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite dosed BID
95648|NCT01808547|E2|Reported Event|Vehicle|DuraSite vehicle dosed BID
95649|NCT01808547|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite dosed BID
95650|NCT01808534|B1|Baseline|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
95651|NCT01808534|P1|Participant Flow|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
95652|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
95653|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
95654|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
95655|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
95656|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
95657|NCT01808534|E1|Reported Event|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
95658|NCT01808508|B4|Baseline|Total|Total of all reporting groups
95659|NCT01808508|B3|Baseline|Group 3 - No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group
95660|NCT01808508|B2|Baseline|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.
Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.
This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
95661|NCT01808508|B1|Baseline|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.
Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
95782|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
95662|NCT01808508|P3|Participant Flow|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
95663|NCT01808508|P2|Participant Flow|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.
Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.
This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
95664|NCT01808508|P1|Participant Flow|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.
Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
95665|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
95666|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.
Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.
This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
95667|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.
Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
95668|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
95669|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.
Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.
This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
95670|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.
Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
95671|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
95672|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.
Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.
This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
95673|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.
Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
95674|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
95675|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.
Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.
This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
95676|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.
Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
95677|NCT01808508|E3|Reported Event|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
95678|NCT01808508|E2|Reported Event|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.
Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.
This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
95679|NCT01808508|E1|Reported Event|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.
Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
95680|NCT01808339|B1|Baseline|FF 100 µg AM/FF 100 µg PM/Placebo|Participants received 3 treatments (A, B, and C) in either of the six sequences: ABC , ACB, BAC, BCA, CAB, or CBA. During treatment A participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI), during treatment B: participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI during treatment C: participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95681|NCT01808339|P6|Participant Flow|Placebo/FF 100 µg PM /FF 100 µg AM|Participants received 3 treatments (A, B, and C) in sequence CBA. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95682|NCT01808339|P5|Participant Flow|Placebo/FF 100 µg AM/FF 100 µg PM|Participants received 3 treatments (A, B, and C) in sequence CAB. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95683|NCT01808339|P4|Participant Flow|FF 100 µg PM /Placebo/FF 100 µg AM|Participants received 3 treatments (A, B, and C) in sequence BCA. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95684|NCT01808339|P3|Participant Flow|FF 100 µg PM /FF 100 µg AM/Placebo|Participants received 3 treatments (A, B, and C) in sequence BAC. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95685|NCT01808339|P2|Participant Flow|FF 100 µg AM/Placebo/FF 100 µg PM|Participants received 3 treatments (A, B, and C) in sequence ACB. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95737|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95768|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
95686|NCT01808339|P1|Participant Flow|FF 100 µg AM /FF 100 µg PM/Placebo|Participants received 3 treatments (A, B, and C) in sequence ABC. During treatment A participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI). During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95687|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95688|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95689|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95690|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95691|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95692|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95693|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95694|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95695|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95696|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95857|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95858|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95697|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95698|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95699|NCT01808339|E3|Reported Event|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95700|NCT01808339|E2|Reported Event|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95701|NCT01808339|E1|Reported Event|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
95702|NCT01808326|B1|Baseline|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95738|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95769|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
95703|NCT01808326|P1|Participant Flow|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95704|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95705|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95706|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95707|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95708|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95709|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95739|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95824|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95710|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95711|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95712|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95713|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95714|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95715|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95716|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95740|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95825|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95717|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95718|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95719|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95720|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95721|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95722|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95723|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95741|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95826|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95724|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95725|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95726|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95727|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95728|NCT01808326|E1|Reported Event|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
95729|NCT01808313|B1|Baseline|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95730|NCT01808313|P1|Participant Flow|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95731|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95732|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95733|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95734|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95735|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95736|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95742|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95743|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95744|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95745|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95746|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95747|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95748|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95749|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95750|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95751|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95752|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95753|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95859|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
98368|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone
Paromomycin: Paromomycin alone"
95754|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95755|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95756|NCT01808313|E1|Reported Event|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
95757|NCT01808248|B3|Baseline|Total|Total of all reporting groups
95758|NCT01808248|B2|Baseline|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
95759|NCT01808248|B1|Baseline|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 hepatitis C virus (HCV) infection.
95760|NCT01808248|P1|Participant Flow|SOF+PEG+RBV|Sofosbuvir (SOF) 400 mg tablet once daily + peginterferon alfa 2a (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
95761|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
95762|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
95763|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
95764|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
95765|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
95766|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
95767|NCT01808248|O1|Outcome|SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
95770|NCT01808248|E1|Reported Event|SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
95771|NCT01808209|B3|Baseline|Total|Total of all reporting groups
95772|NCT01808209|B2|Baseline|Filcon II 3 Then Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95773|NCT01808209|B1|Baseline|Stenfilcon A Then Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95774|NCT01808209|P2|Participant Flow|Filcon II 3 Then Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
95775|NCT01808209|P1|Participant Flow|Stenfilcon A Then Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95776|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95777|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95778|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
95779|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95780|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
95781|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95783|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
95784|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95785|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
95786|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
95787|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95788|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95789|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95790|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95791|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95792|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses..
95793|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95827|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95828|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95794|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95795|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses..
95796|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95797|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95798|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
95799|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95800|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95801|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
95802|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95803|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95804|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
95805|NCT01808209|O1|Outcome|Habitual Lens|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair was worn one week.
95806|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95807|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95808|NCT01808209|O1|Outcome|Habitual Lens|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair was worn one week.
95809|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95810|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95811|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95812|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
95813|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
95814|NCT01808209|E2|Reported Event|Filcon II 3|All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
95815|NCT01808209|E1|Reported Event|Stenfilcon A|All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
95816|NCT01808092|B3|Baseline|Total|Total of all reporting groups
95817|NCT01808092|B2|Baseline|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95818|NCT01808092|B1|Baseline|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95819|NCT01808092|P2|Participant Flow|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95820|NCT01808092|P1|Participant Flow|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95821|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95822|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95823|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95829|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95830|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95831|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95832|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95833|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95834|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95835|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95836|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95837|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95838|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95839|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95840|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95841|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95842|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95843|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95844|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95845|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95846|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95847|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95848|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95849|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95850|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95851|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95852|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95853|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95854|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95855|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95856|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95860|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95861|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95862|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95863|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95864|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95865|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95866|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95867|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95868|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95869|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95870|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95871|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95872|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95873|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95874|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95875|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95876|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95877|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95878|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95879|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95880|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95881|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95882|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95883|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95884|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95885|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95886|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95887|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95888|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95889|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95890|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95891|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95892|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95893|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95894|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95895|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95896|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95897|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95898|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95899|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95900|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95901|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95902|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95903|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95904|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95905|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95906|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95907|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95908|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95909|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95910|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95911|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95912|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95913|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95914|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95915|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95916|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95917|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95918|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95919|NCT01808092|E2|Reported Event|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
95920|NCT01808092|E1|Reported Event|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
95921|NCT01808066|B1|Baseline|Play Groundskeeper|"This study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab & Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time.
Groundskeeper: Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task."
95922|NCT01808066|P1|Participant Flow|Treatment Group|21 participants with ADHD who underwent the intervention for 3 weeks, played for 20 minutes at a time at school.
95923|NCT01808066|O1|Outcome|Play Groundskeeper|"This study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab & Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time.
Groundskeeper: Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task."
95924|NCT01808066|E1|Reported Event|Treatment Group|21 participants with ADHD who underwent the intervention for 3 weeks, played for 20 minutes at a time at school.
95925|NCT01807949|B4|Baseline|Total|Total of all reporting groups
95926|NCT01807949|B3|Baseline|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95927|NCT01807949|B2|Baseline|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95928|NCT01807949|B1|Baseline|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95929|NCT01807949|P3|Participant Flow|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95930|NCT01807949|P2|Participant Flow|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95931|NCT01807949|P1|Participant Flow|Placebo|Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
95932|NCT01807949|O2|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95933|NCT01807949|O1|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95934|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95935|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95936|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95937|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95938|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95939|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95940|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95941|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95942|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95943|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95944|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95945|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95946|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95947|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95948|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95949|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95950|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95951|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95999|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95952|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95953|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95954|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95955|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95956|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95957|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95958|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95959|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95960|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95961|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95962|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95963|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95964|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95965|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95966|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95967|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95968|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95969|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95970|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95971|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95972|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95973|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95974|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95975|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95976|NCT01807949|E3|Reported Event|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95977|NCT01807949|E2|Reported Event|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95978|NCT01807949|E1|Reported Event|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95979|NCT01807923|B4|Baseline|Total|Total of all reporting groups
95980|NCT01807923|B3|Baseline|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95981|NCT01807923|B2|Baseline|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95982|NCT01807923|B1|Baseline|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95983|NCT01807923|P3|Participant Flow|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95984|NCT01807923|P2|Participant Flow|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95985|NCT01807923|P1|Participant Flow|Placebo|Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
95986|NCT01807923|O2|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95987|NCT01807923|O1|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95988|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95989|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95990|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95991|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95992|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95993|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95994|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95995|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
95996|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
95997|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
95998|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96000|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
96001|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96002|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
96003|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
96004|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96005|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
96006|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
96007|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96008|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
96009|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
96010|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96011|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
96012|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
96013|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96014|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
96015|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
96016|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96017|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
96018|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
96019|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96021|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
96022|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96023|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
96024|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
96025|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96026|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
96027|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
96028|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96029|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
96030|NCT01807923|E3|Reported Event|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
96031|NCT01807923|E2|Reported Event|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
96032|NCT01807923|E1|Reported Event|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
96033|NCT01807871|B3|Baseline|Total|Total of all reporting groups
96034|NCT01807871|B2|Baseline|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
96035|NCT01807871|B1|Baseline|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
96036|NCT01807871|P2|Participant Flow|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
96037|NCT01807871|P1|Participant Flow|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
96038|NCT01807871|O2|Outcome|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
98612|NCT01788163|B6|Baseline|Singapore|Subjects in Singapore that meet I/E and population criteria
96039|NCT01807871|O1|Outcome|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
96040|NCT01807871|O2|Outcome|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
96041|NCT01807871|O1|Outcome|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
96042|NCT01807871|O2|Outcome|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
96043|NCT01807871|O1|Outcome|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
96044|NCT01807871|E2|Reported Event|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
96045|NCT01807871|E1|Reported Event|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
96943|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96046|NCT01807624|B1|Baseline|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96047|NCT01807624|P1|Participant Flow|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96048|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96049|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96050|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96051|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96052|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96053|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96054|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96055|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96056|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96057|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96058|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96089|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96059|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96060|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96061|NCT01807624|E1|Reported Event|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
96062|NCT01807455|B1|Baseline|Restylane Vital Lidocaine|Restylane Vital Lidocaine
96063|NCT01807455|P1|Participant Flow|Restylane Vital Lidocaine|Restylane Vital Lidocaine
96064|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
96065|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
96066|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
96067|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
96068|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
96069|NCT01807455|E1|Reported Event|Restylane Vital Lidocaine|Restylane Vital Lidocaine
96070|NCT01807234|B7|Baseline|Total|Total of all reporting groups
96071|NCT01807234|B6|Baseline|Placebo Then Sumatriptan Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
96072|NCT01807234|B5|Baseline|Placebo Then Ketorolac Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
96073|NCT01807234|B4|Baseline|Sumatriptan Then Placebo Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
96074|NCT01807234|B3|Baseline|Sumatriptan Then Ketorolac Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
96075|NCT01807234|B2|Baseline|Ketorolac Then Placebo Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
96076|NCT01807234|B1|Baseline|Ketorolac Then Sumatriptan Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
96090|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96091|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96077|NCT01807234|P6|Participant Flow|Placebo Then Sumatriptan Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
96078|NCT01807234|P5|Participant Flow|Placebo Then Ketorolac Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
96079|NCT01807234|P4|Participant Flow|Sumatriptan Then Placebo Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
96080|NCT01807234|P3|Participant Flow|Sumatriptan Then Ketorolac Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
96103|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96104|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96129|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96081|NCT01807234|P2|Participant Flow|Kerorolac Then Placebo Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
96082|NCT01807234|P1|Participant Flow|Ketorolac Then Sumatriptan Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
96083|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96084|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96085|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96086|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96087|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96088|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96092|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96093|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96094|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96095|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96096|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96097|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96098|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96099|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96100|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96101|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96102|NCT01807234|O2|Outcome|Sumatriptan/Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96944|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96105|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96106|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96107|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96108|NCT01807234|O2|Outcome|Sumatriptan/Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96109|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96110|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96111|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96112|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
96113|NCT01807234|E3|Reported Event|SRIX Placebo/Sumatriptan Placebo|"single dose SPRIX placebo, single dose Sumatriptan placebo
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
The most common adverse event for placebo were unusual taste (mild in 4%, moderate in 2%), nausea (4%), rash (4%), fatigue (4%), burning of the nose (2%), dizziness (2%)."
96114|NCT01807234|E2|Reported Event|Sumatriptan/Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
For those treated with sumatriptan NS the most common adverse events were unusual taste (mild in 24.5%, moderate in 12.2%, severe 4.1%), burning of the nose (mild in 6.1%, moderate in 2%), nausea (8%), burning of the throat (6%), nasal discomfort (6%), dizziness (4%), fatigue (4%) and rash (2%)."
96115|NCT01807234|E1|Reported Event|Sprix/Placebo|"Sprix 31.5 mg single dose nasal spray and Placebo
SPRIX: Single dose of Sprix nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
The most common adverse events reported by participants treated with ketorolac NS were burning of nose, (mild in 25.5%, moderate in 19.6% and severe in 3.9%), unusual taste (mild in 2%, moderate in 5.9%, severe 2%), nasal discomfort (8%), burning of throat (6%), fatigue (4%), dizziness (4%), nausea (2%), rash (2%)."
96161|NCT01806857|O2|Outcome|Matching Placebo|
96162|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
96163|NCT01806857|O2|Outcome|Matching Placebo|
96164|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
96165|NCT01806857|O2|Outcome|Matching Placebo|
96116|NCT01807156|B1|Baseline|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.
Tivozanib: Oral medication given daily. No placebo."
96117|NCT01807156|P1|Participant Flow|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.
Tivozanib: Oral medication given daily. No placebo."
96118|NCT01807156|O1|Outcome|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.
Tivozanib: Oral medication given daily. No placebo."
96119|NCT01807156|O1|Outcome|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.
Tivozanib: Oral medication given daily. No placebo."
96120|NCT01807156|E1|Reported Event|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.
Tivozanib: Oral medication given daily. No placebo."
96121|NCT01807000|B1|Baseline|[14C] PRUCALOPRIDE SUCCINATE|
96122|NCT01807000|P1|Participant Flow|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96123|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96124|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96125|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96126|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96127|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96128|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96998|NCT01800916|E3|Reported Event|Test C|
96130|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96131|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96132|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96133|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96134|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96135|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96136|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96137|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96138|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96139|NCT01807000|E1|Reported Event|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
96140|NCT01806961|B1|Baseline|Clearance at End of Trial SP848-AK-1101|no trial medication during this follow-up trial
96141|NCT01806961|P1|Participant Flow|SP848-AK-1101|Patients from SP848-AK-1101 trial
96142|NCT01806961|O1|Outcome|Group 1|Patients from SP848-AK-1101 trial
96143|NCT01806961|E1|Reported Event|Group 1|Patients from SP848-AK-1101 trial
96144|NCT01806857|B1|Baseline|All Study Participants|
96145|NCT01806857|P2|Participant Flow|Matching Placebo Then Nuedexta|"Subjects in this arm will receive treatment with matching placebo first for 28 days (±3 days) and then crossed over to receive treatment with Nuedexta for 28 days (±3 days).
Nuedexta: Nuedexta PO (by mouth) for 28 ± 3 days
Matching Placebo: matching placebo PO (by mouth) for 28 ± 3 days"
96146|NCT01806857|P1|Participant Flow|Nuedexta Then Matching Placebo|"Subjects in this arm will receive treatment with Nuedexta first for 28 days (±3 days) and then crossed over to receive treatment with matching placebo for 28 days (±3 days).
Nuedexta: Nuedexta PO (by mouth) for 28 ± 3 days
Matching Placebo: matching placebo PO (by mouth) for 28 ± 3 days"
96147|NCT01806857|O2|Outcome|Matching Placebo|
96148|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
96149|NCT01806857|O2|Outcome|Matching Placebo|
96150|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
96151|NCT01806857|O2|Outcome|Matching Placebo|
96152|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
96153|NCT01806857|O2|Outcome|Matching Placebo|
96154|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
96155|NCT01806857|O2|Outcome|Matching Placebo|
96156|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
96157|NCT01806857|O2|Outcome|Matching Placebo|
96158|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
96159|NCT01806857|O2|Outcome|Matching Placebo|
96160|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
96180|NCT01806857|E1|Reported Event|Active Drug (Neudexta)|Includes all subjects that took the active drug (Neudexta)
96181|NCT01806779|B3|Baseline|Total|Total of all reporting groups
96182|NCT01806779|B2|Baseline|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96183|NCT01806779|B1|Baseline|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96184|NCT01806779|P3|Participant Flow|Nicotine Patches Only|These subjects received nicotine patches at the first study visit but dropped out before randomization. 176 subjects attended the second study visit and provided side effects (SE) data. Two of these subjects dropped out during that visit (after providing SE data but prior to randomization). So, out of the initial 197 subjects receiving nicotine patches, 174 went on to receive Chantix or Chantix+Zyban; 23 subjects only received nicotine patches before dropping out.
96424|NCT01804842|B2|Baseline|Sequence 2: BCA|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
96185|NCT01806779|P2|Participant Flow|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96186|NCT01806779|P1|Participant Flow|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96187|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96188|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96189|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96190|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96191|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96192|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96215|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
98613|NCT01788163|B5|Baseline|Thailand|Subjects in Thailand that meet I/E and population criteria
96193|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96194|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96195|NCT01806779|E3|Reported Event|Nicotine Patch|All participants will receive Nicotine Replacement Therapy (NRT) in the form of 21 mg/24 h dose nicotine patches for 1 week prior to randomization to treatment with Chantix alone or Chantix + Zyban.
96196|NCT01806779|E2|Reported Event|Chantix + Zyban|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96425|NCT01804842|B1|Baseline|Sequence 1: ABC|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
96197|NCT01806779|E1|Reported Event|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
96198|NCT01806714|B3|Baseline|Total|Total of all reporting groups
96199|NCT01806714|B2|Baseline|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
96200|NCT01806714|B1|Baseline|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit
Text-based reminder for recommended HPV vaccine or well care visit"
96201|NCT01806714|P2|Participant Flow|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
96202|NCT01806714|P1|Participant Flow|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit
Text-based reminder for recommended HPV vaccine or well care visit"
96203|NCT01806714|O2|Outcome|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
96204|NCT01806714|O1|Outcome|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit
Text-based reminder for recommended HPV vaccine or well care visit"
96205|NCT01806714|O2|Outcome|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
96206|NCT01806714|O1|Outcome|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit
Text-based reminder for recommended HPV vaccine or well care visit"
96207|NCT01806714|O2|Outcome|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
96208|NCT01806714|O1|Outcome|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit
Text-based reminder for recommended HPV vaccine or well care visit"
96209|NCT01806714|E2|Reported Event|Control Arm|"Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)"
96210|NCT01806714|E1|Reported Event|Text-based Reminder for HPV Vaccine/WCC|"Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit
Text-based reminder for recommended HPV vaccine or well care visit"
96211|NCT01806623|B1|Baseline|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96212|NCT01806623|P1|Participant Flow|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96213|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96214|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96216|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96217|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96218|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96219|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96220|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96221|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96222|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96223|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96224|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96225|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96226|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96227|NCT01806623|E1|Reported Event|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
96228|NCT01806584|B3|Baseline|Total|Total of all reporting groups
96247|NCT01806545|P1|Participant Flow|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96229|NCT01806584|B2|Baseline|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.
After surgery, subjects were to undergo assessments during the 78-week follow-up period."
96230|NCT01806584|B1|Baseline|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
96231|NCT01806584|P2|Participant Flow|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.
After surgery, subjects were to undergo assessments during the 78-week follow-up period."
96232|NCT01806584|P1|Participant Flow|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
96233|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.
After surgery, subjects were to undergo assessments during the 78-week follow-up period."
96234|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
96235|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.
After surgery, subjects were to undergo assessments during the 78-week follow-up period."
96236|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
96237|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.
After surgery, subjects were to undergo assessments during the 78-week follow-up period."
96238|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
96239|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.
After surgery, subjects were to undergo assessments during the 78-week follow-up period."
96240|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
96284|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
98614|NCT01788163|B4|Baseline|Australia|Subjects in Australia that meet I/E and population criteria
96241|NCT01806584|E2|Reported Event|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.
After surgery, subjects were to undergo assessments during the 78-week follow-up period."
96242|NCT01806584|E1|Reported Event|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
96243|NCT01806545|B3|Baseline|Total|Total of all reporting groups
96244|NCT01806545|B2|Baseline|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96245|NCT01806545|B1|Baseline|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96246|NCT01806545|P2|Participant Flow|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96420|NCT01804881|E2|Reported Event|Wait List Control|wait list, offered craving change program at end of study
96999|NCT01800916|E2|Reported Event|Test B|
96248|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96249|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96250|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96251|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96252|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96253|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96254|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96255|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96256|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96257|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96258|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96259|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96260|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96261|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96262|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96263|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96264|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96265|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
97000|NCT01800916|E1|Reported Event|Test A|
96266|NCT01806545|E2|Reported Event|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96267|NCT01806545|E1|Reported Event|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
96268|NCT01806389|B1|Baseline|Buprenorphine Maintained Lactating Women|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria
96269|NCT01806389|P1|Participant Flow|Buprenorphine Maintained Lactating Women|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria
96270|NCT01806389|O1|Outcome|INFANT PLASMA Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing INFANT PLASMA for analysis on day 14
96271|NCT01806389|O5|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 30|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 30
96272|NCT01806389|O4|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 14
96273|NCT01806389|O3|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 4|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 4
96274|NCT01806389|O2|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 3|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 3
96275|NCT01806389|O1|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 2|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing breast milk for analysis on day 2
96276|NCT01806389|O5|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 30|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 30
96277|NCT01806389|O4|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 14
96278|NCT01806389|O3|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 4|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 4
96279|NCT01806389|O2|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 3|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 3
96280|NCT01806389|O1|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 2|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 2
96281|NCT01806389|E1|Reported Event|Buprenorphine|Buprenorphine maintained women at delivery of their infant
96282|NCT01806298|B1|Baseline|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
96283|NCT01806298|P1|Participant Flow|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
96338|NCT01805687|E1|Reported Event|Zileuton Extended Release|Zileuton extended release
96285|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
96286|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
96287|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
96288|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
96289|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
96290|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
96291|NCT01806298|E1|Reported Event|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
96292|NCT01806051|B1|Baseline|All Participants|
96293|NCT01806051|P1|Participant Flow|All Participants|Participants signed the consent forms and withdrew because they found the study procedures to be too cumbersome.
96294|NCT01806051|O2|Outcome|Control Group (Arm 2)|"Subjects allocated into this group will be healthy, non-PKU individuals that may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.
These subjects will undergo a 24-Hour Blood Assessment (at Study Visit #2)."
96421|NCT01804881|E1|Reported Event|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions
Lifestyle counseling: Six week program to address problematic eating"
96295|NCT01806051|O1|Outcome|PKU Participants (Arm 1)|"Subjects will be administered Kuvan once daily.
They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6).
Kuvan: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks."
96296|NCT01806051|E2|Reported Event|Control Group (Arm 2)|"Subjects allocated into this group will be healthy, non-PKU individuals that may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.
These subjects will undergo a 24-Hour Blood Assessment (at Study Visit #2)."
96297|NCT01806051|E1|Reported Event|PKU Participants (Arm 1)|"Subjects will be administered Kuvan once daily.
They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6).
Kuvan: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks."
96298|NCT01805882|B10|Baseline|Total|Total of all reporting groups
96299|NCT01805882|B9|Baseline|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
96300|NCT01805882|B8|Baseline|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
96301|NCT01805882|B7|Baseline|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
96302|NCT01805882|B6|Baseline|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
96303|NCT01805882|B5|Baseline|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
96304|NCT01805882|B4|Baseline|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
96305|NCT01805882|B3|Baseline|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
96306|NCT01805882|B2|Baseline|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
96307|NCT01805882|B1|Baseline|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
96308|NCT01805882|P9|Participant Flow|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
96309|NCT01805882|P8|Participant Flow|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
96339|NCT01805323|B1|Baseline|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
96310|NCT01805882|P7|Participant Flow|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
96311|NCT01805882|P6|Participant Flow|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
96312|NCT01805882|P5|Participant Flow|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
96313|NCT01805882|P4|Participant Flow|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
96314|NCT01805882|P3|Participant Flow|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
96315|NCT01805882|P2|Participant Flow|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
96316|NCT01805882|P1|Participant Flow|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
96317|NCT01805882|O9|Outcome|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
96318|NCT01805882|O8|Outcome|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
96422|NCT01804842|B4|Baseline|Total|Total of all reporting groups
96319|NCT01805882|O7|Outcome|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
96320|NCT01805882|O6|Outcome|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
96321|NCT01805882|O5|Outcome|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
96322|NCT01805882|O4|Outcome|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
96323|NCT01805882|O3|Outcome|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
96324|NCT01805882|O2|Outcome|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
96325|NCT01805882|O1|Outcome|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
96326|NCT01805882|E9|Reported Event|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
96327|NCT01805882|E8|Reported Event|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
96328|NCT01805882|E7|Reported Event|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
96329|NCT01805882|E6|Reported Event|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
96330|NCT01805882|E5|Reported Event|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
96331|NCT01805882|E4|Reported Event|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
96332|NCT01805882|E3|Reported Event|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
96333|NCT01805882|E2|Reported Event|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
96334|NCT01805882|E1|Reported Event|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
96335|NCT01805687|B1|Baseline|Zileuton Extended Release|Zileuton extended release
96336|NCT01805687|P1|Participant Flow|Zileuton Extended Release|Zileuton extended release 1200 mg (2 x 600 mg tablets)
96337|NCT01805687|O1|Outcome|Zileuton Extended Release|Zileuton extended release
96340|NCT01805323|P1|Participant Flow|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
96341|NCT01805323|O1|Outcome|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
96342|NCT01805323|O1|Outcome|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
96343|NCT01805323|E1|Reported Event|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
96344|NCT01805180|B3|Baseline|Total|Total of all reporting groups
96345|NCT01805180|B2|Baseline|Arm 2|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
96346|NCT01805180|B1|Baseline|Arm 1|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
96347|NCT01805180|P3|Participant Flow|Arm 2 - COBE Spectra Followed by Spectra Optia PMN|Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the COBE Spectra first, followed by the Spectra Optia.
96348|NCT01805180|P2|Participant Flow|Arm 1 - Spectra Optia Followed by COBE Spectra PMN|Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the Spectra Optia first, followed by the COBE Spectra.
96349|NCT01805180|P1|Participant Flow|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
96423|NCT01804842|B3|Baseline|Sequence 3: CAB|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
96350|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. RBC contamination results via hematocrit in collected product not reported by randomization treatment arms.
96351|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. Device deficiency was not reported by randomization treatment arms.
96352|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
96353|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
96354|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
96355|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
96356|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
96357|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
96358|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. RBC contamination results via hematocrit in collected product not reported by randomization treatment arms.
96359|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
96360|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
96361|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
96362|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
96363|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
96364|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
96365|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
96366|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
96367|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
96368|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
96369|NCT01805180|E2|Reported Event|COBE Spectra|A total of n=42 subjects were randomized to receive a procedure. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Lead-in subjects are never exposed to COBE Spectra per protocol and not included. COBE Spectra events are AEs during the study period when the subject received the COBE Spectra.
96370|NCT01805180|E1|Reported Event|Spectra Optia|A total of n=48 subjects were either randomized to receive a procedure (n=42) or were assigned the Spectra Optia as a lead-in subject (lead-in n=6). Lead-in donors were not randomized and received the Spectra Optia only for training purposes and are included for Spectra Optia safety only. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Spectra Optia events are AEs during the study period when the subject received the Spectra Optia.
96371|NCT01805089|B3|Baseline|Total|Total of all reporting groups
96372|NCT01805089|B2|Baseline|Placebo|"Taken orally, once per day, at/around 9:00pm
Placebo"
96373|NCT01805089|B1|Baseline|Melatonin|"Taken orally, once per day, at/around 9:00pm
Melatonin"
96374|NCT01805089|P2|Participant Flow|Placebo|"Taken orally, once per day, at/around 9:00pm
Placebo"
96375|NCT01805089|P1|Participant Flow|Melatonin 3mg|"Taken orally, once per day, at/around 9:00pm
Melatonin"
96376|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm
Placebo"
96377|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm
Melatonin"
96378|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm
Placebo"
96379|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm
Melatonin"
96380|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm
Placebo"
96381|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm
Melatonin"
96382|NCT01805089|E2|Reported Event|Placebo|"Taken orally, once per day, at/around 9:00pm
Placebo"
96383|NCT01805089|E1|Reported Event|Melatonin|"Taken orally, once per day, at/around 9:00pm
Melatonin"
96384|NCT01804946|B3|Baseline|Total|Total of all reporting groups
96385|NCT01804946|B2|Baseline|Oseltamivir Group (OG)|Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
96386|NCT01804946|B1|Baseline|Ergoferon Group (EG)|"1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza"
96387|NCT01804946|P2|Participant Flow|Oseltamivir Group (OG)|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
96388|NCT01804946|P1|Participant Flow|Ergoferon Group (EG)|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
96389|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
96390|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
96391|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
96392|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
96393|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
96394|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
96395|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
96396|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
96397|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
96398|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
96399|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
96400|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
96401|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
96402|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
96403|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
96404|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
96405|NCT01804946|O2|Outcome|Oseltamivir Goup (OG)|Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
96406|NCT01804946|O1|Outcome|Ergoferon Group (EG)|"1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza"
96407|NCT01804946|E2|Reported Event|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
96408|NCT01804946|E1|Reported Event|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
96409|NCT01804881|B3|Baseline|Total|Total of all reporting groups
96410|NCT01804881|B2|Baseline|Wait List Control|wait list, offered program based on craving change(tm) material at end of study
96411|NCT01804881|B1|Baseline|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions
Lifestyle counseling: Six week program to address problematic eating"
96412|NCT01804881|P2|Participant Flow|Wait List Control|wait list, offered program based on craving change(tm) material at end of study
96413|NCT01804881|P1|Participant Flow|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions
Lifestyle counseling: Six week program to address problematic eating"
96414|NCT01804881|O2|Outcome|Wait List Control|wait list, offered group program at end of study
96415|NCT01804881|O1|Outcome|Lifestyle Counseling|"Group intervention for dietary counseling, 6 group sessions
Lifestyle counseling: Six week program to address problematic eating"
96416|NCT01804881|O2|Outcome|Wait List Control|wait list, offered group program at end of study
96417|NCT01804881|O1|Outcome|Lifestyle Counseling|"Group intervention for dietary counseling, 6 group sessions
Lifestyle counseling: Six week program to address problematic eating"
96418|NCT01804881|O2|Outcome|Wait List Control|wait list, offered craving change program at end of study
96419|NCT01804881|O1|Outcome|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions
Lifestyle counseling: Six week program to address problematic eating"
96426|NCT01804842|P3|Participant Flow|Sequence 3: CAB|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
96427|NCT01804842|P2|Participant Flow|Sequence 2: BCA|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
96428|NCT01804842|P1|Participant Flow|Sequence 1: ABC|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
96429|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening
Met DR: metformin delayed-release tablets"
96430|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning
Met DR: metformin delayed-release tablets"
96431|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release
Met DR: metformin delayed-release tablets"
96432|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening
Met DR: metformin delayed-release tablets"
96433|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning
Met DR: metformin delayed-release tablets"
96434|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release
Met DR: metformin delayed-release tablets"
96435|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening
Met DR: metformin delayed-release tablets"
96436|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning
Met DR: metformin delayed-release tablets"
96437|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release
Met DR: metformin delayed-release tablets"
96438|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening
Met DR: metformin delayed-release tablets"
96439|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning
Met DR: metformin delayed-release tablets"
96440|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release
Met DR: metformin delayed-release tablets"
96441|NCT01804842|E3|Reported Event|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release
Met DR: metformin delayed-release tablets"
96442|NCT01804842|E2|Reported Event|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening
Met DR: metformin delayed-release tablets"
96443|NCT01804842|E1|Reported Event|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning
Met DR: metformin delayed-release tablets"
96444|NCT01804673|B1|Baseline|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96445|NCT01804673|P1|Participant Flow|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96446|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96447|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96448|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96449|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96450|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96451|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96452|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96453|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96454|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96455|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96456|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96532|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96457|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96458|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96459|NCT01804673|E1|Reported Event|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
96460|NCT01804257|B1|Baseline|Digital Health Feedback System (DHFS)|"Ingestion Sensor, Wearable Sensor
Digital Health Feedback System: The digital health offering passively collects and records medication-taking behavior and other habits of daily living"
96461|NCT01804257|P1|Participant Flow|Digital Health Feedback System (DHFS)|"Ingestion Sensor, Wearable Sensor
Digital Health Feedback System: The digital health offering passively collects and records medication-taking behavior and other habits of daily living"
96462|NCT01804257|O1|Outcome|Digital Health Feedback System (DHFS)|Ingestion Sensor,...
96463|NCT01804257|E1|Reported Event|Digital Health Feedback System (DHFS)|DHFS
96464|NCT01804140|B1|Baseline|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
96465|NCT01804140|P1|Participant Flow|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
96466|NCT01804140|O1|Outcome|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
96467|NCT01804140|O1|Outcome|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
96468|NCT01804140|E1|Reported Event|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
96469|NCT01804075|B3|Baseline|Total|Total of all reporting groups
96470|NCT01804075|B2|Baseline|Methadone Treated|infants randomized to receive methadone as their primary treatment for withdrawal
96471|NCT01804075|B1|Baseline|Morphine Treated|infants randomized to receive morphine as their primary treatment for withdrawal
96472|NCT01804075|P2|Participant Flow|Morphine|"Morphine (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:
NAS Score Morphine 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose
Maximum dose of morphine will be 0.2 mg/kg/dose. (NeoFax)
Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 6 hours, until NAS scores are consistently <8 for 48 hours.
If the maximum dose of morphine is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.
Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
96625|NCT01802515|E1|Reported Event|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.
Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
96473|NCT01804075|P1|Participant Flow|Methadone|"Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:
NAS Score Methadone 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose
Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax)
Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently <8 for 48 hours.
If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.
Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
96474|NCT01804075|O2|Outcome|Morphine Treated|infants randomized to receive morphine as their primary treatment for withdrawal
96475|NCT01804075|O1|Outcome|Methadone Treated|infants randomized to receive methadone as their primary treatment for withdrawal
96476|NCT01804075|O2|Outcome|Morphine-treated|Group randomized to receive morphine treatment for their withdrawal
96477|NCT01804075|O1|Outcome|Methadone-treated|group of infants randomized to receive methadone treatment for their withdrawal
96478|NCT01804075|E2|Reported Event|Morphine|"Morphine (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:
NAS Score Morphine 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose
Maximum dose of morphine will be 0.2 mg/kg/dose. (NeoFax)
Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 6 hours, until NAS scores are consistently <8 for 48 hours.
If the maximum dose of morphine is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.
Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
96507|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem:
Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
96576|NCT01802632|P5|Participant Flow|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
96479|NCT01804075|E1|Reported Event|Methadone|"Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:
NAS Score Methadone 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose
Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax)
Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently <8 for 48 hours.
If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.
Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine."
96480|NCT01804062|B1|Baseline|no Treatment|no treatment, prospective observational
96481|NCT01804062|P1|Participant Flow|no Treatment|no treatment, prospective observational
96482|NCT01804062|O1|Outcome|no Treatment|no treatment, prospective observational
96483|NCT01804062|O1|Outcome|no Treatment|no treatment, prospective observational
96484|NCT01804062|E1|Reported Event|no Treatment|no treatment, prospective observational
96485|NCT01804036|B3|Baseline|Total|Total of all reporting groups
96486|NCT01804036|B2|Baseline|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96487|NCT01804036|B1|Baseline|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
96488|NCT01804036|P2|Participant Flow|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96489|NCT01804036|P1|Participant Flow|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem:
Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
96490|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96491|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
96492|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96493|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
96494|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96495|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
96496|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96497|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem:
Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
96498|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96767|NCT01801358|B4|Baseline|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96499|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem:
Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
96500|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96501|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem:
Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
96502|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96503|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem:
Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
96504|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96505|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem:
Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
96506|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96508|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96509|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem:
Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
96510|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96511|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
96512|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96513|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
96514|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96515|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem:
Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
96516|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96517|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem:
Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
96518|NCT01804036|E2|Reported Event|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
96519|NCT01804036|E1|Reported Event|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem
Zolpidem:
Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
96520|NCT01803737|B3|Baseline|Total|Total of all reporting groups
96521|NCT01803737|B2|Baseline|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96522|NCT01803737|B1|Baseline|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96523|NCT01803737|P2|Participant Flow|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96524|NCT01803737|P1|Participant Flow|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96525|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96526|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96527|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96528|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96529|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96530|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96531|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96533|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96534|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96535|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96536|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96537|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96538|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96539|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96540|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96541|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96542|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96543|NCT01803737|E2|Reported Event|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
96544|NCT01803737|E1|Reported Event|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
96545|NCT01803607|B3|Baseline|Total|Total of all reporting groups
96626|NCT01802320|B1|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
96546|NCT01803607|B2|Baseline|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96547|NCT01803607|B1|Baseline|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96548|NCT01803607|P2|Participant Flow|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96549|NCT01803607|P1|Participant Flow|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96550|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96551|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96552|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96577|NCT01802632|P4|Participant Flow|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
96553|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96554|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96555|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96556|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96557|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96558|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96559|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96560|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96561|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96562|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96563|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96976|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96564|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96565|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96566|NCT01803607|E2|Reported Event|Placebo OW|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. One participant who was randomized to odanacatib 50 mg OW received placebo during the entire treatment period and was therefore included in the Placebo OW group for safety analyses.
96567|NCT01803607|E1|Reported Event|ODN 50 mg OW|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
96568|NCT01802632|B7|Baseline|Total|Total of all reporting groups
96569|NCT01802632|B6|Baseline|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
96570|NCT01802632|B5|Baseline|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
96571|NCT01802632|B4|Baseline|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
96572|NCT01802632|B3|Baseline|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
96573|NCT01802632|B2|Baseline|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
96574|NCT01802632|B1|Baseline|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
96575|NCT01802632|P6|Participant Flow|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
96578|NCT01802632|P3|Participant Flow|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
96579|NCT01802632|P2|Participant Flow|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
96580|NCT01802632|P1|Participant Flow|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
96581|NCT01802632|O1|Outcome|80mg AZD9291 Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
96582|NCT01802632|O1|Outcome|80mg AZD9291 Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
96583|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
96584|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
96585|NCT01802632|O1|Outcome|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
96586|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
96587|NCT01802632|E6|Reported Event|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
96588|NCT01802632|E5|Reported Event|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
96589|NCT01802632|E4|Reported Event|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
96590|NCT01802632|E3|Reported Event|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
96591|NCT01802632|E2|Reported Event|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
96592|NCT01802632|E1|Reported Event|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
96593|NCT01802554|B3|Baseline|Total|Total of all reporting groups
96594|NCT01802554|B2|Baseline|Information Support (IS)|Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.
96595|NCT01802554|B1|Baseline|Pleasant Events Program (PEP)|The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
96627|NCT01802320|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
96768|NCT01801358|B3|Baseline|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96596|NCT01802554|P2|Participant Flow|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
Pleasant Events Program (PEP) : Behavioral Activation Therapy"
96597|NCT01802554|P1|Participant Flow|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.
Information Support (IS) : Supportive Psychotherapy and informational brochures"
96598|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.
Information Support (IS): Supportive Psychotherapy and informational brochures"
96599|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
Pleasant Events Program (PEP): Behavioral Activation Therapy"
96612|NCT01802515|B2|Baseline|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules
Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
96613|NCT01802515|B1|Baseline|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.
Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
97283|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
96600|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.
Information Support (IS): Supportive Psychotherapy and informational brochures"
96601|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
Pleasant Events Program (PEP): Behavioral Activation Therapy"
96602|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.
Information Support (IS): Supportive Psychotherapy and informational brochures"
96603|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
Pleasant Events Program (PEP): Behavioral Activation Therapy"
96604|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.
Information Support (IS): Supportive Psychotherapy and informational brochures"
96628|NCT01802320|O1|Outcome|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
96605|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
Pleasant Events Program (PEP): Behavioral Activation Therapy"
96606|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.
Information Support (IS): Supportive Psychotherapy and informational brochures"
96607|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
Pleasant Events Program (PEP): Behavioral Activation Therapy"
96608|NCT01802554|E2|Reported Event|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.
Information Support (IS): Supportive Psychotherapy and informational brochures"
96609|NCT01802554|E1|Reported Event|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
Pleasant Events Program (PEP): Behavioral Activation Therapy"
96610|NCT01802515|B4|Baseline|Total|Total of all reporting groups
96611|NCT01802515|B3|Baseline|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.
Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
96940|NCT01800968|B1|Baseline|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96614|NCT01802515|P3|Participant Flow|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.
Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
96615|NCT01802515|P2|Participant Flow|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules
Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
96616|NCT01802515|P1|Participant Flow|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.
Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
96617|NCT01802515|O3|Outcome|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.
Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
96618|NCT01802515|O2|Outcome|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules
Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
96619|NCT01802515|O1|Outcome|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.
Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
96620|NCT01802515|O3|Outcome|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.
Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
96621|NCT01802515|O2|Outcome|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules
Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
96622|NCT01802515|O1|Outcome|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.
Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
96623|NCT01802515|E3|Reported Event|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.
Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
96624|NCT01802515|E2|Reported Event|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules
Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
96629|NCT01802320|O1|Outcome|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
96630|NCT01802320|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
96631|NCT01802151|B5|Baseline|Total|Total of all reporting groups
96632|NCT01802151|B4|Baseline|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96633|NCT01802151|B3|Baseline|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96634|NCT01802151|B2|Baseline|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96635|NCT01802151|B1|Baseline|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96636|NCT01802151|P4|Participant Flow|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96637|NCT01802151|P3|Participant Flow|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96638|NCT01802151|P2|Participant Flow|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96639|NCT01802151|P1|Participant Flow|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96640|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96641|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96642|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96643|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96644|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96645|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96646|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96647|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96648|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96649|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96650|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96651|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96652|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96653|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96654|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96655|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96656|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96657|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96658|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96659|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96977|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96660|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96661|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96662|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96663|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96664|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96665|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96666|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96667|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96668|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96669|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96670|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96671|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96672|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96673|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96674|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96675|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96676|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96677|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96678|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96679|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96680|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96681|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96682|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96683|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96684|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96685|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96686|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96687|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96688|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96689|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96690|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96691|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96692|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96693|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96694|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96695|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96696|NCT01802151|E4|Reported Event|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96697|NCT01802151|E3|Reported Event|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96698|NCT01802151|E2|Reported Event|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
96699|NCT01802151|E1|Reported Event|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
96700|NCT01801982|B1|Baseline|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
96701|NCT01801982|P1|Participant Flow|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
96702|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
97384|NCT01798264|P1|Participant Flow|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
96703|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
96704|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
96705|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
96706|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
96707|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
96708|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
96709|NCT01801982|E1|Reported Event|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
96710|NCT01801735|B1|Baseline|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
96711|NCT01801735|P1|Participant Flow|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
96712|NCT01801735|O1|Outcome|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
96713|NCT01801735|E1|Reported Event|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
96714|NCT01801475|B4|Baseline|Total|Total of all reporting groups
96715|NCT01801475|B3|Baseline|Neonates|"Babies of the pregnant women enrolled in the study; no ondansetron is given to babies in this Aim 1 of the study. Babies of pregnant women are not given Ondansetron but are in the study for 24-48 hours."
96716|NCT01801475|B2|Baseline|Non-pregnant Women|"Non-pregnant women scheduled for surgery at Stanford who will be given Ondansetron prior to their surgery as standard-of-care.
Ondansetron: non-pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours."
96717|NCT01801475|B1|Baseline|Pregnant Women|"Full term pregnant women scheduled for Cesarean section and will be given Ondansetron as standard-of-care prior to surgery.
Ondansetron: Pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours."
96718|NCT01801475|P5|Participant Flow|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
96719|NCT01801475|P4|Participant Flow|Non-pregnant Women - 4 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron
96720|NCT01801475|P3|Participant Flow|Non-pregnant Women - 8 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron
96721|NCT01801475|P2|Participant Flow|Ondansetron 8 mg IV - Pregnant|Ondansetron 8 mg was given intravenously prior to delivery of the infant.
96722|NCT01801475|P1|Participant Flow|Ondansetron 4 mg IV - Pregnant|Ondansetron 4 mg was given intravenously prior to delivery of the infant.
96723|NCT01801475|O2|Outcome|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
96724|NCT01801475|O1|Outcome|Women - Pregnant/Non-pregnant|Ondansetron 4 mg or 8mg was given intravenously prior to delivery of her baby in pregnant women and was given to age similar women in the non-pregnant group.
96725|NCT01801475|O2|Outcome|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
96978|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96726|NCT01801475|O1|Outcome|Women - Pregnant/Non-pregnant|Ondansetron 4 mg or 8mg was given intravenously prior to delivery of her baby in pregnant women and was given to age similar women in the non-pregnant group.
96727|NCT01801475|E5|Reported Event|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
96728|NCT01801475|E4|Reported Event|Non-pregnant Women - 4 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron
96729|NCT01801475|E3|Reported Event|Non-pregnant Women - 8 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron
96730|NCT01801475|E2|Reported Event|Ondansetron 8 mg IV - Pregnant|Ondansetron 8 mg was given intravenously prior to delivery of the infant.
96731|NCT01801475|E1|Reported Event|Ondansetron 4 mg IV - Pregnant|Ondansetron 4 mg was given intravenously prior to delivery of the infant.
96732|NCT01801436|B1|Baseline|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96733|NCT01801436|P1|Participant Flow|Bortezomib|Participants received 1.3 milligram per meter square (mg per m^2) of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96734|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96735|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96736|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96737|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96738|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96739|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96740|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96741|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96941|NCT01800968|P2|Participant Flow|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96742|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96743|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96744|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96745|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96746|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96747|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96748|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96749|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96750|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96751|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96752|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96753|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96754|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96755|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96756|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96757|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96758|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96759|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96760|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96761|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96762|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96763|NCT01801436|E1|Reported Event|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
96764|NCT01801358|B7|Baseline|Total|Total of all reporting groups
96765|NCT01801358|B6|Baseline|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96766|NCT01801358|B5|Baseline|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
98615|NCT01788163|B3|Baseline|South Korea|Subjects in South Korea that meet I/E and population criteria
96769|NCT01801358|B2|Baseline|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96770|NCT01801358|B1|Baseline|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96771|NCT01801358|P6|Participant Flow|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96772|NCT01801358|P5|Participant Flow|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96773|NCT01801358|P4|Participant Flow|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96774|NCT01801358|P3|Participant Flow|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96775|NCT01801358|P2|Participant Flow|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96776|NCT01801358|P1|Participant Flow|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96777|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96778|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96779|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96780|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96781|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96782|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96783|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96784|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96785|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96786|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96787|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96788|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96789|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96790|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96791|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96792|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96793|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96794|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96795|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96796|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96797|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96798|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96799|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96800|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96801|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96802|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96803|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
98616|NCT01788163|B2|Baseline|Taiwan|Subjects in Taiwan that meet I/E and population criteria
96804|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96805|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96806|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96807|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96808|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96809|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96810|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96811|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96812|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96813|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96814|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96815|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96816|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96942|NCT01800968|P1|Participant Flow|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96817|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96818|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96819|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96820|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96821|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96822|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96823|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96824|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96825|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96826|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96827|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96828|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96829|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96830|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96831|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96832|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96833|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96834|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96835|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96836|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96837|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96838|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96839|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96840|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96841|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96842|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96843|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96844|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96845|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96846|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96847|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96848|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96849|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
96850|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
96851|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
96852|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
96853|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96854|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96855|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96856|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96857|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96858|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96859|NCT01801358|O1|Outcome|Phase Ib (Dose Escalation)|"For Phase Ib, a minimum of three patients will be entered into each cohort and evaluated for safety (DLTs and any other medically significant event) at the end of Cycle 1.
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96860|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96861|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96862|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96863|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96864|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96865|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96866|NCT01801358|O7|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
96867|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96868|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96869|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96979|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96870|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96871|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96872|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96873|NCT01801358|O7|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
96874|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96875|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96876|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96877|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96878|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96879|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96880|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
96881|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96882|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96883|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96884|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96885|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96886|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96887|NCT01801358|E6|Reported Event|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96888|NCT01801358|E5|Reported Event|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96889|NCT01801358|E4|Reported Event|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96890|NCT01801358|E3|Reported Event|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96891|NCT01801358|E2|Reported Event|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96892|NCT01801358|E1|Reported Event|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
96893|NCT01801280|B5|Baseline|Total|Total of all reporting groups
96894|NCT01801280|B4|Baseline|Sequence D|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
96895|NCT01801280|B3|Baseline|Sequence C|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d."
96896|NCT01801280|B2|Baseline|Sequence B|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d."
96897|NCT01801280|B1|Baseline|Sequence A|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
96925|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96898|NCT01801280|P4|Participant Flow|Sequence D|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
96899|NCT01801280|P3|Participant Flow|Sequence C|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d."
96900|NCT01801280|P2|Participant Flow|Sequence B|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d."
96901|NCT01801280|P1|Participant Flow|Sequence A|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
96902|NCT01801280|O4|Outcome|EC-MPS + PAN|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.
Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.
Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.
Pantoprazole tablet (PAN) once a day in the morning for two weeks."
96903|NCT01801280|O3|Outcome|EC-MPS|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.
Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg."
96904|NCT01801280|O2|Outcome|MMF+PAN|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.
Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.
Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.
Pantoprazole tablet (PAN) once a day in the morning for two weeks."
96905|NCT01801280|O1|Outcome|Mycophenolate Mofetil (MMF)|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.
Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg."
96906|NCT01801280|E4|Reported Event|EC-MPS + PAN|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.
Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.
Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.
Pantoprazole tablet (PAN) once a day in the morning for two weeks."
96907|NCT01801280|E3|Reported Event|EC-MPS|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.
Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg."
96908|NCT01801280|E2|Reported Event|MMF + PAN|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.
Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.
Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.
Pantoprazole tablet (PAN) once a day in the morning for two weeks."
96909|NCT01801280|E1|Reported Event|Mycophenolate Mofetil (MMF)|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.
Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg."
96910|NCT01801124|B1|Baseline|EXPAREL|undiluted EXPAREL 266 mg
96911|NCT01801124|P1|Participant Flow|EXPAREL|undiluted EXPAREL 266 mg
96912|NCT01801124|O1|Outcome|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
96913|NCT01801124|O1|Outcome|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
96914|NCT01801124|E1|Reported Event|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
96915|NCT01801111|B1|Baseline|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96916|NCT01801111|P1|Participant Flow|Alectinib|Participants received alectinib 600 milligrams (mg), capsule, orally, twice daily (BID), continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96917|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96918|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96919|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96920|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96921|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96922|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96923|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96924|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96975|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96926|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96927|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96928|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96929|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96930|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96931|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96932|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96933|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96934|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96935|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96936|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96937|NCT01801111|E1|Reported Event|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
96938|NCT01800968|B3|Baseline|Total|Total of all reporting groups
96939|NCT01800968|B2|Baseline|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96945|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96946|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96947|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96948|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96949|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96950|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96951|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96952|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96953|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96954|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96955|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96956|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96957|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96958|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96959|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96960|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96961|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96962|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96963|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96964|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96965|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96966|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96967|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96968|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96969|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96970|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96971|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96972|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96973|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo"
96974|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96980|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug"
96981|NCT01800968|E2|Reported Event|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous (SQ) daily.
Placebo: Placebo"
96982|NCT01800968|E1|Reported Event|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous (SQ) daily.
Liraglutide: Active Drug"
96983|NCT01800916|B1|Baseline|Overall Study Population|
96984|NCT01800916|P9|Participant Flow|SenSura/Test C/Test B|The subjects first tested SenSura then Coloplast test product C and finally Coloplast test product B
96985|NCT01800916|P8|Participant Flow|SenSura/Test A/Test C|The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product C
96986|NCT01800916|P7|Participant Flow|SenSura/Test A/Test B|The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product B
96987|NCT01800916|P6|Participant Flow|Test C/SenSura/Test A|The subjects first tested Coloplast test product C then SenSura and finally Coloplast test product A
96988|NCT01800916|P5|Participant Flow|Test C/Test B/SenSura|The subjects first tested Coloplast test product C then Coloplast test product A and finally the comparator SenSura
96989|NCT01800916|P4|Participant Flow|Test B/SenSura/Test C|The subjects first tested Coloplast test product A then SenSura and finally Coloplast test product B
96990|NCT01800916|P3|Participant Flow|Test B/SenSura/Test A|The subjects first tested Coloplast test product B then SenSura and finally Coloplast test product A
96991|NCT01800916|P2|Participant Flow|Test A/Test C/SenSura|The subjects first tested Coloplast test product A then Coloplast test product C and finally the comparator SenSura
96992|NCT01800916|P1|Participant Flow|Test A/Test B/SenSura|The subjects first tested Coloplast test product A then Coloplast test product B and finally the comparator SenSura
96993|NCT01800916|O4|Outcome|SenSura|
96994|NCT01800916|O3|Outcome|Test C|
96995|NCT01800916|O2|Outcome|Test B|
96996|NCT01800916|O1|Outcome|Test A|
96997|NCT01800916|E4|Reported Event|SenSura|
97001|NCT01800903|B1|Baseline|All Participants|The intention to treat population consists of 36 healthy male subjects
97002|NCT01800903|P6|Participant Flow|ZN-C Catheter Then ZN-D Catheter Then SpeediCath Catheter|First ZN-C catheter then ZN-D catheter then SpeediCath catheter
97003|NCT01800903|P5|Participant Flow|ZN-C Catheter Then SpeediCath Catheter Then ZN-D Catheter|First ZN-C catheter then SpeediCath catheter then ZN-D catheter
97004|NCT01800903|P4|Participant Flow|ZN-D Catheter Then ZN-C Catheter Then SpeediCath Catheter|First ZN-D catheter then ZN-C catheter then SpeediCath catheter
97005|NCT01800903|P3|Participant Flow|ZN-D Catheter Then SpeediCath Catheter Then ZN-C Catheter|First ZN-D catheter then SpeediCath catheter then ZN-C catheter
97006|NCT01800903|P2|Participant Flow|SpeediCath Catheter Then ZN-C Catheter Then ZN-D Catheter|First SpeediCath catheter then ZN-C catheter then ZN-D catheter
97007|NCT01800903|P1|Participant Flow|SpeediCath Catheter Then ZN-D Catheter Then ZN-C Catheter|First SpeediCath catheter then ZN-D catheter then ZN-C catheter
97008|NCT01800903|O3|Outcome|SpeediCath|Subjects who tested the Speedicath catheter
97009|NCT01800903|O2|Outcome|ZN-C Catheter|Subjects who tested the ZN-C catheter
97010|NCT01800903|O1|Outcome|ZN-D Catheter|Subjects who tested the ZN-D catheter
97011|NCT01800903|E1|Reported Event|All Participants|"Data from subjects in the safety population. Definition of safety population: subjects that have given informed consent and have been exposed to at least one product.
However for 4 of these subjects no endpoint data was obtained and they were not included in the ITT population; they therefore do not appear in the participant flow module."
97012|NCT01800890|B1|Baseline|Overall Study Population|baseline data is given for subjects in the ITT population
97013|NCT01800890|P9|Participant Flow|SenSura/Test C/Test B|The subjects first tested the comparator product SenSura then Coloplast test product C and finally Cololpast test product B
97014|NCT01800890|P8|Participant Flow|SenSura/Test A/Test C|The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product C
97015|NCT01800890|P7|Participant Flow|SenSura/Test A/Test B|The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product B
97016|NCT01800890|P6|Participant Flow|Test C/ SenSura/ Test A|The subjects first tested Coloplast test product C then the comparator SenSura and finally Cololpast test product A
97017|NCT01800890|P5|Participant Flow|Test C/ Test B/ SenSura|The subjects first tested Coloplast test product C then Cololpast test product B and finally the comparator SenSura
97018|NCT01800890|P4|Participant Flow|Test B/ SenSura/ Test C|The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product C
97019|NCT01800890|P3|Participant Flow|Test B/ SenSura/ Test A|The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product A
97020|NCT01800890|P2|Participant Flow|Test A/ Test C/ SenSura|The subjects first tested Coloplast test product A then Cololpast test product C and finally the comparator SenSura
97021|NCT01800890|P1|Participant Flow|Test A/ Test B/ SenSura|The subjects first tested Coloplast test product A then Cololpast test product B and finally the comparator SenSura
97022|NCT01800890|O4|Outcome|SenSura|The comparator
97023|NCT01800890|O3|Outcome|Coloplast Test Product C|new test product
97024|NCT01800890|O2|Outcome|Coloplast Test Product B|new test product
97025|NCT01800890|O1|Outcome|Coloplast Test Product A|new test product
97026|NCT01800890|E4|Reported Event|SenSura|The comparator was the CE-marked product SenSura Click
97027|NCT01800890|E3|Reported Event|Coloplast Test Product C|Coloplast Test product C is a new test product
97028|NCT01800890|E2|Reported Event|Coloplast Test Product B|Coloplast Test product B is a new test product
97029|NCT01800890|E1|Reported Event|Coloplast Test Product A|Coloplast Test product A is a new test product
97030|NCT01800786|B3|Baseline|Total|Total of all reporting groups
97031|NCT01800786|B2|Baseline|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
97032|NCT01800786|B1|Baseline|OSA-CPAP Group|"OSA patient will use CPAP for 3 months
CPAP= continuous positive airway pressure therapy
OSA= obstructive sleep apnea"
97033|NCT01800786|P2|Participant Flow|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
97034|NCT01800786|P1|Participant Flow|OSA-CPAP Group|"OSA patient will use CPAP for 3 months
CPAP= continuous positive airway pressure therapy
OSA= obstructive sleep apnea"
97035|NCT01800786|O2|Outcome|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
97036|NCT01800786|O1|Outcome|OSA-CPAP Group|"OSA patient will use CPAP for 3 months
CPAP= continuous positive airway pressure therapy
OSA= obstructive sleep apnea"
97037|NCT01800786|E2|Reported Event|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
97038|NCT01800786|E1|Reported Event|OSA-CPAP Group|"OSA patient will use CPAP for 3 months
CPAP= continuous positive airway pressure therapy
OSA= obstructive sleep apnea"
97039|NCT01800318|B5|Baseline|Total|Total of all reporting groups
97040|NCT01800318|B4|Baseline|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
97096|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97151|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97041|NCT01800318|B3|Baseline|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
97042|NCT01800318|B2|Baseline|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs. at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
97043|NCT01800318|B1|Baseline|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
97044|NCT01800318|P4|Participant Flow|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
97045|NCT01800318|P3|Participant Flow|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
97085|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97046|NCT01800318|P2|Participant Flow|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
97047|NCT01800318|P1|Participant Flow|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
97048|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
97385|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
97049|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. ."
97050|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. .(b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. .
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
97051|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
97052|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
97053|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. ."
97054|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. .(b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. .
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
97055|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
97056|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
97146|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97057|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
97058|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
97059|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
97060|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
97086|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97087|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97364|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU
No IV acetaminophen"
97061|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
97062|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
97063|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
97064|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
97147|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
97065|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
97066|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
97067|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
97068|NCT01800318|E4|Reported Event|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
97069|NCT01800318|E3|Reported Event|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
97070|NCT01800318|E2|Reported Event|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.
NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.
Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
97071|NCT01800318|E1|Reported Event|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.
Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.
Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
97072|NCT01800162|B4|Baseline|Total|Total of all reporting groups
97073|NCT01800162|B3|Baseline|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.
Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring."
97074|NCT01800162|B2|Baseline|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.
Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
97148|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97075|NCT01800162|B1|Baseline|Uterine Evacuation, Then MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.
Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.
Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
97076|NCT01800162|P3|Participant Flow|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.
Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring."
97077|NCT01800162|P2|Participant Flow|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.
Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
97078|NCT01800162|P1|Participant Flow|Uterine Evacuation, Then MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.
Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.
Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
97079|NCT01800162|O2|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
97080|NCT01800162|O1|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
97081|NCT01800162|E2|Reported Event|Expectant Management|No AE to Report
97082|NCT01800162|E1|Reported Event|Uterine Evacuation|No AE to Report
97083|NCT01799941|B1|Baseline|Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg|Participants who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97084|NCT01799941|P1|Participant Flow|Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg|Participants who received fixed-dose combination of 20 milligram (mg) dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97088|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97089|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97090|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97091|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97092|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97093|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97094|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97095|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97149|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97097|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97098|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97099|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97100|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97101|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97102|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97103|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97104|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97105|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97106|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97107|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97108|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97109|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97110|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97111|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97112|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97113|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97114|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97115|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97116|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97117|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97118|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97150|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
97386|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
97119|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97120|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97121|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97122|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97123|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97124|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97125|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97126|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97127|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97128|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97129|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97130|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97131|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97132|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97133|NCT01799941|E4|Reported Event|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97134|NCT01799941|E3|Reported Event|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97135|NCT01799941|E2|Reported Event|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97136|NCT01799941|E1|Reported Event|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
97137|NCT01799720|B4|Baseline|Total|Total of all reporting groups
97138|NCT01799720|B3|Baseline|Only Diet|Participants from group 3 only received the diet. Follow-up 30 days.
97139|NCT01799720|B2|Baseline|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97140|NCT01799720|B1|Baseline|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97141|NCT01799720|P3|Participant Flow|Diet|Participants from group 3 took only diet, Follow-up 30 days
97142|NCT01799720|P2|Participant Flow|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules a day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
97143|NCT01799720|P1|Participant Flow|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules a day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
97144|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
97145|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97152|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97153|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
97154|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97155|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97156|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
97157|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97158|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97159|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
97160|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97161|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97162|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
97163|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97164|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97165|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
97166|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97167|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97168|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
97169|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97170|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97171|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
97172|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97173|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97174|NCT01799720|E3|Reported Event|Diet|Participants from group 3 only took diet. Follow-up 30 days.
97175|NCT01799720|E2|Reported Event|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97176|NCT01799720|E1|Reported Event|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
97177|NCT01799590|B4|Baseline|Total|Total of all reporting groups
97178|NCT01799590|B3|Baseline|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97179|NCT01799590|B2|Baseline|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97180|NCT01799590|B1|Baseline|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97181|NCT01799590|P3|Participant Flow|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97182|NCT01799590|P2|Participant Flow|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97183|NCT01799590|P1|Participant Flow|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97184|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97185|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97186|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97187|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97188|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97189|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97190|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97191|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97192|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97193|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97194|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97195|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97304|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97196|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97197|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97198|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97199|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97200|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97201|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97202|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97387|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
97388|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
97203|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97204|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97205|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97206|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97207|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97208|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97209|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97210|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97211|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97212|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97213|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97214|NCT01799590|E3|Reported Event|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97215|NCT01799590|E2|Reported Event|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97216|NCT01799590|E1|Reported Event|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
97217|NCT01799239|B1|Baseline|Overall Study|Describing baseline data for all subjects in the ITT population
97218|NCT01799239|P2|Participant Flow|First SenSura, Then Test Product|The subjects tested two products: In the first period the subjects tested the comparator SenSura. In the second period the subjects tested the newly developed ostomy bag called Test product
97219|NCT01799239|P1|Participant Flow|First Test Product; Then SenSura|The subjects tested two products: In the first period the subjects tested the newly developed ostomy bag called Test product. In the second period the subjects tested the comparator SenSura
97220|NCT01799239|O2|Outcome|SenSura|CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
97221|NCT01799239|O1|Outcome|Test Product|The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
97222|NCT01799239|E2|Reported Event|SenSura|CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
97223|NCT01799239|E1|Reported Event|Test Product|The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
97224|NCT01799226|B3|Baseline|Total|Total of all reporting groups
97247|NCT01798992|O3|Outcome|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months
Carvedilol"
97225|NCT01799226|B2|Baseline|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
97226|NCT01799226|B1|Baseline|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
97227|NCT01799226|P2|Participant Flow|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
97228|NCT01799226|P1|Participant Flow|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
97229|NCT01799226|O2|Outcome|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
97230|NCT01799226|O1|Outcome|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
97231|NCT01799226|O2|Outcome|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
97232|NCT01799226|O1|Outcome|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
97233|NCT01799226|E2|Reported Event|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
97335|NCT01798394|B2|Baseline|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
97234|NCT01799226|E1|Reported Event|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
97235|NCT01798992|B5|Baseline|Total|Total of all reporting groups
97236|NCT01798992|B4|Baseline|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months
Carvedilol"
97237|NCT01798992|B3|Baseline|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months
Metoprolol succinate + doxazosin"
97238|NCT01798992|B2|Baseline|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months
Metoprolol succinate"
97239|NCT01798992|B1|Baseline|Non-failing Control|Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy
97240|NCT01798992|P4|Participant Flow|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months
Carvedilol"
97241|NCT01798992|P3|Participant Flow|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months
Metoprolol succinate + doxazosin"
97242|NCT01798992|P2|Participant Flow|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months
Metoprolol succinate"
97243|NCT01798992|P1|Participant Flow|Non-failing Control|Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy
97244|NCT01798992|O3|Outcome|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months
Carvedilol"
97245|NCT01798992|O2|Outcome|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months
Metoprolol succinate + doxazosin"
97246|NCT01798992|O1|Outcome|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months
Metoprolol succinate"
97248|NCT01798992|O2|Outcome|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months
Metoprolol succinate + doxazosin"
97249|NCT01798992|O1|Outcome|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months
Metoprolol succinate"
97250|NCT01798992|O3|Outcome|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months
Carvedilol"
97251|NCT01798992|O2|Outcome|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months
Metoprolol succinate + doxazosin"
97252|NCT01798992|O1|Outcome|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months
Metoprolol succinate"
97253|NCT01798992|E3|Reported Event|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months
Carvedilol"
97254|NCT01798992|E2|Reported Event|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months
Metoprolol succinate + doxazosin"
97255|NCT01798992|E1|Reported Event|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months
Metoprolol succinate"
97256|NCT01798966|B1|Baseline|SENSIMED Triggerfish|All patients included in the device group
97257|NCT01798966|P1|Participant Flow|SENSIMED Triggerfish|All patients included in the device group
97258|NCT01798966|O1|Outcome|SENSIMED Triggerfish|SENSIMED Triggerfish worn for 24h
97259|NCT01798966|O1|Outcome|SENSIMED Triggerfish|All patients included in the device group
97260|NCT01798966|O1|Outcome|SENSIMED Triggerfish|SENSIMED Triggerfish worn for 24h
97261|NCT01798966|E1|Reported Event|SENSIMED Triggerfish|All patients included in the device group
97262|NCT01798927|B1|Baseline|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
97263|NCT01798927|P1|Participant Flow|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
97264|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
97265|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
97266|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
97267|NCT01798927|E1|Reported Event|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
97268|NCT01798706|B3|Baseline|Total|Total of all reporting groups
97269|NCT01798706|B2|Baseline|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97270|NCT01798706|B1|Baseline|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97271|NCT01798706|P2|Participant Flow|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97272|NCT01798706|P1|Participant Flow|Lixisenatide|Lixisenatide 10 mcg subcutaneously once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97273|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97274|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97275|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97276|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97277|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97278|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97279|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97280|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97281|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97282|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97389|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
97284|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97285|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97286|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97287|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97288|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97289|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97290|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97291|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97292|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97293|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
97294|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
97295|NCT01798706|E2|Reported Event|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks. (Median exposure: 169 days)
97296|NCT01798706|E1|Reported Event|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.(Median exposure: 169 days)
97297|NCT01798485|B3|Baseline|Total|Total of all reporting groups
97298|NCT01798485|B2|Baseline|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97299|NCT01798485|B1|Baseline|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97300|NCT01798485|P2|Participant Flow|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97301|NCT01798485|P1|Participant Flow|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97302|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97303|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97305|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97306|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97307|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97308|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97309|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97310|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97311|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97312|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97313|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97314|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97315|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97316|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97345|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
97317|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97318|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97319|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97320|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97321|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97322|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97323|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97324|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97325|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97326|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97327|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97328|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97329|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97330|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97331|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97332|NCT01798485|E2|Reported Event|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
97333|NCT01798485|E1|Reported Event|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
97334|NCT01798394|B3|Baseline|Total|Total of all reporting groups
97336|NCT01798394|B1|Baseline|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
97337|NCT01798394|P2|Participant Flow|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
97338|NCT01798394|P1|Participant Flow|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
97339|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
97340|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
97341|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
97342|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
97343|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
97344|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
97346|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
97347|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
97348|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
97349|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
97350|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
97351|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
97352|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
97353|NCT01798394|E2|Reported Event|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
97354|NCT01798394|E1|Reported Event|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
97355|NCT01798316|B3|Baseline|Total|Total of all reporting groups
97356|NCT01798316|B2|Baseline|Standard of Care|"Standard of care pain management regimen including opioids
Standard of Care: No IV acetaminophen"
97357|NCT01798316|B1|Baseline|IV Acetaminophen|"IV Acetaminophen administered before PACU admission
IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes"
97358|NCT01798316|P2|Participant Flow|Standard of Care|"Standard of care pain management regimen including opioids
Standard of Care: without IV acetaminophen"
97359|NCT01798316|P1|Participant Flow|IV Acetaminophen|"IV Acetaminophen administered before PACU admission
IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes"
97360|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU
No IV Acetaminophen"
97361|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU
IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
97362|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU
No IV Acetaminophen"
97363|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU
IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
97365|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered before PACU admission
IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
97366|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU
No IV Acetaminophen"
97367|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU
IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
97368|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU
No IV acetaminophen"
97369|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered before PACU admission
IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
97370|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU
No IV acetaminophen"
97371|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU
IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
97372|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU
No IV Acetaminophen"
97373|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU
IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
97374|NCT01798316|E2|Reported Event|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU
No IV acetaminophen"
97375|NCT01798316|E1|Reported Event|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU
IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
97376|NCT01798264|B5|Baseline|Total|Total of all reporting groups
97377|NCT01798264|B4|Baseline|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
97378|NCT01798264|B3|Baseline|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
97379|NCT01798264|B2|Baseline|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
97380|NCT01798264|B1|Baseline|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
97381|NCT01798264|P4|Participant Flow|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
97382|NCT01798264|P3|Participant Flow|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
97383|NCT01798264|P2|Participant Flow|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
97401|NCT01798264|E4|Reported Event|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
97402|NCT01798264|E3|Reported Event|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
97403|NCT01798264|E2|Reported Event|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
97404|NCT01798264|E1|Reported Event|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
97405|NCT01798186|B5|Baseline|Total|Total of all reporting groups
97406|NCT01798186|B4|Baseline|Smokers|cannabis smokers
97407|NCT01798186|B3|Baseline|Cannabis 11% THC, Vent|passive exposure to 11% THC cannabis smoke, ventilated room
97408|NCT01798186|B2|Baseline|Cannabis 11% THC, no Vent|passive exposure to 11% THC cannabis smoke, unventilated room
97409|NCT01798186|B1|Baseline|Cannabis 5% THC, no Vent|passive exposure to 5% THC cannabis smoke, unventilated room
97410|NCT01798186|P4|Participant Flow|Active Smokers|Participants that smoked cannabis
97411|NCT01798186|P3|Participant Flow|Cannabis 11% THC, Ventilated|passive exposure to 11% THC cannabis smoke in a room with active air ventilation
97412|NCT01798186|P2|Participant Flow|Cannabis 11% THC, no Ventilation|passive exposure to 11% THC cannabis smoke in an unventilated room
97413|NCT01798186|P1|Participant Flow|Cannabis 5% THC, no Ventilation|passive exposure to 5% THC in an unventilated room
97414|NCT01798186|O3|Outcome|11% THC Cannabis, Ventilated|passive exposure to 11% THC cannabis smoke in ventilated room
97415|NCT01798186|O2|Outcome|11% THC Cannabis Smoke, no Vent|passive exposure to 11% THC cannabis smoke in unventilated room
97416|NCT01798186|O1|Outcome|5%THC, no Vent|passive 5% THC cannabis smoke, no room ventilation
97417|NCT01798186|O3|Outcome|11% THC Cannabis, no Ventilation|passive exposure to 5% THC cannabis smoke, with active room ventilation
97418|NCT01798186|O2|Outcome|11%THC Cannabis, no Ventilation|passive exposure to 11% THC cannabis smoke, no room ventilation
97419|NCT01798186|O1|Outcome|5%THC Cannabis, no Ventilation|passive exposure to 5% THC cannabis smoke, no room ventilation
97420|NCT01798186|O3|Outcome|11% THC Cannabis, Vent|passive exposure to 11% THC cannabis smoke in ventilated room
97421|NCT01798186|O2|Outcome|11% THC Cannabis Smoke, no Vent|passive exposure to 11% THC cannabis smoke in unventilated room
97422|NCT01798186|O1|Outcome|5% THC Cannabis, no Vent|passive exposure to 5%THC cannabis smoke in unventilated room
97423|NCT01798186|E3|Reported Event|11% THC Cannabis Smoke, Ventilation|passive exposure to 11%THC cannabis smoke in ventilated room
97424|NCT01798186|E2|Reported Event|11% THC Cannabis Smoke, no Ventilation|passive exposure to 11%THC cannabis smoke in unventilated room
97425|NCT01798186|E1|Reported Event|5% THC Cannabis Smoke, no Ventilation|passive exposure to 5%THC cannabis smoke in unventilated room
97426|NCT01798134|B1|Baseline|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™"
97427|NCT01798134|P1|Participant Flow|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™"
97428|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™"
97429|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™"
97430|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™"
97431|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™"
97432|NCT01798134|E1|Reported Event|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™"
97433|NCT01798004|B1|Baseline|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
97434|NCT01798004|P1|Participant Flow|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
97435|NCT01798004|O1|Outcome|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel Chemotherapy+ASCT+XRT
97436|NCT01798004|E1|Reported Event|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
97437|NCT01797783|B3|Baseline|Total|Total of all reporting groups
97438|NCT01797783|B2|Baseline|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97439|NCT01797783|B1|Baseline|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97440|NCT01797783|P2|Participant Flow|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97441|NCT01797783|P1|Participant Flow|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97442|NCT01797783|O8|Outcome|FDP @ Day 30|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97443|NCT01797783|O7|Outcome|FDP @ Day 14|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97444|NCT01797783|O6|Outcome|FDP @ Day 3|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97445|NCT01797783|O5|Outcome|FDP @ Dispense|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97446|NCT01797783|O4|Outcome|DACP MF @ Day 30|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97447|NCT01797783|O3|Outcome|DACP MF @ Day 14|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97448|NCT01797783|O2|Outcome|DACP MF @ Day 3|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97449|NCT01797783|O1|Outcome|DACP MF @ Dispense|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97450|NCT01797783|O8|Outcome|FDP @ Day 30|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97451|NCT01797783|O7|Outcome|FDP @ Day 14|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97452|NCT01797783|O6|Outcome|FDP @ Day 3|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97453|NCT01797783|O5|Outcome|FDP @ Dispense|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97454|NCT01797783|O4|Outcome|DACP MF @ Day 30|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97455|NCT01797783|O3|Outcome|DACP MF @ Day 14|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97456|NCT01797783|O2|Outcome|DACP MF @ Day 3|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97457|NCT01797783|O1|Outcome|DACP MF @ Dispense|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97458|NCT01797783|O2|Outcome|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97459|NCT01797783|O1|Outcome|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97460|NCT01797783|E2|Reported Event|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
97461|NCT01797783|E1|Reported Event|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
97462|NCT01797731|B3|Baseline|Total|Total of all reporting groups
97463|NCT01797731|B2|Baseline|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.
Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
97464|NCT01797731|B1|Baseline|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.
Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
97465|NCT01797731|P2|Participant Flow|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.
Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
97466|NCT01797731|P1|Participant Flow|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.
Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
97467|NCT01797731|O2|Outcome|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.
Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
97468|NCT01797731|O1|Outcome|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.
Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
97469|NCT01797731|O2|Outcome|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.
Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
97470|NCT01797731|O1|Outcome|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.
Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
97471|NCT01797731|E2|Reported Event|KneeAlign System|"Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.
Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty"
97472|NCT01797731|E1|Reported Event|Conventional System|"Conventional tibial extramedullary alignment system used by surgeon during surgery.
Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty."
97473|NCT01797705|B1|Baseline|All Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
97474|NCT01797705|P1|Participant Flow|All Subjects|All enrolled subjects
97475|NCT01797705|O1|Outcome|All Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
97476|NCT01797705|E1|Reported Event|Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
97477|NCT01797536|B5|Baseline|Total|Total of all reporting groups
97478|NCT01797536|B4|Baseline|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
97479|NCT01797536|B3|Baseline|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
97480|NCT01797536|B2|Baseline|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
97481|NCT01797536|B1|Baseline|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
97482|NCT01797536|P4|Participant Flow|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
97483|NCT01797536|P3|Participant Flow|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
97484|NCT01797536|P2|Participant Flow|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
97485|NCT01797536|P1|Participant Flow|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
97486|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
97487|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
97488|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
97489|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
97490|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
97491|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
97492|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
97493|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
97494|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
97495|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
97496|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
97497|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
97498|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
97499|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
97500|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
97501|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
97502|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
97503|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
97504|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
97505|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
97506|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
97507|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
97508|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
97509|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
97510|NCT01797536|E4|Reported Event|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
97511|NCT01797536|E3|Reported Event|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
97512|NCT01797536|E2|Reported Event|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
97513|NCT01797536|E1|Reported Event|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
97514|NCT01797445|B3|Baseline|Total|Total of all reporting groups
97515|NCT01797445|B2|Baseline|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97516|NCT01797445|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97517|NCT01797445|P2|Participant Flow|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97518|NCT01797445|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks
97519|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97520|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97521|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97522|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97523|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97524|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97525|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97526|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97527|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97528|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97529|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97530|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97531|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97532|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97533|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97534|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97535|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97536|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97537|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97538|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97539|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97540|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97541|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
98617|NCT01788163|B1|Baseline|China|Subjects in China that meet I/E and population criteria.
97542|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97543|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97544|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97545|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97546|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97547|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97548|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97549|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97550|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97551|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97552|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97553|NCT01797445|E2|Reported Event|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
97554|NCT01797445|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
97555|NCT01797380|B3|Baseline|Total|Total of all reporting groups
97556|NCT01797380|B2|Baseline|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
97557|NCT01797380|B1|Baseline|Sugar Pill|Placebo
97558|NCT01797380|P2|Participant Flow|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
97559|NCT01797380|P1|Participant Flow|Sugar Pill|Placebo
97560|NCT01797380|O2|Outcome|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
97561|NCT01797380|O1|Outcome|Sugar Pill|Placebo
97562|NCT01797380|E2|Reported Event|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
97565|NCT01797328|B2|Baseline|to Avoid Feeling Cold|"warm arm
warm arm: To the best of ability avoid feeling cold during 6 weeks"
97566|NCT01797328|B1|Baseline|Cold Provocation|"cold arm
cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
97567|NCT01797328|P2|Participant Flow|to Avoid Feeling Cold|"warm arm
warm arm: To the best of ability avoid feeling cold during 6 weeks"
97568|NCT01797328|P1|Participant Flow|Cold Provocation|"cold arm
cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
97569|NCT01797328|O2|Outcome|to Avoid Feeling Cold|"warm arm
warm arm: To the best of ability avoid feeling cold during 6 weeks"
97570|NCT01797328|O1|Outcome|Cold Provocation|"cold arm
cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
97571|NCT01797328|E2|Reported Event|to Avoid Feeling Cold|"warm arm
warm arm: To the best of ability avoid feeling cold during 6 weeks"
97572|NCT01797328|E1|Reported Event|Cold Provocation|"cold arm
cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering
no reported adverse events"
97573|NCT01797094|B3|Baseline|Total|Total of all reporting groups
97574|NCT01797094|B2|Baseline|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97575|NCT01797094|B1|Baseline|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97576|NCT01797094|P2|Participant Flow|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97577|NCT01797094|P1|Participant Flow|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97578|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97579|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97580|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97581|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97582|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97812|NCT01794936|P1|Participant Flow|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
97583|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97584|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97585|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97586|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97587|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97588|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97589|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97590|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97591|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97592|NCT01797094|E2|Reported Event|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97593|NCT01797094|E1|Reported Event|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97594|NCT01797081|B5|Baseline|Total|Total of all reporting groups
97595|NCT01797081|B4|Baseline|Placebo/Botulinum Toxin Type A (12 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
97596|NCT01797081|B3|Baseline|Placebo/Botulinum Toxin Type A (24 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
97597|NCT01797081|B2|Baseline|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97598|NCT01797081|B1|Baseline|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97599|NCT01797081|P4|Participant Flow|Placebo/Botulinum Toxin Type A (12 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
97600|NCT01797081|P3|Participant Flow|Placebo/Botulinum Toxin Type A (24 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
97601|NCT01797081|P2|Participant Flow|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97602|NCT01797081|P1|Participant Flow|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97603|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
97604|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97605|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97606|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
98618|NCT01788163|P9|Participant Flow|Russia|Subjects in Russia that meet I/E and population criteria
97607|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97608|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97609|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
97610|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97611|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97612|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
97613|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97614|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97615|NCT01797081|E3|Reported Event|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
97616|NCT01797081|E2|Reported Event|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97617|NCT01797081|E1|Reported Event|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
97618|NCT01797029|B3|Baseline|Total|Total of all reporting groups
97619|NCT01797029|B2|Baseline|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
97620|NCT01797029|B1|Baseline|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
97621|NCT01797029|P2|Participant Flow|Placebo|Inactive placebo will be identical to reconstituted Serum Institute of India, Ltd. (SIIL) LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
97622|NCT01797029|P1|Participant Flow|Vaccine|A single dose of Serum Institute of India, Ltd. (SIIL) Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
97623|NCT01797029|O2|Outcome|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
97624|NCT01797029|O1|Outcome|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
97625|NCT01797029|O2|Outcome|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
97626|NCT01797029|O1|Outcome|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
97627|NCT01797029|E2|Reported Event|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
97628|NCT01797029|E1|Reported Event|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
97629|NCT01796977|B1|Baseline|OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
Standard Gauze Dressing: A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Each study participant was supposed to act as her own control (one breast to be treated with the test article, the other breast with the control article)."
97630|NCT01796977|P1|Participant Flow|OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
Standard Gauze Dressing: A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Each study participant acted as her own control (one breast of each participant was treated with OxyGenesys, while the other breast was treated with the standard dressing (control))."
97631|NCT01796977|O2|Outcome|Standard Gauze Dressing|A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
97632|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
97633|NCT01796977|O1|Outcome|All Available Study Participants|Each study participant was treated with OxyGenesys Dissolved Oxygen Dressing on one breast and standard gauze dressing on the opposite breast.
97634|NCT01796977|O2|Outcome|Standard Gauze Dressing|A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
97635|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
97636|NCT01796977|O2|Outcome|Standard Gauze Dressing|"A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Standard Gauze Dressing"
97637|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
OxyGenesys Dissolved Oxygen Dressing"
97638|NCT01796977|E2|Reported Event|Standard Gauze Dressing|"A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Standard Gauze Dressing"
97639|NCT01796977|E1|Reported Event|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
OxyGenesys Dissolved Oxygen Dressing"
97640|NCT01796964|B3|Baseline|Total|Total of all reporting groups
97641|NCT01796964|B2|Baseline|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
97642|NCT01796964|B1|Baseline|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
97643|NCT01796964|P2|Participant Flow|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
97644|NCT01796964|P1|Participant Flow|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
97645|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
97646|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
97647|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
97648|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
97649|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
97650|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
97651|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
97652|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
97653|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
97654|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
97655|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
97656|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
97657|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
97658|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
97659|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
97660|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
97661|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
97662|NCT01796964|E3|Reported Event|EYLEA|All subjects who were randomized and received at least 1 IVT injection of Aflibercept
97663|NCT01796964|E2|Reported Event|ESBA 1008|All subjects who were randomized and received at least 1 IVT injection of ESBA1008 solution
97664|NCT01796964|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study
97665|NCT01796860|B1|Baseline|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).
AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
97666|NCT01796860|P1|Participant Flow|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).
AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
97667|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).
AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
97668|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).
AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
97669|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).
AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
97670|NCT01796860|E1|Reported Event|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).
AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
98679|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
97671|NCT01796548|B1|Baseline|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment. 'Number of participants analyzed for the baseline characteristic was intent-to-treat (ITT) population which included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.'
97672|NCT01796548|P1|Participant Flow|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
97673|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
97674|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
97675|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
97676|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
97709|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment F."
97677|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
97678|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
97679|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
97680|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
97681|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
97682|NCT01796548|E1|Reported Event|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
97683|NCT01796236|B3|Baseline|Total|Total of all reporting groups
97684|NCT01796236|B2|Baseline|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant
Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
97685|NCT01796236|B1|Baseline|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.
Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
97686|NCT01796236|P2|Participant Flow|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant
Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
97813|NCT01794936|O1|Outcome|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
97687|NCT01796236|P1|Participant Flow|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.
Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
97688|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant
Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
97689|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.
Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
97690|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant
Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
97691|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.
Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
97692|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant
Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
97693|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.
Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
97710|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment E."
98084|NCT01791725|E1|Reported Event|ELND005 BID|"ELND005 250 mg BID
ELND005"
97694|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant
Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
97695|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.
Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
97696|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant
Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
97697|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.
Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
97698|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant
Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
97699|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no softtissue reduction around the BA400 implant.
Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments)."
97700|NCT01796236|E2|Reported Event|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant
Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
97701|NCT01796236|E1|Reported Event|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.
Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
97702|NCT01795937|B4|Baseline|Total|Total of all reporting groups
97703|NCT01795937|B3|Baseline|Treatment Sequence E_F (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.
Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment E preceded treatment F.
Oral administration with 240 mL water."
97704|NCT01795937|B2|Baseline|Treatment Sequence C_D (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.
Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment C preceded treatment D.
Oral administration with 240 mL water."
97705|NCT01795937|B1|Baseline|Treatment Sequence A_B (Itraconazole Part)|"The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.
Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).
Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment A directly preceded treatment B, without an intermittent washout period.
Oral administration with 240 mL water."
97706|NCT01795937|P3|Participant Flow|Treatment Sequence E_F (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.
Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment E preceded treatment F.
Oral administration with 240 mL water."
97707|NCT01795937|P2|Participant Flow|Treatment Sequence C_D (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.
Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment C preceded treatment D.
Oral administration with 240 mL water."
97708|NCT01795937|P1|Participant Flow|Treatment Sequence A_B (Itraconazole Part)|"The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.
Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).
Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment A directly preceded treatment B, without an intermittent washout period.
Oral administration with 240 mL water."
98085|NCT01791491|B1|Baseline|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
97711|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment F."
97712|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment E."
97713|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment F."
97714|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment E."
97715|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment D."
97716|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment C."
97717|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment F."
97718|NCT01795937|O1|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment D."
97719|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment F."
97720|NCT01795937|O1|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment D."
97721|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment D."
97722|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment C."
97723|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment D."
97724|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment C."
97725|NCT01795937|O2|Outcome|Faldaprevir+Itraconazole|"Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B."
97726|NCT01795937|O1|Outcome|Faldaprevir|"Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A."
97727|NCT01795937|O2|Outcome|Faldaprevir+Itraconazole|"Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B."
97728|NCT01795937|O1|Outcome|Faldaprevir|"Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A."
97814|NCT01794936|O1|Outcome|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
97815|NCT01794936|E1|Reported Event|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
97729|NCT01795937|E7|Reported Event|Faldaprevir + Rosuvastatin (Statins Part)|"Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Rosuvastatin: 10 mg was given as a single dose on Day 1.
Treatment F.
From the time of the combined administration of faldaprevir with rosuvastatin in treatment F until 1 day after the trial completion date."
97730|NCT01795937|E6|Reported Event|Faldaprevir + Atorvastatin (Statins Part)|"Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Atorvastatin: 10 mg was given as a single dose on Day 1.
Treatment D.
From the time of the combined administration of faldaprevir with atorvastatin in treatment D until 1 day after the trial completion date."
97731|NCT01795937|E5|Reported Event|Faldaprevir (Statins Part)|From the time of the first faldaprevir administration in treatment D or F until the combined administration of faldaprevir with atorvastatin or rosuvastatin in treatment D or F, respectively, or until 1 day after the trial completion date.
97732|NCT01795937|E4|Reported Event|Rosuvastatin (Statins Part)|"Rosuvastatin: 10 mg was given as a single dose on Day 1.
Treatment E.
From the time of the single dose rosuvastatin administration in treatment E until the time of the first faldaprevir administration in treatment F or until 1 day after the trial completion date."
97733|NCT01795937|E3|Reported Event|Atorvastatin (Statins Part)|"Atorvastatin: 10 mg was given as a single dose on Day 1.
Treatment C.
From the time of the single dose atorvastatin administration in treatment C until the time of the first faldaprevir administration in treatment D or until 1 day after the trial completion date of the respective subject."
97734|NCT01795937|E2|Reported Event|Faldaprevir+Itraconazole (Itraconazole Part)|"Faldaprevir: 120 mg once daily. Itraconazole: 200 mg once daily with a 200 mg twice daily loading dose on Day -3.
Treatment B."
97735|NCT01795937|E1|Reported Event|Faldaprevir (Itraconazole Part)|"Faldaprevir: 120 mg once daily with a 120 mg twice daily loading dose on Day -5.
Treatment A."
97736|NCT01795898|B1|Baseline|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
97737|NCT01795898|P1|Participant Flow|Fentanyl|Fentanyl transdermal (through the skin) patches releasing 12.5 microgram (mcg) of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
97738|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
97739|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
97740|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
97741|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
97742|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
97743|NCT01795898|E1|Reported Event|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
97744|NCT01795859|B3|Baseline|Total|Total of all reporting groups
97745|NCT01795859|B2|Baseline|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
97746|NCT01795859|B1|Baseline|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
97747|NCT01795859|P2|Participant Flow|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
97748|NCT01795859|P1|Participant Flow|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
97749|NCT01795859|O2|Outcome|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
97750|NCT01795859|O1|Outcome|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
97751|NCT01795859|O2|Outcome|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
97752|NCT01795859|O1|Outcome|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
97753|NCT01795859|O2|Outcome|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
97754|NCT01795859|O1|Outcome|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
97755|NCT01795859|O2|Outcome|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
97756|NCT01795859|O1|Outcome|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
97757|NCT01795859|O2|Outcome|SD-809 Placebo|Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
97758|NCT01795859|O1|Outcome|SD-809 Tablets|SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
97759|NCT01795859|E2|Reported Event|SD-809|SD-809
97760|NCT01795859|E1|Reported Event|Placebo|Placebo
97761|NCT01795716|B3|Baseline|Total|Total of all reporting groups
97762|NCT01795716|B2|Baseline|Glivec First, Then Mesylate Imatinib Capsule|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
98619|NCT01788163|P8|Participant Flow|Indonesia|Subjects in Indonesia that meet I/E and population criteria
97763|NCT01795716|B1|Baseline|Mesylate Imatinib Capsule First, Then Glivec|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period. In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
97764|NCT01795716|P2|Participant Flow|Glivec First, Then Mesylate Imatinib Capsule|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
97765|NCT01795716|P1|Participant Flow|Mesylate Imatinib Capsule First, Then Glivec|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period.In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
97766|NCT01795716|O2|Outcome|Glivec|Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
97767|NCT01795716|O1|Outcome|Mesylate Imatinib Capsule|Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
97768|NCT01795716|E2|Reported Event|Glivec|Subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
97769|NCT01795716|E1|Reported Event|Mesylate Imatinib Capsule|Subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
97770|NCT01795547|B3|Baseline|Total|Total of all reporting groups
97771|NCT01795547|B2|Baseline|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
97772|NCT01795547|B1|Baseline|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
97773|NCT01795547|P2|Participant Flow|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
97774|NCT01795547|P1|Participant Flow|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
97775|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
97776|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
97777|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
97778|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
97779|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
97780|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
97781|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
97782|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
97783|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
97784|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
97785|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
97840|NCT01794741|P1|Participant Flow|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months
Dymista Nasal Spray"
97841|NCT01794741|O2|Outcome|Fluticasone Nasal Spray|
97786|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
97787|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
97788|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
97789|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
97790|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
97791|NCT01795547|O2|Outcome|Paliperidone|Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
97792|NCT01795547|O1|Outcome|Aripiprazole|Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
97793|NCT01795547|E2|Reported Event|PALIPERIDONE|Safety data is based on all patients who received study medicine.
97794|NCT01795547|E1|Reported Event|ARIPIPRAZOLE|Safety data is based on all patients who received study medicine.
97795|NCT01795534|B1|Baseline|All Participants|Includes groups randomized to receive beetroot shot first and placebo first.
97796|NCT01795534|P2|Participant Flow|Placebo Shot Then Beetroot Shot|"Intervention: participants will first consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)
Following a four day wash out, participants will then consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
97797|NCT01795534|P1|Participant Flow|Beetroot Shot Then Placebo Shot|"Intervention: Participants will first consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).
Following a four day wash out, participants will then consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)"
97798|NCT01795534|O2|Outcome|Placebo Shot|"Includes groups randomized to receive beetroot first and placebo first.
Data is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)."
97799|NCT01795534|O1|Outcome|Beetroot Shot|"Includes groups randomized to receive beetroot first and placebo first.
Data is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
97800|NCT01795534|E2|Reported Event|Placebo Shot|Data is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK).
97801|NCT01795534|E1|Reported Event|Beetroot Shot|Data is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).
97802|NCT01794949|B3|Baseline|Total|Total of all reporting groups
97803|NCT01794949|B2|Baseline|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
97804|NCT01794949|B1|Baseline|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
97805|NCT01794949|P2|Participant Flow|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
97806|NCT01794949|P1|Participant Flow|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
97807|NCT01794949|O2|Outcome|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
97808|NCT01794949|O1|Outcome|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
97809|NCT01794949|E2|Reported Event|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
97810|NCT01794949|E1|Reported Event|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
97811|NCT01794936|B1|Baseline|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
97842|NCT01794741|O1|Outcome|Dymista Nasal Spray|
97816|NCT01794845|B1|Baseline|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
97817|NCT01794845|P1|Participant Flow|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
97818|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
97819|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
97820|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
97821|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
97858|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.
Candesartan: 4mg - 32mg daily"
97822|NCT01794845|E1|Reported Event|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
97823|NCT01794806|B3|Baseline|Total|Total of all reporting groups
97824|NCT01794806|B2|Baseline|Tooth Extraction|"Tooth extraction
Tooth extraction: Minimally traumatic single-rooted tooth extraction"
97825|NCT01794806|B1|Baseline|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft
Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
97826|NCT01794806|P2|Participant Flow|Tooth Extraction|"Tooth extraction
Tooth extraction: Minimally traumatic single-rooted tooth extraction"
97827|NCT01794806|P1|Participant Flow|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft
Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
97828|NCT01794806|O2|Outcome|Tooth Extraction|"Tooth extraction
Tooth extraction: Minimally traumatic single-rooted tooth extraction"
97829|NCT01794806|O1|Outcome|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft
Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
97830|NCT01794806|O2|Outcome|Tooth Extraction|"Tooth extraction
Tooth extraction: Minimally traumatic single-rooted tooth extraction"
97831|NCT01794806|O1|Outcome|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft
Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
97832|NCT01794806|O2|Outcome|Tooth Extraction|"Tooth extraction
Tooth extraction: Minimally traumatic single-rooted tooth extraction"
97833|NCT01794806|O1|Outcome|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft
Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
97834|NCT01794806|E2|Reported Event|Tooth Extraction|"Tooth extraction
Tooth extraction: Minimally traumatic single-rooted tooth extraction"
97835|NCT01794806|E1|Reported Event|Tooth Extraction and Grafting|"Tooth extraction and grafting with allograft
Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane"
97836|NCT01794741|B3|Baseline|Total|Total of all reporting groups
97837|NCT01794741|B2|Baseline|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day
Fluticasone propionate nasal spray"
97838|NCT01794741|B1|Baseline|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months
Dymista Nasal Spray"
97839|NCT01794741|P2|Participant Flow|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day
Fluticasone propionate nasal spray"
97843|NCT01794741|E2|Reported Event|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day
Fluticasone propionate nasal spray"
97844|NCT01794741|E1|Reported Event|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months
Dymista Nasal Spray"
97845|NCT01794455|B3|Baseline|Total|Total of all reporting groups
97846|NCT01794455|B2|Baseline|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.
Candesartan: 4mg - 32mg daily"
97847|NCT01794455|B1|Baseline|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.
Sertraline: 50mg - 200mg daily"
97848|NCT01794455|P2|Participant Flow|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.
Candesartan: 4mg - 32mg daily"
97849|NCT01794455|P1|Participant Flow|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.
Sertraline: 50mg - 200mg daily"
97850|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.
Candesartan: 4mg - 32mg daily"
97851|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.
Sertraline: 50mg - 200mg daily"
97852|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.
Candesartan: 4mg - 32mg daily"
97853|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.
Sertraline: 50mg - 200mg daily"
97854|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.
Candesartan: 4mg - 32mg daily"
97855|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.
Sertraline: 50mg - 200mg daily"
97856|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.
Candesartan: 4mg - 32mg daily"
97857|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.
Sertraline: 50mg - 200mg daily"
97859|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.
Sertraline: 50mg - 200mg daily"
97860|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.
Candesartan: 4mg - 32mg daily"
97861|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.
Sertraline: 50mg - 200mg daily"
97862|NCT01794455|E2|Reported Event|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.
Candesartan: 4mg - 32mg daily"
97863|NCT01794455|E1|Reported Event|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.
Sertraline: 50mg - 200mg daily"
97864|NCT01794000|B3|Baseline|Total|Total of all reporting groups
97865|NCT01794000|B2|Baseline|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97866|NCT01794000|B1|Baseline|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97867|NCT01794000|P2|Participant Flow|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97868|NCT01794000|P1|Participant Flow|Prasugrel|Participants (Pts.) will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97869|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97870|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97871|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97872|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97873|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97874|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97875|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97876|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97877|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97878|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97879|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97880|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97881|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97882|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97883|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97929|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
97884|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97885|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97886|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97887|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97888|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97889|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97890|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97891|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97892|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97893|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97894|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97895|NCT01794000|E3|Reported Event|Prasugrel - Open Label Phase|Participants who continued to meet eligibility criteria, who were not permanently discontinued from study drug, and who concluded their participation in 24 months of double blind treatment were to be considered eligible to enter the open label phase.
97896|NCT01794000|E2|Reported Event|Placebo - Double Blind Phase|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
97897|NCT01794000|E1|Reported Event|Prasugrel - Double Blind Phase|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
97898|NCT01793688|B1|Baseline|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
97899|NCT01793688|P1|Participant Flow|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
97900|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
97901|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
97902|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
97903|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
97930|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
97931|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
97932|NCT01792986|E1|Reported Event|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
97904|NCT01793688|E1|Reported Event|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
97905|NCT01793285|B1|Baseline|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97906|NCT01793285|P1|Participant Flow|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 milligram (mg) weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97907|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97908|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97909|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97910|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97911|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97912|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97913|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97914|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97915|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97916|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
98620|NCT01788163|P7|Participant Flow|Malaysia|Subjects in Malaysia that meet I/E and population criteria
97917|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97918|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97919|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97920|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97921|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97922|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97923|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97924|NCT01793285|E1|Reported Event|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
97925|NCT01792986|B1|Baseline|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
97926|NCT01792986|P1|Participant Flow|Water-only 24-hour Fasting Once Per Week for 6 Weeks|water-only 24-hour fasting once per week for 6 weeks
97927|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
97928|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
97934|NCT01792830|B7|Baseline|Diabetic/ Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
97935|NCT01792830|B6|Baseline|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
97936|NCT01792830|B5|Baseline|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
97937|NCT01792830|B4|Baseline|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen.
97938|NCT01792830|B3|Baseline|No Diabetes/ Insulin|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin.
97939|NCT01792830|B2|Baseline|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
97940|NCT01792830|B1|Baseline|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C level <7% not requiring subcutaneous insulin, will be discharged from the hospital without any antidiabetic therapy.
97941|NCT01792830|P7|Participant Flow|Diabetic/Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
97942|NCT01792830|P6|Participant Flow|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
97943|NCT01792830|P5|Participant Flow|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
97944|NCT01792830|P4|Participant Flow|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen.
97945|NCT01792830|P3|Participant Flow|No Diabetes Insulin Group|Patients with an HbA1c < 7% and persistent hyperglycemia will be given subcutaneous (SC) insulin therapy in the hospital will be discharged on oral metformin.
97946|NCT01792830|P2|Participant Flow|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
97947|NCT01792830|P1|Participant Flow|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c level <7% not requiring subcutaneous insulin, were discharged from the hospital without any antidiabetic therapy.
98110|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
97948|NCT01792830|O10|Outcome|Diabetic HbA1C >9% Glulisine|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin will be discharged on glulisine, a rapid-acting insulin to be taken before meals.
97949|NCT01792830|O9|Outcome|Diabetic HbA1C >9% Metformin + IInsulin|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C > 9% will be discharged on oral metformin and glargine insulin to be taken daily at the same time of day; or, basal bolus insulin regimen.
97950|NCT01792830|O8|Outcome|Diabetic HbA1C 7%-9% Glargine|Patients with HbA1C between 7% and 9% requiring subcutaneous insulin therapy will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose given once a day at the same time every day.
97951|NCT01792830|O7|Outcome|Diabetic HbA1C 7%-9% Metformin + Glargine|Patients treated with combination of oral antidiabetic agents and basal insulin (NPH, glargine, detemir) prior to admission will be discharged on pre-admission oral antidiabetic therapy plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose.
97952|NCT01792830|O6|Outcome|Diabetic HbA1C 7%- 9% Metformin|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin will be discharged on oral metformin and a single dose of glargine at 50% of total daily hospital dose. Metformin is given in divided doses with meals.
97953|NCT01792830|O5|Outcome|Diabetic HbA1C <7% Glargine|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).
Metformin: Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient. Treatment naïve patients with an HbA1C between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin."
97976|NCT01792635|B2|Baseline|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97977|NCT01792635|B1|Baseline|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
97954|NCT01792830|O4|Outcome|Diabetic HbA1C <7% Metformin|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).
Metformin: Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient.
Patients without a history of diabetes and admission HbA1C < 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy.
Treatment naïve patients with an HbA1C between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin."
97955|NCT01792830|O3|Outcome|No Diabetes Insulin Group|Patients with an A1C < 7% and persistent hyperglycemia requiring SC insulin therapy in the hospital were discharged on oral metformin.
97956|NCT01792830|O2|Outcome|No Diabetes, Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
97957|NCT01792830|O1|Outcome|Control HbA1C < 7%|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C <7% not requiring subcutaneous insulin in the hospital will be discharged on no antidiabetic therapy.
97958|NCT01792830|O10|Outcome|Diabetic HbA1C >9% Glulisine|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin were discharged on glulisine, a rapid-acting insulin taken before meals.
97959|NCT01792830|O9|Outcome|Diabetic HbA1C >9% Metformin + Insulin|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C > 9% were discharged on oral metformin and glargine insulin taken daily at the same time of day; or, basal bolus insulin regimen.
97960|NCT01792830|O8|Outcome|Diabetic HbA1C 7%-9% Glargine|Patients with HbA1C between 7% and 9% requiring subcutaneous insulin therapy were discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose given once a day at the same time every day.
97961|NCT01792830|O7|Outcome|Diabetic HbA1C 7%-9% Metformin + Glargine|Patients treated with combination of oral antidiabetic agents and basal insulin (NPH, glargine, detemir) prior to admission were discharged on pre-admission oral antidiabetic therapy plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose.
97962|NCT01792830|O6|Outcome|Diabetic HbA1C 7%- 9% Metformin|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin were discharged on oral metformin and a single dose of glargine at 50% of total daily hospital dose. Metformin was given in divided doses with meals.
97963|NCT01792830|O5|Outcome|Diabetic HbA1C <7% Glargine|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% were discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).
During treatment initiation and dose titration, the patient's blood glucose levels were used to determine the therapeutic response to glargine and identify the minimum effective dose for the patient. Glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar levels."
97991|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
98621|NCT01788163|P6|Participant Flow|Singapore|Subjects in Singapore that meet I/E and population criteria
97964|NCT01792830|O4|Outcome|Diabetic HbA1C <7% Metformin|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% were discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).
Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels were used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient."
97965|NCT01792830|O3|Outcome|No Diabetes Insulin Group|Patients with an A1C < 7% and persistent hyperglycemia requiring SC insulin therapy in the hospital were discharged on oral metformin.
97966|NCT01792830|O2|Outcome|No Diabetes, Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% were discharged on oral metformin.
97967|NCT01792830|O1|Outcome|Control HbA1C < 7%|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C <7% not requiring subcutaneous insulin in the hospital were discharged on no antidiabetic therapy.
97968|NCT01792830|E6|Reported Event|Diabetic/ Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
97969|NCT01792830|E5|Reported Event|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
97970|NCT01792830|E4|Reported Event|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
97971|NCT01792830|E3|Reported Event|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen.
97972|NCT01792830|E2|Reported Event|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
97973|NCT01792830|E1|Reported Event|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c level <7% not requiring subcutaneous insulin, will be discharged from the hospital without any antidiabetic therapy.
97974|NCT01792635|B4|Baseline|Total|Total of all reporting groups
97975|NCT01792635|B3|Baseline|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
98068|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD
ELND005"
97978|NCT01792635|P3|Participant Flow|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97979|NCT01792635|P2|Participant Flow|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97980|NCT01792635|P1|Participant Flow|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
97981|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97982|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97983|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97984|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97985|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97986|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97987|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97988|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97989|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97990|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
98109|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
97992|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97993|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97994|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97995|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97996|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
97997|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
97998|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
97999|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
98000|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
98069|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID
ELND005"
98001|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
98002|NCT01792635|E3|Reported Event|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
98003|NCT01792635|E2|Reported Event|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
98004|NCT01792635|E1|Reported Event|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
98005|NCT01792518|B3|Baseline|Total|Total of all reporting groups
98006|NCT01792518|B2|Baseline|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98007|NCT01792518|B1|Baseline|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98008|NCT01792518|P2|Participant Flow|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98009|NCT01792518|P1|Participant Flow|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98010|NCT01792518|O2|Outcome|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98011|NCT01792518|O1|Outcome|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98012|NCT01792518|O2|Outcome|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98013|NCT01792518|O1|Outcome|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98014|NCT01792518|O2|Outcome|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98015|NCT01792518|O1|Outcome|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98016|NCT01792518|E2|Reported Event|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98017|NCT01792518|E1|Reported Event|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
98018|NCT01791972|B3|Baseline|Total|Total of all reporting groups
98019|NCT01791972|B2|Baseline|Placebo Spiromax / Albuterol Spiromax|Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
98020|NCT01791972|B1|Baseline|Albuterol Spiromax / Placebo Spiromax|Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
98021|NCT01791972|P2|Participant Flow|Placebo Spiromax / Albuterol Spiromax|Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
98022|NCT01791972|P1|Participant Flow|Albuterol Spiromax / Placebo Spiromax|Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
98023|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
98024|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
98025|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
98026|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
98027|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
98028|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
98029|NCT01791972|E2|Reported Event|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
98030|NCT01791972|E1|Reported Event|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
98031|NCT01791894|B1|Baseline|Treatment (Arsenic Trioxide)|arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days
98032|NCT01791894|P1|Participant Flow|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
98033|NCT01791894|O1|Outcome|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
98034|NCT01791894|O1|Outcome|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
98035|NCT01791894|O1|Outcome|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
arsenic trioxide: Given IV
laboratory biomarker analysis: Correlative studies"
98036|NCT01791894|O1|Outcome|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
arsenic trioxide: Given IV
laboratory biomarker analysis: Correlative studies"
98037|NCT01791894|E1|Reported Event|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
arsenic trioxide: Given IV"
98038|NCT01791803|B5|Baseline|Total|Total of all reporting groups
98039|NCT01791803|B4|Baseline|Self-Quit Group|Patients were given brief counseling during hospitalization and were not contacted until 26 weeks after hospitalization. They received no telephone contact and or counseling after discharge.
98040|NCT01791803|B3|Baseline|Hypnotherapy and Nicotine Replacement|patients recieved both a similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.
98041|NCT01791803|B2|Baseline|Nicotine Replacement Therapy|Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays, self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.
98042|NCT01791803|B1|Baseline|Hypnotherapy|Patients received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use . They also received counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.
98043|NCT01791803|P4|Participant Flow|Self-Quit Group|patients will be given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
98044|NCT01791803|P3|Participant Flow|Hypnotherapy and Nicotine Replacement|"The group will recieve similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.
hypnotherapy: One 90 minute session within 2 weeks of hospital discharge
Nicotine: free one month supply after hospital discharge"
98045|NCT01791803|P2|Participant Flow|Nicotine Replacement Therapy|"Patients will recieve a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients will receive self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.
Nicotine: free one month supply after hospital discharge"
98046|NCT01791803|P1|Participant Flow|Hypnotherapy|"Patients admitted with a cardiopulmonary illness will receive a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.
hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
98047|NCT01791803|O1|Outcome|Smoking Abstinence Rates at 12 and 26 Weeks|Smoking status at follow-up time at 12 and 26 weeks by diagnosis status (cardiac vs. pulmonary)
98048|NCT01791803|O4|Outcome|Self-Quit Group|patients were given brief counseling during hospitalization and were not be contacted until 26 weeks after hospitalization.
98049|NCT01791803|O3|Outcome|Hypnotherapy and Nicotine Replacement|"The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.
hypnotherapy: One 90 minute session within 2 weeks of hospital discharge
Nicotine: free one month supply after hospital discharge"
98050|NCT01791803|O2|Outcome|Nicotine Replacement Therapy|"Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.
Nicotine: free one month supply after hospital discharge"
98051|NCT01791803|O1|Outcome|Hypnotherapy|"Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.
hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
98052|NCT01791803|O4|Outcome|Self-Quit Group|patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
98053|NCT01791803|O3|Outcome|Hypnotherapy and Nicotine Replacement|"The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.
hypnotherapy: One 90 minute session within 2 weeks of hospital discharge
Nicotine: free one month supply after hospital discharge"
98054|NCT01791803|O2|Outcome|Nicotine Replacement Therapy|"Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.
Nicotine: free one month supply after hospital discharge"
98055|NCT01791803|O1|Outcome|Hypnotherapy|"Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.
hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
98056|NCT01791803|E4|Reported Event|Self-Quit Group|patient who decided to quit on their own
98057|NCT01791803|E3|Reported Event|Hypnotherapy and Nicotine Replacement|Patients receiving hypnotherapy and nicotine supply
98058|NCT01791803|E2|Reported Event|Nicotine Replacement Therapy|Patients receiving a free months supply of nicotine
98059|NCT01791803|E1|Reported Event|Hypnotherapy|patients receiving a free intensive session of hypnotherapy within 2 weeks of hospitalization
98060|NCT01791725|B4|Baseline|Total|Total of all reporting groups
98061|NCT01791725|B3|Baseline|Placebo|"Placebo BID
Placebo"
98062|NCT01791725|B2|Baseline|ELND005 QD|"ELND005 250 mg QD
ELND005"
98063|NCT01791725|B1|Baseline|ELND005 BID|"ELND005 250 mg BID
ELND005"
98064|NCT01791725|P3|Participant Flow|Placebo|"Placebo BID
Placebo"
98065|NCT01791725|P2|Participant Flow|ELND005 QD|"ELND005 250 mg QD
ELND005"
98066|NCT01791725|P1|Participant Flow|ELND005 BID|"ELND005 250 mg BID
ELND005"
98067|NCT01791725|O3|Outcome|Placebo|"Placebo BID
Placebo"
98086|NCT01791491|P1|Participant Flow|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
98087|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
98088|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
98089|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
98090|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
98091|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
98092|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
98093|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
98094|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
98095|NCT01791491|O1|Outcome|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
98096|NCT01791491|E1|Reported Event|Belatacept|A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes.
98097|NCT01791465|B1|Baseline|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide
98098|NCT01791465|P1|Participant Flow|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98099|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98100|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98101|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98102|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98103|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98104|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98105|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98106|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98107|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98108|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98111|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98112|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98113|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98114|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98115|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98116|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98117|NCT01791465|O1|Outcome|Bydureon Treatment|"Treatment for 16 weeks with extended-release Exenatide (Bydureon)
extended-release exenatide: Single arm study - 2mg Bydureon every 7 days x 16 weeks"
98118|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98119|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98120|NCT01791465|E1|Reported Event|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
98121|NCT01791413|B3|Baseline|Total|Total of all reporting groups
98122|NCT01791413|B2|Baseline|Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
98123|NCT01791413|B1|Baseline|No Depot Medroxyprogesterone Acetate|
98124|NCT01791413|P2|Participant Flow|Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
98125|NCT01791413|P1|Participant Flow|No Depot Medroxyprogesterone Acetate|
98126|NCT01791413|O4|Outcome|3 mo. Post op: Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation
98127|NCT01791413|O3|Outcome|3 mo. Post op: No Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation
98128|NCT01791413|O2|Outcome|2 wk Post op:Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation
98129|NCT01791413|O1|Outcome|2 wk Post op : No Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation
98130|NCT01791413|E1|Reported Event|DMPA|
98131|NCT01791244|B3|Baseline|Total|Total of all reporting groups
98132|NCT01791244|B2|Baseline|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98133|NCT01791244|B1|Baseline|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98134|NCT01791244|P2|Participant Flow|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98135|NCT01791244|P1|Participant Flow|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98136|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98137|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98138|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98139|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98140|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98141|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98142|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98143|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98144|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98145|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98146|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98147|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98148|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98149|NCT01791244|O1|Outcome|Patient Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98150|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98268|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98700|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
98151|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98152|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98153|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98154|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98155|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98156|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98157|NCT01791244|O1|Outcome|Patient Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98158|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98159|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98160|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98161|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98162|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98163|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98164|NCT01791244|O2|Outcome|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98165|NCT01791244|O1|Outcome|Subject Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98166|NCT01791244|E2|Reported Event|Technical Support for the RebiSmart™ Device|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
98167|NCT01791244|E1|Reported Event|Patient Support Program (MinSupport Plus)|Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
98168|NCT01791205|B3|Baseline|Total|Total of all reporting groups
98169|NCT01791205|B2|Baseline|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98170|NCT01791205|B1|Baseline|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98171|NCT01791205|P2|Participant Flow|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98269|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98172|NCT01791205|P1|Participant Flow|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received tocilizumab (TCZ) as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98173|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98174|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98175|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98176|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98177|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98178|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98179|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98180|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98367|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)
WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
98181|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98182|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98183|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98184|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98185|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98186|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98187|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98414|NCT01790490|O2|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
98188|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98189|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98190|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98191|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98192|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98193|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98194|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98195|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98196|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98197|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98319|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98198|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98199|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98200|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98201|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
98202|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98203|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
98204|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98205|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
98206|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98207|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
98492|NCT01789775|E1|Reported Event|CD07805/47 Gel Placebo|"Placebo
Drug: CD07805/47 gel"
98493|NCT01789606|B3|Baseline|Total|Total of all reporting groups
98208|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98209|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
98210|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98211|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
98212|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98213|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98214|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
98215|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98216|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
98217|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98218|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
98320|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98219|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98220|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
98221|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98222|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98223|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98224|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98225|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98226|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98227|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98288|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98228|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98229|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98230|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98231|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98232|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98233|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98234|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98235|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98236|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98237|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98238|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98239|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98240|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98241|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98242|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98243|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98244|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98245|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98246|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98247|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98248|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
98249|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98250|NCT01791205|E1|Reported Event|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
98251|NCT01791153|B5|Baseline|Total|Total of all reporting groups
98252|NCT01791153|B4|Baseline|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98253|NCT01791153|B3|Baseline|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98254|NCT01791153|B2|Baseline|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98255|NCT01791153|B1|Baseline|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98256|NCT01791153|P4|Participant Flow|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98257|NCT01791153|P3|Participant Flow|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98258|NCT01791153|P2|Participant Flow|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection every 2 weeks (q2w) (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98259|NCT01791153|P1|Participant Flow|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 milligrams (mg) as subcutaneous (SC) injection every week (qw) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98260|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98261|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98262|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98263|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98264|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98265|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98266|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98267|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98411|NCT01790490|P2|Participant Flow|LZP, K1, and K2|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
98270|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98271|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98272|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98273|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98274|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98275|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98276|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98277|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98278|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98321|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98279|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98280|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98281|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98282|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98283|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98284|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98285|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98286|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98287|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98635|NCT01788163|O10|Outcome|Thailand-Mutation Status Negative|Subjects in Thailand that meet I/E and population criteria, who had a Negative Mutation Status.
98289|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98290|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98291|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98292|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98293|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98294|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98295|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98296|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98297|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98366|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone
Paromomycin: Paromomycin alone"
98298|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98299|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98300|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98301|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98302|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98303|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98304|NCT01791153|O3|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98305|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98306|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98307|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98701|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
98308|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98309|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98310|NCT01791153|E4|Reported Event|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
98311|NCT01791153|E3|Reported Event|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98312|NCT01791153|E2|Reported Event|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98313|NCT01791153|E1|Reported Event|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
98314|NCT01790828|B1|Baseline|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98315|NCT01790828|P1|Participant Flow|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98316|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98317|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98318|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98322|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98323|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98324|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98325|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98326|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98327|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98328|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98329|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98330|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98331|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98332|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98333|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98334|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98335|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98336|NCT01790828|E1|Reported Event|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
98337|NCT01790750|B1|Baseline|PES First, Then FFES|A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
98338|NCT01790750|P1|Participant Flow|PES First, Then FFES|A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
98339|NCT01790750|O1|Outcome|PES First, Then FFES|A 5-minute Pocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
98340|NCT01790750|O1|Outcome|PES First, Then FFES|A 5-minutePocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
98341|NCT01790750|E1|Reported Event|PES First, Then FFES|A 5-minute Pocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
98342|NCT01790685|B3|Baseline|Total|Total of all reporting groups
98343|NCT01790685|B2|Baseline|BRVO|"Branch Retinal Vein Occlusion
dexamethasone implant"
98344|NCT01790685|B1|Baseline|CRVO|"Central Retinal Vein Occlusion
dexamethasone implant"
98345|NCT01790685|P2|Participant Flow|BRVO|"Branch Retinal Vein Occlusion
dexamethasone implant"
98346|NCT01790685|P1|Participant Flow|CRVO|"Central Retinal Vein Occlusion
dexamethasone implant"
98347|NCT01790685|O2|Outcome|BRVO|"Branch Retinal Vein Occlusion
dexamethasone implant"
98348|NCT01790685|O1|Outcome|CRVO|"Central Retinal Vein Occlusion
dexamethasone implant"
98349|NCT01790685|E2|Reported Event|BRVO|"Branch Retinal Vein Occlusion
dexamethasone implant"
98350|NCT01790685|E1|Reported Event|CRVO|"Central Retinal Vein Occlusion
dexamethasone implant"
98351|NCT01790659|B3|Baseline|Total|Total of all reporting groups
98352|NCT01790659|B2|Baseline|Paromomycin|"Paromomycin alone
Paromomycin: Paromomycin alone"
98353|NCT01790659|B1|Baseline|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)
WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
98354|NCT01790659|P2|Participant Flow|Paromomycin|"Paromomycin alone
Paromomycin: Paromomycin alone"
98355|NCT01790659|P1|Participant Flow|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)
WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
98356|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone
Paromomycin: Paromomycin alone"
98357|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)
WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
98358|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone
Paromomycin: Paromomycin alone"
98359|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)
WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
98360|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone
Paromomycin: Paromomycin alone"
98361|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)
WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
98362|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone
Paromomycin: Paromomycin alone"
98363|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)
WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
98364|NCT01790659|O2|Outcome|Paromomycin|"Paromomycin alone
Paromomycin: Paromomycin alone"
98365|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)
WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
98369|NCT01790659|O1|Outcome|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)
WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
98370|NCT01790659|E2|Reported Event|Paromomycin|"Paromomycin alone
Paromomycin: Paromomycin alone"
98371|NCT01790659|E1|Reported Event|WR 279,396|"(Paromomycin and Gentamicin Topical Cream)
WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%"
98372|NCT01790633|B3|Baseline|Total|Total of all reporting groups
98373|NCT01790633|B2|Baseline|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test
Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
98374|NCT01790633|B1|Baseline|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).
ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
98375|NCT01790633|P2|Participant Flow|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test
Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
98376|NCT01790633|P1|Participant Flow|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).
ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
98377|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test
Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
98378|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).
ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
98379|NCT01790633|O1|Outcome|Screened for Eligibility|Individuals who were screened for eligibility, prior to being considered for randomization.
98702|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98380|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test
Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
98381|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).
ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
98382|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test
Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
98383|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).
ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
98384|NCT01790633|E2|Reported Event|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test
Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
98385|NCT01790633|E1|Reported Event|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).
ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
98386|NCT01790581|B3|Baseline|Total|Total of all reporting groups
98387|NCT01790581|B2|Baseline|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).
STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
98388|NCT01790581|B1|Baseline|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
98622|NCT01788163|P5|Participant Flow|Thailand|Subjects in Thailand that meet I/E and population criteria
98389|NCT01790581|P2|Participant Flow|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised sessions. Exercises and repetitions per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).
STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all treatment sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
98390|NCT01790581|P1|Participant Flow|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
98391|NCT01790581|O2|Outcome|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).
STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
98412|NCT01790490|P1|Participant Flow|K1, LZP, and K2|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
98413|NCT01790490|O3|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP) Following K1|Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
98392|NCT01790581|O1|Outcome|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
98393|NCT01790581|O2|Outcome|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).
STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
98394|NCT01790581|O1|Outcome|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
98395|NCT01790581|E2|Reported Event|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).
STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
98432|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.
Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
98433|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
98434|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.
Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
98396|NCT01790581|E1|Reported Event|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
98397|NCT01790516|B3|Baseline|Total|Total of all reporting groups
98398|NCT01790516|B2|Baseline|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab
cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
98399|NCT01790516|B1|Baseline|Cisplatin|"Intensity modulated radiation with concurrent cisplatin
platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
98400|NCT01790516|P2|Participant Flow|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab
cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
98401|NCT01790516|P1|Participant Flow|Cisplatin|"Intensity modulated radiation with concurrent cisplatin
platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
98402|NCT01790516|O2|Outcome|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab
cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
98403|NCT01790516|O1|Outcome|Cisplatin|"Intensity modulated radiation with concurrent cisplatin
platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
98404|NCT01790516|E2|Reported Event|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab
cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
98405|NCT01790516|E1|Reported Event|Cisplatin|"Intensity modulated radiation with concurrent cisplatin
platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
98406|NCT01790490|B4|Baseline|Total|Total of all reporting groups
98407|NCT01790490|B3|Baseline|K1, K2, and LZP|K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
98408|NCT01790490|B2|Baseline|LZP, K1, and K2|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
98409|NCT01790490|B1|Baseline|K1, LZP, and K2|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
98410|NCT01790490|P3|Participant Flow|K1, K2, and LZP|K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
98703|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98415|NCT01790490|O1|Outcome|Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
98416|NCT01790490|O3|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)|"Lorazepam 2 mg infused over 52 minutes (LZP)
Lorazepam 2 mg: 52 minute infusion of lorazepam 2 mg. This serves as an active control."
98417|NCT01790490|O2|Outcome|Ketamine Infusion 0.71 mg/kg Over 52 Minutes (K2)|"Ketamine 0.71 mg/kg infused over 52 min (K2)
Ketamine 0.71 mg/kg: 52 minute iv infusion of ketamine 0.71 mg/kg. This dose follows K1 in all 3 orderings."
98418|NCT01790490|O1|Outcome|Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)|"Ketamine 0.41 mg/kg infused over 52 min (K1)
Ketamine 0.41 mg/kg: 52 minute iv infusion of ketamine 0.41 mg/kg"
98419|NCT01790490|E3|Reported Event|Ketamine 0.71 (K2)|Ketamine 0.71 mg/kg over 52 minutes (K2)
98420|NCT01790490|E2|Reported Event|Lorazepam 2 mg (LZP)|Lorazepam 2 mg (LZP) over 52 minutes
98421|NCT01790490|E1|Reported Event|Ketamine 0.41 (K1)|Ketamine 0.41 (K1) over 52 minutes
98422|NCT01790178|B3|Baseline|Total|Total of all reporting groups
98423|NCT01790178|B2|Baseline|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
98424|NCT01790178|B1|Baseline|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.
Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
98425|NCT01790178|P2|Participant Flow|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
98426|NCT01790178|P1|Participant Flow|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.
Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
98427|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
98428|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.
Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
98429|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
98430|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.
Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
98431|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
98435|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
98436|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.
Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
98437|NCT01790178|E2|Reported Event|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
98438|NCT01790178|E1|Reported Event|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.
Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
98439|NCT01789970|B3|Baseline|Total|Total of all reporting groups
98440|NCT01789970|B2|Baseline|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered extended-release hydrocodone tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98441|NCT01789970|B1|Baseline|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98442|NCT01789970|P3|Participant Flow|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98443|NCT01789970|P2|Participant Flow|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98444|NCT01789970|P1|Participant Flow|Hydrocodone ER (Open-Label Titration Period)|All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
98445|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98636|NCT01788163|O9|Outcome|Thailand-Mutation Status Positive|Subjects in Thailand that meet I/E and population criteria, who had a Positive Mutation Status.
98446|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98447|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98448|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98449|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98450|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98451|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98452|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98453|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98454|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98455|NCT01789970|O3|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98474|NCT01789970|E1|Reported Event|Hydrocodone ER (Open-Label Titration Period)|All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
98475|NCT01789814|B3|Baseline|Total|Total of all reporting groups
98456|NCT01789970|O2|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98457|NCT01789970|O1|Outcome|Hydrocodone ER (Safety Analysis Set)|All enrolled participants who were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours. Includes days on hydrocodone ER during both the titration and treatment periods.
98458|NCT01789970|O4|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98459|NCT01789970|O3|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98460|NCT01789970|O2|Outcome|Opioid-Experienced (Open-Label Titration Period)|"Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening.
For opioid-experienced participants, the starting dose of hydrocodone ER tablets was to be approximately equivalent to 50% of the dose of opioid analgesic that they were receiving at screening and administered every 12 hours.
All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain."
98461|NCT01789970|O1|Outcome|Opioid-Naive (Open-Label Titration Period)|"Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening.
Opioid-naïve participants started at a 15-mg dose of hydrocodone ER tablets every 12 hours.
All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain."
98462|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98463|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98464|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98465|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98466|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98467|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98468|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98469|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98470|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98471|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98472|NCT01789970|E3|Reported Event|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
98473|NCT01789970|E2|Reported Event|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
98476|NCT01789814|B2|Baseline|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention
Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
98477|NCT01789814|B1|Baseline|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention
Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
98478|NCT01789814|P2|Participant Flow|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention
Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
98479|NCT01789814|P1|Participant Flow|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention
Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
98480|NCT01789814|O2|Outcome|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention
Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
98481|NCT01789814|O1|Outcome|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention
Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
98482|NCT01789814|E2|Reported Event|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention
Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
98483|NCT01789814|E1|Reported Event|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention
Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
98484|NCT01789775|B3|Baseline|Total|Total of all reporting groups
98485|NCT01789775|B2|Baseline|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel
CD07805/47 gel Placebo"
98486|NCT01789775|B1|Baseline|CD07805/47 Gel Placebo|"Placebo
Drug: CD07805/47 gel"
98487|NCT01789775|P2|Participant Flow|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel
CD07805/47 gel Placebo"
98488|NCT01789775|P1|Participant Flow|CD07805/47 Gel Placebo|"Placebo
Drug: CD07805/47 gel"
98489|NCT01789775|O2|Outcome|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel
CD07805/47 gel Placebo"
98490|NCT01789775|O1|Outcome|CD07805/47 Gel Placebo|"Placebo
Drug: CD07805/47 gel"
98491|NCT01789775|E2|Reported Event|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel
CD07805/47 gel Placebo"
98494|NCT01789606|B2|Baseline|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98495|NCT01789606|B1|Baseline|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
98496|NCT01789606|P2|Participant Flow|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98497|NCT01789606|P1|Participant Flow|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
98498|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98499|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98500|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98501|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98502|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98503|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98504|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98505|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98506|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98507|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98508|NCT01789606|O1|Outcome|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98509|NCT01789606|O1|Outcome|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
98510|NCT01789606|O1|Outcome|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
98511|NCT01789606|O1|Outcome|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
98512|NCT01789606|O1|Outcome|Self-Selection Arm|Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
98513|NCT01789606|E1|Reported Event|Compliance Arm|Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
98514|NCT01789476|B3|Baseline|Total|Total of all reporting groups
98515|NCT01789476|B2|Baseline|Placebo|Matched placebo
98516|NCT01789476|B1|Baseline|CR845|CR845 (0.005 mg/kg) IV
98517|NCT01789476|P2|Participant Flow|Placebo|Matched placebo
98518|NCT01789476|P1|Participant Flow|CR845|CR845 (0.005 mg/kg) IV
98519|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
98520|NCT01789476|O1|Outcome|Placebo|Matched placebo
98521|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
98522|NCT01789476|O1|Outcome|Placebo|Matched placebo
98523|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
98524|NCT01789476|O1|Outcome|Placebo|Matched placebo
98525|NCT01789476|E2|Reported Event|Placebo|Matched placebo
98526|NCT01789476|E1|Reported Event|CR845|CR845 (0.005 mg/kg) IV
98637|NCT01788163|O8|Outcome|Australia-Mutation Status Negative|Subjects in Australia that meet I/E and population criteria, who had a Negative Mutation Status.
98527|NCT01789255|B1|Baseline|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
98528|NCT01789255|P1|Participant Flow|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
98529|NCT01789255|O1|Outcome|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
98530|NCT01789255|O1|Outcome|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
98531|NCT01789255|E1|Reported Event|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
98532|NCT01789138|B3|Baseline|Total|Total of all reporting groups
98533|NCT01789138|B2|Baseline|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
98534|NCT01789138|B1|Baseline|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.
Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
98535|NCT01789138|P2|Participant Flow|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
98549|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
98584|NCT01788228|E1|Reported Event|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98536|NCT01789138|P1|Participant Flow|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.
Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
98537|NCT01789138|O2|Outcome|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
98538|NCT01789138|O1|Outcome|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.
Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
98539|NCT01789138|O2|Outcome|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
98540|NCT01789138|O1|Outcome|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.
Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
98541|NCT01789138|E2|Reported Event|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
98573|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98542|NCT01789138|E1|Reported Event|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.
Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
98543|NCT01788566|B1|Baseline|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
98544|NCT01788566|P1|Participant Flow|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
98545|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
98546|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
98547|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
98548|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
98585|NCT01788215|B3|Baseline|Total|Total of all reporting groups
98678|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98550|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
98551|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
98552|NCT01788566|E1|Reported Event|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
98553|NCT01788358|B1|Baseline|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98554|NCT01788358|P1|Participant Flow|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98555|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98556|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98696|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98557|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98558|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98559|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98560|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98561|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98562|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98610|NCT01788163|B8|Baseline|Indonesia|Subjects in Indonesia that meet I/E and population criteria
98563|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98564|NCT01788358|E1|Reported Event|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
98565|NCT01788228|B3|Baseline|Total|Total of all reporting groups
98566|NCT01788228|B2|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98567|NCT01788228|B1|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98568|NCT01788228|P2|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98569|NCT01788228|P1|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98570|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98571|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98572|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98697|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
98574|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98575|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98576|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98577|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98578|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98579|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98580|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98581|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98582|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98583|NCT01788228|E2|Reported Event|Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group|Subjects ˃64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
98611|NCT01788163|B7|Baseline|Malaysia|Subjects in Malaysia that meet I/E and population criteria
98586|NCT01788215|B2|Baseline|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day"
98587|NCT01788215|B1|Baseline|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily"
98588|NCT01788215|P2|Participant Flow|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day"
98589|NCT01788215|P1|Participant Flow|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily"
98590|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day"
98591|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily"
98592|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day"
98593|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily"
98594|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day"
98595|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily"
98596|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day"
98698|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
98597|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily"
98598|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day"
98599|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily"
98600|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day"
98601|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily"
98602|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day"
98603|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily"
98604|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day"
98605|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily"
98606|NCT01788215|E2|Reported Event|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day"
98607|NCT01788215|E1|Reported Event|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily"
98608|NCT01788163|B10|Baseline|Total|Total of all reporting groups
98609|NCT01788163|B9|Baseline|Russia|Subjects in Russia that meet I/E and population criteria
98623|NCT01788163|P4|Participant Flow|Australia|Subjects in Australia that meet I/E and population criteria
98624|NCT01788163|P3|Participant Flow|South Korea|Subjects in South Korea that meet I/E and population criteria
98625|NCT01788163|P2|Participant Flow|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98626|NCT01788163|P1|Participant Flow|China|Subjects in China that meet Inclusion/Exclusion (I/E) and population criteria.
98627|NCT01788163|O18|Outcome|Russia-Mutation Status Negative|Subjects in Russia that meet I/E and population criteria, who had a Negative Mutation Status.
98628|NCT01788163|O17|Outcome|Russia-Mutation Status Positive|Subjects in Russia that meet I/E and population criteria, who had a Positive Mutation Status.
98629|NCT01788163|O16|Outcome|Indonesia-Mutation Status Negative|Subjects in Indonesia that meet I/E and population criteria, who had a Negative Mutation Status.
98630|NCT01788163|O15|Outcome|Indonesia-Mutation Status Positive|Subjects in Indonesia that meet I/E and population criteria, who had a Positive Mutation Status.
98631|NCT01788163|O14|Outcome|Malaysia-Mutation Status Negative|Subjects in Malaysia that meet I/E and population criteria, who had a Negative Mutation Status.
98632|NCT01788163|O13|Outcome|Malaysia-Mutation Status Positive|Subjects in Malaysia that meet I/E and population criteria, who had a Positive Mutation Status.
98633|NCT01788163|O12|Outcome|Singapore-Mutation Status Negative|Subjects in Singapore that meet I/E and population criteria, who had a Negative Mutation Status.
98634|NCT01788163|O11|Outcome|Singapore-Mutation Status Positive|Subjects in Singapore that meet I/E and population criteria, who had a Positive Mutation Status.
98699|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
98638|NCT01788163|O7|Outcome|Australia-Mutation Status Positive|Subjects in Australia that meet I/E and population criteria, who had a Positive Mutation Status.
98639|NCT01788163|O6|Outcome|South Korea-Mutation Status Negative|Subjects in South Korea that meet I/E and population criteria, who had a Negative Mutation Status.
98640|NCT01788163|O5|Outcome|South Korea-Mutation Status Positive|Subjects in South Korea that meet I/E and population criteria, who had a Positive Mutation Status.
98641|NCT01788163|O4|Outcome|Taiwan-Mutation Status Negative|Subjects in Taiwan that meet I/E and population criteria, who had a Negative Mutation Status.
98642|NCT01788163|O3|Outcome|Taiwan-Mutation Status Positive|Subjects in Taiwan that meet I/E and population criteria, who had a Positive Mutation Status.
98643|NCT01788163|O2|Outcome|China-Mutation Status Negative|Subjects in China that meet I/E and population criteria, who had a Negative Mutation Status.
98644|NCT01788163|O1|Outcome|China-Mutation Status Positive|Subjects in China that meet I/E and population criteria, who had a Positive Mutation Status.
98645|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98646|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
98647|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
98648|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
98649|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
98650|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
98651|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98652|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98653|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
98654|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
98655|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
98656|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
98657|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
98658|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
98659|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
98660|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
98661|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
98662|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
98663|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
98664|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
98665|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
98666|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98667|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98668|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98669|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria
98670|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98671|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98672|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98673|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
98674|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98675|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98676|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98677|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
98680|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
98681|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
98682|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
98683|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
98684|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98685|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98686|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
98687|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98688|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
98689|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
98690|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
98691|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
98692|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
98693|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98694|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98695|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
98704|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
98705|NCT01788163|O8|Outcome|Russia - Negative Predictive Value|Subjects in Russia that meet I/E and population criteria, who had a Negative Predictive test performed.
98706|NCT01788163|O7|Outcome|Russia - Positive Predictive Value|Subjects in Russia that meet I/E and population criteria, who had a Positive Predictive test performed.
98707|NCT01788163|O6|Outcome|South Korea - Negative Predictive Value|Subjects in South Korea that meet I/E and population criteria, who had a Negative Predictive test performed.
98708|NCT01788163|O5|Outcome|South Korea - Positive Predictive Value|Subjects in South Korea that meet I/E and population criteria, who had a Positive Predictive test performed.
98709|NCT01788163|O4|Outcome|Taiwan - Negative Predictive Value|Subjects in Taiwan that meet I/E and population criteria, who had a Negative Predictive test performed.
98710|NCT01788163|O3|Outcome|Taiwan - Positive Predictive Value|Subjects in Taiwan that meet I/E and population criteria, who had a Positive Predictive test performed.
98711|NCT01788163|O2|Outcome|China - Negative Predictive Value|Subjects in China that meet I/E and population criteria, who had a Negative Predictive test performed.
98712|NCT01788163|O1|Outcome|China - Positive Predictive Value|Subjects in China that meet I/E and population criteria, who had a Positive Predictive test performed.
98713|NCT01788163|O8|Outcome|Russia - Specificity|Subjects in Russia that meet I/E and population criteria, who had a specificity test performed.
98714|NCT01788163|O7|Outcome|Russia - Sensitivity|Subjects in Russia that meet I/E and population criteria, who had a sensitivity test performed.
98715|NCT01788163|O6|Outcome|South Korea - Specificity|Subjects in South Korea that meet I/E and population criteria, who had a specificity test performed.
98716|NCT01788163|O5|Outcome|South Korea - Sensitivity|Subjects in South Korea that meet I/E and population criteria, who had a sensitivity test performed.
98717|NCT01788163|O4|Outcome|Taiwan - Specificity|Subjects in Taiwan that meet I/E and population criteria, who had a specificity test performed.
98718|NCT01788163|O3|Outcome|Taiwan - Sensitivity|Subjects in Taiwan that meet I/E and population criteria, who had a sensitivity test performed.
98719|NCT01788163|O2|Outcome|China - Specificty|Subjects in China that meet I/E and population criteria, who had a specificity test performed.
98720|NCT01788163|O1|Outcome|China - Sensitivity|Subjects in China that meet I/E and population criteria, who had a sensitivity test performed.
98721|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98722|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98723|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98724|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
98725|NCT01788163|O8|Outcome|Russia-Non-adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98726|NCT01788163|O7|Outcome|Russia-Adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
98727|NCT01788163|O6|Outcome|South Korea-Non-adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98728|NCT01788163|O5|Outcome|South Korea-Adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Adenocarcinoma.
98729|NCT01788163|O4|Outcome|Taiwan-Non-adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98730|NCT01788163|O3|Outcome|Taiwan-Adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Adenocarcinoma.
98731|NCT01788163|O2|Outcome|China-Non-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98732|NCT01788163|O1|Outcome|China-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Adenocarcinoma.
98733|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98734|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98735|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98736|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
98737|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98738|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98739|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98740|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
98741|NCT01788163|O18|Outcome|Russia-Non-adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98742|NCT01788163|O17|Outcome|Russia-Adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
98743|NCT01788163|O16|Outcome|Indonesia-Non-adenocarcinoma|Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98744|NCT01788163|O15|Outcome|Indonesia-Adenocarcinoma|Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
98745|NCT01788163|O14|Outcome|Malaysia-Non-adenocarcinoma|Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98746|NCT01788163|O13|Outcome|Malaysia-Adenocarcinoma|Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
98747|NCT01788163|O12|Outcome|Singapore-Non-adenocarcinoma|Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98748|NCT01788163|O11|Outcome|Singapore-Adenocarcinoma|Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
98749|NCT01788163|O10|Outcome|Thailand-Non-adenocarcinoma|Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98750|NCT01788163|O9|Outcome|Thailand-Adenocarcinoma|Subjects in Thailand that meet I/E and population criteria with a histological type of Adenocarcinoma.
98827|NCT01787760|B2|Baseline|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality
98751|NCT01788163|O8|Outcome|Australia-Non-adenocarcinoma|Subjects in Australia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98752|NCT01788163|O7|Outcome|Australia-Adenocarcinoma|Subjects in Australia that meet I/E and population criteria with a histological type of Adenocarcinoma.
98753|NCT01788163|O6|Outcome|South Korea-Non-adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98754|NCT01788163|O5|Outcome|South Korea-Adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Adenocarcinoma.
98755|NCT01788163|O4|Outcome|Taiwan-Non-adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98756|NCT01788163|O3|Outcome|Taiwan-Adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Adenocarcinoma.
98757|NCT01788163|O2|Outcome|China-Non-adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
98758|NCT01788163|O1|Outcome|China-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Adenocarcinoma.
98759|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98760|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
98761|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
98762|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
98763|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
98764|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
98765|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98766|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98767|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
98768|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
98769|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
98770|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
98771|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
98772|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
98773|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
98774|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
98775|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98776|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
98777|NCT01788163|E9|Reported Event|Russia|Subjects in Russia that meet I/E and population criteria
98778|NCT01788163|E8|Reported Event|Indonesia|Subjects in Indonesia that meet I/E and population criteria
98779|NCT01788163|E7|Reported Event|Malaysia|Subjects in Malaysia that meet I/E and population criteria
98780|NCT01788163|E6|Reported Event|Singapore|Subjects in Singapore that meet I/E and population criteria
98781|NCT01788163|E5|Reported Event|Thailand|Subjects in Thailand that meet I/E and population criteria
98782|NCT01788163|E4|Reported Event|Australia|Subjects in Australia that meet I/E and population criteria
98783|NCT01788163|E3|Reported Event|South Korea|Subjects in South Korea that meet I/E and population criteria
98784|NCT01788163|E2|Reported Event|Taiwan|Subjects in Taiwan that meet I/E and population criteria
98785|NCT01788163|E1|Reported Event|China|Subjects in China that meet I/E and population criteria.
98786|NCT01788046|B3|Baseline|Total|Total of all reporting groups
98787|NCT01788046|B2|Baseline|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
98788|NCT01788046|B1|Baseline|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
98789|NCT01788046|P2|Participant Flow|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
98790|NCT01788046|P1|Participant Flow|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
98893|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98791|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
98792|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
98793|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
98794|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
98795|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
98796|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
98797|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
98798|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
98799|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
98828|NCT01787760|B1|Baseline|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality
98800|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
98801|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
98802|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
98803|NCT01788046|E2|Reported Event|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
98804|NCT01788046|E1|Reported Event|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
98805|NCT01787838|B1|Baseline|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.
Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.
The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
98806|NCT01787838|P1|Participant Flow|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.
Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.
The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
98807|NCT01787838|O1|Outcome|Health Education, Audit and Feedback|"Prospective single group intervention Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.
The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about immunizations."
98808|NCT01787838|E1|Reported Event|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.
Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.
The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
98809|NCT01787825|B1|Baseline|All Study Participants|"PillCam SB2 capsule and CapsoCam SV-1 capsule in random order, PillCam SB2 capsule: Capsule Endoscopy system, CapsoCam SV-1: Capsule endoscopy
The analysis population consisted of subjects that swallowed the capsules."
98810|NCT01787825|P2|Participant Flow|PillCam SB2 Then CapsoCam SV-1|Participants first received PillCam SB2 then 30-60 minutes later receive CapsoCam SV-1
98811|NCT01787825|P1|Participant Flow|CapsoCam SV-1 Then PillCam SB2|Participants first received CapsoCam SV-1 then 30-60 minutes later received Pillcam SB2
98812|NCT01787825|O2|Outcome|PillCam SB2|Subject preference for PillCam SB2
98813|NCT01787825|O1|Outcome|CapsoCam SV-1 Preference|Subject preference for CapsoCam SV-1
98814|NCT01787825|O2|Outcome|PillCam SB2|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
98815|NCT01787825|O1|Outcome|CapsoCam SV-1|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
98816|NCT01787825|O2|Outcome|PillCam SB2|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
98817|NCT01787825|O1|Outcome|CapsoCam SV-1|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
98818|NCT01787825|O2|Outcome|PillCam SB2|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
99329|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
98819|NCT01787825|O1|Outcome|CapsoCam SV-1|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
98820|NCT01787825|E1|Reported Event|All Study Participants|PillCam SB Capsule and CapsoCam SV-1
98821|NCT01787799|B1|Baseline|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
98822|NCT01787799|P1|Participant Flow|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
98823|NCT01787799|O1|Outcome|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
98824|NCT01787799|E1|Reported Event|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
98825|NCT01787760|B4|Baseline|Total|Total of all reporting groups
98826|NCT01787760|B3|Baseline|Spectacle Lenses|Control spectacle lenses worn daily.
98829|NCT01787760|P3|Participant Flow|Spectacle Lenses|Control spectacle lenses worn daily.
98830|NCT01787760|P2|Participant Flow|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality
98831|NCT01787760|P1|Participant Flow|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality
98832|NCT01787760|O3|Outcome|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
98833|NCT01787760|O2|Outcome|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
98834|NCT01787760|O1|Outcome|Spectacle Lenses|Control spectacle lenses worn daily.
98835|NCT01787760|O3|Outcome|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
98836|NCT01787760|O2|Outcome|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
98837|NCT01787760|O1|Outcome|Spectacle Lenses|Control spectacle lenses worn daily.
98838|NCT01787760|E4|Reported Event|Not Randomized|Subjects who met the all study eligible criteria but did not randomize to the study arm.
98839|NCT01787760|E3|Reported Event|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
98840|NCT01787760|E2|Reported Event|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
98841|NCT01787760|E1|Reported Event|Spectacle Lenses|Control spectacle lenses worn daily.
98842|NCT01787591|B3|Baseline|Total|Total of all reporting groups
98843|NCT01787591|B2|Baseline|Metabolic Syndrome Participants|As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
98844|NCT01787591|B1|Baseline|Healthy Participants|As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
98845|NCT01787591|P4|Participant Flow|Acute Soy Milk Ingestion First|"Participants ingested soy milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and fat-free milk.
Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.
Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98846|NCT01787591|P3|Participant Flow|Acute Full-Fat Milk Ingestion First|"Participants ingested full-free milk first and then the remaining three milks in a randomized order: low-fat milk, low-fat milk, and soy milk.
Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98847|NCT01787591|P2|Participant Flow|Acute Low-Fat Milk Ingestion First|"Participants ingested low-free milk first and then the remaining three milks in a randomized order: fat-fat milk, full-fat milk, and soy milk.
Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98848|NCT01787591|P1|Participant Flow|Acute Fat-Free Milk Ingestion First|"Participants ingested fat-free milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and soy milk.
Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98849|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
98850|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98851|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98852|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98853|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
98854|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98855|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98856|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98857|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
98858|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98859|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98860|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98861|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
98862|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98863|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98864|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98865|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants received 1 cup of soy milk with deuterium labeled alpha-tocopherol
98866|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98867|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98868|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98869|NCT01787591|E4|Reported Event|Acute Soy Milk Ingestion|"Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.
Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98870|NCT01787591|E3|Reported Event|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98871|NCT01787591|E2|Reported Event|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98872|NCT01787591|E1|Reported Event|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
98873|NCT01787461|B3|Baseline|Total|Total of all reporting groups
98874|NCT01787461|B2|Baseline|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98875|NCT01787461|B1|Baseline|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98876|NCT01787461|P2|Participant Flow|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98877|NCT01787461|P1|Participant Flow|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98878|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98879|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98880|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98881|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98882|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98883|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98884|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98885|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98886|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98887|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98888|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98889|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98890|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98891|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98892|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98894|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98895|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98896|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98897|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98898|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98899|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98900|NCT01787461|E2|Reported Event|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
98901|NCT01787461|E1|Reported Event|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
98902|NCT01787383|B3|Baseline|Total|Total of all reporting groups
98903|NCT01787383|B2|Baseline|Ingenol Mebutate Gel Sequential Treatment|"Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied sequentially
Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied sequentially"
98962|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98904|NCT01787383|B1|Baseline|Ingenol Mebutate Gel Simultaneous Treatment|"Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied simultaneously
Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied simultaneously"
98905|NCT01787383|P2|Participant Flow|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98906|NCT01787383|P1|Participant Flow|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98907|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Convenience TSQM compliance was lower than the number of randomised subjects.
98908|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Convenience TSQM compliance was lower than the number of randomised subjects.
98909|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Global Satisfaction TSQM compliance was lower than the number of randomised subjects.
98910|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Global Satisfaction TSQM compliance was lower than the number of randomised subjects.
98911|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Side Effects TSQM compliance was lower than the number of randomised subjects.
98912|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Side EffectsTSQM compliance was lower than the number of randomised subjects.
98913|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Effectiveness TSQM compliance was lower than the number of randomised subjects.
98914|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Effectiveness TSQM compliance was lower than the number of randomised subjects.
98915|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98916|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98943|NCT01787240|O2|Outcome|Phase 2 Active|Participants assigned to take active drug who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
98917|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98918|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98919|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98920|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98921|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98922|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98923|NCT01787383|E2|Reported Event|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98924|NCT01787383|E1|Reported Event|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
98925|NCT01787279|B1|Baseline|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
98926|NCT01787279|P1|Participant Flow|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered peg interferon alpha-2a (PEGASYS), 40 kilodalton (kD), 180 micrograms (mcg), subcutaneously, once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
98927|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
98928|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
98929|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
98930|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
98931|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
98932|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
98933|NCT01787279|E1|Reported Event|Peginterferon Alpha-2a, 180 mcg/ 48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
98934|NCT01787240|B3|Baseline|Total|Total of all reporting groups
98935|NCT01787240|B2|Baseline|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
Escitalopram 10mg"
98936|NCT01787240|B1|Baseline|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
Placebo"
98937|NCT01787240|P2|Participant Flow|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
Escitalopram 10mg"
98938|NCT01787240|P1|Participant Flow|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
Placebo"
98939|NCT01787240|O2|Outcome|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
Escitalopram 10mg"
98940|NCT01787240|O1|Outcome|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
Placebo"
98941|NCT01787240|O2|Outcome|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
Escitalopram 10mg"
98942|NCT01787240|O1|Outcome|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
Placebo"
99332|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
98944|NCT01787240|O1|Outcome|Phase 2 Placebo|Participants assigned to take placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
98945|NCT01787240|O1|Outcome|Eligible Patients|Number of patients who were screened and were determined to be eligible for the study.
98946|NCT01787240|E2|Reported Event|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
Escitalopram 10mg"
98947|NCT01787240|E1|Reported Event|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.
Placebo"
98948|NCT01787188|B4|Baseline|Total|Total of all reporting groups
98949|NCT01787188|B3|Baseline|Placebo|Placebo: Capsule
98950|NCT01787188|B2|Baseline|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98951|NCT01787188|B1|Baseline|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98952|NCT01787188|P3|Participant Flow|Placebo|Placebo: Capsule
98953|NCT01787188|P2|Participant Flow|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98954|NCT01787188|P1|Participant Flow|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98955|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98956|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98957|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98958|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98959|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98960|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98961|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98963|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98964|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98965|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98966|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98967|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98968|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98969|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98970|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98971|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98972|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98973|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98974|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98975|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98976|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98977|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98978|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98979|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98980|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98981|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98982|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98983|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98984|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98985|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98986|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98987|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98988|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98989|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98990|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98991|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98992|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98993|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98994|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98995|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98996|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
98997|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
98998|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
98999|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
99000|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
99001|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
99002|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
99003|NCT01787188|E3|Reported Event|Placebo|Placebo: Capsule
99004|NCT01787188|E2|Reported Event|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
99005|NCT01787188|E1|Reported Event|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
99006|NCT01787175|B3|Baseline|Total|Total of all reporting groups
99007|NCT01787175|B2|Baseline|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
99008|NCT01787175|B1|Baseline|Integration Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
99009|NCT01787175|P2|Participant Flow|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
99141|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99010|NCT01787175|P1|Participant Flow|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
99011|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
99012|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
99013|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
99014|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
99015|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
99081|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
DA-3002"
99016|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
99017|NCT01787175|E2|Reported Event|Standard EHR|"Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
Integrated Medication Manager: A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use."
99018|NCT01787175|E1|Reported Event|Integrated Medication Manager|"Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
Integrated Medication Manager: A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use."
99019|NCT01787032|B7|Baseline|Total|Total of all reporting groups
99020|NCT01787032|B6|Baseline|BI 113608 + Voriconazole/ BI 113608 + Ketoconazole/ BI 113608|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99021|NCT01787032|B5|Baseline|BI 113608 + Voriconazole/ BI 113608/ BI 113608 + Ketoconazole|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99022|NCT01787032|B4|Baseline|BI 113608 + Ketoconazole/ BI 113608 + Voriconazole/ BI 113608|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99023|NCT01787032|B3|Baseline|BI 113608 + Ketoconazole/ BI 113608/ BI 113608 + Voriconazole|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99063|NCT01786954|P2|Participant Flow|Sequence 2: Icare Then Tonopen Then Goldmann|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Tonopen applanation then Goldmann applanation.
Icare rebound tonometry
Tonopen applanation
Goldmann applanation"
99024|NCT01787032|B2|Baseline|BI 113608/BI 113608 + Voriconazole/ BI 113608 + Ketoconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99025|NCT01787032|B1|Baseline|BI 113608/BI 113608 + Ketoconazole/BI 113608 + Voriconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99026|NCT01787032|P6|Participant Flow|BI 113608 + Voriconazole/ BI 113608 + Ketoconazole/ BI 113608|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99044|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99027|NCT01787032|P5|Participant Flow|BI 113608 + Voriconazole/ BI 113608/ BI 113608 + Ketoconazole|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99028|NCT01787032|P4|Participant Flow|BI 113608 + Ketoconazole/ BI 113608 + Voriconazole/ BI 113608|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99029|NCT01787032|P3|Participant Flow|BI 113608 + Ketoconazole/ BI 113608/ BI 113608 + Voriconazole|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99030|NCT01787032|P2|Participant Flow|BI 113608/BI 113608 + Voriconazole/ BI 113608 + Ketoconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99031|NCT01787032|P1|Participant Flow|BI 113608/BI 113608 + Ketoconazole/BI 113608 + Voriconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
A wash-out period of at least 6 days was respected between the administrations of BI 113608."
99032|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99033|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99034|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
99035|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99036|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99037|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
99038|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99039|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99040|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
99041|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99042|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99043|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
99045|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99046|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
99047|NCT01787032|E5|Reported Event|Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) orally with 240 mL of water after an overnight fast of at least 10 hours.
99048|NCT01787032|E4|Reported Event|Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) orally with 240 mL of water after an overnight fast of at least 10 hours.
99049|NCT01787032|E3|Reported Event|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99050|NCT01787032|E2|Reported Event|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
99051|NCT01787032|E1|Reported Event|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
99052|NCT01786993|B3|Baseline|Total|Total of all reporting groups
99053|NCT01786993|B2|Baseline|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
99054|NCT01786993|B1|Baseline|MultiPoint Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
99055|NCT01786993|P2|Participant Flow|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
99056|NCT01786993|P1|Participant Flow|Multi-point Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
99057|NCT01786993|O2|Outcome|Biventricular Arm|"Traditional Biventricular Pacing
Traditional Biventricular Pacing: Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available."
99058|NCT01786993|O1|Outcome|MultiPoint Pacing Arm|"MultiPoint Pacing
MultiPoint Pacing: Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study."
99059|NCT01786993|O1|Outcome|BiV/MPP Patients|Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication).
99060|NCT01786993|E2|Reported Event|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
99061|NCT01786993|E1|Reported Event|MultiPoint Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
99062|NCT01786954|B1|Baseline|Icare, Goldmann, Tonopen|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
Icare rebound tonometry
Tonopen applanation
Goldmann applanation"
99110|NCT01786707|O2|Outcome|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
99064|NCT01786954|P1|Participant Flow|Sequence 1: Icare Then Goldmann Then Tonopen|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Goldmann applanation then Tonopen applanation.
Icare rebound tonometry
Goldmann applanation
Tonopen applanation"
99065|NCT01786954|O3|Outcome|Goldmann|
99066|NCT01786954|O2|Outcome|Tonopen|
99067|NCT01786954|O1|Outcome|Icare|
99068|NCT01786954|O3|Outcome|Goldmann|Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
99069|NCT01786954|O2|Outcome|Tonopen|Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
99070|NCT01786954|O1|Outcome|Icare|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
Icare rebound tonometry"
99071|NCT01786954|E2|Reported Event|Sequence 2: Icare, Tonopen, Goldmann|Sequence 2: Icare, then Tonopen, then Goldmann
99072|NCT01786954|E1|Reported Event|Sequence 1: Icare, Goldmann, Tonopen|Sequence 1: Icare, then Goldmann, then Tonopen
99073|NCT01786902|B3|Baseline|Total|Total of all reporting groups
99074|NCT01786902|B2|Baseline|Non-treatment Control Group|Height be measured with no treatment
99075|NCT01786902|B1|Baseline|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
DA-3002"
99076|NCT01786902|P2|Participant Flow|Non-treatment Control Group|Height be measured with no treatment
99077|NCT01786902|P1|Participant Flow|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
DA-3002"
99078|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
99079|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
DA-3002"
99080|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
99082|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
99083|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
DA-3002"
99084|NCT01786902|E2|Reported Event|Non-treatment Control Group|Height be measured with no treatment
99085|NCT01786902|E1|Reported Event|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
DA-3002"
99086|NCT01786876|B1|Baseline|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99087|NCT01786876|P1|Participant Flow|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99088|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99089|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99090|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99091|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99092|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99093|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99094|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99095|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99096|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99097|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99098|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99099|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99100|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99101|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99102|NCT01786876|E1|Reported Event|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
99103|NCT01786707|B3|Baseline|Total|Total of all reporting groups
99104|NCT01786707|B2|Baseline|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
99105|NCT01786707|B1|Baseline|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy
Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
99106|NCT01786707|P2|Participant Flow|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
99107|NCT01786707|P1|Participant Flow|Autologous Stem Cell and HOT|"Autologous stem cells (SC) and hyperbaric oxygen therapy
Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
99108|NCT01786707|O2|Outcome|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
99109|NCT01786707|O1|Outcome|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy
Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
99111|NCT01786707|O1|Outcome|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy
Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
99112|NCT01786707|E2|Reported Event|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
99113|NCT01786707|E1|Reported Event|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy
Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
99114|NCT01786668|B5|Baseline|Total|Total of all reporting groups
99115|NCT01786668|B4|Baseline|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99116|NCT01786668|B3|Baseline|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99117|NCT01786668|B2|Baseline|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99118|NCT01786668|B1|Baseline|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99119|NCT01786668|P4|Participant Flow|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99291|NCT01786161|B2|Baseline|Intermittent Infusion|"infusion rate 1000mg/hr
Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
99120|NCT01786668|P3|Participant Flow|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99121|NCT01786668|P2|Participant Flow|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99122|NCT01786668|P1|Participant Flow|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the morning [AM] and afternoon [PM]) for a total of 12 weeks.
99123|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99124|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99125|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99126|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99127|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99128|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99129|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99130|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99131|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99132|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99133|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99134|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99135|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99136|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99137|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99138|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99139|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99140|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99142|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99143|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99144|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99145|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99146|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99147|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99148|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99149|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99150|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99813|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99151|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99152|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99153|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99154|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99155|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99156|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99157|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99158|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99159|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99160|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99161|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99162|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99163|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99164|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99165|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99166|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99167|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99168|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99169|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99170|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99171|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99172|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99173|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99174|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99175|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99176|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99177|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99178|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99179|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99180|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99181|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99292|NCT01786161|B1|Baseline|Vancomycin Continous Infusion|Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion infusion rate 1000mg/hr
99182|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99183|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99184|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99185|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99186|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99187|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99188|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99189|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99190|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99191|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99192|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99193|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99194|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99195|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99196|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99197|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99198|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99199|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99200|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99201|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99202|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99203|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99204|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99205|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99206|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99207|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99208|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99209|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99210|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99211|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99212|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99293|NCT01786161|P2|Participant Flow|Vancomycin With Intermittent Dose Interval|"infusion rate 1000mg/hr
Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
99213|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99214|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99215|NCT01786668|E4|Reported Event|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99216|NCT01786668|E3|Reported Event|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
99217|NCT01786668|E2|Reported Event|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99218|NCT01786668|E1|Reported Event|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
99219|NCT01786629|B3|Baseline|Total|Total of all reporting groups
99220|NCT01786629|B2|Baseline|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes
FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
99221|NCT01786629|B1|Baseline|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit
SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
99222|NCT01786629|P2|Participant Flow|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes
FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
99223|NCT01786629|P1|Participant Flow|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit
SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
99224|NCT01786629|O2|Outcome|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes
FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
99225|NCT01786629|O1|Outcome|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit
SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
99226|NCT01786629|E2|Reported Event|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes
FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
99227|NCT01786629|E1|Reported Event|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit
SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
99228|NCT01786551|B1|Baseline|Eplerenone|Eplerenone 50 mg daily for 14 days
99229|NCT01786551|P1|Participant Flow|Eplerenone|Eplerenone 50 mg daily for 14 days
99230|NCT01786551|O1|Outcome|Eplerenone|Eplerenone 50 mg daily for 14 days
99231|NCT01786551|O1|Outcome|Eplerenone|Eplerenone 50 mg daily for 14 days
99232|NCT01786551|O1|Outcome|Eplerenone|Eplerenone 50 mg daily for 14 days
99233|NCT01786551|E1|Reported Event|Eplerenone|Eplerenone 50 mg daily for 14 days
99234|NCT01786330|B3|Baseline|Total|Total of all reporting groups
99235|NCT01786330|B2|Baseline|Control|"Group receives standard of care
Standard of Care"
99236|NCT01786330|B1|Baseline|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.
Procare abdominal binder"
99237|NCT01786330|P2|Participant Flow|Control|"Group receives standard of care
Standard of Care"
99238|NCT01786330|P1|Participant Flow|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.
Procare abdominal binder"
99239|NCT01786330|O2|Outcome|Control|"Group receives standard of care
Standard of Care"
99240|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.
Procare abdominal binder"
99241|NCT01786330|O2|Outcome|Control|"Group receives standard of care
Standard of Care"
99330|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
99242|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.
Procare abdominal binder"
99243|NCT01786330|O2|Outcome|Control|"Group receives standard of care
Standard of Care"
99244|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.
Procare abdominal binder"
99245|NCT01786330|O2|Outcome|Control|"Group receives standard of care
Standard of Care"
99246|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.
Procare abdominal binder"
99247|NCT01786330|E2|Reported Event|Control|"Group receives standard of care
Standard of Care"
99248|NCT01786330|E1|Reported Event|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.
Procare abdominal binder"
99249|NCT01786252|B3|Baseline|Total|Total of all reporting groups
99250|NCT01786252|B2|Baseline|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.
Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
99288|NCT01786174|E2|Reported Event|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days
Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
99289|NCT01786174|E1|Reported Event|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days
Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
99290|NCT01786161|B3|Baseline|Total|Total of all reporting groups
99251|NCT01786252|B1|Baseline|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.
human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
99252|NCT01786252|P2|Participant Flow|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.
Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
99253|NCT01786252|P1|Participant Flow|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.
human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
99254|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.
Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
99255|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.
human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
99256|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.
Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
99257|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.
human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
99258|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.
Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
99274|NCT01786174|B2|Baseline|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days
Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
99331|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
99259|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.
human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
99260|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.
Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
99261|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.
human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
99262|NCT01786252|E2|Reported Event|Drug: Human Chorionic Gonadotropin (hCG)|Received hCG infusion on Day 3 Post-Ovulation Induction
99263|NCT01786252|E1|Reported Event|"IVF Media (Global-Trademark)"|Received IVF media infusion on Day 3 Post-Ovulation Induction
99264|NCT01786239|B3|Baseline|Total|Total of all reporting groups
99265|NCT01786239|B2|Baseline|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
99266|NCT01786239|B1|Baseline|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
99267|NCT01786239|P2|Participant Flow|Amber50/50 Soybean Corn Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Amber 50/50 Soybean/Corn Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
99268|NCT01786239|P1|Participant Flow|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
99269|NCT01786239|O2|Outcome|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
99270|NCT01786239|O1|Outcome|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
99271|NCT01786239|E2|Reported Event|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
99272|NCT01786239|E1|Reported Event|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
99273|NCT01786174|B3|Baseline|Total|Total of all reporting groups
99328|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
99275|NCT01786174|B1|Baseline|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days
Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
99276|NCT01786174|P2|Participant Flow|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days
Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
99277|NCT01786174|P1|Participant Flow|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days
Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
99278|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days
Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
99279|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days
Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
99280|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days
Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
99281|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days
Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
99282|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days
Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
99283|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days
Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
99284|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days
Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
99285|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days
Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
99286|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days
Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
99287|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days
Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
99294|NCT01786161|P1|Participant Flow|Vancomycin With Continuous Infusion|"continuous 24 hours intravenous infusion
Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
99295|NCT01786161|O2|Outcome|Intermittent Infusion|"infusion rate 1000mg/hr
Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
99296|NCT01786161|O1|Outcome|Vancomycin Continous Infusion|"continuous 24 hours intravenous infusion
Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
99297|NCT01786161|O2|Outcome|Intermittent Infusion|"infusion rate 1000mg/hr
Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
99298|NCT01786161|O1|Outcome|Vancomycin Continous Infusion|"continuous 24 hours intravenous infusion
Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
99299|NCT01786161|O2|Outcome|Vancomycin With Intermittent Dose Interval|"infusion rate 1000mg/hr
Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
99300|NCT01786161|O1|Outcome|Vancomycin With Continuous Infusion|"continuous 24 hours intravenous infusion
Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
99301|NCT01786161|E2|Reported Event|Intermittent Infusion|"infusion rate 1000mg/hr
Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
99302|NCT01786161|E1|Reported Event|Vancomycin Continous Infusion|"continuous 24 hours intravenous infusion
Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
99303|NCT01786109|B4|Baseline|Total|Total of all reporting groups
99304|NCT01786109|B3|Baseline|Placebo|One dose of placebo will be taken orally with water.
99305|NCT01786109|B2|Baseline|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
99306|NCT01786109|B1|Baseline|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
99307|NCT01786109|P3|Participant Flow|Placebo|One dose of placebo will be taken orally with water.
99308|NCT01786109|P2|Participant Flow|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
99309|NCT01786109|P1|Participant Flow|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
99310|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
99311|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
99312|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
99313|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
99314|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
99315|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
99316|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
99317|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
99318|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
99319|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
99320|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
99321|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
99322|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
99323|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
99324|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
99325|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
99326|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
99327|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
99333|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
99334|NCT01786109|E3|Reported Event|Placebo|One dose of placebo will be taken orally with water.
99335|NCT01786109|E2|Reported Event|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
99336|NCT01786109|E1|Reported Event|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
99337|NCT01785875|B1|Baseline|Etelcalcetide|All participants received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks during the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99338|NCT01785875|P3|Participant Flow|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99339|NCT01785875|P2|Participant Flow|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99340|NCT01785875|P1|Participant Flow|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99341|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99342|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99343|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99344|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99345|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99346|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99347|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99348|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99349|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99350|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99351|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99352|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99353|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99354|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99355|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99356|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99357|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99358|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99359|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99576|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99360|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99361|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99362|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99363|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99364|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99365|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99366|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99367|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99368|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99369|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99370|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99371|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99372|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99413|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
99373|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99374|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99375|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99376|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99377|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99378|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99681|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
99379|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99380|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99381|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99382|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99383|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99384|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99385|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99386|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99387|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99388|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99389|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99390|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99391|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99392|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99393|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99394|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99395|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99396|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99397|NCT01785875|O1|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99682|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99398|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99399|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99400|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99401|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99402|NCT01785875|E4|Reported Event|Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99403|NCT01785875|E3|Reported Event|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99404|NCT01785875|E2|Reported Event|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99405|NCT01785875|E1|Reported Event|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
99406|NCT01785849|B3|Baseline|Total|Total of all reporting groups
99407|NCT01785849|B2|Baseline|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
99408|NCT01785849|B1|Baseline|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
99409|NCT01785849|P2|Participant Flow|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
99410|NCT01785849|P1|Participant Flow|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
99411|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
99412|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
99414|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
99415|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
99416|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
99417|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
99418|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
99419|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
99420|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
99421|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
99422|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
100853|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
99423|NCT01785849|E2|Reported Event|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
99424|NCT01785849|E1|Reported Event|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
99425|NCT01785628|B3|Baseline|Total|Total of all reporting groups
99426|NCT01785628|B2|Baseline|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
99427|NCT01785628|B1|Baseline|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
99428|NCT01785628|P2|Participant Flow|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
99429|NCT01785628|P1|Participant Flow|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
99430|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
99431|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
99432|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
99433|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
99434|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
99435|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
99436|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
99437|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
99438|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
99439|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
99440|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
99441|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
99442|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
99443|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
99444|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
99445|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
99446|NCT01785628|E2|Reported Event|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
99447|NCT01785628|E1|Reported Event|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
99448|NCT01785615|B4|Baseline|Total|Total of all reporting groups
99449|NCT01785615|B3|Baseline|Healthy Participants|
99450|NCT01785615|B2|Baseline|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99451|NCT01785615|B1|Baseline|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99452|NCT01785615|P4|Participant Flow|Metabolic Syndrome Women|These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99453|NCT01785615|P3|Participant Flow|Healthy Women|Women without metabolic syndrome
99454|NCT01785615|P2|Participant Flow|Sugar Pill|"44 women with metabolic syndrome randomized to placebo for 6 weeks
Placebo : 80mg"
99455|NCT01785615|P1|Participant Flow|Atorvastatin|"44 women with metabolic syndrome randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99456|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99457|NCT01785615|O1|Outcome|Healthy Women|
99458|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99459|NCT01785615|O1|Outcome|Healthy Women|
99460|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99462|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99463|NCT01785615|O1|Outcome|Healthy Women|
99464|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99465|NCT01785615|O1|Outcome|Healthy Women|
99466|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99467|NCT01785615|O1|Outcome|Healthy Women|
99468|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99469|NCT01785615|O1|Outcome|Healthy Women|
99470|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99471|NCT01785615|O1|Outcome|Healthy Women|
99472|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99473|NCT01785615|O1|Outcome|Healthy Women|
99474|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99475|NCT01785615|O1|Outcome|Healthy Women|
99476|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99477|NCT01785615|O1|Outcome|Healthy Women|
99478|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99479|NCT01785615|O1|Outcome|Healthy Women|
99480|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99481|NCT01785615|O1|Outcome|Healthy Women|
99482|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99483|NCT01785615|O1|Outcome|Healthy Women|
99484|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99485|NCT01785615|O1|Outcome|Healthy Women|
99486|NCT01785615|O2|Outcome|Metabolic Syndrome Women|These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
99487|NCT01785615|O1|Outcome|Healthy Women|Women without metabolic syndrome
99488|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99489|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99490|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99491|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99492|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99493|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99494|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99495|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99496|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99497|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99498|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99499|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99500|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99501|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99502|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99503|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99504|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99505|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99506|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99507|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99508|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99509|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99510|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo: 80mg"
99511|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin: 80mg"
99512|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99513|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99514|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99515|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99516|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99517|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99518|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99519|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99520|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99521|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99522|NCT01785615|E2|Reported Event|Sugar Pill|"44 women randomized to placebo for 6 weeks
Placebo : 80mg"
99523|NCT01785615|E1|Reported Event|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks
Atorvastatin : 80mg"
99524|NCT01785602|B3|Baseline|Total|Total of all reporting groups
99525|NCT01785602|B2|Baseline|Placebo|Participants received matching placebo to QAW039.
99526|NCT01785602|B1|Baseline|QAW039|Participants received QAW039 450 mg daily by mouth.
99527|NCT01785602|P2|Participant Flow|Placebo|Participants received matching placebo to QAW039.
99528|NCT01785602|P1|Participant Flow|QAW039|Participants received QAW039 450 mg daily by mouth.
99529|NCT01785602|O2|Outcome|Placebo|Participants received matching placebo to QAW039.
99530|NCT01785602|O1|Outcome|QAW039|Participants received QAW039 450 mg daily by mouth.
99531|NCT01785602|O2|Outcome|Placebo|Participants received matching placebo to QAW039.
99532|NCT01785602|O1|Outcome|QAW039|Participants received QAW039 450 mg daily by mouth.
99533|NCT01785602|E2|Reported Event|Placebo|Participants received matching placebo to QAW039.
99534|NCT01785602|E1|Reported Event|QAW039|Participants received QAW039 450 mg daily by mouth.
99535|NCT01785524|B3|Baseline|Total|Total of all reporting groups
99577|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99536|NCT01785524|B2|Baseline|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
99537|NCT01785524|B1|Baseline|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
99538|NCT01785524|P2|Participant Flow|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
99539|NCT01785524|P1|Participant Flow|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
99540|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
99565|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99566|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
107464|NCT01749501|P1|Participant Flow|Rocorium|"0.6 mg/kg once
Rocuronium: 0.6 mg/Kg once"
99541|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
99542|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
99543|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
99683|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99544|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
99545|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
99546|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
99547|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
99548|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
99549|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
99550|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
99551|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
99684|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99552|NCT01785524|E2|Reported Event|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
99553|NCT01785524|E1|Reported Event|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
99554|NCT01785472|B4|Baseline|Total|Total of all reporting groups
99555|NCT01785472|B3|Baseline|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99556|NCT01785472|B2|Baseline|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99557|NCT01785472|B1|Baseline|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99558|NCT01785472|P3|Participant Flow|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99559|NCT01785472|P2|Participant Flow|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99560|NCT01785472|P1|Participant Flow|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99561|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99562|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99563|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99564|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99943|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
99567|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99568|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99569|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99570|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99571|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99572|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99573|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99574|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99575|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99578|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99579|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99580|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99581|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99582|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99583|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99584|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99585|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99586|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99587|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99588|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99589|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99590|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99591|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99592|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99593|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99594|NCT01785472|O2|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99595|NCT01785472|O1|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99596|NCT01785472|O2|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
99597|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
99598|NCT01785472|E3|Reported Event|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily
99599|NCT01785472|E2|Reported Event|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
99600|NCT01785472|E1|Reported Event|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily
99601|NCT01785160|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir The two treatments were separated by washout period of at least 7 days.
99602|NCT01785160|P1|Participant Flow|Overall Study|Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir. The two treatments were separated by washout period of at least 7 days.
99603|NCT01785160|O2|Outcome|Raltegravir + Faldaprevir|"Raltegravir coated tablets and Faldaprevir soft gelatin capsules
Oral with 240 mL of water Day 1: 400 mg raltegravir twice daily and 240 mg faldaprevir twice daily (loading dose) Days 2 to 5: 400 mg raltegravir twice daily and 240 mg faldaprevir once daily Day 6: 400 mg raltegravir once daily and 240 mg faldaprevir once daily"
99604|NCT01785160|O1|Outcome|Raltegravir|"Raltegravir coated tablets
Oral with 240 mL of water Days 1 to 3: 400 mg raltegravir twice daily Day 4: 400 mg raltegravir once daily"
99643|NCT01784965|O2|Outcome|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
99605|NCT01785160|O2|Outcome|Raltegravir + Faldaprevir|"Raltegravir coated tablets and Faldaprevir soft gelatin capsules
Oral with 240 mL of water Day 1: 400 mg raltegravir twice daily and 240 mg faldaprevir twice daily (loading dose) Days 2 to 5: 400 mg raltegravir twice daily and 240 mg faldaprevir once daily Day 6: 400 mg raltegravir once daily and 240 mg faldaprevir once daily"
99606|NCT01785160|O1|Outcome|Raltegravir|"Raltegravir coated tablets
Oral with 240 mL of water Days 1 to 3: 400 mg raltegravir twice daily Day 4: 400 mg raltegravir once daily"
99607|NCT01785160|E2|Reported Event|Raltegravir + Faldaprevir|"coated tablets and soft gelatine capsule, oral administration with 240 ml water
Raltegravir: low dose oral administration
Faldaprevir: medium dose oral administration"
99608|NCT01785160|E1|Reported Event|Raltegravir|"coated tablets, oral administration with 240 ml water
Raltegravir: low dose oral administration"
99609|NCT01785134|B3|Baseline|Total|Total of all reporting groups
99610|NCT01785134|B2|Baseline|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum
Omentectomy
Gastric bypass operation"
99611|NCT01785134|B1|Baseline|Control|"Gastric bypass operation without omentectomy.
Gastric bypass operation"
99612|NCT01785134|P2|Participant Flow|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum
Omentectomy
Gastric bypass operation"
99613|NCT01785134|P1|Participant Flow|Control|"Gastric bypass operation without omentectomy.
Gastric bypass operation"
99614|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum
Omentectomy
Gastric bypass operation"
99615|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.
Gastric bypass operation"
99616|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum
Omentectomy
Gastric bypass operation"
99617|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.
Gastric bypass operation"
99618|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum
Omentectomy
Gastric bypass operation"
99619|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.
Gastric bypass operation"
99620|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum
Omentectomy
Gastric bypass operation"
99621|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.
Gastric bypass operation"
99622|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum
Omentectomy
Gastric bypass operation"
99623|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.
Gastric bypass operation"
99624|NCT01785134|E2|Reported Event|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum
Omentectomy
Gastric bypass operation"
99625|NCT01785134|E1|Reported Event|Control|"Gastric bypass operation without omentectomy.
Gastric bypass operation"
99626|NCT01785095|B1|Baseline|Follicle Stimulating Hormone|
99627|NCT01785095|P1|Participant Flow|Follicle Stimulation Hormone|"FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.
FSH (Follicle Stimulating Hormone)"
99628|NCT01785095|O2|Outcome|Second Cycle|Second treatment cycle after 1 month of wash out.
99629|NCT01785095|O1|Outcome|First Cycle|First treatment cycle.
99630|NCT01785095|O2|Outcome|Second Cycle|Second treatment cycle performed after 1 month of wash out.
99631|NCT01785095|O1|Outcome|First Cycle|First treatment cycle.
99632|NCT01785095|O1|Outcome|Follicle Stimulationg Hormone|
99633|NCT01785095|E1|Reported Event|Follicle Stimulating Hormone|
99634|NCT01784965|B3|Baseline|Total|Total of all reporting groups
99635|NCT01784965|B2|Baseline|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
99636|NCT01784965|B1|Baseline|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
99637|NCT01784965|P2|Participant Flow|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
99638|NCT01784965|P1|Participant Flow|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
99639|NCT01784965|O2|Outcome|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
99640|NCT01784965|O1|Outcome|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
99641|NCT01784965|O2|Outcome|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
99642|NCT01784965|O1|Outcome|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
99679|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99644|NCT01784965|O1|Outcome|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
99645|NCT01784965|E2|Reported Event|Placebo|0/33 0/33 0/33 0/33 0/33
99646|NCT01784965|E1|Reported Event|Liraglutide|Intolerable gastrointestinal side effects 3/35 injection site reaction 2/35 pneumonia 1/35 gallstone 1/35 fall 1/35
99647|NCT01784666|B4|Baseline|Total|Total of all reporting groups
99648|NCT01784666|B3|Baseline|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks
Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99649|NCT01784666|B2|Baseline|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks
Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.
Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99650|NCT01784666|B1|Baseline|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)
Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99651|NCT01784666|P3|Participant Flow|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks
Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99652|NCT01784666|P2|Participant Flow|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks
Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.
Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99653|NCT01784666|P1|Participant Flow|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)
Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99758|NCT01783886|E2|Reported Event|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
99654|NCT01784666|O3|Outcome|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks
Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99655|NCT01784666|O2|Outcome|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks
Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.
Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99656|NCT01784666|O1|Outcome|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)
Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99657|NCT01784666|E3|Reported Event|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks
Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99680|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99658|NCT01784666|E2|Reported Event|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks
Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.
Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99659|NCT01784666|E1|Reported Event|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)
Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
99660|NCT01784614|B1|Baseline|Overall|"Single dose of 0.1 mg LY2624803 oral solution plus 1 placebo capsule, one 1.0, 3.0 or 6.0 mg LY2624803 capsule plus placebo solution administered orally in up to 2 of 4 periods or 1 placebo capsule plus placebo solution administered orally in up to 1 of 4 periods.
There was at least 7 days washout between each period."
99661|NCT01784614|P8|Participant Flow|Cohort 8|"Period 1: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.
Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 4: Single dose of 1.0 mg LY2624803 solution plus 1 placebo capsule administered orally.
There was at least 7 days washout between each period."
99662|NCT01784614|P7|Participant Flow|Cohort 7|"Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 2: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.
Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.
Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.
There was at least 7 days washout between each period."
99663|NCT01784614|P6|Participant Flow|Cohort 6|"Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.
Period 3: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.
Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.
There was at least 7 days washout between each period."
99664|NCT01784614|P5|Participant Flow|Cohort 5|"Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.
Period 2: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.
There was at least 7 days washout between each period."
99665|NCT01784614|P4|Participant Flow|Cohort 4|"Period 1: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 4: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.
There was at least 7 days washout between each period."
99666|NCT01784614|P3|Participant Flow|Cohort 3|"Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 2: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.
Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.
There was at least 7 days washout between each period."
99667|NCT01784614|P2|Participant Flow|Cohort 2|"Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.
Period 3: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.
There was at least 7 days washout between each period."
99668|NCT01784614|P1|Participant Flow|Cohort 1|"Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.
Period 2: Single dose of one 1.0 milligram (mg) LY2624803 capsule plus placebo solution administered orally.
Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.
Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.
There was at least 7 days washout between each period."
99669|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
99670|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
99671|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
99672|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4
99673|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
99674|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
99675|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
99676|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4
99677|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99678|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99814|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99685|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99686|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
99687|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99688|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99689|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99690|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99691|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
99692|NCT01784614|E9|Reported Event|6 mg LY2624803 - Period 4|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
99693|NCT01784614|E8|Reported Event|3.0 mg LY2624803 - Period 4|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
99694|NCT01784614|E7|Reported Event|1.0 mg LY2624803 - Period 4|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
99695|NCT01784614|E6|Reported Event|0.1 mg LY2624803 - Period 4|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4.
99696|NCT01784614|E5|Reported Event|Placebo - Periods 1-3|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99697|NCT01784614|E4|Reported Event|6.0 mg LY2624803 - Periods 1-3|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99698|NCT01784614|E3|Reported Event|3.0 mg LY2624803 - Periods 1-3|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99699|NCT01784614|E2|Reported Event|1.0 mg LY2624803 - Periods 1-3|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
99700|NCT01784614|E1|Reported Event|0.1 mg LY2624803 - Periods 1-3|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
99701|NCT01783938|B3|Baseline|Total|Total of all reporting groups
99702|NCT01783938|B2|Baseline|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99718|NCT01783912|B2|Baseline|Attention Control Group|"This arm of the project will address the following question:
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?
Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
99935|NCT01783496|B2|Baseline|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
99936|NCT01783496|B1|Baseline|Framed Tip|Treatment with Thermage CPT Framed Tip
99703|NCT01783938|B1|Baseline|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99704|NCT01783938|P2|Participant Flow|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99705|NCT01783938|P1|Participant Flow|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99736|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
99737|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
99780|NCT01783821|B2|Baseline|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
99706|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99707|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99708|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99709|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99710|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99711|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99712|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99738|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
99739|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
99812|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99713|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99714|NCT01783938|E2|Reported Event|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99715|NCT01783938|E1|Reported Event|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
99716|NCT01783912|B4|Baseline|Total|Total of all reporting groups
99717|NCT01783912|B3|Baseline|Motivated Smokers Comparison Group|"This arm of the project will address the following question:
Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
99937|NCT01783496|P6|Participant Flow|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
99719|NCT01783912|B1|Baseline|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).
Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
99720|NCT01783912|P3|Participant Flow|Motivated Smokers Comparison Group|"This arm of the project will address the following question:
Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
99721|NCT01783912|P2|Participant Flow|Attention Control Group|"This arm of the project will address the following question:
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?
Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
99740|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
99741|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
100854|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
99722|NCT01783912|P1|Participant Flow|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).
Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
99723|NCT01783912|O3|Outcome|Motivated Smokers Comparison Group|"This arm of the project will address the following question:
Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
99724|NCT01783912|O2|Outcome|Attention Control Group|"This arm of the project will address the following question:
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?
Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
99725|NCT01783912|O1|Outcome|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).
Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
99726|NCT01783912|E3|Reported Event|Motivated Smokers Comparison Group|"This arm of the project will address the following question:
Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
99757|NCT01783886|E3|Reported Event|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
99938|NCT01783496|P5|Participant Flow|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
99727|NCT01783912|E2|Reported Event|Attention Control Group|"This arm of the project will address the following question:
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?
Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
99728|NCT01783912|E1|Reported Event|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).
Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
99729|NCT01783886|B4|Baseline|Total|Total of all reporting groups
99730|NCT01783886|B3|Baseline|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
99731|NCT01783886|B2|Baseline|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
99732|NCT01783886|B1|Baseline|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) 2Q4 over 48 weeks.
99733|NCT01783886|P3|Participant Flow|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
99734|NCT01783886|P2|Participant Flow|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
99735|NCT01783886|P1|Participant Flow|Intravitreal Aflibercept Injection 2Q4|Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
99778|NCT01783860|E1|Reported Event|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month
Doxycycline :"
99742|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
99743|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
99744|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
99745|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
99746|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
99747|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
99748|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
99749|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
99750|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
99751|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
99752|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
99753|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
99754|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
99755|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
99756|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
99939|NCT01783496|P4|Participant Flow|Total Tip|Treatment with the Thermage CPT Total tip
99759|NCT01783886|E1|Reported Event|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
99760|NCT01783860|B3|Baseline|Total|Total of all reporting groups
99761|NCT01783860|B2|Baseline|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
Azithromycin :"
99762|NCT01783860|B1|Baseline|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month
Doxycycline :"
99763|NCT01783860|P2|Participant Flow|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
Azithromycin :"
99764|NCT01783860|P1|Participant Flow|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month
Doxycycline :"
99765|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
Azithromycin :"
99766|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month
Doxycycline :"
99767|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
Azithromycin :"
99768|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month
Doxycycline :"
99769|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
Azithromycin :"
99770|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month
Doxycycline :"
99771|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
Azithromycin :"
99772|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month
Doxycycline :"
99773|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
Azithromycin :"
99774|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month
Doxycycline :"
99775|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
Azithromycin :"
99776|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month
Doxycycline :"
99777|NCT01783860|E2|Reported Event|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
Azithromycin :"
99779|NCT01783821|B3|Baseline|Total|Total of all reporting groups
99781|NCT01783821|B1|Baseline|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
99782|NCT01783821|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
99783|NCT01783821|P1|Participant Flow|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
99784|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
99785|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
99786|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
99787|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
99788|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
99789|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
99790|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
99791|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
99792|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
99793|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
99794|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
99940|NCT01783496|P3|Participant Flow|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip Using Staggered-Pass Technique
99795|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
99796|NCT01783821|E2|Reported Event|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
99797|NCT01783821|E1|Reported Event|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
99798|NCT01783730|B1|Baseline|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99799|NCT01783730|P1|Participant Flow|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99800|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99801|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99802|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99803|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99804|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99805|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99806|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99807|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99808|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99809|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99810|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99811|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
100855|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
99815|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99816|NCT01783730|E1|Reported Event|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
99817|NCT01783678|B7|Baseline|Total|Total of all reporting groups
99818|NCT01783678|B6|Baseline|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
99819|NCT01783678|B5|Baseline|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
99820|NCT01783678|B4|Baseline|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
99821|NCT01783678|B3|Baseline|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
99822|NCT01783678|B2|Baseline|Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
99823|NCT01783678|B1|Baseline|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99824|NCT01783678|P6|Participant Flow|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
99825|NCT01783678|P5|Participant Flow|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
99826|NCT01783678|P4|Participant Flow|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
99827|NCT01783678|P3|Participant Flow|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
99828|NCT01783678|P2|Participant Flow|Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
99829|NCT01783678|P1|Participant Flow|Genotype 2 Treatment-naive|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99830|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
99831|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
99832|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
99941|NCT01783496|P2|Participant Flow|Pattern Tip|Treatment with the Thermage CPT Pattern Tip Using Super-Pass Technique
99833|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
99834|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99835|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99836|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
99837|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99838|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
99839|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
99840|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
99841|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
99842|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99843|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99844|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
99845|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99846|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
99847|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
99848|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
99849|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
99850|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99851|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99852|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
99853|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99854|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
99855|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
99856|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
99857|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
99858|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99859|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99860|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
99861|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99862|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
99863|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
99864|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
99865|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
99866|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99867|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99868|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
99869|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99870|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
99871|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
99872|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
99873|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
99874|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
100516|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
99875|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99876|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
99877|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99878|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
99879|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
99880|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
99881|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
99882|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99883|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99884|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
99885|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99886|NCT01783678|O3|Outcome|Genotype 1/3/4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
99887|NCT01783678|O2|Outcome|Genotype 2/3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
99888|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99889|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
99890|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
99891|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
99892|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
99893|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99894|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
99895|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
99896|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99897|NCT01783678|E3|Reported Event|Genotype 1/3/4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
99898|NCT01783678|E2|Reported Event|Genotype 2/3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
99899|NCT01783678|E1|Reported Event|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
99900|NCT01783639|B1|Baseline|Arm 1|"Device: WIRION™ Embolic Protection System
Interventions: Carotid Artery Stent
Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
99901|NCT01783639|P1|Participant Flow|WIRION|"Device: WIRION™ Embolic Protection System
Interventions: Carotid Artery Stent
Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
99902|NCT01783639|O1|Outcome|Arm 1|"Device: WIRION™ Embolic Protection System
Interventions: Carotid Artery Stent
Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
99963|NCT01783496|E4|Reported Event|Total Tip|"Treatment with the Thermage CPT Total tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
99903|NCT01783639|E1|Reported Event|WIRION|"Device: WIRION™ Embolic Protection System
Interventions: Carotid Artery Stent
Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
99904|NCT01783561|B3|Baseline|Total|Total of all reporting groups
99905|NCT01783561|B2|Baseline|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
99906|NCT01783561|B1|Baseline|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
99907|NCT01783561|P2|Participant Flow|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
99908|NCT01783561|P1|Participant Flow|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
99909|NCT01783561|O2|Outcome|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
99942|NCT01783496|P1|Participant Flow|Framed Tip|Treatment with Thermage CPT Framed Tip
99910|NCT01783561|O1|Outcome|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
99911|NCT01783561|O2|Outcome|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
99912|NCT01783561|O1|Outcome|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
99913|NCT01783561|E2|Reported Event|Routine Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
99914|NCT01783561|E1|Reported Event|Early Caffeine|"Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose."
99915|NCT01783548|B3|Baseline|Total|Total of all reporting groups
99916|NCT01783548|B2|Baseline|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
99917|NCT01783548|B1|Baseline|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
99918|NCT01783548|P2|Participant Flow|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
99919|NCT01783548|P1|Participant Flow|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
99920|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
99921|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
99922|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
99923|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
99924|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
99925|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
99926|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
99927|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
99928|NCT01783548|E2|Reported Event|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
99929|NCT01783548|E1|Reported Event|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
99930|NCT01783496|B7|Baseline|Total|Total of all reporting groups
99931|NCT01783496|B6|Baseline|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
99932|NCT01783496|B5|Baseline|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
99933|NCT01783496|B4|Baseline|Total Tip|Treatment with the Thermage CPT Total tip
99934|NCT01783496|B3|Baseline|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
99944|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
99945|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
99946|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
99947|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
99948|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
99949|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
99950|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
99951|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
99952|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
99953|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
99954|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
99955|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
99956|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
99957|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
99958|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
99959|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
99960|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
99961|NCT01783496|E6|Reported Event|Total and Patterned Tip|"Split face treatment with the Thermage CPT Total and Patterned tips
Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
99962|NCT01783496|E5|Reported Event|Framed and Patterned Tip|"Split face treatment with the Thermage CPT Framed and Patterned tips
Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
99964|NCT01783496|E3|Reported Event|Pattern Tip Group 2|"Treatment with the Thermage CPT Pattern tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
99965|NCT01783496|E2|Reported Event|Pattern Tip|"Treatment with the Thermage CPT Pattern Tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
99966|NCT01783496|E1|Reported Event|Framed Tip|"Treatment with Thermage CPT Framed Tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
99967|NCT01783470|B1|Baseline|All Participants|All participants randomized to placebo or drug first then received the other treatment second.
99968|NCT01783470|P2|Participant Flow|beta3-adrenergic Receptor (AR) Agonist Then Placebo|Participants administered an oral beta3-AR agonist followed by administration of the PET tracer FDG and then PET/CT scanning. On a subsequent day that was at least 48 hours later (for washout purposes) these subjects then received placebo.
99969|NCT01783470|P1|Participant Flow|Placebo Then beta3-adrenergic Receptor (AR) Agonist|Participants administered a lactose-based oral placebo followed by administration of the PET tracer FDG and then PET/CT scanning. On a subsequent day that was at least 48 hours later (for washout purposes) these subjects then received drug.
99970|NCT01783470|O2|Outcome|beta3-adrenergic Receptor (AR)|
99971|NCT01783470|O1|Outcome|Placebo|"lactose
Placebo"
99972|NCT01783470|E3|Reported Event|Mild Cold Exposure|2 hours while wearing a cooling vest with water set to 14-16 C. This arm was before randomization and had 15 participants.
99973|NCT01783470|E2|Reported Event|beta3-adrenergic Receptor Agonist|"single dose
beta3-adrenergic receptor agonist: single dose"
99974|NCT01783470|E1|Reported Event|Placebo|"lactose
Placebo"
99975|NCT01783418|B3|Baseline|Total|Total of all reporting groups
99976|NCT01783418|B2|Baseline|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99977|NCT01783418|B1|Baseline|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99978|NCT01783418|P2|Participant Flow|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99979|NCT01783418|P1|Participant Flow|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99980|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99981|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99982|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99983|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99984|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99985|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99986|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99987|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99988|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99989|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99990|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99991|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99992|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99993|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99994|NCT01783418|E2|Reported Event|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99995|NCT01783418|E1|Reported Event|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
99996|NCT01783236|B3|Baseline|Total|Total of all reporting groups
99997|NCT01783236|B2|Baseline|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.
IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
99998|NCT01783236|B1|Baseline|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
99999|NCT01783236|P2|Participant Flow|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.
IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
100000|NCT01783236|P1|Participant Flow|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
100001|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.
IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
100002|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
100003|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.
IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
100004|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
100856|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
100005|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.
IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
100006|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
100007|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.
IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
100008|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
100009|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.
IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
100010|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
100011|NCT01783236|E2|Reported Event|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.
IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
100012|NCT01783236|E1|Reported Event|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.
Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
100013|NCT01783080|B1|Baseline|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.
Behavioral Activation for return to work: See Arm Description"
100014|NCT01783080|P1|Participant Flow|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.
Behavioral Activation for return to work: See Arm Description"
100027|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
100028|NCT01783054|E1|Reported Event|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
100029|NCT01783015|B3|Baseline|Total|Total of all reporting groups
100015|NCT01783080|O1|Outcome|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.
Behavioral Activation for return to work: See Arm Description"
100016|NCT01783080|O1|Outcome|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.
Behavioral Activation for return to work: See Arm Description"
100017|NCT01783080|O1|Outcome|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.
Behavioral Activation for return to work: See Arm Description"
100044|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100018|NCT01783080|O1|Outcome|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.
Behavioral Activation for return to work: See Arm Description"
100019|NCT01783080|E1|Reported Event|Behavioral Activation for Return to Work|"BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.
Behavioral Activation for return to work: See Arm Description"
100020|NCT01783054|B1|Baseline|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
100021|NCT01783054|P1|Participant Flow|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
100022|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
100023|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
100024|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
100025|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
100026|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
107465|NCT01749501|O2|Outcome|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
100030|NCT01783015|B2|Baseline|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100031|NCT01783015|B1|Baseline|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100032|NCT01783015|P3|Participant Flow|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100033|NCT01783015|P2|Participant Flow|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100034|NCT01783015|P1|Participant Flow|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100035|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100036|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100037|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100038|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100039|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100040|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100041|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100042|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100043|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100857|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
100045|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100046|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100047|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100048|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100049|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100050|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100051|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100052|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100053|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100054|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100055|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100056|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100057|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100058|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100059|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100060|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100061|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100062|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100063|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100064|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100065|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100066|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100067|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100068|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100069|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100070|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100071|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100072|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100073|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100074|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100075|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100076|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100077|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100078|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100079|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100080|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100081|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100082|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100083|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100084|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100085|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100086|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100858|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
100087|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100088|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100089|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100090|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100091|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100092|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100093|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100094|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100095|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100096|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100097|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100098|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100099|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100100|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100101|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100102|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100103|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100104|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100105|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100106|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100107|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100108|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100109|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100110|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100111|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100112|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100113|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100114|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100115|NCT01783015|E3|Reported Event|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
100116|NCT01783015|E2|Reported Event|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
100117|NCT01783015|E1|Reported Event|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
100118|NCT01782898|B3|Baseline|Total|Total of all reporting groups
100119|NCT01782898|B2|Baseline|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
100120|NCT01782898|B1|Baseline|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
100121|NCT01782898|P2|Participant Flow|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
100122|NCT01782898|P1|Participant Flow|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
100123|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
100158|NCT01782872|B3|Baseline|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100124|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
100125|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
100126|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
100127|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
100128|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
100129|NCT01782898|E2|Reported Event|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
100130|NCT01782898|E1|Reported Event|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
100131|NCT01782885|B3|Baseline|Total|Total of all reporting groups
100132|NCT01782885|B2|Baseline|Intra-articular Injection of PRP|Intra-articular injection of PRP: Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks treatment).
100133|NCT01782885|B1|Baseline|Acetaminophen|Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) during 6 weeks.
100134|NCT01782885|P2|Participant Flow|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
100135|NCT01782885|P1|Participant Flow|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
100136|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
100137|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
100138|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
100139|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
100140|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
100141|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
100142|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
100143|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
100674|NCT01780974|P1|Participant Flow|Placebo|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
100144|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
100145|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
100146|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
100147|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
100148|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
100149|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
100150|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
100151|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
100152|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
100153|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
100154|NCT01782885|E2|Reported Event|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
100155|NCT01782885|E1|Reported Event|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
100156|NCT01782872|B5|Baseline|Total|Total of all reporting groups
100157|NCT01782872|B4|Baseline|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
100859|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
100159|NCT01782872|B2|Baseline|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100160|NCT01782872|B1|Baseline|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
100161|NCT01782872|P4|Participant Flow|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
100162|NCT01782872|P3|Participant Flow|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100163|NCT01782872|P2|Participant Flow|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100164|NCT01782872|P1|Participant Flow|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
100165|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
100166|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100167|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100168|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
100169|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
100170|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100171|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100172|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
100173|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
100174|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100175|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100176|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
100177|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
100178|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100179|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100180|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
100181|NCT01782872|E4|Reported Event|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
100182|NCT01782872|E3|Reported Event|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100183|NCT01782872|E2|Reported Event|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
100184|NCT01782872|E1|Reported Event|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
100185|NCT01782859|B3|Baseline|Total|Total of all reporting groups
100186|NCT01782859|B2|Baseline|Prednisone/Hydrocortisone|"Steroid group will receive the following:
20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
100187|NCT01782859|B1|Baseline|Placebo|"Control group
Placebo (for Prednisone)"
100258|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100188|NCT01782859|P2|Participant Flow|Prednisone/Hydrocortisone|"Steroid group will receive the following:
20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
100189|NCT01782859|P1|Participant Flow|Placebo|"Control group
Placebo (for Prednisone)"
100190|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:
20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
Prednisone
Hydrocortisone"
100191|NCT01782859|O1|Outcome|Placebo|"Control group
Placebo (for Prednisone)"
100192|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:
20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
100193|NCT01782859|O1|Outcome|Placebo|"Control group
Placebo (for Prednisone)"
100194|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:
20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
100195|NCT01782859|O1|Outcome|Placebo|"Control group
Placebo (for Prednisone)"
100196|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:
20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
100197|NCT01782859|O1|Outcome|Placebo|"Control group
Placebo (for Prednisone)"
100198|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:
20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
100199|NCT01782859|O1|Outcome|Placebo|"Control group
Placebo (for Prednisone)"
100200|NCT01782859|E2|Reported Event|Prednisone/Hydrocortisone|"Steroid group will receive the following:
20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
100201|NCT01782859|E1|Reported Event|Placebo|"Control group
Placebo (for Prednisone)"
100202|NCT01782742|B3|Baseline|Total|Total of all reporting groups
100203|NCT01782742|B2|Baseline|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Placebo"
100204|NCT01782742|B1|Baseline|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100205|NCT01782742|P2|Participant Flow|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Placebo"
100206|NCT01782742|P1|Participant Flow|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100207|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
100208|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100209|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
100210|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100211|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
100212|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100213|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
100214|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100215|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100216|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Placebo"
100217|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100218|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Placebo"
100219|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100220|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Placebo"
101268|NCT01777581|P1|Participant Flow|Milnacipran|Milnacipran, flexibly dosed
100221|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100222|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Placebo"
100223|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100224|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
100225|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100226|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
100227|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100228|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
100229|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100230|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
100231|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100232|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
100233|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100234|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Placebo"
100235|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100236|NCT01782742|E2|Reported Event|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Placebo"
100237|NCT01782742|E1|Reported Event|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.
Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)
Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
100238|NCT01782664|B7|Baseline|Total|Total of all reporting groups
100239|NCT01782664|B6|Baseline|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100240|NCT01782664|B5|Baseline|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100241|NCT01782664|B4|Baseline|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100242|NCT01782664|B3|Baseline|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100243|NCT01782664|B2|Baseline|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100244|NCT01782664|B1|Baseline|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100245|NCT01782664|P6|Participant Flow|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100246|NCT01782664|P5|Participant Flow|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100247|NCT01782664|P4|Participant Flow|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100248|NCT01782664|P3|Participant Flow|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100249|NCT01782664|P2|Participant Flow|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100250|NCT01782664|P1|Participant Flow|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100251|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100252|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100253|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100254|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100255|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100256|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100257|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100259|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100260|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100261|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100262|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100263|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100264|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100265|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100266|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100267|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100268|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100269|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100270|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100271|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100272|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100273|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100274|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100275|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100276|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100277|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100278|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100279|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100280|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100281|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100282|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100283|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100284|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100285|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100286|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100287|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100288|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100289|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100290|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100291|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100292|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100293|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100294|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100295|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100296|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100297|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100298|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100299|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100300|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
101269|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
100301|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100302|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100303|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100304|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100305|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100306|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100307|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100308|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100309|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100310|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100311|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100312|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100313|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100314|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100315|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100316|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100317|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100318|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100319|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100320|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100321|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100322|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100323|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100324|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100325|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100326|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100327|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100328|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100329|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100330|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100331|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100332|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100333|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100334|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100335|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100336|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100337|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100338|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100339|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100340|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100341|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100342|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
101270|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
100343|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100344|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100345|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100346|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100347|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100348|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100349|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100350|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100351|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100352|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100353|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100354|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100355|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100356|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100357|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100358|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100359|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100360|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100361|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100362|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100363|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100364|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100365|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100366|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100367|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100368|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100369|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100370|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100371|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100372|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100373|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100374|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100375|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100376|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100377|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100378|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100379|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100380|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100381|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100382|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100383|NCT01782664|O6|Outcome|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100384|NCT01782664|O5|Outcome|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
101271|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
100385|NCT01782664|O4|Outcome|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100386|NCT01782664|O3|Outcome|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100387|NCT01782664|O2|Outcome|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100388|NCT01782664|O1|Outcome|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100389|NCT01782664|E6|Reported Event|GSK2586184 200 mg OL|Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100390|NCT01782664|E5|Reported Event|GSK2586184 400 mg OL|Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100391|NCT01782664|E4|Reported Event|GSK2586184 400 mg|Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100392|NCT01782664|E3|Reported Event|GSK2586184 200 mg|Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100393|NCT01782664|E2|Reported Event|GSK2586184 100 mg|Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
100394|NCT01782664|E1|Reported Event|Placebo|Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
100395|NCT01782482|B3|Baseline|Total|Total of all reporting groups
100396|NCT01782482|B2|Baseline|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
100397|NCT01782482|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
100398|NCT01782482|P2|Participant Flow|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
100399|NCT01782482|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
100400|NCT01782482|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
100401|NCT01782482|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
100402|NCT01782482|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
100403|NCT01782482|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
100404|NCT01782482|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
100405|NCT01782482|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
100406|NCT01782469|B1|Baseline|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
100407|NCT01782469|P1|Participant Flow|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
100408|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
100409|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
100410|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
100411|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
100412|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
100413|NCT01782469|E1|Reported Event|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
100414|NCT01782326|B3|Baseline|Total|Total of all reporting groups
100415|NCT01782326|B2|Baseline|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100416|NCT01782326|B1|Baseline|QVA149|QVA149 (110/50 μg) once daily
100417|NCT01782326|P2|Participant Flow|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100418|NCT01782326|P1|Participant Flow|QVA149|QVA149 (110/50 μg) once daily
100419|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100420|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100421|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100422|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100423|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100424|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100425|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100426|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100427|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100428|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100429|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100430|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100431|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100432|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100433|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100434|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100435|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100436|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100437|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100438|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100439|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100440|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100441|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100442|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100443|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100444|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100445|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100446|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100447|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100448|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100449|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100450|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100451|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100452|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100453|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100454|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100455|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100456|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100457|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100458|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100459|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100460|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100461|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100462|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100463|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100464|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100465|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100466|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100467|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100468|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100469|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100470|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100471|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100472|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100473|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100474|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
100475|NCT01782326|E2|Reported Event|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
100476|NCT01782326|E1|Reported Event|QVA149|QVA149 (110/50 μg) once daily
100477|NCT01782222|B4|Baseline|Total|Total of all reporting groups
100478|NCT01782222|B3|Baseline|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100479|NCT01782222|B2|Baseline|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100480|NCT01782222|B1|Baseline|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100513|NCT01782222|E1|Reported Event|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100514|NCT01781962|B1|Baseline|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
100481|NCT01782222|P3|Participant Flow|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100482|NCT01782222|P2|Participant Flow|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100483|NCT01782222|P1|Participant Flow|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100484|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100485|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100486|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100487|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100488|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100489|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100490|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
101336|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
100491|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100492|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100493|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100494|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100495|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100496|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100515|NCT01781962|P1|Participant Flow|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
100497|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100498|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100499|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100500|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100501|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100502|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100503|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100504|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100505|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100506|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100507|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100508|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100509|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100510|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches
Placebo: Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)"
100511|NCT01782222|E3|Reported Event|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
Optimal dosage:
The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
100512|NCT01782222|E2|Reported Event|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease
Rotigotine: Rotigotine, transdermal patches:
10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
Optimal dosage:
The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
101272|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
100517|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
100518|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
100519|NCT01781962|E1|Reported Event|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
100520|NCT01781637|B3|Baseline|Total|Total of all reporting groups
100521|NCT01781637|B2|Baseline|Placebo|"Patients will receive placebo.
placebo: subcutaneous injection"
100522|NCT01781637|B1|Baseline|Omalizumab Group|"Patients will receive omalizumab.
Omalizumab: subcutaneous injection"
100523|NCT01781637|P2|Participant Flow|Placebo|"Patients will receive placebo.
placebo: subcutaneous injection"
100524|NCT01781637|P1|Participant Flow|Omalizumab Group|"Patients will receive omalizumab.
Omalizumab: subcutaneous injection"
100525|NCT01781637|O2|Outcome|Placebo|"Patients will receive placebo.
placebo: subcutaneous injection"
100526|NCT01781637|O1|Outcome|Omalizumab Group|"Patients will receive omalizumab.
Omalizumab: subcutaneous injection"
100527|NCT01781637|O2|Outcome|Placebo|"Patients will receive placebo.
placebo: subcutaneous injection"
100528|NCT01781637|O1|Outcome|Omalizumab Group|"Patients will receive omalizumab.
Omalizumab: subcutaneous injection"
100529|NCT01781637|E2|Reported Event|Placebo|"Patients will receive placebo.
placebo: subcutaneous injection"
100530|NCT01781637|E1|Reported Event|Omalizumab Group|"Patients will receive omalizumab.
Omalizumab: subcutaneous injection"
100531|NCT01781481|B1|Baseline|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100532|NCT01781481|P1|Participant Flow|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of Inflammatory Bowel Disease (IBD).
100533|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100534|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100535|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100536|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100537|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100538|NCT01781481|O6|Outcome|Vulnerability Health System Item: Health System Impediments|This item anticipates the problems that the child/youth may encounter in the next 3-6 months in receiving the services he/she requires.
100539|NCT01781481|O5|Outcome|Current Health System Item: Coordination of Care|This item describes the extent to which the different health care providers working with the child are in contact with each other.
100540|NCT01781481|O4|Outcome|Current Health System Item: Organization of Care|This item describes the nature and organization of the health care services that the child is current receiving.
100541|NCT01781481|O3|Outcome|Historical Health System Item: Treatment Experience|This item describes the degree to which the child and family's prior health care experiences have been positive in terms of good outcomes and relationships with health care providers.
100542|NCT01781481|O2|Outcome|Historical Health System Item: Access to Health Care|This item refers to anything in the past that served as an obstacle, hindering the patient's access to healthcare.
100543|NCT01781481|O1|Outcome|Pediatric Intermed: Health System Domain Score|Sum of Pediatric INTERMED health system item scores.
100544|NCT01781481|O2|Outcome|CBCL Externalizing Score in the Non-clinical Range|Children whose scores on the CBCL Externalizing Scale fell below the clinical range.
100545|NCT01781481|O1|Outcome|CBCL Externalizing Score in the Clinical Range.|Children whose scores on the CBCL Externalizing scale fell within the clinical range.
101337|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
100546|NCT01781481|O2|Outcome|CBCL Internalizing Score in the Non-clinical Range|Children's whose scores on the CBCL Internalizing Scale fell below the clinical range.
100547|NCT01781481|O1|Outcome|CBCL Internalizing Score in the Clinical Range.|Children whose scores on the CBCL Internalizing Scale fell within the clinical range.
100548|NCT01781481|O2|Outcome|Subjects With CDI Scores in the Non-clinical Range|Children whose scores on the Children's Depression Inventory fell below the clinical range.
100549|NCT01781481|O1|Outcome|Subjects With CDI Scores in the Clinical Range.|Children whose scores on the Children's Depression Inventory fell within the clinical range.
100550|NCT01781481|O2|Outcome|Subjects With MASC Scores in the Non-clinical Range|Children whose scores on the Multidimensional Anxiety Scale for Children fell below the clinical range.
100551|NCT01781481|O1|Outcome|Subjects With MASC Scores in the Clinical Range.|Children whose scores on the Multidimensional Anxiety Scale for Children fell within the clinical range.
100552|NCT01781481|O3|Outcome|Pediatric INTERMED Caregiver/Family Domain Score|Sum of Pediatric INTERMED Caregiver/Family Domain item scores
100553|NCT01781481|O2|Outcome|Pediatric INTERMED Social Domain Score|Sum of Pediatric INTERMED Social Domain items scores
100554|NCT01781481|O1|Outcome|Pediatric INTERMED Psychological Domain Score|Sum of Pediatric INTERMED Psychological Domain item scores
100555|NCT01781481|O7|Outcome|Vulnerability Biological Item: Complications and Life Threat|This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
100556|NCT01781481|O6|Outcome|Current Biological Item: Therapeutic Complexity|This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.
100557|NCT01781481|O5|Outcome|Current Biological Item: Diagnostic/Therapeutic Challenge|This item refers to the presence of physical symptoms that result in current diagnostic questions or therapeutic challenges.
100558|NCT01781481|O4|Outcome|Current Biological Item: Symptom Severity|This item taps the severity/acuity of the child's current physical symptoms, and the extent to which they impact on current functioning.
100559|NCT01781481|O3|Outcome|Historical Biological Item: Diagnostic Dilemma|This item taps whether or not the child/youth has been seeking care for physical complaints across a substantial portion of their life and whether or not these complaints have been resolved.
100560|NCT01781481|O2|Outcome|Historical Biological Item: Chronicity|This item taps the extent and chronicity of child's physical health issues.
100561|NCT01781481|O1|Outcome|Pediatric INTERMED Biological Domain Score|Sum of all Pediatric INTERMED Biological domain item scores.
100562|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100563|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100564|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100565|NCT01781481|O1|Outcome|Children/Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100566|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100567|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100568|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100569|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100570|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100571|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100572|NCT01781481|O4|Outcome|Greater Than 5 Years|Greater than 5 years since initial IBD diagnosis.
100573|NCT01781481|O3|Outcome|1 Year-5 Years|1 - 5 years since initial IBD diagnosis.
100574|NCT01781481|O2|Outcome|6 Months-1 Year|6 months to 1 year since initial IBD diagnosis.
100575|NCT01781481|O1|Outcome|Less Than 6 Months|Less than 6 months since initial IBD diagnosis.
100576|NCT01781481|O4|Outcome|Disease Severity: Severe|Disease Severity classified as severe
100577|NCT01781481|O3|Outcome|Disease Severity: Moderate|Disease Severity classified as moderate
100578|NCT01781481|O2|Outcome|Disease Severity: Mild|Disease Severity classified as mild
100579|NCT01781481|O1|Outcome|Disease Severity: Remission/Inactive|Disease Severity classified as in remission/inactive
100580|NCT01781481|O3|Outcome|Score of 2 or 3|Rating of 2 (Moderate Vulnerability/Need for Action or Development of an Intervention Plan) on the Pediatric INTERMED item or Rating of 3 (Severe Vulnerability/Need for Immediate Action of Intensive Action/Plans).
100581|NCT01781481|O2|Outcome|Score of 1|Rating of 1 (Mild Vulnerability/Need for watchful waiting or preventive intervention) on Pediatric INTERMED item.
100582|NCT01781481|O1|Outcome|Score of 0|Rating of 0 (No Vulnerability/Need for Action) on Pediatric INTERMED Item
100583|NCT01781481|O5|Outcome|Health Service|Sum of Health Service Domain Item Scores
100584|NCT01781481|O4|Outcome|Family/Caregiver|Sum of Family/Caregiver Domain Item Scores
100585|NCT01781481|O3|Outcome|Social|Sum of Social Domain Item Scores
100586|NCT01781481|O2|Outcome|Psychological|Sum of Psychological Domain Item Scores
100587|NCT01781481|O1|Outcome|Biological|Sum of Biological Domain Item Scores
100588|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100589|NCT01781481|E1|Reported Event|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
100590|NCT01781403|B1|Baseline|Capecitabine, Temozolomide, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.
The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).
Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
100591|NCT01781403|P3|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 75mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.
The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).
Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
100592|NCT01781403|P2|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 60mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.
The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).
Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
100593|NCT01781403|P1|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 45mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.
The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).
Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
100594|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100595|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100596|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100597|NCT01781403|O2|Outcome|Hypermethylated MGMT|MGMT methylation specific PCR: hypermethylated
100598|NCT01781403|O1|Outcome|Unmethylated MGMT|MGMT methylation specific PCR: unmethlyated
100599|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100600|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100601|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100602|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100603|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100604|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100605|NCT01781403|E3|Reported Event|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100606|NCT01781403|E2|Reported Event|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100607|NCT01781403|E1|Reported Event|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).
Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
100608|NCT01781299|B3|Baseline|Total|Total of all reporting groups
100609|NCT01781299|B2|Baseline|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
SurgiMend PRS"
100610|NCT01781299|B1|Baseline|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.
AlloDerm RTU"
100611|NCT01781299|P2|Participant Flow|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
SurgiMend PRS"
100612|NCT01781299|P1|Participant Flow|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.
AlloDerm RTU"
100613|NCT01781299|O2|Outcome|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
SurgiMend PRS"
100614|NCT01781299|O1|Outcome|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.
AlloDerm RTU"
100615|NCT01781299|O2|Outcome|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
SurgiMend PRS"
100616|NCT01781299|O1|Outcome|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.
AlloDerm RTU"
100617|NCT01781299|E2|Reported Event|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
SurgiMend PRS"
101338|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
100618|NCT01781299|E1|Reported Event|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.
AlloDerm RTU"
100619|NCT01781208|B1|Baseline|Ultrasound-based Acoustic Radiation Force Impulse (ARFI)|62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy for known or suspected (non-neoplastic) liver disease were included in this study. Subjects were between 0-18 years of age.
100620|NCT01781208|P1|Participant Flow|Ultrasound-based Acoustic Radiation Force Impulse (ARFI)|"62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy were included. Biopsy was performed for known or suspected (non-neoplastic) liver disease. (One child did not undergo a liver biopsy, so was ineligible and not included in the above total.)
The patients received an additional ultrasound for research purposes that utilized a technique known as ARFI. ARFI, or Acoustic Radiation Force Impulse, uses a transducer which directs sound waves again the liver to measure the stiffness of the tissues."
100621|NCT01781208|O2|Outcome|Children Undergoing Diagnostic ARFI/VTIQ and Fibrosis Scoring|We measured correlation between liver shear wave speed as determined by ARFI/VTIQ and liver histologic fibrosis score.
100622|NCT01781208|O1|Outcome|Children Undergoing Diagnostic ARFI/VTQ and Fibrosis Scoring|We measured correlation between liver shear wave speed as determined by ARFI (VTQ) and liver histologic fibrosis score.
100623|NCT01781208|E1|Reported Event|All Participants|No serious or non-serious adverse events were observed during the study.
100624|NCT01781169|B3|Baseline|Total|Total of all reporting groups
100625|NCT01781169|B2|Baseline|Obese Group|
100626|NCT01781169|B1|Baseline|Normal-weight Group|
100627|NCT01781169|P2|Participant Flow|Normal-weight Group|Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
100628|NCT01781169|P1|Participant Flow|Obese Group|Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
100629|NCT01781169|O2|Outcome|Normal-weight Group|Oral supplementation of vitamin D.
100630|NCT01781169|O1|Outcome|Obese Group|Oral supplementation of vitamin D.
100631|NCT01781169|E2|Reported Event|Obese Group|
100632|NCT01781169|E1|Reported Event|Normal-weight Group|
100633|NCT01781078|B3|Baseline|Total|Total of all reporting groups
100634|NCT01781078|B2|Baseline|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.
ImageReady System implant: Pacemaker and lead(s) implant"
100907|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100635|NCT01781078|B1|Baseline|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
ImageReady System implant: Pacemaker and lead(s) implant"
100636|NCT01781078|P3|Participant Flow|Patients Withdrawn Prior to Randomization|Patients who consented to the study but were withdrawn prior to the randomization.
100637|NCT01781078|P2|Participant Flow|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.
ImageReady System implant: Pacemaker and lead(s) implant"
100638|NCT01781078|P1|Participant Flow|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
ImageReady System implant: Pacemaker and lead(s) implant"
100639|NCT01781078|O1|Outcome|All Subjects Who Underwent an Implant Procedure|All subjects who underwent an implant procedure and reached 91 days of follow-up.
100640|NCT01781078|O2|Outcome|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
ImageReady System implant: Pacemaker and lead(s) implant"
100641|NCT01781078|O1|Outcome|Control Group|"Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups.
ImageReady System implant: Pacemaker and lead(s) implant"
100642|NCT01781078|O2|Outcome|Control Group|"Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups.
ImageReady System implant: Pacemaker and lead(s) implant"
100643|NCT01781078|O1|Outcome|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
ImageReady System implant: Pacemaker and lead(s) implant"
100644|NCT01781078|O1|Outcome|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
ImageReady System implant: Pacemaker and lead(s) implant"
100645|NCT01781078|E2|Reported Event|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.
ImageReady System implant: Pacemaker and lead(s) implant"
100646|NCT01781078|E1|Reported Event|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
ImageReady System implant: Pacemaker and lead(s) implant"
100647|NCT01781026|B1|Baseline|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
100648|NCT01781026|P1|Participant Flow|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
100649|NCT01781026|O1|Outcome|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
100650|NCT01781026|E1|Reported Event|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
100651|NCT01780987|B3|Baseline|Total|Total of all reporting groups
100673|NCT01780974|P2|Participant Flow|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
100652|NCT01780987|B2|Baseline|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
100653|NCT01780987|B1|Baseline|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
100654|NCT01780987|P2|Participant Flow|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
100655|NCT01780987|P1|Participant Flow|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
100656|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
100657|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
100658|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
100659|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
100686|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100660|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
100661|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
100662|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
100663|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
100664|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
100665|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
100666|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
100667|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
100668|NCT01780987|E2|Reported Event|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
100669|NCT01780987|E1|Reported Event|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
100670|NCT01780974|B3|Baseline|Total|Total of all reporting groups
100671|NCT01780974|B2|Baseline|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
100672|NCT01780974|B1|Baseline|Placebo|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
100675|NCT01780974|O2|Outcome|Lipoic Acid Plus Omega-3 Fatty Acids|"Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal.
Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate"
100676|NCT01780974|O1|Outcome|Placebo|"Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal.
Placebo: placebo capsules"
100677|NCT01780974|O2|Outcome|Lipoic Acid Plus Omega-3 Fatty Acids|"Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal.
Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate"
100678|NCT01780974|O1|Outcome|Placebo|"Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal.
Placebo: placebo capsules"
100679|NCT01780974|E2|Reported Event|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
100680|NCT01780974|E1|Reported Event|Placebo|placebo capsules
100681|NCT01780935|B3|Baseline|Total|Total of all reporting groups
100682|NCT01780935|B2|Baseline|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100683|NCT01780935|B1|Baseline|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100684|NCT01780935|P2|Participant Flow|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100685|NCT01780935|P1|Participant Flow|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
101273|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
100687|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100688|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100689|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100690|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100691|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100692|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100693|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100694|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100695|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100696|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100697|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100698|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100699|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100827|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100700|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100701|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100702|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100703|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100704|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100705|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100706|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100707|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100708|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100709|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100710|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100711|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100712|NCT01780935|E2|Reported Event|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
100713|NCT01780935|E1|Reported Event|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
100714|NCT01780922|B1|Baseline|All Study Participants|All study participants: all participants received all interventions
100715|NCT01780922|P6|Participant Flow|Placebo First, Then CLEB, Then LCJC|First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
100716|NCT01780922|P5|Participant Flow|Placebo First, Then LCJC, Then CLEB|First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
100717|NCT01780922|P4|Participant Flow|CLEB First, Then Placebo, Then LCJC|First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
100718|NCT01780922|P3|Participant Flow|CLEB First, Then LCJC, Then Placebo|First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
100719|NCT01780922|P2|Participant Flow|LCJC First, Then Placebo, Then CLEB|First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
101339|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
100720|NCT01780922|P1|Participant Flow|LCJC First, Then CLEB, Then Placebo|First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
100721|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100722|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100723|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100724|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100725|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100726|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100727|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100728|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100729|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100730|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100848|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100731|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100732|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100733|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100734|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100735|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100736|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100737|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100738|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100739|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100740|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100741|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100742|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100743|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100744|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100745|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100746|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100747|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100748|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100749|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100750|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100751|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100752|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100753|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100754|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100755|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100756|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100757|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100849|NCT01780506|E2|Reported Event|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100758|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100759|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100760|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100761|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100762|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100763|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100764|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100765|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100766|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100767|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100768|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100769|NCT01780922|E3|Reported Event|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100770|NCT01780922|E2|Reported Event|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes
Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100771|NCT01780922|E1|Reported Event|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes
Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
100772|NCT01780870|B3|Baseline|Total|Total of all reporting groups
100828|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100773|NCT01780870|B2|Baseline|Weight Loss Group|"Full Meal replacement Protocol
Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
100774|NCT01780870|B1|Baseline|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
100775|NCT01780870|P2|Participant Flow|Weight Loss Group|"Full Meal replacement Protocol
Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
100776|NCT01780870|P1|Participant Flow|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
100777|NCT01780870|O2|Outcome|Weight Loss Group|"Full Meal replacement Protocol
Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
100778|NCT01780870|O1|Outcome|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
100779|NCT01780870|O2|Outcome|Weight Loss Group|"Full Meal replacement Protocol
Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
100780|NCT01780870|O1|Outcome|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
100781|NCT01780870|O2|Outcome|Weight Loss Group|"Full Meal replacement Protocol
Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
100782|NCT01780870|O1|Outcome|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
100783|NCT01780870|E2|Reported Event|Weight Loss Group|"Full Meal replacement Protocol
Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase"
100784|NCT01780870|E1|Reported Event|Control Group|Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
100785|NCT01780584|B4|Baseline|Total|Total of all reporting groups
100786|NCT01780584|B3|Baseline|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
100787|NCT01780584|B2|Baseline|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
100788|NCT01780584|B1|Baseline|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
100789|NCT01780584|P3|Participant Flow|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
100790|NCT01780584|P2|Participant Flow|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
100791|NCT01780584|P1|Participant Flow|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
100792|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
100793|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
100794|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
100795|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
100829|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
101340|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
100796|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
100797|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
100798|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
100799|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
100800|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
100801|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
100802|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
100803|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
100804|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
100805|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
100806|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
100807|NCT01780584|E3|Reported Event|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
100808|NCT01780584|E2|Reported Event|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
100850|NCT01780506|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100851|NCT01780389|B1|Baseline|Milnacipran|Open-label flexibly dosed milnacipran
100809|NCT01780584|E1|Reported Event|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
100810|NCT01780506|B3|Baseline|Total|Total of all reporting groups
100811|NCT01780506|B2|Baseline|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100812|NCT01780506|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100813|NCT01780506|P2|Participant Flow|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100814|NCT01780506|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks
100815|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100816|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100817|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100818|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100819|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100820|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100821|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100822|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100823|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100824|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100825|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100826|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100830|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100831|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100832|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100833|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100834|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100835|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100836|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100837|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100838|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100839|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100840|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100841|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100842|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100843|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100844|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100845|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100846|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
100847|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
100852|NCT01780389|P1|Participant Flow|Milnacipran|Open-label flexibly dosed milnacipran
100860|NCT01780389|O1|Outcome|Milnacipran-Open Label|"Open-label flexibly dosed milnacipran for 12 weeks. Twice-daily dosing will be used and the typical titration schedule will be as follows:
Day 1 - 12.5 mg every morning Day 2-3 - 12.5 mg twice a day Day 4-7 - 25 mg twice a day Day 8-84 - 50 mg twice a day
Taper:
Day 85-88 - 25 mg twice a day Day 89-92 - 12.5 twice a day Day 93-96 - 12.5 mg every morning"
100861|NCT01780389|E1|Reported Event|Milnacipran|Open-label flexibly dosed milnacipran
100862|NCT01780350|B1|Baseline|ResQGARD ITD|"Subjects receive a ResQGARD ITD.
ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
100863|NCT01780350|P1|Participant Flow|ResQGARD ITD|"Subjects receive a ResQGARD ITD.
ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
100864|NCT01780350|O1|Outcome|ResQGARD ITD|"Subjects receive a ResQGARD ITD.
ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
100865|NCT01780350|O1|Outcome|ResQGARD ITD|"Subjects receive a ResQGARD ITD.
ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
100866|NCT01780350|E1|Reported Event|ResQGARD ITD|"Subjects receive a ResQGARD ITD.
ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
100867|NCT01780337|B3|Baseline|Total|Total of all reporting groups
100868|NCT01780337|B2|Baseline|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Saline: Intranasal dose of saline"
100869|NCT01780337|B1|Baseline|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Oxytocin: Intranasal dose of 20 IU oxytocin"
100870|NCT01780337|P2|Participant Flow|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Saline: Intranasal dose of saline"
100871|NCT01780337|P1|Participant Flow|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Oxytocin: Intranasal dose of 20 IU oxytocin"
100872|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Saline: Intranasal dose of saline"
100873|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Oxytocin: Intranasal dose of 20 IU oxytocin"
100874|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Saline: Intranasal dose of saline"
100875|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Oxytocin: Intranasal dose of 20 IU oxytocin"
100908|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100876|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Saline: Intranasal dose of saline"
100877|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Oxytocin: Intranasal dose of 20 IU oxytocin"
100878|NCT01780337|E2|Reported Event|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Saline: Intranasal dose of saline"
100879|NCT01780337|E1|Reported Event|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.
Oxytocin: Intranasal dose of 20 IU oxytocin"
100880|NCT01780324|B3|Baseline|Total|Total of all reporting groups
100881|NCT01780324|B2|Baseline|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.
Lidocaine gel"
100882|NCT01780324|B1|Baseline|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
100883|NCT01780324|P2|Participant Flow|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.
Lidocaine gel"
100884|NCT01780324|P1|Participant Flow|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
100885|NCT01780324|O2|Outcome|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.
Lidocaine gel"
100886|NCT01780324|O1|Outcome|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
100887|NCT01780324|E2|Reported Event|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.
Lidocaine gel"
100888|NCT01780324|E1|Reported Event|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
100889|NCT01779648|B3|Baseline|Total|Total of all reporting groups
100890|NCT01779648|B2|Baseline|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100891|NCT01779648|B1|Baseline|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100892|NCT01779648|P2|Participant Flow|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
Alternate compression+Adjusted refill time"
100893|NCT01779648|P1|Participant Flow|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
Simultaneous compression +Fixed refill time:"
100894|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100895|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100896|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100897|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100898|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100899|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100900|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100901|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100902|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100903|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100904|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100905|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100906|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
101274|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
100909|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100910|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100911|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100912|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100913|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100914|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100915|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100916|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100917|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100918|NCT01779648|E2|Reported Event|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
alternate compression :"
100919|NCT01779648|E1|Reported Event|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
simultaneous compression :"
100920|NCT01779219|B3|Baseline|Total|Total of all reporting groups
100921|NCT01779219|B2|Baseline|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
100922|NCT01779219|B1|Baseline|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with was used in all procedures."
100923|NCT01779219|P2|Participant Flow|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
100924|NCT01779219|P1|Participant Flow|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) was used in all cases."
100925|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
100957|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100958|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100959|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100960|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
101275|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
100926|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
100927|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
100928|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
100929|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
100979|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100980|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
101341|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
100930|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
100931|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
100932|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
100933|NCT01779219|E2|Reported Event|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
100961|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100962|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
101362|NCT01777282|B6|Baseline|Total|Total of all reporting groups
100934|NCT01779219|E1|Reported Event|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
100935|NCT01779167|B1|Baseline|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM
Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)
Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.
Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
100936|NCT01779167|P1|Participant Flow|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM
Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)
Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.
Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
100937|NCT01779167|O1|Outcome|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM
Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)
Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.
Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
100938|NCT01779167|O1|Outcome|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM
Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)
Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.
Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
100939|NCT01779167|E1|Reported Event|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM
Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)
Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.
Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
100940|NCT01778985|B3|Baseline|Total|Total of all reporting groups
100941|NCT01778985|B2|Baseline|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100942|NCT01778985|B1|Baseline|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100943|NCT01778985|P2|Participant Flow|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100944|NCT01778985|P1|Participant Flow|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100945|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100946|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100947|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100948|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100949|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100950|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100951|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100952|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100953|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100954|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100955|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100956|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100963|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100964|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100965|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100966|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100967|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100968|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100969|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100970|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100971|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100972|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100973|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100974|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100975|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100976|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100977|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100978|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100981|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100982|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100983|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100984|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100985|NCT01778985|E2|Reported Event|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Placebo"
100986|NCT01778985|E1|Reported Event|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Premarin"
100987|NCT01778855|B3|Baseline|Total|Total of all reporting groups
100988|NCT01778855|B2|Baseline|Hypothermia|IV t-PA and hypothermia
100989|NCT01778855|B1|Baseline|Normothermia|IV t-PA and normothermia
100990|NCT01778855|P2|Participant Flow|Hypothermia|IV t-PA and hypothermia
100991|NCT01778855|P1|Participant Flow|Normothermia|IV t-PA and normothermia
100992|NCT01778855|O2|Outcome|Hypothermia|IV t-PA and hypothermia
100993|NCT01778855|O1|Outcome|Normothermia|IV t-PA and normothermia
100994|NCT01778855|E2|Reported Event|Hypothermia|IV t-PA and hypothermia
100995|NCT01778855|E1|Reported Event|Normothermia|IV t-PA and normothermia
100996|NCT01778751|B3|Baseline|Total|Total of all reporting groups
100997|NCT01778751|B2|Baseline|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.
Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
100998|NCT01778751|B1|Baseline|Control|Veterans will receive diabetes educational materials and management per their primary provider
101020|NCT01778127|B4|Baseline|Total|Total of all reporting groups
101088|NCT01778049|P2|Participant Flow|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
100999|NCT01778751|P2|Participant Flow|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.
Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
101000|NCT01778751|P1|Participant Flow|Control|Veterans will receive diabetes educational materials and management per their primary provider
101001|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.
Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
101002|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
101003|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.
Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
101004|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
101099|NCT01778049|E5|Reported Event|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
101100|NCT01778049|E4|Reported Event|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
101101|NCT01778049|E3|Reported Event|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
101005|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.
Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
101006|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
101007|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.
Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
101008|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
101009|NCT01778751|E2|Reported Event|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.
Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
101010|NCT01778751|E1|Reported Event|Control|Veterans will receive diabetes educational materials and management per their primary provider
101011|NCT01778530|B1|Baseline|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
101012|NCT01778530|P1|Participant Flow|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
101013|NCT01778530|O1|Outcome|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
101014|NCT01778530|O1|Outcome|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
101015|NCT01778530|E1|Reported Event|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
101016|NCT01778296|B1|Baseline|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
101017|NCT01778296|P1|Participant Flow|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
101018|NCT01778296|O1|Outcome|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
101019|NCT01778296|E1|Reported Event|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
101021|NCT01778127|B3|Baseline|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101022|NCT01778127|B2|Baseline|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101023|NCT01778127|B1|Baseline|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101024|NCT01778127|P3|Participant Flow|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101126|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
107466|NCT01749501|O1|Outcome|Rocorium|"0.6 mg/kg once
Rocuronium: 0.6 mg/Kg once"
101025|NCT01778127|P2|Participant Flow|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101026|NCT01778127|P1|Participant Flow|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101027|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101028|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101029|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101030|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101031|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101032|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101033|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101102|NCT01778049|E2|Reported Event|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
101127|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
101034|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101035|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101036|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101037|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101038|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101039|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101079|NCT01778062|E2|Reported Event|Placebo|Placebo
101080|NCT01778062|E1|Reported Event|Indacaterol|Indacaterol
101081|NCT01778049|B3|Baseline|Total|Total of all reporting groups
101082|NCT01778049|B2|Baseline|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
101040|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101041|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101042|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101043|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101044|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101045|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101046|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101047|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101048|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101083|NCT01778049|B1|Baseline|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
101084|NCT01778049|P6|Participant Flow|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
101049|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101050|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101051|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101052|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101053|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101054|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101055|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101056|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101057|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101085|NCT01778049|P5|Participant Flow|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
101086|NCT01778049|P4|Participant Flow|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
101087|NCT01778049|P3|Participant Flow|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
101058|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101059|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101060|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101061|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101062|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101063|NCT01778127|E3|Reported Event|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Activity Monitor: Measurement of physical activity.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101064|NCT01778127|E2|Reported Event|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101065|NCT01778127|E1|Reported Event|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Activity Monitor: Measurement of physical activity.
Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
101066|NCT01778062|B3|Baseline|Total|Total of all reporting groups
101067|NCT01778062|B2|Baseline|Placebo|Placebo once daily
101068|NCT01778062|B1|Baseline|Indacaterol|Indacaterol 150 µg once daily
101069|NCT01778062|P2|Participant Flow|Placebo|Placebo once daily
101070|NCT01778062|P1|Participant Flow|Indacaterol|Indacaterol 150 µg once daily
101071|NCT01778062|O2|Outcome|Placebo|Placebo once daily
101072|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
101073|NCT01778062|O2|Outcome|Placebo|Placebo once daily
101074|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
101075|NCT01778062|O2|Outcome|Placebo|Placebo once daily
101076|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
101077|NCT01778062|O2|Outcome|Placebo|Placebo once daily
101078|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
101089|NCT01778049|P1|Participant Flow|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
101090|NCT01778049|O4|Outcome|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
101091|NCT01778049|O3|Outcome|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
101092|NCT01778049|O2|Outcome|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
101093|NCT01778049|O1|Outcome|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
101094|NCT01778049|O4|Outcome|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
101095|NCT01778049|O3|Outcome|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
101096|NCT01778049|O2|Outcome|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
101097|NCT01778049|O1|Outcome|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
101098|NCT01778049|E6|Reported Event|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
107467|NCT01749501|O2|Outcome|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
101103|NCT01778049|E1|Reported Event|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
101104|NCT01778023|B3|Baseline|Total|Total of all reporting groups
101105|NCT01778023|B2|Baseline|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101106|NCT01778023|B1|Baseline|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101107|NCT01778023|P2|Participant Flow|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101108|NCT01778023|P1|Participant Flow|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101109|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101110|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101111|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101112|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101113|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101114|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101115|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101263|NCT01777620|E1|Reported Event|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101116|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101117|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101118|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101119|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101120|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101121|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101122|NCT01778023|E2|Reported Event|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101123|NCT01778023|E1|Reported Event|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
101124|NCT01777945|B1|Baseline|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
101125|NCT01777945|P1|Participant Flow|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
101128|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
101129|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
101130|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
101131|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
101132|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
101133|NCT01777945|E1|Reported Event|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
101134|NCT01777932|B1|Baseline|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101135|NCT01777932|P1|Participant Flow|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101136|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101137|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101138|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101139|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101218|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
101264|NCT01777581|B3|Baseline|Total|Total of all reporting groups
101140|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101141|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101142|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101143|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101144|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101145|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101146|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101147|NCT01777932|E1|Reported Event|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
101148|NCT01777776|B5|Baseline|Total|Total of all reporting groups
101296|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
101149|NCT01777776|B4|Baseline|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101150|NCT01777776|B3|Baseline|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101151|NCT01777776|B2|Baseline|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101152|NCT01777776|B1|Baseline|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101153|NCT01777776|P4|Participant Flow|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101154|NCT01777776|P3|Participant Flow|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101155|NCT01777776|P2|Participant Flow|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101156|NCT01777776|P1|Participant Flow|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101157|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
101219|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
101265|NCT01777581|B2|Baseline|Sugar Pill (Placebo)|Placebo
101158|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101159|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101160|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101161|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
101162|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101163|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101164|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101165|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
101166|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101167|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101168|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101169|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
101170|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101171|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101172|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101173|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
101174|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101175|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101176|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101177|NCT01777776|O3|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
101178|NCT01777776|O2|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101179|NCT01777776|O1|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101180|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
101181|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101182|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101183|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101184|NCT01777776|O2|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
101185|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101186|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101187|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101188|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101189|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
101190|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101191|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101192|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101193|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101194|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101195|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101196|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101197|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101198|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101199|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101200|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101201|NCT01777776|O1|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
101202|NCT01777776|O2|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101203|NCT01777776|O1|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.
LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
101204|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101297|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
101205|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101206|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101207|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101208|NCT01777776|E4|Reported Event|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101209|NCT01777776|E3|Reported Event|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101210|NCT01777776|E2|Reported Event|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101211|NCT01777776|E1|Reported Event|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.
Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
101212|NCT01777763|B3|Baseline|Total|Total of all reporting groups
101213|NCT01777763|B2|Baseline|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days.
101214|NCT01777763|B1|Baseline|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days.
101215|NCT01777763|P2|Participant Flow|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
101216|NCT01777763|P1|Participant Flow|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
101217|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
101266|NCT01777581|B1|Baseline|Milnacipran|Milnacipran, flexibly dosed 100-200 mg/day dosed twice a day
101220|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
101221|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
101222|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
101223|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
101224|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
101225|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
101226|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
101227|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
101228|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
101229|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
101230|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
101231|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
101232|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
101233|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
101234|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
101235|NCT01777763|E2|Reported Event|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
101236|NCT01777763|E1|Reported Event|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
101237|NCT01777620|B3|Baseline|Total|Total of all reporting groups
101238|NCT01777620|B2|Baseline|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101239|NCT01777620|B1|Baseline|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101240|NCT01777620|P2|Participant Flow|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101241|NCT01777620|P1|Participant Flow|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101242|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101243|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101244|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101245|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101246|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101247|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101248|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101249|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101250|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101251|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101252|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101253|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101254|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101255|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101256|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101257|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101258|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101259|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101260|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101261|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
101262|NCT01777620|E2|Reported Event|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
101276|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
101277|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
101278|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
101279|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
101280|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
101281|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
101282|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
101283|NCT01777581|E2|Reported Event|Sugar Pill (Placebo)|Placebo
101284|NCT01777581|E1|Reported Event|Milnacipran|Milnacipran, flexibly dosed
101285|NCT01777438|B3|Baseline|Total|Total of all reporting groups
101286|NCT01777438|B2|Baseline|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
101287|NCT01777438|B1|Baseline|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
101288|NCT01777438|P2|Participant Flow|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
101289|NCT01777438|P1|Participant Flow|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
101290|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
101291|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
101292|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
101293|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
101294|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
101295|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
101335|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101298|NCT01777438|E2|Reported Event|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
101299|NCT01777438|E1|Reported Event|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
101300|NCT01777425|B1|Baseline|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
101301|NCT01777425|P1|Participant Flow|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
101302|NCT01777425|O1|Outcome|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
101303|NCT01777425|O1|Outcome|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
101304|NCT01777425|O1|Outcome|Rhinosinusitis Patients and Status|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
101305|NCT01777425|E1|Reported Event|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
101306|NCT01777412|B1|Baseline|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
101307|NCT01777412|P1|Participant Flow|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
101308|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
101309|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
101310|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
101311|NCT01777412|E1|Reported Event|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
101312|NCT01777334|B3|Baseline|Total|Total of all reporting groups
101313|NCT01777334|B2|Baseline|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
101314|NCT01777334|B1|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
101315|NCT01777334|P2|Participant Flow|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
101316|NCT01777334|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
101317|NCT01777334|O2|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
101318|NCT01777334|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
101319|NCT01777334|O2|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
101320|NCT01777334|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
101321|NCT01777334|E2|Reported Event|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
101322|NCT01777334|E1|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
101323|NCT01777321|B3|Baseline|Total|Total of all reporting groups
101324|NCT01777321|B2|Baseline|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101325|NCT01777321|B1|Baseline|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101326|NCT01777321|P2|Participant Flow|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered intramuscularly (IM) on a 0,2-month schedule.
101327|NCT01777321|P1|Participant Flow|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered subcutaneously (SC) on a 0,2-month schedule.
101328|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101329|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101330|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101331|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101332|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101333|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101334|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101342|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101343|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101344|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101345|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101346|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101347|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101348|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101349|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101350|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101351|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101352|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101353|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101354|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101355|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101356|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101357|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101358|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101359|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101360|NCT01777321|E2|Reported Event|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
101361|NCT01777321|E1|Reported Event|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
101363|NCT01777282|B5|Baseline|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101364|NCT01777282|B4|Baseline|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101365|NCT01777282|B3|Baseline|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101366|NCT01777282|B2|Baseline|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101367|NCT01777282|B1|Baseline|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101368|NCT01777282|P5|Participant Flow|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101369|NCT01777282|P4|Participant Flow|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101370|NCT01777282|P3|Participant Flow|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101371|NCT01777282|P2|Participant Flow|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101372|NCT01777282|P1|Participant Flow|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101373|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101374|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101375|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101376|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101437|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101377|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101378|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101379|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101380|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101381|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101382|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101383|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101384|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101385|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101386|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101514|NCT01776645|E1|Reported Event|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
101515|NCT01776554|B3|Baseline|Total|Total of all reporting groups
101387|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101388|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101389|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101390|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101391|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101392|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101393|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101394|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101395|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101396|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101397|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101398|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101399|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101400|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101401|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101402|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101403|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101404|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101405|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101406|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101407|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101408|NCT01777282|E5|Reported Event|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101409|NCT01777282|E4|Reported Event|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101410|NCT01777282|E3|Reported Event|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101516|NCT01776554|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101411|NCT01777282|E2|Reported Event|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101412|NCT01777282|E1|Reported Event|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
101413|NCT01777269|B3|Baseline|Total|Total of all reporting groups
101414|NCT01777269|B2|Baseline|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101415|NCT01777269|B1|Baseline|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101416|NCT01777269|P2|Participant Flow|Duodart|Participants received a combination of dutasteride 0.5 milligrams (mg) and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101417|NCT01777269|P1|Participant Flow|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101418|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101419|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101420|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101421|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101422|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101423|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101424|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101425|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101426|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101427|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101428|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101429|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101430|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101431|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101432|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101433|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101434|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101435|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101436|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101438|NCT01777269|O2|Outcome|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101439|NCT01777269|O1|Outcome|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101440|NCT01777269|E2|Reported Event|Duodart|Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
101441|NCT01777269|E1|Reported Event|Placebo|Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
101442|NCT01777217|B3|Baseline|Total|Total of all reporting groups
101443|NCT01777217|B2|Baseline|Placebo|"Drug: Placebo oral
Placebo"
101444|NCT01777217|B1|Baseline|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily
Solifenacin succinate"
101445|NCT01777217|P2|Participant Flow|Placebo|"Drug: Placebo oral
Placebo"
101446|NCT01777217|P1|Participant Flow|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily
Solifenacin succinate"
101447|NCT01777217|O2|Outcome|Placebo|"Drug: Placebo oral
Placebo"
101448|NCT01777217|O1|Outcome|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily
Solifenacin succinate"
101449|NCT01777217|E2|Reported Event|Placebo|"Drug: Placebo oral
Placebo"
101450|NCT01777217|E1|Reported Event|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily
Solifenacin succinate"
101451|NCT01777191|B3|Baseline|Total|Total of all reporting groups
101452|NCT01777191|B2|Baseline|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101453|NCT01777191|B1|Baseline|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101454|NCT01777191|P2|Participant Flow|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101476|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101455|NCT01777191|P1|Participant Flow|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 milligrams (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every two weeks (Q2W) at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose every 4 weeks (Q4W).
101456|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101457|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101458|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101459|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101460|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101461|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101462|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101463|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101464|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101465|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101466|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101534|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101467|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101468|NCT01777191|O1|Outcome|80 mg Ixekizumab|Ixekizumab administered via prefilled syringe and auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101469|NCT01777191|O1|Outcome|80 mg Ixekizumab|Ixekizumab administered via prefilled syringe and auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101470|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101471|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101472|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101473|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101474|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101475|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101506|NCT01776645|B3|Baseline|Total|Total of all reporting groups
101507|NCT01776645|B2|Baseline|Significant Others Group|Significant Others of Participants with Chronic Pain
101477|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101478|NCT01777191|E4|Reported Event|Follow Up Period|All participants who received at least 1 dose of Ixekizumab entered the follow-up period.
101479|NCT01777191|E3|Reported Event|80 mg Ixe Prefilled Syringe Optional Safety Extension|One 80 mg Ixekizumab administered as an SC injection Q4W.
101480|NCT01777191|E2|Reported Event|80 mg Ixekizumab Auto-Injector Treatment Period|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101481|NCT01777191|E1|Reported Event|80 mg Ixekizumab Prefilled Syringe Treatment Period|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
101482|NCT01777126|B3|Baseline|Total|Total of all reporting groups
101483|NCT01777126|B2|Baseline|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
101484|NCT01777126|B1|Baseline|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
101485|NCT01777126|P2|Participant Flow|Oral Nutrition Protocol (ONP) Group|In this group, oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
101486|NCT01777126|P1|Participant Flow|Control Group|In the control group, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
101487|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
101488|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
101508|NCT01776645|B1|Baseline|Compassion Cultivation Training - Participants With Chronic Pa|Compassion Cultivation Training Course - Participants with Chronic Pain
101509|NCT01776645|P2|Participant Flow|Significant Others Group|Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
101510|NCT01776645|P1|Participant Flow|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
101511|NCT01776645|O1|Outcome|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
101489|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
101490|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
101491|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
101492|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
101535|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101536|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101537|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101493|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
101494|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
101495|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
101496|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
101512|NCT01776645|O1|Outcome|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
101513|NCT01776645|E2|Reported Event|Significant Others Group|Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
101497|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
101498|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
101499|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
101500|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
101501|NCT01777126|O1|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
101502|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
101503|NCT01777126|O1|Outcome|Control Group|For subjects enrolled in this arm, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
101504|NCT01777126|E2|Reported Event|Enhanced Recovery Oral Nutrition Protocol (ERONP) Group|Subjects enrolled in this arm will undergo the ERONP protocol. An enhanced oral nutrition protocol (ERONP) with restrictive instructions for parenteral nutrition is implemented. Oral intake is increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used are Fortimel Juicy® (Nutricia) 200 ml containing 300 kcal. This provides supplementary energy and essential nutrients. Supplementary fluid, approximately up to two liter, is given intravenously. If the patient is unable to produce stools on the third day post-surgery, neostigmine (Prostigmin® 0.5 mg subcutaneous, maximum 4 times a day), an acetylcholinesterase inhibitor promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel, can be administered. Only if oral intake is still insufficient after five days, PN (Oliclinomel N7) can be initiated.
101505|NCT01777126|E1|Reported Event|Control Group|Subjects enrolled in this arm will undergo usual medical and pharmaceutical care. In this group, parenteral nutrition (Oliclinomel N7) is part of the routine postoperative care program.
101517|NCT01776554|B1|Baseline|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101518|NCT01776554|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101519|NCT01776554|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101520|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101521|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101522|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101523|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101524|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101525|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101526|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101527|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101528|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101529|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101530|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101531|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101532|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101533|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101992|NCT01774981|B5|Baseline|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
101538|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101539|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101540|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101541|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101542|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101543|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101544|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101545|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101546|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101547|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101548|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101549|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101550|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101551|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101552|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101553|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
102360|NCT01772550|E3|Reported Event|20 GA BD Nexiva Diffusics - Nonrandomized|
101554|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101555|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101556|NCT01776554|E3|Reported Event|Total|Total of subjects in both high dose and low dose groups.
101557|NCT01776554|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101558|NCT01776554|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101559|NCT01776541|B3|Baseline|Total|Total of all reporting groups
101560|NCT01776541|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101561|NCT01776541|B1|Baseline|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101562|NCT01776541|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101563|NCT01776541|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101564|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101565|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101566|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101567|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101568|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101569|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101570|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101571|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101572|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101573|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101574|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101575|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101576|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101577|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
101578|NCT01776541|E3|Reported Event|Total|Total of high dose and low dose groups.
101579|NCT01776541|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101580|NCT01776541|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
101581|NCT01776268|B3|Baseline|Total|Total of all reporting groups
101582|NCT01776268|B2|Baseline|no Oral Priming|No oral priming: no intervention
101583|NCT01776268|B1|Baseline|Oral Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
101584|NCT01776268|P2|Participant Flow|no Oral Priming|
101585|NCT01776268|P1|Participant Flow|Colostrum Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
101586|NCT01776268|O2|Outcome|No Oral Priming|No oral priming
101587|NCT01776268|O1|Outcome|Oral Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
101588|NCT01776268|O2|Outcome|No Oral Priming|
101589|NCT01776268|O1|Outcome|Oral Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
101590|NCT01776268|E2|Reported Event|no Oral Priming|No oral priming: no intervention
101591|NCT01776268|E1|Reported Event|Oral Priming|Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
101592|NCT01775995|B3|Baseline|Total|Total of all reporting groups
101593|NCT01775995|B2|Baseline|Wait-list Control|Standard of Care Therapy only
101594|NCT01775995|B1|Baseline|Experimental: Meditation-CBT|"Mindfulness-CBT + Standard of Care Therapy
Mindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study."
101595|NCT01775995|P2|Participant Flow|Wait-list Control|"Usual Care
Participants receiving usual care for CLBP and opioid therapy management."
101596|NCT01775995|P1|Participant Flow|Meditation-CBT|"Meditation-CBT + Usual Care
Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management."
101597|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101598|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101599|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101600|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101601|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101602|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101603|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101604|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101605|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101606|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101607|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101608|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101609|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101610|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101611|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101612|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101613|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101614|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101615|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101616|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101617|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101746|NCT01775189|O6|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101618|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101619|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101620|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101621|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101622|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101623|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101624|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101625|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101626|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101627|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101628|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101629|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101630|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101631|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101632|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101633|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101634|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101635|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101636|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101637|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101638|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101639|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101640|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101641|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101642|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101643|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101644|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101645|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101646|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101647|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101648|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101649|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101650|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101651|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
101652|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
101653|NCT01775995|E2|Reported Event|Wait-list Control|Standard of Care Therapy only
101654|NCT01775995|E1|Reported Event|Experimental: Meditation-CBT|"Mindfulness-CBT + Standard of Care Therapy
Mindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study."
101655|NCT01775852|B3|Baseline|Total|Total of all reporting groups
101656|NCT01775852|B2|Baseline|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
101657|NCT01775852|B1|Baseline|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.
ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
101658|NCT01775852|P2|Participant Flow|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
101659|NCT01775852|P1|Participant Flow|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.
ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
101660|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
101661|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.
ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
101662|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
101686|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101663|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.
ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
101664|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
101665|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.
ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
101666|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
101667|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.
ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
101668|NCT01775852|E2|Reported Event|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
101669|NCT01775852|E1|Reported Event|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.
ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
101670|NCT01775774|B4|Baseline|Total|Total of all reporting groups
101671|NCT01775774|B3|Baseline|Mesenchymal Stem Cells 10 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101672|NCT01775774|B2|Baseline|Mesenchymal Stem Cells 5 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101673|NCT01775774|B1|Baseline|Human Mesenchymal Stem Cells 1 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101674|NCT01775774|P3|Participant Flow|Human Mesenchymal Stem Cells 10 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101675|NCT01775774|P2|Participant Flow|Human Mesenchymal Stem Cells 5 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101676|NCT01775774|P1|Participant Flow|Human Mesenchymal Stem Cells 1 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101677|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101678|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101679|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101680|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101681|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101682|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101683|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101684|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101685|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101850|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101687|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101688|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101689|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101690|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101691|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101692|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101693|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101694|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101695|NCT01775774|O3|Outcome|Human Mesenchymal Stem Cells: 10 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101696|NCT01775774|O2|Outcome|Human Mesenchymal Stem Cells: 5 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101697|NCT01775774|O1|Outcome|Human Mesenchymal Stem Cells: 1 Million Cellls/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells were administered intravenously into the 3 planned dosing cohorts.
101698|NCT01775774|E3|Reported Event|Human Mesenchymal Stem Cells: 10 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
101699|NCT01775774|E2|Reported Event|Human Mesenchymal Stem Cells: 5 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
101700|NCT01775774|E1|Reported Event|Human Mesenchymal Stem Cells: 1 Million Cells/kg PBW|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
101701|NCT01775670|B3|Baseline|Total|Total of all reporting groups
101702|NCT01775670|B2|Baseline|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101703|NCT01775670|B1|Baseline|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101704|NCT01775670|P2|Participant Flow|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the Massachusetts General Hospital (MGH) Occupational Therapists.
Occupational Therapy (OT) Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101788|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101705|NCT01775670|P1|Participant Flow|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for trapeziometacarpal (TMC) arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101706|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101707|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101708|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101709|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101710|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101711|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101712|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101713|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101714|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101715|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101716|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101717|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101718|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101719|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101720|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101721|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101722|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101723|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101724|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101725|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101726|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101727|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101728|NCT01775670|E2|Reported Event|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
101729|NCT01775670|E1|Reported Event|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint"
101730|NCT01775553|B1|Baseline|Carfilzomib|"All patients will receive Carfilzomib
Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
101731|NCT01775553|P1|Participant Flow|Carfilzomib|"All patients will receive Carfilzomib
Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
101732|NCT01775553|O1|Outcome|Carfilzomib|"All patients will receive Carfilzomib
Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
102996|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
101733|NCT01775553|O1|Outcome|Carfilzomib|"All patients will receive Carfilzomib
Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
101734|NCT01775553|O1|Outcome|Carfilzomib|"All patients will receive Carfilzomib
Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
101735|NCT01775553|O1|Outcome|Carfilzomib|"All patients will receive Carfilzomib
Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
101736|NCT01775553|O1|Outcome|Carfilzomib|"All patients will receive Carfilzomib
Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
101737|NCT01775553|E1|Reported Event|Carfilzomib|"All patients will receive Carfilzomib
Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days."
101738|NCT01775189|B1|Baseline|Entire Study Population|Included all participants enrolled in the study.
101739|NCT01775189|P7|Participant Flow|PBO SS, ALO-02 30 mg, OXY 30 mg, PBO Lac|Single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in first intervention period; followed by single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in second intervention period; then single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in third intervention period; then single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
101766|NCT01775189|O4|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101740|NCT01775189|P6|Participant Flow|OXY 30 mg, PBO SS, PBO Lac, ALO-02 30 mg|Single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in first intervention period; followed by single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in second intervention period; then single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in third intervention period; then single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
101741|NCT01775189|P5|Participant Flow|ALO-02 30 mg, PBO Lac, PBO SS, OXY 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in first intervention period; followed by single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in second intervention period; then single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in third intervention period; then single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
101742|NCT01775189|P4|Participant Flow|PBO Lac, OXY 30 mg, ALO-02 30 mg, PBO SS|Single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in first intervention period; followed by single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in second intervention period; then single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in third intervention period; then single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg capsule intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
101743|NCT01775189|P3|Participant Flow|Placebo Then Oxycodone HCl 30 mg|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on Day 1 followed by single dose of oxycodone HCl 30 mg crushed tablet intranasally on Day 2. Participants were assigned to receive ALO-02 30 mg/3.6 mg crushed capsule, placebo matched to ALO-02 30 mg/3.6 mg crushed capsule (PBO SS), oxycodone 30 mg crushed tablet (OXY 30 mg), placebo matched to oxycodone 30 mg crushed tablet (PBO Lac), intranasally, in any of the 4 sequences in the treatment phase of the study.
101744|NCT01775189|P2|Participant Flow|Oxycodone HCl 30 mg Then Placebo|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on Day 1 followed by single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on Day 2. Participants were assigned to receive oxycodone HCl 30 mg and naltrexone HCl 3.6 mg extended-release (ALO-02) 30 mg/3.6 mg crushed capsule, placebo matched to ALO-02 30 mg/3.6 mg crushed capsule (placebo sugar spheres, PBO SS), oxycodone 30 mg crushed tablet (OXY 30 mg), placebo matched to oxycodone 30 mg crushed tablet (placebo lactose tablet, PBO Lac), intranasally, in any of the 4 sequences in the treatment phase of the study.
101745|NCT01775189|P1|Participant Flow|Naloxone|Naloxone hydrochloride (HCl) 0.2 milligram (mg) intravenously followed by additional 0.6 mg naloxone hydrochloride intravenously on Day 0, each dose followed by an assessment for signs and symptoms of opioid withdrawal. Participants who did not display signs and symptoms of opioid withdrawal, were assigned to either oxycodone HCl 30 mg then placebo or placebo then oxycodone HCl 30 mg group in the drug discrimination phase of the study.
102997|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment"
101747|NCT01775189|O5|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101748|NCT01775189|O4|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101749|NCT01775189|O3|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101750|NCT01775189|O2|Outcome|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
101751|NCT01775189|O1|Outcome|Oxycodone HCl 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
101752|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101753|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101754|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101755|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101756|NCT01775189|O7|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101757|NCT01775189|O6|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101758|NCT01775189|O5|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101759|NCT01775189|O4|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101760|NCT01775189|O3|Outcome|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
101761|NCT01775189|O2|Outcome|Oxycodone HCl 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
101762|NCT01775189|O1|Outcome|Naloxone|Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase.
101763|NCT01775189|O7|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101764|NCT01775189|O6|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101765|NCT01775189|O5|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
102361|NCT01772550|E2|Reported Event|18 GA Conventional Catheter - Randomized|
101767|NCT01775189|O3|Outcome|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
101768|NCT01775189|O2|Outcome|Oxycodone HCl 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
101769|NCT01775189|O1|Outcome|Naloxone|Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase.
101770|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101771|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101772|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101773|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101774|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101775|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101776|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101777|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101778|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101779|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101780|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101781|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101782|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101783|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101784|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101785|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101786|NCT01775189|O2|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101787|NCT01775189|O1|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101789|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101790|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101791|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101792|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101793|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101794|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101795|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101796|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101797|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101798|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101799|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101800|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101801|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101802|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101803|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101804|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101805|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101806|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101807|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101808|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101809|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101810|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101811|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101812|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101813|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101814|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101815|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101816|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101817|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101818|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101819|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101820|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101821|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101822|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101823|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101824|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101825|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101826|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101827|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101828|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101829|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101830|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101831|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101832|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101833|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101834|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101835|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101836|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101837|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101838|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101839|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101840|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101841|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101842|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101843|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101844|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101845|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101846|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101847|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101848|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101849|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101851|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101852|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101853|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101854|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101855|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101856|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101857|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101858|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101859|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101860|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101861|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101862|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101863|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101864|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101865|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101866|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101867|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101868|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101869|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101870|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101871|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101872|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101873|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101874|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101875|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101876|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101877|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101878|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101879|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101880|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101881|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101882|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101883|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101884|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101885|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101886|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101887|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101888|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101889|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101890|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101891|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101892|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101893|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101894|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101895|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101896|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101897|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101898|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101899|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101900|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101901|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101902|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101903|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101904|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101905|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101906|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101907|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101908|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101909|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101910|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101911|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101912|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
107468|NCT01749501|O1|Outcome|Rocorium|"0.6 mg/kg once
Rocuronium: 0.6 mg/Kg once"
101913|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101914|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101915|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101916|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101917|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101918|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101919|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101920|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101921|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101922|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101923|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101924|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101925|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101926|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101927|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101928|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101929|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101930|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101931|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101932|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
102362|NCT01772550|E1|Reported Event|20 GA BD Nexiva Diffusics - Randomized|
101933|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101934|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101935|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101936|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101937|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101938|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101939|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101940|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101941|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101942|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101943|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101944|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101945|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101946|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101947|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101948|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101949|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101950|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101951|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101952|NCT01775189|O4|Outcome|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101953|NCT01775189|O3|Outcome|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.
101954|NCT01775189|O2|Outcome|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101955|NCT01775189|O1|Outcome|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.
101956|NCT01775189|E7|Reported Event|Oxycodone 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101957|NCT01775189|E6|Reported Event|Placebo Lactose Tablet|Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
101958|NCT01775189|E5|Reported Event|ALO-02 30 mg|Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101959|NCT01775189|E4|Reported Event|Placebo Sugar Spheres|Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.
101960|NCT01775189|E3|Reported Event|Placebo Oxycodone HCl|Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
101961|NCT01775189|E2|Reported Event|Oxycodone HCl 30 mg|Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.
101962|NCT01775189|E1|Reported Event|Naloxone|Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase.
101963|NCT01775137|B1|Baseline|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101964|NCT01775137|P1|Participant Flow|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) twice daily (bid) via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101965|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
102015|NCT01774981|O6|Outcome|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102016|NCT01774981|O5|Outcome|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102363|NCT01772537|B4|Baseline|Total|Total of all reporting groups
101966|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101967|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101968|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101969|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101970|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101971|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101972|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101990|NCT01774981|B7|Baseline|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
101991|NCT01774981|B6|Baseline|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
101973|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101974|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101975|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101976|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101977|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101978|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101979|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101980|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
102111|NCT01774604|E2|Reported Event|Placebo|"Placebo suppositories (#2)
Placebo"
101981|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101982|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) twice daily (bid) via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101983|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101984|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101985|NCT01775137|E3|Reported Event|Overall|All participants who inhaled tobramycin inhalation powder during both core and extension study.
101986|NCT01775137|E2|Reported Event|Extension|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T-326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid). The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
101987|NCT01775137|E1|Reported Event|Core|Eligible participants were assigned to four capsules of TIP at 28 mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose = 224 mg tobramycin (112 mg b.i.d.). These 56 days represented 1 cycle of therapy during core study.
101988|NCT01774981|B9|Baseline|Total|Total of all reporting groups
101989|NCT01774981|B8|Baseline|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
107469|NCT01749501|E2|Reported Event|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
101993|NCT01774981|B4|Baseline|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
101994|NCT01774981|B3|Baseline|100 mg LY3016859 (Part A)|Part A:100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
101995|NCT01774981|B2|Baseline|10 mg LY3016859 (Part A)|Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
101996|NCT01774981|B1|Baseline|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
101997|NCT01774981|P8|Participant Flow|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
101998|NCT01774981|P7|Participant Flow|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
101999|NCT01774981|P6|Participant Flow|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102000|NCT01774981|P5|Participant Flow|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102001|NCT01774981|P4|Participant Flow|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
102002|NCT01774981|P3|Participant Flow|100 mg LY3016859 (Part A)|Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
102003|NCT01774981|P2|Participant Flow|10 mg LY3016859 (Part A)|Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
102004|NCT01774981|P1|Participant Flow|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
102005|NCT01774981|O4|Outcome|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102006|NCT01774981|O3|Outcome|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102007|NCT01774981|O2|Outcome|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102008|NCT01774981|O1|Outcome|Placebo (Part B)|Part B:Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102009|NCT01774981|O4|Outcome|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102010|NCT01774981|O3|Outcome|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102011|NCT01774981|O2|Outcome|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102012|NCT01774981|O1|Outcome|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102013|NCT01774981|O8|Outcome|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102014|NCT01774981|O7|Outcome|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102364|NCT01772537|B3|Baseline|Open Repair|These patients received no intervention, just standard of care.
102017|NCT01774981|O4|Outcome|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
102018|NCT01774981|O3|Outcome|100 mg LY3016859 (Part A)|Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
102019|NCT01774981|O2|Outcome|10 mg LY3016859 (Part A)|Part A:10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
102020|NCT01774981|O1|Outcome|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
102021|NCT01774981|O4|Outcome|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102022|NCT01774981|O3|Outcome|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102023|NCT01774981|O2|Outcome|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102024|NCT01774981|O1|Outcome|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102025|NCT01774981|E8|Reported Event|750 mg LY3016859 (Part B)|Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102026|NCT01774981|E7|Reported Event|250 mg LY3016859 (Part B)|Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102027|NCT01774981|E6|Reported Event|50 mg LY3016859 (Part B)|Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102028|NCT01774981|E5|Reported Event|Placebo (Part B)|Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
102029|NCT01774981|E4|Reported Event|750 mg LY3016859 (Part A)|Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
102030|NCT01774981|E3|Reported Event|100 mg LY3016859 (Part A)|Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
102031|NCT01774981|E2|Reported Event|10 mg LY3016859 (Part A)|Part A:10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
102032|NCT01774981|E1|Reported Event|Placebo (Part A)|Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
102033|NCT01774968|B3|Baseline|Total|Total of all reporting groups
102034|NCT01774968|B2|Baseline|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102035|NCT01774968|B1|Baseline|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102036|NCT01774968|P2|Participant Flow|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.
102037|NCT01774968|P1|Participant Flow|Human Regular U-500 Insulin TID|Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.
102038|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102039|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102040|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102041|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102042|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102043|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102044|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102045|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102046|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102047|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102048|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102049|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102050|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102051|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102052|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102053|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102054|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102055|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102056|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102057|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102058|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102059|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102060|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102061|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102537|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
102062|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102063|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102064|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102065|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102066|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102067|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102068|NCT01774968|E2|Reported Event|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
102069|NCT01774968|E1|Reported Event|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
102070|NCT01774929|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
102071|NCT01774929|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
102072|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
102073|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
102074|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
102075|NCT01774929|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
102076|NCT01774903|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
102077|NCT01774903|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
102078|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
102079|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
102080|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
102081|NCT01774903|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
102082|NCT01774903|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
102083|NCT01774851|B3|Baseline|Total|Total of all reporting groups
102084|NCT01774851|B2|Baseline|Experimental Group|MM-111 + trastuzumab + paclitaxel
102085|NCT01774851|B1|Baseline|Control Group|Trastuzumab + paclitaxel
102086|NCT01774851|P2|Participant Flow|Experimental Group|MM-111 + trastuzumab + paclitaxel
102087|NCT01774851|P1|Participant Flow|Control Group|Paclitaxel + Trastuzumab
102088|NCT01774851|O2|Outcome|Experimental Group|MM-111 + trastuzumab + paclitaxel
102089|NCT01774851|O1|Outcome|Control Group|trastuzumab + paclitaxel
102090|NCT01774851|E2|Reported Event|Experimental Group|MM-111 + trastuzumab + paclitaxel
102091|NCT01774851|E1|Reported Event|Control Group|trastuzumab + paclitaxel
102092|NCT01774604|B3|Baseline|Total|Total of all reporting groups
102093|NCT01774604|B2|Baseline|Placebo|"Placebo suppositories (#2)
Placebo"
102094|NCT01774604|B1|Baseline|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1"
102095|NCT01774604|P2|Participant Flow|Placebo|"Placebo suppositories (#2)
Placebo"
102096|NCT01774604|P1|Participant Flow|Indomethacin|"Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1"
102097|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)
Placebo"
102098|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1"
102099|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)
Placebo"
102100|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1"
102101|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)
Placebo"
102102|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1"
102103|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)
Placebo"
102104|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1"
102105|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)
Placebo"
102106|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1"
102107|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)
Placebo"
102108|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1"
102109|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)
Placebo"
102110|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1"
102112|NCT01774604|E1|Reported Event|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1"
102113|NCT01774344|B3|Baseline|Total|Total of all reporting groups
102114|NCT01774344|B2|Baseline|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
102115|NCT01774344|B1|Baseline|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
102116|NCT01774344|P2|Participant Flow|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
102117|NCT01774344|P1|Participant Flow|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
102118|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
102119|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
102120|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
102121|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
102122|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
102123|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
102124|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
102125|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
102126|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
102127|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
102128|NCT01774344|E2|Reported Event|Regorafenib 160mg (BAY73-4506)|Subjects received regorafenib 160 mg (4 *40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
102129|NCT01774344|E1|Reported Event|Placebo|Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus BSC.
102130|NCT01774305|B3|Baseline|Total|Total of all reporting groups
102131|NCT01774305|B2|Baseline|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
102132|NCT01774305|B1|Baseline|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
102133|NCT01774305|P2|Participant Flow|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
102134|NCT01774305|P1|Participant Flow|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
102135|NCT01774305|O2|Outcome|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
102136|NCT01774305|O1|Outcome|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
102137|NCT01774305|O2|Outcome|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
102138|NCT01774305|O1|Outcome|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
102139|NCT01774305|E2|Reported Event|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
102140|NCT01774305|E1|Reported Event|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
102141|NCT01774253|B1|Baseline|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.
Vismodegib"
102142|NCT01774253|P1|Participant Flow|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.
Vismodegib"
102143|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.
Vismodegib"
102144|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.
Vismodegib"
102145|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.
Vismodegib"
102146|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.
Vismodegib"
102177|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102147|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.
Vismodegib"
102148|NCT01774253|E1|Reported Event|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.
Vismodegib"
102149|NCT01774149|B3|Baseline|Total|Total of all reporting groups
102150|NCT01774149|B2|Baseline|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated."
102151|NCT01774149|B1|Baseline|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated."
102152|NCT01774149|P2|Participant Flow|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated."
102153|NCT01774149|P1|Participant Flow|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated."
102154|NCT01774149|O2|Outcome|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated."
102155|NCT01774149|O1|Outcome|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated."
102156|NCT01774149|O2|Outcome|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated."
102157|NCT01774149|O1|Outcome|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated."
102158|NCT01774149|E2|Reported Event|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated."
107470|NCT01749501|E1|Reported Event|Rocorium|"0.6 mg/kg once
Rocuronium: 0.6 mg/Kg once"
102159|NCT01774149|E1|Reported Event|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated."
102160|NCT01774110|B1|Baseline|Early Standardized Task Training|"Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.
Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset."
102161|NCT01774110|P1|Participant Flow|Early Standardized Task Training|"Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.
Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset."
102162|NCT01774110|O1|Outcome|Early Standardized Treadmill Training|
102163|NCT01774110|O1|Outcome|Early Standardized Treadmill Training|
102164|NCT01774110|O1|Outcome|ESTT|
102165|NCT01774110|E1|Reported Event|ESTT|early standardized treadmill training
102166|NCT01774097|B3|Baseline|Total|Total of all reporting groups
102167|NCT01774097|B2|Baseline|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102168|NCT01774097|B1|Baseline|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102169|NCT01774097|P2|Participant Flow|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102170|NCT01774097|P1|Participant Flow|ALDHbr|"Participants will receive ALDHbr via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh"
102171|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102172|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102173|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102174|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102175|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102176|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102178|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102179|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102180|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102181|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102182|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102183|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102184|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102185|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102186|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102187|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102188|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102189|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102190|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh"
102191|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102192|NCT01774097|O1|Outcome|ALDHbr|Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh
102193|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102194|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102195|NCT01774097|E2|Reported Event|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection
Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
102196|NCT01774097|E1|Reported Event|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection
ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
102197|NCT01774084|B3|Baseline|Total|Total of all reporting groups
102198|NCT01774084|B2|Baseline|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
102199|NCT01774084|B1|Baseline|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
102200|NCT01774084|P2|Participant Flow|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
102201|NCT01774084|P1|Participant Flow|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
102202|NCT01774084|O2|Outcome|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
102203|NCT01774084|O1|Outcome|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
102204|NCT01774084|O2|Outcome|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
102205|NCT01774084|O1|Outcome|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
102206|NCT01774084|E2|Reported Event|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
102207|NCT01774084|E1|Reported Event|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
102208|NCT01774045|B3|Baseline|Total|Total of all reporting groups
102209|NCT01774045|B2|Baseline|Placebo Control|"Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.
Placebo"
102210|NCT01774045|B1|Baseline|PDC-1421|"Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.
PDC-1421"
102251|NCT01773291|B3|Baseline|Control Group|"laser acupuncture without laser output in control group.
control: sham laser acupuncture"
102211|NCT01774045|P2|Participant Flow|Placebo Control|"Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.
Placebo"
102212|NCT01774045|P1|Participant Flow|PDC-1421|"Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.
PDC-1421"
102213|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours.
102214|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
102215|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
102216|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
102217|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
102218|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
102219|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
102220|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
102221|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours.
102222|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
102223|NCT01774045|E2|Reported Event|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
102224|NCT01774045|E1|Reported Event|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
107497|NCT01748916|O1|Outcome|Beta-Carotene Absorption From Papaya|
102225|NCT01773889|B1|Baseline|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
102226|NCT01773889|P1|Participant Flow|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
102227|NCT01773889|O1|Outcome|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
102228|NCT01773889|E1|Reported Event|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
102229|NCT01773473|B3|Baseline|Total|Total of all reporting groups
102230|NCT01773473|B2|Baseline|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
102231|NCT01773473|B1|Baseline|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
102232|NCT01773473|P2|Participant Flow|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
102233|NCT01773473|P1|Participant Flow|Insulin Lispro Mix25|Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
102234|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
102235|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
102236|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
102237|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
102238|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
102239|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
102240|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
102241|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
102242|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
102243|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
102244|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
102245|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
102246|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
102247|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
102248|NCT01773473|E2|Reported Event|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
102249|NCT01773473|E1|Reported Event|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
102250|NCT01773291|B4|Baseline|Total|Total of all reporting groups
102252|NCT01773291|B2|Baseline|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points
laser acupuncture: laser acupuncture on GV26 and 12 Well points"
102253|NCT01773291|B1|Baseline|Acupuncture|"acupuncture on GV26 and 12 Well points
acupuncture: acupuncture on GV26 and 12 Well points"
102254|NCT01773291|P3|Participant Flow|Control Group|"laser acupuncture without laser output in control group.
control: sham laser acupuncture on GV26 and 12 Well points"
102255|NCT01773291|P2|Participant Flow|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points
laser acupuncture: laser acupuncture on GV26 and 12 Well points"
102256|NCT01773291|P1|Participant Flow|Acupuncture|"acupuncture on Shuigou (GV26) and 12 Well points
acupuncture: acupuncture on GV26 and 12 Well points"
102257|NCT01773291|O3|Outcome|Control Group|"laser acupuncture without laser output in control group.
control: sham laser acupuncture"
102258|NCT01773291|O2|Outcome|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points
laser acupuncture: laser acupuncture on GV26 and 12 Well points"
102259|NCT01773291|O1|Outcome|Acupuncture|"acupuncture on GV26 and 12 Well points
acupuncture: acupuncture on GV26 and 12 Well points"
102260|NCT01773291|O3|Outcome|Control Group|"laser acupuncture without laser output in control group.
control: sham laser acupuncture on GV26 and 12 Well points"
102261|NCT01773291|O2|Outcome|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points
laser acupuncture: laser acupuncture on GV26 and 12 Well points"
102262|NCT01773291|O1|Outcome|Acupuncture|"acupuncture on GV26 and 12 Well points
acupuncture: acupuncture on GV26 and 12 Well points"
102263|NCT01773291|E3|Reported Event|Control Group|"laser acupuncture without laser output in control group.
control: sham laser acupuncture on GV26 and 12 Well points"
102264|NCT01773291|E2|Reported Event|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points
laser acupuncture: laser acupuncture on GV26 and 12 Well points"
102265|NCT01773291|E1|Reported Event|Acupuncture|"acupuncture on GV26 and 12 Well points
acupuncture: acupuncture on GV26 and 12 Well points"
102266|NCT01773226|B1|Baseline|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.
Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
102267|NCT01773226|P1|Participant Flow|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.
Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
102268|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.
Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
102288|NCT01773122|P2|Participant Flow|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102269|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.
Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
102270|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.
Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
102271|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.
Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
102272|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.
Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
102273|NCT01773226|E1|Reported Event|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.
Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
102274|NCT01773135|B3|Baseline|Total|Total of all reporting groups
102275|NCT01773135|B2|Baseline|Full Term Group|"pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.
investigators obtained a blood sample from all patient to measure the serum level of ACTH.
all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.
this group delivered full term (after 37 weeks of gestation)"
102276|NCT01773135|B1|Baseline|Preterm Group|"pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.
investigators obtained a blood sample from all patient to measure the serum level of ACTH.
all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.
this group delivered preterm (before 37 weeks of gestation)"
102306|NCT01772654|P1|Participant Flow|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence
Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.
This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
102307|NCT01772654|O2|Outcome|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence
Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood. This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
102277|NCT01773135|P1|Participant Flow|Pregnant Women With Threatened Preterm Labor|"pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.
then, collection of blood sample and tocolysis adminstration will be done
investigators obtained a blood sample from all patient to measure the serum level of ACTH.
all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.
After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone."
102278|NCT01773135|O2|Outcome|Full Term Group|group of patients who delivered after 37 weeks of gestation
102279|NCT01773135|O1|Outcome|Preterm Group|group of patients who delivered before 37 weeks of gestation
102280|NCT01773135|E1|Reported Event|Pregnant Women With Threatened Preterm Labor|"pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.
then, collection of blood sample and tocolysis adminstration will be done
investigators obtained a blood sample from all patient to measure the serum level of ACTH.
all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.
After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone."
102281|NCT01773122|B5|Baseline|Total|Total of all reporting groups
102282|NCT01773122|B4|Baseline|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
102283|NCT01773122|B3|Baseline|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102284|NCT01773122|B2|Baseline|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102285|NCT01773122|B1|Baseline|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102286|NCT01773122|P4|Participant Flow|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
102287|NCT01773122|P3|Participant Flow|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102289|NCT01773122|P1|Participant Flow|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102290|NCT01773122|O4|Outcome|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
102291|NCT01773122|O3|Outcome|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102292|NCT01773122|O2|Outcome|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102293|NCT01773122|O1|Outcome|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102294|NCT01773122|O4|Outcome|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
102295|NCT01773122|O3|Outcome|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102296|NCT01773122|O2|Outcome|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102297|NCT01773122|O1|Outcome|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102298|NCT01773122|E4|Reported Event|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
102299|NCT01773122|E3|Reported Event|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102300|NCT01773122|E2|Reported Event|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102301|NCT01773122|E1|Reported Event|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
102302|NCT01772654|B3|Baseline|Total|Total of all reporting groups
102303|NCT01772654|B2|Baseline|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence
Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.
This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
102304|NCT01772654|B1|Baseline|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence
Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.
This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
102305|NCT01772654|P2|Participant Flow|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence
Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.
This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
102346|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
102347|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
102308|NCT01772654|O1|Outcome|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence
Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.
This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
102309|NCT01772654|E2|Reported Event|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence
Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.
This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
102310|NCT01772654|E1|Reported Event|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence
Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.
This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
102311|NCT01772576|B1|Baseline|Reliance 4-Front|"Single arm, all patients will be implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation should be from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
102312|NCT01772576|P1|Participant Flow|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
102313|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
102314|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
102315|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
102316|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
102501|NCT01771965|B1|Baseline|Usual Care|No intervention.
102317|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
102318|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
102319|NCT01772576|E1|Reported Event|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
102320|NCT01772550|B4|Baseline|Total|Total of all reporting groups
102321|NCT01772550|B3|Baseline|20 GA BD Nexiva Diffusics - Nonrandomized|
102322|NCT01772550|B2|Baseline|18 GA Conventional Catheter - Randomized|
102323|NCT01772550|B1|Baseline|20 GA BD Nexiva Diffusics - Randomized|
102324|NCT01772550|P3|Participant Flow|20 GA BD Nexiva Diffusics - Nonrandomized|Subjects whose veins are not suitable for an 18GA IV catheter will be assigned to this non-randomized arm. During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20GA fenestrated BD Nexiva Diffusics single port IV catheter
102325|NCT01772550|P2|Participant Flow|18 GA Conventional Catheter - Randomized|During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the non-fenestrated 18GA x 1.25 inch Smiths Medical Jelco IV catheter
102326|NCT01772550|P1|Participant Flow|20 GA BD Nexiva Diffusics - Randomized|During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20 GA fenestrated BD Nexiva Diffusics single port IV catheter
102327|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
102328|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
102329|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
102330|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
102331|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
102332|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
102333|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
102334|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
102335|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
102336|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
102337|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
102338|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
102339|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
102340|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
102341|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
102342|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
102343|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
102344|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
102345|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
102365|NCT01772537|B2|Baseline|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.
isoflurane"
102366|NCT01772537|B1|Baseline|Stent Graft Repair Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.
Propofol: Intravenous anesthetic"
102367|NCT01772537|P3|Participant Flow|Open Repair|These patient will receive no intervention, just standard of care.
102368|NCT01772537|P2|Participant Flow|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.
isoflurane"
102369|NCT01772537|P1|Participant Flow|Stent Graft Repair Propofol|"Patients have a stent graft repair receiving intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.
Propofol: Intravenous anesthetic"
102370|NCT01772537|O2|Outcome|Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.
isoflurane"
102371|NCT01772537|O1|Outcome|Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.
Propofol: Intravenous anesthetic"
102372|NCT01772537|O3|Outcome|Stent Graft Aneurysm Repair Isoflurane|These are participants that received stenting of thoracoabdominal aneurysms instead of an open repair and received Isoflurane as their primary anesthetic.
102373|NCT01772537|O2|Outcome|Delerium Staus Post Stenting of Aneuryms Propofol|These are participants that received stenting of thoracoabdominal aneurysms instead of an open repair and received Propofol as their primary anesthetic.
102374|NCT01772537|O1|Outcome|Delirum Status Post Open Thoracoabdominal Aneurysm Repair|These are participants that received open thoracoabdominal aneurysm repair instead of aneurysm stenting.
102375|NCT01772537|O2|Outcome|Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.
isoflurane"
102376|NCT01772537|O1|Outcome|Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.
Propofol: Intravenous anesthetic"
102377|NCT01772537|O2|Outcome|Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.
isoflurane"
102378|NCT01772537|O1|Outcome|Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.
Propofol: Intravenous anesthetic"
102379|NCT01772537|E3|Reported Event|Open Thoracoabdominal Aneurysm Repair|These are patients that received open thoracabdominal aneurysm repair instead of aneurysm stenting.
102380|NCT01772537|E2|Reported Event|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.
isoflurane"
107498|NCT01748916|E1|Reported Event|All Groups|All groups in study
102381|NCT01772537|E1|Reported Event|Stent Graft Repair Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.
Propofol: Intravenous anesthetic"
102382|NCT01772368|B1|Baseline|All Participants|All subjects, regardless of the order of treatments to which they were randomized in this cross-over study.
102383|NCT01772368|P1|Participant Flow|All Participants|All subjects, regardless of the order of treatments to which they were randomized in this cross-over study.
102384|NCT01772368|O7|Outcome|Fp MDPI 50 mcg X 2 BID|Patients used 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the 'washout' between treatment periods, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.
102385|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
102386|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
102387|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
102388|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
102389|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
102390|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
102391|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
102392|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
102393|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
102394|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
102395|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
102396|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
102397|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
102398|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
102399|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
102400|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
102401|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
102402|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
102403|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
102404|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
102405|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
102406|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
102407|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
102408|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
102409|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
102410|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
102411|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
102412|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
102413|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
102414|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
102415|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
102416|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
102417|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
102418|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
102419|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
102420|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
102571|NCT01770743|B3|Baseline|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102421|NCT01772368|E7|Reported Event|Fp MDPI 50 mcg X 2 BID|Patients used 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the 'washout' between treatment periods, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.
102422|NCT01772368|E6|Reported Event|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
102423|NCT01772368|E5|Reported Event|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
102424|NCT01772368|E4|Reported Event|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
102425|NCT01772368|E3|Reported Event|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
102426|NCT01772368|E2|Reported Event|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
102427|NCT01772368|E1|Reported Event|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
102428|NCT01772316|B1|Baseline|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102429|NCT01772316|P1|Participant Flow|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 milligram (mg) given as 0.9 milliliter (mL) of a 180 milligram per milliliter (mg/mL) solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by subcutaneous (SC) injection and as a single fixed dose irrespective of body weight.
102430|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102431|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102432|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102433|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102434|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102435|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102436|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102437|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102438|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102439|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102440|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102441|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102442|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102443|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102444|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102445|NCT01772316|E1|Reported Event|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
102446|NCT01772147|B4|Baseline|Total|Total of all reporting groups
102447|NCT01772147|B3|Baseline|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102448|NCT01772147|B2|Baseline|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102449|NCT01772147|B1|Baseline|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102450|NCT01772147|P3|Participant Flow|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102451|NCT01772147|P2|Participant Flow|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received umeclidinium bromide (UMEC) 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102452|NCT01772147|P1|Participant Flow|Placebo QD + FSC 250/50 µg BID|Participants received placebo once daily (QD) each morning via a dry powder inhaler (DPI) and FSC 250/50 µg twice daily (BID) (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102453|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102454|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102455|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102456|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102457|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102458|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102459|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102460|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102461|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102462|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102463|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102464|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102465|NCT01772147|E3|Reported Event|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102466|NCT01772147|E2|Reported Event|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102467|NCT01772147|E1|Reported Event|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102468|NCT01772134|B4|Baseline|Total|Total of all reporting groups
102469|NCT01772134|B3|Baseline|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102470|NCT01772134|B2|Baseline|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102471|NCT01772134|B1|Baseline|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102472|NCT01772134|P3|Participant Flow|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102473|NCT01772134|P2|Participant Flow|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received umeclidinium bromide (UMEC) 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102474|NCT01772134|P1|Participant Flow|Placebo QD + FSC 250/50 µg BID|Participants received placebo once daily (QD) each morning via a dry powder inhaler (DPI) and fluticasone propionate and salmeterol (FSC) 250/50 micrograms (µg) twice daily (BID) (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102475|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102476|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102477|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102478|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102479|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102480|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102481|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102482|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102483|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102484|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102485|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102486|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102487|NCT01772134|E3|Reported Event|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102488|NCT01772134|E2|Reported Event|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102489|NCT01772134|E1|Reported Event|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
102490|NCT01771991|B3|Baseline|Total|Total of all reporting groups
102491|NCT01771991|B2|Baseline|Placebo Group|"Cetaphil cream
Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
102538|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
102539|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
102540|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
102492|NCT01771991|B1|Baseline|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)
Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
102493|NCT01771991|P2|Participant Flow|Placebo Group|"Cetaphil cream
Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
102494|NCT01771991|P1|Participant Flow|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)
Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
102495|NCT01771991|O2|Outcome|Placebo Group|"Cetaphil cream
Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
102496|NCT01771991|O1|Outcome|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)
Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
102497|NCT01771991|E2|Reported Event|Placebo Group|"Cetaphil cream
Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
102498|NCT01771991|E1|Reported Event|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)
Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
102499|NCT01771965|B3|Baseline|Total|Total of all reporting groups
102500|NCT01771965|B2|Baseline|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone
CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
102502|NCT01771965|P2|Participant Flow|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone
CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
102503|NCT01771965|P1|Participant Flow|Usual Care|No intervention.
102504|NCT01771965|O2|Outcome|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone
CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
102505|NCT01771965|O1|Outcome|Usual Care|No intervention.
102506|NCT01771965|E2|Reported Event|CB Intervention|"Cognitive Behavioral one-on-one single session administered by phone
CB Intervention: The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior."
102507|NCT01771965|E1|Reported Event|Usual Care|No intervention.
102508|NCT01771913|B3|Baseline|Total|Total of all reporting groups
102509|NCT01771913|B2|Baseline|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement
ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
102510|NCT01771913|B1|Baseline|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
102541|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
102511|NCT01771913|P2|Participant Flow|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement
ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
102512|NCT01771913|P1|Participant Flow|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
102513|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement
ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
102514|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
102515|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement
ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
102516|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
102609|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102517|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement
ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
102518|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
102519|NCT01771913|E2|Reported Event|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement
ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
102520|NCT01771913|E1|Reported Event|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
102521|NCT01771172|B1|Baseline|Acute Defibrillation Testing|
102522|NCT01771172|P1|Participant Flow|Acute Defibrillation Testing|
102523|NCT01771172|O1|Outcome|Acute Defibrillation Testing|
102524|NCT01771172|E1|Reported Event|Acute Defibrillation Testing|
102525|NCT01770860|B1|Baseline|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
102526|NCT01770860|P1|Participant Flow|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
102527|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
102528|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
102529|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
102530|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
102531|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
102532|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
102533|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
102534|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
102535|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
102536|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
102543|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
102544|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
102545|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
102546|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
102547|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
102548|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
102549|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
102550|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
102551|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
102552|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
102553|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
102554|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
102555|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
102556|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
102557|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
102558|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
102559|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
102560|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
102561|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
102562|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
102563|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
102564|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
102565|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
102566|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
102567|NCT01770860|E1|Reported Event|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
102568|NCT01770743|B6|Baseline|Total|Total of all reporting groups
102569|NCT01770743|B5|Baseline|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102570|NCT01770743|B4|Baseline|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102572|NCT01770743|B2|Baseline|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102573|NCT01770743|B1|Baseline|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102574|NCT01770743|P5|Participant Flow|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102575|NCT01770743|P4|Participant Flow|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102576|NCT01770743|P3|Participant Flow|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102577|NCT01770743|P2|Participant Flow|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102578|NCT01770743|P1|Participant Flow|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102579|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102580|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102581|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102582|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102583|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102584|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102585|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102586|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102587|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102588|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102589|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102590|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102591|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102974|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102592|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102593|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102594|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102595|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102596|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102597|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102598|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102599|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102600|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102601|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102602|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102603|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102604|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102605|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102606|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102607|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102608|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102610|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102611|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102612|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102613|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102614|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102615|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102616|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102617|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102618|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102619|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102620|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102621|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102622|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102623|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102624|NCT01770743|E5|Reported Event|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax"
102625|NCT01770743|E4|Reported Event|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102626|NCT01770743|E3|Reported Event|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102627|NCT01770743|E2|Reported Event|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102628|NCT01770743|E1|Reported Event|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
102876|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102629|NCT01770691|B1|Baseline|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary.
TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
102630|NCT01770691|P1|Participant Flow|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. Not all subjects will use all SMD'S
TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
102631|NCT01770691|O4|Outcome|Cleared TIPI Device (G3)|7 subjects used the cleared TIPI G3 for up to 8 hours
102632|NCT01770691|O3|Outcome|SMD 9|7 subjects used SMD 9 for up to 8 hours
102633|NCT01770691|O2|Outcome|SMD 12 2009|6 subjects used SMD 12 for up to 8 hours during 2009
102634|NCT01770691|O1|Outcome|SMD 12 2008|5 subjects used SMD 12 for up to 8 hours during 2008
102635|NCT01770691|E1|Reported Event|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary.
TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
102636|NCT01770652|B5|Baseline|Total|Total of all reporting groups
102637|NCT01770652|B4|Baseline|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102638|NCT01770652|B3|Baseline|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102639|NCT01770652|B2|Baseline|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102640|NCT01770652|B1|Baseline|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102641|NCT01770652|P4|Participant Flow|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102642|NCT01770652|P3|Participant Flow|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102732|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
102643|NCT01770652|P2|Participant Flow|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102644|NCT01770652|P1|Participant Flow|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102645|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102646|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102647|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102648|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102649|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102650|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102651|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102652|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102653|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102654|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102655|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102656|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102657|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102658|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102659|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102660|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102661|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102662|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102663|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102664|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102665|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102666|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102667|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102668|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Deferiprone: Oral iron chelator"
102669|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102670|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102671|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102672|NCT01770652|O1|Outcome|Normal Renal Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102673|NCT01770652|E4|Reported Event|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102674|NCT01770652|E3|Reported Event|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102675|NCT01770652|E2|Reported Event|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102676|NCT01770652|E1|Reported Event|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone"
102677|NCT01770509|B3|Baseline|Total|Total of all reporting groups
102678|NCT01770509|B2|Baseline|Application of NMBM|"Daily application of NMBM
NMBM: Daily application of NMBM in addition to compression therapy
Compression garments: Compression garments"
102679|NCT01770509|B1|Baseline|Standard of Care|"Standard of care: Dressings +Compression garments
Compression garments: Compression garments"
102680|NCT01770509|P2|Participant Flow|Application of NMBM|"Daily application of NMBM
NMBM: Daily application of NMBM in addition to compression therapy
Compression garments: Compression garments"
102681|NCT01770509|P1|Participant Flow|Standard of Care|"Standard of care: Dressings +Compression garments
Compression garments: Compression garments"
102682|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM
NMBM: Daily application of NMBM in addition to compression therapy
Compression garments: Compression garments"
102683|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments
Compression garments: Compression garments"
102684|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM
NMBM: Daily application of NMBM in addition to compression therapy
Compression garments: Compression garments"
102685|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments
Compression garments: Compression garments"
102686|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM
NMBM: Daily application of NMBM in addition to compression therapy
Compression garments: Compression garments"
102687|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments
Compression garments: Compression garments"
102688|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM
NMBM: Daily application of NMBM in addition to compression therapy
Compression garments: Compression garments"
102689|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments
Compression garments: Compression garments"
102690|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM
NMBM: Daily application of NMBM in addition to compression therapy
Compression garments: Compression garments"
102691|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments
Compression garments: Compression garments"
102692|NCT01770509|E2|Reported Event|Application of NMBM|"Daily application of NMBM
NMBM: Daily application of NMBM in addition to compression therapy
Compression garments: Compression garments"
102693|NCT01770509|E1|Reported Event|Standard of Care|"Standard of care: Dressings +Compression garments
Compression garments: Compression garments"
102694|NCT01770483|B3|Baseline|Total|Total of all reporting groups
102695|NCT01770483|B2|Baseline|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months
Ribavirin : ribazole
nitazoxanide : nitazoxanide 500mg twice daily
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
102696|NCT01770483|B1|Baseline|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
Ribavirin : ribazole
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
102697|NCT01770483|P2|Participant Flow|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months
Ribavirin : ribazole
nitazoxanide : nitazoxanide 500mg twice daily
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
102698|NCT01770483|P1|Participant Flow|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
Ribavirin : ribazole
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
102699|NCT01770483|O2|Outcome|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months
Ribavirin : ribazole
nitazoxanide : nitazoxanide 500mg twice daily
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
102700|NCT01770483|O1|Outcome|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
Ribavirin : ribazole
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
102701|NCT01770483|O2|Outcome|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months
Ribavirin : ribazole
nitazoxanide : nitazoxanide 500mg twice daily
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
102995|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
102702|NCT01770483|O1|Outcome|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
Ribavirin : ribazole
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
102703|NCT01770483|E2|Reported Event|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months
Ribavirin : ribazole
nitazoxanide : nitazoxanide 500mg twice daily
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
102704|NCT01770483|E1|Reported Event|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
Ribavirin : ribazole
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
102705|NCT01770392|B1|Baseline|Overall Study|This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
102706|NCT01770392|P1|Participant Flow|Overall Study|This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
102707|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
102708|NCT01770392|O1|Outcome|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
102709|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg Rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
102710|NCT01770392|O1|Outcome|Nintedanib|150 mg of Nintedanib was given as a single dose on Day 1.
102711|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
102712|NCT01770392|O1|Outcome|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
102713|NCT01770392|E4|Reported Event|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
102714|NCT01770392|E3|Reported Event|Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1
102715|NCT01770392|E2|Reported Event|Washout Period|washout period of at least 14 days between the administrations of nintedanib. During this period no trial drug was administered
102716|NCT01770392|E1|Reported Event|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
102717|NCT01770379|B4|Baseline|Total|Total of all reporting groups
102718|NCT01770379|B3|Baseline|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
102719|NCT01770379|B2|Baseline|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
102720|NCT01770379|B1|Baseline|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
105534|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily
ponatinib"
102721|NCT01770379|P3|Participant Flow|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
102722|NCT01770379|P2|Participant Flow|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
102723|NCT01770379|P1|Participant Flow|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
102724|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
102725|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
102726|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
102727|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
102728|NCT01770379|O2|Outcome|AIN457 150 mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
102729|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status
102730|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
102731|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
102733|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
102734|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
102735|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
102736|NCT01770379|E3|Reported Event|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
102737|NCT01770379|E2|Reported Event|Any AIN457 150 mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
102738|NCT01770379|E1|Reported Event|Any AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
102739|NCT01770366|B3|Baseline|Total|Total of all reporting groups
102740|NCT01770366|B2|Baseline|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.
Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
102741|NCT01770366|B1|Baseline|Usual Care|"Patients will receive usual care from the post-surgical clinic team.
Usual Care"
102742|NCT01770366|P2|Participant Flow|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.
Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
102743|NCT01770366|P1|Participant Flow|Usual Care|"Patients will receive usual care from the post-surgical clinic team.
Usual Care"
102744|NCT01770366|O2|Outcome|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.
Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
102745|NCT01770366|O1|Outcome|Usual Care|"Patients will receive usual care from the post-surgical clinic team.
Usual Care"
102746|NCT01770366|E2|Reported Event|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.
Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
102747|NCT01770366|E1|Reported Event|Usual Care|"Patients will receive usual care from the post-surgical clinic team.
Usual Care"
102748|NCT01770314|B3|Baseline|Total|Total of all reporting groups
102749|NCT01770314|B2|Baseline|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
102750|NCT01770314|B1|Baseline|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
102751|NCT01770314|P2|Participant Flow|Experimental|Participants were given instructions via email to review eleven online lessons about opioid medication safety. Instructions suggested that participants view one lesson per day for eleven consecutive days. Each educational lesson focused on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
102752|NCT01770314|P1|Participant Flow|Control|The control group was a waitlist control. Participants were given access to the experimental intervention program after the intervention period and follow up assessments were completed.
102753|NCT01770314|O2|Outcome|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
102754|NCT01770314|O1|Outcome|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
102755|NCT01770314|O2|Outcome|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
102756|NCT01770314|O1|Outcome|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
102757|NCT01770314|E2|Reported Event|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
102758|NCT01770314|E1|Reported Event|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
102759|NCT01770145|B1|Baseline|APOKYN|"Subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
102760|NCT01770145|P1|Participant Flow|APOKYN|"Subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatmetn Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
102761|NCT01770145|O1|Outcome|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatmet Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
102762|NCT01770145|O1|Outcome|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
102877|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102763|NCT01770145|E1|Reported Event|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatmetn Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
102764|NCT01769612|B1|Baseline|CL Detect Rapid Test and Microsopy Samples|"Samples taken to be evaluated in the CL Detect and Microscopy assays
No Intervention"
102765|NCT01769612|P1|Participant Flow|CL Detect Rapid Test and Microsopy Samples|"Samples taken to be evaluated in the CL Detect and Microscopy assays
No Intervention"
102766|NCT01769612|O3|Outcome|Culture|Data for Culture results
102767|NCT01769612|O2|Outcome|Microscopy|Data for Micrscopy
102768|NCT01769612|O1|Outcome|CL Detect Rapid Test|Data for CL Detect Rapid Test
102769|NCT01769612|E1|Reported Event|CL Detect Rapid Test and Microsopy Samples|"Samples taken to be evaluated in the CL Detect and Microscopy assays
No Intervention"
102770|NCT01769586|B3|Baseline|Total|Total of all reporting groups
102771|NCT01769586|B2|Baseline|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)
Midazolam"
102772|NCT01769586|B1|Baseline|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)
Diphenhydramine"
102773|NCT01769586|P2|Participant Flow|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)
Midazolam"
102774|NCT01769586|P1|Participant Flow|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)
Diphenhydramine"
102775|NCT01769586|O2|Outcome|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)
Midazolam"
102776|NCT01769586|O1|Outcome|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)
Diphenhydramine"
102777|NCT01769586|E2|Reported Event|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)
Midazolam"
102778|NCT01769586|E1|Reported Event|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)
Diphenhydramine"
102779|NCT01769508|B1|Baseline|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery
5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.
Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
102780|NCT01769508|P1|Participant Flow|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery
5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.
Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
102781|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery
5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.
Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
102782|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery
5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.
Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
102783|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery
5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.
Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
102784|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery
5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.
Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
102785|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery
5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.
Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
102786|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery
5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.
Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
102787|NCT01769508|E1|Reported Event|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery
5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.
Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
102788|NCT01769443|B3|Baseline|Total|Total of all reporting groups
102840|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
102841|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
102970|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102789|NCT01769443|B2|Baseline|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102790|NCT01769443|B1|Baseline|No Desensitization|No desensitization therapy pre-transplantation
102791|NCT01769443|P2|Participant Flow|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102792|NCT01769443|P1|Participant Flow|No Desensitization|No desensitization therapy pre-transplantation
102793|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102794|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102850|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle."
102795|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102796|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102797|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102798|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102799|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102800|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102801|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102802|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102803|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102804|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
105535|NCT01761747|E1|Reported Event|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily
ponatinib"
102805|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102806|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102807|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102808|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102809|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102810|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102811|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102812|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102813|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102814|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102815|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102816|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102817|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102818|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102819|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102820|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102971|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102821|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102822|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102823|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102824|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102825|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102826|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102827|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102828|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102829|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102830|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
102831|NCT01769443|E2|Reported Event|Desensitization|"Plasmapheresis with concomitant bortezomib.
Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
102832|NCT01769443|E1|Reported Event|No Desensitization|No desensitization therapy pre-transplantation
102833|NCT01769391|B3|Baseline|Total|Total of all reporting groups
102834|NCT01769391|B2|Baseline|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
102835|NCT01769391|B1|Baseline|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m^2) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
102836|NCT01769391|P2|Participant Flow|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
102837|NCT01769391|P1|Participant Flow|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
102838|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
102839|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
102842|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
102843|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
102844|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
102845|NCT01769391|O1|Outcome|Necitumumab + Paclitaxel+ Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
102846|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles."
102847|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
102848|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle."
102849|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
102851|NCT01769391|E2|Reported Event|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
102852|NCT01769391|E1|Reported Event|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles."
102853|NCT01769378|B3|Baseline|Total|Total of all reporting groups
102854|NCT01769378|B2|Baseline|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102855|NCT01769378|B1|Baseline|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102856|NCT01769378|P2|Participant Flow|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102857|NCT01769378|P1|Participant Flow|Dulaglutide|Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102858|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102859|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102860|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102861|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102862|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102863|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102864|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102865|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102866|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102867|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102868|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102869|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102870|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102871|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102872|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102873|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102874|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102875|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102878|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102879|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102880|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102881|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102882|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102883|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102884|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102885|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102886|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102887|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102888|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102889|NCT01769378|E2|Reported Event|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102890|NCT01769378|E1|Reported Event|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
102891|NCT01769365|B4|Baseline|Total|Total of all reporting groups
102892|NCT01769365|B3|Baseline|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
102893|NCT01769365|B2|Baseline|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
102943|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1
Ipilimumab: Given intratumorally"
102894|NCT01769365|B1|Baseline|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
102895|NCT01769365|P3|Participant Flow|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
102896|NCT01769365|P2|Participant Flow|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
102897|NCT01769365|P1|Participant Flow|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
102898|NCT01769365|O3|Outcome|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
102899|NCT01769365|O2|Outcome|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
102900|NCT01769365|O1|Outcome|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
102901|NCT01769365|E3|Reported Event|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
102902|NCT01769365|E2|Reported Event|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
102903|NCT01769365|E1|Reported Event|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
102904|NCT01769339|B1|Baseline|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
102972|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102905|NCT01769339|P1|Participant Flow|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically (applied to skin) to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis (yeast infection of the vulva) were not cured clinically on Day 14.
102906|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
102907|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
102908|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
102909|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
102910|NCT01769339|E1|Reported Event|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
102911|NCT01769326|B5|Baseline|Total|Total of all reporting groups
102912|NCT01769326|B4|Baseline|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
102913|NCT01769326|B3|Baseline|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program
Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
102914|NCT01769326|B2|Baseline|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
102994|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment"
102915|NCT01769326|B1|Baseline|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program
MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
102916|NCT01769326|P4|Participant Flow|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
102917|NCT01769326|P3|Participant Flow|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program
Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
102918|NCT01769326|P2|Participant Flow|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
102919|NCT01769326|P1|Participant Flow|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program
MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
102920|NCT01769326|O2|Outcome|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
102921|NCT01769326|O1|Outcome|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program
Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
102922|NCT01769326|O2|Outcome|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
102923|NCT01769326|O1|Outcome|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program
MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
102924|NCT01769326|E4|Reported Event|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
102925|NCT01769326|E3|Reported Event|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program
Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
102926|NCT01769326|E2|Reported Event|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
102973|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102927|NCT01769326|E1|Reported Event|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program
MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
102928|NCT01769248|B3|Baseline|Total|Total of all reporting groups
102929|NCT01769248|B2|Baseline|Fine Needle Biopsy|"Fine needle biopsy
Fine needle biopsy: FNB"
102930|NCT01769248|B1|Baseline|Fine Needle Aspiration|"fine needle aspiration
Fine needle aspiration: Fine needle aspiration"
102931|NCT01769248|P2|Participant Flow|Fine Needle Biopsy|"Fine needle biopsy
Fine needle biopsy: FNB, test arm for core biopsies, EUS-FNB"
102932|NCT01769248|P1|Participant Flow|Fine Needle Aspiration|"fine needle aspiration
Fine needle aspiration: Fine needle aspiration using EUS-FNA needles. This was the standard of care arm"
102933|NCT01769248|O2|Outcome|Fine Needle Biopsy|"Fine needle biopsy
Fine needle biopsy: FNB"
102934|NCT01769248|O1|Outcome|Fine Needle Aspiration|"fine needle aspiration
Fine needle aspiration: Fine needle aspiration"
102935|NCT01769248|E2|Reported Event|Fine Needle Biopsy|"Fine needle biopsy
Fine needle biopsy: FNB"
102936|NCT01769248|E1|Reported Event|Fine Needle Aspiration|Fine needle aspiration: Fine needle aspiration
102937|NCT01769222|B3|Baseline|Total|Total of all reporting groups
102938|NCT01769222|B2|Baseline|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions
Ipilimumab: Given intratumorally
Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
102939|NCT01769222|B1|Baseline|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1
Ipilimumab: Given intratumorally"
102940|NCT01769222|P2|Participant Flow|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions
Ipilimumab: Given intratumorally
Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
102941|NCT01769222|P1|Participant Flow|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1
Ipilimumab: Given intratumorally"
102942|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions
Ipilimumab: Given intratumorally
Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
102944|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions
Ipilimumab: Given intratumorally
Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
102945|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1
Ipilimumab: Given intratumorally"
102946|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions
Ipilimumab: Given intratumorally
Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
102947|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1
Ipilimumab: Given intratumorally"
102948|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions
Ipilimumab: Given intratumorally
Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
102949|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1
Ipilimumab: Given intratumorally"
102950|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions
Ipilimumab: Given intratumorally
Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
102951|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1
Ipilimumab: Given intratumorally"
102952|NCT01769222|E2|Reported Event|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions
Ipilimumab: Given intratumorally
Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
102953|NCT01769222|E1|Reported Event|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1
Ipilimumab: Given intratumorally"
102954|NCT01769196|B3|Baseline|Total|Total of all reporting groups
102955|NCT01769196|B2|Baseline|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102956|NCT01769196|B1|Baseline|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102957|NCT01769196|P2|Participant Flow|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102958|NCT01769196|P1|Participant Flow|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102959|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102960|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102961|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102962|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102963|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102964|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102965|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102966|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102967|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102968|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102969|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102975|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102976|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102977|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102978|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102979|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102980|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102981|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102982|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102983|NCT01769196|E2|Reported Event|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
102984|NCT01769196|E1|Reported Event|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
102985|NCT01769105|B3|Baseline|Total|Total of all reporting groups
102986|NCT01769105|B2|Baseline|Lipiflow|"Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment"
102987|NCT01769105|B1|Baseline|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily, then a single Lipiflow-treatment"
102988|NCT01769105|P2|Participant Flow|Lipiflow|"Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment"
102989|NCT01769105|P1|Participant Flow|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow treatment"
102990|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
102991|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment"
102992|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
102993|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
102998|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
102999|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
103000|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment"
103001|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
103002|NCT01769105|O3|Outcome|Cross-over Lipiflow|patients received a single Lipiflow treatment after performing lid hygiene for 3 month
103003|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment"
103004|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
103005|NCT01769105|E2|Reported Event|Lipiflow|"Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment"
103006|NCT01769105|E1|Reported Event|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily first and then Lipiflow
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow-treatment"
103007|NCT01768676|B3|Baseline|Total|Total of all reporting groups
103008|NCT01768676|B2|Baseline|Placebo|placebo taken once daily in the evening
103009|NCT01768676|B1|Baseline|Avanafil|100 mg once daily in the evening
103010|NCT01768676|P2|Participant Flow|Placebo|placebo taken once daily in the evening
103011|NCT01768676|P1|Participant Flow|Avanafil|100 mg once daily in the evening
103012|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
103013|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
103014|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
103015|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
103016|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
103017|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
103018|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
103019|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
103020|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
103021|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
103022|NCT01768676|E2|Reported Event|Placebo|placebo taken once daily in the evening
103023|NCT01768676|E1|Reported Event|Avanafil|100 mg once daily in the evening
103024|NCT01768572|B4|Baseline|Total|Total of all reporting groups
103111|NCT01768286|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
103025|NCT01768572|B3|Baseline|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator’s discretion.
103026|NCT01768572|B2|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
103027|NCT01768572|B1|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
103028|NCT01768572|P3|Participant Flow|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator’s discretion.
103029|NCT01768572|P2|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
103030|NCT01768572|P1|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD) for 24 weeks.
103031|NCT01768572|O3|Outcome|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator’s discretion.
103032|NCT01768572|O2|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
103033|NCT01768572|O1|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
103034|NCT01768572|E3|Reported Event|Tocilizumab q4w|Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Dose for tocilizumab could be up-titrated to 8 mg/kg or down-titrated to 4 mg/kg based on clinical response as per Investigator’s discretion.
103035|NCT01768572|E2|Reported Event|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
103036|NCT01768572|E1|Reported Event|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
103037|NCT01768559|B4|Baseline|Total|Total of all reporting groups
103038|NCT01768559|B3|Baseline|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.
103039|NCT01768559|B2|Baseline|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
103082|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103040|NCT01768559|B1|Baseline|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103041|NCT01768559|P3|Participant Flow|Insulin Glulisine TID|Insulin glulisine thrice daily (TID) SC up to Week 26 on top of insulin glargine with or without metformin.
103042|NCT01768559|P2|Participant Flow|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
103043|NCT01768559|P1|Participant Flow|Lixisenatide|Lixisenatide 10 mcg once daily (QD) subcutaneously (SC) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103044|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.
103045|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
103046|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103047|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103048|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103049|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103050|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103051|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103052|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103053|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103054|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103055|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103056|NCT01768559|O2|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103057|NCT01768559|O1|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103058|NCT01768559|O2|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103059|NCT01768559|O1|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103060|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103061|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103895|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month
Rowachol"
103062|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103063|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103064|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103065|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103066|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103067|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103068|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103069|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103070|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103071|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103072|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103073|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103074|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103075|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103076|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103077|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103078|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103079|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103080|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103081|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103083|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103084|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
103085|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
103086|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
103087|NCT01768559|E3|Reported Event|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).
103088|NCT01768559|E2|Reported Event|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).
103089|NCT01768559|E1|Reported Event|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin (Median exposure of 182 days).
103090|NCT01768325|B3|Baseline|Total|Total of all reporting groups
103091|NCT01768325|B2|Baseline|ProCore Needle|
103092|NCT01768325|B1|Baseline|QuickCore Needle|
103093|NCT01768325|P2|Participant Flow|ProCore Needle|
103094|NCT01768325|P1|Participant Flow|Quick Core Needle|
103095|NCT01768325|O2|Outcome|ProCore Needle|
103096|NCT01768325|O1|Outcome|Quick Core Needle|
103097|NCT01768325|O2|Outcome|ProCore Needle|
103098|NCT01768325|O1|Outcome|Quick Core Needle|
103099|NCT01768325|O2|Outcome|ProCore Needle|"Core biopsy needle comparison to obtain diagnostic yield.
Cook Medical core biopsy needle: Obtaining a larger specimen."
103100|NCT01768325|O1|Outcome|Quick Core Needle|"Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle
Cook Medical core biopsy needle: Obtaining a larger specimen."
103101|NCT01768325|E2|Reported Event|ProCore Needle|
103102|NCT01768325|E1|Reported Event|Quick Core Needle|
103103|NCT01768286|B5|Baseline|Total|Total of all reporting groups
103104|NCT01768286|B4|Baseline|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103105|NCT01768286|B3|Baseline|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103106|NCT01768286|B2|Baseline|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103107|NCT01768286|B1|Baseline|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103108|NCT01768286|P4|Participant Flow|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103109|NCT01768286|P3|Participant Flow|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103110|NCT01768286|P2|Participant Flow|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
105645|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
103112|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103113|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103114|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103115|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103116|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103117|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103118|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103119|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103120|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103121|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103122|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103123|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103124|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103125|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103126|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103127|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103128|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103129|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103130|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103131|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103132|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103133|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103134|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103135|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
109070|NCT01739803|E1|Reported Event|Intervention Group|Behavioral contract intervention
103136|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103137|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103138|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103139|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103140|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103141|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103142|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103143|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103144|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103145|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103146|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103147|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103148|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103149|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103150|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103151|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103152|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103153|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103154|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103155|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103156|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103157|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103158|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103159|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103160|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103161|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103896|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months
Placebo"
103162|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103163|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103164|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103165|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103166|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103167|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103168|NCT01768286|E4|Reported Event|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
103169|NCT01768286|E3|Reported Event|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
103170|NCT01768286|E2|Reported Event|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
103171|NCT01768286|E1|Reported Event|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
103172|NCT01768117|B1|Baseline|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
103173|NCT01768117|P1|Participant Flow|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
103174|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
103175|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
103176|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
103177|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
103178|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
103179|NCT01768117|E1|Reported Event|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
103180|NCT01768013|B1|Baseline|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103181|NCT01768013|P1|Participant Flow|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103250|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
109071|NCT01739595|B4|Baseline|Total|Total of all reporting groups
103182|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103183|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103184|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103185|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103186|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103187|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103188|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103189|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103190|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103191|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103192|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103193|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103194|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103195|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103196|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103197|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103198|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103251|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
109213|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
103199|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103200|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103201|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103202|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103203|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103204|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103205|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103206|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103207|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103208|NCT01768013|E1|Reported Event|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
103209|NCT01768000|B5|Baseline|Total|Total of all reporting groups
103237|NCT01767987|P2|Participant Flow|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
103210|NCT01768000|B4|Baseline|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103211|NCT01768000|B3|Baseline|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103212|NCT01768000|B2|Baseline|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103213|NCT01768000|B1|Baseline|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103214|NCT01768000|P4|Participant Flow|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103252|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
103253|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
103215|NCT01768000|P3|Participant Flow|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103216|NCT01768000|P2|Participant Flow|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103217|NCT01768000|P1|Participant Flow|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103218|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103219|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103220|NCT01768000|O2|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103221|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103222|NCT01768000|O4|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103223|NCT01768000|O3|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103224|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103225|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103226|NCT01768000|O4|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103254|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
103428|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
103227|NCT01768000|O3|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103228|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103229|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103230|NCT01768000|E4|Reported Event|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103231|NCT01768000|E3|Reported Event|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103232|NCT01768000|E2|Reported Event|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
103233|NCT01768000|E1|Reported Event|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
103234|NCT01767987|B3|Baseline|Total|Total of all reporting groups
103235|NCT01767987|B2|Baseline|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
103236|NCT01767987|B1|Baseline|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
109369|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
103238|NCT01767987|P1|Participant Flow|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
103239|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
103240|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
103241|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
103242|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
103243|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
103244|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
103245|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
103246|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
103247|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
103248|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
103249|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
110572|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
103255|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
103256|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
103257|NCT01767987|E2|Reported Event|Placebo|"Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
103258|NCT01767987|E1|Reported Event|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg
Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
103259|NCT01767701|B1|Baseline|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
Raltegravir: 400mg twice daily for 3 months"
103260|NCT01767701|P1|Participant Flow|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
Raltegravir: 400mg twice daily for 3 months"
103261|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
Raltegravir: 400mg twice daily for 3 months"
103262|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
Raltegravir: 400mg twice daily for 3 months"
103263|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
Raltegravir: 400mg twice daily for 3 months"
103264|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
Raltegravir: 400mg twice daily for 3 months"
103265|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily. The EDSS score is determined by the mean score over three months after treatment minus the mean score of the three months before treatment
Raltegravir: 400mg twice daily for 3 months"
103266|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
Raltegravir: 400mg twice daily for 3 months"
103267|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
Raltegravir: 400mg twice daily for 3 months"
103268|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
Raltegravir: 400mg twice daily for 3 months"
103351|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103269|NCT01767701|E1|Reported Event|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
Raltegravir: 400mg twice daily for 3 months"
103270|NCT01767688|B3|Baseline|Total|Total of all reporting groups
103271|NCT01767688|B2|Baseline|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
103272|NCT01767688|B1|Baseline|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
103273|NCT01767688|P2|Participant Flow|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
103274|NCT01767688|P1|Participant Flow|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
103275|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
103276|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
103277|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
103278|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
103279|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
103280|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
103281|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
103282|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
103283|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
103284|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
103285|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
103286|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
103287|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
103288|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
103289|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
103290|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
103291|NCT01767688|E2|Reported Event|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
103292|NCT01767688|E1|Reported Event|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
103293|NCT01767597|B3|Baseline|Total|Total of all reporting groups
103294|NCT01767597|B2|Baseline|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).
ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).
Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
103295|NCT01767597|B1|Baseline|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)
ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
103296|NCT01767597|P2|Participant Flow|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).
ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).
Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
103297|NCT01767597|P1|Participant Flow|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)
ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
103298|NCT01767597|O2|Outcome|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).
ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).
Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
103299|NCT01767597|O1|Outcome|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)
ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
103300|NCT01767597|E2|Reported Event|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).
ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).
Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
103301|NCT01767597|E1|Reported Event|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)
ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
103302|NCT01767519|B4|Baseline|Total|Total of all reporting groups
103303|NCT01767519|B3|Baseline|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103304|NCT01767519|B2|Baseline|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103305|NCT01767519|B1|Baseline|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
110633|NCT01732263|E2|Reported Event|Matched Healthy Subjects|
103306|NCT01767519|P3|Participant Flow|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103307|NCT01767519|P2|Participant Flow|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103308|NCT01767519|P1|Participant Flow|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
103309|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103310|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103311|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
103312|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103313|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103314|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
103315|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103316|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103317|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
103318|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103319|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103320|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
103897|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months
Rowachol"
103321|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103322|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103323|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
103324|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103325|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103326|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
103327|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103328|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103329|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
103330|NCT01767519|E3|Reported Event|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103331|NCT01767519|E2|Reported Event|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
103332|NCT01767519|E1|Reported Event|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
103333|NCT01767467|B3|Baseline|Total|Total of all reporting groups
103334|NCT01767467|B2|Baseline|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103335|NCT01767467|B1|Baseline|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103336|NCT01767467|P2|Participant Flow|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103337|NCT01767467|P1|Participant Flow|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103338|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103339|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103340|NCT01767467|O1|Outcome|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103341|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103342|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103343|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103344|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103345|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103346|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103347|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103348|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103349|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103350|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103352|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103353|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103354|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103355|NCT01767467|O1|Outcome|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103356|NCT01767467|O1|Outcome|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103357|NCT01767467|O1|Outcome|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103358|NCT01767467|O1|Outcome|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103359|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103360|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103361|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103362|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103363|NCT01767467|E1|Reported Event|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
103364|NCT01767285|B3|Baseline|Total|Total of all reporting groups
110634|NCT01732263|E1|Reported Event|Hepatic Impairment|
103365|NCT01767285|B2|Baseline|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103366|NCT01767285|B1|Baseline|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103367|NCT01767285|P2|Participant Flow|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103368|NCT01767285|P1|Participant Flow|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103369|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103370|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103371|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103372|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103373|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103374|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103375|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103376|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103377|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103378|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103379|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103380|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103381|NCT01767285|E2|Reported Event|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103382|NCT01767285|E1|Reported Event|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.
Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
103383|NCT01767116|B3|Baseline|Total|Total of all reporting groups
103384|NCT01767116|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
103385|NCT01767116|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
103386|NCT01767116|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
110635|NCT01733121|B3|Baseline|Total|Total of all reporting groups
103387|NCT01767116|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
103388|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
103389|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
103390|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
103391|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
103392|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
103393|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
103394|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
103395|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
103396|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
103397|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
103398|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
103399|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
103400|NCT01767116|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
103401|NCT01767116|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
103402|NCT01767103|B4|Baseline|Total|Total of all reporting groups
103403|NCT01767103|B3|Baseline|Moderate Hepatic Failure|Moderate hepatic failure as defined by Child-Pugh Class B: 7-9 points
103404|NCT01767103|B2|Baseline|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
103405|NCT01767103|B1|Baseline|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
103406|NCT01767103|P3|Participant Flow|Moderate Hepatic Failure|Moderate hepatic impairment as defined by Child-Pugh Class : 7-9 points. All subjects received a single 33 mg/kg oral dose of deferiprone.
103407|NCT01767103|P2|Participant Flow|Mild Hepatic Failure|Mild hepatic impairment as defined by Child-Pugh Class C: 5-6 points. All subjects received a single 33 mg/kg oral dose of deferiprone.
103408|NCT01767103|P1|Participant Flow|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function. All subjects received a single 33 mg/kg oral dose of deferiprone.
103409|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
103410|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
103411|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
103412|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
103413|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
103414|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
103415|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
103416|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
103417|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
103418|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
103419|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
103420|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
103421|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by Child-Pugh Class B: 7-9 points
103422|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
103423|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
103424|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
103425|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
103426|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
103427|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
103429|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
103430|NCT01767103|E3|Reported Event|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
103431|NCT01767103|E2|Reported Event|Mild Hepatic Failure|Mild hepatic failure as defined by the Child-Pugh Class C: 5-6 points
103432|NCT01767103|E1|Reported Event|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
103433|NCT01767064|B3|Baseline|Total|Total of all reporting groups
103434|NCT01767064|B2|Baseline|Control|Usual care with no posted letters.
103435|NCT01767064|B1|Baseline|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.
Posted commitment letter"
103436|NCT01767064|P2|Participant Flow|Control|Usual care with no posted letters.
103437|NCT01767064|P1|Participant Flow|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.
Posted commitment letter"
103438|NCT01767064|O2|Outcome|Control|Usual care with no posted letters.
103439|NCT01767064|O1|Outcome|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.
Posted commitment letter"
103440|NCT01767064|E2|Reported Event|Control|Usual care with no posted letters.
103441|NCT01767064|E1|Reported Event|Posted Commitment Letter|"The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.
Posted commitment letter"
103442|NCT01766921|B3|Baseline|Total|Total of all reporting groups
103443|NCT01766921|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103444|NCT01766921|B1|Baseline|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103445|NCT01766921|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103446|NCT01766921|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103447|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103448|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103449|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103450|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103451|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103452|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103453|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103454|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103455|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103456|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103457|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103458|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103459|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103460|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
103461|NCT01766921|E3|Reported Event|Total|Total of subjects in both high and low dose groups.
103462|NCT01766921|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 three weeks apart.
103463|NCT01766921|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
103464|NCT01766778|B3|Baseline|Total|Total of all reporting groups
103465|NCT01766778|B2|Baseline|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
105557|NCT01761279|E1|Reported Event|HDWL + I-Scan|High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
103466|NCT01766778|B1|Baseline|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
103467|NCT01766778|P2|Participant Flow|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
103468|NCT01766778|P1|Participant Flow|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
103469|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
103470|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
103471|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
103472|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
103473|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
103474|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
103475|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
103476|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
103477|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
103478|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
103479|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
103480|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
103481|NCT01766778|E2|Reported Event|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
103482|NCT01766778|E1|Reported Event|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
103483|NCT01766713|B3|Baseline|Total|Total of all reporting groups
103484|NCT01766713|B2|Baseline|Placebo|Placebo only
103485|NCT01766713|B1|Baseline|Ezetimibe|"10 mg/day of Ezetimibe
Ezetimibe"
103486|NCT01766713|P2|Participant Flow|Placebo|Placebo
103487|NCT01766713|P1|Participant Flow|Ezetimibe|"10 mg/day of Ezetimibe
Ezetimibe"
103488|NCT01766713|O2|Outcome|Placebo|Placebo
103489|NCT01766713|O1|Outcome|Ezetimibe|"10 mg/day of Ezetimibe
Ezetimibe"
103490|NCT01766713|E2|Reported Event|Placebo|
103491|NCT01766713|E1|Reported Event|Ezetimibe|"10 mg/day of Ezetimibe
Ezetimibe"
103492|NCT01766466|B3|Baseline|Total|Total of all reporting groups
103493|NCT01766466|B2|Baseline|ITT Population - Ticagrelor 7 Doses|"On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses.
On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 12 hours prior."
103538|NCT01766310|E1|Reported Event|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study
placebo: sugar tablet manufactured to mimic folic acid tablet"
103494|NCT01766466|B1|Baseline|ITT Population - Ticagrelor 6 Doses|"On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses.
On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 24 hours prior."
103495|NCT01766466|P4|Participant Flow|Day 5 - Ticagrelor (90mg) Dosing (7 Doses)|Ticagrelor (90mg) discontinued 12h prior to the initiation of a 2h cangrelor infusion.
103496|NCT01766466|P3|Participant Flow|Day 1 - Cangrelor + Ticagrelor (180mg) at 1.5h|Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 1.5h after the initiation of the cangrelor infusion.
103497|NCT01766466|P2|Participant Flow|Day 5 - Ticagrelor (90 mg) Dosing (6 Doses)|Ticagrelor (90mg) discontinued 24h prior to the initiation of a 2h cangrelor infusion.
103498|NCT01766466|P1|Participant Flow|Day 1 - Cangrelor + Ticagrelor (180mg) at 0.5h|Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 0.5h after the initiation of the cangrelor infusion.
103499|NCT01766466|O3|Outcome|Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
103500|NCT01766466|O2|Outcome|Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
103501|NCT01766466|O1|Outcome|All Patients|
103502|NCT01766466|O3|Outcome|Ticagrelor Discontinued 12 h Prior to Cangrelor Infusion|
103503|NCT01766466|O2|Outcome|Ticagrelor Discontinued 24 h Prior to Cangrelor Infusion|
103504|NCT01766466|O1|Outcome|All Patients|
103505|NCT01766466|O3|Outcome|Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
103506|NCT01766466|O2|Outcome|Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
103507|NCT01766466|O1|Outcome|All Patients|
103508|NCT01766466|E2|Reported Event|Cangrelor + Ticagrelor 90mg (7 Doses)|Ticagrelor discontinued 12 h prior to cangrelor infusion
103509|NCT01766466|E1|Reported Event|Cangrelor + Ticagrelor 90mg (6 Doses)|Ticagrelor was discontinued 24 h prior to cangrelor infusion
103510|NCT01766440|B1|Baseline|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
103511|NCT01766440|P1|Participant Flow|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
105558|NCT01761175|B3|Baseline|Total|Total of all reporting groups
103512|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
103513|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
103514|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
103515|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
103516|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
103517|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
103518|NCT01766440|E1|Reported Event|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days
Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
103519|NCT01766336|B3|Baseline|Total|Total of all reporting groups
103520|NCT01766336|B2|Baseline|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
103521|NCT01766336|B1|Baseline|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
103522|NCT01766336|P2|Participant Flow|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
103523|NCT01766336|P1|Participant Flow|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
103524|NCT01766336|O2|Outcome|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
103525|NCT01766336|O1|Outcome|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
103526|NCT01766336|E2|Reported Event|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
103527|NCT01766336|E1|Reported Event|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
103528|NCT01766310|B3|Baseline|Total|Total of all reporting groups
103529|NCT01766310|B2|Baseline|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Folic Acid"
103530|NCT01766310|B1|Baseline|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study
placebo: sugar tablet manufactured to mimic folic acid tablet"
103531|NCT01766310|P2|Participant Flow|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Folic Acid"
103532|NCT01766310|P1|Participant Flow|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study
placebo: sugar tablet manufactured to mimic folic acid tablet"
103533|NCT01766310|O2|Outcome|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Folic Acid"
103534|NCT01766310|O1|Outcome|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study
placebo: sugar tablet manufactured to mimic folic acid tablet"
103535|NCT01766310|O2|Outcome|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Folic Acid"
103536|NCT01766310|O1|Outcome|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study
placebo: sugar tablet manufactured to mimic folic acid tablet"
103537|NCT01766310|E2|Reported Event|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Folic Acid"
103540|NCT01766102|B2|Baseline|Standard Mammography|"Standard Specimen Mammography
Standard Mammography: There is not an added device associated with this arm."
103541|NCT01766102|B1|Baseline|Intra-operative Mammography|"Intra-operative Specimen Mammography
Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
103542|NCT01766102|P2|Participant Flow|Standard Mammography|"Standard Specimen Mammography
Standard Mammography: There is not an added device associated with this arm."
103543|NCT01766102|P1|Participant Flow|Intra-operative Mammography|"Intra-operative Specimen Mammography
Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
103544|NCT01766102|O2|Outcome|Standard Mammography|"Standard Specimen Mammography
Standard Mammography: There is not an added device associated with this arm."
103545|NCT01766102|O1|Outcome|Intra-operative Mammography|"Intra-operative Specimen Mammography
Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
103546|NCT01766102|O2|Outcome|Standard Mammography|"Standard Specimen Mammography
Standard Mammography: There is not an added device associated with this arm."
103547|NCT01766102|O1|Outcome|Intra-operative Mammography|"Intra-operative Specimen Mammography
Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
103548|NCT01766102|E2|Reported Event|Standard Mammography|"Standard Specimen Mammography
Standard Mammography: There is not an added device associated with this arm."
103549|NCT01766102|E1|Reported Event|Intra-operative Mammography|"Intra-operative Specimen Mammography
Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042"
103550|NCT01766076|B3|Baseline|Total|Total of all reporting groups
103551|NCT01766076|B2|Baseline|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry
Placebo: PBMC were collected for immune activation assays using flowcytometry"
103552|NCT01766076|B1|Baseline|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.
PBMC will be collected for immune activation assays using flowcytometry
'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry"
103553|NCT01766076|P2|Participant Flow|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC were collected for immune activation assays using flowcytometry
Placebo: PBMC were collected for immune activation assays using flowcytometry"
103554|NCT01766076|P1|Participant Flow|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.
PBMC were collected for immune activation assays using flowcytometry
'atorvastatin, Lipitor®': PBMC collected for immune activation assays using flowcytometry"
103555|NCT01766076|O2|Outcome|Placebo|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry
Placebo: PBMC were collected for immune activation assays using flowcytometry"
103556|NCT01766076|O1|Outcome|Atorvastatin|"Intervention is be atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.
PBMC were collected for immune activation assays using flowcytometry
'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry"
103557|NCT01766076|E2|Reported Event|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC wiere collected for immune activation assays using flowcytometry
Placebo: PBMC were collected for immune activation assays using flowcytometry"
103558|NCT01766076|E1|Reported Event|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.
PBMC were collected for immune activation assays using flowcytometry
'atorvastatin, Lipitor®': PBMCwere collected for immune activation assays using flowcytometry"
103559|NCT01766050|B1|Baseline|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103560|NCT01766050|P1|Participant Flow|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103561|NCT01766050|O1|Outcome|Post Treatment|Days 12 through 46 (Day of Discharge from Study). No study drug was administered during this time.
103562|NCT01766050|O1|Outcome|Post Treatment|Days 12 through 46 (Day of Discharge from Study). No study drug was administered during this time.
103563|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103564|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103565|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
103566|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103567|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103568|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103569|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
103570|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103571|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103572|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103573|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103574|NCT01766050|O5|Outcome|All Participants|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103575|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103576|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103577|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
103578|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103579|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103580|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103581|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
103582|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103583|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103584|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103585|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103586|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103587|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103588|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103589|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103716|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103590|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103591|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103592|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103593|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered on Day 4.
103594|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day1.
103595|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103596|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103597|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103598|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103728|NCT01766037|E2|Reported Event|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103599|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day11.
103600|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103601|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103602|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 1.
103603|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103604|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103605|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103606|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103607|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103608|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103609|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103610|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103611|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1, 4, 7 and 11.
103612|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103613|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103614|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103615|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103616|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103617|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103618|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103619|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103620|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103621|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
103622|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103623|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103624|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103625|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
103626|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103627|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103628|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103629|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
103630|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103631|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103632|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103633|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
103634|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103635|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103636|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103637|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
109370|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
103638|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103639|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103640|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103641|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
103642|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103643|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103644|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103645|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
103646|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103647|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103648|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103649|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
103650|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103651|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103652|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103653|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103654|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103655|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103656|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103657|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103658|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103659|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103660|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103661|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103662|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103663|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103664|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103665|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103666|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103667|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103668|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103669|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103670|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103671|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103672|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103673|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103674|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103675|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103676|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103677|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103678|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103679|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103680|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103681|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103682|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103683|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103684|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103685|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103686|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103687|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
103688|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
103689|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
103690|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
103691|NCT01766050|E1|Reported Event|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
103692|NCT01766037|B3|Baseline|Total|Total of all reporting groups
103693|NCT01766037|B2|Baseline|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103694|NCT01766037|B1|Baseline|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103695|NCT01766037|P2|Participant Flow|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103696|NCT01766037|P1|Participant Flow|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103697|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103698|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103699|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103700|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103701|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103702|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103703|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103704|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103705|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103706|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103707|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103708|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103709|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103710|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103711|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103712|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103713|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103714|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103715|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103717|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103718|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103719|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103720|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103721|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103722|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103723|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103724|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103725|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103726|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103727|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103840|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
103729|NCT01766037|E1|Reported Event|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
103730|NCT01766024|B3|Baseline|Total|Total of all reporting groups
103731|NCT01766024|B2|Baseline|Rebif → BCD-033|"Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.
Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
103732|NCT01766024|B1|Baseline|BCD-033 → Rebif|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.
Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
103733|NCT01766024|P2|Participant Flow|Rebif → BCD-033|"Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.
Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
103734|NCT01766024|P1|Participant Flow|BCD-033 → Rebif|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.
Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
103735|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif
103736|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
103737|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif (interferon beta-1a) a
103738|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033 (interferon beta-1a)
103739|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif
103740|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
103741|NCT01766024|E2|Reported Event|Rebif|the endpoint was assessed in all the volunteer who received Rebif
103742|NCT01766024|E1|Reported Event|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
103743|NCT01765972|B1|Baseline|Overall|All subjects that were dispensed a study lens.
103744|NCT01765972|P4|Participant Flow|Spectacle/ Test 2/ Test 1/ Test 3|Subjects received spectacle and then received Test 2 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 3 (etafilcon A with print) .
103745|NCT01765972|P3|Participant Flow|Test 3/ Test 1/ Test 2/ Spectacle|Subjects received Test 3 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 2 (etafilcon A with print) and then received spectacle.
103746|NCT01765972|P2|Participant Flow|Test 2/ Test 3/ Spectacle/ Test 1|Subjects received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print) and then received spectacle and then received Test 1 (etafilcon A with Laceron).
103889|NCT01765465|P1|Participant Flow|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months
Rowachol"
103747|NCT01765972|P1|Participant Flow|Test 1/Spectacle/Test 2/ Test 3|Subjects received Test 1 (etafilcon A with Laceron) and then received spectacle and then received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print).
103748|NCT01765972|O4|Outcome|Spectacle|Subjects that wore spectacles in any of the 4 periods of this study.
103749|NCT01765972|O3|Outcome|Test 3 (Etafilcon A With Print)|Subjects that received Test 3 (etafilcon A with print) lens in any of the 4 periods of this study.
103750|NCT01765972|O2|Outcome|Test 2 (Etafilcon A With Lacreon With Print)|Subjects that received Test 2 (etafilcon A with Lacreon with print) lens in any of the 4 periods of this study.
103751|NCT01765972|O1|Outcome|Test 1 (Etafilcon A With Lacreon)|Subjects that received Test 1 (etafilcon A with Lacreon) lens in any of the 4 periods of this study.
103752|NCT01765972|E4|Reported Event|Test 3 (Etafilcon A With Print)|Subjects received Test 3 (etafilcon A with print) in any of the 4 periods of this study.
103753|NCT01765972|E3|Reported Event|Test 2 (Etafilcon A With Lacreon With Print)|Subjects received Test 2 (etafilcon A with Lacreon with print) in any of the 4 periods of this study.
103754|NCT01765972|E2|Reported Event|Test 1 (Etafilcon A With Lacreon)|Subjects received Test 1 (etafilcon A with Lacreon) in any of the 4 periods of this study.
103755|NCT01765972|E1|Reported Event|Spectacle|Subjects wore spectacles in any of the 4 periods of this study.
103756|NCT01764841|B5|Baseline|Total|Total of all reporting groups
103757|NCT01764841|B4|Baseline|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
103758|NCT01764841|B3|Baseline|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
103759|NCT01764841|B2|Baseline|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
103760|NCT01764841|B1|Baseline|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
103761|NCT01764841|P4|Participant Flow|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
103762|NCT01764841|P3|Participant Flow|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
103763|NCT01764841|P2|Participant Flow|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
103764|NCT01764841|P1|Participant Flow|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
103765|NCT01764841|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
103766|NCT01764841|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
103767|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
103768|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
103769|NCT01764841|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
103770|NCT01764841|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
103771|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
103772|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
103890|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month
Placebo"
103773|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
103774|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
103775|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
103776|NCT01764841|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
103777|NCT01764841|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
103778|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
103779|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
103841|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
103780|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
103781|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
103782|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
103783|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
103784|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
103785|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
103786|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
103787|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
103788|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
103789|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
103790|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
103791|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
103792|NCT01764841|E3|Reported Event|Pooled Placebo|Participants received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
103793|NCT01764841|E2|Reported Event|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
103794|NCT01764841|E1|Reported Event|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
103795|NCT01764685|B3|Baseline|Total|Total of all reporting groups
103796|NCT01764685|B2|Baseline|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit
Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
103797|NCT01764685|B1|Baseline|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 wks + Medical Management sessions for 15-25 mins per study visit
Topiramate: Max therapeutic dose of 150mg/day
Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 mins) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
103798|NCT01764685|P2|Participant Flow|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit
Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
103799|NCT01764685|P1|Participant Flow|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 weeks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit
Topiramate: Max therapeutic dose of 150 mg/day
Medical Management: (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
103800|NCT01764685|O2|Outcome|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit
Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
103801|NCT01764685|O1|Outcome|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 wks + Medical Management sessions for 15-25 mins per study visit
Topiramate: Max therapeutic dose of 150mg/day
Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/wk."
103802|NCT01764685|E2|Reported Event|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit
Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
103891|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month
Rowachol"
103892|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month
Placebo"
103803|NCT01764685|E1|Reported Event|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit
Topiramate: Max therapeutic dose of 150mg/day
Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drink"
103804|NCT01765803|B1|Baseline|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study
Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
103805|NCT01765803|P1|Participant Flow|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study
Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
103806|NCT01765803|O1|Outcome|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study
Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
103842|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
103807|NCT01765803|O1|Outcome|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study
Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
103808|NCT01765803|E1|Reported Event|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study
Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
103809|NCT01765764|B4|Baseline|Total|Total of all reporting groups
103810|NCT01765764|B3|Baseline|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
103811|NCT01765764|B2|Baseline|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
103812|NCT01765764|B1|Baseline|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
103813|NCT01765764|P3|Participant Flow|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
103814|NCT01765764|P2|Participant Flow|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
103815|NCT01765764|P1|Participant Flow|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
103816|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
103817|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
103818|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
103819|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
103820|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
103821|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
103822|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
103823|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
103824|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
103825|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
103826|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
103827|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
103828|NCT01765764|E3|Reported Event|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
103829|NCT01765764|E2|Reported Event|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
103830|NCT01765764|E1|Reported Event|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
103893|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month
Rowachol"
103831|NCT01765569|B1|Baseline|Vemurafenib + Digoxin|"Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.
Digoxin: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.
Vemurafenib: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35."
103832|NCT01765569|P1|Participant Flow|Vemurafenib + Digoxin|"Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.
Digoxin: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.
Vemurafenib: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35."
103833|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
103834|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
103835|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
103836|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
103837|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
103838|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
103839|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
103843|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
103844|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
103845|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
103846|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
103847|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
103848|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
103849|NCT01765569|E3|Reported Event|Period C|Single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35.
103850|NCT01765569|E2|Reported Event|Period B|Vemurafenib 960 mg orally BID from Day 8 to Day 28.
103851|NCT01765569|E1|Reported Event|Period A|Single oral dose of digoxin 0.25 mg tablet on Day 1.
103852|NCT01765543|B1|Baseline|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
103853|NCT01765543|P1|Participant Flow|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib (Zelboraf) at a dose of 960 milligrams (mg) as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
103854|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
103855|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
103856|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
103857|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
103858|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
103859|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
103894|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month
Placebo"
103860|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
103861|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
103862|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
103863|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
103864|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
103865|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
103866|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
103867|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
103868|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
103869|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
103870|NCT01765543|E4|Reported Event|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
103871|NCT01765543|E3|Reported Event|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
103872|NCT01765543|E2|Reported Event|Rifampin (Intervention Period B)|Participants received rifampin alone at a dose of 600 mg as capsules orally once daily from Days 8 through 16.
103873|NCT01765543|E1|Reported Event|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
103874|NCT01765530|B3|Baseline|Total|Total of all reporting groups
103875|NCT01765530|B2|Baseline|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
103876|NCT01765530|B1|Baseline|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
103877|NCT01765530|P2|Participant Flow|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
103878|NCT01765530|P1|Participant Flow|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
103879|NCT01765530|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
103880|NCT01765530|O1|Outcome|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
103881|NCT01765530|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
103882|NCT01765530|O1|Outcome|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
103883|NCT01765530|E2|Reported Event|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
103884|NCT01765530|E1|Reported Event|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
103885|NCT01765465|B3|Baseline|Total|Total of all reporting groups
103886|NCT01765465|B2|Baseline|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months
Placebo"
103887|NCT01765465|B1|Baseline|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months
Rowachol"
103888|NCT01765465|P2|Participant Flow|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months
Placebo"
103898|NCT01765465|E2|Reported Event|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months
Placebo"
103899|NCT01765465|E1|Reported Event|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months
Rowachol"
103900|NCT01765426|B5|Baseline|Total|Total of all reporting groups
103901|NCT01765426|B4|Baseline|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103902|NCT01765426|B3|Baseline|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103903|NCT01765426|B2|Baseline|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103904|NCT01765426|B1|Baseline|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103905|NCT01765426|P4|Participant Flow|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103906|NCT01765426|P3|Participant Flow|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103907|NCT01765426|P2|Participant Flow|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103908|NCT01765426|P1|Participant Flow|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103909|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103910|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103911|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103912|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103913|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103914|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103915|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103916|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103917|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103918|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103919|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103920|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103921|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103922|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103923|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
109371|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
103924|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103925|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103926|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103927|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103928|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103929|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103930|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103931|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103932|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103933|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103934|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103935|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103936|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103937|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103938|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103939|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103940|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103941|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103942|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103943|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103944|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103945|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103946|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103947|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
109372|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
103948|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103949|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103950|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103951|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103952|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103953|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103954|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103955|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103956|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103957|NCT01765426|E4|Reported Event|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103958|NCT01765426|E3|Reported Event|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
103959|NCT01765426|E2|Reported Event|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103960|NCT01765426|E1|Reported Event|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
103961|NCT01765270|B3|Baseline|Total|Total of all reporting groups
103962|NCT01765270|B2|Baseline|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103963|NCT01765270|B1|Baseline|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103964|NCT01765270|P2|Participant Flow|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103965|NCT01765270|P1|Participant Flow|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103966|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103967|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103968|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103969|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.daily
103970|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103971|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103972|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103973|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103974|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103975|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103976|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103977|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103978|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103979|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103980|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103981|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103982|NCT01765270|E2|Reported Event|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103983|NCT01765270|E1|Reported Event|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
103984|NCT01765192|B3|Baseline|Total|Total of all reporting groups
103985|NCT01765192|B2|Baseline|Placebo Plus Montelukast, Then Roflumilast Plus Montelukast|Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
103986|NCT01765192|B1|Baseline|Roflumilast Plus Montelukast, Then Placebo Plus Montelukast|Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks.
103987|NCT01765192|P2|Participant Flow|Placebo Plus Montelukast, Then Roflumilast Plus Montelukast|Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
103988|NCT01765192|P1|Participant Flow|Roflumilast Plus Montelukast, Then Placebo Plus Montelukast|Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks.
103989|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
103990|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
103991|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
103992|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
103993|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
103994|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
103995|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
103996|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
103997|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
103998|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
103999|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
104000|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
104001|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
104002|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
104003|NCT01765192|E2|Reported Event|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
104004|NCT01765192|E1|Reported Event|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
104005|NCT01765153|B3|Baseline|Total|Total of all reporting groups
104121|NCT01764997|O3|Outcome|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104006|NCT01765153|B2|Baseline|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104007|NCT01765153|B1|Baseline|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104008|NCT01765153|P2|Participant Flow|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training, which is followed by another 2-month rest.
104009|NCT01765153|P1|Participant Flow|Endurance First|Participants start with Endurance Training. Participants trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Precision Training 5x/wk for 2 months. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104132|NCT01764997|O1|Outcome|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
104306|NCT01763918|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104010|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104011|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104012|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104013|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104014|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104015|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104016|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104017|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104018|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
104019|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104020|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104021|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104022|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
104023|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104024|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
104025|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104026|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104027|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104028|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104029|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104030|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104031|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104032|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104033|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104034|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104035|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104036|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104037|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104038|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104039|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104040|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104041|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104042|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104043|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104044|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104045|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104046|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104047|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104048|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104049|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104050|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104051|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104052|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104053|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104054|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104055|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104056|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104057|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104058|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104059|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104060|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104061|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104062|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104063|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104064|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104065|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104066|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104067|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104068|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104069|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104070|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104071|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104072|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104073|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104074|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104075|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104076|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104077|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104078|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104079|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104080|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104081|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104082|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104083|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104084|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104085|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104086|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
104087|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104088|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104089|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104090|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104091|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104092|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104093|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104094|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
104095|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104096|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
104097|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104098|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
104099|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104100|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
104101|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104102|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
104103|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104104|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104105|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Trainingis 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104106|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104107|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104108|NCT01765153|E2|Reported Event|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
104109|NCT01765153|E1|Reported Event|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
104110|NCT01764997|B6|Baseline|Total|Total of all reporting groups
104111|NCT01764997|B5|Baseline|Sarilumab 150 mg + MTX Open Label Sub-study|Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX.
104112|NCT01764997|B4|Baseline|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104113|NCT01764997|B3|Baseline|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104114|NCT01764997|B2|Baseline|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
104115|NCT01764997|B1|Baseline|Adalimumab Open Label run-in Treatment Only|Adalimumab 40 mg SC injection Q2W for 16 weeks added to stable dose of MTX during run-in period. Participants who were not randomized in the main study or did not enter the sub-study were included in this arm for safety assessment.
104116|NCT01764997|P5|Participant Flow|Sarilumab 150 mg + MTX Open Label Sub-study|Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX.
104117|NCT01764997|P4|Participant Flow|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104118|NCT01764997|P3|Participant Flow|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104119|NCT01764997|P2|Participant Flow|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
104120|NCT01764997|P1|Participant Flow|Adalimumab Open Label run-in|Adalimumab 40 mg subcutaneous (SC) injection every 2 weeks (Q2W) for 16 weeks added to stable dose of methotrexate (MTX).
104122|NCT01764997|O2|Outcome|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104123|NCT01764997|O1|Outcome|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
104124|NCT01764997|O3|Outcome|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104125|NCT01764997|O2|Outcome|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104126|NCT01764997|O1|Outcome|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
104127|NCT01764997|O3|Outcome|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104128|NCT01764997|O2|Outcome|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104129|NCT01764997|O1|Outcome|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX.
104130|NCT01764997|O3|Outcome|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104131|NCT01764997|O2|Outcome|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
104133|NCT01764997|E5|Reported Event|Sarilumab 150 mg + MTX Open Label Sub-study|Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX. AEs in this group were those collected from enrollment in the sub-study up to the final visit (Week 58).
104134|NCT01764997|E4|Reported Event|Sarilumab 200 mg + MTX (Randomized)|Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
104135|NCT01764997|E3|Reported Event|Sarilumab 150 mg + MTX (Randomized)|Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
104136|NCT01764997|E2|Reported Event|Etanercept + MTX (Randomized)|Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30).
104137|NCT01764997|E1|Reported Event|Adalimumab Open Label run-in|Adalimumab 40 mg SC injection Q2W for 16 weeks added to stable dose of MTX. AEs in this group were those collected from signature of the informed consent form up to the end of Adalimumab treatment (Week 16).
104138|NCT01764945|B9|Baseline|Total|Total of all reporting groups
104139|NCT01764945|B8|Baseline|120mg Faldaprevir: Sequence Group HGEF|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104140|NCT01764945|B7|Baseline|120mg Faldaprevir: Sequence Group GFHE|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104141|NCT01764945|B6|Baseline|120mg Faldaprevir: Sequence Group FEGH|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104142|NCT01764945|B5|Baseline|120mg Faldaprevir: Sequence Group EHFG|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104143|NCT01764945|B4|Baseline|40mg Faldaprevir: Sequence Group DCAB|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104144|NCT01764945|B3|Baseline|40mg Faldaprevir: Sequence Group CBDA|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104145|NCT01764945|B2|Baseline|40mg Faldaprevir: Sequence Group BACD|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104146|NCT01764945|B1|Baseline|40mg Faldaprevir: Sequence Group ADBC|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104147|NCT01764945|P8|Participant Flow|120mg Faldaprevir: Sequence Group HGEF|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104148|NCT01764945|P7|Participant Flow|120mg Faldaprevir: Sequence Group GFHE|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104149|NCT01764945|P6|Participant Flow|120mg Faldaprevir: Sequence Group FEGH|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104150|NCT01764945|P5|Participant Flow|120mg Faldaprevir: Sequence Group EHFG|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).
The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104151|NCT01764945|P4|Participant Flow|40mg Faldaprevir: Sequence Group DCAB|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104152|NCT01764945|P3|Participant Flow|40mg Faldaprevir: Sequence Group CBDA|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104153|NCT01764945|P2|Participant Flow|40mg Faldaprevir: Sequence Group BACD|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104154|NCT01764945|P1|Participant Flow|40mg Faldaprevir: Sequence Group ADBC|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).
The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.
Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
104155|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
104156|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
104157|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
104158|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
104159|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
104160|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
104161|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
104162|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
104163|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
104164|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
104165|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
104166|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
104167|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
104168|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
104169|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
104170|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
104171|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
104172|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
104173|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
104174|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
104175|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
104176|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
104177|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
104178|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
104179|NCT01764945|E8|Reported Event|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3.
104180|NCT01764945|E7|Reported Event|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2.
104181|NCT01764945|E6|Reported Event|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1.
104182|NCT01764945|E5|Reported Event|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
104183|NCT01764945|E4|Reported Event|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3.
104184|NCT01764945|E3|Reported Event|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2.
104185|NCT01764945|E2|Reported Event|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1.
104186|NCT01764945|E1|Reported Event|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
104187|NCT01764919|B1|Baseline|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
104188|NCT01764919|P1|Participant Flow|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
104189|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
104304|NCT01763918|B3|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104190|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
104191|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
104192|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
104193|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
104194|NCT01764919|E1|Reported Event|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
104195|NCT01764607|B1|Baseline|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
104196|NCT01764607|P1|Participant Flow|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
104197|NCT01764607|O1|Outcome|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
104198|NCT01764607|O1|Outcome|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
104199|NCT01764607|E1|Reported Event|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
104200|NCT01764386|B3|Baseline|Total|Total of all reporting groups
104201|NCT01764386|B2|Baseline|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104202|NCT01764386|B1|Baseline|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104203|NCT01764386|P2|Participant Flow|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.
The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to Usual Care were switched to NB+CLI for the duration of the study (Week 78)."
104204|NCT01764386|P1|Participant Flow|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.
The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study (Week 78)."
104205|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104206|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104207|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104208|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104209|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104305|NCT01763918|B2|Baseline|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104210|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104211|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104212|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104213|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104214|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104215|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104216|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104217|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104218|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104219|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104220|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104221|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104222|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104223|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104224|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104285|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104225|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104226|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104227|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104228|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104229|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104230|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104231|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104232|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104233|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104234|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104235|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104236|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104237|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104238|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104239|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
104240|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
104241|NCT01764386|E3|Reported Event|All Subjects (Entire Study)|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.
All Subjects (Entire Study) consisted of all subjects in both the Controlled and Uncontrolled Treatment Periods. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study and subjects assigned to Usual Care were switched to NB+CLI for the duration of the study."
104242|NCT01764386|E2|Reported Event|Usual Care (Controlled Treatment Period)|"Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.
The Controlled Treatment Period was from Day 1 to Week 26."
104243|NCT01764386|E1|Reported Event|NB + CLI (Controlled Treatment Period)|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)
NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.
The Controlled Treatment Period was from Day 1 to Week 26."
104244|NCT01764022|B3|Baseline|Total|Total of all reporting groups
104245|NCT01764022|B2|Baseline|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104246|NCT01764022|B1|Baseline|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104247|NCT01764022|P2|Participant Flow|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104248|NCT01764022|P1|Participant Flow|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104249|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104250|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104353|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104251|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104252|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104253|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104254|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104255|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104256|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104257|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104258|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104259|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104260|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104261|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104286|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104287|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104288|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104262|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104263|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104264|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104265|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104266|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104267|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104268|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104269|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104270|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104271|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104272|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104273|NCT01764022|E2|Reported Event|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104274|NCT01764022|E1|Reported Event|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
104275|NCT01763996|B1|Baseline|All Participants|All participants who were randomized and received study drug (febuxostat 80 mg and placebo) during the study.
104276|NCT01763996|P2|Participant Flow|Sequence 2: Placebo + Febuxostat 80 mg|Febuxostat placebo-matching capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 2.
104277|NCT01763996|P1|Participant Flow|Sequence 1: Febuxostat 80 mg + Placebo|Febuxostat 80 mg, capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 2.
104278|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104279|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104280|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104281|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104282|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104283|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104284|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104289|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104290|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104291|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104292|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104293|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104294|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104295|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104296|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104297|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104298|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104299|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104300|NCT01763996|E2|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104301|NCT01763996|E1|Reported Event|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
104302|NCT01763918|B5|Baseline|Total|Total of all reporting groups
104303|NCT01763918|B4|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104307|NCT01763918|P4|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104308|NCT01763918|P3|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104309|NCT01763918|P2|Participant Flow|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104310|NCT01763918|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104311|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104312|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104313|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104314|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104315|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104316|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104317|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104318|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104319|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104320|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104321|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104322|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104323|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104324|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104325|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104326|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104327|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104328|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104329|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104330|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104331|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104332|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104333|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104334|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104335|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104336|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104504|NCT01763866|B25|Baseline|Total|Total of all reporting groups
104337|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104338|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104339|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104340|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104341|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104342|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104343|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104344|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104345|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104346|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104347|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104348|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104349|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104350|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104351|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104352|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104354|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104355|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104356|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104357|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104358|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104359|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104360|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104361|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104362|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104363|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104364|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104365|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104366|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104367|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104368|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104369|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104370|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104371|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104372|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104373|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104374|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104375|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104376|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104377|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104378|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104379|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104380|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104381|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104382|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104383|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104384|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104385|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104386|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104387|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104388|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104389|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104390|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104391|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104392|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104393|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104394|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104395|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104396|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104397|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104398|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104399|NCT01763918|E4|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104400|NCT01763918|E3|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104401|NCT01763918|E2|Reported Event|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
104402|NCT01763918|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
104403|NCT01763905|B5|Baseline|Total|Total of all reporting groups
104404|NCT01763905|B4|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104405|NCT01763905|B3|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104406|NCT01763905|B2|Baseline|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104407|NCT01763905|B1|Baseline|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104408|NCT01763905|P4|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104409|NCT01763905|P3|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104410|NCT01763905|P2|Participant Flow|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104411|NCT01763905|P1|Participant Flow|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104412|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104413|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104414|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104415|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104416|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104417|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104418|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104419|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104420|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104421|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104422|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104423|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104424|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104425|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105779|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
104426|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104427|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104428|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104429|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104430|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104431|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104432|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104433|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104434|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104435|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104436|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104437|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104438|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104439|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104440|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104441|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104442|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104443|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104444|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104445|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104446|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104447|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104448|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104449|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104450|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104451|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104452|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104453|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104454|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104455|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104456|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104457|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104458|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104459|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104460|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104461|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104462|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104463|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104464|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104465|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104466|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104467|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104468|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104469|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104470|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104471|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104472|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104473|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104474|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104475|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104476|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104477|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104478|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104479|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104480|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104481|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104482|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104483|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104484|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104485|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104486|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104487|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104488|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104489|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104490|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104491|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104492|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104493|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104494|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104495|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104496|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104497|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104498|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104499|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104500|NCT01763905|E4|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
104501|NCT01763905|E3|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104502|NCT01763905|E2|Reported Event|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104503|NCT01763905|E1|Reported Event|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
104505|NCT01763866|B24|Baseline|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104506|NCT01763866|B23|Baseline|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104507|NCT01763866|B22|Baseline|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104508|NCT01763866|B21|Baseline|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104509|NCT01763866|B20|Baseline|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104510|NCT01763866|B19|Baseline|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104511|NCT01763866|B18|Baseline|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104512|NCT01763866|B17|Baseline|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104513|NCT01763866|B16|Baseline|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104514|NCT01763866|B15|Baseline|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105216|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
104515|NCT01763866|B14|Baseline|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104516|NCT01763866|B13|Baseline|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104517|NCT01763866|B12|Baseline|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104518|NCT01763866|B11|Baseline|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104519|NCT01763866|B10|Baseline|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104520|NCT01763866|B9|Baseline|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104521|NCT01763866|B8|Baseline|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104522|NCT01763866|B7|Baseline|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104523|NCT01763866|B6|Baseline|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104524|NCT01763866|B5|Baseline|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104525|NCT01763866|B4|Baseline|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104526|NCT01763866|B3|Baseline|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104527|NCT01763866|B2|Baseline|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104528|NCT01763866|B1|Baseline|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104529|NCT01763866|P24|Participant Flow|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104530|NCT01763866|P23|Participant Flow|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104531|NCT01763866|P22|Participant Flow|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104532|NCT01763866|P21|Participant Flow|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104533|NCT01763866|P20|Participant Flow|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104534|NCT01763866|P19|Participant Flow|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104535|NCT01763866|P18|Participant Flow|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104536|NCT01763866|P17|Participant Flow|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104537|NCT01763866|P16|Participant Flow|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104538|NCT01763866|P15|Participant Flow|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104539|NCT01763866|P14|Participant Flow|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104540|NCT01763866|P13|Participant Flow|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104541|NCT01763866|P12|Participant Flow|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104651|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104542|NCT01763866|P11|Participant Flow|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104543|NCT01763866|P10|Participant Flow|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104544|NCT01763866|P9|Participant Flow|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104545|NCT01763866|P8|Participant Flow|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104546|NCT01763866|P7|Participant Flow|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104547|NCT01763866|P6|Participant Flow|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104548|NCT01763866|P5|Participant Flow|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104549|NCT01763866|P4|Participant Flow|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104550|NCT01763866|P3|Participant Flow|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104551|NCT01763866|P2|Participant Flow|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104552|NCT01763866|P1|Participant Flow|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104553|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104554|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104555|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104556|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104557|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104558|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104559|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105125|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
104560|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104561|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104562|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104563|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104564|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104565|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104566|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104567|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104568|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104569|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104570|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104571|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104572|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104573|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104574|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104575|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104576|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104577|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104578|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104579|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104580|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104581|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104582|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104583|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104584|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104585|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104586|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104587|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
109972|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
104588|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104589|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104590|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104591|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104592|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104593|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104594|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104595|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105934|NCT01757691|E1|Reported Event|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
104596|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104597|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104598|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104599|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104600|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104601|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104602|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104603|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104604|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104605|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104606|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104607|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104608|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104609|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104610|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104611|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104612|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104613|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104614|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104615|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104616|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104617|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104618|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104619|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104620|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104621|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104622|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104679|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104623|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104624|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104625|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104626|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104627|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104628|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104629|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104630|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104631|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104632|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104633|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104634|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104635|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104636|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104637|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104638|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104639|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104640|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104641|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104642|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104643|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104644|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104645|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104646|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104647|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104648|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104649|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104650|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104652|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104653|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104654|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104655|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104656|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104657|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104658|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104659|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104660|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104661|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104662|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104663|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104664|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104665|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104666|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104667|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104668|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104669|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104670|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104699|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104671|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104672|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104673|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104674|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104675|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104676|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104677|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104678|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105935|NCT01757561|B5|Baseline|Total|Total of all reporting groups
104680|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104681|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104682|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104683|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104684|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104685|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104686|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104687|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104688|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104689|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104690|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104691|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104692|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104693|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104694|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104695|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104696|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104697|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104698|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104700|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104701|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104702|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104703|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104704|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104705|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104706|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104707|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104708|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104709|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104710|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104711|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104712|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104713|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104714|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104715|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104716|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104717|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104718|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104719|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104720|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104721|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104722|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104723|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104724|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104725|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104726|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104727|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104728|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104729|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104730|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104731|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104732|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104733|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104734|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104735|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104791|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104736|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104737|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104738|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104739|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104740|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104741|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104742|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104743|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104744|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104745|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104746|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104747|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104748|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104749|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104750|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104751|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104752|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104753|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104754|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104755|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104756|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104757|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104758|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104759|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104760|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104761|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104762|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104763|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104764|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104765|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104766|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104767|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104768|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104769|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104770|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104771|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104772|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104773|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104774|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104775|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104776|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104777|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104778|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104779|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104780|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104781|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104782|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104783|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104784|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104785|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104786|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104787|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104788|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104789|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104790|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104847|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104792|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104793|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104794|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104795|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104796|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104797|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104798|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104799|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104800|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104801|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104802|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104803|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104804|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104805|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104806|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104807|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104808|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104809|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104810|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104811|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104812|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104813|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104814|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104815|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104816|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104817|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104818|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104819|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104820|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104821|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104822|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104823|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104824|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104825|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104826|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104827|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104828|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104829|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104830|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104831|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104832|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104833|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104834|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104835|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104836|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104837|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104838|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104867|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104839|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104840|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104841|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104842|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104843|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104844|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104845|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104846|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104848|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104849|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104850|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104851|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104852|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104853|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104854|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104855|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104856|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104857|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104858|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104859|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104860|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104861|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104862|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104863|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104864|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104865|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104866|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104868|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104869|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104870|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104871|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104872|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104873|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104874|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104875|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104876|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104877|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104878|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104879|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104880|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104881|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104882|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104883|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104884|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104885|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104886|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104887|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104888|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104889|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104890|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104891|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104892|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104893|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104894|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104895|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104896|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104897|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104898|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104899|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104900|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104901|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104902|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104903|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104959|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104904|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104905|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104906|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104907|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104908|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104909|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104910|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104911|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104912|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104913|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104914|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104915|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104916|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104917|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104918|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104919|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104920|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104921|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104922|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104923|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104924|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104925|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104926|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104927|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104928|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104929|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104930|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104931|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104932|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104933|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104934|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104935|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104936|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104937|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104938|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104939|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104940|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104941|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104942|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104943|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104944|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104945|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104946|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104947|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104948|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104949|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104950|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104951|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104952|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104953|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104954|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104955|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104956|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104957|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104958|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
105015|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104960|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104961|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104962|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104963|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104964|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104965|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104966|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104967|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104968|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104969|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104970|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104971|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104972|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104973|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104974|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104975|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104976|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
104977|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104978|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104979|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104980|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104981|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
104982|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
104983|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
104984|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
104985|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104986|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104987|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104988|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104989|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104990|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104991|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104992|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104993|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
104994|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
104995|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
104996|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
104997|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
104998|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
104999|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
105000|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
105001|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105002|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105003|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105004|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105005|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
105006|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
105035|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105007|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
105008|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
105009|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105010|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105011|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105012|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105013|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105014|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105016|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105017|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105018|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105019|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105020|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105021|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105022|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105023|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
105024|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
105025|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105026|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105027|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105028|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105029|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
105030|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
105031|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
105032|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
105033|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105034|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105036|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105037|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105038|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105039|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105040|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105041|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105042|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105043|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105044|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105045|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105046|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105047|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
105048|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
105049|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105050|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105051|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105052|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105053|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
105054|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
105055|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
105056|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
105057|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105058|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105059|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105060|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105061|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105062|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105063|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105064|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105065|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105066|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105067|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105068|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105069|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105070|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105071|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
105136|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105072|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
105073|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105074|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105075|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105076|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105077|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
105078|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
105079|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
105080|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
105081|NCT01763866|E24|Reported Event|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105082|NCT01763866|E23|Reported Event|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105083|NCT01763866|E22|Reported Event|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105084|NCT01763866|E21|Reported Event|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105085|NCT01763866|E20|Reported Event|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105086|NCT01763866|E19|Reported Event|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105087|NCT01763866|E18|Reported Event|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105088|NCT01763866|E17|Reported Event|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105089|NCT01763866|E16|Reported Event|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
105090|NCT01763866|E15|Reported Event|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
105091|NCT01763866|E14|Reported Event|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
105092|NCT01763866|E13|Reported Event|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
105093|NCT01763866|E12|Reported Event|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105094|NCT01763866|E11|Reported Event|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105095|NCT01763866|E10|Reported Event|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
105096|NCT01763866|E9|Reported Event|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
105097|NCT01763866|E8|Reported Event|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105098|NCT01763866|E7|Reported Event|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105176|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105099|NCT01763866|E6|Reported Event|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
105100|NCT01763866|E5|Reported Event|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
105101|NCT01763866|E4|Reported Event|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
105102|NCT01763866|E3|Reported Event|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
105103|NCT01763866|E2|Reported Event|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
105104|NCT01763866|E1|Reported Event|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
105105|NCT01763827|B7|Baseline|Total|Total of all reporting groups
105106|NCT01763827|B6|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105107|NCT01763827|B5|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105108|NCT01763827|B4|Baseline|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105109|NCT01763827|B3|Baseline|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105110|NCT01763827|B2|Baseline|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105111|NCT01763827|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105112|NCT01763827|P6|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105113|NCT01763827|P5|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105114|NCT01763827|P4|Participant Flow|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105115|NCT01763827|P3|Participant Flow|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105116|NCT01763827|P2|Participant Flow|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105117|NCT01763827|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105118|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105119|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105120|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105121|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105122|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105123|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105124|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105126|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105127|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105128|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105129|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105130|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105131|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105132|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105133|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105134|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105135|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
106019|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
105137|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105138|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105139|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105140|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105141|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105142|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105143|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105144|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105145|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105146|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105147|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105148|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105149|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105150|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105151|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105152|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105153|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105154|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105155|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105156|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105157|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105158|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105159|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105160|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105161|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105162|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105163|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105164|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105780|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105165|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105166|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105167|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105168|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105169|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105170|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105171|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105172|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105173|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105174|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105175|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105177|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105178|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105179|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105180|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105181|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105182|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105183|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105184|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105185|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105186|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105187|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105188|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105189|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105190|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105191|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105192|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105193|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105194|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105195|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105196|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105197|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105198|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105199|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105200|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105201|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105202|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105203|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105204|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105205|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105206|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105207|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105208|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105209|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105210|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105211|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105212|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105213|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105214|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105215|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105217|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105218|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105219|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105220|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105221|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105222|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105223|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105224|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105225|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105226|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105227|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105228|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105229|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105230|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105231|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105232|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105233|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105234|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105235|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105236|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105237|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105238|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105239|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105240|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105241|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105242|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105781|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105243|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105244|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105245|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105246|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105247|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105248|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
105249|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105250|NCT01763827|E6|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
105251|NCT01763827|E5|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
105252|NCT01763827|E4|Reported Event|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
105253|NCT01763827|E3|Reported Event|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
105254|NCT01763827|E2|Reported Event|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
106688|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
105255|NCT01763827|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
105256|NCT01763645|B3|Baseline|Total|Total of all reporting groups
105257|NCT01763645|B2|Baseline|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.
Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1."
105258|NCT01763645|B1|Baseline|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105259|NCT01763645|P2|Participant Flow|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105260|NCT01763645|P1|Participant Flow|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105261|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105262|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105263|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105264|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105265|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105288|NCT01763047|P2|Participant Flow|Lotrafilcon B/ Etafilcon A|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
105481|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Azilsartan: Azilsartan 20mg/day"
105266|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105267|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105268|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105269|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105300|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
105301|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
105270|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105271|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105272|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105273|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.
Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1."
105274|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
105275|NCT01763645|E2|Reported Event|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.
Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug."
105276|NCT01763645|E1|Reported Event|BCD-021 (CISC BIOCAD)|"In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug."
105277|NCT01763567|B1|Baseline|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
105278|NCT01763567|P1|Participant Flow|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
105279|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
105280|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
105281|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
105282|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
105283|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
105284|NCT01763567|E1|Reported Event|Observation Arm|To assess safety and device performance for the Hospital Glucose Managment system
105285|NCT01763047|B3|Baseline|Total|Total of all reporting groups
105286|NCT01763047|B2|Baseline|Lotrafilcon B/ Etafilcon A|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B and then received the etafilcon A.
105287|NCT01763047|B1|Baseline|Etafilcon A/ Lotrafilcon B|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A and then received the lotrafilcon B.
105289|NCT01763047|P1|Participant Flow|Etafilcon A/ Lotrafilcon B|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A lens and then received the lotrafilcon B lens.
105290|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
105291|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
105292|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
105293|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
105294|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
105295|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
105296|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.
105297|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.
105298|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B during either the first or second period of the study.
105299|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
105302|NCT01763047|E2|Reported Event|Control (Lotrafilcon B)|Subjects that were dispensed the Control lens (lotrafilcon B) during either the first or second period of the study.
105303|NCT01763047|E1|Reported Event|Test (Etafilcon A)|Subjects that were dispensed the Test lens (etafilcon A) during either the first or second period of the study.
105304|NCT01762982|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline parameters.
105305|NCT01762982|P1|Participant Flow|Overall|This was a 4-way split-plot clinical study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 milliliters (mL) of 0.13% Benazalkonium chloride solution), one positive control [Sodium lauryl sulphate (SLS); 0.03 mL of 0.3% weight by weight (w/w) SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% weight by volume (w/v) normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.
105306|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105307|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105308|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105309|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105310|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
105311|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105312|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105313|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105314|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
105315|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105316|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105317|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105318|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105319|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105320|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
105321|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105322|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105323|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
105334|NCT01762800|B1|Baseline|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105482|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Amlodipine: Amlodipine 5mg/day"
105324|NCT01762982|E1|Reported Event|Overall Study|"This was a 4-way split-plot study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 mL of 0.13% Benazalkonium chloride solution), one positive control [SLS; 0.03 mL of 0.3% w/w SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% w/v normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.
All randomized participants exposed to at least one of the study treatments were evaluated for safety."
105325|NCT01762904|B1|Baseline|Whole Group of 135 Units of Measurement|"The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.
The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.
Interventions:
Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls
Other: Preparing skin's areas to be tested with two antiseptics and two controls"
105338|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105450|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105326|NCT01762904|P1|Participant Flow|Whole Group of 135 Units of Measurement|"The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.
The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.
Interventions:
Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls
Other: Preparing skin's areas to be tested with two antiseptics and two controls"
105327|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. Were prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
105328|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test two controls: Deionized water redistilled and Scrub the skin without prior application of any substance was tested.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled and Scrub the skin without prior application of any substance was tested.
Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
105329|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test 1% triclosan in 70% isopropyl alcohol.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
105330|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test 2% chlorhexidine in 70% isopropyl alcohol.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
105331|NCT01762904|E1|Reported Event|Whole Group of 135 Units of Measurement|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. Were prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
105332|NCT01762800|B3|Baseline|Total|Total of all reporting groups
105333|NCT01762800|B2|Baseline|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105483|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Azilsartan: Azilsartan 20mg/day"
105335|NCT01762800|P2|Participant Flow|SAL/FLU 50/250 µg BID|Participants received 50/250 µg salmeterol xinafoate (SAL)/fluticasone propionate (FLU) BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105336|NCT01762800|P1|Participant Flow|TIO 18 µg QD|Participants received 18 micrograms (µg) tiotropium bromide (TIO) once daily (QD) via HandiHaler inhaler and placebo twice daily (BID) via dry powder inhaler (DPI), during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105337|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105372|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105339|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105340|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105341|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105342|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105343|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105344|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105345|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105346|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105347|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105348|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105349|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105350|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105351|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105352|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105353|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105354|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105355|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105448|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105356|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105357|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105358|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105359|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105360|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105361|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105362|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105363|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105364|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105365|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105366|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105367|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105368|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105369|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105370|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105371|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105548|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
105549|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
105373|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105374|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105375|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105376|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105377|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105378|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105379|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105380|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105381|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105382|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105383|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105384|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105440|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105385|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105386|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105387|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105449|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105388|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105389|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105390|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105391|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105392|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105393|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105394|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105395|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105396|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105397|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105398|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105399|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105400|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105401|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105402|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
105441|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105403|NCT01762800|E4|Reported Event|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105404|NCT01762800|E3|Reported Event|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
105405|NCT01762800|E2|Reported Event|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
105550|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
105406|NCT01762800|E1|Reported Event|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
105407|NCT01762761|B3|Baseline|Total|Total of all reporting groups
105408|NCT01762761|B2|Baseline|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105409|NCT01762761|B1|Baseline|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105410|NCT01762761|P2|Participant Flow|Eltrombopag|Participants initially received eltrombopag 25 milligrams (mg) QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105411|NCT01762761|P1|Participant Flow|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105412|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
105413|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
105414|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
105415|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
105416|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
105417|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
105442|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105484|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Amlodipine: Amlodipine 5mg/day"
105418|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
105419|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
105551|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
105420|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
105421|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
105422|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105423|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105424|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105425|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105426|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105427|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105428|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105429|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105430|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105431|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105432|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105433|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105434|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105435|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105436|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105437|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105438|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105439|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105480|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Amlodipine: Amlodipine 5mg/day"
105443|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105444|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105445|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105446|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105447|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105552|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
105451|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105452|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105453|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105454|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105455|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105456|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105457|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105458|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105459|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105460|NCT01762761|E2|Reported Event|Eltrombopag|Participants initially received eltrombopag 25 milligrams (mg) QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105461|NCT01762761|E1|Reported Event|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
105462|NCT01762722|B3|Baseline|Total|Total of all reporting groups
105463|NCT01762722|B2|Baseline|Validation|Group of subjects in whom the final algorithm is tested.
105464|NCT01762722|B1|Baseline|Calibration|Initial group of subjects on whom the test algorithm is developed.
105465|NCT01762722|P2|Participant Flow|Validation|Group of subjects in whom the final algorithm is tested.
105466|NCT01762722|P1|Participant Flow|Calibration|Initial group of subjects on whom the test algorithm is developed.
105467|NCT01762722|O2|Outcome|Validation|Group of subjects in whom the final algorithm is tested.
105468|NCT01762722|O1|Outcome|Calibration|Initial group of subjects on whom the test algorithm is developed.
105469|NCT01762722|E2|Reported Event|Validation|Group of subjects in whom the final algorithm is tested.
105470|NCT01762722|E1|Reported Event|Calibration|Initial group of subjects on whom the test algorithm is developed.
105471|NCT01762501|B3|Baseline|Total|Total of all reporting groups
105472|NCT01762501|B2|Baseline|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Amlodipine: Amlodipine 5mg/day"
105473|NCT01762501|B1|Baseline|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Azilsartan: Azilsartan 20mg/day"
105474|NCT01762501|P2|Participant Flow|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Amlodipine: Amlodipine 5mg/day"
105475|NCT01762501|P1|Participant Flow|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Azilsartan: Azilsartan 20mg/day"
105476|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Amlodipine: Amlodipine 5mg/day"
105477|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Azilsartan: Azilsartan 20mg/day"
105478|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Amlodipine: Amlodipine 5mg/day"
105479|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Azilsartan: Azilsartan 20mg/day"
105485|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Azilsartan: Azilsartan 20mg/day"
105486|NCT01762501|E2|Reported Event|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Amlodipine: Amlodipine 5mg/day"
105487|NCT01762501|E1|Reported Event|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Azilsartan: Azilsartan 20mg/day"
105488|NCT01762345|B1|Baseline|Pessary Device|pessary (disposable intra-vaginal device)
105489|NCT01762345|P1|Participant Flow|Pessary Device|pessary (disposable intra-vaginal device)
105490|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
105491|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
105492|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
105493|NCT01762345|O1|Outcome|Pessary Device|"pessary (disposable intra-vaginal device)
pessary (disposable intra-vaginal device): pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble"
105494|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
105495|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
105496|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
105497|NCT01762345|E1|Reported Event|Pessary Device|pessary (disposable intra-vaginal device)
105498|NCT01762059|B1|Baseline|All Participants|
105553|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
105554|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
105555|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
105499|NCT01762059|P1|Participant Flow|All Participants: Bi-hormonal Bionic Pancreas and Usual Care|"Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise.
After the first experimental period, there was a two-day washout period followed by the second experimental period.
Usual care for 5 days (insulin pump therapy according to usual practice), volunteers will sleep at home and maintain their usual schedule during the day, there will be no restrictions on diet or exercise, they will wear a blinded CGM
Usual care"
105500|NCT01762059|O2|Outcome|Usual Care|
105501|NCT01762059|O1|Outcome|Bionic Pancreas|
105502|NCT01762059|O2|Outcome|Usual Care|
105503|NCT01762059|O1|Outcome|Bionic Pancreas|
105504|NCT01762059|O1|Outcome|All Participants|
105505|NCT01762059|O2|Outcome|Usual Care|
105506|NCT01762059|O1|Outcome|Bionic Pancreas|
105507|NCT01762059|O1|Outcome|All Participants|
105508|NCT01762059|O1|Outcome|All Participants|
105509|NCT01762059|O1|Outcome|All Participants|
105510|NCT01762059|O1|Outcome|All Participants|
105511|NCT01762059|O1|Outcome|All Participants|
105512|NCT01762059|O1|Outcome|Bionic Pancreas|Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .
105513|NCT01762059|O1|Outcome|All Participants|
105514|NCT01762059|O1|Outcome|All Participants|
105515|NCT01762059|O1|Outcome|All Participants|
105516|NCT01762059|O1|Outcome|All Participants|
105517|NCT01762059|O1|Outcome|Bionic Pancreas|
105518|NCT01762059|O1|Outcome|All Participants|
105519|NCT01762059|O1|Outcome|All Participants|
105520|NCT01762059|O1|Outcome|All Participants: Bi-hormonal Bionic Pancreas and Usual Care|"Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise.
After the first experimental period, there was a two-day washout period followed by the second experimental period.
Usual care for 5 days (insulin pump therapy according to usual practice), volunteers will sleep at home and maintain their usual schedule during the day, there will be no restrictions on diet or exercise, they will wear a blinded CGM
Usual care"
105521|NCT01762059|O1|Outcome|Bi-homonal Bionic Pancreas|"Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise.
Bi-homonal Bionic Pancreas: A computer algorithm will automatically deliver insulin lispro and glucagon based on the signal from a minimally invasive continuous glucose monitor."
105522|NCT01762059|O1|Outcome|Bionic Pancreas|
105523|NCT01762059|O1|Outcome|Bionic Pancreas|Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .
105524|NCT01762059|E1|Reported Event|Bionic Pancreas (Closed Loop)|
105525|NCT01761747|B1|Baseline|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily
ponatinib"
105526|NCT01761747|P1|Participant Flow|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily
ponatinib"
105527|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily
ponatinib"
105528|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily
ponatinib"
105529|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily
ponatinib"
105530|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily
ponatinib"
105531|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily
ponatinib"
105532|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily
ponatinib"
105533|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily
ponatinib"
105536|NCT01761565|B1|Baseline|One Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15 mcg|"Arm 1/Period 1: Single dose of SUF NT 15 mcg
Single dose of SUF NT 15 mcg
Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg
40 consecutive doses of SUF NT 15 mcg"
105537|NCT01761565|P1|Participant Flow|Single Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15mcg|"Arm 1/Period 1: Single dose of SUF NT 15 mcg
Subjects received oral naltrexone 50 mg approximately 14 and 2 hours before and 10 hours after the SUF NT dosing
Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg
Subjects received oral naltrexone 50 mg approximately 2 hours before and 10, 22, and 34 hours after the first dose of SUF NT in Period 2."
105538|NCT01761565|O2|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
105539|NCT01761565|O1|Outcome|Single Dose of SUF NT 15 mcg|Arm 1/Period 1: Single dose of SUF NT 15 mcg
105540|NCT01761565|O1|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
105541|NCT01761565|O2|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
105542|NCT01761565|O1|Outcome|Single Dose of SUF NT 15 mcg|
105543|NCT01761565|E2|Reported Event|40 Consecutive Doses of SUF NT 15 mcg|
105544|NCT01761565|E1|Reported Event|Single Dose of SUF NT 15 mcg|
105545|NCT01761279|B1|Baseline|HDWL + I-Scan|High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
105546|NCT01761279|P1|Participant Flow|HDWL and i-Scan Assessment|High Definition White Light Endoscopy.
105547|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
105559|NCT01761175|B2|Baseline|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105560|NCT01761175|B1|Baseline|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
105561|NCT01761175|P2|Participant Flow|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105562|NCT01761175|P1|Participant Flow|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
105563|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105564|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected looking for a crescent shape distribution around the artery."
105565|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105566|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected looking for a crescent shape distribution around the artery."
105567|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105568|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected looking for a crescent shape distribution around the artery."
105569|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105782|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105570|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
105571|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105572|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
105573|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105574|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
105575|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105576|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
105577|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105578|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
105579|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105580|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
105581|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105582|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
105583|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105584|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected looking for a crescent shape distribution around the artery."
105585|NCT01761175|O2|Outcome|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105586|NCT01761175|O1|Outcome|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
105587|NCT01761175|E2|Reported Event|Ultrasound-guided Axillary Block|"Ultrasound-guided double injection axillary block
Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve."
105783|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105588|NCT01761175|E1|Reported Event|Ultrasound-guided Infraclavicular Block|"Ultrasound-guided single injection infraclavicular block
Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery."
105589|NCT01761162|B1|Baseline|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
105590|NCT01761162|P1|Participant Flow|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
105591|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
105592|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
105593|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
105594|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
105595|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
105596|NCT01761162|E1|Reported Event|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
105597|NCT01761019|B1|Baseline|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Taclonex Topical Suspension: topical medication for psoriasis"
105598|NCT01761019|P1|Participant Flow|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Taclonex Topical Suspension: topical medication for psoriasis"
105599|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Taclonex Topical Suspension: topical medication for psoriasis"
105600|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Taclonex Topical Suspension: topical medication for psoriasis"
105601|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Taclonex Topical Suspension: topical medication for psoriasis"
105602|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Taclonex Topical Suspension: topical medication for psoriasis"
105603|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Taclonex Topical Suspension: topical medication for psoriasis"
105604|NCT01761019|E1|Reported Event|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Taclonex Topical Suspension: topical medication for psoriasis"
105605|NCT01760993|B1|Baseline|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105606|NCT01760993|P1|Participant Flow|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105607|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105608|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105609|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105610|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105611|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105612|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105613|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105614|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105615|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105616|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105617|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105618|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105619|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105620|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105621|NCT01760993|E1|Reported Event|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
105622|NCT01760941|B1|Baseline|Radiotherapy|"Single fraction radiotherapy
Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.
planning."
105623|NCT01760941|P1|Participant Flow|Radiotherapy|"Single fraction radiotherapy
Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.
planning."
105624|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy
Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.
planning."
105625|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy
Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.
planning."
105626|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy
Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.
planning."
105627|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy
Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.
planning."
105628|NCT01760941|E1|Reported Event|Radiotherapy|"Single fraction radiotherapy
Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.
planning."
105629|NCT01760889|B4|Baseline|Total|Total of all reporting groups
105630|NCT01760889|B3|Baseline|Placebo|Placebo: One capsule a day for 26 weeks
105631|NCT01760889|B2|Baseline|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105717|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
105632|NCT01760889|B1|Baseline|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105633|NCT01760889|P3|Participant Flow|Placebo|Placebo: One capsule a day for 26 weeks
105634|NCT01760889|P2|Participant Flow|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105635|NCT01760889|P1|Participant Flow|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105636|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105637|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105638|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105639|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105640|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105641|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105642|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105643|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105644|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105646|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105647|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105648|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105649|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105650|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105651|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105671|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105652|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105653|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105654|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105655|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105656|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105657|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105658|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105659|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105660|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105661|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105662|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105663|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105664|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105784|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105785|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105665|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105666|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105667|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105668|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105669|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105670|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105672|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105673|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105674|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105675|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
105676|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105677|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105678|NCT01760889|E3|Reported Event|Placebo|Placebo: One capsule a day for 26 weeks
105679|NCT01760889|E2|Reported Event|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once daily for 1 week; then
120 mg capsule once-daily for 1 week, then,
140 mg capsule once-daily for 2 weeks, then
160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
105680|NCT01760889|E1|Reported Event|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,
40 mg capsule once-daily for 1 week; then
80 mg capsule once-daily for 4 weeks; then,
100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
105681|NCT01760876|B1|Baseline|Biofreedom Stent|Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
105682|NCT01760876|P1|Participant Flow|Biofreedom Stent|Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
105683|NCT01760876|O1|Outcome|Biofreedom Stent|The healing profile (curve) in terms of percentage strut coverage of the BioFreedom Stent increased from a median of 85.77%, 86.95%, 88.56%, 96.79%, and 97.14% in the first 5 months, to 99.55% at 9 months.
105786|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105787|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105684|NCT01760876|E1|Reported Event|Biofreedom Stent|The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
105685|NCT01760785|B3|Baseline|Total|Total of all reporting groups
105686|NCT01760785|B2|Baseline|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
105687|NCT01760785|B1|Baseline|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
105688|NCT01760785|P2|Participant Flow|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
105715|NCT01759511|B1|Baseline|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
105812|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105689|NCT01760785|P1|Participant Flow|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
105690|NCT01760785|O2|Outcome|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
105691|NCT01760785|O1|Outcome|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
105692|NCT01760785|E2|Reported Event|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
105693|NCT01760785|E1|Reported Event|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
105694|NCT01760304|B3|Baseline|Total|Total of all reporting groups
105695|NCT01760304|B2|Baseline|Placebo First, Then Budesonide/Formoterol|"Subjects received in a blinded fashion placebo 2 inhalation then Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5)
Subject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Placebo on visit 1 then Budesonide/formoterol (B/F) 160/4.5 msg per activation on visit 2 (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105696|NCT01760304|B1|Baseline|Budesonide / Formoterol First , Then Placebo|"Subjects received in a blinded fashion Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5) then placebo 2 inhalations Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.
Subject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105697|NCT01760304|P2|Participant Flow|Placebo Then Budesonide/Formoterol|"Every patient in this arm received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® )
Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105698|NCT01760304|P1|Participant Flow|Budesonide / Formoterol , Then Placebo|"This is a crossover study, where every patient signed to this arm received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) 160/4.5 mcg (2 inhalations) then placebo
Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.
Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105699|NCT01760304|O2|Outcome|Placebo|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo
Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105700|NCT01760304|O1|Outcome|Budesonide / Formoterol|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo
Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.
Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105716|NCT01759511|P1|Participant Flow|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
105813|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105701|NCT01760304|O2|Outcome|Placebo|"In this arm patients will received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study)
Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105702|NCT01760304|O1|Outcome|Budesonide / Formoterol|"In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)
Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.
Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105703|NCT01760304|O2|Outcome|Placebo|"In this arm patients received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study).
Placebo: On visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105704|NCT01760304|O1|Outcome|Budesonide / Formoterol|"In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)
Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.
Subject who met inclusion criteria will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105705|NCT01760304|E2|Reported Event|Placebo|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo
Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105706|NCT01760304|E1|Reported Event|Budesonide / Formoterol|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo
Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.
Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).
After 45 minutes , the above measurements will be repeated."
105707|NCT01759602|B1|Baseline|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.
C1-esterase inhibitor (Cinryze)"
105708|NCT01759602|P1|Participant Flow|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.
C1-esterase inhibitor (Cinryze)"
105709|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.
C1-esterase inhibitor (Cinryze)"
105710|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.
C1-esterase inhibitor (Cinryze)"
105788|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105789|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105711|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.
C1-esterase inhibitor (Cinryze)"
105712|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.
C1-esterase inhibitor (Cinryze)"
105713|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.
C1-esterase inhibitor (Cinryze)"
105714|NCT01759602|E1|Reported Event|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.
C1-esterase inhibitor (Cinryze)"
105718|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
105719|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
105720|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
105721|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
105722|NCT01759511|E1|Reported Event|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
105723|NCT01759420|B1|Baseline|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.
Ondansetron: 4mg of intravenous ondansetron"
105724|NCT01759420|P1|Participant Flow|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.
Ondansetron: 4mg of intravenous ondansetron"
105725|NCT01759420|O1|Outcome|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.
Ondansetron: 4mg of intravenous ondansetron"
105726|NCT01759420|O1|Outcome|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.
Ondansetron: 4mg of intravenous ondansetron"
105727|NCT01759420|E1|Reported Event|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.
Ondansetron: 4mg of intravenous ondansetron"
105728|NCT01759381|B3|Baseline|Total|Total of all reporting groups
105729|NCT01759381|B2|Baseline|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.
Negative pressure wound therapy (NPWT)"
105730|NCT01759381|B1|Baseline|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
105731|NCT01759381|P2|Participant Flow|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.
Negative pressure wound therapy (NPWT)"
105732|NCT01759381|P1|Participant Flow|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
105733|NCT01759381|O2|Outcome|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.
Negative pressure wound therapy (NPWT)"
105734|NCT01759381|O1|Outcome|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
105735|NCT01759381|E2|Reported Event|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.
Negative pressure wound therapy (NPWT)"
105736|NCT01759381|E1|Reported Event|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
105737|NCT01759368|B3|Baseline|Total|Total of all reporting groups
105790|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105791|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105792|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105793|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105794|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105738|NCT01759368|B2|Baseline|Control Group|Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of HF patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients' visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient's own activity.
105739|NCT01759368|B1|Baseline|Telemonitoring-assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not mak
105740|NCT01759368|P2|Participant Flow|Control Group|Control group received multidisciplinary care that was standard.
105814|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105815|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105816|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105817|NCT01759290|E1|Reported Event|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105818|NCT01759264|B1|Baseline|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105741|NCT01759368|P1|Participant Flow|Telemonitoring Assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
105742|NCT01759368|O2|Outcome|Control Group|Control group received usual care
105743|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.
Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
105744|NCT01759368|O2|Outcome|Control Group|Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of HF patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients’ visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient’s own activity
105745|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
105746|NCT01759368|O2|Outcome|Control Group|Control group received usual care
105747|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.
Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
105748|NCT01759368|O2|Outcome|Control Group|Control group received usual care
105795|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105796|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105797|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105798|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105799|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105749|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.
Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
105750|NCT01759368|O2|Outcome|Control Group|Control group received usual care
105751|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.
Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
105752|NCT01759368|O2|Outcome|Control Group|Control group received usual care
105928|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
105753|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.
Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
105754|NCT01759368|O2|Outcome|Control Group|Control group received usual care
105755|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.
Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
105756|NCT01759368|E2|Reported Event|Control Group|Control group received usual care
105757|NCT01759368|E1|Reported Event|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.
Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
105758|NCT01759290|B1|Baseline|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105759|NCT01759290|P1|Participant Flow|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105760|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105761|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105762|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105763|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105764|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105765|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105766|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105767|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105768|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105769|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105770|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105771|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105772|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105773|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105774|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105775|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105776|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105777|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105778|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105800|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105801|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105802|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105803|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105804|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105805|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105806|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105807|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105808|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105809|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105810|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105811|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
105819|NCT01759264|P1|Participant Flow|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105820|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105821|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105822|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105823|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105824|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105825|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105826|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105827|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105828|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105829|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105830|NCT01759264|E1|Reported Event|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
105831|NCT01759251|B1|Baseline|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
105832|NCT01759251|P1|Participant Flow|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
105833|NCT01759251|O1|Outcome|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
105834|NCT01759251|E1|Reported Event|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
105835|NCT01759160|B3|Baseline|Total|Total of all reporting groups
105836|NCT01759160|B2|Baseline|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
105837|NCT01759160|B1|Baseline|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
105838|NCT01759160|P2|Participant Flow|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
105839|NCT01759160|P1|Participant Flow|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
105840|NCT01759160|O2|Outcome|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
105841|NCT01759160|O1|Outcome|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
105842|NCT01759160|E2|Reported Event|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
105843|NCT01759160|E1|Reported Event|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
105844|NCT01758900|B3|Baseline|Total|Total of all reporting groups
105845|NCT01758900|B2|Baseline|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm
Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105846|NCT01758900|B1|Baseline|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator
CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105847|NCT01758900|P2|Participant Flow|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm
Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105848|NCT01758900|P1|Participant Flow|CO2(Carbon Dioxide) Insufflation Regulator|"Device: CO2 insufflation regulator
CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE(single-balloon enteroscopy)."
105849|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm
Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105850|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator
CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105851|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm
Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105852|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator
CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105853|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm
Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105854|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator
CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105855|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm
Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105856|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator
CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105857|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm
Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105858|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator
CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105859|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm
Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105860|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator
CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105861|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm
Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105862|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator
CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105863|NCT01758900|E2|Reported Event|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm
Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105864|NCT01758900|E1|Reported Event|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator
CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
105865|NCT01758289|B1|Baseline|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105866|NCT01758289|P1|Participant Flow|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol intravenous (IV) per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105867|NCT01758289|O2|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105868|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105869|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105870|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105871|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105872|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105873|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105874|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105875|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105876|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105877|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105878|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105879|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105880|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105881|NCT01758289|E1|Reported Event|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
105882|NCT01757964|B3|Baseline|Total|Total of all reporting groups
105883|NCT01757964|B2|Baseline|Bacteriotherapy: Ulcerative Colitis|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
105884|NCT01757964|B1|Baseline|Bacteriotherapy: Crohn's Disease|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
105885|NCT01757964|P2|Participant Flow|Bacteriotherapy: Ulcerative Colitis|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
105961|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
105886|NCT01757964|P1|Participant Flow|Bacteriotherapy: Crohn's Disease|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
105887|NCT01757964|O1|Outcome|Bacteriotherapy|"Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.
Bacteriotherapy"
105888|NCT01757964|E1|Reported Event|Bacteriotherapy|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
105889|NCT01757847|B3|Baseline|Total|Total of all reporting groups
105890|NCT01757847|B2|Baseline|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
105929|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
105930|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
105891|NCT01757847|B1|Baseline|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy
105892|NCT01757847|P2|Participant Flow|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
105893|NCT01757847|P1|Participant Flow|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
105894|NCT01757847|O2|Outcome|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
105895|NCT01757847|O1|Outcome|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
105896|NCT01757847|O2|Outcome|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
105897|NCT01757847|O1|Outcome|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
105898|NCT01757847|E2|Reported Event|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
105899|NCT01757847|E1|Reported Event|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
105900|NCT01757704|B3|Baseline|Total|Total of all reporting groups
105901|NCT01757704|B2|Baseline|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
105902|NCT01757704|B1|Baseline|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
105903|NCT01757704|P2|Participant Flow|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
105904|NCT01757704|P1|Participant Flow|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
105905|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
105962|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
105963|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
105964|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
106080|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
105906|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
105907|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
105931|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
105932|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
105933|NCT01757691|E2|Reported Event|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
105908|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
105909|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
105910|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
105911|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
105912|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
105965|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
106081|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
105913|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
105914|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
105915|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
105916|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
105917|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
105918|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
105919|NCT01757704|E2|Reported Event|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
105966|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
106335|NCT01754766|P3|Participant Flow|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
105920|NCT01757704|E1|Reported Event|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.
Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
105921|NCT01757691|B1|Baseline|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
105922|NCT01757691|P2|Participant Flow|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
105923|NCT01757691|P1|Participant Flow|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
105924|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
105925|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
105926|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
105927|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
105936|NCT01757561|B4|Baseline|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%
sevoflurane: use inhalation anesthesia with sevoflurane"
105937|NCT01757561|B3|Baseline|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%
sevoflurane: use inhalation anesthesia with sevoflurane"
105938|NCT01757561|B2|Baseline|Propofol-Normal|"patients with preoperative SjvO2≥55%
propofol: use total intravenous anesthesia with propofol"
105939|NCT01757561|B1|Baseline|Propofol-Abnormal|"patients with preoperative SjvO2<55%
propofol: use total intravenous anesthesia with propofol"
105940|NCT01757561|P4|Participant Flow|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%
sevoflurane: use inhalation anesthesia with sevoflurane"
105941|NCT01757561|P3|Participant Flow|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%
sevoflurane: use inhalation anesthesia with sevoflurane"
105942|NCT01757561|P2|Participant Flow|Propofol-Normal|"patients with preoperative SjvO2≥55%
propofol: use total intravenous anesthesia with propofol"
105943|NCT01757561|P1|Participant Flow|Propofol-Abnormal|"patients with preoperative SjvO2<55%
propofol: use total intravenous anesthesia with propofol"
105944|NCT01757561|O4|Outcome|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%
sevoflurane: use inhalation anesthesia with sevoflurane"
105945|NCT01757561|O3|Outcome|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%
sevoflurane: use inhalation anesthesia with sevoflurane"
105946|NCT01757561|O2|Outcome|Propofol-Normal|"patients with preoperative SjvO2≥55%
propofol: use total intravenous anesthesia with propofol"
105947|NCT01757561|O1|Outcome|Propofol-Abnormal|"patients with preoperative SjvO2<55%
propofol: use total intravenous anesthesia with propofol"
105948|NCT01757561|O4|Outcome|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%
sevoflurane: use inhalation anesthesia with sevoflurane"
105949|NCT01757561|O3|Outcome|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%
sevoflurane: use inhalation anesthesia with sevoflurane"
105950|NCT01757561|O2|Outcome|Propofol-Normal|"patients with preoperative SjvO2≥55%
propofol: use total intravenous anesthesia with propofol"
105951|NCT01757561|O1|Outcome|Propofol-Abnormal|"patients with preoperative SjvO2<55%
propofol: use total intravenous anesthesia with propofol"
105952|NCT01757561|E4|Reported Event|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%
sevoflurane: use inhalation anesthesia with sevoflurane"
105953|NCT01757561|E3|Reported Event|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%
sevoflurane: use inhalation anesthesia with sevoflurane"
105954|NCT01757561|E2|Reported Event|Propofol-Normal|"patients with preoperative SjvO2≥55%
propofol: use total intravenous anesthesia with propofol"
105955|NCT01757561|E1|Reported Event|Propofol-Abnormal|"patients with preoperative SjvO2<55%
propofol: use total intravenous anesthesia with propofol"
105956|NCT01757405|B3|Baseline|Total|Total of all reporting groups
105957|NCT01757405|B2|Baseline|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
105958|NCT01757405|B1|Baseline|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
105959|NCT01757405|P2|Participant Flow|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
105960|NCT01757405|P1|Participant Flow|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
105967|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
105968|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
105969|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
105970|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
105971|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
105972|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
105973|NCT01757405|E2|Reported Event|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
105974|NCT01757405|E1|Reported Event|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) every 3 hours as on-demand intravenous bolus infusions.
105975|NCT01757275|B3|Baseline|Total|Total of all reporting groups
105976|NCT01757275|B2|Baseline|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105977|NCT01757275|B1|Baseline|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105978|NCT01757275|P2|Participant Flow|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105979|NCT01757275|P1|Participant Flow|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105980|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105981|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105982|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105983|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105984|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105985|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105986|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105987|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105988|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105989|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105990|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105991|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105992|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105993|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105994|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105995|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105996|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105997|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105998|NCT01757275|E2|Reported Event|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
105999|NCT01757275|E1|Reported Event|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
106000|NCT01757184|B3|Baseline|Total|Total of all reporting groups
106001|NCT01757184|B2|Baseline|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
106002|NCT01757184|B1|Baseline|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
106003|NCT01757184|P2|Participant Flow|Double-Blind Placebo Followed by Open-Label SA|Double-blind Period: IV infusions of placebo administered once every other week (qow); Open-Label Period: IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered qow. In the event of disease progression (based on protocol-defined criteria), subjects could be considered for a dose increase to 3 mg/kg qow during the open-label period.
106004|NCT01757184|P1|Participant Flow|Double-blind SA, Followed by Open-Label SA|Double-blind Period: IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow); Open-Label Period: IV infusions of SA at a dose of 1 mg/kg administered qow. In the event of disease progression (based on protocol-defined criteria), subjects could be considered for a dose increase to 3 mg/kg qow during the open-label period.
106005|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
106006|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
106007|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
106008|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
106009|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
106010|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
106011|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
106012|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
106013|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
106014|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
106015|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
106016|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
106017|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
106018|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
106020|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
106021|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
106022|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
106023|NCT01757184|E2|Reported Event|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
106024|NCT01757184|E1|Reported Event|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
106025|NCT01756976|B3|Baseline|Total|Total of all reporting groups
106026|NCT01756976|B2|Baseline|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
106027|NCT01756976|B1|Baseline|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
106028|NCT01756976|P2|Participant Flow|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
106029|NCT01756976|P1|Participant Flow|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
106030|NCT01756976|O2|Outcome|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
106031|NCT01756976|O1|Outcome|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
106032|NCT01756976|E2|Reported Event|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
106033|NCT01756976|E1|Reported Event|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
106034|NCT01756586|B3|Baseline|Total|Total of all reporting groups
106035|NCT01756586|B2|Baseline|Experimental|"Bupivacaine with Dexamethasone
Dexamethasone
Bupivacaine: Control"
106036|NCT01756586|B1|Baseline|Control|"Plain bupivacaine
Bupivacaine: Control"
106037|NCT01756586|P2|Participant Flow|Experimental|"Bupivacaine with Dexamethasone
Dexamethasone
Bupivacaine: Control"
106038|NCT01756586|P1|Participant Flow|Control|"Plain bupivacaine
Bupivacaine: Control"
106039|NCT01756586|O2|Outcome|Experimental|"Bupivacaine with Dexamethasone
Dexamethasone
Bupivacaine: Control"
106040|NCT01756586|O1|Outcome|Control|"Plain bupivacaine
Bupivacaine: Control"
106041|NCT01756586|E2|Reported Event|Experimental|"Bupivacaine with Dexamethasone
Dexamethasone
Bupivacaine: Control"
106042|NCT01756586|E1|Reported Event|Control|"Plain bupivacaine
Bupivacaine: Control"
106043|NCT01756391|B1|Baseline|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
106044|NCT01756391|P1|Participant Flow|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
106045|NCT01756391|O1|Outcome|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
106046|NCT01756391|E1|Reported Event|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
106047|NCT01756300|B1|Baseline|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
106048|NCT01756300|P1|Participant Flow|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with severe resistant hypertension.
106049|NCT01756300|O4|Outcome|AT Twelve Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at Twelve month post-procedure
106050|NCT01756300|O3|Outcome|At Six Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at six month post-procedure
106051|NCT01756300|O2|Outcome|At Three Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at three month post-procedure
106052|NCT01756300|O1|Outcome|At One Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at one month post-procedure
106053|NCT01756300|O4|Outcome|At Twelve Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at twelve month post-procedure
106054|NCT01756300|O3|Outcome|At Six Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at six month post-procedure
106055|NCT01756300|O2|Outcome|At Three Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at three month post-procedure
106056|NCT01756300|O1|Outcome|At One Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at one month post-procedure
106057|NCT01756300|O4|Outcome|Blood Pressures at 12-Month Follow Up|ABPM blood pressures measured at 12-month post procedure
106058|NCT01756300|O3|Outcome|Blood Pressures at 6-Month Follow Up|ABPM blood pressures measured at 6-month post procedure
106059|NCT01756300|O2|Outcome|Blood Pressures at 3-Month Follow Up|ABPM blood pressures measured at 3-month post procedure
106060|NCT01756300|O1|Outcome|Blood Pressures at Baseline|ABPM blood pressures measured at Baseline
106061|NCT01756300|O5|Outcome|Blood Pressures at 12-Month Follow Up|Office blood pressures measured at 12-month post procedure
106062|NCT01756300|O4|Outcome|Blood Pressures at 6-Month Follow Up|Office blood pressures measured at 6-month post procedure
106063|NCT01756300|O3|Outcome|Blood Pressures at 3-Month Follow Up|Office blood pressures measured at 3-month post procedure
106064|NCT01756300|O2|Outcome|Blood Pressures at 1-Month Follow Up|Office blood pressures measured at one month post-procedure
106065|NCT01756300|O1|Outcome|Blood Pressures at Baseline|Office blood pressures measured at Baseline
106147|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106066|NCT01756300|O1|Outcome|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
106067|NCT01756300|O1|Outcome|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
106068|NCT01756300|E1|Reported Event|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
106069|NCT01756274|B1|Baseline|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples. Baseline Characteristics for Participant Flow based on number of blood samples, not number of subjects.
106070|NCT01756274|P1|Participant Flow|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS.
106071|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
106072|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
106073|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
106074|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
106075|NCT01756274|E1|Reported Event|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory.
106076|NCT01756235|B1|Baseline|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106077|NCT01756235|P1|Participant Flow|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice
106078|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106079|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106336|NCT01754766|P2|Participant Flow|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
106082|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106083|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106084|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106085|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106086|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106087|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106088|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106089|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106090|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106091|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106092|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106093|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106094|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106095|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106096|NCT01756235|E1|Reported Event|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
106097|NCT01756157|B1|Baseline|Entire Study Population|Included participants who received 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks (Treatment A) first and 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks (Treatment B) first.
106098|NCT01756157|P2|Participant Flow|Treatment Sequence B/A|"Participants received Treatment B in Period 1 and Treatment A in Period 2; for 8 weeks each as a single 20 mL SC injection per dose. A washout period of at least 7 days and no more than 30 days was maintained between the last dose in Period 1 and the first dose in Period 2.
Treatment B: 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks.
Treatment A: 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks."
106099|NCT01756157|P1|Participant Flow|Treatment Sequence A/B|"Participants received Treatment A in Period 1 and Treatment B in Period 2; for 8 weeks each as a single 20 milliliter (mL) subcutaneous (SC) injection per dose. A washout period of at least 7 days and no more than 30 days was maintained between the last dose in Period 1 and the first dose in Period 2.
Treatment A: 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks.
Treatment B: 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks."
106100|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106101|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106102|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106103|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106104|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106105|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106106|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106107|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106108|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106109|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106110|NCT01756157|E2|Reported Event|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106111|NCT01756157|E1|Reported Event|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
106136|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106112|NCT01756079|B1|Baseline|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
106113|NCT01756079|P1|Participant Flow|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
106114|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).
106115|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).
106116|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
106181|NCT01755637|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures
106117|NCT01756079|E1|Reported Event|Overall Participants: Lead-in, Treatment and Follow-up|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
106118|NCT01756053|B1|Baseline|All Study Subjects|Subjects who were randomized and received their Period 1 study medication (ABT-089 or matching placebo).
106119|NCT01756053|P2|Participant Flow|Placebo, Then ABT-089|"Those randomized to placebo (matching ABT-089 10 mg capsules) during study medication period 1 will take four capsules daily during a 10-day medication period. After a washout period of ~21 days, these subjects will then take four 10 mg capsules (40 mg) daily of ABT-089 for a second 10-day study medication period.
Placebo: Matching placebo capsules supplied by study drug supplier."
106120|NCT01756053|P1|Participant Flow|ABT-089, Then Placebo|"Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during a 10-day medication period. After a washout period of ~21 days, these subjects will then take four capsules of matching placebo daily for a second 10-day medication period.
ABT-089: Selective neuronal nicotinic receptor agonist."
106121|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106122|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106123|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106124|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106125|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106126|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106127|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106128|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106129|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106130|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106131|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106132|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106133|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106134|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106135|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
106137|NCT01756053|E2|Reported Event|Placebo|"Subjects were assigned to take four placebo capsules (matching ABT-089 10 mg) daily during a 10-day medication period.
Placebo: Matched placebo capsules supplied by study drug supplier."
106138|NCT01756053|E1|Reported Event|ABT-089|"Subjects were assigned to take four 10 mg capsules daily (40 mg daily) during a 10-day medication period.
ABT-089: Selective neuronal nicotinic receptor agonist."
106139|NCT01755702|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures.
106140|NCT01755702|P1|Participant Flow|Overall|"In this cross-over study, participants were randomly-assigned to a blinded treatment sequence. Each participant was expected to complete 1, 2, or 3 periods depending on number of headache episodes.
The following treatments were administered during the study.
1000/130mg paracetamol/caffeine (two 500/65mg caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approximately (approx.) 250 ml of water.
1000mg paracetamol (two 500mg caplets) plus placebo paracetamol/caffeine (two caplets) taken orally with approx. 250 ml of water.
400mg ibuprofen (two 200mg caplets) plus placebo paracetamol/caffeine (two caplets) for a total of four caplets taken orally with approx. 250 ml of water.
placebo paracetamol/caffeine (two caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approx. 250 ml of water."
106141|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
106142|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106143|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106144|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
106145|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
106146|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106148|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
106149|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
106150|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106151|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106152|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
106153|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
106154|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106155|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106156|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
106157|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
106158|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106159|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106160|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
106161|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
106162|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106163|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106164|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
106165|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
106166|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106167|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106168|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
106169|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
106170|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106171|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106172|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
106173|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
106174|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106175|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106176|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
106177|NCT01755702|E4|Reported Event|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
106178|NCT01755702|E3|Reported Event|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106179|NCT01755702|E2|Reported Event|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
106180|NCT01755702|E1|Reported Event|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
106182|NCT01755637|P2|Participant Flow|Albendazole (Alcohol) First, Then Albendazole (Aqua)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment followed by 400 mg aqua based albendazole tablets. A wash-out period of 7 days was maintained between treatment periods.
106183|NCT01755637|P1|Participant Flow|Albendazole (Aqua) First, Then Albendazole (Alcohol)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment, followed by single dose treatment of 400 mg albendazole tablets manufactured under ethanol based solvent conditions. A wash-out period of 7 days was maintained between treatment periods.
106184|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole Sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
106185|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole Sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
106186|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
106187|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
106188|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
106189|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
106190|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
106191|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
106192|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
106193|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
106194|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
106195|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
106196|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
106197|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
106262|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
106198|NCT01755637|E2|Reported Event|Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
106199|NCT01755637|E1|Reported Event|Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
106200|NCT01755455|B1|Baseline|All Study Participants|Includes those who started the study with First Intervention and those who started the study with Second Intervention
106201|NCT01755455|P2|Participant Flow|Ferrous Sulfate, Then Placebo|Ferrous Sulfate 325 mg administered daily for 6 weeks followed by 4-week washout, then Placebo administered daily for 6 weeks.
106202|NCT01755455|P1|Participant Flow|Placebo, Then Ferrous Sulfate|Placebo administered daily for 6 week followed by 4-week washout, then Ferrous Sulfate 325 mg administered daily for 6 weeks.
106203|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
106204|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
106205|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
106206|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
106207|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
106208|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
106209|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
106210|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
106211|NCT01755455|E2|Reported Event|Ferrous Sulfate|Events observed among all participants while they were receiving ferrous sulfate.
106212|NCT01755455|E1|Reported Event|Placebo|Events observed among all participants while they were receiving placebo.
106213|NCT01755234|B3|Baseline|Total|Total of all reporting groups
106214|NCT01755234|B2|Baseline|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
106215|NCT01755234|B1|Baseline|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
106216|NCT01755234|P2|Participant Flow|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
106217|NCT01755234|P1|Participant Flow|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
106218|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
106219|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
106220|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
106221|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
106222|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
106223|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
106224|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
106225|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
106226|NCT01755234|E2|Reported Event|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
106227|NCT01755234|E1|Reported Event|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
106228|NCT01755169|B5|Baseline|Total|Total of all reporting groups
106229|NCT01755169|B4|Baseline|Placebo|Placebo
106230|NCT01755169|B3|Baseline|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106263|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
106231|NCT01755169|B2|Baseline|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106232|NCT01755169|B1|Baseline|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106233|NCT01755169|P4|Participant Flow|Placebo|Placebo
106234|NCT01755169|P3|Participant Flow|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106235|NCT01755169|P2|Participant Flow|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106236|NCT01755169|P1|Participant Flow|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106237|NCT01755169|O4|Outcome|Placebo|Placebo
106238|NCT01755169|O3|Outcome|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106239|NCT01755169|O2|Outcome|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106240|NCT01755169|O1|Outcome|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106241|NCT01755169|E4|Reported Event|Placebo|Placebo
106242|NCT01755169|E3|Reported Event|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106243|NCT01755169|E2|Reported Event|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106244|NCT01755169|E1|Reported Event|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
106245|NCT01755156|B3|Baseline|Total|Total of all reporting groups
106246|NCT01755156|B2|Baseline|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
106247|NCT01755156|B1|Baseline|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
106248|NCT01755156|P2|Participant Flow|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106249|NCT01755156|P1|Participant Flow|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106250|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106251|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106252|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
106253|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
106254|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106255|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106256|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
106257|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
106258|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106259|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106260|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
106261|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
106264|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106265|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106266|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106267|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106268|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
106269|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
106270|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
106271|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
106272|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106273|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106274|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106275|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106276|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
106277|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
106278|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
106279|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
106280|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106281|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106282|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106283|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106284|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106285|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106286|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
106287|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
106288|NCT01755156|E4|Reported Event|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
106289|NCT01755156|E3|Reported Event|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
106290|NCT01755156|E2|Reported Event|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks.
106291|NCT01755156|E1|Reported Event|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
106293|NCT01755143|B2|Baseline|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System"
106294|NCT01755143|B1|Baseline|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System"
106295|NCT01755143|P2|Participant Flow|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System"
106296|NCT01755143|P1|Participant Flow|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System"
106297|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System"
106298|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System"
106299|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System"
106300|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System"
106301|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System"
106302|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System"
106303|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System"
106356|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106304|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System"
106305|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System"
106306|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System"
106307|NCT01755143|E2|Reported Event|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System"
106308|NCT01755143|E1|Reported Event|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System"
106309|NCT01755026|B3|Baseline|Total|Total of all reporting groups
106310|NCT01755026|B2|Baseline|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
106311|NCT01755026|B1|Baseline|4 Gram Dose|4 gram dose of pre-operative prophylaxis
106312|NCT01755026|P2|Participant Flow|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
106313|NCT01755026|P1|Participant Flow|4 Gram Dose|4 gram dose of pre-operative prophylaxis
106314|NCT01755026|O2|Outcome|4 Gram Dose|4 gram dose of pre-operative prophylaxis
106315|NCT01755026|O1|Outcome|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
106316|NCT01755026|E2|Reported Event|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
106317|NCT01755026|E1|Reported Event|4 Gram Dose|4 gram dose of pre-operative prophylaxis
106318|NCT01754922|B3|Baseline|Total|Total of all reporting groups
106319|NCT01754922|B2|Baseline|Control|Veterans deployed to regions other than Iraq or Afghanistan or non-deployed
106320|NCT01754922|B1|Baseline|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
106321|NCT01754922|P2|Participant Flow|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
106322|NCT01754922|P1|Participant Flow|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
106323|NCT01754922|O2|Outcome|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
106324|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
106325|NCT01754922|O2|Outcome|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
106326|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
106327|NCT01754922|O2|Outcome|Control|Veterans deployed to regions other than Iraq and Afghanistan or non-deployed
106328|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
106329|NCT01754922|E2|Reported Event|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia or non-deployed
106330|NCT01754922|E1|Reported Event|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
106331|NCT01754766|B4|Baseline|Total|Total of all reporting groups
106332|NCT01754766|B3|Baseline|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
106333|NCT01754766|B2|Baseline|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
106334|NCT01754766|B1|Baseline|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
106337|NCT01754766|P1|Participant Flow|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
106338|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
106339|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
106340|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
106341|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
106342|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
106343|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
106344|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
106345|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
106346|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
106347|NCT01754766|E3|Reported Event|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
106348|NCT01754766|E2|Reported Event|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
106349|NCT01754766|E1|Reported Event|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
106350|NCT01754727|B1|Baseline|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106351|NCT01754727|P1|Participant Flow|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106352|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106353|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106354|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106355|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106357|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106358|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106359|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106360|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106361|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106362|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106363|NCT01754727|E1|Reported Event|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
106364|NCT01754714|B5|Baseline|Total|Total of all reporting groups
106365|NCT01754714|B4|Baseline|No Treatment|no study drug was administered
106366|NCT01754714|B3|Baseline|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106367|NCT01754714|B2|Baseline|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106368|NCT01754714|B1|Baseline|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106369|NCT01754714|P4|Participant Flow|No Treatment|No study drug was administered
106370|NCT01754714|P3|Participant Flow|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106371|NCT01754714|P2|Participant Flow|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106372|NCT01754714|P1|Participant Flow|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106373|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106374|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106375|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106376|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106377|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106378|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106379|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106380|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106381|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106382|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106383|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106574|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection
Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
106384|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106385|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106386|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106387|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106388|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106389|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106390|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106391|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106392|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106393|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106394|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106395|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106396|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106397|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106398|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106399|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106400|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106401|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106402|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106403|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106404|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106405|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106406|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106407|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106408|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106409|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106410|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106411|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106412|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106413|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106414|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106415|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106416|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106417|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106418|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106419|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106420|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106421|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106422|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106423|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106424|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106425|NCT01754714|O4|Outcome|No Treatment|
106426|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106427|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106428|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106429|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106430|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106431|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106432|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106433|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106434|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106435|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106436|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106437|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106438|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106439|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106440|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106441|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106442|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106443|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106444|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106445|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106446|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106447|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106448|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106449|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106450|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106451|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106452|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106453|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
106454|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106455|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106456|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106457|NCT01754714|E4|Reported Event|No Treatment|No study drug was administered
106458|NCT01754714|E3|Reported Event|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
106459|NCT01754714|E2|Reported Event|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
106460|NCT01754714|E1|Reported Event|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
106461|NCT01754623|B1|Baseline|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery."
106462|NCT01754623|P1|Participant Flow|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery."
106463|NCT01754623|O2|Outcome|Resection Group -Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery."
106464|NCT01754623|O1|Outcome|All Participants -Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery."
106465|NCT01754623|O1|Outcome|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery."
106466|NCT01754623|O1|Outcome|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery."
106467|NCT01754623|E1|Reported Event|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery."
106468|NCT01754519|B1|Baseline|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Therapeutic Conventional Surgery: Undergo wide local excision breast surgery
Radiation Therapy: Undergo SFRT
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies"
106469|NCT01754519|P1|Participant Flow|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Therapeutic Conventional Surgery: Undergo wide local excision breast surgery
Radiation Therapy: Undergo SFRT
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies"
106470|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Therapeutic Conventional Surgery: Undergo wide local excision breast surgery
Radiation Therapy: Undergo SFRT
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies"
106471|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Therapeutic Conventional Surgery: Undergo wide local excision breast surgery
Radiation Therapy: Undergo SFRT
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies"
106472|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Therapeutic Conventional Surgery: Undergo wide local excision breast surgery
Radiation Therapy: Undergo SFRT
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies"
106473|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Therapeutic Conventional Surgery: Undergo wide local excision breast surgery
Radiation Therapy: Undergo SFRT
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies"
106493|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
106474|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Therapeutic Conventional Surgery: Undergo wide local excision breast surgery
Radiation Therapy: Undergo SFRT
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies"
106475|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Therapeutic Conventional Surgery: Undergo wide local excision breast surgery
Radiation Therapy: Undergo SFRT
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies"
106476|NCT01754519|E1|Reported Event|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Therapeutic Conventional Surgery: Undergo wide local excision breast surgery
Radiation Therapy: Undergo SFRT
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies"
106477|NCT01754493|B1|Baseline|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine
Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
106478|NCT01754493|P1|Participant Flow|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine
Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
106479|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine
Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
106480|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine
Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
106481|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine
Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
106482|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine
Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
106483|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine
Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
106549|NCT01754376|P1|Participant Flow|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin
Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.
Vemurafenib: Tablets given twice daily."
106484|NCT01754493|E1|Reported Event|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine
Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
106485|NCT01754480|B3|Baseline|Total|Total of all reporting groups
106486|NCT01754480|B2|Baseline|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
106487|NCT01754480|B1|Baseline|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
106488|NCT01754480|P2|Participant Flow|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
106489|NCT01754480|P1|Participant Flow|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
106490|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
106491|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
106492|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
106692|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
106494|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
106495|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
106496|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
106497|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
106498|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
106499|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
106500|NCT01754480|E2|Reported Event|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
106501|NCT01754480|E1|Reported Event|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
106502|NCT01754467|B1|Baseline|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.
NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
106503|NCT01754467|P1|Participant Flow|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.
NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
106504|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.
NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
106505|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.
NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
106506|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.
NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
106507|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.
NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
106572|NCT01754194|P1|Participant Flow|Procedure Type 1|"Gastric Sleeve Resection
Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
106508|NCT01754467|E1|Reported Event|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.
NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
106509|NCT01754402|B4|Baseline|Total|Total of all reporting groups
106510|NCT01754402|B3|Baseline|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.
Study treatment will be administered at the Maximum Tolerated Dose."
106511|NCT01754402|B2|Baseline|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.
Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
106512|NCT01754402|B1|Baseline|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.
Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
106513|NCT01754402|P3|Participant Flow|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.
Study treatment will be administered at the Maximum Tolerated Dose."
106532|NCT01754389|O1|Outcome|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate
Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
106514|NCT01754402|P2|Participant Flow|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.
Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
106515|NCT01754402|P1|Participant Flow|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.
Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
106516|NCT01754402|O3|Outcome|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.
Study treatment will be administered at the Maximum Tolerated Dose."
106517|NCT01754402|O2|Outcome|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.
Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
106518|NCT01754402|O1|Outcome|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.
Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
106519|NCT01754402|O1|Outcome|Cohorts 1 and 2|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. (Dose escalation)
Bendamustine: Bendamustine 120mg/m2 (cohort 1, 2) or 150 mg/m2 (cohort 3), or 180mg/m2 (cohort 4) will be administered intravenously on day 1, every 28 days for 12 cycles.
Pomalidomide: Pomalidomide 3mg (cohort 1) or 4mg (cohort 2, 3, 4) will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.
Dexamethasone: Dexamethasone will be administered weekly orally or intravenously on days 1, 8,"
106520|NCT01754402|E3|Reported Event|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days"
106521|NCT01754402|E2|Reported Event|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days"
106522|NCT01754402|E1|Reported Event|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days"
106523|NCT01754389|B4|Baseline|Total|Total of all reporting groups
106573|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
106524|NCT01754389|B3|Baseline|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade
Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant
Sirolimus"
106525|NCT01754389|B2|Baseline|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade
Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant
Bortezomib"
106526|NCT01754389|B1|Baseline|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate
Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
106527|NCT01754389|P3|Participant Flow|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade
Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
106528|NCT01754389|P2|Participant Flow|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade
Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
106529|NCT01754389|P1|Participant Flow|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate
Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
106530|NCT01754389|O3|Outcome|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade
Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
106531|NCT01754389|O2|Outcome|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade
Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
106689|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106533|NCT01754389|O3|Outcome|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade
Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
106534|NCT01754389|O2|Outcome|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade
Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
106535|NCT01754389|O1|Outcome|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate
Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
106536|NCT01754389|O3|Outcome|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade
Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
106537|NCT01754389|O2|Outcome|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade
Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
106538|NCT01754389|O1|Outcome|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate
Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
106539|NCT01754389|O3|Outcome|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade
Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
106540|NCT01754389|O2|Outcome|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade
Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
106541|NCT01754389|O1|Outcome|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate
Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
106542|NCT01754389|O3|Outcome|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade
Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
106543|NCT01754389|O2|Outcome|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade
Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
106544|NCT01754389|O1|Outcome|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate
Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
106545|NCT01754389|E3|Reported Event|Arm C (Experimental)|"Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade
Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant"
106546|NCT01754389|E2|Reported Event|Arm B (Experimental)|"Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade
Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant"
106547|NCT01754389|E1|Reported Event|Arm A (Standard of Care)|"Drug: Tacrolimus, Methotrexate
Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant"
106548|NCT01754376|B1|Baseline|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin
Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.
Vemurafenib: Tablets given twice daily."
106550|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)
The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.
A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.
Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.
Vemurafenib: Tablets given twice daily."
106551|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)
The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.
A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.
Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.
Vemurafenib: Tablets given twice daily."
106552|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)
The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.
A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.
Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.
Vemurafenib: Tablets given twice daily."
106553|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)
The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.
A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.
Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.
Vemurafenib: Tablets given twice daily."
106690|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
106554|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)
The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.
A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.
Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.
Vemurafenib: Tablets given twice daily."
106555|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin
Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.
Vemurafenib: Tablets given twice daily."
106556|NCT01754376|E1|Reported Event|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin
Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.
Vemurafenib: Tablets given twice daily."
106557|NCT01754259|B3|Baseline|Total|Total of all reporting groups
106558|NCT01754259|B2|Baseline|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
106559|NCT01754259|B1|Baseline|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
106560|NCT01754259|P2|Participant Flow|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
106561|NCT01754259|P1|Participant Flow|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
106562|NCT01754259|O2|Outcome|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
106563|NCT01754259|O1|Outcome|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
106564|NCT01754259|O2|Outcome|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
106565|NCT01754259|O1|Outcome|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
106566|NCT01754259|E2|Reported Event|Placebo|"Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
106567|NCT01754259|E1|Reported Event|Ranolazine|"subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor."
106568|NCT01754194|B3|Baseline|Total|Total of all reporting groups
106569|NCT01754194|B2|Baseline|Procedure Type 2|"Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
106570|NCT01754194|B1|Baseline|Procedure Type 1|"Gastric Sleeve Resection
Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
106571|NCT01754194|P2|Participant Flow|Procedure Type 2|"Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
106575|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
106576|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection
Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
106577|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
106578|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection
Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
106579|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
106580|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection
Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
106581|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
106582|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection
Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
106583|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
106584|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection
Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
106585|NCT01754194|O2|Outcome|Procedure Type 2|"Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass"
106586|NCT01754194|O1|Outcome|Procedure Type 1|"Gastric Sleeve Resection
Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection"
106587|NCT01754194|O2|Outcome|Procedure Type II|Roux-en-Y Gastric Bypass
106588|NCT01754194|O1|Outcome|Procedure Type I|Gastric Sleeve Resection
106589|NCT01754194|E2|Reported Event|Procedure Type II|Roux-en-Y Gastric Bypass
106590|NCT01754194|E1|Reported Event|Procedure Type I|Gastric Sleeve Resection
106591|NCT01753856|B3|Baseline|Total|Total of all reporting groups
106691|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106592|NCT01753856|B2|Baseline|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106593|NCT01753856|B1|Baseline|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106594|NCT01753856|P2|Participant Flow|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106595|NCT01753856|P1|Participant Flow|Teriparatide|"Teriparatide: 20-microgram (µg) subcutaneous (SC) injection once daily for 6 months.
DEM: 150-milligram (mg) tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 milligrams per day (mg/day) administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 International Units per day (IU/day) administered orally for 6 months."
106596|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106597|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106598|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106599|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106600|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106601|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106602|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106654|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106603|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106604|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106605|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106606|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106607|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106608|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106609|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106610|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106646|NCT01753713|B1|Baseline|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
107147|NCT01751022|B1|Baseline|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant
106611|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106612|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106613|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106614|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106615|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106616|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106617|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106618|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106619|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106620|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106621|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106647|NCT01753713|P2|Participant Flow|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106622|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106623|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106624|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106686|NCT01753518|P1|Participant Flow|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
106625|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106626|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106627|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106628|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106629|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106630|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106631|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106632|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106648|NCT01753713|P1|Participant Flow|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
107148|NCT01751022|P3|Participant Flow|Model 4598|Patients with an implant attempt for the Attain Performa Lead Model 4598
106633|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106634|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106635|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106636|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106637|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106638|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106639|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106640|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106641|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106642|NCT01753856|E2|Reported Event|Denosumab|"Denosumab: A single 60-mg SC injection.
DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106643|NCT01753856|E1|Reported Event|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.
DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:
Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.
Days 4 through 15: DEM was not administered.
TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:
Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.
Days 4 through 15: TET was not administered.
Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.
Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
106644|NCT01753713|B3|Baseline|Total|Total of all reporting groups
106645|NCT01753713|B2|Baseline|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106649|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106650|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106651|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106652|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106653|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106687|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106655|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106656|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106657|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106658|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106659|NCT01753713|O2|Outcome|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106660|NCT01753713|O1|Outcome|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106661|NCT01753713|E2|Reported Event|Anti-angiogenic Therapy Patients|"Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106662|NCT01753713|E1|Reported Event|Anti-angiogenic Therapy Naive Patients|"Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
dovitinib: Given PO
laboratory biomarker analysis: Correlative studies"
106663|NCT01753557|B3|Baseline|Total|Total of all reporting groups
106664|NCT01753557|B2|Baseline|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106665|NCT01753557|B1|Baseline|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106666|NCT01753557|P2|Participant Flow|Treatment-Relapsed|Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106667|NCT01753557|P1|Participant Flow|Treatment-Naive|Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106668|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106669|NCT01753557|O1|Outcome|Treatment-Naïve|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106670|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106671|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106672|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106673|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106674|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
107149|NCT01751022|P2|Participant Flow|Model 4398|Patients with an implant attempt for the Attain Performa Lead Model 4398
106675|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106676|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106677|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106678|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106679|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106680|NCT01753557|E2|Reported Event|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106681|NCT01753557|E1|Reported Event|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
106682|NCT01753518|B3|Baseline|Total|Total of all reporting groups
106683|NCT01753518|B2|Baseline|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106684|NCT01753518|B1|Baseline|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
106685|NCT01753518|P2|Participant Flow|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106693|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106694|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
106695|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106696|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
106697|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106698|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
106699|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106700|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
106701|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106702|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
106703|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106704|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
106705|NCT01753518|E2|Reported Event|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
106706|NCT01753518|E1|Reported Event|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
106707|NCT01753336|B1|Baseline|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
106708|NCT01753336|P1|Participant Flow|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 Units (U)/vial, 2 millilitre (mL) dilution on Day 1 of up to 3 treatment cycles. Subjects who were botulinum neurotoxin (BoNT) treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum toxin type A haemagglutinin complex (abobotulinumtoxinA).
106725|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106709|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
106710|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
106711|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
106739|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106740|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106741|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106742|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106712|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
106713|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
106714|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
106715|NCT01753336|E1|Reported Event|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
106716|NCT01753323|B4|Baseline|Total|Total of all reporting groups
106717|NCT01753323|B3|Baseline|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106718|NCT01753323|B2|Baseline|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106719|NCT01753323|B1|Baseline|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106720|NCT01753323|P3|Participant Flow|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106721|NCT01753323|P2|Participant Flow|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106722|NCT01753323|P1|Participant Flow|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106723|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106724|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106726|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106727|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106728|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106729|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106730|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106731|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106732|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106733|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106734|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106735|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106736|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106737|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106738|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
107396|NCT01748799|O4|Outcome|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
106743|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106744|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106745|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106746|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106747|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106748|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106749|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106750|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106751|NCT01753323|O3|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106752|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106753|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106754|NCT01753323|E3|Reported Event|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
106755|NCT01753323|E2|Reported Event|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
106756|NCT01753323|E1|Reported Event|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
106757|NCT01753310|B3|Baseline|Total Title|
106758|NCT01753310|B2|Baseline|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
106759|NCT01753310|B1|Baseline|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
106760|NCT01753310|P2|Participant Flow|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
106761|NCT01753310|P1|Participant Flow|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
106762|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
106763|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
106764|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
106765|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
106766|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
106767|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
106768|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
106796|NCT01753076|P2|Participant Flow|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46.
106769|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
106770|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
106771|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
106772|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
106773|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
106774|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
106775|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
106776|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
106777|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
106778|NCT01753310|E2|Reported Event|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
106779|NCT01753310|E1|Reported Event|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
106780|NCT01753115|B4|Baseline|Total|Total of all reporting groups
106781|NCT01753115|B3|Baseline|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
106782|NCT01753115|B2|Baseline|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day"
106783|NCT01753115|B1|Baseline|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day"
106784|NCT01753115|P3|Participant Flow|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
106785|NCT01753115|P2|Participant Flow|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day"
106786|NCT01753115|P1|Participant Flow|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day"
106787|NCT01753115|O2|Outcome|BioThrax Only (Arm 3)|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
106788|NCT01753115|O1|Outcome|BioThrax + Ciprofloxacin (Arms 1 + 2)|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day"
106789|NCT01753115|O1|Outcome|Arm 1 = BioThrax (0.5 mL) + Ciprofloxacin (500 mg Bid) + PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day"
106790|NCT01753115|E3|Reported Event|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
106791|NCT01753115|E2|Reported Event|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day"
106792|NCT01753115|E1|Reported Event|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day"
106793|NCT01753076|B3|Baseline|Total|Total of all reporting groups
106794|NCT01753076|B2|Baseline|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46.
106795|NCT01753076|B1|Baseline|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46.
106797|NCT01753076|P1|Participant Flow|Placebo|Participants (par) received placebo once every 2 weeks by intravenous infusion up to Week 46.
106798|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106799|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106800|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106801|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106802|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106803|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106804|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 mg/kg once every 2 weeks by intravenous infusion up to Week 46. Outcome assessments conducted at Week 48 and Week 60.
106805|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Outcome assessments conducted at Week 48 and Week 60.
106806|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106807|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106808|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106809|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106810|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106811|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106812|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106813|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106814|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106815|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106816|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
106817|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
107150|NCT01751022|P1|Participant Flow|Model 4298|Patients with an implant attempt for the Attain Performa Lead Model 4298
106818|NCT01753076|E2|Reported Event|Ozanezumab IV|Participants received ozanezumab 15 mg/kg once every 2 weeks by intravenous infusion up to Week 46.
106819|NCT01753076|E1|Reported Event|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46.
106820|NCT01752907|B3|Baseline|Total|Total of all reporting groups
106821|NCT01752907|B2|Baseline|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106822|NCT01752907|B1|Baseline|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106823|NCT01752907|P2|Participant Flow|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106824|NCT01752907|P1|Participant Flow|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106825|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106826|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106827|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106828|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106829|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106830|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106831|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106832|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106833|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106834|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106835|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106836|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106837|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106838|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106868|NCT01752023|O1|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.
Arm A: Experimental Arm"
106839|NCT01752907|E2|Reported Event|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106840|NCT01752907|E1|Reported Event|General Chemotherapy Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
106841|NCT01752855|B3|Baseline|Total|Total of all reporting groups
106842|NCT01752855|B2|Baseline|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106843|NCT01752855|B1|Baseline|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106844|NCT01752855|P2|Participant Flow|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106845|NCT01752855|P1|Participant Flow|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106846|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106847|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106848|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106849|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106850|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106851|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106852|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106853|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106854|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106855|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106856|NCT01752855|E2|Reported Event|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
106857|NCT01752855|E1|Reported Event|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week.
106858|NCT01752023|B3|Baseline|Total|Total of all reporting groups
106859|NCT01752023|B2|Baseline|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.
Arm B: Active Comparator"
106860|NCT01752023|B1|Baseline|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.
Arm A: Experimental Arm"
106861|NCT01752023|P2|Participant Flow|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.
Arm B: Active Comparator"
106862|NCT01752023|P1|Participant Flow|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.
Arm A: Experimental Arm"
106863|NCT01752023|O2|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.
Arm B: Active Comparator"
106864|NCT01752023|O1|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.
Arm A: Experimental Arm"
106865|NCT01752023|O2|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.
Arm B: Active Comparator"
106866|NCT01752023|O1|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.
Arm A: Experimental Arm"
106867|NCT01752023|O2|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.
Arm B: Active Comparator"
107151|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted successfully.
106869|NCT01752023|O2|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.
Cisplatin + Gemcitabine: Active Comparator"
106870|NCT01752023|O1|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.
Cisplatin + Gemcitabine with SUBATM-itraconazole: Experimental Arm"
106871|NCT01752023|O2|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.
Arm B: Active Comparator"
106872|NCT01752023|O1|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.
Arm A: Experimental Arm"
106873|NCT01752023|O2|Outcome|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.
Arm B: Active Comparator"
106874|NCT01752023|O1|Outcome|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.
Arm A: Experimental Arm"
106875|NCT01752023|E2|Reported Event|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.
Arm B: Active Comparator"
106876|NCT01752023|E1|Reported Event|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.
Arm A: Experimental Arm"
106877|NCT01751867|B3|Baseline|Total|Total of all reporting groups
106878|NCT01751867|B2|Baseline|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
106879|NCT01751867|B1|Baseline|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
106880|NCT01751867|P2|Participant Flow|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
106881|NCT01751867|P1|Participant Flow|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
106882|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
106883|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
106884|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
106885|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
106886|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
106887|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
106888|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
106889|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
106890|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
106891|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
106892|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
106893|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
106894|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
106895|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
106896|NCT01751867|E2|Reported Event|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
106897|NCT01751867|E1|Reported Event|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
106898|NCT01751802|B3|Baseline|Total|Total of all reporting groups
106899|NCT01751802|B2|Baseline|Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
106900|NCT01751802|B1|Baseline|Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
107152|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
106901|NCT01751802|P2|Participant Flow|Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
106902|NCT01751802|P1|Participant Flow|Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
106903|NCT01751802|O2|Outcome|Placebo|"Inactive substance being tested, orally once a day at bedtime for 6 weeks
Placebo: Placebo for Ecopipam"
106904|NCT01751802|O1|Outcome|Ecopipam|"Active substance being tested, orally once a day at bedtime for 6 weeks
Ecopipam: Antagonist of the dopamine D1 receptor"
106905|NCT01751802|O2|Outcome|Placebo|"Inactive substance being tested, orally once a day at bedtime
Placebo: Placebo for Ecopipam"
106906|NCT01751802|O1|Outcome|Ecopipam|"Active substance being tested, orally once a day at bedtime
Ecopipam: Antagonist of the dopamine D1 receptor"
106907|NCT01751802|O4|Outcome|Subject #4: Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
106908|NCT01751802|O3|Outcome|Subject #3: Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
106909|NCT01751802|O2|Outcome|Subject #2: Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
106910|NCT01751802|O1|Outcome|Subject #1: Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
106911|NCT01751802|E2|Reported Event|Placebo|"Inactive substance being tested, orally once a day at bedtime
Placebo: Placebo for Ecopipam"
106912|NCT01751802|E1|Reported Event|Ecopipam|"Active substance being tested, orally once a day at bedtime
Ecopipam: Antagonist of the dopamine D1 receptor"
106913|NCT01751724|B3|Baseline|Total|Total of all reporting groups
106914|NCT01751724|B2|Baseline|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106915|NCT01751724|B1|Baseline|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106916|NCT01751724|P2|Participant Flow|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106917|NCT01751724|P1|Participant Flow|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106918|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
107153|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
106919|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106920|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106921|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106922|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106923|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106924|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106925|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106926|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106927|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106928|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106968|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106969|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
106929|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106930|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106931|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106932|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106933|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106934|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106935|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106936|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106937|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106938|NCT01751724|O2|Outcome|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106970|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AEor death (from any cause).
106971|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106939|NCT01751724|O1|Outcome|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106940|NCT01751724|E2|Reported Event|Placebo Arm|"Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106941|NCT01751724|E1|Reported Event|Caffeine Arm|"Subjects randomized to this arm will receive blinded Caffeine citrate.
Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
106942|NCT01751386|B3|Baseline|Total|Total of all reporting groups
106943|NCT01751386|B2|Baseline|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
106944|NCT01751386|B1|Baseline|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
106945|NCT01751386|P2|Participant Flow|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
107164|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant
106946|NCT01751386|P1|Participant Flow|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
106947|NCT01751386|O2|Outcome|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
106948|NCT01751386|O1|Outcome|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
106949|NCT01751386|E2|Reported Event|Placebo|Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
106950|NCT01751386|E1|Reported Event|Baclofen|Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
106951|NCT01751308|B6|Baseline|Total|Total of all reporting groups
106952|NCT01751308|B5|Baseline|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106953|NCT01751308|B4|Baseline|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106954|NCT01751308|B3|Baseline|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106955|NCT01751308|B2|Baseline|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106956|NCT01751308|B1|Baseline|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106957|NCT01751308|P5|Participant Flow|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106958|NCT01751308|P4|Participant Flow|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106959|NCT01751308|P3|Participant Flow|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106960|NCT01751308|P2|Participant Flow|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106961|NCT01751308|P1|Participant Flow|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (DP) or discontinuation due to adverse events (AE) or death (from any cause).
106962|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106963|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106964|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106965|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
106966|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106967|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106972|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106973|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
106974|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106975|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106976|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106977|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
106978|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106979|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106980|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106981|NCT01751308|O3|Outcome|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106982|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106983|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
107165|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant
106984|NCT01751308|O5|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106985|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106986|NCT01751308|O3|Outcome|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106987|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106988|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106989|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106990|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106991|NCT01751308|O1|Outcome|Phase 1: Overall Population|Cabazitaxel 20 mg/m^2, 25 mg/m^2, 30 mg/m^2 or 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106992|NCT01751308|E5|Reported Event|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106993|NCT01751308|E4|Reported Event|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106994|NCT01751308|E3|Reported Event|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106995|NCT01751308|E2|Reported Event|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106996|NCT01751308|E1|Reported Event|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
106997|NCT01751178|B4|Baseline|Total|Total of all reporting groups
106998|NCT01751178|B3|Baseline|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
106999|NCT01751178|B2|Baseline|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107000|NCT01751178|B1|Baseline|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107001|NCT01751178|P3|Participant Flow|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
107002|NCT01751178|P2|Participant Flow|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107003|NCT01751178|P1|Participant Flow|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107004|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
107005|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107341|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine"
107006|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107007|NCT01751178|O3|Outcome|Reference|Brusing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
107008|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107009|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107010|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks
107011|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107012|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107013|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
107014|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107015|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107016|NCT01751178|E3|Reported Event|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
107166|NCT01751022|O3|Outcome|Model 4598|Patients with an implant attempt for the Attain Performa Lead Model 4598
107017|NCT01751178|E2|Reported Event|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107018|NCT01751178|E1|Reported Event|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
107019|NCT01751165|B4|Baseline|Total|Total of all reporting groups
107020|NCT01751165|B3|Baseline|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107021|NCT01751165|B2|Baseline|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107022|NCT01751165|B1|Baseline|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107023|NCT01751165|P3|Participant Flow|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107024|NCT01751165|P2|Participant Flow|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107025|NCT01751165|P1|Participant Flow|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107026|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107027|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107028|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107029|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107030|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107031|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107032|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107033|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107034|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107035|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107036|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107037|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107038|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107039|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107040|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107041|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107042|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107043|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107044|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107045|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107046|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107047|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107048|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107049|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107050|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107051|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107052|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107053|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107054|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107055|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107056|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107057|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107058|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107059|NCT01751165|O2|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107060|NCT01751165|O1|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107061|NCT01751165|E3|Reported Event|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
107062|NCT01751165|E2|Reported Event|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
107063|NCT01751165|E1|Reported Event|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
107064|NCT01751113|B1|Baseline|Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg|All participants received one of the following 3 treatments in one of three 4-week treatment periods separated by a 2-week washout period:Ado 50/250 µg BID (morning and evening) + Tio 18 µg QD (morning), Ado 50/250 µg BID (morning and evening) + Tio matching placebo QD (morning), and Tio 18 µg QD (morning) + Ado matching placebo BID (morning and evening). Participants were randomized to one of the 6 following treatment sequences: (1) Ado 50/250 µg+Tio 18 µg, Tio 18 µg, Ado 50/250 µg (2) Tio 18 µg, Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg (3) Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg, Tio 18 µg (4) Ado 50/250 µg, Tio 18 µg, Ado 50/250 µg+Tio 18 µg (5) Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg (6) Tio 18 µg, Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg. Ado 50/250 µg and its matching placebo were administered via DISKUS inhaler and Tio 18 µg and its matching placebo were administered via HandiHaler inhaler. Participants used salbutamol inhaler as relief medication throughout the study.
107065|NCT01751113|P6|Participant Flow|Sequence 6: Tio 18 µg, Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg|Participants received Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), Ado 50/250 µg BID plus Tio 18 µg QD (morning), and Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with salbutamol inhaler to be used as relief medication throughout the study.
107066|NCT01751113|P5|Participant Flow|Sequence 5: Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg|Participants received Ado 50/250 µg BID plus Tio 18 µg QD (morning), Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) and Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with salbutamol inhaler to be used as relief medication throughout the study.
107067|NCT01751113|P4|Participant Flow|Sequence 4: Ado 50/250 µg, Tio 18 µg, Ado 50/250 µg+Tio 18 µg|Participants received Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), and Ado 50/250 µg BID plus Tio 18 µg QD (morning) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107121|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107068|NCT01751113|P3|Participant Flow|Sequence 3: Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg, Tio 18 µg|Participants received Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), Ado 50/250 µg BID plus Tio 18 µg QD (morning), and Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107069|NCT01751113|P2|Participant Flow|Sequence 2: Tio 18 µg, Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg|Participants received Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), and Ado 50/250 µg BID plus Tio 18 µg QD (morning) in Treatment Periods 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107070|NCT01751113|P1|Participant Flow|Sequence 1: Ado 50/250 µg+Tio 18 µg, Tio 18 µg, Ado 50/250 µg|Participants received salmeterol xinafoate/fluticasone propionate (Ado) 50/250 micrograms (µg) twice daily (BID) (morning and evening) plus tiotropium bromide (Tio) 18 µg once daily (QD) (morning), Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), and Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) in Treatment Periods 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107167|NCT01751022|O2|Outcome|Model 4398|Patients with an implant attempt for the Attain Performa Lead Model 4398
107071|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107072|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107073|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107074|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107075|NCT01751113|O2|Outcome|Tio 18 µg BID|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107076|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107077|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107078|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107079|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107080|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107081|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107082|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107083|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107084|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107085|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107086|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107087|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107168|NCT01751022|O1|Outcome|Model 4298|Patients with an implant attempt for the Attain Performa Lead Model 4298
107088|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107089|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107090|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107091|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107092|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107093|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107094|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107095|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107096|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107097|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107098|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107099|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107146|NCT01751022|B2|Baseline|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant
107100|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107101|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107102|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107103|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107104|NCT01751113|E3|Reported Event|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107105|NCT01751113|E2|Reported Event|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107106|NCT01751113|E1|Reported Event|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
107107|NCT01751087|B4|Baseline|Total|Total of all reporting groups
107108|NCT01751087|B3|Baseline|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107109|NCT01751087|B2|Baseline|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107110|NCT01751087|B1|Baseline|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107111|NCT01751087|P3|Participant Flow|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107112|NCT01751087|P2|Participant Flow|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107113|NCT01751087|P1|Participant Flow|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107114|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107115|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107116|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107117|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107118|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107119|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107120|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107122|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107123|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107124|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107125|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107126|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107127|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107169|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month.
107128|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107129|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107130|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107131|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107132|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107133|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107134|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107135|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107136|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107137|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107138|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107139|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107140|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107141|NCT01751087|E3|Reported Event|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2"
107142|NCT01751087|E2|Reported Event|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1"
107143|NCT01751087|E1|Reported Event|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2"
107144|NCT01751022|B4|Baseline|Total|Total of all reporting groups
107145|NCT01751022|B3|Baseline|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant
107154|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
107155|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
107156|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
107157|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted successfully.
107158|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
107159|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
107160|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
107161|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up.
107162|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
107163|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant
107170|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
107171|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
107172|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
107173|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
107174|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
107175|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
107176|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
107177|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
107178|NCT01751022|E3|Reported Event|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant. Results as showed in the Model 4598 PMA-S Clinical Report Version 1, 29AUG2014.
107179|NCT01751022|E2|Reported Event|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant. Results as showed in the Model 4398 PMA-S Clinical Report Version 3, 03SEP2014.
107180|NCT01751022|E1|Reported Event|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant. Results as showed in the Model 4298 PMA-S Clinical Report Version 1, 27MAR2014.
107181|NCT01750931|B1|Baseline|GSK-meloxicam 15 mg + Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test (GSK-meloxicam 15 mg tablet) or reference (Mobic-meloxicam 15 mg tablet) product as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
107182|NCT01750931|P2|Participant Flow|Mobic-meloxicam Then GSK-meloxicam|In this period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) followed by test (GSK-meloxicam 15 mg tablet) product as per the randomization schedule with 240 milliliters (mL) of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 ante meridiem (am) to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
107183|NCT01750931|P1|Participant Flow|GSK-meloxicam Then Mobic-meloxicam|In this period of the study, participants received a single oral dose of test (GSK-meloxicam 15 mg tablet) followed by reference (Mobic-meloxicam 15 mg tablet) product as per the randomization schedule with 240 milliliters (mL) of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 ante meridiem (am) to 08:56 am in each study period. A washout period of 14 days was maintained between the dosing of each period.
107184|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107342|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily
Betaine"
107185|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107186|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107187|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107188|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107189|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107190|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107209|NCT01750684|P1|Participant Flow|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.
Placebo"
107191|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107192|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107193|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107194|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107195|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107196|NCT01750931|O2|Outcome|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107197|NCT01750931|O1|Outcome|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107198|NCT01750931|E2|Reported Event|Mobic-meloxicam 15 mg|In each period of the study, participants received a single oral dose of reference (Mobic-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107199|NCT01750931|E1|Reported Event|GSK-meloxicam 15 mg|In each period of the study, participants received a single oral dose of test product (GSK-meloxicam 15 mg tablet) as per the randomization schedule with 240 mL of water 30 minutes after start of consumption of high fat high calorie breakfast on an overnight fast of at least 10 hours. Dosing was scheduled at specific intervals between 08:30 am to 08:56 am in each study period.
107200|NCT01750840|B1|Baseline|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
107201|NCT01750840|P1|Participant Flow|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
107229|NCT01750502|E1|Reported Event|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
107269|NCT01750346|E2|Reported Event|0.025% AH-8|"Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
Topical acetyl hexapeptide-8"
107486|NCT01748916|B1|Baseline|All Groups (Average)|All study participants
107202|NCT01750840|O1|Outcome|Stimulation Group|"All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
Biomet EBI Bone Healing System: A pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day.
Biomet Orthopak Non-Invasive Bone Growth Stimulator: A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.
Biomet SpinalPak Non-Invasive Spine Fusion Stimulator System: A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day."
107203|NCT01750840|O1|Outcome|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
107204|NCT01750840|E1|Reported Event|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
107205|NCT01750684|B3|Baseline|Total|Total of all reporting groups
107206|NCT01750684|B2|Baseline|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.
AC105"
107207|NCT01750684|B1|Baseline|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.
Placebo"
107208|NCT01750684|P2|Participant Flow|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.
AC105"
107210|NCT01750684|O2|Outcome|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.
AC105"
107211|NCT01750684|O1|Outcome|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.
Placebo"
107212|NCT01750684|E2|Reported Event|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.
AC105"
107213|NCT01750684|E1|Reported Event|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.
Placebo"
107214|NCT01750502|B3|Baseline|Total|Total of all reporting groups
107215|NCT01750502|B2|Baseline|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
107216|NCT01750502|B1|Baseline|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
107217|NCT01750502|P2|Participant Flow|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
107218|NCT01750502|P1|Participant Flow|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
107219|NCT01750502|O2|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
107220|NCT01750502|O1|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
107221|NCT01750502|O2|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
107222|NCT01750502|O1|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
107223|NCT01750502|O3|Outcome|5 Minutes After the Opening of the Balloon|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
107224|NCT01750502|O2|Outcome|After Surgery 5 Minutes|Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.
107225|NCT01750502|O1|Outcome|Before Surgery 5 Minutes|Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.
107226|NCT01750502|O2|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
107227|NCT01750502|O1|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
107228|NCT01750502|E2|Reported Event|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
107230|NCT01750398|B1|Baseline|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.
Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.
Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
107231|NCT01750398|P1|Participant Flow|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.
Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.
Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
107283|NCT01750281|O2|Outcome|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
107284|NCT01750281|O1|Outcome|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
107285|NCT01750281|O3|Outcome|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
107286|NCT01750281|O2|Outcome|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
107287|NCT01750281|O1|Outcome|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
107232|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.
Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.
Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
107233|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.
Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.
Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
107234|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.
Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.
Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
107235|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.
Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.
Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
107236|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.
Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.
Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
107266|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107267|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107268|NCT01750346|E3|Reported Event|Placebo|"Participants in the Placebo arm received the placebo.
Topical acetyl hexapeptide-8"
107237|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.
Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.
Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
107238|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.
Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.
Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
107239|NCT01750398|E1|Reported Event|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.
Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.
Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
107240|NCT01750346|B4|Baseline|Total|Total of all reporting groups
107241|NCT01750346|B3|Baseline|Placebo|Participants in the Placebo arm received the placebo.
107242|NCT01750346|B2|Baseline|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107243|NCT01750346|B1|Baseline|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107244|NCT01750346|P3|Participant Flow|Placebo|Participants in the Placebo arm received the placebo.
107245|NCT01750346|P2|Participant Flow|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107246|NCT01750346|P1|Participant Flow|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107247|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
107248|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107249|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107250|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
107251|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107252|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107253|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
107254|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107255|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107256|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
107257|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107258|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107259|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
107260|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107261|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107262|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
107263|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107264|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
107265|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
107270|NCT01750346|E1|Reported Event|0.05% AH-8|"Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
Topical acetyl hexapeptide-8"
107271|NCT01750294|B1|Baseline|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
107272|NCT01750294|P1|Participant Flow|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
107273|NCT01750294|O1|Outcome|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
107274|NCT01750294|E1|Reported Event|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
107275|NCT01750281|B4|Baseline|Total|Total of all reporting groups
107276|NCT01750281|B3|Baseline|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
107277|NCT01750281|B2|Baseline|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
107278|NCT01750281|B1|Baseline|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
107279|NCT01750281|P3|Participant Flow|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
107280|NCT01750281|P2|Participant Flow|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
107281|NCT01750281|P1|Participant Flow|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
107282|NCT01750281|O3|Outcome|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
107288|NCT01750281|E3|Reported Event|Selumetinib 75 mg BD + Docetaxel 75 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
107289|NCT01750281|E2|Reported Event|Selumetinib 75 mg BD + Docetaxel 60 mg/m^2|Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
107290|NCT01750281|E1|Reported Event|Placebo + Docetaxel 75 mg/m^2|Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
107291|NCT01750255|B3|Baseline|Total|Total of all reporting groups
107292|NCT01750255|B2|Baseline|Pharmaceutical Care|Patients and families will be provided with verbal and written information and education about mental health and bipolar disorder. Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment. Pharmaceutical Care: Patients and their families will be provided with verbal and written information and education about mental health and bipolar disorder.
107293|NCT01750255|B1|Baseline|Control|"There is no placebo treatment, and after randomization, patients were informed of their group assignments. The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
Education: The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families."
107294|NCT01750255|P2|Participant Flow|Intervention Group: the Dader Method for Pharmaceutical Care|The Dader Method for pharmaceutical care is a systematic process developed by the Research Group of Pharmaceutical Care at the University of Granada, Spain [16]. The intervention is based on the use of pharmacotherapy records, evaluation of an assessment form that includes BD-I and the drugs used to treat this medical problem, and their assessment on a specific date. This assessment is used to identify: (1) any potential or actual patient health outcomes that are not consistent with the objectives of pharmacotherapy and are associated with the use of medicines (negative outcomes associated with medication (NOM)); and (2) situations in which the use of medicines caused or may cause the appearance of a NOM (drug-related problems (DRP)) [14]. Once the relevant problems are identified, the necessary interventions to patients or to physicians are carried out to solve the identified NOM and are followed by a subsequent assessment of the achieved outcomes.
107295|NCT01750255|P1|Participant Flow|Control: Usual Care (Routine Dispensing), Verbal and Written|Because there is no blinding, there is no ‘placebo’ treatment. Patients who meet the inclusion criteria will be informed about the study and they will be registered after their signed authorization. The control group (patients and their families) will receive usual care as well as verbal and written information provided by the pharmacist (routine dispensing, including oral counseling regarding drugs). The written material is about mental health (MH) and BD, with information focusing on the importance of adhering to pharmacological and non-pharmacological interventions to achieve treatment goals. Randomization will take place during week zero (baseline) and patients will meet again with the pharmacist every three months (3, 6, 9, and 12 months). At each appointment, variables related to the primary (number of hospitalizations, emergency service consultations, unscheduled outpatient visits) and secondary outcomes (effectiveness, safety, adherence, and quality of life) will be assessed.
107296|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
107297|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
107298|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
107299|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
107397|NCT01748799|O3|Outcome|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
107300|NCT01750255|O2|Outcome|Pharmaceutical Care|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
107301|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
107302|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
107303|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
107304|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
107305|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
107335|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily
Choline bitartrate"
107336|NCT01749982|O1|Outcome|Placebo|"Placebo tablets
Placebo"
107337|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine"
107338|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily
Betaine"
107339|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily
Choline bitartrate"
107306|NCT01750255|O2|Outcome|Pharmaceutical Care|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
107307|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
107308|NCT01750255|E2|Reported Event|Pharmaceutical Care|Patients and families will be provided with verbal and written information and education about mental health and bipolar disorder. Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
107352|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
107353|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
107309|NCT01750255|E1|Reported Event|Control|"The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
Education: The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure d"
107310|NCT01750242|B1|Baseline|Subjects With Advanced Parkinson's Disease|Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off.
107311|NCT01750242|P1|Participant Flow|PD Patients Implanted With DBS System|Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus who consented for the study.
107312|NCT01750242|O1|Outcome|Subjects With Advanced Parkinson's Disease|Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off.
107313|NCT01750242|O1|Outcome|PD Patients Implanted With DBS System|Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus and with readable images.
107314|NCT01750242|E1|Reported Event|Subjects With Advanced Parkinson's Disease|The study protocol did not require safety data to be collected for the study.
107315|NCT01750086|B3|Baseline|Total|Total of all reporting groups
107316|NCT01750086|B2|Baseline|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection"
107317|NCT01750086|B1|Baseline|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection"
107318|NCT01750086|P2|Participant Flow|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection"
107319|NCT01750086|P1|Participant Flow|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection"
107320|NCT01750086|O2|Outcome|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection"
107321|NCT01750086|O1|Outcome|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection"
107322|NCT01750086|E2|Reported Event|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection"
107323|NCT01750086|E1|Reported Event|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection"
107324|NCT01749982|B5|Baseline|Total|Total of all reporting groups
107325|NCT01749982|B4|Baseline|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine"
107326|NCT01749982|B3|Baseline|Betaine|"Betaine 1000 mg by mouth daily
Betaine"
107327|NCT01749982|B2|Baseline|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily
Choline bitartrate"
107328|NCT01749982|B1|Baseline|Placebo|"Placebo tablets
Placebo"
107329|NCT01749982|P4|Participant Flow|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine"
107330|NCT01749982|P3|Participant Flow|Betaine|"Betaine 1000 mg by mouth daily
Betaine"
107331|NCT01749982|P2|Participant Flow|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily
Choline bitartrate"
107332|NCT01749982|P1|Participant Flow|Placebo|"Placebo tablets
Placebo"
107333|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine"
107334|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily
Betaine"
107343|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily
Choline bitartrate"
107344|NCT01749982|O1|Outcome|Placebo|"Placebo tablets
Placebo"
107345|NCT01749982|E4|Reported Event|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine"
107346|NCT01749982|E3|Reported Event|Betaine|"Betaine 1000 mg by mouth daily
Betaine"
107347|NCT01749982|E2|Reported Event|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily
Choline bitartrate"
107348|NCT01749982|E1|Reported Event|Placebo|"Placebo tablets
Placebo"
107349|NCT01749956|B1|Baseline|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
107350|NCT01749956|P1|Participant Flow|FOLFOX6/Aflibercept/Radation/Surgery|"Preoperative Chemoradiation (6 weeks): 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IV), Days 1-42; Radiation: 50.4 Gy (1.8 Gy/day) Mon-Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.
Surgery (6 weeks from last dose of aflibercep): abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.
Postoperative Chemotherapy and Aflibercept: Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour; Days 1 and 15 of each 28-day cycle; Modified FOLFOX6: Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle."
107351|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
107395|NCT01748799|O5|Outcome|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
107354|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
107355|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
107356|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
107357|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
107358|NCT01749956|E1|Reported Event|FOLFOX6/Aflibercept/Radiation/Surgery|"Preoperative Chemoradiation: 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IVCI), Days 1 thru 42; Radiation: 50.4 Gy (1.8 Gy/day or 28 fractions) Mon thru Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.
Surgery: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.
Postoperative Chemotherapy and Aflibercept Treatments:
Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour (no more than 2 hours) on Days 1 and 15 of each cycle.
Modified FOLFOX6:
Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.
Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.
5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle.
Radiation
Aflibercept
Surgery: Abdominoperineal or low anterior resectio"
107359|NCT01748799|B9|Baseline|Total|Total of all reporting groups
107360|NCT01748799|B8|Baseline|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
107361|NCT01748799|B7|Baseline|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
107362|NCT01748799|B6|Baseline|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
107363|NCT01748799|B5|Baseline|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
107364|NCT01748799|B4|Baseline|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
107365|NCT01748799|B3|Baseline|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
107366|NCT01748799|B2|Baseline|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
107367|NCT01748799|B1|Baseline|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
107368|NCT01748799|P8|Participant Flow|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
107369|NCT01748799|P7|Participant Flow|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
107370|NCT01748799|P6|Participant Flow|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
107371|NCT01748799|P5|Participant Flow|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
107372|NCT01748799|P4|Participant Flow|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
107373|NCT01748799|P3|Participant Flow|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
107374|NCT01748799|P2|Participant Flow|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
107375|NCT01748799|P1|Participant Flow|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
107376|NCT01748799|O8|Outcome|Smoke as Usual StP|Smoke as usual condition corresponding to Self-titrated Placebo
107377|NCT01748799|O7|Outcome|Self-titrated Placebo|Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
107378|NCT01748799|O6|Outcome|Smoke as Usual FP|Smoke as usual condition corresponding to Fixed Placebo
107379|NCT01748799|O5|Outcome|Fixed Dose Placebo|Participants were requested to abstain from using cannabis and administer a fixed dose of placebo daily (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
107380|NCT01748799|O4|Outcome|Smoke as Usual StS|Smoke as usual condition corresponding to Self-titrated Sativex
107381|NCT01748799|O3|Outcome|Self-titrated Sativex|Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
107382|NCT01748799|O2|Outcome|Smoke as Usual FS|Smoke as usual condition corresponding to Fixed Sativex
107383|NCT01748799|O1|Outcome|Fixed Dose Sativex|Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
107384|NCT01748799|O8|Outcome|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
107385|NCT01748799|O7|Outcome|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
107386|NCT01748799|O6|Outcome|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
107387|NCT01748799|O5|Outcome|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
107388|NCT01748799|O4|Outcome|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
107389|NCT01748799|O3|Outcome|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
107390|NCT01748799|O2|Outcome|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
107391|NCT01748799|O1|Outcome|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
107392|NCT01748799|O8|Outcome|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
107393|NCT01748799|O7|Outcome|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
107394|NCT01748799|O6|Outcome|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
107398|NCT01748799|O2|Outcome|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
107399|NCT01748799|O1|Outcome|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
107400|NCT01748799|E8|Reported Event|Smoke as Usual StP|Smoke as usual condition corresponding to Self-titrated placebo
107401|NCT01748799|E7|Reported Event|Self-titrated Placebo|Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
107402|NCT01748799|E6|Reported Event|Smoke as Usual FP|Smoke as usual condition corresponding to Fixed placebo
107403|NCT01748799|E5|Reported Event|Fixed Dose Placebo|Participants were requested to abstain from using cannabis and take a fixed dose of placebo during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
107404|NCT01748799|E4|Reported Event|Smoke as Usual StS|Smoke as usual condition corresponding to Self-titrated Sativex
107405|NCT01748799|E3|Reported Event|Self-titrated Sativex|Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
107406|NCT01748799|E2|Reported Event|Smoke as Usual FS|Smoke as usual condition corresponding to Fixed Sativex
107407|NCT01748799|E1|Reported Event|Fixed Dose Sativex|Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
107408|NCT01748760|B3|Baseline|Total|Total of all reporting groups
107409|NCT01748760|B2|Baseline|Treatment as Usual|"Adolescent participants and parents will not receive study intervention
Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
107410|NCT01748760|B1|Baseline|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.
CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
107411|NCT01748760|P2|Participant Flow|Treatment as Usual|"Adolescent participants and parents will not receive study intervention
Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
107412|NCT01748760|P1|Participant Flow|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.
CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
107413|NCT01748760|O2|Outcome|Treatment as Usual|"Adolescent participants and parents will not receive study intervention
Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
107414|NCT01748760|O1|Outcome|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.
CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
107415|NCT01748760|E2|Reported Event|Treatment as Usual|"Adolescent participants and parents will not receive study intervention
Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
107965|NCT01746784|O2|Outcome|5mg/N6022|"N6022 by IV infusion once per day for 7 days
N6022: Intravenous solution of N6022 in normal saline"
107416|NCT01748760|E1|Reported Event|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.
CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
107417|NCT01749800|B4|Baseline|Total|Total of all reporting groups
107418|NCT01749800|B3|Baseline|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.
Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
107419|NCT01749800|B2|Baseline|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.
GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
107420|NCT01749800|B1|Baseline|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.
GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
107421|NCT01749800|P3|Participant Flow|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.
Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
107422|NCT01749800|P2|Participant Flow|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.
GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
107423|NCT01749800|P1|Participant Flow|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.
GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
107424|NCT01749800|O3|Outcome|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.
Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
107425|NCT01749800|O2|Outcome|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.
GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
107426|NCT01749800|O1|Outcome|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.
GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
107427|NCT01749800|E3|Reported Event|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.
Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
107428|NCT01749800|E2|Reported Event|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.
GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
107966|NCT01746784|O1|Outcome|Normal Saline|Placebo will receive IV normal saline Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl
107429|NCT01749800|E1|Reported Event|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.
GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
107430|NCT01749735|B3|Baseline|Total|Total of all reporting groups
107431|NCT01749735|B2|Baseline|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
107432|NCT01749735|B1|Baseline|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
107433|NCT01749735|P2|Participant Flow|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
107434|NCT01749735|P1|Participant Flow|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
107461|NCT01749501|B2|Baseline|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
107462|NCT01749501|B1|Baseline|Rocorium|"0.6 mg/kg once
Rocuronium: 0.6 mg/Kg once"
107463|NCT01749501|P2|Participant Flow|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
107435|NCT01749735|O2|Outcome|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
107436|NCT01749735|O1|Outcome|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
107437|NCT01749735|O2|Outcome|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
107438|NCT01749735|O1|Outcome|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
107439|NCT01749735|E2|Reported Event|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
107440|NCT01749735|E1|Reported Event|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
107441|NCT01749631|B1|Baseline|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
107442|NCT01749631|P1|Participant Flow|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
107443|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
107444|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
107445|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
107446|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
107447|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
107448|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
107449|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
107450|NCT01749631|E1|Reported Event|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
107451|NCT01749605|B3|Baseline|Total|Total of all reporting groups
107452|NCT01749605|B2|Baseline|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
107453|NCT01749605|B1|Baseline|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
107454|NCT01749605|P2|Participant Flow|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
107455|NCT01749605|P1|Participant Flow|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
107456|NCT01749605|O2|Outcome|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
107457|NCT01749605|O1|Outcome|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
107458|NCT01749605|E2|Reported Event|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
107459|NCT01749605|E1|Reported Event|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
107460|NCT01749501|B3|Baseline|Total|Total of all reporting groups
107471|NCT01749410|B1|Baseline|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
107472|NCT01749410|P1|Participant Flow|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
107473|NCT01749410|O1|Outcome|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
107474|NCT01749410|E1|Reported Event|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
107475|NCT01748955|B3|Baseline|Total|Total of all reporting groups
107476|NCT01748955|B2|Baseline|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.
Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
107477|NCT01748955|B1|Baseline|Bupropion|"Participants will receive bupropion XL for 8 weeks.
Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
107478|NCT01748955|P2|Participant Flow|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.
Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
107479|NCT01748955|P1|Participant Flow|Bupropion|"Participants will receive bupropion XL for 8 weeks.
Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
107480|NCT01748955|O2|Outcome|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.
Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
107481|NCT01748955|O1|Outcome|Bupropion|"Participants will receive bupropion XL for 8 weeks.
Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
107482|NCT01748955|O2|Outcome|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.
Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
107483|NCT01748955|O1|Outcome|Bupropion|"Participants will receive bupropion XL for 8 weeks.
Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
107484|NCT01748955|E2|Reported Event|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.
Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
107485|NCT01748955|E1|Reported Event|Bupropion|"Participants will receive bupropion XL for 8 weeks.
Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
107487|NCT01748916|P6|Participant Flow|Carrot-Tomato-Papaya|"Test meals were consumed in the following order: 1. Carrot 2. Tomato 3. Papaya
Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
107488|NCT01748916|P5|Participant Flow|Carrot-Papaya-Tomato|"Test meals were consumed in the following order: 1. Carrot 2. Papaya 3. Tomato
Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
107489|NCT01748916|P4|Participant Flow|Tomato-Carrot-Papaya|"Test meals were consumed in the following order: 1. Tomato 2. Carrot 3. Papaya
Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
107490|NCT01748916|P3|Participant Flow|Tomato-Papaya-Carrot|"Test meals were consumed in the following order: 1. Tomato 2. Papaya 3. Carrot
Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
107491|NCT01748916|P2|Participant Flow|Papaya-Tomato-Carrot|"Test meals were consumed in the following order: 1. Papaya 2. Tomato 3. Carrot
Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
107492|NCT01748916|P1|Participant Flow|Papaya-Carrot-Tomato|"Test meals were consumed in the following order: 1. Papaya 2. Carrot 3. Tomato.
Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
107493|NCT01748916|O5|Outcome|Lycopene Absorption From Tomato|
107494|NCT01748916|O4|Outcome|Lycopene Absorption From Papaya|
107495|NCT01748916|O3|Outcome|Beta-Carotene Absorption From Carrot|
107496|NCT01748916|O2|Outcome|Beta-Carotene Absorption From Tomato|
107499|NCT01748890|B1|Baseline|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
107500|NCT01748890|P1|Participant Flow|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
107501|NCT01748890|O1|Outcome|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
107502|NCT01748890|E1|Reported Event|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
107503|NCT01748695|B1|Baseline|V158866 and Placebo|Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks or vice versa
107504|NCT01748695|P2|Participant Flow|V158866 Followed by Placebo|V158866 450mg once per day for 4 weeks followed by placebo once per day for 4 weeks
107505|NCT01748695|P1|Participant Flow|Placebo Followed by V158866|Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
107506|NCT01748695|O2|Outcome|V158866|V158866 450mg once per day for 4 weeks
107507|NCT01748695|O1|Outcome|Placebo|Placebo once per day for 4 weeks
107508|NCT01748695|O2|Outcome|V158866|V158866 450mg once per day for 4 weeks
107509|NCT01748695|O1|Outcome|Placebo|Placebo once per day for 4 weeks
107510|NCT01748695|E2|Reported Event|V158866|V158866 450mg once per day for 4 Weeks
107511|NCT01748695|E1|Reported Event|Placebo|Placebo once per day for 4 weeks
107512|NCT01748643|B3|Baseline|Total|Total of all reporting groups
107513|NCT01748643|B2|Baseline|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
107514|NCT01748643|B1|Baseline|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
107515|NCT01748643|P2|Participant Flow|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
107516|NCT01748643|P1|Participant Flow|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
107517|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
107518|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
107561|NCT01748071|E3|Reported Event|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
107562|NCT01748071|E2|Reported Event|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
107519|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
107520|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
107521|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
107522|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
107523|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
107812|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
107524|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
107525|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
107526|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
107527|NCT01748643|O2|Outcome|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
107528|NCT01748643|O1|Outcome|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
107529|NCT01748643|E2|Reported Event|Normal Neuromuscular Blockade, Reversal With Neostigmine|"After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.
normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9."
107530|NCT01748643|E1|Reported Event|Deep Neuromuscular Blockade, Reversal With Sugammadex|"a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.
deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9."
107531|NCT01748227|B1|Baseline|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain
Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
107532|NCT01748227|P1|Participant Flow|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain
Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
107533|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans
Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
107534|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans
Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
107535|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans
Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
107536|NCT01748227|O1|Outcome|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain
Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
107537|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans
Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
107599|NCT01747928|P3|Participant Flow|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107538|NCT01748227|E1|Reported Event|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain
Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
107539|NCT01748071|B4|Baseline|Total|Total of all reporting groups
107540|NCT01748071|B3|Baseline|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
107541|NCT01748071|B2|Baseline|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
107542|NCT01748071|B1|Baseline|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
107543|NCT01748071|P3|Participant Flow|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
107544|NCT01748071|P2|Participant Flow|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
107545|NCT01748071|P1|Participant Flow|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
107546|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
107547|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
107548|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
107549|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
107550|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
107551|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
107552|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
107553|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
107554|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
107555|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
107556|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
107557|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
107558|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
107559|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
107560|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
107563|NCT01748071|E1|Reported Event|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
107564|NCT01748045|B3|Baseline|Total|Total of all reporting groups
107565|NCT01748045|B2|Baseline|Nitrogen Gas|"Placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas"
107566|NCT01748045|B1|Baseline|Inhaled Nitric Oxide|"iNO to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide"
107567|NCT01748045|P2|Participant Flow|Nitrogen Gas|"Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas"
107568|NCT01748045|P1|Participant Flow|Inhaled Nitric Oxide (iNO)|"Number of participants who have started on iNO at 20 parts per million (ppm) for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide"
107569|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas"
107570|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide"
107571|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas"
107572|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide"
107573|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas"
107574|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide"
107575|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose were then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas"
107576|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose were then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide"
107577|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas which was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas"
107578|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide"
107579|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas"
107580|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide"
107581|NCT01748045|O2|Outcome|Nitrogen Gas|"Number of participants who were started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas"
107582|NCT01748045|O1|Outcome|Inhaled Nitric Oxide|"Number of participants who were started on inhaled Nitric Oxide (iNO) at 20 parts per million (ppm) for the first three days of life. The dose was then decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide"
107583|NCT01748045|E2|Reported Event|Nitrogen Gas|"Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas"
107584|NCT01748045|E1|Reported Event|Inhaled Nitric Oxide|"Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide"
107585|NCT01747928|B9|Baseline|Total|Total of all reporting groups
108186|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
107586|NCT01747928|B8|Baseline|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107587|NCT01747928|B7|Baseline|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107588|NCT01747928|B6|Baseline|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107589|NCT01747928|B5|Baseline|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107590|NCT01747928|B4|Baseline|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107591|NCT01747928|B3|Baseline|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107592|NCT01747928|B2|Baseline|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107593|NCT01747928|B1|Baseline|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107594|NCT01747928|P8|Participant Flow|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107595|NCT01747928|P7|Participant Flow|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107596|NCT01747928|P6|Participant Flow|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107597|NCT01747928|P5|Participant Flow|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107598|NCT01747928|P4|Participant Flow|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107600|NCT01747928|P2|Participant Flow|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107601|NCT01747928|P1|Participant Flow|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107602|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107603|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107604|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107605|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107606|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107607|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107608|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107609|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107610|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107611|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107612|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107613|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107614|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107615|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107616|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107617|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107618|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107619|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107620|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107621|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107622|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107623|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107624|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107625|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107626|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107627|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107628|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107629|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107630|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107631|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107632|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107633|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107634|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107635|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107636|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107637|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107638|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107639|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107640|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107641|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107642|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107643|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107644|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107645|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107646|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107647|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107648|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107649|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107650|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107651|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107652|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107653|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107654|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107655|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107656|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107657|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107658|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107659|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107660|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107661|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107662|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107663|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107664|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107665|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107666|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107667|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107668|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107669|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107670|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107671|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107672|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107673|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107674|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107675|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107676|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107677|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107678|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107679|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107680|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107681|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107682|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107683|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107684|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107685|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107686|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107687|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107688|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107689|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107690|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107691|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107692|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107693|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107694|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107695|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107696|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107697|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107698|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107699|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107700|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107701|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107702|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107703|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107704|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107705|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107706|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107707|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107708|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107709|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107710|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107711|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107712|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107713|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107714|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107715|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107716|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107717|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107718|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107719|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107720|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107721|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107722|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107723|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107724|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107725|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107726|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107727|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107728|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107729|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107730|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107731|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107732|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107733|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107734|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107735|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107736|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107737|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107738|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107739|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107740|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107741|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107742|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107743|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107744|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107745|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107746|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107747|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107748|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107749|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107750|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107751|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107752|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107753|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107754|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107755|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107756|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107757|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107758|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107759|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107760|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107761|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107762|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107763|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107764|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107765|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107766|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107767|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107768|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107769|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107770|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107771|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107772|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107773|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107774|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107775|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107776|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107777|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107778|NCT01747928|O9|Outcome|All Participants|All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
107779|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107780|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107781|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107782|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107783|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107784|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107785|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107786|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107787|NCT01747928|O9|Outcome|All Participants|All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
107788|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107789|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107790|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107791|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107792|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107793|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
108312|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
107794|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107795|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107796|NCT01747928|E8|Reported Event|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107797|NCT01747928|E7|Reported Event|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107798|NCT01747928|E6|Reported Event|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107799|NCT01747928|E5|Reported Event|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107800|NCT01747928|E4|Reported Event|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107801|NCT01747928|E3|Reported Event|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107802|NCT01747928|E2|Reported Event|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107803|NCT01747928|E1|Reported Event|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
107804|NCT01747811|B3|Baseline|Total|Total of all reporting groups
107805|NCT01747811|B2|Baseline|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
107806|NCT01747811|B1|Baseline|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
107807|NCT01747811|P2|Participant Flow|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
107808|NCT01747811|P1|Participant Flow|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
107809|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
107810|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
107811|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
107813|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks
wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
107814|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
107815|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
107816|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
107817|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks
wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
107818|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
107819|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
107820|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
107821|NCT01747811|E2|Reported Event|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
107822|NCT01747811|E1|Reported Event|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
107823|NCT01747772|B1|Baseline|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
107824|NCT01747772|P1|Participant Flow|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
107825|NCT01747772|O5|Outcome|Fibrosis 4|Participants with cirrhosis on liver biopsy evaluation.
107826|NCT01747772|O4|Outcome|Fibrosis 3|Participants with numerous septa without cirrhosis on liver biopsy evaluation.
107827|NCT01747772|O3|Outcome|Fibrosis 2|Participants with portal fibrosis with few septa on liver biopsy evaluation.
107828|NCT01747772|O2|Outcome|Fibrosis 1|Participants with portal fibrosis without septa on liver biopsy evaluation.
107829|NCT01747772|O1|Outcome|Fibrosis 0|Participants with no fibrosis on liver biopsy evaluation.
107830|NCT01747772|E1|Reported Event|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
107831|NCT01747655|B1|Baseline|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107832|NCT01747655|P2|Participant Flow|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
107833|NCT01747655|P1|Participant Flow|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107834|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107835|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107836|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107837|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107838|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107839|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
107840|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107841|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
107842|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107843|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
107844|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107845|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
107846|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107847|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
107848|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107849|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
107850|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107851|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
107852|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107853|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107854|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107855|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications.
107856|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107857|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
107858|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
107859|NCT01747655|E1|Reported Event|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy
107860|NCT01747629|B3|Baseline|Total|Total of all reporting groups
107861|NCT01747629|B2|Baseline|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107862|NCT01747629|B1|Baseline|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107863|NCT01747629|P2|Participant Flow|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107864|NCT01747629|P1|Participant Flow|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107865|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107866|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107867|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107868|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107869|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107870|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107871|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107872|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107873|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107874|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107875|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107876|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107877|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107878|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107879|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107880|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107881|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107882|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107883|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107884|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107885|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107886|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107887|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107888|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107889|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107890|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107891|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107892|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107893|NCT01747629|E2|Reported Event|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
107894|NCT01747629|E1|Reported Event|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
107895|NCT01747343|B1|Baseline|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
107896|NCT01747343|P1|Participant Flow|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
107897|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
107898|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
107899|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
107900|NCT01747343|E1|Reported Event|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
107901|NCT01747330|B1|Baseline|Creon Micro, Minimicrospheres|Pancreatin: Doses of pancreatin <2500 lipase u/kg/feed or <4000 lipase u/g fat/intake or <10000 lipase u/kg/day given orally are used
107902|NCT01747330|P1|Participant Flow|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
107903|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
107904|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
107905|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
107906|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
107907|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
108313|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
107908|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
107909|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
107910|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
107911|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
107912|NCT01747330|E1|Reported Event|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
107913|NCT01746940|B5|Baseline|Total|Total of all reporting groups
107914|NCT01746940|B4|Baseline|Not Randomized|Enrolled subjects who are not randomized to treatment due to early withdrawal from the study
107915|NCT01746940|B3|Baseline|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
107916|NCT01746940|B2|Baseline|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
107917|NCT01746940|B1|Baseline|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
107918|NCT01746940|P4|Participant Flow|Not Randomized|Enrolled subjects who are not randomized to treatment due to early withdrawal from the study
107919|NCT01746940|P3|Participant Flow|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
107920|NCT01746940|P2|Participant Flow|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
107921|NCT01746940|P1|Participant Flow|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
107922|NCT01746940|O3|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
107923|NCT01746940|O2|Outcome|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
107924|NCT01746940|O1|Outcome|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
107925|NCT01746940|E3|Reported Event|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
107926|NCT01746940|E2|Reported Event|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
107927|NCT01746940|E1|Reported Event|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
107928|NCT01746862|B3|Baseline|Total|Total of all reporting groups
107929|NCT01746862|B2|Baseline|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107930|NCT01746862|B1|Baseline|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
107931|NCT01746862|P2|Participant Flow|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107932|NCT01746862|P1|Participant Flow|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
107933|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107934|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107935|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107936|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
107937|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107938|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
107939|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107940|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
107941|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107942|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
107943|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107944|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
107945|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107946|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
107947|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107948|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
107949|NCT01746862|E2|Reported Event|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
107950|NCT01746862|E1|Reported Event|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
107951|NCT01746784|B6|Baseline|Total|Total of all reporting groups
107952|NCT01746784|B5|Baseline|40mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107953|NCT01746784|B4|Baseline|20mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107954|NCT01746784|B3|Baseline|10mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107955|NCT01746784|B2|Baseline|5mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107956|NCT01746784|B1|Baseline|Normal Saline|Normal saline: IV solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
107957|NCT01746784|P5|Participant Flow|40 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
107958|NCT01746784|P4|Participant Flow|20mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
107959|NCT01746784|P3|Participant Flow|10 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
107960|NCT01746784|P2|Participant Flow|5 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
107961|NCT01746784|P1|Participant Flow|Placebo/Saline|0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
107962|NCT01746784|O5|Outcome|40mg/N6022|"N6022 by IV infusion once per day for 7 days
N6022 in normal saline administered by infusion pump over 1-8 minutes"
107963|NCT01746784|O4|Outcome|20mg/N6022|"N6022 by IV infusion once per day for 7 days
N6022: Intravenous solution of N6022 in normal saline"
107964|NCT01746784|O3|Outcome|10mg/N6022|"N6022 by IV infusion once per day for 7 days
N6022: Intravenous solution of N6022 in normal saline"
107967|NCT01746784|O5|Outcome|40mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107968|NCT01746784|O4|Outcome|20mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107969|NCT01746784|O3|Outcome|10mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107970|NCT01746784|O2|Outcome|5mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107971|NCT01746784|O1|Outcome|Normal Saline|Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
107972|NCT01746784|O5|Outcome|40mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107973|NCT01746784|O4|Outcome|20mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107974|NCT01746784|O3|Outcome|10mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107975|NCT01746784|O2|Outcome|5mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
107976|NCT01746784|O1|Outcome|Normal Saline|Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
107977|NCT01746784|E5|Reported Event|40 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
107978|NCT01746784|E4|Reported Event|20mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
107979|NCT01746784|E3|Reported Event|10 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
107980|NCT01746784|E2|Reported Event|5 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
107981|NCT01746784|E1|Reported Event|Placebo/Saline|0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
107982|NCT01746511|B3|Baseline|Total|Total of all reporting groups
107983|NCT01746511|B2|Baseline|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
107984|NCT01746511|B1|Baseline|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our"
107985|NCT01746511|P2|Participant Flow|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
107986|NCT01746511|P1|Participant Flow|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
107987|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
108010|NCT01746264|B1|Baseline|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108011|NCT01746264|P1|Participant Flow|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108012|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108013|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108014|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
107988|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
107989|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
107990|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
107991|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
107992|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
107993|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
107994|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
107995|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
108015|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108016|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108017|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108018|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108019|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108020|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
107996|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
107997|NCT01746511|E2|Reported Event|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
107998|NCT01746511|E1|Reported Event|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our"
107999|NCT01746368|B3|Baseline|Total|Total of all reporting groups
108000|NCT01746368|B2|Baseline|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
108001|NCT01746368|B1|Baseline|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
108002|NCT01746368|P2|Participant Flow|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
108003|NCT01746368|P1|Participant Flow|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
108004|NCT01746368|O2|Outcome|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
108005|NCT01746368|O1|Outcome|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
108006|NCT01746368|O2|Outcome|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
108007|NCT01746368|O1|Outcome|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
108008|NCT01746368|E2|Reported Event|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
108009|NCT01746368|E1|Reported Event|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
108021|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108022|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108023|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108024|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108025|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108026|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108027|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108028|NCT01746264|E1|Reported Event|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
108029|NCT01746173|B1|Baseline|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
108030|NCT01746173|P1|Participant Flow|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
108125|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108031|NCT01746173|O1|Outcome|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
108032|NCT01746173|O1|Outcome|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
108033|NCT01746173|E1|Reported Event|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
108034|NCT01746108|B4|Baseline|Total|Total of all reporting groups
108035|NCT01746108|B3|Baseline|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108098|NCT01745952|E3|Reported Event|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
sham rTMS coil (figure-of-eight): placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue"
108144|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108036|NCT01746108|B2|Baseline|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108037|NCT01746108|B1|Baseline|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108038|NCT01746108|P3|Participant Flow|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108085|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
108039|NCT01746108|P2|Participant Flow|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108040|NCT01746108|P1|Participant Flow|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108041|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108042|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108043|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108044|NCT01746108|O3|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108045|NCT01746108|O2|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108046|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108047|NCT01746108|O3|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108048|NCT01746108|O2|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108049|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108050|NCT01746108|O1|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
108051|NCT01746108|O2|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
108052|NCT01746108|O1|Outcome|Synflorix AR-PR-5-17Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 5 and 17 years.
108053|NCT01746108|O2|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
108054|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108055|NCT01746108|O3|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
108056|NCT01746108|O2|Outcome|Synflorix AR-PR-2-4Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 24 and 59 months.
108057|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108058|NCT01746108|O1|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
108059|NCT01746108|O2|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
108060|NCT01746108|O1|Outcome|Synflorix AR-PR-5-17Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 5 and 17 years.
108061|NCT01746108|O2|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
108062|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108063|NCT01746108|O3|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
108064|NCT01746108|O2|Outcome|Synflorix AR-PR-2-4Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 24 and 59 months.
108065|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108086|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
108087|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
108066|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108067|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108068|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108069|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108070|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108071|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
109120|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service
rapid access to contraceptive service"
108072|NCT01746108|E3|Reported Event|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108073|NCT01746108|E2|Reported Event|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
108314|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108074|NCT01746108|E1|Reported Event|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.
*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
108075|NCT01745952|B1|Baseline|All Participants|description of the patients at the onset of the study
108076|NCT01745952|P3|Participant Flow|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period"
108077|NCT01745952|P2|Participant Flow|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period"
108078|NCT01745952|P1|Participant Flow|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period"
108079|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
108080|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
108081|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
108082|NCT01745952|O3|Outcome|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period"
108099|NCT01745952|E2|Reported Event|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
round active rTMS coil: navigated rTMS over epileptogenic focus using round active rTMS coil"
108145|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108083|NCT01745952|O2|Outcome|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period"
108084|NCT01745952|O1|Outcome|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period"
108088|NCT01745952|O1|Outcome|Any Difference Between the Four Conditions|effect of baseline/ figure-of-eight/ round/ sham treatment period on the seizure frequency of the patients
108089|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
108090|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
108091|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
108092|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered"
108093|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered"
108094|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
108095|NCT01745952|O3|Outcome|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period"
108096|NCT01745952|O2|Outcome|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period"
108097|NCT01745952|O1|Outcome|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period
rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
12 week follow-up period"
108100|NCT01745952|E1|Reported Event|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
figure-of-eight active rTMS coil: navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil"
108101|NCT01745913|B3|Baseline|Total|Total of all reporting groups
108102|NCT01745913|B2|Baseline|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
108103|NCT01745913|B1|Baseline|Haplo-Cord SCT|The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
108104|NCT01745913|P2|Participant Flow|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1 Fludarabine: Fludarabine: 30 mg/m2 /day intravenously x 5 days total dose 150 mg/m2. Fludarabine will be dosed according to actual body weight Melphalan: Melphalan: 70mg/m2/day intravenously x 2 days. Melphalan will be dosed according to actual body weight.
108124|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108531|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108105|NCT01745913|P1|Participant Flow|Haplo-Cord SCT|"The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1
CliniMACS® CD34 Reagent System: If a subject is randomized to the haplo-cord transplant group, their family member will undergo a stem cell collection. The stem cells from the haplo-identical donor will be purified by a procedure called CD34 selection before they are given to the subject. A special device called the CliniMACS® CD34 Reagent System, which is not FDA approved, will be used for this purpose."
108106|NCT01745913|O2|Outcome|UCB SCT|"For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1
Fludarabine: Fludarabine: 30 mg/m2 /day intravenously x 5 days total dose 150 mg/m2. Fludarabine will be dosed according to actual body weight
Melphalan: Melphalan: 70mg/m2/day intravenously x 2 days. Melphalan will be dosed according to actual body weight. Cryotherapy with ice chips will be administered to prevent mucosit"
108107|NCT01745913|O1|Outcome|Haplo-Cord SCT|"The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1
CliniMACS® CD34 Reagent System: If a subject is randomized to the haplo-cord transplant group, their family member will undergo a stem cell collection. The stem cells from the haplo-identical donor will be purified by a procedure called CD34 selection before they are given to the subject. A special device called the CliniMACS® CD34 Reagent System, which is not FDA approved, will be used for this purpose. The manufacturer of the device, Miltenyi Biotec, is providing the researchers access to the device for"
108108|NCT01745913|O2|Outcome|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
108109|NCT01745913|O1|Outcome|Haplo-Cord SCT|The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
108110|NCT01745913|E2|Reported Event|UCB SCT|For the standard arm, UCB units will be selected using the Minnesota strategy and the strategy followed in a recent CTN study.17;19Each unit must supply a minimum of 1.5 x107/kg pre-cryopreserved nucleated cell dose. Subjects must have two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
108111|NCT01745913|E1|Reported Event|Haplo-Cord SCT|The UCB unit must supply a minimum of 1.0 x107/kg pre-cryopreserved nucleated cell dose. The unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0-2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and –B and at high resolution for –DRB1.
108112|NCT01745848|B1|Baseline|Roflumilast|Roflumilast 500 μcg, once daily, for 30 days
108113|NCT01745848|P1|Participant Flow|Roflumilast|"Roflumilast 500 μcg, once daily, for 30 days
Roflumilast"
108114|NCT01745848|O1|Outcome|Roflumilast|Roflumilast 500 μcg, once daily, for 30 days
108115|NCT01745848|O1|Outcome|Roflumilast|Roflumilast 500 μcg, once daily, for 30 days
108116|NCT01745848|E1|Reported Event|Roflumilast|Roflumilast 500 μcg, once daily, for 30 days
108117|NCT01745380|B3|Baseline|Total|Total of all reporting groups
108118|NCT01745380|B2|Baseline|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108119|NCT01745380|B1|Baseline|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108120|NCT01745380|P2|Participant Flow|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108121|NCT01745380|P1|Participant Flow|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108122|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108123|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108126|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108127|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108128|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108129|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108130|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108131|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108132|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108133|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108134|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108135|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108136|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108137|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108138|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108139|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108140|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108141|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108142|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108143|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108146|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108147|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108148|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108149|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108150|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108151|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108152|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108153|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108154|NCT01745380|E2|Reported Event|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo"
108155|NCT01745380|E1|Reported Event|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
108156|NCT01745133|B4|Baseline|Total|Total of all reporting groups
108157|NCT01745133|B3|Baseline|Calcipotriene + Clobetasol Propionate 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
108185|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108158|NCT01745133|B2|Baseline|Calcipotriene 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x
calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
108159|NCT01745133|B1|Baseline|Vehicle 19|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
108160|NCT01745133|P3|Participant Flow|Calcipotriene + Clobetasol Propionate 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
108161|NCT01745133|P2|Participant Flow|Calcipotriene 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x
calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
108162|NCT01745133|P1|Participant Flow|Vehicle 19|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
108163|NCT01745133|O3|Outcome|Calcipotriene + Clobetasol Propionate 79%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
108164|NCT01745133|O2|Outcome|Calcipotriene 80%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x
calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
108165|NCT01745133|O1|Outcome|Vehicle 68%|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
108166|NCT01745133|E3|Reported Event|Calcipotriene + Clobetasol Propionate 79%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
108167|NCT01745133|E2|Reported Event|Calcipotriene 80%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x
calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
108168|NCT01745133|E1|Reported Event|Vehicle|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
108169|NCT01745055|B1|Baseline|Methotrexate + CP-690,550|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108229|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
108170|NCT01745055|P1|Participant Flow|Methotrexate + CP-690,550|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108171|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108172|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
108173|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108174|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
108175|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108176|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
108177|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108178|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
108179|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108180|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
108181|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108182|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
108183|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108184|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
108187|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108188|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
108189|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108190|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
108191|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108192|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
108193|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108194|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
108195|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108196|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
108197|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108198|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
108199|NCT01745055|E3|Reported Event|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
108200|NCT01745055|E2|Reported Event|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
108201|NCT01745055|E1|Reported Event|Methotrexate|Single oral dose of MTX on Day 1 (15-25 mg), as per local prescribing practice.
108202|NCT01744977|B3|Baseline|Total|Total of all reporting groups
108203|NCT01744977|B2|Baseline|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
108204|NCT01744977|B1|Baseline|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.
packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
108205|NCT01744977|P2|Participant Flow|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
108262|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108206|NCT01744977|P1|Participant Flow|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA (Research Assistant) on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.
packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
108207|NCT01744977|O2|Outcome|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
108208|NCT01744977|O1|Outcome|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.
packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
108209|NCT01744977|O2|Outcome|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
108210|NCT01744977|O1|Outcome|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.
packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
108211|NCT01744977|E2|Reported Event|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
108315|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108212|NCT01744977|E1|Reported Event|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.
packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
108213|NCT01744860|B1|Baseline|Melanoma Tumor Sample With BRAF V600 Mutation|BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods and Cobas 4800 mutation test
108214|NCT01744860|P1|Participant Flow|Melanoma Tumor Sample With BRAF V600 Mutation|BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods and Cobas 4800 mutation test
108215|NCT01744860|O1|Outcome|Final Result- Discordant Samples|This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa “in House” Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome.
108216|NCT01744860|O1|Outcome|Discordant Group|This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa “in House” Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome.
108217|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
108218|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
108219|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
108220|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
108221|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
108222|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
108223|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
108224|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
108225|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
108226|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
108227|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
108228|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
108230|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
108231|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
108232|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
108233|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
108234|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
108235|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
108236|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
108237|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
108238|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
108239|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
108240|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
108316|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108241|NCT01744860|O1|Outcome|Overall Tumour Samples|A total of 420 melanoma samples (surgical specimens or biopsies of primary tumours or metastases) were included in analysis. The samples were collected either from External pathology laboratories or Internal pathology laboratories
108242|NCT01744860|O1|Outcome|Overall Tumour Samples|A total of 420 melanoma samples (surgical specimens or biopsies of primary tumours or metastases) were included in analysis. The samples were collected either from External pathology laboratories or Internal pathology laboratories
108243|NCT01744860|O2|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
108244|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
108245|NCT01744860|E2|Reported Event|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
108246|NCT01744860|E1|Reported Event|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using in-house methods
108247|NCT01744821|B5|Baseline|Total|Total of all reporting groups
108248|NCT01744821|B4|Baseline|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
108249|NCT01744821|B3|Baseline|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
108250|NCT01744821|B2|Baseline|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108251|NCT01744821|B1|Baseline|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108252|NCT01744821|P4|Participant Flow|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
108253|NCT01744821|P3|Participant Flow|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
108254|NCT01744821|P2|Participant Flow|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108255|NCT01744821|P1|Participant Flow|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108256|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
108257|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
108258|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108259|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108260|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
108261|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
108439|NCT01743521|B4|Baseline|No Group Allocated|Early treatment discontinuation or non-responder
108263|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108264|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
108265|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
108266|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108267|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108268|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
108269|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
108270|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108271|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108272|NCT01744821|E4|Reported Event|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
108273|NCT01744821|E3|Reported Event|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
108274|NCT01744821|E2|Reported Event|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108275|NCT01744821|E1|Reported Event|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
108276|NCT01744730|B6|Baseline|Total|Total of all reporting groups
108277|NCT01744730|B5|Baseline|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration
108278|NCT01744730|B4|Baseline|Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)|Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
108279|NCT01744730|B3|Baseline|Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)|Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
108280|NCT01744730|B2|Baseline|Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)|Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
108281|NCT01744730|B1|Baseline|Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)|Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
108282|NCT01744730|P5|Participant Flow|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration.
108283|NCT01744730|P4|Participant Flow|Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)|Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
108284|NCT01744730|P3|Participant Flow|Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)|Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
108285|NCT01744730|P2|Participant Flow|Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)|Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
108286|NCT01744730|P1|Participant Flow|Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)|Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
108287|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108288|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108289|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108290|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108291|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108292|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108293|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108294|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108295|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108296|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108297|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108298|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108299|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108300|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108301|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108302|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108303|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108304|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108305|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108306|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108307|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108308|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108309|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108310|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108311|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108317|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108318|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108319|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108320|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108321|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
108322|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
108323|NCT01744730|E5|Reported Event|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration
108324|NCT01744730|E4|Reported Event|Clindamycin IV-ages 12 to 17 (BMI Greater Than or Equal 95th)|"Clindamycin IV: Children ages 12 to 17 years old with BMI greater than or equal 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
108325|NCT01744730|E3|Reported Event|Clinidamycin IV-ages 12 to 17 (BMI 85- <95th Percentile)|"Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to <95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
108326|NCT01744730|E2|Reported Event|Clindamycin IV-ages 2 to 11 (BMI Greater Than or Equal 95th)|"Clindamycin IV: Children ages 2 to 11 years old with BMI greater than or equal 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
108327|NCT01744730|E1|Reported Event|Clindamycin IV-ages 2 to 11 (BMI 85- <95th Percentile)|"Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to <95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
108328|NCT01744691|B1|Baseline|PCI-32765|"All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
108329|NCT01744691|P1|Participant Flow|Ibrutinib|"All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
Ibrutinib: All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily."
108330|NCT01744691|O1|Outcome|PCI-32765|"All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
PCI-32765: All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
108331|NCT01744691|O1|Outcome|Ibrutinib|"All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
ibrutinib: All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily."
108332|NCT01744691|E1|Reported Event|PCI-32765|"All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
108333|NCT01744496|B3|Baseline|Total|Total of all reporting groups
108334|NCT01744496|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108335|NCT01744496|B1|Baseline|Placebo|"Placebo Transdermal Patches
Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108336|NCT01744496|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108361|NCT01744483|O3|Outcome|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
108337|NCT01744496|P1|Participant Flow|Placebo|"Placebo Transdermal Patches
Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108338|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108339|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108340|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108341|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108499|NCT01743092|P1|Participant Flow|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group
Tutuorial workbook: A work book about their addiciton"
108342|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108343|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108344|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108345|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108362|NCT01744483|O2|Outcome|PUC ETT|"Polyurethane cuff endotracheal tube
PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
108363|NCT01744483|O1|Outcome|PVC ETT|"Polyvinylchloride cuff endotracheal tube
PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
108529|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108346|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108347|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108348|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108349|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108350|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108351|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108352|NCT01744496|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108353|NCT01744496|E1|Reported Event|Placebo|"Placebo Transdermal Patches
Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
108354|NCT01744483|B4|Baseline|Total|Total of all reporting groups
108355|NCT01744483|B3|Baseline|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
108356|NCT01744483|B2|Baseline|PUC ETT|"Polyurethane cuff endotracheal tube
PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
108357|NCT01744483|B1|Baseline|PVC ETT|"Polyvinylchloride cuff endotracheal tube
PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
108358|NCT01744483|P3|Participant Flow|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
108359|NCT01744483|P2|Participant Flow|PUC ETT|"Polyurethane cuff endotracheal tube
PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
108360|NCT01744483|P1|Participant Flow|PVC ETT|"Polyvinylchloride cuff endotracheal tube
PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
108364|NCT01744483|E3|Reported Event|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
108365|NCT01744483|E2|Reported Event|PUC ETT|"Polyurethane cuff endotracheal tube
PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
108366|NCT01744483|E1|Reported Event|PVC ETT|"Polyvinylchloride cuff endotracheal tube
PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
108367|NCT01744392|B1|Baseline|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
108368|NCT01744392|P1|Participant Flow|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
108369|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
108500|NCT01743092|O2|Outcome|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.
Webinar: Some clients will receive a webinar as part of their treatment.
Tutuorial workbook: A work book about their addiciton"
108370|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
108371|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
108372|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
108384|NCT01744353|P3|Participant Flow|Experimental: Dose Level 3|Abraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
108385|NCT01744353|P2|Participant Flow|Experimental: Dose Level 2/ MTD|Abraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
108386|NCT01744353|P1|Participant Flow|Experimental: Dose Level 1|Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
108530|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108373|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
108374|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
108375|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
108376|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
108377|NCT01744392|O1|Outcome|Education Intervention|The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
108378|NCT01744392|O1|Outcome|Education Intervention|The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
108379|NCT01744392|E1|Reported Event|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.
education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
108380|NCT01744353|B4|Baseline|Total|Total of all reporting groups
108381|NCT01744353|B3|Baseline|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
108382|NCT01744353|B2|Baseline|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
108383|NCT01744353|B1|Baseline|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
108387|NCT01744353|O3|Outcome|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxan"
108388|NCT01744353|O2|Outcome|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
108389|NCT01744353|O1|Outcome|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
108390|NCT01744353|O3|Outcome|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxan"
108391|NCT01744353|O2|Outcome|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
108392|NCT01744353|O1|Outcome|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
108393|NCT01744353|E1|Reported Event|FOLFOX- A|"FOLFOX-A Dose levels -1, 1, 2, 3: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated. Once the MTD is found, the Principal Investigator will determine which dose should be assessed futher and an additional 10 patients will be treated.
FOLFOX-A: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue un"
108394|NCT01744340|B3|Baseline|Total|Total of all reporting groups
108395|NCT01744340|B2|Baseline|Colon- Closed as of May 2014|"Eribulin Mesylate:
1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle
Colon- Closed as of May 2014: Eribulin Mesylate:
1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
108396|NCT01744340|B1|Baseline|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2
Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter
Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
108397|NCT01744340|P2|Participant Flow|Colon- Closed as of May 2014|"Eribulin Mesylate:
1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle
Colon- Closed as of May 2014: Eribulin Mesylate:
1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
108501|NCT01743092|O1|Outcome|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group
Tutuorial workbook: A work book about their addiciton"
108398|NCT01744340|P1|Participant Flow|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2
Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter
Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
108399|NCT01744340|O2|Outcome|Colon- Closed as of May 2014|"Eribulin Mesylate:
1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle
Colon- Closed as of May 2014: Eribulin Mesylate:
1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
108400|NCT01744340|O1|Outcome|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2
Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter
Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
108401|NCT01744340|O2|Outcome|Colon- Closed as of May 2014|"Eribulin Mesylate:
1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle
Colon- Closed as of May 2014: Eribulin Mesylate:
1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
108402|NCT01744340|O1|Outcome|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2
Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter
Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
108403|NCT01744340|E2|Reported Event|Colon- Closed as of May 2014|"Eribulin Mesylate:
1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle
Colon- Closed as of May 2014: Eribulin Mesylate:
1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
108404|NCT01744340|E1|Reported Event|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2
Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter
Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
108405|NCT01744197|B3|Baseline|Total|Total of all reporting groups
108406|NCT01744197|B2|Baseline|Placebo First, Then Synera|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after).
108520|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108407|NCT01744197|B1|Baseline|Synera First, Then Placebo|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after).
108408|NCT01744197|P2|Participant Flow|Placebo First, Then Synera|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after).
108409|NCT01744197|P1|Participant Flow|Synera First, Then Placebo|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after).
108410|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
108411|NCT01744197|O1|Outcome|Synera|Treated with Synera.
108412|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
108413|NCT01744197|O1|Outcome|Synera|Treated with Synera.
108414|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
108415|NCT01744197|O1|Outcome|Synera|Treated with Synera.
108416|NCT01744197|E2|Reported Event|Placebo|Treated with Placebo
108417|NCT01744197|E1|Reported Event|Synera|Treated with Synera.
108418|NCT01743963|B3|Baseline|Total|Total of all reporting groups
108419|NCT01743963|B2|Baseline|Usual Care|"Clinicians' typical approach for GID monitoring
Usual Care: clinicians typical apporach for GID monitering"
108420|NCT01743963|B1|Baseline|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support
Decision support: Clinical pharmacists mediated computerized decision support"
108421|NCT01743963|P2|Participant Flow|Usual Care|"Clinicians' typical approach for GID monitoring
Usual Care: clinicians typical apporach for GID monitering"
108422|NCT01743963|P1|Participant Flow|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support
Decision support: Clinical pharmacists mediated computerized decision support"
108423|NCT01743963|O2|Outcome|Usual Care|"Clinicians' typical approach for GID monitoring
Usual Care: clinicians typical apporach for GID monitering"
108424|NCT01743963|O1|Outcome|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support
Decision support: Clinical pharmacists mediated computerized decision support"
108425|NCT01743963|E2|Reported Event|Usual Care|"Clinicians' typical approach for GID monitoring
Usual Care: clinicians typical apporach for GID monitering"
108426|NCT01743963|E1|Reported Event|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support
Decision support: Clinical pharmacists mediated computerized decision support"
108427|NCT01743729|B3|Baseline|Total|Total of all reporting groups
108428|NCT01743729|B2|Baseline|Placebo|
108429|NCT01743729|B1|Baseline|Lifitegrast|
108430|NCT01743729|P2|Participant Flow|Placebo|
108431|NCT01743729|P1|Participant Flow|Lifitegrast|
108432|NCT01743729|O2|Outcome|Placebo|
108433|NCT01743729|O1|Outcome|Lifitegrast|
108434|NCT01743729|O2|Outcome|Placebo|
108435|NCT01743729|O1|Outcome|Lifitegrast|
108436|NCT01743729|E2|Reported Event|Placebo|
108437|NCT01743729|E1|Reported Event|Lifitegrast|
108438|NCT01743521|B5|Baseline|Total|Total of all reporting groups
108440|NCT01743521|B3|Baseline|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108441|NCT01743521|B2|Baseline|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108442|NCT01743521|B1|Baseline|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108443|NCT01743521|P4|Participant Flow|No Group Allocated|Early treatment discontinuation or non-responder (participants in whom therapy was terminated at week 4 due to HCV RNA >1000 IU/mL or week 8 due to detectable HCV RNA)
108444|NCT01743521|P3|Participant Flow|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108521|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108522|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108445|NCT01743521|P2|Participant Flow|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108446|NCT01743521|P1|Participant Flow|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108447|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108448|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108449|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108450|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108451|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108452|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108453|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108454|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108455|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108523|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108524|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108456|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108457|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108458|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108459|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108460|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108461|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108462|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108502|NCT01743092|O2|Outcome|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.
Webinar: Some clients will receive a webinar as part of their treatment.
Tutuorial workbook: A work book about their addiciton"
108463|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108464|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108465|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108466|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108467|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108468|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108469|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108470|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108471|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108472|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108473|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108503|NCT01743092|O1|Outcome|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group
Tutuorial workbook: A work book about their addiciton"
108505|NCT01743092|E1|Reported Event|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group
Tutuorial workbook: A work book about their addiciton"
108506|NCT01743027|B5|Baseline|Total|Total of all reporting groups
108474|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108475|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108476|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108525|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108526|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108527|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108528|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108477|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108478|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108479|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108480|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108481|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108482|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108483|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108484|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108504|NCT01743092|E2|Reported Event|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.
Webinar: Some clients will receive a webinar as part of their treatment.
Tutuorial workbook: A work book about their addiciton"
108485|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108486|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108487|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108488|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108489|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108490|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108491|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108492|NCT01743521|E3|Reported Event|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108493|NCT01743521|E2|Reported Event|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108494|NCT01743521|E1|Reported Event|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
108495|NCT01743092|B3|Baseline|Total|Total of all reporting groups
108496|NCT01743092|B2|Baseline|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.
Webinar: Some clients will receive a webinar as part of their treatment.
Tutuorial workbook: A work book about their addiciton"
108497|NCT01743092|B1|Baseline|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group
Tutuorial workbook: A work book about their addiciton"
108498|NCT01743092|P2|Participant Flow|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.
Webinar: Some clients will receive a webinar as part of their treatment.
Tutuorial workbook: A work book about their addiciton"
108507|NCT01743027|B4|Baseline|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108508|NCT01743027|B3|Baseline|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108509|NCT01743027|B2|Baseline|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108510|NCT01743027|B1|Baseline|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108511|NCT01743027|P4|Participant Flow|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108512|NCT01743027|P3|Participant Flow|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108513|NCT01743027|P2|Participant Flow|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108514|NCT01743027|P1|Participant Flow|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108515|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108516|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108517|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108518|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108519|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108532|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108533|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108534|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108535|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108536|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108537|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108538|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108539|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108540|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108541|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108542|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108543|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108544|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108545|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108546|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108547|NCT01743027|E4|Reported Event|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108548|NCT01743027|E3|Reported Event|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108549|NCT01743027|E2|Reported Event|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108550|NCT01743027|E1|Reported Event|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
108551|NCT01742936|B3|Baseline|Total|Total of all reporting groups
108552|NCT01742936|B2|Baseline|Cardiac Bypass|"Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
CoaguChek: Hand held coagulation monitor.
Hospital Laboratory: Coagulation testing done by hospital laboratory."
108553|NCT01742936|B1|Baseline|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
CoaguChek: Hand held coagulation monitor.
Hospital Laboratory: Coagulation testing done by hospital laboratory."
108693|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo"
108554|NCT01742936|P2|Participant Flow|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
108555|NCT01742936|P1|Participant Flow|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
CoaguChek
Hospital Laboratory"
108556|NCT01742936|O2|Outcome|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
108557|NCT01742936|O1|Outcome|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
CoaguChek
Hospital Laboratory"
108558|NCT01742936|O2|Outcome|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
108559|NCT01742936|O1|Outcome|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
CoaguChek
Hospital Laboratory"
108560|NCT01742936|E2|Reported Event|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
108561|NCT01742936|E1|Reported Event|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
CoaguChek
Hospital Laboratory"
108562|NCT01742897|B1|Baseline|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
108563|NCT01742897|P1|Participant Flow|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
108564|NCT01742897|O1|Outcome|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
108565|NCT01742897|E1|Reported Event|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
108566|NCT01742832|B3|Baseline|Total|Total of all reporting groups
108567|NCT01742832|B2|Baseline|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
108568|NCT01742832|B1|Baseline|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
108569|NCT01742832|P2|Participant Flow|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
108570|NCT01742832|P1|Participant Flow|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
108571|NCT01742832|O2|Outcome|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
108572|NCT01742832|O1|Outcome|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
108573|NCT01742832|E2|Reported Event|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
108574|NCT01742832|E1|Reported Event|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
108575|NCT01742364|B5|Baseline|Total|Total of all reporting groups
108576|NCT01742364|B4|Baseline|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108577|NCT01742364|B3|Baseline|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108578|NCT01742364|B2|Baseline|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108579|NCT01742364|B1|Baseline|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108580|NCT01742364|P4|Participant Flow|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108581|NCT01742364|P3|Participant Flow|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108582|NCT01742364|P2|Participant Flow|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108583|NCT01742364|P1|Participant Flow|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108584|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108585|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108586|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108587|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108588|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108589|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108590|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108591|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108592|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108593|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108594|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108595|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108596|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108597|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108598|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108599|NCT01742364|O1|Outcome|Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108600|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108601|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108602|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108603|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108604|NCT01742364|E4|Reported Event|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108605|NCT01742364|E3|Reported Event|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108606|NCT01742364|E2|Reported Event|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.
Needle and syringe"
108607|NCT01742364|E1|Reported Event|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.
Bioject ID Pen"
108608|NCT01741792|B4|Baseline|Total|Total of all reporting groups
108609|NCT01741792|B3|Baseline|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108610|NCT01741792|B2|Baseline|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108611|NCT01741792|B1|Baseline|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108612|NCT01741792|P3|Participant Flow|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108613|NCT01741792|P2|Participant Flow|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108614|NCT01741792|P1|Participant Flow|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108615|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108616|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108617|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108618|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108619|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108620|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108621|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108622|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108623|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108624|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108625|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108626|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108627|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108628|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108629|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108630|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108631|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108632|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108633|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108634|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108635|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108636|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108637|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108638|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108639|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108640|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108641|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108642|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108643|NCT01741792|O3|Outcome|Blinatumomab 112 μg/d|Participants received blinatumomab administered CIV 112 µg/day.
108644|NCT01741792|O2|Outcome|Blinatumomab 28 μg/d|Participants received blinatumomab CIV 28 µg/day.
108645|NCT01741792|O1|Outcome|Blinatumomab 9 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day.
108646|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108647|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108648|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108649|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108650|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108694|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)"
108695|NCT01741701|E2|Reported Event|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo"
108651|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108652|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108653|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108654|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108655|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108656|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108657|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108658|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108659|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108660|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108661|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108662|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108663|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108664|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108665|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108696|NCT01741701|E1|Reported Event|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)"
108910|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day
Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
108666|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108667|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108668|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108669|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108670|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108671|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108672|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108673|NCT01741792|E5|Reported Event|Blinatumomab Overall|All participants who received blinatumomab by continuous intravenous infusion during the core study.
108925|NCT01740427|B1|Baseline|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108674|NCT01741792|E4|Reported Event|Cohort 1+3: Blinatumomab 9/28/112µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108675|NCT01741792|E3|Reported Event|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108676|NCT01741792|E2|Reported Event|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108677|NCT01741792|E1|Reported Event|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
108678|NCT01741701|B3|Baseline|Total|Total of all reporting groups
108679|NCT01741701|B2|Baseline|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo"
108680|NCT01741701|B1|Baseline|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)"
108681|NCT01741701|P2|Participant Flow|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo"
108682|NCT01741701|P1|Participant Flow|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)"
108683|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo"
108684|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)"
108685|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo"
108686|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)"
108687|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo"
108688|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)"
108689|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo"
108690|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)"
108691|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo"
108692|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)"
108697|NCT01741688|B1|Baseline|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108698|NCT01741688|P1|Participant Flow|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108699|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108700|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108701|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108702|NCT01741688|O1|Outcome|Cohort|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108703|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108704|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108926|NCT01740427|P2|Participant Flow|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108705|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108706|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108707|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108708|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108709|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108710|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108711|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108712|NCT01741688|O1|Outcome|Cohort|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108713|NCT01741688|E1|Reported Event|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab: Tocilizumab was administered according to the local label."
108714|NCT01741350|B3|Baseline|Total|Total of all reporting groups
108857|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
108911|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day
Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
108715|NCT01741350|B2|Baseline|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108716|NCT01741350|B1|Baseline|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108717|NCT01741350|P2|Participant Flow|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108927|NCT01740427|P1|Participant Flow|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108928|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108929|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108968|NCT01740414|O2|Outcome|MN-166 + Oxy 15 mg|The Effects of 15 mg of oxycodone while under MN-166 maintenance.
108718|NCT01741350|P1|Participant Flow|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108719|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108720|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108721|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108722|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108723|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108724|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108725|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108930|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108931|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108932|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
109066|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
108726|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108727|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108728|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108729|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108730|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108731|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108858|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
108859|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
108860|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
108732|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108733|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108734|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108735|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108736|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108737|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108738|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108739|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108861|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
108862|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
108863|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
108740|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108741|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108742|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108743|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108744|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108745|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108746|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108747|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108864|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
108865|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
108866|NCT01741272|E2|Reported Event|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
108748|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108749|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108750|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108751|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108752|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108753|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108754|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108755|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108867|NCT01741272|E1|Reported Event|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
108868|NCT01740817|B1|Baseline|All Study Participants|Participants who were randomized to receive either lipid or saline
108869|NCT01740817|P2|Participant Flow|Saline Then Lipid|Saline infusion 30 ml/h for 48 h, then lipid 30 ml/h for 48 h
108870|NCT01740817|P1|Participant Flow|Lipid Then Saline|Intralipid 20% 30 ml/h for 48 h, then saline 30 ml/h for 48 h
108871|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
108756|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108757|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108758|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108759|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108760|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108761|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108762|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108763|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108872|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
108873|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
108874|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
108875|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
108876|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
108877|NCT01740817|E2|Reported Event|Intralipid|Saline infusion 20%, at 30 ml/h for 48 h, then washout 4-6 weeks, then Intralipid 30 ml/h for 48 h
108878|NCT01740817|E1|Reported Event|Saline|Intralipid infusion 20%, at 30 ml/h for 48 h, then washout 4-6 weeks, then saline 30 ml/h for 48 h
108764|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108765|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108766|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108767|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108768|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108769|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108770|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108771|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108879|NCT01740726|B3|Baseline|Total|Total of all reporting groups
108880|NCT01740726|B2|Baseline|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
108912|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day
Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
108772|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108773|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
109067|NCT01739803|O2|Outcome|Control Group|No intervention
108774|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108775|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108776|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108777|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108778|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108779|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108881|NCT01740726|B1|Baseline|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
108882|NCT01740726|P2|Participant Flow|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
108780|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108781|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108782|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108783|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108784|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108785|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108786|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108787|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108883|NCT01740726|P1|Participant Flow|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
108884|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
108788|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108789|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108790|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108791|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108792|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108793|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108794|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108795|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108885|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
108886|NCT01740726|E2|Reported Event|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
108796|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108797|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108798|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108799|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108800|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108801|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108802|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108803|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108887|NCT01740726|E1|Reported Event|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
108888|NCT01740713|B4|Baseline|Total|Total of all reporting groups
108889|NCT01740713|B3|Baseline|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day
Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
108913|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
108804|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108805|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108806|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108807|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108808|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108809|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108810|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108811|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108890|NCT01740713|B2|Baseline|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day
Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
108891|NCT01740713|B1|Baseline|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day
Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
108892|NCT01740713|P3|Participant Flow|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day
Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
108893|NCT01740713|P2|Participant Flow|Deferiprone 50 mg/kg/da|"Deferiprone will be administered at 50 mg/kg/day
Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
108812|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108813|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108814|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108815|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108816|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108817|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108818|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108819|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108894|NCT01740713|P1|Participant Flow|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day
Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
108895|NCT01740713|O1|Outcome|Safety Population|patients who may experience adverse events occurred before or after treatment
108896|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day
Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
108897|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day
Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
108820|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108821|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108822|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108823|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108824|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108825|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108826|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108827|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108898|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day
Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
108899|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day
Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
108900|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day
Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
108901|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day
Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
108828|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108829|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108830|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108831|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108832|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108833|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108834|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108835|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108902|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day
Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
108903|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day
Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
108904|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day
Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
108905|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
108836|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108837|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108838|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108839|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108840|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108841|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108842|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108843|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108906|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day
Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
108907|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day
Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
108908|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day
Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
108909|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
108844|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108845|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108846|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108847|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108848|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108849|NCT01741350|E2|Reported Event|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control Condition: Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
108850|NCT01741350|E1|Reported Event|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
Community-friendly Health Recovery Program: Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
108851|NCT01741272|B3|Baseline|Total|Total of all reporting groups
108852|NCT01741272|B2|Baseline|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
108853|NCT01741272|B1|Baseline|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
108854|NCT01741272|P2|Participant Flow|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
108855|NCT01741272|P1|Participant Flow|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
108856|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
109091|NCT01739361|E2|Reported Event|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.
placebo"
108914|NCT01740713|E3|Reported Event|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day
Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
108915|NCT01740713|E2|Reported Event|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day
Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
108916|NCT01740713|E1|Reported Event|Deferiprone 25mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day
Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
108917|NCT01740440|B1|Baseline|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks
BMR Face"
108918|NCT01740440|P1|Participant Flow|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks
BMR Face"
108919|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks
BMR Face"
108920|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks
BMR Face: BMR Face used in accordance with manufacturer IFU"
108921|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks
BMR Face"
108922|NCT01740440|E1|Reported Event|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks
BMR Face"
108923|NCT01740427|B3|Baseline|Total|Total of all reporting groups
108924|NCT01740427|B2|Baseline|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108933|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108934|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108935|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108936|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108937|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108938|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108939|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108940|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108941|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108942|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108943|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108944|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108945|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108946|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108947|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108948|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108949|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108950|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108951|NCT01740427|E2|Reported Event|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108952|NCT01740427|E1|Reported Event|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
108953|NCT01740414|B3|Baseline|Total|Total of all reporting groups
108954|NCT01740414|B2|Baseline|Placebo|Patient began maintenance on placebo medication prior to maintenance active medication (MN-166, formerly AV411). The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo, then MN-166). Data are only from participants who completed both phases of the study.
108955|NCT01740414|B1|Baseline|MN-166 (Formerly AV411)|Patient began maintenance on active medication first (MN-166, formerly AV411) prior to maintenance on placebo. The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (MN-166, then placebo). Data are only from participants who completed both phases of the study.
108956|NCT01740414|P2|Participant Flow|Placebo First|Patient began maintenance on placebo medication prior to switching to the active medication condition(MN-166). The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo then MN-166).
108957|NCT01740414|P1|Participant Flow|MN-166 First|Patient began maintenance on active medication first (MN-166, formerly AV411) prior to maintenance on placebo.The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (MN-166, then Placebo).
108958|NCT01740414|O6|Outcome|Placebo + Oxy 30 mg|The Effects of 30 mg of oxycodone while under placebo maintenance.
108959|NCT01740414|O5|Outcome|Placebo + Oxy 15 mg|The Effects of 15 mg of oxycodone while under placebo maintenance.
108960|NCT01740414|O4|Outcome|Placebo Oxy 0 mg|The Effects of 0 mg of oxycodone while under placebo maintenance.
108961|NCT01740414|O3|Outcome|MN-166 + Oxy 30 mg|The Effects of 30 mg of oxycodone while under MN-166 maintenance.
108962|NCT01740414|O2|Outcome|MN-166 + Oxy 15 mg|The Effects of 15 mg of oxycodone while under MN-166 maintenance.
108963|NCT01740414|O1|Outcome|MN-166 + Oxy 0 mg|The Effects of 0 mg of oxycodone while under MN-166 maintenance.
108964|NCT01740414|O6|Outcome|Placebo + Oxy 30 mg|The Effects of 30 mg of oxycodone while under placebo maintenance.
108965|NCT01740414|O5|Outcome|Placebo + Oxy 15 mg|The Effects of 15 mg of oxycodone while under placebo maintenance.
108966|NCT01740414|O4|Outcome|Placebo + Oxy 0 mg|The Effects of 0 mg of oxycodone while under placebo maintenance.
108967|NCT01740414|O3|Outcome|MN-166 + Oxy 30 mg|The Effects of 30 mg of oxycodone while under MN-166 maintenance.
108969|NCT01740414|O1|Outcome|MN-166 + Oxy 0 mg|The Effects of 0 mg of oxycodone while under MN-166 maintenance.
108970|NCT01740414|O6|Outcome|Placebo + Oxy 30 mg|The Effects of 30 mg of oxycodone while under placebo maintenance.
108971|NCT01740414|O5|Outcome|Placebo + Oxy 15 mg|The Effects of 15 mg of oxycodone while under placebo maintenance.
108972|NCT01740414|O4|Outcome|Placebo + Oxy 0 mg|The Effects of 0 mg of oxycodone while under placebo maintenance.
108973|NCT01740414|O3|Outcome|MN-166 + Oxy 30 mg|The Effects of 30 mg of oxycodone while under MN-166 maintenance.
108974|NCT01740414|O2|Outcome|MN-166 + Oxy 15 mg|The Effects of 15 mg of oxycodone while under MN-166 maintenance.
108975|NCT01740414|O1|Outcome|MN-166 + Oxy 0 mg|The Effects of 0 mg of oxycodone while under MN-166 maintenance.
108976|NCT01740414|E2|Reported Event|Placebo|"Patient is receiving placebo first.
placebo: In the placebo arm, the patients receive placebo for 20 days"
108977|NCT01740414|E1|Reported Event|MN-166 (Formerly AV411)|"Patient is receiving study drug (MN-166) first
MN-166 (formerly AV411): in one study arm, 50mg MN-166 BID are administered daily for 20 days"
108978|NCT01740401|B1|Baseline|Cyclophosphamide, Ipilimumab|"Treatment:
Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)
Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv
Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
108979|NCT01740401|P1|Participant Flow|Cyclophosphamide, Ipilimumab|"Treatment:
Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)
Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv
Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
108980|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:
Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)
Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv
Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
108999|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
108981|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:
Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)
Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv
Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
108982|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:
Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)
Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv
Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
108983|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:
Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)
Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv
Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
108984|NCT01740401|E1|Reported Event|Cyclophosphamide, Ipilimumab|"Treatment:
Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)
Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv
Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimuab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
108985|NCT01740388|B3|Baseline|Total|Total of all reporting groups
108986|NCT01740388|B2|Baseline|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
108987|NCT01740388|B1|Baseline|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
108988|NCT01740388|P2|Participant Flow|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
108989|NCT01740388|P1|Participant Flow|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
108990|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
108991|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
108992|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
108993|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
108994|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
108995|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
108996|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
108997|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
108998|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
109028|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
109000|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
109001|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
109002|NCT01740388|E2|Reported Event|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
109003|NCT01740388|E1|Reported Event|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
109004|NCT01740362|B5|Baseline|Total|Total of all reporting groups
109005|NCT01740362|B4|Baseline|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109006|NCT01740362|B3|Baseline|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109007|NCT01740362|B2|Baseline|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109008|NCT01740362|B1|Baseline|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
109009|NCT01740362|P4|Participant Flow|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109010|NCT01740362|P3|Participant Flow|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109011|NCT01740362|P2|Participant Flow|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109012|NCT01740362|P1|Participant Flow|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
109068|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
109069|NCT01739803|E2|Reported Event|Control Group|No intervention
109013|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109014|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109015|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109016|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
109017|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109018|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109019|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109020|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
109021|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109022|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109023|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109024|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
109025|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109026|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109027|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109090|NCT01739361|O1|Outcome|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.
Acetaminophen"
109029|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109030|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109031|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109032|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
109033|NCT01740362|E4|Reported Event|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109034|NCT01740362|E3|Reported Event|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109035|NCT01740362|E2|Reported Event|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
109036|NCT01740362|E1|Reported Event|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
109037|NCT01740089|B4|Baseline|Total|Total of all reporting groups
109038|NCT01740089|B3|Baseline|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
109039|NCT01740089|B2|Baseline|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
109040|NCT01740089|B1|Baseline|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
109041|NCT01740089|P3|Participant Flow|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
109042|NCT01740089|P2|Participant Flow|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
109043|NCT01740089|P1|Participant Flow|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
109044|NCT01740089|O2|Outcome|PegIntron (n=50)|
109045|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
109046|NCT01740089|O2|Outcome|PegIntron (n=50)|
109047|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
109048|NCT01740089|O2|Outcome|PegIntron (n=50)|
109049|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
109050|NCT01740089|O3|Outcome|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
109051|NCT01740089|O2|Outcome|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
109052|NCT01740089|O1|Outcome|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
109053|NCT01740089|O3|Outcome|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
109054|NCT01740089|O2|Outcome|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
109055|NCT01740089|O1|Outcome|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
109056|NCT01740089|E2|Reported Event|PegIntron (n=50)|
109057|NCT01740089|E1|Reported Event|Algeron (n=101)|The safety analysis included 101 patients received at least 1 dose of Algeron (taking into account one patient withdrawn at early stages of the study due to a protocol violation [severe depression by the Beck's scale before the first injection], who was withdrawn from the mITT-analysis)
109058|NCT01739803|B3|Baseline|Total|Total of all reporting groups
109059|NCT01739803|B2|Baseline|Control Group|No intervention
109060|NCT01739803|B1|Baseline|Intervention Group|Behavioral contract intervention
109061|NCT01739803|P2|Participant Flow|Control Group|"No intervention.
The control group received standard specialty pharmacy care, which included mail or telephone reminders of monthly medication refills and an adherence packet consisting of adherence-focused educational pamphlets and a pillbox"
109062|NCT01739803|P1|Participant Flow|Intervention Group|"Behavioral contract intervention.
Each participant in the intervention group met with the study pharmacist to negotiate and sign an immunosuppressant therapy (IST) adherence contract at baseline. Each intervention participant met with the study pharmacist at 3-, 6-, and 9-months post-enrollment to review his or her contract, discuss progress toward reaching the contract's goal of achieving the highest possible IST adherence, update terms of the contract if needed, and re-sign the contract for the next three-month period. At the 12-month post-enrollment meeting, the contract was terminated.
The contract included: (a) motivation(s) for achieving adherence; (b) barriers that may interfere with achieving adherence and possible solutions to overcome barriers; (c) social support available such as a significant other who may assist in following the dosing schedule; (d) tools/strategies to follow the dosing schedule; and (e) possible consequences of nonadherence"
109063|NCT01739803|O2|Outcome|Control Group|No intervention
109064|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
109065|NCT01739803|O2|Outcome|Control Group|No intervention
109072|NCT01739595|B3|Baseline|Placebo|"Placebo oral capsules taken one time daily
Placebo: Oral capsule taken one time daily for 3 months"
109073|NCT01739595|B2|Baseline|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
109074|NCT01739595|B1|Baseline|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
109075|NCT01739595|P3|Participant Flow|Placebo|"Placebo oral capsules taken one time daily
Placebo: Oral capsule taken one time daily for 3 months"
109076|NCT01739595|P2|Participant Flow|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
109077|NCT01739595|P1|Participant Flow|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
109078|NCT01739595|O2|Outcome|Placebo|"Placebo oral capsules taken one time daily
Placebo: Oral capsule taken one time daily for 3 months"
109079|NCT01739595|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
109080|NCT01739595|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
109081|NCT01739595|E3|Reported Event|Placebo|"Placebo oral capsules taken one time daily
Placebo: Oral capsule taken one time daily for 3 months"
109082|NCT01739595|E2|Reported Event|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
109083|NCT01739595|E1|Reported Event|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
109084|NCT01739361|B3|Baseline|Total|Total of all reporting groups
109085|NCT01739361|B2|Baseline|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.
placebo"
109086|NCT01739361|B1|Baseline|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.
Acetaminophen"
109087|NCT01739361|P2|Participant Flow|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.
placebo"
109088|NCT01739361|P1|Participant Flow|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.
Acetaminophen"
109089|NCT01739361|O2|Outcome|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.
placebo"
109092|NCT01739361|E1|Reported Event|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.
Acetaminophen"
109093|NCT01738984|B3|Baseline|Total|Total of all reporting groups
109094|NCT01738984|B2|Baseline|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
109095|NCT01738984|B1|Baseline|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet"
109096|NCT01738984|P2|Participant Flow|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
109097|NCT01738984|P1|Participant Flow|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet"
109098|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
109099|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet"
109100|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
109101|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet"
109102|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
109103|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet"
109104|NCT01738984|E2|Reported Event|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
109105|NCT01738984|E1|Reported Event|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet"
109106|NCT01738971|B4|Baseline|Total|Total of all reporting groups
109107|NCT01738971|B3|Baseline|Progestogen Only Pill|"one month progestogen only pill
one month progestogen only pill"
109108|NCT01738971|B2|Baseline|Rapid Access|"rapid access to family planning service
rapid access to contraceptive service"
109109|NCT01738971|B1|Baseline|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
109110|NCT01738971|P3|Participant Flow|Progestogen Only Pill|"one month progestogen only pill
one month progestogen only pill"
109111|NCT01738971|P2|Participant Flow|Rapid Access|"rapid access to family planning service
rapid access to contraceptive service"
109112|NCT01738971|P1|Participant Flow|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
109113|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill
one month progestogen only pill"
109114|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service
rapid access to contraceptive service"
109115|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
109116|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill
one month progestogen only pill"
109117|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service
rapid access to contraceptive service"
109118|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
109119|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill
one month progestogen only pill"
109121|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
109122|NCT01738971|E3|Reported Event|Progestogen Only Pill|"one month progestogen only pill
one month progestogen only pill"
109123|NCT01738971|E2|Reported Event|Rapid Access|"rapid access to family planning service
rapid access to contraceptive service"
109124|NCT01738971|E1|Reported Event|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
109125|NCT01738919|B3|Baseline|Total|Total of all reporting groups
109126|NCT01738919|B2|Baseline|Non-subluxated - Operation|"Operative treatment with extension block technique
Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks."
109127|NCT01738919|B1|Baseline|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.
Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
109128|NCT01738919|P2|Participant Flow|Non-subluxated - Operation|"Operative treatment with extension block technique
Operative treatment with extension block technique"
109129|NCT01738919|P1|Participant Flow|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.
Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
109130|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
109131|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
109132|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
109133|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
109134|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
109135|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
109136|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
109137|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
109138|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
109139|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
109140|NCT01738919|O2|Outcome|Non-subluxated - Operation|"Operative treatment with extension block technique
Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks."
109141|NCT01738919|O1|Outcome|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.
Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
109142|NCT01738919|E2|Reported Event|Non-subluxated - Operation|"Operative treatment with extension block technique
Operative treatment with extension block technique"
109143|NCT01738919|E1|Reported Event|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.
Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
109144|NCT01738750|B3|Baseline|Total|Total of all reporting groups
109145|NCT01738750|B2|Baseline|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
109146|NCT01738750|B1|Baseline|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.
Cost Information Included"
109147|NCT01738750|P2|Participant Flow|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
109148|NCT01738750|P1|Participant Flow|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.
Cost Information Included"
109149|NCT01738750|O2|Outcome|No Dollar Information Included|Group of patients that will not receive dollar information for the laparoscopic and open surgical procedures prior to choice of procedure.
109150|NCT01738750|O1|Outcome|Dollar Information Included|"Group of patients that will receive dollars information for both the laparoscopic and open surgical procedures prior to choice of procedure.
Dollars Information Included"
109151|NCT01738750|O2|Outcome|No Cost Information Included|Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
109152|NCT01738750|O1|Outcome|Cost Information Included|Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
109153|NCT01738750|E2|Reported Event|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
109154|NCT01738750|E1|Reported Event|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.
Cost Information Included"
109155|NCT01738737|B6|Baseline|Total|Total of all reporting groups
109156|NCT01738737|B5|Baseline|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
109157|NCT01738737|B4|Baseline|Active Laser|"Application of active laser only during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
109158|NCT01738737|B3|Baseline|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109159|NCT01738737|B2|Baseline|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
109160|NCT01738737|B1|Baseline|Stretching|"Seven stretching exercises for lower limbs during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109161|NCT01738737|P5|Participant Flow|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
109162|NCT01738737|P4|Participant Flow|Active Laser|"Application of active laser only during 24 sessions
Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial)"
109163|NCT01738737|P3|Participant Flow|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions
Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial)
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109164|NCT01738737|P2|Participant Flow|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
placebo laser therapy: 9 points of application of placebo laser per knee (frontal faces, lateral and medial)"
109165|NCT01738737|P1|Participant Flow|Stretching|"Seven stretching exercises for lower limbs during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109166|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
109167|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
109168|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109169|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
109170|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109171|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
109172|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
109173|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109174|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
109175|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109212|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109176|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
109177|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
109178|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109179|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
109180|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109181|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
109182|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
109183|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109184|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
109185|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109186|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
109187|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
109188|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109238|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109189|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
109190|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109191|NCT01738737|E5|Reported Event|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
109192|NCT01738737|E4|Reported Event|Active Laser|"Application of active laser only during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
109193|NCT01738737|E3|Reported Event|Stretching|"Seven stretching exercises for lower limbs during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109194|NCT01738737|E2|Reported Event|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
109195|NCT01738737|E1|Reported Event|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions
Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)
Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
109196|NCT01738698|B5|Baseline|Total|Total of all reporting groups
109197|NCT01738698|B4|Baseline|Placebo|Placebo: Oral administration once-daily for 12 weeks
109198|NCT01738698|B3|Baseline|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109199|NCT01738698|B2|Baseline|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109200|NCT01738698|B1|Baseline|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109201|NCT01738698|P4|Participant Flow|Placebo|Placebo: Oral administration once-daily for 12 weeks
109202|NCT01738698|P3|Participant Flow|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109203|NCT01738698|P2|Participant Flow|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109204|NCT01738698|P1|Participant Flow|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109205|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109206|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109207|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109208|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109209|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109210|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109211|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109214|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109215|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109216|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109217|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109218|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109219|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109220|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109221|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109222|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109223|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109224|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109225|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109226|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109227|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109228|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109229|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109230|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109231|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109232|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109233|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109234|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109235|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109236|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109237|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109239|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109240|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109241|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109242|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109243|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109244|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109245|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109246|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109247|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109248|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109249|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109250|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109251|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109252|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109253|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109254|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109255|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109256|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109257|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109258|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109259|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109260|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109261|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
109262|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109263|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109264|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109265|NCT01738698|E4|Reported Event|Placebo|Placebo: Oral administration once-daily for 12 weeks
109266|NCT01738698|E3|Reported Event|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
109267|NCT01738698|E2|Reported Event|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
109268|NCT01738698|E1|Reported Event|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
109269|NCT01738646|B1|Baseline|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
109270|NCT01738646|P1|Participant Flow|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
109803|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109271|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
109272|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
109273|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
109274|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|"Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
Vorinostat
Bevacizumab"
109275|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
109276|NCT01738646|E1|Reported Event|Vorinostat & Bevacizumab|Patients will be evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
109277|NCT01738581|B3|Baseline|Total|Total of all reporting groups
109278|NCT01738581|B2|Baseline|rTMS + CTL, rTMS + Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation (rTMS) with control therapy (CTL). CTL therapy was non-specific therapy that includes stretching, massage, range of motion for the first phase, then rTMS with sensorimotor retraining.
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
109279|NCT01738581|B1|Baseline|rTMS + Sensorimotor Retraining, rTMS + CTL|"Repetitive transcranial magnetic (rTMS) stimulation and sensorimotor retraining for the first phase, then rTMS with control therapy (CTL). CTL therapy was non-specific therapy that includes stretching, massage, range of motion.
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.
Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
109280|NCT01738581|P2|Participant Flow|rTMS + CTL, Then rTMS + SMR|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
109301|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
109373|NCT01737944|E4|Reported Event|25mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
109281|NCT01738581|P1|Participant Flow|rTMS + SMR, Then rTMS + CTL|"Repetitive transcranial magnetic stimulation and sensorimotor retraining
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.
Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
109282|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
109283|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.
Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
109284|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
109285|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.
Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
109286|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
109287|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.
Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
109288|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
109289|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.
Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
109290|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
109291|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.
Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
109804|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109292|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
109293|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.
Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
109294|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
109295|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.
Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
109296|NCT01738581|E2|Reported Event|rTMS With CTL, Then rTMS With Sensorimotor Retrain|"Repetitive transcranial magnetic stimulation (rTMS) with control (CTL) non-specific therapy that includes stretching, massage, range of motion for first phase, then rTMS with sensorimotor retraining for second phase.
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.
Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
109297|NCT01738581|E1|Reported Event|rTMS With Sensorimotor Retraining, Then rTMS With CTL|"Repetitive transcranial magnetic stimulation (rTMS) and sensorimotor retraining for first phase, then rTMS with control (CTL) therapy.
Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.
Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
109298|NCT01738438|B1|Baseline|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
109299|NCT01738438|P1|Participant Flow|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
109300|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
109367|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
109302|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
109303|NCT01738438|E1|Reported Event|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
109304|NCT01738321|B3|Baseline|Total|Total of all reporting groups
109305|NCT01738321|B2|Baseline|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
109306|NCT01738321|B1|Baseline|Cardiac Patients|"Patients undergoing cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
109307|NCT01738321|P2|Participant Flow|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
109308|NCT01738321|P1|Participant Flow|Cardiac Patients|"Patients undergoing cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
109309|NCT01738321|O2|Outcome|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
109310|NCT01738321|O1|Outcome|Cardiac Patients|"Patients undergoing cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
109311|NCT01738321|E2|Reported Event|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
109312|NCT01738321|E1|Reported Event|Cardiac Patients|"Patients undergoing cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
109313|NCT01737996|B4|Baseline|Total|Total of all reporting groups
109314|NCT01737996|B3|Baseline|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109315|NCT01737996|B2|Baseline|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
109316|NCT01737996|B1|Baseline|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
109317|NCT01737996|P3|Participant Flow|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109318|NCT01737996|P2|Participant Flow|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
109319|NCT01737996|P1|Participant Flow|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
109320|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109321|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109322|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109323|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109324|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109325|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109326|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109327|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109328|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109329|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109330|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
109331|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
109332|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
109368|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
109333|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
109334|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
109335|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
109336|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
109337|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
109338|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
109339|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
109340|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
109341|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
109342|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
109343|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
109344|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109345|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109346|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109347|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109348|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
109349|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
109350|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
109351|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
109352|NCT01737996|E3|Reported Event|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
109353|NCT01737996|E2|Reported Event|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
109354|NCT01737996|E1|Reported Event|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
109355|NCT01737944|B5|Baseline|Total|Total of all reporting groups
109356|NCT01737944|B4|Baseline|25mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
109357|NCT01737944|B3|Baseline|20mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
109358|NCT01737944|B2|Baseline|15mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
109359|NCT01737944|B1|Baseline|10mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
109360|NCT01737944|P4|Participant Flow|25mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
109361|NCT01737944|P3|Participant Flow|20mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
109362|NCT01737944|P2|Participant Flow|15mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
109363|NCT01737944|P1|Participant Flow|10mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
109364|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
109365|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
109366|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
109374|NCT01737944|E3|Reported Event|20mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
109375|NCT01737944|E2|Reported Event|15mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
109376|NCT01737944|E1|Reported Event|10mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
109377|NCT01737931|B4|Baseline|Total|Total of all reporting groups
109378|NCT01737931|B3|Baseline|No-treatment|No treatment to the application sites after the patch removal
109379|NCT01737931|B2|Baseline|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
109380|NCT01737931|B1|Baseline|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
109381|NCT01737931|P3|Participant Flow|No-treatment|No treatment to the application sites after the patch removal
109382|NCT01737931|P2|Participant Flow|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
109383|NCT01737931|P1|Participant Flow|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
109384|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
109385|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
109386|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
109387|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
109388|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
109389|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
109390|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
109391|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
109392|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
109393|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
109394|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
109395|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
109396|NCT01737931|E1|Reported Event|Over-all|"In this study, all the subjects were received SPM962 with the same dose and regimen during the acceleration and dose-escalation periods and then they were randomized into one of the three groups after removal of SPM962 to evaluate recovery of skin reaction caused by SPM962 using either steroids, antihistamine or no treatment.
Since AEs mainly occurred in the acceleration and dose-escalation periods when SPM962 were used, AEs are shown in one group."
109397|NCT01737879|B1|Baseline|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
109950|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109398|NCT01737879|P1|Participant Flow|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
109399|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
109400|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
109401|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
109402|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
109403|NCT01737879|E1|Reported Event|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
109404|NCT01737840|B3|Baseline|Total|Total of all reporting groups
109405|NCT01737840|B2|Baseline|Ranitidine|"Intravenous ranitidine 50 mg
Ranitidine: 33 patients"
109406|NCT01737840|B1|Baseline|Pantoprazole|"Intravenous pantoprazole 40 mg flacon
Pantoprazole: 33 patients"
109407|NCT01737840|P2|Participant Flow|Ranitidine|"Intravenous ranitidine 50 mg
Ranitidine: 33 patients"
109408|NCT01737840|P1|Participant Flow|Pantoprazole|"Intravenous pantoprazole 40 mg flacon
Pantoprazole: 33 patients"
109409|NCT01737840|O2|Outcome|Ranitidine|"Intravenous ranitidine 50 mg
Ranitidine: 33 patients"
109410|NCT01737840|O1|Outcome|Pantoprazole|"Intravenous pantoprazole 40 mg flacon
Pantoprazole: 33 patients"
109411|NCT01737840|O2|Outcome|Ranitidine|Intravenous ranitidine 50 mg
109412|NCT01737840|O1|Outcome|Pantoprazole|Intravenous pantoprazole 40 mg
109413|NCT01737840|E2|Reported Event|Ranitidine|"Intravenous ranitidine 50 mg
Ranitidine: 33 patients"
109414|NCT01737840|E1|Reported Event|Pantoprazole|"Intravenous pantoprazole 40 mg flacon
Pantoprazole: 33 patients"
109415|NCT01737762|B3|Baseline|Total|Total of all reporting groups
109416|NCT01737762|B2|Baseline|Vehicle|Vehicle Control(fibrinogen solution & thrombin solution without cells)
109417|NCT01737762|B1|Baseline|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
109418|NCT01737762|P2|Participant Flow|Vehicle|Vehicle Control(fibrinogen solution & thrombin solution without cells)
109419|NCT01737762|P1|Participant Flow|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
109420|NCT01737762|O2|Outcome|Vehicle|Vehicle Control(fibrinogen solution & thrombin solution without cells)
109421|NCT01737762|O1|Outcome|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
109422|NCT01737762|O2|Outcome|Vehicle|Vehicle Control(fibrinogen solution & thrombin solution without cells)
109423|NCT01737762|O1|Outcome|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
109424|NCT01737762|E2|Reported Event|Vehicle|"Vehicle Control(fibrinogen solution & thrombin solution without cells)
Vehicle"
109425|NCT01737762|E1|Reported Event|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
109426|NCT01737710|B6|Baseline|Total|Total of all reporting groups
109427|NCT01737710|B5|Baseline|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109428|NCT01737710|B4|Baseline|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
109429|NCT01737710|B3|Baseline|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
109430|NCT01737710|B2|Baseline|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109431|NCT01737710|B1|Baseline|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109432|NCT01737710|P5|Participant Flow|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109433|NCT01737710|P4|Participant Flow|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
109434|NCT01737710|P3|Participant Flow|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
109435|NCT01737710|P2|Participant Flow|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109436|NCT01737710|P1|Participant Flow|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109437|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
109438|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109439|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
109440|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109441|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
109442|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109443|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109444|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109445|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109446|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109447|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109448|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109449|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
109450|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109451|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
109452|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109453|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
109454|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109455|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109456|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109457|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109458|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109459|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109460|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109461|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109462|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109463|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109464|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109465|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109466|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109467|NCT01737710|E5|Reported Event|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109468|NCT01737710|E4|Reported Event|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
109469|NCT01737710|E3|Reported Event|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
109470|NCT01737710|E2|Reported Event|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109471|NCT01737710|E1|Reported Event|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
109472|NCT01737684|B3|Baseline|Total|Total of all reporting groups
109473|NCT01737684|B2|Baseline|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
109474|NCT01737684|B1|Baseline|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
109475|NCT01737684|P3|Participant Flow|Participants With Mild Hepatic Insufficiencey|Participants with mild hepatic insufficiency were to receive a single oral dose of vibegron 100 mg.
109476|NCT01737684|P2|Participant Flow|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
109477|NCT01737684|P1|Participant Flow|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
109478|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
109479|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
109480|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
109481|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
109482|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
109483|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
109484|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
109485|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
109486|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
109487|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
109488|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
109489|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
109490|NCT01737684|E2|Reported Event|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
109491|NCT01737684|E1|Reported Event|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
109492|NCT01737593|B4|Baseline|Total|Total of all reporting groups
109493|NCT01737593|B3|Baseline|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109494|NCT01737593|B2|Baseline|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109495|NCT01737593|B1|Baseline|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)
Acetaminophen"
109496|NCT01737593|P3|Participant Flow|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109497|NCT01737593|P2|Participant Flow|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109498|NCT01737593|P1|Participant Flow|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)
Acetaminophen"
109499|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109500|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109501|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)
Acetaminophen"
109502|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109503|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109504|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)
Acetaminophen"
109505|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109506|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109507|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)
Acetaminophen"
109508|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109509|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109510|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)
Acetaminophen"
109511|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109512|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109513|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)
Acetaminophen"
109514|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109515|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109516|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)
Acetaminophen"
109517|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109518|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109519|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)
Acetaminophen"
109520|NCT01737593|O3|Outcome|Acetaminophen by Mouth (PO) - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109625|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109521|NCT01737593|O2|Outcome|Acetaminophen by Mouth (PO) - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109522|NCT01737593|O1|Outcome|Acetaminophen by Rectum (PR)|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)
Acetaminophen"
109523|NCT01737593|E3|Reported Event|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109524|NCT01737593|E2|Reported Event|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)
Acetaminophen"
109525|NCT01737593|E1|Reported Event|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)
Acetaminophen"
109526|NCT01737021|B3|Baseline|Total|Total of all reporting groups
109527|NCT01737021|B2|Baseline|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
109528|NCT01737021|B1|Baseline|Psycho-educational Intervention|Received psycho-educational intervention.
109529|NCT01737021|P2|Participant Flow|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
109530|NCT01737021|P1|Participant Flow|Psycho-educational Intervention|"Psycho-education
Psycho-education: The information given to parents will cover expected reactions that follow a PICU admission; how parents can help their child cope with these reactions; how to recognise warning signs; and sign-posting of appropriate follow-up services (if relevant). There will also be a follow-up telephone call to reinforce the information and to support parents in putting it in to practice, if appropriate."
109531|NCT01737021|O2|Outcome|Study Design|There were also six feasibility criteria related to the study design, covering recruitment/ participation rate, acceptability of procedures, loss to follow-up rate, and the time-scale of data collection.
109532|NCT01737021|O1|Outcome|Intervention|There were six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation.
109533|NCT01737021|E2|Reported Event|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
109534|NCT01737021|E1|Reported Event|Psycho-educational Intervention|Received psycho-educational intervention.
109535|NCT01736930|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109560|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109561|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109536|NCT01736930|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109537|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109538|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109539|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109540|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109541|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109542|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109543|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109544|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109545|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109546|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109547|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109548|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109549|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109550|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109551|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109552|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109553|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109554|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109555|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109556|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109557|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109558|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109559|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109562|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109563|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109564|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109565|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109566|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109567|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109568|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109569|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109570|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109571|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109626|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109572|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109573|NCT01736930|E2|Reported Event|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
109574|NCT01736930|E1|Reported Event|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
109575|NCT01736917|B1|Baseline|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).
Acute emesis prophylaxis:
Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
Dexamethasone 20mg PO (orally) daily, D1 and 2
Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
Fosaprepitant 150mg IV on D5
Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
109576|NCT01736917|P1|Participant Flow|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).
Acute emesis prophylaxis:
Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
Dexamethasone 20mg PO (orally) daily, D1 and 2
Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
Fosaprepitant 150mg IV on D5
Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
109577|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).
Acute emesis prophylaxis:
Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
Dexamethasone 20mg PO (orally) daily, D1 and 2
Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
Fosaprepitant 150mg IV on D5
Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
109602|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109951|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109578|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).
Acute emesis prophylaxis:
Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
Dexamethasone 20mg PO (orally) daily, D1 and 2
Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
Fosaprepitant 150mg IV on D5
Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
109579|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).
Acute emesis prophylaxis:
Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
Dexamethasone 20mg PO (orally) daily, D1 and 2
Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
Fosaprepitant 150mg IV on D5
Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
109580|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).
Acute emesis prophylaxis:
Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
Dexamethasone 20mg PO (orally) daily, D1 and 2
Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
Fosaprepitant 150mg IV on D5
Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator
No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
109627|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109628|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109629|NCT01736696|O1|Outcome|All CP-690,550 Treated Participants|Included all participants who received either CP-690,550 OPC or CP-690,550 tablets for 14 days.
109581|NCT01736917|E1|Reported Event|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).
Acute emesis prophylaxis:
Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
Dexamethasone 20mg PO (orally) daily, D1 and 2
Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
Fosaprepitant 150mg IV on D5
Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
109582|NCT01736696|B8|Baseline|Total|Total of all reporting groups
109583|NCT01736696|B7|Baseline|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109584|NCT01736696|B6|Baseline|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109585|NCT01736696|B5|Baseline|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109586|NCT01736696|B4|Baseline|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109587|NCT01736696|B3|Baseline|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109588|NCT01736696|B2|Baseline|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109589|NCT01736696|B1|Baseline|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109590|NCT01736696|P7|Participant Flow|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109591|NCT01736696|P6|Participant Flow|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109592|NCT01736696|P5|Participant Flow|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109593|NCT01736696|P4|Participant Flow|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109594|NCT01736696|P3|Participant Flow|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109595|NCT01736696|P2|Participant Flow|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109596|NCT01736696|P1|Participant Flow|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109597|NCT01736696|O3|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109598|NCT01736696|O2|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109599|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109600|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109601|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109603|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109604|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109605|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109606|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109607|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109608|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109609|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109610|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109611|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109612|NCT01736696|O3|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109613|NCT01736696|O2|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109614|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109615|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109616|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109617|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109618|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109619|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109620|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109621|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109622|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109623|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109624|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109630|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109631|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109632|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109633|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109634|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109635|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109636|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109637|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109638|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109639|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109640|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109641|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109642|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109643|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109644|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109645|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109646|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109647|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109648|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109649|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109650|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109651|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109652|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109653|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109654|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109655|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109656|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
110070|NCT01736475|O2|Outcome|On-demand|
109657|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109658|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109659|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109660|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109661|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109662|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109663|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109664|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109665|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109666|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109667|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109668|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109669|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109670|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109671|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109672|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109673|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109674|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109675|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109676|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109677|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109678|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109679|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109680|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109681|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109682|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109683|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109684|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109685|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109686|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109687|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109688|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109689|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109690|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109691|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109692|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109693|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109694|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109695|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109696|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109697|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109698|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109699|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109700|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109701|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109702|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109703|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109704|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109705|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
110071|NCT01736475|O1|Outcome|Prophylaxis|Break-through bleeds during prophylaxis
109706|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109707|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109708|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109709|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109710|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109711|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109712|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109713|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109714|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109715|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109716|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109717|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109718|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109719|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109720|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109721|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109722|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109723|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109724|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109725|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109726|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109727|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109728|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109729|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109730|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109731|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109732|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109733|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109734|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109735|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109736|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109737|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109738|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109739|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109740|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109741|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109742|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109743|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109744|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109745|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109746|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109747|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109748|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109749|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109750|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109751|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109752|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109753|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109754|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
110199|NCT01735617|O1|Outcome|Chronocort|Chronocort Modified Release Capsules 10mg twice-daily
109755|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109756|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109757|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109758|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109759|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109760|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109761|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109762|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109763|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109764|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109765|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109766|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109767|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109768|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109769|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109770|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109771|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109772|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109773|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109774|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109775|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109776|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109777|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109778|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109779|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109780|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109781|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109782|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109783|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109784|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109785|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109786|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109787|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109788|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109789|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109790|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109791|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109792|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109793|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109794|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109795|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109796|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109797|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109798|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109799|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109800|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109801|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109802|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
110200|NCT01735617|O1|Outcome|Chroncort|Chronocort Modified Release Capsules 10mg twice-daily
109805|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109806|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109807|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109808|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109809|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109810|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109811|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109812|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109813|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109814|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109815|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109816|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109817|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109818|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109819|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109820|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109821|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109822|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109823|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109824|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109875|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109825|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109826|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109827|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109828|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109829|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109830|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109831|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109832|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109833|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109834|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109835|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109836|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109837|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109838|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109839|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109840|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109841|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109842|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109843|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109844|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109845|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109846|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109847|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109848|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109849|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109850|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109851|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109852|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109853|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109854|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109855|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109856|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109857|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109858|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109859|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109860|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109861|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109862|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109863|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109864|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109865|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109866|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109867|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109868|NCT01736696|O2|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109869|NCT01736696|O1|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109870|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109871|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109872|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109873|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109874|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109876|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109877|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109878|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109879|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109880|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109881|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109882|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109883|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109884|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109885|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109886|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109887|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109888|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109889|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109890|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109891|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109892|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109893|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109894|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109895|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109896|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109897|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109898|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109899|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109900|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109901|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109902|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109903|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109904|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109905|NCT01736696|E7|Reported Event|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
109906|NCT01736696|E6|Reported Event|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
109907|NCT01736696|E5|Reported Event|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
109908|NCT01736696|E4|Reported Event|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
109909|NCT01736696|E3|Reported Event|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
109910|NCT01736696|E2|Reported Event|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
109911|NCT01736696|E1|Reported Event|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
109912|NCT01736657|B1|Baseline|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
109913|NCT01736657|P1|Participant Flow|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
109914|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
109915|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
109916|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
109917|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
109918|NCT01736657|E1|Reported Event|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
109919|NCT01736579|B3|Baseline|Total|Total of all reporting groups
109920|NCT01736579|B2|Baseline|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109921|NCT01736579|B1|Baseline|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109922|NCT01736579|P2|Participant Flow|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109923|NCT01736579|P1|Participant Flow|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109924|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109925|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109926|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109927|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109928|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109929|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109930|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109931|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109932|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109933|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109934|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109935|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109936|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109937|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109938|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109939|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109940|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109941|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109942|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109943|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109944|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109945|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109946|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109947|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109948|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109949|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109952|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
109953|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
109954|NCT01736579|E2|Reported Event|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks.
109955|NCT01736579|E1|Reported Event|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks.
109956|NCT01736540|B1|Baseline|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109957|NCT01736540|P1|Participant Flow|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109958|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109959|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
109960|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
109961|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
109962|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
109963|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109964|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
109965|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
109966|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
109967|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
109968|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109969|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
109970|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
109971|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
109973|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109974|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
109975|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
109976|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
109977|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
109978|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109979|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
109980|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
109981|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
109982|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
109983|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109984|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109985|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109986|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109987|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109988|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109989|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
109990|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
109991|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
109992|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
109993|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109994|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
109995|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
109996|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
109997|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
109998|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
109999|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
110000|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
110001|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
110002|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
110003|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
110004|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
110005|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
110006|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
110007|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
110008|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
110009|NCT01736540|E4|Reported Event|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
110010|NCT01736540|E3|Reported Event|Other Anaemia|Subset of overall participants with other types of anaemias
110011|NCT01736540|E2|Reported Event|Myelodysplastic Syndrome (MDS)|Subset of overall participants with MDS
110012|NCT01736540|E1|Reported Event|Thalassaemia Major|Subset of overall participants with thalassemia major
110013|NCT01736527|B1|Baseline|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.
LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
110014|NCT01736527|P1|Participant Flow|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.
LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
110015|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.
LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
110016|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.
LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
110017|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.
LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
110018|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.
LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
110019|NCT01736527|E1|Reported Event|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.
LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
110020|NCT01736475|B3|Baseline|Total|Total of all reporting groups
110021|NCT01736475|B2|Baseline|On-demand|
110022|NCT01736475|B1|Baseline|Prophylaxis|
110023|NCT01736475|P2|Participant Flow|On-demand|10 to 60 ± 5 IU/kg
110024|NCT01736475|P1|Participant Flow|Prophylaxis|Twice weekly at a dose of 45 ± 5 IU/kg
110025|NCT01736475|O2|Outcome|On-demand|
110026|NCT01736475|O1|Outcome|Prophylaxis|
110027|NCT01736475|O2|Outcome|On-demand|
110028|NCT01736475|O1|Outcome|Prophylaxis|
110029|NCT01736475|O2|Outcome|On-demand|
110030|NCT01736475|O1|Outcome|Prophylaxis|
110031|NCT01736475|O2|Outcome|On-demand|
110032|NCT01736475|O1|Outcome|Prophylaxis|
110033|NCT01736475|O2|Outcome|On-demand|
110034|NCT01736475|O1|Outcome|Prophylaxis|
110035|NCT01736475|O2|Outcome|On-demand|
110036|NCT01736475|O1|Outcome|Prophylaxis|
110037|NCT01736475|O2|Outcome|On-demand|
110038|NCT01736475|O1|Outcome|Prophylaxis|
110039|NCT01736475|O2|Outcome|On-demand|
110040|NCT01736475|O1|Outcome|Prophylaxis|
110041|NCT01736475|O2|Outcome|On-demand|
110042|NCT01736475|O1|Outcome|Prophylaxis|
110043|NCT01736475|O2|Outcome|On-demand|
110044|NCT01736475|O1|Outcome|Prophylaxis|
110045|NCT01736475|O2|Outcome|On-deamand|
110046|NCT01736475|O1|Outcome|Prophylaxis|
110047|NCT01736475|O2|Outcome|On-demand|
110048|NCT01736475|O1|Outcome|Prophylaxis|
110049|NCT01736475|O2|Outcome|On-demand|
110050|NCT01736475|O1|Outcome|Prophylaxis|
110051|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
110052|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
110053|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
110054|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
110055|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
110056|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
110057|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
110058|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
110059|NCT01736475|O2|Outcome|On-demand|Participants with both baseline and study completion SF-36 Scores
110060|NCT01736475|O1|Outcome|Prophylaxis|Participants with both baseline and study completion SF-36 Scores
110061|NCT01736475|O2|Outcome|On-demand|Participants with both baseline and study completion HAEMO-SYM scores
110062|NCT01736475|O1|Outcome|Prophylaxis|Participants with both baseline and study completion HAEMO-SYM scores
110063|NCT01736475|O2|Outcome|On-demand|10 to 60 ± 5 IU/kg
110064|NCT01736475|O1|Outcome|Prophylaxis|Twice weekly at a dose of 45 ± 5 IU/kg
110065|NCT01736475|O1|Outcome|All Study Participants|All Study Participants who received at least one infusion of BAX855.
110066|NCT01736475|O1|Outcome|All Study Participants|All Study Participants who received at least one infusion of BAX855.
110067|NCT01736475|O1|Outcome|All Study Participants|
110068|NCT01736475|O2|Outcome|On-demand|
110069|NCT01736475|O1|Outcome|Prophylaxis|
110072|NCT01736475|O1|Outcome|Participants With a Bleeding Episode|All bleeding episodes treated with BAX 855 in participants on on-demand and prophylaxis treatment regimens.
110073|NCT01736475|O2|Outcome|On-demand|
110074|NCT01736475|O1|Outcome|Prophylaxis|
110075|NCT01736475|E1|Reported Event|All Study Participants|All study participants were analyzed in a single arm/group.
110076|NCT01736215|B1|Baseline|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110077|NCT01736215|P1|Participant Flow|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110078|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110079|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110080|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110081|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110082|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110251|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
110083|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110084|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110085|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110086|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110087|NCT01736215|E1|Reported Event|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
110088|NCT01736176|B1|Baseline|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110089|NCT01736176|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|Participants had a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually. The starting total daily dose of LCIG was based solely on the daily dose of the oral levodopa taken immediately prior to Day 1 and was adjusted to obtain the optimal clinical response for the individual participant. Participants received treatment for up to 60 weeks; participants who completed their Week 60 visit before LCIG was commercially available had the option to extend their LCIG therapy, if in the opinion of the investigator, the participant would benefit from continued LCIG treatment.
110090|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110091|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110092|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110093|NCT01736176|O2|Outcome|Week 60|
110094|NCT01736176|O1|Outcome|Week 12|
110095|NCT01736176|O2|Outcome|Week 60|
110096|NCT01736176|O1|Outcome|Week 12|
110097|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110201|NCT01735617|O1|Outcome|Chronocort|Chronocort Modified Release Capsules 10 mg twice-daily.
110098|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110099|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110100|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110101|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110102|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110103|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110252|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
110104|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110105|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110106|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110107|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110108|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110109|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110110|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110111|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110112|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110113|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110114|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110115|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110116|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110117|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110118|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110119|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110120|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110253|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
110121|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110122|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110123|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110124|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110125|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110126|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110127|NCT01736176|O2|Outcome|Overall|Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure and no more than 30 days after the end of the LCIG Treatment Period.
110128|NCT01736176|O1|Outcome|Week 1-4|Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure through week 4.
110129|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110130|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110131|NCT01736176|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
110132|NCT01735916|B4|Baseline|Total|Total of all reporting groups
110133|NCT01735916|B3|Baseline|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
110231|NCT01735201|B2|Baseline|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
110134|NCT01735916|B2|Baseline|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
110135|NCT01735916|B1|Baseline|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
110136|NCT01735916|P3|Participant Flow|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
110137|NCT01735916|P2|Participant Flow|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
110138|NCT01735916|P1|Participant Flow|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
110139|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
110140|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
110141|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
110142|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
110143|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
110254|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
110144|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
110145|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
110146|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
110147|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
110148|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
110149|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
110150|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
110151|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
110152|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
110153|NCT01735916|E3|Reported Event|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
110154|NCT01735916|E2|Reported Event|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
110155|NCT01735916|E1|Reported Event|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
110156|NCT01735877|B3|Baseline|Total|Total of all reporting groups
110157|NCT01735877|B2|Baseline|Control Group|"Group 2 will be given sham mirror therapy
Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
110158|NCT01735877|B1|Baseline|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
110159|NCT01735877|P2|Participant Flow|Control Group|"Group 2 will be given sham mirror therapy
Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
110160|NCT01735877|P1|Participant Flow|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
110161|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy
Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
110162|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
110163|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy
Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
110255|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
110256|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
110164|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
110165|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy
Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
110166|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
110167|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy
Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
110168|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
110169|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy
Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
110170|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
110171|NCT01735877|E2|Reported Event|Control Group|"Group 2 will be given sham mirror therapy
Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
110232|NCT01735201|B1|Baseline|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
110233|NCT01735201|P8|Participant Flow|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
110172|NCT01735877|E1|Reported Event|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
110173|NCT01735630|B3|Baseline|Total|Total of all reporting groups
110174|NCT01735630|B2|Baseline|Placebo|"Matched placebo BID for 12 weeks
Placebo"
110175|NCT01735630|B1|Baseline|ELND005|"ELND005 film coated tablets, BID for 12 weeks
ELND005"
110176|NCT01735630|P2|Participant Flow|Placebo|"Matched placebo BID for 12 weeks
Placebo"
110177|NCT01735630|P1|Participant Flow|ELND005|"ELND005 film coated tablets, BID for 12 weeks
ELND005"
110178|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks
Placebo"
110179|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks
ELND005"
110180|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks
Placebo"
110181|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks
ELND005"
110182|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks
Placebo"
110183|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks
ELND005"
110184|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks
Placebo"
110185|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks
ELND005"
110186|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks
Placebo"
110187|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks
ELND005"
110188|NCT01735630|E2|Reported Event|Placebo|"Matched placebo BID for 12 weeks
Placebo"
110189|NCT01735630|E1|Reported Event|ELND005|"ELND005 film coated tablets, BID for 12 weeks
ELND005"
110190|NCT01735617|B1|Baseline|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
110257|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
110191|NCT01735617|P1|Participant Flow|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
110192|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
110193|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
110194|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
110195|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
110196|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
110197|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
110198|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
110202|NCT01735617|E1|Reported Event|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
110203|NCT01735396|B1|Baseline|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
110204|NCT01735396|P1|Participant Flow|Abiraterone Acetate|"Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.
Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily"
110205|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
110206|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
110207|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
110208|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
110209|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
110210|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
110211|NCT01735396|E1|Reported Event|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
110212|NCT01735214|B1|Baseline|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110213|NCT01735214|P1|Participant Flow|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110214|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110215|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110216|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110217|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110218|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110219|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110220|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110221|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110222|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110223|NCT01735214|E1|Reported Event|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
110224|NCT01735201|B9|Baseline|Total|Total of all reporting groups
110225|NCT01735201|B8|Baseline|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
110226|NCT01735201|B7|Baseline|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
110227|NCT01735201|B6|Baseline|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
110228|NCT01735201|B5|Baseline|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
110229|NCT01735201|B4|Baseline|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
110230|NCT01735201|B3|Baseline|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
110234|NCT01735201|P7|Participant Flow|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
110235|NCT01735201|P6|Participant Flow|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
110236|NCT01735201|P5|Participant Flow|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
110237|NCT01735201|P4|Participant Flow|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
110238|NCT01735201|P3|Participant Flow|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
110239|NCT01735201|P2|Participant Flow|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
110240|NCT01735201|P1|Participant Flow|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
110241|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
110242|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
110243|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
110244|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
110245|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
110246|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
110247|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
110248|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
110249|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
110250|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
110258|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
110259|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
110260|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
110261|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
110262|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
110263|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
110264|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
110265|NCT01735201|E8|Reported Event|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
110266|NCT01735201|E7|Reported Event|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
110267|NCT01735201|E6|Reported Event|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
110268|NCT01735201|E5|Reported Event|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
110269|NCT01735201|E4|Reported Event|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
110270|NCT01735201|E3|Reported Event|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
110271|NCT01735201|E2|Reported Event|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
110272|NCT01735201|E1|Reported Event|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
110273|NCT01735175|B3|Baseline|Total|Total of all reporting groups
110274|NCT01735175|B2|Baseline|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110275|NCT01735175|B1|Baseline|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110276|NCT01735175|P2|Participant Flow|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110277|NCT01735175|P1|Participant Flow|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110278|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110279|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110280|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110281|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110365|NCT01734772|O1|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
110282|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110283|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110284|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110285|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110286|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110287|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110288|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110405|NCT01734239|E1|Reported Event|Pneumovax™ 23|Participants received a single 0.5 mL intramuscular injection on Day 1
110289|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110290|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110291|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110292|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110293|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110294|NCT01735175|E2|Reported Event|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110295|NCT01735175|E1|Reported Event|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
110296|NCT01734993|B1|Baseline|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110297|NCT01734993|P1|Participant Flow|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 long term extension (LTE) study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of greater than [>] 1.2 points) were administered tocilizumab (TCZ) in this long-term extension study, at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110298|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110299|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110300|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110301|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110302|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110303|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110304|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110305|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110406|NCT01734161|B3|Baseline|Total|Total of all reporting groups
110306|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110307|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110308|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110309|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110310|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110311|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110312|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110313|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110314|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110315|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110316|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110317|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110318|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110319|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110320|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110321|NCT01734993|E1|Reported Event|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
110322|NCT01734889|B1|Baseline|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
110323|NCT01734889|P1|Participant Flow|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
110324|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
110325|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
110326|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
110327|NCT01734889|O1|Outcome|Age <5 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
110328|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
110329|NCT01734889|E1|Reported Event|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
110330|NCT01734785|B4|Baseline|Total|Total of all reporting groups
110331|NCT01734785|B3|Baseline|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110332|NCT01734785|B2|Baseline|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110333|NCT01734785|B1|Baseline|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110334|NCT01734785|P4|Participant Flow|Linagliptin 5 mg|Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
110335|NCT01734785|P3|Participant Flow|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110336|NCT01734785|P2|Participant Flow|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110337|NCT01734785|P1|Participant Flow|Empagliflozin 25 mg|Patients received 1 fixed dose combination (FDC) Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110338|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110364|NCT01734772|O2|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
110339|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110340|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110341|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110342|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110343|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110344|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110345|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110346|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110407|NCT01734161|B2|Baseline|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Placebo: Subjects randomized to placebo receive 50cc normal saline"
110347|NCT01734785|E4|Reported Event|Linagliptin 5 mg|Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
110348|NCT01734785|E3|Reported Event|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110349|NCT01734785|E2|Reported Event|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110350|NCT01734785|E1|Reported Event|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
110351|NCT01734772|B3|Baseline|Total|Total of all reporting groups
110352|NCT01734772|B2|Baseline|Part 2|In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.
110353|NCT01734772|B1|Baseline|Part 1|In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
110354|NCT01734772|P2|Participant Flow|Part 2|In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.
110355|NCT01734772|P1|Participant Flow|Part 1|In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
110356|NCT01734772|O5|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
110357|NCT01734772|O4|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
110358|NCT01734772|O3|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg in the morning on day 4.
110359|NCT01734772|O2|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
110360|NCT01734772|O1|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
110361|NCT01734772|O5|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
110362|NCT01734772|O4|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
110363|NCT01734772|O3|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg in the morning on day 4.
110390|NCT01734239|B3|Baseline|Total|Total of all reporting groups
110366|NCT01734772|E5|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
110367|NCT01734772|E4|Reported Event|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
110368|NCT01734772|E3|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg once on day 4.
110369|NCT01734772|E2|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
110370|NCT01734772|E1|Reported Event|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
110371|NCT01734655|B1|Baseline|All Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
110372|NCT01734655|P1|Participant Flow|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices in either a focus group format (the first 11 participants) or cognitive interview format (the last 29 participants).
110408|NCT01734161|B1|Baseline|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
Dexamethasone: 8mg IV dexamethesone given"
110373|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
110374|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
110375|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
110376|NCT01734655|O1|Outcome|All Participants|all participants
110377|NCT01734655|O1|Outcome|All Participants|All Participants
110378|NCT01734655|O1|Outcome|All Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
110379|NCT01734655|E1|Reported Event|All Participants|Pregnant women who were overweight or obese and 18-40 yrs of age.
110380|NCT01734395|B1|Baseline|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
110381|NCT01734395|P1|Participant Flow|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
110382|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
110383|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
110384|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
110385|NCT01734395|E1|Reported Event|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
110386|NCT01734317|B1|Baseline|Mepilex Transfer Ag|
110387|NCT01734317|P1|Participant Flow|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Mepilex Transfer Ag: A soft silicone wound contact layer."
110388|NCT01734317|O1|Outcome|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Mepilex Transfer Ag: A soft silicone wound contact layer."
110389|NCT01734317|E1|Reported Event|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Mepilex Transfer Ag: A soft silicone wound contact layer."
110391|NCT01734239|B2|Baseline|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110392|NCT01734239|B1|Baseline|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110393|NCT01734239|P2|Participant Flow|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110394|NCT01734239|P1|Participant Flow|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110395|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110396|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110397|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110398|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110399|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110400|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110401|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110402|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110403|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110404|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
110409|NCT01734161|P2|Participant Flow|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Placebo: Subjects randomized to placebo receive 50cc normal saline"
110410|NCT01734161|P1|Participant Flow|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
Dexamethasone: 8mg IV dexamethesone given"
110411|NCT01734161|O2|Outcome|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Placebo: Subjects randomized to placebo receive 50cc normal saline"
110412|NCT01734161|O1|Outcome|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
Dexamethasone: 8mg IV dexamethesone given"
110413|NCT01734161|E2|Reported Event|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Placebo: Subjects randomized to placebo receive 50cc normal saline"
110414|NCT01734161|E1|Reported Event|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
Dexamethasone: 8mg IV dexamethesone given"
110415|NCT01733953|B3|Baseline|Total|Total of all reporting groups
110416|NCT01733953|B2|Baseline|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily
Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
110417|NCT01733953|B1|Baseline|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily
Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
110418|NCT01733953|P2|Participant Flow|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily
Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
110419|NCT01733953|P1|Participant Flow|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily
Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
110420|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily
Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
110421|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily
Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
110422|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily
Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
110423|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily
Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
110424|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily
Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
110425|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily
Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
110426|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily
Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
110427|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily
Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
110428|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily
Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
110429|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily
Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
110430|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily
Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
110431|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily
Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
110432|NCT01733953|E2|Reported Event|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily
Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
110433|NCT01733953|E1|Reported Event|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily
Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
110434|NCT01733758|B5|Baseline|Total|Total of all reporting groups
110435|NCT01733758|B4|Baseline|Open Label Liraglutide 0.9 mg Daily|Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110436|NCT01733758|B3|Baseline|Albiglutide 50 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110437|NCT01733758|B2|Baseline|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110438|NCT01733758|B1|Baseline|Placebo|Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110439|NCT01733758|P4|Participant Flow|Open Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110440|NCT01733758|P3|Participant Flow|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110441|NCT01733758|P2|Participant Flow|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110442|NCT01733758|P1|Participant Flow|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly to Week 52.
110443|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110444|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110445|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110446|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110447|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110448|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110449|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110450|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110451|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110452|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110453|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110454|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110455|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110456|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110457|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110458|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110459|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110460|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110461|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110462|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110463|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110464|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110465|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110466|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110467|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110468|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110469|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110470|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110471|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110472|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110473|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110474|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110475|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110476|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110477|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110478|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110479|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110480|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110481|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110482|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110483|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110484|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110485|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110486|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110487|NCT01733758|E5|Reported Event|Open Label Liraglutide 0.9 mg Daily|Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
110488|NCT01733758|E4|Reported Event|Albiglutide 50 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
110489|NCT01733758|E3|Reported Event|Albiglutide 30 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110490|NCT01733758|E2|Reported Event|Placebo - After Switch|(After Switch to 30 mg algiblutide) After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
110491|NCT01733758|E1|Reported Event|Placebo - Before Switch|(Before Switch to 30 mg albiglutide) Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24.
110492|NCT01733745|B3|Baseline|Total|Total of all reporting groups
110493|NCT01733745|B2|Baseline|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
110494|NCT01733745|B1|Baseline|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
110569|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
110495|NCT01733745|P2|Participant Flow|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
110496|NCT01733745|P1|Participant Flow|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
110497|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
110498|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
110499|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
110500|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
110501|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
110502|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
110503|NCT01733745|E2|Reported Event|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
110588|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)
MRI"
110504|NCT01733745|E1|Reported Event|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
110505|NCT01733732|B3|Baseline|Total|Total of all reporting groups
110506|NCT01733732|B2|Baseline|Systane Gel|One drop in each eye 4 times a day for 30 days
110507|NCT01733732|B1|Baseline|Systane Balance|One drop in each eye 4 times a day for 30 days
110508|NCT01733732|P2|Participant Flow|Systane Gel|One drop in each eye 4 times a day for 30 days
110509|NCT01733732|P1|Participant Flow|Systane Balance|One drop in each eye 4 times a day for 30 days
110510|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
110511|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
110512|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
110513|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
110514|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
110515|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
110516|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
110517|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
110518|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
110519|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
110520|NCT01733732|O4|Outcome|Systane Gel, Change From Baseline at Day 30|One drop in each eye 4 times a day for 30 days
110521|NCT01733732|O3|Outcome|Systane Gel, Change From Baseline at Day 14|One drop in each eye 4 times a day for 30 days
110522|NCT01733732|O2|Outcome|Systane Balance, Change From Baseline at Day 30|One drop in each eye 4 times a day for 30 days
110523|NCT01733732|O1|Outcome|Systane Balance, Change From Baseline at Day 14|One drop in each eye 4 times a day for 30 days
110524|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
110525|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
110526|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
110527|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
110528|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
110529|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
110530|NCT01733732|O6|Outcome|Systane Gel, Day 30|One drop in each eye 4 times a day for 30 days
110531|NCT01733732|O5|Outcome|Systane Gel, Day 14|One drop in each eye 4 times a day for 30 days
110532|NCT01733732|O4|Outcome|Systane Gel, Day 0|One drop in each eye 4 times a day for 30 days
110533|NCT01733732|O3|Outcome|Systane Balance, Day 30|One drop in each eye 4 times a day for 30 days
110534|NCT01733732|O2|Outcome|Systane Balance, Day 14|One drop in each eye 4 times a day for 30 days
110535|NCT01733732|O1|Outcome|Systane Balance, Day 0|One drop in each eye 4 times a day for 30 days
110536|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
110537|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
110538|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
110539|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
110540|NCT01733732|E2|Reported Event|Systane Gel|One drop in each eye 4 times a day for 30 days
110541|NCT01733732|E1|Reported Event|Systane Balance|One drop in each eye 4 times a day for 30 days
110542|NCT01733329|B3|Baseline|Total|Total of all reporting groups
110570|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
110571|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
110543|NCT01733329|B2|Baseline|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist . The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Placebo"
110544|NCT01733329|B1|Baseline|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Misoprostol"
110545|NCT01733329|P2|Participant Flow|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Placebo"
110546|NCT01733329|P1|Participant Flow|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=62) or placebo (n=61) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Misoprostol"
110547|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Placebo"
110548|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Misoprostol"
110549|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Placebo"
110589|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI"
110550|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Misoprostol"
110551|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Placebo"
110552|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Misoprostol"
110553|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Placebo"
110554|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Misoprostol"
110555|NCT01733329|E2|Reported Event|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Placebo"
110556|NCT01733329|E1|Reported Event|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Misoprostol"
110557|NCT01733316|B1|Baseline|All Participants|"From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
During Months 3.5, 4, 5, 6, 7 and for the remainder of study: participants received RP103 Q12H."
110558|NCT01733316|P1|Participant Flow|All Participants|"From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® every 6 hours (Q6H).
During Months 3.5, 4, 5, 6, 7 and for the remainder of study: participants received RP103 every 12 hours (Q12H)."
110559|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
110560|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
110561|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
110562|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
110563|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
110564|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
110565|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
110566|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
110567|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
110568|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
110573|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
110574|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
110575|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
110576|NCT01733316|E3|Reported Event|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
110577|NCT01733316|E2|Reported Event|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
110578|NCT01733316|E1|Reported Event|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
110579|NCT01733277|B3|Baseline|Total|Total of all reporting groups
110580|NCT01733277|B2|Baseline|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)
MRI"
110581|NCT01733277|B1|Baseline|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI"
110582|NCT01733277|P2|Participant Flow|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)
MRI"
110583|NCT01733277|P1|Participant Flow|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI"
110584|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)
MRI"
110585|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI"
110586|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)
MRI"
110587|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI"
110590|NCT01733277|E2|Reported Event|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)
MRI"
110591|NCT01733277|E1|Reported Event|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI"
110592|NCT01732263|B3|Baseline|Total|Total of all reporting groups
110593|NCT01732263|B2|Baseline|Matched Healthy Subjects|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110594|NCT01732263|B1|Baseline|Hepatic Impairment|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110595|NCT01732263|P2|Participant Flow|Matched Healthy Subjects|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110596|NCT01732263|P1|Participant Flow|Hepatic Impairment|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110597|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110598|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110599|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110600|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110601|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110602|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110603|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110604|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110636|NCT01733121|B2|Baseline|Valbenazine|Participants received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
110637|NCT01733121|B1|Baseline|Placebo|Participants received Placebo capsule (matching valbenazine capsules) daily for 6 weeks.
110605|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110606|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110607|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110608|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110609|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110610|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110611|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110612|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110613|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110614|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110615|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110616|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110617|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110618|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110619|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110620|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110621|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110622|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110623|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110624|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110625|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110626|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110627|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110628|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
110629|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110630|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110631|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110632|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
110638|NCT01733121|P2|Participant Flow|Valbenazine|Participants could receive valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks); flexible dose escalation.
110639|NCT01733121|P1|Participant Flow|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
110640|NCT01733121|O2|Outcome|Valbenazine|Participants first received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
110641|NCT01733121|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
110642|NCT01733121|O2|Outcome|NBI-98854|Participants first received NBI-98854 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
110643|NCT01733121|O1|Outcome|Placebo|Participants received Placebo capsule (matching NBI-98854 capsules) once daily for 6 weeks.
110644|NCT01733121|O2|Outcome|Valbenazine|Participants first received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
110645|NCT01733121|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
110646|NCT01733121|O2|Outcome|Valbenazine|Participants first received valbenazine 25mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks).
110647|NCT01733121|O1|Outcome|Placebo|Participants received Placebo capsule (matching valbenazine capsules) once daily for 6 weeks.
110648|NCT01733121|E2|Reported Event|Valbenazine|Participants first received valbenazine 5mg once daily for 2 weeks, then 50mg once daily for 2 weeks, then 75mg once daily for 2 weeks (a total of 6 weeks) followed by 2 weeks posttreatment period.
110649|NCT01733121|E1|Reported Event|Placebo|Participants received Placebo capsule (matching valbenazine capsules) daily for 6 weeks followed by 2 weeks posttreatment period.
110650|NCT01733069|B3|Baseline|Total|Total of all reporting groups
110651|NCT01733069|B2|Baseline|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
110652|NCT01733069|B1|Baseline|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
110653|NCT01733069|P2|Participant Flow|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
110654|NCT01733069|P1|Participant Flow|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses.
110655|NCT01733069|O2|Outcome|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
110656|NCT01733069|O1|Outcome|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
110657|NCT01733069|E2|Reported Event|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses
110694|NCT01732926|E1|Reported Event|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110658|NCT01733069|E1|Reported Event|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses
110659|NCT01733056|B4|Baseline|Total|Total of all reporting groups
110660|NCT01733056|B3|Baseline|TNF Alpha Blocker|Patients with skin diseases taking TNF alpha blockers
110661|NCT01733056|B2|Baseline|Azathioprine|Patients with skin diseases taking azathioprine
110662|NCT01733056|B1|Baseline|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
110663|NCT01733056|P3|Participant Flow|TNF Alpha Blockers|
110664|NCT01733056|P2|Participant Flow|Azathioprine|
110665|NCT01733056|P1|Participant Flow|Healthy Volunteer|
110666|NCT01733056|O3|Outcome|TNF Alpha Blockers|Patients with skin diseases taking TNF alpha blockers
110667|NCT01733056|O2|Outcome|Azathioprine|Patients with skin diseases taking azathioprine
110668|NCT01733056|O1|Outcome|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
110669|NCT01733056|O3|Outcome|TNF Alpha Blockers|Patients with skin diseases taking TNF alpha blockers
110670|NCT01733056|O2|Outcome|Azathioprine|Patients with skin diseases taking azathioprine
110671|NCT01733056|O1|Outcome|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
113709|NCT01717989|O5|Outcome|December 2011|
110672|NCT01733056|E6|Reported Event|TNF Alpha Blocker Post-vaccination|Patients with skin disease treated with TNF blockers who had blood drawn after vaccination with influenza vaccine
110673|NCT01733056|E5|Reported Event|TNF Alpha Blocker Pre-vaccination|Patients with skin disease treated with TNF blockers who had blood drawn prior to vaccination with influenza vaccine
110674|NCT01733056|E4|Reported Event|Azathioprine Post-vaccination|Patients with skin disease treated with azathioprine who had blood drawn after vaccination with influenza vaccine
110675|NCT01733056|E3|Reported Event|Azathioprine Pre-vaccination|Patients with skin disease treated with azathioprine who had blood drawn prior to vaccination with influenza vaccine
110676|NCT01733056|E2|Reported Event|Healthy Volunteer Post-vaccination|Healthy volunteers who had blood drawn after vaccination with influenza vaccine
110677|NCT01733056|E1|Reported Event|Healthy Volunteer Pre-vaccination|Healthy volunteers who had blood drawn prior to vaccination with influenza vaccine
110678|NCT01732926|B3|Baseline|Total|Total of all reporting groups
110679|NCT01732926|B2|Baseline|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110680|NCT01732926|B1|Baseline|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110681|NCT01732926|P2|Participant Flow|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110682|NCT01732926|P1|Participant Flow|Idelalisib + Bendamustine + Rituximab|"Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions)
+ rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)"
110683|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110684|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110685|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110686|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110687|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110688|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110689|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110690|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110691|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110692|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110693|NCT01732926|E2|Reported Event|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
110695|NCT01732913|B3|Baseline|Total|Total of all reporting groups
110696|NCT01732913|B2|Baseline|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110697|NCT01732913|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110698|NCT01732913|P2|Participant Flow|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110699|NCT01732913|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110700|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110701|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110702|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110703|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110704|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110705|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110706|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110707|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110708|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110709|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110710|NCT01732913|E2|Reported Event|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110711|NCT01732913|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
110712|NCT01732835|B1|Baseline|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110713|NCT01732835|P1|Participant Flow|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110714|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110715|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110716|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110717|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110718|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110719|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110720|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110721|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110722|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110723|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110724|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110725|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110726|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110727|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110728|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110729|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110730|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110731|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110732|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110733|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110734|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110735|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110736|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110806|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110737|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110738|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110739|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110740|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110741|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110742|NCT01732835|E1|Reported Event|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
110743|NCT01732796|B4|Baseline|Total|Total of all reporting groups
110744|NCT01732796|B3|Baseline|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
110745|NCT01732796|B2|Baseline|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
110746|NCT01732796|B1|Baseline|16 wk NC FDV+DBV+RBV|"600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).
This group included non-cirrhotic patients (NC)."
110747|NCT01732796|P3|Participant Flow|24 wk CR FDV+DBV+RBV|600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
110748|NCT01732796|P2|Participant Flow|24 wk NC FDV+DBV+RBV|"600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally).
This group included non-cirrhotic patients (NC)."
110749|NCT01732796|P1|Participant Flow|16 wk NC FDV+DBV+RBV|"600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin BID (RBV) for 16 weeks (wk) followed by DBV placebo, FDV placebo and RBV placebo for 8 weeks. All were administered per os (orally).
This group included non-cirrhotic patients (NC)."
110750|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
110751|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
110752|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
110753|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
110754|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
110755|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
110756|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
110757|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
110793|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110758|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
110759|NCT01732796|O2|Outcome|16 wk FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID), orally. This is the combination of non-cirrhotic patients in the 16 week treatment group and cirrhosis patients in the 24-week treatment group.
110760|NCT01732796|O1|Outcome|24 wk FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk (orally) in cirrhotic and non-cirrhotic patients.
110761|NCT01732796|E3|Reported Event|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
110762|NCT01732796|E2|Reported Event|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
110763|NCT01732796|E1|Reported Event|16 wk NC FDV+DBV+RBV|"600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).
This group included non-cirrhotic patients (NC)."
110764|NCT01732770|B3|Baseline|Total|Total of all reporting groups
110765|NCT01732770|B2|Baseline|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
110807|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110766|NCT01732770|B1|Baseline|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
110767|NCT01732770|P2|Participant Flow|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
110768|NCT01732770|P1|Participant Flow|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
110769|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
110770|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
110771|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
110772|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
110773|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
110774|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
110775|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
110776|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
110777|NCT01732770|E2|Reported Event|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
110778|NCT01732770|E1|Reported Event|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
110779|NCT01732757|B4|Baseline|Total|Total of all reporting groups
110780|NCT01732757|B3|Baseline|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110781|NCT01732757|B2|Baseline|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110782|NCT01732757|B1|Baseline|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110783|NCT01732757|P3|Participant Flow|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110784|NCT01732757|P2|Participant Flow|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110785|NCT01732757|P1|Participant Flow|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110786|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110787|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110788|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110789|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110790|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110791|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110792|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110794|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110795|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110796|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110797|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110798|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110799|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110800|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110801|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110802|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110803|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110804|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110805|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110808|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110809|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110810|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110811|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110812|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110813|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110814|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110815|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110816|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110817|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110818|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110819|NCT01732757|E3|Reported Event|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
110820|NCT01732757|E2|Reported Event|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
110821|NCT01732757|E1|Reported Event|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
110822|NCT01732692|B3|Baseline|Total|Total of all reporting groups
110823|NCT01732692|B2|Baseline|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
110824|NCT01732692|B1|Baseline|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
110825|NCT01732692|P2|Participant Flow|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
110826|NCT01732692|P1|Participant Flow|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
110827|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
110828|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
110829|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
110830|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
110831|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
110832|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
110833|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
110834|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
110835|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
110836|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
110837|NCT01732692|E2|Reported Event|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
110838|NCT01732692|E1|Reported Event|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
110839|NCT01732588|B4|Baseline|Total|Total of all reporting groups
110840|NCT01732588|B3|Baseline|Sequence 3|Subjects received a single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A); then 120 mg OZ439 IR caplet (Regimen B).
110841|NCT01732588|B2|Baseline|Sequence 2|Subjects received a single dose of 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A)
110842|NCT01732588|B1|Baseline|Sequence 1|Subjects received a single dose of 120 mg OZ439 PIB oral suspension (Regimen A), then 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C)
110843|NCT01732588|P3|Participant Flow|Sequence 3|Subjects received a single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A); then 120 mg OZ439 IR caplet (Regimen B).
110879|NCT01732549|E2|Reported Event|Placebo|"1 capsule daily, taken orally with water and food until disease progression
Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
110844|NCT01732588|P2|Participant Flow|Sequence 2|Subjects received a single dose of 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A).
110845|NCT01732588|P1|Participant Flow|Sequence 1|Subjects received a single dose of 120 mg OZ439 PIB oral suspension (Regimen A), then 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C)
110846|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
110847|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
110848|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
110849|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
110850|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
110851|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
110852|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
110853|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
110854|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
110855|NCT01732588|E3|Reported Event|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate administered orally via the Enterion capsule
110856|NCT01732588|E2|Reported Event|Regimen B - 120 mg OZ439 IR Caplet|Single oral dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
110857|NCT01732588|E1|Reported Event|Regimen A - 120mg OZ439 PIB|Single oral dose of 120 mg OZ439 as powder in bottle (PIB) formulation.
110858|NCT01732549|B3|Baseline|Total|Total of all reporting groups
110859|NCT01732549|B2|Baseline|Placebo|"1 capsule daily, taken orally with water and food until disease progression
Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
110860|NCT01732549|B1|Baseline|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
110861|NCT01732549|P2|Participant Flow|Placebo|"1 capsule daily, taken orally with water and food until disease progression
Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
110862|NCT01732549|P1|Participant Flow|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
110863|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
110864|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
110865|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
110866|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
110867|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
110868|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
110869|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
110870|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
110871|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
110872|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
110873|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
110874|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression
110875|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
110876|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression
110877|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
110878|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
110925|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110880|NCT01732549|E1|Reported Event|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
110881|NCT01732510|B8|Baseline|Total|Total of all reporting groups
110882|NCT01732510|B7|Baseline|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110883|NCT01732510|B6|Baseline|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110884|NCT01732510|B5|Baseline|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
110885|NCT01732510|B4|Baseline|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110886|NCT01732510|B3|Baseline|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110887|NCT01732510|B2|Baseline|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110888|NCT01732510|B1|Baseline|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110889|NCT01732510|P7|Participant Flow|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110890|NCT01732510|P6|Participant Flow|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110891|NCT01732510|P5|Participant Flow|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
110892|NCT01732510|P4|Participant Flow|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110893|NCT01732510|P3|Participant Flow|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110894|NCT01732510|P2|Participant Flow|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110895|NCT01732510|P1|Participant Flow|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110896|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110897|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110898|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. No participant met criteria for inclusion in the evaluable population.
110899|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110900|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110901|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110902|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110903|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110904|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110905|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110906|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110907|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110908|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110909|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110910|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110911|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110912|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110913|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110914|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110915|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110916|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110917|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110918|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110919|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110920|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110921|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110922|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110923|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110924|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110973|NCT01732484|B1|Baseline|Cataract Surgery|eyes with implantation of iMics1 NY-60 IOL or Acrysof SN60WF IOL
110926|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110927|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110928|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110929|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110930|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110931|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110932|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110933|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110934|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110935|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110936|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110937|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110938|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110939|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110940|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110941|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110942|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110943|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110944|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110945|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110946|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110947|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
110948|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110949|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110950|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110951|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110952|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110953|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110954|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
110955|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110956|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110957|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110958|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110959|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110960|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110961|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
110962|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110963|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110964|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110965|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
110966|NCT01732510|E7|Reported Event|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
110967|NCT01732510|E6|Reported Event|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110968|NCT01732510|E5|Reported Event|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
110969|NCT01732510|E4|Reported Event|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110970|NCT01732510|E3|Reported Event|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110971|NCT01732510|E2|Reported Event|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110972|NCT01732510|E1|Reported Event|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
110974|NCT01732484|P1|Participant Flow|Patients Included|
110975|NCT01732484|O2|Outcome|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
110976|NCT01732484|O1|Outcome|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
110977|NCT01732484|O2|Outcome|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
110978|NCT01732484|O1|Outcome|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
110979|NCT01732484|E2|Reported Event|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
110980|NCT01732484|E1|Reported Event|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
110981|NCT01732471|B1|Baseline|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
110982|NCT01732471|P1|Participant Flow|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 milligram per kilogram per day (mg/kg/day) once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
110983|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
110984|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
110985|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
110986|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
110987|NCT01732471|E1|Reported Event|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
110988|NCT01731990|B3|Baseline|Total|Total of all reporting groups
110989|NCT01731990|B2|Baseline|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
110990|NCT01731990|B1|Baseline|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
110991|NCT01731990|P2|Participant Flow|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
110992|NCT01731990|P1|Participant Flow|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
110993|NCT01731990|O2|Outcome|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
110994|NCT01731990|O1|Outcome|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
110995|NCT01731990|O2|Outcome|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
110996|NCT01731990|O1|Outcome|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
110997|NCT01731990|O2|Outcome|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
110998|NCT01731990|O1|Outcome|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
110999|NCT01731990|O2|Outcome|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
111000|NCT01731990|O1|Outcome|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
111001|NCT01731990|E2|Reported Event|Placebo|Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
111002|NCT01731990|E1|Reported Event|Canakinumab (ACZ885)|Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
111003|NCT01731938|B5|Baseline|Total|Total of all reporting groups
111065|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
113546|NCT01718535|B7|Baseline|*17/*17 CYP2C19 Genotype|
111004|NCT01731938|B4|Baseline|Surgicel® Part II|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
111005|NCT01731938|B3|Baseline|Fibrin Sealant (FS) Grifols Part II|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
111006|NCT01731938|B2|Baseline|Surgicel® Part I|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
111007|NCT01731938|B1|Baseline|Fibrin Sealant (FS) Grifols Part I|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
111008|NCT01731938|P2|Participant Flow|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
111009|NCT01731938|P1|Participant Flow|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
111681|NCT01728792|P4|Participant Flow|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111010|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
111011|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
111012|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
111013|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
111014|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
111015|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Fibrin Sealant (FS) Grifols: Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
111016|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
111017|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
111018|NCT01731938|E2|Reported Event|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
111019|NCT01731938|E1|Reported Event|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
111020|NCT01731470|B1|Baseline|Liposomes|"Liposomes
Liposomes: Intravesical instillation of liposomes."
111021|NCT01731470|P1|Participant Flow|Liposomes|"Liposomes
Liposomes: Intravesical instillation of liposomes."
111022|NCT01731470|O1|Outcome|Liposomes|"Liposomes
Liposomes: Intravesical instillation of liposomes."
111023|NCT01731470|O1|Outcome|Liposomes|"Liposomes
Liposomes: Intravesical instillation of liposomes."
111024|NCT01731470|E1|Reported Event|Liposomes|"Liposomes
Liposomes: Intravesical instillation of liposomes."
111025|NCT01731119|B1|Baseline|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
111026|NCT01731119|P1|Participant Flow|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
111027|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
111028|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
111043|NCT01731041|E1|Reported Event|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
111029|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
111030|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
111031|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
111032|NCT01731119|E1|Reported Event|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
111033|NCT01731041|B3|Baseline|Total|Total of all reporting groups
111034|NCT01731041|B2|Baseline|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
111035|NCT01731041|B1|Baseline|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
111036|NCT01731041|P2|Participant Flow|Ticagrelor 90mg|A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
111037|NCT01731041|P1|Participant Flow|Ticagrelor 180mg|A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
111038|NCT01731041|O2|Outcome|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
111039|NCT01731041|O1|Outcome|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
111040|NCT01731041|O2|Outcome|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
111041|NCT01731041|O1|Outcome|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
111042|NCT01731041|E2|Reported Event|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
111044|NCT01730378|B3|Baseline|Total|Total of all reporting groups
112099|NCT01727258|E1|Reported Event|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
111045|NCT01730378|B2|Baseline|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
111046|NCT01730378|B1|Baseline|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111047|NCT01730378|P2|Participant Flow|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
111048|NCT01730378|P1|Participant Flow|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111049|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
111050|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111051|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111052|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
111053|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111054|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
111055|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111056|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
111057|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111058|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
111059|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111060|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
111061|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111062|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
111063|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
111064|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
112335|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
111066|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111067|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111068|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111069|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111070|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111071|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111072|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111073|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111074|NCT01730378|E2|Reported Event|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
112154|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
111075|NCT01730378|E1|Reported Event|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
111076|NCT01730339|B3|Baseline|Total|Total of all reporting groups
111077|NCT01730339|B2|Baseline|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
111078|NCT01730339|B1|Baseline|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
111079|NCT01730339|P2|Participant Flow|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
111080|NCT01730339|P1|Participant Flow|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
111081|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
111082|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
111083|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
111084|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
111085|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
111086|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
111087|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
111088|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
111502|NCT01729728|O2|Outcome|Protein Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111089|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
111090|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm, (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
111091|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
111092|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
111093|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
111094|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
111095|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
111096|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
111097|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
112155|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
111098|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
111099|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
111100|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
111101|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
111102|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
111103|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, also received 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
111104|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
111105|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast
111106|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
111107|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
111108|NCT01730339|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
111109|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
111110|NCT01730339|O1|Outcome|Group 1: PF-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
111111|NCT01730339|E2|Reported Event|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
111112|NCT01730339|E1|Reported Event|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
111113|NCT01730053|B7|Baseline|Total|Total of all reporting groups
111114|NCT01730053|B6|Baseline|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111115|NCT01730053|B5|Baseline|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111116|NCT01730053|B4|Baseline|Rosuvastatin 40 mg|.Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111117|NCT01730053|B3|Baseline|Alirocumab 75/up to 150 + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111118|NCT01730053|B2|Baseline|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111119|NCT01730053|B1|Baseline|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablet orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111120|NCT01730053|P6|Participant Flow|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
112156|NCT01727141|O4|Outcome|Placebo|b.i.d
111121|NCT01730053|P5|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111122|NCT01730053|P4|Participant Flow|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111123|NCT01730053|P3|Participant Flow|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111124|NCT01730053|P2|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111125|NCT01730053|P1|Participant Flow|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablet orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111126|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111127|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111128|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111129|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111130|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111131|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111503|NCT01729728|O1|Outcome|Protein Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111132|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111133|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111134|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111135|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111136|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111137|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111155|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111138|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111139|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111140|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111141|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111142|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111143|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111144|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111145|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111146|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111147|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111504|NCT01729728|O3|Outcome|LDH Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111148|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111149|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111150|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111151|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111152|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111153|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111154|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111476|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
112157|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
111156|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111157|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111158|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111159|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111160|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
111161|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111162|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111163|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111164|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111165|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
113547|NCT01718535|B6|Baseline|*1/*17 CYP2C19 Genotype|
111166|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111167|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111168|NCT01730053|O6|Outcome|Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111169|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111170|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111171|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111172|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111173|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111174|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111175|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111176|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111177|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111178|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111179|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111180|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111181|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
111182|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111183|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111184|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111185|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111186|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111187|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111188|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111189|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111190|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111191|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111192|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111193|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111194|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111195|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111196|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111197|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111198|NCT01730053|O6|Outcome|Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111199|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111200|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111217|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
112384|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
111201|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111202|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111203|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111204|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111205|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111206|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111207|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111208|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111477|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
111209|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111210|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111211|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111212|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111213|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111214|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111215|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111216|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111505|NCT01729728|O2|Outcome|LDH Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
112385|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
111218|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111219|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111220|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111221|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111222|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111223|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111224|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111225|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111478|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
111226|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111227|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111228|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111229|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111230|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111231|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111232|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111233|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111234|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
113548|NCT01718535|B5|Baseline|*3/*3 CYP2C19 Genotype|
111235|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111236|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111237|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111238|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111239|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111240|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111241|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111242|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111260|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
112158|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
111243|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111244|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111245|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111246|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111247|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111248|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111249|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111250|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111251|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111252|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111253|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111254|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111255|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111256|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111257|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111258|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111259|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111479|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
111261|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111262|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111263|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111264|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111265|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
111266|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
111267|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111268|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111269|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
111270|NCT01730053|E6|Reported Event|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111271|NCT01730053|E5|Reported Event|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
111272|NCT01730053|E4|Reported Event|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
111273|NCT01730053|E3|Reported Event|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111274|NCT01730053|E2|Reported Event|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
111275|NCT01730053|E1|Reported Event|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
111276|NCT01730040|B8|Baseline|Total|Total of all reporting groups
111277|NCT01730040|B7|Baseline|Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111278|NCT01730040|B6|Baseline|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111279|NCT01730040|B5|Baseline|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111280|NCT01730040|B4|Baseline|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111281|NCT01730040|B3|Baseline|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111282|NCT01730040|B2|Baseline|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111283|NCT01730040|B1|Baseline|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111284|NCT01730040|P7|Participant Flow|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111285|NCT01730040|P6|Participant Flow|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111286|NCT01730040|P5|Participant Flow|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111287|NCT01730040|P4|Participant Flow|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111288|NCT01730040|P3|Participant Flow|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111506|NCT01729728|O1|Outcome|LDH Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111289|NCT01730040|P2|Participant Flow|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111290|NCT01730040|P1|Participant Flow|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111291|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111292|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111293|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111294|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111295|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111296|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111297|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111480|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
111298|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111299|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111300|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111301|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111302|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111303|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111304|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111305|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111306|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111307|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111308|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111309|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111310|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111311|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111312|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111313|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111314|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111481|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
113710|NCT01717989|O4|Outcome|September 2011|
111315|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111316|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111317|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111318|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111319|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111320|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111321|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111322|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111507|NCT01729728|O3|Outcome|Bilirubin Concentration: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111323|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111324|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111325|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111326|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111327|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111328|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111329|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111330|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111331|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111482|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
112315|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
111332|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111333|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111334|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111335|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111336|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111337|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111338|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111356|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111339|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111340|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111341|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111342|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111343|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111344|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111345|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111346|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111347|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111348|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111483|NCT01729871|E2|Reported Event|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
111349|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111350|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111351|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111352|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111353|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111354|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111355|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111357|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111358|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111359|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111360|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111361|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111362|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111363|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111364|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111365|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111484|NCT01729871|E1|Reported Event|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
111485|NCT01729728|B4|Baseline|Total|Total of all reporting groups
111366|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111367|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111368|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111369|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111370|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111371|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111372|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111373|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111374|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111375|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111376|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111377|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111378|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111379|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111380|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111381|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111382|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111486|NCT01729728|B3|Baseline|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111383|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111384|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111385|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111386|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111387|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111388|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111389|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111390|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111391|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111392|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111393|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111394|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111395|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111396|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111397|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111398|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111399|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111434|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111659|NCT01729247|O1|Outcome|Low Airway Inflammation|As categorized by physician assessment
113711|NCT01717989|O3|Outcome|June 2011|
111400|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111401|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111402|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111403|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111404|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111405|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111406|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111501|NCT01729728|O3|Outcome|Protein Concentration: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
112386|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
111407|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111408|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111409|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111410|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111411|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111412|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111413|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111414|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111415|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111416|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111473|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
111417|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111418|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111419|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111420|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111421|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111422|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111423|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111424|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111425|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111426|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111427|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111428|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111429|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111430|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111431|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111432|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111433|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111474|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
112359|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
111435|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111436|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111437|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111438|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111439|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111440|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111441|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111442|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111443|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111444|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111445|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111446|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111447|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111448|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111449|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111450|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111451|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111475|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
111452|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111453|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111454|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111455|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111456|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111457|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111458|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111459|NCT01730040|E7|Reported Event|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111460|NCT01730040|E6|Reported Event|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection.Q2W added to stable LMT for 24 weeks.
111461|NCT01730040|E5|Reported Event|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111462|NCT01730040|E4|Reported Event|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
111463|NCT01730040|E3|Reported Event|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up¬-titrated to 150 mg Q2W from Week 12 when LDL-¬C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
111464|NCT01730040|E2|Reported Event|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
111465|NCT01730040|E1|Reported Event|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
111466|NCT01729871|B3|Baseline|Total|Total of all reporting groups
111467|NCT01729871|B2|Baseline|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
111468|NCT01729871|B1|Baseline|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
111469|NCT01729871|P2|Participant Flow|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
111470|NCT01729871|P1|Participant Flow|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
111471|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
111472|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
111660|NCT01729247|O2|Outcome|No ICS Use|Participants that did not use inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)
111487|NCT01729728|B2|Baseline|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111488|NCT01729728|B1|Baseline|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111489|NCT01729728|P3|Participant Flow|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight)
111490|NCT01729728|P2|Participant Flow|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)
111491|NCT01729728|P1|Participant Flow|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight)
111492|NCT01729728|O3|Outcome|TL Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111493|NCT01729728|O2|Outcome|TL Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111494|NCT01729728|O1|Outcome|TL Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111495|NCT01729728|O3|Outcome|ALP Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111496|NCT01729728|O2|Outcome|ALP Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111497|NCT01729728|O1|Outcome|ALP Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111498|NCT01729728|O3|Outcome|CK Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111499|NCT01729728|O2|Outcome|CK Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111500|NCT01729728|O1|Outcome|CK Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111508|NCT01729728|O2|Outcome|Bilirubin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111509|NCT01729728|O1|Outcome|Bilirubin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111510|NCT01729728|O3|Outcome|GGT Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111511|NCT01729728|O2|Outcome|GGT Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111512|NCT01729728|O1|Outcome|GGT Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111513|NCT01729728|O3|Outcome|ALT Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111514|NCT01729728|O2|Outcome|ALT Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111515|NCT01729728|O1|Outcome|ALT Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111516|NCT01729728|O3|Outcome|Urine pH: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111517|NCT01729728|O2|Outcome|Urine pH: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111518|NCT01729728|O1|Outcome|Urine pH: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111519|NCT01729728|O3|Outcome|Specific Gravity Urine: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111520|NCT01729728|O2|Outcome|Specific Gravity Urine: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
113712|NCT01717989|O2|Outcome|March 2011|
111521|NCT01729728|O1|Outcome|Specific Gravity Urine: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111522|NCT01729728|O3|Outcome|Glomerular Filtration Rate: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111523|NCT01729728|O2|Outcome|Glomerular Filtration Rate: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111524|NCT01729728|O1|Outcome|Glomerular Filtration Rate: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111525|NCT01729728|O3|Outcome|Urate: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111526|NCT01729728|O2|Outcome|Urate: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111527|NCT01729728|O1|Outcome|Urate: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111528|NCT01729728|O3|Outcome|Albumin Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111529|NCT01729728|O2|Outcome|Albumin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111530|NCT01729728|O1|Outcome|Albumin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111531|NCT01729728|O3|Outcome|Triglycerides Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111532|NCT01729728|O2|Outcome|Triglycerides Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111533|NCT01729728|O1|Outcome|Triglycerides Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111534|NCT01729728|O3|Outcome|AST Activity: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111535|NCT01729728|O2|Outcome|AST Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111536|NCT01729728|O1|Outcome|AST Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111537|NCT01729728|O3|Outcome|Creatinine Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111538|NCT01729728|O2|Outcome|Creatinine Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111539|NCT01729728|O1|Outcome|Creatinine Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111540|NCT01729728|O3|Outcome|BUN Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
113549|NCT01718535|B4|Baseline|*1/*3 CYP2C19 Genotype|
111541|NCT01729728|O2|Outcome|BUN Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111542|NCT01729728|O1|Outcome|BUN Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111543|NCT01729728|O3|Outcome|Blood Phosphate Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111544|NCT01729728|O2|Outcome|Blood Phosphate Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111545|NCT01729728|O1|Outcome|Blood Phosphate Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111546|NCT01729728|O3|Outcome|Blood Chloride Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111547|NCT01729728|O2|Outcome|Blood Chloride Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111548|NCT01729728|O1|Outcome|Blood Chloride Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111549|NCT01729728|O3|Outcome|Blood Calcium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111550|NCT01729728|O2|Outcome|Blood Calcium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111551|NCT01729728|O1|Outcome|Blood Calcium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111552|NCT01729728|O3|Outcome|Blood Potassium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111553|NCT01729728|O2|Outcome|Blood Potassium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111554|NCT01729728|O1|Outcome|Blood Potassium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111555|NCT01729728|O3|Outcome|Blood Sodium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111556|NCT01729728|O2|Outcome|Blood Sodium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111557|NCT01729728|O1|Outcome|Blood Sodium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111558|NCT01729728|O3|Outcome|Blood Glucose Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111559|NCT01729728|O2|Outcome|Blood Glucose Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111560|NCT01729728|O1|Outcome|Blood Glucose Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111561|NCT01729728|O3|Outcome|Leukocyte Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111562|NCT01729728|O2|Outcome|Leukocyte Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111563|NCT01729728|O1|Outcome|Leukocyte Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111564|NCT01729728|O3|Outcome|Platelet Count: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111565|NCT01729728|O2|Outcome|Platelet Count: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111566|NCT01729728|O1|Outcome|Platelet Count: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111567|NCT01729728|O3|Outcome|Mean Corpuscular Volume: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111568|NCT01729728|O2|Outcome|Mean Corpuscular Volume: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111569|NCT01729728|O1|Outcome|Mean Corpuscular Volume: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111570|NCT01729728|O3|Outcome|Hematocrit: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111571|NCT01729728|O2|Outcome|Hematocrit: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111572|NCT01729728|O1|Outcome|Hematocrit: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111606|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Younger Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.
111573|NCT01729728|O3|Outcome|Hemoglobin Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111574|NCT01729728|O2|Outcome|Hemoglobin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111575|NCT01729728|O1|Outcome|Hemoglobin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111576|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Tmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111577|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Cmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111578|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: AUC|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111579|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: Tmax|Tapentadol oral solution single dose (1mg/kg body weight) of participants aged 12 years to less than 18 years old.
111580|NCT01729728|O3|Outcome|Young and Very Young Children With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111581|NCT01729728|O2|Outcome|Older Children With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111582|NCT01729728|O1|Outcome|Adolescents With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111583|NCT01729728|O3|Outcome|Number of TEAEs: Young and Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 6 years of age.
111584|NCT01729728|O2|Outcome|Number of TEAEs: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
111585|NCT01729728|O1|Outcome|Number of TEAEs: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
111586|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: Cmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
113713|NCT01717989|O1|Outcome|December 2010|
111587|NCT01729728|O3|Outcome|ECG Heart Rate Change: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111588|NCT01729728|O2|Outcome|ECG Heart Rate Change: Older Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111589|NCT01729728|O1|Outcome|ECG Heart Rate Change: Adolescents|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111590|NCT01729728|O3|Outcome|ECG Changes: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111591|NCT01729728|O2|Outcome|ECG Changes: Older Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111592|NCT01729728|O1|Outcome|ECG Changes: Adolescents|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111593|NCT01729728|O3|Outcome|Blood Pressure: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111594|NCT01729728|O2|Outcome|Blood Pressure: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111595|NCT01729728|O1|Outcome|Blood Pressure: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111596|NCT01729728|O3|Outcome|Oxygen Saturation: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111597|NCT01729728|O2|Outcome|Oxygen Saturation: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111598|NCT01729728|O1|Outcome|Oxygen Saturation: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111599|NCT01729728|O3|Outcome|Respiratory Rates: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111600|NCT01729728|O2|Outcome|Respiratory Rates: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111601|NCT01729728|O1|Outcome|Respiratory Rates: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111602|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: AUC|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111603|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Concentrations: Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.
111604|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.
111605|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations Younger Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.
111607|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
111608|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
111609|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
111610|NCT01729728|O1|Outcome|Sum of Pain Intensity Differences|"The sum of pain intensity difference over 4 hours (SPID4) were calculated as the weighted sum of the scheduled pain intensity difference collected up to 4 hours after tapentadol oral solution administration.
The time elapsed (in hours) since the previous measurement is multiplied with the pain intensity difference (PID) at the respective time, and defines the weight in the calculation of the weighted sum of pain intensity differences."
111611|NCT01729728|O1|Outcome|Face, Legs, Activity, Cry, Consolability Scale|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111612|NCT01729728|O2|Outcome|Faces Pain Scale: Young Children|Single Dose of Tapentadol Oral Solution in Children Age 3 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight). The children aged 2 were assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) Scale and not the 6-point Faces Pain Scale - Revised.
111613|NCT01729728|O1|Outcome|Faces Pain Scale: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)
111614|NCT01729728|O2|Outcome|McGrath Color Analog Scale: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111615|NCT01729728|O1|Outcome|McGrath Color Analog Scale: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111616|NCT01729728|O1|Outcome|Visual Analog Scale: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111617|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
111618|NCT01729728|E3|Reported Event|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111619|NCT01729728|E2|Reported Event|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111620|NCT01729728|E1|Reported Event|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
111621|NCT01729559|B3|Baseline|Total|Total of all reporting groups
111622|NCT01729559|B2|Baseline|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
111623|NCT01729559|B1|Baseline|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
111624|NCT01729559|P2|Participant Flow|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
111625|NCT01729559|P1|Participant Flow|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
111626|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
111627|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
111628|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
111629|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
111630|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
111631|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
111632|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
111633|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
111634|NCT01729559|E2|Reported Event|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
111635|NCT01729559|E1|Reported Event|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
111636|NCT01729338|B1|Baseline|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111637|NCT01729338|P1|Participant Flow|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111638|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111639|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111640|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111641|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111701|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111702|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
112387|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
111642|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111643|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111644|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111661|NCT01729247|O1|Outcome|ICS Use|Participants that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)
111662|NCT01729247|O2|Outcome|High ACT Score|Participants who had an asthma control test (ACT) score of >19, which indicates well-controlled asthma
111663|NCT01729247|O1|Outcome|Low ACT Score|Participants who had an asthma control test (ACT) score of <=19, which indicates less well-controlled asthma
113714|NCT01717989|O5|Outcome|December 2011|
111645|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111646|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111647|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111648|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111649|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111650|NCT01729338|E1|Reported Event|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):
VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
111651|NCT01729247|B1|Baseline|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
111652|NCT01729247|P1|Participant Flow|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
111653|NCT01729247|O1|Outcome|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
111654|NCT01729247|O3|Outcome|High Airway Inflammation|As categorized by physician assessment
111655|NCT01729247|O2|Outcome|Intermediate Airway Inflammation|As categorized by physician assessment
111656|NCT01729247|O1|Outcome|Low Airway Inflammation|As categorized by physician assessment
111657|NCT01729247|O3|Outcome|High Airway Inflammation|As categorized by physician assessment
111658|NCT01729247|O2|Outcome|Intermediate Airway Inflammation|As categorized by physician assessment
111664|NCT01729247|E1|Reported Event|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
111665|NCT01729026|B3|Baseline|Total|Total of all reporting groups
111666|NCT01729026|B2|Baseline|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
111667|NCT01729026|B1|Baseline|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
111668|NCT01729026|P2|Participant Flow|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
111669|NCT01729026|P1|Participant Flow|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
111703|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
111704|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
111705|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111670|NCT01729026|O2|Outcome|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
111671|NCT01729026|O1|Outcome|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
111672|NCT01729026|E2|Reported Event|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
111673|NCT01729026|E1|Reported Event|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
111674|NCT01728792|B6|Baseline|Total|Total of all reporting groups
111675|NCT01728792|B5|Baseline|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111676|NCT01728792|B4|Baseline|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111677|NCT01728792|B3|Baseline|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
111678|NCT01728792|B2|Baseline|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
111679|NCT01728792|B1|Baseline|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
111680|NCT01728792|P5|Participant Flow|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111682|NCT01728792|P3|Participant Flow|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
111683|NCT01728792|P2|Participant Flow|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
111684|NCT01728792|P1|Participant Flow|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
111685|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111686|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111687|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
111688|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
111689|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
111690|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111691|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111692|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
111693|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
111694|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
111695|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111696|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111697|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
111698|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
111699|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
111700|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111706|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111707|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
111708|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
111709|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
111710|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111711|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111712|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
111713|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
111714|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
111715|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111716|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111717|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
111718|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
111719|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
111720|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111721|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111722|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
111723|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
111724|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
111725|NCT01728792|E5|Reported Event|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111726|NCT01728792|E4|Reported Event|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
111727|NCT01728792|E3|Reported Event|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
111728|NCT01728792|E2|Reported Event|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
111729|NCT01728792|E1|Reported Event|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
111730|NCT01728584|B5|Baseline|Total|Total of all reporting groups
111731|NCT01728584|B4|Baseline|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
111732|NCT01728584|B3|Baseline|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
111733|NCT01728584|B2|Baseline|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
111734|NCT01728584|B1|Baseline|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
111735|NCT01728584|P4|Participant Flow|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
111736|NCT01728584|P3|Participant Flow|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 Post Tetanic Counts [PTCs])/Standard insufflation pressure (starting pressure of 12 mmHg).
111737|NCT01728584|P2|Participant Flow|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
111738|NCT01728584|P1|Participant Flow|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard (Std) NMB (depth of blockade at a targeted Train of Four [TOF] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
111739|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
111740|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
111741|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
111742|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
113550|NCT01718535|B3|Baseline|*2/*2 CYP2C19 Genotype|
111743|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
111744|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
111745|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
111746|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
111747|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
111748|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
111749|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
111750|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
111751|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
111752|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
111753|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
111754|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
111755|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
111756|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
111757|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
111758|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
111759|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
111760|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
111761|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
111762|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
111763|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
111764|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
111765|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
111766|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
111767|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
111768|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
111769|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
111770|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
111771|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
111772|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
111773|NCT01728584|O4|Outcome|Low Insufflation Pressure|Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
111774|NCT01728584|O3|Outcome|Standard Insufflation Pressure|Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.
111775|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
111776|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
111777|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
111778|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
111779|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
111780|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
112159|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
111781|NCT01728584|O4|Outcome|Low Insufflation Pressure|Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
111782|NCT01728584|O3|Outcome|Standard Insufflation Pressure|Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.
111783|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
111784|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
111785|NCT01728584|E4|Reported Event|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
111786|NCT01728584|E3|Reported Event|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
111787|NCT01728584|E2|Reported Event|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
111788|NCT01728584|E1|Reported Event|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
111789|NCT01728376|B7|Baseline|Total|Total of all reporting groups
111790|NCT01728376|B6|Baseline|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111791|NCT01728376|B5|Baseline|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111792|NCT01728376|B4|Baseline|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111793|NCT01728376|B3|Baseline|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
112388|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
111794|NCT01728376|B2|Baseline|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111795|NCT01728376|B1|Baseline|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111796|NCT01728376|P6|Participant Flow|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111797|NCT01728376|P5|Participant Flow|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111798|NCT01728376|P4|Participant Flow|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111799|NCT01728376|P3|Participant Flow|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111800|NCT01728376|P2|Participant Flow|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111989|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111801|NCT01728376|P1|Participant Flow|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111802|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111803|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111804|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111805|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111806|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111807|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111808|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111809|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111892|NCT01728324|E2|Reported Event|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
111810|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111811|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111812|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111813|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111814|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111815|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111816|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111817|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
112160|NCT01727141|O4|Outcome|Placebo|b.i.d
111818|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111819|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111820|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111821|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111822|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111823|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111824|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111825|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111826|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111827|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111828|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111829|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111830|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111831|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111832|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111833|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111834|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
112161|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
111835|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111836|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111837|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111838|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111839|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111840|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111841|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111842|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111843|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111844|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111845|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111846|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111847|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111848|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111849|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111850|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111851|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
112162|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
111852|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111853|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111854|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111855|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111856|NCT01728376|E6|Reported Event|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111857|NCT01728376|E5|Reported Event|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111858|NCT01728376|E4|Reported Event|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111859|NCT01728376|E3|Reported Event|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111860|NCT01728376|E2|Reported Event|Comparator - 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
111861|NCT01728376|E1|Reported Event|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
111862|NCT01728337|B1|Baseline|Xeomin and Dysport|Xeomin® was injected on the one side of the forehead and Dysport® was injected on the other side of the forehead.
111863|NCT01728337|P1|Participant Flow|Dysport and Xeomin|Dysport® was injected on the one side of the forehead and Xeomin® was injected on the other side of the forehead.
111864|NCT01728337|O2|Outcome|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
111865|NCT01728337|O1|Outcome|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
111866|NCT01728337|O2|Outcome|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
111867|NCT01728337|O1|Outcome|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
111868|NCT01728337|E2|Reported Event|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
111869|NCT01728337|E1|Reported Event|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
111870|NCT01728324|B4|Baseline|Total|Total of all reporting groups
111871|NCT01728324|B3|Baseline|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
111872|NCT01728324|B2|Baseline|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
111873|NCT01728324|B1|Baseline|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
111874|NCT01728324|P3|Participant Flow|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
111875|NCT01728324|P2|Participant Flow|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
111876|NCT01728324|P1|Participant Flow|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
113588|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
111877|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
111878|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
111879|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
111880|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
111881|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
111882|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
111883|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
111884|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
111885|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
111886|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
111887|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
111888|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
111889|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group|This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients
111890|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.
111891|NCT01728324|E3|Reported Event|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
112389|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
111893|NCT01728324|E1|Reported Event|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
111894|NCT01728246|B3|Baseline|Total|Total of all reporting groups
111895|NCT01728246|B2|Baseline|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
111896|NCT01728246|B1|Baseline|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
111897|NCT01728246|P2|Participant Flow|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
111898|NCT01728246|P1|Participant Flow|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
111899|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
111900|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
111901|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
111902|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
111903|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
111904|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
111905|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
111906|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
111907|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
111908|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
111909|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
113589|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
111910|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
111911|NCT01728246|E2|Reported Event|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
111912|NCT01728246|E1|Reported Event|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
111913|NCT01728116|B3|Baseline|Total|Total of all reporting groups
111914|NCT01728116|B2|Baseline|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
111915|NCT01728116|B1|Baseline|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
111916|NCT01728116|P2|Participant Flow|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52.
111917|NCT01728116|P1|Participant Flow|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52 for both groups, and additionally at Week 65 for the EndoBarrier group.
111918|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
111919|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
111920|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
111921|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
111922|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
111923|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
111924|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
111925|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
111926|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
111927|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
111928|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
111929|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
111930|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
111931|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
111932|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
111933|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
111934|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
111935|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
111936|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
111937|NCT01728116|E2|Reported Event|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
111938|NCT01728116|E1|Reported Event|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
111939|NCT01728077|B3|Baseline|Total Title|
111940|NCT01728077|B2|Baseline|Brivaracetam Generalized Epilepsy|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.
111941|NCT01728077|B1|Baseline|Brivaracetam Focal Epilepsy|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.
111942|NCT01728077|P2|Participant Flow|Brivaracetam Generalized Epilepsy|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.
111943|NCT01728077|P1|Participant Flow|Brivaracetam Focal Epilepsy|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.
111944|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (EAS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Efficacy Analysis Set (EAS).
111945|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (EAS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Efficacy Analysis Set (EAS).
111946|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (EAS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Efficacy Analysis Set (EAS).
111970|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111947|NCT01728077|O2|Outcome|Brivaracetam Generalized Epilepsy (SS)|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
111948|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (SS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
111949|NCT01728077|O2|Outcome|Brivaracetam Generalized Epilepsy (SS)|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
111950|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (SS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
111951|NCT01728077|O2|Outcome|Brivaracetam Generalized Epilepsy (SS)|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
111952|NCT01728077|O1|Outcome|Brivaracetam Focal Epilepsy (SS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
111990|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111991|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
113715|NCT01717989|O4|Outcome|September 2011|
111953|NCT01728077|E2|Reported Event|Brivaracetam Generalized Epilepsy (SS)|This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
111954|NCT01728077|E1|Reported Event|Brivaracetam Focal Epilepsy (SS)|This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
111955|NCT01727895|B3|Baseline|Total|Total of all reporting groups
111956|NCT01727895|B2|Baseline|Control Group|No intervention
111957|NCT01727895|B1|Baseline|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.
Beta-glucan (Glucan #300®)"
111958|NCT01727895|P2|Participant Flow|Control Group|No intervention
111959|NCT01727895|P1|Participant Flow|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.
Beta-glucan (Glucan #300®)"
111960|NCT01727895|O2|Outcome|Control Group|No intervention
111961|NCT01727895|O1|Outcome|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.
Beta-glucan (Glucan #300®)"
111962|NCT01727895|E2|Reported Event|Control Group|No intervention
111963|NCT01727895|E1|Reported Event|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.
Beta-glucan (Glucan #300®)"
111964|NCT01727791|B1|Baseline|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111965|NCT01727791|P1|Participant Flow|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111966|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111967|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111968|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111969|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
112390|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
111971|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111972|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111973|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111974|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111975|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111976|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111977|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111978|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111979|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111980|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111981|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111982|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111983|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111984|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111985|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111986|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111987|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111988|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111992|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111993|NCT01727791|E1|Reported Event|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
111994|NCT01727713|B1|Baseline|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
111995|NCT01727713|P1|Participant Flow|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
111996|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
111997|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
111998|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
111999|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112000|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112001|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112002|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112003|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112004|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112005|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112391|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
112006|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112007|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112008|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112009|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112010|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112011|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112012|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112013|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112014|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112015|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112016|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112017|NCT01727713|E1|Reported Event|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
112018|NCT01727700|B4|Baseline|Total|Total of all reporting groups
112019|NCT01727700|B3|Baseline|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
113716|NCT01717989|O3|Outcome|June 2011|
112020|NCT01727700|B2|Baseline|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112021|NCT01727700|B1|Baseline|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112022|NCT01727700|P3|Participant Flow|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
112023|NCT01727700|P2|Participant Flow|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112024|NCT01727700|P1|Participant Flow|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112025|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
112026|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112027|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112028|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
112047|NCT01727505|P2|Participant Flow|Sequence B: Volume Guarantee-Conventional|"This is a crossover study. Each patient is randomly assigned to one of two sequences.
Sequence B consisted of a 24-hour period during which the infant received volume guarantee ventilation followed by a 24 hour period during which the infant received conventional mechanical ventilation."
112029|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112030|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112031|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
112032|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112033|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112034|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
112035|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112036|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112037|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
112038|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112097|NCT01727258|E3|Reported Event|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
113717|NCT01717989|O2|Outcome|March 2011|
112039|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112040|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
112041|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112042|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112043|NCT01727700|E3|Reported Event|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
112044|NCT01727700|E2|Reported Event|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112045|NCT01727700|E1|Reported Event|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
112046|NCT01727505|B1|Baseline|Study Population|"This is a crossover study. Infants were randomly assigned to one of two sequences.
Sequence A consisted of 24 hours of Conventional Mechanical Ventilation followed by 24 hours of Volume Guarantee Ventilation.
Sequence B consisted of 24 hours of Volume Guarantee Ventilation followed by 24 hours of Conventional Mechanical Ventilation."
112112|NCT01727167|O1|Outcome|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.
Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
112048|NCT01727505|P1|Participant Flow|Sequence A: Conventional-Volume Guarantee|"This is a crossover study. Each patient is randomly assigned to one of two sequences.
Sequence A consisted of a 24-hour period during which the infant received conventional mechanical ventilation followed by a 24 hour period during which the infant received volume guarantee ventilation."
112049|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112050|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112051|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112052|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112053|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112054|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112055|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112056|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112057|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112098|NCT01727258|E2|Reported Event|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
113590|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
112058|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112059|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112060|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
The sequence of conventional and volume guarantee ventilation were assigned at random."
112061|NCT01727505|E2|Reported Event|Volume Guarantee Ventilation Period|"This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
These data represent the 24 hours of Volume Guarantee Ventilation."
112062|NCT01727505|E1|Reported Event|Conventional Mechanical Ventilation Period|"This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.
These data represent the 24 hours of Conventional Mechanical Ventilation."
112063|NCT01727414|B3|Baseline|Total|Total of all reporting groups
112064|NCT01727414|B2|Baseline|Combined Type|
112065|NCT01727414|B1|Baseline|Inattentive Type|
112066|NCT01727414|P2|Participant Flow|Combined Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.
OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses [children < 25 kg receive 18mg, 27mg, 36mg; children > or = to 25kg get 18mg, 36mg, 54mg]"
112067|NCT01727414|P1|Participant Flow|Inattentive Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.
Placebo: capsule, frequency - each AM, duration - 1 week"
112068|NCT01727414|O2|Outcome|Combined Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.
OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses [children < 25 kg receive 18mg, 27mg, 36mg; children > or = to 25kg get 18mg, 36mg, 54mg]"
112185|NCT01727024|E1|Reported Event|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
112069|NCT01727414|O1|Outcome|Inattentive Type|"Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.
OROS-Methylphenidate: capsule; dosages - 18mg, 27mg, 36mg, 54 mg; frequency - each AM; duration - one week for each dose, with each child receiving 3 doses [children < 25 kg receive 18mg, 27mg, 36mg; children > or = to 25kg get 18mg, 36mg, 54mg]"
112070|NCT01727414|E2|Reported Event|Combined Type|Children meeting DSM-IV criteria for ADHD-combined type.
112071|NCT01727414|E1|Reported Event|Inattentive Type|Children meeting DSM-IV criteria for ADHD-inattentive type.
112072|NCT01727258|B4|Baseline|Total|Total of all reporting groups
112073|NCT01727258|B3|Baseline|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
112074|NCT01727258|B2|Baseline|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
112075|NCT01727258|B1|Baseline|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
112076|NCT01727258|P3|Participant Flow|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
112077|NCT01727258|P2|Participant Flow|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
112078|NCT01727258|P1|Participant Flow|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
112079|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
112080|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
112081|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
112082|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
112083|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
112084|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
112085|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
112086|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
112087|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
112088|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
112089|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
112090|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
112091|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
112092|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
112093|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
112094|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
112095|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
112096|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
113591|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
112100|NCT01727180|B1|Baseline|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
112101|NCT01727180|P1|Participant Flow|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
112102|NCT01727180|O1|Outcome|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
112103|NCT01727180|E1|Reported Event|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
112104|NCT01727167|B3|Baseline|Total|Total of all reporting groups
112105|NCT01727167|B2|Baseline|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.
200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
112106|NCT01727167|B1|Baseline|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.
Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
112107|NCT01727167|P2|Participant Flow|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.
200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
112108|NCT01727167|P1|Participant Flow|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.
Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
112109|NCT01727167|O2|Outcome|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.
200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
112110|NCT01727167|O1|Outcome|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.
Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
112111|NCT01727167|O2|Outcome|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.
200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
112186|NCT01726621|B1|Baseline|Insulin Depedent Diabetics|Subject is current insulin pump user and has CGM experience as determined by the investigator.
112113|NCT01727167|E2|Reported Event|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.
200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
112114|NCT01727167|E1|Reported Event|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.
Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
112115|NCT01727141|B5|Baseline|Total|Total of all reporting groups
112116|NCT01727141|B4|Baseline|Placebo|b.i.d
112117|NCT01727141|B3|Baseline|NVA237|12.5 ug b.i.d.
112118|NCT01727141|B2|Baseline|QAB149|27.5 ug b.i.d.
112119|NCT01727141|B1|Baseline|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112120|NCT01727141|P4|Participant Flow|Placebo|b.i.d
112121|NCT01727141|P3|Participant Flow|NVA237|12.5 ug b.i.d.
112122|NCT01727141|P2|Participant Flow|QAB149|27.5 ug b.i.d.
112123|NCT01727141|P1|Participant Flow|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112124|NCT01727141|O4|Outcome|Placebo|b.i.d
112125|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
112126|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
112127|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112128|NCT01727141|O4|Outcome|Placebo|b.i.d
112129|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
112130|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
112131|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112132|NCT01727141|O4|Outcome|Placebo|b.i.d
112133|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
112134|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
112135|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112136|NCT01727141|O4|Outcome|Placebo|b.i.d
112137|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
112138|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
112139|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112140|NCT01727141|O4|Outcome|Placebo|b.i.d
112141|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
112142|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
112143|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112144|NCT01727141|O4|Outcome|Placebo|b.i.d
112145|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
112146|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
112147|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112148|NCT01727141|O4|Outcome|Placebo|b.i.d
112149|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
112150|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
112151|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112152|NCT01727141|O4|Outcome|Placebo|b.i.d
112153|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
112163|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112164|NCT01727141|O4|Outcome|Placebo|b.i.d
112165|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
112166|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
112167|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112168|NCT01727141|E4|Reported Event|Placebo|b.i.d
112169|NCT01727141|E3|Reported Event|NVA237|12.5 ug b.i.d.
112170|NCT01727141|E2|Reported Event|QAB149|27.5 ug b.i.d.
112171|NCT01727141|E1|Reported Event|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
112172|NCT01727024|B1|Baseline|All Randomized Participants|All participants who were randomized either to sequence 1 or sequence 2
112173|NCT01727024|P2|Participant Flow|Tiotropium Respimat® First, Then Indacaterol Breezhaler®|In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
112174|NCT01727024|P1|Participant Flow|Indacaterol Breezhaler® First, Then Tiotropium Respimat®|In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
112175|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
112176|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
112177|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
112178|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
112179|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
112180|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
112181|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
112182|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
112183|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
112184|NCT01727024|E2|Reported Event|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
112187|NCT01726621|P1|Participant Flow|Insulin Dependent Diabetics|Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter
112188|NCT01726621|O1|Outcome|Insulin Depedent Diabetics|Subject is current insulin pump user and has CGM experience as determined by the investigator.
112189|NCT01726621|E1|Reported Event|Insulin Dependent Diabetics|"Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter
Medtronic MiniMed 620G or 640G Insulin Pump: Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks."
112190|NCT01726517|B6|Baseline|Total|Total of all reporting groups
112191|NCT01726517|B5|Baseline|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
112192|NCT01726517|B4|Baseline|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112193|NCT01726517|B3|Baseline|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112194|NCT01726517|B2|Baseline|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
112195|NCT01726517|B1|Baseline|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
112196|NCT01726517|P5|Participant Flow|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
112197|NCT01726517|P4|Participant Flow|LDV/SOF 12 Weeks (TE)|Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112198|NCT01726517|P3|Participant Flow|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112199|NCT01726517|P2|Participant Flow|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks.
112200|NCT01726517|P1|Participant Flow|LDV/SOF 8 Weeks (TN)|Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks.
112201|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
112202|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112203|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112204|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
112205|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
112206|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
112207|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112208|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112209|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
112210|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
112211|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
112212|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112213|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112214|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
112215|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
112216|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
112217|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112218|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112219|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
112220|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
112221|NCT01726517|E5|Reported Event|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
113551|NCT01718535|B2|Baseline|*1/*2 CYP2C19 Genotype|
112222|NCT01726517|E4|Reported Event|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112223|NCT01726517|E3|Reported Event|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
112224|NCT01726517|E2|Reported Event|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
112225|NCT01726517|E1|Reported Event|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
112226|NCT01726504|B3|Baseline|Total|Total of all reporting groups
112227|NCT01726504|B2|Baseline|Sham Electro-acupuncture|The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.
112228|NCT01726504|B1|Baseline|Electro-acupuncture|"The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.
The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.
Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total."
112229|NCT01726504|P2|Participant Flow|Sham Electro-acupuncture|The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.
112527|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112230|NCT01726504|P1|Participant Flow|Electro-acupuncture|"The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.
The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.
Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total."
112231|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112232|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112283|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
112284|NCT01726049|E2|Reported Event|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
112285|NCT01726049|E1|Reported Event|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
112286|NCT01726023|B3|Baseline|Total|Total of all reporting groups
112287|NCT01726023|B2|Baseline|Meropenem|Meropenem powder for solution for infusion 1000mg
112392|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
112233|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112234|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112235|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112236|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112263|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112264|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112237|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112238|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112239|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112240|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112241|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112242|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112243|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112265|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112266|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112244|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112245|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112246|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112247|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112248|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112249|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112250|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112267|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112268|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112251|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112252|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112253|NCT01726504|E2|Reported Event|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
112254|NCT01726504|E1|Reported Event|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
112255|NCT01726335|B1|Baseline|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112256|NCT01726335|P1|Participant Flow|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112257|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112258|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112259|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112260|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112261|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112262|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112314|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112269|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112270|NCT01726335|E1|Reported Event|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
112271|NCT01726049|B3|Baseline|Total|Total of all reporting groups
112272|NCT01726049|B2|Baseline|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
112273|NCT01726049|B1|Baseline|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
112274|NCT01726049|P2|Participant Flow|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
112275|NCT01726049|P1|Participant Flow|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
112276|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
112277|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
112278|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
112279|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
112280|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
112281|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
112282|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
112288|NCT01726023|B1|Baseline|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112289|NCT01726023|P2|Participant Flow|Meropenem|Meropenem powder for solution for infusion 1000mg
112290|NCT01726023|P1|Participant Flow|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112291|NCT01726023|O6|Outcome|Avibactam(3)|300-360 minutes after
112292|NCT01726023|O5|Outcome|Ceftazidime(3)|300-360 minutes after
112293|NCT01726023|O4|Outcome|Avibactam(2)|30-90 minutes after
112294|NCT01726023|O3|Outcome|Ceftazidime(2)|30-90 minutes after
112295|NCT01726023|O2|Outcome|Avibactam(1)|15 minutes before or after
112296|NCT01726023|O1|Outcome|Ceftazidime(1)|15 minutes before or after
112297|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112298|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112299|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112300|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112301|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112302|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112303|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112304|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112305|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112306|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112307|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112308|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112309|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112310|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112311|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112312|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112313|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
113718|NCT01717989|O1|Outcome|December 2010|
112316|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112317|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112318|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
112319|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112320|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
112321|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112322|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
112323|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112324|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
112325|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112326|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
112327|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112328|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
112329|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112330|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
112331|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112332|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
112333|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112334|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
112336|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112337|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112338|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112339|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112340|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112341|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112342|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112343|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112344|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112345|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112346|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112347|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112348|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112349|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112350|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112351|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112352|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112353|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112354|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112355|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112356|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112357|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112358|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112360|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112361|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112362|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112363|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112364|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112365|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112366|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112367|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112368|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112369|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112370|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112371|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112372|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112373|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112374|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112375|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
112376|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
112377|NCT01726023|E2|Reported Event|Meropenem|Meropenem powder for solution for infusion 1000mg
112378|NCT01726023|E1|Reported Event|CAZ-AVI Plus Metronidazole|
112379|NCT01725984|B3|Baseline|Total|Total of all reporting groups
112380|NCT01725984|B2|Baseline|AdVance XP|Subjects previously implanted with the AdVance XP male sling
112381|NCT01725984|B1|Baseline|AdVance|Subjects previously implanted with the AdVance Male Sling
112382|NCT01725984|P2|Participant Flow|AdVance XP|Subjects previously implanted with the AdVance XP male sling
112383|NCT01725984|P1|Participant Flow|AdVance|Subjects previously implanted with the AdVance Male Sling
112393|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
112394|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
112395|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
112396|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
112397|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
112398|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
112399|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
112400|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
112401|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
112402|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
112403|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
112404|NCT01725984|E2|Reported Event|AdVance XP|Subjects implanted with the AdVance XP Male Sling
112405|NCT01725984|E1|Reported Event|AdVance|Subjects implanted with the AdVance Male Sling
112406|NCT01725529|B4|Baseline|Total|Total of all reporting groups
112407|NCT01725529|B3|Baseline|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112408|NCT01725529|B2|Baseline|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112409|NCT01725529|B1|Baseline|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
113592|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
112410|NCT01725529|P3|Participant Flow|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112411|NCT01725529|P2|Participant Flow|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112412|NCT01725529|P1|Participant Flow|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
112413|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112414|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112415|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
112416|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112417|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112418|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
112419|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112420|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112421|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
112422|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112423|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112424|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
112425|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112426|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112427|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
112428|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112429|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112430|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
113719|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
112431|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112432|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112433|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
112434|NCT01725529|E3|Reported Event|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112435|NCT01725529|E2|Reported Event|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
112436|NCT01725529|E1|Reported Event|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
112437|NCT01725451|B1|Baseline|Testosterone 2% Solution|Participants randomized to 1 of 4 treatment sequences involving 6 treatments in each sequence. Each sequence involved 4 single-dose treatments of testosterone 2% solution to unshaved axillae with or without the use of deodorant or antiperspirant products followed by 2 single-dose treatments of testosterone 2% solution to shaved axillae with or without the use of deodorant or antiperspirant products. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
112438|NCT01725451|P4|Participant Flow|Sequence 4|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
112439|NCT01725451|P3|Participant Flow|Sequence 3|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
112592|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
112440|NCT01725451|P2|Participant Flow|Sequence 2|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
112441|NCT01725451|P1|Participant Flow|Sequence 1|30-milligram (mg) testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
112442|NCT01725451|O6|Outcome|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
112443|NCT01725451|O5|Outcome|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
112444|NCT01725451|O4|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
112445|NCT01725451|O3|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution .
112446|NCT01725451|O2|Outcome|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
113720|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
112447|NCT01725451|O1|Outcome|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
112448|NCT01725451|O6|Outcome|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
112449|NCT01725451|O5|Outcome|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
112450|NCT01725451|O4|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
112451|NCT01725451|O3|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
112452|NCT01725451|O2|Outcome|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
112453|NCT01725451|O1|Outcome|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
112454|NCT01725451|E6|Reported Event|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
112455|NCT01725451|E5|Reported Event|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
112456|NCT01725451|E4|Reported Event|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
112457|NCT01725451|E3|Reported Event|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
112458|NCT01725451|E2|Reported Event|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
112459|NCT01725451|E1|Reported Event|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
112460|NCT01725386|B3|Baseline|Total|Total of all reporting groups
112461|NCT01725386|B2|Baseline|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
112462|NCT01725386|B1|Baseline|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
112463|NCT01725386|P2|Participant Flow|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
112464|NCT01725386|P1|Participant Flow|Monotherapy|Capecitabine (XELODA®) as monotherapy according to prescribing information and normal clinical practice.
112465|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
112466|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
112467|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
112468|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
112593|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
112469|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
112470|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
112471|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
112472|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
112473|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
112474|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
112475|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
112476|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
112477|NCT01725386|E2|Reported Event|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
112478|NCT01725386|E1|Reported Event|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
112479|NCT01725308|B4|Baseline|Total|Total of all reporting groups
112480|NCT01725308|B3|Baseline|Treatment Period I: FK949E 300 mg|Participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112481|NCT01725308|B2|Baseline|Treatment Period I: FK949E 150 mg|Participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112482|NCT01725308|B1|Baseline|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112483|NCT01725308|P3|Participant Flow|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112484|NCT01725308|P2|Participant Flow|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112485|NCT01725308|P1|Participant Flow|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112486|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
113593|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
112487|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112488|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112489|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112490|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112491|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112492|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112493|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112494|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112495|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112496|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112497|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112498|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112499|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112500|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112501|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112502|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112503|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112504|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112505|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112506|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112507|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112508|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112509|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
113552|NCT01718535|B1|Baseline|*1/*1 CYP2C19 Genotype|
112510|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112511|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112512|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112513|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112514|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112515|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112516|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112517|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112518|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112519|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112520|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112521|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112522|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112523|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112524|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112525|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112526|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
113721|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
112528|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112529|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112530|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112531|NCT01725308|E3|Reported Event|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
112532|NCT01725308|E2|Reported Event|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
112533|NCT01725308|E1|Reported Event|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
112534|NCT01725282|B5|Baseline|Total|Total of all reporting groups
112535|NCT01725282|B4|Baseline|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
112536|NCT01725282|B3|Baseline|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
112537|NCT01725282|B2|Baseline|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
112538|NCT01725282|B1|Baseline|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
112539|NCT01725282|P4|Participant Flow|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
112540|NCT01725282|P3|Participant Flow|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
112541|NCT01725282|P2|Participant Flow|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
112542|NCT01725282|P1|Participant Flow|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
112543|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
112544|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
112545|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
112546|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
112547|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
112548|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
113553|NCT01718535|P10|Participant Flow|*3/*17 CYP2C19 Genotype|
112549|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
112550|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
112551|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
112552|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
112553|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
112554|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
112555|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
112556|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
112557|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
112558|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
112559|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
112560|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
112561|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
112562|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
112563|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
112564|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
113594|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
112565|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
112566|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
112567|NCT01725282|E4|Reported Event|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
112568|NCT01725282|E3|Reported Event|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
112569|NCT01725282|E2|Reported Event|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
112570|NCT01725282|E1|Reported Event|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
112571|NCT01725217|B4|Baseline|Total|Total of all reporting groups
112572|NCT01725217|B3|Baseline|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
112573|NCT01725217|B2|Baseline|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
112574|NCT01725217|B1|Baseline|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
112575|NCT01725217|P3|Participant Flow|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
112576|NCT01725217|P2|Participant Flow|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
112577|NCT01725217|P1|Participant Flow|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
112578|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
112579|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
112580|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
112581|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
112582|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
112583|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
112584|NCT01725217|O2|Outcome|≥6 to ≤10 Years|Subjects ≥6 to ≤10 years of age who received one vaccination of MenACWY-CRM
112585|NCT01725217|O1|Outcome|Overall (≥6 Years)|All subjects ≥6 years of age who received one vaccination of MenACWY-CRM
112586|NCT01725217|O2|Outcome|≥2 to ≤3 Years|Subjects ≥2 to ≤3 years of age who received one vaccination of MenACWY-CRM
112587|NCT01725217|O1|Outcome|≥2 to ≤5 Years|Subjects ≥2 to ≤5 years of age who received one vaccination of MenACWY-CRM
112588|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
112589|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
112590|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
112591|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
113554|NCT01718535|P9|Participant Flow|*2/*17 CYP2C19 Genotype|
112594|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
112595|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
112596|NCT01725217|O3|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
112597|NCT01725217|O2|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
112598|NCT01725217|O1|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
112599|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
112600|NCT01725217|E4|Reported Event|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
112601|NCT01725217|E3|Reported Event|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
112602|NCT01725217|E2|Reported Event|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
112603|NCT01725217|E1|Reported Event|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
112604|NCT01724528|B3|Baseline|Total|Total of all reporting groups
112605|NCT01724528|B2|Baseline|Allopurinol|"Allopurinol for 7-9 days
Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
112606|NCT01724528|B1|Baseline|Febuxostat|"Febuxostat for 7-9 days
Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
112607|NCT01724528|P2|Participant Flow|Allopurinol|"Allopurinol for 7-9 days
Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
112608|NCT01724528|P1|Participant Flow|Febuxostat|"Febuxostat for 7-9 days
Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
112609|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days
Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
112610|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days
Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
112644|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
112611|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days
Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
112612|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days
Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
112613|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days
Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
112614|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days
Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
112615|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days
Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
112616|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days
Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
112617|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days
Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
112618|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days
Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
112619|NCT01724528|E2|Reported Event|Allopurinol|"Allopurinol for 7-9 days
Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
112620|NCT01724528|E1|Reported Event|Febuxostat|"Febuxostat for 7-9 days
Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
112621|NCT01724359|B1|Baseline|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112622|NCT01724359|P1|Participant Flow|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112623|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112624|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112625|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112626|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112627|NCT01724359|O2|Outcome|Patients at Week 26: Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
113555|NCT01718535|P8|Participant Flow|*2/*3 CYP2C19 Genotype|
112628|NCT01724359|O1|Outcome|Patients at Baseline: Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112629|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112630|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112631|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112632|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112633|NCT01724359|E1|Reported Event|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
112634|NCT01724216|B1|Baseline|Single Arm|Magnetic Resonance Image Collection Using Innovative Pulse Sequences
112635|NCT01724216|P1|Participant Flow|Single Arm|Magnetic Resonance Images Collected Using Innovative Pulse Sequences :
112636|NCT01724216|O1|Outcome|Single Arm|Magnetic Resonance Imaging Using Innovative Pulse Sequences :
112637|NCT01724216|E1|Reported Event|Single Arm|Magnetic Resonance Imaging Using Innovative Pulse Sequences :
112638|NCT01724177|B1|Baseline|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity.
112639|NCT01724177|P1|Participant Flow|Lenalidomide|Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
112640|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
112641|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
112642|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
112643|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
112645|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
112646|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
112647|NCT01724177|E1|Reported Event|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
112648|NCT01724021|B3|Baseline|Total|Total of all reporting groups
112649|NCT01724021|B2|Baseline|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112650|NCT01724021|B1|Baseline|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112651|NCT01724021|P2|Participant Flow|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112652|NCT01724021|P1|Participant Flow|Arm A|Participants in Arm A received one cycle of rituximab 375 milligram per metre square (mg/m^2) intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112653|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112654|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112744|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
112655|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112656|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112657|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112658|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112659|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112660|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
113595|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
112661|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112662|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112663|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112664|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112665|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112666|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112667|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112776|NCT01723228|B3|Baseline|Total|Total of all reporting groups
113556|NCT01718535|P7|Participant Flow|*17/*17 CYP2C19 Genotype|
112668|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112669|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112670|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112671|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112672|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112673|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112674|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
113596|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
112675|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112676|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112677|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112678|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112679|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112680|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112681|NCT01724021|E2|Reported Event|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112682|NCT01724021|E1|Reported Event|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
112683|NCT01723904|B1|Baseline|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
112684|NCT01723904|P1|Participant Flow|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
112685|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
112686|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
113132|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
112687|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
112688|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
112689|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
112690|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
112691|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
112714|NCT01723254|B6|Baseline|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112692|NCT01723904|E1|Reported Event|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
112693|NCT01723722|B3|Baseline|Total|Total of all reporting groups
112694|NCT01723722|B2|Baseline|DTO After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
112695|NCT01723722|B1|Baseline|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
112696|NCT01723722|P2|Participant Flow|Deodorized Tincture Opium After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
112697|NCT01723722|P1|Participant Flow|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
112698|NCT01723722|O2|Outcome|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
112699|NCT01723722|O1|Outcome|Deodorized Tincture Opium After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
112700|NCT01723722|E2|Reported Event|DTO After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
112701|NCT01723722|E1|Reported Event|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
112702|NCT01723397|B3|Baseline|Total|Total of all reporting groups
112703|NCT01723397|B2|Baseline|Placebo Spray, Then Nasaleze Spray|"This group first received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
112704|NCT01723397|B1|Baseline|Nasaleze Spray, Then Placebo Spray|"This group first received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
112802|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
112705|NCT01723397|P2|Participant Flow|Placebo Spray, Then Nasaleze Spray|"This group first received Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (grass or ragweed) challenge, followed by a 1 week washout and then received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
112706|NCT01723397|P1|Participant Flow|Nasaleze Spray, Then Placebo Spray|"This group first received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
112707|NCT01723397|O2|Outcome|Placebo Spray|"Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge
Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen
Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
112708|NCT01723397|O1|Outcome|Nasaleze Spray|"Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge
Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen
Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
112709|NCT01723397|E2|Reported Event|Placebo Spray|"Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge
Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen
Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
112710|NCT01723397|E1|Reported Event|Nasaleze Spray|"Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge
Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen
Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
112711|NCT01723254|B9|Baseline|Total|Total of all reporting groups
112712|NCT01723254|B8|Baseline|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
112713|NCT01723254|B7|Baseline|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112777|NCT01723228|B2|Baseline|Placebo|Placebo oral tablets once daily for 24 weeks
112778|NCT01723228|B1|Baseline|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
112715|NCT01723254|B5|Baseline|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112716|NCT01723254|B4|Baseline|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112717|NCT01723254|B3|Baseline|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112718|NCT01723254|B2|Baseline|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112719|NCT01723254|B1|Baseline|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112720|NCT01723254|P8|Participant Flow|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
112721|NCT01723254|P7|Participant Flow|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112803|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)"
113344|NCT01720316|O1|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 1|Subject1: Auditory ERPs (amplitude) baseline
112722|NCT01723254|P6|Participant Flow|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112723|NCT01723254|P5|Participant Flow|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112724|NCT01723254|P4|Participant Flow|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112725|NCT01723254|P3|Participant Flow|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112726|NCT01723254|P2|Participant Flow|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112727|NCT01723254|P1|Participant Flow|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112728|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
112779|NCT01723228|P2|Participant Flow|Placebo|Placebo oral tablets once daily for 24 weeks
113557|NCT01718535|P6|Participant Flow|*1/*17 CYP2C19 Genotype|
112729|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112730|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112731|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112732|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112733|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112734|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112735|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112736|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
113133|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
112737|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112738|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112739|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112740|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112741|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112742|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112743|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112745|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112746|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112747|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112748|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112749|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112750|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112751|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112752|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
112753|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112754|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112755|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112756|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112757|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112758|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112759|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112760|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
112761|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112762|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112763|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112764|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112765|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112766|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112767|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
112768|NCT01723254|E8|Reported Event|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
112769|NCT01723254|E7|Reported Event|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112770|NCT01723254|E6|Reported Event|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112771|NCT01723254|E5|Reported Event|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112772|NCT01723254|E4|Reported Event|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112773|NCT01723254|E3|Reported Event|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112774|NCT01723254|E2|Reported Event|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112775|NCT01723254|E1|Reported Event|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
112780|NCT01723228|P1|Participant Flow|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
112781|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
112782|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
112783|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
112784|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
112785|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
112786|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
112787|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
112788|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
112789|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
112790|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
112791|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
112792|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
112793|NCT01723228|E2|Reported Event|Placebo|Placebo oral tablets once daily for 24 weeks
112794|NCT01723228|E1|Reported Event|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
112795|NCT01722994|B3|Baseline|Total|Total of all reporting groups
112796|NCT01722994|B2|Baseline|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
112797|NCT01722994|B1|Baseline|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)"
112798|NCT01722994|P2|Participant Flow|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
112799|NCT01722994|P1|Participant Flow|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)"
112800|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
112801|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)"
112804|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
112805|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)"
112806|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
112807|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)"
112808|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound|"This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
112809|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound|"One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)"
112810|NCT01722994|E2|Reported Event|Group 2 Punch Biopsy Wound|"This is one of two absorbable sutures used to close punch biopsy wounds.
Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
112811|NCT01722994|E1|Reported Event|Group 1 Punch Biopsy Wound|"One of two absorbable sutures is used to close punch wounds.
Chromic Gut Sterile absorbable Suture (Ethicon)"
112812|NCT01722877|B1|Baseline|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery. Patients were eligible for the study only if they had a more or equal 50% in-stent restenotic lesion in the superficial femoral or popliteal arteries (estimated diameter ≥5 mm), Rutherford category 1-5 ischemia, and at least one patent infrapopliteal runoff vessel. Patients were excluded if they were not able to give informed consent, had a creatinine level >2.5 mg/dL, were unable to take antiplatelet drugs, or had a planned surgical or endovascular procedure within 15 days of the index procedure.The JetStream was used as a first modality of treatment, no other debulking devices, cutting/scoring balloons, or cryogenic balloons were allowed.
112813|NCT01722877|P1|Participant Flow|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
112814|NCT01722877|O1|Outcome|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
112815|NCT01722877|O1|Outcome|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
112816|NCT01722877|O1|Outcome|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
113558|NCT01718535|P5|Participant Flow|*3/*3 CYP2C19 Genotype|
112817|NCT01722877|O1|Outcome|JetStream Atherectomy|"Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature.
JetStream Navitus: Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery."
112818|NCT01722877|E1|Reported Event|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
112819|NCT01722734|B4|Baseline|Total|Total of all reporting groups
112820|NCT01722734|B3|Baseline|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
112821|NCT01722734|B2|Baseline|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
112822|NCT01722734|B1|Baseline|Control|Patients in this group received only a generic malaria information message (use bed nets) at the end of the study.
112823|NCT01722734|P3|Participant Flow|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
112824|NCT01722734|P2|Participant Flow|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
112825|NCT01722734|P1|Participant Flow|Control|Control group participants received only a message after five days informing them about the importance of using bed nets for malaria. No reminders to take ACTs were sent.
112826|NCT01722734|O3|Outcome|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
112827|NCT01722734|O2|Outcome|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
112828|NCT01722734|O1|Outcome|Control|Subjects in this group received only one generic malaria message (use bed nets) at the end of the study.
112829|NCT01722734|E3|Reported Event|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
112830|NCT01722734|E2|Reported Event|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
112831|NCT01722734|E1|Reported Event|Control|Patients in this group received only a generic malaria message at the end of the study.
113176|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
112832|NCT01722552|B1|Baseline|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.
adherence feedback"
112833|NCT01722552|P1|Participant Flow|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.
adherence feedback"
112834|NCT01722552|O2|Outcome|Control|Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
112835|NCT01722552|O1|Outcome|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.
adherence feedback"
112836|NCT01722552|O2|Outcome|Control|Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
112837|NCT01722552|O1|Outcome|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.
adherence feedback"
112838|NCT01722552|E2|Reported Event|Control|Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
112873|NCT01722266|B1|Baseline|Placebo|"Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
112839|NCT01722552|E1|Reported Event|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.
adherence feedback"
112840|NCT01722487|B3|Baseline|Total|Total of all reporting groups
112841|NCT01722487|B2|Baseline|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
112842|NCT01722487|B1|Baseline|Ibrutinib|Ibrutinib 420 mg daily.
112843|NCT01722487|P2|Participant Flow|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
112844|NCT01722487|P1|Participant Flow|Ibrutinib|Ibrutinib 420 mg daily.
112845|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
112846|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
112847|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
112848|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
112849|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
112850|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
112851|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
112852|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
112853|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
112854|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
112855|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
112856|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
112857|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
112858|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
112859|NCT01722487|E2|Reported Event|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
112860|NCT01722487|E1|Reported Event|PCI-32765|Ibrutinib 420 mg daily.
112881|NCT01722266|O1|Outcome|Placebo|"Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
112925|NCT01722071|P2|Participant Flow|Oxytocin Then Placebo|"These participants were first studied using fMRI following self-administration of oxytocin (followed by another scanning session with placebo).
Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
112861|NCT01722435|B1|Baseline|OST Completers|"The main objective of this prospective study was the description of the process of termination of opiate substitution treatment (OST). Patients in primary care setting (GPs) or specialized clinics likely to complete OST during the next 12 months were asked to fill out questionnaires every 3 months over a 12-months period and were followed up another 6 months later. Accordingly, the doctors documented their patients’ state of health and provided an evaluation of their living situation every 3 months and at the end of treatment (or – if patients stayed in treatment – at the end of the 18-months study period).
At the beginning of the study overall 1367 OST patients were treated in the 7 participating clinics and practices. 972 of them were treated with methadone or levomethadone. In line with the inclusion criteria, 97 patients were eligible for the study, 78 of them consented to participate in the study (8.0% of all patients treated with methadone or levomethadone)."
112862|NCT01722435|P1|Participant Flow|OST Completers|"Patients who are likely to complete OST during the next 12 or 18 months
Opiate Substitution Treatment"
112863|NCT01722435|O1|Outcome|Still in OST Completers|Patients still in OST during the whole study period.
112864|NCT01722435|O1|Outcome|OST Drop-outs|Patients dropped out of OST during 12 or 18 months.
112865|NCT01722435|O1|Outcome|OST Completers|Patients completed OST during 12 or 18 months.
112866|NCT01722435|O1|Outcome|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months.
112867|NCT01722435|O1|Outcome|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
112868|NCT01722435|E1|Reported Event|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
112869|NCT01722266|B5|Baseline|Total|Total of all reporting groups
112870|NCT01722266|B4|Baseline|Liraglutide 0.6 mg|"Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112871|NCT01722266|B3|Baseline|Liraglutide 1.2mg|"Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112872|NCT01722266|B2|Baseline|Liraglutide 1.8mg|"Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
113044|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113559|NCT01718535|P4|Participant Flow|*1/*3 CYP2C19 Genotype|
112874|NCT01722266|P4|Participant Flow|Liraglutide 0.6 mg|"Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112875|NCT01722266|P3|Participant Flow|Liraglutide 1.2mg|"Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112876|NCT01722266|P2|Participant Flow|Liraglutide 1.8mg|"Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112877|NCT01722266|P1|Participant Flow|Placebo|"Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
112878|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112879|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112880|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112923|NCT01722097|E1|Reported Event|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
Rocuronium"
112924|NCT01722071|B1|Baseline|Participants|Each participant will complete baseline assessments prior to being studied using fMRI
112882|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112883|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112884|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112885|NCT01722266|O1|Outcome|Placebo|"Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
112886|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112887|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112888|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112889|NCT01722266|O1|Outcome|Placebo|"Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
113107|NCT01721161|O1|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113560|NCT01718535|P3|Participant Flow|*2/*2 CYP2C19 Genotype|
112890|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112891|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112892|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112893|NCT01722266|O1|Outcome|Placebo|"Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
112894|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112895|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112896|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112897|NCT01722266|O1|Outcome|Placebo|"Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
113066|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
112898|NCT01722266|E4|Reported Event|Liraglutide 0.6 mg|"Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112899|NCT01722266|E3|Reported Event|Liraglutide 1.2mg|"Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112900|NCT01722266|E2|Reported Event|Liraglutide 1.8mg|"Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
112901|NCT01722266|E1|Reported Event|Placebo|"Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
112902|NCT01722162|B3|Baseline|Total|Total of all reporting groups
112903|NCT01722162|B2|Baseline|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.
Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.
Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
112904|NCT01722162|B1|Baseline|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.
Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.
Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
112905|NCT01722162|P2|Participant Flow|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.
Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.
Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
112906|NCT01722162|P1|Participant Flow|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.
Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.
Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
113045|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
112907|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.
Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.
Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
112908|NCT01722162|O2|Outcome|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.
Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.
Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
112909|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.
Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.
Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
112910|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.
Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.
Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
112911|NCT01722162|E2|Reported Event|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.
Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.
Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
112912|NCT01722162|E1|Reported Event|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.
Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.
Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
112913|NCT01722097|B3|Baseline|Total|Total of all reporting groups
112914|NCT01722097|B2|Baseline|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo"
112915|NCT01722097|B1|Baseline|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
Rocuronium"
112916|NCT01722097|P2|Participant Flow|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo"
112917|NCT01722097|P1|Participant Flow|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
Rocuronium"
112918|NCT01722097|O2|Outcome|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo"
112919|NCT01722097|O1|Outcome|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
Rocuronium"
112920|NCT01722097|O2|Outcome|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo"
112921|NCT01722097|O1|Outcome|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
Rocuronium"
112922|NCT01722097|E2|Reported Event|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo"
112926|NCT01722071|P1|Participant Flow|Placebo Then Oxytocin|"These participants were first studied using fMRI following self-administration of placebo (followed by another scanning session with oxytocin).
Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
112927|NCT01722071|O2|Outcome|Oxytocin Then Placebo|"Each participant will be studied using fMRI following self-administration of oxytocin.
Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
112928|NCT01722071|O1|Outcome|Placebo Then Oxytocin|"Each participant will be studied using fMRI following self-administration of placebo.
Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
112929|NCT01722071|E2|Reported Event|Oxytocin Then Placebo|"Each participant will be studied using fMRI following self-administration of oxytocin.
Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
112930|NCT01722071|E1|Reported Event|Placebo Then Oxytocin|"Each participant will be studied using fMRI following self-administration of placebo.
Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
112931|NCT01721967|B1|Baseline|Ranolazine|Ranolazine, 500 mg for 60 days
112932|NCT01721967|P1|Participant Flow|Ranolazine|Ranolazine, 500 mg for 60 days
112933|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
112934|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
112935|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
112936|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
112937|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
112938|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
112939|NCT01721967|E1|Reported Event|Ranolazine|Ranolazine, 500 mg for 60 days
112940|NCT01721837|B1|Baseline|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
112941|NCT01721837|P1|Participant Flow|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (Per Protocol Set, PPS).
112942|NCT01721837|O1|Outcome|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
112943|NCT01721837|E1|Reported Event|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
112944|NCT01721772|B3|Baseline|Total|Total of all reporting groups
113046|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113108|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
112945|NCT01721772|B2|Baseline|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112946|NCT01721772|B1|Baseline|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112947|NCT01721772|P2|Participant Flow|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112948|NCT01721772|P1|Participant Flow|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112949|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112950|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112951|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112952|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112953|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112954|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112955|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112956|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
113222|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
112957|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112958|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112959|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112960|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112961|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112962|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112963|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112964|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
113104|NCT01721161|B1|Baseline|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113561|NCT01718535|P2|Participant Flow|*1/*2 CYP2C19 Genotype|
112965|NCT01721772|E2|Reported Event|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112966|NCT01721772|E1|Reported Event|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
112967|NCT01721759|B1|Baseline|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
112968|NCT01721759|P1|Participant Flow|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
112969|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
112970|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
112971|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
112972|NCT01721759|E1|Reported Event|NivolumAB, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
112973|NCT01721746|B3|Baseline|Total|Total of all reporting groups
112974|NCT01721746|B2|Baseline|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
112975|NCT01721746|B1|Baseline|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
112976|NCT01721746|P3|Participant Flow|Investigator's Choice (Carboplatin+Paclitaxel)|"Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
112977|NCT01721746|P2|Participant Flow|Investigator's Choice (Dacarbazine)|Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
112978|NCT01721746|P1|Participant Flow|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
112979|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
112980|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
112981|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
112982|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
112983|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
112984|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
113105|NCT01721161|P2|Participant Flow|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
112985|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
112986|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
112987|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
112988|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
112989|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
112990|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
112991|NCT01721746|E2|Reported Event|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
112992|NCT01721746|E1|Reported Event|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
112993|NCT01721564|B1|Baseline|Bosentan|62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
112994|NCT01721564|P1|Participant Flow|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
112995|NCT01721564|O1|Outcome|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
112996|NCT01721564|O1|Outcome|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
112997|NCT01721564|E1|Reported Event|Bosentan|62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
112998|NCT01721486|B3|Baseline|Total|Total of all reporting groups
112999|NCT01721486|B2|Baseline|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
113722|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
113000|NCT01721486|B1|Baseline|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
113001|NCT01721486|P2|Participant Flow|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
113002|NCT01721486|P1|Participant Flow|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
113003|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
113004|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
113005|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
113006|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
113007|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
113008|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
113009|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
113010|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
113011|NCT01721486|E2|Reported Event|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
113012|NCT01721486|E1|Reported Event|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
113013|NCT01721330|B3|Baseline|Total|Total of all reporting groups
113014|NCT01721330|B2|Baseline|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Placebo: Placebo twice a day for 6 weeks"
113015|NCT01721330|B1|Baseline|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
113016|NCT01721330|P2|Participant Flow|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Placebo: Placebo twice a day for 6 weeks"
113017|NCT01721330|P1|Participant Flow|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
113018|NCT01721330|O2|Outcome|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Placebo: Placebo twice a day for 6 weeks"
113019|NCT01721330|O1|Outcome|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
113020|NCT01721330|E2|Reported Event|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Placebo: Placebo twice a day for 6 weeks"
113021|NCT01721330|E1|Reported Event|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
113022|NCT01721317|B3|Baseline|Total|Total of all reporting groups
113023|NCT01721317|B2|Baseline|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113024|NCT01721317|B1|Baseline|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113025|NCT01721317|P2|Participant Flow|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 milligrams (mg)/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113026|NCT01721317|P1|Participant Flow|Placebo|Participants received matching ezogabine/retigabine IR placebo orally three times a day (TID) in equally or unequally divided doses.
113027|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113028|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113029|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113030|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113031|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113032|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113383|NCT01720316|E2|Reported Event|Placebo|"placebo, TID dosing, 6 weeks
placebo"
113033|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113034|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113035|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113036|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113037|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113038|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113039|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113040|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113041|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113042|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113043|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113106|NCT01721161|P1|Participant Flow|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113047|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113048|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113049|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113050|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113051|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113052|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113053|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113054|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113055|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113056|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113057|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113058|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113059|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113060|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113061|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113062|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113063|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113064|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113065|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113067|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113068|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113069|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113070|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113071|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113072|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113073|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113074|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113075|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113076|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113077|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113078|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113079|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113080|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113081|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113082|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113083|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113084|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113085|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113086|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113087|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113088|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113089|NCT01721317|E2|Reported Event|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
113090|NCT01721317|E1|Reported Event|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
113091|NCT01721226|B3|Baseline|Total|Total of all reporting groups
113092|NCT01721226|B2|Baseline|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
113093|NCT01721226|B1|Baseline|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
113094|NCT01721226|P2|Participant Flow|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
113095|NCT01721226|P1|Participant Flow|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
113723|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
113096|NCT01721226|O2|Outcome|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
113097|NCT01721226|O1|Outcome|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
113098|NCT01721226|O2|Outcome|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
113099|NCT01721226|O1|Outcome|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
113100|NCT01721226|E2|Reported Event|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
113101|NCT01721226|E1|Reported Event|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
113102|NCT01721161|B3|Baseline|Total|Total of all reporting groups
113103|NCT01721161|B2|Baseline|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113109|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113110|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113111|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113112|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113113|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113114|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113115|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113116|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113117|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113118|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113119|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113120|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113121|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113122|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113123|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113124|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113125|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113126|NCT01721161|E2|Reported Event|BIIB033 100 mg/kg|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113127|NCT01721161|E1|Reported Event|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
113128|NCT01721109|B1|Baseline|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
113129|NCT01721109|P1|Participant Flow|EVG/COBI/FTC/TDF|Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; EVG/COBI/FTC/TDF) (150/150/200/300 mg) single-tablet regiment (STR) administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase.
113130|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
113131|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
113134|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
113135|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
113136|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
113137|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
113138|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
113139|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
113140|NCT01721109|E1|Reported Event|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
113141|NCT01721096|B3|Baseline|Total|Total of all reporting groups
113142|NCT01721096|B2|Baseline|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113143|NCT01721096|B1|Baseline|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113144|NCT01721096|P2|Participant Flow|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113145|NCT01721096|P1|Participant Flow|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113146|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113147|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113148|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113149|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113150|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113151|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113152|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113153|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113154|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113155|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113156|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113157|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113158|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113159|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113160|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113161|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113162|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113163|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113164|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113165|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113166|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113167|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113168|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113169|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113170|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113171|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113172|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113173|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113174|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113175|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113177|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113178|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113179|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113180|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113181|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113182|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113183|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113184|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113185|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113186|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113187|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113188|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113189|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113190|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113191|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113192|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113193|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113194|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113195|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113196|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113197|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113198|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113199|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113200|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113201|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113202|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113203|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113204|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113205|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113206|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113207|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113208|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113209|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113210|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113211|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113212|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113213|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113214|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113215|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113216|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113217|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113218|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113219|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113220|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113221|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113223|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113224|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113225|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113226|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113227|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113228|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113229|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113230|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents
XIENCE PRIME - Core Size: Core Size"
113231|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length
XIENCE PRIME - Long Length (LL): Long Length"
113232|NCT01721096|E2|Reported Event|XIENCE PRIME - Core Size (CS)|XIENCE PRIME - Core Size: Core Size- 213 patients with 8, 12, 15, 18 or 23 mm stents.
113233|NCT01721096|E1|Reported Event|XIENCE PRIME - Long Length (LL)|XIENCE PRIME - Long Length (LL): Long Length- 323 patients receiving LL stent in 28, 33, or 38 mm length.
113234|NCT01721070|B1|Baseline|SUF NT 15 mcg Then 3 Days of Ketoconazole and SUF NT 15 mcg|"Period 1: SUF NT 15 mcg administered once sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
Period 2: Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.
Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
113235|NCT01721070|P1|Participant Flow|SUF NT 15 mcg Followed by Ketoconazole 400 mg + SUF NT 15 mcg|"Period 1: One SUF NT 15 mcg administered sublingually followed by Period 2.
Period 2: Ketoconazole 400 mg given daily for three days; One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.
Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT 15 mcg dosing to block the opioid effects of the sufentanil."
113236|NCT01721070|O2|Outcome|Ketoconazole 400 mg and SUF NT 15 mcg|"Ketoconazole 400 mg given daily for three days. One SUF NT15 mcg is also co-administered sublingually with the third (last) ketoconazole dose.
Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
113237|NCT01721070|O1|Outcome|SUF NT 15 mcg|One SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
113272|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113238|NCT01721070|O2|Outcome|Ketoconazole 400 mg and SUF NT 15 mcg|"Ketoconazole 400 mg given orally daily for three days. One SUF NT 15 mcg is also co-administered sublingually with the third (last) ketoconazole dose.
Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
113239|NCT01721070|O1|Outcome|SUF NT 15 mcg|One SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
113240|NCT01721070|E2|Reported Event|Ketoconazole 400 mg + SUF NT 15 mcg|"Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.
Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
113241|NCT01721070|E1|Reported Event|SUF NT 15 mcg|"One SUF NT 15 mcg administered sublingually.
Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
113242|NCT01721057|B4|Baseline|Total|Total of all reporting groups
113243|NCT01721057|B3|Baseline|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.
Participants continued to take background cDMARD therapy throughout study."
113244|NCT01721057|B2|Baseline|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.
Participants continued to take background cDMARD therapy throughout study."
113245|NCT01721057|B1|Baseline|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113246|NCT01721057|P7|Participant Flow|Baricitinib 4 mg- Follow Up|"No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
Includes participants who were rescued to Baricitinib 4 mg."
113247|NCT01721057|P6|Participant Flow|Baricitinib 2 mg- Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
113248|NCT01721057|P5|Participant Flow|Placebo-Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
113249|NCT01721057|P4|Participant Flow|Rescue|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
113250|NCT01721057|P3|Participant Flow|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113251|NCT01721057|P2|Participant Flow|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113252|NCT01721057|P1|Participant Flow|Placebo|"Placebo administered orally (PO) once daily (QD)through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113253|NCT01721057|O2|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study."
113254|NCT01721057|O1|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study."
113255|NCT01721057|O2|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study."
113256|NCT01721057|O1|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study."
113257|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113258|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113259|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113260|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants will continue to take background cDMARD therapy throughout study."
113261|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113262|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113263|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113264|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113265|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113266|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.
Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally daily through Week 24.
Participants will continue to take background cDMARD therapy throughout study."
113267|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study."
113268|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113269|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113270|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113271|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113363|NCT01720316|O2|Outcome|Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine|Brain glycine/CR ratio at baseline and week 6 of glycine for one participant
113273|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113274|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113275|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113276|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113277|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113278|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants will continue to take background cDMARD therapy throughout study."
113279|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113280|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113281|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113282|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113283|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113284|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113285|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113286|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113287|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113288|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113289|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113290|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study."
113291|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study."
113292|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113293|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113294|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113295|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113296|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113297|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113298|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113299|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113300|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113301|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113302|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.
Participants continued to take background cDMARD therapy throughout study."
113303|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.
Participants will continued to take background cDMARD therapy throughout study."
113304|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113305|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113306|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113307|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113495|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
113308|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113309|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113310|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113311|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113312|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113313|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD)through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113314|NCT01721057|E7|Reported Event|Baricitinib 4 mg- Follow Up|"No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
Includes participants who were rescued to Baricitinib 4 mg."
113315|NCT01721057|E6|Reported Event|Baricitinib 2 mg- Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
113316|NCT01721057|E5|Reported Event|Placebo-Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
113317|NCT01721057|E4|Reported Event|Rescue|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
113318|NCT01721057|E3|Reported Event|Baricitinib 4 Mg-Treatment Period|"Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113319|NCT01721057|E2|Reported Event|Baricitinib 2 Mg-Treatment Period|"Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study."
113320|NCT01721057|E1|Reported Event|Placebo-Treatment Period|"Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
113321|NCT01720797|B3|Baseline|Total|Total of all reporting groups
113322|NCT01720797|B2|Baseline|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
113323|NCT01720797|B1|Baseline|Micro-osteoperforation|Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
113324|NCT01720797|P2|Participant Flow|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
113343|NCT01720316|O2|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (amplitude) week 6 of glycine
113724|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
113325|NCT01720797|P1|Participant Flow|Micro-osteoperforation|"Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
Micro-osteoperforation: Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.
Anesthestic: Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.
Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week."
113326|NCT01720797|O2|Outcome|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
113327|NCT01720797|O1|Outcome|Micro-osteoperforation|Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
113328|NCT01720797|E2|Reported Event|Non Micro-osteoperforation|"Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week."
113329|NCT01720797|E1|Reported Event|Micro-osteoperforation|Minimally invasive micro-osteoperforation (PROPEL™) procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
113330|NCT01720602|B1|Baseline|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
vorinostat: Given PO
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
positron emission tomography: Correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
fludeoxyglucose F 18: Correlative studies
laboratory biomarker analysis: Correlative studies"
113364|NCT01720316|O1|Outcome|Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine|Brain glycine/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
113365|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113542|NCT01718535|B11|Baseline|Total|Total of all reporting groups
113331|NCT01720602|P1|Participant Flow|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
vorinostat: Given PO
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
positron emission tomography: Correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
fludeoxyglucose F 18: Correlative studies
laboratory biomarker analysis: Correlative studies"
113332|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
vorinostat: Given PO
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
positron emission tomography: Correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
fludeoxyglucose F 18: Correlative studies
laboratory biomarker analysis: Correlative studies"
113333|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
vorinostat: Given PO
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
positron emission tomography: Correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
fludeoxyglucose F 18: Correlative studies
laboratory biomarker analysis: Correlative studies"
113334|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
vorinostat: Given PO
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
positron emission tomography: Correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
fludeoxyglucose F 18: Correlative studies
laboratory biomarker analysis: Correlative studies"
113335|NCT01720602|E1|Reported Event|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
vorinostat: Given PO
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
positron emission tomography: Correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
fludeoxyglucose F 18: Correlative studies
laboratory biomarker analysis: Correlative studies"
113336|NCT01720316|B3|Baseline|Total|Total of all reporting groups
113337|NCT01720316|B2|Baseline|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113338|NCT01720316|B1|Baseline|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113339|NCT01720316|P2|Participant Flow|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then the participant received open-label glycine for 6 weeks.
113340|NCT01720316|P1|Participant Flow|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then the participant received open-label glycine for 6 weeks.
113341|NCT01720316|O4|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (amplitude) week 6 of glycine
113342|NCT01720316|O3|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 2|Subject2: Auditory ERPs (amplitude) baseline
113345|NCT01720316|O4|Outcome|Auditory ERPs Gamma 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (gamma phase locking) week 6 of glycine
113346|NCT01720316|O3|Outcome|Auditory ERPs Gamma Baseline: Subject 2|Subject2: Auditory ERPs (gamma phase locking) baseline
113347|NCT01720316|O2|Outcome|Auditory ERPs Gamma 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (gamma phase locking) week 6 of glycine
113348|NCT01720316|O1|Outcome|Auditory ERPs Gamma Baseline: Subject 1|Subject1: Auditory ERPs (gamma phase locking) baseline
113349|NCT01720316|O4|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (amplitude) week 6 of glycine
113350|NCT01720316|O3|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 2|Subject2: Auditory ERPs (amplitude) baseline
113351|NCT01720316|O2|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (amplitude) week 6 of glycine
113352|NCT01720316|O1|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 1|Subject1: Auditory ERPs (amplitude) baseline
113353|NCT01720316|O2|Outcome|Placebo|"placebo, TID dosing, 6 weeks
placebo"
113354|NCT01720316|O1|Outcome|Glycine|"Glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks
glycine powder: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
113355|NCT01720316|O4|Outcome|Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (latency) week 6 of glycine
113356|NCT01720316|O3|Outcome|Auditory ERPs Latency (ms) Baseline: Subject 2|Subject2: Auditory ERPs (latency) baseline
113357|NCT01720316|O2|Outcome|Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (latency) week 6 of glycine
113358|NCT01720316|O1|Outcome|Auditory ERPs Latency (ms) Baseline: Subject 1|Subject1: Auditory ERPs (latency) baseline
113359|NCT01720316|O2|Outcome|Subject2: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine|Brain GABA/CR ratio at baseline and week 6 of glycine for one participant: Subject 2
113360|NCT01720316|O1|Outcome|Subject1: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine|Brain GABA/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
113361|NCT01720316|O2|Outcome|Subject2: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine|Brain glutamate/CR ratio at baseline and week 6 of glycine for one participant: Subject 2
113362|NCT01720316|O1|Outcome|Subject1: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine|Brain glutamate/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
113543|NCT01718535|B10|Baseline|*3/*17 CYP2C19 Genotype|
113366|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113367|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113368|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113369|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113370|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113371|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113372|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113373|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113374|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113375|NCT01720316|O2|Outcome|Placebo Then Glycine|"placebo, TID dosing, 6 weeks Double-blind
placebo"
113376|NCT01720316|O1|Outcome|Glycine Then Placebo|"Glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks Double-blind
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
113377|NCT01720316|O4|Outcome|Composite Score on Glycine, Open-label|"glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
113378|NCT01720316|O3|Outcome|Composite Score on Placebo|"placebo, TID dosing, 6 weeks Double-blind
placebo"
113379|NCT01720316|O2|Outcome|Composite Score on Glycine, Double-blind|"Glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks Double-blind
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
113380|NCT01720316|O1|Outcome|Baseline|Composite Score at Baseline
113381|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113382|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
113384|NCT01720316|E1|Reported Event|Glycine|"Glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks
glycine powder: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
113385|NCT01720251|B4|Baseline|Total|Total of all reporting groups
113386|NCT01720251|B3|Baseline|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms
AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
113387|NCT01720251|B2|Baseline|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms
AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
113388|NCT01720251|B1|Baseline|Placebo|"SC injections of placebo
placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
113389|NCT01720251|P3|Participant Flow|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms
AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
113390|NCT01720251|P2|Participant Flow|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms
AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
113391|NCT01720251|P1|Participant Flow|Placebo|"SC injections of placebo
placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
113392|NCT01720251|O3|Outcome|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms
AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
113393|NCT01720251|O2|Outcome|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms
AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
113394|NCT01720251|O1|Outcome|Placebo|"SC injections of placebo
placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
113395|NCT01720251|E3|Reported Event|AllerT 100 µg|All patients having received at least one injection of Allert 100 µg (Safety Set)
113396|NCT01720251|E2|Reported Event|Allert 50 µg|All patients having received at least one injection of Allert 50 µg (Safety Set)
113397|NCT01720251|E1|Reported Event|Placebo|All patients having received at least one injection of Placebo (Safety Set)
113398|NCT01720043|B1|Baseline|All Participants|"All participants enrolled
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)"
113399|NCT01720043|P1|Participant Flow|All Participants|Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)
113400|NCT01720043|O1|Outcome|All Participants|"All participants enrolled
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)"
113401|NCT01720043|E1|Reported Event|All Participants|"All participants enrolled
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)"
113402|NCT01719861|B1|Baseline|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
113492|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
113544|NCT01718535|B9|Baseline|*2/*17 CYP2C19 Genotype|
113403|NCT01719861|P1|Participant Flow|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
113404|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
113405|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
113406|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
113407|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
113408|NCT01719861|O1|Outcome|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
113409|NCT01719861|E1|Reported Event|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
113410|NCT01719757|B1|Baseline|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily"
113411|NCT01719757|P1|Participant Flow|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily"
113412|NCT01719757|O2|Outcome|Subject|For overall satisfaction assessement of oxycodone/naloxone by subject
113413|NCT01719757|O1|Outcome|Investigator|For overall satisfaction assessement of oxycodone/naloxone by investigator
113414|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily"
113415|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily"
113416|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily"
113725|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
113417|NCT01719757|E1|Reported Event|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily"
113418|NCT01719653|B6|Baseline|Total|Total of all reporting groups
113419|NCT01719653|B5|Baseline|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.
SUPREP: SUPREP consumed as described in each arm."
113420|NCT01719653|B4|Baseline|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.
MoviPrep: MoviPrep consumed as described in each arm."
113421|NCT01719653|B3|Baseline|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113422|NCT01719653|B2|Baseline|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113423|NCT01719653|B1|Baseline|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113424|NCT01719653|P5|Participant Flow|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.
SUPREP: SUPREP consumed as described in each arm."
113425|NCT01719653|P4|Participant Flow|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.
MoviPrep: MoviPrep consumed as described in each arm."
113493|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
113494|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
113426|NCT01719653|P3|Participant Flow|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113427|NCT01719653|P2|Participant Flow|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113428|NCT01719653|P1|Participant Flow|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113429|NCT01719653|O5|Outcome|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.
SUPREP: SUPREP consumed as described in each arm."
113430|NCT01719653|O4|Outcome|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.
MoviPrep: MoviPrep consumed as described in each arm."
113431|NCT01719653|O3|Outcome|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113432|NCT01719653|O2|Outcome|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113433|NCT01719653|O1|Outcome|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113434|NCT01719653|O5|Outcome|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.
SUPREP: SUPREP consumed as described in each arm."
113435|NCT01719653|O4|Outcome|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.
MoviPrep: MoviPrep consumed as described in each arm."
113436|NCT01719653|O3|Outcome|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113470|NCT01719003|P3|Participant Flow|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
113597|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113437|NCT01719653|O2|Outcome|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113438|NCT01719653|O1|Outcome|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113439|NCT01719653|O5|Outcome|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.
SUPREP: SUPREP consumed as described in each arm."
113440|NCT01719653|O4|Outcome|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.
MoviPrep: MoviPrep consumed as described in each arm."
113441|NCT01719653|O3|Outcome|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113442|NCT01719653|O2|Outcome|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113443|NCT01719653|O1|Outcome|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113444|NCT01719653|E5|Reported Event|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.
SUPREP: SUPREP consumed as described in each arm."
113545|NCT01718535|B8|Baseline|*2/*3 CYP2C19 Genotype|
113445|NCT01719653|E4|Reported Event|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.
MoviPrep: MoviPrep consumed as described in each arm."
113446|NCT01719653|E3|Reported Event|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113447|NCT01719653|E2|Reported Event|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113448|NCT01719653|E1|Reported Event|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm."
113449|NCT01719172|B1|Baseline|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
113450|NCT01719172|P1|Participant Flow|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
113451|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
113452|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
113453|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
113454|NCT01719172|E1|Reported Event|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
113455|NCT01719003|B9|Baseline|Total|Total of all reporting groups
113456|NCT01719003|B8|Baseline|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
113457|NCT01719003|B7|Baseline|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
113458|NCT01719003|B6|Baseline|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
113459|NCT01719003|B5|Baseline|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
113460|NCT01719003|B4|Baseline|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
113461|NCT01719003|B3|Baseline|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
113462|NCT01719003|B2|Baseline|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
113463|NCT01719003|B1|Baseline|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
113464|NCT01719003|P9|Participant Flow|Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
113465|NCT01719003|P8|Participant Flow|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
113466|NCT01719003|P7|Participant Flow|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
113467|NCT01719003|P6|Participant Flow|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
113468|NCT01719003|P5|Participant Flow|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
113469|NCT01719003|P4|Participant Flow|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
113471|NCT01719003|P2|Participant Flow|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
113472|NCT01719003|P1|Participant Flow|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
113473|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
113474|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
113475|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
113476|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
113477|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
113478|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
113479|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
113480|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
113481|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
113482|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
113483|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
113484|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
113485|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
113486|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
113487|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
113488|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
113489|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
113490|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
113491|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
113496|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
113497|NCT01719003|E9|Reported Event|Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
113498|NCT01719003|E8|Reported Event|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
113499|NCT01719003|E7|Reported Event|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
113500|NCT01719003|E6|Reported Event|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
113501|NCT01719003|E5|Reported Event|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
113502|NCT01719003|E4|Reported Event|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
113503|NCT01719003|E3|Reported Event|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
113504|NCT01719003|E2|Reported Event|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
113505|NCT01719003|E1|Reported Event|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
113506|NCT01718691|B3|Baseline|Total|Total of all reporting groups
113507|NCT01718691|B2|Baseline|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
113508|NCT01718691|B1|Baseline|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
113509|NCT01718691|P2|Participant Flow|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
113510|NCT01718691|P1|Participant Flow|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.
113511|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
113512|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm.
113513|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
113514|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
113515|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
113516|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
113517|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
113518|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
113519|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
113520|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
113521|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
113522|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
113523|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
113524|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
113525|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
113526|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
113527|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
113528|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
113529|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
113530|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
113531|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
113532|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm.
113533|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
113534|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.
113535|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
113536|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
113537|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
113538|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
113539|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
113540|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
113541|NCT01718691|E1|Reported Event|SyB L-0501＋Rituximab|"Drug: SyB L-0501
A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.
Drug: rituximab
A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0."
113562|NCT01718535|P1|Participant Flow|*1/*1 CYP2C19 Genotype|
113563|NCT01718535|O10|Outcome|*3/*17 CYP2C19 Genotype|
113564|NCT01718535|O9|Outcome|*2/*17 CYP2C19 Genotype|
113565|NCT01718535|O8|Outcome|*2/*3 CYP2C19 Genotype|
113566|NCT01718535|O7|Outcome|*17/*17 CYP2C19 Genotype|
113567|NCT01718535|O6|Outcome|*1/*17 CYP2C19 Genotype|
113568|NCT01718535|O5|Outcome|*3/*3 CYP2C19 Genotype|
113569|NCT01718535|O4|Outcome|*1/*3 CYP2C19 Genotype|
113570|NCT01718535|O3|Outcome|*2/*2 CYP2C19 Genotype|
113571|NCT01718535|O2|Outcome|*1/*2 CYP2C19 Genotype|
113572|NCT01718535|O1|Outcome|*1/*1 CYP2C19 Genotype|
113573|NCT01718535|E10|Reported Event|*3/*17 CYP2C19 Genotype|
113574|NCT01718535|E9|Reported Event|*2/*17 CYP2C19 Genotype|
113575|NCT01718535|E8|Reported Event|*2/*3 CYP2C19 Genotype|
113576|NCT01718535|E7|Reported Event|*17/*17 CYP2C19 Genotype|
113577|NCT01718535|E6|Reported Event|*1/*17 CYP2C19 Genotype|
113578|NCT01718535|E5|Reported Event|*3/*3 CYP2C19 Genotype|
113579|NCT01718535|E4|Reported Event|*1/*3 CYP2C19 Genotype|
113580|NCT01718535|E3|Reported Event|*2/*2 CYP2C19 Genotype|
113581|NCT01718535|E2|Reported Event|*1/*2 CYP2C19 Genotype|
113582|NCT01718535|E1|Reported Event|*1/*1 CYP2C19 Genotype|
113583|NCT01718509|B3|Baseline|Total|Total of all reporting groups
113584|NCT01718509|B2|Baseline|SPD489|
113585|NCT01718509|B1|Baseline|PLACEBO|
113586|NCT01718509|P2|Participant Flow|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113587|NCT01718509|P1|Participant Flow|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113598|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113599|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113600|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113601|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113602|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113603|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113604|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113605|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113606|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113607|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113608|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113609|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113610|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113611|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113612|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113613|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113614|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113615|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113616|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113617|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113618|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113619|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113620|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113621|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113622|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113623|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113624|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113625|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113626|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113627|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113628|NCT01718509|E2|Reported Event|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
113629|NCT01718509|E1|Reported Event|PLACEBO|Administered once-daily, orally, for up to 12 weeks
113630|NCT01718483|B3|Baseline|Total|Total of all reporting groups
113631|NCT01718483|B2|Baseline|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113632|NCT01718483|B1|Baseline|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113633|NCT01718483|P2|Participant Flow|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 milligram (mg) administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113634|NCT01718483|P1|Participant Flow|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily, for up to 12 weeks.
113635|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113636|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113637|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113638|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113639|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113640|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113641|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113642|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113643|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113644|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113645|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113646|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113647|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113648|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113649|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113650|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113651|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113652|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113708|NCT01717989|O1|Outcome|December 2010|
113653|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113654|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113655|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113656|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113657|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113658|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113659|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113660|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113661|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113662|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113663|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113664|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113665|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113666|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113667|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113668|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113669|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113670|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113671|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113672|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113673|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113674|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113675|NCT01718483|E2|Reported Event|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
113676|NCT01718483|E1|Reported Event|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
113677|NCT01718028|B3|Baseline|Total|Total of all reporting groups
113678|NCT01718028|B2|Baseline|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
113679|NCT01718028|B1|Baseline|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
113680|NCT01718028|P2|Participant Flow|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
113681|NCT01718028|P1|Participant Flow|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
113682|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
113683|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
113684|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
113685|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
113686|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
113687|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
113688|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
113689|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
113690|NCT01718028|E2|Reported Event|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
113691|NCT01718028|E1|Reported Event|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
113692|NCT01717989|B1|Baseline|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
113693|NCT01717989|P1|Participant Flow|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
113694|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
113695|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
113696|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
113697|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
113698|NCT01717989|O1|Outcome|2010|From June through December 2010
113699|NCT01717989|O5|Outcome|December 2011|
113700|NCT01717989|O4|Outcome|September 2011|
113701|NCT01717989|O3|Outcome|June 2011|
113702|NCT01717989|O2|Outcome|March 2011|
113703|NCT01717989|O1|Outcome|December 2010|
113704|NCT01717989|O5|Outcome|December 2011|
113705|NCT01717989|O4|Outcome|September 2011|
113706|NCT01717989|O3|Outcome|June 2011|
113707|NCT01717989|O2|Outcome|March 2011|
113726|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
113727|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
113728|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
113729|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
113730|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
113731|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
113732|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
113733|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
113734|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
113735|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
113736|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
113737|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
113738|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
113739|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
113740|NCT01717989|O4|Outcome|Q3 2011|Third quarter, 2011
113741|NCT01717989|O3|Outcome|Q2 2011|Second quarter, 2011
113742|NCT01717989|O2|Outcome|Q1 2011|First quarter 2011
113743|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter, 2010
113744|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
113745|NCT01717989|O4|Outcome|Q3 2011|Third quarter, 2011
113746|NCT01717989|O3|Outcome|Q2 2011|Second quarter, 2011
113747|NCT01717989|O2|Outcome|Q1 2011|First quarter 2011
113748|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter, 2010
113749|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
113750|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
113751|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
113752|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
113753|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
113754|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
113755|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
113756|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
113757|NCT01717989|E1|Reported Event|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
113758|NCT01717976|B3|Baseline|Total|Total of all reporting groups
113759|NCT01717976|B2|Baseline|Control|usual care
113760|NCT01717976|B1|Baseline|Intervention|"primary care based nurse telephone support
DISPO ED: primary care based nurse telephone support"
113761|NCT01717976|P2|Participant Flow|Control|usual care
113762|NCT01717976|P1|Participant Flow|Intervention|"primary care based nurse telephone support
DISPO ED: primary care based nurse telephone support"
113763|NCT01717976|O2|Outcome|Control|usual care
113764|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support
DISPO ED: primary care based nurse telephone support"
113765|NCT01717976|O2|Outcome|Control|usual care
113766|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support
DISPO ED: primary care based nurse telephone support"
113767|NCT01717976|O2|Outcome|Control|usual care
113768|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support
DISPO ED: primary care based nurse telephone support"
113769|NCT01717976|O2|Outcome|Control|usual care
113770|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support
DISPO ED: primary care based nurse telephone support"
113771|NCT01717976|O2|Outcome|Control|usual care
113772|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support
DISPO ED: primary care based nurse telephone support"
113773|NCT01717976|E2|Reported Event|Control|usual care
113774|NCT01717976|E1|Reported Event|Intervention|"primary care based nurse telephone support
DISPO ED: primary care based nurse telephone support"
113775|NCT01717872|B3|Baseline|Total|Total of all reporting groups
113776|NCT01717872|B2|Baseline|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
113777|NCT01717872|B1|Baseline|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
113778|NCT01717872|P2|Participant Flow|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
113779|NCT01717872|P1|Participant Flow|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
113780|NCT01717872|O2|Outcome|MAC Blade Lifting the Epiglottis|The MAC blade was inserted under the epiglottis and lift to view the percent glottic opening
113781|NCT01717872|O1|Outcome|MAC Blade Lifting the Tongue|The MAC blade was inserted under the tongue and lifted to view the percent glottic opening
113782|NCT01717872|O2|Outcome|Miller Blade Lifting the Tongue|Miller blade was inserted under the tongue (above the epiglottis) to view the glottic opening
113783|NCT01717872|O1|Outcome|Miller Blade Lifting the Epiglottis|Miller blade was inserted under the epiglottis to lift it to view the glottic opening
113830|NCT01717768|O5|Outcome|Part 4 Cohort 1: 60 mg TID|Oral TSX-002 60 mg three times daily (TID) for 15 days
113831|NCT01717768|O4|Outcome|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113784|NCT01717872|O2|Outcome|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
113785|NCT01717872|O1|Outcome|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The percent of glottic opening (POGO) score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
113786|NCT01717872|E2|Reported Event|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
113787|NCT01717872|E1|Reported Event|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
113788|NCT01717768|B11|Baseline|Total|Total of all reporting groups
113789|NCT01717768|B10|Baseline|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113790|NCT01717768|B9|Baseline|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113791|NCT01717768|B8|Baseline|Part 4 Cohort 2: 90 mg BID/ 90 mg TID|"Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113792|NCT01717768|B7|Baseline|Part 4 Cohort 1: 60 mg BID/ 60 mg TID|"Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113793|NCT01717768|B6|Baseline|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113794|NCT01717768|B5|Baseline|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113795|NCT01717768|B4|Baseline|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113796|NCT01717768|B3|Baseline|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113797|NCT01717768|B2|Baseline|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113798|NCT01717768|B1|Baseline|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113799|NCT01717768|P12|Participant Flow|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113800|NCT01717768|P11|Participant Flow|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113801|NCT01717768|P10|Participant Flow|Part 4 Cohort 2: 90 mg TID|Oral TSX-002 90 mg TID for 15 days
113802|NCT01717768|P9|Participant Flow|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113803|NCT01717768|P8|Participant Flow|Part 4 Cohort 1: 60 mg TID|"Oral TSX-002 60 mg TID for 15 days
TSX-002 are capsules with testosterone as the active ingredient."
113804|NCT01717768|P7|Participant Flow|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113832|NCT01717768|O3|Outcome|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113833|NCT01717768|O2|Outcome|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113805|NCT01717768|P6|Participant Flow|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing."
113806|NCT01717768|P5|Participant Flow|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing."
113807|NCT01717768|P4|Participant Flow|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113808|NCT01717768|P3|Participant Flow|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113809|NCT01717768|P2|Participant Flow|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113810|NCT01717768|P1|Participant Flow|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113811|NCT01717768|O3|Outcome|Part 3:120 mg QD Treatment C|Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
113812|NCT01717768|O2|Outcome|Part 3:120 mg QD Treatment B|Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
113813|NCT01717768|O1|Outcome|Part 3:120 mg QD Treatment A|Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
113814|NCT01717768|O3|Outcome|Part 3:120 mg QD Treatment C|Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
113815|NCT01717768|O2|Outcome|Part 3:120 mg QD Treatment B|Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
113816|NCT01717768|O1|Outcome|Part 3:120 mg QD Treatment A|Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
113817|NCT01717768|O9|Outcome|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
114635|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
113818|NCT01717768|O8|Outcome|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113819|NCT01717768|O7|Outcome|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113820|NCT01717768|O6|Outcome|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113821|NCT01717768|O5|Outcome|Part 4 Cohort 1: 60 mg TID|Oral TSX-002 60 mg three times daily (TID) for 15 days
113822|NCT01717768|O4|Outcome|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113823|NCT01717768|O3|Outcome|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113824|NCT01717768|O2|Outcome|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113825|NCT01717768|O1|Outcome|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113826|NCT01717768|O9|Outcome|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113827|NCT01717768|O8|Outcome|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113828|NCT01717768|O7|Outcome|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113829|NCT01717768|O6|Outcome|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
119443|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
113834|NCT01717768|O1|Outcome|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113835|NCT01717768|E12|Reported Event|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113836|NCT01717768|E11|Reported Event|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113837|NCT01717768|E10|Reported Event|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113838|NCT01717768|E9|Reported Event|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113839|NCT01717768|E8|Reported Event|Part 4 Cohort 1: 60 mg TID|"Oral TSX-002 60 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113840|NCT01717768|E7|Reported Event|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113841|NCT01717768|E6|Reported Event|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113842|NCT01717768|E5|Reported Event|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113843|NCT01717768|E4|Reported Event|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113844|NCT01717768|E3|Reported Event|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113845|NCT01717768|E2|Reported Event|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113846|NCT01717768|E1|Reported Event|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
113847|NCT01717638|B14|Baseline|Total|Total of all reporting groups
113848|NCT01717638|B13|Baseline|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
114558|NCT01716455|P6|Participant Flow|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
113849|NCT01717638|B12|Baseline|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113850|NCT01717638|B11|Baseline|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113851|NCT01717638|B10|Baseline|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113852|NCT01717638|B9|Baseline|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113853|NCT01717638|B8|Baseline|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113854|NCT01717638|B7|Baseline|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113855|NCT01717638|B6|Baseline|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113856|NCT01717638|B5|Baseline|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114029|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
113857|NCT01717638|B4|Baseline|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113858|NCT01717638|B3|Baseline|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113859|NCT01717638|B2|Baseline|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113860|NCT01717638|B1|Baseline|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113861|NCT01717638|P13|Participant Flow|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113862|NCT01717638|P12|Participant Flow|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113863|NCT01717638|P11|Participant Flow|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113864|NCT01717638|P10|Participant Flow|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113865|NCT01717638|P9|Participant Flow|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113866|NCT01717638|P8|Participant Flow|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113867|NCT01717638|P7|Participant Flow|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113868|NCT01717638|P6|Participant Flow|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113869|NCT01717638|P5|Participant Flow|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113870|NCT01717638|P4|Participant Flow|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113871|NCT01717638|P3|Participant Flow|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114043|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114636|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
113872|NCT01717638|P2|Participant Flow|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113873|NCT01717638|P1|Participant Flow|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113874|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113875|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113876|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113877|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113878|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113879|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113880|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114437|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
113881|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113882|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113883|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113884|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113885|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113886|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113887|NCT01717638|O2|Outcome|B48 50 (After 2nd Dose)|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113888|NCT01717638|O1|Outcome|B48 50 (After 1st Dose)|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113889|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113890|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113891|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113892|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113893|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113894|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113895|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114559|NCT01716455|P5|Participant Flow|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
113896|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113897|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113898|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113899|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113900|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113901|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113902|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113903|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113904|NCT01717638|O1|Outcome|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113905|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113906|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113907|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113908|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113909|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113910|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113911|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113912|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113913|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113914|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113915|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113916|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113917|NCT01717638|O4|Outcome|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113918|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113919|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113920|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113921|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113922|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113923|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113924|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113925|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113926|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113927|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113928|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113929|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113930|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113931|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113932|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113933|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113934|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113935|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113936|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113937|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113938|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113939|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113940|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113941|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113942|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113943|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113944|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113945|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113946|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113947|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114637|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
113948|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113949|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113950|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113951|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113952|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113953|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113954|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113955|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113956|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114481|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
113957|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113958|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113959|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113960|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113961|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113962|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113963|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113964|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113965|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113966|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113967|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113968|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113969|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113970|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113971|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113972|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114560|NCT01716455|P4|Participant Flow|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
113973|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113974|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113975|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113976|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113977|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113978|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113979|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113980|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113981|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
114438|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
113982|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113983|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113984|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113985|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113986|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113987|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113988|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113989|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113990|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113991|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
113992|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113993|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113994|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113995|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113996|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113997|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113998|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
113999|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114000|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114001|NCT01717638|E13|Reported Event|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
114002|NCT01717638|E12|Reported Event|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114003|NCT01717638|E11|Reported Event|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114004|NCT01717638|E10|Reported Event|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114005|NCT01717638|E9|Reported Event|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
117600|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
114006|NCT01717638|E8|Reported Event|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114007|NCT01717638|E7|Reported Event|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114008|NCT01717638|E6|Reported Event|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114009|NCT01717638|E5|Reported Event|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114010|NCT01717638|E4|Reported Event|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114011|NCT01717638|E3|Reported Event|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114012|NCT01717638|E2|Reported Event|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114013|NCT01717638|E1|Reported Event|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
114014|NCT01717456|B3|Baseline|Total|Total of all reporting groups
114015|NCT01717456|B2|Baseline|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114016|NCT01717456|B1|Baseline|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114017|NCT01717456|P2|Participant Flow|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114018|NCT01717456|P1|Participant Flow|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
114019|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114632|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
114020|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114021|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114022|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114023|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114024|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114025|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114026|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114027|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114028|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114477|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
114030|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114031|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114032|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114033|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114034|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114035|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114036|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114037|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114038|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114039|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114040|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114041|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114042|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114044|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114045|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114046|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114047|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114048|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114049|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114050|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114051|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114099|NCT01717326|B7|Baseline|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114052|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114053|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114054|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114055|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114056|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114057|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114058|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114059|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114060|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114061|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114062|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114063|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114064|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114065|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114066|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114067|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114068|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
114069|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114070|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
114071|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114072|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114073|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114100|NCT01717326|B6|Baseline|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114478|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
114074|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114075|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114076|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114077|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114078|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114079|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114080|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114081|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114082|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
114083|NCT01717456|E2|Reported Event|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
114084|NCT01717456|E1|Reported Event|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [Mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
114085|NCT01717326|B21|Baseline|Total|Total of all reporting groups
114086|NCT01717326|B20|Baseline|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114087|NCT01717326|B19|Baseline|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114633|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
114088|NCT01717326|B18|Baseline|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114089|NCT01717326|B17|Baseline|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114090|NCT01717326|B16|Baseline|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114091|NCT01717326|B15|Baseline|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114092|NCT01717326|B14|Baseline|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114093|NCT01717326|B13|Baseline|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114094|NCT01717326|B12|Baseline|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114095|NCT01717326|B11|Baseline|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114096|NCT01717326|B10|Baseline|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114097|NCT01717326|B9|Baseline|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114098|NCT01717326|B8|Baseline|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114101|NCT01717326|B5|Baseline|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114102|NCT01717326|B4|Baseline|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114103|NCT01717326|B3|Baseline|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114104|NCT01717326|B2|Baseline|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114105|NCT01717326|B1|Baseline|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114106|NCT01717326|P20|Participant Flow|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114107|NCT01717326|P19|Participant Flow|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114108|NCT01717326|P18|Participant Flow|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114109|NCT01717326|P17|Participant Flow|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114110|NCT01717326|P16|Participant Flow|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114111|NCT01717326|P15|Participant Flow|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114112|NCT01717326|P14|Participant Flow|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114113|NCT01717326|P13|Participant Flow|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114114|NCT01717326|P12|Participant Flow|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114190|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114115|NCT01717326|P11|Participant Flow|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114116|NCT01717326|P10|Participant Flow|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114117|NCT01717326|P9|Participant Flow|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114118|NCT01717326|P8|Participant Flow|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114119|NCT01717326|P7|Participant Flow|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114120|NCT01717326|P6|Participant Flow|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114121|NCT01717326|P5|Participant Flow|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114122|NCT01717326|P4|Participant Flow|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114123|NCT01717326|P3|Participant Flow|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114124|NCT01717326|P2|Participant Flow|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114150|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114125|NCT01717326|P1|Participant Flow|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114126|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114127|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114128|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114129|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114130|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114131|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114132|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114133|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114134|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114135|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114136|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114137|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114138|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114216|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114139|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114140|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114141|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114142|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114143|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114144|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114145|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114146|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114147|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114148|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114149|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
119444|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
114151|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114152|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114153|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114154|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114155|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114156|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114157|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114158|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114159|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114160|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114161|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114162|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114163|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114164|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114165|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114166|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114167|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114168|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114169|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114170|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114171|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114172|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114173|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114174|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114175|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114176|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114177|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114178|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114179|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114180|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114181|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114182|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114183|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114184|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114185|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114186|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114187|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114188|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114189|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114634|NCT01716221|O2|Outcome|Citalopram (Week 5)|
114191|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114192|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114193|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114194|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114195|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114196|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114197|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114198|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114199|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114200|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114201|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114380|NCT01717326|E6|Reported Event|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114202|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114203|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114204|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114205|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114206|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114207|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114208|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114209|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114210|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114211|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114212|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114213|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114214|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114215|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114217|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114218|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114219|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114220|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114221|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114222|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114223|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114224|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114225|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114226|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114227|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114228|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114229|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114230|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114231|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114232|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114233|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114234|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114235|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114236|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114237|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114238|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114239|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114240|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114241|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114318|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114242|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114243|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114244|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114245|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114246|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114247|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114248|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114249|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114250|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114251|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114252|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114253|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114254|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114255|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114256|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114257|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114258|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114259|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114260|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114261|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114262|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114263|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114264|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114265|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114266|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114267|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114268|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114269|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114270|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114271|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114272|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114273|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114274|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114275|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114276|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114277|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114278|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114279|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114280|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114281|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114282|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114283|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114284|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114285|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114286|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114287|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114288|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114289|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114290|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114291|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114292|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114293|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114294|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114295|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114296|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114297|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114298|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114299|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114300|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114301|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114302|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114303|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114435|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114304|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114305|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114306|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114307|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114308|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114309|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114310|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114311|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114312|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114313|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114314|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114315|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114316|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114317|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114319|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114320|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114321|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114322|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114323|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114324|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114325|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114326|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114327|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114328|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114329|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114330|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114331|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114332|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114333|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114334|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114335|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114336|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114337|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114338|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114339|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114340|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114341|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114342|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114343|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114457|NCT01717040|E2|Reported Event|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
114344|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114345|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114346|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114347|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114348|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114349|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114350|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114351|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114352|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114353|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114354|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114355|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114356|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114357|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114358|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114359|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114360|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114361|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114362|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114363|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114364|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114365|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114366|NCT01717326|E20|Reported Event|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114367|NCT01717326|E19|Reported Event|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114368|NCT01717326|E18|Reported Event|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
114369|NCT01717326|E17|Reported Event|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114370|NCT01717326|E16|Reported Event|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114371|NCT01717326|E15|Reported Event|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114372|NCT01717326|E14|Reported Event|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114373|NCT01717326|E13|Reported Event|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114374|NCT01717326|E12|Reported Event|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114375|NCT01717326|E11|Reported Event|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114376|NCT01717326|E10|Reported Event|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
114377|NCT01717326|E9|Reported Event|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114378|NCT01717326|E8|Reported Event|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114379|NCT01717326|E7|Reported Event|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114479|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
114381|NCT01717326|E5|Reported Event|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114382|NCT01717326|E4|Reported Event|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114383|NCT01717326|E3|Reported Event|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
114384|NCT01717326|E2|Reported Event|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114385|NCT01717326|E1|Reported Event|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
114386|NCT01717313|B3|Baseline|Total|Total of all reporting groups
114387|NCT01717313|B2|Baseline|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114388|NCT01717313|B1|Baseline|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114389|NCT01717313|P2|Participant Flow|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114390|NCT01717313|P1|Participant Flow|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114391|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114392|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114393|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114394|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114395|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114396|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114397|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114398|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114399|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114400|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114401|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114402|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114403|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114404|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114405|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114406|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114456|NCT01717040|O1|Outcome|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
115305|NCT01712516|O4|Outcome|Placebo|b.i.d.
114407|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114408|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114409|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114410|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114411|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114412|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114413|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114436|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
119445|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
114414|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114415|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114416|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114417|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114418|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114419|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114420|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114421|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114422|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114423|NCT01717313|E2|Reported Event|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114424|NCT01717313|E1|Reported Event|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
114425|NCT01717287|B3|Baseline|Total|Total of all reporting groups
114426|NCT01717287|B2|Baseline|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114427|NCT01717287|B1|Baseline|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
114428|NCT01717287|P2|Participant Flow|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114429|NCT01717287|P1|Participant Flow|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
114430|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114431|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114432|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114433|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114434|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114480|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
114439|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114440|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114441|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114442|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114443|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114444|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114445|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114446|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114447|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114448|NCT01717287|E2|Reported Event|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
114449|NCT01717287|E1|Reported Event|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
114450|NCT01717040|B3|Baseline|Total|Total of all reporting groups
114451|NCT01717040|B2|Baseline|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
114452|NCT01717040|B1|Baseline|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
114453|NCT01717040|P2|Participant Flow|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
114454|NCT01717040|P1|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
114455|NCT01717040|O2|Outcome|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
114554|NCT01716455|B4|Baseline|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114458|NCT01717040|E1|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
114459|NCT01717014|B1|Baseline|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
114460|NCT01717014|P1|Participant Flow|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
114461|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
114462|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
114463|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
114464|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
114465|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
114466|NCT01717014|E1|Reported Event|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
114467|NCT01716754|B5|Baseline|Total|Total of all reporting groups
114468|NCT01716754|B4|Baseline|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab.
114469|NCT01716754|B3|Baseline|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
114470|NCT01716754|B2|Baseline|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
114471|NCT01716754|B1|Baseline|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
114472|NCT01716754|P4|Participant Flow|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab.
114473|NCT01716754|P3|Participant Flow|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
114474|NCT01716754|P2|Participant Flow|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
114475|NCT01716754|P1|Participant Flow|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
114476|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
114482|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
114483|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
114484|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
114485|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
114486|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
114487|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
114488|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
114489|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
114490|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
114491|NCT01716754|E4|Reported Event|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab
114492|NCT01716754|E3|Reported Event|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
114493|NCT01716754|E2|Reported Event|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
114494|NCT01716754|E1|Reported Event|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
114495|NCT01716663|B1|Baseline|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
114496|NCT01716663|P1|Participant Flow|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
114497|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
114498|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
114499|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
114555|NCT01716455|B3|Baseline|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114556|NCT01716455|B2|Baseline|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114500|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
114501|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
114502|NCT01716663|E1|Reported Event|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
114503|NCT01716585|B3|Baseline|Total|Total of all reporting groups
114504|NCT01716585|B2|Baseline|Placebo|Double-blind placebo for 12 weeks
114505|NCT01716585|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
114506|NCT01716585|P2|Participant Flow|Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind placebo for 12 weeks followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
114507|NCT01716585|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
114508|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
114509|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
114510|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
114511|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
114512|NCT01716585|O2|Outcome|Placebo|Double-blind placebo for 12 weeks
114513|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
114514|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
114515|NCT01716585|E3|Reported Event|Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV|Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
114516|NCT01716585|E2|Reported Event|Double Blind Placebo|Double-blind placebo for 12 weeks
114517|NCT01716585|E1|Reported Event|Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
114518|NCT01716559|B1|Baseline|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
114519|NCT01716559|P1|Participant Flow|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta (NeoRecormon) subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
114520|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
114521|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
114522|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
114523|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
114524|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
114525|NCT01716559|E1|Reported Event|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
114526|NCT01716520|B1|Baseline|UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|All participants received one of the following three treatments in one of three treatment periods QD from the DPI for 14 days: UMEC 62.5 µg inhalation powder; VI 25 µg inhalation powder; and UMEC/VI 62.5/25 µg inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg; (2) VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg; (3) UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg; (4) UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg; (5) VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg; (6) UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg. The three treatment periods were separated by a washout period of 10 to 14 days.
114557|NCT01716455|B1|Baseline|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114527|NCT01716520|P6|Participant Flow|Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg|Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
114528|NCT01716520|P5|Participant Flow|Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg|Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
114529|NCT01716520|P4|Participant Flow|Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg|Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
114530|NCT01716520|P3|Participant Flow|Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg|Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
114531|NCT01716520|P2|Participant Flow|Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg|Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
114532|NCT01716520|P1|Participant Flow|Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
114533|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114534|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114535|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114536|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114537|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114538|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114539|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114540|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114541|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114542|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114543|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114544|NCT01716520|E3|Reported Event|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114545|NCT01716520|E2|Reported Event|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114546|NCT01716520|E1|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
114547|NCT01716468|B1|Baseline|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
114548|NCT01716468|P1|Participant Flow|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
114549|NCT01716468|O1|Outcome|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
114550|NCT01716468|E1|Reported Event|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
114551|NCT01716455|B7|Baseline|Total|Total of all reporting groups
114552|NCT01716455|B6|Baseline|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114553|NCT01716455|B5|Baseline|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114561|NCT01716455|P3|Participant Flow|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114562|NCT01716455|P2|Participant Flow|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114563|NCT01716455|P1|Participant Flow|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114564|NCT01716455|O6|Outcome|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114565|NCT01716455|O5|Outcome|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114566|NCT01716455|O4|Outcome|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114567|NCT01716455|O3|Outcome|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114568|NCT01716455|O2|Outcome|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114569|NCT01716455|O1|Outcome|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114570|NCT01716455|O6|Outcome|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114571|NCT01716455|O5|Outcome|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114572|NCT01716455|O4|Outcome|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114573|NCT01716455|O3|Outcome|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114574|NCT01716455|O2|Outcome|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114575|NCT01716455|O1|Outcome|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114576|NCT01716455|E3|Reported Event|Healthy Elderly Subjects|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114577|NCT01716455|E2|Reported Event|Matched Healthy Subjects|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
117601|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
114578|NCT01716455|E1|Reported Event|Impaired Renal Function|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
114579|NCT01716234|B8|Baseline|Total|Total of all reporting groups
114580|NCT01716234|B7|Baseline|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114581|NCT01716234|B6|Baseline|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114582|NCT01716234|B5|Baseline|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114583|NCT01716234|B4|Baseline|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114584|NCT01716234|B3|Baseline|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114585|NCT01716234|B2|Baseline|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114586|NCT01716234|B1|Baseline|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114587|NCT01716234|P7|Participant Flow|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114588|NCT01716234|P6|Participant Flow|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114589|NCT01716234|P5|Participant Flow|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114590|NCT01716234|P4|Participant Flow|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114591|NCT01716234|P3|Participant Flow|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114592|NCT01716234|P2|Participant Flow|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114593|NCT01716234|P1|Participant Flow|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114594|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114595|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114596|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114597|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114598|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114599|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114600|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114601|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114602|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114603|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114604|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114605|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114606|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114607|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114608|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114609|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114610|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114611|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114612|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114613|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114614|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114615|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114616|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114617|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114618|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114619|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114620|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114621|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114622|NCT01716234|E7|Reported Event|POS 12 TID 3 Months to <2 Yrs|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114623|NCT01716234|E6|Reported Event|POS 18 TID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114624|NCT01716234|E5|Reported Event|POS 18 TID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
114625|NCT01716234|E4|Reported Event|POS 18 BID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114626|NCT01716234|E3|Reported Event|POS 18 BID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114627|NCT01716234|E2|Reported Event|POS 12 BID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114628|NCT01716234|E1|Reported Event|POS 12 BID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
114629|NCT01716221|B1|Baseline|Study Participant|the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
114630|NCT01716221|P1|Participant Flow|Study Participant|the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
114631|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
114638|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
114639|NCT01716221|O2|Outcome|Citalopram (Week 5)|
114640|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
114641|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
114642|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
114643|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
114644|NCT01716221|O2|Outcome|Citalopram (Week 5)|
114645|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
114646|NCT01716221|O5|Outcome|Baseline|unblinded 100mg Bupropion & 20mg Citalopram
114647|NCT01716221|O4|Outcome|Placebo & Placebo|"Placebo & Placebo taken orally one time per day
Placebo & Placebo"
114648|NCT01716221|O3|Outcome|Placebo & Citalopram|"Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day
Placebo & Citalopram"
114649|NCT01716221|O2|Outcome|Bupropion & Placebo|"100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day
Bupropion & Placebo"
114650|NCT01716221|O1|Outcome|Bupropion & Citalopram|"100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day or 50mg Bupropion & 10mg Citalopram taken orally one time per day
bupropion & Citalopram"
114651|NCT01716221|E4|Reported Event|Placebo & Placebo|"Placebo & Placebo taken orally one time per day
Placebo & Placebo"
114652|NCT01716221|E3|Reported Event|Placebo & Citalopram|"Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day
Placebo & Citalopram"
114653|NCT01716221|E2|Reported Event|Bupropion & Placebo|"100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day
Bupropion & Placebo"
114654|NCT01716221|E1|Reported Event|Bupropion & Citalopram|"100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day
bupropion & Citalopram"
114655|NCT01716169|B1|Baseline|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)
Helicoll: Helicoll Collagen I Wound Dressing"
114656|NCT01716169|P1|Participant Flow|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)
Helicoll: Helicoll Collagen I Wound Dressing"
114657|NCT01716169|O2|Outcome|Standard of Care Dressing - Chronic Wound|Standard of Care dressings will be applied to one chronic wound
114658|NCT01716169|O1|Outcome|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)
Helicoll: Helicoll Collagen I Wound Dressing"
114659|NCT01716169|E2|Reported Event|Standard of Care - Chronic Wound|Standard of Care wound dressings (e.g. Vaseline gauze) will be applied to one chronic wound (of approximately 6 months duration) if the subject has more than one chronic wound of approximately the same size and duration as Helicoll chronic wound.
114660|NCT01716169|E1|Reported Event|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)
Helicoll: Helicoll Collagen I Wound Dressing"
114661|NCT01716156|B4|Baseline|Total|Total of all reporting groups
114662|NCT01716156|B3|Baseline|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
114663|NCT01716156|B2|Baseline|Grazoprevir 100 mg + RBV 12 Weeks Plus Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114664|NCT01716156|B1|Baseline|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114665|NCT01716156|P3|Participant Flow|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
114666|NCT01716156|P2|Participant Flow|Grazoprevir 100 mg + RBV 12 Weeks Plus Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114667|NCT01716156|P1|Participant Flow|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114668|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
114669|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114670|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114671|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
114852|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114672|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114673|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114674|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
114675|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114676|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114677|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
114872|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114873|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114678|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114679|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114680|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV HCV GT1non-a|This group consisted of all participants with HCV GT1non-a infection, pooled across treatment arms.
114681|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV HCV GT1a|This group consisted of all participants with HCV GT1a infection pooled across treatment arms.
114682|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
114683|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
114684|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
114685|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
114686|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
114687|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
114688|NCT01716156|E2|Reported Event|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
114689|NCT01716156|E1|Reported Event|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
114690|NCT01716052|B3|Baseline|Total|Total of all reporting groups
114691|NCT01716052|B2|Baseline|Placebo|"Lactulose
placebo: Lactulose"
114692|NCT01716052|B1|Baseline|Ibuprofen|"Pfizer 200 mg caplets (Advil)
Ibuprofen"
114693|NCT01716052|P2|Participant Flow|Placebo|"Lactulose
placebo: Lactulose"
114694|NCT01716052|P1|Participant Flow|Ibuprofen|"Pfizer 200 mg caplets (Advil)
Ibuprofen"
114695|NCT01716052|O2|Outcome|Placebo|"Lactulose
placebo: Lactulose"
114696|NCT01716052|O1|Outcome|Ibuprofen|"Pfizer 200 mg caplets (Advil)
Ibuprofen"
114697|NCT01716052|E2|Reported Event|Placebo|"Lactulose
placebo: Lactulose"
114698|NCT01716052|E1|Reported Event|Ibuprofen|"Pfizer 200 mg caplets (Advil)
Ibuprofen"
114699|NCT01716013|B3|Baseline|Total|Total of all reporting groups
114700|NCT01716013|B2|Baseline|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips"
114701|NCT01716013|B1|Baseline|BondEase|"Topical Skin Adhesive
BondEase: topical skin adhesive"
114702|NCT01716013|P2|Participant Flow|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips"
114703|NCT01716013|P1|Participant Flow|BondEase|"Topical Skin Adhesive
BondEase: topical skin adhesive"
114853|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114704|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips"
114705|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive
BondEase: topical skin adhesive"
114706|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips"
114707|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive
BondEase: topical skin adhesive"
114708|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips"
114709|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive
BondEase: topical skin adhesive"
114710|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips"
114711|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive
BondEase: topical skin adhesive"
114712|NCT01716013|E2|Reported Event|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
CWCD: traditional closure methods of sutures, staples or adhesive strips"
114713|NCT01716013|E1|Reported Event|BondEase|"Topical Skin Adhesive
BondEase: topical skin adhesive"
114714|NCT01715948|B1|Baseline|A Comparison Between Wireless CROS and BAHD for SSD|"Participants who have been implanted with a BAHD over the past three years will be given a two-week trial period with a CROS hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.
CROS hearing aid: BAHD users will be fitted with the CROS hearing aid for a two-week trial period. Their hearing abilities with the CROS hearing aid will be compared to their hearing abilities with their BAHD over a two-week period."
114715|NCT01715948|P1|Participant Flow|Contralateral Routing of Signals (CROS) Hearing Aid|"Participants who have been implanted with a bone-anchored hearing device (BAHD) over the past three years will be given a two-week trial period with a Contralateral Routing of Signals (CROS) hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.
Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries."
114716|NCT01715948|O6|Outcome|SSQ Subscale - Qualities (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.
114717|NCT01715948|O5|Outcome|SSQ Subscale - Qualities (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.
114718|NCT01715948|O4|Outcome|SSQ Subscale - Spatial (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.
114719|NCT01715948|O3|Outcome|SSQ Subscale - Spatial (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.
114720|NCT01715948|O2|Outcome|SSQ Subscale - Speech (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Speech subscale of the SSQ on a 10-point scale.
114721|NCT01715948|O1|Outcome|SSQ Subscale - Speech (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Speech subscale of the SSQ on a 10-point scale.
114722|NCT01715948|O3|Outcome|WRS in Quiet to Poorer Ear|Word recognition was tested with no noise (quiet) with words presented at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
114723|NCT01715948|O2|Outcome|WRS Noise to Poorer Ear|Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
114724|NCT01715948|O1|Outcome|WRS Noise to Better Ear|Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the better ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
114725|NCT01715948|O6|Outcome|QuickSIN Noise to Poorer Ear With CROS|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the CROS.
114726|NCT01715948|O5|Outcome|QuickSIN Noise to Poorer Ear With BAHD|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the BAHD.
114727|NCT01715948|O4|Outcome|QuickSIN Noise to Poorer Ear Unaided|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing no device.
114728|NCT01715948|O3|Outcome|QuickSIN Noise to Better Ear With CROS|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the CROS.
114729|NCT01715948|O2|Outcome|QuickSIN Noise to Better Ear With BAHD|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the BAHD.
114730|NCT01715948|O1|Outcome|QuickSIN Noise to Better Ear Unaided|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing no device. The multitalker noise increases with each sentence presentation such that the signal-to-noise ratio decreases from 25 to 0 dB, in 5-dB steps, over the six sentences.
114731|NCT01715948|E2|Reported Event|CROS Aid|The intervention during which the CROS aid was trialed as part of the cross-over design
114732|NCT01715948|E1|Reported Event|BAHD|The intervention during which the BAHD was trialed as part of the cross-over design
114733|NCT01715896|B3|Baseline|Total|Total of all reporting groups
115306|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
114734|NCT01715896|B2|Baseline|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114735|NCT01715896|B1|Baseline|Golimumab 50 Milligram (mg) Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114736|NCT01715896|P2|Participant Flow|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114737|NCT01715896|P1|Participant Flow|Golimumab 50 Milligram (mg) Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114738|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114739|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114740|NCT01715896|O1|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114741|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114742|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114743|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114744|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114745|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114746|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114747|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114748|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114749|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114750|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114751|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114752|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114753|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114754|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114755|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114756|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114757|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114758|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114759|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114760|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114761|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114762|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114763|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114874|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114875|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114764|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114765|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114766|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114767|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114768|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114769|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114770|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114771|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114772|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114773|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114774|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114775|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114776|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114777|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114778|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114779|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114780|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114781|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114782|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114783|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114784|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114785|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114876|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114877|NCT01715298|E2|Reported Event|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114786|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114787|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114788|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114789|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114790|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114791|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114792|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114793|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114794|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114795|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114796|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114797|NCT01715896|E2|Reported Event|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114798|NCT01715896|E1|Reported Event|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
114799|NCT01715857|B1|Baseline|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
114800|NCT01715857|P1|Participant Flow|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
114801|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
114802|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
114803|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
114804|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
114805|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
114806|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
114807|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
114808|NCT01715857|E1|Reported Event|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
114878|NCT01715298|E1|Reported Event|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114809|NCT01715831|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114810|NCT01715831|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received disease-modifying anti-rheumatic drugs (DMARDs) in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114811|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114812|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114813|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114814|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114815|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114816|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114817|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114818|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114819|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114854|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
115307|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
114820|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114821|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114822|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114823|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114824|NCT01715831|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
114825|NCT01715415|B3|Baseline|Total|Total of all reporting groups
114826|NCT01715415|B2|Baseline|Placebo|Double-blind placebo for 12 weeks
114827|NCT01715415|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
114879|NCT01715207|B3|Baseline|Total|Total of all reporting groups
114880|NCT01715207|B2|Baseline|Atenolol|"Atenolol tablet(Negative controls, Open-label)
Atenolol"
114828|NCT01715415|P2|Participant Flow|Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
114829|NCT01715415|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
114830|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
114831|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
114832|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
114833|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
114834|NCT01715415|O2|Outcome|Placebo|Double-blind placebo for 12 weeks
114835|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
114836|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
114837|NCT01715415|E3|Reported Event|Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV|Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
114838|NCT01715415|E2|Reported Event|Double Blind Placebo|Double-blind placebo for 12 weeks
114839|NCT01715415|E1|Reported Event|Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
114840|NCT01715298|B3|Baseline|Total|Total of all reporting groups
114841|NCT01715298|B2|Baseline|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114842|NCT01715298|B1|Baseline|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114843|NCT01715298|P2|Participant Flow|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114844|NCT01715298|P1|Participant Flow|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114845|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114846|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114847|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114848|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114849|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114850|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114851|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114855|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114856|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114857|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114858|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114859|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114860|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114861|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114862|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114863|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114864|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114865|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114866|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114867|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114868|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114869|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114870|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114871|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
114881|NCT01715207|B1|Baseline|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month
Aliskiren
Atenolol"
114882|NCT01715207|P2|Participant Flow|Atenolol|"Atenolol tablet(Negative controls, Open-label)
Atenolol"
114883|NCT01715207|P1|Participant Flow|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month
Aliskiren
Atenolol"
114884|NCT01715207|O2|Outcome|Atenolol|"Atenolol tablet(Negative controls, Open-label)
Control group baseline 24 Weeks Central PWV (m/s)(26) by MRI regional PWV A (level 1-2) 3.8 (1.7) 3.6 (1.23) PWV-total (level 1-4) 5.0 (1.03) 4.9 (1.24)"
114885|NCT01715207|O1|Outcome|Atenolol and Aliskiren|Aliskiren (Norvatis) 300mg oral tablet
114886|NCT01715207|O2|Outcome|Atenolol|"Atenolol tablet(Negative controls, Open-label)
Atenolol"
114887|NCT01715207|O1|Outcome|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month
Aliskiren
Atenolol"
114888|NCT01715207|E2|Reported Event|Atenolol|"Atenolol tablet(Negative controls, Open-label)
Control (n=14) Overall rate of adverse events 10 (71.4%) moderate to severe cases 2 (14.3%) generalized symptoms 4 (28.6%) gastrointestinal symptoms 3 (21.4%) lung problems 1 (7.1%) cardiovascular symptoms 0 central nervous system symptoms 1 (7.1%) Eye, nose, throat symptoms 1 (7.1%) gynecologic problems 1 (7.1%) problems of extremities 2 (14.3%)"
114889|NCT01715207|E1|Reported Event|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month
Treatment (n=14) Overall rate of adverse events 12 (85.7%) moderate to severe cases 0 generalized symptoms 8 (57.1%) gastrointestinal symptoms 4 (28.6%) lung problems 0 cardiovascular symptoms 3 (21.4%) central nervous system symptoms 5 (35.7%) Eye, nose, throat symptoms 4 (28.6%) gynecologic problems 1 (7.1%) problems of extremities 1 (7.1%)"
114890|NCT01715129|B1|Baseline|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114891|NCT01715129|P1|Participant Flow|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114892|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114893|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114894|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114895|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114896|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114897|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114898|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114899|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114900|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114901|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114902|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114903|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114904|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114905|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114906|NCT01715129|E1|Reported Event|Triptorelin Pamoate 11.25 mg|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
114907|NCT01715064|B3|Baseline|Total|Total of all reporting groups
114908|NCT01715064|B2|Baseline|Exercise|1 hour of moderate intensity exercise.
114909|NCT01715064|B1|Baseline|Control|non-exercise control consisting of movie watching.
114910|NCT01715064|P2|Participant Flow|Exercise (1hr of Mixed-modality Exercise)|1 hour of moderate intensity exercise. The session included 5- min warm-up, 25-min of resistance training, 25-min of aerobic training, and 5-min cool-down. Each session was led by a personal trainer and supervised by an exercise physiologist.
114911|NCT01715064|P1|Participant Flow|Control (1hr of Viewing Emotionally Neutral Movie)|non-exercise control consisting of movie watching for 60 mins. the videos were short cartoon films considered to be emotionally neutral.
114912|NCT01715064|O2|Outcome|Exercise|1 hour of moderate intensity exercise.
114913|NCT01715064|O1|Outcome|Control|non-exercise control consisting of movie watching.
114914|NCT01715064|E2|Reported Event|Exercise|1 hour of moderate intensity exercise.
114915|NCT01715064|E1|Reported Event|Control|non-exercise control consisting of movie watching.
114916|NCT01714635|B4|Baseline|Total|Total of all reporting groups
114917|NCT01714635|B3|Baseline|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens"
114918|NCT01714635|B2|Baseline|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114919|NCT01714635|B1|Baseline|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114920|NCT01714635|P3|Participant Flow|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens"
114921|NCT01714635|P2|Participant Flow|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114922|NCT01714635|P1|Participant Flow|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114923|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens"
117602|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
114924|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114925|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114926|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens"
114927|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114928|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114929|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens"
114930|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114931|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114932|NCT01714635|E3|Reported Event|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens"
114933|NCT01714635|E2|Reported Event|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114934|NCT01714635|E1|Reported Event|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens"
114935|NCT01714609|B3|Baseline|Total|Total of all reporting groups
114936|NCT01714609|B2|Baseline|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.
Sorafenib: Sorafenib, 400 mg twice daily"
114937|NCT01714609|B1|Baseline|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.
Placebo: Placebo Comparator: Placebo"
114938|NCT01714609|P2|Participant Flow|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.
Sorafenib: Sorafenib, 400 mg twice daily"
114939|NCT01714609|P1|Participant Flow|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.
Placebo: Placebo Comparator: Placebo"
114940|NCT01714609|O2|Outcome|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.
Sorafenib: Sorafenib, 400 mg twice daily"
114941|NCT01714609|O1|Outcome|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.
Placebo: Placebo Comparator: Placebo"
114942|NCT01714609|E2|Reported Event|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.
Sorafenib: Sorafenib, 400 mg twice daily"
114943|NCT01714609|E1|Reported Event|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.
Placebo: Placebo Comparator: Placebo"
114944|NCT01714544|B1|Baseline|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
Cloderm Cream"
114945|NCT01714544|P1|Participant Flow|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
Cloderm Cream"
114946|NCT01714544|O1|Outcome|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
Cloderm Cream"
114947|NCT01714544|E1|Reported Event|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
Cloderm Cream"
114948|NCT01714505|B1|Baseline|Open and Closed Loop Control|"Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.
Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings."
115058|NCT01713660|P1|Participant Flow|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
115059|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
114949|NCT01714505|P2|Participant Flow|Closed-Loop Then Open-Loop Control|"Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.
Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings."
114950|NCT01714505|P1|Participant Flow|Open-Loop Then Closed-Loop Control|"Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings.
Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia."
114951|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
114965|NCT01714492|O1|Outcome|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
115035|NCT01713998|E1|Reported Event|Study Population|Includes all subjects meeting entrance criteria, consented for participation, enrolled and randomized.
114952|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.
Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
114953|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
114954|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.
Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
114955|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
114956|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.
Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
114976|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
115060|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
114957|NCT01714505|E2|Reported Event|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
114958|NCT01714505|E1|Reported Event|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.
Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
114959|NCT01714492|B1|Baseline|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
114960|NCT01714492|P1|Participant Flow|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
114961|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
114962|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
114963|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
114964|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
114966|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
114967|NCT01714492|E1|Reported Event|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
114968|NCT01714336|B3|Baseline|Total|Total of all reporting groups
114969|NCT01714336|B2|Baseline|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
114970|NCT01714336|B1|Baseline|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
114971|NCT01714336|P2|Participant Flow|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
114972|NCT01714336|P1|Participant Flow|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
114973|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
114974|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
114975|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
115055|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
115309|NCT01712516|O4|Outcome|Placebo|b.i.d.
114977|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
114978|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
114979|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
114980|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
114981|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
114982|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
114983|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
117603|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
114984|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
114985|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
114986|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
114987|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
114988|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
114989|NCT01714336|E2|Reported Event|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
114990|NCT01714336|E1|Reported Event|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
114991|NCT01714232|B1|Baseline|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
114992|NCT01714232|P1|Participant Flow|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
115056|NCT01713686|E1|Reported Event|Ulthera System Treatment|"A single triple depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
114993|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
114994|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
114995|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
114996|NCT01714232|E1|Reported Event|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
114997|NCT01714024|B4|Baseline|Total|Total of all reporting groups
114998|NCT01714024|B3|Baseline|Osteopenic Subjects|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
114999|NCT01714024|B2|Baseline|Diabetic Subjects|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
115015|NCT01713998|B2|Baseline|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
115036|NCT01713933|B1|Baseline|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115000|NCT01714024|B1|Baseline|Healthy Volunteers|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
115001|NCT01714024|P3|Participant Flow|Osteopenic Subjects|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
115002|NCT01714024|P2|Participant Flow|Diabetic Subjects|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
115003|NCT01714024|P1|Participant Flow|Healthy Volunteers|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
115004|NCT01714024|O6|Outcome|Diabetic/Titanium|"Subjects who are diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
115005|NCT01714024|O5|Outcome|Diabetic/Tantalum|"Subjects who are diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
115006|NCT01714024|O4|Outcome|Osteopenic/Titanium|"Subjects must be diagnosed with osteoporosis or osteopenia, non-diabetic, with no history of smoking within the past two years
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
115057|NCT01713660|B1|Baseline|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
115310|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
115007|NCT01714024|O3|Outcome|Osteopenic/Tantalum|"Subjects must be diagnosed with osteoporosis or osteopenia, non-diabetic, with no history of smoking within the past two years
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
115008|NCT01714024|O2|Outcome|Healthy/Titanium|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
115009|NCT01714024|O1|Outcome|Healthy/Tantalum|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks."
115010|NCT01714024|E3|Reported Event|Osteopenic Subjects|"Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
115011|NCT01714024|E2|Reported Event|Diabetic Subjects|"Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
115012|NCT01714024|E1|Reported Event|Healthy Volunteers|"Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks."
115013|NCT01713998|B4|Baseline|Total|Total of all reporting groups
115014|NCT01713998|B3|Baseline|Group C|Subjects received Ultherapy® treatment using standard (highest) energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer used at the second highest energy setting on one side of the upper face and the 7-4.5mm transducer at the standard (highest) energy setting on the contralateral side of the upper face.
115082|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
115016|NCT01713998|B1|Baseline|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
115017|NCT01713998|P3|Participant Flow|Group C|Subjects received an increased density guideline treatment over the full face. The upper face treatment was provided in a split-face treatment using the 4 MHz transducer at no higher than the second highest energy setting on one side of the upper face and the 7 MHz transducer at the highest energy setting on other side of the upper face.
115018|NCT01713998|P2|Participant Flow|Group B|Subjects received an increased density guideline treatment over the full face but with the energy reduced to the lowest level of four possible energy settings on one side of the face.
115019|NCT01713998|P1|Participant Flow|Group A|Subjects received an increased density guideline treatment over the full face but with the energy reduced to the second highest level of four possible energy settings on one side of the face.
115020|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
115021|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
115022|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
115023|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
115024|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
115025|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
115026|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
115027|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
115028|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
115029|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted) second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7 MHz transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4 MHz transducer at the second highest energy setting and the corresponding lower face side.
115030|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
115031|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
115032|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included.
115033|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
115034|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
117604|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
115037|NCT01713933|P1|Participant Flow|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115038|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115039|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115040|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115041|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115042|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115043|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115044|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115045|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115046|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115047|NCT01713933|E1|Reported Event|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
115048|NCT01713686|B1|Baseline|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
115049|NCT01713686|P1|Participant Flow|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
115050|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
115051|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
115052|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
115053|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
115054|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
115311|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
115061|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
115062|NCT01713660|E1|Reported Event|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
115063|NCT01713621|B3|Baseline|Total|Total of all reporting groups
115064|NCT01713621|B2|Baseline|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
115065|NCT01713621|B1|Baseline|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
115066|NCT01713621|P2|Participant Flow|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
115067|NCT01713621|P1|Participant Flow|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
115068|NCT01713621|O2|Outcome|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
115069|NCT01713621|O1|Outcome|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
115070|NCT01713621|E2|Reported Event|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
115071|NCT01713621|E1|Reported Event|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
115072|NCT01713608|B5|Baseline|Total|Total of all reporting groups
115073|NCT01713608|B4|Baseline|Placebo|Placebo to match OZ439 PIB for oral suspension
115074|NCT01713608|B3|Baseline|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
115075|NCT01713608|B2|Baseline|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
115076|NCT01713608|B1|Baseline|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
115077|NCT01713608|P4|Participant Flow|Placebo|Placebo to match OZ439 PIB for oral suspension
115078|NCT01713608|P3|Participant Flow|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
115079|NCT01713608|P2|Participant Flow|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
115080|NCT01713608|P1|Participant Flow|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
115081|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
115083|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
115084|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
115085|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
115086|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
115087|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
115088|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
115089|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
115090|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
115091|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
115092|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
115093|NCT01713608|E4|Reported Event|Placebo|Placebo to match OZ439 PIB for oral suspension
115094|NCT01713608|E3|Reported Event|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
115095|NCT01713608|E2|Reported Event|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
115096|NCT01713608|E1|Reported Event|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
115097|NCT01713530|B3|Baseline|Total|Total of all reporting groups
115098|NCT01713530|B2|Baseline|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
115099|NCT01713530|B1|Baseline|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
115100|NCT01713530|P2|Participant Flow|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
115101|NCT01713530|P1|Participant Flow|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
115239|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
115102|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
115103|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
115104|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
115105|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
115163|NCT01713283|B2|Baseline|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE))
115164|NCT01713283|B1|Baseline|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN))
115106|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
115107|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
115108|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
115109|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
115110|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
115111|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
115112|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
115113|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
115114|NCT01713530|E2|Reported Event|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
115115|NCT01713530|E1|Reported Event|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
115116|NCT01713400|B3|Baseline|Total|Total of all reporting groups
115117|NCT01713400|B2|Baseline|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
115118|NCT01713400|B1|Baseline|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
115165|NCT01713283|P2|Participant Flow|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
115119|NCT01713400|P2|Participant Flow|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
115120|NCT01713400|P1|Participant Flow|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
115121|NCT01713400|O2|Outcome|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
115122|NCT01713400|O1|Outcome|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
115123|NCT01713400|O2|Outcome|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
115124|NCT01713400|O1|Outcome|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
115125|NCT01713400|E2|Reported Event|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
115126|NCT01713400|E1|Reported Event|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
115127|NCT01713348|B5|Baseline|Total|Total of all reporting groups
115128|NCT01713348|B4|Baseline|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115129|NCT01713348|B3|Baseline|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115130|NCT01713348|B2|Baseline|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115308|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115131|NCT01713348|B1|Baseline|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115132|NCT01713348|P4|Participant Flow|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115133|NCT01713348|P3|Participant Flow|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115134|NCT01713348|P2|Participant Flow|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115135|NCT01713348|P1|Participant Flow|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115136|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115137|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115138|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115139|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115140|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115141|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115142|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115143|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115144|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115145|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115146|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115147|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115148|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115149|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115150|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115151|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115240|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
115152|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115153|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115154|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
115155|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115156|NCT01713348|E4|Reported Event|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100."
115157|NCT01713348|E3|Reported Event|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115158|NCT01713348|E2|Reported Event|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100."
115159|NCT01713348|E1|Reported Event|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
115160|NCT01713283|B5|Baseline|Total|Total of all reporting groups
115161|NCT01713283|B4|Baseline|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
115162|NCT01713283|B3|Baseline|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
115337|NCT01712516|E4|Reported Event|Placebo|b.i.d.
115166|NCT01713283|P1|Participant Flow|SOF+RBV 12 Wk|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
115167|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
115168|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
115169|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
115170|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
115171|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
115172|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
115173|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
115174|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
115175|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
115176|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
115177|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
115178|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
115179|NCT01713283|O2|Outcome|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
115180|NCT01713283|O1|Outcome|SOF+RBV 12 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
115181|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
115182|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
115183|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
115184|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
115185|NCT01713283|E2|Reported Event|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
115186|NCT01713283|E1|Reported Event|SOF+RBV 12 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
115210|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115241|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
115187|NCT01713036|B1|Baseline|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B: Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
115188|NCT01713036|P1|Participant Flow|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [mcgCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
115189|NCT01713036|O1|Outcome|Pimasertib|Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [μCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
115190|NCT01713036|O1|Outcome|Pimasertib|Part B : Subjects received 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
115191|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115192|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115193|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
115338|NCT01712516|E3|Reported Event|NVA237|12.5 ug b.i.d.
115194|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
115195|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
115196|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
115197|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
115198|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
115199|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115200|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115201|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115202|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115203|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115204|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115205|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115206|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115207|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115208|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115209|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115211|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115212|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115213|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115214|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115215|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115216|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
115217|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of mass balance, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
115218|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115219|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115220|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115221|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115222|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
115339|NCT01712516|E2|Reported Event|QAB149|27.5 ug b.i.d.
115223|NCT01713036|E1|Reported Event|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the IV tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 μCi) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B: Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
115224|NCT01712984|B4|Baseline|Total|Total of all reporting groups
115225|NCT01712984|B3|Baseline|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
115226|NCT01712984|B2|Baseline|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
115227|NCT01712984|B1|Baseline|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
115228|NCT01712984|P3|Participant Flow|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
115229|NCT01712984|P2|Participant Flow|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
115230|NCT01712984|P1|Participant Flow|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
115231|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
115232|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
115233|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
115234|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
115235|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
115236|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
115237|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
115238|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
115242|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
115243|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
115244|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
115245|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
115246|NCT01712984|E3|Reported Event|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
115247|NCT01712984|E2|Reported Event|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
115248|NCT01712984|E1|Reported Event|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
115249|NCT01712854|B1|Baseline|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
115250|NCT01712854|P1|Participant Flow|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
115251|NCT01712854|O1|Outcome|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
115252|NCT01712854|O1|Outcome|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
115253|NCT01712854|E1|Reported Event|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
115254|NCT01712776|B3|Baseline|Total|Total of all reporting groups
115255|NCT01712776|B2|Baseline|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.
Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
115256|NCT01712776|B1|Baseline|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.
Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
115257|NCT01712776|P2|Participant Flow|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.
Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
115258|NCT01712776|P1|Participant Flow|Placebo (Normal Saline, Nature&Apos;s Tears)|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.
Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
115259|NCT01712776|O2|Outcome|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.
Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
115260|NCT01712776|O1|Outcome|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.
Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
115261|NCT01712776|E2|Reported Event|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.
Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
115262|NCT01712776|E1|Reported Event|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.
Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
115263|NCT01712711|B3|Baseline|Total|Total of all reporting groups
115264|NCT01712711|B2|Baseline|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
115265|NCT01712711|B1|Baseline|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
115266|NCT01712711|P2|Participant Flow|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
115267|NCT01712711|P1|Participant Flow|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
115268|NCT01712711|O2|Outcome|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
115269|NCT01712711|O1|Outcome|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
115270|NCT01712711|E2|Reported Event|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
115271|NCT01712711|E1|Reported Event|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
115272|NCT01712685|B1|Baseline|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115273|NCT01712685|P1|Participant Flow|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115302|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
115303|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
115304|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115274|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115275|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115276|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115277|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115278|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115340|NCT01712516|E1|Reported Event|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115341|NCT01712399|B1|Baseline|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115279|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115280|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115281|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115282|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115283|NCT01712685|E1|Reported Event|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
115284|NCT01712516|B5|Baseline|Total|Total of all reporting groups
115285|NCT01712516|B4|Baseline|Placebo|b.i.d.
115286|NCT01712516|B3|Baseline|NVA237|12.5 ug b.i.d.
115287|NCT01712516|B2|Baseline|QAB149|27.5 ug b.i.d.
115288|NCT01712516|B1|Baseline|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115289|NCT01712516|P4|Participant Flow|Placebo|b.i.d.
115290|NCT01712516|P3|Participant Flow|NVA237|12.5 ug b.i.d.
115291|NCT01712516|P2|Participant Flow|QAB149|27.5 ug b.i.d.
115292|NCT01712516|P1|Participant Flow|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115293|NCT01712516|O4|Outcome|Placebo|b.i.d.
115294|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
115295|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
115296|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115297|NCT01712516|O4|Outcome|Placebo|b.i.d.
115298|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
115299|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
115300|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115301|NCT01712516|O4|Outcome|Placebo|b.i.d.
115312|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115313|NCT01712516|O4|Outcome|Placebo|b.i.d.
115314|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
115315|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
115316|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115317|NCT01712516|O4|Outcome|Placebo|b.i.d.
115318|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
115319|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
115320|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115321|NCT01712516|O4|Outcome|Placebo|b.i.d.
115322|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
115323|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
115324|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115325|NCT01712516|O4|Outcome|Placebo|b.i.d.
115326|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
115327|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
115328|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115329|NCT01712516|O4|Outcome|Placebo|b.i.d.
115330|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
115331|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
115332|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115333|NCT01712516|O4|Outcome|Placebo|b.i.d.
115334|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
115335|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
115336|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
115342|NCT01712399|P1|Participant Flow|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115343|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115344|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115345|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115346|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115347|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115348|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115349|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115350|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115351|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115352|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115353|NCT01712399|E1|Reported Event|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
115354|NCT01712360|B5|Baseline|Total|Total of all reporting groups
115355|NCT01712360|B4|Baseline|NAFT600 (Adult)|"Topical once a day for two weeks
NAFT600 (adult): Applied to both feet"
115356|NCT01712360|B3|Baseline|NAFT500 (Adult)|"Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area"
115357|NCT01712360|B2|Baseline|NAFT600 (Pediatric)|"Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only"
115358|NCT01712360|B1|Baseline|NAFT500 (Pediatric)|"Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area"
115359|NCT01712360|P4|Participant Flow|NAFT600 (Adult)|"Topical once a day for two weeks
NAFT600 (adult): Applied to both feet"
115360|NCT01712360|P3|Participant Flow|NAFT500 (Adult)|"Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area"
115361|NCT01712360|P2|Participant Flow|NAFT600 (Pediatric)|"Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only"
115362|NCT01712360|P1|Participant Flow|NAFT500 (Pediatric)|"Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area"
115363|NCT01712360|O6|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks
NAFT600 (adult): Applied to both feet"
115364|NCT01712360|O5|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only"
115365|NCT01712360|O4|Outcome|NAFT500 (Adult, Groin)|"Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area"
115366|NCT01712360|O3|Outcome|NAFT500 (Pediatric, Groin)|"Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area"
115367|NCT01712360|O2|Outcome|NAFT500 (Adult, Foot)|"Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area"
115368|NCT01712360|O1|Outcome|NAFT500 (Pediatric, Foot)|"Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area"
115369|NCT01712360|O4|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks
NAFT600 (adult): Applied to both feet"
115370|NCT01712360|O3|Outcome|NAFT500 (Adult)|"Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area"
115371|NCT01712360|O2|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only"
115372|NCT01712360|O1|Outcome|NAFT500 (Pediatric)|"Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area"
115373|NCT01712360|O6|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks
NAFT600 (adult): Applied to both feet"
115374|NCT01712360|O5|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only"
115375|NCT01712360|O4|Outcome|NAFT500 (Adult, Groin)|"Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area"
115376|NCT01712360|O3|Outcome|NAFT500 (Pediatric, Groin)|"Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area"
115377|NCT01712360|O2|Outcome|NAFT500 (Adult, Foot)|"Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area"
115378|NCT01712360|O1|Outcome|NAFT500 (Pediatric, Foot)|"Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area"
115379|NCT01712360|O4|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks
NAFT600 (adult): Applied to both feet"
115380|NCT01712360|O3|Outcome|NAFT500 (Adult)|"Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area"
115381|NCT01712360|O2|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only"
115382|NCT01712360|O1|Outcome|NAFT500 (Pediatric)|"Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area"
115383|NCT01712360|E4|Reported Event|NAFT600 (Adult)|"Topical once a day for two weeks
NAFT600 (adult): Applied to both feet"
115384|NCT01712360|E3|Reported Event|NAFT500 (Adult)|"Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area"
115385|NCT01712360|E2|Reported Event|NAFT600 (Pediatric)|"Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only"
115386|NCT01712360|E1|Reported Event|NAFT500 (Pediatric)|"Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area"
115387|NCT01712334|B1|Baseline|All Participants|All participants received dornase alfa (Pulmozyme) inhaled once daily by the Pari eRapid nebulizer or the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then crossed over to use the other nebulizer in Treatment Period 2 for 2 weeks.
115388|NCT01712334|P2|Participant Flow|Jet Nebulizer Then eRapid Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 2.
115389|NCT01712334|P1|Participant Flow|eRapid Nebulizer Then Jet Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 2.
115390|NCT01712334|O2|Outcome|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
115391|NCT01712334|O1|Outcome|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
115392|NCT01712334|O2|Outcome|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
115393|NCT01712334|O1|Outcome|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
115394|NCT01712334|E2|Reported Event|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
115395|NCT01712334|E1|Reported Event|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
115396|NCT01712256|B1|Baseline|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
115397|NCT01712256|P1|Participant Flow|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
115398|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
115399|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
115400|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
115401|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
115402|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
115403|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
115404|NCT01712256|E1|Reported Event|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
115405|NCT01712204|B3|Baseline|Total|Total of all reporting groups
115406|NCT01712204|B2|Baseline|AC-201 50mg Capsule BID|AC-201 50mg Capsule BID for 16 Weeks
115407|NCT01712204|B1|Baseline|Placebo Capsule BID|Placebo Capsule BID for 16 Weeks
115408|NCT01712204|P2|Participant Flow|AC-201|AC-201 50mg Capsule BID for 16 Weeks
115409|NCT01712204|P1|Participant Flow|Placebo|Placebo Capsule BID for 16 Weeks
115410|NCT01712204|O2|Outcome|AC-201|"AC-201 50mg Capsule BID for 16 Weeks
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
115411|NCT01712204|O1|Outcome|Placebo|"Placebo Capsule BID for 16 Weeks
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
115412|NCT01712204|E2|Reported Event|AC-201|"AC-201 50mg Capsule BID for 16 Weeks
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
115413|NCT01712204|E1|Reported Event|Placebo|"Placebo Capsule BID for 16 Weeks
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
115414|NCT01712178|B3|Baseline|Total|Total of all reporting groups
115415|NCT01712178|B2|Baseline|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
115416|NCT01712178|B1|Baseline|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
115417|NCT01712178|P2|Participant Flow|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
115418|NCT01712178|P1|Participant Flow|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
115419|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
115420|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
115421|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
115422|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
115423|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
115424|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
116055|NCT01710046|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
115425|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
115426|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
115427|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
115428|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
115429|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
115430|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
115431|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
115432|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
115433|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
115434|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
115435|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
115436|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
115437|NCT01712178|E2|Reported Event|Current Formulation Adalimumab 40 mg Every Other Week|
115438|NCT01712178|E1|Reported Event|New Formulation of Adalimumab 40 mg Every Other Week|
115439|NCT01712074|B4|Baseline|Total|Total of all reporting groups
115440|NCT01712074|B3|Baseline|Placebo: Double Blind Period|All participants entered the double blind period and received placebo
115441|NCT01712074|B2|Baseline|PF-05212377 30 mg: Double Blind Period|All participants entered the double blind period and received PF-05212377 30 mg
115442|NCT01712074|B1|Baseline|Not Randomized|Participants who have been discontinued during the Placebo Run-In period
115443|NCT01712074|P3|Participant Flow|Placebo: Double Blind Period|All participants that received placebo during the 12-week double blind period
115444|NCT01712074|P2|Participant Flow|PF-05212377 30 mg: Double Blind Period|All participants that received PF-05212377 30 mg during the 12-week double blind period
115445|NCT01712074|P1|Participant Flow|Placebo Run-In|Participants that received placebo during the 4-week single blind placebo run-in period
115446|NCT01712074|O3|Outcome|Placebo|All participants received placebo during double blind period
115447|NCT01712074|O2|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115448|NCT01712074|O1|Outcome|Placebo Run-in|All participants assigned to the placebo run-in period
115449|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo during double blind period
115450|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115451|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
115452|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115453|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
116933|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
115454|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115455|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
115456|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115457|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
115458|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115459|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
115460|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115461|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
115462|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115463|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
115464|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115465|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
115466|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115467|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
117605|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
115468|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115469|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
115470|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115471|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
115472|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115473|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
115474|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115475|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
115476|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115477|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
115478|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115479|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
115480|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115481|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
115482|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115483|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
115484|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115485|NCT01712074|O2|Outcome|Placebo|All participants who received placebo with non-missing ECG data during the double blind period
115486|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115487|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing clinical laboratory data during double blind period
115488|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115489|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo during double blind period
115490|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115491|NCT01712074|O2|Outcome|Placebo|All participants who received placebo contributing to the analysis during the double blind period
115492|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115493|NCT01712074|O2|Outcome|Placebo|All participants who received placebo contributing to the analysis during the double blind period
115494|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115495|NCT01712074|E3|Reported Event|Placebo|All participants receiving placebo during double blind period
115496|NCT01712074|E2|Reported Event|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
115497|NCT01712074|E1|Reported Event|Placebo Run-In|Participants received placebo during the single blind placebo run-in period
115498|NCT01712061|B3|Baseline|Total|Total of all reporting groups
115499|NCT01712061|B2|Baseline|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115500|NCT01712061|B1|Baseline|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115501|NCT01712061|P3|Participant Flow|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115502|NCT01712061|P2|Participant Flow|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
115503|NCT01712061|P1|Participant Flow|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
115504|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115505|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115506|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115507|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115508|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115509|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115510|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115511|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115512|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115513|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115514|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
117606|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
115515|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115516|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115517|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115518|NCT01712061|O2|Outcome|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
115519|NCT01712061|O1|Outcome|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
115520|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115521|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115522|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115523|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115524|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115525|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115526|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115527|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115528|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115529|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115530|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115531|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115532|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115533|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115534|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115535|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
115536|NCT01712061|E3|Reported Event|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
115537|NCT01712061|E2|Reported Event|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
115538|NCT01712061|E1|Reported Event|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
115539|NCT01712009|B4|Baseline|Total|Total of all reporting groups
115540|NCT01712009|B3|Baseline|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115541|NCT01712009|B2|Baseline|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115542|NCT01712009|B1|Baseline|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
115543|NCT01712009|P3|Participant Flow|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115544|NCT01712009|P2|Participant Flow|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115545|NCT01712009|P1|Participant Flow|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
115546|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115547|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115548|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
115549|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115550|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115551|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
115552|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
116056|NCT01710046|P2|Participant Flow|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
115553|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115554|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
115555|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115556|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115557|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
115558|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115559|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115560|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
115561|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115562|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115563|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
115564|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115565|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115566|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
115567|NCT01712009|E3|Reported Event|Loratadine 10mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115568|NCT01712009|E2|Reported Event|Naproxen 500mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
115569|NCT01712009|E1|Reported Event|No Prophylactic Intervention|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
115570|NCT01711918|B1|Baseline|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
115571|NCT01711918|P1|Participant Flow|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
115572|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
115573|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
115574|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
115575|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
115576|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
115577|NCT01711918|E1|Reported Event|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
115578|NCT01711866|B1|Baseline|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
115579|NCT01711866|P1|Participant Flow|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
115580|NCT01711866|O1|Outcome|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
115581|NCT01711866|O1|Outcome|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
115582|NCT01711866|E1|Reported Event|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
115583|NCT01711853|B1|Baseline|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
115584|NCT01711853|P1|Participant Flow|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
115585|NCT01711853|O1|Outcome|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
115586|NCT01711853|O1|Outcome|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
115587|NCT01711853|E1|Reported Event|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
115588|NCT01711736|B3|Baseline|Total|Total of all reporting groups
115589|NCT01711736|B2|Baseline|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115590|NCT01711736|B1|Baseline|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115591|NCT01711736|P2|Participant Flow|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115592|NCT01711736|P1|Participant Flow|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115762|NCT01711177|P3|Participant Flow|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
116934|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
115593|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115594|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115595|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115596|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115597|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115598|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115740|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115599|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115600|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115601|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115602|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115603|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115604|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115605|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115606|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115607|NCT01711736|O1|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115608|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115609|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115610|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115763|NCT01711177|P2|Participant Flow|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
placebo: Placebo"
115611|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115612|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115613|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115614|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115615|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115616|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115643|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115617|NCT01711736|E2|Reported Event|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115618|NCT01711736|E1|Reported Event|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
115619|NCT01711645|B1|Baseline|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115620|NCT01711645|P1|Participant Flow|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115621|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115622|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115623|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115624|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115625|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115626|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115627|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115628|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115629|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115630|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115631|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115632|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115764|NCT01711177|P1|Participant Flow|Normal Control|"Normal patient placebo
placebo: Placebo"
115633|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115634|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115635|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115636|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115637|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115638|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115639|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115640|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115641|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115642|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115644|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115645|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115646|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115647|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115648|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115649|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115650|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115651|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115652|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115653|NCT01711645|E1|Reported Event|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
115654|NCT01711424|B1|Baseline|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
115655|NCT01711424|P1|Participant Flow|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
115656|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
115657|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
115658|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
115659|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
115660|NCT01711424|E1|Reported Event|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
115661|NCT01711359|B4|Baseline|Total|Total of all reporting groups
115662|NCT01711359|B3|Baseline|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115663|NCT01711359|B2|Baseline|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115910|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
115664|NCT01711359|B1|Baseline|Methotrexate|Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115665|NCT01711359|P3|Participant Flow|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115666|NCT01711359|P2|Participant Flow|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115667|NCT01711359|P1|Participant Flow|Methotrexate|Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115668|NCT01711359|O1|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115669|NCT01711359|O1|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115670|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115671|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
117607|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
115672|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115673|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115674|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115675|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115676|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115677|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115678|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115679|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115680|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115681|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115682|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115683|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115684|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115765|NCT01711177|O3|Outcome|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
115685|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115686|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115687|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115688|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115689|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115690|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115691|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115692|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115693|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115694|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115695|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115696|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115697|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115698|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115699|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115700|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115701|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115702|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115703|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115704|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115705|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115706|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115707|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115708|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115709|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115710|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115711|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115712|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115713|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115714|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115715|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115716|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115717|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115718|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115719|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115720|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115721|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115722|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115723|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115724|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115725|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115726|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115727|NCT01711359|O3|Outcome|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115728|NCT01711359|O2|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115729|NCT01711359|O1|Outcome|Methotrexate|MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115730|NCT01711359|E7|Reported Event|Baricitinib + MTX - Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Includes participants who were rescued to Baricitinib + MTX.
115731|NCT01711359|E6|Reported Event|Baricitinib - Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
115732|NCT01711359|E5|Reported Event|Methotrexate - Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
115733|NCT01711359|E4|Reported Event|Rescue Period|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52.
115734|NCT01711359|E3|Reported Event|Baricitinib + MTX|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115735|NCT01711359|E2|Reported Event|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115736|NCT01711359|E1|Reported Event|Methotrexate|Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
115737|NCT01711216|B1|Baseline|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115738|NCT01711216|P1|Participant Flow|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115739|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
116065|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
115741|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115742|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115743|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115744|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115745|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115746|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115747|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115748|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115749|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115750|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115751|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115752|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115753|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115754|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115755|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115756|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115757|NCT01711216|E1|Reported Event|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
115758|NCT01711177|B4|Baseline|Total|Total of all reporting groups
115759|NCT01711177|B3|Baseline|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
115760|NCT01711177|B2|Baseline|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
placebo: Placebo"
115761|NCT01711177|B1|Baseline|Normal Control|"Normal patient placebo
placebo: Placebo"
115766|NCT01711177|O2|Outcome|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
placebo: Placebo"
115767|NCT01711177|O1|Outcome|Normal Control|"Normal patient placebo
placebo: Placebo"
115768|NCT01711177|E3|Reported Event|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
115769|NCT01711177|E2|Reported Event|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
placebo: Placebo"
115770|NCT01711177|E1|Reported Event|Normal Control|"Normal patient placebo
placebo: Placebo"
115771|NCT01710839|B3|Baseline|Total|Total of all reporting groups
115772|NCT01710839|B2|Baseline|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections"
115773|NCT01710839|B1|Baseline|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
115774|NCT01710839|P2|Participant Flow|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections"
116057|NCT01710046|P1|Participant Flow|Tofacitinib 10 Milligrams (mg) Twice Daily (BID)|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
115775|NCT01710839|P1|Participant Flow|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
115776|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections"
115777|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
115778|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections"
115779|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
115780|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections"
115781|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
115782|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections"
115783|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
115784|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections"
115785|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
115786|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections"
116058|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
115787|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
115788|NCT01710839|E2|Reported Event|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections"
115789|NCT01710839|E1|Reported Event|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
115790|NCT01710800|B1|Baseline|All Study Participants|Patients will be randomized to receive either PPI or placebo (sequence 1) and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes. Sequence 2 (placebo or PPI) will be administered followed by repeat 24 hour pH with impedance.
115791|NCT01710800|P1|Participant Flow|First Intervention (7 Days), Second Intervention (7 Days)|Patients will be randomized to receive either PPI or placebo (sequence 1) for 7 days and then undergo a 24 hour pH study with impedance to measure the number of reflux episode. The second sequence of medications (that is either placebo or PPI or sequence 2) will be administered followed by repeat 24 hour pH with impedance 7 days later.
115792|NCT01710800|O2|Outcome|Esomeprazole|Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes
115793|NCT01710800|O1|Outcome|Placebo Arm|Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes
115794|NCT01710800|E2|Reported Event|PPI Arm|
115795|NCT01710800|E1|Reported Event|Placebo Arm|
115796|NCT01710787|B4|Baseline|Total|Total of all reporting groups
115797|NCT01710787|B3|Baseline|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115798|NCT01710787|B2|Baseline|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115799|NCT01710787|B1|Baseline|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115800|NCT01710787|P3|Participant Flow|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115801|NCT01710787|P2|Participant Flow|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115802|NCT01710787|P1|Participant Flow|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115803|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115804|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115901|NCT01710514|B3|Baseline|Total|Total of all reporting groups
115805|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115806|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115807|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115808|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115809|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115810|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115811|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115812|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115813|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115814|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115815|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115816|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115817|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115818|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115819|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
117608|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
115820|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115821|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115822|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115823|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115824|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115825|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115826|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115827|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115828|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115829|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115830|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115831|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115832|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115833|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115834|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115835|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115836|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115837|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115838|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115839|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115840|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115841|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115842|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115843|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115844|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115845|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115846|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115847|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115902|NCT01710514|B2|Baseline|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
115848|NCT01710787|O3|Outcome|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115849|NCT01710787|O2|Outcome|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115850|NCT01710787|O1|Outcome|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115851|NCT01710787|E3|Reported Event|Placebo, 3 Sprays Unilateral|"Placebo
Placebo: 3 unilateral intranasal sprays per dose"
115852|NCT01710787|E2|Reported Event|Tetracaine Only, 3 Sprays Unilateral|"Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose"
115853|NCT01710787|E1|Reported Event|Kovacaine Mist, 3 Sprays Unilateral|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose"
115854|NCT01710657|B4|Baseline|Total|Total of all reporting groups
115855|NCT01710657|B3|Baseline|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115856|NCT01710657|B2|Baseline|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115857|NCT01710657|B1|Baseline|Placebo|"Matching Placebo for 16 weeks.
Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
115858|NCT01710657|P3|Participant Flow|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
116059|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116060|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
115859|NCT01710657|P2|Participant Flow|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115860|NCT01710657|P1|Participant Flow|Placebo|"Matching Placebo for 16 weeks.
Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
115861|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115862|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115863|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.
Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
115864|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115865|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115866|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.
Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
115867|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115868|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115869|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.
Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
115870|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115871|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115872|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.
Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
115903|NCT01710514|B1|Baseline|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
115904|NCT01710514|P2|Participant Flow|FE 999913 100 mg TID|"FE 999913 100 mg vaginal tablet TID
FE 999913 vaginal tablet"
115905|NCT01710514|P1|Participant Flow|FE 999913 100 mg BID|"FE 999913 100 mg vaginal tablet BID
FE 999913 vaginal tablet"
115873|NCT01710657|E3|Reported Event|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115874|NCT01710657|E2|Reported Event|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.
Lacosamide 50 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
Lacosamide 100 mg: - Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use"
115875|NCT01710657|E1|Reported Event|Placebo|"Matching Placebo for 16 weeks.
Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
115876|NCT01710527|B1|Baseline|Treatment T-Metformin 500 mg + Treatment R-Glucophage 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet) or treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115877|NCT01710527|P2|Participant Flow|Treatment R-Glucophage 500mg, Then Treatment T-Metformin 500mg|Participants received one tablet of treatment R (Glucophage 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment T (Metformin 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period.
115926|NCT01710501|P3|Participant Flow|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115878|NCT01710527|P1|Participant Flow|Treatment T-Metformin 500mg, Then Treatment R-Glucophage 500mg|Participants received one tablet of treatment T (Metformin 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 minutes (min) for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment R (Glucophage 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 ante meridiem (am) and 8:30 am on Day 1 (dosing day) of each study period.
115879|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115880|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115881|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115882|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115906|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
115907|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
115908|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
115883|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115884|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115885|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115886|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
116061|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116062|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
115887|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115888|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115889|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115890|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115891|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115909|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
115892|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115893|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115894|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115895|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115927|NCT01710501|P2|Participant Flow|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115896|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115897|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115898|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115899|NCT01710527|E2|Reported Event|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 h after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 24 h post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115900|NCT01710527|E1|Reported Event|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 h after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 24 h post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
115911|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
115912|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
115913|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
115914|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
115915|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
115916|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
115917|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
115918|NCT01710514|O1|Outcome|FE999913 000072 (BID/TID)|Data pooled from both BID and TID groups
115919|NCT01710514|E3|Reported Event|FE 999913 Total|Data pooled from BID and TID groups
115920|NCT01710514|E2|Reported Event|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
115921|NCT01710514|E1|Reported Event|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
115922|NCT01710501|B4|Baseline|Total|Total of all reporting groups
115923|NCT01710501|B3|Baseline|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115924|NCT01710501|B2|Baseline|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115925|NCT01710501|B1|Baseline|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
119446|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
115928|NCT01710501|P1|Participant Flow|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115929|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115930|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115931|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115932|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115933|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115934|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115935|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115936|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115937|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115938|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115939|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115940|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115941|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115942|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115943|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115944|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115945|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115946|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
116063|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116064|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
115947|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115948|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115949|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115950|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115951|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115952|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115953|NCT01710501|E3|Reported Event|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115954|NCT01710501|E2|Reported Event|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115955|NCT01710501|E1|Reported Event|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
115956|NCT01710358|B4|Baseline|Total|Total of all reporting groups
115957|NCT01710358|B3|Baseline|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX) therapy throughout study."
115958|NCT01710358|B2|Baseline|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115959|NCT01710358|B1|Baseline|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.
At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background methotrexate (MTX) therapy throughout study."
116234|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
115960|NCT01710358|P3|Participant Flow|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115961|NCT01710358|P2|Participant Flow|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115962|NCT01710358|P1|Participant Flow|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.
At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background methotrexate (MTX) therapy throughout study."
115963|NCT01710358|O1|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52
115964|NCT01710358|O1|Outcome|Baricitinib|Baricitinib 4 mg administered orally once daily through Week 52
115965|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115966|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study.
Baricitinib: Administered orally"
116052|NCT01710332|E1|Reported Event|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total)."
115967|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115968|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115969|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study.
Baricitinib: Administered orally"
115970|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115971|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115972|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115973|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115974|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115975|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115976|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115977|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116188|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
115978|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115979|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115980|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115981|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115982|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115983|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115984|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115985|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115986|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115987|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115988|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115989|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115990|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115991|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115992|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115993|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115994|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115995|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115996|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study.
Baricitinib: Administered orally"
115997|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115998|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
115999|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116000|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116001|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116002|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116003|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116004|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116005|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116006|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116007|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116008|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116009|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116010|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 52.
Participants will continue to take background MTX therapy throughout study."
116011|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib will continue to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants will continue to take background MTX therapy throughout study."
116012|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116013|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who are were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants will continued to take background MTX therapy throughout study."
116014|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116015|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116016|NCT01710358|O3|Outcome|Adalimumab|"Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116017|NCT01710358|O2|Outcome|Baricitinib|"Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116018|NCT01710358|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background MTX therapy throughout study."
116019|NCT01710358|E10|Reported Event|Adalimumab Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
116020|NCT01710358|E9|Reported Event|Baricitinib Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Participants who were rescued or switched to Baricitinib 4 mg.
116021|NCT01710358|E8|Reported Event|Placebo Follow-up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
116022|NCT01710358|E7|Reported Event|Rescue|Baricitinib 4 mg administered PO QD through Week 52 (Week 16-52).
116053|NCT01710046|B3|Baseline|Total|Total of all reporting groups
116023|NCT01710358|E6|Reported Event|Adalimumab Treatment B|"Adalimumab Treatment B (week 24-52).
Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
116024|NCT01710358|E5|Reported Event|BaricitinibTreatment B|"Baricitinib Treatment B (week 24-52).
Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52."
116025|NCT01710358|E4|Reported Event|Placebo Treatment B|"Placebo Treatment B (week 24-52).
Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.
At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
116026|NCT01710358|E3|Reported Event|Adalimumab Treatment A|"Adalimumab Treatment A (week 0-24).
Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
116027|NCT01710358|E2|Reported Event|Baricitinib Treatment A|"Baricitinib Treatment A (week 0-24).
Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52."
116028|NCT01710358|E1|Reported Event|Placebo Treatment A|"Placebo Treatment A (week 0-24).
Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.
At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52."
116029|NCT01710345|B4|Baseline|Total|Total of all reporting groups
116030|NCT01710345|B3|Baseline|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
116031|NCT01710345|B2|Baseline|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
116032|NCT01710345|B1|Baseline|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
116033|NCT01710345|P3|Participant Flow|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
116034|NCT01710345|P2|Participant Flow|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
116035|NCT01710345|P1|Participant Flow|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
116036|NCT01710345|O3|Outcome|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
116037|NCT01710345|O2|Outcome|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
116038|NCT01710345|O1|Outcome|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
116039|NCT01710345|E3|Reported Event|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
116040|NCT01710345|E2|Reported Event|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
116041|NCT01710345|E1|Reported Event|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
116042|NCT01710332|B3|Baseline|Total|Total of all reporting groups
116094|NCT01710033|B3|Baseline|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116043|NCT01710332|B2|Baseline|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).
GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
116044|NCT01710332|B1|Baseline|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).
GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
116045|NCT01710332|P2|Participant Flow|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).
GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
116046|NCT01710332|P1|Participant Flow|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).
GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
116047|NCT01710332|O2|Outcome|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
116048|NCT01710332|O1|Outcome|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total)."
116049|NCT01710332|O2|Outcome|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
116050|NCT01710332|O1|Outcome|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total)."
116051|NCT01710332|E2|Reported Event|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
116054|NCT01710046|B2|Baseline|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116066|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116067|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116068|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116069|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116070|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116071|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116072|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116073|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116074|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116075|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116076|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116077|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116078|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116079|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116080|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116081|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116082|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116083|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116084|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116085|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116086|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116087|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116088|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116089|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116090|NCT01710046|E2|Reported Event|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
116091|NCT01710046|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
116092|NCT01710033|B5|Baseline|Total|Total of all reporting groups
116093|NCT01710033|B4|Baseline|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116185|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
116186|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
116095|NCT01710033|B2|Baseline|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116096|NCT01710033|B1|Baseline|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116097|NCT01710033|P5|Participant Flow|CP-690,550 30 mg, Stage 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 2.
116098|NCT01710033|P4|Participant Flow|CP-690,550 30 mg, Stage 1|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1.
116099|NCT01710033|P3|Participant Flow|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116100|NCT01710033|P2|Participant Flow|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116101|NCT01710033|P1|Participant Flow|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (mycophenolate mofetil [MMF] with or without calcineurin inhibitor [cyclosporine {CsA} or tacrolimus {TAC}]) as per local clinical practice in Stage 1.
116102|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116103|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116207|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116104|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116105|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116106|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116107|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116108|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116109|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116110|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116111|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116112|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116113|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116114|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116115|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116187|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
116989|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
116116|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116117|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116118|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116119|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116120|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116121|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116122|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116123|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116124|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116125|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116256|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116126|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116127|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116128|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116129|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116130|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116131|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116132|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116133|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116134|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116135|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116136|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116137|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
117648|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
116138|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116139|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116140|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116141|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116142|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116143|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116144|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116145|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116146|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116147|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116148|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116149|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116150|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116151|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116152|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116153|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116154|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116155|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116156|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116157|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116158|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116159|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116160|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
117785|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg
TD-4208"
116161|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116162|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116163|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116164|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116165|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116166|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116167|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116168|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116169|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116170|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116171|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116257|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116172|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116173|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116174|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116175|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116176|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116177|NCT01710033|E4|Reported Event|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
116178|NCT01710033|E3|Reported Event|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116179|NCT01710033|E2|Reported Event|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
116180|NCT01710033|E1|Reported Event|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
116181|NCT01710020|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
116182|NCT01710020|P1|Participant Flow|CP-690,550 (10 mg OPC)|Single oral dose of CP-690,550 10 milligram (mg) oral powder for constitution (OPC) 1 to 2 hours (hrs) post-hemodialysis in Period 1 followed by single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2. A washout period of at least 14 days was maintained between each intervention period.
116183|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
116184|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
116189|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
116190|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
116191|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
116192|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
116193|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
116194|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
116195|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
116196|NCT01710020|E2|Reported Event|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
116197|NCT01710020|E1|Reported Event|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
116198|NCT01709903|B3|Baseline|Total|Total of all reporting groups
116199|NCT01709903|B2|Baseline|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116200|NCT01709903|B1|Baseline|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116201|NCT01709903|P2|Participant Flow|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116202|NCT01709903|P1|Participant Flow|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116203|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116204|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116205|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116206|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116208|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116209|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116210|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116211|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116212|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116213|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116214|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116215|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116216|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116217|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116218|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116219|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116220|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116221|NCT01709903|E2|Reported Event|Salmeterol/Fluticasone 50mcg/500mcg|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
116222|NCT01709903|E1|Reported Event|QVA149 110mcg/50mcg|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
116223|NCT01709864|B3|Baseline|Total|Total of all reporting groups
116224|NCT01709864|B2|Baseline|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116225|NCT01709864|B1|Baseline|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116226|NCT01709864|P2|Participant Flow|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116227|NCT01709864|P1|Participant Flow|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116228|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116229|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116230|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116231|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116232|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116233|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
117649|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
116235|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116236|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116237|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116238|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116239|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116240|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116241|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116242|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116243|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116244|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116245|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116246|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116247|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116248|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116249|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116250|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116251|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116252|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116253|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116254|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116255|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116258|NCT01709864|E2|Reported Event|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
116259|NCT01709864|E1|Reported Event|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
116260|NCT01709799|B4|Baseline|Total|Total of all reporting groups
116261|NCT01709799|B3|Baseline|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.
INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
116262|NCT01709799|B2|Baseline|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Polar Heart Rate monitors are used to measure THR and save resulting data.
Participants also received cognitive training every fourth week. See Cognitive Training arm for description."
116263|NCT01709799|B1|Baseline|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.
Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.
Participants also received cognitive training every fourth week. See Cognitive Training arm for description."
116264|NCT01709799|P3|Participant Flow|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.
INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
116265|NCT01709799|P2|Participant Flow|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Polar Heart Rate monitors are used to measure THR and save resulting data.
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
116309|NCT01709578|P2|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116310|NCT01709578|P1|Participant Flow|Placebo q2w|Placebo matched to sarilumab subcutaneous (SC) injection once every 2 weeks (q2w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD) for 24 weeks.
116266|NCT01709799|P1|Participant Flow|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.
Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
116267|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.
INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
116268|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116269|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116293|NCT01709786|O1|Outcome|Radical-7 Hemoglobin|Radical-7 hemoglobin measurement
119447|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
116270|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.
INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
116271|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116272|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116273|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.
INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
116274|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116311|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116312|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116275|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116276|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.
INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
116277|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116278|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116279|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.
INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
116280|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116281|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116282|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.
INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
116283|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116313|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116314|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116315|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116284|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
116285|NCT01709799|E3|Reported Event|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.
INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
116286|NCT01709799|E2|Reported Event|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Polar Heart Rate monitors are used to measure THR and save resulting data.
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
116287|NCT01709799|E1|Reported Event|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.
Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
116288|NCT01709786|B1|Baseline|Patients With Suspected Hemorrhage|There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
116289|NCT01709786|P1|Participant Flow|Patients With Suspected Hemorrhage|There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
116290|NCT01709786|O2|Outcome|CBC Hemoglobin|CBC hemoglobin measurement
116291|NCT01709786|O1|Outcome|iSTAT Hemoglobin|iSTAT hemoglobin measurement
116292|NCT01709786|O2|Outcome|CBC Hemoglobin|CBC hemoglobin measurement
116294|NCT01709786|E1|Reported Event|Radical-7 vs. CBC|All patients: Difference between Radical-Y hemoglobin measurement and CBC hemoglobin measurement
116295|NCT01709708|B3|Baseline|Total|Total of all reporting groups
116296|NCT01709708|B2|Baseline|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
116297|NCT01709708|B1|Baseline|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
116298|NCT01709708|P2|Participant Flow|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
116299|NCT01709708|P1|Participant Flow|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
116300|NCT01709708|O2|Outcome|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
116301|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
116302|NCT01709708|E2|Reported Event|Saline|Saline (Group B) will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
116303|NCT01709708|E1|Reported Event|Marcaine|"Marcaine (Group A) will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
116304|NCT01709578|B4|Baseline|Total|Total of all reporting groups
116305|NCT01709578|B3|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116306|NCT01709578|B2|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116307|NCT01709578|B1|Baseline|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116308|NCT01709578|P3|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116316|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116317|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116318|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116319|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116320|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116321|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116322|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116323|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116324|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116325|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116326|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116327|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116328|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116329|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116330|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116331|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116332|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116333|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116334|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116335|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116336|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116337|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116338|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116339|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116340|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116341|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116342|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116343|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116344|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116345|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116346|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116347|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116348|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116349|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116350|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116351|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116352|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116353|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116354|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116355|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116356|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116357|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116358|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116359|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116360|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116361|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116362|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116363|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116364|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116365|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116366|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116367|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116368|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116369|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116370|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116371|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116372|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116373|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116374|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116375|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116376|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116377|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116378|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116379|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116380|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116381|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116382|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116383|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116384|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116385|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116386|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116387|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116388|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116389|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116390|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116391|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116392|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116393|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116394|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116395|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116396|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116397|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116398|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116399|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116400|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116401|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116402|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116403|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116404|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116405|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116406|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116407|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116408|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116409|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116410|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116411|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116412|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116413|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116414|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116415|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116416|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116417|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116418|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116419|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116420|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116421|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116422|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116423|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116424|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116425|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116426|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116427|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116428|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116429|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116430|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116431|NCT01709578|O3|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116432|NCT01709578|O2|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116433|NCT01709578|O1|Outcome|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116434|NCT01709578|E3|Reported Event|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116435|NCT01709578|E2|Reported Event|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116436|NCT01709578|E1|Reported Event|Placebo q2w|Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
116437|NCT01709513|B4|Baseline|Total|Total of all reporting groups
116438|NCT01709513|B3|Baseline|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116439|NCT01709513|B2|Baseline|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116440|NCT01709513|B1|Baseline|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable lipid-modifying therapy (LMT).
116441|NCT01709513|P3|Participant Flow|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
117786|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg
TD-4208"
116442|NCT01709513|P2|Participant Flow|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116443|NCT01709513|P1|Participant Flow|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally once daily (QD) for 24 weeks and placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) for 24 weeks added to stable LMT.
116444|NCT01709513|O3|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116445|NCT01709513|O2|Outcome|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116446|NCT01709513|O1|Outcome|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116447|NCT01709513|O3|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116448|NCT01709513|O2|Outcome|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116449|NCT01709513|O1|Outcome|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116450|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116451|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116477|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116452|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116453|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116454|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116455|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116456|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116457|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116458|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116459|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116460|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116461|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116462|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116463|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116464|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116465|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116466|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116467|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116468|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116469|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116470|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116471|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116472|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116473|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116474|NCT01709513|O2|Outcome|Alirocumab 75/ up to 150|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116475|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116476|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116478|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116479|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116480|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116481|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116482|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116483|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116484|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116485|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116486|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116487|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116488|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116489|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116490|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116491|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116492|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116493|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116494|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116495|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116496|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116497|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
116498|NCT01709513|E3|Reported Event|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 22 weeks and placebo for atorvastatin/ezetimibe over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-­C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
116499|NCT01709513|E2|Reported Event|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo for alirocumab SC injection Q2W for 22 weeks added to stable LMT.
116500|NCT01709513|E1|Reported Event|Atorvastatin|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 22 weeks added to stable LMT.
116501|NCT01709500|B3|Baseline|Total|Total of all reporting groups
116502|NCT01709500|B2|Baseline|Placebo|Placebo matched to alirocumab SC injection for 78­-week treatment duration.
116503|NCT01709500|B1|Baseline|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116504|NCT01709500|P2|Participant Flow|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116542|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116505|NCT01709500|P1|Participant Flow|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116506|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116507|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116508|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116509|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116510|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116511|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116512|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116513|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116514|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116515|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116516|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116517|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116518|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116519|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116520|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116521|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116522|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116523|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116524|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116525|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116526|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116566|NCT01709474|O1|Outcome|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
116527|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116528|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116529|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116530|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116531|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116532|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116533|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116534|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116535|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116536|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116537|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116538|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116539|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116540|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116541|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116543|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116544|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116545|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116546|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116547|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116548|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116549|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116550|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116551|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116552|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116553|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116554|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116555|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116556|NCT01709500|E2|Reported Event|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
116557|NCT01709500|E1|Reported Event|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 76 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
116558|NCT01709474|B3|Baseline|Total|Total of all reporting groups
116559|NCT01709474|B2|Baseline|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
116560|NCT01709474|B1|Baseline|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
116561|NCT01709474|P2|Participant Flow|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
116562|NCT01709474|P1|Participant Flow|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
116563|NCT01709474|O2|Outcome|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
116564|NCT01709474|O1|Outcome|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
116565|NCT01709474|O2|Outcome|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
116567|NCT01709474|E2|Reported Event|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
116568|NCT01709474|E1|Reported Event|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
116569|NCT01709422|B3|Baseline|Total|Total of all reporting groups
116570|NCT01709422|B2|Baseline|Midazolam and Meperidine|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
116571|NCT01709422|B1|Baseline|Propofol,Midazolam and Meperidine|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
116572|NCT01709422|P2|Participant Flow|Conventional|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
116573|NCT01709422|P1|Participant Flow|Propofol|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
116574|NCT01709422|O2|Outcome|Midazolam and Meperidine|the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3minutes to maintain the desired level of sedation (moderate to deep sedation ) without maximum limit.
116575|NCT01709422|O1|Outcome|Propofol,Midazolam and Meperidine|the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation (moderate to deep sedation ) without maximum limit
116576|NCT01709422|O2|Outcome|Midazolam and Meperidine|the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes to maintain the desired level of sedation(moderate to deep sedation ) without maximum limit.
116714|NCT01708967|B3|Baseline|Total|Total of all reporting groups
117609|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
116577|NCT01709422|O1|Outcome|Propofol,Midazolam and Meperidine|the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation(moderate to deep sedation ) without maximum limit.
116578|NCT01709422|E2|Reported Event|Midazolam and Meperidine|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
116579|NCT01709422|E1|Reported Event|Propofol,Midazolam and Meperidine|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
116580|NCT01709383|B3|Baseline|Total|Total of all reporting groups
116581|NCT01709383|B2|Baseline|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116582|NCT01709383|B1|Baseline|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116583|NCT01709383|P2|Participant Flow|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116584|NCT01709383|P1|Participant Flow|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116585|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116586|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116587|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116588|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116589|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116590|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116591|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116638|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116592|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116593|NCT01709383|O2|Outcome|Sham Stimulation|"Sham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period."
116594|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|"TDCS was applied bilaterally, with the anodal electrode on the left temple and cathodal electrode on the right. TDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period
Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period."
116595|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116596|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116597|NCT01709383|O2|Outcome|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116598|NCT01709383|O1|Outcome|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116599|NCT01709383|E2|Reported Event|Sham Stimulation|Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116600|NCT01709383|E1|Reported Event|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
116601|NCT01709331|B1|Baseline|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
116602|NCT01709331|P1|Participant Flow|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly subcutaneous (SC) injections of human chorionic gonadotropin (hCG) 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
116603|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
116604|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
116605|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
116606|NCT01709331|E1|Reported Event|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
116607|NCT01709305|B1|Baseline|Overall Study|During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20).
116608|NCT01709305|P5|Participant Flow|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combinatino therapy for 24 weeks (Week 20 through Week 44). There were 554 participants randomized to this arm in Phase 2.
116609|NCT01709305|P4|Participant Flow|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 556 participants randomized to this arm in Phase 2.
116610|NCT01709305|P3|Participant Flow|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants randomized to this arm in Phase 2.
116749|NCT01708915|B5|Baseline|Total|Total of all reporting groups
117787|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg
TD-4208"
116611|NCT01709305|P2|Participant Flow|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 552 participants randomized to this arm in Phase 2.
116612|NCT01709305|P1|Participant Flow|Phase 1: Sitagliptin + Metformin|During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20). There were 5570 participants enrolled in Phase 1.
116613|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116614|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116615|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116616|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116617|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116618|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116619|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116620|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116621|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116622|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116715|NCT01708967|B2|Baseline|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.
Intervention: use both spray and catheter"
116623|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116624|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116625|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116626|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116627|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116628|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116629|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116630|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116631|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116632|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116633|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants that contributed to the week 44 analysis.
116634|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 551 participants that contributed to the week 44 analysis.
116635|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 502 participants that contributed to the week 44 analysis.
116636|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 501 participants that contributed to the week 44 analysis.
116637|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
117788|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg
TD-4208"
116639|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116640|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116641|NCT01709305|E5|Reported Event|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116642|NCT01709305|E4|Reported Event|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116643|NCT01709305|E3|Reported Event|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116644|NCT01709305|E2|Reported Event|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
116645|NCT01709305|E1|Reported Event|Phase 1: Sitagliptin + Metformin|During Phase 1, participants received sitagliptin 100 mg + metformin for 20 weeks (Week 0 through Week 20).
116646|NCT01709227|B3|Baseline|Total|Total of all reporting groups
116647|NCT01709227|B2|Baseline|Peritoneal Dialysis|Patients randomized to receive peritoneal dialysis
116648|NCT01709227|B1|Baseline|Furosemide|Patients randomized to receive furosemide
116649|NCT01709227|P2|Participant Flow|Peritoneal Dialysis|"Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management will be directed by CICU attending and Nephrology service
Peritoneal Dialysis: Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management and discontinuation will be directed by CICU attending and Nephrology service.
One potential outcome during use of a peritoneal dialysis catheter is the development of a Pleural Peritoneal communication. In this event, dialysis fluid is instilled in the peritoneum and then leaks into the pleural space through a defect in the diaphragm. This fluid is then drained out of a surgical chest tube. This impairs the ability to perform peritoneal dialysis and thus is a reason to not complete the randomized arm."
116898|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized
Aline HA: Implantable dermal filler"
116650|NCT01709227|P1|Participant Flow|Furosemide|"Patients randomized to the furosemide arm will be given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix will be considered poor responders. These patients may be started on PD if clinically indicated. Those who show good response (urine output >1 ml/kg/hr over subsequent 16 hours) will continue furosemide as needed to augment urine output. If they subsequently develop oliguria or fluid overload unresponsive to diuretic therapy, these patients may later be started on PD at discretion of CICU attending with consultation of nephrology service.
Furosemide: Patients randomized to the furosemide arm are given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix"
116651|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to PD
116652|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
116653|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
116654|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
116655|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
116656|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
116657|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
116658|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
116659|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
116660|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
116661|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
116662|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
116663|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
116664|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
116665|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to PD
116666|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
116667|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
116668|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
116669|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
116670|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
116671|NCT01709227|E2|Reported Event|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
116672|NCT01709227|E1|Reported Event|Furosemide|Patients randomized to furosemide
116673|NCT01709162|B3|Baseline|Total|Total of all reporting groups
116674|NCT01709162|B2|Baseline|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
116675|NCT01709162|B1|Baseline|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
116676|NCT01709162|P2|Participant Flow|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
116677|NCT01709162|P1|Participant Flow|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
116678|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
116679|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
116680|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
116681|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
116682|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
116683|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
116684|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
116685|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
116686|NCT01709162|E2|Reported Event|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
116687|NCT01709162|E1|Reported Event|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, by intravenous infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
116688|NCT01709136|B1|Baseline|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
116689|NCT01709136|P1|Participant Flow|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the Children's Hospital of Pittsburgh Pediatric Clinical and Translational Research Center (PCTRC) - See more at: http://www.chp.edu/research/our-facilities/pctrc, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate Glomerular Filtration Rate (GFR) evaluation, or a few days later at the convenience of the subject.
116690|NCT01709136|O1|Outcome|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
116691|NCT01709136|O1|Outcome|Sirolimus|Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
116692|NCT01709136|O1|Outcome|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab..
116693|NCT01709136|O1|Outcome|Sirolimus|Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
116694|NCT01709136|E1|Reported Event|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
116695|NCT01709084|B3|Baseline|Total|Total of all reporting groups
116696|NCT01709084|B2|Baseline|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
116697|NCT01709084|B1|Baseline|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
116698|NCT01709084|P2|Participant Flow|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
116699|NCT01709084|P1|Participant Flow|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
116700|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
116701|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
116750|NCT01708915|B4|Baseline|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
116702|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
116703|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
116704|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
116705|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
116706|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
116707|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
116708|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
116709|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
116710|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
116711|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
116712|NCT01709084|E2|Reported Event|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
116713|NCT01709084|E1|Reported Event|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
116716|NCT01708967|B1|Baseline|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.
Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)"
116717|NCT01708967|P2|Participant Flow|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.
Intervention: use both spray and catheter
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
116718|NCT01708967|P1|Participant Flow|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.
Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
116719|NCT01708967|O2|Outcome|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.
Intervention: use both spray and catheter
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
116720|NCT01708967|O1|Outcome|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.
Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
116751|NCT01708915|B3|Baseline|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
116752|NCT01708915|B2|Baseline|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
116753|NCT01708915|B1|Baseline|Placebo|Patients treated with placebo ointment
116754|NCT01708915|P4|Participant Flow|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
116755|NCT01708915|P3|Participant Flow|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
116721|NCT01708967|E2|Reported Event|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.
Intervention: use both spray and catheter
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
116722|NCT01708967|E1|Reported Event|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.
Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
116723|NCT01708954|B4|Baseline|Total|Total of all reporting groups
116724|NCT01708954|B3|Baseline|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116725|NCT01708954|B2|Baseline|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116726|NCT01708954|B1|Baseline|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116727|NCT01708954|P3|Participant Flow|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116728|NCT01708954|P2|Participant Flow|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116729|NCT01708954|P1|Participant Flow|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116730|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116731|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116732|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116733|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116899|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized
Aline HA: Implantable dermal filler"
116734|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116735|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116736|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116737|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116738|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116739|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116740|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116741|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116742|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116743|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116744|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116745|NCT01708954|E4|Reported Event|Arm Z (Erlotinib+Cabozantinib; Step 2)|Patients achieving disease progression in Arm A or Arm B may receive erlotinib 150mg and cabozantinib 40mg as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116746|NCT01708954|E3|Reported Event|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116747|NCT01708954|E2|Reported Event|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116748|NCT01708954|E1|Reported Event|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
116756|NCT01708915|P2|Participant Flow|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
116757|NCT01708915|P1|Participant Flow|Placebo|Patients treated with placebo ointment
116758|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
116759|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
116760|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
116761|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
116762|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
116763|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
116764|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
116765|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
116766|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
116767|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
116768|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
116769|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
116770|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
116771|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
116772|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
116773|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
116774|NCT01708915|E4|Reported Event|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide alone
116775|NCT01708915|E3|Reported Event|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
116776|NCT01708915|E2|Reported Event|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
116777|NCT01708915|E1|Reported Event|Placebo|Patients treated with placebo ointment
116778|NCT01708902|B8|Baseline|Total|Total of all reporting groups
116779|NCT01708902|B7|Baseline|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)"
119448|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
116780|NCT01708902|B6|Baseline|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.
(Data up to week 12)"
116781|NCT01708902|B5|Baseline|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
116782|NCT01708902|B4|Baseline|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
116783|NCT01708902|B3|Baseline|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
116784|NCT01708902|B2|Baseline|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
116785|NCT01708902|B1|Baseline|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
116786|NCT01708902|P7|Participant Flow|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)"
116787|NCT01708902|P6|Participant Flow|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg once daily (QD), administered oral as tablet.
(Data up to week 12)"
116788|NCT01708902|P5|Participant Flow|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
116789|NCT01708902|P4|Participant Flow|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
116790|NCT01708902|P3|Participant Flow|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg twice daily (BID), administered oral as tablet.
116791|NCT01708902|P2|Participant Flow|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg twice daily (BID), administered oral as tablet.
116792|NCT01708902|P1|Participant Flow|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg once daily (QD), administered oral as tablet.
116793|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)"
116794|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.
(Data up to week 12)"
116795|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
116796|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
116797|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
116798|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
116799|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
116800|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)"
116931|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
116801|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.
(Data up to week 12)"
116802|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
116803|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
116804|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
116805|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
116806|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
116807|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)"
116808|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.
(Data up to week 12)"
116809|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
116810|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
116811|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
116812|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
116813|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
116814|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)"
116815|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.
(Data up to week 12)"
116816|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
116900|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized
Aline HA: Implantable dermal filler"
116817|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
116818|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
116819|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
116820|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
116821|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)"
116822|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.
(Data up to week 12)"
116823|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
116824|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
116825|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
116826|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
116827|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
116828|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)"
116829|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.
(Data up to week 12)"
116830|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
116831|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
116832|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
116833|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
116834|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
116835|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
116836|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
116837|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
116838|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
116839|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
116840|NCT01708902|E10|Reported Event|APG: Linagliptin 2.5mg / Metformin 1000mg After Week 12|"Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
Data from week 12 to week 24."
116841|NCT01708902|E9|Reported Event|APG: Linagliptin 5mg - Linagliptin 2.5mg / Met After Week 12|Additional parallel group (APG): Patients who received linagliptin 5mg QD, administered oral as tablet during the first 12 weeks and switched to linagliptin 2.5mg and metformin 1000mg (met) BID, administered oral as fixed dose combination (FDC) tablet from week 12 to week 24. Data from week 12 to week 24.
116842|NCT01708902|E8|Reported Event|APG: Linagliptin 5mg After Week 12|Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet. Data from week 12 to week 24
116843|NCT01708902|E7|Reported Event|APG: Linagliptin 2.5mg / Metformin 1000mg BID up to Week 12|"Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)"
116844|NCT01708902|E6|Reported Event|APG: Linagliptin 5mg QD up to Week 12|"Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet.
(Data up to week 12)"
116845|NCT01708902|E5|Reported Event|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
116846|NCT01708902|E4|Reported Event|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients twice daily received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
116847|NCT01708902|E3|Reported Event|Main: Metformin 1000mg BID|Main Group: Patients twice daily received metformin 1000mg BID, administered oral as tablet.
116848|NCT01708902|E2|Reported Event|Main: Metformin 500mg BID|Main Group: Patients twice daily received metformin 500mg BID, administered oral as tablet.
116849|NCT01708902|E1|Reported Event|Main: Linagliptin 5mg QD|Main Group: Patients once daily received linagliptin 5mg QD, administered oral as tablet.
116850|NCT01708525|B1|Baseline|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment
Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
116851|NCT01708525|P1|Participant Flow|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment
Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
116852|NCT01708525|O2|Outcome|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment
Ulthera® System Treatment: Focused ultrasound energy delivered below the surface of the skin"
116853|NCT01708525|O1|Outcome|Untreated Tissue|Heavy water labeled tissue NOT receiving an Ultherapy® Treatment
116854|NCT01708525|E1|Reported Event|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment
Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
116855|NCT01708317|B1|Baseline|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)
ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.
We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
116856|NCT01708317|P1|Participant Flow|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)
ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.
We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
116857|NCT01708317|O4|Outcome|Final Education Period|Participants seen in SLCH ED Dec 21, 2011 through March 2012 that met ACASI inclusion/exclusion criteria. During this period education continued and no ACASI enrollment was conducted.
116858|NCT01708317|O3|Outcome|ACASI + Education|Participants seen in SLCH ED April 18 - Dec 20 2011 that met ACASI inclusion/exclusion criteria. During this period education continued and ACASI enrollment was conducted.
116859|NCT01708317|O2|Outcome|Initial Education Period|Participants seen in SLCH ED Jan 1 - April 17 2011 during initial education period that met ACASI inclusion/exclusion criteria
116860|NCT01708317|O1|Outcome|Historical Control|Participants seen in SLCH ED in 2010 that met ACASI inclusion/exclusion criteria
116861|NCT01708317|E1|Reported Event|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)
ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.
We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
116862|NCT01708291|B3|Baseline|Total|Total of all reporting groups
116863|NCT01708291|B2|Baseline|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
116864|NCT01708291|B1|Baseline|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
116990|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
116865|NCT01708291|P2|Participant Flow|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
116866|NCT01708291|P1|Participant Flow|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
116867|NCT01708291|O2|Outcome|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
116868|NCT01708291|O1|Outcome|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
116869|NCT01708291|E2|Reported Event|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
116870|NCT01708291|E1|Reported Event|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
116871|NCT01708278|B7|Baseline|Total|Total of all reporting groups
116872|NCT01708278|B6|Baseline|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116873|NCT01708278|B5|Baseline|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116874|NCT01708278|B4|Baseline|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116875|NCT01708278|B3|Baseline|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116901|NCT01708213|E1|Reported Event|Dermal Filler - Aline HA|To evaluate the safety and performance of Aline HA to treat mild to severe wrinkles in adult subjects
116902|NCT01708187|B3|Baseline|Total|Total of all reporting groups
117610|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
116876|NCT01708278|B2|Baseline|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116877|NCT01708278|B1|Baseline|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116878|NCT01708278|P6|Participant Flow|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116879|NCT01708278|P5|Participant Flow|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116880|NCT01708278|P4|Participant Flow|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116881|NCT01708278|P3|Participant Flow|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116882|NCT01708278|P2|Participant Flow|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116883|NCT01708278|P1|Participant Flow|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116884|NCT01708278|O6|Outcome|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116885|NCT01708278|O5|Outcome|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116886|NCT01708278|O4|Outcome|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116932|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
116887|NCT01708278|O3|Outcome|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116888|NCT01708278|O2|Outcome|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116889|NCT01708278|O1|Outcome|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116890|NCT01708278|E6|Reported Event|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116891|NCT01708278|E5|Reported Event|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116892|NCT01708278|E4|Reported Event|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116893|NCT01708278|E3|Reported Event|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116894|NCT01708278|E2|Reported Event|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin
Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
116895|NCT01708278|E1|Reported Event|Sugar Chew-Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin
Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
116896|NCT01708213|B1|Baseline|Dermal Filler - Aline HA|"Single armed study
Aline HA: Implantable dermal filler"
116897|NCT01708213|P1|Participant Flow|Dermal Filler - Aline HA|"Non-Randomized
Aline HA: Implantable dermal filler"
116903|NCT01708187|B2|Baseline|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
116904|NCT01708187|B1|Baseline|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
116905|NCT01708187|P2|Participant Flow|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
116906|NCT01708187|P1|Participant Flow|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
116907|NCT01708187|O2|Outcome|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
116908|NCT01708187|O1|Outcome|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
116909|NCT01708187|E2|Reported Event|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
116910|NCT01708187|E1|Reported Event|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
116911|NCT01708174|B4|Baseline|Total|Total of all reporting groups
116912|NCT01708174|B3|Baseline|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
116913|NCT01708174|B2|Baseline|Sonidegib (LDE225) Adults|600 mg orally
116914|NCT01708174|B1|Baseline|Sonidegib (LDE225) Children|500 mg/m2 orally
116915|NCT01708174|P3|Participant Flow|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
116916|NCT01708174|P2|Participant Flow|Sonidegib (LDE225) Adults|600 mg orally
116917|NCT01708174|P1|Participant Flow|Sonidegib (LDE225) Children|500 mg/m2 orally
116918|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
116919|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
116920|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
116921|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
116922|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
116923|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
116924|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
116925|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
116926|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
116927|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
116928|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
116929|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
116930|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
116935|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
116936|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
116937|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
116938|NCT01708174|E4|Reported Event|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
116939|NCT01708174|E3|Reported Event|Sonidegib (Total)|Sonidegib (Total)
116940|NCT01708174|E2|Reported Event|Sonidegib (LDE225) Adults|600 mg orally
116941|NCT01708174|E1|Reported Event|Sonidegib (LDE225) Children|500 mg/m2 orally
116942|NCT01708122|B3|Baseline|Total|Total of all reporting groups
116943|NCT01708122|B2|Baseline|Placebo|"Subjects will receive intranasal saline as placebo.
Saline: Sodium Chloride 0.9% intranasal spray"
116944|NCT01708122|B1|Baseline|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl
Fentanyl: 100 mcg in 1 mL intranasal spray"
116945|NCT01708122|P2|Participant Flow|Fentanyl|Subjects receiving either 50mcg or 100mcg
116946|NCT01708122|P1|Participant Flow|Placebo|"Subjects will receive 0.1 mL of intranasal saline as placebo.
saline: Sodium Chloride 0.9% intranasal spray"
116947|NCT01708122|O2|Outcome|Placebo|"Subjects will receive intranasal saline as placebo.
Saline: Sodium Chloride 0.9% intranasal spray"
116948|NCT01708122|O1|Outcome|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl
Fentanyl: 100 mcg in 1 mL intranasal spray"
116949|NCT01708122|O2|Outcome|Placebo|"Subjects will receive intranasal saline as placebo.
Saline: Sodium Chloride 0.9% intranasal spray"
116950|NCT01708122|O1|Outcome|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl
Fentanyl: 100 mcg in 1 mL intranasal spray"
116951|NCT01708122|E2|Reported Event|Placebo|"Subjects receiving either 0.5mL or 1 mL intranasal saline as placebo.
Saline: Sodium Chloride 0.9% intranasal spray"
116952|NCT01708122|E1|Reported Event|Fentanyl|"Subjects receiving either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)
Fentanyl: 100 mcg in 1 mL intranasal spray"
116953|NCT01708057|B1|Baseline|Total Baseline|All Patients population
116954|NCT01708057|P3|Participant Flow|DCEBFA|AZD8683 900 ug followed by AZD8683 300 ug followed by Spiriva® 18 ug followed by AZD8683 150 ug followed by Placebo followed by AZD8683 50 ug
116955|NCT01708057|P2|Participant Flow|FEADBC|Placebo followed by Spiriva® 18 ug followed by AZD8683 50 ug followed by AZD8683 900 ug followed by AZD8683 150 ug followed by AZD8683 300 ug
117611|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
116956|NCT01708057|P1|Participant Flow|AFBECD|AZD8683 50 ug followed by Placebo followed by AZD8683 150 ug followed by Spiriva® 18 ug followed by AZD8683 300 ug followed by AZD8683 900 ug
116957|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116958|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
116959|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
116960|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
116961|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116962|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116963|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116964|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
116965|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
116966|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
116967|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116968|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116969|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116970|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
116971|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
116972|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
116973|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116974|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116975|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116976|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
116977|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
116978|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
116979|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116980|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116981|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116982|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
116983|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
116984|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
116985|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116986|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116987|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116988|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
116991|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116992|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116993|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116994|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
116995|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
116996|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
116997|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116998|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
116999|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
117000|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
117001|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
117002|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
117003|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
117004|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
117005|NCT01708057|E6|Reported Event|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
117006|NCT01708057|E5|Reported Event|18ug Spiriva|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
117007|NCT01708057|E4|Reported Event|900 ug AZD8683|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler;
117008|NCT01708057|E3|Reported Event|300 ug AZD8683|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
117009|NCT01708057|E2|Reported Event|150 ug AZD8683|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
117010|NCT01708057|E1|Reported Event|50ug AZD8683|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
117011|NCT01707667|B3|Baseline|Total|Total of all reporting groups
119449|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
117012|NCT01707667|B2|Baseline|PEG-PRU|Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
117013|NCT01707667|B1|Baseline|PRU-PEG|A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
117014|NCT01707667|P2|Participant Flow|PEG-PRU|Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
117015|NCT01707667|P1|Participant Flow|PRU-PEG|A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
117016|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
117017|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
117018|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
117019|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
117020|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
117021|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
117022|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
117023|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
117024|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
117025|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
117026|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
117027|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
117028|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
117029|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
117030|NCT01707667|E2|Reported Event|Polyethylene Glycol|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
117031|NCT01707667|E1|Reported Event|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
117032|NCT01707654|B1|Baseline|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
117033|NCT01707654|P1|Participant Flow|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
117789|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg
TD-4208"
117034|NCT01707654|O1|Outcome|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
117035|NCT01707654|E1|Reported Event|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
117036|NCT01707290|B3|Baseline|Total|Total of all reporting groups
117037|NCT01707290|B2|Baseline|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
117038|NCT01707290|B1|Baseline|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet, q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
117039|NCT01707290|P2|Participant Flow|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
117040|NCT01707290|P1|Participant Flow|Ivacaftor Arm|Participants who received Ivacaftor 150 milligram (mg) tablet and/or Placebo matched to Ivacaftor tablet, every 12 hours (q12h) in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
117041|NCT01707290|O1|Outcome|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet, orally, q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
117042|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117043|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
119450|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
117044|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117045|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117046|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117047|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117048|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117049|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117050|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117051|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117052|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117053|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117054|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117055|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117056|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
117057|NCT01707290|O1|Outcome|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
117058|NCT01707290|E2|Reported Event|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
117139|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117790|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg
TD-4208"
117059|NCT01707290|E1|Reported Event|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
117060|NCT01707238|B3|Baseline|Total|Total of all reporting groups
117061|NCT01707238|B2|Baseline|Etafilcon A Then Stenfilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
117062|NCT01707238|B1|Baseline|Stenfilcon A Then Etafilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
117063|NCT01707238|P2|Participant Flow|Etafilcon A Then Stenfilcon A|All subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
117064|NCT01707238|P1|Participant Flow|Stenfilcon A Then Etafilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
117065|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
117066|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
117067|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
117068|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
117069|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
117070|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
119451|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
117071|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
117072|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.).
117073|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
117074|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
117075|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
117076|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
117077|NCT01707238|E2|Reported Event|Etafilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
117078|NCT01707238|E1|Reported Event|Stenfilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
117079|NCT01707225|B1|Baseline|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.
Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
117080|NCT01707225|P1|Participant Flow|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.
Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
117273|NCT01706588|B5|Baseline|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117081|NCT01707225|O1|Outcome|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.
Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
117082|NCT01707225|O1|Outcome|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.
Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
117083|NCT01707225|E1|Reported Event|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.
Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
117084|NCT01707095|B3|Baseline|Total|Total of all reporting groups
117085|NCT01707095|B2|Baseline|Unbundling of Cords|"The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another
Unbundling of cords: The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another"
117612|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117086|NCT01707095|B1|Baseline|Bundling of Cords|"The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.
Bundling of cords: The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy."
117087|NCT01707095|P2|Participant Flow|Unbundled / Separated|Active electrode cord and camera cord separated
117088|NCT01707095|P1|Participant Flow|Bundled|Active electrode cord and camera cord parallel
117089|NCT01707095|O2|Outcome|Unbundled / Separated|Active electrode cord and camera cord separated
117090|NCT01707095|O1|Outcome|Bundled|Active electrode cord and camera cord parallel
117091|NCT01707095|O2|Outcome|Unbundled / Separated|Active electrode cord and camera cord separated
117092|NCT01707095|O1|Outcome|Bundled|Active electrode cord and camera cord parallel
117093|NCT01707095|E2|Reported Event|Unbundled / Separated|Active electrode cord and camera cord separated
117094|NCT01707095|E1|Reported Event|Bundled|Active electrode cord and camera cord parallel
117095|NCT01707043|B3|Baseline|Total|Total of all reporting groups
117096|NCT01707043|B2|Baseline|Taclonex Ointment First Then Taclonex Scalp Suspension|All subjects will use Taclonex Ointment to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Scalp Suspension for 3 days.There is no washout between products.
117097|NCT01707043|B1|Baseline|Taclonex Scalp Suspension First, the Taclonex Ointment|All subjects will use Taclonex Scalp Suspension first to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Ointment for 3 days.There is no washout between products.
117098|NCT01707043|P2|Participant Flow|Taclonex Ointment First, Then Taclonex Scalp Suspension|All subjects will use Taclonex Ointment to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Scalp Suspension for 3 days.There is no washout between products.
117099|NCT01707043|P1|Participant Flow|Taclonex Scalp Suspension First, Then Taclonex Ointment|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.
Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products."
117100|NCT01707043|O2|Outcome|Taclonex Ointment First, Then Taclonex Scalp Suspension|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily to affected areas of psoriasis for three days.
Subjects will then cross over to use Taclonex Suspension for 3 days. There is no washout between products."
117101|NCT01707043|O1|Outcome|Taclonex Scalp Suspension First Then Taclonex Ointment|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.
Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products."
117102|NCT01707043|O2|Outcome|Taclonex Ointment First, Then Taclonex Scalp Suspension|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily to affected areas of psoriasis for three days.
Subjects will then cross over to use Taclonex Suspension for 3 days. There is no washout between products."
117140|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117103|NCT01707043|O1|Outcome|Taclonex Scalp Suspension First Then Taclonex Ointment|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.
Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products."
117104|NCT01707043|E2|Reported Event|Taclonex Scalp Suspension|"All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days.
In this arm, subjects will give a preference rating for the Suspension"
117105|NCT01707043|E1|Reported Event|Taclonex Ointment|All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas In this arm, subject will give a preference rating for Taclonex Ointment
117106|NCT01706952|B1|Baseline|Cocaine/Adrenaline|"Three cotton neuropatties will be placed in each nostril. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.
Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
117107|NCT01706952|P1|Participant Flow|Cocaine/Adrenaline|"Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).
Three cotton neuropatties will be placed in each side of the nostril. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose."
117108|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.
Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
117109|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.
Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
119452|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
117110|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.
Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
117111|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.
Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
117112|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.
Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
117113|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.
Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
117114|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.
Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
117141|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117115|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.
Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
117116|NCT01706952|E2|Reported Event|Adrenaline|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.
Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
117117|NCT01706952|E1|Reported Event|Cocaine|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.
This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.
Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
117118|NCT01706926|B5|Baseline|Total|Total of all reporting groups
117119|NCT01706926|B4|Baseline|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117120|NCT01706926|B3|Baseline|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117121|NCT01706926|B2|Baseline|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117122|NCT01706926|B1|Baseline|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117123|NCT01706926|P4|Participant Flow|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117124|NCT01706926|P3|Participant Flow|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117125|NCT01706926|P2|Participant Flow|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117613|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117126|NCT01706926|P1|Participant Flow|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117127|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117128|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117129|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117130|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117131|NCT01706926|O3|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117132|NCT01706926|O2|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117133|NCT01706926|O1|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117134|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117135|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117136|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117137|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117138|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117271|NCT01706666|E1|Reported Event|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117142|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117143|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117144|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117145|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117146|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117147|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117148|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117149|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117150|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117151|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117152|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117153|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117154|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117155|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117156|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117157|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117158|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117159|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117160|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117161|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117162|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117163|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117164|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117165|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117166|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117167|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117168|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117169|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117170|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117171|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117172|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117173|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117174|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117175|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117176|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117177|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117178|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117179|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117180|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117181|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117182|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117183|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117184|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117185|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117186|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117187|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117188|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117189|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117190|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117191|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117192|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117193|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117194|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117195|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117196|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117197|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117198|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117199|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117200|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117201|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117202|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117203|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117204|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117205|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117206|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117207|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117208|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117209|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117210|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117211|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117212|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117213|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117214|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117215|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117216|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117217|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117218|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117219|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117220|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117221|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117222|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117223|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117224|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117225|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117226|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117227|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117228|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117229|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117230|NCT01706926|E4|Reported Event|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117231|NCT01706926|E3|Reported Event|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117232|NCT01706926|E2|Reported Event|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
117233|NCT01706926|E1|Reported Event|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
117234|NCT01706822|B1|Baseline|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy
117235|NCT01706822|P1|Participant Flow|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
117236|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
117237|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
117238|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
117239|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
117240|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
117241|NCT01706822|E1|Reported Event|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy
117242|NCT01706770|B3|Baseline|Total|Total of all reporting groups
117243|NCT01706770|B2|Baseline|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
117244|NCT01706770|B1|Baseline|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
117245|NCT01706770|P2|Participant Flow|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
117246|NCT01706770|P1|Participant Flow|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
117247|NCT01706770|O2|Outcome|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
117248|NCT01706770|O1|Outcome|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
117249|NCT01706770|O2|Outcome|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
117250|NCT01706770|O1|Outcome|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
117251|NCT01706770|E2|Reported Event|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
117252|NCT01706770|E1|Reported Event|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
117253|NCT01706666|B4|Baseline|Total|Total of all reporting groups
117254|NCT01706666|B3|Baseline|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
117255|NCT01706666|B2|Baseline|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117256|NCT01706666|B1|Baseline|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117257|NCT01706666|P3|Participant Flow|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
117258|NCT01706666|P2|Participant Flow|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117259|NCT01706666|P1|Participant Flow|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117260|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
117261|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117262|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117263|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
117264|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117265|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117266|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
117267|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117268|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117269|NCT01706666|E3|Reported Event|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
117270|NCT01706666|E2|Reported Event|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
117272|NCT01706588|B6|Baseline|Total|Total of all reporting groups
117274|NCT01706588|B4|Baseline|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117275|NCT01706588|B3|Baseline|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117276|NCT01706588|B2|Baseline|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117277|NCT01706588|B1|Baseline|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117278|NCT01706588|P5|Participant Flow|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117279|NCT01706588|P4|Participant Flow|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117280|NCT01706588|P3|Participant Flow|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117281|NCT01706588|P2|Participant Flow|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117282|NCT01706588|P1|Participant Flow|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117283|NCT01706588|O5|Outcome|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117284|NCT01706588|O4|Outcome|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117285|NCT01706588|O3|Outcome|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117286|NCT01706588|O2|Outcome|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117287|NCT01706588|O1|Outcome|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117288|NCT01706588|E5|Reported Event|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117289|NCT01706588|E4|Reported Event|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117290|NCT01706588|E3|Reported Event|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117291|NCT01706588|E2|Reported Event|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117292|NCT01706588|E1|Reported Event|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
117293|NCT01706575|B1|Baseline|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
117294|NCT01706575|P1|Participant Flow|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
117295|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
117296|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
117297|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
117298|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
117299|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
117300|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
117301|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
117791|NCT01704404|O7|Outcome|Placebo|"Placebo
Placebo"
117302|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
117303|NCT01706575|E1|Reported Event|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
117304|NCT01706549|B1|Baseline|Postoperative Pain|Observational study on posthysterectomy pain
117305|NCT01706549|P1|Participant Flow|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
117306|NCT01706549|O1|Outcome|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
117307|NCT01706549|O1|Outcome|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
117308|NCT01706549|E1|Reported Event|Posthysterectomy Pain|This was an observational study, thus no adverse events were collected.
117309|NCT01706328|B3|Baseline|Total|Total of all reporting groups
117310|NCT01706328|B2|Baseline|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
117311|NCT01706328|B1|Baseline|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
117312|NCT01706328|P3|Participant Flow|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
117355|NCT01706159|P2|Participant Flow|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
119453|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
117313|NCT01706328|P2|Participant Flow|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
117314|NCT01706328|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo twice a day (one inhalation from a multi-dose powder inhaler [MPI] and one inhalation from a dry powder inhaler [DPI] in the morning; one inhalation from an MPI in the evening). In addition, all participants received supplemental albuterol (salbutamol) (via a metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
117315|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
117316|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
117317|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
117318|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
117319|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
117320|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
117321|NCT01706328|E2|Reported Event|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
117397|NCT01705652|O2|Outcome|Surgery Group|Nexrutine by mouth three times per day prior to surgery for a minimum of 30 days and maximum of 80 days. The final dose is taken the day before surgery.
117792|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg
TD-4208"
117322|NCT01706328|E1|Reported Event|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
117323|NCT01706250|B1|Baseline|MAXCLARITY II + PROACTIV|This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion.
117324|NCT01706250|P1|Participant Flow|MAXCLARITY II + PROACTIV|This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion.
117325|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117326|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117356|NCT01706159|P1|Participant Flow|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
117614|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
119454|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
117327|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117328|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117329|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117330|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117331|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117332|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117333|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117650|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117334|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117335|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117336|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117337|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117338|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117339|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wk, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117357|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
117340|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-weeks (Wk). The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117341|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117342|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117343|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117344|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117345|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117346|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117347|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wk, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117348|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wk. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117349|NCT01706250|O2|Outcome|PROACTIV|Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wk, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
117350|NCT01706250|O1|Outcome|MAXCLARITY II|MAXCLARITY II (2.5% benzyl peroxide [BPO]) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (the side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
117351|NCT01706250|E1|Reported Event|MAXCLARITY II + PROACTIV|This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion.
117352|NCT01706159|B3|Baseline|Total|Total of all reporting groups
117353|NCT01706159|B2|Baseline|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
117354|NCT01706159|B1|Baseline|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
117358|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
117359|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
117360|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
117361|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
117362|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
117363|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
117364|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
117365|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
117366|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
117367|NCT01706159|E2|Reported Event|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
117368|NCT01706159|E1|Reported Event|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
117369|NCT01706146|B1|Baseline|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
117370|NCT01706146|P1|Participant Flow|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
117371|NCT01706146|O1|Outcome|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
117372|NCT01706146|O1|Outcome|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
117373|NCT01706146|E1|Reported Event|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
117374|NCT01705717|B3|Baseline|Total|Total of all reporting groups
117375|NCT01705717|B2|Baseline|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117376|NCT01705717|B1|Baseline|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117377|NCT01705717|P2|Participant Flow|Hepatitis C Virus (HCV) – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117378|NCT01705717|P1|Participant Flow|Non-Cirrhotic Chronic Hepatitis C (CHC) Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117379|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117380|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117381|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117382|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117615|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117383|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117384|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117385|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117386|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117387|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117388|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117389|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117390|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117391|NCT01705717|E1|Reported Event|All Participants|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC or HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
117392|NCT01705652|B3|Baseline|Total|Total of all reporting groups
117393|NCT01705652|B2|Baseline|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment. Minimum of 30 days and maximum of 60 days prior to the start of radiation therapy and then during treatment. The final dose is taken the last day of radiation.
117394|NCT01705652|B1|Baseline|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery. Minimum of 30 days and maximum of 80 days before surgery. The final dose is taken the day before surgery.
117395|NCT01705652|P2|Participant Flow|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
117396|NCT01705652|P1|Participant Flow|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
117398|NCT01705652|O1|Outcome|Radiation Group|Nexrutine by mouth three times per day for a minimum of 30 days and a maximum of 60 days prior to the start of radiation therapy and during treatment. The final dose will be taken the last day of radiation.
117399|NCT01705652|E2|Reported Event|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
117400|NCT01705652|E1|Reported Event|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
117401|NCT01705574|B3|Baseline|Total|Total of all reporting groups
117402|NCT01705574|B2|Baseline|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
117403|NCT01705574|B1|Baseline|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
117404|NCT01705574|P2|Participant Flow|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (Truvada®; 200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
117405|NCT01705574|P1|Participant Flow|E/C/F/TDF|Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) (150/150/200/300 mg) fixed-dose combination (FDC) + atazanavir (ATV) placebo + ritonavir (RTV) placebo + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily for 48 weeks
117406|NCT01705574|O2|Outcome|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
117407|NCT01705574|O1|Outcome|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
117408|NCT01705574|O2|Outcome|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
117409|NCT01705574|O1|Outcome|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
117410|NCT01705574|E2|Reported Event|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
117411|NCT01705574|E1|Reported Event|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
117412|NCT01705496|B1|Baseline|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
117436|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117413|NCT01705496|P1|Participant Flow|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
117414|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
117415|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
117416|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
117417|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
117418|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
117419|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
117420|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
117421|NCT01705496|E1|Reported Event|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
117422|NCT01705145|B1|Baseline|Ivacaftor|"Part A: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
Part B: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants."
117453|NCT01704976|P2|Participant Flow|Sham|"T0- Intervention 4 weeks- T1
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
117651|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117423|NCT01705145|P1|Participant Flow|Ivacaftor|"Part A: Ivacaftor 50 milligram (mg) (for participants weighing less than [<] 14 kilograms [kg]) or 75 mg (for participants weighing greater than or equal to [>=] 14 kg) every 12 hours (q12h) from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
Part B: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants."
117424|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117425|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117426|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117427|NCT01705145|O1|Outcome|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
117428|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117429|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117430|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117431|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117432|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117433|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117434|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117435|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
119455|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
117437|NCT01705145|O1|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117438|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117439|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117440|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117441|NCT01705145|O3|Outcome|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
117442|NCT01705145|O2|Outcome|Part A: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
117443|NCT01705145|O1|Outcome|Part A: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
117444|NCT01705145|E6|Reported Event|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117445|NCT01705145|E5|Reported Event|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117446|NCT01705145|E4|Reported Event|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
117447|NCT01705145|E3|Reported Event|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
117448|NCT01705145|E2|Reported Event|Part A: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
117449|NCT01705145|E1|Reported Event|Part A: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
117450|NCT01704976|B3|Baseline|Total|Total of all reporting groups
117451|NCT01704976|B2|Baseline|Sham|"T0- Intervention 4 weeks- T1
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
117452|NCT01704976|B1|Baseline|Intervention|"T0 - intervention 4 weeks - T1
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
117523|NCT01704755|B3|Baseline|Total|Total of all reporting groups
117454|NCT01704976|P1|Participant Flow|Intervention|"T0 - intervention 4 weeks - T1
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
117455|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
117456|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
117457|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
117458|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
117459|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
117460|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
117461|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
117462|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
117463|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
117464|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
117465|NCT01704976|E2|Reported Event|Sham|"T0- Intervention 4 weeks- T1
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
117466|NCT01704976|E1|Reported Event|Intervention|"T0 - intervention 4 weeks - T1
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
117467|NCT01704846|B3|Baseline|Total|Total of all reporting groups
117537|NCT01704755|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
117538|NCT01704651|B3|Baseline|Total|Total of all reporting groups
117468|NCT01704846|B2|Baseline|Treatment Sequence 2|"Treatment sequence: Reference - Test - Test - Reference
Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.
Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.
Treatments were separated by a washout period of at least 14 days."
117469|NCT01704846|B1|Baseline|Treatment Sequence 1|"Treatment sequence: Test - Reference - Reference - Test
Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.
Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.
Treatments were separated by a washout period of at least 14 days."
117470|NCT01704846|P2|Participant Flow|Treatment Sequence 2|"Treatment sequence: Reference - Test - Test - Reference
Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.
Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.
Treatments were separated by a washout period of at least 14 days."
117471|NCT01704846|P1|Participant Flow|Treatment Sequence 1|"Treatment sequence: Test - Reference - Reference - Test
Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.
Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.
Treatments were separated by a washout period of at least 14 days."
117472|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117473|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117474|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117475|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117476|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117477|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117478|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117479|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117480|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117481|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117482|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117483|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117484|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117485|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117486|NCT01704846|E2|Reported Event|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117487|NCT01704846|E1|Reported Event|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
117488|NCT01704781|B6|Baseline|Total|Total of all reporting groups
117489|NCT01704781|B5|Baseline|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.
Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117490|NCT01704781|B4|Baseline|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.
Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117491|NCT01704781|B3|Baseline|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
117492|NCT01704781|B2|Baseline|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
117493|NCT01704781|B1|Baseline|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
117539|NCT01704651|B2|Baseline|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
117540|NCT01704651|B1|Baseline|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
120069|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
117494|NCT01704781|P5|Participant Flow|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.
Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117495|NCT01704781|P4|Participant Flow|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.
Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117496|NCT01704781|P3|Participant Flow|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
117497|NCT01704781|P2|Participant Flow|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
117498|NCT01704781|P1|Participant Flow|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
117499|NCT01704781|O5|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.
Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117500|NCT01704781|O4|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.
Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117501|NCT01704781|O3|Outcome|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
117502|NCT01704781|O2|Outcome|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
117503|NCT01704781|O1|Outcome|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
117524|NCT01704755|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
117652|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117653|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117504|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.
Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117505|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.
Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117506|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.
Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117507|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.
Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117508|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.
Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117509|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.
Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117510|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.
Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117511|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.
Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117512|NCT01704781|O3|Outcome|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
117513|NCT01704781|O2|Outcome|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
117514|NCT01704781|O1|Outcome|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
117515|NCT01704781|O3|Outcome|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
117516|NCT01704781|O2|Outcome|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
117517|NCT01704781|O1|Outcome|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
117518|NCT01704781|E5|Reported Event|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.
Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117519|NCT01704781|E4|Reported Event|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.
Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A
Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
117520|NCT01704781|E3|Reported Event|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
117521|NCT01704781|E2|Reported Event|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
117522|NCT01704781|E1|Reported Event|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
117525|NCT01704755|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
117526|NCT01704755|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
117527|NCT01704755|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
117528|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
117529|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
117530|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
117531|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
117532|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
117533|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
117534|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
117535|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
117536|NCT01704755|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
117541|NCT01704651|P2|Participant Flow|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
117616|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117542|NCT01704651|P1|Participant Flow|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
117543|NCT01704651|O2|Outcome|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
117544|NCT01704651|O1|Outcome|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
117545|NCT01704651|O2|Outcome|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
117546|NCT01704651|O1|Outcome|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
117547|NCT01704651|E2|Reported Event|Placebo|Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..
117548|NCT01704651|E1|Reported Event|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
117549|NCT01704599|B1|Baseline|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins
The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.
Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
117550|NCT01704599|P1|Participant Flow|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins
The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this, therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.
Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
117551|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins
The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks (week 28)."
117552|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins
The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this, therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject."
117576|NCT01704521|B3|Baseline|Total|Total of all reporting groups
117654|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117553|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins
The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks."
117554|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins
The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue. Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.
Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
117555|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults ages 18-65 with moderate to severe plaque psoriasis with PASI measured week 0 on no systemic psoriasis medication, weeks 4 and 16 after 4 and 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab and 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12 ranked by calculated Body Mass Index (BMI) week 0.
117556|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis. Weight measurement were in pounds measured at Weeks 16 and 28.
117557|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults age 18-65 yearswith moderate to severe plaque psoriasis measured at week 0 of study on no systemic psoriasis medication.
117558|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Temperature measurements in adults ages 18-65 with moderate to severe plaque psoriasis at week16 on adalimuamb and week 28 temperatures on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
117559|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Subjects were adults with moderate to severe plaque psoriasis with test to be measured week 0 on no systemic psoriasis medication, week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of vitamin B12.
117560|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|One adult psoriasis subject age 23 with moderate to severe plaque psoriasis with pregnanacy test on enrollment on no systemic psoriasis therapy.
117561|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults ages18-65 with moderate to severe plaque psoriasis tested at week 0 on no systemic psoriasis therapy; week 16 after 16 weeks of adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12.
117562|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis measured at 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab and daily 5 mg folic acid 100 mg vitamin B6 and 1000 mcg B12.
117563|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults 18-65 years with moderate to severe plaque psoriasis measured at week 16 after 16 weeks adalimumab and week 28 after 28 weeks adalimumab annd 12 weeks on adalimumab, folic acid 5 mg, 100 mg B6 and 1000 mcg B12.
117564|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis.
117565|NCT01704599|O1|Outcome|Humira Plus 3 B Vitamins|adults 18-65 with plaque psoriasis (moderate to severe) measured at week 0 on no systemic psoriasis medication; week 16 after 16 weeks adalimumab and at 28 weeks after 16 weeks adalimumab plus 12 weeks folic acid, vitamin B6 and B12.
117566|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults 18-65 all with moderate to severe plaque psoriasis. Week 0 (on no systemic psoriasis medication), Week 16 ( 16 weeks adalimumab), Week 28 ( 16 weeks on adalimumab plus 12 weeks on adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12 daily.
117567|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adult 18-65 year old moderate to severe plaque psoriasis patients with levels measured weeks 0,16 and 28 in 4 subjects; weeks 0 and 16 in one subject, weeks 16 and 28 in one subject and week 0 only in 2 subjects.
117568|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adult subjects ages 18-65 with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication ,week 16 after 16 wqeeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus folic acid 5 mg. vitamin B6 100 mg and vitamin B12 1000 mcg daily assessing CBC with diferential for increase, decrease and no change.
117569|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis with subject serum levels to be measured weeks 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab and then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of vitamin B12.
117570|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication; week 16 on adalimumab for 16 weeks and then week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
117571|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adult 18-65 year old adults with moderate to severe plaque psoriasis with adverse event documented sometime during the 28 week study plus telephone call day 70 post week 28 visit either with knowledge of serious event of adverse event documented from data taken weeks 4 and 16 on adalimumab alone and week 28 after 16 weeks on adalimumab plus 12 weeks on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12 and a telephone call day 70 post week 28 study visit and a telephone call day 70 post week 28 visit.
117572|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis evaluated at after week 16 of study on or after of adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and vitamin B12 or during the 10 weeks after that.
117573|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis evaluated at week 0 on no systemic psoriasis medication; weeks 16 after 16 weeks adalimumab and 28 after 16 weeks adalimumab then 12 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
117574|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
117575|NCT01704599|E1|Reported Event|Humira Then Humira Plus 3 B Vitamins|Pneumonia while on adaimumab and before the adalimumab plus B vitamins were begun.prior to vitamins
117577|NCT01704521|B2|Baseline|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin.
117578|NCT01704521|B1|Baseline|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin.
117579|NCT01704521|P2|Participant Flow|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
117580|NCT01704521|P1|Participant Flow|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
117581|NCT01704521|O2|Outcome|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration PegInterferon + Ribavirin
117582|NCT01704521|O1|Outcome|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
117583|NCT01704521|E2|Reported Event|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
117584|NCT01704521|E1|Reported Event|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
117585|NCT01704495|B5|Baseline|Total|Total of all reporting groups
117586|NCT01704495|B4|Baseline|Placebo|Placebo oral capsules self-administred twice daily
117587|NCT01704495|B3|Baseline|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117588|NCT01704495|B2|Baseline|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117589|NCT01704495|B1|Baseline|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117590|NCT01704495|P4|Participant Flow|Placebo|Placebo oral capsules self-administred twice daily
117591|NCT01704495|P3|Participant Flow|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117592|NCT01704495|P2|Participant Flow|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117593|NCT01704495|P1|Participant Flow|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117594|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117595|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117596|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117597|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117598|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117599|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117617|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117618|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117619|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117620|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117621|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117622|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117623|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117624|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117625|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117626|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117627|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117628|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117629|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117630|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117631|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117632|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117633|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117634|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117635|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117636|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117637|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117638|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117639|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117640|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117641|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117642|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117643|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117644|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117645|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117646|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117647|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117655|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117656|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117657|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117658|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117659|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117660|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117661|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117662|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117663|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117664|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117665|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117666|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117667|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117668|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117669|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117670|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117671|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117672|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117673|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117674|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117675|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117676|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117677|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117678|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117679|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117680|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
120070|NCT01694108|O2|Outcome|Control Children|No intervention
117681|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117682|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117683|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117684|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117685|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117686|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117687|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117688|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117689|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117690|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117691|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117692|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117693|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117694|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117695|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117696|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117697|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117698|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117699|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117700|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117701|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117702|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117703|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117704|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117705|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117706|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117707|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117708|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117709|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117710|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117711|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117712|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117713|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117714|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117715|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117716|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117717|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117718|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117719|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117720|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117721|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117722|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117723|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117724|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117725|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117726|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117727|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117728|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117729|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117730|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117731|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117732|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117733|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117734|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117735|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117736|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117737|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117738|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117739|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117740|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117741|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117742|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117743|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117744|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
120071|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
117745|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117746|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117747|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117748|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117749|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117750|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117751|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117752|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117753|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117754|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117755|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117756|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117757|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117758|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
117759|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117760|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117761|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117762|NCT01704495|E4|Reported Event|Placebo|Placebo oral capsules self-administered twice daily
117763|NCT01704495|E3|Reported Event|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
117764|NCT01704495|E2|Reported Event|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
117765|NCT01704495|E1|Reported Event|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
117766|NCT01704404|B1|Baseline|Entire Study Population|"All subjects received Placebo and 4 of 6 TD-4208 dose levels:
TD-4208 - 22 µg TD-4208 - 44 µg TD-4208 - 88 µg TD-4208 - 175 µg TD-4208 - 350 µg TD-4208 - 700 µg"
117767|NCT01704404|P6|Participant Flow|Treatment 6|Placebo, 44 µg, 88 µg, 175 µg, 350 µg
117768|NCT01704404|P5|Participant Flow|Treatment 5|22 µg, 44 µg, 175 µg, 350 µg
117769|NCT01704404|P4|Participant Flow|Treatment 4|22 µg, 44 µg, 175 µg, 700 µg
117770|NCT01704404|P3|Participant Flow|Treatment 3|Placebo, 22 µg, 88 µg, 175 µg, 700 µg
117771|NCT01704404|P2|Participant Flow|Treatment 2|Placebo, 22 µg, 88 µg, 350 µg, 700 µg
117772|NCT01704404|P1|Participant Flow|Treatment 1|Placebo, 44 µg, 88 µg, 350 µg, 700 µg
117773|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg
TD-4208"
117774|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg
TD-4208"
117775|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg
TD-4208"
117776|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg
TD-4208"
117777|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg
TD-4208"
117778|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg
TD-4208"
117779|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg
TD-4208"
117780|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg
TD-4208"
117781|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg
TD-4208"
117782|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg
TD-4208"
117783|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg
TD-4208"
117784|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg
TD-4208"
117793|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg
TD-4208"
117794|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg
TD-4208"
117795|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg
TD-4208"
117796|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg
TD-4208"
117797|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg
TD-4208"
117798|NCT01704404|E7|Reported Event|Placebo|"Placebo
Placebo"
117799|NCT01704404|E6|Reported Event|Dose 6 TD-4208|"700 µg
TD-4208"
117800|NCT01704404|E5|Reported Event|Dose 5 TD-4208|"350 µg
TD-4208"
117801|NCT01704404|E4|Reported Event|Dose 4 TD-4208|"175 µg
TD-4208"
117802|NCT01704404|E3|Reported Event|Dose 3 TD-4208|"88 µg
TD-4208"
117803|NCT01704404|E2|Reported Event|Dose 2 TD-4208|"44 µg
TD-4208"
117804|NCT01704404|E1|Reported Event|Dose 1 TD-4208|"22 µg
TD-4208"
117805|NCT01704287|B4|Baseline|Total|Total of all reporting groups
117806|NCT01704287|B3|Baseline|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
117807|NCT01704287|B2|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
117808|NCT01704287|B1|Baseline|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
117809|NCT01704287|P5|Participant Flow|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
117943|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
118026|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
117810|NCT01704287|P4|Participant Flow|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed progressive disease (PD) and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
117811|NCT01704287|P3|Participant Flow|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
117812|NCT01704287|P2|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
117813|NCT01704287|P1|Participant Flow|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg intravenously (IV) every 3 weeks (Q3W).
117814|NCT01704287|O5|Outcome|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
117815|NCT01704287|O4|Outcome|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
117816|NCT01704287|O3|Outcome|ICC Only|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date.
117817|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
117818|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
117819|NCT01704287|O5|Outcome|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
117820|NCT01704287|O4|Outcome|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
117821|NCT01704287|O3|Outcome|ICC Only|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date.
117822|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
117823|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
117824|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
117825|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
117826|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
117851|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117827|NCT01704287|O2|Outcome|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
117828|NCT01704287|O1|Outcome|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
117829|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
117830|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
117831|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
117832|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
117833|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
117834|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
117835|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
117836|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
117837|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
117944|NCT01703858|E6|Reported Event|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
120072|NCT01694108|O2|Outcome|Control Children|No intervention
117838|NCT01704287|E7|Reported Event|ICC (After Switch to Pembrolizumab 10 mg/kg)|Participants initially received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide), experienced confirmed PD, met all crossover criteria at study treatment Week 12, and switched to receive pembrolizumab 10 mg/kg. These events occurred while these participants were receiving pembrolizumab 10 mg/kg after switching from ICC.
117839|NCT01704287|E6|Reported Event|ICC (After Switch to Pembrolizumab 2 mg/kg)|Participants initially received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide), experienced confirmed PD, met all crossover criteria at study treatment Week 12, and switched to receive pembrolizumab 2 mg/kg. These events occurred while these participants were receiving pembrolizumab 2 mg/kg after switching from ICC.
117840|NCT01704287|E5|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
117841|NCT01704287|E4|Reported Event|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
117842|NCT01704287|E3|Reported Event|ICC (Before Switch to Pembrolizumab 10 mg/kg)|Participants received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 10 mg/kg. These events occurred while these participants were receiving ICC prior to switching.
117843|NCT01704287|E2|Reported Event|ICC (Before Switch to Pembrolizumab 2 mg/kg)|Participants received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg. These events occurred while these participants were receiving ICC prior to switching.
117844|NCT01704287|E1|Reported Event|ICC Only|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date.
117845|NCT01704261|B3|Baseline|Total|Total of all reporting groups
117846|NCT01704261|B2|Baseline|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117847|NCT01704261|B1|Baseline|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117848|NCT01704261|P2|Participant Flow|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117849|NCT01704261|P1|Participant Flow|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117850|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117911|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
117912|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
119195|NCT01698554|B5|Baseline|Total|Total of all reporting groups
117852|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117853|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117854|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117855|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117856|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117857|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117858|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117946|NCT01703858|E4|Reported Event|Pantoprazole 40mg|Participants received single dose of Pantoprazole 40mg alone twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
117859|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117860|NCT01704261|E2|Reported Event|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117861|NCT01704261|E1|Reported Event|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
117862|NCT01704196|B3|Baseline|Total|Total of all reporting groups
117863|NCT01704196|B2|Baseline|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo"
117864|NCT01704196|B1|Baseline|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
117865|NCT01704196|P2|Participant Flow|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo"
117866|NCT01704196|P1|Participant Flow|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
117867|NCT01704196|O2|Outcome|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo"
117868|NCT01704196|O1|Outcome|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
117869|NCT01704196|O2|Outcome|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo"
117870|NCT01704196|O1|Outcome|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
117871|NCT01704196|E2|Reported Event|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo"
117872|NCT01704196|E1|Reported Event|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
117873|NCT01704079|B3|Baseline|Total|Total of all reporting groups
117874|NCT01704079|B2|Baseline|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117875|NCT01704079|B1|Baseline|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117876|NCT01704079|P2|Participant Flow|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117877|NCT01704079|P1|Participant Flow|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117878|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117879|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117880|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117881|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117882|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117883|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117884|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117885|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117886|NCT01704079|E2|Reported Event|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117887|NCT01704079|E1|Reported Event|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
117888|NCT01703988|B5|Baseline|Total|Total of all reporting groups
117889|NCT01703988|B4|Baseline|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
117890|NCT01703988|B3|Baseline|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
117891|NCT01703988|B2|Baseline|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
117892|NCT01703988|B1|Baseline|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
117893|NCT01703988|P4|Participant Flow|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
117894|NCT01703988|P3|Participant Flow|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
117895|NCT01703988|P2|Participant Flow|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
117896|NCT01703988|P1|Participant Flow|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, intrathecal (IT) injection
117897|NCT01703988|O1|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
117898|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
117899|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
117900|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
117901|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
117902|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
117903|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
117904|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
117905|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
117906|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
117907|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
117908|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
117909|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
117910|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
117913|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
117914|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
117915|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
117916|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
117917|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
117918|NCT01703988|E4|Reported Event|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
117919|NCT01703988|E3|Reported Event|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
117920|NCT01703988|E2|Reported Event|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
117921|NCT01703988|E1|Reported Event|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
117922|NCT01703858|B4|Baseline|Total|Total of all reporting groups
117923|NCT01703858|B3|Baseline|C - B - A - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
117945|NCT01703858|E5|Reported Event|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
117947|NCT01703858|E3|Reported Event|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
117924|NCT01703858|B2|Baseline|B - A - C - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
117925|NCT01703858|B1|Baseline|A - C - B - D - E|Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
117926|NCT01703858|P3|Participant Flow|C - B - A - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
117927|NCT01703858|P2|Participant Flow|B - A - C - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
117928|NCT01703858|P1|Participant Flow|A - C - B - D - E|Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
117929|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
117930|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
118096|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
117931|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
117932|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
117933|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
117934|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
117935|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
117936|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
117937|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
117938|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
117939|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
117940|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
117941|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
117942|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
117948|NCT01703858|E2|Reported Event|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
117949|NCT01703858|E1|Reported Event|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
117950|NCT01703845|B3|Baseline|Total|Total of all reporting groups
117951|NCT01703845|B2|Baseline|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117952|NCT01703845|B1|Baseline|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117953|NCT01703845|P2|Participant Flow|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117954|NCT01703845|P1|Participant Flow|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117955|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117956|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117957|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117958|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117959|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117960|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117961|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117962|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117963|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117964|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117965|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
118099|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
117966|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117967|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117968|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117969|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117970|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117971|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117972|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117973|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117974|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
120073|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
117975|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117976|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117977|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117978|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117979|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117980|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117981|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117982|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117983|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117984|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117985|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117986|NCT01703845|E2|Reported Event|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117987|NCT01703845|E1|Reported Event|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
117988|NCT01703832|B3|Baseline|Total|Total of all reporting groups
117989|NCT01703832|B2|Baseline|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
117990|NCT01703832|B1|Baseline|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118097|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
118100|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
117991|NCT01703832|P2|Participant Flow|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
117992|NCT01703832|P1|Participant Flow|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
117993|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
117994|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
117995|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
117996|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
117997|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
117998|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
117999|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
118000|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118001|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
118002|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118003|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
118004|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118005|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
118006|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118007|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
118008|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118009|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
118010|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118011|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
118012|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118013|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
118014|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118015|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
118016|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118017|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
118018|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118019|NCT01703832|E2|Reported Event|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
118020|NCT01703832|E1|Reported Event|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
118021|NCT01703819|B3|Baseline|Total|Total of all reporting groups
118022|NCT01703819|B2|Baseline|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118023|NCT01703819|B1|Baseline|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to
-30 minutes
Neurexan®"
118024|NCT01703819|P2|Participant Flow|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118025|NCT01703819|P1|Participant Flow|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118027|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118028|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118029|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118030|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118031|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118032|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118033|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118034|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118035|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118036|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118037|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118038|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118039|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118040|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118041|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118042|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118043|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118044|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118045|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118046|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118047|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118048|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118049|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118050|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118051|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118052|NCT01703819|E2|Reported Event|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo"
118053|NCT01703819|E1|Reported Event|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®"
118054|NCT01703702|B3|Baseline|Total|Total of all reporting groups
118055|NCT01703702|B2|Baseline|Control|"Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
118098|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
119329|NCT01697696|E2|Reported Event|QAB149|75 μg once-daily
118056|NCT01703702|B1|Baseline|Intervention|"Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
118057|NCT01703702|P2|Participant Flow|Control|"Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
118058|NCT01703702|P1|Participant Flow|Intervention|"Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
118059|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
118060|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
118061|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
118062|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
118063|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
118064|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
118065|NCT01703702|O2|Outcome|Control Scan/Diagnosis Concordant|Control arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
118066|NCT01703702|O1|Outcome|Intervention Scan/Diagnosis Concordant|Intervention arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
118067|NCT01703702|O2|Outcome|Control Scan/Diagnosis Discordant|Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their initial diagnosis
118068|NCT01703702|O1|Outcome|Intervention Scan/Diagnosis Discordant|Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their baseline clinical diagnosis.
118069|NCT01703702|O2|Outcome|Mild Impairment AB-|Patients diagnosed with a cognitive status of mild impairment and AB- scan result.
118070|NCT01703702|O1|Outcome|Mild Impairment AB+|Patients diagnosed with a cognitive status of mild impairment and AB+ scan result.
118071|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
118072|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
118073|NCT01703702|E1|Reported Event|Safety Population|620 patients received florbetapir (18F) and comprise the Safety Population.
118074|NCT01703663|B1|Baseline|All Participants|
118075|NCT01703663|P2|Participant Flow|Control Night First Night, EPAP Therapy Second Night|During the first night, the subject was assigned to no EPAP (control night). During the second night, the subject was assigned to wear EPAP. During both nights, sleep disordered breathing was monitored with the WatchPAT device.
118076|NCT01703663|P1|Participant Flow|EPAP Therapy First Night, Then Control Night|During the first night, the subject was assigned to wear EPAP. During the second night, the subject did not wear EPAP (control night). During both nights, sleep disordered breathing was monitored with the WatchPAT device.
118077|NCT01703663|O2|Outcome|Control Night|Raw data from control night (not taking into account period effect).
118078|NCT01703663|O1|Outcome|EPAP Night|Raw data from EPAP night (not taking into account period effect).
118079|NCT01703663|E2|Reported Event|Control Night|
118080|NCT01703663|E1|Reported Event|EPAP Night|
118081|NCT01703286|B1|Baseline|Total Participants|All study participants
118082|NCT01703286|P6|Participant Flow|L 5/ Pbo/ G1-4/|Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
118083|NCT01703286|P5|Participant Flow|Pbo/ L 5/ G1-4|Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
118084|NCT01703286|P4|Participant Flow|G1-4/ Pbo/ L 5|Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
118085|NCT01703286|P3|Participant Flow|G 1-4/ L 5/ Pbo|Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days
118086|NCT01703286|P2|Participant Flow|L 5/ G 1-4/ Pbo|Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days
118087|NCT01703286|P1|Participant Flow|Pbo/ G1-4/ L 5|Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
118088|NCT01703286|O6|Outcome|Rep - Placebo|Residual effect period - Placebo
118089|NCT01703286|O5|Outcome|REP - Glimepiride 1-4 mg|Residual effect period - Glimepiride 1-4 mg
118090|NCT01703286|O4|Outcome|REP - Linagliptin 5 mg|Residual effect period - Linagliptin 5 mg
118091|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
118092|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
118093|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
118094|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
118095|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
119330|NCT01697696|E1|Reported Event|NVA237|12.5 μg twice-daily
118101|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
118102|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
118103|NCT01703286|E3|Reported Event|Placebo|Placebo: matching Linagliptin or Glimepiride given once daily over 28 days
118104|NCT01703286|E2|Reported Event|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
118105|NCT01703286|E1|Reported Event|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
118106|NCT01703260|B4|Baseline|Total|Total of all reporting groups
118107|NCT01703260|B3|Baseline|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
118108|NCT01703260|B2|Baseline|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
118109|NCT01703260|B1|Baseline|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
118110|NCT01703260|P3|Participant Flow|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
118111|NCT01703260|P2|Participant Flow|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
118112|NCT01703260|P1|Participant Flow|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
118113|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
118114|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
118160|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
118115|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
118116|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
118117|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
118118|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
118119|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
118120|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
118121|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
118122|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
118123|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
118124|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
118125|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
118126|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
118127|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
118128|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
118129|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
118130|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
118131|NCT01703260|E3|Reported Event|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
118132|NCT01703260|E2|Reported Event|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
118133|NCT01703260|E1|Reported Event|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
118134|NCT01703221|B4|Baseline|Total|Total of all reporting groups
118135|NCT01703221|B3|Baseline|Placebo (Phase A) Switching to Omarigliptin (Phase B)|Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
118136|NCT01703221|B2|Baseline|Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)|Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
118137|NCT01703221|B1|Baseline|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
118138|NCT01703221|P3|Participant Flow|Placebo (Phase A) Switching to Omarigliptin (Phase B)|Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
118139|NCT01703221|P2|Participant Flow|Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)|Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
118140|NCT01703221|P1|Participant Flow|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
118141|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
118142|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
118143|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
118144|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
118145|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
118146|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
118147|NCT01703221|O3|Outcome|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
118148|NCT01703221|O2|Outcome|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
118149|NCT01703221|O1|Outcome|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
118150|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
118151|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
118152|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
118153|NCT01703221|O3|Outcome|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
118154|NCT01703221|O2|Outcome|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
118155|NCT01703221|O1|Outcome|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
118156|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
118157|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
118158|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
118159|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
120074|NCT01694108|O2|Outcome|Control Children|No intervention
118161|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
118162|NCT01703221|E6|Reported Event|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
118163|NCT01703221|E5|Reported Event|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
118164|NCT01703221|E4|Reported Event|Omarigliptin (Phase A + B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
118165|NCT01703221|E3|Reported Event|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
118166|NCT01703221|E2|Reported Event|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
118167|NCT01703221|E1|Reported Event|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
118168|NCT01703091|B3|Baseline|Total|Total of all reporting groups
118169|NCT01703091|B2|Baseline|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118170|NCT01703091|B1|Baseline|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118171|NCT01703091|P2|Participant Flow|Placebo Plus Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118172|NCT01703091|P1|Participant Flow|Ramucirumab Plus Docetaxel|Ramucirumab 10 milligrams/kilogram (mg/kg) administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 milligrams/square meter (mg/m2) administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118173|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118174|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118175|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118176|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118177|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118178|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118179|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118180|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118181|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118399|NCT01702246|O1|Outcome|Baseline Cholesterol|mean cholesterol level (mmol/L) prior to treatment with simvastatin
118182|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118183|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118184|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118185|NCT01703091|E2|Reported Event|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118186|NCT01703091|E1|Reported Event|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
118187|NCT01703000|B1|Baseline|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118188|NCT01703000|P1|Participant Flow|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118189|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118190|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118191|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118192|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118193|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118194|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118195|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118196|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118197|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118198|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118199|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118200|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118201|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118202|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118203|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118204|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118205|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118206|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118207|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118208|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118209|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118210|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118764|NCT01701011|P2|Participant Flow|Monitoring-control Group|Daily Record Keeping and Questionnaires
118211|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118212|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118213|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118214|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118215|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118216|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118217|NCT01703000|E1|Reported Event|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
118218|NCT01702987|B3|Baseline|Total|Total of all reporting groups
118219|NCT01702987|B2|Baseline|Statin + Ubiquinol|"12 patients on statins and ubiquinol
ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients
statin: statin was given for 1 month to 21 patients"
118220|NCT01702987|B1|Baseline|Statin + Placebo|"9 patients taking statin medications and placebo.
placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients
statin: statin was given for 1 month to 21 patients"
118221|NCT01702987|P2|Participant Flow|Statin + Ubiquinol|"12 patients on statins and ubiquinol
ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients
statin: statin was given for 1 month to 21 patients"
118222|NCT01702987|P1|Participant Flow|Statin + Placebo|"9 patients taking statin medications and placebo.
placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients
statin: statin was given for 1 month to 21 patients"
118223|NCT01702987|O2|Outcome|Statin + Ubiquinol|"12 patients on statins and ubiquinol
ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients
statin: statin was given for 1 month to 21 patients"
118224|NCT01702987|O1|Outcome|Statin + Placebo|"9 patients taking statin medications and placebo.
placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients
statin: statin was given for 1 month to 21 patients"
118225|NCT01702987|E2|Reported Event|Statin + Placebo|"9 patients taking statin medications and placebo.
placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients
statin: statin was given for 1 month to 21 patients"
118226|NCT01702987|E1|Reported Event|Statin + Ubiquinol|"12 patients on statins and ubiquinol
ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients
statin: statin was given for 1 month to 21 patients"
118227|NCT01702961|B1|Baseline|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells
BEAM Conditioning.
Melphalan: Given on Day -1
Melphalan is administered according to the current SOP.
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2
BCNU: BCNU 300 mg/m2 IV given on Day -6
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28
Stem Cells: Stem cells given on Day 0"
118228|NCT01702961|P1|Participant Flow|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.
Melphalan: Given on Day -1
Melphalan is administered according to the current SOP.
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2
BCNU: BCNU 300 mg/m2 IV given on Day -6
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28
Stem Cells: Stem cells given on Day 0"
118229|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.
Melphalan: Given on Day -1
Melphalan is administered according to the current SOP.
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2
BCNU: BCNU 300 mg/m2 IV given on Day -6
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28
Stem Cells: Stem cells given on Day 0"
118230|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.
Melphalan: Given on Day -1
Melphalan is administered according to the current SOP.
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2
BCNU: BCNU 300 mg/m2 IV given on Day -6
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28
Stem Cells: Stem cells given on Day 0"
118231|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.
Melphalan: Given on Day -1
Melphalan is administered according to the current SOP.
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2
BCNU: BCNU 300 mg/m2 IV given on Day -6
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28
Stem Cells: Stem cells given on Day 0"
118232|NCT01702961|E1|Reported Event|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.
BEAM Conditioning.
Melphalan: Given on Day -1
Melphalan is administered according to the current SOP.
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2
BCNU: BCNU 300 mg/m2 IV given on Day -6
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28
Stem Cells: Stem cells given on Day 0"
118233|NCT01702532|B3|Baseline|Total|Total of all reporting groups
118234|NCT01702532|B2|Baseline|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes).
118235|NCT01702532|B1|Baseline|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
118236|NCT01702532|P2|Participant Flow|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
118237|NCT01702532|P1|Participant Flow|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
118238|NCT01702532|O2|Outcome|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes).
118239|NCT01702532|O1|Outcome|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
118240|NCT01702532|O2|Outcome|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes)
118241|NCT01702532|O1|Outcome|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
118242|NCT01702532|E2|Reported Event|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
118243|NCT01702532|E1|Reported Event|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
118244|NCT01702519|B3|Baseline|Total|Total of all reporting groups
118245|NCT01702519|B2|Baseline|Reference Then Test Patch|Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
118246|NCT01702519|B1|Baseline|Test Then Reference Patch|Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
118420|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
120075|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
118247|NCT01702519|P2|Participant Flow|Reference Then Test Patch|Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
118248|NCT01702519|P1|Participant Flow|Test Then Reference Patch|Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
118249|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
118250|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
118251|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
118252|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
118253|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
118254|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
118255|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with reference adhesive, for 24 hours
118256|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours
118257|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
118258|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
118259|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
118260|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
118261|NCT01702519|E2|Reported Event|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours
118262|NCT01702519|E1|Reported Event|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
118263|NCT01702454|B3|Baseline|Total|Total of all reporting groups
118264|NCT01702454|B2|Baseline|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118265|NCT01702454|B1|Baseline|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118266|NCT01702454|P2|Participant Flow|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118267|NCT01702454|P1|Participant Flow|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118268|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|SuSubjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118269|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118270|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118271|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118272|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118273|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118274|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118275|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118276|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
120076|NCT01694108|O2|Outcome|Control Children|No intervention
118277|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118278|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118279|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118280|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118281|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118282|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118283|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118284|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118285|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118286|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118287|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm
118288|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118289|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118366|NCT01702311|E2|Reported Event|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
118290|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118291|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118292|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118293|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118294|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118295|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118296|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118297|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118298|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118299|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm
118300|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118301|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118302|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118303|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm
118304|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118305|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118306|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118307|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118308|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118309|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118310|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118311|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118312|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118313|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118314|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118315|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118316|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118317|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118318|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118319|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118320|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118321|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118322|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118323|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118324|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118325|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118326|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118327|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118328|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118329|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118330|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118331|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NC T01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118332|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118333|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118334|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118335|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118336|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118337|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118338|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118339|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118340|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118341|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118342|NCT01702454|E2|Reported Event|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118343|NCT01702454|E1|Reported Event|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
118344|NCT01702363|B1|Baseline|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118345|NCT01702363|P1|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
118346|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118347|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118348|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118349|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118350|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118351|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118352|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118353|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118354|NCT01702363|O1|Outcome|MEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118355|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118356|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118357|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118358|NCT01702363|E1|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
118359|NCT01702311|B3|Baseline|Total|Total of all reporting groups
118360|NCT01702311|B2|Baseline|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
118361|NCT01702311|B1|Baseline|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
118362|NCT01702311|P2|Participant Flow|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
118363|NCT01702311|P1|Participant Flow|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
118364|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
118365|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
118367|NCT01702311|E1|Reported Event|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
118368|NCT01702298|B1|Baseline|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
118369|NCT01702298|P1|Participant Flow|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
118370|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
118371|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
118372|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
118373|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
118374|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
118375|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
118376|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
118377|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
118378|NCT01702298|E1|Reported Event|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
118379|NCT01702259|B3|Baseline|Total|Total of all reporting groups
118380|NCT01702259|B2|Baseline|Placebo Device|"Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS."
118381|NCT01702259|B1|Baseline|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
118382|NCT01702259|P2|Participant Flow|Placebo Device|"Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS."
118383|NCT01702259|P1|Participant Flow|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light."
118384|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS."
118385|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
118386|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS."
118387|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
118388|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS."
118389|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
118390|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS."
118391|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
118392|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS."
118393|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
118394|NCT01702259|E2|Reported Event|Placebo Device|"Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS."
118395|NCT01702259|E1|Reported Event|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
118396|NCT01702246|B1|Baseline|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months
Simvastatin: 40 mg, orally, once daily for 3 months"
118397|NCT01702246|P1|Participant Flow|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months
Simvastatin: 40 mg, orally, once daily for 3 months"
118398|NCT01702246|O2|Outcome|Simvastatin Treatment|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
119331|NCT01697592|B11|Baseline|Total|Total of all reporting groups
118400|NCT01702246|O2|Outcome|Simvastatin|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
118401|NCT01702246|O1|Outcome|Baseline|prior to treatment with simvastatin
118402|NCT01702246|O2|Outcome|Simvastatin|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
118403|NCT01702246|O1|Outcome|Baseline|prior to treatment with simvastatin
118404|NCT01702246|E1|Reported Event|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months
Simvastatin: 40 mg, orally, once daily for 3 months"
118405|NCT01702233|B4|Baseline|Total|Total of all reporting groups
118406|NCT01702233|B3|Baseline|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118407|NCT01702233|B2|Baseline|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
118408|NCT01702233|B1|Baseline|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118409|NCT01702233|P3|Participant Flow|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118410|NCT01702233|P2|Participant Flow|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
118411|NCT01702233|P1|Participant Flow|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118412|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118413|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
118414|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118415|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118416|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
118417|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118418|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118419|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
120077|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
118421|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118422|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
118423|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118424|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118425|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
118426|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118427|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
118428|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118429|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
118430|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118431|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118432|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118433|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118434|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118435|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
118436|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118437|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118438|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118439|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118440|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118441|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
118442|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118443|NCT01702233|E3|Reported Event|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118444|NCT01702233|E2|Reported Event|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
118445|NCT01702233|E1|Reported Event|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
118446|NCT01702025|B5|Baseline|Total|Total of all reporting groups
118447|NCT01702025|B4|Baseline|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
118448|NCT01702025|B3|Baseline|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
118449|NCT01702025|B2|Baseline|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
118450|NCT01702025|B1|Baseline|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
118451|NCT01702025|P4|Participant Flow|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
118452|NCT01702025|P3|Participant Flow|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
118453|NCT01702025|P2|Participant Flow|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
118454|NCT01702025|P1|Participant Flow|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
118455|NCT01702025|O8|Outcome|Hypoxia Methazolamide/Aminophylline|Methazolamide combined with Aminophylline: single dose hypoxia
118456|NCT01702025|O7|Outcome|Normoxia Methazolamide/Aminophylline|Methazolamide combined with Aminophylline: single dose normoxia
118457|NCT01702025|O6|Outcome|Hypoxia Methazolamide|Methazolamide: single dose hypoxia
118458|NCT01702025|O5|Outcome|Normoxia Methazolamide|Methazolamide single dose Normoxia
118459|NCT01702025|O4|Outcome|Hypoxia Aminophylline|Aminophylline:single dose hypoxia
118460|NCT01702025|O3|Outcome|Normoxia Aminophylline|Aminophylline:single dose Normoxia
118461|NCT01702025|O2|Outcome|Hypoxia Placebo|Placebo: single dose hypoxia
118462|NCT01702025|O1|Outcome|Normoxia Placebo|Placebo: single dose Normoxia
118463|NCT01702025|E4|Reported Event|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
118464|NCT01702025|E3|Reported Event|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide Hypoxia
118465|NCT01702025|E2|Reported Event|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
118466|NCT01702025|E1|Reported Event|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo Hypoxia
118467|NCT01701999|B3|Baseline|Total|Total of all reporting groups
118468|NCT01701999|B2|Baseline|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
118469|NCT01701999|B1|Baseline|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
118470|NCT01701999|P2|Participant Flow|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
120078|NCT01694108|O2|Outcome|Control Children|No intervention
118471|NCT01701999|P1|Participant Flow|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
118472|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
118473|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
118474|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
118475|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
118476|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
118477|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
118478|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
118479|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
118480|NCT01701999|E2|Reported Event|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
118481|NCT01701999|E1|Reported Event|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
118482|NCT01701674|B1|Baseline|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
118483|NCT01701674|P1|Participant Flow|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
118484|NCT01701674|O1|Outcome|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
118485|NCT01701674|O1|Outcome|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
118486|NCT01701674|E1|Reported Event|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
118522|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118523|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118487|NCT01701622|B1|Baseline|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.
febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.
If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.
Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
118488|NCT01701622|P1|Participant Flow|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.
febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.
If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.
Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
118489|NCT01701622|O2|Outcome|Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.
febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.
If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.
Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
118490|NCT01701622|O1|Outcome|Allopurinol|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.
febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.
If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.
Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
118491|NCT01701622|E1|Reported Event|Febuxostat|Febuxostat group. The primary outcome of the study is the 24 hour ABPM differences while participants were taking allopurinol compared to taking febuxostat.
118492|NCT01701505|B7|Baseline|Total|Total of all reporting groups
118493|NCT01701505|B6|Baseline|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118494|NCT01701505|B5|Baseline|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118495|NCT01701505|B4|Baseline|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118496|NCT01701505|B3|Baseline|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
118497|NCT01701505|B2|Baseline|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118498|NCT01701505|B1|Baseline|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118499|NCT01701505|P6|Participant Flow|Cohort C: 3-6 Years Low Dose|"120uL of Kovacaine Mist, as 2 sprays of 60uL
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each"
118500|NCT01701505|P5|Participant Flow|Cohort B: 7-11 Years Med Dose|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118501|NCT01701505|P4|Participant Flow|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118502|NCT01701505|P3|Participant Flow|Cohort A: 12-17 Years HighDose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each.
118503|NCT01701505|P2|Participant Flow|Cohort A: 12-17 Years Mid-Dose (200uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each.
118504|NCT01701505|P1|Participant Flow|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each.
118505|NCT01701505|O3|Outcome|Kovacaine Mist Low Dose|"120uL of Kovacaine Mist, as 2 sprays of 60uL.
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each."
118506|NCT01701505|O2|Outcome|Kovacaine Mist Mid Dose|"200uL of Kovacaine Mist, as 2 sprays of 100uL.
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each."
118507|NCT01701505|O1|Outcome|Kovacaine Mist High Dose|"400uL of Kovacaine Mist, as 2 sprays of 200uL.
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each."
118508|NCT01701505|O3|Outcome|Kovacaine Mist Low Dose|"120uL of Kovacaine Mist, as 2 sprays of 60uL.
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each."
118509|NCT01701505|O2|Outcome|Kovacaine Mist Mid Dose|"200uL of Kovacaine Mist, as 2 sprays of 100uL.
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each."
118510|NCT01701505|O1|Outcome|Kovacaine Mist High Dose|"400uL of Kovacaine Mist, as 2 sprays of 200uL.
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each."
118511|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118512|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118513|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118514|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
118515|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118516|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118517|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118518|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118519|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118520|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
118521|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118767|NCT01701011|O2|Outcome|Monitoring-control Group|Daily Record Keeping and Questionnaires
118524|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118525|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118526|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
118527|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118528|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118529|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118530|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118531|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118532|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
118533|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118534|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118535|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118536|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118537|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118538|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
118539|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118540|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118541|NCT01701505|O6|Outcome|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118542|NCT01701505|O5|Outcome|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118543|NCT01701505|O4|Outcome|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118544|NCT01701505|O3|Outcome|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
118545|NCT01701505|O2|Outcome|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118546|NCT01701505|O1|Outcome|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118547|NCT01701505|E6|Reported Event|Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118548|NCT01701505|E5|Reported Event|Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118549|NCT01701505|E4|Reported Event|Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118550|NCT01701505|E3|Reported Event|Cohort A: 12-17 High Dose (400uL Kovacaine Mist)|400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
118551|NCT01701505|E2|Reported Event|Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)|200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
118552|NCT01701505|E1|Reported Event|Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)|120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
118553|NCT01701414|B3|Baseline|Total|Total of all reporting groups
118554|NCT01701414|B2|Baseline|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.
Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
118555|NCT01701414|B1|Baseline|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.
Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
118556|NCT01701414|P2|Participant Flow|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.
Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
118579|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118557|NCT01701414|P1|Participant Flow|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.
Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
118558|NCT01701414|O2|Outcome|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.
Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
118559|NCT01701414|O1|Outcome|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.
Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
118598|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118599|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118600|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
120079|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
118560|NCT01701414|E2|Reported Event|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.
Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
118561|NCT01701414|E1|Reported Event|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.
Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
118562|NCT01701401|B5|Baseline|Total|Total of all reporting groups
118563|NCT01701401|B4|Baseline|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118564|NCT01701401|B3|Baseline|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118565|NCT01701401|B2|Baseline|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118566|NCT01701401|B1|Baseline|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118567|NCT01701401|P4|Participant Flow|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118568|NCT01701401|P3|Participant Flow|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118569|NCT01701401|P2|Participant Flow|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118570|NCT01701401|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet once daily for 12 weeks
118571|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118572|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118573|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118574|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118575|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118576|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118577|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118578|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118580|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118581|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118582|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118583|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118584|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118585|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118586|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118587|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118588|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118589|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118590|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118591|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118592|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118593|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118594|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118595|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118596|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118597|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118601|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118602|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118603|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118604|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118605|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118606|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118607|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118608|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118609|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118610|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118611|NCT01701401|E4|Reported Event|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
118612|NCT01701401|E3|Reported Event|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
118613|NCT01701401|E2|Reported Event|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
118614|NCT01701401|E1|Reported Event|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
118615|NCT01701375|B1|Baseline|Arm 1|"PD 0332991 will be given orally days 1,2,3
Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6
Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
118616|NCT01701375|P1|Participant Flow|Arm 1|"PD 0332991 125 was given orally days 1,2,3
Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6
Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
118617|NCT01701375|O1|Outcome|Arm 1|"PD 0332991 will be given orally days 1,2,3
Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6
Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
118618|NCT01701375|E1|Reported Event|Arm 1|"PD 0332991 will be given orally days 1,2,3
Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6
Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
118619|NCT01701362|B3|Baseline|Total|Total of all reporting groups
118620|NCT01701362|B2|Baseline|Placebo|Participants randomized to receive placebo
118621|NCT01701362|B1|Baseline|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118622|NCT01701362|P2|Participant Flow|Placebo|Participants randomized to receive placebo
118765|NCT01701011|P1|Participant Flow|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
118623|NCT01701362|P1|Participant Flow|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118624|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118625|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118626|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118627|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118628|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118629|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118630|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118631|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118632|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118633|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118634|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118635|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118636|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118637|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118638|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118639|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118640|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118641|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118642|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118643|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118644|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118645|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118646|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
118647|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118648|NCT01701362|E2|Reported Event|Placebo|Participants randomized to receive placebo
118649|NCT01701362|E1|Reported Event|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
118650|NCT01701271|B1|Baseline|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
118651|NCT01701271|P1|Participant Flow|Volunteers Evaluated|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
118652|NCT01701271|O1|Outcome|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
118653|NCT01701271|O1|Outcome|Volunteers Evaluated|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
118654|NCT01701271|O1|Outcome|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
118655|NCT01701271|E1|Reported Event|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
118656|NCT01701245|B3|Baseline|Total|Total of all reporting groups
118657|NCT01701245|B2|Baseline|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation"
118658|NCT01701245|B1|Baseline|Standard of Care|No intervention, standard of care
118659|NCT01701245|P2|Participant Flow|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation"
118660|NCT01701245|P1|Participant Flow|Standard of Care|No intervention, standard of care
118661|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation"
118662|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
118663|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation"
118664|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
118665|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation"
118666|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
118667|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation"
118668|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
118669|NCT01701245|E2|Reported Event|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.
GammaCore: vagal stimulation"
118670|NCT01701245|E1|Reported Event|Standard of Care|No intervention, standard of care
118671|NCT01701102|B5|Baseline|Total|Total of all reporting groups
118672|NCT01701102|B4|Baseline|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118673|NCT01701102|B3|Baseline|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118674|NCT01701102|B2|Baseline|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118675|NCT01701102|B1|Baseline|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118676|NCT01701102|P4|Participant Flow|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 mg) and fentanyl (10 µg)
118677|NCT01701102|P3|Participant Flow|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (27 mg) and fentanyl (10 µg)
118678|NCT01701102|P2|Participant Flow|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (30 mg) and fentanyl (10 µg)
118679|NCT01701102|P1|Participant Flow|Mepivacaine 37.5 mg|Mepivacaine (37.5 mg)
118680|NCT01701102|O4|Outcome|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118681|NCT01701102|O3|Outcome|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118682|NCT01701102|O2|Outcome|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118683|NCT01701102|O1|Outcome|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118684|NCT01701102|E4|Reported Event|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118685|NCT01701102|E3|Reported Event|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118686|NCT01701102|E2|Reported Event|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118687|NCT01701102|E1|Reported Event|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
118688|NCT01701063|B4|Baseline|Total|Total of all reporting groups
118689|NCT01701063|B3|Baseline|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118690|NCT01701063|B2|Baseline|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118691|NCT01701063|B1|Baseline|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118692|NCT01701063|P3|Participant Flow|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118693|NCT01701063|P2|Participant Flow|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118705|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118766|NCT01701011|O3|Outcome|Routine Care Control Group|Patients receive only questionnaires
118694|NCT01701063|P1|Participant Flow|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 milligram per kilogram [mg/kg] of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with pegylated interferon alfa 2b (Peg-IFN-alfa-2b) 60 microgram per meter square (mcg/m^2) subcutaneous injection weekly and ribavirin (RBV) 200 mg capsules or 40 milligram per milliliter (mg/mL) solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved extended rapid virologic response (eRVR) or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) levels at Week 4 and Week 12.
118695|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118696|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118697|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118698|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118735|NCT01701037|B1|Baseline|Basic Science (Dabrafenib, Trametinib)|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.
dabrafenib: 150 mg given PO
trametinib: 2 mg given PO
laboratory biomarker analysis: Correlative studies"
120080|NCT01694108|O2|Outcome|Control Children|No intervention
118699|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118700|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118701|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118702|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118703|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118704|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118763|NCT01701011|P3|Participant Flow|Routine Care Control Group|Patients receive only questionnaires
118706|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118707|NCT01701063|O1|Outcome|Overall Participants|Participants aged 3 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 to 18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118708|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118709|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118710|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
120081|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
118711|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118712|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118713|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118714|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118715|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118716|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118717|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118718|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118719|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118720|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118721|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118722|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
119049|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
118723|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118724|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118725|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118726|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118727|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118728|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118729|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118730|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118731|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118732|NCT01701063|E3|Reported Event|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118733|NCT01701063|E2|Reported Event|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
118734|NCT01701063|E1|Reported Event|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
120082|NCT01694108|O2|Outcome|Control Children|No intervention
118736|NCT01701037|P1|Participant Flow|Basic Science (Dabrafenib, Trametinib)|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.
dabrafenib: 150 mg given PO
trametinib: 2 mg given PO
laboratory biomarker analysis: Correlative studies"
118737|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|
118738|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|
118739|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.
dabrafenib: 150 mg given PO
trametinib: 2 mg given PO
laboratory biomarker analysis: Correlative studies"
118740|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|
118741|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.
dabrafenib: 150 mg given PO
trametinib: 2 mg given PO
laboratory biomarker analysis: Correlative studies"
118742|NCT01701037|O1|Outcome|Dabrafenib and Trametinib|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.
dabrafenib: 150 mg given PO
trametinib: 2 mg given PO
laboratory biomarker analysis: Correlative studies"
118743|NCT01701037|E1|Reported Event|Basic Science (Dabrafenib, Trametinib)|"Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.
dabrafenib: 150 mg given PO
trametinib: 2 mg given PO
laboratory biomarker analysis: Correlative studies"
118744|NCT01701024|B3|Baseline|Total|Total of all reporting groups
118745|NCT01701024|B2|Baseline|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
118746|NCT01701024|B1|Baseline|ACYC|ACYC active, topically applied to the face for 12 weeks
118747|NCT01701024|P2|Participant Flow|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
118748|NCT01701024|P1|Participant Flow|ACYC|ACYC active, topically applied to the face for 12 weeks
118749|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
118750|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
118751|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
118752|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
118753|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
118754|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
118755|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
118756|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
118757|NCT01701024|E2|Reported Event|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
118758|NCT01701024|E1|Reported Event|ACYC|ACYC active, topically applied to the face for 12 weeks
118759|NCT01701011|B4|Baseline|Total|Total of all reporting groups
118760|NCT01701011|B3|Baseline|Routine Care Control Group|"Questionnaires
Coping intervention, Daily Record Keeping, Questionnaires :"
118761|NCT01701011|B2|Baseline|Monitoring-control Group|"DRK and Questionnaires
Coping intervention, Daily Record Keeping, Questionnaires :"
118762|NCT01701011|B1|Baseline|PRCI-monitoring Group|"Coping intervention, Daily Record Keeping, Questionnaires
Coping intervention, Daily Record Keeping, Questionnaires :"
118768|NCT01701011|O1|Outcome|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
118769|NCT01701011|O3|Outcome|Routine Care Control Group|patients receive questionnaires
118770|NCT01701011|O2|Outcome|Monitoring-control Group|Daily Record Keeping and Questionnaires
118771|NCT01701011|O1|Outcome|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
118772|NCT01701011|E3|Reported Event|Routine Care Control Group|patients received questionnaires
118773|NCT01701011|E2|Reported Event|Monitoring-control Group|Daily Record Keeping and Questionnaires
118774|NCT01701011|E1|Reported Event|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
118775|NCT01700907|B3|Baseline|Total|Total of all reporting groups
118776|NCT01700907|B2|Baseline|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
118777|NCT01700907|B1|Baseline|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
118778|NCT01700907|P2|Participant Flow|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
118779|NCT01700907|P1|Participant Flow|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
118780|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
118781|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
118782|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
118783|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
119050|NCT01699750|O4|Outcome|BIOTRUE With Acuvue Oasys|BIOTRUE with senofilcon A contact lenses for 30 days
118784|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
118785|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
118786|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
118787|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
118788|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
118789|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
118790|NCT01700907|E2|Reported Event|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
118791|NCT01700907|E1|Reported Event|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
118792|NCT01700816|B3|Baseline|Total|Total of all reporting groups
118793|NCT01700816|B2|Baseline|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118794|NCT01700816|B1|Baseline|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118795|NCT01700816|P2|Participant Flow|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118796|NCT01700816|P1|Participant Flow|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118797|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118798|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118799|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118800|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118801|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118802|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118803|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118804|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
121065|NCT01689207|P7|Participant Flow|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
118805|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118806|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118807|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118808|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118809|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118810|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118811|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118812|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118813|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118814|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118815|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118816|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118817|NCT01700816|O2|Outcome|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118818|NCT01700816|O1|Outcome|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118819|NCT01700816|E2|Reported Event|Sham Light|"<1000 Lux gaze directed every morning from 8 am until 8:30 am
Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am."
118820|NCT01700816|E1|Reported Event|Bright Light Therapy|"2500 Lux gaze directed every morning from 8 am until 8:30 am
Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am."
118821|NCT01699698|B3|Baseline|Total|Total of all reporting groups
118822|NCT01699698|B2|Baseline|Control|Normal cohort
118823|NCT01699698|B1|Baseline|Test Subject|UICC Stage II pancreatic ductal adenocarcinoma cohort
118824|NCT01699698|P2|Participant Flow|Control|Normal cohort
118825|NCT01699698|P1|Participant Flow|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
118826|NCT01699698|O2|Outcome|Control|Normal cohort
118827|NCT01699698|O1|Outcome|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
118828|NCT01699698|O2|Outcome|Control|Normal cohort
118829|NCT01699698|O1|Outcome|Test Subject|UICC Stage II pancreatic ductal adenocarcinoma cohort
118830|NCT01699698|E2|Reported Event|Normal|Normal cohort
118831|NCT01699698|E1|Reported Event|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
118832|NCT01700530|B4|Baseline|Total|Total of all reporting groups
118833|NCT01700530|B3|Baseline|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
118834|NCT01700530|B2|Baseline|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)
Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
118835|NCT01700530|B1|Baseline|Statin|"Statins (40mg/day)for an average of 12 weeks
Statin: Statins (40mg/day)for 12 weeks"
118836|NCT01700530|P3|Participant Flow|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
118837|NCT01700530|P2|Participant Flow|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)
Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
118838|NCT01700530|P1|Participant Flow|Statin|"Statins (40mg/day)for an average of 12 weeks
Statin: Statins (40mg/day)for 12 weeks"
118839|NCT01700530|O3|Outcome|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
118840|NCT01700530|O2|Outcome|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)
Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
118841|NCT01700530|O1|Outcome|Statin|"Statins (40mg/day)for an average of 12 weeks
Statin: Statins (40mg/day)for 12 weeks"
121066|NCT01689207|P6|Participant Flow|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
118842|NCT01700530|O3|Outcome|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
118843|NCT01700530|O2|Outcome|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)
Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
118844|NCT01700530|O1|Outcome|Statin|"Statins (40mg/day)for an average of 12 weeks
Statin: Statins (40mg/day)for 12 weeks"
118845|NCT01700530|E3|Reported Event|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
118846|NCT01700530|E2|Reported Event|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)
Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
118847|NCT01700530|E1|Reported Event|Statin|"Statins (40mg/day)for an average of 12 weeks
Statin: Statins (40mg/day)for 12 weeks"
118848|NCT01700517|B4|Baseline|Total|Total of all reporting groups
118849|NCT01700517|B3|Baseline|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.
sciatic nerves block : sciatic nerves block
Spinal anesthesia : spinal anesthesia
Femoral nerve block : Femoral nerve block"
118850|NCT01700517|B2|Baseline|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.
Spinal anesthesia : spinal anesthesia"
118851|NCT01700517|B1|Baseline|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.
Spinal anesthesia : spinal anesthesia
Femoral nerve block : Femoral nerve block"
119051|NCT01699750|O3|Outcome|BIOTRUE With Air Optix Aqua|BIOTRUE with lotrafilcon B contact lenses for 30 days
118852|NCT01700517|P3|Participant Flow|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.
sciatic nerves block : sciatic nerves block
Spinal anesthesia : spinal anesthesia
Femoral nerve block : Femoral nerve block"
118853|NCT01700517|P2|Participant Flow|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.
Spinal anesthesia : spinal anesthesia"
118854|NCT01700517|P1|Participant Flow|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.
Spinal anesthesia : spinal anesthesia
Femoral nerve block : Femoral nerve block"
118855|NCT01700517|O3|Outcome|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.
sciatic nerves block : sciatic nerves block
Spinal anesthesia : spinal anesthesia
Femoral nerve block : Femoral nerve block
To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
118856|NCT01700517|O2|Outcome|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.
Spinal anesthesia : spinal anesthesia
To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
118857|NCT01700517|O1|Outcome|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.
Spinal anesthesia : spinal anesthesia
Femoral nerve block : Femoral nerve block
To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
118858|NCT01700517|E3|Reported Event|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.
sciatic nerves block : sciatic nerves block
Spinal anesthesia : spinal anesthesia
Femoral nerve block : Femoral nerve block"
118896|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
136536|NCT01627002|P4|Participant Flow|Part A PA401 3.0 mg|
118859|NCT01700517|E2|Reported Event|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.
Spinal anesthesia : spinal anesthesia"
118860|NCT01700517|E1|Reported Event|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.
Spinal anesthesia : spinal anesthesia
Femoral nerve block : Femoral nerve block"
118861|NCT01700387|B3|Baseline|Total|Total of all reporting groups
118862|NCT01700387|B2|Baseline|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
118863|NCT01700387|B1|Baseline|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
118864|NCT01700387|P2|Participant Flow|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs (every night at bedtime) Week 2: 1 tab bid (twice daily) Week 3: 1 tab q am (every day before noon) + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
119052|NCT01699750|O2|Outcome|OFPM With Acuvue Oasys|OFPM with senofilcon A contact lenses for 30 days
118865|NCT01700387|P1|Participant Flow|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs (every night at bedtime) Week 2: topiramate 25 mg bid (twice a day) Week 3: topiramate 25 mg q am (every day before noon) + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
118866|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab q hs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs q hs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
118867|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg q hs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50mg q hs Week 4: topiramate 50mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
118868|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab q hs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs q hs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
118869|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg q hs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50mg q hs Week 4: topiramate 50mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
118870|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
119094|NCT01699373|B2|Baseline|Manual Palpation|
118871|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
118872|NCT01700387|E2|Reported Event|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
118873|NCT01700387|E1|Reported Event|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
118874|NCT01700348|B1|Baseline|All Randomized Subjects|The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.
118875|NCT01700348|P1|Participant Flow|All Enrolled Subjects|Airflosser & Manual Floss
118876|NCT01700348|O1|Outcome|All Randomized Subjects|"The study was terminated early, data were not analyzed and the plaque samples were destroyed."
118877|NCT01700348|E1|Reported Event|All Randomized Subjects|Summary of AEs for All Randomized Subjects
118878|NCT01700335|B1|Baseline|All Participants|All participants who received at least 1 dose of SyB L-1101 either at 1200 mg/day or 1800 mg/day intravenously.
119053|NCT01699750|O1|Outcome|OFPM With Air Optix Aqua|OFPM with lotrafilcon B contact lenses for 30 days
118879|NCT01700335|P2|Participant Flow|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
118880|NCT01700335|P1|Participant Flow|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
118881|NCT01700335|O1|Outcome|All Participants|All participants who received at least 1 dose of SyB L-1101 either at 1200 mg/day or 1800 mg/day intravenously.
118882|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
118883|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
118884|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
118885|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
118886|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
118887|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
118888|NCT01700335|E2|Reported Event|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
118889|NCT01700335|E1|Reported Event|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.
The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
118890|NCT01700192|B3|Baseline|Total|Total of all reporting groups
118891|NCT01700192|B2|Baseline|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
118892|NCT01700192|B1|Baseline|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
118893|NCT01700192|P2|Participant Flow|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
118894|NCT01700192|P1|Participant Flow|MK-8237|Participants took MK-8237 12 development unit (DU) rapidly dissolving tablets administered sublingually once daily (q.d.) for up to one year.
118895|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
118897|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
118898|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
118899|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
118900|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
118901|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
118902|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
118903|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
118904|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
118905|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
118906|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
118907|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
118908|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
118909|NCT01700192|E2|Reported Event|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
118910|NCT01700192|E1|Reported Event|MK-8237 12 DU|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
118911|NCT01700179|B1|Baseline|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. RBV (as per label) for Days 1-84.
ACH-0143102
Ribavirin"
118912|NCT01700179|P1|Participant Flow|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per the label) for Days 1-84.
ACH-0143102
Ribavirin"
118913|NCT01700179|O1|Outcome|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per label) for Days 1-84.
ACH-0143102
Ribavirin"
118914|NCT01700179|E1|Reported Event|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per label) for Days 1-84.
ACH-0143102
Ribavirin"
118915|NCT01700140|B4|Baseline|Total|Total of all reporting groups
118916|NCT01700140|B3|Baseline|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118917|NCT01700140|B2|Baseline|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118918|NCT01700140|B1|Baseline|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118919|NCT01700140|P3|Participant Flow|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118920|NCT01700140|P2|Participant Flow|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118921|NCT01700140|P1|Participant Flow|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118922|NCT01700140|O3|Outcome|SyB D-0701 25 cm2 Patch|SyB D-0701 25 cm2 patch (18.75 mg) was applied to subjects in low dose group and high dose group.
118923|NCT01700140|O2|Outcome|SyB D-0701 15 cm2 Patch|SyB D-0701 15 cm2 patch (11.25 mg) was applied to subjects in high dose group.
118924|NCT01700140|O1|Outcome|Placebo Patch|"Placebo 15 cm2 patch was applied to subjects in placebo group and low dose group.
Placebo 25 cm2 patch was applied to subjects in placebo group."
118925|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118926|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118927|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
119095|NCT01699373|B1|Baseline|Ultrasound-assisted|Pre-procedural ultrasound scan performed
118928|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118929|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118930|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118931|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118932|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118933|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118934|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118935|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
120083|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
118936|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118937|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118938|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118939|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118940|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118941|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118942|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118943|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118944|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118945|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118946|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
119096|NCT01699373|P2|Participant Flow|Manual Palpation|
118947|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118948|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118949|NCT01700140|E3|Reported Event|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118950|NCT01700140|E2|Reported Event|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118951|NCT01700140|E1|Reported Event|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
118952|NCT01699867|B1|Baseline|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
118953|NCT01699867|P1|Participant Flow|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
118954|NCT01699867|O1|Outcome|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
118955|NCT01699867|O1|Outcome|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
118956|NCT01699867|E1|Reported Event|All Patients (Single-arm)|All enrolled study patients.
118957|NCT01699815|B3|Baseline|Total|Total of all reporting groups
118958|NCT01699815|B2|Baseline|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.
Acetaminophen"
119054|NCT01699750|O4|Outcome|BIOTRUE With Acuvue Oasys|BIOTRUE with senofilcon A contact lenses for 30 days
119055|NCT01699750|O3|Outcome|BIOTRUE With Air Optix Aqua|BIOTRUE with lotrafilcon B contact lenses for 30 days
118959|NCT01699815|B1|Baseline|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.
Acetaminophen"
118960|NCT01699815|P2|Participant Flow|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.
Acetaminophen"
118961|NCT01699815|P1|Participant Flow|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.
Acetaminophen"
118962|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.
Acetaminophen"
118963|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.
Acetaminophen"
118964|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.
Acetaminophen"
118965|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.
Acetaminophen"
118966|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.
Acetaminophen"
118967|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.
Acetaminophen"
118968|NCT01699815|E2|Reported Event|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.
Acetaminophen"
118969|NCT01699815|E1|Reported Event|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended for OfirmevTM administration.
Acetaminophen"
118970|NCT01699789|B3|Baseline|Total|Total of all reporting groups
119097|NCT01699373|P1|Participant Flow|Ultrasound-assisted|Pre-procedural ultrasound scan performed
119098|NCT01699373|O2|Outcome|Manual Palpation|
119099|NCT01699373|O1|Outcome|Ultrasound-assisted|Pre-procedural ultrasound scan performed
119100|NCT01699373|E2|Reported Event|Manual Palpation|
119101|NCT01699373|E1|Reported Event|Ultrasound-assisted|Pre-procedural ultrasound scan performed
119102|NCT01699087|B1|Baseline|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
119103|NCT01699087|P1|Participant Flow|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
136537|NCT01627002|P3|Participant Flow|Part A PA401 1.0 mg|
118971|NCT01699789|B2|Baseline|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
118972|NCT01699789|B1|Baseline|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
118973|NCT01699789|P2|Participant Flow|Community Engagement and Planning CEP|"The CEP arm supported 4 months of planning for the CEP Council consisting of representatives from all assigned programs in biweekly 2 hour meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites were provided with enrolled client lists.
QI Program: The QI program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.
CEP Council: The CEP Council was supported by a workbook de"
118974|NCT01699789|P1|Participant Flow|Resources for Services RS|"The RS condition offers time-limited technical assistance to individual agencies, coupled with outreach from a community engagement specialty, to participate in structured reviews of components of the Quality Improvement (QI) Program Intervention as implemented by the RS Expert Team.
QI Program: The quality improvement program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.
RS Expert Team: The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a quality improvement expert, and staff support. T"
119056|NCT01699750|O2|Outcome|OFPM With Acuvue Oasys|OFPM with senofilcon A contact lenses for 30 days
119057|NCT01699750|O1|Outcome|OFPM With Air Optix Aqua|OFPM with lotrafilcon B contact lenses for 30 days
118975|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
118976|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
118977|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119104|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
136538|NCT01627002|P2|Participant Flow|Part A PA401 0.3 mg|
118978|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
118979|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
118980|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
118981|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119058|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
119059|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
119060|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
119061|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
118982|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
118983|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
118984|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
118985|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
118986|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
118987|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
118988|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119062|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
119063|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
119064|NCT01699750|E2|Reported Event|ACUVUE OASYS With HYDRACLEAR|Senofilcon A contact lenses worn for 60 days, replaced biweekly
119065|NCT01699750|E1|Reported Event|AIR OPTIX AQUA|Lotrafilcon B contact lenses worn for 60 days, replaced monthly
118989|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
118990|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119105|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
119106|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
119107|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
119108|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
119109|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
118991|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
118992|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
118993|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
118994|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
118995|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119066|NCT01699685|B3|Baseline|Total|Total of all reporting groups
119067|NCT01699685|B2|Baseline|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
119068|NCT01699685|B1|Baseline|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
119069|NCT01699685|P2|Participant Flow|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
118996|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
118997|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
118998|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
118999|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119000|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119001|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119002|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119070|NCT01699685|P1|Participant Flow|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
119071|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
119072|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
120084|NCT01694108|O2|Outcome|Control Children|No intervention
119003|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119004|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119005|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119006|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119007|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119008|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119009|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119073|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
119074|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
119075|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
120085|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
119010|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119011|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119012|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119013|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119014|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119015|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119016|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119076|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
119077|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
119078|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
120086|NCT01694108|O2|Outcome|Control Children (no Intervention)|
119017|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119018|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119019|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119020|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119021|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119022|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119023|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119079|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
119080|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
119081|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
120087|NCT01694108|O1|Outcome|BCG-vaccine|
119024|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119025|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119026|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119027|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119028|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119029|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119030|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119082|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
119083|NCT01699685|E2|Reported Event|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
119084|NCT01699685|E1|Reported Event|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
119085|NCT01699607|B3|Baseline|Total|Total of all reporting groups
119031|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119032|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119033|NCT01699789|E2|Reported Event|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
119034|NCT01699789|E1|Reported Event|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.
QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
119035|NCT01699763|B1|Baseline|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
119036|NCT01699763|P1|Participant Flow|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
119037|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
119038|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
119039|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
119040|NCT01699763|E1|Reported Event|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
119041|NCT01699750|B3|Baseline|Total|Total of all reporting groups
119042|NCT01699750|B2|Baseline|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
119043|NCT01699750|B1|Baseline|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
119044|NCT01699750|P2|Participant Flow|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
119045|NCT01699750|P1|Participant Flow|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
119046|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
119047|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
119048|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
119086|NCT01699607|B2|Baseline|Nonsmoker Subjects|Nonsmokers are subjects who smoked 40 cigarettes or less in their lifetime, and none within the past year.
119087|NCT01699607|B1|Baseline|Cigarette Smokers|Cigarette smokers are subjects who smoke 10 or more cigarettes per day in the past year.
119088|NCT01699607|P2|Participant Flow|Nonsmoking Subjects|Nonsmokers are subjects who have smoked less than 40 cigarettes in their lifetime, and none within the last year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.
119089|NCT01699607|P1|Participant Flow|Cigarette Smokers|Cigarette smokers are subjects who smoke 10 or more cigarettes per day for the past year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.
119090|NCT01699607|O2|Outcome|Nonsmoking Subjects|Nonsmokers. These are subjects who smoked less than 40 cigarettes in their lifetime and none in the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan
119091|NCT01699607|O1|Outcome|Smoking Subjects|Cigarette smokers. These are subjects who smoke at least 10 cigarettes per day for the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan.
119092|NCT01699607|E1|Reported Event|Amphetamine|"There is only one arm to the study. All subjects will receive amphetamine.
Amphetamine: All subjects will receive amphetamine to induce elevated dopamine levels in the brain."
119093|NCT01699373|B3|Baseline|Total|Total of all reporting groups
119110|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
119111|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
119112|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
119113|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
119114|NCT01699087|E2|Reported Event|PRK ALLEGRETTO|All subjects who underwent PRK surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
119115|NCT01699087|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
119116|NCT01699022|B1|Baseline|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.
Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
119117|NCT01699022|P1|Participant Flow|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.
Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
119118|NCT01699022|O1|Outcome|Cyclofem|
119119|NCT01699022|O1|Outcome|Cyclofem|
119120|NCT01699022|O1|Outcome|Cyclofem|
119121|NCT01699022|O1|Outcome|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.
Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
119122|NCT01699022|O1|Outcome|Cyclofem|
119123|NCT01699022|O1|Outcome|Cyclofem|
119124|NCT01699022|O1|Outcome|Cyclofem|
119125|NCT01699022|O1|Outcome|Cyclofem|
119126|NCT01699022|O1|Outcome|Cyclofem|
119209|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119127|NCT01699022|O1|Outcome|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.
Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
119128|NCT01699022|E1|Reported Event|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.
Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
119129|NCT01698814|B3|Baseline|Total|Total of all reporting groups
119130|NCT01698814|B2|Baseline|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
119131|NCT01698814|B1|Baseline|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
119132|NCT01698814|P2|Participant Flow|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
119133|NCT01698814|P1|Participant Flow|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
119134|NCT01698814|O2|Outcome|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
119135|NCT01698814|O1|Outcome|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
119136|NCT01698814|E2|Reported Event|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
119137|NCT01698814|E1|Reported Event|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
119138|NCT01698801|B1|Baseline|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
119139|NCT01698801|P1|Participant Flow|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
119140|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
119141|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
119142|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
119143|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
119144|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
119145|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.
Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason."
119146|NCT01698801|E1|Reported Event|Lenalidomide Plus Dexamethasone|"Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle
Dexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle"
119147|NCT01698775|B3|Baseline|Total|Total of all reporting groups
119148|NCT01698775|B2|Baseline|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
119149|NCT01698775|B1|Baseline|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
119150|NCT01698775|P2|Participant Flow|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
119151|NCT01698775|P1|Participant Flow|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
119152|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
120088|NCT01694108|E2|Reported Event|Control Children (no Intervention)|
119153|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
119154|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
119155|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
119156|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
119157|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
119158|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
119159|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
119160|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
119161|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
119162|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
119192|NCT01698684|E3|Reported Event|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
119193|NCT01698684|E2|Reported Event|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
119194|NCT01698684|E1|Reported Event|Placebo|Placebo: One dose 15 minutes before attempting intercourse
119163|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
119164|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
119165|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
119166|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
119167|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
119168|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
119169|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
119170|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
119171|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
119172|NCT01698775|E4|Reported Event|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
119210|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119211|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119173|NCT01698775|E3|Reported Event|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
119174|NCT01698775|E2|Reported Event|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
119175|NCT01698775|E1|Reported Event|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
119176|NCT01698710|B1|Baseline|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
119177|NCT01698710|P1|Participant Flow|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
119178|NCT01698710|O1|Outcome|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
119179|NCT01698710|O1|Outcome|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
119180|NCT01698710|O1|Outcome|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
119181|NCT01698710|E1|Reported Event|Albumin Bound Paclitaxel|"Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure."
119182|NCT01698684|B4|Baseline|Total|Total of all reporting groups
119183|NCT01698684|B3|Baseline|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
119184|NCT01698684|B2|Baseline|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
119185|NCT01698684|B1|Baseline|Placebo|Placebo: One dose 15 minutes before attempting intercourse
119186|NCT01698684|P3|Participant Flow|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
119187|NCT01698684|P2|Participant Flow|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
119188|NCT01698684|P1|Participant Flow|Placebo|Placebo: One dose 15 minutes before attempting intercourse
119189|NCT01698684|O3|Outcome|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
119190|NCT01698684|O2|Outcome|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
119191|NCT01698684|O1|Outcome|Placebo|Placebo: One dose 15 minutes before attempting intercourse
119196|NCT01698554|B4|Baseline|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119197|NCT01698554|B3|Baseline|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119198|NCT01698554|B2|Baseline|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119199|NCT01698554|B1|Baseline|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119200|NCT01698554|P4|Participant Flow|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119201|NCT01698554|P3|Participant Flow|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119202|NCT01698554|P2|Participant Flow|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119203|NCT01698554|P1|Participant Flow|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119204|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119205|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119206|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119207|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119208|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
120089|NCT01694108|E1|Reported Event|BCG-vaccine|
119212|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119213|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119214|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119215|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119216|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119217|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119218|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119219|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119220|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119221|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119222|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119223|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119224|NCT01698554|E4|Reported Event|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119225|NCT01698554|E3|Reported Event|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119226|NCT01698554|E2|Reported Event|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119227|NCT01698554|E1|Reported Event|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
119228|NCT01698502|B3|Baseline|Total|Total of all reporting groups
119229|NCT01698502|B2|Baseline|Untrained|Healthy, sedentary (Maximal oxygen uptake (VO2max), ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
119230|NCT01698502|B1|Baseline|Trained|Healthy, Endurance trained (Maximal oxygen uptake (VO2max), ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
119231|NCT01698502|P2|Participant Flow|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
119232|NCT01698502|P1|Participant Flow|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
119233|NCT01698502|O2|Outcome|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
119234|NCT01698502|O1|Outcome|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
119235|NCT01698502|O2|Outcome|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
119236|NCT01698502|O1|Outcome|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
119237|NCT01698502|E2|Reported Event|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
119238|NCT01698502|E1|Reported Event|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
119239|NCT01698320|B3|Baseline|Total|Total of all reporting groups
119240|NCT01698320|B2|Baseline|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119241|NCT01698320|B1|Baseline|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119242|NCT01698320|P3|Participant Flow|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119257|NCT01698320|E4|Reported Event|Albuterol MDPI (Formerly Albuterol) - Open Label Period|After completing 12 weeks of albuterol QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
119243|NCT01698320|P2|Participant Flow|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119244|NCT01698320|P1|Participant Flow|All Enrolled Subjects|Includes subjects who were enrolled in study and participated in the single-blind (subjects were blinded) run-in period in which subjects used the inhaler with placebo and maintained the diary for about one week prior to randomization and starting the 12-week double-blind period.
119245|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119246|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119247|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119248|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119249|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119250|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119497|NCT01697345|O1|Outcome|FSFI Pain Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
119251|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119252|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119253|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119254|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119255|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119256|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
119258|NCT01698320|E3|Reported Event|Albuterol MDPI (Formerly Placebo) - Open Label Period|After completing 12 weeks of placebo QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
119259|NCT01698320|E2|Reported Event|Placebo MDPI - Double-blind Period|Placebo delivered using a multi-dose dry powder inhaler (MDPI or Spiromax) as 2 inhalations four times a day for the 12 week double-blind period.
119260|NCT01698320|E1|Reported Event|Albuterol MDPI - Double-blind Period|Albuterol multi-dose dry powder inhaler (MDPI or Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period.
119261|NCT01698268|B3|Baseline|Total|Total of all reporting groups
119262|NCT01698268|B2|Baseline|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.
Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
119263|NCT01698268|B1|Baseline|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.
TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
119264|NCT01698268|P2|Participant Flow|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.
Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
119265|NCT01698268|P1|Participant Flow|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.
TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
119266|NCT01698268|O2|Outcome|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.
Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
119267|NCT01698268|O1|Outcome|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.
TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
119268|NCT01698268|E2|Reported Event|Local Infiltration Group|"Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.
Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon."
119269|NCT01698268|E1|Reported Event|TAP Group|"Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.
TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist."
119270|NCT01697969|B1|Baseline|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
119271|NCT01697969|P1|Participant Flow|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
119272|NCT01697969|O2|Outcome|Right Eye|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
119273|NCT01697969|O1|Outcome|Left Eye|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
119274|NCT01697969|E1|Reported Event|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
119275|NCT01697956|B3|Baseline|Total|Total of all reporting groups
119276|NCT01697956|B2|Baseline|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
119277|NCT01697956|B1|Baseline|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
119278|NCT01697956|P2|Participant Flow|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
119279|NCT01697956|P1|Participant Flow|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
119280|NCT01697956|O4|Outcome|Placebo Nasal Aerosol - Shift to Low|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
119281|NCT01697956|O3|Outcome|Placebo Nasal Aerosol - Shift to High|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
119282|NCT01697956|O2|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to Low|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
119283|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to High|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
119284|NCT01697956|O4|Outcome|Placebo Nasal Aerosol - Shift to Low|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
119285|NCT01697956|O3|Outcome|Placebo Nasal Aerosol - Shift to High|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
119286|NCT01697956|O2|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to Low|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
119287|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to High|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
119288|NCT01697956|O2|Outcome|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
119289|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
119290|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
119291|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
119292|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
119293|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
119294|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
119295|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
119296|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
119297|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
119298|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
119299|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
119300|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
119301|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
119302|NCT01697956|O2|Outcome|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
119303|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
119304|NCT01697956|E2|Reported Event|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
119305|NCT01697956|E1|Reported Event|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
119306|NCT01697696|B3|Baseline|Total|Total of all reporting groups
119307|NCT01697696|B2|Baseline|QAB149|75 μg once-daily
119308|NCT01697696|B1|Baseline|NVA237|12.5 μg twice-daily
119309|NCT01697696|P2|Participant Flow|QAB149|75 μg once-daily
119310|NCT01697696|P1|Participant Flow|NVA237|12.5 μg twice-daily
119311|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
119312|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
119313|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
119314|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
119315|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
119316|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
119317|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
119318|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
119319|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
119320|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
119321|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
119322|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
119323|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
119324|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
119325|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
119326|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
119327|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
119328|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
119332|NCT01697592|B10|Baseline|Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119333|NCT01697592|B9|Baseline|Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZD (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
119334|NCT01697592|B8|Baseline|Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG throughout the duration of the study.
119335|NCT01697592|B7|Baseline|Placebo/Gln (Phase A) Switching to Omari. 25 mg/Gln (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
119336|NCT01697592|B6|Baseline|Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)|Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
119337|NCT01697592|B5|Baseline|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119338|NCT01697592|B4|Baseline|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
119339|NCT01697592|B3|Baseline|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
119340|NCT01697592|B2|Baseline|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
119441|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
119341|NCT01697592|B1|Baseline|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
119342|NCT01697592|P10|Participant Flow|Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119343|NCT01697592|P9|Participant Flow|Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZ (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
119344|NCT01697592|P8|Participant Flow|Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG. throughout the duration of the study.
119345|NCT01697592|P7|Participant Flow|Placebo/Gln. (Phase A) Switching to Omari. 25 mg/Gln (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
119346|NCT01697592|P6|Participant Flow|Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)|Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
119347|NCT01697592|P5|Participant Flow|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GI) throughout the duration of the study.
119348|NCT01697592|P4|Participant Flow|Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
119349|NCT01697592|P3|Participant Flow|Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
119350|NCT01697592|P2|Participant Flow|Omarigliptin 25 mg/Glinides (Gln) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
119351|NCT01697592|P1|Participant Flow|Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
119352|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119353|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
119354|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
136539|NCT01627002|P1|Participant Flow|Part A PA401 0.1 mg|
119355|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln. throughout the duration of the study.
119356|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
119357|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119358|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
119359|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
119360|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
119361|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
119362|NCT01697592|O10|Outcome|Omarigliptin 25mg/α-GI (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119363|NCT01697592|O9|Outcome|Omarigliptin 25mg/TZD (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.
119364|NCT01697592|O8|Outcome|Omarigliptin 25mg/BG (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG. throughout the duration of the study.
119365|NCT01697592|O7|Outcome|Omarigliptin 25mg/Gln (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.
Participants continued pre-study basal medication of Gln throughout the duration of the study."
119366|NCT01697592|O6|Outcome|Omarigliptin 25mg/SU (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.
Participants continued prestudy basal medication of SU throughout the duration of the study."
119367|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119368|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
119369|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
119370|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
119371|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
119372|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119373|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
119374|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
119375|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
119376|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
119377|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119378|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
119379|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
119380|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
119381|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
119382|NCT01697592|O10|Outcome|Omarigliptin 25mg/α-GI (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119383|NCT01697592|O9|Outcome|Omarigliptin 25mg/TZD (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.
119384|NCT01697592|O8|Outcome|Omarigliptin 25mg/BG (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG throughout the duration of the study.
119385|NCT01697592|O7|Outcome|Omarigliptin 25mg/Gln (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.
Participants continued pre-study basal medication of Gln throughout the duration of the study."
119386|NCT01697592|O6|Outcome|Omarigliptin 25mg/SU (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.
Participants continued prestudy basal medication of SU throughout the duration of the study."
119387|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119388|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
119389|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
119390|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
119391|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
119392|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119393|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
119394|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
119442|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
119395|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
119396|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
119397|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119398|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
119399|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
119400|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
119401|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
119402|NCT01697592|E12|Reported Event|Omarigliptin 25mg/ABM (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.
Participants continued any prestudy basal medications throughout the duration of the study."
119403|NCT01697592|E11|Reported Event|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119404|NCT01697592|E10|Reported Event|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
119405|NCT01697592|E9|Reported Event|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
119406|NCT01697592|E8|Reported Event|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
119407|NCT01697592|E7|Reported Event|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
119408|NCT01697592|E6|Reported Event|Placebo/ABM (Phase A)|Placebo to omargliptin administered orally once weekly for 24 weeks during Phase A. Participants continued any pre-study basal medication (ABM)throughout the duration of the study.
119409|NCT01697592|E5|Reported Event|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
119410|NCT01697592|E4|Reported Event|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
119603|NCT01696773|E2|Reported Event|Red Tomato Juice|"Red tomato juice will be fed
Red tomato juice: Post-prandial feeding study"
119411|NCT01697592|E3|Reported Event|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
119412|NCT01697592|E2|Reported Event|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
119413|NCT01697592|E1|Reported Event|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
119414|NCT01697501|B1|Baseline|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
119415|NCT01697501|P1|Participant Flow|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
119416|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
119417|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
119418|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
119419|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
119420|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
119421|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
119422|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
119423|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
119424|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
119425|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
119426|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
119427|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
119428|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
119429|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
119430|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
119431|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
119432|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
119433|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
119434|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
119435|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
119436|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
119437|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
119438|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
119439|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
119440|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
119456|NCT01697501|E1|Reported Event|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
119457|NCT01697462|B1|Baseline|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
119458|NCT01697462|P1|Participant Flow|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of metastatic colorectal cancer (mCRC) were followed until progression of the disease (PD), unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
119459|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
119460|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
119461|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
119462|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
119463|NCT01697462|E1|Reported Event|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
119464|NCT01697449|B1|Baseline|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
119465|NCT01697449|P1|Participant Flow|Colorectal Cancer (CRC) Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
119466|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
119467|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
119468|NCT01697449|O1|Outcome|Unresectable|Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
119469|NCT01697449|O2|Outcome|Unresectable CRC at Baseline|Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
119470|NCT01697449|O1|Outcome|Resectable/Potentially Resectable CRC at Baseline|Participants with resectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
119471|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
119472|NCT01697449|E1|Reported Event|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
119473|NCT01697358|B3|Baseline|Total|Total of all reporting groups
119474|NCT01697358|B2|Baseline|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
119475|NCT01697358|B1|Baseline|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
119487|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
119538|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119539|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
119476|NCT01697358|P2|Participant Flow|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
119477|NCT01697358|P1|Participant Flow|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
119478|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
119479|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
119480|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
119481|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
119496|NCT01697345|O2|Outcome|FSFI Pain Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
136540|NCT01627002|O3|Outcome|Part B Placebo|
119482|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
119483|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
119484|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
119485|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
119486|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
119536|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119537|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
119488|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
119489|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
119490|NCT01697358|E2|Reported Event|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
119491|NCT01697358|E1|Reported Event|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
119492|NCT01697345|B1|Baseline|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
119493|NCT01697345|P1|Participant Flow|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
119494|NCT01697345|O2|Outcome|Did Not Continue Vaginal Testosterone Therapy|Participants who chose not to continue vaginal testosterone upon completion of the study.
119495|NCT01697345|O1|Outcome|Continued Vaginal Testosterone Therapy|Participants who chose to continue vaginal testosterone therapy upon completion of the study.
119498|NCT01697345|O2|Outcome|FSFI Satisfaction Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
119499|NCT01697345|O1|Outcome|FSFI Satisfaction Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
119500|NCT01697345|O2|Outcome|FSFI Orgasm Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
119501|NCT01697345|O1|Outcome|FSFI Orgasm Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
119502|NCT01697345|O2|Outcome|FSFI Lubrication Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
119503|NCT01697345|O1|Outcome|FSFI Lubrication Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
119504|NCT01697345|O2|Outcome|FSFI Arousal Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
119505|NCT01697345|O1|Outcome|FSFI Arousal Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
119506|NCT01697345|O2|Outcome|FSFI Desire Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
119507|NCT01697345|O1|Outcome|FSFI Desire Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
119508|NCT01697345|O2|Outcome|FSFI Total Score (Postteset)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
119509|NCT01697345|O1|Outcome|FSFI Total Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
119510|NCT01697345|E1|Reported Event|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
119511|NCT01697319|B1|Baseline|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
119512|NCT01697319|P1|Participant Flow|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
119513|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
119514|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
119515|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
119516|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
119517|NCT01697319|E1|Reported Event|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
119518|NCT01696994|B3|Baseline|Total|Total of all reporting groups
119519|NCT01696994|B2|Baseline|Ovarian Screening|Participants undergo blood sample collection for Cancer Antigen 125 (CA-125) analysis at baseline and annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119520|NCT01696994|B1|Baseline|Control|Participants receive standard medical care. Participants complete a baseline questionnaire (BQ) at entry and a dietary history questionnaire (DHQ) during study years 0-6.
119521|NCT01696994|P2|Participant Flow|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119522|NCT01696994|P1|Participant Flow|Control|Participants receive standard medical care.
119523|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
121067|NCT01689207|P5|Participant Flow|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
119524|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119525|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119526|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
119527|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119528|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119529|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119530|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119531|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119532|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119533|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119534|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119535|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119717|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119540|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119541|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
119542|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119543|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
119544|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119545|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
119546|NCT01696994|E1|Reported Event|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
119547|NCT01696981|B3|Baseline|Total|Total of all reporting groups
119548|NCT01696981|B2|Baseline|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
119549|NCT01696981|B1|Baseline|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
119550|NCT01696981|P2|Participant Flow|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
119551|NCT01696981|P1|Participant Flow|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
119552|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
119553|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
136541|NCT01627002|O2|Outcome|Part B 1.0 mg PA401|
119554|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
119555|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
119556|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
119557|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
119558|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
119559|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
119560|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
119613|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.
acetylsalicylic acid: 325 mg twice a day
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119561|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
119562|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
119563|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
119564|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
119565|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
119566|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
119567|NCT01696981|E1|Reported Event|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
119568|NCT01696968|B3|Baseline|Total|Total of all reporting groups
119569|NCT01696968|B2|Baseline|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119570|NCT01696968|B1|Baseline|Control|Participants receive standard medical care.
119571|NCT01696968|P2|Participant Flow|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119572|NCT01696968|P1|Participant Flow|Control|Participants receive standard medical care.
119573|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119574|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119575|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119576|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
119577|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119578|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119579|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119580|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119581|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
119582|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119583|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
119584|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119585|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
119586|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119587|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
119588|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119589|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
119590|NCT01696968|E1|Reported Event|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
119713|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
120090|NCT01693900|B3|Baseline|Total|Total of all reporting groups
119591|NCT01696929|B1|Baseline|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.
Tocilizumab: Therapeutic/Pharmacologic Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion."
119592|NCT01696929|P1|Participant Flow|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of Tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of Tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.
Tocilizumab: Therapeutic/Pharmacological Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion."
119593|NCT01696929|O1|Outcome|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.
Tocilizumab: Therapeutic/Pharmacologic Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion."
119594|NCT01696929|O1|Outcome|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.
Tocilizumab: Therapeutic/Pharmacologic Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion."
119595|NCT01696929|E1|Reported Event|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.
Tocilizumab: Therapeutic/Pharmacologic Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion."
119596|NCT01696773|B3|Baseline|Total|Total of all reporting groups
119597|NCT01696773|B2|Baseline|Red Tomato Juice First, Then Tangerine Tomato Juice|Red tomato juice is consumed on day 14, then tangerine tomato juice on day 28
119598|NCT01696773|B1|Baseline|Tangerine Tomato Juice First, Then Red Tomato Juice|Tangerine tomato juice is consumed on day 14 then red tomato juice on day 28
119599|NCT01696773|P2|Participant Flow|Red Tomato Juice First, Then Tangerine Tomato Juice|Red tomato juice will be fed, followed by a 14 day washout, then tangerine tomato juice will be fed.
119600|NCT01696773|P1|Participant Flow|Tangerine Tomato Juice First, Then Red Tomato Juice|Tangerine tomato juice will be fed, followed by a 14 day washout, and then red tomato juice will be fed
119601|NCT01696773|O2|Outcome|Red Tomato Juice|"Red tomato juice will be fed
Red tomato juice: Post-prandial feeding study"
119602|NCT01696773|O1|Outcome|Tangerine Tomato Juice|"Tangerine tomato juice will be fed
Tangerine tomato juice: Post-prandial feeding study"
119604|NCT01696773|E1|Reported Event|Tangerine Tomato Juice|"Tangerine tomato juice will be fed
Tangerine tomato juice: Post-prandial feeding study"
119605|NCT01696760|B3|Baseline|Total|Total of all reporting groups
119606|NCT01696760|B2|Baseline|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.
enoxaparin: 40 mg once daily
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119607|NCT01696760|B1|Baseline|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.
acetylsalicylic acid: 325 mg twice a day
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119608|NCT01696760|P2|Participant Flow|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.
enoxaparin: 40 mg once daily
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119609|NCT01696760|P1|Participant Flow|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.
acetylsalicylic acid: 325 mg twice a day
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119610|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.
enoxaparin: 40 mg once daily
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119611|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.
acetylsalicylic acid: 325 mg twice a day
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119612|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.
enoxaparin: 40 mg once daily
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119714|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119614|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.
enoxaparin: 40 mg once daily
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119615|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.
acetylsalicylic acid: 325 mg twice a day
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119616|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.
enoxaparin: 40 mg once daily
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119617|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.
acetylsalicylic acid: 325 mg twice a day
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119618|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.
enoxaparin: 40 mg once daily
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119619|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.
acetylsalicylic acid: 325 mg twice a day
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119620|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.
enoxaparin: 40 mg once daily
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119621|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.
acetylsalicylic acid: 325 mg twice a day
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119622|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.
enoxaparin: 40 mg once daily
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119623|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.
acetylsalicylic acid: 325 mg twice a day
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119624|NCT01696760|E2|Reported Event|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.
enoxaparin: 40 mg once daily
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
121068|NCT01689207|P4|Participant Flow|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
119625|NCT01696760|E1|Reported Event|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.
acetylsalicylic acid: 325 mg twice a day
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
119626|NCT01696695|B1|Baseline|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
119627|NCT01696695|P1|Participant Flow|Metastatic Colorectal Carcinoma (mCRC) Participants|Newly diagnosed metastatic colorectal carcinoma (mCRC) participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
119628|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
119629|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
119630|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
119631|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
119715|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119632|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
119633|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
119634|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
119635|NCT01696695|E1|Reported Event|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
119636|NCT01696643|B3|Baseline|Total|Total of all reporting groups
119637|NCT01696643|B2|Baseline|Placebo|Placebo, administered orally, BID for 52 weeks
119638|NCT01696643|B1|Baseline|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
119639|NCT01696643|P2|Participant Flow|Placebo|Placebo, administered orally, BID for 52 weeks
119640|NCT01696643|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945, administered orally, twice daily (BID) for 52 weeks
119641|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
119642|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
119643|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
119644|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
119645|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
119646|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
119647|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
119648|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
119649|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
119650|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
119651|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
119652|NCT01696643|E2|Reported Event|Placebo|Placebo, administered orally, BID for 52 weeks
119653|NCT01696643|E1|Reported Event|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
119654|NCT01696357|B3|Baseline|Total|Total of all reporting groups
119669|NCT01696214|P3|Participant Flow|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.
Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
119655|NCT01696357|B2|Baseline|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
119656|NCT01696357|B1|Baseline|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
119657|NCT01696357|P2|Participant Flow|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
119658|NCT01696357|P1|Participant Flow|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
119659|NCT01696357|O2|Outcome|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
119716|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119660|NCT01696357|O1|Outcome|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
119661|NCT01696357|E2|Reported Event|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
119662|NCT01696357|E1|Reported Event|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
119663|NCT01696214|B5|Baseline|Total|Total of all reporting groups
119664|NCT01696214|B4|Baseline|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.
Fluticasone 250 mg/salmeterol 50 mg:
Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
119665|NCT01696214|B3|Baseline|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.
Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
119666|NCT01696214|B2|Baseline|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.
Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks"
119667|NCT01696214|B1|Baseline|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.
Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
119668|NCT01696214|P4|Participant Flow|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.
Fluticasone 250 mg/salmeterol 50 mg:
Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
119670|NCT01696214|P2|Participant Flow|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.
Theophylline: Participants will be assigned to theophylline 400 mg once a day for 24 weeks"
119671|NCT01696214|P1|Participant Flow|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and placebo montelukast.
Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
119672|NCT01696214|O4|Outcome|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, ipratropium, and montelukast.
Fluticasone 250 mg/salmeterol 50 mg: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo"
119673|NCT01696214|O3|Outcome|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and ipratropium.
Montelukast 10mg: Participants will be assigned to Leukotriene receptor antagonist once a day for 24 weeks."
119674|NCT01696214|O2|Outcome|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and montelukast.
Theophylline 400 mg: Participants will be assigned to Theophylline once a day for 24 weeks"
119675|NCT01696214|O1|Outcome|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and montelukast.
ipratropium: Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks."
119676|NCT01696214|E4|Reported Event|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.
Fluticasone 250 mg/salmeterol 50 mg:
Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
119677|NCT01696214|E3|Reported Event|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.
Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
119678|NCT01696214|E2|Reported Event|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.
Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks"
119679|NCT01696214|E1|Reported Event|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.
Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
119680|NCT01696188|B3|Baseline|Total|Total of all reporting groups
119681|NCT01696188|B2|Baseline|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plan approach.
interscalene nerve catheter"
119682|NCT01696188|B1|Baseline|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.
interscalene nerve catheter"
119683|NCT01696188|P2|Participant Flow|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.
interscalene nerve catheter"
119684|NCT01696188|P1|Participant Flow|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.
interscalene nerve catheter"
119685|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.
interscalene nerve catheter"
119686|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.
interscalene nerve catheter"
119687|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.
interscalene nerve catheter"
119688|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.
interscalene nerve catheter"
119689|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.
interscalene nerve catheter"
119690|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.
interscalene nerve catheter"
119691|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.
interscalene nerve catheter"
119692|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.
interscalene nerve catheter"
119693|NCT01696188|E2|Reported Event|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.
interscalene nerve catheter"
119694|NCT01696188|E1|Reported Event|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.
interscalene nerve catheter"
119695|NCT01696071|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
119696|NCT01696071|P2|Participant Flow|Tio R5 QD / Tio R2.5 BID|"Subjects were randomised to receive treatment with 2.5 μg tiotropium inhalation solution twice daily (i.e. in the morning and in the evening) and 5 μg tiotropium inhalation solution once daily in the evening via Respimat inhaler in a crossover manner using a predefined randomisation sequence.
Treatment 1: Tio 5 µg QD (once daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 5 µg once daily i.e 2 actuations of 2.5 µg tiotropium in the evening and 2 actuations of placebo in the morning (total daily dose of 5 μg) Treatment 2: Tio 2.5 µg BID (twice daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 2.5 µg twice daily i.e 2 actuations of 1.25 µg tiotropium in the morning and in the evening (total daily dose of 5 μg)"
119732|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119759|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119697|NCT01696071|P1|Participant Flow|Tio R2.5 Twice Daily (BID) / Tio R5 Once Daily (QD)|"Subjects were randomised to receive treatment with 2.5 μg tiotropium inhalation solution twice daily (i.e. in the morning and in the evening) and 5 μg tiotropium inhalation solution once daily in the evening via Respimat inhaler in a crossover manner using a predefined randomisation sequence.
Treatment 1: Tio 2.5 µg BID (twice daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 2.5 µg twice daily i.e 2 actuations of 1.25 µg tiotropium in the morning and in the evening (total daily dose of 5 μg) Treatment 2: Tio 5 µg QD (once daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 5 µg once daily i.e 2 actuations of 2.5 µg tiotropium in the evening and 2 actuations of placebo in the morning (total daily dose of 5 μg)"
119698|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119699|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119700|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119701|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119702|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119703|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119704|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119705|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119706|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119707|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119708|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119709|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119710|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119711|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119712|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119718|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119719|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with inhaled corticosteroid (iCS).
119720|NCT01696071|E2|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119721|NCT01696071|E1|Reported Event|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
119722|NCT01696058|B3|Baseline|Total|Total of all reporting groups
119723|NCT01696058|B2|Baseline|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119724|NCT01696058|B1|Baseline|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose
Tiotropium: Marketed dose"
119725|NCT01696058|P2|Participant Flow|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119726|NCT01696058|P1|Participant Flow|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose
Tiotropium: Marketed dose"
119727|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119728|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119729|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119730|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119731|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
121069|NCT01689207|P3|Participant Flow|Part B: Placebo|Placebo
119733|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119734|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119735|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119736|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119737|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119738|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119739|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119740|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119741|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119742|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119743|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119744|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119745|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119746|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119747|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119748|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119749|NCT01696058|E2|Reported Event|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119750|NCT01696058|E1|Reported Event|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119751|NCT01696045|B3|Baseline|Total|Total of all reporting groups
119752|NCT01696045|B2|Baseline|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119753|NCT01696045|B1|Baseline|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119754|NCT01696045|P2|Participant Flow|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119755|NCT01696045|P1|Participant Flow|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119756|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119757|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119758|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
136542|NCT01627002|O1|Outcome|Part B 3.0 mg PA401|
119760|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119761|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119762|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119763|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119764|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119765|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119766|NCT01696045|O2|Outcome|Ipilimumab 10mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119767|NCT01696045|O1|Outcome|Ipilimumab 3mg/kg|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119768|NCT01696045|E2|Reported Event|IPILIMUMAB 10 MG/KG|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119769|NCT01696045|E1|Reported Event|IPILIMUMAB 3 MG/KG|Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
119770|NCT01695772|B1|Baseline|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
119771|NCT01695772|P1|Participant Flow|Bevacizumab|Participants received standard 5-Flurouracil (5-FU) based chemotherapy plus bevacizumab 5 milligrams per kilograms (mg/kg) intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
119772|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
119773|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
119774|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
120201|NCT01692938|O1|Outcome|No Retinal Disease|
119775|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
119776|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
119777|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
119778|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
119779|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
119780|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
119781|NCT01695772|E1|Reported Event|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
119782|NCT01695746|B1|Baseline|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119783|NCT01695746|P1|Participant Flow|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119784|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119785|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119786|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119787|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119788|NCT01695746|O1|Outcome|C.E.R.A (Continuous Erythropoietin Receptor Activator)|Participants with chronic renal anemia Stage III-IV, not on dialysis, receiving therapy with C.E.R.A. according to routine clinical practice were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 μg/kg of C.E.R.A once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 μg either once monthly; or 60, 100, or 180 μg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119817|NCT01695304|B2|Baseline|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
120202|NCT01692938|O2|Outcome|Retinal Disease|
120203|NCT01692938|O1|Outcome|No Retinal Disease|
119789|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119790|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119791|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119792|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119793|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119826|NCT01695304|E1|Reported Event|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.
Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
119794|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119795|NCT01695746|E1|Reported Event|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
119796|NCT01695668|B3|Baseline|Total|Total of all reporting groups
119797|NCT01695668|B2|Baseline|Restasis|Cyclosporine
119798|NCT01695668|B1|Baseline|Lotemax|Loteprednol Etabonate 0.5%
119799|NCT01695668|P2|Participant Flow|Restasis|Cyclosporine
119800|NCT01695668|P1|Participant Flow|Lotemax|Loteprednol Etabonate 0.5%
119801|NCT01695668|O2|Outcome|Restasis|Cyclosporine
119802|NCT01695668|O1|Outcome|Lotemax|Loteprednol Etabonate 0.5%
119803|NCT01695668|E2|Reported Event|Restasis|"Cyclosporine
Restasis"
119804|NCT01695668|E1|Reported Event|Lotemax|"Loteprednol Etabonate 0.5%
Lotemax"
119805|NCT01695369|B1|Baseline|Overall Study Participants|Senofilcon A and Comfilcon A
119806|NCT01695369|P1|Participant Flow|Overall Study Participants|Senofilcon A and Comfilcon A
119807|NCT01695369|O2|Outcome|Senofilcon A|Senofilcon A (Vistakon Acuvue® Oasys)
119808|NCT01695369|O1|Outcome|Comfilcon A|comfilcon A (CooperVision Biofinity®Sphere)
119809|NCT01695369|E2|Reported Event|Comfilcon A|Comfilcon A / CooperVision Biofinity Sphere
119810|NCT01695369|E1|Reported Event|Overall Study Participants|Senofilcon A and Comfilcon A
119811|NCT01695330|B1|Baseline|Subcutaneous Bortezomib|
119812|NCT01695330|P2|Participant Flow||This is one-arm study.
119813|NCT01695330|P1|Participant Flow|Subcutaneous Bortezomib|patients with MM who received treatment with a SC bortezomib-containing combination. The patients were required to have received a prior IV bortezomib containing combination regimen that differs from the SC bortezomib-containing treatment.
119814|NCT01695330|O1|Outcome|Subcutaneous Bortezomib|Patients with MM who received treatment with a SC bortezomib-containing combination
119815|NCT01695330|E1|Reported Event|Subcutaneous Bortezomib|Bortezomib was administered SC at a dose of 1.0 mg/m2. Doses were administered on days 1, 4, 8, and 11 of a 28-day cycle. When administered subcutaneously, sites for each injection (thigh or abdomen) were rotated and reported. All other drugs used in combination with the SC bortezomib were recorded in the Case Report Forms along with their corresponding doses and schedules.
119816|NCT01695304|B3|Baseline|Total|Total of all reporting groups
119818|NCT01695304|B1|Baseline|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.
Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
119819|NCT01695304|P2|Participant Flow|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
119820|NCT01695304|P1|Participant Flow|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.
Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
119821|NCT01695304|O2|Outcome|Control Group|Control Group who did not receive ceramic water filters (until after the trial ended)
119822|NCT01695304|O1|Outcome|Intervention Group|Intervention group who received ceramic water filters
119823|NCT01695304|O2|Outcome|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
119824|NCT01695304|O1|Outcome|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.
Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
119825|NCT01695304|E2|Reported Event|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
119827|NCT01695239|B5|Baseline|Total|Total of all reporting groups
120028|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
119828|NCT01695239|B4|Baseline|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119829|NCT01695239|B3|Baseline|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119830|NCT01695239|B2|Baseline|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119831|NCT01695239|B1|Baseline|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119832|NCT01695239|P4|Participant Flow|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119833|NCT01695239|P3|Participant Flow|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab (ixe) Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119834|NCT01695239|P2|Participant Flow|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119835|NCT01695239|P1|Participant Flow|Placebo|Participants received placebo for ixekizumab as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.
119836|NCT01695239|O3|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
120013|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
119837|NCT01695239|O2|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119838|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119839|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119840|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119841|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119842|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119843|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119844|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119845|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119846|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
120323|NCT01691781|O1|Outcome|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
119847|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119848|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119849|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119850|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119851|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119852|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119853|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119854|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119855|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119856|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119857|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119858|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119859|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119860|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119861|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119862|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119863|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119864|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119865|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119866|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
136543|NCT01627002|O3|Outcome|Part B Placebo|
119867|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119868|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119869|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119870|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119871|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119872|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119873|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119874|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119875|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119876|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
120064|NCT01694108|O2|Outcome|Control Children|No intervention
119877|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119878|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119879|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119880|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119881|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119882|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119883|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119884|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119885|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119886|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119887|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119888|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119889|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119890|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119891|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119892|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119893|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119894|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119895|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119896|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
120065|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
119897|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119898|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119899|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119900|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119901|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119902|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119903|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119904|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119905|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119906|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119907|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119908|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119909|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119910|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119911|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119912|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119913|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119914|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119915|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119916|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
120066|NCT01694108|O2|Outcome|Control Children|No intervention
119917|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119918|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119919|NCT01695239|E4|Reported Event|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119920|NCT01695239|E3|Reported Event|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
119921|NCT01695239|E2|Reported Event|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
119922|NCT01695239|E1|Reported Event|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
119923|NCT01695044|B3|Baseline|Total|Total of all reporting groups
119924|NCT01695044|B2|Baseline|Arm 2: PSMA ADC Chemotherapy-naive|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.
119925|NCT01695044|B1|Baseline|Arm 1: PSMA ADC Chemotherapy-experienced|PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
119926|NCT01695044|P1|Participant Flow|Arm 1: PSMA ADC|PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
119927|NCT01695044|O2|Outcome|Chemotherapy-naive|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it."
119928|NCT01695044|O1|Outcome|PSMA ADC Chemotherapy-experienced|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation)."
136544|NCT01627002|O2|Outcome|Part B 1.0 mg PA401|
119929|NCT01695044|O2|Outcome|Chemotherapy-naive|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it."
119930|NCT01695044|O1|Outcome|PSMA ADC Chemotherapy-experienced|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation)."
119931|NCT01695044|O2|Outcome|Chemotherapy-naive|"Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it."
119932|NCT01695044|O1|Outcome|PSMA ADC Chemotherapy-experienced|"Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation)."
119933|NCT01695044|E2|Reported Event|Chemotherapy-naive|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
119934|NCT01695044|E1|Reported Event|PSMA ADC Chemotherapy-experienced|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
119935|NCT01694771|B3|Baseline|Total|Total of all reporting groups
119936|NCT01694771|B2|Baseline|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119937|NCT01694771|B1|Baseline|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose
Tiotropium: Marketed dose"
119938|NCT01694771|P2|Participant Flow|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119939|NCT01694771|P1|Participant Flow|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose
Tiotropium: Marketed dose"
120067|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
119940|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119941|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119942|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119943|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119944|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119945|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119946|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119947|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119948|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119949|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
120324|NCT01691781|O2|Outcome|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
119950|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119951|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119952|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119953|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119954|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119955|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119956|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119957|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119958|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119959|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119960|NCT01694771|E2|Reported Event|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning
Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
119961|NCT01694771|E1|Reported Event|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol: One dose, 2 inhalations once daily in the morning
Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
119962|NCT01694706|B1|Baseline|Entire Study Population|"All subjects received all tested treatments in a randomised, open label, 3-way cross over study. The treatments were:
Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.
Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.
Drug administrations were separated by a washout period of at least 14 days"
119963|NCT01694706|P3|Participant Flow|Faldaprevir+ OMP/ Faldaprevir Fed/ Faldaprevir|"Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.
Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.
Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration"
119964|NCT01694706|P2|Participant Flow|Faldaprevir Fed/ Faldaprevir/ Faldaprevir+ OMP|"Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.
Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir."
119965|NCT01694706|P1|Participant Flow|Faldaprevir/Faldaprevir+ OMP/Faldaprevir Fed|"Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration.
Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.
Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less."
119966|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
119967|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
119968|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
119969|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
119970|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
119971|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
119972|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
119973|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
119974|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
119975|NCT01694706|E4|Reported Event|Omeprazole|40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
119976|NCT01694706|E3|Reported Event|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast
119977|NCT01694706|E2|Reported Event|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
119978|NCT01694706|E1|Reported Event|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
119979|NCT01694667|B3|Baseline|Total|Total of all reporting groups
119980|NCT01694667|B2|Baseline|Placebo|Participants randomized to placebo
119981|NCT01694667|B1|Baseline|Omega-3|Participants randomized to omega-3
119982|NCT01694667|P2|Participant Flow|Placebo|"Placebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil.
Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).
28 participants allocated to this group."
119983|NCT01694667|P1|Participant Flow|Omega-3 Fatty Acids|"Omega-3 fatty acids will be delivered in orange-flavored pudding packets and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).
Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).
29 participants allocated to this group."
119984|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
119985|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
119986|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
119987|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
119988|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
119989|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
119990|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
119991|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
119992|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
119993|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
119994|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
119995|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
119996|NCT01694667|E2|Reported Event|Placebo|Participants randomized to placebo
119997|NCT01694667|E1|Reported Event|Omega-3|Participants randomized to omega-3
119998|NCT01694641|B3|Baseline|Total|Total of all reporting groups
119999|NCT01694641|B2|Baseline|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
120026|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
120027|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
120000|NCT01694641|B1|Baseline|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.
time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
120001|NCT01694641|P2|Participant Flow|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
120002|NCT01694641|P1|Participant Flow|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.
time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
120003|NCT01694641|O2|Outcome|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
120004|NCT01694641|O1|Outcome|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.
time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
120005|NCT01694641|E2|Reported Event|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
120006|NCT01694641|E1|Reported Event|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.
time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
120007|NCT01694420|B1|Baseline|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
120008|NCT01694420|P1|Participant Flow|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
120009|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
120010|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
120011|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
120012|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
120068|NCT01694108|O2|Outcome|Control Children|No intervention
120014|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
120015|NCT01694420|E1|Reported Event|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
120016|NCT01694199|B3|Baseline|Total|Total of all reporting groups
120017|NCT01694199|B2|Baseline|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
120018|NCT01694199|B1|Baseline|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
120019|NCT01694199|P2|Participant Flow|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
120020|NCT01694199|P1|Participant Flow|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
120021|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
120022|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
120023|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
120024|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
120025|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
120682|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
120683|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
120029|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
120030|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
120031|NCT01694199|E2|Reported Event|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
120032|NCT01694199|E1|Reported Event|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
120033|NCT01694108|B3|Baseline|Total|Total of all reporting groups
120034|NCT01694108|B2|Baseline|Control Children|No intervention
120035|NCT01694108|B1|Baseline|BCG-vaccine|SSI strain 1331 standard dose
120036|NCT01694108|P2|Participant Flow|Control Children (no Intervention)|
120037|NCT01694108|P1|Participant Flow|BCG-vaccine|
120038|NCT01694108|O2|Outcome|Face-to-face|Randomized to receive information about the study by standard face-to-face consultation.
120039|NCT01694108|O1|Outcome|Telephone|Randomized to receive information about the study by telephone
120040|NCT01694108|O2|Outcome|Declining Mothers|Mothers who decided not to let their child participate in the study
120041|NCT01694108|O1|Outcome|Participating Mothers|Mothers who decided to let their child participate in the study
120042|NCT01694108|O2|Outcome|Control Children|No intervention
120043|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
120044|NCT01694108|O2|Outcome|Control Children|No intervention
120045|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
120046|NCT01694108|O2|Outcome|Control Children|No intervention
120047|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
120048|NCT01694108|O2|Outcome|Control Children|No intervention
120049|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
120050|NCT01694108|O2|Outcome|Control Children|No intervention
120051|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
120052|NCT01694108|O2|Outcome|Control Children|No intervention
120053|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
120054|NCT01694108|O2|Outcome|Control Children|No intervention
120055|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
120056|NCT01694108|O2|Outcome|Control Children|No intervention
120057|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
120058|NCT01694108|O2|Outcome|Control Children|No intervention
120059|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
120060|NCT01694108|O2|Outcome|Control Children|No intervention
120061|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
120062|NCT01694108|O2|Outcome|Control Children|No intervention
120063|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
120091|NCT01693900|B2|Baseline|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
120092|NCT01693900|B1|Baseline|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
120093|NCT01693900|P2|Participant Flow|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
120094|NCT01693900|P1|Participant Flow|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
120095|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
120143|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
Remifentanil: continuous infusion 0.4 mcg/kg/min
placebo (for midazolam): normal saline mimic to midazolam injection
placebo (for meperidine): normal saline mimic meperidine injection"
120684|NCT01690546|E1|Reported Event|BUP/VLNXT to VIVITROL|
120685|NCT01690299|B4|Baseline|Total|Total of all reporting groups
120096|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
120097|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
120098|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
120099|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
120100|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
120101|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
120102|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
120131|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
120103|NCT01693900|E2|Reported Event|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
120104|NCT01693900|E1|Reported Event|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
120105|NCT01693653|B3|Baseline|Total|Total of all reporting groups
120106|NCT01693653|B2|Baseline|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months
Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
120107|NCT01693653|B1|Baseline|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months
Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
120108|NCT01693653|P2|Participant Flow|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months
Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
120109|NCT01693653|P1|Participant Flow|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months
Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
120110|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months
Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
120111|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months
Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
120112|NCT01693653|E2|Reported Event|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months
Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
120113|NCT01693653|E1|Reported Event|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months
Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
120114|NCT01693484|B1|Baseline|Operative Calcaneus Fracture|Patients with indications for and electing to undergo operative repair of intra articular calcaneus fracture through extended lateral approach
120115|NCT01693484|P1|Participant Flow|Displaced Intra Articular Calcaneus Fracture|displaced intra articular calcaneus fracture with operative repair
120116|NCT01693484|O1|Outcome|ICG Administered|"The ICG dose (10 mg/4cc per image capture) will be administered in its entirety via push injection through IV access established for standard surgical procedure, followed by 10 cc Normal Saline bolus. This ICG dose will be administered twice, 1X prior to anesthesia, and 1X after the tourniquet on operative extremity has been removed for at least 15 minutes.
ICG (Indocyanine Green): Diagnostic drug used for visualisation of blood perfusion in various tissues.Administered intravenously, 2X: 1X prior to anesthesia, and 1X after tourniquet on operative extremity has been released for at least 15 minutes. When excited by laser light source, it subsequently emits at a near infrared frequency."
120117|NCT01693484|E1|Reported Event|Unanticipated Adverse Events Related to ICG|No adverse events related to administration ICG
120118|NCT01693367|B3|Baseline|Total|Total of all reporting groups
120119|NCT01693367|B2|Baseline|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
120120|NCT01693367|B1|Baseline|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
120121|NCT01693367|P2|Participant Flow|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
120122|NCT01693367|P1|Participant Flow|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
120123|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
120124|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
120125|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
120126|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
120127|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
120128|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
120129|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
120130|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
120195|NCT01692938|B3|Baseline|Total|Total of all reporting groups
120196|NCT01692938|B2|Baseline|Retinal Disease|
120132|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
120133|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
120134|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
120135|NCT01693367|E2|Reported Event|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
120136|NCT01693367|E1|Reported Event|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
120137|NCT01693185|B3|Baseline|Total|Total of all reporting groups
120138|NCT01693185|B2|Baseline|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
Midazolam: bolus injection
Meperidine: bolus injection for 30 sec 1.0 mg/kg
placebo (for remifentanil): normal saline mimic diluted remifentanil"
120139|NCT01693185|B1|Baseline|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
Remifentanil: continuous infusion 0.4 mcg/kg/min
placebo (for midazolam): normal saline mimic to midazolam injection
placebo (for meperidine): normal saline mimic meperidine injection"
120140|NCT01693185|P2|Participant Flow|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
Midazolam: bolus injection
Meperidine: bolus injection for 30 sec 1.0 mg/kg
placebo (for remifentanil): normal saline mimic diluted remifentanil"
120141|NCT01693185|P1|Participant Flow|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
Remifentanil: continuous infusion 0.4 mcg/kg/min
placebo (for midazolam): normal saline mimic to midazolam injection
placebo (for meperidine): normal saline mimic meperidine injection"
120142|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
Midazolam: bolus injection
Meperidine: bolus injection for 30 sec 1.0 mg/kg
placebo (for remifentanil): normal saline mimic diluted remifentanil"
120144|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
Midazolam: bolus injection
Meperidine: bolus injection for 30 sec 1.0 mg/kg
placebo (for remifentanil): normal saline mimic diluted remifentanil"
120145|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
Remifentanil: continuous infusion 0.4 mcg/kg/min
placebo (for midazolam): normal saline mimic to midazolam injection
placebo (for meperidine): normal saline mimic meperidine injection"
120146|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
Midazolam: bolus injection
Meperidine: bolus injection for 30 sec 1.0 mg/kg
placebo (for remifentanil): normal saline mimic diluted remifentanil"
120147|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
Remifentanil: continuous infusion 0.4 mcg/kg/min
placebo (for midazolam): normal saline mimic to midazolam injection
placebo (for meperidine): normal saline mimic meperidine injection"
120148|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
Midazolam: bolus injection
Meperidine: bolus injection for 30 sec 1.0 mg/kg
placebo (for remifentanil): normal saline mimic diluted remifentanil"
120149|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
Remifentanil: continuous infusion 0.4 mcg/kg/min
placebo (for midazolam): normal saline mimic to midazolam injection
placebo (for meperidine): normal saline mimic meperidine injection"
120150|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
Midazolam: bolus injection
Meperidine: bolus injection for 30 sec 1.0 mg/kg
placebo (for remifentanil): normal saline mimic diluted remifentanil"
120151|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
Remifentanil: continuous infusion 0.4 mcg/kg/min
placebo (for midazolam): normal saline mimic to midazolam injection
placebo (for meperidine): normal saline mimic meperidine injection"
120152|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
Midazolam: bolus injection
Meperidine: bolus injection for 30 sec 1.0 mg/kg
placebo (for remifentanil): normal saline mimic diluted remifentanil"
120153|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
Remifentanil: continuous infusion 0.4 mcg/kg/min
placebo (for midazolam): normal saline mimic to midazolam injection
placebo (for meperidine): normal saline mimic meperidine injection"
120154|NCT01693185|E2|Reported Event|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)
Midazolam: bolus injection
Meperidine: bolus injection for 30 sec 1.0 mg/kg
placebo (for remifentanil): normal saline mimic diluted remifentanil"
120155|NCT01693185|E1|Reported Event|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)
Remifentanil: continuous infusion 0.4 mcg/kg/min
placebo (for midazolam): normal saline mimic to midazolam injection
placebo (for meperidine): normal saline mimic meperidine injection"
120156|NCT01693029|B3|Baseline|Total|Total of all reporting groups
120157|NCT01693029|B2|Baseline|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa
US-licensed epoetin alfa: Solution for subcutaneous injection."
120197|NCT01692938|B1|Baseline|No Retinal Disease|
120198|NCT01692938|P2|Participant Flow|Retinal Disease|
120158|NCT01693029|B1|Baseline|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
120159|NCT01693029|P2|Participant Flow|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa
US-licensed epoetin alfa: Solution for subcutaneous injection."
120160|NCT01693029|P1|Participant Flow|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
120161|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa
US-licensed epoetin alfa: Solution for subcutaneous injection."
120162|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
120163|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa
US-licensed epoetin alfa: Solution for subcutaneous injection."
120164|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
120165|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa
US-licensed epoetin alfa: Solution for subcutaneous injection."
120166|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
120167|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa
US-licensed epoetin alfa: Solution for subcutaneous injection."
120168|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
120169|NCT01693029|E2|Reported Event|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa
US-licensed epoetin alfa: Solution for subcutaneous injection."
120170|NCT01693029|E1|Reported Event|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
120171|NCT01691885|B1|Baseline|Per Protocol Population|All participants received placebo or FF/VI 100/25 µg in either of the two treatment periods QD, each morning from a DPI. Treatment periods lasted 7 days up to a maximum of 14 days for each period. The two treatments were separated by a wash out period of 7 days, up to a maximum of 9 days.
120172|NCT01691885|P2|Participant Flow|FF/VI Then Placebo|Participants entering Treatment Period 1 received FF/VI 100/25 µg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period, participants entered Treatment Period 2 and received matching placebo QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
120173|NCT01691885|P1|Participant Flow|Placebo Then FF/VI|Participants entering Treatment Period 1 received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period participants entered Treatment Period 2 and received Fluticasone Furoate/Vilanerol (FF/VI) 100/25 micrograms (µg), QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
120174|NCT01691885|O2|Outcome|FF/VI|Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
120175|NCT01691885|O1|Outcome|Placebo|Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
120176|NCT01691885|E2|Reported Event|FF/VI|Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
120177|NCT01691885|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
120178|NCT01692951|B5|Baseline|Total|Total of all reporting groups
120179|NCT01692951|B4|Baseline|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120199|NCT01692938|P1|Participant Flow|No Retinal Disease|
120200|NCT01692938|O2|Outcome|Retinal Disease|
120180|NCT01692951|B3|Baseline|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120181|NCT01692951|B2|Baseline|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120182|NCT01692951|B1|Baseline|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120183|NCT01692951|P4|Participant Flow|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120184|NCT01692951|P3|Participant Flow|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120185|NCT01692951|P2|Participant Flow|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120221|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120186|NCT01692951|P1|Participant Flow|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120187|NCT01692951|O4|Outcome|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120188|NCT01692951|O3|Outcome|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120189|NCT01692951|O2|Outcome|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120190|NCT01692951|O1|Outcome|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120191|NCT01692951|E4|Reported Event|Control Matched to Squamous Cell|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120192|NCT01692951|E3|Reported Event|Lung Squamous Cell Carcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120193|NCT01692951|E2|Reported Event|Control Matched to Adenocarcinoma|"Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120194|NCT01692951|E1|Reported Event|Lung Adenocarcinoma Patients|"Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.
serum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank"
120204|NCT01692938|E2|Reported Event|Retinal Disease|
120205|NCT01692938|E1|Reported Event|No Retinal Disease|
120206|NCT01692782|B4|Baseline|Total|Total of all reporting groups
120207|NCT01692782|B3|Baseline|Placebo|"4 capsules of placebo
Placebo: Placebo once daily"
120208|NCT01692782|B2|Baseline|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 8mg once daily"
120209|NCT01692782|B1|Baseline|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily"
120210|NCT01692782|P3|Participant Flow|Placebo|"4 capsules of placebo
Placebo: Placebo once daily"
120211|NCT01692782|P2|Participant Flow|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120212|NCT01692782|P1|Participant Flow|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120213|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo
Placebo: Placebo once daily"
120214|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120215|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120216|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo
Placebo: Placebo once daily"
120217|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120218|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120219|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo
Placebo: Placebo once daily"
120220|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120222|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo
Placebo: Placebo once daily"
120223|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120224|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120225|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo
Placebo: Placebo once daily"
120226|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120227|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120228|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo
Placebo: Placebo once daily"
120229|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120230|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120231|NCT01692782|E3|Reported Event|Placebo|"4 capsules of placebo
Placebo: Placebo once daily"
120232|NCT01692782|E2|Reported Event|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120233|NCT01692782|E1|Reported Event|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily"
120234|NCT01692691|B1|Baseline|Number of Participants|Dacarbazine Carmustine
120235|NCT01692691|P1|Participant Flow|Dacarbazine Carmustine|All patients received chemotherapy with Dacarbazine and Carmustine
120236|NCT01692691|O1|Outcome|Response Rate|Dacarbazine Carmustine
120237|NCT01692691|O1|Outcome|Progression Free Survival at 8 Weeks|Dacarbazine + Carmustine
120238|NCT01692691|E1|Reported Event|Number of Participants|Dacarbazine Carmustine
120239|NCT01692626|B1|Baseline|Investigational Cream/Placebo Cream|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.
Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
120240|NCT01692626|P2|Participant Flow|Right Side Investigational Cream / Placebo on Left Side|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.
Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
120241|NCT01692626|P1|Participant Flow|Left Side Investigational Cream/Placebo Cream on Right Side|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.
Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
120242|NCT01692626|O2|Outcome|The Right Side the Pimecrolimus Cream|The right side of the face that the pimecrolimus cream was applied.
120243|NCT01692626|O1|Outcome|Left sidePimecrolimus Cream|The left side of the face that the Pimecrolimus Cream was applied.
120244|NCT01692626|E1|Reported Event|Investigational Cream/Placebo Cream|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.
Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
120245|NCT01692340|B4|Baseline|Total|Total of all reporting groups
120246|NCT01692340|B3|Baseline|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120247|NCT01692340|B2|Baseline|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120248|NCT01692340|B1|Baseline|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120249|NCT01692340|P3|Participant Flow|Istotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120250|NCT01692340|P2|Participant Flow|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120251|NCT01692340|P1|Participant Flow|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120252|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120253|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120254|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120255|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120256|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120257|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120258|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120259|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120260|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120261|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120262|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120263|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120264|NCT01692340|E3|Reported Event|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120265|NCT01692340|E2|Reported Event|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120266|NCT01692340|E1|Reported Event|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
120267|NCT01692301|B3|Baseline|Total|Total of all reporting groups
120268|NCT01692301|B2|Baseline|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120269|NCT01692301|B1|Baseline|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120270|NCT01692301|P2|Participant Flow|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120271|NCT01692301|P1|Participant Flow|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120272|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120273|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120319|NCT01691781|P1|Participant Flow|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
120320|NCT01691781|O2|Outcome|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
121146|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
120274|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120275|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120276|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120277|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120278|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120279|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120280|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120281|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120385|NCT01691534|B8|Baseline|Total|Total of all reporting groups
120386|NCT01691534|B7|Baseline|Rifafour|Rifafour on Days 1 to 14, dosed by weight
120282|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120283|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120284|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120285|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120286|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120287|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120288|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120289|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120290|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120291|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120292|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120293|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120294|NCT01692301|E2|Reported Event|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
120387|NCT01691534|B6|Baseline|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
120388|NCT01691534|B5|Baseline|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
120295|NCT01692301|E1|Reported Event|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
120296|NCT01691794|B4|Baseline|Total|Total of all reporting groups
120297|NCT01691794|B3|Baseline|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120298|NCT01691794|B2|Baseline|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120299|NCT01691794|B1|Baseline|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120300|NCT01691794|P3|Participant Flow|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120321|NCT01691781|O1|Outcome|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
120322|NCT01691781|O2|Outcome|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
120301|NCT01691794|P2|Participant Flow|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120302|NCT01691794|P1|Participant Flow|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120303|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120304|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120305|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120306|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120307|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120308|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120309|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120310|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120389|NCT01691534|B4|Baseline|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120394|NCT01691534|P6|Participant Flow|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
120311|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120312|NCT01691794|E3|Reported Event|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120313|NCT01691794|E2|Reported Event|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120314|NCT01691794|E1|Reported Event|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
120315|NCT01691781|B3|Baseline|Total|Total of all reporting groups
120316|NCT01691781|B2|Baseline|Normals|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
120317|NCT01691781|B1|Baseline|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
120318|NCT01691781|P2|Participant Flow|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
136545|NCT01627002|O1|Outcome|Part B 3.0 mg PA401|
120325|NCT01691781|O1|Outcome|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
120326|NCT01691781|E2|Reported Event|Normal|Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
120327|NCT01691781|E1|Reported Event|Primary Hyperparathyroidism|Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
120328|NCT01691690|B3|Baseline|Total|Total of all reporting groups
120329|NCT01691690|B2|Baseline|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.
Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
120330|NCT01691690|B1|Baseline|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
120331|NCT01691690|P2|Participant Flow|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.
Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
120332|NCT01691690|P1|Participant Flow|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
120333|NCT01691690|O2|Outcome|Saline Placebo Infused Intraoperatively|"For this arm Morphine will be administered to manage pain.
Normal Saline Flush: Saline placebo will be infused intraoperatively.
Midazolam: Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.
Sevoflurane: Sevoflurane for anesthesia induction.
Nitrous Oxide/Oxygen: Combination of NO2 & O2 for anesthesia induction.
Propofol: Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.
Morphine: Morphine 0.1 mg/kg given prior to intubation.
Ondansetron: Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.
Dexamethasone: Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis."
120390|NCT01691534|B3|Baseline|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120391|NCT01691534|B2|Baseline|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14"
120334|NCT01691690|O1|Outcome|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction..
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg).
Midazolam: Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.
Sevoflurane: Sevoflurane for anesthesia induction.
Nitrous Oxide/Oxygen: Combination of NO2 & O2 for anesthesia induction.
Propofol: Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.
Morphine: Morphine 0.1 mg/kg given prior to intubation.
Ondansetron: Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.
Dexamethasone: Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis."
120335|NCT01691690|O2|Outcome|Saline Placebo Infused Intraoperatively|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.
Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
120336|NCT01691690|O1|Outcome|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
120337|NCT01691690|O2|Outcome|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.
Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
120338|NCT01691690|O1|Outcome|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
121147|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
120339|NCT01691690|E2|Reported Event|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.
Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
120340|NCT01691690|E1|Reported Event|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
120341|NCT01691612|B1|Baseline|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
120342|NCT01691612|P1|Participant Flow|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
120343|NCT01691612|O1|Outcome|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
120344|NCT01691612|O1|Outcome|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
120345|NCT01691612|O1|Outcome|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
120392|NCT01691534|B1|Baseline|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120393|NCT01691534|P7|Participant Flow|Rifafour|Rifafour on Days 1 to 14, dosed by weight
120346|NCT01691612|O1|Outcome|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
120347|NCT01691612|E1|Reported Event|D. Pteronyssinus Allergens|"Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later"
120348|NCT01691560|B5|Baseline|Total|Total of all reporting groups
120349|NCT01691560|B4|Baseline|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
120350|NCT01691560|B3|Baseline|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
120351|NCT01691560|B2|Baseline|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120352|NCT01691560|B1|Baseline|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120353|NCT01691560|P4|Participant Flow|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
120354|NCT01691560|P3|Participant Flow|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
120355|NCT01691560|P2|Participant Flow|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120356|NCT01691560|P1|Participant Flow|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 parts per million (ppm) fluoride as sodium monofluorophosphate
120357|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120358|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
120359|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
120360|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120361|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120362|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
120363|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
120364|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120365|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120366|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
120367|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
120368|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120369|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120370|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
120371|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
120372|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120373|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120374|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
120375|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
120376|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120377|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120378|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
120379|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
120380|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120381|NCT01691560|E4|Reported Event|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
120382|NCT01691560|E3|Reported Event|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
120383|NCT01691560|E2|Reported Event|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120384|NCT01691560|E1|Reported Event|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
120395|NCT01691534|P5|Participant Flow|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
120396|NCT01691534|P4|Participant Flow|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120397|NCT01691534|P3|Participant Flow|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120398|NCT01691534|P2|Participant Flow|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14"
120399|NCT01691534|P1|Participant Flow|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120400|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
120401|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
120402|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
120403|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120404|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120405|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14"
120406|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120407|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
120408|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
120409|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
120410|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
136546|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
120411|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120412|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14"
120413|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120414|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
120415|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-1414
120416|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
120417|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120418|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120419|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14"
120420|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120421|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
120422|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
120423|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
120424|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120425|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120426|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14"
120427|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120428|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
120429|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
120430|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
120431|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120530|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
120432|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120433|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14"
120434|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120435|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
120436|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
120437|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
120438|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120439|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120440|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14"
120441|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120442|NCT01691534|E7|Reported Event|Rifafour|Rifafour on Days 1 to 14, dosed by weight
120443|NCT01691534|E6|Reported Event|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
120444|NCT01691534|E5|Reported Event|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
120445|NCT01691534|E4|Reported Event|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120446|NCT01691534|E3|Reported Event|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
121148|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
120447|NCT01691534|E2|Reported Event|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14"
120448|NCT01691534|E1|Reported Event|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14
PA-824 (PA): 200 mg on Days 1 to 14
pyrazinamide (Z): 1500 mg on Days 1 to 14
clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
120449|NCT01691521|B4|Baseline|Total|Total of all reporting groups
120450|NCT01691521|B3|Baseline|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120451|NCT01691521|B2|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120452|NCT01691521|B1|Baseline|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120453|NCT01691521|P3|Participant Flow|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120454|NCT01691521|P2|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 milligrams (mg) IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120455|NCT01691521|P1|Participant Flow|Placebo|Participants received placebo intravenously (IV) plus placebo subcutaneously (SC) every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120456|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
120457|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120529|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
120458|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120459|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
120460|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120461|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120462|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
120463|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120464|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120465|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
120466|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120467|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120468|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120469|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120470|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120471|NCT01691521|E3|Reported Event|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
120472|NCT01691521|E2|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120473|NCT01691521|E1|Reported Event|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120474|NCT01691508|B3|Baseline|Total|Total of all reporting groups
120475|NCT01691508|B2|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120476|NCT01691508|B1|Baseline|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120477|NCT01691508|P2|Participant Flow|Mepolizumab 100mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120478|NCT01691508|P1|Participant Flow|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120479|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120480|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120481|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120482|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120483|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
121149|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
120484|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120485|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120486|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120487|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120488|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120489|NCT01691508|E2|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120490|NCT01691508|E1|Reported Event|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
120491|NCT01691482|B1|Baseline|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
120492|NCT01691482|P2|Participant Flow|Ipratropium Then A/S in TP1; A/S Then Ipratropium in TP2|Participants received Ipratropium (4 puffs; 20 µg per puff) followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) (A/S) via a MDI in TP1, then A/S followed by ipratropium at the same doses via an MDI in TP2.
120493|NCT01691482|P1|Participant Flow|A/S Then Ipratropium in TP1; Ipratropium Then A/S in TP2|Participants received albuterol (4 puffs; 90 micrograms [µg] per puff)/salbutamol (A/S) (4 puffs; 100 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via a metered-dose inhaler (MDI) during treatment period 1 (TP1) then, ipratropium followed by A/S at the same doses via an MDI in treatment period 2 (TP2).
120494|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
120495|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
120582|NCT01691248|P2|Participant Flow|Placebo|Placebo tablet once daily for no longer than 40 days
120496|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
120497|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
120498|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
120499|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
120500|NCT01691482|O2|Outcome|Ipratropium Follwed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
120501|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
120502|NCT01691482|O2|Outcome|Ipratropium Follwed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
120503|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
120504|NCT01691482|O1|Outcome|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
120505|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
120506|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
120507|NCT01691482|E1|Reported Event|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
120508|NCT01691339|B5|Baseline|Total|Total of all reporting groups
120509|NCT01691339|B4|Baseline|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
120510|NCT01691339|B3|Baseline|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
120511|NCT01691339|B2|Baseline|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
120512|NCT01691339|B1|Baseline|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
120513|NCT01691339|P4|Participant Flow|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
120514|NCT01691339|P3|Participant Flow|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
120515|NCT01691339|P2|Participant Flow|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
120516|NCT01691339|P1|Participant Flow|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
120517|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
120518|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
120519|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
120520|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
120521|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
120522|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
120523|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
120524|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
120525|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
120526|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
120527|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
120528|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
120531|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
120532|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
120533|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
120534|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
120535|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
120536|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
120537|NCT01691339|E4|Reported Event|Fluzone High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
120538|NCT01691339|E3|Reported Event|Fluzone Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
120539|NCT01691339|E2|Reported Event|Fluzone Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
120540|NCT01691339|E1|Reported Event|Fluzone Vaccine (Group 1)|'Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly'
120541|NCT01691326|B3|Baseline|Total|Total of all reporting groups
120542|NCT01691326|B2|Baseline|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
120543|NCT01691326|B1|Baseline|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
120544|NCT01691326|P2|Participant Flow|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses 0.5 mL of Fluzone vaccine
120545|NCT01691326|P1|Participant Flow|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
120546|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
120547|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
120548|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
120549|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
120550|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
120551|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
120552|NCT01691326|O2|Outcome|3 to < 9 Years Age Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
120553|NCT01691326|O1|Outcome|6 to < 36 Months Age Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
120554|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
120555|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
120556|NCT01691326|E2|Reported Event|3 to < 9 Years Age Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
120557|NCT01691326|E1|Reported Event|6 to < 36 Months Age Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
120558|NCT01691313|B5|Baseline|Total|Total of all reporting groups
120559|NCT01691313|B4|Baseline|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg
Vanoxerine: single oral dose"
120560|NCT01691313|B3|Baseline|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg
Vanoxerine: single oral dose"
120561|NCT01691313|B2|Baseline|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg
Vanoxerine: single oral dose"
120562|NCT01691313|B1|Baseline|Placebo|"placebo to match vanoxerine oral capsule
Placebo: single oral dose"
120563|NCT01691313|P4|Participant Flow|Vanoxerine 400mg|vanoxerine 400 mg (4x100mg oral capsules) single oral dose
120564|NCT01691313|P3|Participant Flow|Vanoxerine 300mg|vanoxerine 300 mg (3x 100 mg oral capsules) single oral dose
120565|NCT01691313|P2|Participant Flow|Placebo|"placebo to match vanoxerine oral capsule
Placebo: single oral dose"
120566|NCT01691313|P1|Participant Flow|Vanoxerine 200mg|"vanoxerine 200 mg (2x 100mg oral capsules)
Vanoxerine: single oral dose"
120567|NCT01691313|O4|Outcome|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg
Vanoxerine: single oral dose"
120568|NCT01691313|O3|Outcome|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg
Vanoxerine: single oral dose"
120569|NCT01691313|O2|Outcome|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg
Vanoxerine: single oral dose"
120570|NCT01691313|O1|Outcome|Placebo|"placebo to match vanoxerine oral capsule
Placebo: single oral dose"
120571|NCT01691313|O4|Outcome|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg
Vanoxerine: single oral dose"
120572|NCT01691313|O3|Outcome|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg
Vanoxerine: single oral dose"
120573|NCT01691313|O2|Outcome|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg
Vanoxerine: single oral dose"
120574|NCT01691313|O1|Outcome|Placebo|"placebo to match vanoxerine oral capsule
Placebo: single oral dose"
120575|NCT01691313|E4|Reported Event|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg
Vanoxerine: single oral dose"
120576|NCT01691313|E3|Reported Event|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg
Vanoxerine: single oral dose"
120577|NCT01691313|E2|Reported Event|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg
Vanoxerine: single oral dose"
120578|NCT01691313|E1|Reported Event|Placebo|"placebo to match vanoxerine oral capsule
Placebo: single oral dose"
120579|NCT01691248|B3|Baseline|Total|Total of all reporting groups
120580|NCT01691248|B2|Baseline|Placebo|Placebo tablet once daily for no longer than 40 days
120581|NCT01691248|B1|Baseline|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
120583|NCT01691248|P1|Participant Flow|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
120584|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
120585|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
120586|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
120587|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
120588|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
120589|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
120590|NCT01691248|E2|Reported Event|Placebo|Placebo tablet once daily for no longer than 40 days
120591|NCT01691248|E1|Reported Event|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
120592|NCT01691092|B1|Baseline|Ketamine|"All subjects will receive ketamine
Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
120593|NCT01691092|P1|Participant Flow|Ketamine|"All subjects will receive ketamine
Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
120594|NCT01691092|O1|Outcome|Ketamine|"All subjects will receive ketamine
Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
120595|NCT01691092|E1|Reported Event|Ketamine|"All subjects will receive ketamine
Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
120596|NCT01691014|B5|Baseline|Total|Total of all reporting groups
120597|NCT01691014|B4|Baseline|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120598|NCT01691014|B3|Baseline|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120599|NCT01691014|B2|Baseline|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120600|NCT01691014|B1|Baseline|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120601|NCT01691014|P4|Participant Flow|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
121070|NCT01689207|P2|Participant Flow|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
120602|NCT01691014|P3|Participant Flow|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120603|NCT01691014|P2|Participant Flow|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120604|NCT01691014|P1|Participant Flow|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120605|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120606|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120607|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120608|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120609|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120610|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120611|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120612|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120613|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120614|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120615|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120616|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120617|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120618|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120619|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120620|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120621|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120622|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120623|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120768|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120624|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120625|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120626|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120627|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120628|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120629|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120630|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120631|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120632|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120633|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120634|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120635|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120636|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120637|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120638|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120639|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120640|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120641|NCT01691014|E4|Reported Event|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120642|NCT01691014|E3|Reported Event|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120643|NCT01691014|E2|Reported Event|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
120644|NCT01691014|E1|Reported Event|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
120645|NCT01690923|B1|Baseline|Current CPAP Users|"Nasal mask; Pillows mask
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)
Pillows mask : Nasal pillows mask (Swift FX)"
120646|NCT01690923|P2|Participant Flow|Pillows Mask First, Then Nasal Mask|"Sequence 2: Pillows mask first, then Nasal mask
[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]"
120647|NCT01690923|P1|Participant Flow|Nasal Mask First, Then Pillows Mask|"Sequence 1: Nasal mask first, then Pillows mask
[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]"
120648|NCT01690923|O1|Outcome|Current CPAP Users|"Nasal mask; Pillows mask
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)
Pillows mask : Nasal pillows mask (Swift FX)"
120649|NCT01690923|O1|Outcome|Current CPAP Users|"Nasal mask; Pillows mask
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)
Pillows mask : Nasal pillows mask (Swift FX)"
120650|NCT01690923|E1|Reported Event|Current CPAP Users|"Nasal mask; Pillows mask
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)
Pillows mask : Nasal pillows mask (Swift FX)"
120651|NCT01690663|B5|Baseline|Total|Total of all reporting groups
120652|NCT01690663|B4|Baseline|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25%
Dexamethasone"
120653|NCT01690663|B3|Baseline|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone"
120654|NCT01690663|B2|Baseline|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone"
120655|NCT01690663|B1|Baseline|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25%
normal saline: placebo"
120656|NCT01690663|P4|Participant Flow|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25%
Dexamethasone"
120657|NCT01690663|P3|Participant Flow|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone"
120658|NCT01690663|P2|Participant Flow|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone"
120659|NCT01690663|P1|Participant Flow|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25%
normal saline: placebo"
120660|NCT01690663|O4|Outcome|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25%
Dexamethasone"
120661|NCT01690663|O3|Outcome|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone"
120662|NCT01690663|O2|Outcome|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone"
120663|NCT01690663|O1|Outcome|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25%
normal saline: placebo"
120664|NCT01690663|O4|Outcome|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25%
Dexamethasone"
120665|NCT01690663|O3|Outcome|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone"
120666|NCT01690663|O2|Outcome|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone"
120667|NCT01690663|O1|Outcome|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25%
normal saline: placebo"
120668|NCT01690663|E4|Reported Event|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25%
Dexamethasone"
120669|NCT01690663|E3|Reported Event|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone"
120670|NCT01690663|E2|Reported Event|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone"
120671|NCT01690663|E1|Reported Event|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25%
normal saline: placebo"
120672|NCT01690546|B1|Baseline|BUP/VLNXT to VIVITROL|
120673|NCT01690546|P1|Participant Flow|BUP/VLNXT to VIVITROL|
120674|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
120675|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
120676|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
120677|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
120678|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
120679|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
120680|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
120681|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
120686|NCT01690299|B3|Baseline|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120687|NCT01690299|B2|Baseline|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120688|NCT01690299|B1|Baseline|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120689|NCT01690299|P6|Participant Flow|Etanercept/Apremilast|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants discontinued etanercept and were switched to apremilast 30mg PO BID through week 104.
120690|NCT01690299|P5|Participant Flow|Apremilast/Apremilast|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID only through week 104.
120691|NCT01690299|P4|Participant Flow|Placebo/Apremilast|Participants received identically matching placebo tablets by PO, BID and SC saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg apremilast PO BID and remained on this dose through week 104.
120692|NCT01690299|P3|Participant Flow|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120693|NCT01690299|P2|Participant Flow|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120694|NCT01690299|P1|Participant Flow|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120695|NCT01690299|O3|Outcome|Etanercept/Apremilast|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
120696|NCT01690299|O2|Outcome|Apremilast/Apremilast|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
120697|NCT01690299|O1|Outcome|Placebo/Apremilast|Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
120698|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120699|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120843|NCT01690000|E2|Reported Event|Placebo|Identical placebo given nightly for 12 months
120700|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120701|NCT01690299|O3|Outcome|Etanercept/Apremilast|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
120702|NCT01690299|O2|Outcome|Apremilast/Apremilast|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
120703|NCT01690299|O1|Outcome|Placebo/Apremilast|Participants received identically matching placebo tablets PO BID and SC saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
120704|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120705|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120706|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120707|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120708|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120709|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120710|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120711|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
121071|NCT01689207|P1|Participant Flow|Part A: Placebo|Placebo
120712|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120713|NCT01690299|O3|Outcome|Etanercept 50mg Plus Placebo Tablet|Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120714|NCT01690299|O2|Outcome|Apremilast 30mg Plus Placebo Injection|Apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120715|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120716|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120717|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120718|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120719|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120720|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120721|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120722|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
120723|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120724|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120725|NCT01690299|O2|Outcome|Etanercept 50mg Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
120726|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120727|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120728|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120769|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120729|NCT01690299|E6|Reported Event|Etanercept/APR 30mg (Apremilast Exposure Phase) Weeks 16-104|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
120730|NCT01690299|E5|Reported Event|APR/APR 30 mg (Apremilast Exposure Phase) Weeks 0-104|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
120731|NCT01690299|E4|Reported Event|Placebo/APR 30mg (Apremilast Exposure Phase) Weeks 16-104|Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
120732|NCT01690299|E3|Reported Event|Etanercept Plus Placebo Tablets (Week 0-16)|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120733|NCT01690299|E2|Reported Event|Apremilast Plus Placebo Injection (Week 0-16)|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120734|NCT01690299|E1|Reported Event|Placebo (Week 0-16)|Participants received placebo tablets PO BID and 2-1 milliliter (ml) SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
120735|NCT01690273|B4|Baseline|Total|Total of all reporting groups
120736|NCT01690273|B3|Baseline|Elastic Resistance Exercise in AS|"stretching and elastic resistance exercises
stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
120737|NCT01690273|B2|Baseline|Stretching in AS|"stretching exercises
stretching exercise: 30 minutes, twice a week for sixteen weeks."
120738|NCT01690273|B1|Baseline|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
120739|NCT01690273|P3|Participant Flow|Mobility and Elastic Resistance Exercise in AS|"mobility, plus elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120740|NCT01690273|P2|Participant Flow|Mobility in Ankylosing Spondylitis|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120741|NCT01690273|P1|Participant Flow|Ankylosing Spondylitis Control|control group, no intervention in ankylosing spondylitis patients
120742|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120743|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120744|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120745|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120746|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120747|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120748|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120749|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120750|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120751|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120752|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120753|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120754|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120755|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120756|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120757|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120758|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120759|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120760|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120761|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120762|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120763|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120764|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120765|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120766|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120767|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120770|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120771|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120772|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120773|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120774|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120775|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120776|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120777|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
120778|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
120779|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week for sixteen weeks."
120780|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
120781|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120782|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120783|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group with AS patients and no exercise
120784|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
120785|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises
mobility exercise: 30 minutes, twice a week"
120786|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group with AS patients and no exercise
120787|NCT01690273|E3|Reported Event|Elastic Resistance Exercise in AS|"stretching and elastic resistance exercises
stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
120788|NCT01690273|E2|Reported Event|Stretching in AS|"stretching exercises
stretching exercise: 30 minutes, twice a week for sixteen weeks."
120789|NCT01690273|E1|Reported Event|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
120790|NCT01690117|B3|Baseline|Total|Total of all reporting groups
120791|NCT01690117|B2|Baseline|Control Group|"usual care
The informal caregivers of the control group only receive the standard supply of health care Services."
120792|NCT01690117|B1|Baseline|DeREACH-program|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120793|NCT01690117|P2|Participant Flow|Control Group|"usual care
The informal caregivers of the control group only receive the standard supply of health care Services."
120794|NCT01690117|P1|Participant Flow|DeREACH-program|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120795|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
120796|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120797|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
120798|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120799|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
120800|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120801|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
120802|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120803|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
120804|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120805|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
120806|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120807|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
120842|NCT01690000|O1|Outcome|Melatonin1+3|"1+3 mg melatonin nightly
Melatonin: 1 or 3 mg of melatonin PO each night for 12 months"
120808|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120809|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
120810|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120811|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
120812|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120813|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
120814|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120815|NCT01690117|O2|Outcome|Control Group|"usual care
The informal caregivers of the control group only receive the standard supply of health care Services."
120816|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120817|NCT01690117|O2|Outcome|Control Group|"usual care
The informal caregivers of the control group only receive the standard supply of health care Services."
120818|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120819|NCT01690117|O2|Outcome|Control Group|"usual care
The informal caregivers of the control group only receive the standard supply of health care Services."
120820|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120821|NCT01690117|O2|Outcome|Control Group|"usual care
The informal caregivers of the control group only receive the standard supply of health care Services."
120822|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120823|NCT01690117|O2|Outcome|Control Group|"usual care
The informal caregivers of the control group only receive the standard supply of health care Services."
120824|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120825|NCT01690117|O2|Outcome|Control Group|"usual care
The informal caregivers of the control group only receive the standard supply of health care Services."
120826|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program
DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
120827|NCT01690117|E2|Reported Event|Control Group|Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
120828|NCT01690117|E1|Reported Event|Intervention Group|Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
120829|NCT01690052|B1|Baseline|All Participants|"Two interventions were assembled:
For the first intervention, the SEQUENCE was cevimeline (30mg three times a day) for 4 weeks and then Pilocarpine (5 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week.
For the second intervention, the SEQUENCE was Pilocarpine (5mg three times a day) or 4 weeks and then Cevimeline (30 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week."
120830|NCT01690052|P2|Participant Flow|Pilocarpine First, Then Cevimeline|Pilocarpine First then Cevimeline: Pilocarpine (5 mg three times a day) for 4 weeks (first intervention period) and then Cevimeline (30mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
120831|NCT01690052|P1|Participant Flow|Cevimeline First, Then Pilocarpine|Cevimeline First then Pilocarpine: Cevimeline (30mg three times a day) for 4 weeks (First intervention period) and then pilocarpine (5 mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
120832|NCT01690052|O2|Outcome|Pilocarpine|Pilocarpine 5 mg administered three times a day in either first intervention period or second intervention period
120833|NCT01690052|O1|Outcome|Cevimeline|Cevimeline 30mg administered three times a day in first intervention period or second intervention period for 4 weeks.
120834|NCT01690052|E2|Reported Event|Pilocarpine Then Cevimeline (Intervention 2)|Pilocarpine then cevimeline One week washout period
120835|NCT01690052|E1|Reported Event|Cevimeline Then Pilocarpine (Intervention 1)|Cevimeline then pilocarpine One week washout period
120836|NCT01690000|B3|Baseline|Total|Total of all reporting groups
120837|NCT01690000|B2|Baseline|Placebo|Identical placebo given nightly for 12 months
120838|NCT01690000|B1|Baseline|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
120839|NCT01690000|P2|Participant Flow|Placebo|Identical placebo given nightly for 12 months
120840|NCT01690000|P1|Participant Flow|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
120841|NCT01690000|O2|Outcome|Placebo|"Identical placebo given nightly
Melatonin: 1 or 3 mg of melatonin PO each night for 12 months"
121481|NCT01687478|B3|Baseline|Total|Total of all reporting groups
120844|NCT01690000|E1|Reported Event|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
120845|NCT01689857|B3|Baseline|Total|Total of all reporting groups
120846|NCT01689857|B2|Baseline|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
120847|NCT01689857|B1|Baseline|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
120848|NCT01689857|P2|Participant Flow|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
120849|NCT01689857|P1|Participant Flow|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
120850|NCT01689857|O2|Outcome|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
120851|NCT01689857|O1|Outcome|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
120852|NCT01689857|E2|Reported Event|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
120853|NCT01689857|E1|Reported Event|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
120854|NCT01689649|B1|Baseline|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
120855|NCT01689649|P1|Participant Flow|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
120856|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
120857|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
120886|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120858|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
120859|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
120860|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
120861|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
120862|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
120863|NCT01689649|E1|Reported Event|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral (PO) in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
120864|NCT01689532|B3|Baseline|Total|Total of all reporting groups
120865|NCT01689532|B2|Baseline|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120866|NCT01689532|B1|Baseline|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120867|NCT01689532|P2|Participant Flow|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120868|NCT01689532|P1|Participant Flow|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120869|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120870|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120871|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120872|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
122388|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
120873|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120874|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120875|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120876|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120877|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120878|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120879|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120880|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120881|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120882|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120883|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120884|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120885|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
121145|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
120887|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120888|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120889|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120890|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120891|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120892|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120893|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120894|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120895|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120896|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120897|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120898|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120899|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120900|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120901|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120902|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120903|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120904|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120905|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
121106|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
120906|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120907|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120908|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120909|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120910|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120911|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120912|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120913|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120914|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120915|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120916|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120917|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120918|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120919|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120920|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120921|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120922|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120923|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120924|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120925|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120926|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120927|NCT01689532|E2|Reported Event|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
120928|NCT01689532|E1|Reported Event|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
120929|NCT01689519|B3|Baseline|Total|Total of all reporting groups
120930|NCT01689519|B2|Baseline|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120931|NCT01689519|B1|Baseline|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120932|NCT01689519|P2|Participant Flow|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120933|NCT01689519|P1|Participant Flow|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120934|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120935|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
121107|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
120936|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120937|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120938|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120939|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120940|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120941|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120942|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120943|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120944|NCT01689519|E2|Reported Event|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120977|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
120945|NCT01689519|E1|Reported Event|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
120946|NCT01689441|B3|Baseline|Total|Total of all reporting groups
120947|NCT01689441|B2|Baseline|Placebo|"Normal saline 2cc IV x 1
Placebo"
120948|NCT01689441|B1|Baseline|Calcitriol|"Calcitriol 2mcg IV x 1
Calcitriol"
120949|NCT01689441|P2|Participant Flow|Placebo|"Normal saline 2cc IV x 1
Placebo"
120950|NCT01689441|P1|Participant Flow|Calcitriol|"Calcitriol 2mcg IV x 1
Calcitriol"
120951|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1
Placebo"
120952|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1
Calcitriol"
120953|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1
Placebo"
120954|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1
Calcitriol"
120955|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1
Placebo"
120956|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1
Calcitriol"
120957|NCT01689441|E2|Reported Event|Placebo|"Normal saline 2cc IV x 1
Placebo"
120958|NCT01689441|E1|Reported Event|Calcitriol|"Calcitriol 2mcg IV x 1
Calcitriol"
120959|NCT01689363|B1|Baseline|Total Study Population|Subjects received four intradermal injections of study drug (two injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL), one injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL), one injection of 0.02 mL saline) in a random order at four locations on the subjects’ forearms.
120960|NCT01689363|P8|Participant Flow|P, H, N, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
120961|NCT01689363|P7|Participant Flow|P, H, H, N|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm
120962|NCT01689363|P6|Participant Flow|N, H, P, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
120963|NCT01689363|P5|Participant Flow|N, H, H, P|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm
120964|NCT01689363|P4|Participant Flow|H, P, N, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
121041|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
120965|NCT01689363|P3|Participant Flow|H, P, H, N|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm
120966|NCT01689363|P2|Participant Flow|H, N, P, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
120967|NCT01689363|P1|Participant Flow|H, N, H, P|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm
120968|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
120969|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
120970|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
120971|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
120972|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
120973|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
120974|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
120975|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
120976|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
120978|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
120979|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
120980|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
120981|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
120982|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
120983|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
120984|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
120985|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
120986|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
120987|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
120988|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
120989|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
120990|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
120991|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
120992|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
120993|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
120994|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
120995|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
120996|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
120997|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
120998|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
120999|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
121000|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
121001|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
121002|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
121003|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
121004|NCT01689363|O1|Outcome|Intent-to-Treat Population (ITT)|Subjects who have been randomized
121005|NCT01689363|O1|Outcome|Per-Protocol Population (PPP)|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments
121006|NCT01689363|E4|Reported Event|All Arms|Cannot identify which study drug may be associated with the ADE because the subject received all four injections almost at the same time
121007|NCT01689363|E3|Reported Event|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
121008|NCT01689363|E2|Reported Event|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
121009|NCT01689363|E1|Reported Event|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
121010|NCT01689350|B3|Baseline|Total|Total of all reporting groups
121011|NCT01689350|B2|Baseline|Experimental Group|47 cases in experimental group were genotyped as extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM）with initial dose of CPA as 0.2g, 0.4g and 0.6g per week by injection, respectively.
121012|NCT01689350|B1|Baseline|Control Group|45 cases in control group received traditional therapy that the initial dose of cyclophosphamide (CPA) was 0.2-0.6g/week injection according to clinical experience.
121013|NCT01689350|P2|Participant Flow|Control Group|Cyclophosphamide (CPA) medication was according to the traditional experiences.
121014|NCT01689350|P1|Participant Flow|Experimental Group|Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.
121015|NCT01689350|O2|Outcome|Control Group|CPA medication was according to the traditional experiences.
121016|NCT01689350|O1|Outcome|Experimental Group|CPA medication was according to the genotypes of SLE patients.
121017|NCT01689350|O2|Outcome|Control Group|CPA medication was according to the traditional experiences.
121018|NCT01689350|O1|Outcome|Experimental Group|CPA medication was according to the genotypes of SLE patients.
121019|NCT01689350|E2|Reported Event|Control Group|Cyclophosphamide (CPA) medication was according to the traditional experiences.
121020|NCT01689350|E1|Reported Event|Experimental Group|Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.
121021|NCT01689337|B1|Baseline|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
121022|NCT01689337|P1|Participant Flow|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
121023|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
121024|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
121025|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
121026|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
121027|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
121028|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
121029|NCT01689337|O1|Outcome|AS902330, 100 mcg|AS902330 was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
121030|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
121031|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
121032|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
121033|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
121034|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
121035|NCT01689337|E1|Reported Event|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
121036|NCT01689324|B1|Baseline|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
121037|NCT01689324|P1|Participant Flow|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
121038|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
121039|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
121040|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
121042|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
121043|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
121044|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
121045|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
121046|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
121047|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
121048|NCT01689324|E1|Reported Event|Study Group|Participants received a single booster dose of Tdap vaccine on Day 0.
121049|NCT01689207|B12|Baseline|Total|Total of all reporting groups
121050|NCT01689207|B11|Baseline|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
121051|NCT01689207|B10|Baseline|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
121052|NCT01689207|B9|Baseline|Part C: Placebo|Placebo
121053|NCT01689207|B8|Baseline|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
121054|NCT01689207|B7|Baseline|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
121055|NCT01689207|B6|Baseline|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
121056|NCT01689207|B5|Baseline|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
121057|NCT01689207|B4|Baseline|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
121058|NCT01689207|B3|Baseline|Part B: Placebo|Placebo
121059|NCT01689207|B2|Baseline|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
121060|NCT01689207|B1|Baseline|Part A: Placebo|Placebo
121061|NCT01689207|P11|Participant Flow|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
121062|NCT01689207|P10|Participant Flow|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
121063|NCT01689207|P9|Participant Flow|Part C: Placebo|Placebo
121064|NCT01689207|P8|Participant Flow|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
136547|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
121072|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
121073|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
121074|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
121075|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
121076|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
121077|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
121078|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
121079|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
121080|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
121081|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
121082|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
121083|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
121084|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
121085|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
121086|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
121087|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
121088|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
121089|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
121090|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
121091|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
121092|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
121093|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
121094|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
121095|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
121096|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
121097|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
121098|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
121099|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
121100|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
121101|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
121102|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
121103|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
121104|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
121105|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
121108|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
121109|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
121110|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
121111|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
121112|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
121113|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
121114|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
121115|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
121116|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
121117|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
121118|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
121119|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
121120|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
121121|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
121122|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
121123|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
121124|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
121125|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
121126|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
121127|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
121128|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
121129|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
121130|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
121131|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
121132|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
121133|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
121134|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
121135|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
121136|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
121137|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
121138|NCT01689207|O14|Outcome|Part A: ATM 2000mg + AVI 600mg|Crossover period ATM 2000mg + AVI 600mg
121139|NCT01689207|O13|Outcome|Part A: Avibactam (AVI) 600mg|Crossover period AVI 600mg
121140|NCT01689207|O12|Outcome|Part A: Aztreonam (ATM) 2000mg|Crossover period ATm 2000mg
121141|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
121142|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
121143|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
121144|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
121150|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
121151|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
121152|NCT01689207|E14|Reported Event|Part A: ATM 2000mg + AVI 600mg|Crossover period ATM 2000mg + AVI 600mg
121153|NCT01689207|E13|Reported Event|Part A: Avibactam (AVI) 600mg|Crossover period AVI 600mg
121154|NCT01689207|E12|Reported Event|Part A: Aztreonam (ATM) 2000mg|Crossover period ATM 2000mg
121155|NCT01689207|E11|Reported Event|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
121156|NCT01689207|E10|Reported Event|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
121157|NCT01689207|E9|Reported Event|Part C: Placebo|Placebo
121158|NCT01689207|E8|Reported Event|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
121159|NCT01689207|E7|Reported Event|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
121160|NCT01689207|E6|Reported Event|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
121161|NCT01689207|E5|Reported Event|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
121162|NCT01689207|E4|Reported Event|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
121163|NCT01689207|E3|Reported Event|Part B: Placebo|Placebo
121164|NCT01689207|E2|Reported Event|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
121165|NCT01689207|E1|Reported Event|Part A: Placebo|Placebo
121166|NCT01689155|B1|Baseline|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
121167|NCT01689155|P1|Participant Flow|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
121168|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
121169|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
122389|NCT01682863|O3|Outcome|QAB149 75 ug od|
121170|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
121171|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
121172|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
121173|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
121174|NCT01689155|E1|Reported Event|Menactra Vaccine Recipients|Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
121175|NCT01688921|B3|Baseline|Total|Total of all reporting groups
121176|NCT01688921|B2|Baseline|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121177|NCT01688921|B1|Baseline|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
STRATIS needle-free injection device"
121178|NCT01688921|P2|Participant Flow|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121179|NCT01688921|P1|Participant Flow|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
STRATIS needle-free injection device"
121180|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
PJ STRATIS needle-free injection device"
121181|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121182|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
PJ STRATIS needle-free injection device"
121183|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121184|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
PJ STRATIS needle-free injection device"
136548|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
121185|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121186|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
PJ STRATIS needle-free injection device"
121187|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121188|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
PJ STRATIS needle-free injection device"
121189|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121190|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
PJ STRATIS needle-free injection device"
121191|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121192|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
PJ STRATIS needle-free injection device"
121193|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121194|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
PJ STRATIS needle-free injection device"
121195|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121196|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
PJ STRATIS needle-free injection device"
121197|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121198|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
PJ STRATIS needle-free injection device"
121199|NCT01688921|E2|Reported Event|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-Syringe"
121200|NCT01688921|E1|Reported Event|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
STRATIS needle-free injection device"
121201|NCT01688882|B3|Baseline|Total|Total of all reporting groups
121202|NCT01688882|B2|Baseline|Placebo|Placebo to Match Q2W s.c.
121203|NCT01688882|B1|Baseline|QGE031|QGE031 240 mg Q2W s.c.
121204|NCT01688882|P2|Participant Flow|Placebo|Placebo to Match Q2W s.c.
121205|NCT01688882|P1|Participant Flow|QGE031|QGE031 240 mg Q2W s.c.
121206|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
121207|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
121208|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
121209|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
121210|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
121211|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
121212|NCT01688882|E6|Reported Event|Follow-up Period: Open Label QGE031|Follow-up Period after completion of Part 1 Open Label QGE031 Q2W s.c.
121213|NCT01688882|E5|Reported Event|Follow-up Period: Placebo|Follow-up Period after completion of Part 1 Placebo to Match Q2W s.c.
121214|NCT01688882|E4|Reported Event|Follow-up Period: QGE031|Follow-up Period after completion of Part 1 QGE031 240 mg Q2W s.c.
121215|NCT01688882|E3|Reported Event|Open Label QGE031|Open Label QGE031 Q2W s.c.
121216|NCT01688882|E2|Reported Event|Placebo|Placebo to Match Q2W s.c.
121217|NCT01688882|E1|Reported Event|QGE031|QGE031 240 mg Q2W s.c
121218|NCT01688830|B22|Baseline|Total|Total of all reporting groups
121219|NCT01688830|B21|Baseline|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121248|NCT01688830|P13|Participant Flow|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study"
121220|NCT01688830|B20|Baseline|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121221|NCT01688830|B19|Baseline|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121222|NCT01688830|B18|Baseline|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121223|NCT01688830|B17|Baseline|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121224|NCT01688830|B16|Baseline|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121225|NCT01688830|B15|Baseline|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121226|NCT01688830|B14|Baseline|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121227|NCT01688830|B13|Baseline|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study"
121228|NCT01688830|B12|Baseline|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo
This is administered during Part 1 of the study"
121229|NCT01688830|B11|Baseline|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study"
121230|NCT01688830|B10|Baseline|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study"
121231|NCT01688830|B9|Baseline|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121232|NCT01688830|B8|Baseline|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study"
121479|NCT01687790|O1|Outcome|Molecular Breast Imaging|Participants received molecular breast imaging before biopsy
121233|NCT01688830|B7|Baseline|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121234|NCT01688830|B6|Baseline|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study"
121235|NCT01688830|B5|Baseline|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study"
121236|NCT01688830|B4|Baseline|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study"
121237|NCT01688830|B3|Baseline|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study"
121238|NCT01688830|B2|Baseline|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study"
121239|NCT01688830|B1|Baseline|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo
This is administered during Part 1 of the study"
121240|NCT01688830|P21|Participant Flow|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121241|NCT01688830|P20|Participant Flow|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121242|NCT01688830|P19|Participant Flow|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121243|NCT01688830|P18|Participant Flow|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121244|NCT01688830|P17|Participant Flow|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121245|NCT01688830|P16|Participant Flow|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121246|NCT01688830|P15|Participant Flow|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121247|NCT01688830|P14|Participant Flow|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121249|NCT01688830|P12|Participant Flow|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo
This is administered during Part 1 of the study"
121250|NCT01688830|P11|Participant Flow|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study"
121251|NCT01688830|P10|Participant Flow|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study"
121252|NCT01688830|P9|Participant Flow|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121253|NCT01688830|P8|Participant Flow|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study"
121254|NCT01688830|P7|Participant Flow|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121255|NCT01688830|P6|Participant Flow|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study"
121256|NCT01688830|P5|Participant Flow|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study"
121257|NCT01688830|P4|Participant Flow|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study"
121258|NCT01688830|P3|Participant Flow|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study"
121259|NCT01688830|P2|Participant Flow|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study"
121260|NCT01688830|P1|Participant Flow|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo
This is administered during Part 1 of the study"
121261|NCT01688830|O2|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121262|NCT01688830|O1|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121314|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121263|NCT01688830|O4|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121264|NCT01688830|O3|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121265|NCT01688830|O2|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121266|NCT01688830|O1|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121267|NCT01688830|O8|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121268|NCT01688830|O7|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121269|NCT01688830|O6|Outcome|DE (Dose Groups 17: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose group 17
121270|NCT01688830|O5|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121271|NCT01688830|O4|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121272|NCT01688830|O3|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121273|NCT01688830|O2|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121274|NCT01688830|O1|Outcome|DE (Dose Groups 14−16: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose groups 14-16
121275|NCT01688830|O6|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121604|NCT01687218|B7|Baseline|Total|Total of all reporting groups
121276|NCT01688830|O5|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121277|NCT01688830|O4|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121278|NCT01688830|O3|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121279|NCT01688830|O2|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121280|NCT01688830|O1|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121281|NCT01688830|O8|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121282|NCT01688830|O7|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121283|NCT01688830|O6|Outcome|DE (Dose Groups 17: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose group 17
121284|NCT01688830|O5|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121285|NCT01688830|O4|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121286|NCT01688830|O3|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121287|NCT01688830|O2|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121288|NCT01688830|O1|Outcome|DE (Dose Groups 14−16: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose groups 14-16
121289|NCT01688830|O21|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121290|NCT01688830|O20|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121291|NCT01688830|O19|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121292|NCT01688830|O18|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121293|NCT01688830|O17|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121294|NCT01688830|O16|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121295|NCT01688830|O15|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121296|NCT01688830|O14|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121297|NCT01688830|O13|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study"
121298|NCT01688830|O12|Outcome|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo
This is administered during Part 1 of the study"
121299|NCT01688830|O11|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study"
121300|NCT01688830|O10|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study"
121620|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
121301|NCT01688830|O9|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121302|NCT01688830|O8|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study"
121303|NCT01688830|O7|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121304|NCT01688830|O6|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study"
121305|NCT01688830|O5|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study"
121306|NCT01688830|O4|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study"
121307|NCT01688830|O3|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study"
121308|NCT01688830|O2|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study"
121309|NCT01688830|O1|Outcome|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo
This is administered during Part 1 of the study"
121310|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121311|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121312|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121313|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121475|NCT01688050|E1|Reported Event|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
121315|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121316|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study"
121317|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study"
121318|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study"
121319|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121320|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study"
121321|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121322|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study"
121323|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study"
121324|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study"
121325|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study"
121326|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study"
121327|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121328|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121329|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121330|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121331|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121621|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
121332|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121333|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study"
121334|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study"
121335|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study"
121336|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121337|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study"
121338|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121339|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study"
121340|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study"
121341|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study"
121342|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study"
121343|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study"
121344|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121345|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121346|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121347|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121348|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121349|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121350|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study"
121351|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study"
121352|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study"
121353|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121354|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study"
121355|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121356|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study"
121357|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study"
121358|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study"
121359|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study"
121360|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study"
121361|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121362|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121363|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121364|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121365|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121366|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121367|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study"
121368|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study"
121369|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study"
121370|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study"
121371|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study"
121372|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study"
121373|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study"
121374|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study"
121375|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study"
121376|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study"
121377|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study"
121378|NCT01688830|E25|Reported Event|DE+ 5 g + 2.5 g Idarucizumab|"Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121476|NCT01687790|B1|Baseline|Molecular Breast Imaging|molecular breast imaging (Discovery)
121477|NCT01687790|P1|Participant Flow|Molecular Breast Imaging|molecular breast imaging (Discovery)
121379|NCT01688830|E24|Reported Event|DE+ 5 g|"One single intravenous short infusion (5 min) of 5 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121380|NCT01688830|E23|Reported Event|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121381|NCT01688830|E22|Reported Event|DE+ Placebo|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121382|NCT01688830|E21|Reported Event|DE (Dose Groups 17)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose group 17
121383|NCT01688830|E20|Reported Event|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121384|NCT01688830|E19|Reported Event|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121385|NCT01688830|E18|Reported Event|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1g of Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121386|NCT01688830|E17|Reported Event|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily"
121387|NCT01688830|E16|Reported Event|DE (Dose Groups 14−16)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose groups 14-16
121388|NCT01688830|E15|Reported Event|4 g Idarucizumab 5min|One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
121389|NCT01688830|E14|Reported Event|2 g Idarucizumab 5min|Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
121390|NCT01688830|E13|Reported Event|1 g Idarucizumab 5min|One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
121391|NCT01688830|E12|Reported Event|Placebo 5min|One single intravenous short infusion (5 min) of Idarucizumab Placebo
121392|NCT01688830|E11|Reported Event|8 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
121393|NCT01688830|E10|Reported Event|6 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
121394|NCT01688830|E9|Reported Event|4 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
121395|NCT01688830|E8|Reported Event|3 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
121396|NCT01688830|E7|Reported Event|2 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
121397|NCT01688830|E6|Reported Event|1.2 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
121398|NCT01688830|E5|Reported Event|600 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
121399|NCT01688830|E4|Reported Event|200 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
121400|NCT01688830|E3|Reported Event|60 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
121401|NCT01688830|E2|Reported Event|20 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
121402|NCT01688830|E1|Reported Event|Placebo 1 h|One single intravenous long infusion (1 h) of Idarucizumab Placebo
121403|NCT01688726|B3|Baseline|Total|Total of all reporting groups
121404|NCT01688726|B2|Baseline|Minims Saline|One drop 4 times a day for a continuous period of 1 month
121405|NCT01688726|B1|Baseline|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
121406|NCT01688726|P2|Participant Flow|Minims Saline|One drop 4 times a day for a continuous period of 1 month
121407|NCT01688726|P1|Participant Flow|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
121408|NCT01688726|O4|Outcome|Minims Saline/Left Eye|One drop 4 times a day for 1 month
121409|NCT01688726|O3|Outcome|Minims Saline/Right Eye|One drop 4 times a day for 1 month
121410|NCT01688726|O2|Outcome|SYSTANE BALANCE/Left Eye|One drop 4 times a day for 1 month
121411|NCT01688726|O1|Outcome|SYSTANE BALANCE/Right Eye|One drop 4 times a day for 1 month
121412|NCT01688726|O2|Outcome|Minims Saline|One drop 4 times a day for a continuous period of 1 month
121413|NCT01688726|O1|Outcome|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
121414|NCT01688726|O2|Outcome|Minims Saline|One drop 4 times a day for a continuous period of 1 month
121415|NCT01688726|O1|Outcome|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
121416|NCT01688726|E2|Reported Event|Minims Saline|One drop 4 times a day for a continuous period of 1 month
121417|NCT01688726|E1|Reported Event|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
121418|NCT01688635|B1|Baseline|LY2963016 and US-approved Lantus|Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study; Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods.
121419|NCT01688635|P2|Participant Flow|Lantus/LY/Lantus/LY|"A single 0.5-U/kg dose of US-approved Lantus administered subcutaneously during Periods 1 and 3.
A single 0.5-U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4.
There was at least a 7-day washout between treatment periods."
121420|NCT01688635|P1|Participant Flow|LY/Lantus/LY/Lantus|"A single 0.5-units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3.
A single 0.5-U/kg dose of US-approved Lantus (Lantus) administered subcutaneously during Periods 2 and 4.
There was at least a 7-day washout between treatment periods."
121421|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.
There was at least a 7-day washout between treatment periods."
121422|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.
There was at least a 7-day washout between treatment periods."
121423|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.
There was at least a 7-day washout between treatment periods."
121424|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.
There was at least a 7-day washout between treatment periods."
121425|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.
There was at least a 7-day washout between treatment periods."
121426|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.
There was at least a 7-day washout between treatment periods."
121427|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.
There was at least a 7-day washout between treatment periods."
121428|NCT01688635|O1|Outcome|LY2963016|Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods.
121429|NCT01688635|E2|Reported Event|US-approved Lantus|"Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously twice during the study.
There was at least a 7-day washout between the treatment periods."
121430|NCT01688635|E1|Reported Event|LY2963016|"Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.
There was at least a 7-day washout between the treatment periods."
121431|NCT01688336|B1|Baseline|FOLFIRINOX|"FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
Oxaliplatin (85 mg/m2)
Leucovorin (400mg/ m2)
Irinotecan (180 mg/m2)
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
121432|NCT01688336|P1|Participant Flow|FOLFIRINOX|"FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
Oxaliplatin (85 mg/m2)
Leucovorin (400mg/ m2)
Irinotecan (180 mg/m2)
Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
121433|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
Oxaliplatin (85 mg/m2)
Leucovorin (400mg/ m2)
Irinotecan (180 mg/m2)
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
121434|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
Oxaliplatin (85 mg/m2)
Leucovorin (400mg/ m2)
Irinotecan (180 mg/m2)
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
121435|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
Oxaliplatin (85 mg/m2)
Leucovorin (400mg/ m2)
Irinotecan (180 mg/m2)
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
121622|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
121436|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
Oxaliplatin (85 mg/m2)
Leucovorin (400mg/ m2)
Irinotecan (180 mg/m2)
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
121437|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
Oxaliplatin (85 mg/m2)
Leucovorin (400mg/ m2)
Irinotecan (180 mg/m2)
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
121438|NCT01688336|O1|Outcome|FOLFIRINOX|"FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
Oxaliplatin (85 mg/m2)
Leucovorin (400mg/ m2)
Irinotecan (180 mg/m2)
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
121439|NCT01688336|E1|Reported Event|FOLFIRINOX|"FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
Oxaliplatin (85 mg/m2)
Leucovorin (400mg/ m2)
Irinotecan (180 mg/m2)
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
121440|NCT01688310|B3|Baseline|Total|Total of all reporting groups
121441|NCT01688310|B2|Baseline|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
121442|NCT01688310|B1|Baseline|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
121443|NCT01688310|P2|Participant Flow|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
121444|NCT01688310|P1|Participant Flow|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
121445|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
121446|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
121447|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
121478|NCT01687790|O1|Outcome|Molecular Breast Imaging|molecular breast imaging (Discovery)
121448|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
121449|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
121450|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
121451|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
121452|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
121453|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
121454|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
121455|NCT01688310|O2|Outcome|Junior Physicians|Physicians who had very limited prior experience performing open surgical circumcisions.
121456|NCT01688310|O1|Outcome|Senior Physicians|Physicians who had extensive prior experience performing open surgical circumcisions.
121457|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
121458|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
121459|NCT01688310|E2|Reported Event|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
121460|NCT01688310|E1|Reported Event|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
121461|NCT01688102|B3|Baseline|Total|Total of all reporting groups
121462|NCT01688102|B2|Baseline|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
121623|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
121463|NCT01688102|B1|Baseline|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
121464|NCT01688102|P2|Participant Flow|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
121465|NCT01688102|P1|Participant Flow|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
121466|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
121467|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
121468|NCT01688102|E2|Reported Event|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
121469|NCT01688102|E1|Reported Event|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
121470|NCT01688050|B1|Baseline|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
121471|NCT01688050|P1|Participant Flow|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
121472|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
121473|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
121474|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
121480|NCT01687790|E1|Reported Event|Molecular Breast Imaging|molecular breast imaging (Discovery)
121482|NCT01687478|B2|Baseline|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121483|NCT01687478|B1|Baseline|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121484|NCT01687478|P2|Participant Flow|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121485|NCT01687478|P1|Participant Flow|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121486|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121487|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121488|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121489|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121490|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121491|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121492|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121493|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121494|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121495|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121624|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
121496|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121497|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121498|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121499|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121500|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121501|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121502|NCT01687478|O2|Outcome|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121503|NCT01687478|O1|Outcome|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121504|NCT01687478|E2|Reported Event|Placebo + Fluoxetine|"Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121505|NCT01687478|E1|Reported Event|Olanzapine + Fluoxetine|"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."
121506|NCT01687283|B3|Baseline|Total|Total of all reporting groups
121507|NCT01687283|B2|Baseline|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121508|NCT01687283|B1|Baseline|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121509|NCT01687283|P2|Participant Flow|BUD 2 mg BID|Participants received Budesonide (BUD) oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121578|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
121510|NCT01687283|P1|Participant Flow|FP 1 mg BID|Participants received Fluticasone propionate (FP) oral inhalation (inhal) solution (sol'n) 1 milligram (mg) twice daily (BID) via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121511|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121512|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121513|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121514|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121515|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121516|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121517|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121518|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121519|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121520|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121521|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121522|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121523|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121524|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121525|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121526|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121527|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121528|NCT01687283|O2|Outcome|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121529|NCT01687283|O1|Outcome|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121530|NCT01687283|E2|Reported Event|BUD 2 mg BID|Participants received BUD oral suspension for inhalation 2 mg BID via nebulizer for a treatment period of 12 weeks participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121531|NCT01687283|E1|Reported Event|FP 1 mg BID|Participants received FP oral inhalation solution 1 mg BID via nebulizer for a treatment period of 12 weeks. participants were allowed to use salbutamol aerosol inhaler for rescue of symptoms, and were followed-up for 2 weeks.
121532|NCT01687270|B1|Baseline|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
121533|NCT01687270|P1|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet once daily plus ribavirin (RBV) tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
121534|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
121535|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
121536|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
121537|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
121538|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
121539|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
121540|NCT01687270|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
121541|NCT01687257|B3|Baseline|Total|Total of all reporting groups
121542|NCT01687257|B2|Baseline|SOF+RBV (Group 2; Received Treatment)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
121543|NCT01687257|B1|Baseline|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
121544|NCT01687257|P3|Participant Flow|Observation/SOF+RBV (Group 2; Received Treatment)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
121545|NCT01687257|P2|Participant Flow|Observation/SOF+RBV (Group 2; Not Treated)|This reporting group only includes participants who were randomized to the Observation/SOF+RBV group who discontinued study prior to receiving study drug.
121546|NCT01687257|P1|Participant Flow|SOF+RBV (Group 1)|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
121547|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks in both Groups 1 and 2
121548|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
121549|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
121550|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
121551|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks in both Groups 1 and 2
121552|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
121553|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
121554|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
121555|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 48 weeks in both Groups 1 and 2
121556|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 48 weeks
121557|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
121625|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
121558|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
121559|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
121560|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
121561|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
121562|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
121563|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
121564|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
121565|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
121566|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
121567|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
121568|NCT01687257|E3|Reported Event|SOF+RBV Treatment Only (Group 2)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
121569|NCT01687257|E2|Reported Event|Observation Period Only (Group 2)|This reporting group includes participants who were randomized to the Observation/SOF+RBV group and received up to 24 weeks of observation.
121570|NCT01687257|E1|Reported Event|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
121571|NCT01687244|B3|Baseline|Total|Total of all reporting groups
121572|NCT01687244|B2|Baseline|rAd-IFN Dose 3x10^11 Vps/ml|Patients were randomly assigned to the 3x10^11vps/ml of rAd-IFN/Syn3 arm.
121573|NCT01687244|B1|Baseline|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11vps/ml of rAd-IFN/Syn3 arm.
121574|NCT01687244|P2|Participant Flow|rAd-IFN Dose 3x10^11 Vps/ml|"Patients were randomized to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations."
121575|NCT01687244|P1|Participant Flow|rAd-IFN Dose 1x10^11vps/ml|"Patients were randomized to the 1x10^11vps/ml rAd-IFN/Syn3 arm.
A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations."
121576|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/mL|Patients were randomly assigned to the 3x10^11 vps/ml rAd-IFN/Syn3 arm.
121577|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
122390|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
121579|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
121580|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
121581|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
121582|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
121583|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
121584|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
121585|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
121586|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
121587|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
121588|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Subjects were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
121589|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
121590|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
121591|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
121592|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
121593|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
121594|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
121595|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
121596|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
121597|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
121598|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11 Vps/ml|Patients were randomly assigned to the 3x10^11 vps/ml rAd-IFN/Syn3 arm.
121599|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11vps/ml rAd-IFN/Syn3 arm.
121600|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
121601|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Subjects were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
121602|NCT01687244|E2|Reported Event|rAd-IFN Dose 3x10^11vps/ml|Patients were randomized the 3x10^11 vps/ml INSTILADRIN arm.
121603|NCT01687244|E1|Reported Event|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomized to the 1x10^11 vps/ml INSTILADRIN arm.
121605|NCT01687218|B6|Baseline|Group 6|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121606|NCT01687218|B5|Baseline|Group 5|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121607|NCT01687218|B4|Baseline|Group 4|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121608|NCT01687218|B3|Baseline|Group 3|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121609|NCT01687218|B2|Baseline|Group 2|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121610|NCT01687218|B1|Baseline|Group 1|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121649|NCT01687088|O1|Outcome|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
121650|NCT01687088|E2|Reported Event|Controls|No significant headache or disability as defined by migraine disability scale.
121651|NCT01687088|E1|Reported Event|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
121611|NCT01687218|P6|Participant Flow|Group 6|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121612|NCT01687218|P5|Participant Flow|Group 5|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121613|NCT01687218|P4|Participant Flow|Group 4|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121614|NCT01687218|P3|Participant Flow|Group 3|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121615|NCT01687218|P2|Participant Flow|Group 2|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121616|NCT01687218|P1|Participant Flow|Group 1|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
121617|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
121618|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
121619|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
121626|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
121627|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
121628|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
121629|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
121630|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
121631|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
121632|NCT01687218|E3|Reported Event|Product 3|Rectal (RAI-associated TFV RG 1% gel)
121633|NCT01687218|E2|Reported Event|Product 2|Rectal (Daily TFV RG 1% gel)
121634|NCT01687218|E1|Reported Event|Product 1|Oral (Daily FTC/TDF)
121635|NCT01687114|B1|Baseline|Cranberry Juice|"27% cranberry juice
cranberry juice: 27% cranberry juice"
121636|NCT01687114|P1|Participant Flow|Cranberry Juice|"27% cranberry juice
cranberry juice: 27% cranberry juice"
121637|NCT01687114|O1|Outcome|Cranberry Juice|"27% cranberry juice
cranberry juice: 27% cranberry juice"
121638|NCT01687114|E1|Reported Event|Cranberry Juice|"27% cranberry juice
cranberry juice: 27% cranberry juice"
121639|NCT01687101|B1|Baseline|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
121640|NCT01687101|P1|Participant Flow|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
121641|NCT01687101|O1|Outcome|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
121642|NCT01687101|E1|Reported Event|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
121643|NCT01687088|B3|Baseline|Total|Total of all reporting groups
121644|NCT01687088|B2|Baseline|Controls|No significant headache or disability as defined by migraine disability scale.
121645|NCT01687088|B1|Baseline|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
121646|NCT01687088|P2|Participant Flow|Controls|No significant headache or disability as defined by migraine disability scale.
121647|NCT01687088|P1|Participant Flow|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
121648|NCT01687088|O2|Outcome|Controls|No significant headache or disability as defined by migraine disability scale.
121652|NCT01687036|B1|Baseline|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
121653|NCT01687036|P1|Participant Flow|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System (single treatment during visit 3)."
121654|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
121655|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
121656|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
121657|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
121658|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
121659|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
121660|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
121661|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
121662|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
121663|NCT01687036|E1|Reported Event|Cryoablation|"Cryoablation
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
121664|NCT01686932|B3|Baseline|Total|Total of all reporting groups
121665|NCT01686932|B2|Baseline|Sitagliptin Followed by Vildagliptin|Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks
121666|NCT01686932|B1|Baseline|Vildagliptin Followed by Sitagliptin|Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks
121667|NCT01686932|P2|Participant Flow|Sitagliptin Followed by Vildagliptin|Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks
121668|NCT01686932|P1|Participant Flow|Vildagliptin Followed by Sitagliptin|Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks
121669|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121670|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121671|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121672|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121673|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121674|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121675|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121676|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121677|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121678|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121679|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121680|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121681|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121682|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121683|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121684|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121685|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121686|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121687|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121688|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121689|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121690|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121691|NCT01686932|E2|Reported Event|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
121692|NCT01686932|E1|Reported Event|Vildagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
121693|NCT01686828|B5|Baseline|Total|Total of all reporting groups
121694|NCT01686828|B4|Baseline|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
121695|NCT01686828|B3|Baseline|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121750|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121751|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121696|NCT01686828|B2|Baseline|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121697|NCT01686828|B1|Baseline|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121698|NCT01686828|P4|Participant Flow|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
121699|NCT01686828|P3|Participant Flow|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121700|NCT01686828|P2|Participant Flow|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121701|NCT01686828|P1|Participant Flow|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121702|NCT01686828|O4|Outcome|Acyline + Testosterone Gel (5g/d) + Letrozole|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily letrozole (pills). This group was intended to have normal levels of serum testosterone with selective estrogen deficiency.
121703|NCT01686828|O3|Outcome|Acyline + Testosterone Gel (5g/d) + Placebo Pills|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily placebo pills. This group was intended to have normal, physiologic levels of serum testosterone and estradiol.
121704|NCT01686828|O2|Outcome|Acyline + Testosterone Gel (1.25g/d) + Placebo Pills|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily placebo pills. This group was intended to have low-normal levels of serum testosterone and estradiol.
121705|NCT01686828|O1|Outcome|Acyline + Placebo Gel + Placebo Pills|Acyline (300 mg/kg, subcutaneous injection at weeks 0, 2) + placebo gel + oral placebo pills daily. This treatment regimen resulted in medical castration.
121730|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121731|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121706|NCT01686828|O4|Outcome|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
121707|NCT01686828|O3|Outcome|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121708|NCT01686828|O2|Outcome|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121709|NCT01686828|O1|Outcome|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121710|NCT01686828|O4|Outcome|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
121711|NCT01686828|O3|Outcome|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121712|NCT01686828|O2|Outcome|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121713|NCT01686828|O1|Outcome|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121714|NCT01686828|E4|Reported Event|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
121715|NCT01686828|E3|Reported Event|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121716|NCT01686828|E2|Reported Event|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121717|NCT01686828|E1|Reported Event|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks
Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel
Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
121718|NCT01686646|B5|Baseline|Total|Total of all reporting groups
121719|NCT01686646|B4|Baseline|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121720|NCT01686646|B3|Baseline|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121721|NCT01686646|B2|Baseline|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121722|NCT01686646|B1|Baseline|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121723|NCT01686646|P4|Participant Flow|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121724|NCT01686646|P3|Participant Flow|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121725|NCT01686646|P2|Participant Flow|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121726|NCT01686646|P1|Participant Flow|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 milligrams [mg] ) and caffeine (65 mg) tablets were dissolved in 200 milliliter (mL) of water and administered orally.
121727|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121728|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121729|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121732|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121733|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121734|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121735|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121736|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121737|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121738|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121739|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121740|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121741|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121742|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121743|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121744|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121745|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121746|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121747|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121748|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121749|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
122391|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
121752|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121753|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121754|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121755|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121756|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121757|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121758|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121759|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121760|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121761|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121762|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121763|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121764|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121765|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121766|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121767|NCT01686646|E4|Reported Event|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
121768|NCT01686646|E3|Reported Event|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
121769|NCT01686646|E2|Reported Event|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
121770|NCT01686646|E1|Reported Event|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
121771|NCT01686633|B4|Baseline|Total|Total of all reporting groups
121772|NCT01686633|B3|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121773|NCT01686633|B2|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121800|NCT01686568|B2|Baseline|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121774|NCT01686633|B1|Baseline|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121775|NCT01686633|P3|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121776|NCT01686633|P2|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121777|NCT01686633|P1|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder once daily (OD) in the evening from a dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121778|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121779|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121780|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121781|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121782|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121783|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121784|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121823|NCT01686568|E1|Reported Event|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
121824|NCT01686503|B5|Baseline|Total|Total of all reporting groups
121785|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121786|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121787|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121788|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121789|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121790|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121791|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121792|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121793|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121794|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121795|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121796|NCT01686633|E3|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121797|NCT01686633|E2|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121798|NCT01686633|E1|Reported Event|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
121799|NCT01686568|B3|Baseline|Total|Total of all reporting groups
121801|NCT01686568|B1|Baseline|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
121802|NCT01686568|P2|Participant Flow|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121803|NCT01686568|P1|Participant Flow|Omega-3|Patients in this group will receive oral supplementation with EPA + Docosahexaenoic acid (DHA) (3.9grams/day) for 6 months.
121804|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121805|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
121806|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121807|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
121808|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121809|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
121810|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121811|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
121812|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121813|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
121814|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121815|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
121816|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121817|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
121818|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121819|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
121820|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121821|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
121822|NCT01686568|E2|Reported Event|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
121825|NCT01686503|B4|Baseline|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121826|NCT01686503|B3|Baseline|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121827|NCT01686503|B2|Baseline|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121828|NCT01686503|B1|Baseline|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121829|NCT01686503|P4|Participant Flow|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121830|NCT01686503|P3|Participant Flow|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121831|NCT01686503|P2|Participant Flow|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121832|NCT01686503|P1|Participant Flow|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121833|NCT01686503|O4|Outcome|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121857|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
136549|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
121834|NCT01686503|O3|Outcome|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121835|NCT01686503|O2|Outcome|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121836|NCT01686503|O1|Outcome|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121837|NCT01686503|O4|Outcome|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121838|NCT01686503|O3|Outcome|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121839|NCT01686503|O2|Outcome|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121840|NCT01686503|O1|Outcome|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121841|NCT01686503|E4|Reported Event|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
122392|NCT01682863|E3|Reported Event|QAB75|QVA149 27.5/25 μg capsules
121842|NCT01686503|E3|Reported Event|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121843|NCT01686503|E2|Reported Event|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121844|NCT01686503|E1|Reported Event|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
121845|NCT01686451|B3|Baseline|Total|Total of all reporting groups
121846|NCT01686451|B2|Baseline|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121847|NCT01686451|B1|Baseline|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121848|NCT01686451|P2|Participant Flow|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121849|NCT01686451|P1|Participant Flow|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121850|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121851|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121852|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121853|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121854|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121855|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121856|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121919|NCT01685801|O2|Outcome|Cycle 1: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
121858|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121859|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121860|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121861|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121862|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121863|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121864|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121865|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121866|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121867|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121868|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121869|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121870|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121871|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121872|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121873|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
122393|NCT01682863|E2|Reported Event|QVA149 27.5/25 ug Bid|
121874|NCT01686451|E2|Reported Event|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
121875|NCT01686451|E1|Reported Event|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
121876|NCT01685996|B3|Baseline|Total|Total of all reporting groups
121877|NCT01685996|B2|Baseline|Placebo|Participants receive placebo + varenicline for smoking cessation
121878|NCT01685996|B1|Baseline|Zonisamide|Participants receive zonisamide + varenicline for smoking cessation
121879|NCT01685996|P2|Participant Flow|Placebo|"Participants will receive placebo capsules to take once a day
placebo"
121880|NCT01685996|P1|Participant Flow|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.
zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
121881|NCT01685996|O2|Outcome|Placebo|"Participants will receive placebo capsules to take once a day
placebo"
121882|NCT01685996|O1|Outcome|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.
zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
121883|NCT01685996|O2|Outcome|Placebo|"Participants will receive placebo capsules to take once a day
placebo"
121884|NCT01685996|O1|Outcome|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.
zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
121885|NCT01685996|E2|Reported Event|Placebo|"Participants will receive placebo capsules to take once a day
placebo"
121886|NCT01685996|E1|Reported Event|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.
zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
121887|NCT01685983|B1|Baseline|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
121888|NCT01685983|P1|Participant Flow|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
121889|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
121920|NCT01685801|O1|Outcome|Cycle 1: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
121890|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
121891|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
121892|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
121893|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
121894|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
121895|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
121896|NCT01685983|E1|Reported Event|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
121897|NCT01685801|B5|Baseline|Total|Total of all reporting groups
121898|NCT01685801|B4|Baseline|PIPI|Detailed reporting group description is provided in Participant Flow module.
121899|NCT01685801|B3|Baseline|PIIP|Detailed reporting group description is provided in Participant Flow module.
121900|NCT01685801|B2|Baseline|IPPI|Detailed reporting group description is provided in Participant Flow module.
121901|NCT01685801|B1|Baseline|IPIP|Detailed reporting group description is provided in Participant Flow module.
121902|NCT01685801|P4|Participant Flow|Placebo, Ivacaftor, Placebo, Ivacaftor (PIPI)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
121951|NCT01685684|E1|Reported Event|Screening|Serious Adverse Event (SAE) collection started during screening.
122317|NCT01682876|P3|Participant Flow|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
121903|NCT01685801|P3|Participant Flow|Placebo, Ivacaftor, Ivacaftor, Placebo (PIIP)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
121904|NCT01685801|P2|Participant Flow|Ivacaftor, Placebo, Placebo, Ivacaftor (IPPI)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
121905|NCT01685801|P1|Participant Flow|Ivacaftor, Placebo, Ivacaftor, Placebo (IPIP)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
121906|NCT01685801|O3|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
121907|NCT01685801|O2|Outcome|Crossover Double-blind Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
121908|NCT01685801|O1|Outcome|Crossover Double-blind Period: Placebo|Placebo matched to ivacaftor tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
121909|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
121910|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
121911|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours in open-label period (8 weeks) after washout period 2.
121912|NCT01685801|O1|Outcome|Open-Label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
121913|NCT01685801|O4|Outcome|Cycle 2: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of cycle 2.
121914|NCT01685801|O3|Outcome|Cycle 2: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
121915|NCT01685801|O2|Outcome|Cycle 1: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of cycle 1.
121916|NCT01685801|O1|Outcome|Cycle 1: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
121917|NCT01685801|O4|Outcome|Cycle 2: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
121918|NCT01685801|O3|Outcome|Cycle 2: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
122795|NCT01682837|E4|Reported Event|Placebo Phase|Participants undergoing the Placebo phase of the study.
121921|NCT01685801|E3|Reported Event|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
121922|NCT01685801|E2|Reported Event|Crossover Double-blind Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
121923|NCT01685801|E1|Reported Event|Crossover Double-blind Period: Placebo|Placebo matched to ivacaftor tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
121924|NCT01685684|B3|Baseline|Total|Total of all reporting groups
121925|NCT01685684|B2|Baseline|Placebo (Double-blind Maintenance Phase)|
121926|NCT01685684|B1|Baseline|Oxycodone DETERx (Double-blind Maintenance Phase)|
121927|NCT01685684|P3|Participant Flow|Placebo (Double-blind Maintenance Phase)|Placebo: Placebo, divided into 2 doses, q12h
121928|NCT01685684|P2|Participant Flow|Oxycodone DETERx (Double-blind Maintenance Phase)|Oxycodone DETERx: 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
121929|NCT01685684|P1|Participant Flow|Oxycodone DETERx (Titration Phase)|Achieve a stable Oxycodone DETERx dose of 40-160 mg total daily dose.
121930|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
121931|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
121932|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
121933|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
121934|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
121935|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
121936|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
121937|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
121938|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
121939|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
121940|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
121941|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
121942|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
121943|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
121944|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
121945|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
121946|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
121947|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
121948|NCT01685684|E4|Reported Event|Placebo (Double-blind Maintenance Phase)|
121949|NCT01685684|E3|Reported Event|Oxycodone DETERx (Double-blind Maintenance Phase)|
121950|NCT01685684|E2|Reported Event|Oxycodone DETERx (Titration Phase)|
121952|NCT01685606|B1|Baseline|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
121953|NCT01685606|P1|Participant Flow|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
121954|NCT01685606|O1|Outcome|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
121955|NCT01685606|O1|Outcome|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
121956|NCT01685606|E1|Reported Event|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
121957|NCT01685567|B1|Baseline|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
121958|NCT01685567|P1|Participant Flow|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
121959|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
121960|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
121961|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
121962|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
121963|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
121964|NCT01685567|E1|Reported Event|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
121965|NCT01685437|B1|Baseline|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
121966|NCT01685437|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
124846|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
121967|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
121968|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
121969|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
121970|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
121971|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
121972|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
121973|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
121974|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
121975|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
121976|NCT01685437|E1|Reported Event|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
121977|NCT01685320|B3|Baseline|Total|Total of all reporting groups
121978|NCT01685320|B2|Baseline|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
121979|NCT01685320|B1|Baseline|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
121980|NCT01685320|P2|Participant Flow|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
121981|NCT01685320|P1|Participant Flow|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
122394|NCT01682863|E1|Reported Event|QVA149 27.5/12.5 ug Bid|
121982|NCT01685320|O2|Outcome|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
121983|NCT01685320|O1|Outcome|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
121984|NCT01685320|O2|Outcome|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
121985|NCT01685320|O1|Outcome|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
121986|NCT01685320|E2|Reported Event|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
121987|NCT01685320|E1|Reported Event|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
121988|NCT01685216|B1|Baseline|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
121989|NCT01685216|P1|Participant Flow|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
121990|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
121991|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
121992|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
121993|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
121994|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
121995|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
121996|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
121997|NCT01685216|E1|Reported Event|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
121998|NCT01685203|B8|Baseline|Total|Total of all reporting groups
122062|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
136550|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
121999|NCT01685203|B7|Baseline|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
122000|NCT01685203|B6|Baseline|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
122001|NCT01685203|B5|Baseline|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
122002|NCT01685203|B4|Baseline|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122003|NCT01685203|B3|Baseline|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
122004|NCT01685203|B2|Baseline|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
122005|NCT01685203|B1|Baseline|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122006|NCT01685203|P7|Participant Flow|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
122007|NCT01685203|P6|Participant Flow|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
122008|NCT01685203|P5|Participant Flow|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
122009|NCT01685203|P4|Participant Flow|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122010|NCT01685203|P3|Participant Flow|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
122011|NCT01685203|P2|Participant Flow|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
122012|NCT01685203|P1|Participant Flow|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122013|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
122014|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
122015|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
122016|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122017|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
122018|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
122019|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122020|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
122021|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
122022|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
122023|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122024|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
122025|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
122026|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122027|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
122028|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
122063|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122029|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
122030|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122031|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
122032|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
122033|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122034|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
122035|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
122036|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
122037|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122038|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
122039|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
122040|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122041|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
122042|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
122043|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
122318|NCT01682876|P2|Participant Flow|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122044|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122045|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
122046|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
122047|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122048|NCT01685203|E7|Reported Event|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/ RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
122049|NCT01685203|E6|Reported Event|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
122050|NCT01685203|E5|Reported Event|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/ RBV (pegIFN/RBV) treatment-experienced participants
122051|NCT01685203|E4|Reported Event|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122052|NCT01685203|E3|Reported Event|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
122053|NCT01685203|E2|Reported Event|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
122054|NCT01685203|E1|Reported Event|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
122055|NCT01685060|B1|Baseline|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122056|NCT01685060|P1|Participant Flow|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122057|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122058|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122059|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122060|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122061|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122064|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122065|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122066|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122067|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122068|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122069|NCT01685060|E1|Reported Event|LDK378 750 mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
122070|NCT01684930|B3|Baseline|Total|Total of all reporting groups
122071|NCT01684930|B2|Baseline|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
122072|NCT01684930|B1|Baseline|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
122073|NCT01684930|P2|Participant Flow|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
122074|NCT01684930|P1|Participant Flow|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
122075|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
122076|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
122077|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
122183|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).
Placebo"
122078|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
122079|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
122080|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
122081|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
122319|NCT01682876|P1|Participant Flow|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
122082|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
122083|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
122084|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
122085|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
122086|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
122087|NCT01684930|E2|Reported Event|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
122088|NCT01684930|E1|Reported Event|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
122089|NCT01684878|B5|Baseline|Total|Total of all reporting groups
122090|NCT01684878|B4|Baseline|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122091|NCT01684878|B3|Baseline|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122092|NCT01684878|B2|Baseline|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
122093|NCT01684878|B1|Baseline|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
122094|NCT01684878|P4|Participant Flow|Part 2: Placebo+Chemotherapy|Participants received pertuzumab-matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122095|NCT01684878|P3|Participant Flow|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122096|NCT01684878|P2|Participant Flow|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
122097|NCT01684878|P1|Participant Flow|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
122098|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122099|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122100|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122101|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122102|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122103|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122104|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122105|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122106|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
122107|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
122108|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122109|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122110|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
122111|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
122112|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122113|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122114|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
122115|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
122386|NCT01682863|O3|Outcome|QAB149 75 ug od|
122116|NCT01684878|E4|Reported Event|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122117|NCT01684878|E3|Reported Event|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
122118|NCT01684878|E2|Reported Event|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
122119|NCT01684878|E1|Reported Event|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
122120|NCT01684839|B1|Baseline|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
122121|NCT01684839|P1|Participant Flow|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
122122|NCT01684839|O1|Outcome|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
122123|NCT01684839|E1|Reported Event|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
122124|NCT01684826|B1|Baseline|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
122125|NCT01684826|P1|Participant Flow|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
122126|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
122127|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
122128|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
122129|NCT01684826|E1|Reported Event|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
122130|NCT01684748|B3|Baseline|Total|Total of all reporting groups
122131|NCT01684748|B2|Baseline|No Drug First, Then Olmesartan Medoxomil|During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.
122152|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122132|NCT01684748|B1|Baseline|Olmesartan Medoxomil First, Then No Drug|"During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.
Olmesartan medoxomil"
122133|NCT01684748|P2|Participant Flow|No Drug First, Then Olmesartan Medoxomil|During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.
122134|NCT01684748|P1|Participant Flow|Olmesartan Medoxomil First, Then No Drug|"During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.
Olmesartan medoxomil"
122135|NCT01684748|O2|Outcome|No Drug Intervention|The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
122136|NCT01684748|O1|Outcome|Olmesartan Medoxomil|"Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.
Olmesartan medoxomil"
122137|NCT01684748|E2|Reported Event|No Drug Intervention|The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
122138|NCT01684748|E1|Reported Event|Olmesartan Medoxomil|"Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.
Olmesartan medoxomil"
122139|NCT01684566|B3|Baseline|Total|Total of all reporting groups
122140|NCT01684566|B2|Baseline|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122141|NCT01684566|B1|Baseline|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122142|NCT01684566|P2|Participant Flow|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122143|NCT01684566|P1|Participant Flow|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122144|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122145|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122146|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122147|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122148|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122149|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122150|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122151|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122153|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122154|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122155|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122156|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122157|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122158|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122159|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122160|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122161|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122162|NCT01684566|E2|Reported Event|Standard-Of-Care|"Oral hygiene procedures
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122308|NCT01682954|O1|Outcome|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention
Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
122387|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
122163|NCT01684566|E1|Reported Event|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
122164|NCT01684436|B1|Baseline|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
122165|NCT01684436|P1|Participant Flow|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
122166|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
122167|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
122168|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
122169|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
122170|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
122171|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
122172|NCT01684436|E1|Reported Event|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
122173|NCT01684410|B4|Baseline|Total|Total of all reporting groups
122174|NCT01684410|B3|Baseline|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).
Placebo"
122175|NCT01684410|B2|Baseline|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122176|NCT01684410|B1|Baseline|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122177|NCT01684410|P3|Participant Flow|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).
Placebo"
122178|NCT01684410|P2|Participant Flow|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122179|NCT01684410|P1|Participant Flow|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122180|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).
Placebo"
122181|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122182|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122184|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122185|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122186|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).
Placebo"
122187|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122188|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122189|NCT01684410|E3|Reported Event|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).
Placebo"
122190|NCT01684410|E2|Reported Event|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122191|NCT01684410|E1|Reported Event|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
122192|NCT01684215|B5|Baseline|Total|Total of all reporting groups
122193|NCT01684215|B4|Baseline|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122194|NCT01684215|B3|Baseline|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122195|NCT01684215|B2|Baseline|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122196|NCT01684215|B1|Baseline|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122197|NCT01684215|P4|Participant Flow|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122198|NCT01684215|P3|Participant Flow|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122199|NCT01684215|P2|Participant Flow|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122200|NCT01684215|P1|Participant Flow|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122201|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122202|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122203|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122204|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122205|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122206|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
124847|NCT01674010|E3|Reported Event|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
122207|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122208|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122209|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122210|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122211|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122212|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122213|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122214|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122215|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122309|NCT01682954|E2|Reported Event|Usual Care|Usual care from primary care physician
122310|NCT01682954|E1|Reported Event|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention
Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
122216|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122217|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122218|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122219|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122220|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122221|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122222|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122223|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122224|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122343|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
136551|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
122225|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122226|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122227|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122228|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122229|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122230|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122231|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122232|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122233|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122311|NCT01682876|B5|Baseline|Total|Total of all reporting groups
122234|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122235|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122236|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122237|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122238|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122239|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122240|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122241|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122344|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
136552|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
122242|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122243|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122244|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122245|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122246|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122247|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122248|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122249|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122250|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122312|NCT01682876|B4|Baseline|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
122313|NCT01682876|B3|Baseline|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
122251|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122252|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122253|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122254|NCT01684215|O4|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122255|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122256|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122257|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122258|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122345|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
122259|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122260|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122261|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122262|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122263|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122264|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122265|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122266|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122267|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122268|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122314|NCT01682876|B2|Baseline|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122315|NCT01682876|B1|Baseline|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
122269|NCT01684215|E4|Reported Event|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122270|NCT01684215|E3|Reported Event|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122271|NCT01684215|E2|Reported Event|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122272|NCT01684215|E1|Reported Event|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
122273|NCT01684046|B1|Baseline|PureMoist / RevitaLens|Opti-Free® PureMoist® MPDS and RevitaLens MPDS used during Period 1 and Period 2 in randomized order in crossover assignment.
122274|NCT01684046|P2|Participant Flow|RevitaLens - PureMoist|RevitaLens MPDS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
122275|NCT01684046|P1|Participant Flow|PureMoist - RevitaLens|Opti-Free® PureMoist® MPDS, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
122276|NCT01684046|O2|Outcome|RevitaLens|RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
122277|NCT01684046|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
122278|NCT01684046|E2|Reported Event|RevitaLens|RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
122279|NCT01684046|E1|Reported Event|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
122280|NCT01684033|B1|Baseline|PureMoist / Biotrue|Opti-Free® PureMoist® MPDS and Biotrue™ MPS used during Period 1 and Period 2 in randomized order in crossover assignment.
124848|NCT01674010|E2|Reported Event|Phase 2 Placebo|Double Blind Randomization (Phase 2)
122281|NCT01684033|P2|Participant Flow|Biotrue - PureMoist|Biotrue™ MPS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
122282|NCT01684033|P1|Participant Flow|PureMoist - Biotrue|Opti-Free® PureMoist® MPDS, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
122283|NCT01684033|O2|Outcome|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
122284|NCT01684033|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
122285|NCT01684033|O2|Outcome|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
122286|NCT01684033|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
122287|NCT01684033|E2|Reported Event|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
122288|NCT01684033|E1|Reported Event|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
122289|NCT01684007|B3|Baseline|Total|Total of all reporting groups
122290|NCT01684007|B2|Baseline|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
122291|NCT01684007|B1|Baseline|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
122292|NCT01684007|P2|Participant Flow|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
122293|NCT01684007|P1|Participant Flow|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
122294|NCT01684007|O2|Outcome|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
122295|NCT01684007|O1|Outcome|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
122296|NCT01684007|O2|Outcome|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
122297|NCT01684007|O1|Outcome|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
122298|NCT01684007|E2|Reported Event|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
122299|NCT01684007|E1|Reported Event|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
122300|NCT01682954|B3|Baseline|Total|Total of all reporting groups
122301|NCT01682954|B2|Baseline|Usual Care|Usual care from primary care physician
122302|NCT01682954|B1|Baseline|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention
Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
122303|NCT01682954|P2|Participant Flow|Usual Care|Usual care from primary care physician
122304|NCT01682954|P1|Participant Flow|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention
Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
122305|NCT01682954|O2|Outcome|Usual Care|Usual care from primary care physician
122306|NCT01682954|O1|Outcome|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention
Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
122307|NCT01682954|O2|Outcome|Usual Care|Usual care from primary care physician
122316|NCT01682876|P4|Participant Flow|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
122320|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
122321|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
122322|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122323|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
122324|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
122325|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
122326|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122327|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
122328|NCT01682876|O2|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
122329|NCT01682876|O1|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
122330|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122331|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
122332|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
122333|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
122334|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122335|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
122336|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
122337|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
122338|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122339|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
122340|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
122341|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
122342|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122346|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122347|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
122348|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
122349|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
122350|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122351|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
122352|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
122353|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
122354|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122355|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
122356|NCT01682876|E5|Reported Event|Total|Total Population
122357|NCT01682876|E4|Reported Event|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
122358|NCT01682876|E3|Reported Event|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
122359|NCT01682876|E2|Reported Event|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
122360|NCT01682876|E1|Reported Event|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
122361|NCT01682863|B4|Baseline|Total|Total of all reporting groups
122362|NCT01682863|B3|Baseline|QAB149 75 ug od|
122363|NCT01682863|B2|Baseline|QVA149 27.5/25 ug Bid|
122364|NCT01682863|B1|Baseline|QVA149 27.5/12.5 ug Bid|
122365|NCT01682863|P3|Participant Flow|QAB149 75 ug od|
122366|NCT01682863|P2|Participant Flow|QVA149 27.5/25 ug Bid|
122367|NCT01682863|P1|Participant Flow|QVA149 27.5/12.5 ug Bid|
122368|NCT01682863|O3|Outcome|QAB149 75 ug od|
122369|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
122370|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
122371|NCT01682863|O3|Outcome|QAB149 75 ug od|
122372|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
122373|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
122374|NCT01682863|O3|Outcome|QAB149 75 ug od|
122375|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
122376|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
122377|NCT01682863|O3|Outcome|QAB149 75 ug od|
122378|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
122379|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
122380|NCT01682863|O3|Outcome|QAB149 75 ug od|
122381|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
122382|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
122383|NCT01682863|O3|Outcome|QAB149 75 ug od|
122384|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
122385|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
122395|NCT01683838|B3|Baseline|Total|Total of all reporting groups
122396|NCT01683838|B2|Baseline|Placebo|Placebo : Placebo
122397|NCT01683838|B1|Baseline|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122398|NCT01683838|P2|Participant Flow|Placebo|Placebo : Placebo
122399|NCT01683838|P1|Participant Flow|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122400|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
122401|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122402|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
122403|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122404|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
122405|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122406|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
122407|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122408|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
122409|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122410|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
122411|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122412|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
122413|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122414|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
122415|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122416|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
122417|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122418|NCT01683838|E2|Reported Event|Placebo|Placebo : Placebo
122419|NCT01683838|E1|Reported Event|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
122420|NCT01683812|B1|Baseline|Cranial Cup Arm|"Single arm
Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
122421|NCT01683812|P1|Participant Flow|Cranial Cup Arm|"Single arm
Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
122422|NCT01683812|O1|Outcome|Cranial Cup Arm|"Single arm
Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
122423|NCT01683812|O1|Outcome|Cranial Cup Arm|"Single arm
Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
122424|NCT01683812|E1|Reported Event|Cranial Cup Arm|"Single arm
Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
122425|NCT01683630|B3|Baseline|Total|Total of all reporting groups
136553|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
122426|NCT01683630|B2|Baseline|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
122427|NCT01683630|B1|Baseline|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
122428|NCT01683630|P2|Participant Flow|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
122429|NCT01683630|P1|Participant Flow|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
122430|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
122431|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
122432|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
122433|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
122434|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
122435|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
122436|NCT01683630|E2|Reported Event|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
122437|NCT01683630|E1|Reported Event|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
122438|NCT01683604|B1|Baseline|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122439|NCT01683604|P1|Participant Flow|Rheumatoid Arthritis (RA) Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122440|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122441|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122442|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122443|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122444|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122445|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122446|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122447|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122448|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122449|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122450|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122451|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122452|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122453|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122454|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122455|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122456|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122457|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122458|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122459|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
128520|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
122460|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122461|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122462|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122463|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122464|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122465|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122466|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122467|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122468|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122469|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122470|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122471|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122472|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122473|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122474|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122475|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122476|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122477|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122478|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122479|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122480|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122481|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122482|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122483|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122484|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122485|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122486|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122487|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122488|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122489|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122490|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122491|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122492|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122493|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122494|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122495|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122496|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122497|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122498|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122499|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122500|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122501|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122502|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122503|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122504|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122505|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122506|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122507|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122508|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122509|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122510|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122511|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122512|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122513|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122514|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122515|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122516|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122517|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122518|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122519|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122520|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122521|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122522|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122523|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122524|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122525|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122526|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122527|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122528|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122529|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122530|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122531|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122532|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122533|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122534|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122535|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122536|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122537|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122538|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122539|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122540|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122541|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122542|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122543|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122544|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122545|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122546|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122547|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122548|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122549|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122550|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122551|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122552|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122553|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122554|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122555|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122556|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122557|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122558|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122559|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122560|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122561|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122562|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122563|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122564|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122565|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122566|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122567|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122568|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122656|NCT01683409|E12|Reported Event|Baricitinib 0.75 mg/0.5 mg QD - Washout 2|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
122657|NCT01683409|E11|Reported Event|Placebo Washout 2|Placebo administered PO QD.
122569|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122570|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122571|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122572|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122573|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122574|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122575|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122576|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122577|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122578|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122579|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122580|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122581|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122582|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122583|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122584|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122585|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122586|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122587|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122588|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122589|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122590|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122591|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122592|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122593|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122594|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122595|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122596|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122597|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
122598|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122658|NCT01683409|E10|Reported Event|Baricitinib 4 mg/2.75 mg - Washout 1|Baricitinib 4 mg or 2.75 mg administered PO QD.
122771|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
122599|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122600|NCT01683604|E1|Reported Event|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
122601|NCT01683526|B3|Baseline|Total|Total of all reporting groups
122602|NCT01683526|B2|Baseline|Video Laryngoscopy|"Intubation will be done using video laryngoscopy
Video laryngoscopy (Glidescope)"
122603|NCT01683526|B1|Baseline|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy
Direct laryngoscopy"
122604|NCT01683526|P2|Participant Flow|Video Laryngoscopy|"Intubation will be done using video laryngoscopy
Video laryngoscopy (Glidescope)"
122605|NCT01683526|P1|Participant Flow|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy
Direct laryngoscopy"
122606|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy
Video laryngoscopy (Glidescope)"
122607|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy
Direct laryngoscopy"
122608|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy
Video laryngoscopy (Glidescope)"
122609|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy
Direct laryngoscopy"
122610|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy
Video laryngoscopy (Glidescope)"
122611|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy
Direct laryngoscopy"
122612|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy
Video laryngoscopy (Glidescope)"
122613|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy
Direct laryngoscopy"
122614|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy
Video laryngoscopy (Glidescope)"
122615|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy
Direct laryngoscopy"
122616|NCT01683526|E2|Reported Event|Video Laryngoscopy|"Intubation will be done using video laryngoscopy
Video laryngoscopy (Glidescope)"
122617|NCT01683526|E1|Reported Event|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy
Direct laryngoscopy"
122618|NCT01683409|B6|Baseline|Total|Total of all reporting groups
122619|NCT01683409|B5|Baseline|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 administered PO QD.
122620|NCT01683409|B4|Baseline|Baricitinib 1.5 mg/1 mg QD|Baricitinib 1.5 mg or 1 mg administered PO QD.
122621|NCT01683409|B3|Baseline|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
122622|NCT01683409|B2|Baseline|Baricitinib 0.75/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
122623|NCT01683409|B1|Baseline|Placebo|Placebo administered PO QD.
122624|NCT01683409|P5|Participant Flow|Baricitinib 4 mg/2.75 mg|Baricitinib 4 milligram (mg) or 2.75 mg administered PO QD.
122625|NCT01683409|P4|Participant Flow|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
122626|NCT01683409|P3|Participant Flow|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO twice a day (BID).
122627|NCT01683409|P2|Participant Flow|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
122628|NCT01683409|P1|Participant Flow|Placebo|Placebo administered orally (PO) once a day (QD).
122629|NCT01683409|O4|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
122630|NCT01683409|O3|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
122631|NCT01683409|O2|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
122632|NCT01683409|O1|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
122633|NCT01683409|O5|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
122634|NCT01683409|O4|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
122635|NCT01683409|O3|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
122636|NCT01683409|O2|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
122637|NCT01683409|O1|Outcome|Placebo|Placebo administered PO QD.
122638|NCT01683409|O5|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
122639|NCT01683409|O4|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
122640|NCT01683409|O3|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
122641|NCT01683409|O2|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
122642|NCT01683409|O1|Outcome|Placebo|Placebo administered PO QD.
122643|NCT01683409|O5|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
122644|NCT01683409|O4|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
122645|NCT01683409|O3|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
122646|NCT01683409|O2|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
122647|NCT01683409|O1|Outcome|Placebo|Placebo administered PO QD.
122648|NCT01683409|O5|Outcome|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
122649|NCT01683409|O4|Outcome|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
122650|NCT01683409|O3|Outcome|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
122651|NCT01683409|O2|Outcome|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
122652|NCT01683409|O1|Outcome|Placebo|Placebo administered PO QD.
122653|NCT01683409|E15|Reported Event|Baricitinib 4 mg/2.75 mg - Washout 2|Baricitinib 4 mg or 2.75 mg administered PO QD.
122654|NCT01683409|E14|Reported Event|Baricitinib 1.5 mg/1 mg - Washout 2|Baricitinib 1.5 mg or 1 mg administered PO QD.
122655|NCT01683409|E13|Reported Event|Baricitinib 0.75 mg/0.5 mg BID - Washout 2|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
122659|NCT01683409|E9|Reported Event|Baricitinib 1.5 mg/1 mg - Washout 1|Baricitinib 1.5 mg or 1 mg administered PO QD.
122660|NCT01683409|E8|Reported Event|Baricitinib 0.75 mg/0.5 mg BID - Washout 1|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
122661|NCT01683409|E7|Reported Event|Baricitinib 0.75 mg/0.5 mg QD - Washout 1|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
122662|NCT01683409|E6|Reported Event|Placebo - Washout 1|Placebo administered PO QD.
122663|NCT01683409|E5|Reported Event|Baricitinib 4 mg/2.75 mg|Baricitinib 4 mg or 2.75 mg administered PO QD.
122664|NCT01683409|E4|Reported Event|Baricitinib 1.5 mg/1 mg|Baricitinib 1.5 mg or 1 mg administered PO QD.
122665|NCT01683409|E3|Reported Event|Baricitinib 0.75 mg/0.5 mg BID|Baricitinib 0.75 mg or 0.5 mg administered PO BID.
122666|NCT01683409|E2|Reported Event|Baricitinib 0.75 mg/0.5 mg QD|Baricitinib 0.75 mg or 0.5 mg administered PO QD.
122667|NCT01683409|E1|Reported Event|Placebo|Placebo administered PO QD.
122668|NCT01683383|B3|Baseline|Total|Total of all reporting groups
122669|NCT01683383|B2|Baseline|Device (Servo-regulated Cooling)|Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.
122670|NCT01683383|B1|Baseline|Control (Standard Cooling)|Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
122671|NCT01683383|P2|Participant Flow|Device (Servo-regulated Cooling)|Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.
122672|NCT01683383|P1|Participant Flow|Control (Standard Cooling)|Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
122673|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
122674|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
122675|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
122718|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122676|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
122677|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
122678|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
122679|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
122680|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
122681|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
122682|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
122683|NCT01683383|E2|Reported Event|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
122684|NCT01683383|E1|Reported Event|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
122685|NCT01683266|B3|Baseline|Total|Total of all reporting groups
122686|NCT01683266|B2|Baseline|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122687|NCT01683266|B1|Baseline|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122688|NCT01683266|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.
122689|NCT01683266|P1|Participant Flow|HOE901­-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.
122690|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122691|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122692|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122693|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122694|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122695|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122696|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122697|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122698|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122699|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122700|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122701|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122702|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122703|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122704|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122705|NCT01683266|O1|Outcome|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122706|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122707|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122708|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122709|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122710|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122711|NCT01683266|O1|Outcome|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122712|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122713|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122714|NCT01683266|E2|Reported Event|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122715|NCT01683266|E1|Reported Event|HOE901-­U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
122716|NCT01683058|B1|Baseline|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122717|NCT01683058|P1|Participant Flow|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122719|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122720|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122721|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122722|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122723|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122724|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122725|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122726|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122727|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122728|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122729|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122730|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122731|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122732|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122733|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122734|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122735|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122736|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122737|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122738|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122739|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122740|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122741|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122742|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122743|NCT01683058|E1|Reported Event|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
122744|NCT01683019|B4|Baseline|Total|Total of all reporting groups
122745|NCT01683019|B3|Baseline|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.
Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
122746|NCT01683019|B2|Baseline|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
122747|NCT01683019|B1|Baseline|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
122748|NCT01683019|P3|Participant Flow|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.
Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
122749|NCT01683019|P2|Participant Flow|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
122750|NCT01683019|P1|Participant Flow|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
122751|NCT01683019|O3|Outcome|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.
Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
122752|NCT01683019|O2|Outcome|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
122753|NCT01683019|O1|Outcome|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
122754|NCT01683019|E3|Reported Event|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.
Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
122755|NCT01683019|E2|Reported Event|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
122756|NCT01683019|E1|Reported Event|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
122757|NCT01682837|B1|Baseline|All Study Participants|Participants received the following study drug in random order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
122758|NCT01682837|P1|Participant Flow|All Study Participants|Participants received the following study drug in random order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder and Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Individual study drug assignments per randomization is provided in the comments for each study period.
122759|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
122760|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
122761|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
122762|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
122763|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
122764|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
122765|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
122766|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
122767|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
122768|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
122769|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
122770|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
122772|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
122773|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
122774|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
122775|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
122776|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
122777|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
122778|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
122779|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
122780|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
122781|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
122782|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
122783|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
122784|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
122785|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
122786|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
122787|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
122788|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
122789|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
122790|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
122791|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
122792|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
122793|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
122794|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
122796|NCT01682837|E3|Reported Event|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
122797|NCT01682837|E2|Reported Event|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
122798|NCT01682837|E1|Reported Event|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
122799|NCT01682759|B3|Baseline|Total|Total of all reporting groups
122800|NCT01682759|B2|Baseline|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
122801|NCT01682759|B1|Baseline|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
122802|NCT01682759|P2|Participant Flow|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
122803|NCT01682759|P1|Participant Flow|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
122804|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
122805|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
122806|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
122807|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
122808|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
122809|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
122810|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
122811|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
122812|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
122813|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
122814|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
122815|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
122816|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
122899|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
122817|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
122818|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
122819|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
122820|NCT01682759|E2|Reported Event|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
122821|NCT01682759|E1|Reported Event|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
122822|NCT01682720|B5|Baseline|Total|Total of all reporting groups
122823|NCT01682720|B4|Baseline|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
122824|NCT01682720|B3|Baseline|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
122825|NCT01682720|B2|Baseline|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
122826|NCT01682720|B1|Baseline|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + placebo to match RBV for 12 weeks in participants with genotype 2 or 3 HCV infection.
122827|NCT01682720|P4|Participant Flow|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
122828|NCT01682720|P3|Participant Flow|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
122829|NCT01682720|P2|Participant Flow|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
122830|NCT01682720|P1|Participant Flow|Placebo 12 Weeks (GT2/3)|Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT)2 or 3 HCV infection.
122831|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
122832|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
122833|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
122834|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
122835|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
122836|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
122837|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
122838|NCT01682720|O2|Outcome|SOF 12 Weeks (GT2/3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
122839|NCT01682720|O1|Outcome|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
122840|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
122841|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
122842|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
122843|NCT01682720|E3|Reported Event|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
122844|NCT01682720|E2|Reported Event|SOF 12 Weeks (GT2/3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
122845|NCT01682720|E1|Reported Event|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
122846|NCT01682681|B1|Baseline|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
122847|NCT01682681|P1|Participant Flow|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
122848|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
122849|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
122850|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
122851|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
122900|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
122852|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
122853|NCT01682681|E1|Reported Event|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
122854|NCT01682642|B3|Baseline|Total|Total of all reporting groups
122855|NCT01682642|B2|Baseline|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
122856|NCT01682642|B1|Baseline|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
122857|NCT01682642|P2|Participant Flow|Vaporization Only|After surgical vaporization of the endometriosis , patients start immediately with IVF treatment (without additional treatment).
122858|NCT01682642|P1|Participant Flow|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months immediately following the start of IVF treatment.
122859|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
122860|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following ivf treatment.
122861|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.
122862|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start IVF treatment.
122863|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.
122864|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVFtreatment.
122865|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
122866|NCT01682642|O1|Outcome|Zoladex|
122867|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
122868|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVF treatment.
122869|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
122870|NCT01682642|O1|Outcome|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
136554|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
122871|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
122872|NCT01682642|O1|Outcome|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
122873|NCT01682642|E2|Reported Event|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
122874|NCT01682642|E1|Reported Event|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
122875|NCT01682603|B1|Baseline|Botulinum Toxin A|"BoNT-A (BOTOX 300U)
Botulinum toxin A: BoNT-A (BOTOX 300U)"
122876|NCT01682603|P1|Participant Flow|Botulinum Toxin A|Botulinum toxin A (BoNT-A) (BOTOX 300U)
122877|NCT01682603|O2|Outcome|Pre-Non Autonomic Dysreflexia|Baseline Non autonomic dysreflexia
122878|NCT01682603|O1|Outcome|Pre-Autonomic Dysreflexia|Baseline Autonomic dysreflexia
122879|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)
Botulinum toxin A: BoNT-A (BOTOX 300U)"
122880|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)
Botulinum toxin A: BoNT-A (BOTOX 300U)"
122881|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)
Botulinum toxin A: BoNT-A (BOTOX 300U)"
122882|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)
Botulinum toxin A: BoNT-A (BOTOX 300U)"
122883|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)
Botulinum toxin A: BoNT-A (BOTOX 300U)"
122884|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)
Botulinum toxin A: BoNT-A (BOTOX 300U)"
122885|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)
Botulinum toxin A: BoNT-A (BOTOX 300U)"
122886|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)
Botulinum toxin A: BoNT-A (BOTOX 300U)"
122887|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)
Botulinum toxin A: BoNT-A (BOTOX 300U)"
122888|NCT01682603|E1|Reported Event|Botulinum Toxin A|"BoNT-A (BOTOX 300U)
Botulinum toxin A: BoNT-A (BOTOX 300U)"
122889|NCT01682538|B1|Baseline|Overall Study|All treatment arms
122890|NCT01682538|P1|Participant Flow|All Treatment Groups|"All participants received all study treatments in a randomized fashion. Subjects were allocated to one of the following treatment sequences (2 subjects to each sequence):
A B C; B C A; C A B; C B A; A C B; B A C where A=Orfadin capsules, single dose, 30 mg; B=Orfadin suspension, single dose 30 mg, fasting; C=Orfadin suspension, single dose 30 mg, fed"
122891|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
122892|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
122893|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
122894|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
122895|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension, 4 mg/mL, single dose, 30 mg (7.5 mL)
122896|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
122897|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
122898|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
122901|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
122902|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
122903|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
122904|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
122905|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
122906|NCT01682538|O2|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
122907|NCT01682538|O1|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
122908|NCT01682538|O2|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
122909|NCT01682538|O1|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
122910|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
122911|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
122912|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
122913|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
122914|NCT01682538|E3|Reported Event|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
122915|NCT01682538|E2|Reported Event|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
122916|NCT01682538|E1|Reported Event|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
122917|NCT01682460|B1|Baseline|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122918|NCT01682460|P1|Participant Flow|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122919|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122920|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122921|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122922|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122923|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122924|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122925|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122926|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122927|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122928|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122929|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122930|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122931|NCT01682460|E1|Reported Event|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
122932|NCT01682135|B4|Baseline|Total|Total of all reporting groups
122933|NCT01682135|B3|Baseline|Cohort 3 - 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
122934|NCT01682135|B2|Baseline|Cohort 2 - 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 3. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
122935|NCT01682135|B1|Baseline|Cohort 1 - 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 2. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
122936|NCT01682135|P3|Participant Flow|Cohort 3 - 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
122937|NCT01682135|P2|Participant Flow|Cohort 2 - 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
122938|NCT01682135|P1|Participant Flow|Cohort 1 - 6 mg/kg/2w Ramucirumab|6 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
122939|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
122940|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
122941|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
122942|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
122943|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
122944|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
122945|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
122946|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
122947|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
122948|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
122949|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
122950|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
122951|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
122952|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
122953|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
122954|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
122955|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
122956|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
122957|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
122958|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
122959|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
122960|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
122961|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
122962|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
122963|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
122964|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
122965|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
122966|NCT01682135|E3|Reported Event|Cohort 3 - 8mg/kg/2w Ramucirumab|8mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
122967|NCT01682135|E2|Reported Event|Cohort 2 - 10mg/kg/3w Ramucirumab|10mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
122968|NCT01682135|E1|Reported Event|Cohort 1 - 6mg/kg/2w Ramucirumab|6mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
122969|NCT01682031|B3|Baseline|Total|Total of all reporting groups
122970|NCT01682031|B2|Baseline|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122971|NCT01682031|B1|Baseline|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122972|NCT01682031|P2|Participant Flow|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122973|NCT01682031|P1|Participant Flow|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122974|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122975|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122976|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122977|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
123068|NCT01681472|E3|Reported Event|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
136555|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
122978|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122979|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122980|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122981|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122982|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122983|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122984|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122985|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122986|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122987|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
123021|NCT01681576|B2|Baseline|Valsartan 320mg|Period 1: 4 weeks treatment with Valsartan 320mg QD, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with LCZ696 400mg QD
123489|NCT01680159|B5|Baseline|Total|Total of all reporting groups
122988|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122989|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122990|NCT01682031|E2|Reported Event|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122991|NCT01682031|E1|Reported Event|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies"
122992|NCT01681849|B4|Baseline|Total|Total of all reporting groups
122993|NCT01681849|B3|Baseline|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD served as a control group and completed baseline assessments
Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
122994|NCT01681849|B2|Baseline|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.
Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
123069|NCT01681472|E2|Reported Event|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
123070|NCT01681472|E1|Reported Event|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
123071|NCT01681368|B1|Baseline|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
122995|NCT01681849|B1|Baseline|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.
Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
122996|NCT01681849|P3|Participant Flow|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD served as a control group and completed baseline assessments
Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
122997|NCT01681849|P2|Participant Flow|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.
Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
122998|NCT01681849|P1|Participant Flow|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.
Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
122999|NCT01681849|O2|Outcome|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.
Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
123000|NCT01681849|O1|Outcome|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.
Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
123001|NCT01681849|O2|Outcome|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.
Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
123650|NCT01679197|E1|Reported Event|Treatment|"Metreleptin
Metreleptin"
123002|NCT01681849|O1|Outcome|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.
Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
123003|NCT01681849|E3|Reported Event|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD will serve as a control group and complete baseline assessments
Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
123004|NCT01681849|E2|Reported Event|Placebo Group|"Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.
Placebo: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Paroxetine: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
123005|NCT01681849|E1|Reported Event|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.
Paroxetine: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
123006|NCT01681628|B3|Baseline|Total|Total of all reporting groups
123072|NCT01681368|P1|Participant Flow|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
128521|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
123007|NCT01681628|B2|Baseline|Wait List|"Delayed intervention.
No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.
Both groups were invited to attend 19 mo the later."
123008|NCT01681628|B1|Baseline|Thought Field Therapy (TFT)|"Thought Field Therapy delivered by trained community leaders.
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.
Both groups were invited to attend 19 months later"
123009|NCT01681628|P2|Participant Flow|Wait List|"Delayed intervention.
No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
123010|NCT01681628|P1|Participant Flow|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
123011|NCT01681628|O1|Outcome|Wait List Group|Those in the wait list, who had attended for their second immediate pre-treatment assessment and attended for assessment 19 months later.
123012|NCT01681628|O1|Outcome|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
123013|NCT01681628|O3|Outcome|Wait List: Thought Field Therapy|After two control assessments at times 1 and 2, the wait list group were treated and re-assessed one week later at time 3. Non-attenders at time 3 were excluded from analysis.
123014|NCT01681628|O2|Outcome|Wait List no Treatment|"No intervention prior to assessment after one week (pre-test 2).
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
123015|NCT01681628|O1|Outcome|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
123016|NCT01681628|O3|Outcome|Wait-list: Thought Field Therapy|"Received thought field therapy after second assessment (time 2) and re-assessed one week later (time 3).
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
123017|NCT01681628|O2|Outcome|Wait List: no Therapy|"No thought field therapy intervention prior to assessment after one week (pre-test 2).
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
123018|NCT01681628|O1|Outcome|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
123019|NCT01681628|E1|Reported Event|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.
Both groups were invited to attend 19 months later"
123020|NCT01681576|B3|Baseline|Total|Total of all reporting groups
123022|NCT01681576|B1|Baseline|LCZ696 Followed by Valsartan|Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
123023|NCT01681576|P2|Participant Flow|Valsartan Followed by LCZ696|Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks
123024|NCT01681576|P1|Participant Flow|LCZ696 Followed by Valsartan|Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
123025|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
123026|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
123027|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
123028|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
123029|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
123030|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
123031|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
123032|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
123033|NCT01681576|O2|Outcome|Valsartan -ALL|Valsartan 320mg QD
123034|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg QD
123035|NCT01681576|E2|Reported Event|Valsartan 320 mg QD|Valsartan 320 mg QD
123036|NCT01681576|E1|Reported Event|LCZ696 400 mg QD|LCZ696 400 mg QD
123037|NCT01681511|B3|Baseline|Total|Total of all reporting groups
123038|NCT01681511|B2|Baseline|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
123039|NCT01681511|B1|Baseline|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
123040|NCT01681511|P2|Participant Flow|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
123041|NCT01681511|P1|Participant Flow|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
123042|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
123043|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
123044|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
123045|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
123046|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
123047|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
123048|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
123049|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
123050|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
123051|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
123216|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123052|NCT01681511|E2|Reported Event|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
123053|NCT01681511|E1|Reported Event|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
123054|NCT01681472|B5|Baseline|Total|Total of all reporting groups
123055|NCT01681472|B4|Baseline|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
123056|NCT01681472|B3|Baseline|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
123057|NCT01681472|B2|Baseline|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
123058|NCT01681472|B1|Baseline|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
123059|NCT01681472|P4|Participant Flow|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
123060|NCT01681472|P3|Participant Flow|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
123061|NCT01681472|P2|Participant Flow|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
123062|NCT01681472|P1|Participant Flow|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
123063|NCT01681472|O4|Outcome|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
123064|NCT01681472|O3|Outcome|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
123065|NCT01681472|O2|Outcome|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
123066|NCT01681472|O1|Outcome|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
123067|NCT01681472|E4|Reported Event|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
123073|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
123074|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
123075|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
123076|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
123077|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
123078|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
123079|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
123080|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
123081|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
123082|NCT01681368|E1|Reported Event|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm
Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
123083|NCT01681277|B6|Baseline|Total|Total of all reporting groups
123084|NCT01681277|B5|Baseline|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
123085|NCT01681277|B4|Baseline|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123086|NCT01681277|B3|Baseline|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123087|NCT01681277|B2|Baseline|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123088|NCT01681277|B1|Baseline|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
123651|NCT01679028|B7|Baseline|Total|Total of all reporting groups
123089|NCT01681277|P5|Participant Flow|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
123090|NCT01681277|P4|Participant Flow|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123091|NCT01681277|P3|Participant Flow|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123092|NCT01681277|P2|Participant Flow|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123093|NCT01681277|P1|Participant Flow|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
123094|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
123095|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123147|NCT01681121|E1|Reported Event|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks
ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
123148|NCT01681095|B3|Baseline|Total|Total of all reporting groups
123096|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123097|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123098|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
123099|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123100|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123101|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123102|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
123103|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123104|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123105|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123106|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
123652|NCT01679028|B6|Baseline|T89 Group C|T89 225mg bid for 14 days
123107|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123108|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123109|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123110|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
123111|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123112|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123229|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123467|NCT01680328|O1|Outcome|Injection Volume of 1600 μL|Acceptance of pain was assessed in each subject for all injections.
123113|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123114|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
123115|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123116|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123117|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123118|NCT01681277|O5|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
123119|NCT01681277|O4|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123120|NCT01681277|O3|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123121|NCT01681277|O2|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123122|NCT01681277|O1|Outcome|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
123123|NCT01681277|O5|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
123124|NCT01681277|O4|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123125|NCT01681277|O3|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123126|NCT01681277|O2|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123127|NCT01681277|O1|Outcome|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
123128|NCT01681277|E5|Reported Event|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
123129|NCT01681277|E4|Reported Event|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123130|NCT01681277|E3|Reported Event|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123131|NCT01681277|E2|Reported Event|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
123132|NCT01681277|E1|Reported Event|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
123133|NCT01681212|B1|Baseline|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
123134|NCT01681212|P1|Participant Flow|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression, unacceptable toxicity, or withdrawal of consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
123135|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
123136|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
123137|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
123217|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123218|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123138|NCT01681212|E1|Reported Event|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
123139|NCT01681121|B3|Baseline|Total|Total of all reporting groups
123140|NCT01681121|B2|Baseline|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks
Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
123141|NCT01681121|B1|Baseline|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks
ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
123142|NCT01681121|P2|Participant Flow|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks
Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
123143|NCT01681121|P1|Participant Flow|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks
ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
123144|NCT01681121|O2|Outcome|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks
Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
123145|NCT01681121|O1|Outcome|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks
ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
123146|NCT01681121|E2|Reported Event|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks
Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
128522|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
123149|NCT01681095|B2|Baseline|Custiodiol HTK|"55 participants were randomized to Custodiol HTK. Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123150|NCT01681095|B1|Baseline|Standard Cold Blood Cardioplegia|"55 participants were randomized to Standard cold blood cardioplegia. Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123151|NCT01681095|P2|Participant Flow|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123152|NCT01681095|P1|Participant Flow|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123153|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123154|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123219|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123155|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123156|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123157|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123230|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123231|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123158|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123159|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123160|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123161|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123162|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123163|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123164|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123654|NCT01679028|B4|Baseline|T89 Group B|T89 300mg single dose
123165|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123166|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123167|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123168|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123169|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123170|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123171|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123172|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123173|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123174|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123655|NCT01679028|B3|Baseline|Placebo Group B|Placebo 300mg single dose
123175|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123176|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123177|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123178|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123179|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123180|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123181|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123182|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123183|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123184|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123656|NCT01679028|B2|Baseline|T89 Group A|T89 150mg single dose
123185|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123186|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123187|NCT01681095|E2|Reported Event|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.
After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
123188|NCT01681095|E1|Reported Event|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.
Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
123189|NCT01681069|B3|Baseline|Total|Total of all reporting groups
123190|NCT01681069|B2|Baseline|Placebo|"2 tablets twice a day
Placebo"
123191|NCT01681069|B1|Baseline|IQP-VV-102|"2 tablets twice a day
IQP-VV-102"
123192|NCT01681069|P2|Participant Flow|Placebo|"2 tablets twice a day
Placebo"
123193|NCT01681069|P1|Participant Flow|IQP-VV-102|"2 tablets twice a day
IQP-VV-102"
123194|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day
Placebo"
123195|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day
IQP-VV-102"
123196|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day
Placebo"
123197|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day
IQP-VV-102"
123198|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day
Placebo"
123199|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day
IQP-VV-102"
123200|NCT01681069|E2|Reported Event|Placebo|"2 tablets twice a day
Placebo"
123201|NCT01681069|E1|Reported Event|IQP-VV-102|"2 tablets twice a day
IQP-VV-102"
123202|NCT01681004|B3|Baseline|Total|Total of all reporting groups
123203|NCT01681004|B2|Baseline|Non-Surgical Management|"Medications, SI joint injection, physical therapy and RF ablation of SI joint
Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123204|NCT01681004|B1|Baseline|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123205|NCT01681004|P2|Participant Flow|Non-Surgical Management|"Medications, SI joint injection, physical therapy and RF ablation of SI joint
Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123206|NCT01681004|P1|Participant Flow|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123207|NCT01681004|O2|Outcome|Non-Surgical Management|This arm includes all subjects randomized to NSM. Many of these subjects crossed over to treatment after 6 months of NSM.
123208|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123209|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123210|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123211|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123212|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123213|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123214|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123215|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123657|NCT01679028|B1|Baseline|Placebo Group A|Placebo 150mg single dose
123220|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123221|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months..
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123222|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123223|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123224|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123225|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123226|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123227|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123228|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
128523|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
123232|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123233|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123234|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123235|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123236|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123237|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123238|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123239|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123240|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123241|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123242|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123243|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123244|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123245|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123246|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123247|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123248|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123249|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123250|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123251|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123252|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
126933|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
123253|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123254|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123255|NCT01681004|O2|Outcome|Non-Surgical Management|"This arm includes all subjects randomized to NSM with reporting to 6 months only.
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete."
123256|NCT01681004|O1|Outcome|iFuse Implant System|"Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery"
123257|NCT01681004|E2|Reported Event|Non-Surgical Management|"This arm includes all subjects randomized to NSM followed to 6 months
Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation."
123258|NCT01681004|E1|Reported Event|iFuse Implant System|Surgical placement of iFuse implants in the affected SI joint iFuse Implant System: Placement of iFuse implant system via surgery
123259|NCT01680991|B4|Baseline|Total|Total of all reporting groups
123260|NCT01680991|B3|Baseline|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123261|NCT01680991|B2|Baseline|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123262|NCT01680991|B1|Baseline|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123263|NCT01680991|P3|Participant Flow|FL: 1000 mg Obinutuzumab|Participants with follicular lymphoma (FL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
136556|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
123264|NCT01680991|P2|Participant Flow|DLBCL: 1000 mg Obinutuzumab|Participants with diffuse large B-cell lymphoma (DLBCL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123265|NCT01680991|P1|Participant Flow|CLL: 1000 mg Obinutuzumab|Participants with chronic lymphocytic leukemia (CLL) received 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123266|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123267|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123268|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123269|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123270|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123271|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123272|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123273|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123274|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123275|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123276|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123277|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123278|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123394|NCT01680549|O2|Outcome|Placebo|Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days
123279|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123280|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123281|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123282|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123283|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123284|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123285|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123286|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123287|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123288|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123289|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123290|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123291|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123292|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123293|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123294|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123295|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123296|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123297|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123298|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123299|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123300|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123301|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123302|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123395|NCT01680549|O1|Outcome|Gabapentin|Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
123396|NCT01680549|O2|Outcome|Gabapentin|Active pain medicine
123303|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123304|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123305|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123306|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123307|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123308|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123309|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123310|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123598|NCT01679613|E1|Reported Event|Ketoconazole|In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2
123311|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123312|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123313|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123314|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123315|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123316|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123317|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123318|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123319|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123320|NCT01680991|E3|Reported Event|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123321|NCT01680991|E2|Reported Event|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
123322|NCT01680991|E1|Reported Event|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
123323|NCT01680900|B3|Baseline|Total|Total of all reporting groups
123324|NCT01680900|B2|Baseline|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules."
123325|NCT01680900|B1|Baseline|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
123326|NCT01680900|P2|Participant Flow|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules."
123327|NCT01680900|P1|Participant Flow|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
123328|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules."
123397|NCT01680549|O1|Outcome|Placebo|Placebo- Comparator
123398|NCT01680549|E2|Reported Event|Gabapentin|Active pain control medicine
123329|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
123330|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules."
123331|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
123332|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules."
123333|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
123334|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules."
123335|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
123336|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules."
123337|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
123338|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules."
123599|NCT01679600|B3|Baseline|Total|Total of all reporting groups
128524|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
123339|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
123340|NCT01680900|E2|Reported Event|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules."
123341|NCT01680900|E1|Reported Event|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
123342|NCT01680861|B3|Baseline|Total|Total of all reporting groups
123343|NCT01680861|B2|Baseline|Tacrolimus/EC-MPS|our standard maintenance arm.
123344|NCT01680861|B1|Baseline|Tacrolimus/Everolimus|our experimental maintenance arm.
123345|NCT01680861|P2|Participant Flow|Tacrolimus/EC-MPS|our standard maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target EC-MPS dose: 720 mg PO BID (as tolerated).
123346|NCT01680861|P1|Participant Flow|Tacrolimus/Everolimus|our experimental maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target 12-hr Everolimus trough level: 3-8 ng/mL.
123347|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
123348|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
123349|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
123350|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
123351|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
123352|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
123353|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
123354|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
123355|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
123356|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
123357|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm.
123358|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm.
123359|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm.
123360|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm.
123361|NCT01680861|E2|Reported Event|Tacrolimus/EC-MPS|our standard maintenance arm
123362|NCT01680861|E1|Reported Event|Tacrolimus/Everolimus|our experimental maintenance arm
123363|NCT01680848|B1|Baseline|JDPBRN Dentists|"Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.
The JDPBRN aims to allow dentists to investigate research questions and share experiences and expertise and recruited its members from the JDPBRN website."
123364|NCT01680848|P1|Participant Flow|JDPBRN Dentists|Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.
123365|NCT01680848|O1|Outcome|High Caries Risk|The proportion of dentists who indicated surgical intervention into enamel was 74% (N = 138) in the high-caries-risk scenario.
123366|NCT01680848|E1|Reported Event|This is an Observational Study|This is an observational study. We don't have two arms.
123367|NCT01680783|B3|Baseline|Total|Total of all reporting groups
123368|NCT01680783|B2|Baseline|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
123369|NCT01680783|B1|Baseline|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
123399|NCT01680549|E1|Reported Event|Placebo|placebo comparator
123653|NCT01679028|B5|Baseline|Placebo Group C|Placebo 225mg bid for 14 days
123370|NCT01680783|P2|Participant Flow|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
123371|NCT01680783|P1|Participant Flow|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
123372|NCT01680783|O2|Outcome|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
123373|NCT01680783|O1|Outcome|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
123413|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
123414|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
123374|NCT01680783|E2|Reported Event|Non Invasive Ventilation Via Helmet|"Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
123375|NCT01680783|E1|Reported Event|Usual Care|"Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask"
123376|NCT01680666|B3|Baseline|Total|Total of all reporting groups
123377|NCT01680666|B2|Baseline|Ultrasound Guided|All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia were approached for inclusion in the study. Children known preoperatively to have non-patency of central veins or coagulopathy were excluded from the study. Patients with previous multiple line placements were screened for deep venous thrombosis using Doppler ultrasound. Patients were enrolled by a member of the study team, and informed consent for the study was obtained from the patient’s legal guardian.
123378|NCT01680666|B1|Baseline|Landmark Guided|All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia were approached for inclusion in the study. Children known preoperatively to have non-patency of central veins or coagulopathy were excluded from the study. Patients with previous multiple line placements were screened for deep venous thrombosis using Doppler ultrasound. Patients were enrolled by a member of the study team, and informed consent for the study was obtained from the patient’s legal guardian.
123379|NCT01680666|P2|Participant Flow|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
123380|NCT01680666|P1|Participant Flow|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
123381|NCT01680666|O2|Outcome|Ultrasound Guided|Success of central venous cannulation at first attempt
123382|NCT01680666|O1|Outcome|Landmark Technique|Success of central venous cannulation at first attempt
123383|NCT01680666|E2|Reported Event|Ultrasound|Success of central venous cannulation at first attempt
123384|NCT01680666|E1|Reported Event|Landmark|Success of central venous cannulation at first attempt
123385|NCT01680549|B3|Baseline|Total|Total of all reporting groups
123386|NCT01680549|B2|Baseline|Placebo|"Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days
Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days."
123387|NCT01680549|B1|Baseline|Gabapentin|"Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days."
123388|NCT01680549|P2|Participant Flow|Placebo|Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days
123389|NCT01680549|P1|Participant Flow|Gabapentin|Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
123390|NCT01680549|O2|Outcome|Gabapentin|Active pain control medicine
123391|NCT01680549|O1|Outcome|Placebo|Placebo comparator
123392|NCT01680549|O2|Outcome|Gabapentin|Active pain control Medicine
123393|NCT01680549|O1|Outcome|Placebo|Placebo- comparator
123400|NCT01680497|B1|Baseline|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
123401|NCT01680497|P1|Participant Flow|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
123402|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
123403|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
123404|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
123405|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
123406|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
123407|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
123408|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
123409|NCT01680497|E1|Reported Event|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
123410|NCT01680458|B1|Baseline|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
123411|NCT01680458|P1|Participant Flow|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
123412|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
123415|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
123416|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
123417|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
123418|NCT01680458|E1|Reported Event|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
123419|NCT01680341|B3|Baseline|Total|Total of all reporting groups
123420|NCT01680341|B2|Baseline|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
123421|NCT01680341|B1|Baseline|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
123422|NCT01680341|P2|Participant Flow|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
123423|NCT01680341|P1|Participant Flow|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
123424|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
123425|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
123426|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
123526|NCT01680016|O1|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123427|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
123428|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
123429|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
123464|NCT01680328|O4|Outcome|Injection Volume of 400 μL|Acceptance of pain was assessed in each subject for all injections.
123465|NCT01680328|O3|Outcome|Injection Volume of 800 μL|Acceptance of pain was assessed in each subject for all injections.
123466|NCT01680328|O2|Outcome|Injection Volume of 1200 μL|Acceptance of pain was assessed in each subject for all injections.
128525|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
123430|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
123431|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
123432|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
123433|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
123434|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
123435|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
123436|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
123437|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
123438|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
123455|NCT01680328|O4|Outcome|Injection Volume 800 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123439|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
123440|NCT01680341|E2|Reported Event|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
123441|NCT01680341|E1|Reported Event|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
123442|NCT01680328|B1|Baseline|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
123443|NCT01680328|P1|Participant Flow|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
123444|NCT01680328|O7|Outcome|Injection Speed at 150 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123445|NCT01680328|O6|Outcome|Injection Speed at 300 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123446|NCT01680328|O5|Outcome|Injection Speed at 450 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123447|NCT01680328|O4|Outcome|Injection Volume 400 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123448|NCT01680328|O3|Outcome|Injection Volume 800 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123449|NCT01680328|O2|Outcome|Injection Volume 1600 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123450|NCT01680328|O1|Outcome|Thighs: Injection Region-5 s.c Injections+1 Needle Insertion|Backflow (uL) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
123451|NCT01680328|O8|Outcome|Injection Speed at 150 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123452|NCT01680328|O7|Outcome|Injection Speed at 300 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123453|NCT01680328|O6|Outcome|Injection Speed at 450 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123454|NCT01680328|O5|Outcome|Injection Volume 400 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123488|NCT01680172|E1|Reported Event|Ketamine|"Single dose of ketamine (0.5 mg/kg)
Ketamine: Single dose of ketamine (0.5 mg/kg)"
123456|NCT01680328|O3|Outcome|Injection Volume 1200 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123457|NCT01680328|O2|Outcome|Injection Volume 1600 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123458|NCT01680328|O1|Outcome|Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion|Backflow (uL) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
123459|NCT01680328|O2|Outcome|Abdomen|Acceptance of pain was assessed in each subject for all injections in the abdomen.
123460|NCT01680328|O1|Outcome|Thighs|Acceptance of pain was assessed in each subject for all injections in the thighs.
123461|NCT01680328|O3|Outcome|Injection Speed at 150 μL/s|Acceptance of pain was assessed in each subject for all injections.
123462|NCT01680328|O2|Outcome|Injection Speed at 300 μL/s|Acceptance of pain was assessed in each subject for all injections.
123463|NCT01680328|O1|Outcome|Injection Speed at 450 μL/s|Acceptance of pain was assessed in each subject for all injections.
136557|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
123468|NCT01680328|O9|Outcome|Injection Speed at 150 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123469|NCT01680328|O8|Outcome|Injection Speed at 300 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123470|NCT01680328|O7|Outcome|Injection Speed at 450 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123471|NCT01680328|O6|Outcome|Injection Volume 400 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123472|NCT01680328|O5|Outcome|Injection Volume 800 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123473|NCT01680328|O4|Outcome|Injection Volume 1200 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123474|NCT01680328|O3|Outcome|Injection Volume 1600 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
123475|NCT01680328|O2|Outcome|Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion|Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
123476|NCT01680328|O1|Outcome|Thighs: Injection Region-5 s.c Injections+1 Needle Insertion|Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
123477|NCT01680328|E1|Reported Event|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
123478|NCT01680172|B3|Baseline|Total|Total of all reporting groups
123479|NCT01680172|B2|Baseline|Placebo|"Single dose of placebo
Placebo: Single dose of placebo"
123480|NCT01680172|B1|Baseline|Ketamine|"Single dose of ketamine (0.5 mg/kg)
Ketamine: Single dose of ketamine (0.5 mg/kg)"
123481|NCT01680172|P2|Participant Flow|Placebo|"Single dose of placebo
Placebo: Single dose of placebo"
123482|NCT01680172|P1|Participant Flow|Ketamine|"Single dose of ketamine (0.5 mg/kg)
Ketamine: Single dose of ketamine (0.5 mg/kg)"
123483|NCT01680172|O2|Outcome|Placebo|"Single dose of placebo
Placebo: Single dose of placebo"
123484|NCT01680172|O1|Outcome|Ketamine|"Single dose of ketamine (0.5 mg/kg)
Ketamine: Single dose of ketamine (0.5 mg/kg)"
123485|NCT01680172|O2|Outcome|Placebo|"Single dose of placebo
Placebo: Single dose of placebo"
123486|NCT01680172|O1|Outcome|Ketamine|"Single dose of ketamine (0.5 mg/kg)
Ketamine: Single dose of ketamine (0.5 mg/kg)"
123487|NCT01680172|E2|Reported Event|Placebo|"Single dose of placebo
Placebo: Single dose of placebo"
123490|NCT01680159|B4|Baseline|Psoriatic Erythroderma|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123491|NCT01680159|B3|Baseline|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123492|NCT01680159|B2|Baseline|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123493|NCT01680159|B1|Baseline|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123494|NCT01680159|P1|Participant Flow|TA-650|During the normal dose period, patients received doses of TA-650 5 mg per 1 kg body weight as a slow intravenous infusion over at least 2 hours on the treatment day at week 0, and at week 8 (if patients were not assessed as being either “efficacy attenuated” or “efficacy maintained” at week 8 of the normal dose period).
123495|NCT01680159|O1|Outcome|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123496|NCT01680159|O1|Outcome|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123497|NCT01680159|O1|Outcome|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123600|NCT01679600|B2|Baseline|RATE|"Robotics-assisted treadmill exercise
Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
123498|NCT01680159|O5|Outcome|Psoriatic Erythroderma|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123499|NCT01680159|O4|Outcome|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123500|NCT01680159|O3|Outcome|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123501|NCT01680159|O2|Outcome|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123502|NCT01680159|O1|Outcome|Overall|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123503|NCT01680159|O5|Outcome|Psoriatic Erythroderma|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123504|NCT01680159|O4|Outcome|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123505|NCT01680159|O3|Outcome|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123506|NCT01680159|O2|Outcome|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123507|NCT01680159|O1|Outcome|Overall|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
123508|NCT01680159|E10|Reported Event|TA-650（Entire Evaluation Period）Psoriatic Arthritis|Psoriatic Arthritis
123509|NCT01680159|E9|Reported Event|TA-650（Entire Evaluation Period）Plaque Psoriasis|Plaque Psoriasis
123510|NCT01680159|E8|Reported Event|TA-650（Dose Escalation Period）Psoriatic Erythroderma|Psoriatic Erythroderma
123511|NCT01680159|E7|Reported Event|TA-650（Dose Escalation Period）Pustular Psoriasis|Pustular Psoriasis
123512|NCT01680159|E6|Reported Event|TA-650（Dose Escalation Period）Psoriatic Arthritis|Psoriatic Arthritis
123513|NCT01680159|E5|Reported Event|TA-650（Dose Escalation Period）Plaque Psoriasis|Plaque Psoriasis
123514|NCT01680159|E4|Reported Event|TA-650（Dose Escalation Period）Overall|Overall(Plaque Psoriasis・Psoriatic Arthritis・Pustular Psoriasis・Psoriatic Erythroderma)
123515|NCT01680159|E3|Reported Event|TA-650（Normal Dose Period）Psoriatic Arthritis|Psoriatic Arthritis
123516|NCT01680159|E2|Reported Event|TA-650（Normal Dose Period）Plaque Psoriasis|Plaque Psoriasis
123517|NCT01680159|E1|Reported Event|TA-650（Normal Dose Period）Overall|Overall(Plaque Psoriasis・Psoriatic Arthritis)
123518|NCT01680016|B3|Baseline|Total|Total of all reporting groups
123519|NCT01680016|B2|Baseline|Essen|Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123520|NCT01680016|B1|Baseline|Zagreb|Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123521|NCT01680016|P4|Participant Flow|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123522|NCT01680016|P3|Participant Flow|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123523|NCT01680016|P2|Participant Flow|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123524|NCT01680016|P1|Participant Flow|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
123525|NCT01680016|O2|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123527|NCT01680016|O2|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123528|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
123529|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123530|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123531|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123532|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123533|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123534|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123535|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123536|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123537|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123538|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123539|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123540|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123541|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123542|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123543|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123544|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123545|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123546|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123547|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123548|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123549|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123550|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123551|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123552|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123553|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123554|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123555|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123556|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123557|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123558|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123559|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123560|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123561|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123562|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123563|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123564|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123565|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123566|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123649|NCT01679197|O1|Outcome|Treatment|"Metreleptin
Metreleptin"
123567|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123568|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123569|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123570|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123571|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123572|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123573|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123574|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123575|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123576|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123577|NCT01680016|O2|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123578|NCT01680016|O1|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
123579|NCT01680016|O2|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
123580|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
123581|NCT01680016|E4|Reported Event|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
123582|NCT01680016|E3|Reported Event|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123583|NCT01680016|E2|Reported Event|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
123584|NCT01680016|E1|Reported Event|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
123585|NCT01679613|B1|Baseline|Overall Study|This was a randomised, open-label trial in healthy male subjects with a 2-way cross-over Pilot part, followed by a 2-way cross-over Main part. Subjects participated either in the Pilot part with 2 treatments (A and B) given in 1 of the 2 treatment sequences (A_B and B_A) or in the Main part with also 2 treatments (C and D) given in 1 of the 2 treatment sequences (C_D and D_C). Nintedanib administrations of the 2 respective treatments (A and B or C and D) were to be separated by a wash-out period of at least 14 days. The Pilot part was separated from the Main part by at least 3 weeks to allow for interim analysis
123586|NCT01679613|P4|Participant Flow|Nintedanib+Ketoconazole (Main Part)/ Nintedanib (Main Part)|Ketoconazole 400mg was given once daily for 3 days followed by administration of nintedanib 50mg as a single dose 1h after administration of ketoconazole, based on the results from the Pilot part. Nintedanib administration was done under steady state ketoconazole (Treatment D). Following a wash out period of at least 14 days, nintedanib 50mg was given as a single dose, based on the results from the Pilot part (Treatment C).
123587|NCT01679613|P3|Participant Flow|Nintedanib (Main Part)/ Nintedanib+Ketoconazole (Main Part)|Based on the results from the Pilot part, nintedanib 50mg was given as a single dose (Treatment C). Following a wash out period of at least 14 days, ketoconazole 400mg was given once daily for 3 days followed by administration of nintedanib 50mg as a single dose 1h after administration of ketoconazole, based on the results from the Pilot part. Nintedanib administration was done under steady state ketoconazole (Treatment D)
123588|NCT01679613|P2|Participant Flow|Nintedanib+Ketoconazole (Pilot Part)/ Nintedanib (Pilot Part)|Ketoconazole 400mg was given once daily for three days and nintedanib 50 mg was given as a single dose 1 hour (h) after the ketoconazole administration with ketoconazole under steady-state conditions (Treatment B). Following a wash out period of at least 14 days, nintedanib 50mg was given as a single dose (Treatment A).
123589|NCT01679613|P1|Participant Flow|Nintedanib (Pilot Part)/ Nintedanib+Ketoconazole (Pilot Part)|Nintedanib 50mg was given as a single dose (Treatment A). Following a wash out period of at least 14 days, ketoconazole 400mg was given once daily for three days and nintedanib 50 mg was given as a single dose 1 hour (h) after the ketoconazole administration with ketoconazole under steady-state conditions (Treatment B)
123590|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.
In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
123591|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.
In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
123592|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.
In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
123593|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.
In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
123594|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.
In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
123595|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.
In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
123596|NCT01679613|E3|Reported Event|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.
In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
123597|NCT01679613|E2|Reported Event|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.
In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
123601|NCT01679600|B1|Baseline|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise
Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
123602|NCT01679600|P2|Participant Flow|RATE|"Robotics-assisted treadmill exercise
Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
123603|NCT01679600|P1|Participant Flow|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise
Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
123604|NCT01679600|O2|Outcome|RATE|"Robotics-assisted treadmill exercise
Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
123605|NCT01679600|O1|Outcome|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise
Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
123606|NCT01679600|E2|Reported Event|RATE|"Robotics-assisted treadmill exercise
Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
123607|NCT01679600|E1|Reported Event|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise
Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
123608|NCT01679314|B3|Baseline|Total|Total of all reporting groups
123609|NCT01679314|B2|Baseline|Sham AlphaCore Device|"AlphaCore sham device
AlphaCore device: Each study group will go under the same treatment regimen and assessments."
123610|NCT01679314|B1|Baseline|Active AlphaCore Device|"AlphaCore active stimulation treatment
AlphaCore device: Each study group will go under the same treatment regimen and assessments."
123611|NCT01679314|P2|Participant Flow|Sham AlphaCore Device|"AlphaCore sham device
AlphaCore device: Each study group will go under the same treatment regimen and assessments."
123612|NCT01679314|P1|Participant Flow|Active AlphaCore Device|"AlphaCore active stimulation treatment
AlphaCore device: Each study group will go under the same treatment regimen and assessments."
123613|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
123614|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
123615|NCT01679314|O2|Outcome|Sham AlphaCore Device|"Sham AlphaCore Device
Each study group will go under the same treatment regimen and assessments."
123616|NCT01679314|O1|Outcome|Active AlphaCore Device|"Active AlphaCore Device
Each study group will go under the same treatment regimen and assessments."
123617|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
123618|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
123619|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
123620|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
123621|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
123622|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
123623|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
123624|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
123625|NCT01679314|O2|Outcome|Sham AlphaCore Device|"AlphaCore sham device
AlphaCore device: Each study group will go under the same treatment regimen and assessments."
123626|NCT01679314|O1|Outcome|Active AlphaCore Device|"AlphaCore active stimulation treatment
AlphaCore device: Each study group will go under the same treatment regimen and assessments."
123627|NCT01679314|E2|Reported Event|Sham AlphaCore Device|"AlphaCore sham device
AlphaCore device: Each study group will go under the same treatment regimen and assessments."
123628|NCT01679314|E1|Reported Event|Active AlphaCore Device|"AlphaCore active stimulation treatment
AlphaCore device: Each study group will go under the same treatment regimen and assessments."
123629|NCT01679236|B3|Baseline|Total|Total of all reporting groups
123630|NCT01679236|B2|Baseline|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.
Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
123631|NCT01679236|B1|Baseline|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.
Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
123678|NCT01679002|B2|Baseline|Group B|BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 450 mg od
123679|NCT01679002|B1|Baseline|Group A|BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid
123680|NCT01679002|P3|Participant Flow|Group C|oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid
123632|NCT01679236|P2|Participant Flow|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.
Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
123633|NCT01679236|P1|Participant Flow|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.
Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
123634|NCT01679236|O2|Outcome|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.
Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
123635|NCT01679236|O1|Outcome|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.
Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
123636|NCT01679236|E2|Reported Event|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.
Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
123637|NCT01679236|E1|Reported Event|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.
Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
123638|NCT01679197|B1|Baseline|Treatment|"Metreleptin
Metreleptin"
123639|NCT01679197|P1|Participant Flow|Treatment|"Metreleptin
Metreleptin"
123640|NCT01679197|O1|Outcome|Treatment|"Metreleptin
Metreleptin"
123641|NCT01679197|O1|Outcome|Treatment|"Metreleptin
Metreleptin"
123642|NCT01679197|O4|Outcome|LDL mg/dL|Lipid measurement
123643|NCT01679197|O3|Outcome|HDL Cholesterol mg/dL|Lipid measurement
123644|NCT01679197|O2|Outcome|Triglycerides mg/dL|Lipid measurement
123645|NCT01679197|O1|Outcome|Cholesterol, Total mg/dL|Lipid measurement
123646|NCT01679197|O2|Outcome|Liver Function ALT|
123647|NCT01679197|O1|Outcome|Liver Function AST|
123648|NCT01679197|O1|Outcome|Treatment|"Metreleptin
Metreleptin"
123658|NCT01679028|P6|Participant Flow|T89 Group C|T89 225mg bid for 14 days
123659|NCT01679028|P5|Participant Flow|Placebo Group C|Placebo 225mg bid for 14 days
123660|NCT01679028|P4|Participant Flow|T89 Group B|T89 300mg single dose
123661|NCT01679028|P3|Participant Flow|Placebo Group B|Placebo 300mg single dose
123662|NCT01679028|P2|Participant Flow|T89 Group A|T89 150mg single dose
123663|NCT01679028|P1|Participant Flow|Placebo Group A|Placebo 150mg single dose
123664|NCT01679028|O6|Outcome|T89 Group C|T89 225mg bid for 10 days
123665|NCT01679028|O5|Outcome|Placebo Group C|225mg bid for 10 days
123666|NCT01679028|O4|Outcome|T89 Group B|300mg T89; single dose
123667|NCT01679028|O3|Outcome|Placebo Group B|300mg Placebo; single dose
123668|NCT01679028|O2|Outcome|T89 Group A|150mg T89; Single dose
123669|NCT01679028|O1|Outcome|Placebo Group A|150 mg placebo; single dose
123670|NCT01679028|E6|Reported Event|T89 Group C|T89 225mf bid for 14 days
123671|NCT01679028|E5|Reported Event|Placebo Group C|Placebo 225mg bid for 14 days
123672|NCT01679028|E4|Reported Event|T89 Group B|300mg T89 single dose
123673|NCT01679028|E3|Reported Event|Placebo Group B|300mg Placebo single dose
123674|NCT01679028|E2|Reported Event|T89 Group A|150mg T89 single dose
123675|NCT01679028|E1|Reported Event|Placebo Group A|150 mg Placebo Single dose
123676|NCT01679002|B4|Baseline|Total|Total of all reporting groups
123677|NCT01679002|B3|Baseline|Group C|oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 450 mg od - BIA 2-093 450 mg bid
123681|NCT01679002|P2|Participant Flow|Group B|"BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period
BIA 2-093 450 mg bid OXC 450 mg bid BIA 2-093 900 mg od"
123682|NCT01679002|P1|Participant Flow|Group A|"BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period.
BIA 2-093 900 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid"
123683|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
123684|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
123685|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
123686|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
123687|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
123688|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
123689|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
123690|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
123691|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
123692|NCT01679002|E3|Reported Event|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
123693|NCT01679002|E2|Reported Event|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
123694|NCT01679002|E1|Reported Event|BIA 2-093 900 mg|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
123695|NCT01678976|B3|Baseline|Total|Total of all reporting groups
123696|NCT01678976|B2|Baseline|Period 1 - Oxcarbazepine; Period 2 - BIA 2-093|Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
123697|NCT01678976|B1|Baseline|Period 1 - BIA 2-093; Period 2 - Oxcarbazepine|Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
123698|NCT01678976|P2|Participant Flow|Period 1 - Oxcarbazepine; Period 2 - BIA 2-093|Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
123699|NCT01678976|P1|Participant Flow|Period 1 - BIA 2-093; Period 2 - Oxcarbazepine|Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
123700|NCT01678976|O2|Outcome|Oxcarbazepine|Oxcarbazepine, Trileptal
123701|NCT01678976|O1|Outcome|BIA 2-093|BIA 2-093, ESL, Eslicarbazepine
123702|NCT01678976|O2|Outcome|Oxcarbazepine 900 mg od|Oxcarbazepine, Trileptal®
123703|NCT01678976|O1|Outcome|BIA 2-093 900 mg od|BIA 2-093, ESL, Eslicarbazepine acetate
123704|NCT01678976|O2|Outcome|Oxcarbazepine 900 mg od|Oxcarbazepine, Trileptal®
123705|NCT01678976|O1|Outcome|BIA 2-093 900 mg od|BIA 2-093, ESL Eslicarbazepine acetate
123706|NCT01678976|E2|Reported Event|Oxcarbazepine|Oxcarbazepine, Trileptal
123707|NCT01678976|E1|Reported Event|BIA 2-093|BIA 2-093, ESL, Eslicarbazepine
123708|NCT01678911|B1|Baseline|All Subjects|All randomized subjects
123709|NCT01678911|P2|Participant Flow|Gralise Then Placebo|"Gralise (a long acting gabapentinoid)
Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of “wash-out” before repeating the above procedure for the other arm of the study (placebo or medication)."
123710|NCT01678911|P1|Participant Flow|Placebo, Then Gralise|Subjects may receive a pill with no medicine.
123711|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
123712|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
123713|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
123714|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
123715|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
123716|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
123717|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
123718|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
123719|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
123720|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
123721|NCT01678911|E2|Reported Event|Gralise|"Gralise (a long acting gabapentinoid)
Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of “wash-out” before repeating the above procedure for the other arm of the study (placebo or medication)."
123722|NCT01678911|E1|Reported Event|Sugar Pill|Subjects may receive a pill with no medicine.
123723|NCT01678885|B3|Baseline|Total|Total of all reporting groups
123762|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
136558|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
123724|NCT01678885|B2|Baseline|Sub-study 2|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
123725|NCT01678885|B1|Baseline|Sub-study 1|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
123726|NCT01678885|P5|Participant Flow|Phase 2- Low-Calorie Diet|"Participants from sub-study 1 and 2 had the chance to receive the low-calorie diet based on their eligibility; i.e., BMI level.
Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected."
123727|NCT01678885|P4|Participant Flow|Phase I Sub Study 2 - Sensewear First, Then Digital Photo|Phase 1- sensewear First, Then Digital Photography
123728|NCT01678885|P3|Participant Flow|Phase 1 Sub Study 2 - Dig Photo First, Then Sensewear|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
123729|NCT01678885|P2|Participant Flow|Phase 1 Sub-study 1 - IDEEA & Actical First, Then Dig Photo|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
123730|NCT01678885|P1|Participant Flow|Phase I Sub-study 1 - Dig Photo First, Then IDEEA & Actical|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
123731|NCT01678885|O1|Outcome|All Participants|All study participants were included in these analyses
123835|NCT01678196|B2|Baseline|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
123732|NCT01678885|O1|Outcome|All Participants|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
123733|NCT01678885|O1|Outcome|Phase II|Participants who complete Phase I of the study received a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan was a 1000-1150 kcal/day diet composed of Health One shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data was collected.
123734|NCT01678885|O1|Outcome|Phase 1|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods (RFPM). During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.
123841|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
123735|NCT01678885|E2|Reported Event|Sub-study 2|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
123736|NCT01678885|E1|Reported Event|Sub-study 1|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
123737|NCT01678846|B3|Baseline|Total|Total of all reporting groups
123738|NCT01678846|B2|Baseline|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
123739|NCT01678846|B1|Baseline|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
123740|NCT01678846|P2|Participant Flow|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
123741|NCT01678846|P1|Participant Flow|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
123742|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
123743|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
123744|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
123759|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123745|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
123746|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
123763|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123842|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
123747|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
123748|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
123749|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
123750|NCT01678846|E2|Reported Event|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
123751|NCT01678846|E1|Reported Event|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
123752|NCT01678820|B4|Baseline|Total|Total of all reporting groups
123753|NCT01678820|B3|Baseline|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123754|NCT01678820|B2|Baseline|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123755|NCT01678820|B1|Baseline|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123756|NCT01678820|P3|Participant Flow|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123757|NCT01678820|P2|Participant Flow|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123758|NCT01678820|P1|Participant Flow|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123830|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
123831|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
123760|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123761|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123968|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.
123764|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123765|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123766|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123767|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123768|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123769|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123770|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123771|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123772|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123773|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123774|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123775|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123832|NCT01678313|E2|Reported Event|Control Group|Doxazosin 4 mg every day (QD)
123833|NCT01678313|E1|Reported Event|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
123776|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123777|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123778|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123779|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123780|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123781|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123782|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123783|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123784|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123785|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123786|NCT01678820|O2|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123787|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123788|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123789|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123790|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123791|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123834|NCT01678196|B3|Baseline|Total|Total of all reporting groups
124070|NCT01677182|E1|Reported Event|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
123792|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123793|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123794|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123795|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123796|NCT01678820|E3|Reported Event|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123797|NCT01678820|E2|Reported Event|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123798|NCT01678820|E1|Reported Event|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
123799|NCT01678807|B4|Baseline|Total|Total of all reporting groups
123800|NCT01678807|B3|Baseline|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
123801|NCT01678807|B2|Baseline|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
123802|NCT01678807|B1|Baseline|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
123803|NCT01678807|P3|Participant Flow|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
123804|NCT01678807|P2|Participant Flow|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
123805|NCT01678807|P1|Participant Flow|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
123806|NCT01678807|O3|Outcome|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
123807|NCT01678807|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
123808|NCT01678807|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
123809|NCT01678807|O3|Outcome|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
123810|NCT01678807|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
123811|NCT01678807|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
123812|NCT01678807|E3|Reported Event|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
123813|NCT01678807|E2|Reported Event|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
123814|NCT01678807|E1|Reported Event|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
123815|NCT01678313|B3|Baseline|Total|Total of all reporting groups
123816|NCT01678313|B2|Baseline|Control Group|Doxazosin 4 mg alone everyday, complete 3 month therapy N=58(82.9%)
123817|NCT01678313|B1|Baseline|Study Group|Doxazosin 4 mg daily plus celecoxib 200 mg daily, complete 3 month therapy N=64(91.4%)
123818|NCT01678313|P2|Participant Flow|Control Group|Doxazosin 4 mg every day (QD)
123819|NCT01678313|P1|Participant Flow|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
123820|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
123821|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
123822|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
123823|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
123824|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
123825|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
123826|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
123827|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
123828|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
123829|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
123836|NCT01678196|B1|Baseline|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
123837|NCT01678196|P2|Participant Flow|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
123838|NCT01678196|P1|Participant Flow|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
123839|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
123840|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
124017|NCT01677286|O1|Outcome|Amyloid Nephropathy|Patients with predominant amyloid kidney involvement at enrollment.
123843|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
123844|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
123845|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
123846|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
123847|NCT01678196|E2|Reported Event|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
123848|NCT01678196|E1|Reported Event|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
123849|NCT01678131|B4|Baseline|Total|Total of all reporting groups
123850|NCT01678131|B3|Baseline|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
123851|NCT01678131|B2|Baseline|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
123852|NCT01678131|B1|Baseline|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
123853|NCT01678131|P3|Participant Flow|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
123854|NCT01678131|P2|Participant Flow|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
123855|NCT01678131|P1|Participant Flow|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
123856|NCT01678131|O3|Outcome|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
123857|NCT01678131|O2|Outcome|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
123858|NCT01678131|O1|Outcome|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
123859|NCT01678131|E3|Reported Event|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
123860|NCT01678131|E2|Reported Event|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
123861|NCT01678131|E1|Reported Event|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
123862|NCT01677988|B1|Baseline|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
123863|NCT01677988|P1|Participant Flow|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
123864|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
123865|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
123866|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
123867|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
123868|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
124018|NCT01677286|O1|Outcome|Cardiomyopathy|Patients with predominant amyloid involvement of the heart.
123869|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
123870|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
123871|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for -08 weeks, then surgical resection
123872|NCT01677988|E1|Reported Event|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
123873|NCT01677936|B3|Baseline|Total|Total of all reporting groups
123874|NCT01677936|B2|Baseline|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.
Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
123875|NCT01677936|B1|Baseline|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.
Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
123876|NCT01677936|P2|Participant Flow|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.
Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
123877|NCT01677936|P1|Participant Flow|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.
Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
123878|NCT01677936|O2|Outcome|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.
Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
123879|NCT01677936|O1|Outcome|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.
Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
123880|NCT01677936|O2|Outcome|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.
Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
123881|NCT01677936|O1|Outcome|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.
Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
123882|NCT01677936|E2|Reported Event|Snacks|Snack group
123883|NCT01677936|E1|Reported Event|Raisin|Raisin group
123884|NCT01677858|B6|Baseline|Total|Total of all reporting groups
123885|NCT01677858|B5|Baseline|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123911|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123912|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
123886|NCT01677858|B4|Baseline|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123887|NCT01677858|B3|Baseline|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123888|NCT01677858|B2|Baseline|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123889|NCT01677858|B1|Baseline|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123969|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
124019|NCT01677286|O1|Outcome|Cardiomyopathy|Patients with predominant amyloid involvement of the heart.
123890|NCT01677858|P5|Participant Flow|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123891|NCT01677858|P4|Participant Flow|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123892|NCT01677858|P3|Participant Flow|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123893|NCT01677858|P2|Participant Flow|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123894|NCT01677858|P1|Participant Flow|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123895|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123896|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123897|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
123898|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123899|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123900|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
123901|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123902|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123903|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
123904|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123905|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123906|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
123907|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123908|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123909|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
123910|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
124071|NCT01676896|B4|Baseline|Total|Total of all reporting groups
123913|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123914|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123915|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
123916|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123917|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123918|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
123919|NCT01677858|O3|Outcome|Carfilzomib 88 mg/m²|Participants in phase 1 received carfilzomib 88 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123920|NCT01677858|O2|Outcome|Carfilzomib 70 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 70 mg/m² administered by intravenous (IV) infusion from day 8 cycle 1 onwards.
123921|NCT01677858|O1|Outcome|Carfilzomib 20 mg/m²|Participants in phase 1 and phase 2 received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on day 1 cycle 1.
124015|NCT01677286|P1|Participant Flow|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.
123922|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123923|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123924|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123925|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123926|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123927|NCT01677858|O6|Outcome|Phase 1+2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123928|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123929|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123930|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123931|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123932|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123933|NCT01677858|O6|Outcome|Phase 1+2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123934|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123935|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123936|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123970|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
124016|NCT01677286|O1|Outcome|Amyloid Nephropathy: Proteinuria (g/Day)|Patients with predominant amyloid kidney involvement at enrollment.
123937|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123938|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123939|NCT01677858|O6|Outcome|Phase 1+2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123940|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123941|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123942|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123943|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123944|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123945|NCT01677858|O6|Outcome|Phase 1+2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123946|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123947|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123948|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123994|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID
EFB0027: Comparison of enteric-coating to assess effect on PK
EFB0026: Active comparator"
123995|NCT01677299|O3|Outcome|500 mg EFB0027|"BID
EFB0027: Comparison of enteric-coating to assess effect on PK"
126934|NCT01665170|O1|Outcome|Placebo|Placebo arm
123949|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123950|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123951|NCT01677858|O6|Outcome|Phase 1+2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123952|NCT01677858|O5|Outcome|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123953|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123954|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123955|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123956|NCT01677858|O1|Outcome|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123957|NCT01677858|O4|Outcome|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123958|NCT01677858|O3|Outcome|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123959|NCT01677858|O2|Outcome|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123960|NCT01677858|O1|Outcome|Phase 1 Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123961|NCT01677858|E5|Reported Event|Phase 2: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123962|NCT01677858|E4|Reported Event|Phase 1: Carfilzomib 88 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123963|NCT01677858|E3|Reported Event|Phase 1: Carfilzomib 70 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123996|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID
EFB0027: Comparison of enteric-coating to assess effect on PK"
123997|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID
EFB0026: Active comparator"
126935|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
123964|NCT01677858|E2|Reported Event|Phase 1: Carfilzomib 56 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123965|NCT01677858|E1|Reported Event|Phase 1: Carfilzomib 45 mg/m²|Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
123966|NCT01677767|B1|Baseline|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
123967|NCT01677767|P1|Participant Flow|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
123971|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
123972|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
123973|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
123974|NCT01677767|O1|Outcome|C.E.R.A.|Participants with Hb less than (<) 10 g/dL at enrollment were evaluated for correction of anemia.
123975|NCT01677767|O1|Outcome|C.E.R.A.|Participants with Hb less than (<) 10 g/dL at enrollment were evaluated for correction of anemia.
123976|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
123977|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
123978|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
123979|NCT01677767|E1|Reported Event|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
123980|NCT01677624|B1|Baseline|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
123981|NCT01677624|P1|Participant Flow|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
123982|NCT01677624|O1|Outcome|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
123983|NCT01677624|O1|Outcome|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
123984|NCT01677624|E1|Reported Event|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
123985|NCT01677299|B5|Baseline|Total|Total of all reporting groups
123986|NCT01677299|B4|Baseline|Sequence DACB|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
123987|NCT01677299|B3|Baseline|Sequence CDBA|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
123988|NCT01677299|B2|Baseline|Sequence ABDC|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
123989|NCT01677299|B1|Baseline|Sequence BCAD|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
123990|NCT01677299|P4|Participant Flow|Sequence 4: DACB|"BID
Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
123991|NCT01677299|P3|Participant Flow|Sequence 3: CDBA|"BID
Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
123992|NCT01677299|P2|Participant Flow|Sequence 2: ABDC|"BID
Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
123993|NCT01677299|P1|Participant Flow|Sequence 1: BCAD|"BID
Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
124069|NCT01677182|E2|Reported Event|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
123998|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID
EFB0027: Comparison of enteric-coating to assess effect on PK
EFB0026: Active comparator"
123999|NCT01677299|O3|Outcome|500 mg EFB0027|"BID
EFB0027: Comparison of enteric-coating to assess effect on PK"
124000|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID
EFB0027: Comparison of enteric-coating to assess effect on PK"
124001|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID
EFB0026: Active comparator"
124002|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID
EFB0027: Comparison of enteric-coating to assess effect on PK
EFB0026: Active comparator"
124003|NCT01677299|O3|Outcome|500 mg EFB0027|"BID
EFB0027: Comparison of enteric-coating to assess effect on PK"
124004|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID
EFB0027: Comparison of enteric-coating to assess effect on PK"
124005|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID
EFB0026: Active comparator"
124006|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|BID
124007|NCT01677299|O3|Outcome|500 mg EFB0027|BID
124008|NCT01677299|O2|Outcome|1000 mg EFB0027|BID
124009|NCT01677299|O1|Outcome|1000 mg EFB0026|BID
124010|NCT01677299|E4|Reported Event|500 mg EFB0026 BID Plus 1000 mg EFB0027 BID|D: Metformin immediate plus Metformin delayed release
124011|NCT01677299|E3|Reported Event|500 mg EFB0027 BID|C: Metformin delayed release BID
124012|NCT01677299|E2|Reported Event|1000 mg EFB0027 BID|B: Metformin delayed release BID
124013|NCT01677299|E1|Reported Event|1000 mg EFB0026 BID|A: Metformin immediate release BID
124014|NCT01677286|B1|Baseline|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.
136559|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
124020|NCT01677286|E1|Reported Event|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth was administered to subjects for 12 months, if tolerated.
124021|NCT01677195|B4|Baseline|Total|Total of all reporting groups
124022|NCT01677195|B3|Baseline|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.
Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
124023|NCT01677195|B2|Baseline|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.
ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
124024|NCT01677195|B1|Baseline|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.
ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
124025|NCT01677195|P3|Participant Flow|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.
Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
124026|NCT01677195|P2|Participant Flow|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.
ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
124027|NCT01677195|P1|Participant Flow|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.
ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
124028|NCT01677195|O3|Outcome|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.
Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
124029|NCT01677195|O2|Outcome|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.
ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
124030|NCT01677195|O1|Outcome|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.
ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
124031|NCT01677195|E3|Reported Event|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.
Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
124032|NCT01677195|E2|Reported Event|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.
ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
124033|NCT01677195|E1|Reported Event|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.
ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
124034|NCT01677182|B4|Baseline|Total|Total of all reporting groups
124035|NCT01677182|B3|Baseline|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
124036|NCT01677182|B2|Baseline|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
124037|NCT01677182|B1|Baseline|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
124038|NCT01677182|P3|Participant Flow|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
124039|NCT01677182|P2|Participant Flow|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
124040|NCT01677182|P1|Participant Flow|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
124041|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
124042|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
124043|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
124044|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
124045|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
124046|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
124047|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
124048|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
124049|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
124050|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
124051|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
124052|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
124053|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
124054|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
124055|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
124056|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
124057|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
124058|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
124059|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
124060|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
124061|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
124062|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
124063|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
124064|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
124065|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
124066|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
124067|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
124068|NCT01677182|E3|Reported Event|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
126936|NCT01665170|O1|Outcome|Placebo|Placebo arm
124072|NCT01676896|B3|Baseline|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124073|NCT01676896|B2|Baseline|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124074|NCT01676896|B1|Baseline|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124075|NCT01676896|P3|Participant Flow|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124214|NCT01676298|P5|Participant Flow|*1/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124215|NCT01676298|P4|Participant Flow|*3/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124076|NCT01676896|P2|Participant Flow|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124077|NCT01676896|P1|Participant Flow|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124078|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124079|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124080|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124081|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124082|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124105|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124185|NCT01676532|O1|Outcome|Students Attending SBHC|Students who were enrolled at the SBHC and then attended the SBHC
126937|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
124083|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124084|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124085|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124132|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124086|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124087|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124088|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124089|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124090|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124091|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124092|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124093|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124117|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
126938|NCT01665170|O1|Outcome|Placebo|Placebo arm
124094|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124095|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124096|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124097|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124098|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124099|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124100|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124101|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124102|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124103|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124104|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124186|NCT01676532|E1|Reported Event|Students Attending SBHC|Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
124187|NCT01676415|B3|Baseline|Total|Total of all reporting groups
124106|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124107|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124108|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124109|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124110|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124111|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124112|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124113|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124114|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124115|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124116|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124251|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
126939|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
124118|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124119|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124120|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124121|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124122|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124123|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124124|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124125|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124126|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124127|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124128|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124252|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
126940|NCT01665170|O1|Outcome|Placebo|Placebo arm
124129|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124130|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124131|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124133|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124134|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124135|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124136|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124137|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124138|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124139|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124151|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124140|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124141|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124142|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124210|NCT01676298|B1|Baseline|*1/*1 CYP2C19 Genotype|
124211|NCT01676298|P8|Participant Flow|*2/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124212|NCT01676298|P7|Participant Flow|*2/*3 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124143|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124144|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124145|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124146|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124147|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124148|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124149|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124150|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124180|NCT01676532|O1|Outcome|Sprucecourt Public School Vs Other Participating Schools|The number of students from the host school of the SBHC and other participating schools
124181|NCT01676532|O1|Outcome|Number of Students From Sprucecourt Who Enrolled in SBHC|From the total number of students who enrolled in the SBHC, the number of students from the host school (Sprucecourt) was calculated
126941|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
124152|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124153|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124154|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124155|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124156|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124157|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124158|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124159|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124160|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124161|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124162|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124182|NCT01676532|O1|Outcome|Number of Referrals Made for Students Attending SBHC|Types and number of referrals made for students attending SBHC.
124183|NCT01676532|O1|Outcome|Number of Students Attending SBHC With New Diagnoses|Porportion of students attending SBHC with new diagnoses
124184|NCT01676532|O1|Outcome|Number of Students Attending SBHC With New Treatment Plans|The total number of students who attended SBHC that had new treatment plans proposed
124163|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124164|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124165|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124166|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124167|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124168|NCT01676896|E3|Reported Event|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
Health Promotion in-school class"
124169|NCT01676896|E2|Reported Event|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Asthma Day Camp"
124170|NCT01676896|E1|Reported Event|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Asthma in-school class"
124171|NCT01676714|B1|Baseline|Dovitinib|"500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
Dovitinib"
124172|NCT01676714|P1|Participant Flow|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
124173|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
124174|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
124175|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
124176|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days.
124177|NCT01676714|E1|Reported Event|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
124178|NCT01676532|B1|Baseline|Students Attending SBHC|"Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
Students attending SBHC: School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC"
124179|NCT01676532|P1|Participant Flow|Students Attending SBHC|Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
124188|NCT01676415|B2|Baseline|Topical Mometasone|"Topical steroid medication
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
124189|NCT01676415|B1|Baseline|Prednisone|"Oral steroid medication
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
124190|NCT01676415|P2|Participant Flow|Topical Mometasone|"Topical steroid medication
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
124213|NCT01676298|P6|Participant Flow|*17/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124191|NCT01676415|P1|Participant Flow|Prednisone|"Oral steroid medication
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
124192|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
124193|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
124194|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
124195|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
124196|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
124197|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
124198|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
124199|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
124253|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
126942|NCT01665170|O1|Outcome|Placebo|Placebo arm
124200|NCT01676415|E2|Reported Event|Topical Mometasone|"Topical steroid medication
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
124201|NCT01676415|E1|Reported Event|Prednisone|"Oral steroid medication
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
124202|NCT01676298|B9|Baseline|Total|Total of all reporting groups
124203|NCT01676298|B8|Baseline|*2/*17 CYP2C19 Genotype|
124204|NCT01676298|B7|Baseline|*2/*3 CYP2C19 Genotype|
124205|NCT01676298|B6|Baseline|*17/*17 CYP2C19 Genotype|
124206|NCT01676298|B5|Baseline|*1/*17 CYP2C19 Genotype|
124207|NCT01676298|B4|Baseline|*3/*1 CYP2C19 Genotype|
124208|NCT01676298|B3|Baseline|*2/*2 CYP2C19 Genotype|
124209|NCT01676298|B2|Baseline|*1/*2 CYP2C19 Genotype|
124216|NCT01676298|P3|Participant Flow|*2/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124217|NCT01676298|P2|Participant Flow|*1/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124218|NCT01676298|P1|Participant Flow|*1/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124219|NCT01676298|O8|Outcome|*2/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124220|NCT01676298|O7|Outcome|*2/*3 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124221|NCT01676298|O6|Outcome|*17/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124222|NCT01676298|O5|Outcome|*1/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124223|NCT01676298|O4|Outcome|*3/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124224|NCT01676298|O3|Outcome|*2/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124225|NCT01676298|O2|Outcome|*1/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124226|NCT01676298|O1|Outcome|*1/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
124227|NCT01676298|E8|Reported Event|*2/*17 CYP2C19 Genotype|
124228|NCT01676298|E7|Reported Event|*2/*3 CYP2C19 Genotype|
124229|NCT01676298|E6|Reported Event|*17/*17 CYP2C19 Genotype|
124230|NCT01676298|E5|Reported Event|*1/*17 CYP2C19 Genotype|
124231|NCT01676298|E4|Reported Event|*3/*1 CYP2C19 Genotype|
124232|NCT01676298|E3|Reported Event|*2/*2 CYP2C19 Genotype|
124233|NCT01676298|E2|Reported Event|*1/*2 CYP2C19 Genotype|
124234|NCT01676298|E1|Reported Event|*1/*1 CYP2C19 Genotype|
124235|NCT01676220|B3|Baseline|Total|Total of all reporting groups
124236|NCT01676220|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124237|NCT01676220|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124238|NCT01676220|P2|Participant Flow|Lantus (Insulin Glargine)|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
124239|NCT01676220|P1|Participant Flow|HOE901-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
124240|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124241|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124242|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124243|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124244|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124245|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124246|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124247|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124248|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
124249|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
124250|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124254|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124255|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124256|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124257|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124258|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124259|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124260|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124261|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124262|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124263|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124264|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124265|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
124266|NCT01676220|E2|Reported Event|Lantus|Lantus SC injection once daily for 12 months in combination with non­insulin antihyperglycemic drug(s).
124267|NCT01676220|E1|Reported Event|HOE901-U300|HOE901­U300 SC injection once daily for 12 months in combination with non­insulin antihyperglycemic drug(s).
124268|NCT01676012|B1|Baseline|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.
Standard white light videobronchoscopy (WLB)
High Definition -Bronchoscopy
HD-bronchoscopy + surface enhancement (iScan-surface)
HD-bronchoscopy + tone enhancement (iScan-tone)
Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
124269|NCT01676012|P1|Participant Flow|Five Types of Bronchoscopy|"Standard white light videobronchoscopy (WLB)
High Definition -Bronchoscopy
HD-bronchoscopy + surface enhancement (iScan-surface)
HD-bronchoscopy + tone enhancement (iScan-tone)
Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
124270|NCT01676012|O1|Outcome|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.
Standard white light videobronchoscopy (WLB)
High Definition -Bronchoscopy
HD-bronchoscopy + surface enhancement (iScan-surface)
HD-bronchoscopy + tone enhancement (iScan-tone)
Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
124271|NCT01676012|E1|Reported Event|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.
Standard white light videobronchoscopy (WLB)
High Definition -Bronchoscopy
HD-bronchoscopy + surface enhancement (iScan-surface)
HD-bronchoscopy + tone enhancement (iScan-tone)
Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
124272|NCT01675830|B1|Baseline|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
124273|NCT01675830|P1|Participant Flow|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
124274|NCT01675830|O1|Outcome|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
124275|NCT01675830|O1|Outcome|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
124276|NCT01675830|E1|Reported Event|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
124277|NCT01675661|B3|Baseline|Total|Total of all reporting groups
124278|NCT01675661|B2|Baseline|Placebo Plus CM|"Placebo plus Contingency Management (CM)
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124279|NCT01675661|B1|Baseline|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124280|NCT01675661|P2|Participant Flow|Placebo Plus CM|"Placebo plus Contingency Management (CM)
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124281|NCT01675661|P1|Participant Flow|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124282|NCT01675661|O4|Outcome|Baseline Non-Smokder Placebo Plus CM|This analysis divided folks by baseline smoking status. This is the group of non-smokers randomized to the matched placebo arm and received placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
124283|NCT01675661|O3|Outcome|Baseline Non-Smoker NAC Plus CM|This analysis divided participants by baseline smoking status. This is the group of non-smokers randomized to the N-Acetylcysteine 1200mg twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
124284|NCT01675661|O2|Outcome|Baseline Smoker Placebo Plus CM|"Placebo plus Contingency Management (CM)
This analysis divided folks by baseline smoking status. Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124316|NCT01675453|E2|Reported Event|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
0.9% NaCl"
124285|NCT01675661|O1|Outcome|Baseline Smoker NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)
This analysis divided those by baseline smoking status. N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124286|NCT01675661|O2|Outcome|Placebo Plus CM|"Placebo plus Contingency Management (CM)
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124287|NCT01675661|O1|Outcome|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124288|NCT01675661|O2|Outcome|Placebo Plus CM|"Placebo plus Contingency Management (CM)
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124289|NCT01675661|O1|Outcome|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124290|NCT01675661|E2|Reported Event|Placebo Plus CM|"Placebo plus Contingency Management (CM)
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124291|NCT01675661|E1|Reported Event|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
124292|NCT01675544|B1|Baseline|Heart Failure Admission|"Patients admitted for acute decompensated heart failure
Electrocardiogram: EKG voltage changes between admission and discharge
Six minute walk test"
124293|NCT01675544|P1|Participant Flow|Heart Failure Admission|"Patients admitted for acute decompensated heart failure
Electrocardiogram: EKG voltage changes between admission and discharge
Six minute walk test"
124294|NCT01675544|O1|Outcome|Heart Failure Admission|"Patients admitted for acute decompensated heart failure
Electrocardiogram: EKG voltage changes between admission and discharge
Six minute walk test"
124295|NCT01675544|O1|Outcome|Heart Failure Admission|"Patients admitted for acute decompensated heart failure
Electrocardiogram: EKG voltage changes between admission and discharge
Six minute walk test"
124296|NCT01675544|E1|Reported Event|Heart Failure Admission|"Patients admitted for acute decompensated heart failure
Electrocardiogram: EKG voltage changes between admission and discharge
Six minute walk test"
124297|NCT01675531|B1|Baseline|Oxycodone/Naloxone|"Targin
Targin: Single arm for Targin"
124298|NCT01675531|P1|Participant Flow|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)
Targin: Single arm for Targin"
124299|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)
Targin: Single arm for Targin"
124300|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)
Targin: Single arm for Targin"
124301|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)
Targin: Single arm for Targin"
124302|NCT01675531|O1|Outcome|Oxycodone/Naloxone|"Targin
Targin: Single arm for Targin"
124303|NCT01675531|E1|Reported Event|Oxycodone/Naloxone|"Targin(Oxycodone/Naloxone)
Targin: Single arm for Targin"
124304|NCT01675492|B1|Baseline|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
124305|NCT01675492|P1|Participant Flow|Wave-front Guided LASIK|Vision correction for a mixed astigmatism refraction
124306|NCT01675492|O1|Outcome|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
124307|NCT01675492|O1|Outcome|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for a mixed astigmatism refraction
124308|NCT01675492|E1|Reported Event|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
124309|NCT01675453|B3|Baseline|Total|Total of all reporting groups
124310|NCT01675453|B2|Baseline|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
0.9% NaCl"
124311|NCT01675453|B1|Baseline|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
124312|NCT01675453|P2|Participant Flow|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
0.9% NaCl"
124313|NCT01675453|P1|Participant Flow|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
124314|NCT01675453|O2|Outcome|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
0.9% NaCl"
124315|NCT01675453|O1|Outcome|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
124317|NCT01675453|E1|Reported Event|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
124318|NCT01675427|B1|Baseline|Participants With CHC|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
124319|NCT01675427|P1|Participant Flow|Participants With Chronic Hepatitis C (CHC)|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
124320|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
124321|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
124322|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
124323|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
124324|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
124325|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
124326|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
124327|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
124328|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
124329|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
124330|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
124331|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
124332|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124333|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124334|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124335|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124336|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124337|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124338|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124339|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124340|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124341|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124342|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124343|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124344|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124345|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124346|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124347|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124348|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124349|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124350|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
124351|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
124352|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
124353|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
124354|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
125066|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
124355|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
124356|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
124357|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
124358|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
124359|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
124360|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
124361|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
124362|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
124363|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
124364|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
124365|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
124366|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
124367|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
124368|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
124849|NCT01674010|E1|Reported Event|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
124369|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
124370|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
124371|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
124372|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
124373|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
124374|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
124375|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
124376|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
124377|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
124378|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
124379|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
124380|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
124381|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
124382|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
124383|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
124384|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
124385|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
124386|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
124387|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
124388|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
124389|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 Alanine-Alanine (AA)|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
124390|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 Alanine-Cysteine (AC)|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
124391|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
124392|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124393|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124394|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124395|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
126943|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
124396|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124397|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124398|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124399|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124400|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124401|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124402|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124403|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124404|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124405|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124406|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124407|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124408|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124409|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124410|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124411|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124412|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124413|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124414|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124415|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124416|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124417|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124418|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124419|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124420|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124421|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124422|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124423|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124424|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124425|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124426|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124427|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124428|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124429|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124430|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124431|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124432|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124433|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124434|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124435|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124436|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124437|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124438|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124439|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124440|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124441|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124442|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124443|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124444|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124445|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124446|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124447|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124448|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124449|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124450|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124451|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124452|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124453|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124454|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124455|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124456|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124457|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124458|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124459|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124460|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124461|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124462|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124463|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124464|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124465|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124466|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124467|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124468|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124469|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124470|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124471|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124472|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124473|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124474|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124475|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124476|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124477|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124478|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124479|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124480|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124481|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124482|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124483|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124484|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124485|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124486|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124487|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124488|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124489|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124490|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124491|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124492|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124493|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124494|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124495|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124496|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124497|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124498|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124499|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124500|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124501|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124502|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124503|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124504|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124505|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124506|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124507|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124508|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124509|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124510|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124511|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124512|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124513|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124514|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124515|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124516|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124517|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124518|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124519|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124520|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124521|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124522|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124523|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124524|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124525|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124526|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124527|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124528|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124529|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124530|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124531|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124532|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124533|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124534|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124535|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124536|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124537|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124538|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124539|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124540|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124541|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124542|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124543|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124544|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124545|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124546|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124547|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124548|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124549|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124550|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124551|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124552|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124553|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124554|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124555|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124556|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124557|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124558|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124559|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124560|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124561|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124562|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124563|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124564|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124565|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124566|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124567|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124568|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124569|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124570|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124571|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124572|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124573|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124574|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124575|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124576|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124577|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124578|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124579|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124580|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124581|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124582|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124583|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124584|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124585|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124586|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124587|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124588|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124589|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124590|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124591|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124592|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124593|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 Glycine-Glycine (GG)|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
124594|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 Threonine-Glycine (TG)|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
124595|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
124596|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
124597|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124598|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124599|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 Threonine-Threonine (TT)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
125118|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
124600|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 Threonine-Cysteine (TC)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
124601|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 Cysteine-Cysteine (CC)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
124602|NCT01675427|E1|Reported Event|Participants With CHC|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
124603|NCT01675167|B3|Baseline|Total|Total of all reporting groups
124604|NCT01675167|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124605|NCT01675167|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124606|NCT01675167|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124607|NCT01675167|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124608|NCT01675167|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
124609|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124610|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124611|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124701|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
124612|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124613|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124614|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124615|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124616|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124617|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124618|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124619|NCT01675167|O1|Outcome|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
124620|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124621|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124622|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124623|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124624|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124625|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
124626|NCT01675167|E3|Reported Event|DB Placebo Film|Placebo buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period
124627|NCT01675167|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period
124628|NCT01675167|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
124629|NCT01675141|B1|Baseline|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
124630|NCT01675141|P1|Participant Flow|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
124631|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
124632|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
124633|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
124634|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
124635|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
124636|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
124637|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
124638|NCT01675141|E1|Reported Event|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
124639|NCT01675128|B4|Baseline|Total|Total of all reporting groups
124772|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
124640|NCT01675128|B3|Baseline|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124641|NCT01675128|B2|Baseline|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
124642|NCT01675128|B1|Baseline|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
124643|NCT01675128|P3|Participant Flow|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124644|NCT01675128|P2|Participant Flow|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
124645|NCT01675128|P1|Participant Flow|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
124646|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124647|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124648|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124649|NCT01675128|O1|Outcome|Phase I Dose Level I & Phase I Dose Level II|"Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
Phase I Dose Level II Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks."
124650|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124651|NCT01675128|O1|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
124652|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124653|NCT01675128|O1|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
124654|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124655|NCT01675128|O1|Outcome|Phase I Dose Level 2|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
124656|NCT01675128|O3|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124657|NCT01675128|O2|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
125063|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
124658|NCT01675128|O1|Outcome|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
124659|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124660|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124661|NCT01675128|O1|Outcome|All Phase I Participants|Irinotecan 160 (and 180) mg/m^2 every other week.
124662|NCT01675128|O1|Outcome|All Phase I Participants|ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
124663|NCT01675128|E3|Reported Event|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
124664|NCT01675128|E2|Reported Event|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
124665|NCT01675128|E1|Reported Event|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
124773|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
124666|NCT01675063|B1|Baseline|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.
Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
124667|NCT01675063|P1|Participant Flow|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.
Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
124668|NCT01675063|O1|Outcome|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.
Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
124669|NCT01675063|E1|Reported Event|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.
Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
124670|NCT01675050|B3|Baseline|Total|Total of all reporting groups
124671|NCT01675050|B2|Baseline|Placebo Then Cyproheptadine|4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine
124672|NCT01675050|B1|Baseline|Cyproheptadine Then Placebo|4 weeks of cyproheptadine with crossover to 4 weeks of placebo.
124673|NCT01675050|P2|Participant Flow|Sugar Pill First, Than Cyproheptadine|4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine
124674|NCT01675050|P1|Participant Flow|Cyproheptadine First, Then Placebo|4 weeks of cyproheptadine with crossover to 4 weeks of placebo.
124675|NCT01675050|O2|Outcome|All Participants Post Placebo|
124676|NCT01675050|O1|Outcome|All Participants Post Cyproheptadine|
124677|NCT01675050|O2|Outcome|All Participants Post Placebo|
124678|NCT01675050|O1|Outcome|All Participants Post Cyproheptadine|
124679|NCT01675050|E2|Reported Event|Placebo|All participants while on Placebo.
124680|NCT01675050|E1|Reported Event|Cyproheptadine|All participants while on Cyproheptadine.
124681|NCT01675011|B3|Baseline|Total|Total of all reporting groups
124682|NCT01675011|B2|Baseline|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
Embosphere®"
124683|NCT01675011|B1|Baseline|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
Embozene® Microspheres"
124684|NCT01675011|P2|Participant Flow|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
Embosphere®"
124685|NCT01675011|P1|Participant Flow|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
Embozene® Microspheres"
124686|NCT01675011|O2|Outcome|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
Embosphere®"
124687|NCT01675011|O1|Outcome|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
Embozene® Microspheres"
124688|NCT01675011|E2|Reported Event|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
Embosphere®"
124689|NCT01675011|E1|Reported Event|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
Embozene® Microspheres"
124690|NCT01674725|B3|Baseline|Total|Total of all reporting groups
124691|NCT01674725|B2|Baseline|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
124692|NCT01674725|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
124693|NCT01674725|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
124694|NCT01674725|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
124695|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
124696|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
124697|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
124698|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
124699|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
124700|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
124702|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
124703|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
124704|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
124705|NCT01674725|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
124706|NCT01674725|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
124707|NCT01674712|B6|Baseline|Total|Total of all reporting groups
124708|NCT01674712|B5|Baseline|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
124709|NCT01674712|B4|Baseline|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
124710|NCT01674712|B3|Baseline|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
124711|NCT01674712|B2|Baseline|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
124712|NCT01674712|B1|Baseline|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
124713|NCT01674712|P5|Participant Flow|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
124714|NCT01674712|P4|Participant Flow|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
124715|NCT01674712|P3|Participant Flow|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
124716|NCT01674712|P2|Participant Flow|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
124717|NCT01674712|P1|Participant Flow|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
124718|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
124719|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
124720|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
124721|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
124722|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
124723|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
124724|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
124725|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
124726|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
124727|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
124728|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
124729|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
124730|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
124731|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
124732|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
124733|NCT01674712|E5|Reported Event|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
124734|NCT01674712|E4|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
124735|NCT01674712|E3|Reported Event|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
124736|NCT01674712|E2|Reported Event|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
124737|NCT01674712|E1|Reported Event|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
124738|NCT01674647|B3|Baseline|Total|Total of all reporting groups
124739|NCT01674647|B2|Baseline|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124740|NCT01674647|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124741|NCT01674647|P2|Participant Flow|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124742|NCT01674647|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124743|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124744|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124797|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily
BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
126944|NCT01665170|O1|Outcome|Placebo|Placebo arm
124745|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124746|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124774|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
124850|NCT01673984|B3|Baseline|Total|Total of all reporting groups
124747|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124748|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124749|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124750|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124751|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124798|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily
BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
124799|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily
BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
124752|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124753|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124754|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124755|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124756|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124757|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124758|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124800|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily
BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
124801|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily
BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
126945|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
124759|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124760|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124761|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124762|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124763|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124764|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124765|NCT01674647|E2|Reported Event|Vitamin K Antagonist|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
124802|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily
BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
124803|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily
BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
126946|NCT01665170|O1|Outcome|Placebo|Placebo arm
124766|NCT01674647|E1|Reported Event|Rivaroxaban (Xarelto; BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
124767|NCT01674634|B1|Baseline|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
124768|NCT01674634|P1|Participant Flow|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
124769|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
124770|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
124771|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
136560|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
124775|NCT01674634|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the PIP joint cord
124776|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX MP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the MP joint cord
124777|NCT01674634|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the proximal interphalangeal (PIP) joint cord
124778|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX MP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the metacarpophalangeal (MP) joint cord
124779|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
124780|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
124781|NCT01674634|E1|Reported Event|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
124782|NCT01674621|B6|Baseline|Total|Total of all reporting groups
124783|NCT01674621|B5|Baseline|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily
BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
124784|NCT01674621|B4|Baseline|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily
BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
124785|NCT01674621|B3|Baseline|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily
BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
124786|NCT01674621|B2|Baseline|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily
BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
124787|NCT01674621|B1|Baseline|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily
BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
124788|NCT01674621|P5|Participant Flow|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily
BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
124789|NCT01674621|P4|Participant Flow|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily
BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
124790|NCT01674621|P3|Participant Flow|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily
BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
124791|NCT01674621|P2|Participant Flow|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily
BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
124792|NCT01674621|P1|Participant Flow|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily
BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
124793|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily
BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
124794|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily
BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
124795|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily
BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
124796|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily
BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
126947|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
124804|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily
BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
124805|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily
BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
124806|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily
BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
124807|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily
BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
124808|NCT01674621|E5|Reported Event|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily
BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
124809|NCT01674621|E4|Reported Event|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily
BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
124810|NCT01674621|E3|Reported Event|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily
BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
124811|NCT01674621|E2|Reported Event|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily
BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
124812|NCT01674621|E1|Reported Event|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily
BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
124813|NCT01674062|B3|Baseline|Total|Total of all reporting groups
124814|NCT01674062|B2|Baseline|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
124815|NCT01674062|B1|Baseline|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124816|NCT01674062|P2|Participant Flow|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
124817|NCT01674062|P1|Participant Flow|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via intravenous (IV) infusion as 2 milligrams per kilogram (mg/kg) once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 milligrams (mg) followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124818|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124819|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124865|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
125064|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
124820|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124821|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124822|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124845|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
124823|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124824|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124825|NCT01674062|O1|Outcome|Pertuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. The treatment regimen was maintained until disease progression, intolerable toxicity, death, and/or transition to dual-agent therapy with trastuzumab.
124826|NCT01674062|O1|Outcome|Pertuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. The treatment regimen was maintained until disease progression, intolerable toxicity, death, and/or transition to dual-agent therapy with trastuzumab.
124827|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124828|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124829|NCT01674062|E2|Reported Event|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
124866|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
125065|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
124830|NCT01674062|E1|Reported Event|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
124831|NCT01674010|B1|Baseline|All Study Participants|
124832|NCT01674010|P3|Participant Flow|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
124833|NCT01674010|P2|Participant Flow|Phase 2 Placebo|Double Blind Randomization (Phase 2)
124834|NCT01674010|P1|Participant Flow|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
124835|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
124836|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
124837|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
124838|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
124839|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
124840|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
124841|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
124842|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
124843|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
124844|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
124851|NCT01673984|B2|Baseline|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
124852|NCT01673984|B1|Baseline|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
124853|NCT01673984|P2|Participant Flow|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
124854|NCT01673984|P1|Participant Flow|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
124855|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
124856|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
124857|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
124858|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
124859|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
124860|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
124861|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
124862|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
124863|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
124864|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
124957|NCT01673620|P2|Participant Flow|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
124867|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
124868|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
124869|NCT01673984|E2|Reported Event|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
124870|NCT01673984|E1|Reported Event|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
124871|NCT01673919|B1|Baseline|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124872|NCT01673919|P1|Participant Flow|Tocilizumab (8 mg/kg)|Eligible participants received tocilizumab (TCZ) 8 milligram/kilogram (mg/kg) intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in France, whichever came first.
124873|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124874|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124875|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124876|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124877|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124878|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124879|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124880|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124881|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124882|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124883|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124884|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124885|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124886|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124887|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124888|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124889|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124890|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124891|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124892|NCT01673919|E1|Reported Event|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
124893|NCT01673867|B3|Baseline|Total|Total of all reporting groups
124894|NCT01673867|B2|Baseline|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124895|NCT01673867|B1|Baseline|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124896|NCT01673867|P2|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124897|NCT01673867|P1|Participant Flow|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124898|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124899|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124900|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124901|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124902|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124938|NCT01673828|E1|Reported Event|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days
Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
124903|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124904|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124905|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124906|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124907|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124908|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124909|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124910|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124911|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124912|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124913|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124914|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
126948|NCT01665170|O1|Outcome|Placebo|Placebo arm
124915|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124916|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124917|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124918|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124919|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124920|NCT01673867|E2|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
124921|NCT01673867|E1|Reported Event|DOCETAXEL|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
136561|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
124922|NCT01673854|B1|Baseline|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
124923|NCT01673854|P1|Participant Flow|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
124924|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
124925|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
124926|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
124927|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
124928|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
125057|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
124929|NCT01673854|E1|Reported Event|Vemurafenib, 960 mg + Ipilimumab,10 mg/kg ab|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
124930|NCT01673828|B3|Baseline|Total|Total of all reporting groups
124931|NCT01673828|B2|Baseline|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days
Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
124932|NCT01673828|B1|Baseline|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days
Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
124933|NCT01673828|P2|Participant Flow|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days
Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
124934|NCT01673828|P1|Participant Flow|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days
Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
124935|NCT01673828|O2|Outcome|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days
Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
124936|NCT01673828|O1|Outcome|Allopregnanolone|"Allopregnanolone injection (intravenous solution) continuous infusion for 5 days
Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
124937|NCT01673828|E2|Reported Event|Placebo|"Placebo injection (intravenous solution) continuous infusion for 5 days
Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium"
124974|NCT01673594|E2|Reported Event|Placebo|"Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
124939|NCT01673802|B1|Baseline|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
124940|NCT01673802|P1|Participant Flow|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
124941|NCT01673802|O1|Outcome|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
124942|NCT01673802|E1|Reported Event|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
124943|NCT01673698|B3|Baseline|Total|Total of all reporting groups
124944|NCT01673698|B2|Baseline|Sham Comparator|"Sham Comparator
Diet counseling
Exercise counseling"
124945|NCT01673698|B1|Baseline|ReShape Duo Balloon|"ReShape Duo Balloon
ReShape Duo balloon
Diet counseling
Exercise counseling"
124946|NCT01673698|P2|Participant Flow|Sham Comparator|"Sham Comparator
Diet counseling
Exercise counseling"
124947|NCT01673698|P1|Participant Flow|ReShape Duo Balloon|"ReShape Duo Balloon
ReShape Duo balloon
Diet counseling
Exercise counseling"
124948|NCT01673698|O1|Outcome|Intent-to-Treat|Intent-to-Treat population
124949|NCT01673698|O1|Outcome|Intent-to-Treat|Intent-to-Treat population
124950|NCT01673698|O2|Outcome|Control|Control group
124951|NCT01673698|O1|Outcome|Treatment|Treatment group
124952|NCT01673698|E2|Reported Event|Control Subjects|Subjects who were randomized to diet and exercise counseling only during weeks 0-24
124953|NCT01673698|E1|Reported Event|Treatment Subjects|Subjects who were randomized and received a balloon during weeks 0-24
124954|NCT01673620|B3|Baseline|Total|Total of all reporting groups
124955|NCT01673620|B2|Baseline|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
124956|NCT01673620|B1|Baseline|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
126949|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
124958|NCT01673620|P1|Participant Flow|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
124959|NCT01673620|O2|Outcome|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
124960|NCT01673620|O1|Outcome|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
124961|NCT01673620|O2|Outcome|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
124962|NCT01673620|O1|Outcome|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
124963|NCT01673620|E2|Reported Event|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
124964|NCT01673620|E1|Reported Event|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
124965|NCT01673594|B3|Baseline|Total|Total of all reporting groups
124966|NCT01673594|B2|Baseline|Placebo|"Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
124967|NCT01673594|B1|Baseline|Naltrexone|"Arm 1: Naltrexone + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
124968|NCT01673594|P2|Participant Flow|Placebo|"Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
124969|NCT01673594|P1|Participant Flow|Naltrexone|"Arm 1: Naltrexone + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
124970|NCT01673594|O2|Outcome|Placebo|"Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
124971|NCT01673594|O1|Outcome|Naltrexone|"Arm 1: Naltrexone + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
124972|NCT01673594|O2|Outcome|Placebo|"Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
124973|NCT01673594|O1|Outcome|Naltrexone|"Arm 1: Naltrexone + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
128526|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
124975|NCT01673594|E1|Reported Event|Naltrexone|"Arm 1: Naltrexone + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
124976|NCT01673568|B3|Baseline|Total|Total of all reporting groups
124977|NCT01673568|B2|Baseline|no Abdominal Binder|no abdominal binder was warn
124978|NCT01673568|B1|Baseline|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.
ETO garments: patients wearing abdominal binder for 7 days postoperatively"
124979|NCT01673568|P2|Participant Flow|no Abdominal Binder|no abdominal binder
124980|NCT01673568|P1|Participant Flow|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.
ETO garments: patients wearing abdominal binder for 7 days postoperatively"
124981|NCT01673568|O2|Outcome|no Abdominal Binder|no abdominal binder
124982|NCT01673568|O1|Outcome|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.
ETO garments: patients wearing abdominal binder for 7 days postoperatively"
124983|NCT01673568|O2|Outcome|no Abdominal Binder|no abdominal binder
124984|NCT01673568|O1|Outcome|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.
ETO garments: patients wearing abdominal binder for 7 days postoperatively"
124985|NCT01673568|E2|Reported Event|no Abdominal Binder|no abdominal binder
124986|NCT01673568|E1|Reported Event|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.
ETO garments: patients wearing abdominal binder for 7 days postoperatively"
124987|NCT01673490|B1|Baseline|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
124988|NCT01673490|P1|Participant Flow|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
124989|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
124990|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
124991|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
124992|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
124993|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
124994|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
124995|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
124996|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
125083|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
124997|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
124998|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
124999|NCT01673490|E1|Reported Event|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
125000|NCT01673425|B1|Baseline|Live Attenuated Influenza Vaccine Study|This study was terminated due to poor enrollment and inconclusive nasal wash samples. No analyses were performed.
125001|NCT01673425|P1|Participant Flow|Experimental: Live Attenuated Influenza Vaccine|Single intervention study; all participants receive LAIV
125002|NCT01673425|O1|Outcome|Experimental: Live Attenuated Influenza Vaccine|Single Intervention Study
125003|NCT01673425|E1|Reported Event|Study Enrollment|Low accrual. Only 4 subjects completed study in 2 month period. Study terminated.
125004|NCT01673347|B1|Baseline|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.
Meniscal Allograft: Meniscal allograft"
125005|NCT01673347|P1|Participant Flow|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.
Meniscal Allograft: Meniscal allograft"
125006|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
125007|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
125008|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
125009|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
125010|NCT01673347|E1|Reported Event|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.
Meniscal Allograft: Meniscal allograft"
125011|NCT01673282|B3|Baseline|Total Title|
125012|NCT01673282|B2|Baseline|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
125013|NCT01673282|B1|Baseline|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
125014|NCT01673282|P2|Participant Flow|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
125015|NCT01673282|P1|Participant Flow|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
125016|NCT01673282|O2|Outcome|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
125058|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125017|NCT01673282|O1|Outcome|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
125018|NCT01673282|E2|Reported Event|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
125019|NCT01673282|E1|Reported Event|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
125020|NCT01673256|B1|Baseline|SJM Confirm ICM Observational Group|SJM Confirm ICM
125021|NCT01673256|P1|Participant Flow|SJM Confirm ICM Observational Group|SJM Confirm ICM
125022|NCT01673256|O1|Outcome|SJM Confirm ICM Observational Group|SJM Confirm ICM
125023|NCT01673256|E1|Reported Event|SJM Confirm ICM Observational Group|SJM Confirm ICM
125024|NCT01673191|B3|Baseline|Total|Total of all reporting groups
125025|NCT01673191|B2|Baseline|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
125026|NCT01673191|B1|Baseline|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
125027|NCT01673191|P2|Participant Flow|Steroid Plus NSAID Eye Drop Combination Therapy|"NSAID eye drop: Acular LS Steriod eye drop: Pred Forte
Steroid plus NSAID eye drop combination therapy"
125084|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125028|NCT01673191|P1|Participant Flow|OZURDEX Intraocular Implant|"OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg
Dexamethasone intravitreal implant"
125029|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
125030|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
125031|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
125032|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
125033|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
125034|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
125035|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
125059|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125060|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125061|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125062|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125036|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
125037|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
125038|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
125039|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
125085|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125040|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
125041|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
125042|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
125043|NCT01673191|E2|Reported Event|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
125044|NCT01673191|E1|Reported Event|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
125045|NCT01673178|B6|Baseline|Total|Total of all reporting groups
125046|NCT01673178|B5|Baseline|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125047|NCT01673178|B4|Baseline|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125048|NCT01673178|B3|Baseline|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125049|NCT01673178|B2|Baseline|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125050|NCT01673178|B1|Baseline|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125051|NCT01673178|P5|Participant Flow|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125052|NCT01673178|P4|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125053|NCT01673178|P3|Participant Flow|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125054|NCT01673178|P2|Participant Flow|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125055|NCT01673178|P1|Participant Flow|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125056|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
126950|NCT01665170|O1|Outcome|Placebo|Placebo arm
125067|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125068|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125069|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125070|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125071|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125072|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125073|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125074|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125075|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125076|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125077|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125078|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125079|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125080|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125081|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125082|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
136562|NCT01627002|O9|Outcome|Part B Placebo|
125086|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125087|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125088|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125089|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125090|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125091|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125092|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125093|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125094|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125095|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125096|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125097|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125098|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125099|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125100|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125101|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125102|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125103|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125104|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125105|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125106|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125107|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125108|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125109|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125110|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125111|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125112|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125113|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125114|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125115|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125116|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125117|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125119|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125120|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125121|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125122|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125123|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125124|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125125|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125126|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125127|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125128|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125129|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125130|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125131|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125132|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125133|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125134|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125135|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125136|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
128527|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
125137|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125138|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125139|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125140|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125141|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125142|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125143|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125144|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125145|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125146|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125147|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125148|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125149|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125150|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125151|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125152|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125153|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125154|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125155|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125156|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125157|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125158|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125159|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125160|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125161|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125162|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125163|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125164|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125165|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125166|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125167|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125168|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
126951|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
125169|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125170|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125171|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125172|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125173|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125174|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125175|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125176|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125177|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125178|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125179|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125180|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125181|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125182|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125183|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125184|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125185|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125186|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125187|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125188|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125189|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125190|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125191|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125192|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125193|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125194|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125195|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125196|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125197|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125198|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125199|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125200|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125201|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125202|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125203|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125204|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125205|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125206|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125207|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125208|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125209|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125210|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125211|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125212|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125213|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125214|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125215|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125216|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125217|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125218|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
126952|NCT01665170|O1|Outcome|Placebo|Placebo arm
125219|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125220|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125221|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125222|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125223|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125224|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125225|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125226|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125227|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125228|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125229|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125230|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125231|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125232|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125233|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125234|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125235|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125236|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125237|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125238|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125239|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125240|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125241|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125242|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125243|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125244|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125245|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125246|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125247|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125248|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125249|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125250|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125251|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125252|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125253|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125254|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125255|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125256|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125257|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125258|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125259|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125260|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125261|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125262|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125263|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125264|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125265|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125266|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125267|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125268|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
126953|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
125269|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125270|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125271|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125272|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125273|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125274|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125275|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125276|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125277|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125278|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125279|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125280|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125281|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125282|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125283|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125284|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125285|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125286|NCT01673178|E5|Reported Event|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125287|NCT01673178|E4|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125288|NCT01673178|E3|Reported Event|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
125289|NCT01673178|E2|Reported Event|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
125290|NCT01673178|E1|Reported Event|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
125291|NCT01673126|B3|Baseline|Total|Total of all reporting groups
125292|NCT01673126|B2|Baseline|Sham tDCS First|Patients received sham tDCS during 20 minutes. Then, washout of 2days. Then andoal tDCS.
125293|NCT01673126|B1|Baseline|Anodal tDCS First|Patients received anodal tDCS during 20 minutes. Then, washout of 2days. Then sham tDCS.
125294|NCT01673126|P2|Participant Flow|Sham tDCS|Sham tDCS during first, then 2 days of washout, then anodal tDCS.
125295|NCT01673126|P1|Participant Flow|Anodal tDCS|Anodal tDCS (on DLPF cortex) first, hen 2 days of washout, then sham tDCS.
125296|NCT01673126|O2|Outcome|Sham tDCS First|"Patients received sham tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).
Then, a washout period (2days). Then anodal tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)."
125297|NCT01673126|O1|Outcome|Anodal tDCS First|"Patients received anodal tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).
Then, a washout period (2days). Then sham tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)."
125298|NCT01673126|E2|Reported Event|Sham tDCS|"Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.
sham tDCS: Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation."
125299|NCT01673126|E1|Reported Event|Anodal tDCS|"Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)
Anodal tDCS: patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)"
125300|NCT01673113|B3|Baseline|Total|Total of all reporting groups
125301|NCT01673113|B2|Baseline|Control|The untreated flank of each subject served as the internal control.
125302|NCT01673113|B1|Baseline|Treatment|Subjects were randomized to have right or left flank treated with Zeltiq CoolSculpting device
125303|NCT01673113|P2|Participant Flow|Control|The untreated flank of each subject served as internal control.
125304|NCT01673113|P1|Participant Flow|Treatment|Subjects were randomized to have either left or right flank treated with cryolipolysis.
125305|NCT01673113|O2|Outcome|Control|The untreated flank of each subject served as the internal control.
125306|NCT01673113|O1|Outcome|Treatment|Subjects were randomized to have right or left flank treated with Zeltiq CoolSculpting device
125307|NCT01673113|O2|Outcome|Control|Untreated flanks of each subject had vibration sensory testing done within 48-72 hours after treatment.
125308|NCT01673113|O1|Outcome|Treatment|Cryolipolysis treated flanks had vibration sensory testing done within 48-72 hours after treatment.
125309|NCT01673113|E1|Reported Event|Cryolipolysis|Zeltiq CoolSculpting device: This is an FDA approved cooling device used for non-invasive and selective reduction of fat around the flanks, an area commonly referred to as the “love handles.”
125310|NCT01673009|B1|Baseline|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.
Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
125311|NCT01673009|P1|Participant Flow|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.
Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
125312|NCT01673009|O1|Outcome|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.
Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
125313|NCT01673009|O1|Outcome|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.
Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
125314|NCT01673009|E1|Reported Event|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.
Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
125315|NCT01672996|B8|Baseline|Total|Total of all reporting groups
125316|NCT01672996|B7|Baseline|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg"
125317|NCT01672996|B6|Baseline|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 2.0mL/Kg"
125318|NCT01672996|B5|Baseline|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.5mL/Kg"
125319|NCT01672996|B4|Baseline|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg"
125320|NCT01672996|B3|Baseline|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 2.0mL/kg."
125321|NCT01672996|B2|Baseline|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg."
125322|NCT01672996|B1|Baseline|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.0mL/kg."
125323|NCT01672996|P3|Participant Flow|Arm 3 - Iopamidol 300mgI/mL|"Given as a single administration to the subject
Iopamidol 300 mgI/mL: Given as a single administration to the subject"
125455|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
125324|NCT01672996|P2|Participant Flow|Arm 2 - Ioforminol 200mgI/mL|"Given as a single administration to the subject
Ioforminol 200 mgI/mL: Given as a single administration to the subject"
125325|NCT01672996|P1|Participant Flow|Arm 1 - Ioforminol 160mgI/mL|"Single administration of Ioforminol 160mgI/mL given to the subject.
Ioforminol 160 mgI/mL: Given as s single administration to the subject"
125326|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg"
125327|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 2.0mL/Kg"
125328|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.5mL/Kg"
125329|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg"
125330|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 2.0mL/kg."
125331|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg."
125332|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.0mL/kg."
125333|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg"
125334|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 2.0mL/Kg"
125335|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.5mL/Kg"
125336|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg"
125337|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 2.0mL/kg."
125338|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg."
125339|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.0mL/kg."
125340|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg"
125341|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 2.0mL/Kg"
125342|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.5mL/Kg"
125343|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg"
125344|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 2.0mL/kg."
125345|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg."
125346|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.0mL/kg."
125347|NCT01672996|E7|Reported Event|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg"
125348|NCT01672996|E6|Reported Event|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 2.0mL/Kg"
125349|NCT01672996|E5|Reported Event|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.5mL/Kg"
126026|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
125350|NCT01672996|E4|Reported Event|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg"
125351|NCT01672996|E3|Reported Event|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 2.0mL/kg."
125352|NCT01672996|E2|Reported Event|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg."
125353|NCT01672996|E1|Reported Event|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.0mL/kg."
125354|NCT01672983|B7|Baseline|Total|Total of all reporting groups
125355|NCT01672983|B6|Baseline|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125356|NCT01672983|B5|Baseline|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125357|NCT01672983|B4|Baseline|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
125358|NCT01672983|B3|Baseline|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
125359|NCT01672983|B2|Baseline|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125360|NCT01672983|B1|Baseline|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125361|NCT01672983|P6|Participant Flow|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125362|NCT01672983|P5|Participant Flow|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125363|NCT01672983|P4|Participant Flow|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
125364|NCT01672983|P3|Participant Flow|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
125365|NCT01672983|P2|Participant Flow|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125366|NCT01672983|P1|Participant Flow|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125367|NCT01672983|O6|Outcome|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125368|NCT01672983|O5|Outcome|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125369|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
125370|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
125371|NCT01672983|O2|Outcome|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125372|NCT01672983|O1|Outcome|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125373|NCT01672983|O6|Outcome|Arm 6|Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
125374|NCT01672983|O5|Outcome|Arm 5|Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
125375|NCT01672983|O4|Outcome|Arm 4|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.
125376|NCT01672983|O3|Outcome|Arm 3|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.
125377|NCT01672983|O2|Outcome|Arm 2|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
125378|NCT01672983|O1|Outcome|Arm 1|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
125379|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
125380|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
125381|NCT01672983|O2|Outcome|Arm 2 + Arm 6|Arm 2: Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 6: Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125382|NCT01672983|O1|Outcome|Arm 1 + Arm 5|Arm 1: Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 5: Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125383|NCT01672983|O6|Outcome|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125384|NCT01672983|O5|Outcome|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125385|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
125386|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
125387|NCT01672983|O2|Outcome|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125388|NCT01672983|O1|Outcome|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125389|NCT01672983|E6|Reported Event|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125390|NCT01672983|E5|Reported Event|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125391|NCT01672983|E4|Reported Event|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
126027|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
125392|NCT01672983|E3|Reported Event|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
125393|NCT01672983|E2|Reported Event|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125394|NCT01672983|E1|Reported Event|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
125395|NCT01672970|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125396|NCT01672970|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria, in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125397|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125398|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125399|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125456|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
125460|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
125400|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125401|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125402|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125403|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125404|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125405|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125406|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125407|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125408|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125409|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125410|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125411|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125412|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125413|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125414|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125415|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
126028|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
125416|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125417|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125418|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125419|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125420|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125421|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125422|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125423|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125424|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125425|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125426|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125427|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125428|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125429|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125430|NCT01672970|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
125431|NCT01672957|B1|Baseline|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125432|NCT01672957|P1|Participant Flow|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil (CellCept), were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). The study protocol did not specify any treatment regimen.
125433|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125434|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125502|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
125435|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125436|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125437|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125457|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
125458|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
125459|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
125438|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125439|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125440|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125441|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125442|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125443|NCT01672957|E1|Reported Event|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
125444|NCT01672827|B1|Baseline|[18F]Flutemetamol|No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to evaluate the effectiveness of an electronic training program for orienting and interpreting Flutemetamol Positive Emission Tomography (PET) Images.
125445|NCT01672827|P1|Participant Flow|[18F]Flutemetamol|No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to show the PET Image Interpretations among investigators. The study did not enroll the blinded image Readers.
125446|NCT01672827|O1|Outcome|Specificity %|Specificity of the blinded visual PET Image Interpretations without Anatomic Images.
125447|NCT01672827|O1|Outcome|Inter-Reader Agreement|Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images.
125448|NCT01672827|O1|Outcome|Sensitivity %|Sensitivity of the blinded visual PET Image Interpretations without Anatomic Images.
125449|NCT01672827|E1|Reported Event|[18F]Flutemetamol|No adverse event data collected because no subjects were dosed in this study , therefore no subjects were at risk.
125450|NCT01672788|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study. This was an open-label, randomized, 4-way crossover trial. 36 patients were randomised to one of 4 treatment sequences and treated. Each treatment period consisted of a single dose of medication followed by 72hours of pharmacokinetic sampling, with a washout of at least 7 days between treatment periods.
125451|NCT01672788|P4|Participant Flow|R2 / T2 / R1 / T1|"Patients received the 4 treatments in the following order:
Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)
Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)
Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)
Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)"
126029|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
125452|NCT01672788|P3|Participant Flow|T2 / R2 / T1 / R1|"Patients received the 4 treatments in the following order:
Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)
Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)
Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)
Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)"
125453|NCT01672788|P2|Participant Flow|R1 / T1 / R2 / T2|"Patients received the 4 treatments in the following order:
Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)
Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)
Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)
Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)"
125454|NCT01672788|P1|Participant Flow|T1 / R1 / T2 / R2|"Patients received the 4 treatments in the following order:
Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)
Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)
Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)
Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)"
125461|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
125462|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
125463|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
125464|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
125465|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
125466|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
125467|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
125468|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
125469|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
125470|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
125471|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
125472|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
125473|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
125474|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
125475|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
125476|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
125477|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
125478|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
125479|NCT01672788|E4|Reported Event|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
125480|NCT01672788|E3|Reported Event|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
125481|NCT01672788|E2|Reported Event|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
125482|NCT01672788|E1|Reported Event|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
125483|NCT01672723|B1|Baseline|Naltrexone First and Placebo First|Includes groups randomized to receive naltrexone first and placebo first.
125484|NCT01672723|P2|Participant Flow|Placebo First, Then Naltrexone|Participants took 4 placebo pills over 4 days (one pill a day), followed by a 10-day washout period, followed by 4 naltrexone pills for 4 days (25 mg on days 1 and 2, 50mg on days 3 and 4)
125485|NCT01672723|P1|Participant Flow|Naltrexone First, Then Placebo|Participants took 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) followed by a 10-day washout period and finally, 4 matched placebo pills for another 4 days.
125486|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
126030|NCT01669122|E4|Reported Event|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
125487|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.
Naltrexone"
125488|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
125489|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.
Naltrexone"
125490|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
125491|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.
Naltrexone"
125492|NCT01672723|E2|Reported Event|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
125493|NCT01672723|E1|Reported Event|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
125494|NCT01672658|B3|Baseline|Total|Total of all reporting groups
125495|NCT01672658|B2|Baseline|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
125496|NCT01672658|B1|Baseline|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
125497|NCT01672658|P2|Participant Flow|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
125498|NCT01672658|P1|Participant Flow|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
125499|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
125500|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
125501|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
125503|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
125504|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
125505|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
125506|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
125507|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
125508|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
136563|NCT01627002|O8|Outcome|Part B PA401 3.0 mg|
125509|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
125510|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
125511|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
125512|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
125513|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
125514|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
125515|NCT01672658|E2|Reported Event|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
125516|NCT01672658|E1|Reported Event|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
125517|NCT01672294|B5|Baseline|Total|Total of all reporting groups
125518|NCT01672294|B4|Baseline|Relaxation Meditation - Patient|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD..
125519|NCT01672294|B3|Baseline|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
125520|NCT01672294|B2|Baseline|Caregiver Outlook - Patient|Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.
125521|NCT01672294|B1|Baseline|Caregiver Outlook - Caregiver|Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.
125522|NCT01672294|P4|Participant Flow|Relaxation Meditation - Patient|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
125523|NCT01672294|P3|Participant Flow|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
125524|NCT01672294|P2|Participant Flow|Caregiver Outlook - Patient|"Intervention: Three facilitator-led preparation and life completion sessions with caregiver.
Intervention: Three facilitator-led preparation and life completion sessions with caregiver.
Topics included life review, issues of forgiveness and heritage and legacy."
126154|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
125525|NCT01672294|P1|Participant Flow|Caregiver Outlook - Caregiver|"Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Intervention: Three facilitator-led preparation and life completion sessions with caregiver.
Topics included life review, issues of forgiveness and heritage and legacy."
125526|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
125527|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
125528|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
125529|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
125530|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
125531|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
125532|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
125533|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
125534|NCT01672294|O2|Outcome|Relaxation Meditation - Patient|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
125535|NCT01672294|O1|Outcome|Caregiver Outlook - Patient|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
125536|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
125537|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
125538|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
125539|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
125540|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
125541|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
125542|NCT01672294|E4|Reported Event|Relaxation Meditation - Patient|Patients of the caregivers in the Attention Control arm.
125543|NCT01672294|E3|Reported Event|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
125544|NCT01672294|E2|Reported Event|Caregiver Outlook - Patient|Patients of the caregivers in the Outlook Intervention arm.
125545|NCT01672294|E1|Reported Event|Caregiver Outlook - Caregiver|Intervention: Three facilitator-led sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy.
125546|NCT01671839|B1|Baseline|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
125547|NCT01671839|P1|Participant Flow|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
125548|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
125549|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
125550|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
125551|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
125552|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
125553|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
125554|NCT01671839|E1|Reported Event|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
125555|NCT01671748|B3|Baseline|Total|Total of all reporting groups
125556|NCT01671748|B2|Baseline|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
125557|NCT01671748|B1|Baseline|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
125558|NCT01671748|P2|Participant Flow|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
125559|NCT01671748|P1|Participant Flow|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
125560|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
125561|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
125562|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
125563|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
125564|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
125565|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
125566|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
125567|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
125568|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
125569|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
125570|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
125571|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
125572|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
125573|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
125574|NCT01671748|E2|Reported Event|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
125575|NCT01671748|E1|Reported Event|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
125576|NCT01671605|B3|Baseline|Total|Total of all reporting groups
125577|NCT01671605|B2|Baseline|Controls|Controls with normal kidney function (Control)
125578|NCT01671605|B1|Baseline|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
125579|NCT01671605|P2|Participant Flow|Controls|Controls with normal kidney function (Control)
125580|NCT01671605|P1|Participant Flow|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
125581|NCT01671605|O2|Outcome|Controls|Controls with normal kidney function (Control)
125582|NCT01671605|O1|Outcome|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
125583|NCT01671605|E2|Reported Event|Controls|Controls with normal kidney function (Control)
125584|NCT01671605|E1|Reported Event|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
125585|NCT01671488|B1|Baseline|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
125596|NCT01671293|O2|Outcome|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
126763|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
125586|NCT01671488|P1|Participant Flow|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
125587|NCT01671488|O1|Outcome|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
125618|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125619|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125620|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125588|NCT01671488|O1|Outcome|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
125589|NCT01671488|O1|Outcome|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
125590|NCT01671488|E1|Reported Event|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
125591|NCT01671293|B3|Baseline|Total|Total of all reporting groups
125592|NCT01671293|B2|Baseline|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
125593|NCT01671293|B1|Baseline|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
125594|NCT01671293|P2|Participant Flow|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
125595|NCT01671293|P1|Participant Flow|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
125739|NCT01670656|O2|Outcome|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
126954|NCT01665170|O1|Outcome|Placebo|Placebo arm
125597|NCT01671293|O1|Outcome|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
125598|NCT01671293|E2|Reported Event|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
125621|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125622|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125623|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
128528|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
125599|NCT01671293|E1|Reported Event|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
125600|NCT01671280|B1|Baseline|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
125601|NCT01671280|P1|Participant Flow|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
125602|NCT01671280|O1|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
125603|NCT01671280|O1|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
125604|NCT01671280|O1|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
125605|NCT01671280|E1|Reported Event|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
125606|NCT01671111|B1|Baseline|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
125607|NCT01671111|P1|Participant Flow|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 milligram per kilogram per day (mg/kg/day) (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
125608|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
125609|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
125610|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
125611|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
125612|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
125613|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
125740|NCT01670656|O1|Outcome|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125614|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
125615|NCT01671111|E1|Reported Event|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
125616|NCT01671059|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125617|NCT01671059|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125624|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125625|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125626|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125627|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125628|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125629|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125630|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125631|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125632|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125633|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125634|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125635|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125636|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125637|NCT01671059|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125638|NCT01671059|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
125639|NCT01670825|B3|Baseline|Total|Total of all reporting groups
125640|NCT01670825|B2|Baseline|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125641|NCT01670825|B1|Baseline|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125642|NCT01670825|P2|Participant Flow|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125643|NCT01670825|P1|Participant Flow|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125644|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125645|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125646|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125647|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125648|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125649|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125650|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125651|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125652|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125653|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125654|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125655|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125656|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125657|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125658|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125659|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125660|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125661|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125662|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125663|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125664|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125665|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125666|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125667|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125668|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125741|NCT01670656|O5|Outcome|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
126955|NCT01665170|O2|Outcome|Placebo|Placebo arm
125669|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125670|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125671|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125672|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125673|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125674|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125675|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125676|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125677|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125678|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125679|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125680|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125681|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125682|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125683|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125684|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125685|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125686|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125687|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125688|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125689|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125690|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125742|NCT01670656|O4|Outcome|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125691|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125692|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125693|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125694|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125695|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125696|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125697|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125698|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125699|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125700|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125701|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125702|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve
Local anethestic injection"
125703|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve
Local anethestic injection"
125704|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125705|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125706|NCT01670825|E2|Reported Event|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
125707|NCT01670825|E1|Reported Event|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
125708|NCT01670721|B1|Baseline|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
125709|NCT01670721|P1|Participant Flow|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
125710|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
125743|NCT01670656|O3|Outcome|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125711|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
125712|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
125713|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
125714|NCT01670721|E1|Reported Event|Aflibercept + FOLFIRI(Irinotecan, 5-Fluorouracil & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment (maximum exposure: Week 99).
125715|NCT01670656|B6|Baseline|Total|Total of all reporting groups
136564|NCT01627002|O7|Outcome|Part B PA401 1.0 mg|
125716|NCT01670656|B5|Baseline|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125717|NCT01670656|B4|Baseline|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125718|NCT01670656|B3|Baseline|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125719|NCT01670656|B2|Baseline|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125720|NCT01670656|B1|Baseline|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125721|NCT01670656|P5|Participant Flow|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125722|NCT01670656|P4|Participant Flow|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125723|NCT01670656|P3|Participant Flow|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125724|NCT01670656|P2|Participant Flow|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125725|NCT01670656|P1|Participant Flow|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125726|NCT01670656|O5|Outcome|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125727|NCT01670656|O4|Outcome|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125728|NCT01670656|O3|Outcome|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125729|NCT01670656|O2|Outcome|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125730|NCT01670656|O1|Outcome|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125731|NCT01670656|O5|Outcome|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125732|NCT01670656|O4|Outcome|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125733|NCT01670656|O3|Outcome|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125734|NCT01670656|O2|Outcome|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125735|NCT01670656|O1|Outcome|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125736|NCT01670656|O5|Outcome|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125737|NCT01670656|O4|Outcome|ENG-E2 125/300 mcg|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125738|NCT01670656|O3|Outcome|ENG-E2 100/300 mcg|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125744|NCT01670656|O2|Outcome|NOMAC-E2 900/300 mcg|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125745|NCT01670656|O1|Outcome|NOMAC-E2 700/300 mcg|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125746|NCT01670656|E5|Reported Event|Placebo|Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125747|NCT01670656|E4|Reported Event|ENG-E2 (125/300 mcg)|ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125748|NCT01670656|E3|Reported Event|ENG-E2 (100/300 mcg)|ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125749|NCT01670656|E2|Reported Event|NOMAC-E2 (900/300 mcg)|NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
125750|NCT01670656|E1|Reported Event|NOMAC-E2 (700/300 mcg)|NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days
125751|NCT01670526|B3|Baseline|Total|Total of all reporting groups
125752|NCT01670526|B2|Baseline|Placebo|"Placebo
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125753|NCT01670526|B1|Baseline|Rivastigmine|"Rivastigmine transdermal patch
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125754|NCT01670526|P2|Participant Flow|Placebo|"Placebo
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
136565|NCT01627002|O6|Outcome|Part A Placebo|
125755|NCT01670526|P1|Participant Flow|Rivastigmine|"Rivastigmine transdermal patch
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125756|NCT01670526|O2|Outcome|Placebo|"Placebo
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125757|NCT01670526|O1|Outcome|Rivastigmine|"Rivastigmine transdermal patch
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125758|NCT01670526|O2|Outcome|Placebo|"Placebo
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125759|NCT01670526|O1|Outcome|Rivastigmine|"Rivastigmine transdermal patch
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125760|NCT01670526|O2|Outcome|Placebo|"Placebo
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125761|NCT01670526|O1|Outcome|Rivastigmine|"Rivastigmine transdermal patch
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125762|NCT01670526|O2|Outcome|Placebo|"Placebo
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125763|NCT01670526|O1|Outcome|Rivastigmine|"Rivastigmine transdermal patch
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125764|NCT01670526|E2|Reported Event|Placebo|"Placebo
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125765|NCT01670526|E1|Reported Event|Rivastigmine|"Rivastigmine transdermal patch
Rivastigmine Transdermal Patch: Cholinesterase Inhibitor"
125766|NCT01670487|B3|Baseline|Total|Total of all reporting groups
125767|NCT01670487|B2|Baseline|Nature's Tears|Applied Nature's Tears in a topical stream of 4 to 10 seconds duration to skin
125768|NCT01670487|B1|Baseline|Vapocoolant (Pain Ease Medium Stream)|Applied Vapoccolant in a topical stream of 4 to 10 seconds duration to skin
125769|NCT01670487|P2|Participant Flow|Nature's Tears|"Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.
Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin."
125770|NCT01670487|P1|Participant Flow|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.
Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
125771|NCT01670487|O2|Outcome|Placebo (Nature's Tears)|Application of the stream steadily for 4 to 10 seconds
125772|NCT01670487|O1|Outcome|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.
Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
125773|NCT01670487|E2|Reported Event|Nature's Tears|"Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.
Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin."
125774|NCT01670487|E1|Reported Event|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.
Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
125775|NCT01670279|B4|Baseline|Total|Total of all reporting groups
125776|NCT01670279|B3|Baseline|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125777|NCT01670279|B2|Baseline|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125778|NCT01670279|B1|Baseline|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125779|NCT01670279|P4|Participant Flow|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125780|NCT01670279|P3|Participant Flow|Brexpiprazole-Cohort 3|In the titration phase, participants were to receive 0.5 mg brexpiprazole or placebo QD for 7 days, followed by 1 mg brexpiprazole or placebo QD for 7 days, and then 2 mg brexpiprazole or placebo QD for 7 days. In the fixed dose phase, participants were to receive 3 mg brexpiprazole or placebo QD for 14 days. However, Cohort 3 was not conducted due to safety and tolerability results from Cohorts 1 and 2.
125781|NCT01670279|P2|Participant Flow|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125782|NCT01670279|P1|Participant Flow|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125783|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125784|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125785|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125786|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125787|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125788|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125789|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125790|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125791|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125792|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125793|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125794|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125795|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125796|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125797|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125798|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125799|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125800|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125801|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125802|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125803|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125804|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125805|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125806|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125807|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125808|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125809|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125810|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125811|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125812|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125813|NCT01670279|E3|Reported Event|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
125814|NCT01670279|E2|Reported Event|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
125815|NCT01670279|E1|Reported Event|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
125816|NCT01670201|B1|Baseline|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Mepilex Transfer Ag: Silver dressing"
125817|NCT01670201|P1|Participant Flow|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Mepilex Transfer Ag: Silver dressing"
125818|NCT01670201|O1|Outcome|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Mepilex Transfer Ag: Silver dressing"
125819|NCT01670201|O1|Outcome|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Mepilex Transfer Ag: Silver dressing"
125820|NCT01670201|E1|Reported Event|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Mepilex Transfer Ag: Silver dressing"
125821|NCT01670045|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125822|NCT01670045|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joint Count (DAS28) who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125823|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125824|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125825|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125826|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125827|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125828|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125829|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125830|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125882|NCT01669863|P1|Participant Flow|Use of ECMO in Non-intubated Patients|"ECMO used in non-intubated patients with ARDS
ECMO
ECMO in non-intubated patients"
125883|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|ECMO in non-intubated patients
125831|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125832|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125833|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125834|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125835|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125836|NCT01670045|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA and the DAS28 joint scores who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
125837|NCT01670019|B3|Baseline|Total|Total of all reporting groups
125838|NCT01670019|B2|Baseline|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
125839|NCT01670019|B1|Baseline|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability
Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
125840|NCT01670019|P2|Participant Flow|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
125841|NCT01670019|P1|Participant Flow|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability
Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
125842|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
125843|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability
Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
125844|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
125873|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125845|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability
Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
125846|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
125847|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability
Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
125848|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
125849|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability
Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
125884|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|ECMO in non-intubated patients
136566|NCT01627002|O5|Outcome|Part A PA401 10 mg|
125850|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
125851|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability
Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
125852|NCT01670019|E2|Reported Event|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
125853|NCT01670019|E1|Reported Event|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability
Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
125854|NCT01669902|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125855|NCT01669902|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125856|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125857|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125858|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125859|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125860|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125861|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125862|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125863|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125864|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125865|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125866|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125867|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125868|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125869|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125870|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125871|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125872|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
126956|NCT01665170|O1|Outcome|Verum|Verum arm - Pascoflair 425mg
125874|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125875|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125876|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125877|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125878|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125879|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125880|NCT01669902|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
125881|NCT01669863|B1|Baseline|Use of ECMO in Non-intubated Patients|ECMO group
125885|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|"ECMO will be used in non-intubated patients with ARDS
ECMO
ECMO in non-intubated patients"
125886|NCT01669863|E1|Reported Event|Use of ECMO in Non-intubated Patients|Patients on ECMO
125887|NCT01669811|B3|Baseline|Total|Total of all reporting groups
125888|NCT01669811|B2|Baseline|D961H 20 mg QD + Placebo|D961H 20 mg once daily along with placebo
125889|NCT01669811|B1|Baseline|D961H 20 mg BID|D961H 20 mg twice Daily
125890|NCT01669811|P2|Participant Flow|D961H 20 mg QD + Placebo|Hard capsule unidentifiable to D961H capsule 20 mg
125891|NCT01669811|P1|Participant Flow|D961H 20 mg BID|Hard capsule containing 22.3 mg of D961H as enteric coated pellets
125892|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
125893|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
125894|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
125895|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
125896|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
125897|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
125898|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
125899|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
125900|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
125901|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
125902|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
125903|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
125904|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
125905|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
125906|NCT01669811|E2|Reported Event|D961H 20 mg QD + Placebo|D961H 20 mg once daily along with placebo
125907|NCT01669811|E1|Reported Event|D961H 20 mg BID|D961H 20 mg twice Daily
125908|NCT01669785|B4|Baseline|Total|Total of all reporting groups
125909|NCT01669785|B3|Baseline|Group C|NUPRO Classic Prophy Paste.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.Leave in contact for 60 seconds, rinse with water and expectorate.
125910|NCT01669785|B2|Baseline|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125911|NCT01669785|B1|Baseline|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin. Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
125912|NCT01669785|P3|Participant Flow|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
125913|NCT01669785|P2|Participant Flow|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125914|NCT01669785|P1|Participant Flow|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
125915|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
125916|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125917|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
126024|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
126957|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
125918|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
125919|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125920|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
125921|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
125922|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125923|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
125924|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
126163|NCT01668784|B3|Baseline|Total|Total of all reporting groups
125925|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125926|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
125927|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
125928|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125929|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
125930|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
125931|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125932|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
125933|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
125934|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125935|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
125936|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
125937|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125938|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
125939|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
125940|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125941|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125942|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
125943|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125944|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
125945|NCT01669785|E3|Reported Event|Group C|"NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate."
125946|NCT01669785|E2|Reported Event|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate."
125947|NCT01669785|E1|Reported Event|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate."
125948|NCT01669720|B3|Baseline|Total|Total of all reporting groups
125949|NCT01669720|B2|Baseline|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
125950|NCT01669720|B1|Baseline|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years
Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
125951|NCT01669720|P2|Participant Flow|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
136567|NCT01627002|O4|Outcome|Part A PA401 3.0 mg|
125952|NCT01669720|P1|Participant Flow|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years
Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
125953|NCT01669720|O2|Outcome|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
125954|NCT01669720|O1|Outcome|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years
Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
125955|NCT01669720|E2|Reported Event|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
125956|NCT01669720|E1|Reported Event|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years
Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
125957|NCT01669629|B1|Baseline|All Subjects|All subjects who were enrolled in the study.
125958|NCT01669629|P2|Participant Flow|Etafilcon A \ Delefilcon A|"6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear
delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.
etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use."
125959|NCT01669629|P1|Participant Flow|Delefilcon A \ Etafilcon A|"6-10 days of delefilcon A soft contact lens wear first then 6-10 days of etafilcon A soft contact lens wear
delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.
etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use."
125960|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
125961|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
125962|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
125963|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
125964|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
125965|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
125966|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
125967|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
125968|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
125969|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
125970|NCT01669629|E2|Reported Event|Etafilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
125971|NCT01669629|E1|Reported Event|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
125972|NCT01669603|B3|Baseline|Total|Total of all reporting groups
125973|NCT01669603|B2|Baseline|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
125974|NCT01669603|B1|Baseline|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.
Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
125975|NCT01669603|P2|Participant Flow|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
125976|NCT01669603|P1|Participant Flow|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.
Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
125977|NCT01669603|O2|Outcome|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
126025|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A was administered orally as a single dose treatment.
125978|NCT01669603|O1|Outcome|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.
Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
125979|NCT01669603|E2|Reported Event|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
125980|NCT01669603|E1|Reported Event|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.
Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
125981|NCT01669577|B1|Baseline|Severe Trauma Patients|Hypotensive Patients (SBP<90mmHg), severe TBI, high energy traumas All patients must have calculated ISS >15 to be included and a written informed consent should be available
125982|NCT01669577|P1|Participant Flow|Severe Trauma Patients|"intervention : analysis of blood samples
analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)
analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR collection of vital signs, blood chemistry; severity scores and intensive care unit(ICU) LOS(length of stay) were recorded"
125983|NCT01669577|O1|Outcome|Severe Trauma Patients|"intervention : analysis of blood samples; vital signs and clinical outcomes recorded
analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)
analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR"
126201|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
125984|NCT01669577|E1|Reported Event|Severe Trauma Patients|"intervention : analysis of blood samples
analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)
analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR"
125985|NCT01669174|B3|Baseline|Total|Total of all reporting groups
125986|NCT01669174|B2|Baseline|Placebo|Placebo to BYM338 30mg/kg
125987|NCT01669174|B1|Baseline|BYM338|30 mg/kg
125988|NCT01669174|P2|Participant Flow|Placebo|Placebo to BYM338 30mg/kg
125989|NCT01669174|P1|Participant Flow|BYM338|30 mg/kg
125990|NCT01669174|O1|Outcome|BYM338|30 mg/kg
125991|NCT01669174|O1|Outcome|BYM338|30 mg/kg
125992|NCT01669174|O1|Outcome|BYM338|30 mg/kg
125993|NCT01669174|O2|Outcome|Placebo|Placebo to BYM338 30mg/kg
125994|NCT01669174|O1|Outcome|BYM338|30 mg/kg
125995|NCT01669174|O2|Outcome|Placebo|Placebo to BYM338 30mg/kg
125996|NCT01669174|O1|Outcome|BYM338|30 mg/kg
125997|NCT01669174|E2|Reported Event|Placebo|Placebo to BYM338 30mg/kg
125998|NCT01669174|E1|Reported Event|BYM338 30mg/kg|BYM338 30mg/kg
125999|NCT01669148|B1|Baseline|All Study Participants|All study participants in both arms. 496 enrolled and 426 completed study, but no information available to distinguish study arms.
126000|NCT01669148|P1|Participant Flow|All Study Participants|All participants enrolled in study
126001|NCT01669148|O2|Outcome|Tomosynthesis Alone First Then Conventional+Tomo 1 mo. Later|"Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).
Conventional: conventional (2D) imaging (standard mammography)"
126002|NCT01669148|O1|Outcome|Conventional + Tomosynthesis First Then Tomo Alone 1 mo. Later|"Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).
Conventional: conventional (2D) imaging (standard mammography)"
126003|NCT01669148|E1|Reported Event|All Study Participants|All participants enrolled in the study
126004|NCT01669122|B1|Baseline|Safety Population|Baseline measurements were performed for safety population which included all participants in the study who were dispensed at least one of the study treatment. Out of 40 randomized participants, one participant did not receive any treatment and was lost to follow-up.
126005|NCT01669122|P1|Participant Flow|Total Participants|
126006|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
126007|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
126008|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
126009|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
126010|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
126011|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
126012|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
126013|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
126014|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
126015|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
126016|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
126017|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
126018|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
126019|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
126020|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
126021|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
126022|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
126023|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
126031|NCT01669122|E3|Reported Event|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
126032|NCT01669122|E2|Reported Event|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
126033|NCT01669122|E1|Reported Event|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
126034|NCT01668836|B5|Baseline|Total|Total of all reporting groups
126035|NCT01668836|B4|Baseline|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126036|NCT01668836|B3|Baseline|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126037|NCT01668836|B2|Baseline|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126038|NCT01668836|B1|Baseline|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126039|NCT01668836|P4|Participant Flow|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days"
126040|NCT01668836|P3|Participant Flow|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days"
126202|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
126041|NCT01668836|P2|Participant Flow|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126042|NCT01668836|P1|Participant Flow|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126043|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126044|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126045|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126046|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126047|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126048|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126049|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126050|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126051|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126052|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126053|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126054|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126055|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126056|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126057|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126058|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126059|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126060|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126061|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126062|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126063|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126064|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126065|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126066|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126067|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126068|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126510|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126069|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126070|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126071|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126072|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1,000kcal per day for 30 days"
126073|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126074|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126075|NCT01668836|O4|Outcome|Women With Caloric Restriction|12 women will follow a 1000Kcal/day of caloric restriction
126076|NCT01668836|O3|Outcome|Men With Caloric Restriction|12 men will follow a 1000Kcal/day of caloric restriction
126077|NCT01668836|O2|Outcome|Women With Resveratrol|12 women will receive a pill with 500mg of resveratrol
126078|NCT01668836|O1|Outcome|Men With Resveratrol|12 men will receive a pill with 500mg of resveratrol
126079|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days"
126080|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days"
126081|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126082|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126083|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days"
126084|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days"
126085|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126086|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126087|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days"
126088|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days
Caloric restriction: Diet of 1000kcal per day for 30 days"
126089|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126090|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
126091|NCT01668836|E4|Reported Event|Women With Caloric Restriction|12 women will follow a 1000Kcal/day of caloric restriction
126092|NCT01668836|E3|Reported Event|Men With Caloric Restriction|12 men will follow a 1000Kcal/day of caloric restriction
126093|NCT01668836|E2|Reported Event|Women With Resveratrol|12 women will receive a pill with 500mg of resveratrol
126094|NCT01668836|E1|Reported Event|Men With Resveratrol|12 men will receive a pill with 500mg of resveratrol
126095|NCT01668797|B3|Baseline|Total|Total of all reporting groups
126096|NCT01668797|B2|Baseline|Phase C - Placebo (Double-Blind Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
126097|NCT01668797|B1|Baseline|Phase C - Brexpiprazole (Double-Blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126098|NCT01668797|P4|Participant Flow|Phase C - Placebo (Double-Blind Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
126099|NCT01668797|P3|Participant Flow|Phase C - Brexpiprazole (Double-Blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126100|NCT01668797|P2|Participant Flow|Phase B (Stabilization Phase)|This single-blind stabilization phase was to titrate participants to a dose of brexpiprazole (1 to 4 mg/day) that would maintain stability of psychotic symptoms over 12 consecutive weeks (within a maximum of 36 weeks), while minimizing tolerability issues.
126101|NCT01668797|P1|Participant Flow|Phase A (Conversion Phase)|The purpose of the open-label conversion phase was 2-fold: 1) to cross-titrate the participants current antipsychotic treatment to brexpiprazole monotherapy over a period of 1 to 4 weeks and 2) to allow washout of prohibited medications in preparation for the stabilization phase.
126102|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126103|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126104|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126105|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126106|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126107|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126108|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126958|NCT01665170|O1|Outcome|Placebo|Placebo arm
126109|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126110|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126111|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126112|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126113|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126114|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126115|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126116|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126117|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126118|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126203|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
126119|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126120|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126121|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126122|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126123|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126124|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126125|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126126|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126127|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126128|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126129|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126130|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126131|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126132|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126133|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126134|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126135|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126136|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126137|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126138|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126139|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126140|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126141|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126142|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126143|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126144|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126145|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126146|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126147|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126148|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126149|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126150|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126151|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126152|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126153|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126155|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126156|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126157|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126158|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
126159|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126160|NCT01668797|E3|Reported Event|Placebo (Double-blnd Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
126161|NCT01668797|E2|Reported Event|Brexpiprazole (Double-blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
126162|NCT01668797|E1|Reported Event|Single Blind Stabilization Phase|This single-blind stabilization phase was to titrate participants to a dose of brexpiprazole (1 to 4 mg/day) that would maintain stability of psychotic symptoms over 12 consecutive weeks (within a maximum of 36 weeks), while minimizing tolerability issues.
126164|NCT01668784|B2|Baseline|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126165|NCT01668784|B1|Baseline|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126166|NCT01668784|P2|Participant Flow|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126167|NCT01668784|P1|Participant Flow|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126168|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126169|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126170|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126171|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126172|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126173|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126174|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126175|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126176|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126177|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126178|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126179|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126180|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126181|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126182|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126183|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126184|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126185|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126186|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126187|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126188|NCT01668784|E2|Reported Event|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126511|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126189|NCT01668784|E1|Reported Event|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
126190|NCT01668667|B5|Baseline|Total|Total of all reporting groups
126191|NCT01668667|B4|Baseline|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
126192|NCT01668667|B3|Baseline|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
126193|NCT01668667|B2|Baseline|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
126194|NCT01668667|B1|Baseline|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
126195|NCT01668667|P4|Participant Flow|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
126196|NCT01668667|P3|Participant Flow|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
126197|NCT01668667|P2|Participant Flow|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
126198|NCT01668667|P1|Participant Flow|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
126199|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
126200|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
126204|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
126205|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
126206|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
126207|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
126208|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
126209|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
126210|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
126211|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
126212|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
126213|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
126214|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
126215|NCT01668667|E4|Reported Event|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PMmatching placebo.
126216|NCT01668667|E3|Reported Event|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
126217|NCT01668667|E2|Reported Event|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
126218|NCT01668667|E1|Reported Event|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
126219|NCT01668654|B1|Baseline|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126220|NCT01668654|P1|Participant Flow|Retigabine/Ezogabine TID|Participants (par.) received retigabine/ezogabine as immediate release (IR) tablets three times a day (TID) as add-on therapy. Six dose strengths (25 milligrams(mg)/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg per day (mg/day) (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126221|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126222|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126223|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126512|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
126224|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126225|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126226|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126449|NCT01668004|O1|Outcome|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
126227|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126228|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126229|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126230|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126231|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126232|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126233|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126234|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126284|NCT01668589|P1|Participant Flow|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126513|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
126235|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126236|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126237|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126238|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126239|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126240|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126241|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126242|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126243|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126244|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126245|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126285|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126514|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
126246|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126247|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126248|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126249|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126250|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126251|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126252|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126253|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126254|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126255|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126256|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126286|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126515|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126257|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126258|NCT01668654|E1|Reported Event|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability) over the course of this long-term open-label extension study. Physicians used their clinical judgment in making dose adjustments. Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
126259|NCT01668628|B4|Baseline|Total|Total of all reporting groups
126260|NCT01668628|B3|Baseline|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
126261|NCT01668628|B2|Baseline|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
126450|NCT01668004|O1|Outcome|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
126262|NCT01668628|B1|Baseline|Incident PD Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dia;ysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
126263|NCT01668628|P3|Participant Flow|Prevalent Hemodialysis (HD) Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
126264|NCT01668628|P2|Participant Flow|Prevalent Peritoneal Dialysis (PD) Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
126265|NCT01668628|P1|Participant Flow|Incident Peritoneal Dialysis(PD) Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
126266|NCT01668628|O2|Outcome|Overhydration Group|Hemodialysis patients with baseline OH value >+2L
126267|NCT01668628|O1|Outcome|Normohydration Group|Hemodialysis patients with baseline -2L<OH value <+2L
126268|NCT01668628|O2|Outcome|Overhydration Group|Peritoneal dialysis patients with baseline OH value >+2L
126269|NCT01668628|O1|Outcome|Normohydration Group|Peritoneal dialysis patients with baseline -2L<OH value <+2L
126270|NCT01668628|O3|Outcome|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
126271|NCT01668628|O2|Outcome|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
126272|NCT01668628|O1|Outcome|Incident PD Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
126273|NCT01668628|E3|Reported Event|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
126274|NCT01668628|E2|Reported Event|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
126275|NCT01668628|E1|Reported Event|Incident PD Patients|First treatment for ESRD by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is CAPD or APD and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
126276|NCT01668589|B5|Baseline|Total|Total of all reporting groups
126277|NCT01668589|B4|Baseline|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126278|NCT01668589|B3|Baseline|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126279|NCT01668589|B2|Baseline|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126280|NCT01668589|B1|Baseline|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126281|NCT01668589|P4|Participant Flow|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126282|NCT01668589|P3|Participant Flow|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126283|NCT01668589|P2|Participant Flow|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126561|NCT01667731|B6|Baseline|Total|Total of all reporting groups
126287|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126288|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126289|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126290|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126291|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126292|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126451|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
126293|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126294|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126295|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126296|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126297|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126298|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126299|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126300|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126301|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126302|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126303|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126304|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126305|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126306|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126307|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126308|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126309|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126310|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126311|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126312|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126313|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126505|NCT01667900|O4|Outcome|Placebo (Part B-T2DM|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126959|NCT01665170|E2|Reported Event|Verum|Verum arm - Pascoflair 425mg
126314|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126315|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126316|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
126317|NCT01668589|E4|Reported Event|Belgium|Prolia 60 mg SC Q6M
126318|NCT01668589|E3|Reported Event|Greece|Prolia 60 mg SC Q6M
126319|NCT01668589|E2|Reported Event|Austria|Prolia 60 mg SC Q6M
126320|NCT01668589|E1|Reported Event|Germany|Prolia 60 mg SC Q6M
126321|NCT01668173|B1|Baseline|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
126525|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
126322|NCT01668173|P1|Participant Flow|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
126323|NCT01668173|O1|Outcome|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
126324|NCT01668173|E1|Reported Event|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
126325|NCT01668030|B1|Baseline|All Study Participants|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.
Enzymatic treatment versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
126326|NCT01668030|P2|Participant Flow|Enzymatic Agent Treatment Side of Face|Enzymatic agent applied to cheek
126327|NCT01668030|P1|Participant Flow|Bacitracin Treated Side of Face|Bacitractin was applied to one side of face.
126328|NCT01668030|O2|Outcome|Enzymatic Agent Treatment Side of Face|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.
Enzymatic agent versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
126329|NCT01668030|O1|Outcome|Bacitracin Treated Side of Face|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.
Enzymatic agent versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
126330|NCT01668030|E1|Reported Event|All Study Participants|"Double Blind (masked to subject, caregiver, & outcome assessor. Intervention is that either drug is randomized into being applied to either right or left side of face.
Enzymatic treatment versus Bacitracin: Person is their own control. Ointments randomly applied to either side of face."
126331|NCT01668017|B6|Baseline|Total|Total of all reporting groups
126332|NCT01668017|B5|Baseline|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126333|NCT01668017|B4|Baseline|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126334|NCT01668017|B3|Baseline|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126335|NCT01668017|B2|Baseline|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126336|NCT01668017|B1|Baseline|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21- day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126337|NCT01668017|P5|Participant Flow|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126338|NCT01668017|P4|Participant Flow|Part 1: Pimasertib 30 mg in Hepatocellular Carcinoma (HCC)|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126339|NCT01668017|P3|Participant Flow|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126340|NCT01668017|P2|Participant Flow|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126341|NCT01668017|P1|Participant Flow|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 milligram (mg) twice a day (BID) in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126342|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126506|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126960|NCT01665170|E1|Reported Event|Placebo|Placebo arm
126343|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126344|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126345|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126346|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126526|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
126347|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126348|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126349|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126350|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126351|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg twice a day (BID) until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126352|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126353|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126354|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126355|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126356|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126357|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126358|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126359|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126360|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126361|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126362|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126363|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126364|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126365|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126366|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126367|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126368|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126369|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126370|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126371|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126372|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126373|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126374|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126375|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126376|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126377|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126378|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126379|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126380|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126381|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126382|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126383|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126384|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with HCC were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126385|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126386|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126387|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126388|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126389|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126390|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126391|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126392|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126393|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126507|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126961|NCT01665157|B4|Baseline|Total|Total of all reporting groups
126394|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126395|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126396|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126397|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126398|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126399|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126400|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126401|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 milligram (mg) twice a day (BID) in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126402|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126403|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126404|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126405|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126406|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126407|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126408|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126409|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126410|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126411|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126412|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126413|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126414|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126415|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126416|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126417|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126418|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126508|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126419|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126420|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126421|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126422|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126423|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126424|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126425|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126426|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126427|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126428|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126429|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126430|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126431|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126432|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126433|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126434|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126435|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126436|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126437|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
126438|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
126439|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
126440|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126441|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126442|NCT01668017|E5|Reported Event|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126443|NCT01668017|E4|Reported Event|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
128304|NCT01660321|B1|Baseline|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
126444|NCT01668017|E3|Reported Event|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126445|NCT01668017|E2|Reported Event|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126446|NCT01668017|E1|Reported Event|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
126447|NCT01668004|B1|Baseline|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
126448|NCT01668004|P1|Participant Flow|GLM 50 mg|Golimumab (GLM) given subcutaneously at a dose of 50 mg once monthly for up to 12 months
126452|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
126453|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
126454|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
126455|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
126456|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
126457|NCT01668004|E1|Reported Event|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
126458|NCT01667978|B3|Baseline|Total|Total of all reporting groups
126459|NCT01667978|B2|Baseline|Control|"o PI therapy, control group
Norethindrone acetate"
126460|NCT01667978|B1|Baseline|Protease Inhibitor|"Study group with PI: atazanavir ritonavir
Norethindrone acetate"
126461|NCT01667978|P2|Participant Flow|Control|"no PI therapy, control group
Norethindrone acetate
17 controls (4 no ARV)"
126462|NCT01667978|P1|Participant Flow|Protease Inhibitor|"Study group with PI: atazanavir ritonavir
Norethindrone acetate
16 HIV positive on PI (atazanavir ritonavir 10, darunovir, lopinavir)"
126463|NCT01667978|O2|Outcome|Control|"o PI therapy, control group
Norethindrone acetate"
126464|NCT01667978|O1|Outcome|Protease Inhibitor|"Study group with PI: atazanavir ritonavir
Norethindrone acetate"
126465|NCT01667978|E2|Reported Event|Control|"o PI therapy, control group
Norethindrone acetate"
126466|NCT01667978|E1|Reported Event|Protease Inhibitor|"Study group with PI: atazanavir ritonavir
Norethindrone acetate"
126467|NCT01667926|B3|Baseline|Total|Total of all reporting groups
126468|NCT01667926|B2|Baseline|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.
Placebo"
126469|NCT01667926|B1|Baseline|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.
Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
126470|NCT01667926|P3|Participant Flow|Screen Fail/No Baseline|"Participants who signed informed consent and were screened but did not meet study inclusion/exclusion criteria.
Participants in the screen fail group were not randomized to either Ketamine nor placebo and did not receive any infusions."
126471|NCT01667926|P2|Participant Flow|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.
Placebo"
126472|NCT01667926|P1|Participant Flow|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.
Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
126473|NCT01667926|O2|Outcome|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.
Placebo"
126474|NCT01667926|O1|Outcome|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.
Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
126475|NCT01667926|O2|Outcome|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.
Placebo"
126476|NCT01667926|O1|Outcome|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.
Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
126477|NCT01667926|E2|Reported Event|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.
Placebo"
126478|NCT01667926|E1|Reported Event|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.
Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
126479|NCT01667900|B6|Baseline|Total|Total of all reporting groups
126480|NCT01667900|B5|Baseline|Placebo (Part B-T2DM)|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126481|NCT01667900|B4|Baseline|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126482|NCT01667900|B3|Baseline|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126483|NCT01667900|B2|Baseline|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126509|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126484|NCT01667900|B1|Baseline|Part A-Healthy|Part A (single-dose, 3 treatment period, crossover design) involved overtly healthy participants only. Each participant received single doses of placebo and 2 of the 3 dulaglutide doses (0.5, 0.75, and 1.5 mg), in 3 treatment periods, such that placebo was administered SQ to all 16 participants and 0.5, 0.75, and 1.5 mg dulaglutide was administered SQ to 10, 11, and 11 participants, respectively. There was a washout period of at least 28 days between doses.
126485|NCT01667900|P20|Participant Flow|Placebo (Part B-T2DM)|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126486|NCT01667900|P19|Participant Flow|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126487|NCT01667900|P18|Participant Flow|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126488|NCT01667900|P17|Participant Flow|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks in Part B
126489|NCT01667900|P16|Participant Flow|First Placebo, Then 1.5 mg, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: 0.5 mg dulaglutide administered once SQ"
128529|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
126490|NCT01667900|P15|Participant Flow|First 1.5 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 1.5 mg dulaglutide administered once SQ
Period 2: 0.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ"
126491|NCT01667900|P14|Participant Flow|First Placebo, Then 1.5 mg, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: 0.75 mg dulaglutide administered once SQ"
126492|NCT01667900|P13|Participant Flow|First 0.75 mg, Then Placebo, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 0.5 mg dulaglutide administered once SQ"
126493|NCT01667900|P12|Participant Flow|First 0.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 0.75 mg dulaglutide administered once SQ"
126494|NCT01667900|P11|Participant Flow|First 1.5 mg, Then 0.75 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 1.5 mg dulaglutide administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ"
126495|NCT01667900|P10|Participant Flow|First 0.5 mg, Then 0.75 mg, Then Placebo (Part A-Helathy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 mg dulaglutide administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ"
126496|NCT01667900|P9|Participant Flow|First Placebo, Then 0.75 mg, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ"
126497|NCT01667900|P8|Participant Flow|First Placebo, Then 0.75 mg, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: 0.5 mg dulaglutide administered once SQ"
126498|NCT01667900|P7|Participant Flow|First 0.75 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ"
126499|NCT01667900|P6|Participant Flow|First Placebo, Then 0.5 mg, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 0.5 mg dulaglutide administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ"
126500|NCT01667900|P5|Participant Flow|First 1.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 1.5 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 0.75 mg dulaglutide administered once SQ"
126501|NCT01667900|P4|Participant Flow|First 0.5 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 mg dulaglutide administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ"
126502|NCT01667900|P3|Participant Flow|First 0.75 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ"
126503|NCT01667900|P2|Participant Flow|First 0.75 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: 0.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ"
126504|NCT01667900|P1|Participant Flow|First 0.5 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ)
Period 2: placebo administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ"
126516|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126517|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126518|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
126519|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
126520|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
126521|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126522|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126523|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126524|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
136568|NCT01627002|O3|Outcome|Part A PA401 1.0 mg|
126527|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126528|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126529|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
126530|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
126531|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
126532|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
126533|NCT01667900|E8|Reported Event|1.5 mg Dulaglutide (Part B-T2DM)|"1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
126534|NCT01667900|E7|Reported Event|0.75 mg Dulaglutide (Part B-T2DM)|"0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
126535|NCT01667900|E6|Reported Event|0.5 mg Dulaglutide (Part B-T2DM)|"0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
126536|NCT01667900|E5|Reported Event|Placebo (Part B-T2DM)|"Placebo administered to participants with T2DM once weekly SQ for 4 weeks
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
126537|NCT01667900|E4|Reported Event|1.5 mg Dulaglutide (Part A-Healthy)|"1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
126538|NCT01667900|E3|Reported Event|0.75 mg Dulaglutide (Part A-Healthy)|"0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
126539|NCT01667900|E2|Reported Event|0.5 mg Dulaglutide (Part A-Healthy)|"0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
126540|NCT01667900|E1|Reported Event|Placebo (Part A-Healthy)|"Placebo administered once SQ to healthy participants in 1 of 3 treatment periods
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
126541|NCT01667848|B3|Baseline|Total|Total of all reporting groups
126542|NCT01667848|B2|Baseline|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
126543|NCT01667848|B1|Baseline|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
126544|NCT01667848|P2|Participant Flow|Group B: Insufflation With Warm Gas|Insufflation with warm gas during laparoscopic cholecystectomy
126545|NCT01667848|P1|Participant Flow|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
126546|NCT01667848|O2|Outcome|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
126547|NCT01667848|O1|Outcome|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
126548|NCT01667848|O2|Outcome|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
126549|NCT01667848|O1|Outcome|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
126550|NCT01667848|E2|Reported Event|Group B|Insufflation with warm gas during laparoscopic cholecystectomy
126551|NCT01667848|E1|Reported Event|Group A|Insufflation with cold gas during laparoscopic cholecystectomy
126552|NCT01667796|B3|Baseline|Total|Total of all reporting groups
126553|NCT01667796|B2|Baseline|Healthy Controls|Female subjects without MS
126554|NCT01667796|B1|Baseline|MS Subjects|Female subjects with MS
126555|NCT01667796|P2|Participant Flow|Healthy Controls|Healthy control subjects
126556|NCT01667796|P1|Participant Flow|MS Subjects|MS patients
126557|NCT01667796|O2|Outcome|Healthy Controls|Female subjects without MS
126558|NCT01667796|O1|Outcome|MS Subjects|Female subjects with MS
126559|NCT01667796|E2|Reported Event|Healthy Controls|Healthy control subjects
126560|NCT01667796|E1|Reported Event|MS Subjects|MS patients
126562|NCT01667731|B5|Baseline|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126563|NCT01667731|B4|Baseline|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
126564|NCT01667731|B3|Baseline|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
126565|NCT01667731|B2|Baseline|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
126566|NCT01667731|B1|Baseline|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
126567|NCT01667731|P5|Participant Flow|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126568|NCT01667731|P4|Participant Flow|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
126569|NCT01667731|P3|Participant Flow|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced (TE), genotype 2)
126570|NCT01667731|P2|Participant Flow|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
126571|NCT01667731|P1|Participant Flow|SOF+RBV 12 Wk GT 2 TN|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN), genotype (GT) 2)
126572|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126573|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
126574|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
126575|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
126576|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
126577|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126578|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
126579|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
126580|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
126581|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
126582|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126583|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
126584|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
126585|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
126586|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
126587|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126588|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
126589|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
126590|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
126591|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
126592|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126593|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
126594|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
126595|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
126596|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
126597|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126598|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
126599|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
126676|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
126600|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
126601|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
126602|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126603|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
126604|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
126605|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
126606|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
126607|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126608|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
126609|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
126610|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
126611|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
126612|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126613|NCT01667731|O2|Outcome|SOF+RBV 24 Wk GT 2/3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
126614|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2/3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
126615|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126616|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
126617|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
126618|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
126619|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
126620|NCT01667731|E3|Reported Event|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
126621|NCT01667731|E2|Reported Event|SOF+RBV 24 Wk GT 2/3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
126622|NCT01667731|E1|Reported Event|SOF+RBV 12 Wk GT 2/3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
126623|NCT01667679|B3|Baseline|Total|Total of all reporting groups
126624|NCT01667679|B2|Baseline|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally.
126625|NCT01667679|B1|Baseline|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril.
126626|NCT01667679|P2|Participant Flow|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126627|NCT01667679|P1|Participant Flow|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period (TP) 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126667|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
126628|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126629|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126684|NCT01667536|B1|Baseline|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
126774|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126630|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126631|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126632|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126633|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126634|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126635|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126636|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126668|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
126669|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
126670|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
126637|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126638|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126639|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126640|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126641|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126642|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126643|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126644|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126645|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126671|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
126672|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
126712|NCT01667432|P1|Participant Flow|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
126646|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126647|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126648|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126649|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126650|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126651|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126652|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126653|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126654|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126673|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
126674|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
126675|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
126655|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126656|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126657|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126658|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126659|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126660|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126661|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126662|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126663|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
126664|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
126665|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
126666|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
126677|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
126678|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
126679|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
126680|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
126681|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
126682|NCT01667679|E2|Reported Event|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
126683|NCT01667679|E1|Reported Event|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
136569|NCT01627002|O2|Outcome|Part A PA401 0.3 mg|
126685|NCT01667536|P1|Participant Flow|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
126686|NCT01667536|O2|Outcome|Drug: 99mTc-MIP-1404 + MRI|Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
126687|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging."
126688|NCT01667536|O2|Outcome|Drug: 99mTc-MIP-1404 + MRI|Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
126689|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging."
126690|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
126691|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404 Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
126692|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
126693|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
126694|NCT01667536|E1|Reported Event|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
126695|NCT01667471|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126696|NCT01667471|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg intravenously (IV) every 4 weeks up to 104 weeks or until tocilizumab was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA).
126697|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126698|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126699|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126700|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126701|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126702|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126703|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126704|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126705|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126706|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126707|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126708|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126709|NCT01667471|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126710|NCT01667471|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
126711|NCT01667432|B1|Baseline|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
128305|NCT01660321|P1|Participant Flow|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
126713|NCT01667432|O1|Outcome|Peginterferon Alfa-2a|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
126714|NCT01667432|O1|Outcome|Peginterferon Alfa-2a|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
126715|NCT01667432|E1|Reported Event|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
126716|NCT01667224|B3|Baseline|Total|Total of all reporting groups
126717|NCT01667224|B2|Baseline|Placebo|"Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin."
126718|NCT01667224|B1|Baseline|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
126719|NCT01667224|P2|Participant Flow|Placebo|"Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin."
126770|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126771|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126720|NCT01667224|P1|Participant Flow|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
126721|NCT01667224|O2|Outcome|Placebo (450mg/Day) for 12 Week|Placebo: Amount and calorie of placebo are same with Actiponin
126722|NCT01667224|O1|Outcome|Actiponin(450mg/Day) for 12week|Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.
126723|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin."
126724|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
126725|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin."
126726|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
126727|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin."
126728|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
126729|NCT01667224|E2|Reported Event|Placebo|"Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin."
126730|NCT01667224|E1|Reported Event|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
126731|NCT01667107|B3|Baseline|Total|Total of all reporting groups
126732|NCT01667107|B2|Baseline|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126733|NCT01667107|B1|Baseline|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126734|NCT01667107|P2|Participant Flow|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126735|NCT01667107|P1|Participant Flow|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126736|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126737|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126762|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126738|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126739|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126772|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126773|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
136570|NCT01627002|O1|Outcome|Part A PA401 0.1 mg|
126740|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126741|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126742|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126743|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126744|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126745|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126746|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126747|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126748|NCT01667107|E2|Reported Event|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126749|NCT01667107|E1|Reported Event|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
126750|NCT01666951|B3|Baseline|Total|Total of all reporting groups
126751|NCT01666951|B2|Baseline|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126752|NCT01666951|B1|Baseline|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126753|NCT01666951|P2|Participant Flow|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126754|NCT01666951|P1|Participant Flow|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126755|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126756|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126757|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126758|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126759|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126760|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126761|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
128843|NCT01658514|E1|Reported Event|Placebo|One dose of Placebo
126764|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126765|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126766|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126767|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126768|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126769|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126775|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126776|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126777|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126778|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126779|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126780|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126781|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126782|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126783|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126784|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126785|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126786|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126787|NCT01666951|E2|Reported Event|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus"
126788|NCT01666951|E1|Reported Event|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus"
126789|NCT01666912|B3|Baseline|Total|Total of all reporting groups
126790|NCT01666912|B2|Baseline|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum
Contraceptive implant"
126791|NCT01666912|B1|Baseline|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit
Contraceptive implant"
126792|NCT01666912|P2|Participant Flow|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum
Contraceptive implant"
126793|NCT01666912|P1|Participant Flow|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit
Contraceptive implant"
126794|NCT01666912|O2|Outcome|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum
Contraceptive implant"
126795|NCT01666912|O1|Outcome|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit
Contraceptive implant"
126796|NCT01666912|O2|Outcome|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum
Contraceptive implant"
126797|NCT01666912|O1|Outcome|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit
Contraceptive implant"
126798|NCT01666912|O2|Outcome|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum
Contraceptive implant"
126799|NCT01666912|O1|Outcome|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit
Contraceptive implant"
126800|NCT01666912|E2|Reported Event|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum
Contraceptive implant"
126801|NCT01666912|E1|Reported Event|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit
Contraceptive implant"
126802|NCT01666782|B3|Baseline|Total|Total of all reporting groups
126803|NCT01666782|B2|Baseline|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
126804|NCT01666782|B1|Baseline|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
126805|NCT01666782|P2|Participant Flow|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
126832|NCT01666210|E2|Reported Event|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
126806|NCT01666782|P1|Participant Flow|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
126807|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
126808|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
126809|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
126810|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
126811|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
126812|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
126813|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
126814|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
126815|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
126816|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
126817|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
126818|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
126819|NCT01666782|E2|Reported Event|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
126820|NCT01666782|E1|Reported Event|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
126821|NCT01666210|B3|Baseline|Total|Total of all reporting groups
126822|NCT01666210|B2|Baseline|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
126823|NCT01666210|B1|Baseline|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
126824|NCT01666210|P2|Participant Flow|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
126825|NCT01666210|P1|Participant Flow|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
126826|NCT01666210|O2|Outcome|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
126827|NCT01666210|O1|Outcome|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
126828|NCT01666210|O2|Outcome|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
126829|NCT01666210|O1|Outcome|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
126830|NCT01666210|O2|Outcome|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
126831|NCT01666210|O1|Outcome|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
126833|NCT01666210|E1|Reported Event|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
126834|NCT01666197|B3|Baseline|Total|Total of all reporting groups
126835|NCT01666197|B2|Baseline|Placebo|placebo: placebo
126836|NCT01666197|B1|Baseline|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
126837|NCT01666197|P2|Participant Flow|Placebo|placebo: placebo
126838|NCT01666197|P1|Participant Flow|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
126839|NCT01666197|O2|Outcome|Placebo|placebo: placebo
126840|NCT01666197|O1|Outcome|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
126841|NCT01666197|E2|Reported Event|Placebo|placebo: placebo
126842|NCT01666197|E1|Reported Event|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
126843|NCT01666119|B1|Baseline|BEMA Buprenorphine NX Films|"BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.
BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively."
126844|NCT01666119|P1|Participant Flow|BEMA Buprenorphine NX Films|"BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg).
BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg)."
126845|NCT01666119|O1|Outcome|BEMA Buprenorphine/NX Films|BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)
126846|NCT01666119|O1|Outcome|BEMA Buprenorphine/NX Films|BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)
126847|NCT01666119|E1|Reported Event|BEMA Buprenorphine NX Films|"BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.
BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively."
126848|NCT01666002|B3|Baseline|Total|Total of all reporting groups
126849|NCT01666002|B2|Baseline|Placebo|"st visit: For the control group, no treatment will be given.
nd visit: 2 weeks after initial visit, patient will be seen for second visit"
126850|NCT01666002|B1|Baseline|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser"
126851|NCT01666002|P2|Participant Flow|Placebo|"st visit: For the control group, no treatment will be given.
nd visit: 2 weeks after initial visit, patient will be seen for second visit"
126852|NCT01666002|P1|Participant Flow|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
42 patients were assessed and 27 met eligibility criteria of a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture."
126853|NCT01666002|O2|Outcome|Placebo|"st visit: For the control group, no treatment will be given.
nd visit: 2 weeks after initial visit, patient will be seen for second visit"
126854|NCT01666002|O1|Outcome|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser"
126855|NCT01666002|O2|Outcome|Placebo|"st visit: For the control group, no treatment will be given.
nd visit: 2 weeks after initial visit, patient will be seen for second visit"
126856|NCT01666002|O1|Outcome|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
After 3 months, 4 of 12 patients (33%) in the laser group had negative fungal cultures. Of the 4 patients in the laser group with baseline cultures positive for a non-dermatophyte mold, 2 (50%) had negative fungal cultures. After 3 months of observation, 2 of 10 (20%) control subjects had negative cultures. Of the 3 patients in the control group with baseline cultures positive for a non-dermatophyte mold, 1 (33%) had a negative fungal culture. There was no significant difference in the percentage of patients with negative nail cultures between laser versus control groups (P = .49)."
126857|NCT01666002|E2|Reported Event|Placebo|"st visit: For the control group, no treatment will be given.
nd visit: 2 weeks after initial visit, patient will be seen for second visit"
126858|NCT01666002|E1|Reported Event|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
No patients reported complications or adverse events after 2 sessions."
126859|NCT01665950|B4|Baseline|Total|Total of all reporting groups
126860|NCT01665950|B3|Baseline|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks
Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
126887|NCT01665807|O1|Outcome|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)
Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
127218|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
126861|NCT01665950|B2|Baseline|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks
Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.
Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
126862|NCT01665950|B1|Baseline|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)
Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
126863|NCT01665950|P3|Participant Flow|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks
Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
126864|NCT01665950|P2|Participant Flow|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks
Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.
Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
126865|NCT01665950|P1|Participant Flow|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)
Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
126866|NCT01665950|O3|Outcome|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks
Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
126867|NCT01665950|O2|Outcome|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks
Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.
Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
126868|NCT01665950|O1|Outcome|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)
Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
126869|NCT01665950|E3|Reported Event|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks
Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
126888|NCT01665807|O3|Outcome|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
126889|NCT01665807|O2|Outcome|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
126890|NCT01665807|O1|Outcome|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)
Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
126870|NCT01665950|E2|Reported Event|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks
Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.
Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
126871|NCT01665950|E1|Reported Event|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)
Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
126872|NCT01665911|B1|Baseline|All Participants|"1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.
1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.
3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.
3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design
Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design"
126873|NCT01665911|P1|Participant Flow|All Participants|"Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:
. 1.5 mg Sodium Fluoride in 100 ml milk: .
1.5 mg Sodium Fluoride in 200 ml milk
3.0 mg Sodium Fluoride in 100 ml milk
3.0 mg Sodium Fluoride in 200 ml milk
0 mg fluoride in 200 ml milk"
126874|NCT01665911|O1|Outcome|All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml
Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use."
126875|NCT01665911|O1|Outcome|All Participants|"Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:
. 1.5 mg Sodium Fluoride in 100 ml milk: .
1.5 mg Sodium Fluoride in 200 ml milk
3.0 mg Sodium Fluoride in 100 ml milk
3.0 mg Sodium Fluoride in 200 ml milk
0 mg fluoride in 200 ml milk"
126876|NCT01665911|O1|Outcome|All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml
Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use."
126877|NCT01665911|E1|Reported Event|Arm/Group All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml
1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.
1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.
3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.
3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design
Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design."
126878|NCT01665807|B4|Baseline|Total|Total of all reporting groups
126879|NCT01665807|B3|Baseline|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
126880|NCT01665807|B2|Baseline|Repeat Self-administered Intradermal|"Self-administration (2) of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
126881|NCT01665807|B1|Baseline|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)
Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
126882|NCT01665807|P3|Participant Flow|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
126883|NCT01665807|P2|Participant Flow|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
126884|NCT01665807|P1|Participant Flow|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)
Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
126885|NCT01665807|O3|Outcome|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
126886|NCT01665807|O2|Outcome|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
126891|NCT01665807|E3|Reported Event|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
126892|NCT01665807|E2|Reported Event|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
126893|NCT01665807|E1|Reported Event|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)
Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
126894|NCT01665508|B1|Baseline|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.
Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
126895|NCT01665508|P1|Participant Flow|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.
Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
126896|NCT01665508|O2|Outcome|Baseline|results without nebivolol
126897|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.
Nebivolol: Patient to start nebivolol and have repeat testing in 3 months
this data was incomplete and not useful for analysis"
126898|NCT01665508|O2|Outcome|Baseline|results prior to nebivolol start
126899|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.
Nebivolol: Patient to start nebivolol and have repeat testing in 3 months
There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)"
126900|NCT01665508|O2|Outcome|Baseline|results without nebivolol
126901|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.
Nebivolol: Patient to start nebivolol and have repeat testing in 3 months
this data was incomplete and not useful for analysis"
126902|NCT01665508|O2|Outcome|Baseline|results off nebivolol
126903|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.
Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
126904|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.
Nebivolol: Patient to start nebivolol and have repeat testing in 3 months
this data was incomplete and not useful for analysis"
126905|NCT01665508|O2|Outcome|Baseline|results off nebivolol
126906|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.
Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
126907|NCT01665508|O2|Outcome|Baseline|results prior to nebivolol start
126908|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.
Nebivolol: Patient to start nebivolol and have repeat testing in 3 months
There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)"
126909|NCT01665508|E1|Reported Event|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.
Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
126910|NCT01665170|B3|Baseline|Total|Total of all reporting groups
126911|NCT01665170|B2|Baseline|Verum|Verum arm - Pascoflair 425mg
126912|NCT01665170|B1|Baseline|Placebo|Placebo arm
126913|NCT01665170|P2|Participant Flow|Verum|Verum arm - Pascoflair 425mg, 3 x 1 tablet per every day for 3 days
126914|NCT01665170|P1|Participant Flow|Placebo|Placebo arm, 3 x 1 tablet per every day for 3 days
126915|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
126916|NCT01665170|O1|Outcome|Placebo|Placebo arm
126917|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
126918|NCT01665170|O1|Outcome|Placebo|Placebo arm
126919|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
126920|NCT01665170|O1|Outcome|Placebo|Placebo arm
126921|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
126922|NCT01665170|O1|Outcome|Placebo|Placebo arm
126923|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
126924|NCT01665170|O1|Outcome|Placebo|Placebo arm
126925|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
126926|NCT01665170|O1|Outcome|Placebo|Placebo arm
126927|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
126928|NCT01665170|O1|Outcome|Placebo|Placebo arm
126929|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
126930|NCT01665170|O1|Outcome|Placebo|Placebo arm
126931|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
126932|NCT01665170|O1|Outcome|Placebo|Placebo arm
126962|NCT01665157|B3|Baseline|Low-residue Diet (Enimaclin®) Package and 1.5L PEG|Low-residue diet package with normal amount of 1.5L PEG-ELS
126963|NCT01665157|B2|Baseline|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount of 2L PEG-ELS
126964|NCT01665157|B1|Baseline|Low-residue Diet Package (Enimaclin®) and 2L PEG|Low-residue diet package with normal amount of 2L PEG-ELS
126965|NCT01665157|P3|Participant Flow|Low-residue Diet Package and 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
126966|NCT01665157|P2|Participant Flow|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
126967|NCT01665157|P1|Participant Flow|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
126968|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
126969|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
126970|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
126971|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with reduced volume 1.5L PEG-ELS
126972|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with 2L PEG-ELS
126973|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
126974|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5 L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
126975|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
126976|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
126977|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
126978|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
126979|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
126980|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
126981|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
126982|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
126983|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with reduced volume low volume 1.5L PEG-ELS
126984|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
126985|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
126986|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
126987|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
126988|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
126989|NCT01665157|E3|Reported Event|Low-residue Diet Package Plus 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
126990|NCT01665157|E2|Reported Event|Self-controlled Diet|Self-controlled diet with normal amount 2L PEG-ELS
126991|NCT01665157|E1|Reported Event|Low-residue Diet Package|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
126992|NCT01665053|B3|Baseline|Total|Total of all reporting groups
126993|NCT01665053|B2|Baseline|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
126994|NCT01665053|B1|Baseline|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
126995|NCT01665053|P2|Participant Flow|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
126996|NCT01665053|P1|Participant Flow|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
126997|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
126998|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
126999|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127000|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127044|NCT01664949|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
128920|NCT01657461|B2|Baseline|IV t-PA|IV infusion of tPA
127001|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127002|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127003|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127004|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127005|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127006|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127007|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127008|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127009|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127010|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127011|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127012|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127013|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127014|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127015|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127016|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127017|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127018|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127019|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127020|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127021|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127045|NCT01664949|P2|Participant Flow|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127022|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127023|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127024|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127025|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127026|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127027|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127028|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127029|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127030|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127031|NCT01665053|E2|Reported Event|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system"
127032|NCT01665053|E1|Reported Event|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system"
127033|NCT01664975|B3|Baseline|Total|Total of all reporting groups
127034|NCT01664975|B2|Baseline|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen
CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
127035|NCT01664975|B1|Baseline|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen
GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
127036|NCT01664975|P2|Participant Flow|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen
CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
127037|NCT01664975|P1|Participant Flow|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen
GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
127038|NCT01664975|O2|Outcome|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen
CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
127039|NCT01664975|O1|Outcome|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen
GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
127040|NCT01664975|E2|Reported Event|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen
CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
127041|NCT01664975|E1|Reported Event|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen
GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
127042|NCT01664949|B3|Baseline|Total|Total of all reporting groups
127043|NCT01664949|B2|Baseline|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
128306|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
127046|NCT01664949|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127047|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127048|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127049|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127050|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127051|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127052|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127053|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
136571|NCT01627002|O9|Outcome|Part B Placebo|
127054|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127055|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127056|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127057|NCT01664949|E2|Reported Event|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127058|NCT01664949|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
127059|NCT01664923|B3|Baseline|Total|Total of all reporting groups
127060|NCT01664923|B2|Baseline|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
127061|NCT01664923|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
127062|NCT01664923|P2|Participant Flow|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
127063|NCT01664923|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
127064|NCT01664923|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
127065|NCT01664923|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
127066|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
127067|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
127068|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
127069|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
127070|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
127071|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
127072|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
127073|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
127074|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
127075|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
127076|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
127077|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
127078|NCT01664923|E2|Reported Event|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
127079|NCT01664923|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
127080|NCT01664806|B3|Baseline|Total|Total of all reporting groups
127081|NCT01664806|B2|Baseline|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.
Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
127112|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
127082|NCT01664806|B1|Baseline|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.
Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
127083|NCT01664806|P2|Participant Flow|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.
Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
127084|NCT01664806|P1|Participant Flow|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.
Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
127085|NCT01664806|O2|Outcome|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.
Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
127122|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
127086|NCT01664806|O1|Outcome|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.
Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
127087|NCT01664806|O2|Outcome|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.
Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
127088|NCT01664806|O1|Outcome|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.
Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
127089|NCT01664806|E2|Reported Event|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.
Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
127090|NCT01664806|E1|Reported Event|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.
Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
127091|NCT01664793|B3|Baseline|Total|Total of all reporting groups
127092|NCT01664793|B2|Baseline|Control Group|Children in 10 diverse pediatric and family practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
127093|NCT01664793|B1|Baseline|Intervention Group|Children in 10 diverse pediatric and family medicine practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
127094|NCT01664793|P2|Participant Flow|Control Group|Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the control group; n=38,626. They will receive the 4 Pillars Toolkit and early season vaccine in Year 2.
127095|NCT01664793|P1|Participant Flow|Intervention Group|"Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the Intervention group; n=49,039.
Intervention sites will use the 4 Pillars toolkit along with early season vaccine to promote increases in childhood influenza vaccination."
127096|NCT01664793|O2|Outcome|Control Group|This group did not rate effectiveness of the intervention.
127097|NCT01664793|O1|Outcome|Intervention Group|2 respondents in each of 10 diverse pediatric and family medicine practices.
127098|NCT01664793|O2|Outcome|Control Group|Children with a visit between 3/1/2011 and 2/29/2012 in 10 diverse pediatric and family practices.
127099|NCT01664793|O1|Outcome|Intervention Group|Children seen in 10 diverse pediatric and family medicine practices between 3/1/2011 and 2/29/2012.
127100|NCT01664793|E2|Reported Event|Control Group|Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.
127101|NCT01664793|E1|Reported Event|Intervention Group|Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.
127102|NCT01664624|B5|Baseline|Total|Total of all reporting groups
127103|NCT01664624|B4|Baseline|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
127104|NCT01664624|B3|Baseline|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
127105|NCT01664624|B2|Baseline|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
127106|NCT01664624|B1|Baseline|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
127107|NCT01664624|P4|Participant Flow|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
127108|NCT01664624|P3|Participant Flow|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
127109|NCT01664624|P2|Participant Flow|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
127110|NCT01664624|P1|Participant Flow|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
127111|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
127113|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
127114|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
127115|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
127116|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
127117|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
127118|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
127119|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
127120|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
127121|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
127123|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
127124|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
127125|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
127126|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
127127|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
127128|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
127129|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
127130|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
127131|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
127132|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
127133|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
127134|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
127135|NCT01664624|E4|Reported Event|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
127136|NCT01664624|E3|Reported Event|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
127137|NCT01664624|E2|Reported Event|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
127138|NCT01664624|E1|Reported Event|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
127139|NCT01664559|B3|Baseline|Total|Total of all reporting groups
127140|NCT01664559|B2|Baseline|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
127141|NCT01664559|B1|Baseline|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
127142|NCT01664559|P2|Participant Flow|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
127143|NCT01664559|P1|Participant Flow|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
127144|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
127145|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
127146|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
127147|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
127148|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
127149|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
127150|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
127151|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
128307|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
127152|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
127153|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
127154|NCT01664559|E2|Reported Event|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
127155|NCT01664559|E1|Reported Event|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
127156|NCT01664533|B1|Baseline|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
127157|NCT01664533|P1|Participant Flow|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
127158|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
127159|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
127160|NCT01664533|O1|Outcome|Erlotinib|"Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Erlotinib: Erlotinib was supplied as tablets in the retail product Tarceva."
127161|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
127162|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
127163|NCT01664533|E1|Reported Event|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
127164|NCT01664494|B1|Baseline|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
127165|NCT01664494|P1|Participant Flow|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
127166|NCT01664494|O1|Outcome|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
127167|NCT01664494|O1|Outcome|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
127168|NCT01664494|E1|Reported Event|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
127169|NCT01664247|B3|Baseline|Total|Total of all reporting groups
127170|NCT01664247|B2|Baseline|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127171|NCT01664247|B1|Baseline|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127172|NCT01664247|P2|Participant Flow|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127173|NCT01664247|P1|Participant Flow|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
135596|NCT01631825|B1|Baseline|SPM 962|SPM 962 transdermal patch
127174|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127175|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127176|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127177|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127178|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127179|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127180|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127181|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127182|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127183|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127184|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127185|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127186|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
135597|NCT01631825|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
127187|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127188|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127227|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127228|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127229|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127189|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127190|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127191|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127192|NCT01664247|E2|Reported Event|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127193|NCT01664247|E1|Reported Event|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
127194|NCT01664117|B1|Baseline|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
127195|NCT01664117|P1|Participant Flow|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
127196|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127197|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127198|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
127199|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
127200|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
127201|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
127202|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
127203|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
127204|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
127205|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
127206|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127207|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127208|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127209|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127210|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127211|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127212|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127213|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127214|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127215|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127216|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127217|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
136712|NCT01626118|O4|Outcome|Placebo|Placebo Group
127219|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127220|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127221|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127222|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127223|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127224|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127225|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127226|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127230|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127231|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127232|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
127233|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127234|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127235|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127236|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127237|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127238|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127239|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127240|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127241|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127242|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127243|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127244|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127245|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127246|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127247|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127248|NCT01664117|E1|Reported Event|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
127249|NCT01664104|B1|Baseline|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127250|NCT01664104|P1|Participant Flow|Rheumatoid Arthritis (RA) Participants|Participants with moderate or severe RA who were under tocilizumab (TCZ) treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127251|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127252|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127253|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127254|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127255|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127256|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127257|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127258|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127259|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA were prescribed with tocilizumab, in accordance with routine clinic practice, and following the local label were observed for 6 months with maximum study duration of 18 months.
127260|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127261|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
128308|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
127262|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127263|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127264|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127265|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127266|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127267|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127268|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127269|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127270|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127271|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127272|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127273|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127274|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127275|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127276|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127277|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127278|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127279|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127280|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127281|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127282|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127283|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127284|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127285|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127286|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127287|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127288|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127289|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127290|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127291|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
136944|NCT01624350|O3|Outcome|Permacol Collagen Paste - 6 Month Post-op|
127292|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127293|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were prescribed with tocilizumab, in accordance with routine clinic practice, and following the local label were observed for 6 months with maximum study duration of 18 months.
127294|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127295|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127296|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127378|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127297|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127298|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127299|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127300|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA were prescribed with tocilizumab, in accordance with routine clinic practice, and following the local label were observed for 6 months with maximum study duration of 18 months.
127301|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127302|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127303|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127304|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127305|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127306|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127307|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127308|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127309|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127310|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127311|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127312|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127313|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127314|NCT01664104|O1|Outcome|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127315|NCT01664104|E1|Reported Event|RA Participants|Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
127316|NCT01664052|B3|Baseline|Total|Total of all reporting groups
127317|NCT01664052|B2|Baseline|ESS305/ESS505|Unilateral placement of Essure 505 (BAY1454033) insert (PET-inclusive) and Contralateral placement of the current commercial Essure device Essure 305 (BAY1454032)
127318|NCT01664052|B1|Baseline|ESS505-A|Bilateral placement of Essure 505A (BAY1454033) insert (with minimal PET fiber).
127319|NCT01664052|P2|Participant Flow|ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
127370|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127805|NCT01662583|B2|Baseline|Plain Text Message|"plain text message reminder
Text Message
Written reminder"
127320|NCT01664052|P1|Participant Flow|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
127321|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
127322|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
127323|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
127324|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
127325|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
127326|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
127327|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
127328|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
127329|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
127330|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
127806|NCT01662583|B1|Baseline|Educational Text Message|"Educational text message reminder
Text Message
Written reminder"
127331|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
127332|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
127333|NCT01664052|E2|Reported Event|ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
127334|NCT01664052|E1|Reported Event|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
127335|NCT01664039|B3|Baseline|Total|Total of all reporting groups
127336|NCT01664039|B2|Baseline|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
127337|NCT01664039|B1|Baseline|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
127338|NCT01664039|P2|Participant Flow|LUMIGAN|One drop to the study eye(s) once a day in the evening, for 6 months
127339|NCT01664039|P1|Participant Flow|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
127340|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
127341|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
127342|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
127343|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
127344|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
127345|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
127346|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
127347|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
127348|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
127349|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
127350|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
127351|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
127352|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
127353|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
127354|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
127355|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
127356|NCT01664039|E2|Reported Event|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
127357|NCT01664039|E1|Reported Event|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
127358|NCT01663987|B3|Baseline|Total|Total of all reporting groups
127359|NCT01663987|B2|Baseline|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127360|NCT01663987|B1|Baseline|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127361|NCT01663987|P2|Participant Flow|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127362|NCT01663987|P1|Participant Flow|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127363|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127364|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127365|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127366|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127367|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127368|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127369|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
136945|NCT01624350|O2|Outcome|Permacol Collagen Paste - 3 Month Post-op|
127371|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127372|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127373|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127374|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127375|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127376|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127377|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127379|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127380|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127381|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127382|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127383|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127384|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127385|NCT01663987|E2|Reported Event|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127386|NCT01663987|E1|Reported Event|Placebo|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127387|NCT01663922|B1|Baseline|All Participants|Descriptive analysis of combined groups
127388|NCT01663922|P2|Participant Flow|Group B (Boceprevir Then St John's Wort)|"Boceprevir for 5 days (10-14)
[wash out for 7 days (15-21)]
SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)
[wash out for 7 days (36-42)
SJW from day 43 to day 56"
127389|NCT01663922|P1|Participant Flow|Group A (St John's Wort Then Boceprevir)|"St John’s Wort, (SJW) for 14 days (1-14)
[wash out for 7 days (15-21)]
SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)
[wash out for 7 days (36-42)]
boceprevir from day 52 to day 56"
127390|NCT01663922|O1|Outcome|All Participants|Combined analysis of both group sequences
127391|NCT01663922|E2|Reported Event|Group B|Boceprevir first
127392|NCT01663922|E1|Reported Event|Group A|St John's Wort first
127393|NCT01663779|B3|Baseline|Total|Total of all reporting groups
127394|NCT01663779|B2|Baseline|Palpation Based Artery Catheterization|"Blind insertion of radial artery catheterization
Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only."
127395|NCT01663779|B1|Baseline|Ultrasound Radial Artery Catheter|"Ultrasound guided radial artery catheterization.
Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound."
127396|NCT01663779|P2|Participant Flow|Palpation Based Artery Catheterization|"Blind insertion of radial artery catheterization
Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only."
127397|NCT01663779|P1|Participant Flow|Ultrasound Radial Artery Catheter|"Ultrasound guided radial artery catheterization.
Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound."
127398|NCT01663779|O2|Outcome|Palpation|palpation artery
127399|NCT01663779|O1|Outcome|Ultrasound|ultrasound atery
127400|NCT01663779|E2|Reported Event|Palpation|palpation artery
127401|NCT01663779|E1|Reported Event|Ultrasound|ultrasound artery
127402|NCT01663727|B3|Baseline|Total|Total of all reporting groups
127403|NCT01663727|B2|Baseline|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127404|NCT01663727|B1|Baseline|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127405|NCT01663727|P2|Participant Flow|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 milligram per kilogram (mg/kg) on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127406|NCT01663727|P1|Participant Flow|Paclitaxel+Placebo|Participants received paclitaxel 90 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127407|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127408|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127409|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127410|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127411|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127412|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127413|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127414|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127415|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
136572|NCT01627002|O8|Outcome|Part B PA401 3.0 mg|
127416|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127417|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127418|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127419|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127420|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127421|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127422|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127423|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127424|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127425|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127426|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127427|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127428|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127429|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127430|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127431|NCT01663727|E2|Reported Event|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127432|NCT01663727|E1|Reported Event|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
127433|NCT01663714|B1|Baseline|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127458|NCT01663714|E2|Reported Event|Period After Dosimetric and Therapeutic Dose|After receiving Cyclophosphamide, Vincristine, and Prednisone, par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose.
127434|NCT01663714|P1|Participant Flow|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemotherapy (chemo.): oral Cyclophosphamide (400 milligrams/meters squared [mg/m^2]/day) for 1-5 days; intravenous (IV) Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127580|NCT01662999|P4|Participant Flow|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|"Single dose of:
Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral"
127435|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127436|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127437|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127438|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127439|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127440|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127441|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127459|NCT01663714|E1|Reported Event|Period After CVP|Par. received 6 cycles of chemotherapy as follows: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; intravenous Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days
127460|NCT01663532|B3|Baseline|Total|Total of all reporting groups
127442|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127623|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
127443|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127444|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127445|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127446|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127447|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127448|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127449|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127461|NCT01663532|B2|Baseline|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
127578|NCT01662999|P6|Participant Flow|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|"Single dose of:
Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet"
127450|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127451|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127452|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127453|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127454|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127455|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127456|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127457|NCT01663714|E3|Reported Event|Combined Regimen Period|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
127500|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127665|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127462|NCT01663532|B1|Baseline|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
127463|NCT01663532|P2|Participant Flow|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
136573|NCT01627002|O7|Outcome|Part B PA401 1.0 mg|
127464|NCT01663532|P1|Participant Flow|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
127465|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
127466|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
127467|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
127468|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
127469|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
127470|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
127471|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
127472|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
127473|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
127474|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
127475|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
127476|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
127477|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
127478|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
127479|NCT01663532|E2|Reported Event|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
127802|NCT01662635|E1|Reported Event|Adverse Events Not Collected|"Serious and Other were not collected/assessed in this observational study."
127480|NCT01663532|E1|Reported Event|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
127624|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127481|NCT01663506|B1|Baseline|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127482|NCT01663506|P1|Participant Flow|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab (RoActemra/Actemra) treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127483|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127484|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127485|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127486|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127487|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127488|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127489|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127490|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127491|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127492|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127493|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127494|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127495|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127496|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127497|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127498|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127499|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127618|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127501|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127625|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
128530|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
127502|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127503|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127504|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127505|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127506|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127507|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127508|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127509|NCT01663506|E1|Reported Event|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
127510|NCT01663363|B1|Baseline|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
127511|NCT01663363|P1|Participant Flow|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
127512|NCT01663363|O1|Outcome|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
127513|NCT01663363|O1|Outcome|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
127514|NCT01663363|E1|Reported Event|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
127515|NCT01663285|B1|Baseline|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
127516|NCT01663285|P1|Participant Flow|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
127517|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
127518|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
127519|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
127520|NCT01663285|E1|Reported Event|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
127521|NCT01663233|B3|Baseline|Total|Total of all reporting groups
127522|NCT01663233|B2|Baseline|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127619|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single saxagliptin 5mg, Tablet, Oral.
127803|NCT01662583|B4|Baseline|Total|Total of all reporting groups
127523|NCT01663233|B1|Baseline|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127524|NCT01663233|P2|Participant Flow|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127525|NCT01663233|P1|Participant Flow|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127526|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127527|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127528|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127529|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127530|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127531|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127532|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127533|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127534|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127535|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127536|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127537|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127538|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127539|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127540|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127541|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127542|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127577|NCT01662999|B1|Baseline|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral.
127543|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127544|NCT01663233|E2|Reported Event|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
127545|NCT01663233|E1|Reported Event|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
127546|NCT01663103|B3|Baseline|Total|Total of all reporting groups
127547|NCT01663103|B2|Baseline|Placebo|"Twelve weeks of treatment with placebo
Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
127548|NCT01663103|B1|Baseline|Rilonacept|"12 weeks of treatment with rilonacept
Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
127549|NCT01663103|P2|Participant Flow|Placebo|"Twelve weeks of treatment with placebo
Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
127550|NCT01663103|P1|Participant Flow|Rilonacept|"12 weeks of treatment with rilonacept
Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
127551|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo
Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
127552|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept
Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
127553|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo
Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
127554|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept
Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
127555|NCT01663103|O4|Outcome|Placebo: End of Study|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline
127556|NCT01663103|O3|Outcome|Placebo: Baseline|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline
127557|NCT01663103|O2|Outcome|Rilonacept: End of Study|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at 12 weeks.
127558|NCT01663103|O1|Outcome|Rilonacept: Baseline|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at baseline.
127559|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo
Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
127560|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept
Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
127561|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo
Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
127562|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept
Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
127563|NCT01663103|E2|Reported Event|Placebo|"Twelve weeks of treatment with placebo
Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
127564|NCT01663103|E1|Reported Event|Rilonacept|"12 weeks of treatment with rilonacept
Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
127565|NCT01663012|B1|Baseline|Drug: Etirinotecan Pegol|"145 mg/m2 dose
Etirinotecan pegol"
127566|NCT01663012|P1|Participant Flow|Drug: Etirinotecan Pegol|"145 mg/m2 dose
Etirinotecan pegol"
127567|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose
Etirinotecan pegol"
127568|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose
Etirinotecan pegol"
127569|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose
Etirinotecan pegol"
127570|NCT01663012|E1|Reported Event|Drug: Etirinotecan Pegol|"145 mg/m2 dose
Etirinotecan pegol"
127571|NCT01662999|B7|Baseline|Total|Total of all reporting groups
127572|NCT01662999|B6|Baseline|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
127573|NCT01662999|B5|Baseline|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets,Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
127574|NCT01662999|B4|Baseline|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
127575|NCT01662999|B3|Baseline|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral
127576|NCT01662999|B2|Baseline|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
127664|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127579|NCT01662999|P5|Participant Flow|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|"Single dose of:
Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral"
128531|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
127581|NCT01662999|P3|Participant Flow|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|"Single dose of:
Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral"
127582|NCT01662999|P2|Participant Flow|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|"Single dose of:
Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral"
127583|NCT01662999|P1|Participant Flow|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|"Single dose of:
Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral"
127584|NCT01662999|O6|Outcome|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
127585|NCT01662999|O5|Outcome|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets,Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
127586|NCT01662999|O4|Outcome|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
127587|NCT01662999|O3|Outcome|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral
127588|NCT01662999|O2|Outcome|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
127589|NCT01662999|O1|Outcome|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral.
127590|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
127591|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin
127592|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
127593|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127594|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin
127595|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
127596|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
127597|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
127598|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
127599|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
127600|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
127601|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
127602|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
127603|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
127604|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
127605|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
127606|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
127607|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
127608|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
127609|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|A single oral tablet dose of 10 mg Dapagliflozin.
127610|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
127611|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Treatment C: Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin..
127612|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Treatment B: A single oral tablet dose of 10 mg Dapagliflozin.
127613|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Treatment A: Single dose oral tablet of 5 mg saxagliptin..
127614|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127615|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
127616|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127617|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
136946|NCT01624350|O1|Outcome|Baseline - Pre-operatively|
127620|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127621|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
127622|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127626|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127627|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
127628|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127629|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: single dose of Saxagliptin 5mg, Tablet, Oral.
127630|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127631|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: single dose of Saxagliptin 5mg, Tablet, Oral.
127632|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127633|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
127634|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127635|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
127636|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127637|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose Saxagliptin 5mg, Tablet, Oral.
127638|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127639|NCT01662999|O1|Outcome|10mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin
127640|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127641|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
127642|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127643|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
127644|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127645|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
127646|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
127647|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin
127648|NCT01662999|E3|Reported Event|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, Once daily, 1 day in each of 3 periods.
127649|NCT01662999|E2|Reported Event|Treatment B: Dapagliflozin 10mg|Dapagliflozin 10mg, Tablet, Oral, Once daily, 1 day in each of 3 periods.
127650|NCT01662999|E1|Reported Event|Treatment A: Saxagliptin 5mg|Saxagliptin 5mg, Tablet, Oral, Once daily, 1 day in each of 3 periods.
127651|NCT01662986|B3|Baseline|Total|Total of all reporting groups
127652|NCT01662986|B2|Baseline|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127653|NCT01662986|B1|Baseline|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127654|NCT01662986|P2|Participant Flow|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127655|NCT01662986|P1|Participant Flow|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127656|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127657|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127658|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127659|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127660|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127661|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127662|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127663|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127666|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127667|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127668|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127669|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127670|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127671|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127672|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127673|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127674|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127675|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127676|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127677|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127678|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127679|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127680|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
127681|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
127682|NCT01662986|E2|Reported Event|Tiotropium Bromide (18 μg)|Patient to receive one tiotropium bromide inhalation powder capsule once daily in the morning via HandiHaler
127683|NCT01662986|E1|Reported Event|Placebo|Patient to receive one placebo inhalation powder capsule once daily in the morning via HandiHaler
127684|NCT01662908|B3|Baseline|Total|Total of all reporting groups
127685|NCT01662908|B2|Baseline|Warfarin|Participants treated with warfarin
127686|NCT01662908|B1|Baseline|Edoxaban|Participants treated with edoxaban
127687|NCT01662908|P2|Participant Flow|Warfarin|Participants treated with warfarin
127688|NCT01662908|P1|Participant Flow|Edoxaban|Participants treated with edoxaban
127689|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
127690|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
127691|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
127692|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
127693|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
127694|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
127695|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
127696|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
127697|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
127698|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
127699|NCT01662908|E2|Reported Event|Warfarin|Participants treated with warfarin
127700|NCT01662908|E1|Reported Event|Edoxaban|Participants treated with edoxaban
127701|NCT01662882|B4|Baseline|Total|Total of all reporting groups
127702|NCT01662882|B3|Baseline|MCI Subjects|"MCI (mild cognitive impairment)
florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
127703|NCT01662882|B2|Baseline|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
127704|NCT01662882|B1|Baseline|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
127705|NCT01662882|P3|Participant Flow|MCI Subjects|"MCI (mild cognitive impairment)
florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
127706|NCT01662882|P2|Participant Flow|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
127707|NCT01662882|P1|Participant Flow|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
127708|NCT01662882|O3|Outcome|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
127709|NCT01662882|O2|Outcome|MCI Subjects|"MCI (mild cognitive impairment)
florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
127710|NCT01662882|O1|Outcome|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
127711|NCT01662882|O3|Outcome|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
127712|NCT01662882|O2|Outcome|MCI Subjects|"MCI (mild cognitive impairment)
florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
127713|NCT01662882|O1|Outcome|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
127714|NCT01662882|E3|Reported Event|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
127715|NCT01662882|E2|Reported Event|MCI Subjects|"MCI (mild cognitive impairment)
florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
127716|NCT01662882|E1|Reported Event|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
127717|NCT01662856|B3|Baseline|Total|Total of all reporting groups
127718|NCT01662856|B2|Baseline|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
127719|NCT01662856|B1|Baseline|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
127720|NCT01662856|P2|Participant Flow|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
127721|NCT01662856|P1|Participant Flow|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
127722|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
127723|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
127724|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
127725|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
127726|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
127727|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
127728|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
127729|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
127730|NCT01662856|E2|Reported Event|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
127731|NCT01662856|E1|Reported Event|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
127732|NCT01662791|B3|Baseline|Total|Total of all reporting groups
127733|NCT01662791|B2|Baseline|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
127734|NCT01662791|B1|Baseline|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127735|NCT01662791|P2|Participant Flow|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day; they did not take part in the second part of the study.
127736|NCT01662791|P1|Participant Flow|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO twice a day (BID) for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127737|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
127738|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127739|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
127740|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127741|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
127742|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127743|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
127744|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127745|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
127746|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127747|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
127748|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127749|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
127750|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127751|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
127752|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127753|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
127754|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127755|NCT01662791|E2|Reported Event|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
127756|NCT01662791|E1|Reported Event|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.
Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
127757|NCT01662765|B3|Baseline|Total|Total of all reporting groups
127758|NCT01662765|B2|Baseline|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
127759|NCT01662765|B1|Baseline|Conservative|"Conservative treatment described as follow:
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.
postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry."
127760|NCT01662765|P2|Participant Flow|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
127761|NCT01662765|P1|Participant Flow|Conservative|"Conservative treatment described as follow:
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.
postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.
conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
127762|NCT01662765|O2|Outcome|Surgery|Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
128309|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
127763|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
127764|NCT01662765|O2|Outcome|Surgery|Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
127765|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
127812|NCT01662583|O1|Outcome|Educational Text Message|"Educational text message reminder
Text Message
Written reminder"
136574|NCT01627002|O6|Outcome|Part A Placebo|
127766|NCT01662765|O2|Outcome|Conservative|"Conservative treatment described as follow:
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.
postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.
conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
127767|NCT01662765|O1|Outcome|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.
Surgery: modified umbilectomy"
127768|NCT01662765|O2|Outcome|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
127769|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.
postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.
conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
127770|NCT01662765|E2|Reported Event|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
Approximation of the subcutaneous tissue with a single purse-string absorbable suture."
127771|NCT01662765|E1|Reported Event|Conservative|"Conservative treatment described as follow:
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
127772|NCT01662648|B3|Baseline|Total|Total of all reporting groups
127773|NCT01662648|B2|Baseline|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127774|NCT01662648|B1|Baseline|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127775|NCT01662648|P2|Participant Flow|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127776|NCT01662648|P1|Participant Flow|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127777|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127778|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127779|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127780|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127781|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127804|NCT01662583|B3|Baseline|Written Reminder Only|"written reminder at time of vaccination
Written reminder"
127782|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127783|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127813|NCT01662583|O3|Outcome|Written Reminder Only|"written reminder at time of vaccination
Written reminder"
127784|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127785|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127786|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127787|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127788|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127789|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127790|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127791|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127792|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127793|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127794|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127795|NCT01662648|E2|Reported Event|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
127796|NCT01662648|E1|Reported Event|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
127797|NCT01662635|B1|Baseline|Demographics and Clinical Features of Overall Population|The baseline characteristics of our population were on basis of the presence or absence of ALK gene.
127798|NCT01662635|P1|Participant Flow|Determination of ALK by FISH, IHC and RT-qPCR|"The only inclusion criterion was the availability of tissue for biomarker studies.
We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); using the commercially mouse monoclonal ALK antibody for IHC and . Variants 1, 2, 3a, 4 and 5. The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies)"
127799|NCT01662635|O3|Outcome|RT-qPCR Test|The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies) and the following Taqman assays: Hs03654556_ft (E13;A20), Hs03654557_ft (E20;A20), Hs03654558_ft (E6;A20), Hs03654560_ft (E17;A20), and Hs03654559_ft (E18;A20). Hs02758991_ft (GAPDH) assays, whose expression levels are known to be nearly stable among lung tumors
127800|NCT01662635|O2|Outcome|IHC Test|using the commercially mouse monoclonal ALK antibody (dilution 1:25, clone 5A4; Abcam, Cambridge, UK), with OptiView DAB detection Kit (Ventana, Tucson, Arizona, USA). ALK IHC was performed according to the protocols provided by the antibody.
127801|NCT01662635|O1|Outcome|FISH Test|We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); Abbott Molecular, Abbott Park, IL, USA). Slide washing, and counterstaining by DAPI were done following the manufacturer´s protocol (Abbott Molecular, Abbott Park, IL, USA).
128310|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
127807|NCT01662583|P3|Participant Flow|Written Reminder Only|"written reminder at time of vaccination
Written reminder"
127808|NCT01662583|P2|Participant Flow|Plain Text Message|"plain text message reminder
Text Message
Written reminder"
127809|NCT01662583|P1|Participant Flow|Educational Text Message|"Educational text message reminder
Text Message
Written reminder"
127810|NCT01662583|O3|Outcome|Written Reminder Only|"written reminder at time of vaccination
Written reminder"
127811|NCT01662583|O2|Outcome|Plain Text Message|"plain text message reminder
Text Message
Written reminder"
127814|NCT01662583|O2|Outcome|Plain Text Message|"plain text message reminder
Text Message
Written reminder"
127815|NCT01662583|O1|Outcome|Educational Text Message|"Educational text message reminder
Text Message
Written reminder"
127816|NCT01662583|E3|Reported Event|Written Reminder Only|"written reminder at time of vaccination
Written reminder"
127817|NCT01662583|E2|Reported Event|Plain Text Message|"plain text message reminder
Text Message
Written reminder"
127818|NCT01662583|E1|Reported Event|Educational Text Message|"Educational text message reminder
Text Message
Written reminder"
127819|NCT01662531|B3|Baseline|Total|Total of all reporting groups
127820|NCT01662531|B2|Baseline|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127821|NCT01662531|B1|Baseline|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127822|NCT01662531|P1|Participant Flow|rIX-FP|"Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) will be administered by IV infusion as routine weekly prophylaxis and episodic treatment for bleeding episodes.
rIX-FP: Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)"
127823|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127824|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127825|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127826|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127827|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127828|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127829|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127830|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127831|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127832|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127833|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127834|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127835|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
136948|NCT01624350|O1|Outcome|Permacol Collagen Paste - 3 Month Follow up|
127836|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127837|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127863|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
128532|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
127838|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127839|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127840|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127841|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127842|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127843|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127844|NCT01662531|E1|Reported Event|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
127845|NCT01662440|B5|Baseline|Total|Total of all reporting groups
127846|NCT01662440|B4|Baseline|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
127847|NCT01662440|B3|Baseline|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
127848|NCT01662440|B2|Baseline|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127849|NCT01662440|B1|Baseline|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127850|NCT01662440|P4|Participant Flow|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
127851|NCT01662440|P3|Participant Flow|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
127852|NCT01662440|P2|Participant Flow|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127853|NCT01662440|P1|Participant Flow|R/JE – Conv|Subjects received Rabies and Japanese Encephalitis (JE) vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127854|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
127855|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
127856|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127857|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127858|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
127859|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
127860|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
128149|NCT01661179|P1|Participant Flow|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
127861|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127862|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
128533|NCT01660191|E3|Reported Event|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
127864|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127865|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127866|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
127867|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127868|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127869|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
127870|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127871|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127872|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
127873|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127874|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127875|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
127876|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127877|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127878|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
127879|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127880|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127881|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
127882|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127883|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127884|NCT01662440|O2|Outcome|JE – Conv|Group Description Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127885|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127886|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
127887|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
128150|NCT01661179|O1|Outcome|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
127888|NCT01662440|O2|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
127889|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127890|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
127891|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127892|NCT01662440|O2|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
127893|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127894|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
127895|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127896|NCT01662440|E4|Reported Event|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
127897|NCT01662440|E3|Reported Event|R – Conv|Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
127898|NCT01662440|E2|Reported Event|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
127899|NCT01662440|E1|Reported Event|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
127900|NCT01662362|B1|Baseline|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.
Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
127901|NCT01662362|P1|Participant Flow|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.
Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
127902|NCT01662362|O1|Outcome|Testing Donor Specimens With ESA Chagas|Test blood donor specimens that are ABBOTT PRISM Chagas Nonreactive with ESA Chagas. These specimens will be unidentified specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.
127903|NCT01662362|O1|Outcome|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.
Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
127904|NCT01662362|E1|Reported Event|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.
Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
127905|NCT01662310|B1|Baseline|Entire Study Population|All the participants who were enrolled.
127906|NCT01662310|P5|Participant Flow|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
127907|NCT01662310|P4|Participant Flow|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
127908|NCT01662310|P3|Participant Flow|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
127909|NCT01662310|P2|Participant Flow|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
127910|NCT01662310|P1|Participant Flow|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 milligram per day (mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
127911|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
128231|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
127912|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
128235|NCT01660763|B2|Baseline|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
127913|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
127914|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
127915|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
127916|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
127917|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
127918|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
127919|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
127920|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
127921|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
127922|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
127923|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
127924|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
127925|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
127926|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
127927|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
127928|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
127929|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
127930|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
127931|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
127932|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
127933|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
127934|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
127935|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
128151|NCT01661179|E1|Reported Event|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
136949|NCT01624350|O1|Outcome|Permacol Collagen Paste|
127936|NCT01662310|E5|Reported Event|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
127937|NCT01662310|E4|Reported Event|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
127938|NCT01662310|E3|Reported Event|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
127939|NCT01662310|E2|Reported Event|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
127940|NCT01662310|E1|Reported Event|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
127941|NCT01662115|B4|Baseline|Total|Total of all reporting groups
127942|NCT01662115|B3|Baseline|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
127943|NCT01662115|B2|Baseline|Regular Chewing Gum|"100 subjects who will be part of a control group
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
127944|NCT01662115|B1|Baseline|Nicotine Gum|"100 subjects who will actually get the intervention medication
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
127945|NCT01662115|P3|Participant Flow|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
127946|NCT01662115|P2|Participant Flow|Regular Chewing Gum|"100 subjects who will be part of a control group
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
127947|NCT01662115|P1|Participant Flow|Nicotine Gum|"100 subjects who will actually get the intervention medication
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
127948|NCT01662115|O3|Outcome|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
127949|NCT01662115|O2|Outcome|Regular Chewing Gum|"100 subjects who will be part of a control group
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
127950|NCT01662115|O1|Outcome|Nicotine Gum|"100 subjects who will actually get the intervention medication
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
127951|NCT01662115|O3|Outcome|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
127952|NCT01662115|O2|Outcome|Regular Chewing Gum|"100 subjects who will be part of a control group
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
127953|NCT01662115|O1|Outcome|Nicotine Gum|"100 subjects who will actually get the intervention medication
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
127954|NCT01662115|O3|Outcome|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
127955|NCT01662115|O2|Outcome|Regular Chewing Gum|"100 subjects who will be part of a control group
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
127956|NCT01662115|O1|Outcome|Nicotine Gum|"100 subjects who will actually get the intervention medication
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
127957|NCT01662115|O3|Outcome|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
127958|NCT01662115|O2|Outcome|Regular Chewing Gum|"100 subjects who will be part of a control group
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
127959|NCT01662115|O1|Outcome|Nicotine Gum|"100 subjects who will actually get the intervention medication
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
127960|NCT01662115|E3|Reported Event|No Gum|100 subjects who will not get neither the intervention nor the placebo gum.
127961|NCT01662115|E2|Reported Event|Regular Chewing Gum|"100 subjects who will be part of a control group
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first"
127962|NCT01662115|E1|Reported Event|Nicotine Gum|"100 subjects who will actually get the intervention medication
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first"
127963|NCT01662102|B3|Baseline|Total|Total of all reporting groups
127964|NCT01662102|B2|Baseline|Rituximab|"Patients will receive 375 mg/m^2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.
Rituximab: Group B: Response maintenance with 375 mg/m^2 of rituximab every 8 weeks for 24 months (12 infusions)"
127965|NCT01662102|B1|Baseline|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.
Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
128152|NCT01661140|B1|Baseline|Initial Phase|At Week 0 participants started open-label tocilizumab and open-label MTX for 24 weeks.
127966|NCT01662102|P2|Participant Flow|Rituximab|"Patients will receive 375 mg/m^2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.
Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
128314|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
136575|NCT01627002|O5|Outcome|Part A PA401 10 mg|
127967|NCT01662102|P1|Participant Flow|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.
Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
127968|NCT01662102|O2|Outcome|Rituximab|"Patients will receive 375 mg/m2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.
Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
127969|NCT01662102|O1|Outcome|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m2); Day 7,8, or 9 rituximab (250 mg/m2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.
Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
127970|NCT01662102|E2|Reported Event|Rituximab|"Patients will receive 375 mg/m2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.
Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
127971|NCT01662102|E1|Reported Event|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m2); Day 7,8, or 9 rituximab (250 mg/m2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.
Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
127972|NCT01662063|B3|Baseline|Total|Total of all reporting groups
127973|NCT01662063|B2|Baseline|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127974|NCT01662063|B1|Baseline|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
127975|NCT01662063|P3|Participant Flow|Not Treated|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) were enrolled in this LTE study for an additional 96 weeks. Participants who met Screening criteria but did not receive treatment were excluded from analysis and reported in a separate arm.
127976|NCT01662063|P2|Participant Flow|SC TCZ Every Week (QW)|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127977|NCT01662063|P1|Participant Flow|Subcutaneous (SC) Tocilizumab (TCZ) Every 2 Weeks (Q2W)|Participants with moderate to severe rheumatoid arthritis (RA) who completed treatment with SC or intravenous (IV) TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this long-term extension (LTE) study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 milligrams (mg) Q2W.
127978|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127979|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
127980|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127981|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128221|NCT01660802|B1|Baseline|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
128222|NCT01660802|P2|Participant Flow|Sham|Sham administered in the study eye on Day 1.
128038|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
127982|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127983|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
127984|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127985|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
127986|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127987|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
127988|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127989|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
127990|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127991|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
127992|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127993|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
127994|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127995|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
127996|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127997|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
127998|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
127999|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128000|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
128001|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
128002|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
128003|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
128004|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128005|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128006|NCT01662063|O1|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128007|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128008|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128009|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128010|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128011|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128012|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128013|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128014|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128015|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128016|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128017|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128018|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128223|NCT01660802|P1|Participant Flow|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
136950|NCT01624350|E1|Reported Event|Permacol Collagen Paste|
128019|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128020|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128021|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128022|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128023|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128024|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128025|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128026|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128027|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128028|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128029|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128030|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128031|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128032|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128033|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128034|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128035|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128036|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128037|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128039|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128040|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128041|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128042|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128043|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128044|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128045|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128046|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128047|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128048|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128049|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128050|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128051|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128052|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128053|NCT01662063|E2|Reported Event|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
128054|NCT01662063|E1|Reported Event|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
128055|NCT01662024|B1|Baseline|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures"
128126|NCT01661270|P2|Participant Flow|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128224|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
128233|NCT01660802|E1|Reported Event|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
128234|NCT01660763|B3|Baseline|Total|Total of all reporting groups
128315|NCT01660321|E1|Reported Event|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
128056|NCT01662024|P1|Participant Flow|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period."
128057|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
128058|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
128059|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
128060|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures"
128061|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
128062|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. D"
128063|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period."
128064|NCT01662024|E1|Reported Event|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
128065|NCT01661972|B3|Baseline|Total|Total of all reporting groups
128066|NCT01661972|B2|Baseline|Phase 2|Capecitabine at the recommended dose based on Phase 1 (850mg/m2) given on days 1-14. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
128067|NCT01661972|B1|Baseline|Phase 1|Capecitabine is given days 1-14 of a 21 day cycle. Cohort 1 will receive 850mg/m2 Capecitabine and Cohort 2 will receive 1000mg/m2. Aflibercept 6 mg/kg is given intravenously every 3 weeks.
128068|NCT01661972|P2|Participant Flow|Phase 2|Capecitabine at the recommended dose based on Phase 1 (850mg/m2) given on days 1-14. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
128069|NCT01661972|P1|Participant Flow|Phase 1|Capecitabine is given days 1-14 of a 21 day cycle. Cohort 1 will receive 850mg/m2 Capecitabine and Cohort 2 will receive 1000mg/m2. Aflibercept 6 mg/kg is given intravenously every 3 weeks.
128070|NCT01661972|O1|Outcome|Phase 2|Capecitabine at the recommended dose based on Phase 1, given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
128071|NCT01661972|O1|Outcome|Phase 2|Capecitabine at the recommended dose based on Phase 1, given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
128072|NCT01661972|O1|Outcome|Phase 2|Capecitabine at the recommended dose based on Phase 1, given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
128073|NCT01661972|O2|Outcome|Phase 1 Cohort 2|Capecitabine 1000 mg/m2 given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
128074|NCT01661972|O1|Outcome|Phase 1 Cohort 1|Capecitabine 850mg/m2 given days 1-14 and off days 15-21. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
128075|NCT01661972|O1|Outcome|Phase 1|Aflibercept 6 mg/kg given intravenously every 3 weeks. Capecitabine was given at 850mg/m2 for the first cohort and at 1000mg/m2 for the second cohort.
128076|NCT01661972|E2|Reported Event|Phase 2|Capecitabine at the recommended dose based on Phase 1 (850mg/m2) given on days 1-14. Aflibercept 6 mg/kg given intravenously every 3 weeks. Both agents are administered on a 21-day cycle.
128077|NCT01661972|E1|Reported Event|Phase 1|Capecitabine is given days 1-14 of a 21 day cycle. Cohort 1 will receive 850mg/m2 Capecitabine and Cohort 2 will receive 1000mg/m2. Aflibercept 6 mg/kg is given intravenously every 3 weeks.
128078|NCT01661933|B1|Baseline|Gluten Micro-challenge|Single arm, vertical. All twelve healthy adults enrolled subjects were successfully inoculated with hookworm and there was no serious adverse response. Individual hemoglobin levels were all normal and the group mean had significantly increased unexpectedly at completion of the study. Histology was not graded until after low-dose challenge but retrospectively confirmed enrollment Marsh scores of M0-8, M1-1, M2-2 and M3a-1. All participants were complying with a gluten-free diet, were symptomatically well and had a normal anti-tTG.
128225|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
128079|NCT01661933|P1|Participant Flow|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
128080|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
128081|NCT01661933|O1|Outcome|Necator Americanus, Pre-gluten Challenge|Single arm, vertical. Ten of 12 participants enrolled based on symptomatic tolerance of gluten and satisfactory histology during and after micro-challenge. 2 were withdrawn pre-GC-1g, one who was symptomatically intolerant of gluten and one who had M3a after micro-challenge. Pre-GC1g scores.
128082|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
128083|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, assessments including histology were performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
128084|NCT01661933|E1|Reported Event|Gluten Micro-challenge|Single arm, longitudinal study of responses to escalating gluten doses in people with celiac disease after infection with Necator americanus, a human hookworm.
128085|NCT01661881|B1|Baseline|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;
1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity."
128086|NCT01661881|P1|Participant Flow|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;
1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity."
128087|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;
1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
128088|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;
1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
128127|NCT01661270|P1|Participant Flow|Placebo|Placebo for aflibercept intravenous (IV) infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128226|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
128227|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
128089|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;
1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
128090|NCT01661881|E1|Reported Event|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;
1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity.
Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
128091|NCT01661790|B3|Baseline|Total|Total of all reporting groups
128092|NCT01661790|B2|Baseline|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks
Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
128093|NCT01661790|B1|Baseline|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week
Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
128094|NCT01661790|P2|Participant Flow|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks
Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
128095|NCT01661790|P1|Participant Flow|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week
Cisplatin: Cisplatin 30mg,intrapleural administration,each 2 week"
128096|NCT01661790|O2|Outcome|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks
Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
128097|NCT01661790|O1|Outcome|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week
Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
128098|NCT01661790|E2|Reported Event|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks
Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
128099|NCT01661790|E1|Reported Event|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week
Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
128100|NCT01661621|B3|Baseline|Total|Total of all reporting groups
128101|NCT01661621|B2|Baseline|Group 2|"α-blockers (Doxazosin 4 mg QD)
Doxazosin 4 mg QD: Group 2"
128102|NCT01661621|B1|Baseline|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)
Detrusitol 4 mg QD: Group 1"
128103|NCT01661621|P2|Participant Flow|Group 2|"α-blockers (Doxazosin 4 mg QD)
Doxazosin 4 mg QD: Group 2"
128104|NCT01661621|P1|Participant Flow|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)
Detrusitol 4 mg QD: Group 1"
128105|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)
Doxazosin 4 mg QD: Group 2"
128106|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)
Detrusitol 4 mg QD: Group 1"
128107|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)
Doxazosin 4 mg QD: Group 2"
128108|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)
Detrusitol 4 mg QD: Group 1"
128109|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)
Doxazosin 4 mg QD: Group 2"
128110|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)
Detrusitol 4 mg QD: Group 1"
128111|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)
Doxazosin 4 mg QD: Group 2"
128112|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)
Detrusitol 4 mg QD: Group 1"
128113|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)
Doxazosin 4 mg QD: Group 2"
128114|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)
Detrusitol 4 mg QD: Group 1"
128115|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)
Doxazosin 4 mg QD: Group 2"
128116|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)
Detrusitol 4 mg QD: Group 1"
128117|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)
Doxazosin 4 mg QD: Group 2"
128118|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)
Detrusitol 4 mg QD: Group 1"
128119|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)
Doxazosin 4 mg QD: Group 2"
128120|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)
Detrusitol 4 mg QD: Group 1"
128121|NCT01661621|E2|Reported Event|Group 2|"α-blockers (Doxazosin 4 mg QD)
Doxazosin 4 mg QD: Group 2"
128122|NCT01661621|E1|Reported Event|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)
Detrusitol 4 mg QD: Group 1"
128123|NCT01661270|B3|Baseline|Total|Total of all reporting groups
128124|NCT01661270|B2|Baseline|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128125|NCT01661270|B1|Baseline|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128148|NCT01661179|B1|Baseline|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
128128|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128129|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128130|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128131|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128132|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128133|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128134|NCT01661270|E3|Reported Event|Mixed Administration (Placebo and Aflibercept)|Participants who were originally randomized to receive either Placebo or Aflibercept, actually received both the treatment (Placebo and Aflibercept).
128135|NCT01661270|E2|Reported Event|Aflibercept Only|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128136|NCT01661270|E1|Reported Event|Placebo Only|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
128137|NCT01661205|B1|Baseline|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
128138|NCT01661205|P1|Participant Flow|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
128139|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
128140|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
128141|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
128142|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
128143|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
128144|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
128145|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
128146|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
128147|NCT01661205|E1|Reported Event|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
128153|NCT01661140|P3|Participant Flow|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128154|NCT01661140|P2|Participant Flow|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128155|NCT01661140|P1|Participant Flow|Initial Phase|At Week 0 participants started open-label tocilizumab and open-label methotrexate (MTX) for 24 weeks, which was the initial phase of the study.
128156|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128157|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128158|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128159|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128160|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128161|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128162|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128163|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128164|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128165|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128228|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
128229|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
128230|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
136951|NCT01624259|B3|Baseline|Total|Total of all reporting groups
128166|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128167|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128168|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128169|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128170|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128171|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128172|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128173|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128174|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128175|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128176|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128177|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128178|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
139748|NCT01609257|B3|Baseline|Total|Total of all reporting groups
128179|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128180|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128181|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128182|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128183|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128184|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy..
128185|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128186|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128187|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128188|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128189|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128190|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
128191|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
141986|NCT01600677|B3|Baseline|Total|Total of all reporting groups
128192|NCT01661140|E3|Reported Event|Methotrexate (MTX) Maintenance Group|"After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
Adverse events in this reporting group are those occurring in the double-blind phase only."
128193|NCT01661140|E2|Reported Event|Methotrexate (MTX) Tapering Group|"After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
Adverse events in this reporting group are those occurring in the double-blind phase only."
128194|NCT01661140|E1|Reported Event|Initial Phase|"At Week 0 participants will start open-label tocilizumab and open-label MTX for 24 weeks, which is the initial phase of the study.
Adverse events in this reporting group are those occurring in the open-label phase only."
128195|NCT01661114|B1|Baseline|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
128196|NCT01661114|P1|Participant Flow|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
128197|NCT01661114|O1|Outcome|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
128198|NCT01661114|O1|Outcome|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
128199|NCT01661114|E1|Reported Event|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
128200|NCT01661062|B1|Baseline|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
128201|NCT01661062|P1|Participant Flow|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
128202|NCT01661062|O1|Outcome|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
128203|NCT01661062|O1|Outcome|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
128204|NCT01661062|E1|Reported Event|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
128205|NCT01660906|B1|Baseline|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
128206|NCT01660906|P1|Participant Flow|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
128207|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
128208|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
128209|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
128210|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
128211|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
128212|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
128213|NCT01660906|E1|Reported Event|Dasatinib|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
128214|NCT01660815|B1|Baseline|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.
florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
128215|NCT01660815|P1|Participant Flow|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.
florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
128216|NCT01660815|O2|Outcome|70-kg Model|Radiation dose estimate using a 70-kg model.
128217|NCT01660815|O1|Outcome|50-kg Model|Radiation dose estimate using a 50-kg model.
128218|NCT01660815|E1|Reported Event|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.
florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
128219|NCT01660802|B3|Baseline|Total|Total of all reporting groups
128220|NCT01660802|B2|Baseline|Sham|Sham administered in the study eye on Day 1.
128232|NCT01660802|E2|Reported Event|Sham|Sham administered in the study eye on Day 1.
128236|NCT01660763|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
128237|NCT01660763|P2|Participant Flow|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
128238|NCT01660763|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
128239|NCT01660763|O2|Outcome|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
128240|NCT01660763|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
128241|NCT01660763|E2|Reported Event|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
128242|NCT01660763|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
128243|NCT01660737|B1|Baseline|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128244|NCT01660737|P1|Participant Flow|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128245|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128246|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128247|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128248|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128249|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128250|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128251|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128252|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128253|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128254|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128255|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128256|NCT01660737|O1|Outcome|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128257|NCT01660737|E1|Reported Event|PASCALLERG® Tablets in Patients With Hay Fever|Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
128258|NCT01660698|B3|Baseline|Total|Total of all reporting groups
128259|NCT01660698|B2|Baseline|Probiotic|"probiotic blended in maltodextrin
Probiotic : probiotic blended in maltodextrin powder"
128260|NCT01660698|B1|Baseline|Placebo|"maltodextrin powder
Maltodextrin : maltodextrin powder"
128261|NCT01660698|P2|Participant Flow|Probiotic|"probiotic blended in maltodextrin
Probiotic : probiotic blended in maltodextrin powder"
128262|NCT01660698|P1|Participant Flow|Placebo|"maltodextrin powder
Maltodextrin : maltodextrin powder"
128263|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin
Probiotic : probiotic blended in maltodextrin powder"
128264|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder
Maltodextrin : maltodextrin powder"
128265|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin
Probiotic : probiotic blended in maltodextrin powder"
128266|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder
Maltodextrin : maltodextrin powder"
128267|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin
Probiotic : probiotic blended in maltodextrin powder"
128268|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder
Maltodextrin : maltodextrin powder"
128269|NCT01660698|E2|Reported Event|Probiotic|"probiotic blended in maltodextrin
Probiotic : probiotic blended in maltodextrin powder"
128270|NCT01660698|E1|Reported Event|Placebo|"maltodextrin powder
Maltodextrin : maltodextrin powder"
128271|NCT01660672|B1|Baseline|LEVETIRACETAM|"Open label, dose escalation to optimal dose.
LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
142220|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
128272|NCT01660672|P1|Participant Flow|LEVETIRACETAM|"Open label, dose escalation to optimal dose.
LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
128316|NCT01660230|B13|Baseline|Total|Total of all reporting groups
128273|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.
LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
128274|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.
LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
128275|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.
LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
128276|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.
LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
128277|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.
LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
128278|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.
LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
128279|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.
LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
128280|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.
LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
128281|NCT01660672|E1|Reported Event|LEVETIRACETAM|"Open label, dose escalation to optimal dose.
LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. This dose was effective in 7/7 children."
128282|NCT01659736|B3|Baseline|Total|Total of all reporting groups
128283|NCT01659736|B2|Baseline|TMS-Sham|"This is a sham TMS condition
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128284|NCT01659736|B1|Baseline|TMS Therapy|"TMS treatment
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128285|NCT01659736|P2|Participant Flow|TMS-Sham|"This is a sham TMS condition
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128286|NCT01659736|P1|Participant Flow|TMS-Treatment|"TMS treatment
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128287|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128288|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128289|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128290|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128291|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128292|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128293|NCT01659736|O2|Outcome|TMS- Sham|"This is a sham TMS condition
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128294|NCT01659736|O1|Outcome|TMS- Treatment|"TMS treatment
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128295|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128296|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128297|NCT01659736|E2|Reported Event|TMS-Sham|"This is a sham TMS condition
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128298|NCT01659736|E1|Reported Event|TMS-Treatment|"TMS treatment
TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
128299|NCT01660334|B1|Baseline|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
128300|NCT01660334|P1|Participant Flow|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
128301|NCT01660334|O1|Outcome|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
128302|NCT01660334|O1|Outcome|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
128303|NCT01660334|E1|Reported Event|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
128311|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
128312|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
128313|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
128317|NCT01660230|B12|Baseline|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128318|NCT01660230|B11|Baseline|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128319|NCT01660230|B10|Baseline|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128320|NCT01660230|B9|Baseline|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128321|NCT01660230|B8|Baseline|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128322|NCT01660230|B7|Baseline|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128323|NCT01660230|B6|Baseline|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128324|NCT01660230|B5|Baseline|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128325|NCT01660230|B4|Baseline|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128326|NCT01660230|B3|Baseline|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128327|NCT01660230|B2|Baseline|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128328|NCT01660230|B1|Baseline|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128329|NCT01660230|P12|Participant Flow|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128330|NCT01660230|P11|Participant Flow|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128331|NCT01660230|P10|Participant Flow|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128332|NCT01660230|P9|Participant Flow|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128333|NCT01660230|P8|Participant Flow|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128334|NCT01660230|P7|Participant Flow|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128335|NCT01660230|P6|Participant Flow|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128336|NCT01660230|P5|Participant Flow|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128337|NCT01660230|P4|Participant Flow|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128338|NCT01660230|P3|Participant Flow|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128339|NCT01660230|P2|Participant Flow|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128340|NCT01660230|P1|Participant Flow|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128341|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes
0.9% NaCl in water"
128510|NCT01660191|B2|Baseline|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
128342|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128343|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128344|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128345|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128346|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes
0.9% NaCl in water"
128347|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128348|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128349|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128350|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128351|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes
0.9% NaCl in water"
128352|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128353|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128354|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128355|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128356|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes
0.9% NaCl in water"
128357|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128358|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128359|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128360|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128361|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes
0.9% NaCl in water"
128362|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128363|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128364|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128365|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128366|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes
0.9% NaCl in water"
128367|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128368|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128511|NCT01660191|B1|Baseline|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
128369|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128370|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128371|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128372|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128373|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128374|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128375|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128376|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128377|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128378|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128379|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128380|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128381|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128382|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128383|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128384|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128385|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128386|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128387|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128388|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128389|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128390|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128391|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128392|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128393|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128394|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128395|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128396|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128515|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
128397|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128398|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128399|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128400|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128401|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128402|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128403|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128404|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128405|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128406|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128407|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128408|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128409|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128410|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128411|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128412|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128413|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128414|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128415|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128416|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128417|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128418|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128419|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128420|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128421|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128422|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128423|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128424|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128512|NCT01660191|P3|Participant Flow|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
142228|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
128425|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128426|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128427|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128428|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128429|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128430|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128431|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128432|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128433|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128434|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128435|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128436|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128437|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128438|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128439|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128440|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128441|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128442|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128443|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128444|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128445|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128446|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128447|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128448|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128449|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128450|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128451|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128452|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128513|NCT01660191|P2|Participant Flow|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
142648|NCT01598064|E1|Reported Event|GK#10|GK#10 1 pk tid for 8 weeks
128453|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128518|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
128519|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
128454|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128455|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128456|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128457|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128458|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128459|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128460|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128461|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128462|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128463|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128464|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128465|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128466|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128467|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128468|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128469|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128470|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128471|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128472|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128473|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128474|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128475|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128476|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128477|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128478|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128479|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128480|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128514|NCT01660191|P1|Participant Flow|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
142649|NCT01597908|B3|Baseline|Total|Total of all reporting groups
128481|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128482|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128483|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes
0.9% NaCl in water"
128484|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128485|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128486|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128487|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128488|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128489|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128490|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128491|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128492|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128493|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128494|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128495|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128496|NCT01660230|E12|Reported Event|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)
0.9% NaCl in water"
128497|NCT01660230|E11|Reported Event|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128498|NCT01660230|E10|Reported Event|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128499|NCT01660230|E9|Reported Event|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128500|NCT01660230|E8|Reported Event|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses
3K3A-APC, diluted in 0.9% sodium chloride in water"
128501|NCT01660230|E7|Reported Event|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128502|NCT01660230|E6|Reported Event|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128503|NCT01660230|E5|Reported Event|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128504|NCT01660230|E4|Reported Event|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128505|NCT01660230|E3|Reported Event|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128506|NCT01660230|E2|Reported Event|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128507|NCT01660230|E1|Reported Event|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes
3K3A-APC, diluted in 0.9% sodium chloride in water"
128508|NCT01660191|B4|Baseline|Total|Total of all reporting groups
128509|NCT01660191|B3|Baseline|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
128516|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
128517|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
128534|NCT01660191|E2|Reported Event|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
128535|NCT01660191|E1|Reported Event|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
128536|NCT01660022|B7|Baseline|Total|Total of all reporting groups
128537|NCT01660022|B6|Baseline|Placebo|Cohorts 1, 2, 3, 4 and 5
128538|NCT01660022|B5|Baseline|Cohort 5|Sequence 1: OZ439 800mg Sequence 2: OZ439 800 mg / PQP 1440 mg
128539|NCT01660022|B4|Baseline|Cohort 4|Sequence 1: OZ439 300mg Sequence 2: OZ439 300 mg / PQP 1440 mg
128540|NCT01660022|B3|Baseline|Cohort 3|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 1440 mg
128541|NCT01660022|B2|Baseline|Cohort 2|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 480 mg
128542|NCT01660022|B1|Baseline|Cohort 1|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 160 mg
128543|NCT01660022|P6|Participant Flow|Placebo|Cohorts 1, 2, 3, 4 and 5
128544|NCT01660022|P5|Participant Flow|Cohort 5|Sequence 1: OZ439 800mg Sequence 2: OZ439 800mg+PQP 1440mg
128545|NCT01660022|P4|Participant Flow|Cohort 4|Sequence 1: OZ439 300mg Sequence 2: OZ439 300mg+PQP 1440mg
128546|NCT01660022|P3|Participant Flow|Cohort 3|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg+PQP 1440mg
128547|NCT01660022|P2|Participant Flow|Cohort 2|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg+PQP 480mg
128548|NCT01660022|P1|Participant Flow|Cohort 1|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg / PQP 160mg
128549|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
128550|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
128551|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
128552|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
128553|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
128554|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
128555|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
128556|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
128557|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
128558|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
128559|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
128560|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
128561|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
128562|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
128563|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
128564|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
128565|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
128566|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
128567|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
128568|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
128569|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
128570|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
128571|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
128572|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
128573|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
128574|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
128575|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
128576|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
128577|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
128578|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
142860|NCT01597050|B2|Baseline|Placebo|"Placebo, bid
Placebo: Placebo, bid"
128579|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
128580|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
128581|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
128582|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
128583|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
128584|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
128585|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
128586|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
128587|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
128588|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
128589|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
128590|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
128591|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
128592|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
128593|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
128594|NCT01660022|E9|Reported Event|Placebo|Cohorts 1, 2, 3, 4 and 5
128595|NCT01660022|E8|Reported Event|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
129174|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
128596|NCT01660022|E7|Reported Event|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
128597|NCT01660022|E6|Reported Event|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
128598|NCT01660022|E5|Reported Event|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
128599|NCT01660022|E4|Reported Event|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
128600|NCT01660022|E3|Reported Event|OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
128601|NCT01660022|E2|Reported Event|OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
128602|NCT01660022|E1|Reported Event|OZ439 100mg|Cohorts 1, 2 and 3 OZ439 100mg
128603|NCT01659996|B4|Baseline|Total|Total of all reporting groups
128604|NCT01659996|B3|Baseline|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
128605|NCT01659996|B2|Baseline|Menactra + Pentacel Vaccine Group|Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months
128606|NCT01659996|B1|Baseline|Menactra Vaccine Group|Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
128607|NCT01659996|P3|Participant Flow|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
128608|NCT01659996|P2|Participant Flow|Menactra + Pentacel Vaccine Group|All participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
128609|NCT01659996|P1|Participant Flow|Menactra Vaccine Group|All participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
128610|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
128611|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
128612|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
128613|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
128614|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
128615|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
128616|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
128617|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
128618|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
128619|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
128620|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
128621|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
128622|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
128623|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
128624|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
128625|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
128626|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
128627|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
128628|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
128629|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
128630|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
128631|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
128632|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
128633|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
128634|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
128635|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
128636|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
128637|NCT01659996|E3|Reported Event|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
129175|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
128638|NCT01659996|E2|Reported Event|Menactra + Pentacel Vaccine Group|Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months
128639|NCT01659996|E1|Reported Event|Menactra Vaccine Group|Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
128640|NCT01659853|B1|Baseline|Overall Study|"Participants were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
128641|NCT01659853|P2|Participant Flow|Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle|"Subjects were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
128642|NCT01659853|P1|Participant Flow|CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15%|"Subjects were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
128643|NCT01659853|O2|Outcome|Azelaic Acid 15%|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.
A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
128644|NCT01659853|O1|Outcome|CD07805/47 Gel 0.5 and Vehicle|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.
A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
128645|NCT01659853|O2|Outcome|Azelaic Acid Gel 15%|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.
A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
128646|NCT01659853|O1|Outcome|CD07805/47 Gel 0.5% and Vehicle|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.
A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
128647|NCT01659853|E2|Reported Event|Azelaic Acid 15%|"Participants were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
128648|NCT01659853|E1|Reported Event|CD07805/47 Gel 0.5 and Vehicle|"Participants were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
128705|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
143114|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
128649|NCT01659554|B1|Baseline|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle
Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
128650|NCT01659554|P1|Participant Flow|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle
Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
128651|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle
Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
128674|NCT01659268|E1|Reported Event|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.
The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
128652|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle
Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
128653|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle
Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
128654|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle
Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
128655|NCT01659554|E1|Reported Event|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle
Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
128656|NCT01659320|B1|Baseline|Minocycline|"Open label treatment using minocycline.
Minocycline: Minocycline 100 mg twice daily for 8 weeks"
128657|NCT01659320|P1|Participant Flow|Minocycline|"Open label treatment using minocycline.
Minocycline: Minocycline 100 mg twice daily for 8 weeks"
128658|NCT01659320|O1|Outcome|Minocycline|"Open label treatment using minocycline.
Minocycline: Minocycline 100 mg twice daily for 8 weeks"
128659|NCT01659320|E1|Reported Event|Minocycline|"Open label treatment using minocycline.
Minocycline: Minocycline 100 mg twice daily for 8 weeks"
128660|NCT01659268|B3|Baseline|Total|Total of all reporting groups
128661|NCT01659268|B2|Baseline|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.
Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
128662|NCT01659268|B1|Baseline|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.
The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
128663|NCT01659268|P2|Participant Flow|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.
Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
128664|NCT01659268|P1|Participant Flow|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.
The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
128665|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.
Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
128666|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.
The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
128667|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.
Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
128668|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.
The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
128669|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.
Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
128670|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.
The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
128671|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.
Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
128672|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.
The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
128673|NCT01659268|E2|Reported Event|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.
Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
128675|NCT01659125|B1|Baseline|OCFighter Participants|"OCFighter
OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
128676|NCT01659125|P1|Participant Flow|OCFighter Participants|"OCFighter
OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
128677|NCT01659125|O1|Outcome|OCFighter Participants|Participants who initiated treatment
128678|NCT01659125|O1|Outcome|OCFighter Participants|Participants who initiated treatment
128679|NCT01659125|E1|Reported Event|OCFighter Participants|"OCFighter
OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
128680|NCT01659021|B3|Baseline|Total|Total of all reporting groups
128681|NCT01659021|B2|Baseline|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128682|NCT01659021|B1|Baseline|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128683|NCT01659021|P2|Participant Flow|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128684|NCT01659021|P1|Participant Flow|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128685|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128686|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128687|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation
Participants in this group had 17p deletion and/or TP53 mutation."
144462|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
128688|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation
Participants in this group had 17p deletion and/or TP53 mutation."
128689|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128690|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128854|NCT01658072|B1|Baseline|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
128691|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128692|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128693|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128694|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128695|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128696|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128697|NCT01659021|E2|Reported Event|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128698|NCT01659021|E1|Reported Event|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
128699|NCT01658943|B3|Baseline|Total|Total of all reporting groups
128700|NCT01658943|B2|Baseline|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128701|NCT01658943|B1|Baseline|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128702|NCT01658943|P2|Participant Flow|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128703|NCT01658943|P1|Participant Flow|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128704|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128706|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128707|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128708|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128709|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128710|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128711|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
136576|NCT01627002|O4|Outcome|Part A PA401 3.0 mg|
128712|NCT01658943|E2|Reported Event|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128713|NCT01658943|E1|Reported Event|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
128714|NCT01658904|B4|Baseline|Total|Total of all reporting groups
128715|NCT01658904|B3|Baseline|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128716|NCT01658904|B2|Baseline|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128717|NCT01658904|B1|Baseline|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128718|NCT01658904|P3|Participant Flow|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128719|NCT01658904|P2|Participant Flow|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128720|NCT01658904|P1|Participant Flow|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128721|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128759|NCT01658735|P1|Participant Flow|H-Wave Device|"H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
129152|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
128722|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128723|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128763|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
128724|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
Carfilzomib
Melphalan
Filgrastim"
128725|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
Carfilzomib
Melphalan
Filgrastim"
128726|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.
Carfilzomib
Melphalan
Filgrastim"
128727|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128728|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128729|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128730|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128731|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128758|NCT01658735|P2|Participant Flow|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
128732|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128733|NCT01658904|E3|Reported Event|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128734|NCT01658904|E2|Reported Event|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128735|NCT01658904|E1|Reported Event|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
128736|NCT01658839|B1|Baseline|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
128737|NCT01658839|P1|Participant Flow|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
128738|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
128739|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
128740|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
128741|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
128742|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
128743|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
128744|NCT01658839|E1|Reported Event|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
128745|NCT01658813|B1|Baseline|Number of Participants|5-Fluorouracil and Interferon-alfa-2b
128746|NCT01658813|P1|Participant Flow|5-FU and Interferon-alfa-2b|All patients received 5-Fluorouracil and Interferon-alfa-2b
128747|NCT01658813|O1|Outcome|Median Survival|The median survival of patients treated on study was determined.
128748|NCT01658813|O1|Outcome|Median Duration of Response|The median duration of response was determined.
128749|NCT01658813|O1|Outcome|Response Rate|percentage of patients responding
128750|NCT01658813|O1|Outcome|Number of Responders|the number of patients responding
128751|NCT01658813|O1|Outcome|Progression Free Survival|5-Fluorouracil and Interferon-alfa-2b
128752|NCT01658813|E1|Reported Event|Number of Participants|5-Fluorouracil and Interferon-alfa-2b
128753|NCT01658735|B4|Baseline|Total|Total of all reporting groups
128754|NCT01658735|B3|Baseline|Sham Electrotherapy|"Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
128755|NCT01658735|B2|Baseline|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
128756|NCT01658735|B1|Baseline|H-Wave Device|"H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
128757|NCT01658735|P3|Participant Flow|Sham Electrotherapy|"Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
128838|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
129153|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
128760|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
128761|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
128762|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
128855|NCT01658072|P2|Participant Flow|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
128764|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
128765|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
128766|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
128767|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
128768|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
128769|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
128770|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
128771|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
128772|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
128773|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
128774|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
128775|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
128776|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
128777|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
128778|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
128839|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
128840|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
144840|NCT01588561|O2|Outcome|Placebo|Saline infusion
128779|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
128780|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
128781|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
128806|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128782|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
128783|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
128784|NCT01658735|E3|Reported Event|Sham Electrotherapy|"Sham Device plus Usual Care.
Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
128785|NCT01658735|E2|Reported Event|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care
Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
128786|NCT01658735|E1|Reported Event|H-Wave Device|"H-Wave Device with Usual Care
H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
128787|NCT01658657|B3|Baseline|Total|Total of all reporting groups
128788|NCT01658657|B2|Baseline|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.
Amlodipine
metoprolol
lisinopril/hydrochlorothiazide"
128789|NCT01658657|B1|Baseline|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
Hydrochlorothiazide
Lisinopril
Amlodipine
metoprolol"
128790|NCT01658657|P2|Participant Flow|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.
Amlodipine
metoprolol
lisinopril/hydrochlorothiazide"
128791|NCT01658657|P1|Participant Flow|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
Hydrochlorothiazide
Lisinopril
Amlodipine
metoprolol"
128792|NCT01658657|O2|Outcome|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.
Amlodipine
metoprolol
lisinopril/hydrochlorothiazide"
128793|NCT01658657|O1|Outcome|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
Hydrochlorothiazide
Lisinopril
Amlodipine
metoprolol"
128794|NCT01658657|E2|Reported Event|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.
Amlodipine
metoprolol
lisinopril/hydrochlorothiazide"
128795|NCT01658657|E1|Reported Event|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
Hydrochlorothiazide
Lisinopril
Amlodipine
metoprolol"
128796|NCT01658579|B5|Baseline|Total|Total of all reporting groups
128797|NCT01658579|B4|Baseline|Lantus Evening Then Morning|Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B.
128798|NCT01658579|B3|Baseline|Lantus Morning Then Evening|Lantus SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B.
128799|NCT01658579|B2|Baseline|HOE901-U300 Evening Then Morning|HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B.
128800|NCT01658579|B1|Baseline|HOE901-U300 Morning Then Evening|HOE901-U300 SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B.
128801|NCT01658579|P4|Participant Flow|Lantus Evening Then Morning|Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
128802|NCT01658579|P3|Participant Flow|Lantus Morning Then Evening|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
128841|NCT01658514|E3|Reported Event|Met XR|One dose of 1000 mg Metformin Extended-Release
128842|NCT01658514|E2|Reported Event|Met DR|One dose of 1000 mg Metformin Delayed-Release
128803|NCT01658579|P2|Participant Flow|HOE901-U300 Evening Then Morning|HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
128804|NCT01658579|P1|Participant Flow|HOE901-U300 Morning Then Evening|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L) (80–130 milligram per deciliter [mg/dL]).
128805|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
129165|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
128807|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128808|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128809|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128810|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128811|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128812|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128813|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128814|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128815|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128816|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128817|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128818|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128819|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128820|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128821|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128822|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128823|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128824|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128825|NCT01658579|E2|Reported Event|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128826|NCT01658579|E1|Reported Event|HOE901-U300 Combined|HOE901­U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
128827|NCT01658514|B5|Baseline|Total|Total of all reporting groups
128828|NCT01658514|B4|Baseline|Severe RI|Severe Renal Impairment = eGFR ≥15 to <30 mL/min/1.73 m²
128829|NCT01658514|B3|Baseline|Moderate RI|Moderate Renal Impairment = eGFR ≥30 to <60 mL/min/1.73 m²
128830|NCT01658514|B2|Baseline|Mild RI|Mild Renal Impairment = eGFR ≥60 to <90 mL/min/1.73 m²
128831|NCT01658514|B1|Baseline|Normal|Normal Renal Function = eGFR ≥90 mL/min/1.73 m²
128832|NCT01658514|P3|Participant Flow|Sequence BCA|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo
each treatment was separated by a wash out period of 2 to 10 days"
128833|NCT01658514|P2|Participant Flow|Sequence CAB|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo
each treatment was separated by a wash out period of 2 to 10 days"
128834|NCT01658514|P1|Participant Flow|Sequence ABC|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo
each treatment was separated by a wash out period of 2 to 10 days"
128835|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
128836|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
128837|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
128844|NCT01658436|B1|Baseline|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
128845|NCT01658436|P2|Participant Flow|BEZ235 400 mg Bid|Oral BEZ235 400 mg bid was investigated in stage 1 of study
128846|NCT01658436|P1|Participant Flow|BEZ235 300 mg|Oral BEZ235 300 mg bid was investigated in stage 1 of study
128847|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
128848|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
128849|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
128850|NCT01658436|E2|Reported Event|BEZ235 400 mg Bid|BEZ235 400 mg bid
128851|NCT01658436|E1|Reported Event|BEZ235 300 mg Bid|BEZ235 300 mg bid
128852|NCT01658072|B3|Baseline|Total|Total of all reporting groups
128853|NCT01658072|B2|Baseline|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
128856|NCT01658072|P1|Participant Flow|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
128857|NCT01658072|O2|Outcome|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
128858|NCT01658072|O1|Outcome|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
128859|NCT01658072|E2|Reported Event|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
128860|NCT01658072|E1|Reported Event|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
128861|NCT01658020|B3|Baseline|Total|Total of all reporting groups
128862|NCT01658020|B2|Baseline|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
128863|NCT01658020|B1|Baseline|DW224|Zabofloxacin 367mg tablet P.O. once daily for 3 days and then placebo P.O. once daily for 2 days
128864|NCT01658020|P2|Participant Flow|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7days
128865|NCT01658020|P1|Participant Flow|DW224|Zabofloxacin 400mg tablet P.O. once daily for 5days and Placebo P.O. once daily
128866|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
128867|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
128868|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
128869|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
128870|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
128871|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
128872|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
128873|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
128874|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily 7 days
128875|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
128876|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
128877|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
128878|NCT01658020|E2|Reported Event|Avelox|"Moxifloxacin Tablet 400mg given by oral administration
Zabofloxacin Tablet 400mg: multiple-dose"
128879|NCT01658020|E1|Reported Event|DW224|"Zabofloxacin Tablet 400mg given by oral administration
Moxifloxacin Tablet 400mg: multiple-dose"
128880|NCT01657903|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline parameters.
128881|NCT01657903|P1|Participant Flow|Overall|This was a 4-way crossover study. Participants brushed with 1.5 g of low relative dentine abrasivity (RDA) gel to foam toothpaste (Toothpaste 1) containing 1450 parts per million (ppm) of fluoride (F) as sodium fluoride (NaF) and 5% weight by weight (w/w) potassium nitrate (KNO3); 1.5 g of medium RDA gel to foam toothpaste (Toothpaste 2) containing 1450 ppm F as NaF and 5% w/w KNO3; 1.5 g of Marketed toothpaste (Toothpaste 3) containing 1450 ppm F as NaF and 5% w/w KNO3; and 1.5 g of placebo toothpaste containing no fluoride but 5% w/w KNO3. There was a washout period of 2 days following each treatment session. In this washout period, participants used a non-fluoridated toothpaste to ensure no carry over effect.
128882|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.
128883|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128884|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128885|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128886|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
128887|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128888|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128889|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128890|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.
144841|NCT01588561|O1|Outcome|Nicotine|Intravenous Nicotine (1.5 mg/70 kg)
128891|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128892|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128893|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128894|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
128895|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128896|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128897|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128898|NCT01657903|E4|Reported Event|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
128899|NCT01657903|E3|Reported Event|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128900|NCT01657903|E2|Reported Event|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
128901|NCT01657903|E1|Reported Event|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 parts per million of fluoride as NaF and 5% w/w KNO3.
128902|NCT01657877|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics.
128903|NCT01657877|P1|Participant Flow|Overall Participants|"In this cross-over study, participant partial dentures were modified to hold two enamel specimens. Denture was modified at the start of the first treatment period to hold the enamel specimens. The participants were randomized using a computer generated program to receive following dentifrices:
Dentifrice containing 1500 parts per million (ppm) as sodium monofluorophosphate (SMFP) + 5% calcium sodium phosphosilicate (CSP)
Dentifrice containing 1500 ppm fluoride as SMFP + 0% CSP
Dentifrice containing 500 ppm fluoride as SMFP + 0% CSP
Dentifrice containing 0 ppm fluoride + 0% CSP
Dentifrice containing 0 ppm fluoride + 5% CSP. The participants applied the given dentifrice as per their treatment group to a toothbrush and brushed their natural teeth twice daily for one timed minute. There was a washout period of 6 days between each treatment period."
128904|NCT01657877|O2|Outcome|Dentifrice Containing 1500ppm Fluoride as SMFP + 5 % CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128905|NCT01657877|O1|Outcome|Dentifrice Containing 1500ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128906|NCT01657877|O5|Outcome|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128907|NCT01657877|O4|Outcome|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128908|NCT01657877|O3|Outcome|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128909|NCT01657877|O2|Outcome|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128910|NCT01657877|O1|Outcome|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128911|NCT01657877|O3|Outcome|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128912|NCT01657877|O2|Outcome|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128913|NCT01657877|O1|Outcome|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128914|NCT01657877|E5|Reported Event|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128915|NCT01657877|E4|Reported Event|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128916|NCT01657877|E3|Reported Event|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128917|NCT01657877|E2|Reported Event|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128918|NCT01657877|E1|Reported Event|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
128919|NCT01657461|B3|Baseline|Total|Total of all reporting groups
128921|NCT01657461|B1|Baseline|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128922|NCT01657461|P2|Participant Flow|IV t-PA|IV infusion of tPA
128923|NCT01657461|P1|Participant Flow|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128924|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
128925|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128926|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
128927|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128928|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
128929|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128930|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
128931|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128932|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
129166|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
128933|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128934|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
128935|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128936|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
128937|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128938|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
128939|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128940|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
128941|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128942|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
128943|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128944|NCT01657461|E2|Reported Event|IV t-PA|IV infusion of tPA
128945|NCT01657461|E1|Reported Event|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
128946|NCT01657370|B7|Baseline|Total|Total of all reporting groups
128947|NCT01657370|B6|Baseline|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128948|NCT01657370|B5|Baseline|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128949|NCT01657370|B4|Baseline|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128950|NCT01657370|B3|Baseline|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128951|NCT01657370|B2|Baseline|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128952|NCT01657370|B1|Baseline|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128953|NCT01657370|P6|Participant Flow|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128954|NCT01657370|P5|Participant Flow|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128955|NCT01657370|P4|Participant Flow|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128956|NCT01657370|P3|Participant Flow|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128957|NCT01657370|P2|Participant Flow|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128958|NCT01657370|P1|Participant Flow|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128959|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128960|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128961|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128962|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128963|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128964|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128965|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128966|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128967|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128968|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128969|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128970|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128971|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128972|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128973|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128974|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128975|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128976|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128977|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128978|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128979|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128980|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128981|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128982|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128983|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128984|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128985|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128986|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128987|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129154|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
128988|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128989|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128990|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128991|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128992|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128993|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128994|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128995|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128996|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128997|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128998|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
128999|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129000|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129001|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129002|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129003|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129004|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129005|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129006|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129007|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129008|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129009|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129010|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129011|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129012|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129013|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
144842|NCT01588561|E2|Reported Event|Saline|Saline infusion
129014|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129015|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129016|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129017|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129018|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129019|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129020|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129021|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129022|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129023|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129024|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129025|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129026|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129027|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129028|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129029|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129030|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129031|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129032|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129033|NCT01657370|E6|Reported Event|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129034|NCT01657370|E5|Reported Event|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129035|NCT01657370|E4|Reported Event|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129036|NCT01657370|E3|Reported Event|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129037|NCT01657370|E2|Reported Event|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129038|NCT01657370|E1|Reported Event|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
129039|NCT01657292|B1|Baseline|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
129040|NCT01657292|P1|Participant Flow|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
129041|NCT01657292|O1|Outcome|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
129042|NCT01657292|E4|Reported Event|Localized AE Both Wound Halves|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred at both the Octenilin® wound half and Oleogel-S10 wound half in one patient are reported under this arm.
129043|NCT01657292|E3|Reported Event|Octenilin Localized AE|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Octenilin® wound half are reported under this arm.
129044|NCT01657292|E2|Reported Event|Oleogel-S10 Localized AE|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Oleogel-S10 wound half are reported under this arm.
129045|NCT01657292|E1|Reported Event|Entire Study Population - Systemic AEs|All patients treated with Oleogel-S10 and Octenilin® wound gel. Systemic AEs which are not localized to the wound application site are reported under this arm.
129046|NCT01657032|B3|Baseline|Total|Total of all reporting groups
129167|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129168|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129047|NCT01657032|B2|Baseline|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129048|NCT01657032|B1|Baseline|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129049|NCT01657032|P2|Participant Flow|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129050|NCT01657032|P1|Participant Flow|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129051|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129052|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129053|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129054|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129055|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129056|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129057|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129155|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129156|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129058|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129059|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129169|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129060|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129061|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129062|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129063|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129064|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129065|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129066|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129067|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129068|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129069|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129070|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129088|NCT01656967|B2|Baseline|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use"
129157|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129071|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129072|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129073|NCT01657032|E2|Reported Event|Lactobacillus GG and Placebo|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129074|NCT01657032|E1|Reported Event|Lactobacillus GG and Smectite|"Children received:
LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
129075|NCT01657019|B1|Baseline|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129076|NCT01657019|P1|Participant Flow|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129077|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129078|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129079|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129080|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129081|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129082|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129083|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129084|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129085|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129086|NCT01657019|E1|Reported Event|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
129087|NCT01656967|B3|Baseline|Total|Total of all reporting groups
129089|NCT01656967|B1|Baseline|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
129090|NCT01656967|P2|Participant Flow|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use"
129091|NCT01656967|P1|Participant Flow|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
129092|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use"
129093|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
129094|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
first-attempt success rate for SGA placement for the ILMA group (30/33, 90.9%, P = 1.0)"
129095|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
first-attempt success rate for SGA placement for the Aura-i group (30/33, 90.9%)"
129096|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
first-attempt success rate for SGA placement for the ILMA group (30/33, 90.9%, P = 1.0)"
129097|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
first-attempt success rate for SGA placement for the Aura-i group (30/33, 90.9%)"
129098|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use"
129099|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
129100|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use"
129101|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
129102|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use"
129103|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
129104|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use"
129105|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
129106|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use"
129107|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
129108|NCT01656967|E2|Reported Event|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use"
129109|NCT01656967|E1|Reported Event|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
129110|NCT01656889|B3|Baseline|Total|Total of all reporting groups
129111|NCT01656889|B2|Baseline|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)
Vehicle"
129112|NCT01656889|B1|Baseline|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
129113|NCT01656889|P2|Participant Flow|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)
Vehicle"
129114|NCT01656889|P1|Participant Flow|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
129115|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)
Vehicle"
144843|NCT01588561|E1|Reported Event|Nicotine|Nicotine infusion
129116|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
129117|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)
Vehicle"
129170|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129171|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129172|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129173|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129118|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
129119|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)
Vehicle"
129120|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
129121|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)
Vehicle"
129122|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
129123|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)
Vehicle"
129124|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
129125|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)
Vehicle"
129126|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
129127|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)
Vehicle"
129128|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
129129|NCT01656889|E2|Reported Event|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)
Vehicle"
129130|NCT01656889|E1|Reported Event|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
129131|NCT01656850|B3|Baseline|Total|Total of all reporting groups
129132|NCT01656850|B2|Baseline|NCEP Diet First, Then Almond Diet|"follow NCEP step 2 diet
NCEP Step 2 diet: follow NCEP step 2 diet"
129133|NCT01656850|B1|Baseline|Almond Diet First, Then NCEP Diet|"whole almonds to replace 20% daily calorie intake
whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
129134|NCT01656850|P2|Participant Flow|NCEP Diet First, Then Whole Almonds Diet|run in 2 weeks, NCEP diet Intervention (3 months), Washout (2 weeks), whole almonds Intervention (3 months)
129135|NCT01656850|P1|Participant Flow|Whole Almonds First, Then NCEP Diet|run in 2 weeks, whole almonds diet Intervention (3 months), Washout (2 weeks), and then NCEP diet Intervention (3 months)
129136|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129137|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129138|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129139|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129140|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129141|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129142|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129143|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129144|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129145|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129146|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129147|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129148|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129149|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129150|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129151|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129158|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129159|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129160|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129161|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129162|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129163|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129164|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129176|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129177|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129178|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129179|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129180|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129181|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129182|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129183|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129184|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129185|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129186|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129187|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129188|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129189|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129190|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129191|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129192|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129193|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129194|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129195|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129196|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129197|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129198|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129199|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129200|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet
NCEP Step 2 diet: follow NCEP step 2 diet"
129201|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake
whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
129202|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet
NCEP Step 2 diet: follow NCEP step 2 diet"
129203|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake
whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
129204|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
129205|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
129206|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
129207|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
129208|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet
NCEP Step 2 diet: follow NCEP step 2 diet"
129209|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake
whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
129210|NCT01656850|E2|Reported Event|NCEP Diet|participants received NCEP diet for 3 months
129211|NCT01656850|E1|Reported Event|Whole Almond Diet|participants received experiment diet containing 20% calorie from whole almond
129212|NCT01656772|B3|Baseline|Total|Total of all reporting groups
129213|NCT01656772|B2|Baseline|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter
Vdrive Lasso navigation: Remote robotic Lasso navigation"
129214|NCT01656772|B1|Baseline|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter
Manual Lasso navigation: Manually maneuver a Lasso catheter"
129215|NCT01656772|P2|Participant Flow|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter
Vdrive Lasso navigation: Remote robotic Lasso navigation"
129216|NCT01656772|P1|Participant Flow|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter
Manual Lasso navigation: Manually maneuver a Lasso catheter"
129217|NCT01656772|O2|Outcome|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter
Vdrive Lasso navigation: Remote robotic Lasso navigation"
129218|NCT01656772|O1|Outcome|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter
Manual Lasso navigation: Manually maneuver a Lasso catheter"
129305|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
129219|NCT01656772|O2|Outcome|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter
Vdrive Lasso navigation: Remote robotic Lasso navigation"
129220|NCT01656772|O1|Outcome|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter
Manual Lasso navigation: Manually maneuver a Lasso catheter"
129221|NCT01656772|E2|Reported Event|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter
Vdrive Lasso navigation: Remote robotic Lasso navigation"
129222|NCT01656772|E1|Reported Event|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter
Manual Lasso navigation: Manually maneuver a Lasso catheter"
129223|NCT01656759|B3|Baseline|Total|Total of all reporting groups
129224|NCT01656759|B2|Baseline|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
129225|NCT01656759|B1|Baseline|Control Group|Control group. Will not receive the fibrin spray.
129226|NCT01656759|P2|Participant Flow|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
129227|NCT01656759|P1|Participant Flow|Control Group|Control group. Will not receive the fibrin spray.
129228|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
129229|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
129230|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
129231|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
129232|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
129233|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
129234|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
129235|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
129236|NCT01656759|E2|Reported Event|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
129237|NCT01656759|E1|Reported Event|Control Group|Control group. Will not receive the fibrin spray.
129238|NCT01656486|B1|Baseline|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.
Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
129239|NCT01656486|P1|Participant Flow|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.
Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
129240|NCT01656486|O1|Outcome|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.
Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
129241|NCT01656486|E1|Reported Event|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.
Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
129242|NCT01656460|B1|Baseline|Stereotactic Radiation|stereotactic
129243|NCT01656460|P4|Participant Flow|Stereotactic Radiation Dose Level 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
129244|NCT01656460|P3|Participant Flow|Stereotactic Radiation Dose Level 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
129245|NCT01656460|P2|Participant Flow|Stereotactic Radiation Dose Level 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
129246|NCT01656460|P1|Participant Flow|Stereotactic Radiation Dose Level 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose
1 8 Gy 16 Gy"
129247|NCT01656460|O4|Outcome|Arm 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
129248|NCT01656460|O3|Outcome|Arm 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
129249|NCT01656460|O2|Outcome|Arm 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
129250|NCT01656460|O1|Outcome|Arm 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose
1 8 Gy 16 Gy"
129251|NCT01656460|E4|Reported Event|Arm 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
129252|NCT01656460|E3|Reported Event|Arm 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
129253|NCT01656460|E2|Reported Event|Arm 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
129254|NCT01656460|E1|Reported Event|Arm 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose
1 8 Gy 16 Gy"
129255|NCT01656434|B3|Baseline|Total|Total of all reporting groups
129256|NCT01656434|B2|Baseline|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
129257|NCT01656434|B1|Baseline|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
129258|NCT01656434|P2|Participant Flow|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
129259|NCT01656434|P1|Participant Flow|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
129318|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129319|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
129260|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
129261|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
129262|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
129263|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
129264|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
129265|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
129266|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
129267|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
129268|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
129269|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
129270|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
129271|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
129272|NCT01656434|E2|Reported Event|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
129273|NCT01656434|E1|Reported Event|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
129274|NCT01656408|B11|Baseline|Total|Total of all reporting groups
129275|NCT01656408|B10|Baseline|Panel J – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
129276|NCT01656408|B9|Baseline|Panel I – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
129306|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129307|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
129277|NCT01656408|B8|Baseline|Panel H – Participants With Resistant Hypertension|In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
129278|NCT01656408|B7|Baseline|Panel G – Healthy Participants|8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
129279|NCT01656408|B6|Baseline|Panel F – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
129320|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129321|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
136577|NCT01627002|O3|Outcome|Part A PA401 1.0 mg|
129280|NCT01656408|B5|Baseline|Panel E – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
129281|NCT01656408|B4|Baseline|Panel D – Participants With Mild to Moderate Hypertension|5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
129282|NCT01656408|B3|Baseline|Panel C – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
129283|NCT01656408|B2|Baseline|Panel B – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
129284|NCT01656408|B1|Baseline|Panel A – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
129285|NCT01656408|P10|Participant Flow|Panel J – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
129286|NCT01656408|P9|Participant Flow|Panel I – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
129287|NCT01656408|P8|Participant Flow|Panel H – Participants With Resistant Hypertension|In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
129288|NCT01656408|P7|Participant Flow|Panel G – Healthy Participants|8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
129289|NCT01656408|P6|Participant Flow|Panel F – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
129290|NCT01656408|P5|Participant Flow|Panel E – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
129291|NCT01656408|P4|Participant Flow|Panel D – Participants With Mild to Moderate Hypertension|5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
129292|NCT01656408|P3|Participant Flow|Panel C – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
129293|NCT01656408|P2|Participant Flow|Panel B – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
129294|NCT01656408|P1|Participant Flow|Panel A – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
129295|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
129296|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129297|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
129298|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129299|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
129300|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129301|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
129302|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129303|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
129304|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129308|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129309|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
129310|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129311|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
129312|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129313|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
129314|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129315|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
129316|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129317|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
129322|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129323|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
129324|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129325|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
129326|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129327|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129328|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
129329|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129330|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
129331|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129332|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
129333|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129334|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
129335|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129336|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
129337|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129338|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
129339|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129340|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
129341|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129342|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
129343|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
129344|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129345|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129346|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129347|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129348|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
129349|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129350|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129351|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129352|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129353|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
129354|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129355|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129356|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129357|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129358|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
129359|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129360|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129361|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129362|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129363|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129364|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129365|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129366|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129367|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129368|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129369|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129370|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129371|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129372|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129373|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129374|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129479|NCT01656408|E3|Reported Event|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129375|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129376|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129377|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129378|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129379|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
129380|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
129381|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
129382|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
129383|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
129384|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
129385|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
129386|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
129387|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
129388|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
129389|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
129390|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
129391|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
129392|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
129393|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
129394|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
129395|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129396|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129397|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129398|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129399|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129400|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129401|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129402|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129403|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129404|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129405|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129406|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129407|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129408|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129409|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129410|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129411|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
129412|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129413|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
129414|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129415|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
129416|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129417|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
129418|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129419|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
129420|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129421|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
129422|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129423|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
129424|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129425|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
129480|NCT01656408|E2|Reported Event|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129426|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129427|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129428|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
129429|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129430|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
129431|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129432|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
129433|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
129434|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
129435|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
129436|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129437|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129438|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129439|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129440|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
129441|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129442|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129443|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129444|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129445|NCT01656408|O11|Outcome|Placebo (Panel A - J)|Combines participants who received placebo in all panels
129446|NCT01656408|O10|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129447|NCT01656408|O9|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129448|NCT01656408|O8|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129449|NCT01656408|O7|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129450|NCT01656408|O6|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
129451|NCT01656408|O5|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
129452|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129453|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129454|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129455|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129456|NCT01656408|O13|Outcome|Screening|All enrolled participants, presents AEs with onset before first dose of study drug
129457|NCT01656408|O12|Outcome|Post Study|All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug
129458|NCT01656408|O11|Outcome|Placebo (Panel A - J)|Combines participants who received placebo in all panels
129459|NCT01656408|O10|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129460|NCT01656408|O9|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129461|NCT01656408|O8|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129462|NCT01656408|O7|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129463|NCT01656408|O6|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
129464|NCT01656408|O5|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
129465|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129466|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
129467|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
129468|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129469|NCT01656408|E13|Reported Event|Screening|All enrolled participants, presents AEs with onset before first dose of study drug
129470|NCT01656408|E12|Reported Event|Post Study|All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug
129471|NCT01656408|E11|Reported Event|Placebo (Panel A - J)|Combines participants who received placebo in all panels
129472|NCT01656408|E10|Reported Event|Panel J – MK-8150 10/20 mgEdit|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
129473|NCT01656408|E9|Reported Event|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
129474|NCT01656408|E8|Reported Event|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
129475|NCT01656408|E7|Reported Event|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
129476|NCT01656408|E6|Reported Event|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
129477|NCT01656408|E5|Reported Event|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
129478|NCT01656408|E4|Reported Event|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
129481|NCT01656408|E1|Reported Event|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
129482|NCT01656304|B1|Baseline|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies"
129483|NCT01656304|P1|Participant Flow|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies"
129484|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies"
129485|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies"
129486|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies"
129487|NCT01656304|E1|Reported Event|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies"
129488|NCT01656252|B1|Baseline|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129489|NCT01656252|P1|Participant Flow|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129490|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129491|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129557|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
144844|NCT01588548|B7|Baseline|Total|Total of all reporting groups
129492|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129493|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
130718|NCT01650246|B1|Baseline|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
129494|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129495|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129496|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129497|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129498|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129499|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129542|NCT01655498|O2|Outcome|Subject Fit With the VBC Device [PP]|Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
129543|NCT01655498|O1|Outcome|Subjects Fit With the VBC Device [ITT]|ITT cohort is defined as all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period
129544|NCT01655498|E1|Reported Event|ITT Cohort [N=61]|Adverse Events reported during the Screening and 1-Month Treatment Period.
129545|NCT01655381|B1|Baseline|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129500|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129501|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129502|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129503|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129504|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129505|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129506|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129507|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129546|NCT01655381|P1|Participant Flow|Tocilizumab|Tocilizumab 8 milligrams per kilogram (mg/kg) administered intravenously once every 4 weeks during a minimum of 104 weeks.
129547|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks through Week 104.
129548|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks through Week 104.
129549|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129550|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129508|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129509|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129510|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129511|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129512|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129513|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129514|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129515|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.
Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.
Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129551|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129552|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129553|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129554|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129555|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
145064|NCT01587885|O1|Outcome|All Treated Participants|
129516|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129564|NCT01655381|E1|Reported Event|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129565|NCT01655329|B1|Baseline|Radiologists|Board Certified Radiologists
129595|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
129596|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
129597|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
129517|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129518|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129519|NCT01656252|E1|Reported Event|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
129520|NCT01656161|B1|Baseline|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
129521|NCT01656161|P1|Participant Flow|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
129522|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
129523|NCT01656161|O1|Outcome|PK/PD Subset of 15 Participants|Pharmacokinetic/pharmacodynamic subset of 15 participants who received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
129524|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
129525|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
129526|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
129527|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
129528|NCT01656161|O1|Outcome|PK/PD Subset|Pharmacokinetic/pharmacodynamic (PK/PD) subset of 15 participants included in the ITT analysis set.
129529|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
129530|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
129531|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
129532|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
129533|NCT01656161|E1|Reported Event|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
129534|NCT01656031|B1|Baseline|High-dose Cytarabine and Clofarabine|high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
129535|NCT01656031|P1|Participant Flow|High-dose Cytarabine and Clofarabine|high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
129536|NCT01656031|O1|Outcome|High-Dose Cytarabine and Clofarabine|
129537|NCT01656031|E1|Reported Event|High-Dose Cytarabine and Clofarabine|
129538|NCT01655498|B1|Baseline|All Subjects|All subjects who completed the fitting process (a screening criteria) and entered the treatment period.
129539|NCT01655498|P1|Participant Flow|All Subjects|All subjects who completed the fitting process and entered the treatment period, comprised the Intent-to-treat population.
129540|NCT01655498|O1|Outcome|ITT Cohort [N=61]|All subjects who entered the Treatment Period.
129541|NCT01655498|O1|Outcome|Subject Fit With the VBC Device [PP]|Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
129556|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129558|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129559|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129560|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129561|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129562|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129563|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
129566|NCT01655329|P1|Participant Flow|Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images. The radiologists reviewed each radiograph using one or the alternate presentation
129567|NCT01655329|O9|Outcome|Confidence on Tube Placement|The confirm image increases my confidence with respect to tube placement.
129568|NCT01655329|O8|Outcome|Need for Window/Level Manipulation|The standard image required less window/level manipulation
129569|NCT01655329|O7|Outcome|Confidence on Line Placement|The modified image increased my confidence with respect to line placement
129570|NCT01655329|O6|Outcome|Image Quality Radioopaque Regions|Image quality in the opaque image areas is superior on the confirm image
129571|NCT01655329|O5|Outcome|Overall Image Quality|Overall image quality is superior on the standard image
129572|NCT01655329|O4|Outcome|Cardiac Related Wires|Cardiac related wires are easier to see on the standard image
129573|NCT01655329|O3|Outcome|Venous Catheters|Venous catheters easier to see on modified image
129574|NCT01655329|O2|Outcome|Pleural Drain Visibility|Pleural drains are easier to see on the standard image.
129575|NCT01655329|O1|Outcome|Reading Time Estimate by Radiologists|The modified image will reduce reading time.
129576|NCT01655329|O2|Outcome|Modified Chest Radiographs|This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs. Each radiologist interpreted half the images as conventional images and half as processed images.
129577|NCT01655329|O1|Outcome|Standard Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images.
129578|NCT01655329|O2|Outcome|Modified Chest Radiographs|This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs. Each radiologist interpreted half the images as conventional images and half as processed images.
129579|NCT01655329|O1|Outcome|Standard Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images.
129580|NCT01655329|E1|Reported Event|Radiologists|
129581|NCT01655043|B1|Baseline|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
129582|NCT01655043|P1|Participant Flow|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
129583|NCT01655043|O1|Outcome|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
129584|NCT01655043|E1|Reported Event|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
129585|NCT01654887|B3|Baseline|Total|Total of all reporting groups
129586|NCT01654887|B2|Baseline|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
129587|NCT01654887|B1|Baseline|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
129588|NCT01654887|P2|Participant Flow|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
129616|NCT01654796|O4|Outcome|Phase 2 Sham LFMS|Participants in this group received Sham LFMS treatment for 2 days in Phase 2.
129589|NCT01654887|P1|Participant Flow|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
129590|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
129591|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
129592|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
129593|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
129594|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
130719|NCT01650246|P1|Participant Flow|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
129598|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
129599|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
129600|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
129601|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
129602|NCT01654887|E2|Reported Event|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
129603|NCT01654887|E1|Reported Event|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
129604|NCT01654861|B1|Baseline|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).
Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
129605|NCT01654861|P1|Participant Flow|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).
Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
129606|NCT01654861|O1|Outcome|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).
Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
129607|NCT01654861|O1|Outcome|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).
Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
129608|NCT01654861|E1|Reported Event|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).
Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
129609|NCT01654796|B4|Baseline|Total|Total of all reporting groups
129610|NCT01654796|B3|Baseline|Crossover Arm|"Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
129611|NCT01654796|B2|Baseline|Sham (LFMS)|"Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
129612|NCT01654796|B1|Baseline|Low Field Magnetic Stimulation|"Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression."
129613|NCT01654796|P3|Participant Flow|Sham LFMS First, Then Active LFMS|"Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
129614|NCT01654796|P2|Participant Flow|Sham (LFMS)|"Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
129615|NCT01654796|P1|Participant Flow|Low Field Magnetic Stimulation|"Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression."
129617|NCT01654796|O3|Outcome|Phase 2 Active LFMS|Participants in this group received Active LFMS treatment for 2 days in Phase 2.
129618|NCT01654796|O2|Outcome|Phase 1 Sham LFMS|Participants in this group received Sham LFMS treatment for 2 days in Phase 1.
129619|NCT01654796|O1|Outcome|Phase 1 Active LFMS|Participants in this group receive Active LFMS treatment for 2 days in Phase 1.
129620|NCT01654796|E3|Reported Event|Crossover Arm|"Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
129621|NCT01654796|E2|Reported Event|Sham (LFMS)|"Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation."
129637|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
136578|NCT01627002|O2|Outcome|Part A PA401 0.3 mg|
129622|NCT01654796|E1|Reported Event|Low Field Magnetic Stimulation|"Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression."
129623|NCT01654666|B4|Baseline|Total|Total of all reporting groups
129624|NCT01654666|B3|Baseline|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129625|NCT01654666|B2|Baseline|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129626|NCT01654666|B1|Baseline|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129627|NCT01654666|P3|Participant Flow|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129628|NCT01654666|P2|Participant Flow|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129629|NCT01654666|P1|Participant Flow|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129630|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129631|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129632|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129633|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129634|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129686|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129687|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129635|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129636|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
130720|NCT01650246|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
129638|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129639|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129640|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129641|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129642|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129643|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129644|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129645|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129646|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129647|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129648|NCT01654666|E3|Reported Event|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129649|NCT01654666|E2|Reported Event|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129688|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
130267|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
129650|NCT01654666|E1|Reported Event|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
129651|NCT01654601|B3|Baseline|Total|Total of all reporting groups
129652|NCT01654601|B2|Baseline|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
129653|NCT01654601|B1|Baseline|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
129654|NCT01654601|P2|Participant Flow|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
136579|NCT01627002|O1|Outcome|Part A PA401 0.1 mg|
129655|NCT01654601|P1|Participant Flow|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
129656|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
129657|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
129658|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
129659|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
129660|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
129661|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
129662|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
129663|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
129664|NCT01654601|E2|Reported Event|B Group|1.1st Administration - Clozaril tablet 100mg Mutiple dose 2.2nd Administration - DWCZP tablet 100mg Mutiple dose
129665|NCT01654601|E1|Reported Event|A Group|1.1st Administration - DWCZP tablet 100mg Mutiple dose 2.2nd Administration - Clozaril tablet 100mg Mutiple dose
129666|NCT01654549|B3|Baseline|Total|Total of all reporting groups
129667|NCT01654549|B2|Baseline|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
129668|NCT01654549|B1|Baseline|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
129669|NCT01654549|P2|Participant Flow|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
129670|NCT01654549|P1|Participant Flow|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
129671|NCT01654549|O6|Outcome|Liver Fat Content Change in Lifestyle Modification|The change of liver fat content from baseline to the end of study in lifestyle modification group
129672|NCT01654549|O5|Outcome|Liver Fat Content Change in H.Pylori Eradication|The change of liver fat content from baseline to the end of study in H.pylori eradication group
129673|NCT01654549|O4|Outcome|Liver Fat Content in Lifestyle Modification at 8 Weeks|Liver fat content in lifestyle modification group at 8 weeks
129674|NCT01654549|O3|Outcome|Liver Fat Content in Lifestyle Modification at Baseline|Liver fat content in lifestyle modification group at baseline
129675|NCT01654549|O2|Outcome|Liver Fat Content in H.Pylori Eradication at 8 Weeks|Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at 8 weeks
129676|NCT01654549|O1|Outcome|Liver Fat Content in H.Pylori Eradication at Baseline|Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at baseline
129677|NCT01654549|E2|Reported Event|No Intervention|Lifestyle modification
129678|NCT01654549|E1|Reported Event|H. Pylori Eradication|Helicobacter pylori eradication
129679|NCT01654536|B3|Baseline|Total|Total of all reporting groups
129680|NCT01654536|B2|Baseline|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129681|NCT01654536|B1|Baseline|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129682|NCT01654536|P2|Participant Flow|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129683|NCT01654536|P1|Participant Flow|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129684|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129685|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129689|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129690|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129691|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129692|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129693|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129805|NCT01654224|P1|Participant Flow|HD IIV|Frail adults 65 years or older who received Fluzone High Dose intramuscularly.
129694|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129695|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129696|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129697|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129698|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129699|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129700|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129701|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129702|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129703|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129704|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129705|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetona (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129706|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129707|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129708|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129709|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129710|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129711|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129712|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129713|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129714|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129715|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129716|NCT01654536|E2|Reported Event|Ciclesonide Nasal Spray|"ciclesonide nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
129717|NCT01654536|E1|Reported Event|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
129718|NCT01654523|B1|Baseline|Treatment Arm|"Open trial with no randomization
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
129719|NCT01654523|P1|Participant Flow|Awareness Enhancement and Monitoring Device|"Open trial with no randomization
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
129720|NCT01654523|O1|Outcome|Awareness Enhancement and Monitoring Device|"Open trial with no randomization
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
129721|NCT01654523|E1|Reported Event|Treatment Arm|"Open trial with no randomization
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
129722|NCT01654302|B3|Baseline|Total|Total of all reporting groups
129723|NCT01654302|B2|Baseline|Placebo Then Synera|Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
129724|NCT01654302|B1|Baseline|Synera Then Placebo|Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch (placebo) at the Second Intervention (Day 7).
129725|NCT01654302|P2|Participant Flow|Placebo Then Synera|Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
129726|NCT01654302|P1|Participant Flow|Synera Then Placebo|Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch at the Second Intervention (Day 7).
129727|NCT01654302|O2|Outcome|Inactive Patch|placebo: placebo
129728|NCT01654302|O1|Outcome|Synera|70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
129729|NCT01654302|E2|Reported Event|Inactive Patch|placebo: placebo
129730|NCT01654302|E1|Reported Event|Synera|70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
129731|NCT01654276|B1|Baseline|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129732|NCT01654276|P1|Participant Flow|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129733|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129734|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129735|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129736|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129737|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129738|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129739|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129740|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129741|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129742|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129743|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129744|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129745|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129746|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129747|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129748|NCT01654276|E1|Reported Event|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.
Febuxostat: One 40 mg tablet once a day for 6 months"
129749|NCT01654263|B7|Baseline|Total|Total of all reporting groups
129750|NCT01654263|B6|Baseline|IIBB: Age 65-74, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129863|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129751|NCT01654263|B5|Baseline|IIAA: Age 55-64, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129752|NCT01654263|B4|Baseline|IIB: Age 65-74, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129753|NCT01654263|B3|Baseline|IIA: Age 55-64, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129754|NCT01654263|B2|Baseline|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
129755|NCT01654263|B1|Baseline|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
129756|NCT01654263|P6|Participant Flow|IIBB: Age 65 - 74, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129757|NCT01654263|P5|Participant Flow|IIAA: Age 55-64, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129758|NCT01654263|P4|Participant Flow|IIB: Age 65-74, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129759|NCT01654263|P3|Participant Flow|IIA: Age 55-64, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129760|NCT01654263|P2|Participant Flow|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
129761|NCT01654263|P1|Participant Flow|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
129762|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129763|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129764|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
129765|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129766|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129767|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
129768|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129769|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129770|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
129771|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129772|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129773|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
129774|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129775|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129776|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
129828|NCT01653782|P2|Participant Flow|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise
Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
129777|NCT01654263|E6|Reported Event|IIBB: Previous PPSV23, Age 65-74, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129778|NCT01654263|E5|Reported Event|IIAA: Previous PPSV23, Age 55-64, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129779|NCT01654263|E4|Reported Event|IIB: Previous PPSV23, Age 65-74, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129867|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129780|NCT01654263|E3|Reported Event|IIA: Previous PPSV23, Age 55-64, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
129781|NCT01654263|E2|Reported Event|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
129782|NCT01654263|E1|Reported Event|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
129783|NCT01654250|B3|Baseline|Total|Total of all reporting groups
129784|NCT01654250|B2|Baseline|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129785|NCT01654250|B1|Baseline|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129786|NCT01654250|P2|Participant Flow|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129787|NCT01654250|P1|Participant Flow|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129788|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129789|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129790|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129791|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129792|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129793|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129794|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129795|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129796|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129797|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129798|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129799|NCT01654250|E2|Reported Event|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129829|NCT01653782|P1|Participant Flow|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
129800|NCT01654250|E1|Reported Event|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
129801|NCT01654224|B3|Baseline|Total|Total of all reporting groups
129802|NCT01654224|B2|Baseline|SD IIV|Frail adults 65 years and older who received Fluzone Standard Dose intramuscularly
129803|NCT01654224|B1|Baseline|HD IIV|Frail adults 65 years and older who received Fluzone High Dose intramuscularly
129804|NCT01654224|P2|Participant Flow|SD IIV|Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
136580|NCT01627002|E9|Reported Event|Part B Placebo|
129806|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin
Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
129807|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin
High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
129808|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin
Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
129809|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin
High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
129810|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin
Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
129811|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin
High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
129812|NCT01654224|E2|Reported Event|SD IIV|Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
129813|NCT01654224|E1|Reported Event|HD IIV|Frail adults 65 years or older who received Fluzone High Dose intramuscularly.
129814|NCT01654107|B3|Baseline|Total|Total of all reporting groups
129815|NCT01654107|B2|Baseline|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
129816|NCT01654107|B1|Baseline|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)
Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
129817|NCT01654107|P2|Participant Flow|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
129818|NCT01654107|P1|Participant Flow|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)
Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
129819|NCT01654107|O2|Outcome|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
129820|NCT01654107|O1|Outcome|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)
Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
129821|NCT01654107|E2|Reported Event|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
129822|NCT01654107|E1|Reported Event|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)
Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
129823|NCT01653782|B4|Baseline|Total|Total of all reporting groups
129824|NCT01653782|B3|Baseline|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 2 hours, twice a week for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
129825|NCT01653782|B2|Baseline|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise
Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
129826|NCT01653782|B1|Baseline|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
129827|NCT01653782|P3|Participant Flow|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes of intructor-led yoga each week) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
129861|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129830|NCT01653782|O3|Outcome|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes each week of instructor-led yoga) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
129831|NCT01653782|O2|Outcome|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise
Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
129832|NCT01653782|O1|Outcome|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
129833|NCT01653782|E3|Reported Event|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for twice a week for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
136581|NCT01627002|E8|Reported Event|Part B PA401 3.0 mg|
129834|NCT01653782|E2|Reported Event|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise
Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
129835|NCT01653782|E1|Reported Event|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
129836|NCT01653743|B3|Baseline|Total|Total of all reporting groups
129837|NCT01653743|B2|Baseline|Urinary Human Chorionic Gonadotropin (u-hCG)|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
129838|NCT01653743|B1|Baseline|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
129839|NCT01653743|P2|Participant Flow|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
129840|NCT01653743|P1|Participant Flow|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
129841|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
129842|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
129843|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
129844|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
129862|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
145148|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
129845|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
129868|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129846|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
129847|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
129848|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
129849|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
129850|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
129851|NCT01653743|E2|Reported Event|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
129852|NCT01653743|E1|Reported Event|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
129853|NCT01653509|B3|Baseline|Total|Total of all reporting groups
129854|NCT01653509|B2|Baseline|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population.
129855|NCT01653509|B1|Baseline|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population.
129856|NCT01653509|P2|Participant Flow|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129857|NCT01653509|P1|Participant Flow|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129858|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area at a time. A maximum of 5 patches/ day were allowed during the 10 day study period.
129859|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area at a time. A maximum of 5 patches/ day were allowed during the 10 day study period.
129860|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
130268|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
129864|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129865|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129866|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129869|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129870|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129871|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
129872|NCT01653509|E2|Reported Event|Placebo Patch|Participants applied single placebo patch to the cold sore area.
129873|NCT01653509|E1|Reported Event|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area.
129874|NCT01653418|B1|Baseline|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129875|NCT01653418|P1|Participant Flow|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129876|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129877|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129878|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129879|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129880|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129881|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129882|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129883|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129884|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129885|NCT01653418|E1|Reported Event|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
129886|NCT01653262|B1|Baseline|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129887|NCT01653262|P1|Participant Flow|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129888|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129889|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129890|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
130721|NCT01650246|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
129891|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129892|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129893|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129894|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129895|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129896|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129897|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129898|NCT01653262|E1|Reported Event|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
129899|NCT01653158|B1|Baseline|Entire Study Population|Includes all enrolled participants who received single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously at each cycle (1 cycle = 21 days).
129900|NCT01653158|P8|Participant Flow|CP-751,871 20 mg/kg + Docetaxel|"In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days).
In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1."
129901|NCT01653158|P7|Participant Flow|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129902|NCT01653158|P6|Participant Flow|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129903|NCT01653158|P5|Participant Flow|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129904|NCT01653158|P4|Participant Flow|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129905|NCT01653158|P3|Participant Flow|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129906|NCT01653158|P2|Participant Flow|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129907|NCT01653158|P1|Participant Flow|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129908|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129909|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129910|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130275|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
129911|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129912|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129913|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129914|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129915|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129916|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129917|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129918|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129919|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129920|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129921|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129922|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129923|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129924|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129925|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129926|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129927|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129928|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129929|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129930|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129931|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129932|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129933|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129934|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129935|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129936|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129937|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129938|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129939|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129940|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129941|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129942|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129943|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129944|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129945|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129946|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129947|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129948|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129949|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129950|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129951|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129952|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129953|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129954|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129955|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129956|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129957|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129958|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129959|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129960|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129961|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129962|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129963|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129964|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129965|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129966|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129967|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129968|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129969|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129970|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129971|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129972|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129973|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129974|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129975|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129976|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129977|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129978|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129979|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129980|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129981|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129982|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129983|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129984|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129985|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129986|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129987|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129988|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129989|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129990|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129991|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129992|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129993|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129994|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129995|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
129996|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129997|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129998|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
129999|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130000|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130001|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130002|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130003|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130004|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130005|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130006|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130007|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130008|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130009|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130010|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130011|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130012|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130013|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130014|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130015|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130016|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130017|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130018|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130019|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130020|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130021|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130022|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130023|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130024|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130025|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130026|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130027|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130028|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130029|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130030|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130031|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130032|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130033|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130034|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130035|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130036|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130037|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130038|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130039|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130040|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130041|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130042|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130043|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130044|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130045|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130046|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130047|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130048|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130049|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130050|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130051|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130052|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130053|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130054|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130055|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130056|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130057|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130058|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130059|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130060|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130061|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130062|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130063|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130064|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130065|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130066|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130067|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130068|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130069|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130070|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130071|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130072|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130073|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130074|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130075|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130076|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130077|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130078|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130079|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130080|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130081|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130082|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130083|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130084|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130085|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130086|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130087|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130088|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130089|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130090|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130091|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130092|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130093|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130094|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130095|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130096|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130097|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130098|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130099|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130100|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130101|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130102|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130103|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130104|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130105|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130106|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130107|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130108|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130109|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130110|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130111|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130112|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130113|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130114|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130115|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130116|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130117|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130118|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130119|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130120|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130121|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130122|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130123|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130124|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
130125|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130126|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130127|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130128|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130129|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130130|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130131|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130132|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
130133|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130134|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130135|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130136|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130137|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130138|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130139|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130140|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
130141|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130142|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130143|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130144|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130145|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130146|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130147|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130148|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
130149|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130150|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130151|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130152|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130153|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130154|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130155|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130156|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130175|NCT01653158|E3|Reported Event|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130276|NCT01652729|E3|Reported Event|Placebo Comparator: Placebo|Placebo oral tablet once daily
130157|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130158|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130159|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130160|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130161|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130162|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130163|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130164|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130165|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130166|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130167|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
130168|NCT01653158|O1|Outcome|CP-751,871 0.1-20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
130169|NCT01653158|O1|Outcome|CP-751,871 0.1-20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130170|NCT01653158|E8|Reported Event|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
130171|NCT01653158|E7|Reported Event|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130172|NCT01653158|E6|Reported Event|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130173|NCT01653158|E5|Reported Event|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130174|NCT01653158|E4|Reported Event|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130206|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130176|NCT01653158|E2|Reported Event|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
130177|NCT01653158|E1|Reported Event|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
130178|NCT01653132|B1|Baseline|All Study Participants|Participants who received either Placebo, 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each) and submandibular ( 0.3 ml each), or Incobotulinum Toxin A 100 units, 20 units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
130179|NCT01653132|P2|Participant Flow|Incobotulinum Toxin A First, Then Placebo|Incobotulinum toxin, 100 units, diluted in 1 ml 0.9% sterile saline. 20 units (0.2 ml) were injected into each parotid gland and 30 units (0.3 ml) into each submandibular gland using anatomical landmarks
130180|NCT01653132|P1|Participant Flow|Placebo First, Then Incobotulinum Toxin A|sterile, preservative free 0.9% saline, 1 ml of saline into the parotid and submandibular glands in first intervention period
130181|NCT01653132|O2|Outcome|Placebo|Placebo: 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each)and submandibular ( 0.3ml each) glands of subjects
130182|NCT01653132|O1|Outcome|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each)and submandibular (30 units, 0.3ml each) glands of subjects
130183|NCT01653132|O2|Outcome|Placebo|"Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
Placebo: Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands ."
130184|NCT01653132|O1|Outcome|Incobotulinum Toxin A|"Twenty units (0.2 ml) of incobotulinum toxin A injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks
Incobotulinum Toxin A: Twenty units (0.2 ml) of incobotulinum toxin A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks"
130185|NCT01653132|O2|Outcome|Placebo|Placebo: 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each)and submandibular ( 0.3ml each) glands of subjects
130186|NCT01653132|O1|Outcome|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each)and submandibular (30 units, 0.3ml each) glands of subjects
130187|NCT01653132|O2|Outcome|Incobotulinum Toxin A|Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
130188|NCT01653132|O1|Outcome|Placebo|Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
130189|NCT01653132|O2|Outcome|Incobotulinum Toxin A|Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
130190|NCT01653132|O1|Outcome|Placebo|Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
130191|NCT01653132|E2|Reported Event|Placebo|Sterile, preservative free 0.9% saline, 1 mL injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
130192|NCT01653132|E1|Reported Event|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each) and submandibular (30 units, 0.3ml each) glands of subjects
130193|NCT01653028|B6|Baseline|Total|Total of all reporting groups
130194|NCT01653028|B5|Baseline|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130195|NCT01653028|B4|Baseline|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130196|NCT01653028|B3|Baseline|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130197|NCT01653028|B2|Baseline|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130198|NCT01653028|B1|Baseline|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130199|NCT01653028|P5|Participant Flow|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130200|NCT01653028|P4|Participant Flow|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130201|NCT01653028|P3|Participant Flow|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130202|NCT01653028|P2|Participant Flow|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130203|NCT01653028|P1|Participant Flow|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130521|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
130204|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130205|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130274|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
130207|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130208|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130209|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130210|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130211|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130212|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130213|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130214|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130215|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130216|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130217|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130218|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130219|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130220|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130221|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130222|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130223|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130224|NCT01653028|E5|Reported Event|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130225|NCT01653028|E4|Reported Event|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130226|NCT01653028|E3|Reported Event|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130227|NCT01653028|E2|Reported Event|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130228|NCT01653028|E1|Reported Event|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
130229|NCT01652885|B1|Baseline|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130230|NCT01652885|P1|Participant Flow|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate atopic dermatitis (AD), twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130231|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130232|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130233|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130234|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130266|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
130235|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130236|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130237|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130238|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130239|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130240|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130241|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130242|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130243|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130244|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130245|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130246|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130247|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130248|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130249|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130250|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130251|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130252|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130253|NCT01652885|E1|Reported Event|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
130254|NCT01652729|B4|Baseline|Total|Total of all reporting groups
130255|NCT01652729|B3|Baseline|Placebo Comparator: Placebo|Placebo oral tablet once daily
130256|NCT01652729|B2|Baseline|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
130257|NCT01652729|B1|Baseline|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
130258|NCT01652729|P3|Participant Flow|Placebo Comparator: Placebo|Placebo oral tablet once daily
130259|NCT01652729|P2|Participant Flow|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
130260|NCT01652729|P1|Participant Flow|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
130261|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
130262|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
130263|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
130264|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
130265|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
130269|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
130270|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
130271|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
130272|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
130273|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
130277|NCT01652729|E2|Reported Event|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
130278|NCT01652729|E1|Reported Event|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
130279|NCT01652716|B3|Baseline|Total|Total of all reporting groups
130280|NCT01652716|B2|Baseline|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
130281|NCT01652716|B1|Baseline|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
130282|NCT01652716|P2|Participant Flow|Active Comparator: Exenatide Twice Daily (BID)|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
130283|NCT01652716|P1|Participant Flow|Experimental: Exenatide Once Weekly (QWS) Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
130284|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
130285|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
130286|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
130287|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
130288|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
130289|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
130290|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
130291|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
130292|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
130293|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
130294|NCT01652716|E2|Reported Event|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
130295|NCT01652716|E1|Reported Event|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
130296|NCT01652703|B7|Baseline|Total|Total of all reporting groups
130297|NCT01652703|B6|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130298|NCT01652703|B5|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130299|NCT01652703|B4|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130300|NCT01652703|B3|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130301|NCT01652703|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
130302|NCT01652703|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
130303|NCT01652703|P6|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130304|NCT01652703|P5|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130305|NCT01652703|P4|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130306|NCT01652703|P3|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130307|NCT01652703|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
130308|NCT01652703|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
130309|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130310|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130311|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130312|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130313|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
130314|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
130315|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130316|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130866|NCT01649232|B2|Baseline|Controls|Healthy people that not receive tDCS
130317|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130318|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130319|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
130320|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
130321|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130322|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130323|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130324|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130325|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
130326|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
130327|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130328|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130329|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130330|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130331|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
130332|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
130333|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130334|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130335|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130336|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130337|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
130338|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
130339|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130340|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130341|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130342|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130343|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
130344|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
130345|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130346|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130347|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130348|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130349|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
130350|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
130351|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130352|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130353|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130354|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130355|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
130356|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
130357|NCT01652703|E6|Reported Event|Evolocumab Q4W 420 MG|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130358|NCT01652703|E5|Reported Event|Evolocumab Q4W 280 MG|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
130359|NCT01652703|E4|Reported Event|Evolocumab Q2W 140 MG|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130360|NCT01652703|E3|Reported Event|Evolocumab Q2W 70 MG|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
130361|NCT01652703|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
130362|NCT01652703|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
130363|NCT01652690|B3|Baseline|Total|Total of all reporting groups
130364|NCT01652690|B2|Baseline|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130365|NCT01652690|B1|Baseline|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130366|NCT01652690|P2|Participant Flow|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130442|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130367|NCT01652690|P1|Participant Flow|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130368|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130369|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130370|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130371|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130372|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130373|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130374|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130375|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130376|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130377|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130378|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130379|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130380|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130381|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130382|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130383|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130384|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130385|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130386|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130387|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130388|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130389|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130390|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130391|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130392|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130393|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130394|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130395|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130396|NCT01652690|E2|Reported Event|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
136582|NCT01627002|E7|Reported Event|Part B PA401 1.0 mg|
130397|NCT01652690|E1|Reported Event|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
130398|NCT01652664|B3|Baseline|Total|Total of all reporting groups
130399|NCT01652664|B2|Baseline|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
130400|NCT01652664|B1|Baseline|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
130401|NCT01652664|P2|Participant Flow|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
130402|NCT01652664|P1|Participant Flow|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
130403|NCT01652664|O2|Outcome|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
130404|NCT01652664|O1|Outcome|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
130405|NCT01652664|E3|Reported Event|Timolol|All participants who received timolol; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
130406|NCT01652664|E2|Reported Event|Travoprost|All participants who received travoprost with vehicle
130407|NCT01652664|E1|Reported Event|Pre-Treatment|All enrolled participants
130408|NCT01652573|B3|Baseline|Total|Total of all reporting groups
130409|NCT01652573|B2|Baseline|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130410|NCT01652573|B1|Baseline|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130411|NCT01652573|P2|Participant Flow|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130412|NCT01652573|P1|Participant Flow|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130413|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130414|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130415|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130416|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130417|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130418|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130419|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130420|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130421|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130422|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130423|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130424|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130425|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130426|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130427|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130428|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130429|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130430|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130431|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130432|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130433|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130434|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130435|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130436|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130437|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130438|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130439|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130440|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130441|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
136583|NCT01627002|E6|Reported Event|Part A Placebo|
130443|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130444|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130445|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130446|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130447|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130448|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130449|NCT01652573|E2|Reported Event|Saline Nasal Spray|"Patients will receive saline nasal spray once daily
Saline Nasal Spray Placebo"
130450|NCT01652573|E1|Reported Event|Nasal Calictonin|"Subjects will received nasal calcitonin once daily
nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
130451|NCT01652495|B3|Baseline|Total|Total of all reporting groups
130452|NCT01652495|B2|Baseline|Triamcinolone Acetonide|Single intrabursal injection of 40 mg (1 ml) of trimacinolone acetonide
130453|NCT01652495|B1|Baseline|Methylprednisolone Acetate|Single intrabursal injection of 40 mg (1 ml) of methylprednisolone acetate
130454|NCT01652495|P2|Participant Flow|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide
Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
130455|NCT01652495|P1|Participant Flow|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate
methylprednisolone acetate: Single intrabursal ultrasound guided injection"
130456|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide
Triamcinolone Acetonide: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide"
130457|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate
methylprednisolone acetate: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate"
130458|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide
Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
130459|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate
methylprednisolone acetate: Single intrabursal ultrasound guided injection"
130460|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide
Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
130461|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate
methylprednisolone acetate: Single intrabursal ultrasound guided injection"
130462|NCT01652495|E2|Reported Event|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide
Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
130463|NCT01652495|E1|Reported Event|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate
methylprednisolone acetate: Single intrabursal ultrasound guided injection"
130464|NCT01652287|B3|Baseline|Total|Total of all reporting groups
130465|NCT01652287|B2|Baseline|Control|yogurt cultured with starter YF-L702
130466|NCT01652287|B1|Baseline|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
130467|NCT01652287|P2|Participant Flow|Control|yogurt cultured with starter YF-L702
130468|NCT01652287|P1|Participant Flow|BB-12|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
130469|NCT01652287|O2|Outcome|Control|yogurt cultured with starter YF-L702
130470|NCT01652287|O1|Outcome|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
130471|NCT01652287|E2|Reported Event|Control|yogurt cultured with starter YF-L702
130472|NCT01652287|E1|Reported Event|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
130473|NCT01652001|B3|Baseline|Total|Total of all reporting groups
130474|NCT01652001|B2|Baseline|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).
Placebo: Oral spray for application into the oral cavity"
130475|NCT01652001|B1|Baseline|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).
Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.
Malic Acid: Oral spray for application into the oral cavity"
130476|NCT01652001|P2|Participant Flow|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).
Placebo: Oral spray for application into the oral cavity"
130477|NCT01652001|P1|Participant Flow|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).
Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.
Malic Acid: Oral spray for application into the oral cavity"
130478|NCT01652001|O2|Outcome|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).
Placebo: Oral spray for application into the oral cavity"
130479|NCT01652001|O1|Outcome|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).
Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.
Malic Acid: Oral spray for application into the oral cavity"
130480|NCT01652001|O2|Outcome|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).
Placebo: Oral spray for application into the oral cavity"
130527|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
130481|NCT01652001|O1|Outcome|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).
Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.
Malic Acid: Oral spray for application into the oral cavity"
130482|NCT01652001|E2|Reported Event|Control|Patients treated with a placebo
130483|NCT01652001|E1|Reported Event|Malic Acid 1%|Patients treated with Malic Acid 1%
130484|NCT01651949|B4|Baseline|Total|Total of all reporting groups
130485|NCT01651949|B3|Baseline|Men Who Have Sex With Men (MSM)|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130486|NCT01651949|B2|Baseline|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130487|NCT01651949|B1|Baseline|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130488|NCT01651949|P3|Participant Flow|Men Who Have Sex With Men (MSM)|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130489|NCT01651949|P2|Participant Flow|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130490|NCT01651949|P1|Participant Flow|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130491|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130492|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130493|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130494|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130495|NCT01651949|O3|Outcome|Men Who Have Sex With Men|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130496|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130497|NCT01651949|O1|Outcome|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130498|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130499|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130500|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130501|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130502|NCT01651949|O3|Outcome|Men Who Have Sex With Men|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130503|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130504|NCT01651949|O1|Outcome|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130505|NCT01651949|E2|Reported Event|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130506|NCT01651949|E1|Reported Event|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
130507|NCT01651936|B3|Baseline|Total|Total of all reporting groups
130508|NCT01651936|B2|Baseline|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
130509|NCT01651936|B1|Baseline|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
130510|NCT01651936|P3|Participant Flow|Extension Study: MK-8457|MK-8457 100 mg BID + MTX for up to 76 weeks in the Extension Study. Participants who completed or had early escape from the Base Study were eligible to enroll in the Extension Study.
130511|NCT01651936|P2|Participant Flow|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
130512|NCT01651936|P1|Participant Flow|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
130513|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
130514|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
130515|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
130516|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
130517|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
130518|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
130519|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
130520|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
130522|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
130523|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
130524|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
130525|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
130526|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
130528|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
130529|NCT01651936|E3|Reported Event|Extension Study: MK-8457|MK-8457 100 mg BID + MTX for up to 76 weeks in the Extension Study. Participants who completed or had early escape from the Base Study were eligible to enroll in the Extension Study
130530|NCT01651936|E2|Reported Event|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
130531|NCT01651936|E1|Reported Event|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
130532|NCT01651780|B3|Baseline|Total|Total of all reporting groups
130533|NCT01651780|B2|Baseline|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130534|NCT01651780|B1|Baseline|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130535|NCT01651780|P2|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130536|NCT01651780|P1|Participant Flow|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during transcatheter aortic valve replacement (TAVR). It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130537|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130538|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130539|NCT01651780|O4|Outcome|UFH: Second Half of Study Site's Enrolled Participants|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the second half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
130540|NCT01651780|O3|Outcome|UFH: First Half of Study Site's Enrolled Participants|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the first half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
130541|NCT01651780|O2|Outcome|Bivalirudin: Second Half of Study Site's Enrolled Participants|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the second half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
130542|NCT01651780|O1|Outcome|Bivalirudin: First Half of Study Site's Enrolled Participants|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the first half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
130543|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130544|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130545|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130648|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
130546|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130565|NCT01651351|B3|Baseline|Total|Total of all reporting groups
130722|NCT01650246|E1|Reported Event|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
130547|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130548|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130549|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130550|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130551|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130552|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130553|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130554|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130555|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130556|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130557|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130558|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130559|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130560|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130561|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130562|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130563|NCT01651780|E2|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130649|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
130868|NCT01649232|P2|Participant Flow|Controls|Healthy people that not receive tDCS
130564|NCT01651780|E1|Reported Event|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
130566|NCT01651351|B2|Baseline|Cohort 2|"Day 1:
GLASSIA at 0.2 mL/kg/min
Placebo at 0.04 mL/kg/min
Day 15:
GLASSIA at 0.04 mL/kg/min
Placebo at 0.2 mL/kg/min
Placebo: Human albumin 2.5%: Intravenous administration"
130567|NCT01651351|B1|Baseline|Cohort 1|"Day 1:
GLASSIA at 0.04 mL/kg/min
Placebo at 0.2 mL/kg/min
Day 15:
GLASSIA at 0.2 mL/kg/min
Placebo at 0.04 mL/kg/min
Placebo: Human albumin 2.5%: Intravenous administration"
130568|NCT01651351|P2|Participant Flow|Cohort 2|"Day 1:
GLASSIA at 0.2 mL/kg/min
Placebo at 0.04 mL/kg/min
Day 15:
GLASSIA at 0.04 mL/kg/min
Placebo at 0.2 mL/kg/min
Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.
Placebo: Human albumin 2.5%: Intravenous administration"
130569|NCT01651351|P1|Participant Flow|Cohort 1|"Day 1:
GLASSIA at 0.04 mL/kg/min
Placebo at 0.2 mL/kg/min
Day 15:
GLASSIA at 0.2 mL/kg/min
Placebo at 0.04 mL/kg/min
Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.
Placebo: Human albumin 2.5%: Intravenous administration"
130570|NCT01651351|O1|Outcome|All Study Participants|
130571|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
130572|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
130573|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
130574|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
130575|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
130576|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
130577|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
130578|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
130579|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
130580|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
130581|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
130582|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
130583|NCT01651351|E2|Reported Event|GLASSIA Infusion Rate- 0.2 mL/kg/Min|"Participants who received simultaneous infusions of:
GLASSIA at 0.2 mL/kg/min
Placebo at 0.04 mL/kg/min"
130584|NCT01651351|E1|Reported Event|GLASSIA Infusion Rate- 0.04 mL/kg/Min|"Participants who received simultaneous infusions of:
GLASSIA at 0.04 mL/kg/min
Placebo at 0.2 mL/kg/min"
130585|NCT01651260|B1|Baseline|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
130586|NCT01651260|P1|Participant Flow|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
130587|NCT01651260|O1|Outcome|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
130588|NCT01651260|O1|Outcome|Hollister Endotracheal (ET) Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
130589|NCT01651260|E1|Reported Event|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
130590|NCT01651208|B3|Baseline|Total|Total of all reporting groups
130591|NCT01651208|B2|Baseline|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
130592|NCT01651208|B1|Baseline|Motivational Interviewing (MINT)|The MINT intervention will consist of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Contentedness, Self-Efficacy theory, and the Stages of Change model.
130593|NCT01651208|P2|Participant Flow|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
130594|NCT01651208|P1|Participant Flow|Motivational Interviewing (MINT)|The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
130595|NCT01651208|O2|Outcome|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
130650|NCT01650779|E1|Reported Event|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion every 2 weeks up to Month 6.
130616|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130723|NCT01649856|B3|Baseline|Total|Total of all reporting groups
130930|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
130596|NCT01651208|O1|Outcome|Motivational Interviewing (MINT)|"The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters.MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
Motivational Interviewing (MINT): Each telephone encounter will have a patient centered approach having the following basic structure"
130597|NCT01651208|O2|Outcome|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
130598|NCT01651208|O1|Outcome|Motivational Interviewing (MINT)|The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
130599|NCT01651208|E2|Reported Event|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
130600|NCT01651208|E1|Reported Event|Motivational Interviewing (MINT)|"The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters.MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
Motivational Interviewing (MINT): Each telephone encounter will have a patient centered approach having the following basic structure"
130601|NCT01651104|B1|Baseline|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
130602|NCT01651104|P1|Participant Flow|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
130603|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
130604|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
130605|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
130606|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
130607|NCT01651104|E1|Reported Event|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
130608|NCT01651000|B3|Baseline|Total|Total of all reporting groups
130609|NCT01651000|B2|Baseline|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130610|NCT01651000|B1|Baseline|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130611|NCT01651000|P2|Participant Flow|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130612|NCT01651000|P1|Participant Flow|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130613|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130614|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130615|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130651|NCT01650519|B3|Baseline|Total|Total of all reporting groups
130867|NCT01649232|B1|Baseline|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
130617|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130618|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130619|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130620|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130621|NCT01651000|E2|Reported Event|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130622|NCT01651000|E1|Reported Event|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
130623|NCT01650831|B1|Baseline|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions
Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
130624|NCT01650831|P1|Participant Flow|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions
Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
130625|NCT01650831|O2|Outcome|Negative Modified BreathID|The amount of subjects that produced negative results for H.pylori with modified BreathID.
130626|NCT01650831|O1|Outcome|Positive Modified BreathID|The amount of subjects that produced positive results for H.pylori with modified BreathID.
130627|NCT01650831|O2|Outcome|Marketed BreathID Negative|Cleared BreathID subjects that were found to be negative for H.pylori
130628|NCT01650831|O1|Outcome|Marketed BreathID Positive|Cleared BreathID subjects that were found to be positive for H.pylori
130629|NCT01650831|O1|Outcome|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions
Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
130630|NCT01650831|E1|Reported Event|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions
Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
130631|NCT01650805|B3|Baseline|Total|Total of all reporting groups
130632|NCT01650805|B2|Baseline|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
130633|NCT01650805|B1|Baseline|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
130634|NCT01650805|P2|Participant Flow|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
130635|NCT01650805|P1|Participant Flow|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
130636|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
130637|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
130638|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
130639|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
130640|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
130641|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
130642|NCT01650805|E2|Reported Event|Imatinib 400 mg|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
130643|NCT01650805|E1|Reported Event|Ponatinib 45 mg|ponatinib: 45 mg tablet, taken orally once daily
130644|NCT01650779|B1|Baseline|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
130645|NCT01650779|P1|Participant Flow|Agalsidase Beta|Commercially available agalsidase beta (Fabrazyme ®) 1.0 milligram per kilogram (mg/kg) administered as an intravenous infusion every 2 weeks (q2w) up to Month 6.
130646|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
130647|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
130717|NCT01650285|E1|Reported Event|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.
Cabazitaxel: Dose Level Day 1, 22, 43
5.0 mg/m2
10.0 mg/m2
15.0 mg/m2
20.0 mg/m2"
130652|NCT01650519|B2|Baseline|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.
IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
130653|NCT01650519|B1|Baseline|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.
IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
130654|NCT01650519|P2|Participant Flow|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.
IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
130655|NCT01650519|P1|Participant Flow|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.
IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
130656|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.
IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
130657|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.
IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
130658|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.
IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
130659|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.
IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
130660|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.
IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
130661|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.
IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
130662|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.
IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
130663|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.
IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
130664|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.
IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
130665|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.
IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
130666|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.
IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
130667|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.
IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
130668|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.
IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
130861|NCT01649297|E4|Reported Event|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
145149|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
130669|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.
IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
130670|NCT01650519|E2|Reported Event|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.
IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
130671|NCT01650519|E1|Reported Event|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.
IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
130672|NCT01650350|B1|Baseline|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).
Naltrexone"
130673|NCT01650350|P1|Participant Flow|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).
Naltrexone"
130674|NCT01650350|O1|Outcome|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).
Naltrexone"
130675|NCT01650350|E1|Reported Event|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).
Naltrexone"
130676|NCT01650324|B6|Baseline|Total|Total of all reporting groups
130677|NCT01650324|B5|Baseline|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
130678|NCT01650324|B4|Baseline|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
130679|NCT01650324|B3|Baseline|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
130680|NCT01650324|B2|Baseline|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
130681|NCT01650324|B1|Baseline|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
130682|NCT01650324|P5|Participant Flow|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
130683|NCT01650324|P4|Participant Flow|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
130684|NCT01650324|P3|Participant Flow|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
130685|NCT01650324|P2|Participant Flow|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
130686|NCT01650324|P1|Participant Flow|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
130687|NCT01650324|O5|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
130688|NCT01650324|O4|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
130689|NCT01650324|O3|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
130690|NCT01650324|O2|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
130691|NCT01650324|O1|Outcome|Placebo|Participants received a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg or 600 mg.
130692|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
130693|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
130694|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
130695|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
130696|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
130697|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
130698|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
130699|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
130700|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
130701|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
130702|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
130703|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
130704|NCT01650324|O5|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
130705|NCT01650324|O4|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
130706|NCT01650324|O3|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
130707|NCT01650324|O2|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
130708|NCT01650324|O1|Outcome|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
130709|NCT01650324|E5|Reported Event|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
130710|NCT01650324|E4|Reported Event|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
130711|NCT01650324|E3|Reported Event|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
130712|NCT01650324|E2|Reported Event|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
130713|NCT01650324|E1|Reported Event|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
130714|NCT01650285|B1|Baseline|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.
Cabazitaxel: Dose Level Day 1, 22, 43
5.0 mg/m2
10.0 mg/m2
15.0 mg/m2
20.0 mg/m2"
130715|NCT01650285|P1|Participant Flow|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.
Cabazitaxel: Dose Level Day 1, 22, 43
5.0 mg/m2
10.0 mg/m2
15.0 mg/m2
20.0 mg/m2"
130716|NCT01650285|O1|Outcome|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.
Cabazitaxel: Dose Level Day 1, 22, 43
5.0 mg/m2
10.0 mg/m2
15.0 mg/m2
20.0 mg/m2"
130724|NCT01649856|B2|Baseline|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130725|NCT01649856|B1|Baseline|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130726|NCT01649856|P2|Participant Flow|Rituximab Intravenous (IV)|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130727|NCT01649856|P1|Participant Flow|Rituximab Subcutaneous (SC)|Participants with previously untreated, cluster of differentiation (CD) 20-positive diffuse large B-cell lymphoma (DLBCL) received up to 8 cycles of rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 milligrams per meter-squared (mg/m^2) via IV infusion; subsequent doses were given as 1400 milligrams (mg) via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved complete response (CR) or complete response unconfirmed (CRu) after 4 cycles, but all participants received a full 8 cycles of rituximab.
130728|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130729|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130730|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130731|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130732|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130862|NCT01649297|E3|Reported Event|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
130863|NCT01649297|E2|Reported Event|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
130733|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130931|NCT01648790|O5|Outcome|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
130734|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130735|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130736|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130737|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130738|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130739|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130740|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130741|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130742|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130743|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130744|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
136584|NCT01627002|E5|Reported Event|Part A PA401 10 mg|
130745|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130746|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130747|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130748|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130749|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130750|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130751|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130752|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130753|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130754|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
145150|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
130776|NCT01649791|E1|Reported Event|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study"
130777|NCT01649557|B4|Baseline|Total|Total of all reporting groups
136585|NCT01627002|E4|Reported Event|Part A PA401 3.0 mg|
130755|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130756|NCT01649856|E2|Reported Event|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130757|NCT01649856|E1|Reported Event|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
130758|NCT01649804|B1|Baseline|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130759|NCT01649804|P1|Participant Flow|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 milligram/kilogram (mg/kg) intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130760|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130761|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130762|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130763|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130764|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130765|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130766|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130767|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130768|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130769|NCT01649804|E1|Reported Event|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
130770|NCT01649791|B1|Baseline|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study"
130771|NCT01649791|P1|Participant Flow|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study"
130772|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study"
130773|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study"
130774|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study"
130775|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study"
130778|NCT01649557|B3|Baseline|Prior Apripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130779|NCT01649557|B2|Baseline|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130780|NCT01649557|B1|Baseline|Prior Brexiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130781|NCT01649557|P3|Participant Flow|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130782|NCT01649557|P2|Participant Flow|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130783|NCT01649557|P1|Participant Flow|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130784|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130785|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130786|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130787|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130788|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130789|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130790|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130791|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130792|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130793|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130794|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130864|NCT01649297|E1|Reported Event|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
130865|NCT01649232|B3|Baseline|Total|Total of all reporting groups
130795|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130932|NCT01648790|O4|Outcome|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
130796|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130797|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130798|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130799|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130800|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130801|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130802|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130803|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130804|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130805|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130806|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130807|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130808|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130809|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130810|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130811|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130812|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130813|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130814|NCT01649557|E3|Reported Event|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130815|NCT01649557|E2|Reported Event|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130816|NCT01649557|E1|Reported Event|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
130817|NCT01649505|B3|Baseline|Total|Total of all reporting groups
130818|NCT01649505|B2|Baseline|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.
breast reconstruction : Undergo electrocoagulation dissection technique"
130819|NCT01649505|B1|Baseline|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.
breast reconstruction : Undergo sharp dissection technique
fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
130820|NCT01649505|P2|Participant Flow|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.
breast reconstruction : Undergo electrocoagulation dissection technique"
130821|NCT01649505|P1|Participant Flow|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.
breast reconstruction : Undergo sharp dissection technique
fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
130822|NCT01649505|O2|Outcome|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.
breast reconstruction : Undergo electrocoagulation dissection technique"
130823|NCT01649505|O1|Outcome|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.
breast reconstruction : Undergo sharp dissection technique
fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
130824|NCT01649505|E2|Reported Event|Arm II (Standard Electrocoagulation)|Patients undergo standard electrocoagulation dissection technique.
130825|NCT01649505|E1|Reported Event|Arm I (Fibrin Sealant)|Patients undergo sharp dissection technique with fibrin sealant closure.
130826|NCT01649362|B3|Baseline|Total|Total of all reporting groups
130827|NCT01649362|B2|Baseline|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
130828|NCT01649362|B1|Baseline|Control Group|no prefeeding oral stimulation
130829|NCT01649362|P2|Participant Flow|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
130830|NCT01649362|P1|Participant Flow|Control Group|no prefeeding oral stimulation
130831|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
130832|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
130833|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
130834|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
130835|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
130836|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
130837|NCT01649362|E2|Reported Event|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
130838|NCT01649362|E1|Reported Event|Control Group|no prefeeding oral stimulation
130839|NCT01649297|B6|Baseline|Total|Total of all reporting groups
130840|NCT01649297|B5|Baseline|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
130841|NCT01649297|B4|Baseline|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
130842|NCT01649297|B3|Baseline|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
130843|NCT01649297|B2|Baseline|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
130844|NCT01649297|B1|Baseline|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
130845|NCT01649297|P5|Participant Flow|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
130846|NCT01649297|P4|Participant Flow|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
130847|NCT01649297|P3|Participant Flow|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
130848|NCT01649297|P2|Participant Flow|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
130849|NCT01649297|P1|Participant Flow|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
130850|NCT01649297|O5|Outcome|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
130851|NCT01649297|O4|Outcome|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
130852|NCT01649297|O3|Outcome|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
130853|NCT01649297|O2|Outcome|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
130854|NCT01649297|O1|Outcome|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
130855|NCT01649297|O5|Outcome|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
130856|NCT01649297|O4|Outcome|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
130857|NCT01649297|O3|Outcome|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
130858|NCT01649297|O2|Outcome|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
130859|NCT01649297|O1|Outcome|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
130860|NCT01649297|E5|Reported Event|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
130928|NCT01648790|O3|Outcome|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
130929|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
130869|NCT01649232|P1|Participant Flow|Active tDCS|"Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days.
55 % of subjects led the anode in temporal lobe (60% right temporal lobe and 40% in left temporal lobe). 8 % of subjects led de anode in parietal lobe (80 % in left hemisphere), and the rest of subjets 37 % of them led the anodo in frontal and prefrontal lobe (55 % in right frontal lobe and 45 % in left frontal lobe)."
130870|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
130871|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
130872|NCT01649232|O4|Outcome|Control Group at 3 Months|Healthy people that not receive tDCS
130873|NCT01649232|O3|Outcome|Active tDCS at 3 Months|l Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
130874|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
130875|NCT01649232|O1|Outcome|Active tDCS Group|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
130876|NCT01649232|O4|Outcome|Control Group at 3 Months|Healthy people that not receive tDCS
130877|NCT01649232|O3|Outcome|Active tDCS at 3 Months|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
130878|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
130879|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
130880|NCT01649232|O4|Outcome|Controls at 3 Months|Healthy people that not receive tDCS
130881|NCT01649232|O3|Outcome|Active tDCS at 3 Months|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
130882|NCT01649232|O2|Outcome|Controls|Healthy people that not receive tDCS
130883|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
130884|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
130885|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
130886|NCT01649232|E2|Reported Event|Controls|Healthy people that not receive tDCS
130887|NCT01649232|E1|Reported Event|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
130888|NCT01649180|B1|Baseline|Axitinib|"Axitinib will be given orally and will continue until progression of disease.
Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
130889|NCT01649180|P1|Participant Flow|Axitinib|"Axitinib will be given orally and will continue until progression of disease.
Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
130890|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.
Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
130891|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.
Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
130892|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.
Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
130893|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.
Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
130894|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.
Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
130895|NCT01649180|E1|Reported Event|Axitinib|"Axitinib will be given orally and will continue until progression of disease.
Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
130896|NCT01648920|B1|Baseline|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130897|NCT01648920|P1|Participant Flow|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130898|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130924|NCT01648790|P2|Participant Flow|Sequence 2|Day 1= 2 mg test ODT2, T-Fast; Day 2= 5 mg ODT1, T-Fast; Day 3= 5 mg test ODT2, T-Fast; Day 4= 5 mg test ODT2, W-Fast; Day 5= 5 mg test ODT2, T-Fed
130926|NCT01648790|O5|Outcome|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
130927|NCT01648790|O4|Outcome|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
130899|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130900|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130901|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130902|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130903|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130904|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130905|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130906|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130907|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130908|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130909|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130925|NCT01648790|P1|Participant Flow|Sequence 1|Day 1= 5 milligrams (mg) prasugrel without Magnasweet (reference) orally disintegrating tablet (ODT1), given on top of tongue in fasted state (T-Fast); Day 2= 5 mg prasugrel with Magnasweet (test) orally disintegrating tablet (ODT2),T-Fast; Day 3= 5 mg test ODT2, given dispersed in water in fasted state (W-Fast); Day 4= 5 mg test ODT2, given on top of tongue in fed state (T-Fed); Day 5= 2 mg test ODT2, T-Fast
130910|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130911|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130912|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130913|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130914|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130915|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130916|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130917|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130918|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130919|NCT01648920|E1|Reported Event|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests
NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
130920|NCT01648790|B1|Baseline|All Participants|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® formulation (ODT1) or orally disintegrating tablet containing Magnasweet® formulation (ODT2) given either on top of tongue or dispersed in water administered in either the fasted or fed state. 2 mg prasugrel ODT2 given on top of tongue in the fasted state.
130921|NCT01648790|P5|Participant Flow|Sequence 5|Day 1= 5 mg test ODT2, T-Fast; Day 2= 5 mg test ODT2, W-Fast; Day 3= 5 mg test ODT2, T-Fed; Day 4= 2 mg test ODT2, T-Fast; Day 5= 5 mg ODT1, T-Fast
130922|NCT01648790|P4|Participant Flow|Sequence 4|Day 1= 5 mg test ODT2, W-Fast; Day 2= 5 mg test ODT2, T-Fed; Day 3= 2 mg test ODT2, T-Fast; Day 4= 5 mg ODT1,T-Fast; Day 5= 5 mg test ODT2, T-Fast
130923|NCT01648790|P3|Participant Flow|Sequence 3|Day 1= 5 mg test ODT2, T-Fed; Day 2= 2 mg test ODT2, T-Fast; Day 3= 5 mg ODT1, T-Fast; Day 4= 5 mg test ODT2, T-Fast; Day 5= 5 mg test ODT2, W-Fast
134022|NCT01639833|O2|Outcome|TachoSil®|"Topical Hemostat
TachoSil®: Topical Hemostat"
130933|NCT01648790|O3|Outcome|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
130934|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
130935|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
130936|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
130937|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
130938|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
130939|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
130940|NCT01648790|E5|Reported Event|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
130941|NCT01648790|E4|Reported Event|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
130942|NCT01648790|E3|Reported Event|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
130943|NCT01648790|E2|Reported Event|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
130944|NCT01648790|E1|Reported Event|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
130945|NCT01648699|B1|Baseline|Osmotic Release Oral System (OROS) Hydromorphone|Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
130946|NCT01648699|P1|Participant Flow|Osmotic Release Oral System (OROS) Hydromorphone|Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
130947|NCT01648699|O1|Outcome|OROS Hydromorphone|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
130948|NCT01648699|O8|Outcome|OROS Hydromorphone (No Dose Indicated)|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning for 28 days, as the dose was not indicated for these participants.
130949|NCT01648699|O7|Outcome|OROS Hydromorphone 40 mg|OROS Hydromorphone was administered as 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130950|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130951|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130952|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130953|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130972|NCT01647542|B3|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
145151|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
130954|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130955|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130956|NCT01648699|O7|Outcome|OROS Hydromorphone 40 mg|OROS Hydromorphone was administered as 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130957|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130958|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130959|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130960|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130961|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130962|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130963|NCT01648699|O7|Outcome|OROS Hydromorphone 36 mg|OROS Hydromorphone was administered as 36 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130964|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130965|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130966|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130967|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130968|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130969|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
130970|NCT01648699|E1|Reported Event|OROS Hydromorphone|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
130971|NCT01647542|B4|Baseline|Total|Total of all reporting groups
130973|NCT01647542|B2|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
130974|NCT01647542|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
130975|NCT01647542|P3|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
130976|NCT01647542|P2|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
130977|NCT01647542|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
130978|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
130979|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
130980|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
130981|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
130982|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
130983|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
130984|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
130985|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
130986|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
130987|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
130988|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
130989|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
130990|NCT01647542|E3|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
130991|NCT01647542|E2|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
130992|NCT01647542|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
130993|NCT01648582|B4|Baseline|Total|Total of all reporting groups
130994|NCT01648582|B3|Baseline|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
130995|NCT01648582|B2|Baseline|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
130996|NCT01648582|B1|Baseline|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
130997|NCT01648582|P3|Participant Flow|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
130998|NCT01648582|P2|Participant Flow|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
130999|NCT01648582|P1|Participant Flow|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131000|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131001|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131002|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131003|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131004|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131005|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131006|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131007|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131008|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131009|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131010|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131011|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131012|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131013|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131014|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
134441|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
131015|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131016|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131017|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131473|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
131018|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131019|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131020|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131021|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131022|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131023|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131024|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131025|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131026|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131027|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131028|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131029|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131030|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
131031|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131032|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131033|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131034|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131035|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131036|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
131037|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131038|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131039|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131040|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131041|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131042|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
131043|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131044|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131045|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131046|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131047|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131048|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131049|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
131050|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131051|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131052|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
131053|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131054|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131055|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
131056|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131057|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131058|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and/or a sulfonylurea.
131059|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131060|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131061|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and/or a sulfonylurea.
131062|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131063|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131064|NCT01648582|E3|Reported Event|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
131065|NCT01648582|E2|Reported Event|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131066|NCT01648582|E1|Reported Event|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
131067|NCT01648530|B1|Baseline|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
131068|NCT01648530|P1|Participant Flow|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
131069|NCT01648530|O2|Outcome|Participants With Chronic Migraine|Participants who returned completed internet survey with Chronic Migraine defined as ≥15 headache days/month. No intervention was administered in this study.
131070|NCT01648530|O1|Outcome|Participants With Episodic Migraine|Participants who returned completed internet survey with Episodic Migraine defined as <15 headache days/month. No intervention was administered in this study.
131071|NCT01648530|O1|Outcome|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
131072|NCT01648530|E1|Reported Event|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
131073|NCT01648491|B1|Baseline|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells
Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.
Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
131074|NCT01648491|P1|Participant Flow|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells
Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.
Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
131075|NCT01648491|O1|Outcome|Stem Cell Treatment|Muscle biopsy and injection of autologous stem cells. Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the urethra.
131076|NCT01648491|O1|Outcome|Stem Cell Treatment|Muscle biopsy and injection of autologous stem cells. Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the urethra.
131077|NCT01648491|O1|Outcome|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells
Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.
Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
131078|NCT01648491|O1|Outcome|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells
Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.
Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
131367|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
145152|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
131079|NCT01648491|E1|Reported Event|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells
Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.
Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
131080|NCT01648452|B1|Baseline|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131842|NCT01645735|E1|Reported Event|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
131081|NCT01648452|P1|Participant Flow|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131082|NCT01648452|O1|Outcome|Untreated Control Eye|
131083|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131084|NCT01648452|O1|Outcome|Untreated Control Eye|
131085|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131086|NCT01648452|O1|Outcome|Untreated Control Eye|
131087|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131088|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131089|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131090|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131091|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131092|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131093|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131094|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131095|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
131096|NCT01648452|E2|Reported Event|NT-501 CNTF-releasing Implant Events > 6 Months Post-implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline. The events listed are adverse events reported after the primary outcome endpoint of 6 months post-implantation.
131097|NCT01648452|E1|Reported Event|NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline. The events listed reflect the primary outcome endpoint of adverse events reported within 6 months post-implantation.
131098|NCT01648140|B5|Baseline|Total|Total of all reporting groups
131099|NCT01648140|B4|Baseline|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131100|NCT01648140|B3|Baseline|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131101|NCT01648140|B2|Baseline|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131102|NCT01648140|B1|Baseline|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131103|NCT01648140|P4|Participant Flow|GSK2336805 60 mg, G4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131368|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131369|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
134442|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
131412|NCT01647217|E2|Reported Event|Placepo Pads Contol Arm|"10 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 each) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Placebo: Lid scrub once or twice per day for one month"
131843|NCT01645709|B3|Baseline|Total|Total of all reporting groups
131104|NCT01648140|P3|Participant Flow|Telaprevir, G1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131105|NCT01648140|P2|Participant Flow|GSK2336805 60 mg, G1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131106|NCT01648140|P1|Participant Flow|GSK2336805 40 mg, G1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a [PEG] + Ribavirin [RIBA]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kilogram [kg]) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131107|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131108|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131109|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131110|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131111|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131112|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131113|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131114|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131115|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131370|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131371|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131116|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131117|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131118|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131119|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131120|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131121|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131122|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131123|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131124|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131125|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131126|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131127|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131372|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131373|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131767|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
131128|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131129|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131130|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131131|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131132|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131133|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131134|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131135|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131136|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131137|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131138|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131139|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131374|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131375|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
134443|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
131140|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131141|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131142|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131143|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131144|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131145|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131146|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131147|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131148|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131149|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.
131150|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131151|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131376|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131377|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
134444|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
131152|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131153|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131154|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131155|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131156|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131157|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131158|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131159|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131160|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131161|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131162|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131163|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131378|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131379|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
134445|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
131164|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131165|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131166|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131167|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131168|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131169|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131170|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131171|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131172|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131173|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131174|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131175|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
131380|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131381|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131382|NCT01647711|E6|Reported Event|All Participants|All treated participants included in the study.
131176|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131177|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
131178|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131179|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
131180|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131181|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2divided doses with food.
131182|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken in 2 divided doses with food.
131183|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
131184|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131185|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
131186|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131187|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131188|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131189|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131190|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131191|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131192|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131193|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131194|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131195|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131196|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131197|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131198|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131199|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131200|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131383|NCT01647711|E5|Reported Event|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131384|NCT01647711|E4|Reported Event|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
134446|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
131201|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131202|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131203|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131204|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131205|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131206|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131207|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131208|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131209|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131210|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131211|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131212|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131385|NCT01647711|E3|Reported Event|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131386|NCT01647711|E2|Reported Event|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
134447|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
131213|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131214|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131215|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131216|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131217|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131218|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131219|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131220|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131221|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131222|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131223|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131224|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131387|NCT01647711|E1|Reported Event|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131388|NCT01647464|B1|Baseline|Contrast Administration|Patients undergoing contrast-enhanced echo.
131389|NCT01647464|P1|Participant Flow|Contrast Administration|Patients undergoing contrast-enhanced echo.
145153|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
131225|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131226|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131227|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131228|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131229|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131230|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131231|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131232|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131233|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131234|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131235|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131236|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131390|NCT01647464|O1|Outcome|Contrast Administration|Patients undergoing contrast-enhanced echo.
131391|NCT01647464|E1|Reported Event|Contrast Administration|Patients undergoing contrast-enhanced echo.
131392|NCT01647438|B3|Baseline|Total|Total of all reporting groups
131497|NCT01646398|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
131237|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131238|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131239|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131240|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131241|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131242|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131243|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131244|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131245|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131246|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131247|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131248|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131410|NCT01647217|O2|Outcome|Placepo Pads Contol Arm|"10 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 each) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Placebo: Lid scrub once or twice per day for one month"
131498|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
131249|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131250|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131251|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131252|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131253|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131254|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131255|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131256|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131257|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131258|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131259|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131260|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131411|NCT01647217|O1|Outcome|Terpinen-4-ol Treatment Arm|"10 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (5 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Terpinen-4-ol: Lid scrub once or twice per day for one month."
131499|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
131261|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131262|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131263|NCT01648140|E4|Reported Event|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131264|NCT01648140|E3|Reported Event|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131265|NCT01648140|E2|Reported Event|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
131266|NCT01648140|E1|Reported Event|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
131267|NCT01648101|B4|Baseline|Total|Total of all reporting groups
131268|NCT01648101|B3|Baseline|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131269|NCT01648101|B2|Baseline|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131270|NCT01648101|B1|Baseline|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131271|NCT01648101|P3|Participant Flow|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131272|NCT01648101|P2|Participant Flow|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131273|NCT01648101|P1|Participant Flow|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131274|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131275|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131276|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131277|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131278|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131279|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131280|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131281|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131450|NCT01646814|O2|Outcome|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets
Aspirin tablets: 325 mg aspirin tablets (USP)"
131451|NCT01646814|O1|Outcome|PL2200|"Investigational product, PL2200
PL2200: PL2200, containing 325 mg aspirin active ingredient"
131282|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131283|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131284|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131285|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131286|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131287|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131288|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131289|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131290|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131452|NCT01646814|E2|Reported Event|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets
Aspirin tablets: 325 mg aspirin tablets (USP)"
131453|NCT01646814|E1|Reported Event|PL2200|"Investigational product, PL2200
PL2200: PL2200, containing 325 mg aspirin active ingredient"
131291|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131292|NCT01648101|O4|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131293|NCT01648101|O3|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131294|NCT01648101|O2|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131295|NCT01648101|O1|Outcome|Overall Study Arm|
131296|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131297|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131298|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131299|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131300|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131454|NCT01646671|B4|Baseline|Total|Total of all reporting groups
131768|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
131301|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131302|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131303|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131304|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131305|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131306|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131307|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131308|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131309|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131495|NCT01646398|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
131995|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
131310|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131311|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131312|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131313|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131314|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131315|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131316|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131317|NCT01648101|E3|Reported Event|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131318|NCT01648101|E2|Reported Event|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131996|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
131319|NCT01648101|E1|Reported Event|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
131320|NCT01647945|B5|Baseline|Total|Total of all reporting groups
131321|NCT01647945|B4|Baseline|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
131322|NCT01647945|B3|Baseline|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
131323|NCT01647945|B2|Baseline|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
131324|NCT01647945|B1|Baseline|Placebo|Placebo: placebo pill
131325|NCT01647945|P4|Participant Flow|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
131326|NCT01647945|P3|Participant Flow|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
131327|NCT01647945|P2|Participant Flow|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
131328|NCT01647945|P1|Participant Flow|Placebo|Placebo: placebo pill
131329|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
131330|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
131331|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
131332|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
131333|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
131334|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
131335|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
131336|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
131337|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
131338|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
131339|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
131340|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
131341|NCT01647945|E4|Reported Event|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
131342|NCT01647945|E3|Reported Event|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
131343|NCT01647945|E2|Reported Event|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
131344|NCT01647945|E1|Reported Event|Placebo|Placebo: placebo pill
131345|NCT01647737|B3|Baseline|Total|Total of all reporting groups
131346|NCT01647737|B2|Baseline|Placebo|"Xylitol
Green tea lozenge: 4-6 times daily"
131347|NCT01647737|B1|Baseline|Green Tea Lozenge|"GTP
Green tea lozenge: 4-6 times daily"
131348|NCT01647737|P2|Participant Flow|Placebo|Xylitol lozenge 4 - 6 times daily
131349|NCT01647737|P1|Participant Flow|Green Tea Lozenge|"GTP
Green tea lozenge: 4-6 times daily"
131350|NCT01647737|O2|Outcome|Placebo|Xylitol lozenge 4 - 6 times daily
131351|NCT01647737|O1|Outcome|Green Tea Lozenge|"GTP
Green tea lozenge: 4-6 times daily"
131352|NCT01647737|E2|Reported Event|Xylitol|"4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks
Xylitol: 4-6 times daily"
131353|NCT01647737|E1|Reported Event|MighTeaFlow|"4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks
MighTeaFlow: 4-6 times daily"
131354|NCT01647711|B6|Baseline|Total|Total of all reporting groups
131355|NCT01647711|B5|Baseline|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131356|NCT01647711|B4|Baseline|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131357|NCT01647711|B3|Baseline|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131358|NCT01647711|B2|Baseline|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131359|NCT01647711|B1|Baseline|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131360|NCT01647711|P5|Participant Flow|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131361|NCT01647711|P4|Participant Flow|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131362|NCT01647711|P3|Participant Flow|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131363|NCT01647711|P2|Participant Flow|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131364|NCT01647711|P1|Participant Flow|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131365|NCT01647711|O1|Outcome|Afatinib|Patients receiving oral administration of afatinib film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
131366|NCT01647711|O1|Outcome|Afatinib|Patients receiving oral administration of afatinib film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
134448|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
131393|NCT01647438|B2|Baseline|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
131394|NCT01647438|B1|Baseline|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
131395|NCT01647438|P2|Participant Flow|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
131396|NCT01647438|P1|Participant Flow|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
131397|NCT01647438|O2|Outcome|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
131398|NCT01647438|O1|Outcome|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
131399|NCT01647438|O2|Outcome|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
131400|NCT01647438|O1|Outcome|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
131401|NCT01647438|E2|Reported Event|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
131402|NCT01647438|E1|Reported Event|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
131403|NCT01647217|B3|Baseline|Total|Total of all reporting groups
131404|NCT01647217|B2|Baseline|Placepo Pads Contol Arm|"9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Placebo: Lid scrub once or twice per day for one month"
131405|NCT01647217|B1|Baseline|Terpinen-4-ol Treatment Arm|"8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Terpinen-4-ol: Lid scrub once or twice per day for one month."
131406|NCT01647217|P2|Participant Flow|Placepo Pads Contol Arm|"9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Placebo: Lid scrub once or twice per day for one month"
131407|NCT01647217|P1|Participant Flow|Terpinen-4-ol Treatment Arm|"8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Terpinen-4-ol: Lid scrub once or twice per day for one month."
131408|NCT01647217|O2|Outcome|Placepo Pads Contol Arm|"9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Placebo: Lid scrub once or twice per day for one month"
131409|NCT01647217|O1|Outcome|Terpinen-4-ol Treatment Arm|"8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Terpinen-4-ol: Lid scrub once or twice per day for one month."
131496|NCT01646398|P2|Participant Flow|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
131413|NCT01647217|E1|Reported Event|Terpinen-4-ol Treatment Arm|"10 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (5 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Terpinen-4-ol: Lid scrub once or twice per day for one month."
131414|NCT01646827|B3|Baseline|Total|Total of all reporting groups
131415|NCT01646827|B2|Baseline|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131416|NCT01646827|B1|Baseline|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131417|NCT01646827|P2|Participant Flow|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131418|NCT01646827|P1|Participant Flow|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131419|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131420|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131421|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131422|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131423|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131424|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131425|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131426|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131427|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131428|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131429|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131430|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131431|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131432|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131433|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131434|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131435|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131436|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131437|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131438|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131439|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131440|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131441|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131442|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131443|NCT01646827|E2|Reported Event|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single aripiprazole IM depot (400 mg) injection in the gluteal muscle.
131444|NCT01646827|E1|Reported Event|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single aripiprazole IM depot (400 mg) injection in the deltoid muscle.
131445|NCT01646814|B3|Baseline|Total|Total of all reporting groups
131446|NCT01646814|B2|Baseline|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets
Aspirin tablets: 325 mg aspirin tablets (USP)"
131447|NCT01646814|B1|Baseline|PL2200|"Investigational product, PL2200
PL2200: PL2200, containing 325 mg aspirin active ingredient"
131448|NCT01646814|P2|Participant Flow|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets
Aspirin tablets: 325 mg aspirin tablets (USP)"
131449|NCT01646814|P1|Participant Flow|PL2200|"Investigational product, PL2200
PL2200: PL2200, containing 325 mg aspirin active ingredient"
131472|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
131455|NCT01646671|B3|Baseline|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
131456|NCT01646671|B2|Baseline|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
131457|NCT01646671|B1|Baseline|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
131458|NCT01646671|P3|Participant Flow|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
131459|NCT01646671|P2|Participant Flow|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
131460|NCT01646671|P1|Participant Flow|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
131461|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
131462|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
131463|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
131464|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
131465|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
131466|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
131467|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
131468|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
131469|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
131470|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
131471|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
131500|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
131474|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
131475|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
131476|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
131477|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
131478|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
131479|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
131480|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
131481|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
131482|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
131483|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
131484|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
131485|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
131486|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
131487|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
131488|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
131489|NCT01646671|E4|Reported Event|Total Participants|All participants who were treated
131490|NCT01646671|E3|Reported Event|LCZ 400 mg + Other HTN Medications|LCZ 400 mg + other HTN medications
131491|NCT01646671|E2|Reported Event|LCZ 400 mg|LCZ 400 mg
131492|NCT01646671|E1|Reported Event|LCZ 200 mg|LCZ 200 mg
131493|NCT01646398|B3|Baseline|Total|Total of all reporting groups
131494|NCT01646398|B2|Baseline|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
131997|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
131501|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
131502|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
132001|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
131503|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
131504|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
131505|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
131506|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
131507|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
131508|NCT01646398|E2|Reported Event|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
131509|NCT01646398|E1|Reported Event|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
131510|NCT01646385|B3|Baseline|Total|Total of all reporting groups
131511|NCT01646385|B2|Baseline|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131512|NCT01646385|B1|Baseline|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131513|NCT01646385|P2|Participant Flow|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131514|NCT01646385|P1|Participant Flow|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131515|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131516|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131517|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131518|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131519|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131520|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131521|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131766|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131522|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131523|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131524|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131525|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131526|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131527|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131528|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131529|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131530|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131531|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131532|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131533|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131534|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131535|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131727|NCT01646125|B2|Baseline|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
131536|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131537|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131538|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131539|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131540|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131541|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131542|NCT01646385|E2|Reported Event|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
131543|NCT01646385|E1|Reported Event|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
131544|NCT01646320|B3|Baseline|Total|Total of all reporting groups
131545|NCT01646320|B2|Baseline|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131546|NCT01646320|B1|Baseline|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131547|NCT01646320|P2|Participant Flow|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131548|NCT01646320|P1|Participant Flow|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131549|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131550|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131551|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131552|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131553|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131554|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131555|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131556|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131557|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131558|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131559|NCT01646320|E2|Reported Event|PLA + SAXA + MET|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131560|NCT01646320|E1|Reported Event|DAPA + SAXA + MET|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
131561|NCT01646268|B3|Baseline|Total|Total of all reporting groups
131562|NCT01646268|B2|Baseline|Placebo|"Placebo, daily doses, placebo group
Placebo Patch: Transdermal Patch
Size:
10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
Subjects randomized to placebo will receive matching placebo patches."
131589|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131563|NCT01646268|B1|Baseline|Rotigotine|"Rotigotine, daily doses, treatment group
Rotigotine: Transdermal Patch
Content:
2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
131564|NCT01646268|P2|Participant Flow|Placebo|"Placebo, daily doses, placebo group
Placebo Patch: Transdermal Patch
Size:
10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
Subjects randomized to placebo will receive matching placebo patches."
131565|NCT01646268|P1|Participant Flow|Rotigotine|"Rotigotine, daily doses, treatment group
Rotigotine: Transdermal Patch
Content:
2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
131566|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group
Placebo Patch: Transdermal Patch
Size:
10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
Subjects randomized to placebo will receive matching placebo patches."
131567|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group
Rotigotine: Transdermal Patch
Content:
2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
131568|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group
Placebo Patch: Transdermal Patch
Size:
10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
Subjects randomized to placebo will receive matching placebo patches."
131569|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group
Rotigotine: Transdermal Patch
Content:
2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
131570|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group
Placebo Patch: Transdermal Patch
Size:
10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
Subjects randomized to placebo will receive matching placebo patches."
131571|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group
Rotigotine: Transdermal Patch
Content:
2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
131572|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group
Placebo Patch: Transdermal Patch
Size:
10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
Subjects randomized to placebo will receive matching placebo patches."
131573|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group
Rotigotine: Transdermal Patch
Content:
2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
131574|NCT01646268|E2|Reported Event|Placebo|"Placebo, daily doses, placebo group
Placebo Patch: Transdermal Patch
Size:
10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
Subjects randomized to placebo will receive matching placebo patches."
131575|NCT01646268|E1|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment group
Rotigotine: Transdermal Patch
Content:
2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
131576|NCT01646255|B3|Baseline|Total Title|
131577|NCT01646255|B2|Baseline|Rotigotine|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
131578|NCT01646255|B1|Baseline|Placebo|Subjects randomized to placebo received matching placebo patches.
131579|NCT01646255|P2|Participant Flow|Rotigotine|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
131580|NCT01646255|P1|Participant Flow|Placebo|Subjects randomized to placebo received matching placebo patches.
131581|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131582|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131583|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131584|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131585|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131586|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131587|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131588|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131728|NCT01646125|B1|Baseline|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131590|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131591|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131592|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131593|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131594|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131595|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131596|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131597|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131598|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131599|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131600|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131601|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131602|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131603|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
131604|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131605|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
131606|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
131607|NCT01646255|E2|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment Group
Subjects will receive rotigotine or placebo patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo is achieved. A combination of patches (rotigotine or matching placebo) will be applied for subjects who require a dose > 8 mg/ 24 h. Each dose level is maintained for 1 week."
131608|NCT01646255|E1|Reported Event|Placebo|"Placebo, daily doses, placebo Group
Subjects randomized to placebo will receive matching placebo patches."
131609|NCT01646177|B5|Baseline|Total|Total of all reporting groups
131610|NCT01646177|B4|Baseline|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131611|NCT01646177|B3|Baseline|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8).
Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131612|NCT01646177|B2|Baseline|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131613|NCT01646177|B1|Baseline|Placebo|Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
131614|NCT01646177|P4|Participant Flow|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131615|NCT01646177|P3|Participant Flow|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10.
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131616|NCT01646177|P2|Participant Flow|50 mg Etanercept|Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
131617|NCT01646177|P1|Participant Flow|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131618|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131619|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131620|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131621|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131622|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131623|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131624|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131625|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131626|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131627|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131628|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131629|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131630|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131631|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131632|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131633|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131634|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131635|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131636|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131637|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131638|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131639|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131640|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131641|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131642|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131643|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131644|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131645|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131646|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131647|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131648|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131649|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131650|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131651|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131652|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131653|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131654|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131655|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131656|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131657|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131658|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131659|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131660|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131661|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131662|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131663|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131664|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131665|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131666|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131667|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131668|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131669|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131670|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131671|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131672|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131673|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131674|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131675|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131676|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131677|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131678|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131679|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131680|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131681|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131682|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131683|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131684|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131685|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131686|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
131687|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
131688|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
131689|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
131690|NCT01646177|E4|Reported Event|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection Q2W until Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).
80 mg ixekizumab: Administered SC"
131691|NCT01646177|E3|Reported Event|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q4W until Week 264.
80 mg ixekizumab: Administered SC"
131692|NCT01646177|E2|Reported Event|50 mg Etanercept|"Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2.
50 mg etanercept: Administered SC"
131693|NCT01646177|E1|Reported Event|Placebo|"Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 (Q2W) until Week 12.
Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).
Placebo: Administered SC"
131694|NCT01646151|B1|Baseline|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
131695|NCT01646151|P1|Participant Flow|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
131696|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
131697|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
131698|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
131699|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
131700|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
131701|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
131702|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
131703|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
131704|NCT01646151|E1|Reported Event|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
131705|NCT01646138|B6|Baseline|Total|Total of all reporting groups
131706|NCT01646138|B5|Baseline|10^7 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^7 TCID50 administered intranasally.
131707|NCT01646138|B4|Baseline|10^6 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^6 TCID50 administered intranasally.
131708|NCT01646138|B3|Baseline|10^5 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^5 TCID50 administered intranasally.
131709|NCT01646138|B2|Baseline|10^4 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^4 TCID50 administered intranasally.
131710|NCT01646138|B1|Baseline|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
131711|NCT01646138|P5|Participant Flow|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
131712|NCT01646138|P4|Participant Flow|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
131713|NCT01646138|P3|Participant Flow|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
131714|NCT01646138|P2|Participant Flow|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
131715|NCT01646138|P1|Participant Flow|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
131716|NCT01646138|O5|Outcome|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
131717|NCT01646138|O4|Outcome|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
131718|NCT01646138|O3|Outcome|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
131719|NCT01646138|O2|Outcome|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
131720|NCT01646138|O1|Outcome|10^3 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^3 TCID 50 administered intranasally.
131721|NCT01646138|E5|Reported Event|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
131722|NCT01646138|E4|Reported Event|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
131723|NCT01646138|E3|Reported Event|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
131724|NCT01646138|E2|Reported Event|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
131725|NCT01646138|E1|Reported Event|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
131726|NCT01646125|B3|Baseline|Total|Total of all reporting groups
131729|NCT01646125|P2|Participant Flow|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
136586|NCT01627002|E3|Reported Event|Part A PA401 1.0 mg|
131730|NCT01646125|P1|Participant Flow|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131731|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
131732|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131733|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
131734|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131735|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
131736|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131737|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
131738|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131739|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
131740|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131741|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
131742|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131743|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
131744|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131745|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
131746|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131747|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
131748|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131749|NCT01646125|E3|Reported Event|Total|Total
131750|NCT01646125|E2|Reported Event|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks."
131751|NCT01646125|E1|Reported Event|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly."
131752|NCT01646073|B3|Baseline|Total|Total of all reporting groups
131753|NCT01646073|B2|Baseline|Adalimumab Eow|Participants were started on adalimumab 40 mg every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
131754|NCT01646073|B1|Baseline|Placebo|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B
131755|NCT01646073|P2|Participant Flow|Adalimumab Eow|Participants were started on 40 mg adalimumab every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
131756|NCT01646073|P1|Participant Flow|Placebo|Participants were started on placebo in Period A and then switched to adalimumab 40 mg eow in Period B
131757|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131758|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131759|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
131760|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
131761|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131762|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131763|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
131764|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
131765|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
145154|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
131769|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131770|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131771|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
131772|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
131773|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131774|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131775|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
131776|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
131777|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131778|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131779|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
131780|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
131781|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131782|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131783|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
131784|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
131785|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131786|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
131787|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
131788|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
131789|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
131790|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
131791|NCT01646073|E3|Reported Event|Any Adalimumab|Participants that received at least one dose of adalimumab during Period A or Period B
131792|NCT01646073|E2|Reported Event|Double-blind Adalimumab Eow|Participants were started on adalimumab eow in Period A (Week 0 to Week 12)
131793|NCT01646073|E1|Reported Event|Double-blind Placebo|Participants were started on placebo in Period A (Week 0 to Week 12)
131794|NCT01646021|B3|Baseline|Total|Total of all reporting groups
131795|NCT01646021|B2|Baseline|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131796|NCT01646021|B1|Baseline|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131797|NCT01646021|P2|Participant Flow|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131798|NCT01646021|P1|Participant Flow|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131799|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131800|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131801|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131802|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131803|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131804|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131805|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131806|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131998|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
131807|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131808|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131809|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131810|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131811|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131812|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131813|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131814|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131815|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131816|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131817|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131818|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131819|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131820|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131821|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131822|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131823|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131824|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131825|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131826|NCT01646021|E2|Reported Event|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
131827|NCT01646021|E1|Reported Event|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
131828|NCT01645735|B3|Baseline|Total|Total of all reporting groups
131829|NCT01645735|B2|Baseline|Ceftriaxone Plus Vancomycin|Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
131830|NCT01645735|B1|Baseline|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
131831|NCT01645735|P2|Participant Flow|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
131832|NCT01645735|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days
131833|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
131834|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
131835|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
131836|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
131837|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2g IV q24 plus vancomycin 15mg/kg IV q12h initially and then dose adjusted based on trough concentrations
131838|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
131839|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
131840|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
131841|NCT01645735|E2|Reported Event|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
131844|NCT01645709|B2|Baseline|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131845|NCT01645709|B1|Baseline|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131846|NCT01645709|P2|Participant Flow|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131847|NCT01645709|P1|Participant Flow|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131848|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131849|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131850|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131851|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131852|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131853|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131854|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131855|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131856|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131857|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131858|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131859|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131860|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131861|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131862|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131863|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131864|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131865|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131866|NCT01645709|E2|Reported Event|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Placebo"
131867|NCT01645709|E1|Reported Event|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Verapamil"
131868|NCT01645280|B6|Baseline|Total|Total of all reporting groups
131869|NCT01645280|B5|Baseline|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131870|NCT01645280|B4|Baseline|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131871|NCT01645280|B3|Baseline|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
131872|NCT01645280|B2|Baseline|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131873|NCT01645280|B1|Baseline|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
131874|NCT01645280|P5|Participant Flow|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131875|NCT01645280|P4|Participant Flow|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131876|NCT01645280|P3|Participant Flow|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
131877|NCT01645280|P2|Participant Flow|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131878|NCT01645280|P1|Participant Flow|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
131879|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131880|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131881|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
132002|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
131882|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131883|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
131884|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131885|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131886|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
131887|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131888|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
131889|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131890|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131891|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
131892|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131893|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
131894|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131895|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131896|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
131897|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131898|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
131899|NCT01645280|E6|Reported Event|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131900|NCT01645280|E5|Reported Event|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131901|NCT01645280|E4|Reported Event|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
131902|NCT01645280|E3|Reported Event|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
131903|NCT01645280|E2|Reported Event|Placebo (Early Escape)|Participants who early escaped at Week 16 and received ustekinumab 90 milligram (mg) subcutaneously at Week 16, 20 and 28 along with methotrexate.
131904|NCT01645280|E1|Reported Event|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
131905|NCT01645176|B1|Baseline|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
131906|NCT01645176|P1|Participant Flow|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
131907|NCT01645176|O1|Outcome|Osteoarthritis of Knee|Change in MRI synovitis
131908|NCT01645176|E1|Reported Event|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
131909|NCT01645111|B1|Baseline|Clevidipine|Clevidipine
131910|NCT01645111|P1|Participant Flow|Clevidipine|Clevidipine
131911|NCT01645111|O1|Outcome|Clevidipine|Clevidipine
131912|NCT01645111|E1|Reported Event|Clevidipine|Clevidipine
131913|NCT01645098|B3|Baseline|Total|Total of all reporting groups
131914|NCT01645098|B2|Baseline|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131915|NCT01645098|B1|Baseline|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
145155|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
132003|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132004|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
131916|NCT01645098|P2|Participant Flow|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131917|NCT01645098|P1|Participant Flow|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131918|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131919|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131920|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131921|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131922|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131923|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131924|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131925|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131926|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131927|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131928|NCT01645098|E2|Reported Event|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131929|NCT01645098|E1|Reported Event|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed
Dexmedetomidine: 0.5 mcg/kg/hr IV"
131930|NCT01645059|B1|Baseline|Disseminated Her 2+ Breast Cancer|
131931|NCT01645059|P1|Participant Flow|Disseminated Her 2+ Breast Cancer|
131932|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
131933|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
131934|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
131935|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
131936|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
131937|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
131938|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
131939|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
131940|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
131941|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
131942|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
131943|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
131944|NCT01645059|O1|Outcome|Disseminated HER 2 + Breast Cancer|
131945|NCT01645059|O1|Outcome|Disseminated Her 2+ Breast Cancer|
131946|NCT01645059|O1|Outcome|Disseminated Her 2+ Breast Cancer|
131947|NCT01645059|E1|Reported Event|Disseminated Her 2+ Breast Cancer|
131948|NCT01644734|B1|Baseline|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
131949|NCT01644734|P1|Participant Flow|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
131950|NCT01644734|O1|Outcome|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
131951|NCT01644734|O1|Outcome|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
131952|NCT01644734|E1|Reported Event|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
131953|NCT01644695|B1|Baseline|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.
Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
131999|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132000|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
145156|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
131954|NCT01644695|P1|Participant Flow|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.
Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
131955|NCT01644695|O1|Outcome|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.
Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
131956|NCT01644695|O1|Outcome|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.
Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
131957|NCT01644695|E1|Reported Event|All Participants|No participant was excempt from this measure.
131958|NCT01644643|B5|Baseline|Total|Total of all reporting groups
131959|NCT01644643|B4|Baseline|cUTI:CAZ-AVI|cUTI: CAZ-AVI
131960|NCT01644643|B3|Baseline|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
131961|NCT01644643|B2|Baseline|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
131962|NCT01644643|B1|Baseline|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
131963|NCT01644643|P4|Participant Flow|cUTI:CAZ-AVI|cUTI: CAZ-AVI
131964|NCT01644643|P3|Participant Flow|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
131965|NCT01644643|P2|Participant Flow|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
131966|NCT01644643|P1|Participant Flow|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
131967|NCT01644643|O6|Outcome|AVI (3)|300-360 mins after dose
131968|NCT01644643|O5|Outcome|CAZ (3)|300-360 mins after dose
131969|NCT01644643|O4|Outcome|AVI (2)|30-90 mins after dose
131970|NCT01644643|O3|Outcome|CAZ (2)|30-90 mins after dose
131971|NCT01644643|O2|Outcome|AVI (1)|15 mins before/after dose
131972|NCT01644643|O1|Outcome|CAZ (1)|15 mins before/after dose
131973|NCT01644643|O6|Outcome|AVI (3)|300-360 mins after dose
131974|NCT01644643|O5|Outcome|CAZ (3)|300-360 mins after dose
131975|NCT01644643|O4|Outcome|AVI (2)|30-90 mins after dose
131976|NCT01644643|O3|Outcome|CAZ (2)|30-90 mins after dose
131977|NCT01644643|O2|Outcome|AVI (1)|15 mins before/after dose
131978|NCT01644643|O1|Outcome|CAZ (1)|15 mins before/after dose
131979|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
131980|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
131981|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
131982|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
131983|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
131984|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
131985|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
131986|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
131987|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
131988|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
131989|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
131990|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
131991|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
131992|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
131993|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
131994|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
145157|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
132005|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132006|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132007|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132008|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132009|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132010|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132011|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132012|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132013|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132014|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132015|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132016|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132017|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132018|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132019|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132020|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132021|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132022|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132023|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132024|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132025|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132026|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132027|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132028|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132029|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132030|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132031|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132032|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132033|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132034|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132035|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132036|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132037|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132038|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132039|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132040|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132041|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132042|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132043|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132044|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132045|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132046|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132047|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132048|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132049|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132050|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132051|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132052|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132053|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132054|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132055|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132056|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
145158|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
132057|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132058|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132059|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132060|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132061|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132062|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132063|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132064|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132065|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132066|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132067|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132068|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132069|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132070|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132071|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132072|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132073|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132074|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132075|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132076|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132077|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132078|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132079|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132080|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132081|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132082|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132083|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132084|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132085|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132086|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132087|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132088|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132089|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132090|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132091|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132092|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132093|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132094|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132095|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132096|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132097|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132098|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132099|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132100|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132101|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132102|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132103|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132104|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132105|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132106|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132107|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132108|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132109|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132110|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132111|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132112|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
145159|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
132113|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132114|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132115|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132116|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132117|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132118|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132119|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
132120|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132121|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132122|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132123|NCT01644643|E4|Reported Event|cUTI:CAZ-AVI|cUTI: CAZ-AVI
132124|NCT01644643|E3|Reported Event|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
132125|NCT01644643|E2|Reported Event|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
132126|NCT01644643|E1|Reported Event|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
132127|NCT01644617|B4|Baseline|Total|Total of all reporting groups
132128|NCT01644617|B3|Baseline|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132129|NCT01644617|B2|Baseline|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132130|NCT01644617|B1|Baseline|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132131|NCT01644617|P3|Participant Flow|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132132|NCT01644617|P2|Participant Flow|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132133|NCT01644617|P1|Participant Flow|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132134|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132135|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132136|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132137|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132138|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132139|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132140|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132141|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132142|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132143|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132144|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132145|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132146|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132147|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132148|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132149|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132150|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132151|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132152|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132153|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
134449|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
132154|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132155|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
134234|NCT01639144|B2|Baseline|Control|Group not receiving autogenous PRP and PPP.
132156|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132157|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132158|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132159|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132160|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132161|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132162|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132163|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132164|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132165|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132166|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132167|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132168|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132169|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132170|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132171|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132172|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132173|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132174|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132175|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132176|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132177|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132178|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132179|NCT01644617|E3|Reported Event|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132180|NCT01644617|E2|Reported Event|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
132181|NCT01644617|E1|Reported Event|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
132182|NCT01643525|B1|Baseline|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System
Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
132183|NCT01643525|P1|Participant Flow|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System
Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
132184|NCT01643525|O1|Outcome|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System
Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
132185|NCT01643525|E1|Reported Event|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System
Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
132186|NCT01644500|B4|Baseline|Total|Total of all reporting groups
132187|NCT01644500|B3|Baseline|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132188|NCT01644500|B2|Baseline|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
134450|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
132189|NCT01644500|B1|Baseline|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132293|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132190|NCT01644500|P3|Participant Flow|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132191|NCT01644500|P2|Participant Flow|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132192|NCT01644500|P1|Participant Flow|1.5 mg Dulaglutide|1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132193|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132194|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132195|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132196|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132197|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132198|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132199|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132200|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132201|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132202|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132203|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132204|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132205|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132206|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132207|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132208|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132209|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132210|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132211|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132212|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132213|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132214|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132215|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132216|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132217|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132218|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132219|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132220|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132221|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132222|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132223|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132224|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132225|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132226|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132227|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132228|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132229|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132230|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132231|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132232|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132233|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132234|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132235|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132236|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132237|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132238|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132239|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132240|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132241|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132242|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132243|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132244|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132245|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132246|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132247|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132248|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132249|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132250|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132251|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132252|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132253|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132254|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132255|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132256|NCT01644500|E3|Reported Event|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
132257|NCT01644500|E2|Reported Event|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132258|NCT01644500|E1|Reported Event|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
132259|NCT01644474|B3|Baseline|Total|Total of all reporting groups
132260|NCT01644474|B2|Baseline|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132261|NCT01644474|B1|Baseline|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132262|NCT01644474|P2|Participant Flow|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132263|NCT01644474|P1|Participant Flow|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous (SC) placebo injection for alirocumab every 2 weeks (Q2W) for 24 weeks.
132264|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132265|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132266|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132267|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132268|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132269|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132270|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132271|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132272|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132273|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132274|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132275|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132276|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132277|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132278|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132279|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132280|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132281|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132282|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132283|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132284|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132285|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132286|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132287|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132288|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132289|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132290|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132291|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132292|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132294|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132295|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132296|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132297|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132298|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132299|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
132300|NCT01644474|E2|Reported Event|Alirocumab 75/Up150 mg Q2W|Participants exposed to Alirocumab 75 mg/Up to 150 mg Q2W (mean exposure of 22 weeks).
132301|NCT01644474|E1|Reported Event|Ezetimibe 10 mg|Participants exposed to Ezetimibe 10 mg (mean exposure of 22 weeks).
132302|NCT01644396|B1|Baseline|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132303|NCT01644396|P1|Participant Flow|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132304|NCT01644396|O1|Outcome|Adalimumab|Number of participants with adverse events
132305|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132306|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132307|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132308|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132309|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132310|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132311|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132312|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132313|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132314|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132315|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132316|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132317|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132318|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132319|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132320|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132321|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132322|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132323|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132324|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
134451|NCT01637935|E2|Reported Event|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
132325|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132513|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132326|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132327|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132328|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132329|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132330|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132331|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132332|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132333|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132334|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132335|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132336|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132337|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132338|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132339|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132340|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132341|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132342|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132343|NCT01644396|E1|Reported Event|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
132344|NCT01644331|B3|Baseline|Total|Total of all reporting groups
132345|NCT01644331|B2|Baseline|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132346|NCT01644331|B1|Baseline|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132347|NCT01644331|P2|Participant Flow|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132348|NCT01644331|P1|Participant Flow|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132349|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132350|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132351|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132352|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132353|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132942|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132512|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132354|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132355|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132356|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132357|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132358|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132359|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132360|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132361|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132362|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132363|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132364|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132365|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132366|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132367|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132368|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132369|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132370|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132371|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132372|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132373|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132374|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132375|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132376|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132377|NCT01644331|E2|Reported Event|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)
Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
132378|NCT01644331|E1|Reported Event|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)
Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
132508|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132379|NCT01644292|B1|Baseline|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
132380|NCT01644292|P1|Participant Flow|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
132381|NCT01644292|O1|Outcome|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
132382|NCT01644292|E1|Reported Event|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
132383|NCT01644240|B4|Baseline|Total|Total of all reporting groups
132384|NCT01644240|B3|Baseline|TD-8954 Dose 2|TD-8954: Intravenous infusion
132385|NCT01644240|B2|Baseline|Placebo|Placebo - saline: Intravenous infusion
132386|NCT01644240|B1|Baseline|TD-8954 Dose 1|TD-8954: Intravenous infusion
132387|NCT01644240|P3|Participant Flow|TD-8954 Dose 2|TD-8954: Intravenous infusion
132388|NCT01644240|P2|Participant Flow|Placebo|Placebo - saline: Intravenous infusion
132389|NCT01644240|P1|Participant Flow|TD-8954 Dose 1|TD-8954: Intravenous infusion
132390|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132391|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132392|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132393|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132394|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132395|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132396|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132397|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132398|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132399|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132400|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132401|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132402|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132403|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132404|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132405|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132406|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132407|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132408|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132409|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132410|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132411|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132412|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132413|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132414|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132415|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132416|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132417|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132418|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132419|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132420|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132421|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132422|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132423|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132424|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132425|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132426|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132427|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132428|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132429|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132430|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132431|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132432|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132433|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132434|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132435|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132436|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132437|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132438|NCT01644240|O3|Outcome|TD-8954 Dose 2|TD-8954: Intravenous infusion
132439|NCT01644240|O2|Outcome|Placebo|Placebo - saline: Intravenous infusion
132440|NCT01644240|O1|Outcome|TD-8954 Dose 1|TD-8954: Intravenous infusion
132441|NCT01644240|E3|Reported Event|TD-8954 Dose 2|TD-8954: Intravenous infusion
132442|NCT01644240|E2|Reported Event|Placebo|Placebo - saline: Intravenous infusion
132443|NCT01644240|E1|Reported Event|TD-8954 Dose 1|TD-8954: Intravenous infusion
132444|NCT01644188|B3|Baseline|Total|Total of all reporting groups
132445|NCT01644188|B2|Baseline|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132509|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132446|NCT01644188|B1|Baseline|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132447|NCT01644188|P2|Participant Flow|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132448|NCT01644188|P1|Participant Flow|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid­ Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low density lipoprotein cholesterol (LDL-C) level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132449|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132450|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132451|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132452|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132453|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132454|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132455|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132456|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132457|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132458|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132459|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132460|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132461|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132462|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132463|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132464|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132465|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132466|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132467|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132468|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132469|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132470|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132471|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132472|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132473|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132474|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132475|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132510|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132476|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132477|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132478|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132479|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132480|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132481|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132482|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132483|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132484|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132485|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132486|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132487|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132488|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132489|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132490|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132491|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132492|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132493|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132494|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132495|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132496|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132497|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132498|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132499|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
132500|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
132501|NCT01644188|E2|Reported Event|Ezetimibe 10 mg|Participants exposed to Ezetimibe 10 mg added to stable LMT (mean exposition of 90 weeks).
132502|NCT01644188|E1|Reported Event|Alirocumab 75/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 /up to 150 mg Q2W added to stable LMT (mean exposition of 90 weeks).
132503|NCT01644175|B3|Baseline|Total|Total of all reporting groups
132504|NCT01644175|B2|Baseline|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132505|NCT01644175|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132506|NCT01644175|P2|Participant Flow|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132507|NCT01644175|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks.
132511|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132514|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132515|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132516|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132517|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132518|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132519|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132520|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132521|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132522|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132523|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132524|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132525|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132526|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132527|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132528|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132529|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132530|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132531|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132532|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132533|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132534|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132535|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132536|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132537|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132538|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132539|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132540|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132541|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132542|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132543|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132544|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132545|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132546|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132547|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132548|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132549|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132550|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132551|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132552|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
132553|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
132554|NCT01644175|E2|Reported Event|Alirocumab 75 /up to 150 mg Q2W|Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 46 weeks).
132555|NCT01644175|E1|Reported Event|Placebo Q2W|Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 45 weeks).
132556|NCT01644058|B1|Baseline|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
132557|NCT01644058|P1|Participant Flow|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
132558|NCT01644058|O1|Outcome|Immediate Loading|"Immediate loading of 2 endo-osseous mandibular implants
Immediate loading"
132559|NCT01644058|O1|Outcome|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
132560|NCT01644058|E1|Reported Event|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
132561|NCT01643928|B6|Baseline|Total|Total of all reporting groups
132562|NCT01643928|B5|Baseline|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132563|NCT01643928|B4|Baseline|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132564|NCT01643928|B3|Baseline|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132565|NCT01643928|B2|Baseline|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132566|NCT01643928|B1|Baseline|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132567|NCT01643928|P5|Participant Flow|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132568|NCT01643928|P4|Participant Flow|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132569|NCT01643928|P3|Participant Flow|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132591|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
134452|NCT01637935|E1|Reported Event|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
132950|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
133442|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
132570|NCT01643928|P2|Participant Flow|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132571|NCT01643928|P1|Participant Flow|PF-05280586/PF-05280586/PF-05280586|This group received intravenous (IV) rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132572|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132573|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132574|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132575|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132576|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132577|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132578|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132579|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132592|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132580|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132581|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132582|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132583|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132584|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132585|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132586|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132587|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132588|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132589|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132590|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132943|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
134453|NCT01637922|B3|Baseline|Total|Total of all reporting groups
132593|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132594|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132595|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132596|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132597|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132598|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132599|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132600|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132601|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132602|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132603|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132944|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132604|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132605|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132606|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132607|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132608|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132609|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132610|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132611|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132612|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132613|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132614|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132945|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132615|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132616|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132617|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132618|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132619|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132620|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132621|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132622|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132623|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132624|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132625|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132626|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132627|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132628|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132629|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132630|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132631|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132632|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132633|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132634|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132635|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132636|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132946|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132947|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
135358|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
132637|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132638|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132639|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132640|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132641|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132642|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132643|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132644|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132645|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132646|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132647|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132888|NCT01643668|E1|Reported Event|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132648|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132649|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132650|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132651|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132652|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132653|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132654|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132655|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132656|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132657|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132658|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132659|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132660|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132661|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132662|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132663|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132664|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132665|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132666|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132667|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132668|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132669|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132889|NCT01643616|B3|Baseline|Total|Total of all reporting groups
132890|NCT01643616|B2|Baseline|Group NS|"Nerve stimulation technique:
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
132670|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132671|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132672|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132673|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132674|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132675|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132676|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132677|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132678|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132679|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132680|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132891|NCT01643616|B1|Baseline|Group US|"Ultrasound guided block :
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
135598|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
132681|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132682|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132683|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132684|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132685|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132686|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132687|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132688|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132689|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132690|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132691|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132892|NCT01643616|P2|Participant Flow|Group NS|"Nerve stimulation technique:
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
132893|NCT01643616|P1|Participant Flow|Group US|"Ultrasound guided block :
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
132894|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
132692|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132693|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132694|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132695|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132696|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132697|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132698|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132699|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132700|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132701|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132702|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132703|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132704|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132705|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132706|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132707|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132708|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132709|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132710|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132711|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132712|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132713|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132895|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
145160|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
132714|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132715|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132716|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132717|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132718|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132719|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132720|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132721|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132722|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132723|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132724|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132896|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
132897|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
132898|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
132725|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132726|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132727|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132728|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132729|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132730|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132731|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132732|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132733|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132734|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132735|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132899|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
135599|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
132736|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132737|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132738|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132739|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132740|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132741|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132742|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132743|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132744|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132745|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132746|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132747|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132748|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132749|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132750|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132751|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132752|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132753|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132754|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132755|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132756|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132757|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132900|NCT01643616|E2|Reported Event|Group NS|"Nerve stimulation technique:
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
132901|NCT01643616|E1|Reported Event|Group US|"Ultrasound guided block :
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
132902|NCT01643213|B3|Baseline|Total|Total of all reporting groups
132758|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132759|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132760|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132761|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132762|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132763|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132764|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132765|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132766|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132767|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132768|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132903|NCT01643213|B2|Baseline|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
132904|NCT01643213|B1|Baseline|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
132769|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132770|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132771|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132772|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132773|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132774|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132775|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132776|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132777|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132778|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132779|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132905|NCT01643213|P2|Participant Flow|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
132906|NCT01643213|P1|Participant Flow|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
132780|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132781|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132782|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132783|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132784|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132785|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132786|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132787|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132788|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132789|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132790|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132907|NCT01643213|O2|Outcome|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
132908|NCT01643213|O1|Outcome|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
132791|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132792|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132793|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132794|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132795|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132796|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132797|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132798|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132799|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132800|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132801|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132909|NCT01643213|E2|Reported Event|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
132910|NCT01643213|E1|Reported Event|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
132802|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132803|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132804|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132805|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132806|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132807|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132808|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132809|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132810|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132811|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132812|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
132813|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132814|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132815|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
132816|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132817|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132818|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132819|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
132820|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132821|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132822|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
132823|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132824|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132825|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132826|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
132911|NCT01643044|B3|Baseline|Total|Total of all reporting groups
132948|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
145161|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
132827|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132828|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132829|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
132830|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132831|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132832|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132833|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
132834|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132835|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
132836|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
132837|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132838|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
132839|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
132840|NCT01643928|E15|Reported Event|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132841|NCT01643928|E14|Reported Event|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132842|NCT01643928|E13|Reported Event|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132843|NCT01643928|E12|Reported Event|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132844|NCT01643928|E11|Reported Event|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132845|NCT01643928|E10|Reported Event|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132846|NCT01643928|E9|Reported Event|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132847|NCT01643928|E8|Reported Event|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132848|NCT01643928|E7|Reported Event|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132849|NCT01643928|E6|Reported Event|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132912|NCT01643044|B2|Baseline|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
134023|NCT01639833|O1|Outcome|Veriset™ Hemostatic Patch|"Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat"
132850|NCT01643928|E5|Reported Event|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132851|NCT01643928|E4|Reported Event|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
132852|NCT01643928|E3|Reported Event|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132853|NCT01643928|E2|Reported Event|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132854|NCT01643928|E1|Reported Event|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
132855|NCT01643902|B1|Baseline|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria
IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
132856|NCT01643902|P1|Participant Flow|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria
rt-PA: IV rt-PA 0.9 mg/kg minimum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target foor to needle time of 60 minutes or less from ED arrival."
132857|NCT01643902|O1|Outcome|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria
IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
132858|NCT01643902|O1|Outcome|IV Rt-PA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria
IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from Emergency department (ED) arrival."
132859|NCT01643902|E1|Reported Event|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria
IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
132860|NCT01643876|B1|Baseline|Palatal Brushing|"Palatal brushing after each meal for 3 months.
Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
132861|NCT01643876|P1|Participant Flow|Palatal Brushing|"Palatal brushing after each meal for 3 months.
Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
132862|NCT01643876|O1|Outcome|Palatal Brushing|"Palatal brushing after each meal for 3 months.
Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
132863|NCT01643876|O1|Outcome|Palatal Brushing|"Palatal brushing after each meal for 3 months.
Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
132864|NCT01643876|E1|Reported Event|Palatal Brushing|"Palatal brushing after each meal for 3 months.
Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
132949|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132865|NCT01643798|B1|Baseline|Pretreatment & Stimulation|Outside of the 3T magnetic resonance imaging (MRI) scanner, participants underwent resting motor threshold assessment, left dorsolateral prefrontal cortex localization and preliminary pain testing. Next, participants were placed in the scanner for baseline pain testing. After baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive approximately 10 ml intravenous naloxone (0.1mg/kg) or saline immediately prior to 20 minutes of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20 minutes of real left DLPFC rTMS. Participants then returned to the scanner for the final block test.
132866|NCT01643798|P2|Participant Flow|Naloxone and Stimulation, Then Saline and Stimulation|Participants received an intravenous infusion of 0.1mg/kg Naloxone immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. One week later, participants received an intravenous infusion of 10ml sterile saline immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex
132867|NCT01643798|P1|Participant Flow|Saline and Stimulation, Then Naloxone and Stimulation|Participants received an intravenous infusion of 10ml sterile saline immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. One week later, participants received an intravenous infusion of 0.1 mg/kg Naloxone immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex
132868|NCT01643798|O4|Outcome|Real rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
132869|NCT01643798|O3|Outcome|Sham rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
132870|NCT01643798|O2|Outcome|Real rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
132871|NCT01643798|O1|Outcome|Sham rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
132872|NCT01643798|O4|Outcome|Real rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
132873|NCT01643798|O3|Outcome|Sham rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
132938|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132939|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132940|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132874|NCT01643798|O2|Outcome|Real rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
132875|NCT01643798|O1|Outcome|Sham rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
132876|NCT01643798|E1|Reported Event|Pretreatment & Stimulation|
132877|NCT01643668|B1|Baseline|BuClo RIC + SCT|"BuClo RIC SCT
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132878|NCT01643668|P1|Participant Flow|BuClo RIC + SCT|"BuClo RIC SCT
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132879|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132880|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132881|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132882|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132883|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132884|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132885|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132886|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132887|NCT01643668|O1|Outcome|Treatment Arm|"Reduced Intensity Conditioning with Busulfan/Clofarabine followed by Allogeneic Stem Cell Transplantation (BuClo RIC SCT)
Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy"
132941|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
134024|NCT01639833|O2|Outcome|TachoSil®|"Topical Hemostat
TachoSil®: Topical Hemostat"
132913|NCT01643044|B1|Baseline|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.
Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
132914|NCT01643044|P2|Participant Flow|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
132915|NCT01643044|P1|Participant Flow|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.
Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
132916|NCT01643044|O2|Outcome|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
132917|NCT01643044|O1|Outcome|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.
Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
132918|NCT01643044|E2|Reported Event|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
132919|NCT01643044|E1|Reported Event|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.
Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
132920|NCT01642914|B4|Baseline|Total|Total of all reporting groups
132921|NCT01642914|B3|Baseline|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132922|NCT01642914|B2|Baseline|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132923|NCT01642914|B1|Baseline|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132924|NCT01642914|P3|Participant Flow|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132925|NCT01642914|P2|Participant Flow|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132926|NCT01642914|P1|Participant Flow|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132927|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132928|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132929|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast
132930|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132931|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132932|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132933|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132934|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132935|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132936|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132937|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
134025|NCT01639833|O1|Outcome|Veriset™ Hemostatic Patch|"Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat"
132951|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132952|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132953|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132954|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132955|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132956|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132957|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132958|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132959|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132960|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132961|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132962|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132963|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132964|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132965|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132966|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132967|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132968|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132969|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132970|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132971|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132972|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132973|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132974|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132975|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132976|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132977|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132978|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132979|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132980|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132981|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132982|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132983|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132984|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132985|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132986|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132987|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132988|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
136587|NCT01627002|E2|Reported Event|Part A PA401 0.3 mg|
132989|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132990|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132991|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132992|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132993|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132994|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132995|NCT01642914|O2|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132996|NCT01642914|O1|Outcome|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132997|NCT01642914|E3|Reported Event|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms
Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132998|NCT01642914|E2|Reported Event|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms
Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
132999|NCT01642914|E1|Reported Event|Placebo|"Matching placebo
Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
133000|NCT01642732|B1|Baseline|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.
Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).
Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.
Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.
Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
133001|NCT01642732|P1|Participant Flow|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.
Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).
Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.
Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.
Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
133002|NCT01642732|O1|Outcome|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.
Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).
Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.
Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.
Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
133003|NCT01642732|O1|Outcome|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.
Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).
Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.
Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.
Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
133004|NCT01642732|E1|Reported Event|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.
Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).
Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.
Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.
Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
133439|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
133441|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
133005|NCT01642615|B1|Baseline|All Participants|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks in the Open Label Healing Phase. Participants with healing of EE were eligible to participate in the Maintenance Phase.
133006|NCT01642615|P3|Participant Flow|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
133007|NCT01642615|P2|Participant Flow|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
133008|NCT01642615|P1|Participant Flow|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
133009|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
133010|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
133011|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
133012|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
133013|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
133014|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
133015|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
133016|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
133017|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
133018|NCT01642615|E3|Reported Event|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
133019|NCT01642615|E2|Reported Event|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
133020|NCT01642615|E1|Reported Event|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
133021|NCT01642602|B1|Baseline|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
133022|NCT01642602|P1|Participant Flow|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
133023|NCT01642602|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
133024|NCT01642602|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
133025|NCT01642602|E1|Reported Event|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
133026|NCT01642589|B3|Baseline|Total|Total of all reporting groups
133027|NCT01642589|B2|Baseline|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
133028|NCT01642589|B1|Baseline|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
133029|NCT01642589|P2|Participant Flow|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
133030|NCT01642589|P1|Participant Flow|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
133031|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
133032|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
133033|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
133034|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
133035|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
133036|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
133037|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
133038|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
133039|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
133040|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
133041|NCT01642589|E2|Reported Event|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
133042|NCT01642589|E1|Reported Event|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
133440|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133043|NCT01642485|B1|Baseline|All Study Participants|Subjects participating in the study attended for screening, two treatment periods (periods 1 and 2) of 4 assessment days each and a follow-up visit. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in fasted condition or with Continental breakfast, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. No wash-out was required between the other treatments investigated. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
133044|NCT01642485|P8|Participant Flow|Sequence 8|"Period1:
Day 1: FDA breakfast Day 2: Placebo Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days
Period 2:
Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxifloxacin 400 mg fasted"
133045|NCT01642485|P7|Participant Flow|Sequence 7|"Period1:
Day 1: Continental breakfast Day 2: FDA breakfast Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days
Period 2:
Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxifloxacin 400 mg fasted"
133046|NCT01642485|P6|Participant Flow|Sequence 6|"Period1:
Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days
Period 2:
Day 1: FDA breakfast Day 2: Placebo Day 3: Moxifloxacin 400 mg fasted"
133047|NCT01642485|P5|Participant Flow|Sequence 5|"Period1:
Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days
Period 2:
Day 1: Continental breakfast Day 2:FDA breakfast Day 3: Moxifloxacin 400 mg fasted"
133048|NCT01642485|P4|Participant Flow|Sequence 4|"Period1:
Day 1: FDA breakfast Day 2: Placebo Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days
Period 2:
Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
133049|NCT01642485|P3|Participant Flow|Sequence 3|"Period1:
Day 1: Continental breakfast Day 2: FDA breakfast Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days
Period 2:
Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
133050|NCT01642485|P2|Participant Flow|Sequence 2|"Period1:
Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days
Period 2:
Day 1: FDA breakfast Day 2: Placebo Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
133051|NCT01642485|P1|Participant Flow|Sequence 1|"Period1:
Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days
Period 2:
Day 1: Continental breakfast Day 2:FDA breakfast Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
133052|NCT01642485|O4|Outcome|Japanese Fed Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
133053|NCT01642485|O3|Outcome|Japanese Fasted Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
133054|NCT01642485|O2|Outcome|Caucasian Fed Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
133055|NCT01642485|O1|Outcome|Caucasian Fasted Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (1h)
133056|NCT01642485|O3|Outcome|C-peptide|A euglycaemic/hyperinsulinaemic clamp involves acutely raising the plasma insulin levels to a steady state and maintaining a state of euglycaemia with a glucose infusion, thereby effectively stopping endogenous glucose and insulin production, and as a result reducing the release of C-peptides. This technique will firstly test whether hyperinsulinaemia has an effect on QT interval, and secondly whether C-peptide levels play any role in the proposed effect on the QT interval.
133057|NCT01642485|O2|Outcome|Glucose|A euglycaemic/hyperinsulinaemic clamp was used to stop any endogenous C-peptide and insulin production. The clamp acutely raised the plasma insulin concentrations to a steady-state and maintained glucose concentrations at/or slightly lower than the individual subjects baseline reading. For each subject two 18G cannulas were inserted, one in the antecubital fossa for insulin and glucose infusions, and one for pharmacokinetic (PK) and blood glucose sampling.
133058|NCT01642485|O1|Outcome|Insulin Clamp|A euglycaemic/hyperinsulinaemic clamp was used to stop any endogenous C-peptide and insulin production. The clamp acutely raised the plasma insulin concentrations to a steady-state and maintained glucose concentrations at/or slightly lower than the individual subjects baseline reading. For each subject two 18G cannulas were inserted, one in the antecubital fossa for insulin and glucose infusions, and one for pharmacokinetic (PK) and blood glucose sampling.
133059|NCT01642485|O2|Outcome|Placebo|Time matched absolute value for QTcF for placebo treatment.
133060|NCT01642485|O1|Outcome|Moxifloxacin 400 mg Fasted|The highest change was at 2.5h time point, which is presented here.
133061|NCT01642485|O3|Outcome|Placebo at Baseline|a baseline QTcF measured on Day -1 of each period
133062|NCT01642485|O2|Outcome|Continental Breakfast|"Continental breakfast: High carbohydrate breakfast (>70% carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a greater effect on QTc compared to a low carbohydrate breakfast (FDA standard breakfast) should be observed.
QTcF change from a baseline presented."
133063|NCT01642485|O1|Outcome|FDA Breakfast|FDA breakfast: Calorie reduced FDA standard breakfast (58% fat, low carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a lesser effect on QTc compared to a carbohydrate rich breakfast should be observed.
133080|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133081|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133064|NCT01642485|O2|Outcome|Fed Group|This study was designed as an open-label, randomized, placebo-controlled, crossover trial that evaluated the effect of a 400 mg oral dose of moxifloxacin in fed conditions to a baseline and a placebo treatment. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in either the fed or fasted condition, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
133065|NCT01642485|O1|Outcome|Fasted Group|This study was designed as an open-label, randomized, placebo-controlled, crossover trial that evaluated the effect of a 400 mg oral dose of moxifloxacin in fasted conditions to a baseline and a placebo treatment. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in either the fed or fasted condition, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
133066|NCT01642485|E2|Reported Event|Moxifloxacin 400 mg Fed|"Moxifloxacin with food: Currently, there is no published data showing the effects of a single 400 mg oral dose of moxifloxacin on the ECG/QT/QTc after food.
No significant other Adverse Events have been reported."
133067|NCT01642485|E1|Reported Event|Moxifloxacin 400 mg Fasted|"Moxifloxacin fasted: One single dose of 400mg moxifloxacin after fasting - This is the standard probe for the assessment of assay sensitivity in Thorough QT (TQT) studies.
No significant other Adverse Events have been reported."
133068|NCT01642407|B1|Baseline|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133069|NCT01642407|P1|Participant Flow|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133070|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133071|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133072|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133073|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133074|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133075|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133076|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133077|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133078|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133079|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133162|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133082|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133083|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133084|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133085|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133086|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133087|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133088|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133089|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133090|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133091|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133092|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133093|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133094|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133095|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133096|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133097|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133098|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133099|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133277|NCT01641991|P1|Participant Flow|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133100|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133101|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133102|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133103|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133104|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133105|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133106|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133107|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133108|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133109|NCT01642407|E1|Reported Event|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
133110|NCT01642277|B3|Baseline|Total|Total of all reporting groups
133111|NCT01642277|B2|Baseline|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
133112|NCT01642277|B1|Baseline|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5mg daily solifenacin (with an option to increase to 10mg daily solifenacin at 4 weeks) for the treatment of urinary urge incontinence (UUI).
133113|NCT01642277|P2|Participant Flow|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
133114|NCT01642277|P1|Participant Flow|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
133115|NCT01642277|O2|Outcome|Solifenacin Non-Responder|Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
133116|NCT01642277|O1|Outcome|Solifenacin Responder|Individuals with urinary urge incontinence who responded to solifenacin at 12 weeks
133117|NCT01642277|O2|Outcome|Solifenacin Non-Responder|Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
133118|NCT01642277|O1|Outcome|Solifenacin Responder|Individuals with urinary urge incontinence who responded to solifenacin at 12 weeks
133119|NCT01642277|O1|Outcome|Urinary Urge Incontinence|Women who received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
133120|NCT01642277|E2|Reported Event|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
133121|NCT01642277|E1|Reported Event|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
133122|NCT01642238|B1|Baseline|Antithrombotic Effects|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) using a randomized, two-treatment, two-period, cross-over design in healthy volunteers.
133123|NCT01642238|P2|Participant Flow|Clopidogrel, Then Ticagrelor|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
133124|NCT01642238|P1|Participant Flow|Ticagrelor, Then Clopidogrel|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
133948|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
133125|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133126|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133127|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133128|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133129|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133130|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133131|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133132|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133133|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133134|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133135|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133136|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133137|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133138|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133139|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
145162|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
133140|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
133141|NCT01642238|E2|Reported Event|Clopidogrel, Then Ticagrelor|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between.
133142|NCT01642238|E1|Reported Event|Ticagrelor, Then Clopidogrel|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between.
133143|NCT01642212|B3|Baseline|Total|Total of all reporting groups
133144|NCT01642212|B2|Baseline|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133145|NCT01642212|B1|Baseline|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133146|NCT01642212|P5|Participant Flow|Oral Budesonide Suspension (OBS) 2 mg to Open-label OBS 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
133147|NCT01642212|P4|Participant Flow|Placebo to Open-label Oral Budesonide Suspension (OBS) 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
133148|NCT01642212|P3|Participant Flow|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133149|NCT01642212|P2|Participant Flow|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133150|NCT01642212|P1|Participant Flow|Single-blind Placebo|Eligible participants entered a 4-week, single-blind, placebo baseline period. Participants ingested the first dose of placebo in the clinic in the presence of study center personnel, and the remaining doses were ingested at home. Participants took placebo twice daily (bid); once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133151|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133152|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133153|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133154|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133155|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133156|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133157|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133158|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133159|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133160|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133161|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133949|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
133163|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133164|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133165|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133166|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133167|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133168|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133169|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133170|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133171|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133172|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133173|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133174|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133175|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133176|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133177|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133178|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133179|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133180|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133181|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133182|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133183|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133184|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133185|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133186|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133187|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133950|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
133188|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133189|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133190|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133191|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133192|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133193|NCT01642212|E4|Reported Event|Oral Budesonide Suspension (OBS) 2 mg to Open-label OBS 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
133194|NCT01642212|E3|Reported Event|Placebo to Open-label Oral Budesonide Suspension (OBS) 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
133195|NCT01642212|E2|Reported Event|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2mg OBS (formulation MB-9) 2 mg twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133196|NCT01642212|E1|Reported Event|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
133197|NCT01642147|B3|Baseline|Total|Total of all reporting groups
133198|NCT01642147|B2|Baseline|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133199|NCT01642147|B1|Baseline|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133200|NCT01642147|P2|Participant Flow|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133201|NCT01642147|P1|Participant Flow|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133202|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133203|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133204|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133205|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133206|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133207|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133208|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133209|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133210|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133211|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133212|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133213|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133214|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133215|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133216|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133217|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133218|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133219|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133220|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133221|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133222|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133223|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133224|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133225|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.
Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
133226|NCT01642147|E2|Reported Event|Craniotomy Group|Randomly chosen patients undergoing selective craniotomy surgery. Transcranial Doppler measures,jugular venous bulb catheterization, radial artery catheterization, and craniotomy under general anesthesia will be performed.
133227|NCT01642147|E1|Reported Event|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
133228|NCT01642082|B1|Baseline|Treatment (Dalantercept)|"Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Dalantercept: Given SC
Laboratory Biomarker Analysis: Correlative studies"
133229|NCT01642082|P1|Participant Flow|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
133230|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
133231|NCT01642082|O1|Outcome|Treatment (Dalantercept)|"Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Dalantercept: Given SC
Laboratory Biomarker Analysis: Correlative studies"
133232|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
133252|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133233|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
133234|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
133235|NCT01642082|E1|Reported Event|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.
Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.
A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
133236|NCT01642004|B3|Baseline|Total|Total of all reporting groups
133237|NCT01642004|B2|Baseline|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133238|NCT01642004|B1|Baseline|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133239|NCT01642004|P2|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133240|NCT01642004|P1|Participant Flow|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133241|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133242|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133243|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133244|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133245|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133246|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133247|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133248|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133249|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133250|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133251|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133253|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133254|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133255|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133256|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133257|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133258|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133259|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133260|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133261|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133262|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133263|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133264|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133265|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133266|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133267|NCT01642004|E2|Reported Event|DOCETAXEL|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133268|NCT01642004|E1|Reported Event|NIVOLUMAB|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
133269|NCT01641991|B5|Baseline|Total|Total of all reporting groups
133270|NCT01641991|B4|Baseline|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133271|NCT01641991|B3|Baseline|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133272|NCT01641991|B2|Baseline|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133273|NCT01641991|B1|Baseline|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133274|NCT01641991|P4|Participant Flow|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133275|NCT01641991|P3|Participant Flow|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133276|NCT01641991|P2|Participant Flow|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133951|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
133278|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133279|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133280|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133281|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133282|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133283|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133284|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133285|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133286|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133287|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133288|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133289|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133290|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133291|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133292|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133293|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133294|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133295|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133296|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133297|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133298|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133299|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133300|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133301|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133302|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133303|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133304|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133305|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133306|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133307|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133308|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133309|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133310|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133311|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133312|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133313|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133314|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133315|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133316|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133317|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
134026|NCT01639833|E2|Reported Event|TachoSil®|"Topical Hemostat
TachoSil®: Topical Hemostat"
133318|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133319|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133320|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133321|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133322|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133323|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133324|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133325|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133326|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133327|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133328|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133329|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133330|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133331|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133332|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133333|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133334|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133335|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133336|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133337|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133338|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133339|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133340|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133341|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133342|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133343|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133344|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133345|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133346|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133347|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133348|NCT01641991|E4|Reported Event|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133349|NCT01641991|E3|Reported Event|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133350|NCT01641991|E2|Reported Event|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
133351|NCT01641991|E1|Reported Event|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
133352|NCT01641978|B1|Baseline|Neurologic Level|Neurologic patients
133353|NCT01641978|P1|Participant Flow|Neurologic Level|Neurologic patients
133354|NCT01641978|O1|Outcome|Critical Care Time Experience|Influence of work experience in the evaluation of neurological patients
133355|NCT01641978|O3|Outcome|Slight|patients with GCS > 12 points
133356|NCT01641978|O2|Outcome|Moderate|patients with GCS 9 - 12 points
133357|NCT01641978|O1|Outcome|Severe|patients with GCS < 9 points
133358|NCT01641978|O1|Outcome|Neurologic Level|Neurologic patients
133359|NCT01641978|E1|Reported Event|Neurologic Level|Neurologic patients
133360|NCT01641952|B1|Baseline|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133952|NCT01640314|E2|Reported Event|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
133361|NCT01641952|P1|Participant Flow|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133362|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133363|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133364|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133365|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133366|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133367|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133368|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133369|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133370|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133371|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133372|NCT01641952|E1|Reported Event|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
133373|NCT01641939|B4|Baseline|Total|Total of all reporting groups
133374|NCT01641939|B3|Baseline|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133375|NCT01641939|B2|Baseline|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133376|NCT01641939|B1|Baseline|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133377|NCT01641939|P3|Participant Flow|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133378|NCT01641939|P2|Participant Flow|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133379|NCT01641939|P1|Participant Flow|Standard Taxane Therapy|Docetaxel was administered at 75 milligram per meter square (mg/m^2) intravenously (IV) on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133380|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133381|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133382|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133383|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133437|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
135600|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
133384|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133385|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133386|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133387|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133388|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133389|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133390|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133391|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133392|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133393|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133394|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133395|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133396|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133397|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133398|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133399|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133400|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133401|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133402|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133403|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133404|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133438|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133405|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133406|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133407|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133408|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133409|NCT01641939|O3|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133410|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133411|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133412|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133413|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133414|NCT01641939|E3|Reported Event|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133415|NCT01641939|E2|Reported Event|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133416|NCT01641939|E1|Reported Event|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
133417|NCT01641926|B5|Baseline|Total|Total of all reporting groups
133418|NCT01641926|B4|Baseline|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133419|NCT01641926|B3|Baseline|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
133420|NCT01641926|B2|Baseline|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133421|NCT01641926|B1|Baseline|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
133422|NCT01641926|P4|Participant Flow|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133423|NCT01641926|P3|Participant Flow|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
133424|NCT01641926|P2|Participant Flow|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133425|NCT01641926|P1|Participant Flow|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
133426|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133427|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
133428|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133429|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
133430|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133431|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
133432|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133433|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
133434|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133435|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
133436|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
145163|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
133443|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
133444|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133445|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
133446|NCT01641926|E4|Reported Event|HBeAG(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133447|NCT01641926|E3|Reported Event|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
133448|NCT01641926|E2|Reported Event|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
133449|NCT01641926|E1|Reported Event|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
133450|NCT01641900|B3|Baseline|Total|Total of all reporting groups
133451|NCT01641900|B2|Baseline|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
133452|NCT01641900|B1|Baseline|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
133453|NCT01641900|P2|Participant Flow|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
133454|NCT01641900|P1|Participant Flow|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
133455|NCT01641900|O2|Outcome|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
133456|NCT01641900|O1|Outcome|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
133457|NCT01641900|O2|Outcome|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
133458|NCT01641900|O1|Outcome|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
133459|NCT01641900|E4|Reported Event|3mg Eszopiclone Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.Participants who completed Drug Intervention.
133460|NCT01641900|E3|Reported Event|3mg Eszopiclone With Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants who completed Drug Intervention.
133461|NCT01641900|E2|Reported Event|Placebo Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.Participants who completed Placebo Intervention.
133462|NCT01641900|E1|Reported Event|Placebo With Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants who completed Placebo Intervention.
133463|NCT01641861|B3|Baseline|Total|Total of all reporting groups
133464|NCT01641861|B2|Baseline|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.
Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
133465|NCT01641861|B1|Baseline|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.
Conventional method: caries removal by using rotary instrument."
133466|NCT01641861|P2|Participant Flow|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.
Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
133467|NCT01641861|P1|Participant Flow|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.
Conventional method: caries removal by using rotary instrument."
133468|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.
Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
133469|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.
Conventional method: caries removal by using rotary instrument."
133470|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.
Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
133471|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.
Conventional method: caries removal by using rotary instrument."
133472|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.
Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
133473|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.
Conventional method: caries removal by using rotary instrument."
135606|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
133474|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.
Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
133475|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.
Conventional method: caries removal by using rotary instrument."
133476|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.
Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
133477|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.
Conventional method: caries removal by using rotary instrument."
133478|NCT01641861|E2|Reported Event|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.
Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
133479|NCT01641861|E1|Reported Event|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.
Conventional method: caries removal by using rotary instrument."
133480|NCT01641835|B1|Baseline|Normals|No eye disease.
133481|NCT01641835|P1|Participant Flow|Normals|No eye disease.
133482|NCT01641835|O1|Outcome|Healthy Volunteers|Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve
133483|NCT01641835|O1|Outcome|Healthy Volunteers|Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve
133484|NCT01641835|E1|Reported Event|Normals|No adverse events were reported.
133485|NCT01641822|B3|Baseline|Total|Total of all reporting groups
133486|NCT01641822|B2|Baseline|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133487|NCT01641822|B1|Baseline|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133488|NCT01641822|P3|Participant Flow|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133489|NCT01641822|P2|Participant Flow|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133490|NCT01641822|P1|Participant Flow|TIS Run-In Treatment Group|Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase.
133491|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133492|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133493|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133494|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133495|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133496|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133497|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133498|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133499|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133500|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133501|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133502|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133503|NCT01641822|E3|Reported Event|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133953|NCT01640314|E1|Reported Event|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
133504|NCT01641822|E2|Reported Event|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
133505|NCT01641822|E1|Reported Event|TIS Run-In Treatment Group|Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase.
133506|NCT01641692|B1|Baseline|All Study Treatments|"The treatment phase was comprised of three 14-day treatment periods. Treatment Period 1 and 2 were followed by a 12-14 day washout period. Treatment Period 3 was followed by a 5 to 9 day washout period before the Follow-up visit. Participants were randomly assigned to receive a sequence of 3 of the 8 active treatments :
UMEC 15.6, 31.25, 62.5, 125, 250 µg QD and UMEC 15.6, 31.25 µg BID, placebo."
133507|NCT01641692|P8|Participant Flow|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133508|NCT01641692|P7|Participant Flow|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133509|NCT01641692|P6|Participant Flow|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133510|NCT01641692|P5|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133511|NCT01641692|P4|Participant Flow|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133512|NCT01641692|P3|Participant Flow|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133513|NCT01641692|P2|Participant Flow|UMEC 15.6 µg QD|Participants received umeclidinium bromide (UMEC) 15.6 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133514|NCT01641692|P1|Participant Flow|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
133515|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133516|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133517|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133518|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133519|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133520|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133521|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133522|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133523|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133524|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133525|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133526|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133527|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133528|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133529|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133530|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133531|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133532|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133533|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133534|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133535|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133536|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133537|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133538|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133539|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133540|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133541|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133542|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133543|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133544|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133545|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133546|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133547|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133548|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133549|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133550|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133551|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133552|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133553|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133554|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133555|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133556|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133557|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133558|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133559|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133560|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133561|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133562|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133563|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133564|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133565|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133566|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133567|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133568|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133569|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133570|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133571|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133572|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133573|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133574|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133575|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133576|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133577|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133578|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133579|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133580|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133581|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133582|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133583|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133584|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133585|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133586|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133587|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133588|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133589|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133590|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133591|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133592|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133593|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133594|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133595|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133596|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133597|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133598|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133599|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133600|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133601|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133602|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133603|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133604|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133605|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133606|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133607|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133608|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133609|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133610|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133611|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133612|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133613|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133614|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133615|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133616|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133617|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133618|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133619|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133620|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133621|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133622|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133623|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133624|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133625|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133626|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133627|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133628|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133629|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133630|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133631|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133632|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133633|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133634|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133635|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133636|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133637|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133638|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133639|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133640|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133641|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133642|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133643|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133644|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133645|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133646|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133647|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133648|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133649|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133650|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133651|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133652|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133653|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133654|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133655|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133656|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133657|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133658|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133659|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133660|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133661|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133662|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133663|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133664|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133665|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133666|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133667|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133668|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133669|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133670|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133671|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133672|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133673|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133674|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133675|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133676|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133677|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133678|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133679|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133680|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133681|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133682|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133683|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133684|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133685|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133686|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133687|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133688|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133689|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133690|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133691|NCT01641692|O1|Outcome|All Study Treatments|The treatment phase was comprised of three 14-day treatment periods. Treatment Period 1 and 2 were followed by a 12-14 day washout period. Treatment Period 3 was followed by a 5 to 9 day washout period before the Follow-up visit. Participants were randomly assigned to receive a sequence of 3 of the 8 active treatments : UMEC 15.6, 31.25, 62.5, 125, 250 µg QD and UMEC 15.6, 31.25 µg BID, placebo.
133692|NCT01641692|E8|Reported Event|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133693|NCT01641692|E7|Reported Event|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
133694|NCT01641692|E6|Reported Event|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133695|NCT01641692|E5|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133696|NCT01641692|E4|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133697|NCT01641692|E3|Reported Event|UMEC 31.5 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133698|NCT01641692|E2|Reported Event|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
133699|NCT01641692|E1|Reported Event|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
133700|NCT01641653|B3|Baseline|Total|Total of all reporting groups
133701|NCT01641653|B2|Baseline|Midazolam|"half of the patients will receive Midazolam prior to entering the OR
Midazolam: 1-2.5 mg"
133702|NCT01641653|B1|Baseline|Placebo|"half of the patients will receive placebo (normal saline) prior to entering the OR
Normal saline: Normal saline 2cc. one dose prior to OR"
133703|NCT01641653|P2|Participant Flow|Midazolam|"half of the patients will receive Midazolam prior to entering the OR
Midazolam: 1-2.5 mg"
133704|NCT01641653|P1|Participant Flow|Placebo|"half of the patients will receive placebo (normal saline 2mL) prior to entering the OR
Normal saline: Normal saline 2cc. one dose prior to OR"
133705|NCT01641653|O2|Outcome|Midazolam|subjects will receive midazolam 1.5-2mg prior to entering the OR
133706|NCT01641653|O1|Outcome|Placebo|subjects will receive 2cc. Normal Saline prior to entering the OR
133707|NCT01641653|O2|Outcome|Midazolam|half of subjects will receive Midazolam: 1-2.5 mgIV prior to entering the OR
133708|NCT01641653|O1|Outcome|Placebo|Normal saline: Normal saline 2cc. IV one dose prior to OR
133709|NCT01641653|O2|Outcome|Midazolam|One half of subjects will recieveMidazolam: 1-2.5 mg IV
133710|NCT01641653|O1|Outcome|Placebo|Normal saline: Normal saline 2cc. IV one dose prior to OR
133711|NCT01641653|E2|Reported Event|Midazolam|"half of the patients will receive Midazolam prior to entering the OR
Midazolam: 1-2.5 mg"
133712|NCT01641653|E1|Reported Event|Placebo|"half of the patients will receive placebo (normal saline) prior to entering the OR
Normal saline: Normal saline 2cc. one dose prior to OR"
133713|NCT01641640|B1|Baseline|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
133714|NCT01641640|P1|Participant Flow|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+pegylated interferon alfa 2a (PEG)+ribavirin (RBV) for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
133715|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
133716|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
133954|NCT01640197|B3|Baseline|Total|Total of all reporting groups
133717|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
135607|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
133718|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
133719|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
133720|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
133721|NCT01641640|E1|Reported Event|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
133722|NCT01641471|B3|Baseline|Total|Total of all reporting groups
133723|NCT01641471|B2|Baseline|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.
Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
133724|NCT01641471|B1|Baseline|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.
EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
133725|NCT01641471|P2|Participant Flow|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.
Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
133726|NCT01641471|P1|Participant Flow|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.
EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
133727|NCT01641471|O2|Outcome|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.
Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
133728|NCT01641471|O1|Outcome|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.
EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
133746|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133729|NCT01641471|E2|Reported Event|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.
Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
133730|NCT01641471|E1|Reported Event|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.
EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
133731|NCT01641237|B1|Baseline|All Randomized Participants|All randomized participants who received at least one dose of the study treatments.
133732|NCT01641237|P4|Participant Flow|Placebo Dentifrice (0ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133733|NCT01641237|P3|Participant Flow|NaF Dentifrice (250ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133734|NCT01641237|P2|Participant Flow|NaF Dentifrice (1150ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133735|NCT01641237|P1|Participant Flow|Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 grams (g) ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133736|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133737|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133738|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133739|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133740|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133741|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133742|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133743|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133744|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133745|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
135601|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
133747|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133748|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133749|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133750|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133751|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
133752|NCT01641237|E4|Reported Event|Placebo Dentifrice (0 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated.
133753|NCT01641237|E3|Reported Event|NaF Dentifrice (250 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated.
133754|NCT01641237|E2|Reported Event|NaF Dentifrice (1150 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated.
133755|NCT01641237|E1|Reported Event|NaF Dentifrice (1426 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated.
133756|NCT01641159|B3|Baseline|Total|Total of all reporting groups
133757|NCT01641159|B2|Baseline|Placebo Plus TAU|"Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
133758|NCT01641159|B1|Baseline|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
133759|NCT01641159|P2|Participant Flow|Placebo Plus TAU|"Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
133760|NCT01641159|P1|Participant Flow|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
133761|NCT01641159|O2|Outcome|Placebo Plus TAU|"Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
133762|NCT01641159|O1|Outcome|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
133763|NCT01641159|O2|Outcome|Placebo Plus TAU|"Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
133764|NCT01641159|O1|Outcome|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
133765|NCT01641159|E2|Reported Event|Placebo Plus TAU|"Placebo taken daily for the 15-week active study
Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
133766|NCT01641159|E1|Reported Event|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study
Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
133767|NCT01641133|B4|Baseline|Total|Total of all reporting groups
133955|NCT01640197|B2|Baseline|Placebo|"Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
145164|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
133768|NCT01641133|B3|Baseline|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133769|NCT01641133|B2|Baseline|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133770|NCT01641133|B1|Baseline|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133771|NCT01641133|P3|Participant Flow|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133772|NCT01641133|P2|Participant Flow|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133773|NCT01641133|P1|Participant Flow|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133774|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133775|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133776|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133777|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133778|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133779|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133780|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133781|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133782|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133783|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133784|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133785|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133786|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133787|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
134018|NCT01639833|B2|Baseline|TachoSil®|"Topical Hemostat
TachoSil®: Topical Hemostat"
145165|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
133788|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133789|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133790|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133791|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133792|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133793|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133794|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133795|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133796|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133797|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133798|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133799|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133800|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133801|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133802|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133803|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133804|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133805|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133806|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133807|NCT01641133|E3|Reported Event|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
134019|NCT01639833|B1|Baseline|Veriset™ Hemostatic Patch|"Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat"
133808|NCT01641133|E2|Reported Event|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
133809|NCT01641133|E1|Reported Event|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
133810|NCT01641120|B1|Baseline|All Study Participants|Avonex: Intramuscular injection administered using 30 gauge or 25 gauge needle
133811|NCT01641120|P1|Participant Flow|25 Gauge or 30 Gauge Needle|Avonex: Intramuscular injection administered using 25 gauge needle weeks 1, 4, and 5 and 30 gauge needle on weeks 2 and 3.
133812|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
133813|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
133814|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
133815|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
133816|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
133817|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
133818|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex for weeks 2 and 3 of the study.
133819|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
133820|NCT01641120|E2|Reported Event|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
133821|NCT01641120|E1|Reported Event|25 Gauge|The same subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
133822|NCT01641081|B1|Baseline|Overall Study Population|All patients participating in the crossover study
133823|NCT01641081|P10|Participant Flow|Sequence 10|Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Placebo Pressair
133824|NCT01641081|P9|Participant Flow|Sequence 9|12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; Placebo Pressair; Formoterol 6 μg Pressair
133825|NCT01641081|P8|Participant Flow|Sequence 8|24 μg Foradil Aerolizer; Placebo Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Formoterol 12 μg Pressair
133826|NCT01641081|P7|Participant Flow|Sequence 7|Placebo Pressair; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer
133827|NCT01641081|P6|Participant Flow|Sequence 6|Formoterol 6 μg Pressair; Formoterol 12 μg Pressair; Placebo Pressair; 12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer
133828|NCT01641081|P5|Participant Flow|Sequence 5|Placebo Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 12 μg Pressair
133829|NCT01641081|P4|Participant Flow|Sequence 4|Formoterol 6 μg Pressair; Placebo Pressair; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer
133830|NCT01641081|P3|Participant Flow|Sequence 3|Formoterol 12 μg Pressair; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Placebo Pressair; 24 μg Foradil Aerolizer
133831|NCT01641081|P2|Participant Flow|Sequence 2|12 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Placebo Pressair
133832|NCT01641081|P1|Participant Flow|Sequence 1|24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer; Placebo Pressair; Formoterol 12 μg Pressair; Formoterol 6 μg Pressair
133833|NCT01641081|O5|Outcome|Placebo|Administered via Pressair
133834|NCT01641081|O4|Outcome|Formoterol 6 μg|Administered via Pressair
133835|NCT01641081|O3|Outcome|Formoterol 12 μg|Administered via Pressair
133836|NCT01641081|O2|Outcome|Foradil 12 μg|Administered via Aerolizer
133837|NCT01641081|O1|Outcome|Foradil 24 μg|Administered via Aerolizer
133838|NCT01641081|O5|Outcome|Placebo|Administered via Pressair
133839|NCT01641081|O4|Outcome|Formoterol 6 μg|Administered via Pressair
133840|NCT01641081|O3|Outcome|Formoterol 12 μg|Administered via Pressair
133841|NCT01641081|O2|Outcome|Foradil 12 μg|Administered via Aerolizer
133842|NCT01641081|O1|Outcome|Foradil 24 μg|Administered via Aerolizer
133843|NCT01641081|E5|Reported Event|Placebo|Administered via Pressair
133844|NCT01641081|E4|Reported Event|Formoterol 6 μg|Administered via Pressair
133845|NCT01641081|E3|Reported Event|Formoterol 12 μg|Administered via Pressair
133846|NCT01641081|E2|Reported Event|Foradil 12 μg|Administered via Aerolizer
133847|NCT01641081|E1|Reported Event|Foradil 24 μg|Administered via Aerolizer
133848|NCT01640964|B4|Baseline|Total|Total of all reporting groups
133849|NCT01640964|B3|Baseline|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
133850|NCT01640964|B2|Baseline|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
133851|NCT01640964|B1|Baseline|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
133852|NCT01640964|P3|Participant Flow|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
133853|NCT01640964|P2|Participant Flow|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
136588|NCT01627002|E1|Reported Event|Part A PA401 0.1 mg|
133854|NCT01640964|P1|Participant Flow|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
133855|NCT01640964|O2|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
133856|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
133857|NCT01640964|O1|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
133858|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
133859|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
133860|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
133861|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
133862|NCT01640964|O1|Outcome|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
133863|NCT01640964|O1|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
133864|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
133865|NCT01640964|E3|Reported Event|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
133866|NCT01640964|E2|Reported Event|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
133867|NCT01640964|E1|Reported Event|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
133868|NCT01640925|B3|Baseline|Total|Total of all reporting groups
133869|NCT01640925|B2|Baseline|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
133870|NCT01640925|B1|Baseline|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.
Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
133871|NCT01640925|P2|Participant Flow|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
133872|NCT01640925|P1|Participant Flow|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.
Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
133873|NCT01640925|O2|Outcome|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
133874|NCT01640925|O1|Outcome|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.
Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
133875|NCT01640925|E2|Reported Event|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
133910|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133876|NCT01640925|E1|Reported Event|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.
Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
133877|NCT01640548|B1|Baseline|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133878|NCT01640548|P1|Participant Flow|Rheumatoid Arthritis (RA) Cohort|Participants on biologic disease modifying anti-rheumatic drug (bDMARD) monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133879|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133880|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133881|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133882|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133883|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133884|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133885|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133886|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133887|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133888|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133889|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133890|NCT01640548|E1|Reported Event|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
133891|NCT01640353|B1|Baseline|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
133892|NCT01640353|P1|Participant Flow|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
133893|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
133894|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
133895|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
133896|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
133897|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
133898|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
133899|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
133900|NCT01640353|E1|Reported Event|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
133901|NCT01640340|B3|Baseline|Total|Total of all reporting groups
133902|NCT01640340|B2|Baseline|Arm B|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
133903|NCT01640340|B1|Baseline|Arm A|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
133904|NCT01640340|P2|Participant Flow|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
133905|NCT01640340|P1|Participant Flow|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg days 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
133906|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133907|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133908|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133909|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133911|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133912|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133913|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133914|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133915|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133916|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133917|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133918|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133919|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
133920|NCT01640340|E2|Reported Event|Arm B|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
133921|NCT01640340|E1|Reported Event|Arm A|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
133922|NCT01640327|B3|Baseline|Total|Total of all reporting groups
133923|NCT01640327|B2|Baseline|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
133924|NCT01640327|B1|Baseline|18–60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
133925|NCT01640327|P2|Participant Flow|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
133926|NCT01640327|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
133927|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
133928|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
133929|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
133930|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
133931|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
133932|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
133933|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
133934|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
133935|NCT01640327|E2|Reported Event|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
133936|NCT01640327|E1|Reported Event|18–60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
133937|NCT01640314|B3|Baseline|Total|Total of all reporting groups
133938|NCT01640314|B2|Baseline|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
133939|NCT01640314|B1|Baseline|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
133940|NCT01640314|P2|Participant Flow|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
133941|NCT01640314|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
133942|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
133943|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
133944|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
133945|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
133946|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
133947|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
133956|NCT01640197|B1|Baseline|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
133957|NCT01640197|P2|Participant Flow|Placebo|"Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
133958|NCT01640197|P1|Participant Flow|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
133959|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
133960|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
133961|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
133962|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
133963|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
133964|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
133965|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
133966|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
133967|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
133968|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
133969|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
133970|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
133971|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
133972|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
133973|NCT01640197|E2|Reported Event|Placebo|"Methyl Cellulose administered in identical capsules as the active.
Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
133974|NCT01640197|E1|Reported Event|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.
Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
133975|NCT01640184|B4|Baseline|Total|Total of all reporting groups
133976|NCT01640184|B3|Baseline|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.
Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
133977|NCT01640184|B2|Baseline|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
133978|NCT01640184|B1|Baseline|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.
Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
133979|NCT01640184|P3|Participant Flow|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.
Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
133980|NCT01640184|P2|Participant Flow|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
133981|NCT01640184|P1|Participant Flow|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.
Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
134020|NCT01639833|P2|Participant Flow|TachoSil®|"Topical Hemostat
TachoSil®: Topical Hemostat"
133982|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.
Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
134027|NCT01639833|E1|Reported Event|Veriset™ Hemostatic Patch|"Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat"
133983|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
133984|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.
Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
133985|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.
Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
133986|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
133987|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.
Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
133988|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.
Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
133989|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
133990|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.
Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
133991|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.
Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
133992|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
133993|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.
Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
133994|NCT01640184|O2|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.
Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
133995|NCT01640184|O1|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
133996|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.
Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
134021|NCT01639833|P1|Participant Flow|Veriset™ Hemostatic Patch|"Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat"
134028|NCT01639755|B1|Baseline|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
134029|NCT01639755|P1|Participant Flow|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
133997|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
133998|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.
Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
133999|NCT01640184|E3|Reported Event|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.
Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
134000|NCT01640184|E2|Reported Event|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
134001|NCT01640184|E1|Reported Event|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.
Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
134002|NCT01640171|B1|Baseline|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel
Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.
Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment
Acuvail: Anti-inflammatory drop given after treatment
Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion
Fellow Eye:
Eye receiving topical gel and subconjunctival lidocaine
Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc
Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.
Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment
Acuvail: Anti-inflammatory drop given after treatment
Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
134003|NCT01640171|P1|Participant Flow|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel
Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.
Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment
Acuvail: Anti-inflammatory drop given after treatment
Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion
Fellow eye Same as above plus Xylocaine 2% SC"
134004|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel
Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.
Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals
Acuvail: Anti-inflammatory drop given after treatment
Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion
Fellow eye:
Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
134005|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel
Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.
Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals
Acuvail: Anti-inflammatory drop given after treatment
Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion
Fellow eye:
Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
134006|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel
Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.
Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals
Acuvail: Anti-inflammatory drop given after treatment
Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion
Fellow eye:
Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
134007|NCT01640171|E2|Reported Event|Subconjunctival Anesthesia|"Eye receiving topical gel and subconjunctival lidocaine
Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc
Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.
Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment
Acuvail: Anti-inflammatory drop given after treatment
Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
134008|NCT01640171|E1|Reported Event|Topical Anesthesia|"Eye receiving only topical gel
Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.
Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment
Acuvail: Anti-inflammatory drop given after treatment
Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
134009|NCT01640054|B1|Baseline|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
134010|NCT01640054|P1|Participant Flow|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
134011|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
134012|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
134013|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
134014|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
134015|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
134016|NCT01640054|E1|Reported Event|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
134017|NCT01639833|B3|Baseline|Total|Total of all reporting groups
134030|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
134031|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
134032|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
134033|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
134034|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
134035|NCT01639755|E1|Reported Event|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
134036|NCT01639742|B1|Baseline|All Participants|All participants who had new texture round breast implants surgically implanted.
134037|NCT01639742|P1|Participant Flow|All Participants|All participants who had new texture round breast implants surgically implanted.
134038|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
134039|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
134040|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
134041|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
134042|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
134043|NCT01639742|E1|Reported Event|All Participants|All participants who had new texture round breast implants surgically implanted.
134044|NCT01639729|B1|Baseline|Treatment A, Followed by Treatment B, C and D in Random Order|Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) Sequence 1: A, B, C, D Sequence 2: A, B, D, C Sequence 3: A, C, B, D Sequence 4: A, C, D, B Sequence 5: A, D, B, C Sequence 6: A, D, C, B A 48-hour washout period separated each treatment period. The washout began with the start of dosing.
134045|NCT01639729|P6|Participant Flow|Sequence 6: Treatments A, D, C, B|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)
A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
134046|NCT01639729|P5|Participant Flow|Sequence Five: Treatments A, D, B, C|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)
A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
134047|NCT01639729|P4|Participant Flow|Sequence 4: Treatment A, C, D, B|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)
A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
134048|NCT01639729|P3|Participant Flow|Sequence 3: Treatment A, C, B, D|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)
A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
134049|NCT01639729|P2|Participant Flow|Sequence 2: A, B, D, C|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)
A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
134050|NCT01639729|P1|Participant Flow|Sequence 1: Treatment A, B, C, D|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)
A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
134051|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134052|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134053|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134054|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV
PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134055|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134056|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134057|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134108|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.
134058|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV
PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134110|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed for CT perfusion parameters, 47 were well differentiated according to WHO classification.
134059|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134060|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134061|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134062|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV
PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134063|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134064|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134065|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal
PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134066|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV
PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
134067|NCT01639729|E4|Reported Event|Sufentanil NanoTab Oral|Sufentanil : 15 mcg oral
134068|NCT01639729|E3|Reported Event|Sufentanil NanoTab Sublingual|Sufentanil : 15 mcg sublingaul
134069|NCT01639729|E2|Reported Event|Sufentanil NanoTab Buccal|Sufentanil : 15 mcg buccal
134070|NCT01639729|E1|Reported Event|Sufentanil IV|Sufentanil : 15 mcg IV
134071|NCT01639703|B1|Baseline|All Included Patients|All patients included in the study.
134072|NCT01639703|P1|Participant Flow|CT Perfusion|Xenetix-CT perfusion imaging: Injection of 50 ml of Xenetix
134073|NCT01639703|O4|Outcome|CD31 >50%|Quantification of CD31 labelling greater than 50%
134074|NCT01639703|O3|Outcome|CD31 10-50%|Quantification of CD31 labelling from 10 to 50%
134075|NCT01639703|O2|Outcome|CD31 1-10%|Quantification of CD31 labelling from 1 to 10%
134076|NCT01639703|O1|Outcome|CD31 0%|Absence of CD31 labelling
134077|NCT01639703|O4|Outcome|Glutamine Synthetase >50%|Quantification of glutamine synthetase labelling greater than 50%
134078|NCT01639703|O3|Outcome|Glutamine Synthetase 10-50%|Quantification of glutamine synthetase labelling from 10 to 50%
134079|NCT01639703|O2|Outcome|Glutamine Synthetase 1-10%|Quantification of glutamine synthetase labelling from 1 to 10%
134080|NCT01639703|O1|Outcome|Glutamine Synthetase 0%|Absence of glutamine synthetase labelling
134081|NCT01639703|O4|Outcome|CD31 >50%|Quantification of CD31 labelling greater than 50%
134082|NCT01639703|O3|Outcome|CD31 10-50%|Quantification of CD31 labelling from 10 to 50%
134083|NCT01639703|O2|Outcome|CD31 1-10%|Quantification of CD31 labelling from 1 to 10%
134084|NCT01639703|O1|Outcome|CD31 0%|Absence of glutamine synthetase labelling
134085|NCT01639703|O4|Outcome|Glutamine Synthetase >50%|Quantification of glutamine synthetase labelling greater than 50%
134086|NCT01639703|O3|Outcome|Glutamine Synthetase 10-50%|Quantification of glutamine synthetase labelling from 10 to 50%
134087|NCT01639703|O2|Outcome|Glutamine Synthetase 1-10%|Quantification of glutamine synthetase labelling from 1 to 10%
134088|NCT01639703|O1|Outcome|Glutamine Synthetase 0%|Absence of glutamine synthetase labelling
134089|NCT01639703|O4|Outcome|CD31 >50%|Quantification of CD31 labelling greater than 50%
134090|NCT01639703|O3|Outcome|CD31 10-50%|Quantification of CD31 labelling from 10 to 50%
134091|NCT01639703|O2|Outcome|CD31 1-10%|Quantification of CD31 labelling from 1 to 10%
134092|NCT01639703|O1|Outcome|CD31 0%|Absence of CD31 labelling
134093|NCT01639703|O4|Outcome|Glutamine Synthetase >50%|Quantification of glutamine synthetase labelling greater than 50%
134094|NCT01639703|O3|Outcome|Glutamine Synthetase 10-50%|Quantification of glutamine synthetase labelling from 10 to 50%
134095|NCT01639703|O2|Outcome|Glutamine Synthetase 1-10%|Quantification of glutamine synthetase labelling from 1 to 10%
134096|NCT01639703|O1|Outcome|Glutamine Synthetase 0%|Absence of glutamine synthetase labelling
134097|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
134098|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.
134099|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
134100|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.
134101|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
134102|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.
134103|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
134104|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification
134105|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
134106|NCT01639703|O1|Outcome|Well Differentiated Lesions|Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.
134107|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
134109|NCT01639703|O2|Outcome|Moderately/Poorly Differentiated Lesions|Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.
134111|NCT01639703|E1|Reported Event|Safety Set|All included patients receiving at least one injection of Xenetix, regardless of the quantity. This set was used for safety analyses.
134112|NCT01639560|B3|Baseline|Total|Total of all reporting groups
134113|NCT01639560|B2|Baseline|Placebo|"1 placebo tablet twice a day for 12 weeks
Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
134114|NCT01639560|B1|Baseline|Varenicline|"1 mg of varenicline twice per day for 12 weeks.
Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
134115|NCT01639560|P2|Participant Flow|Placebo|"1 placebo tablet twice a day for 12 weeks
Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
134116|NCT01639560|P1|Participant Flow|Varenicline|"1 mg of varenicline twice per day for 12 weeks.
Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
134117|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks
Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
134118|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.
Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
134119|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks
Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
134120|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.
Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
134121|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks
Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
134122|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.
Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
134123|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks
Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
134124|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.
Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
134125|NCT01639560|E2|Reported Event|Placebo|"1 placebo tablet twice a day for 12 weeks
Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
134126|NCT01639560|E1|Reported Event|Varenicline|"1 mg of varenicline twice per day for 12 weeks.
Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
134127|NCT01639469|B3|Baseline|Total|Total of all reporting groups
134128|NCT01639469|B2|Baseline|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone
Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
134129|NCT01639469|B1|Baseline|Structured Exercise|"Structured exercise instruction by smartphone
Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
134130|NCT01639469|P2|Participant Flow|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone
Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
134131|NCT01639469|P1|Participant Flow|Structured Exercise|"Structured exercise instruction by smartphone
Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
134132|NCT01639469|O2|Outcome|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone
Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
134133|NCT01639469|O1|Outcome|Structured Exercise|"Structured exercise instruction by smartphone
Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
134134|NCT01639469|E2|Reported Event|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone
Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
134135|NCT01639469|E1|Reported Event|Structured Exercise|"Structured exercise instruction by smartphone
Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
134136|NCT01639443|B3|Baseline|Total|Total of all reporting groups
134137|NCT01639443|B2|Baseline|Control|Patients who are scheduled routinely
134138|NCT01639443|B1|Baseline|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.
Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
134139|NCT01639443|P2|Participant Flow|Control|Patients who are scheduled routinely
134140|NCT01639443|P1|Participant Flow|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.
Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
134141|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
134142|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.
Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
134143|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
134173|NCT01639222|E1|Reported Event|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
145166|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
134174|NCT01639157|B1|Baseline|All Study Participants|Subjects were maintained on oral buspirone (10 mg administered 3 times daily) or placebo for 6 days each during the study in random order.
134175|NCT01639157|P2|Participant Flow|Placebo Then Buspirone|Subjects were maintained on placebo daily for 6 days, then they were crossed over to 30 mg buspirone daily for 6 days.
134144|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.
Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
134145|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
134146|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.
Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
134147|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
134148|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.
Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
134149|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
134150|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.
Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
134151|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
134152|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.
Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
134153|NCT01639443|E2|Reported Event|Control|Patients who are scheduled routinely
134154|NCT01639443|E1|Reported Event|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.
Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
134155|NCT01639352|B1|Baseline|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
134156|NCT01639352|P1|Participant Flow|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
134157|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
134158|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
134159|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
134160|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
134161|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
134162|NCT01639352|O1|Outcome|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
134163|NCT01639352|E1|Reported Event|SOM230|"60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days."
134164|NCT01639222|B1|Baseline|Calcium 500 mg and Vitamin D3 800 IU|"Period 1: Low calcium meals for up to 3 days.
Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals."
134165|NCT01639222|P1|Participant Flow|Calcium 500 mg and Vitamin D3 800 IU|"Period 1: Low calcium meals for up to 3 days.
Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals."
134166|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
134167|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
134168|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
134169|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
134170|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
134171|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
134172|NCT01639222|E2|Reported Event|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
134176|NCT01639157|P1|Participant Flow|Buspirone Then Placebo|Subjects were maintained on 30 mg buspirone daily for 6 days, then they were crossed over to placebo daily for 6 days.
134177|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134178|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134179|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134180|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134181|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134182|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134183|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134184|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134185|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134186|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134187|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134188|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134189|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134190|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134191|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134192|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134193|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134194|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134195|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134196|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134197|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134198|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134199|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134200|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134201|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134202|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134203|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134204|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134205|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134206|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134207|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134208|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134209|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134210|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134211|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134212|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134213|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134214|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134215|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134216|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134217|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134218|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134219|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134220|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134221|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134222|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134223|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134224|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134225|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134226|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134227|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134228|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134229|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
134230|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
134231|NCT01639157|E2|Reported Event|Placebo|"Subjects will be maintained on placebo.
Buspirone: Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order.These subjects will be the same as those who are maintained on buspirone (i.e., the study uses a within-subjects design)."
134331|NCT01638000|B1|Baseline|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134232|NCT01639157|E1|Reported Event|Buspirone|"Subjects will be maintained on buspirone.
Buspirone: Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order. These subjects will be the same as those who are maintained on placebo (i.e., the study uses a within-subjects design)."
134233|NCT01639144|B3|Baseline|Total|Total of all reporting groups
134235|NCT01639144|B1|Baseline|Receiving PRP and PPP.|"Administration of PRP and PPP to surgical site.
PRP and PPP: Autogenous PRP and PPP"
134236|NCT01639144|P2|Participant Flow|Control|Group not receiving autogenous PRP and PPP.
134237|NCT01639144|P1|Participant Flow|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
134238|NCT01639144|O2|Outcome|Control|Group not receiving autogenous PRP and PPP.
134239|NCT01639144|O1|Outcome|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
134240|NCT01639144|E2|Reported Event|Control|Group not receiving autogenous PRP and PPP.
134241|NCT01639144|E1|Reported Event|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
134242|NCT01639001|B3|Baseline|Total|Total of all reporting groups
134243|NCT01639001|B2|Baseline|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134244|NCT01639001|B1|Baseline|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134245|NCT01639001|P2|Participant Flow|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134246|NCT01639001|P1|Participant Flow|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134247|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134248|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134249|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134250|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134251|NCT01639001|O2|Outcome|Participants With Negative ALK FISH Status|Participants in the Molecular Profiling Evaluable population that had negative ALK FISH results.
134252|NCT01639001|O1|Outcome|Participants With Positive ALK FISH Status|Participants in the Molecular Profiling Evaluable population that had positive ALK FISH results.
134253|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134254|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134268|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
135608|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
134255|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134256|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134257|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134258|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134259|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134260|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134261|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134262|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134263|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134264|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134265|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134266|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134267|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134332|NCT01638000|P2|Participant Flow|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134269|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134270|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134271|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134272|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134273|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134274|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134275|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134276|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134277|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134278|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134279|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134280|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134298|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
134299|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
134300|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
134281|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134282|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134283|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134284|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134285|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134286|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134287|NCT01639001|E2|Reported Event|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
134288|NCT01639001|E1|Reported Event|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
134289|NCT01638559|B1|Baseline|Participants That Initiated Withdrawal|Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
134290|NCT01638559|P1|Participant Flow|Participants That Initiated Withdrawal|Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
134291|NCT01638559|O1|Outcome|Participants That Initiated Withdrawal|Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
134292|NCT01638559|E1|Reported Event|All Screened Participants|All participants that were screened for the study.
134293|NCT01638507|B1|Baseline|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
134294|NCT01638507|P1|Participant Flow|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
134295|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
134296|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
134297|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
145167|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
134301|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
134302|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
134303|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
134304|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
134305|NCT01638507|E1|Reported Event|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
134306|NCT01638468|B1|Baseline|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134307|NCT01638468|P1|Participant Flow|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134308|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134309|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134310|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134311|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134312|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134313|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134314|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134315|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134316|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134317|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134318|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134319|NCT01638468|E1|Reported Event|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System
AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
134320|NCT01638312|B3|Baseline|Total|Total of all reporting groups
134321|NCT01638312|B2|Baseline|"Healthy Controls"|The people didn't have infected HIV
134322|NCT01638312|B1|Baseline|"HIV Infected Patients"|The people had infected HIV
134323|NCT01638312|P2|Participant Flow|"Healthy Controls"|The people didn't have infected HIV
134324|NCT01638312|P1|Participant Flow|"HIV Infected Patients"|The people had infected HIV
134325|NCT01638312|O2|Outcome|"Healthy Controls"|"Healthy people
Graphical analysis of healthy people 1.7 of 30 healthy people were positive in waveform, and 23 were negative, the negative predictive value was 76.67%.
2.Healthy people was subjective judgments of participants, no other test as proof.
3.Graphical analysis of HIV-infected subjects"
134326|NCT01638312|O1|Outcome|"HIV Infected Patients"|20 There are six medication negative response, referring to a recent comparison of the value of the blood virus date, there are three items detected waveform error, the remaining non-medication of 14, there are two detection waveform is negative; positive predictive value = 60%
134327|NCT01638312|E2|Reported Event|"Healthy Controls"|Serious and Other (Not Including Serious) Adverse Events were not collected
134328|NCT01638312|E1|Reported Event|"HIV Infected Patients"|Serious and Other (Not Including Serious) Adverse Events were not collected
134329|NCT01638000|B3|Baseline|Total|Total of all reporting groups
134330|NCT01638000|B2|Baseline|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134333|NCT01638000|P1|Participant Flow|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134334|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134335|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134336|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134337|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134338|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134339|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134340|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134341|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134342|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134343|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134344|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134345|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134346|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134347|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134348|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134349|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134350|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134351|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134352|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134353|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134354|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134355|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134356|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134357|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134358|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134359|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134360|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134361|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134362|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134363|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134364|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134365|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134366|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134367|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134368|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134369|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134370|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134371|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134372|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134373|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134374|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134375|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134376|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134377|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134378|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134379|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134380|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134381|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134382|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134383|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134384|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134385|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134386|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134387|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134388|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134389|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134390|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134391|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134392|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134393|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134394|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134395|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134396|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134397|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134398|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134399|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134400|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134401|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134402|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134403|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134404|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134405|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134406|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134407|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134408|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134409|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134410|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134411|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134412|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134413|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134414|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134415|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134416|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134417|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134418|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134419|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134420|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134421|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134422|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134423|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134424|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134425|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134426|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134427|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134428|NCT01638000|E2|Reported Event|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
134429|NCT01638000|E1|Reported Event|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
134430|NCT01637961|B1|Baseline|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
134431|NCT01637961|P1|Participant Flow|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
134432|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
134433|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
134434|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
134435|NCT01637961|E1|Reported Event|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
134436|NCT01637935|B3|Baseline|Total|Total of all reporting groups
134437|NCT01637935|B2|Baseline|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
134438|NCT01637935|B1|Baseline|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
134439|NCT01637935|P2|Participant Flow|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
134440|NCT01637935|P1|Participant Flow|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
145168|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
134454|NCT01637922|B2|Baseline|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134455|NCT01637922|B1|Baseline|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134456|NCT01637922|P2|Participant Flow|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9."
134457|NCT01637922|P1|Participant Flow|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.
BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9."
134458|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134459|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134460|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134461|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134462|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134463|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134464|NCT01637922|O2|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134465|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134466|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134467|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134468|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134469|NCT01637922|O2|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134470|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134471|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134472|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134473|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134474|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134475|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134476|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134477|NCT01637922|E2|Reported Event|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134478|NCT01637922|E1|Reported Event|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.
BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
134479|NCT01637584|B3|Baseline|Total|Total of all reporting groups
134480|NCT01637584|B2|Baseline|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication
Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
134481|NCT01637584|B1|Baseline|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.
Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
134522|NCT01637272|O3|Outcome|SOM230 - 8 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
134827|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134482|NCT01637584|P2|Participant Flow|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication
Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
135609|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
134483|NCT01637584|P1|Participant Flow|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.
Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
134484|NCT01637584|O2|Outcome|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication
Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
134485|NCT01637584|O1|Outcome|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.
Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
134486|NCT01637584|O1|Outcome|Prazosin -Placebo|Difference in relative brain glucose metabolism between states and pre-to-post treatment for participants randomized to prazosin after adjusting for non-significant changes in the placebo group.
134487|NCT01637584|E2|Reported Event|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication
Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
134488|NCT01637584|E1|Reported Event|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.
Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
134489|NCT01637272|B1|Baseline|SOM230|Subjects with dumping syndrome treated with pasireotide
134490|NCT01637272|P1|Participant Flow|SOM230|Subjects with dumping syndrome treated with pasireotide
134491|NCT01637272|O4|Outcome|SOM LAR 40mg|Subjects with dumping syndrome treated with pasireotide LAR 40mg
134492|NCT01637272|O3|Outcome|SOM LAR 30mg|Subjects with dumping syndrome treated with pasireotide LAR 30mg
134493|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
134494|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
134495|NCT01637272|O5|Outcome|SOM LAR 60mg|Subjects with dumping syndrome treated with pasireotide LAR 60mg
134496|NCT01637272|O4|Outcome|SOM LAR 40mg|Subjects with dumping syndrome treated with pasireotide LAR 40mg
134497|NCT01637272|O3|Outcome|SOM LAR 30mg|Subjects with dumping syndrome treated with pasireotide LAR 30mg
134498|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
134499|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
134500|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
134501|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
134502|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
134503|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
134504|NCT01637272|O4|Outcome|SOM sc 200 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
134505|NCT01637272|O3|Outcome|SOM sc 150 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
134506|NCT01637272|O2|Outcome|SOM sc 100 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
134507|NCT01637272|O1|Outcome|SOM sc 50 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
134508|NCT01637272|O4|Outcome|SOM sc 200 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
134509|NCT01637272|O3|Outcome|SOM sc 150 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
134510|NCT01637272|O2|Outcome|SOM sc 100 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
134511|NCT01637272|O1|Outcome|SOM sc 50 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
134512|NCT01637272|O4|Outcome|SOM sc 200 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
134513|NCT01637272|O3|Outcome|SOM sc 150 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
134514|NCT01637272|O2|Outcome|SOM sc 100 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
134515|NCT01637272|O1|Outcome|SOM sc 50 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
134516|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
134517|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
134518|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
134519|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
134520|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
134521|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
134523|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
134524|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
136589|NCT01626820|B3|Baseline|Total|Total of all reporting groups
134525|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
134526|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
134527|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
134528|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
134529|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
134530|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
134531|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
134532|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
134533|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
134534|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
134535|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
134536|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
134537|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
134538|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
134539|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
134540|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
134541|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
134542|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
134543|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
134544|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
134545|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
134546|NCT01637272|O2|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
134547|NCT01637272|O1|Outcome|SOM230- 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M)followed by pasireotide LAR (3M) for a total of 6 months
134548|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
134549|NCT01637272|E2|Reported Event|LAR Phase|LAR phase was made up of subjects with dumping syndrome who completed the s.c. phase, entered the LAR phase and were treated with pasireotide LAR
134550|NCT01637272|E1|Reported Event|s.c. Phase|s.c. phase was made up of subjects with dumping syndrome who entered the study and were treated with pasireotide s.c.
134551|NCT01637246|B1|Baseline|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
134552|NCT01637246|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
134553|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
134554|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
134555|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
134556|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
134557|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
134558|NCT01637246|E1|Reported Event|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
134559|NCT01637090|B1|Baseline|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.
This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.
Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
134578|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
134579|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
134700|NCT01636661|O1|Outcome|Transcranial Direct Current Stimulation|"Receiving active tDCS
tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
134580|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
134560|NCT01637090|P1|Participant Flow|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.
This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.
Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
134561|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.
This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.
Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
134562|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.
This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.
Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
134563|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.
This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.
Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
134564|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.
This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.
Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
134565|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.
This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.
Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
134566|NCT01637090|E1|Reported Event|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.
This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.
Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
134567|NCT01636986|B3|Baseline|Total|Total of all reporting groups
134568|NCT01636986|B2|Baseline|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
134569|NCT01636986|B1|Baseline|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
134570|NCT01636986|P2|Participant Flow|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
134571|NCT01636986|P1|Participant Flow|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
134572|NCT01636986|O2|Outcome|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
134573|NCT01636986|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
134574|NCT01636986|E2|Reported Event|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
134575|NCT01636986|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
134576|NCT01636960|B1|Baseline|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
134577|NCT01636960|P1|Participant Flow|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
134581|NCT01636960|E1|Reported Event|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
134582|NCT01636947|B3|Baseline|Total|Total of all reporting groups
134583|NCT01636947|B2|Baseline|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
134584|NCT01636947|B1|Baseline|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
134585|NCT01636947|P2|Participant Flow|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
134586|NCT01636947|P1|Participant Flow|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
134587|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
134588|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
134589|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
134590|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
134591|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
134592|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
134593|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
134594|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
134595|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
134596|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
134597|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
134598|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
134599|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
134600|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
134601|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
134602|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
134603|NCT01636947|E2|Reported Event|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
134698|NCT01636661|P1|Participant Flow|Transcranial Direct Current Stimulation|"Receiving active tDCS
tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
145169|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
134701|NCT01636661|O2|Outcome|Sham tDCS|"tDCS equipment set to placebo setting.
tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
136680|NCT01626118|P4|Participant Flow|Placebo|Placebo Group
134604|NCT01636947|E1|Reported Event|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
134605|NCT01636778|B1|Baseline|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134606|NCT01636778|P3|Participant Flow|Eltrombopag + Antiviral Therapy: Follow-up Period After Part|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134607|NCT01636778|P2|Participant Flow|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134608|NCT01636778|P1|Participant Flow|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134609|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134610|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134611|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134612|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134613|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134614|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134615|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134616|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134617|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134618|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
145170|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
134619|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134620|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134621|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134622|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134623|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134624|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134625|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134626|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134627|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134628|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134629|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134630|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134631|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134632|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134633|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
135454|NCT01632995|O1|Outcome|Participants Assessed for Participation|All participants who were assessed for study participation
134634|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134635|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134636|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134637|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134638|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134639|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134640|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134641|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134642|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134643|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134644|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134645|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134646|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134647|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134648|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134649|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134650|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134651|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134652|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134653|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134654|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134655|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134656|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134657|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134658|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134659|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134660|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134661|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134662|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134663|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134664|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134699|NCT01636661|O2|Outcome|Sham tDCS|"tDCS equipment set to placebo setting.
tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
134665|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134666|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134667|NCT01636778|E3|Reported Event|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
134668|NCT01636778|E2|Reported Event|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
134669|NCT01636778|E1|Reported Event|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of &lt;80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was &lt;100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained &lt;100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts &gt;=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts &gt;=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
134670|NCT01636765|B1|Baseline|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
134671|NCT01636765|P1|Participant Flow|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
134672|NCT01636765|O1|Outcome|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
134673|NCT01636765|O1|Outcome|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
134674|NCT01636765|E1|Reported Event|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
134675|NCT01636713|B4|Baseline|Total|Total of all reporting groups
134676|NCT01636713|B3|Baseline|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
134677|NCT01636713|B2|Baseline|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
134678|NCT01636713|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
134679|NCT01636713|P3|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
134680|NCT01636713|P2|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
134681|NCT01636713|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
134682|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
134683|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
134684|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
134685|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
134686|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
134687|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
134688|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
134689|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
134690|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
134691|NCT01636713|E3|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
134692|NCT01636713|E2|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
134693|NCT01636713|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
134694|NCT01636661|B3|Baseline|Total|Total of all reporting groups
134695|NCT01636661|B2|Baseline|Sham tDCS|"tDCS equipment set to placebo setting.
tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
134696|NCT01636661|B1|Baseline|Transcranial Direct Current Stimulation|"Receiving active tDCS
tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
134697|NCT01636661|P2|Participant Flow|Sham tDCS|"tDCS equipment set to placebo setting.
tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
135455|NCT01632995|O1|Outcome|Participants Assessed for Participation|All participants who were assessed for study participation
134702|NCT01636661|O1|Outcome|Transcranial Direct Current Stimulation|"Receiving active tDCS
tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
134703|NCT01636661|E2|Reported Event|Sham tDCS|"tDCS equipment set to placebo setting.
tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
134704|NCT01636661|E1|Reported Event|Transcranial Direct Current Stimulation|"Receiving active tDCS
tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
134705|NCT01636466|B3|Baseline|Total|Total of all reporting groups
134706|NCT01636466|B2|Baseline|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
134707|NCT01636466|B1|Baseline|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
134708|NCT01636466|P2|Participant Flow|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
134709|NCT01636466|P1|Participant Flow|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
134710|NCT01636466|O2|Outcome|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
134711|NCT01636466|O1|Outcome|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
134712|NCT01636466|E2|Reported Event|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
134713|NCT01636466|E1|Reported Event|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
134714|NCT01636414|B4|Baseline|Total|Total of all reporting groups
134715|NCT01636414|B3|Baseline|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
134716|NCT01636414|B2|Baseline|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
134717|NCT01636414|B1|Baseline|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
134718|NCT01636414|P3|Participant Flow|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
134719|NCT01636414|P2|Participant Flow|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
134720|NCT01636414|P1|Participant Flow|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
134721|NCT01636414|O3|Outcome|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
134722|NCT01636414|O2|Outcome|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
134723|NCT01636414|O1|Outcome|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
134724|NCT01636414|O3|Outcome|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
134725|NCT01636414|O2|Outcome|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
134726|NCT01636414|O1|Outcome|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
134727|NCT01636414|E3|Reported Event|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
134728|NCT01636414|E2|Reported Event|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
134729|NCT01636414|E1|Reported Event|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
134730|NCT01636362|B1|Baseline|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
134731|NCT01636362|P1|Participant Flow|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
134778|NCT01636076|B2|Baseline|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134779|NCT01636076|B1|Baseline|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134780|NCT01636076|P2|Participant Flow|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134732|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
134733|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
134734|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
134735|NCT01636362|E1|Reported Event|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
134736|NCT01636258|B3|Baseline|Total|Total of all reporting groups
134737|NCT01636258|B2|Baseline|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education
Exercise : Every week
Diet : Every other week
Culinary education : Every other week
Stress Management : Every other week"
134738|NCT01636258|B1|Baseline|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
134739|NCT01636258|P2|Participant Flow|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education
Exercise : Every week
Diet : Every other week
Culinary education : Every other week
Stress Management : Every other week"
134740|NCT01636258|P1|Participant Flow|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
134741|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education
Stress Management: Every other week
Diet: Every other week
Exercise: Every week
Culinary education: Every other week"
134742|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
134743|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education
Stress Management: Every other week
Diet: Every other week
Exercise: Every week
Culinary education: Every other week"
134744|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
134745|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education
Stress Management: Every other week
Diet: Every other week
Exercise: Every week
Culinary education: Every other week"
134746|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
134747|NCT01636258|O2|Outcome|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education
Exercise : Every week
Diet : Every other week
Culinary education : Every other week
Stress Management : Every other week"
134748|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
134749|NCT01636258|O2|Outcome|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education
Exercise : Every week
Diet : Every other week
Culinary education : Every other week
Stress Management : Every other week"
134750|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
134751|NCT01636258|E2|Reported Event|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education
Exercise : Every week
Diet : Every other week
Culinary education : Every other week
Stress Management : Every other week"
134752|NCT01636258|E1|Reported Event|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
134753|NCT01636206|B3|Baseline|Total|Total of all reporting groups
134754|NCT01636206|B2|Baseline|Lifitegrast|
134755|NCT01636206|B1|Baseline|Placebo|
134756|NCT01636206|P2|Participant Flow|Lifitegrast|
134757|NCT01636206|P1|Participant Flow|Placebo|
134758|NCT01636206|O2|Outcome|Lifitegrast|
134759|NCT01636206|O1|Outcome|Placebo|
134760|NCT01636206|E2|Reported Event|Lifitegrast|
134761|NCT01636206|E1|Reported Event|Placebo|
134762|NCT01636102|B3|Baseline|Total|Total of all reporting groups
134763|NCT01636102|B2|Baseline|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
134764|NCT01636102|B1|Baseline|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
134765|NCT01636102|P2|Participant Flow|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
134766|NCT01636102|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
134767|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
134768|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
134769|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
134770|NCT01636102|O1|Outcome|18 - 60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
134771|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
134772|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
134773|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
134774|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
134775|NCT01636102|E2|Reported Event|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
134776|NCT01636102|E1|Reported Event|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
134777|NCT01636076|B3|Baseline|Total|Total of all reporting groups
134781|NCT01636076|P1|Participant Flow|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134782|NCT01636076|O2|Outcome|QMF149 Analyte QAB149|QMF149 analyte QAB149 ( indacaterol acetate)
134783|NCT01636076|O1|Outcome|QMF149 Analyte Mometasone Furoate|QMF149 Mometasone furoate analyte from mixture
134784|NCT01636076|O2|Outcome|QMF149 Analyte: Indacaterol Acetate|QAB149: indacaterol acetate as a component of QMF149F
134785|NCT01636076|O1|Outcome|QMF 149 Anaylyte: Mometasone Furorate|Mometasone furoate as a component of QMF149F
134786|NCT01636076|O2|Outcome|QMF149 Analyte: Indacaterol Acetate|QAB149: indacaterol acetate as a component of QMF149F
134787|NCT01636076|O1|Outcome|QMF149 Analyte: Mometasone Furoate|Mometasone furoate as part of QMF149F
134788|NCT01636076|O2|Outcome|QMF149 (Analyte Indacaterol Acetate)|Assay Analyte: QAB149 (Indacaterol acetate), component of QMF 149 mixture
134789|NCT01636076|O1|Outcome|QMF149 (Analyte Mometasone Furoate)|Assay Analyte: MOMETASONE FUROATE, component of QMF 149 mixture
134790|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134791|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134792|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134793|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134794|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134795|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134796|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134797|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134798|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134799|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134800|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134801|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134802|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134803|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134804|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134805|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134806|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134807|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134808|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134809|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134810|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134811|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134812|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134813|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134814|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134815|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134816|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134817|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134818|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134819|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134820|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134821|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134822|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134823|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134824|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134825|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134826|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
135478|NCT01632735|B3|Baseline|Total|Total of all reporting groups
134828|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134829|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134830|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134831|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134832|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134833|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134834|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134835|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134836|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
134837|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134838|NCT01636076|E2|Reported Event|SALM/FLUT|SALM/FLUT
134839|NCT01636076|E1|Reported Event|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
134840|NCT01636063|B3|Baseline|Total|Total of all reporting groups
134841|NCT01636063|B2|Baseline|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.
Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
134842|NCT01636063|B1|Baseline|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion
Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
134843|NCT01636063|P2|Participant Flow|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.
Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
134844|NCT01636063|P1|Participant Flow|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion
Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
134845|NCT01636063|O2|Outcome|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.
Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
134846|NCT01636063|O1|Outcome|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion
Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
134847|NCT01636063|E2|Reported Event|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.
Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
134848|NCT01636063|E1|Reported Event|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion
Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
134849|NCT01635933|B3|Baseline|Total|Total of all reporting groups
134850|NCT01635933|B2|Baseline|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134851|NCT01635933|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134852|NCT01635933|P2|Participant Flow|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134853|NCT01635933|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134854|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134855|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134856|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134857|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134858|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134859|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134860|NCT01635933|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134861|NCT01635933|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
134862|NCT01635920|B3|Baseline|Total|Total of all reporting groups
134863|NCT01635920|B2|Baseline|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
135479|NCT01632735|B2|Baseline|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
135325|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
134864|NCT01635920|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
134865|NCT01635920|P2|Participant Flow|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
134866|NCT01635920|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
134867|NCT01635920|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
134868|NCT01635920|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with print worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
134869|NCT01635920|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
134870|NCT01635920|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
134871|NCT01635920|E2|Reported Event|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
134872|NCT01635920|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
134873|NCT01635881|B1|Baseline|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
134874|NCT01635881|P1|Participant Flow|Emerge|Single arm with investigational Emerge™ 1.20 mm percutaneous transluminal coronary angioplasty (PTCA) Dilatation Catheter
134875|NCT01635881|O1|Outcome|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
134876|NCT01635881|O1|Outcome|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
134877|NCT01635881|E1|Reported Event|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
134878|NCT01635855|B1|Baseline|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
134879|NCT01635855|P1|Participant Flow|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
134880|NCT01635855|O1|Outcome|Belotero|Belotero®: Hyaluronic acid dermal filler
134881|NCT01635855|E1|Reported Event|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
134882|NCT01635504|B1|Baseline|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
134883|NCT01635504|P1|Participant Flow|Botulinum Toxin A|Botulinum toxin A 50 units per side of the posterior cheek enlargement, injected into the masseter muscle and parotid gland (10 units into 5 points of the posterior cheek enlargement per side, giving a total of 100 units per patient)
134884|NCT01635504|O1|Outcome|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
134885|NCT01635504|O1|Outcome|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
134886|NCT01635504|E1|Reported Event|HIV Posterior Cheek Enlargement Group|Injected with botulinum toxin A
134887|NCT01635439|B3|Baseline|Total|Total of all reporting groups
134888|NCT01635439|B2|Baseline|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
134889|NCT01635439|B1|Baseline|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
134890|NCT01635439|P2|Participant Flow|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
134891|NCT01635439|P1|Participant Flow|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
134892|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
134893|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
134894|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
134895|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
134896|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
134897|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
134898|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
134899|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
134900|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
134901|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
134902|NCT01635439|E2|Reported Event|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
134903|NCT01635439|E1|Reported Event|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
134904|NCT01635244|B4|Baseline|Total|Total of all reporting groups
134905|NCT01635244|B3|Baseline|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134906|NCT01635244|B2|Baseline|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134907|NCT01635244|B1|Baseline|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134908|NCT01635244|P3|Participant Flow|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134909|NCT01635244|P2|Participant Flow|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134910|NCT01635244|P1|Participant Flow|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134911|NCT01635244|O3|Outcome|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134912|NCT01635244|O2|Outcome|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134913|NCT01635244|O1|Outcome|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134914|NCT01635244|E3|Reported Event|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134915|NCT01635244|E2|Reported Event|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134916|NCT01635244|E1|Reported Event|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
134917|NCT01635218|B4|Baseline|Total|Total of all reporting groups
134918|NCT01635218|B3|Baseline|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
134919|NCT01635218|B2|Baseline|Fluoxetine|"Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
134920|NCT01635218|B1|Baseline|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
134921|NCT01635218|P3|Participant Flow|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
134922|NCT01635218|P2|Participant Flow|Fluoxetine|"Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
134923|NCT01635218|P1|Participant Flow|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
134924|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
134925|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
134926|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
134927|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
134928|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
134929|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
134930|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
134931|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
134932|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
134933|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
134934|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
134935|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
134936|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
134937|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
134938|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
134939|NCT01635218|E3|Reported Event|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
134940|NCT01635218|E2|Reported Event|Fluoxetine|"Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded could be repeated at week 4."
134941|NCT01635218|E1|Reported Event|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
134942|NCT01635062|B3|Baseline|Total|Total of all reporting groups
134943|NCT01635062|B2|Baseline|Placebo|"Subjects will receive placebo for 3 weeks.
Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
134944|NCT01635062|B1|Baseline|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.
Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
134945|NCT01635062|P2|Participant Flow|Placebo|"Subjects will receive placebo for 3 weeks.
Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
134946|NCT01635062|P1|Participant Flow|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.
Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
134947|NCT01635062|O2|Outcome|Placebo|Subjects have their urine protein assessed at baseline while sodium sodium loaded and again following 3 weeks of randomization to calcitriol (up to 0.75 mcg daily) or placebo.
134948|NCT01635062|O1|Outcome|Calcitriol|Subjects have their urine protein assessed at baseline while sodium sodium loaded and again following 3 weeks of randomization to calcitriol (up to 0.75 mcg daily) or placebo.
134949|NCT01635062|O2|Outcome|Placebo|Subjects have their renal plasma flow assessed at baseline while sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat renal plasma flow assessments again while sodium loaded.
134950|NCT01635062|O1|Outcome|Calcitriol|Subjects have their renal plasma flow assessed at baseline while sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat renal plasma flow assessments again while sodium loaded.
134951|NCT01635062|O2|Outcome|Placebo|Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
134952|NCT01635062|O1|Outcome|Calcitriol|Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
134953|NCT01635062|E2|Reported Event|Placebo|"Subjects will receive placebo for 3 weeks.
Placebo: Subjects will receive placebo for 3 weeks."
134954|NCT01635062|E1|Reported Event|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.
Calcitriol: Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks."
134955|NCT01634854|B3|Baseline|Total|Total of all reporting groups
134956|NCT01634854|B2|Baseline|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous"
134957|NCT01634854|B1|Baseline|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
134958|NCT01634854|P2|Participant Flow|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous"
134959|NCT01634854|P1|Participant Flow|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
134960|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous"
134961|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
134962|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous"
134963|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
134964|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous"
134965|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
135142|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
134966|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous"
134967|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
134968|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous"
134969|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
134970|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous"
134971|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
134972|NCT01634854|O2|Outcome|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous"
134973|NCT01634854|O1|Outcome|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
134974|NCT01634854|E2|Reported Event|Intravenous Oxytocin|"2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous"
134975|NCT01634854|E1|Reported Event|Vaginal Misoprostol|"Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal"
134976|NCT01634659|B3|Baseline|Total|Total of all reporting groups
134977|NCT01634659|B2|Baseline|Narafilcon B, Then Delefilcon A|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
134978|NCT01634659|B1|Baseline|Delefilcon A, Then Narafilcon B|Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
134979|NCT01634659|P2|Participant Flow|Narafilcon B, Then Delefilcon A|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
134980|NCT01634659|P1|Participant Flow|Delefilcon A, Then Narafilcon B|Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
134981|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
134982|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
134983|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
134984|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
134985|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
134986|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
134987|NCT01634659|E2|Reported Event|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
134988|NCT01634659|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
134989|NCT01634620|B1|Baseline|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
134990|NCT01634620|P1|Participant Flow|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
134991|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
134992|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).
High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
134993|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).
Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
134994|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).
Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
134995|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).
High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
134996|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).
Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
134997|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).
Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
134998|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).
High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
134999|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).
Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
135000|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).
Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
135001|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
135002|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
135593|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
135003|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
135004|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
135005|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
135006|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
135007|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
135008|NCT01634620|E1|Reported Event|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
135009|NCT01634555|B1|Baseline|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+
Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)
Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle
Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle"
135010|NCT01634555|P1|Participant Flow|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+
Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered as an intravenous (IV) infusion on Day 1 of each 2-week cycle (except Cycle 1)
Irinotecan: 180 milligrams per square meter (mg/m²) administered IV on Day 1 of each 2-week cycle
Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each 2-week cycle"
135011|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)
Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)
Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
135012|NCT01634555|O1|Outcome|FOLFIRI (Cycle 1)|"Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)"
135013|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)
Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)
Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
135014|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)
Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)
Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
135015|NCT01634555|O1|Outcome|FOLFIRI (Cycle 1)|"Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)"
135016|NCT01634555|E1|Reported Event|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+
Ramucirumab (IMC-1121B): 8 mg/kg, administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)
Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle
Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle
5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle"
135017|NCT01634360|B3|Baseline|Total|Total of all reporting groups
135018|NCT01634360|B2|Baseline|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135019|NCT01634360|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135020|NCT01634360|P2|Participant Flow|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135021|NCT01634360|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135022|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135023|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135024|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135025|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135026|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135027|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135028|NCT01634360|E2|Reported Event|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135602|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135029|NCT01634360|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
135030|NCT01634256|B3|Baseline|Total|Total of all reporting groups
135031|NCT01634256|B2|Baseline|Placebo|
135032|NCT01634256|B1|Baseline|Fermented Curcuma|
135033|NCT01634256|P2|Participant Flow|Placebo|"Placebo(3times/day, 6capsules/day, 3g/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Fermented turmeric."
135034|NCT01634256|P1|Participant Flow|Fermented Turmeric|"Fermented turmeric(3times/day, 6capsules/day, 3g/day) for 12weeks
Fermented curcuma : Powdered Curcuma longa L., was produced through the fermentation of Aspergillus oryzae to 25 ˚ C for 36 hours."
135035|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
135036|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
135037|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
135038|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
135039|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
135040|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
135041|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
135042|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
135043|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
135044|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
135045|NCT01634256|E2|Reported Event|Placebo|Oral intake placebo(3.0g/day) for 12weeks
135046|NCT01634256|E1|Reported Event|Fermented Curcuma|Oral intake fermented curcuma (3.0g/day) for 12weeks.
135047|NCT01634243|B3|Baseline|Total|Total of all reporting groups
135048|NCT01634243|B2|Baseline|Advanced Parkinson's Disease|
135049|NCT01634243|B1|Baseline|Early-stage Parkinson's Disease|
135050|NCT01634243|P2|Participant Flow|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135051|NCT01634243|P1|Participant Flow|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135052|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135053|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135054|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135055|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135056|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135057|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135058|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135059|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135060|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135061|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135062|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135063|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135064|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135065|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135066|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135067|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135068|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135069|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135070|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135071|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135072|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
135073|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
135074|NCT01634243|E2|Reported Event|Advanced Parkinson's Disease|
135075|NCT01634243|E1|Reported Event|Early-stage Parkinson's Disease|
135076|NCT01634165|B1|Baseline|All Participants|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016, or 0.6 U/kg LY2963016, or 0.3 U/kg Lantus, or 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135077|NCT01634165|P4|Participant Flow|0.6 U/kg Lantus, 0.3 U/kg Lantus, 0.6 U/kg LY, 0.3 U/kg LY|Single subcutaneous dose of 0.6 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg Lantus during Period 2; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
135078|NCT01634165|P3|Participant Flow|0.3 U/kg Lantus, 0.3 U/kg LY, 0.6 U/kg Lantus, 0.6 U/kg LY|Single subcutaneous dose of 0.3 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.6 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
135079|NCT01634165|P2|Participant Flow|0.6 U/kg LY, 0.6 U/kg Lantus, 0.3 U/kg LY, 0.3 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg Lantus during Period 2; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
135080|NCT01634165|P1|Participant Flow|0.3 U/kg LY, 0.6 U/kg LY, 0.3 U/kg Lantus, 0.6 U/kg Lantus|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.3 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
135081|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135082|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135083|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135084|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135085|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135086|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135087|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135088|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135089|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135090|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135091|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135092|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135093|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135094|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135095|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135096|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135097|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135098|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135099|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135100|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135101|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135102|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135103|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135104|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135105|NCT01634165|E4|Reported Event|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135106|NCT01634165|E3|Reported Event|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135107|NCT01634165|E2|Reported Event|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135108|NCT01634165|E1|Reported Event|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
135109|NCT01634152|B4|Baseline|Total|Total of all reporting groups
135110|NCT01634152|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135111|NCT01634152|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135112|NCT01634152|B1|Baseline|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135113|NCT01634152|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135114|NCT01634152|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135115|NCT01634152|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135116|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135117|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135118|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135119|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135120|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135121|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135122|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135123|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135124|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135125|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135126|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135127|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135128|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135129|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135130|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135131|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135132|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135133|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135134|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135135|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135136|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135137|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135138|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135139|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135140|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135141|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135143|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135144|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135145|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135146|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135147|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135148|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135149|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135150|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135151|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135152|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135153|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135154|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135155|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135156|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135157|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135158|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135159|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135160|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135161|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135162|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135163|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135164|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135165|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135166|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135167|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135168|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135169|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135170|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135171|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135172|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135173|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135174|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135175|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135176|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135212|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135177|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135178|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135179|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135180|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135181|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135182|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135183|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135184|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135185|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135186|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135187|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135188|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135189|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135190|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135191|NCT01634152|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135192|NCT01634152|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135193|NCT01634152|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135194|NCT01634139|B4|Baseline|Total|Total of all reporting groups
135195|NCT01634139|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135196|NCT01634139|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135197|NCT01634139|B1|Baseline|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135198|NCT01634139|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135199|NCT01634139|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135200|NCT01634139|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135201|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135202|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135203|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135204|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135205|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135206|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135207|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135208|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135209|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135210|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135211|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135213|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135214|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135215|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135216|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135217|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135218|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135219|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135220|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135221|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135222|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135223|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135224|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135225|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135226|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135227|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135228|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135229|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135230|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135231|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135232|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135233|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135234|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135235|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135236|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135237|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135238|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135239|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135240|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135241|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135242|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135243|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135244|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135245|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135246|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135324|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135247|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135248|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135249|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135250|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135251|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135252|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135253|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135254|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135255|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135256|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135257|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135258|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135259|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135260|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135261|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135262|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135263|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135264|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135265|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135266|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135267|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135268|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135269|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135270|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135271|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135272|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135273|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135274|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135275|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135276|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135277|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135278|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135279|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135280|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135281|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135282|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135283|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135284|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135285|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135286|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135287|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135288|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135289|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135290|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135291|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135292|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135293|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135294|NCT01634139|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135295|NCT01634139|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135296|NCT01634139|E1|Reported Event|Placebo|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
135297|NCT01634113|B4|Baseline|Total|Total of all reporting groups
135298|NCT01634113|B3|Baseline|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135299|NCT01634113|B2|Baseline|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135300|NCT01634113|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135301|NCT01634113|P3|Participant Flow|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135302|NCT01634113|P2|Participant Flow|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135303|NCT01634113|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135304|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135305|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135306|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135307|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135308|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135309|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135310|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135311|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135312|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135313|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135314|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135315|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135316|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135317|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135318|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135319|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135320|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135321|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135322|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135323|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
145171|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
135326|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135327|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135328|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135329|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135330|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135331|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135332|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135333|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135334|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135335|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135336|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135337|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135338|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135339|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135340|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135341|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135342|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135343|NCT01634113|E3|Reported Event|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
135344|NCT01634113|E2|Reported Event|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
135345|NCT01634113|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
135346|NCT01634100|B1|Baseline|Study Overall|This was a randomised, 3-way crossover trial. 18 patients were randomised to one of six treatment sequences and treated. It was an open label trial in which each treatment period lasted 4 days with a washout period of at least 7 days between each.
135347|NCT01634100|P6|Participant Flow|Empa + Probenecid / Empa + Rifampicin / Empa Alone|"Patients were administered three treatments in the following order:
Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)
Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)
Empa Alone (A single dose of 10mg of empagliflozin (empa))"
135348|NCT01634100|P5|Participant Flow|Empa + Probenecid / Empa Alone / Empa + Rifampicin|"Patients were administered three treatments in the following order:
Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)
Empa Alone (A single dose of 10mg of empagliflozin (empa))
Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)"
135349|NCT01634100|P4|Participant Flow|Empa + Rifampicin / Empa + Probenecid / Empa Alone|"Patients were administered three treatments in the following order:
Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)
Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)
Empa Alone (A single dose of 10mg of empagliflozin (empa))"
135350|NCT01634100|P3|Participant Flow|Empa + Rifampicin / Empa Alone / Empa + Probenecid|"Patients were administered three treatments in the following order:
Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)
Empa Alone (A single dose of 10mg of empagliflozin (empa))
Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)"
135351|NCT01634100|P2|Participant Flow|Empa Alone / Empa + Probenecid / Empa + Rifampicin|"Patients were administered three treatments in the following order:
Empa Alone (A single dose of 10mg of empagliflozin (empa))
Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)
Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)"
135352|NCT01634100|P1|Participant Flow|Empa Alone / Empa + Rifampicin / Empa + Probenecid|"Patients were administered three treatments in the following order:
Empa Alone (A single dose of 10mg of empagliflozin (empa))
Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)
Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)"
135353|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
135354|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
135355|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
135356|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
135357|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
135359|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
135360|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
135361|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
135362|NCT01634100|E3|Reported Event|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
135363|NCT01634100|E2|Reported Event|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
135364|NCT01634100|E1|Reported Event|Empa Alone|A single dose of 10mg of empagliflozin (empa).
135365|NCT01633944|B3|Baseline|Total|Total of all reporting groups
135366|NCT01633944|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135367|NCT01633944|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135368|NCT01633944|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135369|NCT01633944|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135370|NCT01633944|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 75, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration phase
135371|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135372|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135373|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135374|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135375|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135376|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135377|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135378|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135379|NCT01633944|O1|Outcome|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 75, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration phase
135380|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135381|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135382|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135383|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135384|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135385|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135386|NCT01633944|E3|Reported Event|DB Placebo Film|Placebo buccal film, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135387|NCT01633944|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
135388|NCT01633944|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 75, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration treatment phase
135389|NCT01633892|B1|Baseline|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
135390|NCT01633892|P1|Participant Flow|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
135391|NCT01633892|O1|Outcome|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
135392|NCT01633892|O1|Outcome|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
135393|NCT01633892|O1|Outcome|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
135394|NCT01633892|O1|Outcome|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
135395|NCT01633892|O1|Outcome|Fat Grafting|Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
135419|NCT01633827|O2|Outcome|Treatment Data|These results represent the ventilation through a active airway (when pharyngeal dilator muscles maximally recruited) at atmospheric pressure during eszopiclone and oxygen administration
135529|NCT01632683|O2|Outcome|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation
Glidescope: Glidescope arm"
135396|NCT01633892|E1|Reported Event|Fat Grafting|"Autologous fat grafting is a potential solution. Grafting of autologous fat tissue is a minimally invasive surgical technique that starts with the harvest of fat tissue from the abdomen or thighs using liposuction through incisions less than 5mm in length. The lipoaspirate is then processed to concentrate the adipose fraction and reinjected into the donor site. This surgical procedure involves the immediate transplantation of a patient’s own tissue in a single operative procedure. It has the advantages of:
Minimal access incisions
Ability to transfer significant amounts of tissue (hundreds of grams of tissue)
Can be used in setting of previous surgical procedures and presence of hardware
Usually performed as outpatient procedure
Minimal donor site morbidity at graft harvest site
Low risk compared with more invasive surgical procedures
Can be repeated multiple times, if necessary, even using the same donor site"
135397|NCT01633853|B3|Baseline|Total|Total of all reporting groups
135398|NCT01633853|B2|Baseline|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
135399|NCT01633853|B1|Baseline|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2."
135400|NCT01633853|P2|Participant Flow|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
135401|NCT01633853|P1|Participant Flow|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2."
135402|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
135403|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2."
135404|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
135405|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2."
135406|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
135407|NCT01633853|O1|Outcome|Vitamin D2 Treatment|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2."
135408|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
135409|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2."
135410|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
135411|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2."
135412|NCT01633853|E2|Reported Event|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
135413|NCT01633853|E1|Reported Event|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2."
135414|NCT01633827|B1|Baseline|Study Group|"This study was a randomized cross-over design so each particiapnt enrolled underweent both placebo and treatment conditions.
During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject demographics for the 20 remaining unselected patients are shown below."
135415|NCT01633827|P2|Participant Flow|Eszopiclone and Oxygen First, Then Placebo and Air|Subjects will receive both eszopiclone and medical grade oxygen (FIO2 0.4) during two overnight sleep studies, after a washout period of 1 week they will receive placebo and air during two overnight sleep studies
135416|NCT01633827|P1|Participant Flow|Placebo and Air First, Then Eszopiclone and Oxygen|Subjects will receive both a sugar pill and room air during two overnight sleep studies first and subsequently eszopiclone 3 mg with oxygen (FiO2 0.4) after a washout period of 1 week.
135417|NCT01633827|O2|Outcome|Treatment Data|This result reports the AHI under the conditions of oxygen and eszopiclone
135418|NCT01633827|O1|Outcome|Placebo Data|This result reports the AHI under the conditions of room air and a placebo tablet.
135420|NCT01633827|O1|Outcome|Placebo Data|These results represent the ventilation through a active airway (when pharyngeal dilator muscles maximally recruited) at atmospheric pressure during the administration of placebo and room air
135421|NCT01633827|O2|Outcome|Treatment Data|These results represent the ventilation through a passive airway (when pharyngeal dilator muscles are not recruited) at atmospheric pressure and eupneic ventilatory drive during eszopiclone and oxygen administration
135422|NCT01633827|O1|Outcome|Placebo Data|These results represent the ventilation through a passive airway (when pharyngeal dilator muscles are not recruited) at atmospheric pressure and eupneic ventilatory drive during the administration of placebo and room air
135423|NCT01633827|O2|Outcome|Treatment Data|These result report the ventilatory control sensitivity (i.e., loop gain) during eszopiclone and oxygen administration
135424|NCT01633827|O1|Outcome|Placebo Data|These results report the ventilatory control sensitivity (i.e., loop gain) during placebo and room air administration
135425|NCT01633827|O2|Outcome|Treatment Data|These result reports the minimum ventilation that can be tolerated before an arousal from sleep under the conditions of oxygen and a sedative.
135426|NCT01633827|O1|Outcome|Placebo Data|These result reports the minimum ventilation that can be tolerated before an arousal from sleep under placebo and room air administration
135427|NCT01633827|E1|Reported Event|Study Group|This study was a randomized cross-over design so each particiapnt enrolled underweent both placebo and treatment conditions
135428|NCT01633814|B1|Baseline|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch
Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
135429|NCT01633814|P1|Participant Flow|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch
Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
135430|NCT01633814|O1|Outcome|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch
Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
135431|NCT01633814|O1|Outcome|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch
Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
135432|NCT01633814|E1|Reported Event|Transdermal Estradiol or Placebo|"Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch
Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1"
135433|NCT01633320|B3|Baseline|Total|Total of all reporting groups
135434|NCT01633320|B2|Baseline|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
135435|NCT01633320|B1|Baseline|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
135436|NCT01633320|P2|Participant Flow|NRS>3 (Moderate to Severe Pain)|Patients with numerical rating scale pain score >3 at arrival in PACU
135437|NCT01633320|P1|Participant Flow|NRS<=3 (no or Mild Pain)|Patients with numerical rating pain scale <=3 at arrival in PACU
135438|NCT01633320|O2|Outcome|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
135439|NCT01633320|O1|Outcome|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
135440|NCT01633320|O2|Outcome|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
135441|NCT01633320|O1|Outcome|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
135442|NCT01633320|E2|Reported Event|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
135443|NCT01633320|E1|Reported Event|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
135444|NCT01632995|B1|Baseline|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
135445|NCT01632995|P1|Participant Flow|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
135446|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
135447|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
135448|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
135449|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
135450|NCT01632995|O1|Outcome|Participants With DBS Testing|All study participants who had at least 1 DBS result
135451|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
135452|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
135453|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
135456|NCT01632995|E1|Reported Event|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
135457|NCT01632904|B3|Baseline|Total|Total of all reporting groups
135458|NCT01632904|B2|Baseline|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.
Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
135459|NCT01632904|B1|Baseline|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.
HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
135460|NCT01632904|P2|Participant Flow|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.
Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
135461|NCT01632904|P1|Participant Flow|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.
HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
135462|NCT01632904|O2|Outcome|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.
Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
135463|NCT01632904|O1|Outcome|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.
HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
135464|NCT01632904|O2|Outcome|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.
Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
135465|NCT01632904|O1|Outcome|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.
HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
135466|NCT01632904|E2|Reported Event|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.
Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
135467|NCT01632904|E1|Reported Event|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.
HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
135468|NCT01632878|B3|Baseline|Total|Total of all reporting groups
135469|NCT01632878|B2|Baseline|Post Myocardial Infarction Non-Omacor Group|Index post Myocardial Infarction patients screened and not treated with Omacor as decided by physician
135470|NCT01632878|B1|Baseline|Post Myocardial Infarction Omacor Group|Index post Myocardial Infarction patients screened and treated with Omacor as decided by physician
135471|NCT01632878|P1|Participant Flow|Post Myocardial Infarction|One single cohort of Index post Myocardial Infarction patients
135472|NCT01632878|O1|Outcome|Post Myocardial Infarction|Index post Myocardial Infarction patients (Omacor group)
135473|NCT01632878|E1|Reported Event|Post Myocardial Infarction|Index post Myocardial Infarction patients (Omacor group)
135474|NCT01632800|B1|Baseline|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field
High pulsed magnetic fields: Magnetic fields will escalate in strength"
135475|NCT01632800|P1|Participant Flow|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field
High pulsed magnetic fields: Magnetic fields will escalate in strength"
135476|NCT01632800|O1|Outcome|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field
High pulsed magnetic fields: Magnetic fields will escalate in strength"
135477|NCT01632800|E1|Reported Event|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field
High pulsed magnetic fields: Magnetic fields will escalate in strength"
135480|NCT01632735|B1|Baseline|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
135481|NCT01632735|P2|Participant Flow|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
135482|NCT01632735|P1|Participant Flow|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
135483|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
135484|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
135485|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
135486|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
135487|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
135488|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
135489|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
135490|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
135491|NCT01632735|E2|Reported Event|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
135492|NCT01632735|E1|Reported Event|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
135493|NCT01632709|B5|Baseline|Total|Total of all reporting groups
135494|NCT01632709|B4|Baseline|Dry Needling at the Neuroma|
135495|NCT01632709|B3|Baseline|Neuroma Injection of Bupivacaine|
135496|NCT01632709|B2|Baseline|Dry Needling at Sympathetic Ganglion|
135497|NCT01632709|B1|Baseline|Sympathetic Nerve Block of Bupivacaine|
135498|NCT01632709|P4|Participant Flow|Dry Needling at the Neuroma|
135499|NCT01632709|P3|Participant Flow|Neuroma Injection of Bupivacaine|
135500|NCT01632709|P2|Participant Flow|Dry Needling at Sympathetic Ganglion|
135501|NCT01632709|P1|Participant Flow|Sympathetic Nerve Block of Bupivacaine|
135502|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
135503|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
135504|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
135505|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
135506|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
135507|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
135508|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
135509|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
135510|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
135511|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
135512|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
135513|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
135514|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
135515|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
135516|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
135517|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
135518|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
135519|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
135520|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
135521|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
135522|NCT01632709|E2|Reported Event|Treatment Group|
135523|NCT01632709|E1|Reported Event|Placebo/Sham Injection|
135524|NCT01632683|B3|Baseline|Total|Total of all reporting groups
135525|NCT01632683|B2|Baseline|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation
Glidescope: Glidescope arm"
135526|NCT01632683|B1|Baseline|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation
C-MAC: C-MAC arm"
135527|NCT01632683|P2|Participant Flow|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation
Glidescope: Glidescope arm"
135528|NCT01632683|P1|Participant Flow|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation
C-MAC: C-MAC arm"
135603|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135530|NCT01632683|O1|Outcome|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation
C-MAC: C-MAC arm"
135531|NCT01632683|E2|Reported Event|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation
Glidescope: Glidescope arm"
135532|NCT01632683|E1|Reported Event|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation
C-MAC: C-MAC arm"
135533|NCT01632423|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
135534|NCT01632423|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
135535|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
135536|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
135537|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
135538|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
135539|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
135540|NCT01632423|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
135541|NCT01632267|B1|Baseline|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
135542|NCT01632267|P1|Participant Flow|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
135543|NCT01632267|O1|Outcome|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
135544|NCT01632267|E1|Reported Event|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
135545|NCT01632215|B3|Baseline|Total|Total of all reporting groups
135546|NCT01632215|B2|Baseline|Sugar Pill|"Placebo group
Sugar pill: Sugar pill 01 dose"
135547|NCT01632215|B1|Baseline|Preoperative Gabapentine,|"Gabapentine
Gabapentine: Gabapentine 600 mg 01 dose"
135548|NCT01632215|P2|Participant Flow|Sugar Pill|"Placebo group
Sugar pill: Sugar pill 01 dose"
135549|NCT01632215|P1|Participant Flow|Preoperative Gabapentine,|"Gabapentine
Gabapentine: Gabapentine 600 mg 01 dose"
135550|NCT01632215|O2|Outcome|Sugar Pill|"Placebo group
Sugar pill: Sugar pill 01 dose"
135551|NCT01632215|O1|Outcome|Preoperative Gabapentine,|"Gabapentine
Gabapentine: Gabapentine 600 mg 01 dose"
135552|NCT01632215|E2|Reported Event|Sugar Pill|"Placebo group
Sugar pill: Sugar pill 01 dose"
135553|NCT01632215|E1|Reported Event|Preoperative Gabapentine,|"Gabapentine
Gabapentine: Gabapentine 600 mg 01 dose"
135554|NCT01632150|B1|Baseline|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
135555|NCT01632150|P1|Participant Flow|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
135556|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks, then beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion.
135557|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion.
135594|NCT01631864|E2|Reported Event|Amlodipine|Amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
135595|NCT01631864|E1|Reported Event|LCZ696|LCZ696 400 mg plus placebo to Amlodipine once daily for 8 weeks
135604|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135605|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135558|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks, then beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
135559|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
135560|NCT01632150|E1|Reported Event|All Treated Subjects|
135561|NCT01632020|B3|Baseline|Total|Total of all reporting groups
135562|NCT01632020|B2|Baseline|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
135563|NCT01632020|B1|Baseline|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
135564|NCT01632020|P2|Participant Flow|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
135565|NCT01632020|P1|Participant Flow|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
135566|NCT01632020|O2|Outcome|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
135567|NCT01632020|O1|Outcome|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
135568|NCT01632020|O2|Outcome|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
135569|NCT01632020|O1|Outcome|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
135570|NCT01632020|E2|Reported Event|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
135571|NCT01632020|E1|Reported Event|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
135572|NCT01631929|B3|Baseline|Total|Total of all reporting groups
135573|NCT01631929|B2|Baseline|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
135574|NCT01631929|B1|Baseline|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag
One bag: Infusion of dextrose and electrolytes using one bag"
135575|NCT01631929|P2|Participant Flow|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
135576|NCT01631929|P1|Participant Flow|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag
One bag: Infusion of dextrose and electrolytes using one bag"
135577|NCT01631929|O2|Outcome|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
135578|NCT01631929|O1|Outcome|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag
One bag: Infusion of dextrose and electrolytes using one bag"
135579|NCT01631929|E2|Reported Event|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
135580|NCT01631929|E1|Reported Event|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag
One bag: Infusion of dextrose and electrolytes using one bag"
135581|NCT01631864|B3|Baseline|Total|Total of all reporting groups
135582|NCT01631864|B2|Baseline|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
135583|NCT01631864|B1|Baseline|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
135584|NCT01631864|P2|Participant Flow|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
135585|NCT01631864|P1|Participant Flow|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
135586|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
135587|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
135588|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
135589|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
135590|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
135591|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
135592|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
135610|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135611|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135612|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135613|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135614|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135615|NCT01631825|E1|Reported Event|SPM 962|SPM 962 transdermal patch
135616|NCT01631812|B1|Baseline|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
135617|NCT01631812|P1|Participant Flow|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
135618|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135619|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135620|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135621|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135622|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135623|NCT01631812|E1|Reported Event|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
135624|NCT01631682|B5|Baseline|Total|Total of all reporting groups
135625|NCT01631682|B4|Baseline|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.
Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
135626|NCT01631682|B3|Baseline|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Mifepristone: 1800mg, 9 tablets"
135627|NCT01631682|B2|Baseline|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10 minute break and subsequently extinction
Reactivation: subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
135628|NCT01631682|B1|Baseline|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Propranolol: 40mg single pill"
135629|NCT01631682|P4|Participant Flow|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.
Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
135630|NCT01631682|P3|Participant Flow|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Mifepristone: 1800mg, 9 tablets"
135631|NCT01631682|P2|Participant Flow|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.
Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
135632|NCT01631682|P1|Participant Flow|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Propranolol: 40mg single pill"
135633|NCT01631682|O4|Outcome|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.
Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
135634|NCT01631682|O3|Outcome|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Mifepristone: 1800mg, 9 tablets"
135635|NCT01631682|O2|Outcome|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.
Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
135636|NCT01631682|O1|Outcome|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Propranolol: 40mg single pill"
135637|NCT01631682|E4|Reported Event|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.
Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
135638|NCT01631682|E3|Reported Event|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Mifepristone: 1800mg, 9 tablets"
135639|NCT01631682|E2|Reported Event|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.
Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
135640|NCT01631682|E1|Reported Event|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Propranolol: 40mg single pill"
135641|NCT01631630|B3|Baseline|Total|Total of all reporting groups
135642|NCT01631630|B2|Baseline|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135643|NCT01631630|B1|Baseline|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135644|NCT01631630|P2|Participant Flow|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135645|NCT01631630|P1|Participant Flow|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
136138|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
135646|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135647|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135648|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135649|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135650|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135651|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135652|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135653|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135654|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135655|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135656|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135657|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135658|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135659|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135660|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135661|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135662|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135663|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135664|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135665|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135666|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135667|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135668|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135669|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135670|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135671|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135672|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135673|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135674|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135675|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135676|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135677|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135678|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135679|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135680|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135681|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135682|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135683|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135684|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135685|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135686|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135687|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135688|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135689|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135690|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135691|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135692|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135693|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135694|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135695|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135696|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135697|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135698|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135699|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135700|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135701|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135702|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135703|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135704|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135705|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135706|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135707|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135708|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135709|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135710|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135711|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135712|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135713|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135714|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135715|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135716|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135717|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135718|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135719|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135720|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135721|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135722|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135723|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135724|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135725|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135726|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135727|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135728|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135729|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135730|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135731|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135732|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135733|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135734|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135735|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135736|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135737|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135738|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135739|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135740|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135741|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135742|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135743|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135744|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135745|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135746|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135747|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135748|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135749|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135750|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135751|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135752|NCT01631630|E2|Reported Event|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
135753|NCT01631630|E1|Reported Event|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
135754|NCT01631435|B1|Baseline|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.
Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.
Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure
• Ileocolonoscopy with intubation of terminal ileum"
135755|NCT01631435|P1|Participant Flow|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.
Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.
Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure
• Ileocolonoscopy with intubation of terminal ileum"
135756|NCT01631435|O2|Outcome|# Casesclassified as “Active CD is Likely” by IC|"The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the Ileo colonoscopy (IC) procedure.
“Active Crohn’s disease” included the followings lesions:
Aphthous ulceration
Ulcers (other than Aphthous)
Bleeding
Inflammatory stricture Lesions other than the above list were classified as “Non active Crohn’s disease.”"
135757|NCT01631435|O1|Outcome|# Casesclassified as “Active CD is Likely” by CE|"The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the CD capsule endoscopy(CE).
“Active Crohn’s disease” included the followings lesions:
Aphthous ulceration
Ulcers (other than Aphthous)
Bleeding
Inflammatory stricture Lesions other than the above list were classified as “Non active Crohn’s disease.”"
135758|NCT01631435|E1|Reported Event|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.
Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.
Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure
• Ileocolonoscopy with intubation of terminal ileum"
135759|NCT01631227|B3|Baseline|Total|Total of all reporting groups
135760|NCT01631227|B2|Baseline|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
135761|NCT01631227|B1|Baseline|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
135762|NCT01631227|P2|Participant Flow|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
135763|NCT01631227|P1|Participant Flow|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
135764|NCT01631227|O2|Outcome|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
135765|NCT01631227|O1|Outcome|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
135766|NCT01631227|E2|Reported Event|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
135767|NCT01631227|E1|Reported Event|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
135768|NCT01631149|B3|Baseline|Total|Total of all reporting groups
135849|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135769|NCT01631149|B2|Baseline|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
135770|NCT01631149|B1|Baseline|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
135851|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135771|NCT01631149|P2|Participant Flow|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
135772|NCT01631149|P1|Participant Flow|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
135773|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
135774|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
135775|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
135776|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
135777|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
135778|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
135779|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
135780|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
135781|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
135782|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
135783|NCT01631149|E2|Reported Event|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
135784|NCT01631149|E1|Reported Event|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
135785|NCT01631110|B3|Baseline|Total|Total of all reporting groups
135786|NCT01631110|B2|Baseline|Adults From 18 to 60 Years Old Inclusive|
135787|NCT01631110|B1|Baseline|Elderly Subjects Aged Over 60 Years|
135788|NCT01631110|P2|Participant Flow|Adults From 18 to 60 Years Old Inclusive|
135789|NCT01631110|P1|Participant Flow|Elderly Subjects Aged Over 60 Years|
135790|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
135791|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
135792|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
135793|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
135794|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
135795|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
135796|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
135797|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
135798|NCT01631110|E2|Reported Event|Adults From 18 to 60 Years Old Inclusive|
135799|NCT01631110|E1|Reported Event|Elderly Subjects Aged Over 60 Years|
135800|NCT01631071|B3|Baseline|Total|Total of all reporting groups
135801|NCT01631071|B2|Baseline|Adults From 18 to 60 Years Old Inclusive|
135802|NCT01631071|B1|Baseline|Elderly Subjects Aged Over 60 Years|
135803|NCT01631071|P2|Participant Flow|Adults From 18 to 60 Years Old Inclusive|
135804|NCT01631071|P1|Participant Flow|Elderly Subjects Aged Over 60 Years|
135805|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
135806|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
135807|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
135808|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
135809|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
135810|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
135811|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
135812|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
135813|NCT01631071|E2|Reported Event|Adults From 18 to 60 Years Old Inclusive|
135814|NCT01631071|E1|Reported Event|Elderly Subjects Aged Over 60 Years|
135815|NCT01630694|B3|Baseline|Total|Total of all reporting groups
135816|NCT01630694|B2|Baseline|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.
3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
135817|NCT01630694|B1|Baseline|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.
3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
135932|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
145172|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
135818|NCT01630694|P2|Participant Flow|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.
3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
136141|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
135819|NCT01630694|P1|Participant Flow|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.
3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
135820|NCT01630694|O2|Outcome|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.
3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
135821|NCT01630694|O1|Outcome|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.
3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
135822|NCT01630694|O2|Outcome|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.
3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
135823|NCT01630694|O1|Outcome|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.
3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
135824|NCT01630694|E2|Reported Event|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.
3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
135825|NCT01630694|E1|Reported Event|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.
3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
135826|NCT01630135|B3|Baseline|Total|Total of all reporting groups
135827|NCT01630135|B2|Baseline|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135828|NCT01630135|B1|Baseline|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135829|NCT01630135|P2|Participant Flow|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135830|NCT01630135|P1|Participant Flow|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135831|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135832|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135833|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135834|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135835|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135836|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135837|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135838|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135839|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135840|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135841|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135842|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135843|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135844|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135845|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135846|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135847|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135848|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135850|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
136142|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
135852|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135853|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135854|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135855|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135856|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135857|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135858|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135859|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135860|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135861|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135862|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135863|NCT01630135|E2|Reported Event|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
135864|NCT01630135|E1|Reported Event|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
135865|NCT01630109|B4|Baseline|Total|Total of all reporting groups
135866|NCT01630109|B3|Baseline|Placebo Control|Placebo to be used as the control group
135867|NCT01630109|B2|Baseline|Metoclopramide 10 mg|Pro-motility agent
135868|NCT01630109|B1|Baseline|Metoclopramide 5 mg|Pro-motility agent
135869|NCT01630109|P3|Participant Flow|Placebo Control|Placebo to be used as the control group
135870|NCT01630109|P2|Participant Flow|Metoclopramide 10 mg|Pro-motility agent
135871|NCT01630109|P1|Participant Flow|Metoclopramide 5 mg|Pro-motility agent
135872|NCT01630109|O6|Outcome|Placebo (Non-diabetic)|Placebo control given to non-diabetics
135873|NCT01630109|O5|Outcome|Metoclopramide 10 mg (Non-diabetic)|Pro-motility agent given to non-diabetic patients
135874|NCT01630109|O4|Outcome|Metoclopramide 5 mg (Non-diabetic)|Pro-motility agent given to non-diabetic patients
135875|NCT01630109|O3|Outcome|Placebo Control (Diabetics)|Placebo to be used as the control group in diabetic patients
135876|NCT01630109|O2|Outcome|Metoclopramide 10 mg (Diabetics)|Pro-motility agent given to diabetic patients
135877|NCT01630109|O1|Outcome|Metoclopramide 5 mg (Diabetics)|Pro-motility agent given to diabetic patients
135878|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
135879|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
135880|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
135881|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
135882|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
135883|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
135884|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
135885|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
135886|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
135887|NCT01630109|E3|Reported Event|Placebo Control|Placebo to be used as the control group
135888|NCT01630109|E2|Reported Event|Metoclopramide 10 mg|Pro-motility agent
135889|NCT01630109|E1|Reported Event|Metoclopramide 5 mg|Pro-motility agent
135890|NCT01629823|B4|Baseline|Total|Total of all reporting groups
135891|NCT01629823|B3|Baseline|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
135892|NCT01629823|B2|Baseline|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
135893|NCT01629823|B1|Baseline|CPAP Less Than 1 cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
135933|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
145173|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
135894|NCT01629823|P3|Participant Flow|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
135895|NCT01629823|P2|Participant Flow|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
135896|NCT01629823|P1|Participant Flow|CPAP Less Than 1 cm Water (H₂O)|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
135897|NCT01629823|O3|Outcome|CPAP 10cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
135898|NCT01629823|O2|Outcome|CPAP 5cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
135899|NCT01629823|O1|Outcome|CPAP Less Than 1 cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
135900|NCT01629823|E3|Reported Event|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
135901|NCT01629823|E2|Reported Event|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
135902|NCT01629823|E1|Reported Event|CPAP Less Than 1 cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
135903|NCT01629797|B1|Baseline|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
135904|NCT01629797|P1|Participant Flow|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
135905|NCT01629797|O2|Outcome|Two Months Post-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
135906|NCT01629797|O1|Outcome|Pre-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
135907|NCT01629797|O2|Outcome|Post-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture.
135934|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
145174|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
135935|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
135936|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
137753|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
135908|NCT01629797|O1|Outcome|Pre-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture.
135909|NCT01629797|E1|Reported Event|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
135910|NCT01629784|B1|Baseline|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
135911|NCT01629784|P1|Participant Flow|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
135912|NCT01629784|O2|Outcome|Three Months Post-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.
135913|NCT01629784|O1|Outcome|Pre-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.
135914|NCT01629784|O2|Outcome|Post-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.
135915|NCT01629784|O1|Outcome|Pre-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.
135916|NCT01629784|E1|Reported Event|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
135917|NCT01629771|B3|Baseline|Total|Total of all reporting groups
135918|NCT01629771|B2|Baseline|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
135919|NCT01629771|B1|Baseline|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
135920|NCT01629771|P2|Participant Flow|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
135921|NCT01629771|P1|Participant Flow|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
135922|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
135923|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
135924|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
135925|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
135926|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
135927|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
135928|NCT01629771|E2|Reported Event|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
135929|NCT01629771|E1|Reported Event|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
135930|NCT01629706|B1|Baseline|Overall|All enrolled participants
135931|NCT01629706|P1|Participant Flow|PureVision/Habitual|Phase 1: Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for two hours and four hours at a time, separate days, with Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in the fellow eye. Phase 2: Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care.
136135|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
135937|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
135938|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
135939|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
135940|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
135941|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
135942|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
135943|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
135944|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
135945|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
135946|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
135947|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
135948|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
135949|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
135950|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
135951|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
135952|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
135953|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
135954|NCT01629706|E2|Reported Event|Habitual|Habitual contact lenses worn in Phase 2
135955|NCT01629706|E1|Reported Event|PureVision|Balafilcon A contact lenses worn in Phase 1
135956|NCT01629693|B3|Baseline|Total|Total of all reporting groups
135957|NCT01629693|B2|Baseline|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
135958|NCT01629693|B1|Baseline|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
135959|NCT01629693|P2|Participant Flow|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
135960|NCT01629693|P1|Participant Flow|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
135961|NCT01629693|O2|Outcome|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
135962|NCT01629693|O1|Outcome|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
135963|NCT01629693|E2|Reported Event|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
135964|NCT01629693|E1|Reported Event|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
135965|NCT01629667|B4|Baseline|Total|Total of all reporting groups
135966|NCT01629667|B3|Baseline|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
135967|NCT01629667|B2|Baseline|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
135968|NCT01629667|B1|Baseline|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
135969|NCT01629667|P3|Participant Flow|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
135970|NCT01629667|P2|Participant Flow|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
135971|NCT01629667|P1|Participant Flow|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
135972|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
135973|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
135974|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
135975|NCT01629667|O2|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
135976|NCT01629667|O1|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
135977|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
135978|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
135979|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
135980|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
135981|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
135982|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
135983|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
137754|NCT01618942|E2|Reported Event|Female Subjects|grouped by gender
135984|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
135985|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
135986|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
135987|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
135988|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
135989|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
135990|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
135991|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
135992|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
135993|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
135994|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
135995|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
135996|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
135997|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
135998|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
135999|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136000|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136001|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136002|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136003|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136004|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136005|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136006|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136007|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136008|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136009|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136010|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136011|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136012|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136013|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136014|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136015|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136016|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136017|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136018|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136019|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136020|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136021|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136022|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136023|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136024|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136025|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136026|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136027|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136028|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136029|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136030|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136031|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136032|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136033|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136034|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136035|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136036|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136037|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136038|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136039|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136040|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136041|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136042|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136043|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136044|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136045|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136046|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136047|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136048|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136049|NCT01629667|E3|Reported Event|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
136050|NCT01629667|E2|Reported Event|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
136051|NCT01629667|E1|Reported Event|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
136052|NCT01629589|B3|Baseline|Total|Total of all reporting groups
136053|NCT01629589|B2|Baseline|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
136054|NCT01629589|B1|Baseline|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
136055|NCT01629589|P2|Participant Flow|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
136056|NCT01629589|P1|Participant Flow|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
136057|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
136058|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
136059|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
136060|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
136061|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
136062|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
136063|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
136064|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
136065|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
136066|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
136067|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
136068|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
136069|NCT01629589|E2|Reported Event|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
136070|NCT01629589|E1|Reported Event|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
136071|NCT01629290|B1|Baseline|Varnish and Placebo|Three dental varnishes with 5% NaF active ingredient and placebo bland varnish containing no NaF
136072|NCT01629290|P1|Participant Flow|Varnishes and Placebo|"Three dental varnishes with 5% NaF active ingredient (Enamel Pro, Duraphat and Vanish) and one bland varnish with no NaF applied to each subject at four timepoints.
Each of the 15 participants received each of the four treatments, but the order followed was randomly arranged to be different, so there were twelve different patterns of assignment. Because all participants completed all four interventions, and the order was different for each, milestones are not used to indicate participation in each treatment, as that might imply a sequence, rather than simply that they received that intervention."
136073|NCT01629290|O4|Outcome|Placebo|Bland varnish containing no NaF
136074|NCT01629290|O3|Outcome|Vanish|Dental varnish with 5% NaF active ingredient
136075|NCT01629290|O2|Outcome|Duraphat|Dental varnish with 5% NaF active ingredient
136076|NCT01629290|O1|Outcome|Enamel Pro|Dental varnish with 5% NaF active ingredient
136077|NCT01629290|E4|Reported Event|Vanish|Dental varnish with 5% NaF active ingredient
136078|NCT01629290|E3|Reported Event|Duraphat|Dental varnish with 5% NaF active ingredient
136079|NCT01629290|E2|Reported Event|Placebo|Placebo bland varnish containing no NaF
136080|NCT01629290|E1|Reported Event|Enamel Pro|Dental varnish with 5% NaF active ingredient
136081|NCT01629134|B1|Baseline|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136082|NCT01629134|P1|Participant Flow|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136136|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136137|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136083|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136084|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136085|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136086|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136087|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136088|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136089|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136090|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136091|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136092|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136093|NCT01629134|E1|Reported Event|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
136094|NCT01628965|B1|Baseline|SPM 962|SPM 962 transdermal patch
136095|NCT01628965|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
136096|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136097|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136098|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136099|NCT01628965|E1|Reported Event|SPM 962|SPM 962 transdermal patch
136100|NCT01628926|B4|Baseline|Total|Total of all reporting groups
136101|NCT01628926|B3|Baseline|Placebo|SPM962 placebo patch and Ropinirole placebo tab
136102|NCT01628926|B2|Baseline|Ropinirole|Ropinirole tablet
136103|NCT01628926|B1|Baseline|SPM 962|SPM 962 transdermal patch
136104|NCT01628926|P3|Participant Flow|Placebo|SPM962 placebo patch and Ropinirole placebo tab
136105|NCT01628926|P2|Participant Flow|Ropinirole|Ropinirole tablet
136106|NCT01628926|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
136107|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136108|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
136109|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136110|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab.
136111|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
136112|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136113|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136114|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
136115|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136116|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136117|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
136118|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136119|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136120|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
136121|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136122|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136123|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
136124|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136125|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab.
136126|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
136127|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136128|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136129|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
136130|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136131|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136132|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
136133|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136134|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136139|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136140|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136143|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136144|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
136145|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136146|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
136147|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
136148|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
136149|NCT01628926|E3|Reported Event|Placebo|SPM962 placebo patch and Ropinirole placebo tab
136150|NCT01628926|E2|Reported Event|Ropinirole|Ropinirole tablet
136151|NCT01628926|E1|Reported Event|SPM 962|SPM 962 transdermal patch
136152|NCT01628913|B3|Baseline|Total|Total of all reporting groups
136153|NCT01628913|B2|Baseline|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
136154|NCT01628913|B1|Baseline|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
136155|NCT01628913|P2|Participant Flow|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
136156|NCT01628913|P1|Participant Flow|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
136157|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
136158|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
136159|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
136160|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
136161|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
136162|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
136163|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
136164|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
136165|NCT01628913|E2|Reported Event|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
136166|NCT01628913|E1|Reported Event|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
136167|NCT01628848|B3|Baseline|Total|Total of all reporting groups
136168|NCT01628848|B2|Baseline|Placebo|Placebo transdermal patch
136169|NCT01628848|B1|Baseline|SPM 962|SPM 962 transdermal patch
136170|NCT01628848|P2|Participant Flow|Placebo|Placebo transdermal patch
136171|NCT01628848|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
136172|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136173|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136174|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136175|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136176|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136177|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136178|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136179|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136180|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136181|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136182|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136183|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136184|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136185|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136186|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136187|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136188|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136189|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136190|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136191|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136192|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136193|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136194|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
136195|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
136196|NCT01628848|E2|Reported Event|Placebo|Placebo transdermal patch
136197|NCT01628848|E1|Reported Event|SPM 962|SPM 962 transdermal patch
136198|NCT01628692|B7|Baseline|Total|Total of all reporting groups
136199|NCT01628692|B6|Baseline|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136200|NCT01628692|B5|Baseline|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136215|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136713|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
136274|NCT01628588|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
136275|NCT01628510|B3|Baseline|Total|Total of all reporting groups
136375|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136201|NCT01628692|B4|Baseline|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
136202|NCT01628692|B3|Baseline|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136203|NCT01628692|B2|Baseline|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136204|NCT01628692|B1|Baseline|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
136205|NCT01628692|P6|Participant Flow|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136206|NCT01628692|P5|Participant Flow|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136207|NCT01628692|P4|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
136208|NCT01628692|P3|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136209|NCT01628692|P2|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136210|NCT01628692|P1|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
136211|NCT01628692|O3|Outcome|Genotype1a: Daclatasvir +Simeprevir + Ribavirin(Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136212|NCT01628692|O2|Outcome|Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136213|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
136214|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136231|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
136216|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
136217|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136218|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136219|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
136220|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136221|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136222|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
136223|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136224|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136225|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
136226|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136227|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136228|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
136229|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136230|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136271|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
136232|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136233|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136234|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136235|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136236|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up
136237|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
136238|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136239|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136240|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136241|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136242|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136243|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
136244|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
136245|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136246|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
136272|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
136273|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
136247|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136248|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136249|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
136250|NCT01628692|E3|Reported Event|Genotype1a: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
136251|NCT01628692|E2|Reported Event|Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
136252|NCT01628692|E1|Reported Event|Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
136253|NCT01628614|B1|Baseline|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
136254|NCT01628614|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
136255|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
136256|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
136257|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
136258|NCT01628614|E1|Reported Event|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
136259|NCT01628601|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
136260|NCT01628601|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
136261|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
136262|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
136263|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
136264|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
136265|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
136266|NCT01628601|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
136267|NCT01628588|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
136268|NCT01628588|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
136269|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
136270|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
136421|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136276|NCT01628510|B2|Baseline|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
136277|NCT01628510|B1|Baseline|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization."
136278|NCT01628510|P2|Participant Flow|Traditional NICU Positioning|Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
136279|NCT01628510|P1|Participant Flow|Dandle Roo/Dandle Wrap|The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
136280|NCT01628510|O2|Outcome|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
136281|NCT01628510|O1|Outcome|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization."
136282|NCT01628510|E2|Reported Event|Traditional NICU Positioning|Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
136283|NCT01628510|E1|Reported Event|Dandle Roo/Dandle Wrap|The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
136284|NCT01628367|B3|Baseline|Total|Total of all reporting groups
136285|NCT01628367|B2|Baseline|Control|"Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
136286|NCT01628367|B1|Baseline|Test|"Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
136287|NCT01628367|P2|Participant Flow|Control|"Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
136288|NCT01628367|P1|Participant Flow|Test|"Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
136289|NCT01628367|O2|Outcome|Control|"Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
145175|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
136374|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136535|NCT01627002|P5|Participant Flow|Part A PA401 10 mg|
136290|NCT01628367|O1|Outcome|Test|"Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
136291|NCT01628367|O2|Outcome|Control|"Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
136292|NCT01628367|O1|Outcome|Test|"Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
136293|NCT01628367|O2|Outcome|Control|"Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
136294|NCT01628367|O1|Outcome|Test|"Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
136295|NCT01628367|E2|Reported Event|Control|"Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
136296|NCT01628367|E1|Reported Event|Test|"Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
136297|NCT01628250|B3|Baseline|Total|Total of all reporting groups
136298|NCT01628250|B2|Baseline|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection
D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
136299|NCT01628250|B1|Baseline|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision
laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
136300|NCT01628250|P2|Participant Flow|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection
D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
136301|NCT01628250|P1|Participant Flow|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision
laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
136302|NCT01628250|O2|Outcome|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection
D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
136303|NCT01628250|O1|Outcome|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision
laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
136304|NCT01628250|E2|Reported Event|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection
D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
136532|NCT01627002|P8|Participant Flow|Part B PA401 3.0 mg|PA401 3.0 mg was administered 30 minutes after lipopolysaccharide challenge
136305|NCT01628250|E1|Reported Event|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision
laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
136306|NCT01628042|B5|Baseline|Total|Total of all reporting groups
136307|NCT01628042|B4|Baseline|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
136308|NCT01628042|B3|Baseline|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136309|NCT01628042|B2|Baseline|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136310|NCT01628042|B1|Baseline|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136311|NCT01628042|P4|Participant Flow|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
136312|NCT01628042|P3|Participant Flow|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136313|NCT01628042|P2|Participant Flow|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136314|NCT01628042|P1|Participant Flow|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136315|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
136316|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136317|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136318|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136319|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
136320|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136321|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136322|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136323|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
136324|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136325|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136326|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136327|NCT01628042|E4|Reported Event|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
136328|NCT01628042|E3|Reported Event|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136329|NCT01628042|E2|Reported Event|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136330|NCT01628042|E1|Reported Event|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
136331|NCT01627860|B3|Baseline|Total|Total of all reporting groups
136332|NCT01627860|B2|Baseline|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136333|NCT01627860|B1|Baseline|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136334|NCT01627860|P2|Participant Flow|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136335|NCT01627860|P1|Participant Flow|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136336|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136337|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136373|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
145176|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
136338|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136339|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136340|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136341|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136342|NCT01627860|E2|Reported Event|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136343|NCT01627860|E1|Reported Event|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
136344|NCT01627782|B5|Baseline|Total|Total of all reporting groups
136345|NCT01627782|B4|Baseline|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136346|NCT01627782|B3|Baseline|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136347|NCT01627782|B2|Baseline|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136348|NCT01627782|B1|Baseline|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136349|NCT01627782|P4|Participant Flow|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136350|NCT01627782|P3|Participant Flow|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136351|NCT01627782|P2|Participant Flow|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136352|NCT01627782|P1|Participant Flow|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136353|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136354|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136355|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136356|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136357|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136358|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136359|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136360|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136361|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136362|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136363|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136364|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136365|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136366|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136367|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136368|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136369|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136370|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136371|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136372|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136710|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
136376|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136377|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136378|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136379|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136380|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136381|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136382|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136383|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136384|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136385|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136386|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136387|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136388|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136389|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136390|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136391|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136392|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136393|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136394|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136395|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136396|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136397|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136398|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136399|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136400|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136401|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136402|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136403|NCT01627782|E4|Reported Event|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
136404|NCT01627782|E3|Reported Event|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
136405|NCT01627782|E2|Reported Event|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
136406|NCT01627782|E1|Reported Event|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
136407|NCT01627561|B3|Baseline|Total|Total of all reporting groups
136408|NCT01627561|B2|Baseline|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136409|NCT01627561|B1|Baseline|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136410|NCT01627561|P2|Participant Flow|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136411|NCT01627561|P1|Participant Flow|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136412|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136413|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136414|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136415|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136416|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136417|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136418|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136419|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136420|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136422|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136423|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136424|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136425|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136426|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136427|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136428|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136429|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136430|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136431|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136432|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136433|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136434|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136435|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136436|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136437|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136438|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136439|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136440|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136441|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136442|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136443|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136444|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136445|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136446|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136447|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136448|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136449|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136450|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136451|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136452|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136453|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136454|NCT01627561|E2|Reported Event|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
136455|NCT01627561|E1|Reported Event|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
136456|NCT01627340|B3|Baseline|Total|Total of all reporting groups
136457|NCT01627340|B2|Baseline|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
136458|NCT01627340|B1|Baseline|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
136459|NCT01627340|P2|Participant Flow|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
136460|NCT01627340|P1|Participant Flow|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
136461|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of EngerixTM-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
136462|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of EngerixTM-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
145177|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
136463|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
136464|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
136465|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
136466|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
136467|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
136468|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
136469|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
136470|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
136471|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
136472|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
136473|NCT01627340|E2|Reported Event|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
136474|NCT01627340|E1|Reported Event|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
136475|NCT01627327|B3|Baseline|Total|Total of all reporting groups
136476|NCT01627327|B2|Baseline|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
136477|NCT01627327|B1|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
136478|NCT01627327|P2|Participant Flow|TIO 18 µg OD|Participants received tiotropium bromide (TIO) 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
136479|NCT01627327|P1|Participant Flow|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) inhalation once daily (OD) via a dry powder inhaler (DPI) and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
136480|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
136481|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
136482|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
136483|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
136484|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
136485|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
136486|NCT01627327|E2|Reported Event|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
136487|NCT01627327|E1|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
136488|NCT01627249|B4|Baseline|Total|Total of all reporting groups
136489|NCT01627249|B3|Baseline|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136490|NCT01627249|B2|Baseline|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136491|NCT01627249|B1|Baseline|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136492|NCT01627249|P3|Participant Flow|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136493|NCT01627249|P2|Participant Flow|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136494|NCT01627249|P1|Participant Flow|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136495|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
136496|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136497|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136498|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
136499|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136500|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136501|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
136502|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136503|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136504|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
136505|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136506|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136507|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
136508|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136509|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136510|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
136511|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136512|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136513|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
136514|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136515|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136516|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
136517|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136518|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136519|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
136520|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136521|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136522|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
136523|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136524|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136525|NCT01627249|E3|Reported Event|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136526|NCT01627249|E2|Reported Event|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
136527|NCT01627249|E1|Reported Event|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
136528|NCT01627002|B3|Baseline|Total|Total of all reporting groups
136529|NCT01627002|B2|Baseline|Part B|
136530|NCT01627002|B1|Baseline|Part A|
136531|NCT01627002|P9|Participant Flow|Part B Placebo|Placebo was administered 30 minutes after lipopolysaccharide challenge
136711|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
136533|NCT01627002|P7|Participant Flow|Part B PA401 1.0 mg|PA401 1.0 mg was administered 30 minutes after lipopolysaccharide challenge
136534|NCT01627002|P6|Participant Flow|Part A Placebo|
136590|NCT01626820|B2|Baseline|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
136591|NCT01626820|B1|Baseline|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136592|NCT01626820|P2|Participant Flow|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm at Day 0
136593|NCT01626820|P1|Participant Flow|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136594|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
136595|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136596|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
136597|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136598|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136599|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136600|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
136601|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136602|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
136603|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136604|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
136605|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136606|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
136607|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136608|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136609|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136610|NCT01626820|E2|Reported Event|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
136611|NCT01626820|E1|Reported Event|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
136612|NCT01626690|B3|Baseline|Total|Total of all reporting groups
136613|NCT01626690|B2|Baseline|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
136614|NCT01626690|B1|Baseline|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
136615|NCT01626690|P2|Participant Flow|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
136616|NCT01626690|P1|Participant Flow|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
136617|NCT01626690|O2|Outcome|SpotOn (3M) Temperature Readings.|Patient temperature at time of incision as measured by SpotOn (3M) temperature monitoring system.
136618|NCT01626690|O1|Outcome|Temporal Artery Thermometer|Patient temperature at time of incision as measured by temporal artery thermometer.
136619|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
136620|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
136621|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
136622|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
136623|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
136624|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
136625|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
136626|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
136627|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
136628|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
136629|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
136630|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
136631|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
136632|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
136633|NCT01626690|E2|Reported Event|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
136634|NCT01626690|E1|Reported Event|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
136635|NCT01626456|B3|Baseline|Total|Total of all reporting groups
136636|NCT01626456|B2|Baseline|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
136637|NCT01626456|B1|Baseline|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
136638|NCT01626456|P2|Participant Flow|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
136639|NCT01626456|P1|Participant Flow|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
136640|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
136641|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
136642|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
136643|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
136644|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
136645|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
136646|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
136647|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
136648|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
136649|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
136650|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study.
136651|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in the base study and the current study.
136652|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
136653|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in the base study and in the current study.
136654|NCT01626456|O1|Outcome|PBO-440 mg|Subjects who received placebo in the base study and low dose in the current study
136655|NCT01626456|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
136656|NCT01626456|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
136657|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
136658|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
136659|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
136660|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
136661|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
136662|NCT01626456|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
136663|NCT01626456|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
136664|NCT01626456|E2|Reported Event|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
136665|NCT01626456|E1|Reported Event|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
136666|NCT01626391|B3|Baseline|Total|Total of all reporting groups
136667|NCT01626391|B2|Baseline|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
136668|NCT01626391|B1|Baseline|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
136669|NCT01626391|P2|Participant Flow|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
136670|NCT01626391|P1|Participant Flow|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
136671|NCT01626391|O2|Outcome|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
136672|NCT01626391|O1|Outcome|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
136673|NCT01626391|E2|Reported Event|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
136674|NCT01626391|E1|Reported Event|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
136675|NCT01626118|B5|Baseline|Total|Total of all reporting groups
136676|NCT01626118|B4|Baseline|Placebo|Placebo Group
136677|NCT01626118|B3|Baseline|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
136678|NCT01626118|B2|Baseline|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
136679|NCT01626118|B1|Baseline|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
136681|NCT01626118|P3|Participant Flow|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
136682|NCT01626118|P2|Participant Flow|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
136683|NCT01626118|P1|Participant Flow|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
136684|NCT01626118|O4|Outcome|Placebo|Placebo Group
136685|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
136686|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
136687|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
136688|NCT01626118|O4|Outcome|Placebo|Placebo Group
136689|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
136690|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
136691|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
136692|NCT01626118|O4|Outcome|Placebo|Placebo Group
136693|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
136694|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
136695|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
136696|NCT01626118|O4|Outcome|Placebo|Placebo Group
136697|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
136698|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
136699|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
136700|NCT01626118|O4|Outcome|Placebo|Placebo Group
136701|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
136702|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
136703|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
136704|NCT01626118|O4|Outcome|Placebo|Placebo Group
136705|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
136706|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
136707|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
136708|NCT01626118|O4|Outcome|Placebo|Placebo Group
136709|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
136714|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
136715|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
136716|NCT01626118|E4|Reported Event|Placebo|Placebo Group
136717|NCT01626118|E3|Reported Event|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
136718|NCT01626118|E2|Reported Event|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
136719|NCT01626118|E1|Reported Event|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
136720|NCT01626092|B1|Baseline|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.
Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8
Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9"
136721|NCT01626092|P1|Participant Flow|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.
Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.
Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
136722|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.
Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.
Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
136738|NCT01625845|B2|Baseline|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136723|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.
Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.
Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
136724|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.
Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.
Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
136725|NCT01626092|E1|Reported Event|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.
Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8
Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9"
136726|NCT01625910|B3|Baseline|Total|Total of all reporting groups
136727|NCT01625910|B2|Baseline|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
136761|NCT01625689|P2|Participant Flow|Placebo|Inactive placebo was identical to SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
136763|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
136947|NCT01624350|O2|Outcome|Permacol Collagen Paste - 12 Month Follow up|
136728|NCT01625910|B1|Baseline|Intervention - Behavioral Counseling|"The intervention group received management patterned after the Prevention plus, Stage 1 treatment recommended by the expert panel and approved by the committee. Counseling was primarily directed toward the parents. The RA used motivational interviewing (MI) techniques as an entry way to discuss healthy lifestyle habits around eating and physical activity (e.g., open-ended questions, reflective listening, discrepancy questions, eliciting change talk). Evidence-based recommendations for childhood obesity treatment were discussed with the parent; such as, eating breakfast daily, eating ≥ 5 servings of fruits and vegetables/day, avoidance of skipping meals, watching ≤ 2 hours of screen time/day, minimizing or eliminating sugar-sweetened beverages, encouraging family meals at home, and being physically active ≥ 1 hour/day.
There were monthly follow-up phone calls to try and encourage continued success in healthy lifestyle choices."
136729|NCT01625910|P2|Participant Flow|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
136730|NCT01625910|P1|Participant Flow|Intervention - Behavioral Counseling|The intervention group received management patterned after the
136731|NCT01625910|O2|Outcome|Control|Change in cans of sugar sweetened beverages per day
136732|NCT01625910|O1|Outcome|Intervention Group|"The survey done at baseline and follow-up asked about daily cans of sugar-sweetened beverages.
Estimate is for Change in cans of sugar sweetened beverages per day"
136733|NCT01625910|O2|Outcome|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
136734|NCT01625910|O1|Outcome|Intervention - Behavioral Counseling|The intervention group received management patterned after the
136735|NCT01625910|E2|Reported Event|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
136736|NCT01625910|E1|Reported Event|Intervention - Behavioral Counseling|"The intervention group received management patterned after the Prevention plus, Stage 1 treatment recommended by the expert panel and approved by the committee. Counseling was primarily directed toward the parents. The RA used motivational interviewing (MI) techniques as an entry way to discuss healthy lifestyle habits around eating and physical activity (e.g., open-ended questions, reflective listening, discrepancy questions, eliciting change talk). Evidence-based recommendations for childhood obesity treatment were discussed with the parent; such as, eating breakfast daily, eating ≥ 5 servings of fruits and vegetables/day, avoidance of skipping meals, watching ≤ 2 hours of screen time/day, minimizing or eliminating sugar-sweetened beverages, encouraging family meals at home, and being physically active ≥ 1 hour/day.
There were monthly follow-up phone calls to try and encourage continued success in healthy lifestyle choices."
136737|NCT01625845|B3|Baseline|Total|Total of all reporting groups
136779|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
136780|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
137755|NCT01618942|E1|Reported Event|Male Subjects|grouped by gender
136739|NCT01625845|B1|Baseline|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136740|NCT01625845|P2|Participant Flow|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136741|NCT01625845|P1|Participant Flow|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136742|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136743|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136744|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136762|NCT01625689|P1|Participant Flow|Serum Institute of India, Ltd. (SIIL) LAIV|The Serum Institute of India, Ltd. (SIIL) live attenuated influenza vaccine (LAIV) (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
136745|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136746|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136747|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136748|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136749|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136750|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136751|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136781|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
136752|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136753|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136754|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136755|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136756|NCT01625845|E2|Reported Event|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136757|NCT01625845|E1|Reported Event|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
136758|NCT01625689|B3|Baseline|Total|Total of all reporting groups
136759|NCT01625689|B2|Baseline|Placebo|Inactive placebo was identical to the SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
136760|NCT01625689|B1|Baseline|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
136764|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
136765|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
136766|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
136767|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
136768|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
136769|NCT01625689|E2|Reported Event|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
136770|NCT01625689|E1|Reported Event|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
136771|NCT01625507|B1|Baseline|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.
PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes, following the recommendations of the Canadian Diabetes Association, 2008"
136772|NCT01625507|P1|Participant Flow|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.
PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes (T2D), following the recommendations of the Canadian Diabetes Association, 2008"
136773|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
136774|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
136775|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
136776|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
136777|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
136778|NCT01625507|O1|Outcome|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.
PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes (T2D), following the recommendations of the Canadian Diabetes Association, 2008"
136782|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
136783|NCT01625507|E1|Reported Event|All Participants|T2D diabetes patients
136784|NCT01625455|B3|Baseline|Total|Total of all reporting groups
136785|NCT01625455|B2|Baseline|Aprepitant Then Placebo.|These subjects received aprepitant during the first week and then crossed over to placebo for the second week.
136786|NCT01625455|B1|Baseline|Placebo Then Aprepitant|These subjects received placebo during the first week and then crossed over to aprepitant for the second week.
136787|NCT01625455|P2|Participant Flow|Aprepitant Then Placebo.|These subjects received aprepitant during the first week and then crossed over to placebo for the second week.
136788|NCT01625455|P1|Participant Flow|Placebo Then Aprepitant|These subjects received placebo during the first week and then crossed over to aprepitant for the second week.
136789|NCT01625455|O2|Outcome|Placebo|"Matching placebo will be given in place of aprepitant
Placebo: Placebo will be given orally for a total of 7 days."
136790|NCT01625455|O1|Outcome|Aprepitant|"Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.
Aprepitant: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days."
136791|NCT01625455|O2|Outcome|Placebo|"Matching placebo will be given in place of aprepitant
Placebo: Placebo will be given orally for a total of 7 days."
136792|NCT01625455|O1|Outcome|Aprepitant|"Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.
Aprepitant: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days."
136793|NCT01625455|E2|Reported Event|Aprepitant|
136794|NCT01625455|E1|Reported Event|Placebo|
136795|NCT01625377|B3|Baseline|Total|Total of all reporting groups
136796|NCT01625377|B2|Baseline|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136797|NCT01625377|B1|Baseline|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136813|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136798|NCT01625377|P2|Participant Flow|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136799|NCT01625377|P1|Participant Flow|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136800|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136801|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136802|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136803|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136804|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136805|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
138702|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
136806|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136807|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136808|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136809|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136810|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136811|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136812|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136814|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136815|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136816|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136817|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136818|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136819|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136820|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136821|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136822|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136823|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136824|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136825|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136826|NCT01625377|E2|Reported Event|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
136827|NCT01625377|E1|Reported Event|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
136828|NCT01625338|B4|Baseline|Total|Total of all reporting groups
136829|NCT01625338|B3|Baseline|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
136830|NCT01625338|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
136831|NCT01625338|B1|Baseline|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
136832|NCT01625338|P3|Participant Flow|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks in participants
136833|NCT01625338|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
136834|NCT01625338|P1|Participant Flow|SOF+RBV 12 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
136835|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
136836|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
136837|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
136838|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
136839|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
136840|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
136841|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
136842|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
136843|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
136844|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
136845|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
136846|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
136847|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
136848|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
136849|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
136850|NCT01625338|E3|Reported Event|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
136851|NCT01625338|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
138564|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
136852|NCT01625338|E1|Reported Event|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
136853|NCT01625221|B1|Baseline|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
136854|NCT01625221|P1|Participant Flow|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
136855|NCT01625221|O1|Outcome|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
136856|NCT01625221|E1|Reported Event|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
136857|NCT01625169|B1|Baseline|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.
There is only one arm- all pregnant women enrolled into the study will receive Etravirine 200mg PO bid for 14 days postpartum"
136858|NCT01625169|P1|Participant Flow|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136859|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136940|NCT01624350|O3|Outcome|Permacol Collagen Paste - 12 Month Post-op|
136860|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136861|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136862|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136863|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136864|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136865|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136866|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136867|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136868|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136869|NCT01625169|E1|Reported Event|HIV + Pregnant Women|"Etravirine PK on days 5 and 14
Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
136870|NCT01625091|B3|Baseline|Total|Total of all reporting groups
136871|NCT01625091|B2|Baseline|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
136872|NCT01625091|B1|Baseline|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
136873|NCT01625091|P2|Participant Flow|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
136874|NCT01625091|P1|Participant Flow|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
136910|NCT01624740|O1|Outcome|Low Rate Subperception Precision SCS Trial Therapy|Stimulation was given at a rate of 2 Hz as either a first or second intervention.
136875|NCT01625091|O2|Outcome|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
136876|NCT01625091|O1|Outcome|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
136877|NCT01625091|O2|Outcome|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
136878|NCT01625091|O1|Outcome|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
136879|NCT01625091|O2|Outcome|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
136880|NCT01625091|O1|Outcome|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
136881|NCT01625091|O2|Outcome|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
136882|NCT01625091|O1|Outcome|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
136883|NCT01625091|E2|Reported Event|Placebo|The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
136884|NCT01625091|E1|Reported Event|Naltrexone|The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
136885|NCT01624948|B3|Baseline|Total|Total of all reporting groups
136886|NCT01624948|B2|Baseline|Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
136887|NCT01624948|B1|Baseline|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
136941|NCT01624350|O2|Outcome|Permacol Collagen Paste - 6 Month Post-op|
136888|NCT01624948|P2|Participant Flow|Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BK polyomavirus (BKV) infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
136889|NCT01624948|P1|Participant Flow|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo mycophenolic acid (MPA) discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
136890|NCT01624948|O2|Outcome|No Rejection|No biopsy-proven rejection episode
136891|NCT01624948|O1|Outcome|Rejection|Any biopsy-proven rejection episode
136892|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
136893|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
136911|NCT01624740|E3|Reported Event|High Frequency Stimulation|Stimulation was given at 1200 Hz.
136912|NCT01624740|E2|Reported Event|Low Frequency Stimulation|Stimulation was given at 2 Hz.
136894|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
136895|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
136896|NCT01624948|O2|Outcome|Failed to Reach Primary Endpoint|
136897|NCT01624948|O1|Outcome|Reached Primary Endpoint|>50% reduction of BKV viruria and/or clearance of BKV viremia
136898|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
136899|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
136900|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
136942|NCT01624350|O1|Outcome|Permacol Collagen Paste - 3 Month Post-op|
136943|NCT01624350|O4|Outcome|Permacol Collagen Paste - 12 Month Post-op|
136901|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
136902|NCT01624948|E2|Reported Event|Standard of Care: 50% Reduction of MPA|Mycophenolic acid dose reduction: continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
136903|NCT01624948|E1|Reported Event|Everolimus+Tacrolimus/Prednisone|Everolimus: MPA discontinuation with the addition of Zortress (everolimus) to current regimen of tacrolimus and prednisone; Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
136904|NCT01624740|B3|Baseline|Total|Total of all reporting groups
136905|NCT01624740|B2|Baseline|High Rate Followed By Low Rate|Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
136906|NCT01624740|B1|Baseline|Low Rate Followed By High Rate|Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
136907|NCT01624740|P2|Participant Flow|High Rate Followed By Low Rate|The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
136908|NCT01624740|P1|Participant Flow|Low Rate Followed By High Rate|The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
136909|NCT01624740|O2|Outcome|High Rate Subperception Precision SCS Trial Therapy|Stimulation was given at a rate of 1200 Hz as either a first or second intervention.
136913|NCT01624740|E1|Reported Event|Trial Lead Insertion|All subjects (n = 20) underwent a lead insertion procedure prior to beginning Period 1 of stimulation. Two of these subjects did not proceed to Period 1 due to insertion difficulties.
136914|NCT01624467|B1|Baseline|Necitumumab|800 mg necitumumab, administered once per week IV
136915|NCT01624467|P1|Participant Flow|Necitumumab|800 milligram (mg) necitumumab, administered once per week as an intravenous infusion (IV)
136916|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
136917|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
136918|NCT01624467|O2|Outcome|Necitumumab: Cycle 1, Day 36|800 mg necitumumab, administered once per week IV
136919|NCT01624467|O1|Outcome|Necitumumab: Cycle 1, Day 1|800 mg necitumumab, administered once per week IV
136920|NCT01624467|O2|Outcome|Necitumumab: Cycle 1, Day 36|800 mg necitumumab, administered once per week IV
136921|NCT01624467|O1|Outcome|Necitumumab: Cycle 1, Day 1|800 mg necitumumab, administered once per week IV
136922|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
136923|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
136924|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
136925|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
136926|NCT01624467|E1|Reported Event|Necitumumab|800 mg necitumumab, administered once per week as an intravenous infusion (IV)
136927|NCT01624363|B1|Baseline|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.
Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
136928|NCT01624363|P1|Participant Flow|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.
Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
136929|NCT01624363|O1|Outcome|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.
Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
136930|NCT01624363|E1|Reported Event|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.
Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
136931|NCT01624350|B1|Baseline|Permacol Collagen Paste|
136932|NCT01624350|P1|Participant Flow|Permacol Collagen Paste|
136933|NCT01624350|O5|Outcome|Permacol Collagen Paste - 12 Month Post-op|
136934|NCT01624350|O4|Outcome|Permacol Collagen Paste - 6 Month Post-op|
136935|NCT01624350|O3|Outcome|Permacol Collagen Paste - 3 Month Post-op|
136936|NCT01624350|O2|Outcome|Permacol Collagen Paste - 1 Month Post-op|
136937|NCT01624350|O1|Outcome|Baseline|
136938|NCT01624350|O2|Outcome|Last Visit|
136939|NCT01624350|O1|Outcome|First Visit|
136952|NCT01624259|B2|Baseline|Liraglutide|"Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks"
136953|NCT01624259|B1|Baseline|LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks"
136954|NCT01624259|P2|Participant Flow|Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks"
136955|NCT01624259|P1|Participant Flow|LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks"
136956|NCT01624259|O2|Outcome|Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks"
136957|NCT01624259|O1|Outcome|LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks"
136958|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136959|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136960|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136961|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136962|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136963|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136964|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136965|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136966|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136967|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
138703|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
136968|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136969|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136970|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136971|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136972|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136973|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136974|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136975|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136976|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136977|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136978|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136979|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136980|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136981|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136982|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136983|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136984|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136985|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136986|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136987|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136988|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136989|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136990|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136991|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136992|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136993|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136994|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136995|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136996|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136997|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
136998|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
137038|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
138704|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
136999|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
137000|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
137001|NCT01624259|E2|Reported Event|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
137002|NCT01624259|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks
Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
137003|NCT01624233|B1|Baseline|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137004|NCT01624233|P1|Participant Flow|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52).
Period 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks."
137005|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137006|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137007|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137084|NCT01623466|O2|Outcome|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5
levonorgestrel: transdermal contraceptive delivery system"
145178|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
137008|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137009|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137010|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137011|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137012|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137013|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137201|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
137014|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137015|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137016|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137017|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137018|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137019|NCT01624233|E1|Reported Event|80 mg Ixekizumab (LY2439821)|"Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
137020|NCT01624168|B4|Baseline|Total|Total of all reporting groups
137021|NCT01624168|B3|Baseline|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
137022|NCT01624168|B2|Baseline|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week
10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
137023|NCT01624168|B1|Baseline|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
137024|NCT01624168|P3|Participant Flow|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
137025|NCT01624168|P2|Participant Flow|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week
10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
137026|NCT01624168|P1|Participant Flow|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
137027|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
137028|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week
10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
137029|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
137030|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
137031|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week
10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
137032|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
137033|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
137034|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week
10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
137035|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
137036|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
137037|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week
10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
137039|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
137040|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week
10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
137041|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
137042|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
137043|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week
10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
137044|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
137045|NCT01624168|E3|Reported Event|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
137046|NCT01624168|E2|Reported Event|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week
10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
137047|NCT01624168|E1|Reported Event|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
137048|NCT01623869|B1|Baseline|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
137049|NCT01623869|P1|Participant Flow|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
137050|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
137051|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
137052|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
137053|NCT01623869|E1|Reported Event|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
137054|NCT01623830|B3|Baseline|Total|Total of all reporting groups
137055|NCT01623830|B2|Baseline|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137056|NCT01623830|B1|Baseline|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137057|NCT01623830|P2|Participant Flow|Neutral Cue + VRE|"VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment."
137058|NCT01623830|P1|Participant Flow|Reactivation + VRE|"Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment."
137059|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137060|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137061|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137062|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137063|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137064|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137065|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137066|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137067|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137068|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137069|NCT01623830|E2|Reported Event|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137070|NCT01623830|E1|Reported Event|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
137071|NCT01623479|B1|Baseline|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
137072|NCT01623479|P1|Participant Flow|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
137073|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
137074|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
137075|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
137076|NCT01623479|E1|Reported Event|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
137077|NCT01623466|B3|Baseline|Total|Total of all reporting groups
137078|NCT01623466|B2|Baseline|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5
levonorgestrel: transdermal contraceptive delivery system"
137079|NCT01623466|B1|Baseline|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5
levonorgestrel: transdermal contraceptive delivery system"
137080|NCT01623466|P2|Participant Flow|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5
levonorgestrel: transdermal contraceptive delivery system"
137081|NCT01623466|P1|Participant Flow|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5
levonorgestrel: transdermal contraceptive delivery system"
137082|NCT01623466|O2|Outcome|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5
levonorgestrel: transdermal contraceptive delivery system"
137083|NCT01623466|O1|Outcome|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5
levonorgestrel: transdermal contraceptive delivery system"
138107|NCT01617187|B4|Baseline|Placebo BID|Participants were administered placebo tablets BID for 42 days
137085|NCT01623466|O1|Outcome|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5
levonorgestrel: transdermal contraceptive delivery system"
137086|NCT01623466|O2|Outcome|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5
levonorgestrel: transdermal contraceptive delivery system"
137087|NCT01623466|O1|Outcome|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5
levonorgestrel: transdermal contraceptive delivery system"
137088|NCT01623466|O2|Outcome|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5
levonorgestrel: transdermal contraceptive delivery system"
137089|NCT01623466|O1|Outcome|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5
levonorgestrel: transdermal contraceptive delivery system"
137090|NCT01623466|O2|Outcome|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5
levonorgestrel: transdermal contraceptive delivery system"
137091|NCT01623466|O1|Outcome|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5
levonorgestrel: transdermal contraceptive delivery system"
137092|NCT01623466|E2|Reported Event|AG890-12.5|"Evaluate levonorgestrel delivery in AG890-12.5
levonorgestrel: transdermal contraceptive delivery system"
137093|NCT01623466|E1|Reported Event|AG890-6.5|"Evaluate levonorgestrel delivery in AG890-6.5
levonorgestrel: transdermal contraceptive delivery system"
137094|NCT01623323|B1|Baseline|OPN-375|OPN-375 400 mcg/twice daily
137095|NCT01623323|P1|Participant Flow|OPN-375|OPN-375 400 mcg/twice daily
137096|NCT01623323|O1|Outcome|OPN-375|OPN-375 400 mcg/twice daily
137097|NCT01623323|E1|Reported Event|OPN-375|OPN-375 400 mcg/twice daily
137098|NCT01623271|B1|Baseline|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.
Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
137099|NCT01623271|P1|Participant Flow|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.
Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
137100|NCT01623271|O1|Outcome|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.
Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
137101|NCT01623271|E1|Reported Event|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.
Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
137102|NCT01623154|B1|Baseline|BreathTek UBT|Comparison of urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300. UBiT-IR300 is the FDA approved device.
137103|NCT01623154|P1|Participant Flow|Urea Hydrolysis Rate (UHR)|"Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT -IR300
Same patients will be tested on both the POCone and UBiT-IR300"
137104|NCT01623154|O2|Outcome|POCone|This is the device being tested and compared to the FDA approved device.
137105|NCT01623154|O1|Outcome|UBiT-IR300|This is the FDA approved device.
137106|NCT01623154|O1|Outcome|Urea Hydrolysis Rate (UHR) Values|Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone compared to the the approved device, UBiT-IR300. Three regression analyses completed (Deming, Passing-Bablok and Regular regression).
137107|NCT01623154|E1|Reported Event|Pranactin Citric Solution|At each visit, each subject provided baseline breath samples by exhaling into the mouthpiece of the 3 Baseline bags (Blue bags, labeled A,B, C according to collection order), received one 4 oz administration of Pranctin Citric solution (mixed in water, drink using a straw), waited 15 minutes and provided the Post-Dose breath samples (Pink bags, labeled A, B, C). The Blue and Pink bags were paired and tested in no particular order on each instrument. The subjects who tested positive for H.pylori underwent a second set of tests 28 days after completion of eradication therapy.
137108|NCT01623115|B3|Baseline|Total|Total of all reporting groups
137109|NCT01623115|B2|Baseline|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137110|NCT01623115|B1|Baseline|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137111|NCT01623115|P2|Participant Flow|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137112|NCT01623115|P1|Participant Flow|Placebo|Placebo for alirocumab subcutaneous (SC) injection every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.
137113|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137114|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137115|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137116|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137117|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137118|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137119|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137120|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
145179|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
137121|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137122|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137123|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137124|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137125|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137126|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137127|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137128|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137129|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137130|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137131|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137132|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137133|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137134|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137135|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137136|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137137|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137138|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137139|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137140|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137141|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137142|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137143|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137144|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137145|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137146|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137147|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137148|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137149|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137150|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137151|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137152|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137153|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137154|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137155|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137156|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137157|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137158|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137257|NCT01622257|E3|Reported Event|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
145180|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
137159|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137160|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137161|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137162|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137163|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137164|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137165|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137166|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137167|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
137168|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137169|NCT01623115|E2|Reported Event|Alirocumab 75/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 mg/Up to 150 mg Q2W on top of stable LMT (mean exposure of 72 weeks).
137170|NCT01623115|E1|Reported Event|Placebo|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 72 weeks).
137171|NCT01623050|B1|Baseline|SinuSys Dilation System|"Maxillary Sinus Dilation
SinuSys Dilation System: Sinuplasty"
137172|NCT01623050|P1|Participant Flow|SinuSys Dilation System|Maxillary Sinus Dilation
137173|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
137174|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
137175|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
137176|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
137177|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
137178|NCT01623050|E1|Reported Event|SinuSys Dilation System|Maxillary Sinus Dilation
137179|NCT01622673|B7|Baseline|Total|Total of all reporting groups
137202|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
137180|NCT01622673|B6|Baseline|MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
137181|NCT01622673|B5|Baseline|TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
137182|NCT01622673|B4|Baseline|RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
137183|NCT01622673|B3|Baseline|MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
137184|NCT01622673|B2|Baseline|TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
137185|NCT01622673|B1|Baseline|RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
137186|NCT01622673|P6|Participant Flow|MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
137187|NCT01622673|P5|Participant Flow|TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
137188|NCT01622673|P4|Participant Flow|RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
137258|NCT01622257|E2|Reported Event|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
137189|NCT01622673|P3|Participant Flow|MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
137190|NCT01622673|P2|Participant Flow|TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
137191|NCT01622673|P1|Participant Flow|RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
137192|NCT01622673|O5|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of AE assessment
137193|NCT01622673|O4|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of AE assessment
137194|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of AE assessment
137195|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of AE assessment
137196|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
137197|NCT01622673|O5|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
137198|NCT01622673|O4|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
137199|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
137200|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
137203|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
137204|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
137205|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
137206|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
137207|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
137208|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
137209|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
137210|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
137211|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
137212|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
137213|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
137214|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
137215|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
137216|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
137217|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
137218|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
137219|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
137220|NCT01622673|E5|Reported Event|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
137221|NCT01622673|E4|Reported Event|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
137222|NCT01622673|E3|Reported Event|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
137223|NCT01622673|E2|Reported Event|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
137224|NCT01622673|E1|Reported Event|Raltegravir|Raltegravir 400 mg every 12 hours
137259|NCT01622257|E1|Reported Event|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
145181|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
137225|NCT01622660|B1|Baseline|Gemcitabine and Pazopanib|"This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy.
Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles."
137226|NCT01622660|P1|Participant Flow|Gemcitabine and Pazopanib|Chemotherapy naïve participants with advanced/metastatic urothelial carcinoma ineligible for Cisplatin-based chemotherapy
137227|NCT01622660|O1|Outcome|Gemcitabine and Pazopanib|"This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy.
Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles."
137228|NCT01622660|E1|Reported Event|Gemcitabine and Pazopanib|"This is a phase II trial of gemcitabine and pazopanib in previously untreated patients with advanced/metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy.
Gemcitabine and Pazopanib: Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days). Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles."
137229|NCT01622296|B1|Baseline|Crossover Lidocaine/Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine or buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine
137273|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137777|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
137230|NCT01622296|P2|Participant Flow|Buffered Lidocaine First, Then Lidocaine|buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
137231|NCT01622296|P1|Participant Flow|Lidocaine First, Then Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
137232|NCT01622296|O2|Outcome|Buffered Lidocaine|2% buffered lidocaine with 1:100,000 ppm epinephrine
137233|NCT01622296|O1|Outcome|Lidocaine|2% lidocaine with 1:100,000 ppm epinephrine
137234|NCT01622296|E1|Reported Event|Crossover Lidocaine/Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine or buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine
137235|NCT01622257|B4|Baseline|Total|Total of all reporting groups
137236|NCT01622257|B3|Baseline|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
137237|NCT01622257|B2|Baseline|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
137238|NCT01622257|B1|Baseline|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
137239|NCT01622257|P3|Participant Flow|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
137240|NCT01622257|P2|Participant Flow|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
137241|NCT01622257|P1|Participant Flow|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
137242|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
137243|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
137244|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
137245|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
137246|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
137247|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
137248|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
137249|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
137250|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
137251|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
137252|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
137253|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
137254|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
137255|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
137256|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
137260|NCT01622231|B1|Baseline|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137261|NCT01622231|P1|Participant Flow|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137262|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137263|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137264|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137265|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137266|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137267|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137268|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137269|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137270|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137271|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137272|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137344|NCT01621633|E1|Reported Event|Moderate Hepatic Impaired Patients|Moderate hepatic impaired patients
137274|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137275|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137276|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137277|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137278|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137279|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137280|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137281|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137282|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137283|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137284|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137285|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137286|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137287|NCT01622231|E1|Reported Event|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
137288|NCT01621776|B4|Baseline|Total|Total of all reporting groups
137289|NCT01621776|B3|Baseline|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
137290|NCT01621776|B2|Baseline|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
137291|NCT01621776|B1|Baseline|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
137328|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137717|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137292|NCT01621776|P3|Participant Flow|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
137293|NCT01621776|P2|Participant Flow|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
137294|NCT01621776|P1|Participant Flow|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
137295|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
137296|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
137297|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
137298|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
137299|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
137300|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
137301|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
137302|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
138705|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
137303|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
137304|NCT01621776|E3|Reported Event|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
137305|NCT01621776|E2|Reported Event|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
137306|NCT01621776|E1|Reported Event|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
137307|NCT01621672|B3|Baseline|Total|Total of all reporting groups
137308|NCT01621672|B2|Baseline|Observation|No treatment
137309|NCT01621672|B1|Baseline|Revlimid|Revlimid: 10 mg/day in the morning same time each day
137310|NCT01621672|P2|Participant Flow|Observation|No treatment
137311|NCT01621672|P1|Participant Flow|Revlimid|Revlimid: 10 mg/day in the morning same time each day
137312|NCT01621672|O2|Outcome|Observation|No treatment
137313|NCT01621672|O1|Outcome|Revlimid|Revlimid: 10 mg/day in the morning same time each day
137314|NCT01621672|E2|Reported Event|Observation|No treatment
137315|NCT01621672|E1|Reported Event|Revlimid|Revlimid: 10 mg/day in the morning same time each day
137316|NCT01621633|B5|Baseline|Total|Total of all reporting groups
137317|NCT01621633|B4|Baseline|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
137318|NCT01621633|B3|Baseline|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
137319|NCT01621633|B2|Baseline|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137320|NCT01621633|B1|Baseline|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137321|NCT01621633|P4|Participant Flow|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
137322|NCT01621633|P3|Participant Flow|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
137323|NCT01621633|P2|Participant Flow|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137324|NCT01621633|P1|Participant Flow|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137325|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
137326|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
137327|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137329|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
137330|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
137331|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137332|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137333|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
137334|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
137335|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137336|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137337|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
137338|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
137339|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137340|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137341|NCT01621633|E4|Reported Event|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
137342|NCT01621633|E3|Reported Event|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
137343|NCT01621633|E2|Reported Event|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
137345|NCT01621477|B1|Baseline|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
137346|NCT01621477|P1|Participant Flow|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
137347|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
137348|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
137349|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
137350|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
137351|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
137352|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
137353|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
137354|NCT01621477|E1|Reported Event|Treatment|Study participants (excluding donors) who were enrolled to receive treatment with clofarabine, cytarabine, busulfan, plerixafor, cyclophosphamide, antithymocyte globulin (rabbit), stem cells, tacrolimus, and mycophenolate mofetil. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
137355|NCT01621191|B1|Baseline|Duloxetine 60 mg|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
137356|NCT01621191|P1|Participant Flow|Duloxetine 60 mg|"Treatment Period: Up to a 60-milligram (mg) dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
137357|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
137358|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
137381|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137359|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
137360|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
137361|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
137362|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
137363|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
137364|NCT01621191|O1|Outcome|Duloxetine 60 mg|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
137391|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137392|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137365|NCT01621191|E1|Reported Event|60 mg Duloxetine|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
137366|NCT01621178|B4|Baseline|Total|Total of all reporting groups
137367|NCT01621178|B3|Baseline|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137368|NCT01621178|B2|Baseline|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137369|NCT01621178|B1|Baseline|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137370|NCT01621178|P3|Participant Flow|1.5 mg Dulaglutide|1.5 mg of dulaglutide was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137371|NCT01621178|P2|Participant Flow|0.75 mg Dulaglutide|0.75 milligram (mg) of dulaglutide was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137372|NCT01621178|P1|Participant Flow|Insulin Glargine|Insulin glargine was administered subcutaneously (SQ) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137373|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137374|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137375|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine administered SQ to be given at bedtime per sliding scale. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137376|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137377|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137378|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137379|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137380|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137718|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137382|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137383|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137384|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137385|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137386|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137387|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137388|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137389|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137390|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137756|NCT01618864|B1|Baseline|Luxe Treatment Group|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
137393|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137394|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137395|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137396|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137397|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137398|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137399|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137400|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137401|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137402|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137403|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137404|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137405|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137406|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137407|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137668|NCT01619059|B2|Baseline|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
145182|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
137408|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137409|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137410|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137411|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137412|NCT01621178|O3|Outcome|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137413|NCT01621178|O2|Outcome|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137414|NCT01621178|O1|Outcome|Insulin Glargine|Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137415|NCT01621178|E3|Reported Event|Dulaglutide 1.5 mg|Dulaglutide 1.5 mg administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137416|NCT01621178|E2|Reported Event|Dulaglutide 0.75 mg|Dulaglutide 0.75 mg administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137417|NCT01621178|E1|Reported Event|Insulin Glargine|Insulin glargine administered SQ to be given at bedtime per sliding scale. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
137684|NCT01618968|B3|Baseline|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137418|NCT01621126|B1|Baseline|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
137419|NCT01621126|P1|Participant Flow|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
137420|NCT01621126|O1|Outcome|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
137421|NCT01621126|E1|Reported Event|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
137422|NCT01621009|B5|Baseline|Total|Total of all reporting groups
137423|NCT01621009|B4|Baseline|Placebo Medication, No Counseling|Placebo bupropion, No counseling, just medication checks
137424|NCT01621009|B3|Baseline|Placebo Medication + Counseling|Placebo bupropion plus eight 10-minute individual counseling sessions
137425|NCT01621009|B2|Baseline|Active Bupropion , No Counseling|Active bupropion, No counseling, only medication checks
137426|NCT01621009|B1|Baseline|Active Bupropion + Counseling|Active bupropion SR plus eight 10-minute individual counseling sessions.
137427|NCT01621009|P4|Participant Flow|Placebo Medication, No Counseling|Placebo bupropion, No counseling, just medication checks
137428|NCT01621009|P3|Participant Flow|Placebo Medication + Counseling|Placebo bupropion plus eight 10-minute individual counseling sessions
137429|NCT01621009|P2|Participant Flow|Active Bupropion , No Counseling|Active bupropion, No counseling, only medication checks
137430|NCT01621009|P1|Participant Flow|Active Bupropion + Counseling|Active bupropion SR plus eight 10-minute individual counseling sessions.
137431|NCT01621009|O4|Outcome|Placebo, No Counseling|": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.
No cessation counseling, medication management and assessment only."
137432|NCT01621009|O3|Outcome|Placebo + Counseling|": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.
Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"
138952|NCT01613014|B2|Baseline|ABT-436|"ABT-436 Target dose of 400 mg BID
ABT-436: Target dose - 400mg BID"
137433|NCT01621009|O2|Outcome|Bupropion, No Counseling|Active bupropion, No counseling: Medications: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date. No cessation counseling, medication management and assessment only.
137434|NCT01621009|O1|Outcome|Bupropion + Counseling|"Active bupropion + 8 weeks counseling: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.
Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"
137435|NCT01621009|E2|Reported Event|Active Medication|Pre-quit – 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.
137436|NCT01621009|E1|Reported Event|Placebo Medication|Medications: Pre-quit – one placebo pill for 3 days before quit day, then one placebo pill twice a day 4 days before quit day for 8 weeks after the quit date.
137437|NCT01620489|B3|Baseline|Total|Total of all reporting groups
137438|NCT01620489|B2|Baseline|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137439|NCT01620489|B1|Baseline|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137440|NCT01620489|P2|Participant Flow|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137441|NCT01620489|P1|Participant Flow|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137442|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137443|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137444|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137445|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137446|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137447|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137448|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137449|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137669|NCT01619059|B1|Baseline|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
138956|NCT01613014|O2|Outcome|ABT-436|"ABT-436 Target dose of 400 mg BID
ABT-436: Target dose - 400mg BID"
137450|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137451|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137452|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137453|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137454|NCT01620489|E2|Reported Event|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137685|NCT01618968|B2|Baseline|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137455|NCT01620489|E1|Reported Event|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
137456|NCT01620255|B6|Baseline|Total|Total of all reporting groups
137457|NCT01620255|B5|Baseline|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137458|NCT01620255|B4|Baseline|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137459|NCT01620255|B3|Baseline|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137460|NCT01620255|B2|Baseline|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137461|NCT01620255|B1|Baseline|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137462|NCT01620255|P5|Participant Flow|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137463|NCT01620255|P4|Participant Flow|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137464|NCT01620255|P3|Participant Flow|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137465|NCT01620255|P2|Participant Flow|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137466|NCT01620255|P1|Participant Flow|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 centimeters (cm) apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137467|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137468|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137469|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137585|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
137470|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137471|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137472|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137473|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137474|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137475|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137476|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137477|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137478|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137479|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137480|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137719|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137481|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137482|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137483|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137484|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137485|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137486|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137487|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137488|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137489|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137490|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137491|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137492|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137493|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137494|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137495|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137720|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137496|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137497|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137498|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137499|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137500|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137501|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137502|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137503|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137504|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137505|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137506|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137507|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137508|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137509|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137510|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137721|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137511|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137512|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137513|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137514|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137515|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137516|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137517|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137518|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137519|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137520|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137521|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137522|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137523|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137524|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137525|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137722|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137526|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137527|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137528|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137529|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137530|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137531|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137532|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137533|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137534|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137535|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137536|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137537|NCT01620255|E5|Reported Event|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137538|NCT01620255|E4|Reported Event|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137539|NCT01620255|E3|Reported Event|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137540|NCT01620255|E2|Reported Event|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137723|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137541|NCT01620255|E1|Reported Event|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
137542|NCT01620177|B1|Baseline|Overall Study|Individuals who completed the study completed all six arms of the study and the data is aggregated. Non-completers may have completed some arms and not others and their data is aggregated.
137543|NCT01620177|P1|Participant Flow|Overall Study|Individuals who completed the study completed all six arms of the study and the data is aggregated. Non-completers may have completed some arms and not others and their data is aggregated. There will be six study visits where the subject will arrive at the Clinical Research Unit(University of Iowa Hospitals & Clinics) the night before dosing. At each visit subjects will be receive one of the following six dosing regimens: placebo alcohol with placebo cannabis; placebo alcohol with low-dose cannabis, placebo alcohol with higher-dose of cannabis, low dose alcohol with placebo cannabis; low dose alcohol with low dose cannabis, low dose alcohol with higher-dose of cannabis.
137544|NCT01620177|O6|Outcome|0% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137545|NCT01620177|O5|Outcome|6.0-7.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137546|NCT01620177|O4|Outcome|2.5-3.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137547|NCT01620177|O3|Outcome|6.0-7.5% THC and 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137548|NCT01620177|O2|Outcome|2.5-3.5% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137549|NCT01620177|O1|Outcome|0% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137550|NCT01620177|O6|Outcome|0% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137551|NCT01620177|O5|Outcome|6.0-7.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137552|NCT01620177|O4|Outcome|2.5-3.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137553|NCT01620177|O3|Outcome|6.0-7.5% THC and 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137554|NCT01620177|O2|Outcome|2.5-3.5% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137670|NCT01619059|P2|Participant Flow|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
137555|NCT01620177|O1|Outcome|0% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137556|NCT01620177|O3|Outcome|THC x BrAC|Data from all dosing conditions combined to estimate the interactive effect of THC and BrAC concentrations using a regression equation.
137557|NCT01620177|O2|Outcome|Alcohol - BrAC (Breath Alcohol Concentration)|Data from all dosing conditions combined to estimate the effect of BrACconcentrations using a regression equation.
137558|NCT01620177|O1|Outcome|Cannabis - THC|Data from all dosing conditions combined to estimate the effect of THC concentrations using a regression equation.
137559|NCT01620177|E6|Reported Event|0% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137611|NCT01620047|O2|Outcome|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137560|NCT01620177|E5|Reported Event|6.0-7.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137561|NCT01620177|E4|Reported Event|2.5-3.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137562|NCT01620177|E3|Reported Event|6.0-7.5% THC and 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137563|NCT01620177|E2|Reported Event|2.5-3.5% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137564|NCT01620177|E1|Reported Event|0% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
137565|NCT01620138|B3|Baseline|Total|Total of all reporting groups
137566|NCT01620138|B2|Baseline|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.
cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.
The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
137567|NCT01620138|B1|Baseline|Pasireotide|"For non-cured patients with resistant prolactinomas , MRI will be performed before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.
For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated clinically by MRI six months after pasireotide.
Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.
The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
137568|NCT01620138|P2|Participant Flow|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.
cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.
The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
137671|NCT01619059|P1|Participant Flow|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
137724|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137569|NCT01620138|P1|Participant Flow|Pasireotide|"Non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.
Patients with a nonfunctioning pituitary adenoma (NFPA), treatment will be started at least 3 months after neurosurgery. The efficacy will be evaluated by MRI 6 months after pasireotide.
Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.
The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After 4 weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for 6 months."
137586|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
137681|NCT01619059|E1|Reported Event|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
137570|NCT01620138|O2|Outcome|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.
cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.
The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
137571|NCT01620138|O1|Outcome|Pasireotide|"For non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.
For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated by MRI six months after pasireotide.
Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.
The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
137572|NCT01620138|E2|Reported Event|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.
cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.
The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
137573|NCT01620138|E1|Reported Event|Pasireotide|"For non-cured patients with resistant prolactinomas , MRI will be performed immediately before and six months after the onset of pasireotide . The efficacy will be evaluated by prolactin dosage every month.
For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated by MRI six months after pasireotide.
Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.
The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
137574|NCT01620086|B3|Baseline|Total|Total of all reporting groups
137575|NCT01620086|B2|Baseline|Controls|These subjects are normal controls without schizophrenia who get stimulation over the vertex.
137576|NCT01620086|B1|Baseline|Patients|Patients with Schizophrenia who meet entry criteria for the study and get stimulation over temporal cortex.
137577|NCT01620086|P3|Participant Flow|Patients: Baseline, Control Site, 10Hz First|These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz over the control site at the vertex, and then were randomized to receive 10 Hz over the treatment site in temporal cortex before receiving 1 Hz over the treatment site in temporal cortex. All treatment is for four days.
137578|NCT01620086|P2|Participant Flow|Patients: Baseline, Control Site, & 1Hz First|These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz located over the control site at the vertex, and then were randomized to receive 1 Hz over the treatment site in temporal cortex before receiving 10 Hz over the treatment site in temporal cortex. All stimulation is delivered for four days.
137579|NCT01620086|P1|Participant Flow|Controls: Baseline, 1Hz Sham, 1 Hz Active Over Vertex|These subjects are normal controls without schizophrenia who receive baseline testing, then sham rTMS, and then active 1Hz rTMS. All stimulation is for two days and delivered over the control site located at the vertex.
137580|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
137581|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
137672|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
145183|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
137582|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
137583|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
137584|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
137587|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
137588|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
137589|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
137590|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
137591|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
137592|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz
Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz
Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
137593|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
137594|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.
Baseline, no stimulation
Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex
Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
137595|NCT01620086|E2|Reported Event|Controls|These subjects are normal controls without schizophrenia.
137596|NCT01620086|E1|Reported Event|Patients|These are schizophrenic patients who meet entry criteria for the study.
137597|NCT01620060|B1|Baseline|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day
Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
137598|NCT01620060|P1|Participant Flow|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day
Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
137599|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day
Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
137600|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day
Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
137601|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day
Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
137602|NCT01620060|E1|Reported Event|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day
Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
137603|NCT01620047|B4|Baseline|Total|Total of all reporting groups
137604|NCT01620047|B3|Baseline|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137605|NCT01620047|B2|Baseline|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137606|NCT01620047|B1|Baseline|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137715|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137607|NCT01620047|P3|Participant Flow|Intravenous Fentanyl|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137608|NCT01620047|P2|Participant Flow|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137609|NCT01620047|P1|Participant Flow|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137610|NCT01620047|O3|Outcome|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137682|NCT01618968|B5|Baseline|Total|Total of all reporting groups
137751|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
137752|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
137612|NCT01620047|O1|Outcome|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137613|NCT01620047|E3|Reported Event|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137614|NCT01620047|E2|Reported Event|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137615|NCT01620047|E1|Reported Event|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
137616|NCT01619878|B1|Baseline|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137617|NCT01619878|P1|Participant Flow|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137618|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137619|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137620|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137621|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137622|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137623|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137624|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137625|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137626|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137627|NCT01619878|E1|Reported Event|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days."
137628|NCT01619800|B3|Baseline|Total|Total of all reporting groups
137629|NCT01619800|B2|Baseline|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
137630|NCT01619800|B1|Baseline|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
137631|NCT01619800|P2|Participant Flow|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
137632|NCT01619800|P1|Participant Flow|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
137633|NCT01619800|O2|Outcome|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
137634|NCT01619800|O1|Outcome|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
137635|NCT01619800|E2|Reported Event|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
137636|NCT01619800|E1|Reported Event|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
137637|NCT01619787|B3|Baseline|Total|Total of all reporting groups
137638|NCT01619787|B2|Baseline|Overweight/Obese Participants|"Participants whose baseline BMI is greater than or equal to 25.
All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study; therefore, 5 participants were lost to follow up and no age or body mass index are reported for these participants."
137639|NCT01619787|B1|Baseline|Lean Participants|"Participants whose baseline BMI is less than 25.
All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study; therefore, 5 participants were lost to follow up and no age or body mass index are reported for these participants."
137640|NCT01619787|P1|Participant Flow|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
137641|NCT01619787|O3|Outcome|Overweight/Obese Participants|Participants with BMI greater than or equal to 25.
137642|NCT01619787|O2|Outcome|Lean Participants|Participants with BMI less than 25.
137683|NCT01618968|B4|Baseline|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137643|NCT01619787|O1|Outcome|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
137644|NCT01619787|O3|Outcome|Overweight/Obese Participants|Participants with BMI greater than or equal to 25.
137645|NCT01619787|O2|Outcome|Lean Participants|Participants with BMI less than 25.
137646|NCT01619787|O1|Outcome|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
137647|NCT01619787|E1|Reported Event|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy, along with the Three Factor Eating Questionnaire were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
137648|NCT01619774|B1|Baseline|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
137649|NCT01619774|P1|Participant Flow|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
137650|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
137651|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
137652|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
137653|NCT01619774|E1|Reported Event|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
137654|NCT01619579|B3|Baseline|Total|Total of all reporting groups
137655|NCT01619579|B2|Baseline|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
137656|NCT01619579|B1|Baseline|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
137657|NCT01619579|P2|Participant Flow|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily.
137658|NCT01619579|P1|Participant Flow|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily.
137659|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
137660|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
137661|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
137662|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
137663|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
137664|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
137665|NCT01619579|E2|Reported Event|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
137666|NCT01619579|E1|Reported Event|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
137667|NCT01619059|B3|Baseline|Total|Total of all reporting groups
137716|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137673|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
137674|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
137675|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
137676|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
137677|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
137678|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
137679|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
137680|NCT01619059|E2|Reported Event|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
137686|NCT01618968|B1|Baseline|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137687|NCT01618968|P4|Participant Flow|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137688|NCT01618968|P3|Participant Flow|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137689|NCT01618968|P2|Participant Flow|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137690|NCT01618968|P1|Participant Flow|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137691|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
137692|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
137693|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
137694|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
137695|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
137696|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
137697|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
137698|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
137699|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
137700|NCT01618968|E4|Reported Event|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137701|NCT01618968|E3|Reported Event|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137702|NCT01618968|E2|Reported Event|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137703|NCT01618968|E1|Reported Event|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
137704|NCT01618955|B5|Baseline|Total|Total of all reporting groups
137705|NCT01618955|B4|Baseline|MTX 25 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
137706|NCT01618955|B3|Baseline|MTX 20 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
137707|NCT01618955|B2|Baseline|MTX 15 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
137708|NCT01618955|B1|Baseline|MTX 10 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
137709|NCT01618955|P4|Participant Flow|MTX 25 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
137710|NCT01618955|P3|Participant Flow|MTX 20 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
137711|NCT01618955|P2|Participant Flow|MTX 15 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
137712|NCT01618955|P1|Participant Flow|MTX 10 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
137713|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137714|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137725|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137726|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137727|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137728|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137729|NCT01618955|E4|Reported Event|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137730|NCT01618955|E3|Reported Event|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137731|NCT01618955|E2|Reported Event|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137732|NCT01618955|E1|Reported Event|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
137733|NCT01618942|B3|Baseline|Total|Total of all reporting groups
137734|NCT01618942|B2|Baseline|Female Subjects|grouped by gender
137735|NCT01618942|B1|Baseline|Male Subjects|grouped by gender
137736|NCT01618942|P2|Participant Flow|Female Subjects|grouped by gender grouped by gender and applied with hand-held pressure algometer with differen
137737|NCT01618942|P1|Participant Flow|Male Subjects|grouped by gender and applied with hand-held pressure algometer with differen
137738|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
137739|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
137740|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
137741|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
137742|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
137743|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
137744|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
137745|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
137746|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
137747|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
137748|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
137749|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
137750|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
137757|NCT01618864|P1|Participant Flow|Luxe Treatment Group|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
137758|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|Evaluation of rosacea after 8 weeks of treatment.
137759|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Subjects with rosacea were evaluated by the investigator and a score provided according to a validated rosacea scale for improvement in features of rosacea such as flushing.
137760|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks and assessment at week 8.
137761|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by assessment.
137762|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|GAI assessment by investigator at 8 weeks.
137763|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
137764|NCT01618864|E1|Reported Event|Treatment Group|All treated subjects were evaluated for adverse events during the study.
137765|NCT01618838|B1|Baseline|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).
CyberKnife radiosurgery: Treatment Planning:
Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
137766|NCT01618838|P1|Participant Flow|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).
CyberKnife radiosurgery: Treatment Planning:
Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
137793|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137794|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
145184|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
137767|NCT01618838|O1|Outcome|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).
CyberKnife radiosurgery: Treatment Planning:
Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
137768|NCT01618838|E1|Reported Event|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).
CyberKnife radiosurgery: Treatment Planning:
Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
137769|NCT01618708|B3|Baseline|Total|Total of all reporting groups
137770|NCT01618708|B2|Baseline|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
137771|NCT01618708|B1|Baseline|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
137772|NCT01618708|P2|Participant Flow|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
137773|NCT01618708|P1|Participant Flow|Placebo|Single 6 mL intraarticular (IA) injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
137774|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
137775|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
137776|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
137778|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
137779|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.
137780|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
137781|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
137782|NCT01618708|E2|Reported Event|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
137783|NCT01618708|E1|Reported Event|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
137784|NCT01618669|B3|Baseline|Total|Total of all reporting groups
137785|NCT01618669|B2|Baseline|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137786|NCT01618669|B1|Baseline|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137787|NCT01618669|P2|Participant Flow|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137788|NCT01618669|P1|Participant Flow|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT myocardial perfusion imaging (MPI). One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137789|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137790|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137791|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137792|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
139625|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
137795|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137796|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137797|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137798|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137799|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137800|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137801|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137802|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137803|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137804|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137805|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137851|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137806|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137807|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137808|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137809|NCT01618669|O6|Outcome|REG Alone: MPI 2 SDS ≥ 14|Participants in the Regadenoson (REG) Alone group who had an SDS ≥ 14 on their second stress scan.
137810|NCT01618669|O5|Outcome|REG Alone: MPI 2 SDS 7-13|Participants in the Regadenoson (REG) Alone group who had an SDS from 7 to 13 on their second stress scan.
137811|NCT01618669|O4|Outcome|REG Alone: MPI 2 SDS 0-6|Participants in the Regadenoson (REG) Alone group who had an SDS from 0 to 6 on their second stress scan.
137812|NCT01618669|O3|Outcome|REG APEX: MPI 2 SDS ≥ 14|Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS ≥ 14 on their second stress scan.
137813|NCT01618669|O2|Outcome|REG APEX: MPI 2 7-13|Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS from 7 to 13 on their second stress scan.
137814|NCT01618669|O1|Outcome|REG APEX: MPI 2 SDS 0-6|Participants in the Regadenoson After Peak Exercise (APEX) group who had an SDS from 0 to 6 on their second stress scan.
137815|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137816|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137817|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137818|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137819|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137820|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137821|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137822|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137823|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137824|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137825|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137826|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137827|NCT01618669|E4|Reported Event|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137828|NCT01618669|E3|Reported Event|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137829|NCT01618669|E2|Reported Event|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137830|NCT01618669|E1|Reported Event|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
137831|NCT01618422|B3|Baseline|Total|Total of all reporting groups
137852|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137853|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137981|NCT01617655|B2|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
137832|NCT01618422|B2|Baseline|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
137833|NCT01618422|B1|Baseline|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin.
137834|NCT01618422|P2|Participant Flow|DOTS Plus|"The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and"
137835|NCT01618422|P1|Participant Flow|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
137836|NCT01618422|O2|Outcome|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
137837|NCT01618422|O1|Outcome|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
137838|NCT01618422|E2|Reported Event|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
139749|NCT01609257|B2|Baseline|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
137839|NCT01618422|E1|Reported Event|DOTS Strategy|The DOTS strategy (current strategy) consists of the following measures: political commitment, case detection through bacteriologic evaluation, standardized treatment with supervision and patient support, an effective drug supply system, and a reporting and recording system that allows assessment of treatment. The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin (2HRZE/4HR or 2HRZS/4HR). In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used (2HRZES/1HRZE/5HRE).
137840|NCT01618266|B1|Baseline|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137841|NCT01618266|P1|Participant Flow|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137842|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137843|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137844|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137845|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137846|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137847|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137848|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137849|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137850|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137854|NCT01618266|E1|Reported Event|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
137855|NCT01618240|B1|Baseline|Baseline Population|Thirty long-term ventilated patients admitted in two intensive care units at Massachusetts General Hospital.
137856|NCT01618240|P1|Participant Flow|Long-term Ventilated Subjects|Long-term (>10 days hours) ventilated subjects were included.
137857|NCT01618240|O1|Outcome|Muscle Strength Measurement|Muscle Strength Measurement : MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
137858|NCT01618240|O1|Outcome|Muscle Strength Measurement|Muscle Strength Measurement : MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
137859|NCT01618240|E1|Reported Event|Long-term Ventilated Subjects|30 consented long-term ventilated patients
137860|NCT01618227|B3|Baseline|Total|Total of all reporting groups
137861|NCT01618227|B2|Baseline|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
137862|NCT01618227|B1|Baseline|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.
Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
137863|NCT01618227|P2|Participant Flow|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
137864|NCT01618227|P1|Participant Flow|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.
Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
137865|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
137947|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137866|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.
Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
137867|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
137868|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.
Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
137869|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
137870|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.
Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
137871|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
137922|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
137923|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
137924|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
137872|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.
Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
137873|NCT01618227|E2|Reported Event|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
137874|NCT01618227|E1|Reported Event|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.
Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
137875|NCT01618214|B3|Baseline|Total|Total of all reporting groups
137876|NCT01618214|B2|Baseline|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137877|NCT01618214|B1|Baseline|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137878|NCT01618214|P2|Participant Flow|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137879|NCT01618214|P1|Participant Flow|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137880|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137881|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137882|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137883|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137925|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
137926|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
137884|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137885|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137886|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137887|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137888|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137889|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137890|NCT01618214|E2|Reported Event|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
138011|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
137891|NCT01618214|E1|Reported Event|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
137892|NCT01618162|B3|Baseline|Total|Total of all reporting groups
137893|NCT01618162|B2|Baseline|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
137894|NCT01618162|B1|Baseline|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
137927|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
137928|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
138706|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
137895|NCT01618162|P2|Participant Flow|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
137896|NCT01618162|P1|Participant Flow|IDegLira|In this arm, subjects suboptimally controlled on sulfonyl urea (SU) +/- metformin, were given subcutenaous (s.c.) injection of insulin degludec/liraglutide (IDegLira). SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
137897|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
137898|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
137899|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
137900|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
137901|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
137902|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
137903|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
137904|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
137905|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
137906|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
137907|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
137908|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
137909|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
137910|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
137911|NCT01618162|E2|Reported Event|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
145185|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
137912|NCT01618162|E1|Reported Event|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
137913|NCT01618019|B3|Baseline|Total|Total of all reporting groups
137914|NCT01618019|B2|Baseline|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
137915|NCT01618019|B1|Baseline|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
137916|NCT01618019|P2|Participant Flow|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
137917|NCT01618019|P1|Participant Flow|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
137918|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
137919|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
137920|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
137921|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
137980|NCT01617655|B3|Baseline|Total|Total of all reporting groups
137929|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
137930|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
137931|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
137932|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
137933|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
137934|NCT01618019|E2|Reported Event|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
137935|NCT01618019|E1|Reported Event|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
137936|NCT01617668|B3|Baseline|Total|Total of all reporting groups
137937|NCT01617668|B2|Baseline|Paclitaxel Without LCL161|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137938|NCT01617668|B1|Baseline|Paclitaxel With LCL161|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137939|NCT01617668|P4|Participant Flow|Paclitaxel Without LCL161 (Negative Group)|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137940|NCT01617668|P3|Participant Flow|Paclitaxel With LCL161 (Negative Group)|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137941|NCT01617668|P2|Participant Flow|Paclitaxel Without LCL161 (Positive Group)|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137942|NCT01617668|P1|Participant Flow|Paclitaxel With LCL161 (Positive Group)|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137943|NCT01617668|O1|Outcome|LCL161|Patients randomized to the LCL161 1800 mg once weekly for 12 weeks.
137944|NCT01617668|O1|Outcome|LCL161|Patients randomized to the LCL161 1800 mg once weekly for 12 weeks.
137945|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137946|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
138012|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138013|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
137948|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137949|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137950|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137951|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137952|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137953|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137954|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137955|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137956|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
138707|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
137957|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137958|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137959|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137960|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137961|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137962|NCT01617668|O2|Outcome|Paclitaxel Only|Patients randomized to the control arm who received paclitaxel 80 mg/m2 weekly for 12 weeks.
137963|NCT01617668|O1|Outcome|LCL161 + Paclitaxel|Patients randomized to the experimental arm received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks.
137964|NCT01617668|O1|Outcome|Paclitaxel Only|Patients randomized to the control arm who received paclitaxel 80 mg/m2 weekly for 12 weeks.
137965|NCT01617668|O1|Outcome|LCL161 + Paclitaxel|Patients randomized to the experimental arm who received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks.
137966|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137967|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137968|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137969|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137970|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
140885|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
137971|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137972|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137973|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137974|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137975|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137976|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137977|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137978|NCT01617668|E2|Reported Event|PACLITAXEL|Patients randomized to the control arm for gene expression signature positive/negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137979|NCT01617668|E1|Reported Event|LCL161+PACLITAXEL|Patients randomized to the experimental arm for gene expression signature positive/negative received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
137982|NCT01617655|B1|Baseline|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137983|NCT01617655|P2|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
137984|NCT01617655|P1|Participant Flow|Placebo Q2W|Placebo for alirocumab subcutaneous (SC) injection every two weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.
137985|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
137986|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137987|NCT01617655|O2|Outcome|Alirocumab 150 Q2W|Participants exposed to Alirocumab 150 mg Q2W on top of stable LMT (mean exposure of 78 weeks).
137988|NCT01617655|O1|Outcome|Placebo Q2W|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 78 weeks).
137989|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
137990|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137991|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
137992|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137993|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
137994|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137995|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
137996|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137997|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
137998|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
137999|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138000|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138001|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138002|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138003|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138004|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138005|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138006|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138007|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138008|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138009|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138010|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138014|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138015|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138016|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138017|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138018|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138019|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138020|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138021|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138022|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138023|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138024|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138025|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138026|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138027|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138028|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138029|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138030|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138031|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138032|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138033|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138034|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138035|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138036|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138037|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138038|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138039|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
138040|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
138041|NCT01617655|E2|Reported Event|Alirocumab 150 Q2W|Participants exposed to Alirocumab 150 mg Q2W on top of stable LMT (mean exposure of 68 weeks).
138042|NCT01617655|E1|Reported Event|Placebo Q2W|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 71 weeks).
138043|NCT01617603|B4|Baseline|Total|Total of all reporting groups
138044|NCT01617603|B3|Baseline|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138045|NCT01617603|B2|Baseline|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138046|NCT01617603|B1|Baseline|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138047|NCT01617603|P3|Participant Flow|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138048|NCT01617603|P2|Participant Flow|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138049|NCT01617603|P1|Participant Flow|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138050|NCT01617603|O3|Outcome|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138051|NCT01617603|O2|Outcome|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138052|NCT01617603|O1|Outcome|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138103|NCT01617369|O1|Outcome|Acute Hypertonic Saline Effect|"2.8% NaCl inhaled 30 minutes before MCC scan performed
Hypertonic Saline: 2.8% NaCl x 4ml via Pari LC STAR jet nebulizer"
145186|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
138053|NCT01617603|E3|Reported Event|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138054|NCT01617603|E2|Reported Event|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138055|NCT01617603|E1|Reported Event|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
138056|NCT01617577|B3|Baseline|Total|Total of all reporting groups
138057|NCT01617577|B2|Baseline|Placebo First Phase|Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
138058|NCT01617577|B1|Baseline|G-CSF First Phase|Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
138059|NCT01617577|P2|Participant Flow|Placebo First Phase|Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
138060|NCT01617577|P1|Participant Flow|G-CSF First Phase|Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
138061|NCT01617577|O1|Outcome|G-CSF and Placebo|All participants received G-CSF and placebo in crossover order
138062|NCT01617577|O2|Outcome|Placebo|All participants received placebo either in the first or second phase of crossover
138063|NCT01617577|O1|Outcome|G-CSF|All participants received G-CSF either in the first or second phase of the crossover
138064|NCT01617577|E2|Reported Event|G-CSF|participants who received GCSF injecitons during first or second phase
138065|NCT01617577|E1|Reported Event|Placebo|subjects who received placebo in either phase of the study
138066|NCT01617447|B3|Baseline|Total|Total of all reporting groups
138067|NCT01617447|B2|Baseline|Placebo|Placebo were orally administered once daily for 8 weeks.
138068|NCT01617447|B1|Baseline|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
138069|NCT01617447|P2|Participant Flow|Placebo|Placebo were orally administered once daily for 8 weeks.
138070|NCT01617447|P1|Participant Flow|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
138071|NCT01617447|O2|Outcome|Placebo|Placebo were orally administered once daily for 8 weeks.
138072|NCT01617447|O1|Outcome|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
138073|NCT01617447|E2|Reported Event|Placebo|Placebo were orally administered once daily for 8 weeks.
138074|NCT01617447|E1|Reported Event|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
138075|NCT01617434|B3|Baseline|Total|Total of all reporting groups
138076|NCT01617434|B2|Baseline|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138077|NCT01617434|B1|Baseline|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138078|NCT01617434|P2|Participant Flow|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138079|NCT01617434|P1|Participant Flow|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138080|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138081|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138082|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138083|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138125|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138126|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138127|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138128|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138084|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138085|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138086|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138087|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138088|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138089|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138104|NCT01617369|E2|Reported Event|Sustained Hypertonic Saline Effect|"2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured.
Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
138105|NCT01617369|E1|Reported Event|Acute Hypertonic Saline Effect|"2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured.
Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
138106|NCT01617187|B5|Baseline|Total|Total of all reporting groups
138090|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138091|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138092|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138093|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138094|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138095|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138096|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138097|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138098|NCT01617434|E2|Reported Event|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138099|NCT01617434|E1|Reported Event|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
138100|NCT01617369|B1|Baseline|Hypertonic Saline|"2.8% NaCl
Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
138101|NCT01617369|P1|Participant Flow|Hypertonic Saline|"2.8% NaCl
Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
138102|NCT01617369|O2|Outcome|Sustained Hypertonic Saline Effect|"2.8% NaCl Inhaled 4 hours before mucociliary clearance measured
Hypertonic saline = 2.8% NaCl x 4 ml delivered via Pari LC STAR jet nebulizer"
138108|NCT01617187|B3|Baseline|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138109|NCT01617187|B2|Baseline|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138110|NCT01617187|B1|Baseline|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138111|NCT01617187|P4|Participant Flow|Placebo BID|Participants were administered placebo tablets BID for 42 days
138112|NCT01617187|P3|Participant Flow|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) once daily (QD) for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138113|NCT01617187|P2|Participant Flow|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138114|NCT01617187|P1|Participant Flow|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet twice daily (BID) for 42 days
138115|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138116|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138117|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138118|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138119|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138120|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138121|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138122|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138123|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138124|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138129|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138130|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138131|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138132|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138133|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138134|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138135|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138136|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138137|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138138|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138139|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138140|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138141|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138142|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138143|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138144|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138145|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138146|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138147|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138148|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138149|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138150|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138151|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138152|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138153|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138154|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138155|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138156|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138157|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138158|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138159|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138160|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138161|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138162|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138163|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138164|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138165|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138166|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138167|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138168|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138169|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138170|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138171|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138172|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138173|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138174|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138175|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
138176|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
141891|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
138177|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138178|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138179|NCT01617187|E4|Reported Event|Placebo BID|Participants were administered placebo tablets BID for 42 days
138180|NCT01617187|E3|Reported Event|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
138181|NCT01617187|E2|Reported Event|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
138182|NCT01617187|E1|Reported Event|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
138183|NCT01617070|B1|Baseline|All Study Participants|"LNAA, washout, Kuvan, and LNAA+Kuvan
One group of 10 subjects, each under 4 conditions (each phase is 4 weeks)
Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4
Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
138184|NCT01617070|P1|Participant Flow|All Study Participants|"LNAA, washout, Kuvan, and LNAA+Kuvan
One group of 10 subjects, each under 4 conditions (each phase is 4 weeks)
Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4
Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
138185|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4
Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
138186|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
138187|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
138188|NCT01617070|O1|Outcome|LNAA|"LNAA
Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
138189|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4
Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
138190|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
138191|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
138192|NCT01617070|O1|Outcome|LNAA|"LNAA
Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
138193|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4
Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
138194|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
138195|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
138196|NCT01617070|O1|Outcome|LNAA|"LNAA
Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
138197|NCT01617070|E4|Reported Event|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4
Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
138198|NCT01617070|E3|Reported Event|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
138199|NCT01617070|E2|Reported Event|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
139010|NCT01612702|E1|Reported Event|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
138200|NCT01617070|E1|Reported Event|LNAA|"LNAA
Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
138201|NCT01617005|B1|Baseline|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
138202|NCT01617005|P1|Participant Flow|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active Rheumatoid Arthritis (RA) participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
138203|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
138204|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
138205|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
138206|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
138207|NCT01617005|E1|Reported Event|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
138208|NCT01616953|B3|Baseline|Total|Total of all reporting groups
138209|NCT01616953|B2|Baseline|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
138210|NCT01616953|B1|Baseline|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
138211|NCT01616953|P2|Participant Flow|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
138212|NCT01616953|P1|Participant Flow|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
138213|NCT01616953|O2|Outcome|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
138214|NCT01616953|O1|Outcome|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
138235|NCT01616576|O3|Outcome|Experimental|Data from Group A and Group B were pooled for the statistical analyses. Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B.
138215|NCT01616953|O2|Outcome|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
138216|NCT01616953|O1|Outcome|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
138217|NCT01616953|E2|Reported Event|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
138218|NCT01616953|E1|Reported Event|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
138219|NCT01616771|B1|Baseline|Glottis View Assessment|After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
138220|NCT01616771|P1|Participant Flow|Glottis View Assessment|After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
138221|NCT01616771|O2|Outcome|Smaller Sized GVL|The C&L grade was reassessed by smaller sized GVL, after removal of GVL selected by weight
139589|NCT01610037|B1|Baseline|QVA149|110/50 µg capsules for inhalation, o.d
138222|NCT01616771|O1|Outcome|GVL Selected by Weight|Right after Macintosh laryngoscope was removed, C&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
138223|NCT01616771|O2|Outcome|GVL Selected by Weight|Right after Macintosh laryngoscope was removed, C&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
138224|NCT01616771|O1|Outcome|Macintosh Laryngoscope|After induction of anesthesia, Macintosh laryngoscope was inserted into mouth and C&L grade was checked.
138225|NCT01616771|E3|Reported Event|Smaller Sized GVL|C&L grade assessment by smaller sized GVL, after removal of GVL selected by weight
138226|NCT01616771|E2|Reported Event|GVL Selected by Weight|C&L grade assessment by GVL selected by weight, after removal of Macintosh laryngoscope
138227|NCT01616771|E1|Reported Event|Macintosh Laryngoscope|C&L grade assessment by Macintosh laryngoscope, after induction of anesthesia
138228|NCT01616576|B3|Baseline|Total|Total of all reporting groups
138229|NCT01616576|B2|Baseline|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
138230|NCT01616576|B1|Baseline|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
138231|NCT01616576|P2|Participant Flow|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
138232|NCT01616576|P1|Participant Flow|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
138233|NCT01616576|O2|Outcome|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
138234|NCT01616576|O1|Outcome|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
138236|NCT01616576|O2|Outcome|Control|Data from Group A and Group B were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B.
138237|NCT01616576|O1|Outcome|Group A and Group B Data Pooled|Data from Group A (n=18) and Group B (n=18) were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B; Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B. The resulting mean Control score was subtracted from the mean Experimental score to yield a paired difference score (i.e. Experimental - Control = paired difference score). The paired difference score (n=36) is reported below for each listening condition.
138238|NCT01616576|E2|Reported Event|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week.
Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
138239|NCT01616576|E1|Reported Event|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System condition for the second week.
Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
138240|NCT01616459|B5|Baseline|Total|Total of all reporting groups
138241|NCT01616459|B4|Baseline|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
138374|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
138242|NCT01616459|B3|Baseline|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138243|NCT01616459|B2|Baseline|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138244|NCT01616459|B1|Baseline|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138245|NCT01616459|P4|Participant Flow|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138246|NCT01616459|P3|Participant Flow|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138344|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
138345|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
138247|NCT01616459|P2|Participant Flow|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138248|NCT01616459|P1|Participant Flow|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138249|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138520|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
138250|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138251|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138252|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138253|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138254|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138346|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
138347|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
138348|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
139011|NCT01612676|B5|Baseline|Total|Total of all reporting groups
138255|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138256|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138257|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138258|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138259|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138260|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138261|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138262|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138349|NCT01616173|E3|Reported Event|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
138350|NCT01616173|E2|Reported Event|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
138351|NCT01616173|E1|Reported Event|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
139074|NCT01612494|B3|Baseline|Total|Total of all reporting groups
138263|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138264|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138265|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138266|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138267|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138268|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138269|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
138270|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138352|NCT01616056|B1|Baseline|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138353|NCT01616056|P1|Participant Flow|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138354|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138355|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138271|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138272|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138273|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138274|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138275|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138276|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138277|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
138278|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138356|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138357|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138358|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138359|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138279|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138280|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138281|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138282|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138283|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138284|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138285|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
138286|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138360|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138361|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138362|NCT01616056|O1|Outcome|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138363|NCT01616056|E1|Reported Event|Bandage Contact Lenses|Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
138287|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138288|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138289|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138290|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138291|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138292|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138293|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
138294|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138364|NCT01615939|B3|Baseline|Total|Total of all reporting groups
138365|NCT01615939|B2|Baseline|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
138295|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138296|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138297|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138298|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138299|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138300|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138301|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
138302|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138366|NCT01615939|B1|Baseline|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
138370|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
138303|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138304|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138305|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138306|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138307|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138308|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138309|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138310|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138367|NCT01615939|P2|Participant Flow|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
139075|NCT01612494|B2|Baseline|Hypertonic Saline|
139076|NCT01612494|B1|Baseline|Normal Saline|
138311|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138312|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138313|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138314|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138315|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138316|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138317|NCT01616459|O2|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138318|NCT01616459|O1|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138368|NCT01615939|P1|Participant Flow|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
138414|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138319|NCT01616459|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138320|NCT01616459|O1|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138321|NCT01616459|O2|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138322|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138323|NCT01616459|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138324|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138325|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
138326|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138369|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
139077|NCT01612494|P2|Participant Flow|Hypertonic Saline|
139078|NCT01612494|P1|Participant Flow|Normal Saline|
138327|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138328|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138375|NCT01615939|E2|Reported Event|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
138521|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
138329|NCT01616459|E4|Reported Event|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
138330|NCT01616459|E3|Reported Event|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138331|NCT01616459|E2|Reported Event|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138332|NCT01616459|E1|Reported Event|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
138333|NCT01616173|B4|Baseline|Total|Total of all reporting groups
138334|NCT01616173|B3|Baseline|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
138335|NCT01616173|B2|Baseline|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
138336|NCT01616173|B1|Baseline|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
138337|NCT01616173|P3|Participant Flow|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
138338|NCT01616173|P2|Participant Flow|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
138339|NCT01616173|P1|Participant Flow|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
138340|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
138341|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
138342|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
138343|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
138953|NCT01613014|B1|Baseline|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID
Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
138371|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
138372|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
138373|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
138376|NCT01615939|E1|Reported Event|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
138377|NCT01615822|B4|Baseline|Total|Total of all reporting groups
138378|NCT01615822|B3|Baseline|Placebo|Placebo
138379|NCT01615822|B2|Baseline|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension
Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
138380|NCT01615822|B1|Baseline|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension
Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
138381|NCT01615822|P3|Participant Flow|Placebo|Placebo
138382|NCT01615822|P2|Participant Flow|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension
Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
138383|NCT01615822|P1|Participant Flow|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension
Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
138384|NCT01615822|O2|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
138385|NCT01615822|O1|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
138386|NCT01615822|O2|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
138387|NCT01615822|O1|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
138388|NCT01615822|O4|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|"Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
OZ439 400mg: OZ439 400mg oral suspension, single dose
MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose"
138389|NCT01615822|O3|Outcome|OZ439 400mg Single Dose|"OZ439 400mg single dose oral suspension
OZ439 400mg: OZ439 400mg oral suspension, single dose"
138390|NCT01615822|O2|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|"Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
OZ439 100mg: OZ439 100mg oral suspension, single dose
MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose"
138391|NCT01615822|O1|Outcome|OZ439 100mg Single Dose|"OZ439 100mg single dose oral suspension
OZ439 100mg: OZ439 100mg oral suspension, single dose"
138392|NCT01615822|O4|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|"Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
OZ439 400mg: OZ439 400mg oral suspension, single dose
MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose"
138393|NCT01615822|O3|Outcome|OZ439 400mg Single Dose|"OZ439 400mg single dose oral suspension
OZ439 400mg: OZ439 400mg oral suspension, single dose"
138394|NCT01615822|O2|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|"Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
OZ439 100mg: OZ439 100mg oral suspension, single dose
MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose"
138395|NCT01615822|O1|Outcome|OZ439 100mg Single Dose|"OZ439 100mg single dose oral suspension
OZ439 100mg: OZ439 100mg oral suspension, single dose"
138396|NCT01615822|E3|Reported Event|Placebo|Placebo
138397|NCT01615822|E2|Reported Event|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension
Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
138398|NCT01615822|E1|Reported Event|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension
Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
138415|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
139079|NCT01612494|O2|Outcome|Hypertonic Saline|
138399|NCT01615809|B1|Baseline|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).
﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization was 10 ml (50 mg) twice a week for the first week, and then from the second week onwards was reduced to 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count demonstrated to be greater than or equal to 1500 cells/mm3."
138400|NCT01615809|P1|Participant Flow|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).
﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
138401|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).
﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
138421|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138563|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
138402|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).
﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
138403|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).
﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
138404|NCT01615809|E1|Reported Event|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).
﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
138405|NCT01615731|B3|Baseline|Total|Total of all reporting groups
138406|NCT01615731|B2|Baseline|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138407|NCT01615731|B1|Baseline|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138408|NCT01615731|P2|Participant Flow|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138409|NCT01615731|P1|Participant Flow|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138410|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138411|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138412|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138413|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138954|NCT01613014|P2|Participant Flow|ABT-436|"ABT-436 Target dose of 400 mg BID
ABT-436: Target dose - 400mg BID"
138416|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138417|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138418|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138419|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138420|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138518|NCT01614886|P2|Participant Flow|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
138422|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138423|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138424|NCT01615731|E2|Reported Event|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone
Mifepristone: 200mg Mifepristone orally
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138425|NCT01615731|E1|Reported Event|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op
Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os
Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
138426|NCT01615328|B3|Baseline|Total|Total of all reporting groups
138427|NCT01615328|B2|Baseline|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
138428|NCT01615328|B1|Baseline|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
138429|NCT01615328|P2|Participant Flow|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
138430|NCT01615328|P1|Participant Flow|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
138431|NCT01615328|O2|Outcome|Bonion|"The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.
Bonion: The ACDF surgery will be caried out with Bonion after randomization procedure."
138432|NCT01615328|O1|Outcome|Cervios ChronOs|"The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.
Cervios ChronOs: The ACDF surgery will be caried out with Cervios ChronOs after randomization procedure."
138433|NCT01615328|O2|Outcome|Bonion|"The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.
Bonion: The ACDF surgery will be carried out with Bonion after randomization procedure."
138434|NCT01615328|O1|Outcome|Cervios ChronOs|"The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.
Cervios ChronOs: The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure."
138435|NCT01615328|O2|Outcome|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
138436|NCT01615328|O1|Outcome|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
138437|NCT01615328|E2|Reported Event|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
138438|NCT01615328|E1|Reported Event|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
138439|NCT01615263|B3|Baseline|Total|Total of all reporting groups
138440|NCT01615263|B2|Baseline|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
138441|NCT01615263|B1|Baseline|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
138442|NCT01615263|P2|Participant Flow|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
138443|NCT01615263|P1|Participant Flow|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
138444|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
138445|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
138446|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
138447|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
138448|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
138449|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
138450|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
138451|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
138452|NCT01615263|E2|Reported Event|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9F, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
138453|NCT01615263|E1|Reported Event|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
138454|NCT01615198|B3|Baseline|Total|Total of all reporting groups
138455|NCT01615198|B2|Baseline|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138456|NCT01615198|B1|Baseline|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138457|NCT01615198|P2|Participant Flow|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138458|NCT01615198|P1|Participant Flow|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138459|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138460|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138461|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138462|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138463|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138464|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138465|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138466|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138955|NCT01613014|P1|Participant Flow|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID
Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
138467|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138468|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138469|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138470|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138471|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138472|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138473|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138474|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138475|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138476|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138477|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138478|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138479|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138480|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138481|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138482|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138668|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener’s granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
138483|NCT01615198|E2|Reported Event|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
138484|NCT01615198|E1|Reported Event|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
138485|NCT01615029|B6|Baseline|Total|Total of all reporting groups
138486|NCT01615029|B5|Baseline|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138487|NCT01615029|B4|Baseline|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138519|NCT01614886|P1|Participant Flow|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
138488|NCT01615029|B3|Baseline|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138489|NCT01615029|B2|Baseline|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138490|NCT01615029|B1|Baseline|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138491|NCT01615029|P5|Participant Flow|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138492|NCT01615029|P4|Participant Flow|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138493|NCT01615029|P3|Participant Flow|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138494|NCT01615029|P2|Participant Flow|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138495|NCT01615029|P1|Participant Flow|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138496|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138497|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138606|NCT01614470|B2|Baseline|Part 1: Placebo First, Then Ivacaftor|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
138498|NCT01615029|O4|Outcome|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138499|NCT01615029|O3|Outcome|Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138500|NCT01615029|O2|Outcome|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138501|NCT01615029|O1|Outcome|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138502|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138503|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138504|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138505|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138506|NCT01615029|O4|Outcome|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138507|NCT01615029|O3|Outcome|Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138508|NCT01615029|O2|Outcome|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138509|NCT01615029|O1|Outcome|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138510|NCT01615029|E5|Reported Event|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138511|NCT01615029|E4|Reported Event|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138607|NCT01614470|B1|Baseline|Part 1: Ivacaftor First, Then Placebo|Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
138512|NCT01615029|E3|Reported Event|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138513|NCT01615029|E2|Reported Event|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138514|NCT01615029|E1|Reported Event|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
138515|NCT01614886|B3|Baseline|Total|Total of all reporting groups
138516|NCT01614886|B2|Baseline|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
138517|NCT01614886|B1|Baseline|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
138522|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
138523|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
138524|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
138525|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
138526|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
138527|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
138528|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
138529|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
138530|NCT01614886|E2|Reported Event|Rivastigmine Patch 3-step|Rivastigmine patch 3-step
138531|NCT01614886|E1|Reported Event|Rivastigmine Patch 1-step|Rivastigmine patch 1-step
138532|NCT01614795|B5|Baseline|Total|Total of all reporting groups
138533|NCT01614795|B4|Baseline|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138534|NCT01614795|B3|Baseline|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138535|NCT01614795|B2|Baseline|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138608|NCT01614470|P3|Participant Flow|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
138669|NCT01613599|E1|Reported Event|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years
138536|NCT01614795|B1|Baseline|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138537|NCT01614795|P4|Participant Flow|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138538|NCT01614795|P3|Participant Flow|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138539|NCT01614795|P2|Participant Flow|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138540|NCT01614795|P1|Participant Flow|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138541|NCT01614795|O4|Outcome|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138542|NCT01614795|O3|Outcome|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138543|NCT01614795|O2|Outcome|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138544|NCT01614795|O1|Outcome|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138545|NCT01614795|E4|Reported Event|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138546|NCT01614795|E3|Reported Event|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138547|NCT01614795|E2|Reported Event|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138548|NCT01614795|E1|Reported Event|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies"
138549|NCT01614769|B1|Baseline|All Participants|All randomized participants
138550|NCT01614769|P6|Participant Flow|Glimepiride 4 mg → Glimepiride 2 mg → Placebo|Participants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
138551|NCT01614769|P5|Participant Flow|Glimepiride 2 mg → Placebo → Glimepiride 4 mg|Participants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
138552|NCT01614769|P4|Participant Flow|Placebo → Glimepiride 4 mg → Glimepiride 2 mg|Participants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
138553|NCT01614769|P3|Participant Flow|Glimepiride 4 mg → Placebo → Glimepiride 2 mg|Participants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
138554|NCT01614769|P2|Participant Flow|Glimepiride 2 mg → Glimepiride 4 mg → Placebo|Participants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
138555|NCT01614769|P1|Participant Flow|Placebo → Glimepiride 2 mg → Glimepiride 4 mg|Participants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
138556|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
138557|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
138558|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
138559|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
138560|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
138561|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
138562|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
138565|NCT01614769|E3|Reported Event|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
138566|NCT01614769|E2|Reported Event|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
138567|NCT01614769|E1|Reported Event|Placebo|Participants received placebo in a treatment period.
138568|NCT01614613|B1|Baseline|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
138569|NCT01614613|P1|Participant Flow|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal:safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips.
138570|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
138571|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
138572|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
138573|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
138670|NCT01613417|B3|Baseline|Total|Total of all reporting groups
138574|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
138575|NCT01614613|E1|Reported Event|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. Subgroup 1 goal:safely decrease subject glucose levels during the visit. Subgroup 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
138576|NCT01614600|B1|Baseline|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
138577|NCT01614600|P1|Participant Flow|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
138578|NCT01614600|O1|Outcome|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
138579|NCT01614600|E1|Reported Event|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
138580|NCT01614574|B1|Baseline|VPRIV® (15-60 U/kg)|
138581|NCT01614574|P1|Participant Flow|VPRIV® (15-60 U/kg)|
138582|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
138583|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
138584|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
138585|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
138586|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
138587|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
138588|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
138589|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
138590|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
138591|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
138592|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
138593|NCT01614574|E1|Reported Event|VPRIV® (15-60 U/kg)|
138594|NCT01614509|B3|Baseline|Total|Total of all reporting groups
138624|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138625|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138595|NCT01614509|B2|Baseline|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
138596|NCT01614509|B1|Baseline|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
138597|NCT01614509|P2|Participant Flow|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
138598|NCT01614509|P1|Participant Flow|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
138599|NCT01614509|O2|Outcome|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
138600|NCT01614509|O1|Outcome|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
138601|NCT01614509|O2|Outcome|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
138602|NCT01614509|O1|Outcome|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
138603|NCT01614509|E2|Reported Event|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
138604|NCT01614509|E1|Reported Event|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
138605|NCT01614470|B3|Baseline|Total|Total of all reporting groups
138666|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
138609|NCT01614470|P2|Participant Flow|Part 1: Placebo First, Then Ivacaftor|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
138610|NCT01614470|P1|Participant Flow|Part 1: Ivacaftor First, Then Placebo|Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
138611|NCT01614470|O1|Outcome|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
138612|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138613|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138614|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
138615|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138616|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138617|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
138618|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
138619|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138620|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138621|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
138622|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138623|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138626|NCT01614470|E3|Reported Event|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
138627|NCT01614470|E2|Reported Event|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138628|NCT01614470|E1|Reported Event|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
138629|NCT01614457|B3|Baseline|Total|Total of all reporting groups
138630|NCT01614457|B2|Baseline|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
138631|NCT01614457|B1|Baseline|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
138632|NCT01614457|P2|Participant Flow|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
138633|NCT01614457|P1|Participant Flow|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
138634|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
138635|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
138636|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
138637|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
138638|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
138639|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
138640|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
138641|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
138642|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
138643|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
138644|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
138645|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
138646|NCT01614457|E2|Reported Event|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
138647|NCT01614457|E1|Reported Event|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
138648|NCT01614249|B3|Baseline|Total|Total of all reporting groups
138649|NCT01614249|B2|Baseline|Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group|"As the intervention group, participants received a dietary supplement of Omega Via fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits to resupply the soft-gels, monitoring of side effects and compliance and data collection.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Each participants took three soft gels of fish oil omega-3 fatty acid per day, each containing more EPA (0.715 grams) than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
138667|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
139080|NCT01612494|O1|Outcome|Normal Saline|
138650|NCT01614249|B1|Baseline|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
138651|NCT01614249|P2|Participant Flow|Fish Oil Omega-3 EPA-rich Experimental Group|"As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
138652|NCT01614249|P1|Participant Flow|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
138695|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
138696|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
138697|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
138698|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
138699|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
138700|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
138701|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
138653|NCT01614249|O2|Outcome|Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group|"As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
138654|NCT01614249|O1|Outcome|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.
Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
138655|NCT01614249|E2|Reported Event|Fish Oil Omega-3 EPA-rich Soft Gels|"Participants received OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight (8) weeks with bi-weekly follow-up visits for monitoring of side effects and compliance and data collection.
Fish oil omega-3 EPA-rich soft gels: A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels was taken orally per day as one soft gel in the morning, mid-day and evening after meals for 8 weeks with bi-weekly follow-up visits."
138656|NCT01614249|E1|Reported Event|Soybean Oil Soft Gels|"Participants on this arm received a dietary supplement of OmegaVia soybean oil soft gels as a placebo for 8 weeks with bi-weekly follow-up visits to monitor side effects and compliance.
Soybean oil soft gels: Each participant received OmegaVia soybean oil soft gels to take orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
138657|NCT01613599|B1|Baseline|Rituximab|Participants with GPA (Wegener’s granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
138658|NCT01613599|P1|Participant Flow|Rituximab|Participants with granulomatosis with polyangiitis (GPA) (Wegener’s granulomatosis) or microscopic polyangiitis (MPA) who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
138659|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
138660|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
138661|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
138662|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
138663|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
138664|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
138665|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
138671|NCT01613417|B2|Baseline|Gadovist/Gadavist Then ProHance|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
138672|NCT01613417|B1|Baseline|ProHance Then Gadovist/Gadavist|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
138673|NCT01613417|P2|Participant Flow|Sequence 2 (Gadovist/Gadavist Then ProHance)|Patients randomized to receive Gadovist/Gadavist first
138674|NCT01613417|P1|Participant Flow|Sequence 1 (ProHance Then Gadovist/Gadavist)|Patients randomized to receive ProHance first
138675|NCT01613417|O6|Outcome|Reader 3 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
138676|NCT01613417|O5|Outcome|Reader 3 - ProHance|MRI after ProHance 0.1 mmol/kg
138677|NCT01613417|O4|Outcome|Reader 2 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
138678|NCT01613417|O3|Outcome|Reader 2 - ProHance|MRI after ProHance 0.1 mmol/kg
138679|NCT01613417|O2|Outcome|Reader 1 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
138680|NCT01613417|O1|Outcome|Reader 1 - ProHance|MRI after ProHance 0.1 mmol/kg
138681|NCT01613417|O6|Outcome|Reader 3 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
138682|NCT01613417|O5|Outcome|Reader 3 - ProHance|MRI after ProHance 0.1 mmol/kg
138683|NCT01613417|O4|Outcome|Reader 2 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
138684|NCT01613417|O3|Outcome|Reader 2 - ProHance|MRI after ProHance 0.1 mmol/kg
138685|NCT01613417|O2|Outcome|Reader 1 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
138686|NCT01613417|O1|Outcome|Reader 1 - ProHance|MRI after ProHance 0.1 mmol/kg
138687|NCT01613417|O3|Outcome|Reader 3|Lesions reviewed by Reader 3
138688|NCT01613417|O2|Outcome|Reader 2|Lesions reviewed by Reader 2
138689|NCT01613417|O1|Outcome|Reader 1|Lesions reviewed by Reader 1
138690|NCT01613417|O3|Outcome|Reader 3|Lesions reviewed by Reader 3
138691|NCT01613417|O2|Outcome|Reader 2|Lesions reviewed by Reader 2
138692|NCT01613417|O1|Outcome|Reader 1|Lesions reviewed by Reader 1
138693|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
138694|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
138708|NCT01613417|E2|Reported Event|Safety Population (Gadovist/Gadavist)|All enrolled patients who received a randomized injection of Gadovist/Gadavist
138709|NCT01613417|E1|Reported Event|Safety Population (ProHance)|All enrolled patients who received a randomized injection of ProHance
138710|NCT01613378|B1|Baseline|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138711|NCT01613378|P1|Participant Flow|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138712|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138713|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138714|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138715|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138716|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138717|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138718|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138719|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138720|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138721|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138722|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138723|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138724|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138725|NCT01613378|E1|Reported Event|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study"
138726|NCT01613339|B3|Baseline|Total|Total of all reporting groups
138727|NCT01613339|B2|Baseline|Control|No specific treatment.
138728|NCT01613339|B1|Baseline|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
138729|NCT01613339|P2|Participant Flow|Control|No specific treatment.
138730|NCT01613339|P1|Participant Flow|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
138731|NCT01613339|O2|Outcome|Control|No specific treatment.
138732|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
138733|NCT01613339|O2|Outcome|Control|No specific treatment.
138734|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
138735|NCT01613339|O2|Outcome|Control|No specific treatment.
138736|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
138737|NCT01613339|E1|Reported Event|Body Awareness Therapy, Control|group training. Controls were asked to continue with their lifestyle.
138738|NCT01613326|B3|Baseline|Total|Total of all reporting groups
141892|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
138739|NCT01613326|B2|Baseline|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138740|NCT01613326|B1|Baseline|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138741|NCT01613326|P2|Participant Flow|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138742|NCT01613326|P1|Participant Flow|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138743|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138744|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138745|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138746|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138747|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138748|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138749|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138750|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138751|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138752|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138753|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138754|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138755|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138756|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138948|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138757|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138758|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138759|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138760|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138761|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138762|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138763|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138764|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138765|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138766|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138767|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138768|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138769|NCT01613326|E2|Reported Event|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138770|NCT01613326|E1|Reported Event|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
138771|NCT01613313|B5|Baseline|Total|Total of all reporting groups
138772|NCT01613313|B4|Baseline|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138773|NCT01613313|B3|Baseline|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138774|NCT01613313|B2|Baseline|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138775|NCT01613313|B1|Baseline|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138776|NCT01613313|P4|Participant Flow|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138777|NCT01613313|P3|Participant Flow|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138778|NCT01613313|P2|Participant Flow|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138779|NCT01613313|P1|Participant Flow|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138780|NCT01613313|O4|Outcome|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138781|NCT01613313|O3|Outcome|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138782|NCT01613313|O2|Outcome|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138783|NCT01613313|O1|Outcome|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138784|NCT01613313|O4|Outcome|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138785|NCT01613313|O3|Outcome|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138786|NCT01613313|O2|Outcome|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138787|NCT01613313|O1|Outcome|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138949|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138788|NCT01613313|E4|Reported Event|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138789|NCT01613313|E3|Reported Event|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138790|NCT01613313|E2|Reported Event|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138791|NCT01613313|E1|Reported Event|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum
Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
138792|NCT01613248|B7|Baseline|Total|Total of all reporting groups
138793|NCT01613248|B6|Baseline|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138794|NCT01613248|B5|Baseline|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138795|NCT01613248|B4|Baseline|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138796|NCT01613248|B3|Baseline|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138797|NCT01613248|B2|Baseline|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138798|NCT01613248|B1|Baseline|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138799|NCT01613248|P6|Participant Flow|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138800|NCT01613248|P5|Participant Flow|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138801|NCT01613248|P4|Participant Flow|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138802|NCT01613248|P3|Participant Flow|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138803|NCT01613248|P2|Participant Flow|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138804|NCT01613248|P1|Participant Flow|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138805|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138806|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138807|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138808|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138809|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138810|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138811|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138812|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138813|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138814|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138815|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138816|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138817|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138818|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138819|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138820|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
139081|NCT01612494|E2|Reported Event|Hypertonic Saline|
138821|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138822|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138823|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138824|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138825|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138826|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138827|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138828|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138829|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138830|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138831|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138832|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138833|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138834|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138835|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138836|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138837|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138838|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138839|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138840|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138841|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138842|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138843|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138844|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138845|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138846|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138847|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138848|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138849|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138850|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138851|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138852|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138853|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138854|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138855|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138856|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138857|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138858|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138859|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138860|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138861|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138862|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138863|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138864|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138865|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138866|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138867|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138868|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138869|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138870|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138871|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138872|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138873|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138874|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138875|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138876|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138877|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138878|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138879|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138880|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138881|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138882|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138883|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138884|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138885|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138886|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138887|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138888|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138889|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138890|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138891|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138892|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138893|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138894|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138895|NCT01613248|E6|Reported Event|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138896|NCT01613248|E5|Reported Event|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138897|NCT01613248|E4|Reported Event|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138898|NCT01613248|E3|Reported Event|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138899|NCT01613248|E2|Reported Event|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138900|NCT01613248|E1|Reported Event|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
138901|NCT01613131|B3|Baseline|Total|Total of all reporting groups
138902|NCT01613131|B2|Baseline|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138903|NCT01613131|B1|Baseline|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138904|NCT01613131|P2|Participant Flow|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138978|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
138979|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
138905|NCT01613131|P1|Participant Flow|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138906|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138907|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138908|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138909|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138910|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138911|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138912|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138913|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138914|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138915|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138950|NCT01613027|E1|Reported Event|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138951|NCT01613014|B3|Baseline|Total|Total of all reporting groups
138916|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138917|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138918|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138919|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138920|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138921|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138922|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138923|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138924|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138925|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138926|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138980|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
141893|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
138927|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138928|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138929|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138930|NCT01613131|E2|Reported Event|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
138931|NCT01613131|E1|Reported Event|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.
Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
Estradiol: Topical, .06%, Applied once daily for 50 days."
138932|NCT01613027|B1|Baseline|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138933|NCT01613027|P1|Participant Flow|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138934|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138935|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138936|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138937|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138938|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138939|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138940|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138941|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138942|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138943|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138944|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138945|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138946|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138947|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
138957|NCT01613014|O1|Outcome|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID
Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
138958|NCT01613014|E2|Reported Event|ABT-436|"ABT-436 Target dose of 400 mg BID
ABT-436: Target dose - 400mg BID"
138959|NCT01613014|E1|Reported Event|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID
Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
138960|NCT01612858|B3|Baseline|Total|Total of all reporting groups
138961|NCT01612858|B2|Baseline|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
138962|NCT01612858|B1|Baseline|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
138963|NCT01612858|P2|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
138964|NCT01612858|P1|Participant Flow|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
138965|NCT01612858|O2|Outcome|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
138966|NCT01612858|O1|Outcome|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
138967|NCT01612858|O2|Outcome|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
138968|NCT01612858|O1|Outcome|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
138969|NCT01612858|E2|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
138970|NCT01612858|E1|Reported Event|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
138971|NCT01612767|B1|Baseline|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
138972|NCT01612767|P1|Participant Flow|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
138973|NCT01612767|O4|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138974|NCT01612767|O3|Outcome|PRO-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138975|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - Discharge|PRO-Kinetic Energy Stent: Coronary artery stent implant
138976|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - Baseline|PRO-Kinetic Energy Stent: Coronary artery stent implant
138977|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
138981|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138982|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138983|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138984|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138985|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138986|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138987|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138988|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138989|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138990|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138991|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138992|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138993|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138994|NCT01612767|O1|Outcome|PRO-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138995|NCT01612767|O1|Outcome|PRO-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
138996|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
138997|NCT01612767|E1|Reported Event|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
138998|NCT01612702|B3|Baseline|Total|Total of all reporting groups
138999|NCT01612702|B2|Baseline|Control|No dexamethasone
139000|NCT01612702|B1|Baseline|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
139001|NCT01612702|P2|Participant Flow|Control|No dexamethasone
139002|NCT01612702|P1|Participant Flow|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
139003|NCT01612702|O2|Outcome|Control|No dexamethasone
139004|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
139005|NCT01612702|O2|Outcome|Control|No dexamethasone
139006|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
139007|NCT01612702|O2|Outcome|Control|No dexamethasone
139008|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
139009|NCT01612702|E2|Reported Event|Control|No dexamethasone
139012|NCT01612676|B4|Baseline|Infusion Regimen 4|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139013|NCT01612676|B3|Baseline|Infusion Regimen 3|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139014|NCT01612676|B2|Baseline|Infusion Regimen 2|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139015|NCT01612676|B1|Baseline|Infusion Regimen 1|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139016|NCT01612676|P4|Participant Flow|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139017|NCT01612676|P3|Participant Flow|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139018|NCT01612676|P2|Participant Flow|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139019|NCT01612676|P1|Participant Flow|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139020|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139021|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139124|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139022|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139023|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139024|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139025|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139026|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139027|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139028|NCT01612676|O1|Outcome|Full Analysis Set|The full analysis data set (FAS) comprised data from all dosed patients.
139029|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139030|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139031|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139032|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139082|NCT01612494|E1|Reported Event|Normal Saline|
139033|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139034|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139035|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139036|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139037|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139038|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139039|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139040|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139041|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139125|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139042|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139043|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139044|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139045|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139046|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139047|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139048|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139049|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139050|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139051|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139052|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139083|NCT01612221|B3|Baseline|Total|Total of all reporting groups
145187|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
139053|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139054|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139055|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139056|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139057|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139058|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139059|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139060|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139061|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139062|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139063|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139064|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139065|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139066|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139067|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139068|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139069|NCT01612676|E5|Reported Event|Total|Summation of adverse events in all treatment arms
139070|NCT01612676|E4|Reported Event|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139071|NCT01612676|E3|Reported Event|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139072|NCT01612676|E2|Reported Event|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139073|NCT01612676|E1|Reported Event|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
139084|NCT01612221|B2|Baseline|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)
Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.
Then repeated 24 hours later."
139085|NCT01612221|B1|Baseline|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)
N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
139086|NCT01612221|P2|Participant Flow|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)
Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.
Then repeated 24 hours later."
139087|NCT01612221|P1|Participant Flow|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)
N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
139088|NCT01612221|O2|Outcome|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)
Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.
Then repeated 24 hours later."
139089|NCT01612221|O1|Outcome|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)
N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
139090|NCT01612221|O2|Outcome|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)
Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.
Then repeated 24 hours later."
139091|NCT01612221|O1|Outcome|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)
N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
139092|NCT01612221|E2|Reported Event|Placebo Group|"Participants not receiving NAC (N-acetylcysteine)
Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.
Then repeated 24 hours later."
139093|NCT01612221|E1|Reported Event|Patients Receiving N-acetylcysteine|"Patients receiving NAC (N-acetylcysteine)
N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses"
139094|NCT01612156|B3|Baseline|Total|Total of all reporting groups
139095|NCT01612156|B2|Baseline|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
139096|NCT01612156|B1|Baseline|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
139097|NCT01612156|P2|Participant Flow|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
139158|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139098|NCT01612156|P1|Participant Flow|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
139099|NCT01612156|O2|Outcome|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
139100|NCT01612156|O1|Outcome|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
139101|NCT01612156|O2|Outcome|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
139102|NCT01612156|O1|Outcome|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
139103|NCT01612156|E2|Reported Event|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
139104|NCT01612156|E1|Reported Event|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
139105|NCT01612000|B5|Baseline|Total|Total of all reporting groups
139106|NCT01612000|B4|Baseline|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139107|NCT01612000|B3|Baseline|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection"
139108|NCT01612000|B2|Baseline|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139109|NCT01612000|B1|Baseline|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139110|NCT01612000|P4|Participant Flow|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139111|NCT01612000|P3|Participant Flow|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection"
139112|NCT01612000|P2|Participant Flow|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139113|NCT01612000|P1|Participant Flow|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139114|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139115|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection"
139116|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139117|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139118|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139119|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection"
139120|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139121|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139122|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139123|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection"
139126|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139127|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection"
139128|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139129|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139130|NCT01612000|E4|Reported Event|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139131|NCT01612000|E3|Reported Event|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection"
139132|NCT01612000|E2|Reported Event|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139133|NCT01612000|E1|Reported Event|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok: Intramuscular injection
rHA adjuvant: Intramuscular injection"
139134|NCT01611974|B4|Baseline|Total|Total of all reporting groups
139135|NCT01611974|B3|Baseline|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139136|NCT01611974|B2|Baseline|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139137|NCT01611974|B1|Baseline|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139138|NCT01611974|P3|Participant Flow|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139139|NCT01611974|P2|Participant Flow|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139176|NCT01611948|B1|Baseline|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
139140|NCT01611974|P1|Participant Flow|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139141|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139142|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139143|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139144|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139145|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139146|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139147|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139148|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139149|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139150|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139151|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139152|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139153|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139154|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139155|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139156|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139157|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
141894|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
139159|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139160|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139161|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139162|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139163|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139164|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139165|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139166|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139167|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139168|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139169|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139170|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139171|NCT01611974|E3|Reported Event|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139172|NCT01611974|E2|Reported Event|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139173|NCT01611974|E1|Reported Event|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
139174|NCT01611948|B3|Baseline|Total|Total of all reporting groups
139175|NCT01611948|B2|Baseline|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
139177|NCT01611948|P2|Participant Flow|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
139178|NCT01611948|P1|Participant Flow|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
139179|NCT01611948|O2|Outcome|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
139180|NCT01611948|O1|Outcome|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
139181|NCT01611948|E2|Reported Event|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
139182|NCT01611948|E1|Reported Event|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
139183|NCT01611883|B3|Baseline|Total|Total of all reporting groups
139184|NCT01611883|B2|Baseline|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139185|NCT01611883|B1|Baseline|Ezetimibe|10 mg oral dose once daily for 24 weeks
139186|NCT01611883|P2|Participant Flow|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139187|NCT01611883|P1|Participant Flow|Ezetimibe|10 mg oral dose once daily for 24 weeks
139188|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139189|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
139190|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139191|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
139192|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139193|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
139194|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139195|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
139196|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139197|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
139198|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139199|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
139200|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139201|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
139202|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139203|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
139204|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139205|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
139206|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139207|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
139208|NCT01611883|E2|Reported Event|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
139209|NCT01611883|E1|Reported Event|Ezetimibe|10 mg oral dose once daily for 24 weeks
139210|NCT01611857|B3|Baseline|Total|Total of all reporting groups
139211|NCT01611857|B2|Baseline|Tivantinib+FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle;
FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle.
Treatment continued until disease progression or unacceptable toxicity."
139212|NCT01611857|B1|Baseline|Tivantinib+FOLFOX Dose Escalation|"Tivantinib: (120 mg, 240 mg, or 360 mg) orally, twice daily on Days 1-14 of each 2 week cycle.
FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
139213|NCT01611857|P2|Participant Flow|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle.
FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle."
139214|NCT01611857|P1|Participant Flow|Tivantinib + FOLFOX Dose Escalation|"Tivantinib: (120 mg; 240 mg; or 360 mg) orally, twice daily (PO BID) on Days 1-14 of each 2 week cycle;
FOLFOX: [5-Fluorouracil (5-FU) 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2] on Day 1 each cycle."
139215|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.
Treatment continued until disease progression or unacceptable toxicity."
139216|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.
Treatment continued until disease progression or unacceptable toxicity."
139217|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.
Treatment continued until disease progression or unacceptable toxicity."
139218|NCT01611857|O3|Outcome|Tivantinib 360 mg (PO BID) + FOLFOX|"Tivantinib 360 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle cycle;
FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
139219|NCT01611857|O2|Outcome|Tivantinib 240 mg (PO BID) + FOLFOX|"Tivantinib 240 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle;
FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
139220|NCT01611857|O1|Outcome|Tivantinib 120 mg (PO BID) + FOLFOX|"Tivantinib 120 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle;
FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
139288|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139221|NCT01611857|E2|Reported Event|Tivantinib+FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle.
Treatment continued until disease progression or unacceptable toxicity."
139222|NCT01611857|E1|Reported Event|Tivantinib+FOLFOX Dose Escalation|Tivantinib: orally, twice daily (PO BID) on Days 1-14 of each 2 week cycle; FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle.
139223|NCT01611792|B3|Baseline|Total|Total of all reporting groups
139224|NCT01611792|B2|Baseline|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
139225|NCT01611792|B1|Baseline|Stabilization|"Stabilization
Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
139226|NCT01611792|P2|Participant Flow|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
139242|NCT01611779|B1|Baseline|Tongue Suspension|"Tongue-based suspension
Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
139243|NCT01611779|P1|Participant Flow|Tongue Suspension|"Tongue-based suspension
Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
139227|NCT01611792|P1|Participant Flow|Low Back Pain|"Stabilization
Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
139228|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
139229|NCT01611792|O1|Outcome|Stabilization|Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
139230|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
139289|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139231|NCT01611792|O1|Outcome|Stabilization|Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
139232|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
139233|NCT01611792|O1|Outcome|Stabilization|Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
139244|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension
Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
139245|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension
Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
139246|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension
Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
139594|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139234|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
139235|NCT01611792|O1|Outcome|Stabilization|Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
139236|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
139237|NCT01611792|O1|Outcome|Stabilization|"Stabilization
Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
139238|NCT01611792|O2|Outcome|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
139239|NCT01611792|O1|Outcome|Stabilization|"Stabilization
Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
139240|NCT01611792|E2|Reported Event|Strengthening and Conditioning|Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
139241|NCT01611792|E1|Reported Event|Stabilization|"Stabilization
Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities."
139247|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension
Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
139248|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension
Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
139249|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension
Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
139250|NCT01611779|E1|Reported Event|Tongue Suspension|"Tongue-based suspension
Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
139251|NCT01611662|B1|Baseline|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.
gemcitabine hydrochloride: Given IV
cisplatin: Given IV
therapeutic conventional surgery: Undergo radical cystectomy
laboratory biomarker analysis: Correlative studies"
139252|NCT01611662|P1|Participant Flow|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.
gemcitabine hydrochloride: Given IV
cisplatin: Given IV
therapeutic conventional surgery: Undergo radical cystectomy
laboratory biomarker analysis: Correlative studies"
139253|NCT01611662|O1|Outcome|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.
gemcitabine hydrochloride: Given IV
cisplatin: Given IV
therapeutic conventional surgery: Undergo radical cystectomy
laboratory biomarker analysis: Correlative studies"
139254|NCT01611662|E1|Reported Event|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.
gemcitabine hydrochloride: Given IV
cisplatin: Given IV
therapeutic conventional surgery: Undergo radical cystectomy
laboratory biomarker analysis: Correlative studies"
139255|NCT01611571|B4|Baseline|Total|Total of all reporting groups
139290|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139256|NCT01611571|B3|Baseline|Placebo Risedronate Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months
Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
139257|NCT01611571|B2|Baseline|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide
Risedronic acid : weekly risedronate daily teriparatide (placebo)"
139258|NCT01611571|B1|Baseline|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide
Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
139259|NCT01611571|P3|Participant Flow|Placebo Risedronate + Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months
Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
139260|NCT01611571|P2|Participant Flow|Active Risedronte + Placebo Teriparatide|"Active Risedronte Placebo Teriparatide
Risedronic acid : weekly risedronate daily teriparatide (placebo)"
139261|NCT01611571|P1|Participant Flow|Active Risedronate + Active Teriparatide|"Active Risedronate Active Teriparatide
Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
139262|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months
Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
139263|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide
Risedronic acid : weekly risedronate daily teriparatide (placebo)"
139264|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide
Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
139265|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months
Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
139266|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide
Risedronic acid : weekly risedronate daily teriparatide (placebo)"
139267|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide
Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
139268|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months
Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
139269|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide
Risedronic acid : weekly risedronate daily teriparatide (placebo)"
139270|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide
Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
139271|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months
Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
139272|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide
Risedronic acid : weekly risedronate daily teriparatide (placebo)"
139273|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide
Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
139274|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months
Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
139275|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide
Risedronic acid : weekly risedronate daily teriparatide (placebo)"
139276|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide
Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
139277|NCT01611571|E3|Reported Event|Placebo Risedronate Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months
Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
139278|NCT01611571|E2|Reported Event|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide
Risedronic acid : weekly risedronate daily teriparatide (placebo)"
139279|NCT01611571|E1|Reported Event|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide
Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
139280|NCT01611558|B1|Baseline|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
139281|NCT01611558|P1|Participant Flow|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
139282|NCT01611558|O1|Outcome|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
139283|NCT01611558|O1|Outcome|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
139284|NCT01611558|O1|Outcome|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
139285|NCT01611558|E1|Reported Event|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
139286|NCT01610791|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139287|NCT01610791|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 milligrams per kilogram (mg/kg), intravenously (IV), once every 4 weeks for a total of 6 infusions.
145188|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
139291|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139292|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139293|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139294|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139295|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139296|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139297|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139298|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139299|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139300|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139301|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139302|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139303|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139304|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139305|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139306|NCT01610791|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
139307|NCT01610713|B3|Baseline|Total|Total of all reporting groups
139308|NCT01610713|B2|Baseline|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139309|NCT01610713|B1|Baseline|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139382|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139383|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139310|NCT01610713|P2|Participant Flow|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139311|NCT01610713|P1|Participant Flow|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139312|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139313|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139314|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139315|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139316|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139317|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139367|NCT01610700|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
145189|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
139318|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139319|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139320|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139321|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139322|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139323|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139324|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139384|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139325|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139326|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139327|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139328|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139329|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139330|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139331|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139332|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139333|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139626|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139334|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139335|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139336|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139337|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139338|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139339|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139340|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139341|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139342|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139343|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139344|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139345|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139346|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139347|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139348|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139349|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139627|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139350|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139351|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139352|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139353|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139354|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139355|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139356|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139357|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139358|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139359|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139360|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139361|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139362|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139363|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139364|NCT01610713|E2|Reported Event|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139365|NCT01610713|E1|Reported Event|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139366|NCT01610700|B3|Baseline|Total|Total of all reporting groups
139368|NCT01610700|B1|Baseline|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139369|NCT01610700|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139370|NCT01610700|P1|Participant Flow|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139371|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139372|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139373|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139374|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139375|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139376|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139377|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139378|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139379|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139380|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139381|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139593|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139385|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139386|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139387|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139388|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139389|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139390|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139391|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139392|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139393|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139394|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139395|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139396|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139397|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139398|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139399|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139400|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139628|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
139401|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139402|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139403|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139404|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139405|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139406|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139407|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139408|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139409|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139410|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139411|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139412|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139413|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139414|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139415|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139416|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139417|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139590|NCT01610037|P3|Participant Flow|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139418|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139419|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139420|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139421|NCT01610700|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
139422|NCT01610700|E1|Reported Event|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
139423|NCT01610687|B1|Baseline|GW-1000-02|Active treatment
139424|NCT01610687|P1|Participant Flow|GW-1000-02|GW-1000-02 contains Δ tetrahydrocannabinol, 27 mg/ml and cannabidiol, 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
139425|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
139426|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
139427|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
139428|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
139429|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
139430|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
139483|NCT01610557|O1|Outcome|Bevacizumab|Represents the estimated effect of bevacizumab for a 3-month period, adjusted for period and baseline value.
140886|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
139431|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
139432|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
139433|NCT01610687|E1|Reported Event|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
139434|NCT01610596|B3|Baseline|Total|Total of all reporting groups
139435|NCT01610596|B2|Baseline|Vehicle Lotion|"Topical lotion, applied twice daily
Placebo"
139436|NCT01610596|B1|Baseline|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
139437|NCT01610596|P2|Participant Flow|Vehicle Lotion|"Topical lotion, applied twice daily
Placebo"
139438|NCT01610596|P1|Participant Flow|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week"
139439|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily
Placebo"
139440|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
139441|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily
Placebo"
139442|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
139443|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily
Placebo"
139444|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
139445|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily
Placebo"
139446|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
139447|NCT01610596|E2|Reported Event|Vehicle Lotion|"Topical lotion, applied twice daily
Placebo"
139448|NCT01610596|E1|Reported Event|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week"
139449|NCT01610570|B5|Baseline|Total|Total of all reporting groups
139525|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139450|NCT01610570|B4|Baseline|Phase 2|Expansion phase 17.5 mcg/kg.dose Mithramycin: Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously.
139451|NCT01610570|B3|Baseline|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
139452|NCT01610570|B2|Baseline|Phase 1 Dose Level 1|Dose Escalation Phase 13.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
139453|NCT01610570|B1|Baseline|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
139484|NCT01610557|E7|Reported Event|Ranibizumab and Bevacizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis. Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.
Participants with two eyes assigned who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.
Participants for whom one eye was assigned (unilateral participants) are not included."
139516|NCT01610167|P2|Participant Flow|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139454|NCT01610570|P4|Participant Flow|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Mithramycin: Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously.
139455|NCT01610570|P3|Participant Flow|Phase 1 Dose Level 2|"Dose Escalation Phase
17.5 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
139456|NCT01610570|P2|Participant Flow|Phase 1 Dose Level 1|"Dose Escalation Phase
13.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
139457|NCT01610570|P1|Participant Flow|Phase I Dose Level -1|"Dose Escalation Phase
9.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
139641|NCT01609790|B4|Baseline|Total|Total of all reporting groups
139458|NCT01610570|O4|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139459|NCT01610570|O3|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139460|NCT01610570|O2|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139461|NCT01610570|O1|Outcome|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139562|NCT01610076|E1|Reported Event|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
139462|NCT01610570|O1|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139463|NCT01610570|O3|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139464|NCT01610570|O2|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139526|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139591|NCT01610037|P2|Participant Flow|Tiotropium|18 μg capsules for inhalation, o.d
139465|NCT01610570|O1|Outcome|Phase I Dose Level -1|Dose Escalation Ph 9.0 mcg/kg dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139466|NCT01610570|E4|Reported Event|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139467|NCT01610570|E3|Reported Event|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139468|NCT01610570|E2|Reported Event|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139485|NCT01610557|E6|Reported Event|Bevacizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.
Participants with one eye assigned in either Group 3 or Group 4 who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.
Participants for whom two eyes were assigned (bilateral participants) are not included."
139469|NCT01610570|E1|Reported Event|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
139470|NCT01610557|B5|Baseline|Total|Total of all reporting groups
139471|NCT01610557|B4|Baseline|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139472|NCT01610557|B3|Baseline|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139527|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139528|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139529|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139473|NCT01610557|B2|Baseline|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139474|NCT01610557|B1|Baseline|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139475|NCT01610557|P5|Participant Flow|Ranibizumab/Bevacizumab As Needed|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis. Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.
53 participants attended at least one follow-up visit in the post-36-week extension phase: 49 participants who had one eye enrolled and 4 participants who had two eyes enrolled."
139476|NCT01610557|P4|Participant Flow|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139477|NCT01610557|P3|Participant Flow|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139478|NCT01610557|P2|Participant Flow|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139479|NCT01610557|P1|Participant Flow|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139480|NCT01610557|O2|Outcome|Ranibizumab|Represents the estimated effect of ranibizumab for a 3-month period, adjusted for period and baseline value.
139481|NCT01610557|O1|Outcome|Bevacizumab|Represents the estimated effect of bevacizumab for a 3-month period, adjusted for period and baseline value.
139482|NCT01610557|O2|Outcome|Ranibizumab|Represents the estimated effect of ranibizumab for a 3-month period, adjusted for period and baseline value.
139563|NCT01610063|B3|Baseline|Total|Total of all reporting groups
139486|NCT01610557|E5|Reported Event|Ranibizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis.
Participants with one eye assigned in either Group 1 or Group 2 who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.
Participants for whom two eyes were assigned (bilateral participants) are not included."
139487|NCT01610557|E4|Reported Event|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139488|NCT01610557|E3|Reported Event|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139530|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139531|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139592|NCT01610037|P1|Participant Flow|QVA149|110/50 µg capsules for inhalation, o.d
139489|NCT01610557|E2|Reported Event|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139490|NCT01610557|E1|Reported Event|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).
Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
139491|NCT01610492|B1|Baseline|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
139492|NCT01610492|P1|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
139493|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
139494|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
139495|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
139496|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
139497|NCT01610492|E1|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
139498|NCT01610453|B1|Baseline|Transperineal Ultrasound|Fetal head descent was assessed using a transperineal scan
139499|NCT01610453|P1|Participant Flow|Results From Transperineal Scan|"Primiparous women with prolonged labours was eligible for the study. Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK and Department of Obstetrics and Gynecology, Stavanger University Hospital, Stavanger, Norway participated.
Ultrasound examination: a transperineal sonography was done when prolonged labor was diagnosed. Prolonged labor was diagnosed in accordance with WHO recommendations in Stavanger and in accordance with NICE guidelines in Cambridge"
139500|NCT01610453|O1|Outcome|Transabdominal Ultrasound|Fetal head position was assessed using a transabdominal scan
139501|NCT01610453|O1|Outcome|Transperineal Ultrasound|Fetal head descent was assessed using a transperineal scan
139502|NCT01610453|E1|Reported Event|Transabdominal and Transperineal Sonography|Fetal head position was assessed using a transabdominal scan and fetal station was assessed by transperineal scan
139503|NCT01610297|B1|Baseline|ICL670|Oral dose of ICL670 at 10 mg/kg daily
139504|NCT01610297|P1|Participant Flow|ICL670|Oral dose of ICL670 at 10 mg/kg daily
139505|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
139506|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
139507|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
139508|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
139509|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
139510|NCT01610297|E1|Reported Event|ICL670|Oral dose of ICL670 at 10 mg/kg daily
139511|NCT01610167|B4|Baseline|Total|Total of all reporting groups
139512|NCT01610167|B3|Baseline|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139513|NCT01610167|B2|Baseline|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139514|NCT01610167|B1|Baseline|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139515|NCT01610167|P3|Participant Flow|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139564|NCT01610063|B2|Baseline|Unguided|Treatment as usual
145190|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
139517|NCT01610167|P1|Participant Flow|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139518|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139519|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139520|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139521|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139522|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139523|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139524|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139588|NCT01610037|B2|Baseline|Tiotropium|18 μg capsules for inhalation, o.d
139532|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139533|NCT01610167|E3|Reported Event|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139534|NCT01610167|E2|Reported Event|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139535|NCT01610167|E1|Reported Event|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
139536|NCT01610154|B1|Baseline|Sitagliptin Treatment|Sitagliptin 100 mg QD for 12 weeks
139537|NCT01610154|P1|Participant Flow|Sitagliptin Treatment|Sitagliptin 100 mg QD for 12 weeks
139538|NCT01610154|O2|Outcome|Obese Group|BMI≥25 kg/m2
139539|NCT01610154|O1|Outcome|Non-obese Group|BMI<25 kg/m2
139540|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
139541|NCT01610154|O2|Outcome|Obese Group|BMI≥25 kg/m2
139542|NCT01610154|O1|Outcome|Non-obese Group|BMI<25 kg/m2
139543|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
139544|NCT01610154|O2|Outcome|Obese Group|BMI≥25 kg/m2
139545|NCT01610154|O1|Outcome|Non-obese Group|BMI<25 kg/m2
139546|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
139547|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
139548|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
139549|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
139550|NCT01610154|E1|Reported Event|Sitagliptin Treatment|Sitagliptin 100 mg QD
139551|NCT01610076|B3|Baseline|Total|Total of all reporting groups
139552|NCT01610076|B2|Baseline|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration
Code Status Video: 10 minute video about Code Status"
139553|NCT01610076|B1|Baseline|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
139554|NCT01610076|P2|Participant Flow|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration
Code Status Video: 10 minute video about Code Status"
139555|NCT01610076|P1|Participant Flow|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
139556|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration
Code Status Video: 10 minute video about Code Status"
139557|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration
Code Status Video: 10 minute video about Code Status"
139558|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration
Code Status Video: 10 minute video about Code Status"
139559|NCT01610076|O2|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration
Code Status Video: 10 minute video about Code Status"
139560|NCT01610076|O1|Outcome|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
139561|NCT01610076|E2|Reported Event|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration
Code Status Video: 10 minute video about Code Status"
139565|NCT01610063|B1|Baseline|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
139566|NCT01610063|P2|Participant Flow|Unguided|Treatment as usual
139567|NCT01610063|P1|Participant Flow|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
139568|NCT01610063|O2|Outcome|Unguided|Treatment as usual
139569|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
139570|NCT01610063|O2|Outcome|Unguided|Treatment as usual
139571|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
139572|NCT01610063|O2|Outcome|Unguided|Treatment as usual
139573|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
139574|NCT01610063|O2|Outcome|Unguided|Treatment as usual
139575|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
139576|NCT01610063|O2|Outcome|Unguided|Treatment as usual
139577|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
139578|NCT01610063|O2|Outcome|Unguided|Treatment as usual
139579|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
139580|NCT01610063|O2|Outcome|Unguided|Treatment as usual
139581|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
139582|NCT01610063|O2|Outcome|Unguided|Treatment as usual
139583|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
139584|NCT01610063|E2|Reported Event|Unguided|Treatment as usual
139585|NCT01610063|E1|Reported Event|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
139586|NCT01610037|B4|Baseline|Total|Total of all reporting groups
139587|NCT01610037|B3|Baseline|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
141895|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
139595|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
139596|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139597|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139598|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
139599|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139600|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139601|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
139602|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139603|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139604|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
139605|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139606|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139607|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
139608|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139609|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139610|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
139611|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139612|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139613|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
139614|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139615|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139616|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
139617|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139618|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139619|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
139620|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139621|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139622|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
139623|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139624|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
139629|NCT01610037|E3|Reported Event|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
139630|NCT01610037|E2|Reported Event|Tiotropium|18 μg capsules for inhalation, o.d
139631|NCT01610037|E1|Reported Event|QVA 149|110/50 µg capsules for inhalation, o.d
139632|NCT01610011|B3|Baseline|Total|Total of all reporting groups
139633|NCT01610011|B2|Baseline|Glycine Administration GLDC Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.
Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
139634|NCT01610011|B1|Baseline|Glycine Administration|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.
Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
139635|NCT01610011|P2|Participant Flow|Glycine Administration GLDC Mutation Subjects|Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics. Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage.
139636|NCT01610011|P1|Participant Flow|Glycine Administration|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.
Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
139637|NCT01610011|O2|Outcome|Glycine Administration GLDC Mutation Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.
Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
139638|NCT01610011|O1|Outcome|Glycine Administration Controls|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.
Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
139639|NCT01610011|E2|Reported Event|Glycine Administration GLDC Mutation Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.
Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
139640|NCT01610011|E1|Reported Event|Glycine Administration Controls|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.
Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
139642|NCT01609790|B3|Baseline|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139643|NCT01609790|B2|Baseline|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
139644|NCT01609790|B1|Baseline|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139645|NCT01609790|P3|Participant Flow|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139646|NCT01609790|P2|Participant Flow|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
139647|NCT01609790|P1|Participant Flow|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139648|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139649|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
139650|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139651|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
139652|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139653|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
139654|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139655|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
139656|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139657|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
139658|NCT01609790|O1|Outcome|Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139659|NCT01609790|E3|Reported Event|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139702|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139660|NCT01609790|E2|Reported Event|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
139661|NCT01609790|E1|Reported Event|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
139662|NCT01609582|B3|Baseline|Total|Total of all reporting groups
139663|NCT01609582|B2|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
139664|NCT01609582|B1|Baseline|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
139665|NCT01609582|P2|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
139666|NCT01609582|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
139667|NCT01609582|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
139668|NCT01609582|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
139669|NCT01609582|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
139670|NCT01609582|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
139671|NCT01609582|E2|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
139672|NCT01609582|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
139673|NCT01609543|B1|Baseline|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
139674|NCT01609543|P1|Participant Flow|Erlotinib Hydrochloride|Participants received a single 150 milligrams (mg) oral dose of erlotinib hydrochloride (Tarceva) tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
139675|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
139676|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
139677|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity, or consent withdrawal, whichever occurred first up to 34 months.
139678|NCT01609543|E1|Reported Event|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
139679|NCT01609478|B4|Baseline|Total|Total of all reporting groups
139680|NCT01609478|B3|Baseline|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139681|NCT01609478|B2|Baseline|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139682|NCT01609478|B1|Baseline|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139683|NCT01609478|P3|Participant Flow|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139684|NCT01609478|P2|Participant Flow|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139685|NCT01609478|P1|Participant Flow|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139686|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139687|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139688|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139689|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139690|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139691|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139692|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139693|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139694|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139695|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139696|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139697|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139698|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139699|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139700|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139701|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139703|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139704|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139705|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139706|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139707|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139708|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139709|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139710|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139711|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139712|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139713|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139714|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139715|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139716|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139717|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139718|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139719|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139720|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139721|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139722|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139723|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139724|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139725|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139726|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139727|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139728|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139729|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139730|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139731|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139732|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139733|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139734|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139735|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139736|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139737|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139738|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139739|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139740|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139741|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139742|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139743|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139744|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139745|NCT01609478|E3|Reported Event|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139746|NCT01609478|E2|Reported Event|Indacaterol Acetate 150 mcg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139747|NCT01609478|E1|Reported Event|Indacaterol Acetate 75 mcg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
139750|NCT01609257|B1|Baseline|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139751|NCT01609257|P2|Participant Flow|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139752|NCT01609257|P1|Participant Flow|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139753|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139754|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139755|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139756|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139757|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139758|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139759|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139760|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139761|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139762|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139763|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139764|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139765|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139766|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139767|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139768|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139769|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139770|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139771|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139772|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139773|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139774|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139775|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139776|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139777|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139778|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139779|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139780|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139781|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139782|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139783|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139784|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139785|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139786|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139787|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139788|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139789|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139790|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139791|NCT01609257|O2|Outcome|Placebo_Not Infected|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139792|NCT01609257|O1|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139793|NCT01609257|O2|Outcome|Placebo_Not Ill|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139794|NCT01609257|O1|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139795|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139796|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139797|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139798|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139799|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139800|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139801|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139802|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139803|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139804|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139805|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139806|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139807|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139808|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139809|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139810|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139811|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139812|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139813|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139814|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139815|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139816|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139817|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139818|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139819|NCT01609257|E2|Reported Event|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
139820|NCT01609257|E1|Reported Event|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
139821|NCT01609062|B3|Baseline|Total|Total of all reporting groups
139822|NCT01609062|B2|Baseline|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139823|NCT01609062|B1|Baseline|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139824|NCT01609062|P2|Participant Flow|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139825|NCT01609062|P1|Participant Flow|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139826|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139827|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139828|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139829|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139830|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139831|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139832|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139833|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
145191|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
139834|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139835|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139836|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139837|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139838|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139839|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139840|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139841|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139842|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139843|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139844|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139845|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139846|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139847|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139848|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139849|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139850|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139851|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139852|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139853|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139854|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139855|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139856|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139857|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139858|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139859|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139860|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139861|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139862|NCT01609062|O3|Outcome|All Subjects|Both groups combined
139863|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139864|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139865|NCT01609062|E2|Reported Event|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139866|NCT01609062|E1|Reported Event|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
139867|NCT01609023|B1|Baseline|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
139868|NCT01609023|P1|Participant Flow|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
139869|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
139870|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
139871|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
139872|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
139929|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139873|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
139874|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
139875|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
139876|NCT01609023|E1|Reported Event|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
139877|NCT01609010|B3|Baseline|Total|Total of all reporting groups
139878|NCT01609010|B2|Baseline|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139879|NCT01609010|B1|Baseline|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139880|NCT01609010|P2|Participant Flow|Rituximab + Interferon (IFN)|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-alpha2a (IFN-α2a), 3 million international units per day (MIU/day), subcutaneously (SC), during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139881|NCT01609010|P1|Participant Flow|Rituximab Monotherapy|Participants rituximab received 375 milligrams per square meter (mg/m^2), intravenously (IV), once weekly for 4 weeks. Participants who achieved minor response (MR), partial response (PR), or complete response (CR) after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139882|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139883|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139906|NCT01608971|B1|Baseline|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
139907|NCT01608971|P2|Participant Flow|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
139884|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139885|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139886|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139887|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139888|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139889|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139890|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139891|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139892|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139893|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139894|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
140887|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
139895|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139896|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139897|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139898|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139899|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139900|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139901|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139902|NCT01609010|E2|Reported Event|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139903|NCT01609010|E1|Reported Event|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
139904|NCT01608971|B3|Baseline|Total|Total of all reporting groups
139905|NCT01608971|B2|Baseline|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
141896|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
139908|NCT01608971|P1|Participant Flow|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
139909|NCT01608971|O2|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
139910|NCT01608971|O1|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
139911|NCT01608971|O2|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
139912|NCT01608971|O1|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
139913|NCT01608971|O2|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
139914|NCT01608971|O1|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
139915|NCT01608971|O2|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
139916|NCT01608971|O1|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
139917|NCT01608971|E2|Reported Event|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
139918|NCT01608971|E1|Reported Event|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
139919|NCT01608815|B4|Baseline|Total|Total of all reporting groups
139920|NCT01608815|B3|Baseline|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139921|NCT01608815|B2|Baseline|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139922|NCT01608815|B1|Baseline|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139923|NCT01608815|P3|Participant Flow|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139924|NCT01608815|P2|Participant Flow|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139925|NCT01608815|P1|Participant Flow|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139926|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139927|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139928|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139930|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139931|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139932|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139933|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139934|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139935|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139936|NCT01608815|O2|Outcome|Dolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139937|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
139938|NCT01608815|E3|Reported Event|Children (Group 3)|Participants 2 to 11 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
139939|NCT01608815|E2|Reported Event|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
139940|NCT01608815|E1|Reported Event|Adults (Group 1)|Participants ≥18 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
139941|NCT01608724|B1|Baseline|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
139942|NCT01608724|P1|Participant Flow|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
139943|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
139944|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
139945|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
139946|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
139947|NCT01608724|E1|Reported Event|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
139948|NCT01608672|B1|Baseline|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
139949|NCT01608672|P1|Participant Flow|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
139950|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
139951|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
139952|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
141897|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
139953|NCT01608672|E1|Reported Event|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
139954|NCT01608659|B1|Baseline|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
139955|NCT01608659|P1|Participant Flow|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
139956|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
139957|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
139958|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
139959|NCT01608659|E1|Reported Event|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
139960|NCT01608490|B3|Baseline|Total|Total of all reporting groups
139961|NCT01608490|B2|Baseline|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
139962|NCT01608490|B1|Baseline|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
139963|NCT01608490|P2|Participant Flow|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
139964|NCT01608490|P1|Participant Flow|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
139965|NCT01608490|O2|Outcome|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
140028|NCT01608100|O1|Outcome|Specificity in K2 EDTA|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
145192|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
139966|NCT01608490|O1|Outcome|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
139967|NCT01608490|O2|Outcome|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
139968|NCT01608490|O1|Outcome|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
139969|NCT01608490|E2|Reported Event|Control Arm is Standard Medical Care|The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
139970|NCT01608490|E1|Reported Event|RePneu Lung Volume Reduction Coil System|"The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use."
139971|NCT01608321|B3|Baseline|Total|Total of all reporting groups
139972|NCT01608321|B2|Baseline|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.
Sham device: Placebo Device that simulates active rTMS treatment"
139973|NCT01608321|B1|Baseline|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.
rTMS: Repetitive Transcranial Magnetic Stimulation"
139974|NCT01608321|P2|Participant Flow|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.
Sham device: Placebo Device that simulates active rTMS treatment"
140218|NCT01607450|P1|Participant Flow|Lean Placebo|"12 hour placebo (saline) infusion prior to PET study
Placebo: Saline placebo infusion for 12 hours prior to PET study"
139975|NCT01608321|P1|Participant Flow|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.
rTMS: Repetitive Transcranial Magnetic Stimulation"
139976|NCT01608321|O2|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.
Sham device: Placebo Device that simulates active rTMS treatment"
139977|NCT01608321|O1|Outcome|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.
rTMS: Repetitive Transcranial Magnetic Stimulation"
139978|NCT01608321|E2|Reported Event|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.
Sham device: Placebo Device that simulates active rTMS treatment"
139979|NCT01608321|E1|Reported Event|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.
rTMS: Repetitive Transcranial Magnetic Stimulation"
139980|NCT01608308|B3|Baseline|Total|Total of all reporting groups
139981|NCT01608308|B2|Baseline|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
139982|NCT01608308|B1|Baseline|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
139983|NCT01608308|P2|Participant Flow|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
139984|NCT01608308|P1|Participant Flow|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
140029|NCT01608100|O3|Outcome|Sensitivity in Serum Separator|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
140252|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
145193|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
139985|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
139986|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
139987|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
139988|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
139989|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
139990|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
140219|NCT01607450|O7|Outcome|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
139991|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
139992|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
139993|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
139994|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
139995|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
139996|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
139997|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
140030|NCT01608100|O2|Outcome|Sensitivity in Lithium Heparin Separator|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
145194|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
139998|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
139999|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
140000|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
140001|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
140002|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
140003|NCT01608308|E2|Reported Event|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
140004|NCT01608308|E1|Reported Event|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
140005|NCT01608295|B3|Baseline|Total|Total of all reporting groups
140006|NCT01608295|B2|Baseline|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
140007|NCT01608295|B1|Baseline|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
140008|NCT01608295|P2|Participant Flow|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
140009|NCT01608295|P1|Participant Flow|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
140253|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study
Placebo: Saline placebo infusion for 12 hours prior to PET study"
140010|NCT01608295|O2|Outcome|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
140011|NCT01608295|O1|Outcome|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
140012|NCT01608295|O2|Outcome|Paroxetine; Paxil|Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
140013|NCT01608295|O1|Outcome|Vilazodone; Viibryd|Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
140014|NCT01608295|O2|Outcome|Paroxetine; Paxil|Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
140015|NCT01608295|O1|Outcome|Vilazodone; Viibryd|Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
140220|NCT01607450|O6|Outcome|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
140016|NCT01608295|E2|Reported Event|Paroxetine; Paxil|Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
140017|NCT01608295|E1|Reported Event|Vilazodone; Viibryd|Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
140018|NCT01608100|B1|Baseline|ARCHITECT STAT High Sensitive Troponin I Assay Testing|All subjects will have their blood tested by the investigational ARCHITECT STAT High Sensitive Troponin I assay. Specimens were collected at 11 emergency departments from 1,101 subjects presenting to the emergency department with symptoms consistent with acute coronary syndrome (ACS). All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care.
140019|NCT01608100|P1|Participant Flow|ARCHITECT STAT High Sensitive Troponin I Assay Testing|"All subjects will have their blood tested by the investigational Troponin I assay.
ARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.
Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.
Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit."
140020|NCT01608100|O3|Outcome|Positive Predictive Value in Serum Separator|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
140021|NCT01608100|O2|Outcome|Positive Predictive Value in Lithium Heparin Separator|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
140022|NCT01608100|O1|Outcome|Positive Predictive Value in K2 EDTA|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
140023|NCT01608100|O3|Outcome|Negative Predictive Value in Serum Separator|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
140024|NCT01608100|O2|Outcome|Negative Predictive Value in Lithium Heparin Separator|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
140025|NCT01608100|O1|Outcome|Negative Predictive Value in K2 EDTA|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
140026|NCT01608100|O3|Outcome|Specificity in Serum Separator|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
140027|NCT01608100|O2|Outcome|Specificity in Lithium Heparin Separator|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
140254|NCT01607450|E7|Reported Event|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
145195|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
140031|NCT01608100|O1|Outcome|Sensitivity in K2 EDTA|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
140032|NCT01608100|O6|Outcome|90-day Prognosis for Serum Separator Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
140033|NCT01608100|O5|Outcome|30-day Prognosis for Serum Separator Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
140034|NCT01608100|O4|Outcome|90-day Prognosis for Lithium Heparin Separator Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
140035|NCT01608100|O3|Outcome|30-day Prognosis for Lithium Heparin Separator Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
140036|NCT01608100|O2|Outcome|90-day Prognosis for K2 EDTA Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
140037|NCT01608100|O1|Outcome|30-day Prognosis for K2 EDTA Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
140038|NCT01608100|O3|Outcome|Area Under the Curve in Serum Separator|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
140039|NCT01608100|O2|Outcome|Area Under the Curve in Lithium Heparin Separator|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
140040|NCT01608100|O1|Outcome|Area Under the Curve in K2 EDTA|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
140062|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140221|NCT01607450|O5|Outcome|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140041|NCT01608100|E1|Reported Event|ARCHITECT STAT High Sensitive Troponin I Assay Testing|"All subjects will have their blood tested by the investigational Troponin I assay.
ARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.
Results obtained will be used to assess the prognosis of subjects with a troponin result for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.
Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit."
140042|NCT01607853|B1|Baseline|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140043|NCT01607853|P1|Participant Flow|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140044|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140045|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140046|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140047|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140048|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140049|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140050|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140051|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140052|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140053|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
145196|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
140054|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140055|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140056|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140057|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140058|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140059|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140060|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140061|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140216|NCT01607450|P3|Participant Flow|Type 2 DM GLP-1 Mid-Range Dose|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140063|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140064|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140065|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140066|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140067|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140068|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140069|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140070|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140071|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140072|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140073|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140074|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140075|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140076|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140077|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140150|NCT01607645|B2|Baseline|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140078|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140079|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140080|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140081|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140082|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140083|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140084|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140085|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140086|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140087|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140088|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140089|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140090|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140091|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140092|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140093|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140094|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140095|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140096|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140097|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140098|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140099|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140100|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140101|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140176|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140102|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140103|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140104|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140105|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140106|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140107|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140108|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140109|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140110|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140111|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140112|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140113|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140114|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140115|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140116|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140117|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140118|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140119|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140120|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140121|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140122|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140123|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140124|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140125|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140250|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140888|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140126|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140127|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140128|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140129|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140130|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140131|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140132|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140133|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140134|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140135|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140136|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140137|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140138|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140139|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140140|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140141|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140142|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140143|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140144|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140145|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140146|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140147|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140148|NCT01607853|E1|Reported Event|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
140149|NCT01607645|B3|Baseline|Total|Total of all reporting groups
140251|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140151|NCT01607645|B1|Baseline|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140152|NCT01607645|P2|Participant Flow|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140153|NCT01607645|P1|Participant Flow|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140154|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140155|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140156|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140157|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140158|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140159|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140160|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140161|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140162|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140163|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140164|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140165|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140166|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140167|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140168|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140169|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140170|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140171|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140172|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140173|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140174|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140175|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
145197|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
140177|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140178|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140179|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140180|NCT01607645|E2|Reported Event|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140181|NCT01607645|E1|Reported Event|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.
decitabine: Given IV
idarubicin: Given IV
cytarabine: Given IV"
140182|NCT01607593|B1|Baseline|SERTRALINE|Participants with PTSD who were treated with sertraline as instructed by physicians.
140183|NCT01607593|P1|Participant Flow|SERTRALINE|Participants with post-traumatic stress disorder (PTSD) who were treated with sertraline as instructed by physicians
140184|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
140185|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
140186|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
140187|NCT01607593|E1|Reported Event|SERTRALINE|Participants with PTSD who were treated with sertraline as instructed by physicians
140188|NCT01607476|B4|Baseline|Total|Total of all reporting groups
140217|NCT01607450|P2|Participant Flow|Lean GLP-1 Mid-Range Dose|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140189|NCT01607476|B3|Baseline|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140190|NCT01607476|B2|Baseline|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140191|NCT01607476|B1|Baseline|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).
Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140192|NCT01607476|P3|Participant Flow|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140193|NCT01607476|P2|Participant Flow|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140194|NCT01607476|P1|Participant Flow|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable Alzheimer's disease (AD) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 Pittsburgh Compound B (PiB) PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 millicurie (mCi) C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140195|NCT01607476|O3|Outcome|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140196|NCT01607476|O2|Outcome|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140197|NCT01607476|O1|Outcome|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).
Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140198|NCT01607476|O3|Outcome|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140199|NCT01607476|O2|Outcome|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140200|NCT01607476|O1|Outcome|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).
Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140201|NCT01607476|E3|Reported Event|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140889|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140202|NCT01607476|E2|Reported Event|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140203|NCT01607476|E1|Reported Event|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).
Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
140204|NCT01607450|B8|Baseline|Total|Total of all reporting groups
140205|NCT01607450|B7|Baseline|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
140206|NCT01607450|B6|Baseline|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
140207|NCT01607450|B5|Baseline|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140208|NCT01607450|B4|Baseline|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140209|NCT01607450|B3|Baseline|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140210|NCT01607450|B2|Baseline|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140211|NCT01607450|B1|Baseline|Lean Saline|"12 hour placebo (saline) infusion prior to PET study
Placebo: Saline placebo infusion for 12 hours prior to PET study"
140212|NCT01607450|P7|Participant Flow|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140213|NCT01607450|P6|Participant Flow|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
140214|NCT01607450|P5|Participant Flow|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140215|NCT01607450|P4|Participant Flow|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140222|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140223|NCT01607450|O3|Outcome|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140224|NCT01607450|O2|Outcome|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140225|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study
Placebo: Saline placebo infusion for 12 hours prior to PET study"
140226|NCT01607450|O7|Outcome|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
140227|NCT01607450|O6|Outcome|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
140228|NCT01607450|O5|Outcome|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140229|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140230|NCT01607450|O3|Outcome|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140231|NCT01607450|O2|Outcome|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140232|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study
Placebo: Saline placebo infusion for 12 hours prior to PET study"
140233|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
140234|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
140235|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140236|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140237|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140238|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140239|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study
Placebo: Saline placebo infusion for 12 hours prior to PET study"
140240|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
140241|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
140242|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140243|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140244|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140245|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140246|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study
Placebo: Saline placebo infusion for 12 hours prior to PET study"
140247|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
140248|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
140249|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140255|NCT01607450|E6|Reported Event|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
140256|NCT01607450|E5|Reported Event|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140257|NCT01607450|E4|Reported Event|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
140258|NCT01607450|E3|Reported Event|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140259|NCT01607450|E2|Reported Event|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
140260|NCT01607450|E1|Reported Event|Lean Saline|"12 hour placebo (saline) infusion prior to PET study
Placebo: Saline placebo infusion for 12 hours prior to PET study"
140261|NCT01607411|B1|Baseline|Overall|All randomized participants who received atleast one dose of the study treatments
140262|NCT01607411|P4|Participant Flow|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140263|NCT01607411|P3|Participant Flow|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140264|NCT01607411|P2|Participant Flow|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140265|NCT01607411|P1|Participant Flow|Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 grams (g) ± 0.1g of NaF toothpaste(1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140266|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140267|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
141485|NCT01603043|B2|Baseline|Sham Injection|1 mock injection per month for 12 months
140268|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140269|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140270|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140271|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140272|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140273|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140274|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140275|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140276|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140277|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140278|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
145198|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
140279|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140280|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140281|NCT01607411|E4|Reported Event|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140282|NCT01607411|E3|Reported Event|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140283|NCT01607411|E2|Reported Event|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140284|NCT01607411|E1|Reported Event|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
140285|NCT01607398|B3|Baseline|Total|Total of all reporting groups
140286|NCT01607398|B2|Baseline|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140287|NCT01607398|B1|Baseline|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140288|NCT01607398|P2|Participant Flow|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140289|NCT01607398|P1|Participant Flow|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140290|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140291|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140292|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140293|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140294|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140295|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140296|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140297|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140298|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140299|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140300|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140301|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140357|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140302|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140303|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140304|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140305|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140306|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140307|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140308|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140309|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140310|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140311|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140335|NCT01607320|O1|Outcome|All Study Participants|The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
140312|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140313|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140314|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140315|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140316|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140317|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140318|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140319|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140320|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140321|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140322|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140323|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140324|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140325|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140430|NCT01606735|B1|Baseline|342 mcg|IBI-10090: dexamethasone
140431|NCT01606735|P3|Participant Flow|697 mcg|IBI-10090: dexamethasone
140326|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140327|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140328|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140329|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140330|NCT01607398|E2|Reported Event|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140331|NCT01607398|E1|Reported Event|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
140332|NCT01607320|B1|Baseline|All Study Participants|Participants were randomized to receive one of the two following interventions, but the study was terminated and data will not be unblinded: 1) 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 with Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal; or 2) 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 with Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
140333|NCT01607320|P2|Participant Flow|Clomiphene|"3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7
Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal"
140334|NCT01607320|P1|Participant Flow|Raloxifene|"3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7
Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal"
140336|NCT01607320|E1|Reported Event|All Study Participants|The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
140337|NCT01607203|B3|Baseline|Total|Total of all reporting groups
140338|NCT01607203|B2|Baseline|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
140339|NCT01607203|B1|Baseline|HCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
140340|NCT01607203|P2|Participant Flow|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
140341|NCT01607203|P1|Participant Flow|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
140342|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
140343|NCT01607203|O1|Outcome|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
140344|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
140345|NCT01607203|O1|Outcome|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
140346|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
140347|NCT01607203|O1|Outcome|hCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
140348|NCT01607203|E2|Reported Event|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
140349|NCT01607203|E1|Reported Event|hCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
140350|NCT01607112|B3|Baseline|Total|Total of all reporting groups
140351|NCT01607112|B2|Baseline|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140352|NCT01607112|B1|Baseline|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140353|NCT01607112|P2|Participant Flow|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140354|NCT01607112|P1|Participant Flow|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140355|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140356|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140432|NCT01606735|P2|Participant Flow|517 mcg|IBI-10090: dexamethasone
140433|NCT01606735|P1|Participant Flow|342 mcg|IBI-10090: dexamethasone
140358|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140359|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140360|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140361|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140362|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140363|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140364|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140365|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140366|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140367|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140368|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140453|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed"
140369|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140370|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140371|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140372|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140373|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140374|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140375|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140376|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140377|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140378|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140379|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140380|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140381|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140382|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140383|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140434|NCT01606735|O3|Outcome|697 mcg|IBI-10090: dexamethasone
140435|NCT01606735|O2|Outcome|517 mcg|IBI-10090: dexamethasone
140384|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140385|NCT01607112|E2|Reported Event|Elderly Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140386|NCT01607112|E1|Reported Event|Adult Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
140387|NCT01606800|B3|Baseline|Total|Total of all reporting groups
140388|NCT01606800|B2|Baseline|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
140389|NCT01606800|B1|Baseline|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
140390|NCT01606800|P2|Participant Flow|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
140391|NCT01606800|P1|Participant Flow|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
140392|NCT01606800|O2|Outcome|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
140393|NCT01606800|O1|Outcome|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
140394|NCT01606800|E2|Reported Event|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
140395|NCT01606800|E1|Reported Event|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
140396|NCT01606748|B3|Baseline|Total|Total of all reporting groups
140397|NCT01606748|B2|Baseline|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140398|NCT01606748|B1|Baseline|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140399|NCT01606748|P2|Participant Flow|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 2 received necitumumab drug product manufactured using a new and comparable necitumumab drug substance (Process D drug product).
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140400|NCT01606748|P1|Participant Flow|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (IV) infusion at an absolute dose of 800 milligrams (mg). Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/square meter (m2).
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140401|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
140402|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-in|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
140403|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
140404|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 PK Run-In|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
140405|NCT01606748|O2|Outcome|Cisplatin Cohort 1 Day 1, Cycle 1, Combination|Cisplatin administered 75 mg/m2 on Days 1 and 8 of every 3-week cycle as an IV infusion.
140406|NCT01606748|O1|Outcome|Cisplatin Cohort 1 Day 1 Run-in|Cisplatin administered on Day 1 of the 3-week PK run-in period as an IV infusion of 75 mg/m2.
140407|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140436|NCT01606735|O1|Outcome|342 mcg|IBI-10090: dexamethasone
140437|NCT01606735|E3|Reported Event|697 mcg|IBI-10090: dexamethasone
140438|NCT01606735|E2|Reported Event|517 mcg|IBI-10090: dexamethasone
140439|NCT01606735|E1|Reported Event|342 mcg|IBI-10090: dexamethasone
140408|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140409|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
140410|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-in|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
140411|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140412|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140413|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140454|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed"
140455|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed"
140414|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140415|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140416|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140417|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
140418|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 Run-In|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
140419|NCT01606748|O2|Outcome|Cisplatin Cohort 1 Day 1, Cycle 1, Combination|Cisplatin administered 75 mg/m2 on Days 1 and 8 of every 3-week cycle as an IV infusion.
140420|NCT01606748|O1|Outcome|Cisplatin Cohort 1 Day 1 Run-in|Cisplatin administered on Day 1 of the 3-week PK run-in period as an IV infusion of 75 mg/m2.
140421|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
140422|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-In|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
140423|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
140424|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 Run-in|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
140425|NCT01606748|E2|Reported Event|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140426|NCT01606748|E1|Reported Event|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
140427|NCT01606735|B4|Baseline|Total|Total of all reporting groups
140428|NCT01606735|B3|Baseline|697 mcg|IBI-10090: dexamethasone
140429|NCT01606735|B2|Baseline|517 mcg|IBI-10090: dexamethasone
140440|NCT01606670|B1|Baseline|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
140441|NCT01606670|P1|Participant Flow|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
140442|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
140443|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
140444|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
140445|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
140446|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
140447|NCT01606670|E1|Reported Event|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
140448|NCT01606319|B3|Baseline|Total|Total of all reporting groups
140449|NCT01606319|B2|Baseline|Ibuprofen|"ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed"
140450|NCT01606319|B1|Baseline|Acetaminophen|"acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed"
140451|NCT01606319|P2|Participant Flow|Ibuprofen|"ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed"
140452|NCT01606319|P1|Participant Flow|Acetaminophen|"acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed"
140456|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed"
140457|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed"
140458|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed"
140459|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed"
140460|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed"
140461|NCT01606319|E2|Reported Event|Ibuprofen|"ibuprofen given as needed for pain or fever
Ibuprofen: 9.4 mg/kg every 6 hours as needed"
140462|NCT01606319|E1|Reported Event|Acetaminophen|"acetaminophen given as needed for pain or fever
Acetaminophen: 15 mg/kg every 6 hours as needed"
140463|NCT01606306|B7|Baseline|Total|Total of all reporting groups
140464|NCT01606306|B6|Baseline|Crossover Sequence 6|as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
140465|NCT01606306|B5|Baseline|Crossover Sequence 5|as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
140466|NCT01606306|B4|Baseline|Crossover Sequence 4|daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
140467|NCT01606306|B3|Baseline|Crossover Sequence 3|daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
140468|NCT01606306|B2|Baseline|Crossover Sequence 2|daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
140469|NCT01606306|B1|Baseline|Crossover Sequence 1|daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
140470|NCT01606306|P6|Participant Flow|Crossover Sequence 6|as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
140471|NCT01606306|P5|Participant Flow|Crossover Sequence 5|as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
140472|NCT01606306|P4|Participant Flow|Crossover Sequence 4|daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
140473|NCT01606306|P3|Participant Flow|Crossover Sequence 3|daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
140474|NCT01606306|P2|Participant Flow|Crossover Sequence 2|daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
140475|NCT01606306|P1|Participant Flow|Crossover Sequence 1|daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
140476|NCT01606306|O1|Outcome|All Evaluable Participants|Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period. Because placebo washouts were not performed, the data collected during the first two weeks of each period were not included in the analysis of ACDs. Days with missing diary data were also excluded from ACD determination.
140477|NCT01606306|E3|Reported Event|Daily LTRA|Daily leukotriene receptor antagonist (LTRA) treatment
140478|NCT01606306|E2|Reported Event|As-needed ICS|As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.
140479|NCT01606306|E1|Reported Event|Daily ICS|Daily inhaled corticosteroid (ICS) treatment
140480|NCT01606254|B5|Baseline|Total|Total of all reporting groups
140481|NCT01606254|B4|Baseline|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140482|NCT01606254|B3|Baseline|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140483|NCT01606254|B2|Baseline|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140484|NCT01606254|B1|Baseline|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140485|NCT01606254|P4|Participant Flow|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140486|NCT01606254|P3|Participant Flow|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140487|NCT01606254|P2|Participant Flow|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140488|NCT01606254|P1|Participant Flow|Paliperidone Palmitate 50 mg|Paliperidone palmitate (JNS010) 50 milligram (mg) intramuscular (into the muscle) injection administered on Days 1, 8, 36 and 64.
140489|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140490|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140491|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140492|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140493|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140494|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140495|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140496|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140497|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140498|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140499|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140500|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140501|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140502|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140503|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140504|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140505|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140506|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140507|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140508|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140509|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140510|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140511|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140512|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140513|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140514|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140515|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140516|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140517|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140518|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140519|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140520|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140665|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140521|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140522|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140523|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140524|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140525|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140526|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140527|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140528|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140529|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140530|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140531|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140532|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140533|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140534|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140535|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140536|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140537|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140538|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140539|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140540|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140541|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140542|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140543|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140544|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140545|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140546|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140547|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140548|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140549|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140550|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140551|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140552|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140553|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140554|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140555|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140556|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140557|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140558|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140559|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140560|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140561|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140562|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140563|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140564|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140565|NCT01606254|E4|Reported Event|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
140566|NCT01606254|E3|Reported Event|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
140567|NCT01606254|E2|Reported Event|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
140568|NCT01606254|E1|Reported Event|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
140569|NCT01606228|B1|Baseline|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140570|NCT01606228|P1|Participant Flow|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140571|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140572|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140573|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140574|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
141486|NCT01603043|B1|Baseline|AL-78898A|1 intravitreal injection per month for up to 12 months
140575|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140576|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140577|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140578|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140579|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140580|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140581|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140582|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140583|NCT01606228|E1|Reported Event|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
140584|NCT01606202|B3|Baseline|Total|Total of all reporting groups
140585|NCT01606202|B2|Baseline|Placebo|Placebo control.
140586|NCT01606202|B1|Baseline|GW-1000-02|Active treatment.
140587|NCT01606202|P2|Participant Flow|Placebo|Placebo control.The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
140588|NCT01606202|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg).
140589|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140590|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140591|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140592|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140593|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140594|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140595|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140596|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140597|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140704|NCT01606137|B1|Baseline|GW-1000-02|Active treatment
145199|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
140598|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140599|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140600|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140601|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140602|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140603|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140604|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140605|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140606|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140607|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140608|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140609|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140610|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140611|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140612|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140613|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140614|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140615|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140616|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140617|NCT01606202|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140618|NCT01606202|E1|Reported Event|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
140619|NCT01606189|B1|Baseline|All Study Treatments: GW-1000-02, GW-2000-02 and Placebo|As this was a crossover study design, all patients were to receive all study treatments: GW-1000-02, GW-2000-02 and placebo.
140620|NCT01606189|P6|Participant Flow|GW-2000-02 First, Then Placebo, Then GW-1000-02|"GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
140621|NCT01606189|P5|Participant Flow|Placebo First, Then GW-2000-02, Then GW-1000-02|"Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
140622|NCT01606189|P4|Participant Flow|GW-1000-02 First, Then Placebo, Then GW-2000-02|"GW-1000-02 first (14-20 days), then placebo (14-20 days), then GW-2000-02 (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
140623|NCT01606189|P3|Participant Flow|Placebo First, Then GW-1000-02, Then GW-2000-02|"Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
140624|NCT01606189|P2|Participant Flow|GW-2000-02 First, Then GW-1000-02, Then Placebo|"GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
140664|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140625|NCT01606189|P1|Participant Flow|GW-1000-02 First, Then GW-2000-02, Then Placebo|"GW-1000-02 first (14-20 days), then GW-2000-02 (14-20 days), then placebo (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
140626|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140627|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
140628|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
140629|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140630|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
140631|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
140632|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140633|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
140634|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
140635|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140636|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
140637|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
141487|NCT01603043|P2|Participant Flow|Sham Injection|1 mock injection per month for 12 months
140638|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140639|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
140640|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
140641|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140642|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
140643|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
140644|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140645|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
140646|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
140647|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140648|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
140649|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
140650|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140651|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
140652|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
140653|NCT01606189|E3|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
140654|NCT01606189|E2|Reported Event|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
140655|NCT01606189|E1|Reported Event|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
140656|NCT01606176|B3|Baseline|Total|Total of all reporting groups
140657|NCT01606176|B2|Baseline|Placebo|Placebo control.
140658|NCT01606176|B1|Baseline|GW-1000-02|Active treatment.
140659|NCT01606176|P2|Participant Flow|Placebo|Placebo control. The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
140660|NCT01606176|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.5mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 120 mg : CBD 120 mg).
140661|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140662|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140663|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
145200|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
140666|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140667|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140668|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140669|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140670|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140671|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140672|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140673|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140674|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140675|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140676|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140677|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140678|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140679|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140680|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140681|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140682|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140683|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140684|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140685|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140686|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140687|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140688|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140689|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140690|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140691|NCT01606176|E2|Reported Event|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
140692|NCT01606176|E1|Reported Event|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
140693|NCT01606150|B3|Baseline|Total|Total of all reporting groups
140694|NCT01606150|B2|Baseline|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure
topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
140695|NCT01606150|B1|Baseline|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine
1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
140696|NCT01606150|P2|Participant Flow|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure
topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
140697|NCT01606150|P1|Participant Flow|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine
1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
140698|NCT01606150|O2|Outcome|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure
topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
140699|NCT01606150|O1|Outcome|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine
1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
140700|NCT01606150|O2|Outcome|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure
topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
140701|NCT01606150|O1|Outcome|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine
1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
140702|NCT01606150|E2|Reported Event|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure
topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
140703|NCT01606150|E1|Reported Event|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine
1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
140705|NCT01606137|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg).
140706|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140707|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140708|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140709|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140710|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140711|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140712|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140713|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140714|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140715|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140716|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
141488|NCT01603043|P1|Participant Flow|AL-78898A|1 intravitreal injection per month for up to 12 months
140717|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140718|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140719|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140720|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140721|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140722|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140723|NCT01606137|E1|Reported Event|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
140724|NCT01606007|B4|Baseline|Total|Total of all reporting groups
140725|NCT01606007|B3|Baseline|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
140726|NCT01606007|B2|Baseline|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
140727|NCT01606007|B1|Baseline|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
140728|NCT01606007|P3|Participant Flow|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
140729|NCT01606007|P2|Participant Flow|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
140730|NCT01606007|P1|Participant Flow|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
140731|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
140732|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
140733|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
140762|NCT01605916|B3|Baseline|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140734|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
140735|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
140736|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
140737|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
140738|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
140739|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
140740|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
141489|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
140741|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
140742|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
140743|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
140744|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
140745|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
140746|NCT01606007|E3|Reported Event|SAXA + DAPA + MET|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
140747|NCT01606007|E2|Reported Event|DAPA + MET|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
140748|NCT01606007|E1|Reported Event|SAXA + MET|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
140749|NCT01605942|B3|Baseline|Total|Total of all reporting groups
140750|NCT01605942|B2|Baseline|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
140751|NCT01605942|B1|Baseline|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
140752|NCT01605942|P2|Participant Flow|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
140753|NCT01605942|P1|Participant Flow|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
140754|NCT01605942|O1|Outcome|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
140755|NCT01605942|O2|Outcome|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
140756|NCT01605942|O1|Outcome|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
140757|NCT01605942|E2|Reported Event|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
140758|NCT01605942|E1|Reported Event|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
140759|NCT01605916|B6|Baseline|Total|Total of all reporting groups
140760|NCT01605916|B5|Baseline|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140761|NCT01605916|B4|Baseline|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140881|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140763|NCT01605916|B2|Baseline|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140764|NCT01605916|B1|Baseline|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140765|NCT01605916|P5|Participant Flow|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140766|NCT01605916|P4|Participant Flow|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140767|NCT01605916|P3|Participant Flow|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140768|NCT01605916|P2|Participant Flow|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140769|NCT01605916|P1|Participant Flow|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140770|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140771|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140838|NCT01605916|E3|Reported Event|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140772|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140773|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140774|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140775|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140776|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140777|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140778|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140779|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140780|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140781|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140782|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140783|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140784|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140785|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140786|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140787|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140788|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140789|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140790|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140791|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140792|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140793|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140794|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140882|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
145201|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
140795|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140796|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140797|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140798|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140799|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140800|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140801|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140802|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140803|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140804|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140805|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140806|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140807|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140808|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140809|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140810|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140811|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140812|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140813|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140814|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140815|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140816|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140817|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140818|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140819|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140820|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140821|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140822|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140823|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140824|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140825|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140826|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140827|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140828|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140883|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140884|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140829|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140830|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140831|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140832|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
140833|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
140834|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140835|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140836|NCT01605916|E5|Reported Event|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
140837|NCT01605916|E4|Reported Event|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
141490|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
140839|NCT01605916|E2|Reported Event|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140840|NCT01605916|E1|Reported Event|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
140841|NCT01605877|B1|Baseline|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
140842|NCT01605877|P1|Participant Flow|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
140843|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140844|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140845|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140846|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140847|NCT01605877|O2|Outcome|SN6AD2, as Measured With VCTS|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140848|NCT01605877|O1|Outcome|SN6AD2, as Measured With CSV-1000|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140849|NCT01605877|O5|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140850|NCT01605877|O4|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140851|NCT01605877|O3|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140852|NCT01605877|O2|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140853|NCT01605877|O1|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140854|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140855|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140856|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140857|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140858|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140859|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140860|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140861|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140862|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140863|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140864|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140865|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140866|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140867|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140868|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140869|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140870|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140871|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140872|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140873|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140874|NCT01605877|O4|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140875|NCT01605877|O3|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140876|NCT01605877|O2|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140877|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140878|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140879|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140880|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140890|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140891|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140892|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140893|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140894|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140895|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140896|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140897|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140898|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140899|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140900|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140901|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
140902|NCT01605877|E1|Reported Event|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
140903|NCT01605825|B3|Baseline|Total|Total of all reporting groups
140904|NCT01605825|B2|Baseline|Dalfampridine-ER/Placebo|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:
Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.
10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
141491|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
140905|NCT01605825|B1|Baseline|Placebo/Dalfampridine-ER|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:
Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.
10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
140906|NCT01605825|P2|Participant Flow|Dalfampridine-ER/Placebo|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:
Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.
10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
140907|NCT01605825|P1|Participant Flow|Placebo/Dalfampridine-ER|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:
Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.
10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
140908|NCT01605825|O2|Outcome|Dalfampridine-ER|
140909|NCT01605825|O1|Outcome|Placebo|
140910|NCT01605825|E2|Reported Event|Dalfampridine-ER|
140911|NCT01605825|E1|Reported Event|Placebo|
140912|NCT01605799|B3|Baseline|Total|Total of all reporting groups
140913|NCT01605799|B2|Baseline|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
140914|NCT01605799|B1|Baseline|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
140915|NCT01605799|P2|Participant Flow|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
140916|NCT01605799|P1|Participant Flow|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
140917|NCT01605799|O2|Outcome|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
140918|NCT01605799|O1|Outcome|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
140919|NCT01605799|O2|Outcome|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
140920|NCT01605799|O1|Outcome|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
141000|NCT01605370|B2|Baseline|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.
Metoprolol succinate: Metoprolol succinate 50 mg once daily"
140921|NCT01605799|E2|Reported Event|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
140922|NCT01605799|E1|Reported Event|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
140923|NCT01605669|B1|Baseline|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
140924|NCT01605669|P1|Participant Flow|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
140925|NCT01605669|O2|Outcome|Mean Pressure Gradient <30mmHg (Negative)|
140926|NCT01605669|O1|Outcome|Mean Pressure Gradient >=30mmHg (Positive)|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
140927|NCT01605669|E1|Reported Event|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
140928|NCT01605617|B3|Baseline|Total|Total of all reporting groups
141492|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
140929|NCT01605617|B2|Baseline|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate.
140930|NCT01605617|B1|Baseline|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo.
140931|NCT01605617|P2|Participant Flow|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo (12 weeks), washout (4 weeks), PTNS + 4mg of fesoterodine fumarate (12 weeks)
140932|NCT01605617|P1|Participant Flow|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks), Washout (4 weeks), PTNS + placebo (12 weeks)
140933|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
140934|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
140935|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
140936|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
140937|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
140938|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
140939|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
140940|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
140941|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
140942|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
140943|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
140944|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
140945|NCT01605617|E4|Reported Event|While on PTNS + Fesoterodine Fumarate Second|Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks)
140946|NCT01605617|E3|Reported Event|While on PTNS + Placebo Second|Participants were to be given PTNS + placebo (12 weeks)
140947|NCT01605617|E2|Reported Event|While on PTNS + Placebo First|Participants were given PTNS + placebo (12 weeks)
140948|NCT01605617|E1|Reported Event|While on PTNS + Fesoterodine Fumarate First|Participants were given PTNS + 4mg of fesoterodine fumarate (12 weeks)
140949|NCT01605552|B3|Baseline|Total|Total of all reporting groups
140972|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.
Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
140973|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.
Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
141001|NCT01605370|B1|Baseline|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.
Nebivolol: Nebivolol 2.5 mg once daily"
140950|NCT01605552|B2|Baseline|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.
Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
140951|NCT01605552|B1|Baseline|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)
Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
141493|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
140952|NCT01605552|P2|Participant Flow|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.
Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
140953|NCT01605552|P1|Participant Flow|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)
Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
140954|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.
Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
140955|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)
Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
140956|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.
Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
140957|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)
Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
140998|NCT01605461|E1|Reported Event|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
140958|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.
Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
140959|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)
Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
140960|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.
Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
140961|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)
Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
140962|NCT01605552|E2|Reported Event|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.
Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
140963|NCT01605552|E1|Reported Event|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)
Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
140964|NCT01605539|B3|Baseline|Total|Total of all reporting groups
140965|NCT01605539|B2|Baseline|CBD Group|"The two arms (400 mg and 800 mg of Cannabidiol) were combined for analysis because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.
Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
140966|NCT01605539|B1|Baseline|Control|"Subjects received pills that resemble the Cannabidiol capsule but did not have its properties.
Control: Subjects receivd a harmless, inactive pill to compare and validate the results of the other arms of the study"
140967|NCT01605539|P3|Participant Flow|CBD 800 Group|Subjects in Arm CBD 800 will receive 800 mg of Cannabidiol in each of the three test sessions
140968|NCT01605539|P2|Participant Flow|CBD 400 Group|"Subjects will receive 400 mg of cannabidiol
Subjects in Arm CBD 400 will receive 400 mg of Cannabidiol in each of the three test sessions"
140969|NCT01605539|P1|Participant Flow|Control|"Subjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties.
Control: Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study"
140970|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.
Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
140971|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.
Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
140999|NCT01605370|B3|Baseline|Total|Total of all reporting groups
140974|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.
Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
140975|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.
Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
140976|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.
Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
140977|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.
Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
140978|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.
Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
141494|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
140979|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.
Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
140980|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.
Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
140981|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.
Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
140982|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.
Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
140983|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.
Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
140984|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.
Subjects in Arm CBD will receive 400 mg or 800mg of Cannabidiol in each of the three test sessions"
140985|NCT01605539|O1|Outcome|Control|"Subjects received pills that resembled the Cannabidiol capsule but did not have have its properties.
Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
140986|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.
Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
140987|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.
Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
140988|NCT01605539|E2|Reported Event|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.
Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
140989|NCT01605539|E1|Reported Event|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.
Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
140990|NCT01605461|B1|Baseline|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
140991|NCT01605461|P1|Participant Flow|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
140992|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
140993|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
140994|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
140995|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
140996|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
140997|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
141002|NCT01605370|P2|Participant Flow|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.
Metoprolol succinate: Metoprolol succinate 50 mg once daily"
141003|NCT01605370|P1|Participant Flow|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.
Nebivolol: Nebivolol 2.5 mg once daily"
141004|NCT01605370|O2|Outcome|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.
Metoprolol succinate: Metoprolol succinate 50 mg once daily"
141005|NCT01605370|O1|Outcome|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.
Nebivolol: Nebivolol 2.5 mg once daily"
141006|NCT01605370|E2|Reported Event|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.
Metoprolol succinate: Metoprolol succinate 50 mg once daily"
141007|NCT01605370|E1|Reported Event|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.
Nebivolol: Nebivolol 2.5 mg once daily"
141008|NCT01605292|B3|Baseline|Total|Total of all reporting groups
141009|NCT01605292|B2|Baseline|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141010|NCT01605292|B1|Baseline|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141011|NCT01605292|P2|Participant Flow|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141012|NCT01605292|P1|Participant Flow|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141013|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141014|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141015|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141016|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141017|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141018|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141019|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141020|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141021|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141022|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141023|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141024|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141025|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141026|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141027|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141028|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141029|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141030|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141031|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141032|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141033|NCT01605292|E2|Reported Event|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
141034|NCT01605292|E1|Reported Event|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle."
141035|NCT01604941|B3|Baseline|Total|Total of all reporting groups
141036|NCT01604941|B2|Baseline|SPD602 75mg/kg/Day|Participants received SPD602 75mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141037|NCT01604941|B1|Baseline|SPD602 50mg/kg/Day|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141038|NCT01604941|P6|Participant Flow|SPD602 75mg/kg/Day Once Daily Dosing (QD)|Participants were randomly assigned to 75 mg/kg/day oral QD dosing and continued QD dosing until the end of study (24 weeks) or early discontinuation.
141039|NCT01604941|P5|Participant Flow|SPD602 50mg/kg/Day Once Daily Dosing (QD)|Participants were randomly assigned to 50 mg/kg/day oral QD dosing and continued QD dosing until the end of study (24 weeks) or early discontinuation.
141040|NCT01604941|P4|Participant Flow|SPD602 75mg/kg/Day Once (QD) Then Twice Daily Dosing (BID)|Participants were randomly assigned to QD dosing then re-enrolled to 75 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
141041|NCT01604941|P3|Participant Flow|SPD602 50mg/kg/Day Once (QD) Then Twice Daily Dosing (BID)|Participants were randomly assigned to QD dosing then re-enrolled to 50 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
141042|NCT01604941|P2|Participant Flow|SPD602 75mg/kg/Day Twice Daily Dosing (BID)|Participants were randomly assigned to 75 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
141043|NCT01604941|P1|Participant Flow|SPD602 50mg/mg/Day Twice Daily Dosing (BID)|Participants were randomly assigned to 50 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
141044|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
141045|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141046|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
141047|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141048|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
141049|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141050|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
141051|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141052|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
141053|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141054|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
141055|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141056|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
141057|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141058|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
141059|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141060|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
141061|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141062|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
141063|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141127|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141064|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
141065|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
141066|NCT01604941|E2|Reported Event|SPD602 75mg/kg/Day|Participants received SPD602 75mg/kg/day oral dosing BID either as originally randomized or as a re-enrolled participant.
141067|NCT01604941|E1|Reported Event|SPD602 50mg/kg/Day|Participants received SPD602 50mg/kg/day oral dosing BID either as originally randomized or as a re-enrolled participant.
141068|NCT01604850|B3|Baseline|Total|Total of all reporting groups
141069|NCT01604850|B2|Baseline|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
141070|NCT01604850|B1|Baseline|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
141495|NCT01603043|E2|Reported Event|Sham Injection|1 mock injection per month for 12 months
141071|NCT01604850|P2|Participant Flow|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
141072|NCT01604850|P1|Participant Flow|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
141073|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
141074|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
141075|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
141076|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
141077|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
141078|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
141079|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
141080|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
141081|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
141082|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
141083|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
141084|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
141085|NCT01604850|E2|Reported Event|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
141086|NCT01604850|E1|Reported Event|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.
Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
141087|NCT01604772|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: 150 mg given PO"
141088|NCT01604772|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: 150 mg given PO"
141089|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: 150 mg given PO"
141214|NCT01603940|B3|Baseline|Total|Total of all reporting groups
145202|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
141090|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: 150 mg given PO"
141091|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|
141092|NCT01604772|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: 150 mg given PO"
141093|NCT01604278|B3|Baseline|Total|Total of all reporting groups
141094|NCT01604278|B2|Baseline|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141095|NCT01604278|B1|Baseline|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141096|NCT01604278|P2|Participant Flow|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141097|NCT01604278|P1|Participant Flow|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141098|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141099|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141100|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141101|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141102|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141103|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141104|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141105|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141106|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141107|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141108|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141109|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141110|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141111|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141112|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141113|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141114|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141115|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141116|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141117|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141118|NCT01604278|E2|Reported Event|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
141119|NCT01604278|E1|Reported Event|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
141120|NCT01604265|B3|Baseline|Total|Total of all reporting groups
141121|NCT01604265|B2|Baseline|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141122|NCT01604265|B1|Baseline|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141123|NCT01604265|P2|Participant Flow|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141124|NCT01604265|P1|Participant Flow|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141125|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141126|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141478|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141128|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141129|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141130|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141131|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141132|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141133|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141134|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141898|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
141135|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141136|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141137|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141138|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141139|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141140|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141141|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141142|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141143|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141144|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141145|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141146|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141147|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141148|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141149|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141150|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141151|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141152|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141153|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141154|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141155|NCT01604265|E2|Reported Event|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
141156|NCT01604265|E1|Reported Event|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
141157|NCT01604122|B3|Baseline|Total|Total of all reporting groups
141158|NCT01604122|B2|Baseline|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141159|NCT01604122|B1|Baseline|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141160|NCT01604122|P2|Participant Flow|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141161|NCT01604122|P1|Participant Flow|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141273|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141162|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141163|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141164|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141165|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141166|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141167|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141168|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141169|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141170|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141171|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141172|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141173|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141174|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141175|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141176|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141177|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141178|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141179|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141180|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141181|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141182|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141183|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141184|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141185|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141186|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141513|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
141187|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141188|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141189|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141190|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141220|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
141191|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141192|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141193|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141194|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141195|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141196|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141197|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141198|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141199|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141200|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141201|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141202|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141203|NCT01604122|E2|Reported Event|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
141204|NCT01604122|E1|Reported Event|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
141205|NCT01604109|B3|Baseline|Total|Total of all reporting groups
141206|NCT01604109|B2|Baseline|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate
the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
141207|NCT01604109|B1|Baseline|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste
10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
141208|NCT01604109|P2|Participant Flow|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate
the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
141209|NCT01604109|P1|Participant Flow|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste
10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
141210|NCT01604109|O2|Outcome|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate
the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
141211|NCT01604109|O1|Outcome|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste
10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
141212|NCT01604109|E2|Reported Event|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate
the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
141213|NCT01604109|E1|Reported Event|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste
10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
141215|NCT01603940|B2|Baseline|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
141216|NCT01603940|B1|Baseline|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
141217|NCT01603940|P2|Participant Flow|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
141218|NCT01603940|P1|Participant Flow|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
141219|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
141221|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
141222|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
141223|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
141224|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
141225|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
141226|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
141227|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
141228|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
141229|NCT01603940|E2|Reported Event|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.
Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
141230|NCT01603940|E1|Reported Event|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.
Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
141231|NCT01603875|B4|Baseline|Total|Total of all reporting groups
141232|NCT01603875|B3|Baseline|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141233|NCT01603875|B2|Baseline|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141234|NCT01603875|B1|Baseline|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141235|NCT01603875|P3|Participant Flow|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141236|NCT01603875|P2|Participant Flow|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141237|NCT01603875|P1|Participant Flow|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141238|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141239|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141240|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141241|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141242|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141243|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141244|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141514|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
141245|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141246|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141247|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141248|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141249|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141496|NCT01603043|E1|Reported Event|AL-78898A|1 intravitreal injection per month for up to 12 months
141250|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141251|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141252|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141253|NCT01603875|E3|Reported Event|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141254|NCT01603875|E2|Reported Event|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141255|NCT01603875|E1|Reported Event|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
141256|NCT01603459|B1|Baseline|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.
For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
141257|NCT01603459|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.
For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
141258|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141259|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141260|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141261|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141262|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141263|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141264|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141265|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141266|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141267|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141268|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141269|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141270|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141271|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141272|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141274|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141275|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141276|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141277|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141278|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141279|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141497|NCT01602965|B3|Baseline|Total|Total of all reporting groups
141280|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141281|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141282|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141283|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141284|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141285|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141286|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141287|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141288|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141289|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141290|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141291|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141292|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141293|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141294|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141295|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141296|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141297|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141298|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141299|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141300|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141301|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141302|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141303|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141304|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141305|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141306|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141307|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141308|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141309|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141310|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141311|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141312|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141313|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141314|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141315|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141481|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141316|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141317|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141318|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141319|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141320|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141321|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141322|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141323|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141324|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141325|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141326|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141327|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141328|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141329|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141330|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141331|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141332|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141333|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141334|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141335|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141336|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141337|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141338|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141339|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141340|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141341|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141342|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141343|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141344|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141345|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141346|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141347|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141348|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141349|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141899|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
141350|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141351|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141352|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141353|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141354|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141355|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141356|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141357|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141358|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141359|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141360|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141361|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141362|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Timeframe 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141363|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141364|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141365|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141366|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141367|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141368|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141369|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141370|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
141371|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141372|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
141373|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141374|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
141375|NCT01603459|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.
For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
141376|NCT01603420|B3|Baseline|Total|Total of all reporting groups
141377|NCT01603420|B2|Baseline|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141477|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141378|NCT01603420|B1|Baseline|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141379|NCT01603420|P2|Participant Flow|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141482|NCT01603056|E2|Reported Event|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141380|NCT01603420|P1|Participant Flow|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141381|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141382|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141383|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141384|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141385|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141386|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141387|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141388|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141389|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141390|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141391|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141392|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141393|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141394|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141412|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141395|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141483|NCT01603056|E1|Reported Event|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141484|NCT01603043|B3|Baseline|Total|Total of all reporting groups
141396|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141397|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141398|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141399|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141400|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141401|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141402|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141403|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141404|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141405|NCT01603420|E2|Reported Event|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141406|NCT01603420|E1|Reported Event|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.
Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
141407|NCT01603394|B1|Baseline|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141408|NCT01603394|P1|Participant Flow|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141409|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141410|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141411|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141475|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141413|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141414|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141415|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141416|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141417|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141418|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141419|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141420|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141421|NCT01603394|E1|Reported Event|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
141422|NCT01603277|B3|Baseline|Total|Total of all reporting groups
141423|NCT01603277|B2|Baseline|Normal Saline|Placebo: Normal Saline
141424|NCT01603277|B1|Baseline|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
141425|NCT01603277|P2|Participant Flow|Normal Saline|Placebo: Normal Saline
141426|NCT01603277|P1|Participant Flow|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
141427|NCT01603277|O2|Outcome|Normal Saline|Placebo: Normal Saline
141428|NCT01603277|O1|Outcome|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
141429|NCT01603277|E2|Reported Event|Normal Saline|Placebo: Normal Saline
141430|NCT01603277|E1|Reported Event|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
141431|NCT01603121|B1|Baseline|All Study Participants|Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart.
141432|NCT01603121|P2|Participant Flow|Lisofylline Intravenous First, Then Lisofylline Subcutaneous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period
Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
141433|NCT01603121|P1|Participant Flow|Lisofylline Subcutaneous First, Then Lisofylline Intravenous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period
Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
141434|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period
Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
141435|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period
Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
141436|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period
Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
141437|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period
Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
141438|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period
Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
141439|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period
Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
141440|NCT01603121|E2|Reported Event|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period
Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
141441|NCT01603121|E1|Reported Event|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period
Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
141442|NCT01603082|B3|Baseline|Total|Total of all reporting groups
141443|NCT01603082|B2|Baseline|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
141444|NCT01603082|B1|Baseline|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
141445|NCT01603082|P2|Participant Flow|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
141446|NCT01603082|P1|Participant Flow|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
141447|NCT01603082|O2|Outcome|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
141448|NCT01603082|O1|Outcome|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
141449|NCT01603082|O2|Outcome|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
141450|NCT01603082|O1|Outcome|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
141451|NCT01603082|E2|Reported Event|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
141452|NCT01603082|E1|Reported Event|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
141453|NCT01603056|B3|Baseline|Total|Total of all reporting groups
141454|NCT01603056|B2|Baseline|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141455|NCT01603056|B1|Baseline|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141456|NCT01603056|P2|Participant Flow|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141457|NCT01603056|P1|Participant Flow|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141458|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141459|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141460|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141461|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141462|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141463|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141464|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141465|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141466|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141467|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141468|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141469|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141470|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141471|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141472|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141473|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141474|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141476|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141479|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141480|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
141498|NCT01602965|B2|Baseline|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.
Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
141499|NCT01602965|B1|Baseline|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.
Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
141500|NCT01602965|P2|Participant Flow|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.
Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
141501|NCT01602965|P1|Participant Flow|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.
Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
141502|NCT01602965|O2|Outcome|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.
Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
141503|NCT01602965|O1|Outcome|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.
Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
141504|NCT01602965|E2|Reported Event|Self Help Informative Booklet|"Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.
Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies"
141505|NCT01602965|E1|Reported Event|Counseling Monthly Phone Calls|"the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.
Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels."
141506|NCT01602744|B3|Baseline|Total|Total of all reporting groups
141507|NCT01602744|B2|Baseline|Intervention STOPP/START|Screening medications with STOPP/START critera
141508|NCT01602744|B1|Baseline|Controll|The medications in this arm will not be screened.
141509|NCT01602744|P2|Participant Flow|Intervention STOPP/START|Screening medications with STOPP/START critera
141510|NCT01602744|P1|Participant Flow|Controll|The medications in this arm will not be screened.
141511|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
141512|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
141515|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
141516|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
141517|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
141518|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
141519|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
141520|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
141521|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
141522|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
141523|NCT01602744|E2|Reported Event|Intervention STOPP/START|Screening medications with STOPP/START critera
141524|NCT01602744|E1|Reported Event|Controll|The medications in this arm will not be screened.
141525|NCT01602731|B1|Baseline|AMDD|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study
Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
141526|NCT01602731|P1|Participant Flow|Automated Medication Dispensing Device|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study
Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
141527|NCT01602731|O1|Outcome|Automated Medication Dispensing Device|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study
Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
141528|NCT01602731|O2|Outcome|After AMDD|Adherence was measured with the use of the AMDD as a 30-day pill count
141529|NCT01602731|O1|Outcome|Before AMDD|Adherence was measured by 30-day pill count before the use of AMDD
141530|NCT01602731|E1|Reported Event|AMDD|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study
Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
141531|NCT01602562|B3|Baseline|Total|Total of all reporting groups
141532|NCT01602562|B2|Baseline|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141533|NCT01602562|B1|Baseline|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141534|NCT01602562|P2|Participant Flow|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kilogram (kg) body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141535|NCT01602562|P1|Participant Flow|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a valaciclovir hydrochloride (VACV) tablet containing 500 milligrams (mg) of valaciclovir orally twice daily for 43 days, from 7 days before hematopoietic stem cell transplantation (HSCT) to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141536|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141537|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141538|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141539|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141540|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141578|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
145203|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
141541|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141542|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141543|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141544|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141545|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141546|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141547|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141548|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141549|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141550|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141551|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141552|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141553|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141554|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141555|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141579|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141580|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141556|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and & <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141557|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141558|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141559|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141592|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141593|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141560|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141561|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141562|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141563|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141564|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141565|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141566|NCT01602562|E2|Reported Event|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141567|NCT01602562|E1|Reported Event|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
141568|NCT01602549|B3|Baseline|Total|Total of all reporting groups
141569|NCT01602549|B2|Baseline|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141570|NCT01602549|B1|Baseline|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141571|NCT01602549|P2|Participant Flow|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141572|NCT01602549|P1|Participant Flow|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141573|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141574|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141575|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141576|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141577|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
145204|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
141581|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141582|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141583|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141584|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141585|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141586|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141587|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141588|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141589|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141590|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141591|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141594|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141595|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141596|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141597|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141598|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141599|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141600|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141601|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141602|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141603|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141604|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141605|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141606|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141607|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141608|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141609|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141610|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141611|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141612|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141613|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141614|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141615|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141616|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141617|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141618|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141619|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141620|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
141621|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141622|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141623|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141624|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141625|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141626|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141627|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141628|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141629|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141630|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141631|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141632|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141633|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141634|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141635|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141636|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141637|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141638|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141639|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141900|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
141640|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141641|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141642|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141643|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141644|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141645|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141646|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141647|NCT01602549|E3|Reported Event|GSK962040 125 mg|Participants received GSK962040 125 milligrams (mg) administered orally once daily for 7 to 9 days.
141648|NCT01602549|E2|Reported Event|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
141649|NCT01602549|E1|Reported Event|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
141650|NCT01602510|B1|Baseline|Open Label Lamotrigine 200 mg/Day|Participants (Par.) received lamotrigine escalated to a target dose of lamotrigine 200 mg/day monotherapy for 6 weeks to 16 weeks. If needed, concomitant psychotropic medications were permitted during this phase however medications were discontinued at least 1 week before entering into the double-blind phase.
141651|NCT01602510|P3|Participant Flow|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141652|NCT01602510|P2|Participant Flow|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141653|NCT01602510|P1|Participant Flow|Open Label Lamotrigine 200 mg/Day|Participants (Par.) received lamotrigine escalated to a target dose of lamotrigine 200mg/day monotherapy for 6 weeks to 16 weeks. If needed, concomitant psychotropic medications were permitted during this phase however medications were discontinued at least 1 week before entering into the double-blind phase.
141654|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141655|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141656|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141657|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141658|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141659|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141660|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141661|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141662|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141663|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141693|NCT01602471|O1|Outcome|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
141664|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141665|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141666|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141667|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141668|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141669|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141670|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141671|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141672|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141673|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141674|NCT01602510|E2|Reported Event|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
141675|NCT01602510|E1|Reported Event|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
141676|NCT01602484|B3|Baseline|Total|Total of all reporting groups
141677|NCT01602484|B2|Baseline|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
141678|NCT01602484|B1|Baseline|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
141679|NCT01602484|P2|Participant Flow|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
141680|NCT01602484|P1|Participant Flow|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
141681|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
141682|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
141683|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
141684|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
141685|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
141686|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
141687|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
141688|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
141689|NCT01602484|E2|Reported Event|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
141690|NCT01602484|E1|Reported Event|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
141691|NCT01602471|B1|Baseline|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
141692|NCT01602471|P1|Participant Flow|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
141694|NCT01602471|E1|Reported Event|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
141695|NCT01602380|B3|Baseline|Total|Total of all reporting groups
141696|NCT01602380|B2|Baseline|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
141697|NCT01602380|B1|Baseline|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141698|NCT01602380|P2|Participant Flow|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
141699|NCT01602380|P1|Participant Flow|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141700|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
141701|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141702|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
141703|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141704|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
141705|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141706|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
142221|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
141707|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141708|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
141709|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141710|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
141730|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141901|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
141711|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141712|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
141713|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141714|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
141715|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141716|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
141717|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141718|NCT01602380|E2|Reported Event|Anastrozole 1 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
141719|NCT01602380|E1|Reported Event|Fulvestrant 500 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
141720|NCT01602341|B3|Baseline|Total|Total of all reporting groups
141721|NCT01602341|B2|Baseline|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141722|NCT01602341|B1|Baseline|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141723|NCT01602341|P2|Participant Flow|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141724|NCT01602341|P1|Participant Flow|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate atopic dermatitis (AD), once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
142222|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
141725|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141726|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141727|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141728|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141729|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141731|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141732|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141733|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141734|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141735|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141736|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141737|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141738|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141739|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141740|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141741|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141742|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141743|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141744|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141745|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
142223|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
141746|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141747|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141748|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141749|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141750|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141751|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141902|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
141752|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141753|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141754|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141755|NCT01602341|E2|Reported Event|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141756|NCT01602341|E1|Reported Event|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
141757|NCT01602198|B3|Baseline|Total|Total of all reporting groups
141758|NCT01602198|B2|Baseline|Placebo Transdermal Patch|"Placebo transdermal patch
Placebo patch: Placebo patch 1/day for 6 months"
141759|NCT01602198|B1|Baseline|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch
Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
141760|NCT01602198|P2|Participant Flow|Placebo Transdermal Patch|"Placebo transdermal patch
Placebo patch: Placebo patch 1/day for 6 months"
141761|NCT01602198|P1|Participant Flow|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch
Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
141762|NCT01602198|O2|Outcome|Placebo Transdermal Patch|"Placebo transdermal patch
Placebo patch: Placebo patch 1/day for 6 months"
141763|NCT01602198|O1|Outcome|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch
Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
141764|NCT01602198|E2|Reported Event|Placebo Transdermal Patch|"Placebo transdermal patch
Placebo patch: Placebo patch 1/day for 6 months"
141765|NCT01602198|E1|Reported Event|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch
Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
141766|NCT01602016|B1|Baseline|All Participants|
141767|NCT01602016|P1|Participant Flow|All Participants|
141768|NCT01602016|O1|Outcome|All Participants|
141769|NCT01602016|E1|Reported Event|All Participants|
141770|NCT01601977|B1|Baseline|All Participants|Single arm crossover nonrandomised study
141771|NCT01601977|P1|Participant Flow|All Study Participants|Initial study period in usual care then switched to novel ventilation with AVAPS-AE algorithm
141772|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation
Usual care: usual care
crossover trial, as per intervention"
141773|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study
Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
141774|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation
Usual care: usual care
crossover trial, as per intervention"
141775|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study
Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
141776|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation
Usual care: usual care
crossover trial, as per intervention"
141777|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study
Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
141778|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation
Usual care: usual care
crossover trial, as per intervention"
141779|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study
Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
141780|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation
Usual care: usual care
crossover trial, as per intervention"
141781|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study
Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
141782|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation
Usual care: usual care
crossover trial, as per intervention"
141783|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study
Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
141784|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation
Usual care: usual care
crossover trial, as per intervention"
141785|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study
Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
141786|NCT01601977|E2|Reported Event|Usual Care|"Usual care including non-invasive ventilation
Usual care: usual care"
141787|NCT01601977|E1|Reported Event|Intervention|"Single arm, open labelled study
Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
141788|NCT01601821|B3|Baseline|Total|Total of all reporting groups
141789|NCT01601821|B2|Baseline|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141831|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141903|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
141904|NCT01601236|E4|Reported Event|Overall|Groups 1, 2, 3, 4, 5, 6
141790|NCT01601821|B1|Baseline|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141791|NCT01601821|P2|Participant Flow|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141792|NCT01601821|P1|Participant Flow|CsA+Rapamune+CS|Month 0-3: rapamune 6 milligram (mg) tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 nanogram per milliliter (ng/mL) in combination with cyclosporine (CsA) tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, mycophenolate mofetil (MMF) tablet orally at a dose of 1-1.5 grams per day (g/day) and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received corticosteroids (CS) tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141793|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141794|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141795|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141796|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141797|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141798|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141799|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141828|NCT01601704|P2|Participant Flow|Placebo|"Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
142224|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142225|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
141800|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141801|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141882|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
141883|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
141884|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
141885|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
141802|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141803|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141804|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141805|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141806|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141807|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141808|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141809|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141810|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141811|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141812|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141813|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141814|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141815|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141816|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141817|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141818|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141819|NCT01601821|E2|Reported Event|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141820|NCT01601821|E1|Reported Event|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
141821|NCT01601782|B1|Baseline|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.
Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.
Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
141822|NCT01601782|P1|Participant Flow|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.
Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.
Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
141823|NCT01601782|O1|Outcome|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.
Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.
Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
141824|NCT01601782|E1|Reported Event|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.
Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.
Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
141825|NCT01601704|B3|Baseline|Total|Total of all reporting groups
141826|NCT01601704|B2|Baseline|Placebo|"Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141827|NCT01601704|B1|Baseline|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141829|NCT01601704|P1|Participant Flow|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141830|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141886|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
141887|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
141888|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
141832|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141833|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141834|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141835|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141836|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141837|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141838|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141839|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141840|NCT01601704|E2|Reported Event|Placebo|"Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141841|NCT01601704|E1|Reported Event|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
141842|NCT01601691|B1|Baseline|Spacer|"Subjects with spacer injection
DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
141843|NCT01601691|P1|Participant Flow|Spacer|"Subjects with spacer injection
DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
141844|NCT01601691|O1|Outcome|Spacer|"Subjects with spacer injection
DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
141845|NCT01601691|E1|Reported Event|Spacer|"Subjects with spacer injection
DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
141846|NCT01601470|B1|Baseline|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141870|NCT01601236|P4|Participant Flow|Group 4: Placebo (0.2 mL) Daily|Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the API administered via daily SC injection for 36 weeks
142226|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
141847|NCT01601470|P1|Participant Flow|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141848|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141849|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141889|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
141890|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
141850|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141851|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141852|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141853|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141854|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141855|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141856|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141857|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
141858|NCT01601470|E3|Reported Event|Period 3: LCZ696 + Sildenafil|In Period 3, on study Day 8, participants received LCZ696 , co-administered at the same time with a single dose of sildenafil.
141859|NCT01601470|E2|Reported Event|Period 2: LCZ696|In Period 2 (study Days 3-7), participants received LCZ696 once daily.
141860|NCT01601470|E1|Reported Event|Period 1: Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by wash out on Day 2.
141861|NCT01601236|B7|Baseline|Total|Total of all reporting groups
141862|NCT01601236|B6|Baseline|Group 6: Placebo (0.4 mL) Daily|"Placebo
Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes."
141863|NCT01601236|B5|Baseline|Group 5: Acthar 32 U (0.4 mL) Daily|"Repository Corticotropin Injection
Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)]."
141864|NCT01601236|B4|Baseline|Group 4: Placebo (0.2 mL) Daily|"Placebo
Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes."
141865|NCT01601236|B3|Baseline|Group 3: Acthar 16 U (0.2 mL) Daily|"Repository Corticotropin Injection
Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)]."
141866|NCT01601236|B2|Baseline|Group 2: Placebo (0.1 mL) Daily|"Placebo
Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes."
141867|NCT01601236|B1|Baseline|Group 1: Acthar 8 U (0.1 mL) Daily|"Repository Corticotropin Injection
Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)]."
141868|NCT01601236|P6|Participant Flow|Group 6: Placebo (0.4 mL) Daily|Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the API administered via daily SC injection for 36 weeks
141869|NCT01601236|P5|Participant Flow|Group 5: Acthar 32 U (0.4 mL) Daily|H.P. Acthar Gel (repository corticotropin injection) administered via daily SC injection for 36 weeks
141871|NCT01601236|P3|Participant Flow|Group 3: Acthar 16 U (0.2 mL) Daily|H.P. Acthar Gel (repository corticotropin injection) administered via daily SC injection for 36 weeks
141872|NCT01601236|P2|Participant Flow|Group 2: Placebo (0.1 mL) Daily|Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API)administered via daily SC injection for 36 weeks
141873|NCT01601236|P1|Participant Flow|Group 1: Acthar 8 U (0.1 mL) Daily|H.P. Acthar Gel (repository corticotropin injection) administered via daily subcutaneous (SC) injection for 36 weeks
141874|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
141875|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
141876|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
141877|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
141878|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
141879|NCT01601236|O1|Outcome|Placebo|Groups 2, 4, 6
141880|NCT01601236|O3|Outcome|Acthar 16 Units|Groups 3, 5
141881|NCT01601236|O2|Outcome|Acthar 8 Units|Group 1
141905|NCT01601236|E3|Reported Event|Acthar 16 Units|Groups 3, 5; This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3). Thus, Adverse Events were not collected separately for these Arms.
141906|NCT01601236|E2|Reported Event|Acthar 8 Units|Group 1
141907|NCT01601236|E1|Reported Event|Placebo|Groups 2, 4, 6
141908|NCT01601132|B1|Baseline|Theophylline + Colchicine|Theophylline 300 mg, solution, orally, on Day 1, then colchicine 0.6 mg tablets, orally, twice daily on Days 5–18, then theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
141909|NCT01601132|P1|Participant Flow|Theophylline + Colchicine|Theophylline 300 mg, solution, orally, on Day 1, then colchicine 0.6 mg tablets, orally, twice daily on Days 5–18, then theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
141910|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
141911|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
141912|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
141913|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
141914|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
141915|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
141916|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
141917|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
141918|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
141919|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
141920|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
141921|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
141922|NCT01601132|E3|Reported Event|Colchicine + Theophylline|Theophylline 300 mg, solution, orally, single dose and colchicine 0.6 mg, tablets, orally, twice daily, on Day 19.
141923|NCT01601132|E2|Reported Event|Colchicine|Colchicine, 0.6 mg tablet, orally, twice daily, from Days 5-18.
141924|NCT01601132|E1|Reported Event|Theophylline|Theophylline 300 mg, solution, orally, on Day 1, followed by a 4-day washout period.
141925|NCT01600950|B1|Baseline|All Participants|A single 0.3 units/kilogram (U/kg) dose of either LY2963016 or LANTUS was administered subcutaneously on Day 1 of Periods 1 or 2.
141926|NCT01600950|P2|Participant Flow|Lantus/LY2963016|"A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.
A single 0.3 U/kg dose of LY2963016 was administered subcutaneously on Day 1 during Period 2."
141927|NCT01600950|P1|Participant Flow|LY2963016/Lantus|"A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.
A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 2."
141928|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
141929|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
141930|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
141931|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
141932|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
141933|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
141934|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
141935|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
141936|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
141937|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
141938|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
141939|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
141940|NCT01600950|E2|Reported Event|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
141941|NCT01600950|E1|Reported Event|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
141942|NCT01600885|B1|Baseline|Overall Study|This 'arm' consists of all study participants who started the first Study Period. This Study Period consisted of an initial screening visit in which it was determined whether participants met the inclusion/exclusion criteria for further participation in this study.
141961|NCT01600716|P2|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
141943|NCT01600885|P2|Participant Flow|Placebo Then Guanfacine|"During the first study session, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI.
Placebo then Guanfacine: During the first study session, the patient will be given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.
The second study session will be identical except that the patient will be given 3mg of guanfacine instead of the placebo."
141944|NCT01600885|P1|Participant Flow|Guanfacine Then Placebo|"During the first study session, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive a placebo before undergoing a ketamine-infusion fMRI.
Guanfacine then Placebo: During the first study session, the patient will be given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.
The second study session will be identical except that the patient will be given a placebo instead of the guanfacine."
141945|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
141946|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
141947|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
141948|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
141949|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
141985|NCT01600703|E1|Reported Event|Placebo|placebo, oral, single dose
141950|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
141951|NCT01600885|E2|Reported Event|Placebo|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
141952|NCT01600885|E1|Reported Event|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
141953|NCT01600729|B1|Baseline|All Participants|Participants with facial lines. There was no intervention in this study.
141954|NCT01600729|P1|Participant Flow|All Participants|Participants with facial lines. There was no intervention in this study.
141955|NCT01600729|O1|Outcome|All Participants|Participants with facial lines. There was no intervention in this study.
141956|NCT01600729|O1|Outcome|All Participants|Participants with facial lines. There was no intervention in this study.
141957|NCT01600729|E1|Reported Event|All Participants|Participants with facial lines. There was no intervention in this study.
141958|NCT01600716|B3|Baseline|Total|Total of all reporting groups
141959|NCT01600716|B2|Baseline|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
141960|NCT01600716|B1|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
142166|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
141962|NCT01600716|P1|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
141963|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
141964|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
141965|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
141966|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
141967|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
141968|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
141969|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
141970|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
141971|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
141972|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
141973|NCT01600716|E4|Reported Event|Placebo (Normal Saline)/OnabotulinumtoxinA|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, an onabotulinumtoxinA injection is given. Median duration of exposure is 12.2 weeks.
141974|NCT01600716|E3|Reported Event|OnabotulinumtoxinA/OnabotulinumtoxinA Treatment Cycle 2|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, a second onabotulinumtoxinA injection is given. Median duration of exposure is 12.5 weeks.
141975|NCT01600716|E2|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. Median duration of exposure is 15.2 weeks.
141976|NCT01600716|E1|Reported Event|OnabotulinumtoxinA Treatment Cycle 1|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. Median duration of exposure is 50.7 weeks.
141977|NCT01600703|B1|Baseline|All Study Participants|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
141978|NCT01600703|P2|Participant Flow|Sitagliptin First, Then Placebo|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
141979|NCT01600703|P1|Participant Flow|Placebo First, Then Sitagliptin|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
141980|NCT01600703|O2|Outcome|Sitagliptin|sitagliptin, 100 mg, oral, single dose
141981|NCT01600703|O1|Outcome|Placebo|placebo, oral, single dose
141982|NCT01600703|O2|Outcome|Sitagliptin|sitagliptin, 100 mg, oral, single dose
141983|NCT01600703|O1|Outcome|Placebo|placebo, oral, single dose
141984|NCT01600703|E2|Reported Event|Sitagliptin|sitagliptin, 100mg, oral, single dose
141987|NCT01600677|B2|Baseline|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.
Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
141988|NCT01600677|B1|Baseline|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.
Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
141989|NCT01600677|P2|Participant Flow|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.
Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
141990|NCT01600677|P1|Participant Flow|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.
Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
142144|NCT01600014|O2|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|See primary endpoint for previously defined description
141991|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.
Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
141992|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.
Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
141993|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.
Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
141994|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.
Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
141995|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.
Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
141996|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.
Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
142030|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
141997|NCT01600677|E2|Reported Event|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.
Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
141998|NCT01600677|E1|Reported Event|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.
Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
141999|NCT01600495|B3|Baseline|Total|Total of all reporting groups
142000|NCT01600495|B2|Baseline|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
142001|NCT01600495|B1|Baseline|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
142002|NCT01600495|P2|Participant Flow|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
142003|NCT01600495|P1|Participant Flow|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
142004|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
142005|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
142145|NCT01600014|O1|Outcome|Open Label Only (1st Cycle)|Subjects only treated during 1st cycle (450 participants excluding 203 participants also included in the 2nd cycle)
142006|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
142007|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
142008|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
142009|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
142010|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
142011|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
142012|NCT01600495|E2|Reported Event|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
142013|NCT01600495|E1|Reported Event|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
142014|NCT01600482|B3|Baseline|Total|Total of all reporting groups
142015|NCT01600482|B2|Baseline|Manual Compression|Manual Compression
142016|NCT01600482|B1|Baseline|CELT ACD Device|"The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
142017|NCT01600482|P2|Participant Flow|Manual Compression|Manual Compression
142018|NCT01600482|P1|Participant Flow|CELT ACD Device|"The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
142019|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
142020|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
142021|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
142022|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
142023|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
142024|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
142025|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
142026|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
142027|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
142028|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
142029|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
142031|NCT01600482|O2|Outcome|Manual Compression|Manual Compression
142032|NCT01600482|O1|Outcome|CELT ACD Device|"The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
142033|NCT01600482|E2|Reported Event|Manual Compression|Manual Compression
142034|NCT01600482|E1|Reported Event|CELT ACD Device|"The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath."
142035|NCT01600326|B3|Baseline|Total|Total of all reporting groups
142036|NCT01600326|B2|Baseline|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.
Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.
The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.
Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.
Subjects will see their referring physician two weeks after treatment to begin physical therapy."
142037|NCT01600326|B1|Baseline|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
142050|NCT01600287|P1|Participant Flow|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142164|NCT01599806|P2|Participant Flow|Doripenem|Doripenem treatment group
142165|NCT01599806|P1|Participant Flow|CAZ-AVI|Ceftazidime-avibactam treatment group
142038|NCT01600326|P2|Participant Flow|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.
Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.
The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.
Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.
Subjects will see their referring physician two weeks after treatment to begin physical therapy."
142039|NCT01600326|P1|Participant Flow|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
142040|NCT01600326|O2|Outcome|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.
Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.
The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.
Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.
Subjects will see their referring physician two weeks after treatment to begin physical therapy."
142041|NCT01600326|O1|Outcome|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
142042|NCT01600326|O2|Outcome|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.
Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.
The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.
Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.
Subjects will see their referring physician two weeks after treatment to begin physical therapy."
142043|NCT01600326|O1|Outcome|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
142072|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142073|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142074|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142227|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142044|NCT01600326|E2|Reported Event|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.
Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.
The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.
Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.
Subjects will see their referring physician two weeks after treatment to begin physical therapy."
142045|NCT01600326|E1|Reported Event|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
142046|NCT01600287|B3|Baseline|Total|Total of all reporting groups
142047|NCT01600287|B2|Baseline|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142048|NCT01600287|B1|Baseline|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142049|NCT01600287|P2|Participant Flow|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142051|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142052|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142053|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142054|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142055|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142056|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142057|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142058|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142059|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142060|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142061|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142062|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142063|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142064|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142065|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142066|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142067|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142068|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142069|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142070|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142071|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142075|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142076|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142077|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142078|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142079|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142080|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142081|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142082|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142083|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142084|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142085|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142086|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142087|NCT01600287|E2|Reported Event|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
142088|NCT01600287|E1|Reported Event|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
142089|NCT01600222|B1|Baseline|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142090|NCT01600222|P1|Participant Flow|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Once daily for up to 4 weeks
142091|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Once daily for up to 4 weeks
142092|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142093|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142094|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142095|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142096|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142097|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142098|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142099|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142100|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142101|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142102|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142103|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142104|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142105|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142106|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142107|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142108|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142109|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142110|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142111|NCT01600222|E1|Reported Event|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
142112|NCT01600092|B3|Baseline|Total|Total of all reporting groups
142113|NCT01600092|B2|Baseline|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142114|NCT01600092|B1|Baseline|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142115|NCT01600092|P2|Participant Flow|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142116|NCT01600092|P1|Participant Flow|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142117|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142118|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142119|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142120|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142121|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142143|NCT01600014|O3|Outcome|Vehicle Gel Field Recalcitrant Subgroup|See primary endpoint for previously defined description
142264|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142122|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142123|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142124|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142125|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142126|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142127|NCT01600092|E2|Reported Event|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142128|NCT01600092|E1|Reported Event|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
142129|NCT01600053|B1|Baseline|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles
Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
142130|NCT01600053|P1|Participant Flow|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles
Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
142131|NCT01600053|O1|Outcome|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles
Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
142132|NCT01600053|O1|Outcome|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles
Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
142133|NCT01600053|E1|Reported Event|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles
Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
142213|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142214|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142215|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142134|NCT01600014|B1|Baseline|Ingenol Mebutate 0.015% Gel (1.& 2. Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or controlled repeat use (2nd cycle) treatment of recalcitrant or recurrent AK lesions
142135|NCT01600014|P2|Participant Flow|Vehicle Gel (2nd Cycle)|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or repeat use (2nd cycle) once daily for 3 consecutive days with vehicle gel of the same treatment area, in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup) with follow-up until Week 52
142136|NCT01600014|P1|Participant Flow|Ingenol Mebutate Gel, 0.015% (1st & 2nd Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or repeat use (2nd cycle) once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area, in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup) with follow-up until Week 52
142137|NCT01600014|O4|Outcome|Vehicle Gel Field Recurrent Subgroup|See primary endpoint for previously defined description
142138|NCT01600014|O3|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|See primary endpoint for previously defined description
142139|NCT01600014|O2|Outcome|Vehicle Gel Field Recalcitrant Subgroup|See primary endpoint for previously defined description
142140|NCT01600014|O1|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|See primary endpoint for previously defined description
142141|NCT01600014|O5|Outcome|Vehicle Gel Field Recurrent Subgroup|See primary endpoint for previously defined description
142142|NCT01600014|O4|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|See primary endpoint for previously defined description
142146|NCT01600014|O4|Outcome|Vehicle Gel Field Recurrent Subgroup|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with vehicle gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 26 or Week 44 with follow-up until Week 52
142147|NCT01600014|O3|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 26 or Week 44 with follow-up until Week 52
142148|NCT01600014|O2|Outcome|Vehicle Gel Field Recalcitrant Subgroup|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with vehicle gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 8 with follow-up until Week 52
142149|NCT01600014|O1|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 8 with follow-up until Week 52
142150|NCT01600014|E3|Reported Event|Vehicle Gel (2. Cycle)|Repeat use once daily for 3 consecutive days with vehicle gel of the same treatment area (25 cm2 treatment area on the face or scalp) in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup)
142151|NCT01600014|E2|Reported Event|Ingenol Mebutate 0.015% Gel (2. Cycle)|Repeat use once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (25 cm2 treatment area on the face or scalp) in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup)
142152|NCT01600014|E1|Reported Event|Ingenol Mebutate 0.015% Gel (1. Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel within a 25 cm2 treatment area on the face or scalp
142153|NCT01599832|B1|Baseline|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging
pharmacogenomic studies: Correlative studies"
142154|NCT01599832|P1|Participant Flow|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging
pharmacogenomic studies: Correlative studies"
142155|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging
pharmacogenomic studies: Correlative studies"
142216|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142217|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142218|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142219|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142156|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging
pharmacogenomic studies: Correlative studies"
142157|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging
pharmacogenomic studies: Correlative studies"
142158|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging
pharmacogenomic studies: Correlative studies"
142159|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging
pharmacogenomic studies: Correlative studies"
142160|NCT01599832|E1|Reported Event|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging
pharmacogenomic studies: Correlative studies"
142161|NCT01599806|B3|Baseline|Total|Total of all reporting groups
142162|NCT01599806|B2|Baseline|Doripenem|Doripenem treatment group
142163|NCT01599806|B1|Baseline|CAZ-AVI|Ceftazidime-avibactam treatment group
142167|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142168|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142169|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142170|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142171|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142172|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142173|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142174|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142175|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142176|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142177|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142178|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142179|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142180|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142181|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142182|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142183|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142184|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142185|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142186|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142187|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142188|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142189|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142190|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142191|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142192|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142193|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142194|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142195|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142196|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142197|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142198|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142199|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142200|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142201|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142202|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142203|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142204|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142205|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142206|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142207|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142208|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142209|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142210|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142211|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142212|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142229|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142230|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142231|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142232|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142233|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142234|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142235|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142236|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142237|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142238|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142239|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142240|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142241|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142242|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142243|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142244|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142245|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142246|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142247|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142248|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142249|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142250|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142251|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142252|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142253|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142254|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142255|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142256|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142257|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142258|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142259|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142260|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142261|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142262|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142263|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142265|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142266|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142267|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142268|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142269|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142270|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142271|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142272|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142273|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142274|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142275|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142276|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142277|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142278|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142279|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142280|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142281|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142282|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142283|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142284|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
142285|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142286|NCT01599806|E2|Reported Event|Doripenem|Doripenem treatment group
142287|NCT01599806|E1|Reported Event|CAZ-AVI|Ceftazidime-avibactam treatment group
142288|NCT01599741|B1|Baseline|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ
142289|NCT01599741|P1|Participant Flow|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper directly followed by DSA with ClarityIQ
142290|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
142291|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
142292|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
142293|NCT01599741|E1|Reported Event|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ
142294|NCT01599650|B4|Baseline|Total|Total of all reporting groups
142295|NCT01599650|B3|Baseline|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
142296|NCT01599650|B2|Baseline|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142297|NCT01599650|B1|Baseline|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142298|NCT01599650|P3|Participant Flow|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
142299|NCT01599650|P2|Participant Flow|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142300|NCT01599650|P1|Participant Flow|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142301|NCT01599650|O1|Outcome|3- Laser Monotherapy|laser therapy + Ranibizumab 0.5 mg after Month 6
142302|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
142303|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142304|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142305|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
142306|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142307|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142308|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
142309|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142310|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142311|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
142312|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142313|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142314|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
142315|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142316|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142317|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
142318|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142319|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142320|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
142321|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142322|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142323|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142324|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142325|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
142326|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142327|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142328|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
142329|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
142330|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
142331|NCT01599650|E4|Reported Event|Laser Monotherapy Without Ranibizumab 0.5 mg From Month 6|Laser monotherapy without Ranibizumab 0.5 mg from Month 6
142385|NCT01599585|B3|Baseline|Total|Total of all reporting groups
142332|NCT01599650|E3|Reported Event|Laser Monotherapy With Ranibizumab 0.5 mg From Month 6|Laser monotherapy with Ranibizumab 0.5 mg from Month 6
142333|NCT01599650|E2|Reported Event|Ranibizumab 0.5mg + Laser|"Ranibizumab 0.5mg + Laser
[1] Safety set was summarized based on actual treatment received. There were 3 laser monotherapy patients who received ranibizumab and 1 ranibizumab patient who received laser treatment which resulted in percentages > 100% for the ranibizumab + laser arm."
142334|NCT01599650|E1|Reported Event|Ranibizumab 0.5mg|Ranibizumab 0.5mg
142335|NCT01599637|B4|Baseline|Total|Total of all reporting groups
142336|NCT01599637|B3|Baseline|Healthy Volunteers|Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
142337|NCT01599637|B2|Baseline|Placebo to IGE025|Placebo administered subcutaneously every 4 weeks at the study center.
142338|NCT01599637|B1|Baseline|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142339|NCT01599637|P3|Participant Flow|Healthy Volunteers|Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
142340|NCT01599637|P2|Participant Flow|Placebo to IGE025|Placebo administered subcutaneously every 4 weeks at the study center.
142341|NCT01599637|P1|Participant Flow|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142342|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142343|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142344|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142345|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142346|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142347|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142348|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142349|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142350|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142351|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142352|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142353|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142354|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142355|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142356|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142357|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142358|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142359|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142360|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142361|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142362|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142363|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142364|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142365|NCT01599637|O2|Outcome|Urticaria Patients|All patients for study at baseline
142366|NCT01599637|O1|Outcome|Healthy Subjects|Baseline Value, healthy volunteers, no treatment applied
142367|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142368|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142369|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142370|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142371|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142372|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142373|NCT01599637|O2|Outcome|Placebo IGE025|Dosed every 4 weeks up to 12 weeks
142374|NCT01599637|O1|Outcome|IGE025|Dosed every 4 weeks up to 12 weeks
142375|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142376|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142377|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142378|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142379|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142380|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142381|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
142382|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
142383|NCT01599637|E2|Reported Event|Placebo|Placebo administered subcutaneously every 4 weeks at the study center.
142384|NCT01599637|E1|Reported Event|IGE025 300mg|IGE025 administered subcutaneously every 4 weeks at the study center
142386|NCT01599585|B2|Baseline|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142387|NCT01599585|B1|Baseline|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142388|NCT01599585|P2|Participant Flow|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142389|NCT01599585|P1|Participant Flow|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142390|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142391|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142430|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
145205|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
142392|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142393|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142394|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142395|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142396|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142474|NCT01599104|B1|Baseline|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142475|NCT01599104|P3|Participant Flow|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142397|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142398|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142399|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142400|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142401|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142402|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142403|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142404|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142405|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142406|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142407|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142408|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142409|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142410|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142411|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142412|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142413|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142414|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142415|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142416|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142417|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142418|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142419|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142420|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142421|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142422|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142423|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142424|NCT01599585|E2|Reported Event|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142425|NCT01599585|E1|Reported Event|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.
Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
142426|NCT01599325|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142427|NCT01599325|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142428|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142429|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142431|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142432|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142433|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142434|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142435|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142436|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142437|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142438|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142439|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142440|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142476|NCT01599104|P2|Participant Flow|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142441|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142442|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142443|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142444|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142445|NCT01599325|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
142446|NCT01599234|B3|Baseline|Total|Total of all reporting groups
142447|NCT01599234|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142448|NCT01599234|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142449|NCT01599234|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142450|NCT01599234|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142451|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142452|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142453|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142454|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142455|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142456|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142457|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142458|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142459|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142504|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142505|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142460|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142461|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142462|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142463|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142464|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142465|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142466|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142467|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142468|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142469|NCT01599234|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
142470|NCT01599234|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
142471|NCT01599104|B4|Baseline|Total|Total of all reporting groups
142472|NCT01599104|B3|Baseline|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142473|NCT01599104|B2|Baseline|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142477|NCT01599104|P1|Participant Flow|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142478|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142479|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142480|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142481|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142482|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142483|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142484|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142485|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142486|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142487|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142488|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142489|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142490|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142491|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142492|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142493|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142494|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142495|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142496|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142497|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142498|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142499|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142500|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142501|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142502|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142503|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142506|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142507|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142508|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142509|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142510|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142511|NCT01599104|E3|Reported Event|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
142512|NCT01599104|E2|Reported Event|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
142513|NCT01599104|E1|Reported Event|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
142514|NCT01598987|B1|Baseline|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart."
142515|NCT01598987|P1|Participant Flow|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart."
142516|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
142517|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
142518|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
142519|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
142520|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
142521|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
142522|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
142523|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
142524|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
142525|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
142526|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
142527|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
142528|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
142529|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
142530|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
142531|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
142532|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
142533|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
142534|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
142535|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
142536|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
142537|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
142538|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
142539|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
142540|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
142541|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
142542|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
142543|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
142544|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart."
142545|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart."
142546|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart."
142547|NCT01598987|E1|Reported Event|All Patients|All patients
142548|NCT01598779|B1|Baseline|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.
In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
142642|NCT01598064|P1|Participant Flow|GK#10|GK#10 1 pk tid for 8 weeks
142549|NCT01598779|P1|Participant Flow|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.
In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
142550|NCT01598779|O1|Outcome|Women With External Genital Warts|"Women age 15–45 attending an outpatient consultation at clinics of the investigators or at University of Buenos Aires, with a lesion suspected of being HPV related were eligible to enter in the study. The main manifestations of genital warts include cauliflower-like condylomata acuminata lesions, keratotic and smooth papular warts, subclinical flat warts, Patients previously vaccinated with commercially available vaccines (Gardasil™ or Cervarix™) were not invited to participate.
Inclusion criteria: women between 15 and 45 years old, with External Genital Warts. We will exclude women under treatment corticosteroids, having an immunosuppressive disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known"
142551|NCT01598779|E1|Reported Event|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.
In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
142552|NCT01598740|B3|Baseline|Total|Total of all reporting groups
142553|NCT01598740|B2|Baseline|CLP/CLP + Spiro|Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
142554|NCT01598740|B1|Baseline|CLP + Spiro/CLP|Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
142555|NCT01598740|P2|Participant Flow|CLP (7 Days), Washout (7 Days), CLP + Spiro (7 Days)|Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
142556|NCT01598740|P1|Participant Flow|CLP + Spiro (7 Days), Washout (7 Days), CLP (7 Days)|Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
142557|NCT01598740|O2|Outcome|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
142558|NCT01598740|O1|Outcome|Treatment Group: CLP Alone|CLP: oral administration
142559|NCT01598740|O2|Outcome|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
142560|NCT01598740|O1|Outcome|Treatment Group: CLP Alone|oral administration
142561|NCT01598740|E2|Reported Event|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
142562|NCT01598740|E1|Reported Event|Treatment Group: CLP Alone|oral administration
142563|NCT01598610|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
142564|NCT01598610|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
142565|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
142566|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
142567|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
142568|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
142569|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
142570|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
142571|NCT01598610|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
142572|NCT01598545|B1|Baseline|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
142573|NCT01598545|P1|Participant Flow|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
142574|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
142643|NCT01598064|O2|Outcome|Placebo: 8 Week|Placebo 1 pack three times per day for 8 weeks, and F/U ALT level.
142644|NCT01598064|O1|Outcome|GK#10: 8 Week|GK#10 1 pack three times per day for 8 weeks, and F/U ALT level.
142575|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
142576|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
142577|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
142578|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
142579|NCT01598545|E1|Reported Event|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally
Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
142580|NCT01598532|B1|Baseline|Transcranial LED Treatment|"All study subjects received LED treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy. Each session was 30 minutes in duration. Neuropsychological testing was administered at the following time points: within 1 week of the first LED treatment and within 1 week, 1 month & 2 months following the last LED treatment.
The neuropsychological testing included: 1)Stroop test, 2) California Verbal Learning Test-II (CVLT- II), Short Delay Free & Cued Recall, Long Delay Free & Cued Recall, 3) Delis-Kaplan Executive Function (D-KEF) -Trails Test, 4) Controlled Oral Word Association Test (FAS), & 5) Digit Span, Forwards & Backwards.
The following tests were not analyzed due to collinearity with other measures (r > .8): Short Delay Free & Cued Recall, Long Delay Cued Recall, & Delis-Kaplan Executive Function (D-KEF) -Trails Test."
142581|NCT01598532|P1|Participant Flow|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
142582|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
142583|NCT01598532|O1|Outcome|Transcranial LED Treatment|"All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each."
142584|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
142585|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.
142586|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
142587|NCT01598532|O1|Outcome|Transcranial LED Treatment|MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
142588|NCT01598532|E1|Reported Event|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.
142589|NCT01598506|B1|Baseline|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 12.7 mcg +/- 3.27."
142590|NCT01598506|P1|Participant Flow|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 12.7 mcg +/- 3.27."
142591|NCT01598506|O1|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 12.7 mcg +/- 3.27."
142592|NCT01598506|O1|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 12.7 mcg +/- 3.27."
142593|NCT01598506|O1|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 12.7 mcg +/- 3.27."
142594|NCT01598506|E1|Reported Event|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 12.7 mcg +/- 3.27."
142595|NCT01598428|B1|Baseline|Cataract|
142596|NCT01598428|P1|Participant Flow|Cataract|During cataract surgery, the anterior capsule was unpolished intraoperatively in one eye; the anterior capsule and the equator of capsule was extensively polished intraoperatively in the other eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
142645|NCT01598064|O2|Outcome|Placebo|Placebo 1 pack tid for 8 weeks
142646|NCT01598064|O1|Outcome|GK#10|GK#10 1 pk tid for 8 weeks
142647|NCT01598064|E2|Reported Event|Placebo|Placebo 1 pack tid for 8 weeks
142597|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
142598|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
142599|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
142600|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
142601|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
142602|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
142603|NCT01598428|E1|Reported Event|Cataract|
142604|NCT01598350|B1|Baseline|Orthotic|"Orthotic Use
Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
142605|NCT01598350|P1|Participant Flow|Orthotic|"Orthotic Use
Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
142606|NCT01598350|O1|Outcome|Orthotic|"Orthotic Use
Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
142607|NCT01598350|E1|Reported Event|Orthotic|"Orthotic Use
Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
142608|NCT01598207|B3|Baseline|Total|Total of all reporting groups
142609|NCT01598207|B2|Baseline|Placebo|Placebo: 5mg BID, orally for 1 month
142610|NCT01598207|B1|Baseline|Marinol|Marinol: 5mg BID, orally for 1 month
142611|NCT01598207|P2|Participant Flow|Placebo|Placebo: 5mg BID, orally for 1 month
142612|NCT01598207|P1|Participant Flow|Marinol|Marinol: 5mg BID, orally for 1 month
142613|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
142614|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
142615|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
142616|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
142617|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
142618|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
142619|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
142620|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
142621|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
142622|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
142623|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
142624|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
142625|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
142626|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
142627|NCT01598207|E2|Reported Event|Placebo|Placebo: 5mg BID, orally for 1 month
142628|NCT01598207|E1|Reported Event|Marinol|Marinol: 5mg BID, orally for 1 month
142629|NCT01598129|B1|Baseline|CGTG-102|"CGTG-102 dose escalation
CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
142630|NCT01598129|P1|Participant Flow|CGTG-102|"CGTG-102 dose escalation
CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
142631|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation
ONCOS-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
142632|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation
CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
142633|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation
CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
142634|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation
CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
142635|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation
CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
142636|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation
CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
142637|NCT01598129|E1|Reported Event|CGTG-102|"CGTG-102 dose escalation
CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
142638|NCT01598064|B3|Baseline|Total|Total of all reporting groups
142639|NCT01598064|B2|Baseline|Placebo|Placebo 1 pack tid for 8 weeks
142640|NCT01598064|B1|Baseline|GK#10|GK#10 1 pk tid for 8 weeks
142641|NCT01598064|P2|Participant Flow|Placebo|Placebo 1 pack tid for 8 weeks
142650|NCT01597908|B2|Baseline|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142651|NCT01597908|B1|Baseline|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142652|NCT01597908|P2|Participant Flow|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142653|NCT01597908|P1|Participant Flow|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 milligrams (mg) orally twice daily (BID) and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142654|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142655|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142656|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142657|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142658|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142659|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142660|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142661|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142662|NCT01597908|E2|Reported Event|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142663|NCT01597908|E1|Reported Event|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
142664|NCT01597843|B4|Baseline|Total|Total of all reporting groups
142665|NCT01597843|B3|Baseline|Education After Data Collection Complete|This group received a similar intervention, but after all quantitative data collection complete.
142666|NCT01597843|B2|Baseline|Second Intervention Group|"The group that receives the intervention second. The intervention is the same as for the first group.
Education: Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV."
142667|NCT01597843|B1|Baseline|First Educational Intervention Group|"Group that receives intervention first. The intervention is a series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV.
Education: Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV."
142668|NCT01597843|P3|Participant Flow|Control First Round; Control Second Round; Intervention|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
142669|NCT01597843|P2|Participant Flow|Control First Round; Education in Second Round|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 6-9. They completed survey rounds 1 and 2 before receiving the intervention and survey round 3 after they received the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
142703|NCT01597479|B1|Baseline|dPNBs Group|dPNBs on radial and median nerves at the elbow in postoperative period, before discharge
142704|NCT01597479|P2|Participant Flow|No Intervention (no dPNBs Group)|In patients of no dPNBs group didn't performed any intervention after surgery.
142861|NCT01597050|B1|Baseline|Drug: R932333|"R333 6% (60 mg/g), bid
R932333: R393233 6% (60 mg/g), bid"
142670|NCT01597843|P1|Participant Flow|Education in First Round|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 1-5. They completed survey round 1 before receiving the intervention and survey rounds 2 and 3 after receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
142671|NCT01597843|O3|Outcome|Control First Round; Control Second Round; Intervention|This group received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention.
142672|NCT01597843|O2|Outcome|Control First Round; Education in Second Round|The intervention was delivered to 3 groups of 4 posts in sequence. The posts in this second round received the intervention over the second study period, from month 6 through month 9. they completed survey rounds 1 and 2 before receiving the intervention, survey round 3 after.
142673|NCT01597843|O1|Outcome|Education in First Round|Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. This group received the intervention during study months 1-5, following survey 1, prior to survey rounds 2 and 3.
142674|NCT01597843|E3|Reported Event|Control First Round; Control Second Round; Intervention|This group received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention.
142675|NCT01597843|E2|Reported Event|Control First Round; Education in Second Round|The intervention was delivered to 3 groups of 4 posts in sequence. The posts in this second round received the intervention over the second study period, from month 6 through month 9. they completed survey rounds 1 and 2 before receiving the intervention, survey round 3 after.
142676|NCT01597843|E1|Reported Event|Education in First Round|Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. This group received the intervention during study months 1-5, following survey 1, prior to survey rounds 2 and 3.
142677|NCT01597596|B3|Baseline|Total|Total of all reporting groups
142678|NCT01597596|B2|Baseline|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142679|NCT01597596|B1|Baseline|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142680|NCT01597596|P2|Participant Flow|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142681|NCT01597596|P1|Participant Flow|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg intravenous (IV) infusion every other week (QOW) for 52 weeks.
147930|NCT01575899|B4|Baseline|Total|Total of all reporting groups
142682|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142683|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142684|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142685|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142686|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142687|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142688|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142689|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142690|NCT01597596|E2|Reported Event|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142691|NCT01597596|E1|Reported Event|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
142692|NCT01597492|B3|Baseline|Total|Total of all reporting groups
142693|NCT01597492|B2|Baseline|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
142694|NCT01597492|B1|Baseline|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
142695|NCT01597492|P2|Participant Flow|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
142696|NCT01597492|P1|Participant Flow|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
142697|NCT01597492|O2|Outcome|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
142698|NCT01597492|O1|Outcome|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
142699|NCT01597492|E2|Reported Event|Belimumab Plus Late Vaccination|Belimumab plus Late Vaccination
142700|NCT01597492|E1|Reported Event|Belimumab Plus Early Vaccination|Belimumab plus Early Vaccination
142701|NCT01597479|B3|Baseline|Total|Total of all reporting groups
142702|NCT01597479|B2|Baseline|Non dPNBs Group|Non intervention in postoperative period
142705|NCT01597479|P1|Participant Flow|Distal Peripheral Nerve Blocks Group (dPNBs Group)|"In dPNBs group, we practice distal peripheral nerves blocks guided by ultrasound and neurostimulator.
Levobupivacaine: In dPNBs group, we practice ultrasound guided distal peripheral nerve blocks on radial and median nerves using low volume and low concentration of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve).
We performed dPNBs in the postoperative period. Deffered dPNBs under the influence of axillary block didn't cause patient disconfort. We considered the technique safety due to ultrasound guidance."
142706|NCT01597479|O2|Outcome|Non dPNBs Group|In this group any intervention was done.
142707|NCT01597479|O1|Outcome|dPNBs Group|we practiced ultrasound guided dPNBs on radial and median nerves using a long acting and low concentration local anesthetic (0.125% levobupivacaine, 5 ml per nerve).
142708|NCT01597479|O2|Outcome|Non Distal Peripheral Nerve Blocks (Non dPNBs Group)|Patients in non dPNBs didn't received any intervention in the postoperatively period.
142709|NCT01597479|O1|Outcome|Distal Peripheral Nerve Blocks Group (dPNBs Group)|"We practiced ultrasound guided dPNBs on radial and median nerves, after surgery, before discharge.
Distal median nerve block was performed at the elbow, in the internal bicipital channel.
Distal radial nerve block was performed at approximately the junction of the middle and distal thirds of the arm.
We use 5ml per nerve of levobupivacaine 0,125% for target nerve blocks."
142710|NCT01597479|E1|Reported Event|Distal Peripheral Nerve Block Group|Any patient undergoing ultrasound guided distal peripheral nerve block reported any complication.
142711|NCT01597440|B3|Baseline|Total|Total of all reporting groups
142712|NCT01597440|B2|Baseline|Placebo|"Standard of Care therapy
Standard of Care: Standard of Care"
142713|NCT01597440|B1|Baseline|Carbaglu|"Active NCG & Standard of Care
N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).
The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.
This drug will be administered for 7 days after admission or until discharge (whichever is sooner).
Standard of Care: Standard of Care"
142714|NCT01597440|P2|Participant Flow|Placebo|"Standard of Care therapy
Standard of Care: Standard of Care"
142734|NCT01597245|P6|Participant Flow|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56.
142715|NCT01597440|P1|Participant Flow|Carbaglu|"Active NCG & Standard of Care
N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).
The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.
This drug will be administered for 7 days after admission or until discharge (whichever is sooner).
Standard of Care: Standard of Care"
142716|NCT01597440|O2|Outcome|Placebo|"Standard of Care Therapy
Standard of Care: Standard of Care"
142717|NCT01597440|O1|Outcome|Carbaglu|"Active NCG & Standard of Care
N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG)
The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).
The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.
This drug will be administered for 7 days after admission or until discharge (whichever is sooner).
Standard of Care: Standard of Care"
142718|NCT01597440|O2|Outcome|Placebo|"Standard of Care therapy
Standard of Care: Standard of Care"
142719|NCT01597440|O1|Outcome|Carbaglu|"Active NCG & Standard of Care
N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).
The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.
This drug will be administered for 7 days after admission or until discharge (whichever is sooner).
Standard of Care: Standard of Care"
142720|NCT01597440|E2|Reported Event|Placebo|"Standard of Care therapy
Standard of Care: Standard of Care"
142721|NCT01597440|E1|Reported Event|Carbaglu|"Active NCG & Standard of Care
N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).
The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.
This drug will be administered for 7 days after admission or until discharge (whichever is sooner).
Standard of Care: Standard of Care"
142722|NCT01597245|B5|Baseline|Total|Total of all reporting groups
142723|NCT01597245|B4|Baseline|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142724|NCT01597245|B3|Baseline|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142725|NCT01597245|B2|Baseline|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142726|NCT01597245|B1|Baseline|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142727|NCT01597245|P13|Participant Flow|Ixe Q2W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142728|NCT01597245|P12|Participant Flow|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142729|NCT01597245|P11|Participant Flow|ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142730|NCT01597245|P10|Participant Flow|ETN Resp/Placebo Maintenance Period Secondary Pop|Participants who received ETN during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
142731|NCT01597245|P9|Participant Flow|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142732|NCT01597245|P8|Participant Flow|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
142733|NCT01597245|P7|Participant Flow|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142735|NCT01597245|P5|Participant Flow|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
148196|NCT01574105|B3|Baseline|Total|Total of all reporting groups
142736|NCT01597245|P4|Participant Flow|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12
142737|NCT01597245|P3|Participant Flow|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W:Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142738|NCT01597245|P2|Participant Flow|50 mg Etanercept (ETN) - Induction Period|50 milligrams (mg) ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142739|NCT01597245|P1|Participant Flow|Placebo- Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142740|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142741|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142742|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142743|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142744|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142745|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142746|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142747|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142748|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142854|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142749|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142750|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142751|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142752|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142753|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142754|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142755|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142756|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142757|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142758|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142873|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
142759|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142760|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142761|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142762|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142763|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142764|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142765|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142766|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142767|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142768|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142769|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142770|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142771|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142772|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142855|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142773|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142774|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142775|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142776|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142777|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142778|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142779|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142780|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142781|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142782|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142783|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142784|NCT01597245|O3|Outcome|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142785|NCT01597245|O2|Outcome|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56 .
142786|NCT01597245|O1|Outcome|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
142787|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142788|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142789|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142790|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142791|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142792|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142793|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142794|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142795|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142856|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142796|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142797|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142798|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142799|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142800|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142801|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142802|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142803|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142804|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142805|NCT01597245|O2|Outcome|50 mg Etanercept (ETN) - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142806|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142807|NCT01597245|E14|Reported Event|Ixe Q4W Maintenance Period Relapsed Pop|Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142808|NCT01597245|E13|Reported Event|Ixe Q2W NonResp/Ixe Q4W Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142809|NCT01597245|E12|Reported Event|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142810|NCT01597245|E11|Reported Event|ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142811|NCT01597245|E10|Reported Event|ETN Resp/Placebo Maintenance Period Secondary Pop|Participants who received ETN during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
142812|NCT01597245|E9|Reported Event|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142813|NCT01597245|E8|Reported Event|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
142814|NCT01597245|E7|Reported Event|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
142815|NCT01597245|E6|Reported Event|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56.
142816|NCT01597245|E5|Reported Event|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
142817|NCT01597245|E4|Reported Event|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142857|NCT01597128|E2|Reported Event|Strattice|"Use of a second mesh type
Strattice: Strattice mash for hernia repair"
142858|NCT01597128|E1|Reported Event|Flex HD|"Mesh Type
Flex HD: Flex HD mesh for hernia repair"
142818|NCT01597245|E3|Reported Event|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W): (Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
142819|NCT01597245|E2|Reported Event|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
142820|NCT01597245|E1|Reported Event|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
142821|NCT01597141|B3|Baseline|Total|Total of all reporting groups
142822|NCT01597141|B2|Baseline|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
142823|NCT01597141|B1|Baseline|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
142824|NCT01597141|P2|Participant Flow|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
142825|NCT01597141|P1|Participant Flow|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
142826|NCT01597141|O2|Outcome|Enhanced Standard Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
143065|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142827|NCT01597141|O1|Outcome|Family-aided Assertive Community Treatment|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
142828|NCT01597141|O2|Outcome|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
142829|NCT01597141|O1|Outcome|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
142830|NCT01597141|E2|Reported Event|Enhanced Standard Treatment|In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
142831|NCT01597141|E1|Reported Event|Family-aided Assertive Community Treatment|The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
142832|NCT01597128|B3|Baseline|Total|Total of all reporting groups
142833|NCT01597128|B2|Baseline|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142834|NCT01597128|B1|Baseline|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142835|NCT01597128|P2|Participant Flow|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142836|NCT01597128|P1|Participant Flow|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142837|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142838|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142839|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142840|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142841|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142842|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142843|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142844|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142845|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142846|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142847|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142848|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142849|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142850|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142851|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142852|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
142853|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
142859|NCT01597050|B3|Baseline|Total|Total of all reporting groups
142862|NCT01597050|P2|Participant Flow|Placebo|"Placebo, bid
Placebo: Placebo, bid"
142863|NCT01597050|P1|Participant Flow|Drug: R932333|"R333 6% (60 mg/g), bid
R932333: R393233 6% (60 mg/g), bid"
142864|NCT01597050|O2|Outcome|Placebo|"Placebo, bid
Placebo: Placebo, bid"
142865|NCT01597050|O1|Outcome|Drug: R932333|"R333 6% (60 mg/g), bid
R932333: R393233 6% (60 mg/g), bid"
142866|NCT01597050|E2|Reported Event|Placebo|"Placebo, bid
Placebo: Placebo, bid"
142867|NCT01597050|E1|Reported Event|Drug: R932333|"R333 6% (60 mg/g), bid
R932333: R393233 6% (60 mg/g), bid"
142868|NCT01596972|B3|Baseline|Total|Total of all reporting groups
142869|NCT01596972|B2|Baseline|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
142870|NCT01596972|B1|Baseline|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week
dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
142871|NCT01596972|P2|Participant Flow|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
142872|NCT01596972|P1|Participant Flow|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week
dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
143066|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
142874|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week
dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
142875|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
142876|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week
dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
142877|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
142878|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week
dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
142879|NCT01596972|E2|Reported Event|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
142880|NCT01596972|E1|Reported Event|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week
dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
142881|NCT01596842|B3|Baseline|Total|Total of all reporting groups
143042|NCT01595854|O5|Outcome|Dabigatran 75 mg - Part 3|A single dose of Dabigatran etexilate 75 mg
142882|NCT01596842|B2|Baseline|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
142883|NCT01596842|B1|Baseline|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
142884|NCT01596842|P2|Participant Flow|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
142885|NCT01596842|P1|Participant Flow|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
142886|NCT01596842|O2|Outcome|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
142887|NCT01596842|O1|Outcome|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
142888|NCT01596842|O2|Outcome|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
142889|NCT01596842|O1|Outcome|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
142952|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142890|NCT01596842|E2|Reported Event|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
142891|NCT01596842|E1|Reported Event|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
142892|NCT01596582|B3|Baseline|Total|Total of all reporting groups
142893|NCT01596582|B2|Baseline|Risk Assessment|"Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%)versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, >20 years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never)."
142894|NCT01596582|B1|Baseline|Standard Care|Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.
142895|NCT01596582|P2|Participant Flow|Risk Assessment|"Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) and the ACNI risk assessment tool just prior to a scheduled office visit with their provider.
Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%)versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, >20 years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never)."
142896|NCT01596582|P1|Participant Flow|Standard Care|Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.
142897|NCT01596582|O2|Outcome|Low Risk|Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).
142898|NCT01596582|O1|Outcome|High Risk|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%)
142899|NCT01596582|O2|Outcome|Low Risk|Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).
142900|NCT01596582|O1|Outcome|High Risk|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%)
142901|NCT01596582|O2|Outcome|Risk Assessment|Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
142902|NCT01596582|O1|Outcome|Standard Care|Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
142903|NCT01596582|O2|Outcome|Risk Assessment|Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
142904|NCT01596582|O1|Outcome|Standard Care|Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
142905|NCT01596582|O2|Outcome|Posttest|Provider responses to the same 3-item posttest administered after completion of study enrollment. Provider responses to a 3-item pretest administered prior the commencement of the study.
142906|NCT01596582|O1|Outcome|Pretest|Provider responses to a 3-item pretest administered prior the commencement of the study.
142907|NCT01596582|O2|Outcome|Discordance|The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.
142908|NCT01596582|O1|Outcome|Concordance|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category.
142909|NCT01596582|O2|Outcome|Discordance|The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.
142910|NCT01596582|O1|Outcome|Concordance|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category.
142911|NCT01596582|O2|Outcome|Discordance|The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.
142912|NCT01596582|O1|Outcome|Concordance|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category.
142913|NCT01596582|O2|Outcome|Low Risk|Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).
142914|NCT01596582|O1|Outcome|High Risk|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%)
142915|NCT01596582|O2|Outcome|Risk Assessment|Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
142916|NCT01596582|O1|Outcome|Standard Care|Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
142917|NCT01596582|E2|Reported Event|Risk Assessment|Subjects randomized to the experimental arm will complete the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
151685|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
142918|NCT01596582|E1|Reported Event|Standard Care|Subjects randomized to the experimental arm will review the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
142919|NCT01596504|B4|Baseline|Total|Total of all reporting groups
142920|NCT01596504|B3|Baseline|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142921|NCT01596504|B2|Baseline|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142922|NCT01596504|B1|Baseline|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142923|NCT01596504|P3|Participant Flow|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142924|NCT01596504|P2|Participant Flow|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142925|NCT01596504|P1|Participant Flow|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg once daily (QD) for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142926|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142927|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142928|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142929|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142930|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142931|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142932|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142933|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142934|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142935|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142936|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142937|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142938|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142939|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142940|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142941|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142942|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142943|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142944|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142945|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142946|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142947|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142948|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142949|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142950|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142951|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142953|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142954|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142955|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142956|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142957|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142958|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142959|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142960|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142961|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142962|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142963|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142964|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142965|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142966|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142967|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142968|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142969|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142970|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142971|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
143043|NCT01595854|O4|Outcome|Ticagrelor 180 mg - Part 2|A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test.
142972|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142973|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142974|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142975|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142976|NCT01596504|O1|Outcome|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142977|NCT01596504|E3|Reported Event|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
142978|NCT01596504|E2|Reported Event|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
142979|NCT01596504|E1|Reported Event|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
142980|NCT01596231|B3|Baseline|Total|Total of all reporting groups
142981|NCT01596231|B2|Baseline|Kudzu|"Kudzu 2mg
Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
142982|NCT01596231|B1|Baseline|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.
Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
142983|NCT01596231|P2|Participant Flow|Kudzu|"Kudzu 2mg
Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
143020|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
151686|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
142984|NCT01596231|P1|Participant Flow|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.
Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
142985|NCT01596231|O2|Outcome|Kudzu|Kudzu extract treatment significantly reduced the number of beers opened and total amounts (weight and volume) consumed. Latency and time to consume a beer was not significantly altered, and there was no difference in the number of sips taken to drink a beer.
142986|NCT01596231|O1|Outcome|Placebo|Placebo did not alter alcohol consumption compared to baseline.
142987|NCT01596231|E2|Reported Event|Kudzu|"Kudzu 2mg
Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
142988|NCT01596231|E1|Reported Event|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.
Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
142989|NCT01596088|B1|Baseline|Dexrazoxane|
142990|NCT01596088|P1|Participant Flow|Dexrazoxane|
142991|NCT01596088|O1|Outcome|Dexrazoxane|
142992|NCT01596088|E1|Reported Event|Dexrazoxane|
142993|NCT01596062|B4|Baseline|Total|Total of all reporting groups
142994|NCT01596062|B3|Baseline|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
142995|NCT01596062|B2|Baseline|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
142996|NCT01596062|B1|Baseline|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
142997|NCT01596062|P3|Participant Flow|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
142998|NCT01596062|P2|Participant Flow|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
142999|NCT01596062|P1|Participant Flow|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
143000|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
143001|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
143002|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
143003|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
143004|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
143005|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
143006|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
143044|NCT01595854|O3|Outcome|Dabigatran 220 mg - Part 2|A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
143007|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
143008|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
143009|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
143010|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
143011|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
143012|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
143013|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
143014|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
143015|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
143016|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
143017|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
143018|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
143019|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
143064|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
151687|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
143021|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
143022|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
143023|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
143024|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
143025|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
143026|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
143027|NCT01596062|E3|Reported Event|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
143028|NCT01596062|E2|Reported Event|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
143029|NCT01596062|E1|Reported Event|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
143030|NCT01595854|B6|Baseline|Total|Total of all reporting groups
143031|NCT01595854|B5|Baseline|Dabigatran Etexilate / Multiple Dose Ticagrelor - Part 3|"A randomised two-period cross-over trial, the two treatments administered were
A single dose of dabigatran etexilate 75 mg
Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered with a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
Between treatment periods there was a washout period of at least 4 days."
143032|NCT01595854|B4|Baseline|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
143033|NCT01595854|B3|Baseline|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
143034|NCT01595854|B2|Baseline|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
143035|NCT01595854|B1|Baseline|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
143036|NCT01595854|P5|Participant Flow|Dabigatran Etexilate/Multiple Dose Ticagrelor Crossover-Part 3|"A randomised, two-period, cross-over trial, the two treatments administered were
A single dose of dabigatran etexilate 75 mg
Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
Between treatment periods there was a washout period of at least 4 days."
143037|NCT01595854|P4|Participant Flow|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
143038|NCT01595854|P3|Participant Flow|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
143039|NCT01595854|P2|Participant Flow|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
143040|NCT01595854|P1|Participant Flow|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
143041|NCT01595854|O6|Outcome|Dabigatran + Ticagrelor - Part 3|Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
143045|NCT01595854|O2|Outcome|Ticagrelor 180 mg - Part 1|A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
143046|NCT01595854|O1|Outcome|Dabigatran 220 mg - Part 1|A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
143047|NCT01595854|O3|Outcome|Dabi + Ticagrelor MD|A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (LD) ticagrelor.
143048|NCT01595854|O2|Outcome|Dabi + Ticagrelor LD|A single dose of 75 mg Dabigatran coadministered with a loading dose (LD) of 180 mg ticagrelor coated tablets (T).
143049|NCT01595854|O1|Outcome|Dabi 75 mg|A single dose of Dabigatran etexilate (Dabi) 75 mg.
143050|NCT01595854|O3|Outcome|Dabi + Ticagrelor MD|A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (MD) ticagrelor.
143051|NCT01595854|O2|Outcome|Dabi + Ticagrelor LD|A single dose of 75 mg Dabigatran coadministered with a loading dose (LD) of 180 mg ticagrelor coated tablets (T).
143052|NCT01595854|O1|Outcome|Dabi 75 mg|A single dose of Dabigatran etexilate (Dabi) 75 mg.
143053|NCT01595854|E6|Reported Event|Multiple Dose Ticagrelor - Part 3|Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
143054|NCT01595854|E5|Reported Event|Dabi 75 mg - Part 3|A single dose of dabigatran etexilate (Dabi) 75 mg
143055|NCT01595854|E4|Reported Event|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
143056|NCT01595854|E3|Reported Event|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
143057|NCT01595854|E2|Reported Event|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
143058|NCT01595854|E1|Reported Event|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
143059|NCT01595438|B3|Baseline|Total|Total of all reporting groups
143060|NCT01595438|B2|Baseline|Doripenem|Doripenem treatment group
143061|NCT01595438|B1|Baseline|CAZ-AVI|Ceftazidime-avibactam treatment group
143062|NCT01595438|P2|Participant Flow|Doripenem|Doripenem treatment group
143063|NCT01595438|P1|Participant Flow|CAZ-AVI|Ceftazidime-avibactam treatment group
143067|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143068|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143069|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143070|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143071|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143072|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143073|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143074|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143075|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143076|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143077|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143078|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143079|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143080|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143081|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143082|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143083|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143084|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143085|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143086|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143087|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143088|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143089|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143090|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143091|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143092|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143093|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143094|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143095|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143096|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143097|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143098|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143099|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143100|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143101|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143102|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143103|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143104|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143105|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143106|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143107|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143108|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143109|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143110|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143111|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143112|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143113|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143115|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143116|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143117|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143118|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143119|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143120|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143121|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143122|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143123|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143124|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143125|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143126|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143127|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143128|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143129|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143130|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143131|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143132|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143133|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143134|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143135|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143136|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143137|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143138|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143139|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143140|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143141|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143142|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143143|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143144|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143145|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143146|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143147|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143148|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143149|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143150|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143151|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143152|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143153|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143154|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143155|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143156|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143157|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143158|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143159|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143160|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143161|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143162|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143163|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143164|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143165|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143166|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143167|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143168|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143169|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143170|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143171|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143172|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143173|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143174|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143175|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143176|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143177|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143178|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143179|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143180|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143181|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143182|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
143183|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
143184|NCT01595438|E2|Reported Event|Doripenem|Doripenem treatment group
143185|NCT01595438|E1|Reported Event|CAZ-AVI|Ceftazidime-avibactam treatment group
143186|NCT01595386|B3|Baseline|Total|Total of all reporting groups
143187|NCT01595386|B2|Baseline|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143230|NCT01594970|B2|Baseline|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
143188|NCT01595386|B1|Baseline|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143189|NCT01595386|P2|Participant Flow|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of cardiopulmonary bypass (CPB) and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143190|NCT01595386|P1|Participant Flow|Normal Saline|"The subjects will receive a bolus after successful completion of bypass and the post-pump adrenocorticotrophic hormone (ACTH) stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143191|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143192|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143247|NCT01594970|E3|Reported Event|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
143248|NCT01594970|E2|Reported Event|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
143193|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143194|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143195|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143196|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143197|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143198|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143199|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143200|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143231|NCT01594970|B1|Baseline|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
143232|NCT01594970|P3|Participant Flow|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
143201|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143202|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143203|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143204|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143205|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143206|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143207|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143208|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143209|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143210|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143211|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143212|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143213|NCT01595386|E2|Reported Event|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.
Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
143233|NCT01594970|P2|Participant Flow|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
143582|NCT01593215|E2|Reported Event|Yohimbine|"Yohimbine
Yohimbine: Yohimbine capsule"
143214|NCT01595386|E1|Reported Event|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.
Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
143215|NCT01595282|B3|Baseline|Total|Total of all reporting groups
143216|NCT01595282|B2|Baseline|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo
Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
143217|NCT01595282|B1|Baseline|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)
Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
143218|NCT01595282|P2|Participant Flow|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo
Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
143219|NCT01595282|P1|Participant Flow|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)
Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
143220|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo
Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
143221|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)
Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
143222|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo
Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
143223|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)
Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
143224|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo
Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
143225|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)
Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
143226|NCT01595282|E2|Reported Event|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo
Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
143227|NCT01595282|E1|Reported Event|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)
Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
143228|NCT01594970|B4|Baseline|Total|Total of all reporting groups
143229|NCT01594970|B3|Baseline|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
143583|NCT01593215|E1|Reported Event|Placebo|"placebo
Yohimbine: Yohimbine capsule"
143234|NCT01594970|P1|Participant Flow|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
143235|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
143236|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
143237|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
143238|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
143239|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
143240|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
143241|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
143242|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
143243|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
143244|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
143245|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
143246|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
143249|NCT01594970|E1|Reported Event|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
143250|NCT01594762|B3|Baseline|Total|Total of all reporting groups
143251|NCT01594762|B2|Baseline|Topical Placebo Control|"Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment
Standard wound care: 28-day trial period"
143252|NCT01594762|B1|Baseline|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment
Standard wound care: 28-day trial period"
143253|NCT01594762|P2|Participant Flow|Topical Placebo Control|"Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)
Standard wound care: 28-day trial period"
143254|NCT01594762|P1|Participant Flow|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period)
Standard wound care: 28-day trial period"
143255|NCT01594762|O2|Outcome|Topical Placebo Control|"Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment"
143256|NCT01594762|O1|Outcome|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment"
143257|NCT01594762|O2|Outcome|Topical Placebo Control|"Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment"
143258|NCT01594762|O1|Outcome|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment"
143259|NCT01594762|O2|Outcome|Topical Placebo Control|"Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment"
143260|NCT01594762|O1|Outcome|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment"
143261|NCT01594762|E2|Reported Event|Topical Placebo Control|"Drug: Topical placebo cream
Topical placebo cream: 14 days of treatment"
143262|NCT01594762|E1|Reported Event|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%: 14 days of treatment"
143263|NCT01594749|B3|Baseline|Total|Total of all reporting groups
143264|NCT01594749|B2|Baseline|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143265|NCT01594749|B1|Baseline|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143584|NCT01592864|B3|Baseline|Total|Total of all reporting groups
143266|NCT01594749|P2|Participant Flow|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143267|NCT01594749|P1|Participant Flow|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-hydroxytryptamine 3 (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143268|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143299|NCT01594515|P4|Participant Flow|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143300|NCT01594515|P3|Participant Flow|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143397|NCT01594411|O4|Outcome|Invasive Angiography|Physician decision for invasive coronary angiography after receiving patients' GES
143269|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143270|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143271|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143272|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143273|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143285|NCT01594515|B8|Baseline|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143286|NCT01594515|B7|Baseline|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
145206|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
143274|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143275|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143276|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
151688|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
143277|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143278|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143279|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143280|NCT01594749|E2|Reported Event|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143281|NCT01594749|E1|Reported Event|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
143282|NCT01594515|B11|Baseline|Total|Total of all reporting groups
143283|NCT01594515|B10|Baseline|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
143284|NCT01594515|B9|Baseline|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143287|NCT01594515|B6|Baseline|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143288|NCT01594515|B5|Baseline|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143289|NCT01594515|B4|Baseline|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143290|NCT01594515|B3|Baseline|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143291|NCT01594515|B2|Baseline|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143292|NCT01594515|B1|Baseline|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143293|NCT01594515|P10|Participant Flow|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
143294|NCT01594515|P9|Participant Flow|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143295|NCT01594515|P8|Participant Flow|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143296|NCT01594515|P7|Participant Flow|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143297|NCT01594515|P6|Participant Flow|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143298|NCT01594515|P5|Participant Flow|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143301|NCT01594515|P2|Participant Flow|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143302|NCT01594515|P1|Participant Flow|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143303|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143304|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143305|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143306|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143307|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143308|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143309|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143310|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143311|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143312|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143313|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143314|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143315|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143316|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143317|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143318|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143319|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143320|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143321|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
145207|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
143322|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143323|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143324|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143325|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143326|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143327|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143328|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143329|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143330|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143331|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
143332|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143333|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143334|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143335|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143336|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143337|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143338|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143339|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143340|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143341|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
143342|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143343|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143344|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143345|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143346|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143347|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143348|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143349|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143350|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143351|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
143352|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143353|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143354|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143355|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143356|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143647|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143357|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143358|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143359|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143360|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143361|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
143362|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143363|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143364|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143365|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143366|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143367|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143368|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143369|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143370|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143371|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
143372|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143373|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143374|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143375|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143376|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143377|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143378|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143379|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143380|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143381|NCT01594515|E10|Reported Event|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143382|NCT01594515|E9|Reported Event|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143383|NCT01594515|E8|Reported Event|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143384|NCT01594515|E7|Reported Event|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143385|NCT01594515|E6|Reported Event|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143386|NCT01594515|E5|Reported Event|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143387|NCT01594515|E4|Reported Event|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143388|NCT01594515|E3|Reported Event|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143389|NCT01594515|E2|Reported Event|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
143390|NCT01594515|E1|Reported Event|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
143416|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143648|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143391|NCT01594424|B1|Baseline|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
143392|NCT01594424|P1|Participant Flow|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
143393|NCT01594424|O1|Outcome|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
143394|NCT01594424|E1|Reported Event|IVIG + Tocilizumab|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
143395|NCT01594411|B1|Baseline|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
143396|NCT01594411|P1|Participant Flow|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
143398|NCT01594411|O3|Outcome|Stress Test|Physician decision for stress testing (with or without imaging) or computed tomography/coronary angiography after receiving patients' GES
143399|NCT01594411|O2|Outcome|Medical Therapy|Physician decision for lifestyle changes or medical therapy after receiving patients' GES
143400|NCT01594411|O1|Outcome|No Tests/Treatment|Physician decision for no additional tests or cardiac treatment after receiving patients' GES
143401|NCT01594411|E1|Reported Event|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
143402|NCT01594385|B3|Baseline|Total|Total of all reporting groups
143403|NCT01594385|B2|Baseline|No Seprafilm|Patients in this group will not receive Seprafilm during re-operations. Otherwise, their surgical management will be identical to the Seprafilm Group.
143404|NCT01594385|B1|Baseline|Seprafilm|"The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in approximately 1:1 ratio.
Seprafilm: Two sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas:
Two Seprafilm pieces between the liver and the anterior abdominal wall
Four pieces over the exposed bowel surfaces anteriorly
Two slightly staggered pieces of Seprafilm in each colic gutter
Two pieces in the pelvic area.
If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair."
143405|NCT01594385|P2|Participant Flow|No Seprafilm Group|Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group.
143406|NCT01594385|P1|Participant Flow|Seprafilm Group|Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation.
143407|NCT01594385|O2|Outcome|No Seprafilm|Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
143408|NCT01594385|O1|Outcome|Seprafilm|Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25
143409|NCT01594385|E2|Reported Event|No Seprafilm Group|Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group.
143410|NCT01594385|E1|Reported Event|Seprafilm Group|Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation.
143411|NCT01594294|B3|Baseline|Total|Total of all reporting groups
143412|NCT01594294|B2|Baseline|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143413|NCT01594294|B1|Baseline|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143414|NCT01594294|P2|Participant Flow|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143415|NCT01594294|P1|Participant Flow|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
145208|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
143417|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143418|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143419|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143420|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143421|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143422|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143423|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143424|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143425|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143426|NCT01594294|E2|Reported Event|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143427|NCT01594294|E1|Reported Event|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
143428|NCT01594125|B6|Baseline|Total|Total of all reporting groups
143429|NCT01594125|B5|Baseline|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
143430|NCT01594125|B4|Baseline|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
143940|NCT01591616|O7|Outcome|Vital Signs (Systolic), 40 Minutes Post-dose|
143431|NCT01594125|B3|Baseline|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
143432|NCT01594125|B2|Baseline|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
143433|NCT01594125|B1|Baseline|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
143434|NCT01594125|P5|Participant Flow|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
143435|NCT01594125|P4|Participant Flow|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
143436|NCT01594125|P3|Participant Flow|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
143437|NCT01594125|P2|Participant Flow|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
143438|NCT01594125|P1|Participant Flow|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
143439|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
143440|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
143441|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
143442|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
143443|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
143444|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
143470|NCT01593852|B2|Baseline|Regular X-ray Dose Settings|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143445|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
143446|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
143447|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
143448|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
143449|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
143450|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
143451|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
143452|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
143453|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
143549|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose"
143550|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose"
143454|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
143455|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
143456|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
143457|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
143458|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
143459|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
143460|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
143461|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
143462|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
143463|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
143464|NCT01594125|E5|Reported Event|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
143465|NCT01594125|E4|Reported Event|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
143466|NCT01594125|E3|Reported Event|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
143467|NCT01594125|E2|Reported Event|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
143468|NCT01594125|E1|Reported Event|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
143469|NCT01593852|B3|Baseline|Total|Total of all reporting groups
145209|NCT01587079|O8|Outcome|GP MDI 18 μg (PT001)|18 μg
143471|NCT01593852|B1|Baseline|Reduced X-ray Dose Settings|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143472|NCT01593852|P2|Participant Flow|Regular X-ray Dose Settings|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143473|NCT01593852|P1|Participant Flow|Reduced X-ray Dose Settings|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143474|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143475|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143476|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143477|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143478|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143479|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143480|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143941|NCT01591616|O6|Outcome|Vital Signs (Systolic), 30 Minutes Post-dose|
143481|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143482|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143483|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143484|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143485|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143486|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143487|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143488|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143489|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143490|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143491|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143492|NCT01593852|E2|Reported Event|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
143493|NCT01593852|E1|Reported Event|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
143494|NCT01593787|B4|Baseline|Total|Total of all reporting groups
143495|NCT01593787|B3|Baseline|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
143496|NCT01593787|B2|Baseline|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
143497|NCT01593787|B1|Baseline|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
143498|NCT01593787|P3|Participant Flow|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
143499|NCT01593787|P2|Participant Flow|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
143500|NCT01593787|P1|Participant Flow|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
143501|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
143502|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
143503|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
143504|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
143505|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
143506|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
143507|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
143508|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
143509|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
143551|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose"
151818|NCT01559311|O3|Outcome|DDDR|Control Group – DDDR Standard Therapy
143510|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
143511|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
143512|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
143513|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
143514|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
143515|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
143516|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
143517|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
143518|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
143519|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
143520|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
143521|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
143522|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
143523|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
143524|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
143525|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
143526|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
143527|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
143528|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
143529|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
143530|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
143531|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
143532|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
143533|NCT01593787|E4|Reported Event|LCZ 200 mg|LCZ 200 mg
143534|NCT01593787|E3|Reported Event|Total LCZ696|All participants who received LCZ696
143535|NCT01593787|E2|Reported Event|LCZ 400 mg|LCZ 400 mg
143536|NCT01593787|E1|Reported Event|LCZ 100 mg|LCZ 100 mg
143537|NCT01593722|B3|Baseline|Total|Total of all reporting groups
143538|NCT01593722|B2|Baseline|SIngle Dose IVM|"ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose"
143539|NCT01593722|B1|Baseline|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose"
143540|NCT01593722|P2|Participant Flow|Single Dose IVM|"ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose"
143541|NCT01593722|P1|Participant Flow|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose"
143542|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose"
143543|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose"
143544|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose"
143545|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose"
143546|NCT01593722|O2|Outcome|Single Dose IVM|"ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose"
143547|NCT01593722|O1|Outcome|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose"
143548|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose"
143942|NCT01591616|O5|Outcome|Vital Signs (Systolic), 20 Minutes Post-dose|
143552|NCT01593722|E2|Reported Event|Ivermectin|"ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose"
143553|NCT01593722|E1|Reported Event|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose"
143554|NCT01593670|B1|Baseline|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.
Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.
Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15
Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17
Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
143555|NCT01593670|P1|Participant Flow|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.
Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.
Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15
Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17
Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
143556|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.
Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.
Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15
Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17
Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
143557|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.
Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.
Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15
Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17
Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
143558|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.
Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.
Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15
Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17
Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
143578|NCT01593215|P2|Participant Flow|Yohimbine First Then Placebo|Yohimbine first, 2 weeks washout and then placebo
143579|NCT01593215|P1|Participant Flow|Placebo First Then Yohimbine|Placebo first, then 2 weeks washout and then yohimbine
143580|NCT01593215|O2|Outcome|Yohimbine|"Yohimbine
Yohimbine: Yohimbine capsule"
143581|NCT01593215|O1|Outcome|Placebo|"placebo
Yohimbine: Yohimbine capsule"
143559|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.
Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.
Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15
Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17
Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
143560|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.
Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.
Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15
Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17
Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
143561|NCT01593670|E1|Reported Event|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.
Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.
Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15
Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17
Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
143562|NCT01593592|B3|Baseline|Total|Total of all reporting groups
143563|NCT01593592|B2|Baseline|Control Group|The control group that will receive the standard triple therapy and placebo
143943|NCT01591616|O4|Outcome|Vital Signs (Systolic), 10 Minutes Post-dose|
143564|NCT01593592|B1|Baseline|Lactobacillus Reuteri Group|The active group that will receive the standard triple therapy and Lactobacillus reuteri
143565|NCT01593592|P2|Participant Flow|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri
Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
143566|NCT01593592|P1|Participant Flow|Control Group|"The control group that will receive the standard triple therapy and placebo
Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
143567|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri
Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
143568|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo
Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
143569|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri
Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
143570|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo
Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
143571|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri
Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
143572|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo
Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
143573|NCT01593592|E2|Reported Event|Control Group|"The control group that will receive the standard triple therapy and placebo
Placebo: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
143574|NCT01593592|E1|Reported Event|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri
Lactobacillus reuteri: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
143575|NCT01593215|B3|Baseline|Total|Total of all reporting groups
143576|NCT01593215|B2|Baseline|Yohimbine First Then Yohimbine|Yohimbine first and then placebo
143577|NCT01593215|B1|Baseline|Placebo First Then Yohimbine|"placebo first
Yohimbine: Yohimbine capsule"
143585|NCT01592864|B2|Baseline|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143586|NCT01592864|B1|Baseline|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143587|NCT01592864|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP) Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143588|NCT01592864|P1|Participant Flow|Stannous Fluoride (SnF) Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 milliliter (mL) of water.
143589|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143590|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143591|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143592|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143593|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143594|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143595|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143596|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143597|NCT01592864|E2|Reported Event|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143598|NCT01592864|E1|Reported Event|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
143599|NCT01592851|B3|Baseline|Total|Total of all reporting groups
143600|NCT01592851|B2|Baseline|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
143601|NCT01592851|B1|Baseline|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
143602|NCT01592851|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP) Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% Sodium Monofluorophosphate [NaMFP]) for one timed minute, followed by rinsing with 5 mL of water.
143603|NCT01592851|P1|Participant Flow|Stannous Fluoride (SnF) Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
143604|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
143605|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
143606|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
143607|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
143608|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
143609|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
143610|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
143611|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
143612|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
143649|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143613|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
143614|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
143615|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
143616|NCT01592851|E2|Reported Event|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
143617|NCT01592851|E1|Reported Event|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
143618|NCT01592786|B1|Baseline|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
143619|NCT01592786|P1|Participant Flow|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
143620|NCT01592786|O1|Outcome|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg per day, based upon patient weight.
143621|NCT01592786|E1|Reported Event|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg, once per day, based upon patient weight.
143664|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143665|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143944|NCT01591616|O3|Outcome|Vital Signs (Systolic), 0 Minutes Pre-dose|
143622|NCT01592773|B1|Baseline|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.
Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
143623|NCT01592773|P1|Participant Flow|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.
Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
143624|NCT01592773|O1|Outcome|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.
Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
143625|NCT01592773|E1|Reported Event|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.
Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
143626|NCT01592760|B4|Baseline|Total|Total of all reporting groups
143627|NCT01592760|B3|Baseline|I-gel|"i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)
i-gel: i-gel placement for airway maintenance."
143628|NCT01592760|B2|Baseline|Air-Q SP|"air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)
air-Q SP: air-Q SP placement for airway maintenance."
143629|NCT01592760|B1|Baseline|Air-Q|"air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)
air-Q SP: air-Q SP placement for airway maintenance."
143630|NCT01592760|P3|Participant Flow|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143631|NCT01592760|P2|Participant Flow|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143632|NCT01592760|P1|Participant Flow|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143633|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143634|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143635|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143636|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143637|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143638|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143639|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143640|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143641|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143642|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143643|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143644|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143645|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143646|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
145210|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
143650|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143651|NCT01592760|O3|Outcome|I-gel|"i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)
i-gel: i-gel placement for airway maintenance."
143652|NCT01592760|O2|Outcome|Air-Q|"air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)
air-Q: air-Q placement for airway maintenance."
143653|NCT01592760|O1|Outcome|Air-Q SP|"air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)
air-Q SP: air-Q SP placement for airway maintenance."
143654|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143655|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143656|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143657|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143658|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143659|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143660|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143661|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143662|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143663|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
153584|NCT01549964|B5|Baseline|Total|Total of all reporting groups
143666|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143667|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143668|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143669|NCT01592760|E3|Reported Event|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
143670|NCT01592760|E2|Reported Event|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
143671|NCT01592760|E1|Reported Event|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
143672|NCT01592708|B3|Baseline|Total|Total of all reporting groups
143673|NCT01592708|B2|Baseline|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
143674|NCT01592708|B1|Baseline|Intervention Cohort|This arm was managed perioperatively with the protocol.
143675|NCT01592708|P2|Participant Flow|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
143676|NCT01592708|P1|Participant Flow|Intervention Cohort|Patients undergoing maxillary surgery using antiemetic anesthesia protocol
143677|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary
143678|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary
143679|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
143680|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
143681|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary
143682|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary.
143683|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
143684|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
143685|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
143686|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
143687|NCT01592708|E2|Reported Event|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
143688|NCT01592708|E1|Reported Event|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthesia protocol
143689|NCT01592695|B3|Baseline|Total|Total of all reporting groups
143690|NCT01592695|B2|Baseline|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.
Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
143722|NCT01592396|O1|Outcome|Tralokinumab 300 mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
143691|NCT01592695|B1|Baseline|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
143692|NCT01592695|P2|Participant Flow|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.
Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
143693|NCT01592695|P1|Participant Flow|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.
Tailored behavioral intervention: Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules treatment modules to address common issues associated with cigarette smoking based on individual need and preference. Individual treatment models address alcohol risk reduction, elevated depressive symptoms, and concerns about weight gain."
143735|NCT01592344|B2|Baseline|Control|Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
143945|NCT01591616|O2|Outcome|Vital Signs (Systolic), - 10 Minutes Pre-dose|
143694|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
143695|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
143696|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.
Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
143697|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
143698|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.
Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
143699|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
143700|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.
Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
143701|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
143723|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
143724|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
145211|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
143702|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.
Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
143703|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
143704|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.
Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
143705|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
143706|NCT01592695|O2|Outcome|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.
Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
143707|NCT01592695|O1|Outcome|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
143708|NCT01592695|E2|Reported Event|Enhanced Standard of Care Group|"Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.
Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."
143709|NCT01592695|E1|Reported Event|Tailored Intervention Group|"Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination."
143710|NCT01592435|B1|Baseline|Pred. & Invest.-All Study Participants|"Cedera AccuStitch Software is standard of care software currently used at sites.
Carestream DR LLI software is investigational software used for reconstruction"
143711|NCT01592435|P1|Participant Flow|Pred. & Invest.-All Study Participants|"Cedera AccuStitch Software is standard of care software currently used at sites.
Carestream DR LLI software is investigational software used for reconstruction."
143712|NCT01592435|O1|Outcome|Invest. - Carestream DR LLI Software|Carestream DR LLI software is investigational software used for reconstruction.
143713|NCT01592435|O1|Outcome|Predicate - Cedera AccuStitch Software|Cedera AccuStitch Software is standard of care software currently used at sites.
143714|NCT01592435|E2|Reported Event|Invest. - Carestream DR LLI Software|Carestream DR LLI software is investigational software used for reconstruction.
143715|NCT01592435|E1|Reported Event|Predicate - Cedera AccuStitch Software|Cedara Accustitch is the standard of care software currently used by sites.
143716|NCT01592396|B3|Baseline|Total|Total of all reporting groups
143717|NCT01592396|B2|Baseline|Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
143718|NCT01592396|B1|Baseline|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
143719|NCT01592396|P2|Participant Flow|Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
143720|NCT01592396|P1|Participant Flow|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
143721|NCT01592396|O1|Outcome|Tralokinumab 300mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
143725|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
143726|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
143727|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
143728|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
143729|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
143730|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
143731|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
143732|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
143733|NCT01592396|E1|Reported Event|Tralokinumab 300 mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
143734|NCT01592344|B3|Baseline|Total|Total of all reporting groups
143736|NCT01592344|B1|Baseline|Active Stimulation Treatment|Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
143737|NCT01592344|P2|Participant Flow|Control|Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
143738|NCT01592344|P1|Participant Flow|Active Stimulation Treatment|Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
143739|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.
StimRouter - Control: The stimulation program settings for this arm are as follows:
Stim Settings
Waveform: Symmetric or Asymmetric
Phase Duration: 200 µsec
Pulse Rate: 1 Hz
Intensity: 0 mA Time Settings
Constant Stim: On
Total Time: 6 hour"
143740|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.
StimRouter - active stimulation: The stimulation program settings for this arm are as follows:
Stim Settings
Waveform: Symmetric or Asymmetric
Phase Duration: 100-250 µsec
Pulse Rate: 50-100 Hz
Intensity: 0-30mA Time Settings
Constant Stim: On
Total Time: 6 hour"
143741|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.
StimRouter - Control: The stimulation program settings for this arm are as follows:
Stim Settings
Waveform: Symmetric or Asymmetric
Phase Duration: 200 µsec
Pulse Rate: 1 Hz
Intensity: 0 mA Time Settings
Constant Stim: On
Total Time: 6 hour"
143742|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.
StimRouter - active stimulation: The stimulation program settings for this arm are as follows:
Stim Settings
Waveform: Symmetric or Asymmetric
Phase Duration: 100-250 µsec
Pulse Rate: 50-100 Hz
Intensity: 0-30mA Time Settings
Constant Stim: On
Total Time: 6 hour"
143743|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.
StimRouter - Control: The stimulation program settings for this arm are as follows:
Stim Settings
Waveform: Symmetric or Asymmetric
Phase Duration: 200 µsec
Pulse Rate: 1 Hz
Intensity: 0 mA Time Settings
Constant Stim: On
Total Time: 6 hour"
143764|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143765|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143744|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.
StimRouter - active stimulation: The stimulation program settings for this arm are as follows:
Stim Settings
Waveform: Symmetric or Asymmetric
Phase Duration: 100-250 µsec
Pulse Rate: 50-100 Hz
Intensity: 0-30mA Time Settings
Constant Stim: On
Total Time: 6 hour"
143745|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.
StimRouter - Control: The stimulation program settings for this arm are as follows:
Stim Settings
Waveform: Symmetric or Asymmetric
Phase Duration: 200 µsec
Pulse Rate: 1 Hz
Intensity: 0 mA Time Settings
Constant Stim: On
Total Time: 6 hour"
143771|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143772|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143746|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.
StimRouter - active stimulation: The stimulation program settings for this arm are as follows:
Stim Settings
Waveform: Symmetric or Asymmetric
Phase Duration: 100-250 µsec
Pulse Rate: 50-100 Hz
Intensity: 0-30mA Time Settings
Constant Stim: On
Total Time: 6 hour"
143747|NCT01592344|E2|Reported Event|StimRouter Control|"The stimulation program settings for the control arm are as follows:
Stim Settings
Waveform: Symmetric or Asymmetric
Phase Duration: 200 µsec
Pulse Rate: 1 Hz
Intensity: 0 mA Time Settings
Constant Stim: On
Total Time: 6 hour"
143748|NCT01592344|E1|Reported Event|StimRouter Active Stimulation|"The stimulation program settings for the active stimulation arm are as follows:
Stim Settings
Waveform: Symmetric or Asymmetric
Phase Duration: 100-250 µsec
Pulse Rate: 50-100 Hz
Intensity: 0-30mA Time Settings
Constant Stim: On
Total Time: 6 hour"
143749|NCT01592292|B3|Baseline|Total|Total of all reporting groups
143750|NCT01592292|B2|Baseline|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143751|NCT01592292|B1|Baseline|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143752|NCT01592292|P4|Participant Flow|Other Anti-TNF Agent: Infliximab|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving infliximab as per physician’s discretion for RA treatment were observed for 12 months.
143753|NCT01592292|P3|Participant Flow|Other Anti-TNF Agent: Etanercept|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving etanercept as per physician’s discretion for RA treatment were observed for 12 months.
143754|NCT01592292|P2|Participant Flow|Other Anti-TNF Agent: Adalimumab|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving adalimumab as per physician’s discretion for RA treatment were observed for 12 months.
143755|NCT01592292|P1|Participant Flow|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143756|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143757|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143758|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143759|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143760|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143761|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143762|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143763|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143921|NCT01591616|O26|Outcome|Vital Signs (Systolic), 230 Minutes Post-dose|
143922|NCT01591616|O25|Outcome|Vital Signs (Systolic), 220 Minutes Post-dose|
143766|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143767|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143768|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143769|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143770|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143946|NCT01591616|O1|Outcome|Vital Signs (Systolic), - 20 Minutes Pre-dose|
143773|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143774|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143775|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143776|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143777|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143778|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143779|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143780|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143781|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143782|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143783|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143784|NCT01592292|E2|Reported Event|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
143785|NCT01592292|E1|Reported Event|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
143786|NCT01592071|B1|Baseline|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
143787|NCT01592071|P1|Participant Flow|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
143788|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
143836|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143789|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
143790|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
143791|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
143792|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
143793|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
143794|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
143795|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
143796|NCT01592071|E1|Reported Event|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
143797|NCT01592045|B3|Baseline|Total|Total of all reporting groups
143798|NCT01592045|B2|Baseline|Sequence 2|"NCI ch14.18 for two courses followed by UTC ch14.18 for three courses
ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days
ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.
Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.
Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:
If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).
If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
143799|NCT01592045|B1|Baseline|Sequence 1|"UTC ch14.18 for two courses followed by NCI ch14.18 for three courses
ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days
ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.
Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.
Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:
If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).
If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
143800|NCT01592045|P2|Participant Flow|Sequence 2|"NCI ch14.18 for two courses followed by UTC ch14.18 for three courses
ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days
ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.
Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.
Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:
If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).
If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
143801|NCT01592045|P1|Participant Flow|Sequence 1|"UTC ch14.18 for two courses followed by NCI ch14.18 for three courses
ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days
ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.
Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.
Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:
If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).
If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
143802|NCT01592045|O2|Outcome|NCI ch14.18|NCI Manufactured ch14.18
143803|NCT01592045|O1|Outcome|UTC ch14.18|United Therapeutics Manufactured ch14.18
143804|NCT01592045|O2|Outcome|NCI ch14.18|NCI Manufactured ch14.18
143805|NCT01592045|O1|Outcome|UTC ch14.18|United Therapeutics Manufactured ch14.18
143806|NCT01592045|E2|Reported Event|NCI ch14.18|NCI Manufactured ch14.18
143807|NCT01592045|E1|Reported Event|UTC ch14.18|United Therapeutics Manufactured ch14.18
143808|NCT01592006|B1|Baseline|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
143809|NCT01592006|P1|Participant Flow|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
143810|NCT01592006|O1|Outcome|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
143811|NCT01592006|O1|Outcome|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
143812|NCT01592006|E1|Reported Event|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
143947|NCT01591616|O27|Outcome|Vital Signs (Pulse Rate), 240 Minutes Post-dose|
143813|NCT01591954|B1|Baseline|Video Augmentation|"Qualitative assessment of the value of video-based navigation system
Video Augmentation: Assessment of value of video-based navigation system"
143814|NCT01591954|P1|Participant Flow|Video Augmentation|"Qualitative assessment of the value of video-based navigation system
Video Augmentation: Assessment of value of video-based navigation system"
143815|NCT01591954|O1|Outcome|Video Augmentation|"Qualitative assessment of the value of video-based navigation system
Video Augmentation: Assessment of value of video-based navigation system"
143816|NCT01591954|O1|Outcome|Video Augmentation|"Qualitative assessment of the value of video-based navigation system
Video Augmentation: Assessment of value of video-based navigation system"
143817|NCT01591954|E1|Reported Event|Video Augmentation|"Qualitative assessment of the value of video-based navigation system
Video Augmentation: Assessment of value of video-based navigation system"
143818|NCT01591863|B1|Baseline|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
143819|NCT01591863|P1|Participant Flow|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
143820|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
143821|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
143822|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
143823|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
143824|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
143825|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
143826|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
143827|NCT01591863|E1|Reported Event|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
143828|NCT01591837|B3|Baseline|Total|Total of all reporting groups
143829|NCT01591837|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143830|NCT01591837|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143831|NCT01591837|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143832|NCT01591837|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143833|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143834|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143835|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
145212|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
143837|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143838|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143839|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143840|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143841|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143842|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143843|NCT01591837|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143844|NCT01591837|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
143866|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
143845|NCT01591681|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
143846|NCT01591681|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
143847|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
143848|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
143849|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
143850|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
143851|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
143852|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
143853|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
143854|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
143855|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
143856|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
143857|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
143858|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
143859|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
143860|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
143861|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
143918|NCT01591616|O2|Outcome|Vital Signs (Diastolic), - 10 Minutes Pre-dose|
143919|NCT01591616|O1|Outcome|Vital Signs (Diastolic), - 20 Minutes Pre-dose|
143920|NCT01591616|O27|Outcome|Vital Signs (Systolic), 240 Minutes Post-dose|
143862|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
143863|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
143864|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
143865|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
143867|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
143948|NCT01591616|O26|Outcome|Vital Signs (Pulse Rate), 230 Minutes Post-dose|
143949|NCT01591616|O25|Outcome|Vital Signs (Pulse Rate), 220 Minutes Post-dose|
143868|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.
Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
143869|NCT01591681|E2|Reported Event|Standard of Care|On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
143870|NCT01591681|E1|Reported Event|Pump Suspension Algorithm|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.)
143871|NCT01591616|B1|Baseline|Oraqix for Tooth Extraction|lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
143872|NCT01591616|P1|Participant Flow|Oraqix for Tooth Extraction|lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
143873|NCT01591616|O4|Outcome|QTcB Interval, 4 Hour Post-dose|
143874|NCT01591616|O3|Outcome|QTcB Interval, 2 Hour Post-dose|
143875|NCT01591616|O2|Outcome|QTcB Interval, 1 Hour Post-dose|
143876|NCT01591616|O1|Outcome|QTcB Interval, Pre-dose|
143877|NCT01591616|O4|Outcome|QT Interval, 4 Hour Post-dose|
143878|NCT01591616|O3|Outcome|QT Interval, 2 Hour Post-dose|
143879|NCT01591616|O2|Outcome|QT Interval, 1 Hour Post-dose|
143880|NCT01591616|O1|Outcome|QT Interval, Pre-dose|
143881|NCT01591616|O4|Outcome|QRS Duration, 4 Hour Post-dose|
143882|NCT01591616|O3|Outcome|QRS Duration, 2 Hour Post-dose|
143883|NCT01591616|O2|Outcome|QRS Duration, 1 Hour Post-dose|
143884|NCT01591616|O1|Outcome|QRS Duration, Pre-dose|
143885|NCT01591616|O4|Outcome|PR Interval, 4 Hour Post-dose|
143886|NCT01591616|O3|Outcome|PR Interval, 2 Hour Post-dose|
143887|NCT01591616|O2|Outcome|PR Interval, 1 Hour Post-dose|
143888|NCT01591616|O1|Outcome|PR Interval, Pre-dose|
143889|NCT01591616|O4|Outcome|Ventricular Heart Rate, 4 Hour Post-dose|
143890|NCT01591616|O3|Outcome|Ventricular Heart Rate, 2 Hour Post-dose|
143891|NCT01591616|O2|Outcome|Ventricular Heart Rate, 1 Hour Post-dose|
143892|NCT01591616|O1|Outcome|Ventricular Heart Rate, Pre-dose|
143893|NCT01591616|O27|Outcome|Vital Signs (Diastolic), 240 Minutes Post-dose|
143894|NCT01591616|O26|Outcome|Vital Signs (Diastolic), 230 Minutes Post-dose|
143895|NCT01591616|O25|Outcome|Vital Signs (Diastolic), 220 Minutes Post-dose|
143896|NCT01591616|O24|Outcome|Vital Signs (Diastolic), 210 Minutes Post-dose|
143897|NCT01591616|O23|Outcome|Vital Signs (Diastolic), 200 Minutes Post-dose|
143898|NCT01591616|O22|Outcome|Vital Signs (Diastolic), 190 Minutes Post-dose|
143899|NCT01591616|O21|Outcome|Vital Signs (Diastolic), 180 Minutes Post-dose|
143900|NCT01591616|O20|Outcome|Vital Signs (Diastolic), 170 Minutes Post-dose|
143901|NCT01591616|O19|Outcome|Vital Signs (Diastolic), 160 Minutes Post-dose|
143902|NCT01591616|O18|Outcome|Vital Signs (Diastolic), 150 Minutes Post-dose|
143903|NCT01591616|O17|Outcome|Vital Signs (Diastolic), 140 Minutes Post-dose|
143904|NCT01591616|O16|Outcome|Vital Signs Diastolic(), 130 Minutes Post-dose|
143905|NCT01591616|O15|Outcome|Vital Signs (Diastolic), 120 Minutes Post-dose|
143906|NCT01591616|O14|Outcome|Vital Signs (Diastolic), 110 Minutes Post-dose|
143907|NCT01591616|O13|Outcome|Vital Signs (Diastolic), 100 Minutes Post-dose|
143908|NCT01591616|O12|Outcome|Vital Signs (Diastolic), 90 Minutes Post-dose|
143909|NCT01591616|O11|Outcome|Vital Signs (Diastolic) 80 Minutes Post-dose|
143910|NCT01591616|O10|Outcome|Vital Signs (Diastolic), 70 Minutes Post-dose|
143911|NCT01591616|O9|Outcome|Vital Signs Diastolic(), 60 Minutes Post-dose|
143912|NCT01591616|O8|Outcome|Vital Signs (Diastolic), 50 Minutes Post-dose|
143913|NCT01591616|O7|Outcome|Vital Signs (Diastolic), 40 Minutes Post-dose|
143914|NCT01591616|O6|Outcome|Vital Signs (Diastolic), 30 Minutes Post-dose|
143915|NCT01591616|O5|Outcome|Vital Signs (Diastolic), 20 Minutes Post-dose|
143916|NCT01591616|O4|Outcome|Vital Signs (Diastolic), 10 Minutes Post-dose|
143917|NCT01591616|O3|Outcome|Vital Signs (Diastolic), 0 Minutes Pre-dose|
143923|NCT01591616|O24|Outcome|Vital Signs (Systolic), 210 Minutes Post-dose|
143924|NCT01591616|O23|Outcome|Vital Signs (Systolic), 200 Minutes Post-dose|
143925|NCT01591616|O22|Outcome|Vital Signs (Systolic), 190 Minutes Post-dose|
143926|NCT01591616|O21|Outcome|Vital Signs (Systolic), 180 Minutes Post-dose|
143927|NCT01591616|O20|Outcome|Vital Signs (Systolic), 170 Minutes Post-dose|
143928|NCT01591616|O19|Outcome|Vital Signs (Systolic), 160 Minutes Post-dose|
143929|NCT01591616|O18|Outcome|Vital Signs (Systolic), 150 Minutes Post-dose|
143930|NCT01591616|O17|Outcome|Vital Signs (Systolic), 140 Minutes Post-dose|
143931|NCT01591616|O16|Outcome|Vital Signs (Systolic), 130 Minutes Post-dose|
143932|NCT01591616|O15|Outcome|Vital Signs (Systolic), 120 Minutes Post-dose|
143933|NCT01591616|O14|Outcome|Vital Signs (Systolic), 110 Minutes Post-dose|
143934|NCT01591616|O13|Outcome|Vital Signs (Systolic), 100 Minutes Post-dose|
143935|NCT01591616|O12|Outcome|Vital Signs (Systolic), 90 Minutes Post-dose|
143936|NCT01591616|O11|Outcome|Vital Signs (Systolic) 80 Minutes Post-dose|
143937|NCT01591616|O10|Outcome|Vital Signs (Systolic), 70 Minutes Post-dose|
143938|NCT01591616|O9|Outcome|Vital Signs (Systolic), 60 Minutes Post-dose|
143939|NCT01591616|O8|Outcome|Vital Signs (Systolic), 50 Minutes Post-dose|
154081|NCT01546883|B1|Baseline|Dabigatran|Dabigatran
143950|NCT01591616|O24|Outcome|Vital Signs (Pulse Rate), 210 Minutes Post-dose|
143951|NCT01591616|O23|Outcome|Vital Signs (Pulse Rate), 200 Minutes Post-dose|
143952|NCT01591616|O22|Outcome|Vital Signs (Pulse Rate), 190 Minutes Post-dose|
143953|NCT01591616|O21|Outcome|Vital Signs (Pulse Rate), 180 Minutes Post-dose|
143954|NCT01591616|O20|Outcome|Vital Signs (Pulse Rate), 170 Minutes Post-dose|
143955|NCT01591616|O19|Outcome|Vital Signs (Pulse Rate), 160 Minutes Post-dose|
143956|NCT01591616|O18|Outcome|Vital Signs (Pulse Rate), 150 Minutes Post-dose|
143957|NCT01591616|O17|Outcome|Vital Signs (Pulse Rate), 140 Minutes Post-dose|
143958|NCT01591616|O16|Outcome|Vital Signs (Pulse Rate), 130 Minutes Post-dose|
143959|NCT01591616|O15|Outcome|Vital Signs (Pulse Rate), 120 Minutes Post-dose|
143960|NCT01591616|O14|Outcome|Vital Signs (Pulse Rate), 110 Minutes Post-dose|
143961|NCT01591616|O13|Outcome|Vital Signs (Pulse Rate), 100 Minutes Post-dose|
143962|NCT01591616|O12|Outcome|Vital Signs (Pulse Rate), 90 Minutes Post-dose|
143963|NCT01591616|O11|Outcome|Vital Signs (Pulse Rate), 80 Minutes Post-dose|
143964|NCT01591616|O10|Outcome|Vital Signs (Pulse Rate), 70 Minutes Post-dose|
143965|NCT01591616|O9|Outcome|Vital Signs (Pulse Rate), 60 Minutes Post-dose|
143966|NCT01591616|O8|Outcome|Vital Signs (Pulse Rate), 50 Minutes Post-dose|
143967|NCT01591616|O7|Outcome|Vital Signs (Pulse Rate), 40 Minutes Post-dose|
143968|NCT01591616|O6|Outcome|Vital Signs (Pulse Rate), 30 Minutes Post-dose|
143969|NCT01591616|O5|Outcome|Vital Signs (Pulse Rate), 20 Minutes Post-dose|
143970|NCT01591616|O4|Outcome|Vital Signs (Pulse Rate), 10 Minutes Post-dose|
143971|NCT01591616|O3|Outcome|Vital Signs (Pulse Rate), 0 Minutes Pre-dose|
143972|NCT01591616|O2|Outcome|Vital Signs (Pulse Rate), - 10 Minutes Pre-dose|
143973|NCT01591616|O1|Outcome|Vital Signs (Pulse Rate), - 20 Minutes Pre-dose|
143974|NCT01591616|O4|Outcome|O-toluidine Tmax|
143975|NCT01591616|O3|Outcome|2,6-xylidine Tmax|
143976|NCT01591616|O2|Outcome|Prilocaine Tmax|
143977|NCT01591616|O1|Outcome|Lidocaine Tmax|
143978|NCT01591616|O27|Outcome|% MetHemoglobin (MetHb) Time Point 240 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143979|NCT01591616|O26|Outcome|% MetHemoglobin (MetHb) Time Point 230 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143980|NCT01591616|O25|Outcome|% MetHemoglobin (MetHb) Time Point 220 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143981|NCT01591616|O24|Outcome|% MetHemoglobin (MetHb) Time Point 210 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143982|NCT01591616|O23|Outcome|% MetHemoglobin (MetHb) Time Point 200 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143983|NCT01591616|O22|Outcome|% MetHemoglobin (MetHb) Time Point 190 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143984|NCT01591616|O21|Outcome|% MetHemoglobin (MetHb) Time Point 180 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143985|NCT01591616|O20|Outcome|% MetHemoglobin (MetHb) Time Point 170 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143986|NCT01591616|O19|Outcome|% MetHemoglobin (MetHb) Time Point 160 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143987|NCT01591616|O18|Outcome|% MetHemoglobin (MetHb) Time Point 150 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143988|NCT01591616|O17|Outcome|% MetHemoglobin (MetHb) Time Point 140 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143989|NCT01591616|O16|Outcome|% MetHemoglobin (MetHb) Time Point 130 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143990|NCT01591616|O15|Outcome|% MetHemoglobin (MetHb) Time Point 120 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143991|NCT01591616|O14|Outcome|% MetHemoglobin (MetHb) Time Point 110 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143992|NCT01591616|O13|Outcome|% MetHemoglobin (MetHb) Time Point 100 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143993|NCT01591616|O12|Outcome|% MetHemoglobin (MetHb) Time Point 90 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143994|NCT01591616|O11|Outcome|% MetHemoglobin (MetHb) Time Point 80 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143995|NCT01591616|O10|Outcome|% MetHemoglobin (MetHb) Time Point 70 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143996|NCT01591616|O9|Outcome|% MetHemoglobin (MetHb) Time Point 60 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143997|NCT01591616|O8|Outcome|% MetHemoglobin (MetHb) Time Point 50 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143998|NCT01591616|O7|Outcome|% MetHemoglobin (MetHb) Time Point 40 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
143999|NCT01591616|O6|Outcome|% MetHemoglobin (MetHb) Time Point 30 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
144000|NCT01591616|O5|Outcome|% MetHemoglobin (MetHb) Time Point 20 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
144001|NCT01591616|O4|Outcome|% MetHemoglobin (MetHb) Time Point 10 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
144002|NCT01591616|O3|Outcome|% MetHemoglobin (MetHb) Time Point 0 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
144003|NCT01591616|O2|Outcome|% MetHemoglobin (MetHb) Time Point -10 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
144004|NCT01591616|O1|Outcome|% MetHemoglobin (MetHb) Time Point -20 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
144005|NCT01591616|O4|Outcome|O-toluidine Cmax|
144006|NCT01591616|O3|Outcome|2,6-xylidine Cmax|
144007|NCT01591616|O2|Outcome|Prilocaine Cmax|
144008|NCT01591616|O1|Outcome|Lidocaine Cmax|
144009|NCT01591616|E1|Reported Event|Adverse Events|
144010|NCT01591499|B3|Baseline|Total|Total of all reporting groups
144011|NCT01591499|B2|Baseline|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision or Purevision crossover to Biofinity)
144012|NCT01591499|B1|Baseline|Biofinity/Air Optix Aqua Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix or Air Optix crossover to Biofinity)
144013|NCT01591499|P4|Participant Flow|Purevision Then Biofinity|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).
First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
144014|NCT01591499|P3|Participant Flow|Biofinity Then Purevision|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).
First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
144015|NCT01591499|P2|Participant Flow|Air Optix Then Biofinity|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).
First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
144016|NCT01591499|P1|Participant Flow|Biofinity Then Air Optix|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).
First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
144017|NCT01591499|O3|Outcome|Evaluated At Least One Lens|Population of patients having evaluated at least one lens pair
144018|NCT01591499|O2|Outcome|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision) (Purevision crossover to Biofinity
144019|NCT01591499|O1|Outcome|Biofinity/Air Optix Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix) (Air Optix crossover to Biofinity)
144020|NCT01591499|O3|Outcome|Evaluated At Least One Lens|Population of patients having evaluated at least one lens pair.
144021|NCT01591499|O2|Outcome|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision) (Purevision crossover to Biofinity
144022|NCT01591499|O1|Outcome|Biofinity/Air Optix Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix) (Air Optix crossover to Biofinity)
144023|NCT01591499|O3|Outcome|Purevision Multifocal|Clinical performance by lens (Purevision Multifocal)
144024|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Clinical performance by lens (Air Optix Aqua Multifocal)
144025|NCT01591499|O1|Outcome|Biofinity Multifocal|Clinical performance by lens (Biofinity Multifocal) tested at V3 or V5
144026|NCT01591499|O3|Outcome|Purevision Multifocal|Geometric performance by lens (Purevision Multifocal)
144027|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Geometric performance by lens (Air Optix Aqua Multifocal)
144028|NCT01591499|O1|Outcome|Biofinity Multifocal|Geometric performance by lens (Biofinity Multifocal) tested at V3 or V5
144029|NCT01591499|O3|Outcome|Purevision Multifocal|Geometric performance by lens (Purevision Multifocal)
144030|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Geometric performance by lens (Air Optix Aqua Multifocal)
144031|NCT01591499|O1|Outcome|Biofinity Multifocal|Geometric performance by lens (Biofinity Multifocal) tested at V3 or V5
144032|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
144033|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
144034|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
144035|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
144036|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
144037|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
144038|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
144039|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
144040|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
144041|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
144042|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
144043|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
144044|NCT01591499|O3|Outcome|Purevision Multifocal|Comfort performance by lens (Purevision Multifocal)
144045|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Comfort performance by lens (Air Optix Aqua Multifocal)
144046|NCT01591499|O1|Outcome|Biofinity Multifocal|Comfort performance by lens (Biofinity Multifocal) tested at V3 or V5
144047|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
144048|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
144049|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
144050|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
144051|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
144052|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
144053|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
144054|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
144055|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
144056|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
144057|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
144058|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
144059|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
144060|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
144061|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
144062|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
144063|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
144064|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
144065|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
144066|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
144067|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
144068|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
144069|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
144070|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
144071|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
144072|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
144073|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
144074|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
144075|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
144076|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal)
144077|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
144078|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
144079|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
144080|NCT01591499|E1|Reported Event|Overall Study Population|Population of patients having evaluated at least one lens
144081|NCT01591460|B1|Baseline|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144090|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144192|NCT01591317|P2|Participant Flow|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
144082|NCT01591460|P1|Participant Flow|Total Population|Treatment-naive participants with chronic hepatitis C (CHC) received treatment with peginterferon alfa-2a (PEG-IFN) 180 micrograms (mcg) subcutaneous (SC) once weekly, weight-based ribavirin (RBV) 1000 to 1200 milligrams (mg) orally (PO) daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a less than (<) 1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144083|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144084|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144085|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144086|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144087|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144121|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144088|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144089|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144183|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144184|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144185|NCT01591382|E2|Reported Event|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144091|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144092|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144093|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
144094|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144095|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144096|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144097|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144098|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144171|NCT01591382|B2|Baseline|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144397|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
144099|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
144100|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144101|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144102|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144103|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144104|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144105|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
144106|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144107|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144108|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144109|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144172|NCT01591382|B1|Baseline|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144173|NCT01591382|P2|Participant Flow|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144174|NCT01591382|P1|Participant Flow|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144110|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144111|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
144186|NCT01591382|E1|Reported Event|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144187|NCT01591317|B4|Baseline|Total|Total of all reporting groups
144419|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
144112|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144113|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144114|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144115|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144116|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144117|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
144118|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144119|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144120|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144175|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144122|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144123|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
144124|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144125|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144126|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144127|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144128|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144129|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
144130|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144131|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144132|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144176|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144133|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144134|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144306|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144135|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
144136|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144137|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144138|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144139|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144140|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144141|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
144142|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144143|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144177|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144398|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
144144|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144145|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144188|NCT01591317|B3|Baseline|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
144146|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144147|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
144148|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144149|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144150|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144151|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144152|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144153|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
144154|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
144178|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144399|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
144155|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
144189|NCT01591317|B2|Baseline|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
144190|NCT01591317|B1|Baseline|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
144191|NCT01591317|P3|Participant Flow|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
144420|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
144156|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
144157|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
144158|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
144159|NCT01591460|E2|Reported Event|Noncirrhotics (Safety)|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants without liver cirrhosis, including those with transition to cirrhosis, were grouped separately in the safety analysis.
144160|NCT01591460|E1|Reported Event|Cirrhotics (Safety)|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants with liver cirrhosis were grouped separately in the safety analysis.
144161|NCT01591408|B3|Baseline|Total|Total of all reporting groups
144162|NCT01591408|B2|Baseline|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.
EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
144163|NCT01591408|B1|Baseline|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms
EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
144164|NCT01591408|P2|Participant Flow|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.
EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
144165|NCT01591408|P1|Participant Flow|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms
EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
144166|NCT01591408|O2|Outcome|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.
EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
144167|NCT01591408|O1|Outcome|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms
EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
144168|NCT01591408|E2|Reported Event|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.
EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
144169|NCT01591408|E1|Reported Event|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms
EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
144170|NCT01591382|B3|Baseline|Total|Total of all reporting groups
144179|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144180|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144181|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144182|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
144193|NCT01591317|P1|Participant Flow|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
144194|NCT01591317|O3|Outcome|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
144195|NCT01591317|O2|Outcome|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
144196|NCT01591317|O1|Outcome|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
144197|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
144198|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
144199|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
144200|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
144201|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
144202|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
144203|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
144204|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
144205|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
144206|NCT01591317|O3|Outcome|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
144207|NCT01591317|O2|Outcome|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
144208|NCT01591317|O1|Outcome|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
144209|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
144210|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
144211|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
144212|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
144213|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
144214|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
144215|NCT01591317|E3|Reported Event|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
144216|NCT01591317|E2|Reported Event|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
144217|NCT01591317|E1|Reported Event|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
144218|NCT01591044|B4|Baseline|Total|Total of all reporting groups
144219|NCT01591044|B3|Baseline|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid
R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
144220|NCT01591044|B2|Baseline|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
144221|NCT01591044|B1|Baseline|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid
R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
144222|NCT01591044|P3|Participant Flow|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid
R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
144223|NCT01591044|P2|Participant Flow|Placebo|Placebo: 1 puff bid or 2 puffs bid
144224|NCT01591044|P1|Participant Flow|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid
R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
144225|NCT01591044|O3|Outcome|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid
R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
144226|NCT01591044|O2|Outcome|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
144227|NCT01591044|O1|Outcome|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid
R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
144228|NCT01591044|E3|Reported Event|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid
R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
144229|NCT01591044|E2|Reported Event|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
144230|NCT01591044|E1|Reported Event|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid
R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
144231|NCT01591018|B3|Baseline|Total|Total of all reporting groups
144460|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
144232|NCT01591018|B2|Baseline|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144233|NCT01591018|B1|Baseline|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144234|NCT01591018|P2|Participant Flow|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144235|NCT01591018|P1|Participant Flow|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144236|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144237|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144238|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144307|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144239|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144240|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144241|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144242|NCT01591018|E2|Reported Event|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144243|NCT01591018|E1|Reported Event|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
144244|NCT01591005|B5|Baseline|Total|Total of all reporting groups
144245|NCT01591005|B4|Baseline|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis
carotid stenting: percutaneous transluminal angioplasty and stenting"
144246|NCT01591005|B3|Baseline|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid stenting: percutaneous transluminal angioplasty and stenting"
144247|NCT01591005|B2|Baseline|CEA Without Sonolysis|"endarterectomy without sonolysis
endarterectomy: carotid endarterectomy"
144248|NCT01591005|B1|Baseline|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
endarterectomy: carotid endarterectomy"
144249|NCT01591005|P4|Participant Flow|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis
carotid stenting: percutaneous transluminal angioplasty and stenting"
144250|NCT01591005|P3|Participant Flow|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid stenting: percutaneous transluminal angioplasty and stenting"
144251|NCT01591005|P2|Participant Flow|CEA Without Sonolysis|"endarterectomy without sonolysis
endarterectomy: carotid endarterectomy"
144252|NCT01591005|P1|Participant Flow|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
endarterectomy: carotid endarterectomy"
144253|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis
carotid stenting: percutaneous transluminal angioplasty and stenting"
144254|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid stenting: percutaneous transluminal angioplasty and stenting"
144255|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis
endarterectomy: carotid endarterectomy"
144256|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
endarterectomy: carotid endarterectomy"
144257|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis
carotid stenting: percutaneous transluminal angioplasty and stenting"
144258|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid stenting: percutaneous transluminal angioplasty and stenting"
144259|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis
endarterectomy: carotid endarterectomy"
144260|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
endarterectomy: carotid endarterectomy"
144261|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis
carotid stenting: percutaneous transluminal angioplasty and stenting"
144262|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid stenting: percutaneous transluminal angioplasty and stenting"
144263|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis
endarterectomy: carotid endarterectomy"
144264|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
endarterectomy: carotid endarterectomy"
144265|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis
carotid stenting: percutaneous transluminal angioplasty and stenting"
144266|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid stenting: percutaneous transluminal angioplasty and stenting"
144267|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis
endarterectomy: carotid endarterectomy"
144268|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
endarterectomy: carotid endarterectomy"
144269|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis
carotid stenting: percutaneous transluminal angioplasty and stenting"
144270|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid stenting: percutaneous transluminal angioplasty and stenting"
144271|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis
endarterectomy: carotid endarterectomy"
144272|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
endarterectomy: carotid endarterectomy"
144273|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis
carotid stenting: percutaneous transluminal angioplasty and stenting"
144274|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid stenting: percutaneous transluminal angioplasty and stenting"
144275|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis
endarterectomy: carotid endarterectomy"
144276|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
endarterectomy: carotid endarterectomy"
144277|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis
carotid stenting: percutaneous transluminal angioplasty and stenting"
144278|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid stenting: percutaneous transluminal angioplasty and stenting"
144279|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis
endarterectomy: carotid endarterectomy"
144280|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
endarterectomy: carotid endarterectomy"
144281|NCT01591005|E4|Reported Event|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis
carotid stenting: percutaneous transluminal angioplasty and stenting"
144282|NCT01591005|E3|Reported Event|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid stenting: percutaneous transluminal angioplasty and stenting"
144283|NCT01591005|E2|Reported Event|CEA Without Sonolysis|"endarterectomy without sonolysis
endarterectomy: carotid endarterectomy"
144284|NCT01591005|E1|Reported Event|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
endarterectomy: carotid endarterectomy"
144285|NCT01590979|B3|Baseline|Total|Total of all reporting groups
144286|NCT01590979|B2|Baseline|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
Placebo: two times a day, 12 hour intervals"
144287|NCT01590979|B1|Baseline|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.
Ranolazine: 1000mg, two times a day, 12 hour intervals"
144288|NCT01590979|P2|Participant Flow|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
Placebo: two times a day, 12 hour intervals"
144289|NCT01590979|P1|Participant Flow|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.
Ranolazine: 1000mg, two times a day, 12 hour intervals"
144290|NCT01590979|O2|Outcome|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
Placebo: two times a day, 12 hour intervals"
144291|NCT01590979|O1|Outcome|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.
Ranolazine: 1000mg, two times a day, 12 hour intervals"
144461|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
144292|NCT01590979|E2|Reported Event|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
Placebo: two times a day, 12 hour intervals"
144293|NCT01590979|E1|Reported Event|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.
Ranolazine: 1000mg, two times a day, 12 hour intervals"
144294|NCT01590888|B4|Baseline|Total|Total of all reporting groups
144295|NCT01590888|B3|Baseline|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144296|NCT01590888|B2|Baseline|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144297|NCT01590888|B1|Baseline|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144298|NCT01590888|P3|Participant Flow|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144299|NCT01590888|P2|Participant Flow|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144300|NCT01590888|P1|Participant Flow|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144301|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144302|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144303|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144304|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144305|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144308|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144309|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144310|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144311|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144312|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144313|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144314|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144315|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144316|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144317|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144318|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144319|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144320|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144321|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144322|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144323|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144324|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144325|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144326|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144327|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144328|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144329|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144330|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144331|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144332|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144333|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144334|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144335|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144336|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144337|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144338|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144339|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144340|NCT01590888|E3|Reported Event|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
144341|NCT01590888|E2|Reported Event|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
144342|NCT01590888|E1|Reported Event|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
144343|NCT01590875|B3|Baseline|Total|Total of all reporting groups
144344|NCT01590875|B2|Baseline|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
144393|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
144394|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
144345|NCT01590875|B1|Baseline|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.
Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
144346|NCT01590875|P2|Participant Flow|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
144347|NCT01590875|P1|Participant Flow|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.
Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
144348|NCT01590875|O2|Outcome|Observation Arm|10 patients were be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.
144349|NCT01590875|O1|Outcome|Adenosine Arm|10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given to the 7 patients without pulmonary vein reconnection after initial dose.
144350|NCT01590875|O2|Outcome|Observation Arm|10patients were randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.
144351|NCT01590875|O1|Outcome|Adenosine Arm|10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given to the 7 patients that did not demonstrate pulmonary vein reconnection after initial dose.
144352|NCT01590875|O2|Outcome|Observation Arm|"10 patients were randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.
Of these 10 patients, none demonstrated pulmonary vein reconnection during the 10 minute period of observation."
144353|NCT01590875|O1|Outcome|Adenosine Arm|"10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given only if no reconnection after initial dose.
Of these 10 patients, 3 patients were noted to have pulmonary vein reconnection post initial dose of adenosine in at least one pulmonary vein. No patient demonstrated pulmonary vein reconnection with second dose of adenosine."
144354|NCT01590875|O2|Outcome|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
144355|NCT01590875|O1|Outcome|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.
Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
144356|NCT01590875|E2|Reported Event|Observation Arm|10 patients were be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.
144357|NCT01590875|E1|Reported Event|Adenosine Arm|10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given to the 7 patients without reconnection after initial dose.
144358|NCT01590810|B6|Baseline|Total|Total of all reporting groups
144359|NCT01590810|B5|Baseline|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
144360|NCT01590810|B4|Baseline|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
144361|NCT01590810|B3|Baseline|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
144395|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
144396|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
144362|NCT01590810|B2|Baseline|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
144363|NCT01590810|B1|Baseline|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
144364|NCT01590810|P5|Participant Flow|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
144414|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
144415|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
144416|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
144417|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
144365|NCT01590810|P4|Participant Flow|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
144366|NCT01590810|P3|Participant Flow|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
144367|NCT01590810|P2|Participant Flow|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
144368|NCT01590810|P1|Participant Flow|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
144369|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
144370|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
144371|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
144372|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
144373|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
144374|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
144375|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
144376|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
144377|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
144378|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
144379|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
144380|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
144381|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
144382|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
144383|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
144384|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
144385|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
144386|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
144387|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
144388|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
144389|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
144390|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
144391|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
144392|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
144400|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
144401|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
144402|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
144403|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
144404|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
144405|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
144406|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
144407|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
144408|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
144409|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
144410|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
144411|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
144412|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
144413|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
144418|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
144421|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
144422|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
144423|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
144424|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
144425|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
144426|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
144427|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
144428|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
144429|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
144430|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
144431|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
144432|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
144433|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
144434|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
144435|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
144436|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
144437|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
144438|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
144439|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
144440|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
144441|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
144442|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
144443|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
144444|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
144445|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
144446|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
144447|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
144448|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
144449|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
144450|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
144451|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
144452|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
144453|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
144454|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
144455|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
144456|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
144457|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
144458|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
144459|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
144463|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
144464|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
144465|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
144466|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
144467|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
144468|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
144469|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
144470|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
144471|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
144472|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
144473|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
144474|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
144475|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
144476|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
144477|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
144478|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
144479|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
144480|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
144481|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
144482|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
144483|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
144484|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
144485|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
144486|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
144487|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
144488|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
144489|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
144490|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
144491|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
144492|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
144493|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
144494|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
144495|NCT01590810|O5|Outcome|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
144496|NCT01590810|O4|Outcome|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
144497|NCT01590810|O3|Outcome|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
144498|NCT01590810|O2|Outcome|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
144499|NCT01590810|O1|Outcome|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
144541|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144500|NCT01590810|O5|Outcome|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
144501|NCT01590810|O4|Outcome|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
144502|NCT01590810|O3|Outcome|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
144503|NCT01590810|O2|Outcome|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
144633|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144504|NCT01590810|O1|Outcome|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
144505|NCT01590810|E5|Reported Event|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
144506|NCT01590810|E4|Reported Event|Panel D – MK-8150 50 to 200 mg|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
144507|NCT01590810|E3|Reported Event|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
144508|NCT01590810|E2|Reported Event|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
144509|NCT01590810|E1|Reported Event|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
144510|NCT01590797|B3|Baseline|Total|Total of all reporting groups
144511|NCT01590797|B2|Baseline|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144512|NCT01590797|B1|Baseline|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144513|NCT01590797|P2|Participant Flow|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144514|NCT01590797|P1|Participant Flow|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144515|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144516|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144517|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144518|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144519|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144520|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144634|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144521|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144522|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144523|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144524|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144525|NCT01590797|E2|Reported Event|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144526|NCT01590797|E1|Reported Event|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
144527|NCT01590771|B3|Baseline|Total|Total of all reporting groups
144528|NCT01590771|B2|Baseline|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144529|NCT01590771|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144530|NCT01590771|P2|Participant Flow|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144531|NCT01590771|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144532|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144533|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144534|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144535|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144536|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144537|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144538|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144539|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144540|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144542|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144543|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144544|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144545|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144546|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144547|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144548|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144549|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144550|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144551|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144864|NCT01588548|E5|Reported Event|AZD1208 700mg|Once daily continuous dosing schedule.
144552|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144553|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144554|NCT01590771|E2|Reported Event|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144555|NCT01590771|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
144556|NCT01590758|B3|Baseline|Total|Total of all reporting groups
144557|NCT01590758|B2|Baseline|Topical Placebo Control|"Topical placebo cream: 14 days of treatment
Standard wound care: 28-day trial period"
144558|NCT01590758|B1|Baseline|Topical Pexiganan Cream 0.8%|"Topical pexiganan cream 0.8%: 14 days of treatment
Standard wound care: 28-day trial period"
144559|NCT01590758|P2|Participant Flow|Topical Placebo Control|"Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)
Standard wound care: 28-day trial period"
144560|NCT01590758|P1|Participant Flow|Topical Pexiganan Cream 0.8%|"Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period)
Standard wound care: 28-day trial period"
144561|NCT01590758|O2|Outcome|Topical Placebo Control|Topical placebo cream: 14 days of treatment
144562|NCT01590758|O1|Outcome|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
144563|NCT01590758|O2|Outcome|Topical Placebo Control|Topical placebo cream: 14 days of treatment
144564|NCT01590758|O1|Outcome|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
144565|NCT01590758|O2|Outcome|Topical Placebo Control|Topical placebo cream: 14 days of treatment
144566|NCT01590758|O1|Outcome|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
144567|NCT01590758|E2|Reported Event|Topical Placebo Control|Topical placebo cream: 14 days of treatment
144568|NCT01590758|E1|Reported Event|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
144569|NCT01590563|B1|Baseline|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
144570|NCT01590563|P1|Participant Flow|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
144571|NCT01590563|O1|Outcome|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
144572|NCT01590563|O1|Outcome|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
144573|NCT01590563|O1|Outcome|Investigated Device Group|Group inserted the investigated device - the IUB SCu300A
144574|NCT01590563|E1|Reported Event|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
144575|NCT01590550|B1|Baseline|Observational|All patients receiving acute HD during the study period
144576|NCT01590550|P1|Participant Flow|Observational|All patients receiving acute HD during the study period
144577|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
144578|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period
144579|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
144580|NCT01590550|E1|Reported Event|Observational|All patients receiving acute HD during the study period
144581|NCT01590264|B1|Baseline|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)
Stimulation Settings:
DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000
TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
144621|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144582|NCT01590264|P1|Participant Flow|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)
Stimulation Settings:
DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000
TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
144583|NCT01590264|O1|Outcome|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)
Stimulation Settings:
DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000
TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
144584|NCT01590264|O1|Outcome|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)
Stimulation Settings:
DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000
TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
144635|NCT01589978|E1|Reported Event|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144636|NCT01589822|B4|Baseline|Total|Total of all reporting groups
144865|NCT01588548|E4|Reported Event|AZD1208 540mg|Once daily continuous dosing schedule.
144585|NCT01590264|E1|Reported Event|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)
Stimulation Settings:
DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000
TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
144586|NCT01590238|B1|Baseline|Treatment With PRFM|"Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.
PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
144587|NCT01590238|P1|Participant Flow|Treatment With PRFM|"Subjects treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.
PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
144588|NCT01590238|O1|Outcome|Treatment With PRFM|Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured (6 months after initial treatment) and compared to hair density index measured prior to treatment for each subject.
144589|NCT01590238|E1|Reported Event|Treatment With PRFM|"Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.
PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
144590|NCT01590212|B4|Baseline|Total|Total of all reporting groups
144591|NCT01590212|B3|Baseline|Care as Usual (CAU)|Participants received care in line with local guidelines.
144592|NCT01590212|B2|Baseline|Chill-out in Pregnancy (CHiP) + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
144593|NCT01590212|B1|Baseline|Mellow Bumps (MB) + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers’ understanding of neonates’ capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks’ gestation.
144594|NCT01590212|P3|Participant Flow|Care as Usual|"Care-as-usual comprises routine antenatal care provided by the NHS in line with local guidelines.
Services provided as part of an individividual woman's care plan. If indicated, a pre-birth case conference is held at 28-32 weeks."
144595|NCT01590212|P2|Participant Flow|Chill-out in Pregnancy + Care as Usual|"Chill-out in Pregnancy is a targeted intervention aimed at pregnant women with additional health and social care needs.
It is a stress-reduction programme which includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship elements.
Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant."
144596|NCT01590212|P1|Participant Flow|Mellow Bumps + Care as Usual|"Mellow Bumps is a targeted intervention aimed at pregnant women with additional health and social care needs.
Underpinned by attachment theory, there is a focus on:
Improving maternal wellbeing by reducing stress and anxiety Increasing expectant mother's understandings of neonates' capacity for social interaction Emphasising the importance of early interaction to enhance brain development and attachment.
Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant."
144597|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
144622|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144598|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
144599|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
144600|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
144601|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
144637|NCT01589822|B3|Baseline|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative"
144638|NCT01589822|B2|Baseline|Standard of Care|Standard surgical technique for GI anastomosis.
144866|NCT01588548|E3|Reported Event|AZD1208 360mg|Once daily continuous dosing schedule.
154272|NCT01546142|B3|Baseline|Total|Total of all reporting groups
144602|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
144603|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
144604|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
144605|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
144606|NCT01590212|O3|Outcome|Care as Usual|All participants received care in line with local guidelines.
144607|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
144608|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
144609|NCT01590212|E3|Reported Event|Care as Usual|Participants received care in line with local guidelines
144610|NCT01590212|E2|Reported Event|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
144611|NCT01590212|E1|Reported Event|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
144612|NCT01589978|B1|Baseline|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144613|NCT01589978|P1|Participant Flow|PROMUS Element Overall Population|"Subjects who receive the PROMUS Element everolimus-eluting coronary stent.
Subgroups within the Overall Population Group:
PLATINUM-Like Patients N=776 (at time of Primary endpoint)
Defined as: all patients without acute MI, graft stenting, CTO, ISR, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate or severe calcification by visual estimate in target lesion or target vessel proximal to target lesion, three-vessel stenting, cardiogenic shock, left main disease, or acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or patient on dialysis). For PLATINUM-like patients, lesion length and RVD should meet one of two criteria: 1) lesion length ≤28 mm and diameter ≥2.25 mm and <2.5 mm, or 2) lesion length ≤24 mm and diameter ≥2.5 mm and ≤4.25 mm.
Long Lesion Patients N=340 Defined as: patients treated with at least one 32mm or 38mm (excluding patients only treated with 2.25 mm diameter and 32 mm length WH stent size) study stent."
144614|NCT01589978|O1|Outcome|PROMUS Element Overall Population|Subjects who receive the PROMUS Element everolimus-eluting coronary stent.
144615|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144616|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144617|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144618|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144619|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144620|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144623|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144624|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144625|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144626|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144627|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144628|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144629|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144630|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144631|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144632|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
144639|NCT01589822|B1|Baseline|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative"
144640|NCT01589822|P3|Participant Flow|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative"
144641|NCT01589822|P2|Participant Flow|Standard of Care|Standard surgical technique for GI anastomosis.
144642|NCT01589822|P1|Participant Flow|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative"
144643|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
144644|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
144645|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
144646|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
144647|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
144648|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
144649|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
144650|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
144651|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
144652|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
144653|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (IIT)
144654|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative (IIT)"
144655|NCT01589822|E3|Reported Event|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
144656|NCT01589822|E2|Reported Event|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
144657|NCT01589822|E1|Reported Event|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
144658|NCT01589653|B3|Baseline|Total|Total of all reporting groups
144659|NCT01589653|B2|Baseline|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144660|NCT01589653|B1|Baseline|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144661|NCT01589653|P2|Participant Flow|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144662|NCT01589653|P1|Participant Flow|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144845|NCT01588548|B6|Baseline|AZD1208 800mg|Once daily continuous dosing schedule.
144846|NCT01588548|B5|Baseline|AZD1208 700mg|Once daily continuous dosing schedule.
144663|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144664|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144665|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144666|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144667|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144668|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144669|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144867|NCT01588548|E2|Reported Event|AZD1208 240mg|Once daily continuous dosing schedule.
144868|NCT01588548|E1|Reported Event|AZD1208 120mg|Once daily continuous dosing schedule.
144670|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144671|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144672|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144673|NCT01589653|E2|Reported Event|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144674|NCT01589653|E1|Reported Event|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
144675|NCT01589601|B3|Baseline|Total|Total of all reporting groups
144676|NCT01589601|B2|Baseline|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
144677|NCT01589601|B1|Baseline|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
144678|NCT01589601|P2|Participant Flow|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
144679|NCT01589601|P1|Participant Flow|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
144680|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
144681|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
144682|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
144788|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144869|NCT01588496|B4|Baseline|Total|Total of all reporting groups
144683|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
144684|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
144685|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
144686|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
144687|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
144688|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
144689|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
144746|NCT01589484|P1|Participant Flow|Shockwave Lithotripsy (SWL)|All patients were submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients were submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
144747|NCT01589484|O1|Outcome|SWL Complications|Shock wave lithotripsy complications
144690|NCT01589601|O2|Outcome|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
144691|NCT01589601|O1|Outcome|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
144692|NCT01589601|E2|Reported Event|Usual Heart Failure Care|Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
144693|NCT01589601|E1|Reported Event|Usual Care + Palliative Care|"Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention."
144694|NCT01589510|B1|Baseline|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
144695|NCT01589510|P1|Participant Flow|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
144696|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
144697|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
144698|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
144699|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
144700|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
144701|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
144702|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
144703|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
144704|NCT01589510|E1|Reported Event|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
144705|NCT01589497|B5|Baseline|Total|Total of all reporting groups
144706|NCT01589497|B4|Baseline|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
144707|NCT01589497|B3|Baseline|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
144708|NCT01589497|B2|Baseline|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
144709|NCT01589497|B1|Baseline|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
144710|NCT01589497|P4|Participant Flow|RZE-RZE|"Participants were administered only RZE from Day 1 through Day 14. Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily."
144748|NCT01589484|O1|Outcome|Primary Endoint|Shock wave lithotripsy outcome
144749|NCT01589484|E1|Reported Event|Shockwave Lithotripsy (SWL)|All patients will be submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
144786|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
145213|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
144711|NCT01589497|P3|Participant Flow|RHZE-RMZE|"Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.
Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily.
Moxifloxacin: one 400 mg tablet orally once a day."
144789|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144870|NCT01588496|B3|Baseline|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
144712|NCT01589497|P2|Participant Flow|RHZE-RZE|"Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.
Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once"
144713|NCT01589497|P1|Participant Flow|RHZE-RHZE|"Participants were administered RHZE from Day 1 to Day 14. Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.
Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily."
144714|NCT01589497|O1|Outcome|Overall|Qualified samples from overall participants
144715|NCT01589497|O2|Outcome|Decontaminated Processing Method|The decontaminated sputum processing method
144716|NCT01589497|O1|Outcome|Standard Processing Method|The standard sputum processing method
144717|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
144718|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
144719|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
144720|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
144721|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
144722|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
144723|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
144724|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
144725|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
144726|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
144727|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
144728|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
144729|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
144730|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
144731|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
144732|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
144733|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
144734|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
144735|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
144736|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
144737|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
144738|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
144739|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
144740|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
144741|NCT01589497|E4|Reported Event|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
144742|NCT01589497|E3|Reported Event|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
144743|NCT01589497|E2|Reported Event|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
144744|NCT01589497|E1|Reported Event|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
144745|NCT01589484|B1|Baseline|Shockwave Lithotripsy (SWL)|One hundred patients fulfilled the inclusion and exclusion criteria and were enrolled in this study. Mean age and BMI were 47.1 years and 28.0 Kg/m2, respectively. Half of patients had their stone localized in the right kidney. Mean stone size was 9.1mm and mean stone density was 795 HU.
144832|NCT01588561|B1|Baseline|All Study Participants|All study participants. All participants were randomized to receive all interventions, so all participants are combined into one Arm/Group.
144847|NCT01588548|B4|Baseline|AZD1208 540mg|Once daily continuous dosing schedule.
144750|NCT01589445|B1|Baseline|Single Group Study With Two Interventions|"This was double blind, single group and within subjects designed study with two interventions.We screened 130 patients, selected 77 subjects who received drug Code 001, then gone through one month wash out period, then received Code 002.For PPARγ genotyping blood samples were collected from patients. There were found two groups-Pro12Pro and Pro12Ala. Baseline evaluation included detailed medical history,socioeconomic status, physical examination, and laboratory investigations for biomedical variables,psychosocial factors according to Patient Health Questionnaire (PHQ-9) and WHO-5 questionnaires.We decoded blinded drug after analyzing the results and knew that pioglitazone (30 mg once daily) was coded as 001 and metformin (850 mg once daily) as code 002.
For statistical analysis we compare Pio vs Met, Pro12Pro vs Pro12Ala, met responder vs non responder."
154327|NCT01545700|O24|Outcome|Dexamethasone 8 mg 8-24 Hours-24 Hours|
144751|NCT01589445|P1|Participant Flow|Single Group Study With Two Drugs- Pioglitazone and Metformin|"Group 001-Pioglitazone 30 mg tablet once daily Group 002-Metformin 850 mg tablet once daily
The single group study with a wash out period of one month with metformin 850 mg tablet once daily.
77 patients started with pioglitazone(7 drop out)and after one month wash out period 70 patients started with metformin (9 drop out).
48 patients for the 1st 3 months of pioglitazone and 32 patients for the 2nd 3 months of metformin responded to the drugs respectively according to the response rate[The treatment target was set to reduce at least ≥10% FBG or ≥1% HbA1c in the patients considering as the responder group]."
144752|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
144753|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
144754|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
144755|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
144756|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
144757|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
144758|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
144759|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
144760|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
144761|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30mg once daily for 3 months.
144762|NCT01589445|O2|Outcome|Metformin (002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
144763|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
144764|NCT01589445|E2|Reported Event|Metformin (002 Group)|"After wash out period 70 patients started with metformin (850mg/day) for further 3 months. Adverse events were assessed non-systematically on patients' complain and also systematically in case of hypertension, weight gain, common depression (PHQ-9 method) and creatinine increase.
On basis of systemic data review and patient complain one patient was found with hypertension and another one was with increased creatinine level at the end of the metformin treatment and these events were assumed as serious adverse events as they were at health risk and withdrawn from the trial for intervention by hospital physician though they didn't need for hospitalization.
One patient complained for mild diarrhea in the first month of the metformin treatment, the patient needed necessary treatment according to doctor's advice for one day, Five patients complained for abdominal discomfort in the 1st month and antacid was provided. Six patients were assumed suffering from common depression."
144765|NCT01589445|E1|Reported Event|Pioglitazone (001 Group)|"77 patients received the drug pioglitazone (30mg/day) for 3 months. Adverse events were assessed non-systematically on patients' complain generally and also systematically in case of hypertension, weight gain, common depression [Patient Health Questionnaire (PHQ-9) method] and creatinine increase.
No serious adverse event was found during pioglitazone trial.
In case of other adverse event, one patient complained for peripheral edema which disappeared (without medicine) within 2 days at the 2nd month of the treatment, Four patients gained weight within 10% of their initial weight after 3 months of the treatment and two patients complained for abdominal discomfort in the 1st month and normal treatment with antacid was provided to them."
144766|NCT01589237|B5|Baseline|Total|Total of all reporting groups
144767|NCT01589237|B4|Baseline|Pradigastat (LCQ908) Regimen- From Study A2212|"Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
144768|NCT01589237|B3|Baseline|40 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
144769|NCT01589237|B2|Baseline|20 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
144785|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144833|NCT01588561|P2|Participant Flow|Nicotine First, Then Placebo|Intravenous Nicotine (1.5 mg/70 kg) first, then Placebo
144770|NCT01589237|B1|Baseline|Placebo of Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
144859|NCT01588548|O4|Outcome|AZD1208 540mg|Once daily continuous dosing schedule.
144860|NCT01588548|O3|Outcome|AZD1208 360mg|Once daily continuous dosing schedule.
144771|NCT01589237|P4|Participant Flow|Pradigastat (LCQ908) Regimen- From Study A2212|"Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
144772|NCT01589237|P3|Participant Flow|40 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
144773|NCT01589237|P2|Participant Flow|20 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
144774|NCT01589237|P1|Participant Flow|Placebo of Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
144775|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144776|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144777|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144778|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144779|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144780|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144781|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144782|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144783|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144784|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144834|NCT01588561|P1|Participant Flow|Placebo First, Then Nicotine|Placebo first, then Intravenous Nicotine (1.5 mg/70 kg)
144835|NCT01588561|O2|Outcome|Placebo|Saline infusion
144836|NCT01588561|O1|Outcome|Nicotine|Intravenous Nicotine (1.5 mg/70 kg)
144787|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144861|NCT01588548|O2|Outcome|AZD1208 240mg|Once daily continuous dosing schedule.
144862|NCT01588548|O1|Outcome|AZD1208 120mg|Once daily continuous dosing schedule.
144863|NCT01588548|E6|Reported Event|AZD1208 800mg|Once daily continuous dosing schedule.
144790|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144791|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144792|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144793|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144794|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144795|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144796|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144797|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144798|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144799|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144800|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144801|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144802|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144803|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144804|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144805|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144837|NCT01588561|O1|Outcome|Nicotine|Intravenous Nicotine (1.5 mg/70 kg)
144838|NCT01588561|O1|Outcome|Nicotine|Intravenous Nicotine (1.5 mg/70 kg)
144839|NCT01588561|O1|Outcome|Nicotine|Intravenous Nicotine (1.5 mg/70 kg)
144806|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144807|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144808|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144809|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144810|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144811|NCT01589237|E8|Reported Event|Part B-40 mg Pradigastat (LCQ908)|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
144812|NCT01589237|E7|Reported Event|Part B- Pradigastat (LCQ908) Regimen- From Study A2212|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
144813|NCT01589237|E6|Reported Event|Part B-20mg Pradigastat (LCQ908) Regimen|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
144814|NCT01589237|E5|Reported Event|Part B-placebo of Pradigastat (LCQ908) Regimen|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
144815|NCT01589237|E4|Reported Event|Part A: Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144816|NCT01589237|E3|Reported Event|Part A-40mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144817|NCT01589237|E2|Reported Event|Part A-20mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144818|NCT01589237|E1|Reported Event|Part A-placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
144819|NCT01588951|B4|Baseline|Total|Total of all reporting groups
144820|NCT01588951|B3|Baseline|Arm 3|"LSC present, randomized to allogeneic transplant
Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
144821|NCT01588951|B2|Baseline|Arm 2|"LSC present, randomized to cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
144822|NCT01588951|B1|Baseline|Arm 1|"Without LSC, standard cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
144823|NCT01588951|P3|Participant Flow|Arm 3|"LSC present, randomized to allogeneic transplant
Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
144824|NCT01588951|P2|Participant Flow|Arm 2|"LSC present, randomized to cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
144825|NCT01588951|P1|Participant Flow|Arm 1|"Without LSC, standard cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
144826|NCT01588951|O3|Outcome|Arm 3|"LSC present, randomized to allogeneic transplant
Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
144827|NCT01588951|O2|Outcome|Arm 2|"LSC present, randomized to cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
144828|NCT01588951|O1|Outcome|Arm 1|"Without LSC, standard cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
144829|NCT01588951|E3|Reported Event|Arm 3|"LSC present, randomized to allogeneic transplant
Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
144830|NCT01588951|E2|Reported Event|Arm 2|"LSC present, randomized to cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
144831|NCT01588951|E1|Reported Event|Arm 1|"Without LSC, standard cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
144848|NCT01588548|B3|Baseline|AZD1208 360mg|Once daily continuous dosing schedule.
144849|NCT01588548|B2|Baseline|AZD1208 240mg|Once daily continuous dosing schedule.
144850|NCT01588548|B1|Baseline|AZD1208 120mg|Once daily continuous dosing schedule.
144851|NCT01588548|P6|Participant Flow|AZD1208 800mg|Once daily continuous dosing schedule.
144852|NCT01588548|P5|Participant Flow|AZD1208 700mg|Once daily continuous dosing schedule.
144853|NCT01588548|P4|Participant Flow|AZD1208 540mg|Once daily continuous dosing schedule.
144854|NCT01588548|P3|Participant Flow|AZD1208 360mg|Once daily continuous dosing schedule.
144855|NCT01588548|P2|Participant Flow|AZD1208 240mg|Once daily continuous dosing schedule.
144856|NCT01588548|P1|Participant Flow|AZD1208 120mg|Once daily continuous dosing schedule.
144857|NCT01588548|O6|Outcome|AZD1208 800mg|Once daily continuous dosing schedule.
144858|NCT01588548|O5|Outcome|AZD1208 700mg|Once daily continuous dosing schedule.
144871|NCT01588496|B2|Baseline|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
144872|NCT01588496|B1|Baseline|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
144873|NCT01588496|P3|Participant Flow|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
144874|NCT01588496|P2|Participant Flow|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
144875|NCT01588496|P1|Participant Flow|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
144876|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
144877|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
144878|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
144879|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
144880|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
144881|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
144882|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
144883|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
144884|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
144885|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
144886|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
144887|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
144888|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
144889|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
144890|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
144891|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
144892|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
144893|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
144894|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
144895|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
144896|NCT01588496|E3|Reported Event|Part B: DB Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
144897|NCT01588496|E2|Reported Event|Part B: DB Placebo|Participants received double-blind (DB) placebo subcutaneously once a month for 12 weeks.
144898|NCT01588496|E1|Reported Event|Part A: OL Evolocumab|Participants received open-label (OL) evolocumab 420 mg subcutaneously once a month for 12 weeks.
144899|NCT01588444|B3|Baseline|Total|Total of all reporting groups
144900|NCT01588444|B2|Baseline|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
cortical FDBA: cortical mineralized freeze-dried bone allograft"
144901|NCT01588444|B1|Baseline|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)
Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
144902|NCT01588444|P2|Participant Flow|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
cortical FDBA: cortical mineralized freeze-dried bone allograft"
144903|NCT01588444|P1|Participant Flow|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)
Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
144904|NCT01588444|O2|Outcome|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
cortical FDBA: cortical mineralized freeze-dried bone allograft"
144905|NCT01588444|O1|Outcome|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)
Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
144906|NCT01588444|E2|Reported Event|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
cortical FDBA: cortical mineralized freeze-dried bone allograft"
144907|NCT01588444|E1|Reported Event|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)
Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
144908|NCT01588418|B1|Baseline|PET With Exenatide vs Placebo Injection|"All subjects will receive the same intervention with Exenatide and placebo. Exenatide or placebo will be administered in random order, (i.e. first or second before OGTT-PET study).
In the first study IGT male subjects will be randomized to exenatide or placebo injection before OGTT-PET study. In the second study the same subjects will receive placebo or exenatide respectively before OGTT-PET study. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject."
144909|NCT01588418|P2|Participant Flow|OGTT-PET: Placebo First, Then Exenatide|In the first study subjects received placebo injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received exenatide injection (5ug) before OGTT-PET
144910|NCT01588418|P1|Participant Flow|OGTT-PET: Exenatide First Then Placebo|In the first study subjects received exenatide 5ug injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received placebo injection before OGTT-PET
144963|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144911|NCT01588418|O1|Outcome|Effect of Exenatide or Placebo on CMRglu|Brain glucose metabolism (CMRglu) during OGTT measured by PET w/ or w/out Exenatide injection
144912|NCT01588418|E1|Reported Event|PET With Exenatide or Placebo Injection|This is a crossover study where all subjects received the same intervention with Exenatide and placebo, acutely in random order, (i.e. first or second before OGTT-PET study).
144913|NCT01588405|B1|Baseline|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144914|NCT01588405|P1|Participant Flow|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144915|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144916|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144917|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144918|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144919|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144920|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144921|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
144922|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
144923|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
144924|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
144925|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
144926|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
144927|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
144928|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
144929|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
144930|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144931|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144932|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144933|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144934|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
154328|NCT01545700|O23|Outcome|Dexamethasone 8 mg 8-24 Hours-8 Hours|
144935|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144936|NCT01588405|E1|Reported Event|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
144937|NCT01588353|B4|Baseline|Total|Total of all reporting groups
144938|NCT01588353|B3|Baseline|AK160 0.58 mg Step3|"The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3.
This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2.
Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
144939|NCT01588353|B2|Baseline|AK160 0.58 mg Step 2|"This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3.
Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
144940|NCT01588353|B1|Baseline|AK160 0.58 mg Step 1|"This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2.
And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3.
Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
144941|NCT01588353|P3|Participant Flow|AK160 0.58 mg Step3|"The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3.
This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2.
Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
144942|NCT01588353|P2|Participant Flow|AK160 0.58 mg Step 2|"This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3.
Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
144943|NCT01588353|P1|Participant Flow|AK160 0.58 mg Step1|"This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2.
And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3.
Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
144944|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
144945|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
144946|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
144947|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
145214|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
144948|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
144949|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
144950|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
144951|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
144952|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
144953|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
144954|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
144955|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
144956|NCT01588353|O1|Outcome|AK160 0.58 mg Step 1-2|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
144957|NCT01588353|E1|Reported Event|AK160 0.58 mg Step 1-3|Collagenase Clostridium Histolyticum: AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
144958|NCT01588158|B3|Baseline|Total|Total of all reporting groups
144959|NCT01588158|B2|Baseline|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144960|NCT01588158|B1|Baseline|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
144961|NCT01588158|P2|Participant Flow|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144962|NCT01588158|P1|Participant Flow|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
154329|NCT01545700|O22|Outcome|Dexamethasone 8 mg 8-24 Hours-baseline|
144964|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
144965|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144966|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
144967|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144968|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
144969|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144970|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
144971|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144972|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
144973|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144974|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
144975|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144976|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
144977|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144978|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
144979|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144980|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
144981|NCT01588158|E2|Reported Event|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen
Vicodin: Vicodin 5/325 mg"
144982|NCT01588158|E1|Reported Event|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin
Acetaminophen: 325 mg"
144983|NCT01588106|B3|Baseline|Total|Total of all reporting groups
144984|NCT01588106|B2|Baseline|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
144985|NCT01588106|B1|Baseline|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
144986|NCT01588106|P2|Participant Flow|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
144987|NCT01588106|P1|Participant Flow|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
144988|NCT01588106|O2|Outcome|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
144989|NCT01588106|O1|Outcome|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
144990|NCT01588106|E2|Reported Event|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
144991|NCT01588106|E1|Reported Event|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
144992|NCT01587989|B3|Baseline|Total|Total of all reporting groups
144993|NCT01587989|B2|Baseline|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
144994|NCT01587989|B1|Baseline|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145035|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
144995|NCT01587989|P3|Participant Flow|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
144996|NCT01587989|P2|Participant Flow|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
144997|NCT01587989|P1|Participant Flow|All Participants|Participants received TCZ 8 milligrams per kilogram (mg/kg), intravenously (IV), every 4 weeks, from Weeks 1-12. Participants also received MTX 15 milligrams per week (mg/week) to 25 mg/week at a stable dose, orally (PO) as tablets, once per week, from Weeks 1-12. Participants also received folic acid, greater than or equal to (≥) 5 mg/week, PO, from Weeks 1-12. Participants also received non-sterioidal anti-inflammatory drugs (NSAIDs) and oral corticosteroids (less than or equal to [≤] 10 milligrams per day [mg/day] prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-12. At Week 12 participants who had achieved a good or moderate European League Against Rheumatism (EULAR) response were randomized to receive TCZ plus (+) continued MTX treatment or TCZ + placebo. Participants without a good or moderate EULAR response were excluded from the study and treated according to the standard of care of the treatment site.
144998|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
144999|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145000|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145059|NCT01587885|P1|Participant Flow|Omeprazole 20mg+Sodium Bicarbonate 1100mg Then Omeprazole 20mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
145060|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
145215|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
145001|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145002|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145003|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145004|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145005|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145006|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145007|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145008|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145009|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145010|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145011|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145012|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145013|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145014|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145015|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145016|NCT01587989|E2|Reported Event|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145017|NCT01587989|E1|Reported Event|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
145018|NCT01587963|B3|Baseline|Total|Total of all reporting groups
145019|NCT01587963|B2|Baseline|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline
Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
145020|NCT01587963|B1|Baseline|Ascorbic Acid|"Ascorbic Acid
Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
145021|NCT01587963|P2|Participant Flow|Placebo|"Ringers Lactate or Normal Saline
Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
145022|NCT01587963|P1|Participant Flow|Ascorbic Acid|"Ascorbic Acid
Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
145023|NCT01587963|O2|Outcome|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline
Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
145024|NCT01587963|O1|Outcome|Ascorbic Acid|"Ascorbic Acid
Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
145025|NCT01587963|E2|Reported Event|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline
Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
145026|NCT01587963|E1|Reported Event|Ascorbic Acid|"Ascorbic Acid
Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
145027|NCT01587950|B1|Baseline|Overall|All randomized participants received all study treatments during this cross over study design.
145061|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
145062|NCT01587885|O1|Outcome|All Treated Participants|
145028|NCT01587950|P1|Participant Flow|Overall|There were six study treatment regimens- 5% Potassium nitrate (KNO3) 250μl applied to an individual tooth once for 2, 5 or 10 min; 2.5% KNO3 (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Three reference treatment regimens were sterile water (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Each participant received 9 treatment regimens over three treatment visits. Three individual teeth were treated at each treatment visit. Each treatment visit was one day in length. A washout of 4 days was given after each treatment visit. Study duration for each participant during this efficacy analysis phase was approximately 5 weeks
145029|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
145030|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
145031|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
145032|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
145033|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
145034|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
145239|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg (PT003)|18/9.6 μg
145240|NCT01587079|O1|Outcome|GP MDI 18 μg (PT001)|18 μg
145036|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
145037|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
145038|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
145039|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
145040|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
145041|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
145042|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
145043|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
145044|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
145045|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth sensitive tooth once for 2 minutes during each treatment period.
145046|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
145047|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
145048|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
145049|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
145050|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
145051|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
145052|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
145053|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
145054|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
145055|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
145056|NCT01587950|E1|Reported Event|Overall|All participants received all study treatments during this cross over study design.
145057|NCT01587885|B1|Baseline|All Participants|All participants who were randomized and received study drug.
145058|NCT01587885|P2|Participant Flow|Omeprazole 20mg Then Omeprazole 20mg+Sodium Bicarbonate 1100mg|Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
145063|NCT01587885|O1|Outcome|All Treated Participants|
145065|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
145066|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
145067|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
145068|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
145069|NCT01587885|E2|Reported Event|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
145070|NCT01587885|E1|Reported Event|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
145071|NCT01587651|B4|Baseline|Total|Total of all reporting groups
145072|NCT01587651|B3|Baseline|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD
Ticagrelor Maintenance Dose : one 90mg film coated tablet"
145073|NCT01587651|B2|Baseline|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
145074|NCT01587651|B1|Baseline|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
145075|NCT01587651|P3|Participant Flow|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD
Ticagrelor Maintenance Dose : one 90mg film coated tablet"
145076|NCT01587651|P2|Participant Flow|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
145241|NCT01587079|E8|Reported Event|Spiriva|18 μg
145077|NCT01587651|P1|Participant Flow|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
145078|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
145079|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
145080|NCT01587651|O2|Outcome|Ticagrelor|
145081|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
145082|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
145083|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
145084|NCT01587651|O2|Outcome|Ticagrelor|
145085|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
145086|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
145087|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
145088|NCT01587651|O2|Outcome|Ticagrelor|
145089|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
145090|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
145091|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
145092|NCT01587651|O2|Outcome|Ticagrelor|
145093|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
145094|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
145095|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
145096|NCT01587651|O2|Outcome|Ticagrelor|
145097|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
145098|NCT01587651|O2|Outcome|Ticagrelor|
145099|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
145100|NCT01587651|E3|Reported Event|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD
Ticagrelor Maintenance Dose : one 90mg film coated tablet"
145101|NCT01587651|E2|Reported Event|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
145102|NCT01587651|E1|Reported Event|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet
Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
145103|NCT01587118|B1|Baseline|Antidepressant Plus Asenapine|"adjunctive asenapine
Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
145104|NCT01587118|P1|Participant Flow|Antidepressant Plus Asenapine|"adjunctive asenapine
Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
145105|NCT01587118|O1|Outcome|Antidepressant Plus Asenapine|"adjunctive asenapine
Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
145106|NCT01587118|O1|Outcome|Antidepressant Plus Asenapine|"adjunctive asenapine
Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
145107|NCT01587118|E1|Reported Event|Antidepressant Plus Asenapine|"adjunctive asenapine
Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
145108|NCT01587105|B3|Baseline|Total|Total of all reporting groups
145109|NCT01587105|B2|Baseline|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
145110|NCT01587105|B1|Baseline|Control|Usual Care Group
145111|NCT01587105|P2|Participant Flow|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
145112|NCT01587105|P1|Participant Flow|Control|Usual Care Group
145113|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
145114|NCT01587105|O1|Outcome|Control|Usual Care Group
145242|NCT01587079|E7|Reported Event|FF MDI 9.6 μg (PT005)|9.6 μg
145243|NCT01587079|E6|Reported Event|GFF MDI 1.2/9.6 μg (PT003)|1.2/9.6 μg
145244|NCT01587079|E5|Reported Event|GFF MDI 2.4/9.6 μg (PT003)|2.4/9.6 μg
145115|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
145116|NCT01587105|O1|Outcome|Control|Usual Care Group
145117|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
145118|NCT01587105|O1|Outcome|Control|Usual Care Group
145119|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
145120|NCT01587105|O1|Outcome|Control|Usual Care Group
145121|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
145122|NCT01587105|O1|Outcome|Control|Usual Care Group
145123|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
145124|NCT01587105|O1|Outcome|Control|Usual Care Group
145125|NCT01587105|E2|Reported Event|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
145126|NCT01587105|E1|Reported Event|Control|Usual Care Group
145127|NCT01587079|B1|Baseline|All Subjects Screened|
145128|NCT01587079|P1|Participant Flow|All Subjects|
145129|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
145130|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
145131|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
145132|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
145133|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg BID|4.6/9.6 μg BID
145134|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
145135|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
145136|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
145137|NCT01587079|O8|Outcome|Spiriva18 μg QD|18 μg QD
145138|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
145139|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
145140|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
145141|NCT01587079|O4|Outcome|GFF MDI 4.6/9.6 μg BID|4.6/9.6 μg BID
145142|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
145143|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
145144|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
145145|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
145146|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
145147|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
145216|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
145217|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
145218|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
145219|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
145220|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
145221|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
145222|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
145223|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
145224|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
145225|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
145226|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
145227|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
145228|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
145229|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
145230|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
145231|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
145232|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
145233|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
145234|NCT01587079|O7|Outcome|FF MDI 9.6 μg|9.6 μg
145235|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg (PT003)|1.2/9.6 μg
145236|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg (PT003)|2.4/9.6 μg
145237|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
145238|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg|9/9.6 μg
145245|NCT01587079|E4|Reported Event|GFF MDI 4.6/9.6 μg (PT003)|4.6/9.6 μg
145246|NCT01587079|E3|Reported Event|GFF MDI 9/9.6 μg (PT003)|9/9.6 μg
145247|NCT01587079|E2|Reported Event|GFF MDI 18/9.6 μg (PT003)|18/9.6 μg
145248|NCT01587079|E1|Reported Event|GP MDI 18 μg (PT001)|18 μg
145249|NCT01587027|B3|Baseline|Total|Total of all reporting groups
145250|NCT01587027|B2|Baseline|Sequence B|"Treatment 2, Treatment 1, Treatment 3
Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally
Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
145251|NCT01587027|B1|Baseline|Sequence A|"Treatment 1, Treatment 2, Treatment 3
Treatment 1 : Aminophylline dosage form-tablet dosage-500mg
Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
145252|NCT01587027|P2|Participant Flow|Sequence B|"Treatment 2, Treatment 1, Treatment 3
Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally
Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
145253|NCT01587027|P1|Participant Flow|Sequence A|"Treatment 1, Treatment 2, Treatment 3
Treatment 1 : Aminophylline dosage form-tablet dosage-500mg
Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
145254|NCT01587027|O2|Outcome|Sequence B|"Treatment 2, Treatment 1, Treatment 3
Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally
Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
145255|NCT01587027|O1|Outcome|Sequence A|"Treatment 1, Treatment 2, Treatment 3
Treatment 1 : Aminophylline dosage form-tablet dosage-500mg
Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
145256|NCT01587027|E2|Reported Event|Arm B|Methazolamide (1 Day) Washout (1 Day) Aminophylline (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)
145257|NCT01587027|E1|Reported Event|Arm A|Aminophylline (1 Day) Washout (1 Day) Methazolamide (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)
145258|NCT01587014|B1|Baseline|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
145259|NCT01587014|P1|Participant Flow|Prima-Temp Monitoring Patch|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
145260|NCT01587014|O1|Outcome|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
145261|NCT01587014|O1|Outcome|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
145262|NCT01587014|E1|Reported Event|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
145263|NCT01587001|B3|Baseline|Total|Total of all reporting groups
145264|NCT01587001|B2|Baseline|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
145265|NCT01587001|B1|Baseline|Oral N-acetyl-cysteine|"oral NAC 900mg three times daily for 8 weeks
N-acetyl-cysteine: 900mg three times daily for 8 weeks"
145266|NCT01587001|P2|Participant Flow|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
145267|NCT01587001|P1|Participant Flow|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
145268|NCT01587001|O2|Outcome|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
145269|NCT01587001|O1|Outcome|Oral N-acetyl-cysteine|"oral NAC 900mg three times daily for 8 weeks
N-acetyl-cysteine: 900mg three times daily for 8 weeks"
145270|NCT01587001|O2|Outcome|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
145271|NCT01587001|O1|Outcome|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
145272|NCT01587001|E2|Reported Event|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
145273|NCT01587001|E1|Reported Event|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
145274|NCT01586975|B4|Baseline|Total|Total of all reporting groups
145275|NCT01586975|B3|Baseline|Aspiring >300 mg|Aspirin >300 mg QD
145276|NCT01586975|B2|Baseline|Aspirin 81 mg|Aspirin 81 mg QD
145277|NCT01586975|B1|Baseline|Clopidogrel 75 mg|Clopidogrel 75 mg QD
145278|NCT01586975|P3|Participant Flow|Aspirin > 300 mg|Aspiring > 300 mg QD
145279|NCT01586975|P2|Participant Flow|Aspirin 81 mg|Aspirin 81 mg QD
145280|NCT01586975|P1|Participant Flow|Clopidogrel 75 mg|Clopidogrel 75 mg QD
145281|NCT01586975|O3|Outcome|Aspirin > 300 mg|open-label Aspirin
145282|NCT01586975|O2|Outcome|Aspirin 81 mg|open label Aspirin
145283|NCT01586975|O1|Outcome|Clopidogrel 75 mg|Clopidogrel 75 mg QD
145284|NCT01586975|E3|Reported Event|Aspirin >300 mg|Aspirin >300 mg QD
145285|NCT01586975|E2|Reported Event|Aspirin 81 mg|Aspirin 81 mg QD
145286|NCT01586975|E1|Reported Event|Clopidogrel 75 mg|Clopidogrel 75 mg QD
145287|NCT01586962|B1|Baseline|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
145288|NCT01586962|P1|Participant Flow|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
145289|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
145290|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
145291|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
145292|NCT01586962|E1|Reported Event|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
145293|NCT01586897|B3|Baseline|Total|Total of all reporting groups
145294|NCT01586897|B2|Baseline|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care
While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs."
145345|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
154330|NCT01545700|O21|Outcome|Dexamethasone 4 mg 8-24 Hours-24 Hours|
145295|NCT01586897|B1|Baseline|Use of Medication Metronome|"Medication Metronome: PCPs allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid.
While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs."
145296|NCT01586897|P2|Participant Flow|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care
26 Primary Care Physicians randomized to Usual Care, with 1606 patients analyzed."
145297|NCT01586897|P1|Participant Flow|Use of Medication Metronome|"Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid.
26 Primary Care Physicians were randomized to Use of Medication Metronome with 2049 patients analyzed."
145298|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care"
145299|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
145300|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care"
145301|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
145302|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care"
145303|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
145304|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care"
145305|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
145306|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care"
145307|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
145308|NCT01586897|E4|Reported Event|Usual Care - Patients|"Patients of PCPs allocated to Usual Care were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication."
145309|NCT01586897|E3|Reported Event|Use of Medication Metronome - Patients|"Patients of PCPs allocated to the Use of Medication Metronome were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication."
145310|NCT01586897|E2|Reported Event|Usual Care - PCPs|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.
Usual Care"
145311|NCT01586897|E1|Reported Event|Use of Medication Metronome - PCPs|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipidemia.
145312|NCT01586806|B4|Baseline|Total|Total of all reporting groups
145313|NCT01586806|B3|Baseline|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
145314|NCT01586806|B2|Baseline|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
145315|NCT01586806|B1|Baseline|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
145316|NCT01586806|P3|Participant Flow|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
145346|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145839|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening"
145317|NCT01586806|P2|Participant Flow|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
145318|NCT01586806|P1|Participant Flow|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
145319|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
145320|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
145321|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
145322|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
145323|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
145324|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
145325|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
145326|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
145327|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
145328|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
145329|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
145330|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
145331|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
145332|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
145333|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
145334|NCT01586806|E3|Reported Event|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
145378|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145335|NCT01586806|E2|Reported Event|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
145336|NCT01586806|E1|Reported Event|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
145337|NCT01586364|B1|Baseline|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145338|NCT01586364|P1|Participant Flow|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145339|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145340|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145341|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145342|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145343|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145344|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
154331|NCT01545700|O20|Outcome|Dexamethasone 4 mg 8-24 Hours-8 Hours|
145347|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145348|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145349|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145350|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145351|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145352|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145353|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145354|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145355|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145356|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145357|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145358|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145359|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145360|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145361|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145362|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145363|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145364|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145365|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145366|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145367|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145368|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145369|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145370|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145371|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145372|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145373|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145374|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145375|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145376|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145377|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
146198|NCT01583374|B4|Baseline|Total|Total of all reporting groups
145379|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145380|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145381|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145382|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145383|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145384|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145385|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145386|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145387|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145388|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145389|NCT01586364|E1|Reported Event|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
145390|NCT01586338|B1|Baseline|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
145391|NCT01586338|P1|Participant Flow|Synvisc|Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
145392|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
145393|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
145394|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
145395|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
145396|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
145397|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
145398|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
145399|NCT01586338|E1|Reported Event|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
145400|NCT01586312|B3|Baseline|Total|Total of all reporting groups
145401|NCT01586312|B2|Baseline|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
145402|NCT01586312|B1|Baseline|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
145403|NCT01586312|P2|Participant Flow|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
145404|NCT01586312|P1|Participant Flow|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
145405|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
145406|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
145407|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
145408|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
145409|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
145410|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
145411|NCT01586312|E2|Reported Event|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
145412|NCT01586312|E1|Reported Event|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
145413|NCT01586195|B1|Baseline|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
145414|NCT01586195|P1|Participant Flow|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 milligram (mg) orally twice daily (BID) until disease progression.
145415|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
145416|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
145417|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
145840|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily"
145418|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
145419|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
145420|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
145421|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
145422|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
145423|NCT01586195|E1|Reported Event|Vemurafenib|Participants received vemurafenib 960 mg orally BID.
145424|NCT01586026|B1|Baseline|Combined Demographics|Demographics of 171 subjects that contributed to final data analysis
145425|NCT01586026|P3|Participant Flow|Group C|Maintenance flushes at days 57+
145426|NCT01586026|P2|Participant Flow|Group B|Maintenance flushes at days 29-56
145427|NCT01586026|P1|Participant Flow|Group A|Maintenance flushes at days 1-28
145428|NCT01586026|O3|Outcome|Group C|Maintenance flushes at days 57+
145429|NCT01586026|O2|Outcome|Group B|Maintenance flushes at days 29-56
145430|NCT01586026|O1|Outcome|Group A|Maintenance flushes at days 1-28
145431|NCT01586026|E3|Reported Event|Group C|Maintenance flushes at days 57+
145432|NCT01586026|E2|Reported Event|Group B|Maintenance flushes at days 29-56
145433|NCT01586026|E1|Reported Event|Group A|Maintenance flushes at days 1-28
145434|NCT01585987|B3|Baseline|Total|Total of all reporting groups
145435|NCT01585987|B2|Baseline|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment.
145436|NCT01585987|B1|Baseline|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
145437|NCT01585987|P2|Participant Flow|All Best Supportive Care (BSC)|All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used
145438|NCT01585987|P1|Participant Flow|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
145439|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
145440|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
145825|NCT01585246|O1|Outcome|Phase 1: Men in 320mg/Day DFP|Men assigned to the 320mg/Day group in the dose finding phase.
145441|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
145442|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
145443|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
145444|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
145445|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
145537|NCT01585558|P3|Participant Flow|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
146056|NCT01584388|O1|Outcome|Complete Remission (Any Timepoint)|IgG4-RD RI = 0 at any point in the trial
145446|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
145447|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
145448|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
145449|NCT01585987|E3|Reported Event|Non-Active BSC|Non-Active BSC involves supportive care with cessation of chemotherapy (no active drug)
145450|NCT01585987|E2|Reported Event|Active Best Supportive Care (BSC)|Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization)
145451|NCT01585987|E1|Reported Event|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
145452|NCT01585961|B1|Baseline|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145453|NCT01585961|P1|Participant Flow|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145454|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145455|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145456|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145457|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145458|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145459|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145460|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145461|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145538|NCT01585558|P2|Participant Flow|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145539|NCT01585558|P1|Participant Flow|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145462|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145463|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145464|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145465|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145466|NCT01585961|E1|Reported Event|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
145467|NCT01585779|B3|Baseline|Total|Total of all reporting groups
145468|NCT01585779|B2|Baseline|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145469|NCT01585779|B1|Baseline|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145470|NCT01585779|P2|Participant Flow|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145471|NCT01585779|P1|Participant Flow|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145472|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145473|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145826|NCT01585246|E3|Reported Event|Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
145474|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145475|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145540|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145541|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145476|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145477|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145478|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145479|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145480|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145481|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145482|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145483|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145484|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145485|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145486|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145529|NCT01585584|B1|Baseline|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
145573|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145487|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145488|NCT01585779|O2|Outcome|Tri-Ad® Implant|The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
145489|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145490|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145491|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145492|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145493|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145494|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145495|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145496|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145497|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145498|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145499|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145530|NCT01585584|P1|Participant Flow|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
145574|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145500|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145501|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145502|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145503|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145504|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145505|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145506|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145507|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145508|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145509|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145510|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145511|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145512|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145531|NCT01585584|O1|Outcome|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
145575|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145513|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145514|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145515|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145516|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145517|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145518|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145519|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145520|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145521|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145522|NCT01585779|E2|Reported Event|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145523|NCT01585779|E1|Reported Event|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure
Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
145524|NCT01585597|B1|Baseline|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.
Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
145525|NCT01585597|P1|Participant Flow|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.
Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
145526|NCT01585597|O1|Outcome|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.
Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
145527|NCT01585597|O1|Outcome|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.
Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
145528|NCT01585597|E1|Reported Event|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.
Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
145572|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145532|NCT01585584|E1|Reported Event|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
145533|NCT01585558|B4|Baseline|Total|Total of all reporting groups
145534|NCT01585558|B3|Baseline|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145535|NCT01585558|B2|Baseline|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145536|NCT01585558|B1|Baseline|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145542|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145543|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145544|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145545|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145546|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145547|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145548|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145549|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145550|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145551|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145552|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145553|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145554|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145555|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145556|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145557|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145558|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145559|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145560|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145561|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145562|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145563|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145564|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145565|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145566|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145567|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145568|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145569|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145570|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145571|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
153068|NCT01552928|E4|Reported Event|Placebo|
145576|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145577|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145578|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145579|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145580|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145581|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145582|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145583|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145584|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145585|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145586|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145587|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145588|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145589|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145590|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145591|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145592|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145593|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145594|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145595|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145596|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145597|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145598|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145599|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145600|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145601|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145602|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145603|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145604|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145605|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145606|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145607|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145608|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145609|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145610|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145611|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145612|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145613|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145614|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145615|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
153069|NCT01552928|E3|Reported Event|Moxifloxacin 400mg|
145616|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145617|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145618|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145619|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145620|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145621|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145622|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145623|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145624|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145625|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145626|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145627|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145628|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145629|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145630|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145631|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145632|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145633|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145634|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145635|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145636|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145637|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145638|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145639|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145640|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145641|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145642|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145643|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145644|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145645|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145646|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145647|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145648|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145649|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145650|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145651|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145652|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145653|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145654|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145655|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
153070|NCT01552928|E2|Reported Event|Anagrelide 2.5mg|
145656|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145657|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145658|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145659|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145660|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145661|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145662|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145663|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145664|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145665|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145666|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145667|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145668|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145669|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145670|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145671|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145672|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145673|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145674|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145675|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145676|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145677|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145678|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145679|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145680|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145681|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145682|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145683|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145684|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145685|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145686|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145687|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145688|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145689|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145690|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145691|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145692|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145693|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145694|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145695|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
153071|NCT01552928|E1|Reported Event|Anagrelide 0.5mg|
145696|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145697|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145698|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145699|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145700|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145701|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145702|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145703|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145704|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145705|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145706|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145707|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145708|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145709|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145710|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145711|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145712|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145713|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145714|NCT01585558|E3|Reported Event|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
145715|NCT01585558|E2|Reported Event|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
145716|NCT01585558|E1|Reported Event|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
145717|NCT01585441|B3|Baseline|Total|Total of all reporting groups
145718|NCT01585441|B2|Baseline|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145719|NCT01585441|B1|Baseline|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145720|NCT01585441|P2|Participant Flow|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145721|NCT01585441|P1|Participant Flow|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145722|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145723|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145724|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145725|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145726|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145727|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145728|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145729|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145730|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145731|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145732|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145733|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145734|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145834|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily"
145735|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145736|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145737|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145738|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145739|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145740|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145741|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145742|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145743|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145744|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145745|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145746|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145747|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145748|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145749|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145750|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145751|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145752|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145753|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145754|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145755|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145756|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145757|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145758|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145759|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145760|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145761|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145762|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145763|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145764|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145765|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145766|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145767|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145768|NCT01585441|E2|Reported Event|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
Placebo: Capsule with no active ingredients to mimic finasteride"
145769|NCT01585441|E1|Reported Event|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
145770|NCT01585428|B3|Baseline|Total|Total of all reporting groups
145771|NCT01585428|B2|Baseline|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
145791|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
146153|NCT01583530|O2|Outcome|Belimumab SC x 1 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
145772|NCT01585428|B1|Baseline|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
145773|NCT01585428|P2|Participant Flow|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
145835|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening"
145774|NCT01585428|P1|Participant Flow|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
145775|NCT01585428|O2|Outcome|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
145776|NCT01585428|O1|Outcome|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
145777|NCT01585428|O2|Outcome|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
145778|NCT01585428|O1|Outcome|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
145779|NCT01585428|E2|Reported Event|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
145819|NCT01585246|O2|Outcome|Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
145820|NCT01585246|O1|Outcome|Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
145780|NCT01585428|E1|Reported Event|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.
Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
145781|NCT01585324|B1|Baseline|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
145836|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily"
145837|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening"
154332|NCT01545700|O19|Outcome|Dexamethasone 4 mg 8-24 Hours-baseline|
145782|NCT01585324|P1|Participant Flow|Peginterferon Alpha-2a + Ribavirin|Participants infected with hepatitis C virus (HCV) genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 micrograms (mcg) subcutaneously once a week and ribavirin tablet, 1000-1200 milligrams (mg) by body weight (1000 mg if weight less than (<) 75 kilogram [kg]; 1200 mg if weight greater than or equal to (≥) 75 kg) orally split into 2 daily doses, for a total of 48 weeks.
145783|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
145784|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
145785|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
145786|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
145787|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
145788|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
145789|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
145790|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
145821|NCT01585246|O5|Outcome|Phase 2: Placebo RCT|Men assigned to the placebo in the pilot RCT Phase
145822|NCT01585246|O4|Outcome|Phase 2: Saw Palmetto 960 mg RCT|Men assigned to the 960mg/Day of Saw Palmetto in the pilot RCT Phase
145823|NCT01585246|O3|Outcome|Phase 1: Men in 960mg/Day DFP|Men assigned to the 960mg/Day group in the dose finding phase.
145824|NCT01585246|O2|Outcome|Phase 1: Men in 640mg/Day DFP|Men assigned to the 640mg/Day group in the dose finding phase.
145792|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
145793|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
145838|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily"
154333|NCT01545700|O18|Outcome|Placebo 8-24 Hours-24 Hours|
145794|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
145795|NCT01585324|O1|Outcome|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
145796|NCT01585324|E1|Reported Event|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
145797|NCT01585272|B1|Baseline|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
145798|NCT01585272|P1|Participant Flow|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
145799|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
145800|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
145801|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
145802|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
145803|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
145804|NCT01585272|E1|Reported Event|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
145805|NCT01585246|B6|Baseline|Total|Total of all reporting groups
145806|NCT01585246|B5|Baseline|Placebo Comparator: Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
145807|NCT01585246|B4|Baseline|Active Comparator: Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg
145808|NCT01585246|B3|Baseline|Phase 1: Saw Palmetto Soft Gel 960mg/Day|Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.
145809|NCT01585246|B2|Baseline|Phase 1: Saw Palmetto Soft Gel 640mg/Day|Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
145810|NCT01585246|B1|Baseline|Phase 1: Saw Palmetto Soft Gel 320mg/Day|Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
145811|NCT01585246|P5|Participant Flow|Phase 2: RCT Phase- Placebo|Patients received Soybean Oil Soft Gel as the placebo treatment
145812|NCT01585246|P4|Participant Flow|Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
145813|NCT01585246|P3|Participant Flow|Phase 1: Saw Palmetto Soft Gel 960mg/Day|Participants in this arm received 960mg/day of Saw Palmetto Soft Gel capsules.
145814|NCT01585246|P2|Participant Flow|Phase 1: Saw Palmentto Soft Gel 640mg/Day|Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
145815|NCT01585246|P1|Participant Flow|Phase 1: Saw Palmetto Soft Gel 320mg/Day|Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
145816|NCT01585246|O3|Outcome|Phase I: Saw Palmetto Soft Gel 960mg/Day|Participants in this arm received 960 mg/day of Saw Palmetto Soft Gel capsules.
145817|NCT01585246|O2|Outcome|Phase I: Saw Palmetto Soft Gel 640mg/Day|Participants in this arm received 640mg/day of Saw Palmetto Soft Gel capsules.
145818|NCT01585246|O1|Outcome|Phase 1: Saw Palmetto Soft Gel 320mg/Day|Participants in this arm received 320mg/day of Saw Palmetto Soft Gel capsules.
145827|NCT01585246|E2|Reported Event|Phase 2: RCT Phase- Saw Palmetto|Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960 mg.
145828|NCT01585246|E1|Reported Event|Phase 1: The Dose Finding Phase (DFP)|Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose.
145829|NCT01585038|B3|Baseline|Total|Total of all reporting groups
145830|NCT01585038|B2|Baseline|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily"
145831|NCT01585038|B1|Baseline|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening"
145832|NCT01585038|P2|Participant Flow|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily"
145833|NCT01585038|P1|Participant Flow|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening"
146278|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
145841|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening"
145842|NCT01585038|E2|Reported Event|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily"
145843|NCT01585038|E1|Reported Event|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening"
145844|NCT01584843|B5|Baseline|Total|Total of all reporting groups
145845|NCT01584843|B4|Baseline|GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145846|NCT01584843|B3|Baseline|GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD or with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145847|NCT01584843|B2|Baseline|GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145848|NCT01584843|B1|Baseline|Non-treatment, Then GSK1358820|Participants (par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD or with a BSA >=20 PD and <50 PD received no treatment from the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145849|NCT01584843|P6|Participant Flow|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145965|NCT01584648|P2|Participant Flow|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146321|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
145850|NCT01584843|P5|Participant Flow|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145851|NCT01584843|P4|Participant Flow|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145990|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146279|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
145852|NCT01584843|P3|Participant Flow|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145853|NCT01584843|P2|Participant Flow|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145854|NCT01584843|P1|Participant Flow|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145855|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145856|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145857|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145966|NCT01584648|P1|Participant Flow|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145967|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145858|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145875|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145859|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145860|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145861|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145862|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145863|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145864|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145865|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145968|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146010|NCT01584544|P4|Participant Flow|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
145866|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145867|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145868|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145869|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145870|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145871|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145872|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145873|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145969|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146011|NCT01584544|P3|Participant Flow|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
145874|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145876|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145877|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145878|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145879|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145880|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145881|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145970|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145971|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145882|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145986|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145987|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146341|NCT01582282|B4|Baseline|Total|Total of all reporting groups
145883|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145884|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145885|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145886|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145887|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145888|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145889|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145972|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145973|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145988|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145989|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
154334|NCT01545700|O17|Outcome|Placebo 8-24 Hours-8 Hours|
145890|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145891|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145892|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145893|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145894|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145895|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145896|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145897|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145974|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146012|NCT01584544|P2|Participant Flow|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
145898|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145899|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145900|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145901|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145902|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145903|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145904|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145905|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145975|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145976|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145906|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145907|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145908|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145909|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145910|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145911|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145912|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145913|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145977|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145985|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145914|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145915|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145916|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145917|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145918|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145919|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145920|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145921|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145978|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146007|NCT01584544|B2|Baseline|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
145922|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145923|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145924|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145925|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145926|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145927|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145928|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145929|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145979|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145980|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145930|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145931|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145932|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145933|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145934|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145935|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145936|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145937|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145981|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146008|NCT01584544|B1|Baseline|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.
capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
153072|NCT01552915|B4|Baseline|Total|Total of all reporting groups
145938|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145939|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145940|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145941|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145942|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145943|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145944|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145945|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145982|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146009|NCT01584544|P5|Participant Flow|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
145946|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145947|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145948|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145949|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145950|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145951|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145952|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145953|NCT01584843|O4|Outcome|SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145983|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145984|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145954|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145955|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145956|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145957|NCT01584843|E5|Reported Event|GSK1358820 5.0 U|Par with a BSA greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145958|NCT01584843|E4|Reported Event|GSK1358820 2.5 U|Participants with BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145959|NCT01584843|E3|Reported Event|GSK1358820 1.25 U|Par with a BSA greater than or equal to 10 PD and less than 20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
145960|NCT01584843|E2|Reported Event|Non-treatment, Then GSK1358820|Par with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
145961|NCT01584843|E1|Reported Event|Non-treatment|Participants (par) with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the First Treatment Period (FTP). Par were re-evaluated at Week 4 and Weeks 12-24. Par who did not meet the injection criteria at any time point remained in the FTP group and were observed up to study Week 52.
145962|NCT01584648|B3|Baseline|Total|Total of all reporting groups
145963|NCT01584648|B2|Baseline|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145964|NCT01584648|B1|Baseline|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
155072|NCT01543074|B5|Baseline|Total|Total of all reporting groups
145991|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145992|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145993|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145994|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145995|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145996|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145997|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145998|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
145999|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146000|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146001|NCT01584648|E2|Reported Event|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146002|NCT01584648|E1|Reported Event|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
146003|NCT01584544|B6|Baseline|Total|Total of all reporting groups
146004|NCT01584544|B5|Baseline|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146005|NCT01584544|B4|Baseline|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146006|NCT01584544|B3|Baseline|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146154|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
146013|NCT01584544|P1|Participant Flow|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.
capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146014|NCT01584544|O5|Outcome|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146015|NCT01584544|O4|Outcome|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146016|NCT01584544|O3|Outcome|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146017|NCT01584544|O2|Outcome|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146018|NCT01584544|O1|Outcome|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.
capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146055|NCT01584388|O1|Outcome|Complete Remission at Any Timepoint, Exclusive of Serum IgG4|IgG4-RD RI = 0 (exclusive of serum IgG4) at any point in the trial
154335|NCT01545700|O16|Outcome|Placebo 8-24 Hours Baseline|
146019|NCT01584544|E5|Reported Event|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146020|NCT01584544|E4|Reported Event|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146021|NCT01584544|E3|Reported Event|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146022|NCT01584544|E2|Reported Event|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146023|NCT01584544|E1|Reported Event|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.
capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
146024|NCT01584518|B3|Baseline|Total|Total of all reporting groups
146025|NCT01584518|B2|Baseline|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
146026|NCT01584518|B1|Baseline|CHF Peptide|"Diuresis based on CHF-P
Furosemide: Based on clinical standard per clinician"
146027|NCT01584518|P2|Participant Flow|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
146028|NCT01584518|P1|Participant Flow|CHF Peptide|"Diuresis based on CHF-P
Furosemide: Based on clinical standard per clinician"
146029|NCT01584518|O2|Outcome|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
146030|NCT01584518|O1|Outcome|CHF Peptide|"Diuresis based on CHF-P
Furosemide: Based on clinical standard per clinician"
146031|NCT01584518|E2|Reported Event|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
146032|NCT01584518|E1|Reported Event|CHF Peptide|"Diuresis based on CHF-P
Furosemide: Based on clinical standard per clinician"
146033|NCT01584479|B5|Baseline|Total|Total of all reporting groups
146034|NCT01584479|B4|Baseline|High Risk Control Group|"2 visits - High Risk
~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
146035|NCT01584479|B3|Baseline|High Risk Experimental Group|"1 visit - High Risk
~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
146036|NCT01584479|B2|Baseline|Low Risk Control Group|"2 visits - Low Risk
~1200 subjects
- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
146037|NCT01584479|B1|Baseline|Low Risk Experimental Group|"1 visit - Low Risk
~1200 subjects
- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
146038|NCT01584479|P4|Participant Flow|High Risk Control Group|"2 visits - High Risk 1,847 evaluable subjects
High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
146039|NCT01584479|P3|Participant Flow|High Risk Experimental Group|"1 visit - High Risk 852 evaluable subjects
High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
146040|NCT01584479|P2|Participant Flow|Low Risk Control Group|"2 visits - Low Risk 1,668 evaluable subjects
- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
146041|NCT01584479|P1|Participant Flow|Low Risk Experimental Group|"1 visit - Low Risk 732 evaluable subjects
- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
146042|NCT01584479|O4|Outcome|High Risk Control Group|"2 visits - High Risk
~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
146043|NCT01584479|O3|Outcome|High Risk Experimental Group|"1 visit - High Risk
~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
146044|NCT01584479|O2|Outcome|Low Risk Control Group|"2 visits - Low Risk
~1200 subjects
- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
146045|NCT01584479|O1|Outcome|Low Risk Experimental Group|"1 visit - Low Risk
~1200 subjects
- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
146155|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
157481|NCT01533116|B5|Baseline|Total|Total of all reporting groups
146046|NCT01584479|E4|Reported Event|High Risk Control Group|"2 visits - High Risk
~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
146047|NCT01584479|E3|Reported Event|High Risk Experimental Group|"1 visit - High Risk
~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
146048|NCT01584479|E2|Reported Event|Low Risk Control Group|"2 visits - Low Risk
~1200 subjects
- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
146049|NCT01584479|E1|Reported Event|Low Risk Experimental Group|"1 visit - Low Risk
~1200 subjects
- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
146050|NCT01584388|B1|Baseline|Rituximab|Rituximab: Rituximab 1000 mg IV times two doses, separated by approximately 15 days.
146051|NCT01584388|P1|Participant Flow|Rituximab|Rituximab: Rituximab 1000 mg IV times two doses, separated by approximately 15 days.
146052|NCT01584388|O1|Outcome|Time to Complete Remission|Time to achievement of IgG4-RD RI of 0
146053|NCT01584388|O1|Outcome|Time to Relapse|Time to increase in IgG4-RD RI and reinstitution of treatment
146054|NCT01584388|O1|Outcome|Time to Disease Response|Time to achievement of IgG4-RD RI improvement of > 2
146057|NCT01584388|O1|Outcome|Complete Remission at 6 Months, Exclusive of Serum IgG4|IgG-RD RI (exclusive of serum IgG4) of 0 at 6 months.
146058|NCT01584388|O1|Outcome|Complete Remission at 6 Months|IgG-RD RI (exclusive of serum IgG4) of 0 at 6 months.
146059|NCT01584388|O1|Outcome|Disease Response at 12 Months|Decline of IgG4-RD RI by at least 2 points and maintained at 12 months.
146060|NCT01584388|O1|Outcome|Disease Response at 6 Months|Decline of IgG4-RD RI by at least 2 points and maintained at 6 months.
146061|NCT01584388|O1|Outcome|Relapse Treatment|Rituximab treatment for relapse
146062|NCT01584388|O1|Outcome|Disease Flare|no disease flare before month 6
146063|NCT01584388|O2|Outcome|Glucocorticoid Use (6 Months)|total prednisone dose equivalent admin over 28 days prior to the 6 month study visit
146064|NCT01584388|O1|Outcome|Glucocorticoid Treatment (Baseline)|total prednisone dose equivalent (mg) admin in the 28 preceding enrollment)
146065|NCT01584388|O2|Outcome|6 Months|IgG4-RD Responder Index 6 months after treatment
146066|NCT01584388|O1|Outcome|IgG4-RD Responder Index|Scoring at baseline
146067|NCT01584388|E1|Reported Event|Open Label Treatment With Rituximab|Rituximab 1000 mg IV times two doses, separated by approximately 15 days
146068|NCT01584232|B3|Baseline|Total|Total of all reporting groups
146069|NCT01584232|B2|Baseline|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146070|NCT01584232|B1|Baseline|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146071|NCT01584232|P2|Participant Flow|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146072|NCT01584232|P1|Participant Flow|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146073|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146074|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146075|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146076|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146106|NCT01582789|E2|Reported Event|Senofilcon A/Enfilcon A|"senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd
enfilcon A: enfilcon A daily wear soft contact lens
senofilcon A: senofilcon A daily wear soft contact lens"
146156|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
146077|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146078|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146079|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146080|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146116|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146081|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146082|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146083|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146084|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146085|NCT01584232|E2|Reported Event|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146086|NCT01584232|E1|Reported Event|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
146087|NCT01583894|B1|Baseline|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
146088|NCT01583894|P1|Participant Flow|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
146089|NCT01583894|O1|Outcome|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
146090|NCT01583894|E1|Reported Event|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
146091|NCT01582789|B1|Baseline|Overall Study Group Prior to Dispense|All subjects prior to dispense of first set of study lenses
146092|NCT01582789|P2|Participant Flow|Senofilcon A, Then Enfilcon A|"senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd
enfilcon A: enfilcon A daily wear soft contact lens
senofilcon A: senofilcon A daily wear soft contact lens"
146093|NCT01582789|P1|Participant Flow|Enfilcon A, Then Senofilcon A|"enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd
enfilcon A: enfilcon A daily wear soft contact lens
senofilcon A: senofilcon A daily wear soft contact lens"
146094|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
146095|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
146096|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
146097|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
146098|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
146099|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
146100|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
146101|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
146102|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
146103|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
146104|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
146105|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
146107|NCT01582789|E1|Reported Event|Enfilcon A/Senofilcon A|"enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd
enfilcon A: enfilcon A daily wear soft contact lens
senofilcon A: senofilcon A daily wear soft contact lens"
146108|NCT01583647|B1|Baseline|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146109|NCT01583647|P2|Participant Flow|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146110|NCT01583647|P1|Participant Flow|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146111|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146112|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146113|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146114|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146115|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146117|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146118|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146119|NCT01583647|E2|Reported Event|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146120|NCT01583647|E1|Reported Event|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
146121|NCT01583543|B1|Baseline|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
146122|NCT01583543|P1|Participant Flow|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
146123|NCT01583543|O1|Outcome|Olaparib|"400mg PO BID Continuous
Olaparib: 400mg PO BID Continuous"
146124|NCT01583543|O1|Outcome|Olaparib|This group of patients with metastatic Ewing sarcoma received single agent olaparib therapy.
146125|NCT01583543|O1|Outcome|Olaparib|This group of patients with metastatic Ewing sarcoma received single agent olaparib.
146126|NCT01583543|O1|Outcome|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
146127|NCT01583543|E1|Reported Event|Olaparib|400 mg PO BID Continuous Olaparib
146128|NCT01583530|B7|Baseline|Total|Total of all reporting groups
146129|NCT01583530|B6|Baseline|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
146130|NCT01583530|B5|Baseline|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
146131|NCT01583530|B4|Baseline|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
146132|NCT01583530|B3|Baseline|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
146133|NCT01583530|B2|Baseline|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
146134|NCT01583530|B1|Baseline|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
146135|NCT01583530|P6|Participant Flow|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
146136|NCT01583530|P5|Participant Flow|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
146137|NCT01583530|P4|Participant Flow|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
146138|NCT01583530|P3|Participant Flow|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
146139|NCT01583530|P2|Participant Flow|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
146140|NCT01583530|P1|Participant Flow|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
146141|NCT01583530|O6|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
146142|NCT01583530|O5|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
146143|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
146144|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
146145|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
146146|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
146147|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
146148|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
146149|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
146150|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
146151|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
146152|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
146157|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
146158|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
146159|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
146160|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
146161|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
146162|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
146163|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
146164|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
146165|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
146166|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
146167|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
146168|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
146169|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
146170|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
146171|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
146172|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
146173|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
146174|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
146175|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
146176|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
146177|NCT01583530|E6|Reported Event|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
146178|NCT01583530|E5|Reported Event|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
146179|NCT01583530|E4|Reported Event|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
146180|NCT01583530|E3|Reported Event|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
146181|NCT01583530|E2|Reported Event|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
146182|NCT01583530|E1|Reported Event|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
146183|NCT01583452|B3|Baseline|Total|Total of all reporting groups
146184|NCT01583452|B2|Baseline|No Intervention|By observing the clinical evolution of the participants not given chewing gum as prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
146185|NCT01583452|B1|Baseline|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care.
Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
146186|NCT01583452|P2|Participant Flow|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
146187|NCT01583452|P1|Participant Flow|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.
Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
146188|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
146189|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.
Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
146190|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
146191|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care.
Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
146192|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
146193|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.
Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
146194|NCT01583452|O2|Outcome|Control Group|The time between the end of surgery and the discharge of the patient measured in hours.
146195|NCT01583452|O1|Outcome|Chewing Gum Group|The time between the end of the surgery and the discharge of the patients, measured in hours.
146196|NCT01583452|E2|Reported Event|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
146197|NCT01583452|E1|Reported Event|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.
Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
146199|NCT01583374|B3|Baseline|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
146200|NCT01583374|B2|Baseline|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
146201|NCT01583374|B1|Baseline|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
146202|NCT01583374|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
146203|NCT01583374|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
146204|NCT01583374|P1|Participant Flow|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
146205|NCT01583374|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase..
146206|NCT01583374|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
146207|NCT01583374|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
146208|NCT01583374|O2|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
146209|NCT01583374|O1|Outcome|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
154336|NCT01545700|O15|Outcome|Dexamethasone 8 mg 0-4 Hours-4 Hours|
146210|NCT01583374|E3|Reported Event|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo controlled treatment phase.
146211|NCT01583374|E2|Reported Event|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo controlled treatment phase.
146212|NCT01583374|E1|Reported Event|Placebo|Participants initially randomized to receive placebo tablets twice daily.
146213|NCT01583101|B3|Baseline|Total|Total of all reporting groups
146214|NCT01583101|B2|Baseline|Receiving Non-highlighted Prompts|These patients received prompts that were not highlighted.
146215|NCT01583101|B1|Baseline|Receiving Highlighted Prompts|These patients received highlighted prompts.
146216|NCT01583101|P2|Participant Flow|Non-highlighted Prompts|Physicians received prompts that were not highlighted.
146217|NCT01583101|P1|Participant Flow|Highlighted Prompts|Physicians received highlighted prompts.
146218|NCT01583101|O2|Outcome|Receiving Non-highlighted Prompts|Prompts received by physicians were not highlighted.
146219|NCT01583101|O1|Outcome|Receiving Highlighted Prompts|Prompts received by physicians were highlighted.
146220|NCT01583101|E2|Reported Event|Non-highlighted Prompts|These patients received prompts that were not highlighted.
146221|NCT01583101|E1|Reported Event|Highlighted Prompts|These patients received highlighted prompts.
146222|NCT01582945|B1|Baseline|Treatment-resistant Depression Patients|Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
146223|NCT01582945|P1|Participant Flow|Treatment-resistant Depression Patients|Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
146224|NCT01582945|O1|Outcome|Ketamine IV|"Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg over the course of 45 minutes, twice a week for 3 weeks. Participants received this dosage for the first three of six IV ketamine infusions. If participants do not experience an improvement of greater or equal to 30% in HAM-D scores after the first three infusions, the dose will be increased to 0.75mg/kg for the subsequent three infusions.
Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen"
146225|NCT01582945|E1|Reported Event|Ketamine IV|"Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks
Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen"
146226|NCT01582880|B1|Baseline|Riboflavin Cross-linked Donor Cornea|"the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.
Riboflavin: Used to treat donor cornea before implantation"
146227|NCT01582880|P1|Participant Flow|Riboflavin Cross-linked Donor Cornea|"the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.
Riboflavin: Used to treat donor cornea before implantation"
146228|NCT01582880|O1|Outcome|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.
Riboflavin: Used to treat donor cornea before implantation"
146229|NCT01582880|O1|Outcome|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.
Riboflavin: Used to treat donor cornea before implantation"
146230|NCT01582880|O1|Outcome|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.
Riboflavin: Used to treat donor cornea before implantation"
146231|NCT01582880|O1|Outcome|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.
Riboflavin: Used to treat donor cornea before implantation"
146232|NCT01582880|O1|Outcome|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.
Riboflavin: Used to treat donor cornea before implantation"
146233|NCT01582880|E1|Reported Event|Riboflavin Cross-linked Donor Cornea|"The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.
Riboflavin: Used to treat donor cornea before implantation"
146234|NCT01582854|B3|Baseline|Total|Total of all reporting groups
157824|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
146235|NCT01582854|B2|Baseline|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146236|NCT01582854|B1|Baseline|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146237|NCT01582854|P2|Participant Flow|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146238|NCT01582854|P1|Participant Flow|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146239|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146240|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146241|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146242|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146277|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
146243|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146244|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146245|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146246|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146247|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146248|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146249|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146250|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146251|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146252|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146253|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146254|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146255|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146256|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146257|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146258|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146259|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146260|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146261|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146262|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146263|NCT01582854|E2|Reported Event|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
146264|NCT01582854|E1|Reported Event|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
146265|NCT01582490|B3|Baseline|Total|Total of all reporting groups
146266|NCT01582490|B2|Baseline|Instillation - EXPAREL|"Group 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery.
Infiltration - EXPAREL: IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed."
146317|NCT01582308|P1|Participant Flow|Treatment Sequence 1|Sitagliptin 100 mg in Period 1 followed by saxagliptin 5 mg in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg in Period 5
146318|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
146267|NCT01582490|B1|Baseline|Infiltration - EXPAREL|"Group 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery.
Instillation - EXPAREL: Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed."
146268|NCT01582490|P2|Participant Flow|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
146269|NCT01582490|P1|Participant Flow|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
146270|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
146271|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
146272|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
146273|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
146274|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
146275|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
146276|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
146280|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
146281|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
146282|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
146283|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
146284|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
146285|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
146286|NCT01582490|E2|Reported Event|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
146287|NCT01582490|E1|Reported Event|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
146288|NCT01582477|B3|Baseline|Total|Total of all reporting groups
146289|NCT01582477|B2|Baseline|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
146290|NCT01582477|B1|Baseline|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
146291|NCT01582477|P2|Participant Flow|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
146292|NCT01582477|P1|Participant Flow|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
146293|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
146294|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
146295|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
146296|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
146297|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
146298|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
146299|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
146300|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
146301|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
146302|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
146303|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
146304|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
146305|NCT01582477|E2|Reported Event|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
146306|NCT01582477|E1|Reported Event|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
146307|NCT01582308|B1|Baseline|All Enrolled Participants|
146308|NCT01582308|P10|Participant Flow|Treatment Sequence 10|Placebo in Period 1 followed by saxagliptin 5 mg in Period 2 followed by sitagliptin 100 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by vildagliptin 50 mg in Period 5
146309|NCT01582308|P9|Participant Flow|Treatment Sequence 9|Vildagliptin 50 mg BID in Period 1 followed by sitagliptin 100 mg in Period 2 followed by placebo in Period 3 followed by vildagliptin 50 mg in Period 4 followed by saxagliptin 5 mg in Period 5
146310|NCT01582308|P8|Participant Flow|Treatment Sequence 8|Vildagliptin 50 mg in Period 1 followed by placebo in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by saxagliptin 5 mg in Period 4 followed by sitagliptin 100 mg in Period 5
146311|NCT01582308|P7|Participant Flow|Treatment Sequence 7|Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by vildagliptin 50 mg in Period 3 followed by sitagliptin 100 mg in Period 4 followed by placebo in Period 5
146312|NCT01582308|P6|Participant Flow|Treatment Sequence 6|Sitagliptin 100 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by saxagliptin 5 mg in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg BID in Period 5
146313|NCT01582308|P5|Participant Flow|Treatment Sequence 5|Placebo in Period 1 followed by sitagliptin 100 mg in Period 2 followed by vildagliptin 50 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by saxagliptin 5 mg in Period 5
146314|NCT01582308|P4|Participant Flow|Treatment Sequence 4|Vildagliptin 50 mg BID in Period 1 followed by placebo in Period 2 followed by saxagliptin 5 mg in Period 3 followed by vildagliptin 50 mg in Period 4 followed by sitagliptin 100 mg in Period 5
146315|NCT01582308|P3|Participant Flow|Treatment Sequence 3|Vildagliptin 50 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by sitagliptin 100 mg in Period 3 followed by saxagliptin 5 mg in Period 4 followed by placebo in Period 5
146316|NCT01582308|P2|Participant Flow|Treatment Sequence 2|Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by placebo in Period 3 followed by sitagliptin 100 mg in Period 4 followed by vildagliptin 50 mg BID in Period 5
146319|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
146320|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
146322|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
146323|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
146324|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
146325|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
146326|NCT01582308|O1|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
146327|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
146328|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
146329|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
146330|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
146331|NCT01582308|O5|Outcome|Placebo|Placebo to sitagliptin daily for 5 days
146332|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
146333|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
146334|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
146335|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
146336|NCT01582308|E5|Reported Event|Placebo|Placebo to sitagliptin daily for 5 days
146337|NCT01582308|E4|Reported Event|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
146338|NCT01582308|E3|Reported Event|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
146339|NCT01582308|E2|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
146340|NCT01582308|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
146342|NCT01582282|B3|Baseline|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
146343|NCT01582282|B2|Baseline|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
146344|NCT01582282|B1|Baseline|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
146345|NCT01582282|P3|Participant Flow|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
146346|NCT01582282|P2|Participant Flow|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
146347|NCT01582282|P1|Participant Flow|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
146348|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
146349|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
146350|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
146351|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
146352|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
146353|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
146354|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
146355|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
146356|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
146357|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
146358|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
146359|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
146360|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
146361|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
146362|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
146363|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
146364|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
146365|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
146366|NCT01582282|E3|Reported Event|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
146367|NCT01582282|E2|Reported Event|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
146368|NCT01582282|E1|Reported Event|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
146369|NCT01582243|B1|Baseline|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
146370|NCT01582243|P1|Participant Flow|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
146371|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
146372|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
146373|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
146374|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
146375|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
146376|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
146377|NCT01582243|E1|Reported Event|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
146378|NCT01582178|B3|Baseline|Total|Total of all reporting groups
147889|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
146379|NCT01582178|B2|Baseline|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
146380|NCT01582178|B1|Baseline|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
146381|NCT01582178|P2|Participant Flow|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
146382|NCT01582178|P1|Participant Flow|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
146383|NCT01582178|O2|Outcome|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
146384|NCT01582178|O1|Outcome|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
146385|NCT01582178|E2|Reported Event|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
146386|NCT01582178|E1|Reported Event|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
146387|NCT01582139|B3|Baseline|Total|Total of all reporting groups
146430|NCT01581684|B10|Baseline|20/60mg PM|Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
154337|NCT01545700|O14|Outcome|Dexamethasone 8 mg 0-4 Hours-3 Hours|
146388|NCT01582139|B2|Baseline|Experimental First, Then Control|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
146389|NCT01582139|B1|Baseline|Control First, Then Experimental|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
146390|NCT01582139|P2|Participant Flow|Experimental First, Then Control|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
146391|NCT01582139|P1|Participant Flow|Control First, Then Experimental|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
146392|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
146393|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
146394|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
146395|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
146396|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
146397|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
146398|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
146399|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
146417|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
146418|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
146419|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
146400|NCT01582139|E2|Reported Event|Experimental: Heart Rate Informed SSM+HMM|"Experimental:
An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
146401|NCT01582139|E1|Reported Event|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
146402|NCT01582100|B1|Baseline|GERD Subjects With Nausea|Subjects who present with GERD along with nausea (with or without vomiting)
146403|NCT01582100|P1|Participant Flow|GERD Subjects With Nausea|Subjects who present with GERD along with nausea (with or without vomiting)
146404|NCT01582100|O1|Outcome|Single Arm Subjects With GERD/Nausea|This is a single arm study measuring the incidence and severity of nausea with or without vomiting in patients with GERD before and after treatment with Reletex
146405|NCT01582100|E1|Reported Event|Wrist Discomfort|subject did not like the feel of the device on wrist
146431|NCT01581684|B9|Baseline|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
146432|NCT01581684|B8|Baseline|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
146406|NCT01582009|B1|Baseline|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
panobinostat: Given orally
everolimus: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
liquid chromatography: Correlative studies
mass spectrometry: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
immunohistochemistry staining method: Correlative studies"
146407|NCT01582009|P1|Participant Flow|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
panobinostat: Given orally
everolimus: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
liquid chromatography: Correlative studies
mass spectrometry: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
immunohistochemistry staining method: Correlative studies"
146408|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
panobinostat: Given orally
everolimus: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
liquid chromatography: Correlative studies
mass spectrometry: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
immunohistochemistry staining method: Correlative studies"
146409|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
panobinostat: Given orally
everolimus: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
liquid chromatography: Correlative studies
mass spectrometry: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
immunohistochemistry staining method: Correlative studies"
146410|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
panobinostat: Given orally
everolimus: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
liquid chromatography: Correlative studies
mass spectrometry: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
immunohistochemistry staining method: Correlative studies"
146411|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
panobinostat: Given orally
everolimus: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
liquid chromatography: Correlative studies
mass spectrometry: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
immunohistochemistry staining method: Correlative studies"
146412|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
panobinostat: Given orally
everolimus: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
liquid chromatography: Correlative studies
mass spectrometry: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
immunohistochemistry staining method: Correlative studies"
146413|NCT01582009|E1|Reported Event|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
panobinostat: Given orally
everolimus: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
liquid chromatography: Correlative studies
mass spectrometry: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
immunohistochemistry staining method: Correlative studies"
146414|NCT01581931|B1|Baseline|Overall Study|This was an open-label, randomised, single dose, 2-way crossover trial with 2 treatments and 2 treatment sequences. The single dose administrations in each treatment period were separated by a washout period of at least 35 days.
146415|NCT01581931|P2|Participant Flow|Lina+Met FDC Tablet / Lina+Met Single Tablets|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in the first period. After a washout period of at least 35 days, the subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in period 2.
146416|NCT01581931|P1|Participant Flow|Lina+Met Single Tablets / Lina+Met FDC Tablet|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in the first period. After a washout period of at least 35 days, the subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in period 2.
146420|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
146421|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
146422|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
146423|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
146424|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
146425|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
146426|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
146427|NCT01581931|E2|Reported Event|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
146428|NCT01581931|E1|Reported Event|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
146429|NCT01581684|B11|Baseline|Total|Total of all reporting groups
146433|NCT01581684|B7|Baseline|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
146434|NCT01581684|B6|Baseline|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
146435|NCT01581684|B5|Baseline|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
146436|NCT01581684|B4|Baseline|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
146437|NCT01581684|B3|Baseline|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
146438|NCT01581684|B2|Baseline|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
146439|NCT01581684|B1|Baseline|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
146440|NCT01581684|P10|Participant Flow|20/60mg PM|Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
146441|NCT01581684|P9|Participant Flow|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
146442|NCT01581684|P8|Participant Flow|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
146443|NCT01581684|P7|Participant Flow|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
146444|NCT01581684|P6|Participant Flow|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
146445|NCT01581684|P5|Participant Flow|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
146446|NCT01581684|P4|Participant Flow|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
146447|NCT01581684|P3|Participant Flow|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
146448|NCT01581684|P2|Participant Flow|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
146449|NCT01581684|P1|Participant Flow|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
146450|NCT01581684|O11|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
146451|NCT01581684|O10|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
146452|NCT01581684|O9|Outcome|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
146453|NCT01581684|O8|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
146454|NCT01581684|O7|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
146455|NCT01581684|O6|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
146456|NCT01581684|O5|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
146457|NCT01581684|O4|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
146458|NCT01581684|O3|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
146459|NCT01581684|O2|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
146460|NCT01581684|O1|Outcome|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
146461|NCT01581684|O11|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
146462|NCT01581684|O10|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
146463|NCT01581684|O9|Outcome|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
146464|NCT01581684|O8|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
146465|NCT01581684|O7|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
146466|NCT01581684|O6|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
146467|NCT01581684|O5|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
146468|NCT01581684|O4|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
146469|NCT01581684|O3|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
146470|NCT01581684|O2|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
146471|NCT01581684|O1|Outcome|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
146472|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
146473|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
146474|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
146475|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
146476|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
146477|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
146478|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
146479|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
146480|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
146481|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
146482|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
146483|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
146484|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
146485|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
146486|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
146487|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
146488|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
146489|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
146490|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
146491|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
146492|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
146493|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
146494|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
146495|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
146496|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
146497|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
146498|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
146499|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
146500|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
146501|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
146502|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
146503|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
146504|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
146505|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
146506|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
146507|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
146508|NCT01581684|E11|Reported Event|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
146509|NCT01581684|E10|Reported Event|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
146510|NCT01581684|E9|Reported Event|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
146511|NCT01581684|E8|Reported Event|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
146512|NCT01581684|E7|Reported Event|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
146513|NCT01581684|E6|Reported Event|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
146514|NCT01581684|E5|Reported Event|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
146515|NCT01581684|E4|Reported Event|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
146516|NCT01581684|E3|Reported Event|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
146517|NCT01581684|E2|Reported Event|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
146518|NCT01581684|E1|Reported Event|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
146519|NCT01581658|B5|Baseline|Total|Total of all reporting groups
146520|NCT01581658|B4|Baseline|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
146521|NCT01581658|B3|Baseline|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
146522|NCT01581658|B2|Baseline|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
146523|NCT01581658|B1|Baseline|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
146524|NCT01581658|P4|Participant Flow|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
146525|NCT01581658|P3|Participant Flow|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
146526|NCT01581658|P2|Participant Flow|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
146527|NCT01581658|P1|Participant Flow|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
146528|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
146529|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
146530|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
146531|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
146532|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
146533|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
146534|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
146535|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
146536|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
146537|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
146538|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
146539|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
146540|NCT01581658|E4|Reported Event|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
146541|NCT01581658|E3|Reported Event|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
146542|NCT01581658|E2|Reported Event|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
146543|NCT01581658|E1|Reported Event|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
146544|NCT01581437|B1|Baseline|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
146545|NCT01581437|P1|Participant Flow|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
146546|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
64 pole basket catheter:"
146547|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
64 pole basket catheter:"
146548|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
64 pole basket catheter: Outcome:78 patients enrolled multicenter"
146549|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
146550|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
146551|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Outcome:78 patients enrolled multicenter"
146552|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Outcome:78 patients enrolled multicenter."
146553|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
146554|NCT01581437|E1|Reported Event|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
146555|NCT01581307|B1|Baseline|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
146556|NCT01581307|P1|Participant Flow|2nd Line Chemotherapy With Radiotherapy|"Administration of 2nd line chemotherapy will consist of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) will take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy is given every two weeks for 6‐10 cycles.
The goal of treatment with TheraSpheres is to allow a large dose of radiation to be delivered directly to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.
FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin): The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment.
TheraSpheres: TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors."
146557|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
146558|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
146649|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
146650|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
146559|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
146560|NCT01581307|E1|Reported Event|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
146561|NCT01581281|B4|Baseline|Total|Total of all reporting groups
146562|NCT01581281|B3|Baseline|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146563|NCT01581281|B2|Baseline|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
146564|NCT01581281|B1|Baseline|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146565|NCT01581281|P3|Participant Flow|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146566|NCT01581281|P2|Participant Flow|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
146567|NCT01581281|P1|Participant Flow|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146568|NCT01581281|O3|Outcome|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146569|NCT01581281|O2|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
146570|NCT01581281|O1|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146571|NCT01581281|O3|Outcome|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146572|NCT01581281|O2|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
146573|NCT01581281|O1|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146574|NCT01581281|O3|Outcome|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146634|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
146575|NCT01581281|O2|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
146576|NCT01581281|O1|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146577|NCT01581281|O3|Outcome|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146578|NCT01581281|O2|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
146579|NCT01581281|O1|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146580|NCT01581281|O3|Outcome|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146581|NCT01581281|O2|Outcome|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
146582|NCT01581281|O1|Outcome|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved
146583|NCT01581281|E3|Reported Event|Amitriptyline|Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146584|NCT01581281|E2|Reported Event|Placebo|Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
146585|NCT01581281|E1|Reported Event|Topiramate|Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
146586|NCT01581021|B3|Baseline|Total|Total of all reporting groups
146587|NCT01581021|B2|Baseline|Laminar Hooks|Group treated with hooks in the thoracic spine
146588|NCT01581021|B1|Baseline|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
146589|NCT01581021|P2|Participant Flow|Laminar Hooks|Group treated with hooks in the thoracic spine
146590|NCT01581021|P1|Participant Flow|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
146591|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
146592|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
146593|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
146594|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
146595|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
146596|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
146597|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
146598|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
146599|NCT01581021|E2|Reported Event|Laminar Hooks|Group treated with hooks in the thoracic spine
146600|NCT01581021|E1|Reported Event|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
146601|NCT01581008|B3|Baseline|Total|Total of all reporting groups
146602|NCT01581008|B2|Baseline|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
146603|NCT01581008|B1|Baseline|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
146604|NCT01581008|P2|Participant Flow|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
146635|NCT01580904|E2|Reported Event|Intervention Group|"Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
146636|NCT01580904|E1|Reported Event|Control Group|Patients will not be followed by the pharmacist.
146637|NCT01580618|B3|Baseline|Total|Total of all reporting groups
147890|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
146605|NCT01581008|P1|Participant Flow|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
146606|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
146607|NCT01581008|O2|Outcome|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
146651|NCT01580618|E2|Reported Event|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
146608|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
146609|NCT01581008|O2|Outcome|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
146610|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
146611|NCT01581008|E2|Reported Event|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
146612|NCT01581008|E1|Reported Event|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
146613|NCT01580995|B3|Baseline|Total|Total of all reporting groups
146614|NCT01580995|B2|Baseline|Placebo|"Matching placebo twice daily
Placebo: Placebo tablet twice daily"
146615|NCT01580995|B1|Baseline|Valacyclovir|"Valacyclovir 500 mg po bid
Valacyclovir: Valacyclovir 500 mg po bid"
146616|NCT01580995|P2|Participant Flow|Placebo|"Matching placebo twice daily
Placebo: Placebo tablet twice daily"
146617|NCT01580995|P1|Participant Flow|Valacyclovir|"Valacyclovir 500 mg po bid
Valacyclovir: Valacyclovir 500 mg po bid"
146618|NCT01580995|O2|Outcome|Placebo|"Matching placebo twice daily
Placebo: Placebo tablet twice daily"
146619|NCT01580995|O1|Outcome|Valacyclovir|"Valacyclovir 500 mg po bid
Valacyclovir: Valacyclovir 500 mg po bid"
146620|NCT01580995|E2|Reported Event|Placebo|"Matching placebo twice daily
Placebo: Placebo tablet twice daily"
146621|NCT01580995|E1|Reported Event|Valacyclovir|"Valacyclovir 500 mg po bid
Valacyclovir: Valacyclovir 500 mg po bid"
146622|NCT01580904|B3|Baseline|Total|Total of all reporting groups
146623|NCT01580904|B2|Baseline|Control Group|Patients will not be followed by the pharmacist.
146624|NCT01580904|B1|Baseline|Intervention Group|"Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
146625|NCT01580904|P2|Participant Flow|Control Group|Patients will not be followed by the pharmacist.
146626|NCT01580904|P1|Participant Flow|Intervention Group|"Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
146627|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.
Intervention: Pharmaceutical Care
Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
146628|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
146629|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.
Intervention: Pharmaceutical Care
Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
146630|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
146631|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.
Intervention: Pharmaceutical Care
Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
146632|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
146633|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
146638|NCT01580618|B2|Baseline|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
146639|NCT01580618|B1|Baseline|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
146640|NCT01580618|P2|Participant Flow|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
146641|NCT01580618|P1|Participant Flow|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
146642|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
146643|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
146644|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
146645|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
146646|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
146647|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
146648|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
146652|NCT01580618|E1|Reported Event|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
146653|NCT01580592|B4|Baseline|Total|Total of all reporting groups
146654|NCT01580592|B3|Baseline|Placebo|Placebo: Placebo, s.c., every 4 weeks
146655|NCT01580592|B2|Baseline|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
146656|NCT01580592|B1|Baseline|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
146657|NCT01580592|P3|Participant Flow|Placebo|Placebo: Placebo, s.c., every 4 weeks
146658|NCT01580592|P2|Participant Flow|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
146659|NCT01580592|P1|Participant Flow|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
146660|NCT01580592|O3|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
146661|NCT01580592|O2|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
146662|NCT01580592|O1|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
146663|NCT01580592|O3|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
146664|NCT01580592|O2|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
146665|NCT01580592|O1|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
146666|NCT01580592|E3|Reported Event|Placebo|Placebo: Placebo, s.c., every 4 weeks
146667|NCT01580592|E2|Reported Event|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
146668|NCT01580592|E1|Reported Event|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
146669|NCT01580488|B1|Baseline|All Study Participants|
146670|NCT01580488|P1|Participant Flow|All Study Participants|"Each of the 24 subjects received all 6 investigational products on small dermal test sites: Topical cream formulation B containing 20 mg/g LEO 35299 Topical cream formulation C containing 20 mg/g LEO 35299 Topical solution formulation E containing 10 mg/g LEO 35299 Topical solution formulation F containing 10 mg/g LEO 35299 Topical ointment containing 50 mcg/g calcipotriol Topical ointment vehicle"
146671|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
146672|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
146673|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
146674|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
146675|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
146676|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
146677|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
146678|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
146679|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
146680|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
146681|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
146682|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
146683|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
146684|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
146685|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
146686|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
146687|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
146688|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
146689|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
146690|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
146691|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
146692|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
146693|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
146694|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
146695|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
146696|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
146697|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
146698|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
146699|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
146700|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
146701|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
146702|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
146703|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
146704|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
146705|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
146706|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
146707|NCT01580488|E6|Reported Event|Daivonex® Ointment|Topical ointment vehicle
146708|NCT01580488|E5|Reported Event|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
146709|NCT01580488|E4|Reported Event|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
146710|NCT01580488|E3|Reported Event|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
146711|NCT01580488|E2|Reported Event|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
146712|NCT01580488|E1|Reported Event|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
146713|NCT01580423|B1|Baseline|Entire Study Population|Includes groups randomized to receive aprepitant first and inert powder first.
146714|NCT01580423|P2|Participant Flow|First Inert Powder, Then Aprepitant|Capsule of inert powder in first intervention period and capsule of aprepitant 125 mg in second intervention period.
146715|NCT01580423|P1|Participant Flow|First Aprepitant, Then Inert Powder|Capsule of aprepitant 125 mg in first intervention period and capsule of inert powder in second intervention period.
146716|NCT01580423|O2|Outcome|Inert Powder|Capsule containing insert powder
146717|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
146718|NCT01580423|O2|Outcome|Inert Powder|Capsule containing inert powder
146719|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
146720|NCT01580423|O2|Outcome|Inert Powder|Capsule containing inert powder
146721|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
146722|NCT01580423|E2|Reported Event|Inert Powder|Capsule filled with inert powder
146723|NCT01580423|E1|Reported Event|Aprepitant|Capsule filled with 125 mg of aprepitant
146724|NCT01580306|B5|Baseline|Total|Total of all reporting groups
146725|NCT01580306|B4|Baseline|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
146726|NCT01580306|B3|Baseline|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
146727|NCT01580306|B2|Baseline|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
146728|NCT01580306|B1|Baseline|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
146729|NCT01580306|P4|Participant Flow|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
146730|NCT01580306|P3|Participant Flow|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
146731|NCT01580306|P2|Participant Flow|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
146732|NCT01580306|P1|Participant Flow|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
146733|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
146734|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
146735|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
146736|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
146737|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
146738|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
146739|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
146740|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
146741|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
146742|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
146743|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
146744|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
146745|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
146746|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
146747|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
146748|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
146749|NCT01580306|E4|Reported Event|BI 201335 Relevant Treatment Dose (Severe Renal Impairment)|"Capsule for oral administration
estimated glomerular filtration rate 15-29 mL/min/1.73m2"
146750|NCT01580306|E3|Reported Event|BI 201335 Relevant Treatment Dose (Moderate Renal Impairment)|"Capsule for oral administration
estimated glomerular filtration rate 30-59 mL/min/1.73m2"
146751|NCT01580306|E2|Reported Event|BI 201335 Relevant Treatment Dose (Mild Renal Impairment)|"Capsule for oral administration
estimated glomerular filtration rate 60-89 mL/min/1.73m2"
146752|NCT01580306|E1|Reported Event|BI 201335 Relevant Treatment Dose (Normal Renal Function)|"Capsule for oral administration
estimated glomerular filtration rate >= 90 mL/min/1.73m2"
146753|NCT01580098|B3|Baseline|Total|Total of all reporting groups
146838|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146892|NCT01579747|O1|Outcome|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
146754|NCT01580098|B2|Baseline|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.
Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurses are measuring and entering the vital parameters of the patients.
Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.
No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.
Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
146755|NCT01580098|B1|Baseline|Control Group|treatment as usual
146756|NCT01580098|P3|Participant Flow|Nurse-monitoring for Patients With Diabetes Mellitus Type 2|"nurse-monitoring for patients with Diabetes Mellitus
Nurses are entering vital parameters of the patient with mobile devices"
146757|NCT01580098|P2|Participant Flow|Self-monitoring for Patients With Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.
Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital."
146758|NCT01580098|P1|Participant Flow|Control Group|treatment as usual
146759|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.
Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurses are measuring and entering the vital parameters of the patients.
Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.
No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.
Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
146760|NCT01580098|O1|Outcome|Control Group|treatment as usual
146761|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.
Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurses are measuring and entering the vital parameters of the patients.
Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.
No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.
Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
146762|NCT01580098|O1|Outcome|Control Group|treatment as usual
146763|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.
Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurses are measuring and entering the vital parameters of the patients.
Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.
No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.
Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
146764|NCT01580098|O1|Outcome|Control Group|treatment as usual
146765|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.
Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurses are measuring and entering the vital parameters of the patients.
Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.
No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.
Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
146766|NCT01580098|O1|Outcome|Control Group|treatment as usual
146767|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.
Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurses are measuring and entering the vital parameters of the patients.
Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.
No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.
Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
146768|NCT01580098|O1|Outcome|Control Group|treatment as usual
146801|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
146802|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
157860|NCT01531725|O1|Outcome|BMS Implantation|BMS implantation
146769|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.
Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurses are measuring and entering the vital parameters of the patients.
Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.
No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.
Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
146770|NCT01580098|O1|Outcome|Control Group|treatment as usual
146771|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.
Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurses are measuring and entering the vital parameters of the patients.
Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.
No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.
Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
146772|NCT01580098|O1|Outcome|Control Group|treatment as usual
146773|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters. Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurses are measuring and entering the vital parameters of the patients.
Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.
No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.
Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
146774|NCT01580098|O1|Outcome|Control Group|treatment as usual
146775|NCT01580098|E2|Reported Event|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.
Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Home nursing is also included. Nurses are measuring and entering the vital parameters of the patients.
Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.
No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.
Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
146776|NCT01580098|E1|Reported Event|Control Group|treatment as usual
146777|NCT01580072|B4|Baseline|Total|Total of all reporting groups
146778|NCT01580072|B3|Baseline|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
146779|NCT01580072|B2|Baseline|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
146780|NCT01580072|B1|Baseline|Control Group|Participants in the control group receive usual care.
146781|NCT01580072|P3|Participant Flow|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
146782|NCT01580072|P2|Participant Flow|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
146783|NCT01580072|P1|Participant Flow|Control Group|Participants in the control group receive usual care.
146784|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
146785|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
146786|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
146787|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
146788|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
146789|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
146790|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
146791|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
146792|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
146793|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
146794|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
146795|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
146796|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
146797|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
146798|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
146799|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
146800|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
146803|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
146804|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
146805|NCT01580072|E3|Reported Event|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
146806|NCT01580072|E2|Reported Event|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
146807|NCT01580072|E1|Reported Event|Control Group|Participants in the control group receive usual care.
146808|NCT01580020|B3|Baseline|Total|Total of all reporting groups
146809|NCT01580020|B2|Baseline|Dexamethasone|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
146810|NCT01580020|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
150709|NCT01564407|P2|Participant Flow|Vehicle Only|Vehicle only (0.5 ml of solution)
146811|NCT01580020|P4|Participant Flow|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
146812|NCT01580020|P3|Participant Flow|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally
146813|NCT01580020|P2|Participant Flow|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
146814|NCT01580020|P1|Participant Flow|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146815|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
146816|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146817|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
146818|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146819|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
146820|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146821|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
146822|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146823|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
146824|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146825|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
146826|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146827|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
146828|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146829|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
146830|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146831|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
146832|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146882|NCT01579916|E2|Reported Event|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
157861|NCT01531725|E1|Reported Event|BMS Implantation|BMS implantation
146833|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
146834|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146835|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
146836|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146837|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
154338|NCT01545700|O13|Outcome|Dexamethasone 8 mg 0-4 Hours-2 Hours|
146839|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
146840|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146841|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
146842|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146843|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
146844|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146845|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
146846|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146847|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
146848|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146849|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
146850|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146851|NCT01580020|E4|Reported Event|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
146852|NCT01580020|E3|Reported Event|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146853|NCT01580020|E2|Reported Event|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
146854|NCT01580020|E1|Reported Event|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
146855|NCT01579916|B3|Baseline|TOTAL|Total of all reporting groups
146856|NCT01579916|B2|Baseline|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146857|NCT01579916|B1|Baseline|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146858|NCT01579916|P2|Participant Flow|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146859|NCT01579916|P1|Participant Flow|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146860|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
147891|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
146861|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146862|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146863|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146864|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146891|NCT01579747|O2|Outcome|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
146865|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146866|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146867|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146868|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146869|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146870|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146871|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146872|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146873|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146874|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146875|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146876|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146877|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146878|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146879|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146880|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
146881|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
147185|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
146883|NCT01579916|E1|Reported Event|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
146884|NCT01579747|B3|Baseline|Total|Total of all reporting groups
146885|NCT01579747|B2|Baseline|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
146886|NCT01579747|B1|Baseline|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
146887|NCT01579747|P2|Participant Flow|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
146888|NCT01579747|P1|Participant Flow|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
146889|NCT01579747|O2|Outcome|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
146890|NCT01579747|O1|Outcome|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
146893|NCT01579747|E2|Reported Event|Ultrasound Guided Sciatic Nerve Block|Time taken to complete a sciatic nerve block via the lateral popliteal approach when using an ultrasound
146894|NCT01579747|E1|Reported Event|Nerve Stimulation Sciatic Nerve Block|Time taken to complete a sciatic nerve block via the lateral popliteal approach using nerve stimulation
146895|NCT01579669|B3|Baseline|Total|Total of all reporting groups
146896|NCT01579669|B2|Baseline|Primary Care Providers|Primary care providers taking care of autistic adults participating in this study
146897|NCT01579669|B1|Baseline|Autistic Adults|Adults on the autism spectrum
146898|NCT01579669|P2|Participant Flow|Primary Care Providers|Participants' primary care providers
146899|NCT01579669|P1|Participant Flow|Autistic Adults|Adults on the autism spectrum
146900|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
146901|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
146902|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
146903|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
146904|NCT01579669|O1|Outcome|Primary Care Providers|Participants' primary care providers
146905|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
146906|NCT01579669|E2|Reported Event|Primary Care Providers|Primary care providers of autistic adults participating in the study.
146907|NCT01579669|E1|Reported Event|Autistic Adults|Adults on the autism spectrum
146908|NCT01579578|B3|Baseline|Total|Total of all reporting groups
146909|NCT01579578|B2|Baseline|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146910|NCT01579578|B1|Baseline|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146911|NCT01579578|P2|Participant Flow|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146912|NCT01579578|P1|Participant Flow|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146913|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146914|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146915|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146916|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146917|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146918|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146919|NCT01579578|E2|Reported Event|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146920|NCT01579578|E1|Reported Event|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
146921|NCT01579565|B3|Baseline|Total|Total of all reporting groups
146922|NCT01579565|B2|Baseline|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
147186|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
146923|NCT01579565|B1|Baseline|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146924|NCT01579565|P2|Participant Flow|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146971|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
147193|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
146925|NCT01579565|P1|Participant Flow|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available balanced saline solution (BSS) through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146926|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146927|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146928|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146929|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146930|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146931|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146932|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146933|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146967|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
146968|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
146934|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146935|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146936|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146937|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146938|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146939|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146940|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146941|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146942|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146943|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146944|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146945|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
157862|NCT01531387|B3|Baseline|Total|Total of all reporting groups
146946|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146972|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
146973|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
150712|NCT01564407|O4|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
146947|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146948|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146949|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146950|NCT01579565|E2|Reported Event|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146951|NCT01579565|E1|Reported Event|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
146952|NCT01579474|B7|Baseline|Total|Total of all reporting groups
146953|NCT01579474|B6|Baseline|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
146954|NCT01579474|B5|Baseline|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
146955|NCT01579474|B4|Baseline|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
146956|NCT01579474|B3|Baseline|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
146957|NCT01579474|B2|Baseline|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146958|NCT01579474|B1|Baseline|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146959|NCT01579474|P6|Participant Flow|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
146960|NCT01579474|P5|Participant Flow|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
146961|NCT01579474|P4|Participant Flow|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
146962|NCT01579474|P3|Participant Flow|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
146963|NCT01579474|P2|Participant Flow|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146964|NCT01579474|P1|Participant Flow|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily (q.d.) for 12 or 24 weeks combined with pegylated interferon alfa-2b and ribavirin (PegIFNα-2b/RBV) for 24 weeks in treatment-naive patients.
146965|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
146966|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
146969|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146970|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
151689|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
146974|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
146975|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146976|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146977|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
146978|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
146979|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
146980|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
146981|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146982|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146983|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
146984|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
146985|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
146986|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
146987|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146988|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146989|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
146990|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
146991|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
146992|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
146993|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146994|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
146995|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
146996|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
146997|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
147892|NCT01576055|E2|Reported Event|BARD LifeStent|BARD LifeStent: Implant
146998|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
146999|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147000|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147001|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
147002|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
147003|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
147004|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
147005|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147006|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147007|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
147008|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
147009|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
147010|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
147011|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147012|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147013|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
147014|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
147015|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
147016|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
147017|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147018|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147019|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
147020|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
147021|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
147022|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
147023|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147024|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147025|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
147026|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
147893|NCT01576055|E1|Reported Event|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
147027|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
147028|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined withPegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
147029|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147030|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147071|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
147031|NCT01579474|O3|Outcome|Faldaprevir 240 mg q.d - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
147032|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147033|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
147034|NCT01579474|E3|Reported Event|Faldaprevir 240 mg q.d - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
147035|NCT01579474|E2|Reported Event|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
147036|NCT01579474|E1|Reported Event|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
147037|NCT01579305|B3|Baseline|Total|Total of all reporting groups
147038|NCT01579305|B2|Baseline|Subjects Randomized to Receive Restylane-L®|
147039|NCT01579305|B1|Baseline|Subjects Randomized to Receive VOLBELLA®|
147040|NCT01579305|P2|Participant Flow|Subjects Randomized to Receive Restylane-L®|
147041|NCT01579305|P1|Participant Flow|Subject Randomized to Receive VOLBELLA®|
147042|NCT01579305|O2|Outcome|Subjects Randomized to Receive Restylane-L® and Treated|
147043|NCT01579305|O1|Outcome|Subjects Randomized to Receive VOLBELLA® and Treated|
147044|NCT01579305|E2|Reported Event|Subjects Treated With Restylane-L®|
147045|NCT01579305|E1|Reported Event|Subjects Treated With VOLBELLA®|
147046|NCT01579084|B11|Baseline|Total|Total of all reporting groups
147047|NCT01579084|B10|Baseline|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
147048|NCT01579084|B9|Baseline|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
147049|NCT01579084|B8|Baseline|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
147050|NCT01579084|B7|Baseline|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
147051|NCT01579084|B6|Baseline|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
147052|NCT01579084|B5|Baseline|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
147053|NCT01579084|B4|Baseline|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
147054|NCT01579084|B3|Baseline|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
147055|NCT01579084|B2|Baseline|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
147056|NCT01579084|B1|Baseline|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
147057|NCT01579084|P10|Participant Flow|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
147058|NCT01579084|P9|Participant Flow|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
147059|NCT01579084|P8|Participant Flow|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
147060|NCT01579084|P7|Participant Flow|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
147061|NCT01579084|P6|Participant Flow|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
147062|NCT01579084|P5|Participant Flow|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
147063|NCT01579084|P4|Participant Flow|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
147064|NCT01579084|P3|Participant Flow|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
147065|NCT01579084|P2|Participant Flow|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
147066|NCT01579084|P1|Participant Flow|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
147067|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
147068|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
147069|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
147070|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
147194|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147072|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
147073|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
147074|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
147075|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
147076|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
147077|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
147078|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
147079|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
147080|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
147081|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
147082|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
147083|NCT01579084|E10|Reported Event|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
147084|NCT01579084|E9|Reported Event|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
147085|NCT01579084|E8|Reported Event|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
147086|NCT01579084|E7|Reported Event|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
147087|NCT01579084|E6|Reported Event|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
147088|NCT01579084|E5|Reported Event|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
147089|NCT01579084|E4|Reported Event|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
147090|NCT01579084|E3|Reported Event|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
147091|NCT01579084|E2|Reported Event|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
147092|NCT01579084|E1|Reported Event|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
147093|NCT01579045|B1|Baseline|Overall Subjects|All subjects who were enrolled, and completed the study.
147094|NCT01579045|P1|Participant Flow|All Subjects|All subjects who were enrolled.
147095|NCT01579045|O5|Outcome|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147096|NCT01579045|O4|Outcome|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147097|NCT01579045|O3|Outcome|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147098|NCT01579045|O2|Outcome|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147894|NCT01576042|B3|Baseline|Total|Total of all reporting groups
147099|NCT01579045|O1|Outcome|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147100|NCT01579045|O5|Outcome|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147149|NCT01578993|B1|Baseline|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
147101|NCT01579045|O4|Outcome|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147102|NCT01579045|O3|Outcome|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147103|NCT01579045|O2|Outcome|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147104|NCT01579045|O1|Outcome|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147105|NCT01579045|E5|Reported Event|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147106|NCT01579045|E4|Reported Event|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147107|NCT01579045|E3|Reported Event|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147108|NCT01579045|E2|Reported Event|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147109|NCT01579045|E1|Reported Event|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
147110|NCT01579006|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147111|NCT01579006|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), who have had an inadequate response (or were intolerant) to treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147112|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147113|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147114|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147115|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147184|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147116|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147150|NCT01578993|P1|Participant Flow|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
147117|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147118|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147119|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147120|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147121|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147122|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147123|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147124|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147125|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147126|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147127|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147128|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147129|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147130|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147131|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147132|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147133|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147134|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147135|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147136|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147137|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147138|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147139|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147140|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147141|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147142|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147143|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147144|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147145|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147146|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147147|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
147148|NCT01579006|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who had been receiving TCZ in the past and in whom the attending physician decided to start treatment with TCZ at the time of recruitment (according to the local label) were observed for 6 months.
151819|NCT01559311|O2|Outcome|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
147151|NCT01578993|O1|Outcome|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
147152|NCT01578993|E1|Reported Event|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
147153|NCT01578980|B1|Baseline|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity
Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
147154|NCT01578980|P1|Participant Flow|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity
Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
147155|NCT01578980|O1|Outcome|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity
Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.
42 hours total: 14 hours in open-loop 28 hours in closed-loop"
147156|NCT01578980|O1|Outcome|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity
Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.
42 hours total: 14 hours in open-loop 28 hours in closed-loop"
147157|NCT01578980|E1|Reported Event|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity
Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
147158|NCT01578850|B3|Baseline|Total|Total of all reporting groups
147159|NCT01578850|B2|Baseline|Placebo|Participants were randomized to receive PBO 50 mg QW with MTX (with or without other DMARDs).
147160|NCT01578850|B1|Baseline|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147161|NCT01578850|P3|Participant Flow|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147162|NCT01578850|P2|Participant Flow|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147163|NCT01578850|P1|Participant Flow|Open-Label Treatment|Participants in open-label treatment received Etanercept (ETN) 50 milligram (mg) once a week (QW) with MTX (with or without other DMARDs).
147164|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147165|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147166|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147167|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147168|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147169|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147170|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147171|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147172|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147173|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147174|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147175|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147176|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147177|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147178|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147179|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147180|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147181|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147182|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147183|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
148979|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
147187|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147188|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147189|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147190|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147191|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147192|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147195|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147196|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147197|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147198|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147199|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147200|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147201|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147202|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147203|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147204|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
147205|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147206|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147207|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147208|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147209|NCT01578850|E3|Reported Event|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
147210|NCT01578850|E2|Reported Event|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
147211|NCT01578850|E1|Reported Event|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg with MTX (with or without other DMARDs).
147212|NCT01578785|B3|Baseline|Total|Total of all reporting groups
147213|NCT01578785|B2|Baseline|GA 20 mg/0.5 ml|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
147214|NCT01578785|B1|Baseline|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
147215|NCT01578785|P2|Participant Flow|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
147216|NCT01578785|P1|Participant Flow|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
147217|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
147218|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
147219|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
147220|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
147221|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
147222|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
147223|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
147224|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
147225|NCT01578785|E2|Reported Event|Ga 20 mg/0.5 ml|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
147226|NCT01578785|E1|Reported Event|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
147227|NCT01578772|B1|Baseline|Telmisartan|"Open label
Telmisartan: 80mg tablets po daily for 6 weeks"
147228|NCT01578772|P1|Participant Flow|Telmisartan|"Open label
Telmisartan: 80mg tablets po daily for 6 weeks"
147229|NCT01578772|O2|Outcome|Week 6|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
147230|NCT01578772|O1|Outcome|Baseline (Week 0)|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
147231|NCT01578772|O2|Outcome|Week 6|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
147232|NCT01578772|O1|Outcome|Baseline (Week 0)|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
147233|NCT01578772|E1|Reported Event|Telmisartan|"Open label
Telmisartan: 80mg tablets po daily for 6 weeks"
147234|NCT01578707|B3|Baseline|Total|Total of all reporting groups
148035|NCT01573910|B1|Baseline|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
147235|NCT01578707|B2|Baseline|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor
ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
147236|NCT01578707|B1|Baseline|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody
ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.
Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
147237|NCT01578707|P2|Participant Flow|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor
ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
147238|NCT01578707|P1|Participant Flow|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody
ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.
Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
147239|NCT01578707|O2|Outcome|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor
ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
147240|NCT01578707|O1|Outcome|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody
ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.
Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
147241|NCT01578707|O2|Outcome|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor
ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
147242|NCT01578707|O1|Outcome|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody
ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.
Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
147243|NCT01578707|E2|Reported Event|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor
ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
147244|NCT01578707|E1|Reported Event|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody
ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.
Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
147245|NCT01578330|B1|Baseline|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
147246|NCT01578330|P1|Participant Flow|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
147247|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
147248|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
147249|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
147250|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
147251|NCT01578330|E1|Reported Event|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
147252|NCT01578187|B1|Baseline|Hair2Go Device|The subjects who participated in the label comprehension phase, of them most participated in the usability phase. The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM)test.
147253|NCT01578187|P1|Participant Flow|Hair2Go Device|"This group included subjects who participated in the label comprehension phase. From these subjects, 48 subjects self-included in the usability phase (no contraindications) and chose to use the device for 1 treatment.
The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM) test."
147254|NCT01578187|O2|Outcome|Usability - Non Critical Error|Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event.
147255|NCT01578187|O1|Outcome|Usability - Critical Error|Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence
147256|NCT01578187|O1|Outcome|Label Comprehension Group|Subjects that participated in the label comprehension phase of the study
147257|NCT01578187|E1|Reported Event|Hair2Go (Me) Device|The subjects who participated in the label comprehension phase; the majority of whom participated in the usability phase. The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM)test.
147258|NCT01578044|B3|Baseline|Total|Total of all reporting groups
147259|NCT01578044|B2|Baseline|Usual Care Group|"Usual care
Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.
Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study."
147260|NCT01578044|B1|Baseline|Intervention Group|"Patients who are randomized to the intervention group will receive the following:
Patient education: Patients will receive information on dabigatran, apixaban, and rivaroxaban, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.
Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.
Pharmacy follow-up: If the anticoagulant has not been refilled, the pharmacy staff will contact the patient to assess reasons the patient has not refilled the medication."
147261|NCT01578044|P2|Participant Flow|Usual Care|"Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.
Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study."
147310|NCT01577758|O2|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
147262|NCT01578044|P1|Participant Flow|Intervention Group|"Intervention patients will receive the following:
Patient education: All patients will receive information on their oral anticoagulant, including risks, benefits, and potential side effects. Intervention patients will receive additional materials at the beginning of the study through the mail.
Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.
Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
147263|NCT01578044|O2|Outcome|Usual Care Group|All usual care patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Additionally, following their time in the study, the usual care patients will receive the additional educational materials the usual care received.
148042|NCT01573910|E2|Reported Event|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
147264|NCT01578044|O1|Outcome|Intervention Group|"Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.
Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.
Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
147265|NCT01578044|E2|Reported Event|Usual Care Group|"Usual care
All patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Also, following their enrollment in the study will receive the additional educational materials given to the intervention group during their time in the study."
147266|NCT01578044|E1|Reported Event|Intervention Group|"Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.
Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.
Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
147267|NCT01578031|B5|Baseline|Total|Total of all reporting groups
147268|NCT01578031|B4|Baseline|Non-obese Subjects Without OSA|"Control.
Usual Care: Usual care."
147269|NCT01578031|B3|Baseline|Obese Subjects Without OSA|"Control.
Usual Care: Usual care."
147270|NCT01578031|B2|Baseline|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
147271|NCT01578031|B1|Baseline|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
147272|NCT01578031|P4|Participant Flow|Non-obese Subjects Without OSA|"Control.
Usual Care: Usual care."
147273|NCT01578031|P3|Participant Flow|Obese Subjects Without OSA|"Control.
Usual Care: Usual care."
147274|NCT01578031|P2|Participant Flow|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
147275|NCT01578031|P1|Participant Flow|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
147276|NCT01578031|O2|Outcome|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
147277|NCT01578031|O1|Outcome|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
147278|NCT01578031|E4|Reported Event|Non-obese Patients Without Sleep Apnea|Control Non-obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index < 15
147279|NCT01578031|E3|Reported Event|Obese Patients Without Sleep Apnea|Control Obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index < 15
147280|NCT01578031|E2|Reported Event|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
147281|NCT01578031|E1|Reported Event|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
147311|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
148980|NCT01570309|O2|Outcome|Sugar Pill|Matching Placebo
147282|NCT01577966|B1|Baseline|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety
Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
147283|NCT01577966|P1|Participant Flow|Sulfasalazine|Sulfasalazine
147315|NCT01577758|O4|Outcome|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
148043|NCT01573910|E1|Reported Event|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
147284|NCT01577966|O1|Outcome|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety
Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
147285|NCT01577966|E1|Reported Event|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety
Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
147286|NCT01577758|B1|Baseline|All Participants|All participants who participated in the Dose Escalation and mCRC Expansion Phases.
147287|NCT01577758|P8|Participant Flow|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
147288|NCT01577758|P7|Participant Flow|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147289|NCT01577758|P6|Participant Flow|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147290|NCT01577758|P5|Participant Flow|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147291|NCT01577758|P4|Participant Flow|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147292|NCT01577758|P3|Participant Flow|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147293|NCT01577758|P2|Participant Flow|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147294|NCT01577758|P1|Participant Flow|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147295|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147296|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147297|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147298|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147299|NCT01577758|O8|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
147300|NCT01577758|O7|Outcome|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147301|NCT01577758|O6|Outcome|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147302|NCT01577758|O5|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147303|NCT01577758|O4|Outcome|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147304|NCT01577758|O3|Outcome|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147305|NCT01577758|O2|Outcome|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147306|NCT01577758|O1|Outcome|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147307|NCT01577758|O2|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
147308|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
147309|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
147312|NCT01577758|O7|Outcome|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147313|NCT01577758|O6|Outcome|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147314|NCT01577758|O5|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147358|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147316|NCT01577758|O3|Outcome|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147317|NCT01577758|O2|Outcome|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147318|NCT01577758|O1|Outcome|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147319|NCT01577758|E7|Reported Event|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147320|NCT01577758|E6|Reported Event|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147321|NCT01577758|E5|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147322|NCT01577758|E4|Reported Event|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147323|NCT01577758|E3|Reported Event|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147324|NCT01577758|E2|Reported Event|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147325|NCT01577758|E1|Reported Event|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
147326|NCT01577745|B7|Baseline|Total|Total of all reporting groups
147327|NCT01577745|B6|Baseline|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
147328|NCT01577745|B5|Baseline|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147329|NCT01577745|B4|Baseline|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147330|NCT01577745|B3|Baseline|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147331|NCT01577745|B2|Baseline|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147332|NCT01577745|B1|Baseline|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147333|NCT01577745|P6|Participant Flow|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
147334|NCT01577745|P5|Participant Flow|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147335|NCT01577745|P4|Participant Flow|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147336|NCT01577745|P3|Participant Flow|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147337|NCT01577745|P2|Participant Flow|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147338|NCT01577745|P1|Participant Flow|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute intravenous (IV) infusion on Day 1 of each 21-day cycle.
147339|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147340|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147341|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147342|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147343|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147344|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147345|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147346|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147347|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147348|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147349|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147350|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147351|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147352|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
158070|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
147353|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147354|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147355|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147356|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147357|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147359|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147360|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147361|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147362|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147363|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147364|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147365|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147366|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147367|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147368|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147369|NCT01577745|O6|Outcome|MMEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147370|NCT01577745|O5|Outcome|MMEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147371|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle..
147372|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147373|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147374|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147375|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147376|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147377|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147378|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147379|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147380|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147381|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147382|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147383|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147384|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147385|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147386|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147387|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147388|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147389|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147390|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147391|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147392|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147393|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147394|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147395|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147396|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147397|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147398|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147399|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147400|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147401|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147402|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147403|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147404|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147405|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147406|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147407|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147408|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147409|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147410|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147411|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147412|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147413|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147414|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147415|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147416|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147417|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147418|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147419|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147420|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147421|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147422|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147423|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147424|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147425|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147426|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147427|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147428|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147429|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147430|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147431|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147432|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147433|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147434|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147435|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147436|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147437|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147438|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147439|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147440|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147441|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
147442|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147443|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147444|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147445|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147446|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147447|NCT01577745|O1|Outcome|MEDI0639|Participants received MEDI0639, in dose escalation phase starting from dose level 1 to 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147448|NCT01577745|E6|Reported Event|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
147449|NCT01577745|E5|Reported Event|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147450|NCT01577745|E4|Reported Event|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147451|NCT01577745|E3|Reported Event|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147452|NCT01577745|E2|Reported Event|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147453|NCT01577745|E1|Reported Event|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
147454|NCT01577732|B1|Baseline|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
147455|NCT01577732|P1|Participant Flow|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
147456|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
147457|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
147458|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
147459|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
147460|NCT01577732|E1|Reported Event|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
147461|NCT01577706|B1|Baseline|All Study Participants|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day
Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
147462|NCT01577706|P3|Participant Flow|Placebo, Dextroamphetamine, Alprazolam Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Placebo: single-dose, 1-day"
147463|NCT01577706|P2|Participant Flow|Alprazolam, Dextroamphetamine, Placebo Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Placebo: single-dose, 1-day"
147464|NCT01577706|P1|Participant Flow|Dextroamphetamine, Alprazolam, Placebo Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Placebo: single-dose, 1-day"
147465|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
147466|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
147467|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Placebo: single-dose, 1-day"
147468|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
147469|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
147470|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Placebo: single-dose, 1-day"
147471|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
147472|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
147473|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Placebo: single-dose, 1-day"
147474|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
147475|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
147476|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Placebo: single-dose, 1-day"
147477|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
147560|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147478|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
147479|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Placebo: single-dose, 1-day"
147480|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
147481|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
147482|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Placebo: single-dose, 1-day"
148044|NCT01575054|B3|Baseline|Total|Total of all reporting groups
147483|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
147484|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
147485|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Placebo: single-dose, 1-day"
147486|NCT01577706|E3|Reported Event|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Placebo, single-dose, 1-day"
147487|NCT01577706|E2|Reported Event|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
147488|NCT01577706|E1|Reported Event|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning
Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
147489|NCT01577628|B3|Baseline|Total|Total of all reporting groups
147490|NCT01577628|B2|Baseline|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147491|NCT01577628|B1|Baseline|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147492|NCT01577628|P3|Participant Flow|Screen Only|Subject was not randomized to either treatment prior to study termination.
147493|NCT01577628|P2|Participant Flow|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147494|NCT01577628|P1|Participant Flow|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147495|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147496|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147497|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147498|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147499|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147500|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147501|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147502|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147503|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147504|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147505|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147506|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147507|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147508|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147509|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147510|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147511|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147512|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147513|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147514|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147515|NCT01577628|E2|Reported Event|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
147516|NCT01577628|E1|Reported Event|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
147517|NCT01577381|B5|Baseline|Total|Total of all reporting groups
147518|NCT01577381|B4|Baseline|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147519|NCT01577381|B3|Baseline|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147520|NCT01577381|B2|Baseline|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147521|NCT01577381|B1|Baseline|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147522|NCT01577381|P4|Participant Flow|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147523|NCT01577381|P3|Participant Flow|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147524|NCT01577381|P2|Participant Flow|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147525|NCT01577381|P1|Participant Flow|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147526|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147527|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147528|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147529|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147530|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147531|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147532|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147533|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147534|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147535|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147536|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147537|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147538|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147539|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147540|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147541|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147542|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147543|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147544|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147545|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147546|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147547|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147548|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147549|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147550|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147551|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147552|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147553|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147554|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147555|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147556|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147557|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147558|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147559|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
148981|NCT01570309|O1|Outcome|Active|Ergocalciferal 50,000 U qweekly x 12 weeks
147561|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147562|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147563|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147564|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147565|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147566|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147567|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147568|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147569|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147570|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147571|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147572|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147573|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147574|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147575|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147576|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147577|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147578|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147579|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147580|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147581|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147582|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147583|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147584|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147585|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147586|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147587|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147588|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147589|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147590|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147591|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147592|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147593|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147594|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147595|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147596|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147597|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147598|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147599|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147600|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147601|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
148982|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
147602|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147603|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147604|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147605|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147606|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147607|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147608|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147609|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147610|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147611|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147612|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147613|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147614|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147615|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147616|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147617|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147618|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147619|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147620|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147621|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147622|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147623|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147624|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147625|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147626|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147627|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147628|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147629|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147630|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147631|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147632|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147633|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147634|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147635|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147636|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147637|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147638|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147639|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147640|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147641|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147642|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147643|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147644|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147645|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147646|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147647|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
148187|NCT01574183|P1|Participant Flow|Vilazodone|"Flexible dose up to 40 mg capsule daily
Vilazodone: 40 mg capsule daily"
147648|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147649|NCT01577381|E4|Reported Event|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
147650|NCT01577381|E3|Reported Event|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147651|NCT01577381|E2|Reported Event|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
147652|NCT01577381|E1|Reported Event|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
147653|NCT01577329|B3|Baseline|Total|Total of all reporting groups
147654|NCT01577329|B2|Baseline|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
147655|NCT01577329|B1|Baseline|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.
Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
147656|NCT01577329|P2|Participant Flow|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
147657|NCT01577329|P1|Participant Flow|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.
Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
147658|NCT01577329|O2|Outcome|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
147659|NCT01577329|O1|Outcome|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.
Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
147660|NCT01577329|E2|Reported Event|Wait List|Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
147661|NCT01577329|E1|Reported Event|Mindfulness Meditation Class|"Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.
Mindfulness meditation: Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned."
147662|NCT01577186|B1|Baseline|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
147663|NCT01577186|P1|Participant Flow|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
147664|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
147665|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
147666|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
147667|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
147668|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
147669|NCT01577186|E1|Reported Event|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
147670|NCT01577160|B1|Baseline|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
147671|NCT01577160|P1|Participant Flow|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s Clinical Global Impression - Improvement (CGI-I) score.
147672|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
148036|NCT01573910|P2|Participant Flow|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
147673|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
147674|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
148188|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily
Placebo: 40 mg capsule daily"
147675|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
147676|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
147677|NCT01577160|E1|Reported Event|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
147678|NCT01577108|B3|Baseline|Total|Total of all reporting groups
147679|NCT01577108|B2|Baseline|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days
GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
147680|NCT01577108|B1|Baseline|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days
GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
147681|NCT01577108|P2|Participant Flow|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days
GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
147682|NCT01577108|P1|Participant Flow|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days
GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
147683|NCT01577108|O2|Outcome|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days
GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days
Number of GBS-Positive pregnant women who became GBS-Negative at childbirth is 9 in the probiotic group (18.0%)."
147684|NCT01577108|O1|Outcome|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days
GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days
Number of GBS-Positive pregnant women who became GBS-Negative at childbirth is 21 in the probiotic group (42.9%)."
147685|NCT01577108|E2|Reported Event|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days
GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
147686|NCT01577108|E1|Reported Event|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days
GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
147687|NCT01576952|B3|Baseline|Total|Total of all reporting groups
147688|NCT01576952|B2|Baseline|Vehicle|DuraSite vehicle dosed BID
147689|NCT01576952|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite dosed BID
147690|NCT01576952|P2|Participant Flow|Vehicle|DuraSite vehicle dosed BID
147691|NCT01576952|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite dosed BID
147692|NCT01576952|O2|Outcome|Vehicle|DuraSite vehicle dosed BID
147693|NCT01576952|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite dosed BID
147694|NCT01576952|E2|Reported Event|Vehicle|DuraSite vehicle dosed BID
147695|NCT01576952|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite dosed BID
147696|NCT01576939|B1|Baseline|Intensity Modulated RT Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.
intensity modulated radiotherapy treatment"
147697|NCT01576939|P1|Participant Flow|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.
intensity modulated radiotherapy treatment"
147698|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.
intensity modulated radiotherapy treatment"
147699|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.
intensity modulated radiotherapy treatment"
147700|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.
intensity modulated radiotherapy treatment"
147701|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.
intensity modulated radiotherapy treatment"
147702|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.
intensity modulated radiotherapy treatment"
147703|NCT01576939|E1|Reported Event|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.
intensity modulated radiotherapy treatment"
147704|NCT01576809|B1|Baseline|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
147705|NCT01576809|P1|Participant Flow|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
147706|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
147707|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
147708|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
147925|NCT01575912|O2|Outcome|Group of Subjects With Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
147709|NCT01576809|E1|Reported Event|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
147710|NCT01576718|B7|Baseline|Total|Total of all reporting groups
147929|NCT01575912|E1|Reported Event|Group of Subjects With Schizophrenia SC|subjects presenting a diagnosis of schizophrenia according to the DSM IV TR and submitted to experimental pain tests
147711|NCT01576718|B6|Baseline|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147712|NCT01576718|B5|Baseline|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147713|NCT01576718|B4|Baseline|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147714|NCT01576718|B3|Baseline|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147715|NCT01576718|B2|Baseline|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147716|NCT01576718|B1|Baseline|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147717|NCT01576718|P7|Participant Flow|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147718|NCT01576718|P6|Participant Flow|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147719|NCT01576718|P5|Participant Flow|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147720|NCT01576718|P4|Participant Flow|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147721|NCT01576718|P3|Participant Flow|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147722|NCT01576718|P2|Participant Flow|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147723|NCT01576718|P1|Participant Flow|Placebo MDPI (Run-In)|Upon enrollment, participants used current asthma medications and 1 inhalation of placebo multidose dry powder inhaler (MDPI), single-blind, twice daily for 14-day (±2 days).
147724|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147725|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147830|NCT01576367|E1|Reported Event|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
147831|NCT01576341|B1|Baseline|HX575, Safety Population|The Study was designed as single arm study with HX575 tested as investigational medicinal product. The safety population (SAF) consisted of all patients that received at least one dose of study drug. 417 patients enrolled, 416 treated. Group includes ESA-naïve patients and patients on ESA-maintenance therapy.
147726|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147727|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147728|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147729|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147730|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147731|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147732|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147733|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147734|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147735|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147736|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147737|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147738|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147739|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147740|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147741|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147742|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147743|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147744|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147745|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147746|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147747|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147748|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147749|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147750|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147751|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147752|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147753|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147754|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147755|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147756|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147757|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
158071|NCT01530334|E1|Reported Event|Gefitinib|250 mg/die, oral
147758|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147759|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147760|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147761|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147762|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147763|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147764|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147765|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147766|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147767|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147768|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147769|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147770|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147771|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147772|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147773|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
158072|NCT01530243|B5|Baseline|Total|Total of all reporting groups
147774|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147775|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147776|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147777|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147778|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147779|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147780|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147781|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147782|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147783|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147784|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147785|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147786|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147787|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147788|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147789|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147790|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147791|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147792|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147793|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147794|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147795|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147796|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147797|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147798|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147799|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147800|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147801|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147802|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147803|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147804|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147805|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
160148|NCT01520922|B3|Baseline|Total|Total of all reporting groups
147806|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147807|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147808|NCT01576718|E6|Reported Event|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147809|NCT01576718|E5|Reported Event|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147810|NCT01576718|E4|Reported Event|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147811|NCT01576718|E3|Reported Event|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147812|NCT01576718|E2|Reported Event|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147813|NCT01576718|E1|Reported Event|Flovent Diskus 250 mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
147814|NCT01576471|B3|Baseline|Total|Total of all reporting groups
147815|NCT01576471|B2|Baseline|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
147816|NCT01576471|B1|Baseline|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
147817|NCT01576471|P2|Participant Flow|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
147818|NCT01576471|P1|Participant Flow|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
147819|NCT01576471|O2|Outcome|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
147820|NCT01576471|O1|Outcome|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
147821|NCT01576471|E2|Reported Event|TSO 7500|Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
147822|NCT01576471|E1|Reported Event|Placebo|Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
147823|NCT01576367|B1|Baseline|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
147824|NCT01576367|P1|Participant Flow|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
147825|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
147826|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
147827|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
147828|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
147829|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
147832|NCT01576341|P1|Participant Flow|HX575, Safety Population|In the single arm study, HX575 was tested as investigational medicinal product. The single arm includes ESA-naïve patients and patients on ESA-maintenance therapy.
147833|NCT01576341|O3|Outcome|HX575|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL.
147834|NCT01576341|O2|Outcome|HX575 - ESA Maintenance|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL. At study start patients were either ESA (Erythropoiesis Stimulating Agent) naive or on ESA maintenance treatment. This group only contains patients that were on ESA maintenance treatment at study start, e.g. did receive at least one dose of commercial ESA treatment within 2 months prior to first screening visit.
147835|NCT01576341|O1|Outcome|HX575 - ESA Naive|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL. At study start patients were either ESA (Erythropoiesis Stimulating Agent) naive or on ESA maintenance treatment. This group only contains patients that were ESA naive at study start, e.g. did not receive any ESA dose within 2 months prior to first screening visit.
147836|NCT01576341|O1|Outcome|HX575|HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL
147837|NCT01576341|E1|Reported Event|HX575, Safety Population|Study was designed as single arm study with HX575 tested as investigational medicinal product. Safety population includes ESA therapy naïve patients and ESA maintenance patients. Shown are all AEs including non-treatment related AEs.
147838|NCT01576159|B5|Baseline|Total|Total of all reporting groups
147839|NCT01576159|B4|Baseline|Control Group|Didn't participate any organized physical exercises
147840|NCT01576159|B3|Baseline|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
147841|NCT01576159|B2|Baseline|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
147842|NCT01576159|B1|Baseline|High-Impact Loading|Performed high-impact running exercise during intervention period.
147843|NCT01576159|P4|Participant Flow|Control Group|Didn't participate any organized physical exercises
147844|NCT01576159|P3|Participant Flow|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
147845|NCT01576159|P2|Participant Flow|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
147846|NCT01576159|P1|Participant Flow|High-Impact Loading|Performed high-impact running exercise during intervention period.
147847|NCT01576159|O4|Outcome|Control Group|Not Participated any organized physical exercise
147848|NCT01576159|O3|Outcome|Non-Impact Loading|Performed Non-impact swimming exercise for 12 weeks
147849|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed Moderate-impact cycling exercise for 12 weeks
147850|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise for 12 weeks
147851|NCT01576159|O4|Outcome|Control Group|Not participated any organized physical exercise
147852|NCT01576159|O3|Outcome|Non-Impact Loading|Performed non-impact swimming exercise during intervention period.
147853|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed Moderate-impact cycling exercise during intervention period.
147854|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise during intervention period.
147855|NCT01576159|O4|Outcome|Control Group|Didn't participate any organized physical exercises
147856|NCT01576159|O3|Outcome|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
147857|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
147858|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise during intervention period.
147859|NCT01576159|E4|Reported Event|Control Group|Didn't participate any organized physical exercises
147860|NCT01576159|E3|Reported Event|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
147861|NCT01576159|E2|Reported Event|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
147862|NCT01576159|E1|Reported Event|High-Impact Loading|Performed high-impact running exercise during intervention period.
147863|NCT01576146|B1|Baseline|Etelcalcetide|Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
147864|NCT01576146|P1|Participant Flow|Etelcalcetide|Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
147865|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
147866|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
163016|NCT01510652|B3|Baseline|Total|Total of all reporting groups
147927|NCT01575912|E3|Reported Event|Group of Controls Without Psychiatric Disorder|control subjects without any psychiatric disorder and submitted to experimental pain tests
147928|NCT01575912|E2|Reported Event|Group of Subjects Presenting Major Depression MD|subjects presenting a diagnosis of major depression according to the DSM IV TR and submitted to experimental pain tests
147867|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
147868|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
147869|NCT01576146|E1|Reported Event|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
147870|NCT01576120|B3|Baseline|Total|Total of all reporting groups
147871|NCT01576120|B2|Baseline|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
147872|NCT01576120|B1|Baseline|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
147873|NCT01576120|P2|Participant Flow|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
147874|NCT01576120|P1|Participant Flow|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
147875|NCT01576120|O2|Outcome|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
147876|NCT01576120|O1|Outcome|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
147877|NCT01576120|E2|Reported Event|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
147878|NCT01576120|E1|Reported Event|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
147879|NCT01576055|B3|Baseline|Total|Total of all reporting groups
147880|NCT01576055|B2|Baseline|BARD LifeStent|BARD LifeStent: Implant
147881|NCT01576055|B1|Baseline|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
147882|NCT01576055|P2|Participant Flow|BARD LifeStent|BARD LifeStent: Implant
147883|NCT01576055|P1|Participant Flow|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
147884|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
147885|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
147886|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
147887|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
147888|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
147895|NCT01576042|B2|Baseline|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
147896|NCT01576042|B1|Baseline|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
147897|NCT01576042|P2|Participant Flow|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
147898|NCT01576042|P1|Participant Flow|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
147899|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
147900|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
147901|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
147902|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
147903|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
147904|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
147905|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
147906|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
147926|NCT01575912|O1|Outcome|Group of Subjects Presenting Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
147907|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
147908|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
147909|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
147910|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
147911|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
147912|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
147913|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
147914|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
147915|NCT01576042|E2|Reported Event|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
147916|NCT01576042|E1|Reported Event|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
147917|NCT01575912|B4|Baseline|Total|Total of all reporting groups
147918|NCT01575912|B3|Baseline|Group of Controls Without Psychiatric Disorder|subjects without any psychiatric disorder and submitted to experimental pain tests
147919|NCT01575912|B2|Baseline|Group of Subjects Presenting Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
147920|NCT01575912|B1|Baseline|Group of Subjects With Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
147921|NCT01575912|P3|Participant Flow|Group of Subjects Without Psychiatric Troubles C|subjects without any psychiatric disorder and submitted to experimental pain tests
147922|NCT01575912|P2|Participant Flow|Group of Subjects Presenting Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
147923|NCT01575912|P1|Participant Flow|Group of Subjects Presenting Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
147924|NCT01575912|O3|Outcome|Group of Subjects Without Psychiatric Troubles C|control subjects without any psychiatric disorder
147931|NCT01575899|B3|Baseline|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
147932|NCT01575899|B2|Baseline|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
147933|NCT01575899|B1|Baseline|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
147934|NCT01575899|P3|Participant Flow|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
147935|NCT01575899|P2|Participant Flow|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
147936|NCT01575899|P1|Participant Flow|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
147937|NCT01575899|O2|Outcome|Clarithromycin-Amoxicillin|Participants who are living in rural area and received 7-day clarithromycin, amoxicillin and rabeprazole for Hp eradication.
147938|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav.|Participants who are living in rural area and received 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for Hp eradication.
147939|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.
147940|NCT01575899|O2|Outcome|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
147941|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
147942|NCT01575899|E3|Reported Event|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
147943|NCT01575899|E2|Reported Event|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
147944|NCT01575899|E1|Reported Event|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
147945|NCT01575769|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147946|NCT01575769|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilograms (mg/kg) via intravenous (IV) infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147947|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147948|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147949|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147950|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147951|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147952|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147953|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147954|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147955|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147956|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147957|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147958|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147959|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147960|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147961|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147962|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147963|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147964|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147965|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147966|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147967|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
147968|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
147969|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
147970|NCT01575769|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
147971|NCT01575756|B1|Baseline|Octafibrin Followed by Haemocomplettan® P or RiaSTAPTM or Haem|Participants received Octafibrin 70 mg/kg intravenously once followed by Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once 45 days later or Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once followed by Octafibrin 70 mg/kg intravenously once 45 days later.
147972|NCT01575756|P2|Participant Flow|Haemocomplettan® P or RiaSTAPTM Followed by Octafibrin|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once followed by Octafibrin 70 mg/kg intravenously once 45 days later.
147973|NCT01575756|P1|Participant Flow|Octafibrin Followed by Haemocomplettan® P or RiaSTAPTM|Participants received Octafibrin 70 mg/kg intravenously once followed by Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once 45 days later.
147974|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
147975|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
147976|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
147977|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
147978|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
147979|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
147980|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
147981|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
147982|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
147983|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
147984|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
147985|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
147986|NCT01575756|E2|Reported Event|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
147987|NCT01575756|E1|Reported Event|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
147988|NCT01575561|B1|Baseline|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
147989|NCT01575561|P1|Participant Flow|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
147990|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
147991|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
147992|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
147993|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
147994|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
147995|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
147996|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
147997|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
147998|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
147999|NCT01575561|E1|Reported Event|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone: Lurasidone 20-80 mg taken orally once daily"
148000|NCT01575522|B1|Baseline|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.
Laboratory Biomarker Analysis: Correlative studies
Tivantinib: Given PO"
148032|NCT01575080|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
148033|NCT01573910|B3|Baseline|Total|Total of all reporting groups
148034|NCT01573910|B2|Baseline|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
148001|NCT01575522|P1|Participant Flow|Treatment (Tivantinib)|"Patients receive tivantinib 360 mg PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.
Laboratory Biomarker Analysis: Correlative studies
Tivantinib: Given PO"
148002|NCT01575522|O1|Outcome|Evaluation of c-Met Positive Circulating Tumor Cells|
148189|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily
Vilazodone: 40 mg capsule daily"
148003|NCT01575522|O1|Outcome|Evaluation of Phospho c-Met Positivity|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.
148004|NCT01575522|O1|Outcome|Evaluation of c-Met Positivity|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.
148005|NCT01575522|O1|Outcome|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.
Laboratory Biomarker Analysis: Correlative studies
Tivantinib: Given PO"
148006|NCT01575522|O1|Outcome|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.
Laboratory Biomarker Analysis: Correlative studies
Tivantinib: Given PO"
148007|NCT01575522|E1|Reported Event|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.
Laboratory Biomarker Analysis: Correlative studies
Tivantinib: Given PO"
148008|NCT01575197|B4|Baseline|Total|Total of all reporting groups
148009|NCT01575197|B3|Baseline|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
148010|NCT01575197|B2|Baseline|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
148011|NCT01575197|B1|Baseline|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
148012|NCT01575197|P3|Participant Flow|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6, 10, & 14 weeks of age.
148013|NCT01575197|P2|Participant Flow|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 10 & 14 weeks of age.
148014|NCT01575197|P1|Participant Flow|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 & 10 weeks of age.
148015|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
148016|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
148017|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
148018|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
148019|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
148020|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
148021|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
148022|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
148023|NCT01575197|E3|Reported Event|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
148024|NCT01575197|E2|Reported Event|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
148025|NCT01575197|E1|Reported Event|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
148026|NCT01575080|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
148027|NCT01575080|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
148028|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
148029|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
148030|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
148031|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
164263|NCT01504854|B3|Baseline|Total|Total of all reporting groups
148037|NCT01573910|P1|Participant Flow|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
148038|NCT01573910|O2|Outcome|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
148039|NCT01573910|O1|Outcome|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
148040|NCT01573910|O2|Outcome|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
148041|NCT01573910|O1|Outcome|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
148045|NCT01575054|B2|Baseline|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148046|NCT01575054|B1|Baseline|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148047|NCT01575054|P2|Participant Flow|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148048|NCT01575054|P1|Participant Flow|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148049|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148050|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148051|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148052|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148053|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148054|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148055|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148056|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148057|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148058|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
148059|NCT01575054|E2|Reported Event|Normal Saline (Placebo)|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.
148190|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily
Placebo: 40 mg capsule daily"
154339|NCT01545700|O12|Outcome|Dexamethasone 8 mg 0-4 Hours-1 Hour|
148060|NCT01575054|E1|Reported Event|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles.
148061|NCT01575028|B3|Baseline|Total|Total of all reporting groups
148062|NCT01575028|B2|Baseline|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.
Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
148063|NCT01575028|B1|Baseline|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.
Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
148064|NCT01575028|P2|Participant Flow|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.
Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
148065|NCT01575028|P1|Participant Flow|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.
Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
148066|NCT01575028|O2|Outcome|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.
Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
148067|NCT01575028|O1|Outcome|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.
Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
148068|NCT01575028|E2|Reported Event|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.
Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
148069|NCT01575028|E1|Reported Event|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.
Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
148070|NCT01574703|B5|Baseline|Total|Total of all reporting groups
148071|NCT01574703|B4|Baseline|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
148072|NCT01574703|B3|Baseline|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148073|NCT01574703|B2|Baseline|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148074|NCT01574703|B1|Baseline|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148075|NCT01574703|P4|Participant Flow|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
148076|NCT01574703|P3|Participant Flow|Nicotine Replacement Therapy (NRT) Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148077|NCT01574703|P2|Participant Flow|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148078|NCT01574703|P1|Participant Flow|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148079|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
148080|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148081|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148181|NCT01574248|E2|Reported Event|Placebo|"Subcutaneous at time 0 and 6 hours
Placebo: Subcutaneous at time 0 and 6 hours"
148082|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148083|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
154340|NCT01545700|O11|Outcome|Dexamethasone 8 mg 0-4 Hours-baseline|
148084|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148085|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148086|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148087|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
148088|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148089|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148090|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148091|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
148092|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148093|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148094|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148095|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
148096|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148097|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148098|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148099|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
148100|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148101|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148102|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148182|NCT01574248|E1|Reported Event|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
icatibant: Subcutaneous at time 0 and 6 hours"
148103|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
148104|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148105|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148106|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148107|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
148108|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148109|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148110|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148111|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
148112|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148113|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148114|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148115|NCT01574703|E4|Reported Event|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
148116|NCT01574703|E3|Reported Event|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
148117|NCT01574703|E2|Reported Event|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
148118|NCT01574703|E1|Reported Event|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
148119|NCT01574651|B3|Baseline|Total|Total of all reporting groups
148120|NCT01574651|B2|Baseline|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148121|NCT01574651|B1|Baseline|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148122|NCT01574651|P2|Participant Flow|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148123|NCT01574651|P1|Participant Flow|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148124|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148125|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148126|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148127|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148128|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148191|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily
Vilazodone: 40 mg capsule daily"
151820|NCT01559311|O1|Outcome|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
148129|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148130|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148131|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148132|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148133|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148134|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148135|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148136|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148137|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148138|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148139|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148140|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148141|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148142|NCT01574651|E2|Reported Event|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
148143|NCT01574651|E1|Reported Event|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
148144|NCT01574612|B1|Baseline|Topical Cream|xerese topical cream is the only active used in this trial
148145|NCT01574612|P1|Participant Flow|Topical Cream|"commercial product being used
acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days"
148146|NCT01574612|O1|Outcome|Topical Cream|commercial cream used
148147|NCT01574612|E1|Reported Event|Topical Cream|"commercial product being used
acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days"
148148|NCT01574326|B3|Baseline|Total|Total of all reporting groups
148149|NCT01574326|B2|Baseline|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
148150|NCT01574326|B1|Baseline|FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate TID for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 POS and 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).
148183|NCT01574183|B3|Baseline|Total|Total of all reporting groups
148184|NCT01574183|B2|Baseline|Placebo|"Flexible dose up to 40 mg capsule daily
Placebo: 40 mg capsule daily"
148185|NCT01574183|B1|Baseline|Vilazodone|"Flexible dose up to 40 mg capsule daily
Vilazodone: 40 mg capsule daily"
148186|NCT01574183|P2|Participant Flow|Placebo|"Flexible dose up to 40 mg capsule daily
Placebo: 40 mg capsule daily"
148192|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily
Placebo: up to 40 mg capsule daily"
148193|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily
Vilazodone: up to 40 mg capsule daily"
148194|NCT01574183|E2|Reported Event|Placebo|Flexible dose Placebo: up to 40 mg capsule daily
148195|NCT01574183|E1|Reported Event|Vilazodone|Flexible dose Vilazodone: up to 40 mg capsule daily
148151|NCT01574326|P2|Participant Flow|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
148152|NCT01574326|P1|Participant Flow|FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate 3 times a day (TID) for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as powder for oral suspension (POS) & 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).
148153|NCT01574326|O2|Outcome|FDP-Sevelamer Carbonate, DTP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP.
148154|NCT01574326|O1|Outcome|FDP- Placebo for Sevelamer Carbonate; DTP– Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter participants received sevelamer carbonate for 26 weeks in DTP.
148155|NCT01574326|O2|Outcome|FDP-Sevelamer Carbonate, DTP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP based on the screening BSA category.
148156|NCT01574326|O1|Outcome|FDP- Placebo for Sevelamer Carbonate; DTP– Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter, participants received sevelamer carbonate for 26 weeks in DTP.
148157|NCT01574326|O2|Outcome|FDP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP.
148158|NCT01574326|O1|Outcome|FDP-Placebo for Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP.
148159|NCT01574326|E3|Reported Event|DTP - Sevelamer Carbonate|Participants who received placebo and participants who received sevelamer carbonate in FDP received sevelamer carbonate for 26 weeks in DTP (median exposure of 183.5 days in participants who were on sevelamer carbonate in FDP and 183 days in participants who were on placebo in FDP).
148160|NCT01574326|E2|Reported Event|FDP - Sevelamer Carbonate|Participants exposed to sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for first 2 weeks in FDP (median exposure of 15 days).
148161|NCT01574326|E1|Reported Event|FDP - Placebo|Participants exposed to placebo (for sevelamer carbonate) for first 2 weeks in FDP (median exposure of 15 days).
148162|NCT01574248|B3|Baseline|Total|Total of all reporting groups
148163|NCT01574248|B2|Baseline|Placebo|"Subcutaneous at time 0 and 6 hours
Placebo: Subcutaneous at time 0 and 6 hours"
148164|NCT01574248|B1|Baseline|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
icatibant: Subcutaneous at time 0 and 6 hours"
148165|NCT01574248|P2|Participant Flow|Placebo|"Subcutaneous at time 0 and 6 hours
Placebo: Subcutaneous at time 0 and 6 hours"
148166|NCT01574248|P1|Participant Flow|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
icatibant: Subcutaneous at time 0 and 6 hours"
148167|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours
Placebo: Subcutaneous at time 0 and 6 hours"
148168|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
icatibant: Subcutaneous at time 0 and 6 hours"
148169|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours
Placebo: Subcutaneous at time 0 and 6 hours"
148170|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
icatibant: Subcutaneous at time 0 and 6 hours"
148171|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours
Placebo: Subcutaneous at time 0 and 6 hours"
148172|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
icatibant: Subcutaneous at time 0 and 6 hours"
148173|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours
Placebo: Subcutaneous at time 0 and 6 hours"
148174|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
icatibant: Subcutaneous at time 0 and 6 hours"
148175|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours
Placebo: Subcutaneous at time 0 and 6 hours"
148176|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
icatibant: Subcutaneous at time 0 and 6 hours"
148177|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours
Placebo: Subcutaneous at time 0 and 6 hours"
148178|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
icatibant: Subcutaneous at time 0 and 6 hours"
148179|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours
Placebo: Subcutaneous at time 0 and 6 hours"
148180|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
icatibant: Subcutaneous at time 0 and 6 hours"
168706|NCT01486446|B3|Baseline|Total|Total of all reporting groups
148197|NCT01574105|B2|Baseline|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
148198|NCT01574105|B1|Baseline|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
148199|NCT01574105|P2|Participant Flow|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
148200|NCT01574105|P1|Participant Flow|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
148201|NCT01574105|O2|Outcome|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
148202|NCT01574105|O1|Outcome|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
148203|NCT01574105|O2|Outcome|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
148204|NCT01574105|O1|Outcome|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
148205|NCT01574105|E2|Reported Event|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
148206|NCT01574105|E1|Reported Event|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
148207|NCT01574079|B3|Baseline|Total|Total of all reporting groups
148208|NCT01574079|B2|Baseline|Physical Therapy Plus Mirror Therapy|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
148209|NCT01574079|B1|Baseline|Traditional Physical Therapy|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
148210|NCT01574079|P2|Participant Flow|Physical Therapy Plus Mirror Therapy|The treatment group will receive traditional physical therapy with the addition of 15 minutes of mirror therapy consisting of lower extremity ankle dorsiflexion, knee flexion, and hip flexion. The participant will attempt to perform the exercises with both lower extremities. The patient will be blinded to the affected lower extremity with a mirror, and will be looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performs the activities.
148211|NCT01574079|P1|Participant Flow|Traditional Physical Therapy|The control group will receive traditional physical therapy which includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
148212|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
148213|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
148214|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
148215|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
148216|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
148217|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
148242|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
169017|NCT01484652|O2|Outcome|Placebo|2 tablets taken every 12 hours
148218|NCT01574079|E2|Reported Event|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
148219|NCT01574079|E1|Reported Event|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
148220|NCT01573767|B5|Baseline|Total|Total of all reporting groups
148325|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148221|NCT01573767|B4|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148222|NCT01573767|B3|Baseline|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148223|NCT01573767|B2|Baseline|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148224|NCT01573767|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148225|NCT01573767|P4|Participant Flow|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148226|NCT01573767|P3|Participant Flow|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148227|NCT01573767|P2|Participant Flow|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148228|NCT01573767|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148229|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148230|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148231|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148232|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148233|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148234|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148235|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148236|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148237|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148238|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148239|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148240|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148241|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148508|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
148243|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148244|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148245|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
154341|NCT01545700|O10|Outcome|Dexamethasone 4 mg 0-4 Hours-4 Hours|
148246|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148247|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148248|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148249|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148250|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148251|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148252|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148253|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148254|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148255|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148256|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148257|NCT01573767|E4|Reported Event|VI 25 OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148258|NCT01573767|E3|Reported Event|VI 12.5 OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148259|NCT01573767|E2|Reported Event|VI 6.25 OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148260|NCT01573767|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
148261|NCT01573624|B1|Baseline|All Treatments Combined|The participants received 3 of the 7 possible treatments during the 3 double blind treatment periods. Participants received study treatments in a crossover manner according to their randomization sequence. The 7 treatment regimens were, FF 100 mcg, FF 100 mcg + UMEC 15.6 mcg, FF 100 mcg + UMEC 31.25 mcg, FF 100 mcg + UMEC 62.5 mcg, FF 100 mcg + UMEC 125 mcg, FF 100 mcg + UMEC 250 mcg and FF 100 mcg + VI 25 mcg. The study treatments were administered via a DPI taken once daily in the morning for 14 days during each study period. The treatment periods were separated by 2 washout periods of 12-14 days each. During the two week run-in period and during the two washout period, participants were administered open-label FF 100 mcg once daily in the morning via a DPI. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148262|NCT01573624|P7|Participant Flow|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and vilanterol (VI) 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148263|NCT01573624|P6|Participant Flow|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148264|NCT01573624|P5|Participant Flow|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148326|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148265|NCT01573624|P4|Participant Flow|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148266|NCT01573624|P3|Participant Flow|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148267|NCT01573624|P2|Participant Flow|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and umeclidinium bromide (UMEC) 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148268|NCT01573624|P1|Participant Flow|FF 100 mcg|Participants received a dose of FF 100 mcg via a dry powder inhaler (DPI) once daily in the morning for 14 days in any one of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol metered-dose inhaler (MDI) was provided as the rescue medication.
148269|NCT01573624|O7|Outcome|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148270|NCT01573624|O6|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148271|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148272|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148273|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148274|NCT01573624|O2|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148275|NCT01573624|O1|Outcome|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148276|NCT01573624|O7|Outcome|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148509|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
148510|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
169018|NCT01484652|O1|Outcome|COV795|2 tablets taken every 12 hours
148277|NCT01573624|O6|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148278|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148279|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148280|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148281|NCT01573624|O2|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148282|NCT01573624|O1|Outcome|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148283|NCT01573624|O7|Outcome|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148284|NCT01573624|O6|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148285|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148286|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148287|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148288|NCT01573624|O2|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148289|NCT01573624|O1|Outcome|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148322|NCT01573260|P2|Participant Flow|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148290|NCT01573624|O7|Outcome|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148291|NCT01573624|O6|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148292|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148293|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148294|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148295|NCT01573624|O2|Outcome|FF 100mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148296|NCT01573624|O1|Outcome|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148297|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148298|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148299|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148300|NCT01573624|O2|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148301|NCT01573624|O1|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148302|NCT01573624|O5|Outcome|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148323|NCT01573260|P1|Participant Flow|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148511|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
148303|NCT01573624|O4|Outcome|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148304|NCT01573624|O3|Outcome|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148305|NCT01573624|O2|Outcome|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148306|NCT01573624|O1|Outcome|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148307|NCT01573624|E7|Reported Event|FF 100 mcg + VI 25 mcg|Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148308|NCT01573624|E6|Reported Event|FF 100 mcg + UMEC 250 mcg|Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148309|NCT01573624|E5|Reported Event|FF 100 mcg + UMEC 125 mcg|Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148310|NCT01573624|E4|Reported Event|FF 100 mcg + UMEC 62.5 mcg|Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148311|NCT01573624|E3|Reported Event|FF 100 mcg + UMEC 31.25 mcg|Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148312|NCT01573624|E2|Reported Event|FF 100 mcg + UMEC 15.6 mcg|Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148313|NCT01573624|E1|Reported Event|FF 100 mcg|Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
148314|NCT01573325|B1|Baseline|Study Popoulation|There was only one group as this was a descriptive prospective study
148315|NCT01573325|P1|Participant Flow|Study Popoulation|There was only one group as this was a descriptive prospective study. They all completed identical questionnaires including the Quality of Life Index, the Short-form Liver Disease Quality of Life tool, the Medical Outcomes Study Social Support Survey, the demographic tool and the Center for Epidemiological Studies Depression tool.
148316|NCT01573325|O1|Outcome|Population Predicted by Have Poor HRQOL by Depressive Symptoms|
148317|NCT01573325|O1|Outcome|Study Popoulation|There was only one group as this was a descriptive prospective study
148318|NCT01573325|E1|Reported Event|Study Popoulation|There was only one group as this was a descriptive prospective study
148319|NCT01573260|B3|Baseline|Total|Total of all reporting groups
148320|NCT01573260|B2|Baseline|Tango|
148321|NCT01573260|B1|Baseline|Control|
148512|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
148513|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
148324|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
149105|NCT01569763|B1|Baseline|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Minerva Endometrial Ablation system
148327|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148328|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148329|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148330|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148331|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148332|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148333|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148334|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148335|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148336|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148337|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148338|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148339|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148340|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148341|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148342|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148343|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148344|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148345|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148346|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Intervention: Patient will receive information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148347|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly class of argentinean tango for a period of 3-months the intervention for this arm
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148465|NCT01572948|O1|Outcome|Placebo|"The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient.
placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient"
148348|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148349|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148350|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148351|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148352|NCT01573260|E2|Reported Event|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.
Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
148353|NCT01573260|E1|Reported Event|Argentinean Tango|"A biweekly 3-month tango program
Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
148354|NCT01573000|B3|Baseline|Total|Total of all reporting groups
148355|NCT01573000|B2|Baseline|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148356|NCT01573000|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148357|NCT01573000|P2|Participant Flow|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148358|NCT01573000|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148359|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148360|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148514|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
148515|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
173823|NCT01467960|B2|Baseline|Group II|Healthy Subjects aged 40-65
148361|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148362|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148363|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148364|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148365|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148366|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148367|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148368|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148369|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148370|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148371|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148516|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
148517|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
148518|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
148372|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148564|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
148373|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148374|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148375|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148376|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148377|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148378|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148379|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148380|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148381|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148382|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148383|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148522|NCT01572792|E4|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
148395|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148384|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148385|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148386|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148387|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148388|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148389|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148390|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148391|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148392|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148393|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148394|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148519|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
148520|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
148521|NCT01572792|E5|Reported Event|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
148396|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148397|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148398|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148399|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148400|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148401|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148402|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148403|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148404|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148405|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148418|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148464|NCT01572948|O2|Outcome|Daliresp|"The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models"
148406|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148407|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148408|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148409|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148410|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148411|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148412|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148413|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148414|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148415|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148416|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148417|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148419|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148420|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148421|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148422|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148423|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148424|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148425|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148426|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148427|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148428|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148429|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148442|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148430|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148431|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148432|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148433|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148434|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148435|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148436|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148437|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148438|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148439|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148440|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148441|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148462|NCT01572948|O2|Outcome|Placebo|500microgram white tablet
148463|NCT01572948|O1|Outcome|Roflumilast|group randomized to 30 day supply of white tablet 500microgram
173824|NCT01467960|B1|Baseline|Group I|Healthy Subjects aged 20-40
148443|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148444|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148445|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148446|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148447|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148448|NCT01573000|E3|Reported Event|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148449|NCT01573000|E2|Reported Event|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148450|NCT01573000|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
148451|NCT01572948|B3|Baseline|Total|Total of all reporting groups
148452|NCT01572948|B2|Baseline|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
148453|NCT01572948|B1|Baseline|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
148454|NCT01572948|P2|Participant Flow|Placebo|500microgram white tablet
148455|NCT01572948|P1|Participant Flow|Roflumilast|group randomized to 30 day supply of white tablet 500microgram
148456|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
148457|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
148458|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
148459|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
148460|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
148461|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
148466|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
148467|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
148468|NCT01572948|E2|Reported Event|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
148469|NCT01572948|E1|Reported Event|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
148470|NCT01572792|B6|Baseline|Total|Total of all reporting groups
148471|NCT01572792|B5|Baseline|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
148472|NCT01572792|B4|Baseline|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
148473|NCT01572792|B3|Baseline|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
148474|NCT01572792|B2|Baseline|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
148475|NCT01572792|B1|Baseline|Placebo|Placebo administered BID by inhalation
148476|NCT01572792|P5|Participant Flow|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
148477|NCT01572792|P4|Participant Flow|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
148478|NCT01572792|P3|Participant Flow|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
148479|NCT01572792|P2|Participant Flow|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
148480|NCT01572792|P1|Participant Flow|Placebo|Placebo administered BID by inhalation
148481|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
148482|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
148483|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
148484|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
148485|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
148486|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
148487|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
148488|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
148489|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
148490|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
148491|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
148492|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
148493|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
148494|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
148495|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
148496|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
148497|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
148498|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
148499|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
148500|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
148501|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
148502|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
148503|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
148504|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
148505|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
148506|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
148507|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
174863|NCT01465048|E1|Reported Event|PfSPZ Challenge 2,500 ID|
148523|NCT01572792|E3|Reported Event|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
148524|NCT01572792|E2|Reported Event|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
148525|NCT01572792|E1|Reported Event|Placebo|Placebo administered BID by inhalation
148526|NCT01572740|B3|Baseline|Total|Total of all reporting groups
148565|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
151821|NCT01559311|E3|Reported Event|DDDR|Control Group – DDDR Standard Therapy
148527|NCT01572740|B2|Baseline|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148528|NCT01572740|B1|Baseline|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148529|NCT01572740|P2|Participant Flow|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148530|NCT01572740|P1|Participant Flow|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148531|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148532|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148533|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148534|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148535|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148536|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
174864|NCT01465022|B4|Baseline|Total|Total of all reporting groups
148566|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
148567|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
148568|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
148537|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148538|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148539|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148540|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148541|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148542|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148543|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148544|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148545|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148546|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148547|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148548|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148549|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148550|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148551|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148552|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148553|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148554|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148555|NCT01572740|E2|Reported Event|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148556|NCT01572740|E1|Reported Event|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.
All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
148557|NCT01572727|B3|Baseline|Total|Total of all reporting groups
148558|NCT01572727|B2|Baseline|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
148559|NCT01572727|B1|Baseline|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
148560|NCT01572727|P2|Participant Flow|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
148561|NCT01572727|P1|Participant Flow|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
148562|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
148563|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
148569|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
148570|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
148571|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
148572|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
148573|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
148574|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
148575|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
148576|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
148577|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
148578|NCT01572727|E2|Reported Event|Placebo 100 mg Plus Paclitaxel 80 mg Per m2|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
148579|NCT01572727|E1|Reported Event|Buparlisib (BKM120) 100 mg Plus Paclitaxel 80 mg Per m2|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
148580|NCT01572675|B3|Baseline|Total|Total of all reporting groups
148581|NCT01572675|B2|Baseline|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148582|NCT01572675|B1|Baseline|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148583|NCT01572675|P2|Participant Flow|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148584|NCT01572675|P1|Participant Flow|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148585|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148586|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148587|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148588|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148589|NCT01572675|O3|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148590|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148591|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148592|NCT01572675|O2|Outcome|Group Celebrex®|Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148593|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148721|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
148722|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
148594|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148595|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148596|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
149106|NCT01569763|P2|Participant Flow|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
148597|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148598|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148599|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148600|NCT01572675|O2|Outcome|Group Celebrex®|Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148601|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148602|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148603|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148604|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148605|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148606|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148607|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148608|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148609|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148610|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148611|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148612|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148613|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148614|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148615|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148616|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148617|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148618|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148619|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148620|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
149107|NCT01569763|P1|Participant Flow|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
154342|NCT01545700|O9|Outcome|Dexamethasone 4 mg 0-4 Hours-3 Hours|
148621|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148622|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148623|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148624|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148625|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148626|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148627|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148628|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148629|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148630|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148631|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148632|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148633|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148634|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148635|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148636|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148637|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148638|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148639|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148640|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148641|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148642|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148723|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
148724|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
148643|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148644|NCT01572675|O4|Outcome|More Than One Year|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for more than one year
151822|NCT01559311|E2|Reported Event|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
148645|NCT01572675|O3|Outcome|From Three Months to One Year|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from three months to one year
148646|NCT01572675|O2|Outcome|From One to Three Months|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from one to three months total
148647|NCT01572675|O1|Outcome|Up to Thirty Days|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for ≤ 30 days
148648|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148649|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148650|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148651|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148652|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148653|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148654|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148655|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148656|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148657|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148658|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148659|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148660|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148661|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148662|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148663|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148664|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148665|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148666|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148667|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148725|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
174865|NCT01465022|B3|Baseline|Not Randomized|70 women who were enrolled.
148668|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
149108|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
154343|NCT01545700|O8|Outcome|Dexamethasone 4 mg 0-4 Hours-2 Hours|
148669|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148670|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148671|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148672|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148673|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148674|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148675|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148676|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148677|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148678|NCT01572675|E2|Reported Event|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148679|NCT01572675|E1|Reported Event|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
148680|NCT01572298|B3|Baseline|Total|Total of all reporting groups
148681|NCT01572298|B2|Baseline|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)
allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
148682|NCT01572298|B1|Baseline|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)
allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
148683|NCT01572298|P2|Participant Flow|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)
allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
148684|NCT01572298|P1|Participant Flow|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)
allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
148685|NCT01572298|O2|Outcome|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)
allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
148686|NCT01572298|O1|Outcome|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)
allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
148687|NCT01572298|E2|Reported Event|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)
allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
148688|NCT01572298|E1|Reported Event|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)
allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
148689|NCT01572207|B3|Baseline|Total|Total of all reporting groups
148690|NCT01572207|B2|Baseline|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
148726|NCT01571453|E2|Reported Event|Venlafaxine|Venlafaxine extended release: 150 mg/day
148727|NCT01571453|E1|Reported Event|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
148728|NCT01571362|B1|Baseline|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148770|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148691|NCT01572207|B1|Baseline|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
148692|NCT01572207|P2|Participant Flow|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
148693|NCT01572207|P1|Participant Flow|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
148694|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
148695|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
148696|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
148697|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
148698|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
148699|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
148700|NCT01572207|E2|Reported Event|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
148701|NCT01572207|E1|Reported Event|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
148702|NCT01571557|B1|Baseline|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
148703|NCT01571557|P1|Participant Flow|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
148704|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
148705|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
148706|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
148707|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
148708|NCT01571557|E1|Reported Event|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
148709|NCT01571453|B3|Baseline|Total|Total of all reporting groups
148710|NCT01571453|B2|Baseline|Venlafaxine|Venlafaxine extended release: 150 mg/day
148711|NCT01571453|B1|Baseline|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
148712|NCT01571453|P2|Participant Flow|Venlafaxine|Venlafaxine extended release 150 mg/day
148713|NCT01571453|P1|Participant Flow|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
148714|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
148715|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
148716|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
148717|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
148718|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
148719|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
148720|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
148729|NCT01571362|P3|Participant Flow|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148730|NCT01571362|P2|Participant Flow|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148731|NCT01571362|P1|Participant Flow|Open ALO-02|Participants received AL0-02 extended-release capsules, orally (PO), twice daily (BID), at total daily doses of oxycodone from 20 to 160 milligrams (mg) in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148732|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148733|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148734|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148735|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148736|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148737|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148738|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148739|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148740|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148741|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148983|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
148984|NCT01570309|E2|Reported Event|Sugar Pill|Matching placebo
148742|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148743|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148744|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148745|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148746|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148747|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148748|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148749|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148750|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148751|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148752|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148753|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148754|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148755|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148756|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148757|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148758|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148759|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148760|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148761|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148762|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148763|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148764|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148765|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148766|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148767|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148768|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148769|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148771|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148772|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148773|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148774|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148775|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148776|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148777|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148778|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148779|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148780|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148781|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148782|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148783|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
149104|NCT01569763|B2|Baseline|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
151823|NCT01559311|E1|Reported Event|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
148784|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148785|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148786|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148787|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148788|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148789|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148790|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148791|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148792|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148793|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148794|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148795|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148852|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148985|NCT01570309|E1|Reported Event|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
149098|NCT01569815|E5|Reported Event|LCZ696 400 mg - All Healthy Subjects|LCZ696 400 mg - All healthy subjects
148796|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148797|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148798|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148799|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148800|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148801|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148802|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148803|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148804|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148805|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148806|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148807|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148808|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148809|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148810|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148811|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148812|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148813|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148814|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148815|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148816|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148817|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148818|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148819|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148820|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148821|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148822|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148823|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148824|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148825|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
175161|NCT01464229|B3|Baseline|Total|Total of all reporting groups
148826|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148827|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148828|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148829|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148830|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148831|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148832|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148833|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148834|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148835|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148836|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148837|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148921|NCT01570751|O1|Outcome|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
148838|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148839|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148840|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148841|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148842|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148843|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148844|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148845|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148846|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148847|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148848|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148849|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148850|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148851|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148853|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148854|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148855|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148856|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148857|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148858|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148859|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148860|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148861|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148862|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148863|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148922|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
149099|NCT01569815|E4|Reported Event|LCZ696 400 mg - Moderate - Matched Healthy Subjects|LCZ696 400 mg - Moderate - Matched healthy subjects
148864|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148865|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148866|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148867|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148868|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148869|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148870|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148871|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148872|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148873|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148874|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148923|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
149100|NCT01569815|E3|Reported Event|LCZ696 400 mg - Moderate - Renal Impaired Patients|LCZ696 400 mg - Moderate - Renal impaired patients
184335|NCT01436006|B1|Baseline|CT Scan|patient with cancer
148875|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148876|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148877|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148878|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148879|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148880|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148881|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148882|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148883|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148884|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148885|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148886|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148924|NCT01570751|O2|Outcome|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
148887|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148888|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148889|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148890|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148891|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148892|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148893|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148894|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148895|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148896|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148897|NCT01571362|E3|Reported Event|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
148973|NCT01570309|P1|Participant Flow|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
148974|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
148975|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
148976|NCT01570309|O2|Outcome|Placebo|Sugar Pill
148977|NCT01570309|O1|Outcome|Active Therapy|Ergocalciferol 50,000 U q weekly x 12 weeks
148898|NCT01571362|E2|Reported Event|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
148899|NCT01571362|E1|Reported Event|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
148900|NCT01571232|B3|Baseline|Total|Total of all reporting groups
148901|NCT01571232|B2|Baseline|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.
intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
148902|NCT01571232|B1|Baseline|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4
dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
148903|NCT01571232|P2|Participant Flow|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.
intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
148904|NCT01571232|P1|Participant Flow|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4
dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
148905|NCT01571232|O2|Outcome|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.
intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
148906|NCT01571232|O1|Outcome|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4
dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
148907|NCT01571232|O2|Outcome|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.
intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
148908|NCT01571232|O1|Outcome|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4
dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
148909|NCT01571232|O2|Outcome|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.
intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
148910|NCT01571232|O1|Outcome|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4
dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
148911|NCT01571232|E2|Reported Event|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.
intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
148912|NCT01571232|E1|Reported Event|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4
dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
148913|NCT01570751|B3|Baseline|Total|Total of all reporting groups
148914|NCT01570751|B2|Baseline|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
148915|NCT01570751|B1|Baseline|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
148916|NCT01570751|P2|Participant Flow|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
148917|NCT01570751|P1|Participant Flow|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
148918|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
148919|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
148920|NCT01570751|O2|Outcome|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
148978|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
148925|NCT01570751|O1|Outcome|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
148926|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
148927|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
148928|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
148929|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
148930|NCT01570751|E2|Reported Event|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
148931|NCT01570751|E1|Reported Event|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
148932|NCT01570686|B3|Baseline|Total|Total of all reporting groups
148933|NCT01570686|B2|Baseline|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148934|NCT01570686|B1|Baseline|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148935|NCT01570686|P2|Participant Flow|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148936|NCT01570686|P1|Participant Flow|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148937|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148938|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148939|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148940|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148941|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148942|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148943|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148944|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148945|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148946|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148947|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148948|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148949|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148950|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148951|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148952|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148953|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148954|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148955|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148956|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148957|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
148958|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148959|NCT01570686|E2|Reported Event|Aliskiren 300 mg (Fasted)|Aliskiren 300 mg once daily taken after after an overnight fast
148960|NCT01570686|E1|Reported Event|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
148961|NCT01570634|B1|Baseline|Open Label CASAD|Treatment with CASAD for 14 days
148962|NCT01570634|P1|Participant Flow|Open Label CASAD|Treatment with Calcium Aluminosilicate Anti-Diarrheal (CASAD) for 14 days
148963|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
148964|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
148965|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
148966|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
148967|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
148968|NCT01570634|E1|Reported Event|Open Label CASAD|Treatment with CASAD for 14 days
148969|NCT01570309|B3|Baseline|Total|Total of all reporting groups
148970|NCT01570309|B2|Baseline|Sugar Pill|Matching placebo
148971|NCT01570309|B1|Baseline|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
148972|NCT01570309|P2|Participant Flow|Sugar Pill|Matching placebo
148986|NCT01570244|B1|Baseline|All Subjects|The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.
148987|NCT01570244|P1|Participant Flow|All Subjects|"The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.
Period 1: Microgynon (150 μg Ethinylestradiol+30 μg Levonorgestrel) tablets.
Period 2: Microgynon tablets and Faldaprevir."
148988|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
148989|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
148990|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
148991|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
148992|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
148993|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
148994|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
148995|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
148996|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
148997|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
148998|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
148999|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
149000|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
149001|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
149002|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
149003|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
149004|NCT01570244|E2|Reported Event|Microgynon + BI 201335|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
149005|NCT01570244|E1|Reported Event|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
149006|NCT01570192|B3|Baseline|Total|Total of all reporting groups
149007|NCT01570192|B2|Baseline|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.
**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.
I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage
Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
149008|NCT01570192|B1|Baseline|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:
IV meropenem (2 g infused over 3 hrs q 8 hr);
a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)
tobramycin nebulization
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.
IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)
Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.
tobramycin nebulization: tobramycin nebulization 600mg/day"
149101|NCT01569815|E2|Reported Event|LCZ696 400 mg - Mild - Matched Healthy Subjects|LCZ696 400 mg - Mild - Matched healthy subjects
149102|NCT01569815|E1|Reported Event|LCZ696 400 mg - Mild - Renal Impaired Patients|LCZ696 400 mg - Mild - Renal impaired patients
149009|NCT01570192|P2|Participant Flow|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.
**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.
I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage
Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
149010|NCT01570192|P1|Participant Flow|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:
IV meropenem (2 g infused over 3 hrs q 8 hr);
a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)
tobramycin nebulization
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.
IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)
Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.
tobramycin nebulization: tobramycin nebulization 600mg/day"
149011|NCT01570192|O2|Outcome|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.
**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.
I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage
Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
149012|NCT01570192|O1|Outcome|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:
IV meropenem (2 g infused over 3 hrs q 8 hr);
a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)
tobramycin nebulization
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.
IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)
Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.
tobramycin nebulization: tobramycin nebulization 600mg/day"
149013|NCT01570192|E2|Reported Event|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.
**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.
I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage
Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
149014|NCT01570192|E1|Reported Event|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:
IV meropenem (2 g infused over 3 hrs q 8 hr);
a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)
tobramycin nebulization
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.
IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)
Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.
tobramycin nebulization: tobramycin nebulization 600mg/day"
149015|NCT01569841|B1|Baseline|Full Analysis Set|The full analysis set (FAS) included all randomised subjects.
149016|NCT01569841|P2|Participant Flow|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.
Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
149035|NCT01569828|P2|Participant Flow|Matched Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min.Once daily administration of 400 mg LCZ696 p.o. for 5 days
149103|NCT01569763|B3|Baseline|Total|Total of all reporting groups
149017|NCT01569841|P1|Participant Flow|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.
Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
149018|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.
Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
149019|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.
Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
149020|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.
Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
149021|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.
Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
149022|NCT01569841|O2|Outcome|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.
Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
149023|NCT01569841|O1|Outcome|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.
Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
149024|NCT01569841|O2|Outcome|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.
Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
149085|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149086|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149087|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149088|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149025|NCT01569841|O1|Outcome|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.
Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
149026|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.
Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
149027|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.
Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
149028|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.
Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
149029|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.
Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
149030|NCT01569841|E2|Reported Event|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.
Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
149031|NCT01569841|E1|Reported Event|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.
Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.
Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
149032|NCT01569828|B3|Baseline|Total|Total of all reporting groups
149033|NCT01569828|B2|Baseline|Matched Healthy Volunteers|"All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min.
Once daily administration of 400 mg LCZ696 p.o. for 5 days"
149034|NCT01569828|B1|Baseline|Severe Renal Impaired Subjects|"Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.
Once daily administration of 400 mg LCZ696 p.o. for 5 days"
149089|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149090|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149091|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149092|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149036|NCT01569828|P1|Participant Flow|Severe Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149037|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149038|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.Once daily administration of 400 mg LCZ696 p.o. for 5 days
149039|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149040|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149041|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149042|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149043|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149044|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149045|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149093|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149094|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149095|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149096|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149097|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149194|NCT01569152|B3|Baseline|Total|Total of all reporting groups
149046|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149047|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149048|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149049|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149050|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
149051|NCT01569828|E2|Reported Event|Matched Healthy Volunteers|
149052|NCT01569828|E1|Reported Event|Severe Renal Impaired Patients|
149053|NCT01569815|B5|Baseline|Total|Total of all reporting groups
149054|NCT01569815|B4|Baseline|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149055|NCT01569815|B3|Baseline|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149056|NCT01569815|B2|Baseline|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149057|NCT01569815|B1|Baseline|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149058|NCT01569815|P4|Participant Flow|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149059|NCT01569815|P3|Participant Flow|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149060|NCT01569815|P2|Participant Flow|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149061|NCT01569815|P1|Participant Flow|Mild Renal Impaired|LCZ696 400 mg once daily for 5 days
149062|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149063|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149064|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149065|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149066|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149067|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149068|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149069|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149070|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149071|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149072|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149073|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149074|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149075|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149076|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149077|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149078|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149079|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149080|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149081|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149082|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149083|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
149084|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
149109|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
149110|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
149111|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
149112|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
149113|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
149114|NCT01569763|E2|Reported Event|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
149115|NCT01569763|E1|Reported Event|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
149116|NCT01569568|B3|Baseline|Total|Total of all reporting groups
149117|NCT01569568|B2|Baseline|Healthy Controls|"males and females ages 7-60 years who are healthy controls
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149118|NCT01569568|B1|Baseline|Subjects With OTCD|"males and females ages 7-60 years with OTCD
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149119|NCT01569568|P2|Participant Flow|Healthy Controls|"males and females ages 7-60 years who are healthy controls
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149120|NCT01569568|P1|Participant Flow|Subjects With OTCD|"males and females ages 7-60 years with OTCD
MRI scanning: 1H Magnetic Resonance Spectroscopy (MRS), Diffusion Tensor Imaging (DTI), functional magnetic resonance imaging (fMRI)
Cognitive testing: Neuropsychological testing"
149121|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149122|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149123|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149124|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149125|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149126|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149127|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149128|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149129|NCT01569568|E2|Reported Event|Healthy Controls|"males and females ages 7-60 years who are healthy controls
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149130|NCT01569568|E1|Reported Event|Subjects With OTCD|"males and females ages 7-60 years with OTCD
MRI scanning: 1H MRS, DTI, FMRI
Cognitive testing: Neuropsychological testing"
149131|NCT01569529|B3|Baseline|Total|Total of all reporting groups
149132|NCT01569529|B2|Baseline|No ad Exposure|Young adults, who registered for the cessation program, one month prior to presenting the online advertisements (intervention).
149133|NCT01569529|B1|Baseline|Ad Exposure|"Young Adults, who register for the cessation program, by clicking through the online advertisements (intervention).
Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
149134|NCT01569529|P2|Participant Flow|No Ad Exposure|Young adults, who registered for the cessation program, after arriving at the program site though established means (e.g., search engine results), one month prior to presenting the tailored online advertisements (intervention).
149135|NCT01569529|P1|Participant Flow|Ad Exposure|"Young Adults, who register for the cessation program, by clicking through the online advertisements (intervention).
Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
149136|NCT01569529|O2|Outcome|No ad Exposure|Young adults, who enrolled for the cessation program, one month prior to presenting the online advertisements (intervention).
149137|NCT01569529|O1|Outcome|Ad Exposure|"Young Adults, who enrolled for the cessation program, by clicking through the online advertisements (intervention).
Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
149138|NCT01569529|E2|Reported Event|No ad Exposure|Young adults, who enrolled for the cessation program, one month prior to presenting the online advertisements (intervention).
149139|NCT01569529|E1|Reported Event|Ad Exposure|"Young Adults, who enrolled for the cessation program, by clicking through the online advertisements (intervention).
Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
149140|NCT01569464|B3|Baseline|Total|Total of all reporting groups
149141|NCT01569464|B2|Baseline|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149195|NCT01569152|B2|Baseline|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
186719|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
149142|NCT01569464|B1|Baseline|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149143|NCT01569464|P2|Participant Flow|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
154142|NCT01546636|B2|Baseline|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
149144|NCT01569464|P1|Participant Flow|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg / 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149145|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149146|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149147|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149148|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149149|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149150|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149151|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149152|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149153|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/r24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149154|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149155|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149156|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149157|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149158|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149159|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149160|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149161|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149196|NCT01569152|B1|Baseline|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149249|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149162|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149163|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149164|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149165|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149166|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149167|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149168|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149169|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149170|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149171|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149172|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149173|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/r24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149174|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149175|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149176|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149177|NCT01569464|E2|Reported Event|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours
7 weeks"
149178|NCT01569464|E1|Reported Event|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
7 weeks (titration plus maintenance)"
149179|NCT01569438|B3|Baseline|Total|Total of all reporting groups
149180|NCT01569438|B2|Baseline|Sugar Pill|Sugar Pill: Placebo
149181|NCT01569438|B1|Baseline|Gefapixant|Gefapixant: BID
149182|NCT01569438|P2|Participant Flow|Gefapixant|Gefapixant: BID
149183|NCT01569438|P1|Participant Flow|Sugar Pill|Sugar Pill: Placebo
149184|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
149185|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
149186|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
149187|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
149188|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
149189|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
149190|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
149191|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
149192|NCT01569438|E2|Reported Event|Gefapixant|Gefapixant: BID
149193|NCT01569438|E1|Reported Event|Sugar Pill|Sugar Pill: Placebo
149197|NCT01569152|P3|Participant Flow|Safety Extension Period 3: MK-8457|MK-8457 100 mg BID + MTX for up to approximately 52 weeks in Safety Extension Period 3. Participants who completed or had early escape from Base Study Phase IIa were eligible to enroll in Safety Extension Period 3.
149198|NCT01569152|P2|Participant Flow|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149199|NCT01569152|P1|Participant Flow|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149200|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149201|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149202|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149203|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149204|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149205|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149206|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149207|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149208|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149209|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149210|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149211|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149212|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149213|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149214|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149215|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149216|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149217|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149218|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149219|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149220|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149221|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149222|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149223|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149224|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149225|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149226|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149227|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149228|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149229|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149230|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149231|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149232|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149233|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149234|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149235|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149236|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149237|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149238|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149239|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149240|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149241|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149242|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149243|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149244|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149245|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149246|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149247|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149248|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149250|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149251|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149252|NCT01569152|E3|Reported Event|Safety Extension Period 3: MK-8457|MK-8457 100 mg BID + MTX for up to approximately 52 weeks in Safety Extension Period 3. Participants who completed or had early escape from Base Study Phase IIa were eligible to enroll in Safety Extension Period 3.
149253|NCT01569152|E2|Reported Event|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
149254|NCT01569152|E1|Reported Event|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
149255|NCT01569126|B7|Baseline|Total|Total of all reporting groups
149256|NCT01569126|B6|Baseline|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149257|NCT01569126|B5|Baseline|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149258|NCT01569126|B4|Baseline|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149259|NCT01569126|B3|Baseline|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
149260|NCT01569126|B2|Baseline|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149261|NCT01569126|B1|Baseline|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149262|NCT01569126|P6|Participant Flow|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149263|NCT01569126|P5|Participant Flow|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149264|NCT01569126|P4|Participant Flow|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149265|NCT01569126|P3|Participant Flow|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
149266|NCT01569126|P2|Participant Flow|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149267|NCT01569126|P1|Participant Flow|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149268|NCT01569126|O6|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149269|NCT01569126|O5|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149270|NCT01569126|O4|Outcome|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149271|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
149272|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149273|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149274|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149275|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149276|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149277|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149278|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149397|NCT01568905|B1|Baseline|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette (0.400 mg/g; menthol 0.405 mg/g): smoke the study cigarette exclusively for one week
149279|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149280|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
149281|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149282|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149283|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
149284|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149285|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149286|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
149287|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149288|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149289|NCT01569126|O3|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149290|NCT01569126|O2|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149291|NCT01569126|O1|Outcome|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149292|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
149293|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149294|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149295|NCT01569126|E6|Reported Event|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149296|NCT01569126|E5|Reported Event|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149297|NCT01569126|E4|Reported Event|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
149298|NCT01569126|E3|Reported Event|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
149299|NCT01569126|E2|Reported Event|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149300|NCT01569126|E1|Reported Event|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
149301|NCT01569087|B4|Baseline|Total|Total of all reporting groups
149302|NCT01569087|B3|Baseline|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
149303|NCT01569087|B2|Baseline|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149304|NCT01569087|B1|Baseline|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149305|NCT01569087|P3|Participant Flow|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
149306|NCT01569087|P2|Participant Flow|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
150180|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
149307|NCT01569087|P1|Participant Flow|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149398|NCT01568905|P3|Participant Flow|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
149399|NCT01568905|P2|Participant Flow|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
149308|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
149309|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149310|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149311|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
149312|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149313|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149314|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
149315|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149316|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149317|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
149318|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149319|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149320|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
149321|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149322|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149323|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
149324|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149325|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
150181|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
149400|NCT01568905|P1|Participant Flow|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
149401|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
149326|NCT01569087|E3|Reported Event|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
149327|NCT01569087|E2|Reported Event|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149328|NCT01569087|E1|Reported Event|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
149329|NCT01569074|B6|Baseline|Total|Total of all reporting groups
149330|NCT01569074|B5|Baseline|PLACEBO PO|Dosing Group E
149331|NCT01569074|B4|Baseline|FOSTA 50 MG BID PO|Dosing Group D
149332|NCT01569074|B3|Baseline|FOSTA 75 MG BID PO|Dosing Group C
149333|NCT01569074|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149334|NCT01569074|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
149335|NCT01569074|P5|Participant Flow|PLACEBO PO|Dosing Group E
149336|NCT01569074|P4|Participant Flow|FOSTA 50 MG BID PO|Dosing Group D
149337|NCT01569074|P3|Participant Flow|FOSTA 75 MG BID PO|Dosing Group C
149338|NCT01569074|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149339|NCT01569074|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
149340|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
149341|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
149342|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
149343|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149344|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
149345|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
149346|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
149347|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
149348|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149349|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
149350|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
149351|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
149352|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
149353|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149354|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
149355|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
149356|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
149357|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
149358|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149359|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
149360|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
149361|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
149362|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
149363|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149364|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
149365|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
149366|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
149367|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
149368|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149369|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
149370|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
149371|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
149372|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
149373|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149374|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
149375|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
149376|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
149377|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
149378|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149379|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
149380|NCT01569074|O4|Outcome|FOSTA 100 MG BID PO|Dosing Group A
149381|NCT01569074|O3|Outcome|PLACEBO PO|Dosing Group E
149382|NCT01569074|O2|Outcome|FOSTA 50 MG BID PO|Dosing Group D
149383|NCT01569074|O1|Outcome|FOSTA 75 MG BID PO|Dosing Group C
149384|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
149385|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
149386|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
149387|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149388|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
149389|NCT01569074|E5|Reported Event|PLACEBO PO|Dosing Group E
149390|NCT01569074|E4|Reported Event|FOSTA 75 MG BID PO|Dosing Group C
149391|NCT01569074|E3|Reported Event|FOSTA 50 MG BID PO|Dosing Group D
149392|NCT01569074|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
149393|NCT01569074|E1|Reported Event|FOSTA 100 MG BID PO|Dosing Group A
149394|NCT01568905|B4|Baseline|Total|Total of all reporting groups
149395|NCT01568905|B3|Baseline|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette (10.4 mg/g; menthol: 12.3): smoke the study cigarette exclusively for one week
149396|NCT01568905|B2|Baseline|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette (5.86 mg/g menthol 5.87 mg/g): smoke the study cigarette exclusively for one week
186720|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
149402|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
149403|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
149404|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
149405|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
149406|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
149407|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
149408|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
149409|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
149410|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
149411|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
149412|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
149413|NCT01568905|E3|Reported Event|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
149414|NCT01568905|E2|Reported Event|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
149415|NCT01568905|E1|Reported Event|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
149416|NCT01568892|B3|Baseline|Total|Total of all reporting groups
149417|NCT01568892|B2|Baseline|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149418|NCT01568892|B1|Baseline|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149419|NCT01568892|P2|Participant Flow|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149420|NCT01568892|P1|Participant Flow|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149421|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149422|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149423|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149424|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149425|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149426|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149466|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
149427|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149469|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
149428|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149429|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149430|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149431|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149432|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149433|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149434|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149435|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149436|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149437|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149438|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149439|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149440|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149441|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149442|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149443|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149444|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149467|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
149445|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149446|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149447|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149448|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149449|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149450|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149451|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149452|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149453|NCT01568892|E2|Reported Event|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149454|NCT01568892|E1|Reported Event|DTG 50mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
149455|NCT01568866|B3|Baseline|Total|Total of all reporting groups
149456|NCT01568866|B2|Baseline|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
149457|NCT01568866|B1|Baseline|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
149458|NCT01568866|P2|Participant Flow|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
149459|NCT01568866|P1|Participant Flow|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
149460|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
149461|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
149462|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
149463|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
149464|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
149465|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
151169|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
149468|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
149470|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
149471|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
149472|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
149473|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
149474|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
149475|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
149476|NCT01568866|E2|Reported Event|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
149477|NCT01568866|E1|Reported Event|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
149478|NCT01568827|B3|Baseline|Total|Total of all reporting groups
149479|NCT01568827|B2|Baseline|No Intervention|Water without lypholized black raspberry powder
149480|NCT01568827|B1|Baseline|Black-raspberry Powder|Black-raspberry powder: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries
149481|NCT01568827|P2|Participant Flow|Blackraspberry Slurry First, Then Washout, Then Water|Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
149482|NCT01568827|P1|Participant Flow|Water First, Then Washout, Then Blackraspberry Slurry|8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days
149483|NCT01568827|O2|Outcome|Blackraspberry Slurry|Blackraspberry slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries mixed with 8 oz water
149484|NCT01568827|O1|Outcome|Water|Water without lypholized black raspberry powder
149485|NCT01568827|E2|Reported Event|Water, Washout, Black-raspberry Slurry|Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.
149486|NCT01568827|E1|Reported Event|Black-raspberry Slurry, Washout, Water|Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.
149487|NCT01568593|B3|Baseline|Total|Total of all reporting groups
149488|NCT01568593|B2|Baseline|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
149489|NCT01568593|B1|Baseline|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
149490|NCT01568593|P2|Participant Flow|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
149491|NCT01568593|P1|Participant Flow|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
149492|NCT01568593|O2|Outcome|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
149493|NCT01568593|O1|Outcome|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
149494|NCT01568593|E2|Reported Event|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
149495|NCT01568593|E1|Reported Event|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
149496|NCT01568424|B1|Baseline|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
149497|NCT01568424|P1|Participant Flow|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
149498|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
149499|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
149500|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
149501|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
149502|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
149503|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
149504|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
150106|NCT01566149|B2|Baseline|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
149505|NCT01568424|E1|Reported Event|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
149506|NCT01568112|B5|Baseline|Total|Total of all reporting groups
149507|NCT01568112|B4|Baseline|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149508|NCT01568112|B3|Baseline|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149509|NCT01568112|B2|Baseline|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149510|NCT01568112|B1|Baseline|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149511|NCT01568112|P4|Participant Flow|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149512|NCT01568112|P3|Participant Flow|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149513|NCT01568112|P2|Participant Flow|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149514|NCT01568112|P1|Participant Flow|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149515|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149516|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149517|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149518|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149519|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149520|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149521|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149522|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149523|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149524|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149525|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149526|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149527|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149528|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149529|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149530|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149531|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149532|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149533|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149534|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149535|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149907|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
149536|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149537|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149538|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149539|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149540|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149541|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149542|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149543|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149544|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149545|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149546|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149547|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149548|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149549|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149550|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149551|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149552|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149553|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149554|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149555|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149556|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149557|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149558|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149559|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149560|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149561|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149562|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149563|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149564|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149565|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
151810|NCT01559311|B2|Baseline|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
149566|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
150103|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
149567|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149568|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149569|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149570|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149571|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149572|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149573|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149574|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149575|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149576|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149577|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149578|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149579|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149580|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149581|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149582|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149583|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149584|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149585|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149586|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149587|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149588|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149589|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149590|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149591|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149592|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149593|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149594|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149595|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149596|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149902|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
150104|NCT01566162|E1|Reported Event|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
149597|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149598|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149599|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149600|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149601|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149602|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149603|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149604|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149605|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149606|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149607|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149608|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149609|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149610|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149611|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149612|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149613|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149614|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149615|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149616|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149617|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149618|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149619|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149620|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149621|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149622|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149623|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
149624|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149625|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149626|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149627|NCT01568112|E4|Reported Event|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
150182|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
149628|NCT01568112|E3|Reported Event|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
149629|NCT01568112|E2|Reported Event|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
149630|NCT01568112|E1|Reported Event|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
149631|NCT01568073|B6|Baseline|Total|Total of all reporting groups
149632|NCT01568073|B5|Baseline|OPC 50mg|OPC, Opicapone 50mg
149633|NCT01568073|B4|Baseline|OPC 25mg|OPC, Opicapone 25mg
149634|NCT01568073|B3|Baseline|OPC 5mg|OPC, Opicapone 5mg
149635|NCT01568073|B2|Baseline|Entacapone|Entacapone - 200 mg
149636|NCT01568073|B1|Baseline|Placebo|Placebo 200 mg
149637|NCT01568073|P5|Participant Flow|OPC 50mg|OPC, Opicapone 50mg
149638|NCT01568073|P4|Participant Flow|OPC 25mg|OPC, Opicapone 25mg
149639|NCT01568073|P3|Participant Flow|OPC 5mg|OPC, Opicapone 5mg
149640|NCT01568073|P2|Participant Flow|Entacapone|Entacapone - 200 mg
149641|NCT01568073|P1|Participant Flow|Placebo|Placebo 200 mg
149642|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
149643|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
149644|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
149645|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
149646|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
149647|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
149648|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
149649|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
149650|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
149651|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
149652|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
149653|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
149654|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
149655|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
149656|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
149657|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
149658|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
149659|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
149660|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
149661|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
149662|NCT01568073|E5|Reported Event|OPC 50mg|OPC, Opicapone 50mg
149663|NCT01568073|E4|Reported Event|OPC 25mg|OPC, Opicapone 25mg
149664|NCT01568073|E3|Reported Event|OPC 5mg|OPC, Opicapone 5mg
149665|NCT01568073|E2|Reported Event|Entacapone|Entacapone - 200 mg
149666|NCT01568073|E1|Reported Event|Placebo|Placebo 200 mg
149667|NCT01568047|B5|Baseline|Total|Total of all reporting groups
149668|NCT01568047|B4|Baseline|BIA 9-1067 (30 mg)|30 mg BIA 9-1067 - OPC, Opicapone
149669|NCT01568047|B3|Baseline|BIA 9-1067 (15 mg)|15 mg BIA 9-1067 - OPC, Opicapone
149670|NCT01568047|B2|Baseline|BIA 9-1067 (5 mg)|5 mg BIA 9-1067 - OPC, Opicapone
149671|NCT01568047|B1|Baseline|Placebo|PLC, Placebo
149672|NCT01568047|P4|Participant Flow|BIA 9-1067 (30 mg)|OPC, Opicapone
149673|NCT01568047|P3|Participant Flow|BIA 9-1067 (15 mg)|OPC, Opicapone
149674|NCT01568047|P2|Participant Flow|BIA 9-1067 (5 mg)|OPC, Opicapone
149675|NCT01568047|P1|Participant Flow|Placebo|PLC, Placebo
149676|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
149677|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
149678|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
149679|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
149680|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
149681|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
149682|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
149683|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
149684|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
149685|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
149686|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
149687|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
149688|NCT01568047|E4|Reported Event|BIA 9-1067 (30 mg)|30 mg BIA 9-1067, OPC, Opicapone
149689|NCT01568047|E3|Reported Event|BIA 9-1067 (15 mg)|15 mg BIA 9-1067, OPC, Opicapone
149690|NCT01568047|E2|Reported Event|BIA 9-1067 (5 mg)|5 mg BIA 9-1067, OPC, Opicapone
149691|NCT01568047|E1|Reported Event|Placebo|Placebo, PLC
149692|NCT01568034|B1|Baseline|Overall Study|The study was to consist of four consecutive treatment periods, corresponding to the 4 different treatment options (25 mg, 50 mg and 100 mg BIA 9-1067or Placebo).According to randomisation, subjects were to receive, in a double-blind manner, 25, 50 and 100 mg BIA 9-1067 or Placebo at 4 separate treatment periods. Each subject were to receive each of the three BIA 9-1067 doses and Placebo in a random sequence with a 3:1 ratio (BIA 9-1067: Placebo) per treatment period.
149693|NCT01568034|P4|Participant Flow|Treatment Sequence D|"Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
149694|NCT01568034|P3|Participant Flow|Treatment Sequence C|"Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
149695|NCT01568034|P2|Participant Flow|Treatment Sequence B|"Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
150183|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
149696|NCT01568034|P1|Participant Flow|Treatment Sequence A|"Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
149697|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
149698|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
149699|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
149700|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
149701|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
149702|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
149703|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
149704|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
149705|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
149706|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
149707|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
149708|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
149709|NCT01568034|E4|Reported Event|Placebo|Placebo ESL, Eslicarbazepine
149710|NCT01568034|E3|Reported Event|100 mg BIA 9-1067|100 mg BIA 9-1067 ESL, Eslicarbazepine
149711|NCT01568034|E2|Reported Event|50 mg BIA 9-1067|50 mg BIA 9-1067 ESL, Eslicarbazepine
149712|NCT01568034|E1|Reported Event|25 mg BIA 9-1067|25 mg BIA 9-1067 ESL, Eslicarbazepine
149713|NCT01568021|B1|Baseline|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
149714|NCT01568021|P1|Participant Flow|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
149715|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
149716|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
149717|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
149718|NCT01568021|E1|Reported Event|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
149719|NCT01568008|B1|Baseline|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
149720|NCT01568008|P1|Participant Flow|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
149721|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
149722|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
149723|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
149724|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
149725|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
149726|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
149727|NCT01568008|E1|Reported Event|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
149728|NCT01567943|B3|Baseline|Total|Total of all reporting groups
149729|NCT01567943|B2|Baseline|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
149730|NCT01567943|B1|Baseline|Contingency Management|"Contingency Management plus treatment as usual
Contingency Management: Behavioral reinforcement for alcohol abstinence"
149731|NCT01567943|P3|Participant Flow|Pre-randomization Drop-out|These participants were enrolled/consented in the study but not randomized to the Contingency Management or Control conditions.
149732|NCT01567943|P2|Participant Flow|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
149733|NCT01567943|P1|Participant Flow|Contingency Management|"Contingency Management plus treatment as usual
Contingency Management: Behavioral reinforcement for alcohol abstinence"
149734|NCT01567943|O2|Outcome|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
149735|NCT01567943|O1|Outcome|Contingency Management|"Contingency Management plus treatment as usual
Contingency Management: Behavioral reinforcement for alcohol abstinence"
149736|NCT01567943|O2|Outcome|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
149737|NCT01567943|O1|Outcome|Contingency Management|"Contingency Management plus treatment as usual
Contingency Management: Behavioral reinforcement for alcohol abstinence"
149738|NCT01567943|E2|Reported Event|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
149739|NCT01567943|E1|Reported Event|Contingency Management|"Contingency Management plus treatment as usual
Contingency Management: Behavioral reinforcement for alcohol abstinence"
149740|NCT01567852|B3|Baseline|Total|Total of all reporting groups
149741|NCT01567852|B2|Baseline|Methohexital First|"This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.
Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect
Methohexital: Methohexital (1-1.5mg/kg) will be given for induction"
149782|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
149742|NCT01567852|B1|Baseline|Ketamine First|"This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine
Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect
Methohexital: Methohexital (1-1.5mg/kg) will be given for induction"
149743|NCT01567852|P2|Participant Flow|Methohexital Then Ketamine (Alternating Each Trial)|"This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital. Each induction is one trial. Each trial is followed by one day of no treatment (2 days for weekends).
Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect
Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect"
149744|NCT01567852|P1|Participant Flow|Ketamine Then Methohexital (Alternating Each Trial)|"This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine. Each induction is counted as one trial. Each trial is followed by a day of no treatment (2 days for weekends).
Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect
Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect"
149745|NCT01567852|O2|Outcome|Methohexital Inductions|Patients receiving methohexital for inductions
149746|NCT01567852|O1|Outcome|Ketamine Inductions|Patients receiving Ketamine inductions for ECT
149747|NCT01567852|O2|Outcome|Methohexital Inductions|Patients receiving methohexital for inductions
149748|NCT01567852|O1|Outcome|Ketamine Inductions|Patients receiving Ketamine inductions for ECT
149749|NCT01567852|E2|Reported Event|Methohexital Inductions|Number of trials receiving methohexital inductions. Each trial is one induction
149750|NCT01567852|E1|Reported Event|Ketamine Inductions|Number of trials receiving ketamine inductions. Each trial is one induction.
149751|NCT01567839|B1|Baseline|Subjects Receiving Injections|All subjects received each of the three anesthetic injections.
149752|NCT01567839|P1|Participant Flow|Subjects Receiving Injections|All subjects received each of the three anesthetic injections.
149753|NCT01567839|O3|Outcome|4% Prilocaine With 1:200,000 Epinephrine|
149754|NCT01567839|O2|Outcome|4% Lidocaine With 1:100,000 Epinephrine|
149755|NCT01567839|O1|Outcome|4% Articaine With 1:100,000 Epinephrine|
149756|NCT01567839|E3|Reported Event|4% Prilocaine With 1:200,000 Epinephrine|
149757|NCT01567839|E2|Reported Event|4% Lidocaine With 1:100,000 Epinephrine|
149758|NCT01567839|E1|Reported Event|4% Articaine With 1:100,000 Epinephrine|
149759|NCT01567826|B3|Baseline|Total|Total of all reporting groups
149760|NCT01567826|B2|Baseline|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
149761|NCT01567826|B1|Baseline|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
149762|NCT01567826|P2|Participant Flow|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
149763|NCT01567826|P1|Participant Flow|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
149764|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
149765|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
149766|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
149767|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
149768|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
149769|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
149770|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
149771|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
149772|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
149773|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
149774|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
149775|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
149776|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
149777|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
149778|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
149779|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
149780|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor
Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
149781|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
149903|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
149783|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor
standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
149784|NCT01567826|E2|Reported Event|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
149785|NCT01567826|E1|Reported Event|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
149786|NCT01567371|B1|Baseline|LiDCO Rapid Monitor|
149787|NCT01567371|P1|Participant Flow|LiDCO Rapid Monitor|
149788|NCT01567371|O1|Outcome|LiDCO Rapid Monitor|
149789|NCT01567371|O1|Outcome|LiDCO Rapid Monitor|
149790|NCT01567371|E1|Reported Event|LiDCO Rapid Monitor|
149791|NCT01567163|B1|Baseline|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle
Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
149792|NCT01567163|P1|Participant Flow|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle
Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
149793|NCT01567163|O1|Outcome|Ramucirumab|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion and followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
149794|NCT01567163|O1|Outcome|Ramucirumab|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
149795|NCT01567163|O1|Outcome|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle
Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
149796|NCT01567163|O1|Outcome|Docetaxel (Cycle 2)|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
149797|NCT01567163|O1|Outcome|Docetaxel (Cycle 1)|Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
149798|NCT01567163|O1|Outcome|Docetaxel (Cycle 2)|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion and followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
149799|NCT01567163|O1|Outcome|Docetaxel (Cycle 1)|Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
149800|NCT01567163|E1|Reported Event|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle
Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
149801|NCT01567150|B3|Baseline|Total|Total of all reporting groups
149802|NCT01567150|B2|Baseline|Control|Control is treatment without novel dressing
149803|NCT01567150|B1|Baseline|Novel Dressing|"Treatment with novel dressing
Novel Dressing: Topical wound dressing"
149804|NCT01567150|P2|Participant Flow|Control|Control is treatment without novel dressing
149805|NCT01567150|P1|Participant Flow|Novel Dressing|"Treatment with novel dressing
Novel Dressing: Topical wound dressing"
149806|NCT01567150|O2|Outcome|Control|Control is treatment without novel dressing
149807|NCT01567150|O1|Outcome|Novel Dressing|"Treatment with novel dressing
Novel Dressing: Topical wound dressing"
149808|NCT01567150|O2|Outcome|Control|Control is treatment without novel dressing
149809|NCT01567150|O1|Outcome|Novel Dressing|"Treatment with novel dressing
Novel Dressing: Topical wound dressing"
149810|NCT01567150|E2|Reported Event|Control|Control is treatment without novel dressing
149811|NCT01567150|E1|Reported Event|Novel Dressing|"Treatment with novel dressing
Novel Dressing: Topical wound dressing"
149812|NCT01567020|B5|Baseline|Total|Total of all reporting groups
149813|NCT01567020|B4|Baseline|Older|"Non-blast-exposed and non-TBI, aged 50 or older
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149814|NCT01567020|B3|Baseline|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149815|NCT01567020|B2|Baseline|Blast|"Blast-exposed with or without a TBI diagnosis
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149816|NCT01567020|B1|Baseline|Control|"Non-blast-exposed and non-TBI, aged younger than 50
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149817|NCT01567020|P4|Participant Flow|Older|"Non-blast-exposed and non-TBI, aged 50 or older
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149818|NCT01567020|P3|Participant Flow|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149819|NCT01567020|P2|Participant Flow|Blast|"Blast-exposed with or without a TBI diagnosis
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149820|NCT01567020|P1|Participant Flow|Control|"Non-blast-exposed and non-TBI, aged younger than 50
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149821|NCT01567020|O4|Outcome|Older|"Non-blast-exposed and non-TBI, aged 50 or older
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149822|NCT01567020|O3|Outcome|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149823|NCT01567020|O2|Outcome|Blast|"Blast-exposed with or without a TBI diagnosis
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149824|NCT01567020|O1|Outcome|Control|"Non-blast-exposed and non-TBI, aged younger than 50
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149825|NCT01567020|E4|Reported Event|Older|"Non-blast-exposed and non-TBI, aged 50 or older
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149826|NCT01567020|E3|Reported Event|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149827|NCT01567020|E2|Reported Event|Blast|"Blast-exposed with or without a TBI diagnosis
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149828|NCT01567020|E1|Reported Event|Control|"Non-blast-exposed and non-TBI, aged younger than 50
Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
149829|NCT01566981|B3|Baseline|Total|Total of all reporting groups
149830|NCT01566981|B2|Baseline|Diabetes Without Support|The group of randomly selected patients with DM type II, without software application and web-based support.
149831|NCT01566981|B1|Baseline|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients
Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process."
149832|NCT01566981|P2|Participant Flow|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.
8 patients were lost to follow up, so 54 patients were included in final analysis."
149833|NCT01566981|P1|Participant Flow|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients
Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.
5 patients were lost to follow up, consequently 53 patients were included in final analysis"
149834|NCT01566981|O2|Outcome|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.
8 patients were lost to follow and 54 patients were included in final analysis."
149835|NCT01566981|O1|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients
Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.
5 patients were lost to follow up, consequently 53 patients were included in final analysis"
149836|NCT01566981|O2|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients
Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process."
149837|NCT01566981|O1|Outcome|Diabetes Without Support|The group of randomly selected patients with DM type II, without software application and web-based support.
149838|NCT01566981|O2|Outcome|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.
8 patients were lost to follow and 54 patients were included in final analysis."
149839|NCT01566981|O1|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients
Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.
5 patients were lost to follow up, consequently 53 patients were included in final analysis"
149840|NCT01566981|E2|Reported Event|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.
8 patients were lost to follow up and 12 patients missed final consultation. 54 patients were included in final analysis."
149841|NCT01566981|E1|Reported Event|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients
Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.
5 patients were lost to follow up and 13 patients missed final consultation, consequently 53 patients were included in final analysis"
149842|NCT01566838|B3|Baseline|Total|Total of all reporting groups
149872|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
149904|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149843|NCT01566838|B2|Baseline|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management"
149844|NCT01566838|B1|Baseline|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
149845|NCT01566838|P2|Participant Flow|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management"
149846|NCT01566838|P1|Participant Flow|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Three patients did not have follow-up data for the study and were therefore excluded from analysis
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
149847|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management"
149848|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
149849|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management"
149873|NCT01566721|O3|Outcome|Cohort B: SC Herceptin by SID (Self-Administered)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
149905|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149850|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
149851|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management"
149852|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
149853|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management"
149854|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
149855|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management"
149856|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
149874|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
149875|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
149906|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
149857|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management"
149858|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
149859|NCT01566838|E2|Reported Event|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management"
149860|NCT01566838|E1|Reported Event|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
149861|NCT01566721|B3|Baseline|Total|Total of all reporting groups
149862|NCT01566721|B2|Baseline|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
149863|NCT01566721|B1|Baseline|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
149864|NCT01566721|P2|Participant Flow|Cohort B: SC Herceptin by Single-Use Injection Device (SID)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by a healthcare professional (HCP). Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
149865|NCT01566721|P1|Participant Flow|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 milligrams (mg) every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
149866|NCT01566721|O1|Outcome|Cohort B: SC Herceptin by SID (Self-Administered)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
149867|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
149868|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
149869|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
149870|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
149871|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
186721|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
149876|NCT01566721|O3|Outcome|Cohort B: SC Herceptin by SID (Self-Administered)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
149877|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
149878|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
149879|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
149880|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
149881|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
149882|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
149883|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
149884|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
149885|NCT01566721|E2|Reported Event|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
149886|NCT01566721|E1|Reported Event|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
149887|NCT01566630|B3|Baseline|Total|Total of all reporting groups
149888|NCT01566630|B2|Baseline|Placebo|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
149889|NCT01566630|B1|Baseline|RLX030|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
149890|NCT01566630|P2|Participant Flow|Placebo|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
149891|NCT01566630|P1|Participant Flow|RLX030|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
149892|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149893|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149894|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
149895|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
149896|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149897|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149898|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
149899|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
149900|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149901|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149986|NCT01566500|E1|Reported Event|Study Sample|Adults with self-reported epilepsy.
149908|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149909|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149910|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
149911|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
149912|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149913|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149914|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
149915|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
149916|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
149917|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
149918|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
149919|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
149920|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149921|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149922|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149923|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149924|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149925|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149926|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
149927|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
149928|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149929|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149930|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149931|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149932|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149933|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149934|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149935|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149936|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
149937|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
150105|NCT01566149|B3|Baseline|Total|Total of all reporting groups
150372|NCT01565551|B3|Baseline|Total|Total of all reporting groups
149938|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149939|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149940|NCT01566630|E4|Reported Event|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
149941|NCT01566630|E3|Reported Event|Placebo- Maternal|Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
149942|NCT01566630|E2|Reported Event|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
149943|NCT01566630|E1|Reported Event|RLX030- Maternal|Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
149944|NCT01566604|B3|Baseline|Total|Total of all reporting groups
149945|NCT01566604|B2|Baseline|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149946|NCT01566604|B1|Baseline|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149947|NCT01566604|P2|Participant Flow|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149948|NCT01566604|P1|Participant Flow|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149949|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149950|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149951|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149952|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149953|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149954|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149955|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149956|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149957|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149958|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149959|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149960|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149961|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149962|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149963|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149964|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149965|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149966|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149967|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149968|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149969|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149970|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149971|NCT01566604|E2|Reported Event|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
149972|NCT01566604|E1|Reported Event|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
149973|NCT01566526|B1|Baseline|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
149974|NCT01566526|P1|Participant Flow|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
149975|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
149976|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
149977|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
149978|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
149979|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
149980|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
149981|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
149982|NCT01566526|E1|Reported Event|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
149983|NCT01566500|B1|Baseline|Study Sample|Adults with self-reported epilepsy.
149984|NCT01566500|P1|Participant Flow|Study Sample|Adults with self-reported epilepsy.
149985|NCT01566500|O1|Outcome|Study Sample|Adults with self-reported epilepsy.
149987|NCT01566461|B3|Baseline|Total|Total of all reporting groups
149988|NCT01566461|B2|Baseline|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
149989|NCT01566461|B1|Baseline|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
149990|NCT01566461|P2|Participant Flow|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
149991|NCT01566461|P1|Participant Flow|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
149992|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
149993|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
149994|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
149995|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
149996|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
149997|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
149998|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
149999|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150000|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150001|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150002|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150003|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150004|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150005|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150006|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150007|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150008|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150009|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150010|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150011|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150012|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150013|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150014|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150015|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150016|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150017|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150018|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150019|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150020|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150021|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150022|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150023|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150024|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150025|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150026|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150027|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150028|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150029|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150030|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150031|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
150032|NCT01566461|E2|Reported Event|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
150033|NCT01566461|E1|Reported Event|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
150034|NCT01566435|B1|Baseline|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
Cisplatin 75 mg/m2 on Day 1
5-FU 750 mg/m2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.
Definitive Therapy
Cisplatin 100 mg/m2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
150035|NCT01566435|P1|Participant Flow|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15
Cisplatin 75 mg/m^2 on Day 1
5-FU 750 mg/m^2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.
Definitive Therapy
Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m^2 IV week for 8 weeks"
150066|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150067|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150068|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150036|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
Cisplatin 75 mg/m2 on Day 1
5-FU 750 mg/m2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.
Definitive Therapy
Cisplatin 100 mg/m2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
150037|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
Cisplatin 75 mg/m2 on Day 1
5-FU 750 mg/m2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.
Definitive Therapy
Cisplatin 100 mg/m2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
150038|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
Cisplatin 75 mg/m2 on Day 1
5-FU 750 mg/m2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.
Definitive Therapy
Cisplatin 100 mg/m2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
150039|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
Cisplatin 75 mg/m2 on Day 1
5-FU 750 mg/m2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.
Definitive Therapy
Cisplatin 100 mg/m2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
150040|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
Cisplatin 75 mg/m2 on Day 1
5-FU 750 mg/m2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.
Definitive Therapy
Cisplatin 100 mg/m2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
150041|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
Cisplatin 75 mg/m2 on Day 1
5-FU 750 mg/m2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.
Definitive Therapy
Cisplatin 100 mg/m2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
150042|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
Cisplatin 75 mg/m2 on Day 1
5-FU 750 mg/m2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.
Definitive Therapy
Cisplatin 100 mg/m2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
150043|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
Cisplatin 75 mg/m2 on Day 1
5-FU 750 mg/m2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.
Definitive Therapy
Cisplatin 100 mg/m2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
186722|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
150044|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
Cisplatin 75 mg/m2 on Day 1
5-FU 750 mg/m2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.
Definitive Therapy
Cisplatin 100 mg/m2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
150045|NCT01566435|E3|Reported Event|ACF Definitive Chemoradiation Therapy-cetuximab|"Definitive Therapy
Cetuximab 250 mg/m^2 IV weekly for 8 weeks
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions."
150046|NCT01566435|E2|Reported Event|ACF Definitive Chemoradiation Therapy-cisplatin|"Definitive Therapy
Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43
Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions."
150047|NCT01566435|E1|Reported Event|ACF Induction Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)
nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15
Cisplatin 75 mg/m^2 on Day 1
5-FU 750 mg/m^2 on Days 1-3
If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF."
150048|NCT01566409|B3|Baseline|Total|Total of all reporting groups
150049|NCT01566409|B2|Baseline|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
150050|NCT01566409|B1|Baseline|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
150051|NCT01566409|P2|Participant Flow|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
150052|NCT01566409|P1|Participant Flow|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
150053|NCT01566409|O2|Outcome|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
150054|NCT01566409|O1|Outcome|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
150055|NCT01566409|E2|Reported Event|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
150056|NCT01566409|E1|Reported Event|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
150057|NCT01566370|B3|Baseline|Total|Total of all reporting groups
150058|NCT01566370|B2|Baseline|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150059|NCT01566370|B1|Baseline|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150060|NCT01566370|P2|Participant Flow|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150061|NCT01566370|P1|Participant Flow|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150062|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150063|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150064|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150065|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150069|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150070|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150071|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150072|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150073|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150074|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150075|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150076|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150077|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150078|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150079|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150080|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150081|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150082|NCT01566370|E2|Reported Event|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo"
150083|NCT01566370|E1|Reported Event|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
150084|NCT01566331|B3|Baseline|Total|Total of all reporting groups
150085|NCT01566331|B2|Baseline|Baby-guardTM With Minimal Inflation|Baby-guardTM system, with minimal inflation in women who expected natural delivery
150086|NCT01566331|B1|Baseline|Baby-guardTM|Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes
150087|NCT01566331|P2|Participant Flow|Baby-guardTM Minimal Inflation|Baby-guardTM with minimal inflation who expected natural delivery
150088|NCT01566331|P1|Participant Flow|Baby-guardTM|"Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes
Baby-guardTM: Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes"
150089|NCT01566331|O2|Outcome|Baby-guardTM With Minimal Inflation|
150090|NCT01566331|O1|Outcome|Baby Belt Device Group|
150091|NCT01566331|E2|Reported Event|Baby Birth With Minimal Inflation|group delivering with dwvice and minimal inflation
150092|NCT01566331|E1|Reported Event|Baby Birth|group delivering with baby birth
150093|NCT01566162|B1|Baseline|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
150094|NCT01566162|P1|Participant Flow|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
150095|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
150096|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
150097|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
150098|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
150099|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
150100|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
150101|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
150102|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose
Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
150107|NCT01566149|B1|Baseline|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
150108|NCT01566149|P2|Participant Flow|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
150109|NCT01566149|P1|Participant Flow|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
150110|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
150111|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
150112|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
150113|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
150114|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
150115|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
150116|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
150117|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
150118|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
150119|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
150120|NCT01566149|E2|Reported Event|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
150121|NCT01566149|E1|Reported Event|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
150122|NCT01566084|B3|Baseline|Total|Total of all reporting groups
150123|NCT01566084|B2|Baseline|Placebo (Start)|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
Subjects then cross over to the slow sodium tablet arm in the second half of the study."
150124|NCT01566084|B1|Baseline|Slow Sodium Tablets (Start)|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a slow sodium tablets to bring them back up to a normal salt intake. This is administered through 10 tablets day.
Subjects then cross-over to the placebo arm in the second half of the study."
150125|NCT01566084|P2|Participant Flow|Placebo|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
Subjects then cross over to the opposite condition in the second half of the study."
150126|NCT01566084|P1|Participant Flow|Slow Sodium Tablets (Start)|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
Subjects then cross over to the opposite condition in the second half of the study."
150127|NCT01566084|O4|Outcome|Low Sodium BH4|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
150128|NCT01566084|O3|Outcome|Normal Sodium BH4|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
150129|NCT01566084|O2|Outcome|Low Sodium Placebo|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
150130|NCT01566084|O1|Outcome|Normal Sodium Placebo|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
150131|NCT01566084|O4|Outcome|Low Sodium Ascorbic Acid|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
150132|NCT01566084|O3|Outcome|Normal Sodium Ascorbic Acid|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
150133|NCT01566084|O2|Outcome|Low Sodium Saline|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
150134|NCT01566084|O1|Outcome|Normal Sodium Saline|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
150135|NCT01566084|O2|Outcome|Low Sodium Diet.|Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
150136|NCT01566084|O1|Outcome|Normal Sodium Diet|Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a salt pill to bring them back up to a normal salt intake.
150137|NCT01566084|E2|Reported Event|Low Sodium|Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
150138|NCT01566084|E1|Reported Event|Normal Sodium|Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
150139|NCT01565993|B3|Baseline|Total|Total of all reporting groups
150179|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150140|NCT01565993|B2|Baseline|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
150141|NCT01565993|B1|Baseline|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
154344|NCT01545700|O7|Outcome|Dexamethasone 4 mg 0-4 Hours-1 Hour|
150142|NCT01565993|P2|Participant Flow|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
150143|NCT01565993|P1|Participant Flow|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
150144|NCT01565993|O2|Outcome|Conventional Polipectomy|In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique.Disposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection.
150145|NCT01565993|O1|Outcome|Hemoclip|"In group HEMOCLIP, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop. In all the polypectomies that were assigned to group HEMOCLIP, a rotatable clip-fixing device Quickclip 2 standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm"
150146|NCT01565993|E2|Reported Event|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
150147|NCT01565993|E1|Reported Event|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
150148|NCT01565980|B3|Baseline|Total|Total of all reporting groups
150149|NCT01565980|B2|Baseline|Mindfulness Intervention|"Participants receive weekly symptom assessment phone calls.
Mindfulness Intervention: Participants receive 6 weekly sessions of a home delivered mindfulness intervention."
150150|NCT01565980|B1|Baseline|Attention Control|weekly symptom assessment phone calls.
150151|NCT01565980|P2|Participant Flow|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.
Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.
Participants also receive weekly symptom assessment phone interview."
150152|NCT01565980|P1|Participant Flow|Symptom Assessment|"weekly phone calls.
symptom assessment: attention control group"
150153|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.
Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.
Participants also receive weekly symptom assessment phone interview."
150154|NCT01565980|O1|Outcome|Symptom Assessment|"weekly phone calls.
symptom assessment: attention control group"
150155|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.
symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks.
Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks."
150156|NCT01565980|O1|Outcome|Symptom Assessment|"6 weeks of symptom assessment phone calls.
symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks."
150157|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms."
150158|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.
symptom assessment interview."
150159|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms."
150160|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.
symptom assessment interview."
150161|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms."
150162|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.
symptom assessment interview."
150163|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms."
150164|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.
symptom assessment interview."
150165|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms."
150166|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.
symptom assessment interview."
150167|NCT01565980|E2|Reported Event|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.
Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention."
150168|NCT01565980|E1|Reported Event|Symptom Assessment|"weekly phone calls.
symptom assessment: attention control group"
150169|NCT01565902|B5|Baseline|Total|Total of all reporting groups
150170|NCT01565902|B4|Baseline|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
150171|NCT01565902|B3|Baseline|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150172|NCT01565902|B2|Baseline|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150173|NCT01565902|B1|Baseline|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150174|NCT01565902|P4|Participant Flow|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
150175|NCT01565902|P3|Participant Flow|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150176|NCT01565902|P2|Participant Flow|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150177|NCT01565902|P1|Participant Flow|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150178|NCT01565902|O4|Outcome|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
150184|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
150185|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150186|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150187|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150188|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
150189|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
150190|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
150191|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150192|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150193|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150194|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
150195|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
150196|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
150197|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150198|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150199|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150200|NCT01565902|E4|Reported Event|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150201|NCT01565902|E3|Reported Event|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
150202|NCT01565902|E2|Reported Event|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150203|NCT01565902|E1|Reported Event|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
150204|NCT01565889|B7|Baseline|Total|Total of all reporting groups
150205|NCT01565889|B6|Baseline|Part B: SOF+PEG+RBV|"SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
This reporting group presents data for those participants who joined the study for Part B only."
150206|NCT01565889|B5|Baseline|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
150207|NCT01565889|B4|Baseline|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150208|NCT01565889|B3|Baseline|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150209|NCT01565889|B2|Baseline|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
150210|NCT01565889|B1|Baseline|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
150211|NCT01565889|P6|Participant Flow|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + pegylated interferon alpha (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
150212|NCT01565889|P5|Participant Flow|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + raltegravir (RAL) 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
150213|NCT01565889|P4|Participant Flow|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + darunavir (DRV; 800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150214|NCT01565889|P3|Participant Flow|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + atazanavir (ATV) 400 mg tablet boosted with ritonavir (RTV) 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150215|NCT01565889|P2|Participant Flow|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
150216|NCT01565889|P1|Participant Flow|Part A: SOF+EFV/FTC/TDF (Cohort 1)|Sofosbuvir (SOF; 1 × 400 mg tablet or 2 × 200 mg tablets) + efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
150217|NCT01565889|O6|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
150218|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
150447|NCT01565343|E1|Reported Event|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
150219|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150220|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150221|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
150222|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
150223|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
150224|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
150225|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
150226|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
150227|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
150228|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
150229|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150230|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150231|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
150232|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
150233|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
150234|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150235|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150236|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
150237|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
150238|NCT01565889|E6|Reported Event|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
150239|NCT01565889|E5|Reported Event|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
150240|NCT01565889|E4|Reported Event|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150241|NCT01565889|E3|Reported Event|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
150242|NCT01565889|E2|Reported Event|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
150243|NCT01565889|E1|Reported Event|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
150244|NCT01565850|B3|Baseline|Total|Total of all reporting groups
154345|NCT01545700|O6|Outcome|Dexamethasone 4 mg 0-4 Hours-baseline|
150245|NCT01565850|B2|Baseline|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
150246|NCT01565850|B1|Baseline|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
150247|NCT01565850|P2|Participant Flow|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
150248|NCT01565850|P1|Participant Flow|D/C/F/TAF|Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) (800/150/200/10 mg) fixed-dose combination (FDC) tablet plus darunavir (DRV) placebo plus cobicistat (COBI) placebo plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily
150249|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
150250|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
150251|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
150252|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
150253|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
150254|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
150255|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
150256|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
150257|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
150258|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
150259|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
150260|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
150261|NCT01565850|E2|Reported Event|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
150262|NCT01565850|E1|Reported Event|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
150263|NCT01565707|B5|Baseline|Total|Total of all reporting groups
150264|NCT01565707|B4|Baseline|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150265|NCT01565707|B3|Baseline|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150266|NCT01565707|B2|Baseline|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150267|NCT01565707|B1|Baseline|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150268|NCT01565707|P4|Participant Flow|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150269|NCT01565707|P3|Participant Flow|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150270|NCT01565707|P2|Participant Flow|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150271|NCT01565707|P1|Participant Flow|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150272|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150273|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150274|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150275|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150276|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150277|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150278|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150279|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150280|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150281|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150282|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150283|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150284|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
150285|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150286|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150287|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150288|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150289|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
150290|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150291|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150292|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150293|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150294|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
150295|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150296|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150297|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150298|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150299|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
150300|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150301|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150302|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150303|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150304|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
150305|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150306|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150307|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150308|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150309|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
150310|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150311|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
150312|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150313|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
150314|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
150315|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150316|NCT01565707|O1|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150317|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150318|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150319|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150320|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150321|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150322|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150323|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150324|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150325|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150326|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150327|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150328|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150329|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150330|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150331|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150332|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150333|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150334|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150335|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150336|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150337|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150338|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150339|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150340|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150341|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150342|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150343|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150344|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150345|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150346|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150347|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150348|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150349|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150350|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150351|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150352|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150353|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150354|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
150355|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
150356|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
150357|NCT01565707|E4|Reported Event|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks.
150358|NCT01565707|E3|Reported Event|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo oral suspension once a day for 12 weeks.
150359|NCT01565707|E2|Reported Event|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks.
150360|NCT01565707|E1|Reported Event|Placebo Children|Children aged 5 to 11 years received matching placebo oral suspension once a day for 12 weeks.
150361|NCT01565564|B3|Baseline|Total|Total of all reporting groups
150362|NCT01565564|B2|Baseline|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
Self blood glucose monitoring
Insulin therapy if indicated
Self blood glucose monitoring
Insulin therapy institutions if indicated;"
150363|NCT01565564|B1|Baseline|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
Self blood glucose monitoring
Insulin therapy if indicated
Self blood glucose monitoring
Insulin therapy institutions if indicated;"
150364|NCT01565564|P2|Participant Flow|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
Self blood glucose monitoring
Insulin therapy if indicated
Self blood glucose monitoring
Insulin therapy institutions if indicated;"
150365|NCT01565564|P1|Participant Flow|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
Self blood glucose monitoring
Insulin therapy if indicated
Self blood glucose monitoring
Insulin therapy institutions if indicated;"
150366|NCT01565564|O2|Outcome|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
Self blood glucose monitoring
Insulin therapy if indicated
Self blood glucose monitoring
Insulin therapy institutions if indicated;"
150367|NCT01565564|O1|Outcome|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
Self blood glucose monitoring
Insulin therapy if indicated
Self blood glucose monitoring
Insulin therapy institutions if indicated;"
150368|NCT01565564|O2|Outcome|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
Self blood glucose monitoring
Insulin therapy if indicated
Self blood glucose monitoring
Insulin therapy institutions if indicated;"
150369|NCT01565564|O1|Outcome|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
Self blood glucose monitoring
Insulin therapy if indicated
Self blood glucose monitoring
Insulin therapy institutions if indicated;"
150370|NCT01565564|E2|Reported Event|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
Self blood glucose monitoring
Insulin therapy if indicated
Self blood glucose monitoring
Insulin therapy institutions if indicated;"
150407|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
150371|NCT01565564|E1|Reported Event|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education
Self blood glucose monitoring
Insulin therapy if indicated
Self blood glucose monitoring
Insulin therapy institutions if indicated;"
150373|NCT01565551|B2|Baseline|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).
N/A (Observational Study): No Interventions: Observational Study"
150374|NCT01565551|B1|Baseline|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).
N/A (Observational Study): No Interventions: Observational Study"
150375|NCT01565551|P2|Participant Flow|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).
N/A (Observational Study): No Interventions: Observational Study"
150376|NCT01565551|P1|Participant Flow|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).
N/A (Observational Study): No Interventions: Observational Study"
150377|NCT01565551|O2|Outcome|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).
N/A (Observational Study): No Interventions: Observational Study"
150378|NCT01565551|O1|Outcome|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).
N/A (Observational Study): No Interventions: Observational Study"
150379|NCT01565551|E2|Reported Event|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).
N/A (Observational Study): No Interventions: Observational Study"
150380|NCT01565551|E1|Reported Event|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).
N/A (Observational Study): No Interventions: Observational Study"
150381|NCT01565538|B3|Baseline|Total|Total of all reporting groups
150382|NCT01565538|B2|Baseline|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV"
150383|NCT01565538|B1|Baseline|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally"
150384|NCT01565538|P2|Participant Flow|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV"
150385|NCT01565538|P1|Participant Flow|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally"
150386|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV"
150387|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally"
150388|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV"
150389|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally"
150390|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV"
150391|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally"
150392|NCT01565538|E2|Reported Event|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Pemetrexed: 500mg/m2 Given IV"
150393|NCT01565538|E1|Reported Event|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.
Erlotinib: 150 mg Given orally"
150394|NCT01563406|B5|Baseline|Total|Total of all reporting groups
150395|NCT01563406|B4|Baseline|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
150396|NCT01563406|B3|Baseline|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
150397|NCT01563406|B2|Baseline|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
150398|NCT01563406|B1|Baseline|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
150399|NCT01563406|P4|Participant Flow|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
150400|NCT01563406|P3|Participant Flow|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
150401|NCT01563406|P2|Participant Flow|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
150402|NCT01563406|P1|Participant Flow|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
150403|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.
150404|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
150405|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.
150406|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.
150448|NCT01565330|B5|Baseline|Total|Total of all reporting groups
150408|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
150409|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
150410|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
150411|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.
150412|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
150413|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.
150414|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.
150415|NCT01563406|E4|Reported Event|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
150416|NCT01563406|E3|Reported Event|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
150417|NCT01563406|E2|Reported Event|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
150418|NCT01563406|E1|Reported Event|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
150419|NCT01565382|B1|Baseline|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
150420|NCT01565382|P2|Participant Flow|Physicians|Private nuclear medicine physicians with no previous training in reading florbetapir scans.
150421|NCT01565382|P1|Participant Flow|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
150422|NCT01565382|O1|Outcome|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
150423|NCT01565382|O1|Outcome|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05(NCT00702143)
150424|NCT01565382|E1|Reported Event|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
150425|NCT01565369|B1|Baseline|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
150426|NCT01565369|P1|Participant Flow|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
150427|NCT01565369|O1|Outcome|All A07(NCT00857415) Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
150428|NCT01565369|O1|Outcome|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
150429|NCT01565369|O1|Outcome|All A07(NCT00857415) Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
150430|NCT01565369|E1|Reported Event|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
150431|NCT01565356|B1|Baseline|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
150432|NCT01565356|P1|Participant Flow|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
150433|NCT01565356|O1|Outcome|All Scans|22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)
150434|NCT01565356|O1|Outcome|All Scans|22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)
150435|NCT01565356|E1|Reported Event|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
150436|NCT01565343|B4|Baseline|Total|Total of all reporting groups
150437|NCT01565343|B3|Baseline|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
150438|NCT01565343|B2|Baseline|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
150439|NCT01565343|B1|Baseline|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
150440|NCT01565343|P3|Participant Flow|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
150441|NCT01565343|P2|Participant Flow|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
150442|NCT01565343|P1|Participant Flow|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
150443|NCT01565343|O2|Outcome|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
150444|NCT01565343|O1|Outcome|AD Subjects|Male or female subjects > 50 years old; probable Alzheimer's Disease) AD according to National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria; Mini-Mental State Examination (MMSE) 10-24
150445|NCT01565343|E3|Reported Event|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
150446|NCT01565343|E2|Reported Event|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
150449|NCT01565330|B4|Baseline|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
150450|NCT01565330|B3|Baseline|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
150451|NCT01565330|B2|Baseline|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
150452|NCT01565330|B1|Baseline|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
150453|NCT01565330|P4|Participant Flow|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
150454|NCT01565330|P3|Participant Flow|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
150455|NCT01565330|P2|Participant Flow|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
150456|NCT01565330|P1|Participant Flow|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
150457|NCT01565330|O4|Outcome|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
150458|NCT01565330|O3|Outcome|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
150459|NCT01565330|O2|Outcome|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
150460|NCT01565330|O1|Outcome|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
150461|NCT01565330|O4|Outcome|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
150462|NCT01565330|O3|Outcome|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
150463|NCT01565330|O2|Outcome|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
150464|NCT01565330|O1|Outcome|111 MBq (3 mCi) AD Group|Subjects with Alzheimer's Disease (AD) who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
150465|NCT01565330|E4|Reported Event|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
150466|NCT01565330|E3|Reported Event|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
150467|NCT01565330|E2|Reported Event|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
150468|NCT01565330|E1|Reported Event|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
150469|NCT01565291|B3|Baseline|Total|Total of all reporting groups
150470|NCT01565291|B2|Baseline|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
150471|NCT01565291|B1|Baseline|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
150472|NCT01565291|P2|Participant Flow|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
150473|NCT01565291|P1|Participant Flow|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
150474|NCT01565291|O2|Outcome|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
150475|NCT01565291|O1|Outcome|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
150476|NCT01565291|O2|Outcome|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
150477|NCT01565291|O1|Outcome|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
150478|NCT01565291|E2|Reported Event|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
150479|NCT01565291|E1|Reported Event|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
150480|NCT01565148|B5|Baseline|Total|Total of all reporting groups
150481|NCT01565148|B4|Baseline|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
150482|NCT01565148|B3|Baseline|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
150483|NCT01565148|B2|Baseline|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
150484|NCT01565148|B1|Baseline|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
150485|NCT01565148|P4|Participant Flow|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
150486|NCT01565148|P3|Participant Flow|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
150487|NCT01565148|P2|Participant Flow|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
150579|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150488|NCT01565148|P1|Participant Flow|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
150587|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150489|NCT01565148|O4|Outcome|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
150490|NCT01565148|O3|Outcome|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
150491|NCT01565148|O2|Outcome|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
150492|NCT01565148|O1|Outcome|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
150493|NCT01565148|O4|Outcome|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
150494|NCT01565148|O3|Outcome|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
150495|NCT01565148|O2|Outcome|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
150496|NCT01565148|O1|Outcome|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
150497|NCT01565148|O4|Outcome|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
150498|NCT01565148|O3|Outcome|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
150499|NCT01565148|O2|Outcome|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
150500|NCT01565148|O1|Outcome|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
150501|NCT01565148|O4|Outcome|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
150502|NCT01565148|O3|Outcome|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
150503|NCT01565148|O2|Outcome|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
150504|NCT01565148|O1|Outcome|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
150505|NCT01565148|O4|Outcome|Ranibizumab and iCo-007 350 mcg|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
150506|NCT01565148|O3|Outcome|iCo-007 350 mcg and Laser|iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
150507|NCT01565148|O2|Outcome|iCo-007 700 mcg|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
150508|NCT01565148|O1|Outcome|iCo-007 350 mcg|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
150509|NCT01565148|O4|Outcome|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
150510|NCT01565148|O3|Outcome|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
150511|NCT01565148|O2|Outcome|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
150512|NCT01565148|O1|Outcome|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
150513|NCT01565148|O4|Outcome|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
150514|NCT01565148|O3|Outcome|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
150515|NCT01565148|O2|Outcome|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
150516|NCT01565148|O1|Outcome|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
150517|NCT01565148|E4|Reported Event|Group 4|Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
150518|NCT01565148|E3|Reported Event|Group 3|iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
150519|NCT01565148|E2|Reported Event|Group 2|iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
150520|NCT01565148|E1|Reported Event|Group 1|iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
150521|NCT01565083|B3|Baseline|Total|Total of all reporting groups
150522|NCT01565083|B2|Baseline|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150523|NCT01565083|B1|Baseline|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150524|NCT01565083|P2|Participant Flow|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150525|NCT01565083|P1|Participant Flow|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg per kilogram (mg/kg) on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg per meter-squared (mg/m^2) on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150526|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150527|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150528|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150580|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150581|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150582|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150588|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150529|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150530|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150531|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150532|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150533|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150534|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150535|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150536|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150537|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150583|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150584|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
186723|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
150538|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150539|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150540|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150541|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150542|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150543|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150544|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150545|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150546|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150585|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150586|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
151811|NCT01559311|B1|Baseline|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
150547|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150548|NCT01565083|E2|Reported Event|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150549|NCT01565083|E1|Reported Event|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
150550|NCT01564953|B1|Baseline|Serum Vitamin D, Magnesium and Calcium Deficient Groups|Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
150551|NCT01564953|P1|Participant Flow|Serum Vitamin D, Magnesium and Calcium Deficient Groups|Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
150552|NCT01564953|O1|Outcome|Quality of Life|Quality of life measured by Chronic Obstructive Pulmonary Disease Assesment Test
150553|NCT01564953|O1|Outcome|Serum Calcium|Serum ionized calcium, in mmol/L
150554|NCT01564953|O1|Outcome|Serum Magnesium|Serum magnesium in plasma, in mmol/L
150555|NCT01564953|O1|Outcome|Lung Function|lung function measured as forced expiratory volumes in 1 second.
150556|NCT01564953|O1|Outcome|Serum Vitamin D|Participants' serum vitamin D
150557|NCT01564953|E1|Reported Event||Adverse Events were not collected for the 143 participants
150558|NCT01564862|B4|Baseline|Total|Total of all reporting groups
150559|NCT01564862|B3|Baseline|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150560|NCT01564862|B2|Baseline|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150561|NCT01564862|B1|Baseline|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150562|NCT01564862|P3|Participant Flow|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150563|NCT01564862|P2|Participant Flow|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150564|NCT01564862|P1|Participant Flow|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150565|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150566|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150567|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150568|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150569|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150570|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150571|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150572|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150573|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150574|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150575|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150576|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150577|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150578|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
187499|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
150589|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150590|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150591|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150592|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150593|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150594|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150595|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150596|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150597|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150598|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150599|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150600|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150601|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150602|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150603|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150604|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150605|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150606|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150607|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150608|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150609|NCT01564862|E3|Reported Event|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
150610|NCT01564862|E2|Reported Event|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
150611|NCT01564862|E1|Reported Event|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
150612|NCT01564758|B1|Baseline|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
150613|NCT01564758|P1|Participant Flow|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
150614|NCT01564758|O1|Outcome|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
150615|NCT01564758|O1|Outcome|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
150616|NCT01564758|E1|Reported Event|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
150617|NCT01564732|B3|Baseline|Total|Total of all reporting groups
150618|NCT01564732|B2|Baseline|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.
Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
150645|NCT01564693|P2|Participant Flow|NON-ANOREXIC CANCER PATIENTS|According to the protocol, we evaluated 4 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the absence of anorexia was assessed by appetite assessment tools.
150649|NCT01564693|O1|Outcome|ANOREXIC CANCER PATIENTS|Patients revealed as anorexic were studied regarding BOLD signal activity by fMRI
150710|NCT01564407|P1|Participant Flow|No Injection|Safety cohort. 4 subjects received empty control. No injection
150711|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
150619|NCT01564732|B1|Baseline|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.
Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
150620|NCT01564732|P2|Participant Flow|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.
Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
150621|NCT01564732|P1|Participant Flow|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.
Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
150622|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.
Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
150623|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.
Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
150624|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.
Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
150625|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.
Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
150626|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.
Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
150627|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.
Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
150646|NCT01564693|P1|Participant Flow|ANOREXIC CANCER PATIENTS|We evaluated 9 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the presence of anorexia was assessed by appetite assessment tools.
150647|NCT01564693|O3|Outcome|CONTROL GROUP|Healthy subjects were studied regarding BOLD signal activity by fMRI
150648|NCT01564693|O2|Outcome|NON-ANOREXIC CANCER PATIENTS|Patients revealed as non-anorexic were studied regarding BOLD signal activity by fMRI
151812|NCT01559311|P3|Participant Flow|DDDR|Control Group – DDDR Standard Therapy
150628|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.
Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
150629|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.
Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
150630|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.
Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
150631|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.
Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
150632|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.
Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
150633|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.
Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
150634|NCT01564732|E2|Reported Event|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.
Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
150635|NCT01564732|E1|Reported Event|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.
Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
150636|NCT01564706|B1|Baseline|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
150637|NCT01564706|P1|Participant Flow|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
150638|NCT01564706|O1|Outcome|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
150639|NCT01564706|E1|Reported Event|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
150640|NCT01564693|B4|Baseline|Total|Total of all reporting groups
150641|NCT01564693|B3|Baseline|CONTROL GROUP|These were healthy subjects. 1 MD working at the Oncology Dept. , 1 family member of one of the patients enrolled.
150642|NCT01564693|B2|Baseline|NON-ANOREXIC CANCER PATIENTS|Based on the anorexia instruments that we used, we considered these patients as non-anorexic
150643|NCT01564693|B1|Baseline|ANOREXIC CANCER PATIENTS|Based on the anorexia instruments that we used, we considered these patients as anorexic.
150644|NCT01564693|P3|Participant Flow|CONTROL GROUP|Two healthy volunteers were evaluated and included in the study as controls. Their appetite was normal, as assessed by appetite measurement tools.
152958|NCT01553708|B1|Baseline|Epidermal Growth Factor With Silver Sulfadiazine Cream|
150650|NCT01564693|E3|Reported Event|CONTROL GROUP|Two volunteers were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
150651|NCT01564693|E2|Reported Event|NON-ANOREXIC CANCER PATIENTS|Four patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
150652|NCT01564693|E1|Reported Event|ANOREXIC CANCER PATIENTS|Nine patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
150653|NCT01564537|B3|Baseline|Total|Total of all reporting groups
150654|NCT01564537|B2|Baseline|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150655|NCT01564537|B1|Baseline|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150656|NCT01564537|P2|Participant Flow|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150657|NCT01564537|P1|Participant Flow|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to end of treatment (EOT) projected at 80 months.
150658|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150659|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150660|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150661|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150662|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150663|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150664|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150665|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150666|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150667|NCT01564537|O1|Outcome|Ixazomib + Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150668|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150708|NCT01564407|P3|Participant Flow|Single Admin Drug Day 0|Single administration of study drug on day 0
150669|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150670|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150671|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150672|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150673|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150674|NCT01564537|E2|Reported Event|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
150675|NCT01564537|E1|Reported Event|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity up to EOT projected at 80 months.
150676|NCT01564459|B4|Baseline|Total|Total of all reporting groups
150677|NCT01564459|B3|Baseline|MK-6096 10 mg→Placebo|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
150678|NCT01564459|B2|Baseline|MK-6096 10 mg→MK-6096 10 mg|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period
150679|NCT01564459|B1|Baseline|MK-6096 10 mg→No Treatment|Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
150680|NCT01564459|P3|Participant Flow|MK-6096 10 mg→Placebo|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
150681|NCT01564459|P2|Participant Flow|MK-6096 10 mg→MK-6096 10 mg|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period.
150682|NCT01564459|P1|Participant Flow|MK-6096 10 mg→No Treatment|Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
150683|NCT01564459|O3|Outcome|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
150684|NCT01564459|O2|Outcome|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
150685|NCT01564459|O1|Outcome|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
150686|NCT01564459|O3|Outcome|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
150687|NCT01564459|O2|Outcome|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
150688|NCT01564459|O1|Outcome|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
150689|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
150690|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
150691|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
150692|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
150693|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
150694|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
150695|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
150696|NCT01564459|O1|Outcome|MK-6096|Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
150697|NCT01564459|E3|Reported Event|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
150698|NCT01564459|E2|Reported Event|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
150699|NCT01564459|E1|Reported Event|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
150700|NCT01564407|B6|Baseline|Total|Total of all reporting groups
150701|NCT01564407|B5|Baseline|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
150702|NCT01564407|B4|Baseline|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
150703|NCT01564407|B3|Baseline|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
150704|NCT01564407|B2|Baseline|Vehicle Only|Vehicle only (0.5 ml of HypoThermosol solution)
150705|NCT01564407|B1|Baseline|No Injection|Empty safety control, no injection
150706|NCT01564407|P5|Participant Flow|Admin Drug Day 0 and 28|Single administration day 0 and 28
150707|NCT01564407|P4|Participant Flow|Single Admin Drug Day 28|Single administration on Day 28
150713|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
150714|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
150715|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
150716|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
150717|NCT01564407|O4|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
150718|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
150719|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
150720|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
150721|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
150722|NCT01564407|O4|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
150723|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
150724|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
150725|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
150726|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of HypoThermosol solution)
150727|NCT01564407|O4|Outcome|No Injection|Empty safety control, no injection
150728|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
150729|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
150730|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
150731|NCT01564407|O4|Outcome|Single Admin Drug Day 28|Single administration of study drug on day 28
150732|NCT01564407|O3|Outcome|Single Admin Drug Day 0|Single administration of study drug on day 0
150733|NCT01564407|O2|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
150734|NCT01564407|O1|Outcome|no Injection|Safety cohort. 4 subjects received empty control. No injection
150735|NCT01564407|O4|Outcome|Single Admin Drug Day 28|Single administration on Day 28
150736|NCT01564407|O3|Outcome|Single Admin Drug Day 0|Single administration of study drug on day 0
150737|NCT01564407|O2|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
150738|NCT01564407|O1|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
150739|NCT01564407|O4|Outcome|Single Admin Drug Day 28|Single administration of study drug on day 28
150740|NCT01564407|O3|Outcome|Single Admin Drug Day 0|Single administration of study drug on day 0
150741|NCT01564407|O2|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
150742|NCT01564407|O1|Outcome|no Injection|Empty control no injection
150743|NCT01564407|E5|Reported Event|no Injection|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
150744|NCT01564407|E4|Reported Event|Admin Day 0 and 28|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
150745|NCT01564407|E3|Reported Event|Single Admin Day 28|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
150746|NCT01564407|E2|Reported Event|Single Admin Day 0|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
150747|NCT01564407|E1|Reported Event|Vehicle Only,|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
150748|NCT01564394|B3|Baseline|Total|Total of all reporting groups
150749|NCT01564394|B2|Baseline|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.
Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
150750|NCT01564394|B1|Baseline|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.
Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
150751|NCT01564394|P2|Participant Flow|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.
Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
151031|NCT01562743|P1|Participant Flow|SPM 962|"Rotigotine transdermal patch
A patch containing 2.25 - 6.75mg of rotigotine was administered once a day."
150802|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150851|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
150752|NCT01564394|P1|Participant Flow|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.
Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
150753|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.
Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
150754|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.
Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
150755|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.
Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
150756|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.
Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
150757|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.
Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
150758|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.
Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
150759|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.
Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
150760|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.
Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
150761|NCT01564394|E2|Reported Event|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.
Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
151032|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
151033|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
150762|NCT01564394|E1|Reported Event|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.
Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
150763|NCT01563978|B3|Baseline|Total|Total of all reporting groups
150764|NCT01563978|B2|Baseline|PLACEBO|Oral treatment
150765|NCT01563978|B1|Baseline|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150766|NCT01563978|P2|Participant Flow|PLACEBO|Oral treatment
150767|NCT01563978|P1|Participant Flow|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150768|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
150769|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150770|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
150771|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150772|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
150773|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150774|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
150775|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150776|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
150777|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150778|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
150779|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150780|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
150781|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150782|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
150783|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150784|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
150785|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150786|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
150787|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
150788|NCT01563978|E2|Reported Event|PLACEBO|
150789|NCT01563978|E1|Reported Event|FOSTA 100 MG BID|
150790|NCT01563536|B3|Baseline|Total|Total of all reporting groups
150791|NCT01563536|B2|Baseline|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150792|NCT01563536|B1|Baseline|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150793|NCT01563536|P2|Participant Flow|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150794|NCT01563536|P1|Participant Flow|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150795|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150796|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150797|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150798|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150799|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150800|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150801|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
151034|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
150803|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150804|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150805|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150806|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150807|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150808|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150809|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150810|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150811|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150812|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150813|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150814|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150815|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150816|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150817|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150818|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150819|NCT01563536|E2|Reported Event|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150820|NCT01563536|E1|Reported Event|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
150821|NCT01563198|B1|Baseline|Comfort Talk® Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests
Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
151035|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
150850|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
151172|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
150822|NCT01563198|P1|Participant Flow|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests
Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
150823|NCT01563198|O1|Outcome|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests
Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
150824|NCT01563198|O1|Outcome|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests
Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
150825|NCT01563198|O1|Outcome|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests
Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
150826|NCT01563198|E1|Reported Event|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests
Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
150827|NCT01563185|B1|Baseline|DUEXIS|"800 mg ibuprofen/26.6 mg famotidine
800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day"
150828|NCT01563185|P1|Participant Flow|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150829|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150830|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150831|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150832|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150833|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150834|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150835|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150836|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150837|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150838|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150839|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150840|NCT01563185|E1|Reported Event|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
150841|NCT01563172|B1|Baseline|Overall|This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.
150842|NCT01563172|P1|Participant Flow|Overall|This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.
150843|NCT01563172|O2|Outcome|Contol Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of control dentifrice.
150844|NCT01563172|O1|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
150845|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
150846|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
150847|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
150848|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
150849|NCT01563172|O2|Outcome|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
151036|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
150852|NCT01563172|O1|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
150853|NCT01563172|O2|Outcome|Contol Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of control dentifrice.
150854|NCT01563172|O1|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
150855|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
150856|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
150857|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
150858|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice
150859|NCT01563172|O2|Outcome|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
150860|NCT01563172|O1|Outcome|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
150861|NCT01563172|O2|Outcome|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
150862|NCT01563172|O1|Outcome|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
150863|NCT01563172|E5|Reported Event|Contol Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with control dentifrice.
150864|NCT01563172|E4|Reported Event|Experimental Dentifrice 1.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
150865|NCT01563172|E3|Reported Event|Experimental Dentifrice 1.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
150866|NCT01563172|E2|Reported Event|Experimental Dentifrice 0.5g, 2 Minutes Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
150867|NCT01563172|E1|Reported Event|Experimental Dentifrice 0.5g, 45 Seconds Brushing Group|Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
150868|NCT01563081|B3|Baseline|Total|Total of all reporting groups
150869|NCT01563081|B2|Baseline|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
150870|NCT01563081|B1|Baseline|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
150871|NCT01563081|P2|Participant Flow|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
150872|NCT01563081|P1|Participant Flow|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
150873|NCT01563081|O2|Outcome|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
150874|NCT01563081|O1|Outcome|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
150875|NCT01563081|O1|Outcome|Levocetrizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
150876|NCT01563081|O1|Outcome|Levocetrizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
150877|NCT01563081|O1|Outcome|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
150878|NCT01563081|O3|Outcome|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
151037|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
150879|NCT01563081|O2|Outcome|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
151041|NCT01562678|B2|Baseline|Placebo First, Then Liraglutide|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
150880|NCT01563081|O1|Outcome|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
150881|NCT01563081|E3|Reported Event|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
150882|NCT01563081|E2|Reported Event|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
150883|NCT01563081|E1|Reported Event|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
150884|NCT01563055|B1|Baseline|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150885|NCT01563055|P1|Participant Flow|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150886|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150887|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150888|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150951|NCT01563029|P2|Participant Flow|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150952|NCT01563029|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
151038|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
151042|NCT01562678|B1|Baseline|Liraglutide First, Then Placebo|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
151173|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
150889|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150890|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150891|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150892|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150893|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150894|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150895|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150953|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150896|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150897|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150898|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150899|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150900|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150901|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150902|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150954|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
151039|NCT01562743|E1|Reported Event|SPM 962|Rotigotine transdermal patch
150903|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150904|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150905|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150906|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150907|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150908|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150909|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150955|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
151040|NCT01562678|B3|Baseline|Total|Total of all reporting groups
150910|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150911|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150912|NCT01563055|O1|Outcome|Overall Study Arm|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150913|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150914|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150915|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150916|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150956|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150917|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150918|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150919|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150920|NCT01563055|O1|Outcome|Ofatumumab +Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150921|NCT01563055|O1|Outcome|Overall Study Arm|ar. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150922|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150923|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150957|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150924|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150925|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150926|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150927|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150928|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150929|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150930|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150958|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150931|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150932|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150933|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150934|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150935|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150936|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150937|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150959|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
152959|NCT01553708|P2|Participant Flow|Silver Zinc Sulfadiazine Cream|
150938|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150939|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150940|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
150941|NCT01563055|E1|Reported Event|Ofatumumab+Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28 day cycle in combination with chlorambucil 10 mg/meter squared (m^2) orally on Days 1-7 of every 28 day cycle for a minimum of 3 cycles, until best overall response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 8
150942|NCT01563029|B6|Baseline|Total|Total of all reporting groups
150943|NCT01563029|B5|Baseline|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150944|NCT01563029|B4|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150945|NCT01563029|B3|Baseline|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150946|NCT01563029|B2|Baseline|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150947|NCT01563029|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150948|NCT01563029|P5|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150949|NCT01563029|P4|Participant Flow|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150950|NCT01563029|P3|Participant Flow|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
151025|NCT01562756|B1|Baseline|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation
HVLA-SM: High velocity, low amplitude spinal manipulation"
152960|NCT01553708|P1|Participant Flow|Epidermal Growth Factor With Silver Sulfadiazine Cream|
150960|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150961|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150962|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150963|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150964|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150965|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150966|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150967|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150968|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150969|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150970|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150971|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150972|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150973|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150974|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150975|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150976|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150977|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150978|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
153062|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
150979|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150980|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150981|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150982|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150983|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150984|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150985|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150986|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150987|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150988|NCT01563029|O6|Outcome|Average of FF 50 µg OD and FF 100 µg OD|All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150989|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150990|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150991|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150992|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150993|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150994|NCT01563029|E5|Reported Event|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150995|NCT01563029|E4|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150996|NCT01563029|E3|Reported Event|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
151026|NCT01562756|P1|Participant Flow|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation
HVLA-SM: High velocity, low amplitude spinal manipulation"
151027|NCT01562756|O1|Outcome|Feasibility Outcomes|The feasibility outcomes (Primary outcomes 1 & 2) for this study include participant recruitment, enrollment, and the duration of the study.
150997|NCT01563029|E2|Reported Event|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150998|NCT01563029|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
150999|NCT01563003|B3|Baseline|Total|Total of all reporting groups
151000|NCT01563003|B2|Baseline|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
151001|NCT01563003|B1|Baseline|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases
Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
151002|NCT01563003|P2|Participant Flow|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
151003|NCT01563003|P1|Participant Flow|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases
Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
151004|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
151005|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases
Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
151006|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
151007|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases
Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
151008|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
151028|NCT01562756|O1|Outcome|Feasibility Outcomes|The feasibility outcomes (Primary outcomes 1 & 2) for this study include participant recruitment, enrollment, and the duration of the study.
151029|NCT01562756|E1|Reported Event|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation
HVLA-SM: High velocity, low amplitude spinal manipulation"
151030|NCT01562743|B1|Baseline|SPM 962|Rotigotine transdermal patch
151009|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases
Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
151010|NCT01563003|E2|Reported Event|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
151011|NCT01563003|E1|Reported Event|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases
Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
151012|NCT01562886|B1|Baseline|Rilpivirine and Truvada|TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
151013|NCT01562886|P1|Participant Flow|Rilpivirine and Truvada|TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
151014|NCT01562886|O1|Outcome|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Rilpivirine: Rilpivirine 25mg"
151015|NCT01562886|O1|Outcome|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Rilpivirine: Rilpivirine 25mg"
151016|NCT01562886|E1|Reported Event|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Rilpivirine: Rilpivirine 26mg"
151017|NCT01562873|B1|Baseline|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
151018|NCT01562873|P2|Participant Flow|Ruxolitinib-Cohort B|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
151019|NCT01562873|P1|Participant Flow|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
151020|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
151021|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
151022|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
151023|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
151024|NCT01562873|E1|Reported Event|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
151043|NCT01562678|P2|Participant Flow|Placebo First, Then Liraglutide|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
151044|NCT01562678|P1|Participant Flow|Liraglutide First, Then Placebo|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
151045|NCT01562678|O2|Outcome|Placebo|Placebo: In the placebo phase of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects will self-inject placebo once per day for 18 days. Participants had this first or second (liraglutide was the other phase).
151046|NCT01562678|O1|Outcome|Liraglutide|Liraglutide: In the experimental phase of this randomized, placebo-controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects started the treatment with a dose of 0.6 mg for the first week, then 1.2 mg for the second week and 1.8 mg for 3 days in the third week. This sequence may have occurred for their first phase or second phase (placebo was the other phase).
151047|NCT01562678|E2|Reported Event|Placebo|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide and 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
151048|NCT01562678|E1|Reported Event|Liraglutide|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo and 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
151049|NCT01562613|B1|Baseline|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
151050|NCT01562613|P1|Participant Flow|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
151051|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
151052|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
151053|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
151054|NCT01562613|E1|Reported Event|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
151055|NCT01562548|B5|Baseline|Total|Total of all reporting groups
151056|NCT01562548|B4|Baseline|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151057|NCT01562548|B3|Baseline|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151058|NCT01562548|B2|Baseline|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151059|NCT01562548|B1|Baseline|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151060|NCT01562548|P4|Participant Flow|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151061|NCT01562548|P3|Participant Flow|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151062|NCT01562548|P2|Participant Flow|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151063|NCT01562548|P1|Participant Flow|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151064|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151065|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151066|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151067|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151068|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151069|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151070|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151071|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151072|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151073|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151074|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151075|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151076|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151077|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151078|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151168|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151079|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151080|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151081|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151082|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151083|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151084|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151085|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151086|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151087|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151088|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151089|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151090|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151091|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151092|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151093|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151094|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151095|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151096|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151097|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151098|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151099|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151100|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151101|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151102|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151103|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151104|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID for 7 consecutive days
151105|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151106|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID for 7 consecutive days
151107|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151108|NCT01562548|E4|Reported Event|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151109|NCT01562548|E3|Reported Event|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
151110|NCT01562548|E2|Reported Event|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
151111|NCT01562548|E1|Reported Event|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
151112|NCT01562327|B1|Baseline|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
151113|NCT01562327|P1|Participant Flow|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
151114|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151115|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151116|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151117|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151118|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151119|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
154143|NCT01546636|B1|Baseline|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
151120|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151121|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151122|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151123|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151124|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151125|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151126|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151127|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151128|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
151129|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
151130|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
151131|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151132|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151133|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151134|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151135|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151136|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151137|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151138|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151139|NCT01562327|E1|Reported Event|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
151140|NCT01562314|B3|Baseline|Total|Total of all reporting groups
151141|NCT01562314|B2|Baseline|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151142|NCT01562314|B1|Baseline|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151143|NCT01562314|P2|Participant Flow|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151144|NCT01562314|P1|Participant Flow|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151145|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
151146|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
151147|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151148|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151149|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
151150|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
151151|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151152|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151153|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151154|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151155|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151156|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151157|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151158|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151159|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151160|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151161|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151162|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151163|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151164|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151165|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151166|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151167|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151170|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
151171|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
154346|NCT01545700|O5|Outcome|Placebo 0-4 Hours-4 Hours|
151174|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151175|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151176|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151177|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151178|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151179|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151180|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151181|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151182|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151183|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151184|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151185|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151186|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151187|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151188|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151189|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151190|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151191|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151192|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151193|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151194|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151195|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151196|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151197|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151198|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151199|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151200|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151201|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151202|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151203|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151204|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151205|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151206|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151207|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151208|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151209|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151210|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151211|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151212|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151213|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151214|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151215|NCT01562314|E2|Reported Event|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
151216|NCT01562314|E1|Reported Event|GWP42003|"(0-250mg, BD)
GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
151217|NCT01562275|B14|Baseline|Total|Total of all reporting groups
151218|NCT01562275|B13|Baseline|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151219|NCT01562275|B12|Baseline|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151220|NCT01562275|B11|Baseline|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151221|NCT01562275|B10|Baseline|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
154347|NCT01545700|O4|Outcome|Placebo 0-4 Hours-3 Hours|
151222|NCT01562275|B9|Baseline|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151223|NCT01562275|B8|Baseline|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151224|NCT01562275|B7|Baseline|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151225|NCT01562275|B6|Baseline|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151226|NCT01562275|B5|Baseline|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151227|NCT01562275|B4|Baseline|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151228|NCT01562275|B3|Baseline|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151229|NCT01562275|B2|Baseline|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151230|NCT01562275|B1|Baseline|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151231|NCT01562275|P13|Participant Flow|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151232|NCT01562275|P12|Participant Flow|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151233|NCT01562275|P11|Participant Flow|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151234|NCT01562275|P10|Participant Flow|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151235|NCT01562275|P9|Participant Flow|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151236|NCT01562275|P8|Participant Flow|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151237|NCT01562275|P7|Participant Flow|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151238|NCT01562275|P6|Participant Flow|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
188020|NCT01422213|E2|Reported Event|Vortioxetine 10 mg|
151239|NCT01562275|P5|Participant Flow|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151240|NCT01562275|P4|Participant Flow|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151241|NCT01562275|P3|Participant Flow|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151242|NCT01562275|P2|Participant Flow|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151243|NCT01562275|P1|Participant Flow|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 milligrams (mg) cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151244|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151245|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151246|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151247|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151248|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151249|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151250|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151251|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151252|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151253|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151254|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151255|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151256|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151390|NCT01561898|O1|Outcome|Entire Group|Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
188021|NCT01422213|E1|Reported Event|Placebo|
151275|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151257|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151258|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151259|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151260|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151261|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151262|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151263|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151264|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151265|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151266|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151267|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151268|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151269|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151270|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151271|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151272|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151273|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151274|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151276|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151277|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151278|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151279|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151280|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151281|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151282|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151283|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151284|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151285|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151286|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151287|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151288|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151289|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151290|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151291|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151292|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151525|NCT01561079|O4|Outcome|FHRV 36 Trough|Fetal heart rate variability at 36 weeks of gestation at time of trough maternal buprenorphine level
151293|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
158090|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
151294|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151295|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151296|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151297|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151298|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151299|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151300|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151301|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151302|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151303|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151304|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151305|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151306|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151307|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151308|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151309|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151310|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151526|NCT01561079|O3|Outcome|FHRV 32 Trough|Fetal heart rate variability at 32 weeks of gestation at time of trough maternal buprenorphine level
151311|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151312|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151313|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151314|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151315|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151316|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151317|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151318|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151319|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151320|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151321|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151322|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151323|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151324|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151325|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151326|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151327|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151328|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151567|NCT01560975|O2|Outcome|noPOAG/CPAP|Subjects with CPAP
151329|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151330|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151331|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151332|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151333|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151334|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151335|NCT01562275|O1|Outcome|DECs and Expansion Cohorts|Included all participants who were treated under Stage 1 (Dose Escalation Cohorts) and Stage 2 (Dose Expansion Cohorts).
151336|NCT01562275|O1|Outcome|Stage 1 DECs|During Stage 1, participants received cobimetinib and ipatasertib combination doses either under Arm A (21/7 dosing schedule [cobimetinib and ipatasertib taken concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days]) or under Arm B (intermittent cobimetinib dosing schedule [ipatasertib taken once daily on Days 1-21 consecutively with concurrent dosing of cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days)] until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151337|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151338|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151339|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151340|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151341|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151342|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151343|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151344|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151345|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151346|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151347|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151348|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151349|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151350|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151351|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151352|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151353|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151354|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151355|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151356|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151357|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151358|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151359|NCT01562275|E13|Reported Event|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151360|NCT01562275|E12|Reported Event|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151361|NCT01562275|E11|Reported Event|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151362|NCT01562275|E10|Reported Event|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151363|NCT01562275|E9|Reported Event|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151364|NCT01562275|E8|Reported Event|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151365|NCT01562275|E7|Reported Event|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151568|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
151366|NCT01562275|E6|Reported Event|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151367|NCT01562275|E5|Reported Event|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151368|NCT01562275|E4|Reported Event|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151369|NCT01562275|E3|Reported Event|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151370|NCT01562275|E2|Reported Event|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151371|NCT01562275|E1|Reported Event|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
151372|NCT01562132|B3|Baseline|Total|Total of all reporting groups
151373|NCT01562132|B2|Baseline|Fluconazole Alone|"Fluconazole monotherapy
Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
151374|NCT01562132|B1|Baseline|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine
Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
151375|NCT01562132|P2|Participant Flow|Fluconazole Alone|"Fluconazole monotherapy
Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
151376|NCT01562132|P1|Participant Flow|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine
Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
151377|NCT01562132|O2|Outcome|Fluconazole Alone|"Fluconazole monotherapy
Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
151378|NCT01562132|O1|Outcome|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine
Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
151379|NCT01562132|E2|Reported Event|Fluconazole Alone|"Fluconazole monotherapy
Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
151380|NCT01562132|E1|Reported Event|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine
Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
151381|NCT01561898|B5|Baseline|Total|Total of all reporting groups
151382|NCT01561898|B4|Baseline|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151383|NCT01561898|B3|Baseline|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151384|NCT01561898|B2|Baseline|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151385|NCT01561898|B1|Baseline|NO/PAL Group|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151386|NCT01561898|P4|Participant Flow|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151387|NCT01561898|P3|Participant Flow|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151388|NCT01561898|P2|Participant Flow|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151389|NCT01561898|P1|Participant Flow|NO/PAL Group|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151681|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
151391|NCT01561898|O4|Outcome|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
154348|NCT01545700|O3|Outcome|Placebo 0-4 Hours-2 Hours|Placebo 0-4 hours-2 hours
151392|NCT01561898|O3|Outcome|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151393|NCT01561898|O2|Outcome|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151394|NCT01561898|O1|Outcome|NO/PAL|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151395|NCT01561898|O4|Outcome|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151396|NCT01561898|O3|Outcome|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151397|NCT01561898|O2|Outcome|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151398|NCT01561898|O1|Outcome|NO/PAL|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151399|NCT01561898|E1|Reported Event|Entire Group|Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
151400|NCT01561716|B7|Baseline|Total|Total of all reporting groups
151401|NCT01561716|B6|Baseline|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
151402|NCT01561716|B5|Baseline|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
151403|NCT01561716|B4|Baseline|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
151404|NCT01561716|B3|Baseline|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
151405|NCT01561716|B2|Baseline|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
151406|NCT01561716|B1|Baseline|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
151407|NCT01561716|P6|Participant Flow|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
151408|NCT01561716|P5|Participant Flow|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
151409|NCT01561716|P4|Participant Flow|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
151410|NCT01561716|P3|Participant Flow|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
151411|NCT01561716|P2|Participant Flow|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
151412|NCT01561716|P1|Participant Flow|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
151413|NCT01561716|O6|Outcome|Treadmill Running/Walking|Energy expenditure during 30 min treadmill running/walking
151414|NCT01561716|O5|Outcome|Wii Fit Rhythm Boxing|Energy expenditure during 10 min Wii Fit Rhythm Boxing
151415|NCT01561716|O4|Outcome|Wii Fit Advanced Steps|Energy expenditure during 10 min Wii Fit Advanced Steps
151416|NCT01561716|O3|Outcome|Wii Fit Super Hula Hoop|Energy expenditure during 10 min Wii Fit Super Hula Hoop
151417|NCT01561716|O2|Outcome|Wii Fit Free Run|Energy expenditure during 30 min Wii Fit Free Run
151418|NCT01561716|O1|Outcome|At Rest|Energy expenditure at rest
151419|NCT01561716|E6|Reported Event|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
151420|NCT01561716|E5|Reported Event|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
151421|NCT01561716|E4|Reported Event|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
151422|NCT01561716|E3|Reported Event|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
151423|NCT01561716|E2|Reported Event|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
151424|NCT01561716|E1|Reported Event|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
151425|NCT01561703|B3|Baseline|Total|Total of all reporting groups
151426|NCT01561703|B2|Baseline|Control|"Patients will NOT receive postoperative antibiotic
No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
151427|NCT01561703|B1|Baseline|Intervention|"Patients will receive postoperative antibiotic after surgery.
Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .
Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
151428|NCT01561703|P2|Participant Flow|Control|"Patients will NOT receive postoperative antibiotic
No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
151450|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
188022|NCT01422187|B4|Baseline|Total|Total of all reporting groups
151527|NCT01561079|O2|Outcome|FHRV 28 Trough|Fetal heart rate variability at 28 weeks of gestation at time of trough maternal buprenorphine level
151528|NCT01561079|O1|Outcome|FHRV 24 Trough|Fetal heart rate variability at 24 weeks of gestation at time of trough maternal buprenorphine level
151429|NCT01561703|P1|Participant Flow|Intervention|"Patients will receive postoperative antibiotic after surgery.
Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .
Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
151430|NCT01561703|O2|Outcome|Control|"Patients will NOT receive postoperative antibiotic
No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
151431|NCT01561703|O1|Outcome|Intervention|"Patients will receive postoperative antibiotic after surgery.
Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .
Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
151432|NCT01561703|E2|Reported Event|Control|"Patients will NOT receive postoperative antibiotic
No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
151433|NCT01561703|E1|Reported Event|Intervention|"Patients will receive postoperative antibiotic after surgery.
Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .
Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
151434|NCT01561560|B1|Baseline|OVERALL|Delefilcon A contact lenses and narafilcon A contact lenses worn in randomized order. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
151435|NCT01561560|P2|Participant Flow|TRUEYE, Then DAILIES TOTAL1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
151436|NCT01561560|P1|Participant Flow|DAILIES TOTAL1, Then TRUEYE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
151437|NCT01561560|O2|Outcome|TRUEYE|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
151438|NCT01561560|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
151439|NCT01561560|E2|Reported Event|TRUEYE|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
151440|NCT01561560|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
151441|NCT01561469|B3|Baseline|Total|Total of all reporting groups
151442|NCT01561469|B2|Baseline|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151443|NCT01561469|B1|Baseline|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151444|NCT01561469|P2|Participant Flow|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151445|NCT01561469|P1|Participant Flow|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151446|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151447|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151448|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151449|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151482|NCT01561313|E1|Reported Event|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
151483|NCT01561300|B1|Baseline|Study Population|All participants who were randomised
151451|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151452|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151453|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151454|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151455|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151456|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151457|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151458|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151459|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151460|NCT01561469|E2|Reported Event|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151461|NCT01561469|E1|Reported Event|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
151462|NCT01561313|B3|Baseline|Total|Total of all reporting groups
151463|NCT01561313|B2|Baseline|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
151464|NCT01561313|B1|Baseline|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
151465|NCT01561313|P2|Participant Flow|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
151466|NCT01561313|P1|Participant Flow|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
151467|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
151468|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
151469|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
151470|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
151471|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
151472|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
151473|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
151474|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
151475|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
151476|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
151477|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
151478|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
151479|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
151480|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
151481|NCT01561313|E2|Reported Event|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
151484|NCT01561300|P2|Participant Flow|Tea, Then Wash Out, Then Control|Subjects first received Tea for one week with with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Control for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
151485|NCT01561300|P1|Participant Flow|Control, Then Washout, Then Tea|Subjects first received Control for one week with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Tea for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
151486|NCT01561300|O2|Outcome|Control Beverage|Participants when they received control
151487|NCT01561300|O1|Outcome|Tea Beverage|Participants when they received tea
151488|NCT01561300|O2|Outcome|Control Beverage|Participants when they received control
151489|NCT01561300|O1|Outcome|Tea Beverage|Participants when they received tea
151490|NCT01561300|O2|Outcome|Control Beverage|Participants when they received control
151491|NCT01561300|O1|Outcome|Tea Beverage|Participants when they received tea
151492|NCT01561300|E3|Reported Event|Placebo|Subjects when they consumed placebo for 6 days during the run in and during 7 days during the washout
151493|NCT01561300|E2|Reported Event|Control|Subjects when they consumed control for one week
151494|NCT01561300|E1|Reported Event|Tea Extract|Subjects when they consumed tea extract for one week
151495|NCT01561079|B1|Baseline|Fetal|Daily sublingual buprenorphine treatment of pregnant, opioid dependent women Subjects completing any maternal-fetal monitoring at any combination of the following gestational ages: 24, 28, 32 36 weeks
151496|NCT01561079|P1|Participant Flow|Maternal Buprenorphine Treatment|Daily sublingual buprenorphine treatment of pregnant, opioid dependent women Subjects undergo maternal-fetal monitoring at any combination of the following gestational time periods: 24, 28,32, 36 weeks of gestation
151497|NCT01561079|O8|Outcome|FM-FHR 36 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
151498|NCT01561079|O7|Outcome|FM-FHR 32 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
151499|NCT01561079|O6|Outcome|FM-FHR 28 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
151500|NCT01561079|O5|Outcome|FM-FHR 24 Peak|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
151501|NCT01561079|O4|Outcome|FM-FHR 36 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
151502|NCT01561079|O3|Outcome|FM-FHR 32 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
151503|NCT01561079|O2|Outcome|FM-FHR 28 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
151504|NCT01561079|O1|Outcome|FM-FHR 24 Trough|Fetal movement-fetal heart rate coupling during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
151505|NCT01561079|O8|Outcome|Fetal Movement 36 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
151506|NCT01561079|O7|Outcome|Fetal Movement 32 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
151507|NCT01561079|O6|Outcome|Fetal Movement 28 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
151508|NCT01561079|O5|Outcome|Fetal Movement 24 Peak|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of peak maternal buprenorphine level
151509|NCT01561079|O4|Outcome|Fetal Movement 36 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
151510|NCT01561079|O3|Outcome|Fetal Movement 32 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
151511|NCT01561079|O2|Outcome|Fetal Movement 28 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
151512|NCT01561079|O1|Outcome|Fetal Movement 24 Trough|Fetal movement during the 60 minute recordings at 24 weeks of gestation at time of trough maternal buprenorphine level
151513|NCT01561079|O8|Outcome|Accelerations36 Peak|Accelerations in fetal heart rate at 36 weeks of gestation at time of peak maternal buprenorphine level
151514|NCT01561079|O7|Outcome|Accelerations 32 Peak|Accelerations in fetal heart rate at 32 weeks of gestation at time of peak maternal buprenorphine level
151515|NCT01561079|O6|Outcome|Accelerations 28 Peak|Accelerations in fetal heart rate at 28 weeks of gestation at time of peak maternal buprenorphine level
151516|NCT01561079|O5|Outcome|Accelerations 24 Peak|Accelerations in fetal heart rate at 24 weeks of gestation at time of peak maternal buprenorphine level
151517|NCT01561079|O4|Outcome|Accelerations 36 Trough|Accelerations in fetal heart rate at 36 weeks of gestation at time of trough maternal buprenorphine level
151518|NCT01561079|O3|Outcome|Accelerations 32 Trough|Accelerations in fetal heart rate at 32 weeks of gestation at time of trough maternal buprenorphine level
151519|NCT01561079|O2|Outcome|Accelerations 28 Trough|Accelerations in fetal heart rate at 28 weeks of gestation at time of trough maternal buprenorphine level
151520|NCT01561079|O1|Outcome|Accelerations 24 Trough|Accelerations in fetal heart rate at 24 weeks of gestation at time of trough maternal buprenorphine level
151521|NCT01561079|O8|Outcome|FHRV 36 Peak|Fetal heart rate variability at 36 weeks gestation at the time of peak maternal buprenorphine levels
151522|NCT01561079|O7|Outcome|FHRV 32 Peak|Fetal heart rate variability at 32 weeks gestation at the time of peak maternal buprenorphine levels
151523|NCT01561079|O6|Outcome|FHRV 28 Peak|Fetal heart rate variability at 28 weeks gestation at the time of peak maternal buprenorphine levels
151524|NCT01561079|O5|Outcome|FHRV 24 Peak|Fetal heart rate variability at 24 weeks gestation at the time of peak maternal buprenorphine levels
151529|NCT01561079|O8|Outcome|FHR 36 Peak|Fetal heart rate in beats per minute at 36 weeks of gestation at time of peak maternal buprenorphine level
151530|NCT01561079|O7|Outcome|FHR 32 Peak|Fetal heart rate in beats per minute at 32 weeks of gestation at time of peak maternal buprenorphine level
151531|NCT01561079|O6|Outcome|FHR 28 Weeks Peak|Fetal heart rate in beats per minute at 28 weeks of gestation at time of peak maternal buprenorphine level
151532|NCT01561079|O5|Outcome|FHR 24 Weeks Peak|Fetal heart rate in beats per minute at 24 weeks of gestation at time of peak maternal buprenorphine level
151533|NCT01561079|O4|Outcome|FHR 36 Weeks Trough|Fetal heart rate in beats per minute at 36 weeks of gestation at time of trough maternal buprenorphine level
151534|NCT01561079|O3|Outcome|FHR 32 Weeks Trough|Fetal heart rate in beats per minute at 32 weeks of gestation at time of trough maternal buprenorphine level
151535|NCT01561079|O2|Outcome|FHR 28 Weeks Trough|Fetal heart rate in beats per minute at 28 weeks of gestation at time of trough maternal buprenorphine level
151536|NCT01561079|O1|Outcome|FHR 24 Weeks Trough|Fetal heart rate in beats per minute at 24 weeks of gestation at trough
151537|NCT01561079|E1|Reported Event|Maternal Buprenorphine Treatment|"Buprenorphine maintenance during pregnancy
Buprenorphine: Daily sublingual buprenorphine treatment of pregnant, opioid dependent women from up to 34 weeks gestation through one month of infant age.
Two severe adverse events were reported in the same infant patient. One infant had congenital heart disease and polydactyly"
151538|NCT01560988|B1|Baseline|All Study Participants|Participants were randomized to receive either borage and echium oils first, and corn oil second, or vice versa
151539|NCT01560988|P2|Participant Flow|First Corn Oil, Then Borage and Echium Seed Oil|Corn oil pills will be taken for six weeks, followed by a 6 week washout. Then subjects received borage and echium oil tablets for six week.
151540|NCT01560988|P1|Participant Flow|First Borage and Echium, Then Corn Oil|Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks, followed by a 6 week washout. Then, subjects were crossed over to receive corn oil (10 g) daily for six weeks
151541|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.
Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
151542|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.
Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks"
151543|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.
Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
151544|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.
Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
151545|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.
Corn oil pills: Corn oils pills will be taken three times per day for six weeks"
151546|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.
Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil."
151547|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.
Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
151548|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.
Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil."
151549|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.
Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
151550|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.
Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks"
151551|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.
Corn oil pills will be taken three times per day for six weeks."
151552|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.
Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
151553|NCT01560988|O2|Outcome|Corn Oil Pills|"Corn oil pills will be taken for six weeks.
Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
151554|NCT01560988|O1|Outcome|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.
Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
151555|NCT01560988|E2|Reported Event|Corn Oil Pills|"Corn oil pills will be taken for six weeks.
Corn oil pills: Corn oils pills will be taken three times per day for six weeks."
151556|NCT01560988|E1|Reported Event|Borage and Echium Seed Oils|"Borage and echium seed oils will be taken for six weeks.
Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks."
151557|NCT01560975|B1|Baseline|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
151558|NCT01560975|P1|Participant Flow|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
151559|NCT01560975|O4|Outcome|noPOAG/ no CPAP|No POAG patients without CPAP therapy
151560|NCT01560975|O3|Outcome|POAG/no CPAP|POAG patients without CPAP therapy
151561|NCT01560975|O2|Outcome|noPOAG/CPAP|no POAG patients with CPAP therapy
151562|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
151563|NCT01560975|O4|Outcome|noPOAG/ no CPAP|No POAG patients without CPAP therapy
151564|NCT01560975|O3|Outcome|POAG/no CPAP|POAG patients without CPAP therapy
151565|NCT01560975|O2|Outcome|noPOAG/CPAP|no POAG patients with CPAP therapy
151566|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
151569|NCT01560975|E1|Reported Event|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
151570|NCT01560819|B3|Baseline|Total|Total of all reporting groups
151571|NCT01560819|B2|Baseline|Donors|Healthy donors (>18 years of age) were chosen by participants. Donors were required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
151572|NCT01560819|B1|Baseline|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
151573|NCT01560819|P2|Participant Flow|Donors|Healthy donors (>18 years of age) were chosen by the participants. Donors were required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
151574|NCT01560819|P1|Participant Flow|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
151575|NCT01560819|O1|Outcome|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate ulcerative colitis (UC) (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
151576|NCT01560819|E1|Reported Event|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
151577|NCT01560507|B4|Baseline|Total|Total of all reporting groups
151578|NCT01560507|B3|Baseline|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
151579|NCT01560507|B2|Baseline|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
151580|NCT01560507|B1|Baseline|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
151581|NCT01560507|P3|Participant Flow|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
151582|NCT01560507|P2|Participant Flow|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
151583|NCT01560507|P1|Participant Flow|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
151584|NCT01560507|O3|Outcome|Bupropion (Zyban) and Nicotine Patches|"This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
bupropion (Zyban) & nicotine patches: After being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive 150mg of bupropion once daily and 21mg nicotine patch for first 3 days; 150mg of bupropion twice daily and 21mg nicotine patch for 7 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
151585|NCT01560507|O2|Outcome|Nicotine Patches|"This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
nicotine patches: 21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks."
151586|NCT01560507|O1|Outcome|Varenicline (Chantix)|"This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
varenicline (Chantix): For the first 3 days after being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
151587|NCT01560507|O3|Outcome|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
151588|NCT01560507|O2|Outcome|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
151589|NCT01560507|O1|Outcome|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
151590|NCT01560507|E3|Reported Event|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
151591|NCT01560507|E2|Reported Event|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
151592|NCT01560507|E1|Reported Event|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
151593|NCT01560429|B3|Baseline|Total|Total of all reporting groups
151594|NCT01560429|B2|Baseline|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
151595|NCT01560429|B1|Baseline|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in the post-anesthesia care unit (PACU). Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
151596|NCT01560429|P2|Participant Flow|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Postoperatively all patients received continuous epidural analgesia at infusion rates to reach pain scores of ≤ 3 while in PACU. Those randomized to the Continuous epidural analgesia group remained on the same CEA regimen.
151597|NCT01560429|P1|Participant Flow|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Continuous epidural infusion rates were set to achieve scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Upon allocation to the preoperatively determined randomization, the PCEA were switched the receive 2/3 of their baseline infusion as continuous background infusion but they also had the option to self administered the remaining 1/3rd of the dose via patient controlled epidural analgesia (PCEA)
151598|NCT01560429|O2|Outcome|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
151599|NCT01560429|O1|Outcome|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
151600|NCT01560429|O2|Outcome|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. CEA infusion rates were set to achieve pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Those allocated to the CEA group remained on the same continuous epidural infusion rate to which they were optimized.
151601|NCT01560429|O1|Outcome|Patient-controlled Epidural Analgesia|An epidural catheter sited preoperatively so analgesics can be administered postoperatively. Patients were titrated on a continuous analgesic epidural infusion until stable pain scores of ≤ 3 were reached while in PACU. Once stable, they were allocated to their preoperatively determined randomization which meant they still received 2/3rd of the anesthetic as a background infusion but also had the option to self-administer the remaining 1/3rd dose as patient controlled epidural analgesia (PCEA). Rescue analgesia was available upon request.
151602|NCT01560429|E2|Reported Event|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
151603|NCT01560429|E1|Reported Event|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
151604|NCT01560403|B3|Baseline|Total|Total of all reporting groups
151605|NCT01560403|B2|Baseline|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
151606|NCT01560403|B1|Baseline|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644)
151607|NCT01560403|P2|Participant Flow|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
151608|NCT01560403|P1|Participant Flow|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
151609|NCT01560403|O2|Outcome|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644).
151610|NCT01560403|O1|Outcome|NT,PBO/TED|This group represents those subjects who either participated in Study CL0600-020 (NCT00798967) and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension study CL0600-021 (NCT00930644) directly.
151611|NCT01560403|E2|Reported Event|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
151682|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
151683|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
151684|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
151612|NCT01560403|E1|Reported Event|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
151613|NCT01560260|B1|Baseline|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies"
151614|NCT01560260|P1|Participant Flow|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies"
151615|NCT01560260|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies"
151616|NCT01560260|E1|Reported Event|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies"
151617|NCT01560234|B9|Baseline|Total|Total of all reporting groups
151618|NCT01560234|B8|Baseline|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
151619|NCT01560234|B7|Baseline|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
151620|NCT01560234|B6|Baseline|Cohort 5|AZD8848 15 μg
151621|NCT01560234|B5|Baseline|Cohort 4|AZD8848 5 μg
151622|NCT01560234|B4|Baseline|Cohort 3|AZD8848 1.5 μg
151623|NCT01560234|B3|Baseline|Cohort 2|AZD8848 0.5 ug
151624|NCT01560234|B2|Baseline|Cohort 1|AZD8848 0.15 μg
151625|NCT01560234|B1|Baseline|Placebo|Commercial 0.9% sodium chloride solution.
151626|NCT01560234|P8|Participant Flow|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
151627|NCT01560234|P7|Participant Flow|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
151628|NCT01560234|P6|Participant Flow|Cohort 5|AZD8848 15 μg
151629|NCT01560234|P5|Participant Flow|Cohort 4|AZD8848 5 μg
151630|NCT01560234|P4|Participant Flow|Cohort 3|AZD8848 1.5 μg
151631|NCT01560234|P3|Participant Flow|Cohort 2|AZD8848 0.5 ug
151632|NCT01560234|P2|Participant Flow|Cohort 1|AZD8848 0.15 μg
151633|NCT01560234|P1|Participant Flow|Placebo|Commercial 0.9% sodium chloride solution.
151634|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
151635|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
151636|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
151637|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
151638|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
151639|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
151640|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
151641|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
151642|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
151643|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
151644|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
151645|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
151646|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
151647|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
151648|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
151649|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
151650|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
151651|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
151652|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
151653|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
151654|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
151655|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
151656|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
151657|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
151658|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
151659|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
151660|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
151661|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
151662|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
151663|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
151664|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
151665|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
151666|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
151667|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
151668|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
151669|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
151670|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
151671|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
151672|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
151673|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
151674|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
151675|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
151676|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
151677|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
151678|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
151679|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
151680|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
151690|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
151691|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
151692|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
151693|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
151694|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
151695|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
151696|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
151697|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
151698|NCT01560234|E8|Reported Event|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
151699|NCT01560234|E7|Reported Event|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
151700|NCT01560234|E6|Reported Event|Cohort 5|AZD8848 15 μg
151701|NCT01560234|E5|Reported Event|Cohort 4|AZD8848 5 μg
151702|NCT01560234|E4|Reported Event|Cohort 3|AZD8848 1.5 μg
151703|NCT01560234|E3|Reported Event|Cohort 2|AZD8848 0.5 ug
151704|NCT01560234|E2|Reported Event|Cohort 1|AZD8848 0.15 μg
151705|NCT01560234|E1|Reported Event|Placebo|Commercial 0.9% sodium chloride solution.
151706|NCT01560143|B1|Baseline|Tigecycline|"All subjects receive a single dose of tigecycline
Tigecycline: 100 mg IV as a single infusion over 30 minutes"
151707|NCT01560143|P1|Participant Flow|Tigecycline|"All subjects receive a single dose of tigecycline
Tigecycline: 100 mg IV as a single infusion over 30 minutes"
151708|NCT01560143|O1|Outcome|Serum AUC of Tigecycline|"All subjects receive a single dose of tigecycline
Tigecycline: 100 mg IV as a single infusion over 30 minutes"
151709|NCT01560143|E1|Reported Event|Tigecycline|"All subjects receive a single dose of tigecycline
Tigecycline: 100 mg IV as a single infusion over 30 minutes"
151710|NCT01559935|B1|Baseline|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
151711|NCT01559935|P1|Participant Flow|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
151712|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
151713|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
151714|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
188175|NCT01421498|B3|Baseline|Total|Total of all reporting groups
151750|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
151751|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
151752|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
154349|NCT01545700|O2|Outcome|Placebo 0-4 Hours-1 Hour|Placebo 0-4 hours-1 hour
151715|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
151716|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
151717|NCT01559935|E1|Reported Event|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
151718|NCT01559922|B3|Baseline|Total|Total of all reporting groups
151719|NCT01559922|B2|Baseline|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
151720|NCT01559922|B1|Baseline|Placebo|"Normal Saline
Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
151721|NCT01559922|P2|Participant Flow|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
151722|NCT01559922|P1|Participant Flow|Placebo|Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart
151723|NCT01559922|O2|Outcome|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
151724|NCT01559922|O1|Outcome|Placebo|"Normal Saline
Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
151725|NCT01559922|E2|Reported Event|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
151726|NCT01559922|E1|Reported Event|Placebo|"Normal Saline
Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
151727|NCT01559857|B3|Baseline|Total|Total of all reporting groups
151728|NCT01559857|B2|Baseline|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.
Sugar Pill: Placebo"
151729|NCT01559857|B1|Baseline|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.
Pioglitazone: 30mg once daily for 12 weeks"
151730|NCT01559857|P2|Participant Flow|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.
Sugar Pill: Placebo"
151731|NCT01559857|P1|Participant Flow|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.
Pioglitazone: 30mg once daily for 12 weeks"
151732|NCT01559857|O4|Outcome|Placebo - IR|Participants who received the sugar pill and were insulin resistant.
151733|NCT01559857|O3|Outcome|Pio - IR|Participants who received pioglitazone and were insulin resistant.
151734|NCT01559857|O2|Outcome|Placebo - IS|Participants who received placebo and were insulin sensitive.
151735|NCT01559857|O1|Outcome|Pio - IS|Participants who received pioglitazone and were insulin sensitive.
151736|NCT01559857|O4|Outcome|Placebo - IR|Participants who received the sugar pill and were insulin resistant.
151737|NCT01559857|O3|Outcome|Pio - IR|Participants who received pioglitazone and were insulin resistant.
151738|NCT01559857|O2|Outcome|Placebo - IS|Participants who received placebo and were insulin sensitive.
151739|NCT01559857|O1|Outcome|Pio - IS|Participants who received pioglitazone and were insulin sensitive.
151740|NCT01559857|O4|Outcome|Placebo - IR|Participants who received the sugar pill and were insulin resistant.
151741|NCT01559857|O3|Outcome|Pio - IR|Participants who received pioglitazone and were insulin resistant.
151742|NCT01559857|O2|Outcome|Placebo - IS|Participants who received placebo and were insulin sensitive.
151743|NCT01559857|O1|Outcome|Pio - IS|Participants who received pioglitazone and were insulin sensitive.
151744|NCT01559857|E2|Reported Event|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.
Sugar Pill: Placebo"
151745|NCT01559857|E1|Reported Event|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.
Pioglitazone: 30mg once daily for 12 weeks"
151746|NCT01559844|B1|Baseline|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
151747|NCT01559844|P1|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
151748|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
151749|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
151753|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
151754|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
151755|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
151756|NCT01559844|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
151757|NCT01559675|B3|Baseline|Total|Total of all reporting groups
151758|NCT01559675|B2|Baseline|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed
Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
151759|NCT01559675|B1|Baseline|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed
Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
151760|NCT01559675|P2|Participant Flow|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed
Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
151761|NCT01559675|P1|Participant Flow|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed
Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
151762|NCT01559675|O2|Outcome|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed
Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
151763|NCT01559675|O1|Outcome|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed
Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
151764|NCT01559675|E2|Reported Event|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed
Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
151806|NCT01559454|E2|Reported Event|Buprenorphine/Naloxone|Buprenorphine 4-16 mg/day divided 2-4 times a day for 6 months
151807|NCT01559454|E1|Reported Event|Methadone|Methadone 10-60 mg/day divided 2-4 times a day for 6 months
151808|NCT01559311|B4|Baseline|Total|Total of all reporting groups
151809|NCT01559311|B3|Baseline|DDDR|Control Group – DDDR Standard Therapy
151813|NCT01559311|P2|Participant Flow|CRT-P ON|Echo-guided Group – Cardiac resynchronization therapy pacemaker (CRT-P) Standard Therapy
151814|NCT01559311|P1|Participant Flow|CRT-P OFF|Echo-guided Group – Dual chamber pacemaker (DDDR) Standard Therapy
151815|NCT01559311|O3|Outcome|DDDR|Control Group – DDDR Standard Therapy
151816|NCT01559311|O2|Outcome|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
151817|NCT01559311|O1|Outcome|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
151765|NCT01559675|E1|Reported Event|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed
Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
151766|NCT01559649|B3|Baseline|Total|Total of all reporting groups
151767|NCT01559649|B2|Baseline|Nurses|Registered nurses working on MEDVAMC stroke wards
151768|NCT01559649|B1|Baseline|Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke.
151769|NCT01559649|P2|Participant Flow|Registered Nurses|Stroke ward nurses. The nurses administered and interpret the swallowing screening items. Speech pathologists made blinded, simultaneous interpretations of the screening items. Nurse and speech pathologist interpretation were used to establish nursing reliability.
151770|NCT01559649|P1|Participant Flow|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke recruited. Individuals with a history of neurological disease other than stroke, head and neck structural surgery, or history of dysphagia unrelated to the current stroke were excluded . Individuals who were obtunded, medically unstable, greater than 5 days post-admission were excluded. Patients with language or cognitive deficits who were judged by the attending neurologist to not have capacity to provide informed consent were eligible to participate, but they had to have an authorized representative available within 24 hours of admission to provide consent. Patients underwent swallowing screening and videofluoroscopic swallowing study (VFSS) to establish validity of screening items
151771|NCT01559649|O1|Outcome|Nurses|Only nurses administered and interpreted the screening items.
151772|NCT01559649|O1|Outcome|Nurses|Only nurses administered and interpreted the screening items.
151773|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses
151774|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
151775|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses.
151776|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
151777|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses.
151778|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
151779|NCT01559649|E1|Reported Event|Patients With Suspected Stroke|Individuals admitted with suspected ischemic or hemorrhagic stroke
151780|NCT01559506|B3|Baseline|Total|Total of all reporting groups
151781|NCT01559506|B2|Baseline|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.
Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
151782|NCT01559506|B1|Baseline|No Device|Subject does not receive ABS system
151783|NCT01559506|P2|Participant Flow|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.
Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
151784|NCT01559506|P1|Participant Flow|No Device|Subject does not receive ABS system
151785|NCT01559506|O2|Outcome|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.
Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
151786|NCT01559506|O1|Outcome|No Device|Subject does not receive ABS system
151787|NCT01559506|E2|Reported Event|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.
Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
151788|NCT01559506|E1|Reported Event|No Device|Subject does not receive ABS system
151789|NCT01559454|B3|Baseline|Total|Total of all reporting groups
151790|NCT01559454|B2|Baseline|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
151791|NCT01559454|B1|Baseline|Methadone|"10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
151792|NCT01559454|P2|Participant Flow|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
151793|NCT01559454|P1|Participant Flow|Methadone|"10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
151794|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
151795|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
151796|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
151797|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
151798|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
151799|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
151800|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
151801|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
151802|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
151803|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
151804|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
151805|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
188176|NCT01421498|B2|Baseline|Placebo|
151824|NCT01559116|B1|Baseline|All Subjects|Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 μg, 5/5 μg), tiotropium (2.5 μg, 5 μg) and olodaterol (5 μg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM].
151825|NCT01559116|P1|Participant Flow|All Subjects|Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 μg, 5/5 μg), tiotropium (2.5 μg, 5 μg) and olodaterol (5 μg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM].
151826|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151827|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151828|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151829|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151830|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151831|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
151832|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151833|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151834|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151835|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151836|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151837|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
151838|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151839|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151840|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151841|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151842|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151843|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
151844|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151845|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151846|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151847|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151848|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151849|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
151850|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151851|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151997|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
151852|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151853|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151854|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151855|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
151856|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151857|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151858|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151859|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151860|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151861|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
151862|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151863|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151864|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151865|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151866|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151867|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.)
151868|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151869|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151870|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151871|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151872|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151873|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
151874|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151875|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151876|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151877|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151878|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151879|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
151880|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151881|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151882|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151883|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151884|NCT01559116|O2|Outcome|Olodaterol (5 µg)|"Olodaterol solution for inhalation - RESPIMAT
2 oral inhalations once daily in the morning for 6 weeks."
151885|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT:2 Oral inhalations once daily in the morning for 6 weeks.
151886|NCT01559116|E6|Reported Event|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151887|NCT01559116|E5|Reported Event|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151888|NCT01559116|E4|Reported Event|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151889|NCT01559116|E3|Reported Event|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
151890|NCT01559116|E2|Reported Event|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
151891|NCT01559116|E1|Reported Event|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
151892|NCT01559064|B4|Baseline|Total|Total of all reporting groups
151893|NCT01559064|B3|Baseline|Age Group C|"Subjects over 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151894|NCT01559064|B2|Baseline|Age Group B|"Subjects 40 to 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151930|NCT01559012|E1|Reported Event|Clonidine|patients are treated with transdermal clonidine patch 5 mg for 5 days
151931|NCT01558791|B3|Baseline|Total|Total of all reporting groups
151895|NCT01559064|B1|Baseline|Age Group A|"Subjects 30 to 40 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151896|NCT01559064|P3|Participant Flow|Age Group C|"Subjects over 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151897|NCT01559064|P2|Participant Flow|Age Group B|"Subjects 40 to 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151898|NCT01559064|P1|Participant Flow|Age Group A|"Subjects 30 to 40 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151899|NCT01559064|O3|Outcome|Age Group C|"Subjects over 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151900|NCT01559064|O2|Outcome|Age Group B|"Subjects 40 to 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151901|NCT01559064|O1|Outcome|Age Group A|"Subjects 30 to 40 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151902|NCT01559064|E3|Reported Event|Age Group C|"Subjects over 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151903|NCT01559064|E2|Reported Event|Age Group B|"Subjects 40 to 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151904|NCT01559064|E1|Reported Event|Age Group A|"Subjects 30 to 40 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
151905|NCT01559012|B3|Baseline|Total|Total of all reporting groups
151906|NCT01559012|B2|Baseline|Placebo First - Clonidine Second|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days
Clonidine : transdermal clonidine patch 5 mg q. 5 days"
151907|NCT01559012|B1|Baseline|Clonidine First - Placebo Second|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days
Clonidine : transdermal clonidine patch 5 mg q. 5 days"
151908|NCT01559012|P2|Participant Flow|Placebo First - Clonidine Second|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days
Clonidine : transdermal clonidine patch 5 mg q. 5 days"
151909|NCT01559012|P1|Participant Flow|Clonidine First - Placebo Second|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days
Clonidine : transdermal clonidine patch 5 mg q. 5 days"
151910|NCT01559012|O2|Outcome|Placebo|diastolic blood pressure was recorded every day during placebo cycle
151911|NCT01559012|O1|Outcome|Clonidine|diastolic blood pressure was recorded every day during clonidine treatment cycle
151912|NCT01559012|O2|Outcome|Placebo|systolic blood pressure was recorded during placebo cycle
151913|NCT01559012|O1|Outcome|Clonidine|systolic blood pressure was recorded during clonidine treatment cycle
151914|NCT01559012|O2|Outcome|APGAR Score at 5'|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
151915|NCT01559012|O1|Outcome|APGAR Score at 1'|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
151916|NCT01559012|O1|Outcome|Mean Birth Weight of 12 Patients|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
Allocation order randomized"
151917|NCT01559012|O2|Outcome|Placebo|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
151918|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
151919|NCT01559012|O2|Outcome|Placebo|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
151920|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round.
151921|NCT01559012|O2|Outcome|Placebo|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
Clonidine : transdermal clonidine patch 5 mg q. 5 days"
151922|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
151923|NCT01559012|O2|Outcome|Placebo|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
Allocation order randomized"
151924|NCT01559012|O1|Outcome|Clonidine|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
Allocation order randomized"
151925|NCT01559012|O2|Outcome|Placebo|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days
Clonidine : transdermal clonidine patch 5 mg q. 5 days"
151926|NCT01559012|O1|Outcome|Clonidine|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days
Clonidine : transdermal clonidine patch 5 mg q. 5 days"
151927|NCT01559012|O2|Outcome|Placebo|"Six patients are treated with TD clonidine first,for 5 days, then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.
The allocation order for every patient is randomized
Every patient is the comparison as to herself"
151928|NCT01559012|O1|Outcome|Clonidine|"Six patients are treated with TD clonidine first for 5 days then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.
The allocation order for every patient is randomized.
Every patient is the comparison as to herself"
151929|NCT01559012|E2|Reported Event|Placebo|patients are treated with placebo (sham patch) for 5 days
151932|NCT01558791|B2|Baseline|TBI Handout|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.
TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
151933|NCT01558791|B1|Baseline|Screened as Usual|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
151934|NCT01558791|P2|Participant Flow|TBI Handout|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.
TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
151935|NCT01558791|P1|Participant Flow|Screened as Usual|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
151936|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.
TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
151937|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
151938|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.
TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
151939|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
151940|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.
TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
151941|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
151942|NCT01558791|E2|Reported Event|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.
TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
151943|NCT01558791|E1|Reported Event|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
151944|NCT01558739|B1|Baseline|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151945|NCT01558739|P1|Participant Flow|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151946|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151947|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151948|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151949|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151950|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151951|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151952|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151953|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151954|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151998|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
151955|NCT01558739|E1|Reported Event|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
151956|NCT01558700|B3|Baseline|Total|Total of all reporting groups
151957|NCT01558700|B2|Baseline|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.
Sugar pill: Matching capsule given once a day for a total of 17 weeks."
151958|NCT01558700|B1|Baseline|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
151959|NCT01558700|P2|Participant Flow|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.
Sugar pill: Matching capsule given once a day for a total of 17 weeks."
151960|NCT01558700|P1|Participant Flow|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
151961|NCT01558700|O2|Outcome|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.
Sugar pill: Matching capsule given once a day for a total of 17 weeks."
151962|NCT01558700|O1|Outcome|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
151963|NCT01558700|O2|Outcome|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.
Sugar pill: Matching capsule given once a day for a total of 17 weeks."
151964|NCT01558700|O1|Outcome|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
151965|NCT01558700|E2|Reported Event|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.
Sugar pill: Matching capsule given once a day for a total of 17 weeks."
151966|NCT01558700|E1|Reported Event|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
151967|NCT01558674|B3|Baseline|Total|Total of all reporting groups
151968|NCT01558674|B2|Baseline|Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg|Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out.
151969|NCT01558674|B1|Baseline|MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg|Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out.
151970|NCT01558674|P2|Participant Flow|Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg|Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out.
151971|NCT01558674|P1|Participant Flow|MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg|Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out.
151972|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
151973|NCT01558674|O2|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
151974|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
151975|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
151976|NCT01558674|O2|Outcome|MK-7145 16 mg|14 mg of MK-7145 once daily for 14 days
151977|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
151978|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
151979|NCT01558674|O2|Outcome|MK-7145 16 mg|14 mg of MK-7145 once daily for 14 days
151980|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
151981|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
151982|NCT01558674|O2|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
151983|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
151984|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
151985|NCT01558674|O2|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
151986|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
151987|NCT01558674|O4|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
151988|NCT01558674|O3|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
151989|NCT01558674|O2|Outcome|MK-7145 10 mg (Part 2:Period 2)|10 mg of MK-7145 once daily for 14 days
151990|NCT01558674|O1|Outcome|Furosemide/Torsemide (Part 2; Period 1)|Stable, clinically optimized maintenance dose regimen of furosemide or torsemide for at least 2 weeks.
151991|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
151992|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
151993|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
151994|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
151995|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
151996|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
152050|NCT01558297|B4|Baseline|Total|Total of all reporting groups
151999|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
152000|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
152001|NCT01558674|O3|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
152002|NCT01558674|O2|Outcome|Furosemide 40 mg BID (Part 1: Period 2)|40 mg Furosemide tablet BID for 5 days administered in a fasted state
152003|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
152004|NCT01558674|O4|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
152005|NCT01558674|O3|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
152006|NCT01558674|O2|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
152007|NCT01558674|O1|Outcome|Furosemide/Torsemide (Part 2; Period 1)|Stable, clinically optimized maintenance dose regimen of furosemide or torsemide for at least 2 weeks.
152008|NCT01558674|O3|Outcome|MK-7145 16 mg (Part 1: Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
152009|NCT01558674|O2|Outcome|Furosemide 40 mg BID (Part 1: Period 2)|40 mg Furosemide tablet BID for 5 days administered in a fasted state
152010|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
152011|NCT01558674|E3|Reported Event|Post Trial|Participants who received at least one dose of study drug during Period 1 or 2 of Part 1 of the study
152012|NCT01558674|E2|Reported Event|Furosemide 40 mg (Part 1:Period 2)|Two daily doses of one 40 mg Furosemide tablet for 5 days administered in a fasted state
152013|NCT01558674|E1|Reported Event|MK-7145 8 mg (Part 1:Period 1)|Single daily dose of 8 mg MK-7145 for 5 days, capsules, orally administered in a fasted state
152014|NCT01555567|B5|Baseline|Total|Total of all reporting groups
152015|NCT01555567|B4|Baseline|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
152016|NCT01555567|B3|Baseline|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
152017|NCT01555567|B2|Baseline|Standard of Care|This group will undergo standard ACL rehabilitation
152018|NCT01555567|B1|Baseline|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
152019|NCT01555567|P4|Participant Flow|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
152020|NCT01555567|P3|Participant Flow|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
152021|NCT01555567|P2|Participant Flow|Standard of Care|This group will undergo standard ACL rehabilitation
152022|NCT01555567|P1|Participant Flow|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo neuromuscular electrical stimulation (NMES) following anterior cruciate ligament (ACLr). Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
152023|NCT01555567|O4|Outcome|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
152024|NCT01555567|O3|Outcome|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
152025|NCT01555567|O2|Outcome|Standard of Care|This group will undergo standard ACL rehabilitation
152026|NCT01555567|O1|Outcome|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
152143|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
152027|NCT01555567|O4|Outcome|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
152028|NCT01555567|O3|Outcome|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
152029|NCT01555567|O2|Outcome|Standard of Care|This group will undergo standard ACL rehabilitation
152174|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|
152030|NCT01555567|O1|Outcome|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
152031|NCT01555567|E4|Reported Event|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
152032|NCT01555567|E3|Reported Event|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
152033|NCT01555567|E2|Reported Event|Standard of Care|This group will undergo standard ACL rehabilitation
152034|NCT01555567|E1|Reported Event|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
152035|NCT01558596|B3|Baseline|Total|Total of all reporting groups
152036|NCT01558596|B2|Baseline|RIPC|"Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.
Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion."
152037|NCT01558596|B1|Baseline|Sham|"Blood pressure cuff inflated to 40-50 mmHg in the upper extremity
Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity"
152038|NCT01558596|P2|Participant Flow|RIPC|"Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.
Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion."
152039|NCT01558596|P1|Participant Flow|Sham|"Blood pressure cuff inflated to 40-50 mmHg in the upper extremity
Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity"
152040|NCT01558596|O2|Outcome|RIPC|Blood pressure cuff inflated to 200 mmHg over the brachial artery while confirming absence of radial and ulnar pulse. Total duration of protocol was 30 minutes, equally divided between reperfusion and ischemia.
152041|NCT01558596|O1|Outcome|Sham|Blood pressure cuff inflated to 40-50 mmHg over brachial artery
152042|NCT01558596|E2|Reported Event|RIPC|Blood pressure cuff inflated above systolic blood pressure (200 mmHg) over brachial artery to induce forearm ischemia. Total duration of protocol 30 minutes equally divided between ischemia ( 5 minutes x 3) and reperfusion ( 5 minutes x3)
152043|NCT01558596|E1|Reported Event|Sham|Blood pressure cuff inflated to 40 mmHg to mask controls
152044|NCT01558492|B1|Baseline|All Subjects|"Carboplatin and Paclitaxel
Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
152045|NCT01558492|P1|Participant Flow|All Subjects|"Carboplatin and Paclitaxel
Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
152046|NCT01558492|O1|Outcome|All Subjects|"Carboplatin and Paclitaxel
Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
152047|NCT01558492|O1|Outcome|All Subjects|"Carboplatin and Paclitaxel
Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
152048|NCT01558492|O1|Outcome|All Subjects|"Carboplatin and Paclitaxel
Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
152049|NCT01558492|E1|Reported Event|All Subjects|"Carboplatin and Paclitaxel
Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
152051|NCT01558297|B3|Baseline|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
152052|NCT01558297|B2|Baseline|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
152053|NCT01558297|B1|Baseline|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
152054|NCT01558297|P3|Participant Flow|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
152055|NCT01558297|P2|Participant Flow|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
152056|NCT01558297|P1|Participant Flow|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
152175|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|
152057|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
152058|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
152059|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
152060|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
152061|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
152062|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
152063|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
152064|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
152065|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
152066|NCT01558297|E3|Reported Event|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
152067|NCT01558297|E2|Reported Event|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
152068|NCT01558297|E1|Reported Event|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
152069|NCT01558271|B4|Baseline|Total|Total of all reporting groups
152070|NCT01558271|B3|Baseline|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152071|NCT01558271|B2|Baseline|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152072|NCT01558271|B1|Baseline|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152073|NCT01558271|P3|Participant Flow|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152074|NCT01558271|P2|Participant Flow|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152075|NCT01558271|P1|Participant Flow|LY2189265|Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152076|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152077|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152078|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152079|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152080|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152081|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152082|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152083|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152084|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152085|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152086|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152087|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152088|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152089|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152090|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152176|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|
152091|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152092|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152093|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152094|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152095|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152096|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152097|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152098|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152099|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152100|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152101|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152102|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152103|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152104|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152105|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152106|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152107|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152108|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152109|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152110|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152111|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152112|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152113|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152114|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152115|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152116|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152117|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152118|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152119|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152120|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152121|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152122|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152123|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152124|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152125|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152126|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152127|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152128|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152129|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152130|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 24 weeks of open therapy.
152131|NCT01558271|O2|Outcome|Placebo|Once-weekly SC injection of placebo for 26 weeks of blinded therapy.
152132|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy.
152133|NCT01558271|E3|Reported Event|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
152134|NCT01558271|E2|Reported Event|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152135|NCT01558271|E1|Reported Event|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
152136|NCT01558128|B1|Baseline|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.
Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.
Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
152137|NCT01558128|P1|Participant Flow|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.
Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.
Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
152138|NCT01558128|O1|Outcome|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.
Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.
Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
152139|NCT01558128|E1|Reported Event|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.
Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.
Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
152140|NCT01558089|B1|Baseline|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
152141|NCT01558089|P1|Participant Flow|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
152142|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
153063|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
152144|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
152145|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
152146|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
152147|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
152148|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
152149|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
152177|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|
152150|NCT01558089|E1|Reported Event|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
152151|NCT01557959|B1|Baseline|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
152152|NCT01557959|P1|Participant Flow|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
152153|NCT01557959|O1|Outcome|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
152154|NCT01557959|E1|Reported Event|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
152155|NCT01557920|B1|Baseline|Crossover Randomized Propofol and Sevoflurane|"The healthy subject will be anesthetized with Propofol and Sevoflurane in a randomized crossover fashion. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.
Spontaneous swallows were identified, and categorized as physiological or pathological. Physiological swallows were followed by expiratory flow (E or I–E). Pathological swallows were followed by inspiration (I and E–I).
Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.
Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
152156|NCT01557920|P2|Participant Flow|Sevoflurane First, Then Propofol|"The healthy subject will be anesthetized first with Sevoflurane, and secondarily with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.
Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.
Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
152157|NCT01557920|P1|Participant Flow|Propofol First, Then Sevoflurane|"The healthy subject will be anesthetized first with Propofol, and secondarily with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.
Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.
Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
152158|NCT01557920|O2|Outcome|Wakefulness|
152159|NCT01557920|O1|Outcome|Anesthesia With Propofol and Sevoflurane|
152160|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|Duty cycle during anesthesia with propofol (during baseline CO2).
152161|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|Duty cycle during anesthesia with propofol (CO2 baseline).
152162|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|Duty cycle during anesthesia with sevoflurane (baseline CO2)
152163|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|Duty cycle during anesthesia with sevoflurane (during baseline CO2).
152164|NCT01557920|O1|Outcome|Wakefulness|Duty cycle (CO2 baseline)
152165|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|Minute Ventilation during anesthesia with propofol (during baseline CO2).
152166|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|Minute Ventilation during anesthesia with propofol (CO2 baseline).
152167|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|Minute ventilation during anesthesia with sevoflurane (baseline CO2)
152168|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|Minute ventilation during anesthesia with sevoflurane (during baseline CO2).
152169|NCT01557920|O1|Outcome|Wakefulness|Minute Ventilation (CO2 baseline)
152170|NCT01557920|O4|Outcome|Tonic Genioglossus Activity (Deep Anesthesia)|Tonic Genioglossus activity (deep anesthesia)
152171|NCT01557920|O3|Outcome|Phasic Genioglossus Activity (Deep Anesthesia)|Phasic activity (Peak activity - Tonic activity)
152172|NCT01557920|O2|Outcome|Tonic Genioglossus Activity (Light Anesthesia)|Tonic Genioglossus activity (light anesthesia)
152173|NCT01557920|O1|Outcome|Phasic Genioglossus Activity (Light Anesthesia)|Phasic activity (Peak activity - Tonic activity)
152178|NCT01557920|O1|Outcome|Wakefulness|
152179|NCT01557920|O6|Outcome|Wakefulness (With CO2 Insufflation)|Proportion of pathological (inspiratory) swallows during wakefulness (with CO2+4 and +8 insufflation).
152180|NCT01557920|O5|Outcome|Wakefulness (During Baseline CO2)|Proportion of pathological (inspiratory) swallows during anesthesia (during baseline CO2).
152181|NCT01557920|O4|Outcome|Anesthesia With Propofol and Sevoflurane (CO2 Insufflation)|Proportion of pathological (inspiratory) swallows during anesthesia (with CO2+4 and +8 insufflation).
152182|NCT01557920|O3|Outcome|Anesthesia With Propofol and Sevoflurane (Baseline CO2)|Proportion of pathological (inspiratory) swallows during anesthesia with propofol and sevoflurane (during baseline CO2).
152183|NCT01557920|O2|Outcome|Wakefulness (All Cases)|Proportion of pathological (inspiratory) swallows during wakefulness (across CO2 levels)
152184|NCT01557920|O1|Outcome|Anesthesia With Propofol and Sevoflurane (All Cases)|Proportion of pathological (inspiratory) swallows during anesthesia with propofol and sevoflurane (across carbon-dioxide (CO2) levels).
152185|NCT01557920|O2|Outcome|Sevoflurane|"The healthy subject will be anesthetized with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.
Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
152186|NCT01557920|O1|Outcome|Propofol|"The healthy subject will be anesthetized with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.
Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump."
152187|NCT01557920|E2|Reported Event|Sevoflurane|"The healthy subject will be anesthetized with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.
Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
152188|NCT01557920|E1|Reported Event|Propofol|"The healthy subject will be anesthetized with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.
Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump."
152189|NCT01557894|B3|Baseline|Total|Total of all reporting groups
152190|NCT01557894|B2|Baseline|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
152191|NCT01557894|B1|Baseline|Waitlist Control Group|Wait-list control group
152192|NCT01557894|P2|Participant Flow|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
152193|NCT01557894|P1|Participant Flow|Waitlist Control Group|"Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks.
Starting from week 10 these participants received the active intervention."
152194|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
152195|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
152196|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
152197|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
152198|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
152199|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
152200|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
152201|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
152202|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
152203|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants benefited from the active intervention.
152238|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.
N=20"
152204|NCT01557894|E2|Reported Event|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
152205|NCT01557894|E1|Reported Event|Waitlist Control Group|Wait-list control group
152206|NCT01557868|B3|Baseline|Total|Total of all reporting groups
152207|NCT01557868|B2|Baseline|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
152208|NCT01557868|B1|Baseline|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
152209|NCT01557868|P2|Participant Flow|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
152210|NCT01557868|P1|Participant Flow|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
152211|NCT01557868|O2|Outcome|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
152212|NCT01557868|O1|Outcome|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
152213|NCT01557868|O2|Outcome|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
152214|NCT01557868|O1|Outcome|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
152215|NCT01557868|E2|Reported Event|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
152216|NCT01557868|E1|Reported Event|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
152217|NCT01557842|B3|Baseline|Total|Total of all reporting groups
152218|NCT01557842|B2|Baseline|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
152219|NCT01557842|B1|Baseline|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
152220|NCT01557842|P2|Participant Flow|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
152221|NCT01557842|P1|Participant Flow|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
152222|NCT01557842|O2|Outcome|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
152223|NCT01557842|O1|Outcome|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
152224|NCT01557842|O2|Outcome|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
152225|NCT01557842|O1|Outcome|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
152226|NCT01557842|E2|Reported Event|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
152227|NCT01557842|E1|Reported Event|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
152228|NCT01557699|B4|Baseline|Total|Total of all reporting groups
152229|NCT01557699|B3|Baseline|Subcutaneous Meales Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.
N=20"
152230|NCT01557699|B2|Baseline|PMV SoloventTM|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20"
152231|NCT01557699|B1|Baseline|PMV Puffhaler®|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
N=20"
152232|NCT01557699|P3|Participant Flow|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.
N=20"
152233|NCT01557699|P2|Participant Flow|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20"
152234|NCT01557699|P1|Participant Flow|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
N=20"
152235|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.
N=20"
152236|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20"
152237|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
N=20"
152353|NCT01557348|B3|Baseline|Total|Total of all reporting groups
152239|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20"
152240|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
N=20"
152241|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.
N=20"
152242|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20"
152243|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
N=20"
152244|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.
N=20"
152245|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20"
152246|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
N=20"
152247|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.
N=20"
152248|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20"
152249|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
N=20"
152250|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.
N=20"
152251|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20"
152252|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
N=20"
152253|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.
N=20"
152254|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20"
152255|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
N=20"
152256|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.
N=20"
152257|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
N=20"
152258|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
N=20"
152259|NCT01557699|O3|Outcome|Subcutaneous Meales Vaccine|Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
152260|NCT01557699|O2|Outcome|PMV SoloventTM|Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
152261|NCT01557699|O1|Outcome|PMV Puffhaler®|Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
152262|NCT01557699|E3|Reported Event|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.
N=20"
152263|NCT01557699|E2|Reported Event|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine will be administered via SoloventTM device. A single dose of 10 mg will be used.
N=20"
152264|NCT01557699|E1|Reported Event|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.
N=20"
152265|NCT01555463|B3|Baseline|Total|Total of all reporting groups
152266|NCT01555463|B2|Baseline|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152267|NCT01555463|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
188177|NCT01421498|B1|Baseline|Lifitegrast 5.0%|
152268|NCT01555463|P2|Participant Flow|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152269|NCT01555463|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152270|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152271|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152272|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152273|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152274|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152275|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152276|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152277|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152278|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152279|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152280|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152281|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152282|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152283|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152284|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152285|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152286|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152287|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152288|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152289|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152290|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152291|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152292|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152293|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152294|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152295|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152296|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152297|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152298|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152299|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152300|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152301|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152302|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152303|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152304|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152305|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152306|NCT01555463|E2|Reported Event|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
152307|NCT01555463|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
152308|NCT01557595|B1|Baseline|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
152309|NCT01557595|P1|Participant Flow|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
152310|NCT01557595|O1|Outcome|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
152311|NCT01557595|E1|Reported Event|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
152354|NCT01557348|B2|Baseline|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152312|NCT01557582|B1|Baseline|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
152313|NCT01557582|P1|Participant Flow|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
152314|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
152315|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
152316|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
152317|NCT01557582|E1|Reported Event|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
152318|NCT01557569|B3|Baseline|Total|Total of all reporting groups
152319|NCT01557569|B2|Baseline|Placebo|"Group will receive placebo instead of atomoxetine
placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
152320|NCT01557569|B1|Baseline|Atomoxetine|"Group receiving atomoxetine
Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
152321|NCT01557569|P2|Participant Flow|Placebo|"Group will receive placebo instead of atomoxetine
placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
152322|NCT01557569|P1|Participant Flow|Atomoxetine|"Group receiving atomoxetine
Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
152323|NCT01557569|O2|Outcome|Placebo|"Group will receive placebo instead of atomoxetine
placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
152324|NCT01557569|O1|Outcome|Atomoxetine|"Group receiving atomoxetine
Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
152325|NCT01557569|E2|Reported Event|Placebo|"Group will receive placebo instead of atomoxetine
placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
152326|NCT01557569|E1|Reported Event|Atomoxetine|"Group receiving atomoxetine
Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
152327|NCT01557504|B3|Baseline|Total|Total of all reporting groups
152328|NCT01557504|B2|Baseline|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152329|NCT01557504|B1|Baseline|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152330|NCT01557504|P2|Participant Flow|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152331|NCT01557504|P1|Participant Flow|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152332|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152333|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152334|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152335|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152336|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152337|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152338|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152339|NCT01557504|O2|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152340|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152341|NCT01557504|O1|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152342|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152343|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152344|NCT01557504|O1|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152345|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152346|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152347|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 9.
152348|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 6.
152349|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 4.
152350|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
152351|NCT01557504|E2|Reported Event|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152352|NCT01557504|E1|Reported Event|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
152355|NCT01557348|B1|Baseline|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152356|NCT01557348|P2|Participant Flow|Alternative TNFi|Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152357|NCT01557348|P1|Participant Flow|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152358|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152359|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152360|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152361|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152362|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152363|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152364|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152365|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152366|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152367|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152368|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152369|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152370|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152371|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152372|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152373|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152374|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152375|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152376|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152377|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152378|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152379|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152380|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
188178|NCT01421498|P2|Participant Flow|Placebo|
152381|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152382|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152383|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152384|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152385|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
158091|NCT01530243|O2|Outcome|Terazosin|Terazosine: 2 mg BID
152386|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152387|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152388|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152389|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152390|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152391|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152392|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152393|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152394|NCT01557348|E2|Reported Event|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152395|NCT01557348|E1|Reported Event|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
152396|NCT01557322|B3|Baseline|Total|Total of all reporting groups
152397|NCT01557322|B2|Baseline|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152398|NCT01557322|B1|Baseline|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152399|NCT01557322|P2|Participant Flow|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152400|NCT01557322|P1|Participant Flow|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152401|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152402|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152403|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152404|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
153064|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
152405|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152406|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152558|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152559|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152407|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152408|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152409|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152410|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152411|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152412|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152413|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152414|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152415|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152416|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152417|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152418|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152419|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152420|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152421|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152422|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152423|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152424|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152425|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152426|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152427|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152428|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152429|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152430|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152431|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152432|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152433|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152434|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152435|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152436|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152437|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152438|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152439|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152440|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152441|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152442|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152443|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152444|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152445|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152446|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152447|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152448|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152449|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152450|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152451|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152452|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152453|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152454|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152455|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152456|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152457|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152458|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152459|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152460|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152461|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152462|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152463|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152464|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152465|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152466|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152467|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152468|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152469|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152470|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152471|NCT01557322|E2|Reported Event|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152472|NCT01557322|E1|Reported Event|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
152473|NCT01557283|B1|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
152474|NCT01557283|P1|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
152475|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
152476|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
152477|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
152478|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
152479|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
152480|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
152481|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
152544|NCT01556763|P1|Participant Flow|Placebo|Matching placebo was administered as one capsule per day for 21 days.
152545|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152546|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152482|NCT01557283|E1|Reported Event|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
152483|NCT01557166|B3|Baseline|Total|Total of all reporting groups
152484|NCT01557166|B2|Baseline|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
168642|NCT01486758|P1|Participant Flow|Placebo|Placebo for 14 days.
152485|NCT01557166|B1|Baseline|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152486|NCT01557166|P2|Participant Flow|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152487|NCT01557166|P1|Participant Flow|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152488|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152489|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152490|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152491|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152492|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152493|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152494|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152495|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152496|NCT01557166|E2|Reported Event|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152497|NCT01557166|E1|Reported Event|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
152498|NCT01556997|B4|Baseline|Total|Total of all reporting groups
152499|NCT01556997|B3|Baseline|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
152500|NCT01556997|B2|Baseline|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
152501|NCT01556997|B1|Baseline|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
152502|NCT01556997|P3|Participant Flow|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
152503|NCT01556997|P2|Participant Flow|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
152504|NCT01556997|P1|Participant Flow|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
152505|NCT01556997|O3|Outcome|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
152506|NCT01556997|O2|Outcome|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
152507|NCT01556997|O1|Outcome|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
152508|NCT01556997|O3|Outcome|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
152509|NCT01556997|O2|Outcome|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
152510|NCT01556997|O1|Outcome|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
152511|NCT01556997|E3|Reported Event|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
152512|NCT01556997|E2|Reported Event|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
152513|NCT01556997|E1|Reported Event|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
152547|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
152548|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152549|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152550|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
152514|NCT01556932|B1|Baseline|All Participants|"All participants go through Placebo-ABH or ABH-placebo depending on the sequence they were randomized to. Patients are randomized into Placebo-ABH or ABH-Placebo sequence.
Sequence 1:Patients apply Drug A gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug B. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug A. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol.
Sequence 2:Patients will apply Drug B gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug A. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug B. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol."
152515|NCT01556932|P2|Participant Flow|Placebo-ABH Gel|All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with Placebo first and then went to ABH gel. The randomization list will be generated by the Study Biostatistician.
152516|NCT01556932|P1|Participant Flow|ABH Gel- Placebo|All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with ABH gel first and then went to Placebo.The randomization list will be generated by the Study Biostatistician.
152517|NCT01556932|O2|Outcome|Placebo|Placebo applied topically for 2 minutes.
152518|NCT01556932|O1|Outcome|ABH Gel|ABH Gel applied topically for 2 minutes.
152519|NCT01556932|E1|Reported Event|Arm A and Arm B|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes and placebo topically over 2 minutes.
152520|NCT01556906|B1|Baseline|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152521|NCT01556906|P1|Participant Flow|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152522|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152523|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152524|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152525|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152526|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152527|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152528|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152529|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152530|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152531|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152532|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152533|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152534|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152535|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152536|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152537|NCT01556906|E1|Reported Event|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
152538|NCT01556763|B4|Baseline|Total|Total of all reporting groups
152539|NCT01556763|B3|Baseline|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152540|NCT01556763|B2|Baseline|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152541|NCT01556763|B1|Baseline|Placebo|Matching placebo was administered as one capsule per day for 21 days.
152542|NCT01556763|P3|Participant Flow|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152543|NCT01556763|P2|Participant Flow|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152551|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152552|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152553|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
152554|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152555|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152556|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
152557|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152560|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152561|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152562|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152563|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152564|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152565|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152566|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152567|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152568|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152569|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152570|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152571|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152572|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152573|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152574|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152575|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
152576|NCT01556763|E3|Reported Event|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
152577|NCT01556763|E2|Reported Event|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
152578|NCT01556763|E1|Reported Event|Placebo|Matching placebo was administered as one capsule per day for 21 days.
152579|NCT01556724|B3|Baseline|Total|Total of all reporting groups
152580|NCT01556724|B2|Baseline|0.1% Ropivacaine|"0.1% ropivacaine
Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
152581|NCT01556724|B1|Baseline|0.2% Ropivacaine|"0.2% ropivacaine
Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
152582|NCT01556724|P2|Participant Flow|0.1% Ropivacaine|"0.1% ropivacaine
Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
152599|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
152600|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152601|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
152583|NCT01556724|P1|Participant Flow|0.2% Ropivacaine|"0.2% ropivacaine
Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
152704|NCT01555931|E2|Reported Event|Control|"Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
152584|NCT01556724|O2|Outcome|0.1% Ropivacaine|"0.1% ropivacaine
Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
152585|NCT01556724|O1|Outcome|0.2% Ropivacaine|"0.2% ropivacaine
Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
152586|NCT01556724|E2|Reported Event|0.1% Ropivacaine Infusion in Nerve Block Catheter|"0.1% ropivacaine
Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
152587|NCT01556724|E1|Reported Event|0.2% Ropivacaine|"0.2% ropivacaine
Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
152588|NCT01556633|B3|Baseline|Total|Total of all reporting groups
152589|NCT01556633|B2|Baseline|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
152590|NCT01556633|B1|Baseline|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152591|NCT01556633|P2|Participant Flow|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
152592|NCT01556633|P1|Participant Flow|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152593|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
152594|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152595|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
152596|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152597|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
152598|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
188179|NCT01421498|P1|Participant Flow|Lifitegrast 5.0%|
152602|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152603|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152604|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
152605|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152606|NCT01556633|O1|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
152607|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152608|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
152609|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152610|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152611|NCT01556633|E2|Reported Event|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
152612|NCT01556633|E1|Reported Event|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
152613|NCT01556594|B4|Baseline|Total|Total of all reporting groups
152614|NCT01556594|B3|Baseline|Group 3|Med dose IN followed by SC injection followed by high dose IN of glucagon
152615|NCT01556594|B2|Baseline|Group 2|Low dose IN followed by med dose IN followed by SC injection followed by high dose IN of glucagon
152616|NCT01556594|B1|Baseline|Group 1|Low dose IN followed by med dose IN followed by SC injection of glucagon
152617|NCT01556594|P3|Participant Flow|Gp 3: Med Dose IN, SC, High Dose IN|Med dose IN followed by SC followed by high dose IN glucagon
152618|NCT01556594|P2|Participant Flow|Gp 2: Low Dose IN, Med Dose IN, SC, High Dose IN|Low dose IN followed by medium dose IN followed by SC followed by high dose IN glucagon
152619|NCT01556594|P1|Participant Flow|Gp 1: Low Dose IN, Med Dose IN, SC|Low dose IN followed by med dose IN followed by SC injection of glucagon
152620|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
152621|NCT01556594|O3|Outcome|High Dose Novel Form'n|High dose novel formulation
152622|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
152623|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
152624|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
152625|NCT01556594|O3|Outcome|High Dose Novel Form'n|high dose novel formulation
152626|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
152627|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
152628|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
152629|NCT01556594|O3|Outcome|High Dose Novel Form'n|High dose novel formulation
152630|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
152631|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
152632|NCT01556594|E4|Reported Event|Medium Dose Novel Form'n|Medium dose novel formulation
152633|NCT01556594|E3|Reported Event|High Dose Novel Form'n|high dose novel formulation
152634|NCT01556594|E2|Reported Event|Low Dose Novel Form'n|Low dose novel formulation
152635|NCT01556594|E1|Reported Event|SC Glucagon Injection|SC glucagon injection 1 mg
152636|NCT01556451|B1|Baseline|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
152637|NCT01556451|P1|Participant Flow|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
152638|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
152639|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
152640|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
152641|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
152642|NCT01556451|E1|Reported Event|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
152643|NCT01556204|B3|Baseline|Total|Total of all reporting groups
152644|NCT01556204|B2|Baseline|Laparoscopic|Laparoscopic surgery
152645|NCT01556204|B1|Baseline|Robotic|Robotic surgery
152646|NCT01556204|P2|Participant Flow|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.
Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
152647|NCT01556204|P1|Participant Flow|Robotic Surgery|"da Vinci Surgical System
Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
152705|NCT01555931|E1|Reported Event|Immediate|"Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
152648|NCT01556204|O2|Outcome|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.
Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
152649|NCT01556204|O1|Outcome|Robotic Surgery|"da Vinci Surgical System
Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
152650|NCT01556204|O2|Outcome|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.
Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
152651|NCT01556204|O1|Outcome|Robotic Surgery|"da Vinci Surgical System
Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
152652|NCT01556204|E2|Reported Event|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.
Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
152653|NCT01556204|E1|Reported Event|Robotic Surgery|"da Vinci Surgical System
Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
152654|NCT01556165|B3|Baseline|Total|Total of all reporting groups
152655|NCT01556165|B2|Baseline|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
152656|NCT01556165|B1|Baseline|Placebo|placebo: tablets, once daily, orally
152657|NCT01556165|P2|Participant Flow|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
152658|NCT01556165|P1|Participant Flow|Placebo|placebo: tablets, once daily, orally
152659|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
152660|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
152661|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
152662|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
152663|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
152664|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
152665|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
152666|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
152667|NCT01556165|E2|Reported Event|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
152668|NCT01556165|E1|Reported Event|Placebo|placebo: tablets, once daily, orally
152669|NCT01556061|B3|Baseline|Total|Total of all reporting groups
152670|NCT01556061|B2|Baseline|D-MAC First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
152671|NCT01556061|B1|Baseline|C-MAC First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
152706|NCT01555164|B3|Baseline|Total|Total of all reporting groups
152672|NCT01556061|P2|Participant Flow|D-MAC First, Then CMAC Video Laryngoscopy|D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
152673|NCT01556061|P1|Participant Flow|C-MAC First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
152674|NCT01556061|O2|Outcome|D-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
152675|NCT01556061|O1|Outcome|C-MAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
152676|NCT01556061|O2|Outcome|D-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
152677|NCT01556061|O1|Outcome|C-MAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
152678|NCT01556061|O2|Outcome|D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
152679|NCT01556061|O1|Outcome|C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
152680|NCT01556061|E2|Reported Event|DMAC Laryngoscopy First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
152681|NCT01556061|E1|Reported Event|C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
152682|NCT01555983|B1|Baseline|All Study Participants|All participants received all interventions
152683|NCT01555983|P6|Participant Flow|6.7%THC First, Then 2.9%THC, Then Placebo|6.7%THC in am of first intervention visit, then 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
152684|NCT01555983|P5|Participant Flow|6.7%THC First, Then Placebo, Then 2.9%THC|6.7%THC in am of first intervention visit, then placebo in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).
152685|NCT01555983|P4|Participant Flow|2.9%THC First, Then 6.7%THC, Then Placebo|2.9%THC in am of first intervention visit, then 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
152686|NCT01555983|P3|Participant Flow|2.9%THC First, Then Placebo, Then 6.7%THC|2.9%THC in am of first intervention visit, placebo in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC am of third intervention visit (after 3-10 day washout period)
152687|NCT01555983|P2|Participant Flow|Placebo First, Then 6.7%THC, Then 2.9%THC|Placebo in am of first intervention visit, 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).
152688|NCT01555983|P1|Participant Flow|Placebo First, Then 2.9%THC, Then 6.7% THC|Placebo in am of first intervention visit, 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC in am of third intervention visit (after 3-10 day washout period).
152689|NCT01555983|O3|Outcome|6.7% THC|Vaporization of Cannabis 6.7% THC
152690|NCT01555983|O2|Outcome|2.9% THC|Vaporization of Cannabis 2.9% THC
152691|NCT01555983|O1|Outcome|Placebo THC|Session at which placebo THC was administered
152692|NCT01555983|E3|Reported Event|6.7% THC|Vaporization of Cannabis 6.7% THC
152693|NCT01555983|E2|Reported Event|2.9% THC|Vaporization of Cannabis 2.9% THC
152694|NCT01555983|E1|Reported Event|Placebo THC|Vaporization of Cannabis Placebo THC
152695|NCT01555931|B3|Baseline|Total|Total of all reporting groups
152696|NCT01555931|B2|Baseline|Control|"Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
152697|NCT01555931|B1|Baseline|Immediate|"Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
152698|NCT01555931|P2|Participant Flow|Control|"Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
152699|NCT01555931|P1|Participant Flow|Immediate|"Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
152700|NCT01555931|O2|Outcome|Control|"Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
152701|NCT01555931|O1|Outcome|Immediate|"Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
152702|NCT01555931|O2|Outcome|Control|"Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
152703|NCT01555931|O1|Outcome|Immediate|"Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
152707|NCT01555164|B2|Baseline|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.
Participants were required to maintain their diet and exercise regimen."
152708|NCT01555164|B1|Baseline|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.
Participants were required to maintain their diet and exercise regimen."
152709|NCT01555164|P2|Participant Flow|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.
Participants were required to maintain their diet and exercise regimen."
152710|NCT01555164|P1|Participant Flow|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.
Participants were required to maintain their diet and exercise regimen."
152711|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.
Participants were required to maintain their diet and exercise regimen."
152712|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.
Participants were required to maintain their diet and exercise regimen."
152713|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.
Participants were required to maintain their diet and exercise regimen."
152714|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.
Participants were required to maintain their diet and exercise regimen."
152715|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.
Participants were required to maintain their diet and exercise regimen."
152887|NCT01554241|O1|Outcome|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day"
152716|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.
Participants were required to maintain their diet and exercise regimen."
152754|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152755|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152756|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152717|NCT01555164|E2|Reported Event|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.
Participants were required to maintain their diet and exercise regimen."
152718|NCT01555164|E1|Reported Event|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.
Participants were required to maintain their diet and exercise regimen."
152719|NCT01555151|B5|Baseline|Total|Total of all reporting groups
152720|NCT01555151|B4|Baseline|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152721|NCT01555151|B3|Baseline|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152722|NCT01555151|B2|Baseline|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152723|NCT01555151|B1|Baseline|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152724|NCT01555151|P4|Participant Flow|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152725|NCT01555151|P3|Participant Flow|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152726|NCT01555151|P2|Participant Flow|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152727|NCT01555151|P1|Participant Flow|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152728|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152729|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152730|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152731|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152732|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152733|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152734|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152735|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152736|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152737|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152738|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152739|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152740|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152741|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152742|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152743|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152744|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152745|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152746|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152747|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152748|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152749|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152750|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
188180|NCT01421498|O2|Outcome|Placebo|
152751|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152752|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152753|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152757|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152758|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152759|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152760|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152761|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152762|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152763|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152764|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152765|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152766|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152767|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152768|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152769|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152770|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152771|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152772|NCT01555151|E5|Reported Event|Total|Total
152773|NCT01555151|E4|Reported Event|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
152774|NCT01555151|E3|Reported Event|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
152775|NCT01555151|E2|Reported Event|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
152776|NCT01555151|E1|Reported Event|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
152777|NCT01555138|B3|Baseline|Total|Total of all reporting groups
152778|NCT01555138|B2|Baseline|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152779|NCT01555138|B1|Baseline|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152780|NCT01555138|P2|Participant Flow|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152781|NCT01555138|P1|Participant Flow|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152782|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152783|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152784|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152785|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152786|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152787|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152788|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152789|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152790|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152791|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152792|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152793|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152794|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152795|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152796|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152797|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152798|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152799|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152800|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152801|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152802|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152803|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152804|NCT01555138|E2|Reported Event|Salmeterol/Fluticasone|Salmeterol 50 μg /fluticasone propionate 500 μg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
152805|NCT01555138|E1|Reported Event|Indacaterol|Indacaterol 150 μg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
152806|NCT01555073|B5|Baseline|Total|Total of all reporting groups
152807|NCT01555073|B4|Baseline|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
152808|NCT01555073|B3|Baseline|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.
celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
152809|NCT01555073|B2|Baseline|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.
pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
152810|NCT01555073|B1|Baseline|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.
pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
152811|NCT01555073|P4|Participant Flow|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
152812|NCT01555073|P3|Participant Flow|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.
celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
152813|NCT01555073|P2|Participant Flow|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.
pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
152814|NCT01555073|P1|Participant Flow|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.
pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
152815|NCT01555073|O4|Outcome|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
152816|NCT01555073|O3|Outcome|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.
celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
152817|NCT01555073|O2|Outcome|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.
pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
152818|NCT01555073|O1|Outcome|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.
pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
152819|NCT01555073|O4|Outcome|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
152820|NCT01555073|O3|Outcome|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.
celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
152821|NCT01555073|O2|Outcome|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.
pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
152822|NCT01555073|O1|Outcome|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.
pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
152823|NCT01555073|E4|Reported Event|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
152824|NCT01555073|E3|Reported Event|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.
celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
152825|NCT01555073|E2|Reported Event|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.
pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
152826|NCT01555073|E1|Reported Event|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.
pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
152827|NCT01554982|B1|Baseline|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152828|NCT01554982|P1|Participant Flow|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152829|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
154350|NCT01545700|O1|Outcome|Placebo 0-4 Hours-baseline|Placebo 0-4 hours baseline
152830|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152831|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152832|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152833|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152834|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152835|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152836|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152837|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152838|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152839|NCT01554982|E1|Reported Event|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
152840|NCT01554904|B1|Baseline|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
152841|NCT01554904|P1|Participant Flow|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
152842|NCT01554904|O1|Outcome|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
152843|NCT01554904|O1|Outcome|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
152844|NCT01554904|E1|Reported Event|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
152845|NCT01554891|B4|Baseline|Total|Total of all reporting groups
152846|NCT01554891|B3|Baseline|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
152847|NCT01554891|B2|Baseline|Comparison of SAFE-TBI and VA Screen|100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen
152848|NCT01554891|B1|Baseline|Test-Retest Reliability of SAFE-TBI|100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen
152849|NCT01554891|P3|Participant Flow|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
152888|NCT01554241|E4|Reported Event|50,000 IU/Week D3|"D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
152850|NCT01554891|P2|Participant Flow|Comparison of SAFE-TBI and VA Screen|"100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI.
Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI."
152894|NCT01554176|B1|Baseline|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
152927|NCT01554163|P1|Participant Flow|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
152851|NCT01554891|P1|Participant Flow|Test-Retest Reliability of SAFE-TBI|"100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen.
This component of the project assessed test-retest reliability (4-6 weeks), as well as the eﬀects of diﬀerent raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 2)."
152852|NCT01554891|O1|Outcome|Sensitivity and Specificity of SAFE-TBI|Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives)
152853|NCT01554891|O1|Outcome|Comparison of SAFE-TBI and VA Screen|Veterans
152854|NCT01554891|O1|Outcome|Test-Retest Reliability of SAFE-TBI|Cohort 1 was used to determine test-retest reliability of the SAFE-TBI instrument.
152855|NCT01554891|E3|Reported Event|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
152856|NCT01554891|E2|Reported Event|Comparison of SAFE-TBI and VA Screen|"100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI.
Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI."
152857|NCT01554891|E1|Reported Event|Test-Retest Reliability of SAFE-TBI|"100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen.
This component of the project assessed test-retest reliability (4-6 weeks), as well as the eﬀects of diﬀerent raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 2)."
152858|NCT01554579|B3|Baseline|Total|Total of all reporting groups
152859|NCT01554579|B2|Baseline|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
152860|NCT01554579|B1|Baseline|Sugar Pill|Sugar Pill: Placebo
152861|NCT01554579|P2|Participant Flow|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
152862|NCT01554579|P1|Participant Flow|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
152863|NCT01554579|O2|Outcome|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
152864|NCT01554579|O1|Outcome|Sugar Pill|Sugar Pill: Placebo
152865|NCT01554579|O2|Outcome|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
152866|NCT01554579|O1|Outcome|Sugar Pill|Sugar Pill: Placebo
152867|NCT01554579|O2|Outcome|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
152868|NCT01554579|O1|Outcome|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
152869|NCT01554579|E2|Reported Event|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
152870|NCT01554579|E1|Reported Event|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
152871|NCT01554241|B5|Baseline|Total|Total of all reporting groups
152872|NCT01554241|B4|Baseline|50,000 IU/Week D3|"D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
152873|NCT01554241|B3|Baseline|Vitamin D3 4000 IU/Day|"D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day"
152874|NCT01554241|B2|Baseline|2000 IU/Day D3|"D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3"
152875|NCT01554241|B1|Baseline|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day"
152876|NCT01554241|P4|Participant Flow|50,000 IU/Week D3|"D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
152877|NCT01554241|P3|Participant Flow|Vitamin D3 4000 IU/Day|"D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day"
152878|NCT01554241|P2|Participant Flow|2000 IU/Day D3|"D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3"
152879|NCT01554241|P1|Participant Flow|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day"
152880|NCT01554241|O4|Outcome|50,000 IU/Week D3|"D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
152881|NCT01554241|O3|Outcome|Vitamin D3 4000 IU/Day|"D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day"
152882|NCT01554241|O2|Outcome|2000 IU/Day D3|"D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3"
152883|NCT01554241|O1|Outcome|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day"
152884|NCT01554241|O4|Outcome|50,000 IU/Week D3|"D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
152885|NCT01554241|O3|Outcome|Vitamin D3 4000 IU/Day|"D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day"
152886|NCT01554241|O2|Outcome|2000 IU/Day D3|"D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3"
152889|NCT01554241|E3|Reported Event|Vitamin D3 4000 IU/Day|"D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day"
152890|NCT01554241|E2|Reported Event|2000 IU/Day D3|"D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3"
152891|NCT01554241|E1|Reported Event|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day"
152892|NCT01554176|B3|Baseline|Total|Total of all reporting groups
152893|NCT01554176|B2|Baseline|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
152895|NCT01554176|P5|Participant Flow|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
152896|NCT01554176|P4|Participant Flow|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
152897|NCT01554176|P3|Participant Flow|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
152898|NCT01554176|P2|Participant Flow|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
152899|NCT01554176|P1|Participant Flow|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
152900|NCT01554176|O3|Outcome|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
152901|NCT01554176|O2|Outcome|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
152902|NCT01554176|O1|Outcome|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
152903|NCT01554176|O3|Outcome|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
152904|NCT01554176|O2|Outcome|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
152905|NCT01554176|O1|Outcome|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
152906|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
152907|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
152908|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
152909|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
152910|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
152911|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
152912|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
152913|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
152914|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
152915|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
152916|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
152917|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
152918|NCT01554176|E5|Reported Event|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the treatment phase.
152919|NCT01554176|E4|Reported Event|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
152920|NCT01554176|E3|Reported Event|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
152957|NCT01553708|B2|Baseline|Silver Zinc Sulfadiazine Cream|
152921|NCT01554176|E2|Reported Event|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
152922|NCT01554176|E1|Reported Event|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
152923|NCT01554163|B3|Baseline|Total|Total of all reporting groups
152924|NCT01554163|B2|Baseline|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
152925|NCT01554163|B1|Baseline|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
152926|NCT01554163|P2|Participant Flow|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
152928|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
152929|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
152930|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
152931|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
152932|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
152933|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
152934|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
152935|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
152936|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
152937|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
152938|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
152939|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
152940|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
152941|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
152942|NCT01554163|E2|Reported Event|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
152943|NCT01554163|E1|Reported Event|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
152944|NCT01553851|B1|Baseline|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152945|NCT01553851|P1|Participant Flow|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152946|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152947|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152948|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152949|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152950|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152951|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152952|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152953|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152954|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152955|NCT01553851|E1|Reported Event|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
152956|NCT01553708|B3|Baseline|Total|Total of all reporting groups
152961|NCT01553708|O2|Outcome|Silver Zinc Sulfadiazine Cream|Wounds treated with the cream containing silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
152962|NCT01553708|O1|Outcome|Epidermal Growth Factor With Silver Sulfadiazine Cream|Wounds treated with the cream containing epidermal growth factor and silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
152963|NCT01553708|E2|Reported Event|Silver Zinc Sulfadiazine Cream|
152964|NCT01553708|E1|Reported Event|Epidermal Growth Factor With Silver Sulfadiazine Cream|
152965|NCT01553539|B1|Baseline|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
152966|NCT01553539|P1|Participant Flow|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) subcutaneous (SC) once daily in the absence of disease progression or unacceptable toxicity.
152967|NCT01553539|O1|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
152968|NCT01553539|O1|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
152969|NCT01553539|E1|Reported Event|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
152970|NCT01553318|B3|Baseline|Total|Total of all reporting groups
152971|NCT01553318|B2|Baseline|Placebo|Participants who received the placebo
152972|NCT01553318|B1|Baseline|Ketotifen Group|Participants who received the active drug - ketotifen
152973|NCT01553318|P2|Participant Flow|Placebo|Placebo medication
152974|NCT01553318|P1|Participant Flow|Ketotifen|ketotifen active group
152975|NCT01553318|O2|Outcome|Placebo|placebo group
152976|NCT01553318|O1|Outcome|Ketotifen|active drug group
152977|NCT01553318|O2|Outcome|Placebo|placebo group
152978|NCT01553318|O1|Outcome|Ketotifen|active drug group
152979|NCT01553318|O2|Outcome|Placebo|placebo group
152980|NCT01553318|O1|Outcome|Ketotifen|active drug group
152981|NCT01553318|O2|Outcome|Placebo|received placebo
152982|NCT01553318|O1|Outcome|Ketotifen|Ketotifen active drug
152983|NCT01553318|E2|Reported Event|Placebo|received placebo
152984|NCT01553318|E1|Reported Event|Ketotifen|Received ketotifen the active drug
152985|NCT01553292|B1|Baseline|Angiocath Surfactant|Preterm infants born at 24 to 34 weeks of postmenstrual gestational age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152986|NCT01553292|P1|Participant Flow|Surfactant Through Vascular Catheter|Preterm infants born between 24 to 34 weeks postmenstrual gestation were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)during 1st 24 hours of life
152987|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152988|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152989|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152990|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152991|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152992|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152993|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152994|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152995|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants between 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152996|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152997|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152998|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants born between 24 to 34 weeks post-menstrual age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
152999|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
153000|NCT01553292|E1|Reported Event|Angiocath Surfactant|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
153065|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
153066|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
153067|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
153001|NCT01553240|B1|Baseline|TMS and fMRI|"functional MRI
single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)
TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
153002|NCT01553240|P1|Participant Flow|TMS and fMRI|"functional MRI
single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)
TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
154351|NCT01545700|O6|Outcome|Dexamethasone 8 mg 8-24 Hours|
153003|NCT01553240|O1|Outcome|TMS and fMRI|"functional MRI
single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)
TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
153004|NCT01553240|O1|Outcome|TMS and fMRI|"functional MRI
single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)
TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
153005|NCT01553240|E1|Reported Event|TMS and fMRI|"functional MRI
single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)
TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
153006|NCT01552954|B3|Baseline|Total|Total of all reporting groups
153007|NCT01552954|B2|Baseline|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.
Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
153008|NCT01552954|B1|Baseline|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
153009|NCT01552954|P2|Participant Flow|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.
Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
153010|NCT01552954|P1|Participant Flow|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
153011|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.
Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
153012|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
153013|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.
Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
153014|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
153015|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.
Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
153016|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
153017|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.
Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
153018|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
153019|NCT01552954|E2|Reported Event|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.
Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
153020|NCT01552954|E1|Reported Event|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
153021|NCT01552928|B5|Baseline|Total|Total of all reporting groups
153022|NCT01552928|B4|Baseline|Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg|A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
153023|NCT01552928|B3|Baseline|Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg|A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
153024|NCT01552928|B2|Baseline|Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo|A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
153025|NCT01552928|B1|Baseline|Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg|A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
153026|NCT01552928|P4|Participant Flow|Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg|A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
153027|NCT01552928|P3|Participant Flow|Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg|A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
153028|NCT01552928|P2|Participant Flow|Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo|A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
153029|NCT01552928|P1|Participant Flow|Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg|A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
153030|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
153031|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
153032|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
153033|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
153034|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
153035|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
153036|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
153037|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
153038|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
153039|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
153040|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
153041|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
153042|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
153043|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
153044|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
153045|NCT01552928|O2|Outcome|BCH24426 (Females)|Metabolite from a single oral dose of 2.5 mg of anagrelide
153046|NCT01552928|O1|Outcome|BCH24426 (Males)|Metabolite from a single oral dose of 2.5 mg of anagrelide
153047|NCT01552928|O2|Outcome|BCH24426 (Females)|Metabolite from a single oral dose of 0.5 mg of anagrelide
153048|NCT01552928|O1|Outcome|BCH24426 (Males)|Metabolite from a single oral dose of 0.5 mg of anagrelide
153049|NCT01552928|O2|Outcome|Anagrelide 2.5mg (Females)|A single oral dose of 2.5 mg of anagrelide
153050|NCT01552928|O1|Outcome|Anagrelide 2.5mg (Males)|A single oral dose of 2.5 mg of anagrelide
153051|NCT01552928|O2|Outcome|Anagrelide 0.5 mg (Females)|A single oral dose of 0.5 mg of anagrelide
153052|NCT01552928|O1|Outcome|Anagrelide 0.5 mg (Males)|A single oral dose of 0.5 mg of anagrelide
153053|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
153054|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
153055|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
153056|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
153057|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
153058|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
153059|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
153060|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
153061|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
153073|NCT01552915|B3|Baseline|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
153074|NCT01552915|B2|Baseline|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
153075|NCT01552915|B1|Baseline|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
153076|NCT01552915|P3|Participant Flow|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
153077|NCT01552915|P2|Participant Flow|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day
154352|NCT01545700|O5|Outcome|Dexamethasone 4 mg 8-24 Hours|
153078|NCT01552915|P1|Participant Flow|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
153079|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
153080|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
153081|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
153082|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
153083|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
153084|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
153085|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
153086|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
153087|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
153088|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
153089|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
153090|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
153091|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
153092|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
153093|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
153094|NCT01552915|E3|Reported Event|OROS-MPH|Subjects received over encapsulated OROS-MPH optimized among a 18, 36, 54 or 72mg dose. Subjects optimized to 72mg received two 36mg tablets.
153095|NCT01552915|E2|Reported Event|SPD489|Subjects received over encapsulated SPD489 optimized among a 30, 50, or 70mg dose.
153096|NCT01552915|E1|Reported Event|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
153097|NCT01552902|B4|Baseline|Total|Total of all reporting groups
153098|NCT01552902|B3|Baseline|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
153099|NCT01552902|B2|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
153100|NCT01552902|B1|Baseline|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
153101|NCT01552902|P3|Participant Flow|Methylphenidate|Methylphenidate (Concerta, Osmotic controlled oral release delivery system-methylphenidate [OROS-MPH]) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
153102|NCT01552902|P2|Participant Flow|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 milligram (mg) over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
153103|NCT01552902|P1|Participant Flow|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
153104|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
153105|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
153106|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
153107|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
153108|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
153109|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
153202|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153203|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153110|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
153111|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
153112|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
153113|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
153114|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
153115|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
153116|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
153117|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
153118|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
153119|NCT01552902|E3|Reported Event|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
153120|NCT01552902|E2|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
153121|NCT01552902|E1|Reported Event|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
153122|NCT01552889|B3|Baseline|Total|Total of all reporting groups
153123|NCT01552889|B2|Baseline|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.
Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
153124|NCT01552889|B1|Baseline|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
153125|NCT01552889|P2|Participant Flow|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.
Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
153126|NCT01552889|P1|Participant Flow|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
153127|NCT01552889|O2|Outcome|Collaborative Care|Same as above
153128|NCT01552889|O1|Outcome|Usual Care|Same as above
153129|NCT01552889|O2|Outcome|Collaborative Care|Same as above
153130|NCT01552889|O1|Outcome|Usual Care|Same as above
153131|NCT01552889|O2|Outcome|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.
Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
153132|NCT01552889|O1|Outcome|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
154305|NCT01545765|O4|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time|
153161|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153133|NCT01552889|E2|Reported Event|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.
Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
153134|NCT01552889|E1|Reported Event|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
153135|NCT01552876|B1|Baseline|All Subjects|All subjects who were enrolled at baseline.
153136|NCT01552876|P2|Participant Flow|Nelfilcon A/ Etafilcon A/ Filcon II 3|nelfilcon A worn first, etafilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).
153137|NCT01552876|P1|Participant Flow|Etafilcon A/ Nelfilcon A/Filcon II 3|etafilcon A worn first, nelfilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).
153138|NCT01552876|O3|Outcome|Filcon II 3|All subjects wore the Filcon II 3 lens after the wearing of the etafilcon and nelfilcon lenses.
153139|NCT01552876|O2|Outcome|Nelfilcon A|Those who wore Nelfilcon A
153140|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
153141|NCT01552876|O2|Outcome|Nelfilcon A|Those subjects who wore nelfilcon A.
153142|NCT01552876|O1|Outcome|Etafilcon A|Those subjects who wore etafilcon A.
153143|NCT01552876|O2|Outcome|Nelfilcon A.|Those who wore nelfilcon A.
153144|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
153145|NCT01552876|O2|Outcome|Nelfilcon A|Those who wore nelfilcon A.
153146|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
153147|NCT01552876|O2|Outcome|Nelfilcon A|Those subjects who wore nelfilcon A.
153148|NCT01552876|O1|Outcome|Etafilcon A|Those subjects who wore etafilcon A.
153149|NCT01552876|E3|Reported Event|Filcon II 3|Those who wore Filcon II 3 during Phase II
153150|NCT01552876|E2|Reported Event|Nelfilcon A|Those subjects who wore nelfilcon A. (Phase I & II)
153151|NCT01552876|E1|Reported Event|Etafilcon A|Those subjects who wore etafilcon A. (Phase I & II)
153152|NCT01552772|B1|Baseline|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153153|NCT01552772|P1|Participant Flow|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153154|NCT01552772|O1|Outcome|Total|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153155|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153156|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153157|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153158|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153159|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153160|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153162|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153163|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153164|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153165|NCT01552772|E1|Reported Event|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
153166|NCT01552694|B3|Baseline|Total|Total of all reporting groups
153167|NCT01552694|B2|Baseline|Placebo|"Matching placebo daily for 2 months
Placebo: oral, matching placebo daily for 2 months"
153168|NCT01552694|B1|Baseline|Sitagliptin|"100 mg sitagliptin/day for 2 months
Sitagliptin: Oral, 100 mg/day for 2 months"
153169|NCT01552694|P2|Participant Flow|Placebo|"Matching placebo daily for 2 months
Placebo: oral, matching placebo daily for 2 months"
153170|NCT01552694|P1|Participant Flow|Sitagliptin|"100 mg sitagliptin/day for 2 months
Sitagliptin: Oral, 100 mg/day for 2 months"
153171|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months
Placebo: oral, matching placebo daily for 2 months"
153172|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months
Sitagliptin: Oral, 100 mg/day for 2 months"
153173|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months
Placebo: oral, matching placebo daily for 2 months"
153174|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months
Sitagliptin: Oral, 100 mg/day for 2 months"
153175|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months
Placebo: oral, matching placebo daily for 2 months"
153176|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months
Sitagliptin: Oral, 100 mg/day for 2 months"
153177|NCT01552694|E2|Reported Event|Placebo|"Matching placebo daily for 2 months
Placebo: oral, matching placebo daily for 2 months"
153178|NCT01552694|E1|Reported Event|Sitagliptin|"100 mg sitagliptin/day for 2 months
Sitagliptin: Oral, 100 mg/day for 2 months"
153179|NCT01552681|B3|Baseline|Total|Total of all reporting groups
153180|NCT01552681|B2|Baseline|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153181|NCT01552681|B1|Baseline|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153182|NCT01552681|P2|Participant Flow|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153183|NCT01552681|P1|Participant Flow|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153184|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153185|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153186|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153187|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153188|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153189|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153190|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153191|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153192|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153193|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153194|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153195|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153196|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153197|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153198|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153199|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153200|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153201|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153204|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153205|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153206|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153207|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153208|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153209|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153210|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153211|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153212|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153213|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153214|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153215|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153216|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153217|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153218|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153219|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153220|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153221|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153222|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153223|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153224|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153225|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153226|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153227|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153228|NCT01552681|E2|Reported Event|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
153229|NCT01552681|E1|Reported Event|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
153230|NCT01552603|B1|Baseline|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
153231|NCT01552603|P1|Participant Flow|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
153232|NCT01552603|O1|Outcome|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
153233|NCT01552603|O1|Outcome|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
154353|NCT01545700|O4|Outcome|Placebo 8-24 Hours|
153234|NCT01552603|E1|Reported Event|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
153235|NCT01552343|B3|Baseline|Total|Total of all reporting groups
153236|NCT01552343|B2|Baseline|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153237|NCT01552343|B1|Baseline|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153238|NCT01552343|P2|Participant Flow|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153239|NCT01552343|P1|Participant Flow|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153240|NCT01552343|O4|Outcome|Male - Desmopressin 75 μg|Male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153241|NCT01552343|O3|Outcome|Female - Desmopressin 25 μg|Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153242|NCT01552343|O2|Outcome|Male - Placebo|Male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153243|NCT01552343|O1|Outcome|Female - Placebo|Female participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153244|NCT01552343|O4|Outcome|Male - Desmopressin 75 μg|Male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153245|NCT01552343|O3|Outcome|Female - Desmopressin 25 μg|Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153246|NCT01552343|O2|Outcome|Male - Placebo|Male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153247|NCT01552343|O1|Outcome|Female - Placebo|Female participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153248|NCT01552343|O2|Outcome|Placebo|Participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153249|NCT01552343|O1|Outcome|Desmopressin|Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month. Male participants took 1 tablet of 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153250|NCT01552343|O2|Outcome|>= 3 Voids|Study participants who had >=3 voids average from the screening and baseline diaries.
153251|NCT01552343|O1|Outcome|< 3 Voids|Study participants who had <3 voids average from the screening and baseline diaries.
153252|NCT01552343|O1|Outcome|All Participants|All study participants
153253|NCT01552343|O1|Outcome|All Participants|All study participants
153254|NCT01552343|O2|Outcome|Responders|Participants who experienced a reduction from baseline of >=33% in nocturnal voids at the Month 1
153255|NCT01552343|O1|Outcome|Non-Responders|Participants who experienced a reduction from baseline of <33% in nocturnal voids at the Month 1
153256|NCT01552343|O1|Outcome|All Participants|All study participants
153257|NCT01552343|E2|Reported Event|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153258|NCT01552343|E1|Reported Event|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
153259|NCT01552057|B3|Baseline|Total|Total of all reporting groups
153260|NCT01552057|B2|Baseline|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
153261|NCT01552057|B1|Baseline|Duloxetine 60 mg|"Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
153286|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153262|NCT01552057|P2|Participant Flow|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
153287|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153263|NCT01552057|P1|Participant Flow|Duloxetine 60 mg|"Treatment Period: Up to 60-milligram (mg) dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
153264|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153265|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153266|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153267|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153268|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153269|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153270|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153271|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153272|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153273|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153274|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153275|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153276|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153277|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153278|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153279|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153280|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153281|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153282|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153283|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153284|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153285|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
154306|NCT01545765|O3|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - First Application Time|
153288|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153401|NCT01551355|E2|Reported Event|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
153289|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153290|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
153291|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
153292|NCT01552057|E2|Reported Event|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
153293|NCT01552057|E1|Reported Event|Duloxetine 60 mg|"Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
153294|NCT01551979|B3|Baseline|Total|Total of all reporting groups
153295|NCT01551979|B2|Baseline|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153296|NCT01551979|B1|Baseline|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153297|NCT01551979|P2|Participant Flow|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153298|NCT01551979|P1|Participant Flow|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153299|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153300|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153301|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153302|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153303|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153304|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153305|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
188181|NCT01421498|O1|Outcome|Lifitegrast 5.0%|
153306|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
154144|NCT01546636|P2|Participant Flow|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
153307|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153308|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153309|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153310|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153311|NCT01551979|E2|Reported Event|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153312|NCT01551979|E1|Reported Event|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group."
153313|NCT01551888|B1|Baseline|Overall Study Population|All patients participating in the crossover study
153314|NCT01551888|P2|Participant Flow|Sequence 2|Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day
153315|NCT01551888|P1|Participant Flow|Sequence 1|Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day
153316|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
153317|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
153318|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
153319|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
153320|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
153321|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
153322|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
153323|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
153324|NCT01551888|E2|Reported Event|Formoterol 12 μg|Administered via Foradil® Aerolizer®
153325|NCT01551888|E1|Reported Event|Aclidinium/Formoterol 400/12 μg|Fixed dose combination (FDC) administered via Almirall inhaler
153326|NCT01551758|B3|Baseline|Total|Total of all reporting groups
153327|NCT01551758|B2|Baseline|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153328|NCT01551758|B1|Baseline|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153329|NCT01551758|P2|Participant Flow|Fluticasone Furoate (FF)/Vilanterol (VI) 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153330|NCT01551758|P1|Participant Flow|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153331|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153398|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
153332|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153333|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153334|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153335|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153336|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153337|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153338|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153339|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153340|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153341|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153342|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153343|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153344|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153345|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153346|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153347|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153348|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153349|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153350|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153351|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
188182|NCT01421498|O2|Outcome|Placebo|
153352|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153353|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153354|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153355|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|ExParticipants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153356|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153357|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153358|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153359|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153360|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153361|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153362|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153363|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|"Existing Maintenance Therapy:
Long acting bronchodilator therapy alone
ICS alone or in combination with a long acting bronchodilator
Triple maintenance therapy"
153364|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153365|NCT01551758|E2|Reported Event|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
153366|NCT01551758|E1|Reported Event|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
153367|NCT01551693|B3|Baseline|Total|Total of all reporting groups
153368|NCT01551693|B2|Baseline|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153369|NCT01551693|B1|Baseline|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153370|NCT01551693|P2|Participant Flow|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153371|NCT01551693|P1|Participant Flow|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153399|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
154307|NCT01545765|O2|Outcome|Lidocaine 7% + Tetracaine 7% Face - Second Application Time|
153372|NCT01551693|O2|Outcome|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153373|NCT01551693|O1|Outcome|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153374|NCT01551693|O2|Outcome|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153375|NCT01551693|O1|Outcome|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153376|NCT01551693|O2|Outcome|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153377|NCT01551693|O1|Outcome|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153378|NCT01551693|E2|Reported Event|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153379|NCT01551693|E1|Reported Event|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
153380|NCT01551355|B7|Baseline|Total|Total of all reporting groups
153381|NCT01551355|B6|Baseline|Usual Curriculum - Teachers|Control preschool facilities continued with their usual preschool curriculum
153382|NCT01551355|B5|Baseline|Healthy Habits Intervention - Teachers|Teachers participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received teacher’s guide.
153383|NCT01551355|B4|Baseline|Usual Curriculum - Parents/Caregivers|Control preschool facilities continued with their usual preschool curriculum
153384|NCT01551355|B3|Baseline|Healthy Habits Intervention - Parents/Caregivers|Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children.
153385|NCT01551355|B2|Baseline|Usual Curriculum - Children|Control preschool facilities continued with their usual preschool curriculum
153386|NCT01551355|B1|Baseline|Healthy Habits Intervention - Children|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
153387|NCT01551355|P6|Participant Flow|Usual Curriculum - Teachers|Control preschool facilities continued with their usual preschool curriculum
153388|NCT01551355|P5|Participant Flow|Healthy Habits Intervention - Teachers|Teachers participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received teacher's guide.
153389|NCT01551355|P4|Participant Flow|Usual Curriculum - Parents/Caregivers|Control preschool facilities continued with their usual preschool curriculum
153390|NCT01551355|P3|Participant Flow|Healthy Habits Intervention - Parents/Caregivers|Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children.
153391|NCT01551355|P2|Participant Flow|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
153392|NCT01551355|P1|Participant Flow|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
153393|NCT01551355|O2|Outcome|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
153394|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
153395|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
153396|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
153397|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
153496|NCT01550705|B1|Baseline|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.
Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
153400|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
154354|NCT01545700|O3|Outcome|Dexamethasone 8 mg 0-4 Hours|
153402|NCT01551355|E1|Reported Event|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
153403|NCT01551303|B3|Baseline|Total|Total of all reporting groups
153404|NCT01551303|B2|Baseline|Placebo|Placebo, 0.77 ml, intranasal
153405|NCT01551303|B1|Baseline|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
153406|NCT01551303|P2|Participant Flow|Placebo|Placebo, 0.77 ml, intranasal
153407|NCT01551303|P1|Participant Flow|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
153408|NCT01551303|O2|Outcome|Placebo|Placebo, 0.77 ml, intranasal
153409|NCT01551303|O1|Outcome|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
153410|NCT01551303|E2|Reported Event|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.
Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
153411|NCT01551303|E1|Reported Event|Placebo|"Matched nasal spray placebo.
Placebo: Matched nasal spray placebo"
153412|NCT01551199|B1|Baseline|Multiple Channel Exposure Therapy (MCET)|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks
Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
153413|NCT01551199|P1|Participant Flow|Multiple Channel Exosure Therapy (MCET-V)|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks
Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
153414|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
153415|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
153416|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
153417|NCT01551199|E1|Reported Event|Arm 1|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks
Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
153418|NCT01551173|B3|Baseline|Total|Total of all reporting groups
153419|NCT01551173|B2|Baseline|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
153420|NCT01551173|B1|Baseline|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
153421|NCT01551173|P2|Participant Flow|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
153422|NCT01551173|P1|Participant Flow|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
153423|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
153424|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
153425|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
153426|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
153427|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
153428|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
153429|NCT01551173|E3|Reported Event|Total|
153430|NCT01551173|E2|Reported Event|LescolIR (Fluvastatin Sodium Immediate Release Capsule)|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
153431|NCT01551173|E1|Reported Event|LescolXL (Fluvastatin Sodium Extended Release Tablet)|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
153432|NCT01551095|B1|Baseline|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEGJ tube: The self-propelled PEGJ feeding tube"
153433|NCT01551095|P1|Participant Flow|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEGJ tube: The self-propelled PEGJ feeding tube"
153434|NCT01551095|O1|Outcome|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEGJ tube: The self-propelled PEGJ feeding tube"
153435|NCT01551095|O1|Outcome|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEGJ tube: The self-propelled PEGJ feeding tube"
153436|NCT01551095|E1|Reported Event|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.
PEGJ tube: The self-propelled PEGJ feeding tube"
153437|NCT01551082|B1|Baseline|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
153438|NCT01551082|P1|Participant Flow|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
153439|NCT01551082|O1|Outcome|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
153578|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
188183|NCT01421498|O1|Outcome|Lifitegrast 5.0%|
153440|NCT01551082|E1|Reported Event|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
153498|NCT01550705|O1|Outcome|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.
Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
153441|NCT01550965|B1|Baseline|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153442|NCT01550965|P1|Participant Flow|Participants Receiving Adalimumab|Adults with active ulcerative colitis (UC) who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153443|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153444|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153445|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153446|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|"Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
Adalimumab: Adalimumab pre-filled syringe, administered by subcutaneous injection"
153447|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153448|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153449|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153450|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153451|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153452|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153453|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153454|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153455|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153456|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153457|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153579|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
153499|NCT01550705|O1|Outcome|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.
Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
154355|NCT01545700|O2|Outcome|Dexamethasone 4 mg 0-4 Hours|
153458|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153459|NCT01550965|E1|Reported Event|PARTICIPANTS RECEIVING ADALIMUMAB|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
153460|NCT01550952|B1|Baseline|Total Shoulder Arthroplasty Patients|
153461|NCT01550952|P1|Participant Flow|Total Shoulder Arthroplasty Patients|
153462|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
153463|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
153464|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
153465|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
153466|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
153467|NCT01550952|E1|Reported Event|Total Shoulder Arthroplasty Patients|
153468|NCT01550809|B3|Baseline|Total|Total of all reporting groups
153469|NCT01550809|B2|Baseline|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
153470|NCT01550809|B1|Baseline|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
153471|NCT01550809|P2|Participant Flow|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
153472|NCT01550809|P1|Participant Flow|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
153473|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
153474|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
153475|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
153476|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
153477|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
153478|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
153479|NCT01550809|E2|Reported Event|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
153480|NCT01550809|E1|Reported Event|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
153481|NCT01550744|B1|Baseline|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
153497|NCT01550705|P1|Participant Flow|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.
Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
154308|NCT01545765|O1|Outcome|Lidocaine 7% + Tetracaine 7% Face - First Application Time|
153482|NCT01550744|P3|Participant Flow|Group 2: Subject-tailored Fixed-interval Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
153483|NCT01550744|P2|Participant Flow|Group 1: Approved q12w Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
153484|NCT01550744|P1|Participant Flow|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
153485|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
153486|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
153487|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
153488|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
153489|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
153490|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
153491|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
153492|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
153493|NCT01550744|E3|Reported Event|Group 2: Subject-tailored Fixed-interval Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
153494|NCT01550744|E2|Reported Event|Group 1: Approved q12w Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
153495|NCT01550744|E1|Reported Event|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
153568|NCT01549977|B2|Baseline|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
154309|NCT01545765|O4|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time|
153500|NCT01550705|E1|Reported Event|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.
Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
153501|NCT01550549|B1|Baseline|Florbetapir-PET Scans|All subjects with a valid florbetapir-PET scan (59 from study A07/A16 and 92 from study A05)
153502|NCT01550549|P1|Participant Flow|Florbetapir-PET Scans|All subject scans with a valid florbetapir-PET scan
153503|NCT01550549|O1|Outcome|Autopsy Within One Year of Scan|Group of subjects with valid images who came to autopsy within 1 year of scan
153504|NCT01550549|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 year of scan
153505|NCT01550549|O1|Outcome|All Autopsy Population|
153506|NCT01550549|O1|Outcome|All Florbetapir-PET Scans|All subjects with a valid florbetapir-PET scan
153507|NCT01550549|O2|Outcome|Autopsy Within One Year of Scan|Subjects with a valid florbetapir-PET scan and autopsy (only those who deceased less than 12 months after the scan)
153508|NCT01550549|O1|Outcome|All Autopsy|Subjects with a valid florbetapir-PET scan and autopsy (including those who deceased more than 12 months after the scan)
153509|NCT01550549|O2|Outcome|Autopsy Within One Year of Scan|Subjects with a valid florbetapir-PET scan and autopsy (only those who deceased less than 12 months after the scan)
153510|NCT01550549|O1|Outcome|All Autopsy|Subjects with a valid florbetapir-PET scan and autopsy (including those who deceased more than 12 months after the scan)
153511|NCT01550549|O1|Outcome|Florbetapir-PET Scans Primary Analysis Group|
153512|NCT01550549|E1|Reported Event|Florbetapir-PET Scans|All subject scans with a valid florbetapir-PET scan
153513|NCT01550302|B3|Baseline|Total|Total of all reporting groups
153514|NCT01550302|B2|Baseline|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.
Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
153515|NCT01550302|B1|Baseline|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
153516|NCT01550302|P2|Participant Flow|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.
Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
153517|NCT01550302|P1|Participant Flow|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
153518|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.
Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
153519|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
153569|NCT01549977|B1|Baseline|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
153570|NCT01549977|P2|Participant Flow|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
153571|NCT01549977|P1|Participant Flow|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
153572|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
153573|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
153580|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
153581|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
153582|NCT01549977|E2|Reported Event|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
153583|NCT01549977|E1|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
153520|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.
Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
153521|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
153522|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.
Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
153523|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
153524|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.
Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
153525|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
153526|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.
Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
153527|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
153528|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.
Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
153529|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
153574|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
153575|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
153576|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
153577|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
153530|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.
Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
153531|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
153532|NCT01550302|E2|Reported Event|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.
Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
153533|NCT01550302|E1|Reported Event|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
153534|NCT01550289|B3|Baseline|Total|Total of all reporting groups
153535|NCT01550289|B2|Baseline|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153536|NCT01550289|B1|Baseline|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153537|NCT01550289|P2|Participant Flow|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153538|NCT01550289|P1|Participant Flow|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153539|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
153540|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
153541|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153542|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153543|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
153544|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
153545|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
153546|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
153547|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153548|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153549|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153550|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153551|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153552|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153553|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153554|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153555|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153556|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153557|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153558|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153559|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153560|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153561|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153562|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153563|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153564|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153565|NCT01550289|E2|Reported Event|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
153566|NCT01550289|E1|Reported Event|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
153567|NCT01549977|B3|Baseline|Total|Total of all reporting groups
153585|NCT01549964|B4|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153586|NCT01549964|B3|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153587|NCT01549964|B2|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153588|NCT01549964|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153589|NCT01549964|P4|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153590|NCT01549964|P3|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153591|NCT01549964|P2|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153592|NCT01549964|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153593|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153594|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153595|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153596|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153597|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153598|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153618|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
188184|NCT01421498|E2|Reported Event|Placebo|
153599|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153900|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153600|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153601|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153602|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153603|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153604|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153605|NCT01549964|E4|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153606|NCT01549964|E3|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153607|NCT01549964|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153608|NCT01549964|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
153609|NCT01549951|B1|Baseline|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153610|NCT01549951|P1|Participant Flow|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153611|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153612|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153613|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153614|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153615|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153616|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153617|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153619|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153901|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153620|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153621|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153622|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153623|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153624|NCT01549951|E1|Reported Event|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
153625|NCT01549925|B3|Baseline|Total|Total of all reporting groups
153626|NCT01549925|B2|Baseline|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
153627|NCT01549925|B1|Baseline|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures
Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
153628|NCT01549925|P2|Participant Flow|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
153629|NCT01549925|P1|Participant Flow|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures
Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
153630|NCT01549925|O2|Outcome|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
153631|NCT01549925|O1|Outcome|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures
Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
153632|NCT01549925|E2|Reported Event|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
153633|NCT01549925|E1|Reported Event|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures
Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
153634|NCT01549873|B3|Baseline|Total|Total of all reporting groups
153635|NCT01549873|B2|Baseline|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
153636|NCT01549873|B1|Baseline|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
153637|NCT01549873|P2|Participant Flow|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
153638|NCT01549873|P1|Participant Flow|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
153639|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
153640|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
153641|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
153642|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
153643|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
153644|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
153645|NCT01549873|E2|Reported Event|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
153646|NCT01549873|E1|Reported Event|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
153647|NCT01549860|B3|Baseline|Total|Total of all reporting groups
153648|NCT01549860|B2|Baseline|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy"
153649|NCT01549860|B1|Baseline|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
153650|NCT01549860|P2|Participant Flow|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy"
153651|NCT01549860|P1|Participant Flow|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
153652|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy"
153653|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
154021|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
153654|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy"
153655|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
153656|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy"
153657|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
153658|NCT01549860|E2|Reported Event|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy"
153659|NCT01549860|E1|Reported Event|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
153660|NCT01549613|B3|Baseline|Total|Total of all reporting groups
153661|NCT01549613|B2|Baseline|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
153662|NCT01549613|B1|Baseline|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol
Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
153663|NCT01549613|P2|Participant Flow|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
153664|NCT01549613|P1|Participant Flow|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol
Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
153665|NCT01549613|O2|Outcome|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
153666|NCT01549613|O1|Outcome|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol
Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
153667|NCT01549613|E2|Reported Event|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
153668|NCT01549613|E1|Reported Event|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol
Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
153669|NCT01549405|B3|Baseline|Total|Total of all reporting groups
153670|NCT01549405|B2|Baseline|Nerve Block|"Group that performing intercostal block
İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
153671|NCT01549405|B1|Baseline|Control Group|Control group: Group that without intercostal nerve block
153672|NCT01549405|P2|Participant Flow|Nerve Block|"Group that performing intercostal block
İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
153673|NCT01549405|P1|Participant Flow|Control Group|Control group: Group that without intercostal nerve block
153674|NCT01549405|O2|Outcome|Nerve Block|"Group that performing intercostal block
İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
153675|NCT01549405|O1|Outcome|Control Group|Control group: Group that without intercostal nerve block
153676|NCT01549405|O2|Outcome|İntercostal Nerve Block|Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
153677|NCT01549405|O1|Outcome|Control|Group that without intercostal nerve block
153678|NCT01549405|E2|Reported Event|İntercostal Nerve Block|Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
153679|NCT01549405|E1|Reported Event|Control|Group that without intercostal nerve block
153680|NCT01549392|B3|Baseline|Total|Total of all reporting groups
153681|NCT01549392|B2|Baseline|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
153682|NCT01549392|B1|Baseline|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
153773|NCT01548742|E1|Reported Event|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
153683|NCT01549392|P2|Participant Flow|DECT/MRS in Glioma Patients Not Receiving Avastin|"0 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
153684|NCT01549392|P1|Participant Flow|DECT/MRS in Patients Receiving Avastin|"3 Glioma Patients underwent DECT and MRS pre-Avastin and 3 months later after receiving avastin 10 mg/kg iv q2weeks
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later Avastin 10 mg/kg iv q2weeks"
153685|NCT01549392|O2|Outcome|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
153686|NCT01549392|O1|Outcome|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
153687|NCT01549392|E2|Reported Event|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
153688|NCT01549392|E1|Reported Event|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
153689|NCT01549340|B1|Baseline|Participants With AR|Participants with AR whose records were retrospectively reviewed
153690|NCT01549340|P1|Participant Flow|Participants With AR|Participants with AR whose records were retrospectively reviewed
153691|NCT01549340|O2|Outcome|Participants With AR Alone|Participants with AR alone who elected AIT and whose records were retrospectively reviewed
153692|NCT01549340|O1|Outcome|Participants With AR and Asthma|Participants with AR and asthma who elected AIT and whose records were retrospectively reviewed
153693|NCT01549340|O1|Outcome|Participants With AR and Asthma|Participants with AR and asthma whose records were retrospectively reviewed
153694|NCT01549340|O2|Outcome|Participants With AR Who Discontinued SLIT|Participants with AR whose records were retrospectively reviewed and discontinued SLIT
153695|NCT01549340|O1|Outcome|Participants With AR Who Discontinued SCIT|Participants with AR whose records were retrospectively reviewed and discontinued SCIT
153696|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
153697|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
153698|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
153699|NCT01549340|E1|Reported Event|Participants With AR|Participants with AR whose records were retrospectively reviewed
153700|NCT01549275|B3|Baseline|Total|Total of all reporting groups
153701|NCT01549275|B2|Baseline|AJCC TNM Staging > = IIIB HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
153702|NCT01549275|B1|Baseline|AJCC TNM Staging < = IIIA HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
153703|NCT01549275|P2|Participant Flow|AJCC TNM Staging > = IIIB HCC Patients|29 patients belonged to AJCC TNM staging > = IIIB.
153704|NCT01549275|P1|Participant Flow|AJCC TNM Staging < = IIIA HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition). 76 patients with JACC TNM staging < = IIIA.
153705|NCT01549275|O5|Outcome|TNM Staging > = IIIB Patients Receiving Supportive Treatment|All patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree C or D.
153706|NCT01549275|O4|Outcome|TNM Staging > = IIIB Patients Receiving TACE|All patients belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree C.
153707|NCT01549275|O3|Outcome|TNM Staging < = IIIA Patients Receiving Supportive Treatment|5 patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree B and the other 4 patients belonged to BCLC degree C or D.
153708|NCT01549275|O2|Outcome|TNM Staging < = IIIA Patients Receiving TACE|All patients belonged to Child A classification and BCLC(Barcelona Clinic Liver Cancer classification) degree A or B.
153709|NCT01549275|O1|Outcome|TNM Staging < = IIIA Patients Receiving Curative Treatment|All patient belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree A (14 patients) or B (8 patients).
153710|NCT01549275|O2|Outcome|AJCC TNM Staging < = IIIA HCC Patients|
153711|NCT01549275|O1|Outcome|AJCC TNM Staging > = IIIB|
153712|NCT01549275|E1|Reported Event|HCC Patients Underwent FNA of Tumor|Patients who had residual specimens obtained from ultrasound-guided fine-needle aspiration of hepatic tumor measuring equal or larger than 3cm were included. The residual specimens were applied for primary culture and no additional aspiration of the tumor was performed solely for the collection of specimens for culture. Serious and other Adverse Events were not collected/assessed.
153713|NCT01549223|B3|Baseline|Total|Total of all reporting groups
153714|NCT01549223|B2|Baseline|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM.
If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
153772|NCT01548742|E2|Reported Event|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
153897|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153715|NCT01549223|B1|Baseline|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
153716|NCT01549223|P2|Participant Flow|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM (Intramuscular).
If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
153717|NCT01549223|P1|Participant Flow|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM (Intramuscular) or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
153718|NCT01549223|O2|Outcome|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM.
If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
153719|NCT01549223|O1|Outcome|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
153720|NCT01549223|O2|Outcome|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM.
If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
153721|NCT01549223|O1|Outcome|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
153722|NCT01549223|E2|Reported Event|Protocol Group|"Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM.
If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale)."
153742|NCT01549002|E2|Reported Event|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.
The abscess I&D will be followed according to protocol using topical and local anesthetic.
Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
154310|NCT01545765|O3|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - First Application Time|
153723|NCT01549223|E1|Reported Event|Standard Care Group|"Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request."
153724|NCT01549041|B3|Baseline|Total|Total of all reporting groups
153725|NCT01549041|B2|Baseline|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening
Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
153726|NCT01549041|B1|Baseline|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening
Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
153727|NCT01549041|P2|Participant Flow|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening
Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
153728|NCT01549041|P1|Participant Flow|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening
Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
153729|NCT01549041|O2|Outcome|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening
Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
153730|NCT01549041|O1|Outcome|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening
Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
153731|NCT01549041|O2|Outcome|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening
Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
153732|NCT01549041|O1|Outcome|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening
Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
153733|NCT01549041|E2|Reported Event|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening
Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
153734|NCT01549041|E1|Reported Event|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening
Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
153735|NCT01549002|B3|Baseline|Total|Total of all reporting groups
153736|NCT01549002|B2|Baseline|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.
The abscess I&D will be followed according to protocol using topical and local anesthetic.
Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
153737|NCT01549002|B1|Baseline|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).
The abscess I&D will be followed according to protocol using topical and local anesthetic.
Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
153738|NCT01549002|P2|Participant Flow|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.
The abscess I&D will be followed according to protocol using topical and local anesthetic.
Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
153739|NCT01549002|P1|Participant Flow|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).
The abscess I&D will be followed according to protocol using topical and local anesthetic.
Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
153740|NCT01549002|O2|Outcome|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.
The abscess I&D will be followed according to protocol using topical and local anesthetic.
Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
153741|NCT01549002|O1|Outcome|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).
The abscess I&D will be followed according to protocol using topical and local anesthetic.
Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
153898|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153743|NCT01549002|E1|Reported Event|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).
The abscess I&D will be followed according to protocol using topical and local anesthetic.
Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
153744|NCT01548885|B1|Baseline|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
153745|NCT01548885|P1|Participant Flow|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
153746|NCT01548885|O1|Outcome|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
153747|NCT01548885|O1|Outcome|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
153748|NCT01548885|E1|Reported Event|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
153749|NCT01548833|B1|Baseline|Overall|DT1, TruEye, and Clariti contact lenses worn in randomized, cross-over fashion for one week each
153750|NCT01548833|P1|Participant Flow|Overall|All enrolled participants
153751|NCT01548833|O3|Outcome|Clariti|Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
153752|NCT01548833|O2|Outcome|TruEye|Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
153753|NCT01548833|O1|Outcome|Dailies Total 1|Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
153754|NCT01548833|E3|Reported Event|Clariti|Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
153755|NCT01548833|E2|Reported Event|TruEye|Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
153756|NCT01548833|E1|Reported Event|Dailies Total 1|Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
153757|NCT01548742|B3|Baseline|Total|Total of all reporting groups
153758|NCT01548742|B2|Baseline|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
153759|NCT01548742|B1|Baseline|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
153760|NCT01548742|P2|Participant Flow|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
153761|NCT01548742|P1|Participant Flow|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
153762|NCT01548742|O2|Outcome|Arm 2: Present Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
153763|NCT01548742|O1|Outcome|Arm 1: Mindfulness Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
153764|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
153765|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
153766|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
153767|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
153768|NCT01548742|O2|Outcome|Arm 2: Present Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
153769|NCT01548742|O1|Outcome|Arm 1: Mindfulness Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
153770|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
153771|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
154077|NCT01546922|O2|Outcome|High Dose of Hydrocortisone|Results from the participants while receiving the high dose of hydrocortisone
153774|NCT01548638|B1|Baseline|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
153775|NCT01548638|P1|Participant Flow|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
153776|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
153777|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
153778|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
153779|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
153780|NCT01548638|E1|Reported Event|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
153781|NCT01548573|B1|Baseline|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
153782|NCT01548573|P1|Participant Flow|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
153783|NCT01548573|O1|Outcome|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
153784|NCT01548573|O1|Outcome|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
153785|NCT01548573|O1|Outcome|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
153839|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
153899|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
154356|NCT01545700|O1|Outcome|Placebo 0-4 Hours|Placebo 0-4 hours baseline
153786|NCT01548573|O1|Outcome|Tandem Autologous Stem Cell Transplant|"Induction and PBSC Collection:1 cycle of combination D-PACE (and peripheral blood stem cell collection. After collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days.
Transplant 1: 6 weeks after first day of D-PACE , but can occur as early as 4 weeks and as late as 6 months. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Transplant 2: 8 weeks-6 months after the first transplant, participants will have second transplant. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation Phase (if administered): 4 weeks-4 months after second transplant, participants may receive consolidation chemotherapy.
Maintenance Phase year 1 and 2:The first year of maintenance will commence between 6 weeks-6 months after consolidation or 4 weeks-6 months after transplant if consolidation is skipped.
DP"
153787|NCT01548573|E1|Reported Event|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
153788|NCT01548417|B3|Baseline|Total|Total of all reporting groups
153789|NCT01548417|B2|Baseline|Placebo|Sugar Pill: placebo, oral pill, 7 days
153790|NCT01548417|B1|Baseline|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
153791|NCT01548417|P2|Participant Flow|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
153792|NCT01548417|P1|Participant Flow|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
153793|NCT01548417|O2|Outcome|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
153794|NCT01548417|O1|Outcome|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
153795|NCT01548417|O2|Outcome|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
153796|NCT01548417|O1|Outcome|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
153797|NCT01548417|E2|Reported Event|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
153798|NCT01548417|E1|Reported Event|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
153799|NCT01548287|B5|Baseline|Total|Total of all reporting groups
153800|NCT01548287|B4|Baseline|Placebo|Placebo daily
153801|NCT01548287|B3|Baseline|AZD5213 Dose C|AZD5213 6.0 mg daily
153802|NCT01548287|B2|Baseline|AZD5213 Dose B|AZD 5213 2.0 mg daily
153803|NCT01548287|B1|Baseline|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
153804|NCT01548287|P5|Participant Flow|Screening Only|Screening period only, not randomized
153805|NCT01548287|P4|Participant Flow|Placebo|Placebo daily
153806|NCT01548287|P3|Participant Flow|AZD5213 Dose C|AZD5213 6.0 mg daily
153807|NCT01548287|P2|Participant Flow|AZD5213 Dose B|AZD 5213 2.0 mg daily
153808|NCT01548287|P1|Participant Flow|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
153809|NCT01548287|O4|Outcome|Placebo|Placebo daily
153810|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
153811|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
153812|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
153813|NCT01548287|O4|Outcome|Placebo|Placebo daily
153814|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
153815|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
153816|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
153817|NCT01548287|O4|Outcome|Placebo|Placebo daily
153818|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
153819|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
153820|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
153821|NCT01548287|O4|Outcome|Placebo|Placebo daily
153822|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
153823|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
153824|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
153825|NCT01548287|O4|Outcome|Placebo|Placebo daily
153826|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
153827|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
153828|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
153829|NCT01548287|O4|Outcome|Placebo|Placebo daily
153830|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
153831|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
153832|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
153833|NCT01548287|E4|Reported Event|Placebo|Placebo daily
153834|NCT01548287|E3|Reported Event|AZD5213 Dose C|AZD5213 6.0 mg daily
153835|NCT01548287|E2|Reported Event|AZD5213 Dose B|AZD 5213 2.0 mg daily
153836|NCT01548287|E1|Reported Event|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
153837|NCT01547806|B1|Baseline|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106^ CD34+ cells/kg."
153838|NCT01547806|P1|Participant Flow|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
153893|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153894|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153895|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153840|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
153841|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
153842|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
153843|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
153844|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
153845|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
153846|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
153847|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
153848|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
153849|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
153850|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
153851|NCT01547806|O1|Outcome|Hematopoietic Progenitor Cells (HPC)|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg."
153896|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
154311|NCT01545765|O2|Outcome|Lidocaine 7% + Tetracaine 7% Face - Second Application Time|
153852|NCT01547806|E1|Reported Event|Hematopoietic Progenitor Cells|"Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg."
153853|NCT01547728|B1|Baseline|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
153854|NCT01547728|P1|Participant Flow|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
153855|NCT01547728|O1|Outcome|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
153856|NCT01547728|E1|Reported Event|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
153857|NCT01547715|B4|Baseline|Total|Total of all reporting groups
153858|NCT01547715|B3|Baseline|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
153859|NCT01547715|B2|Baseline|11 - 18 Years|Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1
153860|NCT01547715|B1|Baseline|2 - 10 Years|Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1
153861|NCT01547715|P3|Participant Flow|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
153862|NCT01547715|P2|Participant Flow|11 - 18 Years|Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1.
153863|NCT01547715|P1|Participant Flow|2 - 10 Years|Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1.
153864|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153865|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153866|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153867|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153868|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153869|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153870|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153871|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153872|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153873|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153874|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153875|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153876|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153877|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153878|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153879|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153880|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153881|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153882|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153883|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153884|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153885|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153886|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153887|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153888|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153889|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153890|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153891|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153892|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
188185|NCT01421498|E1|Reported Event|Lifitegrast 5.0%|
153902|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153903|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153904|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153905|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153906|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153907|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153908|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153909|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153910|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153911|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153912|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153913|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153914|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153915|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153916|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153917|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153918|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153919|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153920|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153921|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153922|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153923|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153924|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153925|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153926|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153927|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153928|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153929|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153930|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153931|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153932|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153933|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153934|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153935|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153936|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153937|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153938|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153939|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153940|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153941|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153942|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153943|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153944|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
154312|NCT01545765|O1|Outcome|Lidocaine 7% + Tetracaine 7% Face - First Application Time|
153945|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153946|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153947|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153948|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153949|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153950|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153951|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153952|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153953|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153954|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153955|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153956|NCT01547715|E4|Reported Event|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153957|NCT01547715|E3|Reported Event|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1
153958|NCT01547715|E2|Reported Event|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153959|NCT01547715|E1|Reported Event|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
153960|NCT01547598|B3|Baseline|Total|Total of all reporting groups
153961|NCT01547598|B2|Baseline|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
153962|NCT01547598|B1|Baseline|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
153963|NCT01547598|P2|Participant Flow|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
153964|NCT01547598|P1|Participant Flow|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
153965|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
153966|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
153967|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
153968|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
153969|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
153970|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
153971|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
153972|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
153973|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
153974|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
153975|NCT01547598|E3|Reported Event|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
154313|NCT01545765|E1|Reported Event|Lidocaine 7% + Tetracaine 7%|
153976|NCT01547598|E2|Reported Event|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
154078|NCT01546922|O1|Outcome|Low Dose of Hydrocortisone|Results from the participants while receiving the low dose of hydrocortisone
153977|NCT01547598|E1|Reported Event|Travatan® Z|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks for all participants.
153978|NCT01547299|B3|Baseline|Total|Total of all reporting groups
153979|NCT01547299|B2|Baseline|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
153980|NCT01547299|B1|Baseline|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
153981|NCT01547299|P2|Participant Flow|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
153982|NCT01547299|P1|Participant Flow|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
153983|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
153984|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
153985|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
153986|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
153987|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
153988|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
153989|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
153990|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
153991|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
153992|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
153993|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
153994|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
153995|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
153996|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
153997|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
153998|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
153999|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154000|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154001|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154002|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154003|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154004|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154005|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154006|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154007|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154008|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154009|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154010|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154011|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154012|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154013|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154014|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154015|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154016|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154017|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154018|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154019|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154020|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
168898|NCT01485094|B4|Baseline|Total|Total of all reporting groups
154022|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154023|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154024|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154025|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154026|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154027|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154028|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154029|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154030|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154031|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154032|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154033|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154034|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154035|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154036|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154037|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154038|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154039|NCT01547299|E2|Reported Event|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
154040|NCT01547299|E1|Reported Event|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
154041|NCT01547286|B1|Baseline|Allergic Asthmatic|Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge. Nebulized methacholine inhalation: Standard
154042|NCT01547286|P1|Participant Flow|Allergic Asthmatic|This is a single physiological group study where each subject served as their own control. All eligible subjects underwent a methacholine challenge test, clinical assessment and skin tests to ascertain the diagnosis of allergic asthma. Both methacholine and skin test results were used to determine the start dose of the bronchial allergen challenge test. CT and PET with Nitrogen-13 (13NN) saline as a radiotracer images were obtained during the early and late phases after allergen challenge.
154043|NCT01547286|O1|Outcome|Allergic Asthmatic|"Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.
CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge Nebulized methacholine inhalation: Standard"
154044|NCT01547286|O1|Outcome|Allergic Asthmatic|"Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.
CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge Nebulized methacholine inhalation: Standard"
154076|NCT01546922|P1|Participant Flow|First a Low Dose of HC Followed by a High Dose of HC|First low dose of hydrocortisone = 0.2-0.3 mg/kg body weight for 10 weeks followed by a high dose of hydrocortisone = 0.4-0.6 mg/kg body weight
154314|NCT01545700|B7|Baseline|Total|Total of all reporting groups
154079|NCT01546922|E2|Reported Event|High Dose of HC|Administration of a high dose of hydrocortisone (0.4-0.6 mg/kg body weight) for 10 weeks
154080|NCT01546922|E1|Reported Event|Low Dose of HC|Administration of a low dose of hydrocortisone (0.2-0.3 mg/kg body weight) for 10 weeks
154045|NCT01547286|E1|Reported Event|Allergic Asthmatic|"Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.
CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge"
154046|NCT01547247|B3|Baseline|Total|Total of all reporting groups
154047|NCT01547247|B2|Baseline|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
154048|NCT01547247|B1|Baseline|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
154049|NCT01547247|P2|Participant Flow|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
154050|NCT01547247|P1|Participant Flow|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
154051|NCT01547247|O2|Outcome|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
154052|NCT01547247|O1|Outcome|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
154053|NCT01547247|O2|Outcome|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
154054|NCT01547247|O1|Outcome|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
154055|NCT01547247|E2|Reported Event|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
154056|NCT01547247|E1|Reported Event|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
154057|NCT01547130|B3|Baseline|Total|Total of all reporting groups
154058|NCT01547130|B2|Baseline|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
154059|NCT01547130|B1|Baseline|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
154060|NCT01547130|P2|Participant Flow|HalfLytely Colon Prep (HCP)|Patients followed the preparation method according to the manufacturer's standard instructions.
154061|NCT01547130|P1|Participant Flow|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
154062|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
154063|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
154064|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions. Subjects recorded adverse events.
154065|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Patients take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses. Adverse events were recorded on questionnaire.
154066|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Subjects rated the HCP as palatable
154067|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Subjects rated the SCC as palatable
154068|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Solution palatability of HCP by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.
154069|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Solution palatability of SCC by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.
154070|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients in the HCP group followed the preparation method according to the manufacturer's standard instructions. Patients were instructed to stay on clear liquids the entire day before the colonoscopy. Two tablets of bisacodyl delayed-release tablets with water were taken at around 1:00 pm. Patients were instructed to start drinking the solution after a bowel movement or around 7 pm if no bowel activity occurred. They were instructed to sip all of the solution at a rate of 8 oz. every 10 minutes.
154071|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Yoga contained a 32-oz plastic pitcher and 9-gm salt sachets (Iodine-free table salt - USP grade sodium chloride) for preparation of 0.9% saline (1 sachet in 32-oz lukewarm water (37.2-38.8 degrees Centigrade or 99-102 degrees Fahrenheit)), an instructional leaflet, and a DVD providing instructions of the bowel preparation process. Patients were instructed to fill the pitcher with 16-oz of hot water and 16-oz of room temperature water to reach the lukewarm temperature. Patients could add a twist of lemon if the solution was unpalatable to them.
154072|NCT01547130|E2|Reported Event|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
154073|NCT01547130|E1|Reported Event|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
154074|NCT01546922|B1|Baseline|All Participants|All participants completing both study periods
154075|NCT01546922|P2|Participant Flow|First a High Dose of HC Followed by a Low Dose of HC|First high dose of hydrocortisone = 0.4-0.6 mg/kg body weight for 10 weeks followed by a low dose of hydrocortisone = 0.2-0.3 mg/kg body weight
154082|NCT01546883|P1|Participant Flow|Dabigatran|"Patients with Atrial fibrillation taking Dabigatran etexilate as the anti-coagulant
Dabigatran etexilate (Pradaxa): 150mg bid or 75mg bid for a period of one year"
154083|NCT01546883|O1|Outcome|Dabigatran|Dabigatran
154084|NCT01546883|E1|Reported Event|Dabigatran|Patients taking Dabigatran
154085|NCT01546688|B3|Baseline|Total|Total of all reporting groups
154086|NCT01546688|B2|Baseline|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
154087|NCT01546688|B1|Baseline|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
154088|NCT01546688|P2|Participant Flow|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
154089|NCT01546688|P1|Participant Flow|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
154090|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
154091|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
154092|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
154093|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
154094|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
154095|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
154096|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
154097|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
154098|NCT01546688|E2|Reported Event|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
154099|NCT01546688|E1|Reported Event|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
154100|NCT01546675|B3|Baseline|Total|Total of all reporting groups
154101|NCT01546675|B2|Baseline|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design
154102|NCT01546675|B1|Baseline|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
154103|NCT01546675|P2|Participant Flow|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
154104|NCT01546675|P1|Participant Flow|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
154105|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
188186|NCT01421472|B5|Baseline|Total|Total of all reporting groups
154106|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
154107|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
154108|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
154109|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
154110|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
154111|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
154112|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
154113|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
154114|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|.Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
154115|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
154116|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
154117|NCT01546675|E1|Reported Event|Cases|Subjects using the Traditional Socket and socket hypothesized to increase skeletal stabilization in a case cross-over design.
154118|NCT01546649|B3|Baseline|Total|Total of all reporting groups
154119|NCT01546649|B2|Baseline|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154120|NCT01546649|B1|Baseline|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154121|NCT01546649|P2|Participant Flow|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154122|NCT01546649|P1|Participant Flow|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154123|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154124|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154125|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154126|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154127|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154128|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154129|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154130|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154131|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154132|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154133|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154134|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154135|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154136|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154137|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154138|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
191293|NCT01405794|O2|Outcome|32ppm Oral Silver|
154139|NCT01546649|E2|Reported Event|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154140|NCT01546649|E1|Reported Event|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
154141|NCT01546636|B3|Baseline|Total|Total of all reporting groups
154145|NCT01546636|P1|Participant Flow|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
154146|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
154147|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
154148|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
154149|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
154150|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
154151|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
154152|NCT01546636|E2|Reported Event|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
154153|NCT01546636|E1|Reported Event|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
154154|NCT01546623|B3|Baseline|Total|Total of all reporting groups
154155|NCT01546623|B2|Baseline|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154156|NCT01546623|B1|Baseline|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154157|NCT01546623|P2|Participant Flow|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154158|NCT01546623|P1|Participant Flow|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154159|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154160|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154161|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154162|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154163|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154164|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154165|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154166|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154167|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154168|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154169|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154170|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154171|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154172|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154173|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154174|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154175|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154176|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154177|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154178|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154179|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154180|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154181|NCT01546623|E2|Reported Event|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
154182|NCT01546623|E1|Reported Event|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
154183|NCT01546519|B5|Baseline|Total|Total of all reporting groups
154184|NCT01546519|B4|Baseline|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154185|NCT01546519|B3|Baseline|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154734|NCT01544348|O6|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
154186|NCT01546519|B2|Baseline|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154270|NCT01546155|O1|Outcome|Healthy Controls|PET imaging: Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
154271|NCT01546155|E1|Reported Event|Healthy Volunteers|PET imaging: Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
154187|NCT01546519|B1|Baseline|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.
Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154188|NCT01546519|P4|Participant Flow|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154189|NCT01546519|P3|Participant Flow|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154190|NCT01546519|P2|Participant Flow|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154191|NCT01546519|P1|Participant Flow|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
154192|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154193|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154194|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154195|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
154196|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154197|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154315|NCT01545700|B6|Baseline|Dexamethasone 8 mg, 8-24 Hours|"Dexamethasone 8 mg administered intraoperatively
Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg"
154316|NCT01545700|B5|Baseline|Dexamethasone 4 mg, 8-24 Hours|"Dexamethasone 4 mg administered intraoperatively
Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc"
191294|NCT01405794|O1|Outcome|Placebo|
154198|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154199|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
154200|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154201|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154202|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154203|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
154204|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154205|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154206|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154207|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
154208|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154209|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154317|NCT01545700|B4|Baseline|Placebo Comparator Saline 8-24 Hours|"placebo, 2 cc saline
Control saline : Patients are randomized to receive saline 2 cc"
154318|NCT01545700|B3|Baseline|Dexamethasone 8 mg, 0-4 Hours|"Dexamethasone 8 mg administered intraoperatively
Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg"
154735|NCT01544348|O5|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
154210|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154211|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.
Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154212|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154213|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154214|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154215|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.
Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154216|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154217|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154218|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154219|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.
Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154220|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154221|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154319|NCT01545700|B2|Baseline|Dexamethasone 4 mg, 0-4 Hours|"Dexamethasone 4 mg administered intraoperatively
Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline"
154320|NCT01545700|B1|Baseline|Control, Saline 0-4 Hours|"2 cc of saline
Control-saline : Patients are randomized to receive saline 2 cc"
154736|NCT01544348|O4|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
154222|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154223|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.
Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154224|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154225|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154226|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154227|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.
Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154228|NCT01546519|E4|Reported Event|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.
Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154229|NCT01546519|E3|Reported Event|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.
Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154230|NCT01546519|E2|Reported Event|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.
Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154231|NCT01546519|E1|Reported Event|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.
Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
154232|NCT01546454|B1|Baseline|All Study Participants|
154233|NCT01546454|P1|Participant Flow|All Study Participants|
154234|NCT01546454|O3|Outcome|Steroid Effects|"Estrogen/Progesterone replacement cycle versus Eligard treatment. Interventions include leuprolide acetate, estradiol, and progesterone.
leuprolide acetate: single 22.5 mg subcutaneous depot suspension
Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days
Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days"
154235|NCT01546454|O2|Outcome|Contraceptive Effects|"Oral contraceptive cycle versus Eligard treatment. Interventions include ethinyl estradiol-levonorgestrel combination and leuprolide acetate.
Ethinyl Estradiol-Levonorgestrel combination: 0.03 mg ethinyl estradiol, 0.15 mg levonorgestrel oral daily for 21 days
leuprolide acetate: single 22.5 mg subcutaneous depot suspension"
154236|NCT01546454|O1|Outcome|Non-steroidal Effects|"Natural menstrual cycle versus Estrogen/Progesterone replacement cycle. Interventions include leuprolide acetate to induce hypogonadism and estradiol and progesterone to replace hormone levels.
leuprolide acetate: single 22.5 mg subcutaneous depot suspension
Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days
Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days"
154237|NCT01546454|E1|Reported Event|All Study Participants|
154238|NCT01546402|B3|Baseline|Total|Total of all reporting groups
154269|NCT01546155|P1|Participant Flow|Healthy Volunteers|The PET/fMRI scan session will last up to 120 minutes. Subjects will have 2 MR-PET scan sessions, each lasting up to 120 minutes, with a break between scan sessions. Approximately nine venous blood samples will be taken per scan session with a maximum of 48mL of blood drawn per scan session. Intermittent cuff pain, based on the previously determined Strong ratings, will be applied during one of the two scan sessions. Subjects will rate the pain they feel as a result of the cuff stimuli using the Gracely scale.
154239|NCT01546402|B2|Baseline|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
154240|NCT01546402|B1|Baseline|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
154241|NCT01546402|P2|Participant Flow|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
154242|NCT01546402|P1|Participant Flow|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
154243|NCT01546402|O2|Outcome|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
154244|NCT01546402|O1|Outcome|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
154245|NCT01546402|O2|Outcome|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
154268|NCT01546155|B1|Baseline|Healthy Volunteers|The PET/fMRI scan session will last up to 120 minutes. Subjects will have 2 MR-PET scan sessions, each lasting up to 120 minutes, with a break between scan sessions. Approximately nine venous blood samples will be taken per scan session with a maximum of 48mL of blood drawn per scan session. Intermittent cuff pain, based on the previously determined Strong ratings, will be applied during one of the two scan sessions. Subjects will rate the pain they feel as a result of the cuff stimuli using the Gracely scale. The additional scan session for subjects will be performed under no pain, “control” conditions.
154321|NCT01545700|P6|Participant Flow|Dexamethasone 8 mg, 8-24 Hours|"Dexamethasone 8 mg administered intraoperatively
Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg"
154246|NCT01546402|O1|Outcome|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
154247|NCT01546402|E2|Reported Event|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
154248|NCT01546402|E1|Reported Event|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
154249|NCT01546285|B1|Baseline|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
154250|NCT01546285|P1|Participant Flow|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
154251|NCT01546285|O3|Outcome|B40 and PRO1000 - MAP|
154252|NCT01546285|O2|Outcome|B40 and PRO1000 - Diastolic BP|
154253|NCT01546285|O1|Outcome|B40 and PRO1000 - Systolic BP|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
154254|NCT01546285|E1|Reported Event|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
154255|NCT01546207|B1|Baseline|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
154256|NCT01546207|P1|Participant Flow|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
154257|NCT01546207|O1|Outcome|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
154258|NCT01546207|E1|Reported Event|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
154259|NCT01546194|B3|Baseline|Total|Total of all reporting groups
154260|NCT01546194|B2|Baseline|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project
Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
154261|NCT01546194|B1|Baseline|Morning Consent|"Consent process consisting of information only provided on the morning of surgery
Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
154262|NCT01546194|P2|Participant Flow|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project
Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
154263|NCT01546194|P1|Participant Flow|Morning Consent|Consent process consisting of information only provided on the morning of surgery
154264|NCT01546194|O2|Outcome|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project
Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
154265|NCT01546194|O1|Outcome|Morning Consent|Consent process consisting of information only provided on the morning of surgery
154266|NCT01546194|E2|Reported Event|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project
Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
154267|NCT01546194|E1|Reported Event|Morning Consent|Consent process consisting of information only provided on the morning of surgery
154301|NCT01545843|E2|Reported Event|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, two hour delay of bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154302|NCT01545843|E1|Reported Event|No Sleep Deprivation|"8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for two weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154273|NCT01546142|B2|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154274|NCT01546142|B1|Baseline|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154275|NCT01546142|P2|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154276|NCT01546142|P1|Participant Flow|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154277|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154278|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154279|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154280|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154281|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154282|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154283|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154284|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154285|NCT01546142|E2|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154286|NCT01546142|E1|Reported Event|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
154287|NCT01545843|B4|Baseline|Total|Total of all reporting groups
154288|NCT01545843|B3|Baseline|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication
Sleep scheduling:6 hours time in bed for two weeks; risetime advanced by 2 hours
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154289|NCT01545843|B2|Baseline|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication
Sleep scheduling:6 hours time in bed for two weeks; bedtime delayed by 2 hours
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154290|NCT01545843|B1|Baseline|No Sleep Deprivation|"8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for two weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154291|NCT01545843|P3|Participant Flow|Early Risetime Sleep Deprivation|6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
154292|NCT01545843|P2|Participant Flow|Late Bedtime Sleep Deprivation|6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
154293|NCT01545843|P1|Participant Flow|No Sleep Deprivation|8 hours time in bed for two weeks plus fluoxetine for 8 weeks
154294|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154295|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154296|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication
Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154297|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154298|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154299|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for 2 weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154300|NCT01545843|E3|Reported Event|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, two hour advance of risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
154303|NCT01545765|B1|Baseline|Lidocaine 7% and Tetracaine 7%|
154304|NCT01545765|P1|Participant Flow|Face 2 Application Times/ Thight 2 Application Times|
154322|NCT01545700|P5|Participant Flow|Dexamethasone 4 mg, 8-24 Hours|"Dexamethasone 4 mg administered intraoperatively
Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc"
154323|NCT01545700|P4|Participant Flow|Placebo Comparator Saline 8-24 Hours|"placebo, 2 cc saline
Control saline : Patients are randomized to receive saline 2 cc"
154324|NCT01545700|P3|Participant Flow|Dexamethasone 8 mg, 0-4 Hours|"Dexamethasone 8 mg administered intraoperatively
Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg"
154325|NCT01545700|P2|Participant Flow|Dexamethasone 4 mg, 0-4 Hours|"Dexamethasone 4 mg administered intraoperatively
Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline"
154326|NCT01545700|P1|Participant Flow|Control, Saline 0-4 Hours|"2 cc of saline
Control-saline : Patients are randomized to receive saline 2 cc"
154357|NCT01545700|E2|Reported Event|Dexamethasone Group|either 4 mg or 8 mg
154358|NCT01545700|E1|Reported Event|Control-saline Group|
154359|NCT01545518|B1|Baseline|All Subjects|"IVIG
IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
154360|NCT01545518|P1|Participant Flow|All Subjects|"IVIG
IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
154361|NCT01545518|O1|Outcome|All Subjects|"IVIG
IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
154362|NCT01545518|E1|Reported Event|All Subjects|"IVIG
IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover
No AE's."
154363|NCT01545388|B4|Baseline|Total|Total of all reporting groups
154364|NCT01545388|B3|Baseline|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
154365|NCT01545388|B2|Baseline|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
154366|NCT01545388|B1|Baseline|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
154367|NCT01545388|P3|Participant Flow|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
154368|NCT01545388|P2|Participant Flow|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
154369|NCT01545388|P1|Participant Flow|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
154370|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
154371|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
154372|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
154373|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
154374|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
154375|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
154376|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
154538|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154377|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
154378|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
154379|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
154380|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
154381|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
154382|NCT01545388|E3|Reported Event|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
154383|NCT01545388|E2|Reported Event|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
154384|NCT01545388|E1|Reported Event|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
154385|NCT01545336|B3|Baseline|Total|Total of all reporting groups
154386|NCT01545336|B2|Baseline|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
154387|NCT01545336|B1|Baseline|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
154388|NCT01545336|P2|Participant Flow|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
154389|NCT01545336|P1|Participant Flow|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
154390|NCT01545336|O2|Outcome|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
154391|NCT01545336|O1|Outcome|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
154392|NCT01545336|O2|Outcome|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
154393|NCT01545336|O1|Outcome|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
154394|NCT01545336|O2|Outcome|Placebo|"Placebo tablet by mouth once daily for 3 months
Placebo: 1 mg tablet to be taken 1 time daily"
154395|NCT01545336|O1|Outcome|Anastrozole|"1 mg tablet by mouth once daily for 3 months
Anastrozole: 1 mg tablet to be taken 1 time daily"
154396|NCT01545336|E2|Reported Event|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
154397|NCT01545336|E1|Reported Event|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
154398|NCT01545232|B3|Baseline|Total|Total of all reporting groups
154452|NCT01544153|P1|Participant Flow|WEB Only|"Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
154399|NCT01545232|B2|Baseline|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154400|NCT01545232|B1|Baseline|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154401|NCT01545232|P2|Participant Flow|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154402|NCT01545232|P1|Participant Flow|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154403|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154404|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154405|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154406|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154539|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154407|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154408|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154409|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154410|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154411|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154412|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154413|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154414|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154415|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154416|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154417|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154418|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154419|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154420|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154421|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154540|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154422|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154423|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154424|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154425|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154426|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154427|NCT01545232|E2|Reported Event|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
154428|NCT01545232|E1|Reported Event|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
154429|NCT01545193|B3|Baseline|Total|Total of all reporting groups
154430|NCT01545193|B2|Baseline|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154431|NCT01545193|B1|Baseline|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154432|NCT01545193|P2|Participant Flow|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154433|NCT01545193|P1|Participant Flow|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154434|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154435|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154436|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154437|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154438|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154439|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154440|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154441|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154442|NCT01545193|E2|Reported Event|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154443|NCT01545193|E1|Reported Event|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade
Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
154444|NCT01544153|B5|Baseline|Total|Total of all reporting groups
154445|NCT01544153|B4|Baseline|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
154446|NCT01544153|B3|Baseline|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
154447|NCT01544153|B2|Baseline|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
154448|NCT01544153|B1|Baseline|WEB Only|"Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
154449|NCT01544153|P4|Participant Flow|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
154450|NCT01544153|P3|Participant Flow|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
154451|NCT01544153|P2|Participant Flow|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
154453|NCT01544153|O4|Outcome|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
154454|NCT01544153|O3|Outcome|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
154455|NCT01544153|O2|Outcome|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
154456|NCT01544153|O1|Outcome|WEB Only|"Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
154457|NCT01544153|O4|Outcome|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
154458|NCT01544153|O3|Outcome|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
154459|NCT01544153|O2|Outcome|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
154460|NCT01544153|O1|Outcome|WEB Only|"Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
154482|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154461|NCT01544153|E4|Reported Event|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
154462|NCT01544153|E3|Reported Event|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
154463|NCT01544153|E2|Reported Event|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
154464|NCT01544153|E1|Reported Event|WEB Only|"Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
154465|NCT01544062|B3|Baseline|Total|Total of all reporting groups
154466|NCT01544062|B2|Baseline|Normal Saline|Study subjects receiving placebo
154467|NCT01544062|B1|Baseline|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154468|NCT01544062|P2|Participant Flow|Normal Saline|Study subjects receiving placebo
154469|NCT01544062|P1|Participant Flow|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154470|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154471|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154559|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
170918|NCT01477463|O2|Outcome|Arm B: Placebo|Placebo (inactive capsule)
154472|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154473|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154474|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154475|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154476|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154477|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154478|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154479|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154480|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154481|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154537|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154483|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154484|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154485|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154486|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154487|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154488|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154489|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154490|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154491|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154925|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
154492|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154493|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154494|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154495|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154496|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154497|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154498|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154499|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154500|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154501|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
154502|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154503|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
191295|NCT01405794|O2|Outcome|32ppm Oral Silver|
154504|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154505|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
154506|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154507|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
154508|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154509|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
154510|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154511|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154512|NCT01544062|E2|Reported Event|IV Acetaminophen|"Study subjects receiving IV acetaminophen
IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154513|NCT01544062|E1|Reported Event|Normal Saline|"Study subjects receiving placebo
Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
154514|NCT01544023|B1|Baseline|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
154560|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154515|NCT01544023|P1|Participant Flow|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
154516|NCT01544023|O1|Outcome|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
154517|NCT01544023|O1|Outcome|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
154518|NCT01544023|E1|Reported Event|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
154519|NCT01543958|B1|Baseline|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154520|NCT01543958|P1|Participant Flow|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154521|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154522|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154523|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154524|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154525|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154526|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154527|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154528|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154529|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154530|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154531|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154532|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154533|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154534|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154535|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154536|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154541|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154542|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154543|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154544|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154545|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154546|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154547|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154548|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154549|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154550|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154551|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154552|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154553|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154554|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154555|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154556|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154557|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154558|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154705|NCT01544348|P5|Participant Flow|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
154561|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154562|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154563|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154564|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154565|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154566|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154567|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154568|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154569|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154570|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154571|NCT01543958|E1|Reported Event|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
154572|NCT01544998|B1|Baseline|Entire Study Population|Includes groups randomized to receive Tadalafil plus Nesiritide first, and Tadalafil plus Placebo first.
154573|NCT01544998|P2|Participant Flow|Tadalafil Plus Nesiritide, Then Tadalafil Plus Placebo|First intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.
154574|NCT01544998|P1|Participant Flow|Tadalafil Plus Placebo, Then Tadalafil Plus Nesiritide|First intervention period: oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.
154677|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
154678|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
191296|NCT01405794|O1|Outcome|Placebo|
154575|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
154576|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
154577|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
154578|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
154579|NCT01544998|E4|Reported Event|PDD: Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
154580|NCT01544998|E3|Reported Event|PDD: Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
154581|NCT01544998|E2|Reported Event|PSD: Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
154926|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
154582|NCT01544998|E1|Reported Event|PSD: Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
154583|NCT01544920|B3|Baseline|Total|Total of all reporting groups
154584|NCT01544920|B2|Baseline|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
154585|NCT01544920|B1|Baseline|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
154586|NCT01544920|P2|Participant Flow|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
154587|NCT01544920|P1|Participant Flow|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
154588|NCT01544920|O2|Outcome|Arm 2a: BOC + Peg-IFN + RBV 24 Weeks|Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of BOC + peg-IFN + RBV for a total of 24 weeks of BOC (added at Week 4) + peg-IFN + RBV therapy.
154589|NCT01544920|O1|Outcome|Arm 1a: Peg-IFN + RBV 24 Weeks|Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of peg-IFN + RBV for a total of 24 weeks of peg-IFN + RBV therapy.
154590|NCT01544920|O2|Outcome|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
154679|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154680|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154591|NCT01544920|O1|Outcome|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
154592|NCT01544920|E2|Reported Event|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
154593|NCT01544920|E1|Reported Event|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
154594|NCT01544582|B4|Baseline|Total|Total of all reporting groups
154595|NCT01544582|B3|Baseline|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
154596|NCT01544582|B2|Baseline|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
154597|NCT01544582|B1|Baseline|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
154598|NCT01544582|P4|Participant Flow|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
154599|NCT01544582|P3|Participant Flow|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
154600|NCT01544582|P2|Participant Flow|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
154601|NCT01544582|P1|Participant Flow|All Included Participants|All CHC genotype-1 participants included in study.
154645|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
154646|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
154647|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
154927|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
154602|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
154603|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
154604|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
154605|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
154606|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
154607|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
154608|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
154609|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
154681|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
154682|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
191297|NCT01405794|O2|Outcome|32ppm Oral Silver|
154610|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
154611|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
154612|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
154613|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
154614|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
154615|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
154616|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
154617|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
154618|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
154619|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
154620|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
154621|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
154622|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
154623|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
154624|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
154625|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
154626|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
154648|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
154649|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
154706|NCT01544348|P4|Participant Flow|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
154627|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
154628|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
154629|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
154630|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
154631|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
154632|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
154633|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
154634|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
154683|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154684|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154685|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154635|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
154636|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
154637|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
154638|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
154639|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
154640|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
154641|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
154642|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
154643|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
154644|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
154928|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
154650|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
154651|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
154652|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
154653|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
154654|NCT01544582|O1|Outcome|All Included Participants|All CHC genotype-1 participants included in study.
154655|NCT01544582|E3|Reported Event|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
154656|NCT01544582|E2|Reported Event|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
154657|NCT01544582|E1|Reported Event|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
154658|NCT01544478|B1|Baseline|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
154659|NCT01544478|P1|Participant Flow|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
154660|NCT01544478|O1|Outcome|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
154661|NCT01544478|E1|Reported Event|V501|Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
154662|NCT01544361|B6|Baseline|TOTAL|Total of all reporting groups
154663|NCT01544361|B5|Baseline|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154664|NCT01544361|B4|Baseline|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154665|NCT01544361|B3|Baseline|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154666|NCT01544361|B2|Baseline|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
154667|NCT01544361|B1|Baseline|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
154668|NCT01544361|P5|Participant Flow|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154669|NCT01544361|P4|Participant Flow|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154670|NCT01544361|P3|Participant Flow|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154671|NCT01544361|P2|Participant Flow|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
154672|NCT01544361|P1|Participant Flow|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
154673|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154674|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154675|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154676|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
191298|NCT01405794|O1|Outcome|Placebo|
154686|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
154687|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
154688|NCT01544361|E5|Reported Event|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154689|NCT01544361|E4|Reported Event|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154690|NCT01544361|E3|Reported Event|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
154691|NCT01544361|E2|Reported Event|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
154692|NCT01544361|E1|Reported Event|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
154693|NCT01544348|B9|Baseline|Total|Total of all reporting groups
154694|NCT01544348|B8|Baseline|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
154695|NCT01544348|B7|Baseline|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
154696|NCT01544348|B6|Baseline|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
154697|NCT01544348|B5|Baseline|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
154698|NCT01544348|B4|Baseline|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
154699|NCT01544348|B3|Baseline|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
154700|NCT01544348|B2|Baseline|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
154701|NCT01544348|B1|Baseline|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
154702|NCT01544348|P8|Participant Flow|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
154703|NCT01544348|P7|Participant Flow|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
154704|NCT01544348|P6|Participant Flow|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
173147|NCT01470417|B3|Baseline|Total|Total of all reporting groups
154707|NCT01544348|P3|Participant Flow|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
154708|NCT01544348|P2|Participant Flow|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
154709|NCT01544348|P1|Participant Flow|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
154710|NCT01544348|O8|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
154711|NCT01544348|O7|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
154712|NCT01544348|O6|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
154713|NCT01544348|O5|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
154714|NCT01544348|O4|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
154715|NCT01544348|O3|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
154716|NCT01544348|O2|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
154717|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
154718|NCT01544348|O7|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
154719|NCT01544348|O6|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
154720|NCT01544348|O5|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
154721|NCT01544348|O4|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
154722|NCT01544348|O3|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
154723|NCT01544348|O2|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
154724|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
154725|NCT01544348|O7|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
154726|NCT01544348|O6|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
154727|NCT01544348|O5|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
154728|NCT01544348|O4|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
154729|NCT01544348|O3|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
154730|NCT01544348|O2|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
154731|NCT01544348|O1|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
154732|NCT01544348|O8|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
154733|NCT01544348|O7|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
154737|NCT01544348|O3|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
154738|NCT01544348|O2|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
154739|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
154740|NCT01544348|E8|Reported Event|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
154741|NCT01544348|E7|Reported Event|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
154742|NCT01544348|E6|Reported Event|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
154743|NCT01544348|E5|Reported Event|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
154744|NCT01544348|E4|Reported Event|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
154745|NCT01544348|E3|Reported Event|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
154746|NCT01544348|E2|Reported Event|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
154747|NCT01544348|E1|Reported Event|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
154748|NCT01544309|B3|Baseline|Total|Total of all reporting groups
154749|NCT01544309|B2|Baseline|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154750|NCT01544309|B1|Baseline|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154751|NCT01544309|P2|Participant Flow|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.)"
154752|NCT01544309|P1|Participant Flow|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in the Japan Atherosclerosis Society (JAS) Guidelines (GL) after 3 months, had the atorvastatin [ATV] dose of 20 mg.)"
173359|NCT01469182|B3|Baseline|Total|Total of all reporting groups
154753|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154754|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154755|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154756|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154757|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154758|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154759|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154760|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154761|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154762|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154763|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154764|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154765|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154766|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154799|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154800|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154767|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154768|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154769|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154770|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154771|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154772|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154773|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154774|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154775|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154776|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154822|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154929|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
154777|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154778|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154779|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154780|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154781|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154782|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154783|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154784|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154785|NCT01544309|E2|Reported Event|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
154786|NCT01544309|E1|Reported Event|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
154787|NCT01544179|B3|Baseline|Total|Total of all reporting groups
154788|NCT01544179|B2|Baseline|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154789|NCT01544179|B1|Baseline|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154790|NCT01544179|P2|Participant Flow|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154791|NCT01544179|P1|Participant Flow|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154792|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154793|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154794|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154795|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154796|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154797|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154798|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
191299|NCT01405794|O2|Outcome|32ppm Oral Silver|
154801|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154802|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154803|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154804|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154805|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154806|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154807|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154808|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154809|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154810|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154811|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154812|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154813|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154814|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154815|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154816|NCT01544179|E2|Reported Event|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
154817|NCT01544179|E1|Reported Event|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
154818|NCT01544166|B1|Baseline|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154819|NCT01544166|P1|Participant Flow|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154820|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154821|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154923|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
154823|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154824|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154825|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154826|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154827|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154828|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154829|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154830|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154831|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154832|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154833|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154834|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154835|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154836|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154837|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154838|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154839|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154840|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154841|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154842|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154843|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154844|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154845|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154846|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154847|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154848|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154849|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154850|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154851|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154852|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154853|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154854|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154855|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154856|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154857|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154858|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154859|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154860|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154861|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154862|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154863|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154864|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154865|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154866|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154867|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154868|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154924|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
154869|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
154870|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
154871|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154872|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154873|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154874|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154875|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154876|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154877|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154878|NCT01544166|E1|Reported Event|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
154879|NCT01543828|B3|Baseline|Total|Total of all reporting groups
154880|NCT01543828|B2|Baseline|Placebo Then Indacaterol|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
154881|NCT01543828|B1|Baseline|Indacaterol Then Placebo|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
154882|NCT01543828|P2|Participant Flow|Placebo Then Indacaterol|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
154883|NCT01543828|P1|Participant Flow|Indacaterol Then Placebo|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
154884|NCT01543828|O4|Outcome|placebo_treatment 2|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
154885|NCT01543828|O3|Outcome|placebo_treatment 1|In treatment 1, participants received placebo one dose delivered via SDDPI. Albuterol was available for use as rescue medication.
154886|NCT01543828|O2|Outcome|indacaterol_treatment 2|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
154887|NCT01543828|O1|Outcome|indacaterol_treatment 1|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI). Albuterol was available for use as rescue medication.
154888|NCT01543828|E2|Reported Event|Placebo|Participants received placebo one dose delivered via SDDPI.
154889|NCT01543828|E1|Reported Event|Indacaterol|Participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI).
154890|NCT01543685|B6|Baseline|Total|Total of all reporting groups
154891|NCT01543685|B5|Baseline|Placebo|Placebo : Capsules
154892|NCT01543685|B4|Baseline|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
154893|NCT01543685|B3|Baseline|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
154894|NCT01543685|B2|Baseline|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
154895|NCT01543685|B1|Baseline|Celecoxib 200 mg|Celecoxib : 200 mg capsules
154896|NCT01543685|P5|Participant Flow|Placebo|Placebo : Capsules
154897|NCT01543685|P4|Participant Flow|Celecoxib 200 mg|Celecoxib : 200 mg capsules
154898|NCT01543685|P3|Participant Flow|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
154899|NCT01543685|P2|Participant Flow|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
154900|NCT01543685|P1|Participant Flow|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
154901|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
154902|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
154903|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
154904|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
154905|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
154906|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
154907|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
154908|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
154909|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
154910|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
154911|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
154912|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
154913|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
154914|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
154915|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
154916|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
154917|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
154918|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
154919|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
154920|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
154921|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
154922|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
154930|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
154931|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
154932|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
154933|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
154934|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
154935|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
154936|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
154937|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
154938|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
154939|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
154940|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
154941|NCT01543685|E5|Reported Event|Placebo|Placebo : Capsules
154942|NCT01543685|E4|Reported Event|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
154943|NCT01543685|E3|Reported Event|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
154944|NCT01543685|E2|Reported Event|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
154945|NCT01543685|E1|Reported Event|Celecoxib 200 mg|Celecoxib : 200 mg capsules
154946|NCT01543607|B1|Baseline|Treatment|"Radiofrequency ablation catheter
Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
154947|NCT01543607|P1|Participant Flow|Treatment|"Radiofrequency ablation catheter
Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
154948|NCT01543607|O1|Outcome|Treatment|"Radiofrequency ablation catheter
Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
154949|NCT01543607|O1|Outcome|Treatment|"Radiofrequency ablation catheter
Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
154950|NCT01543607|O1|Outcome|Treatment|"Radiofrequency ablation catheter
Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
154951|NCT01543607|E1|Reported Event|Treatment|"Radiofrequency ablation catheter
Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
154952|NCT01543581|B1|Baseline|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
154953|NCT01543581|P2|Participant Flow|Inactive Placebo|Those to whom the inactive placebo is given.
154954|NCT01543581|P1|Participant Flow|Vismodegib|Those to whom the drug is given.
154955|NCT01543581|O1|Outcome|Vismodegib|Those to whom the drug is given.
154956|NCT01543581|O1|Outcome|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
154957|NCT01543581|E2|Reported Event|Inactive Placebo|Those to whom the inactive placebo is given.
154958|NCT01543581|E1|Reported Event|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
154959|NCT01543568|B1|Baseline|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
155191|NCT01542632|E6|Reported Event|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
154960|NCT01543568|P1|Participant Flow|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
154961|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
154962|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
154963|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
154964|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
154965|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
154966|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
154967|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
154968|NCT01543568|E1|Reported Event|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
154969|NCT01543503|B3|Baseline|Total|Total of all reporting groups
156600|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
154970|NCT01543503|B2|Baseline|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154971|NCT01543503|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154972|NCT01543503|P2|Participant Flow|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154973|NCT01543503|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154974|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154975|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154989|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154976|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154977|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154978|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154979|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154980|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154981|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154982|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154983|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154984|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154985|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154986|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154987|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154988|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
191300|NCT01405794|O1|Outcome|Placebo|
154990|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154991|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154992|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154993|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154994|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154995|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154996|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154997|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154998|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
154999|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155000|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155001|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155002|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
191301|NCT01405794|O2|Outcome|32ppm Oral Silver|
155003|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155004|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155005|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155006|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155007|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155008|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155009|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155010|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155011|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155012|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155013|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155014|NCT01543503|E2|Reported Event|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
155015|NCT01543503|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
191302|NCT01405794|O1|Outcome|Placebo|
155016|NCT01543204|B1|Baseline|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155017|NCT01543204|P1|Participant Flow|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155018|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155019|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155020|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155021|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155022|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155023|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155024|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155025|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155026|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155027|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155028|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155029|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155030|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155031|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155032|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155033|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
155034|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155035|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155036|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
155037|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155038|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155039|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
155040|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155041|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155042|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
155043|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155044|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155045|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
155046|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155071|NCT01543178|E1|Reported Event|Total Open-label Experience|"This group includes all 2579 subjects who received rifaximin the open-label period.
Open-label experience is shown here."
155047|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155048|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155049|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155050|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155051|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
155052|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155053|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155054|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155055|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155056|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155057|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
155058|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155059|NCT01543204|E1|Reported Event|Etanercept 50mg BIW/50mg QW|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
155060|NCT01543178|B4|Baseline|Total|Total of all reporting groups
155242|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack
Room air: Placebo"
155061|NCT01543178|B3|Baseline|Double-blind Placebo (Retreatment)|The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.
155062|NCT01543178|B2|Baseline|Double-blind Rifaximin (Retreatment)|The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.
155063|NCT01543178|B1|Baseline|Open-label Rifaximin Only|The 1943 subjects in this group did not continue into the double-blind period of the study. Open-label treatment was rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up.
155064|NCT01543178|P3|Participant Flow|Double-blind Placebo (Retreatment)|The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.
155065|NCT01543178|P2|Participant Flow|Double-blind Rifaximin (Retreatment)|The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.
155066|NCT01543178|P1|Participant Flow|Open-label Rifaximin|"Subjects received open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders continued into Maintenance Phase 1 (treatment free). Nonresponders withdrew from the study.
Of the 2583 subjects in this group, 636 eventually met criteria for recurrence in Maintenance Phase 1, entered the double-blind period, and were randomized 1:1 to receive rifaximin 550 mg or placebo."
155067|NCT01543178|O2|Outcome|Double-blind Placebo (Retreatment)|"The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.
During the double-blind period, subjects in this arm received placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with placebo."
155068|NCT01543178|O1|Outcome|Double-blind Rifaximin (Retreatment)|"The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.
During the double-blind period, subjects in this arm received rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with rifaximin."
155069|NCT01543178|E3|Reported Event|Double-blind Retreatment Experience - Placebo Group|"The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.
During the double-blind period, subjects in this arm received placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with placebo.
Double-blind experience is shown here."
155070|NCT01543178|E2|Reported Event|Double-blind Retreatment Experience - Rifaximin Group|"The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.
During the double-blind period, subjects in this arm received rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with rifaximin.
Double-blind experience is shown here."
155073|NCT01543074|B4|Baseline|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE plus garlic oil placebo: see arm description"
155074|NCT01543074|B3|Baseline|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE & Garlic Oil: see arm description"
155075|NCT01543074|B2|Baseline|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE placebo & garlic oil placebo: see arm description
BSE plus garlic oil placebo: see arm description"
155076|NCT01543074|B1|Baseline|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo & garlic oil placebo: see arm description
BSE & Garlic Oil: see arm description"
155077|NCT01543074|P4|Participant Flow|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE plus garlic oil placebo: see arm description"
155078|NCT01543074|P3|Participant Flow|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE & Garlic Oil: see arm description"
155079|NCT01543074|P2|Participant Flow|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE placebo & garlic oil placebo: see arm description
BSE plus garlic oil placebo: see arm description"
155080|NCT01543074|P1|Participant Flow|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo & garlic oil placebo: see arm description
BSE & Garlic Oil: see arm description"
155081|NCT01543074|O4|Outcome|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days
Garlic oil: 1 pill = 30 mg garlic oil/day
BSE: 2 pills = 200 micromoles of Sulforaphane/day"
155082|NCT01543074|O3|Outcome|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days
BSE: 2 pills = 200 micromoles of Sulforaphane/day
Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day"
155083|NCT01543074|O2|Outcome|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day
Garlic oil: 1 pill = 30 mg garlic oil/day"
155084|NCT01543074|O1|Outcome|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day
Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day"
155085|NCT01543074|O4|Outcome|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE plus garlic oil placebo: see arm description"
155243|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack
Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
155086|NCT01543074|O3|Outcome|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE & Garlic Oil: see arm description"
155087|NCT01543074|O2|Outcome|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE placebo & garlic oil placebo: see arm description
BSE plus garlic oil placebo: see arm description"
155088|NCT01543074|O1|Outcome|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo & garlic oil placebo: see arm description
BSE & Garlic Oil: see arm description"
155089|NCT01543074|E4|Reported Event|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE plus garlic oil placebo: see arm description"
155090|NCT01543074|E3|Reported Event|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE & Garlic Oil: see arm description"
155091|NCT01543074|E2|Reported Event|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE placebo & garlic oil placebo: see arm description
BSE plus garlic oil placebo: see arm description"
155092|NCT01543074|E1|Reported Event|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo & garlic oil placebo: see arm description
BSE & Garlic Oil: see arm description"
155093|NCT01542957|B3|Baseline|Total|Total of all reporting groups
155094|NCT01542957|B2|Baseline|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
155095|NCT01542957|B1|Baseline|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
155096|NCT01542957|P2|Participant Flow|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
155097|NCT01542957|P1|Participant Flow|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
155098|NCT01542957|O2|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
155099|NCT01542957|O1|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
155100|NCT01542957|O2|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
155298|NCT01541969|E1|Reported Event|Acoustic CR Neuromodulation|see Protocol section for details
155101|NCT01542957|O1|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
155102|NCT01542957|O2|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
155103|NCT01542957|O1|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
155104|NCT01542957|E2|Reported Event|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
155105|NCT01542957|E1|Reported Event|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
155106|NCT01542788|B3|Baseline|Total|Total of all reporting groups
155107|NCT01542788|B2|Baseline|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
155108|NCT01542788|B1|Baseline|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
155109|NCT01542788|P2|Participant Flow|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
155110|NCT01542788|P1|Participant Flow|SOF+RBV|Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
155244|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack
Room air: Placebo"
155111|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
155112|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
155113|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
155114|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
155115|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
155116|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
155117|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
155118|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
155119|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
155120|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
155121|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
155122|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
155123|NCT01542788|E2|Reported Event|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
155124|NCT01542788|E1|Reported Event|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
155125|NCT01542684|B1|Baseline|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.
GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.
Each treatment cycle lasts at least 4 weeks."
155126|NCT01542684|P1|Participant Flow|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.
Granulocyte-macrophage colony-stimulating factor (GM-CSF) administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.
Each treatment cycle lasts at least 4 weeks."
155299|NCT01541930|B1|Baseline|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
155127|NCT01542684|O1|Outcome|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.
GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.
Each treatment cycle will last at least 4 weeks
Azacytidine: Starting dose: 40 mg/m^2 intravenously (IV) or subcutaneously (SQ) daily for 4 days.
GM-CSF: 250 mcg/m^2 IV or SQ one day (the next day) after completion of azacytidine treatment, for 3 consecutive days."
155128|NCT01542684|E1|Reported Event|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.
GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.
Each treatment cycle lasts at least 4 weeks."
155129|NCT01542645|B3|Baseline|Total|Total of all reporting groups
155130|NCT01542645|B2|Baseline|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
155131|NCT01542645|B1|Baseline|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
155132|NCT01542645|P2|Participant Flow|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
155133|NCT01542645|P1|Participant Flow|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
155134|NCT01542645|O2|Outcome|Fentanyl|
155135|NCT01542645|O1|Outcome|Methadone|
155136|NCT01542645|O2|Outcome|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
155137|NCT01542645|O1|Outcome|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
155138|NCT01542645|O2|Outcome|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
155139|NCT01542645|O1|Outcome|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
155140|NCT01542645|E2|Reported Event|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
155141|NCT01542645|E1|Reported Event|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
155142|NCT01542632|B7|Baseline|Total|Total of all reporting groups
155143|NCT01542632|B6|Baseline|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
155144|NCT01542632|B5|Baseline|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155145|NCT01542632|B4|Baseline|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155146|NCT01542632|B3|Baseline|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
155147|NCT01542632|B2|Baseline|Group 2 (DO:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
155148|NCT01542632|B1|Baseline|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
155149|NCT01542632|P6|Participant Flow|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
155150|NCT01542632|P5|Participant Flow|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155151|NCT01542632|P4|Participant Flow|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155152|NCT01542632|P3|Participant Flow|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
155153|NCT01542632|P2|Participant Flow|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
155154|NCT01542632|P1|Participant Flow|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
155155|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
155156|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155157|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155158|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
155159|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
155160|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
155161|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
155162|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155163|NCT01542632|O4|Outcome|Group 4 (D0:TDV,P D90:TDV,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155164|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
155165|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
155166|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
155167|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
155168|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155169|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155170|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
155245|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack
Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
155171|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
155172|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
155173|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
155174|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155175|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155176|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
155177|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
155178|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
155179|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
155180|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155181|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155182|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
155183|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
155184|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
155185|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
155186|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155187|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155188|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.
155189|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
155190|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
191303|NCT01405794|O2|Outcome|32ppm Oral Silver|
155192|NCT01542632|E5|Reported Event|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155193|NCT01542632|E4|Reported Event|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
155194|NCT01542632|E3|Reported Event|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
155195|NCT01542632|E2|Reported Event|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
155196|NCT01542632|E1|Reported Event|Group 1 (D0:TDV,P D90:TDV)|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
155197|NCT01542541|B3|Baseline|Total|Total of all reporting groups
155198|NCT01542541|B2|Baseline|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
155199|NCT01542541|B1|Baseline|Rifaximin|Rifaximin: 550mg BID for 2 days
155200|NCT01542541|P2|Participant Flow|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
155201|NCT01542541|P1|Participant Flow|Rifaximin|Rifaximin: 550mg BID for 2 days
155202|NCT01542541|O2|Outcome|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
155203|NCT01542541|O1|Outcome|Rifaximin|Rifaximin: 550mg BID for 2 days
155204|NCT01542541|E2|Reported Event|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
155205|NCT01542541|E1|Reported Event|Rifaximin|Rifaximin: 550mg BID for 2 days
155206|NCT01542502|B1|Baseline|All Participants|Baseline measures for all study participants
155207|NCT01542502|P2|Participant Flow|Placebo (First) Then Anakinra (Second)|"Treatment with daily subcutaneous injections of Placebo for 14 days, followed by daily subcutaneous injections of Anakinra for 14 days
Placebo: Placebo daily subcutaneous injection Anakinra: Anakinra 100 mg daily subcutaneous injection"
155208|NCT01542502|P1|Participant Flow|Anakinra (First) Then Placebo (Second)|"Treatment with daily subcutaneous injections of Anakinra 100 mg for 14 days, followed by daily subcutaneous injections of Placebo for 14 days
Anakinra: Anakinra 100 mg daily subcutaneous injection Placebo: Placebo daily subcutaneous injection"
155209|NCT01542502|O2|Outcome|Placebo|"Treatment with daily subcutaneous injection of placebo
Placebo: Placebo daily subcutaneous injection"
155210|NCT01542502|O1|Outcome|Anakinra|"Treatment with daily subcutaneous injections of Anakinra
Anakinra: Anakinra 100 mg daily subcutaneous injection"
155211|NCT01542502|O2|Outcome|Placebo|"Treatment with daily subcutaneous injection of placebo
Placebo: Placebo daily subcutaneous injection"
155212|NCT01542502|O1|Outcome|Anakinra|"Treatment with daily subcutaneous injections of Anakinra 100 mg
Anakinra: Anakinra 100 mg daily subcutaneous injection"
155213|NCT01542502|E2|Reported Event|Placebo|"Treatment with daily subcutaneous injection of placebo
Placebo: Placebo daily subcutaneous injection"
155214|NCT01542502|E1|Reported Event|Anakinra|"Treatment with daily subcutaneous injections of Anakinra 100 mg
Anakinra: Anakinra 100 mg daily subcutaneous injection"
155215|NCT01542372|B1|Baseline|Step I: SSRI/SSRN Treatment of PTSD|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155216|NCT01542372|P2|Participant Flow|CBT Augmentation|"In this arm, patients were given CBT to treat SSRI/SSRN-resistant PTSD.
Cognitive Behavioral Therapy for PTSD: This is a culturally sensitive CBT for the treatment of PTSD"
155217|NCT01542372|P1|Participant Flow|Medication Augmentation (Prazosin)|"In this arm, the patients were given a medication augmentation for SSRI/SSRN-resistant PTSD, with the preferred first-line agent being prazosin.
Prazosin as first-line agent: Prazosin .5 to 2 mg"
155218|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155219|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155220|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155221|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155222|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155223|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155224|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155225|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155226|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155439|NCT01541735|E1|Reported Event|Pantoprazole|The pantoprazole will be administered in 40mg capsules
155227|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155228|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155229|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
155230|NCT01542372|E1|Reported Event|Step I and Step 2|Step 1 is treatment with SSRI or SSRN. Step 2 is Medication or CBT augmentation.
155231|NCT01542307|B1|Baseline|Enrolled Subjects|Oxygen or Medical Air is inhaled in random order for 30 minutes during each migraine attack (total 4 attacks)
155232|NCT01542307|P2|Participant Flow|Medical Air-treated Migraine Attacks|Medical air is inhaled for 30 minutes during a migraine attack
155233|NCT01542307|P1|Participant Flow|Oxygen-treated Migraine Attacks|Oxygen is inhaled for 30 minutes during a migraine attack
155234|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack
Room air: Placebo"
155235|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack
Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
155236|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack
Room air: Placebo"
155237|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack
Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
155238|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack
Room air: Placebo"
155239|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack
Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
155240|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack
Room air: Placebo"
155241|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack
Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
155246|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack
Room air: Placebo"
155247|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack
Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
155248|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack
Room air: Placebo"
155249|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack
Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
155250|NCT01542307|E2|Reported Event|Room Air|"Medical air inhaled for 30 minutes during migraine attack
Room air: Placebo"
155251|NCT01542307|E1|Reported Event|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack
Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
155252|NCT01542255|B1|Baseline|Combined Low Dose Treatment|"A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.
Schema of treatment is:
1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv
vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.
Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest
dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest"
155253|NCT01542255|P1|Participant Flow|Combined Low Dose Treatment|"A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.
Schema of treatment is:
1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv
vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.
Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest
dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest"
155254|NCT01542255|O1|Outcome|Single Arm|
155255|NCT01542255|E1|Reported Event|Single Arm|all patients received cyclophosphamide, DTIC and vinblastine
155256|NCT01542125|B3|Baseline|Total|Total of all reporting groups
155257|NCT01542125|B2|Baseline|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.
Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
155258|NCT01542125|B1|Baseline|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing
Liposomal Lidocaine: 4% Liposomal Lidocaine"
155259|NCT01542125|P2|Participant Flow|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.
Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
155260|NCT01542125|P1|Participant Flow|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing
Liposomal Lidocaine: 4% Liposomal Lidocaine"
155261|NCT01542125|O2|Outcome|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.
Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
155262|NCT01542125|O1|Outcome|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing
Liposomal Lidocaine: 4% Liposomal Lidocaine"
155300|NCT01541930|P1|Participant Flow|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
155472|NCT01541384|B4|Baseline|Total|Total of all reporting groups
155263|NCT01542125|E2|Reported Event|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.
Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
155264|NCT01542125|E1|Reported Event|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing
Liposomal Lidocaine: 4% Liposomal Lidocaine"
155265|NCT01542034|B3|Baseline|Total|Total of all reporting groups
155266|NCT01542034|B2|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155267|NCT01542034|B1|Baseline|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155268|NCT01542034|P2|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155269|NCT01542034|P1|Participant Flow|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155270|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155271|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155272|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155273|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155274|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155275|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155276|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155277|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155278|NCT01542034|E2|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155279|NCT01542034|E1|Reported Event|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
155280|NCT01541969|B3|Baseline|Total|Total of all reporting groups
155281|NCT01541969|B2|Baseline|Tinnitus Masking|see Protocol section for details
155282|NCT01541969|B1|Baseline|CR Neuromodulation|see Protocol section for details
155283|NCT01541969|P2|Participant Flow|Tinnitus Masking|"The active control group had the same ear level device which delivers patterned sound stimulation. Participants were asked to wear the device for 4-6 hours per day (0-36 weeks).
The active comparator group received the intervention in a double-blind RCT (0-12 weeks). They received the same device as the treatment group but the sound stimulation was determined according to an algorithm predicted not to break up tinnitus generating activity in the brain. The device may have a tinnitus masking effect in the active comparator group.
After the first 12 weeks, the participants entered into the open-label extension (unblinded, 12-36 weeks) in which they received the verum experimental intervention."
155284|NCT01541969|P1|Participant Flow|CR Neuromodulation|"Acoustic Co-ordinated Reset (CR) Neuromodulation includes an ear level device which delivers patterned sound stimulation. Participants were asked to wear the device for 4-6 hours per day (0-12 weeks) and for at least 4 hours daily (12-36 weeks)
The experimental arm received the intervention in a double-blind RCT (0-12 weeks), with the device fitted according to audiologist training given by the manufacturer/funder. An individually specified sound stimulation algorithm is hypothesised to interrupt tinnitus generating activity in the brain.
After the first 12 weeks, the participants entered into the open-label extension (unblinded, 12-36 weeks) in which they continued with the same experimental intervention."
155285|NCT01541969|O2|Outcome|Tinnitus Masking|The active comparator group were unblinded at 12 weeks and the device algorithm was reprogrammed in the same way as the experimental intervention. At 36 weeks, this group had therefore received a mixture of placebo (0-12 weeks) and active treatment (12-36 weeks).
155286|NCT01541969|O1|Outcome|CR Neuromodulation|The treatment group were unblinded at 12 weeks and then continued to receive the same experimental intervention. At 36 weeks, this group had therefore received active treatment (0-36 weeks).
155287|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
155288|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
155289|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
155290|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
155291|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
155292|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
155293|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details.
155294|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
155295|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
155296|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
155297|NCT01541969|E2|Reported Event|Tinnitus Masking|see Protocol section for details
155301|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Pain evaluation on Day 14 by Visual Analogue Scale (mm) One patient was withdrawn on Day 7 by Subject's request
155302|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Pain evaluation on Day 7 by Visual Analogue Scale (mm)
155303|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Pain evaluation on Day 0 (baseline) by Visual Analogue Scale (mm)
155304|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Appearance score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
155305|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Appearance score evaluated on Day 7
155306|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Appearance score evaluated on Day 0 (baseline)
155307|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
155308|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
155309|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (baseline)
155310|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
155311|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
155312|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (baseline)
155313|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 due to subject's request.
155314|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
155315|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (Baseline)
155316|NCT01541930|O1|Outcome|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
155317|NCT01541930|E1|Reported Event|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30 g
155318|NCT01541917|B4|Baseline|Total|Total of all reporting groups
155319|NCT01541917|B3|Baseline|Never Randomized|This group comprises participants that consented but were never randomized to a condition due to being determined to not meet eligibility criteria or self-withdrawing before randomization.
155320|NCT01541917|B2|Baseline|Online Disease Education Control|The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual health coach to discuss the participant's efforts at managing his/her disease.
155321|NCT01541917|B1|Baseline|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach to review material and help enhance motivation.
155322|NCT01541917|P2|Participant Flow|Online Disease Education Control|"Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.
Online disease education: The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
155323|NCT01541917|P1|Participant Flow|Web-based Coping Skills Training|"Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.
Web-based coping skills training: This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation."
155324|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
155325|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
155326|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
155327|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
155348|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
191304|NCT01405794|O1|Outcome|Placebo|
155328|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
155329|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
155330|NCT01541917|O2|Outcome|Online Disease Education|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
155331|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
155332|NCT01541917|O2|Outcome|Online Disease Education|"Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.
Online disease education: The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
155363|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155364|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155365|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
156601|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
155333|NCT01541917|O1|Outcome|Web-based Coping Skills Training|"Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.
Web-based coping skills training: This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation."
155334|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
155335|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
155336|NCT01541917|E2|Reported Event|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
155337|NCT01541917|E1|Reported Event|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
155338|NCT01541865|B1|Baseline|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155339|NCT01541865|P1|Participant Flow|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155340|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155341|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155342|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155343|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155344|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155345|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155346|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155347|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155349|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155350|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155351|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155352|NCT01541865|E1|Reported Event|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
155353|NCT01541826|B4|Baseline|Total|Total of all reporting groups
155354|NCT01541826|B3|Baseline|Chokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
155355|NCT01541826|B2|Baseline|Chokeberry Extract Capsule|"Chokeberry extract capsule
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks."
155356|NCT01541826|B1|Baseline|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155357|NCT01541826|P3|Participant Flow|Chaokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
155358|NCT01541826|P2|Participant Flow|Chokeberry Extract Capsule|"Chokeberry extract capsule
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose."
155359|NCT01541826|P1|Participant Flow|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155360|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155361|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155362|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155366|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155367|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155368|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155369|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155370|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155371|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155372|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155373|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155374|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155375|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155376|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155377|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155378|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155379|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155380|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155381|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155382|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155383|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155384|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155385|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155386|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155387|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155388|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155389|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155390|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155391|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155392|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155393|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155394|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155395|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155396|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155397|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155398|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155399|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155400|NCT01541826|O1|Outcome|Chokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
155401|NCT01541826|O1|Outcome|Chokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
155402|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155403|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155404|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155405|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155406|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155407|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155408|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
175969|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
155409|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155410|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155411|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155412|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155413|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155414|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155415|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155416|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155417|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155418|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155419|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155420|NCT01541826|O2|Outcome|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155421|NCT01541826|O1|Outcome|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155422|NCT01541826|E3|Reported Event|Chokeberry Extract Capsule (Acute)|Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
155423|NCT01541826|E2|Reported Event|Chokeberry Extract Capsule|Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
155424|NCT01541826|E1|Reported Event|Color-matched Rice Powder Pill|"Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks"
155425|NCT01541735|B3|Baseline|Total|Total of all reporting groups
155426|NCT01541735|B2|Baseline|Placebo|Placebo of calcined magnesia, capsules
155427|NCT01541735|B1|Baseline|Pantoprazole|The pantoprazole will be administered in 40mg capsules
155428|NCT01541735|P2|Participant Flow|Placebo|Placebo of calcined magnesia, capsules PO, 30 minutes before to breakfast during 45 days
155429|NCT01541735|P1|Participant Flow|Pantoprazole|The pantoprazole will be administered in 40mg capsules PO, 30 minutes before to breakfast during 45 days
155430|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
155431|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
155432|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
155433|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
155434|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
155435|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
155436|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
155437|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
155438|NCT01541735|E2|Reported Event|Placebo|Placebo of calcined magnesia, capsules
155440|NCT01541644|B1|Baseline|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.
Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
155441|NCT01541644|P1|Participant Flow|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.
Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
155442|NCT01541644|O1|Outcome|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.
Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
155443|NCT01541644|E1|Reported Event|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.
Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
155444|NCT01541553|B3|Baseline|Total|Total of all reporting groups
155445|NCT01541553|B2|Baseline|Vehicle Gel|"Cryotherapy followed by vehicle gel
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
155446|NCT01541553|B1|Baseline|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
155447|NCT01541553|P2|Participant Flow|Vehicle Gel|"Cryotherapy followed by vehicle gel
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
155448|NCT01541553|P1|Participant Flow|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
155449|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
155450|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
155574|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
155451|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
155452|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
155453|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
155454|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
155455|NCT01541553|E2|Reported Event|Vehicle Gel|"Cryotherapy followed by vehicle gel
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
155456|NCT01541553|E1|Reported Event|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%
Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
155457|NCT01541397|B3|Baseline|Total|Total of all reporting groups
155458|NCT01541397|B2|Baseline|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).
Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
155459|NCT01541397|B1|Baseline|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
155460|NCT01541397|P2|Participant Flow|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).
Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
155461|NCT01541397|P1|Participant Flow|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
155462|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).
Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
155463|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
155464|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).
Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
155465|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
155466|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).
Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
155467|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
155468|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).
Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
155469|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
155470|NCT01541397|E2|Reported Event|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).
Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
155471|NCT01541397|E1|Reported Event|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
155473|NCT01541384|B3|Baseline|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.
Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
155474|NCT01541384|B2|Baseline|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.
Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
155475|NCT01541384|B1|Baseline|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).
Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
155476|NCT01541384|P3|Participant Flow|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.
Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
155489|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
155575|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
155477|NCT01541384|P2|Participant Flow|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.
Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
155478|NCT01541384|P1|Participant Flow|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).
Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
155479|NCT01541384|O3|Outcome|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.
Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
155480|NCT01541384|O2|Outcome|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.
Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
155481|NCT01541384|O1|Outcome|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).
Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
155482|NCT01541384|E3|Reported Event|Usual Care With GlowCap|"Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.
Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated."
155483|NCT01541384|E2|Reported Event|Medicaiton Dosage Reminders + Coordinator Support|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.
Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
191305|NCT01405794|O2|Outcome|32ppm Oral Silver|
155484|NCT01541384|E1|Reported Event|Medication Dosage Reminders|"Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).
Electronic pill bottle: The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function."
155485|NCT01541371|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
155486|NCT01541371|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator’s discretion once daily for 12 weeks.
155487|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
155488|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
155490|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
155491|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
155492|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
155493|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
155494|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
155495|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
155496|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
155497|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
155498|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
155499|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
155500|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
155525|NCT01540981|O1|Outcome|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed
Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
156956|NCT01535365|P1|Participant Flow|Heat|Application of Heat to site of muscle sprain.
155501|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
155502|NCT01541371|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
155503|NCT01541371|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
155504|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
155505|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
155506|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
155507|NCT01541371|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
155508|NCT01541358|B1|Baseline|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|
155570|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
155509|NCT01541358|P1|Participant Flow|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.
A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
155510|NCT01541358|O1|Outcome|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and underwent a PET/CT scan approximately 60 minutes later.
A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
155511|NCT01541358|O1|Outcome|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.
A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
155512|NCT01541358|O1|Outcome|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and underwent a PET/CT scan approximately 60 minutes later.
A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
155513|NCT01541358|E1|Reported Event|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients undergo fluorine F 18 sodium fluoride PET/CT scan.
fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT scan
positron emission tomography/computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT scan"
155514|NCT01541254|B1|Baseline|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
155515|NCT01541254|P1|Participant Flow|Single Arm|"Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.): Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)"
155516|NCT01541254|O1|Outcome|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
155517|NCT01541254|O1|Outcome|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
155518|NCT01541254|E1|Reported Event|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
155519|NCT01540981|B3|Baseline|Total|Total of all reporting groups
155520|NCT01540981|B2|Baseline|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days
MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
155521|NCT01540981|B1|Baseline|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed
Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
155522|NCT01540981|P2|Participant Flow|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days
MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
155523|NCT01540981|P1|Participant Flow|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed
Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
155524|NCT01540981|O2|Outcome|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days
MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
156957|NCT01535365|O2|Outcome|Cold|Application of cold to muscle sprain.
155526|NCT01540981|O2|Outcome|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days
MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
155527|NCT01540981|O1|Outcome|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed
Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
155528|NCT01540981|E2|Reported Event|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days
MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
155529|NCT01540981|E1|Reported Event|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed
Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
155530|NCT01540851|B3|Baseline|Total|Total of all reporting groups
155531|NCT01540851|B2|Baseline|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care
Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.
Subjects assigned to the usual Care group will receive current standard of post-operative care"
155532|NCT01540851|B1|Baseline|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.
Subjects assigned to the usual Care group will receive current standard of post-operative care"
155571|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
155572|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
155573|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
155533|NCT01540851|P2|Participant Flow|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care
Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.
Subjects assigned to the usual Care group will receive current standard of post-operative care"
155534|NCT01540851|P1|Participant Flow|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.
Subjects assigned to the usual Care group will receive current standard of post-operative care"
155535|NCT01540851|O2|Outcome|Usual Care Group|Subjects in the Usual Care group receive the current standard post-operative TKA care
155536|NCT01540851|O1|Outcome|Care Navigator Intervention Group|Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
155537|NCT01540851|O2|Outcome|Usual Care Group|Subjects in the Usual Care group receive the current standard post-operative TKA care
155538|NCT01540851|O1|Outcome|Care Navigator Intervention Group|Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
155539|NCT01540851|O2|Outcome|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care
Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.
Subjects assigned to the usual Care group will receive current standard of post-operative care"
155540|NCT01540851|O1|Outcome|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.
Subjects assigned to the usual Care group will receive current standard of post-operative care"
155541|NCT01540851|E2|Reported Event|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care
Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.
Subjects assigned to the usual Care group will receive current standard of post-operative care"
155542|NCT01540851|E1|Reported Event|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.
Subjects assigned to the usual Care group will receive current standard of post-operative care"
155543|NCT01540825|B12|Baseline|Total|Total of all reporting groups
155544|NCT01540825|B11|Baseline|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
155545|NCT01540825|B10|Baseline|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
155546|NCT01540825|B9|Baseline|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
155547|NCT01540825|B8|Baseline|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
155548|NCT01540825|B7|Baseline|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
155549|NCT01540825|B6|Baseline|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
155550|NCT01540825|B5|Baseline|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
155551|NCT01540825|B4|Baseline|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
155552|NCT01540825|B3|Baseline|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
155553|NCT01540825|B2|Baseline|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
155554|NCT01540825|B1|Baseline|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
155555|NCT01540825|P11|Participant Flow|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
155556|NCT01540825|P10|Participant Flow|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
155557|NCT01540825|P9|Participant Flow|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
155558|NCT01540825|P8|Participant Flow|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
155559|NCT01540825|P7|Participant Flow|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
155560|NCT01540825|P6|Participant Flow|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
155561|NCT01540825|P5|Participant Flow|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
155562|NCT01540825|P4|Participant Flow|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
155563|NCT01540825|P3|Participant Flow|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
155564|NCT01540825|P2|Participant Flow|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
155565|NCT01540825|P1|Participant Flow|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
155566|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
155567|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
155568|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
155569|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
155576|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
155577|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
155578|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
155579|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
155580|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
155581|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
155582|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
155583|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
155584|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
155585|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
155586|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
155587|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
155588|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
155589|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
155590|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
155591|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
155592|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
155593|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
155594|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
155595|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
155596|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
155597|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
155598|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
155599|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
155600|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
155601|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
155602|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
155603|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
155604|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
155605|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
155606|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
155607|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
155608|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
155609|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
155610|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
155611|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
155612|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
155613|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
155614|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
155615|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
155616|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
155617|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
155618|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
155619|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
155620|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
155621|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
155622|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
155623|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
155624|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
155625|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
155626|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
155627|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
156602|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
155628|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
155629|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
155630|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
155631|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
155632|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
155633|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
155634|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
155635|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
155636|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
155637|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
155638|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
155639|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
155640|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
155641|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
155642|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
155643|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
155644|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
155645|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
155646|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
155647|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
155648|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
155649|NCT01540825|E11|Reported Event|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
155650|NCT01540825|E10|Reported Event|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
155651|NCT01540825|E9|Reported Event|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
155652|NCT01540825|E8|Reported Event|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
155653|NCT01540825|E7|Reported Event|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
155654|NCT01540825|E6|Reported Event|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
155655|NCT01540825|E5|Reported Event|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
155656|NCT01540825|E4|Reported Event|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
155657|NCT01540825|E3|Reported Event|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
155658|NCT01540825|E2|Reported Event|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
191306|NCT01405794|O1|Outcome|Placebo|
155659|NCT01540825|E1|Reported Event|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
155660|NCT01540773|B1|Baseline|All Study Participants|Participants received either an egg breakfast or an isocaloric bagel breakfast.
155661|NCT01540773|P2|Participant Flow|Placebo - Amino Acid Supplement|Placebo
155662|NCT01540773|P1|Participant Flow|Amino Acid Supplement - Placebo|"supplements with the proprietary amino acid derivative blend.
Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
155663|NCT01540773|O2|Outcome|Placebo - Amino Acid Supplement|Placebo
155664|NCT01540773|O1|Outcome|Amino Acid Supplement - Placebo|"supplements with the proprietary amino acid derivative blend.
Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
155665|NCT01540773|O2|Outcome|Placebo|"Non-Active
Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
155666|NCT01540773|O1|Outcome|Amino Acid Supplement|"supplements with the proprietary amino acid derivative blend.
Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative
A single dose of amino acids can significantly increase GH levels after 120 minutes in healthy men and women. Whether these GH changes persist over a longer duration or have other positive effects is being further examined."
155667|NCT01540773|O2|Outcome|Placebo|"Non-Active
Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
155668|NCT01540773|O1|Outcome|Amino Acid Supplement|"supplements with the proprietary amino acid derivative blend.
Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative
A single dose of amino acids can significantly increase GH levels after 120 minutes in healthy men and women. Whether these GH changes persist over a longer duration or have other positive effects is being further examined."
155669|NCT01540773|E2|Reported Event|Placebo|"Non-Active
Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
155670|NCT01540773|E1|Reported Event|Amino Acid Supplement|"supplements with the proprietary amino acid derivative blend.
Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
155671|NCT01540487|B3|Baseline|Total|Total of all reporting groups
155672|NCT01540487|B2|Baseline|Lina 2.5mg, Metformin 500mg|All patients receiving Linagliptin 2.5mg and Metformin 500mg.
155673|NCT01540487|B1|Baseline|Lina 2.5mg, Metformin 850mg|All patients receiving Linagliptin 2.5mg and Metformin 850mg.
156603|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
155674|NCT01540487|P2|Participant Flow|Lina 2.5mg, Metformin 500mg|All patients receiving Linagliptin 2.5mg and Metformin 500mg.
155675|NCT01540487|P1|Participant Flow|Lina 2.5mg, Metformin 850mg|All patients receiving Linagliptin 2.5mg and Metformin 850mg.
155676|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
155677|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
155678|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
155679|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
155680|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
155681|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
155682|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
155683|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
155684|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
155685|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
155686|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
155687|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
155688|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
155689|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
155690|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
155691|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
155692|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
155693|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
155694|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
155695|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
155696|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
155697|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
155698|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
191307|NCT01405794|O2|Outcome|32ppm Oral Silver|
155699|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
155700|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
155701|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
155702|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
155703|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
155704|NCT01540487|E4|Reported Event|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
155705|NCT01540487|E3|Reported Event|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
155706|NCT01540487|E2|Reported Event|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
155707|NCT01540487|E1|Reported Event|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
155708|NCT01540370|B1|Baseline|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
155709|NCT01540370|P1|Participant Flow|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
155710|NCT01540370|O1|Outcome|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
155711|NCT01540370|O1|Outcome|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
155712|NCT01540370|E1|Reported Event|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
155713|NCT01540266|B7|Baseline|Total|Total of all reporting groups
155714|NCT01540266|B6|Baseline|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
156132|NCT01537133|P1|Participant Flow|Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
155715|NCT01540266|B5|Baseline|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155716|NCT01540266|B4|Baseline|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155717|NCT01540266|B3|Baseline|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155718|NCT01540266|B2|Baseline|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155719|NCT01540266|B1|Baseline|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155720|NCT01540266|P6|Participant Flow|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155721|NCT01540266|P5|Participant Flow|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155722|NCT01540266|P4|Participant Flow|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155723|NCT01540266|P3|Participant Flow|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155724|NCT01540266|P2|Participant Flow|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155725|NCT01540266|P1|Participant Flow|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
156958|NCT01535365|O1|Outcome|Heat|Application of heat to site of muscle sprain.
155726|NCT01540266|O6|Outcome|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155727|NCT01540266|O5|Outcome|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155728|NCT01540266|O4|Outcome|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155729|NCT01540266|O3|Outcome|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155730|NCT01540266|O2|Outcome|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155731|NCT01540266|O1|Outcome|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155770|NCT01540045|O1|Outcome|> or = Umami Perception Thresholds|"peripheral neuropathy in patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.
(> UPT) = more sensibility to umami perception"
155732|NCT01540266|E6|Reported Event|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155733|NCT01540266|E5|Reported Event|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155734|NCT01540266|E4|Reported Event|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155735|NCT01540266|E3|Reported Event|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155736|NCT01540266|E2|Reported Event|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient
no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155737|NCT01540266|E1|Reported Event|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient
Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
155738|NCT01540162|B3|Baseline|Total|Total of all reporting groups
155739|NCT01540162|B2|Baseline|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
155740|NCT01540162|B1|Baseline|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
155741|NCT01540162|P2|Participant Flow|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
155742|NCT01540162|P1|Participant Flow|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
155743|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
155744|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
155745|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
155746|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
155747|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
155748|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
155749|NCT01540162|E2|Reported Event|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
155750|NCT01540162|E1|Reported Event|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
155751|NCT01540045|B1|Baseline|Pre-chemotherapy Patientes =40|Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
191308|NCT01405794|O1|Outcome|Placebo|
155752|NCT01540045|P1|Participant Flow|Pre-chemotherapy Patientes =40|Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
155753|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
155754|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
155755|NCT01540045|O2|Outcome|Post-chemotherapy Patients|patients with high or low sensibility to umami, bitter and sweet tastes post-chemotherapy
155756|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|patients with high or low sensibility to umami, bitter and sweet tastes pre-chemotherapy
155757|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
155758|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
155759|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
155760|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
155761|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
155762|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
155763|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
155764|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
155765|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
155766|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
155767|NCT01540045|O2|Outcome|> Umami Recognition Thresholds|quality of life scales in patient with more or the same sensibility to recognize the umami taste
155768|NCT01540045|O1|Outcome|< or = Umami Recognition Thresholds|quality of life scales in patient with more or the same sensibility to recognize the umami taste
155769|NCT01540045|O2|Outcome|< Umami Perception Thresholds|"peripheral neuropathy patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.
(< UPT) = less sensibility to umami perception"
156133|NCT01537133|O4|Outcome|Healthy Control|
155771|NCT01540045|O2|Outcome|< Umami Perception Thresholds|"patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.
(< UPT) = less sensibility to umami perception"
155772|NCT01540045|O1|Outcome|> or = Umami Perception Thresholds|"patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.
(> UPT) = more sensibility to umami perception"
155773|NCT01540045|O2|Outcome|HRQL Post-chemotherapy|Score of scale HRQL EORTC
155774|NCT01540045|O1|Outcome|HRQL Pre-chemotherapy|Score of scale HRQL EORTC
155775|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
155776|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
155777|NCT01540045|O2|Outcome|< Sweet Perception Thresholds After Chemotherapy|IRON CONSUMPTION < Sweet perception thresholds after chemotherapy
155778|NCT01540045|O1|Outcome|≥ Sweet Perception Thresholds After Chemotherapy|IRON CONSUMPTION ≥ Sweet perception thresholds after chemotherapy
155779|NCT01540045|O2|Outcome|< Sweet Perception Thresholds After Chemotherapy|patient with less sensibility to perceive sweet taste from food
155780|NCT01540045|O1|Outcome|≥ Sweet Perception Thresholds After Chemotherapy|patient with more sensibility to perceive sweet taste from food
155781|NCT01540045|O2|Outcome|Post-chemotherapy Patientes|Subjective Global Assessment post chemotherapy
155782|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|Subjective Global Assessment pre-chemotherapy
155783|NCT01540045|O2|Outcome|Post-chemotherapy Patients|body mass index post chemotherapy
155784|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|body mass index pre-chemotherapty
155785|NCT01540045|O2|Outcome|Post-chemotherapy Patients|body composition post chemotherapy
155786|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|body composition pre-chemotherapy
155787|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
155788|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
155789|NCT01540045|E1|Reported Event|LUNG CANCER PATIENTS|any toxicity resulting from exposure to chemotherapy with which patients are treated are unrelated to this study, which was observational
155790|NCT01539980|B1|Baseline|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
155791|NCT01539980|P1|Participant Flow|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
155792|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
155793|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
155794|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
155817|NCT01539759|E1|Reported Event|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
155795|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
155796|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
155797|NCT01539980|E1|Reported Event|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
155798|NCT01539811|B3|Baseline|Total|Total of all reporting groups
155799|NCT01539811|B2|Baseline|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)
Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot
Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
155800|NCT01539811|B1|Baseline|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)
Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot
Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
155801|NCT01539811|P2|Participant Flow|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)
Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot
Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
156134|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
156135|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
155802|NCT01539811|P1|Participant Flow|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)
Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot
Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
155803|NCT01539811|O2|Outcome|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)
Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot
Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
155804|NCT01539811|O1|Outcome|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)
Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot
Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
155805|NCT01539811|E2|Reported Event|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)
Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot
Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
155806|NCT01539811|E1|Reported Event|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)
Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot
Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
155807|NCT01539759|B3|Baseline|Total|Total of all reporting groups
155808|NCT01539759|B2|Baseline|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
155809|NCT01539759|B1|Baseline|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
155810|NCT01539759|P2|Participant Flow|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
155811|NCT01539759|P1|Participant Flow|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
155812|NCT01539759|O2|Outcome|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
155813|NCT01539759|O1|Outcome|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
155814|NCT01539759|O2|Outcome|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
155815|NCT01539759|O1|Outcome|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
155816|NCT01539759|E2|Reported Event|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
155818|NCT01539642|B3|Baseline|Total|Total of all reporting groups
155819|NCT01539642|B2|Baseline|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
155820|NCT01539642|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
155821|NCT01539642|P2|Participant Flow|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
155822|NCT01539642|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
155823|NCT01539642|O2|Outcome|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
155824|NCT01539642|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
155825|NCT01539642|E2|Reported Event|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
155826|NCT01539642|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
155827|NCT01539590|B3|Baseline|Total|Total of all reporting groups
155828|NCT01539590|B2|Baseline|Placebo|Normal saline. Daily intravenous administration for four (4) days.
155829|NCT01539590|B1|Baseline|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
156136|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
156137|NCT01537133|O4|Outcome|Healthy Control|
155830|NCT01539590|P2|Participant Flow|Placebo; 4 Daily Doses|Placebo: Normal saline; Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
155831|NCT01539590|P1|Participant Flow|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days ; 10 to 12 minutes; small molecule mimetic of hepatocyte growth factor
155832|NCT01539590|O2|Outcome|Placebo, 4 Daily Doses|Normal saline. Daily intravenous administration for four (4) days.
155833|NCT01539590|O1|Outcome|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
155834|NCT01539590|E2|Reported Event|Placebo|"Normal saline
Placebo: Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight."
155835|NCT01539590|E1|Reported Event|BB3 Small Molecule Mimetic of Hepatocyte Growth Factor|"small molecule mimetic of hepatocyte growth factor/scatter factor
BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days"
155836|NCT01539538|B3|Baseline|Total|Total of all reporting groups
155837|NCT01539538|B2|Baseline|Morphine IV PCA|
155838|NCT01539538|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|
155839|NCT01539538|P2|Participant Flow|Morphine IV PCA|
155840|NCT01539538|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|
155841|NCT01539538|O2|Outcome|Morphine IV PCA|
155842|NCT01539538|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|
155843|NCT01539538|E2|Reported Event|Morphine IV PCA|
155844|NCT01539538|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|
155845|NCT01539525|B4|Baseline|Total|Total of all reporting groups
155846|NCT01539525|B3|Baseline|Treatment as Usual|"No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
155847|NCT01539525|B2|Baseline|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155848|NCT01539525|B1|Baseline|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155849|NCT01539525|P3|Participant Flow|Treatment as Usual|"No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
155850|NCT01539525|P2|Participant Flow|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155851|NCT01539525|P1|Participant Flow|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155852|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.
Treatment as Usual: Subjects given a brochure listing relevant recovery resources in the local area."
155853|NCT01539525|O2|Outcome|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155854|NCT01539525|O1|Outcome|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155855|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
155856|NCT01539525|O2|Outcome|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155857|NCT01539525|O1|Outcome|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155858|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
155859|NCT01539525|O2|Outcome|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155860|NCT01539525|O1|Outcome|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155861|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
155862|NCT01539525|O2|Outcome|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155863|NCT01539525|O1|Outcome|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155864|NCT01539525|E3|Reported Event|Treatment as Usual|"No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
155865|NCT01539525|E2|Reported Event|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155866|NCT01539525|E1|Reported Event|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
155867|NCT01539512|B3|Baseline|Total|Total of all reporting groups
155868|NCT01539512|B2|Baseline|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155869|NCT01539512|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155870|NCT01539512|P2|Participant Flow|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155871|NCT01539512|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155872|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155873|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155874|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155875|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155876|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155877|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155878|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155879|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155880|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155881|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155882|NCT01539512|E2|Reported Event|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155883|NCT01539512|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
155884|NCT01539317|B3|Baseline|Total|Total of all reporting groups
155885|NCT01539317|B2|Baseline|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155886|NCT01539317|B1|Baseline|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155887|NCT01539317|P2|Participant Flow|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155888|NCT01539317|P1|Participant Flow|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155889|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155890|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155891|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155892|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155893|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155894|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155895|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155896|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155897|NCT01539317|O3|Outcome|Open Label|"During Open-label Lidocaine 8 weeks
Each prior arm converted to use of open label lidocaine for 2 further months."
155898|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule
Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness"
155899|NCT01539317|O1|Outcome|Topical Saline|"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule
Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness"
155900|NCT01539317|E2|Reported Event|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155901|NCT01539317|E1|Reported Event|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
155902|NCT01539135|B3|Baseline|Total|Total of all reporting groups
155903|NCT01539135|B2|Baseline|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155904|NCT01539135|B1|Baseline|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155905|NCT01539135|P2|Participant Flow|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
156138|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
155906|NCT01539135|P1|Participant Flow|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155907|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155908|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155909|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155910|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155911|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155912|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155913|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155914|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155915|NCT01539135|E2|Reported Event|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155916|NCT01539135|E1|Reported Event|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
155917|NCT01539083|B1|Baseline|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
155918|NCT01539083|P3|Participant Flow|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
155919|NCT01539083|P2|Participant Flow|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
156959|NCT01535365|O2|Outcome|Ice Pack|Application of cold to muscle sprain.
155920|NCT01539083|P1|Participant Flow|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
155921|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
155922|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
155923|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
155924|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
156139|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
155925|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
155926|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
155927|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
155928|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
155929|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
155930|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
155931|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
155932|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
155933|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
155934|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
155935|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
155936|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
155937|NCT01539083|E3|Reported Event|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
155970|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
155971|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
155938|NCT01539083|E2|Reported Event|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
155939|NCT01539083|E1|Reported Event|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
155940|NCT01539070|B3|Baseline|Total|Total of all reporting groups
155941|NCT01539070|B2|Baseline|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
155953|NCT01539070|E2|Reported Event|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
156140|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
155942|NCT01539070|B1|Baseline|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.
There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
155943|NCT01539070|P2|Participant Flow|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
155944|NCT01539070|P1|Participant Flow|Eating and Physical Activity Counseling|"Eating and physical activity counseling: The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.
There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
155945|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
155946|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.
There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
155947|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
155948|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.
There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
155949|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
155950|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.
There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
155972|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
155951|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
155952|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.
There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
156141|NCT01537133|O4|Outcome|Healthy Control|
155954|NCT01539070|E1|Reported Event|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.
There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
155955|NCT01538862|B1|Baseline|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days
Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
155956|NCT01538862|P1|Participant Flow|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days
Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
155957|NCT01538862|O1|Outcome|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days
Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
155958|NCT01538862|O1|Outcome|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d subcutaneously for 7 days
Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d subcutaneously for 7 days"
155959|NCT01538862|O1|Outcome|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d subcutaneously for 7 days
Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d subcutaneously for 7 days"
155960|NCT01538862|E1|Reported Event|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days
Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
155961|NCT01538472|B1|Baseline|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
155962|NCT01538472|P1|Participant Flow|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea (BCNU) (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
155963|NCT01538472|O1|Outcome|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
155964|NCT01538472|O1|Outcome|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
155965|NCT01538472|E1|Reported Event|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
155966|NCT01537900|B1|Baseline|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
155967|NCT01537900|P1|Participant Flow|Grazoprevir 100 mg|Participants received GZR 100 mg once daily (q.d.) for 7 days. Liver FNA was performed on Day 7.
155968|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
155969|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
191309|NCT01405794|O2|Outcome|32ppm Oral Silver|
155973|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
155974|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
155975|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
155976|NCT01537900|E1|Reported Event|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
155977|NCT01537835|B4|Baseline|Total|Total of all reporting groups
155978|NCT01537835|B3|Baseline|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
155979|NCT01537835|B2|Baseline|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
156142|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
155980|NCT01537835|B1|Baseline|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
155981|NCT01537835|P3|Participant Flow|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
155982|NCT01537835|P2|Participant Flow|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
155983|NCT01537835|P1|Participant Flow|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
155984|NCT01537835|O3|Outcome|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
155985|NCT01537835|O2|Outcome|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
155986|NCT01537835|O1|Outcome|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
155987|NCT01537835|O3|Outcome|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
155988|NCT01537835|O2|Outcome|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
155989|NCT01537835|O1|Outcome|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
155990|NCT01537835|E3|Reported Event|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
155991|NCT01537835|E2|Reported Event|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
155992|NCT01537835|E1|Reported Event|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
155993|NCT01537783|B3|Baseline|Total|Total of all reporting groups
155994|NCT01537783|B2|Baseline|Standard of Care|Standard emergency department care
155995|NCT01537783|B1|Baseline|Intervention Group|Standard emergency department care plus eradication protocol
155996|NCT01537783|P2|Participant Flow|Intervention|Usual emergency department care plus eradication protocol
155997|NCT01537783|P1|Participant Flow|Standard of Care|Usual emergency department care
156960|NCT01535365|O1|Outcome|Heat Pack|Application of Heat to site of muscle sprain.
155998|NCT01537783|O2|Outcome|Standard of Care|In this arm, patients receive routine care of their abscess, which may or may not include either topical or oral antibiotics, at the discretion of the treating clinician.
155999|NCT01537783|O1|Outcome|Intervention Group|"In this arm, patients are treated with chlorhexidine scrubs once a day for 5 days and mupirocin nasal ointment inserted to both nostrils twice a day for 5 days. Both treatments are begun 7 days after enrollment, or when the abscess has healed fully if it has not healed by day 7.
Chlorhexidine gluconate: Scrubs applied once a day for 5 days
Mupirocin: Nasal mupirocin applied topically to both nostrils twice a day for 5 days"
156000|NCT01537783|E2|Reported Event|Standard of Care|Standard emergency department care
156001|NCT01537783|E1|Reported Event|Intervention Group|Standard emergency department care plus eradication protocol
156002|NCT01537666|B5|Baseline|Total|Total of all reporting groups
156003|NCT01537666|B4|Baseline|AeroVanc 32 and 80 mg in CF Patients|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156004|NCT01537666|B3|Baseline|AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
156143|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
156144|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
156005|NCT01537666|B2|Baseline|AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
156006|NCT01537666|B1|Baseline|Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
156007|NCT01537666|P4|Participant Flow|AeroVanc 32 and 80 mg in CF Patients|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156008|NCT01537666|P3|Participant Flow|AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
156009|NCT01537666|P2|Participant Flow|AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
156010|NCT01537666|P1|Participant Flow|Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
156011|NCT01537666|O2|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
156012|NCT01537666|O1|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
156013|NCT01537666|O2|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
156014|NCT01537666|O1|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
156015|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
156016|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156017|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156018|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156019|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
156020|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156021|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156022|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156023|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
156024|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156025|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156026|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156027|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
156028|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156029|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156030|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156031|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
156032|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156033|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156034|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
156035|NCT01537666|O6|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
191310|NCT01405794|O1|Outcome|Placebo|
156036|NCT01537666|O5|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
156037|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|Single IV dose of Vancomycin 250 mg in Healthy Volunteers. Group comprised of 2 subjects from each of the AeroVanc in Healthy Volunteers groups.
156038|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|Single inhaled dose of 80 mg AeroVanc in health volunteers.
156039|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|Single inhaled dose of 32 mg AeroVanc in health volunteers.
156040|NCT01537666|O1|Outcome|AeroVanc 16 mg in Healthy Volunteers|Single inhaled dose of 16 mg AeroVanc in health volunteers.
156041|NCT01537666|E6|Reported Event|IV Vancomycin 250 mg in Healthy Volunteers|Comprised of 2 patients from each of the AeroVanc in Healthy Volunteer groups.
156042|NCT01537666|E5|Reported Event|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
156145|NCT01537133|E2|Reported Event|Placebo|Placebo fluticasone (one puff, twice a day)
156043|NCT01537666|E4|Reported Event|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
156044|NCT01537666|E3|Reported Event|AeroVanc 80 mg in Healthy Volunteers|Single inhaled dose of 80 mg AeroVanc in health volunteers.
156045|NCT01537666|E2|Reported Event|AeroVanc 32 mg in Healthy Volunteers|Single inhaled dose of 32 mg AeroVanc in health volunteers.
156046|NCT01537666|E1|Reported Event|AeroVanc 16 mg in Healthy Volunteers|Single inhaled dose of 16 mg AeroVanc in health volunteers.
156047|NCT01537549|B1|Baseline|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
156048|NCT01537549|P1|Participant Flow|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
156049|NCT01537549|O2|Outcome|Juvenon at 1 Month|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily (1 month)
156050|NCT01537549|O1|Outcome|Juvenon at Baseline|at Baseline, no drug taken yet
156051|NCT01537549|O1|Outcome|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
156052|NCT01537549|E1|Reported Event|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
156053|NCT01537432|B3|Baseline|Total|Total of all reporting groups
156054|NCT01537432|B2|Baseline|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
156055|NCT01537432|B1|Baseline|AIN457 300mg|AIN457 300mg subcutaneously weekly
156056|NCT01537432|P2|Participant Flow|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
156057|NCT01537432|P1|Participant Flow|AIN457 300mg|AIN457 300mg subcutaneously weekly
156058|NCT01537432|O2|Outcome|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
156059|NCT01537432|O1|Outcome|AIN457 300mg|AIN457 300mg subcutaneously weekly
156060|NCT01537432|O2|Outcome|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
156061|NCT01537432|O1|Outcome|AIN457 300mg|AIN457 300mg subcutaneously weekly
156062|NCT01537432|E2|Reported Event|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
156063|NCT01537432|E1|Reported Event|AIN457 300 mg|AIN457 300mg subcutaneously weekly
156064|NCT01537367|B4|Baseline|Total|Total of all reporting groups
156065|NCT01537367|B3|Baseline|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
156066|NCT01537367|B2|Baseline|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
156067|NCT01537367|B1|Baseline|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient related to making and seeing clinic appointments.
156068|NCT01537367|P3|Participant Flow|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
156069|NCT01537367|P2|Participant Flow|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
156121|NCT01537185|E3|Reported Event|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
156269|NCT01536886|P2|Participant Flow|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
156070|NCT01537367|P1|Participant Flow|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
156071|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
156089|NCT01537315|O1|Outcome|Matching Placebo|"Patients with cardiovascular disease (CVD) and chronic kidney disease (CKD) will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)
Placebo comparator: matching placebo capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
156604|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
156072|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
156073|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
156074|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
156075|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
156076|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
156077|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
156078|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
156079|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
156080|NCT01537367|E3|Reported Event|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
156081|NCT01537367|E2|Reported Event|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
156082|NCT01537367|E1|Reported Event|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
156083|NCT01537315|B3|Baseline|Total|Total of all reporting groups
156084|NCT01537315|B2|Baseline|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)
Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
156085|NCT01537315|B1|Baseline|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)
Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
156086|NCT01537315|P2|Participant Flow|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)
Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
191311|NCT01405794|O2|Outcome|32ppm Oral Silver|
156087|NCT01537315|P1|Participant Flow|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)
Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
156088|NCT01537315|O2|Outcome|Hydroxychloroquine|"Patients with cardiovascular disease (CVD) and chronic kidney disease (CKD) will be randomized to either hydroxychloroquine (HCQ) or matching placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)
Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
156605|NCT01536366|E2|Reported Event|Repaglinide|Repaglinide 0.5 mg
156090|NCT01537315|E2|Reported Event|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)
Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
156091|NCT01537315|E1|Reported Event|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)
Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
156092|NCT01537302|B1|Baseline|Ocelot|CTO crossing in femoropopliteal arteries using the Ocelot System
156093|NCT01537302|P1|Participant Flow|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
156094|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
156095|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
156096|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
156097|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
156098|NCT01537302|E1|Reported Event|Treatment Arm|CTO crossing in femoropopliteal arteries CONNECT II: CTO crossing in femoropopliteal arteries using the Ocelot System
156099|NCT01537198|B1|Baseline|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
156100|NCT01537198|P1|Participant Flow|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
156101|NCT01537198|O1|Outcome|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
156102|NCT01537198|E1|Reported Event|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
156103|NCT01537185|B5|Baseline|Total|Total of all reporting groups
156104|NCT01537185|B4|Baseline|Cohort 3 SPWCV+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
156105|NCT01537185|B3|Baseline|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
156106|NCT01537185|B2|Baseline|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection"
156107|NCT01537185|B1|Baseline|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
156108|NCT01537185|P4|Participant Flow|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
156109|NCT01537185|P3|Participant Flow|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
156110|NCT01537185|P2|Participant Flow|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection"
156111|NCT01537185|P1|Participant Flow|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
156112|NCT01537185|O4|Outcome|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
156113|NCT01537185|O3|Outcome|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
156114|NCT01537185|O2|Outcome|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection"
156115|NCT01537185|O1|Outcome|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
156116|NCT01537185|O4|Outcome|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
156117|NCT01537185|O3|Outcome|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
156118|NCT01537185|O2|Outcome|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection"
156119|NCT01537185|O1|Outcome|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
156120|NCT01537185|E4|Reported Event|Cohort 3 SPWCV+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
156961|NCT01535365|E2|Reported Event|Cold|Application of cold to muscle sprain.
156122|NCT01537185|E2|Reported Event|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection"
156123|NCT01537185|E1|Reported Event|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
156124|NCT01537133|B5|Baseline|Total|Total of all reporting groups
156125|NCT01537133|B4|Baseline|Healthy Control|
156126|NCT01537133|B3|Baseline|Atopic Non-asthmatics|
156127|NCT01537133|B2|Baseline|Atopic Asthmatics Treated With Placebo|Placebo fluticasone (one puff, twice a day)
156128|NCT01537133|B1|Baseline|Atopic Asthmatics Treated With Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
156129|NCT01537133|P4|Participant Flow|Atopic Non-asthmatics|
156130|NCT01537133|P3|Participant Flow|Healthy Control|
156131|NCT01537133|P2|Participant Flow|Placebo|Placebo fluticasone (one puff, twice a day)
156146|NCT01537133|E1|Reported Event|Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
156147|NCT01537120|B1|Baseline|Placebo → Vildagliptin|Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
156148|NCT01537120|P1|Participant Flow|Placebo → Vildagliptin|Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
156149|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
156150|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
156151|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
156152|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
156153|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
156154|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
156155|NCT01537120|E2|Reported Event|Placebo|Placebo tablets twice daily for 3 weeks
156156|NCT01537120|E1|Reported Event|Vildagliptin 50 mg|Vildagliptin tablets 50 mg twice daily for 12 weeks
156157|NCT01537081|B4|Baseline|Total|Total of all reporting groups
156158|NCT01537081|B3|Baseline|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
156159|NCT01537081|B2|Baseline|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
156160|NCT01537081|B1|Baseline|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
156161|NCT01537081|P3|Participant Flow|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
156162|NCT01537081|P2|Participant Flow|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
156163|NCT01537081|P1|Participant Flow|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex (600-mg) tablets and 1 placebo tablet matching the 200-mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
156164|NCT01537081|O3|Outcome|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
156165|NCT01537081|O2|Outcome|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
156193|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156194|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
191312|NCT01405794|O1|Outcome|Placebo|
156166|NCT01537081|O1|Outcome|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex (600-mg) tablets and 1 placebo tablet matching the 200-mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
156167|NCT01537081|O3|Outcome|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
156168|NCT01537081|O2|Outcome|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
156169|NCT01537081|O1|Outcome|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
156170|NCT01537081|E3|Reported Event|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
156171|NCT01537081|E2|Reported Event|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
156172|NCT01537081|E1|Reported Event|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
156173|NCT01537042|B3|Baseline|Total|Total of all reporting groups
156174|NCT01537042|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156175|NCT01537042|B1|Baseline|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156176|NCT01537042|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.
Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal."
156177|NCT01537042|P1|Participant Flow|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance.
Up to 3 weeks of Titration,
2 weeks of Maintenance,
Up to 4 days of Taper Period."
156178|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156179|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156180|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156181|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156182|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156183|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156184|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156185|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156186|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156187|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156188|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156189|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156190|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156191|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156192|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156268|NCT01536886|P3|Participant Flow|LEO 90100 Vehicle|Aerosol foam with no active ingredients
156195|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156196|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156197|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156198|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156199|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156200|NCT01537042|O4|Outcome|Rotigotine (Visit 6)|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156201|NCT01537042|O3|Outcome|Placebo (Visit 6)|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156202|NCT01537042|O2|Outcome|Rotigotine (Visit 2)|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156203|NCT01537042|O1|Outcome|Placebo (Visit 2)|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156204|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156205|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156606|NCT01536366|E1|Reported Event|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
156206|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156207|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156208|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156209|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156210|NCT01537042|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
156211|NCT01537042|E1|Reported Event|Placebo|"Transdermal patch matched according to patch size and appearance.
Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
156212|NCT01536951|B3|Baseline|Total|Total of all reporting groups
156213|NCT01536951|B2|Baseline|Part B (LY3009104, Moxifloxacin, or Placebo)|Participants were randomized to 1 of 6 treatment sequences during Part B of the study and received a single dose (LY3009104, moxifloxacin, or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as a 40-mg dose. Moxifloxacin was administered as a 400-mg tablet.
156214|NCT01536951|B1|Baseline|Part A (LY3009104 or Placebo)|Participants were randomized to 1 of 3 treatment sequences during Part A of the study and received a single dose (LY3009104 or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as either 20-milligrams (mg), 30-mg or 40-mg dose.
156215|NCT01536951|P9|Participant Flow|Part B: Placebo, 40 mg LY3009104, Moxifloxacin|"First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Second Intervention: 40-mg LY3009104 dose administered orally once.
Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.
There was a washout of at least 3 days between each intervention."
156216|NCT01536951|P8|Participant Flow|Part B: 40 mg LY3009104, Moxifloxacin, Placebo|"First Intervention: 40-mg LY3009104 dose administered orally once.
Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
There was a washout of at least 3 days between each intervention."
156217|NCT01536951|P7|Participant Flow|Part B: Moxifloxacin, Placebo, 40 mg LY3009104|"First Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention."
156218|NCT01536951|P6|Participant Flow|Part B: Moxifloxacin, 40 mg LY3009104, Placebo|"First Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Second Intervention: 40-mg LY3009104 dose administered orally once.
Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
There was a washout of at least 3 days between each intervention."
156219|NCT01536951|P5|Participant Flow|Part B: Placebo, Moxifloxacin, 40 mg LY3009104|"First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention."
156220|NCT01536951|P4|Participant Flow|Part B: 40 mg LY3009104, Placebo, Moxifloxacin|"First Intervention: 40-mg LY3009104 dose administered orally once.
Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.
There was a washout of at least 3 days between each intervention."
156221|NCT01536951|P3|Participant Flow|Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104|"First Intervention: 20-mg LY3009104 dose administered orally once.
Second Intervention: Placebo tablets (matching 30-mg LY3009104) administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention."
156222|NCT01536951|P2|Participant Flow|Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo|"First Intervention: 20-mg LY3009104 dose administered orally once.
Second Intervention: 30-mg LY3009104 dose administered orally once.
Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.
There was a washout of at least 3 days between each intervention."
156962|NCT01535365|E1|Reported Event|Heat|Application of Heat to site of muscle sprain.
156223|NCT01536951|P1|Participant Flow|Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104|"First Intervention: Placebo tablets [matching 20-mg LY3009104] administered orally once.
Second Intervention: 30-mg LY3009104 dose administered orally once.
Third Intervention: 40-mg LY3009104 dose administered orally once.
There was a washout of at least 3 days between each intervention."
156224|NCT01536951|O7|Outcome|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
156225|NCT01536951|O6|Outcome|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
156226|NCT01536951|O5|Outcome|Part B: Placebo|Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
156227|NCT01536951|O4|Outcome|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
156228|NCT01536951|O3|Outcome|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
156229|NCT01536951|O2|Outcome|Part A: 20 mg LY3009104|A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.
156230|NCT01536951|O1|Outcome|Part A: Placebo|Placebo tablets [matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104] administered orally once in any period during Part A of the study.
156231|NCT01536951|O4|Outcome|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
156232|NCT01536951|O3|Outcome|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
156233|NCT01536951|O2|Outcome|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
156234|NCT01536951|O1|Outcome|Part A: 20 mg LY3009104|A 20-milligram (mg) LY3009104 dose administered orally once in Part A, Period 1 of the study.
156607|NCT01536262|B4|Baseline|Total|Total of all reporting groups
156235|NCT01536951|O4|Outcome|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
156236|NCT01536951|O3|Outcome|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
156237|NCT01536951|O2|Outcome|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
156238|NCT01536951|O1|Outcome|Part A: 20 mg LY3009104|A 20-milligram (mg) LY3009104 dose administered orally once in Part A, Period 1 of the study.
156239|NCT01536951|O3|Outcome|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
156240|NCT01536951|O2|Outcome|Part B: 40 mg LY3009104|A 40-milligram (mg) dose of LY3009104 administered orally once in any period during Part B of the study.
156241|NCT01536951|O1|Outcome|Part B: Placebo|Placebo tablets (matching LY3009104) administered orally once in any period during Part B of the study.
156242|NCT01536951|E7|Reported Event|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
156243|NCT01536951|E6|Reported Event|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
156244|NCT01536951|E5|Reported Event|Part B: Placebo|Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
156245|NCT01536951|E4|Reported Event|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
156246|NCT01536951|E3|Reported Event|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
156247|NCT01536951|E2|Reported Event|Part A: 20 mg LY3009104|A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.
156248|NCT01536951|E1|Reported Event|Part A: Placebo|Placebo tablets [matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104] administered orally once in any period during Part A of the study.
156249|NCT01536938|B4|Baseline|Total|Total of all reporting groups
156250|NCT01536938|B3|Baseline|Calcipotriol Aerosol Foam|Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
156251|NCT01536938|B2|Baseline|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
156252|NCT01536938|B1|Baseline|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
156253|NCT01536938|P3|Participant Flow|Calcipotriol Aerosol Foam|"Calcipotriol aerosol foam: calcipotriol 50 mcg/g.
Applied once daily for up to 4 weeks"
156254|NCT01536938|P2|Participant Flow|Betamethasone Dipropionate|"Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate)
Applied once daily for up to 4 weeks"
156255|NCT01536938|P1|Participant Flow|LEO 90100|"LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
Applied once daily for up to 4 weeks"
156256|NCT01536938|O3|Outcome|Calcipotriol Aerosol Foam|Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
156257|NCT01536938|O2|Outcome|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
156258|NCT01536938|O1|Outcome|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
156259|NCT01536938|E3|Reported Event|Calcipotriol Aerosol Foam|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
156260|NCT01536938|E2|Reported Event|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
156261|NCT01536938|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
156262|NCT01536886|B5|Baseline|Total|Total of all reporting groups
156263|NCT01536886|B4|Baseline|Ointment Vehicle|Ointment with no active ingredients
156264|NCT01536886|B3|Baseline|LEO 90100 Vehicle|Aerosol foam with no active ingredients
156265|NCT01536886|B2|Baseline|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
156266|NCT01536886|B1|Baseline|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
156267|NCT01536886|P4|Participant Flow|Ointment Vehicle|Ointment with no active ingredients
156270|NCT01536886|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
156271|NCT01536886|O4|Outcome|Ointment Vehicle|Ointment with no active ingredients
156272|NCT01536886|O3|Outcome|LEO 90100 Vehicle|Aerosol foam with no active ingredients
156273|NCT01536886|O2|Outcome|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
156274|NCT01536886|O1|Outcome|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
156275|NCT01536886|E4|Reported Event|Ointment Vehicle|Ointment with no active ingredients
156276|NCT01536886|E3|Reported Event|LEO 90100 Vehicle|Aerosol foam with no active ingredients
156277|NCT01536886|E2|Reported Event|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
156278|NCT01536886|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
156279|NCT01536860|B1|Baseline|Entire Study Population|Includes groups randomized to receive Control Test Drink first, Exp Test Drink 1 first and Exp Test Drink 2 first.
156280|NCT01536860|P3|Participant Flow|Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1|"Consume Exp Test Drink 2 once over a 15 minute period followed by a 3 day wash out period.
Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.
Consume Exp Test Drink 1 once over a 15 minute period."
156281|NCT01536860|P2|Participant Flow|Exp Test Drink 1/Control Test Drink/Exp Test Drink 2|"Consume Exp Test Drink 1 once over a 15 minute period followed by a 3 day wash out period.
Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.
Consume Exp Test Drink 2 once over a 15 minute period."
157191|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
156282|NCT01536860|P1|Participant Flow|Control Test Drink/Exp Test Drink 1/Exp Test Drink 2|"Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.
Consume Exp Test Drink 1 followed by a 3 day wash out period. Consume Exp Test Drink 2 over a 15 minute period"
156283|NCT01536860|O3|Outcome|Experimental Test Drink 2|"Control Drink containing ingredient 2
Dietary Intervention : 300 ml of liquid food product"
156284|NCT01536860|O2|Outcome|Experimental Test Drink 1|"Control Drink containing ingredient 1
Dietary Intervention : 300 ml of liquid food product"
156285|NCT01536860|O1|Outcome|Control Test Drink|"Control Drink
Dietary Intervention : 300 ml of liquid food product"
156286|NCT01536860|E3|Reported Event|Experimental Test Drink 2|"Control Drink containing ingredient 2
Dietary Intervention : 300 ml of liquid food product"
156287|NCT01536860|E2|Reported Event|Experimental Test Drink 1|"Control Drink containing ingredient 1
Dietary Intervention : 300 ml of liquid food product"
156288|NCT01536860|E1|Reported Event|Control Test Drink|"Control Drink
Dietary Intervention : 300 ml of liquid food product"
156289|NCT01536704|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures
156290|NCT01536704|P4|Participant Flow|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156291|NCT01536704|P3|Participant Flow|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156292|NCT01536704|P2|Participant Flow|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156293|NCT01536704|P1|Participant Flow|2 Milligram (mg) Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156294|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156295|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156296|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156297|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156298|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156299|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156300|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156301|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156302|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156303|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156304|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156305|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156306|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156963|NCT01535326|B4|Baseline|Total|Total of all reporting groups
156307|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156308|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156309|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156310|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156311|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156312|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156313|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156314|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156354|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156315|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156316|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156317|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156318|NCT01536704|E4|Reported Event|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156319|NCT01536704|E3|Reported Event|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
156320|NCT01536704|E2|Reported Event|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156321|NCT01536704|E1|Reported Event|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
156322|NCT01536587|B1|Baseline|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156323|NCT01536587|P1|Participant Flow|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156324|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156325|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156326|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156327|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156328|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156329|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156330|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156331|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156332|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156333|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156334|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156335|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156336|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156337|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156338|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156339|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156340|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156341|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156342|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156343|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156344|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156345|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156346|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156347|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156348|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156349|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156350|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156351|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156352|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156353|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156355|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156356|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156357|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156358|NCT01536587|E1|Reported Event|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
156359|NCT01536574|B3|Baseline|Total|Total of all reporting groups
156360|NCT01536574|B2|Baseline|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156361|NCT01536574|B1|Baseline|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156362|NCT01536574|P2|Participant Flow|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156363|NCT01536574|P1|Participant Flow|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156364|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156482|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
157012|NCT01535222|B2|Baseline|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
156365|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156366|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156608|NCT01536262|B3|Baseline|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156367|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156368|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156369|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156370|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156371|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156372|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156483|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156484|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
157013|NCT01535222|B1|Baseline|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
156373|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156374|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156375|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156376|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156377|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156378|NCT01536574|E2|Reported Event|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156379|NCT01536574|E1|Reported Event|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
156380|NCT01536561|B1|Baseline|TST and Iodine I 131 TST|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156485|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156486|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156381|NCT01536561|P1|Participant Flow|TST and Iodine I 131 TST|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156517|NCT01536379|B1|Baseline|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156518|NCT01536379|P2|Participant Flow|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156382|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156383|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156384|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156385|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156386|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156387|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156487|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156488|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156489|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156388|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156389|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156390|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156391|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156392|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156393|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156394|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156490|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156491|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
157014|NCT01535222|P6|Participant Flow|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
156395|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156396|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156397|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156398|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156399|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156400|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156401|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156492|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156493|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156494|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156402|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156403|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156404|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156405|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156406|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156407|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156408|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156495|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156496|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156497|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156409|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
156410|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156411|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156412|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156413|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156414|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study."
156415|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156498|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156499|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156500|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156426|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156416|NCT01536561|E2|Reported Event|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:&gt;=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study."
156417|NCT01536561|E1|Reported Event|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
156418|NCT01536496|B3|Baseline|Total|Total of all reporting groups
156419|NCT01536496|B2|Baseline|Test (r-TEG)|
156420|NCT01536496|B1|Baseline|Control (INR, PTT, Fibrinogen, D-dimer)|
156421|NCT01536496|P2|Participant Flow|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156422|NCT01536496|P1|Participant Flow|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156423|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156424|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156425|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156501|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
157015|NCT01535222|P5|Participant Flow|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
156427|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156428|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156429|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156430|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156431|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156432|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156502|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156503|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156504|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
191313|NCT01405794|O2|Outcome|32ppm Oral Silver|
156433|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156434|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156435|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156436|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156437|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156438|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156439|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156505|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156506|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156507|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
157168|NCT01534533|B1|Baseline|Placebo|starch in hard shell gelatine capsules
156440|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156441|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156442|NCT01536496|O1|Outcome|Control (INR, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156443|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156444|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156445|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156446|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156508|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156509|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156510|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
157169|NCT01534533|P4|Participant Flow|Normal Lutein Group|subjects without early atherosclerosis
156514|NCT01536405|E1|Reported Event|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156515|NCT01536379|B3|Baseline|Total|Total of all reporting groups
156516|NCT01536379|B2|Baseline|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156594|NCT01536366|B1|Baseline|Group 1|"Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide
BIA 9-1067: 25 mg BIA 9-1067 (single-dose)
Repaglinide: 0.5 mg repaglinide (single-dose)"
156447|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156448|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156449|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156450|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156451|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156452|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156453|NCT01536496|E2|Reported Event|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
156511|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156512|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156513|NCT01536405|E2|Reported Event|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
191314|NCT01405794|O1|Outcome|Placebo|
156454|NCT01536496|E1|Reported Event|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
156455|NCT01536418|B3|Baseline|Total|Total of all reporting groups
156456|NCT01536418|B2|Baseline|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
156457|NCT01536418|B1|Baseline|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
156458|NCT01536418|P2|Participant Flow|GSK1605786A, 500 mg Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
156459|NCT01536418|P1|Participant Flow|GSK1605786A, 500 Milligram (mg), Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
156460|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
156461|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
156462|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
156463|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
156464|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
156465|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
156466|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
156467|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
156468|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
156469|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
156470|NCT01536418|O2|Outcome|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
156471|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
156472|NCT01536418|O2|Outcome|GSK1605786A 500 mg,Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
156473|NCT01536418|O1|Outcome|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
156474|NCT01536418|E2|Reported Event|GSK1605786A 500 mg, Twice Daily|Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
156475|NCT01536418|E1|Reported Event|GSK1605786A 500 mg, Once Daily|Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
156476|NCT01536405|B3|Baseline|Total|Total of all reporting groups
156477|NCT01536405|B2|Baseline|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156478|NCT01536405|B1|Baseline|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156479|NCT01536405|P2|Participant Flow|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
156480|NCT01536405|P1|Participant Flow|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
156481|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
191315|NCT01405794|O2|Outcome|32ppm Oral Silver|
156519|NCT01536379|P1|Participant Flow|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156520|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156521|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156522|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156523|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156524|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156525|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156526|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156527|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156528|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156529|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156530|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156531|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156532|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156533|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
157016|NCT01535222|P4|Participant Flow|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
156534|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156535|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156536|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156595|NCT01536366|P2|Participant Flow|Group 2|"Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide
BIA 9-1067: 25 mg BIA 9-1067 (single-dose)
Repaglinide: 0.5 mg repaglinide (single-dose)"
157192|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
156537|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156538|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156539|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156540|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156541|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156542|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156543|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156544|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156545|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156546|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156547|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156548|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156549|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156550|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156551|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156552|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
191316|NCT01405794|O1|Outcome|Placebo|
156553|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156554|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156555|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156556|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156557|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156558|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156559|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156560|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156561|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156562|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156563|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156564|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156565|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156566|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156567|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156568|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156569|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156570|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156571|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
157170|NCT01534533|P3|Participant Flow|Lutein and Lycopene Group|lutein plus lycopene group
156572|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156573|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156596|NCT01536366|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide
BIA 9-1067: 25 mg BIA 9-1067 (single-dose)
Repaglinide: 0.5 mg repaglinide (single-dose)"
156597|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
156574|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156575|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156576|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156577|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156578|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156579|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156580|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156581|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156582|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156583|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156584|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156585|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156586|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156587|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156588|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156589|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156590|NCT01536379|E2|Reported Event|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156591|NCT01536379|E1|Reported Event|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
156592|NCT01536366|B3|Baseline|Total|Total of all reporting groups
156593|NCT01536366|B2|Baseline|Group 2|"Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide
BIA 9-1067: 25 mg BIA 9-1067 (single-dose)
Repaglinide: 0.5 mg repaglinide (single-dose)"
156598|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
156599|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
156609|NCT01536262|B2|Baseline|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156610|NCT01536262|B1|Baseline|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156611|NCT01536262|P3|Participant Flow|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156612|NCT01536262|P2|Participant Flow|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156613|NCT01536262|P1|Participant Flow|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156614|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156615|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156616|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156617|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156618|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156619|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156620|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156621|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156622|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156623|NCT01536262|E3|Reported Event|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156624|NCT01536262|E2|Reported Event|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156625|NCT01536262|E1|Reported Event|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
156626|NCT01536197|B3|Baseline|Total|Total of all reporting groups
156627|NCT01536197|B2|Baseline|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery
Gastric banding: Laparoscopic adjustable gastric banding"
156628|NCT01536197|B1|Baseline|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery
Gastric bypass: Roux-en-Y gastric bypass"
156629|NCT01536197|P2|Participant Flow|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery
Gastric banding: Laparoscopic adjustable gastric banding"
156630|NCT01536197|P1|Participant Flow|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery
Gastric bypass: Roux-en-Y gastric bypass"
156631|NCT01536197|O2|Outcome|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery
Gastric banding: Laparoscopic adjustable gastric banding"
156632|NCT01536197|O1|Outcome|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery
Gastric bypass: Roux-en-Y gastric bypass"
157171|NCT01534533|P2|Participant Flow|Lutein Group|20mg lutein per day
156633|NCT01536197|O2|Outcome|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery
Gastric banding: Laparoscopic adjustable gastric banding"
156634|NCT01536197|O1|Outcome|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery
Gastric bypass: Roux-en-Y gastric bypass"
156635|NCT01536197|E2|Reported Event|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery
Gastric banding: Laparoscopic adjustable gastric banding"
156636|NCT01536197|E1|Reported Event|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery
Gastric bypass: Roux-en-Y gastric bypass"
156637|NCT01536184|B3|Baseline|Total|Total of all reporting groups
156638|NCT01536184|B2|Baseline|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
156639|NCT01536184|B1|Baseline|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.
Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
156640|NCT01536184|P2|Participant Flow|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
156652|NCT01536184|E2|Reported Event|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
156641|NCT01536184|P1|Participant Flow|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.
Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
156642|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
156643|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.
Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
156644|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
156645|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.
Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
156646|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
156647|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.
Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
156648|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
156698|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156649|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.
Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
156650|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
156651|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.
Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
156653|NCT01536184|E1|Reported Event|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.
Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
156654|NCT01536171|B1|Baseline|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
156655|NCT01536171|P1|Participant Flow|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
156656|NCT01536171|O1|Outcome|Mid-Forefoot Striking in Shod Versus Barefoot Runners|two running conditions, with normal running shoes and barefoot
156657|NCT01536171|O1|Outcome|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
156658|NCT01536171|E1|Reported Event|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
156659|NCT01536145|B1|Baseline|CP-751,871|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156660|NCT01536145|P11|Participant Flow|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156661|NCT01536145|P10|Participant Flow|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156662|NCT01536145|P9|Participant Flow|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156663|NCT01536145|P8|Participant Flow|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156664|NCT01536145|P7|Participant Flow|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156665|NCT01536145|P6|Participant Flow|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156666|NCT01536145|P5|Participant Flow|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156667|NCT01536145|P4|Participant Flow|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156668|NCT01536145|P3|Participant Flow|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156669|NCT01536145|P2|Participant Flow|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
157172|NCT01534533|P1|Participant Flow|Placebo|starch in hard shell gelatine capsules
156670|NCT01536145|P1|Participant Flow|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156671|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156672|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156673|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156674|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156675|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156676|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156677|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156678|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
157033|NCT01535222|E5|Reported Event|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
156679|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156680|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156681|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156682|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156683|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156684|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156685|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156686|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156687|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156688|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156689|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156690|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156691|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156692|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156693|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156694|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156695|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156696|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156697|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156699|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156700|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156701|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156702|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156703|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156704|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156705|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156706|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156707|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156708|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156709|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156710|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156711|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156712|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156713|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156714|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156715|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156716|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156717|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156718|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156719|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156720|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156721|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156722|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156723|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156724|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156725|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156726|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156727|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156728|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156729|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156730|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156731|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156732|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156733|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156734|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156735|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156736|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156737|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156738|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156739|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156740|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156741|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156742|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156743|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156744|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156745|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156746|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156747|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156748|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156749|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156750|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156751|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156752|NCT01536145|O9|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156753|NCT01536145|O8|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156754|NCT01536145|O7|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156755|NCT01536145|O6|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156756|NCT01536145|O5|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156787|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156757|NCT01536145|O4|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156758|NCT01536145|O3|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156759|NCT01536145|O2|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156760|NCT01536145|O1|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156761|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156762|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156763|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156764|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
156765|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156766|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156767|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156768|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156769|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156770|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156771|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
156772|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
156773|NCT01536145|E1|Reported Event|CP-751,871|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks) (adverse events from all dosing groups were combined as a whole)
156774|NCT01536119|B3|Baseline|Total|Total of all reporting groups
156775|NCT01536119|B2|Baseline|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156776|NCT01536119|B1|Baseline|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156777|NCT01536119|P2|Participant Flow|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156778|NCT01536119|P1|Participant Flow|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156779|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156780|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156781|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156782|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156783|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156784|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156785|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156786|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156788|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156789|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156790|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156791|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156792|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156793|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156794|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156795|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156796|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156797|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156798|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156799|NCT01536119|E2|Reported Event|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
156800|NCT01536119|E1|Reported Event|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
156801|NCT01536093|B3|Baseline|Total|Total of all reporting groups
156802|NCT01536093|B2|Baseline|Placebo|"oropharyngeal administration of sterile water
oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156803|NCT01536093|B1|Baseline|Colostrum|"oropharyngeal administration of own mother's colostrum
oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156804|NCT01536093|P2|Participant Flow|Placebo|"oropharyngeal administration of sterile water
oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156805|NCT01536093|P1|Participant Flow|Colostrum|"oropharyngeal administration of own mother's colostrum
oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156806|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water
oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156807|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum
oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156808|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water
oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156809|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum
oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156810|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water
oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156811|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum
oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156812|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water
oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156813|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum
oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156814|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water
oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156815|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum
oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156816|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water
oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156953|NCT01535365|B2|Baseline|Cold|Application of cold to muscle sprain.
156954|NCT01535365|B1|Baseline|Heat|Application of Heat to site of muscle sprain.
156817|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum
oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156818|NCT01536093|E2|Reported Event|Placebo|"oropharyngeal administration of sterile water
oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156819|NCT01536093|E1|Reported Event|Colostrum|"oropharyngeal administration of own mother's colostrum
oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
156820|NCT01536067|B1|Baseline|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies"
156832|NCT01536015|B2|Baseline|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks"
156833|NCT01536015|B1|Baseline|Placebo|"Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks"
157034|NCT01535222|E4|Reported Event|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
156821|NCT01536067|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies"
156822|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies"
156823|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies"
156824|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies"
156825|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies"
156826|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies"
156827|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies"
156828|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies"
156829|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies"
156830|NCT01536067|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given SC
laboratory biomarker analysis: Correlative studies"
156831|NCT01536015|B3|Baseline|Total|Total of all reporting groups
156834|NCT01536015|P2|Participant Flow|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks"
156835|NCT01536015|P1|Participant Flow|Placebo|"Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks"
156836|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks"
156837|NCT01536015|O1|Outcome|Placebo|"Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks"
156838|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks"
156839|NCT01536015|O1|Outcome|Placebo|"Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks"
156840|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks"
156841|NCT01536015|O1|Outcome|Placebo|"Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks"
156842|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks"
156843|NCT01536015|O1|Outcome|Placebo|"Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks"
156844|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks"
156845|NCT01536015|O1|Outcome|Placebo|"Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks"
156846|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks"
156847|NCT01536015|O1|Outcome|Placebo|"Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks"
156848|NCT01536015|E2|Reported Event|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.
Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
Dosage and Frequency: One patch every 24 hours
Duration: 10 weeks"
156849|NCT01536015|E1|Reported Event|Placebo|"Placebo patch
Placebo: Frequency: One patch applied every 24 hours
Duration: 10 weeks"
156850|NCT01535976|B3|Baseline|Total|Total of all reporting groups
156851|NCT01535976|B2|Baseline|Placebo|"normal saline infusion
Placebo : Placebo Comparator: Placebo
normal saline infusion along with propofol 100 mcg/kg/min"
156852|NCT01535976|B1|Baseline|Ketamine|"Infusion of ketamine
Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min"
156853|NCT01535976|P2|Participant Flow|Placebo|".9 normal saline infusion
Placebo : Placebo Comparator: Placebo
.9 normal saline infusion"
156854|NCT01535976|P1|Participant Flow|Ketamine|"Infusion of ketamine
Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case"
156855|NCT01535976|O2|Outcome|Placebo|"normal saline infusion
Placebo : Placebo Comparator: Placebo
normal saline infusion along with propofol 100 mcg/kg/min"
156856|NCT01535976|O1|Outcome|Ketamine|"Infusion of ketamine
Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min."
156857|NCT01535976|E2|Reported Event|Placebo|".9 normal saline infusion
Placebo : Placebo Comparator: Placebo
.9 normal saline infusion"
156858|NCT01535976|E1|Reported Event|Ketamine|"Infusion of ketamine
Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case"
156859|NCT01535807|B3|Baseline|Total|Total of all reporting groups
156860|NCT01535807|B2|Baseline|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
156955|NCT01535365|P2|Participant Flow|Cold|Application of cold to muscle sprain.
156861|NCT01535807|B1|Baseline|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.
CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.
- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
156862|NCT01535807|P2|Participant Flow|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
156863|NCT01535807|P1|Participant Flow|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.
CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.
- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
156864|NCT01535807|O2|Outcome|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
156865|NCT01535807|O1|Outcome|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.
CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.
- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
156866|NCT01535807|E2|Reported Event|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
156867|NCT01535807|E1|Reported Event|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.
CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.
- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
156868|NCT01535729|B1|Baseline|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156869|NCT01535729|P1|Participant Flow|Non-small Cell Lung Cancer (NSCLC) Elderly Participants|Elderly Participants (greater than or equal to [≥] 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156870|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156871|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156872|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156873|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156874|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156875|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156876|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156877|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156878|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156879|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156880|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156881|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156882|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156883|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156884|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156885|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156886|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156887|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156888|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156889|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156890|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
157032|NCT01535222|E6|Reported Event|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
156891|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156892|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156893|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156894|NCT01535729|E1|Reported Event|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
156895|NCT01535664|B1|Baseline|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
156896|NCT01535664|P1|Participant Flow|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
156897|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
156898|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
156899|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
156900|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
156901|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
156902|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
156903|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
156904|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
156905|NCT01535664|O2|Outcome|Dalfampridine-ER 10 mg|
156906|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
156907|NCT01535664|E2|Reported Event|Dalfampridine-ER Withdrawn|
156908|NCT01535664|E1|Reported Event|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg
Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
156909|NCT01535638|B1|Baseline|All Subjects|This study was conducted in healthy male subjects as open-label, single-dose, randomised three-way crossover trial to investigate relative bioavailability. Each subject was planned to receive all 3 treatments in a randomly assigned order. The treatments were 3 single doses of 600 mg (3 film-coated tablets à 200 mg each) of Deleobuvir, either as TF II (trial formulation 2) formulation, FF (final formulation) formulation or as FF modified formulation.
156910|NCT01535638|P6|Participant Flow|Final Formulation (FF) Modified / FF / Trial Formulation II|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation modified, Final Formulation and Trial Formulation II. There was a wash out period of at least 6 days between each drug administration.
156911|NCT01535638|P5|Participant Flow|Final Formulation (FF) Modified / Trial Formulation II / FF|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation modified, Trial Formulation II and Final Formulation. There was a wash out period of at least 6 days between each drug administration.
156912|NCT01535638|P4|Participant Flow|Final Formulation (FF) / FF Modified / Trial Formulation II|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation, Final Formulation modified and Trial Formulation II. There was a wash out period of at least 6 days between each drug administration.
156913|NCT01535638|P3|Participant Flow|Final Formulation (FF) / Trial Formulation II / FF Modified|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation, Trial Formulation II and Final Formulation modified. There was a wash out period of at least 6 days between each drug administration.
156914|NCT01535638|P2|Participant Flow|Trial Formulation II / Final Formulation (FF) Modified / FF|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Trial Formulation II, Final Formulation modified and Final Formulation. There was a wash out period of at least 6 days between each drug administration.
156915|NCT01535638|P1|Participant Flow|Trial Formulation II / Final Formulation (FF) / FF Modified|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Trial Formulation (TF) II, Final Formulation (FF) and FF modified. There was a wash out period of at least 6 days between each drug administration.
156916|NCT01535638|O3|Outcome|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.
600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
156917|NCT01535638|O2|Outcome|Deleobuvir Final Formulation|"Final formulation film-coated tablets.
600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
156918|NCT01535638|O1|Outcome|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.
600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
156919|NCT01535638|O3|Outcome|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.
600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
156920|NCT01535638|O2|Outcome|Deleobuvir Final Formulation|"Final formulation film-coated tablets.
600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
156921|NCT01535638|O1|Outcome|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.
600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
156922|NCT01535638|E4|Reported Event|Deleobuvir (Total)|All subjects while on treatment with Deleobuvir, i.e. there is no distinction between the 3 formulations.
156923|NCT01535638|E3|Reported Event|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.
600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
156924|NCT01535638|E2|Reported Event|Deleobuvir Final Formulation|"Final formulation film-coated tablets.
600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
156925|NCT01535638|E1|Reported Event|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.
600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
156926|NCT01535599|B3|Baseline|Total|Total of all reporting groups
156927|NCT01535599|B2|Baseline|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
156928|NCT01535599|B1|Baseline|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
156929|NCT01535599|P2|Participant Flow|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
156930|NCT01535599|P1|Participant Flow|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
156931|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
156932|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
156933|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
156934|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
156935|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
156936|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
156937|NCT01535599|E2|Reported Event|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
156938|NCT01535599|E1|Reported Event|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
156939|NCT01535560|B3|Baseline|Total|Total of all reporting groups
156940|NCT01535560|B2|Baseline|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
156941|NCT01535560|B1|Baseline|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
156942|NCT01535560|P2|Participant Flow|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
156943|NCT01535560|P1|Participant Flow|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
156944|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
156945|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
156946|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
156947|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
156948|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
156949|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
156950|NCT01535560|E2|Reported Event|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
156951|NCT01535560|E1|Reported Event|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
156952|NCT01535365|B3|Baseline|Total|Total of all reporting groups
156964|NCT01535326|B3|Baseline|Water Exchange|"infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy"
156965|NCT01535326|B2|Baseline|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal"
156966|NCT01535326|B1|Baseline|Air Insufflation|"Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy"
156967|NCT01535326|P3|Participant Flow|Water Exchange|"infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy"
156968|NCT01535326|P2|Participant Flow|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal"
156969|NCT01535326|P1|Participant Flow|Air Insufflation|"Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy"
156970|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy"
156971|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal"
156972|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy"
156973|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy"
156974|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal"
156975|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy"
156976|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy"
156977|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal"
156978|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy"
156979|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy
Proportion of no pain: 61.1%"
156980|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal
Proportion of no pain: 43.3%"
156981|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy
Proportion of no pain: 30%"
156982|NCT01535326|E3|Reported Event|Water Exchange|"infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy"
156983|NCT01535326|E2|Reported Event|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal"
156984|NCT01535326|E1|Reported Event|Air Insufflation|"Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy"
156985|NCT01535261|B1|Baseline|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
156986|NCT01535261|P1|Participant Flow|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
156987|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
156988|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
156989|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
156990|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
156991|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
156992|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
156993|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
156994|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
156995|NCT01535261|E1|Reported Event|Ranibizumab 0.5mg|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
156996|NCT01535235|B3|Baseline|Total|Total of all reporting groups
156997|NCT01535235|B2|Baseline|Placebo|"Placebo group
Placebo: Placebo Daily x24wks"
156998|NCT01535235|B1|Baseline|ACE Inhibitor|"Active group
Lisinopril: Lisinopril 20mg Daily x 24 weeks"
156999|NCT01535235|P2|Participant Flow|Placebo|"Placebo group
Placebo: Placebo QD x24wks"
157000|NCT01535235|P1|Participant Flow|ACE Inhibitor|"Active group
Lisinopril: Lisinopril 20mg QD x 24 weeks"
157001|NCT01535235|O2|Outcome|Placebo|"Placebo group
Placebo: Placebo QD x24wks"
157002|NCT01535235|O1|Outcome|ACE Inhibitor|"Active group
Lisinopril: Lisinopril 20mg QD x 24 weeks"
157003|NCT01535235|O2|Outcome|Placebo|"Placebo group
Placebo: Placebo QD x24wks"
157004|NCT01535235|O1|Outcome|ACE Inhibitor|"Active group
Lisinopril: Lisinopril 20mg QD x 24 weeks"
157005|NCT01535235|E2|Reported Event|Placebo|"Placebo group
Placebo: Placebo QD x24wks"
157006|NCT01535235|E1|Reported Event|ACE Inhibitor|"Active group
Lisinopril: Lisinopril 20mg QD x 24 weeks"
157007|NCT01535222|B7|Baseline|Total|Total of all reporting groups
157008|NCT01535222|B6|Baseline|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
157009|NCT01535222|B5|Baseline|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
157010|NCT01535222|B4|Baseline|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
157011|NCT01535222|B3|Baseline|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
157017|NCT01535222|P3|Participant Flow|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
157018|NCT01535222|P2|Participant Flow|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
157019|NCT01535222|P1|Participant Flow|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
157020|NCT01535222|O6|Outcome|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
157021|NCT01535222|O5|Outcome|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
157022|NCT01535222|O4|Outcome|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
157023|NCT01535222|O3|Outcome|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
157024|NCT01535222|O2|Outcome|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
157025|NCT01535222|O1|Outcome|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
157026|NCT01535222|O6|Outcome|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
157027|NCT01535222|O5|Outcome|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
157028|NCT01535222|O4|Outcome|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
157029|NCT01535222|O3|Outcome|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
157030|NCT01535222|O2|Outcome|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
157031|NCT01535222|O1|Outcome|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
157035|NCT01535222|E3|Reported Event|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
157036|NCT01535222|E2|Reported Event|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
157037|NCT01535222|E1|Reported Event|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
157038|NCT01535118|B1|Baseline|Adults and Children With ARC|Adults and children with ARC who complete the survey
157039|NCT01535118|P1|Participant Flow|Adults and Children With Allergic Rhinoconjunctivitis (ARC)|Adults and children with ARC who complete the survey
157040|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
157041|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
157042|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
157043|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
157044|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
157045|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
157046|NCT01535118|E1|Reported Event|Adults and Children With ARC|Adults and children with ARC who complete the survey
157047|NCT01535040|B3|Baseline|Total|Total of all reporting groups
157048|NCT01535040|B2|Baseline|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks."
157049|NCT01535040|B1|Baseline|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
157050|NCT01535040|P2|Participant Flow|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks."
157051|NCT01535040|P1|Participant Flow|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
157052|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks."
157053|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
157054|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks."
157055|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
157056|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks."
157057|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
157058|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks."
157131|NCT01534910|O2|Outcome|Aged Garlic Extract|"2400 mg of aged garlic extract
aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events"
157633|NCT01532973|O1|Outcome|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
157059|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
157060|NCT01535040|E2|Reported Event|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks."
157061|NCT01535040|E1|Reported Event|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
157062|NCT01535001|B3|Baseline|Total|Total of all reporting groups
157063|NCT01535001|B2|Baseline|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157064|NCT01535001|B1|Baseline|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157096|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.
Placebo: Oral administration, BID; for a maximum of 112 days."
157065|NCT01535001|P2|Participant Flow|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157066|NCT01535001|P1|Participant Flow|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157067|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157068|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157069|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157070|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157071|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157072|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157073|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157074|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157075|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157076|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157097|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157077|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157078|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157079|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157080|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157081|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157082|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157083|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157084|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157085|NCT01535001|E2|Reported Event|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet."
157132|NCT01534910|O1|Outcome|Sugar Pill|"placebo
placebo: placebo patients were randomized to placebo No adverse events"
157086|NCT01535001|E1|Reported Event|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazole: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes."
157087|NCT01534962|B5|Baseline|Total|Total of all reporting groups
157088|NCT01534962|B4|Baseline|Placebo|Placebo, oral, BID.
157089|NCT01534962|B3|Baseline|Ranolazin High Dose|Ranolazine, high dose, oral, BID
157090|NCT01534962|B2|Baseline|Ranolazine Intermediate Dose|Ranolazine, intermediate dose, oral, BID
157091|NCT01534962|B1|Baseline|Ranolazine Low Dose|Ranolazine, low dose, oral, BID
157092|NCT01534962|P4|Participant Flow|Placebo|"Placebo (sugar pill), oral, BID.
Placebo: Oral administration, BID; for a maximum of 112 days."
157093|NCT01534962|P3|Participant Flow|Ranolazin High Dose|"Ranolazine, high dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157094|NCT01534962|P2|Participant Flow|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157095|NCT01534962|P1|Participant Flow|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157098|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157099|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157100|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.
Placebo: Oral administration, BID; for a maximum of 112 days."
157101|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157102|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157103|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157104|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.
Placebo: Oral administration, BID; for a maximum of 112 days."
157105|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157106|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157107|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157108|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.
Placebo: Oral administration, BID; for a maximum of 112 days."
157109|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157110|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157111|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157112|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.
Placebo: Oral administration, BID; for a maximum of 112 days."
157113|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157114|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157115|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157116|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.
Placebo: Oral administration, BID; for a maximum of 112 days."
157117|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157118|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157119|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157120|NCT01534962|E4|Reported Event|Placebo|"Placebo (sugar pill), oral, BID.
Placebo: Oral administration, BID; for a maximum of 112 days."
157121|NCT01534962|E3|Reported Event|Ranolazin High Dose|"Ranolazine, high dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157122|NCT01534962|E2|Reported Event|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157123|NCT01534962|E1|Reported Event|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID
Ranolazine: Oral administration, BID; for a maximum of 112 days."
157124|NCT01534910|B3|Baseline|Total|Total of all reporting groups
157125|NCT01534910|B2|Baseline|Aged Garlic Extract|"2400 mg of aged garlic extract
aged garlic extract: 2400 mg a day patients randomized to aged garlic extract"
157126|NCT01534910|B1|Baseline|Sugar Pill|"placebo
placebo: placebo patients were randomized to placebo"
157127|NCT01534910|P2|Participant Flow|Aged Garlic Extract|"2400 mg of aged garlic extract
aged garlic extract: 2400 mg a day"
157128|NCT01534910|P1|Participant Flow|Sugar Pill|"placebo
placebo: placebo"
157129|NCT01534910|O2|Outcome|Aged Garlic Extract|"2400 mg of aged garlic extract
aged garlic extract: 2400 mg a day"
157130|NCT01534910|O1|Outcome|Sugar Pill|"placebo
placebo: placebo"
157133|NCT01534910|E2|Reported Event|Aged Garlic Extract|"2400 mg of aged garlic extract
aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events"
157134|NCT01534910|E1|Reported Event|Sugar Pill|"placebo
placebo: placebo patients were randomized to placebo No adverse events"
157135|NCT01534897|B1|Baseline|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
157136|NCT01534897|P1|Participant Flow|GSK2118436|"Note: This is a single arm feasibility study.
Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
157137|NCT01534897|O1|Outcome|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
157138|NCT01534897|O1|Outcome|GSK2118436|"Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
157139|NCT01534897|O1|Outcome|GSK2118436|"Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
157140|NCT01534897|O1|Outcome|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
157141|NCT01534897|O1|Outcome|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
157142|NCT01534897|E1|Reported Event|GSK2118436|"Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
157143|NCT01534689|B1|Baseline|Erchonia FX-405™ Laser|"The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW
Erchonia FX-405™ Laser: The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time."
157144|NCT01534689|P1|Participant Flow|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
157145|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
157146|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
157147|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
157148|NCT01534689|E1|Reported Event|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
157149|NCT01534676|B3|Baseline|Total|Total of all reporting groups
157150|NCT01534676|B2|Baseline|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
157151|NCT01534676|B1|Baseline|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
157152|NCT01534676|P2|Participant Flow|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
157153|NCT01534676|P1|Participant Flow|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
157154|NCT01534676|O2|Outcome|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
157155|NCT01534676|O1|Outcome|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
157156|NCT01534676|E2|Reported Event|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
157157|NCT01534676|E1|Reported Event|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
157187|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
157188|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
157189|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
157190|NCT01534533|O3|Outcome|Lutein and Lycopene Group (LL Group)|received 20mg lutein and 20mg lycopene
157158|NCT01534637|B1|Baseline|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.
PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
157159|NCT01534637|P1|Participant Flow|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.
PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
157160|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.
PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
157161|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.
PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
157162|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.
PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
157163|NCT01534637|E1|Reported Event|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.
PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
157164|NCT01534533|B5|Baseline|Total|Total of all reporting groups
157165|NCT01534533|B4|Baseline|Normal Lutein Group|subjects without early atherosclerosis
157166|NCT01534533|B3|Baseline|Lutein and Lycopene Group|lutein plus lycopene group
157167|NCT01534533|B2|Baseline|Lutein Group|20mg lutein per day
157173|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
157174|NCT01534533|O3|Outcome|Combination Group (LL Group)|early atherosclerosis cases received 20mg lutein and 20mg lycopene
157175|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
157176|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
157177|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
157178|NCT01534533|O3|Outcome|Lutein and Lycopene Group (LL Group)|received 20mg lutein and 20mg lycopene
157179|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
157180|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
157181|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
157182|NCT01534533|O3|Outcome|Combination Group (LL Group)|received 20mg lutein and 20mg lycopene
157183|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
157184|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
157185|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
157186|NCT01534533|O3|Outcome|Combination Group (LL Group)|received 20mg lutein and 20mg lycopene
157193|NCT01534533|E4|Reported Event|Normal Lutein Control Group|20mg lutein for subjects free from atherosclerosis, once a day
157194|NCT01534533|E3|Reported Event|Combination Group|early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day
157195|NCT01534533|E2|Reported Event|Lutein Group|early atherosclerosis cases, received 20mg lutein, once a day
157196|NCT01534533|E1|Reported Event|Placebo|early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day
157197|NCT01534520|B3|Baseline|Total|Total of all reporting groups
157198|NCT01534520|B2|Baseline|Group 2: Intravaginal Placebo Gel|4mL placebo gel (K-Y Jelly) for vaginal self-administration
157199|NCT01534520|B1|Baseline|Group 1: Intravaginal 2% Lidocaine Gel|"4mL of 2% lidocaine gel for vaginal self-administration
)"
157200|NCT01534520|P2|Participant Flow|Group 2: Intravaginal Placebo Gel|Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
157201|NCT01534520|P1|Participant Flow|Group 1: Intravaginal 2% Lidocaine Gel|4 ml of 2% lidocaine gel for self vaginal insertion
157202|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
157203|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|4 ml of 2% lidocaine gel for self vaginal insertion
157204|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)
Placebo: KY Jelly"
157205|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel
Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel"
157206|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)
Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel"
157207|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel
Placebo: KY Jelly"
157208|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)
Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel"
157209|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel
Placebo: KY Jelly"
157210|NCT01534520|E2|Reported Event|Study Drug|"Intravaginal insertion of 4mL 2% lidocaine gel
Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel"
157211|NCT01534520|E1|Reported Event|Placebo|"Intravaginal insertion of 4mL placebo gel
Placebo: KY Jelly"
157212|NCT01534351|B4|Baseline|Total|Total of all reporting groups
157213|NCT01534351|B3|Baseline|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157214|NCT01534351|B2|Baseline|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157215|NCT01534351|B1|Baseline|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157216|NCT01534351|P3|Participant Flow|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157217|NCT01534351|P2|Participant Flow|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157218|NCT01534351|P1|Participant Flow|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157249|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157219|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157220|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157221|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157222|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157223|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157224|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157225|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157226|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157227|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157228|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157229|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157230|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157231|NCT01534351|E3|Reported Event|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157232|NCT01534351|E2|Reported Event|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157233|NCT01534351|E1|Reported Event|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
157234|NCT01534208|B3|Baseline|Total|Total of all reporting groups
157235|NCT01534208|B2|Baseline|Androxal 25 mg|"Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157236|NCT01534208|B1|Baseline|Androxal 12.5 mg|"Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157237|NCT01534208|P2|Participant Flow|Androxal 25 mg|"Androxal 25 mg daily
Androxal, oral, 25 mg capsule, taken once daily"
157238|NCT01534208|P1|Participant Flow|Androxal 12.5 mg|"Androxal 12.5 mg daily
Androxal, oral, 12.5 mg capsule, taken once daily"
157239|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157240|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157241|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157242|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157243|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157244|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157245|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157246|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157247|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157248|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157250|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157251|NCT01534208|E2|Reported Event|Androxal 25 mg|"Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157252|NCT01534208|E1|Reported Event|Androxal 12.5 mg|"Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
157253|NCT01534182|B3|Baseline|Total|Total of all reporting groups
157254|NCT01534182|B2|Baseline|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
157255|NCT01534182|B1|Baseline|Fingolimod|Participants received 0.5 mg orally once a day.
157256|NCT01534182|P2|Participant Flow|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
157257|NCT01534182|P1|Participant Flow|Fingolimod|Participants received 0.5 mg orally once a day.
157258|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
157259|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
157260|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
157261|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
157262|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
157263|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
157264|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
157265|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
157266|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
157267|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
157268|NCT01534182|E3|Reported Event|Standard Disease Modifying Therapy: Glatiramer Acetate|Patients who received glatiramer acetate (GA), 20 mg subcutaneously once a day.
157269|NCT01534182|E2|Reported Event|Standard Disease Modifying Therapy (DMT): Interferon Beta-1a|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week
157270|NCT01534182|E1|Reported Event|Fingolimod|Participants received 0.5 mg orally once a day.
157271|NCT01534143|B1|Baseline|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157272|NCT01534143|P1|Participant Flow|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157273|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157274|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157275|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157287|NCT01534078|B1|Baseline|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
191317|NCT01405794|O2|Outcome|32ppm Oral Silver|
157276|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157277|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157278|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157315|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157279|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157280|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157281|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157282|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157283|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157284|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157285|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157286|NCT01534143|E1|Reported Event|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.
GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.
anti-thymocyte globulin : Given IV
pharmacological study : Correlative studies
fludarabine phosphate : Given IV
busulfan : Given IV
bortezomib : Given IV
allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT
tacrolimus : Given IV
laboratory biomarker analysis : Correlative studies
sirolimus : Given PO"
157288|NCT01534078|P1|Participant Flow|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine (AVD)
Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
157289|NCT01534078|O1|Outcome|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
157290|NCT01534078|O1|Outcome|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
157291|NCT01534078|O1|Outcome|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
157292|NCT01534078|O1|Outcome|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
157293|NCT01534078|E1|Reported Event|Treatment Arm|"Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine"
157294|NCT01533974|B3|Baseline|Total|Total of all reporting groups
157295|NCT01533974|B2|Baseline|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
157296|NCT01533974|B1|Baseline|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.
Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
157297|NCT01533974|P2|Participant Flow|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
157298|NCT01533974|P1|Participant Flow|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.
Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
157299|NCT01533974|O2|Outcome|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
157300|NCT01533974|O1|Outcome|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.
Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
157301|NCT01533974|E2|Reported Event|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
157302|NCT01533974|E1|Reported Event|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.
Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
157303|NCT01533935|B1|Baseline|Overall Study|"A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were:
Oral inhalation of placebo
Tiotropium fixed dose 5 µg
Olodaterol fixed dose 5 µg
Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence"
157304|NCT01533935|P5|Participant Flow|Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
Oral inhalation of placebo
Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
Tiotropium fixed dose 5 µg"
157305|NCT01533935|P4|Participant Flow|Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
Olodaterol fixed dose 5 µg
Oral inhalation of placebo
Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
157306|NCT01533935|P3|Participant Flow|Tio / Olo / Placebo / Tio+Olo 2.5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
Tiotropium fixed dose 5 µg
Olodaterol fixed dose 5 µg
Oral inhalation of placebo
Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg"
157307|NCT01533935|P2|Participant Flow|Tio+Olo 5/5 / Tio / Olo / Placebo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
Tiotropium fixed dose 5 µg
Olodaterol fixed dose 5 µg
Oral inhalation of placebo"
157308|NCT01533935|P1|Participant Flow|Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg.
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
Tiotropium fixed dose 5 µg
Olodaterol fixed dose 5 µg"
157309|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157310|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157311|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157312|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157313|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
157314|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
158092|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
157316|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157317|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157318|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
157319|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157320|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157321|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157322|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157323|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
157324|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157325|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157326|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157327|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157328|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
157329|NCT01533935|E5|Reported Event|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157330|NCT01533935|E4|Reported Event|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157331|NCT01533935|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157332|NCT01533935|E2|Reported Event|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157333|NCT01533935|E1|Reported Event|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
157334|NCT01533922|B1|Baseline|Overall Study|"A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The 5 treatments, administered orally via the respimat inhaler, once daily, in the morning were:
Oral inhalation of placebo
Olodaterol fixed dose 5 µg
Tiotropium fixed dose 5 µg
Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence"
157335|NCT01533922|P5|Participant Flow|Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:
Oral inhalation of placebo
Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
Tiotropium fixed dose 5 µg"
157365|NCT01533753|B3|Baseline|Total|Total of all reporting groups
157336|NCT01533922|P4|Participant Flow|Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:
Olodaterol fixed dose 5 µg
Oral inhalation of placebo
Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
157337|NCT01533922|P3|Participant Flow|Tio / Olo / Placebo / Tio+Olo 2.5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:
Tiotropium fixed dose 5 µg
Olodaterol fixed dose 5 µg
Oral inhalation of placebo
Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg"
157338|NCT01533922|P2|Participant Flow|Tio+Olo 5/5 / Tio / Olo / Placebo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
Tiotropium fixed dose 5 µg
Olodaterol fixed dose 5 µg
Oral inhalation of placebo"
157339|NCT01533922|P1|Participant Flow|Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:
Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
Tiotropium fixed dose 5 µg
Olodaterol fixed dose 5 µg"
157340|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
158720|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
157341|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157342|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157343|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157344|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
157345|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157346|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157347|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157348|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157349|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
157350|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157351|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157352|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157353|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157354|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
157355|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157356|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157357|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157358|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157359|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
157360|NCT01533922|E5|Reported Event|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157361|NCT01533922|E4|Reported Event|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157362|NCT01533922|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157363|NCT01533922|E2|Reported Event|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
157364|NCT01533922|E1|Reported Event|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
157366|NCT01533753|B2|Baseline|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.
Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
157367|NCT01533753|B1|Baseline|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.
Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
157368|NCT01533753|P2|Participant Flow|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.
Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
157387|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
157388|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
157389|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
157390|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
157369|NCT01533753|P1|Participant Flow|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.
Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
157370|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.
Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
157371|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.
Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
157372|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.
Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
157373|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.
Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
157374|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.
Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
157375|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.
Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
157376|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.
Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
157377|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.
Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
157378|NCT01533753|E2|Reported Event|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.
Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
157447|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157448|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157449|NCT01533428|E2|Reported Event|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
191318|NCT01405794|O1|Outcome|Placebo|
157379|NCT01533753|E1|Reported Event|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.
Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
157380|NCT01533597|B3|Baseline|Total|Total of all reporting groups
157381|NCT01533597|B2|Baseline|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
157382|NCT01533597|B1|Baseline|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
157383|NCT01533597|P2|Participant Flow|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
157384|NCT01533597|P1|Participant Flow|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
157385|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
157386|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
158093|NCT01530243|E4|Reported Event|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
157391|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
157392|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
157393|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
157394|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
157395|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
157396|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
157397|NCT01533597|E2|Reported Event|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
157398|NCT01533597|E1|Reported Event|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
157399|NCT01533493|B3|Baseline|Total|Total of all reporting groups
157400|NCT01533493|B2|Baseline|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate
Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.
OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
157401|NCT01533493|B1|Baseline|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate
Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.
OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
157402|NCT01533493|P2|Participant Flow|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate
Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.
OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
157403|NCT01533493|P1|Participant Flow|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate
Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.
OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
157404|NCT01533493|O2|Outcome|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate
Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.
OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
157450|NCT01533428|E1|Reported Event|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157451|NCT01533259|B1|Baseline|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
157634|NCT01532973|O5|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during.
157405|NCT01533493|O1|Outcome|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate
Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.
OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
157406|NCT01533493|E2|Reported Event|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate
Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.
OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
157458|NCT01533246|P1|Participant Flow|Treatment (Linsitinib)|"Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies"
157407|NCT01533493|E1|Reported Event|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate
Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.
OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
157408|NCT01533428|B3|Baseline|Total|Total of all reporting groups
157409|NCT01533428|B2|Baseline|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157410|NCT01533428|B1|Baseline|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157411|NCT01533428|P2|Participant Flow|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157412|NCT01533428|P1|Participant Flow|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157413|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157414|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157415|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157416|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157417|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157418|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157419|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157420|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157421|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157422|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157423|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157424|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157425|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157426|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157427|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157428|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157429|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157430|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157431|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157432|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157433|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157434|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157435|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157436|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157437|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157438|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157439|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157440|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157441|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157442|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157443|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157444|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157445|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
157446|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
157452|NCT01533259|P1|Participant Flow|Stribild|Switch from existing treatment regimen to Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regiment (STR) once daily for 48 weeks
157453|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
157454|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
157455|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
157456|NCT01533259|E1|Reported Event|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
157457|NCT01533246|B1|Baseline|Treatment (Linsitinib)|"Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies"
158094|NCT01530243|E3|Reported Event|Tolterodine|Tolterodine: 2 mg daily
157459|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies"
157460|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies"
157461|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies"
157462|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies"
157463|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies"
157464|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies"
157465|NCT01533246|E1|Reported Event|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
linsitinib: Given PO
laboratory biomarker analysis: Correlative studies"
157466|NCT01533181|B3|Baseline|Total|Total of all reporting groups
157467|NCT01533181|B2|Baseline|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
157468|NCT01533181|B1|Baseline|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
157469|NCT01533181|P2|Participant Flow|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
157470|NCT01533181|P1|Participant Flow|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
157471|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
157472|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
157473|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
157474|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
157475|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
157476|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
157477|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
157478|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
157479|NCT01533181|E2|Reported Event|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
157480|NCT01533181|E1|Reported Event|Arm A: Topotocan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
157482|NCT01533116|B4|Baseline|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157483|NCT01533116|B3|Baseline|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157484|NCT01533116|B2|Baseline|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157485|NCT01533116|B1|Baseline|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide"
157486|NCT01533116|P4|Participant Flow|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157487|NCT01533116|P3|Participant Flow|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157488|NCT01533116|P2|Participant Flow|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
158095|NCT01530243|E2|Reported Event|Terazosin|Terazosin: 2 mg BID
157489|NCT01533116|P1|Participant Flow|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide"
157490|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157491|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157492|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157493|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide"
157494|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157495|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157496|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157497|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide"
157498|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157499|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157500|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157501|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide"
157502|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157503|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157504|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157505|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide"
157506|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157507|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157508|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157509|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide"
157510|NCT01533116|E4|Reported Event|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157635|NCT01532973|O4|Outcome|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
157511|NCT01533116|E3|Reported Event|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157512|NCT01533116|E2|Reported Event|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide"
157513|NCT01533116|E1|Reported Event|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide"
157514|NCT01533077|B5|Baseline|Total|Total of all reporting groups
157515|NCT01533077|B4|Baseline|Group 4|"Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg
BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)
Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
157516|NCT01533077|B3|Baseline|Group 3|"Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg
BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)
Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
157517|NCT01533077|B2|Baseline|Group 2|"Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25
BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)
Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
157518|NCT01533077|B1|Baseline|Group 1|"Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25
BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)
Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
157519|NCT01533077|P4|Participant Flow|Group 4|"Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg
BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)
Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
157520|NCT01533077|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg
BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)
Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
157521|NCT01533077|P2|Participant Flow|Group 2|"Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25
BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)
Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
157522|NCT01533077|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25
BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)
Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
157523|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157524|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157525|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
157526|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157527|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157528|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
157529|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157530|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157531|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
157532|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157533|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157534|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
157535|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157536|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157537|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157538|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157539|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157540|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157541|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157542|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157543|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157544|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157545|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157546|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157547|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157548|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157549|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157550|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157551|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157552|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157553|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157554|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157555|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157556|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157557|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157558|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157559|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157560|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157561|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157562|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157563|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157564|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157565|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157566|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157567|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157568|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157569|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
157570|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
157571|NCT01533077|E4|Reported Event|Sinemet® 100/25 mg|Sinemet® 100/25 mg.
157572|NCT01533077|E3|Reported Event|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly.
157573|NCT01533077|E2|Reported Event|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h.
157574|NCT01533077|E1|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg.
157575|NCT01533038|B3|Baseline|Total|Total of all reporting groups
157576|NCT01533038|B2|Baseline|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery
Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
157577|NCT01533038|B1|Baseline|UroLift System|"UroLift System procedure
UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
157578|NCT01533038|P2|Participant Flow|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery
Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
157579|NCT01533038|P1|Participant Flow|UroLift System|"UroLift System procedure
UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
157580|NCT01533038|O2|Outcome|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery
Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
157636|NCT01532973|O3|Outcome|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
157581|NCT01533038|O1|Outcome|UroLift System|"UroLift System procedure
UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
157582|NCT01533038|E2|Reported Event|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery
Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
157595|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157583|NCT01533038|E1|Reported Event|UroLift System|"UroLift System procedure
UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
157584|NCT01532999|B3|Baseline|Total|Total of all reporting groups
157585|NCT01532999|B2|Baseline|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157586|NCT01532999|B1|Baseline|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157587|NCT01532999|P2|Participant Flow|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157588|NCT01532999|P1|Participant Flow|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157589|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157590|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157591|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157592|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157637|NCT01532973|O2|Outcome|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
157638|NCT01532973|O1|Outcome|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
157593|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157594|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157596|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157597|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157598|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157599|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157600|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157601|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157602|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157603|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157639|NCT01532973|O3|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
157640|NCT01532973|O2|Outcome|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
191319|NCT01405794|O2|Outcome|32ppm Oral Silver|
157604|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157605|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157606|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157607|NCT01532999|E2|Reported Event|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
157608|NCT01532999|E1|Reported Event|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
157609|NCT01532973|B10|Baseline|Total|Total of all reporting groups
157610|NCT01532973|B9|Baseline|Placebo|Participants with GT1, GT3 or GT1a HCV who received placebo in Parts I, II, or II of the study.
157611|NCT01532973|B8|Baseline|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir for 5 consecutive days during Part III of the study.
157612|NCT01532973|B7|Baseline|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir for 5 consecutive days during Part III of the study.
157613|NCT01532973|B6|Baseline|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir for 5 consecutive days during Part II of the study.
157614|NCT01532973|B5|Baseline|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir for 5 consecutive days during Part II of the study.
157615|NCT01532973|B4|Baseline|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir for 5 consecutive days during Part II of the study.
157616|NCT01532973|B3|Baseline|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir for 5 consecutive days during Part I of the study.
157617|NCT01532973|B2|Baseline|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir for 5 consecutive days during Part I of the study.
157618|NCT01532973|B1|Baseline|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis who received 10 -mg elbasvir for 5 consecutive days during Part I of the study.
157619|NCT01532973|P10|Participant Flow|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
157620|NCT01532973|P9|Participant Flow|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
157621|NCT01532973|P8|Participant Flow|GT3 HCV 200-mg Elbasvir (Panel H)|Participants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
157622|NCT01532973|P7|Participant Flow|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
157623|NCT01532973|P6|Participant Flow|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
157624|NCT01532973|P5|Participant Flow|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
157625|NCT01532973|P4|Participant Flow|GT1 HCV 200-mg Elbasvir (Panel D)|Participants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
157626|NCT01532973|P3|Participant Flow|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
157627|NCT01532973|P2|Participant Flow|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
157628|NCT01532973|P1|Participant Flow|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with genotype (GT) 1 hepatitis C virus (HCV) receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
157629|NCT01532973|O5|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
157630|NCT01532973|O4|Outcome|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
157631|NCT01532973|O3|Outcome|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
157632|NCT01532973|O2|Outcome|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
157641|NCT01532973|O1|Outcome|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
157642|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
157643|NCT01532973|O3|Outcome|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
157644|NCT01532973|O2|Outcome|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
157645|NCT01532973|O1|Outcome|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
157646|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
157647|NCT01532973|O3|Outcome|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
157648|NCT01532973|O2|Outcome|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
157649|NCT01532973|O1|Outcome|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
157650|NCT01532973|O3|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
157651|NCT01532973|O2|Outcome|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
157652|NCT01532973|O1|Outcome|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
157653|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
157654|NCT01532973|O3|Outcome|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
157655|NCT01532973|O2|Outcome|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
157656|NCT01532973|O1|Outcome|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
157657|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
157658|NCT01532973|O3|Outcome|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
157659|NCT01532973|O2|Outcome|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
157660|NCT01532973|O1|Outcome|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
157661|NCT01532973|E6|Reported Event|Post-Study|All participants who received 5, 10, 50, or 100 mg of elbasvir or placebo in treatment period of study
157662|NCT01532973|E5|Reported Event|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during.
157663|NCT01532973|E4|Reported Event|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
157664|NCT01532973|E3|Reported Event|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
157665|NCT01532973|E2|Reported Event|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
157666|NCT01532973|E1|Reported Event|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
157667|NCT01532934|B3|Baseline|Total|Total of all reporting groups
157668|NCT01532934|B2|Baseline|Standard Care (SC)|Standard Care: Individuals received assessment only, plus the usual range of services provided by Monroe County Pretrial
157669|NCT01532934|B1|Baseline|Brief Motivational Intervention Plus Standard Care (BMI+SC)|Brief Motivational Intervention plus Standard Care; Individuals received up to 4 intervention sessions plus assessment and the usual range of services provided by Monroe County Pretrial
157670|NCT01532934|P2|Participant Flow|Standard Care|"standard care
standard care: standard care"
157671|NCT01532934|P1|Participant Flow|Brief Therapy|"motivational enhancement therapy for substance use
motivational enhancement therapy: Four 45-minute MET sessions"
157672|NCT01532934|O2|Outcome|Standard Care|Assessment only plus the usual range of pretrial services
157673|NCT01532934|O1|Outcome|BMI+SC|"brief MI + standard care
standard care"
157674|NCT01532934|O2|Outcome|Standard Care|"standard care
standard care: standard care"
157675|NCT01532934|O1|Outcome|Brief Therapy|"motivational enhancement therapy for substance use
motivational enhancement therapy: Four 45-minute MET sessions"
157676|NCT01532934|O2|Outcome|Standard Care|Assessment only plus the usual range of pretrial services
157677|NCT01532934|O1|Outcome|BMI+SC|"brief MI + standard care
standard care"
157678|NCT01532934|E2|Reported Event|Standard Care|There were no adverse events for members of this group.
157679|NCT01532934|E1|Reported Event|Brief Motivational Intervention Plus Standard Care|There were no adverse events for members of this group.
157680|NCT01532869|B3|Baseline|Total|Total of all reporting groups
157681|NCT01532869|B2|Baseline|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157682|NCT01532869|B1|Baseline|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157683|NCT01532869|P2|Participant Flow|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157684|NCT01532869|P1|Participant Flow|Placebo|Participants received tocilizumab (TCZ) matched placebo by subcutaneous (SC) injection every week (qw) for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 milligrams [mg]) SC injection qw in the open-label period for Week 48 to Week 96.
191320|NCT01405794|O1|Outcome|Placebo|
157685|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157686|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157687|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157688|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157689|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157690|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157691|NCT01532869|O1|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
158096|NCT01530243|E1|Reported Event|Placebo|Placebo: same as tolterodine and terazosin dose
157692|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157693|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157694|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157695|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157696|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157697|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157698|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157699|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157700|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157701|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157702|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157703|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157704|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157705|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157706|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157707|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157708|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157709|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157710|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157711|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157712|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
157713|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
157714|NCT01532869|E6|Reported Event|Tocilizumab to Tocilizumab (up to 96 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for double-blind tocilizumab to open-label tocilizumab up to Week 96 are presented in this reporting group.
157734|NCT01532570|B3|Baseline|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157715|NCT01532869|E5|Reported Event|Placebo to Tocilizumab (up to 96 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for double-blind placebo to open-label tocilizumab up to Week 96 are presented in this reporting group.
157716|NCT01532869|E4|Reported Event|Tocilizumab (up to 48 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 48 are presented in this reporting group.
157717|NCT01532869|E3|Reported Event|Placebo (up to 48 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 48 are presented in this reporting group.
157718|NCT01532869|E2|Reported Event|Tocilizumab (up to 24 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 24 was presented in this reporting group.
157740|NCT01532570|P1|Participant Flow|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157719|NCT01532869|E1|Reported Event|Placebo (up to 24 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 24 are presented in this reporting group.
157720|NCT01532635|B1|Baseline|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157721|NCT01532635|P1|Participant Flow|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157722|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157723|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157724|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157725|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157726|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157727|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157728|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157729|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157730|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157731|NCT01532635|E1|Reported Event|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
157732|NCT01532570|B5|Baseline|Total|Total of all reporting groups
157733|NCT01532570|B4|Baseline|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157735|NCT01532570|B2|Baseline|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157736|NCT01532570|B1|Baseline|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157737|NCT01532570|P4|Participant Flow|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157738|NCT01532570|P3|Participant Flow|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157739|NCT01532570|P2|Participant Flow|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157741|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157742|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|
157743|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient No.2)|
157744|NCT01532570|O1|Outcome|Acute Neuro BD (Patient No.1)|
157745|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157746|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|
157747|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient No.2)|
157748|NCT01532570|O1|Outcome|Acute Neuro BD (Patient No.1)|
157749|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient 2)|
157750|NCT01532570|O1|Outcome|Acute Neuro BD (Patient 1)|
157751|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157752|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157753|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157754|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157755|NCT01532570|O1|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157756|NCT01532570|O1|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157757|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157758|NCT01532570|O3|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157759|NCT01532570|O2|Outcome|Neuro-BD (Acute+Chronic Progressive)|"Acute; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
Chronic Progressive; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30."
157760|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157761|NCT01532570|O4|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157762|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157763|NCT01532570|O2|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157764|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157765|NCT01532570|O4|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157766|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157821|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
157767|NCT01532570|O2|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157768|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157769|NCT01532570|E1|Reported Event|TA-650|TA-650: TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
157770|NCT01532453|B3|Baseline|Total|Total of all reporting groups
157771|NCT01532453|B2|Baseline|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
157772|NCT01532453|B1|Baseline|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
157773|NCT01532453|P2|Participant Flow|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
157774|NCT01532453|P1|Participant Flow|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
157775|NCT01532453|O2|Outcome|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
157776|NCT01532453|O1|Outcome|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
157777|NCT01532453|O2|Outcome|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
157778|NCT01532453|O1|Outcome|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
157779|NCT01532453|E2|Reported Event|MD-3511356|"Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g).
MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun."
157780|NCT01532453|E1|Reported Event|Standard Sun Protection Measures|"Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget).
Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product."
157781|NCT01532414|B4|Baseline|Total|Total of all reporting groups
157782|NCT01532414|B3|Baseline|Placebo|"Placebo oral capsules taken one time daily
Placebo: Oral capsule taken one time daily for 3 months"
157783|NCT01532414|B2|Baseline|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
157784|NCT01532414|B1|Baseline|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day"
157785|NCT01532414|P3|Participant Flow|Placebo|"Placebo oral capsules taken one time daily
Placebo: Oral capsule taken one time daily for 3 months"
157786|NCT01532414|P2|Participant Flow|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
157787|NCT01532414|P1|Participant Flow|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day"
157788|NCT01532414|O2|Outcome|Placebo|"Placebo oral capsules taken one time daily
Placebo: Oral capsule taken one time daily for 3 months"
157789|NCT01532414|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
157790|NCT01532414|O1|Outcome|Androxal Treated Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
157791|NCT01532414|E3|Reported Event|Placebo|"Placebo oral capsules taken one time daily
Placebo: Oral capsule taken one time daily for 3 months"
157792|NCT01532414|E2|Reported Event|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
157793|NCT01532414|E1|Reported Event|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily
enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
157794|NCT01532362|B3|Baseline|Total|Total of all reporting groups
157795|NCT01532362|B2|Baseline|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
157796|NCT01532362|B1|Baseline|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
157797|NCT01532362|P2|Participant Flow|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
157822|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
157823|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
157798|NCT01532362|P1|Participant Flow|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
157799|NCT01532362|O2|Outcome|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
157800|NCT01532362|O1|Outcome|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
157801|NCT01532362|E2|Reported Event|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
157802|NCT01532362|E1|Reported Event|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
157803|NCT01532349|B3|Baseline|Total|Total of all reporting groups
157835|NCT01532128|B1|Baseline|Group 1|"Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
157804|NCT01532349|B2|Baseline|4000 IU Vitamin D|Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
157805|NCT01532349|B1|Baseline|400 IU Vitamin D|Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
157806|NCT01532349|P2|Participant Flow|4000 IU Vitamin D|Children will be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
157807|NCT01532349|P1|Participant Flow|400 IU Vitamin D|Children will be randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
157808|NCT01532349|O2|Outcome|4000 IU Vitamin D|"Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
Serum hepcidin was the primary outcome variable and was quantified at all visits."
157809|NCT01532349|O1|Outcome|400 IU Vitamin D|"Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
Serum hepcidin was the primary outcome variable and was quantified at all visits."
157810|NCT01532349|E2|Reported Event|4000 IU Vitamin D|"Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
Serum hepcidin was the primary outcome variable and was quantified at all visits."
157811|NCT01532349|E1|Reported Event|400 IU Vitamin D|"Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
Serum hepcidin was the primary outcome variable and was quantified at all visits."
157812|NCT01532141|B4|Baseline|Total|Total of all reporting groups
157813|NCT01532141|B3|Baseline|Group 3|"Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)"
157814|NCT01532141|B2|Baseline|Group 2|"Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)"
157815|NCT01532141|B1|Baseline|Group 1|"Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)"
157816|NCT01532141|P3|Participant Flow|Group 3|"Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)"
157817|NCT01532141|P2|Participant Flow|Group 2|"Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)"
157818|NCT01532141|P1|Participant Flow|Group 1|"Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)"
157819|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
157820|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
157825|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
157826|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
157827|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
157828|NCT01532141|E4|Reported Event|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
157829|NCT01532141|E3|Reported Event|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
157830|NCT01532141|E2|Reported Event|BIA 9-1067 Alone|BIA 9-1067 alone.
157831|NCT01532141|E1|Reported Event|Before Treatment|Before treatment.
157832|NCT01532128|B4|Baseline|Total|Total of all reporting groups
157833|NCT01532128|B3|Baseline|Group 3|"Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
157834|NCT01532128|B2|Baseline|Group 2|"Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
157836|NCT01532128|P3|Participant Flow|Group 3|"Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
157837|NCT01532128|P2|Participant Flow|Group 2|"Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
157838|NCT01532128|P1|Participant Flow|Group 1|"Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
157839|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
157840|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
157841|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
157842|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
157843|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
157844|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
157845|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
157846|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
157847|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
157848|NCT01532128|E4|Reported Event|Rasagiline Concomitant BIA 9-1067|
157849|NCT01532128|E3|Reported Event|Rasagiline 1 h After BIA 9-1067|
157850|NCT01532128|E2|Reported Event|Rasagiline Alone|
157851|NCT01532128|E1|Reported Event|Before Treatment|
157852|NCT01531998|B1|Baseline|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
157853|NCT01531998|P1|Participant Flow|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
157854|NCT01531998|O1|Outcome|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
157855|NCT01531998|O1|Outcome|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
157856|NCT01531998|E1|Reported Event|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
157857|NCT01531725|B1|Baseline|BMS Implantation|Patients with a BMS implanted.
157858|NCT01531725|P1|Participant Flow|BMS Implantation|BMS implantation
157859|NCT01531725|O1|Outcome|BMS Implantation|BMS implantation
157863|NCT01531387|B2|Baseline|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
157864|NCT01531387|B1|Baseline|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
157865|NCT01531387|P2|Participant Flow|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
157885|NCT01531374|P1|Participant Flow|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157886|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157866|NCT01531387|P1|Participant Flow|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
157867|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
157868|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
157869|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
157870|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
157871|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
157872|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
157873|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
157874|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
157875|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
157876|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
157877|NCT01531387|E2|Reported Event|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
157878|NCT01531387|E1|Reported Event|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
157879|NCT01531374|B4|Baseline|Total|Total of all reporting groups
157880|NCT01531374|B3|Baseline|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
158073|NCT01530243|B4|Baseline|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
157881|NCT01531374|B2|Baseline|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157882|NCT01531374|B1|Baseline|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157883|NCT01531374|P3|Participant Flow|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157884|NCT01531374|P2|Participant Flow|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
158721|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
157887|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157888|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157889|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157890|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157891|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157892|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157893|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157894|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157895|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157896|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157897|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157898|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157899|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157900|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157901|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157902|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157903|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157904|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157905|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157906|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157907|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157908|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157909|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
158074|NCT01530243|B3|Baseline|Tolterodine|Tolterodine: 2 mg daily
157910|NCT01531374|O2|Outcome|High Risk: Implanted Cohort|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157911|NCT01531374|O1|Outcome|Extreme Risk: Implanted Cohort|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157912|NCT01531374|O2|Outcome|High Risk: Implanted Cohort|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157913|NCT01531374|O1|Outcome|Extreme Risk: Implanted Cohort|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157914|NCT01531374|O2|Outcome|High Risk: Implanted Cohort|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157915|NCT01531374|O1|Outcome|Extreme Risk: Implanted Cohort|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157916|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157917|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157918|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157919|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157920|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157921|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157922|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157923|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157924|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157925|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157926|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157927|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157928|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157929|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157930|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157931|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157932|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157933|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157934|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157935|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157936|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157937|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157938|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
158075|NCT01530243|B2|Baseline|Terazosin|Terazosine: 2 mg BID
158076|NCT01530243|B1|Baseline|Placebo|Placebo: same as tolterodine and terazosin dose
157939|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157940|NCT01531374|O3|Outcome|High Risk|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157941|NCT01531374|O2|Outcome|Extreme Risk: Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157942|NCT01531374|O1|Outcome|Extreme Risk: Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157943|NCT01531374|E3|Reported Event|High Risk: TAVI|"High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
158097|NCT01530087|B1|Baseline|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device
CASTLE barrier: Prototype barrier to be used in place of current two piece device"
157944|NCT01531374|E2|Reported Event|Extreme Risk: TAVI Non-Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157945|NCT01531374|E1|Reported Event|Extreme Risk: TAVI Iliofemoral|"Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)"
157946|NCT01531335|B3|Baseline|Total|Total of all reporting groups
157947|NCT01531335|B2|Baseline|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg
Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
157948|NCT01531335|B1|Baseline|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.
Standard care: 25 kcal per kg of body weight"
157949|NCT01531335|P2|Participant Flow|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg
Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
157950|NCT01531335|P1|Participant Flow|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.
Standard care: 25 kcal per kg of body weight"
157951|NCT01531335|O2|Outcome|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg
Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
157952|NCT01531335|O1|Outcome|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.
Standard care: 25 kcal per kg of body weight"
157953|NCT01531335|O2|Outcome|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg
Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
157954|NCT01531335|O1|Outcome|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.
Standard care: 25 kcal per kg of body weight"
157955|NCT01531335|E2|Reported Event|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg
Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
157956|NCT01531335|E1|Reported Event|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.
Standard care: 25 kcal per kg of body weight"
157957|NCT01531205|B1|Baseline|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
157958|NCT01531205|P1|Participant Flow|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
157959|NCT01531205|O2|Outcome|Participant Two|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
157960|NCT01531205|O1|Outcome|Participant One|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
157961|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
157962|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
157963|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
157964|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
157965|NCT01531205|E1|Reported Event|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
157999|NCT01530477|B2|Baseline|Body Composition|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
158039|NCT01530399|B6|Baseline|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
158232|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
157966|NCT01530997|B1|Baseline|De-escalated Radiation and Chemotherapy|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
158042|NCT01530399|B3|Baseline|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
157967|NCT01530997|P1|Participant Flow|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
157968|NCT01530997|O2|Outcome|Post-treatment|This data was collected 4-8 weeks after chemoradiation therapy
157969|NCT01530997|O1|Outcome|Pre-treatment|This data was collected before the treatment.
157970|NCT01530997|O3|Outcome|Post-Surgery|This data was collected at the first follow-up post surgery.
157971|NCT01530997|O2|Outcome|6-8 Weeks Post-Treatment|This data was collected 6-8 weeks post-chemoradiotherapy.
157972|NCT01530997|O1|Outcome|Baseline|This data was collected pre-chemoradiotherapy treatment.
157973|NCT01530997|O3|Outcome|Post-Surgery|This data was collected at the first follow-up post-surgery.
157974|NCT01530997|O2|Outcome|6-8 Weeks Post-Treatment|This data was collected 6-8 weeks post-chemoradiotherapy.
157975|NCT01530997|O1|Outcome|Baseline|This data was collected pre-chemoradiotherapy treatment.
157976|NCT01530997|O3|Outcome|Post-Surgery|This data was collected at the first follow-up post-surgery.
157977|NCT01530997|O2|Outcome|6-8 Weeks Post-Treatment|This data was collected 6-8 weeks post-chemoradiotherapy.
157978|NCT01530997|O1|Outcome|Baseline|This data was collected pre-chemoradiotherapy treatment.
157979|NCT01530997|O1|Outcome|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
157980|NCT01530997|O1|Outcome|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
157981|NCT01530997|O1|Outcome|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
157982|NCT01530997|O1|Outcome|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
158036|NCT01530464|E2|Reported Event|Ambrisentan Only|Ambrisentan 5 mg orally, followed by 48 h washout period. lowed by 48 h washout period.
158037|NCT01530464|E1|Reported Event|Aminophylline Only|Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.
158038|NCT01530399|B7|Baseline|Total|Total of all reporting groups
157983|NCT01530997|O1|Outcome|De-escalated Radiation and Chemotherapy|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
157984|NCT01530997|O1|Outcome|De-escalated Radiation and Chemotherapy|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively."
157985|NCT01530997|E1|Reported Event|Single Intervention|"Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively"
157986|NCT01530880|B1|Baseline|All Subjects|Includes subjects from both arms.
157987|NCT01530880|P1|Participant Flow|All Subjects|Includes subjects from both arms as this information is only available for all subjects and not per arm.
157988|NCT01530880|O2|Outcome|Standard of Care|"Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).
Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first."
157989|NCT01530880|O1|Outcome|Intravenous Ibuprofen|"Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.
Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first"
157990|NCT01530880|O2|Outcome|Standard of Care|"Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).
Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first."
157991|NCT01530880|O1|Outcome|Intravenous Ibuprofen|"Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.
Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first"
157992|NCT01530880|O2|Outcome|Standard of Care|"Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).
Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first."
157993|NCT01530880|O1|Outcome|Intravenous Ibuprofen|"Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.
Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first"
157994|NCT01530880|O2|Outcome|Standard of Care|"Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).
Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first."
157995|NCT01530880|O1|Outcome|Intravenous Ibuprofen|"Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.
Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first"
157996|NCT01530880|E1|Reported Event|All Subjects|Includes subjects from both arms as this information is only available for all subjects and not per arm.
157997|NCT01530477|B4|Baseline|Total|Total of all reporting groups
157998|NCT01530477|B3|Baseline|Skeletal and Body Composition|"Skeletal and Body Composition was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort."
158068|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
158000|NCT01530477|B1|Baseline|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
158001|NCT01530477|P3|Participant Flow|Skeletal & Body Composition|"Skeletal & Body Composition was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort."
158086|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
158087|NCT01530243|O2|Outcome|Terazosin|Terazosine: 2 mg BID
158002|NCT01530477|P2|Participant Flow|Body Composition Only|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
158003|NCT01530477|P1|Participant Flow|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
158004|NCT01530477|O2|Outcome|Body Composition Only|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
158005|NCT01530477|O1|Outcome|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
158006|NCT01530477|E2|Reported Event|Body Composition|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects).
158007|NCT01530477|E1|Reported Event|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects).
158008|NCT01530464|B3|Baseline|Total|Total of all reporting groups
158009|NCT01530464|B2|Baseline|Sequence B|"Period 1: Ambrisentan 5 mg orally, followed by 48 h washout period. Period 2: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.
Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
158010|NCT01530464|B1|Baseline|Sequence A|"Period 1: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.
Period 2: Ambrisentan 5 mg orally, followed by 48 h washout period.. Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
158011|NCT01530464|P2|Participant Flow|Sequence B|Period 1: First intervention (Ambrisentan 5mg, 24h) Period 2: Washout (24 hours) Period 3: Second intervention (Aminophylline 500mg, 24h) Period 4: Washout (24h) Period 5: Third intervention (Aminophylline 500mg plus ambrisentan 5mg, 24h) Period 6: Washout (24h)
158012|NCT01530464|P1|Participant Flow|Sequence A|Period 1: First intervention (Aminophylline 500mg, 24h) Period 2: Washout (24 hours) Period 3: Second intervention (Ambrisentan 5mg, 24h) Period 4: Washout (24h) Period 5: Third intervention (Aminophylline 500mg plus ambrisentan 5mg, 24h) Period 6: Washout (24h)
158013|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
158014|NCT01530464|O3|Outcome|Ambrisentan Alone|
158015|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
158016|NCT01530464|O1|Outcome|Aminophylline Alone|
158017|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
158018|NCT01530464|O3|Outcome|Ambrisentan Alone|
158019|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
158020|NCT01530464|O1|Outcome|Aminophylline Alone|
158021|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
158022|NCT01530464|O3|Outcome|Ambrisentan Alone|
158023|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
158024|NCT01530464|O1|Outcome|Aminophylline Alone|
158025|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
158026|NCT01530464|O3|Outcome|Ambrisentan Alone|
158027|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
158028|NCT01530464|O1|Outcome|Aminophylline Alone|
158029|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
158030|NCT01530464|O3|Outcome|Ambrisentan Alone|
158031|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
158032|NCT01530464|O1|Outcome|Aminophylline Alone|
158033|NCT01530464|O2|Outcome|Sequence B|"Period 1: Ambrisentan 5 mg orally, followed by 48 h washout period. Period 2: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.
Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
158034|NCT01530464|O1|Outcome|Sequence A|"Period 1: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.
Period 2: Ambrisentan 5 mg orally, followed by 48 h washout period.. Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
158035|NCT01530464|E3|Reported Event|Combined Aminophylline and Ambrisentan|Combined single doses of Aminophylline 400 mg and ambrisentan 5 mg, followed by a 48 h washout period
158069|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
158040|NCT01530399|B5|Baseline|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
158041|NCT01530399|B4|Baseline|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
158088|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
158089|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
158043|NCT01530399|B2|Baseline|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
158044|NCT01530399|B1|Baseline|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
158045|NCT01530399|P6|Participant Flow|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
158046|NCT01530399|P5|Participant Flow|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
158047|NCT01530399|P4|Participant Flow|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
158048|NCT01530399|P3|Participant Flow|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
158049|NCT01530399|P2|Participant Flow|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
158050|NCT01530399|P1|Participant Flow|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
158051|NCT01530399|O6|Outcome|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
158052|NCT01530399|O5|Outcome|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
158053|NCT01530399|O4|Outcome|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
158054|NCT01530399|O3|Outcome|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
158055|NCT01530399|O2|Outcome|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
158056|NCT01530399|O1|Outcome|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
158057|NCT01530399|E6|Reported Event|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
158058|NCT01530399|E5|Reported Event|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
158059|NCT01530399|E4|Reported Event|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
158060|NCT01530399|E3|Reported Event|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
158061|NCT01530399|E2|Reported Event|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
158062|NCT01530399|E1|Reported Event|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
158063|NCT01530334|B1|Baseline|Gefitinib|250 mg/die, oral
158064|NCT01530334|P1|Participant Flow|Gefitinib|250 mg/die, oral
158065|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
158066|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
158067|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
158077|NCT01530243|P4|Participant Flow|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
158078|NCT01530243|P3|Participant Flow|Tolterodine|Tolterodine: 2 mg daily
158079|NCT01530243|P2|Participant Flow|Terazosin|Terazosin: 2 mg BID
158080|NCT01530243|P1|Participant Flow|Placebo|Placebo: same as tolterodine and terazosin dose
158081|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
158082|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
158083|NCT01530243|O2|Outcome|Terazosin|Terazosin: 2 mg BID
158084|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
158085|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
158098|NCT01530087|P1|Participant Flow|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device
CASTLE barrier: Prototype barrier to be used in place of current two piece device"
158099|NCT01530087|O1|Outcome|Treatment|"CASTLE Barrier
CASTLE barrier: Prototype barrier to be used in place of current two piece device"
158100|NCT01530087|O1|Outcome|Treatment|CASTLE Barrier: Prototype barrier used in place of previous two piece device
158101|NCT01530087|E1|Reported Event|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device
CASTLE barrier: Prototype barrier to be used in place of current two piece device"
158102|NCT01529827|B1|Baseline|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.
fludarabine phosphate: Given IV
melphalan: Given IV
total-body irradiation: Undergo TBI
tacrolimus: Given IV or PO
mycophenolate mofetil: Given IV or PO
methotrexate: Given IV
laboratory biomarker analysis: Correlative studies
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
peripheral blood stem cell transplantation: Undergo PBSCT"
158103|NCT01529827|P1|Participant Flow|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.
fludarabine phosphate: Given IV
melphalan: Given IV
total-body irradiation: Undergo TBI
tacrolimus: Given IV or PO
mycophenolate mofetil: Given IV or PO
methotrexate: Given IV
laboratory biomarker analysis: Correlative studies
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
peripheral blood stem cell transplantation: Undergo PBSCT"
158104|NCT01529827|O1|Outcome|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.
fludarabine phosphate: Given IV
melphalan: Given IV
total-body irradiation: Undergo TBI
tacrolimus: Given IV or PO
mycophenolate mofetil: Given IV or PO
methotrexate: Given IV
laboratory biomarker analysis: Correlative studies
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
peripheral blood stem cell transplantation: Undergo PBSCT"
158105|NCT01529827|O1|Outcome|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.
fludarabine phosphate: Given IV
melphalan: Given IV
total-body irradiation: Undergo TBI
tacrolimus: Given IV or PO
mycophenolate mofetil: Given IV or PO
methotrexate: Given IV
laboratory biomarker analysis: Correlative studies
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
peripheral blood stem cell transplantation: Undergo PBSCT"
158106|NCT01529827|O1|Outcome|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.
fludarabine phosphate: Given IV
melphalan: Given IV
total-body irradiation: Undergo TBI
tacrolimus: Given IV or PO
mycophenolate mofetil: Given IV or PO
methotrexate: Given IV
laboratory biomarker analysis: Correlative studies
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
peripheral blood stem cell transplantation: Undergo PBSCT"
158133|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158107|NCT01529827|O1|Outcome|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.
fludarabine phosphate: Given IV
melphalan: Given IV
total-body irradiation: Undergo TBI
tacrolimus: Given IV or PO
mycophenolate mofetil: Given IV or PO
methotrexate: Given IV
laboratory biomarker analysis: Correlative studies
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
peripheral blood stem cell transplantation: Undergo PBSCT"
158108|NCT01529827|E1|Reported Event|Treatment (Reduced Intensity Allogeneic PBSCT)|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6.
fludarabine phosphate: Given IV
melphalan: Given IV
total-body irradiation: Undergo TBI
tacrolimus: Given IV or PO
mycophenolate mofetil: Given IV or PO
methotrexate: Given IV
laboratory biomarker analysis: Correlative studies
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
peripheral blood stem cell transplantation: Undergo PBSCT"
158109|NCT01529645|B11|Baseline|Total|Total of all reporting groups
158110|NCT01529645|B10|Baseline|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
158334|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158111|NCT01529645|B9|Baseline|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158112|NCT01529645|B8|Baseline|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158113|NCT01529645|B7|Baseline|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158114|NCT01529645|B6|Baseline|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158115|NCT01529645|B5|Baseline|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158116|NCT01529645|B4|Baseline|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158117|NCT01529645|B3|Baseline|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
158118|NCT01529645|B2|Baseline|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
158119|NCT01529645|B1|Baseline|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
158120|NCT01529645|P10|Participant Flow|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
158121|NCT01529645|P9|Participant Flow|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158122|NCT01529645|P8|Participant Flow|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158123|NCT01529645|P7|Participant Flow|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158124|NCT01529645|P6|Participant Flow|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158125|NCT01529645|P5|Participant Flow|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158126|NCT01529645|P4|Participant Flow|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on day 1 of this study.
158127|NCT01529645|P3|Participant Flow|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
158128|NCT01529645|P2|Participant Flow|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
158129|NCT01529645|P1|Participant Flow|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
158130|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
158131|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158132|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158263|NCT01529502|B7|Baseline|Total|Total of all reporting groups
158134|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158135|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158136|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158137|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
158138|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
158139|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
158140|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
158141|NCT01529645|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158142|NCT01529645|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158143|NCT01529645|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158144|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
158145|NCT01529645|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158146|NCT01529645|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158147|NCT01529645|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158148|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
158149|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
158150|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
158151|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
158152|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
158153|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158154|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158155|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158156|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158157|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158158|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158159|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
158160|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
158161|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
158162|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
158163|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158164|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
159162|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
158165|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158166|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158167|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158168|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158169|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
158170|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
158171|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
158172|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
158173|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158174|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158175|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158176|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158177|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158178|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158179|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
158180|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
158181|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
158182|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
158183|NCT01529645|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158184|NCT01529645|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158185|NCT01529645|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158186|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
158187|NCT01529645|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158188|NCT01529645|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158189|NCT01529645|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158190|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
158191|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
158192|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
158193|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
158194|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
158195|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158231|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
158196|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158197|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158198|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158199|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158200|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158201|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
158202|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
158203|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
158204|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
158205|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158206|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158207|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158208|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158209|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158210|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158211|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
158212|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
158213|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
158214|NCT01529645|E10|Reported Event|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
158215|NCT01529645|E9|Reported Event|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158216|NCT01529645|E8|Reported Event|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158217|NCT01529645|E7|Reported Event|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158218|NCT01529645|E6|Reported Event|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158219|NCT01529645|E5|Reported Event|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158220|NCT01529645|E4|Reported Event|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
158221|NCT01529645|E3|Reported Event|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
158222|NCT01529645|E2|Reported Event|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
158223|NCT01529645|E1|Reported Event|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
158224|NCT01529632|B3|Baseline|Total|Total of all reporting groups
158225|NCT01529632|B2|Baseline|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
158226|NCT01529632|B1|Baseline|QVA149|QVA149 plus placebo once daily for 28 days.
158227|NCT01529632|P2|Participant Flow|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
158228|NCT01529632|P1|Participant Flow|QVA149|QVA149 plus placebo once daily for 28 days.
158229|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
158230|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
158233|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
158234|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
158235|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
158236|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
158237|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
158238|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
158239|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
158240|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
158241|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
158242|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
158243|NCT01529632|E2|Reported Event|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
158244|NCT01529632|E1|Reported Event|QVA149|QVA149 plus placebo once daily for 28 days.
158245|NCT01529515|B3|Baseline|Total|Total of all reporting groups
158246|NCT01529515|B2|Baseline|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
158335|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158247|NCT01529515|B1|Baseline|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
158248|NCT01529515|P4|Participant Flow|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
158249|NCT01529515|P3|Participant Flow|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
158250|NCT01529515|P2|Participant Flow|Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month|Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
158251|NCT01529515|P1|Participant Flow|Open-Label Transition Phase: Paliperidone Palmitate 1-Month|Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64.
158252|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
158253|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
158254|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
158255|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
158256|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
158257|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
158258|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
158259|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
158260|NCT01529515|E3|Reported Event|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
158261|NCT01529515|E2|Reported Event|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
158262|NCT01529515|E1|Reported Event|Open-Label Phase: PP1M + PP3M|PP1M= Paliperidone Palmitate 1 Month and PP3M= Paliperidone Palmitate 3 Month. Open-Label Transition Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64. Open-Label Maintenance Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
158264|NCT01529502|B6|Baseline|Old Blood + Inhaled Nitric Oxide- Old Blood- Fresh Blood|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
158265|NCT01529502|B5|Baseline|Old Blood + Inhaled Nitric Oxide- Fresh Blood- Old Blood|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
158276|NCT01529502|O3|Outcome|Old Blood + Inhaled Nitric Oxide|"Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
158266|NCT01529502|B4|Baseline|Old Blood- Old Blood + Inhaled Nitric Oxide- Fresh Blood|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
158267|NCT01529502|B3|Baseline|Old Blood- Fresh Blood- Old Blood + Inhaled Nitric Oxide|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
158268|NCT01529502|B2|Baseline|Fresh Blood-Old Blood + Inhaled Nitric Oxide-Old Blood-|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
158269|NCT01529502|B1|Baseline|Fresh Blood-Old Blood-Old Blood + Inhaled Nitric Oxide|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
158270|NCT01529502|P6|Participant Flow|Old Blood+iNO - Fresh Blood - Old Blood|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
158271|NCT01529502|P5|Participant Flow|Old Blood - Old Blood+iNO - Fresh Blood|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
158272|NCT01529502|P4|Participant Flow|Fresh Blood - Old Blood+iNO - Old Blood|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
158273|NCT01529502|P3|Participant Flow|Old Blood+iNO - Old Blood - Fresh Blood|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
158301|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158530|NCT01528605|E1|Reported Event|Placebo|"starch in hard shell gelatine capsules
placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
191321|NCT01405794|O2|Outcome|32ppm Oral Silver|
158274|NCT01529502|P2|Participant Flow|Old Blood - Fresh Blood - Old Blood+iNO|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
158275|NCT01529502|P1|Participant Flow|Fresh Blood - Old Blood - Old Blood+iNO|"FRESH BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.
OLD BLOOD:
Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
158277|NCT01529502|O2|Outcome|Old Blood|Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
158722|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
158278|NCT01529502|O1|Outcome|Fresh Blood|Red blood Cells auto-transfusion: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
158279|NCT01529502|O3|Outcome|Old Blood + Inhaled Nitric Oxide|"Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
158280|NCT01529502|O2|Outcome|Old Blood|Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
158281|NCT01529502|O1|Outcome|Fresh Blood|Red blood Cells auto-transfusion: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
158282|NCT01529502|E3|Reported Event|Old Blood + Inhaled Nitric Oxide|"Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
158283|NCT01529502|E2|Reported Event|Old Blood|Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
158284|NCT01529502|E1|Reported Event|Fresh Blood|Red blood Cells auto-transfusion: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
158285|NCT01529450|B3|Baseline|Total|Total of all reporting groups
158286|NCT01529450|B2|Baseline|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.
LDE225: 800-mg (4 200-mg capsules/day) capsule"
158287|NCT01529450|B1|Baseline|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.
LDE225: 800-mg (4 200-mg capsules/day) capsule"
158288|NCT01529450|P2|Participant Flow|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.
LDE225: 800-mg (4 200-mg capsules/day) capsule"
158289|NCT01529450|P1|Participant Flow|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.
LDE225: 800-mg (4 200-mg capsules/day) capsule"
158290|NCT01529450|O1|Outcome|All Participants|Participants received LDE225: 800-mg (4 200-mg capsules/day) capsule
158291|NCT01529450|O2|Outcome|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.
LDE225: 800-mg (4 200-mg capsules/day) capsule"
158292|NCT01529450|O1|Outcome|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.
LDE225: 800-mg (4 200-mg capsules/day) capsule"
158293|NCT01529450|E2|Reported Event|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.
LDE225: 800-mg (4 200-mg capsules/day) capsule"
158294|NCT01529450|E1|Reported Event|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.
LDE225: 800-mg (4 200-mg capsules/day) capsule"
158295|NCT01529385|B3|Baseline|Total|Total of all reporting groups
158296|NCT01529385|B2|Baseline|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158297|NCT01529385|B1|Baseline|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158298|NCT01529385|P2|Participant Flow|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158299|NCT01529385|P1|Participant Flow|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158300|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
191322|NCT01405794|O1|Outcome|Placebo|
158302|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158303|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158304|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158305|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158306|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158307|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158308|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158309|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158310|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158311|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158312|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158313|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158314|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158315|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158316|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158317|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158318|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158319|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158320|NCT01529385|E2|Reported Event|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.
Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
158321|NCT01529385|E1|Reported Event|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.
mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
158322|NCT01529203|B1|Baseline|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane
Botulinum Toxin Type A (Azzalure): Powder for solution for injection
Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
158323|NCT01529203|P1|Participant Flow|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane
Botulinum Toxin Type A (Azzalure): Powder for solution for injection
Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
158324|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane
Botulinum Toxin Type A (Azzalure): Powder for solution for injection
Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
158325|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane
Botulinum Toxin Type A (Azzalure): Powder for solution for injection
Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
158516|NCT01528605|O3|Outcome|High Lutein|"high lutein group
high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
158326|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane
Botulinum Toxin Type A (Azzalure): Powder for solution for injection
Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
158327|NCT01529203|E1|Reported Event|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane
Botulinum Toxin Type A (Azzalure): Powder for solution for injection
Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
158328|NCT01529112|B3|Baseline|Total|Total of all reporting groups
158329|NCT01529112|B2|Baseline|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158330|NCT01529112|B1|Baseline|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158331|NCT01529112|P2|Participant Flow|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158332|NCT01529112|P1|Participant Flow|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158333|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158336|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158337|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158338|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158339|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158340|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158341|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158342|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158343|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158344|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158345|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158346|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158347|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158348|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158349|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158350|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158351|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158352|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158353|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158354|NCT01529112|E2|Reported Event|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
158355|NCT01529112|E1|Reported Event|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
158356|NCT01528969|B3|Baseline|Total|Total of all reporting groups
158357|NCT01528969|B2|Baseline|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.
Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%."
158358|NCT01528969|B1|Baseline|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.
Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w."
158359|NCT01528969|P2|Participant Flow|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.
Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks."
158360|NCT01528969|P1|Participant Flow|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.
Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks."
158361|NCT01528969|O2|Outcome|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.
Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%."
158362|NCT01528969|O1|Outcome|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.
Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w."
158363|NCT01528969|E2|Reported Event|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.
Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%.
None of the subjects had any adverse effects of the consumption of the chewing gum."
158364|NCT01528969|E1|Reported Event|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.
Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w.
None of the subjects had any adverse effects of the consumption of the chewing gum."
158365|NCT01528891|B3|Baseline|Total|Total of all reporting groups
158366|NCT01528891|B2|Baseline|Placebo|"Normal saline equivalent volume
Placebo
Of the 200 patients in this treatment arm, 2 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol."
158367|NCT01528891|B1|Baseline|Dexmedetomidine|"Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery
Of the 200 patients in this treatment arm, 5 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol."
158368|NCT01528891|P2|Participant Flow|Placebo|"Normal saline equivalent volume
Placebo"
158369|NCT01528891|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
158370|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume
Placebo"
158371|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
158372|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume
Placebo"
158373|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
158374|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume
Placebo"
158375|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
158376|NCT01528891|O2|Outcome|Placebo|"Normal saline
Placebo"
158377|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery"
158378|NCT01528891|E2|Reported Event|Placebo|"Normal saline equivalent volume
Placebo"
158379|NCT01528891|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
158380|NCT01528735|B3|Baseline|Total|Total of all reporting groups
158381|NCT01528735|B2|Baseline|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158382|NCT01528735|B1|Baseline|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158383|NCT01528735|P2|Participant Flow|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158384|NCT01528735|P1|Participant Flow|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158385|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158386|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158387|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158388|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158389|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158390|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158517|NCT01528605|O2|Outcome|Low Lutein|"low lutein group
low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
159163|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
158391|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158392|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158393|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158394|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158541|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
158395|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158396|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158397|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158398|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158399|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158400|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158401|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158402|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158403|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158404|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158405|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158406|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158518|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules
placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
158519|NCT01528605|O6|Outcome|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group
zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
158407|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158408|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158409|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158410|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158411|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158412|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158413|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158414|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158415|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158416|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158417|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158418|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158419|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158420|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158421|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158422|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158520|NCT01528605|O5|Outcome|High Zeaxanthin|"zeaxanthin group
high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
158521|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group
lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
158423|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158424|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158425|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158426|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158427|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158428|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158429|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158430|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158431|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158432|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158433|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158434|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158435|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158436|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158437|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158438|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158522|NCT01528605|O3|Outcome|High Lutein|"high lutein group
high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
158523|NCT01528605|O2|Outcome|Low Lutein|"low lutein group
low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
158439|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158440|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158441|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158442|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158443|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158444|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158445|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158446|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158447|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158448|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158449|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158450|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158451|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158452|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158453|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158454|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158524|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules
placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
158525|NCT01528605|E6|Reported Event|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group
zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
158455|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158456|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158457|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158458|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158459|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158460|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158461|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158462|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158463|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158464|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158465|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158466|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158467|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158468|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158469|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158470|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158526|NCT01528605|E5|Reported Event|High Zeaxanthin|"zeaxanthin group
high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
158527|NCT01528605|E4|Reported Event|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group
lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
158471|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158472|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158473|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158474|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158475|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158476|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158477|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158478|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
158479|NCT01528735|E4|Reported Event|Faldap/pegIFN/RBV:120mg Faldap and 600mg Del.|Patients received 24 weeks 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV).
158480|NCT01528735|E3|Reported Event|Faldap/pegIFN/RBV:80mg Faldap and 600mg Del.|Patients received 24 weeks 120 mg once daily (qd) faldaprevir (faldap) in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV).
158481|NCT01528735|E2|Reported Event|Faldap/Del/RBV:120mg Faldap and 600mg Del.|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV)
158482|NCT01528735|E1|Reported Event|Faldap/Del/RBV:80mg Faldap and 600mg Del.|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV)
158483|NCT01528696|B3|Baseline|Total|Total of all reporting groups
158484|NCT01528696|B2|Baseline|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
158485|NCT01528696|B1|Baseline|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
158486|NCT01528696|P2|Participant Flow|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
158487|NCT01528696|P1|Participant Flow|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
158528|NCT01528605|E3|Reported Event|High Lutein|"high lutein group
high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
158529|NCT01528605|E2|Reported Event|Low Lutein|"low lutein group
low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
191323|NCT01405794|O2|Outcome|32ppm Oral Silver|
158488|NCT01528696|O2|Outcome|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
158489|NCT01528696|O1|Outcome|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
158490|NCT01528696|O2|Outcome|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
158542|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
158491|NCT01528696|O1|Outcome|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
158492|NCT01528696|O2|Outcome|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
158493|NCT01528696|O1|Outcome|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
158494|NCT01528696|E2|Reported Event|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
158495|NCT01528696|E1|Reported Event|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
158496|NCT01528605|B7|Baseline|Total|Total of all reporting groups
158497|NCT01528605|B6|Baseline|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group
zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
158498|NCT01528605|B5|Baseline|High Zeaxanthin|"zeaxanthin group
high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
158499|NCT01528605|B4|Baseline|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group
lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
158500|NCT01528605|B3|Baseline|High Lutein|"high lutein group
high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
158501|NCT01528605|B2|Baseline|Placebo|"starch in hard shell gelatine capsules
placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
158502|NCT01528605|B1|Baseline|Low Lutein|"low lutein group
low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
158503|NCT01528605|P6|Participant Flow|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group
zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
158504|NCT01528605|P5|Participant Flow|High Zeaxanthin|"zeaxanthin group
high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
158505|NCT01528605|P4|Participant Flow|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group
lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
158506|NCT01528605|P3|Participant Flow|High Lutein|"high lutein group
high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
158507|NCT01528605|P2|Participant Flow|Placebo|"starch in hard shell gelatine capsules
placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
158508|NCT01528605|P1|Participant Flow|Low Lutein|"low lutein group
low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
158509|NCT01528605|O6|Outcome|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group
zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
158510|NCT01528605|O5|Outcome|High Zeaxanthin|"zeaxanthin group
high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
158511|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group
lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
158512|NCT01528605|O3|Outcome|High Lutein|"high lutein group
high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
158513|NCT01528605|O2|Outcome|Low Lutein|"low lutein group
low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
158514|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules
placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
158515|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group
lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
191324|NCT01405794|O1|Outcome|Placebo|
158531|NCT01528592|B1|Baseline|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
158532|NCT01528592|P1|Participant Flow|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
158533|NCT01528592|O1|Outcome|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
158534|NCT01528592|E1|Reported Event|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
158535|NCT01528345|B3|Baseline|Total|Total of all reporting groups
158536|NCT01528345|B2|Baseline|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
158537|NCT01528345|B1|Baseline|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
158538|NCT01528345|P2|Participant Flow|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
158539|NCT01528345|P1|Participant Flow|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
158540|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
158715|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
158543|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
158544|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
158545|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
158546|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
158547|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
158548|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
158549|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
158550|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
158551|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
158552|NCT01528345|E2|Reported Event|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
158553|NCT01528345|E1|Reported Event|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
158554|NCT01528332|B3|Baseline|Total|Total of all reporting groups
158555|NCT01528332|B2|Baseline|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
158556|NCT01528332|B1|Baseline|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
158557|NCT01528332|P2|Participant Flow|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
158558|NCT01528332|P1|Participant Flow|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
158559|NCT01528332|O2|Outcome|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
158560|NCT01528332|O1|Outcome|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
158561|NCT01528332|E2|Reported Event|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
158562|NCT01528332|E1|Reported Event|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
158563|NCT01528319|B1|Baseline|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
158564|NCT01528319|P1|Participant Flow|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
158565|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
158566|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
158567|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
158568|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
158569|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
158570|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
158571|NCT01528319|E1|Reported Event|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
158572|NCT01528293|B3|Baseline|Total|Total of all reporting groups
158573|NCT01528293|B2|Baseline|Compression Therapy Only|"Standard of Care compression therapy only
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158604|NCT01527942|P1|Participant Flow|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
158574|NCT01528293|B1|Baseline|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158575|NCT01528293|P2|Participant Flow|Compression Therapy Only|"Standard of Care compression therapy only
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158576|NCT01528293|P1|Participant Flow|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158577|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158578|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158579|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158580|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158581|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158813|NCT01526148|O2|Outcome|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
158582|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158583|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158584|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158585|NCT01528293|E2|Reported Event|Compression Therapy Only|"Standard of Care compression therapy only
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158586|NCT01528293|E1|Reported Event|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.
ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
158587|NCT01528215|B3|Baseline|Total|Total of all reporting groups
158588|NCT01528215|B2|Baseline|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
158589|NCT01528215|B1|Baseline|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
158590|NCT01528215|P2|Participant Flow|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
158591|NCT01528215|P1|Participant Flow|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
158592|NCT01528215|O2|Outcome|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
158593|NCT01528215|O1|Outcome|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
158594|NCT01528215|E2|Reported Event|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
158595|NCT01528215|E1|Reported Event|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
158596|NCT01528150|B1|Baseline|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
158597|NCT01528150|P1|Participant Flow|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
158598|NCT01528150|O1|Outcome|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
158599|NCT01528150|E1|Reported Event|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
158600|NCT01527942|B3|Baseline|Total|Total of all reporting groups
158601|NCT01527942|B2|Baseline|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
158602|NCT01527942|B1|Baseline|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
158603|NCT01527942|P2|Participant Flow|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
159164|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
158605|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
158606|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
158607|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
158608|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
158609|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
158610|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
158716|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
158611|NCT01527942|E2|Reported Event|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
158612|NCT01527942|E1|Reported Event|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
158613|NCT01527513|B3|Baseline|Total|Total of all reporting groups
158614|NCT01527513|B2|Baseline|Placebo|Placebo QD
158615|NCT01527513|B1|Baseline|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
158616|NCT01527513|P2|Participant Flow|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 10-30 mg/kg/day QD (maximum 1200 mg/day).
158617|NCT01527513|P1|Participant Flow|Placebo|Placebo Once-Daily (QD)
158618|NCT01527513|O1|Outcome|Esl PART II|Eslicarbazepine acetate (ESL) 10-30 mg/kg/day QD (maximum 1200 mg/day).
158619|NCT01527513|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
158620|NCT01527513|O1|Outcome|Placebo|Placebo QD
158621|NCT01527513|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
158622|NCT01527513|O1|Outcome|Placebo|Placebo QD
158623|NCT01527513|E3|Reported Event|Part II - ESL|Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
158624|NCT01527513|E2|Reported Event|Part I - ESL|Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
158625|NCT01527513|E1|Reported Event|Placebo|Placebo QD
158626|NCT01527487|B3|Baseline|Total|Total of all reporting groups
158627|NCT01527487|B2|Baseline|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion;
Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard"
158628|NCT01527487|B1|Baseline|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard;
Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard"
158629|NCT01527487|P2|Participant Flow|Docetaxel+Cyclophosphamide: TC|"Docetaxel (T): 75 mg/m^2 by IV infusion (Day 1); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)tandard.
Administered every 21 days for 6 cycles followed by surgery."
158630|NCT01527487|P1|Participant Flow|Eribulin+Cyclophosphamide: ErC|"Eribulin (Er): 1.4 mg/m^2 by IV infusion (Days 1 and 8); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)
Administered every 21 days for 6 cycles followed by surgery."
158631|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion
Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard
Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.
Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks."
158632|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 IV (Days 1 and 8 of each treatment cycle) by IV infusion.
Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle by IV infusion."
158633|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.
Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
158634|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.
Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion."
158635|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.
Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
158636|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.
Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
158637|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle), by IV infusion
Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle)"
158638|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion
Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion"
158639|NCT01527487|E2|Reported Event|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion
Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard
Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.
Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks."
158640|NCT01527487|E1|Reported Event|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard
Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard
Eribulin: 1.4 mg/m2 IV (Days 1 & 8), given short (≤15 minute) IV infusion, per institutional standard
Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard."
158641|NCT01527370|B1|Baseline|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
158642|NCT01527370|P1|Participant Flow|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
158643|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
158644|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
158645|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
158646|NCT01527370|E1|Reported Event|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
158647|NCT01527162|B1|Baseline|All Participants|We used a randomized cross-over design with eleven children with bilateral 9 CP, mean age 4.3 years. Subjects were randomized to their current SAFO worn or SAFO not worn for 2 weeks and then crossed over.
158648|NCT01527162|P2|Participant Flow|SAFO NOT Worn First, Then Worn|Child does not wear their prescirbed SAFO for 14 days by random assignment, then worn
158649|NCT01527162|P1|Participant Flow|SAFO Worn First, Then Not Worn|Child wears their prescribed SAFO for 14 days by random assignment and then not worn
158650|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wears their prescribed SAFO for 14 days
158651|NCT01527162|O1|Outcome|SAFO Worn|Child wears their prescribed SAFO for 14 days
158652|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wear the prescribed SAFO for 14 days
158653|NCT01527162|O1|Outcome|SAFO Worn|Child wears their prescribed SAFO for 14 days
158654|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wear the prescribed SAFO for 14 days
158655|NCT01527162|O1|Outcome|SAFO Worn|"Child wears their prescribed SAFO for 14 days
SAFO worn: Child wears their prescribed SAFO for 14 days by random assignment
SAFO not worn: Child does not wear their prescirbed SAFO for 14 days by random assignment"
158656|NCT01527162|E2|Reported Event|SAFO Not Worn|SAFO not worn: Child does ont wear their prescribed SAFO for 14 days by random assignment
158657|NCT01527162|E1|Reported Event|SAFO Worn|SAFO worn: Child wears their prescirbed SAFO for 14 dyas by random assignment
158658|NCT01527006|B3|Baseline|Total|Total of all reporting groups
158659|NCT01527006|B2|Baseline|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158660|NCT01527006|B1|Baseline|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158661|NCT01527006|P2|Participant Flow|Cohort ( ≥ 7 to < 12 Years of Age)|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158662|NCT01527006|P1|Participant Flow|Cohort ( ≥ 2 to < 7 Years of Age)|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158663|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158664|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158814|NCT01526148|O1|Outcome|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
191325|NCT01405794|O2|Outcome|32ppm Oral Silver|
158665|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158666|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158717|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
158718|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
158719|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
158667|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158668|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158669|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158670|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158671|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158672|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158673|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158674|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158675|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158676|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158677|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158815|NCT01526148|E2|Reported Event|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
191326|NCT01405794|O1|Outcome|Placebo|
158678|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158679|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158680|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158681|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158682|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158683|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158684|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158685|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158686|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158687|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158688|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158689|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158690|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158691|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158692|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158693|NCT01527006|O4|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158694|NCT01527006|O3|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158816|NCT01526148|E1|Reported Event|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
158695|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158696|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158697|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158698|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158699|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158700|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158701|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158702|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158703|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158704|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158705|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158706|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158707|NCT01527006|E4|Reported Event|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158708|NCT01527006|E3|Reported Event|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
158709|NCT01527006|E2|Reported Event|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158710|NCT01527006|E1|Reported Event|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
158711|NCT01526902|B1|Baseline|Overall Study Population|Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
158763|NCT01526551|O1|Outcome|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic
HPV Vaccine and Disease Education: Increased education of disease and vaccine
Reduction of barriers: eliminate barriers to being vaccinated"
158712|NCT01526902|P2|Participant Flow|Lotrafilcon B (AIR OPTIX MF) / Omafilcon A (PC 1-D MF)|Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
158713|NCT01526902|P1|Participant Flow|Omafilcon A (PC 1-D MF) / Lotrafilcon B (AIR OPTIX MF)|Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
158714|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
158723|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
158724|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
158725|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
158726|NCT01526902|E2|Reported Event|Lotrafilcon B / Air Optix MF (CONTROL)|Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.
158727|NCT01526902|E1|Reported Event|Omafilcon A / PC1DMF L2A (TEST)|Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.
158728|NCT01526785|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
158729|NCT01526785|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa (4000 litre [L] scale) intravenous (IV) infusion administered for 52 weeks as per physician's routine practice.
158730|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
158731|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
158732|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
158733|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
158734|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
158735|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
158736|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
158737|NCT01526785|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per participant's routine practice.
158738|NCT01526733|B1|Baseline|All Enrolled Participants|All participants enrolled in the study.
158739|NCT01526733|P2|Participant Flow|Insulin-sham, Then Insulin-rHuPH20|"In Phase I, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injection administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.
In Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.
Phase I and Phase II were separated by a washout period of 5 to 21 days."
158740|NCT01526733|P1|Participant Flow|Insulin-rHuPH20, Then Insulin-sham|"In Phase I, participants received 0.15 units per kilogram (U/kg) insulin (either insulin aspart or insulin lispro) as a continuous subcutaneous insulin infusion (CSII) for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 milliliter (mL) (150 U) injection of recombinant human hyaluronidase PH20 (rHuPH20).
In Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.
Phase I and II were separated by a washout period of 5 to 21 days."
158741|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.
Each Phase was separated by a washout period of 5 to 21 days."
158742|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.
Each Phase was separated by a washout period of 5 to 21 days."
158743|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.
Each Phase was separated by a washout period of 5 to 21 days."
158744|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.
Each Phase was separated by a washout period of 5 to 21 days."
158745|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.
Each Phase was separated by a washout period of 5 to 21 days."
158746|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) rHuPH20.
Each Phase was separated by a washout period of 5 to 21 days."
158747|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.
Each Phase was separated by a washout period of 5 to 21 days."
158748|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.
Each Phase was separated by a washout period of 5 to 21 days."
158749|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.
Each Phase was separated by a washout period of 5 to 21 days."
158750|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.
Each Phase was separated by a washout period of 5 to 21 days."
158751|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.
Each Phase was separated by a washout period of 5 to 21 days."
158752|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.
Each Phase was separated by a washout period of 5 to 21 days."
158753|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.
Each Phase was separated by a washout period of 5 to 21 days."
158754|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.
Each Phase was separated by a washout period of 5 to 21 days."
158755|NCT01526733|E2|Reported Event|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.
Each Phase was separated by a washout period of 5 to 21 days."
158756|NCT01526733|E1|Reported Event|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.
Each Phase was separated by a washout period of 5 to 21 days."
158757|NCT01526629|B1|Baseline|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
158758|NCT01526629|P1|Participant Flow|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
158759|NCT01526629|O1|Outcome|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
158760|NCT01526629|E1|Reported Event|ICD Patients With Remote Follow-up|Patients implanted with a fully automatic ICD and remotely followed-up.
158761|NCT01526551|B1|Baseline|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic
HPV Vaccine and Disease Education: Increased education of disease and vaccine
Reduction of barriers: eliminate barriers to being vaccinated"
158762|NCT01526551|P1|Participant Flow|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic
HPV Vaccine and Disease Education: Increased education of disease and vaccine
Reduction of barriers: eliminate barriers to being vaccinated"
158817|NCT01525927|B3|Baseline|Total|Total of all reporting groups
158764|NCT01526551|O1|Outcome|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic
HPV Vaccine and Disease Education: Increased education of disease and vaccine
Reduction of barriers: eliminate barriers to being vaccinated"
158765|NCT01526551|E1|Reported Event|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic
HPV Vaccine and Disease Education: Increased education of disease and vaccine
Reduction of barriers: eliminate barriers to being vaccinated"
158766|NCT01526538|B3|Baseline|Total|Total of all reporting groups
158767|NCT01526538|B2|Baseline|Sugar Pill|"Inactive placebo
sugar pill: placebo"
158768|NCT01526538|B1|Baseline|50 mg D-cycloserine|"active drug condition
d-cycloserine: 50 mg d-cycloserine"
158769|NCT01526538|P2|Participant Flow|Sugar Pill|"Inactive placebo
sugar pill: placebo"
158770|NCT01526538|P1|Participant Flow|50 mg D-cycloserine|"active drug condition
d-cycloserine: 50 mg d-cycloserine"
158771|NCT01526538|O2|Outcome|Sugar Pill|"Inactive placebo
sugar pill: placebo"
158772|NCT01526538|O1|Outcome|50 mg D-cycloserine|"active drug condition
d-cycloserine: 50 mg d-cycloserine"
158773|NCT01526538|O2|Outcome|Control|Placebo (sugar pill)
158774|NCT01526538|O1|Outcome|D-cycloserine|Study medication under investigation
158775|NCT01526538|O2|Outcome|Sugar Pill|"Inactive placebo
sugar pill: placebo"
158776|NCT01526538|O1|Outcome|50 mg D-cycloserine|"active drug condition
d-cycloserine: 50 mg d-cycloserine"
158777|NCT01526538|E2|Reported Event|Sugar Pill|"Inactive placebo
sugar pill: placebo"
158778|NCT01526538|E1|Reported Event|50 mg D-cycloserine|"active drug condition
d-cycloserine: 50 mg d-cycloserine"
158779|NCT01526343|B1|Baseline|Reveal XT|Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
158780|NCT01526343|P1|Participant Flow|Reveal XT|Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
158781|NCT01526343|O1|Outcome|Reveal XT|Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
158782|NCT01526343|O1|Outcome|Reveal XT|Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
158783|NCT01526343|E1|Reported Event|Reveal XT|"Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
No reportable adverse events occurred."
158784|NCT01526213|B7|Baseline|Total|Total of all reporting groups
158785|NCT01526213|B6|Baseline|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158786|NCT01526213|B5|Baseline|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158787|NCT01526213|B4|Baseline|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158788|NCT01526213|B3|Baseline|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158789|NCT01526213|B2|Baseline|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158790|NCT01526213|B1|Baseline|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158791|NCT01526213|P6|Participant Flow|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
158812|NCT01526148|O1|Outcome|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
158792|NCT01526213|P5|Participant Flow|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
158793|NCT01526213|P4|Participant Flow|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
158794|NCT01526213|P3|Participant Flow|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
158795|NCT01526213|P2|Participant Flow|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
158796|NCT01526213|P1|Participant Flow|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
158871|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
158872|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
158797|NCT01526213|O3|Outcome|Furanocoumarin-free Grapefruit Juice|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
158798|NCT01526213|O2|Outcome|Grapefruit Juice|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
158799|NCT01526213|O1|Outcome|Water|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
158800|NCT01526213|E6|Reported Event|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158801|NCT01526213|E5|Reported Event|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158802|NCT01526213|E4|Reported Event|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158803|NCT01526213|E3|Reported Event|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158804|NCT01526213|E2|Reported Event|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158805|NCT01526213|E1|Reported Event|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
158806|NCT01526148|B3|Baseline|Total|Total of all reporting groups
158807|NCT01526148|B2|Baseline|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
158808|NCT01526148|B1|Baseline|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
158809|NCT01526148|P2|Participant Flow|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
158810|NCT01526148|P1|Participant Flow|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
158811|NCT01526148|O2|Outcome|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
158855|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
158818|NCT01525927|B2|Baseline|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.
chemotherapy: Chemotherapy for three cycles prior to radiotherapy
Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
158819|NCT01525927|B1|Baseline|Chemotherapy Non-responders|"Patients treated with three cycles neoadjuvant chemotherapy who do not exhibit response to chemotherapy are then allocated to recieve standard dose and schedule radiotherapy.
chemotherapy: Chemotherapy for three cycles prior to radiotherapy
radiotherapy: Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders."
158820|NCT01525927|P1|Participant Flow|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.
chemotherapy: Chemotherapy for three cycles prior to radiotherapy
Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
158821|NCT01525927|O1|Outcome|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.
chemotherapy: Chemotherapy for three cycles prior to radiotherapy
Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
158822|NCT01525927|E2|Reported Event|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.
chemotherapy: Chemotherapy for three cycles prior to radiotherapy
Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy.
Zero (0) participants analyzed"
158873|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
158823|NCT01525927|E1|Reported Event|Chemotherapy Non-responders|"Patients treated with three cycles neoadjuvant chemotherapy who do not exhibit response to chemotherapy are then allocated to recieve standard dose and schedule radiotherapy.
chemotherapy: Chemotherapy for three cycles prior to radiotherapy
radiotherapy: Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders.
Zero (0) participants analyzed"
158824|NCT01525849|B3|Baseline|Total|Total of all reporting groups
158825|NCT01525849|B2|Baseline|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
158826|NCT01525849|B1|Baseline|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
158827|NCT01525849|P2|Participant Flow|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
158828|NCT01525849|P1|Participant Flow|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
158829|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
158830|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
158831|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
158832|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
158833|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
158834|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
158835|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
158836|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
158837|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
158838|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
158839|NCT01525849|E2|Reported Event|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
158840|NCT01525849|E1|Reported Event|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
158841|NCT01525745|B3|Baseline|Total|Total of all reporting groups
158842|NCT01525745|B2|Baseline|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
158843|NCT01525745|B1|Baseline|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
158844|NCT01525745|P2|Participant Flow|External Beam Radiation Therapy|"External Beam Radiation Therapy
External Beam Radiation Therapy: 10 consecutive days of standard radiation"
158845|NCT01525745|P1|Participant Flow|Radiosurgery/SBRT|"Radiosurgery/SBRT
Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments"
158846|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
158847|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
158848|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
158849|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
158850|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
158851|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
158852|NCT01525745|O2|Outcome|External Beam Radiation Therapy|"External Beam Radiation Therapy
External Beam Radiation Therapy: 10 consecutive days of standard radiation"
158853|NCT01525745|O1|Outcome|Radiosurgery/SBRT|"Radiosurgery/SBRT
Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments"
158854|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
191327|NCT01405794|O2|Outcome|32ppm Oral Silver|
158856|NCT01525745|E2|Reported Event|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
158857|NCT01525745|E1|Reported Event|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
158858|NCT01525667|B4|Baseline|Total|Total of all reporting groups
158859|NCT01525667|B3|Baseline|Placebo|Placebo: Single treatment, multiple injections
158860|NCT01525667|B2|Baseline|PLX-PAD High Dose|PLX-PAD high dose: Single treatment, multiple injections
158861|NCT01525667|B1|Baseline|PLX-PAD Low Dose|PLX-PAD low dose: Single treatment, multiple injections
158862|NCT01525667|P3|Participant Flow|Placebo|Placebo: Single treatment, multiple injections
158863|NCT01525667|P2|Participant Flow|PLX-PAD High Dose|300M PLX-PAD : Single treatment, multiple injections
158864|NCT01525667|P1|Participant Flow|PLX-PAD Low Dose|150M PLX-PAD : Single treatment, multiple injections
158865|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
158866|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
158867|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
158868|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
158869|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
158870|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
158874|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
158875|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
158876|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
158877|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
158878|NCT01525667|O2|Outcome|PLX-PAD High Dose|PLX-PAD high dose: Single treatment, multiple injections
158879|NCT01525667|O1|Outcome|PLX-PAD Low Dose|PLX-PAD low dose: Single treatment, multiple injections
158880|NCT01525667|E3|Reported Event|Placebo|Placebo: Single treatment, multiple injections
158881|NCT01525667|E2|Reported Event|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
158882|NCT01525667|E1|Reported Event|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
158883|NCT01525641|B1|Baseline|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
158884|NCT01525641|P1|Participant Flow|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
158885|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
158886|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
158887|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
158888|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
158889|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
159165|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
158890|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
158891|NCT01525641|E1|Reported Event|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
158892|NCT01525628|B6|Baseline|Total|Total of all reporting groups
158893|NCT01525628|B5|Baseline|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
158894|NCT01525628|B4|Baseline|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
158968|NCT01525615|B1|Baseline|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
158895|NCT01525628|B3|Baseline|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
158896|NCT01525628|B2|Baseline|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158897|NCT01525628|B1|Baseline|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158898|NCT01525628|P5|Participant Flow|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
158899|NCT01525628|P4|Participant Flow|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
158900|NCT01525628|P3|Participant Flow|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
158901|NCT01525628|P2|Participant Flow|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158902|NCT01525628|P1|Participant Flow|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158903|NCT01525628|O5|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
158904|NCT01525628|O4|Outcome|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
158905|NCT01525628|O3|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
158906|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158907|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
191328|NCT01405794|O1|Outcome|Placebo|
158908|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
158909|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
158910|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
158911|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
158912|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
158913|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
158969|NCT01525615|P3|Participant Flow|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158914|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158915|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158916|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158917|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158918|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158919|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158920|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158921|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158922|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158923|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158995|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
158924|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158925|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158970|NCT01525615|P2|Participant Flow|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158971|NCT01525615|P1|Participant Flow|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
158926|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158927|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158928|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158929|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158930|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158931|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158932|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158933|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158934|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158935|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158936|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
191329|NCT01405794|O2|Outcome|32ppm Oral Silver|
158937|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158938|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158939|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158940|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158941|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158942|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158943|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158944|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158945|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158946|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158947|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158948|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158949|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
191330|NCT01405794|O1|Outcome|Placebo|
158950|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158951|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158952|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158953|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158954|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158955|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158956|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158957|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158958|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158959|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158960|NCT01525628|E5|Reported Event|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
158961|NCT01525628|E4|Reported Event|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
158962|NCT01525628|E3|Reported Event|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
158963|NCT01525628|E2|Reported Event|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158996|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158964|NCT01525628|E1|Reported Event|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
158965|NCT01525615|B4|Baseline|Total|Total of all reporting groups
158966|NCT01525615|B3|Baseline|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158967|NCT01525615|B2|Baseline|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158972|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158973|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158974|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
158975|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158976|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158977|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
158978|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158979|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158980|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
158981|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158982|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158983|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
158984|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158985|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158986|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
158987|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158988|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158989|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
158990|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158991|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158992|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
158993|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158994|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
191331|NCT01405794|O2|Outcome|32ppm Oral Silver|
158997|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
158998|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
158999|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
159000|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
159001|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
159002|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
159003|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
159004|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
159005|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
159006|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
159007|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
159008|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
159009|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
159010|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat
placebo to tiotropium+olodaterol: comparator"
159011|NCT01525615|E3|Reported Event|Tio+Olo 5.0 / 5.0 μg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
159012|NCT01525615|E2|Reported Event|Tio+Olo 2.5 / 5.0 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
159013|NCT01525615|E1|Reported Event|Placebo|once daily 2 puffs, solution for inhalation Respimat placebo to tiotropium+olodaterol: comparator
159014|NCT01525563|B1|Baseline|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
159015|NCT01525563|P1|Participant Flow|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
159016|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
159017|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
159018|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
159019|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
159020|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
159021|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
159022|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
159023|NCT01525563|E1|Reported Event|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
159024|NCT01525550|B3|Baseline|Total|Total of all reporting groups
159025|NCT01525550|B2|Baseline|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159026|NCT01525550|B1|Baseline|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159027|NCT01525550|P2|Participant Flow|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
191332|NCT01405794|O1|Outcome|Placebo|
159028|NCT01525550|P1|Participant Flow|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159029|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159030|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159031|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159032|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159033|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159034|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159035|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159036|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159037|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159038|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159039|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159040|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159041|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159042|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159043|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159044|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159045|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159046|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159047|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159048|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159049|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159158|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159050|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159051|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159052|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159053|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159054|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159055|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159056|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159057|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159058|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159059|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159060|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159061|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159062|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159063|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159064|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159065|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159066|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159067|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159068|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159069|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159070|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159071|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159159|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159072|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159073|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159074|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159075|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159076|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159077|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159078|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159079|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159080|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159081|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159082|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159083|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159084|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159085|NCT01525550|E2|Reported Event|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
159086|NCT01525550|E1|Reported Event|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
159087|NCT01525420|B3|Baseline|Total|Total of all reporting groups
159088|NCT01525420|B2|Baseline|Cognitive Behavioral Therapy (CBT)|"CBT
Cognitive Behavioral Therapy (CBT): ACT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone."
159089|NCT01525420|B1|Baseline|Acceptance & Commitment Therapy (ACT)|"ACT
Acceptance & Commitment Therapy (ACT): This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone."
159090|NCT01525420|P2|Participant Flow|Cognitive Behavioral Therapy (CBT)|"CBT
Cognitive Behavioral Therapy (CBT): CBT
This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone."
159091|NCT01525420|P1|Participant Flow|Acceptance & Commitment Therapy (ACT)|"ACT
Acceptance & Commitment Therapy (ACT): ACT
This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone."
159092|NCT01525420|O2|Outcome|Cognitive Behavioral Therapy (CBT)|"CBT
Cognitive Behavioral Therapy (CBT): CBT"
159093|NCT01525420|O1|Outcome|Acceptance & Commitment Therapy (ACT)|"ACT
Acceptance & Commitment Therapy (ACT): ACT"
159094|NCT01525420|E2|Reported Event|Cognitive Behavioral Therapy (CBT)|"CBT
Cognitive Behavioral Therapy (CBT): CBT"
159095|NCT01525420|E1|Reported Event|Acceptance & Commitment Therapy (ACT)|"ACT
Acceptance & Commitment Therapy (ACT): ACT"
159096|NCT01525407|B3|Baseline|Total|Total of all reporting groups
159097|NCT01525407|B2|Baseline|Patients|Recipients of donor stem cells.
159098|NCT01525407|B1|Baseline|Donors|"Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant
Atorvastatin Calcium: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant"
159099|NCT01525407|P2|Participant Flow|Patients|Recipients of donor stem cells.
159160|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159161|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159100|NCT01525407|P1|Participant Flow|Donors|"Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant
Atorvastatin Calcium: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant"
159101|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
159102|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
159103|NCT01525407|O1|Outcome|Donors|"Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant
Atorvastatin Calcium: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant"
159104|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
159105|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
159106|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
159107|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
159108|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
159109|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
159110|NCT01525407|O1|Outcome|Patients|Recipients of donor stem cells.
159111|NCT01525407|E2|Reported Event|Donor Adverse Events|Donor: SAEs, AEs (≥ grade 2) and UPs will be monitored and recorded from the time the donor starts atorvastatin therapy through the time of discharge from the transplant center after donation of stem cells or 7 days after the discontinuation of the medication, whichever occurs earlier.
159292|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159112|NCT01525407|E1|Reported Event|Patient Adverse Events|Recipient: SAEs and UPs (life-threatening or fatal) will be monitored and recorded from the time the recipient starts conditioning therapy through day 100 or discharge from the center, whichever occurs earlier.
159113|NCT01525238|B4|Baseline|Total|Total of all reporting groups
159114|NCT01525238|B3|Baseline|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159115|NCT01525238|B2|Baseline|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159116|NCT01525238|B1|Baseline|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159117|NCT01525238|P3|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159118|NCT01525238|P2|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159119|NCT01525238|P1|Participant Flow|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159120|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159121|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159122|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159123|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159124|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159125|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159126|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159127|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159128|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159129|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159130|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159131|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159132|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159133|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159134|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159135|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159136|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159137|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159138|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159139|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159140|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159141|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159142|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159143|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159144|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159145|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159146|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159147|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159148|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159149|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159150|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159151|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159152|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159153|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159154|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159155|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159156|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159157|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159166|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159167|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159168|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159169|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159170|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159171|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159172|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159173|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159174|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159175|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159176|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159177|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159178|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159179|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159180|NCT01525238|E3|Reported Event|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
159181|NCT01525238|E2|Reported Event|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
159182|NCT01525238|E1|Reported Event|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
159183|NCT01525225|B1|Baseline|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
159184|NCT01525225|P1|Participant Flow|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® immediate release (IR) tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
159185|NCT01525225|O1|Outcome|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
159186|NCT01525225|O1|Outcome|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
159187|NCT01525225|E1|Reported Event|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
159188|NCT01525173|B3|Baseline|Total|Total of all reporting groups
159189|NCT01525173|B2|Baseline|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
159190|NCT01525173|B1|Baseline|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
159191|NCT01525173|P2|Participant Flow|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
159192|NCT01525173|P1|Participant Flow|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
159193|NCT01525173|O2|Outcome|LUMIGAN® Alone|1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
159194|NCT01525173|O1|Outcome|ALPHAGAN® P and LUMIGAN®|1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
159195|NCT01525173|E2|Reported Event|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
159196|NCT01525173|E1|Reported Event|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
159197|NCT01524913|B4|Baseline|Total|Total of all reporting groups
159198|NCT01524913|B3|Baseline|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
159199|NCT01524913|B2|Baseline|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
159200|NCT01524913|B1|Baseline|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
159201|NCT01524913|P3|Participant Flow|Saline Placebo|Participants in this group received 1 milliliter (mL) of lactated Ringer's solution injected into the superior joint space.
159202|NCT01524913|P2|Participant Flow|Hyaluronic Acid|Participants in the group received 1milliliter (mL) of Hyalgan (10 mg/mL) injected into the superior joint space.
159203|NCT01524913|P1|Participant Flow|Corticosteroid|Participants in this group received 1 milliliter (mL) of Celestone (6mg/mL) injected into the the superior joint space.
159204|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
159205|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
159206|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
159207|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
159208|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
161630|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
159209|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
159210|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
159211|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
159212|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
159213|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
159214|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
159215|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
159216|NCT01524913|E3|Reported Event|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
159217|NCT01524913|E2|Reported Event|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
159218|NCT01524913|E1|Reported Event|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
159219|NCT01524900|B6|Baseline|Total|Total of all reporting groups
159220|NCT01524900|B5|Baseline|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
159221|NCT01524900|B4|Baseline|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
159222|NCT01524900|B3|Baseline|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
159223|NCT01524900|B2|Baseline|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
159224|NCT01524900|B1|Baseline|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
159225|NCT01524900|P5|Participant Flow|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
159226|NCT01524900|P4|Participant Flow|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
159227|NCT01524900|P3|Participant Flow|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
159228|NCT01524900|P2|Participant Flow|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
159229|NCT01524900|P1|Participant Flow|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
159230|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
159231|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
159232|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
159233|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
159234|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
159235|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
159236|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
159237|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
159238|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
159239|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
159240|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
159241|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
159242|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
159243|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
159244|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
159245|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
159246|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
159247|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
159248|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
159249|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
159250|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
159251|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
159252|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
159253|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
159254|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
159255|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
159256|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
159257|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
159258|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
159259|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
159260|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
159261|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
159262|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
159263|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
159264|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
159265|NCT01524900|E5|Reported Event|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
159266|NCT01524900|E4|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/ML|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
159267|NCT01524900|E3|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/ML|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
159268|NCT01524900|E2|Reported Event|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
159269|NCT01524900|E1|Reported Event|Treatment-naïve Patients|Patients who were not pretreated with HIV therapy
159270|NCT01524887|B4|Baseline|Total|Total of all reporting groups
159271|NCT01524887|B3|Baseline|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159272|NCT01524887|B2|Baseline|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159273|NCT01524887|B1|Baseline|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159274|NCT01524887|P3|Participant Flow|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159275|NCT01524887|P2|Participant Flow|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159276|NCT01524887|P1|Participant Flow|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159277|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159278|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159279|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159280|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159281|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159282|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159283|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159284|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159285|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159286|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159287|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159288|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159289|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159290|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159291|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159293|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159294|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159295|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159296|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159297|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159298|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159299|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159300|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159301|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159302|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159303|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159304|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159305|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159306|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159307|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159308|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159309|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159310|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159311|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159312|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159313|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159314|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159315|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159316|NCT01524887|E3|Reported Event|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
159317|NCT01524887|E2|Reported Event|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159318|NCT01524887|E1|Reported Event|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
159319|NCT01524796|B1|Baseline|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159320|NCT01524796|P1|Participant Flow|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159321|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159322|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159394|NCT01524302|E2|Reported Event|Ceftaroline|"Pharmacodynamics
Ceftaroline: 600 mg Q12h"
159323|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159324|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159325|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159326|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159327|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159328|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159329|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159330|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159331|NCT01524796|E1|Reported Event|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
159332|NCT01524783|B3|Baseline|Total|Total of all reporting groups
159333|NCT01524783|B2|Baseline|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
159334|NCT01524783|B1|Baseline|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
159335|NCT01524783|P2|Participant Flow|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
159336|NCT01524783|P1|Participant Flow|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
159337|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
159338|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
159339|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
159340|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
159341|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
159342|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
159343|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
159344|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
159345|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
159346|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
159347|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
159348|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
159349|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
159350|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
159351|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
159352|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
159353|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
159354|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
159355|NCT01524783|E2|Reported Event|Placebo + BSC|Placebo + BSC
159356|NCT01524783|E1|Reported Event|Everolimus + BSC|Everolimus + BSC
159357|NCT01524770|B1|Baseline|Entire Study Population|All participants who received at least one 1.5-milligram (mg) dose of dulaglutide administered subcutaneously via manual syringe or auto-injector.
159358|NCT01524770|P2|Participant Flow|Auto-injector First, Then Manual Syringe|"First Intervention:
Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector.
There was a washout period of at least 28 days between treatment periods.
Second intervention:
Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by manual syringe."
191333|NCT01405794|O2|Outcome|32ppm Oral Silver|
159359|NCT01524770|P1|Participant Flow|Manual Syringe First, Then Auto-injector|"First Intervention:
Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe.
There was a washout period of at least 28 days between treatment periods.
Second intervention:
Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by auto-injector."
159360|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
159361|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
159362|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
159363|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
159364|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
159365|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
159447|NCT01523756|E2|Reported Event|Test Product 2|"own product (baseline) - test product 2 - test product 1
test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
159366|NCT01524770|E2|Reported Event|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
159367|NCT01524770|E1|Reported Event|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period
159368|NCT01524627|B3|Baseline|Total|Total of all reporting groups
159369|NCT01524627|B2|Baseline|Varenicline|"Subjects will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
159370|NCT01524627|B1|Baseline|Placebo|"Participants will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
159371|NCT01524627|P2|Participant Flow|Varenicline|Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
159372|NCT01524627|P1|Participant Flow|Placebo|Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective as Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
159373|NCT01524627|O2|Outcome|Varenicline|"Subjects will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
159374|NCT01524627|O1|Outcome|Placebo|"Participants will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
159375|NCT01524627|E2|Reported Event|Varenicline|"Subjects will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
159376|NCT01524627|E1|Reported Event|Placebo|"Participants will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks."
159377|NCT01524302|B3|Baseline|Total|Total of all reporting groups
159378|NCT01524302|B2|Baseline|Ceftaroline|"Pharmacodynamics
Ceftaroline: 600 mg Q12h"
159379|NCT01524302|B1|Baseline|Levofloxacin|"Pharmacodynamics
Levofloxacin: 750 mg QD"
159380|NCT01524302|P2|Participant Flow|Ceftaroline|"Pharmacodynamics
Ceftaroline: 600 mg Q12h"
159381|NCT01524302|P1|Participant Flow|Levofloxacin|"Pharmacodynamics
Levofloxacin: 750 mg QD"
159382|NCT01524302|O4|Outcome|Log Inhibition of 4.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
159383|NCT01524302|O3|Outcome|Log Inhibition of 2.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
159384|NCT01524302|O2|Outcome|Log Inhibition of 1.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
159385|NCT01524302|O1|Outcome|Log Inhibition of 0.5mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
159386|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics
Ceftaroline: 600 mg Q12h"
159387|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics
Levofloxacin: 750 mg QD"
159388|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics
Ceftaroline: 600 mg Q12h"
159389|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics
Levofloxacin: 750 mg QD"
159390|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics
Ceftaroline: 600 mg Q12h"
159391|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics
Levofloxacin: 750 mg QD"
159392|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics
Ceftaroline: 600 mg Q12h"
159393|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics
Levofloxacin: 750 mg QD"
159395|NCT01524302|E1|Reported Event|Levofloxacin|"Pharmacodynamics
Levofloxacin: 750 mg QD"
159396|NCT01524198|B3|Baseline|Total|Total of all reporting groups
159397|NCT01524198|B2|Baseline|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
159398|NCT01524198|B1|Baseline|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
159399|NCT01524198|P2|Participant Flow|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
159400|NCT01524198|P1|Participant Flow|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
159401|NCT01524198|O2|Outcome|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
159477|NCT01523457|B3|Baseline|Total|Total of all reporting groups
159402|NCT01524198|O1|Outcome|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
159403|NCT01524198|O2|Outcome|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
159404|NCT01524198|O1|Outcome|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
159405|NCT01524198|E2|Reported Event|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
159406|NCT01524198|E1|Reported Event|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
159407|NCT01523964|B5|Baseline|Total|Total of all reporting groups
159408|NCT01523964|B4|Baseline|Healthy Control Ages 8-12 Inclusive|
159409|NCT01523964|B3|Baseline|Healthy Control Ages 3-7 Inclusive|
159410|NCT01523964|B2|Baseline|DMD Subject Ages 8-12 Inclusive|
159411|NCT01523964|B1|Baseline|DMD Subject Ages 3-7 Inclusive|
159412|NCT01523964|P4|Participant Flow|Healthy Control Ages 8-12 Inclusive|
159413|NCT01523964|P3|Participant Flow|Healthy Control Ages 3-7 Inclusive|
159414|NCT01523964|P2|Participant Flow|DMD Subject Ages 8-12 Inclusive|
159415|NCT01523964|P1|Participant Flow|DMD Subject Ages 3-7 Inclusive|
159416|NCT01523964|O4|Outcome|Healthy Control Ages 8-12 Inclusive|
159417|NCT01523964|O3|Outcome|Healthy Control Ages 3-7 Inclusive|
159418|NCT01523964|O2|Outcome|DMD Subject Ages 8-12 Inclusive|
159419|NCT01523964|O1|Outcome|DMD Subject Ages 3-7 Inclusive|
159420|NCT01523964|E4|Reported Event|Healthy Control Ages 8-12 Inclusive|
159421|NCT01523964|E3|Reported Event|Healthy Control Ages 3-7 Inclusive|
159422|NCT01523964|E2|Reported Event|DMD Subject Ages 8-12 Inclusive|
159423|NCT01523964|E1|Reported Event|DMD Subject Ages 3-7 Inclusive|
159424|NCT01523886|B3|Baseline|Total|Total of all reporting groups
159425|NCT01523886|B2|Baseline|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
159426|NCT01523886|B1|Baseline|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
159427|NCT01523886|P2|Participant Flow|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
159428|NCT01523886|P1|Participant Flow|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
159429|NCT01523886|O2|Outcome|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
159430|NCT01523886|O1|Outcome|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
159431|NCT01523886|E2|Reported Event|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
159432|NCT01523886|E1|Reported Event|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
159433|NCT01523873|B1|Baseline|All Included Patients|All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported.
159434|NCT01523873|P1|Participant Flow|All Included Patients|All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported.
159435|NCT01523873|O1|Outcome|Efficacy Population|Efficacy Population included all patients administered with Dotarem who have been imaged and have had a valid diagnostic assessment.
159436|NCT01523873|O1|Outcome|Efficacy Population|Efficacy Population included all patients administered with Dotarem who have been imaged and have had a valid diagnostic assessment.
159437|NCT01523873|O1|Outcome|Patients With Moderate to Severe Impaired Renal Function|Patients identified with moderate to severe impaired renal function at the time of inclusion (i.e. estimated Glomerular Filtration Rate (eGFR) or estimated creatinine clearance (eCrCl) <60 ml/min (1.73 m2))
159438|NCT01523873|O1|Outcome|Safety Population|Safety Population included All Included Patients administered with Dotarem.
159986|NCT01521546|E1|Reported Event|Placebo|placebo one tablet daily for 12 months
159439|NCT01523873|E1|Reported Event|Safety Population|Safety Population included All Included Patients administered with Dotarem.
159440|NCT01523756|B1|Baseline|Overall Study|
159441|NCT01523756|P2|Participant Flow|Own Product (Baseline) - Test Product 2 - Test Product 1|"own product (baseline) - test product 2 - test product 1
test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
159442|NCT01523756|P1|Participant Flow|Own Product (Baseline) - Test Product 1 - Test Product 2|"own product (baseline) - test product 1 - test product 2
test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
159443|NCT01523756|O3|Outcome|Baseline|"Data collected on own product-
All subjects collected baseline data on own product in the first period."
159444|NCT01523756|O2|Outcome|Test Product 2|"own product (baseline) - test product 2 - test product 1
test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
159445|NCT01523756|O1|Outcome|Test Product 1|"own product (baseline) - test product 1 - test product 2
test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
159446|NCT01523756|E3|Reported Event|Baseline|"Data collected on own product-
All subjects collected baseline data on own product in the first period."
159506|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159448|NCT01523756|E1|Reported Event|Test Product 1|"own product (baseline) - test product 1 - test product 2
test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
159449|NCT01523743|B1|Baseline|All Study Participants|"125 subjects were randomized in this study, however 7 subjects discontinued only providing baseline data and were therefore excluded from the ITT population as they did not contribute with any endpoint data.
The baseline and analysis data are based on the ITT population."
159450|NCT01523743|P2|Participant Flow|First Standard Care; Then Compact Catheter|First period: Standard Care: Coated intermittent catheter normally used by subject Second period: Compact catheter: Compact intermittent catheter from Coloplast
159451|NCT01523743|P1|Participant Flow|First Compact Catheter, Then Standard Care|First period: Compact intermittent catheter from Coloplast. Second period: Standard Care: Coated intermittent catheter normally used by subject
159452|NCT01523743|O2|Outcome|Standard Care|Standard Care: Coated intermittent catheter normally used by subject
159453|NCT01523743|O1|Outcome|Compact Catheter|Compact intermittent catheter
159454|NCT01523743|E2|Reported Event|Standard Care|Standard Care: Coated intermittent catheter normally used by subject
159455|NCT01523743|E1|Reported Event|Compact Catheter|Compact intermittent catheter
159456|NCT01523587|B3|Baseline|Total|Total of all reporting groups
159457|NCT01523587|B2|Baseline|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
159458|NCT01523587|B1|Baseline|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
159459|NCT01523587|P2|Participant Flow|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
159460|NCT01523587|P1|Participant Flow|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
159461|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
159462|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
159463|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
159464|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
159465|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
159466|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
159467|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
159468|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
159469|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
159470|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
159471|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
159472|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
159473|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
159474|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
159475|NCT01523587|E2|Reported Event|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
159476|NCT01523587|E1|Reported Event|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
159478|NCT01523457|B2|Baseline|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159479|NCT01523457|B1|Baseline|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159480|NCT01523457|P2|Participant Flow|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159481|NCT01523457|P1|Participant Flow|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159482|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159483|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159484|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159485|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159941|NCT01521780|P2|Participant Flow|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
159486|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159487|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159507|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
159508|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159509|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
159488|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159489|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159490|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159491|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159492|NCT01523457|O2|Outcome|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159493|NCT01523457|O1|Outcome|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159494|NCT01523457|E2|Reported Event|LAPC Modified FOLFIRINOX|Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159495|NCT01523457|E1|Reported Event|MPC Modified FOLFIRINOX|Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
159496|NCT01523392|B3|Baseline|Total|Total of all reporting groups
159497|NCT01523392|B2|Baseline|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)
159498|NCT01523392|B1|Baseline|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 2)
159499|NCT01523392|P2|Participant Flow|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)
159500|NCT01523392|P1|Participant Flow|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2)
159501|NCT01523392|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159502|NCT01523392|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159503|NCT01523392|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159504|NCT01523392|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159505|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
159510|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159511|NCT01523392|E2|Reported Event|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
159512|NCT01523392|E1|Reported Event|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159513|NCT01523366|B3|Baseline|Total|Total of all reporting groups
159514|NCT01523366|B2|Baseline|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
159515|NCT01523366|B1|Baseline|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
159516|NCT01523366|P2|Participant Flow|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
159517|NCT01523366|P1|Participant Flow|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
159518|NCT01523366|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159519|NCT01523366|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159520|NCT01523366|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159521|NCT01523366|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
159522|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
159523|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
159524|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
159525|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
159526|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
159527|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
159528|NCT01523366|E2|Reported Event|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
159529|NCT01523366|E1|Reported Event|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
159530|NCT01523301|B3|Baseline|Total Title|
159531|NCT01523301|B2|Baseline|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.
Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.
Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.
All subjects remained 8-weeks in the Maintenance Period.
In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.
A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
159532|NCT01523301|B1|Baseline|Rotigotine|"Rotigotine, daily doses, treatment Group.
Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.
Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.
All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.
A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
159571|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV"
159574|NCT01522976|E2|Reported Event|Arm 2: Azacitidine|Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
159533|NCT01523301|P2|Participant Flow|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.
Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.
Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.
All subjects remained 8-weeks in the Maintenance Period.
In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.
A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
159534|NCT01523301|P1|Participant Flow|Rotigotine|"Rotigotine, daily doses, treatment Group.
Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.
Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.
All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.
A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
159551|NCT01522976|B4|Baseline|Total|Total of all reporting groups
159535|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159536|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159537|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159538|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159539|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159540|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159541|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159542|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159543|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159544|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159545|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159546|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159547|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159548|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
159572|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Lenalidomide: Given PO"
159573|NCT01522976|E3|Reported Event|Arm 3: Azacitidine/Vorinostat|Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
191334|NCT01405794|O1|Outcome|Placebo|
159549|NCT01523301|E2|Reported Event|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.
Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.
Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.
All subjects remained 8-weeks in the Maintenance Period.
In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.
A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
159550|NCT01523301|E1|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment Group.
Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.
Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.
All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.
A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
159552|NCT01522976|B3|Baseline|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO"
159553|NCT01522976|B2|Baseline|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV"
159554|NCT01522976|B1|Baseline|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Lenalidomide: Given PO"
159555|NCT01522976|P3|Participant Flow|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO"
159556|NCT01522976|P2|Participant Flow|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV"
159557|NCT01522976|P1|Participant Flow|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Lenalidomide: Given PO"
159558|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
159559|NCT01522976|O2|Outcome|Arm 2: Azacitidine|Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
159560|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
159561|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO"
159562|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV"
159563|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Lenalidomide: Given PO"
159564|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO"
159565|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV"
159566|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Lenalidomide: Given PO"
159567|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO"
159568|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV"
159569|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Lenalidomide: Given PO"
159570|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Vorinostat: Given PO"
159983|NCT01521546|O2|Outcome|Eplerenone|eplerenone one tablet by mouth daily for 12 months
159575|NCT01522976|E1|Reported Event|Arm 1: Azacitidine/Lenalidomide|Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
159576|NCT01522963|B5|Baseline|Total|Total of all reporting groups
159577|NCT01522963|B4|Baseline|Nicotine Lozenge 30 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159578|NCT01522963|B3|Baseline|Nicotine Lozenge 20 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159579|NCT01522963|B2|Baseline|Nicotine Lozenge 10 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159580|NCT01522963|B1|Baseline|Nicotine Lozenge Immediately Prior to Stress Task.|Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159581|NCT01522963|P4|Participant Flow|Nicotine Lozenge 30 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159631|NCT01522703|E2|Reported Event|Alfalfa Sprouts (Placebo Control)|
159582|NCT01522963|P3|Participant Flow|Nicotine Lozenge 20 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159583|NCT01522963|P2|Participant Flow|Nicotine Lozenge 10 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159584|NCT01522963|P1|Participant Flow|Nicotine Lozenge Immediately Prior to Stress Task.|Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159585|NCT01522963|O4|Outcome|Nicotine Lozenge 30 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159586|NCT01522963|O3|Outcome|Nicotine Lozenge 20 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159587|NCT01522963|O2|Outcome|Nicotine Lozenge 10 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159588|NCT01522963|O1|Outcome|Nicotine Lozenge Immediately Prior to Stress Task.|Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159589|NCT01522963|O4|Outcome|Nicotine Lozenge 30 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159590|NCT01522963|O3|Outcome|Nicotine Lozenge 20 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159591|NCT01522963|O2|Outcome|Nicotine Lozenge 10 Min Prior to Stress Task|Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159592|NCT01522963|O1|Outcome|Nicotine Lozenge Immediately Prior to Stress Task.|Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
159593|NCT01522963|E2|Reported Event|Nicotine Lozenge After Stress Task|"Subjects will receive the nicotine lozenge after the stress task during the first laboratory session and prior to the stress task at the second laboratory session
Nicotine lozenge 4 mg: A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task"
159594|NCT01522963|E1|Reported Event|Nicotine Lozenge Prior to Stress Task|"Subjects will receive the nicotine lozenge at one of four time-points prior to the stress task at the first laboratory session and after the stress task at the second laboratory session
Nicotine lozenge 4 mg: A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task"
159595|NCT01522937|B1|Baseline|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).
individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
159596|NCT01522937|P1|Participant Flow|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).
individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
159597|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).
individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
159987|NCT01521507|B3|Baseline|Total|Total of all reporting groups
159598|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).
individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
159599|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).
individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
159632|NCT01522703|E1|Reported Event|Broccoli Sprouts|
159950|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
159600|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).
individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
159601|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).
individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
159602|NCT01522937|E1|Reported Event|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).
individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
159603|NCT01522924|B3|Baseline|Total|Total of all reporting groups
159604|NCT01522924|B2|Baseline|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
159605|NCT01522924|B1|Baseline|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
159606|NCT01522924|P2|Participant Flow|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
159607|NCT01522924|P1|Participant Flow|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
159608|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
159609|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
159610|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
159611|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
159612|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
159613|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
159614|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
159615|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
159616|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
159617|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
159618|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
159619|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
159620|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
159621|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
159622|NCT01522924|E2|Reported Event|Counseling/Debriefing|participated in counseling and debriefing sessions
159623|NCT01522924|E1|Reported Event|Lecture Only|participated in lecture only
159624|NCT01522703|B3|Baseline|Total|Total of all reporting groups
159625|NCT01522703|B2|Baseline|Alfalfa Sprouts (Placebo Control)|
159626|NCT01522703|B1|Baseline|Broccoli Sprouts|
159627|NCT01522703|P2|Participant Flow|Alfalfa Sprouts (Placebo Control)|ingestion of alfalfa sprouts 3 consecutive days
159628|NCT01522703|P1|Participant Flow|Broccoli Sprouts|ingestion of broccoli sprouts 3 consecutive days
159629|NCT01522703|O2|Outcome|Broccoli Sprouts|ingestion of broccoli sprouts for 3 consecutive days
159630|NCT01522703|O1|Outcome|Alfalfa Sprouts (Placebo Control)|ingestion of alfalfa sprouts for 3 consecutive days
159633|NCT01522456|B1|Baseline|Total Participants|All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
159634|NCT01522456|P1|Participant Flow|Total Participants|All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
159635|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159636|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159637|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159638|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159639|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159640|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159641|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159642|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159643|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159644|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159645|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159646|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159647|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159648|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159649|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159650|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159651|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159652|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159653|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159654|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159655|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159656|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159657|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
191335|NCT01405794|O2|Outcome|32ppm Oral Silver|
159658|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159659|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159660|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159661|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159662|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159663|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159664|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159951|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
159665|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159666|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159667|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159668|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159669|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159670|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159671|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159672|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159673|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159674|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159675|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159676|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159677|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159678|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159679|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159680|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159681|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159682|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159683|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159684|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159685|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159686|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159687|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159688|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159689|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
159690|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159691|NCT01522456|E3|Reported Event|Non-application Site|Adverse events occurring on non-application sites
159692|NCT01522456|E2|Reported Event|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%
Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
191336|NCT01405794|O1|Outcome|Placebo|
159693|NCT01522456|E1|Reported Event|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel
Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
159694|NCT01522339|B1|Baseline|Pilot Group|Patients who had an MRI in the NICU scanner.
159695|NCT01522339|P1|Participant Flow|Pilot Group|Patients who received an MRI.
159696|NCT01522339|O1|Outcome|Pilot Group|Patients who had an MRI on the NICU scanner.
159697|NCT01522339|O1|Outcome|Pilot Group|Patients who received an MRI on the NICU scanner.
159698|NCT01522339|E1|Reported Event|Pilot Group|Patients who had an MRI in the NICU scanner.
159699|NCT01522235|B3|Baseline|Total|Total of all reporting groups
159700|NCT01522235|B2|Baseline|Group B|"Placebo
2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159952|NCT01521780|O1|Outcome|Imaging and Imaging/Pathology|Magnetic resonance imaging (MRI) of HCC tumor.
159701|NCT01522235|B1|Baseline|Group A|"IVIg
IVIG: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159702|NCT01522235|P2|Participant Flow|Placebo Group|"Placebo
2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period."
159703|NCT01522235|P1|Participant Flow|IVIG Group|"IVIg
IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period."
159704|NCT01522235|O2|Outcome|Group B|"Placebo
2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159705|NCT01522235|O1|Outcome|Group A|"IVIg
IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159706|NCT01522235|O2|Outcome|Placebo Group|"Placebo
2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159707|NCT01522235|O1|Outcome|IVIg Group|"IVIg
IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159708|NCT01522235|O2|Outcome|Placebo Group|"Placebo
2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159709|NCT01522235|O1|Outcome|IVIg Group|"IVIg
IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159710|NCT01522235|O2|Outcome|Placebo Group|"Placebo
2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159711|NCT01522235|O1|Outcome|IVIg Group|"IVIg
IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159712|NCT01522235|O2|Outcome|Placebo Group|"Placebo
2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
191337|NCT01405794|O2|Outcome|32ppm Oral Silver|
159713|NCT01522235|O1|Outcome|IVIG Group|"IVIg
IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159714|NCT01522235|O2|Outcome|Placebo Group|"Placebo
2 treatments of placebo and 2 treatments of IVIG: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159742|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159715|NCT01522235|O1|Outcome|IVIg Group|"IVIg
IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159716|NCT01522235|E2|Reported Event|Placebo Group|"Placebo
2 treatments of placebo and 2 treatments of IVIg: Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159717|NCT01522235|E1|Reported Event|IVIg Group|"IVIg
IVIg: Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
They will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later."
159718|NCT01522131|B3|Baseline|Total|Total of all reporting groups
159719|NCT01522131|B2|Baseline|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
159720|NCT01522131|B1|Baseline|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)
bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
159721|NCT01522131|P2|Participant Flow|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
159722|NCT01522131|P1|Participant Flow|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)
bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
159723|NCT01522131|O2|Outcome|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
159724|NCT01522131|O1|Outcome|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)
bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
159725|NCT01522131|O2|Outcome|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
159726|NCT01522131|O1|Outcome|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)
bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
159727|NCT01522131|E2|Reported Event|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
159728|NCT01522131|E1|Reported Event|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)
bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
159729|NCT01521923|B5|Baseline|Total Title|
159730|NCT01521923|B4|Baseline|CZP+MTX / CZP Q2W+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2
159731|NCT01521923|B3|Baseline|CZP+MTX / CZP Q4W+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2
159732|NCT01521923|B2|Baseline|CZP+MTX / PBO+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2
159733|NCT01521923|B1|Baseline|PBO+MTX / PBO+MTX|Placebo (PBO) + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2
159734|NCT01521923|P4|Participant Flow|CZP+MTX / CZP Q2W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159735|NCT01521923|P3|Participant Flow|CZP+MTX / CZP Q4W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159736|NCT01521923|P2|Participant Flow|CZP+MTX / PBO+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159737|NCT01521923|P1|Participant Flow|PBO+MTX / PBO+MTX|"Placebo (PBO) + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159984|NCT01521546|O1|Outcome|Placebo|placebo: one tablet by mouth daily for 12 months
159738|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159739|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159740|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159741|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159743|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159744|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159745|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159746|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159747|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159748|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159749|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159750|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159751|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159752|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159753|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159754|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159755|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159756|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159757|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159758|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159759|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159760|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159761|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159762|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159763|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159764|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159765|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159766|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
191338|NCT01405794|O1|Outcome|Placebo|
159767|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159768|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159769|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159770|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159771|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159948|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
159772|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159773|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159774|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159775|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159776|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159777|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159778|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159779|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159780|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159781|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159782|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159783|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159784|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159785|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159786|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159787|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159788|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159789|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159790|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159791|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159792|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159793|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159794|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159795|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159854|NCT01521923|E2|Reported Event|CZP+MTX / PBO+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159796|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159797|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159798|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159799|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159953|NCT01521780|O1|Outcome|Imaging and Imaging/Pathology|Magnetic resonance imaging (MRI) of HCC tumor.
159800|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159801|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159802|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159803|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159804|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159805|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159806|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159807|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159808|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159809|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159810|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159811|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159812|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159813|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159814|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159815|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159816|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159817|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159818|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159819|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159820|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159821|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159822|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159823|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159824|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159938|NCT01521845|E1|Reported Event|Omega 3|receive omega 3 in addition to standard treatment
159825|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159826|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159827|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159828|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
162480|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
159829|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159830|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159831|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159832|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159833|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159834|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159835|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159836|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159837|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159838|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159839|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159840|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159841|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159842|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159843|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159844|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159845|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159846|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159847|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159848|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159849|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159850|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159851|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set [FAS])|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159852|NCT01521923|E4|Reported Event|CZP+MTX / CZP Q2W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
159853|NCT01521923|E3|Reported Event|CZP+MTX / CZP Q4W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1
1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
159939|NCT01521780|B1|Baseline|All Participants|Participants who enrolled in the study
159855|NCT01521923|E1|Reported Event|PBO+MTX / PBO+MTX|"Placebo (PBO) + Methotrexate (MTX) in Period 1
1 syringe PBO every 2 Weeks + MTX in Period 2"
159856|NCT01521897|B1|Baseline|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159857|NCT01521897|P1|Participant Flow|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159858|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159859|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159860|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159861|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159862|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159863|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159864|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159865|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159866|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159867|NCT01521897|E1|Reported Event|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
159868|NCT01521884|B1|Baseline|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159869|NCT01521884|P1|Participant Flow|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159870|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159871|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159872|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159873|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159874|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159940|NCT01521780|P3|Participant Flow|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
159875|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159876|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159877|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159878|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159879|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159880|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159881|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159882|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159883|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159884|NCT01521884|E1|Reported Event|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
159885|NCT01521871|B3|Baseline|Total|Total of all reporting groups
159886|NCT01521871|B2|Baseline|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
159887|NCT01521871|B1|Baseline|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159888|NCT01521871|P2|Participant Flow|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
159889|NCT01521871|P1|Participant Flow|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159890|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159891|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159892|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159893|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159894|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159895|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159896|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159897|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159898|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159899|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159900|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159901|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159985|NCT01521546|E2|Reported Event|Eplerenone|eplerenone one tablet daily for 12 months
159902|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159903|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159904|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159949|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
159905|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159906|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159907|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159908|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159909|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159910|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159911|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159912|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159913|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159914|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159915|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159916|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159917|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159918|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159919|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159920|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159921|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159922|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159923|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
159924|NCT01521871|E2|Reported Event|Tissue Glue Wound Closure|"Skin wound closure by tissue glue
Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
159925|NCT01521871|E1|Reported Event|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
159926|NCT01521845|B3|Baseline|Total|Total of all reporting groups
159927|NCT01521845|B2|Baseline|Control|This group is without omega 3 : just receives standard treatment
159928|NCT01521845|B1|Baseline|Omega 3|receive omega 3 in addition to standard treatment
159929|NCT01521845|P2|Participant Flow|Control|This group is without omega 3 : just receives standard treatment
159930|NCT01521845|P1|Participant Flow|Omega 3|receive omega 3 in addition to standard treatment
159931|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
159932|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
159933|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
159934|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
159935|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
159936|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
159937|NCT01521845|E2|Reported Event|Control|This group is without omega 3 : just receives standard treatment
159942|NCT01521780|P1|Participant Flow|Imaging|Magnetic resonance imaging (MRI) of Hepatocellular carcinoma (HCC) tumor.
159943|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
159944|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
159945|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
159946|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
159947|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
159954|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
159955|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
159956|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
159957|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
159958|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
159959|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
159960|NCT01521780|E3|Reported Event|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
159961|NCT01521780|E2|Reported Event|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
159962|NCT01521780|E1|Reported Event|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
159963|NCT01521559|B3|Baseline|Total|Total of all reporting groups
159964|NCT01521559|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
159965|NCT01521559|B1|Baseline|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
159966|NCT01521559|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
159967|NCT01521559|P1|Participant Flow|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
159968|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
159969|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
159970|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24
159971|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
159972|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
159973|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
159974|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
159975|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
159976|NCT01521559|E2|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
159977|NCT01521559|E1|Reported Event|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
159978|NCT01521546|B3|Baseline|Total|Total of all reporting groups
159979|NCT01521546|B2|Baseline|Placebo|"placebo
placebo: one tablet by mouth daily for 12 months"
159980|NCT01521546|B1|Baseline|Eplerenone|"active study drug
eplerenone: 25mg tablet, once daily by mouth for 12 months"
159981|NCT01521546|P2|Participant Flow|Eplerenone|"active study drug
eplerenone: 25mg tablet, once daily by mouth for 12 months"
159982|NCT01521546|P1|Participant Flow|Placebo|"placebo
placebo: one tablet by mouth daily for 12 months"
159988|NCT01521507|B2|Baseline|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
159989|NCT01521507|B1|Baseline|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
159990|NCT01521507|P2|Participant Flow|Warm Compress & Lid Hygiene, Then Crossover LipiFlow Treatment|"Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3 months in Stage 1. Then, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:
One LipiFlow Treatment - After subjects received one LipiFlow treatment at crossover, no other MGD or dry eye treatment was prescribed for the study duration.
Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.
Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician."
160026|NCT01521260|E1|Reported Event|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
159991|NCT01521507|P1|Participant Flow|LipiFlow Treatment|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:
One LipiFlow Treatment - After subjects received one LipiFlow treatment at randomization, no other MGD or dry eye treatment was prescribed for the study duration.
Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.
Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician."
159992|NCT01521507|O4|Outcome|Warm Compress/Hygiene Arm: Combination Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician."
159993|NCT01521507|O3|Outcome|Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
159994|NCT01521507|O2|Outcome|LipiFlow Arm: Combination Treatment Subgroup|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician."
159995|NCT01521507|O1|Outcome|LipiFlow Arm: One LipiFlow Treatment Subgroup|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
159996|NCT01521507|O2|Outcome|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
159997|NCT01521507|O1|Outcome|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
159998|NCT01521507|O4|Outcome|Warm Compress/Hygiene Arm: Combination Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician."
159999|NCT01521507|O3|Outcome|Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
160000|NCT01521507|O2|Outcome|LipiFlow Arm: Combination Treatment Subgroup|"Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician."
160001|NCT01521507|O1|Outcome|LipiFlow Arm: One LipiFlow Treatment Subgroup|"Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
160002|NCT01521507|O2|Outcome|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
160003|NCT01521507|O1|Outcome|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
160004|NCT01521507|E3|Reported Event|Crossover LipiFlow Treatment|After using twice-daily, standardized warm compress therapy and lid hygiene for 3 months, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
160005|NCT01521507|E2|Reported Event|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
160006|NCT01521507|E1|Reported Event|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
160007|NCT01521364|B1|Baseline|Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.
After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.
After this, there is a wash-out period of one week during which no claritromycine is administered.
Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.
At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
160008|NCT01521364|P1|Participant Flow|0mg, 250mg and 500mg Claritromycin|Patients receive 300mg linezolid twice a day during entire study.
160027|NCT01521143|B5|Baseline|Total|Total of all reporting groups
160028|NCT01521143|B4|Baseline|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
160029|NCT01521143|B3|Baseline|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160009|NCT01521364|O3|Outcome|500mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.
After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.
After this, there is a wash-out period of one week during which no claritromycine is administered.
Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.
At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
160010|NCT01521364|O2|Outcome|250mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.
After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.
After this, there is a wash-out period of one week during which no claritromycine is administered.
Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.
At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
160011|NCT01521364|O1|Outcome|0mg Claritromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.
After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.
After this, there is a wash-out period of one week during which no claritromycine is administered.
Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.
At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
160012|NCT01521364|O3|Outcome|500mg Clarithromycin|
160013|NCT01521364|O2|Outcome|250mg Clarithromycin|
160014|NCT01521364|O1|Outcome|0mg Claritrhomycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.
After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.
After this, there is a wash-out period of one week during which no claritromycine is administered.
Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.
At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
160015|NCT01521364|E3|Reported Event|500mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.
After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.
After this, there is a wash-out period of one week during which no claritromycine is administered.
Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.
At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
160016|NCT01521364|E2|Reported Event|250mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.
After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.
After this, there is a wash-out period of one week during which no claritromycine is administered.
Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.
At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
160017|NCT01521364|E1|Reported Event|0mg Claritromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.
After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.
After this, there is a wash-out period of one week during which no claritromycine is administered.
Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.
At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
160018|NCT01521260|B3|Baseline|Total|Total of all reporting groups
160019|NCT01521260|B2|Baseline|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
160020|NCT01521260|B1|Baseline|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
160021|NCT01521260|P2|Participant Flow|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
160022|NCT01521260|P1|Participant Flow|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
160023|NCT01521260|O2|Outcome|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
160096|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
161674|NCT01516437|E1|Reported Event|HNS Group|Healthy non-smokers aged between 45-75 years
160024|NCT01521260|O1|Outcome|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
160025|NCT01521260|E2|Reported Event|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
160030|NCT01521143|B2|Baseline|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
160031|NCT01521143|B1|Baseline|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160032|NCT01521143|P4|Participant Flow|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
160033|NCT01521143|P3|Participant Flow|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160034|NCT01521143|P2|Participant Flow|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
160035|NCT01521143|P1|Participant Flow|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160036|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
160037|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160038|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
160039|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160040|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
160041|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160042|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
160043|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160044|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
160045|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160046|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
160047|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160048|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
160049|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160050|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
160097|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160098|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160051|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160052|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
160053|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160054|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
160055|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160056|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
160057|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160058|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
160059|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160060|NCT01521143|E4|Reported Event|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
160061|NCT01521143|E3|Reported Event|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160062|NCT01521143|E2|Reported Event|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
160063|NCT01521143|E1|Reported Event|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
160064|NCT01521026|B3|Baseline|Total|Total of all reporting groups
160065|NCT01521026|B2|Baseline|Standard Pharmacotherapy|standard pharmacotherapy with regular clinician
160066|NCT01521026|B1|Baseline|Cognitive Training|Cognitive training group
160067|NCT01521026|P2|Participant Flow|Standard Pharmacotherapy|Standard pharmacotherapy with regular clinician
160068|NCT01521026|P1|Participant Flow|Cognitive Training|Cognitive training group
160069|NCT01521026|O2|Outcome|Standard Pharmacotherapy|Standard pharmacotherapy with the regular clinician
160070|NCT01521026|O1|Outcome|Cognitive Training|Cognitive training group
160071|NCT01521026|O2|Outcome|Standard Pharmacotherapy|Standard pharmacotherapy with the regular clinician
160072|NCT01521026|O1|Outcome|Cognitive Training|Cognitive training group
160073|NCT01521026|E2|Reported Event|Standard Pharmacotherapy|standard pharmacotherapy with regular clinician
160074|NCT01521026|E1|Reported Event|Cognitive Training|Cognitive training group
160075|NCT01520987|B9|Baseline|Total|Total of all reporting groups
160076|NCT01520987|B8|Baseline|Japanese Placebo|"Placebo, PLC
Placebo: once-daily"
160077|NCT01520987|B7|Baseline|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160078|NCT01520987|B6|Baseline|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160079|NCT01520987|B5|Baseline|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160080|NCT01520987|B4|Baseline|Caucasian Placebo|"Placebo, PLC
Placebo: once-daily"
160081|NCT01520987|B3|Baseline|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160082|NCT01520987|B2|Baseline|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160083|NCT01520987|B1|Baseline|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160084|NCT01520987|P8|Participant Flow|Japanese Placebo|"Placebo, PLC
Placebo: once-daily"
160085|NCT01520987|P7|Participant Flow|Japanese 50 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
160086|NCT01520987|P6|Participant Flow|Japanese 25 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
160087|NCT01520987|P5|Participant Flow|Japanese 5 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
160088|NCT01520987|P4|Participant Flow|Caucasian Placebo|"Placebo, PLC
Placebo: once-daily"
160089|NCT01520987|P3|Participant Flow|Caucasian 50 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
160090|NCT01520987|P2|Participant Flow|Caucasian 25 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
160091|NCT01520987|P1|Participant Flow|Caucasian 5 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
160092|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160093|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160094|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160095|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160099|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160100|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160101|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160102|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160103|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160104|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160105|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160106|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160107|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160108|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160109|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160110|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160111|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160112|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160113|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160114|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160115|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160116|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160117|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160118|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160119|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160120|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160121|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160122|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160123|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160124|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160125|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160126|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160127|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160128|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160129|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160130|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160131|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160132|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160133|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160134|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160135|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160136|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160137|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160138|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160139|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160140|NCT01520987|E8|Reported Event|Japanese Placebo|"Placebo, PLC
Placebo: once-daily"
160141|NCT01520987|E7|Reported Event|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160142|NCT01520987|E6|Reported Event|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160143|NCT01520987|E5|Reported Event|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160144|NCT01520987|E4|Reported Event|Caucasian Placebo|"Placebo, PLC
Placebo: once-daily"
160145|NCT01520987|E3|Reported Event|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160146|NCT01520987|E2|Reported Event|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160147|NCT01520987|E1|Reported Event|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
160149|NCT01520922|B2|Baseline|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160150|NCT01520922|B1|Baseline|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160151|NCT01520922|P2|Participant Flow|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160299|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160152|NCT01520922|P1|Participant Flow|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160153|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160154|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160155|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160156|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160157|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160158|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160159|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160160|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160161|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160162|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160163|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160164|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160291|NCT01520727|P5|Participant Flow|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160165|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160166|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160167|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160168|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160169|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160170|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160171|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160172|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160173|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160174|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160175|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160176|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160177|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160178|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160179|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160180|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160292|NCT01520727|P4|Participant Flow|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160181|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160182|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160183|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160184|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160185|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160186|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160187|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160188|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160189|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160190|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160191|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160192|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160193|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160194|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160195|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160196|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160293|NCT01520727|P3|Participant Flow|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160197|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160198|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160199|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160200|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160201|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160202|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160203|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160204|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160205|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160206|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160207|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160208|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160209|NCT01520922|E2|Reported Event|Ofatumumab + Bendamustine 90mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160210|NCT01520922|E1|Reported Event|Ofatumumab + Bendamustine 70mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
160211|NCT01520909|B3|Baseline|Total|Total of all reporting groups
160212|NCT01520909|B2|Baseline|Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight &lt;27 kg received eltrombopag 37.5 mg QD, and those with a body weight &gt;=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines.
160226|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
161675|NCT01516268|B3|Baseline|Total|Total of all reporting groups
160213|NCT01520909|B1|Baseline|Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day. In Part 2, participants received eltrombopag. Participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160267|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160214|NCT01520909|P3|Participant Flow|Part 2 (Open-Label Period) Eltrombopag|All participants receiving placebo in Part 1 received eltrombopag in Part 2 following starting dose guidelines for Part 1. Participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants receiving eltrombopag in Part 1 continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines. Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
160215|NCT01520909|P2|Participant Flow|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines. Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
160216|NCT01520909|P1|Participant Flow|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kilograms (kg) received placebo 37.5 milligrams (mg) once daily (QD), and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 milligrams per kilogram (mg/kg) QD; participants of East Asian ancestry received a starting dose of placebo 0.8 milligrams per kilograms per day (mg/kg/day). Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
160217|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160218|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
160219|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
160220|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160221|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
160222|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
160223|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160224|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
160225|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
162472|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
160227|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
160298|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160778|NCT01519713|E1|Reported Event|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
160228|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
160229|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160230|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
160231|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
160232|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160233|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160234|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight &lt;27 kg received eltrombopag 37.5 mg QD, and those with a body weight &gt;=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160235|NCT01520909|O1|Outcome|Part 1 (Randomized Period) - Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160236|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160237|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160238|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160239|NCT01520909|O1|Outcome|EPart 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160290|NCT01520727|P6|Participant Flow|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
164181|NCT01505374|P1|Participant Flow|Study Technique Right Leg, Control Technique Left Leg|
160266|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160240|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160241|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160242|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160243|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160244|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160245|NCT01520909|O1|Outcome|Part 1(Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160246|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160247|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160248|NCT01520909|O1|Outcome|Part 1 (Randmoized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160249|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160250|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160251|NCT01520909|O1|Outcome|Part 1 (Randmoized Period) -Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160252|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
161676|NCT01516268|B2|Baseline|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
160253|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160254|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160255|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160256|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160257|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160258|NCT01520909|O2|Outcome|Part 1 (Randomized Period) -Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160259|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160260|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160261|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160262|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160263|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160264|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160265|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
161677|NCT01516268|B1|Baseline|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
160268|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160269|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160270|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160271|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160272|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160273|NCT01520909|O1|Outcome|Part 1 (Randomized Period)- Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kilograms (kg) received placebo 37.5 milligrams (mg) once daily (QD), and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 milligrams per kilogram (mg/kg) QD; participants of East Asian ancestry received a starting dose of placebo 0.8 milligrams per kilograms per day (mg/kg/day).
160274|NCT01520909|E3|Reported Event|Part 2: Eltrombopag|In Part 2, participants continued on the same dose of eltrombopag received in Part 1 unless adjustments were warranted according to the dosing guidelines.
160275|NCT01520909|E2|Reported Event|Part 1: Placebo|In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received placebo 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
160276|NCT01520909|E1|Reported Event|Part 1: Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received eltrombopag 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
160277|NCT01520727|B10|Baseline|Total|Total of all reporting groups
160278|NCT01520727|B9|Baseline|Placebo|"Placebo (PLC): single-dose
Placebo: single-dose"
160279|NCT01520727|B8|Baseline|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160280|NCT01520727|B7|Baseline|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160281|NCT01520727|B6|Baseline|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160282|NCT01520727|B5|Baseline|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160283|NCT01520727|B4|Baseline|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160284|NCT01520727|B3|Baseline|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160285|NCT01520727|B2|Baseline|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160286|NCT01520727|B1|Baseline|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160287|NCT01520727|P9|Participant Flow|Placebo|"Placebo (PLC): single-dose
Placebo: single-dose"
160288|NCT01520727|P8|Participant Flow|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160289|NCT01520727|P7|Participant Flow|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160294|NCT01520727|P2|Participant Flow|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160295|NCT01520727|P1|Participant Flow|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160296|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160297|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160779|NCT01519700|B5|Baseline|Total|Total of all reporting groups
160300|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160301|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160302|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160303|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160304|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160305|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160306|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160307|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160308|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160309|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160310|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160311|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160312|NCT01520727|O9|Outcome|Placebo|"Placebo (PLC): single-dose
Placebo: single-dose"
160313|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160314|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160315|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160316|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160317|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160318|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160319|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160320|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160321|NCT01520727|E9|Reported Event|Placebo|"Placebo (PLC): single-dose
Placebo: single-dose"
160322|NCT01520727|E8|Reported Event|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160323|NCT01520727|E7|Reported Event|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160324|NCT01520727|E6|Reported Event|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160325|NCT01520727|E5|Reported Event|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160326|NCT01520727|E4|Reported Event|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160327|NCT01520727|E3|Reported Event|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160328|NCT01520727|E2|Reported Event|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160329|NCT01520727|E1|Reported Event|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
160330|NCT01520714|B3|Baseline|Total|Total of all reporting groups
160347|NCT01520558|O2|Outcome|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160331|NCT01520714|B2|Baseline|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule
Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
160332|NCT01520714|B1|Baseline|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule
Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
160333|NCT01520714|P2|Participant Flow|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV Lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule
Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
160334|NCT01520714|P1|Participant Flow|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule
Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
160335|NCT01520714|O2|Outcome|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms both had same follow-up testing and schedule.
Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead: 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images were taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
160336|NCT01520714|O1|Outcome|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms both had same follow-up testing and schedule.
Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead: 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images were taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
160337|NCT01520714|E2|Reported Event|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule
Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
160338|NCT01520714|E1|Reported Event|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule
Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
160339|NCT01520558|B4|Baseline|Total|Total of all reporting groups
160340|NCT01520558|B3|Baseline|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160341|NCT01520558|B2|Baseline|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160342|NCT01520558|B1|Baseline|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160343|NCT01520558|P3|Participant Flow|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160344|NCT01520558|P2|Participant Flow|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160345|NCT01520558|P1|Participant Flow|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160346|NCT01520558|O3|Outcome|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160348|NCT01520558|O1|Outcome|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160349|NCT01520558|E3|Reported Event|CNDO-109-AANK Cells Dose 3|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160350|NCT01520558|E2|Reported Event|CNDO-109-AANK Cells Dose 2|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160351|NCT01520558|E1|Reported Event|CNDO-109-AANK Cells Dose 1|"In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion"
160352|NCT01520532|B1|Baseline|Ablation|
160353|NCT01520532|P1|Participant Flow|Ablation|Single-arm study, all subjects received a radio-frequency (RF) ablation with the goal of achieving Pulmonary Vein Isolation (PVI).
160354|NCT01520532|O1|Outcome|Ablation|
160355|NCT01520532|O1|Outcome|Ablation|
160356|NCT01520532|O1|Outcome|Ablation|
160357|NCT01520532|E1|Reported Event|Ablation|
160358|NCT01520506|B1|Baseline|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
160359|NCT01520506|P1|Participant Flow|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. Radiofrequency (RF) is applied with pre-programmed time and intensity in each of the renal arteries.
160360|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
160361|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
160362|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
160363|NCT01520506|E1|Reported Event|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
160364|NCT01520454|B5|Baseline|Total|Total of all reporting groups
160365|NCT01520454|B4|Baseline|Oral Fat|"Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
160366|NCT01520454|B3|Baseline|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160367|NCT01520454|B2|Baseline|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160368|NCT01520454|B1|Baseline|Placebo|"IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160369|NCT01520454|P4|Participant Flow|Oral Fat|"Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
160370|NCT01520454|P3|Participant Flow|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160371|NCT01520454|P2|Participant Flow|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160372|NCT01520454|P1|Participant Flow|Placebo|"IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours"
160373|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
160374|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160375|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160614|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160376|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160377|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
160378|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160379|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160380|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160381|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
160382|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160383|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160384|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160385|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
160386|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160387|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160388|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160389|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
160390|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160391|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160392|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160393|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
160394|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160395|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160396|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160397|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
160398|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160399|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160400|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160401|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
160402|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
161678|NCT01516268|P2|Participant Flow|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
160403|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160404|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160405|NCT01520454|E4|Reported Event|Oral Fat|"Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
160406|NCT01520454|E3|Reported Event|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160407|NCT01520454|E2|Reported Event|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160408|NCT01520454|E1|Reported Event|Placebo|"IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
160409|NCT01520402|B1|Baseline|Warfarin|"Healthy subjects age 18-74 with no medical indication for warfarin therapy, who are free of medications and co-morbid medical conditions with the potential to interfere with warfarin metabolism, and who are willing to follow a fixed vitamin K diet (men 120 micrograms/day, women 90 micrograms/day) are included.
Warfarin : Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin)."
160410|NCT01520402|P1|Participant Flow|Warfarin|"Healthy subjects age 18-74 with no medical indication for warfarin therapy, who are free of medications and co-morbid medical conditions with the potential to interfere with warfarin metabolism, and who are willing to follow a fixed vitamin K diet (men 120 micrograms/day, women 90 micrograms/day) are included.
Warfarin : Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin)."
160411|NCT01520402|O1|Outcome|CYP2C9/VKORC1 Genotype Group|Group 1 (CYP2C9 wild-type and VKORC1 wild-type), Group 2 (CYP2C9 wild-type and VKORC1 variant), Group 3 (CYP2C9 variant and VKORC1 wild-type), and Group 4 (CYP2C9 variant and VKORC1 variant).
160412|NCT01520402|O4|Outcome|Demographic Plus CYP2C9 and VKORC1 and CYP4F2|
160413|NCT01520402|O3|Outcome|Demographic Plus CYP2C9 and VKORC1|
160414|NCT01520402|O2|Outcome|Demographic Plus CYP2C9|
160415|NCT01520402|O1|Outcome|Demographic Only|Demographic variables were gender, age, and race.
160416|NCT01520402|O1|Outcome|CYP4F2 (p.V433M; c.1297G>A)|"CYP4F2 G/G was defined as wild-type, CYP4F2 G/A was defined as single-variant, and CYP4F2 A/A was defined as double-variant"
160417|NCT01520402|O2|Outcome|VKORC1 -1639 G>A|"VKORC1 GG was defined as wild-type; VKORC1 G/A was defined as single variant; and VKORC1 A/A was defined as double variant."
160418|NCT01520402|O1|Outcome|CYP2C9|"The wild-type CYP2C9 allele (*1) was assigned in the absence of other detectable variant alleles. Extensive metabolizers (EMs) were defined as *1/*1 wild-type, intermediate metabolizers (IMs) as *1/variant single variant; and poor metabolizers (PMs) as variant/variant double variant."
160419|NCT01520402|E1|Reported Event|Warfarin|Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin).
160420|NCT01519960|B4|Baseline|Total|Total of all reporting groups
160421|NCT01519960|B3|Baseline|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160422|NCT01519960|B2|Baseline|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160423|NCT01519960|B1|Baseline|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160564|NCT01519882|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160424|NCT01519960|P3|Participant Flow|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160460|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
162481|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
160425|NCT01519960|P2|Participant Flow|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160426|NCT01519960|P1|Participant Flow|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received peginterferon alfa-2a (PEG-IFN) monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on body surface area (BSA) and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 square meters (m^2), 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; greater than (>) 1.51 m^2, 180 mcg.
160427|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160428|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160429|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160430|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160431|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160432|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160433|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160434|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160435|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160608|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
164182|NCT01505374|O1|Outcome|All Patients|
160461|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160436|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160437|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160438|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160439|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160440|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160441|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160442|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160443|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160444|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160445|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160446|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160459|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
161679|NCT01516268|P1|Participant Flow|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
160447|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160448|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160449|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160450|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160451|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160452|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160453|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160454|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160455|NCT01519960|O1|Outcome|All Groups Combined|Participants without advanced fibrosis were randomized to receive PEG-IFN monotherapy or were evaluated as untreated control for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for the same duration. For those who received PEG-IFN treatment, each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160456|NCT01519960|O3|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160457|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160458|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160462|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160463|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160464|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160465|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160466|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160467|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160468|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160469|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160470|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160471|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160472|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160473|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160561|NCT01519921|E2|Reported Event|PEG-IFN Alfa-2a (YMDD Mutant)|Group B included tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants who received PEGASYS 180mcg subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up.
160474|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160475|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160476|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160477|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160478|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160479|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160480|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160481|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160482|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160483|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160484|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160485|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160562|NCT01519921|E1|Reported Event|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
160563|NCT01519882|B3|Baseline|Total|Total of all reporting groups
164183|NCT01505374|O1|Outcome|All Patients|
164184|NCT01505374|O1|Outcome|All Patients|
160486|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160508|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160487|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160488|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160489|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160490|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160491|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160492|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160493|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160494|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160495|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160496|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160609|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160772|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
160565|NCT01519882|B1|Baseline|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160497|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160498|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160499|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160500|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160501|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160502|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160503|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160504|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160505|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160506|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160507|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160509|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160510|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160511|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160512|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160513|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160514|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160515|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160516|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160517|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160518|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160610|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160773|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
160566|NCT01519882|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160519|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160520|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160521|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160522|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160523|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160524|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160525|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
160526|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160527|NCT01519960|E4|Reported Event|Group D: Switch to PEG-IFN Monotherapy|Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy. Treatment was given over 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. Because participants could switch from Group B to Group D for up to 1 year following the Week 48 visit, not all participants had reached FU Week 24 at time of analysis.
160528|NCT01519960|E3|Reported Event|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160529|NCT01519960|E2|Reported Event|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up.
160611|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160612|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160530|NCT01519960|E1|Reported Event|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
160531|NCT01519934|B1|Baseline|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
160532|NCT01519934|P1|Participant Flow|Ulthera-treated Subjects|All enrolled subjects had received one Ulthera treatment on the face and neck at two treatment depths, 4.5mm and 3.0mm depths, prior to enrollment.
160533|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
160534|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
160535|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
160536|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
160537|NCT01519934|E1|Reported Event|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
160538|NCT01519921|B3|Baseline|Total|Total of all reporting groups
160539|NCT01519921|B2|Baseline|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
160540|NCT01519921|B1|Baseline|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
160541|NCT01519921|P2|Participant Flow|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
160542|NCT01519921|P1|Participant Flow|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
160543|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
160544|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
160545|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
160546|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
160547|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
160548|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
160549|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
160550|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
160551|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
160552|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
160553|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
160554|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
160555|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
160556|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
160557|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
160558|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
160559|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
160560|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
191339|NCT01405794|O2|Outcome|32ppm Oral Silver|
160567|NCT01519882|P1|Participant Flow|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160568|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160569|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160570|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160571|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160572|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160573|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160574|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160575|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160576|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160577|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160578|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160579|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160580|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160581|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160613|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
191340|NCT01405794|O1|Outcome|Placebo|
160582|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160583|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160584|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160585|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160586|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160587|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160588|NCT01519882|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patches
Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
160589|NCT01519882|E1|Reported Event|Placebo|"Placebo Transdermal Patches
Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
160590|NCT01519817|B1|Baseline|All Participants|"All participants who received at least one dose of 4YU, 16YU, 40YU or 80YU.
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
GI-6301 (Yeast Brachyury Vaccine): GI-6301 is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product."
160591|NCT01519817|P4|Participant Flow|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160592|NCT01519817|P3|Participant Flow|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160593|NCT01519817|P2|Participant Flow|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160594|NCT01519817|P1|Participant Flow|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160595|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160596|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160597|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160598|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160599|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160600|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160601|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160602|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160603|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160604|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160605|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160606|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160607|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160615|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160616|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160617|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160618|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160619|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160620|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160621|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160622|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160623|NCT01519817|O4|Outcome|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160624|NCT01519817|O3|Outcome|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160625|NCT01519817|O2|Outcome|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160626|NCT01519817|O1|Outcome|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160627|NCT01519817|E4|Reported Event|80 YU (Dose Level 4)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160628|NCT01519817|E3|Reported Event|40 YU (Dose Level 3)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160629|NCT01519817|E2|Reported Event|16 YU (Dose Level 2)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160630|NCT01519817|E1|Reported Event|4 YU (Dose Level 1)|Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
160631|NCT01519791|B3|Baseline|Total Title|
160632|NCT01519791|B2|Baseline|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160633|NCT01519791|B1|Baseline|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160634|NCT01519791|P2|Participant Flow|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160635|NCT01519791|P1|Participant Flow|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160636|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160637|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160638|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160639|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
165091|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (TOC)|TOC - 28 to 35 days after start of study drug
160640|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160776|NCT01519713|E3|Reported Event|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
160641|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160642|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160643|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160644|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160645|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160646|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160647|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160648|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160649|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160650|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160651|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160652|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160653|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160729|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
165092|NCT01499290|O2|Outcome|Meropenem (EOT)|EOT - within 24 hours after last dose of study drug
160654|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160655|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160656|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160657|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160658|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160659|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160660|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160661|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160662|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160663|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160664|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160665|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160666|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160667|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160730|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
165096|NCT01499290|O4|Outcome|Meropenem (TOC)|TOC - 28 to 35 days after start of study drug
160668|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160669|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160670|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160671|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160672|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160673|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160674|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160675|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160676|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160677|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160678|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160679|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160680|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160681|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160731|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
165097|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (TOC)|TOC - 28 to 35 days after start of study drug
160682|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160683|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160684|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160685|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160686|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160687|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160688|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160689|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160690|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160691|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160692|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160693|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160694|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160695|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160732|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
165098|NCT01499290|O2|Outcome|Meropenem (EOT)|EOT - within 24 hours of last dose of study drug
160696|NCT01519791|E2|Reported Event|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160697|NCT01519791|E1|Reported Event|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.
The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
160698|NCT01519778|B1|Baseline|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
160699|NCT01519778|P1|Participant Flow|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
160700|NCT01519778|O1|Outcome|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
160701|NCT01519778|E1|Reported Event|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
160702|NCT01519765|B3|Baseline|Total|Total of all reporting groups
160703|NCT01519765|B2|Baseline|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160704|NCT01519765|B1|Baseline|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160705|NCT01519765|P2|Participant Flow|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160706|NCT01519765|P1|Participant Flow|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160707|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160708|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160709|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160710|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160711|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160712|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160713|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160714|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160715|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160716|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160717|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160718|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160719|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160720|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160721|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160722|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160723|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160724|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160725|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160726|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160727|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160728|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160733|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160734|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160777|NCT01519713|E2|Reported Event|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
160735|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160736|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160737|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160738|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160739|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160740|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
This same regimen was then repeated every four hours according to protocol."
160741|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160742|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160743|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160744|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160745|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160746|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
This same regimen was then repeated every four hours according to protocol."
160747|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160748|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
This same regimen was then repeated every four hours according to protocol."
160749|NCT01519765|E2|Reported Event|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
160750|NCT01519765|E1|Reported Event|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.
The same regimen was then repeated every four hours according to protocol."
160751|NCT01519713|B4|Baseline|Total|Total of all reporting groups
160752|NCT01519713|B3|Baseline|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
160753|NCT01519713|B2|Baseline|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
160754|NCT01519713|B1|Baseline|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
160755|NCT01519713|P3|Participant Flow|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
160756|NCT01519713|P2|Participant Flow|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
160757|NCT01519713|P1|Participant Flow|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
160758|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
160759|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
160760|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
160761|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
160762|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
160763|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
160764|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
160765|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
160766|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
160767|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
160768|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
160769|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
160770|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
160771|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
165398|NCT01498458|B1|Baseline|Pazopanib Plus Capecitabine|pazopanib plus capecitabine
160774|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
160775|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
160780|NCT01519700|B4|Baseline|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
160781|NCT01519700|B3|Baseline|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
160782|NCT01519700|B2|Baseline|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
160783|NCT01519700|B1|Baseline|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
160784|NCT01519700|P4|Participant Flow|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study, daily dose of 5 mcg/kg body weight, subcutaneously
160785|NCT01519700|P3|Participant Flow|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle, daily dose of 5 mcg/kg body weight, subcutaneously
160786|NCT01519700|P2|Participant Flow|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle, daily dose of 5 mcg/kg body weight, subcutaneously
160787|NCT01519700|P1|Participant Flow|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study daily dose of 5 mcg/kg body weight, subcutaneously
160788|NCT01519700|O5|Outcome|Total|All patients
160789|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
160790|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
160791|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
160792|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
160793|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
160794|NCT01519700|O2|Outcome|EP2006 & Neupogen + Neupogen & EP2006|All subjects randomized to receive EP2006 & Neupogen + Neupogen & EP2006.
160795|NCT01519700|O1|Outcome|EP2006 + Neupogen|All subjects randomized to receive either EP2006 or Neupogen.
160796|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
160797|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
160798|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
160799|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
160800|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
160801|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
160802|NCT01519700|O5|Outcome|Total|All patients
160803|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
160804|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
160805|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
160806|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
160807|NCT01519700|O5|Outcome|Total|All patients
160808|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
160809|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
160810|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
160811|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
160812|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
160813|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
160814|NCT01519700|E4|Reported Event|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
160815|NCT01519700|E3|Reported Event|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
160816|NCT01519700|E2|Reported Event|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
160817|NCT01519700|E1|Reported Event|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
160818|NCT01519674|B4|Baseline|Total|Total of all reporting groups
160819|NCT01519674|B3|Baseline|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160820|NCT01519674|B2|Baseline|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160903|NCT01519466|P2|Participant Flow|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
165470|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
160821|NCT01519674|B1|Baseline|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160822|NCT01519674|P3|Participant Flow|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
161692|NCT01516008|P3|Participant Flow|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
160823|NCT01519674|P2|Participant Flow|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160824|NCT01519674|P1|Participant Flow|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160825|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160826|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160827|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160828|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160829|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160830|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160831|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160832|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160833|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160834|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160835|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160836|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160837|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160838|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160839|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160840|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160841|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160842|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160843|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160844|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160845|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160846|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160847|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160848|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160849|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160850|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160851|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160852|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160853|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160854|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160855|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160856|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160857|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160858|NCT01519674|E3|Reported Event|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160859|NCT01519674|E2|Reported Event|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
160860|NCT01519674|E1|Reported Event|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
160861|NCT01519661|B1|Baseline|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160862|NCT01519661|P1|Participant Flow|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160863|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160864|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160865|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160866|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160867|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160868|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160869|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. Total number of isolates at each cycle/day: baseline = 279; cycle 1, day 29 = 252; cycle 2, day 85 = 238; cycle 3, day 141 = 210; cycle 4, day 197 = 184; cycle 5, day 253 = 178; cycle 6, day 309 = 164; and completion, day 337 = 158
160904|NCT01519466|P1|Participant Flow|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
160870|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160907|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
160966|NCT01519284|E2|Reported Event|Group 2|"Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160871|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160872|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160873|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160874|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160875|NCT01519661|E1|Reported Event|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
160876|NCT01519648|B3|Baseline|Total|Total of all reporting groups
160877|NCT01519648|B2|Baseline|Allo- or Auto- Transplant Recipients|
160878|NCT01519648|B1|Baseline|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
160879|NCT01519648|P2|Participant Flow|Allo- or Auto- Transplant Recipients|
160880|NCT01519648|P1|Participant Flow|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
160881|NCT01519648|O2|Outcome|Allo- or Auto- Transplant Recipients|Allo- or auto- transplant recipients
160882|NCT01519648|O1|Outcome|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
160883|NCT01519648|E2|Reported Event|Allo- or Auto- Transplant Recipients|
160884|NCT01519648|E1|Reported Event|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
160885|NCT01519518|B3|Baseline|Total|Total of all reporting groups
160886|NCT01519518|B2|Baseline|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
160887|NCT01519518|B1|Baseline|Unfractionated Heparin|"70 units/kg body weight intravenous
unfractionated heparin: 70 units/kg body weight intravenous"
160888|NCT01519518|P2|Participant Flow|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
160889|NCT01519518|P1|Participant Flow|Unfractionated Heparin|"70 units/kg body weight intravenous
unfractionated heparin: 70 units/kg body weight intravenous"
160890|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
160891|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous
unfractionated heparin: 70 units/kg body weight intravenous"
160892|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
160893|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous
unfractionated heparin: 70 units/kg body weight intravenous"
160894|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
160895|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous
unfractionated heparin: 70 units/kg body weight intravenous"
160896|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
160897|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous
unfractionated heparin: 70 units/kg body weight intravenous"
160898|NCT01519518|E2|Reported Event|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
160899|NCT01519518|E1|Reported Event|Unfractionated Heparin|"70 units/kg body weight intravenous
unfractionated heparin: 70 units/kg body weight intravenous"
160900|NCT01519466|B3|Baseline|Total|Total of all reporting groups
160901|NCT01519466|B2|Baseline|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
160902|NCT01519466|B1|Baseline|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
161680|NCT01516268|O2|Outcome|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
160905|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
160906|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
160908|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
160909|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
160910|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
160911|NCT01519466|E2|Reported Event|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
160912|NCT01519466|E1|Reported Event|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
160913|NCT01519427|B1|Baseline|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
160914|NCT01519427|P1|Participant Flow|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
160915|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
160916|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
160917|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
160918|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
160919|NCT01519427|E1|Reported Event|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
160920|NCT01519323|B1|Baseline|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
160921|NCT01519323|P2|Participant Flow|Vemurafenib Dose Escalation Cohort Level 2|Participants received 960 mg of vemurafenib by mouth BID.
160922|NCT01519323|P1|Participant Flow|Vemurafenib Dose Escalation Cohort Level 1|Participants received 720 milligram (mg) of vemurafenib by mouth twice daily (BID).
160923|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
160924|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
160925|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
160926|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
160927|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
160928|NCT01519323|O2|Outcome|Vemurafenib 960 mg|Participants enrolled in the second cohort received vemurafenib 960 mg by mouth BID.
160929|NCT01519323|O1|Outcome|Vemurafenib 720 mg|Participants enrolled in the first cohort received vemurafenib 720 mg by mouth BID.
160963|NCT01519284|E5|Reported Event|Group 5|"Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
161681|NCT01516268|O1|Outcome|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
160930|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
160967|NCT01519284|E1|Reported Event|Group 1|Placebo at all the dosing times
160931|NCT01519323|E1|Reported Event|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
160932|NCT01519284|B6|Baseline|Total|Total of all reporting groups
160933|NCT01519284|B5|Baseline|Group 5|"Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
Entacapone: Entacapone 200 mg
Placebo: placebo (four times a day)
levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)"
160934|NCT01519284|B4|Baseline|Group 4|"Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose
Placebo: placebo (four times a day)
levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)
BIA 9-1067 30 mg: BIA 9-1067 OPC, Opicapone 30 mg"
160935|NCT01519284|B3|Baseline|Group 3|"Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
Placebo: placebo (four times a day)
levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)
BIA 9-1067 15 mg: BIA 9-1067 OPC, Opicapone 15 mg"
160936|NCT01519284|B2|Baseline|Group 2|"Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
BIA 9-1067 5 mg: BIA 9-1067 OPC, Opicapone 5 mg
Placebo: placebo (four times a day)
levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)"
160937|NCT01519284|B1|Baseline|Group 1|"Placebo at all the dosing times
Placebo: placebo (four times a day)"
160938|NCT01519284|P5|Participant Flow|Group 5|"Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
160939|NCT01519284|P4|Participant Flow|Group 4|"Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
160940|NCT01519284|P3|Participant Flow|Group 3|"Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160941|NCT01519284|P2|Participant Flow|Group 2|"Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160942|NCT01519284|P1|Participant Flow|Group 1|Placebo at all the dosing times
160943|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
160944|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
160945|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160946|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160947|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
160948|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
160949|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
160950|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160951|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160952|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
160953|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
160954|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
160955|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160956|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160957|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
160958|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
160959|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
160960|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160961|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160962|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
160964|NCT01519284|E4|Reported Event|Group 4|"Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
160965|NCT01519284|E3|Reported Event|Group 3|"Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
160968|NCT01519271|B3|Baseline|Total|Total of all reporting groups
160969|NCT01519271|B2|Baseline|5-10cm2 Rivastigmine Patch First First Then Placebo Patch|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.
5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )
Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
Each phase lasted 10 weeks."
160970|NCT01519271|B1|Baseline|Placebo Patch First Then 5-10cm2 Rivastigmine Patch|"Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.
5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )
Each phase lasted 10 weeks."
160971|NCT01519271|P2|Participant Flow|Rivastigmine First Then Placebo|"5-10cm2 rivastigmine patch daily first in phase 1 and placebo patch daily in phase 2. Each phase lasted for 10 weeks.
Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.
5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )
Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)."
160972|NCT01519271|P1|Participant Flow|Placebo First Then Rivastigmine|"Placebo patches placed on skin daily in Phase 1 and Rivastigmine 5-10cm2 patches in Phase 2. Each phase lasted for 10 weeks.
Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.
5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )
Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)."
160973|NCT01519271|O2|Outcome|Rivastigmine|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.
5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
160974|NCT01519271|O1|Outcome|Placebo|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
160975|NCT01519271|O2|Outcome|Exelon Patch (Rivastigmine Transdermal System)|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.
5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
160976|NCT01519271|O1|Outcome|Placebo Patch|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
160977|NCT01519271|E2|Reported Event|Exelon Patch (Rivastigmine Transdermal System)|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.
5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
160978|NCT01519271|E1|Reported Event|Placebo Patch|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
160979|NCT01519245|B3|Baseline|Total|Total of all reporting groups
160980|NCT01519245|B2|Baseline|Placebo|Normal saline (70mL)
160981|NCT01519245|B1|Baseline|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
160982|NCT01519245|P2|Participant Flow|Placebo|Normal saline (70mL)
160983|NCT01519245|P1|Participant Flow|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
160984|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
160985|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
160986|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
160987|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
160988|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
160989|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
160990|NCT01519245|O2|Outcome|Placebo|"Normal saline (70mL)
Total duration that chest tubes were in-situ before removal = 21 hours (SD 2)"
160991|NCT01519245|O1|Outcome|Trial Drug|"Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
Total duration that chest tubes were in-situ before removal = 20 hours (SD 3)"
160992|NCT01519245|E2|Reported Event|Placebo|Normal saline (70mL)
160993|NCT01519245|E1|Reported Event|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
160994|NCT01519206|B1|Baseline|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
160995|NCT01519206|P1|Participant Flow|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
160996|NCT01519206|O3|Outcome|Treated Subjects PSQ Data - 1 Year Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
160997|NCT01519206|O2|Outcome|Treated Subjects PSQ Data - 180 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
161086|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
160998|NCT01519206|O1|Outcome|Treated Subjects PSQ Data - 90 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
160999|NCT01519206|O1|Outcome|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
161000|NCT01519206|O4|Outcome|Treated Subjects GAIS Data - 1 Year Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
161047|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161001|NCT01519206|O3|Outcome|Treated Subjects GAIS Data - 180 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
161002|NCT01519206|O2|Outcome|Treated Subjects GAIS Data - 90 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
161003|NCT01519206|O1|Outcome|Treated Subjects GAIS Data - 60 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
161004|NCT01519206|O1|Outcome|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
161005|NCT01519206|E1|Reported Event|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
161006|NCT01519167|B3|Baseline|Total|Total of all reporting groups
161007|NCT01519167|B2|Baseline|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161008|NCT01519167|B1|Baseline|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161009|NCT01519167|P2|Participant Flow|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161010|NCT01519167|P1|Participant Flow|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161011|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161012|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161013|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161014|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161015|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161016|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161017|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161018|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161019|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161020|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161021|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161022|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161023|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161024|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161025|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161026|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161027|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161028|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161029|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161030|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161031|NCT01519167|E2|Reported Event|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
161032|NCT01519167|E1|Reported Event|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
161033|NCT01519089|B3|Baseline|Total|Total of all reporting groups
161034|NCT01519089|B2|Baseline|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161035|NCT01519089|B1|Baseline|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161036|NCT01519089|P2|Participant Flow|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161037|NCT01519089|P1|Participant Flow|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161038|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161039|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161040|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161041|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161042|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161682|NCT01516268|E2|Reported Event|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
161043|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161044|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161045|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161046|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161048|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161049|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161050|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161051|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161052|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161053|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161054|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161055|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161056|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161057|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161058|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161059|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161060|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161061|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161062|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161063|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161064|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161065|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161066|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161067|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161068|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161069|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161070|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161071|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161072|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161073|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161074|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161075|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161076|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161077|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161078|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161079|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161080|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161081|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161082|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161083|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161084|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161085|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161087|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161088|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161089|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161090|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161134|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161091|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161092|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161093|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161094|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161095|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161096|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161097|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161098|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161099|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161100|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161101|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161102|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161103|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161104|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161105|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161106|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161107|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161108|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161109|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161110|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161111|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161112|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161113|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161114|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161115|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161116|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161117|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161118|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161119|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161120|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161121|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161122|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161123|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161124|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161125|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161126|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161127|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161128|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161129|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161130|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161131|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161132|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161133|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161135|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161136|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161137|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161138|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161139|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161140|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161141|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161142|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161143|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161144|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161145|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161146|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161147|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161148|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161149|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
161150|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161151|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161152|NCT01519089|E3|Reported Event|Total|(=sum across Arm/Groups)
161153|NCT01519089|E2|Reported Event|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161154|NCT01519089|E1|Reported Event|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
161155|NCT01518946|B3|Baseline|Total|Total of all reporting groups
161156|NCT01518946|B2|Baseline|Midodrine HCl First, Then Placebo (Randomized Phase)|Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
161157|NCT01518946|B1|Baseline|Placebo First, Then Midodrine HCl (Randomized Phase)|Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
161158|NCT01518946|P3|Participant Flow|Midodrine HCl First, Then Placebo (Randomized Phase)|Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
161159|NCT01518946|P2|Participant Flow|Placebo First, Then Midodrine HCl (Randomized Phase)|Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
161160|NCT01518946|P1|Participant Flow|Midodrine HCl (Open-label Phase)|On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld.
161161|NCT01518946|O2|Outcome|Midodrine HCl|dose at the subject's current dose level
161162|NCT01518946|O1|Outcome|Placebo|single dose of matching placebo
161163|NCT01518946|E3|Reported Event|Midodrine HCl (Randomized Phase)|dose at the subject's current dose level
161164|NCT01518946|E2|Reported Event|Placebo (Randomized Phase)|single dose of matching placebo
161165|NCT01518946|E1|Reported Event|Midodrine HCl (Open-label Phase)|dose at the subject's current dose level
161166|NCT01518530|B1|Baseline|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
161167|NCT01518530|P1|Participant Flow|Chronic Neck Pain Patients Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
161168|NCT01518530|O1|Outcome|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
161169|NCT01518530|E1|Reported Event|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
161170|NCT01518322|B1|Baseline|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
161171|NCT01518322|P1|Participant Flow|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
161172|NCT01518322|O1|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
161208|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161694|NCT01516008|P1|Participant Flow|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161173|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
161174|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
161175|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
161176|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high
161177|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
161178|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
161179|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
161180|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
161181|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
161182|NCT01518322|E1|Reported Event|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
161183|NCT01518270|B1|Baseline|Healthy Females|Participant's eyelashes were photographed at one study visit.
161184|NCT01518270|P1|Participant Flow|Healthy Females|Participant's eyelashes were photographed at one study visit.
161185|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
161186|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
161187|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
161188|NCT01518270|E1|Reported Event|Healthy Females|Healthy Females
161189|NCT01518257|B3|Baseline|Total|Total of all reporting groups
161190|NCT01518257|B2|Baseline|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161191|NCT01518257|B1|Baseline|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161192|NCT01518257|P2|Participant Flow|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161193|NCT01518257|P1|Participant Flow|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161194|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161195|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161196|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161197|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161198|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161199|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161200|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161201|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161202|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161203|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161204|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161205|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161206|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161207|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161209|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161210|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161211|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161212|NCT01518257|E2|Reported Event|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
161213|NCT01518257|E1|Reported Event|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
161214|NCT01518244|B1|Baseline|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
161215|NCT01518244|P1|Participant Flow|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
161216|NCT01518244|O1|Outcome|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
161217|NCT01518244|O1|Outcome|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
161218|NCT01518244|E1|Reported Event|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
161219|NCT01518192|B4|Baseline|Total|Total of all reporting groups
161220|NCT01518192|B3|Baseline|Controls|To obtain a control group from the same geographical area, each patient was asked if he/she had a family member or friend who was within 5 years of his/her age and had no history of Lyme disease (two of the potential control subjects were excluded due to this reason), and was not pregnant, lactating or immunocompromised.
161221|NCT01518192|B2|Baseline|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.
Evaluations:
At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture."
161222|NCT01518192|B1|Baseline|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.
Evaluations:
At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture."
161223|NCT01518192|P3|Participant Flow|Controls|patients' family members or friends without a history of Lyme disease
161224|NCT01518192|P2|Participant Flow|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.
At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
161225|NCT01518192|P1|Participant Flow|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.
At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
161226|NCT01518192|O2|Outcome|Controls|controls with selected subjective symptoms at 12 months post inclusion
161227|NCT01518192|O1|Outcome|Patients|patients with selected subjective symptoms at 12 months post inclusion
161228|NCT01518192|O2|Outcome|Controls|controls with new or increased symptoms since erythema migrans at 12 months post inclusion
161229|NCT01518192|O1|Outcome|Patients|patients with new or increased symptoms since erythema migrans at 12 months post inclusion
161230|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
161231|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
161232|NCT01518192|O2|Outcome|Cefuroximew Axetil|cefuroxime axetil 500 mg twice daily for 15 days
161233|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
161234|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
161235|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
161236|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
161237|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
161238|NCT01518192|O2|Outcome|Controls|controls with new or increased symptoms since enrollment at 6 months post inclusion
161239|NCT01518192|O1|Outcome|Patients|patients with new or increased symptoms since erythema migrans at 6 months post inclusion
161240|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
161241|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
161242|NCT01518192|E3|Reported Event|Controls|patients' family members or friends without a history of Lyme disease
161243|NCT01518192|E2|Reported Event|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.
At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
161319|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161244|NCT01518192|E1|Reported Event|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.
At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
161325|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
163094|NCT01510158|B2|Baseline|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
161245|NCT01518153|B1|Baseline|Stem Cell Transplant + Donor Lymphocyte Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
161246|NCT01518153|P3|Participant Flow|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
161247|NCT01518153|P2|Participant Flow|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
161248|NCT01518153|P1|Participant Flow|Stem Cell Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.
161249|NCT01518153|O1|Outcome|Stem Cell Transplant + Donor Lymphocyte Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
161250|NCT01518153|O2|Outcome|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
161251|NCT01518153|O1|Outcome|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
161252|NCT01518153|E3|Reported Event|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
161253|NCT01518153|E2|Reported Event|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
161254|NCT01518153|E1|Reported Event|Stem Cell Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.
161255|NCT01517984|B4|Baseline|Total|Total of all reporting groups
161320|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161683|NCT01516268|E1|Reported Event|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
161326|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
161693|NCT01516008|P2|Participant Flow|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161256|NCT01517984|B3|Baseline|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161257|NCT01517984|B2|Baseline|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161258|NCT01517984|B1|Baseline|Transplanted, But Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
161259|NCT01517984|P4|Participant Flow|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161260|NCT01517984|P3|Participant Flow|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161261|NCT01517984|P2|Participant Flow|Transplanted, Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
161262|NCT01517984|P1|Participant Flow|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did receive a living-donor kidney allograft transplant as specified by the protocol.
161263|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161264|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161265|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161321|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
161322|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
161266|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161267|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161268|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161269|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161270|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161271|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161272|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161273|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161274|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161323|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161684|NCT01516034|B1|Baseline|Treatment|Cupola tattoo removal treatment
161275|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161276|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161277|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161278|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161279|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161280|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161281|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161282|NCT01517984|E3|Reported Event|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
161283|NCT01517984|E2|Reported Event|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
161324|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161685|NCT01516034|P1|Participant Flow|Treatment|Cupola tattoo removal treatment
161284|NCT01517984|E1|Reported Event|Transplanted, But Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
161285|NCT01517893|B3|Baseline|Total|Total of all reporting groups
161286|NCT01517893|B2|Baseline|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
161287|NCT01517893|B1|Baseline|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated
Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
161288|NCT01517893|P2|Participant Flow|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
161289|NCT01517893|P1|Participant Flow|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated
Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
161290|NCT01517893|O2|Outcome|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
161291|NCT01517893|O1|Outcome|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated
Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
161292|NCT01517893|E2|Reported Event|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
161293|NCT01517893|E1|Reported Event|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated
Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
161294|NCT01517750|B5|Baseline|Total|Total of all reporting groups
161295|NCT01517750|B4|Baseline|APAP Without Humidification + High Risks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161296|NCT01517750|B3|Baseline|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161297|NCT01517750|B2|Baseline|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
161298|NCT01517750|B1|Baseline|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
161299|NCT01517750|P4|Participant Flow|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
161300|NCT01517750|P3|Participant Flow|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
161301|NCT01517750|P2|Participant Flow|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
161302|NCT01517750|P1|Participant Flow|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
161303|NCT01517750|O4|Outcome|WIthout Previous ENT Surgeries + WIthout Humidification|
161304|NCT01517750|O3|Outcome|Without Previous ENT Surgeries + Humidification|
161305|NCT01517750|O2|Outcome|Previous ENT Surgeries + Without Humidification|
161306|NCT01517750|O1|Outcome|Previous ENT Surgeries + Humidification|
161307|NCT01517750|O4|Outcome|WIthout Previous ENT Surgeries + WIthout Humidification|
161308|NCT01517750|O3|Outcome|Without Previous ENT Surgeries + Humidification|
161309|NCT01517750|O2|Outcome|Previous ENT Surgeries + Without Humidification|
161310|NCT01517750|O1|Outcome|Previous ENT Surgeries + Humidification|
161311|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161312|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161313|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
161314|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
161315|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161316|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161317|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
161318|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
161327|NCT01517750|E4|Reported Event|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161328|NCT01517750|E3|Reported Event|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
161329|NCT01517750|E2|Reported Event|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
161330|NCT01517750|E1|Reported Event|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
161331|NCT01517529|B1|Baseline|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
161332|NCT01517529|P1|Participant Flow|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who failed the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
161333|NCT01517529|O1|Outcome|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
161334|NCT01517529|O1|Outcome|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
161335|NCT01517529|E1|Reported Event|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
161336|NCT01517412|B3|Baseline|Total|Total of all reporting groups
161337|NCT01517412|B2|Baseline|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161338|NCT01517412|B1|Baseline|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161339|NCT01517412|P2|Participant Flow|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161340|NCT01517412|P1|Participant Flow|Lixisenatide Main Meal|Lixisenatide 10 mcg subcutaneous (SC) injection once daily (QD) within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161341|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161342|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161343|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161344|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161345|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161346|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161347|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161348|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161349|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161350|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161351|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161352|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161353|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161354|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161355|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161356|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161357|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161358|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161359|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161360|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161361|NCT01517412|E2|Reported Event|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161362|NCT01517412|E1|Reported Event|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
161363|NCT01517373|B6|Baseline|Total|Total of all reporting groups
161364|NCT01517373|B5|Baseline|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161365|NCT01517373|B4|Baseline|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161366|NCT01517373|B3|Baseline|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161367|NCT01517373|B2|Baseline|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161368|NCT01517373|B1|Baseline|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161369|NCT01517373|P6|Participant Flow|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161370|NCT01517373|P5|Participant Flow|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161371|NCT01517373|P4|Participant Flow|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161372|NCT01517373|P3|Participant Flow|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161373|NCT01517373|P2|Participant Flow|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161374|NCT01517373|P1|Participant Flow|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
161375|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161376|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161377|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161378|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161379|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161380|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161381|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161382|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161383|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161384|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161385|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161386|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161387|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161501|NCT01517178|E1|Reported Event|Standard Care Base Plate|Safety population includes subjects allocated to test period (no run-in period)
161388|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161389|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161390|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161391|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161392|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161393|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161394|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161395|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161396|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161397|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161398|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161399|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161400|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161401|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161402|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161403|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161404|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161405|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161406|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161407|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161408|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161409|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161410|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161411|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161412|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161413|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161414|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161415|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161416|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161417|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161418|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161419|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161420|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161421|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161422|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161423|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161424|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161425|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161426|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161427|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161428|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161429|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161430|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161431|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161432|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161433|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161434|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161435|NCT01517373|E6|Reported Event|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161436|NCT01517373|E5|Reported Event|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161437|NCT01517373|E4|Reported Event|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161438|NCT01517373|E3|Reported Event|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161439|NCT01517373|E2|Reported Event|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
161440|NCT01517373|E1|Reported Event|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
161441|NCT01517295|B3|Baseline|Total|Total of all reporting groups
161442|NCT01517295|B2|Baseline|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161443|NCT01517295|B1|Baseline|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161444|NCT01517295|P2|Participant Flow|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161445|NCT01517295|P1|Participant Flow|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161446|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161447|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161448|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161449|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161686|NCT01516034|O1|Outcome|Treatment|Cupola tattoo removal treatment
161450|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161451|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161452|NCT01517295|E2|Reported Event|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161453|NCT01517295|E1|Reported Event|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.
Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
161454|NCT01517282|B5|Baseline|Total|Total of all reporting groups
161455|NCT01517282|B4|Baseline|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
161456|NCT01517282|B3|Baseline|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161457|NCT01517282|B2|Baseline|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161458|NCT01517282|B1|Baseline|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161459|NCT01517282|P4|Participant Flow|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
161460|NCT01517282|P3|Participant Flow|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161461|NCT01517282|P2|Participant Flow|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161462|NCT01517282|P1|Participant Flow|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161463|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
161464|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161465|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161466|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161467|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
161468|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161469|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161470|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161471|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161472|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161473|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161474|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161475|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161476|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161477|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161478|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161479|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161480|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161481|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161482|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161483|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
161484|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161485|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161486|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161487|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
161488|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161489|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161490|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161491|NCT01517282|E4|Reported Event|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
161492|NCT01517282|E3|Reported Event|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161493|NCT01517282|E2|Reported Event|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161494|NCT01517282|E1|Reported Event|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
161495|NCT01517178|B1|Baseline|Intention-to-treat Analysis Set|
161496|NCT01517178|P2|Participant Flow|New Ostomy Base Plate - Standard Care|Subjects first test New ostomy base plate then Standard Care.
161497|NCT01517178|P1|Participant Flow|Standard Care - New Ostomy Base Plate|Subjects first test Standard Care then New ostomy base plate.
161498|NCT01517178|O2|Outcome|New Ostomy Base Plate|
161499|NCT01517178|O1|Outcome|Standard Care Base Plate|
161500|NCT01517178|E2|Reported Event|New Ostomy Base Plate|Safety population includes subjects allocated to run-in period and test period.
161557|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161558|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
163095|NCT01510158|B1|Baseline|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
161502|NCT01517074|B1|Baseline|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
161503|NCT01517074|P1|Participant Flow|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
161504|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).
Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
161505|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).
Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
161506|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).
Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
161507|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).
Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
161508|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).
Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
161509|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).
Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
161510|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).
Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
161555|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161556|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161687|NCT01516034|E1|Reported Event|Treatment|Cupola tattoo removal treatment
161511|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).
Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
161512|NCT01517074|E1|Reported Event|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
161513|NCT01516970|B3|Baseline|Total|Total of all reporting groups
161514|NCT01516970|B2|Baseline|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
161515|NCT01516970|B1|Baseline|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
161516|NCT01516970|P2|Participant Flow|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
161517|NCT01516970|P1|Participant Flow|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
161518|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
161519|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
161520|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
161521|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
161522|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
161523|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
161688|NCT01516008|B4|Baseline|Total|Total of all reporting groups
161524|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
161525|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
161526|NCT01516970|E2|Reported Event|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
161527|NCT01516970|E1|Reported Event|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
161528|NCT01516892|B1|Baseline|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
161529|NCT01516892|P1|Participant Flow|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
161530|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
161531|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
161532|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
161533|NCT01516892|E1|Reported Event|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
161534|NCT01516879|B3|Baseline|Total|Total of all reporting groups
161535|NCT01516879|B2|Baseline|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161536|NCT01516879|B1|Baseline|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161537|NCT01516879|P2|Participant Flow|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161538|NCT01516879|P1|Participant Flow|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161539|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161540|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161541|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161542|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161543|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161544|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161545|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161546|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161547|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161548|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161549|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161550|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161551|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161552|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161553|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161554|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161559|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161560|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161561|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161562|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161563|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161564|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161565|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161566|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161567|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161568|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161569|NCT01516879|E2|Reported Event|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161570|NCT01516879|E1|Reported Event|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
161571|NCT01516749|B1|Baseline|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
161572|NCT01516749|P1|Participant Flow|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
161573|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
161574|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
161575|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
161576|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
161577|NCT01516749|E1|Reported Event|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
161578|NCT01516736|B3|Baseline|Total|Total of all reporting groups
161579|NCT01516736|B2|Baseline|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
161580|NCT01516736|B1|Baseline|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
161581|NCT01516736|P2|Participant Flow|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
161582|NCT01516736|P1|Participant Flow|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
161583|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
161584|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
161585|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
161586|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
161587|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
161588|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
161589|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
161590|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
161591|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
161592|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
161593|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
161594|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
161595|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
161596|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
161597|NCT01516736|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
161598|NCT01516736|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
161599|NCT01516736|E2|Reported Event|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
161600|NCT01516736|E1|Reported Event|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application."
161601|NCT01516632|B3|Baseline|Total|Total of all reporting groups
161602|NCT01516632|B2|Baseline|The Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
161603|NCT01516632|B1|Baseline|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
161604|NCT01516632|P2|Participant Flow|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
161605|NCT01516632|P1|Participant Flow|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
161628|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161629|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
161606|NCT01516632|O2|Outcome|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
161607|NCT01516632|O1|Outcome|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
161608|NCT01516632|O2|Outcome|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
161609|NCT01516632|O1|Outcome|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
161610|NCT01516632|O2|Outcome|Attention Matched Control|"Messages aimed at improving one's sleep and increasing one's fitness, along with general messages about the most well known health dangers of smoking. Messages sent on the same schedule as the intervention group.
SMS (Stop my Smoking) USA: Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again."
161611|NCT01516632|O1|Outcome|Smoking Cesssation Via Text Messaging|"The 6-week smoking cessation program
SMS (Stop my Smoking) USA: Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again."
161612|NCT01516632|E2|Reported Event|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
161613|NCT01516632|E1|Reported Event|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
161614|NCT01516437|B5|Baseline|Total|Total of all reporting groups
161615|NCT01516437|B4|Baseline|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161616|NCT01516437|B3|Baseline|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161617|NCT01516437|B2|Baseline|HS Group|Healthy smokers aged between 45-75 years
161618|NCT01516437|B1|Baseline|HNS Group|Healthy non-smokers aged between 45-75 years
161619|NCT01516437|P4|Participant Flow|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161620|NCT01516437|P3|Participant Flow|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161621|NCT01516437|P2|Participant Flow|HS Group|Healthy smokers aged between 45-75 years
161622|NCT01516437|P1|Participant Flow|HNS Group|Healthy non-smokers aged between 45-75 years
161623|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161624|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161625|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
161626|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
161627|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161631|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161632|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161633|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161634|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161635|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
161636|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
161637|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161638|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161639|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
161640|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
161641|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161642|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161643|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161644|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161645|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
161646|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
161647|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161648|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161649|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161650|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161651|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
161652|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
161653|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161654|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161655|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161656|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161657|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
161658|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
161659|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161660|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161661|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161662|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161663|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
161664|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
161665|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161666|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161667|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161668|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161669|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
161670|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
161671|NCT01516437|E4|Reported Event|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
161672|NCT01516437|E3|Reported Event|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
161673|NCT01516437|E2|Reported Event|HS Group|Healthy smokers aged between 45-75 years
161689|NCT01516008|B3|Baseline|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161690|NCT01516008|B2|Baseline|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161691|NCT01516008|B1|Baseline|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161695|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161696|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161697|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161698|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161699|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161700|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161701|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161702|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161703|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161704|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161705|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161706|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161707|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161708|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161709|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161710|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161711|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161712|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161713|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161714|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161715|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161716|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161717|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161718|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161719|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161720|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161721|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161722|NCT01516008|E3|Reported Event|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161723|NCT01516008|E2|Reported Event|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
161724|NCT01516008|E1|Reported Event|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
161725|NCT01515956|B1|Baseline|BMN110 2.0 mg/kg/Week|2.0 mg/kg/week
161726|NCT01515956|P1|Participant Flow|BMN110 2.0 mg/kg/Week|Weekly intravenous infusions of BMN 110 at a dose of 2.0 mg/kg for 52 consecutive weeks. Each infusion will be administered over a period of approximately 4 hours.
161727|NCT01515956|O1|Outcome|BMN110 2.0 mg/kg/Week|Weekly intravenous infusions of BMN 110 at a dose of 2.0 mg/kg for 52 consecutive weeks. Each infusion will be administered over a period of approximately 4 hours.
161728|NCT01515956|O1|Outcome|BMN110 2.0 mg/kg/Week|Weekly intravenous infusions of BMN 110 at a dose of 2.0 mg/kg for 52 consecutive weeks. Each infusion will be administered over a period of approximately 4 hours.
161729|NCT01515956|O1|Outcome|BMN110 2.0 mg/kg/Week|BMN110 2.0 mg/kg/week
161730|NCT01515956|E1|Reported Event|BMN110 2.0 mg/kg/Week|BMN110 2.0 mg/kg/week
161731|NCT01515943|B4|Baseline|Total|Total of all reporting groups
161743|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161744|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161745|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161746|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161747|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161748|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
162217|NCT01514149|O1|Outcome|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
161732|NCT01515943|B3|Baseline|Placebo|"The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.
Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.
Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5"
161733|NCT01515943|B2|Baseline|Near Target Push-up (NTP)|"The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.
Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times. Please refer to the pr"
161734|NCT01515943|B1|Baseline|Computer-based Therapy (CBT)|"The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.
Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.
Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment"
161735|NCT01515943|P3|Participant Flow|Placebo|"The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.
Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.
Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5"
161736|NCT01515943|P2|Participant Flow|Near Target Push-up (NTP)|"The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.
Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times."
161737|NCT01515943|P1|Participant Flow|Computer-based Therapy (CBT)|"The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.
Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.
Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment"
161738|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161739|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161740|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161741|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161742|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161932|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161749|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161750|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161751|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161752|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161753|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161754|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161755|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161756|NCT01515943|O2|Outcome|HB-C (Did Not Complete Computer-based Therapy Program)|Participants in the HB-C treatment group who did not complete the computer vergence/accommodative therapy (CVAT) program at 12 weeks, defined as achieving <15 stars for the jump vergence exercise.
161757|NCT01515943|O1|Outcome|HB-C (Completed Computer-based Therapy Program)|Participants in the HB-C treatment group who completed the computer vergence/accommodative therapy (CVAT) program at 12 weeks, defined as achieving at least 15 stars for the jump vergence exercise).
161758|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161759|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161760|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161761|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161762|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161763|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161764|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161765|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161766|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161767|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161768|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161769|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161770|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161771|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161772|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161773|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
165471|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
161774|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161775|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161776|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161777|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161778|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161779|NCT01515943|E3|Reported Event|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161780|NCT01515943|E2|Reported Event|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
161781|NCT01515943|E1|Reported Event|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
161782|NCT01515891|B1|Baseline|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).
BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
161783|NCT01515891|P1|Participant Flow|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).
BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
161784|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).
BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
161785|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).
BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
161786|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).
BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
161787|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).
BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
161788|NCT01515891|E1|Reported Event|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).
BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
161789|NCT01515865|B1|Baseline|Enrolled Population|
161790|NCT01515865|P3|Participant Flow|Placebo - (Randomized)|On Day 16 subjects received matching placebo.
161791|NCT01515865|P2|Participant Flow|Midodrine HCl - (Randomized)|On Day 16 subjects received over-encapsulated midodrine HCl tablets (equivalent to their previously prescribed dose).
161792|NCT01515865|P1|Participant Flow|Midodrine HCl - (Open-label)|On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld. On Day 2, all eligible subjects continued on their midodrine HCl dose regimen over at least 14 days, using study-supplied investigational product.
161793|NCT01515865|O2|Outcome|Placebo|Matching placebo treatment (utilizing the same number of placebo capsules that would be required to constitute their midodrine HCl dose).
161794|NCT01515865|O1|Outcome|Midodrine HCl|Over-encapsulated midodrine HCl tablet at the subjects previously prescribed dose level.
161795|NCT01515865|E4|Reported Event|Placebo - Randomized (Part C)|over-encapsulated randomized matching placebo
161796|NCT01515865|E3|Reported Event|Midodrine HCl - Randomized (Part C)|over-encapsulated randomized dose (Part C) at subjects current dose level
161797|NCT01515865|E2|Reported Event|Midodrine HCl - Open-label (Part B)|open-label study-supplied (Part B) dose at subjects current dose level
161798|NCT01515865|E1|Reported Event|Midodrine HCl - Open-label (Part A)|dose at the subjects current dose level
161799|NCT01515696|B3|Baseline|Total|Total of all reporting groups
161800|NCT01515696|B2|Baseline|Sterile Water|infants receive 9ml/kg sterile water
161801|NCT01515696|B1|Baseline|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
161802|NCT01515696|P2|Participant Flow|Sterile Water|infants received 9ml/kg sterile water once during the first 24 hours of life via gastric tube
161803|NCT01515696|P1|Participant Flow|Gastrografin|infants received 3ml/kg Gastrografin + 6ml/kg sterile water once during the first 24 hours of life via gastric tube
161804|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
161805|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
161806|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
161807|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
161808|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
161809|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
161810|NCT01515696|E2|Reported Event|Sterile Water|infants receive 9ml/kg sterile water
161811|NCT01515696|E1|Reported Event|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
161812|NCT01515657|B1|Baseline|All Study Participants|All patients that received at least 1 dose of study drug under the study protocol.
161851|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)
Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
161813|NCT01515657|P3|Participant Flow|EC Aspirin First, Then PL2200 Aspirin, Then IR Aspirin Tablets|"First Intervention Period:
EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Second Intervention Period:
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Third Intervention Period:
IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days"
161854|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)
Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
162218|NCT01514149|E5|Reported Event|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
161814|NCT01515657|P2|Participant Flow|IR Aspirin Tablets First, Then EC Aspirin, Then PL2200 Aspirin|"First Intervention Period:
IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Second Intervention Period:
EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Third Intervention Period:
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
161815|NCT01515657|P1|Participant Flow|PL2200 Aspirin First, Then IR Aspirin Tablets, Then EC Aspirin|"First Intervention Period:
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Second Intervention Period:
IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Third Intervention Period:
EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days"
161816|NCT01515657|O3|Outcome|Enteric-coated Aspirin Caplets|"Active comparator; crossover design
Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days"
161817|NCT01515657|O2|Outcome|Immediate-Release Aspirin Tablets|"Active comparator; crossover design
Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days"
161818|NCT01515657|O1|Outcome|PL2200 Aspirin Capsules|"Investigational drug arm; crossover design
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
161819|NCT01515657|E3|Reported Event|Enteric-coated Aspirin Caplets|"Active comparator; crossover design
Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days"
161820|NCT01515657|E2|Reported Event|Immediate-Release Aspirin Tablets|"Active comparator; crossover design
Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days"
161821|NCT01515657|E1|Reported Event|PL2200 Aspirin Capsules|"Investigational drug arm; crossover design
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
161822|NCT01515566|B3|Baseline|Total|Total of all reporting groups
161823|NCT01515566|B2|Baseline|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
161824|NCT01515566|B1|Baseline|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
161825|NCT01515566|P2|Participant Flow|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Placebo. Questionnaires completed at baseline and after study visit.
161826|NCT01515566|P1|Participant Flow|Fentanyl|Fentanyl subcutaneous (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Questionnaires completed at baseline and after study visit.
161827|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
161828|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
161829|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
161830|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
161831|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
161832|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
161833|NCT01515566|E2|Reported Event|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Placebo.
161834|NCT01515566|E1|Reported Event|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Fentanyl.
161835|NCT01515540|B3|Baseline|Total|Total of all reporting groups
161836|NCT01515540|B2|Baseline|Control|placebo patch
161837|NCT01515540|B1|Baseline|Lidocaine|5% lidoderm patch
161838|NCT01515540|P2|Participant Flow|Control|placebo patch
161839|NCT01515540|P1|Participant Flow|Lidocaine|5% lidoderm patch
161840|NCT01515540|O2|Outcome|Control|placebo patch
161841|NCT01515540|O1|Outcome|Lidocaine|5% lidoderm patch
161842|NCT01515540|E2|Reported Event|Control|placebo patch
161843|NCT01515540|E1|Reported Event|Lidocaine|5% lidoderm patch
161844|NCT01515488|B3|Baseline|Total|Total of all reporting groups
161845|NCT01515488|B2|Baseline|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)
Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
161846|NCT01515488|B1|Baseline|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)
Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
161847|NCT01515488|P2|Participant Flow|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)
Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
161848|NCT01515488|P1|Participant Flow|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)
Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
161849|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)
Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
161850|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)
Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
161852|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)
Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
161853|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)
Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
161855|NCT01515488|E2|Reported Event|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)
Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
161856|NCT01515488|E1|Reported Event|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)
Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
161857|NCT01515423|B3|Baseline|Total|Total of all reporting groups
161858|NCT01515423|B2|Baseline|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
161859|NCT01515423|B1|Baseline|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
161860|NCT01515423|P3|Participant Flow|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
161861|NCT01515423|P2|Participant Flow|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
161862|NCT01515423|P1|Participant Flow|Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.
161863|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
161864|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
161865|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
161866|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
161867|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
161868|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
161869|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
161870|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
161871|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
161872|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
162212|NCT01514149|O1|Outcome|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
161873|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
161874|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
161875|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
161876|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
161877|NCT01515423|E3|Reported Event|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
161878|NCT01515423|E2|Reported Event|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
161879|NCT01515423|E1|Reported Event|Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.
161880|NCT01515410|B1|Baseline|Overall Study|DM-1992 first, then Sinemet IR; Sinemet IR first, then DM-1992
161881|NCT01515410|P2|Participant Flow|Sinemet IR First, Then DM-1992|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD) first, then DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
161882|NCT01515410|P1|Participant Flow|DM-1992 First, Then Sinemet IR|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) first, then Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
161883|NCT01515410|O2|Outcome|Sinemet IR|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
161884|NCT01515410|O1|Outcome|DM-1992|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
161885|NCT01515410|E2|Reported Event|Sinemet IR|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
161886|NCT01515410|E1|Reported Event|DM-1992|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
161887|NCT01515345|B3|Baseline|Total|Total of all reporting groups
161888|NCT01515345|B2|Baseline|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
161889|NCT01515345|B1|Baseline|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
161890|NCT01515345|P2|Participant Flow|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
161891|NCT01515345|P1|Participant Flow|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
161892|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
161893|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
161894|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
161895|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
161896|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
161897|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
161898|NCT01515345|E2|Reported Event|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
161899|NCT01515345|E1|Reported Event|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
161900|NCT01515306|B3|Baseline|Total|Total of all reporting groups
161901|NCT01515306|B2|Baseline|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.
Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.
*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
161930|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161931|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161902|NCT01515306|B1|Baseline|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.
Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
161935|NCT01515189|E2|Reported Event|3 MG/KG IPILIMUMAB|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
163096|NCT01510158|P3|Participant Flow|Placebo + Allopurinol|placebo qd plus allopurinol
161903|NCT01515306|P2|Participant Flow|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.
Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.
*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
161904|NCT01515306|P1|Participant Flow|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.
Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
161905|NCT01515306|O1|Outcome|Part A: Ramucirumab (IMC-1121B) (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
161906|NCT01515306|O1|Outcome|Part A: Ramucirumab (IMC-1121B) (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
161907|NCT01515306|O1|Outcome|Part B: Ramucirumab (IMC-1121B) (Cycle 1)|Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.
161908|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
161909|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 1)|Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
161910|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
161911|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 1)|Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
161912|NCT01515306|E2|Reported Event|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.
Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.
*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
161913|NCT01515306|E1|Reported Event|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.
Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
161914|NCT01515189|B3|Baseline|Total|Total of all reporting groups
161915|NCT01515189|B2|Baseline|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161916|NCT01515189|B1|Baseline|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161917|NCT01515189|P2|Participant Flow|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161918|NCT01515189|P1|Participant Flow|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161919|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161920|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161921|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161922|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161923|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161924|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161925|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161926|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161927|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161928|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161929|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161933|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161934|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
162219|NCT01514149|E4|Reported Event|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
161936|NCT01515189|E1|Reported Event|10 MG/KG IPILIMUMAB|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
161937|NCT01515072|B3|Baseline|Total|Total of all reporting groups
161938|NCT01515072|B2|Baseline|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161939|NCT01515072|B1|Baseline|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161940|NCT01515072|P2|Participant Flow|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161941|NCT01515072|P1|Participant Flow|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161942|NCT01515072|O2|Outcome|RIPC|The recipients in this group received one or more organs from donors in the RIPC arm of the RIPNOD trial
161943|NCT01515072|O1|Outcome|No RIPC|The recipients in this group received one or more organs from donors in the No RIPC arm of the RIPNOD trial.
161944|NCT01515072|O2|Outcome|RIPC|Kidneys in this group were recovered from donors in the RIPC arm.
161945|NCT01515072|O1|Outcome|No RIPC|Kidneys in this group were recovered from donors in the No RIPC arm.
161946|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161947|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161948|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161949|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161950|NCT01515072|O2|Outcome|Remote Ischemic Preconditioning|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161951|NCT01515072|O1|Outcome|No Remote Ischemic Preconditioning|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161965|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
162213|NCT01514149|O5|Outcome|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
191341|NCT01405794|O2|Outcome|32ppm Oral Silver|
162001|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
162002|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
161952|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161953|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161954|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161955|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161956|NCT01515072|O2|Outcome|RIPC|"Kidneys in this group were recovered from donors in the RIPC arm. Decisions regarding which kidneys were not and were pumped were made by the OPO.
Any discrepancy in the number of participants is attributed to missing data for some subjects."
161957|NCT01515072|O1|Outcome|No RIPC|"Kidneys in this group were recovered from donors in the No RIPC arm. Decisions regarding which kidneys were not and were pumped were made by the OPO.
Any discrepancy in the number of participants is attributed to missing data for some subjects."
161958|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161959|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161960|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first occurs immediately after brain death declaration and consent for organ donation. The second one immediately before of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention occurs at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.
Any discrepancy in the number of participants is attributed to missing data for some participants"
161961|NCT01515072|O1|Outcome|No RIPC|"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
Any discrepancy in the number of participants is attributed to missing data for some participants"
161962|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first occurs immediately after brain death declaration and consent for organ donation. The second one immediately before of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention occurs at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.
Any discrepancy in the number of participants is attributed to missing data for some participants"
161963|NCT01515072|O1|Outcome|No RIPC|"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
Any discrepancy in the number of participants is attributed to missing data for some participants"
161964|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
162467|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
161966|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161967|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161968|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161969|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161970|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161971|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161972|NCT01515072|O2|Outcome|RIPC|"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.
RIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb."
161973|NCT01515072|O1|Outcome|No RIPC|The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.
161974|NCT01515072|E6|Reported Event|RIPC, Donors|Donors in this group received two RIPC interventions
161975|NCT01515072|E5|Reported Event|No RIPC, Donors|Donors in this group did not receive remote ischemic preconditioning (RIPC)
161976|NCT01515072|E4|Reported Event|RIPC, All Organ Recipients|Recipients in this group received organs from donors who received two RIPC interventions
161977|NCT01515072|E3|Reported Event|No RIPC, All Organ Recipients|Recipients in this group received organs from donors who did not receive remote ischemic preconditioning (No RIPC)
161978|NCT01515072|E2|Reported Event|RIPC, Kidney Recipients|Recipients in this group received kidneys from donors who received two RIPC interventions
161979|NCT01515072|E1|Reported Event|No RIPC, Kidney Recipients|Recipients in this group received kidneys from donors who did not receive remote ischemic preconditioning (No RIPC group)
161980|NCT01515046|B1|Baseline|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
161981|NCT01515046|P1|Participant Flow|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
161999|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
162000|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
161982|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
161983|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
161984|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
161985|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
161986|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
161987|NCT01515046|E1|Reported Event|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
161988|NCT01514864|B3|Baseline|Total|Total of all reporting groups
161989|NCT01514864|B2|Baseline|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
161990|NCT01514864|B1|Baseline|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
161991|NCT01514864|P2|Participant Flow|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
161992|NCT01514864|P1|Participant Flow|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
161993|NCT01514864|O1|Outcome|Dasatinib, 140 mg|Participants with nonsmall-cell lung cancer (NSCLC) received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
161994|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
161995|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
161996|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
161997|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
161998|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
162003|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
162004|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
162005|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
162006|NCT01514864|E1|Reported Event|Dasatinib, 140 mg|Participants with nonsmall-cell lung cancer received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
162007|NCT01514760|B1|Baseline|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.
Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
162008|NCT01514760|P1|Participant Flow|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.
Mobile-based Asthma Action Plan : The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
162009|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.
Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
162010|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.
Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
162011|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.
Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
162012|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.
Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
162468|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162037|NCT01514461|P3|Participant Flow|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162013|NCT01514760|E1|Reported Event|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.
Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
162014|NCT01514734|B1|Baseline|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
162015|NCT01514734|P1|Participant Flow|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
162016|NCT01514734|O1|Outcome|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
162017|NCT01514734|E1|Reported Event|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
162018|NCT01514630|B1|Baseline|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.
Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
162019|NCT01514630|P1|Participant Flow|Creatine Monohydrate|14 female depressed methamphetamine users received 5 grams of creatine monohydrate daily for eight weeks. Participants were seen twice weekly after creatine was initiated. All participants met SCID-I/P criteria for lifetime methamphetamine dependence or for current methamphetamine dependence. After consent was obtained, the principal investigator administered the SCID-I/P and HAMD, and if a female met SCID-I/P criteria and scored > 15 on the HAMD, the following additional screening data were collected: Beck Anxiety Inventory, C-SSRS , vital signs, concomitant medications, self-report drug use over the past 48 hours for cigarettes, alcohol, cocaine, methamphetamine, marijuana, heroin and prescription controlled substances, urine drug screen for methamphetamine, opiates, benzodiazepines, marijuana and cocaine, pregnancy testing and attendance in outpatient treatment and/or 12 step programs.
162020|NCT01514630|O1|Outcome|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.
Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
162021|NCT01514630|E1|Reported Event|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.
Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
162022|NCT01514513|B3|Baseline|Total|Total of all reporting groups
162023|NCT01514513|B2|Baseline|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
162024|NCT01514513|B1|Baseline|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
162025|NCT01514513|P2|Participant Flow|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
162026|NCT01514513|P1|Participant Flow|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
162027|NCT01514513|O2|Outcome|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
162028|NCT01514513|O1|Outcome|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
162029|NCT01514513|O2|Outcome|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
162030|NCT01514513|O1|Outcome|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
162031|NCT01514513|E2|Reported Event|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
162032|NCT01514513|E1|Reported Event|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
162033|NCT01514461|B4|Baseline|Total|Total of all reporting groups
162034|NCT01514461|B3|Baseline|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162035|NCT01514461|B2|Baseline|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162036|NCT01514461|B1|Baseline|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162116|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162038|NCT01514461|P2|Participant Flow|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162039|NCT01514461|P1|Participant Flow|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162040|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162041|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162042|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162043|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162044|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162045|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162046|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162047|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162048|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162049|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162079|NCT01514448|P1|Participant Flow|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162469|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162050|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162051|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162052|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162053|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162054|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162055|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162056|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162057|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162058|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162059|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162060|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162061|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162062|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162080|NCT01514448|O2|Outcome|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162209|NCT01514149|O4|Outcome|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
162063|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162064|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162065|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162066|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162067|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162068|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162069|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162070|NCT01514461|O2|Outcome|LCQ908 20mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162071|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162072|NCT01514461|E3|Reported Event|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162073|NCT01514461|E2|Reported Event|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary.
162074|NCT01514461|E1|Reported Event|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
162075|NCT01514448|B3|Baseline|Total|Total of all reporting groups
162076|NCT01514448|B2|Baseline|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162077|NCT01514448|B1|Baseline|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162078|NCT01514448|P2|Participant Flow|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162081|NCT01514448|O1|Outcome|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162215|NCT01514149|O3|Outcome|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
162082|NCT01514448|O2|Outcome|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162083|NCT01514448|O1|Outcome|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162084|NCT01514448|O2|Outcome|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162085|NCT01514448|O1|Outcome|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162086|NCT01514448|O2|Outcome|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162087|NCT01514448|O1|Outcome|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162088|NCT01514448|O2|Outcome|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162089|NCT01514448|O1|Outcome|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162090|NCT01514448|E3|Reported Event|Everolimus All Patients|Everolimus - All Patients that failed 1st line SUN and 1st Line PAZ and was on Everolimus 10mg orally once daily
162091|NCT01514448|E2|Reported Event|1st Line PAZ|Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162092|NCT01514448|E1|Reported Event|1st Line SUN|Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
162093|NCT01514422|B1|Baseline|Minocycline|Minocycline 100 to 300mg per day for 8 weeks
162094|NCT01514422|P1|Participant Flow|Minocycline|Minocycline 100 to 300mg per day for 8 weeks
162095|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
162096|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
162097|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
162098|NCT01514422|E1|Reported Event|Minocycline|Minocycline for 8 weeks
162099|NCT01514318|B1|Baseline|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
162100|NCT01514318|P1|Participant Flow|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
162101|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
162102|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
162103|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
162104|NCT01514318|E1|Reported Event|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
162105|NCT01514292|B1|Baseline|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring(CGM) System Wearing for up to 7 days.
162106|NCT01514292|P1|Participant Flow|CGM Device|Dexcom CGM Device Wearing for up to 7 days
162107|NCT01514292|O1|Outcome|Real Time Continous Glucose Monitoring System|Real Time Continous Glucose Monitoring System Wearing for up to 7 days
162108|NCT01514292|E1|Reported Event|CGM Device|Dexcom CGM Device Wearing for up to 7 days
162109|NCT01514240|B3|Baseline|Total|Total of all reporting groups
162110|NCT01514240|B2|Baseline|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162111|NCT01514240|B1|Baseline|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162112|NCT01514240|P2|Participant Flow|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162113|NCT01514240|P1|Participant Flow|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162114|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162115|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
191342|NCT01405794|O1|Outcome|Placebo|
162117|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162118|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162119|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162120|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162121|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162122|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162123|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162124|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162125|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162126|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162127|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162128|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162129|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162130|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162131|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162132|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162133|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162134|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162135|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162136|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162137|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162138|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162139|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162140|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162141|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162142|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162143|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162210|NCT01514149|O3|Outcome|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
162144|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162145|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162146|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162147|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162148|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162149|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162150|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162151|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162152|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162153|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162154|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162155|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162156|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162157|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162158|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162159|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162160|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162161|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162162|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162163|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162164|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162165|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162166|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162167|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162168|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162169|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162170|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162211|NCT01514149|O2|Outcome|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
162171|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162172|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162173|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162174|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162175|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162176|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162177|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162178|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162179|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162180|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162181|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162182|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162183|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162184|NCT01514240|E2|Reported Event|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
162185|NCT01514240|E1|Reported Event|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
162186|NCT01514162|B1|Baseline|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
162187|NCT01514162|P1|Participant Flow|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
162188|NCT01514162|O1|Outcome|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
162189|NCT01514162|O1|Outcome|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
162190|NCT01514162|O1|Outcome|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
162191|NCT01514162|E1|Reported Event|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
162192|NCT01514149|B6|Baseline|Total|Total of all reporting groups
162193|NCT01514149|B5|Baseline|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
162194|NCT01514149|B4|Baseline|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
162195|NCT01514149|B3|Baseline|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
162196|NCT01514149|B2|Baseline|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
162197|NCT01514149|B1|Baseline|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
162198|NCT01514149|P5|Participant Flow|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
162199|NCT01514149|P4|Participant Flow|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
162200|NCT01514149|P3|Participant Flow|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
162201|NCT01514149|P2|Participant Flow|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
162202|NCT01514149|P1|Participant Flow|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
162203|NCT01514149|O5|Outcome|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
162204|NCT01514149|O4|Outcome|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
162205|NCT01514149|O3|Outcome|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
162206|NCT01514149|O2|Outcome|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
162207|NCT01514149|O1|Outcome|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
162208|NCT01514149|O5|Outcome|Arm 5 - Weekly Placebo|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
162214|NCT01514149|O4|Outcome|Arm 4 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
162216|NCT01514149|O2|Outcome|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
162220|NCT01514149|E3|Reported Event|Arm 3 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
162221|NCT01514149|E2|Reported Event|Arm 2 - Weekly CJC-1134-PC|CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
162222|NCT01514149|E1|Reported Event|Arm 1 - Weekly CJC-1134-PC|CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
162223|NCT01514136|B3|Baseline|Total|Total of all reporting groups
162224|NCT01514136|B2|Baseline|Flat Product Users|Subjects who usually use a flat product
162225|NCT01514136|B1|Baseline|Convex Product Users|Subjects who usually use a convex product
162226|NCT01514136|P8|Participant Flow|Test D*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Therefore the participant flow is divided by the test products and not for each period.
Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
162227|NCT01514136|P7|Participant Flow|Test C*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Therefore the participant flow is divided by the test products and not for each period.
Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
162228|NCT01514136|P6|Participant Flow|Test B*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Therefore the participant flow is divided by the test products and not for each period.
Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
162229|NCT01514136|P5|Participant Flow|Test A*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Therefore the participant flow is divided by the test products and not for each period.
Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
162230|NCT01514136|P4|Participant Flow|Test D|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Therefore the participant flow is divided by the test products and not for each period.
Test D was a newly developed concept by Coloplast A/S for the first round."
162231|NCT01514136|P3|Participant Flow|Test C|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Therefore the participant flow is divided by the test products and not for each period.
Test C was a newly developed concept by Coloplast A/S for the first round."
162232|NCT01514136|P2|Participant Flow|Test B|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Therefore the participant flow is divided by the test products and not for each period.
Test B was a newly developed concept by Coloplast A/S for the first round."
162233|NCT01514136|P1|Participant Flow|Test A|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Therefore the participant flow is divided by the test products and not for each period.
Test A was a newly developed concept by Coloplast A/S for the first round."
162234|NCT01514136|O16|Outcome|Test D* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
162235|NCT01514136|O15|Outcome|Test C* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
162236|NCT01514136|O14|Outcome|Test B* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
162237|NCT01514136|O13|Outcome|Test A* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
162255|NCT01514136|E3|Reported Event|Test C|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.
Test C was a newly developed concept by Coloplast A/S for the first round."
162238|NCT01514136|O12|Outcome|Test D - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test D was a newly developed concept by Coloplast A/S for the first round."
162239|NCT01514136|O11|Outcome|Test C - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test C was a newly developed concept by Coloplast A/S for the first round."
162240|NCT01514136|O10|Outcome|Test B - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test B was a newly developed concept by Coloplast A/S for the first round."
162241|NCT01514136|O9|Outcome|Test A - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test A was a newly developed concept by Coloplast A/S for the first round."
162242|NCT01514136|O8|Outcome|Test D* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
162243|NCT01514136|O7|Outcome|Test C* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
162244|NCT01514136|O6|Outcome|Test B* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
162245|NCT01514136|O5|Outcome|Test A* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
162246|NCT01514136|O4|Outcome|Test D - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test D was a newly developed concept by Coloplast A/S for the first round."
162247|NCT01514136|O3|Outcome|Test C - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test C was a newly developed concept by Coloplast A/S for the first round."
162248|NCT01514136|O2|Outcome|Test B - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test B was a newly developed concept by Coloplast A/S for the first round."
162249|NCT01514136|O1|Outcome|Test A - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test A was a newly developed concept by Coloplast A/S for the first round."
162250|NCT01514136|E8|Reported Event|Test D*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.
Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
162251|NCT01514136|E7|Reported Event|Test C*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.
Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
162252|NCT01514136|E6|Reported Event|Test B*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.
Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
162253|NCT01514136|E5|Reported Event|Test A*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.
Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
162254|NCT01514136|E4|Reported Event|Test D|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.
Test D was a newly developed concept by Coloplast A/S for the first round."
162256|NCT01514136|E2|Reported Event|Test B|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.
Test B was a newly developed concept by Coloplast A/S for the first round."
162257|NCT01514136|E1|Reported Event|Test A|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.
Test A was a newly developed concept by Coloplast A/S for the first round."
162258|NCT01513902|B4|Baseline|Total|Total of all reporting groups
162423|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
162259|NCT01513902|B3|Baseline|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162260|NCT01513902|B2|Baseline|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162261|NCT01513902|B1|Baseline|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162262|NCT01513902|P3|Participant Flow|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162263|NCT01513902|P2|Participant Flow|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162264|NCT01513902|P1|Participant Flow|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162265|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162266|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162267|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162268|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162269|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162270|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162271|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162272|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162273|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162274|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162275|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162276|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162277|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162278|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162279|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162280|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162281|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162282|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162283|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162284|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162285|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162286|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162287|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162288|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162289|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162290|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162291|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162292|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162293|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162294|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162295|NCT01513902|E3|Reported Event|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162296|NCT01513902|E2|Reported Event|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
162297|NCT01513902|E1|Reported Event|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
162298|NCT01513590|B3|Baseline|Total|Total of all reporting groups
162299|NCT01513590|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
162300|NCT01513590|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
162301|NCT01513590|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
162302|NCT01513590|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
162303|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
162304|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
162305|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
162306|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
162307|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
162308|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
162309|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
162310|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
162311|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
162312|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
162313|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
162314|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
162315|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
162316|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
162317|NCT01513590|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
162318|NCT01513590|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
162319|NCT01513473|B3|Baseline|Total|Total of all reporting groups
162320|NCT01513473|B2|Baseline|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162321|NCT01513473|B1|Baseline|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162322|NCT01513473|P2|Participant Flow|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162323|NCT01513473|P1|Participant Flow|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162324|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162325|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162417|NCT01513291|P3|Participant Flow|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
162326|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162424|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
162327|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162328|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162329|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162330|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162331|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162332|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162333|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162334|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162335|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162336|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162337|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162338|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162339|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162340|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162418|NCT01513291|P2|Participant Flow|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
162470|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162341|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162342|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162343|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162344|NCT01513473|E2|Reported Event|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
162345|NCT01513473|E1|Reported Event|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
162346|NCT01513460|B4|Baseline|Total|Total of all reporting groups
162347|NCT01513460|B3|Baseline|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162348|NCT01513460|B2|Baseline|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162349|NCT01513460|B1|Baseline|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162350|NCT01513460|P3|Participant Flow|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162351|NCT01513460|P2|Participant Flow|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162352|NCT01513460|P1|Participant Flow|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162353|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162354|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162355|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162419|NCT01513291|P1|Participant Flow|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
162471|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162356|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162357|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162358|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162359|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162360|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162361|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162362|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162363|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162364|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162365|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162366|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162367|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162368|NCT01513460|O2|Outcome|NVA237/Tiotropium+Flu/Sal|NVA237+Flu/Sal and Tiotropium+Flu/Sal arms
162369|NCT01513460|O1|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162370|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162420|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
162425|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
162426|NCT01513291|O5|Outcome|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
162371|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162372|NCT01513460|E3|Reported Event|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162373|NCT01513460|E2|Reported Event|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162374|NCT01513460|E1|Reported Event|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
162375|NCT01513447|B3|Baseline|Total|Total of all reporting groups
162376|NCT01513447|B2|Baseline|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.
Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
162377|NCT01513447|B1|Baseline|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.
Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
162378|NCT01513447|P2|Participant Flow|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.
Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
162379|NCT01513447|P1|Participant Flow|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.
Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
162380|NCT01513447|O2|Outcome|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.
Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
162381|NCT01513447|O1|Outcome|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.
Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
162382|NCT01513447|O2|Outcome|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.
Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
162421|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
162383|NCT01513447|O1|Outcome|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.
Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
162384|NCT01513447|E2|Reported Event|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.
Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
162385|NCT01513447|E1|Reported Event|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.
Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
162386|NCT01513330|B1|Baseline|Entire Study Population|Entire study population = all participants enrolled in the study
162387|NCT01513330|P2|Participant Flow|First Standard Care, Then SenSura Mio|The subjects first test Standard Care Ostomy product 1 piece closed bags (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)and after cross-over test SenSura Mio 1-piece closed bags.
162388|NCT01513330|P1|Participant Flow|First SenSura Mio, Then Standard Care|The subjects first test SenSura Mio : Ostomy product - 1 piece closed bag and thereafter cross-over and test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)
162389|NCT01513330|O2|Outcome|Standard Care|Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
162390|NCT01513330|O1|Outcome|SenSura Mio|SenSura Mio : Ostomy product - 1 piece closed bag
162391|NCT01513330|E2|Reported Event|Standard Care|Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
162392|NCT01513330|E1|Reported Event|SenSura Mio|SenSura Mio : Ostomy product - 1 piece closed bag
162393|NCT01513317|B3|Baseline|Total|Total of all reporting groups
162394|NCT01513317|B2|Baseline|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162395|NCT01513317|B1|Baseline|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162396|NCT01513317|P2|Participant Flow|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162397|NCT01513317|P1|Participant Flow|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162398|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162399|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162400|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162401|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162402|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162403|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162404|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162405|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162406|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162407|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162408|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162409|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162410|NCT01513317|E2|Reported Event|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162411|NCT01513317|E1|Reported Event|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
162412|NCT01513291|B3|Baseline|Total|Total of all reporting groups
162413|NCT01513291|B2|Baseline|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
162414|NCT01513291|B1|Baseline|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
162415|NCT01513291|P5|Participant Flow|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
162416|NCT01513291|P4|Participant Flow|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
162422|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
162427|NCT01513291|O4|Outcome|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
162428|NCT01513291|O3|Outcome|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
162429|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
162430|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
162431|NCT01513291|O5|Outcome|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
162432|NCT01513291|O4|Outcome|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
162433|NCT01513291|O3|Outcome|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
162434|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
162435|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
162436|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
162437|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
162438|NCT01513291|E5|Reported Event|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
162439|NCT01513291|E4|Reported Event|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
162440|NCT01513291|E3|Reported Event|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
162441|NCT01513291|E2|Reported Event|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
162442|NCT01513291|E1|Reported Event|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
162443|NCT01513239|B4|Baseline|Total|Total of all reporting groups
162444|NCT01513239|B3|Baseline|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162445|NCT01513239|B2|Baseline|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162446|NCT01513239|B1|Baseline|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162447|NCT01513239|P3|Participant Flow|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162448|NCT01513239|P2|Participant Flow|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162449|NCT01513239|P1|Participant Flow|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162450|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162451|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162452|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162453|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162454|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162455|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162456|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162457|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162458|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162459|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162460|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162461|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162462|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162463|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162464|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162465|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162466|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162473|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162474|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162475|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162476|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162477|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162478|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162479|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162482|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162483|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162484|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162485|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162486|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162487|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162488|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162489|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162490|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162491|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
162492|NCT01513239|E4|Reported Event|MK-3415 + SOC|Single IV infusion of 10 mg/kg MK-3415 + SOC for CDI
162493|NCT01513239|E3|Reported Event|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
162494|NCT01513239|E2|Reported Event|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
162495|NCT01513239|E1|Reported Event|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
162496|NCT01513148|B3|Baseline|Total|Total of all reporting groups
162497|NCT01513148|B2|Baseline|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
162498|NCT01513148|B1|Baseline|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
162499|NCT01513148|P2|Participant Flow|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
162500|NCT01513148|P1|Participant Flow|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
162501|NCT01513148|O14|Outcome|Sham Temp Time 10|Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
162502|NCT01513148|O13|Outcome|Sham Temp Time 8|Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
162503|NCT01513148|O12|Outcome|Sham Temp Time 6|Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
162504|NCT01513148|O11|Outcome|Sham Temp Time 4|Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
162505|NCT01513148|O10|Outcome|Sham Temp Time 2|Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
162506|NCT01513148|O9|Outcome|Sham Temp Time 0|Temperature immediately following the application of sham superluminous diodes light irradiation over the superficial radial nerve
162507|NCT01513148|O8|Outcome|Sham Temp Pretreatment|Temperature prior to the application of sham super luminous diodes light irradiation over the superficial radial nerve
162508|NCT01513148|O7|Outcome|Light Temp Time 10|Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
162509|NCT01513148|O6|Outcome|Light Temp Time 8|Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
162510|NCT01513148|O5|Outcome|Light Temp Time 6|Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
162511|NCT01513148|O4|Outcome|Light Temp Time 4|Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
162512|NCT01513148|O3|Outcome|Light Temp Time 2|Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
162513|NCT01513148|O2|Outcome|Light Temp Time 0|Temperature immediately following the application of superluminous diodes light irradiation over the superficial radial nerve
162514|NCT01513148|O1|Outcome|Light Temp Pretreatment|Temperature prior to the application of super luminous diodes light irradiation over the superficial radial nerve
162515|NCT01513148|O14|Outcome|Sham NPL Pretreatment|NPL for Sham treatment group (Sham Superluminous diode light therapy) at baseline (pretreatment)
162516|NCT01513148|O13|Outcome|Sham NPL Time 10|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 10 minutes
162517|NCT01513148|O12|Outcome|Sham NPL Time 8|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 8 minutes
162518|NCT01513148|O11|Outcome|Sham NPL Time 6|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 6 minutes
162519|NCT01513148|O10|Outcome|Sham NPL Time 4|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 4 minutes
162520|NCT01513148|O9|Outcome|Sham NPL Time 2|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 2 minutes
162521|NCT01513148|O8|Outcome|Sham NPL Time 0|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 0 minutes
162522|NCT01513148|O7|Outcome|Light NPL Time 10|NPL for treatment group (Superluminous diode light therapy) at time 10 minutes
165472|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
162523|NCT01513148|O6|Outcome|Light NPL Time 8|NPL for treatment group (Superluminous diode light therapy) at time 8 minutes
162524|NCT01513148|O5|Outcome|Light NPL Time 6|NPL for treatment group (Superluminous diode light therapy) at time 6 minutes
162525|NCT01513148|O4|Outcome|Light NPL Time 4|NPL for treatment group (Superluminous diode light therapy) at time 4 minutes
162526|NCT01513148|O3|Outcome|Light NPL Time 2|NPL for treatment group (Superluminous diode light therapy) at time 2 minutes
162527|NCT01513148|O2|Outcome|Light NPL Time 0|NPL for treatment group (Superluminous diode light therapy) at time 0 minutes
162528|NCT01513148|O1|Outcome|Light NPL Pre-treatment|NPL for treatment group (Superluminous diode light therapy) at baseline (pre-treatment)
162529|NCT01513148|O14|Outcome|Sham NCV Time 10|NCV 10 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
162530|NCT01513148|O13|Outcome|Sham NCV Time 8|NCV 8 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
162531|NCT01513148|O12|Outcome|Sham NCV Time 6|NCV 6 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
162532|NCT01513148|O11|Outcome|Sham NCV Time 4|NCV 4 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
162533|NCT01513148|O10|Outcome|Sham NCV Time 2|NCV 2 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
162534|NCT01513148|O9|Outcome|Sham NCV Time 0|NCV immediately (Time 0) following the application of superluminous diodes light irradiation over the superficial radial nerve
162535|NCT01513148|O8|Outcome|Sham NCV Pretreatment|NCV at baseline, before the application of sham superluminous diodes light irradiation over the superficial radial nerve
162536|NCT01513148|O7|Outcome|Light NCV Time 10|NCV 10 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
162537|NCT01513148|O6|Outcome|Light NCV Time 8|NCV 8 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
162538|NCT01513148|O5|Outcome|Light NCV Time 6|NCV 6 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
162539|NCT01513148|O4|Outcome|Light NCV Time 4|NCV 4 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
162540|NCT01513148|O3|Outcome|Light NCV Time 2|NCV 2 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
162541|NCT01513148|O2|Outcome|Light NCV Time 0|NCV at time 0, immediately following the application of super luminous diodes light irradiation over the superficial radial nerve
162542|NCT01513148|O1|Outcome|Light NCV Pretreatment|NCV at baseline, before the application of super luminous diodes light irradiation over the superficial radial nerve
162543|NCT01513148|E2|Reported Event|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
162544|NCT01513148|E1|Reported Event|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
162545|NCT01513122|B3|Baseline|Total|Total of all reporting groups
162546|NCT01513122|B2|Baseline|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
162547|NCT01513122|B1|Baseline|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
162548|NCT01513122|P2|Participant Flow|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
162549|NCT01513122|P1|Participant Flow|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
162550|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
162551|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
162552|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
162553|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
162554|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
162555|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
162556|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
162557|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
162558|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
162559|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
162560|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
162561|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
162562|NCT01513122|E2|Reported Event|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
191343|NCT01405794|O2|Outcome|32ppm Oral Silver|
162563|NCT01513122|E1|Reported Event|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
162564|NCT01512979|B3|Baseline|Total|Total of all reporting groups
162565|NCT01512979|B2|Baseline|Linagliptin 5mg|Patients treated with linagliptin 5mg
162566|NCT01512979|B1|Baseline|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
162567|NCT01512979|P2|Participant Flow|Linagliptin 5mg|Patients treated with linagliptin 5mg
162568|NCT01512979|P1|Participant Flow|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
162569|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
163097|NCT01510158|P2|Participant Flow|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
162570|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
162571|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
162572|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
162573|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
162574|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
162575|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
162576|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
162577|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
162578|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
162579|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
162580|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
162581|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
162582|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
162583|NCT01512979|E2|Reported Event|Linagliptin 5mg|Patients treated with linagliptin 5mg
162584|NCT01512979|E1|Reported Event|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
162585|NCT01512849|B3|Baseline|Total|Total of all reporting groups
162586|NCT01512849|B2|Baseline|Entire Population for Normal Renal Function|
162587|NCT01512849|B1|Baseline|Entire Population for Moderate Renal Impairment|
162588|NCT01512849|P4|Participant Flow|Normal Renal Function High Dose First|TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2
162589|NCT01512849|P3|Participant Flow|Normal Renal Function Low Dose First|TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2
162590|NCT01512849|P2|Participant Flow|Moderate Renal Impairment High Dose First|TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2
162591|NCT01512849|P1|Participant Flow|Moderate Renal Impairment Low Dose First|TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2
162592|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
162593|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
162594|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
162595|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
162596|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
162597|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
162598|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
162599|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
162600|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
162601|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
162602|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
162603|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
162604|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
162605|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
162606|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
162607|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
162608|NCT01512849|E4|Reported Event|Normal Renal Function High|TA-7284-High was administered in a single dose.
162609|NCT01512849|E3|Reported Event|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
162610|NCT01512849|E2|Reported Event|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
162611|NCT01512849|E1|Reported Event|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
162612|NCT01512745|B3|Baseline|Total|Total of all reporting groups
162613|NCT01512745|B2|Baseline|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162614|NCT01512745|B1|Baseline|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162615|NCT01512745|P2|Participant Flow|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162616|NCT01512745|P1|Participant Flow|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162617|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
191344|NCT01405794|O1|Outcome|Placebo|
162618|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162619|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162620|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162621|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162622|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
163098|NCT01510158|P1|Participant Flow|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
162623|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162624|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162625|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162626|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162627|NCT01512745|E2|Reported Event|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162628|NCT01512745|E1|Reported Event|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
162629|NCT01512368|B1|Baseline|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
162630|NCT01512368|P1|Participant Flow|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
162631|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
162632|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
162633|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
162634|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
162635|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
162636|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
162637|NCT01512368|E1|Reported Event|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
162638|NCT01512225|B3|Baseline|Total|Total of all reporting groups
162639|NCT01512225|B2|Baseline|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
162640|NCT01512225|B1|Baseline|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days
Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
162641|NCT01512225|P2|Participant Flow|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
162642|NCT01512225|P1|Participant Flow|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days
Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
162643|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
162644|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days
Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
162645|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
162646|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days
Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
162647|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
162648|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days
Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
162649|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
162650|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days
Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
162814|NCT01511809|E1|Reported Event|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy
Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
162651|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
162652|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days
Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
162817|NCT01511536|B2|Baseline|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162653|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
162654|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days
Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
162655|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
162656|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days
Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
162657|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
162658|NCT01512225|O1|Outcome|Group A: Domperidone|Domperidone 10 mg orally three times daily for 28 days
162659|NCT01512225|E2|Reported Event|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
162660|NCT01512225|E1|Reported Event|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days
Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
162661|NCT01512160|B5|Baseline|Total|Total of all reporting groups
162662|NCT01512160|B4|Baseline|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162663|NCT01512160|B3|Baseline|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162664|NCT01512160|B2|Baseline|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162665|NCT01512160|B1|Baseline|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162666|NCT01512160|P4|Participant Flow|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162667|NCT01512160|P3|Participant Flow|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162668|NCT01512160|P2|Participant Flow|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162669|NCT01512160|P1|Participant Flow|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 milligram (mg) spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 millimeter (mm) on a 100 mm Visual Analogue Scale (VAS).
162670|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162671|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162672|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162673|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162815|NCT01511536|B4|Baseline|Total|Total of all reporting groups
162674|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162869|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162675|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162676|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162677|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162678|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162679|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162680|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162681|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162682|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162683|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162684|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162685|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162686|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162687|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162688|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162689|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162690|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162691|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162692|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
165473|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
162693|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162694|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162695|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162696|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162697|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162698|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162699|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162700|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162701|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162702|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162703|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162704|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162705|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162706|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162707|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162708|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162709|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162710|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162711|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
165474|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
162712|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162713|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162714|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162715|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162716|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162717|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162718|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162719|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162720|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162721|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162722|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162723|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162724|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162725|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162726|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162727|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162728|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162729|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162730|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
165475|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
162731|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162732|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162733|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162734|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162735|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162736|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162737|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162738|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162739|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162740|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162741|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162742|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162743|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162744|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162745|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162746|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162747|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162748|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162749|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
165476|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
162750|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162751|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162752|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162753|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162754|NCT01512160|E4|Reported Event|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162755|NCT01512160|E3|Reported Event|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162756|NCT01512160|E2|Reported Event|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162757|NCT01512160|E1|Reported Event|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
162758|NCT01512108|B3|Baseline|Total|Total of all reporting groups
162759|NCT01512108|B2|Baseline|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
162760|NCT01512108|B1|Baseline|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
162761|NCT01512108|P2|Participant Flow|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
162762|NCT01512108|P1|Participant Flow|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
162763|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
162764|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
162765|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
162766|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
162767|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
162768|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
162769|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
162770|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
162771|NCT01512108|E2|Reported Event|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
162816|NCT01511536|B3|Baseline|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162772|NCT01512108|E1|Reported Event|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
162773|NCT01511978|B3|Baseline|Total|Total of all reporting groups
162774|NCT01511978|B2|Baseline|3,4-DAP Taper to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
162775|NCT01511978|B1|Baseline|Continuous 3,4-Diaminopyridine (3,4-DAP)|Subjects were administered their usual dosage on their regular personalized schedule
162776|NCT01511978|P2|Participant Flow|Taper 3,4-DAP to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
162777|NCT01511978|P1|Participant Flow|Continuous 3,4-DAP|Subjects were administered their usual dosage on their regular personalized schedule
162778|NCT01511978|O2|Outcome|3,4-DAP Taper to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
162779|NCT01511978|O1|Outcome|3,4-DAP|Subjects were administered their usual dosage on their regular personalized schedule.
162780|NCT01511978|O2|Outcome|3,4-DAP Taper to Placebo|Subjects were tapered off of their pre-randomization 3,4-DAP dosing regimen over 3 days with up to an additional 16 hours of placebo.
162781|NCT01511978|O1|Outcome|Continuous 3,4-Diaminopyridine (3,4-DAP)|Subjects were continued on their usual pre-randomization 3,4-DAP dosing regimen.
162782|NCT01511978|E2|Reported Event|3,4-DAP Taper to Placebo|Subjects were administered decreasing amounts of 3,4-DAP on their regular personalized schedule
162783|NCT01511978|E1|Reported Event|Continuous 3,4-Diaminopyridine (3,4-DAP)|Subjects were administered their usual dosage on their regular personalized schedule
162784|NCT01511939|B4|Baseline|Total|Total of all reporting groups
162785|NCT01511939|B3|Baseline|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162786|NCT01511939|B2|Baseline|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162787|NCT01511939|B1|Baseline|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162788|NCT01511939|P3|Participant Flow|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162789|NCT01511939|P2|Participant Flow|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162790|NCT01511939|P1|Participant Flow|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis (OA) pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162791|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162792|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162793|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162794|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162795|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162796|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162797|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162798|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162799|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162800|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162801|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162802|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162803|NCT01511939|E3|Reported Event|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162804|NCT01511939|E2|Reported Event|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162805|NCT01511939|E1|Reported Event|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months
Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
162806|NCT01511809|B3|Baseline|Total|Total of all reporting groups
162807|NCT01511809|B2|Baseline|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
162808|NCT01511809|B1|Baseline|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy
Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
162809|NCT01511809|P2|Participant Flow|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
162810|NCT01511809|P1|Participant Flow|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy
Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
162811|NCT01511809|O2|Outcome|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
162812|NCT01511809|O1|Outcome|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy
Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
162813|NCT01511809|E2|Reported Event|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
162867|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162818|NCT01511536|B1|Baseline|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162819|NCT01511536|P3|Participant Flow|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at maximum tolerated dose (MTD) as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162820|NCT01511536|P2|Participant Flow|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162821|NCT01511536|P1|Participant Flow|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162822|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162823|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162824|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162825|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162826|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162827|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162828|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162829|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162830|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162831|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162832|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162833|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162834|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162835|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162836|NCT01511536|O1|Outcome|Phase 1: Overall Population|Cabazitaxel 20 or 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162837|NCT01511536|E3|Reported Event|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162870|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162838|NCT01511536|E2|Reported Event|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162839|NCT01511536|E1|Reported Event|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
162840|NCT01511445|B3|Baseline|Total|Total of all reporting groups
162841|NCT01511445|B2|Baseline|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
162842|NCT01511445|B1|Baseline|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
162843|NCT01511445|P2|Participant Flow|ACDF With PEEK Interbody Cage|"Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure.
Anterior cervical discectomy and fusion (ACDF) with PEEK Cage: Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer"
162844|NCT01511445|P1|Participant Flow|ACDF With Valeo CSC Ceramic Cage|"ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood.
Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage: Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer."
162845|NCT01511445|O2|Outcome|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
162846|NCT01511445|O1|Outcome|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
162847|NCT01511445|O2|Outcome|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
162848|NCT01511445|O1|Outcome|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
162849|NCT01511445|E2|Reported Event|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
162850|NCT01511445|E1|Reported Event|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
162851|NCT01511315|B1|Baseline|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
162852|NCT01511315|P1|Participant Flow|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
162853|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
162854|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
162855|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
162856|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
162857|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
162858|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
162859|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
162860|NCT01511315|E1|Reported Event|Ustekinumab|Ustekinumab: Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.
162861|NCT01511107|B3|Baseline|Total|Total of all reporting groups
162862|NCT01511107|B2|Baseline|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162863|NCT01511107|B1|Baseline|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162864|NCT01511107|P2|Participant Flow|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162865|NCT01511107|P1|Participant Flow|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162866|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
191345|NCT01405794|O2|Outcome|32ppm Oral Silver|
162868|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162964|NCT01510769|E2|Reported Event|Lesinurad 400 mg + Febuxostat|
162871|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162872|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162873|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162874|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162875|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162876|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162877|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162878|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162879|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162880|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162881|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162882|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162883|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162884|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162885|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162886|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162887|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162888|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162889|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162890|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162891|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162892|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162893|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162894|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162895|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162896|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162897|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162898|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162899|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162900|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162901|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162902|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162903|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162959|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
191346|NCT01405794|O1|Outcome|Placebo|
162904|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162905|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162906|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162907|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162908|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162909|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162910|NCT01511107|E2|Reported Event|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
162911|NCT01511107|E1|Reported Event|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
162912|NCT01511016|B3|Baseline|Total|Total of all reporting groups
162913|NCT01511016|B2|Baseline|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.
Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
162914|NCT01511016|B1|Baseline|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.
Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
162915|NCT01511016|P2|Participant Flow|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.
Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
162916|NCT01511016|P1|Participant Flow|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.
Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
162917|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.
Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
162918|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.
Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
162919|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.
Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
162920|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.
Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
162921|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.
Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
162922|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.
Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
162923|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.
Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
162924|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.
Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
162925|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.
Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
162926|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.
Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
162960|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
165477|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
162927|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.
Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
162965|NCT01510769|E1|Reported Event|Lesinurad 200 mg + Febuxostat|
163099|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
162928|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.
Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
162929|NCT01511016|E2|Reported Event|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.
Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
162930|NCT01511016|E1|Reported Event|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.
Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
162931|NCT01510912|B1|Baseline|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
162932|NCT01510912|P1|Participant Flow|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
162933|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
162934|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
162935|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
162936|NCT01510912|E1|Reported Event|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
162937|NCT01510834|B1|Baseline|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
162938|NCT01510834|P1|Participant Flow|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
162939|NCT01510834|O1|Outcome|Mean Difference in PHQ-8 (T1, T3)|Mean Difference in PHQ-8 (T1,T3) for study completers
162940|NCT01510834|O1|Outcome|Mean Difference in PSS (T1, T3)|Mean difference in Perceived Stress Scale (T1, T3) for study completers
162941|NCT01510834|O1|Outcome|Mean Difference in QOLS (T1, T3)|Mean Difference in QOLS (T1, T3)for study completers only
162942|NCT01510834|O1|Outcome|Mean Difference in PCL (T1, T3) (Negative Change is Better)|Mean difference in PCL (T1, T3) for study completers
162943|NCT01510834|E1|Reported Event|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
162944|NCT01510769|B4|Baseline|Total|Total of all reporting groups
162945|NCT01510769|B3|Baseline|Placebo + Febuxostat|
162946|NCT01510769|B2|Baseline|Lesinurad 400 mg + Febuxostat|
162947|NCT01510769|B1|Baseline|Lesinurad 200 mg + Febuxostat|
162948|NCT01510769|P3|Participant Flow|Placebo + Febuxostat|
162949|NCT01510769|P2|Participant Flow|Lesinurad 400 mg + Febuxostat|
162950|NCT01510769|P1|Participant Flow|Lesinurad 200 mg + Febuxostat|
162951|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
162952|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
162953|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
162954|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
162955|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
162956|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
162957|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
162958|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
163015|NCT01510704|E1|Reported Event|Placebo|
162961|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
162962|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
162963|NCT01510769|E3|Reported Event|Placebo + Febuxostat|
162966|NCT01510756|B1|Baseline|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).
Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
162967|NCT01510756|P1|Participant Flow|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).
Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
162968|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).
Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
162969|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).
Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
162970|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).
Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
162971|NCT01510756|E1|Reported Event|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).
Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
162972|NCT01510717|B3|Baseline|Total|Total of all reporting groups
162973|NCT01510717|B2|Baseline|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
162974|NCT01510717|B1|Baseline|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162975|NCT01510717|P2|Participant Flow|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
162976|NCT01510717|P1|Participant Flow|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162977|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
162978|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162979|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
162980|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162981|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
162982|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162983|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
162984|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162985|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
162986|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162987|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
162988|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162989|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
162990|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162991|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
162992|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162993|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162994|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
162995|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162996|NCT01510717|E3|Reported Event|Monofocal IOL|All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ Monofocal IOL Model SN60WF
162997|NCT01510717|E2|Reported Event|Multifocal IOL|All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
162998|NCT01510717|E1|Reported Event|Pre-Treatment|All enrolled participants
162999|NCT01510704|B5|Baseline|Total|Total of all reporting groups
163000|NCT01510704|B4|Baseline|High Dose APD421|20mg dose level
163001|NCT01510704|B3|Baseline|Mid Dose APD421|5mg dose level
163002|NCT01510704|B2|Baseline|Low Dose APD421|1mg dose level
163003|NCT01510704|B1|Baseline|Placebo|
163004|NCT01510704|P4|Participant Flow|High Dose APD421|20mg dose level
163005|NCT01510704|P3|Participant Flow|Mid Dose APD421|5mg dose level
163006|NCT01510704|P2|Participant Flow|Low Dose APD421|1mg dose level
163007|NCT01510704|P1|Participant Flow|Placebo|
163008|NCT01510704|O4|Outcome|High Dose APD421|20mg dose level
163009|NCT01510704|O3|Outcome|Mid Dose APD421|5mg dose level
163010|NCT01510704|O2|Outcome|Low Dose APD421|1mg dose level
163011|NCT01510704|O1|Outcome|Placebo|
163012|NCT01510704|E4|Reported Event|High Dose APD421|20mg dose level
163013|NCT01510704|E3|Reported Event|Mid Dose APD421|5mg dose level
163014|NCT01510704|E2|Reported Event|Low Dose APD421|1mg dose level
163017|NCT01510652|B2|Baseline|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)
Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
163064|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
163018|NCT01510652|B1|Baseline|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
163019|NCT01510652|P2|Participant Flow|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)
Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
163020|NCT01510652|P1|Participant Flow|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
163021|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)
Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
163022|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
163023|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)
Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
163024|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
163025|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)
Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
163026|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
163027|NCT01510652|E2|Reported Event|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)
Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
163028|NCT01510652|E1|Reported Event|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
163029|NCT01510457|B3|Baseline|Total|Total of all reporting groups
163030|NCT01510457|B2|Baseline|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
163031|NCT01510457|B1|Baseline|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
163032|NCT01510457|P2|Participant Flow|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
163033|NCT01510457|P1|Participant Flow|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
163034|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
163035|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
163036|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
163037|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
163038|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
163063|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
191347|NCT01405794|O2|Outcome|32ppm Oral Silver|
163065|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
163100|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
163039|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
163040|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
163041|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
163042|NCT01510457|O2|Outcome|Milnacipran|"Uptitration from 10mg to 50mg BID Milnacipran
Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used."
163043|NCT01510457|O1|Outcome|Sugar Pill|"BID placebo
Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication."
163044|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
163045|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
163046|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
163047|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
163048|NCT01510457|E2|Reported Event|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
163049|NCT01510457|E1|Reported Event|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
163050|NCT01510379|B3|Baseline|Total|Total of all reporting groups
163051|NCT01510379|B2|Baseline|Control|Scheduled ondansetron plus phenergan prn
163052|NCT01510379|B1|Baseline|Reletex|Reletex plus scheduled ondansetron and phenergan prn
163053|NCT01510379|P2|Participant Flow|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
163054|NCT01510379|P1|Participant Flow|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
163055|NCT01510379|O2|Outcome|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
163056|NCT01510379|O1|Outcome|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
163057|NCT01510379|O2|Outcome|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
163058|NCT01510379|O1|Outcome|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
163059|NCT01510379|E2|Reported Event|Control|Scheduled ondansetron plus phenergan prn
163060|NCT01510379|E1|Reported Event|Reletex|Reletex plus scheduled ondansetron and phenergan prn
163061|NCT01510327|B1|Baseline|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
163062|NCT01510327|P1|Participant Flow|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
163066|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
163067|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
163068|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
163069|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
163070|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163071|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163072|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163073|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163074|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163075|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163076|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163077|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163078|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163079|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163080|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163081|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163082|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163083|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163084|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163085|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163086|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163087|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
163088|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
163089|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
163090|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents
191348|NCT01405794|O1|Outcome|Placebo|
163091|NCT01510327|E1|Reported Event|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
163092|NCT01510158|B4|Baseline|Total|Total of all reporting groups
163093|NCT01510158|B3|Baseline|Placebo + Allopurinol|placebo qd plus allopurinol
163101|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
163102|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
163103|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
163104|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
163105|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
163106|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
163107|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
163108|NCT01510158|E3|Reported Event|Placebo + Allopurinol|placebo qd plus allopurinol
163109|NCT01510158|E2|Reported Event|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
163110|NCT01510158|E1|Reported Event|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
163111|NCT01510145|B1|Baseline|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
163112|NCT01510145|P1|Participant Flow|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
163113|NCT01510145|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
163114|NCT01510145|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
163115|NCT01510145|E1|Reported Event|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
163116|NCT01509807|B3|Baseline|Total|Total of all reporting groups
163117|NCT01509807|B2|Baseline|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163118|NCT01509807|B1|Baseline|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163119|NCT01509807|P2|Participant Flow|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163120|NCT01509807|P1|Participant Flow|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163121|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163122|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163123|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163124|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163125|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163126|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163127|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163128|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163198|NCT01509586|P2|Participant Flow|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
163220|NCT01509079|B2|Baseline|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
163221|NCT01509079|B1|Baseline|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
163129|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163130|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163131|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163132|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163133|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163134|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163135|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163136|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163137|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163138|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163139|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163140|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163141|NCT01509807|E2|Reported Event|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163142|NCT01509807|E1|Reported Event|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
163143|NCT01509664|B3|Baseline|Total|Total of all reporting groups
163144|NCT01509664|B2|Baseline|Control|Received no discount at the participating supermarket.
163145|NCT01509664|B1|Baseline|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.
Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
163146|NCT01509664|P2|Participant Flow|Control|Received no discount at the participating supermarket.
163147|NCT01509664|P1|Participant Flow|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.
Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
163148|NCT01509664|O2|Outcome|Control|Received no discount at the participating supermarket.
163149|NCT01509664|O1|Outcome|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.
Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
163150|NCT01509664|E2|Reported Event|Control|Received no discount at the participating supermarket.
163151|NCT01509664|E1|Reported Event|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.
Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
163152|NCT01509638|B3|Baseline|Total|Total of all reporting groups
163153|NCT01509638|B2|Baseline|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163154|NCT01509638|B1|Baseline|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163155|NCT01509638|P2|Participant Flow|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163156|NCT01509638|P1|Participant Flow|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163157|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163158|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163159|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163160|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163161|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163162|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163163|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163164|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163165|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163166|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163167|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163168|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163332|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163333|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163334|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163169|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163170|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163171|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163172|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163173|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163174|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163175|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163176|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163177|NCT01509638|E2|Reported Event|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
163178|NCT01509638|E1|Reported Event|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
163179|NCT01509625|B1|Baseline|One Arm of Metastatic RE Breast Cancer Patients|Women with metastatic breast cancer who have disease progresion after prior antiestrogen treatment. All tumors were positive estrogen receptors
163180|NCT01509625|P1|Participant Flow|One Arm of Metastatic Breast Cancer Patients|All the patients have tumors with positive estrogen receptors
163181|NCT01509625|O2|Outcome|Patients With Tumors ki67 Negative|Patients with tumors with low ki67 expression
163182|NCT01509625|O1|Outcome|Patients With Tumors ki67 Positive|Patients with tumors with high ki67 expression
163183|NCT01509625|O2|Outcome|Patients With Tumors HER2 Negative|tumor is considered HER2 negative if there is not a sobreexpression of the receptor by immunohistochemistry or FISH is positive
163184|NCT01509625|O1|Outcome|Patients With Tumors HER2 Positive|tumor is considered HER2 positive if there is a sobreexpression of the receptor by immunohistochemistry or FISH is positive
163185|NCT01509625|O2|Outcome|Previous Treatment With Two or More Hormonal Treatment Lines|The patients have received at least two hormonal treatment: tamoxifen and aromatase inhibitor
163186|NCT01509625|O1|Outcome|Previous Treatment Wiht One Line of Hormonal Treatment|Hormonal treatment was tamoxifen or an aromatase inhibitor
163187|NCT01509625|O2|Outcome|Patients With Visceral Metastasis|Group of patients with metastasis in organs like liver or lungs
163188|NCT01509625|O1|Outcome|Patients Without Visceral Metastasis|Group of patients without metastasis in organs like liver or lungs
163189|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
163190|NCT01509625|O1|Outcome|Patients With Clinical Benefit|Patients wich achieved a clinical benefit with fulvetrant 500: complete response, partial response or stable disease of 24 weeks or longer
163191|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
163192|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
163193|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
163194|NCT01509625|E1|Reported Event|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
163195|NCT01509586|B3|Baseline|Total|Total of all reporting groups
163196|NCT01509586|B2|Baseline|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
163335|NCT01508936|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163336|NCT01508936|E1|Reported Event|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163337|NCT01508910|B4|Baseline|Total|Total of all reporting groups
163338|NCT01508910|B3|Baseline|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
165478|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
163197|NCT01509586|B1|Baseline|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
163199|NCT01509586|P1|Participant Flow|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
163200|NCT01509586|O2|Outcome|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
163201|NCT01509586|O1|Outcome|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
163202|NCT01509586|E2|Reported Event|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
163203|NCT01509586|E1|Reported Event|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
163204|NCT01509105|B1|Baseline|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163205|NCT01509105|P1|Participant Flow|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163206|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163207|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163208|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
165479|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
163209|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163219|NCT01509079|B3|Baseline|Total|Total of all reporting groups
163210|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163211|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163212|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163213|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163214|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163215|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163216|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163217|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163339|NCT01508910|B2|Baseline|Active Control Arm|Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
163340|NCT01508910|B1|Baseline|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
163218|NCT01509105|E1|Reported Event|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
163222|NCT01509079|P2|Participant Flow|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
163223|NCT01509079|P1|Participant Flow|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
163224|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
163225|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
163226|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
163227|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
163228|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
163229|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
163230|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
163231|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
163232|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
163233|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
163234|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
163235|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
163236|NCT01509079|E2|Reported Event|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
163237|NCT01509079|E1|Reported Event|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
163238|NCT01509053|B1|Baseline|All Participants|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
163239|NCT01509053|P1|Participant Flow|Oral Aripiprazole Tablets and Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
163240|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
163241|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
163242|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
163341|NCT01508910|P4|Participant Flow|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
163342|NCT01508910|P3|Participant Flow|Unblinded Standard of Care (SOC) Arm|No study-related procedures were performed.
191349|NCT01405794|O2|Outcome|32ppm Oral Silver|
163243|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
163244|NCT01509053|O2|Outcome|Standard of Care|Patients who received oral antipsychotic treatment as standard of care in clinical practice.
163358|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
165007|NCT01499576|O1|Outcome|Acetic Acid Spraying|The same participants primary outcome analysed
163245|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
163246|NCT01509053|E3|Reported Event|Aripiprazole IM Depot (Phase C)|Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
163247|NCT01509053|E2|Reported Event|Aripiprazole IM Depot (Phase B)|In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
163248|NCT01509053|E1|Reported Event|Oral Aripiprazole (Phase A)|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot.
163249|NCT01509040|B4|Baseline|Total|Total of all reporting groups
163250|NCT01509040|B3|Baseline|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .
High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
163251|NCT01509040|B2|Baseline|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
163252|NCT01509040|B1|Baseline|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163253|NCT01509040|P3|Participant Flow|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .
High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
163254|NCT01509040|P2|Participant Flow|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
163343|NCT01508910|P2|Participant Flow|Active Control Arm|Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
163255|NCT01509040|P1|Participant Flow|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163256|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.
HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163257|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163258|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163259|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.
HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163260|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163261|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163262|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .
High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
163344|NCT01508910|P1|Participant Flow|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
163345|NCT01508910|O4|Outcome|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
191350|NCT01405794|O1|Outcome|Placebo|
163279|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163263|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
163264|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163265|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.
HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163266|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163267|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163268|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.
HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163269|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163270|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163346|NCT01508910|O3|Outcome|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
163347|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
163348|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
163271|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .
High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
163272|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
163273|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163274|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.
HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163275|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163276|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163277|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.
HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163278|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163349|NCT01508910|O4|Outcome|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
163350|NCT01508910|O3|Outcome|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
163280|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.
HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163281|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163282|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163283|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.
HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163284|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163285|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163286|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.
HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163351|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis.
163352|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
163353|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
163354|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
163355|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
163356|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
163357|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
165101|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
163287|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
163288|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163289|NCT01509040|O3|Outcome|High Volume Hemofiltration|"Initiate standard post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.
Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.
Initiation and maintenance of therapeutic hypothermia, target core"
163290|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.
Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.
Initiation and maintenance of therapeutic hypothermia, target core tem"
163291|NCT01509040|O1|Outcome|Control|"Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.
Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.
Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques.
Percutaneous coronary intervention performed as"
163292|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .
High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
163293|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
163294|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
165480|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
163295|NCT01509040|E3|Reported Event|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .
High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
163296|NCT01509040|E2|Reported Event|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.
Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
163297|NCT01509040|E1|Reported Event|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.
Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
163298|NCT01508936|B3|Baseline|Total|Total of all reporting groups
163299|NCT01508936|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163300|NCT01508936|B1|Baseline|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163301|NCT01508936|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163302|NCT01508936|P1|Participant Flow|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163303|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163304|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163305|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163306|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163307|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163308|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163309|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163310|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163311|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163312|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163313|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163314|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163315|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163316|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163317|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163318|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163319|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163320|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163321|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163322|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163323|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163324|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163325|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163326|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163327|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163328|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163329|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163330|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
163331|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
163359|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
163360|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
163361|NCT01508910|E4|Reported Event|Not Treated Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
163362|NCT01508910|E3|Reported Event|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
163363|NCT01508910|E2|Reported Event|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
163364|NCT01508910|E1|Reported Event|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
163365|NCT01508832|B3|Baseline|Total|Total of all reporting groups
163366|NCT01508832|B2|Baseline|Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger|Lidocaine 1% Digital Block (2cc), left finger; Bupivacaine 0.25% Digital Block (2 cc), right finger.
163367|NCT01508832|B1|Baseline|Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger|Lidocaine 1% Digital Nerve Block (2 cc) , right finger. Bupivacaine 0.25% Digital Nerve Block (2 cc), left finger
163368|NCT01508832|P2|Participant Flow|Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger|Lidocaine 1% digital nerve block (2cc), left finger; Bupivacaine 0.25% digital nerve block (2cc), right finger.
163369|NCT01508832|P1|Participant Flow|Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger|Lidocaine 1% digital nerve block (2cc), right finger; Bupivacaine 0.25% digital nerve block (2cc), left finger.
163370|NCT01508832|O2|Outcome|Bupivacaine|Bupivacaine 0.25% digital nerve block (2cc) in one finger
163371|NCT01508832|O1|Outcome|Lidocaine|Lidocaine 1% digital nerve block (2cc) in one finger
163372|NCT01508832|E2|Reported Event|Bupivacaine|Bupivacaine digital block right or left finger
163373|NCT01508832|E1|Reported Event|Lidocaine|Lidocaine digital block in right or left finger
163374|NCT01508702|B3|Baseline|Total|Total of all reporting groups
163375|NCT01508702|B2|Baseline|Placebo|
163376|NCT01508702|B1|Baseline|Lesinurad 400 mg|lesinurad 400 mg
163377|NCT01508702|P2|Participant Flow|Placebo|
163378|NCT01508702|P1|Participant Flow|Lesinurad 400 mg|lesinurad 400 mg
163379|NCT01508702|O2|Outcome|Placebo|Placebo qd
163380|NCT01508702|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg
163381|NCT01508702|E2|Reported Event|Placebo|
163382|NCT01508702|E1|Reported Event|Lesinurad 400 mg|lesinurad 400 mg
163383|NCT01508676|B3|Baseline|Total|Total of all reporting groups
163384|NCT01508676|B2|Baseline|Placebo Phase I|Placebo lotion (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.
163385|NCT01508676|B1|Baseline|Pennsaid Phase I|Pennsaid (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.
163386|NCT01508676|P2|Participant Flow|Placebo Phase I, Pennsaid Phase II|"Phase I: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily).
Washout: 1 week, applying nothing.
Phase II: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily)."
163387|NCT01508676|P1|Participant Flow|Pennsaid Phase I, Placebo Phase II|"Phase I: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily).
Washout: 1 week, applying nothing.
Phase II: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily)."
163388|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Placebo lotion in either Phase I or II were considered.
163389|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
163390|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Placebo lotion in either Phase I or II were considered.
163391|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
163392|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
163393|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
163394|NCT01508676|E2|Reported Event|Placebo|Placebo lotion (20-40 drops; 2-4 times daily for 2 weeks).
163395|NCT01508676|E1|Reported Event|Pennsaid|Pennsaid (20-40 drops; 2-4 times daily for 2 weeks).
163396|NCT01508455|B1|Baseline|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
163397|NCT01508455|P1|Participant Flow|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
163398|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
163399|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
163400|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
191351|NCT01405794|O2|Outcome|32ppm Oral Silver|
163401|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
163402|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
163403|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
163404|NCT01508455|E1|Reported Event|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
163405|NCT01508325|B3|Baseline|Total|Total of all reporting groups
165102|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
163406|NCT01508325|B2|Baseline|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163407|NCT01508325|B1|Baseline|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163408|NCT01508325|P2|Participant Flow|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163409|NCT01508325|P1|Participant Flow|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was >=90 mmHg measured every 4 weeks.
163410|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163411|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163412|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163413|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163414|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163415|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163416|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163417|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163418|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163419|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163420|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163471|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163421|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163422|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163423|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163424|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163425|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163426|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163427|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163428|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163429|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163430|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163431|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163432|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163433|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163434|NCT01508325|E2|Reported Event|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163435|NCT01508325|E1|Reported Event|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
163436|NCT01508169|B3|Baseline|Total|Total of all reporting groups
163437|NCT01508169|B2|Baseline|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163472|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163551|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
163438|NCT01508169|B1|Baseline|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163599|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163439|NCT01508169|P2|Participant Flow|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163440|NCT01508169|P1|Participant Flow|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163441|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163442|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163443|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163444|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163445|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163446|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163447|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects complited the protocolBalance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163448|NCT01508169|O1|Outcome|Foot Orthosis|Fourty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163449|NCT01508169|E2|Reported Event|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163473|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163600|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163601|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163450|NCT01508169|E1|Reported Event|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
163451|NCT01508130|B3|Baseline|Total|Total of all reporting groups
163452|NCT01508130|B2|Baseline|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163453|NCT01508130|B1|Baseline|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163454|NCT01508130|P2|Participant Flow|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163455|NCT01508130|P1|Participant Flow|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received PegIFN + RBV + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163456|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163457|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163458|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163459|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163460|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163461|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163462|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163463|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163464|NCT01508130|O1|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163465|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163466|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163467|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163468|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163469|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163470|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163593|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163474|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163475|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163476|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163477|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163478|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163479|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163480|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163481|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163482|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163483|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163484|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163485|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163486|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163487|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163488|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163489|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163490|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163491|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163492|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163493|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163594|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
165481|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
163597|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163598|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163494|NCT01508130|E2|Reported Event|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
163495|NCT01508130|E1|Reported Event|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
163496|NCT01508052|B3|Baseline|Total|Total of all reporting groups
163497|NCT01508052|B2|Baseline|Elastic Stockings|"Apply elastic stockings during the thyroidectomy
sequential compression device: applying sequential compression device during the surgery"
163498|NCT01508052|B1|Baseline|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy
elastic stockings: applying elastic stockings during the surgery"
163499|NCT01508052|P2|Participant Flow|Elastic Stockings|"Apply elastic stockings during the thyroidectomy
sequential compression device: applying sequential compression device during the surgery"
163500|NCT01508052|P1|Participant Flow|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy
elastic stockings: applying elastic stockings during the surgery"
163501|NCT01508052|O2|Outcome|Elastic Stockings|"Apply elastic stockings during the thyroidectomy
sequential compression device: applying sequential compression device during the surgery"
163502|NCT01508052|O1|Outcome|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy
elastic stockings: applying elastic stockings during the surgery"
163503|NCT01508052|E2|Reported Event|Elastic Stockings|"Apply elastic stockings during the thyroidectomy
sequential compression device: applying sequential compression device during the surgery"
163504|NCT01508052|E1|Reported Event|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy
elastic stockings: applying elastic stockings during the surgery"
163505|NCT01508013|B3|Baseline|Total|Total of all reporting groups
163506|NCT01508013|B2|Baseline|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
163507|NCT01508013|B1|Baseline|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
163508|NCT01508013|P2|Participant Flow|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
163509|NCT01508013|P1|Participant Flow|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
163510|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
163511|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
163512|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
163513|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
163514|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
163515|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
163516|NCT01508013|E2|Reported Event|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
163517|NCT01508013|E1|Reported Event|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
163518|NCT01507896|B1|Baseline|Treatment With BAX326|Recombinant Factor IX (FIX): Following a loading dose with BAX326, participants received BAX326 as a bolus infusion. The treatment regimen was determined by the intensity and duration of the hemostatic challenge and the institution's standard of care. The dose was tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries. Note: Treatment with BAX326 refers to unique participants treated with BAX326 which is less than the number of participants treated with BAX326 as unique participants could undergo more than one surgical procedure in this study. 30 unique participants were treated with BAX326 for 40 planned surgical procedures; of these, 2 unique participants were treated with BAX326 but did not undergo 2 surgical procedures (1 surgery per unique participant), therefore 28 unique participants underwent 38 surgical procedures.
163595|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
165482|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
163519|NCT01507896|P1|Participant Flow|Treatment With BAX326|Recombinant Factor IX (FIX): Following a loading dose with BAX326, participants received BAX326 as a bolus infusion. The treatment regimen was determined by the intensity and duration of the hemostatic challenge and the institution's standard of care. The dose was tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries. Note: Treatment with BAX326 refers to unique participants treated with BAX326 which is less than the number of participants treated with BAX326 as unique participants could undergo more than one surgical procedure in this study. 30 unique participants were treated with BAX326 for 40 planned surgical procedures; of these, 2 unique participants were treated with BAX326 but did not undergo 2 surgical procedures (1 surgery per unique participant), therefore 28 unique participants underwent 38 surgical procedures.
163520|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
163521|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
163522|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
163523|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
163524|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
163525|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
163526|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
163527|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
163528|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
163529|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
163530|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
163531|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
163532|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
163533|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
163534|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions
191352|NCT01405794|O1|Outcome|Placebo|
163535|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth Minor surgeries.
163536|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
163537|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
163538|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
163539|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
163540|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
163541|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
163542|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
163543|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
163544|NCT01507896|O1|Outcome|All Surgical Procedures|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
163545|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
163546|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
163547|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
163548|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient com fort. It generally referred to major orthopedic (e.g., joint replacement), major abdom inal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatom ical space. Several tooth extractions or extraction of the third molar were generally considered as major.
163549|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions
163550|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
163596|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163552|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
163553|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
163554|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
163555|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
163556|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
163557|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
163558|NCT01507896|E1|Reported Event|All Participants|All unique participants treated with BAX326 per planned surgical procedure.
163559|NCT01507831|B3|Baseline|Total|Total of all reporting groups
163560|NCT01507831|B2|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163561|NCT01507831|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163562|NCT01507831|P2|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163563|NCT01507831|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid modifying therapy (LMT) for 78 weeks.
163564|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163565|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163566|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163567|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163568|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163569|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163570|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163571|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163572|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163573|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163574|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163575|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163576|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163577|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163578|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163579|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163580|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163581|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163582|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163583|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163584|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163585|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163586|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163587|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163588|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163589|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163590|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163591|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163592|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163602|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163603|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163604|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163605|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163606|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163607|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163608|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163609|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163610|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163611|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163612|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163613|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163614|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163615|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163616|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163617|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163618|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163619|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163620|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163621|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163622|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163623|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163624|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163625|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163626|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163627|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163628|NCT01507831|E2|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
163629|NCT01507831|E1|Reported Event|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
163630|NCT01507662|B3|Baseline|Total|Total of all reporting groups
163631|NCT01507662|B2|Baseline|Control|Usual care
163632|NCT01507662|B1|Baseline|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure
Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
163633|NCT01507662|P2|Participant Flow|Control|Usual care
163634|NCT01507662|P1|Participant Flow|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure
Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
163635|NCT01507662|O2|Outcome|Control|Usual care
163636|NCT01507662|O1|Outcome|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure
Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
163637|NCT01507662|E2|Reported Event|Control|Usual care
163638|NCT01507662|E1|Reported Event|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure
Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
163639|NCT01507493|B3|Baseline|Total|Total of all reporting groups
163640|NCT01507493|B2|Baseline|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
163641|NCT01507493|B1|Baseline|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
163642|NCT01507493|P2|Participant Flow|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
163643|NCT01507493|P1|Participant Flow|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
163644|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
163645|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
163646|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
163647|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
163648|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
163649|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
163650|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
163651|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
163652|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
163653|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
163654|NCT01507493|E2|Reported Event|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
163655|NCT01507493|E1|Reported Event|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
163656|NCT01507246|B3|Baseline|Total|Total of all reporting groups
163657|NCT01507246|B2|Baseline|EXPAREL Group|Group receiving EXPAREL
163658|NCT01507246|B1|Baseline|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
163659|NCT01507246|P2|Participant Flow|EXPAREL Group|Group receiving EXPAREL
163660|NCT01507246|P1|Participant Flow|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
163661|NCT01507246|O2|Outcome|EXPAREL Group|Group receiving EXPAREL
163662|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
163663|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
163664|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
163665|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
163666|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
163667|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
163668|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
163669|NCT01507246|E2|Reported Event|EXPAREL Group|Group receiving EXPAREL
163670|NCT01507246|E1|Reported Event|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
163671|NCT01507233|B3|Baseline|Total|Total of all reporting groups
163672|NCT01507233|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163673|NCT01507233|B1|Baseline|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
163674|NCT01507233|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163675|NCT01507233|P1|Participant Flow|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
163676|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163677|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
163678|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163790|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163791|NCT01507090|E1|Reported Event|Normal Children|Otherwise healthy children 2 months to 16 years of age.
163792|NCT01507051|B5|Baseline|Total|Total of all reporting groups
163679|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
164105|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
163680|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163681|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
163682|NCT01507233|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163683|NCT01507233|E1|Reported Event|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
163684|NCT01507220|B3|Baseline|Total|Total of all reporting groups
163685|NCT01507220|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)
bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163686|NCT01507220|B1|Baseline|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
163687|NCT01507220|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)
bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163688|NCT01507220|P1|Participant Flow|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
163689|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)
bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163690|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
163691|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)
bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163692|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
163693|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)
bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163793|NCT01507051|B4|Baseline|Warfarin Alone|Days -6 to -1 (could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR
163748|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
163694|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
163695|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)
bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163696|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
163697|NCT01507220|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)
bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
All patients will be offered rescue analgesia, as needed."
163698|NCT01507220|E1|Reported Event|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)
morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
163699|NCT01507181|B3|Baseline|Total|Total of all reporting groups
163700|NCT01507181|B2|Baseline|Midazolam|single dose IV midazolam, .45mg/kg
163701|NCT01507181|B1|Baseline|Ketamine|single dose IV ketamine, .5mg/kg
163702|NCT01507181|P2|Participant Flow|Midazolam|"single dose IV midazolam, .45mg/kg
Midazolam: single dose IV midazolam, .45mg/kg infused over 40 minutes"
163703|NCT01507181|P1|Participant Flow|Ketamine|"single dose IV ketamine, .5mg/kg
Ketamine: single dose IV ketamine, .5mg/kg infused over 40 minutes"
163704|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
163705|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
163706|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
163707|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
163708|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
163709|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
163710|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
163711|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
163712|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
163713|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
163714|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
163715|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
163716|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
163717|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
163718|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
163719|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
163720|NCT01507181|E2|Reported Event|Midazolam|single dose IV midazolam, .45mg/kg
163721|NCT01507181|E1|Reported Event|Ketamine|single dose IV ketamine, .5mg/kg
163722|NCT01507155|B1|Baseline|Clinician-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.
Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
163723|NCT01507155|P2|Participant Flow|Patient-Reported Measures|Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay and used self-reported patient scales to measure clinical improvements.
163724|NCT01507155|P1|Participant Flow|Clincian-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.
Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
163725|NCT01507155|O1|Outcome|Clinician's Utilizing Assay Guided Treatment in Psychiatry|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.
Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
163726|NCT01507155|O1|Outcome|Clinician's Utilizing Assay Guided Treatment in Psychiatry|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.
Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
163727|NCT01507155|E2|Reported Event|Patient-Reported Outcomes|Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay and used self-reported patient scales to measure clinical improvements.
163728|NCT01507155|E1|Reported Event|Clinician-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.
Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
163729|NCT01507103|B4|Baseline|Total|Total of all reporting groups
163730|NCT01507103|B3|Baseline|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
163731|NCT01507103|B2|Baseline|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163732|NCT01507103|B1|Baseline|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163733|NCT01507103|P3|Participant Flow|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
163734|NCT01507103|P2|Participant Flow|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163735|NCT01507103|P1|Participant Flow|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163736|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
163737|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163738|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163739|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
163740|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163741|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163742|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
163743|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163744|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163745|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
163746|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163747|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163794|NCT01507051|B3|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
164998|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
163749|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163750|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163751|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
163752|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163753|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163754|NCT01507103|E3|Reported Event|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
163755|NCT01507103|E2|Reported Event|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163756|NCT01507103|E1|Reported Event|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
163757|NCT01507090|B1|Baseline|Normal Children|Otherwise healthy children 2 months to 16 years of age.
163758|NCT01507090|P1|Participant Flow|Normal Children|Otherwise healthy children 2 months to 16 years of age were enrolled. The 2D and 3D Mercy TAPE was developed to measure two upper arm landmarks so as to arrive at the weight estimate for a given child. The 2D Mercy TAPE requires two serial measurements with simple addition. The 3D TAPE makes both measurements simultaneously also requiring simple addition.
163759|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
163760|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
163761|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
163762|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163763|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163764|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163765|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163766|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163767|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163768|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163769|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163770|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163771|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163772|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
163773|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
163774|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
163775|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
163776|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163777|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163778|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163779|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163780|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163781|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163782|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163783|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163784|NCT01507090|O3|Outcome|Mercy Method|Study coordinators performing measurements
163785|NCT01507090|O2|Outcome|3D-TAPE|Study coordinators performing measurements
163786|NCT01507090|O1|Outcome|2D-TAPE|Study coordinators performing measurements
163787|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163788|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163789|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
163795|NCT01507051|B2|Baseline|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163796|NCT01507051|B1|Baseline|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163797|NCT01507051|P4|Participant Flow|Group D: Warfarin Alone|Days -6 to -1 (could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR
163798|NCT01507051|P3|Participant Flow|Group C: Rivaroxaban Without Any Pre-treatment With Warfarin|Days 0 to 3: 20 mg rivaroxaban once daily
163799|NCT01507051|P2|Participant Flow|Group B: Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163800|NCT01507051|P1|Participant Flow|Group A: Warfarin Followed by Rivaroxaban|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163801|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163802|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163803|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163804|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163805|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163806|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163807|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163808|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163809|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163810|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163811|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163812|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163813|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163814|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163815|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163816|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163817|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163818|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163819|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163820|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
164096|NCT01505881|P2|Participant Flow|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
163821|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163822|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163823|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163824|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163825|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163826|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163827|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163828|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163829|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163830|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163831|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163832|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163833|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163834|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163835|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163836|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163837|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163838|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163839|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163840|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163841|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163842|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163843|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163844|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163845|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163846|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163847|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
164097|NCT01505881|P1|Participant Flow|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
191353|NCT01405794|O2|Outcome|32ppm Oral Silver|
163848|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163849|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163850|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163851|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163852|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163853|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163854|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163855|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163856|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163857|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163858|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163859|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163860|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163861|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163862|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163863|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163864|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163865|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163866|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163867|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163868|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163869|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163870|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163871|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163872|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163873|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163874|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163875|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
164104|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
163876|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163877|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163878|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163879|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163880|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163881|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163882|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163883|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163884|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163885|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163886|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163887|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163888|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163889|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163890|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163891|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163892|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163893|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163894|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163895|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163896|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163897|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163898|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163899|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163900|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163901|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163902|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
164098|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
191354|NCT01405794|O1|Outcome|Placebo|
163903|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163904|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163905|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163906|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163907|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163908|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163909|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163910|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
163911|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
163912|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
163913|NCT01507051|E4|Reported Event|RG4: Warfarin Alone|All participants received warfarin in the Run-In Phase, who either received rivaroxaban or placebo afterwards, or discontinued the study. Days -6 to -1(could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR. Note: Safety Data presented here include participants listed in Groups A, B (warfarin run-in only) and D of the Participant Flow section.
163914|NCT01507051|E3|Reported Event|RG3: Rivaroxaban|All participants received rivaroxaban. Days 0 to 3: 20 mg rivaroxaban once daily. Note: Safety Data presented here include participants listed in Group C of the Participant Flow section.
163915|NCT01507051|E2|Reported Event|RG2: Warfarin Followed by Placebo|All participants received warfarin and later placebo. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group B of the Participant Flow section.
163916|NCT01507051|E1|Reported Event|RG1: Warfarin Followed by Rivaroxaban|All participants received warfarin and later rivaroxaban. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group A of the Participant Flow section.
163917|NCT01506960|B1|Baseline|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
163918|NCT01506960|P1|Participant Flow|Coronary Stenting With OCT, NIRS/IVUS|All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.
163919|NCT01506960|O2|Outcome|Deep Lipid|
163920|NCT01506960|O1|Outcome|Superficial Lipid|
163921|NCT01506960|O1|Outcome|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
163922|NCT01506960|E1|Reported Event|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
163923|NCT01506947|B1|Baseline|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163924|NCT01506947|P1|Participant Flow|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163925|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163926|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163927|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163928|NCT01506947|O2|Outcome|Month 6|
163929|NCT01506947|O1|Outcome|Baseline|
163930|NCT01506947|O2|Outcome|Month 6|
163931|NCT01506947|O1|Outcome|Baseline|
164099|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
163932|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163933|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163934|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163935|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163936|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163937|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163938|NCT01506947|E1|Reported Event|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia."
163939|NCT01506908|B3|Baseline|Total|Total of all reporting groups
163940|NCT01506908|B2|Baseline|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
163941|NCT01506908|B1|Baseline|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
163942|NCT01506908|P2|Participant Flow|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
163943|NCT01506908|P1|Participant Flow|Nicotine Lozenge 4 Milligrams (mg)|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
163944|NCT01506908|O2|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
163945|NCT01506908|O1|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
163946|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
163947|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
163948|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
163949|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
163950|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
163951|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
163952|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
163953|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
163954|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
163955|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
163956|NCT01506908|E2|Reported Event|Placebo Lozenge|Participants received a single dose of matched placebo mint lozenge, through oral route.
163957|NCT01506908|E1|Reported Event|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
163958|NCT01506882|B3|Baseline|Total Title|
163959|NCT01506882|B2|Baseline|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
Frequency: Twice daily"
163960|NCT01506882|B1|Baseline|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
Frequency: Twice daily"
163961|NCT01506882|P2|Participant Flow|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
Frequency: Twice daily"
163962|NCT01506882|P1|Participant Flow|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
Frequency: Twice daily"
163963|NCT01506882|O1|Outcome|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
Frequency: Twice daily"
164100|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
163964|NCT01506882|O1|Outcome|Full Analysis Set (LEV 3000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.
Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
Frequency: Twice daily"
163965|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.
Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
Frequency: Twice daily"
163966|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.
Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
Frequency: Twice daily"
163967|NCT01506882|O1|Outcome|Full Analysis Set (LEV 3000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.
Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
Frequency: Twice daily"
163968|NCT01506882|O1|Outcome|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
Frequency: Twice daily"
163969|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.
Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
Frequency: Twice daily"
163970|NCT01506882|O1|Outcome|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
Frequency: Twice daily"
163971|NCT01506882|E2|Reported Event|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
Frequency: Twice daily"
163972|NCT01506882|E1|Reported Event|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
Frequency: Twice daily"
163973|NCT01506726|B3|Baseline|Total|Total of all reporting groups
163974|NCT01506726|B2|Baseline|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163975|NCT01506726|B1|Baseline|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
163976|NCT01506726|P2|Participant Flow|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163977|NCT01506726|P1|Participant Flow|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
163978|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163979|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
164023|NCT01506596|E1|Reported Event|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
163980|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163981|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
163982|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163983|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
163984|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163985|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
163986|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163987|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
163988|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163989|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
163990|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163991|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
163992|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163993|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
164101|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
164999|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
163994|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163995|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
163996|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163997|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
163998|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
163999|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
164000|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
164001|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
164002|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
164003|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
164004|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
164005|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
164006|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
164007|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
164102|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator.
165483|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
164008|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
164009|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
164010|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
164011|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
164012|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
164013|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
164014|NCT01506726|E2|Reported Event|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
164015|NCT01506726|E1|Reported Event|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.
Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
164016|NCT01506596|B1|Baseline|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
164017|NCT01506596|P1|Participant Flow|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
164018|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
164019|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
164020|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
164021|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
164022|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
165000|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
164024|NCT01506362|B1|Baseline|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.
BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
164025|NCT01506362|P1|Participant Flow|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.
BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
164026|NCT01506362|O1|Outcome|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.
BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
164027|NCT01506362|E1|Reported Event|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.
BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
164028|NCT01506323|B3|Baseline|Total|Total of all reporting groups
164029|NCT01506323|B2|Baseline|Present Centered Therapy (PCT)|Present Centered Individual Therapy (PCT): The PCT is a form of individual therapy that is problem-oriented to improve current coping. It avoids details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention control arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
164030|NCT01506323|B1|Baseline|Mantram Repetition Program (MRP)|The Mantram Repetition Program (MRP) teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164031|NCT01506323|P2|Participant Flow|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically avoids actual details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
164032|NCT01506323|P1|Participant Flow|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164033|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCIT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164034|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164035|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164103|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
165001|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
164036|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164037|NCT01506323|O2|Outcome|Arm 2: Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164038|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164039|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164040|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164041|NCT01506323|O2|Outcome|Arm 2: Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164042|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164043|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164044|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164045|NCT01506323|O2|Outcome|Present Centered Therapy|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164074|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
165002|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
164046|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164047|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)`|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164048|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164049|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164050|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164051|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164052|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164053|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164054|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164055|NCT01506323|E2|Reported Event|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
164075|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164463|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164056|NCT01506323|E1|Reported Event|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
164057|NCT01506193|B4|Baseline|Total|Total of all reporting groups
164058|NCT01506193|B3|Baseline|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164059|NCT01506193|B2|Baseline|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164060|NCT01506193|B1|Baseline|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164061|NCT01506193|P3|Participant Flow|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164062|NCT01506193|P2|Participant Flow|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164063|NCT01506193|P1|Participant Flow|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164064|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164065|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164066|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164067|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164068|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164069|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164070|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164071|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164072|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164073|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164464|NCT01502371|E5|Reported Event|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164076|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164077|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164078|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164079|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164080|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164081|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164082|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164083|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164084|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164085|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164086|NCT01506193|O2|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164087|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164088|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164089|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164090|NCT01506193|E3|Reported Event|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164091|NCT01506193|E2|Reported Event|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164092|NCT01506193|E1|Reported Event|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
164093|NCT01505881|B3|Baseline|Total|Total of all reporting groups
164094|NCT01505881|B2|Baseline|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
164095|NCT01505881|B1|Baseline|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
164106|NCT01505881|E2|Reported Event|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
164107|NCT01505881|E1|Reported Event|Dabigatran Etexilate|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
164108|NCT01505764|B3|Baseline|Total|Total of all reporting groups
164109|NCT01505764|B2|Baseline|Arm 2|"Placebo
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
164110|NCT01505764|B1|Baseline|Arm 1|"Anamorelin HCl
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
164111|NCT01505764|P2|Participant Flow|Arm 2|"Placebo
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
164112|NCT01505764|P1|Participant Flow|Arm 1|"Anamorelin HCl
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
164113|NCT01505764|O2|Outcome|Arm 2|"Placebo
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
164114|NCT01505764|O1|Outcome|Arm 1|"Anamorelin HCl
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
164115|NCT01505764|E2|Reported Event|Arm 2|"Placebo
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
164116|NCT01505764|E1|Reported Event|Arm 1|"Anamorelin HCl
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
164117|NCT01505647|B3|Baseline|Total|Total of all reporting groups
164118|NCT01505647|B2|Baseline|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
164119|NCT01505647|B1|Baseline|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
164120|NCT01505647|P2|Participant Flow|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
164121|NCT01505647|P1|Participant Flow|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live Alternative Manufacturing Process (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
164122|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
164123|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
164124|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
164125|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
164126|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
164127|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
164128|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
164129|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
164130|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
164131|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
164132|NCT01505647|E2|Reported Event|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
164133|NCT01505647|E1|Reported Event|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
164134|NCT01505608|B3|Baseline|Total|Total of all reporting groups
164135|NCT01505608|B2|Baseline|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164136|NCT01505608|B1|Baseline|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164137|NCT01505608|P2|Participant Flow|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
165003|NCT01499654|E1|Reported Event|Study Group|Entire cohort for the study
164185|NCT01505374|O2|Outcome|Control Technique: Femoral Nerve Block|Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
164138|NCT01505608|P1|Participant Flow|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
During Phase 2- Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164139|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164140|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164141|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164142|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164143|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164144|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164145|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164146|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164147|NCT01505608|O2|Outcome|Phase I Patients + Phase II Assigned Arm B- Tmz +I+ TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164178|NCT01505387|E1|Reported Event|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)
Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
164179|NCT01505374|B1|Baseline|All Study Participants|
164148|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164149|NCT01505608|O2|Outcome|Arm A- TMZ + Irinotecan Only|Did not receive TPI 287
164150|NCT01505608|O1|Outcome|TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164151|NCT01505608|E2|Reported Event|Phase II Arm A- Subjects That Did Not Receive TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide
Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164152|NCT01505608|E1|Reported Event|TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
164153|NCT01505465|B3|Baseline|Total|Total of all reporting groups
164154|NCT01505465|B2|Baseline|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
164155|NCT01505465|B1|Baseline|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
164156|NCT01505465|P2|Participant Flow|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
164157|NCT01505465|P1|Participant Flow|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
164158|NCT01505465|O2|Outcome|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
164159|NCT01505465|O1|Outcome|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
164160|NCT01505465|O2|Outcome|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
164161|NCT01505465|O1|Outcome|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
164162|NCT01505465|O2|Outcome|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
164163|NCT01505465|O1|Outcome|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
164164|NCT01505465|O2|Outcome|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
164165|NCT01505465|O1|Outcome|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
164166|NCT01505465|O2|Outcome|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
164167|NCT01505465|O1|Outcome|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
164168|NCT01505465|E2|Reported Event|Control: Placebo|Placebo: 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
164169|NCT01505465|E1|Reported Event|Study: Melatonin|Melatonin: 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
164170|NCT01505387|B3|Baseline|Total|Total of all reporting groups
164171|NCT01505387|B2|Baseline|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
164172|NCT01505387|B1|Baseline|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)
Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
164173|NCT01505387|P2|Participant Flow|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
164174|NCT01505387|P1|Participant Flow|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)
Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
164175|NCT01505387|O2|Outcome|Litramine|"Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal)
Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
164176|NCT01505387|O1|Outcome|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)
Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
164177|NCT01505387|E2|Reported Event|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
164180|NCT01505374|P2|Participant Flow|Study Technique Left Leg, Control Technique Right Leg|
164186|NCT01505374|O1|Outcome|Study Technique: Saphenous Nerve Block|Study Technique: One leg will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
164187|NCT01505374|O2|Outcome|Control Technique: Femoral Nerve Block|Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
164188|NCT01505374|O1|Outcome|Study Technique: Saphenous Nerve Block|Study Technique: One leg will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
164189|NCT01505374|O1|Outcome|All Patients|
164190|NCT01505374|O2|Outcome|Control Technique: Femoral Nerve Block|Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
164191|NCT01505374|O1|Outcome|Study Technique: Saphenous Nerve Block|Study Technique: One leg will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
164192|NCT01505374|E2|Reported Event|Control Technique: Femoral Nerve Block|
164193|NCT01505374|E1|Reported Event|Study Technique: Saphenous Nerve Block|
164194|NCT01505114|B5|Baseline|Total|Total of all reporting groups
164195|NCT01505114|B4|Baseline|Arm 4|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Maraviroc placebo: Once daily from Week 0 through Week 48"
164196|NCT01505114|B3|Baseline|Arm 3|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48"
164197|NCT01505114|B2|Baseline|Arm 2|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
164198|NCT01505114|B1|Baseline|Arm 1|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
164199|NCT01505114|P4|Participant Flow|TDF + FTC|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Maraviroc placebo: Once daily from Week 0 through Week 48"
164200|NCT01505114|P3|Participant Flow|MVC + TDF|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48"
164201|NCT01505114|P2|Participant Flow|MVC + FTC|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
164202|NCT01505114|P1|Participant Flow|MVC Only|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
164203|NCT01505114|O4|Outcome|Arm 4|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Maraviroc placebo: Once daily from Week 0 through Week 48"
164204|NCT01505114|O3|Outcome|Arm 3|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48"
164205|NCT01505114|O2|Outcome|Arm 2|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
164206|NCT01505114|O1|Outcome|Arm 1|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
164207|NCT01505114|E4|Reported Event|Arm 4|"MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Maraviroc placebo: Once daily from Week 0 through Week 48"
164264|NCT01504854|B2|Baseline|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.
Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
164208|NCT01505114|E3|Reported Event|Arm 3|"MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48"
165103|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
164209|NCT01505114|E2|Reported Event|Arm 2|"MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
164210|NCT01505114|E1|Reported Event|Arm 1|"MVC 300 mg plus FTC placebo and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48"
164211|NCT01504997|B1|Baseline|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy
Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
164212|NCT01504997|P1|Participant Flow|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy
Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
164213|NCT01504997|O1|Outcome|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy
Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
164214|NCT01504997|E1|Reported Event|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy
Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
164215|NCT01504971|B1|Baseline|Gastroesophageal Reflux Disease (GERD)|"symptom questionaire: GerdQ questionaire
pH monitoring: 24-hour pH monitoring
Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI
rabeprazole: 10mg, bid, p.o."
164216|NCT01504971|P1|Participant Flow|Gastroesophageal Reflux Disease (GERD)|"symptom questionaire: GerdQ questionaire
pH monitoring: 24-hour pH monitoring
Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI
rabeprazole: 10mg, bid, p.o."
164217|NCT01504971|O3|Outcome|Participants Same to Previous Arm|Diagnostic capabilities of GerdQ in the diagnosis of GERD
164218|NCT01504971|O2|Outcome|Participants Same to arm1|Diagnostic capabilities of Autofluorescence Imaging on Gastroesophageal Reflux Disease
164219|NCT01504971|O1|Outcome|Participants|Diagnostic capabilities of White-light Imaging on Gastroesophageal Reflux Disease
164220|NCT01504971|E3|Reported Event|Participants Same to Previous Arm|Diagnostic capabilities of GerdQ in the diagnosis of GERD
164221|NCT01504971|E2|Reported Event|Participants Same to arm1|Diagnostic capabilities of AFI in the diagnosis of GERD
164222|NCT01504971|E1|Reported Event|Participants|Diagnostic capabilities of WLI in the diagnosis of GERD
164223|NCT01504958|B4|Baseline|Total|Total of all reporting groups
164224|NCT01504958|B3|Baseline|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
164225|NCT01504958|B2|Baseline|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164226|NCT01504958|B1|Baseline|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164227|NCT01504958|P3|Participant Flow|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
164236|NCT01504958|O3|Outcome|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
191355|NCT01405794|E2|Reported Event|Silver Biotics 32 Ppm Diluent|
164306|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164228|NCT01504958|P2|Participant Flow|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164229|NCT01504958|P1|Participant Flow|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164230|NCT01504958|O3|Outcome|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
164231|NCT01504958|O2|Outcome|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164232|NCT01504958|O1|Outcome|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164233|NCT01504958|O3|Outcome|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
164234|NCT01504958|O2|Outcome|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164235|NCT01504958|O1|Outcome|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164262|NCT01504867|E1|Reported Event|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
164237|NCT01504958|O2|Outcome|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164238|NCT01504958|O1|Outcome|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164239|NCT01504958|E3|Reported Event|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
164240|NCT01504958|E2|Reported Event|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164241|NCT01504958|E1|Reported Event|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
Sham participants will receive the same study procedures as patients receiving active rTMS.
NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
A particular cognitive exercise will start 200msec after the termination of each TMS train.
Sham participants receive real cognitive training that follows the same procedures as the active group."
164242|NCT01504867|B3|Baseline|Total|Total of all reporting groups
164243|NCT01504867|B2|Baseline|Placebo|This group received matching lactose powder filled capsules on days 1-7.
164244|NCT01504867|B1|Baseline|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
164245|NCT01504867|P2|Participant Flow|Placebo|This group received matching lactose powder filled capsules on days 1-7.
164246|NCT01504867|P1|Participant Flow|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
164247|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
164248|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
164249|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
164250|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
164251|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
164252|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
164253|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
164254|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
164255|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
164256|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
164257|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
164258|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
164259|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
164260|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
164261|NCT01504867|E2|Reported Event|Placebo|This group received matching lactose powder filled capsules on days 1-7.
164265|NCT01504854|B1|Baseline|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.
Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
164266|NCT01504854|P2|Participant Flow|Placebo|"Subjects will receive a matching placebo to be taken with or without food.
Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
164267|NCT01504854|P1|Participant Flow|Resveratrol|"Subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.
Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
164268|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.
Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
164269|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.
Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
164270|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.
Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
164271|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.
Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
164272|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.
Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
164273|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.
Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
164274|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.
Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
164275|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.
Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
164276|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.
Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
164277|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.
Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
164278|NCT01504854|E2|Reported Event|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.
Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
164279|NCT01504854|E1|Reported Event|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.
Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
164280|NCT01503749|B4|Baseline|Total|Total of all reporting groups
164281|NCT01503749|B3|Baseline|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells
. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
164282|NCT01503749|B2|Baseline|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.
G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
164283|NCT01503749|B1|Baseline|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
164284|NCT01503749|P3|Participant Flow|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells
. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
165484|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
164285|NCT01503749|P2|Participant Flow|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.
G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
164286|NCT01503749|P1|Participant Flow|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
164287|NCT01503749|O3|Outcome|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells
. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
164288|NCT01503749|O2|Outcome|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.
G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
164289|NCT01503749|O1|Outcome|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
164290|NCT01503749|O3|Outcome|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells
. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
164291|NCT01503749|O2|Outcome|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.
G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
164292|NCT01503749|O1|Outcome|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
164293|NCT01503749|E3|Reported Event|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells
. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
164294|NCT01503749|E2|Reported Event|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.
G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
164295|NCT01503749|E1|Reported Event|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
164296|NCT01503021|B3|Baseline|Total|Total of all reporting groups
164297|NCT01503021|B2|Baseline|Placebo/SFP|Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
164298|NCT01503021|B1|Baseline|SFP/Placebo|Soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
164299|NCT01503021|P2|Participant Flow|Placebo/SFP|Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
164300|NCT01503021|P1|Participant Flow|SFP/Placebo|Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
164301|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164302|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
164303|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164304|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164305|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
165093|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole (EOT)|EOT - within 24 hours after last dose of study drug
164307|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164308|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164309|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164310|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164311|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164312|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164313|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164314|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164315|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164316|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164317|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164318|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks
SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
164319|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164320|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
164321|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164322|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164323|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
164324|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164325|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164326|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
164465|NCT01502371|E4|Reported Event|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
164327|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164328|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164329|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
164330|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164331|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164332|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
164333|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164334|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164335|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
164336|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164337|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164338|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
164339|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164340|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164341|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
164342|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164343|NCT01503021|E3|Reported Event|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164344|NCT01503021|E2|Reported Event|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
164345|NCT01503021|E1|Reported Event|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
164346|NCT01502787|B1|Baseline|All Participants|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period , there will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
164347|NCT01502787|P2|Participant Flow|Nebivolol First, Then Metoprolol|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
164348|NCT01502787|P1|Participant Flow|Metoprolol First Then Nebivolol|"The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
Metoprolol succinate: The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued."
164349|NCT01502787|O2|Outcome|Second Intervention Nebivolol: 24 Weeks|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks.
164350|NCT01502787|O1|Outcome|First Intervention Metoprolol: 12 Weeks|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
164403|NCT01502423|B1|Baseline|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
164351|NCT01502787|E2|Reported Event|Nebivolol 21 Subjects|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
164352|NCT01502787|E1|Reported Event|Metoprolol 21 Subjects|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
164353|NCT01502761|B5|Baseline|Total|Total of all reporting groups
164354|NCT01502761|B4|Baseline|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial"
164355|NCT01502761|B3|Baseline|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial"
164356|NCT01502761|B2|Baseline|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial"
164357|NCT01502761|B1|Baseline|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial"
164358|NCT01502761|P4|Participant Flow|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial"
164359|NCT01502761|P3|Participant Flow|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial"
164360|NCT01502761|P2|Participant Flow|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial"
164361|NCT01502761|P1|Participant Flow|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial"
164362|NCT01502761|O4|Outcome|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial"
164363|NCT01502761|O3|Outcome|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial"
164364|NCT01502761|O2|Outcome|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial"
164365|NCT01502761|O1|Outcome|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial"
164366|NCT01502761|O4|Outcome|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial"
164367|NCT01502761|O3|Outcome|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial"
164368|NCT01502761|O2|Outcome|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial"
164369|NCT01502761|O1|Outcome|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial"
164370|NCT01502761|E4|Reported Event|Regional/ Distal (50/50%) Magnesium 1.5g|"Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial"
164371|NCT01502761|E3|Reported Event|Regional/ Distal (75/25%) Magnesium 1.5g|"Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial"
164372|NCT01502761|E2|Reported Event|Regional Intra-arterial Magnesium 1.5g|"Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial"
164373|NCT01502761|E1|Reported Event|Regional Intra-arterial Magnesium 0.75g|"Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial"
164374|NCT01502709|B3|Baseline|Total|Total of all reporting groups
164375|NCT01502709|B2|Baseline|Placebo Arm|0 participants received placebo
164376|NCT01502709|B1|Baseline|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
164377|NCT01502709|P2|Participant Flow|Placebo Arm|0 participants received placebo
164378|NCT01502709|P1|Participant Flow|Caloric Vestibular Neurostimulation|1 treatment of caloric vestibular neurostimulation for 7.5 minutes in the right ear
164379|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
164380|NCT01502709|O1|Outcome|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
164381|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
164382|NCT01502709|O1|Outcome|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
164383|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
164384|NCT01502709|O1|Outcome|Neurostimulator|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
164385|NCT01502709|E2|Reported Event|Placebo Arm|0 participants received placebo
164386|NCT01502709|E1|Reported Event|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
164387|NCT01502644|B4|Baseline|Total|Total of all reporting groups
164388|NCT01502644|B3|Baseline|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164389|NCT01502644|B2|Baseline|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164390|NCT01502644|B1|Baseline|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164391|NCT01502644|P4|Participant Flow|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164392|NCT01502644|P3|Participant Flow|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164393|NCT01502644|P2|Participant Flow|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164394|NCT01502644|P1|Participant Flow|Enrolled at Visit 1|All participants who satisfied pre-screening requirements and were enrolled at Visit 1.
164395|NCT01502644|O3|Outcome|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164396|NCT01502644|O2|Outcome|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164397|NCT01502644|O1|Outcome|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164398|NCT01502644|E3|Reported Event|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164399|NCT01502644|E2|Reported Event|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164400|NCT01502644|E1|Reported Event|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
164401|NCT01502423|B3|Baseline|Total|Total of all reporting groups
164402|NCT01502423|B2|Baseline|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
164462|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164404|NCT01502423|P2|Participant Flow|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
164405|NCT01502423|P1|Participant Flow|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
164406|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
164407|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
164408|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
164409|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
164410|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
164411|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
164412|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
164413|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
164414|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
164415|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
164416|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
164417|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
164418|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
164419|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
164420|NCT01502423|E2|Reported Event|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
164421|NCT01502423|E1|Reported Event|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
164422|NCT01502410|B5|Baseline|Total|Total of all reporting groups
164423|NCT01502410|B4|Baseline|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164424|NCT01502410|B3|Baseline|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164425|NCT01502410|B2|Baseline|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164426|NCT01502410|B1|Baseline|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164427|NCT01502410|P4|Participant Flow|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164428|NCT01502410|P3|Participant Flow|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164429|NCT01502410|P2|Participant Flow|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164430|NCT01502410|P1|Participant Flow|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164466|NCT01502371|E3|Reported Event|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
165104|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
164431|NCT01502410|O4|Outcome|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164432|NCT01502410|O3|Outcome|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164433|NCT01502410|O2|Outcome|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164434|NCT01502410|O1|Outcome|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
pharmacological study: Optional correlative studies
laboratory biomarker analysis: Optional correlative studies"
164435|NCT01502410|E2|Reported Event|Group 2 Relapsed/Refractory Wilms Tumor|Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
164436|NCT01502410|E1|Reported Event|Group 1 Relapsed/Refractory Rhabdomyosarcoma|Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
164437|NCT01502371|B6|Baseline|Total|Total of all reporting groups
164438|NCT01502371|B5|Baseline|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164439|NCT01502371|B4|Baseline|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
164440|NCT01502371|B3|Baseline|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164441|NCT01502371|B2|Baseline|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164442|NCT01502371|B1|Baseline|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164443|NCT01502371|P5|Participant Flow|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164444|NCT01502371|P4|Participant Flow|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
164445|NCT01502371|P3|Participant Flow|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164446|NCT01502371|P2|Participant Flow|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164447|NCT01502371|P1|Participant Flow|MF MDI 50 mcg BID|Participants receive mometasone furoate (MF) metered dose inhaler (MDI) 25 mcg x 2 inhalations (50 mcg total dose) twice daily (BID) PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.
164448|NCT01502371|O2|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
164449|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164450|NCT01502371|O5|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
164451|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164452|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164453|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164454|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164455|NCT01502371|O5|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
164456|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164457|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164458|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164459|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164460|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164461|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
165094|NCT01499290|O6|Outcome|Meropenem (LFU)|LFU - 42 to 49 days after start of study drug
164467|NCT01502371|E2|Reported Event|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164468|NCT01502371|E1|Reported Event|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
164469|NCT01502332|B3|Baseline|Total|Total of all reporting groups
164470|NCT01502332|B2|Baseline|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164471|NCT01502332|B1|Baseline|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164472|NCT01502332|P2|Participant Flow|Moderate Alveolar Recruitment|Moderate alveolar recruitment ARM: recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164473|NCT01502332|P1|Participant Flow|Intensive Alveolar Recruitment|Intensive Alveolar Recruitment ARM: recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164474|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164475|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164476|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164477|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164478|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164479|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164480|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164481|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164482|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164483|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164484|NCT01502332|E2|Reported Event|Moderate Alveolar Recruitment ARM|Mechanical ventilation strategy: Moderate alveolar recruitment ARM: recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164485|NCT01502332|E1|Reported Event|Intensive Alveolar Recruitment ARM|Mechanical ventilation strategy: Intensive Alveolar Recruitment ARM: recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
164486|NCT01502228|B1|Baseline|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.
62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
164487|NCT01502228|P1|Participant Flow|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.
62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
164514|NCT01501110|O1|Outcome|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.
N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
164515|NCT01501110|E2|Reported Event|no Intervention|No intervention / usual care
165004|NCT01499576|B1|Baseline|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
165006|NCT01499576|O1|Outcome|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
164488|NCT01502228|O1|Outcome|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.
62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
164489|NCT01502228|O1|Outcome|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.
62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
164490|NCT01502228|E1|Reported Event|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.
62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
164491|NCT01502033|B1|Baseline|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
Transcranial Magnetic Stimulation"
164492|NCT01502033|P1|Participant Flow|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
Transcranial Magnetic Stimulation"
164493|NCT01502033|O1|Outcome|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
Transcranial Magnetic Stimulation: 30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment"
164494|NCT01502033|O1|Outcome|Open Label Active Treatment|All participants had unblended treatment
164495|NCT01502033|O1|Outcome|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
Transcranial Magnetic Stimulation"
164496|NCT01502033|E1|Reported Event|Open Label Active Treatment|All participants had unblinded treatment
164497|NCT01501162|B3|Baseline|Total|Total of all reporting groups
164498|NCT01501162|B2|Baseline|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
164499|NCT01501162|B1|Baseline|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
164500|NCT01501162|P2|Participant Flow|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
164501|NCT01501162|P1|Participant Flow|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
164502|NCT01501162|O2|Outcome|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
164503|NCT01501162|O1|Outcome|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
164504|NCT01501162|O2|Outcome|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
164505|NCT01501162|O1|Outcome|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
164506|NCT01501162|E2|Reported Event|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
164507|NCT01501162|E1|Reported Event|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
164508|NCT01501110|B3|Baseline|Total|Total of all reporting groups
164509|NCT01501110|B2|Baseline|no Intervention|No intervention / usual care
164510|NCT01501110|B1|Baseline|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.
N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
164511|NCT01501110|P2|Participant Flow|no Intervention|No intervention / usual care
164512|NCT01501110|P1|Participant Flow|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.
N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
164513|NCT01501110|O2|Outcome|no Intervention|No intervention / usual care
164516|NCT01501110|E1|Reported Event|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.
N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
164517|NCT01500772|B1|Baseline|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
164518|NCT01500772|P1|Participant Flow|Alisporivir|Alisporivir (ALV) 400 mg twice daily (BID), with peginterferon alfa-2a (PEG) and ribavirin (RBV) for 48 weeks.
164519|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
164520|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
164521|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
164522|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
164523|NCT01500772|E1|Reported Event|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
164524|NCT01500746|B3|Baseline|Total|Total of all reporting groups
164525|NCT01500746|B2|Baseline|Moist Dressings|"This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments)."
164526|NCT01500746|B1|Baseline|Lavage Arm|"This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
Pulse lavage treatment: A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments)."
164527|NCT01500746|P2|Participant Flow|Moist Dressings|This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
164528|NCT01500746|P1|Participant Flow|Lavage Arm|This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
164529|NCT01500746|O2|Outcome|Moist Dressings|This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
164530|NCT01500746|O1|Outcome|Lavage Arm|This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
164531|NCT01500746|E2|Reported Event|Moist Dressings|"This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments)."
164532|NCT01500746|E1|Reported Event|Lavage Arm|"This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
Pulse lavage treatment: A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments)."
164533|NCT01500720|B3|Baseline|Total|Total of all reporting groups
164534|NCT01500720|B2|Baseline|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164535|NCT01500720|B1|Baseline|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164536|NCT01500720|P2|Participant Flow|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164537|NCT01500720|P1|Participant Flow|Cabazitaxel|Cabazitaxel (XRP6258) 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164538|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164539|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164540|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164541|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164542|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164543|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164544|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164545|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164546|NCT01500720|E2|Reported Event|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164547|NCT01500720|E1|Reported Event|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
164548|NCT01500694|B3|Baseline|Total|Total of all reporting groups
164549|NCT01500694|B2|Baseline|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
191356|NCT01405794|E1|Reported Event|ASAP 32 Ppm Solution Experimental|
164550|NCT01500694|B1|Baseline|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164551|NCT01500694|P2|Participant Flow|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164552|NCT01500694|P1|Participant Flow|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 milligram [mg] or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164553|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164554|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164555|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164556|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164557|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164558|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164559|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164560|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164561|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164562|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164563|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164564|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164565|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164566|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164567|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164568|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164569|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164570|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164571|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164572|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164573|NCT01500694|E2|Reported Event|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164574|NCT01500694|E1|Reported Event|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
164575|NCT01500629|B3|Baseline|Total|Total of all reporting groups
164695|NCT01500382|B1|Baseline|Vibegron 100 mg + Tolterodine 4 mg → Placebo|During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
164576|NCT01500629|B2|Baseline|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164577|NCT01500629|B1|Baseline|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164578|NCT01500629|P2|Participant Flow|Placebo Then C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164579|NCT01500629|P1|Participant Flow|C-1266-7 Then Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164580|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164581|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164582|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164583|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164584|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164585|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164586|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164587|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164588|NCT01500629|O2|Outcome|C-1266-6 Then C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164589|NCT01500629|O1|Outcome|C-1266-7 Then C-1266-6|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164590|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164591|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164592|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164593|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164594|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164595|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164596|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164597|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164598|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164599|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
191357|NCT01405768|B3|Baseline|Total|Total of all reporting groups
164600|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164601|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164602|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164603|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164604|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164605|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164606|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164607|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164608|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164609|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164610|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164611|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164882|NCT01499862|O2|Outcome|Patient 2|Five Times Sit to Stand Test (seconds)
164612|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164613|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164614|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164615|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164616|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164617|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164618|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164619|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164620|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164621|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164622|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164623|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164883|NCT01499862|O1|Outcome|Patient 1|Five Times Sit to Stand Test (seconds)
164624|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164625|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164626|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164627|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164628|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164629|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164630|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164631|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164632|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164633|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164634|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164635|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164884|NCT01499862|O3|Outcome|Patient 3|Timed Up and Go Test (seconds)
164636|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164637|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164638|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164639|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164640|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164641|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164642|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164643|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164644|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164645|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164646|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164647|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164648|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164649|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164650|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164651|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164652|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164653|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164654|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo).. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo).: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164655|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164656|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6, (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164657|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164658|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164885|NCT01499862|O2|Outcome|Patient 2|Timed Up and Go Test (seconds)
164886|NCT01499862|O1|Outcome|Patient 1|Timed Up and Go Test (seconds)
164887|NCT01499862|O3|Outcome|Patient 3|Six Minute Walk Test (meters)
164888|NCT01499862|O2|Outcome|Patient 2|Six Minute Walk Test (meters)
164659|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
164660|NCT01500629|E2|Reported Event|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164661|NCT01500629|E1|Reported Event|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.
C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
164662|NCT01500434|B1|Baseline|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164663|NCT01500434|P1|Participant Flow|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164664|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164665|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164666|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164667|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164668|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164669|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164670|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164671|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164672|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164673|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164674|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164675|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164676|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164677|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164678|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164679|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164680|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164681|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164682|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164683|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164684|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164685|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164686|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164687|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164688|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164689|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164690|NCT01500434|E1|Reported Event|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
164691|NCT01500382|B5|Baseline|Total|Total of all reporting groups
164692|NCT01500382|B4|Baseline|Placebo → Vibegron 50 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
164693|NCT01500382|B3|Baseline|Placebo → Tolterodine 4 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
164694|NCT01500382|B2|Baseline|Placebo → Vibegron 100 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
164889|NCT01499862|O1|Outcome|Patient 1|Six Minute Walk Test (meters)
164890|NCT01499862|E1|Reported Event|Tibion Arm Baseline Assessments|Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
164696|NCT01500382|P4|Participant Flow|Placebo → Vibegron 50 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
164697|NCT01500382|P3|Participant Flow|Placebo → Tolterodine 4 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
164698|NCT01500382|P2|Participant Flow|Placebo → Vibegron 100 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
164699|NCT01500382|P1|Participant Flow|Vibegron 100 mg + Tolterodine 4 mg → Placebo|During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
164700|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
164701|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
164702|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
164703|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
164704|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
164705|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
164706|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
164707|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
164708|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
164709|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
164710|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
164711|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
164712|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
164713|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
164714|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
164715|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
164716|NCT01500382|E4|Reported Event|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
164717|NCT01500382|E3|Reported Event|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
164718|NCT01500382|E2|Reported Event|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
164719|NCT01500382|E1|Reported Event|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
164720|NCT01500317|B4|Baseline|Total|Total of all reporting groups
164721|NCT01500317|B3|Baseline|Placebo|Placebo tid
164722|NCT01500317|B2|Baseline|Oxycodone|5 mg oxycodone tid
164723|NCT01500317|B1|Baseline|Tapentadol|75 mg tapentadol tid
164724|NCT01500317|P3|Participant Flow|Placebo|Placebo tid
164725|NCT01500317|P2|Participant Flow|Oxycodone|5 mg oxycodone tid
164726|NCT01500317|P1|Participant Flow|Tapentadol|75 mg tapentadol tid
164727|NCT01500317|O3|Outcome|Placebo|Placebo tid
164728|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
164729|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
164730|NCT01500317|O3|Outcome|Placebo|Placebo tid
164731|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
164732|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
164733|NCT01500317|O3|Outcome|Placebo|Placebo tid
164734|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
164735|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
164736|NCT01500317|O3|Outcome|Placebo|Placebo tid
164737|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
164738|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
164739|NCT01500317|O3|Outcome|Placebo|Placebo tid
164740|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
164741|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
164742|NCT01500317|E3|Reported Event|Placebo|Placebo tid
164743|NCT01500317|E2|Reported Event|Oxycodone|5 mg oxycodone tid
164744|NCT01500317|E1|Reported Event|Tapentadol|75 mg tapentadol tid
164745|NCT01500278|B3|Baseline|Total Title|
164891|NCT01499849|B3|Baseline|Total|Total of all reporting groups
165005|NCT01499576|P1|Participant Flow|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
165095|NCT01499290|O5|Outcome|CAZ-AVI + Metronidazole (LFU)|LFU - 42 to 49 days after start of study drug
164746|NCT01500278|B2|Baseline|ADA+MTX (RTG)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.
Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164747|NCT01500278|B1|Baseline|CZP+MTX (RTG)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.
Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164748|NCT01500278|P2|Participant Flow|ADA+MTX (RTG)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.
Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164749|NCT01500278|P1|Participant Flow|CZP+MTX (RTG)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.
Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164750|NCT01500278|O2|Outcome|ADA+MTX (Week 12 Responder Set)|"ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164751|NCT01500278|O1|Outcome|CZP+MTX (Week 12 Responder Set)|"CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164752|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.
Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164753|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.
Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164754|NCT01500278|O2|Outcome|ADA+MTX (Week 12 Responder Set)|"ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164755|NCT01500278|O1|Outcome|CZP+MTX (Week 12 Responder Set)|"CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164972|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
164756|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.
Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164757|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.
Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164758|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.
Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164759|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.
Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164760|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.
Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164761|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.
Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164762|NCT01500278|O2|Outcome|ADA+MTX (Week 12 Responder Set)|"ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164763|NCT01500278|O1|Outcome|CZP+MTX (Week 12 Responder Set)|"CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164764|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.
Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164973|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
164765|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.
Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164766|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.
Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164767|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.
Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.
Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.
All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
164768|NCT01500278|E2|Reported Event|ADA+MTX (SS)|All subjects who received at least 1 dose of Adalimumab (ADA). All adverse events that occurred when the subject was receiving ADA treatment are summarized in this group.
164769|NCT01500278|E1|Reported Event|CZP+MTX (SS)|All subjects who received at least 1 dose of Certolizumab pegol (CZP). All adverse events that occurred when the subject was receiving CZP treatment are summarized in this group.
164770|NCT01500252|B3|Baseline|Total|Total of all reporting groups
164771|NCT01500252|B2|Baseline|Patellar Retention|Subjects retained their native patella.
164772|NCT01500252|B1|Baseline|Patellar Resurfacing|Subjects received patellar resurfacing.
164773|NCT01500252|P2|Participant Flow|Patellar Retention|Subjects retained their native patella.
164774|NCT01500252|P1|Participant Flow|Patellar Resurfacing|Subjects received patellar resurfacing.
164775|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
164776|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
164777|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
164778|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
164779|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
164780|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing
164781|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
164782|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
164783|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
164784|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
164785|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
164786|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
164787|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
164788|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
164789|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
164790|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
164791|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
164792|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
164793|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
164794|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
164795|NCT01500252|E2|Reported Event|Patellar Retention|Subjects retained their native patella.
164796|NCT01500252|E1|Reported Event|Patellar Resurfacing|Subjects received patellar resurfacing.
164797|NCT01500226|B3|Baseline|Total|Total of all reporting groups
164798|NCT01500226|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy"
164799|NCT01500226|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy"
164800|NCT01500226|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy"
164974|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
192048|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
164801|NCT01500226|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy.
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy."
164802|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy"
164803|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy"
164804|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy"
164805|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy"
164806|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy"
164807|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy"
164808|NCT01500226|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy
685 subjects were randomized to control
674 of those who were randomized to control received control in C1
Safety = 674 control"
164809|NCT01500226|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
Dexamethasone (20 mg orally) about 30 min before chemotherapy
684 subjects were randomized to Rolapitant
670 of those randomized to Rolapitant received rolapitant in C1
Safety = 670 Rolapitant"
164810|NCT01500213|B3|Baseline|Total|Total of all reporting groups
164811|NCT01500213|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164812|NCT01500213|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164813|NCT01500213|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164814|NCT01500213|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164815|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164816|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164817|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164818|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164819|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164820|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164821|NCT01500213|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4
277 subjects were randomized to control;
274 of those who were randomized to control received control in C1.
Safety = 274 control"
164822|NCT01500213|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4
278 subjects were randomized to Rolapitant
272 of those randomized to Rolapitant received Rolapitant in C1
Safety = 272 Rolapitant"
164823|NCT01500135|B3|Baseline|Total|Total of all reporting groups
164824|NCT01500135|B2|Baseline|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164825|NCT01500135|B1|Baseline|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164826|NCT01500135|P2|Participant Flow|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164827|NCT01500135|P1|Participant Flow|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164828|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164829|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164830|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164831|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164832|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164833|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164834|NCT01500135|E2|Reported Event|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164835|NCT01500135|E1|Reported Event|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
164836|NCT01500109|B4|Baseline|Total|Total of all reporting groups
164837|NCT01500109|B3|Baseline|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.
Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
164838|NCT01500109|B2|Baseline|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.
Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
165088|NCT01499290|O6|Outcome|Meropenem (LFU)|LFU - 42 to 49 days after start of study drug
164839|NCT01500109|B1|Baseline|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.
Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
164840|NCT01500109|P3|Participant Flow|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.
Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
164841|NCT01500109|P2|Participant Flow|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.
Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
164842|NCT01500109|P1|Participant Flow|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.
Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
164843|NCT01500109|O3|Outcome|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.
Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
164844|NCT01500109|O2|Outcome|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.
Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
164845|NCT01500109|O1|Outcome|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.
Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
164846|NCT01500109|E3|Reported Event|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.
Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
164975|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
164847|NCT01500109|E2|Reported Event|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.
Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
164848|NCT01500109|E1|Reported Event|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.
Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
164849|NCT01500083|B3|Baseline|Total|Total of all reporting groups
164850|NCT01500083|B2|Baseline|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
164851|NCT01500083|B1|Baseline|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
164852|NCT01500083|P2|Participant Flow|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
164853|NCT01500083|P1|Participant Flow|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
164854|NCT01500083|O2|Outcome|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
164855|NCT01500083|O1|Outcome|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
164856|NCT01500083|E2|Reported Event|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
164857|NCT01500083|E1|Reported Event|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
164858|NCT01500031|B1|Baseline|Re-ROUTE|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
164859|NCT01500031|P1|Participant Flow|Re-ROUTE|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
164860|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164861|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164862|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164863|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164864|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164865|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164866|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164867|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164868|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164869|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164870|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164871|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164872|NCT01500031|E1|Reported Event|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
164873|NCT01499862|B1|Baseline|All Participants|All subjects had reached plateau with conventional Bodyweight-Supported Treadmill Training (BWSTT, participated in task-oriented mobility therapy(1.5 hours, 2-4 times per week for 4 weeks) with Robotic Leg Orthosis (RLO) under the supervision of a physical therapist.
164874|NCT01499862|P1|Participant Flow|Tibion Arm Baseline Assessments|Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
164875|NCT01499862|O3|Outcome|Patient 3|Ambulation speed (meters/second)
164876|NCT01499862|O2|Outcome|Patient 2|Ambulation speed (meters/second)
164877|NCT01499862|O1|Outcome|Patient 1|Ambulation speed (meters/second)
164878|NCT01499862|O3|Outcome|Patient 3|Step Length (meters)
164879|NCT01499862|O2|Outcome|Patient 2|Step Length (meters)
164880|NCT01499862|O1|Outcome|Patient 1|Step Length (meters)
164881|NCT01499862|O3|Outcome|Patient 3|Five Times Sit to Stand Test (seconds)
164892|NCT01499849|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164893|NCT01499849|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164894|NCT01499849|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164895|NCT01499849|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164896|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164897|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164898|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164899|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164900|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164901|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164902|NCT01499849|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164903|NCT01499849|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
164904|NCT01499810|B1|Baseline|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164905|NCT01499810|P1|Participant Flow|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164906|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164976|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
164977|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
165089|NCT01499290|O5|Outcome|CAZ-AVI + Metronidazole (LFU)|LFU - 42 to 49 days after start of study drug
164907|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164908|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164909|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164910|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164911|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164912|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164913|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164914|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164978|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
164979|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
164980|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
164915|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164916|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164917|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164918|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164919|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164920|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164921|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164922|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164981|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
164982|NCT01499667|E3|Reported Event|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
164983|NCT01499667|E2|Reported Event|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
164923|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164924|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164925|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164926|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164927|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164928|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164929|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164930|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164984|NCT01499667|E1|Reported Event|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
164985|NCT01499654|B1|Baseline|Study Group|Entire cohort
164986|NCT01499654|P1|Participant Flow|Study Group|Entire cohort
164987|NCT01499654|O3|Outcome|Injection 1 to Injection 2|Time in minutes between the first 1/2 dose injection and the second 1/2 dose injection
164988|NCT01499654|O2|Outcome|Injection 2 to Scan 2|Time in minutes between the second 1/2 dose injection and the second scan.
164931|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164932|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164933|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164934|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164935|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164936|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164937|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164938|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164989|NCT01499654|O1|Outcome|Injection 1 to Scan 1|Time in minutes between the first 1/2 dose injection and the first scan
164990|NCT01499654|O1|Outcome|Study Group|Entire cohort
164991|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
164992|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
164993|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
164939|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164940|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164941|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164942|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164943|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164944|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164945|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164946|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164994|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
164995|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
164996|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
164997|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
192049|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
164947|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164948|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164949|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164950|NCT01499810|E1|Reported Event|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
164951|NCT01499667|B4|Baseline|Total|Total of all reporting groups
164952|NCT01499667|B3|Baseline|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod
164953|NCT01499667|B2|Baseline|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
164954|NCT01499667|B1|Baseline|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
164955|NCT01499667|P3|Participant Flow|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
164956|NCT01499667|P2|Participant Flow|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
164957|NCT01499667|P1|Participant Flow|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
164958|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
164959|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
164960|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
164961|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
164962|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
164963|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
164964|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
164965|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
164966|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
164967|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
164968|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
164969|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
164970|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
164971|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
165008|NCT01499576|O1|Outcome|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
165009|NCT01499576|E1|Reported Event|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
165010|NCT01499498|B1|Baseline|Sildenafil and Boceprevir|All subjects take single dose sildenafil 25mg day 0, day 10-15 they take boceprevir 800mg three times a day followed by Intentive PK on day 15 and on day 16 single dose of sildenafil and boceprevir together followed by intensive PK
165011|NCT01499498|P1|Participant Flow|Sildenafil and Boceprevir|"Healthy volunteers
Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
165012|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers
Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
165013|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers
Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
165014|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers
Sildenafil and Boceprevir: 25mg once/800mg three times a day"
165015|NCT01499498|O1|Outcome|Bocepreprivir Alone|"Healthy volunteers
Boceprevir: 800mg three times a day"
165016|NCT01499498|O1|Outcome|Sildenafil Only|"Healthy volunteers
Sildenafil 25mg once"
165017|NCT01499498|E1|Reported Event|Sildenafil and Boceprevir|"Healthy volunteers
Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
165018|NCT01499355|B1|Baseline|All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
165019|NCT01499355|P4|Participant Flow|Double-Blind Period: BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
165020|NCT01499355|P3|Participant Flow|Double-Blind Period: BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
165021|NCT01499355|P2|Participant Flow|Double-Blind Period: Placebo|Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
165022|NCT01499355|P1|Participant Flow|Run-In Period: All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received mycophenolate mofetil (MMF) starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
165023|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165024|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165025|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165026|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165027|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165028|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165029|NCT01499355|O1|Outcome|Run-In: All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
165030|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165031|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165032|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165033|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165034|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165035|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165036|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165090|NCT01499290|O4|Outcome|Meropenem (TOC)|TOC - 28 to 35 days after start of study drug
165037|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165038|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165039|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165040|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165041|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165042|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165043|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165044|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165045|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165046|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165047|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165048|NCT01499355|E4|Reported Event|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165049|NCT01499355|E3|Reported Event|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165050|NCT01499355|E2|Reported Event|Placebo|Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
165051|NCT01499355|E1|Reported Event|Run-in Period|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
165052|NCT01499303|B3|Baseline|Total|Total of all reporting groups
165053|NCT01499303|B2|Baseline|200mg BID|200mg Fostmatinib BID
165054|NCT01499303|B1|Baseline|100mg BID|100mg Fostmatinib BID
165055|NCT01499303|P2|Participant Flow|200mg BID|200mg Fostmatinib BID
165056|NCT01499303|P1|Participant Flow|100mg BID|100mg Fostmatinib BID
165057|NCT01499303|O2|Outcome|200mg BID|200mg Fostmatinib BID
165058|NCT01499303|O1|Outcome|100mg BID|100mg Fostmatinib BID
165059|NCT01499303|E2|Reported Event|200mg BID|200mg Fostmatinib BID
165060|NCT01499303|E1|Reported Event|100mg BID|100mg Fostmatinib BID
165061|NCT01499290|B3|Baseline|Total|Total of all reporting groups
165062|NCT01499290|B2|Baseline|Meropenem|1000 mg: IV treatment
165063|NCT01499290|B1|Baseline|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
165064|NCT01499290|P2|Participant Flow|Meropenem|1000 mg: IV treatment
165065|NCT01499290|P1|Participant Flow|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
165066|NCT01499290|O6|Outcome|AVI (3)|300-360 mins after dose
165067|NCT01499290|O5|Outcome|CAZ (3)|300-360 mins after dose
165068|NCT01499290|O4|Outcome|AVI (2)|30-90 mins after dose
165069|NCT01499290|O3|Outcome|CAZ (2)|30-90 mins after dose
165070|NCT01499290|O2|Outcome|AVI (1)|30 min before/after dose
165071|NCT01499290|O1|Outcome|CAZ (1)|30 mins before/after dose
165072|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
165073|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
165074|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
165075|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
165076|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
165077|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Number of patients with pathogen at baseline
165078|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
165079|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
165080|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
165081|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Number of patients with pathogen at baseline
165082|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
165083|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
165084|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
165085|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Total number of patiets with each pathogen at baseline (summary only shows pathogens where N>/=10)
165086|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment. Number of favourable responses
165087|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment Number of favourable responses
165099|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole (EOT)|EOT - within 24 hours of last dose of study drug
165100|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
165105|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
165106|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
165107|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
165108|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
165109|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
165110|NCT01499290|E2|Reported Event|Meropenem|1000 mg: IV treatment
165111|NCT01499290|E1|Reported Event|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment.
165112|NCT01499277|B3|Baseline|Total|Total of all reporting groups
165113|NCT01499277|B2|Baseline|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165114|NCT01499277|B1|Baseline|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165115|NCT01499277|P2|Participant Flow|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165116|NCT01499277|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165117|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165118|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165119|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165120|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165121|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165122|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165123|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165124|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165125|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165126|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165127|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165128|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165129|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165130|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165131|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165132|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165133|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165134|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165135|NCT01499277|E2|Reported Event|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
165136|NCT01499277|E1|Reported Event|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
165137|NCT01499199|B1|Baseline|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165138|NCT01499199|P1|Participant Flow|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165139|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165140|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165141|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165142|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165143|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165144|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165145|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165146|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165147|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165148|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165149|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165150|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165151|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165152|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165153|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165154|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165155|NCT01499199|E1|Reported Event|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
165156|NCT01499147|B3|Baseline|Total|Total of all reporting groups
165324|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
165157|NCT01499147|B2|Baseline|Arm 2|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.
fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
165158|NCT01499147|B1|Baseline|Arm 1|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.
fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
165159|NCT01499147|P2|Participant Flow|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.
fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
165160|NCT01499147|P1|Participant Flow|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.
fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
165161|NCT01499147|O2|Outcome|Fludarabine/Melphalan +ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.
fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
165162|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.
fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
165163|NCT01499147|O2|Outcome|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.
fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).
ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen."
165164|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.
fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.
ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen."
165165|NCT01499147|O2|Outcome|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.
fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
165166|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.
fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
165167|NCT01499147|O2|Outcome|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.
fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
165168|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.
fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
165169|NCT01499147|E3|Reported Event|FluMel Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluMel and receiving PBSC.
165170|NCT01499147|E2|Reported Event|FluBu Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and receiving PBSC.
165171|NCT01499147|E1|Reported Event|Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and FluMel and receiving PBSC.
165172|NCT01499134|B3|Baseline|Total|Total of all reporting groups
165173|NCT01499134|B2|Baseline|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily
Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
165174|NCT01499134|B1|Baseline|Nebivolol|"nebivolol 1 to 4 capsules daily
nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
165175|NCT01499134|P2|Participant Flow|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily
Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
165176|NCT01499134|P1|Participant Flow|Nebivolol|"nebivolol 1 to 4 capsules daily
nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
165177|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily
Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
165178|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily
nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
165179|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily
Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
165180|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily
nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
165181|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily
Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
165182|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily
nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
165183|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily
Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
165184|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily
nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
165185|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily
Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
165186|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily
nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
165187|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily
Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
165188|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily
nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
165189|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily
Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
165229|NCT01499082|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue.
165190|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily
nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
165191|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily
Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
165192|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily
nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
165193|NCT01499134|E2|Reported Event|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily
Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
165194|NCT01499134|E1|Reported Event|Nebivolol|"nebivolol 1 to 4 capsules daily
nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
165195|NCT01499095|B3|Baseline|Total|Total of all reporting groups
165196|NCT01499095|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165197|NCT01499095|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165198|NCT01499095|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s).
165199|NCT01499095|P1|Participant Flow|HOE901-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s).
165200|NCT01499095|O2|Outcome|HOE901­U300: Fixed Dosing Intervals|HOE901­U300 SC injection once daily for 12 months in combination with of oral antidiabetic drug(s). From Month 6 up to Month 9 participants received HOE901­U300 once daily every 24 hours.
165201|NCT01499095|O1|Outcome|HOE901­U300: Adaptable Dosing Intervals|HOE901­U300 SC injection once daily for 6 months in combination with oral antidiabetic drug(s). From Month 6 to Month 9 participants received HOE901­U300 once daily at intervals of 24 +/­ 3 hours.
165202|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165203|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165204|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165205|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165206|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165207|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165208|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165209|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165210|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165211|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165212|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165213|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165214|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165215|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165216|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165217|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165218|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on in combination with antidiabetic drug(s).
165219|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165220|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165221|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165222|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165223|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165224|NCT01499095|E2|Reported Event|LANTUS|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165225|NCT01499095|E1|Reported Event|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
165226|NCT01499082|B3|Baseline|Total|Total of all reporting groups
165227|NCT01499082|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165228|NCT01499082|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
192050|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
165230|NCT01499082|P1|Participant Flow|HOE901-U300|HOE901­U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of mealtime insulin analogue.
165363|NCT01498640|E1|Reported Event|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
165364|NCT01498601|B3|Baseline|Total|Total of all reporting groups
165231|NCT01499082|O2|Outcome|HOE901-U300: Fixed Dosing Intervals|HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 up to Month 9 participants received HOE901-U300 once daily every 24 hours.
165232|NCT01499082|O1|Outcome|HOE901-U300: Adaptable Dosing Intervals|HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 to Month 9 participants received HOE901-U300 once daily at intervals of 24 +/- 3 hours.
165233|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165234|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165235|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165236|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165237|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165238|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165239|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165240|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165241|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165242|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165243|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165244|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165245|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165246|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165247|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165248|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165249|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165250|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165251|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165252|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165253|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165254|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165255|NCT01499082|E2|Reported Event|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
165256|NCT01499082|E1|Reported Event|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
165257|NCT01498822|B3|Baseline|Total Title|
165258|NCT01498822|B2|Baseline|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group
150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
165259|NCT01498822|B1|Baseline|Levetiracetam|"Levetiracetam twice a day treatment Group
250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
165260|NCT01498822|P2|Participant Flow|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group
150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
165261|NCT01498822|P1|Participant Flow|Levetiracetam|"Levetiracetam twice a day treatment Group
250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
165262|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
165263|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
165264|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
165265|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
165266|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
165267|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
165268|NCT01498822|O2|Outcome|Per Protocol Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
165269|NCT01498822|O1|Outcome|Per Protocol Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
165270|NCT01498822|E2|Reported Event|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group
150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
165271|NCT01498822|E1|Reported Event|Levetiracetam|"Levetiracetam twice a day treatment Group
250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
165272|NCT01498744|B3|Baseline|Total|Total of all reporting groups
165485|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165323|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
165273|NCT01498744|B2|Baseline|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165274|NCT01498744|B1|Baseline|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165275|NCT01498744|P2|Participant Flow|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165276|NCT01498744|P1|Participant Flow|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165277|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165278|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165279|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165280|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165281|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165282|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165283|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165321|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
165322|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
165399|NCT01498458|P1|Participant Flow|Pazopanib Plus Capecitabine|The baseline refers only to the 8 patients who received Pazopanib.
165284|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165285|NCT01498744|E2|Reported Event|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165286|NCT01498744|E1|Reported Event|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
165287|NCT01498692|B1|Baseline|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165288|NCT01498692|P1|Participant Flow|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165289|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165290|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165291|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165292|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165293|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165294|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165295|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165296|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165297|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165298|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165299|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165300|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165301|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165302|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165303|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165304|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165305|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165306|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165307|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165308|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165309|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165310|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165311|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165312|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165313|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165314|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165315|NCT01498692|E1|Reported Event|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
165316|NCT01498679|B3|Baseline|Total|Total of all reporting groups
165317|NCT01498679|B2|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
165318|NCT01498679|B1|Baseline|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
165319|NCT01498679|P2|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 100/25 micrograms (µg) OD in the evening,via a DPI, for a period of 12 weeks.
165320|NCT01498679|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening,via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
165397|NCT01498549|E1|Reported Event|Atomoxetine 40 mg|Atomoxetine 40 mg dose
165325|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
165326|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
165327|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
165328|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
165329|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
165330|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
165331|NCT01498679|E2|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
165332|NCT01498679|E1|Reported Event|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
165333|NCT01498653|B3|Baseline|Total|Total of all reporting groups
165334|NCT01498653|B2|Baseline|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
165335|NCT01498653|B1|Baseline|Fluticasone Furoate/Vilanterol 200/25 µg OD|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
165336|NCT01498653|P2|Participant Flow|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
165337|NCT01498653|P1|Participant Flow|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening,via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
165338|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
165339|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
165340|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
165341|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
165342|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
165343|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
165344|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
165345|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
165346|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
165347|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
165348|NCT01498653|E2|Reported Event|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
165349|NCT01498653|E1|Reported Event|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
165350|NCT01498640|B1|Baseline|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
165351|NCT01498640|P1|Participant Flow|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
165352|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
165353|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
165354|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
165355|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
165356|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
165357|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
165358|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
165359|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
165360|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
165361|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
165362|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
165365|NCT01498601|B2|Baseline|Retrospective Study Group|Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified through a retrospective chart review for the same in-patient unit.
165366|NCT01498601|B1|Baseline|Oral Care Treatment Group|Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified upon admission to the in-patient unit during the study period.
165367|NCT01498601|P2|Participant Flow|Oral Care Treatment Group|"All subjects in the intervention group received the enhanced oral care protocol:
Changing mouth suction equipment every 24 hours
Mouth assessment every 2-4 hours
Cleansing mouth with toothbrush every 12 hours
Cleansing oral mucosa with oral rinse solution every 2-4 hours
Moisturize mouth/lips with swab and standard mouth moisturizer every 4 hours
Suction mouth and throat as needed
Head of the bed elevated to a minimum of 30° during oral care"
165368|NCT01498601|P1|Participant Flow|Retrospective Study Group|A retrospective chart review identified matched in-patients meeting the study inclusion criteria.
165369|NCT01498601|O2|Outcome|Retrospective Study Group|Acute neurologically impaired adults in the retrospective chart review
165370|NCT01498601|O1|Outcome|Oral Care Treatment Group|Acute neurologically impaired adults receiving the study protocol
165371|NCT01498601|E2|Reported Event|Retrospective Study Group|Subjects were identified through a chart review process for in-patients on the study unit unit during the retrospective study period and met the inclusion criteria .
165372|NCT01498601|E1|Reported Event|Oral Care Treatment Group|Subjects meeting the inclusion criteria and identified at the point of admission to the in-patient unit during the study period.
165373|NCT01498588|B1|Baseline|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:
Day 1: Eribulin 1.4mg/m² IV
Day 8: Eribulin 1.4mg/m² IV
Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:
Day 1: Doxorubicin 60mg/m² IV
Day 1: Cyclophosphamide 600mg/m² IV
Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
165374|NCT01498588|P1|Participant Flow|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:
Day 1: Eribulin 1.4mg/m² IV
Day 8: Eribulin 1.4mg/m² IV
Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:
Day 1: Doxorubicin 60mg/m² IV
Day 1: Cyclophosphamide 600mg/m² IV
Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
165375|NCT01498588|O1|Outcome|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:
Day 1: Eribulin 1.4mg/m² IV
Day 8: Eribulin 1.4mg/m² IV
Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:
Day 1: Doxorubicin 60mg/m² IV
Day 1: Cyclophosphamide 600mg/m² IV
Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
165376|NCT01498588|O1|Outcome|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:
Day 1: Eribulin 1.4mg/m² IV
Day 8: Eribulin 1.4mg/m² IV
Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:
Day 1: Doxorubicin 60mg/m² IV
Day 1: Cyclophosphamide 600mg/m² IV
Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
165377|NCT01498588|E1|Reported Event|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:
Day 1: Eribulin 1.4mg/m² IV
Day 8: Eribulin 1.4mg/m² IV
Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:
Day 1: Doxorubicin 60mg/m² IV
Day 1: Cyclophosphamide 600mg/m² IV
Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
165378|NCT01498575|B3|Baseline|Total|Total of all reporting groups
165379|NCT01498575|B2|Baseline|Usual Practice|Use of typical supervised practice driving resources
165380|NCT01498575|B1|Baseline|Teen Driving Plan|"Access to web-based driving intervention
Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
165381|NCT01498575|P2|Participant Flow|Usual Practice (Control)|Use of typical supervised practice driving resources
165382|NCT01498575|P1|Participant Flow|Teen Driving Plan (TDP)|"Access to web-based driving intervention
Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
165383|NCT01498575|O2|Outcome|Usual Practice (Control)|Participants received a hard copy of the Pennsylvania driver's manual, also available online and at licensing centers.
165384|NCT01498575|O1|Outcome|Teen Driving Plan (TDP)|Access to web-based driving intervention that provides practice supervisors with specific guidance for facilitating supervision of teens' practice drives across several environments and conditions (eg., highways, commercial districts) using brief instructional videos and resources.
165385|NCT01498575|E2|Reported Event|Usual Practice (Control)|Use of typical supervised practice driving resources
165386|NCT01498575|E1|Reported Event|Teen Driving Plan (TDP)|"Access to web-based driving intervention
Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
165387|NCT01498549|B1|Baseline|Total Sample|This is the summary of the total sample used in the crossover design.
165388|NCT01498549|P1|Participant Flow|Participants|Participants were randomly assigned to one of 3 possible groups over a 3 day assessment period.
165389|NCT01498549|O3|Outcome|Sugar Pill 0mg|Sugar pill 0 mg dose
165390|NCT01498549|O2|Outcome|Atomoxetine 80 mg|Atomoxetine 80 mg dose
165391|NCT01498549|O1|Outcome|Atomoxetine 40 mg|Atomoxetine 40 mg dose
165392|NCT01498549|O3|Outcome|Sugar Pill 0mg|Sugar pill 0mg dose
165393|NCT01498549|O2|Outcome|Atomoxetine 80 mg|Atomoxetine 80 mg dose
165394|NCT01498549|O1|Outcome|Atomoxetine 40 mg|Atomoxetine 40 mg dose
165395|NCT01498549|E3|Reported Event|Sugar Pill 0 mg|Sugar pill 0 mg dose
165396|NCT01498549|E2|Reported Event|Atomoxetine 80 mg|Atomoxetine 80 mg dose
165400|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|2 patients were on study treatment for a long time.
165401|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|
165402|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|pazopanib together with capecitabine
165403|NCT01498458|O1|Outcome|Pazopanib + Capecitabine|Pazopanib and Capecitabine
165489|NCT01498185|O3|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165404|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|The following DLTs resulted in permanent discontinuation of the study therapy: hypertension, (DLT 1), mucositis CTC grade 3, hand-foot-syndrome CTC grade 3, increase of liver enzymes (GOT,- and GPT) CTC grade 2 (DLT 2), and increase of liver enzymes (GOT-, GPT) CTC grade 3 (DLT 3).
165405|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.
165406|NCT01498458|E1|Reported Event|Pazopanib Plus Capecitabine|There was only one arm in this study as this was a dose escalation study.
165407|NCT01498419|B5|Baseline|Total|Total of all reporting groups
165408|NCT01498419|B4|Baseline|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165409|NCT01498419|B3|Baseline|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
165410|NCT01498419|B2|Baseline|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165411|NCT01498419|B1|Baseline|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165412|NCT01498419|P4|Participant Flow|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165413|NCT01498419|P3|Participant Flow|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
165414|NCT01498419|P2|Participant Flow|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165415|NCT01498419|P1|Participant Flow|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165416|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165417|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
165418|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165419|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165420|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165421|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
165422|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165423|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165424|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165425|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
165426|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165427|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165428|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165429|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
165469|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165430|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165490|NCT01498185|O2|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
165431|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165432|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165433|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
165434|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165435|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165436|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165437|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
165438|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165439|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165440|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165441|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
165442|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165443|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165444|NCT01498419|E4|Reported Event|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165445|NCT01498419|E3|Reported Event|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
165446|NCT01498419|E2|Reported Event|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165447|NCT01498419|E1|Reported Event|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
165448|NCT01498185|B6|Baseline|Total|Total of all reporting groups
165449|NCT01498185|B5|Baseline|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
165450|NCT01498185|B4|Baseline|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165451|NCT01498185|B3|Baseline|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165452|NCT01498185|B2|Baseline|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
165453|NCT01498185|B1|Baseline|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
165454|NCT01498185|P5|Participant Flow|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
165455|NCT01498185|P4|Participant Flow|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165456|NCT01498185|P3|Participant Flow|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165457|NCT01498185|P2|Participant Flow|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
165458|NCT01498185|P1|Participant Flow|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
165459|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
165460|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165461|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165462|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
165463|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
165464|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165465|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165466|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
165467|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
165468|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165486|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
165487|NCT01498185|O5|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
165488|NCT01498185|O4|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165491|NCT01498185|O1|Outcome|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
165492|NCT01498185|E5|Reported Event|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
165493|NCT01498185|E4|Reported Event|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165494|NCT01498185|E3|Reported Event|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
165495|NCT01498185|E2|Reported Event|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
165496|NCT01498185|E1|Reported Event|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
165497|NCT01498120|B1|Baseline|Rotigotine|Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
165498|NCT01498120|P1|Participant Flow|Rotigotine|Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
165499|NCT01498120|O1|Outcome|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
165500|NCT01498120|O1|Outcome|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
165501|NCT01498120|E1|Reported Event|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
165502|NCT01498068|B3|Baseline|Total|Total of all reporting groups
165503|NCT01498068|B2|Baseline|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165504|NCT01498068|B1|Baseline|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165505|NCT01498068|P2|Participant Flow|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165506|NCT01498068|P1|Participant Flow|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165507|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165508|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165509|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165510|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165511|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165577|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir (SOF)+RBV for 12 weeks.
165578|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
165512|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165582|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
165513|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165514|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165515|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165516|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165517|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165518|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165519|NCT01498068|E2|Reported Event|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165520|NCT01498068|E1|Reported Event|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
165521|NCT01497938|B3|Baseline|Total|Total of all reporting groups
165522|NCT01497938|B2|Baseline|Control Arm|"The Low Glucose Suspend feature will not be available to subjects in the control arm
Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low."
165523|NCT01497938|B1|Baseline|Low Glucose Suspend Feature (LGS)|"According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study
Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low."
165524|NCT01497938|P2|Participant Flow|Control Arm|"The Low Glucose Suspend feature will not be available to subjects in the control arm
Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low."
165525|NCT01497938|P1|Participant Flow|Low Glucose Suspend Feasure (LGS)|"According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study
Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low."
165526|NCT01497938|O2|Outcome|Group B Without Low Glucose Suspend (LGS) Feature|
165527|NCT01497938|O1|Outcome|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
165528|NCT01497938|O2|Outcome|Group B Without Low Glucose Suspend (LGS) Feature|
165529|NCT01497938|O1|Outcome|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
165530|NCT01497938|E2|Reported Event|Group B Without Low Glucose Suspend (LGS) Feature|
165531|NCT01497938|E1|Reported Event|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
165532|NCT01497899|B5|Baseline|Total|Total of all reporting groups
165533|NCT01497899|B4|Baseline|DRV+COBI+TVD to Open-Label E/C/F/TAF|Participants previously received DRV+COBI+TVD in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
165534|NCT01497899|B3|Baseline|D/C/F/TAF to Open-Label E/C/F/TAF|Participants previously received D/C/F/TAF in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
165535|NCT01497899|B2|Baseline|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165536|NCT01497899|B1|Baseline|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165537|NCT01497899|P4|Participant Flow|DRV+COBI+TVD to Open-Label E/C/F/TAF|Participants previously received darunavir (DRV) + cobicistat (COBI) + truvada (TVD) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
167033|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
165538|NCT01497899|P3|Participant Flow|D/C/F/TAF to Open-Label E/C/F/TAF|Participants previously received darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
165539|NCT01497899|P2|Participant Flow|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165540|NCT01497899|P1|Participant Flow|E/C/F/TAF|"Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165541|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165542|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165543|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165544|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165545|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165546|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165547|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165548|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165549|NCT01497899|E3|Reported Event|All E/C/F/TAF|"Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF.
Participants received blinded or open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165550|NCT01497899|E2|Reported Event|E/C/F/TDF|"Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TDF.
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks; Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165551|NCT01497899|E1|Reported Event|E/C/F/TAF|"Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TAF.
Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks; Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
165552|NCT01497756|B1|Baseline|CAPP Application|Patients in whom device is used
165553|NCT01497756|P1|Participant Flow|CAPP Application|Patients in whom device is used
165554|NCT01497756|O1|Outcome|CAPP Application|Patients in whom device is used
165555|NCT01497756|O1|Outcome|CAPP Application|Patients in whom device is used
165556|NCT01497756|E1|Reported Event|CAPP Application|Patients in whom device is used
165557|NCT01497665|B1|Baseline|GRN1005 Alone|"GRN1005 alone
GRN1005: 650 mg/m2 IV every 3 weeks"
165558|NCT01497665|P1|Participant Flow|GRN1005 Alone|"GRN1005 alone
GRN1005: 650 mg/m2 IV every 3 weeks"
165559|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone
GRN1005: 650 mg/m2 IV every 3 weeks"
165560|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone
GRN1005: 650 mg/m2 IV every 3 weeks"
165561|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone
GRN1005: 650 mg/m2 IV every 3 weeks"
165562|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone
GRN1005: 650 mg/m2 IV every 3 weeks"
165563|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone
GRN1005: 650 mg/m2 IV every 3 weeks"
165564|NCT01497665|E1|Reported Event|GRN1005 Alone|"GRN1005 alone
GRN1005: 650 mg/m2 IV every 3 weeks"
165565|NCT01497366|B3|Baseline|Total|Total of all reporting groups
165566|NCT01497366|B2|Baseline|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
165567|NCT01497366|B1|Baseline|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
165568|NCT01497366|P2|Participant Flow|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
165569|NCT01497366|P1|Participant Flow|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks.
165570|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
165571|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
165572|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
165573|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
165574|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
165575|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir (SOF)+RBV for 12 weeks.
165576|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
165579|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
165580|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
165581|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
165583|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
165584|NCT01497366|E2|Reported Event|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
165585|NCT01497366|E1|Reported Event|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
165586|NCT01497275|B1|Baseline|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
165587|NCT01497275|P1|Participant Flow|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
165588|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
165589|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
165590|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
165591|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
165592|NCT01497275|E1|Reported Event|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
165593|NCT01497262|B1|Baseline|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
165594|NCT01497262|P1|Participant Flow|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
165595|NCT01497262|O1|Outcome|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
165596|NCT01497262|O1|Outcome|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
165597|NCT01497262|E1|Reported Event|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
165598|NCT01497197|B3|Baseline|Total|Total of all reporting groups
165599|NCT01497197|B2|Baseline|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165600|NCT01497197|B1|Baseline|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165601|NCT01497197|P2|Participant Flow|Gonal-f® Followed by Luveris|GONAL-f® (Liquid Pen; 300 IU per day) stimulation Day 1-5 then added Luveris® (vial/powder, 150 IU per day) from stimulation day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice.
165602|NCT01497197|P1|Participant Flow|Gonal-f®+Luveris|GONAL f® (Liquid Pen; 300 international units [IU] of per day) stimulation Day 1-5 then followed by Luveris® (vial/powder, 150 IU per day) from stimulation Day 1 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice.
165681|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165603|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165604|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165605|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165606|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165607|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165608|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165609|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165610|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165611|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165612|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165613|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165614|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165615|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165616|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165617|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165641|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
192051|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
165642|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
165684|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165618|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165619|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165620|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165621|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165622|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165623|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165624|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165625|NCT01497197|E2|Reported Event|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165626|NCT01497197|E1|Reported Event|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
165627|NCT01497171|B3|Baseline|Total|Total of all reporting groups
165628|NCT01497171|B2|Baseline|Anterior Colporrhaphy|Traditional suture repair of anterior vaginal prolapse
165629|NCT01497171|B1|Baseline|Elevate Mesh|Transvaginal mesh repair of anterior vaginal prolapse
165630|NCT01497171|P2|Participant Flow|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse
Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
165631|NCT01497171|P1|Participant Flow|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse
Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
165632|NCT01497171|O2|Outcome|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse
Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
165633|NCT01497171|O1|Outcome|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse
Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
165634|NCT01497171|E2|Reported Event|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse
Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
165635|NCT01497171|E1|Reported Event|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse
Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
165636|NCT01496807|B1|Baseline|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
165637|NCT01496807|P1|Participant Flow|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
165638|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
165639|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
165640|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
168454|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
165643|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
165644|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
165645|NCT01496807|E1|Reported Event|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
165646|NCT01496469|B3|Baseline|Total|Total of all reporting groups
165647|NCT01496469|B2|Baseline|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
165648|NCT01496469|B1|Baseline|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
165649|NCT01496469|P2|Participant Flow|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
165650|NCT01496469|P1|Participant Flow|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
165651|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
165652|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
165653|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
165654|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
165655|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
165656|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
165657|NCT01496469|E2|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
165658|NCT01496469|E1|Reported Event|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
165659|NCT01496456|B1|Baseline|Lesion Infiltration and Preventative Management Only|"Paired split-mouth study: both arms in same patient (2 study teeth). A) Resin infiltration therapy in addition to preventative caries management B) Preventative caries management only
SOC Baseline preventative caries management: dietary and behavioral modification, and OTC fluoride supplements"
165660|NCT01496456|P1|Participant Flow|Lesion Infiltration and Preventative Management Only|"Paired split-mouth study: both arms (arm A and arm B) were applied in same patient (2 study teeth).
A) Resin infiltration therapy in addition to SOC Preventative caries management B) SOC Preventative caries management only.
––– Standard Of Care (SOC) Baseline preventative caries management included dietary and behavioral modification, and over-the-counter (OTC) fluoride supplements."
165661|NCT01496456|O2|Outcome|Preventative Measures|"Caries management by preventative measures only: oral hygiene instruction, diet counseling and fluoride supplementation
Baseline SOC preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
165662|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
165663|NCT01496456|O2|Outcome|Preventative Measures|"Caries management by preventative measures only: oral hygiene instruction, diet counseling and fluoride supplementation
Baseline SOC preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
165664|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
165665|NCT01496456|O2|Outcome|Preventative Measures|SOC Caries management by preventative measures only.
165666|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
165667|NCT01496456|E2|Reported Event|Preventative Measures|"Caries management by preventative measures only
SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
165668|NCT01496456|E1|Reported Event|Lesion Infiltration|"Resin infiltration of caries lesion in addition to SOC caries management by preventative measures
SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
165669|NCT01496430|B4|Baseline|Total|Total of all reporting groups
165670|NCT01496430|B3|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165671|NCT01496430|B2|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165672|NCT01496430|B1|Baseline|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165673|NCT01496430|P3|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165674|NCT01496430|P2|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165675|NCT01496430|P1|Participant Flow|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165676|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165677|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165678|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165679|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165680|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
192052|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
165682|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165683|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165685|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165686|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165687|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165688|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165689|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165690|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165691|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165692|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165693|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165694|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165695|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165696|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165697|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165698|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165699|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165700|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165701|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165702|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165703|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165704|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165705|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165706|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165707|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165708|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165709|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165710|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165711|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165712|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165713|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165714|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165715|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165716|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165717|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165718|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165719|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165720|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165721|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165722|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165723|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165724|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165725|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165726|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165727|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165728|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165729|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165730|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165731|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165732|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165733|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165734|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165735|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165736|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165737|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165738|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165739|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165740|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165741|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165742|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165743|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165744|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165745|NCT01496430|E3|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
165746|NCT01496430|E2|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
165747|NCT01496430|E1|Reported Event|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
165748|NCT01496352|B3|Baseline|Total|Total of all reporting groups
165749|NCT01496352|B2|Baseline|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
165750|NCT01496352|B1|Baseline|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
165751|NCT01496352|P2|Participant Flow|DFA-02 Placebo|Progressive cohorts of 2 patients per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
165752|NCT01496352|P1|Participant Flow|DFA-02|"Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
DFA-02: Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure"
165753|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02 placebo
165754|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL DFA-02
165755|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subject per cohort receiving up to 10, 20 or 30 mL DFA-02 placebo
165756|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02
165757|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving 10, 20 or 30 mL DFA-02 placebo
165758|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02
165759|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 and 30 mL of DFA-02 placebo
165760|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 18 subjects receiving up to 10, 20 or 30 mL of DFA-02
165761|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
165762|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
165763|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects receiving 10, 20 or 30 mL of DFA-02 placebo
165764|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL of DFA-02
165765|NCT01496352|E2|Reported Event|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
165766|NCT01496352|E1|Reported Event|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
165767|NCT01496313|B3|Baseline|Total|Total of all reporting groups
165768|NCT01496313|B2|Baseline|Vandetanib 300 mg|Oral blinded tablet, taken once daily
165769|NCT01496313|B1|Baseline|Vandetanib 150 mg|Oral blinded tablet, taken once daily
165770|NCT01496313|P2|Participant Flow|Vandetanib 300 mg|Oral blinded tablet, taken once daily
165771|NCT01496313|P1|Participant Flow|Vandetanib 150 mg|Oral blinded tablet, taken once daily
165772|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
165773|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
165774|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
165775|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
165776|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
165777|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
165778|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
165779|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
165780|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
165781|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
165782|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
165783|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
165784|NCT01496313|E2|Reported Event|Vandetanib 300 mg|Oral blinded tablet, taken once daily
165785|NCT01496313|E1|Reported Event|Vandetanib 150 mg|Oral blinded tablet, taken once daily
165814|NCT01496274|O1|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
165786|NCT01496287|B1|Baseline|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
165787|NCT01496287|P1|Participant Flow|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
165788|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
165789|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
165790|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
165791|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
165792|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
165793|NCT01496287|E1|Reported Event|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
165794|NCT01496274|B3|Baseline|Total|Total of all reporting groups
165795|NCT01496274|B2|Baseline|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.
rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration"
165796|NCT01496274|B1|Baseline|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.
rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration"
165797|NCT01496274|P2|Participant Flow|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165798|NCT01496274|P1|Participant Flow|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165799|NCT01496274|O3|Outcome|Prophylaxis Arm, 14-day Regimen|Subjects received prophylactic rIX-FP every 14 days.
165800|NCT01496274|O2|Outcome|Prophylaxis Arm, 10-day Regimen|Subjects received prophylactic rIX-FP every 10 days.
165801|NCT01496274|O1|Outcome|Prophylaxis Arm, 7-day Regimen|Subjects received prophylactic rIX-FP on a weekly basis.
165802|NCT01496274|O1|Outcome|Surgical Population|The Surgical population consisted of 3 subjects in the prophylaxis arm and 1 subject in the on demand arm who received at least 1 dose of rIX FP for a major or minor surgical procedure.
165803|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165804|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165805|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165806|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165807|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165808|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165809|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165810|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165811|NCT01496274|O4|Outcome|Prophylaxis Arm, 14-day Regimen|Subjects received prophylactic rIX-FP every 14 days.
165812|NCT01496274|O3|Outcome|Prophylaxis Arm, 10-day Regimen|Subjects received prophylactic rIX-FP every 10 days.
165813|NCT01496274|O2|Outcome|Prophylaxis Arm, 7-day Regimen|Subjects received prophylactic rIX-FP on a weekly basis.
166738|NCT01493180|O2|Outcome|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
165815|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165933|NCT01495858|B3|Baseline|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165816|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165817|NCT01496274|O3|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
165818|NCT01496274|O2|Outcome|On-demand Arm, On-demand Regimen|Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
165819|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165820|NCT01496274|O1|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
165821|NCT01496274|O3|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
165822|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165823|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165824|NCT01496274|O1|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
165825|NCT01496274|O2|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
165826|NCT01496274|O1|Outcome|On-demand Arm, On-demand Regimen|Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
165827|NCT01496274|E2|Reported Event|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165828|NCT01496274|E1|Reported Event|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.
Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
165829|NCT01496248|B1|Baseline|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
165830|NCT01496248|P1|Participant Flow|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
165831|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
165832|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
165833|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
165834|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
165835|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
165836|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
165837|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
165838|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
165839|NCT01496248|E1|Reported Event|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
165840|NCT01496183|B3|Baseline|Total|Total of all reporting groups
165841|NCT01496183|B2|Baseline|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
165842|NCT01496183|B1|Baseline|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
166739|NCT01493180|O1|Outcome|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
165843|NCT01496183|P2|Participant Flow|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
165844|NCT01496183|P1|Participant Flow|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
165845|NCT01496183|O2|Outcome|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
165846|NCT01496183|O1|Outcome|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.
165847|NCT01496183|E2|Reported Event|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
165848|NCT01496183|E1|Reported Event|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
165849|NCT01495988|B5|Baseline|Total|Total of all reporting groups
165850|NCT01495988|B4|Baseline|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165851|NCT01495988|B3|Baseline|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165852|NCT01495988|B2|Baseline|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165853|NCT01495988|B1|Baseline|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165854|NCT01495988|P4|Participant Flow|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165855|NCT01495988|P3|Participant Flow|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165856|NCT01495988|P2|Participant Flow|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165857|NCT01495988|P1|Participant Flow|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165858|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165859|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165860|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165875|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165970|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165931|NCT01495923|E1|Reported Event|Epidural Steroids|"Injection of steroids into the epidural space
epidural steroid injection: Injection of steroids and local anesthetic into the epidural space
Placebo gabapentin: Titration of placebo gabapentin"
165932|NCT01495858|B4|Baseline|Total|Total of all reporting groups
165861|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165862|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165863|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165864|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165865|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165866|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165867|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165868|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165869|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165870|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165871|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165872|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165873|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165874|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
168455|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
165876|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165877|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165878|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165879|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165880|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165881|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165882|NCT01495988|O4|Outcome|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165883|NCT01495988|O3|Outcome|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165884|NCT01495988|O2|Outcome|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165885|NCT01495988|O1|Outcome|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165886|NCT01495988|E4|Reported Event|Vemurafenib + Bevacizumab|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165887|NCT01495988|E3|Reported Event|Vemurafenib|"Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients.
Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter."
165888|NCT01495988|E2|Reported Event|Vemurafenib/Cobimetinib + Bevacizumab|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165929|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165930|NCT01495923|E2|Reported Event|Gabapentin|"Titration of gabapentin to effect
Sham epidural steroid injection: Injection of saline into the back muscles
Gabapentin: Titration of gabapentin to effect"
165889|NCT01495988|E1|Reported Event|Vemurafenib/Cobimetinib|"Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression."
165890|NCT01495975|B3|Baseline|Total|Total of all reporting groups
165891|NCT01495975|B2|Baseline|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.
Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
165892|NCT01495975|B1|Baseline|Usual Care|Usual care for diabetes in the 1 month after discharge.
165893|NCT01495975|P2|Participant Flow|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.
Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
165894|NCT01495975|P1|Participant Flow|Usual Care|Usual care for diabetes in the 1 month after discharge.
165895|NCT01495975|O2|Outcome|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.
Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
165896|NCT01495975|O1|Outcome|Usual Care|Usual care for diabetes in the 1 month after discharge.
165897|NCT01495975|E2|Reported Event|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.
Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
165898|NCT01495975|E1|Reported Event|Usual Care|Usual care for diabetes in the 1 month after discharge.
165899|NCT01495923|B3|Baseline|Total|Total of all reporting groups
165900|NCT01495923|B2|Baseline|Gabapentin|Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive real gabapentin and a placebo injection as treatment.
165901|NCT01495923|B1|Baseline|Epidural Steriod Injections|Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive a real epidural steroid injection and placebo medication as treatment.
165902|NCT01495923|P2|Participant Flow|Gabapentin|If randomized to this group participants received gabapentin medication and a placebo intramuscular injection. The gabapentin was uptitrated to a therapeutic dose using a titration schedule.
165903|NCT01495923|P1|Participant Flow|Epidural Steroid Injection|If randomized to this group, participants received either a transforaminal injection for unilateral pain or an interlaminar injection for bilateral pain and placebo medication. The level and type of injection to be given was determined by signs, symptoms, and radiological findings.
165904|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
165905|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165906|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
165907|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165908|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
165909|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165910|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
165911|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165912|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
165913|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165914|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
165915|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165916|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
165917|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165918|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
165919|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165920|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
165921|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165922|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
165923|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165924|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
165925|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
165926|NCT01495923|O2|Outcome|Epidural Steroid|This group received an epidural steroid injection and placebo gabapentin.
165927|NCT01495923|O1|Outcome|Gabapentin Group|This group received gabapentin and a placebo intramuscular injection.
165928|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
168456|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
165934|NCT01495858|B2|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165935|NCT01495858|B1|Baseline|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165936|NCT01495858|P3|Participant Flow|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165937|NCT01495858|P2|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165938|NCT01495858|P1|Participant Flow|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165939|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165940|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165941|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165942|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165943|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165944|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165945|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165946|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165947|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165948|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165949|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165950|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165951|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165952|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165953|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165954|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165955|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165956|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165957|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165958|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165959|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165960|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165961|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165962|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165963|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165964|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165965|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165966|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165967|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165968|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165969|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
166740|NCT01493180|E2|Reported Event|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
165971|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165972|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165973|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165974|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165975|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165976|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165977|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165978|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165979|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165980|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165981|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165982|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165983|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165984|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165985|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165986|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165987|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165988|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165989|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165990|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165991|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165992|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165993|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165994|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165995|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165996|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
165997|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
165998|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
165999|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
166000|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
166001|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
166002|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
166003|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
166004|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
166005|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
166006|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
166007|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
166008|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
166009|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
192053|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
166010|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
166011|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
166012|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
166013|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
166014|NCT01495858|E3|Reported Event|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
166015|NCT01495858|E2|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally
166016|NCT01495858|E1|Reported Event|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally
166017|NCT01495793|B1|Baseline|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
166018|NCT01495793|P1|Participant Flow|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
166019|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
166020|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
166021|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
166022|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
166023|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
166024|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
166025|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
166026|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
166027|NCT01495793|E1|Reported Event|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
166028|NCT01495702|B3|Baseline|Total|Total of all reporting groups
166029|NCT01495702|B2|Baseline|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
166030|NCT01495702|B1|Baseline|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
166031|NCT01495702|P2|Participant Flow|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
166032|NCT01495702|P1|Participant Flow|Stribild|Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
166033|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
166034|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
166035|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
166036|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
166037|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
166038|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
166039|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
166392|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166040|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
167161|NCT01491490|O2|Outcome|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
166041|NCT01495702|E3|Reported Event|All Stribild|Adverse events for this reporting group include those occurring in all participants while receiving Stribild in the randomized and extension phases.
166042|NCT01495702|E2|Reported Event|NNRTI+FTC/TDF (Randomized Phase)|"Adverse events for this reporting group include those occurring in participants receiving NNRTI+FTC/TDF in the randomized phase.
Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase."
166043|NCT01495702|E1|Reported Event|Stribild (Randomized Phase)|"Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase.
Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase."
166044|NCT01495689|B3|Baseline|Total|Total of all reporting groups
166045|NCT01495689|B2|Baseline|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids
Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
166046|NCT01495689|B1|Baseline|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing
Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
166047|NCT01495689|P2|Participant Flow|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids
Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
166048|NCT01495689|P1|Participant Flow|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing
Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
166049|NCT01495689|O2|Outcome|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids
Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
166050|NCT01495689|O1|Outcome|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing
Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
166051|NCT01495689|E2|Reported Event|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids
Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
166052|NCT01495689|E1|Reported Event|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing
Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
166053|NCT01495585|B4|Baseline|Total|Total of all reporting groups
166054|NCT01495585|B3|Baseline|Lonafarnib 200 mg|"4 participants were randomized to Lonafarnib 200 mg and two Placebo participants in Lonafarnib 100 mg arm received open label lonafarnib 200 mg ."
166055|NCT01495585|B2|Baseline|Lonafarnib 100 mg|6 participants were randomized to Lonafarnib 100 mg.
166056|NCT01495585|B1|Baseline|Placebo|placebo control.
166057|NCT01495585|P3|Participant Flow|Lonafarnib 200 mg|4 participants were randomized to Lonafarnib 200 mg.
166058|NCT01495585|P2|Participant Flow|Lonafarnib 100 mg|6 participants were randomized to Lonafarnib 100 mg.
166059|NCT01495585|P1|Participant Flow|Placebo|Two placebo participants in Group1 and two placebo participants in Group 2. The two placebo participants in Group 1 received open label lonafarnib 200 mg.
166060|NCT01495585|O3|Outcome|Group 2|lonafarnib 200 mg
166061|NCT01495585|O2|Outcome|Group 1|lonafarnib 100 mg
166062|NCT01495585|O1|Outcome|Placebo|"placebo control.
Group 1 placebo participants received open-label lonafarnib as group 2 participants.
Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
166063|NCT01495585|O3|Outcome|Group 2|lonafarnib 200 mg
166064|NCT01495585|O2|Outcome|Group 1|lonafarnib 100 mg
166065|NCT01495585|O1|Outcome|Placebo|"placebo control.
Group 1 placebo participants received open-label lonafarnib as group 2 participants.
Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
166066|NCT01495585|E3|Reported Event|Group 2|lonafarnib 200 mg
166067|NCT01495585|E2|Reported Event|Group 1|lonafarnib 100 mg
166068|NCT01495585|E1|Reported Event|Placebo|"placebo control.
Group 1 placebo participants received open-label lonafarnib as group 2 participants.
Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
166069|NCT01495572|B3|Baseline|Total|Total of all reporting groups
166070|NCT01495572|B2|Baseline|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0
Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days(day -5 to -1)
Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6
MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
166088|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT
Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
166071|NCT01495572|B1|Baseline|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x1011 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.
Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)
Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6
Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6
MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
166072|NCT01495572|P2|Participant Flow|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0
Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)
Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6
MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
166073|NCT01495572|P1|Participant Flow|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.
Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)
Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6
Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6
MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
166074|NCT01495572|O2|Outcome|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x1011 IV over 20-30 minutes on day 0
Fludarabine: 25 mg/m2 IV (in the vein) for 5 days(day -5 to -1)
Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6
MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
166075|NCT01495572|O1|Outcome|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.
Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)
Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6
Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6
MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
166076|NCT01495572|O2|Outcome|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0
Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)
Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6
MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
166077|NCT01495572|O1|Outcome|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.
Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)
Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6
Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6
MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
166078|NCT01495572|E2|Reported Event|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0
Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days(day -5 to -1)
Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6
MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
166079|NCT01495572|E1|Reported Event|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x1011 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.
Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)
Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6
Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6
MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
166080|NCT01495481|B1|Baseline|Adenosine and Dexmedetomidine|Patients will receive both adenosine and dexmedetomidine for the termination of SVT.
166081|NCT01495481|P1|Participant Flow|Adenosine and Dexmedetomidine|Patients will receive adenosine for termination of SVT, and then dexmedetomidine for the termination of supraventricular tachycardia (SVT) and comparison will be made for efficacy and safety.
166082|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT
Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
166083|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)
Dexmedetomidine: Dexmedetomidine 2 mcg/kg, Intravenous push"
166084|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT
Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
166085|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)
Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
166086|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT
Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
166087|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)
Dexmedetomidine: Dexmedetomidine 2 mcg/kg, Intravenous push"
166741|NCT01493180|E1|Reported Event|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
166089|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of SVT
Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
166090|NCT01495481|E2|Reported Event|Adenosine|"Patients will receive Adenosine for the termination of SVT
Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
166091|NCT01495481|E1|Reported Event|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of SVT
Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
166092|NCT01495286|B1|Baseline|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
166093|NCT01495286|P1|Participant Flow|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
166094|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
166095|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
166096|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
166097|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
166098|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
166099|NCT01495286|E1|Reported Event|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
166100|NCT01495000|B3|Baseline|Total|Total of all reporting groups
166101|NCT01495000|B2|Baseline|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166102|NCT01495000|B1|Baseline|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166103|NCT01495000|P2|Participant Flow|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166104|NCT01495000|P1|Participant Flow|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166105|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166106|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166107|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166108|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166109|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166110|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166111|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166112|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166113|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166114|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166115|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166116|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166117|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166118|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166119|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166120|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166121|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166122|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166123|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166124|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166125|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166126|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166127|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166128|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166129|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166130|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166131|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166132|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166133|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166134|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166135|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166136|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166137|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166138|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166139|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166140|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166141|NCT01495000|E2|Reported Event|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
166142|NCT01495000|E1|Reported Event|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
166143|NCT01494987|B3|Baseline|Total|Total of all reporting groups
166144|NCT01494987|B2|Baseline|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen."
166145|NCT01494987|B1|Baseline|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen."
166194|NCT01494649|P1|Participant Flow|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
192054|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
166195|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
168476|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
166146|NCT01494987|P2|Participant Flow|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen."
166147|NCT01494987|P1|Participant Flow|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen."
166148|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen."
166149|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen."
166150|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen."
166151|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen."
166152|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen."
166153|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen."
166154|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen."
166155|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen."
166156|NCT01494987|E2|Reported Event|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.
Participants were required to maintain their diet and exercise regimen."
166157|NCT01494987|E1|Reported Event|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.
Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.
Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.
Participants were required to maintain their diet and exercise regimen."
166158|NCT01494818|B3|Baseline|Total|Total of all reporting groups
166159|NCT01494818|B2|Baseline|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166160|NCT01494818|B1|Baseline|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166161|NCT01494818|P2|Participant Flow|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166162|NCT01494818|P1|Participant Flow|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166163|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166164|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166165|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166166|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166167|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166168|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166169|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166170|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166171|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166172|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166173|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166174|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166175|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166176|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166177|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166178|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166179|NCT01494818|E2|Reported Event|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166180|NCT01494818|E1|Reported Event|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
166181|NCT01494753|B3|Baseline|Total|Total of all reporting groups
166182|NCT01494753|B2|Baseline|T2345/Prostaglandin|One drop at 8.00pm.
166183|NCT01494753|B1|Baseline|Prostaglandin/T2345|One drop at 8.00pm.
166184|NCT01494753|P2|Participant Flow|T2345/Prostaglandin|One drop at 8.00pm.
166185|NCT01494753|P1|Participant Flow|Prostaglandin/T2345|One drop at 8.00pm.
166186|NCT01494753|O2|Outcome|T2345/Prostaglandin|One drop at 8.00pm.
166187|NCT01494753|O1|Outcome|Prostaglandin/T2345|One drop at 8.00pm.
166188|NCT01494753|E2|Reported Event|T2345|One drop at 8.00pm.
166189|NCT01494753|E1|Reported Event|Prostaglandin|One drop at 8.00pm.
166190|NCT01494649|B3|Baseline|Total|Total of all reporting groups
166191|NCT01494649|B2|Baseline|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
166192|NCT01494649|B1|Baseline|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
166193|NCT01494649|P2|Participant Flow|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
166196|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
166197|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
166198|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
166199|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
166200|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
166201|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
166202|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeths for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
166203|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
166204|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
166205|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily.
166206|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
166207|NCT01494649|E2|Reported Event|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
166208|NCT01494649|E1|Reported Event|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute, for 14 days twice daily. The test product is a commercially available product.
166209|NCT01494610|B1|Baseline|FP/Salmeterol 250/50 mcg|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in one of two sequences in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively: ABBA, BAAB. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
166210|NCT01494610|P2|Participant Flow|FP/Salmeterol 250/50 mcg: Sequence BAAB|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of BAAB in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
166211|NCT01494610|P1|Participant Flow|FP/Salmeterol 250/50 mcg: Sequence ABBA|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of ABBA in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
166212|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166213|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166214|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166215|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166216|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166217|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166218|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
168457|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
166396|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166219|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166220|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166221|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166222|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166223|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166224|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166225|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166226|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166227|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166228|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166229|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166230|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166231|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166232|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166233|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166234|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166235|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166236|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166237|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166238|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166239|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166240|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166241|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166242|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166243|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166244|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166245|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166246|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166658|NCT01493947|E2|Reported Event|Metronidazole 0.75% Cream Period A|Metronidazole 0.75% cream applied twice daily on the face during 16-week
166247|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166248|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166249|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166250|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166251|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166252|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166253|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166254|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166255|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166256|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166257|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166258|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166259|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166260|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166261|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166262|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166263|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166264|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166265|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166266|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166267|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166268|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
166269|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
166270|NCT01494610|E8|Reported Event|FP/Salmeterol From Capsule-based Inhaler 2nd Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
166271|NCT01494610|E7|Reported Event|FP/Salmeterol From Capsule-based Inhaler 1st Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
166272|NCT01494610|E6|Reported Event|FP/Salmeterol From MDPI 2nd Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
166273|NCT01494610|E5|Reported Event|FP/Salmeterol From MDPI 1st Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
166393|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166274|NCT01494610|E4|Reported Event|FP/Salmeterol From Capsule-based Inhaler 2nd Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
166275|NCT01494610|E3|Reported Event|FP/Salmeterol From Capsule-based Inhaler 1st Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
166276|NCT01494610|E2|Reported Event|FP/Salmeterol From MDPI 2nd Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to particiapants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
166277|NCT01494610|E1|Reported Event|FP/Salmeterol From MDPI 1st Administration (Admin), Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
166278|NCT01494584|B1|Baseline|Ezogabine/Retigabine|Participants received an initial dose of ezogabine/retigabine 300 milligrams (mg) per day administered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166279|NCT01494584|P1|Participant Flow|Ezogabine/Retigabine|Participants recieved an initial dose of ezogabine/retigabine 300 milligrams (mg) per day administered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166280|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166281|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166282|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166283|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166284|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166285|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166286|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166287|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166394|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
168458|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
166288|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166289|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166290|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166291|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166292|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166293|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166294|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166295|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166296|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166297|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166298|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166299|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166348|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an uptitrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166300|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166301|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166302|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R)300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166303|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166304|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166305|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly upitration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166306|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166307|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166308|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166309|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants recieved an initial dose of ezogabine/retigabine 300 mg/day administered as 100 mg IR tablets TID orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166310|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166311|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of>50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166395|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
168459|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
166312|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166313|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166314|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166315|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166316|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166317|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166318|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166319|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166320|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166321|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166322|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166323|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166349|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166659|NCT01493947|E1|Reported Event|Ivermectin 1% Cream Period A|Ivermectin applied once daily on the face during 16-week
166324|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166325|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166326|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166327|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166328|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166329|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166330|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166331|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166332|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166333|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166334|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166335|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166390|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166660|NCT01493687|B3|Baseline|Total|Total of all reporting groups
192055|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
166336|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166337|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166338|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166339|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166340|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166341|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166342|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166343|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166344|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166345|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166346|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166347|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166735|NCT01493180|B1|Baseline|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
166350|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166351|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166352|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166353|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166354|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166355|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166356|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166357|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166358|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166359|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166360|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166361|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants (par.) with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166391|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166736|NCT01493180|P2|Participant Flow|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
166362|NCT01494584|E5|Reported Event|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166363|NCT01494584|E4|Reported Event|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166364|NCT01494584|E3|Reported Event|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166365|NCT01494584|E2|Reported Event|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166366|NCT01494584|E1|Reported Event|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
166367|NCT01494545|B1|Baseline|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166368|NCT01494545|P1|Participant Flow|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166369|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166370|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166371|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166372|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166373|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166374|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166375|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166376|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
166377|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
166378|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166379|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
166380|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
166381|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166382|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
166383|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
166384|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166385|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166386|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166387|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166388|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166389|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166397|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166398|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166399|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166400|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166401|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166402|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166403|NCT01494545|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
166404|NCT01494532|B7|Baseline|Total|Total of all reporting groups
166405|NCT01494532|B6|Baseline|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166406|NCT01494532|B5|Baseline|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166407|NCT01494532|B4|Baseline|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166408|NCT01494532|B3|Baseline|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166409|NCT01494532|B2|Baseline|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166410|NCT01494532|B1|Baseline|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166411|NCT01494532|P6|Participant Flow|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166412|NCT01494532|P5|Participant Flow|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166413|NCT01494532|P4|Participant Flow|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166414|NCT01494532|P3|Participant Flow|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166648|NCT01493947|B2|Baseline|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
166649|NCT01493947|B1|Baseline|Ivermectin|Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.
166742|NCT01493167|B1|Baseline|Woodcast Circular System Casts|Operatively treated adult patients needing a post-operative Circular Woodcast scaphoid-type cast
166415|NCT01494532|P2|Participant Flow|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166416|NCT01494532|P1|Participant Flow|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166417|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166418|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166419|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166420|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166421|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166422|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166423|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166424|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166425|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166426|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166427|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166428|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166650|NCT01493947|P2|Participant Flow|Metronidazole 0.75% Cream|Metronidazole 0.75% cream applied twice daily on the face during 16-week
166651|NCT01493947|P1|Participant Flow|Ivermectin|Ivermectin applied once daily on the face during 16-week
192056|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
166429|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166430|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166431|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166432|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166433|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166434|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166435|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166436|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166437|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166438|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166439|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166440|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166441|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166442|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166443|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166444|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166445|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166446|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166447|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166448|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166449|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166450|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166451|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166452|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166453|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166454|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166455|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166456|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
192057|NCT01402115|E2|Reported Event|Placebo|Placebo 15mg for 12 weeks
166457|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166458|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166459|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166460|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166461|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166462|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166463|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166464|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166465|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166466|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166467|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166468|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166469|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166470|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166652|NCT01493947|O2|Outcome|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
166653|NCT01493947|O1|Outcome|CD5024|CD5024: CD5024 applied once daily on the face during 16-week plus 36-week extension period.
166471|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166472|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166473|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166474|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166475|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166476|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166477|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166478|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166479|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166480|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166481|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166482|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166483|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166484|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166485|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166486|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166487|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166488|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166489|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166490|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166491|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166492|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166493|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166494|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166495|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166496|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166497|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166498|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
192058|NCT01402115|E1|Reported Event|Polycan|Polycan 150mg for 12 weeks
166499|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166500|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166501|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166502|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166503|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166504|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166505|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166506|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166507|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166508|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166509|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166510|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166511|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166512|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166654|NCT01493947|O2|Outcome|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
166655|NCT01493947|O1|Outcome|Ivermectin|Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.
166513|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166514|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166515|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166516|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166517|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166518|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166519|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166520|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166521|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166522|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166523|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166524|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166525|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166526|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166527|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166528|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166529|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166530|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166531|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166532|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166533|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166534|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166535|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166536|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166537|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166538|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166539|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166540|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
192059|NCT01402102|B3|Baseline|Total|Total of all reporting groups
166541|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166542|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166543|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166544|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166545|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166546|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166547|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166548|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166549|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166550|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166551|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166552|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166553|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166554|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166656|NCT01493947|E4|Reported Event|Metronidazole 0.75% Cream Period B|36-week extension period : only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible.
166737|NCT01493180|P1|Participant Flow|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
166555|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166556|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166557|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166558|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166559|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166560|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166561|NCT01494532|E6|Reported Event|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166562|NCT01494532|E5|Reported Event|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166563|NCT01494532|E4|Reported Event|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166564|NCT01494532|E3|Reported Event|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166565|NCT01494532|E2|Reported Event|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
166566|NCT01494532|E1|Reported Event|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
166567|NCT01494506|B4|Baseline|Total|Total of all reporting groups
166568|NCT01494506|B3|Baseline|MM-398, 5-FU and Leucovorin|"MM-398, 5-FU and Leucovorin Q2W IV
MM-398: Arm A: MM-398 120 mg/m2 IV Q3W
Arm C: MM-398 80mg/m2 IV Q2W
5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks
Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
166569|NCT01494506|B2|Baseline|5 Fluorouracil and Leucovorin IV|"5 Fluorouracil and Leucovorin IV
5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks
Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
166570|NCT01494506|B1|Baseline|MM-398|"MM-398 Q3W IV
MM-398: Arm A: MM-398 120 mg/m2 IV Q3W
Arm C: MM-398 80mg/m2 IV Q2W"
192103|NCT01401907|O1|Outcome|Early Palliative Care|
166571|NCT01494506|P3|Participant Flow|MM-398 + 5-FU + Leucovorin (Arm C)|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.
5-FU 2400 mg/m2 IV over 46-hours, and
Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
166572|NCT01494506|P2|Participant Flow|5-FU + Leucovorin (Arm B)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166573|NCT01494506|P1|Participant Flow|MM-398 (Arm A)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
166574|NCT01494506|O2|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.
5-FU 2400 mg/m2 IV over 46-hours, and
Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
166575|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
166576|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166577|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.
5-FU 2400 mg/m2 IV over 46-hours, and
Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
166578|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166579|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
166580|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166581|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.
5-FU 2400 mg/m2 IV over 46-hours, and
Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
166582|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166583|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
166584|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166585|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.
5-FU 2400 mg/m2 IV over 46-hours, and
Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
166586|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166657|NCT01493947|E3|Reported Event|Ivermectin 1% Cream Period B|36-week extension period :only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible
168460|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
166587|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
166588|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166589|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.
5-FU 2400 mg/m2 IV over 46-hours, and
Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
166590|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166591|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
166592|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166593|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.
5-FU 2400 mg/m2 IV over 46-hours, and
Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
166594|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166595|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
166596|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166597|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.
5-FU 2400 mg/m2 IV over 46-hours, and
Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
166598|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166599|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
166600|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166601|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.
5-FU 2400 mg/m2 IV over 46-hours, and
Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
166602|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
166603|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
166604|NCT01494506|E3|Reported Event|MM-398, 5-FU and Leucovorin|"MM-398, 5-FU and Leucovorin Q2W IV
MM-398: Arm A: MM-398 120 mg/m2 IV Q3W
Arm C: MM-398 80mg/m2 IV Q2W
5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks
Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
166605|NCT01494506|E2|Reported Event|5 Fluorouracil and Leucovorin IV|"5 Fluorouracil and Leucovorin IV
5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks
Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
166606|NCT01494506|E1|Reported Event|MM-398|"MM-398 Q3W IV
MM-398: Arm A: MM-398 120 mg/m2 IV Q3W
Arm C: MM-398 80mg/m2 IV Q2W"
166607|NCT01494467|B3|Baseline|Total|Total of all reporting groups
166608|NCT01494467|B2|Baseline|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks"
166609|NCT01494467|B1|Baseline|CD5024 1% Cream|"Part A: CD5024 1% Cream, once daily application for 12 weeks
Part B: CD5024 1% Cream, once daily application for 40 weeks"
166610|NCT01494467|P2|Participant Flow|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application
Part B: Azelaic acid 15% Gel, twice daily application"
166611|NCT01494467|P1|Participant Flow|CD5024 1% Cream|Part A & B: CD5024 1% Cream, once daily application
166612|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
166613|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
166614|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
166615|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
166616|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
166617|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
166618|NCT01494467|E8|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall|Overall number of subjects with adverse events for the entire duration of study
166619|NCT01494467|E7|Reported Event|CD5024 1% Cream - Overall|Overall number of subjects with adverse events for the entire duration of study
166620|NCT01494467|E6|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C|Part C: 4 week safety follow up. No drug applications
166621|NCT01494467|E5|Reported Event|CD5024 1% Cream - Part C|Part C: 4 week safety follow up. No drug applications
166622|NCT01494467|E4|Reported Event|Azelaic Acid 15% Gel - Part B|Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
166623|NCT01494467|E3|Reported Event|CD5024 1% Cream - Part B|Part B CD5024 1% Cream, once daily application for 40 weeks
166624|NCT01494467|E2|Reported Event|CD5024 Vehicle Cream - Part A|Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
166625|NCT01494467|E1|Reported Event|CD5024 1% Cream - Part A|Part A: CD5024 1% Cream, once daily application for 12 weeks
166626|NCT01494350|B1|Baseline|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
166627|NCT01494350|P1|Participant Flow|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
166628|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
166629|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
166630|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
166631|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
166632|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
166633|NCT01494350|E1|Reported Event|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
166634|NCT01494298|B3|Baseline|Total|Total of all reporting groups
166635|NCT01494298|B2|Baseline|Controls|African American Men without diabetes
166636|NCT01494298|B1|Baseline|T2DM|African American Men with Type 2 Diabetes
166637|NCT01494298|P2|Participant Flow|Controls|African American men without type 2 diabetes and not taking cholesterol-lowering medications.
166638|NCT01494298|P1|Participant Flow|T2DM|African American men with type 2 diabetes and not taking cholesterol-lowering medications.
166639|NCT01494298|O2|Outcome|Controls|
166640|NCT01494298|O1|Outcome|T2DM|
166641|NCT01494298|O2|Outcome|Controls|African-American men without type 2 diabetes who are not taking cholesterol lowering medications
166642|NCT01494298|O1|Outcome|T2DM|African-American men with type 2 diabetes who are not taking cholesterol lowering medications
166643|NCT01494298|O2|Outcome|Controls|
166644|NCT01494298|O1|Outcome|T2DM|
166645|NCT01494298|E2|Reported Event|Controls|African American men without type 2 diabetes and not taking cholesterol-lowering medications.
166646|NCT01494298|E1|Reported Event|T2DM|African American men with type 2 diabetes and not taking cholesterol-lowering medications.
166647|NCT01493947|B3|Baseline|Total|Total of all reporting groups
168461|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
166661|NCT01493687|B2|Baseline|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks"
166662|NCT01493687|B1|Baseline|CD5024 1% Cream|Part A: CD5024 1% Cream, once daily application for 12 weeks Part B: CD5024 1% Cream, once daily application for 40 weeks
166663|NCT01493687|P2|Participant Flow|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application
Part B: Azelaic acid 15% Gel, twice daily application"
166664|NCT01493687|P1|Participant Flow|CD5024 1% Cream|Part A & B: CD5024 1% Cream, once daily application
166665|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
166666|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
166667|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
166668|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
166669|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
166670|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
166671|NCT01493687|E8|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall|Overall number of subjects with adverse events for the entire duration of study
166672|NCT01493687|E7|Reported Event|CD5024 1% Cream - Overall|Overall number of subjects with adverse events for the entire duration of study
166673|NCT01493687|E6|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C|Part C: 4 week safety follow up. No drug applications
166674|NCT01493687|E5|Reported Event|CD5024 1% Cream - Part C|Part C: 4 week safety follow up. No drug applications
166675|NCT01493687|E4|Reported Event|Azelaic Acid 15% Gel - Part B|Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
166676|NCT01493687|E3|Reported Event|CD5024 1% Cream - Part B|Part B CD5024 1% Cream, once daily application for 40 weeks
166677|NCT01493687|E2|Reported Event|CD5024 Vehicle Cream - Part A|Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
166678|NCT01493687|E1|Reported Event|CD5024 1% Cream - Part A|Part A: CD5024 1% Cream, once daily application for 12 weeks
166679|NCT01493557|B4|Baseline|Total|Total of all reporting groups
166680|NCT01493557|B3|Baseline|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
166681|NCT01493557|B2|Baseline|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166682|NCT01493557|B1|Baseline|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166683|NCT01493557|P3|Participant Flow|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
166684|NCT01493557|P2|Participant Flow|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166685|NCT01493557|P1|Participant Flow|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166686|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166687|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166688|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166689|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166690|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166691|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166692|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166693|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166694|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166695|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166696|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166697|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166698|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166699|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166700|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166701|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166702|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166703|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166704|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166705|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166706|NCT01493557|E3|Reported Event|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
166707|NCT01493557|E2|Reported Event|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
166708|NCT01493557|E1|Reported Event|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
166709|NCT01493531|B4|Baseline|Total|Total of all reporting groups
166710|NCT01493531|B3|Baseline|Placebo + Allopurinol|
166711|NCT01493531|B2|Baseline|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
166712|NCT01493531|B1|Baseline|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
166713|NCT01493531|P3|Participant Flow|Placebo + Allopurinol|
166714|NCT01493531|P2|Participant Flow|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
166715|NCT01493531|P1|Participant Flow|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
166716|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
166717|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
166718|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
166719|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
166720|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
166721|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
166722|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
166723|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
166724|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
166725|NCT01493531|E3|Reported Event|Placebo + Allopurinol|
166726|NCT01493531|E2|Reported Event|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
166727|NCT01493531|E1|Reported Event|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
166728|NCT01493427|B1|Baseline|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
166729|NCT01493427|P1|Participant Flow|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
166730|NCT01493427|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
166731|NCT01493427|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
166732|NCT01493427|E1|Reported Event|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
166733|NCT01493180|B3|Baseline|Total|Total of all reporting groups
166734|NCT01493180|B2|Baseline|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
192244|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
166743|NCT01493167|P1|Participant Flow|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization
limb casting/splinting: ankle and arm cast"
166744|NCT01493167|O1|Outcome|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization
limb casting/splinting: ankle and arm cast"
166745|NCT01493167|E1|Reported Event|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization
limb casting/splinting: ankle and arm cast"
166746|NCT01493089|B3|Baseline|Total|Total of all reporting groups
166747|NCT01493089|B2|Baseline|Losec|Treatment of heartburn with Losec
166748|NCT01493089|B1|Baseline|Zegerid|Treatment of heartburn with Zegerid
166749|NCT01493089|P2|Participant Flow|Losec|Treatment of heartburn with 20mg Losec over-capsulated capsule plus placebo suspension once a day
166750|NCT01493089|P1|Participant Flow|Zegerid|Treatment of heartburn with 20mg Zegerid suspension plus over-encapsulated placebo capsule once a day
166751|NCT01493089|O2|Outcome|Losec Group|
166752|NCT01493089|O1|Outcome|Zegerid Group|
166753|NCT01493089|O2|Outcome|Losec Group|
166754|NCT01493089|O1|Outcome|Zegerid Group|
166755|NCT01493089|O2|Outcome|Losec Group|
166756|NCT01493089|O1|Outcome|Zegerid Group|
166757|NCT01493089|O2|Outcome|Losec Group|
166758|NCT01493089|O1|Outcome|Zegerid Group|
166759|NCT01493089|O2|Outcome|Losec Group|
166760|NCT01493089|O1|Outcome|Zegerid Group|
166761|NCT01493089|O2|Outcome|Losec Group|20mg Losec over-encapsulated capsule plus placebo suspension
166762|NCT01493089|O1|Outcome|Zegerid Group|20mg Zegerid suspension plus over-encapsulated placebo capsule
166763|NCT01493089|E2|Reported Event|Losec|Treatment of heartburn with Losec
166764|NCT01493089|E1|Reported Event|Zegerid|Treatment of heartburn with Zegerid
166765|NCT01492439|B3|Baseline|Total|Total of all reporting groups
166766|NCT01492439|B2|Baseline|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166767|NCT01492439|B1|Baseline|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166768|NCT01492439|P2|Participant Flow|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166769|NCT01492439|P1|Participant Flow|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a week for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166770|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166771|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166772|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166773|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166774|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166775|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166776|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166777|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166923|NCT01491919|P2|Participant Flow|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166956|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166778|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166779|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166780|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166781|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166782|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166783|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166784|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166785|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166786|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166787|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166788|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166789|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166790|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166791|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166792|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166793|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166794|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166795|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166796|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166797|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166798|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166799|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166800|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166801|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166802|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166803|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166804|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166805|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166806|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166807|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166808|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166809|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166810|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166811|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166812|NCT01492439|E2|Reported Event|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
166813|NCT01492439|E1|Reported Event|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
166814|NCT01492426|B3|Baseline|Total|Total of all reporting groups
166815|NCT01492426|B2|Baseline|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
166924|NCT01491919|P1|Participant Flow|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166816|NCT01492426|B1|Baseline|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
166817|NCT01492426|P2|Participant Flow|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
166818|NCT01492426|P1|Participant Flow|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
166819|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
166820|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
166821|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
166822|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
166823|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
166824|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
166825|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200mg per day was administered twice daily with food.
166826|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
166827|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
166828|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000 – 1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
166829|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
166830|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
166831|NCT01492426|E2|Reported Event|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food
168462|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
166832|NCT01492426|E1|Reported Event|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day)
166833|NCT01492400|B3|Baseline|Total|Total of all reporting groups
166834|NCT01492400|B2|Baseline|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
166835|NCT01492400|B1|Baseline|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
166836|NCT01492400|P2|Participant Flow|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
166837|NCT01492400|P1|Participant Flow|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
166838|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
166839|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
166840|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
166841|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
166842|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
166843|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
166844|NCT01492400|E2|Reported Event|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
166845|NCT01492400|E1|Reported Event|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
166846|NCT01492088|B4|Baseline|Total|Total of all reporting groups
166847|NCT01492088|B3|Baseline|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166848|NCT01492088|B2|Baseline|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166849|NCT01492088|B1|Baseline|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166850|NCT01492088|P3|Participant Flow|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166851|NCT01492088|P2|Participant Flow|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166852|NCT01492088|P1|Participant Flow|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166853|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166854|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166855|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166856|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166857|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166858|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166859|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166860|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166861|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166862|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166863|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166864|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166865|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166866|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166867|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166868|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166869|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166870|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166871|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166872|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166873|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166874|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166875|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
192245|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
166876|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166877|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166878|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166879|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166880|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166881|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166882|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166883|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166884|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166885|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166886|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166887|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166888|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166889|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166890|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166891|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166892|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r Hodgkin Lymphoma (HL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166893|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166922|NCT01491919|P3|Participant Flow|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166894|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166895|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166896|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166897|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166898|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166899|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166900|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166901|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166902|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166903|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166904|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166905|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166906|NCT01492088|E3|Reported Event|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166907|NCT01492088|E2|Reported Event|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
166908|NCT01492088|E1|Reported Event|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
166909|NCT01491984|B3|Baseline|Total|Total of all reporting groups
166910|NCT01491984|B2|Baseline|Intubation Order MAC/Levitan|A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice).
166911|NCT01491984|B1|Baseline|Intubation Order Levitan/MAC|The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.
166912|NCT01491984|P2|Participant Flow|Macintosh/Levitan FPS Laryngoscope Intubation Order|"traditional MAC intubation
laryngoscopy view with MAC :"
166913|NCT01491984|P1|Participant Flow|Levitan FPS/Mac Laryngoscope Intubation Order|"Intubation with Levitan
laryngoscopy view with Levitan :"
166914|NCT01491984|O2|Outcome|MAC/Levitan Intubation|Laryngoscopy with MAC then Levitan
166915|NCT01491984|O1|Outcome|Levitan/MAC Intubation|Laryngoscopy with Levitan, then MAC
166916|NCT01491984|E2|Reported Event|Macintosh Intubation|A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice)
166917|NCT01491984|E1|Reported Event|Levitan FPS Intubation|The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.
166918|NCT01491919|B4|Baseline|Total|Total of all reporting groups
166919|NCT01491919|B3|Baseline|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166920|NCT01491919|B2|Baseline|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166921|NCT01491919|B1|Baseline|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166925|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166926|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166927|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166928|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166929|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166930|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166931|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166932|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166933|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166934|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166935|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166936|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166937|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166938|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166939|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166940|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166941|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166942|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166943|NCT01491919|O2|Outcome|Lisinopril Standard of Care (SOC)|These protocol participants were enrolled and continued on the lisinopril dose prescribed as standard of care. They were assigned to the appropriate eGFR and dose level stratum (rounding to the closest dose level). Since the lisinopril dose was assigned based on standard of care, a patient was enrolled without regard to open/closed status of the dose stratum in this group. Therefore, over enrollment of a specific dose and eGFR stratum was allowed for participants enrolled he the Lisinopril-naive group to accommodate these valuable low-risk participants already taking lisinopril.
166944|NCT01491919|O1|Outcome|Lisinopril-naive|These protocol participants were not randomized. Instead, the older age group (7-17 years) were first enrolled consecutively into each dose level, starting with the lowest dose level (0.1 mg/kg per day). After enrollment is complete in the low dose level for an eGFR strata, enrollment will commence for the intermediate (0.2 mg/kg per day) dosage in that strata, followed by the high (0.4 mg/kg per day) dosage level. Enrollment for the 2-6 years age group did not begin until enrollment in the older age group (7-17 years) for the low and intermediate dosage level at each eGFR strata is complete.
166945|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166946|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166947|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166948|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166949|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166950|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166951|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166952|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166953|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166954|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166955|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
168463|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
166957|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166958|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166959|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166960|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166961|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166962|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166963|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166964|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166965|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166966|NCT01491919|E3|Reported Event|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
166967|NCT01491919|E2|Reported Event|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
166968|NCT01491919|E1|Reported Event|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
166969|NCT01491802|B1|Baseline|Randomized Subjects|All 17 randomized subjects.
166970|NCT01491802|P2|Participant Flow|LAMA/LABA, the LAMA|Participants first received the LAMA/LABA combination product (umeclidinium 125 mcg plus vilanterol 25 mcg) once daily for 4 weeks. After a 2 week washout period, they received LAMA alone (umeclidinium 125 mcg) once daily for 4 weeks.
166971|NCT01491802|P1|Participant Flow|LAMA, Then LAMA/LABA|Participants first received LAMA alone (umeclidinium 125 mcg) once daily for 4 weeks. After a 2 week washout period, they received the LAMA/LABA combination product (umeclidinium 125 mcg plus vilanterol 25 mcg) once daily for 4 weeks.
166972|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.
GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
166973|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist
GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
166974|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.
GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
166975|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist
GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
166976|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.
GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
166977|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist
GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
166978|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.
GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
166979|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist
GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
166980|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.
GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
166981|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist
GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
167028|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
167029|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
168464|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
167034|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
166982|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.
GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
166983|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist
GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
166984|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.
GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
166985|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist
GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
166986|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.
GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
166987|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist
GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
166988|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.
GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
166989|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist
GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
166990|NCT01491802|O2|Outcome|LABA/LAMA Combination|"GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.
GSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks."
166991|NCT01491802|O1|Outcome|LAMA|"GSK573719 is a long-acting muscarinic antagonist
GSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks"
166992|NCT01491802|E3|Reported Event|Washout Period|There was a 2 week washout period between the two treatment arms.
166993|NCT01491802|E2|Reported Event|LABA/LAMA Arm|The 4-week treatment period with once daily inhaled fixed-dose combination of umeclidinium (125 mcg) and vilanterol (25 mcg).
166994|NCT01491802|E1|Reported Event|LAMA Arm|The 4-week treatment period with once daily inhaled umeclidinium (125 mcg).
166995|NCT01491737|B3|Baseline|Total|Total of all reporting groups
166996|NCT01491737|B2|Baseline|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
166997|NCT01491737|B1|Baseline|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
166998|NCT01491737|P2|Participant Flow|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
166999|NCT01491737|P1|Participant Flow|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167030|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
167032|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
167000|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167001|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167002|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167003|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167004|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167005|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167006|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167007|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167008|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167009|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167031|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
167010|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167011|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167012|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167013|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167014|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167015|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167016|NCT01491737|E2|Reported Event|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167017|NCT01491737|E1|Reported Event|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
167018|NCT01491672|B4|Baseline|Total|Total of all reporting groups
167019|NCT01491672|B3|Baseline|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
167020|NCT01491672|B2|Baseline|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
167021|NCT01491672|B1|Baseline|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
167022|NCT01491672|P3|Participant Flow|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
167023|NCT01491672|P2|Participant Flow|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
167024|NCT01491672|P1|Participant Flow|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
167025|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
167026|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
167027|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
167035|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
167036|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
167037|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
167038|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
167039|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
167040|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
167041|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
167042|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
167043|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
167044|NCT01491672|O1|Outcome|All Participants|All participants received RAD001 10 mg daily.
167045|NCT01491672|E3|Reported Event|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
167046|NCT01491672|E2|Reported Event|Other Prior Anti VEGF|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
167047|NCT01491672|E1|Reported Event|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
167048|NCT01491633|B1|Baseline|Dasatinib|"Dasatinib 140 mg by mouth each day
Dasatinib: 140 mg orally, daily in 28 day cycles"
167049|NCT01491633|P1|Participant Flow|Dasatinib|"Dasatinib 140 mg by mouth each day
Dasatinib: 140 mg orally, daily in 28 day cycles"
167050|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day
Dasatinib: 140 mg orally, daily in 28 day cycles"
167051|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day
Dasatinib: 140 mg orally, daily in 28 day cycles"
167052|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day
Dasatinib: 140 mg orally, daily in 28 day cycles"
167053|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day
Dasatinib: 140 mg orally, daily in 28 day cycles"
167054|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day
Dasatinib: 140 mg orally, daily in 28 day cycles"
167055|NCT01491633|E1|Reported Event|Dasatinib|"Dasatinib 140 mg by mouth each day
Dasatinib: 140 mg orally, daily in 28 day cycles"
167056|NCT01491607|B5|Baseline|Total|Total of all reporting groups
167057|NCT01491607|B4|Baseline|BioThrax - Site 04|Subjects from Site 04 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
167058|NCT01491607|B3|Baseline|BioThrax - Site 03|Subjects from Site 03 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
167059|NCT01491607|B2|Baseline|BioThrax - Site 02|Subjects from Site 02 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
167060|NCT01491607|B1|Baseline|BioThrax - Site 01|Subjects from Site 01 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
167061|NCT01491607|P1|Participant Flow|BioThrax|Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
167062|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167063|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167064|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167065|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167066|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167067|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167068|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167069|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167070|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
168465|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
167160|NCT01491490|P1|Participant Flow|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
167071|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167072|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167073|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167074|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167075|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167076|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167077|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167078|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167079|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167080|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167081|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167082|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167083|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167084|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167085|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167086|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167087|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167088|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167089|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167090|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167091|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167092|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167093|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167094|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167095|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167096|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167097|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167098|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167099|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167100|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167101|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167102|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167103|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167104|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167105|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167106|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167107|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167108|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167109|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167110|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167111|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167112|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167113|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167114|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167115|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167116|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167117|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167118|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167119|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167120|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167121|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
167122|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
167123|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
167124|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
167125|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
167155|NCT01491607|E1|Reported Event|ITT Population|Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
167156|NCT01491490|B3|Baseline|Total|Total of all reporting groups
167157|NCT01491490|B2|Baseline|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
167126|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
167127|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
167128|NCT01491607|O5|Outcome|BioThrax - > 30 Years of Age|Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
167129|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
167130|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
167131|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
167132|NCT01491607|O1|Outcome|BioThrax - Days 63-100 Immunogenicity|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
167133|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
167134|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
167135|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
167136|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
167137|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
167138|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
167139|NCT01491607|O5|Outcome|BioThrax - > 30 Years of Age|Participants > 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
167158|NCT01491490|B1|Baseline|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
167159|NCT01491490|P2|Participant Flow|Placebo|Taken as 6 capsules, matched to taste and look like the active study medication.
167140|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
167141|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
167142|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
167143|NCT01491607|O1|Outcome|BioThrax - Day 70|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
167144|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
167145|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
167146|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
167147|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
167148|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
167149|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
167150|NCT01491607|O5|Outcome|BioThrax- > 30 Years of Age|Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
167151|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
167152|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
167153|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
167154|NCT01491607|O1|Outcome|BioThrax|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
168466|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
167162|NCT01491490|O1|Outcome|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
167163|NCT01491490|E2|Reported Event|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
167164|NCT01491490|E1|Reported Event|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
167165|NCT01491113|B6|Baseline|Total|Total of all reporting groups
167166|NCT01491113|B5|Baseline|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167167|NCT01491113|B4|Baseline|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167168|NCT01491113|B3|Baseline|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167169|NCT01491113|B2|Baseline|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167170|NCT01491113|B1|Baseline|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167171|NCT01491113|P5|Participant Flow|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167172|NCT01491113|P4|Participant Flow|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167173|NCT01491113|P3|Participant Flow|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167174|NCT01491113|P2|Participant Flow|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167350|NCT01491022|O1|Outcome|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
167304|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167305|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167175|NCT01491113|P1|Participant Flow|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167176|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetics (PK) analysis: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167177|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167178|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167179|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167180|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167181|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167182|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167351|NCT01491022|O2|Outcome|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
167183|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167184|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167185|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167186|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167187|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167188|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167189|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167190|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167191|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167192|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167193|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167298|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167299|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167194|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167195|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167196|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167197|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167198|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167199|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167200|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167201|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167202|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167203|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167204|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167300|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167301|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
168467|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
167205|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167206|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167207|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167208|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167209|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167210|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167211|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167212|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167213|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167214|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167215|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
168468|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
167216|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167217|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167218|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167219|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167220|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167221|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167222|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167223|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167224|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167225|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167226|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167302|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167303|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167227|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167228|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167229|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167230|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167231|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167232|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167233|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167234|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167235|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167236|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167247|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167349|NCT01491022|O2|Outcome|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
167237|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167238|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167239|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167240|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167241|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167242|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167243|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167244|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167245|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167246|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
192246|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
167248|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167249|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167250|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167251|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167252|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167253|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167254|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167255|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167256|NCT01491113|E5|Reported Event|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.
The 4-h Hemodialysis was scheduled as follows:
Dialysis: 44 h to 48 h after the first dose (Day 3)
Dialysis: 92 h to 96 h after the first dose (Day 5)
Dialysis: 140 h after the first dose (Day 7)
Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.
49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.
*Inflow blood, outflow blood, and dialysate fluid were collected."
167257|NCT01491113|E4|Reported Event|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
167258|NCT01491113|E3|Reported Event|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
167259|NCT01491113|E2|Reported Event|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
167260|NCT01491113|E1|Reported Event|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.
Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
167261|NCT01491035|B9|Baseline|Total|Total of all reporting groups
167262|NCT01491035|B8|Baseline|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167263|NCT01491035|B7|Baseline|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167264|NCT01491035|B6|Baseline|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167265|NCT01491035|B5|Baseline|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167266|NCT01491035|B4|Baseline|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167267|NCT01491035|B3|Baseline|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167268|NCT01491035|B2|Baseline|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167269|NCT01491035|B1|Baseline|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167270|NCT01491035|P8|Participant Flow|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167271|NCT01491035|P7|Participant Flow|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167272|NCT01491035|P6|Participant Flow|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167273|NCT01491035|P5|Participant Flow|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167274|NCT01491035|P4|Participant Flow|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167275|NCT01491035|P3|Participant Flow|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167276|NCT01491035|P2|Participant Flow|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167277|NCT01491035|P1|Participant Flow|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167278|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167279|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167280|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167281|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167282|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167283|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167284|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167285|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167286|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167287|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167288|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167289|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167290|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167291|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167292|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167293|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167294|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167295|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167296|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167297|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167306|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167307|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167308|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167309|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167310|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167311|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167312|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167313|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167314|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167315|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167316|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167317|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167318|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167319|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167320|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167321|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167322|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167323|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167324|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167325|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167326|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167327|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167328|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167329|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167330|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167331|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167332|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167333|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167334|NCT01491035|E8|Reported Event|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167335|NCT01491035|E7|Reported Event|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167336|NCT01491035|E6|Reported Event|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167337|NCT01491035|E5|Reported Event|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167338|NCT01491035|E4|Reported Event|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
167339|NCT01491035|E3|Reported Event|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
167340|NCT01491035|E2|Reported Event|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
167341|NCT01491035|E1|Reported Event|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
167342|NCT01491022|B3|Baseline|Total|Total of all reporting groups
167343|NCT01491022|B2|Baseline|Placebo Then Ampyra|Placebo for 4 weeks followed by 2 weeks washout followed by Ampyra 10 mg po bid for 4 weeks
167344|NCT01491022|B1|Baseline|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
167345|NCT01491022|P2|Participant Flow|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
167346|NCT01491022|P1|Participant Flow|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
167347|NCT01491022|O2|Outcome|Placebo|"placebo 4 weeks followed by Ampyra 10 mg po BID
placebo first, then Ampyra: placebo"
167348|NCT01491022|O1|Outcome|Ampyra|"Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks
Ampyra first, then Placebo: 10 mg po bid for 4 weeks followed by placebo 4 weeks."
167352|NCT01491022|O1|Outcome|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
167353|NCT01491022|O2|Outcome|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
167354|NCT01491022|O1|Outcome|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
167355|NCT01491022|O2|Outcome|Placebo|"placebo 4 weeks followed by Ampyra 10 mg po BID
placebo first, then Ampyra: placebo"
167356|NCT01491022|O1|Outcome|Ampyra|"Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks
Ampyra first, then Placebo: 10 mg po bid for 4 weeks followed by placebo 4 weeks."
167357|NCT01491022|O2|Outcome|Placebo|placebo: placebo
167358|NCT01491022|O1|Outcome|Ampyra|"Ampyra 10 mg po BID
Dalfampridine: 10 mg po bid for 4 weeks"
167359|NCT01491022|E2|Reported Event|Placebo|placebo: placebo
167360|NCT01491022|E1|Reported Event|Ampyra|"Ampyra 10 mg po BID
Dalfampridine: 10 mg po bid for 4 weeks"
167361|NCT01490931|B1|Baseline|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167362|NCT01490931|P1|Participant Flow|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167363|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167364|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167365|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167366|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167367|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167368|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167369|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167370|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167371|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167372|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167373|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167374|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167375|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167376|NCT01490931|E1|Reported Event|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.
Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
167377|NCT01490866|B1|Baseline|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.
FOLFOX/bevacizumab:
5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV
Maintenance:
- Axitinib: 5-mg tablets orally twice per day (PO BID)"
167378|NCT01490866|P1|Participant Flow|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.
FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):
5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
Bevacizumab: 5 mg/kg on Days 1 and 15 by IV
Maintenance:
- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
167379|NCT01490866|O2|Outcome|Axitinib|All patients who received at least one dose of axitinib
167380|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab|All patients who received at least one dose of FOLFOX/bevacizumab
167433|NCT01490632|P15|Participant Flow|Part C: Responder - High Dose to Placebo|Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.
168391|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox
Acipimox: 250 mg by mouth (PO) three times daily"
167381|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.
FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):
5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
Bevacizumab: 5 mg/kg on Days 1 and 15 by IV
Maintenance:
- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
167382|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.
FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):
5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
Bevacizumab: 5 mg/kg on Days 1 and 15 by IV
Maintenance:
- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
167383|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.
FOLFOX/bevacizumab:
5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV
Maintenance:
- Axitinib: 5-mg tablets orally twice per day (PO BID)"
167384|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.
FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):
5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;
Leucovorin: 400 mg/m2 given Days 1 and 15 by IV
Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV
Bevacizumab: 5 mg/kg on Days 1 and 15 by IV
Maintenance:
- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
167385|NCT01490866|E1|Reported Event|FOLFOX/Bevacizumab and Axitinib|
167386|NCT01490840|B3|Baseline|Total|Total of all reporting groups
167387|NCT01490840|B2|Baseline|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167388|NCT01490840|B1|Baseline|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167389|NCT01490840|P2|Participant Flow|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167390|NCT01490840|P1|Participant Flow|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167426|NCT01490632|B2|Baseline|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167427|NCT01490632|B1|Baseline|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167428|NCT01490632|P20|Participant Flow|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
168307|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
167391|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167392|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167393|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167394|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167395|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167396|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167397|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167398|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167429|NCT01490632|P19|Participant Flow|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167430|NCT01490632|P18|Participant Flow|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
192247|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
167399|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167400|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167401|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167402|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167403|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167404|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167405|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167406|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167431|NCT01490632|P17|Participant Flow|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167432|NCT01490632|P16|Participant Flow|Part C: Responder - High Dose to Low Dose|Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.
167407|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167408|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167409|NCT01490840|E2|Reported Event|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
167410|NCT01490840|E1|Reported Event|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
167411|NCT01490697|B3|Baseline|Total|Total of all reporting groups
167412|NCT01490697|B2|Baseline|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
167413|NCT01490697|B1|Baseline|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
167414|NCT01490697|P2|Participant Flow|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
167415|NCT01490697|P1|Participant Flow|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
167416|NCT01490697|O2|Outcome|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
167417|NCT01490697|O1|Outcome|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
167418|NCT01490697|O2|Outcome|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
167419|NCT01490697|O1|Outcome|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
167420|NCT01490697|E2|Reported Event|Mifepristone Plus d-Cycloserine (DCS)|DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
167421|NCT01490697|E1|Reported Event|Placebo Plus Placebo|Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
167422|NCT01490632|B6|Baseline|Total|Total of all reporting groups
167423|NCT01490632|B5|Baseline|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167424|NCT01490632|B4|Baseline|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
167425|NCT01490632|B3|Baseline|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
168469|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
167434|NCT01490632|P14|Participant Flow|Part C: Responder - Low Dose to ½ Low Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.
167435|NCT01490632|P13|Participant Flow|Part C: Responder - Low Dose to Placebo|Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.
167436|NCT01490632|P12|Participant Flow|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
167437|NCT01490632|P11|Participant Flow|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
167438|NCT01490632|P10|Participant Flow|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167439|NCT01490632|P9|Participant Flow|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
167440|NCT01490632|P8|Participant Flow|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167441|NCT01490632|P7|Participant Flow|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
167442|NCT01490632|P6|Participant Flow|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
167443|NCT01490632|P5|Participant Flow|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167444|NCT01490632|P4|Participant Flow|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
167445|NCT01490632|P3|Participant Flow|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167446|NCT01490632|P2|Participant Flow|Part A: Baricitinib 2 mg|Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167447|NCT01490632|P1|Participant Flow|Part A: Placebo|Placebo administered orally (PO) once daily (QD) for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167448|NCT01490632|O4|Outcome|Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167449|NCT01490632|O3|Outcome|Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
167450|NCT01490632|O2|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167451|NCT01490632|O1|Outcome|Baricitinib 2 mg|Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167452|NCT01490632|O4|Outcome|Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167453|NCT01490632|O3|Outcome|Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
167454|NCT01490632|O2|Outcome|Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167455|NCT01490632|O1|Outcome|Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167456|NCT01490632|O4|Outcome|Part C: Responder - High Dose to Low Dose|Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.
167457|NCT01490632|O3|Outcome|Part C: Responder - High Dose to Placebo|Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.
167458|NCT01490632|O2|Outcome|Part C: Responder - Low Dose to ½ Low Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.
167459|NCT01490632|O1|Outcome|Part C: Responder - Low Dose to Placebo|Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.
167460|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167461|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167462|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167463|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167464|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
167465|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
167466|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167467|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
167468|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
167469|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
167470|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
167471|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167472|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
167473|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167474|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167475|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167476|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167477|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167478|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167479|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167480|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
167481|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
167482|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167483|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
167484|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167485|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
167486|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
167487|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167488|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
167489|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167490|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167491|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167492|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167493|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167494|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167495|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167496|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
167497|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
167498|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167499|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
167500|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167501|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
167502|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
167503|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167504|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
167505|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167506|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks
192248|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
167890|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
167507|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167508|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167509|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167510|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167511|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167512|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
167513|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
167514|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167515|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
167516|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167517|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
167518|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
167519|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167520|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
167521|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167522|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167523|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167524|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167525|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167526|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167527|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167528|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
167529|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
167530|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167531|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
167532|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167533|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
167534|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
167535|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167536|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
167537|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167538|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167539|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167540|NCT01490632|O4|Outcome|Part D: Baricitinib 10 mg - Retreatment|Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167541|NCT01490632|O3|Outcome|Part D: Baricitinib 8 mg - Retreatment|Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167542|NCT01490632|O2|Outcome|Part D: Baricitinib 4 mg - Retreatment|Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167543|NCT01490632|O1|Outcome|Part D: Baricitinib 2 mg - Retreatment|Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
167544|NCT01490632|O7|Outcome|Part B: Placebo Extension|Placebo PO QD maintained on placebo PO QD.
167545|NCT01490632|O6|Outcome|Part B: Partial- and Non-responder - High Dose to High Dose|Baricitinib administered 8 mg or 10 mg PO QD.
167546|NCT01490632|O5|Outcome|Part B: Partial- and Non-responder - Low Dose to High Dose|Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167547|NCT01490632|O4|Outcome|Part B: Partial-responder - Low Dose to Low Dose|Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
167548|NCT01490632|O3|Outcome|Part B: Partial- and Non-responder - Placebo to High Dose|Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
167549|NCT01490632|O2|Outcome|Part B: Responder - High Dose|Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
167550|NCT01490632|O1|Outcome|Part B: Responder - Low Dose|Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
167551|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167552|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
167553|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167554|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167555|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167556|NCT01490632|O5|Outcome|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167557|NCT01490632|O4|Outcome|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
167558|NCT01490632|O3|Outcome|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167559|NCT01490632|O2|Outcome|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167560|NCT01490632|O1|Outcome|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167561|NCT01490632|E13|Reported Event|Follow-up: Ever Used Baricitinib|Participants in follow-up with exposure to any dose of baricitinib during study. No baricitinib received during follow-up.
167562|NCT01490632|E12|Reported Event|Follow-up: Always Placebo|Participants in follow-up with exposure to placebo only during the study. No placebo received during follow-up.
167563|NCT01490632|E11|Reported Event|Part D: All Baricitinib Doses|All participant dosages following baricitinib retreatment with Part B efficacious dose for 52 weeks.
167564|NCT01490632|E10|Reported Event|Part C: Baricitinib|All baricitinib participant groups after study drug re-randomized to various doses.
167565|NCT01490632|E9|Reported Event|Part C: Placebo|All placebo participant groups after study drug re-randomized.
167566|NCT01490632|E8|Reported Event|Part B: High Dose|"All participants in the following groups (as described in the Participant Flow):
Responder High Dose
Partial and Non-responder Placebo to High Dose
Partial and Non-responder Low Dose to High Dose
Partial and Non-responder High Dose to High Dose"
167567|NCT01490632|E7|Reported Event|Part B: Low Dose|"All participants in the following groups (as described in the Participant Flow):
Responder Low Dose
Partial Responder Low Dose to Low Dose groups."
167568|NCT01490632|E6|Reported Event|Part B: Placebo|Placebo PO QD maintained on placebo PO QD.
167569|NCT01490632|E5|Reported Event|Part A: Baricitinib 10 mg|Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
167570|NCT01490632|E4|Reported Event|Part A: Baricitinib 8 mg|Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
167571|NCT01490632|E3|Reported Event|Part A: Baricitinib 4 mg|Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167572|NCT01490632|E2|Reported Event|Part A: Baricitinib 2 mg|Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167573|NCT01490632|E1|Reported Event|Part A: Placebo|Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
167574|NCT01490294|B5|Baseline|Total|Total of all reporting groups
167575|NCT01490294|B4|Baseline|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167576|NCT01490294|B3|Baseline|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167577|NCT01490294|B2|Baseline|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
192249|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
167578|NCT01490294|B1|Baseline|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167579|NCT01490294|P4|Participant Flow|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167580|NCT01490294|P3|Participant Flow|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167581|NCT01490294|P2|Participant Flow|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167582|NCT01490294|P1|Participant Flow|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167583|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167584|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167585|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167586|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167587|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167588|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167589|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167590|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167591|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167592|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167593|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167594|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167595|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167596|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167597|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167598|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167599|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167600|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167601|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167602|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167603|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167604|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167605|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167606|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167607|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167608|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167609|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167610|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167611|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167612|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167613|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167614|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167615|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167616|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167617|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
192250|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
167618|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167619|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167620|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167621|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167622|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167623|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167624|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167625|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167626|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167627|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167628|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167629|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167630|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167631|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167632|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167633|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167634|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167635|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167636|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167637|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
192251|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
167638|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167639|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167640|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167641|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167642|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167643|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167644|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167645|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167646|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167647|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167648|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167649|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167650|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167651|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167652|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167653|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167654|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167655|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167656|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167657|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
192252|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
167658|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167659|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167660|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167661|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167662|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167663|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167664|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167665|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167666|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167667|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167668|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167669|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167670|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167671|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167672|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167673|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167674|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167675|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167676|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167677|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
192253|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
167678|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167679|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167680|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167681|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167682|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167683|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167684|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167685|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167686|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167687|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167688|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167689|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167690|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167691|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167692|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167693|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167694|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167695|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167696|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167697|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
192254|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
167698|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167699|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167700|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167701|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167702|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167703|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167704|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167705|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167706|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167707|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167708|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167709|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167710|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167711|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167712|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167713|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167714|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167715|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167716|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167717|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
192255|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
167718|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167719|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167720|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167721|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167722|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167723|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167724|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167725|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167726|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167727|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167728|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167729|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167730|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167731|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167732|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167733|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167734|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167735|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167736|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167737|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
192256|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
167738|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167739|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167740|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167741|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167742|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167743|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167744|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167745|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167746|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167747|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167748|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167749|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167750|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167751|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167752|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167753|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167754|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167755|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167756|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167757|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
192348|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
167758|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167759|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167760|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167761|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167762|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167763|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167764|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167765|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167766|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167767|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167768|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167769|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167770|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167771|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167772|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167773|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167774|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167775|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167776|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167777|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
192349|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
167778|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167779|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167780|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167781|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167782|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167783|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167784|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167785|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167786|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167787|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167788|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167789|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167790|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167791|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167792|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167793|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167794|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167795|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167796|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167797|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
192350|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
167798|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167799|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167800|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167801|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167802|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167803|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167804|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167805|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167806|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167807|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167808|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167809|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167810|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167811|NCT01490294|E4|Reported Event|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167812|NCT01490294|E3|Reported Event|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167813|NCT01490294|E2|Reported Event|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167814|NCT01490294|E1|Reported Event|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
167815|NCT01490190|B1|Baseline|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
167816|NCT01490190|P1|Participant Flow|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
167817|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167818|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167819|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
192351|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
167820|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167821|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167822|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167823|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167824|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167825|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167826|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167827|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167828|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167829|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167830|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167831|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167832|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167833|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167834|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
167835|NCT01490190|E1|Reported Event|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
167836|NCT01490125|B1|Baseline|All Participants|All participants who entered the study and were randomized to any of the 3 treatment combinations: QVA149 plus placebo to tiotropium; tiotropium plus placebo to QVA149 or placebo to QVA149 plus placebo to tiotropium.
167837|NCT01490125|P6|Participant Flow|Tiotropium + Placebo +QVA149|Participants were randomized to sequence tiotropium + placebo + QVA149
167838|NCT01490125|P5|Participant Flow|Tiotropium + QVA149+ Placebo|Participants were randomized to sequence tiotropium + QVA149 + placebo
167839|NCT01490125|P4|Participant Flow|Placebo+ Tiotropium + QVA149|Participants were randomized to sequence placebo + tiotropium + QVA149
167840|NCT01490125|P3|Participant Flow|Placebo + QVA149 + Tiotropium|Participants were randomized to sequence placebo + QVA149 + tiotropium
167841|NCT01490125|P2|Participant Flow|QVA149+ Tiotropium+ Placebo|Participants were randomized to sequence QVA149 + tiotropium + placebo.
167842|NCT01490125|P1|Participant Flow|QVA149+ Placebo+ Tiotropium|Participants were randomized to sequence QVA149 + placebo + tiotropium.
167843|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167844|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167845|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167846|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167847|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167848|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167849|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167850|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167851|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167852|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
192352|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
167853|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167854|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167855|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167856|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167857|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167858|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167859|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167860|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167861|NCT01490125|E3|Reported Event|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167862|NCT01490125|E2|Reported Event|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167863|NCT01490125|E1|Reported Event|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
167864|NCT01490086|B6|Baseline|Total|Total of all reporting groups
167865|NCT01490086|B5|Baseline|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
167866|NCT01490086|B4|Baseline|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
167867|NCT01490086|B3|Baseline|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
167868|NCT01490086|B2|Baseline|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
167869|NCT01490086|B1|Baseline|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
167870|NCT01490086|P5|Participant Flow|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
167871|NCT01490086|P4|Participant Flow|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
167872|NCT01490086|P3|Participant Flow|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
167873|NCT01490086|P2|Participant Flow|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
167874|NCT01490086|P1|Participant Flow|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
167875|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
167876|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
167877|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
167878|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
167879|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
167880|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
167881|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
167882|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
167883|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
167884|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
167885|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
167886|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
167887|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
167888|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
167889|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
167891|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
167892|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
167893|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
167894|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
167895|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
167896|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
167897|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
167898|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
167899|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
167900|NCT01490086|E5|Reported Event|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
167901|NCT01490086|E4|Reported Event|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
167902|NCT01490086|E3|Reported Event|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
167903|NCT01490086|E2|Reported Event|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
167904|NCT01490086|E1|Reported Event|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
167905|NCT01490060|B3|Baseline|Total|Total of all reporting groups
167906|NCT01490060|B2|Baseline|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
167907|NCT01490060|B1|Baseline|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
167908|NCT01490060|P4|Participant Flow|Arm B: Two Doses, Group 2|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
167909|NCT01490060|P3|Participant Flow|Arm B: Two Doses, Group 1|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
167910|NCT01490060|P2|Participant Flow|Arm A: Single Dose, Group 2|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
167911|NCT01490060|P1|Participant Flow|Arm A: Single Dose, Group 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
167912|NCT01490060|O3|Outcome|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
167980|NCT01489826|B2|Baseline|Dexanabinol Dose Escalation - Cohort 2|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
168390|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.
Placebo: 0 mg by mouth (PO) three times daily"
167913|NCT01490060|O2|Outcome|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
167914|NCT01490060|O1|Outcome|Control Cycle (Arm A/Arm B)|Control cycle without fosaprepitant.
167915|NCT01490060|E3|Reported Event|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
167916|NCT01490060|E2|Reported Event|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
167917|NCT01490060|E1|Reported Event|Control Cycle (Arm A/Arm B)|Control cycle without fosaprepitant.
167918|NCT01489956|B3|Baseline|Total|Total of all reporting groups
167919|NCT01489956|B2|Baseline|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167920|NCT01489956|B1|Baseline|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167921|NCT01489956|P3|Participant Flow|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167922|NCT01489956|P2|Participant Flow|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167923|NCT01489956|P1|Participant Flow|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167924|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167925|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167926|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167927|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167928|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167929|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167930|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167931|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167932|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167933|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
168387|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox
Acipimox: 250 mg by mouth (PO) three times daily"
167934|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167935|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167936|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167937|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167938|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167939|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167940|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167941|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167942|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167943|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167944|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167945|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167946|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167947|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167948|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167949|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167950|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167951|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167981|NCT01489826|B1|Baseline|Dexanabinol Dose Escalation - Cohort 1|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
168470|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
167952|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167953|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167954|NCT01489956|E3|Reported Event|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
167955|NCT01489956|E2|Reported Event|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
167956|NCT01489956|E1|Reported Event|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
167957|NCT01489891|B3|Baseline|Total|Total of all reporting groups
167958|NCT01489891|B2|Baseline|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
167959|NCT01489891|B1|Baseline|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD
Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
167960|NCT01489891|P2|Participant Flow|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
167961|NCT01489891|P1|Participant Flow|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)
Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
167962|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
167963|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD
Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
167964|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
167965|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD
Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
167966|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
167967|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD
Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
167968|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
167969|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD
Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
167970|NCT01489891|E2|Reported Event|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
167971|NCT01489891|E1|Reported Event|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD
Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
167972|NCT01489826|B10|Baseline|Total|Total of all reporting groups
167973|NCT01489826|B9|Baseline|Dexanabinol Expansion Phase|Open label, expansion phase to assess pharmacodynamics of dexanabinol in patients with advanced tumours at the MTD/MAD (30 mg/kg)
167974|NCT01489826|B8|Baseline|Dexanabinol Dose Escalation - Cohort 8|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
167975|NCT01489826|B7|Baseline|Dexanabinol Dose Escalation - Cohort 7|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
167976|NCT01489826|B6|Baseline|Dexanabinol Dose Escalation - Cohort 6|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
167977|NCT01489826|B5|Baseline|Dexanabinol Dose Escalation - Cohort 5|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
167978|NCT01489826|B4|Baseline|Dexanabinol Dose Escalation - Cohort 4|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
167979|NCT01489826|B3|Baseline|Dexanabinol Dose Escalation - Cohort 3|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
192353|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
167982|NCT01489826|P9|Participant Flow|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167983|NCT01489826|P8|Participant Flow|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167984|NCT01489826|P7|Participant Flow|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167985|NCT01489826|P6|Participant Flow|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167986|NCT01489826|P5|Participant Flow|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167987|NCT01489826|P4|Participant Flow|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167988|NCT01489826|P3|Participant Flow|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167989|NCT01489826|P2|Participant Flow|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167990|NCT01489826|P1|Participant Flow|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167991|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167992|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167993|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167994|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167995|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167996|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167997|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167998|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
167999|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168000|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168001|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168002|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168003|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168004|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168005|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168006|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168007|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168008|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168009|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168010|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168011|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168012|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168013|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168014|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168015|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168016|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168017|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168018|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168019|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168020|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168021|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168022|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168023|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168024|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168025|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168254|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168026|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168027|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168028|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168029|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168030|NCT01489826|O6|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168031|NCT01489826|O5|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168032|NCT01489826|O4|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168033|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168034|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168035|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168036|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168037|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168038|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168039|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168040|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168041|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168042|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168043|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168044|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168045|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168046|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168047|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168048|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168049|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168050|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168051|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168052|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168053|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168054|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168055|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168056|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168057|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168058|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168059|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168060|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168061|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168062|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168063|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168064|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168065|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168066|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168067|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168068|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168069|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168070|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168071|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168072|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168073|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168074|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168075|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168076|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168077|NCT01489826|E9|Reported Event|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168078|NCT01489826|E8|Reported Event|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168079|NCT01489826|E7|Reported Event|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168080|NCT01489826|E6|Reported Event|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168081|NCT01489826|E5|Reported Event|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168082|NCT01489826|E4|Reported Event|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168083|NCT01489826|E3|Reported Event|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168084|NCT01489826|E2|Reported Event|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168085|NCT01489826|E1|Reported Event|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
168086|NCT01489670|B1|Baseline|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
168087|NCT01489670|P1|Participant Flow|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
168088|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
168089|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
168090|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
168091|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
168092|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
168093|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
168094|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
168095|NCT01489670|E1|Reported Event|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
168096|NCT01489527|B3|Baseline|Total|Total of all reporting groups
168097|NCT01489527|B2|Baseline|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
168098|NCT01489527|B1|Baseline|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
168099|NCT01489527|P2|Participant Flow|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
168100|NCT01489527|P1|Participant Flow|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
168101|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
168102|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
168103|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
168104|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
168105|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
168106|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
168107|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
168108|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
168109|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
168110|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
168111|NCT01489527|E2|Reported Event|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
168112|NCT01489527|E1|Reported Event|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
168113|NCT01489358|B4|Baseline|Total|Total of all reporting groups
168114|NCT01489358|B3|Baseline|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168115|NCT01489358|B2|Baseline|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168116|NCT01489358|B1|Baseline|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168117|NCT01489358|P3|Participant Flow|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168118|NCT01489358|P2|Participant Flow|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168119|NCT01489358|P1|Participant Flow|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168120|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168121|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168122|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168123|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168124|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168125|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168126|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168127|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168128|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168129|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168130|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168131|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168132|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168133|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168134|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168135|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168136|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168137|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168138|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168139|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168140|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168141|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168142|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168143|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168144|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168145|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168146|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168147|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168148|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168149|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168150|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168151|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168269|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168152|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168153|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168154|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168155|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168156|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168157|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168158|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168159|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168160|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168161|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168162|NCT01489358|E3|Reported Event|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168163|NCT01489358|E2|Reported Event|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168164|NCT01489358|E1|Reported Event|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
168165|NCT01489254|B4|Baseline|Total|Total of all reporting groups
168166|NCT01489254|B3|Baseline|Placebo|Placebo (daily) for 9 months
168167|NCT01489254|B2|Baseline|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
168168|NCT01489254|B1|Baseline|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
168169|NCT01489254|P4|Participant Flow|Extension Glatiramer 20 mg|Glatiramer acetate (GTR) 20 mg daily for 15 months, open-label extension
168170|NCT01489254|P3|Participant Flow|Placebo|Placebo (daily) for 9 months
168171|NCT01489254|P2|Participant Flow|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
168172|NCT01489254|P1|Participant Flow|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
168173|NCT01489254|O3|Outcome|Placebo|Placebo (daily) for 9 months
168174|NCT01489254|O2|Outcome|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
168175|NCT01489254|O1|Outcome|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
168176|NCT01489254|E4|Reported Event|Extension Glatiramer 20 mg|Glatiramer acetate (GTR) 20 mg daily for 15 months, open-label extension
168177|NCT01489254|E3|Reported Event|Placebo|Placebo (daily) for 9 months, double-blind
168178|NCT01489254|E2|Reported Event|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months, double-blind
168179|NCT01489254|E1|Reported Event|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months, double-blind
168180|NCT01489189|B3|Baseline|Total|Total of all reporting groups
168181|NCT01489189|B2|Baseline|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168182|NCT01489189|B1|Baseline|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168183|NCT01489189|P2|Participant Flow|Prompt PRP|"Panretinal Photocoagulation (PRP). PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168184|NCT01489189|P1|Participant Flow|Anti-VEGF+Deferred PRP|"Anti vascular endothelial growth factor (Anti-VEGF). Panretinal photocoagulation (PRP). Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168185|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168186|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168187|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168188|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168300|NCT01488877|P2|Participant Flow|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
168189|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168190|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168191|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168192|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168193|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168194|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168195|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168196|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168197|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168198|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168199|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168200|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168201|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168202|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168203|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168204|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168205|NCT01489189|E3|Reported Event|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
168206|NCT01489189|E2|Reported Event|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
168207|NCT01489189|E1|Reported Event|Bilateral Participants|Participants with one eye enrolled in each arm of the study.
168208|NCT01488994|B3|Baseline|Total|Total of all reporting groups
168209|NCT01488994|B2|Baseline|Pediatric Participants 6 to <12 Years of Age|Pediatric participants 6 to <12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168301|NCT01488877|P1|Participant Flow|PF-03882845 Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
168302|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
168471|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
168210|NCT01488994|B1|Baseline|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168211|NCT01488994|P2|Participant Flow|Pediatric Participants 6 to <12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168212|NCT01488994|P1|Participant Flow|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168213|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168214|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168215|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168216|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168217|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168218|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168219|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168220|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168221|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168222|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168223|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
192354|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
168224|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168225|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168226|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168227|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168228|NCT01488994|O1|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168229|NCT01488994|O1|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168230|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168231|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168232|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168233|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168234|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168235|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168236|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168237|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168238|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168239|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168303|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
168304|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
168240|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168241|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168242|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168243|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168244|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168245|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168246|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168247|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168248|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168249|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168250|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168251|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168252|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168253|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168472|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
168255|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168256|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168257|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168258|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168259|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168260|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168261|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168262|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168263|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168264|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168265|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168266|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168267|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168268|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168473|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
168270|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168271|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168272|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
168273|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168274|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168275|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
168276|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168277|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168278|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
168279|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168280|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168281|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
168282|NCT01488994|O2|Outcome|BAX326 6 to <12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168305|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
168306|NCT01488877|O1|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
192355|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
168283|NCT01488994|O1|Outcome|BAX326 < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168284|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
168285|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168286|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168287|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
168288|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168289|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168290|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
168291|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168292|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168293|NCT01488994|O1|Outcome|Overall Study Arm|No participants
168294|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168295|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168296|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
168297|NCT01488994|E1|Reported Event|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
168298|NCT01488877|B1|Baseline|Entire Study Population|All participants who were enrolled in this study.
168299|NCT01488877|P3|Participant Flow|Spironolactone Placebo|Similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
168308|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
168309|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
168310|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
168311|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
168312|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
168313|NCT01488877|E2|Reported Event|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
168314|NCT01488877|E1|Reported Event|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
168315|NCT01488578|B1|Baseline|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
168316|NCT01488578|P1|Participant Flow|Tolterodine Tartrate|Participants taking Tolterodine tartrate.
168317|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
168318|NCT01488578|O2|Outcome|Without Previous Treatment|Participants without previous treatment of OAB who took tolterodine according to Japanese Package Insert.
168319|NCT01488578|O1|Outcome|With Previous Treatment|Participants with previous treatment of OAB who took tolterodine according to Japanese Package Insert.
168320|NCT01488578|O3|Outcome|>= 5 Episodes|Participants with >= 5 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
168321|NCT01488578|O2|Outcome|3 to 4 Episodes|Participants with 3 or 4 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
168322|NCT01488578|O1|Outcome|1 to 2 Episodes|Participants with 1 or 2 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
168323|NCT01488578|O4|Outcome|>= 3 Urinations|Participants with >= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
168324|NCT01488578|O3|Outcome|2 Urinations|Participants with 2 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
168325|NCT01488578|O2|Outcome|1 Urination|Participants with 1 time urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
168326|NCT01488578|O1|Outcome|No Urination|Participants with no urination who took tolterodine according to Japanese Package Insert.
168327|NCT01488578|O2|Outcome|Without Urinary Urgency|Participants without urinary urgency who took tolterodine according to Japanese Package Insert.
168328|NCT01488578|O1|Outcome|With Urinary Urgency|Participants with urinary urgency who took tolterodine according to Japanese Package Insert.
168329|NCT01488578|O3|Outcome|Severe|Participants with severe OAB who took tolterodine according to Japanese Package Insert.
168330|NCT01488578|O2|Outcome|Moderate|Participants with moderate OAB who took tolterodine according to Japanese Package Insert.
168331|NCT01488578|O1|Outcome|Mild|Participants with mild OAB who took tolterodine according to Japanese Package Insert.
168332|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
168333|NCT01488578|O2|Outcome|Without BPH|Participants without complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert.
168334|NCT01488578|O1|Outcome|With BPH|Participants with complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert.
168335|NCT01488578|O2|Outcome|>=65 Years|Participants with >= 65 years who took tolterodine according to Japanese Package Insert.
168336|NCT01488578|O1|Outcome|<65 Years|Participants with < 65 years who took tolterodine according to Japanese Package Insert.
168337|NCT01488578|O2|Outcome|Without Complications|Participants without complications who took tolterodine according to Japanese Package Insert.
168338|NCT01488578|O1|Outcome|With Complications|Participants with complications who took tolterodine according to Japanese Package Insert.
168339|NCT01488578|O2|Outcome|Female|Female participants who took tolterodine according to Japanese Package Insert.
168340|NCT01488578|O1|Outcome|Male|Male participants who took tolterodine according to Japanese Package Insert.
168341|NCT01488578|O2|Outcome|Without Non-drug Therapies|Participants without non-drug therapies who took tolterodine according to Japanese Package Insert.
168342|NCT01488578|O1|Outcome|With Non-drug Therapies|Participants with non-drug therapies who took tolterodine according to Japanese Package Insert.
168343|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
168344|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
168345|NCT01488578|O2|Outcome|Without Concomitant Drugs|Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.
168346|NCT01488578|O1|Outcome|With Concomitant Drugs|Participants with concomitant drugs who took tolterodine according to Japanese Package Insert.
168347|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
168348|NCT01488578|E1|Reported Event|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
168349|NCT01488487|B1|Baseline|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.
Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.
Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
168388|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.
Placebo: 0 mg by mouth (PO) three times daily"
168389|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox
Acipimox: 250 mg by mouth (PO) three times daily"
168350|NCT01488487|P1|Participant Flow|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.
Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.
Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
168351|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.
Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.
Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
168352|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.
Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.
Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
168353|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.
Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.
Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
168354|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.
Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.
Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
168355|NCT01488487|E1|Reported Event|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.
Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.
Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
168356|NCT01488448|B3|Baseline|Total|Total of all reporting groups
168357|NCT01488448|B2|Baseline|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
168358|NCT01488448|B1|Baseline|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
168359|NCT01488448|P2|Participant Flow|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
168360|NCT01488448|P1|Participant Flow|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
168361|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
168362|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
168363|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
168364|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
168365|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
168366|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
168367|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
168368|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
168369|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
168370|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
168371|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
168372|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
168373|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
168374|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
168375|NCT01488448|O2|Outcome|Nebulized Normal Saline|"4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
0.9% sodium chloride: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge"
168376|NCT01488448|O1|Outcome|Nebulized Hypertonic Saline|"4mL nebulized 3% sodium chloride every 4 hours until discharge
3% sodium chloride: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge"
168377|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
168378|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
168379|NCT01488448|E2|Reported Event|Normal Saline|4mL nebulized 0.9% sodium chloride every 4 hours until discharge
168380|NCT01488448|E1|Reported Event|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
168381|NCT01488409|B3|Baseline|Total|Total of all reporting groups
168382|NCT01488409|B2|Baseline|Placebo|"Treatment with Placebo control.
Placebo: 0 mg by mouth (PO) three times daily"
168383|NCT01488409|B1|Baseline|Acipimox|"Treatment with the study drug Acipimox
Acipimox: 250 mg by mouth (PO) three times daily"
168384|NCT01488409|P2|Participant Flow|Placebo|"Treatment with Placebo control.
Placebo: 0 mg by mouth (PO) three times daily"
168385|NCT01488409|P1|Participant Flow|Acipimox|"Treatment with the study drug Acipimox
Acipimox: 250 mg by mouth (PO) three times daily"
168386|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.
Placebo: 0 mg by mouth (PO) three times daily"
168392|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.
Placebo: 0 mg by mouth (PO) three times daily"
168393|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox
Acipimox: 250 mg by mouth (PO) three times daily"
168394|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.
Placebo: 0 mg by mouth (PO) three times daily"
168395|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox
Acipimox: 250 mg by mouth (PO) three times daily"
168396|NCT01488409|E2|Reported Event|Placebo|"Treatment with Placebo control.
Placebo: 0 mg by mouth (PO) three times daily"
168397|NCT01488409|E1|Reported Event|Acipimox|"Treatment with the study drug Acipimox
Acipimox: 250 mg by mouth (PO) three times daily"
168398|NCT01488370|B4|Baseline|Total|Total of all reporting groups
168399|NCT01488370|B3|Baseline|Standard Laryngoscope|"A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation"
168400|NCT01488370|B2|Baseline|Storz|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168401|NCT01488370|B1|Baseline|Glidescope|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168402|NCT01488370|P3|Participant Flow|Standard Laryngoscope|"A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation"
168403|NCT01488370|P2|Participant Flow|Storz|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168404|NCT01488370|P1|Participant Flow|Glidescope|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168405|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation"
168406|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168407|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168408|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation"
168409|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168410|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168411|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation"
168412|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168413|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168414|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation"
168415|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168416|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168417|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation"
168418|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168419|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168420|NCT01488370|E3|Reported Event|Standard Laryngoscope|"A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation"
168421|NCT01488370|E2|Reported Event|Storz|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168422|NCT01488370|E1|Reported Event|Glidescope|"A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation"
168423|NCT01488188|B3|Baseline|Total|Total of all reporting groups
168424|NCT01488188|B2|Baseline|Influenza Vaccine-Nasal|"Nasal administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
168425|NCT01488188|B1|Baseline|Influenza Vaccine -Sublingual|"Sublingual administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
168426|NCT01488188|P2|Participant Flow|Influenza Vaccine-Nasal|"Nasal administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
168427|NCT01488188|P1|Participant Flow|Influenza Vaccine -Sublingual|"Sublingual administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
168428|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
168429|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
168430|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
168431|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
168432|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
168433|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
168434|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
168435|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
168436|NCT01488188|E2|Reported Event|Influenza Vaccine-Nasal|"Nasal administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
168437|NCT01488188|E1|Reported Event|Influenza Vaccine -Sublingual|"Sublingual administration
Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
168451|NCT01488071|P2|Participant Flow|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
168452|NCT01488071|P1|Participant Flow|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
168453|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
168474|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
168475|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
168438|NCT01488097|B1|Baseline|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
168439|NCT01488097|P1|Participant Flow|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
168440|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
168441|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
168442|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
168443|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
168444|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
168445|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
168446|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
168447|NCT01488097|E1|Reported Event|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
168448|NCT01488071|B3|Baseline|Total|Total of all reporting groups
168449|NCT01488071|B2|Baseline|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
168450|NCT01488071|B1|Baseline|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
168477|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
168478|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
168479|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
168480|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
168481|NCT01488071|E2|Reported Event|Agomelatine|
168482|NCT01488071|E1|Reported Event|Vortioxetine|
168483|NCT01488019|B3|Baseline|Total|Total of all reporting groups
168484|NCT01488019|B2|Baseline|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168485|NCT01488019|B1|Baseline|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20mcg/2 mL, twice daily nebulization for 52 weeks"
168486|NCT01488019|P2|Participant Flow|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168487|NCT01488019|P1|Participant Flow|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168488|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168489|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168490|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168491|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168492|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168493|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168494|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist-Placebo: Placebo vehicle, 2mL, twice daily for 52 weeks"
168495|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist, nebulization, COPD: Perforomist, 20 mcg/2 mL, twice daily for 52 weeks"
168496|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168497|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168498|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168499|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168500|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168501|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168502|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168503|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168504|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168505|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168506|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168507|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168508|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168509|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168510|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168511|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168512|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168513|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168514|NCT01488019|O2|Outcome|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168515|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168516|NCT01488019|E2|Reported Event|Matching Placebo|"Placebo
Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
168517|NCT01488019|E1|Reported Event|Perforomist Inhalation Solution|"Active
Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
168518|NCT01487954|B3|Baseline|Total|Total of all reporting groups
168519|NCT01487954|B2|Baseline|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy
distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
168553|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil
Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
192356|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
168554|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil
Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
168520|NCT01487954|B1|Baseline|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
168521|NCT01487954|P2|Participant Flow|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy
distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
168522|NCT01487954|P1|Participant Flow|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
168523|NCT01487954|O2|Outcome|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy
distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
168524|NCT01487954|O1|Outcome|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
168525|NCT01487954|O2|Outcome|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy
distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
168526|NCT01487954|O1|Outcome|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
168527|NCT01487954|E2|Reported Event|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy
distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
168528|NCT01487954|E1|Reported Event|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
168529|NCT01487863|B3|Baseline|Total|Total of all reporting groups
168530|NCT01487863|B2|Baseline|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred.
sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
168531|NCT01487863|B1|Baseline|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred.
sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
168532|NCT01487863|P2|Participant Flow|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.
sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
168533|NCT01487863|P1|Participant Flow|Concurrent Arm|"Subjects received sipuleucel-T with concurrent abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.
sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
168534|NCT01487863|O2|Outcome|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.
sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
168535|NCT01487863|O1|Outcome|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.
sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
168536|NCT01487863|E2|Reported Event|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.
sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
168537|NCT01487863|E1|Reported Event|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.
sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
168538|NCT01487668|B3|Baseline|Total|Total of all reporting groups
168539|NCT01487668|B2|Baseline|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
168540|NCT01487668|B1|Baseline|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
168541|NCT01487668|P2|Participant Flow|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
168542|NCT01487668|P1|Participant Flow|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
168543|NCT01487668|O2|Outcome|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages
168544|NCT01487668|O1|Outcome|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
168545|NCT01487668|O2|Outcome|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
168546|NCT01487668|O1|Outcome|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
168547|NCT01487668|E2|Reported Event|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
168548|NCT01487668|E1|Reported Event|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
168549|NCT01487577|B1|Baseline|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil
Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
168550|NCT01487577|P1|Participant Flow|Mycophenolate Mofetil|Pharmacokinetics-based targeting of Mycophenolate mofetil
168551|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil
Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
168552|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil
Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
168555|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil
Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
168556|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil
Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
168557|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil
Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
168558|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil
Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
168559|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil
Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
168560|NCT01487577|E1|Reported Event|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil
Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
168561|NCT01487525|B3|Baseline|Total|Total of all reporting groups
168562|NCT01487525|B2|Baseline|PBFR+|"strength training exercise with partial blood flow restriction
double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
168563|NCT01487525|B1|Baseline|PBFR-|"strength training exercise without partial blood flow restriction
double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
168564|NCT01487525|P2|Participant Flow|PBFR+|"strength training exercise with partial blood flow restriction
double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
168565|NCT01487525|P1|Participant Flow|PBFR-|"strength training exercise without partial blood flow restriction
double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
168566|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction
double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
168567|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction
double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
168568|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction
double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
168569|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction
double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
168570|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction
double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
168571|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction
double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
168572|NCT01487525|E2|Reported Event|PBFR+|"strength training exercise with partial blood flow restriction
double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
168573|NCT01487525|E1|Reported Event|PBFR-|"strength training exercise without partial blood flow restriction
double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
168574|NCT01487499|B1|Baseline|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.
Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
168575|NCT01487499|P1|Participant Flow|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.
Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
168576|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.
Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
168577|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.
Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
168578|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.
Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
168579|NCT01487499|E1|Reported Event|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.
Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
168580|NCT01486966|B3|Baseline|Total|Total of all reporting groups
168581|NCT01486966|B2|Baseline|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168582|NCT01486966|B1|Baseline|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168619|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
168583|NCT01486966|P2|Participant Flow|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168584|NCT01486966|P1|Participant Flow|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168585|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168586|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168587|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168588|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168589|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168590|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168591|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168592|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168593|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168594|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168595|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168596|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168597|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168598|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168599|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168600|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168601|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168602|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168603|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168604|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168605|NCT01486966|E2|Reported Event|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168606|NCT01486966|E1|Reported Event|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
168607|NCT01486927|B1|Baseline|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover PK analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs. In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
168608|NCT01486927|P1|Participant Flow|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover pharmacokinetic [PK] analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 exposure days (EDs). In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
168609|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
168610|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
168611|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
168612|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
168613|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
168614|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
168615|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
168616|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
168617|NCT01486927|O3|Outcome|rVIII-SingleChain|The Efficacy population consisted of all subjects who received at least one dose of rVIII-SingleChain as part of either routine prophylaxis treatment or on-demand treatment during Parts 2 or 3 of the study. There were 173 subjects in the Efficacy population.
168618|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
168639|NCT01486758|B2|Baseline|Placebo|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168620|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
168621|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
168622|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
168623|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
168624|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
168625|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
168626|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
168627|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
168628|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
168629|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
168630|NCT01486927|O1|Outcome|rVIII-SingleChain Surgical|The rVIII-SingleChain Surgical group included all subjects enrolled in the surgical sub-study who received at least 1 dose of rVIII-SingleChain during the surgical sub-study. There were 13 subjects in the rVIII-SingleChain Surgical group.
168631|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
168632|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
168633|NCT01486927|O1|Outcome|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover PK analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs. In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
168634|NCT01486927|O3|Outcome|rVIII-SingleChain|The Efficacy population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either routine prophylaxis treatment or on-demand treatment during Parts 2 or 3 of the study. There were 173 subjects in the Efficacy population.
168635|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
168636|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
168637|NCT01486927|E1|Reported Event|Safety Population|The Safety Population comprised all subjects treated with rVIII-SingleChain.
168638|NCT01486758|B3|Baseline|Total|Total of all reporting groups
168705|NCT01486615|E1|Reported Event|Melatonin|premedication 1-2 hour prior to anesthesia
168640|NCT01486758|B1|Baseline|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168641|NCT01486758|P2|Participant Flow|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168643|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168644|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
168645|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168646|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
168647|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168648|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
168649|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168650|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
168651|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168652|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
168653|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168654|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
168655|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168656|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
168657|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168658|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days
168659|NCT01486758|E2|Reported Event|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
168660|NCT01486758|E1|Reported Event|Placebo|Placebo for 14 days.
168661|NCT01486615|B5|Baseline|Total|Total of all reporting groups
168662|NCT01486615|B4|Baseline|Placebo|premedication 1-2 hr prior to anesthesia
168663|NCT01486615|B3|Baseline|Alprazolam|premedication 1-2 hr prior to anesthesia
168664|NCT01486615|B2|Baseline|Melatonin and Alprazolam|premedicated 1-2 hrs prior to anesthesia
168665|NCT01486615|B1|Baseline|Melatonin|premedication 1-2 hour prior to anesthesia
168666|NCT01486615|P4|Participant Flow|Placebo|Oral premedication with a similar looking placebo tablet 1-2 hr prior to anesthesia
168667|NCT01486615|P3|Participant Flow|Alprazolam|Oral premedication with 0.5 mg alprazolam (Alprax) 1-2 hr prior to anesthesia
168668|NCT01486615|P2|Participant Flow|Melatonin and Alprazolam|Oral premedication with a 3 mg melatonin and 0.5 mg alprazolam combination tablet (Stressnil) 1-2 hrs prior to anesthesia
168669|NCT01486615|P1|Participant Flow|Melatonin|Oral premedication with 3 mg melatonin tablet (Meloset) 1-2 hour prior to anesthesia
168670|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
168671|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
168672|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
168673|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
168674|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
168675|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
168676|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
168677|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
168678|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
168679|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
168680|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
168681|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
168682|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
168683|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
168684|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
168685|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
168686|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
168687|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
168688|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
168689|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
168690|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
168691|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
168692|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
168693|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
168694|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
168695|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
168696|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
168697|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
168698|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
168699|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
168700|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
168701|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
168702|NCT01486615|E4|Reported Event|Placebo|premedication 1-2 hr prior to anesthesia
168703|NCT01486615|E3|Reported Event|Alprazolam|premedication 1-2 hr prior to anesthesia
168704|NCT01486615|E2|Reported Event|Melatonin and Alprazolam|premedicated 1-2 hrs prior to anesthesia
168707|NCT01486446|B2|Baseline|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
168708|NCT01486446|B1|Baseline|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
168709|NCT01486446|P2|Participant Flow|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
168710|NCT01486446|P1|Participant Flow|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
168711|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
168712|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
168713|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
168714|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
168715|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
168716|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
168717|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
168718|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
168719|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
168720|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
168721|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
168722|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
168723|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
168724|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
168725|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
168726|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
168727|NCT01486446|E2|Reported Event|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
168728|NCT01486446|E1|Reported Event|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
168729|NCT01486238|B3|Baseline|Total|Total of all reporting groups
168730|NCT01486238|B2|Baseline|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
168731|NCT01486238|B1|Baseline|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
168732|NCT01486238|P2|Participant Flow|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
168733|NCT01486238|P1|Participant Flow|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
168734|NCT01486238|O2|Outcome|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
168735|NCT01486238|O1|Outcome|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
168736|NCT01486238|E2|Reported Event|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
168737|NCT01486238|E1|Reported Event|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
168738|NCT01486043|B1|Baseline|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
168739|NCT01486043|P1|Participant Flow|Metformin and Insulin Therapy|"For the prospectively recruited arm (metformin plus insulin therapy), a total of 4 subjects were recruited. Two subjects were withdrawn from the study after laboratory studies revealed liver enzymes (AST) levels that were above that allowed for the study at the time. An additional 2 subjects were recruited in the study.
For the retrospective chart review portion of our study, 12 patients were included after conducting chart review of cases from January 2007 to August 2011."
168740|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
168741|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
168742|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
168743|NCT01486043|E1|Reported Event|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
168744|NCT01485991|B3|Baseline|Total|Total of all reporting groups
168745|NCT01485991|B2|Baseline|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
168746|NCT01485991|B1|Baseline|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
168747|NCT01485991|P2|Participant Flow|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
168748|NCT01485991|P1|Participant Flow|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
168749|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
168750|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
168751|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
168752|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
168753|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
168754|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
168755|NCT01485991|E2|Reported Event|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
168756|NCT01485991|E1|Reported Event|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
168757|NCT01485887|B1|Baseline|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168758|NCT01485887|P1|Participant Flow|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168759|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168791|NCT01485640|B1|Baseline|Lurasidone|"Lurasidone flexibly dosed
Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
168792|NCT01485640|P1|Participant Flow|Lurasidone|"Lurasidone flexibly dosed
Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
168793|NCT01485640|O1|Outcome|Lurasidone|"Lurasidone flexibly dosed
Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
168797|NCT01485536|P1|Participant Flow|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
168798|NCT01485536|O1|Outcome|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
168799|NCT01485536|O1|Outcome|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
169462|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
168760|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168761|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168762|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168763|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168764|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168765|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168766|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168767|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168794|NCT01485640|O1|Outcome|Lurasidone|"Lurasidone flexibly dosed
Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
168795|NCT01485640|E1|Reported Event|Lurasidone|"Lurasidone flexibly dosed
Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
168768|NCT01485887|E1|Reported Event|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
168769|NCT01485796|B1|Baseline|Subcutaneous Treatment With IGI, 10% and rHuPH20|This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route).
168770|NCT01485796|P1|Participant Flow|Subcutaneous Treatment With IGI, 10% and rHuPH20|Subcutaneous treatment with IGI, 10% and rHuPH20 occurred in 2 study epochs. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up. During the safety-follow up, subjects received IGI, 10% by either the IV or the SC route.
168771|NCT01485796|O1|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
168772|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
168773|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
168774|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
168775|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
168776|NCT01485796|O1|Outcome|Epoch 2 Data Set|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
168777|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
168778|NCT01485796|O2|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
168779|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
168780|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
168781|NCT01485796|O2|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
168782|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
168783|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
168784|NCT01485796|O1|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
168785|NCT01485796|O1|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
168786|NCT01485796|O2|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
168787|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
168788|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
168789|NCT01485796|E2|Reported Event|Safety Follow-up (n=26)|Treatment with rHuPH20 was stopped as of August 2012 following discussion with the FDA. This decision was based on theoretical risks of exposure to anti-rHuPH20 antibodies, not because of any clinical adverse events. 26 subjects still active in Epoch 2 of the study went into a safety follow-up period and were treated with IGI, 10% (GAMMAGARD LIQUID) either intravenously or subcutaneously.
168790|NCT01485796|E1|Reported Event|Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37)|This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route).
168796|NCT01485536|B1|Baseline|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
168800|NCT01485536|E1|Reported Event|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
168801|NCT01485380|B1|Baseline|Active Study Arm|"Subjects recruited into this study will be required to undergo two MRI-PET scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.
dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
168802|NCT01485380|P1|Participant Flow|Active Study Arm|"Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.
dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
168803|NCT01485380|O1|Outcome|Active Study Arm|"Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography (MRI-PET) scans of the brain in addition to high density electroencephalogram (EEG) acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.
dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss on consciousness is initially observed. Loss on consciousness will be assayed by specific auditory and verbal stimuli."
168804|NCT01485380|E1|Reported Event|Active Study Arm|"Subjects recruited into this study will be required to undergo two MR-PET scans of the brain in addition to high density EEG acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.
dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
168805|NCT01485354|B1|Baseline|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
168806|NCT01485354|P1|Participant Flow|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
168807|NCT01485354|O1|Outcome|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
168808|NCT01485354|O1|Outcome|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
168809|NCT01485354|O1|Outcome|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
168810|NCT01485354|O1|Outcome|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
168811|NCT01485354|O1|Outcome|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
168812|NCT01485354|E1|Reported Event|Armeo Spring Training|"Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks"
168813|NCT01485172|B7|Baseline|Total|Total of all reporting groups
168814|NCT01485172|B6|Baseline|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168815|NCT01485172|B5|Baseline|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168816|NCT01485172|B4|Baseline|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168926|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168849|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168817|NCT01485172|B3|Baseline|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168818|NCT01485172|B2|Baseline|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168819|NCT01485172|B1|Baseline|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168820|NCT01485172|P6|Participant Flow|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168821|NCT01485172|P5|Participant Flow|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168822|NCT01485172|P4|Participant Flow|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168823|NCT01485172|P3|Participant Flow|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168824|NCT01485172|P2|Participant Flow|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168825|NCT01485172|P1|Participant Flow|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168826|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168827|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168828|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168829|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168830|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168831|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168832|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
169019|NCT01484652|E2|Reported Event|Placebo|2 tablets taken every 12 hours
168833|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168834|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168835|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168836|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168837|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168838|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168839|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168840|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168841|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168842|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168843|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168844|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168845|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168846|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168847|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168848|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168850|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168851|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168852|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168853|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168854|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168855|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168856|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168857|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168858|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168859|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168860|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168861|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168862|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168863|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168864|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
169020|NCT01484652|E1|Reported Event|COV795|2 tablets taken every 12 hours
168897|NCT01485172|E1|Reported Event|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168865|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168866|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168867|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168868|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168869|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168870|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168871|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168872|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168873|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168874|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168875|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168876|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168877|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168878|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168879|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168880|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168927|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168881|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168882|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168883|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168884|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168885|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168886|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168887|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168888|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168889|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168890|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168891|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
168892|NCT01485172|E6|Reported Event|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168893|NCT01485172|E5|Reported Event|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168894|NCT01485172|E4|Reported Event|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168895|NCT01485172|E3|Reported Event|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168896|NCT01485172|E2|Reported Event|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
168899|NCT01485094|B3|Baseline|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168900|NCT01485094|B2|Baseline|GRT6010|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
GRT6010: Oral solution given once daily."
168901|NCT01485094|B1|Baseline|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168902|NCT01485094|P3|Participant Flow|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168903|NCT01485094|P2|Participant Flow|GRT6010|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
GRT6010: Oral solution given once daily."
168904|NCT01485094|P1|Participant Flow|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo: Matching Placebo capsules to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168905|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168906|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168907|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168908|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168909|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168910|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168911|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168912|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168913|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168914|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168915|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168916|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168917|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168918|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168919|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168920|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168921|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168922|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168923|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168924|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168925|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
169012|NCT01484652|B3|Baseline|Total|Total of all reporting groups
169013|NCT01484652|B2|Baseline|Placebo|2 tablets taken every 12 hours
168928|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168929|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168930|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168931|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168932|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168933|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168934|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168935|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168936|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168937|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168938|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168939|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168940|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168941|NCT01485094|E3|Reported Event|Pregabalin|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
Pregabalin: Pregabalin capsules 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
168942|NCT01485094|E2|Reported Event|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
GRT6010: Oral solution given once daily."
168943|NCT01485094|E1|Reported Event|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
Matching Placebo: Matching Placebo capsules to the Pregabalin capsules and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily."
168944|NCT01484977|B1|Baseline|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).
Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks."
168945|NCT01484977|P1|Participant Flow|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).
Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks."
168946|NCT01484977|O1|Outcome|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).
Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks."
168947|NCT01484977|E1|Reported Event|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).
Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks."
168948|NCT01484951|B1|Baseline|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
168949|NCT01484951|P1|Participant Flow|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
168950|NCT01484951|O1|Outcome|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
168951|NCT01484951|O1|Outcome|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
168952|NCT01484951|E1|Reported Event|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
168953|NCT01484938|B1|Baseline|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
169014|NCT01484652|B1|Baseline|COV795|2 tablets taken every 12 hours
169021|NCT01484561|B3|Baseline|Total|Total of all reporting groups
168954|NCT01484938|P1|Participant Flow|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
172775|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
168955|NCT01484938|O1|Outcome|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
168956|NCT01484938|O1|Outcome|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
168957|NCT01484938|E1|Reported Event|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
168958|NCT01484912|B3|Baseline|Total|Total of all reporting groups
168959|NCT01484912|B2|Baseline|Placebo|"Placebo capsule, containing non-active ingredients.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168960|NCT01484912|B1|Baseline|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168961|NCT01484912|P2|Participant Flow|Placebo|"Placebo capsule, containing non-active ingredients.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168962|NCT01484912|P1|Participant Flow|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168963|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168964|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168965|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168966|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168967|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168968|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168969|NCT01484912|E2|Reported Event|Placebo|"Placebo capsule, containing non-active ingredients.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168970|NCT01484912|E1|Reported Event|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.
Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
168971|NCT01484873|B1|Baseline|Exenatide|exenatide 10 mcg twice daily
168972|NCT01484873|P1|Participant Flow|Exenatide|exenatide 10 mcg twice daily
168973|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
168974|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
168975|NCT01484873|O1|Outcome|Exenatide|Exenatide: Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
168976|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
168977|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
168978|NCT01484873|E1|Reported Event|Exenatide|exenatide 10 mcg twice daily
168979|NCT01484834|B5|Baseline|Total|Total of all reporting groups
168980|NCT01484834|B4|Baseline|Control Company|Participants did not receive any intervention
168981|NCT01484834|B3|Baseline|Educational Intervention|Participants received educational intervention only
168982|NCT01484834|B2|Baseline|Exercise in the Workplace|Participants received exercise only
168983|NCT01484834|B1|Baseline|Exercise in the Workplace and Educational Intervention|Participants received exercise in the workplace and educational intervention
168984|NCT01484834|P4|Participant Flow|Control Company|No intervention. Control group received no intervention during study period
168985|NCT01484834|P3|Participant Flow|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
168986|NCT01484834|P2|Participant Flow|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
168987|NCT01484834|P1|Participant Flow|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
168988|NCT01484834|O4|Outcome|Control Company|No intervention. Control group received no intervention during study period
168989|NCT01484834|O3|Outcome|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
168990|NCT01484834|O2|Outcome|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
169015|NCT01484652|P2|Participant Flow|Placebo|2 tablets taken every 12 hours at Hour 0, 12, 24, and 36; total of 4 doses
169016|NCT01484652|P1|Participant Flow|COV795|2 tablets taken every 12 hours at Hour 0, 12, 24, and 36; total of 4 doses
169144|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
168991|NCT01484834|O1|Outcome|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
168992|NCT01484834|O4|Outcome|Control Company|No intervention. Control group received no intervention during study period
168993|NCT01484834|O3|Outcome|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
168994|NCT01484834|O2|Outcome|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
168995|NCT01484834|O1|Outcome|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
168996|NCT01484834|O4|Outcome|Control Company|No intervention. Control group received no intervention during study period
168997|NCT01484834|O3|Outcome|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
168998|NCT01484834|O2|Outcome|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
168999|NCT01484834|O1|Outcome|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
169000|NCT01484834|O4|Outcome|Control Company|No intervention. Control group received no intervention during study period
169001|NCT01484834|O3|Outcome|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
169002|NCT01484834|O2|Outcome|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
169003|NCT01484834|O1|Outcome|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
169004|NCT01484834|O4|Outcome|Control Company|No intervention. Control group received no intervention during study period
169005|NCT01484834|O3|Outcome|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
169006|NCT01484834|O2|Outcome|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
169007|NCT01484834|O1|Outcome|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
169008|NCT01484834|E4|Reported Event|Control Company|No intervention. Control group received no intervention during study period
169009|NCT01484834|E3|Reported Event|Educational Intervention|"This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
169010|NCT01484834|E2|Reported Event|Exercise in the Workplace|"Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
169011|NCT01484834|E1|Reported Event|Exercise in the Workplace and Educational Intervention|"Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
169022|NCT01484561|B2|Baseline|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169023|NCT01484561|B1|Baseline|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169024|NCT01484561|P2|Participant Flow|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169025|NCT01484561|P1|Participant Flow|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169026|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169027|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169028|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169029|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169030|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169031|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169032|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169033|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169034|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169035|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169036|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169037|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169038|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169039|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169040|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169041|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169042|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169043|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169044|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169045|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169046|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169047|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169141|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169048|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169049|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169050|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169051|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169052|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169053|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169054|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169055|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169056|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169057|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169058|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169059|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169060|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169061|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169062|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169063|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169064|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169065|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169066|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169067|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169068|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169069|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169070|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169071|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169072|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169073|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169142|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169074|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169075|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169076|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169077|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169078|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169079|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169080|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169081|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169082|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169083|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169084|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169085|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169086|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169087|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169088|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169089|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169090|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169091|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169092|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169093|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169094|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169095|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169096|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169097|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169098|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169099|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169143|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169100|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169101|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169102|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169103|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169104|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169105|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169106|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169107|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169108|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169109|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169110|NCT01484561|E2|Reported Event|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
169111|NCT01484561|E1|Reported Event|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
169112|NCT01484496|B3|Baseline|Total|Total of all reporting groups
169113|NCT01484496|B2|Baseline|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169114|NCT01484496|B1|Baseline|Placebo SC|Par. received placebo administered SC, once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169115|NCT01484496|P4|Participant Flow|Open-Label - Belimumab 200 SC to Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly
169116|NCT01484496|P3|Participant Flow|Open-Label - Placebo SC to Belimumab 200 mg SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
169117|NCT01484496|P2|Participant Flow|Belimumab 200 mg SC|Par. received belimumab 200 milligrams (mg) administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169118|NCT01484496|P1|Participant Flow|Placebo SC|Par. received placebo administered subcutaneously (SC) once weekly through 51 weeks of thetreatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169119|NCT01484496|O2|Outcome|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169120|NCT01484496|O1|Outcome|Placebo SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169121|NCT01484496|O2|Outcome|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169122|NCT01484496|O1|Outcome|Placebo SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169123|NCT01484496|O2|Outcome|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169124|NCT01484496|O1|Outcome|Placebo SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169125|NCT01484496|E4|Reported Event|Open-Label - Belimumab 200 SC to Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
169126|NCT01484496|E3|Reported Event|Open-Label - Placebo SC to Belimumab 200 mg SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
169127|NCT01484496|E2|Reported Event|Belimumab 200 mg SC|Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169128|NCT01484496|E1|Reported Event|Placebo SC|Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
169129|NCT01484314|B1|Baseline|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy
Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
169130|NCT01484314|P1|Participant Flow|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy
Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
169131|NCT01484314|O1|Outcome|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy
Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
169132|NCT01484314|O1|Outcome|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy
Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
169133|NCT01484314|O1|Outcome|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy
Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
169134|NCT01484314|E1|Reported Event|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy
Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
169135|NCT01484197|B1|Baseline|All Participants|All participants randomized to one of four treatment sequences.
169136|NCT01484197|P4|Participant Flow|Sequence 4|Treatment Period 1: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
169137|NCT01484197|P3|Participant Flow|Sequence 3|Treatment Period 1: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
169138|NCT01484197|P2|Participant Flow|Sequence 2|Treatment Period 1: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM ) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
169139|NCT01484197|P1|Participant Flow|Sequence 1|Treatment Period 1: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
169140|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169229|NCT01484054|B1|Baseline|All Subjects|All enrolled subjects who received study lenses.
169145|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169146|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169147|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169148|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169149|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169150|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169151|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169152|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169153|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169154|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169155|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169156|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169157|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169158|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169159|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169160|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169161|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169162|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169163|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169164|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169165|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169166|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169167|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169168|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169169|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169170|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169171|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169172|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169173|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169174|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169175|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169176|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169177|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169178|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169179|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169180|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169181|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169182|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169183|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169184|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169185|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169186|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169187|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169188|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169189|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169190|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169191|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169192|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169193|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169194|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169195|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169196|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169197|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169198|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169199|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169200|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169201|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169202|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169203|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169204|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169205|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169206|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169207|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169208|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169209|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169210|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169211|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169212|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169213|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169214|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169215|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169216|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169217|NCT01484197|E4|Reported Event|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
169218|NCT01484197|E3|Reported Event|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
169219|NCT01484197|E2|Reported Event|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
169220|NCT01484197|E1|Reported Event|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
169221|NCT01484132|B1|Baseline|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
169222|NCT01484132|P1|Participant Flow|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
169223|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
169224|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
169225|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
169226|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
169227|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
169228|NCT01484132|E1|Reported Event|Composite|Restoration of dental caries with dental composite: Dental Resin Restoration (bisphenol A diglycidyl ether methacrylate based composite)
169266|NCT01483963|B1|Baseline|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169230|NCT01484054|P2|Participant Flow|EADE/EAPVPDE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
169231|NCT01484054|P1|Participant Flow|EAPVPDE/EADE|etafilcon A with embedded print and PVP for dark eyes lens worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
169232|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
169233|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens
169234|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
169235|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens
169236|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
169237|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens.
169238|NCT01484054|E2|Reported Event|EADE|etafilcon a existing, daily disposable contact lens.
169239|NCT01484054|E1|Reported Event|EAPVPDE|etafilcon A material incorporating PVP in the blister packaging solution.
169240|NCT01484041|B1|Baseline|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor
Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest
Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
169241|NCT01484041|P1|Participant Flow|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor
Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest
Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
169242|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor
Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest
Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
169243|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor
Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest
Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
169244|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor
Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest
Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
169245|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor
Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest
Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
169246|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor
Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest
Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
169247|NCT01484041|E1|Reported Event|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor
Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest
Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
169248|NCT01484028|B1|Baseline|All Subjects|All randomized subjects who worn at least one pair of study lenses.
169249|NCT01484028|P4|Participant Flow|EALE/1DM|etafilcon A for light eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
169250|NCT01484028|P3|Participant Flow|EADE/1DM|etafilcon A for dark eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
169251|NCT01484028|P2|Participant Flow|1DM/EALE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for light eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
169252|NCT01484028|P1|Participant Flow|1DM/EADE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for dark eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
169253|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lenses to correct myopia, two were discontinued between the first and second periods.
169254|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
169255|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lenses to correct myopia.
169256|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
169257|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lens to correct myopia.
169258|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
169259|NCT01484028|E2|Reported Event|Etafilcon A Control Lenses|A marketed daily disposable contact lens to correct myopia.
169260|NCT01484028|E1|Reported Event|Etafilcon A With PVP for Dark/Light Eyes|A daily disposable contact lens to correct myopia.
169261|NCT01483963|B6|Baseline|Total|Total of all reporting groups
169262|NCT01483963|B5|Baseline|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169263|NCT01483963|B4|Baseline|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169264|NCT01483963|B3|Baseline|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169265|NCT01483963|B2|Baseline|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169267|NCT01483963|P5|Participant Flow|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169268|NCT01483963|P4|Participant Flow|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169269|NCT01483963|P3|Participant Flow|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169270|NCT01483963|P2|Participant Flow|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169271|NCT01483963|P1|Participant Flow|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169272|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169273|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169274|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169275|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169276|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169277|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169278|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169279|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169280|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169281|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169282|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169283|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169284|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169285|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169286|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169287|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169288|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169289|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169290|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169291|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169292|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169293|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169294|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169295|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169296|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169297|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169298|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169299|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169300|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169301|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169302|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169303|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169304|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169305|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
192357|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
169306|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169307|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169308|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169309|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169310|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169311|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169312|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169313|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169314|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169315|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169316|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169317|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169318|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169319|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169320|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169321|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169322|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169323|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169324|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169325|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169326|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169327|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169328|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169329|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169330|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169331|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169332|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169333|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169334|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169335|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169336|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169337|NCT01483963|E5|Reported Event|Shoulder Exercises Only|"Home shoulder exercises for 64 days
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169338|NCT01483963|E4|Reported Event|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169339|NCT01483963|E3|Reported Event|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169340|NCT01483963|E2|Reported Event|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169341|NCT01483963|E1|Reported Event|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
169342|NCT01483937|B3|Baseline|Total|Total of all reporting groups
169343|NCT01483937|B2|Baseline|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
169344|NCT01483937|B1|Baseline|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
169345|NCT01483937|P2|Participant Flow|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
169346|NCT01483937|P1|Participant Flow|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
169380|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
169381|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
169347|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
169348|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
169349|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
169350|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
169351|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
169352|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
Conventional physical therapy only: Subjects received usual care physical therapy from vestibular and balance specialists."
169353|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
169354|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
169355|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
169356|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
169357|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
169358|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
169359|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
169360|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
169361|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
169362|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
169363|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
169364|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
169365|NCT01483937|E2|Reported Event|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
169366|NCT01483937|E1|Reported Event|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
169367|NCT01483924|B6|Baseline|Total|Total of all reporting groups
169368|NCT01483924|B5|Baseline|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
169369|NCT01483924|B4|Baseline|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169370|NCT01483924|B3|Baseline|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
169371|NCT01483924|B2|Baseline|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
169372|NCT01483924|B1|Baseline|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
169373|NCT01483924|P5|Participant Flow|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
169374|NCT01483924|P4|Participant Flow|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169375|NCT01483924|P3|Participant Flow|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
169376|NCT01483924|P2|Participant Flow|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
169377|NCT01483924|P1|Participant Flow|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
169378|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
169379|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169382|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
169383|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
169384|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169385|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
169386|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
169387|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
169388|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
169389|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169390|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
169391|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
169392|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
169393|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
169394|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169395|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks
169396|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks
169397|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
169398|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
169399|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169400|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
169401|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
169402|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
169403|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169404|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
169405|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
169406|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
169407|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169408|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
169409|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
169410|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
169411|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169412|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
169413|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
169414|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
169415|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169416|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
169417|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
169418|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
169419|NCT01483924|E5|Reported Event|Apo805K1 100 mg|Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
169420|NCT01483924|E4|Reported Event|Apo805K1 60 mg|Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
169421|NCT01483924|E3|Reported Event|Apo805K1 30 mg|Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks
169422|NCT01483924|E2|Reported Event|Apo805K1 10 mg|Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks
169423|NCT01483924|E1|Reported Event|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
169424|NCT01483820|B1|Baseline|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
169425|NCT01483820|P1|Participant Flow|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
169426|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
169427|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
169428|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
169429|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
169430|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
169431|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
169432|NCT01483820|E1|Reported Event|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
169433|NCT01483651|B1|Baseline|All Study Participants|Regular insulin given at each of three study visits with a different infusion rate at each visit, either low, medium or high insulin infusion with glucagon administration.
169434|NCT01483651|P6|Participant Flow|High, Medium and Low Insulin Infusion|"All study subjects in this arm were randomized as follows:
First study is regular insulin infused at highest level with glucagon administration.
Second study is regular insulin infused at medium level with glucagon adminstration.
Third study is regular insulin infused at lowest level with glucagon administration."
169435|NCT01483651|P5|Participant Flow|High, Low and Medium Insulin Infusion|"All study subjects in this arm were randomized as follows:
First study is regular insulin infused at highest level with glucagon administration.
Second study is regular insulin infused at lowest level with glucagon adminstration.
Third study is regular insulin infused at medium level with glucagon administration."
169436|NCT01483651|P4|Participant Flow|Medium, High and Low Insulin Infusion|"All study subjects in this arm were randomized as follows:
First study is regular insulin infused at medium level with glucagon administration.
Second study is regular insulin infused at highest level with glucagon adminstration.
Third study is regular insulin infused at lowest level with glucagon administration."
169437|NCT01483651|P3|Participant Flow|Medium, Low and High Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:
First study is regular insulin infused at medium level with glucagon administration.
Second study is regular insulin infused at lowest level with glucagon adminstration.
Third study is regular insulin infused at highest level with glucagon administration."
169438|NCT01483651|P2|Participant Flow|Low, High and Medium Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:
First study is regular insulin infused at lowest level with glucagon administration.
Second study is regular insulin infused at highest level with glucagon adminstration.
Third study is regular insulin infused at medium level with glucagon administration."
169439|NCT01483651|P1|Participant Flow|Low, Medium and High Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:
First study is regular insulin infused at lowest level with glucagon administration.
Second study is regular insulin infused at medium level with glucagon adminstration.
Third study is regular insulin infused at highest level with glucagon administration."
169440|NCT01483651|O3|Outcome|High Insulin Infusion Rate|Regular insulin infused at highest level with glucagon administration.
169441|NCT01483651|O2|Outcome|Medium Insulin Infusion Rate|Regular insulin infused at medium level with glucagon administration.
169442|NCT01483651|O1|Outcome|Low Insulin Infusion Rate|Regular insulin infused at lowest level of glucagon administration.
169443|NCT01483651|E3|Reported Event|High Insulin Infusion|regular insulin infused at highest level with glucagon administration.
169444|NCT01483651|E2|Reported Event|Medium Insulin Infusion|Regular insulin infused at medium level with glucagon administration.
169445|NCT01483651|E1|Reported Event|Low Insulin Infusion|Regular insulin infused at lowest level with glucagon administration.
169446|NCT01483625|B3|Baseline|Total|Total of all reporting groups
169447|NCT01483625|B2|Baseline|Tiotropium 18mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
169448|NCT01483625|B1|Baseline|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
169449|NCT01483625|P2|Participant Flow|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
169450|NCT01483625|P1|Participant Flow|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
169451|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
169452|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
169453|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
169454|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
169455|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
169456|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
169457|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
169458|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
169459|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
169460|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
169461|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
169463|NCT01483625|E2|Reported Event|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
169464|NCT01483625|E1|Reported Event|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
169465|NCT01483599|B8|Baseline|Total|Total of all reporting groups
169466|NCT01483599|B7|Baseline|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
169467|NCT01483599|B6|Baseline|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169468|NCT01483599|B5|Baseline|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169469|NCT01483599|B4|Baseline|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169470|NCT01483599|B3|Baseline|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169471|NCT01483599|B2|Baseline|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169472|NCT01483599|B1|Baseline|Placebo|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
169473|NCT01483599|P14|Participant Flow|Adalimumab (After CP)|Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
169474|NCT01483599|P13|Participant Flow|CNTO1959 200 mg (After CP)|Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.
169475|NCT01483599|P12|Participant Flow|CNTO1959 100 mg (After CP)|Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.
169476|NCT01483599|P11|Participant Flow|CNTO1959 50 mg (After CP)|Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.
169477|NCT01483599|P10|Participant Flow|CNTO1959 15 mg (After CP)|Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.
169478|NCT01483599|P9|Participant Flow|CNTO1959 5 mg (After CP)|Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.
169479|NCT01483599|P8|Participant Flow|Placebo -> 100 mg CNTO1959 (After CP)|Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.
169480|NCT01483599|P7|Participant Flow|Adalimumab (CP)|Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.
169481|NCT01483599|P6|Participant Flow|CNTO1959 200 mg (CP)|Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
169482|NCT01483599|P5|Participant Flow|CNTO1959 100 mg (CP)|Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
169483|NCT01483599|P4|Participant Flow|CNTO1959 50 mg (CP)|Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
169484|NCT01483599|P3|Participant Flow|CNTO1959 15 mg (CP)|Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
169485|NCT01483599|P2|Participant Flow|CNTO1959 5 mg (CP)|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
169486|NCT01483599|P1|Participant Flow|Placebo (CP)|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
169487|NCT01483599|O7|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
169488|NCT01483599|O6|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169489|NCT01483599|O5|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169490|NCT01483599|O4|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169491|NCT01483599|O3|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169492|NCT01483599|O2|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169493|NCT01483599|O1|Outcome|Placebo|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
169494|NCT01483599|O6|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
169495|NCT01483599|O5|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169496|NCT01483599|O4|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169497|NCT01483599|O3|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169498|NCT01483599|O2|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169499|NCT01483599|O1|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169500|NCT01483599|O6|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
169501|NCT01483599|O5|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169502|NCT01483599|O4|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169503|NCT01483599|O3|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169504|NCT01483599|O2|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169505|NCT01483599|O1|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169506|NCT01483599|O7|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
169507|NCT01483599|O6|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169508|NCT01483599|O5|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169509|NCT01483599|O4|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169510|NCT01483599|O3|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169511|NCT01483599|O2|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169512|NCT01483599|O1|Outcome|Placebo|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
169513|NCT01483599|O7|Outcome|Adalimumab|Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
169514|NCT01483599|O6|Outcome|CNTO1959 200 mg|Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169515|NCT01483599|O5|Outcome|CNTO1959 100 mg|Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169516|NCT01483599|O4|Outcome|CNTO1959 50 mg|Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169517|NCT01483599|O3|Outcome|CNTO1959 15 mg|Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
169518|NCT01483599|O2|Outcome|CNTO1959 5 mg|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
169519|NCT01483599|O1|Outcome|Placebo|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
169520|NCT01483599|E14|Reported Event|Adalimumab (After CP)|Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
169521|NCT01483599|E13|Reported Event|CNTO1959 200 mg (After CP)|Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40.
169522|NCT01483599|E12|Reported Event|CNTO1959 100 mg (After CP)|Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40.
169523|NCT01483599|E11|Reported Event|CNTO1959 50 mg (After CP)|Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40.
169524|NCT01483599|E10|Reported Event|CNTO1959 15 mg (After CP)|Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40.
169525|NCT01483599|E9|Reported Event|CNTO1959 5 mg (After CP)|Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40.
169526|NCT01483599|E8|Reported Event|Placebo -> 100 mg CNTO1959 (After CP)|Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40.
169527|NCT01483599|E7|Reported Event|Adalimumab (CP)|Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15.
169528|NCT01483599|E6|Reported Event|CNTO1959 200 mg (CP)|Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
169529|NCT01483599|E5|Reported Event|CNTO1959 100 mg (CP)|Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
169530|NCT01483599|E4|Reported Event|CNTO1959 50 mg (CP)|Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
169531|NCT01483599|E3|Reported Event|CNTO1959 15 mg (CP)|Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4.
169532|NCT01483599|E2|Reported Event|CNTO1959 5 mg (CP)|Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8.
169816|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169533|NCT01483599|E1|Reported Event|Placebo (CP)|Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8.
169534|NCT01483378|B1|Baseline|Survey Participants|
169706|NCT01482884|E1|Reported Event|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169535|NCT01483378|P2|Participant Flow|Patients Who Declined the Herpes Zoster Vaccine|These eligible subjects completed the survey and then declined to receive the herpes zoster vaccine for free.
169536|NCT01483378|P1|Participant Flow|Patients Who Received the Herpes Zoster Vaccine|These eligible subjects completed the survey and then chose to receive the herpes zoster vaccine for free.
169537|NCT01483378|O2|Outcome|Patients Who Declined the Herpes Zoster Vaccine|Patients who declined to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
169538|NCT01483378|O1|Outcome|Patients Who Received the Herpes Zoster Vaccine|Patients who chose to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
169539|NCT01483378|E2|Reported Event|Subjects Who Declined the Herpes Zoster Vaccine|
169540|NCT01483378|E1|Reported Event|Subjects Who Received the Herpes Zoster Vaccine|
169541|NCT01483352|B1|Baseline|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169542|NCT01483352|P1|Participant Flow|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169543|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169544|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169545|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169546|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169547|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169548|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169549|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169550|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169551|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169552|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169553|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169554|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169555|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169556|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169557|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169558|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169559|NCT01483352|E1|Reported Event|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
169560|NCT01483209|B1|Baseline|Boxtox Injection|Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
169561|NCT01483209|P1|Participant Flow|Boxtox Injection|Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
169562|NCT01483209|O1|Outcome|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia
Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
169563|NCT01483209|O1|Outcome|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia
Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
169564|NCT01483209|E1|Reported Event|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia
Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
169565|NCT01483183|B11|Baseline|Total|Total of all reporting groups
169566|NCT01483183|B10|Baseline|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
169817|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169567|NCT01483183|B9|Baseline|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169568|NCT01483183|B8|Baseline|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169569|NCT01483183|B7|Baseline|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169570|NCT01483183|B6|Baseline|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169571|NCT01483183|B5|Baseline|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169572|NCT01483183|B4|Baseline|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
169573|NCT01483183|B3|Baseline|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169574|NCT01483183|B2|Baseline|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169575|NCT01483183|B1|Baseline|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169576|NCT01483183|P10|Participant Flow|Persistent AF - Placebo|Participants received a single dose of placebo, 10-minute constant rate IV infusion.
169577|NCT01483183|P9|Participant Flow|Persistent AF - OPC-108459 1.55 mg/kg|Participants received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169578|NCT01483183|P8|Participant Flow|Persistent AF - OPC-108459 1.35 mg/kg|Participants received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169579|NCT01483183|P7|Participant Flow|Persistent AF - OPC-108459 0.60 mg/kg|Participants received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169580|NCT01483183|P6|Participant Flow|Persistent AF - OPC-108459 0.40 mg/kg|Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169581|NCT01483183|P5|Participant Flow|Persistent AF - OPC-108459 0.26 mg/kg|Participants received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169582|NCT01483183|P4|Participant Flow|Paroxysmal AF - Placebo|Participants received placebo dose 10-minute constant rate IV infusion.
169583|NCT01483183|P3|Participant Flow|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169584|NCT01483183|P2|Participant Flow|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169585|NCT01483183|P1|Participant Flow|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants received a single dose of OPC-108459 0.26 milligram per kilogram (mg/kg), 10-minute constant rate intravenous (IV) infusion to achieve specified Cmax target.
169586|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
169587|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169588|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169589|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169590|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169591|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169592|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
169593|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169594|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169595|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169596|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
169597|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169598|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169599|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169600|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169601|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169602|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
169603|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169604|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169605|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169606|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
169607|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169608|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169609|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169610|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169611|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169612|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
169613|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169614|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169615|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169616|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
169617|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169618|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169619|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169620|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169621|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169622|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
169623|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169624|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169625|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169626|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169627|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169628|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169629|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169630|NCT01483183|O4|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169631|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169632|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169633|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169634|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169635|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169636|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169637|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169818|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169819|NCT01482221|E3|Reported Event|Placebo|Intravenous infusion
169638|NCT01483183|O4|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169639|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169640|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169641|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169642|NCT01483183|E10|Reported Event|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
169643|NCT01483183|E9|Reported Event|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169644|NCT01483183|E8|Reported Event|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169645|NCT01483183|E7|Reported Event|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169646|NCT01483183|E6|Reported Event|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169647|NCT01483183|E5|Reported Event|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169648|NCT01483183|E4|Reported Event|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
169649|NCT01483183|E3|Reported Event|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169650|NCT01483183|E2|Reported Event|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
169651|NCT01483183|E1|Reported Event|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
169652|NCT01483118|B3|Baseline|Total|Total of all reporting groups
169653|NCT01483118|B2|Baseline|Placebo Arm|"Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal."
169654|NCT01483118|B1|Baseline|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
169655|NCT01483118|P2|Participant Flow|Placebo Arm|"Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal."
169656|NCT01483118|P1|Participant Flow|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
169657|NCT01483118|O2|Outcome|Placebo Arm|"Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal.
Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.25 Change during study +/- cycles/month -0.13"
169658|NCT01483118|O1|Outcome|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.75 Change during study +/- cycles/month +0.23"
169659|NCT01483118|O2|Outcome|Placebo Arm|"Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal."
169660|NCT01483118|O1|Outcome|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
169661|NCT01483118|O2|Outcome|Placebo Arm|"Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal.
Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.25 Change during study +/- cycles/month -0.13"
169662|NCT01483118|O1|Outcome|Cinnamon Extract Arm|"Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.75 Change during study +/- cycles/month +0.23"
169663|NCT01483118|E2|Reported Event|Placebo Arm|"PCOS patients receiving placebo capsules
Placebo: Placebo capsules containing ground cereal."
169664|NCT01483118|E1|Reported Event|Cinnamon Extract Arm|"PCOS patients receiving extract of cinnamon
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months."
169665|NCT01482910|B3|Baseline|Total|Total of all reporting groups
169666|NCT01482910|B2|Baseline|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
169667|NCT01482910|B1|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
169668|NCT01482910|P2|Participant Flow|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
169669|NCT01482910|P1|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
169820|NCT01482221|E2|Reported Event|AZD6765iv 50 mg|Intravenous infusion
169670|NCT01482910|O2|Outcome|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
169671|NCT01482910|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
169672|NCT01482910|O2|Outcome|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
169673|NCT01482910|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
169674|NCT01482910|E4|Reported Event|PDT Then Aflibercept Injection, From Week 28 to Week 52|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data from week 28 up to week 52 was reported.
169675|NCT01482910|E3|Reported Event|Aflibercept Injection, From Week 28 to Week 52|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data from week 28 up to week 52 was reported.
169676|NCT01482910|E2|Reported Event|PDT Treatments, up to Week 28|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data up to week 28 was reported.
169677|NCT01482910|E1|Reported Event|Aflibercept Injection, up to Week 28|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data up to week 28 was reported.
169678|NCT01482884|B3|Baseline|Total|Total of all reporting groups
169679|NCT01482884|B2|Baseline|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169680|NCT01482884|B1|Baseline|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169681|NCT01482884|P2|Participant Flow|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169682|NCT01482884|P1|Participant Flow|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169683|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169684|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169685|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169686|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169687|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169688|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169689|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169690|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169691|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169692|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169693|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169694|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169695|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169696|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169697|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169698|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169699|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169700|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169701|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169702|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169703|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
169704|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169821|NCT01482221|E1|Reported Event|AZD6765iv 100 mg|Intravenous infusion
169705|NCT01482884|E2|Reported Event|Tralokinumab 300 mg|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
169707|NCT01482819|B1|Baseline|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
169708|NCT01482819|P1|Participant Flow|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
169709|NCT01482819|O5|Outcome|Polymacon|test article
169710|NCT01482819|O4|Outcome|Lotrafilcon A|test article
169711|NCT01482819|O3|Outcome|Galyfilcon A|test article
169712|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
169713|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
169714|NCT01482819|O5|Outcome|Polymacon|test article
169715|NCT01482819|O4|Outcome|Lotrafilcon A|test article
169716|NCT01482819|O3|Outcome|Galyfilcon A|test article
169717|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
169718|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
169719|NCT01482819|O5|Outcome|Polymacon|test article
169720|NCT01482819|O4|Outcome|Lotrafilcon A|test article
169721|NCT01482819|O3|Outcome|Galyfilcon A|test article
169722|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
169723|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
169724|NCT01482819|E1|Reported Event|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
169725|NCT01482767|B3|Baseline|Total|Total of all reporting groups
169726|NCT01482767|B2|Baseline|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169727|NCT01482767|B1|Baseline|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169728|NCT01482767|P2|Participant Flow|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169729|NCT01482767|P1|Participant Flow|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169730|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169731|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169732|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169733|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169734|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169735|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169736|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169822|NCT01482091|B3|Baseline|Total|Total of all reporting groups
169823|NCT01482091|B2|Baseline|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
170055|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
169737|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169738|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169739|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169740|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169741|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169742|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169743|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169744|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169745|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169746|NCT01482767|E2|Reported Event|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169747|NCT01482767|E1|Reported Event|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
169748|NCT01482429|B3|Baseline|Total|Total of all reporting groups
169749|NCT01482429|B2|Baseline|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
169750|NCT01482429|B1|Baseline|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
169751|NCT01482429|P2|Participant Flow|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
169752|NCT01482429|P1|Participant Flow|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
169753|NCT01482429|O2|Outcome|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
169754|NCT01482429|O1|Outcome|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
169755|NCT01482429|O2|Outcome|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
169756|NCT01482429|O1|Outcome|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
169757|NCT01482429|E2|Reported Event|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
169758|NCT01482429|E1|Reported Event|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
169759|NCT01482325|B1|Baseline|Subjects Requiring Blood Pressure Monitoring|"Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring
Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor: 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor"
169760|NCT01482325|P1|Participant Flow|Subjects Requiring Blood Pressure Monitoring|"St. Joseph’s Hospital (001), there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. Wisconsin Heart Hospital (002), there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study.
There were enrollment criteria followed by both Site 001 and Site 002 that were provided by the study’s GEHC engineer in order to test the SuperSTAT algorithm. Each set of subjects enrolled under the required enrollment criteria were tested by the GEHC engineer."
192358|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
169761|NCT01482325|O1|Outcome|Subjects Requiring Blood Pressure Monitoring|"St. Joseph’s Hospital (001), there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. Wisconsin Heart Hospital (002), there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study.
There were enrollment criteria followed by both Site 001 and Site 002 that were provided by the study’s GEHC engineer in order to test the SuperSTAT algorithm. Each set of subjects enrolled under the required enrollment criteria were tested by the GEHC engineer."
169762|NCT01482325|E1|Reported Event|Subjects Requiring Blood Pressure Monitoring|"Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring
Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor: 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor
At Site #001 – St. Joseph’s Hospital, there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. There were no adverse events reported.
At Site #002 – Wisconsin Heart Hospital, there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study. There were no adverse events reported."
169763|NCT01482312|B1|Baseline|Overall|This reporting group includes all enrolled participants.
169764|NCT01482312|P3|Participant Flow|Glasses / Lotrafilcon A / Comfilcon A|Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
169765|NCT01482312|P2|Participant Flow|Comfilcon A / Glasses / Lotrafilcon A|Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
169766|NCT01482312|P1|Participant Flow|Lotrafilcon A / Comfilcon A / Glasses|Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
169767|NCT01482312|O3|Outcome|Glasses|Glasses per habitual prescription
169768|NCT01482312|O2|Outcome|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
169769|NCT01482312|O1|Outcome|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
169770|NCT01482312|O3|Outcome|Glasses|Glasses per habitual prescription
169771|NCT01482312|O2|Outcome|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
169772|NCT01482312|O1|Outcome|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
169773|NCT01482312|E3|Reported Event|Glasses|Glasses per habitual prescription
169774|NCT01482312|E2|Reported Event|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
169775|NCT01482312|E1|Reported Event|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
169776|NCT01482221|B4|Baseline|Total|Total of all reporting groups
169777|NCT01482221|B3|Baseline|Placebo|Intravenous infusion
169778|NCT01482221|B2|Baseline|AZD6765 100 mg|Intravenous infusion
169779|NCT01482221|B1|Baseline|AZD6765 50 mg|Intravenous infusion
169780|NCT01482221|P3|Participant Flow|Placebo|Intravenous infusion
169781|NCT01482221|P2|Participant Flow|AZD6765 100 mg|Intravenous infusion
169782|NCT01482221|P1|Participant Flow|AZD6765 50 mg|Intravenous infusion
169783|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169784|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169785|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169786|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169787|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169788|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169789|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169790|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169791|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169792|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169793|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169794|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169795|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169796|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169797|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169798|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169799|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169800|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169801|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169802|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169803|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169804|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169805|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169806|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169807|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169808|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169809|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169810|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169811|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169812|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169813|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
169814|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
169815|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
169824|NCT01482091|B1|Baseline|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169825|NCT01482091|P2|Participant Flow|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169826|NCT01482091|P1|Participant Flow|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169827|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169828|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169829|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169830|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169831|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169832|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169833|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169834|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169835|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169836|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169837|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169838|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169839|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169840|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169841|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169842|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169843|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169844|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169845|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169846|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169847|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169848|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169849|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169850|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169851|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169852|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169853|NCT01482091|E2|Reported Event|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
169854|NCT01482091|E1|Reported Event|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
169855|NCT01482065|B3|Baseline|Total|Total of all reporting groups
169856|NCT01482065|B2|Baseline|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.
Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
169857|NCT01482065|B1|Baseline|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.
Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.
CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
169858|NCT01482065|P2|Participant Flow|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.
Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
169859|NCT01482065|P1|Participant Flow|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.
Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.
CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
169860|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.
Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
169861|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.
Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.
CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
169917|NCT01481558|O2|Outcome|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
169918|NCT01481558|O1|Outcome|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
169919|NCT01481558|E2|Reported Event|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
169922|NCT01481376|P1|Participant Flow|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
172776|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
169862|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.
Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
169863|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.
Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.
CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
169864|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.
Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
169865|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.
Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.
CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
169866|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.
Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
169867|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.
Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.
CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
169868|NCT01482065|E2|Reported Event|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.
Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
169869|NCT01482065|E1|Reported Event|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.
Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.
CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
169870|NCT01481935|B3|Baseline|Total|Total of all reporting groups
169920|NCT01481558|E1|Reported Event|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
169921|NCT01481376|B1|Baseline|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
170053|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
169871|NCT01481935|B2|Baseline|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
169872|NCT01481935|B1|Baseline|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
169873|NCT01481935|P2|Participant Flow|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
169874|NCT01481935|P1|Participant Flow|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
169875|NCT01481935|O2|Outcome|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
169876|NCT01481935|O1|Outcome|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
169877|NCT01481935|E2|Reported Event|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
169878|NCT01481935|E1|Reported Event|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
169879|NCT01481896|B1|Baseline|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
169880|NCT01481896|P1|Participant Flow|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
169881|NCT01481896|O1|Outcome|Patients Satisfied With Outcome of Hip Replacement|"Patient satisfaction was evaluated by asking the question, Are you satisfied with the results of your hip operation? on a questionnaire. Patients could respond Yes or No by filling in the appropriated bubble on the questionnaire."
169882|NCT01481896|O1|Outcome|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
169883|NCT01481896|O2|Outcome|Cup Stability|Based on the most recent follow-up x-ray, the fixation of the cup component implanted in a patient's pelvis was graded as bone ingrown, fibrous stable or loose. A cup was considered fibrous stable if there was a continuous radiolucent line along the interface between the cup and the patient's pelvic bone. A cup was considered loose if it had migrated more than 2 mm or its orientation had changed by at least 5 degrees on the follow-up x-ray compared to the immediate post-operative x-ray. A cup that did not meet the criteria for fibrous stable or loose was considered bone ingrown.
169884|NCT01481896|O1|Outcome|Stem Stability|"Based on the most recent follow-up x-ray, the fixation of the stem component implanted in a patient's femur was graded as bone ingrown, fibrous stable or loose using the criteria defined by Engh, Massin and Suthers in their article titled Roentgenographic assessment of the biologic fixation of porous-surfaced femoral components published in the August 1990 edition of Clinical Orthopaedics and Related Research on pages 107 to 128."
169885|NCT01481896|O2|Outcome|Hips With CT Scans Analyzed for Pelvic Osteolysis|Digital Computed Tomography (CT) scans taken more than 5 years after a patient's hip replacement were used to evaluate pelvic bone loss (osteolysis). Regions of bone loss were traced on CT slices to determine the volume and location of each osteolytic defect using three-dimensional image analysis software (Analyze, Biomedical Imaging Resource, Rochester, MN). For the purposes of reporting, the total number of hips with any evidence of pelvic osteolysis on CT is indicated.
169886|NCT01481896|O1|Outcome|Hips With Radiographs Analyzed for Femoral Osteolysis|Serial x-rays for each hip replacement were analyzed by a single experienced reviewer to identify regions where bone had been lost in the femur. Expansile (ballooned-out) regions of bone loss identified on follow-up x-rays taken at least 4.75 years after their surgery that were not apparent on the immediate post-operative x-ray were considered to be osteolysis. For the purposes of reporting, the total number of hips with any evidence of femoral osteolysis on x-ray is indicated.
169887|NCT01481896|O1|Outcome|Hips With Harris Hip Scores|The Harris Hip Score is an outcome measure used for hip replacements that ranges from 0 (worst) to 100 (best). The score consists of a series of questions related to hip pain, function and range of motion that accumulate a different number of points depending on the response choices. At the time of their follow-up visits, patients completed a standardized questionnaire that included components of the Harris Hip Score and the physician completed a standardized evaluation which included range of motion assessment.
169888|NCT01481896|O2|Outcome|Cup Anteversion Angle|The Cup Anteversion Angle quantifies the front-to-back rotation of the hemispheric implant implanted inside a patient's pelvis to replace their hip socket. When an anterioposterior (front-to-back) x-ray is taken, the circular face of the cup projects onto the x-ray as an ellipse. The ratio of the major axis of the ellipse to the minor axis can be used to calculate the anteversion. A cup rotated anteriorly has positive anteversion. A cup rotated posteriorly has negative anteversion. For this study, the cup Anteversion Angle was measured from digitized x-rays using Dr. John Martell's Hip Suite Analysis Software (University of Chicago, Chicago, IL). Taken together, the abduction and anteversion angle quantify the three-dimensional orientation of the cup.
169889|NCT01481896|O1|Outcome|Cup Abduction Angle|The Cup Abduction Angle quantifies the amount of tilt associated with the hemispheric implant implanted inside a patient's pelvis to replace their hip socket. When an anterioposterior (front-to-back) x-ray is taken, the angle between the face of the cup and a horizontal line defines the Cup Abduction Angle. The line defining the face of the cup is drawn through the uppermost and lowest edges of the cup's projection on the x-ray. For this study, the Cup Abduction Angle was measured from digitized x-rays using Dr. John Martell's Hip Suite Analysis Software (University of Chicago, Chicago, IL).
169890|NCT01481896|O2|Outcome|Patients With Serum Chromium Levels|Patients were recommended to have blood drawn for evaluation of serum chromium levels if they were considered to be active or thought to be at risk for an adverse local tissue reaction. Blood was drawn at our hospital or a facility of the patient's choice. The chromium detection limit was 0.1 micrograms per liter for all labs that performed metal level assessments. Patients with undetectable chromium levels were assigned a value of zero. A patient's chromium level was considered high if it was 7 micrograms per liter or greater.
169891|NCT01481896|O1|Outcome|Patients With Serum Cobalt Levels|Patients were recommended to have blood drawn for evaluation of serum cobalt levels if they were considered to be active or thought to be at risk for an adverse local tissue reaction. Blood was drawn at our hospital or a facility of the patient's choice. Among all the labs that performed metal level assessments, the cobalt detection limit varied from 0.5 to 1.0 microgram per liter. Patients with undetectable cobalt levels were assigned a value of zero. A patient's cobalt level was considered high if it was 7 micrograms per liter or greater.
169892|NCT01481896|E1|Reported Event|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
169893|NCT01481740|B3|Baseline|Total|Total of all reporting groups
169894|NCT01481740|B2|Baseline|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
169895|NCT01481740|B1|Baseline|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
169896|NCT01481740|P2|Participant Flow|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
169897|NCT01481740|P1|Participant Flow|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
169898|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
169899|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
169900|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
169901|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
169902|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
169903|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
169904|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
169905|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
169906|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
169907|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
169908|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
169909|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
169910|NCT01481740|E2|Reported Event|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
169911|NCT01481740|E1|Reported Event|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
169912|NCT01481558|B3|Baseline|Total|Total of all reporting groups
169913|NCT01481558|B2|Baseline|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
169914|NCT01481558|B1|Baseline|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
169915|NCT01481558|P2|Participant Flow|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
169916|NCT01481558|P1|Participant Flow|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
169923|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
169924|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
169925|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
169926|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
169927|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
169928|NCT01481376|E1|Reported Event|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
169929|NCT01481324|B4|Baseline|Total|Total of all reporting groups
169930|NCT01481324|B3|Baseline|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
169931|NCT01481324|B2|Baseline|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
169932|NCT01481324|B1|Baseline|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
169933|NCT01481324|P3|Participant Flow|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
169934|NCT01481324|P2|Participant Flow|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
169935|NCT01481324|P1|Participant Flow|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
169936|NCT01481324|O3|Outcome|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
169937|NCT01481324|O2|Outcome|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
169938|NCT01481324|O1|Outcome|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
169939|NCT01481324|E3|Reported Event|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
169940|NCT01481324|E2|Reported Event|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
169941|NCT01481324|E1|Reported Event|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
169942|NCT01481129|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
169943|NCT01481129|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
169944|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
169945|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
169946|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
169947|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
169948|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
169949|NCT01481129|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
169950|NCT01481116|B4|Baseline|Total|Total of all reporting groups
169951|NCT01481116|B3|Baseline|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
170048|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
192359|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
170054|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
169952|NCT01481116|B2|Baseline|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169953|NCT01481116|B1|Baseline|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
169954|NCT01481116|P3|Participant Flow|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169955|NCT01481116|P2|Participant Flow|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169956|NCT01481116|P1|Participant Flow|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
169957|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169958|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169959|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
169960|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169961|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169962|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
169963|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169964|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169965|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
169966|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169967|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169968|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
169969|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169970|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169971|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
169972|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169973|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
170049|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170050|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
169974|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
169975|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169976|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169977|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
169978|NCT01481116|E3|Reported Event|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169979|NCT01481116|E2|Reported Event|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
169980|NCT01481116|E1|Reported Event|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
169981|NCT01480674|B1|Baseline|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169982|NCT01480674|P1|Participant Flow|Trastuzumab|Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab (Herceptin) as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169983|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169984|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169985|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169986|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169987|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169988|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169989|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169990|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169991|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169992|NCT01480674|E1|Reported Event|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
169993|NCT01480596|B3|Baseline|Total|Total of all reporting groups
169994|NCT01480596|B2|Baseline|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
169995|NCT01480596|B1|Baseline|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
169996|NCT01480596|P2|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170051|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
169997|NCT01480596|P1|Participant Flow|Placebo IV|Participants received 250 milliliter (ml) of a normal saline placebo administered as intravenous (IV) infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
169998|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
169999|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170000|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170001|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170002|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170003|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170004|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170005|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170006|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170007|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170008|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170009|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170010|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170011|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170012|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170013|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170014|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170015|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170016|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170017|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170018|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170019|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170052|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
170020|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170021|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170022|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170023|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170024|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170025|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170026|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170027|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170028|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170029|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170030|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170031|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170032|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170033|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170034|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170035|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170036|NCT01480596|E2|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170037|NCT01480596|E1|Reported Event|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
170038|NCT01480297|B1|Baseline|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).
Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
170039|NCT01480297|P1|Participant Flow|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).
Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
170040|NCT01480297|O1|Outcome|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).
Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
170041|NCT01480297|E1|Reported Event|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).
Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
170042|NCT01480284|B3|Baseline|Total|Total of all reporting groups
170043|NCT01480284|B2|Baseline|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170044|NCT01480284|B1|Baseline|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
170045|NCT01480284|P2|Participant Flow|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170046|NCT01480284|P1|Participant Flow|TDF 300 mg OD|Participants received Tenofovir Disoproxil Fumarate (TDF) 300 milligrams (mg) tablet once daily (OD) and Entecavir Hydrate (ETV) placebo capsule OD for 96 weeks.
170047|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170056|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
170057|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170058|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
170059|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170060|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
170061|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170062|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
170063|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170064|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
170065|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170066|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
170067|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170068|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
170069|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170070|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
170071|NCT01480284|E2|Reported Event|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
170072|NCT01480284|E1|Reported Event|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
170073|NCT01480232|B5|Baseline|Total|Total of all reporting groups
170074|NCT01480232|B4|Baseline|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170075|NCT01480232|B3|Baseline|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170076|NCT01480232|B2|Baseline|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170077|NCT01480232|B1|Baseline|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170078|NCT01480232|P4|Participant Flow|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170079|NCT01480232|P3|Participant Flow|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170080|NCT01480232|P2|Participant Flow|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NRT (nicotine replacement therapy) Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170135|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170136|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170139|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170081|NCT01480232|P1|Participant Flow|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170082|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170083|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170084|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170085|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170086|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170087|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170088|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170089|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170090|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170091|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170092|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170137|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170859|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
170093|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170094|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170095|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170096|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170097|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170098|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170099|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170100|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170101|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170102|NCT01480232|E4|Reported Event|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170103|NCT01480232|E3|Reported Event|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)
Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)
NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170104|NCT01480232|E2|Reported Event|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170138|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
172292|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily
placebo: matching placebo once daily"
170105|NCT01480232|E1|Reported Event|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)
EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
170106|NCT01480219|B3|Baseline|Total|Total of all reporting groups
170107|NCT01480219|B2|Baseline|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
170108|NCT01480219|B1|Baseline|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
170109|NCT01480219|P2|Participant Flow|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
170110|NCT01480219|P1|Participant Flow|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
170111|NCT01480219|O2|Outcome|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
170112|NCT01480219|O1|Outcome|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
170113|NCT01480219|E2|Reported Event|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
170114|NCT01480219|E1|Reported Event|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
170115|NCT01480089|B3|Baseline|Total|Total of all reporting groups
170116|NCT01480089|B2|Baseline|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
170117|NCT01480089|B1|Baseline|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
170118|NCT01480089|P2|Participant Flow|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
170119|NCT01480089|P1|Participant Flow|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
170120|NCT01480089|O2|Outcome|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
170121|NCT01480089|O1|Outcome|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
170122|NCT01480089|O2|Outcome|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
170123|NCT01480089|O1|Outcome|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
170124|NCT01480089|E2|Reported Event|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
170125|NCT01480089|E1|Reported Event|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
170126|NCT01480076|B3|Baseline|Total|Total of all reporting groups
170127|NCT01480076|B2|Baseline|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.
170128|NCT01480076|B1|Baseline|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks.
170129|NCT01480076|P1|Participant Flow|Fampridine|All participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.
170130|NCT01480076|O3|Outcome|All Participants|All participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170131|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170132|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170133|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170134|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170407|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
170140|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170141|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170142|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170143|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170144|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170145|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170146|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170147|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170148|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170149|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170150|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170151|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170152|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170153|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170154|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170155|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170156|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170157|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170158|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170159|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170160|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170161|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170162|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170163|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170164|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170408|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170165|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170166|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170167|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170168|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170169|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170170|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170171|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170172|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170173|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170174|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170175|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170176|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170177|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170178|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170179|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170180|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170181|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170182|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170183|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170184|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170185|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170186|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170187|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170188|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170189|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170190|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170191|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170192|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170193|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170194|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170195|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170196|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170197|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170198|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170199|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170200|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170201|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170202|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170203|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170204|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170205|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170206|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170207|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170208|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170209|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170210|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170211|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170212|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170213|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170214|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170215|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170409|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
192360|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water) o
170216|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170217|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170218|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170219|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170220|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).
Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
170221|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170222|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170223|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170224|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170225|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170226|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170227|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170228|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170229|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170230|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170231|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170232|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170233|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170234|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170235|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170236|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170237|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170238|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170239|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170240|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170241|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170242|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170243|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
170244|NCT01480076|E3|Reported Event|All Participants|All participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170245|NCT01480076|E2|Reported Event|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
170246|NCT01480076|E1|Reported Event|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
172763|NCT01472939|P4|Participant Flow|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
170411|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
170412|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170247|NCT01479868|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170248|NCT01479868|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170249|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170250|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170251|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170252|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170253|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170254|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170255|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170256|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170257|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170258|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
172764|NCT01472939|P3|Participant Flow|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
170259|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170260|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170261|NCT01479868|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
170262|NCT01479777|B1|Baseline|FES Stepping|FES Stepping, twice a week, for 8 weeks.
170263|NCT01479777|P1|Participant Flow|FES Stepping|For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping.
170264|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
170265|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
170266|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
170267|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
170268|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
170269|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
170270|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
170271|NCT01479777|E1|Reported Event|FES Stepping|FES Stepping, twice a week, for 8 weeks.
170272|NCT01479764|B3|Baseline|Total|Total of all reporting groups
170273|NCT01479764|B2|Baseline|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
170274|NCT01479764|B1|Baseline|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
170275|NCT01479764|P2|Participant Flow|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
170276|NCT01479764|P1|Participant Flow|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
170277|NCT01479764|O2|Outcome|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
170278|NCT01479764|O1|Outcome|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
170279|NCT01479764|O2|Outcome|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
170280|NCT01479764|O1|Outcome|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
170281|NCT01479764|E2|Reported Event|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
170282|NCT01479764|E1|Reported Event|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
170283|NCT01479725|B3|Baseline|Total|Total of all reporting groups
170284|NCT01479725|B2|Baseline|Non-Ulcerative IC|"HBOT for non-ulcerative IC
HBOT: HBOT"
170285|NCT01479725|B1|Baseline|Ulcerative IC|"HBOT for ulcerative IC
HBOT: HBOT"
170286|NCT01479725|P2|Participant Flow|Non-Ulcerative IC|"HBOT for non-ulcerative IC
HBOT: HBOT"
170287|NCT01479725|P1|Participant Flow|Ulcerative IC|"HBOT for ulcerative IC
HBOT: HBOT"
170288|NCT01479725|O2|Outcome|Non-Ulcerative IC|"HBOT for non-ulcerative IC
HBOT: HBOT"
170289|NCT01479725|O1|Outcome|Ulcerative IC|"HBOT for ulcerative IC
HBOT: HBOT"
170290|NCT01479725|E2|Reported Event|Non-Ulcerative IC|"HBOT for non-ulcerative IC
HBOT: HBOT"
170291|NCT01479725|E1|Reported Event|Ulcerative IC|"HBOT for ulcerative IC
HBOT: HBOT"
170292|NCT01479621|B7|Baseline|Total|Total of all reporting groups
170293|NCT01479621|B6|Baseline|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170294|NCT01479621|B5|Baseline|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170295|NCT01479621|B4|Baseline|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170296|NCT01479621|B3|Baseline|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170297|NCT01479621|B2|Baseline|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170298|NCT01479621|B1|Baseline|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170299|NCT01479621|P7|Participant Flow|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170300|NCT01479621|P6|Participant Flow|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170301|NCT01479621|P5|Participant Flow|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170302|NCT01479621|P4|Participant Flow|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170303|NCT01479621|P3|Participant Flow|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170304|NCT01479621|P2|Participant Flow|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170305|NCT01479621|P1|Participant Flow|Placebo MDPI (Run-In)|Upon enrollment, participants used current asthma medications and 1 inhalation of placebo multidose dry powder inhaler (MDPI), single-blind, twice daily for 14-day (±2 days).
170306|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170307|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170308|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170309|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170310|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170311|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170410|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170312|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170313|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170314|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170315|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170316|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170317|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170318|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170319|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170320|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170321|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170322|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170323|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170324|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170325|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170326|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170327|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
192361|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
170328|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170329|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170330|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170331|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170332|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170333|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170334|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170335|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170336|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170337|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170338|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170339|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170340|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170341|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170342|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170343|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
192362|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
170344|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170345|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170346|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170347|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170348|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170349|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170350|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170351|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170352|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170353|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170354|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170355|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170356|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170357|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170358|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170359|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170360|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170361|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170362|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170363|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170364|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170365|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170366|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170367|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170368|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170369|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170370|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170371|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170372|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170373|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170374|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170375|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
192363|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
170376|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170377|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170378|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170379|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
170380|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170381|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170382|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170383|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
170384|NCT01479621|E6|Reported Event|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
170385|NCT01479621|E5|Reported Event|Fp MDPI 50 mcg|Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
170386|NCT01479621|E4|Reported Event|Fp MDPI 25 mcg|Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
170387|NCT01479621|E3|Reported Event|Fp MDPI 12.5 mcg|Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
170388|NCT01479621|E2|Reported Event|Fp MDPI 100 mcg|Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
170389|NCT01479621|E1|Reported Event|Flovent Diskus 100mcg|Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
170390|NCT01479595|B3|Baseline|Total|Total of all reporting groups
170391|NCT01479595|B2|Baseline|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
170392|NCT01479595|B1|Baseline|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170393|NCT01479595|P2|Participant Flow|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
170394|NCT01479595|P1|Participant Flow|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170395|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
170396|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170397|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170398|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170399|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170400|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170401|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
170402|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170403|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
170404|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170405|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
170406|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170413|NCT01479595|E2|Reported Event|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
170414|NCT01479595|E1|Reported Event|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
170415|NCT01479543|B6|Baseline|Total|Total of all reporting groups
170416|NCT01479543|B5|Baseline|Group E|"Volunteers receive a placebo.
Placebo capsule: Placebo capsule for 28 days."
170417|NCT01479543|B4|Baseline|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
170418|NCT01479543|B3|Baseline|Group C|"Volunteers are given Probiotic CNCM I-4036.
Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
170419|NCT01479543|B2|Baseline|Group B|"Volunteers receive Probiotic CNCM I-4035.
Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
170420|NCT01479543|B1|Baseline|Group A|"Volunteers are given strain CNCM I-4034.
Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
170421|NCT01479543|P5|Participant Flow|Group E|"Volunteers receive a placebo.
Placebo capsule: Placebo capsule for 28 days."
170422|NCT01479543|P4|Participant Flow|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
170423|NCT01479543|P3|Participant Flow|Group C|"Volunteers are given Probiotic CNCM I-4036.
Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
170424|NCT01479543|P2|Participant Flow|Group B|"Volunteers receive Probiotic CNCM I-4035.
Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
170425|NCT01479543|P1|Participant Flow|Group A|"Volunteers are given strain CNCM I-4034.
Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
170426|NCT01479543|O5|Outcome|Group E|"Volunteers receive a placebo.
Placebo capsule: Placebo capsule for 28 days."
170427|NCT01479543|O4|Outcome|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
170428|NCT01479543|O3|Outcome|Group C|"Volunteers are given Probiotic CNCM I-4036.
Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
170429|NCT01479543|O2|Outcome|Group B|"Volunteers receive Probiotic CNCM I-4035.
Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
170430|NCT01479543|O1|Outcome|Group A|"Volunteers are given strain CNCM I-4034.
Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
170431|NCT01479543|E5|Reported Event|Group E|"Volunteers receive a placebo.
Placebo capsule: Placebo capsule for 28 days."
170432|NCT01479543|E4|Reported Event|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
170433|NCT01479543|E3|Reported Event|Group C|"Volunteers are given Probiotic CNCM I-4036.
Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
170434|NCT01479543|E2|Reported Event|Group B|"Volunteers receive Probiotic CNCM I-4035.
Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
170435|NCT01479543|E1|Reported Event|Group A|"Volunteers are given strain CNCM I-4034.
Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
170436|NCT01479530|B3|Baseline|Total|Total of all reporting groups
170437|NCT01479530|B2|Baseline|Azilect®|1 mg daily; tablet; orally; 16 weeks
170438|NCT01479530|B1|Baseline|Placebo|Once daily; tablet; orally; 16 weeks
170439|NCT01479530|P2|Participant Flow|Azilect®|1 mg daily; tablet; orally; 16 weeks
170440|NCT01479530|P1|Participant Flow|Placebo|Once daily; tablet; orally; 16 weeks
170441|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
170442|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
170443|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
170444|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
170445|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
170446|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
170447|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
170448|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
170449|NCT01479530|E2|Reported Event|Azilect®|1 mg daily; tablet; orally; 16 weeks
170450|NCT01479530|E1|Reported Event|Placebo|Once daily; tablet; orally; 16 weeks
170451|NCT01479517|B4|Baseline|Total|Total of all reporting groups
170452|NCT01479517|B3|Baseline|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
170453|NCT01479517|B2|Baseline|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
170454|NCT01479517|B1|Baseline|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
170455|NCT01479517|P3|Participant Flow|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
170456|NCT01479517|P2|Participant Flow|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
170457|NCT01479517|P1|Participant Flow|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
170458|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
170556|NCT01478971|E1|Reported Event|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
170459|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
170460|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
170461|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
170462|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
170463|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
170464|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
170465|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
170466|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
170467|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
170468|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
170469|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
170470|NCT01479517|E3|Reported Event|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
170471|NCT01479517|E2|Reported Event|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
170472|NCT01479517|E1|Reported Event|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
170473|NCT01479374|B4|Baseline|Total|Total of all reporting groups
170474|NCT01479374|B3|Baseline|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
170475|NCT01479374|B2|Baseline|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
170476|NCT01479374|B1|Baseline|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
170477|NCT01479374|P3|Participant Flow|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
170478|NCT01479374|P2|Participant Flow|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
170479|NCT01479374|P1|Participant Flow|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
170480|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
170481|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
170482|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
170483|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
170484|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
170485|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
170486|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
170487|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
170488|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
170489|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
170490|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
170491|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
170492|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
170493|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
170494|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
170495|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
170496|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
170497|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
170498|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
170499|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
170500|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
170501|NCT01479374|E3|Reported Event|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
170502|NCT01479374|E2|Reported Event|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
170503|NCT01479374|E1|Reported Event|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
170554|NCT01478971|E3|Reported Event|Peginesatide Treatment Period|In the second six months of the study participants transitioned to once monthly peginesatide injection (the Peginesatide Treatment Period [PTP]).
170557|NCT01478958|B4|Baseline|Total|Total of all reporting groups
170558|NCT01478958|B3|Baseline|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
170504|NCT01479127|B1|Baseline|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170505|NCT01479127|P1|Participant Flow|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-Parkinson's disease (PD) medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel [LCIG]), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170506|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170507|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
170508|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
170509|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
170510|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
170511|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
170512|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
170513|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
170514|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
170515|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
170516|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
170517|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170518|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
170519|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170555|NCT01478971|E2|Reported Event|ESA Free Week|A one-week erythropoiesis-stimulating agent (ESA)-free period following 6 months of standard of care.
172765|NCT01472939|P2|Participant Flow|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
170520|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170521|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170522|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170523|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170524|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170525|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170526|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170527|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170528|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170529|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170530|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
192364|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
170531|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170532|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170533|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170534|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170535|NCT01479127|O1|Outcome|Oral Levodopa/Carbidopa Tablet|During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)
170536|NCT01479127|E2|Reported Event|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.
The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
170537|NCT01479127|E1|Reported Event|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
170538|NCT01479010|B1|Baseline|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
170539|NCT01479010|P1|Participant Flow|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
170540|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
170541|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
170542|NCT01479010|E1|Reported Event|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
170543|NCT01478971|B1|Baseline|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
170544|NCT01478971|P1|Participant Flow|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
170545|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
170546|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
170547|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
170548|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
170549|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
170550|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
170551|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
170552|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
170553|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
170559|NCT01478958|B2|Baseline|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
170560|NCT01478958|B1|Baseline|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
170561|NCT01478958|P3|Participant Flow|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
170562|NCT01478958|P2|Participant Flow|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
170563|NCT01478958|P1|Participant Flow|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
170564|NCT01478958|O3|Outcome|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
170565|NCT01478958|O2|Outcome|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
170566|NCT01478958|O1|Outcome|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
170567|NCT01478958|E3|Reported Event|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
170568|NCT01478958|E2|Reported Event|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
170569|NCT01478958|E1|Reported Event|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
170570|NCT01478828|B1|Baseline|Lovastatin|"After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
Lovastatin: oral qd varying dose escalations/de-escalations"
170571|NCT01478828|P1|Participant Flow|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
170572|NCT01478828|O1|Outcome|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
170573|NCT01478828|O1|Outcome|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
170574|NCT01478828|E1|Reported Event|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
170575|NCT01478620|B1|Baseline|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
170576|NCT01478620|P1|Participant Flow|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
170577|NCT01478620|O1|Outcome|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
170578|NCT01478620|E1|Reported Event|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
170579|NCT01478594|B3|Baseline|Total|Total of all reporting groups
170580|NCT01478594|B2|Baseline|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170581|NCT01478594|B1|Baseline|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170582|NCT01478594|P2|Participant Flow|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170583|NCT01478594|P1|Participant Flow|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each 28-day cycle for 21 days followed by 7 days off treatment. Participants also received modified FOLFOX6 (mFOLFOX6) chemotherapy consisting of oxaliplatin, 85 mg/m^2, leucovorin 400 mg/m^2, and 5-fluorouracil 400 mg/m^2 bolus then 2400 mg/m^2 every 2 weeks on Days 1 and 15 of each cycle.
170584|NCT01478594|O4|Outcome|Bevacizumab: PIGF RNA ≥ Median|Participants with PIGF RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170585|NCT01478594|O3|Outcome|Bevacizumab: PIGF RNA < Median|Participants with PIGF RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170586|NCT01478594|O2|Outcome|Tivozanib: PIGF RNA ≥ Median|Participants with PIGF RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170587|NCT01478594|O1|Outcome|Tivozanib: PIGF RNA < Median|Participants with PIGF RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170863|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170588|NCT01478594|O4|Outcome|Bevacizumab: VEGF-D RNA ≥ Median|Participants with VEGF-D RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170589|NCT01478594|O3|Outcome|Bevacizumab: VEGF-D RNA < Median|Participants with VEGF-D RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170590|NCT01478594|O2|Outcome|Tivozanib: VEGF-D RNA ≥ Median|Participants with VEGF-D RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170591|NCT01478594|O1|Outcome|Tivozanib: VEGF-D RNA < Median|Participants with VEGF-D RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170592|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C/VEGF-A RNA ≥ Median|Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170593|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C/VEGF-A RNA < Median|Participants with VEGF-C/VEGF-A RNA ratio < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170594|NCT01478594|O2|Outcome|Tivozanib: VEGF-C/VEGF-A RNA ≥ Median|Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170595|NCT01478594|O1|Outcome|Tivozanib: VEGF-C/VEGF-A RNA < Median|Participants with VEGF-C/VEGF-A RNA ratio < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170596|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A RNA ≥ Median|Participants with VEGF-C RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170597|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C RNA < Median|Participants with VEGF-C RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170598|NCT01478594|O2|Outcome|Tivozanib: VEGF-C RNA ≥ Median|Participants with VEGF-C RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170599|NCT01478594|O1|Outcome|Tivozanib: VEGF-C RNA < Median|Participants with VEGF-C RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170600|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A RNA ≥ Median|Participants with VEGF-A RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170601|NCT01478594|O3|Outcome|Bevacizumab: VEGF-A RNA < Median|Participants with VEGF-A RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170602|NCT01478594|O2|Outcome|Tivozanib: VEGF-A RNA ≥ Median|Participants with VEGF-A RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170603|NCT01478594|O1|Outcome|Tivozanib: VEGF-A RNA < Median|Participants with VEGF-A RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170604|NCT01478594|O4|Outcome|Bevacizumab: Neuropilin ≥ Median|Participants with neuropilin levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170605|NCT01478594|O3|Outcome|Bevacizumab: Neuropilin < Median|Participants with neuropilin levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and FOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170606|NCT01478594|O2|Outcome|Tivozanib: Neuropilin ≥ Median|Participants with neuropilin levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170607|NCT01478594|O1|Outcome|Tivozanib: Neuropilin < Median|Participants with neuropilin levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170608|NCT01478594|O4|Outcome|Bevacizumab: IL-8 ≥ Median|Participants with IL-8 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170609|NCT01478594|O3|Outcome|Bevacizumab: IL-8 < Median|Participants with IL-8 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170610|NCT01478594|O2|Outcome|Tivozanib: IL-8 ≥ Median|Participants with IL-8 levels ≥ median received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170611|NCT01478594|O1|Outcome|Tivozanib: IL-8 < Median|Participants with IL-8 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
172768|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
170612|NCT01478594|O4|Outcome|Bevacizumab: sVEGFR-3 ≥ Median|Participants with sVEGFR-3 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170613|NCT01478594|O3|Outcome|Bevacizumab: sVEGFR-3 < Median|Participants with sVEGFR-3 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170614|NCT01478594|O2|Outcome|Tivozanib: sVEGFR-3 ≥ Median|Participants with sVEGFR-3 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170615|NCT01478594|O1|Outcome|Tivozanib: sVEGFR-3 < Median|Participants with sVEGFR-3 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170616|NCT01478594|O4|Outcome|Bevacizumab: sVEGFR-2 ≥ Median|Participants with sVEGFR-2 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170617|NCT01478594|O3|Outcome|Bevacizumab: sVEGFR-2 < Median|Participants with sVEGFR-2 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170618|NCT01478594|O2|Outcome|Tivozanib: sVEGFR-2 ≥ Median|Participants with sVEGFR-2 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170619|NCT01478594|O1|Outcome|Tivozanib: sVEGFR-2 < Median|Participants with sVEGFR-2 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170620|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C/VEGF-A ≥ Median|Participants with VEGF-C/VEGF-A ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170621|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C/VEGF-A < Median|Participants with VEGF-C/VEGF-A ratio < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170622|NCT01478594|O2|Outcome|Tivozanib: VEGF-C/VEGF-A ≥ Median|Participants with VEGF-C/VEGF-A ratio ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170623|NCT01478594|O1|Outcome|Tivozanib: VEGF-C/VEGF-A < Median|Participants with VEGF-C/VEGF-A ratio < median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170624|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C ≥ Median|Participants with VEGF-C levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170625|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C < Median|Participants with VEGF-C levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170626|NCT01478594|O2|Outcome|Tivozanib: VEGF-C ≥ Median|Participants with VEGF-C levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170627|NCT01478594|O1|Outcome|Tivozanib: VEGF-C < Median|Participants with VEGF-C levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170628|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A ≥ Median|Participants with VEGF-A levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170629|NCT01478594|O3|Outcome|Bevacizumab: VEGF-A < Median|Participants with VEGF-A levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170630|NCT01478594|O2|Outcome|Tivozanib: VEGF-A ≥ Median|Participants with VEGF-A levels ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170631|NCT01478594|O1|Outcome|Tivozanib: VEGF-A < Median|Participants with VEGF-A levels < median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170632|NCT01478594|O4|Outcome|Bevacizumab : LDH ≥ 1.5 ULN|Participants with LDH status ≥ 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170633|NCT01478594|O3|Outcome|Bevacizumab: LDH < 1.5 ULN|Participants with LDH status < 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170634|NCT01478594|O2|Outcome|Tivozanib: LDH ≥ 1.5 ULN|Participants with LDH status ≥ 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170635|NCT01478594|O1|Outcome|Tivozanib: LDH < 1.5 ULN|Participants with LDH status < 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170860|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170636|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170637|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170638|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170639|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170640|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170641|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170642|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170643|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170644|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170645|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170646|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170647|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170648|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170649|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170650|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170651|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170652|NCT01478594|E2|Reported Event|Bevacizumab + mFOLFOX6|Participants received a dose of 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170653|NCT01478594|E1|Reported Event|Tivozanib + mFOLFOX6|Participants received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6) chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
170654|NCT01478373|B1|Baseline|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
170655|NCT01478373|P1|Participant Flow|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
170656|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
170657|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
170658|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
170659|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
170660|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
170661|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
170662|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
170663|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
170664|NCT01478373|E1|Reported Event|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
170665|NCT01478360|B3|Baseline|Total|Total of all reporting groups
170666|NCT01478360|B2|Baseline|Placebo|Placebo intravenous injection
170667|NCT01478360|B1|Baseline|AIN457|AIN457 10 mg/kg
170668|NCT01478360|P2|Participant Flow|Placebo|Placebo intravenous injection
170669|NCT01478360|P1|Participant Flow|AIN457|AIN457 10 mg/kg
170670|NCT01478360|O2|Outcome|Placebo|Placebo intravenous injection
170671|NCT01478360|O1|Outcome|AIN457|AIN457 10 mg/kg
170672|NCT01478360|E2|Reported Event|Placebo|Placebo
170673|NCT01478360|E1|Reported Event|AIN457 10 mg/kg|AIN457 10 mg/kg
170674|NCT01478347|B1|Baseline|rMenB+OMV NZ|"Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. 18 subjects were enrolled in part I of the study.
In part II of the study, subjects were re-enrolled for optional blood draws and safety follow-up. Of the 18 subjects enrolled in part I of the study, only 12 subjects continued participation into protocol part II of the study. Only 11 subjects (one subject was withdrawn after visit 3 due to lost to follow-up) were included in the safety set and therefore contributed to the baseline characteristics data."
170675|NCT01478347|P1|Participant Flow|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
170676|NCT01478347|O1|Outcome|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
170677|NCT01478347|O1|Outcome|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
170678|NCT01478347|E1|Reported Event|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
170679|NCT01478256|B3|Baseline|Total|Total of all reporting groups
170680|NCT01478256|B2|Baseline|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
170681|NCT01478256|B1|Baseline|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
170682|NCT01478256|P2|Participant Flow|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
170683|NCT01478256|P1|Participant Flow|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
170684|NCT01478256|O2|Outcome|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
170685|NCT01478256|O1|Outcome|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
170686|NCT01478256|O2|Outcome|Erythromycin|Topical Erythromycin ointment for treatment of acute blepharitis
170687|NCT01478256|O1|Outcome|Besifloxocin|Use of topical besifloxocin to treat acute blepharitis
170688|NCT01478256|E2|Reported Event|Erythromycin|Topical Erythromycin ointment for treatment of acute blepharitis
170689|NCT01478256|E1|Reported Event|Besifloxocin|Use of topical besifloxocin to treat acute blepharitis
170690|NCT01478113|B3|Baseline|Total|Total of all reporting groups
170691|NCT01478113|B2|Baseline|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170692|NCT01478113|B1|Baseline|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170693|NCT01478113|P2|Participant Flow|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170765|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170766|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170694|NCT01478113|P1|Participant Flow|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170695|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170696|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170697|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170698|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170699|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170700|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170701|NCT01478113|O2|Outcome|WBT + Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170702|NCT01478113|O1|Outcome|WBT + Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine/dextroamphetamine: The amphetamine/dextroamphetamine will be in a pill formulation. The dosage of the amphetamine/dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170703|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170704|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170705|NCT01478113|O2|Outcome|WBT + Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170706|NCT01478113|O1|Outcome|WBT + Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine/dextroamphetamine: The amphetamine/dextroamphetamine will be in a pill formulation. The dosage of the amphetamine/dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170707|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170708|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170709|NCT01478113|E2|Reported Event|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170710|NCT01478113|E1|Reported Event|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
170711|NCT01478087|B1|Baseline|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
170712|NCT01478087|P1|Participant Flow|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
170713|NCT01478087|O1|Outcome|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
170714|NCT01478087|O1|Outcome|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
170715|NCT01478087|E1|Reported Event|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
170716|NCT01478048|B3|Baseline|Total|Total of all reporting groups
170717|NCT01478048|B2|Baseline|Bortezomib + Dexamethasone|"Bortezomib: 1.3 mg/m^2 IV; (Cycles 1 - 8 on Days 1, 4, 8, 11; Cycles 9+ on Days 1, 8, 15.
Dexamethasone: 20 mg oral; (Cycles 1-8 QD on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ QD on Days 1, 2, 8, 9, 15, 16).
Participants were treated until disease progression, unacceptable toxicity, withdrawal of consent, or other criteria for discontinuation."
170718|NCT01478048|B1|Baseline|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: 10 mg/kg Intravenous (IV): In Cycles 1 & 2: Treatment on Days 1, 8 & 15; In Cycles 3-8: on Days 1 & 11; In Cycle 9+: on Days 1 & 15.
Bortezomib: 1.3 mg/m^2 IV or subcutaneous; (Cycles 1 - 8: on Days 1, 4, 8, 11; Cycles 9+: on Days 1, 8, 15
Dexamethasone: On days of elotuzumab infusion, dexamethasone was administered as a split dose of 8mg oral 3 - 24 hours prior to elotuzumab followed by 8mg IV at least 45 minutes prior to elotuzumab. On other non-elotuzumab days, 20 mg oral dexamethasone was given once daily (QD) in Cycles 1 and 2 on Days 2, 4, 5, 9, 11; in Cycles 3 - 8 on Days 2, 4, 5, 8, 9, 12; in Cycles 9+ on Days 2, 8, 9, 16.
Participants were treated until disease progression, unacceptable toxicity, withdrawal of consent, or other criteria for discontinuation."
170719|NCT01478048|P2|Participant Flow|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.
Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
170720|NCT01478048|P1|Participant Flow|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug
Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.
Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered
Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.
Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
170721|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.
Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
170722|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug
Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.
Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered
Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.
Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
170723|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.
Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
170861|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170724|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug
Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.
Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered
Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.
Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
170725|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.
Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
170726|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug
Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.
Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered
Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.
Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
170727|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.
Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
170728|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug
Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.
Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered
Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.
Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
170729|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.
Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
170730|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug
Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.
Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered
Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.
Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
170731|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.
Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
170732|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug
Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.
Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered
Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.
Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
170733|NCT01478048|E2|Reported Event|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.
Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
170767|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170862|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170734|NCT01478048|E1|Reported Event|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; IV; 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.
Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.
Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
170735|NCT01478009|B3|Baseline|Total|Total of all reporting groups
170736|NCT01478009|B2|Baseline|Placebo|
170737|NCT01478009|B1|Baseline|KRG Extract|
170738|NCT01478009|P2|Participant Flow|Placebo|"Placebo(3times/day, 9capsules/day, 3g/day) for 12weeks
Placebo : Amount and calorie of placebo are same with KRG Extract."
170739|NCT01478009|P1|Participant Flow|KRG(Korean Red Ginseng) Extract|"KRG Extract(3times/day, 9capsules/day, 3g/day) for 12weeks
KRG Extract : KRG Extract was extracted at high temperatures (above 95℃)"
170740|NCT01478009|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
170741|NCT01478009|O1|Outcome|KRG Extract|Oral intake Korean red ginseng(3.0g/day) for 12weeks.
170742|NCT01478009|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
170743|NCT01478009|O1|Outcome|KRG Extract|Oral intake Korean red ginseng(3.0g/day) for 12weeks.
170744|NCT01478009|E2|Reported Event|Placebo|
170745|NCT01478009|E1|Reported Event|KRG Extract|
170746|NCT01477892|B3|Baseline|Total|Total of all reporting groups
170747|NCT01477892|B2|Baseline|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min
low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
170748|NCT01477892|B1|Baseline|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min
low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
170749|NCT01477892|P2|Participant Flow|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min
low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
170750|NCT01477892|P1|Participant Flow|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min
low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
170751|NCT01477892|O2|Outcome|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min
low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
170752|NCT01477892|O1|Outcome|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min
low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
170753|NCT01477892|O2|Outcome|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min
low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
170754|NCT01477892|O1|Outcome|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min
low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
170755|NCT01477892|E2|Reported Event|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min
low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
170756|NCT01477892|E1|Reported Event|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min
low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
170757|NCT01477853|B4|Baseline|Total|Total of all reporting groups
170758|NCT01477853|B3|Baseline|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170759|NCT01477853|B2|Baseline|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170760|NCT01477853|B1|Baseline|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170761|NCT01477853|P3|Participant Flow|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170762|NCT01477853|P2|Participant Flow|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170763|NCT01477853|P1|Participant Flow|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170764|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170768|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170769|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170770|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170771|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170772|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170773|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170774|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170775|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170776|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170777|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170778|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170779|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170780|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170781|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170782|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170783|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170784|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170785|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170786|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170787|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170788|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170789|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170916|NCT01477463|O2|Outcome|Arm B: Placebo|Placebo - inactive capsule
170790|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170791|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170792|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170793|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170794|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170795|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170796|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170797|NCT01477853|E3|Reported Event|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
170798|NCT01477853|E2|Reported Event|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
170799|NCT01477853|E1|Reported Event|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
170800|NCT01477762|B5|Baseline|Total|Total of all reporting groups
170801|NCT01477762|B4|Baseline|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170802|NCT01477762|B3|Baseline|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170803|NCT01477762|B2|Baseline|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170804|NCT01477762|B1|Baseline|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170805|NCT01477762|P4|Participant Flow|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170806|NCT01477762|P3|Participant Flow|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170807|NCT01477762|P2|Participant Flow|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170808|NCT01477762|P1|Participant Flow|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170809|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170858|NCT01477567|P1|Participant Flow|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170810|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170811|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170812|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170813|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170814|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170815|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170816|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170817|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170818|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170819|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170820|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170821|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170822|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170823|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170824|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170825|NCT01477762|E4|Reported Event|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170826|NCT01477762|E3|Reported Event|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170827|NCT01477762|E2|Reported Event|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
170828|NCT01477762|E1|Reported Event|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
170829|NCT01477749|B1|Baseline|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
170830|NCT01477749|P1|Participant Flow|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
170831|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
170832|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
170833|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
170834|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
170835|NCT01477749|E1|Reported Event|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
170836|NCT01477710|B1|Baseline|All Participants|Each clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Then, each will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, each will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
170837|NCT01477710|P1|Participant Flow|All Participants|Each participant will perform 3 tasks -- in the same order. First, the clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Next, the clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, the clinician will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
170838|NCT01477710|O3|Outcome|Airway|Using a supraglottic airway
170839|NCT01477710|O2|Outcome|Strap Mask|Mask is strapped to model using a securing device
170840|NCT01477710|O1|Outcome|Hold Mask|Mask is held in place by caregiver.
170841|NCT01477710|E3|Reported Event|Airway|
170842|NCT01477710|E2|Reported Event|Strap Mask|
170843|NCT01477710|E1|Reported Event|Hold Mask|
170844|NCT01477567|B8|Baseline|Total|Total of all reporting groups
170845|NCT01477567|B7|Baseline|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
170846|NCT01477567|B6|Baseline|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170847|NCT01477567|B5|Baseline|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170848|NCT01477567|B4|Baseline|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170849|NCT01477567|B3|Baseline|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170850|NCT01477567|B2|Baseline|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170851|NCT01477567|B1|Baseline|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170852|NCT01477567|P7|Participant Flow|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
170853|NCT01477567|P6|Participant Flow|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170854|NCT01477567|P5|Participant Flow|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170855|NCT01477567|P4|Participant Flow|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170856|NCT01477567|P3|Participant Flow|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170857|NCT01477567|P2|Participant Flow|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170864|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170865|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170866|NCT01477567|O5|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
170867|NCT01477567|O4|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170868|NCT01477567|O3|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170869|NCT01477567|O2|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170870|NCT01477567|O1|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170871|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
170872|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170873|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170874|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170875|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170876|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170877|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170878|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
170879|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170880|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170881|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170882|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170883|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170884|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170885|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170886|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170887|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170888|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170889|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170890|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170891|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170892|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170893|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170894|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170895|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170896|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170897|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
170898|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170899|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170900|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170901|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170902|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170903|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170904|NCT01477567|E7|Reported Event|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
170905|NCT01477567|E6|Reported Event|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170906|NCT01477567|E5|Reported Event|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170907|NCT01477567|E4|Reported Event|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170908|NCT01477567|E3|Reported Event|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170909|NCT01477567|E2|Reported Event|1 mg LY3009385|LY3009385: 1 milligram (mg), subcutaneous (SC) injection, single dose on Day 1
170910|NCT01477567|E1|Reported Event|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
170911|NCT01477463|B3|Baseline|Total|Total of all reporting groups
170912|NCT01477463|B2|Baseline|Arm B: Placebo|Placebo - subjects may cross over to vitamin D treatment after placebo treatment is complete
170913|NCT01477463|B1|Baseline|Arm A: Vitamin D|"4,000 IU oral vitamin D3
Vitamin D3: 4,000 IU oral vitamin D3"
170914|NCT01477463|P2|Participant Flow|Arm B: Placebo|Placebo - patients may cross over to vitamin D3 treatment after placebo treatment
170915|NCT01477463|P1|Participant Flow|Arm A: Vitamin D|"4,000 IU oral vitamin D3
Vitamin D3: 4,000 IU oral vitamin D3"
170917|NCT01477463|O1|Outcome|Arm A: Vitamin D|"4,000 IU oral vitamin D3
Vitamin D3: 4,000 IU oral vitamin D3"
170919|NCT01477463|O1|Outcome|Arm A: Vitamin D|"4,000 IU oral vitamin D3
Vitamin D3: 4,000 IU oral vitamin D3"
170920|NCT01477463|O1|Outcome|All Patients Treated With Vitamin D3|"4,000 IU oral vitamin D3
Vitamin D3: 4,000 IU oral vitamin D3"
170921|NCT01477463|O1|Outcome|All Patients Treated With Vitamin D3|"4,000 IU oral vitamin D3
Vitamin D3: 4,000 IU oral vitamin D3"
170922|NCT01477463|E2|Reported Event|Arm B: Placebo|Placebo (inactive capsule)
170923|NCT01477463|E1|Reported Event|Arm A: Vitamin D|"4,000 IU oral vitamin D3
Vitamin D3: 4,000 IU oral vitamin D3"
170924|NCT01477450|B4|Baseline|Total|Total of all reporting groups
170925|NCT01477450|B3|Baseline|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170926|NCT01477450|B2|Baseline|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170927|NCT01477450|B1|Baseline|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170928|NCT01477450|P3|Participant Flow|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170929|NCT01477450|P2|Participant Flow|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170930|NCT01477450|P1|Participant Flow|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170931|NCT01477450|O3|Outcome|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170932|NCT01477450|O2|Outcome|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170933|NCT01477450|O1|Outcome|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170934|NCT01477450|E3|Reported Event|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170935|NCT01477450|E2|Reported Event|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170936|NCT01477450|E1|Reported Event|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
170937|NCT01477333|B1|Baseline|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170938|NCT01477333|P1|Participant Flow|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170939|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170940|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170941|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170942|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170943|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170944|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170945|NCT01477333|O4|Outcome|Class III to Class III|UT-15C SR BID
170946|NCT01477333|O3|Outcome|Class III to Class II|UT-15C SR BID
170947|NCT01477333|O2|Outcome|Class II to Class III|UT-15C SR BID
170948|NCT01477333|O1|Outcome|Class II to Class II|UT-15C SR BID
170949|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170950|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170951|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170952|NCT01477333|E1|Reported Event|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
170953|NCT01475734|B3|Baseline|Total|Total of all reporting groups
170954|NCT01475734|B2|Baseline|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170955|NCT01475734|B1|Baseline|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
171067|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
192365|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
171109|NCT01475955|P4|Participant Flow|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
170956|NCT01475734|P2|Participant Flow|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170957|NCT01475734|P1|Participant Flow|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170958|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170959|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170960|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170961|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170962|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170963|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170964|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170965|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170966|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170967|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170968|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170969|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170970|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170971|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170972|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170973|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
171068|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171069|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
170974|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170975|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170976|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170977|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170978|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170979|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170980|NCT01475734|E2|Reported Event|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170981|NCT01475734|E1|Reported Event|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
170982|NCT01475721|B3|Baseline|Total|Total of all reporting groups
170983|NCT01475721|B2|Baseline|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170984|NCT01475721|B1|Baseline|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170985|NCT01475721|P2|Participant Flow|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170986|NCT01475721|P1|Participant Flow|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170987|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170988|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170989|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170990|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170991|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170992|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170993|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170994|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170995|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170996|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170997|NCT01475721|E2|Reported Event|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170998|NCT01475721|E1|Reported Event|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
170999|NCT01476748|B4|Baseline|Total|Total of all reporting groups
171000|NCT01476748|B3|Baseline|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171001|NCT01476748|B2|Baseline|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171002|NCT01476748|B1|Baseline|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171003|NCT01476748|P3|Participant Flow|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171004|NCT01476748|P2|Participant Flow|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171005|NCT01476748|P1|Participant Flow|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171006|NCT01476748|O3|Outcome|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171007|NCT01476748|O2|Outcome|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171008|NCT01476748|O1|Outcome|Covidien Versaport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171009|NCT01476748|O3|Outcome|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171010|NCT01476748|O2|Outcome|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171011|NCT01476748|O1|Outcome|Covidien Versaport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171012|NCT01476748|E3|Reported Event|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171013|NCT01476748|E2|Reported Event|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171014|NCT01476748|E1|Reported Event|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
171015|NCT01476722|B1|Baseline|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
171016|NCT01476722|P1|Participant Flow|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
171017|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
171018|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
171019|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
171020|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
171021|NCT01476722|E1|Reported Event|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
171022|NCT01476696|B1|Baseline|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.
Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
172769|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
171023|NCT01476696|P3|Participant Flow|Part A Then Part B: Prasugrel Single Dose Then Once-Daily Dose|"Participants who enrolled in Part A and B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.
Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition."
171024|NCT01476696|P2|Participant Flow|Part B: Prasugrel Once-Daily Dose|"Participants who only enrolled in Part B of the study.
Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel, administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
171025|NCT01476696|P1|Participant Flow|Part A: Prasugrel Single Dose|"Participants who only enrolled in Part A of the study.
Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses."
171026|NCT01476696|O1|Outcome|Part B: Prasugrel Once-Daily Dose|Part B: daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study.
171027|NCT01476696|O4|Outcome|Part B: Prasugrel Once-Daily Dose (0.12 mg/kg)|Participants who received 0.12 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
171028|NCT01476696|O3|Outcome|Part B: Prasugrel Once-Daily Dose (0.08 mg/kg)|Participants who received 0.08 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
171029|NCT01476696|O2|Outcome|Part B: Prasugrel Once-Daily Dose (0.06 mg/kg)|Participants who received 0.06 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
171030|NCT01476696|O1|Outcome|Part B: Baseline|Participants in Part B of the study, prior to receiving treatment (Prasugrel once-daily doses).
171031|NCT01476696|O1|Outcome|Part A: Prasugrel Single Dose|Part A of the study: 0.03 up to 0.60 milligrams per kilogram (mg/kg) Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses.
171032|NCT01476696|O1|Outcome|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.
Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
171033|NCT01476696|O1|Outcome|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.
Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
171070|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171071|NCT01476475|E2|Reported Event|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted (median exposure: 169 days).
171072|NCT01476475|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted (median exposure: 169 days).
171073|NCT01476345|B1|Baseline|All Participants|A single 0.5 units/kilogram (U/kg) dose of LY2963016 or a single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
171034|NCT01476696|E4|Reported Event|Part A and Part B Participants: During Part B|"Events reported during Part B for those participants who enrolled in Part A and Part B of study.
Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
171035|NCT01476696|E3|Reported Event|Part A and Part B Participants: During Part A|"Events reported during Part A for those participants who enrolled in Part A and Part B of study.
Part A: 0.03 mg/kg up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses."
171036|NCT01476696|E2|Reported Event|Part B: Prasugrel Once-Daily Dose|"Participants who only enrolled in Part B of the study.
Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
171037|NCT01476696|E1|Reported Event|Part A: Prasugrel Single Dose|"Participants who only enrolled in Part A of the study.
Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses."
171038|NCT01476475|B3|Baseline|Total|Total of all reporting groups
171039|NCT01476475|B2|Baseline|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171040|NCT01476475|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171041|NCT01476475|P2|Participant Flow|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171042|NCT01476475|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously once daily (QD) for 24 weeks. Dose individually adjusted.
171043|NCT01476475|O2|Outcome|Insulin Glargine (Lantus® SoloSTAR®)|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171044|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171045|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171046|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171047|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171048|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171049|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171050|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171051|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171052|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171053|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171054|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171055|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171056|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171057|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171058|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171059|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171060|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171061|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171062|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171063|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171064|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171065|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171066|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
171074|NCT01476345|P2|Participant Flow|Lantus/LY/Lantus/LY|"Sequence 2: A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 1 and 3.
A single 0.5 U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4.
Minimum washout interval of 7 days between each period."
171075|NCT01476345|P1|Participant Flow|LY/Lantus/LY/Lantus|"Sequence 1: A single 0.5 units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3.
A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 2 and 4.
Minimum washout interval of 7 days between each period."
171076|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
171077|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
171078|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
171079|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
171080|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
171081|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
171082|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
171083|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
171084|NCT01476345|E2|Reported Event|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
171085|NCT01476345|E1|Reported Event|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
171086|NCT01476202|B4|Baseline|Total|Total of all reporting groups
171087|NCT01476202|B3|Baseline|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
171088|NCT01476202|B2|Baseline|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
171089|NCT01476202|B1|Baseline|Nicotine Mouth Strip 2.5 mg|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
171090|NCT01476202|P3|Participant Flow|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine gum.
171091|NCT01476202|P2|Participant Flow|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
171092|NCT01476202|P1|Participant Flow|Nicotine Mouth Strip 2.5 Milligram (mg)|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
171093|NCT01476202|O3|Outcome|Nicotine Gum 2 mg|Participants self administered single dose of 2 mg nicotine gum.
171094|NCT01476202|O2|Outcome|Nicotine Lozenge 2 mg|Participants self administered single dose of 2 mg nicotine lozenge.
171095|NCT01476202|O1|Outcome|Nicotine Mouth Strip 2.5 Milligram (mg)|Participants self administered single dose of 2.5 mg nicotine mouth strip.
171096|NCT01476202|O3|Outcome|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine gum.
171097|NCT01476202|O2|Outcome|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
171098|NCT01476202|O1|Outcome|Nicotine Mouth Strip 2.5 mg|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
171099|NCT01476202|E3|Reported Event|Nicotine Gum 2 mg|Participants self administered single dose of 2 mg nicotine gum.
171100|NCT01476202|E2|Reported Event|Nicotine Lozenge 2 mg|Participants self administered single dose of 2 mg nicotine lozenge.
171101|NCT01476202|E1|Reported Event|Nicotine Mouth Strip 2.5 mg|Participants self administered single dose of 2.5 mg nicotine mouth strip.
171102|NCT01475955|B6|Baseline|Total|Total of all reporting groups
171103|NCT01475955|B5|Baseline|Vehicle (VEH) + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visit 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171104|NCT01475955|B4|Baseline|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
171105|NCT01475955|B3|Baseline|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
171106|NCT01475955|B2|Baseline|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
171107|NCT01475955|B1|Baseline|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
171108|NCT01475955|P5|Participant Flow|Vehicle + BLUE Light Treatment|"Vehicle (VEH) group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle (VEH) Photodynamic Therapy (PDT) : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171902|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
171110|NCT01475955|P3|Participant Flow|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171111|NCT01475955|P2|Participant Flow|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171112|NCT01475955|P1|Participant Flow|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5
171113|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171114|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171115|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171116|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171117|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171118|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171119|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171120|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171121|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171122|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171123|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171124|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171125|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171126|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171127|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171128|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171129|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171130|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171131|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171132|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171133|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171134|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171135|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171136|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171137|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171138|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171139|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171140|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171141|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171142|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171143|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171144|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171145|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171146|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171147|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171148|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171149|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171150|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171151|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171152|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171153|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171154|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171155|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171156|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171157|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171158|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
192366|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
171159|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171160|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171161|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171162|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171163|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171164|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171165|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171166|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171167|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171168|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171169|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171170|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171171|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171172|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171173|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171174|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171175|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171176|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171177|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171178|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171179|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171180|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171181|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171182|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171183|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
192367|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
171184|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171185|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171186|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171187|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171188|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171189|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171190|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171191|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171192|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171193|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171194|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171195|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171196|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171197|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171198|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171199|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171200|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171201|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171202|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171203|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171204|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171205|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171206|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171207|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171208|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
192368|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
171209|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171210|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171211|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171212|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171213|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171214|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171215|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171216|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171217|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171218|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171219|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171220|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171221|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171222|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171223|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171224|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171225|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171226|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171227|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171228|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171229|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171230|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171231|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171232|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171233|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
192369|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
171234|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171235|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171236|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171237|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171238|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171239|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171240|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171241|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171242|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171243|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171244|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171245|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171246|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171247|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171248|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171249|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171250|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171251|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171252|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171253|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171254|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171255|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171256|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171257|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171258|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
192370|NCT01401153|E2|Reported Event|Skipping Lunch|No lunch (water)
171259|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171260|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171261|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171262|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171263|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171264|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171265|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171266|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171267|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171268|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171269|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171270|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171271|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171272|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171273|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171274|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171275|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171276|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171277|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171278|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171279|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171280|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
171281|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171282|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171283|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
192371|NCT01401153|E1|Reported Event|Having Lunch|Lunch ad libitum
171284|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171285|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171286|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment at Visit 1 and Vi|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171287|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171288|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171289|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171290|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171291|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171292|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171293|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171294|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171295|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171296|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171297|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171298|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171299|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171300|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171301|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171302|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171303|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171304|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171305|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171306|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171307|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171308|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171309|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171310|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171311|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171312|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171313|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171314|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171315|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171316|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
171317|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171318|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171319|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171320|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171321|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171322|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171323|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171324|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171325|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171326|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171327|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171328|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171329|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171330|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171331|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171332|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171333|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
172770|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
171334|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171335|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171336|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171337|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171338|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171339|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171340|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171341|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171342|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171343|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171344|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171345|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171346|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171347|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171348|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171349|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171350|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171351|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171352|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171353|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171354|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171355|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171356|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171357|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171358|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171903|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
171359|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171360|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171361|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171362|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171363|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171364|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171365|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171366|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171367|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171368|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171369|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171370|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171371|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171372|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171373|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171374|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171375|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171376|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171377|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171378|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171379|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171380|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171381|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171382|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171383|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171904|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
171384|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171385|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171386|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171387|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171388|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171389|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171390|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171391|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171392|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171393|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171394|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171395|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171396|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171397|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171398|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171399|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171400|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171401|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171402|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171403|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5 . Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171404|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171405|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171406|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171407|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171408|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171905|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
171409|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171410|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171411|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Vist 1 and Visit 5
171412|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171413|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment, at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171414|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171415|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171416|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
171417|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
171418|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171419|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171420|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171421|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171422|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171423|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171424|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171425|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171426|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171427|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171428|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171429|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171430|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171431|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171432|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171433|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group were randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171906|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
171434|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171435|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171436|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171437|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171438|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171439|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171440|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171441|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171442|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171443|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. . Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171444|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171445|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171446|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171447|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171448|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171449|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171450|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171451|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation,prior to BLUE light treatment at Visits 1 and 5.
171452|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171453|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171454|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171455|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171456|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171457|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171458|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
171907|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
171459|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171460|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171461|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171462|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
171463|NCT01475955|E5|Reported Event|Vehicle PDT|"VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group."
171464|NCT01475955|E4|Reported Event|Spot ALA 2-hour|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation
171465|NCT01475955|E3|Reported Event|Broad Area ALA 3-hour|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation
171466|NCT01475955|E2|Reported Event|Broad Area ALA 2-hour|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation
171467|NCT01475955|E1|Reported Event|Broad Area ALA 1-hour|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation
171468|NCT01475851|B3|Baseline|Total|Total of all reporting groups
171469|NCT01475851|B2|Baseline|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171470|NCT01475851|B1|Baseline|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171471|NCT01475851|P2|Participant Flow|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171472|NCT01475851|P1|Participant Flow|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171473|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171474|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171475|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171476|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171477|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171478|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171479|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171480|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171481|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171482|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171483|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171484|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171485|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171486|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171487|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171488|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171489|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171490|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171491|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171492|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171493|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171494|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171495|NCT01475851|E2|Reported Event|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
171496|NCT01475851|E1|Reported Event|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
171497|NCT01475838|B3|Baseline|Total|Total of all reporting groups
171498|NCT01475838|B2|Baseline|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
171499|NCT01475838|B1|Baseline|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
171500|NCT01475838|P2|Participant Flow|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
171501|NCT01475838|P1|Participant Flow|Stribild|Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
171502|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
171503|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
171504|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
171505|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
171506|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
171507|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
171508|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
171509|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
171510|NCT01475838|E3|Reported Event|All Stribild|Adverse events for this reporting group include those occurring in participants while receiving Stribild in the randomized and extension phases.
171511|NCT01475838|E2|Reported Event|PI+RTV+FTC/TDF|"Adverse events for this reporting group include those occurring in participants receiving PI+RTV+FTC/TDF in the randomized phase.
Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase."
171512|NCT01475838|E1|Reported Event|Stribild|"Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase.
Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase."
171513|NCT01475487|B3|Baseline|Total|Total of all reporting groups
171514|NCT01475487|B2|Baseline|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy
Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy"
171515|NCT01475487|B1|Baseline|Cricothyrotomy Using Digital Palpation|"Group-1 will perform Cricothyrotomy using conventional digital palpation technique
Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy"
171525|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique
The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
171554|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171908|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
171555|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171516|NCT01475487|P2|Participant Flow|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.
The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
171517|NCT01475487|P1|Participant Flow|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique
The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
171518|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.
The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
171519|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique
The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
171520|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.
The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
171521|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique
The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
171522|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.
The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
171523|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique
The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
171524|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.
The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
171553|NCT01475461|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171909|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
171526|NCT01475487|E2|Reported Event|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.
The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
171527|NCT01475487|E1|Reported Event|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique
The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
171528|NCT01475474|B1|Baseline|Renew Insert for Management of Accidental Bowel Leakage|
171529|NCT01475474|P1|Participant Flow|Renew Insert for Management of Accidental Bowel Leakage|The Renew Insert is designed for self-insertion to seal and help prevent involuntary leakage of stool from the rectum. The Insert is designed for single use and consists of two components: a soft, easily deformable silicone insert and a flexible plastic fingertip applicator. After self insertion into the anal canal the Insert is expelled with voluntary bowel movement or if desired, manually removed by the user.
171530|NCT01475474|O1|Outcome|Modified Intent to Treat Cohort (MITT)|Modified Intent-to-Treat cohort included all subjects who completed at least one week of Insert use during the 12 Week Treatment Period.
171531|NCT01475474|O1|Outcome|Modified Intent-To-Treat Cohort|Modified Intent-to-Treat cohort included all subjects who completed week one and up to week 12 during the 12-Week Treatment Period.
171532|NCT01475474|E1|Reported Event|Intent-to-treat (ITT) Cohort|Subjects who used the Renew Insert.
171533|NCT01475461|B7|Baseline|Total|Total of all reporting groups
171534|NCT01475461|B6|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171535|NCT01475461|B5|Baseline|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171536|NCT01475461|B4|Baseline|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171537|NCT01475461|B3|Baseline|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171538|NCT01475461|B2|Baseline|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171539|NCT01475461|B1|Baseline|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171540|NCT01475461|P7|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171541|NCT01475461|P6|Participant Flow|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171542|NCT01475461|P5|Participant Flow|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171543|NCT01475461|P4|Participant Flow|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171544|NCT01475461|P3|Participant Flow|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171545|NCT01475461|P2|Participant Flow|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171546|NCT01475461|P1|Participant Flow|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
171547|NCT01475461|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171548|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171549|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171550|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171551|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171552|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171910|NCT01474681|O2|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
171556|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171557|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171558|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171559|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171560|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171561|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171562|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171563|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171564|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171565|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
171566|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171567|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171568|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171569|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171570|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171571|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171572|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
171573|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171574|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171575|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171576|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171577|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171578|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171579|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
171580|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171581|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171582|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171583|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171584|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171585|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
192372|NCT01401101|B3|Baseline|Total|Total of all reporting groups
171586|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171587|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171588|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171589|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171590|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171591|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171592|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171593|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171594|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171595|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171596|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171597|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171598|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171599|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171600|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171601|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171602|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171603|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171604|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171605|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171606|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171607|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171608|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171609|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171610|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171611|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171612|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171613|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171614|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171615|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171616|NCT01475461|E7|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171617|NCT01475461|E6|Reported Event|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171618|NCT01475461|E5|Reported Event|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171619|NCT01475461|E4|Reported Event|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171620|NCT01475461|E3|Reported Event|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
171621|NCT01475461|E2|Reported Event|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
171622|NCT01475461|E1|Reported Event|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
171623|NCT01475305|B3|Baseline|Total|Total of all reporting groups
171624|NCT01475305|B2|Baseline|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171625|NCT01475305|B1|Baseline|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171626|NCT01475305|P2|Participant Flow|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171627|NCT01475305|P1|Participant Flow|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171628|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171629|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171630|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171631|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171632|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171633|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171634|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171635|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171636|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171637|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171638|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171639|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171640|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171641|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171642|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171643|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171644|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171645|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171646|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171647|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171648|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
172771|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
171649|NCT01475305|O1|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171650|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171651|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171652|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171653|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171654|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171655|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171656|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171657|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171658|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171659|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171660|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171661|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171662|NCT01475305|O2|Outcome|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171663|NCT01475305|O1|Outcome|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171664|NCT01475305|E2|Reported Event|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
171665|NCT01475305|E1|Reported Event|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
171666|NCT01475253|B4|Baseline|Total|Total of all reporting groups
171667|NCT01475253|B3|Baseline|Sham Cystoscopic Procedure-Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
171668|NCT01475253|B2|Baseline|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171669|NCT01475253|B1|Baseline|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171670|NCT01475253|P4|Participant Flow|LiRIS® 400 mg - Open Label Extension|LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine. All subjects who completed the randomized study had the option to enter the open label extension.
171671|NCT01475253|P3|Participant Flow|Sham Cystoscopic Procedure-Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
171672|NCT01475253|P2|Participant Flow|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171673|NCT01475253|P1|Participant Flow|LiRIS® 400 mg - Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171674|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171675|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171676|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171911|NCT01474681|O1|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
192966|NCT01398943|B1|Baseline|All COPD Patients|Patients with COPD
171918|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
171677|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171678|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171679|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171680|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171681|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171682|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171683|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171684|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171685|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171686|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171687|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171688|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171689|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171690|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171691|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171692|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171693|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171694|NCT01475253|E4|Reported Event|LiRIS 400 mg - Open Label Extension|"LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine.
All subjects who completed the randomized study had the option to enter the open lable extension."
171695|NCT01475253|E3|Reported Event|Sham Cystoscopic Procedure - Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
171696|NCT01475253|E2|Reported Event|LiRIS® Placebo - Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171697|NCT01475253|E1|Reported Event|LiRIS® 400 mg - Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
171698|NCT01475214|B4|Baseline|Total|Total of all reporting groups
171699|NCT01475214|B3|Baseline|Inactive Placebo Capsule|"microcrystalline cellulose
placebo: microcrystalline cellulose"
171700|NCT01475214|B2|Baseline|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
172772|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
171701|NCT01475214|B1|Baseline|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
171702|NCT01475214|P3|Participant Flow|Inactive Capsule|"microcrystalline cellulose
placebo: microcrystalline cellulose"
171703|NCT01475214|P2|Participant Flow|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
171704|NCT01475214|P1|Participant Flow|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
171705|NCT01475214|O3|Outcome|Inactive Capsule|"microcrystalline cellulose
placebo: microcrystalline cellulose"
171706|NCT01475214|O2|Outcome|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
171707|NCT01475214|O1|Outcome|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
171708|NCT01475214|O3|Outcome|Inactive Placebo Capsule|"microcrystalline cellulose
placebo: microcrystalline cellulose"
171709|NCT01475214|O2|Outcome|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
171710|NCT01475214|O1|Outcome|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
171711|NCT01475214|E3|Reported Event|Inactive Capsule|"microcrystalline cellulose
placebo: microcrystalline cellulose"
171712|NCT01475214|E2|Reported Event|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
171713|NCT01475214|E1|Reported Event|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
171714|NCT01475175|B1|Baseline|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171715|NCT01475175|P1|Participant Flow|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171716|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171717|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171718|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171719|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171720|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171721|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171722|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171723|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171724|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171725|NCT01475175|E1|Reported Event|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
171726|NCT01475097|B3|Baseline|Total|Total of all reporting groups
171727|NCT01475097|B2|Baseline|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
171728|NCT01475097|B1|Baseline|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
171729|NCT01475097|P2|Participant Flow|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
171730|NCT01475097|P1|Participant Flow|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
171731|NCT01475097|O2|Outcome|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
171732|NCT01475097|O1|Outcome|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
171733|NCT01475097|O2|Outcome|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
171734|NCT01475097|O1|Outcome|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
171735|NCT01475097|E2|Reported Event|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
171736|NCT01475097|E1|Reported Event|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
171737|NCT01475071|B1|Baseline|All Subjects Enrolled|Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side
171912|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
171738|NCT01475071|P1|Participant Flow|All Subjects Enrolled|Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side
171739|NCT01475071|O2|Outcome|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
171740|NCT01475071|O1|Outcome|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
171741|NCT01475071|O2|Outcome|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
171742|NCT01475071|O1|Outcome|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
171743|NCT01475071|E2|Reported Event|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
171744|NCT01475071|E1|Reported Event|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
171745|NCT01474993|B3|Baseline|Total|Total of all reporting groups
171746|NCT01474993|B2|Baseline|Sulforaphane-rich Broccoli Sprout Extract|29 subjects were randomized to receive sulforaphane.
171747|NCT01474993|B1|Baseline|Placebo|15 participants were randomized to placebo.
171748|NCT01474993|P2|Participant Flow|Sulforaphane-rich Broccoli Sprout Extract|"29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study.
Sulforaphane-rich Broccoli Sprout Extract: The medication was supplied and dispensed as No.1 size gelcaps (each gelcap containing ~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of sulforaphane). The dosage of sulforaphane depended on subject's body weight:
Subjects with body weight less than 101 lbs will receive ~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day)
Subjects with body weight 101 lbs to 199 lbs will receive ~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day)
Subjects with bidy weight > 199 lbs will receive ~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)"
171749|NCT01474993|P1|Participant Flow|Placebo|15 participants were randomized to placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose).One participant in placebo group dropped out before starting study drug. 14 participants completed the study.
171750|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171751|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171752|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171753|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171754|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171755|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171756|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171913|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
171914|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
171757|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171758|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171759|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171760|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171761|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171762|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171763|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171764|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171765|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171766|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171767|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171915|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
171916|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
171768|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient’s body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 – 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171769|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient’s body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 – 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
171770|NCT01474993|E2|Reported Event|Sulforaphane-rich Broccoli Sprout Extract|29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study and were analyzed.
171771|NCT01474993|E1|Reported Event|Placebo|15 participants were randomized to placebo. One participant in placebo group dropped out before starting study drug. 14 participants completed the study and were analyzed.
171772|NCT01474915|B3|Baseline|Total|Total of all reporting groups
171773|NCT01474915|B2|Baseline|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.
Triple therapy
4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction
Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
171774|NCT01474915|B1|Baseline|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.
Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction
Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
171775|NCT01474915|P2|Participant Flow|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.
Triple therapy
4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction
Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
171776|NCT01474915|P1|Participant Flow|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.
Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction
Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
171777|NCT01474915|O2|Outcome|Ondansetron|"Ondansetron is given via intravenous (IV), along with an oral (PO) or IV placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.
Triple therapy
4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction
Ondansetron : Subject receives 4 mg of Ondansetron IV versus placebo around anesthesia induction
Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
171778|NCT01474915|O1|Outcome|Aprepitant|"Aprepitant is given orally (PO), along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an intravenous (IV) or oral placebo prior to induction of anesthesia.
Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Aprepitant : Subject receives 40 mg of Aprepitant versus placebo PO before anesthesia induction
Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction
Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
171779|NCT01474915|O2|Outcome|Ondansetron|"Ondansetron is given via intravenous (IV), along with an oral (PO) or IV placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.
Triple therapy
4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction
Ondansetron : Subject receives 4 mg of Ondansetron IV versus placebo around anesthesia induction
Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
171822|NCT01474863|B1|Baseline|Low Dose Citrulline|"Low Dose Citrulline
Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
171917|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
171780|NCT01474915|O1|Outcome|Aprepitant|"Aprepitant is given orally (PO), along with an oral or PO placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication plus an intravenous (IV) or oral placebo prior to induction of anesthesia.
Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Aprepitant : Subject receives 40 mg of Aprepitant versus placebo PO before anesthesia induction
Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction
Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
171781|NCT01474915|E2|Reported Event|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.
Triple therapy
4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction
Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
171782|NCT01474915|E1|Reported Event|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.
Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction
Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
171783|NCT01474876|B4|Baseline|Total|Total of all reporting groups
171784|NCT01474876|B3|Baseline|Disease State Unknown|For one participant, information regarding the underlying disease was not available
171785|NCT01474876|B2|Baseline|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171786|NCT01474876|B1|Baseline|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171787|NCT01474876|P3|Participant Flow|Disease State Unknown|For one participant, information regarding the underlying disease was not available
171788|NCT01474876|P2|Participant Flow|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171789|NCT01474876|P1|Participant Flow|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171790|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171791|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171792|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171793|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171794|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171795|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171796|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171797|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171798|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171799|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171800|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171801|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171802|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171803|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171804|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171805|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171806|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171807|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171808|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171809|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171810|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171811|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171812|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171813|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171814|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171815|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171816|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
171817|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
171818|NCT01474876|E1|Reported Event|Overall Study Population|Participants who received adalimumab treatment
171819|NCT01474863|B4|Baseline|Total|Total of all reporting groups
171820|NCT01474863|B3|Baseline|High Dose Citrulline|"High Dose Citrulline
High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
171821|NCT01474863|B2|Baseline|Placebo|"Placebo IV infusion
Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
171894|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
171895|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
171823|NCT01474863|P3|Participant Flow|High Dose Citrulline|"High Dose Citrulline
High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
171824|NCT01474863|P2|Participant Flow|Placebo|"Placebo IV infusion
Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
171825|NCT01474863|P1|Participant Flow|Low Dose Citrulline|"Low Dose Citrulline
Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
171826|NCT01474863|O3|Outcome|High Dose Citrulline|"High Dose Citrulline
High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
171827|NCT01474863|O2|Outcome|Placebo|"Placebo IV infusion
Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
171828|NCT01474863|O1|Outcome|Low Dose Citrulline|"Low Dose Citrulline
Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
171829|NCT01474863|E3|Reported Event|High Dose Citrulline|"High Dose Citrulline
High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
171830|NCT01474863|E2|Reported Event|Placebo|"Placebo IV infusion
Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
171831|NCT01474863|E1|Reported Event|Low Dose Citrulline|"Low Dose Citrulline
Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
171832|NCT01474772|B3|Baseline|Total|Total of all reporting groups
171833|NCT01474772|B2|Baseline|Placebo/Pregabalin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171834|NCT01474772|B1|Baseline|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171835|NCT01474772|P2|Participant Flow|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171836|NCT01474772|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171837|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171838|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171839|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171840|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171841|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171842|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171843|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171844|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171845|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171846|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171847|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171848|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171849|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171850|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171851|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171896|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
171897|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
171852|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171853|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171854|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171855|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171856|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171857|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171858|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171859|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171860|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171861|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171862|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171898|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
171899|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
171863|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171864|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171865|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171866|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171867|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171868|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171869|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171870|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171871|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171872|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171873|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171900|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
171901|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
171874|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171875|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171876|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171877|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171878|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171879|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171880|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171881|NCT01474772|E2|Reported Event|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171882|NCT01474772|E1|Reported Event|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
171883|NCT01474681|B3|Baseline|Total|Total of all reporting groups
171884|NCT01474681|B2|Baseline|DUCBT|Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT<18 yrs and DUCBT >= 18 yrs
171885|NCT01474681|B1|Baseline|SUCBT|Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT<18 yrs and SUCBT >= 18 yrs
171886|NCT01474681|P4|Participant Flow|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
171887|NCT01474681|P3|Participant Flow|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
171888|NCT01474681|P2|Participant Flow|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
171889|NCT01474681|P1|Participant Flow|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
171890|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
171891|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
171892|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
171893|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
171919|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
171920|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
171921|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
171922|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
171923|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
171924|NCT01474681|E6|Reported Event|DUCBT|Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT<18 yrs and DUCBT >= 18 yrs
171925|NCT01474681|E5|Reported Event|SUCBT|Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT<18 yrs and SUCBT >= 18 yrs
171926|NCT01474681|E4|Reported Event|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
171927|NCT01474681|E3|Reported Event|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
171928|NCT01474681|E2|Reported Event|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
171929|NCT01474681|E1|Reported Event|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
171930|NCT01474590|B3|Baseline|Total|Total of all reporting groups
171931|NCT01474590|B2|Baseline|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
171932|NCT01474590|B1|Baseline|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
171933|NCT01474590|P2|Participant Flow|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
171934|NCT01474590|P1|Participant Flow|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
171935|NCT01474590|O2|Outcome|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
171936|NCT01474590|O1|Outcome|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
171937|NCT01474590|E2|Reported Event|Isotretinoin + Vehicle Gel|Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
171938|NCT01474590|E1|Reported Event|Epiduo/Tactuo + Doxycycline 200mg|Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
171939|NCT01474551|B1|Baseline|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.
Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
171940|NCT01474551|P1|Participant Flow|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.
Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
171941|NCT01474551|O1|Outcome|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.
Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
171942|NCT01474551|E1|Reported Event|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.
Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
171943|NCT01474538|B3|Baseline|Total|Total of all reporting groups
171944|NCT01474538|B2|Baseline|Insulin Aspart / Insulin Lispro|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
171945|NCT01474538|B1|Baseline|Insulin Lispro / Insulin Aspart|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
171946|NCT01474538|P2|Participant Flow|Insulin Aspart / Insulin Lispro|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
171947|NCT01474538|P1|Participant Flow|Insulin Lispro / Insulin Aspart|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
171948|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
172274|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
172293|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily"
171949|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
171950|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
171951|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
171952|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
171953|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
171954|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
171955|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
171956|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
171957|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
171958|NCT01474538|E2|Reported Event|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
171959|NCT01474538|E1|Reported Event|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
171960|NCT01474512|B4|Baseline|Total|Total of all reporting groups
171961|NCT01474512|B3|Baseline|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Week 10.
171962|NCT01474512|B2|Baseline|Ixe Q4W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W.
171963|NCT01474512|B1|Baseline|Placebo|Placebo administered as 2 SC injections Q2W up to Week 10.
171964|NCT01474512|P10|Participant Flow|Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
171965|NCT01474512|P9|Participant Flow|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
171966|NCT01474512|P8|Participant Flow|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
171967|NCT01474512|P7|Participant Flow|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
171968|NCT01474512|P6|Participant Flow|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
171969|NCT01474512|P5|Participant Flow|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56.
171970|NCT01474512|P4|Participant Flow|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
171971|NCT01474512|P3|Participant Flow|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 4, 6, 8, and 10.
171972|NCT01474512|P2|Participant Flow|Ixe Q4W - Induction Period|160 milligrams (mg) ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
171973|NCT01474512|P1|Participant Flow|Placebo- Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up to Week 10.
171974|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
171975|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
171976|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
171977|NCT01474512|O4|Outcome|Ixe Q12W - Maintenance Period|80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
171978|NCT01474512|O3|Outcome|Ixe Q4W - Maintenance Period|80 mg ixe administered as 1 SC injection Q4W from Week 12 up to Week 60
171979|NCT01474512|O2|Outcome|Ixe Q4W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
171980|NCT01474512|O1|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
171981|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
171982|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
171983|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
172275|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
171984|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
171985|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
171986|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
171987|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
171988|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
171989|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
171990|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
171991|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
171992|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
171993|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
171994|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
171995|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
171996|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
171997|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
171998|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
171999|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
172000|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
172001|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
172002|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
172003|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
172004|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
172005|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
172006|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
172007|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
172008|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
172009|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
172010|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
172011|NCT01474512|O3|Outcome|Ixe/Q4W|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
172012|NCT01474512|O2|Outcome|Ixe/Q12W|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56 (Maintenance Period).
172013|NCT01474512|O1|Outcome|Ixe/Placebo|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
172014|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
172015|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
172016|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
172017|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
172018|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
172019|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
172020|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
172021|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
172022|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
172023|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
172024|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
172025|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
172026|NCT01474512|E11|Reported Event|Ixe Q4W - Maintenance Period Relapse Pop|Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
172276|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
193664|NCT01396187|B6|Baseline|Total|Total of all reporting groups
172027|NCT01474512|E10|Reported Event|Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
172028|NCT01474512|E9|Reported Event|Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
172029|NCT01474512|E8|Reported Event|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
172030|NCT01474512|E7|Reported Event|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
172031|NCT01474512|E6|Reported Event|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
172032|NCT01474512|E5|Reported Event|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56.
172033|NCT01474512|E4|Reported Event|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
172034|NCT01474512|E3|Reported Event|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Weeks 4, 6, 8 and 10.
172035|NCT01474512|E2|Reported Event|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W. Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
172036|NCT01474512|E1|Reported Event|Placebo - Induction Period|Placebo was administered as 2 SC injections Q2W up to Week 10.
172037|NCT01474434|B5|Baseline|Total|Total of all reporting groups
172038|NCT01474434|B4|Baseline|Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
172039|NCT01474434|B3|Baseline|Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
172040|NCT01474434|B2|Baseline|Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
172041|NCT01474434|B1|Baseline|Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
172042|NCT01474434|P4|Participant Flow|Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
172043|NCT01474434|P3|Participant Flow|Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
172044|NCT01474434|P2|Participant Flow|Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
172045|NCT01474434|P1|Participant Flow|Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
172046|NCT01474434|O2|Outcome|Part B: Placebo|
172047|NCT01474434|O1|Outcome|Part B: Pradigastat (LCQ908)|
172277|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
194349|NCT01393743|B3|Baseline|Total|Total of all reporting groups
172048|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172049|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
172050|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172051|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
172052|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172053|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
172054|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172055|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
172056|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172057|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
172058|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172059|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
172060|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172061|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
172062|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172063|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
172064|NCT01474434|O2|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172065|NCT01474434|O1|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
172066|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172067|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
172068|NCT01474434|O2|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172069|NCT01474434|O1|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
172070|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172278|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
172279|NCT01474122|E3|Reported Event|Placebo|Patients received placebo once daily.
172071|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
172072|NCT01474434|O2|Outcome|Part B: Placebo|
172073|NCT01474434|O1|Outcome|Part B: Pradigastat (LCQ908)|
172074|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172075|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
172076|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172077|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
172078|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172079|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
172080|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172081|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
172082|NCT01474434|E4|Reported Event|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172083|NCT01474434|E3|Reported Event|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
172084|NCT01474434|E2|Reported Event|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
172085|NCT01474434|E1|Reported Event|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
172086|NCT01474317|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study
G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
172087|NCT01474317|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system.
G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
172088|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.
G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
172089|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.
G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
172090|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.
G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
172773|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
172091|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.
G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
172092|NCT01474317|E1|Reported Event|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.
G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
172093|NCT01474291|B3|Baseline|Total|Total of all reporting groups
172094|NCT01474291|B2|Baseline|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172095|NCT01474291|B1|Baseline|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172096|NCT01474291|P1|Participant Flow|All Tocilizumab|Tocilizumab (RoActemra/Actemra) administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172097|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172098|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172099|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172100|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172101|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172102|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172103|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172104|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172105|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172106|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172107|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172108|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172109|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172110|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172111|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172112|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172113|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172114|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172115|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172116|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172117|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172118|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172119|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172120|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172121|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172122|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172123|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172124|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172125|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172126|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172127|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172128|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172129|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172130|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172131|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172132|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172133|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172134|NCT01474291|O1|Outcome|All Tocilizumab|Tocilizumab administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172135|NCT01474291|E2|Reported Event|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
172136|NCT01474291|E1|Reported Event|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
172137|NCT01474239|B3|Baseline|Total|Total of all reporting groups
172138|NCT01474239|B2|Baseline|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172139|NCT01474239|B1|Baseline|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172140|NCT01474239|P2|Participant Flow|Fotemustine|Participants received fotemustine 75 milligrams per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172141|NCT01474239|P1|Participant Flow|Bevacizumab|Participants received bevacizumab 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172142|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172143|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172144|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172145|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172146|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172147|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172148|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172149|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172150|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172151|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172152|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172153|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172280|NCT01474122|E2|Reported Event|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
172154|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172155|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172156|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172157|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172158|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172159|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172160|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172161|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172162|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172163|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172164|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172165|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172166|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172167|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172168|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172169|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172170|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172171|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172172|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172173|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172174|NCT01474239|E2|Reported Event|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172175|NCT01474239|E1|Reported Event|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
172176|NCT01474213|B3|Baseline|Total|Total of all reporting groups
172177|NCT01474213|B2|Baseline|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
172178|NCT01474213|B1|Baseline|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
172179|NCT01474213|P2|Participant Flow|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
172180|NCT01474213|P1|Participant Flow|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
172181|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
172182|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
172183|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
172184|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
172185|NCT01474213|O2|Outcome|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
172186|NCT01474213|O1|Outcome|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site (had equilibrated with the plasma concentration, until the desired level of sedation was reached.
172187|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Three patients in dexmedetomidine group exhibited bradycardia(heart rate<50beats per minute) during endoscopy and intubation period.
172188|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Two patients in remifentanil group exhibited bradycardia(heart rate<50beats per minute) during endoscopy and intubation period.
172189|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
172190|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
172191|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
172192|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
172193|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
172194|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
172195|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
172196|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
172197|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
172198|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
172199|NCT01474213|E2|Reported Event|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
172200|NCT01474213|E1|Reported Event|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
172201|NCT01474200|B3|Baseline|Total|Total of all reporting groups
172202|NCT01474200|B2|Baseline|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172203|NCT01474200|B1|Baseline|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172204|NCT01474200|P2|Participant Flow|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172205|NCT01474200|P1|Participant Flow|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172206|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172207|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172208|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172209|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172210|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172211|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172212|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172281|NCT01474122|E1|Reported Event|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
172282|NCT01474109|B4|Baseline|Total|Total of all reporting groups
172283|NCT01474109|B3|Baseline|Placebo|"matching placebo once daily
placebo: matching placebo once daily"
172213|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172214|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172215|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172216|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172217|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172218|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172219|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172220|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172221|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172222|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172223|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172284|NCT01474109|B2|Baseline|Macitentan 10mg|"macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily"
172285|NCT01474109|B1|Baseline|Macitentan 3mg|"macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily"
172286|NCT01474109|P3|Participant Flow|Placebo|"matching placebo once daily
placebo: matching placebo once daily"
172224|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172225|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172226|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172227|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172228|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172229|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172230|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172231|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172232|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172233|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172234|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172287|NCT01474109|P2|Participant Flow|Macitentan 10mg|"macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily"
172288|NCT01474109|P1|Participant Flow|Macitentan 3mg|"macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily"
194580|NCT01393132|B3|Baseline|Total|Total of all reporting groups
172235|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172236|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172237|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172238|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172239|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172240|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172241|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172242|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172243|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172244|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172245|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172289|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily
placebo: matching placebo once daily"
172290|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily"
172291|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily"
172246|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172247|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172248|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172249|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172250|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172251|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172252|NCT01474200|E2|Reported Event|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
172253|NCT01474200|E1|Reported Event|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
172254|NCT01474122|B4|Baseline|Total|Total of all reporting groups
172255|NCT01474122|B3|Baseline|Placebo|Patients received placebo once daily.
172256|NCT01474122|B2|Baseline|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
172257|NCT01474122|B1|Baseline|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
172258|NCT01474122|P3|Participant Flow|Placebo|Patients received placebo once daily.
172259|NCT01474122|P2|Participant Flow|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
172260|NCT01474122|P1|Participant Flow|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
172261|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
172262|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
172263|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
172264|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
172265|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
172266|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
172267|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
172268|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
172269|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
172270|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
172271|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan 10mg once daily.
172272|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan 3mg once daily.
172273|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
196294|NCT01388816|O1|Outcome|DRL-17822 50 mg|Once daily after breakfast
172294|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily"
172295|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily
placebo: matching placebo once daily"
172296|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily"
172297|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily"
172298|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily
placebo: matching placebo once daily"
172299|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily"
172300|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily"
172301|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily
placebo: matching placebo once daily"
172302|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily"
172303|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily"
172304|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily
placebo: matching placebo once daily"
172305|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily"
172306|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily"
172307|NCT01474109|E3|Reported Event|Placebo|"matching placebo once daily
placebo: matching placebo once daily"
172308|NCT01474109|E2|Reported Event|Macitentan 10mg|"macitentan 10mg tablet once daily
macitentan 10mg: macitentan 10mg tablet once daily"
172309|NCT01474109|E1|Reported Event|Macitentan 3mg|"macitentan 3mg tablet once daily
macitentan 3mg: macitentan 3mg tablet once daily"
172310|NCT01473992|B3|Baseline|Total|Total of all reporting groups
172311|NCT01473992|B2|Baseline|Non Amputee Control Group|non-amputee healty controls
172312|NCT01473992|B1|Baseline|Entire Study Population|Includes groups randomized to receive Otto Bock C-Leg (prosthetic knee 1), amputees' preferred prosthetic knee, first and Otto Bock Genium (prosthetic knee 2), the study knee, first.
172313|NCT01473992|P3|Participant Flow|Control (Non-amputees)|Non-amputee control group
172314|NCT01473992|P2|Participant Flow|Prosthetic Knee 2 Then Prosthetic Knee 1|Experimental knee (Otto Bock Genium: Study knee) then subjects' preferred knee (C-Leg).
172315|NCT01473992|P1|Participant Flow|Prosthetic Knee 1 Then Prosthetic Knee 2|Otto Bock C-Leg: Amputees' preferred prosthetic knee then experimental knee (Genium).
172316|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee control group
172317|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
172318|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
172319|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
172320|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
172321|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee controls
172322|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
172323|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
172324|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee controls
172325|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
172326|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
172327|NCT01473992|E2|Reported Event|Prosthetic Knee 2|Otto Bock Genium: Study knee.
172328|NCT01473992|E1|Reported Event|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
172329|NCT01473953|B6|Baseline|Total|Total of all reporting groups
172330|NCT01473953|B5|Baseline|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
172331|NCT01473953|B4|Baseline|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
172332|NCT01473953|B3|Baseline|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
172333|NCT01473953|B2|Baseline|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
172334|NCT01473953|B1|Baseline|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
172335|NCT01473953|P5|Participant Flow|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
172336|NCT01473953|P4|Participant Flow|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
172337|NCT01473953|P3|Participant Flow|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
172338|NCT01473953|P2|Participant Flow|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
172339|NCT01473953|P1|Participant Flow|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
172340|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
172341|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
172342|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
172343|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
172344|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
172345|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
196295|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
172346|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
172347|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
172348|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
172349|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
172350|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
172351|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
172352|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
172353|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
172354|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
172355|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
172356|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
172357|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
172358|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
172359|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
172360|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
172361|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
172362|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
172363|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
172364|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
172365|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
172366|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
172367|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
172368|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
172369|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
172370|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
172371|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
172372|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
172373|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
172374|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
172375|NCT01473953|E5|Reported Event|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
172376|NCT01473953|E4|Reported Event|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
172377|NCT01473953|E3|Reported Event|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
172378|NCT01473953|E2|Reported Event|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
172379|NCT01473953|E1|Reported Event|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
172380|NCT01473836|B1|Baseline|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
172381|NCT01473836|P1|Participant Flow|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
172382|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
172383|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
172413|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172774|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
172384|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
172385|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
172386|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
172387|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
172388|NCT01473836|E1|Reported Event|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
172389|NCT01473758|B3|Baseline|Total|Total of all reporting groups
172390|NCT01473758|B2|Baseline|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172391|NCT01473758|B1|Baseline|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172392|NCT01473758|P4|Participant Flow|Placebo (Cycle 2)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.
172393|NCT01473758|P3|Participant Flow|Roflumilast 500 µg (Cycle 2)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.
172394|NCT01473758|P2|Participant Flow|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.
172395|NCT01473758|P1|Participant Flow|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.
172396|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172397|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172398|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172399|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172400|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172401|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172402|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172403|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172404|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172405|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172406|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172407|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172408|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172409|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172410|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172411|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172412|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172414|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172415|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172416|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172417|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172418|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172419|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172420|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172421|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172422|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172423|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172424|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172425|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172426|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172427|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172428|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172429|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172430|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172431|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172432|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172433|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172434|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172435|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172436|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172437|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172438|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172439|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172440|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172441|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172442|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172443|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172444|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172445|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172446|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172447|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172448|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172664|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
172449|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172450|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172451|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172452|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172453|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172454|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172455|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172456|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172457|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172458|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172459|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172460|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172461|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172462|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172463|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172464|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172465|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172466|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172467|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172468|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172469|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172470|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172471|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172472|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172473|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172474|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172475|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172476|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172477|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172478|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172479|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172480|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172481|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172482|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172483|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172766|NCT01472939|P1|Participant Flow|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
172484|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172485|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172486|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172487|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172488|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172489|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172490|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172491|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172492|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172493|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172494|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172495|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172496|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172497|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172498|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172499|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172500|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172501|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172502|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172503|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172504|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172505|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172506|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172507|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172508|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172509|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172510|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172511|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
172512|NCT01473758|E4|Reported Event|Placebo (Extended Approach)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.
172513|NCT01473758|E3|Reported Event|Roflumilast 500 µg (Extended Approach)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.
172514|NCT01473758|E2|Reported Event|Placebo (Initial Approach)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.
172515|NCT01473758|E1|Reported Event|Roflumilast 500 μg (Initial Approach)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.
172516|NCT01473745|B3|Baseline|Total|Total of all reporting groups
172593|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172517|NCT01473745|B2|Baseline|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally
conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
172518|NCT01473745|B1|Baseline|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side
modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
172519|NCT01473745|P2|Participant Flow|Modified Alar Cinch Group|Patients received modified alar base cinch technique during LeFort I osteotomy procedure.
172520|NCT01473745|P1|Participant Flow|Conventional Alar Cinch Group|Patients received conventional alar base cinch technique during LeFort I osteotomy procedure.
172521|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally
conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
172522|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side
modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
172523|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally
conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
172524|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side
modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
172525|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally
conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
172526|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side
modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
172527|NCT01473745|E2|Reported Event|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) and nasalis muscle intra-orally
conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
172528|NCT01473745|E1|Reported Event|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from not only ANS and nasalis muscle, but also through the dermis layer of the alar base.
modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
172529|NCT01473602|B3|Baseline|Total|Total of all reporting groups
172530|NCT01473602|B2|Baseline|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172531|NCT01473602|B1|Baseline|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172532|NCT01473602|P2|Participant Flow|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172533|NCT01473602|P1|Participant Flow|Teriparatide|Teriparatide 20 microgram (µg) once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172534|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172535|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172536|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172537|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172538|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172539|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172540|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172541|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172542|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172543|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172544|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172545|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172546|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172547|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172548|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172549|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172550|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172767|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
172551|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172552|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172553|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172554|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172555|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172556|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172557|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172558|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172559|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172560|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172561|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172562|NCT01473602|E4|Reported Event|Teriparatide Follow-up|Follow-up after teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172563|NCT01473602|E3|Reported Event|Placebo Follow-up|Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172564|NCT01473602|E2|Reported Event|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172565|NCT01473602|E1|Reported Event|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172566|NCT01473589|B3|Baseline|Total|Total of all reporting groups
172567|NCT01473589|B2|Baseline|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172568|NCT01473589|B1|Baseline|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172569|NCT01473589|P2|Participant Flow|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172570|NCT01473589|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
172571|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172572|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172573|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172574|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172575|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172576|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172577|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172578|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172579|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172580|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172581|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172582|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172583|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172584|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172585|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172586|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172587|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172588|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172589|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172590|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172591|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172592|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172594|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172595|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172596|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172597|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172598|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172599|NCT01473589|E4|Reported Event|Teriparatide Follow-up|Follow-up after teriparatide 20 µg once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172600|NCT01473589|E3|Reported Event|Placebo Follow-up|Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172601|NCT01473589|E2|Reported Event|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172602|NCT01473589|E1|Reported Event|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
172603|NCT01473563|B1|Baseline|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172604|NCT01473563|P1|Participant Flow|Pemetrexed|Pemetrexed: 500 milligrams per meter squared (mg/m^2) administered as an intravenous (IV) infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172605|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172606|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172607|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172608|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172609|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172610|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172611|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172612|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172613|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172614|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172615|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172616|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172639|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172617|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172618|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172619|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172620|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172621|NCT01473563|E1|Reported Event|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
172622|NCT01473524|B4|Baseline|Total|Total of all reporting groups
172623|NCT01473524|B3|Baseline|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172624|NCT01473524|B2|Baseline|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172625|NCT01473524|B1|Baseline|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.
After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
172626|NCT01473524|P3|Participant Flow|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172627|NCT01473524|P2|Participant Flow|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172628|NCT01473524|P1|Participant Flow|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.
After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
172629|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172630|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172631|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.
After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
172632|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172633|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172634|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double blind-period.
After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
172635|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172636|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172637|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.
After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
172638|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
196296|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
172640|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.
After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
172641|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172642|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172643|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.
After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
172644|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172645|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172646|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.
After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
172647|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172648|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.
After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
172649|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172650|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.
After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
172651|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172652|NCT01473524|O1|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172653|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172654|NCT01473524|O1|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172655|NCT01473524|E3|Reported Event|Placebo|One tablet daily for double-blind period. After completion of the 1 year double-blind period period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172656|NCT01473524|E2|Reported Event|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1 year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
172657|NCT01473524|E1|Reported Event|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double blind-period.
After completion of the 1 year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
172658|NCT01473394|B3|Baseline|Total|Total of all reporting groups
172659|NCT01473394|B2|Baseline|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
172660|NCT01473394|B1|Baseline|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
172661|NCT01473394|P2|Participant Flow|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
172662|NCT01473394|P1|Participant Flow|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
172663|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
196297|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
172665|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
172666|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
172667|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
172668|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
172669|NCT01473394|E2|Reported Event|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
172670|NCT01473394|E1|Reported Event|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
172671|NCT01473381|B5|Baseline|Total|Total of all reporting groups
172672|NCT01473381|B4|Baseline|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
172673|NCT01473381|B3|Baseline|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
172674|NCT01473381|B2|Baseline|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
172675|NCT01473381|B1|Baseline|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
172676|NCT01473381|P4|Participant Flow|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
172677|NCT01473381|P3|Participant Flow|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
172678|NCT01473381|P2|Participant Flow|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
172679|NCT01473381|P1|Participant Flow|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
172680|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
172681|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days
172682|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
172683|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
172684|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
172685|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
172686|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
172687|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
172716|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate) During Treatment|"During treatment
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
172688|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
172689|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
172690|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
172691|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
172692|NCT01473381|E4|Reported Event|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
172693|NCT01473381|E3|Reported Event|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
172694|NCT01473381|E2|Reported Event|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
172695|NCT01473381|E1|Reported Event|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
172696|NCT01473368|B5|Baseline|Total|Total of all reporting groups
172697|NCT01473368|B4|Baseline|Control|control group
172698|NCT01473368|B3|Baseline|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
172699|NCT01473368|B2|Baseline|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
172700|NCT01473368|B1|Baseline|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
172701|NCT01473368|P4|Participant Flow|Control|Control group
172702|NCT01473368|P3|Participant Flow|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
172703|NCT01473368|P2|Participant Flow|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
172704|NCT01473368|P1|Participant Flow|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
172705|NCT01473368|O7|Outcome|Prebiotic (Saccharomyces Boulardii) After Treatment|"After Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
172706|NCT01473368|O6|Outcome|Prebiotic (Saccharomyces Boulardii) During Treatment|"During Treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
172707|NCT01473368|O5|Outcome|Core Microbiome|Core Microbiome
172708|NCT01473368|O4|Outcome|Antibiotic (Amoxicillin Clavulanate) After Treatment|"After Treatment
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
172709|NCT01473368|O3|Outcome|Antibiotic (Amoxicillin Clavulanate) During Treatment|"During Treatment
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
172710|NCT01473368|O2|Outcome|Combination (Prebiotic and Antibiotic) After Treatment|"After Treatment
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
172711|NCT01473368|O1|Outcome|Combination (Prebiotic and Antibiotic) During Treatment|"During Treatment
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
172712|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic) After Treatment|"After treatment
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
172713|NCT01473368|O2|Outcome|Combination (Prebiotic and Antibiotic) During Treatment|"During treatment
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
172714|NCT01473368|O1|Outcome|Combination (Prebiotic and Antibiotic) Before Treatment|"Before treatment
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
172715|NCT01473368|O3|Outcome|Antibiotic (Amoxicillin Clavulanate) After Treatment|"After treatment
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
172762|NCT01472939|B1|Baseline|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
172717|NCT01473368|O1|Outcome|Antibiotic (Amoxicillin Clavulanate) Before Treatment|"Before treatment
Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
172718|NCT01473368|O3|Outcome|Prebiotic (Saccharomyces Boulardii) After Treatment|"After treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
172719|NCT01473368|O2|Outcome|Prebiotic (Saccharomyces Boulardii) During Treatment|"During treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
172720|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii) Before Treatment|"Before treatment
Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
172721|NCT01473368|O4|Outcome|Control|Control group
172722|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
172723|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
172724|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
172725|NCT01473368|O4|Outcome|Control|Control group
172726|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
172727|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
172728|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
172729|NCT01473368|O4|Outcome|Control|Control group
172730|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
172731|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
172732|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
172733|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
172734|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
172735|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
172736|NCT01473368|E4|Reported Event|Control|
172737|NCT01473368|E3|Reported Event|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
172738|NCT01473368|E2|Reported Event|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
172739|NCT01473368|E1|Reported Event|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
172740|NCT01473160|B1|Baseline|Overall Study|All enrolled participants
172741|NCT01473160|P1|Participant Flow|Overall Study|All enrolled participants
172742|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
172743|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
172744|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
172745|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
172746|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
172747|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
172748|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
172749|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
172750|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
172751|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
172752|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
172753|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
172754|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
172755|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
172756|NCT01473160|E2|Reported Event|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
172757|NCT01473160|E1|Reported Event|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
172758|NCT01472939|B5|Baseline|Total|Total of all reporting groups
172759|NCT01472939|B4|Baseline|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
172760|NCT01472939|B3|Baseline|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
172761|NCT01472939|B2|Baseline|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
172777|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
172778|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
172779|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
172780|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
172781|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
172782|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
172783|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
172784|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
172785|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
172786|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
172787|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
172788|NCT01472939|E4|Reported Event|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
172789|NCT01472939|E3|Reported Event|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
172790|NCT01472939|E2|Reported Event|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
172791|NCT01472939|E1|Reported Event|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
172792|NCT01472874|B1|Baseline|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172793|NCT01472874|P1|Participant Flow|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172794|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172795|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172796|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172797|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172798|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172799|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172800|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172801|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172802|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172803|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172804|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172805|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172806|NCT01472874|E1|Reported Event|Once a Day Trientine|"Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
172807|NCT01472835|B3|Baseline|Total|Total of all reporting groups
172808|NCT01472835|B2|Baseline|Control|Patient will not receive no sedation during their 1st procedure and sedation during their 2nd procedure
172977|NCT01471691|O2|Outcome|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
172905|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172809|NCT01472835|B1|Baseline|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid"
172810|NCT01472835|P2|Participant Flow|Control|Patient will not receive sedation during their 1st procedure, but receive sedation during the 2nd procedure
172811|NCT01472835|P1|Participant Flow|Sedation|"Pt will receive sedation with their 1st procedure, then a control procedure will be done without sedation
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid"
172812|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
172813|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid"
172814|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
172815|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid"
172816|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during the 1st procedure, but receive sedation during their 2nd procedure
172817|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid"
172818|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
172819|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid"
172820|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during their 1st procedure but receive sedation during their 2nd procedure
172821|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid"
172822|NCT01472835|E2|Reported Event|Control|Patient did not receive sedation during procedure
172823|NCT01472835|E1|Reported Event|Sedation|"Pt received sedation with their procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid"
172824|NCT01472822|B3|Baseline|Total|Total of all reporting groups
172825|NCT01472822|B2|Baseline|Placebo|
172826|NCT01472822|B1|Baseline|Omija|
172827|NCT01472822|P2|Participant Flow|Placebo|"Placebo(2times/day, 4tablets/day, 1.2g/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Omija extract.."
172828|NCT01472822|P1|Participant Flow|Omija Extract.|"Omija extract.(2times/day, 4tablets/day, 1.2g/day) for 12weeks
Omija extract.: Omija extracted with ethanol and then concentrated and dried."
172829|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
172830|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
172831|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
172832|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
172833|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
172834|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
172835|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
172836|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
172837|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
172838|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
172839|NCT01472822|E2|Reported Event|Placebo|
172840|NCT01472822|E1|Reported Event|Omija|
172841|NCT01472562|B1|Baseline|All Patients|Study Treatment Arm
172842|NCT01472562|P1|Participant Flow|All Patients|Study Treatment Arm
172843|NCT01472562|O1|Outcome|All Patients|Study Treatment Arm
172844|NCT01472562|O1|Outcome|All Patients|Study Treatment Arm
172845|NCT01472562|E1|Reported Event|All Patients|Study Treatment Arm
172846|NCT01472432|B3|Baseline|Total|Total of all reporting groups
172847|NCT01472432|B2|Baseline|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months
vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
172882|NCT01472289|B1|Baseline|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
172928|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172848|NCT01472432|B1|Baseline|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.
placebo: Placebo is added to the standard good medical practice."
172849|NCT01472432|P2|Participant Flow|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months
vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
172850|NCT01472432|P1|Participant Flow|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.
placebo: Placebo is added to the standard good medical practice."
172851|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months
vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
172852|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.
placebo: Placebo is added to the standard good medical practice."
172853|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months
vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea"
172854|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.
Placebo: Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea"
172855|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months
vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
172856|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.
placebo: Placebo is added to the standard good medical practice."
172857|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months
vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
172858|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.
placebo: Placebo is added to the standard good medical practice."
172859|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months
vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
172860|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.
placebo: Placebo is added to the standard good medical practice."
172861|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months
vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
172862|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.
placebo: Placebo is added to the standard good medical practice."
172863|NCT01472432|E2|Reported Event|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months
vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
172864|NCT01472432|E1|Reported Event|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.
placebo: Placebo is added to the standard good medical practice."
172865|NCT01472380|B1|Baseline|Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours
172866|NCT01472380|P1|Participant Flow|Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours
172867|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
172868|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
172869|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
172870|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
172871|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
172872|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
172873|NCT01472380|E3|Reported Event|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
172874|NCT01472380|E2|Reported Event|Fenofibric Acid Alone|On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
172875|NCT01472380|E1|Reported Event|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
172876|NCT01472341|B1|Baseline|All Participants|Participants receiving routine care under a diabetologist.
172877|NCT01472341|P1|Participant Flow|All Participants|Participants receiving routine care under a diabetologist.
172878|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
172879|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
172880|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
172881|NCT01472341|E1|Reported Event|All Participants|Participants receiving routine care under a diabetologist.
172978|NCT01471691|O1|Outcome|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
172979|NCT01471691|E2|Reported Event|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
172883|NCT01472289|P1|Participant Flow|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells (BMMNCs) concentrate prepared using the Res-Q 60 technology (a point of care system) and injected the concentrate intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
172884|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
172885|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
172886|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
172887|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
172888|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
172889|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
172890|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
172891|NCT01472289|E1|Reported Event|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
172892|NCT01472185|B3|Baseline|Total|Total of all reporting groups
172893|NCT01472185|B2|Baseline|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172894|NCT01472185|B1|Baseline|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172895|NCT01472185|P2|Participant Flow|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172896|NCT01472185|P1|Participant Flow|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172897|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172898|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172899|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172900|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172901|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172902|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172903|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172904|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172906|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172907|NCT01472185|E2|Reported Event|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172908|NCT01472185|E1|Reported Event|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.
Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.
Participants were required to maintain their diet and exercise regimen."
172909|NCT01471782|B7|Baseline|Total|Total of all reporting groups
172910|NCT01471782|B6|Baseline|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172911|NCT01471782|B5|Baseline|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172912|NCT01471782|B4|Baseline|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
172913|NCT01471782|B3|Baseline|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172914|NCT01471782|B2|Baseline|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172915|NCT01471782|B1|Baseline|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172916|NCT01471782|P6|Participant Flow|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172917|NCT01471782|P5|Participant Flow|Phase 1: Blinatumomab 5/15 µg/m²/Day|PK Expansion: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172918|NCT01471782|P4|Participant Flow|Phase 1: Blinatumomab 15/30 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
172919|NCT01471782|P3|Participant Flow|Phase 1: Blinatumomab 30 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172920|NCT01471782|P2|Participant Flow|Phase 1: Blinatumomab 15 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172921|NCT01471782|P1|Participant Flow|Phase 1: Blinatumomab 5 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172922|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day.
172923|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day.
172924|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day..
172925|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172926|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172927|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
172929|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172930|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172931|NCT01471782|O7|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172932|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172933|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172934|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
172935|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172936|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172937|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172938|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172939|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172940|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172941|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172942|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172943|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172944|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172945|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172946|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172947|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day.
172948|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day.
172949|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day.
172950|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172976|NCT01471691|P1|Participant Flow|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose Patients were given six months of monthly treatment with the standard 0.5mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
196298|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
172980|NCT01471691|E1|Reported Event|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
173207|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
172951|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
172952|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172953|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172954|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172955|NCT01471782|O7|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172956|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172957|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172958|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
172959|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172960|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172961|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172962|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
172963|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172964|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172965|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172966|NCT01471782|E6|Reported Event|Total|All Participants who received blinatumomab administered as a continuous intravenous infusion at a constant daily flow rate.
172967|NCT01471782|E5|Reported Event|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172968|NCT01471782|E4|Reported Event|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
172969|NCT01471782|E3|Reported Event|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
172970|NCT01471782|E2|Reported Event|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172971|NCT01471782|E1|Reported Event|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
172972|NCT01471691|B3|Baseline|Total|Total of all reporting groups
172973|NCT01471691|B2|Baseline|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
172974|NCT01471691|B1|Baseline|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
172975|NCT01471691|P2|Participant Flow|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose Patients were given six months of monthly treatment with the 1.0mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
172981|NCT01471626|B1|Baseline|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.
The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
172982|NCT01471626|P1|Participant Flow|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.
The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
172983|NCT01471626|O1|Outcome|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.
The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
172984|NCT01471626|E1|Reported Event|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.
The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
172985|NCT01471574|B5|Baseline|Total|Total of all reporting groups
172986|NCT01471574|B4|Baseline|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172987|NCT01471574|B3|Baseline|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172988|NCT01471574|B2|Baseline|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172989|NCT01471574|B1|Baseline|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172990|NCT01471574|P4|Participant Flow|Non-­HAART Therapy|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172991|NCT01471574|P3|Participant Flow|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172992|NCT01471574|P2|Participant Flow|HAART: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172993|NCT01471574|P1|Participant Flow|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172994|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173146|NCT01470469|E1|Reported Event|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
172995|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172996|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172997|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172998|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
172999|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173000|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30, 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173001|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173002|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173003|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173004|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173005|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg),, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173006|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173007|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173008|NCT01471574|O2|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173009|NCT01471574|O1|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173010|NCT01471574|O2|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173011|NCT01471574|O1|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173012|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173013|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173014|NCT01471574|O3|Outcome|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received daclatasvir tablets, 90 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173015|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173016|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173017|NCT01471574|E4|Reported Event|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173018|NCT01471574|E3|Reported Event|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173019|NCT01471574|E2|Reported Event|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173020|NCT01471574|E1|Reported Event|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
173021|NCT01471379|B4|Baseline|Total|Total of all reporting groups
173145|NCT01470469|E2|Reported Event|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
173022|NCT01471379|B3|Baseline|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
173023|NCT01471379|B2|Baseline|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.
Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
173024|NCT01471379|B1|Baseline|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
173025|NCT01471379|P3|Participant Flow|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
173026|NCT01471379|P2|Participant Flow|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.
Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
173027|NCT01471379|P1|Participant Flow|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg twice a day (BID) (n=20) during Phase I and will be increased to 100mg BID during Phase II
Milnacipran : 50mg Milnacipran per orally (PO), BID, for 6 weeks.
Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
173028|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
173029|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.
Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
173030|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
173031|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
173032|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.
Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
173033|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
173034|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
173035|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.
Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
173036|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
173037|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
173038|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.
Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
173039|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
173040|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
173041|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.
Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
173042|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A begins treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
173043|NCT01471379|E3|Reported Event|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
173044|NCT01471379|E2|Reported Event|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.
Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
173045|NCT01471379|E1|Reported Event|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II
Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.
Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
173046|NCT01471353|B1|Baseline|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
173074|NCT01471171|E2|Reported Event|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
196299|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
173047|NCT01471353|P1|Participant Flow|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
173048|NCT01471353|O1|Outcome|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
173049|NCT01471353|O1|Outcome|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
173050|NCT01471353|O1|Outcome|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
173051|NCT01471353|E1|Reported Event|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
173052|NCT01471197|B3|Baseline|Total|Total of all reporting groups
173053|NCT01471197|B2|Baseline|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
173054|NCT01471197|B1|Baseline|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
173055|NCT01471197|P2|Participant Flow|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 milligram per meter squared (mg/m^2), Once every 3 weeks during Treatment Phase, 10 minute infusion.
173056|NCT01471197|P1|Participant Flow|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
173057|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
173058|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
173059|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
173060|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
173061|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
173062|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
173063|NCT01471197|E2|Reported Event|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
173064|NCT01471197|E1|Reported Event|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
173065|NCT01471171|B1|Baseline|Overall Study Safety Population|All patients randomized into the crossover study were included in the safety population
173066|NCT01471171|P2|Participant Flow|Placebo - Aclidinium Bromide 400 μg|The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
173067|NCT01471171|P1|Participant Flow|Aclidinium Bromide 400 μg - Placebo|The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
173068|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
173069|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
173070|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
173071|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
173072|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
173073|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
173075|NCT01471171|E1|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
173076|NCT01471041|B1|Baseline|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
173077|NCT01471041|P1|Participant Flow|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
173078|NCT01471041|O1|Outcome|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
173079|NCT01471041|O1|Outcome|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
173080|NCT01471041|E1|Reported Event|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
173081|NCT01471015|B4|Baseline|Total|Total of all reporting groups
173082|NCT01471015|B3|Baseline|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old
Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
173083|NCT01471015|B2|Baseline|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.
Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
173084|NCT01471015|B1|Baseline|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days
Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
173085|NCT01471015|P3|Participant Flow|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old
Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
173086|NCT01471015|P2|Participant Flow|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.
Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
173087|NCT01471015|P1|Participant Flow|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days
Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
173088|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.
Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
173089|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days
Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
173090|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.
Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
173091|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days
Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
173092|NCT01471015|O3|Outcome|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old
Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
173093|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.
Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
173094|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days
Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
173095|NCT01471015|E3|Reported Event|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old
Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
173096|NCT01471015|E2|Reported Event|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.
Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
173097|NCT01471015|E1|Reported Event|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days
Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
173098|NCT01470859|B3|Baseline|Total|Total of all reporting groups
173099|NCT01470859|B2|Baseline|Levodopa|"Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
173100|NCT01470859|B1|Baseline|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
173144|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
196300|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
173101|NCT01470859|P2|Participant Flow|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
173102|NCT01470859|P1|Participant Flow|Levodopa|"Sinemet Controlled Release (CR)
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
173103|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
173104|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
173105|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
173106|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
173107|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
173108|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
173109|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
173110|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
173111|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
173112|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
173113|NCT01470859|E2|Reported Event|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
173114|NCT01470859|E1|Reported Event|Levodopa|"Sinemet CR
Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
173115|NCT01470651|B3|Baseline|Total|Total of all reporting groups
173116|NCT01470651|B2|Baseline|Sugar Pill|"Inactive pill, matched to look like active medication
Placebo Comparator: Inactive pill, matched to look like active medication"
173117|NCT01470651|B1|Baseline|Armodafinil|"Active medication
Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
173118|NCT01470651|P2|Participant Flow|Sugar Pill|"Inactive pill, matched to look like active medication
Placebo Comparator: Inactive pill, matched to look like active medication"
173119|NCT01470651|P1|Participant Flow|Armodafinil|"Active medication
Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
173120|NCT01470651|O2|Outcome|Sugar Pill|"Inactive pill, matched to look like active medication
Placebo Comparator: Inactive pill, matched to look like active medication"
173121|NCT01470651|O1|Outcome|Armodafinil|"Active medication
Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
173122|NCT01470651|O2|Outcome|Sugar Pill|"Inactive pill, matched to look like active medication
Placebo Comparator: Inactive pill, matched to look like active medication"
173123|NCT01470651|O1|Outcome|Armodafinil|"Active medication
Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
173124|NCT01470651|E2|Reported Event|Sugar Pill|"Inactive pill, matched to look like active medication
Placebo Comparator: Inactive pill, matched to look like active medication"
173125|NCT01470651|E1|Reported Event|Armodafinil|"Active medication
Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
173126|NCT01470469|B3|Baseline|Total|Total of all reporting groups
173127|NCT01470469|B2|Baseline|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
173128|NCT01470469|B1|Baseline|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
173129|NCT01470469|P2|Participant Flow|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
173130|NCT01470469|P1|Participant Flow|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
173131|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
173132|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
173133|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
173134|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
173135|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
173136|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
173137|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
173138|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
173139|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
173140|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
173141|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
173142|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
173143|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
173148|NCT01470417|B2|Baseline|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
173149|NCT01470417|B1|Baseline|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
173150|NCT01470417|P2|Participant Flow|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
173151|NCT01470417|P1|Participant Flow|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
173152|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
173153|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
173154|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
173155|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
173156|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
173157|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
173208|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
173209|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
173158|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
173159|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
173160|NCT01470417|E2|Reported Event|Chemotherapy and ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
173161|NCT01470417|E1|Reported Event|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
173162|NCT01470248|B1|Baseline|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.
Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
173163|NCT01470248|P1|Participant Flow|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.
Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
173164|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.
Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
173165|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.
Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
173166|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.
Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
173167|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.
Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
173168|NCT01470248|E1|Reported Event|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.
Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
173206|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
173169|NCT01470196|B1|Baseline|Treatment Arm|"Carfilzomib, dexamethasone, rituximab
Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8
Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8
Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
173170|NCT01470196|P1|Participant Flow|Carfilzomib, Dexamethasone, and Rituximab|"Carfilzomib, dexamethasone, rituximab
Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8
Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8
Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
173171|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab
Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8
Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8
Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
173172|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab
Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8
Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8
Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
173173|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab
Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8
Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8
Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
173174|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab
Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8
Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8
Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
173175|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab
Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8
Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8
Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
173176|NCT01470196|E1|Reported Event|Treatment Arm|"Carfilzomib, dexamethasone, rituximab
Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8
Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8
Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
173177|NCT01470170|B6|Baseline|Total|Total of all reporting groups
173178|NCT01470170|B5|Baseline|Group 5/ Control|Propofol alone
173179|NCT01470170|B4|Baseline|Group 4|alfentanil 5ug/kg two minutes before propofol
173180|NCT01470170|B3|Baseline|Group 3|alfentanil 5ug/kg immediately before propofol
173181|NCT01470170|B2|Baseline|Group 2|alfentanil 2.5ug/kg two minutes before propofol
173182|NCT01470170|B1|Baseline|Group1|alfentanil 2.5ug/kg immediately before propofol
173183|NCT01470170|P5|Participant Flow|Group 5 Control|TCI propofol administration alone
173184|NCT01470170|P4|Participant Flow|Group 4|Alfentanil 5μg/kg two minutes before TCI propofol administration
173185|NCT01470170|P3|Participant Flow|Group 3|Alfentanil 2.5μg/kg two minutes before TCI propofol administration
173186|NCT01470170|P2|Participant Flow|Group2|Alfentanil 5μg/kg immediately before TCI propofol administration
173187|NCT01470170|P1|Participant Flow|Group1|Alfentanil 2.5μg/kg immediately before TCI propofol administration
173188|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
173189|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
173190|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
173191|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
173192|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
173193|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
173194|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
173195|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
173196|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
173197|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
173198|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
173199|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
173200|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
173201|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
173202|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
173203|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
173204|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
173205|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
173210|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
173211|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
173212|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
173213|NCT01470170|E5|Reported Event|Group 5 /Control|Propofol alone
173214|NCT01470170|E4|Reported Event|Group 4|alfentanil 5ug/kg two minutes before propofol
173215|NCT01470170|E3|Reported Event|Group 3|alfentanil 5ug/kg immediately before propofol
173216|NCT01470170|E2|Reported Event|Group 2|alfentanil 2.5ug/kg two minutes before propofol
173217|NCT01470170|E1|Reported Event|Group1|alfentanil 2.5ug/kg immediately before propofol
173218|NCT01470144|B1|Baseline|Treatment|All patients who received at least one dose of EFI
173219|NCT01470144|P1|Participant Flow|Treatment|All patients who received at least one dose of EFI
173220|NCT01470144|O1|Outcome|Treatment|All patients who received at least one dose of EFI
173221|NCT01470144|O1|Outcome|Treatment|All patients who received at least one dose of EFI
173222|NCT01470144|E1|Reported Event|Treatment|All patients who received at least one dose of EFI
173223|NCT01470118|B4|Baseline|Total|Total of all reporting groups
173224|NCT01470118|B3|Baseline|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
173225|NCT01470118|B2|Baseline|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173226|NCT01470118|B1|Baseline|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173227|NCT01470118|P3|Participant Flow|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
173228|NCT01470118|P2|Participant Flow|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173229|NCT01470118|P1|Participant Flow|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173230|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
173231|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173232|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173233|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
173234|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173235|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173236|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
173237|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173238|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173239|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
173240|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173241|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173242|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
173243|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173244|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173245|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
173246|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173247|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173248|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
173249|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173250|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173251|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
173252|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173253|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173254|NCT01470118|E3|Reported Event|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
173255|NCT01470118|E2|Reported Event|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173256|NCT01470118|E1|Reported Event|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
173257|NCT01470001|B3|Baseline|Total|Total of all reporting groups
196301|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
173258|NCT01470001|B2|Baseline|Placebo|"patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
173360|NCT01469182|B2|Baseline|Placebo|Matching placebo tablet, sublingual, once daily.
173259|NCT01470001|B1|Baseline|Solifenacin|"patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
173260|NCT01470001|P2|Participant Flow|Placebo|study subjects who received placebo daily
173261|NCT01470001|P1|Participant Flow|Treatment|study subjects who received solifenacin 5mg daily
173262|NCT01470001|O2|Outcome|Placebo|"patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
173263|NCT01470001|O1|Outcome|Solifenacin|"patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
173264|NCT01470001|O2|Outcome|Placebo|"patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
173265|NCT01470001|O1|Outcome|Solifenacin|"patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
173266|NCT01470001|O2|Outcome|Placebo|"patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
173267|NCT01470001|O1|Outcome|Solifenacin|"patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
173268|NCT01470001|E2|Reported Event|Placebo|"patients is this arm will receive placebo
solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
173269|NCT01470001|E1|Reported Event|Solifenacin|"patients in this arm will receive drug
solifenacin: patient will receive solifenacin 5mg daily or placebo daily"
173270|NCT01469819|B1|Baseline|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
173271|NCT01469819|P1|Participant Flow|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
173272|NCT01469819|O1|Outcome|SIBO (+)|Twenty-five patients were tested for SIBO before treatment with lubiprostone and 17 (68.0%) were SIBO (+) at baseline.
173273|NCT01469819|O2|Outcome|Non-Responders|Subgroup of patients who had <2 times increase in their weekly bowel movement
173274|NCT01469819|O1|Outcome|Responders|Subgroup of patients who clinically responded to lubiprostone defined as > 2 times increase in their weekly bowel movement compared to baseline.
173275|NCT01469819|O2|Outcome|Non-Responders|Subgroup of patients who had <2 times increase in their weekly bowel movement.
173276|NCT01469819|O1|Outcome|Responders|Subgroup of patients who clinically responded to lubiprostone defined as ≥ 2 times increase in their weekly bowel movement.
173277|NCT01469819|O1|Outcome|All Participants|Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients aster all inclusionary criteria were met.
173278|NCT01469819|O1|Outcome|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
173279|NCT01469819|E1|Reported Event|All Participants|Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
173280|NCT01469767|B1|Baseline|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
173281|NCT01469767|P1|Participant Flow|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
173282|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
173283|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
173284|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
173285|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
173286|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
173287|NCT01469767|E1|Reported Event|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
173288|NCT01469715|B1|Baseline|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM
GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
173306|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
173357|NCT01469234|E2|Reported Event|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
173358|NCT01469234|E1|Reported Event|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
173289|NCT01469715|P1|Participant Flow|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM
GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
173290|NCT01469715|O1|Outcome|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM
GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
173291|NCT01469715|E1|Reported Event|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM
GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
173292|NCT01469637|B3|Baseline|Total|Total of all reporting groups
173293|NCT01469637|B2|Baseline|Sulfamethoxazole + MMX Mesalazine/Mesalamine First|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
173294|NCT01469637|B1|Baseline|Sulfamethoxazole + MMX Placebo First|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
173295|NCT01469637|P2|Participant Flow|Sulfamethoxazole + MMX Mesalazine/Mesalamine First|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
173296|NCT01469637|P1|Participant Flow|Sulfamethoxazole + MMX Placebo First|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
173297|NCT01469637|O2|Outcome|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
173298|NCT01469637|O1|Outcome|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
173299|NCT01469637|O2|Outcome|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
173300|NCT01469637|O1|Outcome|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
173301|NCT01469637|E2|Reported Event|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
173302|NCT01469637|E1|Reported Event|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
173303|NCT01469546|B1|Baseline|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
173304|NCT01469546|P1|Participant Flow|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
173305|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
173418|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173307|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
173308|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
173309|NCT01469546|E1|Reported Event|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
173310|NCT01469364|B1|Baseline|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173311|NCT01469364|P1|Participant Flow|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173312|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173313|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173314|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173315|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173316|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173317|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173318|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173319|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173320|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173356|NCT01469234|E3|Reported Event|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
173321|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173322|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173323|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173324|NCT01469364|E1|Reported Event|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)
Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
173325|NCT01469234|B4|Baseline|Total|Total of all reporting groups
173326|NCT01469234|B3|Baseline|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
173327|NCT01469234|B2|Baseline|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
173328|NCT01469234|B1|Baseline|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
173329|NCT01469234|P3|Participant Flow|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
173330|NCT01469234|P2|Participant Flow|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
173331|NCT01469234|P1|Participant Flow|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
173332|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
173333|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
173334|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
173335|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
173336|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
173337|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
173338|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
173339|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
173340|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
173341|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
173342|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
173343|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
173344|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
173345|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
173346|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
173347|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
173348|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
173349|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
173350|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
173351|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
173352|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
173353|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
173354|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
173355|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
173361|NCT01469182|B1|Baseline|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
173362|NCT01469182|P2|Participant Flow|Placebo|Matching placebo tablet, sublingual, once daily.
173363|NCT01469182|P1|Participant Flow|SCH 39641 12 Amb a 1-U|12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an allergy immunotherapy tablet (AIT), sublingual, once daily.
173364|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
173365|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
173366|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
173367|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
173368|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
173369|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
173370|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
173371|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
173372|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
173373|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
173374|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
173375|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
173376|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
173377|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
173378|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
173379|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
173380|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
173381|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
173382|NCT01469182|E2|Reported Event|Placebo|Matching placebo tablet, sublingual, once daily.
173383|NCT01469182|E1|Reported Event|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
173384|NCT01469065|B6|Baseline|Total|Total of all reporting groups
173385|NCT01469065|B5|Baseline|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173386|NCT01469065|B4|Baseline|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173387|NCT01469065|B3|Baseline|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173388|NCT01469065|B2|Baseline|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173389|NCT01469065|B1|Baseline|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
173390|NCT01469065|P5|Participant Flow|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173391|NCT01469065|P4|Participant Flow|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173392|NCT01469065|P3|Participant Flow|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173393|NCT01469065|P2|Participant Flow|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173394|NCT01469065|P1|Participant Flow|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
173395|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173396|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173397|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173398|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173399|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
173400|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173401|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173402|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173403|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173404|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
173405|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173406|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173407|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173408|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173409|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
173410|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173411|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173412|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173413|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173414|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
173415|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173416|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173417|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
196302|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
173419|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
173420|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173421|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173422|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173423|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173424|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
173425|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173426|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173427|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173428|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173429|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173430|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173431|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173432|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173433|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173434|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173435|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173436|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173437|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173438|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173439|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173440|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173441|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173442|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173443|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173444|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173445|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173446|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173447|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173448|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173449|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173450|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173451|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173452|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173453|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173454|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173455|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173456|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173457|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173458|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173459|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173460|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173461|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173462|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173463|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173464|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173465|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173466|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173467|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173468|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173469|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173470|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173471|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173472|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173473|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173474|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173475|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173476|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173477|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
173478|NCT01469065|E5|Reported Event|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
173479|NCT01469065|E4|Reported Event|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
173480|NCT01469065|E3|Reported Event|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
173825|NCT01467960|P6|Participant Flow|Group C|30 Patients at Stage more than III, H&Y classification
173481|NCT01469065|E2|Reported Event|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
173482|NCT01469065|E1|Reported Event|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
173483|NCT01469052|B7|Baseline|Total|Total of all reporting groups
173484|NCT01469052|B6|Baseline|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173485|NCT01469052|B5|Baseline|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173486|NCT01469052|B4|Baseline|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173487|NCT01469052|B3|Baseline|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173488|NCT01469052|B2|Baseline|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173489|NCT01469052|B1|Baseline|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173490|NCT01469052|P6|Participant Flow|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173491|NCT01469052|P5|Participant Flow|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173492|NCT01469052|P4|Participant Flow|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173493|NCT01469052|P3|Participant Flow|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173494|NCT01469052|P2|Participant Flow|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173495|NCT01469052|P1|Participant Flow|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 milligram (mg) tablet orally once daily (QD) followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally twice daily (BID) in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173496|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
173497|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
173498|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
173499|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
173500|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
173501|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
173502|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
173503|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
173504|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
173505|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
173506|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173507|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173508|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173509|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173510|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173511|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173512|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173513|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173514|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173515|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173822|NCT01467960|B3|Baseline|Group III|Healthy Subjects aged more than 65
173516|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173517|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173518|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173519|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173520|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173521|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173522|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173523|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173524|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173525|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173526|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173527|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173528|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173529|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173530|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173531|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
173532|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173533|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173534|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173535|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
173536|NCT01469052|O1|Outcome|All Treated Participants|All participants of Cohorts 1 to 6 received oral doses of axitinib (AG-013736) (10 mg and 15 mg, QD; 2 mg, 5 mg, 10 mg, 20 mg and 30 mg, BID) tablet in fed or fasted state in cycles of 4 weeks, up to 8 cycles.
173537|NCT01469052|E1|Reported Event|All Treated Participants|All participants of Cohorts 1 to 6 received oral doses of axitinib (AG-013736) (10 mg and 15 mg, QD; 2 mg, 5 mg, 10 mg, 20 mg and 30 mg, BID) tablet in fed or fasted state in cycles of 4 weeks, up to 8 cycles.
173538|NCT01469039|B4|Baseline|Total|Total of all reporting groups
173539|NCT01469039|B3|Baseline|Placebo|Intramuscular injection, given monthly
173540|NCT01469039|B2|Baseline|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
173541|NCT01469039|B1|Baseline|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
173542|NCT01469039|P3|Participant Flow|Placebo|Intramuscular injection, given monthly
173543|NCT01469039|P2|Participant Flow|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
173544|NCT01469039|P1|Participant Flow|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
173545|NCT01469039|O3|Outcome|Placebo|Intramuscular injection, given monthly
173546|NCT01469039|O2|Outcome|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
173547|NCT01469039|O1|Outcome|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
173548|NCT01469039|O3|Outcome|Placebo|Intramuscular injection, given monthly
173549|NCT01469039|O2|Outcome|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
173550|NCT01469039|O1|Outcome|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
173551|NCT01469039|E3|Reported Event|Placebo|Intramuscular injection, given monthly
173552|NCT01469039|E2|Reported Event|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
173553|NCT01469039|E1|Reported Event|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
173554|NCT01469000|B3|Baseline|Total|Total of all reporting groups
173555|NCT01469000|B2|Baseline|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
173556|NCT01469000|B1|Baseline|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
173557|NCT01469000|P2|Participant Flow|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
173614|NCT01468558|O2|Outcome|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
173826|NCT01467960|P5|Participant Flow|Group B|30 Patients at Stage II, H&Y classification
173558|NCT01469000|P1|Participant Flow|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
173559|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
173560|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
173561|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
173562|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
173563|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
173564|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
173565|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
173566|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
173567|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
173568|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
173569|NCT01469000|E2|Reported Event|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
173570|NCT01469000|E1|Reported Event|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
173571|NCT01468896|B3|Baseline|Total|Total of all reporting groups
173572|NCT01468896|B2|Baseline|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
173573|NCT01468896|B1|Baseline|Arm 1 (Phase 1)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
173574|NCT01468896|P2|Participant Flow|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
173575|NCT01468896|P1|Participant Flow|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
173576|NCT01468896|O2|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
173577|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
173578|NCT01468896|O2|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
173579|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
173580|NCT01468896|O2|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
173581|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
173582|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
173583|NCT01468896|O2|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
173584|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
173585|NCT01468896|O1|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
173586|NCT01468896|O2|Outcome|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
173587|NCT01468896|O1|Outcome|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
173588|NCT01468896|E2|Reported Event|Arm II (Phase II)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
173615|NCT01468558|O1|Outcome|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
173589|NCT01468896|E1|Reported Event|Arm 1 (Phase I)|Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.
173590|NCT01468818|B1|Baseline|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
173591|NCT01468818|P1|Participant Flow|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
173592|NCT01468818|O1|Outcome|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
173593|NCT01468818|O1|Outcome|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
173594|NCT01468818|E1|Reported Event|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
173595|NCT01468675|B3|Baseline|Total|Total of all reporting groups
173596|NCT01468675|B2|Baseline|Control|Usual Care
173597|NCT01468675|B1|Baseline|Intervention|Risk Assessment and Prevention Recommendations provided to subjects
173598|NCT01468675|P2|Participant Flow|Control|Control - Usual Care
173599|NCT01468675|P1|Participant Flow|Intervention|Risk Assessment and Prevention Recommendations
173600|NCT01468675|O2|Outcome|Control|Usual care
173601|NCT01468675|O1|Outcome|Intervention|"Validated, web-based risk assessment is being used to assess personalized risk and generate a risk report
risk assessment survey; decision support for providers for prevention based on risk"
173602|NCT01468675|E2|Reported Event|Control|Control subjects completed a risk factors/perceptions assessment and received a 1 page Health Risk Assessment (HRA) AFTER their primary care visit. Coded data was not sent to the EHR.
173603|NCT01468675|E1|Reported Event|Intervention|Intervention subjects completed a risk factors/perceptions assessment and received a 1 page Health Risk Assessment (HRA) prior to a primary care visit. This coded data was sent to the EHR. After their primary care visit, subjects again reported risk perception.
173604|NCT01468584|B1|Baseline|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
173605|NCT01468584|P1|Participant Flow|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
173606|NCT01468584|O1|Outcome|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
173607|NCT01468584|E1|Reported Event|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
173608|NCT01468558|B1|Baseline|Overall Study|All subjects that were enrolled in the study.
173609|NCT01468558|P1|Participant Flow|Overall Study|Subjects first received MAP0004 1.0mg via oral inhalation followed by 48 hours of PK sampling, they then received Ketoconazole (400mg once a day for 4 days) followed by MAP0004 1.0mg and another 48 hours of PK sampling. After a 7-11 day washout, subjects returned to the clinic to receive 1.0mg IV DHE and 48 hours of PK sampling.
173610|NCT01468558|O3|Outcome|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
173611|NCT01468558|O2|Outcome|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
173612|NCT01468558|O1|Outcome|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
173613|NCT01468558|O3|Outcome|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
173616|NCT01468558|E3|Reported Event|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
173617|NCT01468558|E2|Reported Event|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
173618|NCT01468558|E1|Reported Event|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
173619|NCT01468350|B5|Baseline|Total|Total of all reporting groups
173620|NCT01468350|B4|Baseline|(PART B) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo
Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day"
173621|NCT01468350|B3|Baseline|(PART B) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg
Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day"
173622|NCT01468350|B2|Baseline|(PART A) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart
Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo"
173623|NCT01468350|B1|Baseline|(PART A) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart
Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg"
173624|NCT01468350|P4|Participant Flow|(PART B) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo
Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day"
173625|NCT01468350|P3|Participant Flow|(PART B) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg
Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day"
173626|NCT01468350|P2|Participant Flow|(PART A) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart
Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo"
173627|NCT01468350|P1|Participant Flow|(PART A) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart
Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg"
173628|NCT01468350|O4|Outcome|PART B: Dalfampridine-ER 10mg|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)
Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
173629|NCT01468350|O3|Outcome|PART B: Placebo|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)
Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
173630|NCT01468350|O2|Outcome|PART A: Dalfampridine-ER 10mg|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)
A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
173631|NCT01468350|O1|Outcome|PART A: Placebo|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)
A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
173632|NCT01468350|E4|Reported Event|PART B: Dalfampridine-ER 10mg|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)
Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
173633|NCT01468350|E3|Reported Event|PART B: Placebo|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)
Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
173634|NCT01468350|E2|Reported Event|PART A: Dalfampridine-ER 10mg|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)
A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
173635|NCT01468350|E1|Reported Event|PART A: Placebo|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)
A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
173636|NCT01468337|B1|Baseline|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173689|NCT01468207|P5|Participant Flow|Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive adalimumab 40 mg eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
173690|NCT01468207|P4|Participant Flow|Adalimumab Every Week (EW)/Placebo|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
173637|NCT01468337|P1|Participant Flow|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173638|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173639|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173640|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173641|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173642|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173643|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173644|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173645|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173784|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173646|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173647|NCT01468337|E1|Reported Event|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.
All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
173648|NCT01468311|B1|Baseline|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
173649|NCT01468311|P1|Participant Flow|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
173650|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
173651|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
173652|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
173653|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
173654|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
173655|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
173656|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
173657|NCT01468311|E1|Reported Event|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
173658|NCT01468233|B3|Baseline|Total|Total of all reporting groups
173659|NCT01468233|B2|Baseline|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
173660|NCT01468233|B1|Baseline|Placebo|Placebo for 12 weeks
173661|NCT01468233|P6|Participant Flow|Adalimumab Every Week (EW)/Adalimumab Every Week (EW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
173662|NCT01468233|P5|Participant Flow|Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
173663|NCT01468233|P4|Participant Flow|Adalimumab Every Week (EW)/Placebo|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
173664|NCT01468233|P3|Participant Flow|Placebo/Placebo|Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).
173665|NCT01468233|P2|Participant Flow|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
173666|NCT01468233|P1|Participant Flow|Placebo|Placebo for 12 weeks
173667|NCT01468233|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
173668|NCT01468233|O1|Outcome|Placebo|Placebo for 12 weeks
173669|NCT01468233|O2|Outcome|Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3|Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
173670|NCT01468233|O1|Outcome|Placebo - Baseline NRS at Worst ≥ 3|Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
173671|NCT01468233|O2|Outcome|Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
173672|NCT01468233|O1|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks
173673|NCT01468233|O6|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
173674|NCT01468233|O5|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
173675|NCT01468233|O4|Outcome|Placebo - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.
173676|NCT01468233|O3|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks
173677|NCT01468233|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
173678|NCT01468233|O1|Outcome|Placebo|Placebo for 12 weeks
173679|NCT01468233|E6|Reported Event|Adalimumab EW/Adalimumab EW (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
173680|NCT01468233|E5|Reported Event|Adalimumab EW/Adalimumab EOW (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
173681|NCT01468233|E4|Reported Event|Adalimumab EW/Placebo (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
173682|NCT01468233|E3|Reported Event|Placebo/Placebo (Period 2)|Participants randomized to receive placebo in Period 1 received placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
173683|NCT01468233|E2|Reported Event|Adalimumab EW (Period 1)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
173684|NCT01468233|E1|Reported Event|Placebo (Period 1)|Placebo for 12 weeks.
173685|NCT01468207|B3|Baseline|Total|Total of all reporting groups
173686|NCT01468207|B2|Baseline|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
173687|NCT01468207|B1|Baseline|Placebo|Placebo for 12 weeks.
173688|NCT01468207|P6|Participant Flow|Adalimumab Every Week (EW)/Adalimumab Every Week (EW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
173818|NCT01467960|B7|Baseline|Total|Total of all reporting groups
173691|NCT01468207|P3|Participant Flow|Placebo/Adalimumab Every Week (EW)|Participants randomized to receive placebo in Period 1 received adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to Week 35 in Period 2 (up to 24 weeks).
173692|NCT01468207|P2|Participant Flow|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
173693|NCT01468207|P1|Participant Flow|Placebo|Placebo for 12 weeks.
173694|NCT01468207|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
173695|NCT01468207|O1|Outcome|Placebo|Placebo for 12 weeks.
173696|NCT01468207|O2|Outcome|Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3|Participants with baseline NRS ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
173697|NCT01468207|O1|Outcome|Placebo - Baseline NRS at Worst ≥ 3|Participants with baseline NRS ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
173698|NCT01468207|O2|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
173699|NCT01468207|O1|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
173700|NCT01468207|O6|Outcome|Adalimumab Every Week (ew) - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
173701|NCT01468207|O5|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
173702|NCT01468207|O4|Outcome|Placebo - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.
173703|NCT01468207|O3|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
173704|NCT01468207|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
173705|NCT01468207|O1|Outcome|Placebo|Placebo for 12 weeks.
173706|NCT01468207|E6|Reported Event|Adalimumab EW/Adalimumab EW (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
173707|NCT01468207|E5|Reported Event|Adalimumab EW/Adalimumab EOW (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive adalimumab 40 mg every other week (eow) from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
173708|NCT01468207|E4|Reported Event|Adalimumab EW/Placebo (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
173709|NCT01468207|E3|Reported Event|Placebo/Adalimumab EW (Period 2)|Participants randomized to receive placebo in Period 1 were re-randomized to receive adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg every week (ew) from Week 16 to Week 35 in Period 2 (up to 24 weeks).
173710|NCT01468207|E2|Reported Event|Adalimumab EW (Period 1)|Adalimumab every week (ew) for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
173711|NCT01468207|E1|Reported Event|Placebo (Period 1)|Placebo for 12 weeks
173712|NCT01468181|B6|Baseline|Total|Total of all reporting groups
173713|NCT01468181|B5|Baseline|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
173714|NCT01468181|B4|Baseline|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
173715|NCT01468181|B3|Baseline|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
173716|NCT01468181|B2|Baseline|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
173717|NCT01468181|B1|Baseline|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
173718|NCT01468181|P5|Participant Flow|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
173719|NCT01468181|P4|Participant Flow|LY2189265 + Thiazolidin Edione (TZD)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
173720|NCT01468181|P3|Participant Flow|LY2189265 + Alpha-glucosidas e Inhibitor (a-GI)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
173721|NCT01468181|P2|Participant Flow|LY2189265 + Biguanides (BG)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
173722|NCT01468181|P1|Participant Flow|LY2189265 + Sulfonylureas (SU)|"LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
173723|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
173724|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
173725|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
173726|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
173727|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
173728|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
173729|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
173730|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
173731|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
173732|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
173733|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
173734|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
173735|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
173736|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
173737|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
173738|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
173739|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
173740|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
173741|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
173742|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
173743|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
173744|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
173745|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
173746|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
173747|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
173748|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
173749|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
173750|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
173751|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
173752|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
173753|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
173754|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
173819|NCT01467960|B6|Baseline|Group C|Patients at stage > than II, H&Y
173755|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
173756|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
173757|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
173758|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
173759|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
173760|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
173761|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
173762|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
173763|NCT01468181|E5|Reported Event|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
173764|NCT01468181|E4|Reported Event|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
173765|NCT01468181|E3|Reported Event|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
173766|NCT01468181|E2|Reported Event|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
173767|NCT01468181|E1|Reported Event|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
173768|NCT01468077|B3|Baseline|Total|Total of all reporting groups
173769|NCT01468077|B2|Baseline|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173770|NCT01468077|B1|Baseline|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173771|NCT01468077|P2|Participant Flow|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173772|NCT01468077|P1|Participant Flow|Tocilizumab, Normal Administration|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173773|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173774|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173775|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173776|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173777|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173778|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173779|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173780|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173781|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173782|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173783|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173820|NCT01467960|B5|Baseline|Group B|Patients at Stage II, H&Y
173821|NCT01467960|B4|Baseline|Group A|Patients at Stage I, H&Y
173785|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173786|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173787|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173788|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173789|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173790|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173791|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173792|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173793|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173794|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173795|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173796|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173797|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173798|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173799|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173800|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173801|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173802|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173803|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173804|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173805|NCT01468077|E2|Reported Event|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
173806|NCT01468077|E1|Reported Event|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
173807|NCT01468012|B4|Baseline|Total|Total of all reporting groups
173808|NCT01468012|B3|Baseline|Non-randomized|
173809|NCT01468012|B2|Baseline|Placebo|"placebo
Placebo: matched placebo for LCE condition dosed twice daily"
173810|NCT01468012|B1|Baseline|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)
levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
173811|NCT01468012|P3|Participant Flow|Non-randomized|
173812|NCT01468012|P2|Participant Flow|Placebo|"placebo
Placebo: matched placebo for LCE condition dosed twice daily"
173813|NCT01468012|P1|Participant Flow|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)
levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
173814|NCT01468012|O2|Outcome|Placebo|"placebo
Placebo: matched placebo for LCE condition dosed twice daily"
173815|NCT01468012|O1|Outcome|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)
levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
173816|NCT01468012|E2|Reported Event|Placebo|"placebo
Placebo: matched placebo for LCE condition dosed twice daily"
173817|NCT01468012|E1|Reported Event|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)
levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
173827|NCT01467960|P4|Participant Flow|Group A|30 Patients at Stage I, H&Y classification
173828|NCT01467960|P3|Participant Flow|Group III|30 Healthy Subjects aged more than 65
173829|NCT01467960|P2|Participant Flow|Group II|30 Healthy Subjects aged 40-65
173830|NCT01467960|P1|Participant Flow|Group I|30 Healthy Subjects aged 20-40
173831|NCT01467960|O6|Outcome|Group C|Patients at stage > than II, H&Y
173832|NCT01467960|O5|Outcome|Group B|Patients at Stage II, H&Y
173833|NCT01467960|O4|Outcome|Group A|Patients at Stage I, H&Y
173834|NCT01467960|O3|Outcome|Group III|Healthy Subjects aged more than 65
173835|NCT01467960|O2|Outcome|Group II|Healthy Subjects aged 40-65
173836|NCT01467960|O1|Outcome|Group I|Healthy Subjects aged 20-40
173837|NCT01467960|E6|Reported Event|Group C|Patients at stage > than II, H&Y
173838|NCT01467960|E5|Reported Event|Group B|Patients at Stage II, H&Y
173839|NCT01467960|E4|Reported Event|Group A|Patients at Stage I, H&Y
173840|NCT01467960|E3|Reported Event|Group III|Healthy Subjects aged more than 65
173841|NCT01467960|E2|Reported Event|Group II|Healthy Subjects aged 40-65
173842|NCT01467960|E1|Reported Event|Group I|Healthy Subjects aged 20-40
173843|NCT01467947|B1|Baseline|C1 Esterase Inhibitor|Subjects received 20 IU/kg C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
173844|NCT01467947|P1|Participant Flow|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
173845|NCT01467947|O1|Outcome|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
173846|NCT01467947|O1|Outcome|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
173847|NCT01467947|E1|Reported Event|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
173848|NCT01467934|B4|Baseline|Total|Total of all reporting groups
173849|NCT01467934|B3|Baseline|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
173850|NCT01467934|B2|Baseline|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
173851|NCT01467934|B1|Baseline|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
173852|NCT01467934|P3|Participant Flow|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5ml IM x 1
173853|NCT01467934|P2|Participant Flow|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
173854|NCT01467934|P1|Participant Flow|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine 0.25ml IM X 1
173855|NCT01467934|O3|Outcome|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
173856|NCT01467934|O2|Outcome|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
173857|NCT01467934|O1|Outcome|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
173858|NCT01467934|E3|Reported Event|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
173859|NCT01467934|E2|Reported Event|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
173860|NCT01467934|E1|Reported Event|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
173861|NCT01467882|B1|Baseline|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173862|NCT01467882|P1|Participant Flow|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173863|NCT01467882|O1|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173864|NCT01467882|O1|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173865|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173866|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173867|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173868|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173869|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173870|NCT01467882|O1|Outcome|AOC Subset|All children in AOC subset who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173871|NCT01467882|O3|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173872|NCT01467882|O2|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173873|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173874|NCT01467882|O1|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
196303|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
173875|NCT01467882|O1|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173876|NCT01467882|O2|Outcome|All Children Follicle Stimulating Hormone|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173877|NCT01467882|O1|Outcome|All Children Luteinizing Hormone|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173878|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173879|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173880|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173881|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173882|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173883|NCT01467882|E1|Reported Event|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
173884|NCT01467713|B5|Baseline|Total|Total of all reporting groups
173885|NCT01467713|B4|Baseline|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173886|NCT01467713|B3|Baseline|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173887|NCT01467713|B2|Baseline|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173888|NCT01467713|B1|Baseline|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173889|NCT01467713|P4|Participant Flow|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173890|NCT01467713|P3|Participant Flow|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173891|NCT01467713|P2|Participant Flow|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173892|NCT01467713|P1|Participant Flow|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173893|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173894|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173895|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173896|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173897|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173898|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173899|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173900|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173901|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173902|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173903|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173904|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173905|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173906|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173907|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173908|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173909|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173910|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173911|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173912|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173913|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173914|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173915|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173916|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173917|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173918|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173919|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
196304|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
174867|NCT01465022|B1|Baseline|Combined Estrogen-progestin Pill|Study Arm A is one of two interventions (OCP).
173920|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173921|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173922|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173923|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173924|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173925|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173926|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173927|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173928|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173929|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173930|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173931|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173932|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173933|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173934|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173935|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173936|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173937|NCT01467713|E4|Reported Event|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173938|NCT01467713|E3|Reported Event|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173939|NCT01467713|E2|Reported Event|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
173940|NCT01467713|E1|Reported Event|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
173941|NCT01467700|B5|Baseline|Total|Total of all reporting groups
173942|NCT01467700|B4|Baseline|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173943|NCT01467700|B3|Baseline|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173944|NCT01467700|B2|Baseline|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
173945|NCT01467700|B1|Baseline|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173946|NCT01467700|P4|Participant Flow|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173947|NCT01467700|P3|Participant Flow|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173948|NCT01467700|P2|Participant Flow|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
173949|NCT01467700|P1|Participant Flow|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173950|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173951|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
173952|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
173953|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173954|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173955|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
173956|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
173957|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173958|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173959|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
173960|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
173961|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173962|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173963|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
173964|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
196305|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
173965|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173966|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173967|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
173968|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
173969|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173970|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173971|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
173972|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
173973|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173974|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173975|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
173976|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
173977|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173978|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173979|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
173980|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
173981|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173982|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173983|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
173984|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
173985|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173986|NCT01467700|E4|Reported Event|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173987|NCT01467700|E3|Reported Event|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
173988|NCT01467700|E2|Reported Event|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
173989|NCT01467700|E1|Reported Event|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
173990|NCT01467661|B1|Baseline|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
173991|NCT01467661|P1|Participant Flow|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
173992|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
173993|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
173994|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
173995|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
173996|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
173997|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
173998|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
174866|NCT01465022|B2|Baseline|Progestin-only Pill|Study Arm B is one of two interventions (POP).
173999|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
174000|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
174001|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
174002|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
174003|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
174004|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
174005|NCT01467661|E2|Reported Event|SPD422: Post-marketing Trial Safety Analysis Set|Included all subjects in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
174006|NCT01467661|E1|Reported Event|SPD422: Safety Analysis Set|Included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
174007|NCT01467583|B4|Baseline|Total|Total of all reporting groups
174008|NCT01467583|B3|Baseline|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis
Fondaparinux: 2.5 mg every 48 hours"
174009|NCT01467583|B2|Baseline|Renal Failure, on CRRT|Fondaparinux: 2.5 mg every 48 hours
174010|NCT01467583|B1|Baseline|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis
Fondaparinux: 2.5 mg every 48 hours"
174011|NCT01467583|P3|Participant Flow|Renal Failure, Not on Dialysis Fondaparinux: 2.5 mg q48 hr|"These are patients with acute kidney injury not yet on dialysis
Fondaparinux: 2.5 mg every 48 hours"
174012|NCT01467583|P2|Participant Flow|Renal Failure, on CRRT on Fondaparinux: 2.5 mg Every 48 Hours|These are renal failure patients, either acute or chronic on Fondaparinux: 2.5 mg every 48 hours
174013|NCT01467583|P1|Participant Flow|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis
Fondaparinux: 2.5 mg every 48 hours"
174014|NCT01467583|O3|Outcome|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis, receiving fondaparinux 2.5 mg subcutaneously every 48 hours
Fondaparinux: 2.5 mg every 48 hours"
174015|NCT01467583|O2|Outcome|Renal Failure-renal Replacement Therapy|"These are patients with renal failure, either acute or chronic, receiving fondaparinux 2.5 mg subcutaneously every 48 hours
Fondaparinux: 2.5 mg every 48 hours"
174016|NCT01467583|O1|Outcome|Renal Failure on Intermittent Dialysis (IHD)|"These are patients with renal failure, on IHD, receiving fondaparinux 2.5 mg subcutaneously every 48 hours
Fondaparinux: 2.5 mg every 48 hours"
174017|NCT01467583|O3|Outcome|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis
Fondaparinux: 2.5 mg every 48 hours"
174018|NCT01467583|O2|Outcome|Renal Failure-continuous Renal Replacement Therapy|These are renal failure patients, either acute or chronic, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
174019|NCT01467583|O1|Outcome|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis
Fondaparinux: 2.5 mg every 48 hours"
174020|NCT01467583|E3|Reported Event|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis
Fondaparinux: 2.5 mg every 48 hours"
174021|NCT01467583|E2|Reported Event|Renal Failure-continuous Renal Replacement Therapy|These are patients with renal failure, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
174022|NCT01467583|E1|Reported Event|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis
Fondaparinux: 2.5 mg every 48 hours"
174023|NCT01467570|B3|Baseline|Total|Total of all reporting groups
174024|NCT01467570|B2|Baseline|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174025|NCT01467570|B1|Baseline|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS : Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174026|NCT01467570|P2|Participant Flow|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174027|NCT01467570|P1|Participant Flow|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS : Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174028|NCT01467570|O2|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174029|NCT01467570|O1|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS : Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174030|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174031|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174032|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174033|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174034|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174035|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174036|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174037|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174038|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174039|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174040|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174041|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174042|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174043|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174044|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174045|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174046|NCT01467570|O2|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174047|NCT01467570|O1|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS : Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174048|NCT01467570|E2|Reported Event|ESPGHAN ORS|"ESPGHAN oral rehydration solution
ESPGHAN ORS: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174049|NCT01467570|E1|Reported Event|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:
fast oral rehydration in 3-4 hours by mouth
ORS given for ongoing losses until diarrhea stops (maintenance phase)"
174050|NCT01467557|B3|Baseline|Total|Total of all reporting groups
174051|NCT01467557|B2|Baseline|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users
etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses"
174052|NCT01467557|B1|Baseline|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users
narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses"
174053|NCT01467557|P2|Participant Flow|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users
etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses"
174054|NCT01467557|P1|Participant Flow|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users
narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses"
174055|NCT01467557|O2|Outcome|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users
etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.
Registered Wearers who had been recently fit with these daily disposable lenses."
174056|NCT01467557|O1|Outcome|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users
narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.
Registered Wearers who had been recently fit with these daily disposable lenses."
174057|NCT01467557|O2|Outcome|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users
etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.
Registered Wearers who had been recently fit with these daily disposable lenses."
174058|NCT01467557|O1|Outcome|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users
narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.
Registered Wearers who had been recently fit with these daily disposable lenses."
174059|NCT01467557|E2|Reported Event|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users
etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.
Registered Wearers who had been recently fit with these daily disposable lenses."
174060|NCT01467557|E1|Reported Event|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users
narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.
Registered Wearers who had been recently fit with these daily disposable lenses."
174061|NCT01467505|B3|Baseline|Total|Total of all reporting groups
174062|NCT01467505|B2|Baseline|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174063|NCT01467505|B1|Baseline|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174064|NCT01467505|P2|Participant Flow|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174065|NCT01467505|P1|Participant Flow|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174066|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174067|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174068|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174069|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174070|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174071|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174072|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174104|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
196306|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
174073|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174074|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174075|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174076|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174077|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174078|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174079|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174080|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174081|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174082|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174083|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174084|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174085|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174086|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174087|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174088|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174089|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174090|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174091|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174092|NCT01467505|E2|Reported Event|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174093|NCT01467505|E1|Reported Event|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
174094|NCT01467492|B3|Baseline|Total|Total of all reporting groups
174095|NCT01467492|B2|Baseline|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174096|NCT01467492|B1|Baseline|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174097|NCT01467492|P2|Participant Flow|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174098|NCT01467492|P1|Participant Flow|Group A - Black|Black/African American participants received telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing <75 kilograms [kg]) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174099|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174100|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174101|NCT01467492|O1|Outcome|All Participants|All enrolled participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174102|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174103|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
196585|NCT01387139|O1|Outcome|Ketamine Alone|
174105|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174106|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174107|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174108|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174109|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174110|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174111|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174112|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174113|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174114|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174115|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174116|NCT01467492|E2|Reported Event|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174117|NCT01467492|E1|Reported Event|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
174118|NCT01467479|B4|Baseline|Total|Total of all reporting groups
174119|NCT01467479|B3|Baseline|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174120|NCT01467479|B2|Baseline|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174121|NCT01467479|B1|Baseline|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174122|NCT01467479|P3|Participant Flow|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving raltegravir (RAL) based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174138|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174123|NCT01467479|P2|Participant Flow|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174124|NCT01467479|P1|Participant Flow|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving atazanavir/ritonavir (ATV/r) based HAART at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174125|NCT01467479|O1|Outcome|T/PR + HAART Regimen|Participants who were receiving either ATV/r based HAART or EFV based HAART or RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily or 1125 mg three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their respective HAART, as per standard practice and investigator discretion.
174126|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174127|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174128|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174129|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174130|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174131|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174132|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174133|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174134|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174135|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174136|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174137|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174168|NCT01467037|O1|Outcome|2 Versus 0 Doses|We compared Rotavirus VE between patients that received 2 versus 0 doses of RV1.
174139|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174140|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174141|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174142|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174143|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174144|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174145|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174146|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174147|NCT01467479|E3|Reported Event|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174148|NCT01467479|E2|Reported Event|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174149|NCT01467479|E1|Reported Event|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
174150|NCT01467076|B4|Baseline|Total|Total of all reporting groups
174151|NCT01467076|B3|Baseline|High Dose IPGE1|300 ng/kg/min
174152|NCT01467076|B2|Baseline|Low Dose IPGE1|150 ng/kg/min
174153|NCT01467076|B1|Baseline|Control|Aerosolized saline
174154|NCT01467076|P3|Participant Flow|High Dose IPGE1|300 ng/kg/min
174155|NCT01467076|P2|Participant Flow|Low Dose IPGE1|150 ng/kg/min
174156|NCT01467076|P1|Participant Flow|Control|Aerosolized saline
174157|NCT01467076|O3|Outcome|High Dose IPGE1|300 ng/kg/min
174158|NCT01467076|O2|Outcome|Low Dose IPGE1|150 ng/kg/min
174159|NCT01467076|O1|Outcome|Control|Aerosolized saline
174160|NCT01467076|E3|Reported Event|High Dose IPGE1|300 ng/kg/min
174161|NCT01467076|E2|Reported Event|Low Dose IPGE1|150 ng/kg/min
174162|NCT01467076|E1|Reported Event|Control|Aerosolized saline
174163|NCT01467037|B3|Baseline|Total|Total of all reporting groups
174164|NCT01467037|B2|Baseline|Rotavirus -Positive|All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus-positives were confirmed via real-time reverse-transcriptase polymerase chain reactions (RT-PCR). RT-PCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed.
174165|NCT01467037|B1|Baseline|Rotavirus-negative|All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group.
174166|NCT01467037|P1|Participant Flow|Vaccine Effectiveness Study Population|Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset
174167|NCT01467037|O2|Outcome|≥1 Versus 0 Dose|We compared Rotavirus VE between patients that received 1 versus 0 dose of RV1.
175512|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
174169|NCT01467037|O2|Outcome|Rotavirus-positive|All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus positives were confirmed via realtime reversetranscriptase polymerase chain reactions (RTPCR). RTPCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed.
174170|NCT01467037|O1|Outcome|Rotavirus-negative|All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group.
174171|NCT01467037|E1|Reported Event|Vaccine Effectiveness Study Population|Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset
174172|NCT01466881|B1|Baseline|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
174173|NCT01466881|P1|Participant Flow|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
174174|NCT01466881|O2|Outcome|Responders|Eligible Patients who received protocol treatment and achieved complete or partial response.
174175|NCT01466881|O1|Outcome|Non-responders|Eligible patients who received protocol treatment and did not respond to the protocol treatment. Patients for whom response assessment was inadequate were considered non-responders.
174176|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
174177|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
174178|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
174179|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
174180|NCT01466881|E1|Reported Event|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
174181|NCT01466790|B9|Baseline|Total|Total of all reporting groups
174182|NCT01466790|B8|Baseline|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174183|NCT01466790|B7|Baseline|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174184|NCT01466790|B6|Baseline|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174185|NCT01466790|B5|Baseline|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174186|NCT01466790|B4|Baseline|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174187|NCT01466790|B3|Baseline|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174188|NCT01466790|B2|Baseline|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174189|NCT01466790|B1|Baseline|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174190|NCT01466790|P8|Participant Flow|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174191|NCT01466790|P7|Participant Flow|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174192|NCT01466790|P6|Participant Flow|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174193|NCT01466790|P5|Participant Flow|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174194|NCT01466790|P4|Participant Flow|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174195|NCT01466790|P3|Participant Flow|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174196|NCT01466790|P2|Participant Flow|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174197|NCT01466790|P1|Participant Flow|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174198|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174199|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174200|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174201|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174202|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174203|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174204|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174205|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174206|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174207|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174208|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174209|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174210|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174211|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174212|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174213|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174214|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174375|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174215|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174216|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174217|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174218|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174219|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174220|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174221|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174222|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174223|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174224|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174225|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174226|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174227|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174228|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174229|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174230|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174231|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174232|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174233|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174234|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174327|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174235|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174236|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174237|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174238|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174239|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174240|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174241|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174242|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174243|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174244|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174245|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174246|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174247|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174248|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174249|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174250|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174251|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174252|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174253|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174254|NCT01466790|E4|Reported Event|Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
174374|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174376|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174255|NCT01466790|E3|Reported Event|Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
174256|NCT01466790|E2|Reported Event|Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
174257|NCT01466790|E1|Reported Event|Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
174258|NCT01466764|B3|Baseline|Total|Total of all reporting groups
174259|NCT01466764|B2|Baseline|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
174260|NCT01466764|B1|Baseline|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
174261|NCT01466764|P2|Participant Flow|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
174262|NCT01466764|P1|Participant Flow|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
174263|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
174264|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
174265|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
174266|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
174267|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
174268|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
174269|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
174270|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
174271|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
174272|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
174273|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
174274|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
174275|NCT01466764|O2|Outcome|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
174276|NCT01466764|O1|Outcome|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
174277|NCT01466764|E2|Reported Event|Saline Injection|"Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery."
196586|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
174278|NCT01466764|E1|Reported Event|Anakinra|"Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery."
174279|NCT01466673|B3|Baseline|Total|Total of all reporting groups
174280|NCT01466673|B2|Baseline|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174281|NCT01466673|B1|Baseline|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174282|NCT01466673|P2|Participant Flow|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174283|NCT01466673|P1|Participant Flow|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174284|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174285|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174286|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174287|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174288|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174289|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174290|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174291|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174292|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174293|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174294|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174295|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174296|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174297|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174298|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174299|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174300|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174301|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174302|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174303|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174304|NCT01466673|E2|Reported Event|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
174305|NCT01466673|E1|Reported Event|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
174306|NCT01466660|B3|Baseline|Total|Total of all reporting groups
174307|NCT01466660|B2|Baseline|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174308|NCT01466660|B1|Baseline|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174309|NCT01466660|P2|Participant Flow|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174310|NCT01466660|P1|Participant Flow|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40 milligram (mg), dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174311|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174312|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174313|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174314|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174315|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174316|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174317|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174318|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174319|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174320|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174321|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174322|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174323|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174324|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174325|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174326|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174556|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
174328|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174329|NCT01466660|O2|Outcome|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174330|NCT01466660|O1|Outcome|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174331|NCT01466660|E2|Reported Event|Gefitinib|Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
174332|NCT01466660|E1|Reported Event|Afatinib|Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
174333|NCT01466595|B3|Baseline|Total|Total of all reporting groups
174334|NCT01466595|B2|Baseline|Arm B: No Study Treatment|No study treatment for 4 weeks
174335|NCT01466595|B1|Baseline|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174336|NCT01466595|P2|Participant Flow|Arm B: No Study Treatment|No study treatment for 4 weeks
174337|NCT01466595|P1|Participant Flow|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174338|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174339|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174340|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174341|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174342|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174343|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174344|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174345|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174346|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174347|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174348|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174349|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174350|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174351|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174352|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174353|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174354|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174355|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174356|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174357|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174358|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174359|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174360|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174361|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174362|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174363|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174364|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174365|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174366|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174367|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174368|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174369|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174370|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174371|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174372|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174373|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
196587|NCT01387139|O1|Outcome|Ketamine Alone|
174377|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174378|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174379|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174380|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174381|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174382|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174383|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174384|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174385|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174386|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174387|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174388|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174389|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174390|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174391|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174392|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174393|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174394|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174395|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174396|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174397|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174398|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174399|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174400|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174401|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174402|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174403|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174404|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174405|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174406|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174407|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174408|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174409|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174410|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174411|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174412|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174413|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174414|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174415|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174416|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174417|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174418|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174419|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174420|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174421|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174422|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
174423|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174424|NCT01466595|E2|Reported Event|Arm B: No Study Treatment|No study treatment for 4 weeks
174425|NCT01466595|E1|Reported Event|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
174426|NCT01466491|B5|Baseline|Total|Total of all reporting groups
174557|NCT01466270|O2|Outcome|Arm II|"Patients receive placebo PO QD.
Placebo: Given PO"
174427|NCT01466491|B4|Baseline|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174428|NCT01466491|B3|Baseline|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174429|NCT01466491|B2|Baseline|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174430|NCT01466491|B1|Baseline|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174431|NCT01466491|P4|Participant Flow|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174432|NCT01466491|P3|Participant Flow|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174433|NCT01466491|P2|Participant Flow|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174434|NCT01466491|P1|Participant Flow|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174435|NCT01466491|O4|Outcome|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174558|NCT01466270|O1|Outcome|Arm I|"Patients receive donepezil hydrochloride PO QD.
donepezil hydrochloride: Given PO"
174436|NCT01466491|O3|Outcome|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174437|NCT01466491|O2|Outcome|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174438|NCT01466491|O1|Outcome|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174439|NCT01466491|O4|Outcome|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174440|NCT01466491|O3|Outcome|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174441|NCT01466491|O2|Outcome|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174442|NCT01466491|O1|Outcome|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174443|NCT01466491|E4|Reported Event|4-site PCB Followed by no Wait|"Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174444|NCT01466491|E3|Reported Event|4-Site PCB Followed by 3-minute Wait|"Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174559|NCT01466270|E2|Reported Event|Arm II - Placebo|Patients receive placebo PO QD.
174445|NCT01466491|E2|Reported Event|2-site Injection|"The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174446|NCT01466491|E1|Reported Event|4-site Injection|"The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period."
174447|NCT01466387|B7|Baseline|Total|Total of all reporting groups
174448|NCT01466387|B6|Baseline|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
174449|NCT01466387|B5|Baseline|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
174450|NCT01466387|B4|Baseline|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
174451|NCT01466387|B3|Baseline|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
174452|NCT01466387|B2|Baseline|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
174453|NCT01466387|B1|Baseline|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
174454|NCT01466387|P6|Participant Flow|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
174455|NCT01466387|P5|Participant Flow|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
174456|NCT01466387|P4|Participant Flow|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
174457|NCT01466387|P3|Participant Flow|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
174458|NCT01466387|P2|Participant Flow|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
174459|NCT01466387|P1|Participant Flow|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
174460|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
174461|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
174462|NCT01466387|O3|Outcome|Rabies|Subjects ≥18 years to ≤60 yars of age who received three doses of Rabies vaccine.
174463|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
174464|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
174465|NCT01466387|O3|Outcome|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
174466|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of rabies vaccine.
174467|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
174468|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
174469|NCT01466387|O1|Outcome|JE + Rab + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
174470|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
174471|NCT01466387|O1|Outcome|JE + Rab + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
174472|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
174473|NCT01466387|O1|Outcome|TF + YF + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
174474|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
174475|NCT01466387|O1|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
174476|NCT01466387|O2|Outcome|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
174477|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
174478|NCT01466387|O2|Outcome|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
174479|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
174480|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
174481|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
174482|NCT01466387|O2|Outcome|JE+Rab+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
174483|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
174484|NCT01466387|O2|Outcome|JE+Rab+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
174485|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
174486|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
174487|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
174488|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
174489|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
174490|NCT01466387|E6|Reported Event|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
174491|NCT01466387|E5|Reported Event|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
174492|NCT01466387|E4|Reported Event|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
174493|NCT01466387|E3|Reported Event|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
174494|NCT01466387|E2|Reported Event|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
174495|NCT01466387|E1|Reported Event|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
174496|NCT01466361|B5|Baseline|Total|Total of all reporting groups
174497|NCT01466361|B4|Baseline|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
174498|NCT01466361|B3|Baseline|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
174499|NCT01466361|B2|Baseline|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
174500|NCT01466361|B1|Baseline|Nicotine Lozenge 4 mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
174501|NCT01466361|P4|Participant Flow|Placebo Lozenge (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
174502|NCT01466361|P3|Participant Flow|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
174503|NCT01466361|P2|Participant Flow|Placebo Lozenge (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
174504|NCT01466361|P1|Participant Flow|Nicotine Lozenge 4 Milligrams (mg) (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
174505|NCT01466361|O4|Outcome|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
174506|NCT01466361|O3|Outcome|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
174507|NCT01466361|O2|Outcome|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
174508|NCT01466361|O1|Outcome|Nicotine Lozenge 4 mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
174509|NCT01466361|O2|Outcome|Heavy Smokers Group|Participants smoking more than 20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment
174510|NCT01466361|O1|Outcome|Light Smokers Group|Participants smoking between 6-20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment
174511|NCT01466361|O2|Outcome|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
174512|NCT01466361|O1|Outcome|Nicotine Lozenge 4mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
174513|NCT01466361|O2|Outcome|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route.
174560|NCT01466270|E1|Reported Event|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
174514|NCT01466361|O1|Outcome|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route.
174515|NCT01466361|E4|Reported Event|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
174516|NCT01466361|E3|Reported Event|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
174517|NCT01466361|E2|Reported Event|Nicotine Lozenge 4mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
174518|NCT01466361|E1|Reported Event|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
174519|NCT01466348|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures.
174520|NCT01466348|P2|Participant Flow|Paracetamol Powder Then Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of paracetamol soluble powder (1000 mg), then 200 mL solution of two soluble tablets [each tablet containing 500 mg paracetamol and 65 mg of caffeine]. A washout period of 5 hours was maintained.
174521|NCT01466348|P1|Participant Flow|Paracetamol/ Caffeine Tablet Then Paracetamol Powder|Participants were orally administered with 200 millilitre (mL) solution of two soluble tablets, [each tablet containing 500 milligram (mg) paracetamol and 65 mg of caffeine], then 200 mL solution of paracetamol soluble powder (1000 mg). A washout period of 5 hours was maintained.
174522|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174523|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
174524|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174525|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
174526|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174527|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine
174528|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174529|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
174530|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174531|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
174532|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174533|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
174534|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174535|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
174536|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174537|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
174538|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174539|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
174540|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174541|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine
174542|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174543|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
174544|NCT01466348|E2|Reported Event|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
174545|NCT01466348|E1|Reported Event|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
174546|NCT01466270|B3|Baseline|Total|Total of all reporting groups
174547|NCT01466270|B2|Baseline|Arm II - Placebo|Patients receive placebo PO QD.
174548|NCT01466270|B1|Baseline|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
174549|NCT01466270|P2|Participant Flow|Arm II - Placebo|Patients receive placebo PO QD.
174550|NCT01466270|P1|Participant Flow|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
174551|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
174552|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
174553|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
174554|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
174555|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
174561|NCT01466192|B1|Baseline|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
174562|NCT01466192|P1|Participant Flow|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
174563|NCT01466192|O1|Outcome|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
174564|NCT01466192|E1|Reported Event|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
174565|NCT01466179|B1|Baseline|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174566|NCT01466179|P1|Participant Flow|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174567|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174568|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174569|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174570|NCT01466179|O3|Outcome|Cycle 2: Blinatumomab 28 μg/Day|Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 2.
174571|NCT01466179|O2|Outcome|Cycle 1: Blinatumomab 28 μg/Day|Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
174572|NCT01466179|O1|Outcome|Cycle 1: Blinatumomab 9 μg/Day|Participants receiving 9 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
174573|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174574|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174575|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174576|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174577|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174578|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174579|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174580|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174581|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174582|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174583|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174584|NCT01466179|E1|Reported Event|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The the initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
174585|NCT01466153|B4|Baseline|TOTAL|Total of all reporting groups
175961|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
174586|NCT01466153|B3|Baseline|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174587|NCT01466153|B2|Baseline|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174588|NCT01466153|B1|Baseline|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174589|NCT01466153|P3|Participant Flow|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174590|NCT01466153|P2|Participant Flow|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174591|NCT01466153|P1|Participant Flow|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174592|NCT01466153|O2|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174593|NCT01466153|O1|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174594|NCT01466153|O2|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174595|NCT01466153|O1|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174596|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174597|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174598|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174599|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174600|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174601|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174602|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174603|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174604|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174645|NCT01466062|B1|Baseline|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174605|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174606|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174607|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174608|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174609|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174610|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174611|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174612|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174613|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174614|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174615|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174616|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174617|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174618|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174619|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174620|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174621|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174622|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174623|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174646|NCT01466062|P1|Participant Flow|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174624|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174625|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174626|NCT01466153|E3|Reported Event|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174627|NCT01466153|E2|Reported Event|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
174628|NCT01466153|E1|Reported Event|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
174629|NCT01466127|B3|Baseline|Total|Total of all reporting groups
174630|NCT01466127|B2|Baseline|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.
Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
174631|NCT01466127|B1|Baseline|Placebo|"Matched nasal spray placebo.
Placebo: Matched nasal spray placebo"
174632|NCT01466127|P2|Participant Flow|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.
Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
174633|NCT01466127|P1|Participant Flow|Placebo|"Matched nasal spray placebo.
Placebo: Matched nasal spray placebo"
174634|NCT01466127|O2|Outcome|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.
Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
174635|NCT01466127|O1|Outcome|Placebo|"Matched nasal spray placebo.
Placebo: Matched nasal spray placebo"
174636|NCT01466127|E2|Reported Event|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.
Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
174637|NCT01466127|E1|Reported Event|Placebo|"Matched nasal spray placebo.
Placebo: Matched nasal spray placebo"
174638|NCT01466075|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.
Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
174639|NCT01466075|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.
Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
174640|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.
Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
174641|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.
Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
174642|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.
Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
174643|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.
Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
174644|NCT01466075|E1|Reported Event|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.
Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
196588|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
174647|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174648|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174649|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174650|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174651|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174652|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174653|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174654|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174655|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174656|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174657|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174658|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174659|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174660|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174661|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174662|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174663|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174664|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174665|NCT01466062|E1|Reported Event|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
174666|NCT01465997|B3|Baseline|Total Title|
174667|NCT01465997|B2|Baseline|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
174668|NCT01465997|B1|Baseline|Lacosamide|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
174669|NCT01465997|P2|Participant Flow|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
174670|NCT01465997|P1|Participant Flow|Lacosamide|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
174671|NCT01465997|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
174672|NCT01465997|O1|Outcome|Lacosamide|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
174673|NCT01465997|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
174674|NCT01465997|O1|Outcome|Lacosamide|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
174784|NCT01465412|P1|Participant Flow|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174675|NCT01465997|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR) (SS)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
174676|NCT01465997|O1|Outcome|Lacosamide (SS)|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
174677|NCT01465997|E2|Reported Event|Carbamazepine-Controlled Release (CBZ-CR) (SS)|200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
174678|NCT01465997|E1|Reported Event|Lacosamide (SS)|50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
174679|NCT01465958|B1|Baseline|Safety Population|The safety population consisted of all subjects who received any amount of GAMUNEX-C. In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks. In the SC Phase, subjects received weekly subcutaneous infusion of Gamunex-C at a mg/kg dose based on intravenous dose of the subject and dosing interval x 1.37 conversion factor for 12 weeks.
174680|NCT01465958|P2|Participant Flow|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose of subject and dosing interval x 1.37 conversion factor for 12 weeks.
174681|NCT01465958|P1|Participant Flow|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
174682|NCT01465958|O2|Outcome|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
174683|NCT01465958|O1|Outcome|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: Two intravenous infusions at a dose of 200-600 mg/kg per intravenous infusion every 3-4 weeks for 4 to 5 weeks.
174684|NCT01465958|O2|Outcome|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
174685|NCT01465958|O1|Outcome|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: In the IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
174686|NCT01465958|E2|Reported Event|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
174687|NCT01465958|E1|Reported Event|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
174688|NCT01465802|B6|Baseline|Total|Total of all reporting groups
174689|NCT01465802|B5|Baseline|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
174690|NCT01465802|B4|Baseline|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174691|NCT01465802|B3|Baseline|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174692|NCT01465802|B2|Baseline|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174693|NCT01465802|B1|Baseline|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174694|NCT01465802|P5|Participant Flow|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
174785|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
174695|NCT01465802|P4|Participant Flow|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174696|NCT01465802|P3|Participant Flow|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05 percent (%) applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174697|NCT01465802|P2|Participant Flow|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174698|NCT01465802|P1|Participant Flow|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 milligram (mg) tablets orally (PO) taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174699|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
174700|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174701|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174702|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174703|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174704|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
174705|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174706|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174707|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174708|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174709|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174710|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174711|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
196589|NCT01387139|O1|Outcome|Ketamine Alone|
174712|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174713|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174714|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174715|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174716|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174717|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174718|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174719|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174720|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174721|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
174722|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
174723|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
174724|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
174725|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174726|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174727|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174728|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174744|NCT01465802|E2|Reported Event|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174786|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
174729|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174730|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174731|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174732|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174733|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174734|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174735|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174736|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174737|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174738|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174739|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174740|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174741|NCT01465802|E5|Reported Event|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
174742|NCT01465802|E4|Reported Event|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
174743|NCT01465802|E3|Reported Event|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
175962|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
174745|NCT01465802|E1|Reported Event|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
174746|NCT01465763|B4|Baseline|Total|Total of all reporting groups
174747|NCT01465763|B3|Baseline|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174748|NCT01465763|B2|Baseline|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174749|NCT01465763|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174750|NCT01465763|P3|Participant Flow|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174751|NCT01465763|P2|Participant Flow|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174752|NCT01465763|P1|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174753|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174754|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174755|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174756|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174757|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174758|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174759|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174760|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174761|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174762|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174763|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174764|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174765|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174766|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174767|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174768|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174769|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174770|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174771|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174772|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174773|NCT01465763|E3|Reported Event|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
174774|NCT01465763|E2|Reported Event|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174775|NCT01465763|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
174776|NCT01465412|B5|Baseline|Total|Total of all reporting groups
174777|NCT01465412|B4|Baseline|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
174778|NCT01465412|B3|Baseline|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
174779|NCT01465412|B2|Baseline|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174780|NCT01465412|B1|Baseline|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174781|NCT01465412|P4|Participant Flow|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
174782|NCT01465412|P3|Participant Flow|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
174783|NCT01465412|P2|Participant Flow|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174818|NCT01465412|E3|Reported Event|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
174787|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174788|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174789|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
174790|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
174791|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174792|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174793|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
174794|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
174795|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174796|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174797|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
174798|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
174799|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174800|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174801|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
174802|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
174803|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174804|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174805|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
174806|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
174807|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174808|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174809|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
174810|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
174811|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174812|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174813|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
174814|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
174815|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174816|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174817|NCT01465412|E4|Reported Event|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
174862|NCT01465048|E2|Reported Event|PfSPZ Challenge 2,500 IM|
174819|NCT01465412|E2|Reported Event|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174820|NCT01465412|E1|Reported Event|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
174821|NCT01465386|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
bortezomib: Given SC"
174822|NCT01465386|P1|Participant Flow|Treated Patients|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
bortezomib: Given SC"
174823|NCT01465386|O1|Outcome|Treated Patients|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
bortezomib: Given SC"
174824|NCT01465386|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
bortezomib: Given SC"
174825|NCT01465347|B1|Baseline|TSC 0.25 mg/kg for 9 or 18 Doses|Trans Sodium Crocetinate (TSC): TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
174826|NCT01465347|P2|Participant Flow|TSC 0.25 mg/kg - 18 Dose Group|Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
174827|NCT01465347|P1|Participant Flow|TSC 0.25 mg/kg - 9 Dose Group|Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
174828|NCT01465347|O2|Outcome|TSC 0.25 mg/kg - 18 Dose Group - Phase 2|Trans Sodium Crocetinate (TSC): TSC administered intravenously for 18 doses as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
174829|NCT01465347|O1|Outcome|TSC 0.25mg/kg - 9 Dose Group - Phase 1|Phase 1 was the safety lead-in portion of the study conducted to evaluate an initial TSC dosage regimen in a smaller number of subjects and for a shorter period before a larger number of subjects were studied for a longer period in phase 2. Three (3) subjects were dosed with TSC at 0.25mg/kg for 3 weeks for a total of 9 doses with monitoring for dose-limiting toxicity (DLT). A Safety Monitoring Committee (SMC) evaluated the safety data and recommended TSC 0.25mg/kg for phase 2.
174830|NCT01465347|O1|Outcome|TSC 0.25 mg/kg - 18 Dose Group - Phase 2|Trans Sodium Crocetinate (TSC): TSC administered intravenously for 18 doses as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
174831|NCT01465347|O1|Outcome|TSC 0.25 mg/kg - 18 Dose Group - Phase 2|Trans Sodium Crocetinate (TSC): TSC administered intravenously for 18 doses as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
174832|NCT01465347|O2|Outcome|TSC 0.25 mg/kg - 18 Dose Group|Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
174833|NCT01465347|O1|Outcome|TSC 0.25 mg/kg - 9 Dose Group|Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
174834|NCT01465347|E2|Reported Event|TSC 0.25 mg/kg - 18 Dose Group|Phase 2: 6 weeks of TSC (18 doses in total) with concomitant RT and temozolomide for 6 weeks
174835|NCT01465347|E1|Reported Event|TSC 0.25 mg/kg - 9 Dose Group|Phase 1: 3 weeks of TSC (9 doses in total) with concomitant RT and temozolomide for 6 weeks
174836|NCT01465230|B1|Baseline|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
174837|NCT01465230|P1|Participant Flow|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
174838|NCT01465230|O1|Outcome|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
174839|NCT01465230|E1|Reported Event|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
174840|NCT01465178|B3|Baseline|Total|Total of all reporting groups
174841|NCT01465178|B2|Baseline|Placebo|"Non-matching placebo, gelatin filled capsules
Placebo: matching placebo"
174842|NCT01465178|B1|Baseline|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules
cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
174843|NCT01465178|P2|Participant Flow|Placebo|"Non-matching placebo, gelatin filled capsules
Placebo: matching placebo"
174844|NCT01465178|P1|Participant Flow|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules
cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
174845|NCT01465178|O2|Outcome|Placebo|"Non-matching placebo, gelatin filled capsules
Placebo: matching placebo"
174846|NCT01465178|O1|Outcome|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules
cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
174847|NCT01465178|O2|Outcome|Placebo|"Non-matching placebo, gelatin filled capsules
Placebo: matching placebo"
174848|NCT01465178|O1|Outcome|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules
cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
174849|NCT01465178|E2|Reported Event|Placebo|"Non-matching placebo, gelatin filled capsules
Placebo: matching placebo"
174850|NCT01465178|E1|Reported Event|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules
cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
174851|NCT01465048|B4|Baseline|Total|Total of all reporting groups
174852|NCT01465048|B3|Baseline|PfSPZ Challenge 25,000 IM|
174853|NCT01465048|B2|Baseline|PfSPZ Challenge 2,500 IM|
174854|NCT01465048|B1|Baseline|PfSPZ Challenge 2,500 ID|
174855|NCT01465048|P3|Participant Flow|PfSPZ Challenge 25,000 IM|
174856|NCT01465048|P2|Participant Flow|PfSPZ Challenge 2,500 IM|
174857|NCT01465048|P1|Participant Flow|PfSPZ Challenge 2,500 ID|
174858|NCT01465048|O3|Outcome|PfSPZ Challenge 25,000 IM|
174859|NCT01465048|O2|Outcome|PfSPZ Challenge 2,500 IM|
174860|NCT01465048|O1|Outcome|PfSPZ Challenge 2,500 ID|
174861|NCT01465048|E3|Reported Event|PfSPZ Challenge 25,000 IM|
174868|NCT01465022|P3|Participant Flow|Not Randomized|Participants who were consented but not randomized.
174869|NCT01465022|P2|Participant Flow|Progestin-only Pill|Study Arm B is one of two interventions.
174870|NCT01465022|P1|Participant Flow|Combined Estrogen-progestin Pill|Study Arm A is one of two interventions.
174871|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)
Progestin-only pill: .35 mg norethindrone once a day orally"
174872|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
174873|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)
Progestin-only pill: .35 mg norethindrone once a day orally"
174874|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
174875|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)
Progestin-only pill: .35 mg norethindrone once a day orally"
174876|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
174877|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)
Progestin-only pill: .35 mg norethindrone once a day orally"
174878|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
174879|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)
Progestin-only pill: .35 mg norethindrone once a day orally"
174880|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
174881|NCT01465022|E2|Reported Event|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)
Progestin-only pill: .35 mg norethindrone once a day orally"
174882|NCT01465022|E1|Reported Event|Combined Estrogin-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
174883|NCT01464996|B1|Baseline|All Study Participants|Will include composite restorations placed using both dental adhesives OptiBond XTR and OptiBond FL.
174884|NCT01464996|P1|Participant Flow|All Study Participants|"Will include composite restorations placed using both the dental adhesive OptiBond XTR and OptiBond FL.
Participants were randomized to receive either type of intervention"
174885|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.
Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
174886|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.
Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
174887|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.
Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
174888|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.
Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
174889|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.
Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
174890|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.
Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
174891|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.
Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
174892|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.
Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
174893|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.
Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
174894|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.
Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
174895|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.
Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
174896|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.
Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
174897|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.
Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
174898|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.
Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
175162|NCT01464229|B2|Baseline|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks then iloperidone for 4 weeks; addition to standard SSRI antidepressant
175968|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
174899|NCT01464996|E2|Reported Event|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.
Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
174900|NCT01464996|E1|Reported Event|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.
Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
174901|NCT01464931|B3|Baseline|Total|Total of all reporting groups
174902|NCT01464931|B2|Baseline|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174903|NCT01464931|B1|Baseline|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174904|NCT01464931|P2|Participant Flow|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174905|NCT01464931|P1|Participant Flow|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174906|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174907|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174908|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174909|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174910|NCT01464931|O2|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
174911|NCT01464931|O1|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
174912|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
174913|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
174914|NCT01464931|O4|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
174915|NCT01464931|O3|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
174916|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
174917|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
174918|NCT01464931|O4|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
174919|NCT01464931|O3|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
174920|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
174921|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
174922|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174923|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174924|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174925|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174926|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174927|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174928|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174929|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174930|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174931|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174932|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174933|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174934|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174935|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174936|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174937|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174938|NCT01464931|E3|Reported Event|Denosumab 120 mg - All Subjects|Participants received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174939|NCT01464931|E2|Reported Event|Denosumab 120 mg - ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174940|NCT01464931|E1|Reported Event|Denosumab 120 mg - Severe|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
174941|NCT01464879|B1|Baseline|Testosterone Topical|Initially study subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, study subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between.
174942|NCT01464879|P1|Participant Flow|Testosterone Topical|Initially subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between.
174943|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174944|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174945|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174946|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174947|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174948|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174949|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
174950|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174951|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
174952|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
174953|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174954|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
174955|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
174956|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174957|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
174958|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
174959|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174960|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
174961|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
175963|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
174962|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174963|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
174964|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
174965|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174966|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
174967|NCT01464879|O1|Outcome|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174968|NCT01464879|O3|Outcome|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
174969|NCT01464879|O2|Outcome|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174970|NCT01464879|O1|Outcome|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
174971|NCT01464879|E4|Reported Event|Testosterone 3.75 mL (Applicator)|Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
174972|NCT01464879|E3|Reported Event|Testosterone 2.50 mL (Applicator)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174973|NCT01464879|E2|Reported Event|Testosterone 1.25 mL (Applicator)|Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
174974|NCT01464879|E1|Reported Event|Testosterone 2.50 mL (Hand)|Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
174975|NCT01464840|B4|Baseline|Total|Total of all reporting groups
174976|NCT01464840|B3|Baseline|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174977|NCT01464840|B2|Baseline|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174978|NCT01464840|B1|Baseline|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174979|NCT01464840|P3|Participant Flow|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174980|NCT01464840|P2|Participant Flow|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174981|NCT01464840|P1|Participant Flow|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174982|NCT01464840|O3|Outcome|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174983|NCT01464840|O2|Outcome|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174984|NCT01464840|O1|Outcome|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174985|NCT01464840|E3|Reported Event|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174986|NCT01464840|E2|Reported Event|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174987|NCT01464840|E1|Reported Event|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour"
174988|NCT01464827|B15|Baseline|Total|Total of all reporting groups
174989|NCT01464827|B14|Baseline|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
174990|NCT01464827|B13|Baseline|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
174991|NCT01464827|B12|Baseline|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
174992|NCT01464827|B11|Baseline|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175163|NCT01464229|B1|Baseline|Iloperidone, Then Placebo|Iloperidone: Iloperidone 1-8 mg for 4 weeks then placebo for 4 weeks, in addition to SSRI antidepressant
174993|NCT01464827|B10|Baseline|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
174994|NCT01464827|B9|Baseline|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
174995|NCT01464827|B8|Baseline|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
174996|NCT01464827|B7|Baseline|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
174997|NCT01464827|B6|Baseline|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
174998|NCT01464827|B5|Baseline|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
174999|NCT01464827|B4|Baseline|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175000|NCT01464827|B3|Baseline|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175001|NCT01464827|B2|Baseline|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175002|NCT01464827|B1|Baseline|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
175003|NCT01464827|P14|Participant Flow|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175004|NCT01464827|P13|Participant Flow|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175005|NCT01464827|P12|Participant Flow|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175006|NCT01464827|P11|Participant Flow|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175007|NCT01464827|P10|Participant Flow|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175008|NCT01464827|P9|Participant Flow|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175009|NCT01464827|P8|Participant Flow|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175010|NCT01464827|P7|Participant Flow|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175011|NCT01464827|P6|Participant Flow|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175012|NCT01464827|P5|Participant Flow|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
175013|NCT01464827|P4|Participant Flow|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175014|NCT01464827|P3|Participant Flow|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175015|NCT01464827|P2|Participant Flow|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175016|NCT01464827|P1|Participant Flow|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
175017|NCT01464827|O2|Outcome|Groups K + L + M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
175018|NCT01464827|O1|Outcome|Groups F + G + H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
175019|NCT01464827|O2|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175020|NCT01464827|O1|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily, for 12 weeks.
175021|NCT01464827|O3|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175964|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
175022|NCT01464827|O2|Outcome|Groups C + D + J|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175023|NCT01464827|O1|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175024|NCT01464827|O3|Outcome|Groups H + I + M + N|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175025|NCT01464827|O2|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175026|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
175027|NCT01464827|O14|Outcome|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175028|NCT01464827|O13|Outcome|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175029|NCT01464827|O12|Outcome|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175030|NCT01464827|O11|Outcome|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175031|NCT01464827|O10|Outcome|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175032|NCT01464827|O9|Outcome|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175033|NCT01464827|O8|Outcome|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175034|NCT01464827|O7|Outcome|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175035|NCT01464827|O6|Outcome|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175036|NCT01464827|O5|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
175037|NCT01464827|O4|Outcome|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175038|NCT01464827|O3|Outcome|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175039|NCT01464827|O2|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175040|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
175041|NCT01464827|O9|Outcome|Group M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175042|NCT01464827|O8|Outcome|Group K + L|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175043|NCT01464827|O7|Outcome|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175044|NCT01464827|O6|Outcome|Group H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175045|NCT01464827|O5|Outcome|Group F + G|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175046|NCT01464827|O4|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
175047|NCT01464827|O3|Outcome|Group C + D|Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175048|NCT01464827|O2|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175049|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
175050|NCT01464827|E9|Reported Event|Group M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175965|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
175051|NCT01464827|E8|Reported Event|Group K + L|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175052|NCT01464827|E7|Reported Event|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175053|NCT01464827|E6|Reported Event|Group H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
175054|NCT01464827|E5|Reported Event|Group F + G|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175055|NCT01464827|E4|Reported Event|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
175056|NCT01464827|E3|Reported Event|Group C + D|Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
175057|NCT01464827|E2|Reported Event|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
175058|NCT01464827|E1|Reported Event|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
175059|NCT01464788|B4|Baseline|Total|Total of all reporting groups
175060|NCT01464788|B3|Baseline|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175061|NCT01464788|B2|Baseline|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175062|NCT01464788|B1|Baseline|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175063|NCT01464788|P3|Participant Flow|Rt-PA (Alteplase) Only|Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour.
175064|NCT01464788|P2|Participant Flow|High Dose Argatroban + Rt-PA (Alteplase)|"Argatroban: 100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours.
and
Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour."
175065|NCT01464788|P1|Participant Flow|Low-dose Argatroban + Rt-PA (Alteplase)|"100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours.
and
Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour."
175066|NCT01464788|O3|Outcome|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175067|NCT01464788|O2|Outcome|High Dose Argatroban + Rt-PA (Alteplase)|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175068|NCT01464788|O1|Outcome|Low Dose Argatroban + Rt-PA (Alteplase)|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175069|NCT01464788|O3|Outcome|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175070|NCT01464788|O2|Outcome|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175071|NCT01464788|O1|Outcome|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175072|NCT01464788|E3|Reported Event|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175073|NCT01464788|E2|Reported Event|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175074|NCT01464788|E1|Reported Event|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
175075|NCT01464619|B3|Baseline|Total|Total of all reporting groups
175076|NCT01464619|B2|Baseline|Intervention|"Caregivers assigned to the intervention arm will be assigned to the Incredible Years parenting intervention immediately after enrollment. They will also receive enhanced mental health referrals and monthly follow-up phone calls.
The Incredible Years Parenting Intervention: The Incredible Years Parents, Babies, and Toddlers Program is a validated group parenting education program, which has been adapted for use with depressed caregivers by inclusion of psychoeducational depression materials."
175077|NCT01464619|B1|Baseline|Delayed Intervention|"Those assigned to the delayed intervention arm will receive enhanced mental health referrals, monthly follow-up phone calls, and will be assigned to the parenting intervention 3-4 months after enrollment.
Delayed Intervention: Caregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment."
175078|NCT01464619|P2|Participant Flow|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175079|NCT01464619|P1|Participant Flow|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175080|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175081|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175082|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175083|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175084|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175085|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175086|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175087|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175088|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
175089|NCT01464619|O1|Outcome|Intervention|Subjects received parenting intervention immediately
175090|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175091|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175092|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
175093|NCT01464619|O1|Outcome|Intervention|Subjects received parenting intervention immediately
175094|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175095|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
175096|NCT01464619|E2|Reported Event|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
175097|NCT01464619|E1|Reported Event|Intervention|Subjects received parenting intervention immediately
175098|NCT01464424|B1|Baseline|Overall|Travoprost 0.004% and bimatoprost 0.01% in cross-over fashion, as randomized, 6 weeks each
175099|NCT01464424|P2|Participant Flow|LUMIGAN, Then TRAVATAN|Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks
175100|NCT01464424|P1|Participant Flow|TRAVATAN, Then LUMIGAN|Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks
175101|NCT01464424|O2|Outcome|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
175102|NCT01464424|O1|Outcome|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
175103|NCT01464424|O2|Outcome|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
175104|NCT01464424|O1|Outcome|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
175105|NCT01464424|E2|Reported Event|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
175106|NCT01464424|E1|Reported Event|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
175107|NCT01464359|B1|Baseline|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175130|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
175164|NCT01464229|P2|Participant Flow|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks, then iloperidone for 4 weeks; in addition to standard SSRI antidepressant
175108|NCT01464359|P1|Participant Flow|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175109|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175110|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175111|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175112|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175113|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175114|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175115|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175160|NCT01464255|E1|Reported Event|Ocufilcon D|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
175116|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175117|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175118|NCT01464359|E1|Reported Event|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses
Alternate preparative therapy for patients not able to receive additional radiation
Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
175119|NCT01464307|B3|Baseline|Total|Total of all reporting groups
175120|NCT01464307|B2|Baseline|Main Period: Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
175121|NCT01464307|B1|Baseline|Main Period: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
175122|NCT01464307|P2|Participant Flow|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
175123|NCT01464307|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl), 400 units, total volume 8.0 milliliter (mL); Mode of administration: intramuscular injection.
IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection sessions of solution, prepared by reconstitution of powder with 0.9% NaCl, 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
175124|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
175125|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
175126|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
175127|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
175128|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
175129|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
175131|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
175132|NCT01464307|E3|Reported Event|Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
175133|NCT01464307|E2|Reported Event|Main Period: Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
175134|NCT01464307|E1|Reported Event|Main Period: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
175135|NCT01464255|B3|Baseline|Total|Total of all reporting groups
175136|NCT01464255|B2|Baseline|Ocufilcon B Then Ocufilcon D|Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
175137|NCT01464255|B1|Baseline|Ocufilcon D Then Ocufilcon B|Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
175138|NCT01464255|P2|Participant Flow|Ocufulcon B Then Ocufilcon D|Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
175139|NCT01464255|P1|Participant Flow|Ocufilcon D Then Ocufilcon B|Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
175140|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175141|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175142|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175143|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175144|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
175145|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
175146|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
175147|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
175148|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
175149|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
175150|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
175151|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175152|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175153|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175154|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175155|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175156|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175157|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175158|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
175159|NCT01464255|E2|Reported Event|Ocufilcon B|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
175165|NCT01464229|P1|Participant Flow|Iloperidone, Then Placebo|Iloperidone (1-8 mg) for 4 weeks, then placebo for 4 weeks; in addition to standard SSRI antidepressant
175166|NCT01464229|O2|Outcome|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks then iloperidone for 4 weeks; addition to standard SSRI antidepressant
175167|NCT01464229|O1|Outcome|Iloperidone, Then Placebo|Iloperidone: Iloperidone 1-8 mg for 4 weeks then placebo for 4 weeks; addition to SSRI antidepressant
175168|NCT01464229|E2|Reported Event|Placebo|
175169|NCT01464229|E1|Reported Event|Iloperidone|
175170|NCT01464190|B3|Baseline|Total|Total of all reporting groups
175171|NCT01464190|B2|Baseline|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
175172|NCT01464190|B1|Baseline|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
175173|NCT01464190|P2|Participant Flow|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
175174|NCT01464190|P1|Participant Flow|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day)
175175|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
175176|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
175177|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
175178|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
175179|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
175180|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
175181|NCT01464190|E2|Reported Event|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
175182|NCT01464190|E1|Reported Event|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
175183|NCT01464021|B1|Baseline|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175184|NCT01464021|P1|Participant Flow|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175185|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175186|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175187|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175188|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175189|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175190|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175191|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175192|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175193|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175194|NCT01464021|E1|Reported Event|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
175195|NCT01463982|B5|Baseline|Total|Total of all reporting groups
175196|NCT01463982|B4|Baseline|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175197|NCT01463982|B3|Baseline|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175198|NCT01463982|B2|Baseline|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175199|NCT01463982|B1|Baseline|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175966|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
175200|NCT01463982|P4|Participant Flow|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175201|NCT01463982|P3|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175202|NCT01463982|P2|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175203|NCT01463982|P1|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175204|NCT01463982|O4|Outcome|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175205|NCT01463982|O3|Outcome|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175206|NCT01463982|O2|Outcome|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175207|NCT01463982|O1|Outcome|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175208|NCT01463982|O4|Outcome|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175209|NCT01463982|O3|Outcome|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175210|NCT01463982|O2|Outcome|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175211|NCT01463982|O1|Outcome|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175212|NCT01463982|E4|Reported Event|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175213|NCT01463982|E3|Reported Event|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175214|NCT01463982|E2|Reported Event|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175215|NCT01463982|E1|Reported Event|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
175216|NCT01463878|B3|Baseline|Total|Total of all reporting groups
175217|NCT01463878|B2|Baseline|Control - Jevity|The control arm of the study. Patients to receive Jevity
175218|NCT01463878|B1|Baseline|Glycerna|Diabetic specific formula
175219|NCT01463878|P2|Participant Flow|Control - Jevity|The control arm of the study. Patients to receive Jevity
175220|NCT01463878|P1|Participant Flow|Glycerna|Diabetic specific formula
175221|NCT01463878|O2|Outcome|Control - Jevity|The control arm of the study. Patients to receive Jevity
175222|NCT01463878|O1|Outcome|Glycerna|Diabetic specific formula
175223|NCT01463878|E2|Reported Event|Control - Jevity|The control arm of the study. Patients to receive Jevity
175224|NCT01463878|E1|Reported Event|Glycerna|Diabetic specific formula
175225|NCT01463696|B9|Baseline|Total|Total of all reporting groups
175226|NCT01463696|B8|Baseline|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
175227|NCT01463696|B7|Baseline|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
175228|NCT01463696|B6|Baseline|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
175229|NCT01463696|B5|Baseline|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
175230|NCT01463696|B4|Baseline|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
175231|NCT01463696|B3|Baseline|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
175232|NCT01463696|B2|Baseline|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
175233|NCT01463696|B1|Baseline|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
175234|NCT01463696|P8|Participant Flow|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
175235|NCT01463696|P7|Participant Flow|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
175236|NCT01463696|P6|Participant Flow|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
175237|NCT01463696|P5|Participant Flow|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
175238|NCT01463696|P4|Participant Flow|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
175239|NCT01463696|P3|Participant Flow|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
175240|NCT01463696|P2|Participant Flow|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
175241|NCT01463696|P1|Participant Flow|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered orally (PO) twice a day (BID) on Days 1-6 and PO once daily (QD) in the morning on Day 7 of the 21-day cycle to accommodate pharmacokinetic (PK) sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
175242|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
175243|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
175244|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
175245|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
175246|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
175247|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
175248|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
175249|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
175250|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
175251|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
175252|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
175307|NCT01463683|E1|Reported Event|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175253|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
175254|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
175255|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
175256|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
175257|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
175258|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
175259|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
175260|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
175261|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
175262|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
175263|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
175264|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
175265|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
175266|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
175267|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
175268|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
175269|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
175270|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
175271|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
175272|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
175273|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
175274|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
175348|NCT01463111|P1|Participant Flow|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.
Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
175275|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
175276|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
175277|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
175278|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
175279|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
175280|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
175281|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
175282|NCT01463696|E8|Reported Event|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
175283|NCT01463696|E7|Reported Event|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
175284|NCT01463696|E6|Reported Event|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
175285|NCT01463696|E5|Reported Event|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
175286|NCT01463696|E4|Reported Event|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
175287|NCT01463696|E3|Reported Event|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
175288|NCT01463696|E2|Reported Event|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
175289|NCT01463696|E1|Reported Event|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
175290|NCT01463683|B4|Baseline|Total|Total of all reporting groups
175291|NCT01463683|B3|Baseline|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
175292|NCT01463683|B2|Baseline|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175293|NCT01463683|B1|Baseline|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175294|NCT01463683|P3|Participant Flow|V232-2XP Intramuscular (IM)|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
175295|NCT01463683|P2|Participant Flow|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175296|NCT01463683|P1|Participant Flow|V232-2XP Subcutaneous (SC)|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175297|NCT01463683|O3|Outcome|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
175298|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175299|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175300|NCT01463683|O3|Outcome|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
175301|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175302|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175303|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175304|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175305|NCT01463683|E3|Reported Event|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
175306|NCT01463683|E2|Reported Event|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
175308|NCT01462773|B1|Baseline|Treatment (Enzyme Inhibitor, Interferon Therapy)|Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22 and recombinant interferon alfa-2b SC on days 1, 3, and 5 (days 1 and 3 only in week 4 course 1) of weeks 1-4. Treatment repeats every 5 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
175309|NCT01462773|P1|Participant Flow|Bortezomib & Interferon-a|Bortezomib was administered intravenously weekly along with IFN-a thrice weekly.
175310|NCT01462773|O1|Outcome|Bortezomib & Interferon-a|Bortezomib was administered intravenously weekly along with IFN-a thrice weekly.
175311|NCT01462773|O1|Outcome|Bortezomib & Interferon-a|Patients were treated on a 5-week cycle. Week 1 of cycle 1, patients received 5 million U/m(2) IFN-a subcutaneously thrice weekly. Weeks 2-4 of cycle 1, bortezomib was administered intravenously weely along with IFN-a thrice weekly. A break from treatment during week 5. Folllowing cycle 1, bortezomib was administered in combination iwth IFN-a. Bortezomib was administered in escalating doses to cohorts of 3 patients.
175312|NCT01462773|E1|Reported Event|Treatment (Enzyme Inhibitor, Interferon Therapy)|Patients were treated on a 5-week cycle. In week 1 of cycle 1, patients received 5 million U/m(2) IFN-α subcutaneously thrice weekly. During weeks 2-4 of cycle 1, bortezomib was administered intravenously weekly along with IFN-α thrice weekly. There was a treatment break during week 5. After cycle 1, bortezomib was administered in combination with IFN-α. Bortezomib was administered in escalating doses (1.0, 1.3, or 1.6 mg/m) to cohorts of 3 patients.
175313|NCT01463527|B3|Baseline|Total|Total of all reporting groups
175314|NCT01463527|B2|Baseline|Capnography Blind|Staff members were blinded to screen on capnography monitor and all alarms turned off for the sedation.
175315|NCT01463527|B1|Baseline|Open Capnography|Staff members able to view capnography monitor during sedation.
175316|NCT01463527|P2|Participant Flow|Capnography Blind|Staff members blinded to capnography screen and alarms turned off during sedation.
175317|NCT01463527|P1|Participant Flow|Open Capnography|Staff members able to view capnography monitor during sedation.
175318|NCT01463527|O2|Outcome|Capnography Blind|Staff blinded to capnography screen and alarms turned off during sedation.
175319|NCT01463527|O1|Outcome|Open Capnography|Staff able to view capnography monitor during sedation.
175320|NCT01463527|E2|Reported Event|Capnography Blind|Nellcor NPB-70 Capnograph: Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
175321|NCT01463527|E1|Reported Event|Open Capnography|Nellcor NPB-70 Capnograph: Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
175322|NCT01463384|B1|Baseline|Minocycline|Subjects administered 50mg minocycline twice daily for 6 months
175323|NCT01463384|P1|Participant Flow|Minocycline|Subjects were administered 50mg minocycline twice daily for 6 months
175324|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
175325|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
175326|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
175327|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
175328|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
175329|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
175330|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
175331|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
175332|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
175333|NCT01463384|E1|Reported Event|Minocycline|No adverse events were reported in any subjects who were taking minocycline. All subjects underwent monthly blood tests to monitor alanine transaminase and blood urea nitrogen levels.
175334|NCT01463293|B4|Baseline|Total|Total of all reporting groups
175335|NCT01463293|B3|Baseline|Placebo|"Placebo capsule
Placebo: Capsule containing no probiotic once a day"
175336|NCT01463293|B2|Baseline|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
175337|NCT01463293|B1|Baseline|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
175338|NCT01463293|P3|Participant Flow|Placebo|"Placebo capsule
Placebo: Capsule containing no probiotic once a day"
175339|NCT01463293|P2|Participant Flow|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
175340|NCT01463293|P1|Participant Flow|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
175341|NCT01463293|O3|Outcome|Placebo|"Placebo capsule
Placebo: Capsule containing no probiotic once a day"
175342|NCT01463293|O2|Outcome|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
175343|NCT01463293|O1|Outcome|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
175344|NCT01463293|E3|Reported Event|Placebo|"Placebo capsule
Placebo: Capsule containing no probiotic once a day"
175345|NCT01463293|E2|Reported Event|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
175346|NCT01463293|E1|Reported Event|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019
B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
175347|NCT01463111|B1|Baseline|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.
Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
175381|NCT01462942|P1|Participant Flow|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175349|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.
Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
175350|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.
Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
175351|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.
Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
175352|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.
Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
175353|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.
Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
175354|NCT01463111|E1|Reported Event|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.
Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
175355|NCT01463033|B3|Baseline|Total|Total of all reporting groups
175356|NCT01463033|B2|Baseline|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
175357|NCT01463033|B1|Baseline|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
175358|NCT01463033|P2|Participant Flow|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
175359|NCT01463033|P1|Participant Flow|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
175360|NCT01463033|O1|Outcome|Participants|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. schedule were monitored for adverse events through the 30 day treatment period.
175361|NCT01463033|O2|Outcome|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
175362|NCT01463033|O1|Outcome|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
175363|NCT01463033|E2|Reported Event|Observational|Adverse events were not monitored for the Observational group
175364|NCT01463033|E1|Reported Event|Levetiracetam|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
175365|NCT01463007|B1|Baseline|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
175366|NCT01463007|P1|Participant Flow|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
175367|NCT01463007|O1|Outcome|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
175368|NCT01463007|O2|Outcome|Extended to 5 Years of Follow Up-Rhode Island Hospital Only|Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.
175369|NCT01463007|O1|Outcome|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
175370|NCT01463007|E1|Reported Event|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
175371|NCT01462942|B6|Baseline|Total|Total of all reporting groups
175372|NCT01462942|B5|Baseline|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175373|NCT01462942|B4|Baseline|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175374|NCT01462942|B3|Baseline|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175375|NCT01462942|B2|Baseline|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175376|NCT01462942|B1|Baseline|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175377|NCT01462942|P5|Participant Flow|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175378|NCT01462942|P4|Participant Flow|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175379|NCT01462942|P3|Participant Flow|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175380|NCT01462942|P2|Participant Flow|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175382|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175383|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175384|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175385|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175386|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175387|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175388|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175389|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175390|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175391|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175392|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175393|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175394|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175395|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175396|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175397|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175398|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175399|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175400|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175401|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
175402|NCT01462942|E5|Reported Event|Formoterol 12 μg|
175403|NCT01462942|E4|Reported Event|Aclidinium 400 μg|
175404|NCT01462942|E3|Reported Event|Aclidinium/Formoterol 400/6 μg|
175405|NCT01462942|E2|Reported Event|Aclidinium/Formoterol 400/12 μg|
175406|NCT01462942|E1|Reported Event|Placebo|
175407|NCT01462929|B4|Baseline|Total|Total of all reporting groups
175408|NCT01462929|B3|Baseline|Placebo|"Placebo
Route of administration:
Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
175409|NCT01462929|B2|Baseline|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily
Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.
Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)
AND
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
175410|NCT01462929|B1|Baseline|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day
Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.
Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
AND
1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
175411|NCT01462929|P3|Participant Flow|Placebo|"Placebo
Route of administration:
Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
175412|NCT01462929|P2|Participant Flow|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily
Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.
Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)
AND
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
175413|NCT01462929|P1|Participant Flow|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day
Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.
Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
AND
1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
175414|NCT01462929|O3|Outcome|Placebo|"Placebo
Route of administration:
Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
175415|NCT01462929|O2|Outcome|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily
Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.
Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)
AND
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
175511|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175416|NCT01462929|O1|Outcome|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day
Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.
Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
AND
1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
175417|NCT01462929|O3|Outcome|Placebo|"Placebo
Route of administration:
Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
175418|NCT01462929|O2|Outcome|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily
Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.
Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)
AND
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
175419|NCT01462929|O1|Outcome|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day
Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.
Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
AND
1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
175420|NCT01462929|E3|Reported Event|Placebo|"Placebo
Route of administration:
Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
175421|NCT01462929|E2|Reported Event|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily
Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.
Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)
AND
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
175422|NCT01462929|E1|Reported Event|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day
Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.
Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
AND
1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
175423|NCT01462877|B1|Baseline|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175424|NCT01462877|P1|Participant Flow|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175425|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175426|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175427|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175428|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175429|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175430|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175431|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175432|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175433|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175434|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175435|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175436|NCT01462877|E1|Reported Event|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
175437|NCT01462812|B3|Baseline|Total|Total of all reporting groups
175438|NCT01462812|B2|Baseline|Sumatriptan|Sumatriptan : Sumatriptan 20mg
175439|NCT01462812|B1|Baseline|Matching Placebo|Placebo : Matching placebo
175440|NCT01462812|P2|Participant Flow|Sumatriptan|Sumatriptan : Sumatriptan 20mg
175441|NCT01462812|P1|Participant Flow|Matching Placebo|Placebo : Matching placebo
175442|NCT01462812|O2|Outcome|Sumatriptan|Sumatriptan : Sumatriptan 20mg
175443|NCT01462812|O1|Outcome|Matching Placebo|Placebo : Matching placebo
175444|NCT01462812|E2|Reported Event|Sumatriptan|Sumatriptan : Sumatriptan 20mg
175445|NCT01462812|E1|Reported Event|Matching Placebo|Placebo : Matching placebo
175446|NCT01462695|B3|Baseline|Total|Total of all reporting groups
175447|NCT01462695|B2|Baseline|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO
diagnostic laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
175448|NCT01462695|B1|Baseline|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO
diagnostic laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
175449|NCT01462695|P2|Participant Flow|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO
diagnostic laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
175450|NCT01462695|P1|Participant Flow|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO
diagnostic laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
175451|NCT01462695|O2|Outcome|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO
diagnostic laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
175452|NCT01462695|O1|Outcome|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO
diagnostic laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
175453|NCT01462695|E2|Reported Event|Stratum B: Recurrent Ependymoma|Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
175454|NCT01462695|E1|Reported Event|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO
diagnostic laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
175455|NCT01462435|B5|Baseline|Total|Total of all reporting groups
175456|NCT01462435|B4|Baseline|Placebo|Placebo : Capsules
175457|NCT01462435|B3|Baseline|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
175458|NCT01462435|B2|Baseline|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
175459|NCT01462435|B1|Baseline|Celecoxib|Celecoxib : 200 mg Capsules
175460|NCT01462435|P4|Participant Flow|Placebo|Placebo : Capsules
175461|NCT01462435|P3|Participant Flow|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
175462|NCT01462435|P2|Participant Flow|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
175463|NCT01462435|P1|Participant Flow|Celecoxib|Celecoxib : 200 mg Capsules
175464|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
175465|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
175466|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
175467|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
175468|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
175469|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
175470|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
175471|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
175472|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
175473|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
175474|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
175475|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
175476|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
175477|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
175478|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
175479|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
175480|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
175481|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
175482|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
175483|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
175484|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
175485|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
175486|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
175487|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
175488|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
175489|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
175490|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
175491|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
175492|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
175493|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
175494|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
175495|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
175496|NCT01462435|E4|Reported Event|Placebo|Placebo : Capsules
175497|NCT01462435|E3|Reported Event|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
175498|NCT01462435|E2|Reported Event|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
175499|NCT01462435|E1|Reported Event|Celecoxib|Celecoxib : 200 mg Capsules
175500|NCT01462370|B1|Baseline|All Randomized Participants|All participants randomized into the study.
175501|NCT01462370|P2|Participant Flow|Ibuprofen Up to 2400 mg / Etoricoxib 120 mg|Ibuprofen 600 mg given orally up to for times a day as needed for a maximum of 2400 mg/day in menstrual cyle 1. In menstrual cycle 2, etoricoxib 120 mg ws given orally for one dose.
175502|NCT01462370|P1|Participant Flow|Etoricoxib 120 mg/ Ibuprofen Up to 2400 mg|Etoricoxib 120 mg tablet given orally or one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.
175503|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175504|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175505|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175506|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175507|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175508|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175509|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175510|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175513|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175514|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175515|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175516|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175517|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175518|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175519|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175520|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175521|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175522|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175523|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175524|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175525|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175526|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175527|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175528|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175529|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
175530|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
175531|NCT01462370|E2|Reported Event|Ibuprofen up to 2400 mg / Etoricoxib 120 mg|Ibuprofen 600 mg given orally up to four times a day as needed, for a maximum of 2400 mg/day in menstrual cycle 1. In menstrual cycle 2, etoricoxib was administered at a dose of 120 mg daily.
175532|NCT01462370|E1|Reported Event|Etoricoxib 120 mg / Ibuprofen up to 2400 mg/Daily|Etoricoxib 120 mg tablet given orally for one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.
175533|NCT01462357|B4|Baseline|Total|Total of all reporting groups
175534|NCT01462357|B3|Baseline|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175535|NCT01462357|B2|Baseline|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175536|NCT01462357|B1|Baseline|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175537|NCT01462357|P3|Participant Flow|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175538|NCT01462357|P2|Participant Flow|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175539|NCT01462357|P1|Participant Flow|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175540|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175541|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175542|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175543|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175544|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175545|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175546|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175547|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175548|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175967|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
175549|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175550|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175551|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175552|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175553|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175554|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175555|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175556|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175557|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175558|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175559|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175560|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175561|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175562|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175563|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175564|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175565|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175566|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175567|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175568|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175569|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175570|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175571|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175572|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175573|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175574|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175575|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175576|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175889|NCT01461551|E1|Reported Event|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
175577|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175578|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175579|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175580|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175581|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175582|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175583|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175584|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175585|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175586|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175587|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175588|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175589|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175590|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175591|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175592|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175593|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175594|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175595|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175596|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175597|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175598|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175599|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175600|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175601|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175602|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175603|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175604|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175890|NCT01461538|B4|Baseline|Total|Total of all reporting groups
175995|NCT01461057|B3|Baseline|Total|Total of all reporting groups
175605|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175606|NCT01462357|E3|Reported Event|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175607|NCT01462357|E2|Reported Event|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175608|NCT01462357|E1|Reported Event|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
175609|NCT01462344|B3|Baseline|Total|Total of all reporting groups
175610|NCT01462344|B2|Baseline|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
175611|NCT01462344|B1|Baseline|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
175612|NCT01462344|P2|Participant Flow|Fluticasone Propionate (FP)|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
175613|NCT01462344|P1|Participant Flow|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
175614|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
175615|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
175616|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
175617|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
175618|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
175619|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
175685|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175620|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
175621|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
175622|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
175623|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
175624|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
175625|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
175626|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
175627|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
175628|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
175629|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
175630|NCT01462344|E2|Reported Event|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
175631|NCT01462344|E1|Reported Event|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
175632|NCT01462318|B3|Baseline|Total|Total of all reporting groups
175806|NCT01461980|E3|Reported Event|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
175633|NCT01462318|B2|Baseline|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.
In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
175634|NCT01462318|B1|Baseline|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.
Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
175635|NCT01462318|P3|Participant Flow|Extension Phase|After completion of the washout period from the Main Study or the TP-DI sub-study, eligible participants had the option to resume monthly open-label treatment with DAC HYP 150 mg in the extension phase of the study for up to 3 additional years.
175636|NCT01462318|P2|Participant Flow|Therapeutic Protein-Drug Interaction (TP-DI)Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.
In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
175637|NCT01462318|P1|Participant Flow|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.
Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
175638|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.
In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
175639|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.
In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
175640|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.
In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
175641|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.
Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
175642|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.
Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
175643|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.
Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
175644|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.
Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
175645|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.
Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
175646|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.
Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
175647|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.
Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
175807|NCT01461980|E2|Reported Event|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
175648|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.
In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
175649|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.
In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
175650|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.
Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
175651|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.
Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
175652|NCT01462318|E1|Reported Event|DAC HYP 150 mg|DAC HYP 150 mg by SC injection using the PFS every 4 weeks for24 weeks followed by a 20-week washout period. After completion of the washout period, participants could resume monthly DAC HYP 150 mg using the PFS for up to 3 additional years. Participants in the TP-DI sub-study received s probe-drug cocktail administration at Weeks 43 and 53. The probe-drug cocktail consisted of midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg. The oral vitamin K was used to counteract warfarin’s anticoagulant effect prophylactically.
175653|NCT01462279|B1|Baseline|Thiamine|"Open label - 200mg IV
Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
175654|NCT01462279|P1|Participant Flow|Thiamine|"Open label - 200mg IV
Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
175655|NCT01462279|O1|Outcome|Thiamine|"Open label - 200mg IV
Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
175656|NCT01462279|E1|Reported Event|Thiamine|"Open label - 200mg IV
Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
175657|NCT01462266|B3|Baseline|Total|Total of all reporting groups
175658|NCT01462266|B2|Baseline|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
175659|NCT01462266|B1|Baseline|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
175660|NCT01462266|P2|Participant Flow|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
175661|NCT01462266|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
175662|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
175663|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
175664|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
175665|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
175666|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
175667|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
175668|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
175669|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
175670|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
175671|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
175672|NCT01462266|E2|Reported Event|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
175673|NCT01462266|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
175674|NCT01462227|B3|Baseline|Total|Total of all reporting groups
175675|NCT01462227|B2|Baseline|Naltrexone (Higher Dose)|Naltrexone: Naltrexone 100mg, 1 tablet given every 12 hours orally
175676|NCT01462227|B1|Baseline|Naltrexone (Lower Dose)|Naltrexone: Naltrexone 50 mg, 1 tablet given every 12 hours orally
175677|NCT01462227|P4|Participant Flow|Placebo First / Naltrexone (Higher Dose) Second|Placebo given 12 hours prior to visit orally Naltrexone 100 mg (1 tablet) given at time of visit orally
175678|NCT01462227|P3|Participant Flow|Naltrexone (Higher Dose) First /Placebo Second|Naltrexone 100 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
175679|NCT01462227|P2|Participant Flow|Placebo First/ Naltrexone (Lower Dose) Second|Placebo given given 12 hours prior to visit orally Naltrexone 50 mg (1 tablet) given at time of visit orally
175680|NCT01462227|P1|Participant Flow|Naltrexone (Lower Dose) First /Placebo Second|Naltrexone 50 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
175681|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175682|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175683|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175684|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175686|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175687|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175688|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175689|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175690|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175691|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175692|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
175693|NCT01462227|E4|Reported Event|Placebo (Higher Dose)|Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
175694|NCT01462227|E3|Reported Event|Naltrexone (100 mg)|Naltrexone 100 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
175695|NCT01462227|E2|Reported Event|Placebo (Lower Dose Group)|Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
175696|NCT01462227|E1|Reported Event|Naltrexone (50 mg)|Naltrexone 50 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
175697|NCT01462162|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
175698|NCT01462162|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
175699|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175700|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175701|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175702|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175703|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175704|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175705|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175706|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175707|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175708|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175709|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175710|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175711|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175712|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175713|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175714|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175715|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175716|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175717|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175718|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175719|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175720|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
175721|NCT01462162|E1|Reported Event|All Participants|Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
175722|NCT01462084|B1|Baseline|Overall Study Population|All study patients included in final analysis.
175723|NCT01462084|P2|Participant Flow|Bi-Level PAP|Bi-level PAP delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so patients in this arm used Bi-Level PAP therapy the first night and then crossed over and used ASV the second night.
175724|NCT01462084|P1|Participant Flow|Adaptive Servo-ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so patients in this arm used ASV therapy the first night and then crossed over and used BiLevel PAP the second night.
175725|NCT01462084|O2|Outcome|Bi-Level PAP|Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
175726|NCT01462084|O1|Outcome|Adaptive Servo-ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. Both pressures are fixed and do not adjust based on the individuals breathing events.
175727|NCT01462084|O2|Outcome|Bi-Level PAP|Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
175728|NCT01462084|O1|Outcome|Adaptive Servo-Ventilation (ASV)|All patients received 1 night of therapy using Adaptive servo-ventilation (ASV) and 1 night of therapy using Bi-level PAP. Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
175886|NCT01461551|O1|Outcome|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
175729|NCT01462084|E2|Reported Event|Bi-Level PAP|Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
175730|NCT01462084|E1|Reported Event|Adaptive Servo-Ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
175731|NCT01462045|B4|Baseline|Total|Total of all reporting groups
175732|NCT01462045|B3|Baseline|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
175733|NCT01462045|B2|Baseline|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
175734|NCT01462045|B1|Baseline|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
175735|NCT01462045|P3|Participant Flow|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
175736|NCT01462045|P2|Participant Flow|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
175737|NCT01462045|P1|Participant Flow|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
175738|NCT01462045|O3|Outcome|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
175739|NCT01462045|O2|Outcome|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
175740|NCT01462045|O1|Outcome|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
175741|NCT01462045|O3|Outcome|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
175742|NCT01462045|O2|Outcome|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
175743|NCT01462045|O1|Outcome|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
175744|NCT01462045|E3|Reported Event|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
175745|NCT01462045|E2|Reported Event|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
175746|NCT01462045|E1|Reported Event|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
175747|NCT01461993|B4|Baseline|Total|Total of all reporting groups
175748|NCT01461993|B3|Baseline|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175749|NCT01461993|B2|Baseline|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
175750|NCT01461993|B1|Baseline|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175751|NCT01461993|P3|Participant Flow|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175752|NCT01461993|P2|Participant Flow|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
175753|NCT01461993|P1|Participant Flow|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175754|NCT01461993|O3|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175755|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
175756|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175757|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
175758|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175759|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
175760|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175761|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
175762|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175763|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175764|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175765|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175766|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175767|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
175768|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175769|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175770|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175771|NCT01461993|E3|Reported Event|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175772|NCT01461993|E2|Reported Event|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
175773|NCT01461993|E1|Reported Event|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
175774|NCT01461980|B4|Baseline|Total|Total of all reporting groups
175775|NCT01461980|B3|Baseline|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
175776|NCT01461980|B2|Baseline|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
175887|NCT01461551|E3|Reported Event|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
175777|NCT01461980|B1|Baseline|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175778|NCT01461980|P3|Participant Flow|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
175779|NCT01461980|P2|Participant Flow|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
175780|NCT01461980|P1|Participant Flow|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175781|NCT01461980|O3|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
175782|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
175783|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175784|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
175785|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175786|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
175787|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175788|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
175789|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175790|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
175791|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175792|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
175793|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175794|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
175795|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175796|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
175797|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175798|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
175799|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175800|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
175801|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175802|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
175803|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175804|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
175805|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175958|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
175808|NCT01461980|E1|Reported Event|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
175809|NCT01461811|B3|Baseline|Total|Total of all reporting groups
175810|NCT01461811|B2|Baseline|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175811|NCT01461811|B1|Baseline|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175812|NCT01461811|P2|Participant Flow|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175813|NCT01461811|P1|Participant Flow|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175814|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175815|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175816|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175817|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175818|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175819|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175820|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175821|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175822|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175823|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175824|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175825|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175826|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175827|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175828|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175829|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175830|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175831|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175832|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175833|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175834|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175835|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175836|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175837|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175838|NCT01461811|E2|Reported Event|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
175839|NCT01461811|E1|Reported Event|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
175840|NCT01461733|B3|Baseline|Total|Total of all reporting groups
175841|NCT01461733|B2|Baseline|Placebo|Placebo: placebo delivered blinded
175842|NCT01461733|B1|Baseline|Amiodarone|"standard dose amiodarone
amiodarone: standard dose amiodarone"
175843|NCT01461733|P2|Participant Flow|Placebo|
175844|NCT01461733|P1|Participant Flow|Amiodarone|standard dose amiodarone
175845|NCT01461733|O2|Outcome|Placebo|Placebo: placebo delivered blinded
175846|NCT01461733|O1|Outcome|Amiodarone|"standard dose amiodarone
amiodarone: standard dose amiodarone"
175847|NCT01461733|E2|Reported Event|Placebo|Placebo: placebo delivered blinded
175848|NCT01461733|E1|Reported Event|Amiodarone|"standard dose amiodarone
amiodarone: standard dose amiodarone"
175849|NCT01461707|B3|Baseline|Total|Total of all reporting groups
175850|NCT01461707|B2|Baseline|Activity Monitor Group|Participants in the group will receive an activity monitor
175888|NCT01461551|E2|Reported Event|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
175851|NCT01461707|B1|Baseline|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor
Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
175852|NCT01461707|P2|Participant Flow|Activity Monitor Group|Participants in the group will receive an activity monitor
175853|NCT01461707|P1|Participant Flow|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor
Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
175854|NCT01461707|O2|Outcome|Activity Monitor Group|Participants in the group will receive an activity monitor
175855|NCT01461707|O1|Outcome|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor
Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
175856|NCT01461707|O2|Outcome|Activity Monitor Group|Participants in the group will receive an activity monitor
175857|NCT01461707|O1|Outcome|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor
Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
175858|NCT01461707|E2|Reported Event|Activity Monitor Group|Participants in the group will receive an activity monitor
175859|NCT01461707|E1|Reported Event|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor
Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
175860|NCT01461655|B1|Baseline|Topical Retinoid - Placebo, Topical Retinoid - NSAID|"marketed topical retinoid : once daily application, 4 weeks
vehicle gel : once daily application, 4 weeks"
175861|NCT01461655|P1|Participant Flow|Topical Retinoid - Placebo, Topical Retinoid - NSAID|"Using a left-right split face set up, the study evaluated the effect of sequential application of topical retinoid 0.1% gel and NSAID 5% gel in comparison with the sequential application of topical retinoid 0.1% gel and vehicle gel for the treatment of acne vulgaris.
The randomised subjects received the following products:
NSAID 5% gel , in the morning on the appropriate hemiface.
Topical retinoid 0.1% gel, in the evening on the entire face.
Vehicle gel, in the morning on the appropriate hemiface."
175862|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks
marketed topical retinoid : once daily application, 4 weeks"
175863|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks
vehicle gel : once daily application, 4 weeks"
175864|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks
marketed topical retinoid : once daily application, 4 weeks"
175865|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks
vehicle gel : once daily application, 4 weeks"
175866|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks
marketed topical retinoid : once daily application, 4 weeks"
175867|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks
vehicle gel : once daily application, 4 weeks"
175868|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks
marketed topical retinoid : once daily application, 4 weeks"
175869|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks
vehicle gel : once daily application, 4 weeks"
175870|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks
marketed topical retinoid : once daily application, 4 weeks"
175871|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks
vehicle gel : once daily application, 4 weeks"
175872|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks
marketed topical retinoid : once daily application, 4 weeks"
175873|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks
vehicle gel : once daily application, 4 weeks"
175874|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks
marketed topical retinoid : once daily application, 4 weeks"
175875|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks
vehicle gel : once daily application, 4 weeks"
175876|NCT01461655|E1|Reported Event|Topical Retinoid - Placebo, Topical Retinoid - NSAID|
175877|NCT01461551|B4|Baseline|Total|Total of all reporting groups
175878|NCT01461551|B3|Baseline|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
175879|NCT01461551|B2|Baseline|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
175880|NCT01461551|B1|Baseline|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
175881|NCT01461551|P3|Participant Flow|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
175882|NCT01461551|P2|Participant Flow|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
175883|NCT01461551|P1|Participant Flow|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
175884|NCT01461551|O3|Outcome|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
175885|NCT01461551|O2|Outcome|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
175959|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
175891|NCT01461538|B3|Baseline|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
175892|NCT01461538|B2|Baseline|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175893|NCT01461538|B1|Baseline|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175894|NCT01461538|P3|Participant Flow|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
175895|NCT01461538|P2|Participant Flow|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175896|NCT01461538|P1|Participant Flow|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175897|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
175898|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175899|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175900|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
175901|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175902|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175903|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
175904|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175905|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175906|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
175907|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175908|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175909|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
175910|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175911|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175912|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
175913|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175914|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175915|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
175916|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175917|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175918|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
175919|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
175920|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
175921|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
175922|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
175923|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
175924|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
175925|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
175926|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
175927|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
175928|NCT01461538|E3|Reported Event|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
175929|NCT01461538|E2|Reported Event|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175930|NCT01461538|E1|Reported Event|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
175931|NCT01461473|B3|Baseline|Total|Total of all reporting groups
175960|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
175932|NCT01461473|B2|Baseline|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
175933|NCT01461473|B1|Baseline|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
175934|NCT01461473|P2|Participant Flow|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
175935|NCT01461473|P1|Participant Flow|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
175936|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
175937|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
175938|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
175939|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
175940|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
175941|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
175942|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
175943|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
175944|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
175945|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
175946|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
175947|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
175948|NCT01461473|E2|Reported Event|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
175949|NCT01461473|E1|Reported Event|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
175950|NCT01461369|B4|Baseline|Total|Total of all reporting groups
175951|NCT01461369|B3|Baseline|Placebo|Placebo: Capsule
175952|NCT01461369|B2|Baseline|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
175953|NCT01461369|B1|Baseline|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
175954|NCT01461369|P3|Participant Flow|Placebo|Placebo: Capsule
175955|NCT01461369|P2|Participant Flow|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
175956|NCT01461369|P1|Participant Flow|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
175957|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
175970|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
175971|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
175972|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
175973|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
175974|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
175975|NCT01461369|E3|Reported Event|Placebo|Placebo: Capsule
175976|NCT01461369|E2|Reported Event|Diclofenac 35 mg Three Times Daily|Diclofenac Test (three times daily): Capsules
175977|NCT01461369|E1|Reported Event|Diclofenac 35 mg Two Times Daily|Diclofenac Test (two times daily): Capsules
175978|NCT01461096|B3|Baseline|Total|Total of all reporting groups
175979|NCT01461096|B2|Baseline|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.
Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175980|NCT01461096|B1|Baseline|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175981|NCT01461096|P2|Participant Flow|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.
Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175982|NCT01461096|P1|Participant Flow|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175983|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.
Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175984|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175985|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.
Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175986|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175987|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.
Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175988|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175989|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.
Placebo Vaccine for Male Participants Only: Participants were prescribed IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175990|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175991|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.
Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175992|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175993|NCT01461096|E2|Reported Event|Placebo|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.
Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
175994|NCT01461096|E1|Reported Event|qHPV|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
176240|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
175996|NCT01461057|B2|Baseline|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
175997|NCT01461057|B1|Baseline|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
175998|NCT01461057|P2|Participant Flow|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
175999|NCT01461057|P1|Participant Flow|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
176000|NCT01461057|O2|Outcome|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
176001|NCT01461057|O1|Outcome|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
176002|NCT01461057|O2|Outcome|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
176003|NCT01461057|O1|Outcome|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
176004|NCT01461057|E2|Reported Event|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
176005|NCT01461057|E1|Reported Event|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
176006|NCT01461044|B3|Baseline|Total|Total of all reporting groups
176007|NCT01461044|B2|Baseline|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176008|NCT01461044|B1|Baseline|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176239|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
176009|NCT01461044|P2|Participant Flow|Bevacizumab: Triple Negative (TN) Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176010|NCT01461044|P1|Participant Flow|Bevacizumab: Hormone Receptor-Positive (HR+) Breast Cancer|Participants with human epidermal growth factor receptor 2 negative (HER2-) metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for greater than or equal to (>=) 12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176011|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176012|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176013|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176014|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176015|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176016|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176017|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176018|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176019|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176020|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176138|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176021|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176022|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176023|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176024|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176025|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176026|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176027|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176028|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176029|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176030|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176031|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176032|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176139|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176033|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176034|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176035|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176036|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176037|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HR+ cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months.
176038|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176039|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176040|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176041|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176042|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176043|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176044|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176140|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176584|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176045|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176046|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176047|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176048|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176049|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176050|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176051|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176052|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176053|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176054|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176055|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176056|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176141|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176057|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176058|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176059|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176060|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176061|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176062|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176063|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176064|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176065|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176066|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176067|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176068|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176069|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176236|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
176070|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176071|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176072|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176073|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176074|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176075|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176076|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176077|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176078|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176079|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176080|NCT01461044|E2|Reported Event|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176081|NCT01461044|E1|Reported Event|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
176082|NCT01460940|B1|Baseline|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.
panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.
lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
176083|NCT01460940|P1|Participant Flow|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.
panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.
lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
177336|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
176084|NCT01460940|O1|Outcome|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.
panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.
lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
176085|NCT01460940|O1|Outcome|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.
panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.
lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
176086|NCT01460940|O1|Outcome|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.
panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.
lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
176087|NCT01460940|E1|Reported Event|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.
panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.
lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
176088|NCT01460927|B1|Baseline|TriActive+ RF|Healthy male or female subjects 30-60 years of age, having at least two facial sub-areas (left peri-orbital, right peri-orbital or peri-oral) with visible lines/wrinkles and elastosis, which correlate to a score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
176089|NCT01460927|P1|Participant Flow|TriActive+RF|"Subjects will receive up to 8 treatments on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2days) with evaluation follow-up visits at one (1) week (±2days), one (1) month (±4days), and three (3) months (±4days) following the final treatment. The treatments start at a low power (3W for the small tip, 10W for the medium and large tips) and then gradually increase the setting up to the highest powers available within the tips, checking the subject’s tolerability and reaction of the tissue.
The power is adjusted to suit the subject’s sensitivity and the “depth” of tissue to be treated (deeper tissue requires the larger tip). The goal is to progressively and smoothly reach an epidermal temperature end-point of 43°C. The treatment end-point correlates directly with the measurement of the skin temperature.
The temperature of 43°C should be maintained at the end point for several minutes (3-5min)."
176090|NCT01460927|O5|Outcome|3 Month FU|3 Months after the 8th treatment
176091|NCT01460927|O4|Outcome|1 Month FU|1 Month after the 8th treatment
176092|NCT01460927|O3|Outcome|Pre Treatment 8|After 7 treatments
176093|NCT01460927|O2|Outcome|Pre Treatment 4|After 3 treatments
176094|NCT01460927|O1|Outcome|Baseline|Baseline (before Treatments)
176095|NCT01460927|E1|Reported Event|TriActive+RF|Subjects will receive up to 8 treatments with the TriActive+ RF on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2 days).
176096|NCT01460732|B1|Baseline|All Patients|All patients analyzed
176097|NCT01460732|P1|Participant Flow|All Patients|All patients analyzed
176098|NCT01460732|O2|Outcome|HBPM-Nocturnal|Dippers defined by HBPM-Nocturnal.
176099|NCT01460732|O1|Outcome|ABPM|Dippers defined by ABPM.
176100|NCT01460732|O1|Outcome|All Patients|All patients analyzed
176101|NCT01460732|O1|Outcome|All Patients|All patients analyzed
176102|NCT01460732|O1|Outcome|All Patients|All patients analyzed
176103|NCT01460732|O1|Outcome|All Patients|All patients analyzed
176104|NCT01460732|O1|Outcome|All Patients|All patients analyzed
176105|NCT01460732|O1|Outcome|All Patients|All patients analyzed
176106|NCT01460732|O1|Outcome|All Patients|All patients analyzed
176107|NCT01460732|O1|Outcome|All Patients|All patients analyzed
176108|NCT01460732|E1|Reported Event|All Patients|All patients analyzed
176109|NCT01460628|B1|Baseline|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
176110|NCT01460628|P1|Participant Flow|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
176111|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
176112|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
176113|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
176114|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
176115|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
176116|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
176117|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
176118|NCT01460628|E1|Reported Event|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
176119|NCT01460446|B3|Baseline|Total|Total of all reporting groups
176120|NCT01460446|B2|Baseline|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176121|NCT01460446|B1|Baseline|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176122|NCT01460446|P2|Participant Flow|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176123|NCT01460446|P1|Participant Flow|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176124|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176125|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176126|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176127|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176128|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176129|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176130|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176131|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176132|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176133|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176134|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176135|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176136|NCT01460446|O1|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176137|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176585|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176142|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176143|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176144|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176145|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176146|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176147|NCT01460446|E2|Reported Event|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176148|NCT01460446|E1|Reported Event|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
176149|NCT01460342|B3|Baseline|Total|Total of all reporting groups
176150|NCT01460342|B2|Baseline|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
176151|NCT01460342|B1|Baseline|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
176152|NCT01460342|P2|Participant Flow|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
176153|NCT01460342|P1|Participant Flow|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
176154|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
176155|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
176156|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
176157|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
176158|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
176159|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
176160|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
176161|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
176162|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
176163|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
176164|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
176165|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
176166|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
176167|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
176168|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
176169|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
176170|NCT01460342|E2|Reported Event|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
176171|NCT01460342|E1|Reported Event|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
176172|NCT01460290|B1|Baseline|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg/day and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study."
176173|NCT01460290|P1|Participant Flow|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
176174|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176175|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176176|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176177|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176178|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176179|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176180|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176181|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176182|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176183|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176184|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176185|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176186|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176187|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176188|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
176189|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
176190|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
176191|NCT01460290|E1|Reported Event|Asenapine|"12-weeks of open-label asenapine treatment
Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
176192|NCT01459913|B5|Baseline|Total|Total of all reporting groups
176193|NCT01459913|B4|Baseline|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
176194|NCT01459913|B3|Baseline|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
176195|NCT01459913|B2|Baseline|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176196|NCT01459913|B1|Baseline|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
176197|NCT01459913|P4|Participant Flow|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
176198|NCT01459913|P3|Participant Flow|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
176199|NCT01459913|P2|Participant Flow|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176200|NCT01459913|P1|Participant Flow|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.
176201|NCT01459913|O4|Outcome|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
176202|NCT01459913|O3|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
176237|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
176203|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176204|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
176205|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176206|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
176207|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176208|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
176209|NCT01459913|O5|Outcome|Telaprevir+Peg-IFN-alfa-2a, RBV (Total)|All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, up to 48 weeks.
176210|NCT01459913|O4|Outcome|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
176211|NCT01459913|O3|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
176212|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176213|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
176214|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176215|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
176216|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176238|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
176586|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176217|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
176218|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176219|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
176220|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176221|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
176222|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176223|NCT01459913|O1|Outcome|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
176224|NCT01459913|E4|Reported Event|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
176225|NCT01459913|E3|Reported Event|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
176226|NCT01459913|E2|Reported Event|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
176227|NCT01459913|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
176228|NCT01459796|B3|Baseline|Total|Total of all reporting groups
176229|NCT01459796|B2|Baseline|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
176230|NCT01459796|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
176231|NCT01459796|P2|Participant Flow|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
176232|NCT01459796|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51.
176233|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
176234|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
176235|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
176241|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
176242|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
176243|NCT01459796|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
176244|NCT01459796|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
176245|NCT01459796|E2|Reported Event|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
176246|NCT01459796|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.
176247|NCT01459783|B3|Baseline|Total|Total of all reporting groups
176248|NCT01459783|B2|Baseline|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.
Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
176249|NCT01459783|B1|Baseline|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.
Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
176250|NCT01459783|P2|Participant Flow|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.
Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
176251|NCT01459783|P1|Participant Flow|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.
Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
176252|NCT01459783|O2|Outcome|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.
Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
176264|NCT01459705|P1|Participant Flow|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.
Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
176499|NCT01458951|P1|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176311|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN
176253|NCT01459783|O1|Outcome|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.
Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
176254|NCT01459783|O2|Outcome|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.
Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
176255|NCT01459783|O1|Outcome|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.
Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
176256|NCT01459783|E2|Reported Event|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.
Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
176257|NCT01459783|E1|Reported Event|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.
Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
176258|NCT01459705|B4|Baseline|Total|Total of all reporting groups
176259|NCT01459705|B3|Baseline|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.
Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
176260|NCT01459705|B2|Baseline|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.
Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
176261|NCT01459705|B1|Baseline|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.
Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
176262|NCT01459705|P3|Participant Flow|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.
Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
176263|NCT01459705|P2|Participant Flow|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.
Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
176582|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176265|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.
Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
176266|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.
Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
176267|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.
Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
176268|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.
Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
176269|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.
Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
176270|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.
Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
176271|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.
Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
176272|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.
Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
176273|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.
Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
176274|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.
Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
176275|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.
Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
176276|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.
Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
176277|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.
Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
176278|NCT01459705|E3|Reported Event|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.
Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
176309|NCT01459653|O2|Outcome|EP2006: Correctly Treated|Correctly treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176310|NCT01459653|O1|Outcome|EP2006: Undertreated|Undertreated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176279|NCT01459705|E2|Reported Event|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.
Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
176280|NCT01459705|E1|Reported Event|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.
Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
176281|NCT01459653|B1|Baseline|EP2006, Evaluable Sample|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Only patients who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data) belong to the evaluable sample and are analyzed.
176282|NCT01459653|P1|Participant Flow|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176283|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN
176284|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176285|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176286|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176287|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN
176288|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176289|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176290|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176291|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176292|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176293|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176294|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176295|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176296|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176297|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176298|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176299|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176300|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176301|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176302|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176303|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176304|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176305|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176306|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176307|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176308|NCT01459653|O3|Outcome|EP2006: Over Treated|Over treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
196723|NCT01385995|B2|Baseline|Sham-Continuous Positive Airway Pressure|
176312|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
176313|NCT01459653|O2|Outcome|EP2006: No CIN/FN-related Chemotherapy Disturbance|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had no CIN/FN-related chemotherapy disturbance
176314|NCT01459653|O1|Outcome|EP2006: Any CIN/FN-related Chemotherapy Disturbance|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had any CIN/FN-related chemotherapy disturbance
176315|NCT01459653|O2|Outcome|EP2006: No Grade 4 CIN/FN|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with no grade 4 CIN/FN
176316|NCT01459653|O1|Outcome|EP2006: Any Grade 4 CIN/FN|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with any grade 4 CIN/FN
176317|NCT01459653|O2|Outcome|EP2006: no CIN/FN-related Chemotherapy Disturbance|Cancer patients having no CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176318|NCT01459653|O1|Outcome|EP2006: Any CIN/FN-related Chemotherapy Disturbance|Cancer patients having any CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176319|NCT01459653|O2|Outcome|EP2006: No Grade 4 CIN/FN|Cancer patients with no grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176320|NCT01459653|O1|Outcome|EP2006: Any Grade 4 CIN/FN|Cancer patients with any grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176321|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176322|NCT01459653|O3|Outcome|EP2006: >=6 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with >=6 days of study drug duration.
176323|NCT01459653|O2|Outcome|EP2006: 4-5 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 4-5 days of study drug duration.
176324|NCT01459653|O1|Outcome|EP2006: 1-3 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 1-3 days of study drug duration.
176325|NCT01459653|O3|Outcome|EP2006: Day 4 or Later|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 4 or later
176326|NCT01459653|O2|Outcome|EP2006: Days 1-3 (Per Guidelines)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on days 1-3 (per guidelines)
176327|NCT01459653|O1|Outcome|EP2006: Day 0 (During Chemotherapy)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 0 (during chemotherapy)
176328|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176329|NCT01459653|O3|Outcome|EP2006: Mean GIS 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 1
176330|NCT01459653|O2|Outcome|EP2006: Mean GIS 0.51-0.99|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0.51-0.99
176331|NCT01459653|O1|Outcome|EP2006: Mean GIS 0-0.5|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0-0.5
176332|NCT01459653|O2|Outcome|EP2006: 48MIU/Day|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 48MIU/day
176333|NCT01459653|O1|Outcome|EP2006: 30MIU/Day|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 30MIU/day
176334|NCT01459653|O3|Outcome|EP2006: Overtreated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, overtreated relative to guidelines.
176335|NCT01459653|O2|Outcome|EP2006: Correctly Treated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, correctly treated relative to guidelines
176336|NCT01459653|O1|Outcome|EP2006: Undertreated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, undertreated relative to guidelines
176337|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN
176338|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN
176339|NCT01459653|O3|Outcome|EP2006: High (>20%) Risk|Cancer patients treated with chemotherapy with high risk(>20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176340|NCT01459653|O2|Outcome|EP2006: Medium (10-20%) Risk|Cancer patients treated with chemotherapy with medium risk(10-20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176500|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176341|NCT01459653|O1|Outcome|EP2006: Low (<10%) Risk|Cancer patients treated with chemotherapy with low risk(<10%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176342|NCT01459653|O1|Outcome|EP2006 Cycle Level|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176343|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176344|NCT01459653|O1|Outcome|EP2006 Cycles|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176345|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176346|NCT01459653|O3|Outcome|EP2006 - Hematological Tumor|Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176347|NCT01459653|O2|Outcome|EP2006 - Solid Tumor|Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176348|NCT01459653|O1|Outcome|EP2006 - All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176349|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176350|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176351|NCT01459653|O3|Outcome|EP2006: EP2006 Initiation Later (Day 4 or More)^|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation later (day 4 or more).
176352|NCT01459653|O2|Outcome|EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP 2006 initiation per guidelines (days 1-3).
176353|NCT01459653|O1|Outcome|EP2006: EP2006 Initiation During Chemotherapy (Day 0)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation during chemotherapy, day 0).
176354|NCT01459653|O3|Outcome|EP2006: Hematological Tumor|Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176355|NCT01459653|O2|Outcome|EP2006: Solid Tumor|Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176356|NCT01459653|O1|Outcome|EP2006: All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176357|NCT01459653|O3|Outcome|EP2006, <10% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (<10% chemo-associated FN risk).
176358|NCT01459653|O2|Outcome|EP2006, 10-20% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (10-20% chemo-associated FN risk).
176359|NCT01459653|O1|Outcome|EP2006, >20% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (>20% chemo-associated FN risk)
176360|NCT01459653|O3|Outcome|EP2006 - Hematological Tumor|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Hematological tumor).
176361|NCT01459653|O2|Outcome|EP2006 - Solid Tumor|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Solid tumor).
176362|NCT01459653|O1|Outcome|EP2006 - All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (all patients).
176363|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176364|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176365|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176366|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176367|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176368|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176369|NCT01459653|O3|Outcome|EP2006: >20% Risk|Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176370|NCT01459653|O2|Outcome|EP2006: 10-20% Risk|Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176371|NCT01459653|O1|Outcome|EP2006: <10% Risk|Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176496|NCT01458951|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176372|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
176373|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
176374|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176375|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176376|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176377|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176378|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176379|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176380|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176381|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176382|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176383|NCT01459653|O3|Outcome|EP2006: >20% Risk|Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176384|NCT01459653|O2|Outcome|EP2006: 10-20% Risk|Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176385|NCT01459653|O1|Outcome|EP2006: <10% Risk|Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176386|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy as and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
176387|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
176388|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176389|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176390|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176391|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176392|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176393|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176394|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176395|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176396|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176397|NCT01459653|O3|Outcome|EP2006: Risk >20%|Cancer patients with chemotherapy toxicity >20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176398|NCT01459653|O2|Outcome|EP2006: Risk 10-20%|Cancer patients with chemotherapy toxicity 10-20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176399|NCT01459653|O1|Outcome|EP2006: Risk <10%|Cancer patients with chemotherapy toxicity <10% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176400|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176401|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176402|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176403|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176404|NCT01459653|O2|Outcome|EP2006: >65kg|Cancer patients weighing >65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176405|NCT01459653|O1|Outcome|EP2006: <=65kg|Cancer patients weighing <=65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176406|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176407|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176408|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176409|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176410|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176411|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176412|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176413|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176414|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176415|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176416|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176417|NCT01459653|O2|Outcome|EP2006: >=65 Years|Cancer patients >=65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176418|NCT01459653|O1|Outcome|EP2006: <65 Years|Cancer patients <65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176419|NCT01459653|O2|Outcome|EP2006: Female|Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176420|NCT01459653|O1|Outcome|EP2006: Male|Male cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176421|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176422|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176423|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176424|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176425|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
176426|NCT01459653|E1|Reported Event|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Number 1496 refers to the total number of patients who received at least one dose of study medication EP2006.
176427|NCT01459588|B5|Baseline|Total|Total of all reporting groups
176428|NCT01459588|B4|Baseline|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176429|NCT01459588|B3|Baseline|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176430|NCT01459588|B2|Baseline|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176431|NCT01459588|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176432|NCT01459588|P4|Participant Flow|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176433|NCT01459588|P3|Participant Flow|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176434|NCT01459588|P2|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176435|NCT01459588|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176436|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176497|NCT01458951|P3|Participant Flow|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176437|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176438|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176439|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176440|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176441|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176442|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176443|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176444|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176445|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176446|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176447|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176448|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176449|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176450|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176451|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176452|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176453|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176454|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176455|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176456|NCT01459588|E4|Reported Event|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176457|NCT01459588|E3|Reported Event|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176458|NCT01459588|E2|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
176459|NCT01459588|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
176460|NCT01459068|B3|Baseline|Total|Total of all reporting groups
176461|NCT01459068|B2|Baseline|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.
Common Elements Treatment Approach: CETA components include:
Engagement (encouraging participation)
Psychoeducation (introduction)
Anxiety Management Strategies (relaxation)
Behavioral Activation (getting active)
Cognitive Coping/Restructuring (thinking in a different way, part I and part II)
Imaginal Gradual Exposure (talking about difficult memories)
In Vivo Exposure (Live exposure)
Suicide/Homicide/Danger Assessment and Planning (safety)
Screening and Brief Intervention for Alcohol (alcohol intervention)"
176462|NCT01459068|B1|Baseline|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
176498|NCT01458951|P2|Participant Flow|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176463|NCT01459068|P2|Participant Flow|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.
Common Elements Treatment Approach: CETA components include:
Engagement (encouraging participation)
Psychoeducation (introduction)
Anxiety Management Strategies (relaxation)
Behavioral Activation (getting active)
Cognitive Coping/Restructuring (thinking in a different way, part I and part II)
Imaginal Gradual Exposure (talking about difficult memories)
In Vivo Exposure (Live exposure)
Suicide/Homicide/Danger Assessment and Planning (safety)
Screening and Brief Intervention for Alcohol (alcohol intervention)"
176464|NCT01459068|P1|Participant Flow|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
176465|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.
Common Elements Treatment Approach: CETA components include:
Engagement (encouraging participation)
Psychoeducation (introduction)
Anxiety Management Strategies (relaxation)
Behavioral Activation (getting active)
Cognitive Coping/Restructuring (thinking in a different way, part I and part II)
Imaginal Gradual Exposure (talking about difficult memories)
In Vivo Exposure (Live exposure)
Suicide/Homicide/Danger Assessment and Planning (safety)
Screening and Brief Intervention for Alcohol (alcohol intervention)"
176466|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
176467|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.
Common Elements Treatment Approach: CETA components include:
Engagement (encouraging participation)
Psychoeducation (introduction)
Anxiety Management Strategies (relaxation)
Behavioral Activation (getting active)
Cognitive Coping/Restructuring (thinking in a different way, part I and part II)
Imaginal Gradual Exposure (talking about difficult memories)
In Vivo Exposure (Live exposure)
Suicide/Homicide/Danger Assessment and Planning (safety)
Screening and Brief Intervention for Alcohol (alcohol intervention)"
176468|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
176469|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.
Common Elements Treatment Approach: CETA components include:
Engagement (encouraging participation)
Psychoeducation (introduction)
Anxiety Management Strategies (relaxation)
Behavioral Activation (getting active)
Cognitive Coping/Restructuring (thinking in a different way, part I and part II)
Imaginal Gradual Exposure (talking about difficult memories)
In Vivo Exposure (Live exposure)
Suicide/Homicide/Danger Assessment and Planning (safety)
Screening and Brief Intervention for Alcohol (alcohol intervention)"
176470|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
176471|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.
Common Elements Treatment Approach: CETA components include:
Engagement (encouraging participation)
Psychoeducation (introduction)
Anxiety Management Strategies (relaxation)
Behavioral Activation (getting active)
Cognitive Coping/Restructuring (thinking in a different way, part I and part II)
Imaginal Gradual Exposure (talking about difficult memories)
In Vivo Exposure (Live exposure)
Suicide/Homicide/Danger Assessment and Planning (safety)
Screening and Brief Intervention for Alcohol (alcohol intervention)"
176472|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
176473|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.
Common Elements Treatment Approach: CETA components include:
Engagement (encouraging participation)
Psychoeducation (introduction)
Anxiety Management Strategies (relaxation)
Behavioral Activation (getting active)
Cognitive Coping/Restructuring (thinking in a different way, part I and part II)
Imaginal Gradual Exposure (talking about difficult memories)
In Vivo Exposure (Live exposure)
Suicide/Homicide/Danger Assessment and Planning (safety)
Screening and Brief Intervention for Alcohol (alcohol intervention)"
176474|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
176475|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.
Common Elements Treatment Approach: CETA components include:
Engagement (encouraging participation)
Psychoeducation (introduction)
Anxiety Management Strategies (relaxation)
Behavioral Activation (getting active)
Cognitive Coping/Restructuring (thinking in a different way, part I and part II)
Imaginal Gradual Exposure (talking about difficult memories)
In Vivo Exposure (Live exposure)
Suicide/Homicide/Danger Assessment and Planning (safety)
Screening and Brief Intervention for Alcohol (alcohol intervention)"
176476|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
176477|NCT01459068|E2|Reported Event|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.
Common Elements Treatment Approach: CETA components include:
Engagement (encouraging participation)
Psychoeducation (introduction)
Anxiety Management Strategies (relaxation)
Behavioral Activation (getting active)
Cognitive Coping/Restructuring (thinking in a different way, part I and part II)
Imaginal Gradual Exposure (talking about difficult memories)
In Vivo Exposure (Live exposure)
Suicide/Homicide/Danger Assessment and Planning (safety)
Screening and Brief Intervention for Alcohol (alcohol intervention)"
176478|NCT01459068|E1|Reported Event|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
176479|NCT01459016|B1|Baseline|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176480|NCT01459016|P1|Participant Flow|Standard of Care|Participants with prodromal to mild Alzheimer’s Disease (AD) underwent a florbetapir F 18 positron emission tomography (PET) scan. (Single intravenous microdose of 260 to 370 megabecquerels (MBq) [7 to 10 millicuries (mCi)] of florbetapir.) Those who tested amyloid positive and met other entry criteria received standard of care for up to 12 months (mos). No therapeutic investigational drug intended to treat AD was administered.
176481|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176482|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176483|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176484|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176485|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176486|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176487|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176488|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176489|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176490|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176491|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176492|NCT01459016|E1|Reported Event|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
176493|NCT01458951|B4|Baseline|Total|Total of all reporting groups
176494|NCT01458951|B3|Baseline|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176495|NCT01458951|B2|Baseline|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176501|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176502|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176503|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176504|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176505|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176506|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176507|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176508|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176509|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176510|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176511|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176512|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176513|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176514|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176515|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176516|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176517|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176518|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176519|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176520|NCT01458951|E3|Reported Event|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
176521|NCT01458951|E2|Reported Event|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176522|NCT01458951|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
176523|NCT01458639|B1|Baseline|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
176524|NCT01458639|P1|Participant Flow|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
176525|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
176526|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
176527|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
176528|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
176529|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
176530|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
176531|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
176583|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176587|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176532|NCT01458639|E1|Reported Event|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
176533|NCT01458587|B3|Baseline|Total|Total of all reporting groups
176534|NCT01458587|B2|Baseline|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
176535|NCT01458587|B1|Baseline|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
176536|NCT01458587|P2|Participant Flow|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
176537|NCT01458587|P1|Participant Flow|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
176538|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176539|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176540|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176541|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176542|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176543|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176544|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176545|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176546|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176547|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176548|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176549|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176550|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176551|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176552|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176553|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176554|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176555|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176556|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176557|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176558|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176559|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176560|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176561|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176562|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176563|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176564|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176565|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176566|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176567|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176568|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176569|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176570|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176571|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176572|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176573|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176574|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176575|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176576|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176577|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176578|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176579|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176580|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176581|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
196724|NCT01385995|B1|Baseline|Continuous Positive Airway Pressure (CPAP)|
176588|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176589|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176590|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176591|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176592|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176593|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176594|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176595|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176596|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176597|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176598|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176599|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176600|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176601|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176602|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176603|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176604|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176605|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176606|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176607|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176608|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176609|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176610|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176611|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176612|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176613|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176614|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176615|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176616|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176617|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176618|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176619|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176620|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176621|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176622|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176623|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176624|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176625|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176626|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176627|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176628|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176629|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176630|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176631|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176632|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176633|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176634|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176635|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176636|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176637|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176638|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176639|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
196939|NCT01385189|O1|Outcome|10 μg Na-GST-1/Alhydrogel|
176640|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176641|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176642|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176643|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176644|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176645|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176646|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176647|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176648|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176649|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176650|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176651|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176652|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176653|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176654|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176655|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176656|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176657|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176658|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176659|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176660|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176661|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176662|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176663|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176664|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176665|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176666|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176667|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176668|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176669|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176670|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176671|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176672|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176673|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176674|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176675|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176676|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176677|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176678|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176679|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176680|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176681|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176682|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176683|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176684|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176685|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176686|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176687|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176688|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
176689|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176690|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
176691|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
176692|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
197500|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
176693|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
176694|NCT01458587|E2|Reported Event|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
176695|NCT01458587|E1|Reported Event|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
176696|NCT01458574|B4|Baseline|Total|Total of all reporting groups
176697|NCT01458574|B3|Baseline|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176698|NCT01458574|B2|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176699|NCT01458574|B1|Baseline|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176700|NCT01458574|P3|Participant Flow|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176701|NCT01458574|P2|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176702|NCT01458574|P1|Participant Flow|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176703|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176704|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176705|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176706|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176707|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176708|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176709|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176710|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176711|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176712|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176713|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176714|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176715|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176716|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176717|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176718|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176719|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176720|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176721|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176722|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176838|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
176914|NCT01458288|O1|Outcome|TG-0054 (3.14 mg/kg)|Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.
176723|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176724|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176725|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176726|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176727|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176728|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176729|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176730|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176731|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176732|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176733|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176734|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176735|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176736|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176737|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176738|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176739|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176740|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176741|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176742|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176743|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176744|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176745|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176746|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176747|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176748|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176749|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176750|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176751|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
177337|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
176752|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176753|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176754|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176755|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176756|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176757|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176758|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176759|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176760|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176761|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176762|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176763|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176764|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176765|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176766|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176767|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176768|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176769|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176770|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176771|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176772|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176773|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176774|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176775|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176776|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176777|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176778|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176779|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176780|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
177338|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
176781|NCT01458574|E3|Reported Event|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176782|NCT01458574|E2|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176783|NCT01458574|E1|Reported Event|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
176784|NCT01458561|B3|Baseline|Total|Total of all reporting groups
176785|NCT01458561|B2|Baseline|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176786|NCT01458561|B1|Baseline|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176787|NCT01458561|P2|Participant Flow|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176788|NCT01458561|P1|Participant Flow|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176789|NCT01458561|O2|Outcome|Complications/Adverse Events in Subj. Receiving Gelfoam Plus|"Number of complications/adverse events recorded for subjects receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176790|NCT01458561|O1|Outcome|Complications/Adverse Events in Subjects Receiving BioFoam|"Number of complications/adverse events recorded for subjects receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176791|NCT01458561|O2|Outcome|Anti-Bovine Serum Albumin (Anti-BSA) Titer in Gelfoam Plus Sub|"Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176792|NCT01458561|O1|Outcome|Anti-Bovine Serum Albumin (Anti-BSA) Titers in BioFoam Subj|"Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176793|NCT01458561|O2|Outcome|# of Gelfoam Plus Subj. Requiring Hospitalization/Intervention|"Number of subjects receiving Gelfoam Plus as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176794|NCT01458561|O1|Outcome|# of BioFoam Subjects Requiring Hospitalization/Intervention|"Number of subjects receiving BioFoam Surgical Matrix as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176795|NCT01458561|O2|Outcome|Length of Hospital Stay for Gelfoam Plus Subjects|"Length of hospital stay for subjects receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176796|NCT01458561|O1|Outcome|Length of Hospital Stay for BioFoam Surgical Matrix Subjects|"Length of hospital stay for subjects receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176797|NCT01458561|O2|Outcome|Core Body Temp of Gelfoam Plus During Hemostat Application|"Core body temp during prescribed topical hemostat application for subjects receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176798|NCT01458561|O1|Outcome|Core Body Temp of BioFoam Subjects During Hemostat Application|"Core body temp during prescribed topical hemostat application for subjects receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176799|NCT01458561|O2|Outcome|Total Time of Procedure for Gelfoam Plus Subjects|"Total time of procedure for subjects receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176800|NCT01458561|O1|Outcome|Total Time of Procedure for BioFoam Surgical Matrix Subjects|"Total time of procedure for subjects receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176801|NCT01458561|O2|Outcome|Gelfoam Plus Subj. Requiring Reop. Due to Bleeding/Bili. Leak|"Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176802|NCT01458561|O1|Outcome|BioFoam Subj. Requiring Reop. Due to Bleeding/Biliary Leakage|"Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176803|NCT01458561|O2|Outcome|Presence of Device Via MRI in Gelfoam Plus Subjects|"Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176804|NCT01458561|O1|Outcome|Presence of Device Via MRI in BioFoam Surgical Matrix Subjects|"Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176805|NCT01458561|O2|Outcome|Laboratory Evaluations for Gelfoam Plus Subjects Out of Range|"Number of out of range lab evaluations for subjects receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176806|NCT01458561|O1|Outcome|Laboratory Evaluations for BioFoam Subjects Out of Range|"Number of out of range lab evaluations for subjects receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176807|NCT01458561|O2|Outcome|Amt. of Intraop. Blood Products Rec'd by Gelfoam Plus Subjects|"Amount of blood products administered intraoperatively to subjects receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
201039|NCT01369745|E3|Reported Event|Prednisone|Prednisone 5 mg once daily
176808|NCT01458561|O1|Outcome|Amt. of Intraop. Blood Products Rec'd by BioFoam Subjects|"Amount of blood products administered intraoperatively to subjects receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176809|NCT01458561|O2|Outcome|Duration of Postoperative Drainage in Gelfoam Plus Subjects|"Duration of postoperative drainage in subjects receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176810|NCT01458561|O1|Outcome|Duration of Postoperative Drainage in BioFoam Subjects|"Duration of postoperative drainage in subjects receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176811|NCT01458561|O2|Outcome|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176812|NCT01458561|O1|Outcome|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176813|NCT01458561|O2|Outcome|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176814|NCT01458561|O1|Outcome|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176815|NCT01458561|O2|Outcome|Intraop. Blood Loss in Gelfoam Plus Subjects|"Amount of blood lost intraoperatively in subjects receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176816|NCT01458561|O1|Outcome|Intraop. Blood Loss in BioFoam Surgical Matrix Subjects|"Amount of blood lost intraoperatively in subjects receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176817|NCT01458561|O2|Outcome|Achievement of Immediate Hemostasis in Gelfoam Plus Subjects|"Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176818|NCT01458561|O1|Outcome|Achieve Immediate Hemostasis in BioFoam Subjects/Participants|"Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176819|NCT01458561|O2|Outcome|Subjects/Participants Receiving Gelfoam Plus|"Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176820|NCT01458561|O1|Outcome|Subjects/Participants Receiving BioFoam|"Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176821|NCT01458561|O2|Outcome|Control Bleeding in Gelfoam Plus Subjects/Participants|"Control of bleeding in subjects/participants who receive Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176822|NCT01458561|O1|Outcome|Control Bleeding in BioFoam Subjects/Participants|"Control of bleeding in subjects/participants who receive BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176823|NCT01458561|E2|Reported Event|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
176824|NCT01458561|E1|Reported Event|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct
BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
176825|NCT01458535|B7|Baseline|Total|Total of all reporting groups
176826|NCT01458535|B6|Baseline|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
176827|NCT01458535|B5|Baseline|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
176828|NCT01458535|B4|Baseline|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
176829|NCT01458535|B3|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
176830|NCT01458535|B2|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
176831|NCT01458535|B1|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
176832|NCT01458535|P6|Participant Flow|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
176833|NCT01458535|P5|Participant Flow|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
176834|NCT01458535|P4|Participant Flow|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
176835|NCT01458535|P3|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
176836|NCT01458535|P2|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
176837|NCT01458535|P1|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve genotype 1 participants.
205746|NCT01353976|B2|Baseline|Vehicle Foam|Placebo medication
176839|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
176840|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
176841|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
176842|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
176843|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
176844|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
176845|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
176846|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
176847|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
176848|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
176849|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
176850|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
176851|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
176852|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
176853|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
176854|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
176855|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
176856|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
176857|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
176858|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
176859|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
176860|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
176861|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
176862|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
176863|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
176864|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
176865|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
176866|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
176867|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
176868|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
176869|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
176870|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
176871|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
177764|NCT01456052|E1|Reported Event|Placebo|Placebo: Matching placebo administered orally
176872|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
176873|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
176874|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
176875|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
176876|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
176877|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
176878|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
176879|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
176880|NCT01458535|E6|Reported Event|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.
176881|NCT01458535|E5|Reported Event|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.
176882|NCT01458535|E4|Reported Event|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.
176883|NCT01458535|E3|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.
176884|NCT01458535|E2|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.
176885|NCT01458535|E1|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.
176886|NCT01458392|B4|Baseline|Total|Total of all reporting groups
176887|NCT01458392|B3|Baseline|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
176888|NCT01458392|B2|Baseline|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
176889|NCT01458392|B1|Baseline|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
176890|NCT01458392|P3|Participant Flow|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
176891|NCT01458392|P2|Participant Flow|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
176892|NCT01458392|P1|Participant Flow|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
176893|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
176894|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
176895|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
176896|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
176897|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
176898|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
176899|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
176900|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
176901|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
176902|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
176903|NCT01458392|O3|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
176904|NCT01458392|O2|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
176905|NCT01458392|O1|Outcome|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
176906|NCT01458392|O2|Outcome|Dalantercept 1.2 mg/kg|Subcutaneous 1.2-mg/kg dose of dalantercept once every 3 weeks.
176907|NCT01458392|O1|Outcome|Dalantercept 0.6 mg/kg|Subcutaneous 0.6-mg/kg dose of dalantercept once every 3 weeks.
176908|NCT01458392|E3|Reported Event|Dalantercept 1.2 mg/kg|Subcutaneous 1.2 mg/kg dose of dalantercept once every 3 weeks.
176909|NCT01458392|E2|Reported Event|Dalantercept 0.6 mg/kg|Subcutaneous 0.6 mg/kg dose of dalantercept once every 3 weeks.
176910|NCT01458392|E1|Reported Event|Dalantercept 80 mg|Subcutaneous 80 mg dose of dalantercept once every 3 weeks.
176911|NCT01458288|B1|Baseline|TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)|"TG-0054 (3.14 mg/kg)
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
176912|NCT01458288|P1|Participant Flow|TG-0054 (3.14 mg/kg TG-0054 Administrated Via 15-min IV Infus)|"TG-0054 (3.14 mg/kg)
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
176913|NCT01458288|O2|Outcome|TG-0054 (3.14 mg/kg)+G-CSF|Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
176915|NCT01458288|E1|Reported Event|TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)|"TG-0054 (3.14 mg/kg)
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
176916|NCT01458275|B4|Baseline|Total|Total of all reporting groups
176917|NCT01458275|B3|Baseline|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176918|NCT01458275|B2|Baseline|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176919|NCT01458275|B1|Baseline|Placebo|Placebo: Placebo - one actuation per nostril
176920|NCT01458275|P3|Participant Flow|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176921|NCT01458275|P2|Participant Flow|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176922|NCT01458275|P1|Participant Flow|Placebo|Placebo: Placebo - one actuation per nostril
176923|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176924|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176925|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
176926|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176927|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176928|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
176929|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176930|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176931|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
176932|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176933|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176934|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
176935|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176936|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176937|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
176938|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176939|NCT01458275|O1|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176940|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176941|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176942|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
176943|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176944|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176945|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
176946|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176947|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176948|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
176949|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176950|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176951|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
176952|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176953|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176954|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
176955|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
176956|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176957|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
176958|NCT01458275|E3|Reported Event|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
177765|NCT01456039|B4|Baseline|Total|Total of all reporting groups
176959|NCT01458275|E2|Reported Event|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
176960|NCT01458275|E1|Reported Event|Placebo|Placebo: Placebo - one actuation per nostril
176961|NCT01458249|B3|Baseline|Total|Total of all reporting groups
176962|NCT01458249|B2|Baseline|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
176963|NCT01458249|B1|Baseline|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
176964|NCT01458249|P1|Participant Flow|All Treated Participants (Arm 1 and Arm 2)|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks).
176965|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
176966|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
176967|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
176968|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
176969|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
176970|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
176971|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
176972|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
176973|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
176974|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
176975|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
176976|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
176977|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
176978|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
176979|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
176980|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
176981|NCT01458249|E1|Reported Event|All Treated Participants (Arm 1 and Arm 2)|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks).
176982|NCT01458210|B1|Baseline|Overall Study|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).
Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
177339|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
205747|NCT01353976|B1|Baseline|Econazole Nitrate Foam 1%|Study medication
177341|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
176983|NCT01458210|P1|Participant Flow|Overall Study|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).
Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
176984|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.
Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
176985|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
176986|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.
Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
176987|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
176988|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.
Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
176989|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
176990|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.
Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
176991|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
176992|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.
Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
176993|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
177149|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
176994|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.
Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
176995|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
176996|NCT01458210|E3|Reported Event|Ortho-Cyclen + Dulaglutide|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).
Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
176997|NCT01458210|E2|Reported Event|Ortho-Cyclen Alone|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).
176998|NCT01458210|E1|Reported Event|Lead-in (1st Course of Ortho-Cyclen)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in).
176999|NCT01458171|B1|Baseline|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
177000|NCT01458171|P1|Participant Flow|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
177001|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
177002|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
177003|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
177004|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
177005|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
177006|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
177007|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
177008|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
177009|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
177010|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
177011|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
177012|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
177013|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
177014|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
177015|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
177016|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
177017|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
205748|NCT01353976|P2|Participant Flow|Vehicle Foam|Placebo medication
177018|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
177019|NCT01458171|E1|Reported Event|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
177020|NCT01458106|B3|Baseline|Total|Total of all reporting groups
177021|NCT01458106|B2|Baseline|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177022|NCT01458106|B1|Baseline|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177023|NCT01458106|P2|Participant Flow|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177024|NCT01458106|P1|Participant Flow|Participants < 6 Years Old|"Pharmacokinetic (PK) subgroup: After a Washout Period of ≥72 hrs, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5±2 minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for PK assessment. Following a second Washout Period of ≥72 hrs, participants receive a single IV injection of rFVIIIFc over 5±2 mins at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177025|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177026|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177027|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177150|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
207016|NCT01349829|P1|Participant Flow|HAVpur|
177028|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177029|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177030|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177031|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177032|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177033|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177034|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177035|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177036|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177037|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
207017|NCT01349829|O2|Outcome|Havrix|
177038|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177039|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177040|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177041|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177042|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177043|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177044|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177045|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177046|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177047|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
207018|NCT01349829|O1|Outcome|HAVpur|
177048|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177049|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177050|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177051|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177052|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177053|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177054|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177055|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177056|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177057|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
207019|NCT01349829|O2|Outcome|Havrix|
177058|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177059|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177060|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177061|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177062|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177063|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177064|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177065|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177066|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177067|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
207020|NCT01349829|O1|Outcome|HAVpur|
177068|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177069|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177070|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177071|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177072|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177073|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177074|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177075|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177076|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
177102|NCT01457950|P3|Participant Flow|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177320|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
207021|NCT01349829|O2|Outcome|Havrix|
177077|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177078|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177079|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177080|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177081|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177082|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177083|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177103|NCT01457950|P2|Participant Flow|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177321|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177084|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177085|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177086|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177087|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177088|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177089|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177090|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177104|NCT01457950|P1|Participant Flow|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177322|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177091|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177092|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177093|NCT01458106|O3|Outcome|All Arms: Total|
177094|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177095|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177096|NCT01458106|E2|Reported Event|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥ 72 hours, at the Baseline Visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (± 2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥ 72 hours, participants receive a single IV injection of rFVIIIFc over 5 (± 2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177097|NCT01458106|E1|Reported Event|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥ 72 hours, at the Baseline Visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (± 2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥ 72 hours, participants receive a single IV injection of rFVIIIFc over 5 (± 2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
177098|NCT01457950|B3|Baseline|Total|Total of all reporting groups
177099|NCT01457950|B2|Baseline|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177100|NCT01457950|B1|Baseline|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177101|NCT01457950|P4|Participant Flow|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177340|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177105|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177106|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177107|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177108|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177109|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177110|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177111|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177112|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177113|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177114|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177115|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177116|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177117|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177118|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177119|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177120|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177121|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177122|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177123|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177124|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177125|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177126|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177127|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177128|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177129|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177148|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177323|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
207022|NCT01349829|O1|Outcome|HAVpur|
177130|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177131|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177132|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177133|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177134|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177135|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177136|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177137|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177138|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177139|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177140|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177141|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177142|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177143|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177144|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177145|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177146|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177147|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
207023|NCT01349829|O2|Outcome|Havrix|
177151|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177152|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177153|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177154|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177155|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177156|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177157|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177158|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177159|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177160|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177161|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177162|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177163|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177164|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177165|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177166|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177167|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177168|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177169|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177170|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177171|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177172|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177173|NCT01457950|E4|Reported Event|Open Label Denosumab 60 mg (Previously Randomized Placebo)|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177324|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177174|NCT01457950|E3|Reported Event|Open Label Denosumab 60 mg (Previously Randomized Denosumab)|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
177175|NCT01457950|E2|Reported Event|Randomized Phase: Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
177176|NCT01457950|E1|Reported Event|Randomized Phase: Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
177177|NCT01457885|B1|Baseline|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
177178|NCT01457885|P1|Participant Flow|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
177179|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
177180|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
177181|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
177182|NCT01457885|E1|Reported Event|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
177183|NCT01457846|B3|Baseline|Total|Total of all reporting groups
177184|NCT01457846|B2|Baseline|AZD4547|80mg BD 2 weeks on/1 week off
177185|NCT01457846|B1|Baseline|Paclitaxel|80mg / m^2
177186|NCT01457846|P2|Participant Flow|Paclitaxel|80mg / m^2
177187|NCT01457846|P1|Participant Flow|AZD4547|80mg BD 2 weeks on/1 week off
177188|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
177189|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
177190|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
177191|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
177192|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
177193|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
177194|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
177195|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
177196|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
177197|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
177198|NCT01457846|E2|Reported Event|Paclitaxel|80mg / m^2
177199|NCT01457846|E1|Reported Event|AZD4547|80mg BD 2 weeks on/1 week off
177200|NCT01457703|B3|Baseline|Total|Total of all reporting groups
177201|NCT01457703|B2|Baseline|BMI 18-25 kg/m2|"BMI 18-25 kg/m2
History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
177202|NCT01457703|B1|Baseline|BMI ≥30 kg/m2|"BMI ≥30 kg/m2
History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
177203|NCT01457703|P2|Participant Flow|BMI 18-25 kg/m2|"BMI 18-25 kg/m2
History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
177204|NCT01457703|P1|Participant Flow|BMI ≥30 kg/m2|"BMI ≥30 kg/m2
History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
177205|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2
History of regular menstrual cycles every 25-35 days
GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
177206|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2
History of regular menstrual cycles every 25-40 days
GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
177207|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2
History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
177208|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2
History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
177209|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2
History of regular menstrual cycles every 25-35 days
GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
177210|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2
History of regular menstrual cycles every 25-40 days
GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
177325|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177211|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2
History of regular menstrual cycles every 25-35 days
GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
177212|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2
History of regular menstrual cycles every 25-40 days
GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
177213|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2
History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
177214|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2
History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
177215|NCT01457703|E2|Reported Event|BMI 18-25 kg/m2|"BMI 18-25 kg/m2
History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
177216|NCT01457703|E1|Reported Event|BMI ≥30 kg/m2|"BMI ≥30 kg/m2
History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
177217|NCT01457521|B3|Baseline|Total|Total of all reporting groups
177218|NCT01457521|B2|Baseline|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
177219|NCT01457521|B1|Baseline|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
177220|NCT01457521|P2|Participant Flow|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
177221|NCT01457521|P1|Participant Flow|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
177222|NCT01457521|O2|Outcome|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
177223|NCT01457521|O1|Outcome|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
177224|NCT01457521|E2|Reported Event|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
177225|NCT01457521|E1|Reported Event|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
177226|NCT01457430|B1|Baseline|Icatibant|Icatibant: 30 mg subcutaneous dose of Icatibant
177227|NCT01457430|P1|Participant Flow|Icatibant|Icatibant: 30 mg subcutaneous dose of Icatibant
177228|NCT01457430|O2|Outcome|Icatibant Treatment by Self Administration|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
177229|NCT01457430|O1|Outcome|Icatibant Treatment With Health Care Provider|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.
177230|NCT01457430|O2|Outcome|Icatibant Treatment by Self Administration|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
177231|NCT01457430|O1|Outcome|Icatibant Treatment With Health Care Provider|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.
177232|NCT01457430|E1|Reported Event|Icatibant|"Open-label study
Icatibant: 30 mg subcutaneous dose of Icatibant"
177233|NCT01457417|B6|Baseline|Total|Total of all reporting groups
177234|NCT01457417|B5|Baseline|300 mg DKN-01 Part B|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177235|NCT01457417|B4|Baseline|600 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177236|NCT01457417|B3|Baseline|300 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177237|NCT01457417|B2|Baseline|150 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
207024|NCT01349829|O1|Outcome|HAVpur|
177238|NCT01457417|B1|Baseline|75 Milligram (mg) DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177239|NCT01457417|P5|Participant Flow|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177240|NCT01457417|P4|Participant Flow|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177241|NCT01457417|P3|Participant Flow|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177242|NCT01457417|P2|Participant Flow|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
177243|NCT01457417|P1|Participant Flow|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177244|NCT01457417|O1|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177245|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177246|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177247|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177248|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
177326|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
207025|NCT01349829|O2|Outcome|Havrix|
177249|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177250|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177251|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177252|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177253|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
177254|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177255|NCT01457417|O1|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177256|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177257|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177258|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177259|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
177327|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
207026|NCT01349829|O1|Outcome|HAVpur|
177260|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177261|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177262|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177263|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177264|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
177265|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177266|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177267|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177268|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177269|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
177328|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177329|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177330|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177906|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177270|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177271|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177272|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177273|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177274|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
177275|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177276|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177277|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177278|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177279|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
177331|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177332|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177333|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
207027|NCT01349829|O2|Outcome|Havrix|
177280|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177281|NCT01457417|O6|Outcome|Total|Total across all treatment groups
177282|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177283|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177284|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177285|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
177286|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177287|NCT01457417|O6|Outcome|Total|Total across all treatment groups
177288|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177289|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177290|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177291|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
177334|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177335|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177292|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177293|NCT01457417|E5|Reported Event|300 mg DKN-01 Part B|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
177294|NCT01457417|E4|Reported Event|600 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177295|NCT01457417|E3|Reported Event|300 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177296|NCT01457417|E2|Reported Event|150 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
177297|NCT01457417|E1|Reported Event|75 Milligram (mg) DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
177298|NCT01457339|B3|Baseline|Total|Total of all reporting groups
177299|NCT01457339|B2|Baseline|SPD489 (Lisdexamfetamine Dimesylate)(All Doses)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
177300|NCT01457339|B1|Baseline|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
177301|NCT01457339|P2|Participant Flow|SPD489 (Lisdexamfetamine Dimesylate)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
177302|NCT01457339|P1|Participant Flow|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
177303|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177304|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177305|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177306|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177307|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177308|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177309|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177310|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177311|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177312|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177313|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177314|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177315|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177316|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177317|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177318|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177319|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
207028|NCT01349829|O1|Outcome|HAVpur|
177342|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177343|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177344|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177345|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177346|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177347|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177348|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177349|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177350|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177351|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177352|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177353|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177354|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177355|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177356|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177357|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177358|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177359|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177360|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177361|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177362|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177363|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177364|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177365|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177366|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177367|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177368|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177369|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177370|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177371|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177372|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177373|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177374|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177375|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177376|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177377|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177378|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177379|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177380|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177381|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177382|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177383|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177384|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177385|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177386|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177387|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177388|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177389|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177390|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177391|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177392|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177393|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177394|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177395|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177396|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
207029|NCT01349829|E4|Reported Event|Havrix - Second Vaccination|
177397|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177398|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177399|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177400|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177401|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177402|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177403|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177404|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177405|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177406|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177407|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177408|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177409|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177410|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177411|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177412|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177413|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177414|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177415|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177416|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177417|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177418|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177419|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177420|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177421|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177422|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177423|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177424|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177425|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177426|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177427|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177428|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177429|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177430|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177431|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177432|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177433|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177434|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177435|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177436|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177437|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177438|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177439|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177440|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177441|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177442|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177443|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177444|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177445|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177446|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177447|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
177448|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
177449|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
177450|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177451|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177452|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177453|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
177454|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177455|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
177456|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177457|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
177458|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
177459|NCT01457339|E8|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(All Doses)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
177460|NCT01457339|E7|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
177461|NCT01457339|E6|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
177462|NCT01457339|E5|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
177463|NCT01457339|E4|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
177464|NCT01457339|E3|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
177465|NCT01457339|E2|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
177466|NCT01457339|E1|Reported Event|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
177467|NCT01457053|B1|Baseline|All Study Participants|2 subjects completed the study. 2 subjects did not complete either arm and did not have usable data.
177468|NCT01457053|P2|Participant Flow|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.
Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.
Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.
Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
177469|NCT01457053|P1|Participant Flow|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.
Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.
Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
177470|NCT01457053|O2|Outcome|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.
Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.
Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.
Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
177471|NCT01457053|O1|Outcome|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.
Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.
Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
177496|NCT01456962|P1|Participant Flow|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
177497|NCT01456962|O2|Outcome|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ)
177498|NCT01456962|O1|Outcome|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL)
177499|NCT01456962|E2|Reported Event|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ)
207030|NCT01349829|E3|Reported Event|HAVPur - Second Vaccination|
178283|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
177472|NCT01457053|E2|Reported Event|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.
Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.
Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.
Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
177473|NCT01457053|E1|Reported Event|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.
Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.
Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
177474|NCT01457014|B1|Baseline|Total Group|34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
177475|NCT01457014|P4|Participant Flow|Servo Ventilation Manual (Manual SV)|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.
servo ventilation manual: servo ventilation titrated in manual mode"
177476|NCT01457014|P3|Participant Flow|Servo Ventilation Auto Mode (autoSV)|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode"
177477|NCT01457014|P2|Participant Flow|Continuous Positive Airway Pressure (CPAP)|"Airway pressure delivered at a constant pressure level.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode"
177478|NCT01457014|P1|Participant Flow|Diagnostic Polysomnography (PSG)|A Diagnostic PSG was performed using the core equipment available to determine eligibility into the overnight portion of the study.
177479|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.
servo ventilation manual: servo ventilation titrated in manual mode"
177480|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode"
177481|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode"
177482|NCT01457014|O1|Outcome|Diagnostic PSG|Baseline overnight PSG.
177483|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.
servo ventilation manual: servo ventilation titrated in manual mode"
177484|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode"
177485|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode"
177486|NCT01457014|O1|Outcome|Diagnostic PSG|Baseline overnight PSG.
177487|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.
servo ventilation manual: servo ventilation titrated in manual mode"
177488|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode"
177489|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode"
177490|NCT01457014|O1|Outcome|Diagnostic Polysomnography (PSG)|Baseline overnight Polysomnography (PSG)
177491|NCT01457014|E1|Reported Event|Total Group|34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
177492|NCT01456962|B3|Baseline|Total|Total of all reporting groups
177493|NCT01456962|B2|Baseline|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
177494|NCT01456962|B1|Baseline|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
177495|NCT01456962|P2|Participant Flow|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
177500|NCT01456962|E1|Reported Event|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL)
177501|NCT01456936|B5|Baseline|Total|Total of all reporting groups
177502|NCT01456936|B4|Baseline|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177503|NCT01456936|B3|Baseline|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177504|NCT01456936|B2|Baseline|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177505|NCT01456936|B1|Baseline|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177506|NCT01456936|P4|Participant Flow|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177507|NCT01456936|P3|Participant Flow|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177508|NCT01456936|P2|Participant Flow|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177509|NCT01456936|P1|Participant Flow|Varenicline|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg daily once (QD) x 3 days, 0.5 mg twice daily (BID) x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177510|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177511|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177512|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177513|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177514|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177515|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177516|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177517|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177930|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177518|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177519|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177520|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177521|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177522|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177523|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177524|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177525|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177526|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177527|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177528|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177529|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177530|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177531|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177532|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177533|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177534|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177645|NCT01456299|O1|Outcome|Control|"The control group, which received an infusion of normal saline
remifentanil 1: The patients received an infusion of remifentanil"
177535|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177536|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177537|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177538|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177539|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177540|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177541|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177542|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177543|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177544|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177545|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177546|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177547|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177548|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177549|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177550|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177616|NCT01456780|B2|Baseline|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
207031|NCT01349829|E2|Reported Event|Havrix - First Vaccination|
177551|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177552|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177553|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177554|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177555|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177556|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177557|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177558|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177559|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177560|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177561|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177562|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177563|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177564|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177565|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177566|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177617|NCT01456780|B1|Baseline|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
177567|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177568|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177569|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177570|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177571|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177572|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177573|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177574|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177575|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177576|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177577|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177578|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177579|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177580|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177581|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177582|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177618|NCT01456780|P3|Participant Flow|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
178278|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
177583|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177584|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177585|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177586|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177587|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177588|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177589|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177590|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177591|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177592|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177593|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177594|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177595|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177596|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177597|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177598|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177619|NCT01456780|P2|Participant Flow|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
207032|NCT01349829|E1|Reported Event|HAVpur - First Vaccination|
177599|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177600|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177601|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177602|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177603|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177604|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177605|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177606|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177607|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177608|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177609|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177610|NCT01456936|E4|Reported Event|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
177611|NCT01456936|E3|Reported Event|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
177612|NCT01456936|E2|Reported Event|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
177613|NCT01456936|E1|Reported Event|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
177614|NCT01456780|B4|Baseline|Total|Total of all reporting groups
177615|NCT01456780|B3|Baseline|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
177644|NCT01456299|O2|Outcome|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml
control: Patients received a normal saline only"
177620|NCT01456780|P1|Participant Flow|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
177621|NCT01456780|O3|Outcome|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
177622|NCT01456780|O2|Outcome|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
177623|NCT01456780|O1|Outcome|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
177624|NCT01456780|O3|Outcome|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
177625|NCT01456780|O2|Outcome|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
177626|NCT01456780|O1|Outcome|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
177627|NCT01456780|O3|Outcome|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
177628|NCT01456780|O2|Outcome|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
177629|NCT01456780|O1|Outcome|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
177630|NCT01456780|O3|Outcome|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
177631|NCT01456780|O2|Outcome|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
177632|NCT01456780|O1|Outcome|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
177633|NCT01456780|E3|Reported Event|Bausch & Lomb Lubricant Drops|"Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks.
Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks."
177634|NCT01456780|E2|Reported Event|Lotemax|"Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling).
Loteprednol: Eye drops, 1 drop twice a day for 4 weeks"
177635|NCT01456780|E1|Reported Event|Zylet|"Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling). Tobramycin is an antibiotic.
Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks."
177636|NCT01456299|B4|Baseline|Total|Total of all reporting groups
177637|NCT01456299|B3|Baseline|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml
remifentanil 2: Patients received no remifentanil"
177638|NCT01456299|B2|Baseline|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml
control: Patients received a normal saline only"
177639|NCT01456299|B1|Baseline|Control|"The control group, which received an infusion of normal saline
remifentanil 1: The patients received an infusion of remifentanil"
177640|NCT01456299|P3|Participant Flow|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml
remifentanil 2: Patients received no remifentanil"
177641|NCT01456299|P2|Participant Flow|Control|"The control group, which received an infusion of normal saline
remifentanil 1: The patients received an infusion of remifentanil"
177642|NCT01456299|P1|Participant Flow|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml
control: Patients received a normal saline only"
177643|NCT01456299|O3|Outcome|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml
remifentanil 2: Patients received no remifentanil"
207371|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
177646|NCT01456299|E3|Reported Event|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml
remifentanil 2: Patients received no remifentanil"
177647|NCT01456299|E2|Reported Event|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml
control: Patients received a normal saline only"
177648|NCT01456299|E1|Reported Event|Control|"The control group, which received an infusion of normal saline
remifentanil 1: The patients received an infusion of remifentanil"
177649|NCT01456195|B4|Baseline|Total|Total of all reporting groups
177650|NCT01456195|B3|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
177651|NCT01456195|B2|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
177652|NCT01456195|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
177653|NCT01456195|P3|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
177654|NCT01456195|P2|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
177655|NCT01456195|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
177656|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
177657|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
177658|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
177659|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
177660|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
177661|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
177662|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
177663|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
177664|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
177665|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
177666|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
177667|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
177668|NCT01456195|E3|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
177669|NCT01456195|E2|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
177670|NCT01456195|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
177671|NCT01456169|B4|Baseline|Total|Total of all reporting groups
177672|NCT01456169|B3|Baseline|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177673|NCT01456169|B2|Baseline|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177674|NCT01456169|B1|Baseline|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177675|NCT01456169|P3|Participant Flow|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177676|NCT01456169|P2|Participant Flow|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177677|NCT01456169|P1|Participant Flow|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177678|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177679|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177680|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177681|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177682|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177683|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177684|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177685|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177686|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177687|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177688|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177689|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177690|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177691|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
207372|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
177692|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177693|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177694|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177695|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177696|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177697|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177698|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177699|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177700|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177701|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177702|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177703|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177704|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177705|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177706|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177707|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177708|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177709|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177710|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177711|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177712|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177713|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177714|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177715|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177716|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177717|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177718|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177719|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177720|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
177721|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
177722|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
177723|NCT01456169|E4|Reported Event|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
177724|NCT01456169|E3|Reported Event|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
177725|NCT01456169|E2|Reported Event|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
177726|NCT01456169|E1|Reported Event|Monotherapy: Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for 4 weeks during the Single-Blind Monotherapy Treatment Period. All enrolled participants, including those who were not randomized to double-blind treatment are included in this group.
177727|NCT01456143|B1|Baseline|HRME With Proflavine Hemisulfate|High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent
177762|NCT01456052|E3|Reported Event|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
177763|NCT01456052|E2|Reported Event|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
177728|NCT01456143|P1|Participant Flow|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
177729|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
177730|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
177731|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
177732|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
177733|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
177734|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
177735|NCT01456143|E1|Reported Event|HRME With Proflavine Hemisulfate|High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent
177736|NCT01456130|B1|Baseline|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
177737|NCT01456130|P1|Participant Flow|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
177738|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
177739|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
177740|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
177741|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
177742|NCT01456130|E1|Reported Event|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
177743|NCT01456052|B4|Baseline|Total|Total of all reporting groups
177744|NCT01456052|B3|Baseline|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
177745|NCT01456052|B2|Baseline|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
177746|NCT01456052|B1|Baseline|Placebo|Placebo: Matching placebo administered orally
177747|NCT01456052|P3|Participant Flow|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
177748|NCT01456052|P2|Participant Flow|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
177749|NCT01456052|P1|Participant Flow|Placebo|Placebo: Matching placebo administered orally
177750|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
177751|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
177752|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
177753|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
177754|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
177755|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
177756|NCT01456052|O3|Outcome|Placebo|Placebo: Matching placebo administered orally
177757|NCT01456052|O2|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
177758|NCT01456052|O1|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
177759|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
177760|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
177761|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
177766|NCT01456039|B3|Baseline|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177767|NCT01456039|B2|Baseline|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177768|NCT01456039|B1|Baseline|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177769|NCT01456039|P3|Participant Flow|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177770|NCT01456039|P2|Participant Flow|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177771|NCT01456039|P1|Participant Flow|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177772|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177773|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177774|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177775|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177776|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177777|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177778|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177779|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177780|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177781|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177782|NCT01456039|O1|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177783|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177784|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177785|NCT01456039|O1|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177786|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177787|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177788|NCT01456039|O1|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177789|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177790|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177791|NCT01456039|O1|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177792|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177793|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177794|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177795|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177796|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177797|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177798|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177799|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177800|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177801|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177802|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177803|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177804|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177805|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177806|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177807|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177808|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177809|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177810|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
178279|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
177811|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177812|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177813|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177814|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177815|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177816|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177817|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177818|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177819|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177820|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177821|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177822|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177823|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177824|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177825|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177826|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177827|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177828|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177829|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177830|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177831|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177832|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177833|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177834|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177835|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177836|NCT01456039|E4|Reported Event|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177837|NCT01456039|E3|Reported Event|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177838|NCT01456039|E2|Reported Event|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
177839|NCT01456039|E1|Reported Event|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
177840|NCT01456000|B3|Baseline|Total|Total of all reporting groups
177841|NCT01456000|B2|Baseline|Control Arm Ablation|"Treatment with standard ablation. Randomized and treated cohort.
Control Arm Ablation: Treatment with standard radiofrequency (RF) ablation."
177842|NCT01456000|B1|Baseline|EAS-AC (HeartLight)|"Treatment with the EAS-AC. Randomized and treated cohort.
EAS-AC (HeartLight): Pulmonary vien isolation"
177843|NCT01456000|P2|Participant Flow|Control Arm Ablation|"Treatment with standard ablation.
Control Arm Ablation: Treatment with standard ablation.
ITT Population 175 Participants"
177844|NCT01456000|P1|Participant Flow|EAS-AC (HeartLight)|"Treatment with the EAS-AC.
EAS-AC (HeartLight): Pulmonary vien isolation
ITT Population 178 participants"
177845|NCT01456000|O2|Outcome|Control Arm Ablation|"Treatment with standard ablation and evaluable for efficacy.
Control Arm Ablation: Treatment with standard ablation."
177846|NCT01456000|O1|Outcome|EAS-AC (HeartLight)|"Treatment with the EAS-AC and evaluable for efficacy.
EAS-AC (HeartLight): Pulmonary vien isolation"
177847|NCT01456000|E2|Reported Event|Control Arm Ablation|"Treatment with standard ablation.
Control Arm Ablation: Treatment with standard ablation.
ITT Population 175 Participants"
177848|NCT01456000|E1|Reported Event|EAS-AC (HeartLight)|"Treatment with the EAS-AC.
EAS-AC (HeartLight): Pulmonary vien isolation
ITT Population 178 participants"
177849|NCT01455545|B1|Baseline|Asthmatic Patients|"Patient group with bad control defined as participants with an Asthma Control Test (ACT) score = or < 19. Patient group with good control defined as participants with an Asthma Control Test (ACT)score > 19.
In both groups there were patients with mild, moderate and severe asthma according the Global Initiative for Asthma (GINA)."
177850|NCT01455545|P2|Participant Flow|Good Control|Patient group with good control defined as participants with an Asthma Control Test (ACT)> 19 points.
177851|NCT01455545|P1|Participant Flow|Bad Control|Patient group with bad control defined as participants with an Asthma Control Test (ACT) = or < 19 points.
177852|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
177853|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
178280|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
177854|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
177855|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
177856|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19 .
177857|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19 .
177858|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
177859|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
177860|NCT01455545|O2|Outcome|Good Control|Patients with asthma and goog control. Good control if ACT score > 19.
177861|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control. Bad control if ACT score < or = 19.
177862|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
177863|NCT01455545|O1|Outcome|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
177864|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
177865|NCT01455545|O1|Outcome|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19.
177866|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19 .
177867|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
177868|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19 .
177869|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
177870|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
177871|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
177872|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19.
177873|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19 .
177874|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19.
177875|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
177876|NCT01455545|E2|Reported Event|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control more than 19 score.
177877|NCT01455545|E1|Reported Event|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test. Good control less than 20 score.
177878|NCT01455519|B3|Baseline|Total|Total of all reporting groups
177879|NCT01455519|B2|Baseline|Hydromorphone ER|"Subjects received study drug: Hydromorphone ER
Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used."
177880|NCT01455519|B1|Baseline|Sugar Pill|Subjects may receive a pill with no medicine.
177881|NCT01455519|P2|Participant Flow|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177882|NCT01455519|P1|Participant Flow|Sugar Pill|Subjects may receive a pill with no medicine.
177883|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177884|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177885|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177886|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
178030|NCT01455194|B2|Baseline|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178031|NCT01455194|B1|Baseline|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
177887|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177888|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177889|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177890|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177891|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177892|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177893|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177894|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177895|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177896|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177897|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177898|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177899|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177900|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177901|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177902|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177903|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177904|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177905|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177907|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
177908|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
177909|NCT01455519|E2|Reported Event|Hydromorphone ER|"Subjects received study drug: Hydromorphone ER
Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used."
177910|NCT01455519|E1|Reported Event|Sugar Pill|Subjects may receive a pill with no medicine.
177911|NCT01455428|B3|Baseline|Total|Total of all reporting groups
177912|NCT01455428|B2|Baseline|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
177913|NCT01455428|B1|Baseline|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177914|NCT01455428|P2|Participant Flow|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
177915|NCT01455428|P1|Participant Flow|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177916|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177917|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177918|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177919|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177920|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177921|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177922|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177923|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177924|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177925|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177926|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177927|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177928|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177929|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177931|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177932|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177933|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177934|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177935|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177936|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177937|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177938|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177939|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177940|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177941|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177942|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177943|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177944|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177945|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177946|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177947|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177948|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177949|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177950|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177951|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177952|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
178032|NCT01455194|P4|Participant Flow|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178033|NCT01455194|P3|Participant Flow|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
177953|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177954|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177955|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177956|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177957|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177958|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177959|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177960|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177961|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177962|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177963|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177964|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
177965|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177966|NCT01455428|E2|Reported Event|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
177967|NCT01455428|E1|Reported Event|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
177968|NCT01455415|B3|Baseline|Total|Total of all reporting groups
177969|NCT01455415|B2|Baseline|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177970|NCT01455415|B1|Baseline|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177971|NCT01455415|P2|Participant Flow|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177972|NCT01455415|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177973|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178281|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
177974|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177975|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177976|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177977|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177978|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177979|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177980|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177981|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177982|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177983|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177984|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177985|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178034|NCT01455194|P2|Participant Flow|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period. Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178282|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
177986|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177987|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177988|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177989|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177990|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177991|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177992|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177993|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177994|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177995|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177996|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177997|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178035|NCT01455194|P1|Participant Flow|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period.
178036|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
177998|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
177999|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178000|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178001|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178002|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178003|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178004|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178005|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178006|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178007|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178008|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178009|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178037|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178038|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178010|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178011|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178012|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178013|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178014|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178015|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178016|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178017|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178018|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178019|NCT01455415|E2|Reported Event|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178020|NCT01455415|E1|Reported Event|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
178021|NCT01455220|B1|Baseline|Tysabri|All patients were receiving commercial Tysabri
178022|NCT01455220|P1|Participant Flow|All Patients|
178023|NCT01455220|O1|Outcome|MSQOL-54 Total (Baseline to 6 Months)|
178024|NCT01455220|O1|Outcome|FAMS (Baseline to 6 Months)|
178025|NCT01455220|O1|Outcome|MSQOL-54, Physical (Baseline to 6 Months)|
178026|NCT01455220|O1|Outcome|Baseline to 6 Months (MSISQ-19 Scores)|All enrolled participants
178027|NCT01455220|E1|Reported Event|All Patients|no Adverse events were experienced
178028|NCT01455194|B4|Baseline|Total|Total of all reporting groups
178029|NCT01455194|B3|Baseline|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178039|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178040|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178041|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178042|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178043|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178044|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178045|NCT01455194|O4|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178046|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178047|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178048|NCT01455194|O1|Outcome|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.
178049|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178050|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178051|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178052|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178053|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178054|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178055|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178056|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178057|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178058|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178059|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178060|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178061|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178062|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178063|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178064|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178065|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178066|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178067|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178068|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178069|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178070|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178071|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178072|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178073|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178074|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178075|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178076|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178077|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178078|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178079|NCT01455194|E4|Reported Event|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178080|NCT01455194|E3|Reported Event|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178081|NCT01455194|E2|Reported Event|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
178082|NCT01455194|E1|Reported Event|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.
178083|NCT01455181|B1|Baseline|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
178084|NCT01455181|P1|Participant Flow|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
178085|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
178086|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
178087|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
178088|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
178089|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
178090|NCT01455181|E1|Reported Event|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
178091|NCT01455064|B1|Baseline|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
178092|NCT01455064|P1|Participant Flow|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
178093|NCT01455064|O1|Outcome|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
178094|NCT01455064|E1|Reported Event|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
178095|NCT01455012|B3|Baseline|Total|Total of all reporting groups
178096|NCT01455012|B2|Baseline|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178097|NCT01455012|B1|Baseline|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178098|NCT01455012|P2|Participant Flow|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178099|NCT01455012|P1|Participant Flow|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178100|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178101|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178102|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178103|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178104|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178105|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178151|NCT01454947|O4|Outcome|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
178106|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178107|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178108|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178109|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178110|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178111|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178112|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178113|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178114|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178115|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178116|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178117|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178118|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178119|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178120|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178121|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178152|NCT01454947|O3|Outcome|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
207373|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
178122|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178123|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178124|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178125|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178126|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178127|NCT01455012|O1|Outcome|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178128|NCT01455012|E2|Reported Event|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)
Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178129|NCT01455012|E1|Reported Event|Placebo|"Placebo
Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
178130|NCT01454947|B9|Baseline|Total|Total of all reporting groups
178131|NCT01454947|B8|Baseline|SA, AJ, PC|Participants are given all 3 interventions.
178132|NCT01454947|B7|Baseline|AJ, PC|Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
178133|NCT01454947|B6|Baseline|SA, PC|Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
178134|NCT01454947|B5|Baseline|SA, AJ|Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
178135|NCT01454947|B4|Baseline|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
178136|NCT01454947|B3|Baseline|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
178137|NCT01454947|B2|Baseline|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
178138|NCT01454947|B1|Baseline|Education Control|Participants do not receive any of the 3 interventions.
178139|NCT01454947|P8|Participant Flow|SA, AJ, PC|Participants are given all 3 interventions.
178140|NCT01454947|P7|Participant Flow|AJ, PC|Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
178141|NCT01454947|P6|Participant Flow|SA, PC|Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
178142|NCT01454947|P5|Participant Flow|SA, AJ|Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
178143|NCT01454947|P4|Participant Flow|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
178144|NCT01454947|P3|Participant Flow|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
178145|NCT01454947|P2|Participant Flow|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
178146|NCT01454947|P1|Participant Flow|Education Control|Participants do not receive any of the 3 interventions.
178147|NCT01454947|O8|Outcome|SA+AJ+PC|Participants receive all three interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison interventions
178148|NCT01454947|O7|Outcome|Accountable Justification + Peer Comparison|Participants receive the Accountable Justification and Peer Comparison interventions, but do not receive the Suggested Alternatives intervention
178149|NCT01454947|O6|Outcome|Suggested Alternatives + Peer Comparison|Participants receive the Suggested Alternatives and Peer Comparison interventions, but do not receive the Accountable Justification intervention
178150|NCT01454947|O5|Outcome|Suggested Alternatives + Accountable Justification|Participants receive the Suggested Alternatives and Accountable Justification interventions, but do not receive the Peer Comparison intervention
178153|NCT01454947|O2|Outcome|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
178154|NCT01454947|O1|Outcome|Control|Participants received no study interventions
178155|NCT01454947|E8|Reported Event|SA, AJ, PC|Participants are given all 3 interventions.
178156|NCT01454947|E7|Reported Event|AJ, PC|Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
178157|NCT01454947|E6|Reported Event|SA, PC|Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
178158|NCT01454947|E5|Reported Event|SA, AJ|Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
178159|NCT01454947|E4|Reported Event|Peer Comparison (PC)|Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
178160|NCT01454947|E3|Reported Event|Accountable Justification (AJ)|Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
178161|NCT01454947|E2|Reported Event|Suggested Alternatives (SA)|Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
178162|NCT01454947|E1|Reported Event|Education Control|Participants do not receive any of the 3 interventions.
178163|NCT01454934|B3|Baseline|Total|Total of all reporting groups
178164|NCT01454934|B2|Baseline|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
178165|NCT01454934|B1|Baseline|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
178166|NCT01454934|P2|Participant Flow|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
178167|NCT01454934|P1|Participant Flow|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
178168|NCT01454934|O2|Outcome|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
178169|NCT01454934|O1|Outcome|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
178170|NCT01454934|O2|Outcome|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
178171|NCT01454934|O1|Outcome|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
178172|NCT01454934|O2|Outcome|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
178173|NCT01454934|O1|Outcome|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
178174|NCT01454934|E2|Reported Event|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
178175|NCT01454934|E1|Reported Event|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
178176|NCT01454830|B3|Baseline|Total|Total of all reporting groups
178177|NCT01454830|B2|Baseline|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
178178|NCT01454830|B1|Baseline|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
178272|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178273|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178179|NCT01454830|P2|Participant Flow|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
178180|NCT01454830|P1|Participant Flow|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
178181|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
178182|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
178183|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
178184|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
178185|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
178186|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
178187|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
178188|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
178189|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
178190|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
178191|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
178192|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
178193|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
178274|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178275|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178194|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
178195|NCT01454830|E2|Reported Event|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
178196|NCT01454830|E1|Reported Event|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
178197|NCT01454791|B3|Baseline|Total|Total of all reporting groups
178198|NCT01454791|B2|Baseline|Placebo Followed by Diclofenac Sodium Gel|"placebo for 2 weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
Placebo: a placebo gel is applied 1-4 times per day for two weeks."
178199|NCT01454791|B1|Baseline|Diclofenac Sodium Topical Gel Followed by Placebo|"diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo
Placebo: a placebo gel is applied 1-4 times per day for two weeks."
178200|NCT01454791|P2|Participant Flow|Placebo Followed by Diclofenac Sodium Topical Gel|"Placebo for two weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
Placebo: a placebo gel is applied 1-4 times per day for two weeks."
178201|NCT01454791|P1|Participant Flow|Diclofenac Sodium Topical Gel Followed by Placebo|"diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo
Placebo: a placebo gel is applied 1-4 times per day for two weeks."
178202|NCT01454791|O2|Outcome|Placebo|Placebo for two weeks: a placebo gel is applied 1-4 times per day
178203|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
178204|NCT01454791|O2|Outcome|Placebo|Placebo for 2 weeks: a placebo gel is applied 1-4 times per day
178205|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
178206|NCT01454791|O2|Outcome|Placebo|Placebo for 2 weeks: a placebo gel is applied 1-4 times per day.
178207|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
178208|NCT01454791|E2|Reported Event|Placebo|"1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).
diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo
Placebo: a placebo gel is applied 1-4 times per day for two weeks."
178209|NCT01454791|E1|Reported Event|Diclofenac Sodium Topical Gel|"1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).
diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo
Placebo: a placebo gel is applied 1-4 times per day for two weeks."
178210|NCT01454778|B1|Baseline|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
Paclitaxel Dosage:
Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
not to exceed 10mg total dose"
178211|NCT01454778|P1|Participant Flow|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
Paclitaxel Dosage:
Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
not to exceed 10mg total dose"
178212|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
Paclitaxel Dosage:
Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
not to exceed 10mg total dose"
178213|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
Paclitaxel Dosage:
Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
not to exceed 10mg total dose"
178214|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
Paclitaxel Dosage:
Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
not to exceed 10mg total dose"
178215|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
Paclitaxel Dosage:
Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
not to exceed 10mg total dose"
178276|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178277|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178216|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
Paclitaxel Dosage:
Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
not to exceed 10mg total dose"
178217|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
Paclitaxel Dosage:
Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
not to exceed 10mg total dose"
178218|NCT01454778|E1|Reported Event|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
Paclitaxel Dosage:
Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
not to exceed 10mg total dose"
178219|NCT01454726|B3|Baseline|Total|Total of all reporting groups
178220|NCT01454726|B2|Baseline|Control Group|receiving the Western medical treatment alone.
178221|NCT01454726|B1|Baseline|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
178222|NCT01454726|P2|Participant Flow|Control Group|receiving the Western medical treatment alone.
178223|NCT01454726|P1|Participant Flow|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
178224|NCT01454726|O2|Outcome|Control Group|receiving the Western medical treatment alone.
178225|NCT01454726|O1|Outcome|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
178226|NCT01454726|E2|Reported Event|Control Group|receiving the Western medical treatment alone.
178227|NCT01454726|E1|Reported Event|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
178228|NCT01454583|B4|Baseline|Total|Total of all reporting groups
178229|NCT01454583|B3|Baseline|Group C|Patients without any RAS inhibition (No-RAS-I)
178230|NCT01454583|B2|Baseline|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178231|NCT01454583|B1|Baseline|Group A|Patients treated with Aliskiren (DRI)
178232|NCT01454583|P3|Participant Flow|No RAS-inhibition|Patients treated with no RAS-inhibition drugs at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
178233|NCT01454583|P2|Participant Flow|ACE-I/ARB|Patients treated with ACE-I or ARB (ARB/ACE-I) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
178234|NCT01454583|P1|Participant Flow|Aliskiren|Patients treated with Aliskiren (DRI) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
178235|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178236|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178237|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178238|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178239|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178240|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178241|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178242|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178243|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178244|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178245|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178246|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178247|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178248|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178249|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178250|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178251|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178252|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178253|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178254|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178255|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178256|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178257|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178258|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178259|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178260|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178261|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178262|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178263|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178264|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178265|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178266|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178267|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178268|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178269|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178270|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178271|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178284|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178285|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178286|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178287|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178288|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178289|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178290|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178291|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178292|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178293|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178294|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178295|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
178296|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178297|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
178298|NCT01454583|E3|Reported Event|Group C|Patients without any RAS inhibition (No-RAS-I)
178299|NCT01454583|E2|Reported Event|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
178300|NCT01454583|E1|Reported Event|Group A|Patients treated with Aliskiren (DRI)
178301|NCT01454531|B1|Baseline|AVANZ Phleum Pratense|"AVANZ Phleum pratense
AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
178302|NCT01454531|P1|Participant Flow|AVANZ Phleum Pratense|"AVANZ Phleum pratense
AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
178303|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense
AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
178304|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense
AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
178305|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense
AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
178306|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense
AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
178307|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense
AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
178308|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense
AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
178309|NCT01454531|E1|Reported Event|AVANZ Phleum Pratense|"AVANZ Phleum pratense
AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
178310|NCT01454505|B4|Baseline|Total|Total of all reporting groups
178311|NCT01454505|B3|Baseline|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
178312|NCT01454505|B2|Baseline|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
178313|NCT01454505|B1|Baseline|Stage A/Healthy Volunteers|AL-53817 nasal spray solution in 1 of 3 concentration doses, 1 or 2 sprays per nostril, OR Vehicle, 1 spray per nostril
178314|NCT01454505|P4|Participant Flow|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
178315|NCT01454505|P3|Participant Flow|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
178316|NCT01454505|P2|Participant Flow|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
178317|NCT01454505|P1|Participant Flow|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
178318|NCT01454505|O2|Outcome|Stage B/Vehicle|Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
178319|NCT01454505|O1|Outcome|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
178320|NCT01454505|O2|Outcome|Stage B/Vehicle|Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
178321|NCT01454505|O1|Outcome|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
178322|NCT01454505|O2|Outcome|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
178323|NCT01454505|O1|Outcome|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
178324|NCT01454505|E4|Reported Event|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
178325|NCT01454505|E3|Reported Event|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
178326|NCT01454505|E2|Reported Event|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
178327|NCT01454505|E1|Reported Event|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
178328|NCT01454414|B3|Baseline|Total|Total of all reporting groups
178329|NCT01454414|B2|Baseline|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
178330|NCT01454414|B1|Baseline|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.
Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
178331|NCT01454414|P2|Participant Flow|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
178332|NCT01454414|P1|Participant Flow|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.
Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
178333|NCT01454414|O2|Outcome|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
178334|NCT01454414|O1|Outcome|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.
Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
178335|NCT01454414|E2|Reported Event|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
178336|NCT01454414|E1|Reported Event|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.
Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
178337|NCT01454401|B1|Baseline|LeucoPatch Treatment of Diabetic Foot Ulcers|"Weekly treatment
LeucoPatch device: weekly treatment"
178338|NCT01454401|P1|Participant Flow|LeucoPatch Treatment of Diabetic Foot Ulcers|Weekly LeucoPatch treatment of diabetic foot ulcers
178339|NCT01454401|O1|Outcome|LeucoPatch|LeucoPatch: weekly treatment
178340|NCT01454401|O1|Outcome|LeucoPatch|LeucoPatch: weekly treatment
178341|NCT01454401|E1|Reported Event|All Patients Consenting to be Enrolled in the Study.|"60 patients were included for a 2 week run-in period. If ulcer area decreased more than 40% during that time the ulcer were deemed healing and NOT included for treatment. 16 patients were excluded during the run-in period - 44 were treated. For safety analysis all patients were included"
178342|NCT01454258|B1|Baseline|Cohort|Surgical patients from 10 hospitals over a period of 13 months
178343|NCT01454258|P1|Participant Flow|Cohort|Surgical patients from 10 hospitals over a period of 13 months
178344|NCT01454258|O3|Outcome|Other Colloids|gelatine, albumin,
178345|NCT01454258|O2|Outcome|Hydroxyethyl Starch|
178346|NCT01454258|O1|Outcome|Crystalloids|
178347|NCT01454258|E1|Reported Event|Cohort|Surgical patients
178348|NCT01454063|B3|Baseline|Total|Total of all reporting groups
178349|NCT01454063|B2|Baseline|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178350|NCT01454063|B1|Baseline|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178351|NCT01454063|P2|Participant Flow|Placebo|"Placebo diluted in Balanced Salt Solution (BSS) and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178352|NCT01454063|P1|Participant Flow|OMS302|"OMS302 diluted in Balanced Salt Solution (BSS) and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178353|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178354|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178355|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178356|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178533|NCT01453569|E2|Reported Event|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
178357|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178358|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178359|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178360|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178361|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178362|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178363|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178364|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178365|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178366|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178367|NCT01454063|E2|Reported Event|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178382|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
179038|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
178368|NCT01454063|E1|Reported Event|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
178369|NCT01453998|B4|Baseline|Total|Total of all reporting groups
178370|NCT01453998|B3|Baseline|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178371|NCT01453998|B2|Baseline|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178372|NCT01453998|B1|Baseline|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178373|NCT01453998|P3|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178374|NCT01453998|P2|Participant Flow|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178375|NCT01453998|P1|Participant Flow|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178376|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178377|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178378|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178379|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178380|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178381|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
179039|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
178383|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178384|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178385|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178386|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178387|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178388|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178389|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178390|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178391|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178392|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178393|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178394|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178395|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178462|NCT01453855|E1|Reported Event|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
178463|NCT01453725|B3|Baseline|Total|Total of all reporting groups
178396|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178397|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178398|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178399|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178400|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178401|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178402|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178403|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178404|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178405|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178406|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178407|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178408|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178534|NCT01453569|E1|Reported Event|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
179165|NCT01451554|O1|Outcome|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
178409|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178410|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178411|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178412|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178413|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178414|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178415|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178416|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178417|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178418|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178419|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178420|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178421|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178464|NCT01453725|B2|Baseline|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
179166|NCT01451554|E2|Reported Event|Usual Care|Provided with self-help booklets on diet and exercise.
178422|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178423|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178424|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178425|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178426|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178427|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178428|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178429|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178430|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178431|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178432|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178433|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178434|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178530|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
179167|NCT01451554|E1|Reported Event|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
178435|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178436|NCT01453998|E3|Reported Event|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178437|NCT01453998|E2|Reported Event|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178438|NCT01453998|E1|Reported Event|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
178439|NCT01453946|B1|Baseline|Entocort|Entocort 6 mg/day
178440|NCT01453946|P1|Participant Flow|Entocort|Entocort 6 mg/day
178441|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
178442|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
178443|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
178444|NCT01453946|E1|Reported Event|Entocort|Entocort 6 mg/day
178445|NCT01453894|B3|Baseline|Total|Total of all reporting groups
178446|NCT01453894|B2|Baseline|Usual Care Control Group|Patients assigned to this arm will receive usual care.
178447|NCT01453894|B1|Baseline|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.
Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
178448|NCT01453894|P2|Participant Flow|Usual Care Control Group|Patients assigned to this arm will receive usual care.
178449|NCT01453894|P1|Participant Flow|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.
Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
178450|NCT01453894|O2|Outcome|Usual Care Control Group|Patients assigned to this arm will receive usual care.
178451|NCT01453894|O1|Outcome|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.
Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
178452|NCT01453894|E2|Reported Event|Usual Care Control Group|Patients assigned to this arm will receive usual care.
178453|NCT01453894|E1|Reported Event|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.
Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
178454|NCT01453855|B3|Baseline|Total|Total of all reporting groups
178455|NCT01453855|B2|Baseline|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
178456|NCT01453855|B1|Baseline|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
178457|NCT01453855|P2|Participant Flow|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
178458|NCT01453855|P1|Participant Flow|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
178459|NCT01453855|O2|Outcome|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
178460|NCT01453855|O1|Outcome|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
178461|NCT01453855|E2|Reported Event|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
178465|NCT01453725|B1|Baseline|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
178466|NCT01453725|P2|Participant Flow|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
178467|NCT01453725|P1|Participant Flow|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
178468|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
178469|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
178470|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
178471|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
178472|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
178473|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
178474|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
178475|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
178476|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
178477|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
178478|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
178479|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
178480|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
178481|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
178482|NCT01453725|E4|Reported Event|Part 2: Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
178483|NCT01453725|E3|Reported Event|Part 2: Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
178484|NCT01453725|E2|Reported Event|Part 1: Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
178531|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
178532|NCT01453569|E3|Reported Event|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
178485|NCT01453725|E1|Reported Event|Part 1: Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
178486|NCT01452529|B3|Baseline|Total|Total of all reporting groups
178487|NCT01452529|B2|Baseline|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets
Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
178488|NCT01452529|B1|Baseline|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
178489|NCT01452529|P3|Participant Flow|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets
Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
178490|NCT01452529|P2|Participant Flow|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
178491|NCT01452529|P1|Participant Flow|Open-label Run-in Dose-titration Period Hydrocodone Bitartrate|The open-label run-in dose-titration period was designed to assess subjects qualification for randomization
178492|NCT01452529|O2|Outcome|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets
Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
178493|NCT01452529|O1|Outcome|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
178494|NCT01452529|E3|Reported Event|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets
Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
178495|NCT01452529|E2|Reported Event|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
178496|NCT01452529|E1|Reported Event|Open-label Run-in Dose-titration Period Hydrocodone Bitartrate|The open-label run-in dose-titration period was designed to assess subjects' qualification for randomization
178497|NCT01452425|B1|Baseline|Tourniquet|No adverse event
178498|NCT01452425|P1|Participant Flow|Tourniquet|"Inflation of a tourniquet
Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion"
178499|NCT01452425|O1|Outcome|Tourniquet|
178500|NCT01452425|O1|Outcome|Tourniquet|"Inflation of a tourniquet
Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion"
178501|NCT01452425|E1|Reported Event|Tourniquet|No adverse event
178502|NCT01453595|B4|Baseline|Total|Total of all reporting groups
178503|NCT01453595|B3|Baseline|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
178504|NCT01453595|B2|Baseline|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
178505|NCT01453595|B1|Baseline|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
178506|NCT01453595|P3|Participant Flow|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
178507|NCT01453595|P2|Participant Flow|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
178508|NCT01453595|P1|Participant Flow|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
178509|NCT01453595|O1|Outcome|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
178510|NCT01453595|E3|Reported Event|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
178511|NCT01453595|E2|Reported Event|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
178512|NCT01453595|E1|Reported Event|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
178513|NCT01453569|B4|Baseline|Total|Total of all reporting groups
178514|NCT01453569|B3|Baseline|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
178515|NCT01453569|B2|Baseline|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
178516|NCT01453569|B1|Baseline|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
178517|NCT01453569|P3|Participant Flow|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
178518|NCT01453569|P2|Participant Flow|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
178519|NCT01453569|P1|Participant Flow|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
178520|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
178521|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
178522|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
178523|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
178524|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
178525|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
178526|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
178527|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
178528|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
178529|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
178535|NCT01453413|B1|Baseline|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
178536|NCT01453413|P1|Participant Flow|People With Type 2 Diabetes|Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference
178537|NCT01453413|O1|Outcome|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
178538|NCT01453413|O1|Outcome|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
178539|NCT01453413|E1|Reported Event|People With Type 2 Diabetes|Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference
178540|NCT01453387|B3|Baseline|Total|Total of all reporting groups
178541|NCT01453387|B2|Baseline|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
178542|NCT01453387|B1|Baseline|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
178543|NCT01453387|P2|Participant Flow|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
178544|NCT01453387|P1|Participant Flow|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
178545|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
178546|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
178547|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
178548|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
178549|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
178550|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
178551|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178552|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178553|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178554|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178555|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178556|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178557|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178558|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178559|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178560|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178561|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178562|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178563|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178564|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178565|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178566|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178567|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178568|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178569|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178570|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178571|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178572|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178573|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178574|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178575|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178576|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178577|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178578|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178579|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178580|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178581|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178582|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178583|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178584|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178585|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178586|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178587|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178588|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178589|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178590|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178591|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178592|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178593|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178594|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178595|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178596|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178597|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178598|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178599|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178600|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178601|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178602|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178603|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178604|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
179168|NCT01451541|B4|Baseline|Total|Total of all reporting groups
178605|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178606|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178607|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178608|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178609|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178610|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178611|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178612|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178613|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
178614|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|The planned dose of MSC2015103B (150 mcg and 200 mcg) was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178615|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|The planned dose of MSC2015103B (150 mcg, 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg) was orally administered once weekly on Days 1, 8, and 15 of a 21-day cycle.
178616|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|The planned dose of MSC2015103B (150 mcg and 200 mcg) was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
178617|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|The planned dose of MSC2015103B (150 mcg, 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg) was orally administered once weekly on Days 1, 8, and 15 of a 21-day cycle.
178618|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
178619|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
178620|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
178621|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
178622|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
178623|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
178624|NCT01453387|E2|Reported Event|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
178625|NCT01453387|E1|Reported Event|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
178626|NCT01453374|B1|Baseline|VIVITROL|"380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly"
178627|NCT01453374|P1|Participant Flow|VIVITROL|"380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly"
178628|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly"
178629|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
178630|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
178631|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly"
178632|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly"
178633|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly"
178634|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly"
178635|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
178636|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
178637|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
178638|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
178639|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
178640|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
178641|NCT01453374|E1|Reported Event|VIVITROL|"380 mg IM injection
VIVITROL 380mg: 380 mg IM injection given once monthly"
178642|NCT01453348|B4|Baseline|Total|Total of all reporting groups
178643|NCT01453348|B3|Baseline|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
179040|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
178644|NCT01453348|B2|Baseline|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
178645|NCT01453348|B1|Baseline|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
178646|NCT01453348|P3|Participant Flow|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
178647|NCT01453348|P2|Participant Flow|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
178648|NCT01453348|P1|Participant Flow|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
178649|NCT01453348|O3|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
178650|NCT01453348|O2|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
178651|NCT01453348|O1|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
178652|NCT01453348|O2|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
178653|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
178654|NCT01453348|O2|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
178655|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
178656|NCT01453348|O2|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
178657|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
178658|NCT01453348|O2|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
178659|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
178660|NCT01453348|E3|Reported Event|ACWY|Subject ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
178661|NCT01453348|E2|Reported Event|HepA/B+ACWY|Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
178662|NCT01453348|E1|Reported Event|HepA/B|Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
178663|NCT01453296|B1|Baseline|VI 25 µg/Placebo or Placebo/VI 25 µg|Participants received either vilanterol (VI) 25 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by a repeat dose of the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled VI 25 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178664|NCT01453296|P2|Participant Flow|Sequence 2: Placebo Followed by VI 25 µg|Participants received placebo and VI 25 µg in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
178665|NCT01453296|P1|Participant Flow|Sequence 1: VI 25 µg Followed by Placebo|Participants received vilanterol (VI) 25 micrograms (µg) and matching placebo in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via ae Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
178666|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178667|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178668|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178669|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178670|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178671|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178672|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178673|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178674|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178675|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178676|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178677|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178678|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178679|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178680|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178681|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178682|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178683|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178684|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178685|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178686|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178687|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178688|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178689|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178690|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178691|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
179041|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
178692|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178693|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178694|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178695|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178696|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178697|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178698|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178699|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178700|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178701|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178702|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178703|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178704|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178705|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178706|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178707|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178708|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178709|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178710|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178711|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178712|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178713|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178714|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
179042|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
178715|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178716|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178717|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178718|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178719|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178720|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178721|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178722|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178723|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178724|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178725|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178726|NCT01453296|E2|Reported Event|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178727|NCT01453296|E1|Reported Event|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178728|NCT01453166|B4|Baseline|Total|Total of all reporting groups
178729|NCT01453166|B3|Baseline|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
178730|NCT01453166|B2|Baseline|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
178731|NCT01453166|B1|Baseline|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
178732|NCT01453166|P3|Participant Flow|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
178733|NCT01453166|P2|Participant Flow|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
178765|NCT01453049|P2|Participant Flow|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
207375|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
178734|NCT01453166|P1|Participant Flow|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
178735|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
178736|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
178737|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
178738|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
178739|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
178740|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
178741|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
178742|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
178743|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
178744|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
178745|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
178857|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178746|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
178747|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
178748|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
178749|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
178750|NCT01453166|E3|Reported Event|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
178751|NCT01453166|E2|Reported Event|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
178752|NCT01453166|E1|Reported Event|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
178753|NCT01453075|B3|Baseline|Total|Total of all reporting groups
178754|NCT01453075|B2|Baseline|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily
Placebo: Matching placebo twice daily"
178755|NCT01453075|B1|Baseline|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily
Valacyclovir: Valacyclovir 1.5 mg po bid"
178756|NCT01453075|P2|Participant Flow|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily
Placebo: Matching placebo twice daily"
178757|NCT01453075|P1|Participant Flow|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily
Valacyclovir: Valacyclovir 1.5 mg po bid"
178758|NCT01453075|O2|Outcome|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily
Placebo: Matching placebo twice daily"
178759|NCT01453075|O1|Outcome|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily
Valacyclovir: Valacyclovir 1.5 mg po bid"
178760|NCT01453075|E2|Reported Event|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily
Placebo: Matching placebo twice daily"
178761|NCT01453075|E1|Reported Event|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily
Valacyclovir: Valacyclovir 1.5 mg po bid"
178762|NCT01453049|B3|Baseline|Total|Total of all reporting groups
178763|NCT01453049|B2|Baseline|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178764|NCT01453049|B1|Baseline|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178856|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
207376|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
178766|NCT01453049|P1|Participant Flow|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178767|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178768|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178769|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178770|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178771|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178772|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178773|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178774|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178775|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178776|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178777|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178778|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178938|NCT01452347|E2|Reported Event|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
178779|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178780|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178781|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178782|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178783|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178784|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178785|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178786|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178787|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178788|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178789|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178790|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178791|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178805|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178792|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178793|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178794|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178795|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178796|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178797|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178798|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178799|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178800|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178801|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178802|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178803|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178804|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178939|NCT01452347|E1|Reported Event|Dabigatran Etexilate|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
178940|NCT01452269|B3|Baseline|Total|Total of all reporting groups
178806|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178807|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178808|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178809|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178810|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178811|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178812|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178813|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178814|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178815|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178816|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178817|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178818|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
179043|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
179212|NCT01451541|E1|Reported Event|Placebo|Placebo: placebo - one dose per nostril
178819|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178820|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178821|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178822|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178823|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178824|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178825|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178826|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178827|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178828|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178829|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178830|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178831|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178855|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
179044|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
178832|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178833|NCT01453049|E2|Reported Event|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178834|NCT01453049|E1|Reported Event|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
178835|NCT01453036|B4|Baseline|Total|Total of all reporting groups
178836|NCT01453036|B3|Baseline|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks
178837|NCT01453036|B2|Baseline|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
178838|NCT01453036|B1|Baseline|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
178839|NCT01453036|P3|Participant Flow|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
178840|NCT01453036|P2|Participant Flow|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
178841|NCT01453036|P1|Participant Flow|Conventional AOC Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
178842|NCT01453036|O3|Outcome|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks
178843|NCT01453036|O2|Outcome|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
178844|NCT01453036|O1|Outcome|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
178845|NCT01453036|E3|Reported Event|Mutation Test Group|
178846|NCT01453036|E2|Reported Event|Convential AOM Group|
178847|NCT01453036|E1|Reported Event|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
178848|NCT01453023|B1|Baseline|FF 100 µg/VI 25 µg and FF 100 µg in TPs 1 and 2|All participants who received FF 100 µg/VI 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2 or FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
178849|NCT01453023|P2|Participant Flow|FF 100 µg in TP 1 and FF 100 µg/VI 25 µg in TP 2|Participants received FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
178850|NCT01453023|P1|Participant Flow|FF 100 µg/VI 25 µg in TP 1 and FF 100 µg in TP 2|Participants received fluticasone furoate (FF) 100 micrograms (µg)/Vilanterol (VI) 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
178851|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178852|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178853|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178854|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
179045|NCT01451775|E3|Reported Event|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
179213|NCT01451437|B10|Baseline|Total|Total of all reporting groups
178858|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178859|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178860|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178861|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178862|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178863|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178864|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178865|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178866|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178867|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178868|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178869|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178870|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178871|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178872|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178873|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178874|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178875|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178876|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178877|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178878|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178879|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178880|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178881|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
207377|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
178882|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178883|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178884|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178885|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178886|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178887|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178888|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178889|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178890|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178891|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178892|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178893|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178894|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178895|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178896|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178897|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178898|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178899|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178900|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178901|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178902|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178903|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178904|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178905|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
207378|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
178906|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178907|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178908|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178909|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178910|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178911|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178912|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178913|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178914|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178915|NCT01453023|E2|Reported Event|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178916|NCT01453023|E1|Reported Event|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
178917|NCT01452854|B1|Baseline|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
178918|NCT01452854|P1|Participant Flow|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
178919|NCT01452854|O1|Outcome|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
178920|NCT01452854|E1|Reported Event|Cancer|"The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
Low recruitment necessitated the closing of the study. No results available."
178921|NCT01452347|B3|Baseline|Total|Total of all reporting groups
178922|NCT01452347|B2|Baseline|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
178923|NCT01452347|B1|Baseline|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
178924|NCT01452347|P2|Participant Flow|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
178925|NCT01452347|P1|Participant Flow|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
178926|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
178927|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
178928|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
178929|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
178930|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
178931|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
178932|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
178933|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
178934|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
178935|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
178936|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
178937|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the pharmacokinetic set (PKS) who have a corresponding predicted value.
207379|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
178941|NCT01452269|B2|Baseline|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178942|NCT01452269|B1|Baseline|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178943|NCT01452269|P2|Participant Flow|Delayed Intervention Group|"This arm received the Group intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178944|NCT01452269|P1|Participant Flow|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178945|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178946|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178947|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178962|NCT01452152|O1|Outcome|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
178963|NCT01452152|E3|Reported Event|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
178948|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178949|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178950|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178951|NCT01452269|E2|Reported Event|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178952|NCT01452269|E1|Reported Event|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.
Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).
The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
178953|NCT01452152|B4|Baseline|Total|Total of all reporting groups
178954|NCT01452152|B3|Baseline|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
178955|NCT01452152|B2|Baseline|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
178956|NCT01452152|B1|Baseline|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
178957|NCT01452152|P3|Participant Flow|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
178958|NCT01452152|P2|Participant Flow|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
178959|NCT01452152|P1|Participant Flow|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
178960|NCT01452152|O3|Outcome|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
178961|NCT01452152|O2|Outcome|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
178964|NCT01452152|E2|Reported Event|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.
prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
178965|NCT01452152|E1|Reported Event|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.
clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
178966|NCT01452126|B1|Baseline|Ropivacaine|Each patient received ropivacaine-based nerve blockade at a fixed volume, with concentration determined per protocol
178967|NCT01452126|P1|Participant Flow|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient
Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
178968|NCT01452126|O1|Outcome|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient
Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
178969|NCT01452126|O4|Outcome|Popliteal Nerve Block|Ropivacaine-based blockade of the popliteal nerve, with concentration per protocol.
178970|NCT01452126|O3|Outcome|Infraclavicular Blockade|Ropivacaine-based blockade of the brachial plexus nerves via an infraclavicular approach, with concentration per protocol.
178971|NCT01452126|O2|Outcome|Supraclavicular Blockade|Ropivacaine-based blockade of the brachial plexus nerves via a supraclavicular approach, with concentration per protocol.
178972|NCT01452126|O1|Outcome|Femoral Nerve Block|Ropivacaine-based blockade of the femoral nerve, with concentration per protocol.
178973|NCT01452126|E1|Reported Event|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient
Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
178974|NCT01451983|B5|Baseline|Total|Total of all reporting groups
178975|NCT01451983|B4|Baseline|Siblings|Siblings of individuals with autism spectrum disorders.
178976|NCT01451983|B3|Baseline|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
178977|NCT01451983|B2|Baseline|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
178978|NCT01451983|B1|Baseline|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
178979|NCT01451983|P4|Participant Flow|Siblings|Siblings of individuals with autism spectrum disorders.
178980|NCT01451983|P3|Participant Flow|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
178981|NCT01451983|P2|Participant Flow|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
178982|NCT01451983|P1|Participant Flow|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
178983|NCT01451983|O4|Outcome|Siblings|Siblings of individuals with autism spectrum disorders.
178984|NCT01451983|O3|Outcome|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
178985|NCT01451983|O2|Outcome|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
178986|NCT01451983|O1|Outcome|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
178987|NCT01451983|E4|Reported Event|Siblings|Siblings of individuals with autism spectrum disorders.
178988|NCT01451983|E3|Reported Event|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
178989|NCT01451983|E2|Reported Event|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
178990|NCT01451983|E1|Reported Event|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
178991|NCT01451931|B4|Baseline|Total|Total of all reporting groups
178992|NCT01451931|B3|Baseline|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.
CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
178993|NCT01451931|B2|Baseline|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.
Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
178994|NCT01451931|B1|Baseline|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
178995|NCT01451931|P3|Participant Flow|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.
CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
178996|NCT01451931|P2|Participant Flow|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.
Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
178997|NCT01451931|P1|Participant Flow|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
178998|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.
CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
178999|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.
Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
179000|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
179001|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.
CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
179002|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.
Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
179003|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
179004|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.
CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
179005|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.
Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
179006|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
179007|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.
CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
179008|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.
Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
179009|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
179010|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.
CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
179011|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.
Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
179012|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
179013|NCT01451931|E3|Reported Event|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.
CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
179014|NCT01451931|E2|Reported Event|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.
Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
179015|NCT01451931|E1|Reported Event|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
179016|NCT01451814|B3|Baseline|Total|Total of all reporting groups
179017|NCT01451814|B2|Baseline|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition
Nicotine polacrilex: 8 weeks of nicotine patch
Relaxation training: Instructions in progressive muscle relaxation
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179018|NCT01451814|B1|Baseline|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Nicotine polacrilex: 8 weeks of nicotine patch
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179019|NCT01451814|P2|Participant Flow|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition
Nicotine polacrilex: 8 weeks of nicotine patch
Relaxation training: Instructions in progressive muscle relaxation
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179020|NCT01451814|P1|Participant Flow|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Nicotine polacrilex: 8 weeks of nicotine patch
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179021|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition
Nicotine polacrilex: 8 weeks of nicotine patch
Relaxation training: Instructions in progressive muscle relaxation
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179022|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Nicotine polacrilex: 8 weeks of nicotine patch
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179023|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition
Nicotine polacrilex: 8 weeks of nicotine patch
Relaxation training: Instructions in progressive muscle relaxation
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179024|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Nicotine polacrilex: 8 weeks of nicotine patch
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179025|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition
Nicotine polacrilex: 8 weeks of nicotine patch
Relaxation training: Instructions in progressive muscle relaxation
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179026|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Nicotine polacrilex: 8 weeks of nicotine patch
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179027|NCT01451814|E2|Reported Event|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition
Nicotine polacrilex: 8 weeks of nicotine patch
Relaxation training: Instructions in progressive muscle relaxation
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179028|NCT01451814|E1|Reported Event|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
Nicotine polacrilex: 8 weeks of nicotine patch
Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
179029|NCT01451775|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study. This was a randomised 3 period crossover trial. 18 patients were randomised to one of six treatment sequences and treated. The trial was open label with washout periods of at least 7 days between treatments.
179030|NCT01451775|P6|Participant Flow|Empa 10mg Fasted / Empa 25mg Fed / Empa 25mg Fasted|"Patients were administered three treatments in the following order:
A single dose of 10 mg empa after an overnight fast of at least 10 hours.
A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast
A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours."
179031|NCT01451775|P5|Participant Flow|Empa 10mg Fasted / Empa 25mg Fasted / Empa 25mg Fed|"Patients were administered three treatments in the following order:
A single dose of 10 mg empa after an overnight fast of at least 10 hours.
A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast"
179032|NCT01451775|P4|Participant Flow|Empa 25mg Fed / Empa 10mg Fasted / Empa 25mg Fasted|"Patients were administered three treatments in the following order:
A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast
A single dose of 10 mg empa after an overnight fast of at least 10 hours.
A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours."
179033|NCT01451775|P3|Participant Flow|Empa 25mg Fed / Empa 25mg Fasted / Empa 10mg Fasted|"Patients were administered three treatments in the following order:
A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast
A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
A single dose of 10 mg empa after an overnight fast of at least 10 hours."
179034|NCT01451775|P2|Participant Flow|Empa 25mg Fasted / Empa 10mg Fasted / Empa 25mg Fed|"Patients were administered three treatments in the following order:
A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
A single dose of 10 mg empa after an overnight fast of at least 10 hours.
A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast"
179035|NCT01451775|P1|Participant Flow|Empa 25mg Fasted / Empa 25mg Fed / Empa 10mg Fasted|"Patients were administered three treatments in the following order:
A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast
A single dose of 10 mg empa after an overnight fast of at least 10 hours."
179036|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
179037|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
179046|NCT01451775|E2|Reported Event|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
179047|NCT01451775|E1|Reported Event|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
179048|NCT01451762|B4|Baseline|Total|Total of all reporting groups
179049|NCT01451762|B3|Baseline|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
179050|NCT01451762|B2|Baseline|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
179051|NCT01451762|B1|Baseline|Placebo|.9 normal saline IV
179052|NCT01451762|P3|Participant Flow|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
179053|NCT01451762|P2|Participant Flow|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
179054|NCT01451762|P1|Participant Flow|Placebo|.9 normal saline IV
179055|NCT01451762|O3|Outcome|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
179056|NCT01451762|O2|Outcome|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
179057|NCT01451762|O1|Outcome|Placebo|.9 normal saline IV
179058|NCT01451762|E3|Reported Event|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
179059|NCT01451762|E2|Reported Event|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
179060|NCT01451762|E1|Reported Event|Placebo|.9 normal saline IV
179061|NCT01451749|B3|Baseline|Total|Total of all reporting groups
179062|NCT01451749|B2|Baseline|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.
Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
179063|NCT01451749|B1|Baseline|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
179064|NCT01451749|P2|Participant Flow|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.
Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
179065|NCT01451749|P1|Participant Flow|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
179066|NCT01451749|O2|Outcome|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.
Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.
Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
179067|NCT01451749|O1|Outcome|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.
Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
179068|NCT01451749|O2|Outcome|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.
Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.
Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
179069|NCT01451749|O1|Outcome|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.
Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
179070|NCT01451749|O2|Outcome|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.
Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
179071|NCT01451749|O1|Outcome|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
179072|NCT01451749|E2|Reported Event|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.
Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.
Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
179073|NCT01451749|E1|Reported Event|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.
Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
179074|NCT01451723|B3|Baseline|Total|Total of all reporting groups
179075|NCT01451723|B2|Baseline|Placebo|"Matching placebo capsules.
Placebo: Matching placebo capsules"
179076|NCT01451723|B1|Baseline|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.
Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
179077|NCT01451723|P2|Participant Flow|Placebo|"Matching placebo capsules.
Placebo: Matching placebo capsules"
179078|NCT01451723|P1|Participant Flow|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.
Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
179079|NCT01451723|O2|Outcome|Placebo|"Matching placebo capsules.
Placebo: Matching placebo capsules"
179080|NCT01451723|O1|Outcome|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.
Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
179081|NCT01451723|O2|Outcome|Placebo|"Matching placebo capsules.
Placebo: Matching placebo capsules"
179082|NCT01451723|O1|Outcome|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.
Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
179083|NCT01451723|E2|Reported Event|Placebo|"Matching placebo capsules.
Placebo: Matching placebo capsules"
179164|NCT01451554|O2|Outcome|Usual Care|Provided with self-help booklets on diet and exercise.
179084|NCT01451723|E1|Reported Event|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.
Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
179085|NCT01451645|B3|Baseline|Total|Total of all reporting groups
179086|NCT01451645|B2|Baseline|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
179087|NCT01451645|B1|Baseline|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
179088|NCT01451645|P2|Participant Flow|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
179089|NCT01451645|P1|Participant Flow|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
179090|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
179091|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
179092|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
179093|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
179094|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
179095|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
179096|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
179097|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
179098|NCT01451645|E2|Reported Event|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
179099|NCT01451645|E1|Reported Event|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
179100|NCT01451632|B3|Baseline|Total|Total of all reporting groups
179101|NCT01451632|B2|Baseline|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1
MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
179102|NCT01451632|B1|Baseline|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab
MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
179103|NCT01451632|P10|Participant Flow|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW
Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Irinotecan: 180 mg/m2 IV Q2W"
179104|NCT01451632|P9|Participant Flow|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW
Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Irinotecan: 180 mg/m2 IV Q2W"
179105|NCT01451632|P8|Participant Flow|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW
Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
Irinotecan: 180 mg/m2 IV Q2W"
179106|NCT01451632|P7|Participant Flow|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179107|NCT01451632|P6|Participant Flow|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
179108|NCT01451632|P5|Participant Flow|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179109|NCT01451632|P4|Participant Flow|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
179110|NCT01451632|P3|Participant Flow|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179111|NCT01451632|P2|Participant Flow|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
179112|NCT01451632|P1|Participant Flow|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
179113|NCT01451632|O10|Outcome|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW
Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Irinotecan: 180 mg/m2 IV Q2W"
179114|NCT01451632|O9|Outcome|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW
Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Irinotecan: 180 mg/m2 IV Q2W"
179115|NCT01451632|O8|Outcome|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW
Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
Irinotecan: 180 mg/m2 IV Q2W"
179116|NCT01451632|O7|Outcome|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179117|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
179118|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179119|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
179120|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179121|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
179122|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
179123|NCT01451632|O5|Outcome|Part 2: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2
179124|NCT01451632|O4|Outcome|Part 2: 20 mg/kg|MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2
181208|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
179125|NCT01451632|O3|Outcome|Part 1: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
179126|NCT01451632|O2|Outcome|Part 1: 20 mg/kg|MM-121: 20 mg/kg Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
179127|NCT01451632|O1|Outcome|Part 1: 12 mg/kg|MM-121 mg/kg plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
179128|NCT01451632|O5|Outcome|Part 2: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2
179129|NCT01451632|O4|Outcome|Part 2: 20 mg/kg|MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2
179130|NCT01451632|O3|Outcome|Part 1: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
179131|NCT01451632|O2|Outcome|Part 1: 20 mg/kg|MM-121: 20 mg/kg Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
179132|NCT01451632|O1|Outcome|Part 1: 12 mg/kg|MM-121 mg/kg plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
179133|NCT01451632|O10|Outcome|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW
Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Irinotecan: 180 mg/m2 IV Q2W"
179134|NCT01451632|O9|Outcome|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW
Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Irinotecan: 180 mg/m2 IV Q2W"
179135|NCT01451632|O8|Outcome|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW
Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
Irinotecan: 180 mg/m2 IV Q2W"
179136|NCT01451632|O7|Outcome|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179137|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
179138|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179139|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
179140|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179141|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
179142|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
179143|NCT01451632|O2|Outcome|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1
MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
179144|NCT01451632|O1|Outcome|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab
MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
179145|NCT01451632|O2|Outcome|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1
MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
179146|NCT01451632|O1|Outcome|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab
MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
179147|NCT01451632|O8|Outcome|Part 2: Cohort 2|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
179148|NCT01451632|O7|Outcome|Part 2: Cohort 1|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
179149|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179150|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179151|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
179152|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
179153|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
179154|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
179155|NCT01451632|E2|Reported Event|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1
MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
179156|NCT01451632|E1|Reported Event|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab
MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
179157|NCT01451554|B3|Baseline|Total|Total of all reporting groups
179158|NCT01451554|B2|Baseline|Usual Care|Provided with self-help booklets on diet and exercise.
179159|NCT01451554|B1|Baseline|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
179160|NCT01451554|P2|Participant Flow|Usual Care|Provided with self-help booklets on diet and exercise.
179161|NCT01451554|P1|Participant Flow|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
179162|NCT01451554|O2|Outcome|Usual Care|Provided with self-help booklets on diet and exercise.
179163|NCT01451554|O1|Outcome|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
179169|NCT01451541|B3|Baseline|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179170|NCT01451541|B2|Baseline|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179171|NCT01451541|B1|Baseline|Placebo|Placebo: placebo - one dose per nostril
179172|NCT01451541|P3|Participant Flow|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179173|NCT01451541|P2|Participant Flow|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179174|NCT01451541|P1|Participant Flow|Placebo|Placebo: placebo - one dose per nostril
179175|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179176|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179177|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
179178|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179179|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179180|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
179181|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179182|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179183|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
179184|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179185|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179186|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
179187|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179188|NCT01451541|O1|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179189|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179190|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179191|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
179192|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179193|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179194|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
179195|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179196|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179197|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
179198|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179199|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179200|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
179201|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179202|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179203|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
179204|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179205|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179206|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
179207|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179208|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
179209|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
179210|NCT01451541|E3|Reported Event|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
179211|NCT01451541|E2|Reported Event|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
207380|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
179214|NCT01451437|B9|Baseline|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179215|NCT01451437|B8|Baseline|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179216|NCT01451437|B7|Baseline|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179217|NCT01451437|B6|Baseline|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179218|NCT01451437|B5|Baseline|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179219|NCT01451437|B4|Baseline|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179220|NCT01451437|B3|Baseline|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179221|NCT01451437|B2|Baseline|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179222|NCT01451437|B1|Baseline|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179223|NCT01451437|P9|Participant Flow|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179224|NCT01451437|P8|Participant Flow|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179225|NCT01451437|P7|Participant Flow|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179226|NCT01451437|P6|Participant Flow|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179227|NCT01451437|P5|Participant Flow|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179228|NCT01451437|P4|Participant Flow|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179229|NCT01451437|P3|Participant Flow|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179230|NCT01451437|P2|Participant Flow|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179231|NCT01451437|P1|Participant Flow|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179232|NCT01451437|O9|Outcome|Pt 2 Arm A: MK-8242 300 mg BID|Participants to receive MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg to be administered QD in the morning) in Part 2 Arm A.
179233|NCT01451437|O8|Outcome|Pt 2 Arm A: MK-8242 250 mg BID|Participants to receive MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg to be administered QD in the morning) in Part 2 Arm A.
179234|NCT01451437|O7|Outcome|Pt 2 Arm A: MK-8242 210 mg BID|Participants to receive MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg to be administered QD in the morning) in Part 2 Arm A.
179235|NCT01451437|O6|Outcome|Pt 2 Arm A: MK-8242 170 mg BID|Participants to receive MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg to be administered QD in the morning) in Part 2 Arm A.
179236|NCT01451437|O5|Outcome|Pt 2 Arm A: MK-8242 120 mg BID|Participants to receive MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg to be administered QD in the morning) in Part 2 Arm A.
179237|NCT01451437|O4|Outcome|Pt 2 Arm A: MK-8242 250 mg QD|Participants to receive MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
179238|NCT01451437|O3|Outcome|Pt 2 Arm A: MK-8242 120 mg QD|Participants to receive MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
179239|NCT01451437|O2|Outcome|Pt 2 Arm A: MK-8242 60 mg QD|Participants to receive MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
179240|NCT01451437|O1|Outcome|Pt 2 Arm A: MK-8242 30 mg QD|Participants to receive MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
179241|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179242|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179243|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179244|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179375|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks"
179245|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179246|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179247|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179248|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179249|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179250|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179251|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179252|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179253|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179254|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179255|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179256|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179257|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179258|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179259|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179260|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179261|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179262|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179263|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179264|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179265|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179266|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179267|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179268|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179269|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179270|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179271|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179272|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179273|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179274|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179275|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179276|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179277|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179278|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179279|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179280|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179281|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179282|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179283|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179284|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179285|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179286|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179287|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179288|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179289|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179290|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179291|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179292|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179293|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179294|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179295|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179296|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179297|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179298|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179299|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179300|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179301|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179302|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179303|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179304|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179305|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179306|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179307|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179308|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179309|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179310|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179311|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179312|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179313|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179314|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179315|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179316|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179317|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179318|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179319|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179320|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179321|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179322|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179323|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179324|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179325|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179326|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179327|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179328|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179329|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179330|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179331|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179332|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179333|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179334|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179335|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179336|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179337|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179338|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179339|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179340|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179341|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179497|NCT01450800|O1|Outcome|Urine Cultures Performed|All participants in the final analysis were examined
207523|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
179342|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179343|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179344|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179345|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179346|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179347|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179348|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179349|NCT01451437|E9|Reported Event|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
179350|NCT01451437|E8|Reported Event|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
179351|NCT01451437|E7|Reported Event|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
179352|NCT01451437|E6|Reported Event|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
179353|NCT01451437|E5|Reported Event|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
179354|NCT01451437|E4|Reported Event|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179355|NCT01451437|E3|Reported Event|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179356|NCT01451437|E2|Reported Event|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179357|NCT01451437|E1|Reported Event|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
179358|NCT01451424|B5|Baseline|Total|Total of all reporting groups
179359|NCT01451424|B4|Baseline|24 mg Proellex|"24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks"
179360|NCT01451424|B3|Baseline|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 weeks Includes subjects from both arms 1 and 3 (PK group and non-PK groups)"
179361|NCT01451424|B2|Baseline|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks"
179362|NCT01451424|B1|Baseline|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks"
179363|NCT01451424|P4|Participant Flow|24 mg Proellex|"24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
All subjects completed the placebo run-in period and started active dosing."
179364|NCT01451424|P3|Participant Flow|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1, PK group) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks
The first 6 subjects (arm 1) had no placebo run-in period. Arm 3 subjects all completed the placebo run-in period and started active dosing."
179365|NCT01451424|P2|Participant Flow|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
All subjects completed the placebo run-in period and started active dosing."
179366|NCT01451424|P1|Participant Flow|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
All subjects completed the placebo run-in period and started active dosing."
179367|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks"
179368|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
179369|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks"
179370|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks"
179371|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks"
179372|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
179373|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks"
179374|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks"
181209|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
179376|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
179377|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks"
179378|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks"
179379|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks"
179380|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
179381|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks"
179382|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks"
179383|NCT01451424|O5|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks"
179384|NCT01451424|O4|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
179385|NCT01451424|O3|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks"
179386|NCT01451424|O2|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks"
179387|NCT01451424|O1|Outcome|Proellex 12 mg PK Group|"Subjects receiving 12 mg Proellex administered vaginally, and completing a PK arm consisting of 1 x 24 hr PK of Proellex, 14 days of daily Proellex trough measurements, and 1 x 24 hr PK of Proellex after 14 days of daily dosing. 12 mg PK subjects will continue with the protocol as written after the first 2 week period.
Proellex: vaginal suppository, daily, for 12 weeks"
179388|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks"
179389|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
179390|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks"
179391|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks"
179392|NCT01451424|E4|Reported Event|24 mg Proellex|"24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 12 weeks"
179393|NCT01451424|E3|Reported Event|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks"
179394|NCT01451424|E2|Reported Event|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks"
179395|NCT01451424|E1|Reported Event|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks"
179396|NCT01451411|B3|Baseline|Total|Total of all reporting groups
179397|NCT01451411|B2|Baseline|Placebo|Placebo: Intravenous
179398|NCT01451411|B1|Baseline|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179399|NCT01451411|P2|Participant Flow|Placebo|Placebo: Intravenous
179400|NCT01451411|P1|Participant Flow|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179401|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
179402|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179403|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
179404|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179405|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
179406|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179407|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
179408|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179409|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
179410|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179411|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
179412|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179413|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
179414|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179415|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
179416|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179417|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
179418|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179419|NCT01451411|E2|Reported Event|Placebo|Placebo: Intravenous
179420|NCT01451411|E1|Reported Event|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
179421|NCT01451398|B3|Baseline|Total|Total of all reporting groups
179422|NCT01451398|B2|Baseline|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179423|NCT01451398|B1|Baseline|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179424|NCT01451398|P2|Participant Flow|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179425|NCT01451398|P1|Participant Flow|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179426|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179427|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179428|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179429|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179430|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179431|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179432|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179433|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179434|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179435|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179436|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179437|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179438|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179439|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179440|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179441|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179442|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179443|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179444|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179445|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179446|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179447|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179448|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179449|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179450|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179451|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179452|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179453|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
179454|NCT01451398|E2|Reported Event|Technosphere Powder|"technosphere powder (with no insulin) administered via the Gen2 inhaler added to 1 - 3 stable OADs
Technosphere Powder: Placebo Comparator"
179455|NCT01451398|E1|Reported Event|TI Inhalation Powder|"Technosphere® Insulin powder administered via the Gen2 inhaler added to 1 - 3 stable OADs
Technosphere® Insulin: Technosphere® Insulin Inhalation Powder"
179456|NCT01451203|B3|Baseline|Total|Total of all reporting groups
179498|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
181210|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
179457|NCT01451203|B2|Baseline|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179458|NCT01451203|B1|Baseline|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179459|NCT01451203|P2|Participant Flow|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179460|NCT01451203|P1|Participant Flow|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179461|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179462|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179463|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179464|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179465|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179466|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179467|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179468|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179469|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179470|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179471|NCT01451203|E2|Reported Event|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179472|NCT01451203|E1|Reported Event|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
179473|NCT01450813|B5|Baseline|Total|Total of all reporting groups
179474|NCT01450813|B4|Baseline|Group 4|Rocuronium dose 0.6 mg/kg prior to laryngoscopy
179475|NCT01450813|B3|Baseline|Group 3|Rocuronium dose 0.4 mg/kg prior to laryngoscopy
179476|NCT01450813|B2|Baseline|Group 2|Rocuronium dose 0.2 mg/kg prior to laryngoscopy
179477|NCT01450813|B1|Baseline|Group 1|Rocuronium dose 0 mg/kg prior to laryngoscopy
179478|NCT01450813|P4|Participant Flow|Group 4|Rocuronium 0.6 mg/kg
179479|NCT01450813|P3|Participant Flow|Group 3|Rocuronium 0.4 mg/kg
179480|NCT01450813|P2|Participant Flow|Group 2|Rocuronium 0.2 mg/kg
179481|NCT01450813|P1|Participant Flow|Group 1|Saline 0.06 ml/kg
179482|NCT01450813|O2|Outcome|Remifentanil 8 ng/ml|The anesthesia provider will titrate propofol as appropriate throughout the procedure to maintain a BIS level between 45- 60.
179483|NCT01450813|O1|Outcome|Remifentanil 2ng/ml|The anesthesia provider will titrate propofol as appropriate throughout the procedure to maintain a BIS level between 45- 60.
179484|NCT01450813|O4|Outcome|Group 4|Rocuronium 0.6mg/kg
179485|NCT01450813|O3|Outcome|Group 3|Rocuronium 0.4mg/kg
179486|NCT01450813|O2|Outcome|Group 2|Rocuronium 0.2mg/kg
179487|NCT01450813|O1|Outcome|Group 1|Rocuronium 0mg/kg
179488|NCT01450813|E4|Reported Event|Group 4|Rocuronium dose 0.6 mg/kg
179489|NCT01450813|E3|Reported Event|Group 3|Rocuronium dose 0.4 mg/kg
179490|NCT01450813|E2|Reported Event|Group 2|Rocuronium dose 0.2 mg/kg
179491|NCT01450813|E1|Reported Event|Group 1|Rocuronium dose 0 mg/kg
179492|NCT01450800|B3|Baseline|Total|Total of all reporting groups
179493|NCT01450800|B2|Baseline|Placebo|Participants randomized to receive placebo instructed to take placebo 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
179494|NCT01450800|B1|Baseline|Nitrofurantoin|Participants randomized to receive antibiotics instructed to take nitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
179495|NCT01450800|P2|Participant Flow|Placebo|Randomized to placebo 1 tablet daily for each day of catheterization for up to 7 days
179496|NCT01450800|P1|Participant Flow|Nitrofurantoin|Randomized to nitrofurantoin 100mg daily for each day of catheterization for up to 7 days
179499|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
179500|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
179501|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
179502|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
179503|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
179504|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
179505|NCT01450800|O2|Outcome|Placebo|Randomized to placebo 1 tab daily while using a catheter for up to 7 days
179506|NCT01450800|O1|Outcome|Nitrofurantoin|Randomized to nitrofurantoin 100mg daily while using a catheter for up to 7 days
179507|NCT01450800|E2|Reported Event|Placebo|Participants randomized to receive placebo 1 tablet by mouth daily each day of catheterization for up to one week after surgery
179508|NCT01450800|E1|Reported Event|Nitrofurantoin|Participants randomized to receive nitrofurantoin 100mg by mouth daily each day of catheterization for up to one week after surgery
179509|NCT01450787|B3|Baseline|Total|Total of all reporting groups
179510|NCT01450787|B2|Baseline|Non Diabetics|non diabetics over age 40
179511|NCT01450787|B1|Baseline|Diabetics|diabetics over age 40
179512|NCT01450787|P2|Participant Flow|Non Diabetics|non diabetics over age 40
179513|NCT01450787|P1|Participant Flow|Diabetics|diabetics over age 40
179514|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
179515|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
179516|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
179517|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
179518|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
179519|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
179520|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
179521|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
179522|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
179523|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
179524|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
179525|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
179526|NCT01450787|E2|Reported Event|Non Diabetics|non diabetics over age 40
179527|NCT01450787|E1|Reported Event|Diabetics|diabetics over age 40
179528|NCT01450761|B3|Baseline|Total|Total of all reporting groups
179529|NCT01450761|B2|Baseline|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
179530|NCT01450761|B1|Baseline|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
179531|NCT01450761|P2|Participant Flow|Placebo and Platinum/Etoposide|During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with placebo every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
179532|NCT01450761|P1|Participant Flow|Ipilimumab and Platinum/Etoposide|During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with ipilimumab (10 mg/kg IV) every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
179533|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
179534|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
179535|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
179536|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
179537|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
179538|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
179539|NCT01450761|E2|Reported Event|PLACEBO + PLATINUM/ETOPOSIDE|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
179540|NCT01450761|E1|Reported Event|10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
179541|NCT01450696|B3|Baseline|Total|Total of all reporting groups
179542|NCT01450696|B2|Baseline|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179543|NCT01450696|B1|Baseline|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179544|NCT01450696|P2|Participant Flow|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179545|NCT01450696|P1|Participant Flow|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 milligrams per kilogram (mg/kg) on Day 1 of Cycle 1 followed by 6 mg/kg every three weeks (q3w) as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 milligrams per meter-squared (mg/m^2) intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179546|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179547|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179548|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179549|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179550|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179551|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179552|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179605|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
179553|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179554|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179555|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179556|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179557|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179558|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179559|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179560|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179561|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179562|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179563|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179564|NCT01450696|E2|Reported Event|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179565|NCT01450696|E1|Reported Event|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
179566|NCT01450683|B1|Baseline|Itraconazole|"Itraconazole: 600 mg/day oral (PO)
IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
179567|NCT01450683|P1|Participant Flow|Itraconazole|"Itraconazole: 600 mg/day oral (PO)
IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
179940|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179568|NCT01450683|O1|Outcome|Itraconazole|"Itraconazole: 600 mg/day oral (PO)
IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
179569|NCT01450683|E1|Reported Event|Itraconazole|"Itraconazole: 600 mg/day oral (PO)
IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
179570|NCT01450631|B3|Baseline|Total|Total of all reporting groups
179571|NCT01450631|B2|Baseline|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
179572|NCT01450631|B1|Baseline|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
179573|NCT01450631|P2|Participant Flow|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
179574|NCT01450631|P1|Participant Flow|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
179575|NCT01450631|O2|Outcome|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
179576|NCT01450631|O1|Outcome|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
179577|NCT01450631|O2|Outcome|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
179986|NCT01449461|B7|Baseline|Total|Total of all reporting groups
179578|NCT01450631|O1|Outcome|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
179579|NCT01450631|E2|Reported Event|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
179580|NCT01450631|E1|Reported Event|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
179581|NCT01450397|B1|Baseline|XIAFLEX|Patient who have received XIAFLEX
179582|NCT01450397|P1|Participant Flow|XIAFLEX|0.58 mg of Xiaflex injected into a palpable Dupuytren's cord
179583|NCT01450397|O1|Outcome|XIAFLEX|Subjects receiving one Xiaflex injection
179584|NCT01450397|E1|Reported Event|XIAFLEX|Patient who received XIAFLEX
179585|NCT01450319|B1|Baseline|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
179586|NCT01450319|P1|Participant Flow|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
179587|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
179588|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
179589|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
179590|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
179591|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
179592|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
179593|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
179594|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
179595|NCT01450319|E1|Reported Event|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
179596|NCT01450306|B3|Baseline|Total|Total of all reporting groups
179597|NCT01450306|B2|Baseline|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
179598|NCT01450306|B1|Baseline|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
179599|NCT01450306|P2|Participant Flow|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
179600|NCT01450306|P1|Participant Flow|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
179601|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
179602|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
179603|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
179604|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
179606|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
179607|NCT01450306|E2|Reported Event|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
179608|NCT01450306|E1|Reported Event|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
179609|NCT01450189|B4|Baseline|Total|Total of all reporting groups
179610|NCT01450189|B3|Baseline|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.
ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
179611|NCT01450189|B2|Baseline|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179612|NCT01450189|B1|Baseline|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
179613|NCT01450189|P3|Participant Flow|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.
ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
179614|NCT01450189|P2|Participant Flow|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179615|NCT01450189|P1|Participant Flow|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
179616|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179617|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179618|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
181083|NCT01446289|P4|Participant Flow|Infants Placebo|Infants born from mothers who received one injection of saline solution.
179619|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179620|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179621|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179622|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179623|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179624|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179625|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179626|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179627|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179718|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
181084|NCT01446289|P3|Participant Flow|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
179628|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179629|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179630|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179631|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179632|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179633|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179634|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179635|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179636|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179719|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
179720|NCT01450007|E3|Reported Event|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
179637|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179638|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179639|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179640|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179641|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179642|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179643|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179644|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179645|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179721|NCT01450007|E2|Reported Event|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
181085|NCT01446289|P2|Participant Flow|Mothers Placebo|Pregnant women who received one injection of saline solution.
179646|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179647|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179648|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179649|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179650|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179651|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179652|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179653|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179654|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179722|NCT01450007|E1|Reported Event|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
179723|NCT01449955|B3|Baseline|Total|Total of all reporting groups
179724|NCT01449955|B2|Baseline|Placebo|15mg Placebo administered once in pill form
179655|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179656|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179657|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179658|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179659|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179660|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179661|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179662|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179663|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179725|NCT01449955|B1|Baseline|Rapamycin|15mg Rapamycin administered once in pill form
179726|NCT01449955|P2|Participant Flow|Placebo|15mg Placebo administered once in pill form
179727|NCT01449955|P1|Participant Flow|Rapamycin (e.g., Sirolimus)|15mg Rapamycin administered once in pill form
179664|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179665|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179666|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179667|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179668|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179669|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179670|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179671|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179672|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179728|NCT01449955|O2|Outcome|Placebo|15 mg Placebo administered once in pill form
179729|NCT01449955|O1|Outcome|Rapamycin (e.g., Sirolimus)|15mg Rapamycin administered once in pill form
179730|NCT01449955|E2|Reported Event|Placebo|Placebo arm
179731|NCT01449955|E1|Reported Event|Rapamycin|15mg Rapamycin
179673|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179674|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179675|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179676|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179677|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179678|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179679|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179680|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179681|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179732|NCT01449929|B3|Baseline|Total|Total of all reporting groups
179733|NCT01449929|B2|Baseline|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
214780|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
179682|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179683|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179684|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179685|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
179686|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179687|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
179688|NCT01450189|O3|Outcome|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.
ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
179689|NCT01450189|O2|Outcome|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179690|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
179691|NCT01450189|O1|Outcome|Combined Behavioral Intervention Arms|Both the behavioral intervention and behavioral intervention plus antiretroviral arms are combined in this outcome
179734|NCT01449929|B1|Baseline|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179735|NCT01449929|P2|Participant Flow|DRV 800 mg + RTV 100 mg OD|Participants received darunavir (DRV) 800 mg + ritonavir (RTV) 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179692|NCT01450189|O3|Outcome|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.
ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
179693|NCT01450189|O2|Outcome|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179694|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
179695|NCT01450189|O1|Outcome|Overall|
179696|NCT01450189|O1|Outcome|Overall|
179697|NCT01450189|O1|Outcome|Overall|All arms combined
179698|NCT01450189|E3|Reported Event|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.
ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
179699|NCT01450189|E2|Reported Event|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
179700|NCT01450189|E1|Reported Event|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
179701|NCT01450007|B4|Baseline|Total|Total of all reporting groups
179702|NCT01450007|B3|Baseline|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
179703|NCT01450007|B2|Baseline|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
179704|NCT01450007|B1|Baseline|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
179705|NCT01450007|P3|Participant Flow|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
179706|NCT01450007|P2|Participant Flow|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
179707|NCT01450007|P1|Participant Flow|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
179708|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
179709|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
179710|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
179711|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
179712|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
179713|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
179714|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
179715|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
179716|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
179717|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
179736|NCT01449929|P1|Participant Flow|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) administered in combination with fixed-dose combination (FDC) dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine [ABC/3TC] or tenofovir/emtricitabine [TDF/FTC]) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg OD during an Extension Phase of the study.
179737|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179738|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179739|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179740|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179741|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179742|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179743|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179744|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179745|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179746|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179747|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179748|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179749|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179750|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179751|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179752|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179753|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179754|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179755|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179756|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179757|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179758|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179759|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179760|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179761|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179762|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179763|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179764|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179765|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179766|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179767|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179768|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179769|NCT01449929|E2|Reported Event|Darunavir 800 mg + Ritonavir 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179770|NCT01449929|E1|Reported Event|Dolutegravir 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
179771|NCT01449812|B4|Baseline|Total|Total of all reporting groups
179772|NCT01449812|B3|Baseline|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179773|NCT01449812|B2|Baseline|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179774|NCT01449812|B1|Baseline|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179775|NCT01449812|P3|Participant Flow|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179776|NCT01449812|P2|Participant Flow|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179777|NCT01449812|P1|Participant Flow|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179778|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179779|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179780|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179781|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179782|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179783|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179784|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179785|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179786|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179899|NCT01449708|E2|Reported Event|TIVA|patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
179900|NCT01449708|E1|Reported Event|Classic/Balanced Anesthesia|Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)
179787|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179788|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179789|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179790|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179791|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179792|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179793|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179794|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179795|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179796|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179797|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179798|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179799|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179800|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179801|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179901|NCT01449682|B3|Baseline|Total|Total of all reporting groups
179902|NCT01449682|B2|Baseline|Ozurdex q16 Weeks|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks
Other Name: Ozurdex PRN"
179802|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179803|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179804|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179805|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179806|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179807|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179808|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179809|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179810|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179811|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179812|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179813|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179814|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179815|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179816|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179903|NCT01449682|B1|Baseline|Ozurdex PRN|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks
Other Name: Ozurdex PRN"
181086|NCT01446289|P1|Participant Flow|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
179817|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179818|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179819|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179820|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179821|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179822|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179823|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179824|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179825|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179826|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179827|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179828|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179829|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179830|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179831|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179904|NCT01449682|P2|Participant Flow|Active Comparator: Ozurdex q16 Weeks|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks
Other Name: Ozurdex q16 weeks"
181211|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
179832|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179833|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179834|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179835|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179836|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179837|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179838|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179839|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179840|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179841|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179842|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179843|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179844|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179845|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179846|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179905|NCT01449682|P1|Participant Flow|Active Comparator: Ozurdex PRN|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks
Other Name: Ozurdex PRN"
181212|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
179847|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179848|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179849|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179850|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179851|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179852|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179853|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179854|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179855|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179856|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179857|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179858|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179859|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179860|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179861|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179906|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks
Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
180058|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
179862|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179863|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179864|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179865|NCT01449812|E3|Reported Event|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179866|NCT01449812|E2|Reported Event|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179867|NCT01449812|E1|Reported Event|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
179868|NCT01449747|B3|Baseline|Total|Total of all reporting groups
179869|NCT01449747|B2|Baseline|Responder|Sitagliptin response patients
179870|NCT01449747|B1|Baseline|Non-responder|Sitagliptin non-response patients
179871|NCT01449747|P2|Participant Flow|Responder|Sitagliptin response patients
179872|NCT01449747|P1|Participant Flow|Non-responder|Sitagliptin non-response patients
179873|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
179874|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
179875|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
179876|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
179877|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
179878|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
179879|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
179880|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
179881|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
179882|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
179883|NCT01449747|E2|Reported Event|Responder|Sitagliptin response patients
179884|NCT01449747|E1|Reported Event|Non-responder|Sitagliptin non-response patients
179885|NCT01449734|B1|Baseline|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
179886|NCT01449734|P1|Participant Flow|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
179887|NCT01449734|O1|Outcome|Family Satisfaction|All 215 surveyed relatives are contained in this group, since the study was observational without intervention.
179888|NCT01449734|E1|Reported Event|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
179889|NCT01449708|B3|Baseline|Total|Total of all reporting groups
179890|NCT01449708|B2|Baseline|TIVA|"patients in both groups receive antiemetic prophylaxis
patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
postop management in both groups is similar in both groups"
179891|NCT01449708|B1|Baseline|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.
patients in both groups receive antiemetic prophylaxis
postop management in both groups is similar in both groups"
179892|NCT01449708|P2|Participant Flow|TIVA|"TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis
- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively"
179893|NCT01449708|P1|Participant Flow|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)
postop management in both groups is similar in both groups"
179894|NCT01449708|O1|Outcome|All Study Participants|measure included all119 patients depending on surgical procedure
179895|NCT01449708|O2|Outcome|TIVA|"TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis
- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively"
179896|NCT01449708|O1|Outcome|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)
postop management in both groups is similar in both groups"
179897|NCT01449708|O2|Outcome|TIVA|patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
179898|NCT01449708|O1|Outcome|Classic / Balanced Anesthesia|Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)
217216|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
179907|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT
Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
179908|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks
Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
179909|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT
Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
179910|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks
Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
179911|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT
Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
179912|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks
Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
179913|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT
Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
179914|NCT01449682|E2|Reported Event|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks
Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
179915|NCT01449682|E1|Reported Event|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT
Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
179916|NCT01449539|B1|Baseline|Hyperbaric Oxygen Therapy|Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres for 90 minutes at pressure. Treatment lasts about 2 hours as time is allowed for gradual pressurization and depressurization. Treated for two weeks a total of 10 HBOT treatments.
179917|NCT01449539|P1|Participant Flow|Hyperbaric Oxygen Therapy|Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens
179918|NCT01449539|O1|Outcome|Hyperbaric Oxygen Therapy|Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres (the equivalent of being under 33 feet of sea water) for 90 minutes. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each participant will be treated for two weeks for a total of 10 HBOT treatments.
179919|NCT01449539|E1|Reported Event|Hyperbaric Oxygen Therapy|Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens
179920|NCT01449526|B3|Baseline|Total|Total of all reporting groups
179921|NCT01449526|B2|Baseline|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens
B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
179922|NCT01449526|B1|Baseline|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens
B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
179923|NCT01449526|P2|Participant Flow|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens
B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
179924|NCT01449526|P1|Participant Flow|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens
B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
179925|NCT01449526|O2|Outcome|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens
B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
179926|NCT01449526|O1|Outcome|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens
B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
179927|NCT01449526|O2|Outcome|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens
B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
179928|NCT01449526|O1|Outcome|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens
B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
179929|NCT01449526|E2|Reported Event|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens
B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
179930|NCT01449526|E1|Reported Event|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens
B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
179931|NCT01449513|B3|Baseline|Total|Total of all reporting groups
179932|NCT01449513|B2|Baseline|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179933|NCT01449513|B1|Baseline|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179934|NCT01449513|P2|Participant Flow|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179935|NCT01449513|P1|Participant Flow|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179936|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179937|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179938|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179939|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179941|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179942|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179943|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179944|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179945|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179946|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179947|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179948|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179949|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179950|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179951|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179952|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179953|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179954|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179955|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179956|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179957|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179958|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179959|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179960|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179961|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179962|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179963|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179964|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179965|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179966|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179967|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179968|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179969|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179970|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179971|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179972|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179973|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179974|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179975|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179976|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179977|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179978|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179979|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179980|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179981|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179982|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179983|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179984|NCT01449513|E2|Reported Event|Vehicle|"Vehicle of PEP005 Gel
Vehicle gel once daily on two consecutive days to an 25cm2 area"
179985|NCT01449513|E1|Reported Event|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)
Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
179987|NCT01449461|B6|Baseline|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
179988|NCT01449461|B5|Baseline|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
179989|NCT01449461|B4|Baseline|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
179990|NCT01449461|B3|Baseline|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
179991|NCT01449461|B2|Baseline|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
179992|NCT01449461|B1|Baseline|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
179993|NCT01449461|P6|Participant Flow|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
179994|NCT01449461|P5|Participant Flow|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
179995|NCT01449461|P4|Participant Flow|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
179996|NCT01449461|P3|Participant Flow|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
179997|NCT01449461|P2|Participant Flow|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
179998|NCT01449461|P1|Participant Flow|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
179999|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180000|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
180001|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
180002|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180003|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180004|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180005|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180006|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
180007|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
180008|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180009|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180010|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180011|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180012|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
180013|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
180014|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180015|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180016|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180017|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180018|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
180019|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
181213|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
180020|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180021|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180022|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180023|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180024|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
180025|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
180026|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180027|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180028|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180029|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180030|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
180031|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
180032|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180033|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180034|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180035|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180036|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
180037|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
180038|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180039|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180040|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180041|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180042|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
180043|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180044|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
180045|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180046|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180047|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180048|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180049|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
180050|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180051|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
180052|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180053|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180054|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180055|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180056|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
180057|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180059|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180060|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180061|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180062|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180063|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
180064|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180065|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
180066|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180067|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180068|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180069|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180070|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
180071|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180072|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
180073|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180074|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180075|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180076|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180077|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
180078|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180079|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
180080|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180081|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180082|NCT01449461|O7|Outcome|Brigatinib 300 mg|Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180083|NCT01449461|O6|Outcome|Brigatinib 240 mg|Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180084|NCT01449461|O5|Outcome|Brigatinib 180 mg|Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (approximately, up to 44.4 months).
180085|NCT01449461|O4|Outcome|Brigatinib 120 mg|Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (approximately, up to 44.4 months).
180086|NCT01449461|O3|Outcome|Brigatinib 90 mg|Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (approximately, up to 44.4 months).
180087|NCT01449461|O2|Outcome|Brigatinib 60 mg|Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180088|NCT01449461|O1|Outcome|Brigatinib 30 mg|Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180089|NCT01449461|O1|Outcome|Dose Escalation Phase|Participants received brigatinib tablets, orally, once daily (QD) starting at 30 mg in each cycle of 28 days (approximately, up to 44.4 months).
180090|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180091|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
180092|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
180093|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180094|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180095|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180096|NCT01449461|O6|Outcome|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180097|NCT01449461|O5|Outcome|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
180098|NCT01449461|O4|Outcome|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
180099|NCT01449461|O3|Outcome|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180100|NCT01449461|O2|Outcome|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180101|NCT01449461|O1|Outcome|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180102|NCT01449461|O1|Outcome|Brigatinib|All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days.
180103|NCT01449461|E6|Reported Event|Brigatinib 240 mg QD/120 mg BID/300 mg QD|Brigatinib 240 mg, once daily (QD) or 120 mg, twice daily (BID) or 300 mg once daily, tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180104|NCT01449461|E5|Reported Event|Brigatinib 180 mg QD/90 mg BID|Brigatinib 180 mg, once daily or 90 mg, twice daily (BID), tablets, orally in each cycle of 28 days (approximately, up to 44.4 months).
180105|NCT01449461|E4|Reported Event|Brigatinib 90 mg QD-180 mg QD|Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
180106|NCT01449461|E3|Reported Event|Brigatinib 120 mg QD/60 mg BID|Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (approximately, up to 44.4 months).
180107|NCT01449461|E2|Reported Event|Brigatinib 90 mg QD|Brigatinib 90 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180108|NCT01449461|E1|Reported Event|Brigatinib 30 mg QD/60 mg QD|Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (approximately, up to 44.4 months).
180109|NCT01449370|B26|Baseline|Total|Total of all reporting groups
180110|NCT01449370|B25|Baseline|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180111|NCT01449370|B24|Baseline|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180112|NCT01449370|B23|Baseline|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180113|NCT01449370|B22|Baseline|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180114|NCT01449370|B21|Baseline|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180115|NCT01449370|B20|Baseline|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180116|NCT01449370|B19|Baseline|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180117|NCT01449370|B18|Baseline|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180118|NCT01449370|B17|Baseline|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180119|NCT01449370|B16|Baseline|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180120|NCT01449370|B15|Baseline|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180121|NCT01449370|B14|Baseline|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180122|NCT01449370|B13|Baseline|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180123|NCT01449370|B12|Baseline|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180124|NCT01449370|B11|Baseline|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180125|NCT01449370|B10|Baseline|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180126|NCT01449370|B9|Baseline|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180127|NCT01449370|B8|Baseline|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
217217|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
180128|NCT01449370|B7|Baseline|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180129|NCT01449370|B6|Baseline|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180130|NCT01449370|B5|Baseline|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180131|NCT01449370|B4|Baseline|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180132|NCT01449370|B3|Baseline|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180133|NCT01449370|B2|Baseline|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180134|NCT01449370|B1|Baseline|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180135|NCT01449370|P25|Participant Flow|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180136|NCT01449370|P24|Participant Flow|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180137|NCT01449370|P23|Participant Flow|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180138|NCT01449370|P22|Participant Flow|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180139|NCT01449370|P21|Participant Flow|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180140|NCT01449370|P20|Participant Flow|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180141|NCT01449370|P19|Participant Flow|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180142|NCT01449370|P18|Participant Flow|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180143|NCT01449370|P17|Participant Flow|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180144|NCT01449370|P16|Participant Flow|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180145|NCT01449370|P15|Participant Flow|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180146|NCT01449370|P14|Participant Flow|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180147|NCT01449370|P13|Participant Flow|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180148|NCT01449370|P12|Participant Flow|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180149|NCT01449370|P11|Participant Flow|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180150|NCT01449370|P10|Participant Flow|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180151|NCT01449370|P9|Participant Flow|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180152|NCT01449370|P8|Participant Flow|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180153|NCT01449370|P7|Participant Flow|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180154|NCT01449370|P6|Participant Flow|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180155|NCT01449370|P5|Participant Flow|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180156|NCT01449370|P4|Participant Flow|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180157|NCT01449370|P3|Participant Flow|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180158|NCT01449370|P2|Participant Flow|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180159|NCT01449370|P1|Participant Flow|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180160|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180161|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180162|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180163|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180164|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180165|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180166|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180167|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180168|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180169|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180170|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180171|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180172|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180173|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180174|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180175|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180176|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180177|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180178|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180179|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180180|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180181|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180691|NCT01448057|O1|Outcome|Arm A|Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
180182|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180183|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180184|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180185|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180186|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180187|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180188|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180189|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180190|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180191|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180192|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180193|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180194|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180195|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180196|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180197|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180198|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180199|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180200|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180201|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180202|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180203|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180204|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180205|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180206|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180207|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180208|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180209|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180210|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180211|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180212|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180213|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180214|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180215|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180216|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180217|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180218|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180219|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180220|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180221|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180222|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180223|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180224|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180225|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180226|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180227|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180247|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
217218|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
180228|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180229|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180230|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180231|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180232|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180233|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180234|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180235|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180236|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180237|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180238|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180239|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180240|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180241|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180242|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180243|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180244|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180245|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180246|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
217219|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
180248|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180249|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180250|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180251|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180252|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180253|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180254|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180255|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180256|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180257|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180258|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180259|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180260|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180261|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180262|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180263|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180264|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180265|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180266|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180267|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180268|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180269|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180270|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180271|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180272|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180273|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180274|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180275|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180276|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180277|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180278|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180279|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180280|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180281|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180282|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180283|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180284|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180285|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180306|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180286|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180287|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180288|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180289|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180290|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180291|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
180292|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180293|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180294|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180295|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180296|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180297|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180298|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180299|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
180300|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180301|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180302|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180303|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180304|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180305|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
181214|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
180307|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180308|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180309|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180310|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180311|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180312|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180313|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180314|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180315|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180316|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180317|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180318|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180319|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180320|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180321|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180322|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180323|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180324|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180325|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180326|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180327|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180328|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180329|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180330|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180331|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180332|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180333|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
217220|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
180334|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180335|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180336|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180337|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180338|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180339|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180340|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180341|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180342|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180343|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180344|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180345|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180346|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180347|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180348|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180349|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180350|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180351|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180352|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180353|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180354|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180355|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180356|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180357|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180358|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180359|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180360|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180361|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180362|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180363|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180364|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180365|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180366|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180367|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180368|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180369|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180370|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180371|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180372|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180373|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180374|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180375|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180376|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180377|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180378|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180379|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180380|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180381|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180382|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180383|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180384|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180385|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180386|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180387|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180496|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180388|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180389|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180390|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180391|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180392|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180393|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180394|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180395|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180396|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180397|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180398|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180399|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180400|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180401|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180402|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180403|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180404|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180405|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180406|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180407|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180408|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180409|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180410|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180411|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180412|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180413|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180414|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180692|NCT01448057|E2|Reported Event|Arm B|"Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
180415|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180416|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180417|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180418|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180419|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180420|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180421|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180422|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180423|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180424|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180425|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180426|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180427|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180428|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180429|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180430|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180431|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180432|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180433|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180434|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180435|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180436|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180437|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180438|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180439|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180440|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180441|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180497|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180442|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180443|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180444|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180445|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180446|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180447|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180448|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180449|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180450|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180451|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180452|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180453|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180454|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180455|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180456|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180457|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180458|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180459|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180460|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180461|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180462|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180463|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180464|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180465|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180466|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180467|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180468|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180498|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180469|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180470|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180471|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180472|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180473|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180474|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180475|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180476|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180477|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180478|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180479|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180480|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180481|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180482|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180483|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180484|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180485|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180486|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180487|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180488|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180489|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180490|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180491|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180492|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180493|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180494|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180495|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
181087|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
180499|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180500|NCT01449370|O6|Outcome|Process B: Total FM BID MWF QW 300-600 mg|TAK-117 300-600 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180501|NCT01449370|O5|Outcome|Process B: Total FM MTW QW 600-1500 mg|TAK-117 600-1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180502|NCT01449370|O4|Outcome|Process B: Total FM MWF QW TAK-117 600-1200 mg|TAK-117 600-1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180503|NCT01449370|O3|Outcome|Process A: Total MTW QW 200-900 mg|TAK-117 200-900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180504|NCT01449370|O2|Outcome|Process A: Total MWF QW 200-1200 mg|TAK-117 200-1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180505|NCT01449370|O1|Outcome|Process A: Total QD TAK-117 100-300 mg|TAK-117 100-300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180506|NCT01449370|E25|Reported Event|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180507|NCT01449370|E24|Reported Event|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180508|NCT01449370|E23|Reported Event|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180509|NCT01449370|E22|Reported Event|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180510|NCT01449370|E21|Reported Event|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180511|NCT01449370|E20|Reported Event|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180512|NCT01449370|E19|Reported Event|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180513|NCT01449370|E18|Reported Event|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180514|NCT01449370|E17|Reported Event|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180515|NCT01449370|E16|Reported Event|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180516|NCT01449370|E15|Reported Event|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
180517|NCT01449370|E14|Reported Event|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180518|NCT01449370|E13|Reported Event|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180519|NCT01449370|E12|Reported Event|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180520|NCT01449370|E11|Reported Event|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180521|NCT01449370|E10|Reported Event|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180522|NCT01449370|E9|Reported Event|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180523|NCT01449370|E8|Reported Event|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180524|NCT01449370|E7|Reported Event|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180525|NCT01449370|E6|Reported Event|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180526|NCT01449370|E5|Reported Event|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
180527|NCT01449370|E4|Reported Event|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180528|NCT01449370|E3|Reported Event|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180529|NCT01449370|E2|Reported Event|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180530|NCT01449370|E1|Reported Event|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
180531|NCT01449305|B1|Baseline|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
180532|NCT01449305|P1|Participant Flow|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
180533|NCT01449305|O1|Outcome|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
180534|NCT01449305|O1|Outcome|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
180535|NCT01449305|E1|Reported Event|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
180536|NCT01449279|B1|Baseline|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
180537|NCT01449279|P1|Participant Flow|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
180538|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
180539|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
180551|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years
• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
181088|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
180540|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
180541|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
180542|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
180543|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
180544|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
180545|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
180546|NCT01449279|E1|Reported Event|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
180547|NCT01449266|B1|Baseline|Dotarem®-Injected Patients|"Male or female, aged ≥18 years
• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)
Dotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg)."
180548|NCT01449266|P1|Participant Flow|Dotarem® Injected Patients|"Male or female, aged ≥18 years
• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)
Dotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg)."
180549|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years
• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
180550|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years
• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
181215|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
180552|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years
• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
180553|NCT01449266|E1|Reported Event|Dotarem® Injected Patients|"Male or female, aged ≥18 years
• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)
Dotarem: Dotarem® was administered at a single dose of 0.1 mmoL/kg (0.2 mL/kg)."
180554|NCT01449240|B1|Baseline|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
180555|NCT01449240|P1|Participant Flow|No Investigational Treatment or Control Group|This was an observational study for the collection and study of cerebrospinal fluid (CSF) in patients with Hunter syndrome. No investigational treatment was given.
180556|NCT01449240|O1|Outcome|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
180557|NCT01449240|O1|Outcome|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
180558|NCT01449240|E1|Reported Event|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given. Safety analyses were performed in the Safety Population, which was defined as all patients who had undergone a procedure for CSF sample collection. This included a patient who underwent unsuccessful CSF sample collection; no CSF or urine GAG data were available for this adult patient.
180559|NCT01449006|B3|Baseline|Total|Total of all reporting groups
180560|NCT01449006|B2|Baseline|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.
Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
180561|NCT01449006|B1|Baseline|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
180562|NCT01449006|P2|Participant Flow|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.
Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
180563|NCT01449006|P1|Participant Flow|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
180564|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.
Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
180565|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
180566|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.
Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
180567|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
180568|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.
Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
180569|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
180570|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.
Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
180571|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
180572|NCT01449006|E2|Reported Event|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.
Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
180573|NCT01449006|E1|Reported Event|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
180574|NCT01448850|B3|Baseline|Total|Total of all reporting groups
180575|NCT01448850|B2|Baseline|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180576|NCT01448850|B1|Baseline|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180577|NCT01448850|P2|Participant Flow|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180578|NCT01448850|P1|Participant Flow|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180579|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180580|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180581|NCT01448850|O1|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180582|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180583|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180584|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180585|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180586|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180587|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180588|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180589|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180590|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180591|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180592|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180593|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180594|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180595|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180596|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
180597|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180598|NCT01448850|E2|Reported Event|MEDI8968 300 mg|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 5.
180599|NCT01448850|E1|Reported Event|PLACEBO|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
180600|NCT01448707|B3|Baseline|Total|Total of all reporting groups
180601|NCT01448707|B2|Baseline|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
180602|NCT01448707|B1|Baseline|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
180603|NCT01448707|P2|Participant Flow|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
180604|NCT01448707|P1|Participant Flow|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
180605|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
180606|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
180607|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
180608|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
180609|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
180610|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
181089|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
180611|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
180612|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
180613|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
180614|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
180615|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
180616|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
180617|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
180618|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
180619|NCT01448707|E2|Reported Event|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
180620|NCT01448707|E1|Reported Event|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
180621|NCT01448616|B4|Baseline|Total|Total of all reporting groups
180622|NCT01448616|B3|Baseline|Oral Placebo + Vaginal Placebo Gel|Participants received matching oral tab and placebo gel both to be used daily
180623|NCT01448616|B2|Baseline|Oral Placebo + Vaginal TFV Gel|Participants randomized to receive matching oral placebo tab once daily + tenofovir (TFV) 1% vaginal gel (40mg in 4ml) to be used daily
180624|NCT01448616|B1|Baseline|Oral TDF + Vaginal Placebo Gel|Participants randomized to receive 300mg Tenofovir Disaproxil Fumarate (TDF) 1 tab daily + the universal placebo vaginal gel (4ml) to be used daily.
180625|NCT01448616|P4|Participant Flow|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
180626|NCT01448616|P3|Participant Flow|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
180627|NCT01448616|P2|Participant Flow|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
180628|NCT01448616|P1|Participant Flow|Observational Group|All enrolled participants completed 28 days of twice-daily genital swabbing for HSV DNA. Only women completing >90% of requested swabs were randomized.
180629|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
180630|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
180631|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
180632|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
180633|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg/4ml of TFV gel both to be used daily
180634|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
180635|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
180636|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
180637|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
180638|NCT01448616|O3|Outcome|Oral Placebo + Vaginal Placebo|"placebo tablets: TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.
placebo gel: Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.
The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects — negative or positive — on study endpoints."
180639|NCT01448616|O2|Outcome|Oral Placebo + Vaginal TFV Gel|"Tenofovir: Tenofovir 1% gel (w/w) is a gel formulation of tenofovir. Study participants are instructed to insert one dose (the entire contents of one applicator 40mg/4ml) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.
placebo tablets: TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals."
180687|NCT01448057|P1|Participant Flow|Combination Product|"Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
180640|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"tenofovir disoproxil fumarate (TDF): Oral tenofovir will be administered as tablets. TDF (Viread®) tablets contain 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.
placebo gel: Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.
The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects — negative or positive — on study endpoints."
180641|NCT01448616|E4|Reported Event|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
180642|NCT01448616|E3|Reported Event|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
180643|NCT01448616|E2|Reported Event|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
180644|NCT01448616|E1|Reported Event|Observational Group|All enrolled participants completed 28 days of twice-daily genital swabbing for HSV DNA. Only women completing >90% of requested swabs were randomized.
180645|NCT01448525|B3|Baseline|Total|Total of all reporting groups
180646|NCT01448525|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
180647|NCT01448525|B1|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
180648|NCT01448525|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
180649|NCT01448525|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
180650|NCT01448525|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
180651|NCT01448525|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
180652|NCT01448525|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
180653|NCT01448525|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
180654|NCT01448525|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
180655|NCT01448525|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
180656|NCT01448486|B3|Baseline|Total|Total of all reporting groups
180657|NCT01448486|B2|Baseline|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
180658|NCT01448486|B1|Baseline|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).
Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
180659|NCT01448486|P2|Participant Flow|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
180660|NCT01448486|P1|Participant Flow|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).
Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
180661|NCT01448486|O2|Outcome|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
180662|NCT01448486|O1|Outcome|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).
Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
180663|NCT01448486|O2|Outcome|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
180664|NCT01448486|O1|Outcome|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).
Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
180665|NCT01448486|E2|Reported Event|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
180666|NCT01448486|E1|Reported Event|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).
Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
180667|NCT01448356|B1|Baseline|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
180668|NCT01448356|P1|Participant Flow|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
180669|NCT01448356|O1|Outcome|Temperature and Humidity|average of three measurements
180670|NCT01448356|O1|Outcome|Temperature and Humidity|Tear evaporation of overall surface
180671|NCT01448356|E1|Reported Event|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
180672|NCT01448213|B3|Baseline|Total|Total of all reporting groups
180688|NCT01448057|O2|Outcome|Arm B|"Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
180689|NCT01448057|O1|Outcome|Arm A|Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
180690|NCT01448057|O2|Outcome|Arm B|"Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
180673|NCT01448213|B2|Baseline|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
180674|NCT01448213|B1|Baseline|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
180675|NCT01448213|P2|Participant Flow|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
180676|NCT01448213|P1|Participant Flow|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
180677|NCT01448213|O2|Outcome|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
180678|NCT01448213|O1|Outcome|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
180679|NCT01448213|O2|Outcome|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
180680|NCT01448213|O1|Outcome|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
180681|NCT01448213|E2|Reported Event|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
180682|NCT01448213|E1|Reported Event|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
180683|NCT01448057|B3|Baseline|Total|Total of all reporting groups
180684|NCT01448057|B2|Baseline|Arm B|"Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
180685|NCT01448057|B1|Baseline|Arm A|"Combination Product
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
180686|NCT01448057|P2|Participant Flow|Paracetamol Tablets|"Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
217221|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
180693|NCT01448057|E1|Reported Event|Arm A|"Combination Product
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
180694|NCT01448044|B3|Baseline|Total|Total of all reporting groups
180695|NCT01448044|B2|Baseline|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
180696|NCT01448044|B1|Baseline|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
180697|NCT01448044|P2|Participant Flow|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
180698|NCT01448044|P1|Participant Flow|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
180699|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
180700|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
180701|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
180702|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
180703|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
180704|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
180705|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
180706|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
180707|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
180708|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
180709|NCT01448044|E2|Reported Event|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
181090|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
180710|NCT01448044|E1|Reported Event|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
180711|NCT01447927|B3|Baseline|Total|Total of all reporting groups
180712|NCT01447927|B2|Baseline|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
180713|NCT01447927|B1|Baseline|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
180714|NCT01447927|P2|Participant Flow|Placebo|Patients receive extended-release placebo orally (PO) once daily (QD) on week 1and BID on weeks 2-12 (every morning (QAM) and every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.
180715|NCT01447927|P1|Participant Flow|Metformin|Patients receive extended-release metformin hydrochloride orally (PO) once daily (QD) on week 1, and twice daily (BID) on weeks 2-12 (every morning (QAM) every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.
180716|NCT01447927|O2|Outcome|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
180717|NCT01447927|O1|Outcome|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
180718|NCT01447927|O2|Outcome|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
180719|NCT01447927|O1|Outcome|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
180720|NCT01447927|E2|Reported Event|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
180721|NCT01447927|E1|Reported Event|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
180722|NCT01447914|B1|Baseline|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
180723|NCT01447914|P1|Participant Flow|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
180724|NCT01447914|O1|Outcome|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
180725|NCT01447914|O1|Outcome|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
180726|NCT01447914|E1|Reported Event|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
180727|NCT01447849|B5|Baseline|Total|Total of all reporting groups
180728|NCT01447849|B4|Baseline|Controls on Placebo Then Lubiprostone|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
180729|NCT01447849|B3|Baseline|Controls on Lubiprostone Then Placebo|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
180730|NCT01447849|B2|Baseline|Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone|"Subjects with chronic constipation (CC)received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.
placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
180731|NCT01447849|B1|Baseline|Chronic Constipation(CC) Subjects on Lubiprostone Then Placebo|"Subjects with chronic constipation (CC) received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
180732|NCT01447849|P4|Participant Flow|Controls on Placebo Then Lubiprostone|"Control group received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.
placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
180733|NCT01447849|P3|Participant Flow|Controls on Lubiprostone Then Placebo|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
180734|NCT01447849|P2|Participant Flow|Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone|"Subjects with chronic constipation received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.
placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
180735|NCT01447849|P1|Participant Flow|Chronic Constipation (CC)Subjects on Lubiprostone Then Placebo|"Subjects with chronic constipation received 1 week of therapy with lubiprostone,then washed out for 1 week, then received 1 week of therapy with placebo.
lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
180736|NCT01447849|O2|Outcome|Placebo|Both controls and patients with chronic constipation received lubiprostone 24mcg twice daily for one week and placebo pills twice daily for one week in cross over design.
180737|NCT01447849|O1|Outcome|Lubiprostone 24 mcg Bid|Both controls and patients with chronic constipation received lubiprostone 24 mcg twice daily for one week and placebo pills twice daily for one week in cross over design.
180738|NCT01447849|O2|Outcome|Placebo|Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
181216|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
180739|NCT01447849|O1|Outcome|Lubiprostone 24 mcg BID|Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
180740|NCT01447849|E4|Reported Event|Controls on Placebo Then Lubiprostone|Control group who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone.
180741|NCT01447849|E3|Reported Event|Controls on Lubiprostone Then Placebo|Control group who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
180742|NCT01447849|E2|Reported Event|Chronic Constipation Subjects on Placebo Then Lubiprostone|Subjects with chronic constipation who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone.
180743|NCT01447849|E1|Reported Event|Chronic Constipation Subjects on Lubiprostone Then Placebo|Subjects with chronic constipation who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
180744|NCT01447719|B1|Baseline|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
180745|NCT01447719|P1|Participant Flow|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
180746|NCT01447719|O1|Outcome|Autopsy Within 1 Year of Scan|Group of subjects with valid images who came to autopsy within 1 year of scan
180747|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
180748|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
180749|NCT01447719|O1|Outcome|Subjects With no or Sparse Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 1 year of scan and had no or sparse neuritic plaques at autopsy (no AD or possible AD)
180750|NCT01447719|O1|Outcome|Subjects With Moderate or Frequent Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 1 years of scan and had moderate to frequent neuritic plaques at autopsy (probable AD or definite AD)
180751|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
180752|NCT01447719|O1|Outcome|Subjects With no or Sparse Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 2 years of scan and had no or sparse neuritic plaques at autopsy (no AD or possible AD)
180753|NCT01447719|O1|Outcome|Subjects With Moderate or Frequent Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 2 years of scan and had moderate to frequent neuritic plaques at autopsy (probable AD or definite AD)
180754|NCT01447719|E1|Reported Event|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
180755|NCT01447706|B3|Baseline|Total|Total of all reporting groups
180756|NCT01447706|B2|Baseline|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
180757|NCT01447706|B1|Baseline|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
180758|NCT01447706|P2|Participant Flow|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
180759|NCT01447706|P1|Participant Flow|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
180760|NCT01447706|O4|Outcome|HRG Low: MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
180761|NCT01447706|O3|Outcome|HRG Low: Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
180762|NCT01447706|O2|Outcome|HRG High: Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
180763|NCT01447706|O1|Outcome|HRG High: MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
180764|NCT01447706|O2|Outcome|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
180765|NCT01447706|O1|Outcome|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
180766|NCT01447706|O2|Outcome|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
180767|NCT01447706|O1|Outcome|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
180768|NCT01447706|E2|Reported Event|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
180769|NCT01447706|E1|Reported Event|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
180770|NCT01447576|B1|Baseline|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
180771|NCT01447576|P1|Participant Flow|Brexpiprazole +ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
180772|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
180773|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
180774|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
180775|NCT01447576|E1|Reported Event|Brexpiprazole+ADT|Participants received brexpiprazole 0.25 to 3.0mg/day plus ADT.
180776|NCT01447511|B6|Baseline|Total|Total of all reporting groups
180777|NCT01447511|B5|Baseline|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180778|NCT01447511|B4|Baseline|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
181091|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
180779|NCT01447511|B3|Baseline|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180780|NCT01447511|B2|Baseline|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
180781|NCT01447511|B1|Baseline|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180782|NCT01447511|P5|Participant Flow|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180783|NCT01447511|P4|Participant Flow|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180784|NCT01447511|P3|Participant Flow|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180785|NCT01447511|P2|Participant Flow|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
180786|NCT01447511|P1|Participant Flow|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180787|NCT01447511|O5|Outcome|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180788|NCT01447511|O4|Outcome|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180789|NCT01447511|O3|Outcome|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180790|NCT01447511|O2|Outcome|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
180791|NCT01447511|O1|Outcome|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180792|NCT01447511|E5|Reported Event|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180793|NCT01447511|E4|Reported Event|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180794|NCT01447511|E3|Reported Event|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180795|NCT01447511|E2|Reported Event|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
180796|NCT01447511|E1|Reported Event|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
180797|NCT01447446|B7|Baseline|Total|Total of all reporting groups
180798|NCT01447446|B6|Baseline|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180799|NCT01447446|B5|Baseline|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180800|NCT01447446|B4|Baseline|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180801|NCT01447446|B3|Baseline|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180802|NCT01447446|B2|Baseline|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180803|NCT01447446|B1|Baseline|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180804|NCT01447446|P6|Participant Flow|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180805|NCT01447446|P5|Participant Flow|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180871|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180806|NCT01447446|P4|Participant Flow|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180807|NCT01447446|P3|Participant Flow|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180808|NCT01447446|P2|Participant Flow|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180809|NCT01447446|P1|Participant Flow|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180810|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180811|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180812|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180813|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180814|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180815|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180816|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180817|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180818|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180819|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180820|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180821|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180822|NCT01447446|O4|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180823|NCT01447446|O3|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180824|NCT01447446|O2|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180825|NCT01447446|O1|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180826|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180951|NCT01447225|P8|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle
Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
180827|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180828|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180829|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180830|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180831|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180832|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180833|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180834|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180835|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180836|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180837|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180838|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180839|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180840|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180841|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180842|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180843|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180844|NCT01447446|O4|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180845|NCT01447446|O3|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180846|NCT01447446|O2|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180847|NCT01447446|O1|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180848|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
181081|NCT01446289|B2|Baseline|Mothers Placebo|Pregnant women who received one injection of saline solution.
180849|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180850|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180851|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180852|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180853|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180854|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180855|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180856|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180857|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180858|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180859|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180860|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180861|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180862|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180863|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180864|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180865|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180866|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180867|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180868|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180869|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180870|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
181082|NCT01446289|B1|Baseline|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
180872|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180873|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180874|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180875|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180876|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180877|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180878|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180879|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180880|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180881|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180882|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180883|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180884|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180885|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180886|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180887|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180888|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180889|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180890|NCT01447446|E6|Reported Event|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180891|NCT01447446|E5|Reported Event|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180892|NCT01447446|E4|Reported Event|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180893|NCT01447446|E3|Reported Event|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
181092|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
180894|NCT01447446|E2|Reported Event|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180895|NCT01447446|E1|Reported Event|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
180896|NCT01447433|B3|Baseline|Total|Total of all reporting groups
180897|NCT01447433|B2|Baseline|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180898|NCT01447433|B1|Baseline|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180899|NCT01447433|P2|Participant Flow|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180900|NCT01447433|P1|Participant Flow|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180901|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180902|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180903|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180904|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180905|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180906|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180907|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180908|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180909|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180910|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180911|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180912|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180913|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180914|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180915|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180916|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180917|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180918|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180919|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180920|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180921|NCT01447433|E2|Reported Event|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180922|NCT01447433|E1|Reported Event|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
180923|NCT01447420|B4|Baseline|Total|Total of all reporting groups
180924|NCT01447420|B3|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
180925|NCT01447420|B2|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered with peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
180926|NCT01447420|B1|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype – CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
180927|NCT01447420|P3|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
180928|NCT01447420|P2|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
181205|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
180929|NCT01447420|P1|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype – CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
180930|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
180931|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
180932|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
180933|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
180934|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
180935|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
180936|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
180937|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
180938|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
180939|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants were administered peginterferon alfa-2a 180 mcg SC weekly, 48 weeks and Ribavirin 1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg, orally daily, 48 weeks
180940|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
180941|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
180942|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
180943|NCT01447420|E1|Reported Event|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants were administered peginterferon alfa-2a, 180 mcg SC weekly, 48 weeks and Ribavirin 1000 mg per day for < 75 kg and 1200 mg per day for >= 75 kg, orally daily, 48 weeks.
180944|NCT01447225|B5|Baseline|Total|Total of all reporting groups
180945|NCT01447225|B4|Baseline|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
180946|NCT01447225|B3|Baseline|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
Pemetrexed: administered IV at 500 mg/m2"
180947|NCT01447225|B2|Baseline|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
Carboplatin: administered at AUC 6"
180948|NCT01447225|B1|Baseline|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV"
180949|NCT01447225|P10|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle
Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
180950|NCT01447225|P9|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle
Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
181206|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
180952|NCT01447225|P7|Participant Flow|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle
Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
180953|NCT01447225|P6|Participant Flow|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle
Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
180954|NCT01447225|P5|Participant Flow|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 5 Day 1 of every 3 week cycle"
180955|NCT01447225|P4|Participant Flow|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 5 Day 1 of every 3 week cycle"
180956|NCT01447225|P3|Participant Flow|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 6 Day 1 of every 3 week cycle"
180957|NCT01447225|P2|Participant Flow|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle
Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
180958|NCT01447225|P1|Participant Flow|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles
gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
180959|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle
Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
180960|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle
Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
180961|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle
Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
180962|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle
Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
180963|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle
Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
180964|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 5 Day 1 of every 3 week cycle"
180965|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 5 Day 1 of every 3 week cycle"
180966|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 6 Day 1 of every 3 week cycle"
180967|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle
Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
180968|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles
gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
180969|NCT01447225|O8|Outcome|MM-121 + Cisplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus Cisplatin 25 mg/m2
180970|NCT01447225|O7|Outcome|MM-121 + Pemetrexed: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
180971|NCT01447225|O6|Outcome|MM-121 + Carboplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus carboplatin AUC 6
180972|NCT01447225|O5|Outcome|MM-121 + Gemcitabine: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
180973|NCT01447225|O4|Outcome|MM-121 + Cisplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus Cisplatin 20 mg/m2 or 25 mg/m2
180974|NCT01447225|O3|Outcome|MM-121 + Pemetrexed: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
180975|NCT01447225|O2|Outcome|MM-121 + Carboplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus carboplatin AUC 6
180976|NCT01447225|O1|Outcome|MM-121 + Gemcitabine: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
180977|NCT01447225|O8|Outcome|MM-121 + Cisplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus Cisplatin 25 mg/m2
180978|NCT01447225|O7|Outcome|MM-121 + Pemetrexed: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
180979|NCT01447225|O6|Outcome|MM-121 + Carboplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus carboplatin AUC 6
180980|NCT01447225|O5|Outcome|MM-121 + Gemcitabine: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
180981|NCT01447225|O4|Outcome|MM-121 + Cisplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus Cisplatin 20 mg/m2 or 25 mg/m2
180982|NCT01447225|O3|Outcome|MM-121 + Pemetrexed: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
180983|NCT01447225|O2|Outcome|MM-121 + Carboplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus carboplatin AUC 6
180984|NCT01447225|O1|Outcome|MM-121 + Gemcitabine: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
217222|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
180985|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle
Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
180986|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle
Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
180987|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle
Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
180988|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle
Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
180989|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle
Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
180990|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 5 Day 1 of every 3 week cycle"
180991|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 5 Day 1 of every 3 week cycle"
180992|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 6 Day 1 of every 3 week cycle"
180993|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle
Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
180994|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles
gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
180995|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle
Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
180996|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle
Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
180997|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle
Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
180998|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle
Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
180999|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle
Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
181000|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 5 Day 1 of every 3 week cycle"
181001|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 5 Day 1 of every 3 week cycle"
181002|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 6 Day 1 of every 3 week cycle"
181003|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle
Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
181004|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles
gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
181005|NCT01447225|O1|Outcome|MM-121 + Cabazitaxel|MTD of MM-121 + Cabazitaxel combination - NOTE: MTD of MM-121 for this combination provided in separate endpoint
181006|NCT01447225|O1|Outcome|MM-121 + Pemetrexed|MTD of combination of MM-121 + Pemetrexed - NOTE: MTD of MM-121 for this combination provided in separate endpoint
181007|NCT01447225|O1|Outcome|MM-121 + Carboplatin|MTD of the MM-121 + Carboplatin combination NOTE: MTD of MM-121 for this combination provided in separate endpoint
181008|NCT01447225|O1|Outcome|MM-121 + Gemcitabine|
181009|NCT01447225|O4|Outcome|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
181010|NCT01447225|O3|Outcome|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
Pemetrexed: administered IV at 500 mg/m2"
181011|NCT01447225|O2|Outcome|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
Carboplatin: administered at AUC 6"
181012|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
Gemcitabine: administered IV at 1000 mg/m2 or 1250 mg/m2"
181013|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle
Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
217223|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
181014|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle
Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
181015|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle
Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
181016|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle
Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
181017|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle
Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
181018|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 5 Day 1 of every 3 week cycle"
181019|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 5 Day 1 of every 3 week cycle"
181020|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle
Carboplatin at AUC 6 Day 1 of every 3 week cycle"
181021|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle
Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
181022|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles
gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
181023|NCT01447225|E4|Reported Event|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
181024|NCT01447225|E3|Reported Event|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
Pemetrexed: administered IV at 500 mg/m2"
181025|NCT01447225|E2|Reported Event|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
Carboplatin: administered at AUC 6"
181026|NCT01447225|E1|Reported Event|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle
MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV"
181027|NCT01447121|B1|Baseline|Intended Users of the System|Study results from 2 subjects were excluded from all data analysis, because study staff inadvertently performed study tasks that could be considered 'training' them. (According to protocol, training was not allowed.)
181028|NCT01447121|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.
Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
181029|NCT01447121|O1|Outcome|Study Staff|Study staff also used the investigational Blood Glucose Monitoring System (BGMS) (Tatus/Tradewind Investigational Blood Glucose Meter)
181030|NCT01447121|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.
Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
181031|NCT01447121|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.
Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
181032|NCT01447017|B3|Baseline|Total|Total of all reporting groups
181033|NCT01447017|B2|Baseline|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
181034|NCT01447017|B1|Baseline|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
181035|NCT01447017|P2|Participant Flow|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
181036|NCT01447017|P1|Participant Flow|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
181037|NCT01447017|O2|Outcome|Placebo for DPK-060 Ear Drops|Patients randomized to treatment with Placebo for DPK-060 ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
181038|NCT01447017|O1|Outcome|DPK-060 2% Ear Drops|Patients randomized to treatment with DPK-060 2% ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
181039|NCT01447017|E2|Reported Event|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
181040|NCT01447017|E1|Reported Event|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
181041|NCT01446796|B1|Baseline|Continuous RV Pacing|Study terminated early due to recruitment
181042|NCT01446796|P2|Participant Flow|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
181043|NCT01446796|P1|Participant Flow|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
217224|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
181044|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
181045|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
181046|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
181047|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
181048|NCT01446796|O2|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
181049|NCT01446796|O1|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
181050|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
181051|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
181052|NCT01446796|E2|Reported Event|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
181053|NCT01446796|E1|Reported Event|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
181054|NCT01446705|B3|Baseline|Total|Total of all reporting groups
181055|NCT01446705|B2|Baseline|Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
181056|NCT01446705|B1|Baseline|Control (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has not been activated.
181057|NCT01446705|P2|Participant Flow|Patients Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
181058|NCT01446705|P1|Participant Flow|Controls (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VA Medical Center (VAMC) for whom information exchange has not been activated.
181059|NCT01446705|O2|Outcome|Enrolled in HIE|Patients in this arm represent Veterans seen at the Indianapolis VAMC enrolled in VLER who have readily identifiable cost information. The analysis will determine any difference among baseline variables
181060|NCT01446705|O1|Outcome|Control (Not Enrolled)|Patients in this arm represent Veterans seen at the Indianapolis VAMC NOT enrolled in VLER who have readily identifiable cost information. The analysis will determine any difference among baseline variables
181061|NCT01446705|O2|Outcome|Enrolled in HIE|This group represents veterans were enrolled in Health Information Exchange via VLER
181062|NCT01446705|O1|Outcome|Control (Not Enrolled)|Patients in this group were not enrolled in Health Information Exchange.
181063|NCT01446705|E2|Reported Event|Patients Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
181064|NCT01446705|E1|Reported Event|Controls (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has not been activated.
181065|NCT01446419|B3|Baseline|Total|Total of all reporting groups
181066|NCT01446419|B2|Baseline|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
181067|NCT01446419|B1|Baseline|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
181068|NCT01446419|P2|Participant Flow|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
181069|NCT01446419|P1|Participant Flow|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
181070|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
181071|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
181072|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
181073|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
181074|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
181075|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
181076|NCT01446419|E2|Reported Event|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
181077|NCT01446419|E1|Reported Event|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
181078|NCT01446289|B5|Baseline|Total|Total of all reporting groups
181079|NCT01446289|B4|Baseline|Infants Placebo|Infants born from mothers who received one injection of saline solution.
181080|NCT01446289|B3|Baseline|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
217225|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
181093|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
181094|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
181095|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
181096|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
181097|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
181098|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
181099|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
181100|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
181101|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
181102|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
181103|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
181104|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
181105|NCT01446289|O4|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
181106|NCT01446289|O3|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
181107|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
181108|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
181109|NCT01446289|E4|Reported Event|Infants Placebo|Infants born from mothers who received one injection of saline solution.
181110|NCT01446289|E3|Reported Event|Infants GBS|Infants born from mothers who received one dose of GBS vaccine.
181111|NCT01446289|E2|Reported Event|Mothers Placebo|Pregnant women who received one injection of saline solution.
181112|NCT01446289|E1|Reported Event|Mothers GBS|Pregnant women who received one dose of GBS vaccine.
181113|NCT01446250|B1|Baseline|All Enrolled Participants|Analysis was performed on all enrolled participants.
181114|NCT01446250|P4|Participant Flow|No Intervention|Participants who had an End of Treatment Response (ETR) were followed-up for 24 weeks after the last dose of BOC triple therapy (in Treatment Period 2) and participants who did not respond for any reason or discontinued the treatment early were followed-up for 12 weeks after the last dose of BOC (in Treatment Period 2).
181115|NCT01446250|P3|Participant Flow|PEGinf + RBV|Participants who received ALV in Treatment Period 1 were put on clinical hold but continued receiving PEGinf and RBV for 4 weeks, after which they switched to BOC triple therapy in Treatment Period 2.
181116|NCT01446250|P2|Participant Flow|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
181117|NCT01446250|P1|Participant Flow|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
181118|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
181119|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
181120|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
181121|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
181122|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
181123|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
181124|NCT01446250|E4|Reported Event|No Intervention|AE was discovered while taking no intervention.
181125|NCT01446250|E3|Reported Event|PEGinf + RBV|AE occurred while taking only PEGinf + RBV.
181126|NCT01446250|E2|Reported Event|Boceprevir|AE occurred while taking Boceprevir + PEGinf + RBV.
181127|NCT01446250|E1|Reported Event|Alisporivir|Adverse event (AE) occurred while taking Alisporivir + PEGinf + RBV.
181128|NCT01446237|B1|Baseline|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
181129|NCT01446237|P1|Participant Flow|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (Benzoyl Peroxide[BPO]) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 percent salicylic acid [SA]) each evening over an application period of 12 weeks.
181130|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
181207|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181131|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
181132|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
181133|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
181134|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
181135|NCT01446237|E1|Reported Event|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
181136|NCT01446003|B1|Baseline|All Participants|
181137|NCT01446003|P2|Participant Flow|Placebo-MK-8457 Sequence|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
181138|NCT01446003|P1|Participant Flow|MK-8457-Placebo Sequence|Participants received MK-8457 100 mg twice daily (BID) for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
181139|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
181140|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
181141|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
181142|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
181143|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
181144|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
181145|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
181146|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
181147|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
181148|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
181149|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
181150|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
181151|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
181152|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
181153|NCT01446003|E2|Reported Event|Placebo|Participants received Placebo for MK-8457 for 10 days
181154|NCT01446003|E1|Reported Event|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
181155|NCT01445951|B4|Baseline|Total|Total of all reporting groups
181156|NCT01445951|B3|Baseline|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181157|NCT01445951|B2|Baseline|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181158|NCT01445951|B1|Baseline|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181159|NCT01445951|P3|Participant Flow|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181160|NCT01445951|P2|Participant Flow|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181161|NCT01445951|P1|Participant Flow|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181162|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181163|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181164|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181165|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181166|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181167|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181168|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181169|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181170|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181171|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181172|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181173|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181174|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181175|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181176|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181177|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181178|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181179|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181180|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181181|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181182|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181183|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181184|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181185|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181186|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181187|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181188|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181189|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181190|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181191|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181192|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
181193|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181194|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
181195|NCT01445951|E3|Reported Event|Aspart Group|"Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry
Insulin Aspart in combination with a basal insulin: Injectable insulin"
181196|NCT01445951|E2|Reported Event|Technosphere® Insulin With MedTone C Inhaler|"Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry
Technosphere® Insulin with MedTone C Inhaler: Inhalation Powder and injectable insulin"
181197|NCT01445951|E1|Reported Event|Technosphere ® Insulin-Gen2 Group|"Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry
Technosphere ®Insulin with Gen2 Inhaler: Inhalation Powder and injectable insulin"
181198|NCT01445873|B1|Baseline|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181199|NCT01445873|P1|Participant Flow|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181200|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181201|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181202|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181203|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181204|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181217|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181218|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181219|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181220|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181221|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181222|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181223|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181224|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181225|NCT01445873|E1|Reported Event|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
181226|NCT01445847|B3|Baseline|Total|Total of all reporting groups
181227|NCT01445847|B2|Baseline|Placebo|Placebo group received 1 mL/10 kg bolus once inhalational gas (Desflurane) is discontinued
181228|NCT01445847|B1|Baseline|Lidocaine|Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
181229|NCT01445847|P2|Participant Flow|Placebo|Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
181230|NCT01445847|P1|Participant Flow|Lidocaine|Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
181231|NCT01445847|O2|Outcome|Placebo|Placebo group received 1 ml per 10 kg (0.2 mL per 2 kg) bolus once inhalational gas (Desflurane) is discontinued
181232|NCT01445847|O1|Outcome|Lidocaine|Lidocaine group received 1 mg per kg (1mL per 10kg) bolus once inhalational gas (Desflurane) is discontinued
181233|NCT01445847|E2|Reported Event|Placebo|Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
181234|NCT01445847|E1|Reported Event|Lidocaine|Lidocaine group received 1 ml/10 kg (or 1mg/kg) bolus once inhalational gas (Desflurane) is discontinued
181235|NCT01445769|B1|Baseline|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥ 100 x 10^9/L at week 12 or ≥ 150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181236|NCT01445769|P1|Participant Flow|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported Patients' Global Impression of Change (PGIC) score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181237|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥ 100 x 10^9/L at week 12 or ≥ 150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181238|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181239|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181240|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181241|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181292|NCT01445626|E1|Reported Event|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
181704|NCT01443845|E2|Reported Event|Roflumilast|Roflumilast 500 µg, oral administration, once per day
181242|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181243|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181244|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181245|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181246|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181247|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181248|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181249|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181250|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia. Only the subjects who had Week 24 spleen volume data are summarized.
181251|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia. Only the subjects who had Week 24 spleen volume data are summarized.
181293|NCT01445613|B1|Baseline|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
181398|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
181252|NCT01445769|E1|Reported Event|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
181253|NCT01445678|B3|Baseline|Total|Total of all reporting groups
181254|NCT01445678|B2|Baseline|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
181255|NCT01445678|B1|Baseline|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
181256|NCT01445678|P2|Participant Flow|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days Of the 979 treated subjects in the integrated analysis set, 497 received meropenem.
181257|NCT01445678|P1|Participant Flow|CXA-201 and Metronidazole as Treatment for cIAI|"CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days.
Of the 979 treated subjects in the integrated analysis set, 482 received CXA."
181258|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
181259|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
181260|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
181261|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
181262|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
181263|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
181264|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
181265|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
181266|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
181267|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
181268|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
181269|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
181270|NCT01445678|E2|Reported Event|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
181271|NCT01445678|E1|Reported Event|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
181272|NCT01445652|B3|Baseline|Total|Total of all reporting groups
181273|NCT01445652|B2|Baseline|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
181274|NCT01445652|B1|Baseline|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
181275|NCT01445652|P2|Participant Flow|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
181276|NCT01445652|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
181277|NCT01445652|O2|Outcome|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
181278|NCT01445652|O1|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
181279|NCT01445652|O2|Outcome|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
181280|NCT01445652|O1|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
181281|NCT01445652|E2|Reported Event|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
181282|NCT01445652|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
181283|NCT01445626|B1|Baseline|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
181284|NCT01445626|P1|Participant Flow|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
181285|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
181286|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
181287|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
181288|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
181289|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
181290|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
181291|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
217226|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
181294|NCT01445613|P1|Participant Flow|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
181295|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
181296|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
181297|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
181298|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
181299|NCT01445613|O2|Outcome|In Non-octogenarian Group|Non-octogenarian: A person who is less than 80 years old.
181300|NCT01445613|O1|Outcome|In Octogenarian Group|Octogenarian: A person with age >= 80 years.
181301|NCT01445613|O2|Outcome|In Non-octogenarian Group|Non-octogenarian: A person who is less than 80 years old.
181302|NCT01445613|O1|Outcome|In Octogenarian Group|Octogenarian: A person with age >= 80 years.
181303|NCT01445613|O2|Outcome|In Asymptomatic Group|Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
181304|NCT01445613|O1|Outcome|In Symptomatic Group|Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or TIA (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.
181305|NCT01445613|O2|Outcome|Composite of Peri-procedural DS in the Asymptomatic Group|Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
181306|NCT01445613|O1|Outcome|Composite of Peri-procedural DS in the Symptomatic Group|Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or transient ischemic attack (TIA) (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.
181307|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
181308|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
181309|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
181310|NCT01445613|E1|Reported Event|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
181311|NCT01445548|B1|Baseline|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181312|NCT01445548|P1|Participant Flow|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181313|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181314|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181315|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181316|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181317|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181696|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
181318|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181319|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181320|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181321|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181322|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181323|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181324|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181325|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181326|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181327|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181328|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181329|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181330|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181331|NCT01445548|E1|Reported Event|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.
As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
181332|NCT01445028|B3|Baseline|Total|Total of all reporting groups
181333|NCT01445028|B2|Baseline|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
181334|NCT01445028|B1|Baseline|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
181335|NCT01445028|P2|Participant Flow|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
181336|NCT01445028|P1|Participant Flow|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
181337|NCT01445028|O2|Outcome|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
181338|NCT01445028|O1|Outcome|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
181339|NCT01445028|E2|Reported Event|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
181340|NCT01445028|E1|Reported Event|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
181341|NCT01444924|B3|Baseline|Total|Total of all reporting groups
181342|NCT01444924|B2|Baseline|Placebo|"TAP block with placebo placed prior to surgery
Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
181343|NCT01444924|B1|Baseline|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.
Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
181344|NCT01444924|P2|Participant Flow|Placebo|"TAP block with placebo placed prior to surgery
Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
181397|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181697|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
181345|NCT01444924|P1|Participant Flow|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.
Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
181346|NCT01444924|O2|Outcome|Placebo|"TAP block with placebo placed prior to surgery
Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
181347|NCT01444924|O1|Outcome|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.
Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
181348|NCT01444924|E2|Reported Event|Placebo|"TAP block with placebo placed prior to surgery
Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
181349|NCT01444924|E1|Reported Event|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.
Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
181350|NCT01444911|B3|Baseline|Total|Total of all reporting groups
181351|NCT01444911|B2|Baseline|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.
Vaginal Dilator: Still vaginal dilator with lubricant."
181352|NCT01444911|B1|Baseline|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
181353|NCT01444911|P2|Participant Flow|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.
Vaginal Dilator: Still vaginal dilator with lubricant."
181354|NCT01444911|P1|Participant Flow|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
181355|NCT01444911|O2|Outcome|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.
Vaginal Dilator: Still vaginal dilator with lubricant."
181356|NCT01444911|O1|Outcome|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
181357|NCT01444911|O2|Outcome|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.
Vaginal Dilator: Still vaginal dilator with lubricant."
181358|NCT01444911|O1|Outcome|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
181359|NCT01444911|O2|Outcome|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.
Vaginal Dilator: Still vaginal dilator with lubricant."
181360|NCT01444911|O1|Outcome|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
181361|NCT01444911|O2|Outcome|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.
Vaginal Dilator: Still vaginal dilator with lubricant."
181362|NCT01444911|O1|Outcome|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
181363|NCT01444911|E2|Reported Event|Standard of Care|"This will consist of still vaginal dilator and/or lubricant.
Vaginal Dilator: Still vaginal dilator with lubricant."
181364|NCT01444911|E1|Reported Event|Vaginal Renewal Program|Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
181365|NCT01444898|B1|Baseline|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.
Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
181366|NCT01444898|P1|Participant Flow|Exenatide|All subjects enrolled in this study will be given Exenatide for 6 months. The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months).
181367|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.
Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
181368|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.
Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
181369|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.
Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
181370|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.
Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
181371|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.
Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
181372|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.
Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
181373|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.
Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
181374|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.
Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
181375|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.
Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
181376|NCT01444898|E1|Reported Event|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.
Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
181377|NCT01444781|B4|Baseline|Total|Total of all reporting groups
181378|NCT01444781|B3|Baseline|Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster Group.|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
181379|NCT01444781|B2|Baseline|DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181380|NCT01444781|B1|Baseline|DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
181381|NCT01444781|P3|Participant Flow|Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
181382|NCT01444781|P2|Participant Flow|Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181383|NCT01444781|P1|Participant Flow|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
181384|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
181385|NCT01444781|O2|Outcome|Group 2: DTaP-IPV-HepB-PRP~Tprimary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181386|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~ T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
181387|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
181388|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181389|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
181390|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
181391|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181392|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
181393|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
181394|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181395|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
181396|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
181698|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
181399|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
181400|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181401|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
181402|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
181403|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181404|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
181405|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
181406|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181407|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
181408|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
181409|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181410|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
181411|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
181412|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181413|NCT01444781|O1|Outcome|Group 1: DTaP-IPV Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
181414|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
181415|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181416|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
181417|NCT01444781|E3|Reported Event|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
181418|NCT01444781|E2|Reported Event|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
181419|NCT01444781|E1|Reported Event|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
181420|NCT01444651|B3|Baseline|Total|Total of all reporting groups
181421|NCT01444651|B2|Baseline|Placebo|"Placebo tablet taken by mouth once a day for 3 months
Placebo: Placebo tablet taken by mouth once a day for 3 months"
181422|NCT01444651|B1|Baseline|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months
Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
181423|NCT01444651|P2|Participant Flow|Placebo|"Placebo tablet taken by mouth once a day for 3 months
Placebo: Placebo tablet taken by mouth once a day for 3 months"
181424|NCT01444651|P1|Participant Flow|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months
Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
181425|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months
Placebo: Placebo tablet taken by mouth once a day for 3 months"
181426|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months
Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
181427|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months
Placebo: Placebo tablet taken by mouth once a day for 3 months"
181428|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months
Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
181429|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months
Placebo: Placebo tablet taken by mouth once a day for 3 months"
181430|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months
Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
181431|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months
Placebo: Placebo tablet taken by mouth once a day for 3 months"
181432|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months
Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
181433|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months
Placebo: Placebo tablet taken by mouth once a day for 3 months"
181434|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months
Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
181435|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months
Placebo: Placebo tablet taken by mouth once a day for 3 months"
181436|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months
Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
181437|NCT01444651|E2|Reported Event|Placebo|"Placebo tablet taken by mouth once a day for 3 months
Placebo: Placebo tablet taken by mouth once a day for 3 months"
181438|NCT01444651|E1|Reported Event|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months
Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
181439|NCT01444456|B1|Baseline|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
181440|NCT01444456|P1|Participant Flow|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
181441|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
181442|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
181443|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
181444|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
181445|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
181446|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
181447|NCT01444456|E1|Reported Event|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
181448|NCT01444430|B3|Baseline|Total|Total of all reporting groups
181449|NCT01444430|B2|Baseline|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
181450|NCT01444430|B1|Baseline|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
181451|NCT01444430|P2|Participant Flow|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
181452|NCT01444430|P1|Participant Flow|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
181453|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
181454|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
181455|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
181456|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
181457|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
181458|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
181459|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
181460|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
181461|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
181462|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
181463|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
181464|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
181465|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
181466|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
181467|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
181468|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
181469|NCT01444430|E2|Reported Event|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
181470|NCT01444430|E1|Reported Event|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
181471|NCT01444417|B3|Baseline|Total|Total of all reporting groups
181472|NCT01444417|B2|Baseline|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
181473|NCT01444417|B1|Baseline|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
181474|NCT01444417|P2|Participant Flow|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
181475|NCT01444417|P1|Participant Flow|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
181476|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
181477|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
181478|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
181479|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
181480|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
181481|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
181482|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
181483|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
181484|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
181485|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
181486|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
181487|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
181488|NCT01444417|E2|Reported Event|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
181489|NCT01444417|E1|Reported Event|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
181490|NCT01444391|B1|Baseline|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
181491|NCT01444391|P1|Participant Flow|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
181492|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
181493|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
181494|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
181495|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
181496|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
181497|NCT01444391|E1|Reported Event|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
181498|NCT01444378|B1|Baseline|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181499|NCT01444378|P1|Participant Flow|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181500|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181501|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181502|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181503|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181504|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181505|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181506|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181507|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181508|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181509|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181510|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181511|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181512|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181513|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181514|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181515|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181516|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181517|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181518|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181519|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181520|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181521|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181522|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181523|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181524|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181525|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181526|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181527|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181528|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181529|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181530|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181531|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181532|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181533|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181534|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181535|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181536|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181537|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181538|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181539|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181540|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181541|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181542|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181543|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181544|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181545|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181546|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181547|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181548|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181549|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181550|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181551|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181552|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181553|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181554|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181555|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181556|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181557|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181558|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181559|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181560|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181561|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181562|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181563|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181564|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181565|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181566|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181567|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181568|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181569|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181570|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181571|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181572|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181573|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181699|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
181574|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181575|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181576|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181577|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181578|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181579|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181580|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181581|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181582|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181583|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181584|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181585|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181586|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181587|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181588|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181589|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181590|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181591|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181592|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181593|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181594|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181595|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181596|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181597|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181598|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181599|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181600|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181601|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181602|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181603|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181604|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181605|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181606|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181607|NCT01444378|E1|Reported Event|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
181608|NCT01444300|B3|Baseline|Total|Total of all reporting groups
181609|NCT01444300|B2|Baseline|Placebo|Placebo: placebo pill, twice daily (bid), for 12 weeks
181610|NCT01444300|B1|Baseline|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
181611|NCT01444300|P2|Participant Flow|Placebo|Placebo: placebo pill, twice daily, for 12 weeks
181612|NCT01444300|P1|Participant Flow|Dalfampridine|Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
181613|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for for 12 weeks
181614|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
181615|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
181616|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
181617|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
181618|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
181619|NCT01444300|E2|Reported Event|Placebo|Placebo: placebo pill, twice daily, for 12 weeks
181620|NCT01444300|E1|Reported Event|Dalfampridine|Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
181621|NCT01444287|B1|Baseline|All Subjects|Subjects who were enrolled and randomized to a trial arm.
181622|NCT01444287|P1|Participant Flow|All Study Participants|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. The four arms were Spectacles (no contact lenses), Narafilcon B, Polymacon A, and Lotrafilcon A, in random order during the sessions.
181623|NCT01444287|O4|Outcome|Lotrafilcon A (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181624|NCT01444287|O3|Outcome|Polymacon (+ Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181625|NCT01444287|O2|Outcome|Narafilcon B (Test)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181626|NCT01444287|O1|Outcome|Spectacles No Lenses (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181627|NCT01444287|O4|Outcome|Lotrafilcon A (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181628|NCT01444287|O3|Outcome|Polymacon (+ Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181629|NCT01444287|O2|Outcome|Narafilcon B (Test)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181630|NCT01444287|O1|Outcome|Spectacles No Lenses (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181631|NCT01444287|O4|Outcome|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181632|NCT01444287|O3|Outcome|Polymacon|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181633|NCT01444287|O2|Outcome|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181634|NCT01444287|O1|Outcome|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181635|NCT01444287|O4|Outcome|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181636|NCT01444287|O3|Outcome|Polymacon|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181637|NCT01444287|O2|Outcome|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181638|NCT01444287|O1|Outcome|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181639|NCT01444287|E4|Reported Event|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181640|NCT01444287|E3|Reported Event|Polymacon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181700|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
181641|NCT01444287|E2|Reported Event|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181642|NCT01444287|E1|Reported Event|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
181643|NCT01444092|B1|Baseline|Entocort|Entocort™ EC 9/6/3 mg
181644|NCT01444092|P1|Participant Flow|Entocort|Entocort™ EC 9/6/3 mg
181645|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
181646|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
181647|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
181648|NCT01444092|E1|Reported Event|Entocort|Entocort™ EC 9/6/3 mg
181649|NCT01443923|B3|Baseline|Total|Total of all reporting groups
181650|NCT01443923|B2|Baseline|2 HCV/HIV|"Hepatitis C and HIV co-Infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181651|NCT01443923|B1|Baseline|1-HCV|"Hepatitis C Mono-infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181652|NCT01443923|P2|Participant Flow|2 HCV/HIV|"Hepatitis C and HIV co-Infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181653|NCT01443923|P1|Participant Flow|1-HCV|"Hepatitis C Mono-infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181654|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181655|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181656|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181657|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181658|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181659|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181660|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181661|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181662|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181663|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181664|NCT01443923|E2|Reported Event|2 HCV/HIV|"Hepatitis C and HIV co-Infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181665|NCT01443923|E1|Reported Event|1-HCV|"Hepatitis C Mono-infected
Boceprevir
Peg-Interferon-alfa 2B
Ribavirin"
181666|NCT01443858|B4|Baseline|Total|Total of all reporting groups
181667|NCT01443858|B3|Baseline|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181668|NCT01443858|B2|Baseline|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181669|NCT01443858|B1|Baseline|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181670|NCT01443858|P3|Participant Flow|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181671|NCT01443858|P2|Participant Flow|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181701|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
181702|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
181703|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
181672|NCT01443858|P1|Participant Flow|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181673|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181674|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181675|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181676|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181677|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181678|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181679|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181680|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181681|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181682|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181683|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181684|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181685|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181686|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181687|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181688|NCT01443858|E3|Reported Event|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181689|NCT01443858|E2|Reported Event|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181690|NCT01443858|E1|Reported Event|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
181691|NCT01443845|B3|Baseline|Total|Total of all reporting groups
181692|NCT01443845|B2|Baseline|Roflumilast|Roflumilast 500 µg, oral administration, once per day
181693|NCT01443845|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
181694|NCT01443845|P2|Participant Flow|Roflumilast|Roflumilast 500 µg, oral administration, once per day
181695|NCT01443845|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
181705|NCT01443845|E1|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
181706|NCT01443494|B1|Baseline|Septic Shock Patients Despite EGDT With Hypertension|Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
181707|NCT01443494|P1|Participant Flow|Septic Shock Patients Despite EGDT With Hypertension|Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
181708|NCT01443494|O1|Outcome|Septic Shock Patients Despite EGDT|After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.
181709|NCT01443494|O1|Outcome|Septic Shock Patients Despite EGDT|After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.
181710|NCT01443494|E1|Reported Event|Septic Shock Patients Despite EGDT|Patients requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
181711|NCT01443403|B5|Baseline|Total|Total of all reporting groups
181712|NCT01443403|B4|Baseline|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181713|NCT01443403|B3|Baseline|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181714|NCT01443403|B2|Baseline|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181715|NCT01443403|B1|Baseline|Placebo|Participants received placebo orally once daily for 28 days.
181716|NCT01443403|P4|Participant Flow|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181717|NCT01443403|P3|Participant Flow|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181718|NCT01443403|P2|Participant Flow|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181719|NCT01443403|P1|Participant Flow|Placebo|Participants received placebo orally once daily for 28 days.
181720|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181721|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181722|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181723|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181724|NCT01443403|O3|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181725|NCT01443403|O2|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181726|NCT01443403|O1|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181727|NCT01443403|O3|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181728|NCT01443403|O2|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181729|NCT01443403|O1|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181730|NCT01443403|O3|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181731|NCT01443403|O2|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181732|NCT01443403|O1|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181733|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181734|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181735|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181736|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181737|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181738|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181739|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181740|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181741|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181742|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181743|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181744|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181745|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181746|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181747|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181748|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181749|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181750|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181751|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181752|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181753|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181754|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181755|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181756|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181757|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181758|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181759|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181760|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181761|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181762|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181763|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181764|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181765|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181766|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181767|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181768|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181769|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181770|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181771|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181772|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181773|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181774|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181775|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181776|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181777|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181778|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181779|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181780|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181781|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181782|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181783|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181784|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181785|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181786|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181787|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181788|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181789|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181790|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181791|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181792|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181793|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181794|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181795|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181796|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181797|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181798|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181799|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181800|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181801|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181802|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181803|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181804|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181805|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181806|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181807|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181808|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181809|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181810|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181811|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181812|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181813|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181814|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181815|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181816|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181817|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181818|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181819|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181820|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181821|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181822|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181823|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181824|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181825|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181826|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181827|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181828|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181829|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181830|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181831|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181832|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181833|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181834|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181835|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181836|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181837|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181838|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181839|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181840|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181841|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181842|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181843|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181844|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181845|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181846|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181847|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181848|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181849|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181850|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181851|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181852|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181853|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181854|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181855|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181856|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181857|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181858|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181859|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181860|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
181861|NCT01443403|E4|Reported Event|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
181862|NCT01443403|E3|Reported Event|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
181863|NCT01443403|E2|Reported Event|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
181864|NCT01443403|E1|Reported Event|Placebo|Participants received placebo orally once daily for 28 days.
181865|NCT01443364|B1|Baseline|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
182020|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
182021|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
181866|NCT01443364|P1|Participant Flow|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181867|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181868|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181869|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181870|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181871|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181872|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181873|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181874|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181875|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181876|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181877|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181878|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181879|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181880|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181881|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181882|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181883|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181884|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181885|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
182052|NCT01443078|E1|Reported Event|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
181886|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181887|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181888|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181889|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181890|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181891|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181892|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181893|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181894|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181895|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181896|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181897|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181898|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181899|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181900|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181901|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181902|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181903|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181904|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181905|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
182053|NCT01443026|B3|Baseline|Total|Total of all reporting groups
182054|NCT01443026|B2|Baseline|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
181906|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181907|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181908|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181909|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181910|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181911|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181912|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181913|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181914|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181915|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181916|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181917|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181918|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181919|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181920|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181921|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181922|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181923|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181924|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181925|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
182055|NCT01443026|B1|Baseline|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
181926|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181927|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181928|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181929|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181930|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181931|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181932|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181933|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181934|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181935|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181936|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181937|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181938|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181939|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181940|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181941|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181942|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181943|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181944|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181945|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
182083|NCT01442688|O1|Outcome|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
181946|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181947|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181948|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181949|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181950|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181951|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181952|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181953|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181954|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181955|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181956|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181957|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181958|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181959|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181960|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181961|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181962|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181963|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181964|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181965|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
182118|NCT01442181|P1|Participant Flow|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
181966|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181967|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181968|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181969|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181970|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181971|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181972|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181973|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181974|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181975|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181976|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181977|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181978|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181979|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181980|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181981|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181982|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181983|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181984|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181985|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
182119|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
217227|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
181986|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181987|NCT01443364|E1|Reported Event|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
181988|NCT01443130|B7|Baseline|Total|Total of all reporting groups
181989|NCT01443130|B6|Baseline|Infant SP IPT|Infants born to maternal participants who received SP IPT.
181990|NCT01443130|B5|Baseline|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
181991|NCT01443130|B4|Baseline|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
181992|NCT01443130|B3|Baseline|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
181993|NCT01443130|B2|Baseline|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
181994|NCT01443130|B1|Baseline|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
181995|NCT01443130|P6|Participant Flow|Infant SP IPT|Infants born to maternal participants who received SP IPT.
181996|NCT01443130|P5|Participant Flow|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
181997|NCT01443130|P4|Participant Flow|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
181998|NCT01443130|P3|Participant Flow|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
181999|NCT01443130|P2|Participant Flow|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182000|NCT01443130|P1|Participant Flow|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182001|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182002|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182003|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182004|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182005|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182006|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182007|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182008|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182009|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182010|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182011|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182012|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182013|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
182014|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
182015|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
182016|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
182017|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
182018|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
182019|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
182022|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182023|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182024|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182025|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182026|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182027|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182028|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182029|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182030|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182031|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182032|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182033|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182034|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182035|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182036|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182037|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182038|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182039|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182040|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182041|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182042|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182043|NCT01443130|E6|Reported Event|Infant SP IPT|Infants born to maternal participants who received SP IPT.
182044|NCT01443130|E5|Reported Event|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
182045|NCT01443130|E4|Reported Event|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
182046|NCT01443130|E3|Reported Event|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182047|NCT01443130|E2|Reported Event|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
182048|NCT01443130|E1|Reported Event|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
182049|NCT01443078|B1|Baseline|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
182050|NCT01443078|P1|Participant Flow|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
182051|NCT01443078|O1|Outcome|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
217228|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
182056|NCT01443026|P2|Participant Flow|Placebo|"Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)"
182057|NCT01443026|P1|Participant Flow|Lycopene|"Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)"
182058|NCT01443026|O2|Outcome|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
182059|NCT01443026|O1|Outcome|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
182060|NCT01443026|E2|Reported Event|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
182061|NCT01443026|E1|Reported Event|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
182062|NCT01442844|B3|Baseline|Total|Total of all reporting groups
182063|NCT01442844|B2|Baseline|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
182064|NCT01442844|B1|Baseline|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.
Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
182065|NCT01442844|P2|Participant Flow|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
182066|NCT01442844|P1|Participant Flow|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.
Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
182067|NCT01442844|O2|Outcome|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
182068|NCT01442844|O1|Outcome|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.
Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
182069|NCT01442844|E2|Reported Event|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
182070|NCT01442844|E1|Reported Event|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.
Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
182071|NCT01442779|B1|Baseline|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
182072|NCT01442779|P1|Participant Flow|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
182073|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
182074|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
182075|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
182076|NCT01442779|E1|Reported Event|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
182077|NCT01442688|B3|Baseline|Total|Total of all reporting groups
182078|NCT01442688|B2|Baseline|Amoxicillin + MMX Mesalazine/Mesalamine First|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
182079|NCT01442688|B1|Baseline|Amoxicillin + MMX Placebo First|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
182080|NCT01442688|P2|Participant Flow|Amoxicillin + MMX Mesalazine/Mesalamine First|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
182081|NCT01442688|P1|Participant Flow|Amoxicillin + MMX Placebo First|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
182082|NCT01442688|O2|Outcome|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
182084|NCT01442688|O2|Outcome|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
182085|NCT01442688|O1|Outcome|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
182086|NCT01442688|E2|Reported Event|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
182087|NCT01442688|E1|Reported Event|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
182088|NCT01442675|B1|Baseline|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
182089|NCT01442675|P1|Participant Flow|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine in this study.
182090|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
182091|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
182092|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
182093|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
182094|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
182095|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
182096|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
182097|NCT01442675|E1|Reported Event|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age >= 11 years received a single dose of Menactra vaccine
182098|NCT01442376|B4|Baseline|Total|Total of all reporting groups
182099|NCT01442376|B3|Baseline|Ondansetron|"Ondansetron and placebo to Palonosetron
Drug:
Comparator: Ondansetron
Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg
Placebo to Palonosetron"
182100|NCT01442376|B2|Baseline|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron
Intervention:
Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg
Placebo to Ondansetron"
182101|NCT01442376|B1|Baseline|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron
Intervention:
Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg
Placebo to Ondansetron"
182102|NCT01442376|P3|Participant Flow|Ondansetron|"Ondansetron and placebo to Palonosetron
Drug:
Comparator: Ondansetron
Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg
Placebo to Palonosetron"
182103|NCT01442376|P2|Participant Flow|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron
Intervention:
Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg
Placebo to Ondansetron"
182104|NCT01442376|P1|Participant Flow|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron
Intervention:
Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg
Placebo to Ondansetron"
182105|NCT01442376|O3|Outcome|Ondansetron|"Ondansetron and placebo to Palonosetron
Drug:
Comparator: Ondansetron
Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg
Placebo to Palonosetron"
182106|NCT01442376|O2|Outcome|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron
Intervention:
Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg
Placebo to Ondansetron"
182107|NCT01442376|O1|Outcome|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron
Intervention:
Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg
Placebo to Ondansetron"
182108|NCT01442376|O3|Outcome|Ondansetron|"Ondansetron and placebo to Palonosetron
Drug:
Comparator: Ondansetron
Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg
Placebo to Palonosetron"
182109|NCT01442376|O2|Outcome|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron
Intervention:
Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg
Placebo to Ondansetron"
182110|NCT01442376|O1|Outcome|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron
Intervention:
Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg
Placebo to Ondansetron"
182111|NCT01442376|E3|Reported Event|Ondansetron|"Ondansetron and placebo to Palonosetron
Drug:
Comparator: Ondansetron
Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg
Placebo to Palonosetron"
182112|NCT01442376|E2|Reported Event|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron
Intervention:
Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg
Placebo to Ondansetron"
182113|NCT01442376|E1|Reported Event|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron
Intervention:
Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg
Placebo to Ondansetron"
182114|NCT01442181|B3|Baseline|Total|Total of all reporting groups
182115|NCT01442181|B2|Baseline|Medical Therapy|Patients are treated with rhythm and rate control medications.
182116|NCT01442181|B1|Baseline|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182117|NCT01442181|P2|Participant Flow|Medical Therapy|Patients are treated with rhythm and rate control medications.
182120|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182121|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
182122|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182123|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
182124|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182125|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
182126|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182127|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
182128|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182129|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
182130|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182131|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
182132|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182133|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
182134|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182135|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
182136|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182137|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
182138|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182139|NCT01442181|E2|Reported Event|Medical Therapy|Patients are treated with rhythm and rate control medications.
182140|NCT01442181|E1|Reported Event|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
182141|NCT01442155|B1|Baseline|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
Capecitabine: Administered according to the Summary of Product Characteristics.
Oxaliplatin: Administered according to the Summary of Product Characteristics."
182142|NCT01442155|P1|Participant Flow|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
Capecitabine: Administered according to the Summary of Product Characteristics.
Oxaliplatin: Administered according to the Summary of Product Characteristics."
182143|NCT01442155|O1|Outcome|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
Capecitabine: Administered according to the Summary of Product Characteristics.
Oxaliplatin: Administered according to the Summary of Product Characteristics."
182144|NCT01442155|O1|Outcome|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
Capecitabine: Administered according to the Summary of Product Characteristics.
Oxaliplatin: Administered according to the Summary of Product Characteristics."
182145|NCT01442155|E1|Reported Event|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
Capecitabine: Administered according to the Summary of Product Characteristics.
Oxaliplatin: Administered according to the Summary of Product Characteristics."
182146|NCT01442129|B3|Baseline|Total|Total of all reporting groups
182147|NCT01442129|B2|Baseline|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
182148|NCT01442129|B1|Baseline|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs
Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
182149|NCT01442129|P2|Participant Flow|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
182150|NCT01442129|P1|Participant Flow|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs
Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
182151|NCT01442129|O2|Outcome|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
182152|NCT01442129|O1|Outcome|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs
Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
182153|NCT01442129|O2|Outcome|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
182301|NCT01441570|O1|Outcome|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
182154|NCT01442129|O1|Outcome|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs
Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
182155|NCT01442129|E2|Reported Event|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
182156|NCT01442129|E1|Reported Event|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs
Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
182157|NCT01442103|B1|Baseline|Silver Gel, Chronic Wounds|Open, non-comparative, single-centre investigation exploring the clinical utility of a new silver gel for use on chronic wounds.
182158|NCT01442103|P1|Participant Flow|Silver Gel, Chronic Wounds|The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.
182159|NCT01442103|O1|Outcome|Device Common Dressing|Normlgel® Ag is an opaque, amorphous hyrdrogel containing a high (>80%) water content and water soluble polymer chains.
182160|NCT01442103|E1|Reported Event|Device Common Dressing|Normal Ag is an opaque, amorphous hydrogel containing a high watersoluble polymer chains and an antimicrobial silver compund
182161|NCT01442064|B7|Baseline|Total|Total of all reporting groups
182162|NCT01442064|B6|Baseline|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
182163|NCT01442064|B5|Baseline|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
182164|NCT01442064|B4|Baseline|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
182165|NCT01442064|B3|Baseline|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182166|NCT01442064|B2|Baseline|Ranibizumab (0.3 mg BRAVO)|In this extension study participant received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182167|NCT01442064|B1|Baseline|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
182168|NCT01442064|P6|Participant Flow|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
182169|NCT01442064|P5|Participant Flow|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
182170|NCT01442064|P4|Participant Flow|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
182171|NCT01442064|P3|Participant Flow|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182172|NCT01442064|P2|Participant Flow|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182173|NCT01442064|P1|Participant Flow|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
182174|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
182302|NCT01441570|O2|Outcome|Metoprolol|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
217229|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
182175|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
182176|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year)for 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
182177|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182178|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182179|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
182180|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
182181|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
182182|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
182183|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182184|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182185|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
182186|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
182187|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
182188|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
182189|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182190|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182191|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
182192|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
182303|NCT01441570|O1|Outcome|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
182193|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
182194|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
182195|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182196|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182197|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
182198|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
182199|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
182200|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
182201|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182202|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
182203|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
182204|NCT01442064|E3|Reported Event|Ranibizumab (0.5 mg)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.
182205|NCT01442064|E2|Reported Event|Ranibizumab (0.3 mg)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.
182206|NCT01442064|E1|Reported Event|Ranibizumab (Sham)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE and received Ranibizumab during the 6 month observation period of the initial study or this extension study.
182207|NCT01442038|B3|Baseline|Total|Total of all reporting groups
182208|NCT01442038|B2|Baseline|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
182209|NCT01442038|B1|Baseline|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
182210|NCT01442038|P2|Participant Flow|Placebo|Ranolazine placebo (1 tablet) for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
182211|NCT01442038|P1|Participant Flow|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
182304|NCT01441570|E2|Reported Event|Metoprolol|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
182212|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
182213|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
182214|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
182215|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
182216|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
182217|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
182218|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
182219|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
182220|NCT01442038|E2|Reported Event|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
182221|NCT01442038|E1|Reported Event|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
182222|NCT01441973|B3|Baseline|Total|Total of all reporting groups
182223|NCT01441973|B2|Baseline|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
182224|NCT01441973|B1|Baseline|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
182225|NCT01441973|P2|Participant Flow|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
182226|NCT01441973|P1|Participant Flow|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
182227|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
182228|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
182229|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
182230|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
182231|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
182232|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
182233|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
182234|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
182235|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
182236|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
182237|NCT01441973|E2|Reported Event|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
217230|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
182238|NCT01441973|E1|Reported Event|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
182239|NCT01441960|B1|Baseline|Succinylcholine and Rocuronium|All study participants
182240|NCT01441960|P2|Participant Flow|Rocuronium First , Then Succinylcholine|"After induction of anesthesia Rocuronium (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the rocuronium-induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg.
By identifying the optimal (minimal effective) dose of rocuronium, in the subsequent treatment of the subject, Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline."
182241|NCT01441960|P1|Participant Flow|Succinylcholine First, Then Rocuronium|"After induction of anesthesia Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline.
By identifying the optimal (minimal effective) dose of succinylcholine, Rocuronium bromide (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg."
182242|NCT01441960|O2|Outcome|Rocuronium|Duration of induced seizure
182243|NCT01441960|O1|Outcome|Succinylcholine|Duration of induced seizure after standard ECT
182244|NCT01441960|O2|Outcome|Rocuronium|Time to recovery after single bolus administered at the beginning of ECT therapy
182245|NCT01441960|O1|Outcome|Succinylchline|Time to recovery after single bolus administered at the beginning of ECT therapy
182246|NCT01441960|O2|Outcome|NMBA- Rocuronium|Cross-over randomized controlled, assessor blinded clinical trial. Rocuronium: Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments.
182247|NCT01441960|O1|Outcome|NMBA: Sux|"Cross-over randomized controlled, assessor blinded clinical trial.
Succinylcholine: Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'."
182248|NCT01441960|E2|Reported Event|NMBA: Rocuronium|No adverse events occurred during the study
182249|NCT01441960|E1|Reported Event|NMBA: Succinylcholine|No adverse events occurred during the study
182250|NCT01441843|B3|Baseline|Total|Total of all reporting groups
182251|NCT01441843|B2|Baseline|NaCl 0.9%|"NaCl 0.9% 4ml
NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
182252|NCT01441843|B1|Baseline|Lorazepam|"Lorazepam 4mg/4ml
Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
182253|NCT01441843|P2|Participant Flow|NaCl 0.9%|"NaCl 0.9% 4ml
NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
182254|NCT01441843|P1|Participant Flow|Lorazepam|"Lorazepam 4mg/4ml
Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
182255|NCT01441843|O2|Outcome|NaCl 0.9%|"NaCl 0.9% 4ml
NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
182256|NCT01441843|O1|Outcome|Lorazepam|"Lorazepam 4mg/4ml
Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
182257|NCT01441843|E2|Reported Event|NaCl 0.9%|"NaCl 0.9% 4ml
NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
182258|NCT01441843|E1|Reported Event|Lorazepam|"Lorazepam 4mg/4ml
Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
182259|NCT01441765|B3|Baseline|Total|Total of all reporting groups
182260|NCT01441765|B2|Baseline|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
182261|NCT01441765|B1|Baseline|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
182262|NCT01441765|P2|Participant Flow|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
182263|NCT01441765|P1|Participant Flow|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
182264|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
182265|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
182266|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
182267|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
182268|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
182269|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
182270|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
182271|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
182272|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
182273|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
182274|NCT01441765|E2|Reported Event|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
182275|NCT01441765|E1|Reported Event|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks
CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
182276|NCT01441596|B4|Baseline|Total|Total of all reporting groups
182277|NCT01441596|B3|Baseline|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
182278|NCT01441596|B2|Baseline|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
182279|NCT01441596|B1|Baseline|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
182280|NCT01441596|P3|Participant Flow|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
182281|NCT01441596|P2|Participant Flow|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
182282|NCT01441596|P1|Participant Flow|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
182283|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
182284|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
182285|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
182286|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
182287|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
182288|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
182289|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
182290|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
182291|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
182292|NCT01441596|E3|Reported Event|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
182293|NCT01441596|E2|Reported Event|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
182294|NCT01441596|E1|Reported Event|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
182295|NCT01441570|B3|Baseline|Total|Total of all reporting groups
182296|NCT01441570|B2|Baseline|Metoprolol Succinate|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
182297|NCT01441570|B1|Baseline|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
182298|NCT01441570|P2|Participant Flow|Metoprolol Succinate|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
182299|NCT01441570|P1|Participant Flow|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
182300|NCT01441570|O2|Outcome|Metoprolol|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
182305|NCT01441570|E1|Reported Event|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
182306|NCT01441466|B3|Baseline|Total|Total of all reporting groups
182307|NCT01441466|B2|Baseline|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
182308|NCT01441466|B1|Baseline|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
182309|NCT01441466|P2|Participant Flow|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
182310|NCT01441466|P1|Participant Flow|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
182311|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
182312|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.
Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
182313|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
182314|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.
Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
182315|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
182316|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.
Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
182317|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
182318|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.
Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
182319|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
182320|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.
Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
182321|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
182322|NCT01441466|O1|Outcome|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
182323|NCT01441466|E2|Reported Event|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
182324|NCT01441466|E1|Reported Event|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
182325|NCT01441440|B4|Baseline|Total|Total of all reporting groups
182326|NCT01441440|B3|Baseline|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
182327|NCT01441440|B2|Baseline|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
182328|NCT01441440|B1|Baseline|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
182329|NCT01441440|P3|Participant Flow|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
182330|NCT01441440|P2|Participant Flow|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
182331|NCT01441440|P1|Participant Flow|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
182353|NCT01441414|B1|Baseline|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
217231|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
182332|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
182333|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
182334|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
182335|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
182336|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
182337|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
182338|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
182339|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
182340|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
182341|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
182342|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
182343|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
182344|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
182345|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
182346|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
182347|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
182348|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
182349|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
182350|NCT01441440|E3|Reported Event|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
182351|NCT01441440|E2|Reported Event|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
182352|NCT01441440|E1|Reported Event|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
182354|NCT01441414|P1|Participant Flow|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182355|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182356|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182357|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182358|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182359|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182360|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182361|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182362|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182363|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182364|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182365|NCT01441414|O4|Outcome|All-causality CTCAE Grade 5|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 5 TEAEs are presented
182366|NCT01441414|O3|Outcome|All-causality CTCAE Grade 4|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 4 TEAEs are presented
182367|NCT01441414|O2|Outcome|All-causality CTCAE Grade 3|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 3 TEAEs are presented
182368|NCT01441414|O1|Outcome|All-causality CTCAE Grade 2|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 2 TEAEs are presented
182369|NCT01441414|O8|Outcome|Treatment-related Overall|Incidence and severity of treatment-related CTCAE Grades 3,4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
182370|NCT01441414|O7|Outcome|All-causality Overall|Incidence and severity of all-causality CTCAE Grades 3, 4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
182371|NCT01441414|O6|Outcome|Treatment-related CTCAE Grade 5|Incidence and severity of treatment-related CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
182372|NCT01441414|O5|Outcome|Treatment-related CTCAE Grade 4|Incidence and severity of treatment-related CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
182373|NCT01441414|O4|Outcome|Treatment-related CTCAE Grade 3|Incidence and severity of treatment-related CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
182374|NCT01441414|O3|Outcome|All-causality CTCAE Grade 5|Incidence and severity of all-causality CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
182375|NCT01441414|O2|Outcome|All-causality CTCAE Grade 4|Incidence and severity of all-causality CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
182376|NCT01441414|O1|Outcome|All-causality CTCAE Grade 3|Incidence and severity of all-causality CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
182390|NCT01441401|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
182377|NCT01441414|E1|Reported Event|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
182378|NCT01441401|B1|Baseline|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182379|NCT01441401|P1|Participant Flow|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182380|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182381|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182382|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182383|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182384|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182385|NCT01441401|O2|Outcome|Long Term|Participants who received gabapentin for 1 year or more
182386|NCT01441401|O1|Outcome|Non-Long Term|Participants who received gabapentin for less than 1 year
182387|NCT01441401|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
182388|NCT01441401|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
182389|NCT01441401|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
182391|NCT01441401|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
182392|NCT01441401|O3|Outcome|Unknown|Participants with unknown frequency of baseline epileptic seizure
182393|NCT01441401|O2|Outcome|>8 Episodes|Participants with baseline episodes of epileptic seizure more than 8
182394|NCT01441401|O1|Outcome|<=8 Episodes|Participants with baseline episodes of epileptic seizure 8 or less
182395|NCT01441401|O4|Outcome|Unknown|Participants with unknown severity of baseline epileptic seizure
182396|NCT01441401|O3|Outcome|Severe|Participants with severe epileptic seizure at baseline
182397|NCT01441401|O2|Outcome|Moderate|Participants with moderate epileptic seizure at baseline
182398|NCT01441401|O1|Outcome|Mild|Participants with mild epileptic seizure at baseline
182399|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182400|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182401|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182402|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182403|NCT01441401|E1|Reported Event|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
182404|NCT01441245|B3|Baseline|Total|Total of all reporting groups
182405|NCT01441245|B2|Baseline|iIV Group|The group that received the intermittent infusion of furosemide (iIV), consisted of 27 patients.
182406|NCT01441245|B1|Baseline|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
182407|NCT01441245|P2|Participant Flow|iIV Group|The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.
182408|NCT01441245|P1|Participant Flow|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
182409|NCT01441245|O2|Outcome|Dopamine Infusion in iIV|Prevalence of dopamine infusion in intermittent intravenous furosemide infusion.
182410|NCT01441245|O1|Outcome|Dopamine Infusion in cIV|Prevalence of dopamine infusion in continuous intravenous furosemide infusion.
182411|NCT01441245|O2|Outcome|GFR at Discharge in iIV|Mean GFR at discharge in intermittent intravenous fursoemide infusion.
182412|NCT01441245|O1|Outcome|GFR at Discharge in cIV|Mean GFR at discharge in continuous intravenous fursoemide infusion.
182413|NCT01441245|O2|Outcome|GFR Change in iIV|Mean GFR change in intermittent intravenous fursoemide infusion.
182414|NCT01441245|O1|Outcome|GFR Change in cIV|Mean GFR change in continuous intravenous fursoemide infusion.
182415|NCT01441245|O2|Outcome|BNP Change in iIV|Evaluation of BNP change in Intermittent intravenous furosemide infusion group
182416|NCT01441245|O1|Outcome|BNP Change in cIV|Evaluation of BNP change in Intermittent intravenous furosemide infusion group
182596|NCT01440647|O1|Outcome|NIPPV|Extubation to NIPPV when reaching extubation criteria
182417|NCT01441245|O2|Outcome|BNP Levels at Discharge in iIV Group|"The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients
furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
182418|NCT01441245|O1|Outcome|BNP Levels at Discharge in cIV Group|"The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients
furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
182419|NCT01441245|O2|Outcome|Changes in Creatinine in iIV Group|"The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients
furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
182420|NCT01441245|O1|Outcome|Changes in Creatinine in cIV Group|"The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients
furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
182421|NCT01441245|O2|Outcome|Creatinine at Discharge in iIV|Mean creatinine at discharge in intermittent intravenous fursoemide infusion.
182422|NCT01441245|O1|Outcome|Creatinine at Discharge in cIV|Mean creatinine at discharge in continuous intravenous fursoemide infusion.
182423|NCT01441245|O2|Outcome|Lenght of Hospitalization in iIV|Prevalence of hospital stay > 10 days in intermittent intravenous furosemide infusion.
182424|NCT01441245|O1|Outcome|Lenght of Hospitalization in cIV|Prevalence of hospital stay > 10 days in continuous intravenous furosemide infusion.
182425|NCT01441245|O2|Outcome|Urine Output in iIV|Evaluation of urine output in Intermittent intravenous furosemide infusion group
182426|NCT01441245|O1|Outcome|Urine Output in cIV|Evaluation of urine output in Intermittent intravenous furosemide infusion group
182427|NCT01441245|E2|Reported Event|iIV Group|The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.
182428|NCT01441245|E1|Reported Event|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
182429|NCT01441180|B4|Baseline|Total|Total of all reporting groups
182430|NCT01441180|B3|Baseline|Phase 2 Arm B|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
182431|NCT01441180|B2|Baseline|Phase 2 Arm A|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
182432|NCT01441180|B1|Baseline|Phase 1|(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
182433|NCT01441180|P3|Participant Flow|Phase 2 Arm B|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
182434|NCT01441180|P2|Participant Flow|Phase 2 Arm A|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
182435|NCT01441180|P1|Participant Flow|Phase 1|(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
182436|NCT01441180|O3|Outcome|Phase 2 Arm B|"(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
GS7977
RBV"
182437|NCT01441180|O2|Outcome|Phase 2 Arm A|"(N =25) 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
GS7977
RBV"
182438|NCT01441180|O1|Outcome|Phase 1|"Participants (N =10) will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
GS7977
RBV"
182439|NCT01441180|O3|Outcome|Phase 2 Arm B (Sofosbuvir + Low-dose RBV)|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
182440|NCT01441180|O2|Outcome|Phase 2 Arm A (Sofosbuvir + Weight Based RBV)|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
182441|NCT01441180|O1|Outcome|Phase 1|
182442|NCT01441180|E3|Reported Event|Phase 2 Arm B (Sofosbuvir + Low-dose RBV)|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
182443|NCT01441180|E2|Reported Event|Phase 2 Arm A (Sofosbuvir + Weight Based RBV)|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
182444|NCT01441180|E1|Reported Event|Phase 1 (Sofosbuvir + Weight Based RBV)|(N =10): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
182445|NCT01441102|B1|Baseline|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182446|NCT01441102|P1|Participant Flow|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182447|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182597|NCT01440647|O2|Outcome|CPAP|Extubation to CPAP at the discretion of the medical team after extubation criteria were reached
182448|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182449|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182450|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182451|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182452|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182453|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182454|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182455|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182456|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182457|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182458|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182459|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182460|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182461|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182462|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182463|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182464|NCT01441102|E1|Reported Event|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
182465|NCT01441076|B1|Baseline|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182466|NCT01441076|P1|Participant Flow|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182467|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182468|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182469|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182470|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182471|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182472|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182473|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182474|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182475|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182476|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182477|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182478|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182479|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182480|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182481|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
182482|NCT01441076|E1|Reported Event|Anakinra|Treatment with Anakinra 100mg subcutaneous daily
182483|NCT01440972|B3|Baseline|Total|Total of all reporting groups
182484|NCT01440972|B2|Baseline|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
182485|NCT01440972|B1|Baseline|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
182486|NCT01440972|P2|Participant Flow|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
182487|NCT01440972|P1|Participant Flow|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
182598|NCT01440647|O1|Outcome|NIPPV|Extubation to NIPPV when reaching extubation criteria
182488|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
182489|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
182490|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
182491|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
182492|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
182493|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
182494|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
182495|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
182496|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
182497|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
182498|NCT01440972|E2|Reported Event|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
182499|NCT01440972|E1|Reported Event|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
182500|NCT01440959|B1|Baseline|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
182501|NCT01440959|P1|Participant Flow|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
182502|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
182503|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
182504|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
182505|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
182506|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
182507|NCT01440959|E1|Reported Event|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
182508|NCT01440946|B3|Baseline|Total|Total of all reporting groups
182509|NCT01440946|B2|Baseline|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182510|NCT01440946|B1|Baseline|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182511|NCT01440946|P2|Participant Flow|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182512|NCT01440946|P1|Participant Flow|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single intravenous (IV) injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last pharmacokinetic (PK) sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182513|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182514|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182515|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182599|NCT01440647|E2|Reported Event|CPAP|After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life
182600|NCT01440647|E1|Reported Event|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
182516|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182517|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182518|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182519|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182520|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182521|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182522|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182523|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182524|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182525|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182526|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182527|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182528|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182542|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182529|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182530|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182531|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182532|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182533|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182534|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182535|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182536|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182537|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182538|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182539|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182540|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182541|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182543|NCT01440946|O3|Outcome|Total|All Participants
182601|NCT01440634|B3|Baseline|Total|Total of all reporting groups
182602|NCT01440634|B2|Baseline|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
182803|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
182544|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182545|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182546|NCT01440946|E2|Reported Event|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182547|NCT01440946|E1|Reported Event|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.
Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
182548|NCT01440881|B3|Baseline|Total|Total of all reporting groups
182549|NCT01440881|B2|Baseline|Placebo|"infuses at 0.01MCG/KG/min for 48 hours
Placebo: infuses at 0.01MCG/KG/min for 48 hours"
182550|NCT01440881|B1|Baseline|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours
Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
182551|NCT01440881|P2|Participant Flow|Placebo|"infuses at 0.01micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours
Placebo: infuses at 0.01MCG/KG/min for 48 hours"
182552|NCT01440881|P1|Participant Flow|Nesiritide|"infuses at 0.01 micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours
Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
182553|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
182554|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours
Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
182555|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
182556|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours
Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
182557|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
182558|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours
Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
182559|NCT01440881|O2|Outcome|Placebo|"infuses at 0.01MCG/KG/min for 48 hours
Placebo: infuses at 0.01MCG/KG/min for 48 hours"
182560|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours
Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
182561|NCT01440881|E2|Reported Event|Placebo|"infuses at 0.01MCG/KG/min for 48 hours
Placebo: infuses at 0.01MCG/KG/min for 48 hours"
182562|NCT01440881|E1|Reported Event|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours
Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
182563|NCT01440764|B3|Baseline|Total|Total of all reporting groups
182564|NCT01440764|B2|Baseline|F(80) Participants|Participants who consented to participate in the study and receive the Aerosol Furosemide (80mg/8ml solution of Saline) and two Aerosol Saline (8ml) Interventions in any sequence or receive the Aerosol Furosemide (80mg/8ml solution of Saline), Aerosol Saline (8ml), and IV Furosemide (15mg/8ml Saline) Interventions in any sequence.
182565|NCT01440764|B1|Baseline|F(40) Participants|Participants who consented to participate in the study and receive the Aerosol Furosemide (40mg/4ml solution of Saline), Aerosol Saline (4ml), and IV Furosemide (15mg/8ml Saline) Interventions in any sequence.
182566|NCT01440764|P7|Participant Flow|Saline, Then Saline, Then F(80)|"On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes."
182567|NCT01440764|P6|Participant Flow|Saline, Then F(80), Then Saline|"On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes."
182568|NCT01440764|P5|Participant Flow|F(80), Then Saline, Then Saline|"On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes."
182569|NCT01440764|P4|Participant Flow|Saline, Then F(80), Then IV.F|"On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
182593|NCT01440647|P2|Participant Flow|CPAP|After extubation this arm was placed on CPAP (continuous positive airway pressure)and was not offered NIPPV in the first month on life
182594|NCT01440647|P1|Participant Flow|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
182570|NCT01440764|P3|Participant Flow|Saline, Then F(40), Then IV.F|"On Test Day 1, participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
182571|NCT01440764|P2|Participant Flow|IV.F, Then F(40), Then Saline|"On Test Day 1, participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes."
182572|NCT01440764|P1|Participant Flow|F(40), Then Saline, Then IV.F|"On Test Day 1, participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.
On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.
On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
182573|NCT01440764|O5|Outcome|IV Furosemide|"Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day.
To be compared to Aerosol Furosemide (40mg) Arm and Aerosol Saline (4 ml) Arm.
Furosemide"
182574|NCT01440764|O4|Outcome|Aerosol Saline (8 ml)|"Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days.
To be compared to Aerosol Furosemide (80mg) Arm.
Saline"
182575|NCT01440764|O3|Outcome|Aerosol Saline (4 ml)|"Aerosol Saline 4ml by inhalation for 5-10 minutes on 1 test day.
To be compared to Aerosol Furosemide (40mg) Arm and IV Furosemide Arm.
Saline"
182576|NCT01440764|O2|Outcome|Aerosol Furosemide (80mg)|"Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day.
To be compared to Aerosol Saline (8ml) Arm.
Furosemide"
182577|NCT01440764|O1|Outcome|Aerosol Furosemide (40 mg)|"Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on 1 test day.
To be compared to Aerosol Saline (4ml) Arm and IV Furosemide Arm.
Furosemide"
182578|NCT01440764|O2|Outcome|Aerosol Furosemide (80mg)|"Participants who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on a single test day and met quality control.
Of the 12 participants who consented to receive this intervention, all 12 participants received the intervention and completed the study day. However, it was later discovered that 1 subject's data did not pass a priori requirements for quality control and the subject's data was excluded. Therefore, this analysis includes only the 11 subjects who met quality control."
182579|NCT01440764|O1|Outcome|Aerosol Furosemide (40 mg)|"Participants who received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on a single test day and met quality control.
Of the 12 participants who consented to receive this intervention, all 12 participants received the intervention and completed the study day. However, it was later discovered that 1 subject had used cannabis recently and their information was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
182580|NCT01440764|O5|Outcome|Aerosol Saline (8 ml)|"Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days and met quality control.
12 participants who consented to receive this intervention received the intervention and completed the study day. However, 1 subject's physiological data did not meet quality control and was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
182581|NCT01440764|O4|Outcome|Aerosol Furosemide (80mg)|"Participants who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day and met quality control.
12 participants who consented to receive this intervention received the intervention and completed the study day. However, 1 subject's physiological data did not meet quality control and was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
182582|NCT01440764|O3|Outcome|IV Furosemide|"Participants who received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day and met quality control.
Of the 13 participants who consented to receive this intervention, only 12 participants received the intervention and completed the study day (one withdrew before starting this intervention).
Additionally, it was later discovered that 1 subject had used cannabis recently and their data was discarded. Also, 1 subject's data did not meet quality control and was excluded.
Therefore, this analysis includes only the 10 subjects who met quality control."
182583|NCT01440764|O2|Outcome|Aerosol Saline (4 ml)|"Participants who received Aerosol Saline (4ml) by inhalation for 5-10 minutes on a single test day and met quality control.
Of the 12 participants who consented to receive this intervention, only 11 participants received the intervention and completed the study day (one withdrew before starting this intervention).
Additionally, it was later discovered that 1 subject had used cannabis recently and their data was discarded.
Therefore, this analysis includes only the 10 subjects who met quality control."
182584|NCT01440764|O1|Outcome|Aerosol Furosemide (40 mg)|"Participants who received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on a single test day and met quality control.
Of the 12 participants who consented to receive this intervention, all 12 participants received the intervention and completed the study day. However, it was later discovered that 1 subject had used cannabis recently and their information was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
182585|NCT01440764|E5|Reported Event|IV Furosemide|Any subject who received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day.
182586|NCT01440764|E4|Reported Event|Aerosol Saline (8 ml)|Any subject who received Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days.
182587|NCT01440764|E3|Reported Event|Aerosol Saline (4 ml)|Any subject who received Aerosol Saline 4ml by inhalation for 5-10 minutes on 1 test day.
182588|NCT01440764|E2|Reported Event|Aerosol Furosemide (80mg)|Any subject who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day.
182589|NCT01440764|E1|Reported Event|Aerosol Furosemide (40 mg)|Any subject who received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on 1 test day.
182590|NCT01440647|B3|Baseline|Total|Total of all reporting groups
182591|NCT01440647|B2|Baseline|CPAP|After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life
182592|NCT01440647|B1|Baseline|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
182595|NCT01440647|O2|Outcome|CPAP|Extubation to CPAP at the discretion of the medical team after extubation criteria were reached
182603|NCT01440634|B1|Baseline|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
182604|NCT01440634|P2|Participant Flow|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
182605|NCT01440634|P1|Participant Flow|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
182606|NCT01440634|O2|Outcome|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
182607|NCT01440634|O1|Outcome|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
182608|NCT01440634|E2|Reported Event|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
182609|NCT01440634|E1|Reported Event|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
182610|NCT01440595|B3|Baseline|Total|Total of all reporting groups
182611|NCT01440595|B2|Baseline|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
182612|NCT01440595|B1|Baseline|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
182613|NCT01440595|P3|Participant Flow|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
182614|NCT01440595|P2|Participant Flow|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
182615|NCT01440595|P1|Participant Flow|Grazoprevir 200 mg + Peg-IFN + RBV|Grazoprevir 200 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
182616|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
182617|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
182618|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
182619|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
182620|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
182621|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
182622|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
182623|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
182624|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
182625|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
182626|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
182627|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
182628|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
182629|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
182630|NCT01440595|E2|Reported Event|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
182631|NCT01440595|E1|Reported Event|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
182632|NCT01440569|B3|Baseline|Total|Total of all reporting groups
182633|NCT01440569|B2|Baseline|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182634|NCT01440569|B1|Baseline|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182635|NCT01440569|P2|Participant Flow|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182636|NCT01440569|P1|Participant Flow|Treatment-Naive|Treatment-naive participants received darunavir (DRV; 800 mg; 2 × 400 mg tablets) + cobicistat (COBI; 1 × 150 mg tablet) once daily + two nucleoside analogue reverse transcriptase inhibitors (NRTIs; per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182637|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182638|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182639|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182640|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182641|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182642|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182643|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182644|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182645|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182646|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182647|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182648|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182649|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182650|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182651|NCT01440569|E2|Reported Event|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182652|NCT01440569|E1|Reported Event|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
182653|NCT01440543|B5|Baseline|Total|Total of all reporting groups
182654|NCT01440543|B4|Baseline|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
182655|NCT01440543|B3|Baseline|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
182656|NCT01440543|B2|Baseline|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
182657|NCT01440543|B1|Baseline|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
182658|NCT01440543|P4|Participant Flow|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
182659|NCT01440543|P3|Participant Flow|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
182660|NCT01440543|P2|Participant Flow|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
182661|NCT01440543|P1|Participant Flow|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
182662|NCT01440543|O4|Outcome|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
182663|NCT01440543|O3|Outcome|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
182664|NCT01440543|O2|Outcome|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
182665|NCT01440543|O1|Outcome|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
182666|NCT01440543|E4|Reported Event|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
182667|NCT01440543|E3|Reported Event|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
182668|NCT01440543|E2|Reported Event|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
182669|NCT01440543|E1|Reported Event|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
182670|NCT01440517|B1|Baseline|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
182671|NCT01440517|P1|Participant Flow|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
182672|NCT01440517|O1|Outcome|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
182673|NCT01440517|O1|Outcome|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
182674|NCT01440517|E1|Reported Event|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
182675|NCT01440387|B3|Baseline|Total|Total of all reporting groups
182676|NCT01440387|B2|Baseline|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182677|NCT01440387|B1|Baseline|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182678|NCT01440387|P2|Participant Flow|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182679|NCT01440387|P1|Participant Flow|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182680|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182681|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182682|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182683|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182684|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182685|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182686|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182687|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182688|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182689|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182690|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182691|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182692|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182693|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182694|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182695|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182696|NCT01440387|E2|Reported Event|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182697|NCT01440387|E1|Reported Event|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
182698|NCT01440374|B4|Baseline|Total|Total of all reporting groups
182699|NCT01440374|B3|Baseline|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
183534|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
182700|NCT01440374|B2|Baseline|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182701|NCT01440374|B1|Baseline|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
182702|NCT01440374|P4|Participant Flow|Part 3: Eltrombopag|"23 subjects of the 47 randomized to the placebo group in Part 2 entered part 3. 36 subjects of the 98 randomized to the Etrombopag group in Part 2 entered part 3.
All subjects received eltrombopag. Part 3 subjects could also have received treatment for their disease per local SOC, including azacitidine, decitabine, lenalidomide, and chemotherapy. The duration of Part 3 was to be 10 months for subjects from Part 1and 9 months for subjects from Part 2."
182703|NCT01440374|P3|Participant Flow|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182704|NCT01440374|P2|Participant Flow|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182705|NCT01440374|P1|Participant Flow|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 milligrams (mg) daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
182706|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182707|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182708|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182709|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182710|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182711|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182712|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182713|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182714|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182715|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182716|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182717|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182718|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182719|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182720|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182721|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182722|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182723|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182724|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182725|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182726|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182727|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182728|NCT01440374|O1|Outcome|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
182729|NCT01440374|O1|Outcome|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
182730|NCT01440374|O2|Outcome|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
182731|NCT01440374|O1|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
182798|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182799|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
182732|NCT01440374|O1|Outcome|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
182733|NCT01440374|E4|Reported Event|Eltrombopag, Part 3 Plus 30 Days From Part 2 Subjects|Eltrombopag, Part 3 plus 30 Days from Part 2 subjects
182734|NCT01440374|E3|Reported Event|Placebo, Part 2 Plus 1 Day From Part 2 Subjects|Placebo, Part 2 plus 1 day from Part 2 subjects
182735|NCT01440374|E2|Reported Event|Eltrombopag, Part 2 Plus 1 Day From Part 2 Subjects|Eltrombopag, Part 2 plus 1 day from Part 2 subjects
182736|NCT01440374|E1|Reported Event|Eltrombopag, Part 1 Subjects|Eltrombopag, Part 1 subjects
182737|NCT01440322|B3|Baseline|Total|Total of all reporting groups
182738|NCT01440322|B2|Baseline|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182739|NCT01440322|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182740|NCT01440322|P2|Participant Flow|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182741|NCT01440322|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182742|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182743|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182744|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182745|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182746|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182747|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182748|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182749|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182750|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182751|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182752|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182753|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182754|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182755|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182756|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182757|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182758|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182759|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182760|NCT01440322|E2|Reported Event|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
182761|NCT01440322|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
182762|NCT01440283|B1|Baseline|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.
Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
182763|NCT01440283|P1|Participant Flow|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.
Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
182800|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182801|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
182802|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182764|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.
Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
182765|NCT01440283|O6|Outcome|Left Kidney: S-I|Nine participants who underwent all 3 scans.
182766|NCT01440283|O5|Outcome|Left Kidney: A-P|Nine participants who underwent all 3 scans.
182767|NCT01440283|O4|Outcome|Left Kidney: M-L|Nine participants who underwent all 3 scans.
182768|NCT01440283|O3|Outcome|Right Kidney: S-I|Nine participants who underwent all 3 scans.
182769|NCT01440283|O2|Outcome|Right Kidney: A-P|Nine participants who underwent all 3 scans.
182770|NCT01440283|O1|Outcome|Right Kidney: M-L|Nine participants who underwent all 3 scans.
182771|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.
Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
182772|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.
Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
182773|NCT01440283|E1|Reported Event|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.
Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
182774|NCT01440101|B4|Baseline|Total|Total of all reporting groups
182775|NCT01440101|B3|Baseline|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182776|NCT01440101|B2|Baseline|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
182777|NCT01440101|B1|Baseline|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182778|NCT01440101|P3|Participant Flow|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182779|NCT01440101|P2|Participant Flow|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
182780|NCT01440101|P1|Participant Flow|Open Label Natalizumab|300 mg intravenous (IV) infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182781|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182782|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182783|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182784|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
182785|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182786|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
182787|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182788|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182789|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182790|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182791|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182792|NCT01440101|O1|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182793|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182794|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182795|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
182796|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182797|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
183682|NCT01437397|P5|Participant Flow|Placebo|Administered BID by inhalation
182804|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182805|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
182806|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182807|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
182808|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182809|NCT01440101|E3|Reported Event|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182810|NCT01440101|E2|Reported Event|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
182811|NCT01440101|E1|Reported Event|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
182812|NCT01440049|B1|Baseline|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182813|NCT01440049|P1|Participant Flow|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182814|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182815|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182816|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182817|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182818|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182819|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182820|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182821|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182822|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182823|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182824|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182825|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182826|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182827|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182828|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182829|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182830|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182831|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182832|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182833|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182834|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182835|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182836|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182837|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182838|NCT01440049|E1|Reported Event|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
182839|NCT01439971|B6|Baseline|Total|Total of all reporting groups
182840|NCT01439971|B5|Baseline|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182841|NCT01439971|B4|Baseline|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182842|NCT01439971|B3|Baseline|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182843|NCT01439971|B2|Baseline|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182844|NCT01439971|B1|Baseline|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182845|NCT01439971|P5|Participant Flow|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182846|NCT01439971|P4|Participant Flow|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182847|NCT01439971|P3|Participant Flow|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182848|NCT01439971|P2|Participant Flow|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182849|NCT01439971|P1|Participant Flow|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182850|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182851|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182852|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182853|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182854|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182855|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182856|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182857|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182858|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182859|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182860|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182861|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182862|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182863|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182902|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182864|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182865|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182866|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182867|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182868|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182869|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182870|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182871|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182872|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182873|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182874|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182875|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182876|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182877|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182878|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182879|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182880|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182881|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182882|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182883|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182884|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182885|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182886|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182887|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182888|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182889|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182890|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182891|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182892|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182893|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182894|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182895|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182896|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182897|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182898|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182899|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182900|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182901|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182903|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182904|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182905|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182906|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182907|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182908|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182909|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182910|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182911|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182912|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182913|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182914|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182915|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182916|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182917|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182918|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182919|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182920|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182921|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182922|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182923|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182924|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182925|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182926|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182927|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182928|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182929|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182930|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182931|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182932|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182933|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182934|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182935|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182936|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182937|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182938|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182939|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182940|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182941|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182942|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182943|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182944|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182945|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182946|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182947|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182948|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182949|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182950|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182951|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182952|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182953|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182954|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182955|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182956|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182957|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182958|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182959|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182960|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182961|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182962|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182963|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182964|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182965|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182966|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182967|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182968|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182969|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182970|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182971|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182972|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182973|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182974|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182975|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182976|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182977|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182978|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183017|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182979|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182980|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182981|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182982|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182983|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182984|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182985|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182986|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182987|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182988|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182989|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182990|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182991|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182992|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182993|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182994|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
182995|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182996|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182997|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182998|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
182999|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
183000|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183001|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183002|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183003|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183004|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
183005|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183006|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183007|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183008|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183009|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
183010|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183011|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183012|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183013|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183014|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
183015|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183016|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183018|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183019|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
183020|NCT01439971|E5|Reported Event|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183021|NCT01439971|E4|Reported Event|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183022|NCT01439971|E3|Reported Event|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183023|NCT01439971|E2|Reported Event|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
183024|NCT01439971|E1|Reported Event|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
183025|NCT01439945|B4|Baseline|Total|Total of all reporting groups
183026|NCT01439945|B3|Baseline|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.
Week 2:
Patients take one placebo tablets orally (PO) daily (QD).
Week 3:
Patients take two placebo tablets daily (QD).
Weeks 4-9:
Patients take two or three placebo tablets daily (QD)."
183027|NCT01439945|B2|Baseline|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183028|NCT01439945|B1|Baseline|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183029|NCT01439945|P4|Participant Flow|High Dose Placebo|"Week 2:
Patients take one placebo tablets orally (PO) daily (QD).
Week 3:
Patients take two placebo tablets daily (QD).
Weeks 4-9:
Patients take three placebo tablets daily (QD)."
183030|NCT01439945|P3|Participant Flow|Low Dose Placebo|"Week 2:
Patients take one placebo tablets orally (PO) daily (QD).
Week 3:
Patients take two placebo tablets daily (QD).
Weeks 4-9:
Patients take two placebo tablets daily (QD)."
183031|NCT01439945|P2|Participant Flow|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183032|NCT01439945|P1|Participant Flow|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183033|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.
Week 2:
Patients take one placebo tablets orally (PO) daily (QD).
Week 3:
Patients take two placebo tablets daily (QD).
Weeks 4-9:
Patients take two or three placebo tablets daily (QD)."
183034|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183035|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183036|NCT01439945|O2|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.
Week 2:
Patients take one placebo tablets orally (PO) daily (QD).
Week 3:
Patients take two placebo tablets daily (QD).
Weeks 4-9:
Patients take two or three placebo tablets daily (QD)."
183037|NCT01439945|O1|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183038|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.
Week 2:
Patients take one placebo tablets orally (PO) daily (QD).
Week 3:
Patients take two placebo tablets daily (QD).
Weeks 4-9:
Patients take two or three placebo tablets daily (QD)."
183039|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183040|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183041|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.
Week 2:
Patients take one placebo tablets orally (PO) daily (QD).
Week 3:
Patients take two placebo tablets daily (QD).
Weeks 4-9:
Patients take two or three placebo tablets daily (QD)."
183042|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183043|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183155|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183044|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.
Week 2:
Patients take one placebo tablets orally (PO) daily (QD).
Week 3:
Patients take two placebo tablets daily (QD).
Weeks 4-9:
Patients take two or three placebo tablets daily (QD)."
183045|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183046|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183047|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.
Week 2:
Patients take one placebo tablets orally (PO) daily (QD).
Week 3:
Patients take two placebo tablets daily (QD).
Weeks 4-9:
Patients take two or three placebo tablets daily (QD)."
183048|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183049|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183050|NCT01439945|E4|Reported Event|Optional Continuation Phase|After the double blind phase patient questionnaire booklet has been completed and returned to the investigator, the patient will be told whether she was on magnesium or placebo. If the patient wishes to continue or start the magnesium, and healthcare provider approves that this is an appropriate option, she may be registered on the Optional Continuation Phase of the study. This phase will last up to 4 weeks of treatment following either 800 or 1200 mg/day treatment group.
183051|NCT01439945|E3|Reported Event|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.
Week 2:
Patients take one placebo tablets orally (PO) daily (QD).
Week 3:
Patients take two placebo tablets daily (QD).
Weeks 4-9:
Patients take two or three placebo tablets daily (QD)."
183052|NCT01439945|E2|Reported Event|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183053|NCT01439945|E1|Reported Event|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:
Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Week 3:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).
Weeks 4-9:
Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
183054|NCT01439867|B3|Baseline|Total|Total of all reporting groups
183055|NCT01439867|B2|Baseline|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183056|NCT01439867|B1|Baseline|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183057|NCT01439867|P2|Participant Flow|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183058|NCT01439867|P1|Participant Flow|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183059|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183060|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183061|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183062|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183063|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
183064|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183065|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183066|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
183067|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183068|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183069|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
183070|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183071|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183072|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
183073|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183074|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183075|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
183076|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183077|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183078|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
183079|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183080|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183081|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
183082|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183083|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183084|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
183683|NCT01437397|P4|Participant Flow|Formoterol 12 μg|Administered BID by inhalation
183085|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183086|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183087|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
183088|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183089|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183090|NCT01439867|O3|Outcome|Total|Participants received cinacalcet administered daily for 24 weeks.
183091|NCT01439867|O2|Outcome|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183092|NCT01439867|O1|Outcome|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183093|NCT01439867|E3|Reported Event|Total|Participants received cinacalcet administered daily for 24 weeks.
183094|NCT01439867|E2|Reported Event|Cohort 2|Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
183095|NCT01439867|E1|Reported Event|Cohort 1|Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
183096|NCT01439724|B3|Baseline|Total|Total of all reporting groups
183097|NCT01439724|B2|Baseline|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.
Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
183098|NCT01439724|B1|Baseline|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
183099|NCT01439724|P2|Participant Flow|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100mW, 4 Joules(J)/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.
Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
183100|NCT01439724|P1|Participant Flow|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
183116|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183117|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183261|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183101|NCT01439724|O2|Outcome|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.
Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
183102|NCT01439724|O1|Outcome|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
183103|NCT01439724|E2|Reported Event|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.
Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
183104|NCT01439724|E1|Reported Event|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
183105|NCT01439672|B1|Baseline|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.
Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
183106|NCT01439672|P1|Participant Flow|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.
Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
183107|NCT01439672|O1|Outcome|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity. Each subject will be admitted twice approximately 3 weeks apart.
Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
183108|NCT01439672|E1|Reported Event|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.
Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
183109|NCT01439360|B3|Baseline|Total|Total of all reporting groups
183110|NCT01439360|B2|Baseline|Control|In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183111|NCT01439360|B1|Baseline|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183112|NCT01439360|P2|Participant Flow|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183113|NCT01439360|P1|Participant Flow|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183114|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183115|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183118|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183119|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183120|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183121|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183122|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183123|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183124|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183125|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183126|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183127|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183128|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183129|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183130|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183131|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183132|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183133|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183134|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183135|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183136|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183137|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183138|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183139|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183140|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183141|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183142|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183143|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183144|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183145|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183146|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183147|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183148|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183149|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183150|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183151|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183152|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183153|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183154|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183156|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183157|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183158|NCT01439360|E2|Reported Event|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
183159|NCT01439360|E1|Reported Event|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
183160|NCT01439282|B3|Baseline|Total|Total of all reporting groups
183161|NCT01439282|B2|Baseline|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
183162|NCT01439282|B1|Baseline|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
183163|NCT01439282|P2|Participant Flow|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
183164|NCT01439282|P1|Participant Flow|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an intravenous (IV) infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally twice a day (BID) on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
183165|NCT01439282|O2|Outcome|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
183166|NCT01439282|O1|Outcome|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
183167|NCT01439282|O2|Outcome|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
183168|NCT01439282|O1|Outcome|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
183169|NCT01439282|E2|Reported Event|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
183170|NCT01439282|E1|Reported Event|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
183171|NCT01439204|B3|Baseline|Total|Total of all reporting groups
183172|NCT01439204|B2|Baseline|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183173|NCT01439204|B1|Baseline|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183174|NCT01439204|P2|Participant Flow|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183175|NCT01439204|P1|Participant Flow|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183176|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183177|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183178|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183179|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183180|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183181|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183182|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183183|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183184|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183185|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183186|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183187|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183188|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183189|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183190|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183191|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183192|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183193|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183194|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183195|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183196|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183197|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183198|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183199|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183200|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183262|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183201|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183202|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183203|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183204|NCT01439204|E2|Reported Event|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183205|NCT01439204|E1|Reported Event|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
183206|NCT01439126|B3|Baseline|Total|Total of all reporting groups
183207|NCT01439126|B2|Baseline|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
183208|NCT01439126|B1|Baseline|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
183209|NCT01439126|P2|Participant Flow|Subjects on Placebo|"Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
Of 67 Subjects randomized to Placebo:
26 (38.8%) oral dose of 0.4 mg/day 24 (35.8%) oral dose of 0.3 mg/day 15 (22.4%) oral dose of 0.2 mg/day 2 (3.0%) oral dose of 0.1 mg/day"
183210|NCT01439126|P1|Participant Flow|Subjects on KAPVAY (Clonidine Hydrochloride)|"Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period.
All subjects were given study medication at the baseline visit (Visit 2, open label) and instructed to take 1 x 0.1 mg tablet each evening (Day 1) at bedtime until the next visit. Subjects who required an increase in total dose to 0.2 mg/day took 1 x 0.1 mg tablet (0.1 mg) in the morning and at bedtime until the next visit. Those who required a further increase in dose to 0.3 mg/day took 1 x 0.1 mg tablet in the morning and 2 x 0.1 mg tablets at bedtime until the next visit. Patient increasing dose to 0.4 mg/day were instructed to take 2 x 0.1 mg tablets in the morning and at bedtime until the next visit.
Of 68 Subjects randomized to KAPVAY:
24 (35.3%) oral dose of 0.4 mg/day 25 (36.8%) oral dose of 0.3 mg/day 14 (20.6%) oral dose of 0.2 mg/day 5 (7.4%) oral dose of 0.1 mg/day"
183211|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
183212|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
183213|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
183214|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
183215|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
183216|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
183217|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
183218|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
183219|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
183220|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
183221|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
183222|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
183263|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183223|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
183224|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
183225|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
183226|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
183227|NCT01439126|E2|Reported Event|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
183228|NCT01439126|E1|Reported Event|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
183229|NCT01439074|B3|Baseline|Total|Total of all reporting groups
183230|NCT01439074|B2|Baseline|SSD Ag Cream|"Silver Sulphadiazine Ag cream
Silver sulphadiazine: Cream"
183231|NCT01439074|B1|Baseline|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.
Mepilex Ag: Dressing"
183232|NCT01439074|P2|Participant Flow|SSD Ag Cream|"Silver Sulphadiazine Ag cream
Silver sulphadiazine: Cream"
183233|NCT01439074|P1|Participant Flow|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.
Mepilex Ag: Dressing"
183234|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream
Silver sulphadiazine: Cream"
183235|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.
Mepilex Ag: Dressing"
183236|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream
Silver sulphadiazine: Cream"
183237|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.
Mepilex Ag: Dressing"
183238|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream
Silver sulphadiazine: Cream"
183239|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.
Mepilex Ag: Dressing"
183240|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream
Silver sulphadiazine: Cream"
183241|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.
Mepilex Ag: Dressing"
183242|NCT01439074|E2|Reported Event|SSD Ag Cream|"Silver Sulphadiazine Ag cream
Silver sulphadiazine: Cream"
183243|NCT01439074|E1|Reported Event|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.
Mepilex Ag: Dressing"
183244|NCT01438996|B4|Baseline|Total|Total of all reporting groups
183245|NCT01438996|B3|Baseline|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183246|NCT01438996|B2|Baseline|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183247|NCT01438996|B1|Baseline|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183248|NCT01438996|P3|Participant Flow|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183249|NCT01438996|P2|Participant Flow|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183250|NCT01438996|P1|Participant Flow|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183251|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183252|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183253|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183254|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183255|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183256|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183257|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183258|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183259|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183260|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183684|NCT01437397|P3|Participant Flow|Aclidinium 400 μg|Administered BID by inhalation
183264|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183265|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183266|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183267|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183268|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183269|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183270|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183271|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183272|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183273|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183274|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183275|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183276|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183277|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183278|NCT01438996|E3|Reported Event|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
183279|NCT01438996|E2|Reported Event|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
183280|NCT01438996|E1|Reported Event|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
183281|NCT01438814|B3|Baseline|Total|Total of all reporting groups
183282|NCT01438814|B2|Baseline|Met Bid|Patients treated with metformin alone twice daily.
183283|NCT01438814|B1|Baseline|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183284|NCT01438814|P2|Participant Flow|Met Bid|Patients treated with metformin alone twice daily.
183285|NCT01438814|P1|Participant Flow|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183286|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183287|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183288|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183289|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183290|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183291|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183292|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183293|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183294|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183295|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183296|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183297|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183298|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183299|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183300|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183301|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183302|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183303|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183304|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183305|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183306|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183307|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183308|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183309|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183310|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
183311|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183312|NCT01438814|E2|Reported Event|Met Bid|Patients treated with metformin alone twice daily.
183313|NCT01438814|E1|Reported Event|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
183314|NCT01438710|B1|Baseline|Prograf|"Tacrolimus capsules for twice daily oral administration
Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
183351|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183315|NCT01438710|P2|Participant Flow|Prograf|"All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.
Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
183316|NCT01438710|P1|Participant Flow|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.
LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
183317|NCT01438710|O1|Outcome|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.
LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
183318|NCT01438710|E2|Reported Event|Prograf|"All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.
Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
183319|NCT01438710|E1|Reported Event|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.
LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
183320|NCT01438541|B1|Baseline|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
183321|NCT01438541|P1|Participant Flow|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
183322|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
183323|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
183324|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
183325|NCT01438541|E1|Reported Event|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
183326|NCT01438489|B4|Baseline|Total|Total of all reporting groups
183327|NCT01438489|B3|Baseline|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183328|NCT01438489|B2|Baseline|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183329|NCT01438489|B1|Baseline|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183330|NCT01438489|P3|Participant Flow|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183331|NCT01438489|P2|Participant Flow|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183332|NCT01438489|P1|Participant Flow|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183333|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183334|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183335|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183336|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183337|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183338|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183339|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183340|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183341|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183342|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183343|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183344|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183345|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183346|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183347|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183348|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183349|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183350|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183352|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183353|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183354|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183355|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183356|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183357|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183358|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183359|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183360|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183361|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183362|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183363|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183364|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183365|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183366|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183367|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183368|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183369|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183370|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183371|NCT01438489|E3|Reported Event|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183372|NCT01438489|E2|Reported Event|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
183373|NCT01438489|E1|Reported Event|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
183374|NCT01438424|B1|Baseline|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183375|NCT01438424|P1|Participant Flow|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183376|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183377|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183378|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183379|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183380|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183381|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
183382|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183383|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183384|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183385|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183386|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
183387|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183388|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183843|NCT01436799|B3|Baseline|Total|Total of all reporting groups
183389|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183390|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183391|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183392|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183393|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183394|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
183395|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
183396|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
183397|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183398|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
183399|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
183400|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183401|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183402|NCT01438424|E8|Reported Event|Placebo|Participants originally assigned to placebo before protocol change to study drug.
183403|NCT01438424|E7|Reported Event|Missing|Category missing
183404|NCT01438424|E6|Reported Event|Lamovidine, 100 mg|Participants originally received lamovidine with entecavir
183405|NCT01438424|E5|Reported Event|Entecavir, 1.0 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183406|NCT01438424|E4|Reported Event|Entecavir, 0.5 mg|Participants received entecavir QD with lamovidine
183407|NCT01438424|E3|Reported Event|Entecavir, 0.1 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183408|NCT01438424|E2|Reported Event|Entecavir, 0.02588 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
183409|NCT01438424|E1|Reported Event|Adefovir, 10 mg|Participants who received adefovir concomitantly at postdosing follow-up
183410|NCT01438307|B3|Baseline|Total|Total of all reporting groups
183411|NCT01438307|B2|Baseline|Schedule B|Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.
183412|NCT01438307|B1|Baseline|Schedule A|Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.
183413|NCT01438307|P2|Participant Flow|Treatment Schedule B|"Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.
All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
183414|NCT01438307|P1|Participant Flow|Treatment Schedule A|"Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.
All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
183415|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.
Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.
Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
183416|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.
Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.
Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
183535|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183417|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.
Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.
Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
183418|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.
Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.
Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
183419|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.
Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.
Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
183420|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.
Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.
Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
183421|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.
Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.
Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
183422|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.
Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.
Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
183423|NCT01438307|E2|Reported Event|Treatment Schedule B|"Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.
All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
183424|NCT01438307|E1|Reported Event|Treatment Schedule A|"Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.
All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
183425|NCT01438294|B3|Baseline|Total|Total of all reporting groups
183426|NCT01438294|B2|Baseline|Video Game|"The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( reflex ridge- Adventure).
Video game group: The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( adventure- reflex ridge)."
183461|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183536|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183427|NCT01438294|B1|Baseline|Aerobic Exercise|"The aerobic training will be done on the treadmill with heart monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.
Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011)."
183428|NCT01438294|P2|Participant Flow|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
183429|NCT01438294|P1|Participant Flow|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
183430|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
183431|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
183432|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
183433|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
183434|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
183435|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
183436|NCT01438294|E2|Reported Event|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
183462|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183537|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183538|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183437|NCT01438294|E1|Reported Event|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
183438|NCT01438229|B1|Baseline|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183439|NCT01438229|P1|Participant Flow|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183440|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183441|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183442|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183443|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183444|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183445|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183446|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183447|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183448|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183449|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183450|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183451|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183452|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183453|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183454|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183455|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183456|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183457|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183458|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183459|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183460|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183528|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183463|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183464|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183465|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183466|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183467|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183468|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183469|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183470|NCT01438229|E1|Reported Event|Renal Artery Ablation|"Catheter-based RF ablation in renal artery
St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
183471|NCT01438177|B1|Baseline|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.
Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.
Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.
Each cycle is 42 days in length."
183472|NCT01438177|P1|Participant Flow|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.
Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.
Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.
Each cycle is 42 days in length."
183473|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.
Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.
Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.
Each cycle is 42 days in length."
183474|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.
Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.
Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.
Each cycle is 42 days in length."
183475|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.
Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.
Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.
Each cycle is 42 days in length."
183476|NCT01438177|E1|Reported Event|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.
Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.
Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.
Each cycle is 42 days in length."
183477|NCT01438151|B1|Baseline|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
183478|NCT01438151|P1|Participant Flow|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
183479|NCT01438151|O1|Outcome|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
183529|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183530|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183531|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183532|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183533|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183480|NCT01438151|E1|Reported Event|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
183481|NCT01438060|B3|Baseline|Total|Total of all reporting groups
183482|NCT01438060|B2|Baseline|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183483|NCT01438060|B1|Baseline|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
183484|NCT01438060|P2|Participant Flow|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183485|NCT01438060|P1|Participant Flow|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
183486|NCT01438060|O1|Outcome|Aripiprazole|Treatment beyond 140 weeks: Dosed at 2-15 mg/day (flexible dosing).
183487|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
183488|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
183489|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
183490|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
183491|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
183492|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
183493|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
183494|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
183495|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
183496|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
183497|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183498|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183499|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183500|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
183501|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183502|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183503|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183504|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183505|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183506|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183507|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183508|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183509|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183510|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183511|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183512|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183513|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183514|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183515|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183516|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183517|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183518|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183519|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183520|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183521|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183522|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183523|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183524|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183525|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183526|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183527|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183539|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183540|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183541|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183542|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183543|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183544|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183545|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183546|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183547|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183548|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183549|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183550|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183551|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183552|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183553|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183554|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183555|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183556|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183557|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
183558|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
183559|NCT01438060|E3|Reported Event|3 Ext - Aripiprazole|
183560|NCT01438060|E2|Reported Event|2 Double Blind Placebo|
183561|NCT01438060|E1|Reported Event|1 Double Blind Aripiprazole|
183562|NCT01437995|B4|Baseline|Total|Total of all reporting groups
183563|NCT01437995|B3|Baseline|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
183564|NCT01437995|B2|Baseline|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
183565|NCT01437995|B1|Baseline|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
183566|NCT01437995|P3|Participant Flow|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
183567|NCT01437995|P2|Participant Flow|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
183568|NCT01437995|P1|Participant Flow|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
183569|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
183570|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
183571|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
183572|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
183573|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
183574|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
183575|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
183576|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
183577|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
183578|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
183579|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
183580|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
183581|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
183582|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
183625|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183583|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
183584|NCT01437995|E3|Reported Event|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
183585|NCT01437995|E2|Reported Event|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
183586|NCT01437995|E1|Reported Event|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
183587|NCT01437943|B3|Baseline|Total|Total of all reporting groups
183588|NCT01437943|B2|Baseline|Placebo|"Placebo daily for 180 days
Placebo: Take 1 tablet (0 mg) daily for 180 days"
183589|NCT01437943|B1|Baseline|Aliskiren|"Aliskiren 150 mg daily for 180 days
Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
183590|NCT01437943|P2|Participant Flow|Placebo|"Placebo daily for 180 days
Placebo: Take 1 tablet by mouth daily for 180 days"
183591|NCT01437943|P1|Participant Flow|Aliskiren|"Aliskiren 150 mg daily for 180 days
Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
183592|NCT01437943|O2|Outcome|Placebo|"Placebo identical to Aliskiren drug daily for 180 days
Placebo: Take 1 tablet (0 mg) daily for 180 days."
183593|NCT01437943|O1|Outcome|Aliskiren|"Aliskiren 150 mg daily for 180 days
Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
183594|NCT01437943|E2|Reported Event|Placebo|"Placebo daily for 180 days
Placebo: Take 1 tablet by mouth daily for 180 days"
183595|NCT01437943|E1|Reported Event|Aliskiren|"Aliskiren 150 mg daily for 180 days
Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
183596|NCT01437878|B3|Baseline|Total|Total of all reporting groups
183597|NCT01437878|B2|Baseline|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183598|NCT01437878|B1|Baseline|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183599|NCT01437878|P2|Participant Flow|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183600|NCT01437878|P1|Participant Flow|Iloprost|"single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183601|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183602|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183603|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183604|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183605|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183606|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183607|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183608|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183609|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183610|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183611|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183612|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183613|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183614|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183615|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183616|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183617|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183618|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183619|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183620|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183621|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183622|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183623|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183624|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183626|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183627|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183628|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183629|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183630|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183631|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183632|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183633|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183634|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183635|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183636|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183637|NCT01437878|E2|Reported Event|Placebo|"matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo"
183638|NCT01437878|E1|Reported Event|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system
Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
183639|NCT01437540|B3|Baseline|Total|Total of all reporting groups
183640|NCT01437540|B2|Baseline|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
183641|NCT01437540|B1|Baseline|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
183642|NCT01437540|P2|Participant Flow|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
183643|NCT01437540|P1|Participant Flow|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
183644|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
183645|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
183646|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
183647|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
183648|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
183649|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
183650|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
183651|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
183652|NCT01437540|E2|Reported Event|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
183653|NCT01437540|E1|Reported Event|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
183654|NCT01437501|B3|Baseline|Total|Total of all reporting groups
183655|NCT01437501|B2|Baseline|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
183656|NCT01437501|B1|Baseline|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
183657|NCT01437501|P2|Participant Flow|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
183658|NCT01437501|P1|Participant Flow|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
183659|NCT01437501|O2|Outcome|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
183660|NCT01437501|O1|Outcome|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
183661|NCT01437501|E2|Reported Event|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
183662|NCT01437501|E1|Reported Event|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
183663|NCT01437488|B1|Baseline|Cabazitaxel|"Cabazitaxel following platinum-based chemotherapy
Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days
Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion
Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator
Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly durin"
183681|NCT01437397|B1|Baseline|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
183664|NCT01437488|P1|Participant Flow|Cabazitaxel|"Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days
Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion
Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator
Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days
CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)
Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly durin"
183665|NCT01437488|O1|Outcome|Cabazitaxel|"Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days
Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion
Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator
Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days
CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)
Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment"
183666|NCT01437488|O1|Outcome|Cabazitaxel|"Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days
Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion
Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment"
183667|NCT01437488|O1|Outcome|Cabazitaxel|"Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days
Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion
Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator
Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days
CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)
Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly durin"
183668|NCT01437488|E1|Reported Event|Cabazitaxel|"Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days
Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion
Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator
Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days
CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)
Blood Draw: Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment"
183669|NCT01437423|B1|Baseline|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
183670|NCT01437423|P1|Participant Flow|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
183671|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
183672|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
183673|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
183674|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
183675|NCT01437423|E1|Reported Event|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
183676|NCT01437397|B6|Baseline|Total|Total of all reporting groups
183677|NCT01437397|B5|Baseline|Placebo|Administered BID by inhalation
183678|NCT01437397|B4|Baseline|Formoterol 12 μg|Administered BID by inhalation
183679|NCT01437397|B3|Baseline|Aclidinium 400 μg|Administered BID by inhalation
183680|NCT01437397|B2|Baseline|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
183685|NCT01437397|P2|Participant Flow|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
183686|NCT01437397|P1|Participant Flow|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
183687|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
183688|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
183689|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
183690|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
183691|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
183692|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
183693|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
183694|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
183695|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
183696|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
183697|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
183698|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
183699|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
183700|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
183701|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
183702|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
183703|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
183704|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
183705|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
183706|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
183707|NCT01437397|E5|Reported Event|Placebo|Administered BID by inhalation
183708|NCT01437397|E4|Reported Event|Formoterol 12 μg|Administered BID by inhalation
183709|NCT01437397|E3|Reported Event|Aclidinium 400 μg|Administered BID by inhalation
183710|NCT01437397|E2|Reported Event|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
183711|NCT01437397|E1|Reported Event|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
183712|NCT01437319|B1|Baseline|Overall|The analysis population consists of all subjects that were enrolled into the study.
183713|NCT01437319|P3|Participant Flow|Balfilcon A|Subjects that received balafilcon A lens in Phase II.
183714|NCT01437319|P2|Participant Flow|Comfilcon A|Subjects that received comfilcon A lens in Phase II.
183715|NCT01437319|P1|Participant Flow|Lotrafilcon A|All subjects received lotrafilcon A in Phase I.
183716|NCT01437319|O2|Outcome|Non-repeat Mucin Ball Former|Subjects that were classified as Non-repeat Mucin Ball Former
183717|NCT01437319|O1|Outcome|Repeat Mucin Ball Former|Subjects that were classified as being repeat Mucin Ball former
183718|NCT01437319|O2|Outcome|Non-repeat Mucin Ball Former|Subjects that were classified as Non-repeat Mucin Ball Former.
183719|NCT01437319|O1|Outcome|Repeat Mucin Ball Former|Subjects that were classified as being repeat Mucin Ball former.
183720|NCT01437319|E3|Reported Event|Lotrafilcon A|All Subjects received lotrafilcon A in Phase I of the study.
183721|NCT01437319|E2|Reported Event|Balafilcon A|Subjects who received balafilcon A in Phase II of the study
183722|NCT01437319|E1|Reported Event|Comfilcon A|Subjects who received comfilcon A in Phase II of the study.
183723|NCT01437267|B7|Baseline|Total|Total of all reporting groups
183724|NCT01437267|B6|Baseline|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
183725|NCT01437267|B5|Baseline|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
183726|NCT01437267|B4|Baseline|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
183727|NCT01437267|B3|Baseline|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183728|NCT01437267|B2|Baseline|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
183729|NCT01437267|B1|Baseline|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183730|NCT01437267|P6|Participant Flow|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
183731|NCT01437267|P5|Participant Flow|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
183732|NCT01437267|P4|Participant Flow|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
183733|NCT01437267|P3|Participant Flow|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183734|NCT01437267|P2|Participant Flow|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
183735|NCT01437267|P1|Participant Flow|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183736|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
183737|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
183738|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
183739|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183740|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
183741|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183742|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
183743|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
183744|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
183745|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183746|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
183747|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183748|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
183749|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
183750|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
183751|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183752|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
183753|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183754|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
183755|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
183756|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
183757|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183758|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
183759|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183760|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
183761|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
183762|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
183763|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183764|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
183765|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183766|NCT01437267|E6|Reported Event|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
183767|NCT01437267|E5|Reported Event|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
183768|NCT01437267|E4|Reported Event|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
183769|NCT01437267|E3|Reported Event|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183770|NCT01437267|E2|Reported Event|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
183771|NCT01437267|E1|Reported Event|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
183772|NCT01437124|B1|Baseline|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
183773|NCT01437124|P1|Participant Flow|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
183774|NCT01437124|O1|Outcome|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
183775|NCT01437124|O1|Outcome|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
183776|NCT01437124|E1|Reported Event|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
183777|NCT01437111|B1|Baseline|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
183778|NCT01437111|P1|Participant Flow|Fosamax Plus: All Participants|All participants who were enrolled in the study to receive one oral combination tablet of Fosamax Plus weekly.
183779|NCT01437111|O4|Outcome|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
183780|NCT01437111|O3|Outcome|Fosamax Plus: Treatment Naive at Baseline|Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
183781|NCT01437111|O2|Outcome|Fosamax Plus: Other Osteoporosis Therapy at Baseline|Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
183782|NCT01437111|O1|Outcome|Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline|Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
183783|NCT01437111|O4|Outcome|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
183784|NCT01437111|O3|Outcome|Fosamax Plus: Treatment Naive at Baseline|Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
183785|NCT01437111|O2|Outcome|Fosamax Plus: Other Osteoporosis Therapy at Baseline|Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
184719|NCT01434186|P1|Participant Flow|Placebo|Placebo matching saxagliptin
183786|NCT01437111|O1|Outcome|Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline|Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
183787|NCT01437111|E1|Reported Event|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
183788|NCT01437098|B1|Baseline|MDT-2111 TAVI|Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
183789|NCT01437098|P1|Participant Flow|MDT-2111 TAVI|Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
183790|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183791|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183792|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183793|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183794|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183795|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183796|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183797|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183798|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183799|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183800|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183801|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183802|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183803|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183804|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183805|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183806|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183807|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183808|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183809|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183810|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183811|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183812|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183813|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183814|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183815|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183816|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183817|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183818|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183819|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183820|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183821|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183822|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183823|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183824|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183825|NCT01437098|O1|Outcome|As Treated Population With Index Procedure|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
183826|NCT01437098|O1|Outcome|As Treated Population With Index Procedure|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
183827|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed..
183828|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed..
183829|NCT01437098|O1|Outcome|As Treated (AT) Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183830|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183831|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
183832|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183833|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183834|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183835|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183836|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183837|NCT01437098|O2|Outcome|Iliofemoral Implanted Subjects|The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183838|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
183839|NCT01437098|E4|Reported Event|All Subjects (As Treated Subjects)|This includes subjects from all access approaches, iliofemoral, subclavian and direct aortic.
183840|NCT01437098|E3|Reported Event|Direct Aortic (As Treated Subjects)|For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in oversea(EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches.
183841|NCT01437098|E2|Reported Event|Subclavian (As Treated Subjects)|The subclavian access is additionally chosen (as the secondary access site) when physicians may require an alternative to the femoral access site for patients who would benefit from the therapy but have unfavorable peripheral vasculature such as excessive atherosclerosis, calcifications, or tortuosity of common femoral arteries.
183842|NCT01437098|E1|Reported Event|Iliofemoral (As Treated Subjects)|The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients.
183844|NCT01436799|B2|Baseline|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
183845|NCT01436799|B1|Baseline|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
183846|NCT01436799|P2|Participant Flow|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
183847|NCT01436799|P1|Participant Flow|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
183848|NCT01436799|O2|Outcome|Propofol|anesthetic maintanence with propofol
183849|NCT01436799|O1|Outcome|Desflurane|anesthetic maintenence with desflurane
183850|NCT01436799|E2|Reported Event|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
183851|NCT01436799|E1|Reported Event|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
183852|NCT01436643|B4|Baseline|Total|Total of all reporting groups
183853|NCT01436643|B3|Baseline|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
183854|NCT01436643|B2|Baseline|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
183855|NCT01436643|B1|Baseline|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
183856|NCT01436643|P4|Participant Flow|Pre-treatment With Fingolimod|During 2weeks pre-treatment period patients received Fingolimod 0.5 mg per capsule (hard gelatin capsules) orally once daily.
183857|NCT01436643|P3|Participant Flow|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
183858|NCT01436643|P2|Participant Flow|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
183859|NCT01436643|P1|Participant Flow|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
183860|NCT01436643|O4|Outcome|Fingolimod|2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
183861|NCT01436643|O3|Outcome|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
183862|NCT01436643|O2|Outcome|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
183863|NCT01436643|O1|Outcome|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
183864|NCT01436643|E4|Reported Event|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
183865|NCT01436643|E3|Reported Event|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
183866|NCT01436643|E2|Reported Event|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
183867|NCT01436643|E1|Reported Event|Fingolimod|2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
183868|NCT01436526|B3|Baseline|Total|Total of all reporting groups
183869|NCT01436526|B2|Baseline|Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg|Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
183870|NCT01436526|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg , Then 1*10 mg|Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
183871|NCT01436526|P2|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg|Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
183872|NCT01436526|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg, Then 1*10 mg|Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
183873|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
183874|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
184698|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
183875|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
183876|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
183877|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
183878|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
183879|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
183880|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
183881|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
183882|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
183883|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
183884|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
183885|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
183886|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
183887|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
183888|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
183889|NCT01436526|E2|Reported Event|Rivaroxaban 1*10 mg (Xarelto, BAY59-7939)|Single oral dose of 1*10 mg rivaroxaban tablet administered under fasting conditions
183890|NCT01436526|E1|Reported Event|Rivaroxaban 2*5 mg (Xarelto, BAY59-7939)|Single oral dose of 2*5 mg rivaroxaban tablets administered under fasting conditions
183891|NCT01436500|B3|Baseline|Total|Total of all reporting groups
183892|NCT01436500|B2|Baseline|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
183893|NCT01436500|B1|Baseline|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
183894|NCT01436500|P5|Participant Flow|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
183895|NCT01436500|P4|Participant Flow|150 mg Ifetroban|150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
183896|NCT01436500|P3|Participant Flow|50 mg Ifetroban|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
183897|NCT01436500|P2|Participant Flow|15 mg Ifetroban|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
183898|NCT01436500|P1|Participant Flow|5 mg Ifetroban|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
183899|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
183900|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
183901|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
183902|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
183903|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
183904|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
183905|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
183906|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
183907|NCT01436500|O7|Outcome|150 mg Ifetroban, Type 2|"60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183908|NCT01436500|O6|Outcome|50 mg Ifetroban, Type 2|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183909|NCT01436500|O5|Outcome|50 mg Ifetroban, Type 1|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183910|NCT01436500|O4|Outcome|15 mg Ifetroban, Type 2|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183911|NCT01436500|O3|Outcome|15 mg Ifetroban, Type 1|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183912|NCT01436500|O2|Outcome|5 mg Ifetroban, Type 2|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183913|NCT01436500|O1|Outcome|5 mg Ifetroban, Type 1|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183914|NCT01436500|O7|Outcome|150 mg Ifetroban, Type 2|"60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183915|NCT01436500|O6|Outcome|50 mg Ifetroban, Type 2|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
184528|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
183916|NCT01436500|O5|Outcome|50 mg Ifetroban, Type 1|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183917|NCT01436500|O4|Outcome|15 mg Ifetroban, Type 2|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183918|NCT01436500|O3|Outcome|15 mg Ifetroban, Type 1|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183919|NCT01436500|O2|Outcome|5 mg Ifetroban, Type 2|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183920|NCT01436500|O1|Outcome|5 mg Ifetroban, Type 1|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183921|NCT01436500|O7|Outcome|150 mg Ifetroban, Type 2|"60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183922|NCT01436500|O6|Outcome|50 mg Ifetroban, Type 2|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183923|NCT01436500|O5|Outcome|50 mg Ifetroban, Type 1|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183924|NCT01436500|O4|Outcome|15 mg Ifetroban, Type 2|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183925|NCT01436500|O3|Outcome|15 mg Ifetroban, Type 1|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183926|NCT01436500|O2|Outcome|5 mg Ifetroban, Type 2|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183927|NCT01436500|O1|Outcome|5 mg Ifetroban, Type 1|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
183928|NCT01436500|E2|Reported Event|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
183929|NCT01436500|E1|Reported Event|Ifetroban|5, 15, 50 or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
183930|NCT01436435|B1|Baseline|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Jetstream Atherectomy System: Atherectomy"
183931|NCT01436435|P1|Participant Flow|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Jetstream Atherectomy System: Atherectomy"
183932|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Jetstream Atherectomy System: Atherectomy"
183933|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Jetstream Atherectomy System: Atherectomy"
183934|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Jetstream Atherectomy System: Atherectomy"
183935|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Jetstream Atherectomy System: Atherectomy"
183936|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Jetstream Atherectomy System: Atherectomy"
183937|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Jetstream Atherectomy System: Atherectomy"
183938|NCT01436435|E1|Reported Event|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Jetstream Atherectomy System: Atherectomy"
183939|NCT01436370|B9|Baseline|Total|Total of all reporting groups
183940|NCT01436370|B8|Baseline|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183941|NCT01436370|B7|Baseline|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183942|NCT01436370|B6|Baseline|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183943|NCT01436370|B5|Baseline|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183944|NCT01436370|B4|Baseline|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
184720|NCT01434186|O2|Outcome|Placebo|Saxagliptin matching placebo
183945|NCT01436370|B3|Baseline|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183946|NCT01436370|B2|Baseline|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183947|NCT01436370|B1|Baseline|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183948|NCT01436370|P8|Participant Flow|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183949|NCT01436370|P7|Participant Flow|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183950|NCT01436370|P6|Participant Flow|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183951|NCT01436370|P5|Participant Flow|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183952|NCT01436370|P4|Participant Flow|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183953|NCT01436370|P3|Participant Flow|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183954|NCT01436370|P2|Participant Flow|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183955|NCT01436370|P1|Participant Flow|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183956|NCT01436370|O4|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183957|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183958|NCT01436370|O2|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183959|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183960|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183961|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183962|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183963|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183964|NCT01436370|O4|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183965|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183966|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183967|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183968|NCT01436370|O2|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183969|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183970|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183971|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183972|NCT01436370|O2|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183973|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183974|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183975|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183976|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183977|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183978|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183979|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183980|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183981|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183982|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183983|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183984|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183985|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183986|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183987|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183988|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183989|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183990|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183991|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183992|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183993|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
183994|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183995|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
183996|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183997|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
183998|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
183999|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
184000|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
184001|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
184002|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
184003|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
184004|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
184005|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
184006|NCT01436370|O4|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
184007|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
184008|NCT01436370|O2|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
184009|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
184010|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
184011|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
184012|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
184013|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
184014|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
184015|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
184016|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
184017|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
184018|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
184019|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
184020|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
184021|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
184022|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
184023|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
184024|NCT01436370|E8|Reported Event|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
184025|NCT01436370|E7|Reported Event|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
184026|NCT01436370|E6|Reported Event|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
184027|NCT01436370|E5|Reported Event|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
184028|NCT01436370|E4|Reported Event|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
184029|NCT01436370|E3|Reported Event|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
184030|NCT01436370|E2|Reported Event|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
184031|NCT01436370|E1|Reported Event|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
184032|NCT01436305|B4|Baseline|Total|Total of all reporting groups
184033|NCT01436305|B3|Baseline|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184164|NCT01436253|B1|Baseline|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
184165|NCT01436253|P1|Participant Flow|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
184166|NCT01436253|O1|Outcome|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid values on their current therapy.
184034|NCT01436305|B2|Baseline|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184035|NCT01436305|B1|Baseline|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184036|NCT01436305|P3|Participant Flow|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184037|NCT01436305|P2|Participant Flow|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184038|NCT01436305|P1|Participant Flow|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184039|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184040|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184041|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184042|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184043|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184044|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184045|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184046|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184047|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184048|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184049|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184050|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184051|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184052|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184053|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184054|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184055|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184056|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184065|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184057|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184058|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184059|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184060|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184061|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184062|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184063|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184064|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184066|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184067|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184068|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184069|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184070|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184071|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184072|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184073|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184074|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184075|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184076|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184077|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184078|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184079|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184080|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184089|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184081|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184082|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184083|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184084|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184085|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184086|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184087|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184088|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184090|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184091|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184092|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184093|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184094|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184095|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184096|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184097|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184098|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184099|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184100|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184101|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184102|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184103|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184104|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184113|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184105|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184106|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184107|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184108|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184109|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184110|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184111|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184112|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184114|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184115|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184116|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184117|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184118|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184119|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184120|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184121|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184122|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184123|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184124|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184125|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184126|NCT01436305|O3|Outcome|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184127|NCT01436305|O2|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184128|NCT01436305|O1|Outcome|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184158|NCT01436266|P2|Participant Flow|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
184159|NCT01436266|P1|Participant Flow|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
184160|NCT01436266|O2|Outcome|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
184161|NCT01436266|O1|Outcome|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
184162|NCT01436266|E2|Reported Event|Placebo (Folic Acid)|"Two 1-mg tablets buccally 2 hours prior to procedure
Folic acid: 2mg buccally 2 hours prior to procedure"
184163|NCT01436266|E1|Reported Event|Misoprostol|"400 mcg buccally 2 hours prior to procedure
Misoprostol: 400 mcg buccally 2 hours prior to procedure"
184129|NCT01436305|E3|Reported Event|Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac|"Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped."
184130|NCT01436305|E2|Reported Event|Induction: Alemtuzumab, Maintenance: MMF + Belatacept|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks."
184131|NCT01436305|E1|Reported Event|Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus|"Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.
Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.
Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.
Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.
Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter."
184132|NCT01436279|B3|Baseline|Total|Total of all reporting groups
184133|NCT01436279|B2|Baseline|Osmotic Dilators|Placed 20-24 hours prior to procedure
184134|NCT01436279|B1|Baseline|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
184135|NCT01436279|P2|Participant Flow|Osmotic Dilators|"Placed 20-24 hours prior to procedure
osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
184136|NCT01436279|P1|Participant Flow|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
Mifepristone: 200 mg po 20-24 hours prior to the procedure"
184137|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure
osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
184138|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
Mifepristone: 200 mg po 20-24 hours prior to the procedure"
184139|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure
osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
184140|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
Mifepristone: 200 mg po 20-24 hours prior to the procedure"
184141|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure
osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
184142|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
Mifepristone: 200 mg po 20-24 hours prior to the procedure"
184143|NCT01436279|O2|Outcome|Osmotic Dilators|Placed 20-24 hours prior to procedure
184144|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
184145|NCT01436279|O2|Outcome|Osmotic Dilators|Placed 20-24 hours prior to procedure
184146|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
184147|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure
osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
184148|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
Mifepristone: 200 mg po 20-24 hours prior to the procedure"
184149|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure
osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
184150|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
Mifepristone: 200 mg po 20-24 hours prior to the procedure"
184151|NCT01436279|O2|Outcome|Osmotic Dilators|Placed 20-24 hours prior to procedure
184152|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
184153|NCT01436279|E2|Reported Event|Osmotic Dilators|"Placed 20-24 hours prior to procedure
osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
184154|NCT01436279|E1|Reported Event|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
Mifepristone: 200 mg po 20-24 hours prior to the procedure"
184155|NCT01436266|B3|Baseline|Total|Total of all reporting groups
184156|NCT01436266|B2|Baseline|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
184157|NCT01436266|B1|Baseline|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
184167|NCT01436253|O1|Outcome|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid values on their current therapy.
184168|NCT01436253|E1|Reported Event|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
184169|NCT01436201|B1|Baseline|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
184170|NCT01436201|P1|Participant Flow|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
184171|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
184172|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
184173|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
184174|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
184175|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
184176|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
184177|NCT01436201|E2|Reported Event|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.
Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
184178|NCT01436201|E1|Reported Event|Digoxin|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
184179|NCT01436175|B1|Baseline|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184180|NCT01436175|P1|Participant Flow|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184181|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184182|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184183|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184184|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184185|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184186|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184187|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184188|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184301|NCT01436084|P1|Participant Flow|SB1518|400 mg orally a day for 28 day cycle.
184302|NCT01436084|O1|Outcome|SB1518|400 mg orally a day for 28 day cycle.
184189|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 (Lisdexamfetamine dimesylate) + Antidepressant: SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
184190|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184191|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184192|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184193|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184194|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184195|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184196|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184197|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184198|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184199|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184200|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184201|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184202|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184203|NCT01436175|E1|Reported Event|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
184204|NCT01436162|B3|Baseline|Total|Total of all reporting groups
184205|NCT01436162|B2|Baseline|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks.
184206|NCT01436162|B1|Baseline|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among a 20, 30, 50, or 70 mg dose) for 8 weeks.
184207|NCT01436162|P3|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
184303|NCT01436084|E1|Reported Event|SB1518|400 mg orally a day for 28 day cycle.
184304|NCT01436071|B3|Baseline|Total|Total of all reporting groups
184208|NCT01436162|P2|Participant Flow|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among a 20, 30, 50, or 70 mg dose).
184209|NCT01436162|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489).
184210|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
184211|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184212|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184213|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184214|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184215|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184216|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184217|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184218|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184219|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184220|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184221|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184222|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184223|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184224|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184225|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184226|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184227|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184228|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184229|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184230|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184231|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184232|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184233|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184234|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184235|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184236|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184237|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184238|NCT01436162|E2|Reported Event|Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
184239|NCT01436162|E1|Reported Event|SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate ): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks
184240|NCT01436149|B3|Baseline|Total|Total of all reporting groups
184241|NCT01436149|B2|Baseline|Antidepressant + Double-blind SPD489|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose) for 8 weeks.
184242|NCT01436149|B1|Baseline|Antidepressant + Double-blind Placebo|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks.
184243|NCT01436149|P3|Participant Flow|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose).
184244|NCT01436149|P2|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
184245|NCT01436149|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended-release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489).
184246|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184247|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184248|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184249|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184250|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184251|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184252|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184253|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184529|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
184254|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184255|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184256|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184257|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184258|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184259|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184260|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184261|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184262|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184263|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184264|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184265|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184266|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184267|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184268|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
184269|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
184270|NCT01436149|E2|Reported Event|Antidepressant + SPD489|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50 or 70 mg dose).
184271|NCT01436149|E1|Reported Event|Antidepressant + Placebo|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
184272|NCT01436110|B4|Baseline|Total|Total of all reporting groups
184273|NCT01436110|B3|Baseline|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184274|NCT01436110|B2|Baseline|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184275|NCT01436110|B1|Baseline|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184276|NCT01436110|P3|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184305|NCT01436071|B2|Baseline|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184277|NCT01436110|P2|Participant Flow|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184278|NCT01436110|P1|Participant Flow|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184279|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184280|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184281|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184282|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184283|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184284|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184285|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184286|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184287|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184288|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184289|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184290|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184291|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184292|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184293|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184294|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184295|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184296|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184297|NCT01436110|E3|Reported Event|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184298|NCT01436110|E2|Reported Event|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184299|NCT01436110|E1|Reported Event|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184300|NCT01436084|B1|Baseline|SB1518|400 mg orally a day for 28 day cycle.
184306|NCT01436071|B1|Baseline|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184307|NCT01436071|P2|Participant Flow|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184308|NCT01436071|P1|Participant Flow|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184309|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184310|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184311|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184312|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184313|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184314|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184315|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184316|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184317|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184318|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184319|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184320|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184321|NCT01436071|E2|Reported Event|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184322|NCT01436071|E1|Reported Event|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
184323|NCT01436045|B1|Baseline|All Study Partipants|Participants who received either intranasal glulisine (0.10 milliliter (mL) in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.
184324|NCT01436045|P2|Participant Flow|Placebo, Then Insulin Glulisine|"A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.
Placebo (5 minutes), Washout (1 week), Insulin Glulisine (5 minutes)
Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)
Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)"
184325|NCT01436045|P1|Participant Flow|Insulin Glulisine, Then Placebo|"A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.
Insulin glulisine (5 minutes), Washout (1 week), Placebo (5 minutes)
Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)
Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)"
184326|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
184327|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
184328|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
184329|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
184330|NCT01436045|O2|Outcome|Post Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
184331|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
184332|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
184333|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
184334|NCT01436045|E1|Reported Event|All Study Partipants|Participants who received either intranasal glulisine (0.10 mL in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.
184336|NCT01436006|P1|Participant Flow|CT Scan|"A total of 65 radiology departments, with 70 MDCT scanners, collected data of 5942 adult patients, randomly chosen, who underwent to CT examinations for common clinical for 5 common different protocols including also new examination that will be in the near future common practise as cardiac CT.
A prevalence of multiphasic study was documented in many chest abdomen and pelvis (CAP) studies and abdominal studies."
184337|NCT01436006|O1|Outcome|CT Adult Spine|Adult patients submitted to spine CT
184338|NCT01436006|O1|Outcome|Adult Patient Chest Abdomen and Pelvis|Adult patients submitted to chest abdomen and pelvis CT examinations.
184339|NCT01436006|O1|Outcome|Adult Cardiac CT|Adult patients submitted to cardiac CT
184340|NCT01436006|O2|Outcome|Abdomen CT Pediatric|Pediatric patients submitted to abdomen CT
184341|NCT01436006|O1|Outcome|Abdomen CT Adults|Adult patients submitted to abdomen CT
184342|NCT01436006|O2|Outcome|Chest CT- Pediatric|Pediatric patients submitted to chest CT
184343|NCT01436006|O1|Outcome|Chest CT- Adult|Adult patients submitted to chest CT
184344|NCT01436006|O2|Outcome|Pediatric|Pediatric patients submitted to head CT scan
184345|NCT01436006|O1|Outcome|Adult|Adult patients submitted to head CT scan
184346|NCT01436006|E1|Reported Event|Adverse Reaction to CT|Patients submitted to CT
184347|NCT01435928|B3|Baseline|Total|Total of all reporting groups
184348|NCT01435928|B2|Baseline|Placebo|During double blind phase subjects received matching placebo.
184349|NCT01435928|B1|Baseline|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
184350|NCT01435928|P3|Participant Flow|Placebo|During double blind phase subjects received matching placebo.
184351|NCT01435928|P2|Participant Flow|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
184352|NCT01435928|P1|Participant Flow|All Subjects|During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
184353|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating
Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
184354|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
184355|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating
Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
184356|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
184357|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating
Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
184358|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
184359|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating
Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
184360|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
184361|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating
Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
184362|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
184363|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating
Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
184364|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
184365|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating
Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
184366|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
184367|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating
Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
184368|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
184369|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating
Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
184370|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
184371|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating
Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
184372|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
184373|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating
Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
184374|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
184375|NCT01435928|E3|Reported Event|Placebo|During double blind phase subjects received matching placebo.
184376|NCT01435928|E2|Reported Event|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
184377|NCT01435928|E1|Reported Event|All Subjects|During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
184378|NCT01435798|B1|Baseline|Dextromethorphan Dose Response Clinical Trial|Each subject received four doses of dextromethorphan; 0% (placebo), 25%, 50%, and 100% of the maximum tolerated dose in a balanced randomized order. Each dose was administered for a period of 28 days; on day 21 of each phase, subjects traveled to the study site to undergo study procedures in a nested clinical trial (not described here).
184379|NCT01435798|P1|Participant Flow|Dextromethorphan Dose Response (DDR) Clinical Trial|Each subject received four doses of dextromethorphan; 0% (placebo), 25%, 50%, and 100% of the maximum tolerated dose in a balanced randomized order. Each dose was administered for a period of 28 days; on day 21 of each phase, subjects traveled to the study site to undergo study procedures in a nested clinical trial (not described here).
184380|NCT01435798|O4|Outcome|100% MTD Dex|100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184381|NCT01435798|O3|Outcome|50% MTD Dex|50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184382|NCT01435798|O2|Outcome|25% MTD Dex|25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184383|NCT01435798|O1|Outcome|0% MTD Dex|0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184384|NCT01435798|O4|Outcome|100% MTD Dex|100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184385|NCT01435798|O3|Outcome|50% MTD Dex|50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184386|NCT01435798|O2|Outcome|25% MTD Dex|25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184387|NCT01435798|O1|Outcome|0% MTD Dex|0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184388|NCT01435798|E4|Reported Event|100% MTD Dex|100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184389|NCT01435798|E3|Reported Event|50% MTD Dex|50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184390|NCT01435798|E2|Reported Event|25% MTD Dex|25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184391|NCT01435798|E1|Reported Event|0% MTD Dex|0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
184392|NCT01435759|B6|Baseline|Total|Total of all reporting groups
184393|NCT01435759|B5|Baseline|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
184394|NCT01435759|B4|Baseline|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
184395|NCT01435759|B3|Baseline|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
184396|NCT01435759|B2|Baseline|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
184397|NCT01435759|B1|Baseline|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
184398|NCT01435759|P6|Participant Flow|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
184399|NCT01435759|P5|Participant Flow|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
184400|NCT01435759|P4|Participant Flow|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
184454|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184721|NCT01434186|O1|Outcome|Saxagliptin|Saxagliptin 2.5 mg or 5 mg according to bodyweight
184401|NCT01435759|P3|Participant Flow|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
184402|NCT01435759|P2|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
184403|NCT01435759|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily single-blind placebo (matching SPD489).
184404|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
184405|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
184406|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
184407|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
184408|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
184409|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
184410|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
184411|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
184412|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
184413|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
184414|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
184415|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
184416|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
184417|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
184418|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
184419|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
184420|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
184421|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
184422|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
184423|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
184699|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184424|NCT01435759|E5|Reported Event|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
184425|NCT01435759|E4|Reported Event|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
184426|NCT01435759|E3|Reported Event|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
184427|NCT01435759|E2|Reported Event|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
184428|NCT01435759|E1|Reported Event|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
184429|NCT01435655|B1|Baseline|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184430|NCT01435655|P1|Participant Flow|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184431|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184432|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184433|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184434|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184435|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184436|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184437|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184438|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184439|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184440|NCT01435655|E1|Reported Event|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
184441|NCT01435577|B3|Baseline|Total|Total of all reporting groups
184442|NCT01435577|B2|Baseline|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184443|NCT01435577|B1|Baseline|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
184444|NCT01435577|P2|Participant Flow|Matching Placebo Intravenous|"Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
65 Randomized participants, 65 Participants in the Safety Set (SAF), 65 Participants in the Full Analysis Set(FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment."
184445|NCT01435577|P1|Participant Flow|Tapentadol Intravenous|"Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
64 Participants Randomized, 64 Participants in the Safety Set (SAF), 64 Participants in the Full Analysis Set (FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment."
184446|NCT01435577|O1|Outcome|Matching Placebo Intravenous|Matching Placebo will be given by intravenous infusion. Matching Placebo will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
184447|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
184448|NCT01435577|O1|Outcome|Tapentadol Intravenous|Pharmacokinetic samples were taken from all participants, however only samples from the tapentadol treatment group were analyzed.
184449|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184450|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
184451|NCT01435577|O1|Outcome|Tapentadol Intravenous|Pharmacokinetic samples were taken from all participants, however only samples from the tapentadol treatment group were analyzed.
184452|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone. Values collected after 12 hours were censored, i.e. participants scored as having no meaningful pain relief.
184453|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184455|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184456|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184457|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184458|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184459|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184460|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184461|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184462|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184463|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184464|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184465|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184466|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184467|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184468|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184469|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184470|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184471|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184472|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184473|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184474|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184475|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
184476|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184477|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184478|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184479|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
184480|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184481|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
184482|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184483|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
184484|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184485|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184486|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184527|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
184487|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
184488|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184489|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
184490|NCT01435577|E2|Reported Event|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
184491|NCT01435577|E1|Reported Event|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
184492|NCT01435460|B3|Baseline|Total|Total of all reporting groups
184493|NCT01435460|B2|Baseline|Patanol|Ophthalmic solution containing olopatadine, 0.1%
184494|NCT01435460|B1|Baseline|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
184495|NCT01435460|P2|Participant Flow|Patanol|Ophthalmic solution containing olopatadine, 0.1%
184496|NCT01435460|P1|Participant Flow|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
184497|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
184498|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
184499|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
184500|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
184501|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
184502|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
184503|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
184504|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
184505|NCT01435460|E2|Reported Event|Patanol|Ophthalmic solution containing olopatadine, 0.1%
184506|NCT01435460|E1|Reported Event|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
184507|NCT01435265|B3|Baseline|Total|Total of all reporting groups
184508|NCT01435265|B2|Baseline|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
184509|NCT01435265|B1|Baseline|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
184510|NCT01435265|P2|Participant Flow|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
184511|NCT01435265|P1|Participant Flow|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
184512|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
184513|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
184514|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
184515|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
184516|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
184517|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
184518|NCT01435265|E2|Reported Event|Additional Nurse Education|Experimental: Additional Nurse Education- Subjects will receive additional nurse education beyond the normal education materials provided by their physician
184519|NCT01435265|E1|Reported Event|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
184520|NCT01435174|B1|Baseline|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets
Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.
QT Interval: Calculation of a QT interval will be performed throughout subject participation."
184521|NCT01435174|P1|Participant Flow|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets
Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.
QT Interval: Calculation of a QT interval will be performed throughout subject participation."
184522|NCT01435174|O1|Outcome|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets
Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.
QT Interval: Calculation of a QT interval will be performed throughout subject participation."
184523|NCT01435174|E1|Reported Event|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets
Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.
QT Interval: Calculation of a QT interval will be performed throughout subject participation."
184524|NCT01435122|B1|Baseline|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
184525|NCT01435122|P1|Participant Flow|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
184526|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
184530|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
184531|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
184532|NCT01435122|E1|Reported Event|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
184533|NCT01435031|B1|Baseline|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184534|NCT01435031|P1|Participant Flow|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184535|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184536|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184537|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184538|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184539|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184540|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184541|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184542|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184543|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184623|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
184544|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184545|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184546|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184547|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184548|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184549|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184550|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184551|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184552|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184553|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184554|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184555|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184692|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184556|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184557|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184558|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184559|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184560|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184561|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184562|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184563|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184564|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184565|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184566|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184567|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184693|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184568|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184569|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184570|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184571|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184572|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184573|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184574|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184575|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184576|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184577|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184578|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184579|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184694|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184580|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184581|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184582|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184583|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184584|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184585|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184586|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184587|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184588|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184589|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184590|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184591|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184695|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184592|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184593|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184594|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184595|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184596|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184597|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184598|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184599|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184600|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184601|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184602|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184603|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184696|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184604|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184605|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184606|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184607|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184608|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184609|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184610|NCT01435031|E1|Reported Event|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
HT PROGRESS and/or HT PILOT guide wires in recanalization
MINI-TREK Coronary Dilatation Catheter in predilatation"
184611|NCT01434823|B3|Baseline|Total|Total of all reporting groups
184612|NCT01434823|B2|Baseline|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
184613|NCT01434823|B1|Baseline|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
184614|NCT01434823|P2|Participant Flow|Control - Standard of Care|"The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of covered nights for each patient's ICU stay."
184615|NCT01434823|P1|Participant Flow|Intervention - Nocturnal Coverage|"Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of covered nights for each patient's ICU stay in secondary analyses."
184616|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
184617|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
184618|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
184619|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
184620|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
184621|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
184622|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
184624|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
184625|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
184626|NCT01434823|E2|Reported Event|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
184627|NCT01434823|E1|Reported Event|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
184628|NCT01434693|B5|Baseline|Total|Total of all reporting groups
184629|NCT01434693|B4|Baseline|TSO 7500|Trichuris suis ova : single dose
184630|NCT01434693|B3|Baseline|TSO 2500|Trichuris suis ova : single dose
184631|NCT01434693|B2|Baseline|TSO 500|Trichuris suis ova : single dose
184632|NCT01434693|B1|Baseline|Placebo|Placebo: single dose
184633|NCT01434693|P4|Participant Flow|TSO 7500|Trichuris suis ova : single dose
184634|NCT01434693|P3|Participant Flow|TSO 2500|Trichuris suis ova : single dose
184635|NCT01434693|P2|Participant Flow|TSO 500|Trichuris suis ova : single dose
184636|NCT01434693|P1|Participant Flow|Placebo|Placebo: single dose
184637|NCT01434693|O4|Outcome|TSO 7500|Trichuris suis ova : single dose
184638|NCT01434693|O3|Outcome|TSO 2500|Trichuris suis ova : single dose
184639|NCT01434693|O2|Outcome|TSO 500|Trichuris suis ova : single dose
184640|NCT01434693|O1|Outcome|Placebo|Placebo: single dose
184641|NCT01434693|E4|Reported Event|TSO 7500|Trichuris suis ova : single dose
184642|NCT01434693|E3|Reported Event|TSO 2500|Trichuris suis ova : single dose
184643|NCT01434693|E2|Reported Event|TSO 500|Trichuris suis ova : single dose
184644|NCT01434693|E1|Reported Event|Placebo|Placebo: single dose
184645|NCT01434680|B5|Baseline|Total|Total of all reporting groups
184646|NCT01434680|B4|Baseline|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
184647|NCT01434680|B3|Baseline|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
184648|NCT01434680|B2|Baseline|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
184649|NCT01434680|B1|Baseline|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
184650|NCT01434680|P4|Participant Flow|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
184651|NCT01434680|P3|Participant Flow|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
184652|NCT01434680|P2|Participant Flow|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
184653|NCT01434680|P1|Participant Flow|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
184654|NCT01434680|O4|Outcome|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
184655|NCT01434680|O3|Outcome|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
184656|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
184657|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
184658|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
184659|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
184660|NCT01434680|O3|Outcome|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
184661|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
184662|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
184663|NCT01434680|E4|Reported Event|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
184664|NCT01434680|E3|Reported Event|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
184665|NCT01434680|E2|Reported Event|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
184666|NCT01434680|E1|Reported Event|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
184667|NCT01434654|B3|Baseline|Total|Total of all reporting groups
184668|NCT01434654|B2|Baseline|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184669|NCT01434654|B1|Baseline|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184697|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184670|NCT01434654|P2|Participant Flow|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184671|NCT01434654|P1|Participant Flow|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184672|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184673|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184674|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184675|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184676|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184677|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184678|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184679|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184680|NCT01434654|E2|Reported Event|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184681|NCT01434654|E1|Reported Event|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
184682|NCT01434641|B1|Baseline|Myocardial Perfusion SPECT|The 102 study patients underwent a very low-activity stress/high-activity rest, single-day myocardial perfusion SPECT ith a conventional sodium iodide camera and wide beam reconstruction processing.
184683|NCT01434641|P1|Participant Flow|Stress/Rest Myocardial Perfusion SPECT Patients|All patients referred for clinically indicated myocardial perfusion SPECT are eligible candidates for this protocol. Low-dose stress/high-dose rest myocardial perfusion SPECT is performed according to the protocol and image quality and rest/stress myocardial count density ratios are assessed.
184684|NCT01434641|O1|Outcome|Myocardial Perfusion SPECT|Participants underwent novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
184685|NCT01434641|O1|Outcome|Myocardial Perfusion SPECT|Participants underwent novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
184686|NCT01434641|E1|Reported Event|Myocardial Perfusion SPECT|
184687|NCT01434511|B1|Baseline|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184688|NCT01434511|P1|Participant Flow|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184689|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184690|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184691|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184700|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184701|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184702|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184703|NCT01434511|E1|Reported Event|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
184704|NCT01434342|B3|Baseline|Total|Total of all reporting groups
184705|NCT01434342|B2|Baseline|Arm II|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
184706|NCT01434342|B1|Baseline|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.
Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
184707|NCT01434342|P2|Participant Flow|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
184708|NCT01434342|P1|Participant Flow|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.
Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
184709|NCT01434342|O2|Outcome|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
184710|NCT01434342|O1|Outcome|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff.
The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients.
Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period.
Participants also learn behavioral tips and coping skills."
184711|NCT01434342|O2|Outcome|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
184712|NCT01434342|O1|Outcome|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff.
The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients.
Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period.
Participants also learn behavioral tips and coping skills."
184713|NCT01434342|E2|Reported Event|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
184714|NCT01434342|E1|Reported Event|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.
Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
184715|NCT01434186|B3|Baseline|Total|Total of all reporting groups
184716|NCT01434186|B2|Baseline|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
184717|NCT01434186|B1|Baseline|Placebo|Placebo matching saxagliptin
184718|NCT01434186|P2|Participant Flow|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
184722|NCT01434186|E2|Reported Event|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
184723|NCT01434186|E1|Reported Event|Placebo|Placebo matching saxagliptin
184724|NCT01434121|B4|Baseline|Total|Total of all reporting groups
184725|NCT01434121|B3|Baseline|Placebo|"Subject receives an infusion of saline
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184726|NCT01434121|B2|Baseline|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184727|NCT01434121|B1|Baseline|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184728|NCT01434121|P3|Participant Flow|Placebo|"Subject receives an infusion of saline
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184729|NCT01434121|P2|Participant Flow|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184730|NCT01434121|P1|Participant Flow|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184731|NCT01434121|O3|Outcome|Placebo|"Subject receives an infusion of saline
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184732|NCT01434121|O2|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184733|NCT01434121|O1|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184734|NCT01434121|E3|Reported Event|Placebo|"Subject receives an infusion of saline
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184735|NCT01434121|E2|Reported Event|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184736|NCT01434121|E1|Reported Event|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C
Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
184737|NCT01434030|B1|Baseline|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
184738|NCT01434030|P1|Participant Flow|Behavioral Observer|Focus group methodology was chosen to obtain qualitative and quantitative data on participants’ desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
184739|NCT01434030|O1|Outcome|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
184740|NCT01434030|O1|Outcome|Behavioral Observer|Focus group methodology was chosen to obtain qualitative and quantitative data on participants’ desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
184741|NCT01434030|E1|Reported Event|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
184742|NCT01433913|B3|Baseline|Total|Total of all reporting groups
184743|NCT01433913|B2|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
184845|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
184846|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
184744|NCT01433913|B1|Baseline|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.
metformin hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies"
184745|NCT01433913|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
184746|NCT01433913|P1|Participant Flow|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.
metformin hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies"
184747|NCT01433913|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
184748|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.
metformin hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies"
184749|NCT01433913|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
184750|NCT01433913|E1|Reported Event|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.
metformin hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies"
184751|NCT01433731|B5|Baseline|Total|Total of all reporting groups
184752|NCT01433731|B4|Baseline|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
184753|NCT01433731|B3|Baseline|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
184754|NCT01433731|B2|Baseline|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
184755|NCT01433731|B1|Baseline|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gel
184756|NCT01433731|P4|Participant Flow|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
184757|NCT01433731|P3|Participant Flow|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
184758|NCT01433731|P2|Participant Flow|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
184759|NCT01433731|P1|Participant Flow|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gelled solution
184760|NCT01433731|O2|Outcome|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gel
184761|NCT01433731|O1|Outcome|SHAPE (SHP-141)|"Histone deacetylase inhibitor
SHAPE (SHP-141): topical gel"
184762|NCT01433731|E4|Reported Event|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
184763|NCT01433731|E3|Reported Event|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
184764|NCT01433731|E2|Reported Event|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
184765|NCT01433731|E1|Reported Event|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gelled solution
184766|NCT01433549|B1|Baseline|Overall|Lotrafilcon B and Senofilcon A worn in cross-over fashion as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
184767|NCT01433549|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
184768|NCT01433549|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
184769|NCT01433549|O2|Outcome|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
184770|NCT01433549|O1|Outcome|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
184771|NCT01433549|O2|Outcome|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
184772|NCT01433549|O1|Outcome|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
184773|NCT01433549|E2|Reported Event|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
184774|NCT01433549|E1|Reported Event|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
184775|NCT01433471|B3|Baseline|Total|Total of all reporting groups
184776|NCT01433471|B2|Baseline|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184777|NCT01433471|B1|Baseline|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184778|NCT01433471|P2|Participant Flow|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184779|NCT01433471|P1|Participant Flow|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184780|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184781|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184782|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184783|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184784|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184785|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184786|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184787|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184788|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184789|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover
Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
184790|NCT01433471|O2|Outcome|Placebo|
184791|NCT01433471|O1|Outcome|Trichuris Suis Ova|
184792|NCT01433471|E2|Reported Event|Placebo|
184793|NCT01433471|E1|Reported Event|Trichuris Suis Ova|
184794|NCT01433354|B1|Baseline|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals.
184795|NCT01433354|P1|Participant Flow|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals.
184796|NCT01433354|O6|Outcome|AFQ056 100 mg Bid|
184797|NCT01433354|O5|Outcome|AFQ056 75 mg Bid|
184798|NCT01433354|O4|Outcome|AFQ056 50 mg Bid|
184799|NCT01433354|O3|Outcome|AFQ056 25 mg Bid|
184800|NCT01433354|O2|Outcome|Prior to Ext. First Dose|
184801|NCT01433354|O1|Outcome|AFQ056|Total
184802|NCT01433354|E6|Reported Event|Total|Total
184803|NCT01433354|E5|Reported Event|AFQ056 100 mg Bid|AFQ056 100 mg bid
184804|NCT01433354|E4|Reported Event|AFQ056 75 mg Bid|AFQ056 75 mg bid
184805|NCT01433354|E3|Reported Event|AFQ056 50 mg Bid|AFQ056 50 mg bid
184806|NCT01433354|E2|Reported Event|AFQ056 25 mg Bid|AFQ056 25 mg bid
184807|NCT01433354|E1|Reported Event|Prior to Ext.First Dose|Prior to Ext.first dose
184808|NCT01433263|B3|Baseline|Total|Total of all reporting groups
184809|NCT01433263|B2|Baseline|Placebo / Late 30mg/kg BYM338|
184810|NCT01433263|B1|Baseline|30mg/kg BYM338|
184811|NCT01433263|P2|Participant Flow|Placebo / Late 30mg/kg BYM338|
184812|NCT01433263|P1|Participant Flow|30mg/kg BYM338|
184813|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
184814|NCT01433263|O1|Outcome|30mg/kg BYM338|
184815|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
184816|NCT01433263|O1|Outcome|30mg/kg BYM338|
184817|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
184818|NCT01433263|O1|Outcome|30mg/kg BYM338|
184819|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
184820|NCT01433263|O1|Outcome|30mg/kg BYM338|
184821|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
184822|NCT01433263|O1|Outcome|30mg/kg BYM338|
184823|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
184824|NCT01433263|O1|Outcome|30mg/kg BYM338|
184825|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
184826|NCT01433263|O1|Outcome|30mg/kg BYM338|
184827|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
184828|NCT01433263|O1|Outcome|30mg/kg BYM338|
184829|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
184830|NCT01433263|O1|Outcome|30mg/kg BYM338|
184831|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
184832|NCT01433263|O1|Outcome|30mg/kg BYM338|
184833|NCT01433263|E5|Reported Event|Follow-up - 30mg/kg BYM338 Late|Follow-up - 30mg/kg BYM338 Late
184834|NCT01433263|E4|Reported Event|Follow-up - Placebo|Follow-up - Placebo
184835|NCT01433263|E3|Reported Event|Follow-up - 30mg/kg BYM338|Follow-up - 30mg/kg BYM338
184836|NCT01433263|E2|Reported Event|Core - Placebo|Core - Placebo
184837|NCT01433263|E1|Reported Event|Core - 30mg/kg BYM338|Core - 30mg/kg BYM338
184838|NCT01433250|B3|Baseline|Total|Total of all reporting groups
184839|NCT01433250|B2|Baseline|Placebo/AIN457|Placebo for core study and AIN in extension study
184840|NCT01433250|B1|Baseline|AIN457/ AIN457|AIN in core study , continued AIN in extension study
184841|NCT01433250|P2|Participant Flow|AIN Placebo/ AIN457 Extension|"Placebo in core study and AIN in extension study
(10 mg/kg iv every four weeks)"
184842|NCT01433250|P1|Participant Flow|AIN457 Core / AIN457 Extension|AIN in core study , continued AIN in extension study ( 10 mg/Kg iv every four weeks)
184843|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
184844|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
184847|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
184848|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
184849|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
184850|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
184851|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
184852|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
184853|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
184854|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
184855|NCT01433250|E2|Reported Event|AIN457(Core)/AIN457(Extension)|AIN457(core)/AIN457(extension)
184856|NCT01433250|E1|Reported Event|Placebo(Core)/AIN457(Extension)|Placebo(core)/AIN457(extension)
184857|NCT01433172|B4|Baseline|Total|Total of all reporting groups
184858|NCT01433172|B3|Baseline|Phase II Arm B Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
184859|NCT01433172|B2|Baseline|Phase II Arm A Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
184860|NCT01433172|B1|Baseline|Phase I Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
184861|NCT01433172|P3|Participant Flow|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Phase II Arm B: Participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
184862|NCT01433172|P2|Participant Flow|Phase II Arm A GM.CD40L Cells Vaccinations|Phase II Arm A: Participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
184863|NCT01433172|P1|Participant Flow|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note for the phase I portion: the use of steroid medication is to be avoided for 4 weeks prior to the initiation of vaccine therapy and during the vaccine treatment period.
184864|NCT01433172|O2|Outcome|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
184865|NCT01433172|O1|Outcome|Phase II Arm A GM.CD40L Cells Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
184866|NCT01433172|O2|Outcome|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
184867|NCT01433172|O1|Outcome|Phase II Arm A GM.CD40L Cells Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
184868|NCT01433172|O1|Outcome|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
184869|NCT01433172|E3|Reported Event|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
184870|NCT01433172|E2|Reported Event|Phase II Arm A GM.CD40L Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
184871|NCT01433172|E1|Reported Event|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
184872|NCT01433159|B3|Baseline|Total|Total of all reporting groups
184873|NCT01433159|B2|Baseline|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
184874|NCT01433159|B1|Baseline|HP011-101|Xenaderm Ointment
184875|NCT01433159|P2|Participant Flow|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
184876|NCT01433159|P1|Participant Flow|HP011-101|Xenaderm Ointment
184877|NCT01433159|O2|Outcome|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT-containing products
184878|NCT01433159|O1|Outcome|HP011-101|Xenaderm Ointment
184879|NCT01433159|E2|Reported Event|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
184880|NCT01433159|E1|Reported Event|HP011-101|Xenaderm Ointment
184881|NCT01433107|B3|Baseline|Total|Total of all reporting groups
184882|NCT01433107|B2|Baseline|Placebo|Drug
184883|NCT01433107|B1|Baseline|Terbinafine|Drug
184884|NCT01433107|P2|Participant Flow|Placebo|Drug
184885|NCT01433107|P1|Participant Flow|Terbinafine|Drug
184886|NCT01433107|O2|Outcome|Placebo|Drug
184887|NCT01433107|O1|Outcome|Terbinafine|Drug
184888|NCT01433107|O2|Outcome|Placebo|Drug
184889|NCT01433107|O1|Outcome|Terbinafine|Drug
184890|NCT01433107|O2|Outcome|Placebo|Drug
184891|NCT01433107|O1|Outcome|Terbinafine|Drug
184892|NCT01433107|E2|Reported Event|Placebo|Drug
184893|NCT01433107|E1|Reported Event|Terbinafine|Drug
184894|NCT01433081|B3|Baseline|Total|Total of all reporting groups
184895|NCT01433081|B2|Baseline|Placebo|.9 normal saline infusion
184896|NCT01433081|B1|Baseline|Magnesium Sulfate Infusion|Administration of magnesium suflate
184897|NCT01433081|P2|Participant Flow|Placebo|Normal saline infusion
184898|NCT01433081|P1|Participant Flow|Magnesium Sulfate Infusion|Administration of magnesium suflate
184899|NCT01433081|O2|Outcome|Placebo|.9 normal saline infusion
184900|NCT01433081|O1|Outcome|Magnesium Sulfate Infusion|Administration of magnesium suflate
184901|NCT01433081|O2|Outcome|Placebo|Normal saline infusion
184902|NCT01433081|O1|Outcome|Magnesium Sulfate Infusion|Administration of magnesium suflate
184903|NCT01433081|E2|Reported Event|Placebo|.9 normal saline infusion
184904|NCT01433081|E1|Reported Event|Magnesium Sulfate Infusion|Administration of magnesium suflate
184905|NCT01433055|B3|Baseline|Total|Total of all reporting groups
184906|NCT01433055|B2|Baseline|Sugar Pill|"Placebo: Placebo Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184907|NCT01433055|B1|Baseline|Minocycline|"Minocycline: Minocycline Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184908|NCT01433055|P2|Participant Flow|Sugar Pill|"Placebo: Placebo Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184909|NCT01433055|P1|Participant Flow|Minocycline|"Minocycline: Minocycline Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184910|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184911|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184912|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184913|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184914|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184959|NCT01432756|B3|Baseline|Wait-list Control - Adolescent Participants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
186153|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients
Placebo: Placebo comparator"
184915|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184916|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184917|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184918|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184919|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184920|NCT01433055|E2|Reported Event|Sugar Pill|"Placebo: Placebo Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184921|NCT01433055|E1|Reported Event|Minocycline|"Minocycline: Minocycline Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
184922|NCT01433042|B1|Baseline|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
184923|NCT01433042|P1|Participant Flow|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
184924|NCT01433042|O1|Outcome|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
184925|NCT01433042|E1|Reported Event|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
184926|NCT01433016|B1|Baseline|Suspected HCC|Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
184927|NCT01433016|P1|Participant Flow|Suspected HCC|Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
184928|NCT01433016|O1|Outcome|Suspected HCC|Subjects at high risk for Hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease
184929|NCT01433016|E1|Reported Event|Suspected HCC|Subjects at high risk for Hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease
184930|NCT01432938|B1|Baseline|Entire Study Population|Participants who received at least one dose of study drug (dulaglutide or warfarin).
184993|NCT01432600|E4|Reported Event|D: Crossover Arm|Phase II: Participants who crossed over from Arm B to Arm D.
184931|NCT01432938|P2|Participant Flow|Dulaglutide + Warfarin First, Then Warfarin|"First Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2).
There was a washout period of at least 24 days between intervention periods.
Second Intervention: A single, 10-mg dose of warfarin administered orally on Day 1 (Treatment 1)."
184932|NCT01432938|P1|Participant Flow|Warfarin First, Then Dulaglutide + Warfarin|"First Intervention: A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 (Treatment 1).
There was a washout period of at least 24 days between treatment periods.
Second Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2)."
184933|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
184934|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
184935|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
184936|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
184937|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
184938|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
184939|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
184940|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
184941|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
184942|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
184943|NCT01432938|E3|Reported Event|Dulaglutide + Warfarin|"A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2
Timeframe: After dosing of warfarin on Day 3 of Treatment 2"
184944|NCT01432938|E2|Reported Event|Dulaglutide Alone|"A single, 1.5-mg dose administered subcutaneously on Day 1 of Treatment 2.
Timeframe: Day 1 to Day 3 before dosing of warfarin in Treatment 2"
184945|NCT01432938|E1|Reported Event|Warfarin Alone|"A single, 10-milligram (mg) dose administered orally on Day 1 of Treatment 1.
Timeframe: Treatment 1"
184946|NCT01432886|B3|Baseline|Total|Total of all reporting groups
184947|NCT01432886|B2|Baseline|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
184948|NCT01432886|B1|Baseline|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
184949|NCT01432886|P2|Participant Flow|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
184950|NCT01432886|P1|Participant Flow|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
184951|NCT01432886|O2|Outcome|E7389 With Triweekly Trastuzumab|"Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle.
Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses."
184952|NCT01432886|O1|Outcome|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
184953|NCT01432886|O2|Outcome|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
184954|NCT01432886|O1|Outcome|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
184955|NCT01432886|E2|Reported Event|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
184956|NCT01432886|E1|Reported Event|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
184957|NCT01432756|B5|Baseline|Total|Total of all reporting groups
184958|NCT01432756|B4|Baseline|Let's Talk Worksite Parenting Program -Adolescent Participants|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.
The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
184960|NCT01432756|B2|Baseline|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.
Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
184961|NCT01432756|B1|Baseline|Wait-list Control - Parent Participants|Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
184962|NCT01432756|P4|Participant Flow|Let's Talk Worksite Parenting Program - Adolescent Participant|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.
The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
184963|NCT01432756|P3|Participant Flow|Wait-list Control - Adolescent Partipants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
184964|NCT01432756|P2|Participant Flow|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.
Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
184965|NCT01432756|P1|Participant Flow|Wait-list Control - Parent Participants|Parent participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
184966|NCT01432756|O4|Outcome|Let's Talk Worksite Parenting Program -Adolescent Participants|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.
The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
184967|NCT01432756|O3|Outcome|Wait-list Control - Adolescent Participants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
184968|NCT01432756|O2|Outcome|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.
Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
184969|NCT01432756|O1|Outcome|Wait-list Control - Parent Participants|Parent participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
184970|NCT01432756|E2|Reported Event|Let's Talk Worskite Parenting Program|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.
Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
184971|NCT01432756|E1|Reported Event|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
184991|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.
Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Arm D participants may be referenced separately in some Outcome Measures."
184992|NCT01432600|O1|Outcome|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
184972|NCT01432626|B1|Baseline|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.
I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
184973|NCT01432626|P1|Participant Flow|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.
I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
184974|NCT01432626|O1|Outcome|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.
I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
184975|NCT01432626|E1|Reported Event|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.
I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
184976|NCT01432600|B4|Baseline|Total|Total of all reporting groups
184977|NCT01432600|B3|Baseline|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
184978|NCT01432600|B2|Baseline|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.
Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Arm D participants may be referenced separately in some Outcome Measures."
184979|NCT01432600|B1|Baseline|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
184980|NCT01432600|P3|Participant Flow|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
184981|NCT01432600|P2|Participant Flow|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.
Arm D participants may be referenced separately in some Outcome Measures."
184982|NCT01432600|P1|Participant Flow|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
184983|NCT01432600|O3|Outcome|D: Crossover Arm|Phase II: Participants who crossed over from Arm B to Arm D. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
184984|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
184985|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.
Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Arm D participants may be referenced separately in some Outcome Measures."
184986|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
184987|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.
Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Arm D participants may be referenced separately in some Outcome Measures."
184988|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
184989|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.
Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Arm D participants may be referenced separately in some Outcome Measures."
184990|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
184994|NCT01432600|E3|Reported Event|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
184995|NCT01432600|E2|Reported Event|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.
Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Arm D participants may be referenced separately in some Outcome Measures."
184996|NCT01432600|E1|Reported Event|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
184997|NCT01432574|B1|Baseline|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.
Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
184998|NCT01432574|P1|Participant Flow|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.
Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
184999|NCT01432574|O2|Outcome|Gardasil Vaccine - Month 7|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.
Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
185000|NCT01432574|O1|Outcome|Gardasil Vaccine - Day 1|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.
Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
185001|NCT01432574|O1|Outcome|Gardasil Vaccine - Month 7|
185002|NCT01432574|E1|Reported Event|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.
Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
185003|NCT01432561|B1|Baseline|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.
Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
185004|NCT01432561|P1|Participant Flow|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.
Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
185005|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
185006|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
185007|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
185008|NCT01432561|E1|Reported Event|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.
Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
185009|NCT01432535|B4|Baseline|Total|Total of all reporting groups
185010|NCT01432535|B3|Baseline|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185011|NCT01432535|B2|Baseline|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185012|NCT01432535|B1|Baseline|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185013|NCT01432535|P3|Participant Flow|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185014|NCT01432535|P2|Participant Flow|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185015|NCT01432535|P1|Participant Flow|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185016|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185017|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185018|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185019|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185020|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185021|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185049|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
185317|NCT01431703|B1|Baseline|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
185022|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185023|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185024|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185025|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185026|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185027|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185028|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185029|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185030|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185031|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185032|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185033|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185034|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185035|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185036|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185037|NCT01432535|E3|Reported Event|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185038|NCT01432535|E2|Reported Event|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185039|NCT01432535|E1|Reported Event|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
185040|NCT01432457|B4|Baseline|Total|Total of all reporting groups
185041|NCT01432457|B3|Baseline|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
185042|NCT01432457|B2|Baseline|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
185043|NCT01432457|B1|Baseline|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
185044|NCT01432457|P3|Participant Flow|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
185045|NCT01432457|P2|Participant Flow|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
185046|NCT01432457|P1|Participant Flow|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
185047|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
185048|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
185388|NCT01431300|O1|Outcome|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
185050|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
185051|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
185052|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
185053|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
185054|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
185055|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
185056|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
185057|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
185058|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
185059|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
185060|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
185061|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
185062|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
185063|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
185064|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
185065|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
185066|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
185067|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
185068|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
185069|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
185070|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
185071|NCT01432457|E3|Reported Event|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
185072|NCT01432457|E2|Reported Event|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
185073|NCT01432457|E1|Reported Event|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
185074|NCT01432444|B1|Baseline|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
185075|NCT01432444|P3|Participant Flow|Extension Phase (Phase C)|Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believes would receive benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
186710|NCT01426789|P6|Participant Flow|Group 4|Part 1: placebo; Part 2: no study treatment
185076|NCT01432444|P2|Participant Flow|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
185077|NCT01432444|P1|Participant Flow|Tolerability/Cross-titration Phase (Phase A)|In Phase A, participants who had no history of tolerating oral aripiprazole entered a Tolerability Assessment/Cross-titration Phase in order to assess tolerability to oral aripiprazole. The recommended initial dose of oral aripiprazole in the Tolerability Assessment/Cross-titration Phase was 10 mg or 15 mg/day, depending on the participant's symptoms and the study physician's judgment. Participants were seen in the clinic at baseline and weekly thereafter for a minimum of 1 week and maximum of 4 weeks/28 days, until tolerability to oral aripiprazole had been determined, based on physician's discretion, or until the participant was terminated from the study.
185078|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
185079|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
185080|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
185081|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
185082|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
185083|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
185084|NCT01432444|E2|Reported Event|Extension Phase (Phase C)|Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believed would benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
185085|NCT01432444|E1|Reported Event|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
185086|NCT01432405|B3|Baseline|Total|Total of all reporting groups
185117|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185087|NCT01432405|B2|Baseline|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months
Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
185088|NCT01432405|B1|Baseline|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.
Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
185089|NCT01432405|P2|Participant Flow|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months
Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
185090|NCT01432405|P1|Participant Flow|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.
Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
185091|NCT01432405|O2|Outcome|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months
Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
185092|NCT01432405|O1|Outcome|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.
Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
185093|NCT01432405|O2|Outcome|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months
Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
185094|NCT01432405|O1|Outcome|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.
Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
185095|NCT01432405|E2|Reported Event|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months
Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
185118|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185096|NCT01432405|E1|Reported Event|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.
Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
185097|NCT01432379|B1|Baseline|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
185098|NCT01432379|P1|Participant Flow|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
185099|NCT01432379|O1|Outcome|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
185100|NCT01432379|O1|Outcome|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
185101|NCT01432379|E1|Reported Event|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
185102|NCT01432366|B1|Baseline|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185103|NCT01432366|P1|Participant Flow|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185104|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185105|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185106|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185107|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185108|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185109|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185110|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185111|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185112|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185113|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185114|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185115|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185116|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
187500|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
185119|NCT01432366|E1|Reported Event|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
185120|NCT01432327|B5|Baseline|Total|Total of all reporting groups
185121|NCT01432327|B4|Baseline|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
185122|NCT01432327|B3|Baseline|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
185123|NCT01432327|B2|Baseline|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
185124|NCT01432327|B1|Baseline|Control Group|This group receives no kind of feedback during the intervention period
185125|NCT01432327|P4|Participant Flow|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
185126|NCT01432327|P3|Participant Flow|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
185127|NCT01432327|P2|Participant Flow|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
185128|NCT01432327|P1|Participant Flow|Control Group|This group receives no kind of feedback during the intervention period
185129|NCT01432327|O4|Outcome|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
185130|NCT01432327|O3|Outcome|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
185131|NCT01432327|O2|Outcome|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
185132|NCT01432327|O1|Outcome|Control Group|This group receives no kind of feedback during the intervention period
185133|NCT01432327|E4|Reported Event|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
185134|NCT01432327|E3|Reported Event|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
185135|NCT01432327|E2|Reported Event|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
185136|NCT01432327|E1|Reported Event|Control Group|This group receives no kind of feedback during the intervention period
185137|NCT01432275|B1|Baseline|Per Protocol Population|Subjects who completed the study.
185138|NCT01432275|P2|Participant Flow|Comparator, Then ADC, Then ADC With Calculator|Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
185139|NCT01432275|P1|Participant Flow|ADC, Then Comparator, Then ADC With Calculator|Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
185140|NCT01432275|O1|Outcome|Per Protocol Population|Subjects completing the study using the FreeStyle InsuLinx Blood Glucose Meter and one of the comparator blood glucose meters
185141|NCT01432275|O1|Outcome|Per Protocol Population|Subjects completing the study using the FreeStyle InsuLinx Blood Glucose Meter and one of the comparator blood glucose meters
185142|NCT01432275|E3|Reported Event|ADC Blood Glucose Meter With Calculator|ADC blood glucose meter for 10 days with the insulin calculator active.
185143|NCT01432275|E2|Reported Event|Comparator Blood Glucose Meter|Comparator blood glucose meter for 7 days.
185144|NCT01432275|E1|Reported Event|ADC Blood Glucose Meter|ADC blood glucose meter for 7 days with the insulin calculator not activated.
185145|NCT01432262|B3|Baseline|Total|Total of all reporting groups
185146|NCT01432262|B2|Baseline|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
185147|NCT01432262|B1|Baseline|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
185148|NCT01432262|P2|Participant Flow|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
185149|NCT01432262|P1|Participant Flow|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
185150|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
185151|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
185152|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
185153|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
185154|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
185155|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
187501|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
185156|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
185157|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
185158|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
185159|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
185160|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
185161|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
185162|NCT01432262|E2|Reported Event|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
185163|NCT01432262|E1|Reported Event|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
185164|NCT01432236|B3|Baseline|Total|Total of all reporting groups
185165|NCT01432236|B2|Baseline|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185166|NCT01432236|B1|Baseline|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185167|NCT01432236|P2|Participant Flow|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185168|NCT01432236|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185169|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
185170|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
185171|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
185172|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185173|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185174|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185175|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185176|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185240|NCT01431989|E2|Reported Event|Reference Product in Period 1 and Test Product in Period 2|Reference product: Amoxil 500 mg/5 mL in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product: Clamoxyl 500 mg/5 mL in Period 2
185177|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185178|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185179|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185180|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185181|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185182|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185183|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185184|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185185|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185186|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185187|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185188|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185200|NCT01432236|O2|Outcome|Placebo|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185189|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185190|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185191|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185192|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185193|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185194|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185195|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185196|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185197|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185198|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185199|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185235|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185236|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185237|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185201|NCT01432236|O1|Outcome|Pregabalin|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185202|NCT01432236|O2|Outcome|Placebo|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185203|NCT01432236|O1|Outcome|Pregabalin|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185204|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185205|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185206|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process in period 2. There was a 2-week single-blind taper/washout period between treatment periods
185207|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185208|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185209|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185210|NCT01432236|E2|Reported Event|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
185211|NCT01432236|E1|Reported Event|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
185212|NCT01432015|B3|Baseline|Total|Total of all reporting groups
185213|NCT01432015|B2|Baseline|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.
aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
185238|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185239|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185318|NCT01431703|P1|Participant Flow|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
185214|NCT01432015|B1|Baseline|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1
Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3
fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
185215|NCT01432015|P2|Participant Flow|Aprepitant and Placebo|Aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo on day 1 and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications on day 1.
185216|NCT01432015|P1|Participant Flow|Fosaprepitant and Placebo|Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3. Patient will receive standard pre-medications on day 1
185217|NCT01432015|O2|Outcome|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.
aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
185218|NCT01432015|O1|Outcome|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1
Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3
fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
185219|NCT01432015|O2|Outcome|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.
aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
185220|NCT01432015|O1|Outcome|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1
Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3
fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
185221|NCT01432015|E2|Reported Event|Aprepitant and Placebo|Aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo on day 1 and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications on day 1.
185222|NCT01432015|E1|Reported Event|Fosaprepitant and Placebo|Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1
185223|NCT01431989|B1|Baseline|Participants Receiving Both Test and Reference Products|Participants receiving either test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2 or reference product in Period 1 and test product inPeriod 2
185224|NCT01431989|P2|Participant Flow|Reference Product in Period 1: Test Product in Period 2|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 2
185225|NCT01431989|P1|Participant Flow|Test Product in Period 1: Reference Product in Period 2|Test product, Amoxicillin (Clamoxyl) 500 milligrams (mg)/5 milliliter (mL) powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2
185226|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185227|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185228|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185229|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185230|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185231|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185232|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185233|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185234|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
185241|NCT01431989|E1|Reported Event|Test Product in Period 1 and Reference Product in Period 2|Test product: Amoxicillin powder for oral suspension (Clamoxyl) 500 mg/5 mL in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product; Amoxil 50 mg/5 mL in Period 2
185242|NCT01431976|B1|Baseline|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
185243|NCT01431976|P1|Participant Flow|Lamotrigine|In the EP, lamotrigine 0.3 milligrams per kilogram per day (mg/kg/day) was administered orally once daily from Week W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, whichever was less (WWL), until a seizure-free (SF) status was confirmed by hyperventilation (HV)-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
185244|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
185245|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
185246|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
185247|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
185248|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
185291|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
185319|NCT01431703|O1|Outcome|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
187502|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
185249|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
185250|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
185251|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
185252|NCT01431976|E1|Reported Event|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at &gt;=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose &lt;1.2 mg/kg/day or &gt;10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
185253|NCT01431963|B1|Baseline|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
185254|NCT01431963|P1|Participant Flow|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
185255|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
185256|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
185257|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
185258|NCT01431963|E1|Reported Event|Lamotrigine|In the EP, lamotrigine 25 mg/day was orally administered QD; in the evening(PM) as the initial dose from W1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD(in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, Lamotrigine 200 mg/day was orally administered QD(PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at greater than or equal to 1 week intervals. A dose greater than 200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose less than 100 or greater than 400 mg/day was judged to be necessary, the participant was withdrawn from the study.
185259|NCT01431950|B3|Baseline|Total|Total of all reporting groups
185260|NCT01431950|B2|Baseline|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185261|NCT01431950|B1|Baseline|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185262|NCT01431950|P2|Participant Flow|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185263|NCT01431950|P1|Participant Flow|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185264|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185265|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185266|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185267|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185268|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185269|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185270|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185271|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185272|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185273|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185274|NCT01431950|E2|Reported Event|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185275|NCT01431950|E1|Reported Event|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
185276|NCT01431846|B4|Baseline|Total|Total of all reporting groups
185292|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
185277|NCT01431846|B3|Baseline|Arm 3|"Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical att"
185278|NCT01431846|B2|Baseline|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
185279|NCT01431846|B1|Baseline|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
185280|NCT01431846|P3|Participant Flow|Arm 3|Informed by interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
185281|NCT01431846|P2|Participant Flow|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
185282|NCT01431846|P1|Participant Flow|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
185283|NCT01431846|O3|Outcome|Arm 3|Informed by interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2)medications reconciled between pre and post-hospital discharge; 3)discharge summary available to PCP at time of visit; and 4)patient awareness of symptoms that require medical attention Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
185284|NCT01431846|O2|Outcome|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
185285|NCT01431846|O1|Outcome|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
185286|NCT01431846|E3|Reported Event|Intervention|Total number at risk was 8. Zero adverse events were seen.
185287|NCT01431846|E2|Reported Event|Providers|Total number at risk was 3. Zero adverse events were seen.
185288|NCT01431846|E1|Reported Event|Discharged Patients|Total number at risk was 8. Zero adverse events were seen.
185289|NCT01431755|B1|Baseline|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended
185290|NCT01431755|P1|Participant Flow|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
187503|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
185293|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
185294|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
185295|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
185296|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
185297|NCT01431755|E3|Reported Event|Restylane SubQ Lidocaine: Localized|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
185298|NCT01431755|E2|Reported Event|Restylane SubQ: Localized|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
185299|NCT01431755|E1|Reported Event|Restylane SubQ/Restylane SubQ Lidocaine: Systemic|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time.
185300|NCT01431716|B1|Baseline|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185301|NCT01431716|P1|Participant Flow|Epoprostenol for Injection (EFI/ACT-385781A)|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185302|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185303|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185304|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185305|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185306|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185307|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185308|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185309|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185310|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185311|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185312|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185313|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185314|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185315|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185316|NCT01431716|E1|Reported Event|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
185320|NCT01431703|E1|Reported Event|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
185321|NCT01431521|B5|Baseline|Total|Total of all reporting groups
185322|NCT01431521|B4|Baseline|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
185323|NCT01431521|B3|Baseline|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
185324|NCT01431521|B2|Baseline|Placebo for MK-4074|Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks.
185325|NCT01431521|B1|Baseline|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
185326|NCT01431521|P4|Participant Flow|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
185327|NCT01431521|P3|Participant Flow|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
185328|NCT01431521|P2|Participant Flow|Placebo for MK-4074|Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks.
185329|NCT01431521|P1|Participant Flow|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
185330|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
185331|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
185332|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
185333|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
185334|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
185335|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
185336|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
185337|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
185338|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
185339|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
185340|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
185341|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
185342|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
185343|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
185344|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
185345|NCT01431521|E4|Reported Event|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
185346|NCT01431521|E3|Reported Event|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg once daily for 4 weeks.
185347|NCT01431521|E2|Reported Event|Placebo for MK-4074|Participants will receive oral doses of placebo matching MK-4074 twice daily for 4 weeks.
185348|NCT01431521|E1|Reported Event|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
185349|NCT01431508|B1|Baseline|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks.
185350|NCT01431508|P1|Participant Flow|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
185351|NCT01431508|O1|Outcome|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
185352|NCT01431508|E1|Reported Event|Losartan 50 mg/HCTZ 12.5 mg|
185353|NCT01431391|B3|Baseline|Total|Total of all reporting groups
185354|NCT01431391|B2|Baseline|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
185355|NCT01431391|B1|Baseline|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
185356|NCT01431391|P2|Participant Flow|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
185386|NCT01431300|O3|Outcome|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging
gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
185387|NCT01431300|O2|Outcome|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
185357|NCT01431391|P1|Participant Flow|Arm 1:Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started androgen deprivation therapy (ADT) with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
185358|NCT01431391|O2|Outcome|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
185359|NCT01431391|O1|Outcome|Arm 1:Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started androgen deprivation therapy (ADT) with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
185360|NCT01431391|O2|Outcome|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
185361|NCT01431391|O1|Outcome|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
185362|NCT01431391|E2|Reported Event|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
185363|NCT01431391|E1|Reported Event|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
185364|NCT01431339|B3|Baseline|Total|Total of all reporting groups
185365|NCT01431339|B2|Baseline|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
185366|NCT01431339|B1|Baseline|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
185367|NCT01431339|P2|Participant Flow|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
185368|NCT01431339|P1|Participant Flow|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
185369|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
185370|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
185371|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
185372|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
185373|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
185374|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
185375|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
185376|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
185377|NCT01431339|E2|Reported Event|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
185378|NCT01431339|E1|Reported Event|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
185379|NCT01431300|B4|Baseline|Total|Total of all reporting groups
185380|NCT01431300|B3|Baseline|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging
gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
185381|NCT01431300|B2|Baseline|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
185382|NCT01431300|B1|Baseline|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
185383|NCT01431300|P3|Participant Flow|0.03 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition. This is the FDA-approved dose for lower extremity arterial imaging
185384|NCT01431300|P2|Participant Flow|0.02 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
185385|NCT01431300|P1|Participant Flow|0.01 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
185389|NCT01431300|O3|Outcome|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging
gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
185390|NCT01431300|O2|Outcome|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
185391|NCT01431300|O1|Outcome|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
185392|NCT01431300|E3|Reported Event|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging
gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
185393|NCT01431300|E2|Reported Event|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
185394|NCT01431300|E1|Reported Event|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
185395|NCT01431287|B6|Baseline|Total|Total of all reporting groups
185396|NCT01431287|B5|Baseline|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185397|NCT01431287|B4|Baseline|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185398|NCT01431287|B3|Baseline|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185399|NCT01431287|B2|Baseline|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185400|NCT01431287|B1|Baseline|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185401|NCT01431287|P5|Participant Flow|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185402|NCT01431287|P4|Participant Flow|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185403|NCT01431287|P3|Participant Flow|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185404|NCT01431287|P2|Participant Flow|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185405|NCT01431287|P1|Participant Flow|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185406|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185407|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185408|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185409|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185410|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185411|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185412|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185413|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185414|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185415|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185416|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185417|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185418|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185419|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185420|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185421|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185422|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185423|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185424|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185425|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185426|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185427|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185428|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185429|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185430|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185431|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185432|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185433|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185434|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185435|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185436|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185437|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185438|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185439|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185440|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185441|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185442|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185443|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185444|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185445|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185446|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185447|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185448|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185449|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185450|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185451|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185452|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185453|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185454|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185455|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185456|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185457|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185458|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185459|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185460|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185461|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185462|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185463|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185464|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185465|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185466|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185467|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185468|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185469|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185470|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185471|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185472|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185473|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185474|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185475|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185476|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185477|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185478|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185479|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185480|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185481|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185482|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185483|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185484|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185485|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185486|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185487|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185488|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185489|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185490|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185491|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185492|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185493|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185494|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185495|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185496|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185497|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185498|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185499|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185500|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185501|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185502|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185503|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185504|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185505|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185506|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185507|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185508|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185509|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185510|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185511|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185512|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
187504|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
185513|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185514|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185515|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185516|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185517|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185518|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185519|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185520|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185521|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185522|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185523|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185524|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185525|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185526|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185527|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185528|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185529|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185530|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185531|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185532|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185533|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185534|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185535|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185536|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185537|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185538|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185539|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185540|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185541|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185542|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185543|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185544|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185545|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185546|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185547|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185548|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185549|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185550|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185551|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185552|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
185553|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185554|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
185555|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
185556|NCT01431287|E5|Reported Event|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185557|NCT01431287|E4|Reported Event|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185558|NCT01431287|E3|Reported Event|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185559|NCT01431287|E2|Reported Event|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185560|NCT01431287|E1|Reported Event|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185561|NCT01431274|B6|Baseline|Total|Total of all reporting groups
185562|NCT01431274|B5|Baseline|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185563|NCT01431274|B4|Baseline|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185564|NCT01431274|B3|Baseline|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185565|NCT01431274|B2|Baseline|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185566|NCT01431274|B1|Baseline|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185567|NCT01431274|P5|Participant Flow|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185568|NCT01431274|P4|Participant Flow|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185569|NCT01431274|P3|Participant Flow|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185570|NCT01431274|P2|Participant Flow|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185571|NCT01431274|P1|Participant Flow|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185572|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185573|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185574|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185575|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185576|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185577|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185578|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185579|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185580|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185581|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185582|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185583|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185584|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185585|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185586|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185587|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185588|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185589|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185590|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185591|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185592|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185593|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185594|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185595|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185596|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185597|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185598|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185599|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185600|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185601|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185602|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185603|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185604|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185605|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185606|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185607|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185608|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185609|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185610|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185611|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185612|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185613|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185614|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185615|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185616|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185617|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185618|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185619|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185620|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185621|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185622|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185623|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185624|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185625|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185626|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185627|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185628|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185629|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185630|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185631|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185632|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185633|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185634|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185635|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185636|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185637|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185638|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185639|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185640|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185641|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185642|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185643|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185644|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185645|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185646|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185647|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185648|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185649|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185650|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185651|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185652|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185653|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185654|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185655|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185656|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185657|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185658|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185659|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185660|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185661|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185662|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185663|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185664|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185665|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185666|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185667|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185668|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185669|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185670|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185671|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185672|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185673|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185674|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185675|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185676|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185677|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185678|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185679|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185680|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185681|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185682|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185683|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185684|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185685|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185686|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185687|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185688|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185689|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
187505|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
185690|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185691|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185692|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185693|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185694|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185695|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185696|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185697|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185698|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185699|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185700|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185701|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185702|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185703|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185704|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185705|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185706|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185707|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185708|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185709|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185710|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185711|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185712|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185713|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185714|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185715|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185716|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185717|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185718|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185719|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185720|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185721|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185722|NCT01431274|E5|Reported Event|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185905|NCT01430624|B3|Baseline|Standard Care (Completing Baseline)|Standard Care Condition completing baseline
185723|NCT01431274|E4|Reported Event|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185724|NCT01431274|E3|Reported Event|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185725|NCT01431274|E2|Reported Event|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185726|NCT01431274|E1|Reported Event|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
185727|NCT01431170|B3|Baseline|Total|Total of all reporting groups
185728|NCT01431170|B2|Baseline|Polytrim Treatment Group|Subjects received Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
185729|NCT01431170|B1|Baseline|Besivance Treatment Group|Subjects received Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
185730|NCT01431170|P2|Participant Flow|Polytrim Treatment Group|Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily for 10 days.
185731|NCT01431170|P1|Participant Flow|Besivance Treatment Group|Subjects receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily for 10 days.
185732|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of subjects treated with Polytrim ophthalmic solution, who achieved treatment success by the study close-out visit (week 16).
185733|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of subjects treated with Besivance™ ophthalmic suspension, 0.6%, who achieved treatment success by the study close-out visit (week 16).
185734|NCT01431170|O2|Outcome|Polytrim Safety Outcomes|Number of reported medication safety issues in the Polytrim Treatment Group
185735|NCT01431170|O1|Outcome|Besivance Safety Outcomes|Number of reported medication safety issues in the Besivance Treatment Group.
185736|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of Treatment Failures for subjects randomized to the Polytrim treatment group.
185737|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of Treatment Failures for subjects randomized to the Besivance treatment group.
185738|NCT01431170|O2|Outcome|Efficacy of Polytrim Treatment Group|Number of subjects who had a recurrence randomized to the Polytrim treatment group,
185739|NCT01431170|O1|Outcome|Efficacy of Besivance Treatment Group|Number of subjects who had a recurrence randomized to the Besivance treatment group.
185740|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of subjects who had a recurrence randomized to the Polytrim treatment group,
185741|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of subjects who had a recurrence randomized to the Besivance treatment group.
185742|NCT01431170|O2|Outcome|Polytrim Treatment Group|Subjects received Polytrim ophthalmic solution in the study eye, one drop three times daily for ten days.
185743|NCT01431170|O1|Outcome|Besivance Treatment Group|Subjects received Besivance ophthalmic solution in the study eye, one drop three times a day for ten days
185744|NCT01431170|E2|Reported Event|Polytrim Treatment Group|Subjects randomized to the Polytrim treatment group.
185745|NCT01431170|E1|Reported Event|Besivance Treatment Group|Subjects randomized to the Besivance treatment group.
185746|NCT01431144|B3|Baseline|Total|Total of all reporting groups
185747|NCT01431144|B2|Baseline|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
185748|NCT01431144|B1|Baseline|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
185749|NCT01431144|P2|Participant Flow|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
185750|NCT01431144|P1|Participant Flow|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
185751|NCT01431144|O2|Outcome|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
185752|NCT01431144|O1|Outcome|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
185753|NCT01431144|E2|Reported Event|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
185754|NCT01431144|E1|Reported Event|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
185755|NCT01431131|B3|Baseline|Total|Total of all reporting groups
185756|NCT01431131|B2|Baseline|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
185757|NCT01431131|B1|Baseline|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
185758|NCT01431131|P2|Participant Flow|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
185759|NCT01431131|P1|Participant Flow|Intrasocket Graft|Positive control, an intrasocket cancellous allograft is placed
185760|NCT01431131|O2|Outcome|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
185761|NCT01431131|O1|Outcome|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
185762|NCT01431131|O2|Outcome|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
185763|NCT01431131|O1|Outcome|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
185764|NCT01431131|E2|Reported Event|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
185765|NCT01431131|E1|Reported Event|Intrasocket Graft|Positive control, an intrasocket cancellous allograft will be placed
185766|NCT01431079|B3|Baseline|Total|Total of all reporting groups
185767|NCT01431079|B2|Baseline|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185768|NCT01431079|B1|Baseline|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185769|NCT01431079|P2|Participant Flow|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185770|NCT01431079|P1|Participant Flow|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185771|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
185772|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185773|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
185774|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185775|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185776|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185777|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
185778|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185779|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
185780|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185781|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185782|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185783|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
185784|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185785|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
185786|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185787|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185788|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185789|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for an education based on knowledge regarding HPV vaccine acceptability.
185790|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185791|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for an education based on knowledge regarding HPV vaccine acceptability.
185792|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide posttest data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185906|NCT01430624|B2|Baseline|PIRI (Completing Baseline)|Pleasant Imagery and Relaxation Instruction
185793|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for an education based on knowledge regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185794|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185795|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
185796|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185797|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
185798|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185799|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185800|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide base line data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185801|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This control group will provide follow-up data for knowledge based education for HPV vaccine
185802|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental group will provide follow-up data for an Health belief model based educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185803|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This control group will provide post test data for knowledge based education for HPV vaccine
185804|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental group will provide post test data for an HBM based educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185805|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185806|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185807|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data regarding education based on knowledge regarding HPV vaccine acceptability.
185808|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185809|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This comparison arm will provide post test data regarding education based on knowledge regarding HPV vaccine acceptability.
185810|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185811|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data regarding education based on knowledge regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185812|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185813|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability.
185814|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for number of people who have taken HPV vaccine upto 3 months after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185815|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability.
185816|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for number of people who have taken HPV vaccine after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
185817|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for number of people who have taken the HPV vaccine before an education based on knowledge regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185907|NCT01430624|B1|Baseline|PPRS (Completing Baseline)|Prevention of Post-Sexual Assault Stress
185818|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for number of people who have taken HPV vaccine before an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185819|NCT01431079|E2|Reported Event|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185820|NCT01431079|E1|Reported Event|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
185821|NCT01431014|B3|Baseline|Total|Total of all reporting groups
185822|NCT01431014|B2|Baseline|"DexamethasoneLow-dose"|"5mg
Dexamethasonelow-dose : 5mg"
185823|NCT01431014|B1|Baseline|"DexamethasoneHigh-dose"|"15mg
Dexamethasonehigh-dose : 15 mg"
185824|NCT01431014|P2|Participant Flow|"DexamethasoneLow-dose"|"5mg
Dexamethasonelow-dose : 5mg"
185825|NCT01431014|P1|Participant Flow|"DexamethasoneHigh-dose"|"15mg
Dexamethasonehigh-dose : 15 mg"
185826|NCT01431014|O2|Outcome|"DexamethasoneLow-dose"|"5mg Dexamethasonelow-dose : 5 mg"
185827|NCT01431014|O1|Outcome|"DexamethasoneHigh-dose"|"15mg Dexamethasonehigh-dose : 15 mg"
185828|NCT01431014|E2|Reported Event|"DexamethasoneHigh-dose"|"15mg
Dexamethasonehigh-dose: 15 mg"
185829|NCT01431014|E1|Reported Event|"DexamethasoneLow-dose"|"5mg
Dexamethasonelow-dose: 5mg"
185830|NCT01430819|B3|Baseline|Total|Total of all reporting groups
185831|NCT01430819|B2|Baseline|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
185832|NCT01430819|B1|Baseline|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
185833|NCT01430819|P2|Participant Flow|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.
185834|NCT01430819|P1|Participant Flow|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
185835|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
185836|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
185837|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
185838|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
185839|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
185840|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
185841|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
185842|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
185843|NCT01430819|E2|Reported Event|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
185844|NCT01430819|E1|Reported Event|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
185845|NCT01430754|B4|Baseline|Total|Total of all reporting groups
185846|NCT01430754|B3|Baseline|Placebo (Randomized)|"Placebo capsules
Placebo: Placebo capsules, daily"
185847|NCT01430754|B2|Baseline|Tasimelteon (Randomized)|"20 mg tasimelteon capsules
tasimelteon: 20 mg tasimelteon capsules, daily"
185848|NCT01430754|B1|Baseline|Run-In - Not Randomized|"20 mg tasimelteon capsules
tasimelteon: 20 mg capsules, daily"
185849|NCT01430754|P2|Participant Flow|Placebo|"Placebo capsules
Placebo: Placebo capsules, daily"
185850|NCT01430754|P1|Participant Flow|Tasimelteon|"20 mg tasimelteon capsules
tasimelteon: 20 mg tasimelteon capsules, daily"
185851|NCT01430754|O2|Outcome|Placebo|"Placebo capsules
Placebo: Placebo capsules, daily"
185852|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules
tasimelteon: 20 mg tasimelteon capsules, daily"
185853|NCT01430754|O2|Outcome|Placebo|"Placebo capsules
Placebo: Placebo capsules, daily"
185854|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules
tasimelteon: 20 mg tasimelteon capsules, daily"
185855|NCT01430754|O2|Outcome|Placebo|"Placebo capsules
Placebo: Placebo capsules, daily"
185856|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules
tasimelteon: 20 mg tasimelteon capsules, daily"
185857|NCT01430754|O2|Outcome|Placebo|"Placebo capsules
Placebo: Placebo capsules, daily"
185858|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules
tasimelteon: 20 mg tasimelteon capsules, daily"
185859|NCT01430754|O2|Outcome|Placebo|"Placebo capsules
Placebo: Placebo capsules, daily"
185860|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules
tasimelteon: 20 mg tasimelteon capsules, daily"
185861|NCT01430754|O2|Outcome|Placebo|"Placebo capsules
Placebo: Placebo capsules, daily"
185862|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules
tasimelteon: 20 mg tasimelteon capsules, daily"
185863|NCT01430754|E4|Reported Event|Placebo|"Placebo capsules
Placebo: Placebo capsules, daily"
185864|NCT01430754|E3|Reported Event|Tasimelteon|"20 mg tasimelteon capsules
tasimelteon: 20 mg tasimelteon capsules, daily"
185865|NCT01430754|E2|Reported Event|Run-In - Not Randomized|"20 mg tasimelteon capsules
tasimelteon: 20 mg capsules, daily"
185866|NCT01430754|E1|Reported Event|Total Run-In|"20 mg tasimelteon capsules
tasimelteon: 20 mg tasimelteon capsules, daily"
185867|NCT01430741|B5|Baseline|Total|Total of all reporting groups
185908|NCT01430624|P3|Participant Flow|Standard Care|Treatment as usual
185868|NCT01430741|B4|Baseline|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans
185869|NCT01430741|B3|Baseline|Enhanced Implementation Approach GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
185870|NCT01430741|B2|Baseline|MISSION-Vet - IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans."
185871|NCT01430741|B1|Baseline|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
185872|NCT01430741|P4|Participant Flow|GTO MISSION Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
185873|NCT01430741|P3|Participant Flow|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
185874|NCT01430741|P2|Participant Flow|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
185875|NCT01430741|P1|Participant Flow|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
185876|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
185877|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
185878|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
185879|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
185880|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
185881|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
185882|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
185883|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
185884|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
185885|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
185909|NCT01430624|P2|Participant Flow|PIRI Video|"Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
186154|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
185886|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
185887|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
185888|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
185889|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
185890|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
185891|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
185892|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
185893|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
185894|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
185895|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
185896|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
185897|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
185898|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
185899|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
185900|NCT01430741|E4|Reported Event|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans
185901|NCT01430741|E3|Reported Event|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
185902|NCT01430741|E2|Reported Event|MISSION-Vet - IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
185903|NCT01430741|E1|Reported Event|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.
Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
185904|NCT01430624|B4|Baseline|Total|Total of all reporting groups
185910|NCT01430624|P1|Participant Flow|PPRS Video|"Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
185911|NCT01430624|O3|Outcome|Standard Care|Treatment as usual which included standard care
185912|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
185913|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
185914|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
185915|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
185916|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
185917|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
185918|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
185919|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
185920|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
185921|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
185922|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
185923|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
185924|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
185925|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
185926|NCT01430624|O3|Outcome|SC Condition|Standard Care Completing Follow-up
185927|NCT01430624|O2|Outcome|PIRI|Pleasant Imagery and Relaxation Condition
185928|NCT01430624|O1|Outcome|PPRS|Prevention of Post-Sexual Assault Stress
185929|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
185930|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
185931|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
185932|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
185933|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
185934|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
185935|NCT01430624|E3|Reported Event|Standard Care Condition|Standard Care Condition
185936|NCT01430624|E2|Reported Event|PIRI|Pleasant Imagery and Relaxation Instruction
185937|NCT01430624|E1|Reported Event|PPRS|Prevention of Post-Sexual Assault Stress
185938|NCT01430611|B3|Baseline|Total|Total of all reporting groups
185939|NCT01430611|B2|Baseline|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
185940|NCT01430611|B1|Baseline|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
185941|NCT01430611|P2|Participant Flow|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
185942|NCT01430611|P1|Participant Flow|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
185943|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
185944|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
185945|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
185946|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
185947|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
185948|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
185949|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
185950|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
186155|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients
Placebo: Placebo comparator"
185951|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
185952|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
185953|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
185954|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
185955|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
185956|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
185957|NCT01430611|E2|Reported Event|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
185958|NCT01430611|E1|Reported Event|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
185959|NCT01430585|B1|Baseline|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
185960|NCT01430585|P1|Participant Flow|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
185961|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185962|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185963|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185964|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185965|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185966|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185967|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185968|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185969|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185970|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
185971|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185972|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185973|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185974|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
185975|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
185976|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185977|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
186002|NCT01430403|B3|Baseline|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
185978|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185979|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
185980|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185981|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185982|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185983|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
185984|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185985|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185986|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185987|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185988|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185989|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
185990|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
185991|NCT01430585|E1|Reported Event|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
185992|NCT01430468|B3|Baseline|Total|Total of all reporting groups
185993|NCT01430468|B2|Baseline|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
185994|NCT01430468|B1|Baseline|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.
Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
185995|NCT01430468|P2|Participant Flow|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
185996|NCT01430468|P1|Participant Flow|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.
Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
185997|NCT01430468|O2|Outcome|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
185998|NCT01430468|O1|Outcome|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.
Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
185999|NCT01430468|E2|Reported Event|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
186000|NCT01430468|E1|Reported Event|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.
Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
186001|NCT01430403|B4|Baseline|Total|Total of all reporting groups
186147|NCT01429623|P2|Participant Flow|Placebo Control|"drug product excipients
Placebo: Placebo comparator"
186003|NCT01430403|B2|Baseline|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
186004|NCT01430403|B1|Baseline|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
186005|NCT01430403|P3|Participant Flow|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
186006|NCT01430403|P2|Participant Flow|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
186007|NCT01430403|P1|Participant Flow|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
186008|NCT01430403|O2|Outcome|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
186009|NCT01430403|O1|Outcome|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
186010|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186011|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186012|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186013|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186014|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186015|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186016|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186017|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186018|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186019|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186020|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186784|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186021|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186022|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186023|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186024|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186025|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186026|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186027|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186028|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186029|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186030|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186031|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186032|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186033|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186034|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186035|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186036|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186148|NCT01429623|P1|Participant Flow|Ladostigil Hemitartrate|"10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
186149|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients
Placebo: Placebo comparator"
186037|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186038|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186039|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186040|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186041|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186042|NCT01430403|O2|Outcome|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
186043|NCT01430403|O1|Outcome|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
186044|NCT01430403|O2|Outcome|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
186045|NCT01430403|O1|Outcome|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
186046|NCT01430403|O2|Outcome|Samples Without Exacerbations|These nasal mucus samples were not associated with an exacerbation (defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at >/= 20mg per day for 3 of any 5 consecutive days; or dexamethasone at >/= 10mg per day for >/= 1 day)
186047|NCT01430403|O1|Outcome|Samples With Exacerbations|These nasal mucus samples were associated with an exacerbation (defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at >/= 20mg per day for 3 of any 5 consecutive days; or dexamethasone at >/= 10mg per day for >/= 1 day)
186048|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186049|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186050|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186051|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
186052|NCT01430403|E3|Reported Event|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
186053|NCT01430403|E2|Reported Event|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
186150|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
186054|NCT01430403|E1|Reported Event|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
186055|NCT01430325|B5|Baseline|Total|Total of all reporting groups
186056|NCT01430325|B4|Baseline|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186057|NCT01430325|B3|Baseline|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186058|NCT01430325|B2|Baseline|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186059|NCT01430325|B1|Baseline|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186060|NCT01430325|P4|Participant Flow|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186061|NCT01430325|P3|Participant Flow|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186062|NCT01430325|P2|Participant Flow|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186063|NCT01430325|P1|Participant Flow|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186064|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186065|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186066|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186067|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186068|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186069|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186070|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186071|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186072|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186073|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186074|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186075|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186076|NCT01430325|E4|Reported Event|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186077|NCT01430325|E3|Reported Event|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186078|NCT01430325|E2|Reported Event|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
186079|NCT01430325|E1|Reported Event|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
186080|NCT01430182|B3|Baseline|Total|Total of all reporting groups
186151|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients
Placebo: Placebo comparator"
186081|NCT01430182|B2|Baseline|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
186082|NCT01430182|B1|Baseline|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
186083|NCT01430182|P2|Participant Flow|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
186084|NCT01430182|P1|Participant Flow|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
186085|NCT01430182|O2|Outcome|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
186086|NCT01430182|O1|Outcome|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
186087|NCT01430182|E2|Reported Event|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
186088|NCT01430182|E1|Reported Event|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.
Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
186089|NCT01430169|B1|Baseline|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186090|NCT01430169|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg (First Injection is administered on Day 1 and the second Injection is administered on Day 2)"
186091|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186092|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186093|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186094|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186095|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186096|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186097|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186098|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186099|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186100|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186101|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186102|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186103|NCT01430169|E1|Reported Event|AA4500|"collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg"
186104|NCT01430130|B1|Baseline|All Study Participants|Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
186105|NCT01430130|P1|Participant Flow|All Study Participants|Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
186106|NCT01430130|O2|Outcome|Control Side|Half of the revised incision was treated according to the investigator’s standard of care. Participant served as his own control.
186107|NCT01430130|O1|Outcome|Treated Side|Half of the revised incision was treated with the embrace device.
186108|NCT01430130|E2|Reported Event|Control Side|Half of the revised incision was treated according to the investigator’s standard of care. Participant served as his own control.
186109|NCT01430130|E1|Reported Event|Treated Side|Half of the revised incision was treated with the embrace device.
186110|NCT01430104|B1|Baseline|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186111|NCT01430104|P1|Participant Flow|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186112|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186152|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
186113|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186114|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186115|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186116|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186117|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide planned dose during 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186118|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186119|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186120|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186121|NCT01430104|E1|Reported Event|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
186122|NCT01430091|B1|Baseline|Participants|Total Number of Study Participants
186123|NCT01430091|P1|Participant Flow|Participants|Received 5 milligrams (mg) prasugrel as either the clinical tablet or as an orally disintegrating tablet (ODT).
186124|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
186125|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
186126|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
186127|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating table (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
186128|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole approximately 180 milliliters (ml) with water.
186129|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
186130|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
186131|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
186132|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
186133|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
186134|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
186135|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
186136|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
186137|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
186138|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
186139|NCT01430091|E5|Reported Event|ODT (Under Tongue)|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
186140|NCT01430091|E4|Reported Event|ODT (Chew and Swallow)|5-mg prasugrel ODT chewed and swallowed, no liquid given.
186141|NCT01430091|E3|Reported Event|ODT (Juice Chaser)|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
186142|NCT01430091|E2|Reported Event|ODT (Top of Tongue)|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
186143|NCT01430091|E1|Reported Event|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
186144|NCT01429623|B3|Baseline|Total|Total of all reporting groups
186145|NCT01429623|B2|Baseline|Placebo Control|"drug product excipients
Placebo: Placebo comparator"
186146|NCT01429623|B1|Baseline|Ladostigil Hemitartrate|"10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
186156|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
186157|NCT01429623|E2|Reported Event|Placebo Control|"drug product excipients
Placebo: Placebo comparator"
186158|NCT01429623|E1|Reported Event|Ladostigil Hemitartrate|"10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
186159|NCT01429584|B3|Baseline|Total|Total of all reporting groups
186160|NCT01429584|B2|Baseline|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
186161|NCT01429584|B1|Baseline|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
186162|NCT01429584|P2|Participant Flow|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
186163|NCT01429584|P1|Participant Flow|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
186164|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
186165|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
186166|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
186167|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
186168|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
186169|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
186170|NCT01429584|E2|Reported Event|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
186171|NCT01429584|E1|Reported Event|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
186172|NCT01429532|B4|Baseline|Total|Total of all reporting groups
186173|NCT01429532|B3|Baseline|Group III|3.0-mm-incision-size phacoemulsification system
186174|NCT01429532|B2|Baseline|Group II|2.2-mm-incision-size phacoemulsification system
186175|NCT01429532|B1|Baseline|Group I|1.8-mm-incision-size phacoemulsification system
186176|NCT01429532|P3|Participant Flow|Group III|3.0-mm-incision-size phacoemulsification system
186177|NCT01429532|P2|Participant Flow|Group II|2.2-mm-incision-size phacoemulsification system
186178|NCT01429532|P1|Participant Flow|Group I|1.8-mm-incision-size phacoemulsification system
186179|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
186180|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
186181|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
186182|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
186183|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
186184|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
186185|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
186186|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
186187|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
186188|NCT01429532|E3|Reported Event|Group III|3.0-mm-incision-size phacoemulsification system
186189|NCT01429532|E2|Reported Event|Group II|2.2-mm-incision-size phacoemulsification system
186190|NCT01429532|E1|Reported Event|Group I|1.8-mm-incision-size phacoemulsification system
186191|NCT01429441|B3|Baseline|Total|Total of all reporting groups
186192|NCT01429441|B2|Baseline|Sham|Subjects in the sham group received a single sham injection
186193|NCT01429441|B1|Baseline|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
186194|NCT01429441|P2|Participant Flow|Sham|Subjects in the sham group received a single sham injection
186195|NCT01429441|P1|Participant Flow|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
186196|NCT01429441|O2|Outcome|Sham|Subjects in the sham group received a single sham injection
186197|NCT01429441|O1|Outcome|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
186198|NCT01429441|O2|Outcome|Sham|Subjects in the sham group received a single sham injection
186199|NCT01429441|O1|Outcome|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
186200|NCT01429441|E2|Reported Event|Sham|Subjects in the sham group received a single sham injection
186201|NCT01429441|E1|Reported Event|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
186202|NCT01429259|B1|Baseline|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.
meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
186203|NCT01429259|P1|Participant Flow|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.
meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
186204|NCT01429259|O1|Outcome|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.
meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
186205|NCT01429259|O1|Outcome|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.
meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
186206|NCT01429259|E1|Reported Event|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.
meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
186207|NCT01429077|B3|Baseline|Total|Total of all reporting groups
186208|NCT01429077|B2|Baseline|Inactive Pill|
186209|NCT01429077|B1|Baseline|Levodopa|
186210|NCT01429077|P2|Participant Flow|Inactive Pill|The inactive pill was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
186247|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
186211|NCT01429077|P1|Participant Flow|Levodopa|The study drug (100 mg levodopa / 25 mg carbidopa), was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
186212|NCT01429077|O2|Outcome|Inactive Pill|
186213|NCT01429077|O1|Outcome|Levodopa/Carbidopa|
186214|NCT01429077|E2|Reported Event|Inactive Pill|
186215|NCT01429077|E1|Reported Event|Levodopa|
186216|NCT01429064|B5|Baseline|Total|Total of all reporting groups
186217|NCT01429064|B4|Baseline|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186218|NCT01429064|B3|Baseline|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186219|NCT01429064|B2|Baseline|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186220|NCT01429064|B1|Baseline|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
186221|NCT01429064|P4|Participant Flow|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186222|NCT01429064|P3|Participant Flow|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186223|NCT01429064|P2|Participant Flow|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186224|NCT01429064|P1|Participant Flow|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
186225|NCT01429064|O4|Outcome|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186226|NCT01429064|O3|Outcome|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186227|NCT01429064|O2|Outcome|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186228|NCT01429064|O1|Outcome|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
186229|NCT01429064|E4|Reported Event|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186230|NCT01429064|E3|Reported Event|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186231|NCT01429064|E2|Reported Event|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
186232|NCT01429064|E1|Reported Event|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
186233|NCT01429051|B1|Baseline|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
186234|NCT01429051|P1|Participant Flow|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
186235|NCT01429051|O3|Outcome|Tolerability Phase|Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
186236|NCT01429051|O2|Outcome|Efficacy Phase|Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence.
186237|NCT01429051|O1|Outcome|Titration Phase|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase.
186238|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
186239|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
186240|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
186241|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
186242|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
186243|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
186244|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
186245|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
186246|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
186248|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
186249|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
186250|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
186251|NCT01429051|E3|Reported Event|Tolerability Phase|Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
186252|NCT01429051|E2|Reported Event|Efficacy Phase|Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence.
186253|NCT01429051|E1|Reported Event|Titration Phase|Participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I).
186254|NCT01428882|B3|Baseline|Total|Total of all reporting groups
186255|NCT01428882|B2|Baseline|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion
Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186256|NCT01428882|B1|Baseline|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion
Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186257|NCT01428882|P2|Participant Flow|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion
Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186258|NCT01428882|P1|Participant Flow|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion
Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186259|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion
Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186260|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion
Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186261|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion
Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186262|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion
Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186263|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion
Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186264|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion
Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186265|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion
Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186266|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion
Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186267|NCT01428882|E2|Reported Event|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion
Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186268|NCT01428882|E1|Reported Event|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion
Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
186269|NCT01428765|B1|Baseline|All Patients|
186270|NCT01428765|P1|Participant Flow|All Patients|
186271|NCT01428765|O1|Outcome|All Patients|
186272|NCT01428765|O1|Outcome|All Patients|
186273|NCT01428765|O1|Outcome|All Patients|
186274|NCT01428765|O1|Outcome|All Patients|
186275|NCT01428765|O1|Outcome|All Patients|
186276|NCT01428765|O1|Outcome|All Patients|
186277|NCT01428765|O1|Outcome|All Patients|
186278|NCT01428765|O1|Outcome|All Patients|
186279|NCT01428765|E1|Reported Event|All Patients|
186355|NCT01428258|E1|Reported Event|GMP Diet/GMP Medical Foods|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
186280|NCT01428713|B1|Baseline|All Study Participants|"Group A: TA first, then COCP:
Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.
Subsequently, patients who initially received TA, received COCP.
Group B: COCP first, then TA:
Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP.
Subsequently, patients who initially received COCP, received TA."
186281|NCT01428713|P2|Participant Flow|Group B: COCP First, Then TA|"Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between COCP and TA.
Subsequently, patients who initially received COCP, received TA. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles."
186282|NCT01428713|P1|Participant Flow|Group A: TA First, Then COCP|"Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.
Subsequently, patients who initially received TA, received COCP. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP."
186283|NCT01428713|O2|Outcome|Group: COCP|Patients received COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles.
186284|NCT01428713|O1|Outcome|Group: TA|Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.
186285|NCT01428713|E2|Reported Event|Combined Oral Contraceptives (COCP)|COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between medications.
186286|NCT01428713|E1|Reported Event|Tranexamic Acid (TA)|"Patients received oral tranexamic acid at 1300 mg three times each day on days 1 to 5 of menstrual cycle for 3 cycles. The mean age of the study population was 14.2 years. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.
Subsequently, patients who initially received TA, received COCP and patients who initially received COCP, then received TA."
186287|NCT01428661|B4|Baseline|Total|Total of all reporting groups
186288|NCT01428661|B3|Baseline|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
186289|NCT01428661|B2|Baseline|Placebo|Placebo capsules, PO daily for 8 weeks
186290|NCT01428661|B1|Baseline|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
186291|NCT01428661|P3|Participant Flow|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
186292|NCT01428661|P2|Participant Flow|Placebo|Placebo capsules, PO daily for 8 weeks
186293|NCT01428661|P1|Participant Flow|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
186294|NCT01428661|O3|Outcome|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
186295|NCT01428661|O2|Outcome|Placebo|Placebo capsules, PO daily for 8 weeks
186296|NCT01428661|O1|Outcome|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
186297|NCT01428661|E3|Reported Event|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
186298|NCT01428661|E2|Reported Event|Placebo|Placebo capsules, PO daily for 8 weeks
186299|NCT01428661|E1|Reported Event|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
186300|NCT01428583|B1|Baseline|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186301|NCT01428583|P1|Participant Flow|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186302|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186393|NCT01428063|P2|Participant Flow|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
186303|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186304|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186305|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186306|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186307|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186308|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186309|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186310|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186311|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186312|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186313|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186314|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186392|NCT01428063|P3|Participant Flow|Daclatasvir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186315|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186316|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186317|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186318|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186319|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186320|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186321|NCT01428583|E1|Reported Event|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
186322|NCT01428336|B3|Baseline|Total|Total of all reporting groups
186323|NCT01428336|B2|Baseline|Volunteers|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
186324|NCT01428336|B1|Baseline|Patients|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
186325|NCT01428336|P2|Participant Flow|Volunteers|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
186326|NCT01428336|P1|Participant Flow|Patients|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
186327|NCT01428336|O2|Outcome|Volunteers|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
186328|NCT01428336|O1|Outcome|Patients|Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
186329|NCT01428336|O1|Outcome|Patients + Volunteers|Every participant underwent three ACTH stimulation test and one Insulin tolerance test.
186330|NCT01428336|O1|Outcome|Patients + Volunteers|Every participant underwent three ACTH stimulation test and one Insulin tolerance test.
186331|NCT01428336|E4|Reported Event|Insulin Tolerance Test|"Subjects will undergo an Insulin Tolerance Test
Insulin tolerance test: subjects will undergo an insulin tolerance test"
186332|NCT01428336|E3|Reported Event|25 ug Cortrosyn Stimulation Test|"Subjects will undergo an ACTH stimulation test using a 25 ug cortosyn dose
25 ug Cortrosyn stimulation test: ACTH stimulation test using a 25 ug cortrosyn dose"
186333|NCT01428336|E2|Reported Event|250 ug Cortrosyn Dose Stimulation Test|"Subjects will undergo an ACTH stimulation test using 250 ug cortrosyn dose
250 ug ACTH stimulation test: ACTH stimulation test will be done using 250 ug cortrosyn dose"
186334|NCT01428336|E1|Reported Event|1ug Cortrosyn Dose Stimulation Test|"Subjects will undergo an ACTH stimulation test using a dose of 1 ug cotrosyn
ACTH stimulation test: 1 ug cortrosyn dose
1 ug cortrosyn test: Subjects will undergo an ACTH test using a 1 ug dose cortrosyn"
186335|NCT01428258|B3|Baseline|Total|Total of all reporting groups
186356|NCT01428219|B1|Baseline|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
186336|NCT01428258|B2|Baseline|AA Diet - GMP Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the AA diet followed by the GMP diet referred to as the Amino Acid (AA) Diet given first intervention.
Amino Acid (AA) Diet Given First: The intervention compares the usual amino acid (AA) low-phenylalanine (phe) dietary therapy with a new dietary therapy for PKU, a low-phe diet containing foods and beverages made from glycomacropeptide (GMP). PKU subjects in the AA Diet-GMP Diet Arm will follow their usual AA diet for 3 weeks followed by a 3 wk wash out period. They will then replace all of the protein equivalents provided in their diet by AA formula with foods and beverages made from GMP using Glytactin as provided by Cambrooke Foods, LLC. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
186337|NCT01428258|B1|Baseline|GMP Diet-AA Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the the GMP diet followed by the AA diet referred to as the Glycomacropeptide (GMP) diet given first intervention.
Glycomacropeptide (GMP) diet given first: The intervention compares a new low-phenylalanine (phe) dietary therapy for PKU, a diet containing foods and beverages made from GMP using Glytactin provided by Cambrooke Foods LLC, with the usual amino acid (AA) low-phe dietary therapy. PKU subjects in the GMP Diet-AA Diet Arm will follow the GMP diet that will replace all of the dietary protein equivalents provided by AA formula with foods and beverages made from GMP for 3 weeks followed by a 3 wk wash out period. They will then follow the usual AA diet for 3 weeks. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
186338|NCT01428258|P2|Participant Flow|AA Diet - GMP Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the AA diet followed by the GMP diet referred to as the Amino Acid (AA) Diet given first intervention.
Amino Acid (AA) Diet Given First: The intervention compares the usual amino acid (AA) low-phenylalanine (phe) dietary therapy with a new dietary therapy for PKU, a low-phe diet containing foods and beverages made from glycomacropeptide (GMP). PKU subjects in the AA Diet-GMP Diet Arm will follow their usual AA diet for 3 weeks followed by a 3 wk wash out period. They will then replace all of the protein equivalents provided in their diet by AA formula with foods and beverages made from GMP using Glytactin as provided by Cambrooke Foods, LLC. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
186339|NCT01428258|P1|Participant Flow|GMP Diet-AA Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the the GMP diet followed by the AA diet referred to as the Glycomacropeptide (GMP) diet given first intervention.
Glycomacropeptide (GMP) diet given first: The intervention compares a new low-phenylalanine (phe) dietary therapy for PKU, a diet containing foods and beverages made from GMP using Glytactin provided by Cambrooke Foods LLC, with the usual amino acid (AA) low-phe dietary therapy. PKU subjects in the GMP Diet-AA Diet Arm will follow the GMP diet that will replace all of the dietary protein equivalents provided by AA formula with foods and beverages made from GMP for 3 weeks followed by a 3 wk wash out period. They will then follow the usual AA diet for 3 weeks. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
186340|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|The intervention administered as the first or second dietary treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.
186341|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|The intervention administered as the first or second dietary treatment consists of a low-Phe diet in combination with medical foods made with glycomacropeptide.
186342|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.
186343|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with medical foods made with glycomacropeptide.
186344|NCT01428258|O2|Outcome|Phe Concentration in Dried Blood Spots, Tandem Mass Spec|Subjects spotted their blood on filter paper at the same time as plasma was obtained at 3 or 4 time periods, dried blood spots were obtained, and analyzed for Phe concentration using tandem mass spectrometry.
186345|NCT01428258|O1|Outcome|Phe Concentration in Plasma, Ion Exchange Chromatography|Blood was collected by venipuncture at 3 to 4 time points, plasma was isolated and the concentration of Phe was determined by ion exchange chromatography.
186346|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
186347|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
186348|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.
186349|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with medical foods made from glycomacropeptide .
186350|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
186351|NCT01428258|O1|Outcome|GMP Diet|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
186352|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
186353|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
186354|NCT01428258|E2|Reported Event|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
186868|NCT01426230|B2|Baseline|Open Label - Cohort <=70 Yrs Old|"Cohort by age-
- Patients <=70 Yrs old"
186357|NCT01428219|P1|Participant Flow|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
186358|NCT01428219|O1|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
186359|NCT01428219|E1|Reported Event|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
186360|NCT01428128|B1|Baseline|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
186361|NCT01428128|P1|Participant Flow|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
186362|NCT01428128|O1|Outcome|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
186363|NCT01428128|E1|Reported Event|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
186364|NCT01428115|B1|Baseline|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186365|NCT01428115|P1|Participant Flow|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186366|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186367|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186368|NCT01428115|O1|Outcome|Adalimumab|40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186369|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186370|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186371|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186372|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186373|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186374|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186375|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186376|NCT01428115|E1|Reported Event|Adalimumab|40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
186377|NCT01428076|B3|Baseline|Total|Total of all reporting groups
186378|NCT01428076|B2|Baseline|Polidocanol 2%|polidocanol intravenous foam 2% concentration
186379|NCT01428076|B1|Baseline|Polidocanol 1%|polidocanol injectable foam 1% concentration
186380|NCT01428076|P2|Participant Flow|Polidocanol 2%|polidocanol injectable foam 2% concentration
186381|NCT01428076|P1|Participant Flow|Polidocanol 1%|polidocanol injectable foam 1% concentration
186382|NCT01428076|O4|Outcome|Females- Polidocanol 2%|polidocanol injectable foam 2% concentration
186383|NCT01428076|O3|Outcome|Females-polidocanol 1%|polidocanol injectable foam 1% concentration
186384|NCT01428076|O2|Outcome|Males-polidocanol 2%|polidocanol injectable foam 2% concentration
186385|NCT01428076|O1|Outcome|Males-polidocanol 1%|polidocanol injectable foam 1% concentration
186386|NCT01428076|E2|Reported Event|Polidocanol 2%|polidocanol injectable foam 2% concentration
186387|NCT01428076|E1|Reported Event|Polidocanol 1%|polidocanol injectable foam 1% concentration
186388|NCT01428063|B4|Baseline|Total|Total of all reporting groups
186389|NCT01428063|B3|Baseline|Daclatasvir + pegIFN-2a+ Ribavirin|Patients received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
186390|NCT01428063|B2|Baseline|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
186391|NCT01428063|B1|Baseline|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
186394|NCT01428063|P1|Participant Flow|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
186869|NCT01426230|B1|Baseline|Open Label - Cohort >70 Yrs Old|"Cohort by age-
- Patients >70 Yrs old"
186395|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186396|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
186397|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
186398|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186399|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186400|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186401|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186402|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186403|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
186404|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186405|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
186406|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
186407|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186408|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186409|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186410|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186411|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186412|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
186413|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186414|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
186711|NCT01426789|P5|Participant Flow|Group 3|Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
186415|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
186416|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186417|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186418|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186419|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186420|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186421|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
186422|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186423|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
186424|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
186425|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186426|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186427|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186428|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186429|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186430|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
186431|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186432|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
186433|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
186434|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186435|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186436|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186437|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186438|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186439|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
186440|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186441|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
186442|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
186443|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186444|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186445|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186446|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186447|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186448|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
186449|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186450|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
186451|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
186452|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186453|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186542|NCT01427751|B2|Baseline|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
186454|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186455|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186456|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4)|Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186457|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
186458|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR)|Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
186459|NCT01428063|E3|Reported Event|Daclatasvir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
186460|NCT01428063|E2|Reported Event|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
186461|NCT01428063|E1|Reported Event|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks.
186462|NCT01427933|B3|Baseline|Total|Total of all reporting groups
186463|NCT01427933|B2|Baseline|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
186464|NCT01427933|B1|Baseline|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
186465|NCT01427933|P2|Participant Flow|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
186466|NCT01427933|P1|Participant Flow|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
186467|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
186468|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
186469|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
186470|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
186471|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
186472|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
186473|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
186474|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
186475|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
186476|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
186477|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
186478|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
186479|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
186480|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
186481|NCT01427933|E2|Reported Event|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
186482|NCT01427933|E1|Reported Event|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
186483|NCT01427920|B3|Baseline|Total|Total of all reporting groups
186543|NCT01427751|B1|Baseline|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
186544|NCT01427751|P2|Participant Flow|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
186484|NCT01427920|B2|Baseline|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186485|NCT01427920|B1|Baseline|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186486|NCT01427920|P2|Participant Flow|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186487|NCT01427920|P1|Participant Flow|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186488|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186489|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186490|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186491|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186492|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186545|NCT01427751|P1|Participant Flow|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
186712|NCT01426789|P4|Participant Flow|Group 2|Part 1: secukinumab 6 x 10 mg/kg i.v.; part 2: no study treatment
186493|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186494|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186495|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186496|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186497|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186498|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186499|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186500|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186501|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186546|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
186713|NCT01426789|P3|Participant Flow|Group 1|Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
186502|NCT01427920|E2|Reported Event|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186503|NCT01427920|E1|Reported Event|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
186504|NCT01427907|B3|Baseline|Total|Total of all reporting groups
186505|NCT01427907|B2|Baseline|Sequence II: Sevelamer Then COS|Sevelamer Carbonate for 4 weeks then Calcium Acetate Oral Solution for 4 weeks
186506|NCT01427907|B1|Baseline|Sequence I: COS Then Sevelamer|Sequence I: Calcium Acetate Oral Solution for 4 weeks then Sevelamer Carbonate for 4 weeks
186507|NCT01427907|P2|Participant Flow|Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks)|Patient receive Sevelamer tablets for 4 weeks, then cross over to take COS for 4 weeks.
186508|NCT01427907|P1|Participant Flow|Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks)|Patient receive Calcium Acetate Oral Solution (COS) for 4 weeks then cross over to Sevelamer tablets for 4 weeks.
186509|NCT01427907|O2|Outcome|Sevelamer Carbonate|Sevelamer Carbonate for periods 1 and 2
186510|NCT01427907|O1|Outcome|Calcium Acetate Oral Solution|Calcium Acetate Oral Solution for periods 1 and 2
186511|NCT01427907|E2|Reported Event|Sevelamer Carbonate|Sevelamer Carbonate for periods 1 and 2
186512|NCT01427907|E1|Reported Event|Calcium Acetate Oral Solution|Sequence I: Calcium Acetate Oral Solution for periods 1 and 2
186513|NCT01427881|B1|Baseline|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186514|NCT01427881|P1|Participant Flow|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186515|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186516|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186547|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
186548|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
186549|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
186714|NCT01426789|P2|Participant Flow|Placebo|Placebo i.v.
186517|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186518|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186519|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186520|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186521|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186522|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186523|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186550|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
186551|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
186552|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
186715|NCT01426789|P1|Participant Flow|Secukinumab|10 mg/kg intravenous (I.V.)
186524|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186525|NCT01427881|E1|Reported Event|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
cyclophosphamide: Given IV
cyclosporine: Given IV
peripheral blood stem cell transplantation: Undergo allogeneic PBSCT
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
busulfan: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
186526|NCT01427803|B3|Baseline|Total|Total of all reporting groups
186527|NCT01427803|B2|Baseline|Reasons for Misuse Interviewed Population|A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
186528|NCT01427803|B1|Baseline|Patterns of Use User Population|A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
186529|NCT01427803|P2|Participant Flow|Reasons for Misuse Cohort|A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
186530|NCT01427803|P1|Participant Flow|Patterns of Use Cohort|A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
186531|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
186532|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
186533|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
186534|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
186535|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
186536|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
186537|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
186538|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
186539|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
186540|NCT01427803|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
186541|NCT01427751|B3|Baseline|Total|Total of all reporting groups
186708|NCT01426789|B2|Baseline|Placebo|Placebo i.v.
186553|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
186554|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
186555|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
186556|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
186557|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
186558|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
186559|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
186560|NCT01427751|E2|Reported Event|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
186561|NCT01427751|E1|Reported Event|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
186562|NCT01427738|B3|Baseline|Total|Total of all reporting groups
186563|NCT01427738|B2|Baseline|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
186564|NCT01427738|B1|Baseline|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
186565|NCT01427738|P2|Participant Flow|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
186566|NCT01427738|P1|Participant Flow|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
186567|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
186568|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
186569|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
186570|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
186571|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
186572|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
186573|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
186574|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
186575|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
186576|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
186577|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
186578|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
186579|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
186709|NCT01426789|B1|Baseline|Secukinumab|10 mg/kg intravenous (I.V.)
186716|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
186580|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
186581|NCT01427738|E2|Reported Event|Nystatin|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
186582|NCT01427738|E1|Reported Event|Gentian Violet|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
186583|NCT01427517|B4|Baseline|Total|Total of all reporting groups
186584|NCT01427517|B3|Baseline|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
186585|NCT01427517|B2|Baseline|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
186586|NCT01427517|B1|Baseline|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
186587|NCT01427517|P3|Participant Flow|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
186588|NCT01427517|P2|Participant Flow|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
186589|NCT01427517|P1|Participant Flow|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
186590|NCT01427517|O3|Outcome|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
186591|NCT01427517|O2|Outcome|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
186592|NCT01427517|O1|Outcome|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
186593|NCT01427517|E3|Reported Event|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
186594|NCT01427517|E2|Reported Event|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
186595|NCT01427517|E1|Reported Event|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
186596|NCT01427504|B7|Baseline|Total|Total of all reporting groups
186597|NCT01427504|B6|Baseline|Sequence 3b|Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.
186598|NCT01427504|B5|Baseline|Sequence 3a|Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.
186599|NCT01427504|B4|Baseline|Sequence 2b|Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.
186600|NCT01427504|B3|Baseline|Sequence 2a|Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.
186601|NCT01427504|B2|Baseline|Sequence 1b|Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.
186602|NCT01427504|B1|Baseline|Sequence 1a|Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.
186603|NCT01427504|P6|Participant Flow|Sequence 3b|Sequence 3,2,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
186604|NCT01427504|P5|Participant Flow|Sequence 3a|Sequence 3,1,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
186605|NCT01427504|P4|Participant Flow|Sequence 2b|Sequence 2,3,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
186606|NCT01427504|P3|Participant Flow|Sequence 2a|Sequence 2,1,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
186607|NCT01427504|P2|Participant Flow|Sequence 1b|Sequence 1,3,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
186608|NCT01427504|P1|Participant Flow|Sequence 1a|Sequence 1,2,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
186609|NCT01427504|O1|Outcome|Etravirine Cmin Coadministered With Boceprevir|Geometric mean ratio of etravirine Cmin when coadministered with boceprevir
186610|NCT01427504|O1|Outcome|Etravirine Cmax|Geometric mean ratio of etravirine Cmax when coadministered with boceprevir
186611|NCT01427504|O1|Outcome|Etravirine AUC Coadministered With Boceprevir|Geometric mean ratio of etravirine AUC when coadministered with boceprevir
186612|NCT01427504|O1|Outcome|Boceprevir C8 Coadministered With Etravirine|Geometric mean ratio of boceprevir C8 when coadministered with etravirine
186613|NCT01427504|O1|Outcome|Boceprevir Cmax Coadministered With Etravirine|Geometric mean ratio of boceprevir Cmax when coadministered with etravirine
186614|NCT01427504|O1|Outcome|Boceprevir AUC Coadministered With Etravirine|Geometric mean ratio of boceprevir AUC when coadministered with etravirine
186615|NCT01427504|O1|Outcome|Etravirine Cmin|Geometric mean of etravirine Cmin when administered alone.
186616|NCT01427504|O1|Outcome|Etravirine Cmax|Geometric mean of etravirine Cmax when administered alone.
186617|NCT01427504|O1|Outcome|Etravirine AUC|Geometric mean of etravirine AUC when administered alone.
186618|NCT01427504|O1|Outcome|Boceprevir C8|Geometric mean of boceprevir Cmax when administered alone.
186619|NCT01427504|O1|Outcome|Boceprevir Cmax|Geometric mean of boceprevir Cmax when administered alone.
186620|NCT01427504|O1|Outcome|Boceprevir AUC|Geometric mean of boceprevir AUC administered alone.
186717|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
186621|NCT01427504|E3|Reported Event|Boceprevir Coadministered With Etravirine|Boceprevir, 800 mg thrice daily, coadministered with etravirine, 200 mg twice daily for 10-14 days.
186622|NCT01427504|E2|Reported Event|Etravirine Alone|Subjects took etravirine alone, 200 mg twice daily, for 10-14 days
186623|NCT01427504|E1|Reported Event|Boceprevir Alone|Subjects took boceprevir alone, 800 mg thrice daily, for 10-14 days.
186624|NCT01427309|B5|Baseline|Total|Total of all reporting groups
186625|NCT01427309|B4|Baseline|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
186626|NCT01427309|B3|Baseline|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186627|NCT01427309|B2|Baseline|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
186628|NCT01427309|B1|Baseline|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186629|NCT01427309|P4|Participant Flow|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
186630|NCT01427309|P3|Participant Flow|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186631|NCT01427309|P2|Participant Flow|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
186632|NCT01427309|P1|Participant Flow|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186633|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
186634|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186635|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
186636|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186637|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
186638|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186639|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
186640|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186641|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
186642|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186643|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
186644|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186645|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
186646|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186647|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
186648|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186649|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
186650|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186651|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
186652|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186653|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
186654|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186655|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
186656|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186657|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
186658|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186659|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
186660|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186661|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
186662|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186663|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
186664|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186665|NCT01427309|E4|Reported Event|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
186666|NCT01427309|E3|Reported Event|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186667|NCT01427309|E2|Reported Event|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
186668|NCT01427309|E1|Reported Event|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
186669|NCT01426958|B1|Baseline|Overall Study|This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.
186670|NCT01426958|P1|Participant Flow|All Participants|This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.
186718|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
186671|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
186672|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
186673|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
186674|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
186675|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
186676|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
186677|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
186678|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
186679|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
186680|NCT01426958|E3|Reported Event|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
186681|NCT01426958|E2|Reported Event|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
186682|NCT01426958|E1|Reported Event|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
186683|NCT01426867|B4|Baseline|Total|Total of all reporting groups
186684|NCT01426867|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
186685|NCT01426867|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
186686|NCT01426867|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
186687|NCT01426867|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
186688|NCT01426867|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
186689|NCT01426867|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
186690|NCT01426867|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
186691|NCT01426867|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
186692|NCT01426867|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
186693|NCT01426867|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
186694|NCT01426867|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
186695|NCT01426867|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
186696|NCT01426854|B3|Baseline|Total|Total of all reporting groups
186697|NCT01426854|B2|Baseline|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
186698|NCT01426854|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
186699|NCT01426854|P2|Participant Flow|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
186700|NCT01426854|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
186701|NCT01426854|O2|Outcome|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
186702|NCT01426854|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
186703|NCT01426854|O2|Outcome|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
186704|NCT01426854|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
186705|NCT01426854|E2|Reported Event|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
186706|NCT01426854|E1|Reported Event|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
186707|NCT01426789|B3|Baseline|Total|Total of all reporting groups
186724|NCT01426789|E4|Reported Event|Group 3|Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
186725|NCT01426789|E3|Reported Event|Group 1|Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
186726|NCT01426789|E2|Reported Event|Placebo|Placebo i.v.
186727|NCT01426789|E1|Reported Event|Secukinumab|10mg/kg i.v.
186728|NCT01426763|B3|Baseline|Total|Total of all reporting groups
186729|NCT01426763|B2|Baseline|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
186730|NCT01426763|B1|Baseline|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
186731|NCT01426763|P2|Participant Flow|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
186732|NCT01426763|P1|Participant Flow|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous (SC) injection of 1000 Units of CINRYZE with 20,000 Units of recombinant human hyaluronidase (rHuPH20) twice weekly for two weeks
186733|NCT01426763|O2|Outcome|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
186734|NCT01426763|O1|Outcome|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
186735|NCT01426763|E2|Reported Event|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
186736|NCT01426763|E1|Reported Event|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
186737|NCT01426555|B3|Baseline|Total|Total of all reporting groups
186738|NCT01426555|B2|Baseline|Rowing Arm|Thirty five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
186739|NCT01426555|B1|Baseline|ZA Infusion Arm|Thirty five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
186740|NCT01426555|P2|Participant Flow|ZA Infusion Arm|"Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.
In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.
After the observation period, subjects in the FES rowing plus zoledronic acid arm were planned to receive Zoledronic Acid (Reclast ®) administered as a dose of 5mg intravenously.
All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program."
186741|NCT01426555|P1|Participant Flow|Rowing Arm|"Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.
In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.
All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program."
186742|NCT01426555|O2|Outcome|Rowing Arm|"Thirty Five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI, enrolled.
Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB."
186743|NCT01426555|O1|Outcome|ZA Infusion Arm|"Thirty Five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI, were enrolled.
Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB."
186744|NCT01426555|O2|Outcome|Rowing Arm|"Thirty Five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were planned to be enrolled.
No Data was analyzed because dataset is not available to VABHS Study team."
186745|NCT01426555|O1|Outcome|ZA Infusion Arm|"Thirty Five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were planned to be enrolled.
No Data was analyzed because dataset is not available to VABHS Study team."
186746|NCT01426555|E2|Reported Event|Rowing Arm|No adverse event data were available for the remaining 16 participants.
186747|NCT01426555|E1|Reported Event|ZA Infusion Arm|No adverse event data were available for the remaining 9 participants.
186748|NCT01426516|B3|Baseline|Total|Total of all reporting groups
186749|NCT01426516|B2|Baseline|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.
Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
186750|NCT01426516|B1|Baseline|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
186751|NCT01426516|P2|Participant Flow|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.
Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
186752|NCT01426516|P1|Participant Flow|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
186753|NCT01426516|O2|Outcome|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.
Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
186754|NCT01426516|O1|Outcome|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
186755|NCT01426516|E2|Reported Event|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.
Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
186870|NCT01426230|P2|Participant Flow|Open Label - Cohort <=70 Yrs Old|"Cohort by age-
- Patients <=70 Yrs old"
186756|NCT01426516|E1|Reported Event|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
186757|NCT01426438|B3|Baseline|Total|Total of all reporting groups
186758|NCT01426438|B2|Baseline|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186759|NCT01426438|B1|Baseline|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186760|NCT01426438|P2|Participant Flow|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186761|NCT01426438|P1|Participant Flow|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186762|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186763|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186764|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186765|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186766|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186767|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186768|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186769|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186770|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186771|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186772|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186773|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186774|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186775|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186776|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186777|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186778|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186779|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186780|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186781|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186782|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186783|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
187110|NCT01425268|B3|Baseline|Total|Total of all reporting groups
186785|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186786|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186787|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186788|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186789|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
186790|NCT01426438|E2|Reported Event|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
186791|NCT01426438|E1|Reported Event|Arm A: Extended-release Niacin With Aspirin|Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
186792|NCT01426425|B1|Baseline|mITT Set|The modified intent-to-treat (mITT) set.
186793|NCT01426425|P1|Participant Flow|All Participants|All subjects enrolled into the study.
186794|NCT01426425|O1|Outcome|mITT Subjects With Acute Procedural Success|The modified intent-to-treat (mITT) subjects who had acute procedural success with cryoablation for the treatment of AVNRT.
186795|NCT01426425|O1|Outcome|mITT Set|The modified intent-to-treat (mITT) set.
186796|NCT01426425|O1|Outcome|mITT Set|The modified intent-to-treat (mITT) set.
186797|NCT01426425|E1|Reported Event|mITT Set|Subjects in the modified intent-to-treat (mITT) set.
186798|NCT01426373|B1|Baseline|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186799|NCT01426373|P1|Participant Flow|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186800|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186801|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186802|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186803|NCT01426373|O2|Outcome|Month 12 After Last Treatment|
186804|NCT01426373|O1|Outcome|Month 3 After Last Treatment|
186805|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186806|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186807|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186808|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186809|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186810|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186811|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186812|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186813|NCT01426373|E1|Reported Event|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
186814|NCT01426360|B3|Baseline|Total|Total of all reporting groups
186815|NCT01426360|B2|Baseline|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
186816|NCT01426360|B1|Baseline|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
186817|NCT01426360|P2|Participant Flow|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
186818|NCT01426360|P1|Participant Flow|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
186819|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
186820|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
186821|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
186822|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
186823|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
186824|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
186825|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
186826|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
186827|NCT01426360|E2|Reported Event|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
186828|NCT01426360|E1|Reported Event|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
186829|NCT01426347|B3|Baseline|Total|Total of all reporting groups
186830|NCT01426347|B2|Baseline|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.
Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
186831|NCT01426347|B1|Baseline|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.
Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.
Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
186832|NCT01426347|P2|Participant Flow|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.
Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
186833|NCT01426347|P1|Participant Flow|Placebo Group|"Rheumatoid Arthritis (RA) patients with vitamin D deficiency will be randomized to placebo and active intervention arms.
Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.
Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
186834|NCT01426347|O2|Outcome|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.
Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
186835|NCT01426347|O1|Outcome|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.
Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.
Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
186836|NCT01426347|O2|Outcome|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.
Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
186837|NCT01426347|O1|Outcome|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.
Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.
Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
186838|NCT01426347|E2|Reported Event|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.
Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
186839|NCT01426347|E1|Reported Event|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.
Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.
Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
186840|NCT01426269|B1|Baseline|Period 1: Oral Doxycycline and Topical Metronidazole|"Subjects will receive oral doxycycline and topical metronidazole during period 1 (12 weeks)
Oral Doxycycline and Topical Metronidazole: period 1, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area"
186841|NCT01426269|P3|Participant Flow|Placebo|"Subjects will receive placebo during phase 2 (week 12 – week 52)
Placebo: During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning"
186842|NCT01426269|P2|Participant Flow|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during phase 2 (week 12 - week 52)
Oral Doxycycline: During phase 2 week 12 - week 52: Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
187506|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
186843|NCT01426269|P1|Participant Flow|Doxycycline and Metronidazole Regimen|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
Oral Doxycycline and Topical Metronidazole: During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area.
After Period 1, subjects who meet criteria for phase 2 will be randomized to receive doxycycline or placebo during phase 2"
186844|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186845|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186846|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186847|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186848|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186849|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186850|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186851|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186852|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186853|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186854|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186855|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
186856|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.
Placebo: During period 2, placebo, oral, one capsule daily in the morning"
186857|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.
Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
186858|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.
Placebo: During period 2, placebo, oral, one capsule daily in the morning"
186859|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.
Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
186860|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.
Placebo: During period 2, placebo, oral, one capsule daily in the morning"
186861|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.
Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
186862|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.
Placebo: During period 2, placebo, oral, one capsule daily in the morning"
186863|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.
Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
186864|NCT01426269|E3|Reported Event|Period 2: Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.
Placebo: period 2, placebo, oral, one capsule daily in the morning"
186865|NCT01426269|E2|Reported Event|Period 2: Oral Doxycycline|"Subjects will receive oral doxycycline during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.
Oral Doxycycline: period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
186866|NCT01426269|E1|Reported Event|Period 1: Oral Doxycycline and Topical Metronidazole|"Subjects will receive oral doxycycline and topical metronidazole during period 1 (12 weeks)
Oral Doxycycline and Topical Metronidazole: period 1, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area"
186867|NCT01426230|B3|Baseline|Total|Total of all reporting groups
186871|NCT01426230|P1|Participant Flow|Open Label - Cohort >70 Yrs Old|"Cohort by age-
- Patients >70 Yrs old"
186872|NCT01426230|O2|Outcome|Open Label - Cohort <=70 Yrs Old|"Cohort by age-
- Patients <=70 Yrs old"
186873|NCT01426230|O1|Outcome|Open Label - Cohort >70 Yrs Old|"Cohort by age-
- Patients >70 Yrs old"
186874|NCT01426230|E1|Reported Event|Open Label - Both Cohorts|
186875|NCT01426113|B3|Baseline|Total|Total of all reporting groups
186876|NCT01426113|B2|Baseline|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
186877|NCT01426113|B1|Baseline|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
186878|NCT01426113|P2|Participant Flow|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
186879|NCT01426113|P1|Participant Flow|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
186880|NCT01426113|O2|Outcome|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
186881|NCT01426113|O1|Outcome|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
186882|NCT01426113|E2|Reported Event|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
186883|NCT01426113|E1|Reported Event|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
186884|NCT01425879|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
186885|NCT01425879|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
186886|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
186887|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
186888|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
186889|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
186890|NCT01425879|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
186891|NCT01425853|B3|Baseline|Total|Total of all reporting groups
186892|NCT01425853|B2|Baseline|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186893|NCT01425853|B1|Baseline|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186894|NCT01425853|P2|Participant Flow|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186895|NCT01425853|P1|Participant Flow|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186896|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186897|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186898|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
187507|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
186899|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186900|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186901|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186902|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186903|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186904|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186905|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186906|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186907|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186908|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186909|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186910|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186911|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186912|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186913|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186914|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186915|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186916|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186917|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186918|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186919|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186920|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186921|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186922|NCT01425853|E2|Reported Event|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib"
186923|NCT01425853|E1|Reported Event|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride"
186924|NCT01425814|B1|Baseline|Overall Population|All patients who were randomized and received at least one dose of investigational medicinal product
186925|NCT01425814|P6|Participant Flow|Sequence F|Placebo - Indacaterol 150 μg - LAS100977 5 μg - LAS100977 10 μg - LAS100977 2.5 μg - LAS100977 0.625 μg
186926|NCT01425814|P5|Participant Flow|Sequence E|LAS100977 5 μg - Placebo - LAS100977 2.5 μg - Indacaterol 150 μg - LAS100977 0.625 μg - LAS100977 10 μg
186927|NCT01425814|P4|Participant Flow|Sequence D|LAS100977 2.5 μg - LAS100977 5 μg - LAS100977 0.625 μg - Placebo - LAS100977 10 μg - Indacaterol 150 μg
186928|NCT01425814|P3|Participant Flow|Sequence C|LAS100977 0.625 μg - LAS100977 2.5 μg - LAS100977 10 μg - LAS100977 5 μg - Indacaterol 150 μg - Placebo
186929|NCT01425814|P2|Participant Flow|Sequence B|LAS100977 10 μg - LAS100977 0.625 μg - Indacaterol 150 μg - LAS100977 2.5 μg - Placebo - LAS100977 5 μg
186930|NCT01425814|P1|Participant Flow|Sequence A|Indacaterol 150 μg - LAS100977 10 μg - Placebo - LAS100977 0.625 μg - LAS100977 5 μg- LAS100977 2.5 μg
186931|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186932|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186933|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
186934|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
186935|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
186936|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
186937|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186938|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186939|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
186940|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
186941|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
186942|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
186943|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186944|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186945|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
186946|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
186947|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
186948|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
186949|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186950|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186951|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
186952|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
186953|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
186954|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
186955|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186956|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186957|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
186958|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
186959|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
186960|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
186961|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186962|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186963|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
186964|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
186965|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
186966|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
186967|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186968|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186969|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
186970|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
186971|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
186972|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
186973|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186974|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186975|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
186976|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
186977|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
186978|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
186979|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186980|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186981|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
186982|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
186983|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
186984|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
186985|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186986|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186987|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
186988|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
186989|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
186990|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
186991|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186992|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186993|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
186994|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
186995|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
186996|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
186997|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
186998|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
186999|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
187000|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
187001|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
187002|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
187003|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
187004|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
187005|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
187006|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
187007|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
187008|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
187009|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
187010|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
187011|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
187012|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
187013|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
187014|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
187015|NCT01425814|E6|Reported Event|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
187016|NCT01425814|E5|Reported Event|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
187017|NCT01425814|E4|Reported Event|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
187018|NCT01425814|E3|Reported Event|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
187019|NCT01425814|E2|Reported Event|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
187020|NCT01425814|E1|Reported Event|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
187021|NCT01425749|B3|Baseline|Total|Total of all reporting groups
187022|NCT01425749|B2|Baseline|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187023|NCT01425749|B1|Baseline|Arm A|"Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187024|NCT01425749|P2|Participant Flow|Arm B: Intradermal/Subcutaneous Injections|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187025|NCT01425749|P1|Participant Flow|Arm A: Intramuscular Injections|"Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187026|NCT01425749|O1|Outcome|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187027|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187028|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections of recMAGE-A3 + AS15 ASCI.
recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187214|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
187029|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187030|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187031|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187032|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187033|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187034|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187035|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187036|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187037|NCT01425749|E2|Reported Event|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187038|NCT01425749|E1|Reported Event|Arm A|"Intramuscular injections of recMAGE-A3 + AS15 ASCI.
recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
187039|NCT01425632|B4|Baseline|Total|Total of all reporting groups
187040|NCT01425632|B3|Baseline|Placebo|TAU-284 placebo twice daily for 2 weeks
187041|NCT01425632|B2|Baseline|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
187042|NCT01425632|B1|Baseline|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
187043|NCT01425632|P3|Participant Flow|Placebo|TAU-284 placebo twice daily for 2 weeks
187044|NCT01425632|P2|Participant Flow|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
187045|NCT01425632|P1|Participant Flow|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
187046|NCT01425632|O3|Outcome|Placebo|TAU-284 placebo twice daily for 2 weeks
187047|NCT01425632|O2|Outcome|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
187048|NCT01425632|O1|Outcome|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
187049|NCT01425632|E3|Reported Event|Placebo|TAU-284 placebo twice daily for 2 weeks
187050|NCT01425632|E2|Reported Event|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
187051|NCT01425632|E1|Reported Event|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
187052|NCT01425528|B3|Baseline|Total|Total of all reporting groups
187053|NCT01425528|B2|Baseline|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.
Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
187054|NCT01425528|B1|Baseline|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.
Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
187055|NCT01425528|P2|Participant Flow|Cohort 2|Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.
187056|NCT01425528|P1|Participant Flow|Cohort 1|This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.
187057|NCT01425528|O2|Outcome|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.
Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
187111|NCT01425268|B2|Baseline|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline
Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
187508|NCT01424228|E2|Reported Event|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187058|NCT01425528|O1|Outcome|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.
Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
187059|NCT01425528|E2|Reported Event|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.
Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
187060|NCT01425528|E1|Reported Event|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.
Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
187061|NCT01425463|B3|Baseline|Total|Total of all reporting groups
187062|NCT01425463|B2|Baseline|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
187063|NCT01425463|B1|Baseline|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Polyferose: Administered orally with water."
187064|NCT01425463|P2|Participant Flow|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
187065|NCT01425463|P1|Participant Flow|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Polyferose: Administered orally with water."
187066|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
187067|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Polyferose: Administered orally with water."
187068|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
187069|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Polyferose: Administered orally with water."
187070|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
187071|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Polyferose: Administered orally with water."
187072|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
187073|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Polyferose: Administered orally with water."
187074|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
187075|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Polyferose: Administered orally with water."
187076|NCT01425463|E2|Reported Event|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
187077|NCT01425463|E1|Reported Event|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Polyferose: Administered orally with water."
187078|NCT01425359|B3|Baseline|Total|Total of all reporting groups
187079|NCT01425359|B2|Baseline|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
187080|NCT01425359|B1|Baseline|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
187081|NCT01425359|P2|Participant Flow|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
187082|NCT01425359|P1|Participant Flow|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
187083|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
187084|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
187085|NCT01425359|O2|Outcome|Qualifying Phase: Participants Entered a 2-week Washout Period|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
187086|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
187087|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
187143|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
187509|NCT01424228|E1|Reported Event|Placebo|Tablet once daily before breakfast
187088|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
187089|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
187090|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
187091|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
187092|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
187093|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
187094|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
187095|NCT01425359|E2|Reported Event|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
187096|NCT01425359|E1|Reported Event|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.
Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
187097|NCT01425307|B3|Baseline|Total|Total of all reporting groups
187098|NCT01425307|B2|Baseline|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid
Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
187099|NCT01425307|B1|Baseline|Standard Therapy|Standard Therapy of monthly transfusions
187100|NCT01425307|P2|Participant Flow|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid
Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
187101|NCT01425307|P1|Participant Flow|Standard Therapy|Standard Therapy of monthly transfusions
187102|NCT01425307|O2|Outcome|Treatment Arm|Hydroxyurea will be provided as capsules and liquid
187103|NCT01425307|O1|Outcome|Standard Therapy|Standard Therapy of monthly transfusions
187104|NCT01425307|O2|Outcome|Treatment Arm|Hydroxyurea will be provided as capsules and liquid
187105|NCT01425307|O1|Outcome|Standard Therapy|Standard Therapy of monthly transfusions
187106|NCT01425307|O2|Outcome|Standard Therapy|Standard Therapy of monthly transfusions
187107|NCT01425307|O1|Outcome|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid
Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
187108|NCT01425307|E2|Reported Event|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid
Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
187109|NCT01425307|E1|Reported Event|Standard Therapy|Standard Therapy of monthly transfusions
187112|NCT01425268|B1|Baseline|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control
AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
187113|NCT01425268|P2|Participant Flow|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline
Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
187114|NCT01425268|P1|Participant Flow|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control
AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
187115|NCT01425268|O2|Outcome|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline
Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
187116|NCT01425268|O1|Outcome|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control
AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
187117|NCT01425268|O2|Outcome|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline
Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
187118|NCT01425268|O1|Outcome|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control
AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
187119|NCT01425268|E2|Reported Event|Saline Tissue Expansion|"Saline Tissue Expansion inflated by needle injections of saline
Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline."
187120|NCT01425268|E1|Reported Event|AeroForm Tissue Expansion|"AeroForm Tissue Expansion inflation with carbon dioxide by remote control
AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander."
187121|NCT01425229|B1|Baseline|Bosentan|Bosentan PK
187122|NCT01425229|P1|Participant Flow|Bosentan|Bosentan pharmacokinetics
187123|NCT01425229|O3|Outcome|Bosentan During Clarithromycin|administration of bosentan 125 mg p.o. b.i.d. on day 11-14 and administration of clarithromycin 500 mg p.o b.i.d. on day 11-14
187124|NCT01425229|O2|Outcome|Bosentan at Steady-state|administration of bosentan 125 mg p.o. b.i.d. on day 2-10
187125|NCT01425229|O1|Outcome|Bosentan After First Dose|administration of bosentan 125 mg p.o. single dose
187126|NCT01425229|O3|Outcome|Bosentan During Clarithromycin|administration of bosentan 125 mg p.o. b.i.d. on day 11-14 and administration of clarithromycin 500 mg p.o b.i.d. on day 11-14
187127|NCT01425229|O2|Outcome|Bosentan at Steady-state|administration of bosentan 125 mg p.o. b.i.d. on day 2-10
187128|NCT01425229|O1|Outcome|Bosentan After First Dose|administration of bosentan 125 mg p.o. single dose
187129|NCT01425229|E3|Reported Event|Bosentan During Clarithromycin|Bosentan PK during clarithromycin
187130|NCT01425229|E2|Reported Event|Bosentan at Steady-state|Bosentan PK at steady-state
187131|NCT01425229|E1|Reported Event|Bosentan After First Dose|Bosentan PK after first dose
187132|NCT01425203|B3|Baseline|Total|Total of all reporting groups
187133|NCT01425203|B2|Baseline|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
187134|NCT01425203|B1|Baseline|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
187135|NCT01425203|P3|Participant Flow|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
187136|NCT01425203|P2|Participant Flow|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
187137|NCT01425203|P1|Participant Flow|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
187138|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
187139|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
187140|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
187141|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
187142|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
187510|NCT01424189|B3|Baseline|Total|Total of all reporting groups
187144|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
187145|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
187146|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
187147|NCT01425203|E3|Reported Event|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
187148|NCT01425203|E2|Reported Event|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
187149|NCT01425203|E1|Reported Event|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
187150|NCT01425190|B4|Baseline|Total|Total of all reporting groups
187151|NCT01425190|B3|Baseline|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187152|NCT01425190|B2|Baseline|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187153|NCT01425190|B1|Baseline|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187154|NCT01425190|P3|Participant Flow|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187155|NCT01425190|P2|Participant Flow|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187156|NCT01425190|P1|Participant Flow|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187157|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187158|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187159|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187160|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187161|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187162|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187186|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
187163|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187164|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187165|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187166|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187167|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187168|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187169|NCT01425190|E3|Reported Event|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187170|NCT01425190|E2|Reported Event|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187171|NCT01425190|E1|Reported Event|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
187172|NCT01424943|B3|Baseline|Total|Total of all reporting groups
187173|NCT01424943|B2|Baseline|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
187174|NCT01424943|B1|Baseline|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
187175|NCT01424943|P2|Participant Flow|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
187176|NCT01424943|P1|Participant Flow|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
187177|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
187178|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
187179|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
187180|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
187181|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
187182|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
187183|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
187184|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
187185|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
187187|NCT01424943|E2|Reported Event|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
187431|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
187188|NCT01424943|E1|Reported Event|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
187189|NCT01424930|B3|Baseline|Total|Total of all reporting groups
187190|NCT01424930|B2|Baseline|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
187191|NCT01424930|B1|Baseline|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
187192|NCT01424930|P2|Participant Flow|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
187193|NCT01424930|P1|Participant Flow|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
187194|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
187195|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
187196|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
187197|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
187198|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
187199|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
187200|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
187201|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
187202|NCT01424930|E2|Reported Event|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
187203|NCT01424930|E1|Reported Event|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
187204|NCT01424813|B3|Baseline|Total|Total of all reporting groups
187205|NCT01424813|B2|Baseline|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
187206|NCT01424813|B1|Baseline|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
187207|NCT01424813|P2|Participant Flow|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
187208|NCT01424813|P1|Participant Flow|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
187209|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
187210|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
187211|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
187212|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
187213|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
187432|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
187215|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
187216|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
187217|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
187218|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
187219|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
187220|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
187221|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
187222|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
187223|NCT01424813|E2|Reported Event|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
187224|NCT01424813|E1|Reported Event|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
187225|NCT01424644|B3|Baseline|Total|Total of all reporting groups
187226|NCT01424644|B2|Baseline|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187227|NCT01424644|B1|Baseline|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187228|NCT01424644|P2|Participant Flow|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187229|NCT01424644|P1|Participant Flow|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187230|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187231|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187232|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187233|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187234|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187235|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187236|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187237|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187238|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187239|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187240|NCT01424644|E2|Reported Event|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187241|NCT01424644|E1|Reported Event|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
187242|NCT01424501|B7|Baseline|Total|Total of all reporting groups
187243|NCT01424501|B6|Baseline|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187244|NCT01424501|B5|Baseline|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187245|NCT01424501|B4|Baseline|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187246|NCT01424501|B3|Baseline|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187247|NCT01424501|B2|Baseline|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187433|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
187248|NCT01424501|B1|Baseline|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187249|NCT01424501|P6|Participant Flow|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187250|NCT01424501|P5|Participant Flow|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187251|NCT01424501|P4|Participant Flow|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187252|NCT01424501|P3|Participant Flow|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187253|NCT01424501|P2|Participant Flow|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187254|NCT01424501|P1|Participant Flow|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187255|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187256|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187257|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187258|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187259|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187260|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187261|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187262|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187263|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187264|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187265|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187266|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187267|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187268|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187269|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187270|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187271|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187272|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187273|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187274|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187275|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187276|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187277|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187278|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187279|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187280|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187281|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187282|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187283|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187284|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187285|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187286|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187287|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187288|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187289|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187290|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187291|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187292|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187293|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187294|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187295|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187296|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187297|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187298|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187299|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187300|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187301|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187302|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187303|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187304|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187305|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187306|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187307|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187434|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
187308|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187309|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187310|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187311|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187312|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187313|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187314|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187315|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187316|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187317|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187318|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187319|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187320|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187321|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187322|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187323|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187324|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187325|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187326|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187327|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187328|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187329|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187330|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187331|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187332|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187333|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187334|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187335|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187336|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187337|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187435|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
187338|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187339|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187340|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187341|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187342|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187343|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187344|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187345|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187346|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187347|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187348|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187349|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187350|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187351|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187352|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187353|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187354|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187355|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187356|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187357|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187358|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187359|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187360|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187361|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187362|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187363|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187364|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187365|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187366|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187367|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187436|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
187368|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187369|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187370|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187371|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187372|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187373|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187374|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187375|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187376|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187377|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187378|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187379|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187380|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187381|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187382|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187383|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187384|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187385|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187386|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187387|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187388|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187389|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187390|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187391|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187392|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187393|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187394|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187395|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187396|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187397|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187437|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
187398|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1
187399|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187400|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187401|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187402|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187403|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187404|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187405|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187406|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187407|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187408|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187409|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187410|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187411|NCT01424501|E6|Reported Event|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187412|NCT01424501|E5|Reported Event|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187413|NCT01424501|E4|Reported Event|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187414|NCT01424501|E3|Reported Event|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187415|NCT01424501|E2|Reported Event|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
187416|NCT01424501|E1|Reported Event|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
187417|NCT01424306|B1|Baseline|Study Subjects|All six treatment orders combined
187418|NCT01424306|P6|Participant Flow|Glucose - HFCS - Fructose|"Subjects treated in the order glucose-sweetened beverage - wash out - HFCS-sweetened beverage- wash out - fructose-sweetened beverage
Treatments each lasted 8 days and were separated by a 20-day washout."
187419|NCT01424306|P5|Participant Flow|Glucose - Fructose - HFCS|"Subjects treated in the order glucose-sweetened beverage - wash out - fructose-sweetened beverage- wash out - HFCS-sweetened beverage
Treatments each lasted 8 days and were separated by a 20-day washout."
187420|NCT01424306|P4|Participant Flow|HFCS - Glucose - Fructose|"Subjects treated in the order HFCS-sweetened beverage - wash out - glucose-sweetened beverage- wash out - fructose-sweetened beverage
Treatments each lasted 8 days and were separated by a 20-day washout."
187421|NCT01424306|P3|Participant Flow|HFCS - Fructose - Glucose|"Subjects treated in the order HFCS-sweetened beverage - wash out - fructose-sweetened beverage- wash out - glucose-sweetened beverage
Treatments each lasted 8 days and were separated by a 20-day washout."
187422|NCT01424306|P2|Participant Flow|Fructose - HFCS - Glucose|"Subjects treated in the order fructose-sweetened beverage - wash out - HFCS-sweetened beverage- wash out - glucose-sweetened beverage
Treatments each lasted 8 days and were separated by a 20-day washout."
187423|NCT01424306|P1|Participant Flow|Fructose - Glucose - HFCS|"Subjects treated in the order fructose-sweetened beverage - wash out - glucose-sweetened beverage- wash out - HFCS-sweetened beverage
Treatments each lasted 8 days and were separated by a 20-day washout."
187424|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
187425|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
187426|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
187427|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
187428|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
187429|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
187430|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
187438|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
187439|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Gene expression measured on day 9 of HFCS-sweetened beverage intervention period
187440|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Gene expression measured on day 9 of glucose-sweetened beverage intervention period
187441|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Gene expression measured on day 9 of fructose-sweetened beverage intervention period
187442|NCT01424306|O3|Outcome|HFCS Arm - Day 9|LBP measured on day 9 of HFCS-sweetened beverage intervention period
187443|NCT01424306|O2|Outcome|Glucose Arm - Day 9|LBP measured on day 9 of glucose-sweetened beverage intervention period
187444|NCT01424306|O1|Outcome|Fructose Arm - Day 9|LBP measured on day 9 of fructose-sweetened beverage intervention period
187445|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Zonulin measured on day 9 of HFCS-sweetened beverage intervention period
187446|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Zonulin measured on day 9 of glucose-sweetened beverage intervention period
187447|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Zonulin measured on day 9 of fructose-sweetened beverage intervention period
187448|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Lactulose:Mannitol ratio measured on day 9 of HFCS-sweetened beverage intervention period
187449|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Lactulose:Mannitol ratio measured on day 9 of glucose-sweetened beverage intervention period
187450|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Lactulose:Mannitol ratio measured on day 9 of fructose-sweetened beverage intervention period
187451|NCT01424306|O3|Outcome|HFCS Arm|Average total energy consumed each day during the HFCS-sweetened beverage intervention period
187452|NCT01424306|O2|Outcome|Glucose Arm|Average total energy consumed each day during the glucose-sweetened beverage intervention period
187453|NCT01424306|O1|Outcome|Fructose Arm|Average total energy consumed each day during the fructose-sweetened beverage intervention period
187454|NCT01424306|O3|Outcome|HFCS Arm - Day 9|Adiponectin measured on day 9 of HFCS-sweetened beverage intervention period
187455|NCT01424306|O2|Outcome|Glucose Arm - Day 9|Adiponectin measured on day 9 of glucose-sweetened beverage intervention period
187456|NCT01424306|O1|Outcome|Fructose Arm - Day 9|Adiponectin measured on day 9 of fructose-sweetened beverage intervention period
187457|NCT01424306|O3|Outcome|HFCS Arm - Day 9|IL-6 measured on day 9 of HFCS-sweetened beverage intervention period
187458|NCT01424306|O2|Outcome|Glucose Arm - Day 9|IL-6 measured on day 9 of glucose-sweetened beverage intervention period
187459|NCT01424306|O1|Outcome|Fructose Arm - Day 9|IL-6 measured on day 9 of fructose-sweetened beverage intervention period
187460|NCT01424306|O6|Outcome|HFCS Arm - Day 9|CRP measured on day 9 of HFCS-sweetened beverage intervention period
187461|NCT01424306|O5|Outcome|HFCS Arm - Day 1|CRP measured on day 1 of HFCS-sweetened beverage intervention period
187462|NCT01424306|O4|Outcome|Glucose Arm - Day 9|CRP measured on day 9 of glucose-sweetened beverage intervention period
187463|NCT01424306|O3|Outcome|Glucose Arm - Day 1|CRP measured on day 1 of glucose-sweetened beverage intervention period
187464|NCT01424306|O2|Outcome|Fructose Arm - Day 9|CRP measured on day 9 of fructose-sweetened beverage intervention period
187465|NCT01424306|O1|Outcome|Fructose Arm - Day 1|CRP measured on day 1 of fructose-sweetened beverage intervention period
187466|NCT01424306|E3|Reported Event|HFCS Arm|HFCS liquid mixed with powdered drink flavoring (Lemon) and aspartame to match sweetness
187467|NCT01424306|E2|Reported Event|Glucose Arm|Powdered dextrose mixed with powdered drink flavoring (Lemon) and aspartame to match sweetness
187468|NCT01424306|E1|Reported Event|Fructose Arm|Powdered fructose mixed with powdered drink flavoring (Lemon)
187469|NCT01424228|B3|Baseline|Total|Total of all reporting groups
187470|NCT01424228|B2|Baseline|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187471|NCT01424228|B1|Baseline|Placebo|Tablet once daily before breakfast
187472|NCT01424228|P2|Participant Flow|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187473|NCT01424228|P1|Participant Flow|Placebo|Tablet once daily before breakfast
187474|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187475|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187476|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187477|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187478|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187479|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187480|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187481|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187482|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187483|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187484|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187485|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187486|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187487|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187488|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187489|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187490|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187491|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187492|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187493|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187494|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187495|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187496|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187497|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
187498|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
187511|NCT01424189|B2|Baseline|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
187512|NCT01424189|B1|Baseline|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
187513|NCT01424189|P2|Participant Flow|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
187514|NCT01424189|P1|Participant Flow|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
187515|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
187516|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
187517|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
187518|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
187519|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
187520|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
187521|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
187522|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
187523|NCT01424189|E2|Reported Event|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
187524|NCT01424189|E1|Reported Event|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
187525|NCT01424072|B4|Baseline|Total|Total of all reporting groups
187526|NCT01424072|B3|Baseline|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
187527|NCT01424072|B2|Baseline|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.
auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
187528|NCT01424072|B1|Baseline|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.
auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
187529|NCT01424072|P3|Participant Flow|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
187530|NCT01424072|P2|Participant Flow|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.
auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
187531|NCT01424072|P1|Participant Flow|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.
auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
187532|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
187533|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.
auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
187534|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.
auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
187535|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
187536|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.
auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
187537|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.
auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
187538|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
187539|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.
auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
187540|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.
auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
187541|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
187805|NCT01422720|P1|Participant Flow|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
187542|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.
auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
187543|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.
auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
187544|NCT01424072|E3|Reported Event|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
187545|NCT01424072|E2|Reported Event|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.
auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
187546|NCT01424072|E1|Reported Event|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.
auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
187547|NCT01424033|B1|Baseline|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.
N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
187548|NCT01424033|P1|Participant Flow|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.
N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
187549|NCT01424033|O1|Outcome|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.
N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
187550|NCT01424033|E1|Reported Event|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.
N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
187551|NCT01423916|B4|Baseline|Total|Total of all reporting groups
187552|NCT01423916|B3|Baseline|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
187553|NCT01423916|B2|Baseline|Brexpiprzole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187554|NCT01423916|B1|Baseline|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187555|NCT01423916|P3|Participant Flow|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
187556|NCT01423916|P2|Participant Flow|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187557|NCT01423916|P1|Participant Flow|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD (once daily) on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187558|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
187559|NCT01423916|O3|Outcome|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
187560|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants were randomised to 1 of 4 arms in a ratio of 2:2:1:1. On Day 1, all participants received brexpiprazole placebo tablets. Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187561|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants were randomised to 1 of 4 arms in a ratio of 2:2:1:1. On Day 1, all participants received brexpiprazole placebo tablets. Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187562|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
187563|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
187564|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187565|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187566|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
187567|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
187568|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187569|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187570|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
187571|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
187572|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187573|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187574|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
187575|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
187576|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187577|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187578|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
187579|NCT01423916|O3|Outcome|Moxifloaxcin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
187580|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187581|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187582|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
187583|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
187584|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187585|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187586|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
187587|NCT01423916|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
187588|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187589|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187590|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
187591|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187592|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187593|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
187594|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187595|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187596|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
187597|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187598|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187599|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
187600|NCT01423916|O3|Outcome|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
187601|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187602|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187603|NCT01423916|O3|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187604|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187605|NCT01423916|O1|Outcome|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
187606|NCT01423916|E4|Reported Event|Placebo|Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
187607|NCT01423916|E3|Reported Event|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
187608|NCT01423916|E2|Reported Event|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187609|NCT01423916|E1|Reported Event|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
187610|NCT01423773|B1|Baseline|Overall|Each product worn bilaterally for two consecutive days in either Period One or Period Two. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
187611|NCT01423773|P2|Participant Flow|Lotrafilcon A Control, Then Lotrafilcon A Test|Lotrafilcon A control contact lenses worn in Period One, with lotrafilcon A test contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
187612|NCT01423773|P1|Participant Flow|Lotrafilcon A Test, Then Lotrafilcon A Control|Lotrafilcon A test contact lenses worn in Period One, with lotrafilcon A control contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
187613|NCT01423773|O2|Outcome|Lotrafilcon A Control|Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
187614|NCT01423773|O1|Outcome|Lotrafilcon A Test|Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
187615|NCT01423773|E2|Reported Event|Lotrafilcon A Control|Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
187616|NCT01423773|E1|Reported Event|Lotrafilcon A Test|Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
187617|NCT01423760|B3|Baseline|Total|Total of all reporting groups
187618|NCT01423760|B2|Baseline|Multiple Myeloma|"Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide."
187619|NCT01423760|B1|Baseline|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
187620|NCT01423760|P2|Participant Flow|Multiple Myeloma|"Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide."
187621|NCT01423760|P1|Participant Flow|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
187657|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187658|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187622|NCT01423760|O2|Outcome|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
187623|NCT01423760|O1|Outcome|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
187624|NCT01423760|O2|Outcome|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
187625|NCT01423760|O1|Outcome|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
187626|NCT01423760|E2|Reported Event|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
187627|NCT01423760|E1|Reported Event|NSCLC|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
187628|NCT01423617|B3|Baseline|Total|Total of all reporting groups
187629|NCT01423617|B2|Baseline|Placebo|Placebo: 3 tablets 2 times daily
187630|NCT01423617|B1|Baseline|Zenoctil|Zenoctil: 3 tablets 2 times daily
187631|NCT01423617|P2|Participant Flow|Placebo|Placebo: 3 tablets 2 times daily
187632|NCT01423617|P1|Participant Flow|Zenoctil|Zenoctil: 3 tablets 2 times daily
187633|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
187634|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
187635|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
187636|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
187637|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
187638|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
187639|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
187640|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
187641|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
187642|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
187643|NCT01423617|E2|Reported Event|Placebo|Placebo: 3 tablets 2 times daily
187644|NCT01423617|E1|Reported Event|Zenoctil|Zenoctil: 3 tablets 2 times daily
187645|NCT01423604|B4|Baseline|Total|Total of all reporting groups
187646|NCT01423604|B3|Baseline|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187647|NCT01423604|B2|Baseline|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187648|NCT01423604|B1|Baseline|Ruxolitinib - Safety Run-In|Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]) + ruxolitinib at 15 mg BID.
187649|NCT01423604|P2|Participant Flow|Placebo|Part 2: Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187650|NCT01423604|P1|Participant Flow|Ruxolitinib|"Part 1: Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day (BID)) + ruxolitinib 15 mg BID.
Part 2: Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID])."
187651|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187652|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187653|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187654|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187655|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187656|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187698|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187659|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187660|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187661|NCT01423604|E3|Reported Event|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187662|NCT01423604|E2|Reported Event|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
187663|NCT01423604|E1|Reported Event|Ruxolitinib (Safety Run-In)|Subjects received capecitabine 2000 mg/m^2 daily (taken as 1000 mg/m2 twice daily [BID]) + ruxolitinib 15 mg BID
187664|NCT01423253|B1|Baseline|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
187665|NCT01423253|P1|Participant Flow|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
187666|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
187667|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
187668|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
187669|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
187670|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
187671|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
187672|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
187673|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
187674|NCT01423253|E1|Reported Event|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed
Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
187675|NCT01423162|B3|Baseline|Total|Total of all reporting groups
187676|NCT01423162|B2|Baseline|Drink Without Vit C Then Drink With Vit C|Dietary Intervention (without Vitamin C): Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
187677|NCT01423162|B1|Baseline|Drink With Vit C Then Drink Without Vit C|Dietary Intervention (with Vitamin C): Fortified oat drink with vitamin C followed by fortified oat drink without Vit C
187678|NCT01423162|P2|Participant Flow|Drink Without Vitamin C Then Drink With Vit C|Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.
187679|NCT01423162|P1|Participant Flow|Drink With Vit C Then Drink Without Vit C|Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
187680|NCT01423162|O2|Outcome|Fortified Oat Drink Without Vitamin C|
187681|NCT01423162|O1|Outcome|Fortified Oat Drink With Vitamin C|
187682|NCT01423162|E2|Reported Event|Drink Without Vitamin C Then Drink With Vit C|Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.
187683|NCT01423162|E1|Reported Event|Drink With Vit C Then Drink Without Vit C|Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
187684|NCT01423084|B3|Baseline|Total|Total of all reporting groups
187685|NCT01423084|B2|Baseline|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187686|NCT01423084|B1|Baseline|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187687|NCT01423084|P2|Participant Flow|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187688|NCT01423084|P1|Participant Flow|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187689|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187690|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187691|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187692|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187693|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187694|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187695|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187696|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187697|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187699|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187700|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187701|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187702|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187703|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187704|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187705|NCT01423084|O2|Outcome|MenB Lot 2|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187706|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187707|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187708|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187709|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187710|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187711|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187712|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187713|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187714|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187715|NCT01423084|E2|Reported Event|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
187716|NCT01423084|E1|Reported Event|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
187717|NCT01422915|B1|Baseline|Colestipol Therapy of Protoporphyria|4 subjects were assigned, all between 18-65 years of age.
187718|NCT01422915|P1|Participant Flow|Colestipol Treatment|Colestipol 2 grams twice daily for 5-6 months. Completion of sun sensitivity questionnaire and blood protoporphyrin concentrations. were obtained monthly.
187719|NCT01422915|O1|Outcome|Colestipol Treatment|Sun sensitivity and protoporphyrin levels
187720|NCT01422915|O1|Outcome|Colestipol Treatment|"gram morning and bedtime for 90 days; then
grams morning and bedtime for 90 days. Sun sensitivity questionnaires and blood protoporphyrin concns. were determined monthly."
187721|NCT01422915|E1|Reported Event|1st Period - Colestipol Optimal Dosage|"gram morning and bedtime for 90 days; then
grams morning and bedtime for 90 days. Sun sensitivity questionnaires and blood protoporphyrin concentrations were determined monthly."
187722|NCT01422889|B1|Baseline|ION Registry|The ION Registry population contains 1120 enrolled subjects with 1111 eligible for analysis. Subjects eligible for analysis includes subjects with at least one study stent implanted.
187723|NCT01422889|P1|Participant Flow|ION Registry|The ION Registry population consists of 1111 subjects that were enrolled and received a study stent.
187724|NCT01422889|O1|Outcome|ION Registry|The ION Registry includes the 1111 enrolled subjects that received a study stent.
187725|NCT01422889|O1|Outcome|ION Registry|The ION Registry includes the 1111 enrolled subjects that received a study stent.
187726|NCT01422889|E1|Reported Event|ION Registry|The ION Registry population will contain the first 1115 consecutive, consenting patients
187727|NCT01422876|B11|Baseline|Total|Total of all reporting groups
187728|NCT01422876|B10|Baseline|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187729|NCT01422876|B9|Baseline|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
187730|NCT01422876|B8|Baseline|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187731|NCT01422876|B7|Baseline|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187732|NCT01422876|B6|Baseline|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
187733|NCT01422876|B5|Baseline|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187734|NCT01422876|B4|Baseline|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
187855|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
187735|NCT01422876|B3|Baseline|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187736|NCT01422876|B2|Baseline|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187737|NCT01422876|B1|Baseline|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
187738|NCT01422876|P10|Participant Flow|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187739|NCT01422876|P9|Participant Flow|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
187740|NCT01422876|P8|Participant Flow|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187741|NCT01422876|P7|Participant Flow|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187742|NCT01422876|P6|Participant Flow|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
187743|NCT01422876|P5|Participant Flow|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187744|NCT01422876|P4|Participant Flow|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
187745|NCT01422876|P3|Participant Flow|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187746|NCT01422876|P2|Participant Flow|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187747|NCT01422876|P1|Participant Flow|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin: Oral
187748|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187749|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
187750|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187751|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187752|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
187753|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187775|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187754|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
187755|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187756|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187757|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
187758|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187759|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
187760|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187761|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187762|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
187763|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187764|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
187765|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187766|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187767|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
187768|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187769|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
187770|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187771|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187772|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
187773|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187774|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
187804|NCT01422720|B1|Baseline|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
187776|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187777|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
187778|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187779|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Ora"
187780|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187781|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187782|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
187783|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
187784|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
187785|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
187786|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
187787|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
187788|NCT01422876|E5|Reported Event|Linagliptin 5 mg|Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
187789|NCT01422876|E4|Reported Event|Empagliflozin 10 mg|Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral
187790|NCT01422876|E3|Reported Event|Empagliflozin 25 mg|Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral
187791|NCT01422876|E2|Reported Event|Empagliflozin 10 mg/Linagliptin 5 mg|Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral
187792|NCT01422876|E1|Reported Event|Empagliflozin 25 mg/Linagliptin 5 mg|Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral
187793|NCT01422850|B1|Baseline|ALECSAT|
187794|NCT01422850|P1|Participant Flow|ALECSAT|After inclusion in the ALECSAT trial, the subject donates 200 ml blood sample for the first ALECSAT product, and after 6 and 11 weeks the subject donated 200 ml again for the second and third product. ALECSAT was thereafter administered at week 4, 9, and week 14.
187795|NCT01422850|O1|Outcome|ALECSAT|
187796|NCT01422850|O1|Outcome|Trends Towards Possible Treatment Response|No significant conclusion of efficacy is possible due to the study design with only one active group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy are possible. Scintigraphy and blood tests (PSA, ALP, LDH and Creatinine)were used for this analysis.
187797|NCT01422850|O1|Outcome|ALCESAT|
187798|NCT01422850|E1|Reported Event|ALECSAT|
187799|NCT01422824|B1|Baseline|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
187800|NCT01422824|P1|Participant Flow|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
187801|NCT01422824|O1|Outcome|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
187802|NCT01422824|O1|Outcome|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
187803|NCT01422824|E1|Reported Event|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
187806|NCT01422720|O4|Outcome|PPS- Treatment Period|The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
187807|NCT01422720|O3|Outcome|PPS - Baseline Period|The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
187808|NCT01422720|O2|Outcome|FAS - Treatment Period|The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.
187809|NCT01422720|O1|Outcome|FAS - Baseline Period|The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.
187810|NCT01422720|O1|Outcome|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
187811|NCT01422720|E1|Reported Event|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
187812|NCT01422538|B4|Baseline|Total|Total of all reporting groups
187813|NCT01422538|B3|Baseline|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment. Study subjects in Group C received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).
187814|NCT01422538|B2|Baseline|Group B|Subjects received Sculptra® treatment only
187815|NCT01422538|B1|Baseline|Group A|Subjects received Ultherapy® Treatment only. Study subjects in Group A received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).
187816|NCT01422538|P3|Participant Flow|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
187817|NCT01422538|P2|Participant Flow|Group B|Subjects received Sculptra® treatment only
187818|NCT01422538|P1|Participant Flow|Group A|Subjects received Ultherapy® Treatment only.
187819|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
187820|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
187821|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
187822|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
187823|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
187824|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
187825|NCT01422538|O2|Outcome|Group C|Subjects received Sculptra® and Ultherapy® Treatment.
187826|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
187827|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
187828|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
187829|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
187830|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
187831|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
187832|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
187833|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
187834|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
187835|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
187836|NCT01422538|E3|Reported Event|Group C|Subjects received Sculptra® and Ultherapy® Treatment.
187837|NCT01422538|E2|Reported Event|Group B|Subjects received Sculptra® only.
187838|NCT01422538|E1|Reported Event|Group A|Subjects received Ultherapy® Treatment only.
187839|NCT01422434|B4|Baseline|Total|Total of all reporting groups
187840|NCT01422434|B3|Baseline|Rinderon® - DP Ointment|"Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
187841|NCT01422434|B2|Baseline|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
187842|NCT01422434|B1|Baseline|Dovonex® Ointment|"Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
187843|NCT01422434|P3|Participant Flow|Rinderon® - DP Ointment (Betamethasone Dipropionate)|"Applied once daily for 4 weeks
Rinderon® - DP ointment ( betamethasone dipropionate) : Applied once daily for 4 weeks."
187844|NCT01422434|P2|Participant Flow|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
187845|NCT01422434|P1|Participant Flow|Dovonex® Ointment|"Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
187846|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
187847|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
187848|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
187849|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
187850|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
187851|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
187852|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
187853|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
187854|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
190569|NCT01409382|O1|Outcome|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
187856|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
187857|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
187858|NCT01422434|E3|Reported Event|Rinderon® - DP Ointment|"Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
187859|NCT01422434|E2|Reported Event|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
187860|NCT01422434|E1|Reported Event|Dovonex® Ointment|"Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
187861|NCT01422408|B1|Baseline|Supportive Care|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187862|NCT01422408|P1|Participant Flow|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187863|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187864|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187865|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187866|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187867|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187868|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187869|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187870|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187871|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187872|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187873|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187874|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187875|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187876|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187877|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
188840|NCT01417455|E2|Reported Event|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
187878|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187879|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187880|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187881|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187882|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187883|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187884|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187885|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187886|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187887|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187888|NCT01422408|O1|Outcome|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187889|NCT01422408|E1|Reported Event|Supportive Care (Fluocinonide Cream)|"This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks."
187890|NCT01422382|B1|Baseline|All Subjects|All randomized subjects.
187891|NCT01422382|P1|Participant Flow|All Subjects|All randomized subjects.
187892|NCT01422382|O1|Outcome|All Subjects|All randomized subjects.
187893|NCT01422382|O1|Outcome|All Subjects|All randomized subjects.
187894|NCT01422382|E1|Reported Event|All Subjects|All randomized subjects.
187895|NCT01422369|B1|Baseline|All Subjects|All randomized subjects
187896|NCT01422369|P1|Participant Flow|All Subjects|All randomized subjects
187897|NCT01422369|O1|Outcome|All Subjects|All randomized subjects
187898|NCT01422369|O1|Outcome|NK-104|NK-104 4mg once daily (QD)
187899|NCT01422369|E1|Reported Event|All Subjects|All randomized subjects
187900|NCT01422356|B1|Baseline|12 Month Cohort|
187901|NCT01422356|P1|Participant Flow|12 Month Cohort|16-20 year old males
187902|NCT01422356|O1|Outcome|Baseline Prevalence|
187903|NCT01422356|E1|Reported Event|12 Month Cohort|
187904|NCT01422304|B3|Baseline|Total|Total of all reporting groups
187905|NCT01422304|B2|Baseline|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187906|NCT01422304|B1|Baseline|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187920|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187907|NCT01422304|P2|Participant Flow|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187908|NCT01422304|P1|Participant Flow|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187909|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187910|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187911|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187912|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187913|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187914|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187915|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187916|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187917|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187918|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187919|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
188009|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
188010|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
188011|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
188012|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187921|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187922|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187923|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187924|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187925|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187926|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187927|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187928|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187929|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187930|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187931|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187932|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187933|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
188013|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
188014|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
188015|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
188016|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187934|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187935|NCT01422304|E2|Reported Event|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
187936|NCT01422304|E1|Reported Event|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
187937|NCT01422239|B3|Baseline|Total|Total of all reporting groups
187938|NCT01422239|B2|Baseline|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
187939|NCT01422239|B1|Baseline|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
187940|NCT01422239|P2|Participant Flow|Standard Behavioral Counseling|The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's smoking cessation manual. All of the material for sessions 4-8 for the standard behavioral counseling condition will cover topics from the Mayo Clinic's smoking cessation manual - Session 4: coping with triggers to smoke and nicotine withdrawal, Session 5: Stress Management, Session 6: Time Management and Self-Image, Session 7: Communication Skills and Wellness, Session 8: Focusing on the Future (maintenance of smoking abstinence).
187941|NCT01422239|P1|Participant Flow|Tailored Behavioral Counseling|The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session, coping with withdrawal symptoms in the third session, and on coping with triggers and withdrawal in the forth session using the Mayo Clinic's smoking cessation manual. The focus of sessions 5-7 will be the three perceive risks of quitting that were not covered during the first three session (i.e., the three least highly endorsed risks). Session 8 will cover maintenance of smoking abstinence using the Mayo Clinic manual.
187942|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
187943|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
187944|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
187945|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
187946|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
187947|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
188017|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
188018|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
188019|NCT01422213|E3|Reported Event|Vortioxetine 20 mg|
187948|NCT01422239|E2|Reported Event|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
187949|NCT01422239|E1|Reported Event|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
187950|NCT01422226|B3|Baseline|Total|Total of all reporting groups
187951|NCT01422226|B2|Baseline|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
187952|NCT01422226|B1|Baseline|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
187953|NCT01422226|P2|Participant Flow|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
187954|NCT01422226|P1|Participant Flow|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
187955|NCT01422226|O2|Outcome|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
187956|NCT01422226|O1|Outcome|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
187957|NCT01422226|E2|Reported Event|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
187958|NCT01422226|E1|Reported Event|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
187959|NCT01422213|B4|Baseline|Total|Total of all reporting groups
187960|NCT01422213|B3|Baseline|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187961|NCT01422213|B2|Baseline|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187962|NCT01422213|B1|Baseline|Placebo|capsules, daily, orally
187963|NCT01422213|P3|Participant Flow|Vortioxetine 20 mg|encapsulated tablets; daily; orally
187964|NCT01422213|P2|Participant Flow|Vortioxetine 10 mg|encapsulated tablets; daily; orally
187965|NCT01422213|P1|Participant Flow|Placebo|capsules; daily; orally
187966|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187967|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187968|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187969|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187970|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187971|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187972|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187973|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187974|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187975|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187976|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187977|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187978|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187979|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187980|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187981|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187982|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187983|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187984|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187985|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187986|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187987|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187988|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187989|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187990|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187991|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187992|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187993|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187994|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187995|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187996|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
187997|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
187998|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
187999|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
188000|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
188001|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
188002|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
188003|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
188004|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
188005|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
188006|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
188007|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
188008|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
188023|NCT01422187|B3|Baseline|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188024|NCT01422187|B2|Baseline|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188025|NCT01422187|B1|Baseline|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188026|NCT01422187|P3|Participant Flow|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188027|NCT01422187|P2|Participant Flow|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188028|NCT01422187|P1|Participant Flow|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188029|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188030|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188031|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188032|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188033|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188034|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188035|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188036|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188037|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188038|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188039|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188040|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188041|NCT01422187|E3|Reported Event|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188042|NCT01422187|E2|Reported Event|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188043|NCT01422187|E1|Reported Event|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg
Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
188044|NCT01422070|B3|Baseline|Total|Total of all reporting groups
188045|NCT01422070|B2|Baseline|Units Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
188046|NCT01422070|B1|Baseline|Units With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
188047|NCT01422070|P2|Participant Flow|Units in Hospitals Without Intermediate Care Unit|Adult patients consecutively admitted to Intensive Care Units in hospitals without intermediate care unit
188048|NCT01422070|P1|Participant Flow|Units in Hospitals With Intermediate Care Unit|Adult patients consecutively admitted to Intensive Care Units in hospitals with intermediate care unit
188049|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
188050|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
188051|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
188052|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
188053|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
188054|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
188055|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
188056|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
188057|NCT01422070|E1|Reported Event|Adverse Events Not Collected|Adverse events were not collected
188058|NCT01421719|B1|Baseline|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
188059|NCT01421719|P1|Participant Flow|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
188060|NCT01421719|O1|Outcome|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
188061|NCT01421719|O1|Outcome|Urinary Leaks Per Day|3-day voiding diary produced the clinical observation as an average per evaluation milestone.
188062|NCT01421719|E1|Reported Event|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
188063|NCT01421667|B5|Baseline|Total|Total of all reporting groups
188064|NCT01421667|B4|Baseline|CD30+ DLBCL, BV+R|
188065|NCT01421667|B3|Baseline|CD30u DLBCL, BV|
188066|NCT01421667|B2|Baseline|CD30+ B-Cell NHL, BV|
188067|NCT01421667|B1|Baseline|CD30+ T-Cell NHL, BV|
188068|NCT01421667|P4|Participant Flow|CD30+ DLBCL, BV+R|Part B - Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients with CD30-positive diffuse large B-cell lymphoma (DLBCL)
188069|NCT01421667|P3|Participant Flow|CD30u DLBCL, BV|Part C - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
188070|NCT01421667|P2|Participant Flow|CD30+ B-Cell NHL, BV|Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive B-cell non-Hodgkin lymphomas (NHL), including CD30-positive diffuse large B-cell lymphoma (DLBCL) and other CD30-positive B-cell NHLs
188071|NCT01421667|P1|Participant Flow|CD30+ T-Cell NHL, BV|Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive mature T-cell non-Hodgkin lymphomas (NHL)
188072|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
188073|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
188074|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
188075|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
188076|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
188077|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
188078|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
188079|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
188080|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
188081|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
188082|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
188083|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
188084|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
188085|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
188086|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
188087|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
188088|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
188089|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
188090|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
188091|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
188092|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
188093|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
188094|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
188095|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
188096|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
188097|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
188098|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
188099|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
188100|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
188101|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
188102|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
188103|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
188104|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
188105|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
188106|NCT01421667|O5|Outcome|CD30+ DLBCL, BV+R|
188107|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
188108|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
188109|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
188110|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
188111|NCT01421667|O1|Outcome|CD30+ DLBCL, BV+R|
188112|NCT01421667|O1|Outcome|CD30+ DLBCL, BV+R|Part B - CD30-positive diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
188113|NCT01421667|O4|Outcome|CD30u DLBCL, BV|Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
188114|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
188115|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
188116|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
188117|NCT01421667|E3|Reported Event|CD30+ DLBCL, BV+R|Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients in Part B with diffuse large B-cell lymphoma (DLBCL)
188118|NCT01421667|E2|Reported Event|CD30u DLBCL, BV|Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in Part C with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
188119|NCT01421667|E1|Reported Event|CD30+ NHL (T-Cell and B-Cell), BV|Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive non-Hodgkin lymphomas (NHL), including T-cell lymphomas and B-cell lymphomas, as well as diffuse large B-cell lymphoma (DLBCL)
188120|NCT01421654|B3|Baseline|Total|Total of all reporting groups
188121|NCT01421654|B2|Baseline|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
188122|NCT01421654|B1|Baseline|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
188123|NCT01421654|P2|Participant Flow|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
188124|NCT01421654|P1|Participant Flow|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
188125|NCT01421654|O2|Outcome|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
188126|NCT01421654|O1|Outcome|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
188127|NCT01421654|E2|Reported Event|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
188128|NCT01421654|E1|Reported Event|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
188129|NCT01421641|B3|Baseline|Total|Total of all reporting groups
188130|NCT01421641|B2|Baseline|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
188841|NCT01417455|E1|Reported Event|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
188131|NCT01421641|B1|Baseline|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
188132|NCT01421641|P2|Participant Flow|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
188133|NCT01421641|P1|Participant Flow|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
188134|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
188135|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
188136|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
188137|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
188138|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
188139|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
188140|NCT01421641|E2|Reported Event|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
188141|NCT01421641|E1|Reported Event|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
188142|NCT01421589|B1|Baseline|Growth Hormone|Growth hormone treatment: Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
188143|NCT01421589|P1|Participant Flow|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
188144|NCT01421589|O1|Outcome|Growth Hormone|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
188145|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
188146|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
188147|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
188148|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
188149|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
188150|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
188151|NCT01421589|E1|Reported Event|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
188152|NCT01421511|B3|Baseline|Total|Total of all reporting groups
188153|NCT01421511|B2|Baseline|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
188154|NCT01421511|B1|Baseline|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
188155|NCT01421511|P2|Participant Flow|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
188156|NCT01421511|P1|Participant Flow|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
188157|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
188158|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
188159|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
188160|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
188161|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
188162|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
188163|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
188164|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
188165|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
188166|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
188167|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
188168|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
188169|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
188170|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
188171|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
188172|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
188173|NCT01421511|E2|Reported Event|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
188174|NCT01421511|E1|Reported Event|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
188187|NCT01421472|B4|Baseline|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:
Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
188188|NCT01421472|B3|Baseline|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:
2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
188189|NCT01421472|B2|Baseline|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:
Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
188190|NCT01421472|B1|Baseline|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:
2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
188191|NCT01421472|P4|Participant Flow|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:
Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
188192|NCT01421472|P3|Participant Flow|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:
2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
188193|NCT01421472|P2|Participant Flow|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:
Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
188194|NCT01421472|P1|Participant Flow|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:
2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
188195|NCT01421472|O4|Outcome|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:
Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
188196|NCT01421472|O3|Outcome|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:
2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
188197|NCT01421472|O2|Outcome|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:
Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
188198|NCT01421472|O1|Outcome|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:
2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
188199|NCT01421472|E4|Reported Event|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:
Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
188200|NCT01421472|E3|Reported Event|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:
2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
188201|NCT01421472|E2|Reported Event|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:
Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
188202|NCT01421472|E1|Reported Event|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:
2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
188203|NCT01421459|B3|Baseline|Total|Total of all reporting groups
188204|NCT01421459|B2|Baseline|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188205|NCT01421459|B1|Baseline|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188206|NCT01421459|P2|Participant Flow|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188207|NCT01421459|P1|Participant Flow|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188208|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188209|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188210|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188361|NCT01420848|O2|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
188211|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188212|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188213|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188214|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188215|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188216|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188217|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188218|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188219|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188220|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188221|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188222|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188223|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188224|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188225|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188226|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188227|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188228|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188229|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188230|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188231|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188232|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188233|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188234|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188235|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188236|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188237|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188238|NCT01421459|E2|Reported Event|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
188239|NCT01421459|E1|Reported Event|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
188240|NCT01421355|B1|Baseline|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.
Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
191014|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
188241|NCT01421355|P1|Participant Flow|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.
Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
188242|NCT01421355|O1|Outcome|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.
Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
188243|NCT01421355|E1|Reported Event|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.
Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
188244|NCT01421303|B1|Baseline|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188245|NCT01421303|P1|Participant Flow|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188246|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188247|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188248|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188249|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188250|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188251|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188252|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188253|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188254|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188255|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188256|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188257|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188258|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188259|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188260|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188261|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188262|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188263|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188264|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188265|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188266|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188267|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188268|NCT01421303|E1|Reported Event|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
188269|NCT01421277|B3|Baseline|Total|Total of all reporting groups
188270|NCT01421277|B2|Baseline|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
188271|NCT01421277|B1|Baseline|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
188272|NCT01421277|P2|Participant Flow|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
188273|NCT01421277|P1|Participant Flow|Participants Enrolled in Protocol Version (V)1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
188274|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
188275|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
188276|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
188277|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
188278|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
188279|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
188280|NCT01421277|E2|Reported Event|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
188281|NCT01421277|E1|Reported Event|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
188282|NCT01421147|B3|Baseline|Total|Total of all reporting groups
188283|NCT01421147|B2|Baseline|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188284|NCT01421147|B1|Baseline|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188285|NCT01421147|P2|Participant Flow|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188286|NCT01421147|P1|Participant Flow|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188287|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188892|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
188288|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188289|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188290|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188291|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188292|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188293|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188294|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188295|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188296|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188297|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188298|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188299|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188300|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188301|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188302|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188303|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188419|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188304|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188305|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188306|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188307|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188308|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188309|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188310|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188311|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188312|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188313|NCT01421147|E2|Reported Event|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188314|NCT01421147|E1|Reported Event|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
188315|NCT01421134|B3|Baseline|Total|Total of all reporting groups
188316|NCT01421134|B2|Baseline|Placebo|"Placebo
Placebo: Placebo"
188317|NCT01421134|B1|Baseline|Lurasidone|"Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
188318|NCT01421134|P2|Participant Flow|Placebo|"Placebo
Placebo: Placebo"
188319|NCT01421134|P1|Participant Flow|Lurasidone|"Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
188320|NCT01421134|O2|Outcome|Placebo|"Placebo
Placebo: Placebo"
188321|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
188322|NCT01421134|O2|Outcome|Placebo|"Placebo
Placebo: Placebo"
188323|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
188324|NCT01421134|O2|Outcome|Placebo|"Placebo
Placebo: Placebo"
188325|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
188326|NCT01421134|O2|Outcome|Placebo|"Placebo
Placebo: Placebo"
188327|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
188328|NCT01421134|O2|Outcome|Placebo|"Placebo
Placebo: Placebo"
188329|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
188330|NCT01421134|O2|Outcome|Placebo|"Placebo
Placebo: Placebo"
188331|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
188332|NCT01421134|O2|Outcome|Placebo|"Placebo
Placebo: Placebo"
188333|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
188334|NCT01421134|E2|Reported Event|Placebo|"Placebo
Placebo: Placebo"
188335|NCT01421134|E1|Reported Event|Lurasidone|"Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
188336|NCT01420926|B3|Baseline|Total|Total of all reporting groups
188337|NCT01420926|B2|Baseline|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188338|NCT01420926|B1|Baseline|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188339|NCT01420926|P2|Participant Flow|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188340|NCT01420926|P1|Participant Flow|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188341|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188342|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188343|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188344|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188345|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188420|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188346|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188347|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188348|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188349|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188350|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188351|NCT01420926|E2|Reported Event|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188352|NCT01420926|E1|Reported Event|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
188353|NCT01420848|B4|Baseline|Total|Total of all reporting groups
188354|NCT01420848|B3|Baseline|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
188355|NCT01420848|B2|Baseline|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
188356|NCT01420848|B1|Baseline|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.
Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).
Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
188357|NCT01420848|P3|Participant Flow|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
188358|NCT01420848|P2|Participant Flow|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
188359|NCT01420848|P1|Participant Flow|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.
Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).
Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
188360|NCT01420848|O3|Outcome|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
191068|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
188362|NCT01420848|O1|Outcome|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.
Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).
Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
188363|NCT01420848|O3|Outcome|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
188364|NCT01420848|O2|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
188365|NCT01420848|O1|Outcome|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.
Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).
Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
188366|NCT01420848|E3|Reported Event|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
188367|NCT01420848|E2|Reported Event|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
188368|NCT01420848|E1|Reported Event|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.
Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).
Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
188369|NCT01420289|B3|Baseline|Total|Total of all reporting groups
188370|NCT01420289|B2|Baseline|Excercise|Walking on a graded treadmill for 45 minutes once daily
188371|NCT01420289|B1|Baseline|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
188372|NCT01420289|P2|Participant Flow|Excercise|Walking on a graded treadmill for 45 minutes once daily
188373|NCT01420289|P1|Participant Flow|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
188374|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
188375|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
188376|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
188377|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
188378|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
188379|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
188380|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
188381|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
188382|NCT01420289|E2|Reported Event|Excercise|Walking on a graded treadmill for 45 minutes once daily
188383|NCT01420289|E1|Reported Event|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
188384|NCT01420146|B1|Baseline|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
188385|NCT01420146|P1|Participant Flow|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
188386|NCT01420146|O1|Outcome|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
188387|NCT01420146|E1|Reported Event|Zr89-trastuzumab PET/CT|"Zr89-trastuzumab PET/CT single arm
Zr89-trastuzumab: trastuzumab labelled with zirconium 89 for PET/CT"
188388|NCT01420081|B10|Baseline|Total|Total of all reporting groups
188389|NCT01420081|B9|Baseline|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188390|NCT01420081|B8|Baseline|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188391|NCT01420081|B7|Baseline|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188392|NCT01420081|B6|Baseline|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188393|NCT01420081|B5|Baseline|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188394|NCT01420081|B4|Baseline|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188395|NCT01420081|B3|Baseline|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
192025|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
188396|NCT01420081|B2|Baseline|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188397|NCT01420081|B1|Baseline|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
188398|NCT01420081|P9|Participant Flow|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188399|NCT01420081|P8|Participant Flow|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188400|NCT01420081|P7|Participant Flow|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188401|NCT01420081|P6|Participant Flow|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188402|NCT01420081|P5|Participant Flow|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, once weekly (Quaque, QW) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188403|NCT01420081|P4|Participant Flow|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188404|NCT01420081|P3|Participant Flow|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
188405|NCT01420081|P2|Participant Flow|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188406|NCT01420081|P1|Participant Flow|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, once daily (QD) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
188407|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188408|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188409|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188410|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188411|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188412|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188413|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188414|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188415|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188416|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188417|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188418|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188893|NCT01417078|O2|Outcome|Nordiazepam|Diazepam was slowly converted to nordiazepam following intranasal administration
188421|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188422|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188423|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188424|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188425|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188426|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188427|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188428|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188429|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188430|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188431|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188432|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188433|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188434|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188435|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188436|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188437|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188438|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188439|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188440|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188441|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188442|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188443|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188444|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188445|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188446|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188447|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188448|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188537|NCT01419639|B1|Baseline|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
188449|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188450|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188451|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188452|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188453|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188454|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188455|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188456|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188457|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188458|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188459|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188460|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188461|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188462|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188463|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188464|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188465|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188466|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188467|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188468|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188469|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188470|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188471|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188472|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
188473|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188474|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188538|NCT01419639|P1|Participant Flow|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
192026|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
188475|NCT01420081|E9|Reported Event|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188476|NCT01420081|E8|Reported Event|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188477|NCT01420081|E7|Reported Event|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188478|NCT01420081|E6|Reported Event|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188479|NCT01420081|E5|Reported Event|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW (Quaque [Once Weekly]) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188480|NCT01420081|E4|Reported Event|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188481|NCT01420081|E3|Reported Event|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
188482|NCT01420081|E2|Reported Event|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
188483|NCT01420081|E1|Reported Event|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
188484|NCT01419977|B3|Baseline|Total|Total of all reporting groups
188485|NCT01419977|B2|Baseline|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
188486|NCT01419977|B1|Baseline|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
188487|NCT01419977|P2|Participant Flow|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
188488|NCT01419977|P1|Participant Flow|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
188489|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
188490|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
188491|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
188492|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
188493|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
188494|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
188495|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
188496|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
188497|NCT01419977|E2|Reported Event|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
188498|NCT01419977|E1|Reported Event|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
188499|NCT01419795|B3|Baseline|Total|Total of all reporting groups
188500|NCT01419795|B2|Baseline|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188501|NCT01419795|B1|Baseline|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188502|NCT01419795|P2|Participant Flow|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
192027|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
188503|NCT01419795|P1|Participant Flow|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188504|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188505|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188506|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188507|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188508|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188509|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188510|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188511|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188512|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188513|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188514|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188515|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188516|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
192028|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
188517|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188518|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188519|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188520|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188521|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188522|NCT01419795|E2|Reported Event|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
lenalidomide: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188523|NCT01419795|E1|Reported Event|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
lenalidomide: Given PO
rituximab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
188524|NCT01419769|B1|Baseline|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188525|NCT01419769|P1|Participant Flow|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188526|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188527|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188539|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
188540|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
192029|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
188528|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188529|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188530|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188531|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188532|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188533|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188534|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188535|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
188536|NCT01419769|E1|Reported Event|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
192030|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
188541|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
188542|NCT01419639|E1|Reported Event|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
188543|NCT01419314|B3|Baseline|Total|Total of all reporting groups
188544|NCT01419314|B2|Baseline|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
188545|NCT01419314|B1|Baseline|LE Splints Group|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
188546|NCT01419314|P2|Participant Flow|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
188547|NCT01419314|P1|Participant Flow|Splinting Application|Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
188548|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
188549|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
188550|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
188551|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
188552|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study.
188553|NCT01419314|O1|Outcome|Splinting Application|Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
188554|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
188555|NCT01419314|O1|Outcome|Splinting Application|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
188556|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
188557|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
188558|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
188559|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
188560|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
188561|NCT01419314|O1|Outcome|Splinting Application|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
188562|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
188563|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
188564|NCT01419314|E2|Reported Event|Splint Liner|Night time application of lower extremity splint liner
188565|NCT01419314|E1|Reported Event|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
188566|NCT01419275|B1|Baseline|Moyamoya|Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
188567|NCT01419275|P1|Participant Flow|Moyamoya|Participants with Moyamoya disease received arterial spin label magnetic resonance imaging (MRI) with xenon contrast agent.
188568|NCT01419275|O1|Outcome|Moyamoya|Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
188569|NCT01419275|E1|Reported Event|Moyamoya|Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
188570|NCT01419249|B3|Baseline|Total|Total of all reporting groups
188571|NCT01419249|B2|Baseline|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188572|NCT01419249|B1|Baseline|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188573|NCT01419249|P2|Participant Flow|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188574|NCT01419249|P1|Participant Flow|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188575|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188576|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188716|NCT01418365|E1|Reported Event|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
188577|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188578|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188579|NCT01419249|O1|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188580|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188581|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188582|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188583|NCT01419249|E2|Reported Event|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188584|NCT01419249|E1|Reported Event|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
188585|NCT01419236|B3|Baseline|Total|Total of all reporting groups
188586|NCT01419236|B2|Baseline|Placebo|Placebo solution applied topically once daily for 16 weeks.
188587|NCT01419236|B1|Baseline|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
188588|NCT01419236|P2|Participant Flow|Placebo|Placebo solution applied topically once daily for 16 weeks.
188589|NCT01419236|P1|Participant Flow|Testosterone Solution 2%|Testosterone solution 2% [60 milligrams (mg) applied topically once daily with a potential 1-time titration to 30 milligrams per day (mg/day) or 90 mg/day] for 16 weeks.
188590|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
188591|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
188592|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
188593|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
188594|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
188595|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
188596|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
188597|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
188598|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
188599|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
188600|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
188601|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
188602|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
188603|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
188604|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
188605|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
188606|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
188607|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
188608|NCT01419236|E2|Reported Event|Placebo|Placebo solution applied topically once daily for 16 weeks.
188609|NCT01419236|E1|Reported Event|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
188610|NCT01419197|B3|Baseline|Total|Total of all reporting groups
188717|NCT01418209|B4|Baseline|Total|Total of all reporting groups
188718|NCT01418209|B3|Baseline|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
188611|NCT01419197|B2|Baseline|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
188612|NCT01419197|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188613|NCT01419197|P2|Participant Flow|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and human epidermal growth factor receptor 2 (HER2)-directed therapy.
188614|NCT01419197|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188615|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
188616|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188617|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
188618|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188619|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
188620|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188621|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
188622|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188623|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
188624|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188625|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
188626|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188627|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
188628|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188629|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
188630|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188631|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
188632|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188633|NCT01419197|E3|Reported Event|Trastuzumab Emtansine - Post TPC Treatment Switch|Participants, who switched treatment in the Treatment of Physician's Choice arm to trastuzumab emtansine, were administered trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188634|NCT01419197|E2|Reported Event|Treatment of Physician’s Choice (TPC)|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
188635|NCT01419197|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
188636|NCT01419184|B3|Baseline|Total|Total of all reporting groups
188780|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
188637|NCT01419184|B2|Baseline|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188638|NCT01419184|B1|Baseline|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188639|NCT01419184|P2|Participant Flow|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed per investigator’s discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion.
188640|NCT01419184|P1|Participant Flow|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188641|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188642|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188643|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188644|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188645|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188646|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188647|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188648|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188649|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188650|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188651|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188652|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188653|NCT01419184|E2|Reported Event|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188654|NCT01419184|E1|Reported Event|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
188655|NCT01419171|B1|Baseline|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188656|NCT01419171|P1|Participant Flow|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188657|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188658|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188659|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
192031|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
188660|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188661|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188662|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188663|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188664|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188665|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188666|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188667|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188668|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188669|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188670|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188671|NCT01419171|E1|Reported Event|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
188672|NCT01419028|B1|Baseline|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
188673|NCT01419028|P1|Participant Flow|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
188674|NCT01419028|O1|Outcome|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
188675|NCT01419028|O1|Outcome|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
188676|NCT01419028|E1|Reported Event|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
188677|NCT01418937|B1|Baseline|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
188678|NCT01418937|P1|Participant Flow|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
188679|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
188680|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
188681|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
188682|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
188683|NCT01418937|E1|Reported Event|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
188684|NCT01418703|B3|Baseline|Total|Total of all reporting groups
188685|NCT01418703|B2|Baseline|Enhanced Control to Range (eCTR)|The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual’s conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR.
188686|NCT01418703|B1|Baseline|Standard Control to Range (sCTR)|The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour.
188781|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
188782|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
188687|NCT01418703|P4|Participant Flow|eCTR Closed-Loop First, Then Open-Loop|"Participants completed open-loop admission, then completed eCTR closed-loop admission.
The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR."
188688|NCT01418703|P3|Participant Flow|Open-Loop First, Then eCTR Closed-Loop|"Participants completed open-loop admission, then completed eCTR (Enhanced Control to Range) closed-loop admission.
The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC (model predictive control) algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the clinical research center (CRC) kitchen but automatically calculated by eCTR."
188689|NCT01418703|P2|Participant Flow|sCTR Closed-Loop First, Then Open-Loop|"Participants completed sCTR Closed-Loop admission, then completed open-loop admission.
The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour."
188690|NCT01418703|P1|Participant Flow|Open-Loop First, Then sCTR Closed-Loop|"Completed open-loop, then sCTR (Standard Control to Range ) Closed-Loop admission.
The two modules of sCTR are the SSM (safety supervision module) and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM (continuous glucose monitor) and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g. body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII (continuous subcutaneous insulin infusion) parameters."
188691|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:
monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
188692|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.
Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
188693|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:
monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
188694|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.
Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
188783|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
188784|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
188785|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
188786|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
188695|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:
monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
188696|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.
Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
188697|NCT01418703|E3|Reported Event|eCTR Closed-Loop Control|The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR.
188698|NCT01418703|E2|Reported Event|sCTR Closed-Loop Control|The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour.
188699|NCT01418703|E1|Reported Event|Open-Loop|This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).
188700|NCT01418482|B1|Baseline|Mepilex Border Ag|Mepilex Border Ag, ( a silver dressing)
188701|NCT01418482|P1|Participant Flow|Mepilex Border Ag|Mepilex Border Ag, a silver dressing
188702|NCT01418482|O1|Outcome|Mepilex Border Ag|Mepilex Border Ag
188703|NCT01418482|O1|Outcome|Mepilex Border Ag|Mepilex Border Ag
188704|NCT01418482|O1|Outcome|Mepilex Border Ag|Mepilex Border Ag
188705|NCT01418482|E1|Reported Event|Mepilex Border Ag|Mepilex Border Ag
188706|NCT01418365|B3|Baseline|Total|Total of all reporting groups
188707|NCT01418365|B2|Baseline|Metronidazole + MMX Mesalazine/Mesalamine First|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
188708|NCT01418365|B1|Baseline|Metronidazole + MMX Placebo First|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
188709|NCT01418365|P2|Participant Flow|Metronidazole + MMX Mesalazine/Mesalamine First|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
188710|NCT01418365|P1|Participant Flow|Metronidazole + MMX Placebo First|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
188711|NCT01418365|O2|Outcome|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
188712|NCT01418365|O1|Outcome|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
188713|NCT01418365|O2|Outcome|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
188714|NCT01418365|O1|Outcome|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
188715|NCT01418365|E2|Reported Event|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
188787|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
188719|NCT01418209|B2|Baseline|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
188720|NCT01418209|B1|Baseline|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
188721|NCT01418209|P3|Participant Flow|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
188722|NCT01418209|P2|Participant Flow|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
188723|NCT01418209|P1|Participant Flow|Low-dose 17-ß-Estradiol With Progesterone Taper|Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably. The 8 week estradiol treatment is followed 14 days (2 weeks) of progesterone taper (as medroxy-progesterone 10 mg/day).
188724|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
188725|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
188726|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
188727|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
188728|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
188729|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
188730|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
188731|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
188732|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
188733|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
188788|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
188789|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
188734|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
188735|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
188736|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
188737|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
188738|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
188739|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
188740|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
188741|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
188742|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
188743|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
188744|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
188745|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
188746|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
188747|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
188748|NCT01418209|E3|Reported Event|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
188790|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
188791|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
188749|NCT01418209|E2|Reported Event|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
188750|NCT01418209|E1|Reported Event|Low-dose 17-ß-estradiol|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
188751|NCT01418001|B1|Baseline|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
188752|NCT01418001|P1|Participant Flow|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
188753|NCT01418001|O1|Outcome|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
188754|NCT01418001|E1|Reported Event|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
188755|NCT01417936|B1|Baseline|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188756|NCT01417936|P1|Participant Flow|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188757|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188758|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188759|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188760|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188761|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188762|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188763|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188764|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188765|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188766|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188767|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188768|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188769|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188770|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188771|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188772|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188773|NCT01417936|E1|Reported Event|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
188774|NCT01417481|B3|Baseline|Total|Total of all reporting groups
188775|NCT01417481|B2|Baseline|Placebo, Then Glycine|"First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).
Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses)."
188776|NCT01417481|B1|Baseline|Glycine, Then Placebo|"First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).
Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses)."
188777|NCT01417481|P2|Participant Flow|Placebo, Then Glycine|"First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).
Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses)."
188778|NCT01417481|P1|Participant Flow|Glycine, Then Placebo|"First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).
Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses)."
188779|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
192032|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
188792|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
188793|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
188794|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
188795|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
188796|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
188797|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
188798|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
188799|NCT01417481|E2|Reported Event|Placebo|Patients received a daily oral supplement of sugar glass at a dose of 0.5 g/kg divided in three doses during 8 weeks, dissolved in any liquid.
188800|NCT01417481|E1|Reported Event|Glycine|Patients received a daily oral supplement of glycine at a dose of 0.5 g/kg divided in three doses during 8 weeks, dissolved in any liquid.
188801|NCT01417455|B9|Baseline|Total|Total of all reporting groups
188802|NCT01417455|B8|Baseline|Controls|Healthy donors age and sex matched to the patients
188803|NCT01417455|B7|Baseline|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
188804|NCT01417455|B6|Baseline|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
188805|NCT01417455|B5|Baseline|Ankylosing Spondylitis|Active Ankylosing Spondylitis
188806|NCT01417455|B4|Baseline|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
188807|NCT01417455|B3|Baseline|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
188808|NCT01417455|B2|Baseline|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
188809|NCT01417455|B1|Baseline|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
188810|NCT01417455|P8|Participant Flow|Controls|Healthy donors age and sex matched to the patients
188811|NCT01417455|P7|Participant Flow|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
188812|NCT01417455|P6|Participant Flow|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
188813|NCT01417455|P5|Participant Flow|Ankylosing Spondylitis|Active Ankylosing Spondylitis
188814|NCT01417455|P4|Participant Flow|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
188815|NCT01417455|P3|Participant Flow|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
188816|NCT01417455|P2|Participant Flow|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
188817|NCT01417455|P1|Participant Flow|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
188818|NCT01417455|O8|Outcome|Controls|Healthy donors age and sex matched to the patients
188819|NCT01417455|O7|Outcome|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
188820|NCT01417455|O6|Outcome|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
188821|NCT01417455|O5|Outcome|Ankylosing Spondylitis|Active Ankylosing Spondylitis
188822|NCT01417455|O4|Outcome|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
188823|NCT01417455|O3|Outcome|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
188824|NCT01417455|O2|Outcome|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
188825|NCT01417455|O1|Outcome|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
188826|NCT01417455|O8|Outcome|Controls|Healthy donors age and sex matched to the patients
188827|NCT01417455|O7|Outcome|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
188828|NCT01417455|O6|Outcome|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
188829|NCT01417455|O5|Outcome|Ankylosing Spondylitis|Active Ankylosing Spondylitis
188830|NCT01417455|O4|Outcome|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
188831|NCT01417455|O3|Outcome|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
188832|NCT01417455|O2|Outcome|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
188833|NCT01417455|O1|Outcome|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
188834|NCT01417455|E8|Reported Event|Controls|Healthy donors age and sex matched to the patients - Healthy donors were not under any therapy therefore they were not at risk and Adverse effects were not assessed.
188835|NCT01417455|E7|Reported Event|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
188836|NCT01417455|E6|Reported Event|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
188837|NCT01417455|E5|Reported Event|Ankylosing Spondylitis|Active Ankylosing Spondylitis
188838|NCT01417455|E4|Reported Event|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
188839|NCT01417455|E3|Reported Event|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
188842|NCT01417377|B1|Baseline|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
188843|NCT01417377|P1|Participant Flow|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
188844|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
188845|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
188846|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
188847|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
188848|NCT01417377|E1|Reported Event|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
188849|NCT01417195|B3|Baseline|Total|Total of all reporting groups
188850|NCT01417195|B2|Baseline|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
188851|NCT01417195|B1|Baseline|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
188852|NCT01417195|P2|Participant Flow|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
188853|NCT01417195|P1|Participant Flow|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
188854|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
188855|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
188856|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
188857|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
188858|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
188859|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
188860|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
188861|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
188862|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
192033|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
188863|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
188864|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
188865|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
188866|NCT01417195|E2|Reported Event|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
188867|NCT01417195|E1|Reported Event|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
188868|NCT01417156|B1|Baseline|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
188869|NCT01417156|P1|Participant Flow|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
188870|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
188871|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
188872|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
188873|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
188874|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
188875|NCT01417156|E1|Reported Event|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
188876|NCT01417104|B3|Baseline|Total|Total of all reporting groups
188877|NCT01417104|B2|Baseline|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
188878|NCT01417104|B1|Baseline|Aliskiren|Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
188879|NCT01417104|P2|Participant Flow|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
188880|NCT01417104|P1|Participant Flow|Aliskiren|Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
188881|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
188882|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
188883|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
188884|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
188885|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
188886|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
188887|NCT01417104|E2|Reported Event|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
188888|NCT01417104|E1|Reported Event|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
188889|NCT01417078|B1|Baseline|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
188890|NCT01417078|P1|Participant Flow|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
188891|NCT01417078|O2|Outcome|Nordiazepam|Diazepam was slowly converted to nordiazepam following intranasal administration.
188894|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
188895|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
188896|NCT01417078|O2|Outcome|Nordiazepam|Diazepam was slowly converted to nordiazepam following intranasal administration
188897|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
188898|NCT01417078|E1|Reported Event|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
188899|NCT01417026|B3|Baseline|Total|Total of all reporting groups
188900|NCT01417026|B2|Baseline|Intranasal Placebo|"Intranasal placebo
The placebo is identical to the oxytocin formulation with the exception of the active compound.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.
One dose equals 6 spray puffs (3 puffs in each nostril).
Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188901|NCT01417026|B1|Baseline|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)
Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.
One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).
Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188902|NCT01417026|P2|Participant Flow|Intranasal Placebo|"Intranasal placebo
The placebo is identical to the oxytocin formulation with the exception of the active compound.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.
One dose equals 6 spray puffs (3 puffs in each nostril).
Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188903|NCT01417026|P1|Participant Flow|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)
Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.
One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).
Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188904|NCT01417026|O2|Outcome|Intranasal Placebo|"Intranasal placebo
The placebo is identical to the oxytocin formulation with the exception of the active compound.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.
One dose equals 6 spray puffs (3 puffs in each nostril).
Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188905|NCT01417026|O1|Outcome|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)
Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.
One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).
Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188906|NCT01417026|O2|Outcome|Intranasal Placebo|"Intranasal placebo
The placebo is identical to the oxytocin formulation with the exception of the active compound.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.
One dose equals 6 spray puffs (3 puffs in each nostril).
Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188929|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
189294|NCT01414413|P1|Participant Flow|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
188907|NCT01417026|O1|Outcome|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)
Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.
One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).
Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188908|NCT01417026|O2|Outcome|Intranasal Placebo|"Intranasal placebo
The placebo is identical to the oxytocin formulation with the exception of the active compound.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.
One dose equals 6 spray puffs (3 puffs in each nostril).
Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188909|NCT01417026|O1|Outcome|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)
Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.
One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).
Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188910|NCT01417026|E2|Reported Event|Intranasal Placebo|"Intranasal placebo
The placebo is identical to the oxytocin formulation with the exception of the active compound.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.
One dose equals 6 spray puffs (3 puffs in each nostril).
Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188911|NCT01417026|E1|Reported Event|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)
Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.
Route of administration: Intranasal
Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.
One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).
Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
188912|NCT01416610|B1|Baseline|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
188913|NCT01416610|P1|Participant Flow|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
188914|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
188915|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
188916|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
188917|NCT01416610|O4|Outcome|End of Follow-up|End of Follow-up Visit
188918|NCT01416610|O3|Outcome|End of Treatment|End of Treatment Visit
188919|NCT01416610|O2|Outcome|Week 12|Week 12 Visit
188920|NCT01416610|O1|Outcome|Baseline|Baseline Visit
188921|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
188922|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
188923|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
188924|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
188925|NCT01416610|E1|Reported Event|Safety Population|Participants who started treatment
188926|NCT01416571|B1|Baseline|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188927|NCT01416571|P1|Participant Flow|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188928|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188930|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188931|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188932|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188933|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188934|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188935|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188936|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188937|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188938|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188939|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188940|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188941|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188942|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188943|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188944|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188945|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188946|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188947|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188948|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188949|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188950|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188951|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188952|NCT01416571|E1|Reported Event|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
188953|NCT01416272|B1|Baseline|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care
KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
188954|NCT01416272|P1|Participant Flow|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care
KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
188955|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care
KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
188956|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care
KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
188957|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care
KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
188958|NCT01416272|E1|Reported Event|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care
KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
188959|NCT01416181|B3|Baseline|Total|Total of all reporting groups
188960|NCT01416181|B2|Baseline|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188961|NCT01416181|B1|Baseline|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188962|NCT01416181|P2|Participant Flow|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188963|NCT01416181|P1|Participant Flow|Placebo|Part 1: participants were randomized to receive placebo intravenously (IV) every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188964|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188965|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188966|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188967|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188968|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188969|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188970|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188971|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188972|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188973|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188974|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188975|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188976|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188977|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188978|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188979|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188980|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188981|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188982|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188983|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188984|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188985|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188986|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188987|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188988|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188989|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188990|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188991|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188992|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188993|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188994|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188995|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188996|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188997|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188998|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
188999|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189000|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189001|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189002|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189003|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189004|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189005|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189006|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189007|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189008|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189009|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189010|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
192034|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
189011|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189012|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189013|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189014|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189015|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189016|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189017|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189018|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189019|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189020|NCT01416181|O2|Outcome|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189021|NCT01416181|O1|Outcome|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189022|NCT01416181|E2|Reported Event|Natalizumab 300 mg|Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189023|NCT01416181|E1|Reported Event|Placebo|Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
189024|NCT01416155|B1|Baseline|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
189025|NCT01416155|P1|Participant Flow|Natalizumab|300 mg intravenous (IV) infusions of natalizumab open label every 4 weeks
189026|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
189027|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
189028|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
189029|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
189030|NCT01416155|E1|Reported Event|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
189031|NCT01416142|B1|Baseline|All Eligible Baseline Participants|Participants crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.
189032|NCT01416142|P3|Participant Flow|PureVision2 HD|Following the movie participants wore PureVision2 HD lenses on a daily wear basis for one week.
189033|NCT01416142|P2|Participant Flow|Spectacles:PureVision2 HD|Participants crossed over from spectacle wear to PureVision2 HD contact lenses during the movie intermission.
189034|NCT01416142|P1|Participant Flow|PureVision2 HD:Spectacles|Participants:crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission.
189035|NCT01416142|O3|Outcome|No Difference|Participants reporting no difference between the PureVision2 HD lens and spectacles
189036|NCT01416142|O2|Outcome|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
189037|NCT01416142|O1|Outcome|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses.
189038|NCT01416142|O2|Outcome|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
189039|NCT01416142|O1|Outcome|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses. The lower the mean logMAR the better the VA.
189040|NCT01416142|E2|Reported Event|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
189041|NCT01416142|E1|Reported Event|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses.
189042|NCT01416129|B3|Baseline|Total|Total of all reporting groups
189043|NCT01416129|B2|Baseline|Active Comparator: Prosthetic Brimless Socket|This is the experimental socket condition that includes lower trimlines, below the level of the ischial tuberosity.
189044|NCT01416129|B1|Baseline|Active Comparator: Prosthetic Socket Standard of Care|This socket is the standard of care and is defined by higher trimlines and a medial wall that contains the ischial tuberosity.
189045|NCT01416129|P2|Participant Flow|Prosthetic Socket (Experimental): Brimless Socket|5 subjects randomized to the experimental condition then, following assessment, crossed over to accommodate and re-test with the standard of care (ischial containment socket).
189106|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189046|NCT01416129|P1|Participant Flow|Standard of Care Prosthetic Socket (Ischial Containment)|In this crossover study, 5 subjects were randomized to continue using their ischial containment socket socket first. After assessment, subjects crossed over into the other condition.
189047|NCT01416129|O2|Outcome|Active Comparator/Experimental: Prosthetic Brimless Socket|
189048|NCT01416129|O1|Outcome|Control Condition: Prosthetic Socket Standard of Care|
189049|NCT01416129|E2|Reported Event|Standard of Care Socket|
189050|NCT01416129|E1|Reported Event|Vacuum Assisted Socket|
189051|NCT01416025|B3|Baseline|Total|Total of all reporting groups
189052|NCT01416025|B2|Baseline|Standard Dosing|Standard doses of voriconazole will be used
189053|NCT01416025|B1|Baseline|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels
Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
189054|NCT01416025|P2|Participant Flow|Standard Dosing|Standard doses of voriconazole will be used
189055|NCT01416025|P1|Participant Flow|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels
Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
189056|NCT01416025|O2|Outcome|Standard Dosing|Standard doses of voriconazole will be used
189057|NCT01416025|O1|Outcome|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels
Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
189058|NCT01416025|E2|Reported Event|Standard Dosing|Standard doses of voriconazole will be used
189059|NCT01416025|E1|Reported Event|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels
Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
189060|NCT01415986|B1|Baseline|Group 1|Interstitial Photodynamic Therapy (I-PDT)
189061|NCT01415986|P1|Participant Flow|Group 1|Interstitial Photodynamic Therapy (I-PDT). This subject was adminatred with 0.15 mg/kg Foscan on day 1. He was trtaed with I-PDT using 652-nm light at 20 J/cm, 4 days after the drug adminstration. He stayed in a outpatient facility for 3 more days and discharged home.
189062|NCT01415986|O1|Outcome|Group 1|Interstitial Photodynamic Therapy (I-PDT)
189063|NCT01415986|O1|Outcome|Group 1|Interstitial Photodynamic Therapy (PDT)
189064|NCT01415986|E1|Reported Event|Group 1|Interstitial Photodynamic Therapy (I-PDT)
189065|NCT01415960|B1|Baseline|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart
Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
189066|NCT01415960|P1|Participant Flow|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart
Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
189067|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.
Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
189068|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.
Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
189069|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.
Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
189070|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.
Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
189071|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.
Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
189072|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.
Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
189073|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.
Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
189074|NCT01415960|E1|Reported Event|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart
Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
189075|NCT01415921|B3|Baseline|Total|Total of all reporting groups
189076|NCT01415921|B2|Baseline|Placebo|"Matching placebo forced titration 15-60 mg as tolerated
Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
189077|NCT01415921|B1|Baseline|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated
Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
189078|NCT01415921|P2|Participant Flow|Placebo|"Matching placebo forced titration 15-60 mg as tolerated
Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
189079|NCT01415921|P1|Participant Flow|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated
Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
189213|NCT01415427|O5|Outcome|Total|All treatment groups
189080|NCT01415921|O2|Outcome|Placebo|"Matching placebo forced titration 15-60 mg as tolerated
Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
189081|NCT01415921|O1|Outcome|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated
Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
189082|NCT01415921|O2|Outcome|Placebo|"Matching placebo forced titration 15-60 mg as tolerated
Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
189083|NCT01415921|O1|Outcome|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated
Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
189084|NCT01415921|E2|Reported Event|Placebo|"Matching placebo forced titration 15-60 mg as tolerated
Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
189085|NCT01415921|E1|Reported Event|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated
Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
189086|NCT01415908|B3|Baseline|Total|Total of all reporting groups
189087|NCT01415908|B2|Baseline|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189088|NCT01415908|B1|Baseline|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189089|NCT01415908|P2|Participant Flow|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189090|NCT01415908|P1|Participant Flow|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189091|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189092|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189093|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189094|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189095|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189096|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189097|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189098|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189099|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189100|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189101|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189102|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189103|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189104|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189105|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189295|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
189107|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189108|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189109|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189110|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189111|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189112|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189113|NCT01415908|E2|Reported Event|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
189114|NCT01415908|E1|Reported Event|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
189115|NCT01415583|B3|Baseline|Total|Total of all reporting groups
189116|NCT01415583|B2|Baseline|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
189117|NCT01415583|B1|Baseline|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
189118|NCT01415583|P2|Participant Flow|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
189119|NCT01415583|P1|Participant Flow|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
189120|NCT01415583|O2|Outcome|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
189121|NCT01415583|O1|Outcome|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
189122|NCT01415583|E2|Reported Event|Dexamethasone|Dexamethasone: 0.5mg/kg (max dose 20mg)
189123|NCT01415583|E1|Reported Event|Saline|Dexamethasone: 0.5mg/kg (max dose 20mg)
189124|NCT01415531|B3|Baseline|Total|Total of all reporting groups
189125|NCT01415531|B2|Baseline|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
189126|NCT01415531|B1|Baseline|Placebo|Dose-matched placebo
189127|NCT01415531|P2|Participant Flow|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
189128|NCT01415531|P1|Participant Flow|Placebo|Dose-matched placebo
189129|NCT01415531|O2|Outcome|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
189130|NCT01415531|O1|Outcome|Placebo|Dose-matched placebo
189131|NCT01415531|O2|Outcome|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
189132|NCT01415531|O1|Outcome|Placebo|Dose-matched placebo
189133|NCT01415531|E2|Reported Event|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
189134|NCT01415531|E1|Reported Event|Placebo|Dose-matched placebo
189135|NCT01415518|B3|Baseline|Total|Total of all reporting groups
189136|NCT01415518|B2|Baseline|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189137|NCT01415518|B1|Baseline|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189138|NCT01415518|P2|Participant Flow|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189139|NCT01415518|P1|Participant Flow|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189140|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189141|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189142|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189143|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189144|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189145|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189146|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189147|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189148|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189149|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189150|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189151|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189152|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189153|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189154|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189155|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189156|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189157|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189158|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189159|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189160|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189161|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189162|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189163|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189164|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189165|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189166|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189167|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189168|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189169|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189170|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189171|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189172|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189173|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189174|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189175|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189176|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189214|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189177|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189178|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189179|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189180|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189181|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189182|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189183|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189184|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189185|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189186|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189187|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189188|NCT01415518|E2|Reported Event|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189189|NCT01415518|E1|Reported Event|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
189190|NCT01415453|B1|Baseline|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
189191|NCT01415453|P1|Participant Flow|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
189192|NCT01415453|O1|Outcome|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
189193|NCT01415453|E1|Reported Event|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
189194|NCT01415427|B5|Baseline|Total|Total of all reporting groups
189195|NCT01415427|B4|Baseline|QW-QW|BMN110 2.0 mg/kg/qw in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
189196|NCT01415427|B3|Baseline|QOW-QOW|BMN110 2.0 mg/kg/qow in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
189197|NCT01415427|B2|Baseline|PBO-QW|Placebo in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
189198|NCT01415427|B1|Baseline|PBO-QOW|Placebo in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
189199|NCT01415427|P4|Participant Flow|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189200|NCT01415427|P3|Participant Flow|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189201|NCT01415427|P2|Participant Flow|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189202|NCT01415427|P1|Participant Flow|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189203|NCT01415427|O5|Outcome|Total|All treatment groups
189204|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189205|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189206|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189207|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189208|NCT01415427|O5|Outcome|Total|All treatment groups
189209|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189210|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189211|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189212|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189215|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189216|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189217|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189218|NCT01415427|O5|Outcome|Total|All treatment groups
189219|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189220|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189221|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189222|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189223|NCT01415427|O5|Outcome|Total|All treatment groups
189224|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189225|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189226|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189227|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189228|NCT01415427|O5|Outcome|Total|All treatment groups
189229|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189230|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189231|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
189232|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
189233|NCT01415427|E5|Reported Event|Total|Total
189234|NCT01415427|E4|Reported Event|QW-QW|QW-QW
189235|NCT01415427|E3|Reported Event|QOW-QOW|QOW-QOW
189236|NCT01415427|E2|Reported Event|PBO-QW|PBO-QW
189237|NCT01415427|E1|Reported Event|PBO-QOW|PBO-QOW
189238|NCT01415401|B1|Baseline|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
189239|NCT01415401|P1|Participant Flow|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
189240|NCT01415401|O1|Outcome|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
189241|NCT01415401|O1|Outcome|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
189242|NCT01415401|E1|Reported Event|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
189243|NCT01415349|B1|Baseline|Safety Analysis Set|Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
189244|NCT01415349|P2|Participant Flow|SSP-002358 + Omeprazole First|A single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 in treatment period 2
189245|NCT01415349|P1|Participant Flow|SSP-002358 First|A single dose of 1 mg SSP-002358 in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 2
189246|NCT01415349|O2|Outcome|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
189247|NCT01415349|O1|Outcome|SSP-002358 Alone|All subjects that received only SSP-002358
189248|NCT01415349|O2|Outcome|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
189249|NCT01415349|O1|Outcome|SSP-002358 Alone|All subjects that received only SSP-002358
189250|NCT01415349|E2|Reported Event|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
189251|NCT01415349|E1|Reported Event|SSP-002358 Alone|All subjects that received only SSP-002358
189252|NCT01415232|B1|Baseline|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
189253|NCT01415232|P1|Participant Flow|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
189254|NCT01415232|O1|Outcome|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth from the skin to the epidural space in morbidly obese parturients
189255|NCT01415232|E1|Reported Event|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
189293|NCT01414413|P2|Participant Flow|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
189256|NCT01414855|B1|Baseline|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189257|NCT01414855|P1|Participant Flow|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.
189258|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189259|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189260|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189261|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189262|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189263|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189264|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189265|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189266|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189267|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189268|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189269|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189270|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189271|NCT01414855|E1|Reported Event|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
189272|NCT01414634|B1|Baseline|ETIMS Dose Escalation|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
189273|NCT01414634|P8|Participant Flow|ETIMS 3x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
189274|NCT01414634|P7|Participant Flow|ETIMS 2.5x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
189275|NCT01414634|P6|Participant Flow|ETIMS 1x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
189276|NCT01414634|P5|Participant Flow|ETIMS 5x10^8|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
189277|NCT01414634|P4|Participant Flow|ETIMS 1x10^8|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
189278|NCT01414634|P3|Participant Flow|ETIMS 1x10^7|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
189279|NCT01414634|P2|Participant Flow|ETIMS 1x10^5|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
189280|NCT01414634|P1|Participant Flow|ETIMS 1x10^3|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
189281|NCT01414634|O1|Outcome|ETIMS Dose Escalation|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
189282|NCT01414634|E8|Reported Event|ETIMS 3x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
189283|NCT01414634|E7|Reported Event|ETIMS 2.5x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
189284|NCT01414634|E6|Reported Event|ETIMS 1x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
189285|NCT01414634|E5|Reported Event|ETIMS 5x10^8|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
189286|NCT01414634|E4|Reported Event|ETIMS 1x10^8|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
189287|NCT01414634|E3|Reported Event|ETIMS 1x10^7|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
189288|NCT01414634|E2|Reported Event|ETIMS 1x10^5|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
189289|NCT01414634|E1|Reported Event|ETIMS 1x10^3|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
189290|NCT01414413|B3|Baseline|Total|Total of all reporting groups
189291|NCT01414413|B2|Baseline|Clinic-based ART Assessment and Initiation|8466 adults resident in 3397 households
189292|NCT01414413|B1|Baseline|Home Assessment and Initiation of ART|8194 adults resident in 3213 households
192035|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
189296|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
189297|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
189298|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
189299|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
189300|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
189301|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
189302|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
189303|NCT01414413|E2|Reported Event|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
189304|NCT01414413|E1|Reported Event|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
189305|NCT01414244|B3|Baseline|Total|Total of all reporting groups
189306|NCT01414244|B2|Baseline|Placebo|Oral Whey Protein Powder
189307|NCT01414244|B1|Baseline|Glutamine|Oral Glutamine Powder
189308|NCT01414244|P2|Participant Flow|Placebo|Oral Whey Protein Powder
189309|NCT01414244|P1|Participant Flow|Glutamine|Oral Glutamine Powder
189310|NCT01414244|O2|Outcome|Placebo|Oral Whey Protein Powder
189311|NCT01414244|O1|Outcome|Glutamine|Oral Glutamine Powder
189312|NCT01414244|O2|Outcome|Placebo|Oral Whey Protein Powder
189313|NCT01414244|O1|Outcome|Glutamine|Oral Glutamine Powder
189314|NCT01414244|O2|Outcome|Placebo|Oral Whey Protein Powder
189315|NCT01414244|O1|Outcome|Glutamine|Oral Glutamine Powder
189316|NCT01414244|O2|Outcome|Placebo|Oral Whey Protein Powder
189317|NCT01414244|O1|Outcome|Glutamine|Oral Glutamine Powder
189318|NCT01414244|E2|Reported Event|Placebo|Oral Whey Protein Powder
189319|NCT01414244|E1|Reported Event|Glutamine|Oral Glutamine Powder
189320|NCT01414205|B3|Baseline|Total|Total of all reporting groups
189321|NCT01414205|B2|Baseline|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189322|NCT01414205|B1|Baseline|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189323|NCT01414205|P2|Participant Flow|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189324|NCT01414205|P1|Participant Flow|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189325|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189326|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189327|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189328|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189329|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189330|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189331|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189332|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189333|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189334|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189335|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189364|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
189336|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189337|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189338|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189339|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189340|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189341|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189342|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189343|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189344|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189345|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189346|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189347|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189348|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189349|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189350|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189351|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189352|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189353|NCT01414205|E2|Reported Event|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189354|NCT01414205|E1|Reported Event|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
189355|NCT01414192|B5|Baseline|Total|Total of all reporting groups
189356|NCT01414192|B4|Baseline|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
189357|NCT01414192|B3|Baseline|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
189358|NCT01414192|B2|Baseline|Ezetimibe Monotherpay With Prior Treatment|Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189359|NCT01414192|B1|Baseline|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189360|NCT01414192|P4|Participant Flow|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
189361|NCT01414192|P3|Participant Flow|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
189362|NCT01414192|P2|Participant Flow|Ezetimibe Monotherpay With Prior Treatment|Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189363|NCT01414192|P1|Participant Flow|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189365|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
189366|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189367|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189368|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
189369|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
189370|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189371|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189372|NCT01414192|O3|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
189373|NCT01414192|O2|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
189374|NCT01414192|O1|Outcome|Ezetimibe Monotherapy With or Without Prior Treatment|Enrolled participants with or without prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189375|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
189376|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
189377|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189378|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189379|NCT01414192|O3|Outcome|Ezetimibe Plus Statin or Ezetimibe/Simvastatin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin or were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
189380|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189381|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189382|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
189383|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
189384|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189385|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189386|NCT01414192|E4|Reported Event|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
189387|NCT01414192|E3|Reported Event|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
189388|NCT01414192|E2|Reported Event|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189389|NCT01414192|E1|Reported Event|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
189390|NCT01414166|B3|Baseline|Total|Total of all reporting groups
189391|NCT01414166|B2|Baseline|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189392|NCT01414166|B1|Baseline|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189393|NCT01414166|P2|Participant Flow|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189394|NCT01414166|P1|Participant Flow|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189395|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189396|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189397|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189398|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189399|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189400|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189401|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189402|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189403|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189404|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189405|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189406|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189407|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189408|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189409|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189410|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189411|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189412|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189413|NCT01414166|E2|Reported Event|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189414|NCT01414166|E1|Reported Event|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
189415|NCT01414153|B5|Baseline|Total|Total of all reporting groups
189416|NCT01414153|B4|Baseline|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
189417|NCT01414153|B3|Baseline|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189418|NCT01414153|B2|Baseline|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189419|NCT01414153|B1|Baseline|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
189420|NCT01414153|P4|Participant Flow|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
189421|NCT01414153|P3|Participant Flow|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189422|NCT01414153|P2|Participant Flow|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189423|NCT01414153|P1|Participant Flow|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
189424|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
189425|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189426|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189427|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
189428|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
189429|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189430|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189431|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
189432|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
189433|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189434|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189435|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
189436|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
189437|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189438|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189439|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
189440|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
189441|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189442|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189443|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
189444|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
189445|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189446|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189447|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
189448|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
189449|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189450|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189451|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
189452|NCT01414153|E4|Reported Event|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
189453|NCT01414153|E3|Reported Event|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189454|NCT01414153|E2|Reported Event|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
189455|NCT01414153|E1|Reported Event|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
189456|NCT01414114|B1|Baseline|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
189457|NCT01414114|P1|Participant Flow|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
189458|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
189459|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
189460|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
189461|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
189462|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
189463|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
189464|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
189465|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
189535|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189466|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
189467|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
189468|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
189469|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
189470|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
189471|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
189472|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
189473|NCT01414114|E1|Reported Event|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
189474|NCT01414036|B3|Baseline|Total|Total of all reporting groups
189475|NCT01414036|B2|Baseline|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
189476|NCT01414036|B1|Baseline|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
189477|NCT01414036|P2|Participant Flow|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
189478|NCT01414036|P1|Participant Flow|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
189479|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
189480|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
189481|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
189482|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
189483|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
189484|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
189485|NCT01414036|E2|Reported Event|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
189536|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189486|NCT01414036|E1|Reported Event|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
189487|NCT01414010|B5|Baseline|Total|Total of all reporting groups
189488|NCT01414010|B4|Baseline|Control|Control group, no intervention given.
189489|NCT01414010|B3|Baseline|Antibiotic|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
189490|NCT01414010|B2|Baseline|Probiotic|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
189491|NCT01414010|B1|Baseline|Prebiotic|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
189492|NCT01414010|P4|Participant Flow|Control|Control group, no intervention given.
189493|NCT01414010|P3|Participant Flow|Antibiotic|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
189494|NCT01414010|P2|Participant Flow|Probiotic|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
189495|NCT01414010|P1|Participant Flow|Prebiotic|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
189496|NCT01414010|O10|Outcome|Saccharomyces Boulardii - After Treatment|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
189497|NCT01414010|O9|Outcome|Saccharomyces Boulardii - During Treatment|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
189498|NCT01414010|O8|Outcome|Saccharomyces Boulardii - Before Treatment|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
189499|NCT01414010|O7|Outcome|Trametes Versicolor Extract - After Treatment|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
189500|NCT01414010|O6|Outcome|Trametes Versicolor Extract - During Treatment|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
189501|NCT01414010|O5|Outcome|Trametes Versicolor Extract - Before Treatment|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
189502|NCT01414010|O4|Outcome|Control|Control group - no intervention given.
189503|NCT01414010|O3|Outcome|Amoxicillin - After Treatment|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
189504|NCT01414010|O2|Outcome|Amoxicillin - During Treatment|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
189505|NCT01414010|O1|Outcome|Amoxicillin - Before Treatment|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
189506|NCT01414010|E4|Reported Event|Control|Control group, no intervention given.
189507|NCT01414010|E3|Reported Event|Antibiotic|Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
189508|NCT01414010|E2|Reported Event|Probiotic|Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days
189509|NCT01414010|E1|Reported Event|Prebiotic|Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days
189510|NCT01413958|B3|Baseline|Total|Total of all reporting groups
189511|NCT01413958|B2|Baseline|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189512|NCT01413958|B1|Baseline|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189513|NCT01413958|P2|Participant Flow|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189514|NCT01413958|P1|Participant Flow|Phenylephrine|Phenylephrine hydrochloride, 30 mg extended-release tablets, one tablet every 12 hours for 7 days
189515|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189516|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189517|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189518|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189519|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189520|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189521|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189522|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189523|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189524|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189525|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189526|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189527|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189528|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189529|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride 30 mg extended release tablets, one dose every 12 hours for 7 days
189530|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189531|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189532|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189533|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189534|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189537|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189538|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189539|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189540|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189541|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189542|NCT01413958|E2|Reported Event|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189543|NCT01413958|E1|Reported Event|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
189544|NCT01413750|B5|Baseline|Total|Total of all reporting groups
189545|NCT01413750|B4|Baseline|Phase II (Placebo)|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189546|NCT01413750|B3|Baseline|Phase II (Vorinostat)|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Vorinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189547|NCT01413750|B2|Baseline|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Vorinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189548|NCT01413750|B1|Baseline|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Vorinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189549|NCT01413750|P4|Participant Flow|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189550|NCT01413750|P3|Participant Flow|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Vorinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189551|NCT01413750|P2|Participant Flow|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Vorinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189552|NCT01413750|P1|Participant Flow|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Vorinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189553|NCT01413750|O1|Outcome|Phase I|All patients enrolled on the Phase I (safety lead-in) portion of the study.
189554|NCT01413750|O2|Outcome|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Vorinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189555|NCT01413750|O1|Outcome|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Vorinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189556|NCT01413750|O2|Outcome|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189557|NCT01413750|O1|Outcome|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Vorinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189558|NCT01413750|E4|Reported Event|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189559|NCT01413750|E3|Reported Event|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Voninostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189560|NCT01413750|E2|Reported Event|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Vorinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189623|NCT01412957|P2|Participant Flow|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
192036|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
189561|NCT01413750|E1|Reported Event|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.
Paclitaxel: Given IV
Carboplatin: Given IV
Vorinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies"
189562|NCT01413542|B3|Baseline|Total|Total of all reporting groups
189563|NCT01413542|B2|Baseline|Group 2|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
189564|NCT01413542|B1|Baseline|Group 1|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
189565|NCT01413542|P4|Participant Flow|Sitagliptin (DPP4 Inhibition) Then Placebo = Group 2|Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
189566|NCT01413542|P3|Participant Flow|Placebo Then Sitagliptin (DPP4 Inhibition)=Group 2|Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
189567|NCT01413542|P2|Participant Flow|Sitagliptin (DPP4 Inhibition) Then Placebo=Group 1|Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
189568|NCT01413542|P1|Participant Flow|Placebo Then Sitagliptin (DPP4 Inhibibition)=Group 1|Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
189569|NCT01413542|O1|Outcome|Group 2|The effect of treatment (placebo vs. DPP4 inhibition) on venous GLP-1 levels during intra-arterial GLP-1 infusion.
189570|NCT01413542|O1|Outcome|Group 1|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
189571|NCT01413542|O1|Outcome|Group 1|The effect of ACE and/or DPP4 inhibition on change in heart rate in response to substance P (SP) was evaluated.
189572|NCT01413542|O2|Outcome|Group 1 (Females)|The effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) was evaluated.
189573|NCT01413542|O1|Outcome|Group 1 (Males)|The effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) was evaluated.
189574|NCT01413542|O2|Outcome|Group 2|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effect of study drug on FBF response to glucagon like peptide-1 (peptide 1) and brain natriuretic peptide (peptide 2) was studied.
189575|NCT01413542|O1|Outcome|Group 1|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
189576|NCT01413542|E4|Reported Event|Group 2 (Sitagliptin Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
189577|NCT01413542|E3|Reported Event|Group 2 (Placebo Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
189578|NCT01413542|E2|Reported Event|Group 1 (Sitagliptin Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
189579|NCT01413542|E1|Reported Event|Group 1 (Placebo Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
189580|NCT01413516|B3|Baseline|Total|Total of all reporting groups
189581|NCT01413516|B2|Baseline|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental
Interventions:
Behavioral: smoking counseling
Drug: varenicline
Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline
Varenicline: Varenicline (an approved medication for smoking cessation)"
189582|NCT01413516|B1|Baseline|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator
Interventions:
Behavior: smoking counseling
Drug: placebo (sugar pill without any active medication)
Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study
Placebo: Sugar pill without any active medication"
189583|NCT01413516|P2|Participant Flow|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental
Interventions:
Behavioral: smoking counseling
Drug: varenicline
Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline
Varenicline: Varenicline (an approved medication for smoking cessation)"
189584|NCT01413516|P1|Participant Flow|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator
Interventions:
Behavior: smoking counseling
Drug: placebo (sugar pill without any active medication)
Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo
Placebo: Sugar pill without any active medication"
189585|NCT01413516|O2|Outcome|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental
Interventions:
Behavioral: smoking counseling
Drug: varenicline
Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline
Varenicline: Varenicline (an approved medication for smoking cessation)"
189586|NCT01413516|O1|Outcome|Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator
Interventions:
Behavior: smoking counseling
Drug: placebo (sugar pill without any active medication)
Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study
Placebo: Sugar pill without any active medication"
189587|NCT01413516|E2|Reported Event|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental
Interventions:
Behavioral: smoking counseling
Drug: varenicline
Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline
Varenicline: Varenicline (an approved medication for smoking cessation)"
189588|NCT01413516|E1|Reported Event|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator
Interventions:
Behavior: smoking counseling
Drug: placebo (sugar pill without any active medication)
Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo
Placebo: Sugar pill without any active medication"
189589|NCT01413360|B1|Baseline|HD Vitamin C|"High dose vitamin C
High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
189590|NCT01413360|P1|Participant Flow|HD Vitamin C|"High dose vitamin C
High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
189591|NCT01413360|O1|Outcome|HD Vitamin C|"High dose vitamin C
High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
189592|NCT01413360|O1|Outcome|HD Vitamin C|"High dose vitamin C
High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
189593|NCT01413360|E1|Reported Event|HD Vitamin C|"High dose vitamin C
High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
189594|NCT01413204|B4|Baseline|Total|Total of all reporting groups
189595|NCT01413204|B3|Baseline|Placebo|TA-7284 Placebo, once daily for 24 weeks
189596|NCT01413204|B2|Baseline|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
189597|NCT01413204|B1|Baseline|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
189598|NCT01413204|P3|Participant Flow|Placebo|TA-7284 Placebo, once daily for 24 weeks
189599|NCT01413204|P2|Participant Flow|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
189600|NCT01413204|P1|Participant Flow|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
189601|NCT01413204|O3|Outcome|Placebo|TA-7284 Placebo, once daily for 24 weeks
189602|NCT01413204|O2|Outcome|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
189603|NCT01413204|O1|Outcome|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
189604|NCT01413204|E3|Reported Event|Placebo|TA-7284 Placebo, once daily for 24 weeks
189605|NCT01413204|E2|Reported Event|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
189606|NCT01413204|E1|Reported Event|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
189607|NCT01413191|B1|Baseline|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
189608|NCT01413191|P1|Participant Flow|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
189609|NCT01413191|O1|Outcome|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
189610|NCT01413191|E1|Reported Event|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
189611|NCT01412983|B1|Baseline|Overall Study|All 99 participants in study
189612|NCT01412983|P2|Participant Flow|Ciba Vision Soft Contact Lens Then Bausch+Lomb Test Lens|"Ciba Vision Air Optix Aqua soft contact lens
Ciba Vision lens:Bausch+Lomb Test Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
189613|NCT01412983|P1|Participant Flow|Bausch+Lomb Test Lens Then Ciba Vision Lens|"Bausch+Lomb investigational soft contact lens
Bausch+Lomb Test lens:Ciba Vision Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
189614|NCT01412983|O2|Outcome|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens
Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
189615|NCT01412983|O1|Outcome|Bausch + Lomb Test Lens|"Bausch + Lomb investigational soft contact lens
Bausch + Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
189616|NCT01412983|O2|Outcome|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens
Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
189617|NCT01412983|O1|Outcome|Bausch+Lomb Test Lens|"Bausch+Lomb investigational soft contact lens
Bausch+Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch+Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
189618|NCT01412983|E2|Reported Event|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens
Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
189619|NCT01412983|E1|Reported Event|Bausch & Lomb Test Lens|"Bausch + Lomb investigational soft contact lens
Bausch & Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
189620|NCT01412957|B3|Baseline|Total|Total of all reporting groups
189621|NCT01412957|B2|Baseline|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
189622|NCT01412957|B1|Baseline|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
189624|NCT01412957|P1|Participant Flow|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
189625|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
189626|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
189627|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
189628|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
189629|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
189630|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
189631|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
189632|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
189633|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
189634|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
189635|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
189636|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
189637|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
189638|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
189639|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
189640|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
189641|NCT01412957|E2|Reported Event|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
189642|NCT01412957|E1|Reported Event|Panitumumab Plus BSC|
189643|NCT01412944|B3|Baseline|Total|Total of all reporting groups
189644|NCT01412944|B2|Baseline|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189645|NCT01412944|B1|Baseline|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189646|NCT01412944|P6|Participant Flow|AIN457 300 mg - AIN457 10 mg/kg I.V.|
189647|NCT01412944|P5|Participant Flow|AIN457 150 mg - AIN457 10 mg/kg I.V.|
189648|NCT01412944|P4|Participant Flow|AIN457 300 mg - AIN457 300 mg s.c.|
189649|NCT01412944|P3|Participant Flow|I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.|
189650|NCT01412944|P2|Participant Flow|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189651|NCT01412944|P1|Participant Flow|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189652|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189653|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189654|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189655|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189656|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189657|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189658|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189659|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189660|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189661|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189662|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189663|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189664|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189665|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189666|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189667|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189668|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189669|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189670|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189671|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
189672|NCT01412944|E12|Reported Event|Follow-up: AIN457 150 mg - 10 mg/kg i.v.|
189673|NCT01412944|E11|Reported Event|Follow-up: AIN457 150 mg - 300 mg s.c.|
189674|NCT01412944|E10|Reported Event|Follow-up: AIN457 300 mg - 10 mg/kg i.v.|
189675|NCT01412944|E9|Reported Event|Follow up: AIN457 300 mg - AIN457 300 mg s.c.|
189676|NCT01412944|E8|Reported Event|Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v.|
189677|NCT01412944|E7|Reported Event|Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v.|
189678|NCT01412944|E6|Reported Event|Entire Period: AIN457 300 mg - AIN457 300 mg s.c.|
189679|NCT01412944|E5|Reported Event|Entire Period: AIN457 150 mg - AIN457 300 mg s.c.|
189680|NCT01412944|E4|Reported Event|I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v.|
189681|NCT01412944|E3|Reported Event|I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v.|
189682|NCT01412944|E2|Reported Event|I.V. Period: AIN457 300 mg - AIN457 300 mg s.c.|
189683|NCT01412944|E1|Reported Event|I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.|
189684|NCT01412918|B3|Baseline|Total|Total of all reporting groups
189685|NCT01412918|B2|Baseline|No Tinnitus|Individuals without tinnitus.
189686|NCT01412918|B1|Baseline|Tinnitus|"Individual with tinnitus.
The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
189687|NCT01412918|P2|Participant Flow|No Tinnitus|Individuals without tinnitus.
189688|NCT01412918|P1|Participant Flow|Tinnitus|"Individual with tinnitus.
The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
189689|NCT01412918|O2|Outcome|No Tinnitus|Individuals without tinnitus.
189690|NCT01412918|O1|Outcome|Tinnitus|"Individual with tinnitus.
The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
189691|NCT01412918|O1|Outcome|Tinnitus|Tinnitus. genetic sample collection (no intervention)
189692|NCT01412918|E2|Reported Event|No Tinnitus|Individuals without tinnitus.
189693|NCT01412918|E1|Reported Event|Tinnitus|"Individual with tinnitus. Intervention: inhibitor device demonstration.
The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
189694|NCT01412879|B3|Baseline|Total|Total of all reporting groups
189695|NCT01412879|B2|Baseline|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
189696|NCT01412879|B1|Baseline|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
189697|NCT01412879|P3|Participant Flow|Consolidation Therapy: Stem Cell Transplant|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.
TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
189698|NCT01412879|P2|Participant Flow|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
189699|NCT01412879|P1|Participant Flow|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
189700|NCT01412879|O2|Outcome|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
189701|NCT01412879|O1|Outcome|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
189702|NCT01412879|O2|Outcome|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
189703|NCT01412879|O1|Outcome|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
189704|NCT01412879|O3|Outcome|Stem Cell Transplant (Consolidation Therapy)|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.
TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
189705|NCT01412879|O2|Outcome|R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
189726|NCT01412801|O2|Outcome|HIVposCD4HIGH|Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
189706|NCT01412879|O1|Outcome|R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
189707|NCT01412879|O2|Outcome|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
189708|NCT01412879|O1|Outcome|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
189709|NCT01412879|E3|Reported Event|Stem Cell Transplant (Consolidation Therapy)|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.
TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
189710|NCT01412879|E2|Reported Event|R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
189711|NCT01412879|E1|Reported Event|R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
189712|NCT01412801|B7|Baseline|Total|Total of all reporting groups
189713|NCT01412801|B6|Baseline|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
189714|NCT01412801|B5|Baseline|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
189715|NCT01412801|B4|Baseline|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
189716|NCT01412801|B3|Baseline|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189717|NCT01412801|B2|Baseline|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189718|NCT01412801|B1|Baseline|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189719|NCT01412801|P6|Participant Flow|HIVneg(Infants)|Infants born to HIV-antibody negative maternal subjects
189720|NCT01412801|P5|Participant Flow|HIVposCD4HIGH(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
189721|NCT01412801|P4|Participant Flow|HIVposCD4LOW(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
189722|NCT01412801|P3|Participant Flow|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189723|NCT01412801|P2|Participant Flow|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189724|NCT01412801|P1|Participant Flow|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189725|NCT01412801|O3|Outcome|HIVneg|"Maternal subjects: HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.
Infants: Infants born to HIV-antibody negative maternal subjects"
189761|NCT01412541|B2|Baseline|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189727|NCT01412801|O1|Outcome|HIVposCD4LOW|Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
189728|NCT01412801|O3|Outcome|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
189729|NCT01412801|O2|Outcome|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
189730|NCT01412801|O1|Outcome|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
189731|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189732|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189733|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189734|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189735|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189736|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189737|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189738|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189739|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189740|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.
189741|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189742|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189743|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189744|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189745|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189746|NCT01412801|O6|Outcome|HIVneg(Infants)|Infants born to HIV-antibody negative maternal subjects
189747|NCT01412801|O5|Outcome|HIVposCD4HIGH(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
189748|NCT01412801|O4|Outcome|HIVposCD4LOW(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
189749|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189750|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189751|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
189752|NCT01412801|E8|Reported Event|Total Maternal Subjects|Total number of Maternal subjects participated in the study
189753|NCT01412801|E7|Reported Event|HIVneg_Maternal Subjects|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
189754|NCT01412801|E6|Reported Event|HIVposCD4HIGH_Maternal Subjects|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
189755|NCT01412801|E5|Reported Event|HIVposCD4LOW_Maternal Subjects|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/μL but > 50 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
189756|NCT01412801|E4|Reported Event|Total (Infants)|Total number of Infants participated in the study
189757|NCT01412801|E3|Reported Event|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
189758|NCT01412801|E2|Reported Event|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/μL .
189759|NCT01412801|E1|Reported Event|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/μL but > 50 cells/μL
189760|NCT01412541|B3|Baseline|Total|Total of all reporting groups
189762|NCT01412541|B1|Baseline|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189763|NCT01412541|P2|Participant Flow|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189764|NCT01412541|P1|Participant Flow|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189765|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189766|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189767|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189768|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189769|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189770|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189771|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189772|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189773|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189774|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189775|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189776|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189777|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189778|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189779|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189780|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189781|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189782|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189783|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189784|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189785|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189786|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189787|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189788|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189789|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189790|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189791|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189792|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189793|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189794|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189795|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189796|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189797|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189798|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189799|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189800|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189801|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189802|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189803|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189804|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189805|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189806|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189807|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189808|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189809|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189810|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189811|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189812|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189813|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189814|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189815|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189816|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189817|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189818|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189819|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189820|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189821|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
192037|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
189822|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189823|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189824|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189825|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189826|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189827|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189828|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189829|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189830|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189831|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189832|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189833|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189834|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189835|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189836|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189837|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189838|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189839|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189840|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189841|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189842|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189843|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189844|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189845|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189846|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189847|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189848|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189849|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189850|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189851|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
192038|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
189852|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189853|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189854|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189855|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189856|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189857|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189858|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189859|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189860|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189861|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189862|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189863|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189864|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189865|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189866|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189867|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189868|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189869|NCT01412541|E2|Reported Event|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189870|NCT01412541|E1|Reported Event|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter
Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
189871|NCT01412424|B1|Baseline|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
189872|NCT01412424|P1|Participant Flow|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
189873|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
189874|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
189875|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
189876|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
189877|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
190160|NCT01411137|O1|Outcome|Part 1: Conversion|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
189878|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
189879|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
189880|NCT01412424|O4|Outcome|Octreotide 40, 60, or 80 mg - All Participants|Participants received octreotide 40, 60, or 80 mg orally for up to 13 months.
189881|NCT01412424|O3|Outcome|Octreotide 80 mg|Participants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months.
189882|NCT01412424|O2|Outcome|Octreotide 60 mg|Participants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months.
189883|NCT01412424|O1|Outcome|Octreotide 40 mg|Participants received octreotide 20 mg orally twice a day for up to 13 months.
189884|NCT01412424|E3|Reported Event|Octreotide 80 mg|Participants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months.
189885|NCT01412424|E2|Reported Event|Octreotide 60 mg|Participants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months.
189886|NCT01412424|E1|Reported Event|Octreotide 40 mg|Participants received octreotide 20 mg orally twice a day for up to 13 months.
189887|NCT01412333|B3|Baseline|Total|Total of all reporting groups
189888|NCT01412333|B2|Baseline|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189889|NCT01412333|B1|Baseline|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189890|NCT01412333|P2|Participant Flow|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189891|NCT01412333|P1|Participant Flow|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189892|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189893|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189894|NCT01412333|O1|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189895|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189896|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189897|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189898|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189899|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189900|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189901|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189902|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189903|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189904|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189905|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189906|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189907|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
190032|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
189908|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189909|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189910|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189911|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189912|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189913|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189914|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189915|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189916|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189917|NCT01412333|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189918|NCT01412333|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189919|NCT01412333|E2|Reported Event|Ocrelizumab|Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
189920|NCT01412333|E1|Reported Event|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
189921|NCT01412281|B5|Baseline|Total|Total of all reporting groups
189922|NCT01412281|B4|Baseline|>60 Years - CSL HA Antigen|
189923|NCT01412281|B3|Baseline|>60 Years - AdImmune HA Antigen|
189924|NCT01412281|B2|Baseline|≥18 to ≤60 Years - CSL HA Antigen|
189925|NCT01412281|B1|Baseline|≥18 to ≤60 Years - AdImmune HA Antigen|
189926|NCT01412281|P4|Participant Flow|>60 Years - CSL HA Antigen|
189927|NCT01412281|P3|Participant Flow|>60 Years - AdImmune HA Antigen|
189928|NCT01412281|P2|Participant Flow|≥18 to ≤60 Years - CSL HA Antigen|
189929|NCT01412281|P1|Participant Flow|≥18 to ≤60 Years - AdImmune HA Antigen|
189930|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
189931|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
189932|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
189933|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
189934|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
189935|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
189936|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
189937|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
189938|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
189939|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
189940|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
189941|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
189942|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
189943|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
189944|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
189945|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
189946|NCT01412281|E4|Reported Event|>60 Years - CSL HA Antigen|
189947|NCT01412281|E3|Reported Event|>60 Years - AdImmune HA Antigen|
189948|NCT01412281|E2|Reported Event|≥18 to ≤60 Years - CSL HA Antigen|
189949|NCT01412281|E1|Reported Event|≥18 to ≤60 Years - AdImmune HA Antigen|
189950|NCT01412229|B1|Baseline|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin AUC2 (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
189951|NCT01412229|P1|Participant Flow|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin Area under the Curve (AUC2) (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
189952|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin AUC2 (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
190161|NCT01411137|E4|Reported Event|Overall|All treated subjects
189953|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin AUC2 (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
189954|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin AUC2 (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
189955|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin AUC2 (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
189956|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin AUC2 (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
189957|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin area under curve (AUC)2 (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
189958|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin AUC2 (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
189959|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin AUC2 (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
189960|NCT01412229|O1|Outcome|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin AUC2 (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
189961|NCT01412229|E1|Reported Event|Treatment|"nab-paclitaxel 100mg/m2
Carboplatin AUC2 (IV)
Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks."
189962|NCT01412164|B1|Baseline|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD
FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
189963|NCT01412164|P1|Participant Flow|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD
FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
189964|NCT01412164|O1|Outcome|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD
FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
189965|NCT01412164|E1|Reported Event|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD
FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
189966|NCT01412151|B1|Baseline|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
189967|NCT01412151|P1|Participant Flow|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
189968|NCT01412151|O1|Outcome|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
189969|NCT01412151|E1|Reported Event|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
189970|NCT01412086|B1|Baseline|All Participants|Healthy volunteers. No treatment (intervention) was received.
189971|NCT01412086|P1|Participant Flow|All Participants|Healthy volunteers. No treatment (intervention) was received.
189972|NCT01412086|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was received.
189973|NCT01412086|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was received.
189974|NCT01412086|E1|Reported Event|All Participants|Healthy volunteers. No treatment (intervention) was received.
189975|NCT01411891|B3|Baseline|Total|Total of all reporting groups
189976|NCT01411891|B2|Baseline|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
189977|NCT01411891|B1|Baseline|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
189978|NCT01411891|P2|Participant Flow|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
189979|NCT01411891|P1|Participant Flow|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
189980|NCT01411891|O2|Outcome|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
189981|NCT01411891|O1|Outcome|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
189982|NCT01411891|E2|Reported Event|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
189983|NCT01411891|E1|Reported Event|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
189984|NCT01411852|B3|Baseline|Total|Total of all reporting groups
189985|NCT01411852|B2|Baseline|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
189986|NCT01411852|B1|Baseline|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
189987|NCT01411852|P2|Participant Flow|0.9% Sodium Chloride 250 mL Bolus|"0.9% Sodium Chloride 250 mL bolus - A large bore IV will be placed and a 250cc bag of normal saline (NS) will be hung. If IV placement is difficult, NS can be given through an intraosseous line. The procedure will continue until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.
0.9% Sodium Chloride 250 mL bolus: Either systolic blood pressure (SBP) or radial pulse is the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients receive 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS is given only to keep the vein open. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first."
189988|NCT01411852|P1|Participant Flow|0.9% Sodium Chloride 2000 mL Bolus|"0.9% Sodium Chloride 2000 mL bolus - An intravenous line (IV) will be placed and a 1000cc bag of normal saline will be hung. If IV placement is difficult, fluid can be given through an intraosseous line. This procedure will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.
0.9% Sodium Chloride 2000 mL bolus: The systolic blood pressure (SBP) is the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. Once the total fluid reaches 2 liters and the SBP exceeds 110 mmHg, the fluid will be stopped and restarted as necessary to maintain a goal SBP of 110 mmHg."
189989|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
189990|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
189991|NCT01411852|O2|Outcome|Controlled Resuscitation|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
189992|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
189993|NCT01411852|O2|Outcome|Controlled Resuscitation|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
189994|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
189995|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
189996|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
189997|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
189998|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
189999|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190000|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190001|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190002|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190033|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
190003|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190004|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190005|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190006|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190007|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190008|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190009|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190010|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190011|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190012|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190013|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190014|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190015|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190016|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190017|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190018|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190019|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190020|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190021|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190022|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190023|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190024|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190025|NCT01411852|O3|Outcome|ECV Difference [Standard - Controlled]|ECV treatment difference between SR and CR
190026|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
190027|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190028|NCT01411852|E2|Reported Event|Controlled Resuscitation (CR)|"Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
The total number of patients at risk is one less than the total number of patients enrolled. Regulatory restrictions for prisoners required that no data collection, including severe adverse events, be performed for the patient who was determined to have been in police custody at the time of enrollment."
190029|NCT01411852|E1|Reported Event|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
190030|NCT01411696|B1|Baseline|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
190031|NCT01411696|P1|Participant Flow|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
190034|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
190035|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
190036|NCT01411696|E1|Reported Event|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
190037|NCT01411592|B3|Baseline|Total|Total of all reporting groups
190038|NCT01411592|B2|Baseline|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Patients were recalled after 6 and 12 months, and then annually."
190039|NCT01411592|B1|Baseline|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).
Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).
Patients were recalled after 6 and 12 months, and then annually."
190040|NCT01411592|P2|Participant Flow|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Patients were recalled after 6 and 12 months, and then annually."
190041|NCT01411592|P1|Participant Flow|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).
Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).
Patients were recalled after 6 and 12 months, and then annually."
190042|NCT01411592|O2|Outcome|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Patients were recalled after 6 and 12 months, and then annually."
190043|NCT01411592|O1|Outcome|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).
Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).
Patients were recalled after 6 and 12 months, and then annually."
190044|NCT01411592|O2|Outcome|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Patients were recalled after 6 and 12 months, and then annually."
190045|NCT01411592|O1|Outcome|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).
Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).
Patients were recalled after 6 and 12 months, and then annually."
190046|NCT01411592|E2|Reported Event|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Patients were recalled after 6 and 12 months, and then annually."
190047|NCT01411592|E1|Reported Event|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).
Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).
Patients were recalled after 6 and 12 months, and then annually."
190048|NCT01411501|B5|Baseline|Total|Total of all reporting groups
190049|NCT01411501|B4|Baseline|Medicine|"oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
190050|NCT01411501|B3|Baseline|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190322|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190051|NCT01411501|B2|Baseline|Acupuncture at LI11 and ST37|"the points formula of He-points
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190052|NCT01411501|B1|Baseline|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190053|NCT01411501|P4|Participant Flow|Medicine|"oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
190054|NCT01411501|P3|Participant Flow|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190055|NCT01411501|P2|Participant Flow|Acupuncture at LI11 and ST37|"the points formula of He-points
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190056|NCT01411501|P1|Participant Flow|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190057|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
190058|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190059|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190060|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190061|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
190122|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190328|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190062|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190063|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190064|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190065|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
190066|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190067|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190068|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190069|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
190070|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190071|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190123|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190124|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190570|NCT01409382|O2|Outcome|Neonates Born to Controls|Neonates with hypoglycemia detected 1, 2 or 4 hours after birth
190072|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190073|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
190074|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190075|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190076|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190077|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
190078|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190079|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190080|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190081|NCT01411501|E4|Reported Event|Medicine|"oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
190082|NCT01411501|E3|Reported Event|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190125|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190696|NCT01408719|B3|Baseline|Sequence 3|3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
190083|NCT01411501|E2|Reported Event|Acupuncture at LI11 and ST37|"the points formula of He-points
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190084|NCT01411501|E1|Reported Event|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
190085|NCT01411228|B4|Baseline|Total|Total of all reporting groups
190086|NCT01411228|B3|Baseline|Dose Adjusted|Taliglucerase alfa: Dose increased from 30 Units/kg to 45 or 60 Units/kg
190087|NCT01411228|B2|Baseline|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190088|NCT01411228|B1|Baseline|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190089|NCT01411228|P3|Participant Flow|Switchover|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190090|NCT01411228|P2|Participant Flow|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190091|NCT01411228|P1|Participant Flow|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190092|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
190093|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190094|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190095|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
190096|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190097|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190098|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
190099|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190100|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190101|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
190102|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190103|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190104|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
190105|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190106|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190107|NCT01411228|E3|Reported Event|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
190108|NCT01411228|E2|Reported Event|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190109|NCT01411228|E1|Reported Event|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
190110|NCT01411215|B3|Baseline|Total|Total of all reporting groups
190111|NCT01411215|B2|Baseline|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190112|NCT01411215|B1|Baseline|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190113|NCT01411215|P2|Participant Flow|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190114|NCT01411215|P1|Participant Flow|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190115|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190116|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190117|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190118|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190119|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190120|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190121|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190126|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190127|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190128|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190129|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190130|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190131|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190132|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190133|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190134|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190135|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190136|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190137|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190138|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190139|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190140|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190141|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190142|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190143|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190144|NCT01411215|E2|Reported Event|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190145|NCT01411215|E1|Reported Event|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
190146|NCT01411137|B1|Baseline|All Study Participants|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, an additional 6-month open-label extension study."
190147|NCT01411137|P1|Participant Flow|IPX066|extended-release CD-LD
190148|NCT01411137|O5|Outcome|Part 1 or 2 Early Termination|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study."
190149|NCT01411137|O4|Outcome|Part 2: Open-Label Extension (Month 6)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
190150|NCT01411137|O3|Outcome|Part 2: Open-Label Extension (Month 3)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
190151|NCT01411137|O2|Outcome|Part 1: Conversion (Week 6)|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
190152|NCT01411137|O1|Outcome|Part 1: Conversion (Baseline)|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
190153|NCT01411137|O4|Outcome|Part 1 or 2 Early Termination|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study."
190154|NCT01411137|O3|Outcome|Part 2: Open-Label Extension (Month 6)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
190155|NCT01411137|O2|Outcome|Part 2: Open-Label Extension (Month 3)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
190156|NCT01411137|O1|Outcome|Part 1: Conversion|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
190157|NCT01411137|O4|Outcome|Part 1 or 2 Early Termination|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study."
190158|NCT01411137|O3|Outcome|Part 2: Open-Label Extension (Month 6)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
190159|NCT01411137|O2|Outcome|Part 2: Open-Label Extension (Month 3)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
190162|NCT01411137|E3|Reported Event|Part 3: Open-Label Extension 2|Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, a 6-month open-label extension study.
190163|NCT01411137|E2|Reported Event|Part 2: Open-Label Extension 1|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
190164|NCT01411137|E1|Reported Event|Part 1: Conversion|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
190165|NCT01410773|B1|Baseline|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.
Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
190166|NCT01410773|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.
Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
190167|NCT01410773|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.
Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
190168|NCT01410773|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.
Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
190169|NCT01410773|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.
Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
190170|NCT01410604|B3|Baseline|Total|Total of all reporting groups
190171|NCT01410604|B2|Baseline|Placebo|
190172|NCT01410604|B1|Baseline|Metformin|
190173|NCT01410604|P2|Participant Flow|Placebo|
190174|NCT01410604|P1|Participant Flow|Metformin|
190175|NCT01410604|O2|Outcome|Placebo|
190176|NCT01410604|O1|Outcome|Metformin|
190177|NCT01410604|O2|Outcome|Placebo|
190178|NCT01410604|O1|Outcome|Metformin|
190179|NCT01410604|O2|Outcome|Placebo|
190180|NCT01410604|O1|Outcome|Metformin|
190181|NCT01410604|O2|Outcome|Placebo|
190182|NCT01410604|O1|Outcome|Metformin|
190183|NCT01410604|O2|Outcome|Placebo|
190184|NCT01410604|O1|Outcome|Metformin|
190185|NCT01410604|O2|Outcome|Placebo|
190186|NCT01410604|O1|Outcome|Metformin|
190187|NCT01410604|O2|Outcome|Placebo|
190188|NCT01410604|O1|Outcome|Metformin|
190189|NCT01410604|O2|Outcome|Placebo|
190190|NCT01410604|O1|Outcome|Metformin|
190191|NCT01410604|E2|Reported Event|Placebo|
190192|NCT01410604|E1|Reported Event|Metformin|
190193|NCT01410565|B3|Baseline|Total|Total of all reporting groups
190194|NCT01410565|B2|Baseline|Placebo|"Placebo
Placebo in the Double Blind Phase"
190195|NCT01410565|B1|Baseline|Apaziquone|"Apaziquone 4 mg in 40 mL diluent
Apaziquone in the Double Blind Phase"
190196|NCT01410565|P3|Participant Flow|Open Label-Apaziquone|
190197|NCT01410565|P2|Participant Flow|Placebo|"Placebo
Placebo: Placebo in the Double Blind Phase"
190198|NCT01410565|P1|Participant Flow|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent
Apaziquone: Apaziquone in the Double Blind Phase"
190199|NCT01410565|O2|Outcome|Placebo|"Placebo
Placebo in the Double Blind Phase"
190200|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent
Apaziquone in the Double Blind Phase"
190201|NCT01410565|O2|Outcome|Placebo|"Placebo
Placebo in the Double Blind Phase"
190202|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent
Apaziquone in the Double Blind Phase"
190203|NCT01410565|O2|Outcome|Placebo|"Placebo
Placebo in the Double Blind Phase"
190204|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent
Apaziquone in the Double Blind Phase"
190205|NCT01410565|E2|Reported Event|Placebo|"Placebo
Placebo: Placebo in the Double Blind Phase"
190206|NCT01410565|E1|Reported Event|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent
Apaziquone: Apaziquone in the Double Blind Phase"
190207|NCT01410474|B3|Baseline|Total|Total of all reporting groups
190208|NCT01410474|B2|Baseline|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190209|NCT01410474|B1|Baseline|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190210|NCT01410474|P2|Participant Flow|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190211|NCT01410474|P1|Participant Flow|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190212|NCT01410474|O3|Outcome|Overall (6-18 Years)|Subjects 6-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
190213|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
190214|NCT01410474|O1|Outcome|6-10 Years|Subjects 6-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
190215|NCT01410474|O1|Outcome|2-5 Years|Subjects 2-5 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
190697|NCT01408719|B2|Baseline|Sequence 2|Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
190216|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190217|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190218|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190219|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190220|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190221|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190222|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190223|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190224|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190225|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190226|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190227|NCT01410474|O1|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190228|NCT01410474|E3|Reported Event|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190229|NCT01410474|E2|Reported Event|11–18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190230|NCT01410474|E1|Reported Event|2–10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
190231|NCT01410448|B3|Baseline|Total|Total of all reporting groups
190232|NCT01410448|B2|Baseline|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190233|NCT01410448|B1|Baseline|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190234|NCT01410448|P2|Participant Flow|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190235|NCT01410448|P1|Participant Flow|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190236|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190237|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190238|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190239|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190240|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190241|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190242|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190243|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190244|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190245|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190329|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190246|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190247|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190248|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190249|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190250|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190251|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190252|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190253|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190254|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190255|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190256|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190257|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190258|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190259|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190260|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190261|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190262|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190263|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190264|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190265|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190266|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190267|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190268|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190269|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190270|NCT01410448|E2|Reported Event|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
190271|NCT01410448|E1|Reported Event|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
190272|NCT01410409|B3|Baseline|Total|Total of all reporting groups
190273|NCT01410409|B2|Baseline|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190274|NCT01410409|B1|Baseline|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190275|NCT01410409|P2|Participant Flow|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190276|NCT01410409|P1|Participant Flow|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190277|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190278|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190279|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190323|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
190324|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190280|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190281|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190282|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190283|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190284|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190285|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190286|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190287|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190325|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
190288|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190289|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190290|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190291|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190292|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190293|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190294|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190295|NCT01410409|E2|Reported Event|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190326|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190327|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190296|NCT01410409|E1|Reported Event|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.
Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.
Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
190297|NCT01410240|B4|Baseline|Total|Total of all reporting groups
190298|NCT01410240|B3|Baseline|FLOSEAL + Standard of Care (SoC) - Run-In|"Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression"
190299|NCT01410240|B2|Baseline|FLOSEAL + Standard of Care (SoC) - Non-Run-In|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression"
190300|NCT01410240|B1|Baseline|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190301|NCT01410240|P3|Participant Flow|FLOSEAL + Standard of Care (SoC) Run-In Participants|"This arm/group only includes the 12 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures and the use of FLOSEAL)
FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190302|NCT01410240|P2|Participant Flow|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190303|NCT01410240|P1|Participant Flow|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190304|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190305|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190306|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190307|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190308|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190309|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190310|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190311|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190312|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190313|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190314|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190315|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190316|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190317|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190318|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190319|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190320|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190321|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression.
Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
190330|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190331|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190332|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190333|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190334|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190335|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190336|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190337|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190338|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190339|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190340|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190341|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190342|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190343|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190344|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190345|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190346|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190347|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190348|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190349|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190350|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190351|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190352|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190353|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190354|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190355|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190356|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190357|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190358|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190359|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190360|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190361|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190362|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190363|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190364|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190365|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190366|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190367|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190368|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190369|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190370|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190371|NCT01410240|E2|Reported Event|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
190372|NCT01410240|E1|Reported Event|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.
SoC: conventional hemostatic techniques such as cautery and manual compression."
190373|NCT01410227|B1|Baseline|All Subjects Treated With Study Product|All subjects treated with study product
190374|NCT01410227|P4|Participant Flow|Arm 4: Treatment Only|In Part A, participants received on-demand treatment for bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] administered together with recombinant Factor VIII [rFVIII] (rVWF:rFVIII) or rVWF alone), where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels. If not available, the individual participant's PK data was used to determine rFVIII dose at discretion of investigator. Participants received on-demand treatment for 6 months after the first study product infusion. In part, B participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months. No pharmacokinetic (PK) assessments were conducted in this arm.
190375|NCT01410227|P3|Participant Flow|Arm 3: PK80 + Treatment|In Part A, participants initially underwent a first PK assessment of an infusion of 80 IU/kg recombinant von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF]. After the first PK assessment participants received on demand treatment for bleeding episodes (BEs) with study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rWVF with or without rFVIII, based on FVIII levels. If FVIII levels not available, the individual participant's PK data was used to determine rFVIII dose at discretion of investigator. Participants received on-demand treatment for 6 months after the first study product infusion. After 6 months participants underwent a second PK assessment of an infusion of 80 IU/kg rVWF. In part B, participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months.
190376|NCT01410227|P2|Participant Flow|Arm 2: PK50 Only|In Part A, (pharmacokinetic [PK] assessment followed by on-demand treatment for bleeding episodes [BEs] for 6 months) participants were initially infused either with 50 IU/kg recombinant von Willebrand Factor:von Willebrand Ristocetin cofactor (VWF:RCo rVWF) [rVWF] administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline. Participants then crossed over to the alternate infusion after washout (PK). For on-demand treatment, participants received study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels (dose based on previous FVIII levels or if not available from the individual participant's PK data at discretion of investigator). Participants then exited the study or could opt to sign informed consent to move to Arm 1 receive treatment for bleeding episodes with study product.
190377|NCT01410227|P1|Participant Flow|Arm 1: PK50 + Treatment|In Part A, (pharmacokinetic [PK] assessment followed by on-demand treatment for bleeding episodes [BEs] for 6 months) participants were initially infused either with 50 IU/kg recombinant von Willebrand Factor:von Willebrand Ristocetin cofactor (VWF:RCo rVWF) [rVWF] administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline. Participants then crossed over to the alternate infusion after washout (PK). For on-demand treatment, participants received study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels (dose based on previous FVIII levels or if not available from the individual participant's PK data at discretion of investigator). In part, B participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months.
190378|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190379|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
192039|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
190380|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190381|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190382|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190383|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190384|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190385|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190386|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190387|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190388|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190389|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190390|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190391|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190392|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190393|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190394|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190395|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190396|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190397|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190398|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190399|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190400|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190401|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
190402|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190403|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190404|NCT01410227|O1|Outcome|Overall Study Arm|
190405|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190406|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190407|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190408|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190409|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190410|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190411|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190412|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190413|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190414|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190415|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190517|NCT01409837|E2|Reported Event|Events Reported During Treatment With Placebo|All the events reported by patients in either group A or group B while receiving the Sugar Pill.
190416|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190417|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190418|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190419|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190420|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190421|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190422|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190423|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190424|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190425|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190426|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190427|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190428|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
190429|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total of participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
192040|NCT01402128|E2|Reported Event|Placebo|Placebo for 12 weeks
190430|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
190431|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
190432|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
190433|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
190434|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
190435|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
190436|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
190437|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
190438|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
190439|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
190440|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
190441|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
190442|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
190443|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
190444|NCT01410227|O1|Outcome|Full Analysis Set|Comprises of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
190445|NCT01410227|E1|Reported Event|Safety Analysis Set|Comprises of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
190446|NCT01410110|B3|Baseline|Total|Total of all reporting groups
190447|NCT01410110|B2|Baseline|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190448|NCT01410110|B1|Baseline|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190449|NCT01410110|P2|Participant Flow|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190450|NCT01410110|P1|Participant Flow|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190451|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190452|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190453|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190454|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190455|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190456|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190457|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190518|NCT01409837|E1|Reported Event|Events Reported During Treatment With Lisinopril|All the events reported by patients in either group A or group B while receiving Lisinopril.
190519|NCT01409707|B4|Baseline|Total|Total of all reporting groups
190458|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190459|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190460|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190461|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190462|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190463|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190464|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190465|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190466|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190467|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190468|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190469|NCT01410110|E2|Reported Event|Work Therapy Only|"Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy"
190470|NCT01410110|E1|Reported Event|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.
Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.
Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
190471|NCT01409993|B3|Baseline|Total|Total of all reporting groups
190472|NCT01409993|B2|Baseline|Placebo|"matching placebo p.o. tid
Administration of placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil or placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190473|NCT01409993|B1|Baseline|Sildenafil|"sildenafil 25 mg p.o. tid
Administration of sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190474|NCT01409993|P4|Participant Flow|Placebo Aim 2|Administration of Placebo: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.
190475|NCT01409993|P3|Participant Flow|Sildenafil Aim 2|Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive sildenafil for 3 months. Another euglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test.
190476|NCT01409993|P2|Participant Flow|Placebo Aim 1|"matching placebo p.o. tid
Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190477|NCT01409993|P1|Participant Flow|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid
Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190478|NCT01409993|O4|Outcome|Placebo Aim 2|"matching placebo p.o. tid
Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190479|NCT01409993|O3|Outcome|Sildenafil Aim 2|"sildenafil 25 mg p.o. tid
Sildenafil: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190480|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid
Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190481|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid
Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190482|NCT01409993|O4|Outcome|Placebo Aim 2|"matching placebo p.o. tid
Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190483|NCT01409993|O3|Outcome|Sildenafil Aim 2|"sildenafil 25 mg p.o. tid
Sildenafil: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190484|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid
Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil or placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190485|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid
Administration of Sildenafil : Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190486|NCT01409993|O2|Outcome|Placebo Aim 2|"matching placebo p.o. tid
Administration of Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190487|NCT01409993|O1|Outcome|Sildenafil Aim 2|"sildenafil 25 mg p.o. tid
Administration of Sildenafil : Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190488|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid
Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190489|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid
Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190490|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid
Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190491|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid
Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190492|NCT01409993|E2|Reported Event|Placebo - Aims 1 and 2|"matching placebo p.o. tid
Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190493|NCT01409993|E1|Reported Event|Sildenafil - Aims 1 and 2|"sildenafil 25 mg p.o. tid
Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
190494|NCT01409837|B3|Baseline|Total|Total of all reporting groups
190495|NCT01409837|B2|Baseline|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
190496|NCT01409837|B1|Baseline|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
190497|NCT01409837|P2|Participant Flow|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill taken once daily. Then crossed over to Lisinopril 2.5 mg taken once a day.
190498|NCT01409837|P1|Participant Flow|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril 2.5 mg taken once a day. Then crossed over to Sugar Pill taken also once a day. The Lisinopril and the Sugar Pill were made indistinguishable in appearance.
190499|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
190500|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
190501|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
190502|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
190503|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
190504|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
190505|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
190506|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
190507|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
190508|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
190509|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, then crossed over to Lisinopril
190510|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, then crossed over to Sugar Pill
190511|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, then crossed over to Lisinopril
190512|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, then crossed over to Sugar Pill
190513|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
190514|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
190515|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
190516|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
190520|NCT01409707|B3|Baseline|Motivational Enhancement + Trauma-focused Exposure Therapy|A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting the trauma-focused exposure therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
190521|NCT01409707|B2|Baseline|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
190522|NCT01409707|B1|Baseline|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
190523|NCT01409707|P3|Participant Flow|Motivational Enhancement + Trauma-focused Exposure Therapy|A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting exposure therapy. Exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for exposure therapy, and were taught breathing retraining as a method to manage arousal associated with posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided.
190524|NCT01409707|P2|Participant Flow|Trauma-focused Exposure Therapy|Trauma-focused exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for trauma-focused exposure therapy, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
190525|NCT01409707|P1|Participant Flow|Healthy Lifestyles Sessions|Healthy lifestyles sessions is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
190526|NCT01409707|O3|Outcome|Motivational Enhancement + Trauma-focused Exposure Therapy|One 90 min. motivational enhancement therapy session was provided prior to beginning trauma focused therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
190527|NCT01409707|O2|Outcome|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
190528|NCT01409707|O1|Outcome|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
190529|NCT01409707|O3|Outcome|Motivational Enhancement + Trauma-focused Exposure Therapy|One 90 min. motivational enhancement therapy session was provided prior to beginning trauma focused therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
190530|NCT01409707|O2|Outcome|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
190531|NCT01409707|O1|Outcome|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
190532|NCT01409707|E2|Reported Event|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
190533|NCT01409707|E1|Reported Event|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
190534|NCT01409564|B3|Baseline|Total|Total of all reporting groups
190535|NCT01409564|B2|Baseline|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
190536|NCT01409564|B1|Baseline|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
190568|NCT01409382|O2|Outcome|Standard Follow-up|Prenatal care will proceed according to the routine.
190537|NCT01409564|P2|Participant Flow|Placebo|Placebo group includes dementia patients receiving donepezil with placebo. All the patients were randomly assigned as placebo group and received 10 mg of Donepezil along with the same dose of sugar pill as normal cilostazol. All the clinical assessments and medications were doubly blinded. All the medications were orally administered.
190538|NCT01409564|P1|Participant Flow|Cilostazol|Cilostazol group includes dementia patients receiving donepezil with cilostazol augmentation. All the randomly assigned AD patients in cilostazol group received 10 mg of Donepezil along with 200 mg of cilostazol per a day, doubly blinded. All the medications were orally administered. For the initial two weeks, patients only received 100 mg of cilstazol per a day to minimize the instabilities. Afterwards, for 22 weeks, patients received 200 mg of cilostazol.
190539|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
190540|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
190541|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
190542|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
190543|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
190544|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
190545|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
190546|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
190547|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
190548|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
190549|NCT01409564|O4|Outcome|Placebo, 24-week|Placebo group means dementia patients group receiving donepezil with placebo after 24 weeks.
190550|NCT01409564|O3|Outcome|Placebo, Baseline|Placebo group means dementia patients group receiving donepezil with placebo at the baseline.
190551|NCT01409564|O2|Outcome|Cilostazol, 24-week|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation after 24 weeks.
190552|NCT01409564|O1|Outcome|Cilostazol, Baseline|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation at the baseline.
190553|NCT01409564|E2|Reported Event|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
190554|NCT01409564|E1|Reported Event|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
190555|NCT01409434|B1|Baseline|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
190556|NCT01409434|P1|Participant Flow|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
190557|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
190558|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
190559|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
190560|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
190561|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
190562|NCT01409434|E1|Reported Event|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
190563|NCT01409382|B3|Baseline|Total|Total of all reporting groups
190564|NCT01409382|B2|Baseline|Standard Follow-up|Prenatal care will proceed according to the routine
190565|NCT01409382|B1|Baseline|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
190566|NCT01409382|P2|Participant Flow|Standard Follow-up|Prenatal care will proceed according to the routine. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
190567|NCT01409382|P1|Participant Flow|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet. Patients assigned to the intervention protocol will be instructed to walk briskly for at least 40 minutes seven days a week, to avoid high-carbohydrate meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
190571|NCT01409382|O1|Outcome|Neonates Born to Mothers Assigned to Protocol Walking+Diet|Neonates with hypoglycemia (blood glucose levels ≤ 40 mg/dL) at 1, 2 or 4 hours after birth
190572|NCT01409382|O2|Outcome|Standard Follow-up|Prenatal care will proceed according to the routine.
190573|NCT01409382|O1|Outcome|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
190574|NCT01409382|E4|Reported Event|Lifestyle Counseling (Babies)|Exercise plus a carbohydrate-controlled diet.
190575|NCT01409382|E3|Reported Event|Standard Follow-up (Babies)|Prenatal care will proceed according to the routine.
190576|NCT01409382|E2|Reported Event|Lifestyle Counseling (Mothers)|Exercise plus a carbohydrate-controlled diet.
190577|NCT01409382|E1|Reported Event|Standard Follow-up (Mothers)|Prenatal care will proceed according to the routine.
190578|NCT01409291|B3|Baseline|Total|Total of all reporting groups
190579|NCT01409291|B2|Baseline|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
190580|NCT01409291|B1|Baseline|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
190581|NCT01409291|P2|Participant Flow|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
190582|NCT01409291|P1|Participant Flow|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
190583|NCT01409291|O2|Outcome|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
190584|NCT01409291|O1|Outcome|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
190585|NCT01409291|O2|Outcome|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
190586|NCT01409291|O1|Outcome|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
190587|NCT01409291|E2|Reported Event|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
190588|NCT01409291|E1|Reported Event|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
190589|NCT01409239|B3|Baseline|Total|Total of all reporting groups
190590|NCT01409239|B2|Baseline|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
190591|NCT01409239|B1|Baseline|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
190592|NCT01409239|P2|Participant Flow|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
190593|NCT01409239|P1|Participant Flow|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
190594|NCT01409239|O2|Outcome|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
190595|NCT01409239|O1|Outcome|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
190596|NCT01409239|E2|Reported Event|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
190597|NCT01409239|E1|Reported Event|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
190598|NCT01409213|B1|Baseline|All Enrolled Participants|Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline.
190599|NCT01409213|P1|Participant Flow|All Enrolled Participants|
190600|NCT01409213|O1|Outcome|All Enrolled Participants|All enrolled participants with available data.
190601|NCT01409213|O1|Outcome|All Enrolled Participants|All enrolled participants with available data.
190602|NCT01409213|E1|Reported Event|All Enrolled Participants|
190603|NCT01409096|B3|Baseline|Total|Total of all reporting groups
190604|NCT01409096|B2|Baseline|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance."
190605|NCT01409096|B1|Baseline|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
190606|NCT01409096|P2|Participant Flow|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance."
190607|NCT01409096|P1|Participant Flow|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
190608|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance."
190609|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
190610|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance."
190611|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
190612|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance."
190613|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
190614|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance."
190615|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
190616|NCT01409096|E2|Reported Event|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance."
190617|NCT01409096|E1|Reported Event|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
190618|NCT01408992|B1|Baseline|Community People|The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. A total of 551 subjects were required to obtain an 80% sensitivity rate for the original test, at a 95% confidence level, with 80% power, and a 7% margin of error. Considering 22.7% as the estimated prevalence of hearing loss [Prasansuk, 2000] and a 10% drop out rate, the total number of subjects needed was 606. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older
190619|NCT01408992|P1|Participant Flow|Community People|The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. This district comprises 114 villages and has a population of 24,201 inhabitants. Of these, 13,001 inhabitants lived in municipal areas, whereas the rest lived in non-municipal areas. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older than 18 years, could read or understand the Thai language, and wanted to participate, were recruited. Those who had aphasia, severe mental disability, or other conditions that precluded audiometry were excluded.
190620|NCT01408992|O1|Outcome|Hearing Loss|The severity of hearing loss was defined by the pure tone average air-conduction threshold at the speech frequencies of the better hearing ears, according to the ASHA criteria. Normal hearing means PTA of less than or equal 25 dB. Mild hearing loss means PTA of 26-40 dB. Moderate hearing loss means PTA of 41-55 dB. Moderately severe hearing loss means PTA of 56-74 dB. Severe hearing loss means PTA of 75-90 dB. Profound hearing loss means PTA > 90 dB.
190621|NCT01408992|O1|Outcome|FMHT|"FMHT Score is the sum of value of the answers for each question. If the subject answers never, it will be scored as 0, occasionally will be 1, half the time will be 2, and almost always will be 3."
190622|NCT01408992|O7|Outcome|Mixed Hearing Loss|Air and bone conduction threshold are more than 25 dB with air-bone gap
190623|NCT01408992|O6|Outcome|Sensorineural Hearing Loss|Air and bone conduction thresholds are more than 25 dB
190624|NCT01408992|O5|Outcome|Conductive Hearing Loss|Air-bone gap and bone conduction thresholds are lower than 25 dB
190625|NCT01408992|O4|Outcome|Chronic Otitis Media|Tympanic membrane perforation with or without ear discharge
190626|NCT01408992|O3|Outcome|Otitis Media With Effusion|Fluid in middle ear, whether serous, mucoid, mucous, or pus
190627|NCT01408992|O2|Outcome|Ear Wax|Impacted cerumen
190628|NCT01408992|O1|Outcome|Normal Ears and Hearing|Normal ear examination and normal hearing
190698|NCT01408719|B1|Baseline|Sequence 1|3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
190629|NCT01408992|E1|Reported Event|Community People|All people who live in the Phu Wieng district in Khon Kaen Province was chosen as a representative of community people in Thailand.
190630|NCT01408914|B4|Baseline|Total|Total of all reporting groups
190631|NCT01408914|B3|Baseline|20 mg/kg|20 mg/kg RIF
190632|NCT01408914|B2|Baseline|15 mg/kg|15 mg/kg RIF
190633|NCT01408914|B1|Baseline|10 mg/kg|10 mg/kg RIF
190634|NCT01408914|P3|Participant Flow|20 mg/kg|20 mg/kg RIF
190635|NCT01408914|P2|Participant Flow|15 mg/kg|15 mg/kg RIF
190636|NCT01408914|P1|Participant Flow|10 mg/kg|10 mg/kg RIF
190637|NCT01408914|O3|Outcome|20 mg/kg|20 mg/kg RIF
190638|NCT01408914|O2|Outcome|15 mg/kg|15 mg/kg RIF
190639|NCT01408914|O1|Outcome|10 mg/kg|10 mg/kg RIF
190640|NCT01408914|O3|Outcome|20 mg/kg|20 mg/kg RIF
190641|NCT01408914|O2|Outcome|15 mg/kg|15 mg/kg RIF
190642|NCT01408914|O1|Outcome|10 mg/kg|10 mg/kg RIF
190643|NCT01408914|O3|Outcome|20 mg/kg|20 mg/kg RIF
190644|NCT01408914|O2|Outcome|15 mg/kg|15 mg/kg RIF
190645|NCT01408914|O1|Outcome|10 mg/kg|10 mg/kg RIF
190646|NCT01408914|E3|Reported Event|20 mg/kg|20 mg/kg RIF
190647|NCT01408914|E2|Reported Event|15 mg/kg|15 mg/kg RIF
190648|NCT01408914|E1|Reported Event|10 mg/kg|10 mg/kg RIF
190649|NCT01408888|B1|Baseline|Entire Study Population|Participants who received at least one dose of study drug (LY2189265 or Sitagliptin).
190650|NCT01408888|P2|Participant Flow|Sitagliptin + LY2189265, LY2189265|"First Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).
Second Intervention Period: A single 1.5-mg SC injection of LY2189265 on Day 1 (Treatment 1).
There was a washout of at least 21 days between treatments."
190651|NCT01408888|P1|Participant Flow|LY2189265, Sitagliptin + LY2189265|"First Intervention Period: A single 1.5-milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 (Treatment 1).
Second Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).
There was a washout of at least 21 days between treatments."
190652|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
190653|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
190654|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
190655|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
190656|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
190657|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
190658|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
190659|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
190660|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
190661|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
190662|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
190663|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
190664|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
190665|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg of LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
190666|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
190667|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
190668|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
190669|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
190670|NCT01408888|E3|Reported Event|Sitagliptin + LY2189265|"Sitagliptin + LY2189265: 100-mg dose of sitagliptin administered orally, once daily from Day 5 to Day 18 of Treatment 2 in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 of Treatment 2.
Time Frame: Day 5 to end of Treatment 2"
190671|NCT01408888|E2|Reported Event|Sitagliptin|"Sitagliptin: 100-mg dose of sitagliptin, administered orally, once daily before the LY2189265 dose on Day 1 to Day 5 of Treatment 2.
Time Frame: Day 1 to Day 5 of Treatment 2"
190672|NCT01408888|E1|Reported Event|LY2189265|"LY2189265: a single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously on Day 1 of Treatment 1
Time frame: Treatment 1"
190673|NCT01408862|B1|Baseline|Controls|Platelets from healthy human subjects who were not taken any medication in the previous 10 days were studied. Blood samples (30 ml) were drawn with i) ACD-C (9:1, v/v) (7 mmol/L citric acid, 93 mmol/L citrate, 139 mmol/L dextrose, pH 6.4) for gene expression and western blot studies; ii) with 1% EDTA for flow cytometry and iii) with 3.8% sodium citrate for functional studies. Blood samples were centrifuged at 150 g for 10 min to obtain platelet-rich plasma (PRP).
190674|NCT01408862|P1|Participant Flow|Controls|"20 healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture
venous puncture: Blood for in vitro studies were drawn"
190675|NCT01408862|O1|Outcome|Controls|"Healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture
venous puncture: Blood for in vitro studies were drawn"
190676|NCT01408862|O1|Outcome|Controls|Flow cytometry studies In order to test the presence of GLP1 and GIP receptors on normal platelet membrane, indirect immunodetection was carried out in platelet samples from 20 normal donors.
190677|NCT01408862|E1|Reported Event|Controls|"Healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture
venous puncture: Blood for in vitro studies were drawn"
190678|NCT01408719|B21|Baseline|Total|Total of all reporting groups
190679|NCT01408719|B20|Baseline|Sequence 20|3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
190680|NCT01408719|B19|Baseline|Sequence 19|Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
190681|NCT01408719|B18|Baseline|Sequence 18|5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
190682|NCT01408719|B17|Baseline|Sequence 17|3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
190683|NCT01408719|B16|Baseline|Sequence 16|3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
190684|NCT01408719|B15|Baseline|Sequence 15|3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
190685|NCT01408719|B14|Baseline|Sequence 14|3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
190686|NCT01408719|B13|Baseline|Sequence 13|3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
190687|NCT01408719|B12|Baseline|Sequence 12|5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
190688|NCT01408719|B11|Baseline|Sequence 11|3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
190689|NCT01408719|B10|Baseline|Sequence 10|Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
190690|NCT01408719|B9|Baseline|Sequence 9|Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
190691|NCT01408719|B8|Baseline|Sequence 8|3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
190692|NCT01408719|B7|Baseline|Sequence 7|5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
190693|NCT01408719|B6|Baseline|Sequence 6|control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
190694|NCT01408719|B5|Baseline|Sequence 5|3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
190695|NCT01408719|B4|Baseline|Sequence 4|5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
192041|NCT01402128|E1|Reported Event|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
190699|NCT01408719|P20|Participant Flow|Sequence 20|3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
190700|NCT01408719|P19|Participant Flow|Sequence 19|Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
190701|NCT01408719|P18|Participant Flow|Sequence 18|5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
190702|NCT01408719|P17|Participant Flow|Sequence 17|3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
190703|NCT01408719|P16|Participant Flow|Sequence 16|3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
190704|NCT01408719|P15|Participant Flow|Sequence 15|3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
190705|NCT01408719|P14|Participant Flow|Sequence 14|3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
190706|NCT01408719|P13|Participant Flow|Sequence 13|3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
190707|NCT01408719|P12|Participant Flow|Sequence 12|5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
190708|NCT01408719|P11|Participant Flow|Sequence 11|3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
190709|NCT01408719|P10|Participant Flow|Sequence 10|Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
190710|NCT01408719|P9|Participant Flow|Sequence 9|Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
190711|NCT01408719|P8|Participant Flow|Sequence 8|3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
190712|NCT01408719|P7|Participant Flow|Sequence 7|5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
190713|NCT01408719|P6|Participant Flow|Sequence 6|control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
190714|NCT01408719|P5|Participant Flow|Sequence 5|3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
190715|NCT01408719|P4|Participant Flow|Sequence 4|5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
190716|NCT01408719|P3|Participant Flow|Sequence 3|3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
190717|NCT01408719|P2|Participant Flow|Sequence 2|Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
190718|NCT01408719|P1|Participant Flow|Sequence 1|3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
190719|NCT01408719|O4|Outcome|Control|"control diet containing negligible amount of beta glucan
3g HMW beta-glucan: 3 grams of high molecular weight beta-glucan"
190720|NCT01408719|O3|Outcome|3g LMW Beta Glucan|"3 grams of low molecular weight beta-glucan diet for 35 days
5g LMW beta-glucan: 5 grams beta-glucan"
190721|NCT01408719|O2|Outcome|3g HMW Beta Glucan|"3 gram high molecular weight barley beta-glucan diet for 35 days
3g LMW beta-glucan: 3grams beta-glucan"
190722|NCT01408719|O1|Outcome|5g LMW Beta Glucan|"5 gram low molecular weight barley beta-glucan diet for 35 days
Control: Minimal beta-glucan"
190723|NCT01408719|E4|Reported Event|5g LMW Beta-glucan|5 grams low molecular weight barley beta-glucan
190724|NCT01408719|E3|Reported Event|3g LMW Beta-glucan|3 grams low molecular weight barley beta-glucan
190725|NCT01408719|E2|Reported Event|3g HMW Beta-glucan|3 grams high molecular weight barley beta-glucan
190726|NCT01408719|E1|Reported Event|Control|Minimal barley and minimal beta-glucan
190727|NCT01408706|B3|Baseline|Total|Total of all reporting groups
190728|NCT01408706|B2|Baseline|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
190729|NCT01408706|B1|Baseline|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
190730|NCT01408706|P2|Participant Flow|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
190731|NCT01408706|P1|Participant Flow|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
190732|NCT01408706|O2|Outcome|Radiadyne Immobilizer Treatment Device|The Radiadyne Immobilizer Treatment Device is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy
190733|NCT01408706|O1|Outcome|Miller Enema Air Tip|The Miller enema air tip rectal balloon is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy.
190734|NCT01408706|O2|Outcome|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
190735|NCT01408706|O1|Outcome|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
190759|NCT01408537|O1|Outcome|GMT of NT on 28days After Vaccination|GMT of NT titer of subjects on 28 days after vaccination (excluded the subject who had NT titer > =10 before first vaccination).
190806|NCT01407575|O2|Outcome|Placebo|"matching placebo- sublingual- over the course of 8 weeks
Placebo: matched placebo"
190736|NCT01408706|O2|Outcome|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
190737|NCT01408706|O1|Outcome|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
190738|NCT01408706|E2|Reported Event|Radiadyne Immobilizer Treatment Device|"Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
190739|NCT01408706|E1|Reported Event|Miller Enema Air Tip|"Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy."
190740|NCT01408628|B1|Baseline|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
190741|NCT01408628|P1|Participant Flow|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
190742|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
190743|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
190744|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of ≤ 7.0% using an established treat-to-target algorithm.
190745|NCT01408628|E1|Reported Event|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
190746|NCT01408537|B1|Baseline|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
190747|NCT01408537|P1|Participant Flow|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
190748|NCT01408537|O1|Outcome|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
190749|NCT01408537|O8|Outcome|SAEs Entire the Study|SAEs which occured entire the study period were recorded.
190750|NCT01408537|O7|Outcome|Unsolicited AEs After Each Vaccination|unsolicited AEs after each vaccinations (3 doses). Episode of unsolicited AEs (excluded SAEs) were collected up to 28 days after each vaccination
190751|NCT01408537|O6|Outcome|Urticaria After Vaccination|Urticaria after each vaccinations (3 doses). Episode of Urticaria was collected up to 28 days after each vaccination.
190752|NCT01408537|O5|Outcome|Vomiting After Vaccination|Vomiting after each vaccinations (3 doses). Episode of vomiting was collected up to 28 days after each vaccination.
190753|NCT01408537|O4|Outcome|Poor Appetite After Vaccination|Poor appetite after each vaccinations (3 doses). Episode of poor appetite was collected up to 28 days after each vaccination.
190754|NCT01408537|O3|Outcome|Chills After Vaccination|Chills after each vaccinations (3 doses). Episode of chills was collected up to 28 days after each vaccination.
190755|NCT01408537|O2|Outcome|Local AE JEVAC After Vaccination|"Local Adverse event (tenderness, redness, ecchymosis, hematoma and swelling) after each vaccinations the first vaccination was on day of enrollment, the second dose was Day7 (+21day))
, Booster vaccine was on 1 year(+30days). Local AEs were collected up to 28 days after each vaccination."
190756|NCT01408537|O1|Outcome|Fever After Vaccination|Fever (Temp > =37.5 Axillary )after each vaccinations (3 doses). Episode of fever was collected up to 28 days after each vaccination.
190757|NCT01408537|O3|Outcome|GMT of NT Titer After Booster Vaccine|GMT of NT of subject at 28 days after booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
190758|NCT01408537|O2|Outcome|GMT of NT Before Booster Vaccine|GMT of NT of subject at 1 year before booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
190760|NCT01408537|O1|Outcome|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
190761|NCT01408537|E1|Reported Event|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
190762|NCT01408485|B1|Baseline|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter
IBI 1500T9 V1.43 RF Generator"
190763|NCT01408485|P1|Participant Flow|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter
IBI 1500T9 V1.43 RF Generator"
190764|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter
IBI 1500T9 V1.43 RF Generator"
190765|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter
IBI 1500T9 V1.43 RF Generator"
190766|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter
IBI 1500T9 V1.43 RF Generator"
190767|NCT01408485|E1|Reported Event|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter
IBI 1500T9 V1.43 RF Generator"
190768|NCT01408329|B3|Baseline|Total|Total of all reporting groups
190769|NCT01408329|B2|Baseline|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6096 meters
190770|NCT01408329|B1|Baseline|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
190771|NCT01408329|P2|Participant Flow|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6096 meters
190772|NCT01408329|P1|Participant Flow|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
190773|NCT01408329|O2|Outcome|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6097m
190774|NCT01408329|O1|Outcome|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
190775|NCT01408329|E2|Reported Event|Cyclic Hypoxic Group|Rapidly fluctuating simulated altitude up to 6097 meters
190776|NCT01408329|E1|Reported Event|Sham Group|Slowly fluctuating simulated altitude up to 607 meters.
190777|NCT01408303|B4|Baseline|Total|Total of all reporting groups
190778|NCT01408303|B3|Baseline|Placebo|"placebo, 1 g capsule
placebo : 4 x 1 g capsule daily for 6 weeks"
190779|NCT01408303|B2|Baseline|Epanova, 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
190780|NCT01408303|B1|Baseline|Epanova, 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
190781|NCT01408303|P3|Participant Flow|Olive Oil + Statin|"olive oil, 1 g capsule
olive oil: 4 x 1 g capsule daily for 6 weeks
prescribed statin"
190782|NCT01408303|P2|Participant Flow|Epanova, 4 g + Statin|"omega-3 carboxylic acids, 1 g capsule
omega-3 carboxylic acids: omega-3 carboxylic acids 4 x 1 g capsule daily for 6 weeks
prescribed statin"
190783|NCT01408303|P1|Participant Flow|Epanova, 2 g + Statin|"omega-3 carboxylic acids, 1 g capsule
omega-3 carboxylic acids + olive oil: omega-3 carboxylic acids 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks
prescribe statin"
190784|NCT01408303|O3|Outcome|Placebo|"placebo, 1 g capsule
placebo : 4 x 1 g capsule daily for 6 weeks"
190785|NCT01408303|O2|Outcome|Epanova 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
190786|NCT01408303|O1|Outcome|Epanova 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo: omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
190787|NCT01408303|E3|Reported Event|Placebo|"placebo, 1 g capsule
placebo : 4 x 1 g capsule daily for 6 weeks"
190788|NCT01408303|E2|Reported Event|Epanova, 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
190789|NCT01408303|E1|Reported Event|Epanova, 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
190790|NCT01408277|B3|Baseline|Total|Total of all reporting groups
190791|NCT01408277|B2|Baseline|Control|Standard Care
190792|NCT01408277|B1|Baseline|Santyl|Collagenase (SANTYL®) Ointment
190793|NCT01408277|P2|Participant Flow|Control|Standard Care
190794|NCT01408277|P1|Participant Flow|Santyl|Collagenase (SANTYL®) Ointment
190795|NCT01408277|O2|Outcome|Control|"Control = Standard Care
Standard Care is defined as the standard wound care protocol for chronic wounds used by each Investigator, in their clinic (e.g., wet-to-dry, compression, sharp debridement, etc.)."
190796|NCT01408277|O1|Outcome|Santyl®|Collagenase (Santyl®) Ointment
190797|NCT01408277|E2|Reported Event|Control|Standard Care
190798|NCT01408277|E1|Reported Event|Santyl|Collagense (Santyl®) Ointment
190799|NCT01407575|B3|Baseline|Total|Total of all reporting groups
190800|NCT01407575|B2|Baseline|Placebo|Placebo: matched placebo
190801|NCT01407575|B1|Baseline|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
190802|NCT01407575|P2|Participant Flow|Placebo|Placebo: matched placebo
190803|NCT01407575|P1|Participant Flow|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
190804|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
190805|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
190807|NCT01407575|O1|Outcome|Buprenorphine|"0.2 to 1.6mg of buprenorphine sublingual over the course of 8 weeks
Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)"
190808|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
190809|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
190810|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
190811|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
190812|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
190813|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
190814|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
190815|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
190816|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
190817|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
190818|NCT01407575|E2|Reported Event|Placebo|Placebo: matched placebo
190819|NCT01407575|E1|Reported Event|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
190820|NCT01407523|B1|Baseline|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Levetiracetam :
Formulation: concentrate for solution for infusion
Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
Frequency: twice daily"
190821|NCT01407523|P1|Participant Flow|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Levetiracetam :
Formulation: concentrate for solution for infusion
Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
Frequency: twice daily"
190822|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Levetiracetam :
Formulation: concentrate for solution for infusion
Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
Frequency: twice daily"
190823|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Levetiracetam :
Formulation: concentrate for solution for infusion
Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
Frequency: twice daily"
190824|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Levetiracetam :
Formulation: concentrate for solution for infusion
Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
Frequency: twice daily"
190825|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Levetiracetam :
Formulation: concentrate for solution for infusion
Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
Frequency: twice daily"
190826|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Levetiracetam :
Formulation: concentrate for solution for infusion
Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
Frequency: twice daily"
190827|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Levetiracetam :
Formulation: concentrate for solution for infusion
Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
Frequency: twice daily"
190828|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Levetiracetam :
Formulation: concentrate for solution for infusion
Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
Frequency: twice daily"
190829|NCT01407523|E1|Reported Event|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Levetiracetam :
Formulation: concentrate for solution for infusion
Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
Frequency: twice daily"
190830|NCT01407354|B1|Baseline|All Study Participants|Baseline data reflects all participants who received both aquatic exercise and lokomat training during the study.
190831|NCT01407354|P2|Participant Flow|Aquatic Therapy First Then Lokomat Intervention|"Aquatic exercise therapy
Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session, participants received lokomat intervention after aquatic exercise"
190832|NCT01407354|P1|Participant Flow|Lokomat First Then Aquatic Exercise|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training
Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session, participants received aquatic exercise after lokomat"
190833|NCT01407354|O2|Outcome|Aquatic Therapy|"Aquatic exercise therapy
Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
190834|NCT01407354|O1|Outcome|Lokomat|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training
Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session,"
190835|NCT01407354|O2|Outcome|Aquatic Therapy|"Aquatic exercise therapy
Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
190836|NCT01407354|O1|Outcome|Lokomat Training|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training
Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session"
190837|NCT01407354|E2|Reported Event|Aquatic Therapy|"Aquatic exercise therapy
Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
191013|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
190838|NCT01407354|E1|Reported Event|Lokomat Training|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training
Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session"
190839|NCT01407276|B9|Baseline|Total|Total of all reporting groups
190840|NCT01407276|B8|Baseline|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
190841|NCT01407276|B7|Baseline|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
190842|NCT01407276|B6|Baseline|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190843|NCT01407276|B5|Baseline|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190844|NCT01407276|B4|Baseline|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190845|NCT01407276|B3|Baseline|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190846|NCT01407276|B2|Baseline|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190847|NCT01407276|B1|Baseline|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190848|NCT01407276|P8|Participant Flow|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
190849|NCT01407276|P7|Participant Flow|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
190850|NCT01407276|P6|Participant Flow|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190851|NCT01407276|P5|Participant Flow|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190852|NCT01407276|P4|Participant Flow|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190853|NCT01407276|P3|Participant Flow|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190854|NCT01407276|P2|Participant Flow|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190855|NCT01407276|P1|Participant Flow|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190856|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
190857|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Periods 1 and 2|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G.
190858|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190859|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190860|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190861|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190862|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190863|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190864|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
190865|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Periods 1 and 2|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G.
190866|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190867|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190868|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190869|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190870|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190871|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190967|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190872|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
190873|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
190874|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
190875|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
190876|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190877|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190878|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190879|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190880|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190881|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190882|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
190883|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
190884|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
190885|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
190886|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190887|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190888|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190889|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190890|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190891|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190892|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190893|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190894|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190895|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190896|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190897|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190898|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190899|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190900|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190901|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190902|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190903|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
191011|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
190904|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190905|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190906|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190907|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190908|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190909|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190910|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
190911|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
190912|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
190913|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
190914|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190915|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190916|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190917|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190918|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190919|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190920|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from the study was not included.
190921|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
190922|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
190923|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
190924|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190925|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190926|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190927|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190928|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190929|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190930|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
190931|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
190932|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
190933|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
190934|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190935|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190936|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190937|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190938|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190939|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190940|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
190941|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
190942|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
190943|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
190944|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190945|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190946|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190947|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190948|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190949|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190950|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
190951|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
190952|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
190953|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
190954|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190955|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190956|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190957|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190958|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190959|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190960|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
190961|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
190962|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
190963|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
190964|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190965|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190966|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
191012|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
190968|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190969|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190970|NCT01407276|E8|Reported Event|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
190971|NCT01407276|E7|Reported Event|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
190972|NCT01407276|E6|Reported Event|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
190973|NCT01407276|E5|Reported Event|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
190974|NCT01407276|E4|Reported Event|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
190975|NCT01407276|E3|Reported Event|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
190976|NCT01407276|E2|Reported Event|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
190977|NCT01407276|E1|Reported Event|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
190978|NCT01407068|B1|Baseline|AA4500|"AA4500 collagenase clostridium histolyticum
AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
190979|NCT01407068|P1|Participant Flow|AA4500|"AA4500 collagenase clostridium histolyticum
AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
190980|NCT01407068|O2|Outcome|AA4500 PIP|"AA4500 collagenase clostridium histolyticum
AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the interphalangeal (PIP) joint cord"
190981|NCT01407068|O1|Outcome|AA4500 MP|"AA4500 collagenase clostridium histolyticum
AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the metacarpophalangeal (MP) joint cord"
190982|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum
AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
190983|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum
AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
190984|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum
AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
190985|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum
AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
190986|NCT01407068|E1|Reported Event|AA4500|"AA4500 collagenase clostridium histolyticum
AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
190987|NCT01406990|B1|Baseline|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
190988|NCT01406990|P1|Participant Flow|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
190989|NCT01406990|O1|Outcome|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
190990|NCT01406990|E1|Reported Event|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
190991|NCT01406938|B3|Baseline|Total|Total of all reporting groups
190992|NCT01406938|B2|Baseline|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
190993|NCT01406938|B1|Baseline|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
190994|NCT01406938|P6|Participant Flow|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
190995|NCT01406938|P5|Participant Flow|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
190996|NCT01406938|P4|Participant Flow|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
190997|NCT01406938|P3|Participant Flow|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
190998|NCT01406938|P2|Participant Flow|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
190999|NCT01406938|P1|Participant Flow|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191000|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191001|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191002|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191003|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191004|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191005|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191006|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191007|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191008|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191009|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191010|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
192042|NCT01402115|B3|Baseline|Total|Total of all reporting groups
191015|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191016|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191017|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191018|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191019|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191020|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191021|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191022|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191023|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191024|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191025|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191026|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191027|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191028|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191029|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191030|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191031|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191032|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191033|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191034|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191035|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191036|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191037|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191038|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191039|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191040|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191041|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191042|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191043|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191044|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191045|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191046|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191047|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191048|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191049|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191050|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191051|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191052|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191053|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191054|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191055|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191056|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191057|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191058|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191059|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191060|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191061|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191062|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191063|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191064|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191065|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191066|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191067|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191069|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191070|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191071|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191072|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191073|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191074|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191075|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191076|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191077|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191078|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191079|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191080|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191081|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191082|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191083|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191084|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191085|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191086|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191087|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191088|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191089|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191090|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191091|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191092|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191093|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191094|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191095|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191096|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
191097|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
191098|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
191099|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
191100|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
191101|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
191102|NCT01406938|E12|Reported Event|FOLLOW UP-AIN457 300 mg SoR|FOLLOW UP-AIN457 300 mg SoR
191103|NCT01406938|E11|Reported Event|FOLLOW UP-AIN457 150 mg SoR|FOLLOW UP-AIN457 150 mg SoR
191104|NCT01406938|E10|Reported Event|FOLLOW UP-AIN457 300 mg|FOLLOW UP-AIN457 300 mg
191105|NCT01406938|E9|Reported Event|FOLLOW UP-AIN457 150 mg|FOLLOW UP-AIN457 150 mg
191106|NCT01406938|E8|Reported Event|FOLLOW UP-AIN457 300mg IPO|FOLLOW UP-AIN457 300mg IPO
191107|NCT01406938|E7|Reported Event|FOLLOW UP-AIN457 150mg IPO|FOLLOW UP-AIN457 150mg IPO
191108|NCT01406938|E6|Reported Event|ENTIRE-AIN457 300 mg SoR|ENTIRE-AIN457 300 mg SoR
191109|NCT01406938|E5|Reported Event|ENTIRE-AIN457 150 mg SoR|ENTIRE-AIN457 150 mg SoR
191110|NCT01406938|E4|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
191111|NCT01406938|E3|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
191112|NCT01406938|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
191113|NCT01406938|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
191114|NCT01406795|B1|Baseline|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191115|NCT01406795|P1|Participant Flow|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191116|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191205|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
192043|NCT01402115|B2|Baseline|Placebo|Placebo 15mg for 12 weeks
191117|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191118|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191119|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191120|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191121|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191122|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191123|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191124|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191125|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191126|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191127|NCT01406795|E1|Reported Event|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
191128|NCT01406574|B1|Baseline|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
191129|NCT01406574|P4|Participant Flow|OPB-31121: 400mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
191130|NCT01406574|P3|Participant Flow|OPB-31121: 200mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
191131|NCT01406574|P2|Participant Flow|OPB-31121: 100mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
191132|NCT01406574|P1|Participant Flow|OPB-31121: 50mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
191133|NCT01406574|O1|Outcome|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
191134|NCT01406574|O4|Outcome|OPB-31121: 400 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
191135|NCT01406574|O3|Outcome|OPB-31121: 200 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
191136|NCT01406574|O2|Outcome|OPB-31121: 100 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
191137|NCT01406574|O1|Outcome|OPB-31121: 50 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
191138|NCT01406574|O1|Outcome|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
191139|NCT01406574|E4|Reported Event|OPB-31121: 400 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
191140|NCT01406574|E3|Reported Event|OPB-31121: 200 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
191141|NCT01406574|E2|Reported Event|OPB-31121: 100 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
191142|NCT01406574|E1|Reported Event|OPB-31121: 50 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
191143|NCT01406223|B5|Baseline|Total|Total of all reporting groups
191144|NCT01406223|B4|Baseline|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
Placebo patch"
191206|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191207|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191145|NCT01406223|B3|Baseline|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.
Varenicline
Bupropion
Nicotine patches
Placebo patch"
191146|NCT01406223|B2|Baseline|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion"
191147|NCT01406223|B1|Baseline|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.
Varenicline
Nicotine patches
Placebo bupropion
Placebo patch"
191148|NCT01406223|P4|Participant Flow|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
Placebo patch"
191149|NCT01406223|P3|Participant Flow|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.
Varenicline
Bupropion
Nicotine patches
Placebo patch"
191150|NCT01406223|P2|Participant Flow|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion"
191151|NCT01406223|P1|Participant Flow|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.
Varenicline
Nicotine patches
Placebo bupropion
Placebo patch"
191152|NCT01406223|O4|Outcome|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
Placebo patch"
191153|NCT01406223|O3|Outcome|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.
Varenicline
Bupropion
Nicotine patches
Placebo patch"
191154|NCT01406223|O2|Outcome|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion"
191155|NCT01406223|O1|Outcome|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.
Varenicline
Nicotine patches
Placebo bupropion
Placebo patch"
191156|NCT01406223|O4|Outcome|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
Placebo patch"
191157|NCT01406223|O3|Outcome|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.
Varenicline
Bupropion
Nicotine patches
Placebo patch"
191158|NCT01406223|O2|Outcome|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion"
191208|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191209|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191159|NCT01406223|O1|Outcome|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.
Varenicline
Nicotine patches
Placebo bupropion
Placebo patch"
191160|NCT01406223|E4|Reported Event|Post-quit NRT|"Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion
Placebo patch"
191161|NCT01406223|E3|Reported Event|Varenicline + Bupropion|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.
Varenicline
Bupropion
Nicotine patches
Placebo patch"
191162|NCT01406223|E2|Reported Event|NRT (Nicotine Patches Only)|"21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Nicotine patches
Placebo varenicline
Placebo bupropion"
191163|NCT01406223|E1|Reported Event|Varenicline|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.
Varenicline
Nicotine patches
Placebo bupropion
Placebo patch"
191164|NCT01406015|B3|Baseline|Total|Total of all reporting groups
191165|NCT01406015|B2|Baseline|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
191166|NCT01406015|B1|Baseline|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
191167|NCT01406015|P2|Participant Flow|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
191168|NCT01406015|P1|Participant Flow|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
191169|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
191170|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
191171|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
191172|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
191173|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
191174|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
191175|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
191176|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
191177|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
191178|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
191179|NCT01406015|E2|Reported Event|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
191180|NCT01406015|E1|Reported Event|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
191181|NCT01405950|B3|Baseline|Total|Total of all reporting groups
191182|NCT01405950|B2|Baseline|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
191183|NCT01405950|B1|Baseline|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
191184|NCT01405950|P4|Participant Flow|Dose Level 4|Zanaflex Capsules : 0.1 mg/kg
191185|NCT01405950|P3|Participant Flow|Dose Level 3|Zanaflex Capsules : 0.075 mg/kg
191186|NCT01405950|P2|Participant Flow|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
191187|NCT01405950|P1|Participant Flow|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
191188|NCT01405950|O4|Outcome|Dose Level 4|Zanaflex Capsules: 0.1 mg/kg
191189|NCT01405950|O3|Outcome|Dose Level 3|Zanaflex Capsules: 0.075 mg/kg
191190|NCT01405950|O2|Outcome|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
191191|NCT01405950|O1|Outcome|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
191192|NCT01405950|O4|Outcome|Dose Level 4|Zanaflex Capsules: 0.1 mg/kg
191193|NCT01405950|O3|Outcome|Dose Level 3|Zanaflex Capsules: 0.075 mg/kg
191194|NCT01405950|O2|Outcome|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
191195|NCT01405950|O1|Outcome|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
191196|NCT01405950|E2|Reported Event|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
191197|NCT01405950|E1|Reported Event|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
191198|NCT01405937|B3|Baseline|Total|Total of all reporting groups
191199|NCT01405937|B2|Baseline|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191200|NCT01405937|B1|Baseline|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191201|NCT01405937|P2|Participant Flow|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191202|NCT01405937|P1|Participant Flow|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191203|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191204|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191210|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191211|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191212|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191213|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191214|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191215|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191216|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191217|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191218|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191219|NCT01405937|E2|Reported Event|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191220|NCT01405937|E1|Reported Event|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
191221|NCT01405924|B1|Baseline|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
191222|NCT01405924|P1|Participant Flow|Fosaprepitant 150 mg|Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
191223|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
191224|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
191225|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
191226|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
191227|NCT01405924|O2|Outcome|Fosaprepitant 150 mg: CT Chemotherapy|Women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
191228|NCT01405924|O1|Outcome|Fosaprepitant 150 mg: AC-like Chemotherapy|Women with breast cancer receiving AC-like chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
191229|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
191230|NCT01405924|E1|Reported Event|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
191231|NCT01405898|B3|Baseline|Total|Total of all reporting groups
191232|NCT01405898|B2|Baseline|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
191233|NCT01405898|B1|Baseline|Beetroot Juice|Beetroot juice 4 weeks 250ml daily
191234|NCT01405898|P2|Participant Flow|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
191235|NCT01405898|P1|Participant Flow|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
191236|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
191237|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
191238|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
191239|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
191240|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
191241|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
191242|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
191243|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
191244|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
191245|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
191246|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
191247|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
191248|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
191249|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
191250|NCT01405898|E2|Reported Event|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
191251|NCT01405898|E1|Reported Event|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
191252|NCT01405820|B7|Baseline|Total|Total of all reporting groups
191253|NCT01405820|B6|Baseline|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
191254|NCT01405820|B5|Baseline|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
191255|NCT01405820|B4|Baseline|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
191256|NCT01405820|B3|Baseline|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
191257|NCT01405820|B2|Baseline|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
191258|NCT01405820|B1|Baseline|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
191259|NCT01405820|P6|Participant Flow|Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191260|NCT01405820|P5|Participant Flow|Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191261|NCT01405820|P4|Participant Flow|Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191262|NCT01405820|P3|Participant Flow|Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191263|NCT01405820|P2|Participant Flow|Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191264|NCT01405820|P1|Participant Flow|Natalizumab 300 mg Intravenous (IV) Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191265|NCT01405820|O6|Outcome|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
191266|NCT01405820|O5|Outcome|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
191267|NCT01405820|O4|Outcome|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
191268|NCT01405820|O3|Outcome|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
191269|NCT01405820|O2|Outcome|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
191270|NCT01405820|O1|Outcome|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
191271|NCT01405820|E12|Reported Event|Open-label Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191272|NCT01405820|E11|Reported Event|Open-label Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191273|NCT01405820|E10|Reported Event|Open-label Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191274|NCT01405820|E9|Reported Event|Open-label Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191275|NCT01405820|E8|Reported Event|Open-label Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191276|NCT01405820|E7|Reported Event|Open-label Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
191277|NCT01405820|E6|Reported Event|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
191278|NCT01405820|E5|Reported Event|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
191279|NCT01405820|E4|Reported Event|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
191280|NCT01405820|E3|Reported Event|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
191281|NCT01405820|E2|Reported Event|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
191282|NCT01405820|E1|Reported Event|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
191283|NCT01405794|B1|Baseline|All Participants|
191284|NCT01405794|P1|Participant Flow|All Study Participants|All participants were dosed with the placebo (14 days), then they all had a 72hr washout period. Last all participants were dosed with the 32ppm Oral Silver for (14 days).
191285|NCT01405794|O2|Outcome|32ppm Oral Silver|
191286|NCT01405794|O1|Outcome|Placebo|
191287|NCT01405794|O2|Outcome|32ppm Oral Silver|
191288|NCT01405794|O1|Outcome|Placebo|
191289|NCT01405794|O2|Outcome|32ppm Oral Silver|
191290|NCT01405794|O1|Outcome|Placebo|
191291|NCT01405794|O2|Outcome|32ppm Oral Silver|
191292|NCT01405794|O1|Outcome|Placebo|
191358|NCT01405768|B2|Baseline|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.
sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
191359|NCT01405768|B1|Baseline|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
191360|NCT01405768|P2|Participant Flow|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.
sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
191361|NCT01405768|P1|Participant Flow|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
191362|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.
sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
191363|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
191364|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.
sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
191365|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
191366|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.
sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
191367|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
191368|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.
sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
191369|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
191370|NCT01405768|E2|Reported Event|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.
sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
191371|NCT01405768|E1|Reported Event|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
191372|NCT01405742|B1|Baseline|Severe Hemophilia A|Subjects will be randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period.
191373|NCT01405742|P2|Participant Flow|Thrice-Weekly Then Once-Weekly FVIII|Subjects randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period. Group 1, will receive Arm A for the first 26 weeks, and Arm B for the last 26 weeks. Group 2, will receive Arm B for the first 26 weeks and Arm A for the last 26 weeks.
191374|NCT01405742|P1|Participant Flow|Once-Weekly Then Thrice-Weekly FVIII|Subjects randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period. Group 1, will receive Arm A for the first 26 weeks, and Arm B for the last 26 weeks. Group 2, will receive Arm B for the first 26 weeks and Arm A for the last 26 weeks.
191375|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
191376|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
191377|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
191378|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
191379|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
191380|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
191381|NCT01405742|E2|Reported Event|Arm B Thrice-weekly F.VIII at 40 IU/kg|Subjects will be randomized to receive thrice-weekly F.VIII at 40 IU/kg for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm (once-weekly) for the last 26 weeks, following a 72 hour washout period.
191382|NCT01405742|E1|Reported Event|Arm A Once-weekly F.VIII at 40 IU/kg|Subjects in Arm A will be randomized to receive either once-weekly F.VIII at 40 IU/kg for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm (thrice-weekly) for the last 26 weeks, following a 72 hour washout period.
191383|NCT01405560|B1|Baseline|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
191384|NCT01405560|P1|Participant Flow|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
191385|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
191386|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
191387|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
191388|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
191389|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
191390|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
191391|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
191392|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
191393|NCT01405560|E1|Reported Event|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
191394|NCT01405508|B5|Baseline|Total Title|
191395|NCT01405508|B4|Baseline|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191396|NCT01405508|B3|Baseline|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
191397|NCT01405508|B2|Baseline|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191398|NCT01405508|B1|Baseline|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191399|NCT01405508|P4|Participant Flow|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191400|NCT01405508|P3|Participant Flow|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
191401|NCT01405508|P2|Participant Flow|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191498|NCT01404650|B1|Baseline|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
191537|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
191402|NCT01405508|P1|Participant Flow|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191403|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191404|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
191405|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191406|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191407|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191408|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
191409|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191410|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191411|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191412|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
191499|NCT01404650|P1|Participant Flow|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
191413|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191414|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191415|NCT01405508|E4|Reported Event|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191416|NCT01405508|E3|Reported Event|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
191417|NCT01405508|E2|Reported Event|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191418|NCT01405508|E1|Reported Event|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.
Down-Titration:
If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
191419|NCT01405469|B1|Baseline|POEM Patients|pilot study, first 16 patients who received POEM for treatment of achalasia
191420|NCT01405469|P1|Participant Flow|POEM Patients|pilot group of achalasia patients who received POEM Treatment: Endoscopic Myotomy of the Lower Esophageal Sphincter
191421|NCT01405469|O1|Outcome|POEM Patients|pilot study, first 16 patients who received POEM for treatment of achalasia
191422|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
191423|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
191424|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
191425|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
191426|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
191427|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
191428|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
191429|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
191430|NCT01405469|E1|Reported Event|POEM Patients|pilot group of achalasia patients who received POEM treatment
191431|NCT01405313|B1|Baseline|Modified ASV/Conventional ASV|Therapy used was Modified ASV and then Conventional ASV
191432|NCT01405313|P1|Participant Flow|First Modified ASV Then Conventional ASV|Patients receive Modified ASV algorithm as therapy for 1 night, then Conventional ASV for 1 night
191433|NCT01405313|O2|Outcome|Conventional ASV ODI|1 night of conventional ASV therapy with full polysomnography measurements
191434|NCT01405313|O1|Outcome|Modified ASV ODI|1 night of modified ASV therapy with full polysomnography measurements
191435|NCT01405313|O2|Outcome|Conventional ASV AHI|1 night of conventional ASV therapy with full polysomnography measurements
191436|NCT01405313|O1|Outcome|Modified ASV AHI|1 night of modified ASV therapy with full polysomnography measurements
191437|NCT01405313|E2|Reported Event|Modified ASV|Intervention was modified ASV therapy
191438|NCT01405313|E1|Reported Event|Conventional ASV|Intervention was conventional ASV therapy
191439|NCT01405027|B3|Baseline|Total|Total of all reporting groups
191440|NCT01405027|B2|Baseline|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191500|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
191441|NCT01405027|B1|Baseline|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.
No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191442|NCT01405027|P2|Participant Flow|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191443|NCT01405027|P1|Participant Flow|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.
No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191444|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191445|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.
No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191446|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191447|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.
No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191448|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but without clinical trial experience with an HCV protease inhibitor received patient education and management skills training from Hepatology Centers of Educational Expertise (HCEEs) during four (4) educational interventions.
Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191449|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor. HCEE investigators provided patient education and management skills training during four (4) educational interventions to Community Site investigators.
Patient education and management skills training: Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191450|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191451|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.
No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191452|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191501|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
191453|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.
No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191454|NCT01405027|E2|Reported Event|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191455|NCT01405027|E1|Reported Event|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.
No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
191456|NCT01404988|B4|Baseline|Total|Total of all reporting groups
191457|NCT01404988|B3|Baseline|Attention Placebo Intervention (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
191458|NCT01404988|B2|Baseline|Behavioral and Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
191459|NCT01404988|B1|Baseline|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.Behavioral Intervention will be delivered over the phone.
191460|NCT01404988|P3|Participant Flow|Attention Placebo Group (API) -|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
191461|NCT01404988|P2|Participant Flow|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
191462|NCT01404988|P1|Participant Flow|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement over the phone.
191463|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
191464|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
191465|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|"Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.
Behavioral Intervention will be delivered over the phone."
191466|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
191467|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
191468|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement. Behavioral Intervention will be delivered over the phone.
191469|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
191470|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
191471|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement. Behavioral Intervention will be delivered over the phone.
191472|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
191473|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
191474|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI) -|"Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.
Behavioral Intervention will be delivered over the phone."
191475|NCT01404988|E3|Reported Event|Arm 3|"Attention Placebo Group (API) - patients will receive non-tailored counseling on general health topics.
Telephone-Delivered API: Attention Placebo Intervention will be delivered over the phone"
191476|NCT01404988|E2|Reported Event|Arm 2|"Behavioral & Environmental Intervention (BEI) - Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.
Telephone-Delivered BEI: Behavioral and Environmental Intervention will be delivered over the phone"
191477|NCT01404988|E1|Reported Event|Arm 1|"Comprehensive behavioral intervention (BI) - Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.
Telephone-Delivered BI: Behavioral Intervention will be delivered over the phone."
191478|NCT01404936|B1|Baseline|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
191479|NCT01404936|P1|Participant Flow|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
191480|NCT01404936|O1|Outcome|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
191481|NCT01404936|E1|Reported Event|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
191482|NCT01404923|B3|Baseline|Total|Total of all reporting groups
191483|NCT01404923|B2|Baseline|Standard of Care|anti spasmodic agents: best standard of care prescriptions
191484|NCT01404923|B1|Baseline|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
191485|NCT01404923|P2|Participant Flow|Standard of Care|anti spasmodic agents: best standard of care prescriptions
191486|NCT01404923|P1|Participant Flow|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
191487|NCT01404923|O2|Outcome|Standard of Care|anti spasmodic agents: best standard of care prescriptions
191488|NCT01404923|O1|Outcome|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
191489|NCT01404923|O2|Outcome|Standard of Care|anti spasmodic agents: best standard of care prescriptions
191490|NCT01404923|O1|Outcome|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
191491|NCT01404923|E2|Reported Event|Standard of Care|anti spasmodic agents: best standard of care prescriptions
191492|NCT01404923|E1|Reported Event|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
191493|NCT01404832|B1|Baseline|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
191494|NCT01404832|P1|Participant Flow|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
191495|NCT01404832|O1|Outcome|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
191496|NCT01404832|O1|Outcome|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
191497|NCT01404832|E1|Reported Event|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
191604|NCT01404208|B2|Baseline|Sugar Pill|Placebo: Sugar pill
191502|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
191503|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
191504|NCT01404650|E1|Reported Event|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
191505|NCT01404611|B4|Baseline|Total|Total of all reporting groups
191506|NCT01404611|B3|Baseline|DF289 Plus DF277|"Ear drops
DF289 plus DF277: Ear drops"
191507|NCT01404611|B2|Baseline|DF277|"Ear drops
DF277: Ear drops"
191508|NCT01404611|B1|Baseline|DF289|"Ear drops
DF289: Ear drops"
191509|NCT01404611|P3|Participant Flow|DF289 Plus DF277|"Ear drops
DF289 plus DF277: Ear drops"
191510|NCT01404611|P2|Participant Flow|DF277|"Ear drops
DF277: Ear drops"
191511|NCT01404611|P1|Participant Flow|DF289|"Ear drops
DF289: Ear drops"
191512|NCT01404611|O3|Outcome|DF289 Plus DF277|"Ear drops
DF289 plus DF277: Ear drops"
191513|NCT01404611|O2|Outcome|DF277|"Ear drops
DF277: Ear drops"
191514|NCT01404611|O1|Outcome|DF289|"Ear drops
DF289: Ear drops"
191515|NCT01404611|E3|Reported Event|DF289 Plus DF277|"Ear drops
DF289 plus DF277: Ear drops"
191516|NCT01404611|E2|Reported Event|DF277|"Ear drops
DF277: Ear drops"
191517|NCT01404611|E1|Reported Event|DF289|"Ear drops
DF289: Ear drops"
191518|NCT01404572|B1|Baseline|All Treated|All participants tasted atazanavir, 15 mg/5 mL, in the current formulation and 2 new powder for oral use formulations in 3 different sequences
191519|NCT01404572|P3|Participant Flow|Treatment Sequence C, A, B|Participants in this sequence first tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose followed by at least a 45-minute washout period. Next, participants tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame.
191520|NCT01404572|P2|Participant Flow|Treatment Sequence B, C, A|Participants in this sequence first tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following at least a 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose. Following another 45-minute washout period, participants then tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame.
191521|NCT01404572|P1|Participant Flow|Treatment Sequence A, B, C|Participants in this sequence first tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame followed by at least a 45-minute washout period. Next, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose.
191522|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
191523|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
191524|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
191525|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
191526|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
191527|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
191528|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
191529|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
191530|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
191531|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C).
191532|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
191533|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
191534|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame+ 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
191535|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
191536|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
192044|NCT01402115|B1|Baseline|Polycan|Polycan 150mg for 12 weeks
191538|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted received atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
191539|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
191540|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
191541|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
191542|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
191543|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
191544|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
191545|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
191546|NCT01404572|E3|Reported Event|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
191547|NCT01404572|E2|Reported Event|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
191548|NCT01404572|E1|Reported Event|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A)
191549|NCT01404559|B3|Baseline|Total|Total of all reporting groups
191550|NCT01404559|B2|Baseline|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
No intervention. Control group.: There are no interventions in this observational arm of the study."
191551|NCT01404559|B1|Baseline|Transtibial Amputees|This arm included unilateral transtibial amputees who who were crossed over into 3 different prosthetic feet and assessed per intervention.
191552|NCT01404559|P4|Participant Flow|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
No intervention. Control group.: There are no interventions in this observational arm of the study."
191553|NCT01404559|P3|Participant Flow|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3(Endolite Elite Blade; 1 week) the prosthetic foot 1(Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week).
Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
191554|NCT01404559|P2|Participant Flow|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 3(Endolite Elite Blade; 1 week).
Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
191555|NCT01404559|P1|Participant Flow|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 3(Endolite Elite Blade;1 week).
Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
191556|NCT01404559|O4|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
No intervention. Control group.: There are no interventions in this observational arm of the study."
191557|NCT01404559|O3|Outcome|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3.
Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
191558|NCT01404559|O2|Outcome|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2.
Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
191559|NCT01404559|O1|Outcome|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1.
Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
191560|NCT01404559|O4|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
No intervention. Control group.: There are no interventions in this observational arm of the study."
191561|NCT01404559|O3|Outcome|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3.
Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
191562|NCT01404559|O2|Outcome|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2.
Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
191563|NCT01404559|O1|Outcome|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1.
Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
191564|NCT01404559|E1|Reported Event|Unilateral Transtibial Amputees|This arm/group included unilateral transtibial amputees who who were assessed three times. They were exposed to 3 different prosthetic feet interventions.
191565|NCT01404429|B3|Baseline|Total|Total of all reporting groups
191566|NCT01404429|B2|Baseline|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
191567|NCT01404429|B1|Baseline|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
191699|NCT01403805|O1|Outcome|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
191568|NCT01404429|P2|Participant Flow|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
191569|NCT01404429|P1|Participant Flow|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
191570|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
191571|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
191572|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
191573|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
191574|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
191575|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
191576|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
191577|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
191578|NCT01404429|E2|Reported Event|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
191579|NCT01404429|E1|Reported Event|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
191580|NCT01404260|B3|Baseline|Total|Total of all reporting groups
191581|NCT01404260|B2|Baseline|Arm B|gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
191582|NCT01404260|B1|Baseline|Arm A|"Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression
gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression"
191583|NCT01404260|P2|Participant Flow|Arm B: Gemcitabine + Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
191584|NCT01404260|P1|Participant Flow|Arm A: Gefitinib + Gemcitabine + Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression
191585|NCT01404260|O2|Outcome|Arm B: Gemcitabine +Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
191586|NCT01404260|O1|Outcome|Arm A: Gefitinib+Gemcitabine +Carboplatin|Arm A: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression
191587|NCT01404260|E2|Reported Event|Arm B|gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
191588|NCT01404260|E1|Reported Event|Arm A|"Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression
gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression"
191589|NCT01404234|B1|Baseline|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191590|NCT01404234|P1|Participant Flow|AZLI|Participants received three 28-day courses of Aztreonam for Inhalation Solution (AZLI), each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191591|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191592|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191593|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191594|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191595|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191596|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191597|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191598|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191599|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191600|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191601|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191602|NCT01404234|E1|Reported Event|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
191603|NCT01404208|B3|Baseline|Total|Total of all reporting groups
191605|NCT01404208|B1|Baseline|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
191606|NCT01404208|P2|Participant Flow|Sugar Pill|Placebo: Sugar pill
191607|NCT01404208|P1|Participant Flow|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
191608|NCT01404208|O2|Outcome|Sugar Pill|Placebo: Sugar pill
191609|NCT01404208|O1|Outcome|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
191610|NCT01404208|O2|Outcome|Sugar Pill|Placebo: Sugar pill
191611|NCT01404208|O1|Outcome|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
191612|NCT01404208|E2|Reported Event|Sugar Pill|Placebo: Sugar pill
191613|NCT01404208|E1|Reported Event|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
191614|NCT01404078|B3|Baseline|Total|Total of all reporting groups
191615|NCT01404078|B2|Baseline|Polycap Double Dose Plus Potassium|"Patients in this arm received one dose of low strength Polycap with potassium
Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
191616|NCT01404078|B1|Baseline|Polycap Single Dose|Patients in this arm received single dose of low strength Polycap only Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
191617|NCT01404078|P2|Participant Flow|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.
Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
191618|NCT01404078|P1|Participant Flow|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap
Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
191619|NCT01404078|O2|Outcome|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap
Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
191620|NCT01404078|O1|Outcome|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.
Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
191621|NCT01404078|E2|Reported Event|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap
Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
191622|NCT01404078|E1|Reported Event|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.
Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
191623|NCT01404039|B10|Baseline|Total|Total of all reporting groups
191624|NCT01404039|B9|Baseline|Mental Imagery (MI) - Control|
191625|NCT01404039|B8|Baseline|Mental Imagery (MI) - Real|
191626|NCT01404039|B7|Baseline|Observational Task (OT) - Control|
191627|NCT01404039|B6|Baseline|Observational Task (OT) - Real|
191628|NCT01404039|B5|Baseline|Somatosensory Learning (SL) Control Group|
191629|NCT01404039|B4|Baseline|Somatosensory Activation (S Activation)|
191630|NCT01404039|B3|Baseline|Somatosensory Learning (SL Blind)|
191631|NCT01404039|B2|Baseline|Somatosensory Learning (SL Sighted)|
191632|NCT01404039|B1|Baseline|Motor Learning (ML)|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
191633|NCT01404039|P13|Participant Flow|tDCS - Sham|This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS).
191634|NCT01404039|P12|Participant Flow|tDCS - Active|This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS).
191635|NCT01404039|P11|Participant Flow|Mental Imagery (MI) - Control Group|Control Group - Mental Imagery: Subjects will be asked to perform simple mental math calculations for 20 minutes. (ex. adding or subtracting a one digit number from a starting number (1+1=2; 2+1=3; 3+1= 4 and so on.)
191636|NCT01404039|P10|Participant Flow|Mental Imagery (MI)|Mental Imagery: Subjects will be seated in a chair and are asked to keep their arm and hand muscles fully relaxed. Then they will be asked to imagine repetitive movement of the left index finger to the left thumb for 5 minutes. Subjects then will be asked to imagine sequential movement of left finger to left thumb (thumb to 2nd, 3rd, 4th, 5th) for 5 minutes.
191637|NCT01404039|P9|Participant Flow|Observational Task (OT) - Control Group|Control Group -- Observational Task: Subjects in this group will be asked to watch a video of random geometric forms for the same duration of time as those in the observational task group.
191638|NCT01404039|P8|Participant Flow|Observational Task (OT)|Observational Task: Subjects in this group will watch a 10 second video of a right-handed person performing movements of their left index finger at a 1 Hz rate on a screen at a distance of 1 meter away. Subjects will be instructed to watch the video without any other specific instruction.
191746|NCT01403376|E2|Reported Event|Teriflunomide 14mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
191639|NCT01404039|P7|Participant Flow|Somatosensory Learning (SL) Control Group|"In this arm,the subjects will not receive any somatosensory input (SL control group).
There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
191640|NCT01404039|P6|Participant Flow|Somatosensory Activation (S Activation)|"In this arm, subject will receive simple sensory stimulation over their left index finger - Sactivation.
There will be an anticipated total of 10 subjects in this experimental arm.This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
191641|NCT01404039|P5|Participant Flow|Somatosensory Learning (SL Blind)|"In this arm, subject will perform sensory Learning without visual feedback - SL blind.
There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
191642|NCT01404039|P4|Participant Flow|Somatosensory Learning (SL Sighted)|"In this arm, subject will perform sensory Learning with visual feedback - SL sighted.
There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
191643|NCT01404039|P3|Participant Flow|Motor Learning (ML) MLcontrol Group/MLsighted/MLblind|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
191644|NCT01404039|P2|Participant Flow|Motor Learning (ML) MLblind/MLcontrol/MLsighted|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
191645|NCT01404039|P1|Participant Flow|Motor Learning - MLsighted/MLblind/MLcontrol|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
191646|NCT01404039|O11|Outcome|Mental Imagery (MI) - MI Control|
191647|NCT01404039|O10|Outcome|Mental Imagery (MI) - MI Real|
191648|NCT01404039|O9|Outcome|Observational Task (OT)- OT Control|
191649|NCT01404039|O8|Outcome|Observational Task (OT)- OT Real|
191650|NCT01404039|O7|Outcome|Somatosensory Learning (SL)-SL Control|
191651|NCT01404039|O6|Outcome|Somatosensory Learning (SL)-SL Activation|
191652|NCT01404039|O5|Outcome|Somatosensory Learning (SL)-SL Blind|
191653|NCT01404039|O4|Outcome|Somatosensory Learning (SL)- SL Sighted|
191654|NCT01404039|O3|Outcome|Motor Learning - ML Control|
191655|NCT01404039|O2|Outcome|Motor Learning -ML Blind|
191656|NCT01404039|O1|Outcome|Motor Learning (ML)-Sighted|
191657|NCT01404039|E11|Reported Event|Mental Imagery (MI) - Control|
191658|NCT01404039|E10|Reported Event|Mental Imagery (MI) - Real|
191659|NCT01404039|E9|Reported Event|Observational Task (OT) - Control|
191660|NCT01404039|E8|Reported Event|Observational Task (OT) - Real|
191661|NCT01404039|E7|Reported Event|Somatosensory Learning (SL) Control|
191662|NCT01404039|E6|Reported Event|Somatosensory Activation (SA)|
191663|NCT01404039|E5|Reported Event|Somatosensory Learning (SL) Blind|
191664|NCT01404039|E4|Reported Event|Somatosensory Learning (SL) Sighted|
191665|NCT01404039|E3|Reported Event|Motor Learning (ML) Control|
191666|NCT01404039|E2|Reported Event|Motor Learning (ML) Blind|
191667|NCT01404039|E1|Reported Event|Motor Learning (ML) Sighted|
191668|NCT01403987|B4|Baseline|Total|Total of all reporting groups
191669|NCT01403987|B3|Baseline|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
191670|NCT01403987|B2|Baseline|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
191671|NCT01403987|B1|Baseline|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
191672|NCT01403987|P3|Participant Flow|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
191673|NCT01403987|P2|Participant Flow|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
191674|NCT01403987|P1|Participant Flow|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
191675|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
191676|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
191677|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
192045|NCT01402115|P2|Participant Flow|Placebo|Placebo 15mg for 12 weeks
191678|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
191679|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
191680|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
191681|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
191682|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
191683|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
191684|NCT01403987|E3|Reported Event|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
191685|NCT01403987|E2|Reported Event|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
191686|NCT01403987|E1|Reported Event|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
191687|NCT01403805|B3|Baseline|Total|Total of all reporting groups
191688|NCT01403805|B2|Baseline|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;
1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
191689|NCT01403805|B1|Baseline|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
191690|NCT01403805|P2|Participant Flow|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;
1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
191691|NCT01403805|P1|Participant Flow|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
191692|NCT01403805|O1|Outcome|Died Before Oral Care Starting|Number of resident died before the start of oral care
191693|NCT01403805|O1|Outcome|Reject Vaccine|Number of resident to reject vaccine
191694|NCT01403805|O1|Outcome|Reject Oral Care|Number of resident to reject oral care
191695|NCT01403805|O1|Outcome|Leaving Nursing Home|Numer of resident for leaving nursing home
191696|NCT01403805|O2|Outcome|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;
1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
191697|NCT01403805|O1|Outcome|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
191698|NCT01403805|O2|Outcome|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;
1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
191700|NCT01403805|E2|Reported Event|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;
1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
191701|NCT01403805|E1|Reported Event|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
191702|NCT01402427|B3|Baseline|Total|Total of all reporting groups
191703|NCT01402427|B2|Baseline|Placebo|Placebo: Intraarterial administration of 10 mL saline.
191704|NCT01402427|B1|Baseline|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
191705|NCT01402427|P2|Participant Flow|Placebo|Placebo: Intraarterial administration of 10 mL saline.
191706|NCT01402427|P1|Participant Flow|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
191707|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
191708|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
191709|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
191710|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
191711|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
191712|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
191713|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
191714|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
191715|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
191716|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
191717|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
191718|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
191719|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
191720|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
191721|NCT01402427|E2|Reported Event|Placebo|Placebo: Intraarterial administration of 10 mL saline.
191722|NCT01402427|E1|Reported Event|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
191723|NCT01403376|B4|Baseline|Total|Total of all reporting groups
191724|NCT01403376|B3|Baseline|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
191725|NCT01403376|B2|Baseline|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
191726|NCT01403376|B1|Baseline|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
191727|NCT01403376|P3|Participant Flow|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
191728|NCT01403376|P2|Participant Flow|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
191729|NCT01403376|P1|Participant Flow|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
191730|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
191731|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
191732|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
191733|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
191734|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
191735|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
191736|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
191737|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
191738|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
191739|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
191740|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
191741|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
191742|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
191743|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
191744|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
191745|NCT01403376|E3|Reported Event|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
192046|NCT01402115|P1|Participant Flow|Polycan|Polycan 150mg for 12 weeks
191747|NCT01403376|E1|Reported Event|Teriflunomide 7mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
191748|NCT01403194|B1|Baseline|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
191749|NCT01403194|P1|Participant Flow|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
191750|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
191751|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
191752|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
191753|NCT01403194|E1|Reported Event|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
191754|NCT01403090|B1|Baseline|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
191755|NCT01403090|P1|Participant Flow|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
191756|NCT01403090|O1|Outcome|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
191757|NCT01403090|E1|Reported Event|Angel Catheter|
191758|NCT01403051|B3|Baseline|Total|Total of all reporting groups
191759|NCT01403051|B2|Baseline|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191760|NCT01403051|B1|Baseline|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191761|NCT01403051|P2|Participant Flow|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191762|NCT01403051|P1|Participant Flow|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191763|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191764|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191765|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191766|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191817|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191818|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191767|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191768|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191769|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191770|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191771|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191772|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191773|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191774|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191775|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191776|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191777|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191778|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191900|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191779|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191780|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191781|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191782|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191783|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191784|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191785|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191786|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191787|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191788|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191789|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191790|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191901|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191791|NCT01403051|E2|Reported Event|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191792|NCT01403051|E1|Reported Event|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).
Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
191793|NCT01402986|B5|Baseline|Total|Total of all reporting groups
191794|NCT01402986|B4|Baseline|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191795|NCT01402986|B3|Baseline|Placebo, Q2/4W - Cohort 2|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191796|NCT01402986|B2|Baseline|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191797|NCT01402986|B1|Baseline|Placebo, Q2W - Cohort 1|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191798|NCT01402986|P4|Participant Flow|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191799|NCT01402986|P3|Participant Flow|Placebo, Q2/4W - Cohort 2|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191800|NCT01402986|P2|Participant Flow|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191801|NCT01402986|P1|Participant Flow|Placebo, Q2W - Cohort 1|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191802|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191803|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191804|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191805|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191806|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191807|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191808|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191809|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191810|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191811|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191812|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191813|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191814|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191815|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191816|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191957|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
191819|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191820|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191821|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191822|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191823|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191824|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191825|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191826|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191827|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191828|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191829|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191830|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191831|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191832|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191833|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191834|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191835|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191836|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191837|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191838|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191839|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191840|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191841|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191842|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191843|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191844|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191845|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191846|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191847|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191848|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191849|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191850|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191851|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191852|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191853|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191854|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191855|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191856|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191857|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191858|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191859|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191860|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191861|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191862|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191863|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191864|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191865|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191866|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191867|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191868|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191869|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191870|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191871|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191872|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191873|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191874|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191875|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191876|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191877|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191878|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191879|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191880|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191881|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191882|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191883|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191884|NCT01402986|O1|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191885|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191886|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191887|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191888|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191889|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191890|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191891|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191892|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191893|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191894|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191895|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191896|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191897|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191898|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191899|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191902|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191903|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191904|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191905|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191906|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191907|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191908|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191909|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191910|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191911|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191912|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191913|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191914|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191915|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191916|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191917|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191918|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191919|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191920|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191921|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191922|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191923|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191924|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191925|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191926|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191927|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191928|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191929|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191930|NCT01402986|E3|Reported Event|Tralokinumab 300 mg Q2/4W|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191931|NCT01402986|E2|Reported Event|Tralokinumab 300 mg Q2W|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
191932|NCT01402986|E1|Reported Event|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
191933|NCT01402947|B3|Baseline|Total|Total of all reporting groups
191934|NCT01402947|B2|Baseline|MMX Mesalazine/Mesalamine + Ciprofloxacin First|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
191935|NCT01402947|B1|Baseline|MMX Placebo + Ciprofloxacin First|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
191936|NCT01402947|P2|Participant Flow|MMX Mesalazine/Mesalamine + Ciprofloxacin First|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
191937|NCT01402947|P1|Participant Flow|MMX Placebo + Ciprofloxacin First|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
191938|NCT01402947|O2|Outcome|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
191939|NCT01402947|O1|Outcome|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
191940|NCT01402947|O2|Outcome|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
191941|NCT01402947|O1|Outcome|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
191942|NCT01402947|E2|Reported Event|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
191943|NCT01402947|E1|Reported Event|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
191944|NCT01402869|B4|Baseline|Total|Total of all reporting groups
191945|NCT01402869|B3|Baseline|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
191946|NCT01402869|B2|Baseline|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
191947|NCT01402869|B1|Baseline|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
191948|NCT01402869|P3|Participant Flow|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
191949|NCT01402869|P2|Participant Flow|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
191950|NCT01402869|P1|Participant Flow|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
191951|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
191952|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
191953|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
191954|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
191955|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
191956|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
192019|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
191958|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
191959|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
191960|NCT01402869|E3|Reported Event|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
191961|NCT01402869|E2|Reported Event|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
191962|NCT01402869|E1|Reported Event|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
191963|NCT01402817|B1|Baseline|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
191964|NCT01402817|P1|Participant Flow|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
191965|NCT01402817|O1|Outcome|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
191966|NCT01402817|O1|Outcome|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Adults who tolerate the increase will go up to the maximum dose of 50mg. The maximum dose for children is 15mg/m2/day.
191967|NCT01402817|E1|Reported Event|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
191968|NCT01402700|B1|Baseline|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
191969|NCT01402700|P1|Participant Flow|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
191970|NCT01402700|O1|Outcome|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
191971|NCT01402700|E1|Reported Event|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
191972|NCT01402570|B1|Baseline|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
191973|NCT01402570|P1|Participant Flow|Study Group|All subjects took a three month trials of 1,000 mg of glutathione supplement
191974|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
191975|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
191976|NCT01402570|O1|Outcome|Study Group|All subjects took a three month trials of 1,000 mg of glutathione supplement
191977|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
191978|NCT01402570|E1|Reported Event|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
192020|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
192047|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
191979|NCT01402284|B1|Baseline|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
191980|NCT01402284|P1|Participant Flow|Carfilzomib, Lenalidomide, and Dexamethasone Therapy|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
191981|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
191982|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
191983|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
191984|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
191985|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
192021|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
192022|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
192023|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
192024|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
191986|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
191987|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
191988|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
191989|NCT01402284|E1|Reported Event|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
191990|NCT01402141|B3|Baseline|Total|Total of all reporting groups
191991|NCT01402141|B2|Baseline|Placebo(35g)|
191992|NCT01402141|B1|Baseline|Chungkookjang(35g)|
191993|NCT01402141|P2|Participant Flow|Placebo|"Placebo(3times/day, 3packs/day, 35g/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Chungkookjang."
191994|NCT01402141|P1|Participant Flow|Chungkookjang|"Chungkookjang(3times/day, 3packs/day, 35g/day) for 12weeks
Chungkookjang: The Chungkookjang was manufactured from raw beans, peels made after freeze-drying"
191995|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
191996|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
191997|NCT01402141|O2|Outcome|Placeb|Oral intake placebo(35g/day) for 12weeks
191998|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
191999|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
192000|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
192001|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
192002|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
192003|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
192004|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
192005|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
192006|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
192007|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
192008|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
192009|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
192010|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
192011|NCT01402141|E2|Reported Event|Placebo(35g)|Oral intake placebo(35g/day) for 12weeks
192012|NCT01402141|E1|Reported Event|Chungkookjang(35g)|Oral intake Chungkookjang(35g) for 12weeks.
192013|NCT01402128|B3|Baseline|Total|Total of all reporting groups
192014|NCT01402128|B2|Baseline|Placebo|Placebo for 12 weeks
192015|NCT01402128|B1|Baseline|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
192016|NCT01402128|P2|Participant Flow|Placebo|"Placebo(1times/day, 1packs/day, 3g/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Barley beta-glucan"
192017|NCT01402128|P1|Participant Flow|Barley Beta-glucan|"Barley beta-glucan(1times/day, 1packs/day, 3g/day) for 12weeks
Barley beta-glucan: Barley as raw material is milled by crushing the liquefaction and saccharification enzymes reacted after baking yeast (S. cereviasiae) for 48 h, is produced through the fermentation process."
192018|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
192060|NCT01402102|B2|Baseline|Placebo|Oral intake placebo(6.0g/day) for 12weeks
192061|NCT01402102|B1|Baseline|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
192062|NCT01402102|P2|Participant Flow|Placebo|Oral intake placebo(6.0g/day) for 12weeks
192063|NCT01402102|P1|Participant Flow|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
192064|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
192065|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
192066|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
192067|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
192068|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
192069|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
192070|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
192071|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
192072|NCT01402102|O2|Outcome|Placebo|Placebo 6.0g/day oral intake
192073|NCT01402102|O1|Outcome|Aged Garlic Powder|Aged garlic powder 6.0g/day oral intake
192074|NCT01402102|O2|Outcome|Placebo|Placebo 6.0g/day oral intake
192075|NCT01402102|O1|Outcome|Aged Garlic Powder|Aged garlic powder 6.0g/day oral intake
192076|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
192077|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
192078|NCT01402102|E2|Reported Event|Placebo|Oral intake placebo(6.0g/day) for 12weeks
192079|NCT01402102|E1|Reported Event|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
192080|NCT01402063|B3|Baseline|Total|Total of all reporting groups
192081|NCT01402063|B2|Baseline|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
192082|NCT01402063|B1|Baseline|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
+ intravenous PPX every week x 6 weeks for a total of 6 treatments
PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
192083|NCT01402063|P2|Participant Flow|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
192084|NCT01402063|P1|Participant Flow|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
+ intravenous PPX every week x 6 weeks for a total of 6 treatments
PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
192085|NCT01402063|O2|Outcome|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
192086|NCT01402063|O1|Outcome|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
+ intravenous PPX every week x 6 weeks for a total of 6 treatments
PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
192087|NCT01402063|E2|Reported Event|Radiation + Temozolomide and Maintenance|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
192088|NCT01402063|E1|Reported Event|Radiation Plus PPX and Maintenance|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
+ intravenous PPX every week x 6 weeks for a total of 6 treatments
PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
192089|NCT01401907|B3|Baseline|Total|Total of all reporting groups
192090|NCT01401907|B2|Baseline|Standard of Care|Subjects receives standard of care
192091|NCT01401907|B1|Baseline|Early Palliative Care|"Subjects receive standard of care with early palliative care.
early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
192092|NCT01401907|P2|Participant Flow|Standard of Care|Subjects receives standard of care
192093|NCT01401907|P1|Participant Flow|Early Palliative Care|"Subjects receive standard of care with early palliative care.
early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
192094|NCT01401907|O2|Outcome|Standard Oncology Care|
192095|NCT01401907|O1|Outcome|Early Palliative Care|
192096|NCT01401907|O2|Outcome|Standard Oncology Care|
192097|NCT01401907|O1|Outcome|Early Palliative Care|
192098|NCT01401907|O2|Outcome|Standard Oncology Care|
192099|NCT01401907|O1|Outcome|Early Palliative Care|
192100|NCT01401907|O2|Outcome|Standard Oncology Care|
192101|NCT01401907|O1|Outcome|Early Palliative Care|
192102|NCT01401907|O2|Outcome|Standard Oncology Care|
192104|NCT01401907|O2|Outcome|Standard of Care|Subjects receives standard of care
192105|NCT01401907|O1|Outcome|Early Palliative Care|"Subjects receive standard of care with early palliative care.
early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
192106|NCT01401907|O2|Outcome|Standard of Care|Subjects receives standard of care
192107|NCT01401907|O1|Outcome|Early Palliative Care|"Subjects receive standard of care with early palliative care.
early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
192108|NCT01401907|E2|Reported Event|Standard of Care|Subjects receives standard of care
192109|NCT01401907|E1|Reported Event|Early Palliative Care|"Subjects receive standard of care with early palliative care.
early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care."
192110|NCT01401842|B3|Baseline|Total|Total of all reporting groups
192111|NCT01401842|B2|Baseline|Stabilization Exercise|Low intensity core stabilization exercise
192112|NCT01401842|B1|Baseline|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
192113|NCT01401842|P2|Participant Flow|Stabilization Exercise|Low intensity core stabilization exercise
192114|NCT01401842|P1|Participant Flow|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
192115|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
192116|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
192117|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
192118|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
192119|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
192120|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
192121|NCT01401842|E2|Reported Event|Stabilization Exercise|Low intensity core stabilization exercise
192122|NCT01401842|E1|Reported Event|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
192123|NCT01401647|B4|Baseline|Total|Total of all reporting groups
192124|NCT01401647|B3|Baseline|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
192125|NCT01401647|B2|Baseline|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
192126|NCT01401647|B1|Baseline|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
192127|NCT01401647|P3|Participant Flow|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
192128|NCT01401647|P2|Participant Flow|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
192129|NCT01401647|P1|Participant Flow|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
192130|NCT01401647|O3|Outcome|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
192131|NCT01401647|O2|Outcome|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
192150|NCT01401595|E1|Reported Event|Night Eating Syndrome Open Label Treatment Group|Only the 32 participants with NES participated in the open label escitalopram treatment trial. One participant did not return after the first visit, and it is unknown if she ever started the medication. Thus 31 participants were included in the statistical analyses.
192132|NCT01401647|O1|Outcome|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
192133|NCT01401647|O3|Outcome|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
192134|NCT01401647|O2|Outcome|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
192135|NCT01401647|O1|Outcome|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
192136|NCT01401647|E3|Reported Event|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
192137|NCT01401647|E2|Reported Event|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
192138|NCT01401647|E1|Reported Event|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
192139|NCT01401595|B3|Baseline|Total|Total of all reporting groups
192140|NCT01401595|B2|Baseline|Control Subjects|10 control participants completed the baseline screening and SPECT scans.
192141|NCT01401595|B1|Baseline|Night Eaters|31 participants screened and diagnosed with NES attended the baseline treatment session and at least one follow-up appointment.
192142|NCT01401595|P2|Participant Flow|Control Subjects|"At the beginning of the study, control subjects were given a medical history, height and weight was measured, and BMI calculated. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing.
An ADAM SPECT-CT study of SERT binding was conducted which will compare SERT binding of the 10 control subjects with that of the 30 night eating subjects to assess SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls."
192143|NCT01401595|P1|Participant Flow|Night Eaters|"Subjects were given a medical history, and height and weight was measured. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. For women, a pregnancy test was also administered no more than 48 hours before SPECT-CT imaging and the beginning of Lexapro treatment. Lexapro treatment lasted 12 weeks.
escitalopram oxalate: The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome. An ADAM SPECT-CT study of SERT binding was conducted which will compare SERT binding in 30 night eaters with that of 10 controls. The first procedure assessed SPECT-CT images of night eaters and controls. Medication was administered starting at 10 mg daily, with increases up to 20 mg, as indicated and tolerated, for up to three months. Visits occured at baseline and weeks 1, 2, 4, 6, 8, 10, and 12."
192144|NCT01401595|O2|Outcome|Controls|The controls did not participate in the escitalopram treatment portion of the study. The just completed the baseline screening and SPECT scan.
192145|NCT01401595|O1|Outcome|Night Eating Syndrome Open Label Escitalopram Treatment|All NES subjects received the open label escitalopram treatment
192146|NCT01401595|O2|Outcome|Controls|The controls did not participate in the escitalopram treatment portion of the study. The just completed the baseline screening and SPECT scan.
192147|NCT01401595|O1|Outcome|Night Eating Syndrome Open Label Escitalopram Treatment|All NES subjects received the open label escitalopram treatment
192148|NCT01401595|O2|Outcome|Controls|The control participants did not participate in the treatment part of the study - only the baseline SPECT scans.
192149|NCT01401595|O1|Outcome|Night Eating Syndrome Open Label Escitalopram Treatment|All subjects with NES participated in the open label treatment with escitalopram, although of the 32 participants, 1 did not return after her initial medication visit. As it is unknown if this participants started the medication, only the 31 participants who returned to a second visit or more were included in the analysis
192151|NCT01401582|B3|Baseline|Total|Total of all reporting groups
192178|NCT01401517|O2|Outcome|40 mg Sodium Nitrite|"40 mg dose, BID
sodium nitrite: 40 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
192152|NCT01401582|B2|Baseline|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system
Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
192153|NCT01401582|B1|Baseline|Care as Usual|"care as usual, no intervention, just observation of natural change/ trajectories over time
published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
192154|NCT01401582|P2|Participant Flow|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system
Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
192155|NCT01401582|P1|Participant Flow|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
192156|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system
Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
192157|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
192158|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system
Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
192159|NCT01401582|O1|Outcome|Care as Usual|"care as usual, no intervention, just observation of natural change/ trajectories over time
published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
192160|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system
Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
192161|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
192162|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system
Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
192163|NCT01401582|O1|Outcome|Care as Usual|"care as usual, no intervention, just observation of natural change/ trajectories over time
published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
192164|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system
Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
192165|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
192166|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system
Implementation of Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
192167|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
192168|NCT01401582|E2|Reported Event|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system
Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
192169|NCT01401582|E1|Reported Event|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
192170|NCT01401517|B4|Baseline|Total|Total of all reporting groups
192171|NCT01401517|B3|Baseline|80 mg Sodium Nitrite|"80 mg dose, BID
sodium nitrite: 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
192172|NCT01401517|B2|Baseline|40 mg Sodium Nitrite|"40 mg dose, BID
40 mg sodium nitrite: 40 twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
192173|NCT01401517|B1|Baseline|Placebo|Placebo twice each day for 11 weeks
192174|NCT01401517|P3|Participant Flow|80 mg Sodium Nitrite|"80 mg dose, BID
sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
192175|NCT01401517|P2|Participant Flow|40 mg Sodium Nitrite|"40 mg dose, BID
sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
192176|NCT01401517|P1|Participant Flow|Placebo|sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.
192177|NCT01401517|O3|Outcome|80 mg Sodium Nitrite|"80 mg dose, BID
sodium nitrite:80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
192179|NCT01401517|O1|Outcome|Placebo|0 mg twice each day for 11 weeks.
192180|NCT01401517|E3|Reported Event|80 mg Sodium Nitrite|"80 mg dose, BID
sodium nitrite: 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
192181|NCT01401517|E2|Reported Event|40 mg Sodium Nitrite|"40 mg dose, BID
sodium nitrite: 40 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
192182|NCT01401517|E1|Reported Event|Placebo|sodium nitrite: 0 mg twice each day for 11 weeks .
192183|NCT01401478|B1|Baseline|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
192184|NCT01401478|P1|Participant Flow|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
192185|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
192186|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
192187|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
192188|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
192189|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
192190|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
192191|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
192192|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
192193|NCT01401478|E1|Reported Event|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
192194|NCT01401465|B3|Baseline|Total|Total of all reporting groups
192195|NCT01401465|B2|Baseline|Sequence MOM / CIC|Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
192196|NCT01401465|B1|Baseline|Sequence CIC / MOM|Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
192197|NCT01401465|P2|Participant Flow|MOM / CIC|Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
192198|NCT01401465|P1|Participant Flow|CIC / MOM|Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
192199|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192200|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192201|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192202|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192203|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192204|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192205|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192206|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192207|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
192208|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
192209|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
192210|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
192211|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
192212|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
192213|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192214|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192215|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192216|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192217|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192218|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192219|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192220|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192221|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192222|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192223|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192224|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192225|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192226|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192227|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192228|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192229|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192230|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192231|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192232|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192233|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192234|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192235|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192236|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192237|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192238|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192239|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192240|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192241|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192242|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
192243|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192257|NCT01401465|O1|Outcome|Ciclesonide Versus Mometasone|This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide
192258|NCT01401465|E2|Reported Event|Mometasone|Mometasone AQ 200 mcg
192259|NCT01401465|E1|Reported Event|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
192260|NCT01401361|B1|Baseline|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
192261|NCT01401361|P1|Participant Flow|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
192262|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
192263|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
192264|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
192265|NCT01401361|E1|Reported Event|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
192266|NCT01401322|B1|Baseline|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
192267|NCT01401322|P1|Participant Flow|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
192268|NCT01401322|O1|Outcome|Lenalidomide 50 mg/Day x 28 Days|"Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
Lenalidomide: 50 mg; po"
192269|NCT01401322|E1|Reported Event|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
192270|NCT01401283|B3|Baseline|Total|Total of all reporting groups
192271|NCT01401283|B2|Baseline|Control Group|hemodynamic management according to institutional clinical standards
192272|NCT01401283|B1|Baseline|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation
measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
192273|NCT01401283|P2|Participant Flow|Control Group|hemodynamic management according to institutional clinical standards
192274|NCT01401283|P1|Participant Flow|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation
measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
192275|NCT01401283|O2|Outcome|Control Group|hemodynamic management according to institutional clinical standards
192276|NCT01401283|O1|Outcome|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation
measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
192277|NCT01401283|O2|Outcome|Control Group|hemodynamic management according to institutional clinical standards
192278|NCT01401283|O1|Outcome|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation
measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
192279|NCT01401283|E2|Reported Event|Control Group|hemodynamic management according to institutional clinical standards
192280|NCT01401283|E1|Reported Event|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation
measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
192281|NCT01401257|B5|Baseline|Total|Total of all reporting groups
192282|NCT01401257|B4|Baseline|Placebo|"Oral Liquid formulation, bid, 12 months
Placebo: Liquid,5 ml, twice a day, 12-month treatment"
192283|NCT01401257|B3|Baseline|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192284|NCT01401257|B2|Baseline|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192285|NCT01401257|B1|Baseline|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192286|NCT01401257|P4|Participant Flow|Placebo|"Oral Liquid formulation, bid, 12 months
Placebo: Liquid,5 ml, twice a day, 12-month treatment"
192287|NCT01401257|P3|Participant Flow|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192288|NCT01401257|P2|Participant Flow|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192289|NCT01401257|P1|Participant Flow|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192290|NCT01401257|O4|Outcome|Placebo|"Oral Liquid formulation, bid, 12 months
Placebo: Liquid,5 ml, twice a day, 12-month treatment"
192291|NCT01401257|O3|Outcome|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192292|NCT01401257|O2|Outcome|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192293|NCT01401257|O1|Outcome|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192294|NCT01401257|E4|Reported Event|Placebo|"Oral Liquid formulation, bid, 12 months
Placebo: Liquid,5 ml, twice a day, 12-month treatment"
192295|NCT01401257|E3|Reported Event|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192296|NCT01401257|E2|Reported Event|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192297|NCT01401257|E1|Reported Event|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months
PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
192298|NCT01401166|B3|Baseline|Total|Total of all reporting groups
192299|NCT01401166|B2|Baseline|Cohort 2 Overall: SC (Vial) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192300|NCT01401166|B1|Baseline|Cohort 1 Overall: SC (SID) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192301|NCT01401166|P4|Participant Flow|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192302|NCT01401166|P3|Participant Flow|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
192303|NCT01401166|P2|Participant Flow|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192304|NCT01401166|P1|Participant Flow|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by healthcare professional (HCP). Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 milligrams (mg) for all cycles where SC Herceptin was given, and the IV dose was 6 milligrams per kilogram (mg/kg) for all cycles where IV Herceptin was given.
192305|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192730|NCT01399866|O1|Outcome|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth
Placebo"
192306|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
192307|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192308|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
192309|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192310|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
192311|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192312|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
192313|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192314|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
192324|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
192315|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192316|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
192317|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192318|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
192319|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192320|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
192321|NCT01401166|O1|Outcome|All HCPs: SC and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.
192322|NCT01401166|O1|Outcome|All HCPs: SC and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.
192323|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192325|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192326|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
192327|NCT01401166|E10|Reported Event|Cohort 2 Overall: SC (Vial) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192328|NCT01401166|E9|Reported Event|Cohort 2: SC (Vial) Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP.
192329|NCT01401166|E8|Reported Event|Cohort 2: IV Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants were planned to receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. However, under protocol deviation a small number of participants received IV Herceptin as a 6-mg/kg dose for this period. Administration was performed by HCP.
192330|NCT01401166|E7|Reported Event|Cohort 2: IV Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
192331|NCT01401166|E6|Reported Event|Cohort 2: SC (Vial) Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via handheld syringe using the vial formulation as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
192332|NCT01401166|E5|Reported Event|Cohort 1 Overall: SC (SID) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
192333|NCT01401166|E4|Reported Event|Cohort 1: SC (SID) Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID as a 600-mg dose under the direction of a trained HCP.
192334|NCT01401166|E3|Reported Event|Cohort 1: IV Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received IV Herceptin as a 6-mg/kg dose for up to 10 remaining cycles. Administration was performed by HCP.
192335|NCT01401166|E2|Reported Event|Cohort 1: IV Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
192336|NCT01401166|E1|Reported Event|Cohort 1: SC (SID) Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via SID as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
192337|NCT01401153|B3|Baseline|Total|Total of all reporting groups
192338|NCT01401153|B2|Baseline|Skipping Lunch|No lunch (water)
192339|NCT01401153|B1|Baseline|Having Lunch|Lunch ad libitum (pasta Bolognese, apple and water)
192340|NCT01401153|P2|Participant Flow|Skipping Lunch|No lunch (water)
192341|NCT01401153|P1|Participant Flow|Having Lunch|Lunch ad libitum (pasta Bolognese, apple and water)
192342|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
192343|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
192344|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
192345|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
192346|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
192347|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
192373|NCT01401101|B2|Baseline|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.
Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
192374|NCT01401101|B1|Baseline|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.
quality improvement: Care Manager (CM) intervention"
192375|NCT01401101|P2|Participant Flow|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.
Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
192376|NCT01401101|P1|Participant Flow|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.
quality improvement: Care Manager (CM) intervention"
192377|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.
Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
192378|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.
quality improvement: Care Manager (CM) intervention"
192379|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.
Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
192380|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.
quality improvement: Care Manager (CM) intervention"
192381|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.
Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
192382|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.
quality improvement: Care Manager (CM) intervention"
192383|NCT01401101|E2|Reported Event|Treatment-as-Usual (TAU)|The TAU condition consists of only the clinician education and patient screening without written feedback.
192384|NCT01401101|E1|Reported Event|PTSD Care Management (PCM)|There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.
192385|NCT01401062|B3|Baseline|Total|Total of all reporting groups
192386|NCT01401062|B2|Baseline|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy"
192387|NCT01401062|B1|Baseline|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy"
192388|NCT01401062|P2|Participant Flow|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy"
192389|NCT01401062|P1|Participant Flow|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy"
192763|NCT01399723|O2|Outcome|Penicillin|Benzyl penicillin 50000 IU/kg 6 hourly
192390|NCT01401062|O2|Outcome|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy"
192391|NCT01401062|O1|Outcome|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy"
192392|NCT01401062|E2|Reported Event|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy"
192393|NCT01401062|E1|Reported Event|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy"
192394|NCT01401049|B3|Baseline|Total|Total of all reporting groups
192395|NCT01401049|B2|Baseline|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).
Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
192396|NCT01401049|B1|Baseline|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.
Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
192397|NCT01401049|P2|Participant Flow|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).
Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
192398|NCT01401049|P1|Participant Flow|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.
Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
192399|NCT01401049|O2|Outcome|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).
Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
192400|NCT01401049|O1|Outcome|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.
Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
192401|NCT01401049|E2|Reported Event|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).
Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
192402|NCT01401049|E1|Reported Event|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.
Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
192403|NCT01401023|B1|Baseline|CDAD Patient|"Open non-comparative trial
Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
192404|NCT01401023|P1|Participant Flow|Clostridium Difficile Patient|"Open non-comparative trial
Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
192405|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial
Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
192406|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial
Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
192407|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial
Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
192408|NCT01401023|E1|Reported Event|CDAD Patient|"Open non-comparative trial
Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
192409|NCT01401010|B3|Baseline|Total|Total of all reporting groups
192410|NCT01401010|B2|Baseline|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
192411|NCT01401010|B1|Baseline|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
192412|NCT01401010|P2|Participant Flow|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
192413|NCT01401010|P1|Participant Flow|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
192414|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
192415|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
192416|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
192417|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
192418|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
192419|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
192420|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
192421|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
192422|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
192423|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
192424|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
192425|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
192426|NCT01401010|O4|Outcome|1000 mg Doripenem 4 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
192427|NCT01401010|O3|Outcome|1000 mg Doripenem 1 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
192428|NCT01401010|O2|Outcome|500 mg Doripenem 4 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
192429|NCT01401010|O1|Outcome|500 mg Doripenem 1 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
192430|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
192431|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
192432|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
192433|NCT01401010|E2|Reported Event|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
192434|NCT01401010|E1|Reported Event|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
192435|NCT01400958|B3|Baseline|Total|Total of all reporting groups
192436|NCT01400958|B2|Baseline|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
192437|NCT01400958|B1|Baseline|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
192438|NCT01400958|P2|Participant Flow|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
192439|NCT01400958|P1|Participant Flow|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
192554|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192440|NCT01400958|O2|Outcome|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
192441|NCT01400958|O1|Outcome|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
192442|NCT01400958|O2|Outcome|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
192443|NCT01400958|O1|Outcome|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
192444|NCT01400958|E2|Reported Event|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
192445|NCT01400958|E1|Reported Event|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
192446|NCT01400932|B3|Baseline|Total|Total of all reporting groups
192447|NCT01400932|B2|Baseline|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192448|NCT01400932|B1|Baseline|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192449|NCT01400932|P2|Participant Flow|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192450|NCT01400932|P1|Participant Flow|GI148512|Participants applied 2 finger tip units (FTU) of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192451|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192452|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192453|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192454|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192455|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192456|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192457|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192458|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192725|NCT01399866|B2|Baseline|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth
D-cycloserine: 2 single weekly doses, 50 mg capsule"
192459|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192460|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192461|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192462|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192463|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192464|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192465|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192466|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192467|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192468|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192469|NCT01400932|E2|Reported Event|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192470|NCT01400932|E1|Reported Event|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
192471|NCT01400919|B1|Baseline|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
192472|NCT01400919|P1|Participant Flow|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
192473|NCT01400919|O1|Outcome|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
192474|NCT01400919|E1|Reported Event|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
192475|NCT01400906|B1|Baseline|Placebo, FP 100 µg, and FP 500 µg in 1 of 6 Sequences|All participants received one of the following three treatments in one of three treatment periods, one inhalation in the morning and evening from Day 1 to 6 and one inhalation on the morning on Day 7, from the Dry Powder Inhaler (DPI): Placebo; Fluticasone propionate (FP) 100 micrograms (µg); and FP 500 µg. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FP 100 µg, FP 500 µg; (2) Placebo, FP 500 µg, FP 100 µg; (3) FP 100 µg, Placebo, FP 500 µg; (4) FP 100 µg, FP 500 µg, Placebo; (5) FP 500 µg, Placebo, FP 100 µg; (6) FP 500 µg, FP 100 µg, Placebo. The three treatment periods were separated by a washout period of 14 days.
192476|NCT01400906|P6|Participant Flow|Sequence 6: FP 500 µg, FP 100 µg, Placebo|Participants received FP 500 µg, FP 100 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
192477|NCT01400906|P5|Participant Flow|Sequence 5: FP 500 µg, Placebo, FP 100 µg|Participants received FP 500 µg, Placebo, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
192478|NCT01400906|P4|Participant Flow|Sequence 4: FP 100 µg, FP 500 µg, Placebo|Participants received FP 100 µg, FP 500 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
192726|NCT01399866|B1|Baseline|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth
Placebo"
192764|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
192479|NCT01400906|P3|Participant Flow|Sequence 3: FP 100 µg, Placebo, FP 500 µg|Participants received FP 100 µg, Placebo, and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
192480|NCT01400906|P2|Participant Flow|Sequence 2: Placebo, FP 500 µg, FP 100 µg|Participants received Placebo, FP 500 µg, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
192481|NCT01400906|P1|Participant Flow|Sequence 1: Placebo, FP 100 µg, FP 500 µg|Participants received placebo, Fluticasone Propionate (FP) 100 micrograms (µg), and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 14 days.
192482|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192483|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192484|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192485|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192486|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192487|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192488|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192489|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192490|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192491|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192492|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192493|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192494|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192495|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192496|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192497|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192498|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192499|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192500|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192765|NCT01399723|E2|Reported Event|Benzyl Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
192501|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192502|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192503|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192504|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192505|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192506|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192507|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192508|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192509|NCT01400906|E3|Reported Event|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192510|NCT01400906|E2|Reported Event|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192511|NCT01400906|E1|Reported Event|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
192512|NCT01400893|B3|Baseline|Total|Total of all reporting groups
192513|NCT01400893|B2|Baseline|CRRT Alone|Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
192514|NCT01400893|B1|Baseline|CRRT + SCD|"Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
192515|NCT01400893|P2|Participant Flow|CRRT Alone|Patients with a diagnosis of acute kidney injury and multiorgan failure requiring CRRT will be randomized
192516|NCT01400893|P1|Participant Flow|CRRT + SCD|"Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized
SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
192517|NCT01400893|O2|Outcome|CRRT Alone|Patients with a diagnosis of AKI will be randomized
192518|NCT01400893|O1|Outcome|CRRT + SCD|"Patients with a diagnosis of AKI will be randomized
SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
192519|NCT01400893|O2|Outcome|CRRT Alone|Patients with a diagnosis of AKI requires CRRT will be randomized
192520|NCT01400893|O1|Outcome|CRRT + SCD|"Patients with a diagnosis of AKI requires CRRT will be randomized
SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
192521|NCT01400893|E2|Reported Event|CRRT Alone|Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
192555|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192556|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192766|NCT01399723|E1|Reported Event|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
192522|NCT01400893|E1|Reported Event|CRRT + SCD|"Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits."
192523|NCT01400880|B1|Baseline|Primary|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
192524|NCT01400880|P1|Participant Flow|Electrode Sensor, TOCO and IUPC|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, TOCO and IUPC
192525|NCT01400880|O1|Outcome|Electrode Sensor, TOCO and IUPC|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation studied with electrode sensor, Tocodynamometer and IUPC
192526|NCT01400880|E1|Reported Event|Primary|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
192527|NCT01400841|B1|Baseline|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192528|NCT01400841|P1|Participant Flow|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192529|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192530|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192531|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192532|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192533|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192534|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192535|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192536|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192537|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192538|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192539|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192540|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192541|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192542|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192543|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192544|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192545|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192546|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192547|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192548|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192549|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192550|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192551|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192552|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192553|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192557|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192558|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192559|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192560|NCT01400841|E1|Reported Event|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair
HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
192561|NCT01400698|B5|Baseline|Total|Total of all reporting groups
192562|NCT01400698|B4|Baseline|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192563|NCT01400698|B3|Baseline|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192564|NCT01400698|B2|Baseline|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192565|NCT01400698|B1|Baseline|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192566|NCT01400698|P6|Participant Flow|Observation (C)|Participants with bone age >12 years for girls or 14 years for boys or refused to be treated in any of the above groups were followed without treatment until they reached final height for a maximum duration of 10.6 years.
192567|NCT01400698|P5|Participant Flow|Observed Then Randomized to Observation (B2)|Participants with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to observation group with no treatment until they reached final height for a maximum duration of 10.6 years. Participants whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
192568|NCT01400698|P4|Participant Flow|Observed Then Randomized to Saizen® (B1)|Participants with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to receive continuous treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Participants whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
192569|NCT01400698|P3|Participant Flow|Observed, Not Randomized (B0)|Participants with bone age <=12 years for girls or 14 years for boys and height greater than (>) -2 SD were observed until first signs of puberty but not randomized.
192570|NCT01400698|P2|Participant Flow|Saizen® Intermittent (A2)|Participants with bone age <=12 years for girls or 14 years for boys and height <=-2 SD received intermittent treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Intermittent treatment was given on an individual basis depending on the height achieved during the study.
192571|NCT01400698|P1|Participant Flow|Saizen® Continuous (A1)|Participants with bone age less than or equal to (<=) 12 years for girls or 14 years for boys and height <=-2 standard deviation (SD) received continuous treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc) until they reached final height for a maximum duration of 10.6 years.
192572|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192573|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192574|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192575|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192576|NCT01400698|O2|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192577|NCT01400698|O1|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192578|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192579|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192580|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192581|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192582|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192583|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192584|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192767|NCT01399697|B4|Baseline|Total|Total of all reporting groups
192585|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192586|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192587|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192588|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192589|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192590|NCT01400698|E2|Reported Event|Treated|Included all participants who received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192591|NCT01400698|E1|Reported Event|Not Treated|Included all participants who did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
192592|NCT01400516|B3|Baseline|Total|Total of all reporting groups
192593|NCT01400516|B2|Baseline|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
192594|NCT01400516|B1|Baseline|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
192595|NCT01400516|P2|Participant Flow|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
192596|NCT01400516|P1|Participant Flow|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
192597|NCT01400516|O2|Outcome|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
192598|NCT01400516|O1|Outcome|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
192599|NCT01400516|O2|Outcome|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
192600|NCT01400516|O1|Outcome|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
192601|NCT01400516|O2|Outcome|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
192602|NCT01400516|O1|Outcome|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
192603|NCT01400516|E2|Reported Event|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
192604|NCT01400516|E1|Reported Event|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
192605|NCT01400451|B4|Baseline|Total|Total of all reporting groups
192606|NCT01400451|B3|Baseline|720 mg Vemurafenib|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.
192607|NCT01400451|B2|Baseline|3 mg/kg Ipilimumab + 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).
Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment."
192608|NCT01400451|B1|Baseline|3 mg/kg Ipilimumab + 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).
Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1, plus 960 mg vemurafenib orally twice daily throughout combination treatment."
192609|NCT01400451|P3|Participant Flow|720 mg Vemurafenib|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily. Note: the dose of vemurafenib could be escalated from 720 mg to 960 mg, at the investigator’s discretion.
192610|NCT01400451|P2|Participant Flow|3 mg/kg Ipilimumab + 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).
Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment."
192611|NCT01400451|P1|Participant Flow|3 mg/kg Ipilimumab + 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).
Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily throughout combination treatment."
192612|NCT01400451|O2|Outcome|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
192613|NCT01400451|O1|Outcome|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily continuing during combination treatment.
192614|NCT01400451|O2|Outcome|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
192615|NCT01400451|O1|Outcome|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily and continuing during combination treatment.
192616|NCT01400451|O3|Outcome|720 mg Vemurafenib Alone|"These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the DLTs were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.
Events from first day of vemurafenib to last day of treatment + 90 days, up to date of data cut off for Primary Endpoint."
192617|NCT01400451|O2|Outcome|720 mg Vemurafenib Lead in Period|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).
Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
192618|NCT01400451|O1|Outcome|960 mg Vemurafenib Lead in Period|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).
Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
192619|NCT01400451|E5|Reported Event|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
192620|NCT01400451|E4|Reported Event|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily and continuing during combination treatment.
192621|NCT01400451|E3|Reported Event|Lead- In Period 720 mg Vemurafenib Alone|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the DLTs were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.
192622|NCT01400451|E2|Reported Event|Lead-In Period 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).
Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
192623|NCT01400451|E1|Reported Event|Lead-In Period 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).
Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
192624|NCT01400425|B1|Baseline|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
192625|NCT01400425|P1|Participant Flow|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
192626|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
192627|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
192727|NCT01399866|P2|Participant Flow|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth
D-cycloserine: 2 single weekly doses, 50 mg capsule"
192628|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
192629|NCT01400425|O3|Outcome|Subjects With a Negative Scan|Subjects with progressive cognitive decline that received a negative scan.
192630|NCT01400425|O2|Outcome|Subjectss With a Positive Scan|Subjects with progressive cognitive decline that received a positive florbetapir scan.
192631|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
192632|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
192633|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
192634|NCT01400425|E1|Reported Event|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
192635|NCT01400412|B3|Baseline|Total|Total of all reporting groups
192636|NCT01400412|B2|Baseline|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192637|NCT01400412|B1|Baseline|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192638|NCT01400412|P2|Participant Flow|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192639|NCT01400412|P1|Participant Flow|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192640|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192728|NCT01399866|P1|Participant Flow|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth
Placebo"
193329|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
192641|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192642|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192643|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192644|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192645|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192646|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192647|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192648|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192649|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192708|NCT01400139|P1|Participant Flow|Hydrocodone Bitartrate (HYD)|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
192709|NCT01400139|O2|Outcome|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
192710|NCT01400139|O1|Outcome|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
192650|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192651|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192652|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192653|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192654|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192655|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192656|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192657|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192658|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192711|NCT01400139|O2|Outcome|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
192712|NCT01400139|O1|Outcome|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
192729|NCT01399866|O2|Outcome|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth
D-cycloserine: 2 single weekly doses, 50 mg capsule"
192659|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192660|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192661|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192662|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192663|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192664|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192665|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192666|NCT01400412|O2|Outcome|TDF Arm: DRV/r + TDF + FTC + MVC Placebo|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one tablet."
192667|NCT01400412|O1|Outcome|MVC Arm: DRV/r + MVC + FTC + TDF Placebo|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.
Maraviroc: Maraviroc was administered orally once a day as one 150 mg tablet."
192713|NCT01400139|E2|Reported Event|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
192714|NCT01400139|E1|Reported Event|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
192715|NCT01400113|B3|Baseline|Total|Total of all reporting groups
192716|NCT01400113|B2|Baseline|Placebo|60 patients were randomized to this group
192668|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192669|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192670|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192671|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192672|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192673|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192674|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192675|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192676|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192717|NCT01400113|B1|Baseline|Asenapine|60 patients were randomized to this group
192718|NCT01400113|P2|Participant Flow|Placebo|60 patients were randomized to this group
192719|NCT01400113|P1|Participant Flow|Asenapine|60 patients were randomized to this group
192720|NCT01400113|O2|Outcome|Placebo|60 patients were randomized to this group
192721|NCT01400113|O1|Outcome|Asenapine|60 patients were randomized to this group
192722|NCT01400113|E2|Reported Event|Placebo|Placebo: Placebo Sublingual Tablet, single-dose
192677|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192678|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192679|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192680|NCT01400412|E2|Reported Event|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
192681|NCT01400412|E1|Reported Event|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD
Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
192682|NCT01400243|B3|Baseline|Total|Total of all reporting groups
192683|NCT01400243|B2|Baseline|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192684|NCT01400243|B1|Baseline|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192685|NCT01400243|P2|Participant Flow|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192686|NCT01400243|P1|Participant Flow|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192687|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192688|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192689|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192690|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192691|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192692|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192693|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192694|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192695|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192696|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192697|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192698|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192699|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192700|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192701|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192702|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192703|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192704|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192705|NCT01400243|E2|Reported Event|Placebo Patch|"Placebo patch for 15-day quit period
Placebo Patch: Placebo patch"
192706|NCT01400243|E1|Reported Event|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg"
192707|NCT01400139|B1|Baseline|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
192723|NCT01400113|E1|Reported Event|Asenapine|Asenapine: Asenapine Sublingual Tablet 10mg, single-dose
192724|NCT01399866|B3|Baseline|Total|Total of all reporting groups
192731|NCT01399866|E2|Reported Event|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth
D-cycloserine: 2 single weekly doses, 50 mg capsule"
192732|NCT01399866|E1|Reported Event|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth
Placebo"
192733|NCT01399788|B1|Baseline|Entire Study Population|Includes participants randomized to receive Myrin-P Forte first and four single drug references first.
192734|NCT01399788|P2|Participant Flow|Four Single Drug References First, Then Myrin-P Forte|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in first intervention period; and single oral dose of 4 FDC tablets of Myrin-P Forte (each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in second intervention period. A washout period of at least 1 week was maintained between each period.
192735|NCT01399788|P1|Participant Flow|Myrin-P Forte First, Then Four Single Drug References|Single oral dose of 4 fixed dose combination (FDC) tablets of Myrin-P Forte (each tablet contains 150 milligram (mg) rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in first intervention period; and single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in second intervention period. A washout period of at least 1 week was maintained between each period.
192736|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
192737|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
192738|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
192739|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
192740|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
192741|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
192742|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
192743|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
192744|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
192745|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
192746|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
192747|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
192748|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
192749|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
192750|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
192751|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
192752|NCT01399788|E2|Reported Event|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
192753|NCT01399788|E1|Reported Event|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
192754|NCT01399723|B3|Baseline|Total|Total of all reporting groups
192755|NCT01399723|B2|Baseline|Penicillin|Benzyl penicillin 50000 IU 6 hourly
192756|NCT01399723|B1|Baseline|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
192757|NCT01399723|P2|Participant Flow|Benzyl Penicillin 50,000IU/kg 6 Hourly|Benzyl penicillin: Intravenous 50,000IU/kg 6 hourly
192758|NCT01399723|P1|Participant Flow|Amoxicillin 45mg/kg 12 Hourly|Amoxicillin: Oral 45mg/kg 12 hourly
192759|NCT01399723|O2|Outcome|Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
192760|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
192761|NCT01399723|O2|Outcome|Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
192762|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
192768|NCT01399697|B3|Baseline|TCZ + Placebo (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24.
192769|NCT01399697|B2|Baseline|TCZ + MTX (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24.
192770|NCT01399697|B1|Baseline|TCZ + MTX (Not Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
192771|NCT01399697|P3|Participant Flow|TCZ + Placebo (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24.
192772|NCT01399697|P2|Participant Flow|TCZ + MTX (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24.
192773|NCT01399697|P1|Participant Flow|Tocilizumab (TCZ) Plus (+) Methotrexate (Not Randomized)|Participants received TCZ 8 milligrams per kilogram (mg/kg; maximum 800 mg) via intravenous (IV) infusion every 4 weeks (q4w) through Week 24 (total of 7 infusions). Participants also received methotrexate (MTX) capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
192774|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
192775|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
192776|NCT01399697|O2|Outcome|Tocilizumab + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
192777|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
192778|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
192779|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
192780|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
192781|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
192782|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
192783|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
192784|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
192785|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
192786|NCT01399697|O2|Outcome|Tocilizumab + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
192787|NCT01399697|O1|Outcome|Tocilizumab + Methotrexate (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
192788|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
192789|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
192790|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
192791|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
192792|NCT01399697|E5|Reported Event|TCZ + Placebo (Post-randomization)|TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and matching placebo MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2.
192816|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
193330|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
192793|NCT01399697|E4|Reported Event|TCZ + MTX (Post-randomization)|TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2.
192794|NCT01399697|E3|Reported Event|TCZ + Placebo (Pre-randomization)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and matching MTX placebo in the second part of the study. Response was defined as participants having DAS28 score <=3.2.
192795|NCT01399697|E2|Reported Event|TCZ + MTX (Pre-randomization)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and MTX in the second part of the study. Response was defined as participants having DAS28 score less than or equal to (<=)3.2.
192796|NCT01399697|E1|Reported Event|TCZ + MTX (Not Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
192797|NCT01399619|B3|Baseline|Total|Total of all reporting groups
192798|NCT01399619|B2|Baseline|Faldaprevir 240mg -T|patient to receive Faldaprevir 240 mg once a day for 12 or 24 weeks and PegIFN/RBV for 24 or 48 weeks + patients who received Faldaprevir 240 mg and discontinued prior to week 12.
192799|NCT01399619|B1|Baseline|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192800|NCT01399619|P4|Participant Flow|Faldaprevir 240 mg -NR (Prior to Re-randomization at Week 12)|Patients initially assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at WK 12.
192801|NCT01399619|P3|Participant Flow|Faldaprevir 240mg-24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192802|NCT01399619|P2|Participant Flow|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192803|NCT01399619|P1|Participant Flow|Faldaprevir 120mg -24W|Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192804|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
192805|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192806|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192807|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192808|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192809|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
192810|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192811|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192812|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192813|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192814|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
192815|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192898|NCT01399229|E1|Reported Event|Pregnant|
193331|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
192817|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192818|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192819|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
192820|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192821|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192822|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192823|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192824|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
192825|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192826|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192827|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192828|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192829|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
192830|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192831|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192832|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192833|NCT01399619|O1|Outcome|Faldaprevir 120mg -24W|Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192834|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
192835|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192836|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192837|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192838|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192839|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
192840|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192841|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192842|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192843|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192844|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
192845|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192846|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192847|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192848|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192849|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
192850|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192851|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192852|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192853|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192854|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
192855|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192856|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue BI 201335 to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192857|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192858|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192859|NCT01399619|E4|Reported Event|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
192860|NCT01399619|E3|Reported Event|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192861|NCT01399619|E2|Reported Event|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192862|NCT01399619|E1|Reported Event|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
192863|NCT01399593|B3|Baseline|Total|Total of all reporting groups
192864|NCT01399593|B2|Baseline|Standard of Care (SOC)|"Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
Data reported are summarized for the Prevention phase of the study, i.e., 9-week treatment plus an additional 60-day washout period. For those patients randomized to the SOC treatment group who were switched to eculizumab for treatment of AMR, from that point forward their data were no longer included in the Prevention Phase."
192865|NCT01399593|B1|Baseline|Eculizumab|"Patients in the eculizumab treatment group were to receive eculizumab for 9 weeks according to the following dosing regimen:
Eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
Data reported are summarized for the Prevention phase of the study, i.e., 9-week treatment plus an additional 60-day washout period."
192866|NCT01399593|P2|Participant Flow|Standard of Care|Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
192867|NCT01399593|P1|Participant Flow|Eculizumab|Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9).
192868|NCT01399593|O2|Outcome|Standard of Care|Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
192869|NCT01399593|O1|Outcome|Eculizumab|Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
192870|NCT01399593|E2|Reported Event|Standard of Care|"Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg. Data reported are summarized for the Prevention phase of the study, i.e., 9-week treatment plus an additional 60-day washout period. For those patients randomized to the SOC treatment group who were switched to eculizumab for treatment of AMR, from that point forward their data were no longer included in the Prevention Phase."
192871|NCT01399593|E1|Reported Event|Eculizumab|"Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
Data reported are summarized for the Prevention phase of the study, i.e., 9-week treatment with eculizumab plus an additional 60-day washout period."
192872|NCT01399268|B3|Baseline|Total|Total of all reporting groups
192873|NCT01399268|B2|Baseline|Control|"Saline IV Q8hr x3
Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
192874|NCT01399268|B1|Baseline|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3
Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
192875|NCT01399268|P2|Participant Flow|Control|"Saline IV Q8hr x3
Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
192876|NCT01399268|P1|Participant Flow|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3
Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
192877|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3
Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
192878|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3
Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
192879|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3
Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
192880|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3
Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
192881|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3
Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
192882|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3
Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
192883|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3
Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
192884|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3
Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
192885|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3
Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
192886|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3
Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
192887|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3
Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
192888|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3
Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
192889|NCT01399268|O2|Outcome|Control|"Saline IV Q8hr x3
Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
192890|NCT01399268|O1|Outcome|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3
Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
192891|NCT01399268|E2|Reported Event|Control|"Saline IV Q8hr x3
Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times"
192892|NCT01399268|E1|Reported Event|Steroid|"Hydrocortisone 100 mg IV Q 8hrs x3
Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times"
192893|NCT01399229|B1|Baseline|Pregnant|The study focused on recruiting laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients.
192894|NCT01399229|P3|Participant Flow|Pregnant, Term, Non Labor|Pregnant term women independently determined to be in labor.
192895|NCT01399229|P2|Participant Flow|Pregnant, Preterm, Non Labor|Pregnant preterm women independently determined to not be in labor.
192896|NCT01399229|P1|Participant Flow|Pregnant, Preterm, In Labor|Pregnant preterm women independently determined to be in labor.
192897|NCT01399229|O1|Outcome|Pregnant Patents With Uterine Contractions|Patient contractions were monitored with both SureCALL® Labor Monitor® and Tocodynamometer. The times of peak contractions recorded by both devices were compared, and the time differences between contractions were assessed.
192899|NCT01399190|B1|Baseline|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
192900|NCT01399190|P1|Participant Flow|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
192901|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
192902|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
192903|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
192904|NCT01399190|E1|Reported Event|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
192905|NCT01399125|B3|Baseline|Total|Total of all reporting groups
192906|NCT01399125|B2|Baseline|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
192907|NCT01399125|B1|Baseline|Rivastigmine Patch|Once-daily target patch size 10 cm²
192908|NCT01399125|P2|Participant Flow|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
192909|NCT01399125|P1|Participant Flow|Rivastigmine Patch|Once-daily target patch size 10 cm²
192910|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
192911|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
192912|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
192913|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
192914|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
192915|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
192916|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
192917|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
192918|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
192919|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
192920|NCT01399125|E2|Reported Event|Rivastigmine Capsule|Twice-daily target dose of 6 mg oral capsule
192921|NCT01399125|E1|Reported Event|Rivastigmine Patch|Once-daily target patch size 10 cm²
192922|NCT01399099|B1|Baseline|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
192923|NCT01399099|P1|Participant Flow|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
192924|NCT01399099|O2|Outcome|Control Side|Half of the abdomnioplasty incision was treated according to the Investigator’s standard of care. Participant served as his/her own control.
192925|NCT01399099|O1|Outcome|Treated Side|Half of the abdomnioplasty incision was treated with the embrace device.
192926|NCT01399099|E1|Reported Event|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
192927|NCT01399047|B3|Baseline|Total|Total of all reporting groups
192928|NCT01399047|B2|Baseline|Group B: Placebo to Mycophenolate Crossover|Subjects received one treatment period (8 weeks) of placebo, then, after a 4-week washout, received one treatment period (8 weeks) of mycophenolate, in a blinded manner.
192929|NCT01399047|B1|Baseline|Group A: Mycophenolate to Placebo Crossover|Subjects received one treatment period (8 weeks) of mycophenolate, then, after a 4-week washout, received one treatment period (8 weeks) of placebo, in a blinded manner.
192930|NCT01399047|P2|Participant Flow|Group B: Placebo to Mycophenolate Crossover|Subjects received one treatment period (8 weeks) of placebo, then, after a 4-week washout, received one treatment period (8 weeks) of mycophenolate, in a blinded manner.
192931|NCT01399047|P1|Participant Flow|Group A: Mycophenolate to Placebo Crossover|Subjects received one treatment period (8 weeks) of mycophenolate, then, after a 4-week washout, received one treatment period (8 weeks) of placebo, in a blinded manner.
192932|NCT01399047|O2|Outcome|Placebo|Includes data from all subjects while on placebo, regardless of treatment order.
192933|NCT01399047|O1|Outcome|Mycophenolate|Includes data from all subjects while on mycophenolate, regardless of treatment order.
192934|NCT01399047|E2|Reported Event|Placebo|Includes data from all subjects while on placebo, regardless of order.
192935|NCT01399047|E1|Reported Event|Mycophenolate|Includes data from all subjects while on mycophenolate, regardless of order.
192936|NCT01399008|B4|Baseline|Total|Total of all reporting groups
192937|NCT01399008|B3|Baseline|Placebo|Placebo plus Allopurinol 300 mg
192938|NCT01399008|B2|Baseline|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
192939|NCT01399008|B1|Baseline|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
192940|NCT01399008|P3|Participant Flow|Placebo|Placebo plus Allopurinol 300 mg
192941|NCT01399008|P2|Participant Flow|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
192942|NCT01399008|P1|Participant Flow|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
192943|NCT01399008|O3|Outcome|Placebo|Placebo plus Allopurinol 300 mg
192944|NCT01399008|O2|Outcome|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
192945|NCT01399008|O1|Outcome|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
192946|NCT01399008|E3|Reported Event|Placebo Plus Allopurinol 300 mg|Placebo plus allopurinol 300 mg (Safety Population)
192947|NCT01399008|E2|Reported Event|Arhalofenate 600 mg Plus Allopurinol 300 mg|Arhalofenate 600 mg plus allopurinol 300 mg (Safety Population)
192965|NCT01398943|B2|Baseline|All Controls|Healthy age- and sex- matched controls
192948|NCT01399008|E1|Reported Event|Arhalofenate 400 mg Plus Allopurinol 300 mg|Arhalofenate 400 mg plus allopurinol 300 mg (Safety Population)
192949|NCT01398982|B3|Baseline|Total|Total of all reporting groups
192950|NCT01398982|B2|Baseline|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
192951|NCT01398982|B1|Baseline|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
192952|NCT01398982|P2|Participant Flow|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
192953|NCT01398982|P1|Participant Flow|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
192954|NCT01398982|O2|Outcome|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
192955|NCT01398982|O1|Outcome|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
192956|NCT01398982|E2|Reported Event|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
192957|NCT01398982|E1|Reported Event|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
192958|NCT01398956|B1|Baseline|Levetiracetam|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
192959|NCT01398956|P1|Participant Flow|Levetiracetam|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
192960|NCT01398956|O1|Outcome|Levetiracetam (SS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
192961|NCT01398956|O1|Outcome|Levetiracetam (FAS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
192962|NCT01398956|O1|Outcome|Levetiracetam (SS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
192963|NCT01398956|E1|Reported Event|Levetiracetam (SS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
192964|NCT01398943|B3|Baseline|Total|Total of all reporting groups
192967|NCT01398943|P4|Participant Flow|Controls: Placebo First, Then AOC|"Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) was assessed at baseline and 2 hours following ingestion of microcrystalline cellulose capsules as a placebo.
After a minimum of 2 days washout, subjects returned to perform all measures again but were given an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid."
192968|NCT01398943|P3|Participant Flow|Controls: AOC First, Then Placebo|"Healthy age- and sex- matched controls
Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) were assessed at baseline and 2 hours following ingestion of an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.
After a minimum of 2 days washout, subjects returned to perform all measures again but were given microcrystalline cellulose capsules as a placebo."
192969|NCT01398943|P2|Participant Flow|COPD: Placebo First, Then AOC|"Patients with COPD
Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) was assessed at baseline and 2 hours following ingestion of microcrystalline cellulose capsules as a placebo.
After a minimum of 2 days washout, patients returned to perform all measures again but were given an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid."
192970|NCT01398943|P1|Participant Flow|COPD: AOC First, Then Placebo|"Patients with COPD
Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) were assessed at baseline and 2 hours following ingestion of an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.
After a minimum of 2 days washout, patients returned to perform all measures again but were given microcrystalline cellulose capsules as a placebo."
192971|NCT01398943|O2|Outcome|All Controls|"Healthy age- and sex- matched controls
Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
192972|NCT01398943|O1|Outcome|All COPD Patients|"Patients with COPD
Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
192973|NCT01398943|O2|Outcome|All Controls|Healthy age- and sex- matched controls
192974|NCT01398943|O1|Outcome|All COPD Patients|Patients with COPD
192975|NCT01398943|E2|Reported Event|Controls|"Healthy age- and sex- matched controls
Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
192976|NCT01398943|E1|Reported Event|COPD Patients|"Patients with COPD
Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) will be assessed at baseline and 2 hours following ingestion of a single oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid"
192977|NCT01398852|B1|Baseline|CXL Treatment|All eyes to be treated with riboflavin and UV light
192978|NCT01398852|P1|Participant Flow|CXL Treatment|All eyes to be treated with riboflavin and UV light
192979|NCT01398852|O1|Outcome|CXL Treatment|All eyes to be treated with riboflavin and UV light
192980|NCT01398852|E1|Reported Event|CXL Treatment|All eyes to be treated with riboflavin and UV light
192981|NCT01398839|B3|Baseline|Total|Total of all reporting groups
192982|NCT01398839|B2|Baseline|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
192983|NCT01398839|B1|Baseline|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light
Riboflavin : Both treatment and sham groups will receive riboflavin"
192984|NCT01398839|P2|Participant Flow|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
192985|NCT01398839|P1|Participant Flow|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light
Riboflavin : Both treatment and sham groups will receive riboflavin"
192986|NCT01398839|O2|Outcome|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
192987|NCT01398839|O1|Outcome|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light
Riboflavin : Both treatment and sham groups will receive riboflavin"
192988|NCT01398839|E2|Reported Event|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
192989|NCT01398839|E1|Reported Event|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light
Riboflavin : Both treatment and sham groups will receive riboflavin"
192990|NCT01398787|B1|Baseline|AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS|AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
192991|NCT01398787|P1|Participant Flow|AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS|AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
192992|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
193057|NCT01398176|P1|Participant Flow|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
192993|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
192994|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
192995|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
192996|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
192997|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
192998|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
192999|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
193000|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
193001|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
193002|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
193003|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
193004|NCT01398787|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye, up to 10 minutes each
193005|NCT01398787|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 4 colors (gray, blue, green, pure hazel) worn in one eye, up to 10 minutes each
193006|NCT01398514|B3|Baseline|Total|Total of all reporting groups
193007|NCT01398514|B2|Baseline|Placebo|Matched pill placebo
193008|NCT01398514|B1|Baseline|Active Medication|Escitalopram 10mg/day
193009|NCT01398514|P2|Participant Flow|Placebo|Matched pill placebo
193010|NCT01398514|P1|Participant Flow|Active Medication|Escitalopram 10mg/day
193011|NCT01398514|O4|Outcome|Placebo CS+|
193012|NCT01398514|O3|Outcome|Placebo CS-|
193013|NCT01398514|O2|Outcome|Active Medication CS+|Matched pill placebo
193014|NCT01398514|O1|Outcome|Active Medication CS-|Escitalopram 10mg/day
193015|NCT01398514|O4|Outcome|Placebo CS+|
193016|NCT01398514|O3|Outcome|Placebo CS-|
193017|NCT01398514|O2|Outcome|Active Medication CS+|Matched pill placebo
193018|NCT01398514|O1|Outcome|Active Medication CS-|Escitalopram 10mg/day
193019|NCT01398514|E2|Reported Event|Placebo|Matched pill placebo
193020|NCT01398514|E1|Reported Event|Active Medication|Escitalopram 10mg/day
193021|NCT01398475|B1|Baseline|Entire Study Population|"Includes groups randomized to receive any of the following study drugs as the first intervention.
LY3009104 Reference Formulation (RF): 8-milligram (mg) dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.
LY3009104 Test Formulation 1 (TF1), 20 micrometers (mcm): 8-mg dose of LY3009104 TF1 [one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 mcm] administered once in a fasted state.
LY3009104 Test Formulation 2 (TF2), 50 mcm, fasted: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.
LY3009104 TF2, 50 mcm, fed: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal."
193022|NCT01398475|P4|Participant Flow|LY 50-mcm Fed, LY 50-mcm Fasted, LY RF, LY 20-mcm|"First intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.
Second intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.
Third intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.
Fourth Intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.
There was a washout period of 5 to 7 days between doses of study drug."
193023|NCT01398475|P3|Participant Flow|LY 50-mcm Fasted, LY 20-mcm, LY 50-mcm Fed, LY RF|"First intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.
Second intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.
Third intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.
Fourth intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.
There was a washout period of 5 to 7 days between doses of study drug."
193024|NCT01398475|P2|Participant Flow|LY 20-mcm, LY RF, LY 50-mcm Fasted, LY 50-mcm Fed|"First intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.
Second intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.
Third intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.
Fourth intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.
There was a washout period of 5 to 7 days between doses of study drug."
193058|NCT01398176|O2|Outcome|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
193059|NCT01398176|O1|Outcome|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
193060|NCT01398176|E2|Reported Event|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
193025|NCT01398475|P1|Participant Flow|LY3009104 (LY) RF, LY 50-mcm Fed, LY 20-mcm, LY 50-mcm Fasted|"First intervention: 8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state.
Second intervention: 8-mg dose of LY3009104 test formulation 2 [TF2, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 50 micrometers (mcm)] administered once with a high-fat, high calorie meal.
Third intervention: 8-mg dose of LY3009104 test formulation 1 (TF1, one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.
Fourth intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.
There was a washout period of 5 to 7 days between doses of study drug."
193026|NCT01398475|O4|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
193027|NCT01398475|O3|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 (TF2, one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
193028|NCT01398475|O2|Outcome|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 [TF1, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 micrometers (mcm)] administered once in a fasted state in Period 1, 2, 3, or 4.
193029|NCT01398475|O1|Outcome|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
193030|NCT01398475|O4|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
193031|NCT01398475|O3|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 (TF2, one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
193032|NCT01398475|O2|Outcome|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 [TF1, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 micrometers (mcm)] administered once in a fasted state in Period 1, 2, 3, or 4.
193033|NCT01398475|O1|Outcome|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
193034|NCT01398475|O4|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
193035|NCT01398475|O3|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 (TF2, one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
193036|NCT01398475|O2|Outcome|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 [TF1, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 micrometers (mcm)] administered once in a fasted state in Period 1, 2, 3, or 4.
193037|NCT01398475|O1|Outcome|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
193038|NCT01398475|E4|Reported Event|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
193039|NCT01398475|E3|Reported Event|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 (TF1, one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
193040|NCT01398475|E2|Reported Event|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 [TF2, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 50 micrometer (mcm)] administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
193041|NCT01398475|E1|Reported Event|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
193042|NCT01398410|B3|Baseline|Total|Total of all reporting groups
193043|NCT01398410|B2|Baseline|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
193044|NCT01398410|B1|Baseline|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
193045|NCT01398410|P2|Participant Flow|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
193046|NCT01398410|P1|Participant Flow|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
193047|NCT01398410|O2|Outcome|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
193048|NCT01398410|O1|Outcome|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
193049|NCT01398410|O2|Outcome|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
193050|NCT01398410|O1|Outcome|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
193051|NCT01398410|E2|Reported Event|Rabeprazole10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
193052|NCT01398410|E1|Reported Event|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
193053|NCT01398176|B3|Baseline|Total|Total of all reporting groups
193054|NCT01398176|B2|Baseline|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
193055|NCT01398176|B1|Baseline|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
193056|NCT01398176|P2|Participant Flow|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
193061|NCT01398176|E1|Reported Event|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
193062|NCT01397890|B3|Baseline|Total|Total of all reporting groups
193063|NCT01397890|B2|Baseline|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193064|NCT01397890|B1|Baseline|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193065|NCT01397890|P2|Participant Flow|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193066|NCT01397890|P1|Participant Flow|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193067|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193068|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193069|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193070|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193071|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193072|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193073|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193074|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193075|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193076|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193077|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193078|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193079|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193080|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193081|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193082|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193083|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193084|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193085|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193086|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193087|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193088|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193089|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193090|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193091|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193092|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193093|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193094|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193095|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193096|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193097|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193098|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193099|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193100|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193101|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193102|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193103|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193104|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193105|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193106|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193107|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193108|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193109|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193110|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193111|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193112|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193113|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193114|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193115|NCT01397890|E2|Reported Event|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
193116|NCT01397890|E1|Reported Event|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
193117|NCT01397851|B3|Baseline|Total|Total of all reporting groups
193118|NCT01397851|B2|Baseline|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
193119|NCT01397851|B1|Baseline|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net
Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
193120|NCT01397851|P2|Participant Flow|Treatment|
193121|NCT01397851|P1|Participant Flow|Control|
193122|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
193123|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net
Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
193124|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
193125|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net
Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
193126|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
193127|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net
Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
193128|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
193129|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net
Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
193130|NCT01397851|E2|Reported Event|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
193131|NCT01397851|E1|Reported Event|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net
Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
193132|NCT01397786|B4|Baseline|Total|Total of all reporting groups
193133|NCT01397786|B3|Baseline|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193134|NCT01397786|B2|Baseline|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193135|NCT01397786|B1|Baseline|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193136|NCT01397786|P3|Participant Flow|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193137|NCT01397786|P2|Participant Flow|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193138|NCT01397786|P1|Participant Flow|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786 .
193262|NCT01397409|B10|Baseline|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
193332|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
193139|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193140|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193141|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193142|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193143|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193144|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193145|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193146|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193147|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193148|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193149|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193150|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193151|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193152|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193153|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193154|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193155|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193156|NCT01397786|O3|Outcome|De Novo|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193157|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193158|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193159|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193160|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193161|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193162|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193163|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193164|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193165|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193166|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193167|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193168|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193169|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193170|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193171|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193172|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193173|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193174|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193175|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193176|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193177|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193178|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193179|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193180|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193181|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193182|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193333|NCT01397084|E1|Reported Event|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
193183|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193184|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193185|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193186|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193187|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193188|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193189|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193190|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193191|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193192|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193193|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193194|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193195|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193196|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193197|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193198|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
193199|NCT01397786|E4|Reported Event|De Novo (Phase B)|"Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.
NOTE: Five participants from Phase B - Denovo were excluded in this analysis."
193200|NCT01397786|E3|Reported Event|Prior Placebo (Phase B)|"Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
Participants who received at least 1 dose of study drug were included in this phase.
NOTE: One participant each from the trials P33110230 and P33110231 were excluded in this analysis."
193201|NCT01397786|E2|Reported Event|Prior Brexpiprazole (Phase B)|"Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.
NOTE: Six participants from the trial P33110231 were excluded in this analysis."
193202|NCT01397786|E1|Reported Event|De Novo (Phase A)|"Participants underwent cross-titration to oral brexpiprazole for 4 weeks in Phase A. DeNovo participants in Phase A received brexpiprazole monotherapy starting dose of 2 mg daily at the conversion Week 4 visit (baseline visit of Phase B). Participants who received at least 1 dose of study drug were included in this phase.
NOTE: 12 participants from the trial P33110232 were excluded in this analysis."
193263|NCT01397409|B9|Baseline|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
193203|NCT01397747|B1|Baseline|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
193204|NCT01397747|P1|Participant Flow|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
193205|NCT01397747|O2|Outcome|FIT Test Results|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
193206|NCT01397747|O1|Outcome|Multitarget DNA Test Results|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
193207|NCT01397747|E1|Reported Event|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
193208|NCT01397617|B4|Baseline|Total|Total of all reporting groups
193209|NCT01397617|B3|Baseline|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant
NobelReplace Tapered Groovy implant"
193210|NCT01397617|B2|Baseline|NobelActive External|"NobelActive External implant
NobelActive External implant"
193211|NCT01397617|B1|Baseline|NobelActive Internal|"NobelActive Internal implant
NobelActive Internal implant"
193212|NCT01397617|P3|Participant Flow|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant
NobelReplace Tapered Groovy implant"
193213|NCT01397617|P2|Participant Flow|NobelActive External|"NobelActive External implant
NobelActive External implant"
193214|NCT01397617|P1|Participant Flow|NobelActive Internal|"NobelActive Internal implant
NobelActive Internal implant"
193215|NCT01397617|O3|Outcome|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant
NobelReplace Tapered Groovy implant: Dental implant"
193216|NCT01397617|O2|Outcome|NobelActive External|"NobelActive External implant
NobelActive External implant: Dental implant"
193217|NCT01397617|O1|Outcome|NobelActive Internal|"NobelActive Internal implant
NobelActive Internal implant: Dental implant"
193218|NCT01397617|O3|Outcome|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant
NobelReplace Tapered Groovy implant"
193219|NCT01397617|O2|Outcome|NobelActive Internal|"NobelActive Internal implant
NobelActive Internal implant"
193220|NCT01397617|O1|Outcome|NobelActive External|"NobelActive External implant
NobelActive External implant"
193221|NCT01397617|E3|Reported Event|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant
NobelReplace Tapered Groovy implant"
193222|NCT01397617|E2|Reported Event|NobelActive Internal|"NobelActive Internal implant
NobelActive Internal implant"
193223|NCT01397617|E1|Reported Event|NobelActive External|"NobelActive External implant
NobelActive External implant"
193224|NCT01397591|B1|Baseline|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
193225|NCT01397591|P1|Participant Flow|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
193226|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given IV
laboratory biomarker analysis: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
biopsy: Optional correlative studies
quality-of-life assessment: Ancillary studies
polymorphism analysis: Correlative studies
flow cytometry: Correlative studies"
193227|NCT01397591|O1|Outcome|Ofatumumab in Combination With Bortezomib|"All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
ofatumumab: Given IV
bortezomib: Given IV
laboratory biomarker analysis: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
biopsy: Optional correlative studies
quality-of-life assessment: Ancillary studies
polymorphism analysis: Correlative studies
flow cytometry: Correlative studies"
193228|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given IV
laboratory biomarker analysis: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
biopsy: Optional correlative studies
quality-of-life assessment: Ancillary studies
polymorphism analysis: Correlative studies
flow cytometry: Correlative studies"
193229|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given IV
laboratory biomarker analysis: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
biopsy: Optional correlative studies
quality-of-life assessment: Ancillary studies
polymorphism analysis: Correlative studies
flow cytometry: Correlative studies"
193230|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ofatumumab: Given IV
bortezomib: Given IV
laboratory biomarker analysis: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
biopsy: Optional correlative studies
quality-of-life assessment: Ancillary studies
polymorphism analysis: Correlative studies
flow cytometry: Correlative studies"
193231|NCT01397591|E1|Reported Event|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
193232|NCT01397461|B4|Baseline|Total|Total of all reporting groups
193233|NCT01397461|B3|Baseline|Retapamulin 1% Ointment|"1% ointment
retapamulin 1% ointment: ointment"
193234|NCT01397461|B2|Baseline|Ozenoxacin Placebo|"cream
ozenoxacin placebo: cream"
193235|NCT01397461|B1|Baseline|Ozenoxacin 1% Cream|"1% cream
ozenoxacin 1% cream: 1% cream"
193236|NCT01397461|P3|Participant Flow|Retapamulin 1% Ointment|"1% ointment
retapamulin 1% ointment: ointment"
193237|NCT01397461|P2|Participant Flow|Ozenoxacin Placebo|"cream
ozenoxacin placebo: cream"
193238|NCT01397461|P1|Participant Flow|Ozenoxacin 1% Cream|"1% cream
ozenoxacin 1% cream: 1% cream"
193239|NCT01397461|O3|Outcome|Retapamulin 1% Ointment|"1% ointment
retapamulin 1% ointment: ointment"
193240|NCT01397461|O2|Outcome|Ozenoxacin Placebo|"cream
ozenoxacin placebo: cream"
193241|NCT01397461|O1|Outcome|Ozenoxacin 1% Cream|"1% cream
ozenoxacin 1% cream: 1% cream"
193242|NCT01397461|E3|Reported Event|Retapamulin 1% Ointment|"1% ointment
retapamulin 1% ointment: ointment"
193243|NCT01397461|E2|Reported Event|Ozenoxacin Placebo|"cream
ozenoxacin placebo: cream"
193244|NCT01397461|E1|Reported Event|Ozenoxacin 1% Cream|"1% cream
ozenoxacin 1% cream: 1% cream"
193245|NCT01397448|B4|Baseline|Total|Total of all reporting groups
193246|NCT01397448|B3|Baseline|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
193247|NCT01397448|B2|Baseline|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
193248|NCT01397448|B1|Baseline|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
193249|NCT01397448|P3|Participant Flow|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
193250|NCT01397448|P2|Participant Flow|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
193251|NCT01397448|P1|Participant Flow|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
193252|NCT01397448|O3|Outcome|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
193253|NCT01397448|O2|Outcome|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
193254|NCT01397448|O1|Outcome|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
193255|NCT01397448|O3|Outcome|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
193256|NCT01397448|O2|Outcome|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
193257|NCT01397448|O1|Outcome|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
193258|NCT01397448|E3|Reported Event|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
193259|NCT01397448|E2|Reported Event|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
193260|NCT01397448|E1|Reported Event|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
193261|NCT01397409|B11|Baseline|Total|Total of all reporting groups
193327|NCT01397084|B1|Baseline|Esomeprazole 20 mg|esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
193264|NCT01397409|B8|Baseline|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
193265|NCT01397409|B7|Baseline|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193266|NCT01397409|B6|Baseline|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193267|NCT01397409|B5|Baseline|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193268|NCT01397409|B4|Baseline|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
193269|NCT01397409|B3|Baseline|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
193270|NCT01397409|B2|Baseline|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
193271|NCT01397409|B1|Baseline|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
193272|NCT01397409|P10|Participant Flow|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
193273|NCT01397409|P9|Participant Flow|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
193274|NCT01397409|P8|Participant Flow|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
193275|NCT01397409|P7|Participant Flow|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193276|NCT01397409|P6|Participant Flow|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193277|NCT01397409|P5|Participant Flow|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193278|NCT01397409|P4|Participant Flow|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
193279|NCT01397409|P3|Participant Flow|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
193280|NCT01397409|P2|Participant Flow|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
193281|NCT01397409|P1|Participant Flow|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
193282|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
193283|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
193284|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
193285|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
193286|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
193287|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
193288|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193289|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193290|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193291|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193292|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193293|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193294|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193295|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193296|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193297|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
193298|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
193299|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
193328|NCT01397084|P1|Participant Flow|Esomeprazole 20 mg|esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
193300|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193301|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193302|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193303|NCT01397409|O4|Outcome|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
193304|NCT01397409|O3|Outcome|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
193305|NCT01397409|O2|Outcome|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
193306|NCT01397409|O1|Outcome|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
193307|NCT01397409|O1|Outcome|Stage 1 All Participants|Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
193308|NCT01397409|E10|Reported Event|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
193309|NCT01397409|E9|Reported Event|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
193310|NCT01397409|E8|Reported Event|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
193311|NCT01397409|E7|Reported Event|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193312|NCT01397409|E6|Reported Event|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193313|NCT01397409|E5|Reported Event|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
193314|NCT01397409|E4|Reported Event|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
193315|NCT01397409|E3|Reported Event|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
193316|NCT01397409|E2|Reported Event|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
193317|NCT01397409|E1|Reported Event|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
193318|NCT01397253|B3|Baseline|Total|Total of all reporting groups
193319|NCT01397253|B2|Baseline|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.
Automated communication tools will include:
PCP notification of patient admission and location
Data on medications begun on admission
Automated alerts on changes in patient status and location while the patient is hospitalized
Links to the EMR and to hospital physician contact information on all email alerts
Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP
Automatic reporting to PCPs of test results pending at discharge
Electronic delivery of final discharge summaries"
193320|NCT01397253|B1|Baseline|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
193321|NCT01397253|P2|Participant Flow|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.
Automated communication tools will include:
PCP notification of patient admission and location
Data on medications begun on admission
Automated alerts on changes in patient status and location while the patient is hospitalized
Links to the EMR and to hospital physician contact information on all email alerts
Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP
Automatic reporting to PCPs of test results pending at discharge
Electronic delivery of final discharge summaries"
193322|NCT01397253|P1|Participant Flow|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
193323|NCT01397253|O2|Outcome|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.
Automated communication tools will include:
PCP notification of patient admission and location
Data on medications begun on admission
Automated alerts on changes in patient status and location while the patient is hospitalized
Links to the EMR and to hospital physician contact information on all email alerts
Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP
Automatic reporting to PCPs of test results pending at discharge
Electronic delivery of final discharge summaries"
193324|NCT01397253|O1|Outcome|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
193325|NCT01397253|E2|Reported Event|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.
Automated communication tools will include:
PCP notification of patient admission and location
Data on medications begun on admission
Automated alerts on changes in patient status and location while the patient is hospitalized
Links to the EMR and to hospital physician contact information on all email alerts
Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP
Automatic reporting to PCPs of test results pending at discharge
Electronic delivery of final discharge summaries"
193326|NCT01397253|E1|Reported Event|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
193334|NCT01396525|B1|Baseline|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193335|NCT01396525|P1|Participant Flow|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193336|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193337|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193338|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193339|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193340|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193341|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193342|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193343|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193344|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193345|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193346|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193347|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193348|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193349|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193350|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193351|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193352|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193353|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193354|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193486|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193355|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193356|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193357|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193358|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193359|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193360|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193361|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193362|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193363|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193364|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193365|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193366|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193367|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193368|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193369|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193370|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193371|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193372|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193373|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193374|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193375|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193802|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
193376|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193377|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193378|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193379|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193380|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193381|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193382|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193383|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193384|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193385|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193386|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193387|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193388|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193389|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193390|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193391|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193392|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193393|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193394|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193395|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193396|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193852|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193397|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193398|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193399|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193400|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193401|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193402|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193403|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193404|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193405|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193406|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193407|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193408|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193409|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193410|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193411|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193412|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193413|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193414|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193415|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193416|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193417|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193418|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193419|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193420|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193421|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193422|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193423|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193424|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193425|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193426|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193427|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193428|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193429|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193430|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193431|NCT01396525|E1|Reported Event|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
193432|NCT01396512|B3|Baseline|Total|Total of all reporting groups
193433|NCT01396512|B2|Baseline|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
193434|NCT01396512|B1|Baseline|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
193435|NCT01396512|P2|Participant Flow|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
193436|NCT01396512|P1|Participant Flow|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
193437|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
193438|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
193439|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
193440|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
193441|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
193442|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
193443|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
193444|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
193445|NCT01396512|E2|Reported Event|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
193446|NCT01396512|E1|Reported Event|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
193447|NCT01396434|B4|Baseline|Total|Total of all reporting groups
193448|NCT01396434|B3|Baseline|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
193449|NCT01396434|B2|Baseline|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
193450|NCT01396434|B1|Baseline|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
193451|NCT01396434|P3|Participant Flow|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
193909|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
193452|NCT01396434|P2|Participant Flow|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
193453|NCT01396434|P1|Participant Flow|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
193454|NCT01396434|O3|Outcome|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
193455|NCT01396434|O2|Outcome|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
193456|NCT01396434|O1|Outcome|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
193457|NCT01396434|E3|Reported Event|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
193458|NCT01396434|E2|Reported Event|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
193459|NCT01396434|E1|Reported Event|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
193460|NCT01396421|B5|Baseline|Total|Total of all reporting groups
193461|NCT01396421|B4|Baseline|Placebo|Placebo tablet once daily for 6 weeks.
193462|NCT01396421|B3|Baseline|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193463|NCT01396421|B2|Baseline|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193464|NCT01396421|B1|Baseline|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193465|NCT01396421|P4|Participant Flow|Placebo|Placebo tablet once daily for 6 weeks.
193466|NCT01396421|P3|Participant Flow|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193467|NCT01396421|P2|Participant Flow|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193468|NCT01396421|P1|Participant Flow|Brexpiprazole 4 mg|"Brexpiprazole 4 milligram (mg) tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193469|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193470|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193471|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193472|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193473|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks
193474|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193475|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of placebo over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193476|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193477|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193478|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193479|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193480|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193481|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193482|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193483|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193484|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193485|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193487|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193488|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193489|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193490|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193491|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193492|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193493|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193494|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193495|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day by Day 5."
193496|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193497|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193498|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193499|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193500|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193501|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193502|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193503|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193504|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2"
193505|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193506|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193507|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193508|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193509|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193510|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193511|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193512|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193513|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193514|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193515|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a r5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193516|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193517|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193518|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193519|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193910|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
193520|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193521|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193522|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193523|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5)."
193524|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1),and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193525|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193526|NCT01396421|O3|Outcome|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193527|NCT01396421|O2|Outcome|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193528|NCT01396421|O1|Outcome|Brexpiprazole 4 mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193529|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
193530|NCT01396421|O3|Outcome|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks
193531|NCT01396421|O2|Outcome|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193532|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1),and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193533|NCT01396421|E4|Reported Event|Placebo|Placebo tablet once daily for 6 weeks.
193534|NCT01396421|E3|Reported Event|Brexpiprazile 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
193535|NCT01396421|E2|Reported Event|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
193536|NCT01396421|E1|Reported Event|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.
Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
193537|NCT01396395|B3|Baseline|Total|Total of all reporting groups
193538|NCT01396395|B2|Baseline|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193539|NCT01396395|B1|Baseline|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193540|NCT01396395|P2|Participant Flow|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193541|NCT01396395|P1|Participant Flow|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 milligram (mg) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors (ACEIs) as permitted by disease condition or as per standard local practices or prescribed per discretion of the investigators.
193542|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193543|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193544|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193545|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193546|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193911|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
193547|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193548|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193549|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193550|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193551|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193552|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193553|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193554|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193555|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193556|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193557|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193558|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193559|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193560|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193561|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193562|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193563|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193564|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193565|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193598|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
193599|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193566|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193567|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193568|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193569|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193570|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193571|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193572|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193573|NCT01396395|E2|Reported Event|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
193574|NCT01396395|E1|Reported Event|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
193575|NCT01396382|B1|Baseline|Imaging/Scans|68Ga-DOTATATE PET scans performed on subjects. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
193576|NCT01396382|P1|Participant Flow|68Ga-DOTATATE PET Scan|68Ga-DOTATATE PET scans performed on subjects. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
193577|NCT01396382|O1|Outcome|68Ga-DOTATATE PET|68Ga-DOTATATE will be administered to patient in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
193578|NCT01396382|O1|Outcome|68Ga-DOTATATE PET|68Ga-DOTATATE PET scan will be administered to patients in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
193579|NCT01396382|E1|Reported Event|68Ga-DOTATATE PET Scan|Patients will receive 68Ga-DOTATATE PET scans. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
193580|NCT01396265|B1|Baseline|Overall Study|This was a open-label, two period, fixed sequence trial clinical phase I trial in healthy male volunteers.
193581|NCT01396265|P1|Participant Flow|Overall Group|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193582|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
193583|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193584|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
193585|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193586|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
193587|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193588|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
193589|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193590|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
193591|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193592|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
193593|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193594|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
193595|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193596|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
193597|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193600|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
193601|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193602|NCT01396265|E2|Reported Event|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
193603|NCT01396265|E1|Reported Event|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
193604|NCT01396239|B4|Baseline|Total|Total of all reporting groups
193605|NCT01396239|B3|Baseline|Placebo|Placebo: phosphate buffered saline solution identical in appearance to eteplirsen for 24 weeks
193606|NCT01396239|B2|Baseline|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen for 24 weeks
193607|NCT01396239|B1|Baseline|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen for 24 weeks
193608|NCT01396239|P4|Participant Flow|Placebo - Week 24 Biopsy|Placebo for 24 weeks with muscle biopsy at Week 24
193609|NCT01396239|P3|Participant Flow|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen for 24 weeks
193610|NCT01396239|P2|Participant Flow|Placebo - Week 12 Biopsy|Placebo for 24 Weeks with muscle Biopsy at Week 12
193611|NCT01396239|P1|Participant Flow|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen for 24 weeks
193612|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
193613|NCT01396239|O2|Outcome|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
193614|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
193615|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
193616|NCT01396239|O2|Outcome|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
193617|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
193618|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks
193619|NCT01396239|O2|Outcome|50mg/kg Eteplirsen|50mg/kg eteplirsen for 24 weeks
193620|NCT01396239|O1|Outcome|30mg/kg Eteplirsen|30mg/kg eteplirsen for 24 weeks
193621|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks
193622|NCT01396239|O2|Outcome|50 mg/kg Eteplirsen|50 mg/kg eteplirsen for 24 weeks
193623|NCT01396239|O1|Outcome|30 mg/kg Eteplirsen|30 mg/kg eteplirsen for 24 weeks
193624|NCT01396239|O4|Outcome|Placebo - Week 12 Biopsy|Placebo - Biopsied after 12 weeks of dosing
193625|NCT01396239|O3|Outcome|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen - Biopsied after 12 weeks of dosing
193626|NCT01396239|O2|Outcome|Placebo - Week 24 Biopsy|Placebo: Biopsied after 24 weeks of dosing
193627|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen - Biopsied after 24 weeks of dosing
193628|NCT01396239|E3|Reported Event|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
193629|NCT01396239|E2|Reported Event|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
193630|NCT01396239|E1|Reported Event|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
193631|NCT01396226|B3|Baseline|Total|Total of all reporting groups
193632|NCT01396226|B2|Baseline|PLACEBO|Placebo solution for infusion
193633|NCT01396226|B1|Baseline|AZD2927|AZD2927 solution for infusion
193634|NCT01396226|P2|Participant Flow|PLACEBO|Placebo solution for infusion
193635|NCT01396226|P1|Participant Flow|AZD2927|AZD2927 solution for infusion
193636|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193637|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193638|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193639|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193640|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193641|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193642|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193643|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193644|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193645|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193646|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193647|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193648|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193649|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193650|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193651|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193652|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193653|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193654|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193655|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193656|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193657|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193658|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193659|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193660|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
193661|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
193662|NCT01396226|E2|Reported Event|PLACEBO|Placebo solution for infusion
193663|NCT01396226|E1|Reported Event|AZD2927|AZD2927 solution for infusion
193665|NCT01396187|B5|Baseline|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193666|NCT01396187|B4|Baseline|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193667|NCT01396187|B3|Baseline|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193668|NCT01396187|B2|Baseline|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193669|NCT01396187|B1|Baseline|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193670|NCT01396187|P5|Participant Flow|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193671|NCT01396187|P4|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193672|NCT01396187|P3|Participant Flow|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193673|NCT01396187|P2|Participant Flow|PF-05231023 5 mg|PF-05231023 5 mg (milligram) intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193674|NCT01396187|P1|Participant Flow|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193675|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193676|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193677|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193678|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193679|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193680|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193681|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193682|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193683|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193684|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193685|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193686|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193687|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193688|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193689|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193690|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193691|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193692|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193693|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193694|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193695|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193696|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193697|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193698|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193699|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193700|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193701|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193702|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193703|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193704|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193705|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193706|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193707|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193708|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193709|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193710|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193711|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193712|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193713|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193714|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193715|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193716|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193717|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193718|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193719|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193720|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193721|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193722|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193723|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193724|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193725|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193726|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193727|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193728|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193729|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193730|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193731|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193732|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193733|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193734|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193735|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193736|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193737|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193738|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193739|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193740|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193741|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193742|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193743|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193744|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193745|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193746|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193747|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193748|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193749|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193750|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193751|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193752|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193753|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193754|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193755|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193756|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193757|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193758|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193759|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193760|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193761|NCT01396187|E5|Reported Event|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193762|NCT01396187|E4|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193763|NCT01396187|E3|Reported Event|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
193764|NCT01396187|E2|Reported Event|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193765|NCT01396187|E1|Reported Event|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
193766|NCT01396161|B8|Baseline|Total|Total of all reporting groups
193767|NCT01396161|B7|Baseline|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193768|NCT01396161|B6|Baseline|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
193769|NCT01396161|B5|Baseline|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules PF-05175157 QD for 14 days
193770|NCT01396161|B4|Baseline|PF-05175157 100 mg QD -HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
193771|NCT01396161|B3|Baseline|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
193772|NCT01396161|B2|Baseline|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
193773|NCT01396161|B1|Baseline|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
193774|NCT01396161|P7|Participant Flow|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193775|NCT01396161|P6|Participant Flow|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 twice daily (BID) for 14 days
193776|NCT01396161|P5|Participant Flow|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193777|NCT01396161|P4|Participant Flow|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
193778|NCT01396161|P3|Participant Flow|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 milligram (mg) capsules of PF-05175157 QD for 14 days
193779|NCT01396161|P2|Participant Flow|Placebo - Type 2 Diabetes Mellitus Participants (T2DM)|T2DM participants administered orally matched placebo capsules QD for 14 days
193780|NCT01396161|P1|Participant Flow|Placebo - Healthy and Overweight Participants (HOV)|HOV participants administered orally matched placebo capsules once daily (QD) for 14 days
193781|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193782|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
193783|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193784|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
193785|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
193786|NCT01396161|O7|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193787|NCT01396161|O6|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
193788|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193789|NCT01396161|O4|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
193790|NCT01396161|O3|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
193791|NCT01396161|O2|Outcome|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
193792|NCT01396161|O1|Outcome|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
193793|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193794|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
193795|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193796|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
193797|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
193798|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193799|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
193800|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193801|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
193803|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193804|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
193805|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193806|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
193807|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
193808|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193809|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
193810|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193811|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
193812|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
193813|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193814|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
193815|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193816|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
193817|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
193818|NCT01396161|O7|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193819|NCT01396161|O6|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
193820|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193821|NCT01396161|O4|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
193822|NCT01396161|O3|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
193823|NCT01396161|O2|Outcome|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
193824|NCT01396161|O1|Outcome|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
193825|NCT01396161|E7|Reported Event|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193826|NCT01396161|E6|Reported Event|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
193827|NCT01396161|E5|Reported Event|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
193828|NCT01396161|E4|Reported Event|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
193829|NCT01396161|E3|Reported Event|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
193830|NCT01396161|E2|Reported Event|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
193831|NCT01396161|E1|Reported Event|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
193832|NCT01396083|B3|Baseline|Total|Total of all reporting groups
193833|NCT01396083|B2|Baseline|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193834|NCT01396083|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193835|NCT01396083|P2|Participant Flow|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193836|NCT01396083|P1|Participant Flow|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193837|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193838|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193839|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193840|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193841|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193842|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193843|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193844|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193845|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193846|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193847|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193848|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193849|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193850|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193851|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193853|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193854|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193855|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193856|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193857|NCT01396083|E2|Reported Event|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193858|NCT01396083|E1|Reported Event|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193859|NCT01396070|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
193860|NCT01396070|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
193861|NCT01396070|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
193862|NCT01396070|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
193863|NCT01396070|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
193864|NCT01396070|O1|Outcome|Overall Response Rate (%)|Overall Response Rate of all patients
193865|NCT01396070|E1|Reported Event|All Participants|All reported AE's on trial
193866|NCT01396057|B3|Baseline|Total|Total of all reporting groups
193867|NCT01396057|B2|Baseline|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193868|NCT01396057|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193869|NCT01396057|P2|Participant Flow|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193870|NCT01396057|P1|Participant Flow|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193871|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193872|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193873|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193874|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193875|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193876|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193877|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193878|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193879|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193880|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193881|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193882|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193883|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193884|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193885|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193886|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193887|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193888|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193889|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193890|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193891|NCT01396057|E2|Reported Event|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
193892|NCT01396057|E1|Reported Event|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
193893|NCT01396044|B3|Baseline|Total|Total of all reporting groups
193894|NCT01396044|B2|Baseline|Verbal Prompting|Verbal prompting with written checklist
193895|NCT01396044|B1|Baseline|Electronic Checklist|Electronic checklist
193896|NCT01396044|P2|Participant Flow|Verbal Prompting|Verbal prompting with written checklist
193897|NCT01396044|P1|Participant Flow|Electronic Checklist|Electronic checklist
193898|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
193899|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
193900|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
193901|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
193902|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
193903|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
193904|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
193905|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
193906|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
193907|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
193908|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
193912|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
193913|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
193914|NCT01396044|E2|Reported Event|Verbal Prompting|Verbal prompting with written checklist
193915|NCT01396044|E1|Reported Event|Electronic Checklist|Electronic checklist
193916|NCT01396005|B3|Baseline|Total|Total of all reporting groups
193917|NCT01396005|B2|Baseline|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
193918|NCT01396005|B1|Baseline|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
193919|NCT01396005|P2|Participant Flow|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
193920|NCT01396005|P1|Participant Flow|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
193921|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
193922|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
193923|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
193924|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
193925|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
193926|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
193927|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
193928|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
193929|NCT01396005|O2|Outcome|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
193930|NCT01396005|O1|Outcome|Methadone Alone|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
193931|NCT01396005|O2|Outcome|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
193932|NCT01396005|O1|Outcome|Methadone Alone|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
193933|NCT01396005|E2|Reported Event|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
193934|NCT01396005|E1|Reported Event|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
193935|NCT01395966|B4|Baseline|Total|Total of all reporting groups
193936|NCT01395966|B3|Baseline|DF289 Plus DF277|"Ear drops
DF289 plus DF277: Ear drops"
193937|NCT01395966|B2|Baseline|DF277|"Ear drops
DF277: Ear drops"
193938|NCT01395966|B1|Baseline|DF289|"Ear drops
DF289: Ear drops"
193939|NCT01395966|P3|Participant Flow|DF289 Plus DF277|"Ear drops
DF289 plus DF277: Ear drops"
193940|NCT01395966|P2|Participant Flow|DF277|"Ear drops
DF277: Ear drops"
193941|NCT01395966|P1|Participant Flow|DF289|"Ear drops
DF289: Ear drops"
193942|NCT01395966|O3|Outcome|DF289 Plus DF277|"Ear drops
DF289 plus DF277: Ear drops"
193943|NCT01395966|O2|Outcome|DF277|"Ear drops
DF277: Ear drops"
193944|NCT01395966|O1|Outcome|DF289|"Ear drops
DF289: Ear drops"
193945|NCT01395966|E3|Reported Event|DF289 Plus DF277|"Ear drops
DF289 plus DF277: Ear drops"
193946|NCT01395966|E2|Reported Event|DF277|"Ear drops
DF277: Ear drops"
193947|NCT01395966|E1|Reported Event|DF289|"Ear drops
DF289: Ear drops"
193948|NCT01395914|B3|Baseline|Total|Total of all reporting groups
193949|NCT01395914|B2|Baseline|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193950|NCT01395914|B1|Baseline|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193951|NCT01395914|P2|Participant Flow|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193952|NCT01395914|P1|Participant Flow|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193953|NCT01395914|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193954|NCT01395914|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193955|NCT01395914|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193956|NCT01395914|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193957|NCT01395914|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193958|NCT01395914|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193959|NCT01395914|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193960|NCT01395914|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193961|NCT01395914|E2|Reported Event|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193962|NCT01395914|E1|Reported Event|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
193963|NCT01395901|B3|Baseline|Total|Total of all reporting groups
193964|NCT01395901|B2|Baseline|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;
13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron"
193965|NCT01395901|B1|Baseline|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron"
193966|NCT01395901|P2|Participant Flow|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;
13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron"
193967|NCT01395901|P1|Participant Flow|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron"
193968|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;
13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron"
193969|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron"
193970|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;
13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron"
193971|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron"
193972|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;
13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron"
193973|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron"
193974|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;
13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron"
193975|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron"
193976|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;
13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron"
193977|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron"
193978|NCT01395901|E2|Reported Event|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron
Ondansetron: Single dose Ondansetron IV:
0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;
13 years to less than 17 years dose: 4 mg
Placebo to Palonosetron"
193979|NCT01395901|E1|Reported Event|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron
Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Placebo to Ondansetron"
193980|NCT01395888|B3|Baseline|Total|Total of all reporting groups
193981|NCT01395888|B2|Baseline|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
194014|NCT01395797|O4|Outcome|Placebo - Nicotine|Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of nicotine.
194015|NCT01395797|O3|Outcome|Pio High Dose - Heroin|Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of heroin.
193982|NCT01395888|B1|Baseline|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
193983|NCT01395888|P3|Participant Flow|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
193984|NCT01395888|P2|Participant Flow|FF/VI 100/25 µg|Participants (par.) self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
193985|NCT01395888|P1|Participant Flow|Salb/Alb + IBr|Participants were provided with an inhaled short-acting beta2-receptor agonist, salbutamol/albuterol (Salb/Alb), for use as needed throughout the Run-in Period for relief of chronic obstructive pulmonary disease (COPD) symptoms. Ipratropium bromide (IBr) was permitted during the Run-in Period and for up to 4 hours prior to Randomization (Visit 2) if the participant was on a stable dose prior to Screening (Visit 1). Following randomization, IBr was not permitted during exposure to study treatment.
193986|NCT01395888|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
193987|NCT01395888|O1|Outcome|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
193988|NCT01395888|E2|Reported Event|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
193989|NCT01395888|E1|Reported Event|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
193990|NCT01395823|B3|Baseline|Total|Total of all reporting groups
193991|NCT01395823|B2|Baseline|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
193992|NCT01395823|B1|Baseline|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
193993|NCT01395823|P2|Participant Flow|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
193994|NCT01395823|P1|Participant Flow|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
193995|NCT01395823|O2|Outcome|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
193996|NCT01395823|O1|Outcome|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
193997|NCT01395823|E2|Reported Event|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
193998|NCT01395823|E1|Reported Event|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
193999|NCT01395797|B7|Baseline|Total|Total of all reporting groups
194000|NCT01395797|B6|Baseline|Pio High Dose - Nicotine|"High dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194001|NCT01395797|B5|Baseline|Pio Low Dose - Nicotine|"Low dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194002|NCT01395797|B4|Baseline|Placebo - Nicotine|"Control condition for active arms.
Pioglitazone: 0, 15, and 45 mg per day."
194003|NCT01395797|B3|Baseline|Pio High Dose - Heroin|"High dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194004|NCT01395797|B2|Baseline|Pio Low Dose - Heroin|"Low dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194005|NCT01395797|B1|Baseline|Placebo - Heroin|"Control condition for active arms.
Placebo: Placebo - Heroin"
194006|NCT01395797|P6|Participant Flow|Pio High Dose - Nicotine|"High dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194007|NCT01395797|P5|Participant Flow|Pio Low Dose - Nicotine|"Low dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194008|NCT01395797|P4|Participant Flow|Placebo - Nicotine|"Control condition for active arms.
Pioglitazone: 0, 15, and 45 mg per day."
194009|NCT01395797|P3|Participant Flow|Pio High Dose - Heroin|"High dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194010|NCT01395797|P2|Participant Flow|Pio Low Dose - Heroin|"Low dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194011|NCT01395797|P1|Participant Flow|Placebo - Heroin|"Control condition for active arms.
Placebo: Placebo - Heroin"
194012|NCT01395797|O6|Outcome|Pio High Dose - Nicotine|Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of nicotine
194013|NCT01395797|O5|Outcome|Pio Low Dose- Nicotine|Participants will be maintained on 15 mg of PIO prior to assessing the abuse liability of nicotine.
194016|NCT01395797|O2|Outcome|Pio Low Dose- Heroin|Participants will be maintained on 15 mg of PIO prior to assessing the abuse liability of heroin.
194017|NCT01395797|O1|Outcome|Placebo - Heroin|"Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of heroin.
Placebo: Placebo"
194018|NCT01395797|O6|Outcome|Pio High Dose - Nicotine|"High dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194019|NCT01395797|O5|Outcome|Pio Low Dose- Nicotine|Low dose Pio comparator.
194020|NCT01395797|O4|Outcome|Placebo - Nicotine|"Control condition for active arms.
Pioglitazone: 0, 15, and 45 mg per day."
194021|NCT01395797|O3|Outcome|Pio High Dose - Heroin|"High dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194022|NCT01395797|O2|Outcome|Pio Low Dose- Heroin|Low dose of Pio comparator
194023|NCT01395797|O1|Outcome|Placebo - Heroin|"Control condition for active arms.
Placebo: Placebo - Heroin"
194024|NCT01395797|E6|Reported Event|Pio High Dose - Nicotine|"High dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194025|NCT01395797|E5|Reported Event|Pio Low Dose - Nicotine|"Low dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194026|NCT01395797|E4|Reported Event|Placebo - Nicotine|"Control condition for active arms.
Pioglitazone: 0, 15, and 45 mg per day."
194027|NCT01395797|E3|Reported Event|Pio High Dose - Heroin|"High dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194028|NCT01395797|E2|Reported Event|Pio Low Dose - Heroin|"Low dose pio comparator.
Pioglitazone: 0, 15, and 45 mg per day."
194029|NCT01395797|E1|Reported Event|Placebo - Heroin|"Control condition for active arms.
Placebo: Placebo - Heroin"
194030|NCT01395784|B1|Baseline|Withing-subjects, Placebo-Controlled|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
194031|NCT01395784|P1|Participant Flow|Withing-subjects, Placebo-Controlled|"Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
pioglitazone: A PPARγ agonist, also marketed as Actos."
194032|NCT01395784|O1|Outcome|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
194033|NCT01395784|O1|Outcome|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
194034|NCT01395784|E1|Reported Event|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
194035|NCT01395524|B4|Baseline|Total|Total of all reporting groups
194036|NCT01395524|B3|Baseline|Placebo|Placebo QD, oral treatment
194037|NCT01395524|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
194038|NCT01395524|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
194039|NCT01395524|P3|Participant Flow|Placebo|Placebo QD, oral treatment
194040|NCT01395524|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
194041|NCT01395524|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
194042|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
194043|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
194044|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
194045|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
194046|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
194047|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
194048|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
194049|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
194050|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
194051|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
194052|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
194053|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
194054|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
194055|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
194056|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
194057|NCT01395524|E3|Reported Event|Placebo|
194058|NCT01395524|E2|Reported Event|NKTR-118 25 mg|
194059|NCT01395524|E1|Reported Event|NKTR-118 12.5 mg|
194060|NCT01395394|B4|Baseline|Total|Total of all reporting groups
194061|NCT01395394|B3|Baseline|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194062|NCT01395394|B2|Baseline|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194063|NCT01395394|B1|Baseline|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.
Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194064|NCT01395394|P3|Participant Flow|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194530|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194065|NCT01395394|P2|Participant Flow|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194066|NCT01395394|P1|Participant Flow|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.
Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194067|NCT01395394|O3|Outcome|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194068|NCT01395394|O2|Outcome|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194069|NCT01395394|O1|Outcome|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.
Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194070|NCT01395394|O3|Outcome|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194071|NCT01395394|O2|Outcome|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194072|NCT01395394|O1|Outcome|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.
Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194073|NCT01395394|E3|Reported Event|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194074|NCT01395394|E2|Reported Event|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194075|NCT01395394|E1|Reported Event|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.
Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.
Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
194076|NCT01395368|B1|Baseline|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
194077|NCT01395368|P1|Participant Flow|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
194078|NCT01395368|O1|Outcome|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
194079|NCT01395368|E1|Reported Event|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
194080|NCT01395277|B3|Baseline|Total|Total of all reporting groups
194133|NCT01394978|P2|Participant Flow|ProGEL Pleural Air Leak Sealant|"Standard surgical technique plus Progel Pleural Air Leak Sealant.
ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG)."
194134|NCT01394978|P1|Participant Flow|Control|"No treatment.
Control: Standard surgical techniques including staples and sutures."
194531|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194081|NCT01395277|B2|Baseline|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with low flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with high flavanol content.
During the first visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
194082|NCT01395277|B1|Baseline|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with high flavanol content . On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with low flavanol content.
During the first visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the placebo trial (low flavanol group) will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
194083|NCT01395277|P2|Participant Flow|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with low flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with high flavanol content.
During the first visit the low flavanol measures will be performed before and 2 hours following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
194084|NCT01395277|P1|Participant Flow|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with high flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with low flavanol content.
During the first visit the high flavanol measures will be performed before and 2 hours following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
194085|NCT01395277|O2|Outcome|Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with low flavanol content, and 2) before and 2 hours following consumption of a beverage with high flavanol content.
The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The hihg flavanol measures will be performed following consumption of a beverage containing 1,0500 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
194086|NCT01395277|O1|Outcome|High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content, and 2) before and 2 hours following consumption of a beverage with low flavanol content.
The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
194087|NCT01395277|O2|Outcome|Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with low flavanol content (placebo trial).
Placebo Trial: CocoaVia Dark Chocolate Flavored Drink: The placebo trial (low flavanol content) will be performed following consumption of a beverage containing 75 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
194088|NCT01395277|O1|Outcome|High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with low flavanol content (placebo trial).
CocoaVia Dark Chocolate Flavored Drink: The experimental trial (high flavanol group) will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
194089|NCT01395277|E2|Reported Event|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with low flavanol content, and 2) before and 2 hours following consumption of a beverage with high flavanol content.
The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
194532|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194090|NCT01395277|E1|Reported Event|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content, and 2) before and 2 hours following consumption of a beverage with low flavanol content.
The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
194091|NCT01395043|B1|Baseline|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
194092|NCT01395043|P1|Participant Flow|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
194093|NCT01395043|O1|Outcome|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters.
194094|NCT01395043|O1|Outcome|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2,5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
194095|NCT01395043|E1|Reported Event|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
194096|NCT01395017|B3|Baseline|Total|Total of all reporting groups
194097|NCT01395017|B2|Baseline|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
194098|NCT01395017|B1|Baseline|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.
194099|NCT01395017|P2|Participant Flow|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
194100|NCT01395017|P1|Participant Flow|Dasatinib + GEM|GEM 1000 mg/m2 by intravenous (IV) infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth once daily (QD).
194101|NCT01395017|O2|Outcome|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
194102|NCT01395017|O1|Outcome|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.
194103|NCT01395017|O2|Outcome|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
194104|NCT01395017|O1|Outcome|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD
194105|NCT01395017|E2|Reported Event|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
194106|NCT01395017|E1|Reported Event|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD
194107|NCT01394991|B3|Baseline|Total|Total of all reporting groups
194108|NCT01394991|B2|Baseline|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
194109|NCT01394991|B1|Baseline|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
194110|NCT01394991|P2|Participant Flow|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
194111|NCT01394991|P1|Participant Flow|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
194112|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
194113|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
194114|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
194115|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
194116|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
194117|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
194118|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
194119|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
194120|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
194121|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
194122|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
194123|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
194124|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
194125|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
194126|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
194127|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
194128|NCT01394991|E2|Reported Event|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
194129|NCT01394991|E1|Reported Event|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
194130|NCT01394978|B3|Baseline|Total|Total of all reporting groups
194131|NCT01394978|B2|Baseline|ProGEL Pleural Air Leak Sealant|"Standard surgical technique plus Progel Pleural Air Leak Sealant.
ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG)."
194132|NCT01394978|B1|Baseline|Control|"No treatment.
Control: Standard surgical techniques including staples and sutures."
194418|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
194135|NCT01394978|O2|Outcome|ProGEL Pleural Air Leak Sealant|"Standard surgical technique plus Progel Pleural Air Leak Sealant.
ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG)."
194136|NCT01394978|O1|Outcome|Control|"No treatment.
Control: Standard surgical techniques including staples and sutures."
194137|NCT01394978|E2|Reported Event|ProGEL Pleural Air Leak Sealant|"Standard surgical technique plus Progel Pleural Air Leak Sealant.
ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG)."
194138|NCT01394978|E1|Reported Event|Control|"No treatment.
Control: Standard surgical techniques including staples and sutures."
194139|NCT01394926|B1|Baseline|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
194140|NCT01394926|P1|Participant Flow|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
194141|NCT01394926|O3|Outcome|Dose Level 3: 1.5mL Optison 8 Minutes|Dose Level 3: Injection of 1.5mL of Optison 8 minutes post dose level 2.
194142|NCT01394926|O2|Outcome|Dose Level 2: 0.5mL Optison at Time 6.5 Minutes|Dose Level 2: Injection given of 0.5mL of Optison at 6.5 minutes post dose level 1.
194143|NCT01394926|O1|Outcome|Dose Level 1: Injection of 0.15mL Optison at Time 0.|Dose Level 1: Injection of 0.15mL Optison at time 0.
194144|NCT01394926|O3|Outcome|Dose Level 3: 1.5mL Optison 8 Minutes|Dose Level 3: Injection of 1.5mL of Optison 8 minutes post level 2.
194145|NCT01394926|O2|Outcome|Dose Level 2: 0.5mL of Optsion at Time 6.5 Minutes|Dose Level 2: Inj. of 0.5mL Optsion at time 6.5 minutes post dose level 1.
194146|NCT01394926|O1|Outcome|Dose Level 1: Injection of 0.15mL Optison at Time 0.|Dose Level 1 given as an Injection of 0.15mL of Optison at time 0.
194147|NCT01394926|E1|Reported Event|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
194148|NCT01394718|B3|Baseline|Total|Total of all reporting groups
194149|NCT01394718|B2|Baseline|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
194150|NCT01394718|B1|Baseline|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
194151|NCT01394718|P2|Participant Flow|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
194152|NCT01394718|P1|Participant Flow|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
194153|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
194154|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
194155|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
194156|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
194157|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
194301|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194533|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194158|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
194159|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
194160|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
194161|NCT01394718|E2|Reported Event|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
194162|NCT01394718|E1|Reported Event|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
194163|NCT01394692|B3|Baseline|Total|Total of all reporting groups
194164|NCT01394692|B2|Baseline|Conventional Group|standard microsurgical tumor resection
194165|NCT01394692|B1|Baseline|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
194166|NCT01394692|P2|Participant Flow|Conventional Group|standard microsurgical tumor resection
194167|NCT01394692|P1|Participant Flow|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
194168|NCT01394692|O2|Outcome|Conventional Group|standard microsurgical tumor resection
194169|NCT01394692|O1|Outcome|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
194170|NCT01394692|E2|Reported Event|Conventional Group|standard microsurgical tumor resection
194171|NCT01394692|E1|Reported Event|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
194172|NCT01394614|B3|Baseline|Total|Total of all reporting groups
194173|NCT01394614|B2|Baseline|Unexposed Narcoleptic Subjects|Unexposed (non-vaccinated or vaccinated after onset of symptoms) narcoleptic subjects to adjuvanted A/H1N1 vaccine
194174|NCT01394614|B1|Baseline|Exposed Narcoleptic Subjects|Exposed (vaccinated and onset of narcolepsy is after vaccine administration) narcoleptic subjects to adjuvanted A/H1N1 vaccine
194175|NCT01394614|P2|Participant Flow|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (not vaccinated or vaccinated after the onset of symptoms)
194176|NCT01394614|P1|Participant Flow|Narcoleptic Subjects Exposed to Vaccine|Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is after vaccine administration)
194177|NCT01394614|O2|Outcome|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
194178|NCT01394614|O1|Outcome|Exposed Narcoleptic Subjects|"Exposed (vaccinated and onset of narcolepsy is post-vaccination) narcoleptic subjects
Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine Arepanrix."
194179|NCT01394614|E2|Reported Event|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
194180|NCT01394614|E1|Reported Event|Exposed Narcoleptic Subjects|"Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is post-vaccination)
Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine (Arepanrix)"
194181|NCT01394510|B1|Baseline|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.
N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
194182|NCT01394510|P1|Participant Flow|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.
N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
194183|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.
N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
194184|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.
N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
194185|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.
N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
194302|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194534|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194186|NCT01394510|E1|Reported Event|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.
N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
194187|NCT01394276|B1|Baseline|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194188|NCT01394276|P1|Participant Flow|Tocilizumab|Participants with moderate to severe Rheumatoid arthritis (RA) who had received RoActemra [Tocilizumab (TCZ)] treatment for 6 months prior to initiation of study and are inadequate responders to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and anti-Tumor Necrosis Factors (anti-TNFs) agents were observed. Participants received treatment with TCZ with dose of 8 milligrams per kilogram (mg/kg) body weight, intravenously once every 4 weeks for 12 months according to European Union (EU) approved dosage, and Summary of Product Characteristics (SmPC).
194189|NCT01394276|O2|Outcome|DMARD + Anti-TNF- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194190|NCT01394276|O1|Outcome|DMARD- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194191|NCT01394276|O2|Outcome|DMARD + Anti-TNF- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194192|NCT01394276|O1|Outcome|DMARD- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194193|NCT01394276|O2|Outcome|DMARD + Anti-TNF-IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194194|NCT01394276|O1|Outcome|DMARD-IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194195|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194196|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents. Participants receiving treatment with TCZ with dose of 8 milligrams mg/kg body weight, intravenously once every 4 weeks for 12 months were observed. Dosage of TCZ was prescribed according to EU approved dosage, and SmPC.
194197|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194198|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194199|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194200|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194201|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194202|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194203|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194303|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194204|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194205|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194206|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194207|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194208|NCT01394276|E1|Reported Event|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
194209|NCT01394250|B3|Baseline|Total|Total of all reporting groups
194210|NCT01394250|B2|Baseline|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
194211|NCT01394250|B1|Baseline|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
194212|NCT01394250|P2|Participant Flow|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
194213|NCT01394250|P1|Participant Flow|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
194214|NCT01394250|O2|Outcome|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
194215|NCT01394250|O1|Outcome|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
194216|NCT01394250|O2|Outcome|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
194217|NCT01394250|O1|Outcome|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
194218|NCT01394250|E2|Reported Event|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
194219|NCT01394250|E1|Reported Event|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
194220|NCT01394185|B1|Baseline|All Participants|Participants received dronabinol (PL, 120mg, 240mg/day) in a randomized within-subject crossover design
194221|NCT01394185|P6|Participant Flow|Placebo, 240mg, 120mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
194222|NCT01394185|P5|Participant Flow|240mg, Placebo, 120mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
194223|NCT01394185|P4|Participant Flow|120mg, Placebo, 240mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
194224|NCT01394185|P3|Participant Flow|240mg, 120mg, Placebo|Participants received dronabinol for 12 days in the above order in a within-subject crossover
194225|NCT01394185|P2|Participant Flow|120mg, 240mg, Placebo|Participants received dronabinol for 12 days in the above order in a within-subject crossover
194226|NCT01394185|P1|Participant Flow|Placebo, 120mg, 240mg|Participants received dronabinol for 12 days in the above order in a within-subject crossover
194227|NCT01394185|O3|Outcome|240mg Dronabinol|240mg/day (80mg tid) dronabinol maintenance period
194228|NCT01394185|O2|Outcome|120mg Dronabinol|120mg/day (40mg tid) dronabinol maintenance period
194229|NCT01394185|O1|Outcome|Placebo|Placebo maintenance period
194230|NCT01394185|O3|Outcome|240mg Dronabinol|240mg/day (80mg tid) dronabinol maintenance period
194231|NCT01394185|O2|Outcome|120mg Dronabinol|120mg/day (40mg tid) dronabinol maintenance period
194232|NCT01394185|O1|Outcome|Placebo|Placebo maintenance period
194233|NCT01394185|E3|Reported Event|240mg Dronabinol|240mg (80mg tid) dronabinol maintenance
194234|NCT01394185|E2|Reported Event|120mg Dronabinol|120mg (40mg tid) dronabinol maintenance
194235|NCT01394185|E1|Reported Event|Placebo|Placebo dronabinol maintenance
194236|NCT01394159|B3|Baseline|Total|Total of all reporting groups
194237|NCT01394159|B2|Baseline|FNA Needle|FNA: Acquire tissue with FNA needle
194238|NCT01394159|B1|Baseline|ProCore Biopsy|"Acquire biopsy with procore needle
Procore Biopsy: Acquire tissue with procore biopsy needle"
194239|NCT01394159|P2|Participant Flow|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
194240|NCT01394159|P1|Participant Flow|22G ProCore Biopsy|"Acquire biopsy with procore needle
Procore Biopsy: Acquire tissue with procore biopsy needle"
194241|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
194242|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle
Procore Biopsy: Acquire tissue with procore biopsy needle"
194243|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
194244|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle
Procore Biopsy: Acquire tissue with procore biopsy needle"
194245|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
194246|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle
Procore Biopsy: Acquire tissue with procore biopsy needle"
194247|NCT01394159|E2|Reported Event|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
194248|NCT01394159|E1|Reported Event|22G ProCore Biopsy|"Acquire biopsy with procore needle
Procore Biopsy: Acquire tissue with procore biopsy needle"
194249|NCT01393964|B4|Baseline|Total|Total of all reporting groups
194348|NCT01393899|E1|Reported Event|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194250|NCT01393964|B3|Baseline|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194251|NCT01393964|B2|Baseline|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194252|NCT01393964|B1|Baseline|Elotuzumab + LD in Normal Renal Function (NRF) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194253|NCT01393964|P3|Participant Flow|Elotuzumab + LD in End Stage Renal Disease(ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD = requires hemodialysis.
194254|NCT01393964|P2|Participant Flow|Elotuzumab + LD in Severe Renal Impairment(SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI = estimated CrCl < 30 ml/min but no dialysis.
194255|NCT01393964|P1|Participant Flow|Elotuzumab + LD in Normal Renal Function(NRF) Participants|Combination of lenalidomide and dexamethasone (LD). Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle (per product label). Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF = CrCl ≥ 90 milliliters per minute (mL/min).
194256|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194257|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194266|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194258|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194259|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194260|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194261|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194262|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194263|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194264|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194265|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194295|NCT01393899|B1|Baseline|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194296|NCT01393899|P3|Participant Flow|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194267|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194268|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194269|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194270|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194271|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194272|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194273|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194274|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194297|NCT01393899|P2|Participant Flow|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194298|NCT01393899|P1|Participant Flow|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194275|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194276|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194277|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194278|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194279|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194280|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194281|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194282|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194299|NCT01393899|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194300|NCT01393899|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194283|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194284|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194285|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194286|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194287|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194288|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194289|NCT01393964|E3|Reported Event|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
194290|NCT01393964|E2|Reported Event|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
194291|NCT01393964|E1|Reported Event|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
194292|NCT01393899|B4|Baseline|Total|Total of all reporting groups
194293|NCT01393899|B3|Baseline|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194294|NCT01393899|B2|Baseline|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194304|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194305|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194306|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194307|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194308|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194309|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194310|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194311|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194312|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194313|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194314|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194315|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194316|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194317|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194318|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194319|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194320|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194321|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194322|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194323|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194324|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194325|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194326|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194327|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194328|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194329|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194330|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194331|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194332|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194333|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194334|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194335|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194336|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194337|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194338|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194339|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194340|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194341|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194342|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194343|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194344|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194345|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
194346|NCT01393899|E3|Reported Event|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
194347|NCT01393899|E2|Reported Event|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
194350|NCT01393743|B2|Baseline|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
194351|NCT01393743|B1|Baseline|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
194352|NCT01393743|P3|Participant Flow|Perampanel (Extension Phase)|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who were assigned to the perampanel arm in the Core Study continued to receive blinded perampanel once daily at the dose received during the Maintenance Period of the Core Study. During the Conversion Period, dose adjustments could be made at the investigator’s discretion. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
194353|NCT01393743|P2|Participant Flow|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
194354|NCT01393743|P1|Participant Flow|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
194355|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
194356|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
194357|NCT01393743|O2|Outcome|All Seizures|The median percent change from the Pre-perampanel baseline in the seizure frequency per 28 days of all seizures by 13-week intervals through greater than or equal to Week 144.
194358|NCT01393743|O1|Outcome|PGTC Seizures|The median percent change from the Pre-perampanel baseline in PGTC seizure frequency per 28 days by 13-week intervals through greater than or equal to Week 144.
194359|NCT01393743|O1|Outcome|Perampanel (Extension Phase)|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who were assigned to the perampanel arm in the Core Study continued to receive blinded perampanel once daily at the dose received during the Maintenance Period of the Core Study. During the Conversion Period, dose adjustments could be made at the investigator’s discretion. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
194360|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
194361|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
194362|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
194363|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
194364|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
194365|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
194366|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
194367|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
194368|NCT01393743|O1|Outcome|Perampanel Extension Phase|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who received placebo in the Core Study were started on blinded oral perampanel (2 mg/day) and were up-titrated weekly in 2-mg increments to the optimal dose per investigator's discretion, up to 12 mg/day perampanel maximum. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
194419|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
194420|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
194369|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
194370|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
194371|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
194372|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
194373|NCT01393743|E3|Reported Event|Perampanel (Extension Phase)|The Extension Phase consisted of two parts: Part A (6-week blinded Conversion Period plus a 32-week Maintenance Period) and Part B (maximum of 104-week Maintenance Period), which was followed by an additional 4-week Follow-up Period. Part A: Participants who were assigned to the perampanel arm in the Core Study continued to receive blinded perampanel once daily at the dose received during the Maintenance Period of the Core Study. During the Conversion Period, dose adjustments could be made at the investigator’s discretion. Part B: Participants were unblinded to study treatment and remained on the optimal perampanel dose established during the blinded Conversion Period (Part A). Dose adjustment in 2-mg increments (upwards or downwards) was allowed at the investigator's discretion. Participants who could not tolerate a dose of 2 mg/day perampanel during the Extension Period were discontinued from the study. The maximum dose of perampanel allowed during the Extension Phase was 12 mg/day.
194374|NCT01393743|E2|Reported Event|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
194375|NCT01393743|E1|Reported Event|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day, before bedtime and with food.
194376|NCT01393730|B1|Baseline|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194377|NCT01393730|P1|Participant Flow|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194378|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194379|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194380|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194381|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194382|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194383|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194384|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194385|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194386|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194387|NCT01393730|E1|Reported Event|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression
Abiraterone acetate: 1000 mg orally, once per day
Dutasteride: 3.5 mg orally once per day
Prednisone: 5 mg orally once per day"
194388|NCT01393704|B3|Baseline|Total|Total of all reporting groups
194389|NCT01393704|B2|Baseline|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194390|NCT01393704|B1|Baseline|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194391|NCT01393704|P2|Participant Flow|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194392|NCT01393704|P1|Participant Flow|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194393|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194394|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194395|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194396|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194397|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194398|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194399|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194400|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194401|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194402|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194403|NCT01393704|E2|Reported Event|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194404|NCT01393704|E1|Reported Event|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
194405|NCT01393626|B5|Baseline|Total|Total of all reporting groups
194406|NCT01393626|B4|Baseline|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
194407|NCT01393626|B3|Baseline|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194408|NCT01393626|B2|Baseline|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194409|NCT01393626|B1|Baseline|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194410|NCT01393626|P4|Participant Flow|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
194411|NCT01393626|P3|Participant Flow|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194412|NCT01393626|P2|Participant Flow|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194413|NCT01393626|P1|Participant Flow|Placebo|Placebo tablets to match tofacitinib 5 milligrams (mg) for oral administration twice daily (BID) for 8 weeks.
194414|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
194415|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
194416|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
194417|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
194421|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
194422|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
194423|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
194424|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
194425|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
194426|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
194427|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
194428|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
194429|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
194430|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
194431|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
194432|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
194433|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
194434|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
194435|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
194436|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194437|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194438|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194439|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
194440|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194441|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194442|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194443|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
194444|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194445|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194446|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194447|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
194448|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
194449|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
194450|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
194451|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
194452|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
194453|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
194454|NCT01393626|O3|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
194455|NCT01393626|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194456|NCT01393626|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194457|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
194458|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194459|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194460|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194461|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
194462|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194463|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194464|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194465|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
194466|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194467|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194468|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194469|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194470|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194471|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194472|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194473|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194474|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194475|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194476|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194477|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194478|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194479|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194480|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194481|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194482|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194483|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194484|NCT01393626|E4|Reported Event|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
194485|NCT01393626|E3|Reported Event|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
194486|NCT01393626|E2|Reported Event|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
194487|NCT01393626|E1|Reported Event|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
194488|NCT01393613|B5|Baseline|Total|Total of all reporting groups
194489|NCT01393613|B4|Baseline|Placebo|Placebo tablet once daily for 6 weeks.
194490|NCT01393613|B3|Baseline|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194491|NCT01393613|B2|Baseline|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194492|NCT01393613|B1|Baseline|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194493|NCT01393613|P4|Participant Flow|Placebo|Placebo tablet once daily for 6 weeks.
194494|NCT01393613|P3|Participant Flow|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194495|NCT01393613|P2|Participant Flow|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194496|NCT01393613|P1|Participant Flow|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194497|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194498|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194499|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194500|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194501|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
194502|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
194503|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194504|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194505|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194506|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194507|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194508|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194509|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194510|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194511|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194512|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194513|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194514|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194515|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194516|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194517|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194518|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194519|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194520|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194521|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194522|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194523|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194524|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194525|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194526|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194527|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194528|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194529|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194535|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194536|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194537|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194538|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194539|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194540|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194541|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194542|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194543|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194544|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194545|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194546|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194547|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194548|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194549|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
194550|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194551|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194552|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194553|NCT01393613|E4|Reported Event|Placebo|Placebo tablet once daily for 6 weeks.
194554|NCT01393613|E3|Reported Event|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
194555|NCT01393613|E2|Reported Event|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
194556|NCT01393613|E1|Reported Event|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
194557|NCT01393600|B1|Baseline|All Subjects|All randomized subjects who received at least one dose of study drug.
194558|NCT01393600|P4|Participant Flow|Valbenazine 50 mg, Then Placebo|Participants first received valbenazine 50 mg solution once daily from Day 1 to 14, then they received Placebo (matching valbenazine solution) once daily from Day 15 to 28.
194559|NCT01393600|P3|Participant Flow|Placebo, Then Valbenazine 50 mg|Participants first received Placebo (matching valbenazine solution) once daily from Day 1 to 14, then they received valbenazine 50 mg solution once daily from Day 15 to 28.
194560|NCT01393600|P2|Participant Flow|Valbenazine 12.5 mg, Then Placebo|Participants first received valbenazine 12.5 mg solution once daily from Day 1 to 14, then they received Placebo (matching valbenazine solution) once daily from Day 15 to 28.
194561|NCT01393600|P1|Participant Flow|Placebo, Then Valbenazine 12.5 mg|Participants first received Placebo (matching valbenazine solution) once daily from Day 1 to 14, then they received valbenazine 12.5 mg solution once daily from Day 15 to 28.
194562|NCT01393600|O3|Outcome|Valbenazine 50 mg|Valbenazine 50 mg solution
194563|NCT01393600|O2|Outcome|Valbenazine 12.5 mg|Valbenazine 12.5 mg solution
194564|NCT01393600|O1|Outcome|Placebo|Placebo (matching valbenazine solution)
194565|NCT01393600|O4|Outcome|Valbenazine 50mg|Participants who received valbenazine 50mg solution once daily from Day 1 to 14 and participants who received valbenazine 50mg solution from Day 15 to 28.
194566|NCT01393600|O3|Outcome|Valbenazine 50mg Placebo|Participants who received Placebo (matching valbenazine 50mg solution) once daily from Day 1 to 14 and participants who received Placebo (matching valbenazine 50mg solution) from Day 15 to 28.
194567|NCT01393600|O2|Outcome|Valbenazine 12.5mg|Participants who received valbenazine 12.5mg solution once daily from Day 1 to 14 and participants who received valbenazine 12.5mg solution from Day 15 to 28.
194568|NCT01393600|O1|Outcome|Valbenazine 12.5mg Placebo|Participants who received Placebo (matching valbenazine 12.5mg solution) once daily from Day 1 to 14 and participants who received Placebo (matching valbenazine 12.5mg solution) from Day 15 to 28.
194569|NCT01393600|O3|Outcome|Valbenazine 50 mg|Valbenazine 50 mg solution
194570|NCT01393600|O2|Outcome|Valbenazine 12.5 mg|Valbenazine 12.5 mg solution
194571|NCT01393600|O1|Outcome|Placebo|Placebo (matching valbenazine solution)
194572|NCT01393600|E3|Reported Event|NBI-98854 50 mg|NBI-98854 50 mg solution for 28 days followed by 7 days of posttreatment.
194573|NCT01393600|E2|Reported Event|NBI-98854 12.5 mg|NBI-98854 12.5 mg solution for 28 days followed by 7 days of posttreatment.
194574|NCT01393600|E1|Reported Event|Placebo|Placebo (matching NBI-98854 solution) for 28 days followed by 7 days of posttreatment.
194575|NCT01393444|B1|Baseline|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.
Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
194576|NCT01393444|P1|Participant Flow|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.
Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
194577|NCT01393444|O1|Outcome|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.
Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
194578|NCT01393444|O1|Outcome|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.
Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
194579|NCT01393444|E1|Reported Event|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.
Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
194581|NCT01393132|B2|Baseline|Placebo|"Comparison
Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
194582|NCT01393132|B1|Baseline|Thymosin|"Comparison
Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
194583|NCT01393132|P2|Participant Flow|Placebo|"Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial
Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days."
194584|NCT01393132|P1|Participant Flow|Thymosin|"Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial
Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days.
Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.
Period Title * Participant Flow: Overall Study
Placebo Thymosin Beta 4 Started 3 6 Completed 3 6"
194585|NCT01393132|O2|Outcome|Placebo|"Comparison
Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
194586|NCT01393132|O1|Outcome|Thymosin|"Comparison
Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
194587|NCT01393132|O2|Outcome|Placebo|"Comparison
Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
194588|NCT01393132|O1|Outcome|Thymosin|"Comparison
Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
194589|NCT01393132|O2|Outcome|Placebo|"Comparison
Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
194590|NCT01393132|O1|Outcome|Thymosin|"Comparison
Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
194591|NCT01393132|O2|Outcome|Placebo|Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
194592|NCT01393132|O1|Outcome|Thymosin|Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.
194593|NCT01393132|E2|Reported Event|Placebo|: A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
194594|NCT01393132|E1|Reported Event|Thymosin Beta 4|Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.
194595|NCT01393106|B1|Baseline|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194596|NCT01393106|P1|Participant Flow|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194597|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194598|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194599|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194600|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194601|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194602|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194603|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194604|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194605|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194606|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194607|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194608|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194609|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194610|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194611|NCT01393106|E1|Reported Event|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
194612|NCT01392742|B1|Baseline|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194613|NCT01392742|P1|Participant Flow|Hepatitis C Virus (HCV) Infected Participants|Participants who were infected by HCV and receiving pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 micrograms per week (µg/week) subcutaneously, plus ribavirin tablets 1000 milligrams (mg) (those weighing less than [<] 75 kilograms [kg]) or 1200 mg (those weighing greater than [>] 75 kg) orally; were observed for approximately up to 24 weeks after end of treatment (EOT). Dose change was as per investigators’ discretion.
194614|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194615|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194616|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194617|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194618|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194619|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194620|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194621|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194622|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194623|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194624|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194625|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
194626|NCT01392742|E1|Reported Event|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately 24 weeks. Dose change was as per investigators’ discretion.
194627|NCT01392703|B1|Baseline|All Treated|
194628|NCT01392703|P3|Participant Flow|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
194629|NCT01392703|P2|Participant Flow|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194630|NCT01392703|P1|Participant Flow|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194631|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
194632|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194712|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
194633|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194634|NCT01392703|O1|Outcome|All Treated|
194635|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
194636|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194637|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194638|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
194639|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194640|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194641|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
194642|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194643|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194644|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
194645|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period..
194646|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194647|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
194648|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194649|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194650|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
194651|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194652|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194713|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
194714|NCT01392495|E2|Reported Event|QTI571 400mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
194653|NCT01392703|E3|Reported Event|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
194654|NCT01392703|E2|Reported Event|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194655|NCT01392703|E1|Reported Event|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
194656|NCT01392677|B3|Baseline|Total|Total of all reporting groups
194657|NCT01392677|B2|Baseline|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
194658|NCT01392677|B1|Baseline|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
194659|NCT01392677|P2|Participant Flow|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
194660|NCT01392677|P1|Participant Flow|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
194661|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
194662|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
194663|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
194664|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
194665|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
194666|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
194667|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
194668|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
194669|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
194670|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
194671|NCT01392677|E2|Reported Event|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
194672|NCT01392677|E1|Reported Event|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
194673|NCT01392573|B3|Baseline|Total|Total of all reporting groups
194674|NCT01392573|B2|Baseline|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
194675|NCT01392573|B1|Baseline|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
194676|NCT01392573|P2|Participant Flow|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
194677|NCT01392573|P1|Participant Flow|IDegLira|Insulin degludec/liraglutide (IDegLira) was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast self-monitored plasma glucose (SMPG) values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
194678|NCT01392573|O2|Outcome|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
194679|NCT01392573|O1|Outcome|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
194715|NCT01392495|E1|Reported Event|QTI571 200mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
194680|NCT01392573|O2|Outcome|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
194681|NCT01392573|O1|Outcome|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
194682|NCT01392573|E2|Reported Event|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
194683|NCT01392573|E1|Reported Event|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
194684|NCT01392560|B1|Baseline|Empagliflozin (BI 10773) 25 mg|"Oral once daily
Empagliflozin 25 mg: Oral once daily"
194685|NCT01392560|P1|Participant Flow|Empagliflozin (BI 10773) 25 mg|"Oral once daily
Empagliflozin 25 mg: Oral once daily"
194686|NCT01392560|O3|Outcome|Non-hyperfilterers (Empagliflozin 25 mg)|"Non-hyperfilterers
Empagliflozin 25 mg: Oral once daily
non-hyperfilterers = GFRs of ≥60 mL/min/1.73m2 to <135 mL/min/1.73m2"
194687|NCT01392560|O2|Outcome|Hyperfilterers (Empagliflozin 25 mg)|"Hyperfilterers
Empagliflozin 25 mg: Oral once daily
hyperfilterers = GFRs of ≥135 mL/min/1.73m2"
194688|NCT01392560|O1|Outcome|All Patients (Empagliflozin 25 mg)|"All patients (hyperfilterers and non-hyperfilterers)
Empagliflozin 25 mg: Oral once daily"
194689|NCT01392560|E1|Reported Event|Empagliflozin 25 mg|"Oral once daily
Empagliflozin 25 mg: Oral once daily"
194690|NCT01392547|B1|Baseline|Vatrepcacog Alfa and rFVIIa|Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner.
194691|NCT01392547|P1|Participant Flow|Vatreptacog Alfa and rFVIIa (All Subjects)|Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner. Subjects participating in the trial had bleeding episodes randomised to treatment with either vatraptacog alfa or rFVIIa in an independent manner for each bleeding episodes. Of the 72 subjects, 3 subjects did not have any bleeds.
194692|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
194693|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
194694|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
194695|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
194696|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
194697|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
194698|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
194699|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
194700|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
194701|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
194702|NCT01392547|E2|Reported Event|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
194703|NCT01392547|E1|Reported Event|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
194704|NCT01392495|B1|Baseline|QTI571|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
194705|NCT01392495|P1|Participant Flow|QTI571|Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
194706|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
194707|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
194708|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
194709|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
194710|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
194711|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
194716|NCT01392378|B6|Baseline|Total|Total of all reporting groups
194717|NCT01392378|B5|Baseline|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194718|NCT01392378|B4|Baseline|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194719|NCT01392378|B3|Baseline|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194720|NCT01392378|B2|Baseline|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194721|NCT01392378|B1|Baseline|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194722|NCT01392378|P5|Participant Flow|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194723|NCT01392378|P4|Participant Flow|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194724|NCT01392378|P3|Participant Flow|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194725|NCT01392378|P2|Participant Flow|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194726|NCT01392378|P1|Participant Flow|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194727|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194728|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194729|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194782|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194730|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194731|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194732|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194733|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194734|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194735|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194736|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194737|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194738|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194739|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194740|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194741|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194742|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194822|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194743|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194744|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194745|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194746|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194747|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194748|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194749|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194750|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194751|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194752|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194753|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194754|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194755|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194871|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
194872|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
194873|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
194874|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
194756|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194757|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194758|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194759|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194760|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194761|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194762|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194763|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194764|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194765|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194766|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194767|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194768|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194875|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
194876|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
194877|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
194878|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
194879|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
194769|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194770|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194771|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194772|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194773|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194774|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194775|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194776|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194777|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194778|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194779|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194780|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194781|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194880|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
194881|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
194882|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
194783|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194784|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194785|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194786|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194787|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194788|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194789|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194790|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194791|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194792|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194793|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194794|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194795|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194883|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
194884|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
194885|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
194886|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
194796|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194797|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194798|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194799|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194800|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194801|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194802|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194803|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194804|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194805|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194806|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194807|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194808|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194887|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
194888|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
194889|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
194890|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
194891|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
194809|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194810|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194811|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194812|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194813|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194814|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194815|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194816|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194817|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194818|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194819|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194820|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194821|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194892|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
194893|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
194894|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
194823|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194824|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194825|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194826|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194827|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194828|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194829|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194830|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194831|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194832|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194833|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194834|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194835|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194895|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
194896|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
194897|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
194898|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
194836|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194837|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194838|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194839|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194840|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194841|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194842|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
194843|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
194844|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
194845|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
194846|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
194847|NCT01392378|E15|Reported Event|13vPnC + INFANRIX Hexa - Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
194848|NCT01392378|E14|Reported Event|13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with ibuprofen suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
194899|NCT01392326|E3|Reported Event|Placebo|Placebo. After week 24, only reponders continued to receive placebo to the end of the trial.
194849|NCT01392378|E13|Reported Event|13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
194850|NCT01392378|E12|Reported Event|13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
194851|NCT01392378|E11|Reported Event|13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
194852|NCT01392378|E10|Reported Event|13vPnC + INFANRIX Hexa - After Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series, assessed after the infant series blood draw up to toddler dose.
194853|NCT01392378|E9|Reported Event|13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
194854|NCT01392378|E8|Reported Event|13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
194855|NCT01392378|E7|Reported Event|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
194856|NCT01392378|E6|Reported Event|13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
194857|NCT01392378|E5|Reported Event|13vPnC + INFANRIX Hexa - Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series (Inf Ser).
194858|NCT01392378|E4|Reported Event|13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
194859|NCT01392378|E3|Reported Event|13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
194860|NCT01392378|E2|Reported Event|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
194861|NCT01392378|E1|Reported Event|13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
194862|NCT01392326|B4|Baseline|Total|Total of all reporting groups
194863|NCT01392326|B3|Baseline|Group 3|Placebo match (for 75 and 150 mg)
194864|NCT01392326|B2|Baseline|Group 2|Secukinumab (150 mg)
194865|NCT01392326|B1|Baseline|Group 1|Secukinumab (75mg)
194866|NCT01392326|P3|Participant Flow|Placebo Match for AIN457 ( 75 and 150 mg)|Placebo match (for 75 and 150 mg)
194867|NCT01392326|P2|Participant Flow|AIN457 (150 mg)|Secukinumab (150 mg)
194868|NCT01392326|P1|Participant Flow|AIN457 (75 mg)|Secukinumab (75mg)
194869|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
194870|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
194900|NCT01392326|E2|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
194901|NCT01392326|E1|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
194902|NCT01392300|B3|Baseline|Total|Total of all reporting groups
194903|NCT01392300|B2|Baseline|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194904|NCT01392300|B1|Baseline|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194905|NCT01392300|P3|Participant Flow|OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections)|IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
194906|NCT01392300|P2|Participant Flow|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194907|NCT01392300|P1|Participant Flow|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194908|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194909|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194910|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194911|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194912|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194913|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194914|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194915|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194916|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194917|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194918|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194919|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194920|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194921|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194922|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194923|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194924|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194925|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194926|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194927|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194928|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194929|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194930|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194931|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194932|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194933|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194934|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195050|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)
lyrica: 150mg of pregabalin/placebo"
194935|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194936|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194937|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194938|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194939|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194940|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194941|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194942|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194943|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194944|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194945|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194946|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194947|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194948|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194949|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194950|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194951|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194952|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194953|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194954|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194955|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194956|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194957|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194958|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194959|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194960|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194961|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194962|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194963|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194964|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194965|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194966|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194967|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194968|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194969|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194970|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194971|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194972|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194973|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194974|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194975|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194976|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194977|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194978|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194979|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194980|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194981|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194982|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194983|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194984|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194985|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194986|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194987|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194988|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194989|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194990|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194991|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194992|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194993|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194994|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194995|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194996|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194997|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194998|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
194999|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195000|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195001|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195002|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195003|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195004|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195005|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195006|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195007|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195008|NCT01392300|E3|Reported Event|OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections)|IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
195009|NCT01392300|E2|Reported Event|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195010|NCT01392300|E1|Reported Event|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
195011|NCT01392170|B1|Baseline|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
195012|NCT01392170|P1|Participant Flow|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
195013|NCT01392170|O1|Outcome|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
195014|NCT01392170|E1|Reported Event|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
195015|NCT01392053|B3|Baseline|Total|Total of all reporting groups
195016|NCT01392053|B2|Baseline|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
195017|NCT01392053|B1|Baseline|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
195018|NCT01392053|P2|Participant Flow|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
195019|NCT01392053|P1|Participant Flow|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
195020|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
195021|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
195022|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
195023|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
195024|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
195025|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
195026|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
195027|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
195028|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
195029|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
195030|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
195031|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
195032|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
195033|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
195034|NCT01392053|E2|Reported Event|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
195035|NCT01392053|E1|Reported Event|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
195036|NCT01391858|B3|Baseline|Total|Total of all reporting groups
195037|NCT01391858|B2|Baseline|Placebo|"placebo
lyrica: 150mg of pregabalin/placebo"
195038|NCT01391858|B1|Baseline|Pregabalin|"pregabalin (lyrica)
lyrica: 150mg of pregabalin/placebo"
195039|NCT01391858|P2|Participant Flow|Placebo|Placebo 1-2 hrs. before the surgery and then twice daily for 14 days
195040|NCT01391858|P1|Participant Flow|Pregabalin|Pregabalin 300 mg 1-2 hrs. before the surgery and then 150 mg twice a day for 14 days
195041|NCT01391858|O2|Outcome|Placebo|"placebo
lyrica: 150mg of pregabalin/placebo"
195042|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)
lyrica: 150mg of pregabalin/placebo"
195043|NCT01391858|O2|Outcome|Placebo|"placebo
lyrica: 150mg of pregabalin/placebo"
195044|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)
lyrica: 150mg of pregabalin/placebo"
195045|NCT01391858|O2|Outcome|Placebo|"placebo
lyrica: 150mg of pregabalin/placebo"
195046|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)
lyrica: 150mg of pregabalin/placebo"
195047|NCT01391858|O2|Outcome|Placebo|"placebo
lyrica: 150mg of pregabalin/placebo"
195048|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)
lyrica: 150mg of pregabalin/placebo"
195049|NCT01391858|O2|Outcome|Placebo|"placebo
lyrica: 150mg of pregabalin/placebo"
195051|NCT01391858|O2|Outcome|Placebo|"placebo
lyrica: 150mg of pregabalin/placebo"
195052|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)
lyrica: 150mg of pregabalin/placebo"
195053|NCT01391858|O2|Outcome|Placebo|"placebo
lyrica: 150mg of pregabalin/placebo"
195054|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)
lyrica: 150mg of pregabalin/placebo"
195055|NCT01391858|O2|Outcome|Placebo|"placebo
lyrica: 150mg of pregabalin/placebo"
195056|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)
lyrica: 150mg of pregabalin/placebo"
195057|NCT01391858|E2|Reported Event|Placebo|"placebo
lyrica: 150mg of pregabalin/placebo"
195058|NCT01391858|E1|Reported Event|Pregabalin|"pregabalin (lyrica)
lyrica: 150mg of pregabalin/placebo"
195059|NCT01391819|B1|Baseline|Dengue Group|Subjects, male and female, aged 5-13 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195060|NCT01391819|P1|Participant Flow|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195061|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195062|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195063|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195064|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195065|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195066|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195067|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195068|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195069|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195070|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195071|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195072|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195073|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195074|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195075|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195076|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195077|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195078|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195079|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195080|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195081|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195082|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195083|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195084|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195085|NCT01391819|E1|Reported Event|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
195086|NCT01391663|B5|Baseline|Total|Total of all reporting groups
195087|NCT01391663|B4|Baseline|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
195088|NCT01391663|B3|Baseline|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
195089|NCT01391663|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
195090|NCT01391663|B1|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
195091|NCT01391663|P4|Participant Flow|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
195218|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
195092|NCT01391663|P3|Participant Flow|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
195093|NCT01391663|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
195094|NCT01391663|P1|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
195095|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
195096|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
195097|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
195098|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
195099|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
195100|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
195101|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
195102|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
195103|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
195104|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
195105|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
195106|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
195107|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
195108|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
195109|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
195110|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
195111|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
195112|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
195113|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
195114|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
195115|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
195116|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
195117|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
195118|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
195119|NCT01391663|E4|Reported Event|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
195120|NCT01391663|E3|Reported Event|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
195121|NCT01391663|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
195122|NCT01391663|E1|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
195123|NCT01391611|B1|Baseline|Pazopanib Arm|Pazopanib: 800 mg; PO
195124|NCT01391611|P1|Participant Flow|Pazopanib Arm|Pazopanib: 800 mg; PO
195125|NCT01391611|O1|Outcome|Pazopanib Arm|Pazopanib: 800 mg; PO
195126|NCT01391611|O1|Outcome|Pazopanib Arm|Pazopanib: 800 mg; PO
195127|NCT01391611|E1|Reported Event|Pazopanib Arm|Pazopanib: 800 mg; PO
195128|NCT01391559|B1|Baseline|Entire Study Population|Includes groups randomized to receive Arformoterol first and Salmeterol first
195129|NCT01391559|P2|Participant Flow|Salmeterol First, Then Arformoterol|Salmeterol (50 mcg) Diskus in the first intervention, Arformoterol (15 mcg/2 mL) solution via nebulizer in the second intervention
195130|NCT01391559|P1|Participant Flow|Arformoterol First, Then Salmeterol|Arformoterol (15 mcg/2 mL) solution via nebulizer in the first intervention, Salmeterol (50 mcg) Diskus in the second intervention
195131|NCT01391559|O2|Outcome|Salmeterol|Salmeterol dry powder (50 mcg) via Diskus
195132|NCT01391559|O1|Outcome|Arformoterol|Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer
195133|NCT01391559|E2|Reported Event|Salmeterol|Salmeterol dry powder (50 mcg) via Diskus
195134|NCT01391559|E1|Reported Event|Arformoterol|Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer
195135|NCT01391507|B5|Baseline|Total|Total of all reporting groups
195136|NCT01391507|B4|Baseline|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195137|NCT01391507|B3|Baseline|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195138|NCT01391507|B2|Baseline|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195139|NCT01391507|B1|Baseline|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195140|NCT01391507|P4|Participant Flow|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195141|NCT01391507|P3|Participant Flow|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195142|NCT01391507|P2|Participant Flow|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
196307|NCT01388816|E4|Reported Event|DRL-17822 300 mg|Once daily after breakfast
195143|NCT01391507|P1|Participant Flow|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195144|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195145|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195146|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195147|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195148|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195149|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195150|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195151|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195152|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195153|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195154|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195155|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195156|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195157|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195158|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195159|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195160|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195161|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195162|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195163|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195164|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195165|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195166|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195167|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195168|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195169|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195170|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195171|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195172|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195173|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195174|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195175|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195176|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
196308|NCT01388816|E3|Reported Event|DRL-17822 150 mg|Once daily after breakfast
195177|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195178|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195179|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195180|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195181|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195182|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195183|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195184|NCT01391507|E4|Reported Event|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195185|NCT01391507|E3|Reported Event|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195186|NCT01391507|E2|Reported Event|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195187|NCT01391507|E1|Reported Event|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
195188|NCT01391468|B3|Baseline|Total|Total of all reporting groups
195189|NCT01391468|B2|Baseline|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
195190|NCT01391468|B1|Baseline|Placebo|Cornstarch: placebo will be given in 6 months
195191|NCT01391468|P2|Participant Flow|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
195192|NCT01391468|P1|Participant Flow|Placebo|Cornstarch: placebo will be given in 6 months
195193|NCT01391468|O2|Outcome|Placebo|Plabeco group received maltodextrin for 6 months
195194|NCT01391468|O1|Outcome|Probiotics|"probiotics
Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
195195|NCT01391468|O2|Outcome|Placebo|Placeo group received maltodextrin for 6 months
195196|NCT01391468|O1|Outcome|Probiotics|"probiotics
Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
195197|NCT01391468|O2|Outcome|Probiotics|"probiotics
Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
195198|NCT01391468|O1|Outcome|Placebo|"cornstarch
Cornstarch: placebo will be given in 6 months"
195199|NCT01391468|O2|Outcome|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
195200|NCT01391468|O1|Outcome|Placebo|Cornstarch: placebo will be given in 6 months
195201|NCT01391468|E2|Reported Event|Placebo|Cornstarch: placebo will be given in 6 months
195202|NCT01391468|E1|Reported Event|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
195203|NCT01391325|B1|Baseline|Allopurinol|"Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
195204|NCT01391325|P1|Participant Flow|Allopurinol|"Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
195205|NCT01391325|O1|Outcome|Allopurinol|"Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
195206|NCT01391325|O1|Outcome|Allopurinol|"Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
195207|NCT01391325|O1|Outcome|Allopurinol|"Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
195208|NCT01391325|O1|Outcome|Allopurinol|"Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
195209|NCT01391325|E1|Reported Event|Allopurinol|"Treatment.
Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
195210|NCT01391312|B3|Baseline|Total|Total of all reporting groups
195211|NCT01391312|B2|Baseline|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
195212|NCT01391312|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
195213|NCT01391312|P2|Participant Flow|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
195214|NCT01391312|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
195215|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
195216|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
195217|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
195219|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
195220|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
195221|NCT01391312|E2|Reported Event|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
195222|NCT01391312|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
195223|NCT01391299|B4|Baseline|Total|Total of all reporting groups
195224|NCT01391299|B3|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
195225|NCT01391299|B2|Baseline|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195226|NCT01391299|B1|Baseline|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195227|NCT01391299|P3|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
195228|NCT01391299|P2|Participant Flow|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195229|NCT01391299|P1|Participant Flow|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195230|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
195231|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195232|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195233|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
195234|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195235|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195236|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
195237|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195238|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195239|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
195240|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195241|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195242|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
195243|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195244|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195245|NCT01391299|E3|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
195246|NCT01391299|E2|Reported Event|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195247|NCT01391299|E1|Reported Event|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
195248|NCT01391286|B3|Baseline|Total|Total of all reporting groups
195249|NCT01391286|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195250|NCT01391286|B1|Baseline|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195251|NCT01391286|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195252|NCT01391286|P1|Participant Flow|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195253|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195254|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195255|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195256|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195257|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195258|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195259|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195260|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
196236|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
195261|NCT01391286|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195262|NCT01391286|E1|Reported Event|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195263|NCT01391273|B3|Baseline|Total|Total of all reporting groups
195264|NCT01391273|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195265|NCT01391273|B1|Baseline|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195266|NCT01391273|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195267|NCT01391273|P1|Participant Flow|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195268|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195269|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195270|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195271|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195272|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195273|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195274|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195275|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195276|NCT01391273|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
195277|NCT01391273|E1|Reported Event|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
195278|NCT01391013|B3|Baseline|Total|Total of all reporting groups
195279|NCT01391013|B2|Baseline|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195280|NCT01391013|B1|Baseline|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195281|NCT01391013|P2|Participant Flow|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195282|NCT01391013|P1|Participant Flow|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195283|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195284|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195285|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195286|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195287|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195288|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195289|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195290|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195291|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195292|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195293|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195294|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195295|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195296|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195297|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195298|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195299|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195300|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195301|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195302|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195303|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195304|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195305|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195306|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195307|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195308|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195309|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195310|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195311|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195312|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195313|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195314|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195315|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195316|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195317|NCT01391013|E2|Reported Event|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
195318|NCT01391013|E1|Reported Event|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
195319|NCT01391000|B3|Baseline|Total|Total of all reporting groups
195320|NCT01391000|B2|Baseline|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
195321|NCT01391000|B1|Baseline|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
195322|NCT01391000|P2|Participant Flow|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
195323|NCT01391000|P1|Participant Flow|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
195324|NCT01391000|O2|Outcome|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
195325|NCT01391000|O1|Outcome|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
195326|NCT01391000|O2|Outcome|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
195327|NCT01391000|O1|Outcome|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
195328|NCT01391000|O2|Outcome|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
195329|NCT01391000|O1|Outcome|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
195330|NCT01391000|E2|Reported Event|TENS|"TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
195331|NCT01391000|E1|Reported Event|Laser CO2|LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
195332|NCT01390948|B4|Baseline|Total|Total of all reporting groups
195333|NCT01390948|B3|Baseline|Bevacizumab + TMZ Young Patient Cohort (YPC)|Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195334|NCT01390948|B2|Baseline|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195335|NCT01390948|B1|Baseline|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195336|NCT01390948|P3|Participant Flow|Bevacizumab + TMZ Young Patient Cohort (YPC)|Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195337|NCT01390948|P2|Participant Flow|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks throughout the entire treatment period.
195338|NCT01390948|P1|Participant Flow|Chemoradiation + TMZ|Participants received a total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 milligrams per meter squared (mg/m^2) TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195339|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195340|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195341|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195342|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195343|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195344|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195345|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
196309|NCT01388816|E2|Reported Event|DRL-17822 50 mg|Once daily after breakfast
195346|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195347|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195348|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195349|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195350|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195351|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195352|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195353|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195354|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195355|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195356|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195357|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195358|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195359|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195360|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195361|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195362|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195363|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195364|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195365|NCT01390948|O2|Outcome|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195366|NCT01390948|O1|Outcome|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195367|NCT01390948|E3|Reported Event|Bevacizumab + TMZ Young Patient Cohort (YPC)|Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195368|NCT01390948|E2|Reported Event|Chemoradiation + Bevacizumab + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
195369|NCT01390948|E1|Reported Event|Chemoradiation + TMZ|Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
195370|NCT01390909|B7|Baseline|Total|Total of all reporting groups
195371|NCT01390909|B6|Baseline|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
195372|NCT01390909|B5|Baseline|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (602 participants) were matched with participant records in the Medicaid, well-controlled cohort.
195373|NCT01390909|B4|Baseline|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
195374|NCT01390909|B3|Baseline|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
195375|NCT01390909|B2|Baseline|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (3454 participants) were matched with participant records in the Medicaid, well-controlled cohort.
195376|NCT01390909|B1|Baseline|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
195377|NCT01390909|P6|Participant Flow|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
195378|NCT01390909|P5|Participant Flow|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
195379|NCT01390909|P4|Participant Flow|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
195380|NCT01390909|P3|Participant Flow|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
195381|NCT01390909|P2|Participant Flow|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
195382|NCT01390909|P1|Participant Flow|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
195383|NCT01390909|O8|Outcome|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
195384|NCT01390909|O7|Outcome|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy.
195385|NCT01390909|O6|Outcome|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
195386|NCT01390909|O5|Outcome|Private, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort.
195387|NCT01390909|O4|Outcome|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
195388|NCT01390909|O3|Outcome|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy
195389|NCT01390909|O2|Outcome|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
195390|NCT01390909|O1|Outcome|Medicaid, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort
195391|NCT01390909|E8|Reported Event|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
195392|NCT01390909|E7|Reported Event|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy.
195393|NCT01390909|E6|Reported Event|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
195394|NCT01390909|E5|Reported Event|Private, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort.
195395|NCT01390909|E4|Reported Event|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
195396|NCT01390909|E3|Reported Event|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy
195397|NCT01390909|E2|Reported Event|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
195838|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195398|NCT01390909|E1|Reported Event|Medicaid, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort
195399|NCT01390870|B1|Baseline|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
195400|NCT01390870|P1|Participant Flow|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
195401|NCT01390870|O1|Outcome|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
195402|NCT01390870|E1|Reported Event|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
195403|NCT01390857|B1|Baseline|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
195404|NCT01390857|P1|Participant Flow|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
195405|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
195406|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
195407|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
195408|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
195409|NCT01390857|E1|Reported Event|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
195410|NCT01390844|B5|Baseline|Total|Total of all reporting groups
195411|NCT01390844|B4|Baseline|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195412|NCT01390844|B3|Baseline|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195413|NCT01390844|B2|Baseline|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195414|NCT01390844|B1|Baseline|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195415|NCT01390844|P4|Participant Flow|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195416|NCT01390844|P3|Participant Flow|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195417|NCT01390844|P2|Participant Flow|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195418|NCT01390844|P1|Participant Flow|Boceprevir - Korea+Taiwan|PegIntron (pegylated interferon alfa-2b) (PEG) + ribavirin (RBV) for 4 weeks followed by boceprevir (BOC) + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195419|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195420|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195421|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195422|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195423|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195424|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195425|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195426|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195427|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195428|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195429|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195459|NCT01390818|P15|Participant Flow|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195430|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195431|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195432|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195433|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195434|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195435|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195436|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195437|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195438|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195439|NCT01390844|E4|Reported Event|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195440|NCT01390844|E3|Reported Event|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195441|NCT01390844|E2|Reported Event|Control - Korea + Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
195460|NCT01390818|P14|Participant Flow|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195442|NCT01390844|E1|Reported Event|Boceprevir - Korea + Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
195443|NCT01390818|B16|Baseline|Total|Total of all reporting groups
195444|NCT01390818|B15|Baseline|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195445|NCT01390818|B14|Baseline|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195446|NCT01390818|B13|Baseline|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195447|NCT01390818|B12|Baseline|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195448|NCT01390818|B11|Baseline|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195449|NCT01390818|B10|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195450|NCT01390818|B9|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195451|NCT01390818|B8|Baseline|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195452|NCT01390818|B7|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195453|NCT01390818|B6|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195454|NCT01390818|B5|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195455|NCT01390818|B4|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195456|NCT01390818|B3|Baseline|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195457|NCT01390818|B2|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195458|NCT01390818|B1|Baseline|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195904|NCT01390389|P1|Participant Flow|Control|Healthy controls with no evidence of current or past psychiatric disorders.
195461|NCT01390818|P13|Participant Flow|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195462|NCT01390818|P12|Participant Flow|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195463|NCT01390818|P11|Participant Flow|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195464|NCT01390818|P10|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195465|NCT01390818|P9|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195466|NCT01390818|P8|Participant Flow|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195467|NCT01390818|P7|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195468|NCT01390818|P6|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195469|NCT01390818|P5|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195470|NCT01390818|P4|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195471|NCT01390818|P3|Participant Flow|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195472|NCT01390818|P2|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195473|NCT01390818|P1|Participant Flow|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (Dose Escalation [DE] cohort).
195474|NCT01390818|O15|Outcome|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195475|NCT01390818|O14|Outcome|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195476|NCT01390818|O13|Outcome|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195517|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195477|NCT01390818|O12|Outcome|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195478|NCT01390818|O11|Outcome|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195479|NCT01390818|O10|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195480|NCT01390818|O9|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195481|NCT01390818|O8|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195482|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195483|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195484|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195485|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195486|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195487|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195488|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195489|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195490|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195491|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject
195492|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195493|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195494|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195495|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195496|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195497|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195498|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject
195499|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195500|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195501|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195502|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195503|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195504|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195505|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195506|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195507|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195508|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195509|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195510|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195511|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195512|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195513|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195514|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195515|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195516|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195518|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195519|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195520|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195521|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195522|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195523|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195524|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195525|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195526|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195527|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195528|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195529|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195530|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195531|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195532|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195533|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195534|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195535|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195536|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195537|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195538|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195539|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195540|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195541|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195831|NCT01390428|P4|Participant Flow|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195542|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195543|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195544|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195545|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195546|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195547|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195548|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195549|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195550|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195551|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195552|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195553|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195554|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195555|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195556|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195557|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195558|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195559|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195560|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195561|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195562|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195563|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195564|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195565|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
196237|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
195566|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195567|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195568|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195569|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195570|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195571|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195572|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195573|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195574|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195575|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195576|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195577|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195578|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195579|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195580|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195581|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195582|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195583|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195584|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195585|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195586|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195587|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195588|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195589|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195832|NCT01390428|P3|Participant Flow|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195590|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195591|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195592|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195593|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195594|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195595|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195596|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195597|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195598|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195599|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195600|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195601|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195602|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195603|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195604|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195605|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195606|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195607|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195608|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195609|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195610|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195611|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195612|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195613|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195614|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195615|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195616|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195617|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195618|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195619|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195620|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195621|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195622|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195623|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195624|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195625|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195626|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195627|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195628|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195629|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195630|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195631|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195632|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195633|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195634|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195635|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195636|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195637|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195638|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195639|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195640|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195641|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195642|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195643|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195644|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195645|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195646|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195647|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195648|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195649|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195650|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195651|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195652|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195653|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195654|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195655|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195656|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195657|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195658|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195659|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195660|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195661|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195662|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195663|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195664|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195665|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195666|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195667|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195668|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195669|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195670|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195671|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195672|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
195673|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195674|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195675|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195676|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195677|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195678|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195679|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195680|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195681|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195682|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195683|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195684|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195685|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195686|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195687|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195688|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195689|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195690|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195691|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195692|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195693|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195694|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195695|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195696|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
195697|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195698|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195699|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195700|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195701|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195702|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195703|NCT01390818|O15|Outcome|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195704|NCT01390818|O14|Outcome|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195705|NCT01390818|O13|Outcome|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195706|NCT01390818|O12|Outcome|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
195707|NCT01390818|O11|Outcome|MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195708|NCT01390818|O10|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195709|NCT01390818|O9|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195710|NCT01390818|O8|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195711|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195712|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195713|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195714|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195715|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195716|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195717|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195718|NCT01390818|O11|Outcome|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195719|NCT01390818|O10|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195720|NCT01390818|O9|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195721|NCT01390818|O8|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195833|NCT01390428|P2|Participant Flow|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195722|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195723|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195724|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195725|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195726|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195727|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195728|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
195729|NCT01390818|E15|Reported Event|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
195730|NCT01390818|E14|Reported Event|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
195731|NCT01390818|E13|Reported Event|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
195732|NCT01390818|E12|Reported Event|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
195733|NCT01390818|E11|Reported Event|MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily|MSC1936369B (Pimasertib) capsule administered twice at a dose of 45 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
195734|NCT01390818|E10|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily|MSC1936369B (Pimasertib) capsule administered twice at a dose of 60 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
195735|NCT01390818|E9|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) (DE cohort).
195736|NCT01390818|E8|Reported Event|MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
195737|NCT01390818|E7|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
195738|NCT01390818|E6|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
195739|NCT01390818|E5|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
195834|NCT01390428|P1|Participant Flow|Part 1-Mild Hepatic Impairment (HI)|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195740|NCT01390818|E4|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
195741|NCT01390818|E3|Reported Event|MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 15 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
195742|NCT01390818|E2|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
195743|NCT01390818|E1|Reported Event|MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 15 milligram (mg) on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
195744|NCT01390779|B1|Baseline|SENSIMED Triggerfish|
195745|NCT01390779|P1|Participant Flow|SENSIMED Triggerfish|"All subjects enrolled in the trial were housed in a sleep laboratory for 24 hours, during which they underwent SENSIMED Triggerfish recording on one randomly selected eye.
Parallel IOP measurements were taken using pneumatonometry on the eye contralateral to the SENSIMED Triggerfish eye before and after sleep onset. During sleep heart rate measurements were collected at specified time points."
195746|NCT01390779|O1|Outcome|SENSIMED Triggerfish|
195747|NCT01390779|O1|Outcome|SENSIMED Triggerfish|
195748|NCT01390779|E1|Reported Event|SENSIMED Triggerfish|
195749|NCT01390649|B1|Baseline|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
195750|NCT01390649|P1|Participant Flow|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
195751|NCT01390649|O1|Outcome|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
195752|NCT01390649|O1|Outcome|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
195753|NCT01390649|E1|Reported Event|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
195754|NCT01390441|B6|Baseline|Total|Total of all reporting groups
195755|NCT01390441|B5|Baseline|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195756|NCT01390441|B4|Baseline|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195757|NCT01390441|B3|Baseline|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195758|NCT01390441|B2|Baseline|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195759|NCT01390441|B1|Baseline|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195760|NCT01390441|P5|Participant Flow|Part B: Rituxan® 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195761|NCT01390441|P4|Participant Flow|Part B: MabThera® 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195762|NCT01390441|P3|Participant Flow|Part B: MK-8808 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195763|NCT01390441|P2|Participant Flow|Part A: MabThera® 500 mg/m^2 / Extension A: MK-8808 1000 mg|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195835|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195764|NCT01390441|P1|Participant Flow|Part A: MK-8808 500 mg/m^2 / Extension A: MK-8808 1000 mg|Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or intramuscularly (IM) for the duration of the trial.
195765|NCT01390441|O5|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195766|NCT01390441|O4|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195767|NCT01390441|O3|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195768|NCT01390441|O2|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195769|NCT01390441|O1|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195770|NCT01390441|O5|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195771|NCT01390441|O4|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195772|NCT01390441|O3|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195773|NCT01390441|O2|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195774|NCT01390441|O1|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195775|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195776|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or IM for the duration of the trial.
195777|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195778|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195779|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195780|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195781|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously SC, or IM for the duration of the trial.
195782|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195783|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195836|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195784|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195785|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195786|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195787|NCT01390441|O10|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195788|NCT01390441|O9|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195789|NCT01390441|O8|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195790|NCT01390441|O7|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195791|NCT01390441|O6|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195792|NCT01390441|O5|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195793|NCT01390441|O4|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195794|NCT01390441|O3|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195795|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195796|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195797|NCT01390441|O10|Outcome|Extension B: Rituxan1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195798|NCT01390441|O9|Outcome|Extension B: MabThera 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195799|NCT01390441|O8|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195800|NCT01390441|O7|Outcome|Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195801|NCT01390441|O6|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195802|NCT01390441|O5|Outcome|Part B: Rituxan 1000 mg|Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195803|NCT01390441|O4|Outcome|Part B: MabThera 1000 mg|Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195804|NCT01390441|O3|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195837|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195805|NCT01390441|O2|Outcome|Part A: MabThera 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195806|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195807|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195808|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195809|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195810|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195811|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195812|NCT01390441|E10|Reported Event|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195813|NCT01390441|E9|Reported Event|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195814|NCT01390441|E8|Reported Event|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195815|NCT01390441|E7|Reported Event|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195816|NCT01390441|E6|Reported Event|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195817|NCT01390441|E5|Reported Event|Part B: Rituxan 1000 mg|Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195818|NCT01390441|E4|Reported Event|Part B: MabThera 1000 mg|Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195819|NCT01390441|E3|Reported Event|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195820|NCT01390441|E2|Reported Event|Part A: MabThera 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195821|NCT01390441|E1|Reported Event|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
195822|NCT01390428|B7|Baseline|Total|Total of all reporting groups
195823|NCT01390428|B6|Baseline|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195824|NCT01390428|B5|Baseline|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195825|NCT01390428|B4|Baseline|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195826|NCT01390428|B3|Baseline|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195827|NCT01390428|B2|Baseline|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195828|NCT01390428|B1|Baseline|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195829|NCT01390428|P6|Participant Flow|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195830|NCT01390428|P5|Participant Flow|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195839|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195840|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195841|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195842|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195843|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195844|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195845|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195846|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195847|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195848|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195849|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195850|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195851|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195852|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195853|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195854|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195855|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195856|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195857|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195858|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195859|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195860|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195861|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195862|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195863|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195864|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195865|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195866|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195867|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195868|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195869|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195870|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195871|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195872|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195873|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195874|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195875|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195876|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195877|NCT01390428|E6|Reported Event|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195878|NCT01390428|E5|Reported Event|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
195879|NCT01390428|E4|Reported Event|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195880|NCT01390428|E3|Reported Event|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
195881|NCT01390428|E2|Reported Event|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195882|NCT01390428|E1|Reported Event|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
195883|NCT01390415|B3|Baseline|Total|Total of all reporting groups
195884|NCT01390415|B2|Baseline|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195885|NCT01390415|B1|Baseline|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195886|NCT01390415|P2|Participant Flow|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195887|NCT01390415|P1|Participant Flow|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195888|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195889|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195890|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195891|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195892|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195893|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195894|NCT01390415|E2|Reported Event|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195895|NCT01390415|E1|Reported Event|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
195896|NCT01390402|B1|Baseline|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
195897|NCT01390402|P1|Participant Flow|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
195898|NCT01390402|O1|Outcome|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
195899|NCT01390402|E1|Reported Event|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
195900|NCT01390389|B3|Baseline|Total|Total of all reporting groups
195901|NCT01390389|B2|Baseline|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
195902|NCT01390389|B1|Baseline|Control|Healthy controls with no evidence of current or past psychiatric disorders.
195903|NCT01390389|P2|Participant Flow|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
195905|NCT01390389|O2|Outcome|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
195906|NCT01390389|O1|Outcome|Control|Healthy controls with no evidence of current or past psychiatric disorders.
195907|NCT01390389|E2|Reported Event|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
195908|NCT01390389|E1|Reported Event|Control|Healthy controls with no evidence of current or past psychiatric disorders.
195909|NCT01390259|B1|Baseline|Adolescents|"Adolescents participated in both the Standard Control to Range (sCTR) Closed-Loop Control (CLC) Admission and the Open-Loop admission.
Experimental: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:
monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Placebo Comparator: Open Loop. The subjects were in charge of their insulin treatment."
195910|NCT01390259|P2|Participant Flow|Closed-Loop Control First, Then Open-Loop|"Closed-Loop control (CLC) first, then Open-Loop
Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:
monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment."
195911|NCT01390259|P1|Participant Flow|Open-Loop First, Then Closed-Loop|"Open-Loop first, then Closed-Loop control (CLC)
Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:
monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment."
195912|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.
Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
195913|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:
monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
195914|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.
Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
195915|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:
monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
195916|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.
Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
195917|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:
monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
196310|NCT01388816|E1|Reported Event|Placebo Capsule|Once daily after breakfast
195918|NCT01390259|E1|Reported Event|Adolescents|"Adolescents participated in both the Standard Control to Range (sCTR) Closed-Loop Control (CLC) Admission and the Open-Loop admission.
Experimental: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:
monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
Placebo Comparator: Open Loop. The subjects were in charge of their insulin treatment."
195919|NCT01390233|B4|Baseline|Total|Total of all reporting groups
195920|NCT01390233|B3|Baseline|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
195921|NCT01390233|B2|Baseline|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
195922|NCT01390233|B1|Baseline|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
195923|NCT01390233|P3|Participant Flow|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
195924|NCT01390233|P2|Participant Flow|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
195925|NCT01390233|P1|Participant Flow|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
195926|NCT01390233|O3|Outcome|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
195927|NCT01390233|O2|Outcome|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
195951|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
195952|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
195928|NCT01390233|O1|Outcome|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
195929|NCT01390233|E3|Reported Event|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
195930|NCT01390233|E2|Reported Event|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
195931|NCT01390233|E1|Reported Event|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
195932|NCT01390181|B1|Baseline|Losartan|Cozaar: Angiotensin II Receptor Blocker
195933|NCT01390181|P1|Participant Flow|Losartan|Cozaar: Angiotensin II Receptor Blocker
195934|NCT01390181|O1|Outcome|Losartan|Cozaar: Angiotensin II Receptor Blocker
195935|NCT01390181|E1|Reported Event|Losartan|Cozaar: Angiotensin II Receptor Blocker
195936|NCT01390038|B1|Baseline|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
195937|NCT01390038|P1|Participant Flow|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
195938|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
195939|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
195940|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
195941|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
195942|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
195943|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
195944|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
195945|NCT01390038|E1|Reported Event|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
195946|NCT01389973|B1|Baseline|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
195947|NCT01389973|P1|Participant Flow|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
195948|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
195949|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
195950|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
195953|NCT01389973|E1|Reported Event|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
195954|NCT01389882|B3|Baseline|Total|Total of all reporting groups
195955|NCT01389882|B2|Baseline|NS Group|NAVA first, then SIMV with PS
195956|NCT01389882|B1|Baseline|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
195957|NCT01389882|P2|Participant Flow|NS Group|NAVA first, then SIMV with PS
195958|NCT01389882|P1|Participant Flow|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
195959|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195960|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195961|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195962|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195963|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195964|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195965|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195966|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195967|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195968|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195969|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195970|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195971|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195972|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195973|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195974|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195975|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195976|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195977|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195978|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195979|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195980|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195981|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
195982|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
195983|NCT01389882|E2|Reported Event|NS Group|NAVA first, then SIMV with PS
195984|NCT01389882|E1|Reported Event|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
195985|NCT01389856|B3|Baseline|Total|Total of all reporting groups
195986|NCT01389856|B2|Baseline|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
195987|NCT01389856|B1|Baseline|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
195988|NCT01389856|P2|Participant Flow|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
195989|NCT01389856|P1|Participant Flow|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
195990|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
195991|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
195992|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
195993|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
195994|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
195995|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
195996|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
195997|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
195998|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
195999|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196372|NCT01388361|B4|Baseline|Total|Total of all reporting groups
196000|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196001|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196002|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196003|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196004|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196005|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196006|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196007|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196008|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196009|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196010|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196011|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196012|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196013|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196014|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196015|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196016|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196017|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196018|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196019|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196020|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196021|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196022|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196023|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196024|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196025|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196026|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196027|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196028|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196029|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196030|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196238|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196031|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196032|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196033|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196034|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196035|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196036|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196037|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196038|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196039|NCT01389856|O2|Outcome|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196040|NCT01389856|O1|Outcome|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196041|NCT01389856|E2|Reported Event|Placebo|"Matching placebo
Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
196042|NCT01389856|E1|Reported Event|Bosentan|"Bosentan
Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
196043|NCT01389817|B3|Baseline|Total|Total of all reporting groups
196044|NCT01389817|B2|Baseline|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
196045|NCT01389817|B1|Baseline|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).
Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
196046|NCT01389817|P2|Participant Flow|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
196047|NCT01389817|P1|Participant Flow|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).
Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
196048|NCT01389817|O2|Outcome|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
196049|NCT01389817|O1|Outcome|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).
Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
196050|NCT01389817|E2|Reported Event|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
196051|NCT01389817|E1|Reported Event|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).
Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
196052|NCT01389596|B4|Baseline|Total|Total of all reporting groups
196053|NCT01389596|B3|Baseline|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196054|NCT01389596|B2|Baseline|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196055|NCT01389596|B1|Baseline|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196056|NCT01389596|P3|Participant Flow|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196057|NCT01389596|P2|Participant Flow|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196058|NCT01389596|P1|Participant Flow|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and less than (<) 30 kilograms (kg) in weight, received pregabalin 3.5 milligram per kilogram per day (mg/kg/day) (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and greater than or equal to (>=) 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196059|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196060|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196061|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196062|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196063|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196064|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196065|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196066|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196067|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196143|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196068|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196069|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196070|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196071|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196072|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196073|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196074|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196075|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196076|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196077|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196078|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196079|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196080|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196081|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196082|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196083|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196084|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196085|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196086|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196087|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196088|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196089|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196090|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196091|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196092|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196093|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196094|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196095|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196096|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196097|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196098|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196099|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196100|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196101|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196102|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196103|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196104|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196105|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196106|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196107|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196108|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196109|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196110|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196111|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196112|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196113|NCT01389596|E3|Reported Event|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
196114|NCT01389596|E2|Reported Event|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196115|NCT01389596|E1|Reported Event|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
196116|NCT01389323|B1|Baseline|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
196117|NCT01389323|P1|Participant Flow|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
196118|NCT01389323|O5|Outcome|Overall Population|Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
196119|NCT01389323|O4|Outcome|Non-Latino Cohort|Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
196120|NCT01389323|O3|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
196121|NCT01389323|O2|Outcome|White/Caucasian Cohort|Participants belonging to White/Caucasian race, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
196139|NCT01389284|B1|Baseline|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196140|NCT01389284|P3|Participant Flow|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196232|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196122|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
196123|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
196124|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
196125|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
196126|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
196127|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
196128|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
196141|NCT01389284|P2|Participant Flow|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196142|NCT01389284|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196233|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196129|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
196130|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
196131|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
196132|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
196133|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
196134|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
196135|NCT01389323|E1|Reported Event|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
196136|NCT01389284|B4|Baseline|Total|Total of all reporting groups
196137|NCT01389284|B3|Baseline|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196138|NCT01389284|B2|Baseline|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196234|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196144|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196145|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196146|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196147|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196148|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196149|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196150|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196151|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196152|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196153|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196154|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196155|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196156|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196157|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196158|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196159|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196160|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196161|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196162|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196163|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196164|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196165|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196235|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196293|NCT01388816|O2|Outcome|DRL-17822 150 mg|Once daily after breakfast
196166|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196167|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196168|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196169|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196170|NCT01389284|E3|Reported Event|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196171|NCT01389284|E2|Reported Event|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
196172|NCT01389284|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
196173|NCT01389102|B7|Baseline|Total|Total of all reporting groups
196174|NCT01389102|B6|Baseline|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
196175|NCT01389102|B5|Baseline|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196176|NCT01389102|B4|Baseline|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196177|NCT01389102|B3|Baseline|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
196178|NCT01389102|B2|Baseline|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196179|NCT01389102|B1|Baseline|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196180|NCT01389102|P6|Participant Flow|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
196181|NCT01389102|P5|Participant Flow|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196182|NCT01389102|P4|Participant Flow|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196183|NCT01389102|P3|Participant Flow|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
196184|NCT01389102|P2|Participant Flow|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196185|NCT01389102|P1|Participant Flow|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196186|NCT01389102|O6|Outcome|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
196187|NCT01389102|O5|Outcome|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196188|NCT01389102|O4|Outcome|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196189|NCT01389102|O3|Outcome|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
196190|NCT01389102|O2|Outcome|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196191|NCT01389102|O1|Outcome|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196192|NCT01389102|O6|Outcome|Estradiol Transdermal One 90 μL Spray|
196193|NCT01389102|O5|Outcome|Estradiol Transdermal Two 90 μL Sprays|
196194|NCT01389102|O4|Outcome|Estradiol Transdermal Three 90 μL Sprays|
196195|NCT01389102|O3|Outcome|Placebo Transdermal One 90 μL Spray|
196196|NCT01389102|O2|Outcome|Placebo Transdermal Two 90 μL Sprays|
196197|NCT01389102|O1|Outcome|Placebo Transdermal Three 90 μL Sprays|
196198|NCT01389102|E6|Reported Event|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
196199|NCT01389102|E5|Reported Event|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196200|NCT01389102|E4|Reported Event|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196201|NCT01389102|E3|Reported Event|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
196202|NCT01389102|E2|Reported Event|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196203|NCT01389102|E1|Reported Event|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
196204|NCT01389076|B1|Baseline|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)
Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.
On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
196205|NCT01389076|P1|Participant Flow|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)
Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.
On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
196206|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)
Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.
On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
196207|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)
Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.
On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
196208|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)
Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.
On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
196209|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)
Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.
On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
196210|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)
Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.
On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
196211|NCT01389076|E1|Reported Event|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)
Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.
On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
196212|NCT01388946|B3|Baseline|Total|Total of all reporting groups
196213|NCT01388946|B2|Baseline|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196214|NCT01388946|B1|Baseline|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196215|NCT01388946|P2|Participant Flow|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196216|NCT01388946|P1|Participant Flow|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196217|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196218|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196219|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196220|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196221|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196222|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196223|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196224|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196225|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196226|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196227|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196228|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196229|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196230|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196231|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196239|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196240|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196241|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196242|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196243|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196244|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196245|NCT01388946|E2|Reported Event|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline"
196246|NCT01388946|E1|Reported Event|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75"
196247|NCT01388920|B4|Baseline|Total|Total of all reporting groups
196248|NCT01388920|B3|Baseline|Placebo|Placebo for 6 months
196249|NCT01388920|B2|Baseline|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
196250|NCT01388920|B1|Baseline|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
196251|NCT01388920|P3|Participant Flow|Placebo|Placebo for 6 monts
196252|NCT01388920|P2|Participant Flow|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
196253|NCT01388920|P1|Participant Flow|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
196254|NCT01388920|O3|Outcome|Placebo|Placebo for 6 months
196255|NCT01388920|O2|Outcome|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
196256|NCT01388920|O1|Outcome|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
196257|NCT01388920|E3|Reported Event|Placebo|Placebo for 6 months
196258|NCT01388920|E2|Reported Event|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
196259|NCT01388920|E1|Reported Event|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
196260|NCT01388907|B3|Baseline|Total|Total of all reporting groups
196261|NCT01388907|B2|Baseline|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
196262|NCT01388907|B1|Baseline|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
196263|NCT01388907|P2|Participant Flow|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
196264|NCT01388907|P1|Participant Flow|Prevadh™ (P) Group|Patients randomized in the Prevadh group have been treated with Prevadh film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
196265|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
196266|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
196267|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
196268|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
196269|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
196270|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Patients randomized in the Prevadh group have been treated with Prevadh film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
196271|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
196272|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
196273|NCT01388907|E2|Reported Event|Ringer Lactate™ (R) Group With Adverse Event|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
196274|NCT01388907|E1|Reported Event|Prevadh™ (P) Group With Adverse Event|Patients randomized in the Prevadh group have been treated with Prevadh Film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
196275|NCT01388816|B5|Baseline|Total|Total of all reporting groups
196276|NCT01388816|B4|Baseline|DRL-17822 300 mg|Once daily after breakfast
196277|NCT01388816|B3|Baseline|DRL-17822 150 mg|Once daily after breakfast
196278|NCT01388816|B2|Baseline|DRL-17822 50 mg|Once daily after breakfast
196279|NCT01388816|B1|Baseline|Placebo Capsule|Once daily after breakfast
196280|NCT01388816|P4|Participant Flow|DRL-17822 300 mg|Once daily after breakfast
196281|NCT01388816|P3|Participant Flow|DRL-17822 150 mg|Once daily after breakfast
196282|NCT01388816|P2|Participant Flow|DRL-17822 50 mg|Once daily after breakfast
196283|NCT01388816|P1|Participant Flow|Placebo|Once daily after breakfast
196284|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
196285|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
196286|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
196287|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
196288|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
196289|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
196290|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
196291|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
196292|NCT01388816|O3|Outcome|DRL-17822 300 mg|Once daily after breakfast
196311|NCT01388790|B1|Baseline|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
196312|NCT01388790|P1|Participant Flow|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
196313|NCT01388790|O1|Outcome|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
196314|NCT01388790|O1|Outcome|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
196315|NCT01388790|E1|Reported Event|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
196316|NCT01388647|B3|Baseline|Total|Total of all reporting groups
196317|NCT01388647|B2|Baseline|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
196318|NCT01388647|B1|Baseline|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
196319|NCT01388647|P2|Participant Flow|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
196320|NCT01388647|P1|Participant Flow|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
196321|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
196322|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
196323|NCT01388647|O1|Outcome|All Study Participants|All subjects were assigned to receive either a starting dose of eribulin 1.1 mg/m^2 or eribulin 1.4 mg/m^2.
196324|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
196325|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
196326|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
196327|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
196328|NCT01388647|E2|Reported Event|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
196329|NCT01388647|E1|Reported Event|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
196330|NCT01388530|B1|Baseline|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
196331|NCT01388530|P1|Participant Flow|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
196332|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
196333|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
196334|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
196335|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
196336|NCT01388530|E1|Reported Event|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.
EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
196337|NCT01388491|B3|Baseline|Total|Total of all reporting groups
196338|NCT01388491|B2|Baseline|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196339|NCT01388491|B1|Baseline|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196340|NCT01388491|P2|Participant Flow|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196341|NCT01388491|P1|Participant Flow|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196342|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196343|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196344|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196345|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196346|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196347|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196348|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196349|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196350|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196351|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196352|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196353|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196354|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196355|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196356|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196357|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196358|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196359|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196360|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196361|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196362|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196363|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196364|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196365|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196366|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196367|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196368|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196369|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196370|NCT01388491|E2|Reported Event|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
196371|NCT01388491|E1|Reported Event|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
196373|NCT01388361|B3|Baseline|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196374|NCT01388361|B2|Baseline|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196375|NCT01388361|B1|Baseline|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
196376|NCT01388361|P3|Participant Flow|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196377|NCT01388361|P2|Participant Flow|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196378|NCT01388361|P1|Participant Flow|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
196379|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196380|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196381|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
196382|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196383|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196384|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
196385|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196386|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196387|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
196416|NCT01387737|P1|Participant Flow|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
196417|NCT01387737|O2|Outcome|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
196388|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196389|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196390|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
196391|NCT01388361|E3|Reported Event|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196392|NCT01388361|E2|Reported Event|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
196393|NCT01388361|E1|Reported Event|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
196394|NCT01388166|B1|Baseline|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
196395|NCT01388166|P1|Participant Flow|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
196396|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
196397|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
196398|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
196399|NCT01388166|E1|Reported Event|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) at least 1 months and within product label.
196400|NCT01387789|B1|Baseline|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196401|NCT01387789|P1|Participant Flow|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196402|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196403|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196404|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196405|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196406|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196407|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196408|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196409|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196410|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196411|NCT01387789|E1|Reported Event|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
196412|NCT01387737|B3|Baseline|Total|Total of all reporting groups
196413|NCT01387737|B2|Baseline|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
196414|NCT01387737|B1|Baseline|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
196415|NCT01387737|P2|Participant Flow|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
196418|NCT01387737|O1|Outcome|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
196419|NCT01387737|E2|Reported Event|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
196420|NCT01387737|E1|Reported Event|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
196421|NCT01387672|B7|Baseline|Total|Total of all reporting groups
196422|NCT01387672|B6|Baseline|Placebo Ointment - Treatment Arm 6|"Placebo Ointment
Placebo: Placebo ointment Nitrates (NABT Main trial)"
196423|NCT01387672|B5|Baseline|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet
Nitrates (NABT Main trial)"
196424|NCT01387672|B4|Baseline|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet
Nitrates (NABT Main trial)"
196425|NCT01387672|B3|Baseline|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP
Nitrates (NABT Main trial)"
196426|NCT01387672|B2|Baseline|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg
Nitrates (NABT Main trial)"
196427|NCT01387672|B1|Baseline|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet
Nitrates (NABT Main trial)"
196428|NCT01387672|P6|Participant Flow|Placebo Ointment - Treatment Arm 6|"Placebo Ointment
Nitrates (NABT Main trial)"
196429|NCT01387672|P5|Participant Flow|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet
Nitrates (NABT Main trial)"
196430|NCT01387672|P4|Participant Flow|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet
Nitrates (NABT Main trial)"
196431|NCT01387672|P3|Participant Flow|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP
Nitrates (NABT Main trial)"
196432|NCT01387672|P2|Participant Flow|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg
Nitrates (NABT Main trial)"
196433|NCT01387672|P1|Participant Flow|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet
Nitrates (NABT Main trial)"
196434|NCT01387672|O1|Outcome|Run-in Phase|During the run-in phase subjects received, in random order, each of the 5 nitrate formulations for 2 days with a 2 day wash out period between formulations. The severity of headaches was recorded, by subjects, upon awakening, every day during the run in phase using a visual analog scale (VAS).
196435|NCT01387672|O6|Outcome|Placebo Ointment - Treatment Arm 6|"Placebo Ointment
Placebo: Placebo ointment Nitrates (NABT Main trial)"
196436|NCT01387672|O5|Outcome|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet
Nitrates (NABT Main trial)"
196437|NCT01387672|O4|Outcome|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet
Nitrates (NABT Main trial)"
196438|NCT01387672|O3|Outcome|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP
Nitrates (NABT Main trial)"
196439|NCT01387672|O2|Outcome|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg
Nitrates (NABT Main trial)"
196440|NCT01387672|O1|Outcome|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet
Nitrates (NABT Main trial)"
196441|NCT01387672|E6|Reported Event|Placebo Ointment- Treatment Arm 6|"Placebo Ointment
Placebo: Placebo ointment Nitrates (NABT Main trial)"
196442|NCT01387672|E5|Reported Event|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet
Nitrates (NABT Main trial)"
196443|NCT01387672|E4|Reported Event|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet
Nitrates (NABT Main trial)"
196444|NCT01387672|E3|Reported Event|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP
Nitrates (NABT Main trial)"
196445|NCT01387672|E2|Reported Event|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg
Nitrates (NABT Main trial)"
196446|NCT01387672|E1|Reported Event|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet
Nitrates (NABT Main trial)"
196447|NCT01387594|B3|Baseline|Total|Total of all reporting groups
196448|NCT01387594|B2|Baseline|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196449|NCT01387594|B1|Baseline|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196450|NCT01387594|P2|Participant Flow|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196451|NCT01387594|P1|Participant Flow|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196452|NCT01387594|O2|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196474|NCT01387581|O1|Outcome|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
196453|NCT01387594|O1|Outcome|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196454|NCT01387594|O2|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196455|NCT01387594|O1|Outcome|Cohort 1: PF-00547659|Participants who had Crohns disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196456|NCT01387594|O2|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196457|NCT01387594|O1|Outcome|Cohort 1: PF-00547659|Participants who had CD and who satisfied all study entry criteria were enrolled into the study. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). 2 LPs were to be performed during participation. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196458|NCT01387594|O1|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196459|NCT01387594|O1|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196460|NCT01387594|E2|Reported Event|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196461|NCT01387594|E1|Reported Event|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
196462|NCT01387581|B4|Baseline|Total|Total of all reporting groups
196463|NCT01387581|B3|Baseline|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
196464|NCT01387581|B2|Baseline|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
196465|NCT01387581|B1|Baseline|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
196466|NCT01387581|P3|Participant Flow|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
196467|NCT01387581|P2|Participant Flow|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
196468|NCT01387581|P1|Participant Flow|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
196469|NCT01387581|O3|Outcome|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
196470|NCT01387581|O2|Outcome|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
196471|NCT01387581|O1|Outcome|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
196472|NCT01387581|O3|Outcome|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
196473|NCT01387581|O2|Outcome|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
196475|NCT01387581|E3|Reported Event|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
196476|NCT01387581|E2|Reported Event|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
196477|NCT01387581|E1|Reported Event|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
196478|NCT01387542|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
196479|NCT01387542|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
196480|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
196481|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
196482|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
196483|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
196484|NCT01387542|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
196485|NCT01387464|B3|Baseline|Total|Total of all reporting groups
196486|NCT01387464|B2|Baseline|Bromday|0.09% bromfenac dosed QD
196487|NCT01387464|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
196488|NCT01387464|P2|Participant Flow|Bromday|0.09% bromfenac dosed QD
196489|NCT01387464|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
196490|NCT01387464|O2|Outcome|Bromday|0.09% bromfenac dosed QD
196491|NCT01387464|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
196492|NCT01387464|E2|Reported Event|Bromday|0.09% bromfenac dosed QD
196493|NCT01387464|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
196494|NCT01387347|B3|Baseline|Total|Total of all reporting groups
196495|NCT01387347|B2|Baseline|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4
Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
196496|NCT01387347|B1|Baseline|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.
Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
196497|NCT01387347|P2|Participant Flow|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4.
Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
196498|NCT01387347|P1|Participant Flow|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.
Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
196499|NCT01387347|O2|Outcome|Thymosin Beta 4|RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye twice a day for 29 days.
196500|NCT01387347|O1|Outcome|Placebo|Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 (w/w) for direct instillation into each eye twice a day for 29 days.
196501|NCT01387347|O2|Outcome|Thymosin Beta 4|Thymosin beta 4 solution is a sterile eye drop solution containing 0.1%(w/w) Tβ4. Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
196502|NCT01387347|O1|Outcome|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.
Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
196503|NCT01387347|O2|Outcome|Placebo|Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0% Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
196504|NCT01387347|O1|Outcome|Thymosin Beta 4|RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
196505|NCT01387347|E2|Reported Event|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4
Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
196506|NCT01387347|E1|Reported Event|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.
Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
196507|NCT01387282|B3|Baseline|Total|Total of all reporting groups
196508|NCT01387282|B2|Baseline|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196509|NCT01387282|B1|Baseline|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196553|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
196510|NCT01387282|P2|Participant Flow|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196511|NCT01387282|P1|Participant Flow|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196512|NCT01387282|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196513|NCT01387282|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196514|NCT01387282|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196515|NCT01387282|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196516|NCT01387282|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196517|NCT01387282|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196518|NCT01387282|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196519|NCT01387282|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196520|NCT01387282|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196521|NCT01387282|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196522|NCT01387282|E2|Reported Event|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196523|NCT01387282|E1|Reported Event|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196524|NCT01387269|B3|Baseline|Total|Total of all reporting groups
196525|NCT01387269|B2|Baseline|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196526|NCT01387269|B1|Baseline|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196527|NCT01387269|P2|Participant Flow|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196528|NCT01387269|P1|Participant Flow|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196529|NCT01387269|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196530|NCT01387269|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196531|NCT01387269|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196532|NCT01387269|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196533|NCT01387269|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196534|NCT01387269|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196535|NCT01387269|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196536|NCT01387269|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196537|NCT01387269|O2|Outcome|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196538|NCT01387269|O1|Outcome|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196539|NCT01387269|E2|Reported Event|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196540|NCT01387269|E1|Reported Event|Anamorelin HCl|Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
196541|NCT01387230|B4|Baseline|Total|Total of all reporting groups
196542|NCT01387230|B3|Baseline|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
196543|NCT01387230|B2|Baseline|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
196544|NCT01387230|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
196545|NCT01387230|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
196546|NCT01387230|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
196547|NCT01387230|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 12 weeks.
196548|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
196549|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
196550|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
196551|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
196552|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
196554|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
196555|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
196556|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
196557|NCT01387230|E3|Reported Event|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
196558|NCT01387230|E2|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
196559|NCT01387230|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
196560|NCT01387178|B3|Baseline|Total|Total of all reporting groups
196561|NCT01387178|B2|Baseline|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
196562|NCT01387178|B1|Baseline|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
196563|NCT01387178|P2|Participant Flow|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for tiotropium bromide (TIO)
196564|NCT01387178|P1|Participant Flow|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Edition, Clinical Modification [ICD-9-CM] code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for fluticasone/propionate 250 µg /50 µg (FSC)
196565|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with &gt;=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), &gt;=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), &gt;=1 in the post-index date observation period, and &gt;=1 prescription claim for TIO
196566|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
196567|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with &gt;=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), &gt;=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), &gt;=1 in the post-index date observation period, and &gt;=1 prescription claim for TIO
196568|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
196569|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
196570|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
196571|NCT01387178|E2|Reported Event|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
196572|NCT01387178|E1|Reported Event|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
196573|NCT01387139|B3|Baseline|Total|Total of all reporting groups
196574|NCT01387139|B2|Baseline|Ketamine Co-Administered With Propofol|
196575|NCT01387139|B1|Baseline|Ketamine Alone|
196576|NCT01387139|P2|Participant Flow|Ketamine Co-Administered With Propofol|Ketamine Co-administered with Propofol: 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
196577|NCT01387139|P1|Participant Flow|Ketamine Alone|Ketamine: 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)
196578|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
196579|NCT01387139|O1|Outcome|Ketamine Alone|
196580|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
196581|NCT01387139|O1|Outcome|Ketamine Alone|
196582|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
196583|NCT01387139|O1|Outcome|Ketamine Alone|
196584|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
196590|NCT01387139|E2|Reported Event|Ketamine Co-Administered With Propofol|
196591|NCT01387139|E1|Reported Event|Ketamine Alone|
196592|NCT01387074|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
196593|NCT01387074|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
196594|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
196595|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
196596|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
196597|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
196598|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
196599|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
196600|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
196601|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
196602|NCT01387074|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
196603|NCT01387022|B3|Baseline|Total|Total of all reporting groups
196604|NCT01387022|B2|Baseline|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
196605|NCT01387022|B1|Baseline|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
196606|NCT01387022|P2|Participant Flow|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
196607|NCT01387022|P1|Participant Flow|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
196608|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
196609|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
196610|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
196611|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
196612|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
196613|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
196614|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
196615|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
196616|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
196617|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
196618|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
196619|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
196620|NCT01387022|E2|Reported Event|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
196621|NCT01387022|E1|Reported Event|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
196622|NCT01386983|B3|Baseline|Total|Total of all reporting groups
196623|NCT01386983|B2|Baseline|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
196624|NCT01386983|B1|Baseline|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
196625|NCT01386983|P2|Participant Flow|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
196626|NCT01386983|P1|Participant Flow|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
196627|NCT01386983|O2|Outcome|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
196628|NCT01386983|O1|Outcome|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
196629|NCT01386983|O2|Outcome|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
196630|NCT01386983|O1|Outcome|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
196631|NCT01386983|E2|Reported Event|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
196632|NCT01386983|E1|Reported Event|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
196633|NCT01386944|B1|Baseline|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
196634|NCT01386944|P1|Participant Flow|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
196635|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
196636|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
196637|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
196638|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
196639|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
196640|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
196641|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
196642|NCT01386944|E1|Reported Event|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
196643|NCT01386788|B1|Baseline|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
196644|NCT01386788|P1|Participant Flow|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
196645|NCT01386788|O1|Outcome|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
196646|NCT01386788|O1|Outcome|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
196647|NCT01386788|E1|Reported Event|Smoke Inhalation Victim|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed
196648|NCT01386632|B3|Baseline|Total|Total of all reporting groups
196649|NCT01386632|B2|Baseline|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
196650|NCT01386632|B1|Baseline|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)
DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
196651|NCT01386632|P2|Participant Flow|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
196652|NCT01386632|P1|Participant Flow|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)
DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
196653|NCT01386632|O2|Outcome|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
196654|NCT01386632|O1|Outcome|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)
DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
196655|NCT01386632|O2|Outcome|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
196656|NCT01386632|O1|Outcome|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)
DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
196657|NCT01386632|E2|Reported Event|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
196658|NCT01386632|E1|Reported Event|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)
DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
196659|NCT01386606|B5|Baseline|Total|Total of all reporting groups
196660|NCT01386606|B4|Baseline|AndroGel|"AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks"
196661|NCT01386606|B3|Baseline|Androxal 25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196662|NCT01386606|B2|Baseline|Androxal 12.5 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196663|NCT01386606|B1|Baseline|Androxal 6.25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196664|NCT01386606|P4|Participant Flow|AndroGel|"AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks"
196665|NCT01386606|P3|Participant Flow|Androxal 25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196666|NCT01386606|P2|Participant Flow|Androxal 12.5 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196667|NCT01386606|P1|Participant Flow|Androxal 6.25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196668|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day
Androxal (enclomiphene citrate): capsule oral
1X a day 6 weeks"
196669|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day
Androxal (enclomiphene citrate): capsule oral
1X a day 6 weeks"
196670|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day
Androxal (enclomiphene citrate): capsule oral
1X a day 6 weeks"
196671|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day
Androxal (enclomiphene citrate): capsule oral
1X a day 6 weeks"
196672|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day
Androxal (enclomiphene citrate): capsule oral
1X a day 6 weeks"
196673|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day
Androxal (enclomiphene citrate): capsule oral
1X a day 6 weeks"
196674|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks"
196675|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196676|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196677|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196678|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day
Androxal (enclomiphene citrate): capsule oral
1X a day 6 weeks"
196679|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day
Androxal (enclomiphene citrate): capsule oral
1X a day 6 weeks"
196680|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day
Androxal (enclomiphene citrate): capsule oral
1X a day 6 weeks"
196681|NCT01386606|O1|Outcome|Androxal Pooled Dose Levels|Androxal 6.25, 12.5, and 25 mg subjects combined into a single group.
196682|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks"
196683|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196684|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196685|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196686|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks"
196687|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196688|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196689|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196690|NCT01386606|E4|Reported Event|AndroGel|"AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks"
196691|NCT01386606|E3|Reported Event|Androxal 25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196692|NCT01386606|E2|Reported Event|Androxal 12.5 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196693|NCT01386606|E1|Reported Event|Androxal 6.25 mg|"enclomiphene citrate: capsule oral
1X a day 6 weeks"
196694|NCT01386528|B1|Baseline|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
196695|NCT01386528|P1|Participant Flow|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
196696|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
196697|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
196719|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
196720|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
196721|NCT01386008|E1|Reported Event|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
196722|NCT01385995|B3|Baseline|Total|Total of all reporting groups
196698|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
196699|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
196700|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
196701|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
196702|NCT01386528|O1|Outcome|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
196703|NCT01386528|E1|Reported Event|Nonacog Beta Pegol|New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.
196704|NCT01386125|B3|Baseline|Total|Total of all reporting groups
196705|NCT01386125|B2|Baseline|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
196706|NCT01386125|B1|Baseline|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
196707|NCT01386125|P2|Participant Flow|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
196708|NCT01386125|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks
196709|NCT01386125|O2|Outcome|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
196710|NCT01386125|O1|Outcome|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
196711|NCT01386125|O2|Outcome|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
196712|NCT01386125|O1|Outcome|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
196713|NCT01386125|E2|Reported Event|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
196714|NCT01386125|E1|Reported Event|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
196715|NCT01386008|B1|Baseline|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
196716|NCT01386008|P1|Participant Flow|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
196717|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
196718|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
196725|NCT01385995|P2|Participant Flow|Sham-Continuous Positive Airway Pressure|
196726|NCT01385995|P1|Participant Flow|Continuous Positive Airway Pressure (CPAP)|
196727|NCT01385995|O2|Outcome|Sham CPAP|
196728|NCT01385995|O1|Outcome|Therapeutic CPAP|
196729|NCT01385995|O2|Outcome|Sham CPAP|
196730|NCT01385995|O1|Outcome|Therapeutic CPAP|
196731|NCT01385995|O2|Outcome|Sham CPAP|
196732|NCT01385995|O1|Outcome|Therapeutic CPAP|
196733|NCT01385995|O2|Outcome|Sham CPAP|
196734|NCT01385995|O1|Outcome|Therapeutic CPAP|
196735|NCT01385995|O2|Outcome|Sham CPAP|Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after sham CPAP therapy, in total sample, with the sham periods of both sequences combined.
196736|NCT01385995|O1|Outcome|Therapeutic CPAP|Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after therapeutic CPAP therapy, in total sample, with the active periods of both sequences combined.
196737|NCT01385995|E2|Reported Event|Sham-Continuous Positive Airway Pressure|
196738|NCT01385995|E1|Reported Event|Continuous Positive Airway Pressure (CPAP)|
196739|NCT01385748|B4|Baseline|Total|Total of all reporting groups
196740|NCT01385748|B3|Baseline|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets, once a day every day up to 8 weeks
196741|NCT01385748|B2|Baseline|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196742|NCT01385748|B1|Baseline|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196743|NCT01385748|P3|Participant Flow|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
196744|NCT01385748|P2|Participant Flow|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196745|NCT01385748|P1|Participant Flow|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196746|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
196747|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
196748|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196749|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196750|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
196751|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
196752|NCT01385748|O2|Outcome|Clonidine Lauriad® 100µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196753|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196754|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
196755|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
196756|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196757|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196758|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
196759|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
196760|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196761|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196762|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
196763|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
196764|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196765|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196766|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
196767|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
196768|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196769|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196770|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
196771|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
196772|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196773|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196774|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
196775|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196776|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196777|NCT01385748|O4|Outcome|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks.
196778|NCT01385748|O3|Outcome|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets once a day every day up to 8 weeks
196779|NCT01385748|O2|Outcome|Clonidine Lauriad® 100 µg|Clonidine Lauriad® 100 µg: 100 µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196780|NCT01385748|O1|Outcome|Clonidine Lauriad® 50 µg|Clonidine Lauriad® 50 µg: 50 µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196781|NCT01385748|E4|Reported Event|Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled|Pooled group of participants who received Clonidine Lauriad® 50 ug muco-adhesive buccal tablets or Clonidine Lauriad® 100 ug muco-adhesive buccal tablets once a day every day up to 8 weeks
196782|NCT01385748|E3|Reported Event|Placebo Lauriad®|Placebo Lauriad®: placebo muco-adhesive buccal tablets, once a day every day up to 8 weeks
196783|NCT01385748|E2|Reported Event|Clonidine Lauriad® 100µg|Clonidine Lauriad® 100µg: 100µg muco-adhesive buccal tablets once a day every day up to 8 weeks
196784|NCT01385748|E1|Reported Event|Clonidine Lauriad® 50µg|Clonidine Lauriad® 50µg: 50µg muco-adhesive buccal tablet once a day every day up to 8 weeks
196785|NCT01385696|B1|Baseline|Overall Study Safety Population|All patients randomized into the study excluding 1 patient who used Handihaler® once only, Genuair® zero times, & was excluded from the safety population
196786|NCT01385696|P2|Participant Flow|Placebo HandiHaler (Daily) Then Placebo Genuair (Daily)|Each morning, patients used the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo followed by the Genuair® (Almirall S.A.) inhaler containing placebo. The study period consisted of 1 period of 14 days.
196787|NCT01385696|P1|Participant Flow|Placebo Genuair (Daily) Then Placebo HandiHaler (Daily)|Each morning, patients used the Genuair® (Almirall S.A.) inhaler containing placebo followed by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo. The study period consisted of 1 period of 14 days.
196788|NCT01385696|O2|Outcome|Handihaler Inhaler|Intention-to-treat (ITT) population
196789|NCT01385696|O1|Outcome|Genuair Inhaler|Intention-to-treat (ITT) population
196790|NCT01385696|O2|Outcome|Handihaler Inhaler|Intention-to-treat (ITT) population
196791|NCT01385696|O1|Outcome|Genuair Inhaler|Intention-to-treat (ITT) population
196792|NCT01385696|O1|Outcome|Overall Intention-to-treat Population|Overall intention-to-treat (ITT) population
196793|NCT01385696|E2|Reported Event|HandiHaler Then Genuair|The study period consisted of 1 period of 14 days. Every morning patients used the HandiHaler® (Boehringer Ingelheim)inhaler containing placebo follow by the Genuair® (Almirall S.A.) inhaler containing placebo.
196794|NCT01385696|E1|Reported Event|Genuair Then HandiHaler|The study period consisted of 1 period of 14 days. Every morning patients used the Genuair® (Almirall S.A.) inhaler containing placebo follow by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo.
196795|NCT01385644|B3|Baseline|Total|Total of all reporting groups
196796|NCT01385644|B2|Baseline|2*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196797|NCT01385644|B1|Baseline|1*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196798|NCT01385644|P2|Participant Flow|2*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196799|NCT01385644|P1|Participant Flow|1*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196800|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196821|NCT01385566|B5|Baseline|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196801|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196802|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196803|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196804|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196805|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196806|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196807|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196808|NCT01385644|E2|Reported Event|2*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196809|NCT01385644|E1|Reported Event|1*10^6 MSC / kg|"Placental MSC
Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
196810|NCT01385579|B3|Baseline|Total|Total of all reporting groups
196811|NCT01385579|B2|Baseline|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
196812|NCT01385579|B1|Baseline|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
196813|NCT01385579|P2|Participant Flow|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
196814|NCT01385579|P1|Participant Flow|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
196815|NCT01385579|O2|Outcome|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
196816|NCT01385579|O1|Outcome|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
196817|NCT01385579|E2|Reported Event|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
196818|NCT01385579|E1|Reported Event|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
196819|NCT01385566|B7|Baseline|Total|Total of all reporting groups
196820|NCT01385566|B6|Baseline|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196822|NCT01385566|B4|Baseline|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196823|NCT01385566|B3|Baseline|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196824|NCT01385566|B2|Baseline|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196825|NCT01385566|B1|Baseline|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
196826|NCT01385566|P6|Participant Flow|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196827|NCT01385566|P5|Participant Flow|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196828|NCT01385566|P4|Participant Flow|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196829|NCT01385566|P3|Participant Flow|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196830|NCT01385566|P2|Participant Flow|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196831|NCT01385566|P1|Participant Flow|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
196832|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196833|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196834|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196835|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196836|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196837|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
196838|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196839|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196840|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196841|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196884|NCT01385371|B1|Baseline|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
196842|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196843|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
196844|NCT01385566|O7|Outcome|Placebo|On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
196845|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196846|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196847|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196848|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196849|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196850|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
196851|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196852|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196853|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196854|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196855|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196856|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
196857|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196858|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196859|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196860|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196861|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196885|NCT01385371|P2|Participant Flow|Placebo|Participants receiving Placebo
196862|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
196863|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196864|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196865|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196866|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196867|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196868|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
196869|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196870|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196871|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196872|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196873|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196874|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
196875|NCT01385566|E7|Reported Event|Placebo|On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Only injection-site adverse events occurring in the placebo limb are reported; systemic adverse events are reported by V211 treatment group only.
196876|NCT01385566|E6|Reported Event|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196877|NCT01385566|E5|Reported Event|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196878|NCT01385566|E4|Reported Event|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196879|NCT01385566|E3|Reported Event|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196880|NCT01385566|E2|Reported Event|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
196881|NCT01385566|E1|Reported Event|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
196882|NCT01385371|B3|Baseline|Total|Total of all reporting groups
196883|NCT01385371|B2|Baseline|Placebo|Participants receiving Placebo
196938|NCT01385189|O2|Outcome|10 µg Na-GST-1/Alhydrogel/GLA-AF (1 µg)|
196886|NCT01385371|P1|Participant Flow|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
196887|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
196888|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
196889|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
196890|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
196891|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
196892|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
196893|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
196894|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
196895|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
196896|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
196897|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
196898|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
196899|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
196900|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
196901|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
196902|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
196903|NCT01385371|E2|Reported Event|Placebo|Participants receiving Placebo
196904|NCT01385371|E1|Reported Event|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
196905|NCT01385293|B1|Baseline|BKM 120|BKM120 at 100mg orally daily
196906|NCT01385293|P1|Participant Flow|BKM 120|BKM120 at 100mg orally daily
196907|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
196908|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
196909|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
196910|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
196911|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
196912|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
196913|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
196914|NCT01385293|E1|Reported Event|BKM 120|BKM120 at 100mg orally daily
196915|NCT01385202|B1|Baseline|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
196916|NCT01385202|P1|Participant Flow|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
196917|NCT01385202|O2|Outcome|Calibration Roll-in|Calibration roll-in case(s) is intended to calibrate an investigator’s tactile feel, catheter manipulation technique, and use of other surrogate measures (electrogram signal, impedance, etc.) during the procedure.
196918|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter-Effective Cohort|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter.
196919|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
196920|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
196921|NCT01385202|E1|Reported Event|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
196922|NCT01385189|B6|Baseline|Total|Total of all reporting groups
196923|NCT01385189|B5|Baseline|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
196924|NCT01385189|B4|Baseline|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
196925|NCT01385189|B3|Baseline|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
196926|NCT01385189|B2|Baseline|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
196927|NCT01385189|B1|Baseline|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
196928|NCT01385189|P5|Participant Flow|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
196929|NCT01385189|P4|Participant Flow|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
196930|NCT01385189|P3|Participant Flow|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
196931|NCT01385189|P2|Participant Flow|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
196932|NCT01385189|P1|Participant Flow|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
196933|NCT01385189|O7|Outcome|100 µg Na-GST-1/Alhydrogel/GLA-AF (5 µg)|
196934|NCT01385189|O6|Outcome|100 µg Na-GST-1/Alhydrogel|
196935|NCT01385189|O5|Outcome|30 µg Na-GST-1/Alhydrogel/GLA-AF (5 µg)|
196936|NCT01385189|O4|Outcome|30 µg Na-GST-1/Alhydrogel/GLA-AF (1 µg)|
196937|NCT01385189|O3|Outcome|30 µg Na-GST-1/Alhydrogel|
196940|NCT01385189|O5|Outcome|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
196941|NCT01385189|O4|Outcome|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
196942|NCT01385189|O3|Outcome|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
196943|NCT01385189|O2|Outcome|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
196944|NCT01385189|O1|Outcome|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
196945|NCT01385189|E5|Reported Event|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
196946|NCT01385189|E4|Reported Event|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
196947|NCT01385189|E3|Reported Event|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
196948|NCT01385189|E2|Reported Event|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
196949|NCT01385189|E1|Reported Event|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
196950|NCT01385137|B3|Baseline|Total|Total of all reporting groups
196951|NCT01385137|B2|Baseline|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
196952|NCT01385137|B1|Baseline|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
196953|NCT01385137|P2|Participant Flow|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
196954|NCT01385137|P1|Participant Flow|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
196955|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
196956|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
196957|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
196958|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
196959|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
196960|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
196961|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
196962|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
196963|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
196964|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
196965|NCT01385137|E2|Reported Event|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
196966|NCT01385137|E1|Reported Event|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
196967|NCT01385033|B3|Baseline|Total|Total of all reporting groups
196968|NCT01385033|B2|Baseline|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
196969|NCT01385033|B1|Baseline|AD Participants|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
196970|NCT01385033|P6|Participant Flow|Amnestic Mild Cognitive Impairment Participants (Part III)|Participants with amnestic Mild Cognitive Impairment received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part III)
196971|NCT01385033|P5|Participant Flow|Healthy Young (HY) Participants (Part II)|HY participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
196972|NCT01385033|P4|Participant Flow|HE Participants (Part II)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
196973|NCT01385033|P3|Participant Flow|AD Participants (Part II)|AD participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by PET imaging of the brain (Part II)
197501|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
196974|NCT01385033|P2|Participant Flow|Healthy Elderly (HE) Participants (Part I)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part I)
196975|NCT01385033|P1|Participant Flow|Alzheimer's Disease (AD) Participants (Part I)|AD participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by positron emission tomography (PET) imaging of the brain (Part I)
196976|NCT01385033|O1|Outcome|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
196977|NCT01385033|O2|Outcome|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
196978|NCT01385033|O1|Outcome|AD Participants|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
196979|NCT01385033|O1|Outcome|AD and HE Participants|AD and HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
196980|NCT01385033|E1|Reported Event|All Study Participants|Participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
196981|NCT01384760|B3|Baseline|Total|Total of all reporting groups
196982|NCT01384760|B2|Baseline|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
196983|NCT01384760|B1|Baseline|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
196984|NCT01384760|P2|Participant Flow|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
196985|NCT01384760|P1|Participant Flow|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
196986|NCT01384760|O2|Outcome|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
196987|NCT01384760|O1|Outcome|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
196988|NCT01384760|O2|Outcome|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
196989|NCT01384760|O1|Outcome|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
196990|NCT01384760|E2|Reported Event|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
196991|NCT01384760|E1|Reported Event|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
196992|NCT01384539|B3|Baseline|Total|Total of all reporting groups
196993|NCT01384539|B2|Baseline|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Calcitriol"
196994|NCT01384539|B1|Baseline|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Cholecalciferol"
196995|NCT01384539|P2|Participant Flow|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Calcitriol"
196996|NCT01384539|P1|Participant Flow|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Cholecalciferol"
196997|NCT01384539|O2|Outcome|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Calcitriol"
196998|NCT01384539|O1|Outcome|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Cholecalciferol"
196999|NCT01384539|E2|Reported Event|Calcitriol|"Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Calcitriol"
197000|NCT01384539|E1|Reported Event|Cholecalciferol|"Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Cholecalciferol"
197001|NCT01384292|B4|Baseline|Total|Total of all reporting groups
197002|NCT01384292|B3|Baseline|Placebo|Placebo, oral treatment
197003|NCT01384292|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
197004|NCT01384292|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
197005|NCT01384292|P3|Participant Flow|Placebo|Placebo, oral treatment
197006|NCT01384292|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
197007|NCT01384292|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
197008|NCT01384292|O3|Outcome|Placebo|Placebo, oral treatment
197009|NCT01384292|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
197010|NCT01384292|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
197011|NCT01384292|E5|Reported Event|NKTR-118 25 mg - Part B|Part B NKTR-118 25 mg, oral treatment
197012|NCT01384292|E4|Reported Event|NKTR-118 12.5 mg - Part B|Part B NKTR-118 12.5 mg, oral treatment
197013|NCT01384292|E3|Reported Event|Placebo - Part A|Part A Placebo, oral treatment
197014|NCT01384292|E2|Reported Event|NKTR-118 25 mg - Part A|Part A NKTR-118 25 mg, oral treatment
197015|NCT01384292|E1|Reported Event|NKTR-118 12.5 mg - Part A|Part A NKTR-118 12.5 mg, oral treatment
197016|NCT01384019|B3|Baseline|Total|Total of all reporting groups
197017|NCT01384019|B2|Baseline|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
197018|NCT01384019|B1|Baseline|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
197019|NCT01384019|P2|Participant Flow|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
197020|NCT01384019|P1|Participant Flow|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
197021|NCT01384019|O2|Outcome|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
197022|NCT01384019|O1|Outcome|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
197023|NCT01384019|E2|Reported Event|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
197024|NCT01384019|E1|Reported Event|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
197025|NCT01383993|B4|Baseline|Total|Total of all reporting groups
197026|NCT01383993|B3|Baseline|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197027|NCT01383993|B2|Baseline|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197028|NCT01383993|B1|Baseline|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197029|NCT01383993|P3|Participant Flow|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197030|NCT01383993|P2|Participant Flow|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197140|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197031|NCT01383993|P1|Participant Flow|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197032|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197033|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197034|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197035|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197036|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197037|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197038|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197039|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197040|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197041|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197042|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197043|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197141|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197044|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197045|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197046|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197047|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197048|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197049|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197050|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197051|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197052|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197053|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197054|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197055|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197056|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197142|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197057|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197058|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197059|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197060|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197061|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197062|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197063|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197064|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197065|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197066|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197067|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197068|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197069|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197143|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197070|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197071|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197072|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197073|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197074|NCT01383993|E3|Reported Event|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197075|NCT01383993|E2|Reported Event|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197076|NCT01383993|E1|Reported Event|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
197077|NCT01383954|B1|Baseline|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
197078|NCT01383954|P1|Participant Flow|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
197079|NCT01383954|O1|Outcome|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
197080|NCT01383954|O1|Outcome|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
197081|NCT01383954|E1|Reported Event|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
197082|NCT01383928|B4|Baseline|Total|Total of all reporting groups
197083|NCT01383928|B3|Baseline|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197084|NCT01383928|B2|Baseline|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197085|NCT01383928|B1|Baseline|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197502|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
197086|NCT01383928|P3|Participant Flow|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197087|NCT01383928|P2|Participant Flow|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197088|NCT01383928|P1|Participant Flow|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197089|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197090|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197091|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197092|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197093|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197094|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197144|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197095|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197096|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197097|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197098|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197099|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197100|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197101|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197102|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197103|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197503|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
197104|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197105|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197106|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197107|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197108|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197109|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197110|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197111|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197112|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197145|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197146|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197147|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197504|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
197113|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving the same dose of ixazomib (MLN9708) capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197114|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197115|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197116|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197117|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197118|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197119|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197120|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197121|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197148|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197149|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197150|NCT01383720|E1|Reported Event|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197122|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197123|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197124|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197125|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197126|NCT01383928|E3|Reported Event|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197127|NCT01383928|E2|Reported Event|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197128|NCT01383928|E1|Reported Event|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
197129|NCT01383720|B1|Baseline|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197130|NCT01383720|P1|Participant Flow|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197131|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197132|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197133|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197134|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197135|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197136|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197137|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197138|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197139|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
197505|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
197151|NCT01383707|B1|Baseline|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
197152|NCT01383707|P1|Participant Flow|Bevacizumab + Modified FOLFOX-6 (mFOLFOX-6)|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
197153|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
197154|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
197155|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
197156|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
197157|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
197196|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197197|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197506|NCT01382719|E4|Reported Event|Bremelanotide Arm 3|high dose 1.75 mg BMT
197158|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
197159|NCT01383707|E1|Reported Event|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
197160|NCT01383681|B1|Baseline|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
197161|NCT01383681|P1|Participant Flow|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
197162|NCT01383681|O1|Outcome|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
197163|NCT01383681|O1|Outcome|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
197164|NCT01383681|E1|Reported Event|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
197165|NCT01383616|B3|Baseline|Total|Total of all reporting groups
197166|NCT01383616|B2|Baseline|Bipedicular Kyphoplasty Group|In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
197167|NCT01383616|B1|Baseline|Unipedicular Kyphoplasty|In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
197168|NCT01383616|P2|Participant Flow|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
197169|NCT01383616|P1|Participant Flow|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
197198|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197199|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197170|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
197171|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
197172|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.
A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
197173|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.
A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
197174|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.
A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
197175|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.
A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
197176|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.
A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
197177|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.
A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
197178|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.
A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
197179|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.
A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
197180|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.
A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
197181|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.
A guidewire was placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
197182|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
197183|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
197184|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
197200|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197201|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197202|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197203|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197185|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
197186|NCT01383616|O1|Outcome|Bipedicular Kyphoplasty Group|"Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered deliver bone cement.
A guidewire was placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden."
197187|NCT01383616|O2|Outcome|Bipedicular Kyphoplasty Group|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
197188|NCT01383616|O1|Outcome|Unipedicular Kyphoplasty|Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
197189|NCT01383616|E2|Reported Event|Bipedicular Kyphoplasty Group|Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
197190|NCT01383616|E1|Reported Event|Unipedicular Kyphoplasty|Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
197191|NCT01383499|B1|Baseline|Total.|Total number of patients randomised and treated at all in the study.
197192|NCT01383499|P4|Participant Flow|Tio R2.5/Tio R1.25/Placebo|Patients treated with Tiotropium 2.5 mcg in Period 1, with Tiotropium 1.25 mcg in Period 2 and with Placebo in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
197193|NCT01383499|P3|Participant Flow|Placebo/Tio R2.5/Tio R5|Patients treated with Placebo in Period 1, with Tiotropium 2.5 mcg in Period 2 and with Tiotropium 5 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
197194|NCT01383499|P2|Participant Flow|Tio R1.25/Tio R5/Tio R2.5|Patients treated with Tiotropium 1.25 mcg in Period 1, with Tiotropium 5 mcg in Period 2 and with Tiotropium 2.5 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
197195|NCT01383499|P1|Participant Flow|Tio R5/Placebo/Tio R1.25|Patients treated with Tiotropium 5 mcg in Period 1, with Placebo in Period 2 and with Tiotropium 1.25 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
197204|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197205|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197206|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197207|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197208|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197209|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197210|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197211|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197212|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197213|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197214|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197215|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197216|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197217|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197218|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197219|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197220|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197221|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197222|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197223|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197224|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197225|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197226|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197227|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197228|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197229|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197230|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197231|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197232|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197233|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197234|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197235|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197236|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197237|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197238|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197239|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197240|NCT01383499|E4|Reported Event|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197241|NCT01383499|E3|Reported Event|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197242|NCT01383499|E2|Reported Event|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197243|NCT01383499|E1|Reported Event|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
197244|NCT01383486|B1|Baseline|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
197245|NCT01383486|P1|Participant Flow|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
197246|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
197247|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
197248|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
197249|NCT01383486|E1|Reported Event|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
197250|NCT01383447|B1|Baseline|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
entinostat: Given PO
imatinib mesylate: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
western blotting: Correlative studies
immunohistochemistry staining method: Correlative studies
flow cytometry: Correlative studies
polymerase chain reaction: Correlative studies
high performance liquid chromatography: Correlative studies
mass spectrometry: Correlative studies"
197251|NCT01383447|P1|Participant Flow|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
entinostat: Given PO
imatinib mesylate: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
western blotting: Correlative studies
immunohistochemistry staining method: Correlative studies
flow cytometry: Correlative studies
polymerase chain reaction: Correlative studies
high performance liquid chromatography: Correlative studies
mass spectrometry: Correlative studies"
197252|NCT01383447|O1|Outcome|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
entinostat: Given PO
imatinib mesylate: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
western blotting: Correlative studies
immunohistochemistry staining method: Correlative studies
flow cytometry: Correlative studies
polymerase chain reaction: Correlative studies
high performance liquid chromatography: Correlative studies
mass spectrometry: Correlative studies"
197253|NCT01383447|O1|Outcome|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
entinostat: Given PO
imatinib mesylate: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
western blotting: Correlative studies
immunohistochemistry staining method: Correlative studies
flow cytometry: Correlative studies
polymerase chain reaction: Correlative studies
high performance liquid chromatography: Correlative studies
mass spectrometry: Correlative studies"
197271|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197401|NCT01383096|O5|Outcome|Cohort 1 - Treatement E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
197254|NCT01383447|O1|Outcome|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
entinostat: Given PO
imatinib mesylate: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
western blotting: Correlative studies
immunohistochemistry staining method: Correlative studies
flow cytometry: Correlative studies
polymerase chain reaction: Correlative studies
high performance liquid chromatography: Correlative studies
mass spectrometry: Correlative studies"
197255|NCT01383447|O1|Outcome|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
entinostat: Given PO
imatinib mesylate: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
western blotting: Correlative studies
immunohistochemistry staining method: Correlative studies
flow cytometry: Correlative studies
polymerase chain reaction: Correlative studies
high performance liquid chromatography: Correlative studies
mass spectrometry: Correlative studies"
197256|NCT01383447|O1|Outcome|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
entinostat: Given PO
imatinib mesylate: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
western blotting: Correlative studies
immunohistochemistry staining method: Correlative studies
flow cytometry: Correlative studies
polymerase chain reaction: Correlative studies
high performance liquid chromatography: Correlative studies
mass spectrometry: Correlative studies"
197257|NCT01383447|E1|Reported Event|Treatment (Entinostat and Imatinib Mesylate)|"Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
entinostat: Given PO
imatinib mesylate: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
western blotting: Correlative studies
immunohistochemistry staining method: Correlative studies
flow cytometry: Correlative studies
polymerase chain reaction: Correlative studies
high performance liquid chromatography: Correlative studies
mass spectrometry: Correlative studies"
197258|NCT01383421|B1|Baseline|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (without taking participation in the study into account), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated by ADA for their RA."
197259|NCT01383421|P1|Participant Flow|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated by ADA for their RA."
197260|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197261|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197262|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197263|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197264|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197265|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197266|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197267|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197268|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197269|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197270|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197351|NCT01383174|B2|Baseline|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197272|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197273|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197274|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA."
197275|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197276|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197277|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA."
197278|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197279|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197280|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA."
197281|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197282|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197283|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA."
197284|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197285|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197286|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA."
197287|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197288|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197289|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA."
197290|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197291|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197292|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA."
197293|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197294|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197295|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197296|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197297|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197298|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197299|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197300|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197301|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA."
197302|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197303|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197304|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA."
197305|NCT01383421|O3|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197306|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197307|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA."
197308|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197309|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197310|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197311|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197312|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197313|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197507|NCT01382719|E3|Reported Event|Bremelanotide Arm 2|middle dose 1.25 mg BMT
197314|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197315|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197316|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197317|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197318|NCT01383421|O2|Outcome|Participants With RA Receiving Adalimumab: PSP Non-User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered."
197319|NCT01383421|O1|Outcome|Participants With RA Receiving Adalimumab: PSP User|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered."
197320|NCT01383421|E1|Reported Event|Participants With RA Receiving Adalimumab|"Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA."
197321|NCT01383356|B1|Baseline|Entire Study Population|Total number of subjects randomised and treated in the study.
197322|NCT01383356|P2|Participant Flow|Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg|Single tablets Linagliptin 2.5mg plus Metformin 500mg followed by combination tablet Linagliptin/Metformin 2.5mg/500mg
197323|NCT01383356|P1|Participant Flow|Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg|Combination tablet Linagliptin (Lina) /Metformin (Met) 2.5mg/500mg followed by single tablets Linagliptin 2.5mg plus Metformin 500mg
197324|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
197325|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
197326|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
197327|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
197328|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
197329|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
197330|NCT01383356|E2|Reported Event|Lina 2.5mg Plus Met 500mg|Single tablets
197331|NCT01383356|E1|Reported Event|Lina/Met 2.5mg/500mg|Combination tablet
197332|NCT01383213|B3|Baseline|Total|Total of all reporting groups
197333|NCT01383213|B2|Baseline|Oxygen Therapy (Group B)|group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
197334|NCT01383213|B1|Baseline|CPAP (Group A)|group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
197335|NCT01383213|P2|Participant Flow|Oxygen Therapy (Group B)|group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
197336|NCT01383213|P1|Participant Flow|CPAP (Group A)|group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
197337|NCT01383213|O2|Outcome|Oxygen Therapy (Group B)|"group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation"
197338|NCT01383213|O1|Outcome|CPAP (Group A)|"group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation"
197339|NCT01383213|E2|Reported Event|Oxygen Therapy (Group B)|"group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation"
197340|NCT01383213|E1|Reported Event|CPAP (Group A)|"group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation"
197341|NCT01383200|B3|Baseline|Total|Total of all reporting groups
197342|NCT01383200|B2|Baseline|TetracaineLeft Eye /LidocaineRight Eye|0.5% tetracaine drops Left eye / 2% lidocaine gel Right eye
197343|NCT01383200|B1|Baseline|TetracaineRight Eye / LidocaineLeft Eye|0.5% tetracaine drops Right eye /2% lidocaine gel Left eye
197344|NCT01383200|P2|Participant Flow|Tetracaine Left Eye / Lidocaine Right Eye|"Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel
11 eyes received 20% lidocaine gel."
197345|NCT01383200|P1|Participant Flow|Tetracaine Right Eye / Lidocaine Left Eye|"Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel
11 eyes received 0.5% tetracaine drops."
197346|NCT01383200|O2|Outcome|Lidocaine|2% lidocaine gel
197347|NCT01383200|O1|Outcome|Tetracaine|0.5% tetracaine drops
197348|NCT01383200|E2|Reported Event|Tetracaine Left Eye / Lidocaine Right Eye|0.5% Tetracaine Left eye / 2% Lidocaine Right eye
197349|NCT01383200|E1|Reported Event|Tetracaine Right Eye / Lidocaine Left Eye|0.5% Tetracaine drops Right eye / 2% Lidocaine Left eye
197350|NCT01383174|B3|Baseline|Total|Total of all reporting groups
197352|NCT01383174|B1|Baseline|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197353|NCT01383174|P2|Participant Flow|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197354|NCT01383174|P1|Participant Flow|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197355|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197356|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197357|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197358|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197359|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197360|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197361|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197362|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197363|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197364|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197365|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197366|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197367|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197368|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197369|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197399|NCT01383096|O7|Outcome|Cohort 2 - Treatement G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
197400|NCT01383096|O6|Outcome|Cohort 2 - Treatement F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
197370|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197371|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197372|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197373|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197374|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197375|NCT01383174|E2|Reported Event|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
197376|NCT01383174|E1|Reported Event|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.
Peer Support Program:
Work with a trained counselor who is a breast cancer survivor
Meet 8 times in-person over the 8 week program with the counselor
Counselor helps participant develop a personalized support program to help her improve her quality of life
Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
197377|NCT01383096|B4|Baseline|Total|Total of all reporting groups
197378|NCT01383096|B3|Baseline|Cohort 3|Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
197379|NCT01383096|B2|Baseline|Cohort 2|Subjects received a single dose of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.
197380|NCT01383096|B1|Baseline|Cohort 1|Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.
197381|NCT01383096|P3|Participant Flow|Cohort 3|Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
197382|NCT01383096|P2|Participant Flow|Cohort 2|Subjects received a single of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.
197383|NCT01383096|P1|Participant Flow|Cohort 1|Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.
197384|NCT01383096|O11|Outcome|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
197385|NCT01383096|O10|Outcome|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
197386|NCT01383096|O9|Outcome|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
197387|NCT01383096|O8|Outcome|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
197388|NCT01383096|O7|Outcome|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
197389|NCT01383096|O6|Outcome|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
197390|NCT01383096|O5|Outcome|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
197391|NCT01383096|O4|Outcome|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
197392|NCT01383096|O3|Outcome|Cohort 1 - Treatment C: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
197393|NCT01383096|O2|Outcome|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
197394|NCT01383096|O1|Outcome|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
197395|NCT01383096|O11|Outcome|Cohort 3 - Treatement K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
197396|NCT01383096|O10|Outcome|Cohort 3 - Treatement J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
197397|NCT01383096|O9|Outcome|Cohort 2 - Treatement I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
197398|NCT01383096|O8|Outcome|Cohort 2 - Treatement H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
197402|NCT01383096|O4|Outcome|Cohort 1 - Treatement D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
197403|NCT01383096|O3|Outcome|Cohort 1 - Treatment C:OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
197404|NCT01383096|O2|Outcome|Cohort 1 - Treatement B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
197405|NCT01383096|O1|Outcome|Cohort 1 - Treatement A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
197406|NCT01383096|O11|Outcome|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
197407|NCT01383096|O10|Outcome|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
197408|NCT01383096|O9|Outcome|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
197409|NCT01383096|O8|Outcome|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
197410|NCT01383096|O7|Outcome|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
197411|NCT01383096|O6|Outcome|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted
197412|NCT01383096|O5|Outcome|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
197413|NCT01383096|O4|Outcome|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
197414|NCT01383096|O3|Outcome|Cohort 1 - Treatment:OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
197415|NCT01383096|O2|Outcome|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
197416|NCT01383096|O1|Outcome|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
197417|NCT01383096|E11|Reported Event|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
197418|NCT01383096|E10|Reported Event|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
197419|NCT01383096|E9|Reported Event|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
197420|NCT01383096|E8|Reported Event|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
197421|NCT01383096|E7|Reported Event|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
197422|NCT01383096|E6|Reported Event|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
197423|NCT01383096|E5|Reported Event|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
197424|NCT01383096|E4|Reported Event|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
197425|NCT01383096|E3|Reported Event|Cohort 1 - Treatment C: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
197426|NCT01383096|E2|Reported Event|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
197427|NCT01383096|E1|Reported Event|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
197428|NCT01383005|B3|Baseline|Total|Total of all reporting groups
197429|NCT01383005|B2|Baseline|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
197430|NCT01383005|B1|Baseline|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
197431|NCT01383005|P2|Participant Flow|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
197432|NCT01383005|P1|Participant Flow|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
197450|NCT01382940|B1|Baseline|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
197433|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
197434|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
197435|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
197436|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
197437|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
197438|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
197439|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
197440|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
197441|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
197442|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
197443|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
197444|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
197445|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
197446|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
197447|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
197448|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
197449|NCT01383005|E1|Reported Event|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
197498|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
197499|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
197451|NCT01382940|P1|Participant Flow|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
197452|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
197453|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
197454|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
197455|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
197456|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
197457|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
197458|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
197459|NCT01382940|E1|Reported Event|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
197460|NCT01382901|B3|Baseline|Total|Total of all reporting groups
197461|NCT01382901|B2|Baseline|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
197462|NCT01382901|B1|Baseline|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
197463|NCT01382901|P2|Participant Flow|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
197464|NCT01382901|P1|Participant Flow|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
197465|NCT01382901|O2|Outcome|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
197466|NCT01382901|O1|Outcome|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
197467|NCT01382901|E2|Reported Event|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
197468|NCT01382901|E1|Reported Event|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
197469|NCT01382719|B5|Baseline|Total|Total of all reporting groups
197470|NCT01382719|B4|Baseline|Bremelanotide Arm 3|high dose 1.75 mg BMT
197471|NCT01382719|B3|Baseline|Bremelanotide Arm 2|middle dose 1.25 mg BMT
197472|NCT01382719|B2|Baseline|Bremelanotide Arm 1|low dose 0.75 mg BMT
197473|NCT01382719|B1|Baseline|Placebo|identical formulation without active ingredient
197474|NCT01382719|P4|Participant Flow|Bremelanotide Arm 3|high dose 1.75 mg BMT
197475|NCT01382719|P3|Participant Flow|Bremelanotide Arm 2|middle dose 1.25 mg BMT
197476|NCT01382719|P2|Participant Flow|Bremelanotide Arm 1|low dose 0.75 mg BMT
197477|NCT01382719|P1|Participant Flow|Placebo|identical formulation without active ingredient
197478|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
197479|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
197480|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
197481|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
197482|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
197483|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
197484|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
197485|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
197486|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
197487|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
197488|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
197489|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
197490|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
197491|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
197492|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
197493|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
197494|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
197495|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
197496|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
197497|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
197508|NCT01382719|E2|Reported Event|Bremelanotide Arm 1|low dose 0.75 mg BMT
197509|NCT01382719|E1|Reported Event|Placebo|identical formulation without active ingredient
197510|NCT01382446|B3|Baseline|Total|Total of all reporting groups
197511|NCT01382446|B2|Baseline|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
197512|NCT01382446|B1|Baseline|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
197513|NCT01382446|P2|Participant Flow|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
197514|NCT01382446|P1|Participant Flow|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
197515|NCT01382446|O2|Outcome|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
197516|NCT01382446|O1|Outcome|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
197517|NCT01382446|E2|Reported Event|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
197518|NCT01382446|E1|Reported Event|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
197519|NCT01382303|B3|Baseline|Total|Total of all reporting groups
197520|NCT01382303|B2|Baseline|Placebo|"placebo tablet
Placebo: placebo tablet three times a day"
197521|NCT01382303|B1|Baseline|Pentoxifylline|"Pentoxifylline 400mg three times a day
Pentoxifylline: Pentoxifylline 400mg three times a day"
197522|NCT01382303|P2|Participant Flow|Placebo|"placebo tablet
Placebo: placebo tablet three times a day"
197523|NCT01382303|P1|Participant Flow|Pentoxifylline|"Pentoxifylline 400mg three times a day
Pentoxifylline: Pentoxifylline 400mg three times a day"
197524|NCT01382303|O2|Outcome|Placebo|"placebo tablet
Placebo: placebo tablet three times a day"
197525|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day
Pentoxifylline: Pentoxifylline 400mg three times a day"
197526|NCT01382303|O2|Outcome|Placebo|"placebo tablet
Placebo: placebo tablet three times a day"
197527|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day
Pentoxifylline: Pentoxifylline 400mg three times a day"
197528|NCT01382303|O2|Outcome|Placebo|"placebo tablet
Placebo: placebo tablet three times a day"
197529|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day
Pentoxifylline: Pentoxifylline 400mg three times a day"
197530|NCT01382303|O2|Outcome|Placebo|"placebo tablet
Placebo: placebo tablet three times a day"
197531|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day
Pentoxifylline: Pentoxifylline 400mg three times a day"
197532|NCT01382303|O2|Outcome|Placebo|"placebo tablet
Placebo: placebo tablet three times a day"
197533|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day
Pentoxifylline: Pentoxifylline 400mg three times a day"
197534|NCT01382303|O2|Outcome|Placebo|"placebo tablet
Placebo: placebo tablet three times a day"
197535|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day
Pentoxifylline: Pentoxifylline 400mg three times a day"
197536|NCT01382303|E2|Reported Event|Placebo|"placebo tablet
Placebo: placebo tablet three times a day"
197537|NCT01382303|E1|Reported Event|Pentoxifylline|"Pentoxifylline 400mg three times a day
Pentoxifylline: Pentoxifylline 400mg three times a day"
197538|NCT01382251|B3|Baseline|Total|Total of all reporting groups
197539|NCT01382251|B2|Baseline|Ambulatory Surgery Caregivers|Caregivers were recruited with the patients receiving surgery
197540|NCT01382251|B1|Baseline|Ambulatory Surgery Patients|Only patients with caregivers were recruited
197541|NCT01382251|P2|Participant Flow|Ambulatory Surgery Caregivers|
197542|NCT01382251|P1|Participant Flow|Ambulatory Surgery Patients|
197543|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
197544|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
197545|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
197546|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
197547|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
197548|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
197549|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
197550|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
197551|NCT01382251|E1|Reported Event|Ambulatory Surgery Patients|
197552|NCT01382225|B3|Baseline|Total|Total of all reporting groups
197553|NCT01382225|B2|Baseline|Vehicle|Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197554|NCT01382225|B1|Baseline|Sodium Hyaluronate|Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197555|NCT01382225|P2|Participant Flow|Vehicle|Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197556|NCT01382225|P1|Participant Flow|Sodium Hyaluronate|Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197557|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197558|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197559|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197560|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197561|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197562|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197563|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197564|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197565|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197566|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197567|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197568|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197569|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197570|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197571|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197572|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197573|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197574|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197575|NCT01382225|E2|Reported Event|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197576|NCT01382225|E1|Reported Event|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
197577|NCT01382212|B1|Baseline|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197578|NCT01382212|P1|Participant Flow|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197579|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197580|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197581|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197582|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197583|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197584|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197585|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197586|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197587|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197588|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197589|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197590|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197591|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197592|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197593|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197594|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197595|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197596|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197597|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197598|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197599|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197600|NCT01382212|E1|Reported Event|Paricalcitol|Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.
197601|NCT01382186|B3|Baseline|Total|Total of all reporting groups
197602|NCT01382186|B2|Baseline|Random Sampling|Veterans registered for My HealtheVet and opted-in to use Secure Messaging from the Tampa, FL and Boston, MA areas.
197603|NCT01382186|B1|Baseline|Purposive Sampling|Veterans registered for My HealtheVet and opted-in to use Secure Messaging from the Tampa, FL and Boston, MA areas.
197604|NCT01382186|P2|Participant Flow|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
197605|NCT01382186|P1|Participant Flow|Purposive Sampling|Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
197606|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
197607|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
197608|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
197609|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
197610|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
197611|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
197612|NCT01382186|O1|Outcome|Purposive Sampling|Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
197613|NCT01382186|O3|Outcome|Purposive Sampling: Not Able to Complete Task|Veterans in this arm were not able to complete the task.
197614|NCT01382186|O2|Outcome|Purposive Sampling: Able to Complete Task With Difficulty|Veterans in this arm were able to complete task with some difficulty.
197615|NCT01382186|O1|Outcome|Purposive Sampling: Able to Complete Task|Veterans in this arm were able to complete the task.
197616|NCT01382186|E2|Reported Event|Random Sampling|Serious and other [non-serious] adverse events were not collected/assessed.
197617|NCT01382186|E1|Reported Event|Purposive Sampling|Serious and other [non-serious] adverse events were not collected/assessed.
197618|NCT01382108|B3|Baseline|Total|Total of all reporting groups
197619|NCT01382108|B2|Baseline|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
197620|NCT01382108|B1|Baseline|Normal Participants|Participants without meibomian gland dysfunction
197621|NCT01382108|P2|Participant Flow|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
197622|NCT01382108|P1|Participant Flow|Normal Participants|Participants without Meibomian Gland Dysfunction
197623|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
197624|NCT01382108|O1|Outcome|Normal Participants|Participants without meibomian gland dysfunction
197625|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
197626|NCT01382108|O1|Outcome|Normal Participants|Participants without meibomian gland dysfunction
197627|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
197628|NCT01382108|O1|Outcome|Normal Participants|Participants without Meibomian Gland Dysfunction
197629|NCT01382108|E2|Reported Event|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
197630|NCT01382108|E1|Reported Event|Normal Participants|Participants without meibomian gland dysfunction
197631|NCT01381952|B1|Baseline|AlluraXper - ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
197632|NCT01381952|P1|Participant Flow|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
197633|NCT01381952|O1|Outcome|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
197634|NCT01381952|O1|Outcome|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
197635|NCT01381952|O2|Outcome|Allura Clarity|Angiogram with AlluraXper followed by angiogram with ClarityIQ
197636|NCT01381952|O1|Outcome|AlluraXper|Angiogram with AlluraXper followed by angiogram with ClarityIQ
197637|NCT01381952|E1|Reported Event|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
197638|NCT01381926|B3|Baseline|Total|Total of all reporting groups
197639|NCT01381926|B2|Baseline|Exenatide 1st Then Placebo|Study participants in period 1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second period of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
197640|NCT01381926|B1|Baseline|Placebo 1st Then Exenatide|Study participants in period1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second periods of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
197641|NCT01381926|P2|Participant Flow|Placebo 1st Then Exenatide|Study participants in periods1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second periods of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
197642|NCT01381926|P1|Participant Flow|Exenatide 1st Then Placebo|Study participants in period 1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second period of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
197736|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
197643|NCT01381926|O2|Outcome|Placebo 1st Then Exenatide|Study participants in phase1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
197644|NCT01381926|O1|Outcome|Exenatide 1st Then Placebo|Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
197645|NCT01381926|O2|Outcome|Placebo Then Exenatide|"Study participants in phase1 will receive the saline placebo, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month study participants will receive Exenatide 5mcg twice daily with meals. During the fifth month, study participants will receive exenatide 10mcg, subcutaneously twice daily before meals.
exenatide: exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period. Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively."
197646|NCT01381926|O1|Outcome|Exenatide Then Placebo|"Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mg and exenatide 10mg, respectively, subcutaneously twice daily before meals.
exenatide: exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period. Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively."
197647|NCT01381926|O2|Outcome|Placebo 1st Then Exenatide|Study participants in phase1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
197648|NCT01381926|O1|Outcome|Exenatide 1st Then Placebo|Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
197649|NCT01381926|E2|Reported Event|Placebo 1st Then Exenatide|Study participants in phase1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
197650|NCT01381926|E1|Reported Event|Exenatide 1st Then Placebo|Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
197651|NCT01381900|B4|Baseline|Total|Total of all reporting groups
197652|NCT01381900|B3|Baseline|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197653|NCT01381900|B2|Baseline|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197654|NCT01381900|B1|Baseline|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197655|NCT01381900|P3|Participant Flow|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197656|NCT01381900|P2|Participant Flow|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197657|NCT01381900|P1|Participant Flow|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197658|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197737|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
197659|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197660|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197661|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197662|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197663|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197664|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197665|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197666|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197667|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197668|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197669|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197670|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197671|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197672|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197673|NCT01381900|E3|Reported Event|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197674|NCT01381900|E2|Reported Event|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197675|NCT01381900|E1|Reported Event|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
197676|NCT01380782|B3|Baseline|Total|Total of all reporting groups
197677|NCT01380782|B2|Baseline|Arm B Bevacizumab-treated|Bevacizumab-treated participants
197678|NCT01380782|B1|Baseline|Arm A Bevacizumab-naive|Bevacizumab-naive participants
197679|NCT01380782|P4|Participant Flow|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
197680|NCT01380782|P3|Participant Flow|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
197681|NCT01380782|P2|Participant Flow|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
197682|NCT01380782|P1|Participant Flow|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
197683|NCT01380782|O2|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
197684|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
197685|NCT01380782|O1|Outcome|All Participants (Arm A and B)|
197686|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
197687|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
197688|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
197689|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
197690|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
197691|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
197692|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
197693|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
197694|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
197738|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197695|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
197696|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
197697|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
197698|NCT01380782|O1|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
197699|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
197700|NCT01380782|E2|Reported Event|Arm B|Bevacizumab-treated participants
197701|NCT01380782|E1|Reported Event|Arm A|Bevacizumab-naive participants
197702|NCT01380769|B3|Baseline|Total|Total of all reporting groups
197703|NCT01380769|B2|Baseline|BSC (Best Supportive Care) Alone|Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
197704|NCT01380769|B1|Baseline|CRLX101 + BSC (Best Supportive Care)|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
197705|NCT01380769|P2|Participant Flow|BSC (Best Supportive Care) Alone|Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
197706|NCT01380769|P1|Participant Flow|CRLX101 + BSC (Best Supportive Care)|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
197707|NCT01380769|O2|Outcome|Best Supportive Care|Best Supportive Care: best supportive care
197708|NCT01380769|O1|Outcome|CRLX101|CRLX101: CRLX101 is administered at 15mg/m2 IV every other week
197709|NCT01380769|O2|Outcome|Best Supportive Care|Best Supportive Care: best supportive care
197710|NCT01380769|O1|Outcome|CRLX101|CRLX101: CRLX101 is administered at 15mg/m2 IV every other week
197711|NCT01380769|E2|Reported Event|Best Supportive Care (BSC) Only|Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
197712|NCT01380769|E1|Reported Event|CRLX101+BSC|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
197713|NCT01380730|B9|Baseline|Total|Total of all reporting groups
197714|NCT01380730|B8|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197715|NCT01380730|B7|Baseline|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197716|NCT01380730|B6|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197717|NCT01380730|B5|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197718|NCT01380730|B4|Baseline|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197719|NCT01380730|B3|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197720|NCT01380730|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
197721|NCT01380730|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
197722|NCT01380730|P8|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197723|NCT01380730|P7|Participant Flow|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197724|NCT01380730|P6|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197725|NCT01380730|P5|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197726|NCT01380730|P4|Participant Flow|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197727|NCT01380730|P3|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197728|NCT01380730|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
197729|NCT01380730|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
197730|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197731|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197732|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197733|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197734|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197735|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197739|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197740|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197741|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197742|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197743|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197744|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
197745|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
197746|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197747|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197748|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197749|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197750|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197751|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197752|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
197753|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
197754|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197755|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197756|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197757|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197758|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197759|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197760|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
197761|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
197762|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197763|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197764|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197765|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197766|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197767|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197768|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
197769|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
197770|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197771|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197772|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197773|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197774|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197775|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197776|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
197777|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
197778|NCT01380730|E8|Reported Event|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197779|NCT01380730|E7|Reported Event|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197780|NCT01380730|E6|Reported Event|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
197781|NCT01380730|E5|Reported Event|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197782|NCT01380730|E4|Reported Event|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197783|NCT01380730|E3|Reported Event|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
197784|NCT01380730|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
197785|NCT01380730|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
197786|NCT01381679|B1|Baseline|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197787|NCT01381679|P1|Participant Flow|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197788|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197789|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197790|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197791|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197792|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197793|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197794|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197795|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197796|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197797|NCT01381679|E1|Reported Event|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
197798|NCT01381575|B4|Baseline|Total|Total of all reporting groups
197799|NCT01381575|B3|Baseline|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197800|NCT01381575|B2|Baseline|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197801|NCT01381575|B1|Baseline|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197802|NCT01381575|P3|Participant Flow|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197803|NCT01381575|P2|Participant Flow|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197804|NCT01381575|P1|Participant Flow|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197805|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197806|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197807|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197808|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197809|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197810|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197811|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197812|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197813|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197814|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197815|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197816|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197817|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197818|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197819|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197820|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197821|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197822|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197823|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197824|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197825|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197826|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197827|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197828|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197829|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197830|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197831|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197832|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197833|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197834|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197835|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197836|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197837|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197838|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197839|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197840|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197841|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197842|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197843|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197844|NCT01381575|O1|Outcome|Cervarix1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197845|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197846|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197847|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197848|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197849|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197850|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197851|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197852|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197853|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197854|NCT01381575|E3|Reported Event|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197855|NCT01381575|E2|Reported Event|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197856|NCT01381575|E1|Reported Event|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
197857|NCT01381471|B1|Baseline|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
197858|NCT01381471|P1|Participant Flow|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
197859|NCT01381471|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
197860|NCT01381471|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
197861|NCT01381471|E1|Reported Event|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
197862|NCT01381406|B3|Baseline|Total|Total of all reporting groups
197863|NCT01381406|B2|Baseline|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
197864|NCT01381406|B1|Baseline|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
197865|NCT01381406|P2|Participant Flow|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
197866|NCT01381406|P1|Participant Flow|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period
197867|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
197868|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
197869|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
197870|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
197871|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
197872|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
197873|NCT01381406|E2|Reported Event|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
197874|NCT01381406|E1|Reported Event|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
197875|NCT01381120|B3|Baseline|Total|Total of all reporting groups
197876|NCT01381120|B2|Baseline|Narcotic Painkiller|
197877|NCT01381120|B1|Baseline|VESIcare + Narcotic Painkiller|
197878|NCT01381120|P2|Participant Flow|Narcotic Painkiller|
197879|NCT01381120|P1|Participant Flow|VESIcare + Narcotic Painkiller|
197880|NCT01381120|O2|Outcome|Narcotic Painkiller|Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
197881|NCT01381120|O1|Outcome|VESIcare + Narcotic Painkiller|VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
197882|NCT01381120|O2|Outcome|Narcotic Painkiller|Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
197883|NCT01381120|O1|Outcome|VESIcare + Narcotic Painkiller|VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
197884|NCT01381120|E2|Reported Event|Narcotic Painkiller|
197885|NCT01381120|E1|Reported Event|VESIcare + Narcotic Painkiller|
197886|NCT01381016|B3|Baseline|Total|Total of all reporting groups
197887|NCT01381016|B2|Baseline|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)
Estradiol, Lutrelef or gonadorelin"
197888|NCT01381016|B1|Baseline|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)
Estradiol, Lutrelef or gonadorelin"
197889|NCT01381016|P2|Participant Flow|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)
Estradiol, Lutrelef or gonadorelin"
197890|NCT01381016|P1|Participant Flow|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)
Estradiol, Lutrelef or gonadorelin"
197891|NCT01381016|O2|Outcome|Experimental|"Group 2: Obese (BMI >30 kg/m2)
Estradiol, Lutrelef or gonadorelin"
197892|NCT01381016|O1|Outcome|Control|"Group 1: Normal weight (BMI 18-25 kg/m2)
Estradiol, Lutrelef or gonadorelin"
197893|NCT01381016|O2|Outcome|Group 2 - Obese|"Group 2: Obese (BMI >30 kg/m2)
Estradiol, Lutrelef or gonadorelin"
197894|NCT01381016|O1|Outcome|Group 1 - Normal Weight|"Group 1: Normal weight (BMI 18-25 kg/m2)
Estradiol, Lutrelef or gonadorelin"
197895|NCT01381016|E2|Reported Event|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)
Estradiol, Lutrelef or gonadorelin"
197896|NCT01381016|E1|Reported Event|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)
Estradiol, Lutrelef or gonadorelin"
197897|NCT01380834|B3|Baseline|Total|Total of all reporting groups
197898|NCT01380834|B2|Baseline|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
197899|NCT01380834|B1|Baseline|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
197900|NCT01380834|P2|Participant Flow|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
197901|NCT01380834|P1|Participant Flow|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
198326|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
197902|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
197903|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
197904|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
197905|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
197906|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
197907|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
197908|NCT01380834|E2|Reported Event|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
197909|NCT01380834|E1|Reported Event|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
197910|NCT01380639|B3|Baseline|Total|Total of all reporting groups
197911|NCT01380639|B2|Baseline|Rehabilitation Without Vibration Training|
197912|NCT01380639|B1|Baseline|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
197913|NCT01380639|P2|Participant Flow|Rehabilitation Without Vibration Training|
197914|NCT01380639|P1|Participant Flow|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
197915|NCT01380639|O2|Outcome|Rehabilitation Without Vibration Training|
197916|NCT01380639|O1|Outcome|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
197917|NCT01380639|E2|Reported Event|Rehabilitation Without Vibration Training|
197918|NCT01380639|E1|Reported Event|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
197919|NCT01380379|B1|Baseline|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.
Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
197920|NCT01380379|P1|Participant Flow|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.
Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
197921|NCT01380379|O1|Outcome|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.
Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
197922|NCT01380379|O1|Outcome|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.
Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
197956|NCT01380197|B1|Baseline|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis
Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
197923|NCT01380379|E1|Reported Event|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.
Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
197924|NCT01380366|B1|Baseline|Patients Consented to be Given rHGH|Patients given growth hormone (rHGH) for their short bowel syndrome.
197925|NCT01380366|P1|Participant Flow|Zorptive Subjects|Patients consent to rHGH and Intestinal Permeability in Intestinal Failure Study
197926|NCT01380366|O1|Outcome|Patient Decreased Liver Injury|Results that show decreased liver injury (ALT, AST, bilirubin, alkaline phosphate (ALK or ALP), GGT) will show Zorbtive administration enhanced intestinal permeability and enhanced liver function.
197927|NCT01380366|O1|Outcome|Patients Experiencing Decrease in Concentration of Sucralose|A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.
197928|NCT01380366|E1|Reported Event|Patients Consented to be Given rHGH|Patients given growth hormone (rHGH) for their short bowel syndrome.
197929|NCT01380327|B4|Baseline|Total|Total of all reporting groups
197930|NCT01380327|B3|Baseline|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
197931|NCT01380327|B2|Baseline|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
197932|NCT01380327|B1|Baseline|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
197933|NCT01380327|P3|Participant Flow|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
197934|NCT01380327|P2|Participant Flow|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
197935|NCT01380327|P1|Participant Flow|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
197936|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
197937|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
197938|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
197939|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
197940|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
198434|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
197941|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
197942|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
197943|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
197944|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
197945|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
197946|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
197947|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
197948|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
197949|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
197950|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
197951|NCT01380327|E3|Reported Event|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily or twice-daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
197952|NCT01380327|E2|Reported Event|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
197953|NCT01380327|E1|Reported Event|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) twice-daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
197954|NCT01380197|B3|Baseline|Total|Total of all reporting groups
197955|NCT01380197|B2|Baseline|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients
Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
197957|NCT01380197|P2|Participant Flow|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients
Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
197958|NCT01380197|P1|Participant Flow|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis
Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
197959|NCT01380197|O2|Outcome|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients
Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
197960|NCT01380197|O1|Outcome|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis
Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
197961|NCT01380197|O2|Outcome|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients
Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
197962|NCT01380197|O1|Outcome|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis
Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
197963|NCT01380197|E2|Reported Event|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients
Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
197964|NCT01380197|E1|Reported Event|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis
Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
197965|NCT01380145|B1|Baseline|All Enrolled Subjects|Includes all subjects enrolled in the study.
197966|NCT01380145|P1|Participant Flow|All Enrolled Subjects|Subjects received a total of 8 pre- and post-auto-SCT immunizations with recMAGE-A3 + AS15 administered intramuscularly at a dose of 300 µg recMAGE-A3, with no dose adjustments permitted. The first immunization was administered 6 to 15 week prior to auto-SCT, with subsequent immunizations administered on Days 10, 31, 52, 73, and 94 (± 3 days) and Days 180 and 270 (± 7 days) after auto-SCT.
197967|NCT01380145|O1|Outcome|Evaluable Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
197968|NCT01380145|O1|Outcome|Evaluable Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
197969|NCT01380145|O1|Outcome|Immunogenicity Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
197970|NCT01380145|O1|Outcome|Immunogenicity Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
197971|NCT01380145|O1|Outcome|Safety Analysis Set|Includes all subjects who received at least 1 immunization with study drug.
197972|NCT01380145|E1|Reported Event|Safety Analysis Set|Includes all subjects who received at least 1 immunization with study drug.
197973|NCT01380093|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
197974|NCT01380093|P9|Participant Flow|EMBEDA Then Placebo Then Morphine|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
197975|NCT01380093|P8|Participant Flow|Placebo Then Morphine Then EMBEDA|Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
197976|NCT01380093|P7|Participant Flow|Morphine Then EMBEDA Then Placebo|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
198004|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198005|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
197977|NCT01380093|P6|Participant Flow|Morphine Then Placebo Then EMBEDA|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
197978|NCT01380093|P5|Participant Flow|EMBEDA Then Morphine Then Placebo|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
197979|NCT01380093|P4|Participant Flow|Placebo Then EMBEDA Then Morphine|Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of EMBEDA extended release (ER) capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) controlled release (CR) tablet 120 mg orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
197980|NCT01380093|P3|Participant Flow|Placebo Then Morphine|Single dose of matching placebo solution orally on Day 1 followed by single dose of morphine sulfate 120 mg solution orally on Day 2. Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.
197981|NCT01380093|P2|Participant Flow|Morphine Then Placebo|Single dose of morphine sulfate 120 mg solution orally on Day 1 followed by single dose of matching placebo solution orally on Day 2. Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.
197982|NCT01380093|P1|Participant Flow|Naloxone|Naloxone hydrochloride 0.2 milligram (mg) intravenously (IV) followed by additional 0.6 mg naloxone hydrochloride IV, each dose followed by an assessment for signs of withdrawal. Participants in this group were assigned to either morphine then placebo or placebo then morphine in the drug discrimination phase of the study.
197983|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197984|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197985|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197986|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197987|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197988|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197989|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197990|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197991|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197992|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197993|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197994|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197995|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197996|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197997|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197998|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
197999|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198000|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198001|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198002|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198003|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198435|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198006|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198007|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198008|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198009|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198010|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198011|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198012|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198013|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198014|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198015|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198016|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198017|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198018|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198019|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198020|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198021|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198022|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198023|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198024|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198025|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198026|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198027|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198028|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198029|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198030|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198031|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198032|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198033|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198034|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198035|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198036|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198037|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198038|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198039|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198040|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198041|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198042|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198043|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198044|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198045|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198046|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198047|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198048|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198049|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198050|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198051|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198052|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198053|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198054|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198055|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198056|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198057|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198058|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198059|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198060|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198061|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198062|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198063|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198064|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198065|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198066|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198067|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198068|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198069|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198070|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198071|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198072|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198073|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198074|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198075|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198076|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198077|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198078|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198079|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198080|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198081|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198082|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198083|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198084|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198085|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198086|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198087|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198088|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198089|NCT01380093|O2|Outcome|EMBEDA|Single dose of EMBEDA solution containing 120 mg morphine sulfate / 4.8 mg naltrexone hydrochloride administered orally in either of the first to third intervention periods.
198090|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198091|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198092|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198093|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198094|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198095|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198096|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198097|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198098|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198099|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198100|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198101|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198102|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198103|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198104|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198105|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198106|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198107|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198108|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198109|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198110|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198111|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198112|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198113|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198114|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198115|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198116|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198117|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198118|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198119|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198120|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198121|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198122|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198123|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198124|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198125|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198126|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198127|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198128|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198129|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198130|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198131|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198132|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198133|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198134|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198135|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198136|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198137|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198138|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198139|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198140|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198141|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198142|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198143|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198144|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198145|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198146|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198147|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198148|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198149|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198150|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198151|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198152|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198153|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198154|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198155|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198156|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198157|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198158|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198159|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198160|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198161|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198162|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198163|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198164|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198165|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198166|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198167|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198168|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198169|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198170|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198171|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198172|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198173|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198174|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198175|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198176|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198177|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198178|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198179|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198180|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198181|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198182|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198183|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198184|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198185|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198186|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198187|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198188|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198189|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198190|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198191|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198192|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198193|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198194|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198195|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198196|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198197|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198198|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198199|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198200|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198201|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198202|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198203|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198204|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198205|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198206|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198207|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198208|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198209|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198210|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198211|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198212|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198213|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198214|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198215|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198216|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198217|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198218|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198219|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198220|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198221|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198222|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198223|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198224|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198225|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198226|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198227|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198228|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198229|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198230|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198231|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198232|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198233|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198234|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198235|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198236|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198237|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198238|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198239|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198240|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198241|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198242|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198243|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198244|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198245|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198246|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198247|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198248|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198249|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198250|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198251|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198252|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198253|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198254|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198255|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198256|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198257|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198258|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198259|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198260|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198261|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198262|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198263|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198264|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198265|NCT01380093|E6|Reported Event|Morphine (Treatment Phase)|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
198266|NCT01380093|E5|Reported Event|EMBEDA (Treatment Phase)|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
198267|NCT01380093|E4|Reported Event|Placebo (Treatment Phase)|Single dose of matching placebo solution orally in either of the first to third intervention periods.
198268|NCT01380093|E3|Reported Event|Morphine (Drug Discrimination Phase)|Single dose of morphine sulfate 120 mg solution orally on Day 1 or 2.
198269|NCT01380093|E2|Reported Event|Placebo (Drug Discrimination Phase)|Single dose of matching placebo solution orally on Day 1 or 2.
198270|NCT01380093|E1|Reported Event|Naloxone (Naloxone Challenge Phase)|Naloxone hydrochloride 0.2 mg IV followed by additional 0.6 mg naloxone hydrochloride IV, each dose followed by an assessment for signs of withdrawal.
198271|NCT01380080|B3|Baseline|Total|Total of all reporting groups
198272|NCT01380080|B2|Baseline|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
198299|NCT01379937|B1|Baseline|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198300|NCT01379937|P4|Participant Flow|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198273|NCT01380080|B1|Baseline|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
198274|NCT01380080|P2|Participant Flow|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
198275|NCT01380080|P1|Participant Flow|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
198276|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
198277|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
198278|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
198279|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
198280|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
198281|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
198282|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
198301|NCT01379937|P3|Participant Flow|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198508|NCT01379625|B1|Baseline|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198283|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
198284|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
198285|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
198286|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
198287|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
198288|NCT01380080|E2|Reported Event|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
198289|NCT01380080|E1|Reported Event|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
198290|NCT01379963|B1|Baseline|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
198291|NCT01379963|P1|Participant Flow|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
198292|NCT01379963|O1|Outcome|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
198293|NCT01379963|O1|Outcome|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
198294|NCT01379963|E1|Reported Event|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
198295|NCT01379937|B5|Baseline|Total|Total of all reporting groups
198296|NCT01379937|B4|Baseline|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198297|NCT01379937|B3|Baseline|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198298|NCT01379937|B2|Baseline|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198545|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
198302|NCT01379937|P2|Participant Flow|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198303|NCT01379937|P1|Participant Flow|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198304|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198305|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198306|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198307|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198308|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198309|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198310|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198311|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198312|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198313|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198314|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198315|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198316|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198317|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198318|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198319|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198320|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198321|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region
198322|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198323|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198324|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198325|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198546|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
198327|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198328|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198329|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198330|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198331|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198332|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198333|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198334|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198335|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198336|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198337|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198338|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198339|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198340|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198341|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198342|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region
198343|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198344|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198345|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198346|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198347|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198348|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198349|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198350|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198351|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198509|NCT01379625|P2|Participant Flow|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198352|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198353|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198354|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198355|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198356|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198357|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198358|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198359|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198360|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198361|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198362|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198363|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198364|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198365|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198366|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198367|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198368|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198369|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198370|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198371|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198372|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198373|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198374|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix/Havrix Jr Pooled Group|Pooled group of subjects who received no or 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198375|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 & 2 - Havrix/Havrix Jr Pooled Group|Pooled group of subjects who received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, no or 1 booster dose of vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 or 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198376|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198377|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198378|NCT01379937|E4|Reported Event|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198379|NCT01379937|E3|Reported Event|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198380|NCT01379937|E2|Reported Event|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198381|NCT01379937|E1|Reported Event|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
198382|NCT01379781|B3|Baseline|Total|Total of all reporting groups
198383|NCT01379781|B2|Baseline|Treatment As Usual|"Referred to Treatment in the Community.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
198384|NCT01379781|B1|Baseline|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
198385|NCT01379781|P2|Participant Flow|Treatment As Usual|"Referred to Treatment in the Community.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
198386|NCT01379781|P1|Participant Flow|Behavioral Intervention for Postpartum Depression|"Behavioral Intervention for Postpartum Depression delivered over 3 in-person sessions.
Behavioral Intervention for Postpartum Depression: We will select a sample of pregnant women at risk for Postpartum Depression, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
198387|NCT01379781|O2|Outcome|Treatment As Usual|"Referred to Treatment in the Community.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
198388|NCT01379781|O1|Outcome|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
198389|NCT01379781|E2|Reported Event|Treatment As Usual|Referred to Treatment in the Community.
198390|NCT01379781|E1|Reported Event|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
198391|NCT01379768|B4|Baseline|Total|Total of all reporting groups
198392|NCT01379768|B3|Baseline|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
198393|NCT01379768|B2|Baseline|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198394|NCT01379768|B1|Baseline|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198395|NCT01379768|P3|Participant Flow|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
198396|NCT01379768|P2|Participant Flow|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198397|NCT01379768|P1|Participant Flow|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198398|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
198399|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198400|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198401|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
198402|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198660|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
198403|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198404|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
198405|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198406|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198407|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
198408|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198409|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198410|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
198411|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198412|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198413|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
198414|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198415|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198416|NCT01379768|E3|Reported Event|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
198417|NCT01379768|E2|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198418|NCT01379768|E1|Reported Event|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
198419|NCT01379703|B1|Baseline|Total Study Population|HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.
198420|NCT01379703|P3|Participant Flow|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198421|NCT01379703|P2|Participant Flow|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198422|NCT01379703|P1|Participant Flow|Tablets and Capsules or Oral Solution|HIV-1 infected participants who received both tablet and capsule formulations or oral solution.
198423|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198424|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198425|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198426|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
198427|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198428|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198429|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198430|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
198431|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198432|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198433|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198436|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198437|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198438|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198439|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198440|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198441|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198442|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198443|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
198444|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
198445|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
198446|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198447|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198448|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198449|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198450|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198451|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198452|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198453|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198454|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198455|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198456|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198457|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198458|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198459|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198460|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198461|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
198462|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
198463|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
198464|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198465|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198466|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198467|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198468|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198469|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198470|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198471|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198543|NCT01379521|P2|Participant Flow|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
198472|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198473|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198474|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198475|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198476|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198477|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198478|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198479|NCT01379703|E3|Reported Event|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
198480|NCT01379703|E2|Reported Event|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
198481|NCT01379703|E1|Reported Event|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
198482|NCT01379664|B3|Baseline|Total|Total of all reporting groups
198483|NCT01379664|B2|Baseline|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery
Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198484|NCT01379664|B1|Baseline|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery
Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198485|NCT01379664|P2|Participant Flow|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery
Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198486|NCT01379664|P1|Participant Flow|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery
Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198487|NCT01379664|O2|Outcome|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery
Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198488|NCT01379664|O1|Outcome|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery
Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198489|NCT01379664|O2|Outcome|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery
Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198490|NCT01379664|O1|Outcome|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery
Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198491|NCT01379664|O2|Outcome|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery
Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198492|NCT01379664|O1|Outcome|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery
Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198493|NCT01379664|E2|Reported Event|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery
Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198494|NCT01379664|E1|Reported Event|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery
Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
198495|NCT01379651|B3|Baseline|Total|Total of all reporting groups
198496|NCT01379651|B2|Baseline|Control|controls were kept on an egg-free diet for 6 months
198497|NCT01379651|B1|Baseline|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
198498|NCT01379651|P2|Participant Flow|Control|controls were kept on an egg-free diet for 6 months
198499|NCT01379651|P1|Participant Flow|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
198500|NCT01379651|O2|Outcome|Control|controls were kept on an egg-free diet for 6 months
198501|NCT01379651|O1|Outcome|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
198502|NCT01379651|O2|Outcome|Control|controls were kept on an egg-free diet for 6 months
198503|NCT01379651|O1|Outcome|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
198504|NCT01379651|E2|Reported Event|Control|controls were kept on an egg-free diet for 6 months
198505|NCT01379651|E1|Reported Event|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
198506|NCT01379625|B3|Baseline|Total|Total of all reporting groups
198507|NCT01379625|B2|Baseline|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198544|NCT01379521|P1|Participant Flow|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
198510|NCT01379625|P1|Participant Flow|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198511|NCT01379625|O2|Outcome|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198512|NCT01379625|O1|Outcome|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198513|NCT01379625|O2|Outcome|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198514|NCT01379625|O1|Outcome|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198515|NCT01379625|O2|Outcome|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198516|NCT01379625|O1|Outcome|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198517|NCT01379625|E2|Reported Event|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198518|NCT01379625|E1|Reported Event|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT
Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
198519|NCT01379534|B3|Baseline|Total|Total of all reporting groups
198520|NCT01379534|B2|Baseline|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198521|NCT01379534|B1|Baseline|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198522|NCT01379534|P2|Participant Flow|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198523|NCT01379534|P1|Participant Flow|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198524|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198525|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198526|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198527|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198528|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198529|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198530|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198531|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198532|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198533|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198534|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198535|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198536|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198537|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198538|NCT01379534|E2|Reported Event|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198539|NCT01379534|E1|Reported Event|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
198540|NCT01379521|B3|Baseline|Total|Total of all reporting groups
198541|NCT01379521|B2|Baseline|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
198542|NCT01379521|B1|Baseline|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
198547|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
198548|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
198549|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
198550|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
198551|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
198552|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
198553|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
198554|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
198555|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
198556|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
198557|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
198558|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
198559|NCT01379521|E2|Reported Event|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
198560|NCT01379521|E1|Reported Event|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
198561|NCT01379183|B3|Baseline|Total|Total of all reporting groups
198562|NCT01379183|B2|Baseline|Placebo|Matching placebo i.v. suspension
198563|NCT01379183|B1|Baseline|Erythromycin|Erythromycin 200 mg i.v. suspension
198564|NCT01379183|P2|Participant Flow|Placebo|Matching placebo i.v. suspension
198565|NCT01379183|P1|Participant Flow|Erythromycin|Erythromycin 200 mg i.v. suspension
198566|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension
Placebo: 200 mg suspension"
198567|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension
Erythromycin: 200 mg suspension"
198568|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension
Placebo: 200 mg suspension"
198569|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension
Erythromycin: 200 mg suspension"
198570|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension
Placebo: 200 mg suspension"
198571|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension
Erythromycin: 200 mg suspension"
198572|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension
Placebo: 200 mg suspension"
198573|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension
Erythromycin: 200 mg suspension"
198574|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension
Placebo: 200 mg suspension"
198575|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension
Erythromycin: 200 mg suspension"
198576|NCT01379183|O2|Outcome|Placebo|Matching placebo i.v. suspension
198577|NCT01379183|O1|Outcome|Erythromycin|Erythromycin 200 mg i.v. suspension
198578|NCT01379183|E2|Reported Event|Placebo|Matching placebo i.v. suspension
198579|NCT01379183|E1|Reported Event|Erythromycin|Erythromycin 200 mg i.v. suspension
198580|NCT01378988|B3|Baseline|Total|Total of all reporting groups
198581|NCT01378988|B2|Baseline|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198582|NCT01378988|B1|Baseline|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198583|NCT01378988|P2|Participant Flow|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198584|NCT01378988|P1|Participant Flow|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198585|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198586|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198587|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198588|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198589|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198590|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198591|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198592|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198593|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198594|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198595|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198596|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198597|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198598|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198599|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198600|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198601|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198602|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198603|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198604|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198605|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198606|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198607|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
198608|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
198609|NCT01378988|E2|Reported Event|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance dose
198610|NCT01378988|E1|Reported Event|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance dose
198611|NCT01378975|B3|Baseline|Total|Total of all reporting groups
198612|NCT01378975|B2|Baseline|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198613|NCT01378975|B1|Baseline|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198614|NCT01378975|P2|Participant Flow|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198615|NCT01378975|P1|Participant Flow|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198616|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198617|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198618|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198619|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198620|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198621|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198661|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
198662|NCT01378520|E2|Reported Event|Inert Powder|Inert powder (in capsule taken orally)
198663|NCT01378520|E1|Reported Event|Ketoconazole|Ketoconazole(600 mg taken orally)
198664|NCT01378429|B3|Baseline|Total|Total of all reporting groups
198622|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198623|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198624|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198625|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198626|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198627|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198628|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198629|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198630|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198631|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198632|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198633|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198665|NCT01378429|B2|Baseline|Ciclesonide Nasal Aerosol (74 mcg)|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198634|NCT01378975|O1|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198635|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198636|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198637|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198638|NCT01378975|E2|Reported Event|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198639|NCT01378975|E1|Reported Event|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
198640|NCT01378962|B1|Baseline|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198641|NCT01378962|P1|Participant Flow|Erlotinib 150 mg|Erlotinib 150 milligrams (mg) tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198642|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198643|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198644|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198645|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198646|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198647|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198648|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198649|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198650|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198651|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198652|NCT01378962|E1|Reported Event|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
198653|NCT01378520|B1|Baseline|Entire Study Population|Includes groups randomized to receive Ketoconazole first and inert powder first.
198654|NCT01378520|P2|Participant Flow|First Inert Powder, Then Ketoconazole|Inert powder (in capsule taken orally) in first intervention period and Ketoconzaole (600 mg taken orally) in second intervention period.
198655|NCT01378520|P1|Participant Flow|First Ketoconazole, Then Inert Powder|Ketoconzaole (600 mg taken orally) in first intervention period and inert powder (in capsule taken orally) in second intervention period.
198656|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
198657|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
198658|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
198659|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
198848|NCT01377467|P2|Participant Flow|Control|No treatment
198666|NCT01378429|B1|Baseline|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
198667|NCT01378429|P2|Participant Flow|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol (74 mcg)
ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)"
198668|NCT01378429|P1|Participant Flow|Placebo|Placebo: Placebo
198669|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198670|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
198671|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
198672|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
198673|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198674|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
198675|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198676|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
198677|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198678|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198679|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198680|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198681|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198682|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198683|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
198684|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
198685|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198686|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
198687|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198688|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
198689|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198690|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
198691|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
198692|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
198693|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198694|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
198695|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
198696|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
198697|NCT01378429|E2|Reported Event|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol (74 mcg)
ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)"
198698|NCT01378429|E1|Reported Event|Placebo|Placebo: Placebo
198699|NCT01378416|B1|Baseline|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
198700|NCT01378416|P1|Participant Flow|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
198701|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
198702|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
198703|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
198704|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
198705|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
198706|NCT01378416|E1|Reported Event|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
198707|NCT01378325|B3|Baseline|Total|Total of all reporting groups
198708|NCT01378325|B2|Baseline|Phenylephrine|PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
198709|NCT01378325|B1|Baseline|Saline|Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
198710|NCT01378325|P2|Participant Flow|Saline|crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
199095|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
198711|NCT01378325|P1|Participant Flow|Phenylephrine|"PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline"
198712|NCT01378325|O2|Outcome|Saline|crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
198713|NCT01378325|O1|Outcome|Phenylephrine|"PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline"
198714|NCT01378325|E2|Reported Event|Phenylephrine|Phenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
198715|NCT01378325|E1|Reported Event|Saline|Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
198716|NCT01378221|B3|Baseline|Total|Total of all reporting groups
198717|NCT01378221|B2|Baseline|Group 2|cardiac surgery patients aged 75 years and over
198718|NCT01378221|B1|Baseline|Group 1|cardiac surgery patients age 65 years and less
198719|NCT01378221|P2|Participant Flow|Group 2|cardiac surgery patients aged 75 years and over
198720|NCT01378221|P1|Participant Flow|Group 1|cardiac surgery patients age 65 years and less
198721|NCT01378221|O2|Outcome|Group 2|cardiac surgery patients aged 75 years and over
198722|NCT01378221|O1|Outcome|Group 1|cardiac surgery patients age 65 years and less
198723|NCT01378221|E2|Reported Event|Group 2|cardiac surgery patients aged 75 years and over
198724|NCT01378221|E1|Reported Event|Group 1|cardiac surgery patients age 65 years and less
198725|NCT01378195|B3|Baseline|Total|Total of all reporting groups
198726|NCT01378195|B2|Baseline|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
198727|NCT01378195|B1|Baseline|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
198728|NCT01378195|P2|Participant Flow|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
198729|NCT01378195|P1|Participant Flow|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
198730|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
198731|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
198732|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
198733|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
198734|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
198735|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
198736|NCT01378195|E2|Reported Event|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
198737|NCT01378195|E1|Reported Event|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
198738|NCT01378117|B4|Baseline|Total|Total of all reporting groups
198739|NCT01378117|B3|Baseline|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
198740|NCT01378117|B2|Baseline|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
198741|NCT01378117|B1|Baseline|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
198742|NCT01378117|P3|Participant Flow|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
198743|NCT01378117|P2|Participant Flow|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
198744|NCT01378117|P1|Participant Flow|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
198745|NCT01378117|O3|Outcome|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
198746|NCT01378117|O2|Outcome|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
198747|NCT01378117|O1|Outcome|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
198748|NCT01378117|E3|Reported Event|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
198749|NCT01378117|E2|Reported Event|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
198750|NCT01378117|E1|Reported Event|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
198751|NCT01378104|B3|Baseline|Total|Total of all reporting groups
198752|NCT01378104|B2|Baseline|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
198753|NCT01378104|B1|Baseline|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.
peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.
In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
198935|NCT01377233|O2|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
198754|NCT01378104|P2|Participant Flow|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
198755|NCT01378104|P1|Participant Flow|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.
peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.
In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
198756|NCT01378104|O2|Outcome|The Patients With Unfavourable IL28B Genotype|These group patients show the IL28B rs12979860 CT or TT and rs8099917 TG or GG.
198757|NCT01378104|O1|Outcome|Favourable IL28B Genotype|These group patients show the IL28B rs12979860CC and rs8099917TT.
198758|NCT01378104|O2|Outcome|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
198759|NCT01378104|O1|Outcome|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.
peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.
In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
198760|NCT01378104|E2|Reported Event|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
198761|NCT01378104|E1|Reported Event|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.
peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.
In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
198762|NCT01378065|B1|Baseline|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198763|NCT01378065|P1|Participant Flow|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198764|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198765|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198766|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198767|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198768|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198769|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198770|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198771|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198772|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198773|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198774|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198775|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198776|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198777|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
199096|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
198778|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198779|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198780|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198781|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198782|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198783|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198784|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198785|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198786|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198787|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198788|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198789|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198790|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198791|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198792|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198793|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198794|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198795|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198796|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198797|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198798|NCT01378065|E1|Reported Event|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
198799|NCT01377636|B1|Baseline|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
198800|NCT01377636|P1|Participant Flow|Pre and Post Isoproterenol Infusion|Bispectral EEG (BIS) monitoring and neurological examinations were repeated throughout an isoproterenol infusion protocol (20 minutes maximum) to measure the changes in arousal and ability to follow commands under anesthesia
198801|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
198802|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
198803|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
198804|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.
Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
198805|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
198806|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
198936|NCT01377233|O1|Outcome|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
198807|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.
Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
198808|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.
Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
198809|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|BIS monitoring and neurological examinations were repeated throughout an isoproterenol infusion protocol (20 minutes maximum) to measure the changes in arousal and ability to follow commands under anesthesia
198810|NCT01377636|E1|Reported Event|Pre and Post Isoproterenol Infusion|In this study, serious adverse events were considered clinically significant adverse events. The well known isoproterenol effects on heart rate, rhythm, ST segments, and blood pressure were noted.
198811|NCT01377623|B3|Baseline|Total|Total of all reporting groups
198812|NCT01377623|B2|Baseline|Dexmedetomidine Group|Fifty six subjects (28 in each arm) will be enrolled. Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
198813|NCT01377623|B1|Baseline|Placebo Group|Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
198814|NCT01377623|P2|Participant Flow|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
198815|NCT01377623|P1|Participant Flow|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
198816|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
198817|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
198818|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
198819|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
198820|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
198821|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
198822|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
198823|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
198824|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
198825|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
198826|NCT01377623|E2|Reported Event|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
198827|NCT01377623|E1|Reported Event|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
198828|NCT01377480|B5|Baseline|Total|Total of all reporting groups
198829|NCT01377480|B4|Baseline|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
198830|NCT01377480|B3|Baseline|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
198831|NCT01377480|B2|Baseline|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
198832|NCT01377480|B1|Baseline|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
198833|NCT01377480|P4|Participant Flow|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
198834|NCT01377480|P3|Participant Flow|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
198835|NCT01377480|P2|Participant Flow|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
198836|NCT01377480|P1|Participant Flow|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
198837|NCT01377480|O4|Outcome|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
198838|NCT01377480|O3|Outcome|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
198839|NCT01377480|O2|Outcome|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
198840|NCT01377480|O1|Outcome|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
198841|NCT01377480|E4|Reported Event|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
198842|NCT01377480|E3|Reported Event|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
198843|NCT01377480|E2|Reported Event|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
198844|NCT01377480|E1|Reported Event|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
198845|NCT01377467|B3|Baseline|Total|Total of all reporting groups
198846|NCT01377467|B2|Baseline|Control|No treatment
198847|NCT01377467|B1|Baseline|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198849|NCT01377467|P1|Participant Flow|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198850|NCT01377467|O2|Outcome|Control|No treatment
198851|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198852|NCT01377467|O2|Outcome|Control|No treatment
198853|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198854|NCT01377467|O2|Outcome|Control|No treatment
198855|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198856|NCT01377467|O2|Outcome|Control|No treatment
198857|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198858|NCT01377467|O2|Outcome|Control|No treatment
198859|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198860|NCT01377467|O2|Outcome|Control|No treatment
198861|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198862|NCT01377467|O2|Outcome|Control|No treatment
198863|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198864|NCT01377467|O2|Outcome|Control|No treatment
198865|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198866|NCT01377467|O2|Outcome|Control|No treatment
198867|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198868|NCT01377467|O2|Outcome|Control|No treatment
198869|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198870|NCT01377467|O2|Outcome|Control|No treatment
198871|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198872|NCT01377467|O2|Outcome|Control|No treatment
198873|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198874|NCT01377467|O2|Outcome|Control|No treatment
198875|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198876|NCT01377467|O2|Outcome|Control|No treatment
198877|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198878|NCT01377467|O2|Outcome|Control|No treatment
198879|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198880|NCT01377467|O2|Outcome|Control|No treatment
198881|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198882|NCT01377467|O2|Outcome|Control|No treatment
198883|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198884|NCT01377467|O2|Outcome|Control|No treatment
198885|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198886|NCT01377467|O2|Outcome|Control|No treatment
198887|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198888|NCT01377467|O2|Outcome|Control|No treatment
198889|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198890|NCT01377467|O2|Outcome|Control|No treatment
198891|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198892|NCT01377467|E2|Reported Event|Control|No treatment
198893|NCT01377467|E1|Reported Event|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
198894|NCT01377441|B3|Baseline|Total|Total of all reporting groups
198895|NCT01377441|B2|Baseline|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo
Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
198896|NCT01377441|B1|Baseline|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.
Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.
Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
198897|NCT01377441|P2|Participant Flow|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo
Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
198898|NCT01377441|P1|Participant Flow|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.
Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.
Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
198937|NCT01377233|E5|Reported Event|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198899|NCT01377441|O2|Outcome|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo
Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
198900|NCT01377441|O1|Outcome|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.
Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.
Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
198901|NCT01377441|E2|Reported Event|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo
Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
198902|NCT01377441|E1|Reported Event|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.
Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.
Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
198903|NCT01377402|B1|Baseline|Patients With Suspected Acute Coronary Chest Pain|Patients recruited immediately following acute hospital admission for suspected coronary chest pain.
198904|NCT01377402|P1|Participant Flow|Patients With Suspected Acute Coronary Chest Pain|Men and women admitted with chest pain and suspected acute coronary syndrome (ACS).
198905|NCT01377402|O2|Outcome|Myocardial Re-infarction|Patients with one or more myocardial re-infarctions during the course of the study
198906|NCT01377402|O1|Outcome|Cardiovascular Death|Patients with confirmed cardiovascular death during the course of the study
198907|NCT01377402|O1|Outcome|Patients With Suspected ACS|Patients with acute hospitalisation due to suspected coronary chest pain.
198908|NCT01377402|E1|Reported Event|Patients With Suspected ACS|Patients admitted to hospital with acute chest pain.
198909|NCT01377233|B6|Baseline|Total|Total of all reporting groups
198910|NCT01377233|B5|Baseline|Zicronapine 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198911|NCT01377233|B4|Baseline|Zicronapine 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198912|NCT01377233|B3|Baseline|Zicronapine 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198913|NCT01377233|B2|Baseline|Zicronapine 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
198914|NCT01377233|B1|Baseline|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
198915|NCT01377233|P5|Participant Flow|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198916|NCT01377233|P4|Participant Flow|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198917|NCT01377233|P3|Participant Flow|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198918|NCT01377233|P2|Participant Flow|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
198919|NCT01377233|P1|Participant Flow|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
198920|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198921|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198922|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198923|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
198924|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198925|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198926|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198927|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
198928|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198929|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198930|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198931|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
198932|NCT01377233|O5|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198933|NCT01377233|O4|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198934|NCT01377233|O3|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
199084|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
198938|NCT01377233|E4|Reported Event|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198939|NCT01377233|E3|Reported Event|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
198940|NCT01377233|E2|Reported Event|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
198941|NCT01377233|E1|Reported Event|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
198942|NCT01377194|B4|Baseline|Total|Total of all reporting groups
198943|NCT01377194|B3|Baseline|Levomilnacipran 80 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
198944|NCT01377194|B2|Baseline|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
198945|NCT01377194|B1|Baseline|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
198946|NCT01377194|P3|Participant Flow|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
198947|NCT01377194|P2|Participant Flow|Levomilnacipran ER 40 mg|40mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
198948|NCT01377194|P1|Participant Flow|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
198949|NCT01377194|O3|Outcome|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
198950|NCT01377194|O2|Outcome|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
198951|NCT01377194|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
198952|NCT01377194|O3|Outcome|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER oral administration in capsule form, once daily for 8 weeks
198953|NCT01377194|O2|Outcome|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER oral administration in capsule form, once daily, for 8 weeks.
198954|NCT01377194|O1|Outcome|Placebo|Dose matched placebo oral administration in capsule form, once daily, for 8 weeks.
198955|NCT01377194|E3|Reported Event|Levomilnacipran 80 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
198956|NCT01377194|E2|Reported Event|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
198957|NCT01377194|E1|Reported Event|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
198958|NCT01377012|B4|Baseline|Total|Total of all reporting groups
198959|NCT01377012|B3|Baseline|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198960|NCT01377012|B2|Baseline|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
198961|NCT01377012|B1|Baseline|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
198962|NCT01377012|P3|Participant Flow|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198963|NCT01377012|P2|Participant Flow|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
198964|NCT01377012|P1|Participant Flow|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks up to Week 100, then AIN457 150 mg s.c. starting at week 104
198965|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198966|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
198967|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
198968|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198969|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
198970|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
198971|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198972|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
198973|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
198974|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198975|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
199085|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
198976|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
198977|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198978|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
198979|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
198980|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198981|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
198982|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
198983|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198984|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
198985|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
198986|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198987|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
198988|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
198989|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198990|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
198991|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
198992|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
198993|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
198994|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
198995|NCT01377012|E3|Reported Event|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16 of core. Responders were switched to active treatment in week 24 of core
198996|NCT01377012|E2|Reported Event|Any AIN457 150 mg|Group contains all patients from the core and the extension that ever received AIN 150mg. This includes : participants who were randomized to AIN457 150 mg arm to receive AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 150 mg at week 16 or week 24 + participants who completed core study in any arm and continued in the extension study to receive AIN457 150 mg as open-label study drug
198997|NCT01377012|E1|Reported Event|Any AIN457 75 mg|Group contains all patients who received AIN 75mg during core period of the study. Includes : participants who were randomized to receive AIN457 i.v (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 75 mg at week 16 or week 24 of core study
198998|NCT01376908|B3|Baseline|Total|Total of all reporting groups
198999|NCT01376908|B2|Baseline|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199000|NCT01376908|B1|Baseline|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199001|NCT01376908|P2|Participant Flow|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199002|NCT01376908|P1|Participant Flow|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199086|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
199087|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
199003|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199004|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199005|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199006|NCT01376908|O3|Outcome|Population PK Analysis Set: Age Group 2 (>= 2 Years)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199007|NCT01376908|O2|Outcome|Population PK Analysis Set: Age Group 2 (1 to 2 Years)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199008|NCT01376908|O1|Outcome|Population PK Analysis Set: Age Group 1 (< 1 Year)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199009|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199010|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199011|NCT01376908|O1|Outcome|Pharmacogenetic Evaluation|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199012|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199013|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199014|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria. After 26 weeks, the starting dose of Kuvan will be 10 mg/kg/day, and the dose may be adjusted by the Investigator, if clinically indicated, but it may not exceed 20 mg/kg/day.
199088|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
199015|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.After 26 weeks, the dose may be adjusted by the Investigator, if clinically indicated, but it may not exceed 20 mg/kg/day.
199016|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199017|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199018|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199019|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199020|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199021|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199022|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199023|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199024|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199025|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199026|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199027|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199028|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199029|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199030|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199031|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199032|NCT01376908|E2|Reported Event|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199033|NCT01376908|E1|Reported Event|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
199034|NCT01376804|B1|Baseline|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
199089|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
199090|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
199035|NCT01376804|P1|Participant Flow|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose [in milligrams (mg)] was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
199036|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
199037|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
199038|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
199039|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
199040|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
199041|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
199042|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
199043|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
199044|NCT01376804|E1|Reported Event|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
199045|NCT01376700|B1|Baseline|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
199046|NCT01376700|P1|Participant Flow|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
199047|NCT01376700|O2|Outcome|MTPs|≤4 previous FVIII exposures
199048|NCT01376700|O1|Outcome|PUPs|No previous FVIII exposure
199049|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
199050|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
199051|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
199052|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
199053|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
199091|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
199092|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
199093|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
199094|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
199054|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
199055|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
199056|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
199057|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
199058|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
199059|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
199060|NCT01376700|E1|Reported Event|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
199061|NCT01376557|B6|Baseline|Total|Total of all reporting groups
199062|NCT01376557|B5|Baseline|Placebo qd|Placebo: Subjects will receive placebo once daily.
199063|NCT01376557|B4|Baseline|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
199064|NCT01376557|B3|Baseline|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
199065|NCT01376557|B2|Baseline|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
199066|NCT01376557|B1|Baseline|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
199067|NCT01376557|P5|Participant Flow|Placebo qd|Placebo: Subjects will receive placebo once daily.
199068|NCT01376557|P4|Participant Flow|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
199069|NCT01376557|P3|Participant Flow|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
199070|NCT01376557|P2|Participant Flow|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
199071|NCT01376557|P1|Participant Flow|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
199072|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
199073|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
199074|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
199075|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
199076|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
199077|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
199078|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
199079|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
199080|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
199081|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
199082|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
199083|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
199097|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
199098|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
199099|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
199100|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
199101|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
199102|NCT01376557|E5|Reported Event|Placebo qd|Placebo: Subjects will receive placebo once daily.
199103|NCT01376557|E4|Reported Event|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
199104|NCT01376557|E3|Reported Event|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
199105|NCT01376557|E2|Reported Event|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
199106|NCT01376557|E1|Reported Event|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
199107|NCT01376388|B1|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199108|NCT01376388|P1|Participant Flow|UMEC/VI 125/25 µg|Participants received GSK573719/GW642444 (UMEC/VI) 125/25 micrograms (µg) inhalation powder via a dry powder inhaler (DPI) once daily (OD) in the morning for 52 weeks.
199109|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199110|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199111|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199112|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199113|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199114|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199115|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199116|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199117|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199118|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199119|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199120|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
199121|NCT01376388|E1|Reported Event|GSK573719/GW642444|125/25mcg
199122|NCT01376362|B1|Baseline|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199123|NCT01376362|P1|Participant Flow|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199124|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199125|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199126|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199127|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199128|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199129|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199207|NCT01376050|O2|Outcome|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
199130|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199131|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199132|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199133|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199134|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199135|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199136|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199137|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199138|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199139|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199140|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199141|NCT01376362|E1|Reported Event|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
199142|NCT01376349|B4|Baseline|Total|Total of all reporting groups
199143|NCT01376349|B3|Baseline|Arm III Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. >
> There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
199144|NCT01376349|B2|Baseline|Arm II High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
199145|NCT01376349|B1|Baseline|Arm I Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
199146|NCT01376349|P3|Participant Flow|Arm III Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.
There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
199147|NCT01376349|P2|Participant Flow|Arm II High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
199229|NCT01375777|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
200609|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
199148|NCT01376349|P1|Participant Flow|Arm I Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
199149|NCT01376349|O3|Outcome|Arm III Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.
There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
199150|NCT01376349|O2|Outcome|Arm II High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
199151|NCT01376349|O1|Outcome|Arm I Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
199152|NCT01376349|E4|Reported Event|Optional Continuation Phase|"Patients randomized to Arm III Placebo who have completed protocol treatment for 12 weeks were offered the option of continuing treatment according to Arm II High Dose DHEA until unacceptable adverse events or patient refusal to continue participation on the study.
94 of the 147 patients randomized to the Placebo arm opted to continue treatment with High Dose DHEA."
199153|NCT01376349|E3|Reported Event|Arm III: Placebo|"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.
There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study."
199154|NCT01376349|E2|Reported Event|Arm II: High Dose DHEA|Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
199155|NCT01376349|E1|Reported Event|Arm I: Low Dose DHEA|Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
199156|NCT01376297|B3|Baseline|Total|Total of all reporting groups
199157|NCT01376297|B2|Baseline|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.
Aprepitant
Palonosetron
Dexamethasone"
199158|NCT01376297|B1|Baseline|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle
Netupitant and Palonosetron
Dexamethasone"
199159|NCT01376297|P2|Participant Flow|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.
Aprepitant
Palonosetron
Dexamethasone"
199160|NCT01376297|P1|Participant Flow|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle
Netupitant and Palonosetron
Dexamethasone"
199161|NCT01376297|O2|Outcome|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.
Aprepitant
Palonosetron
Dexamethasone"
199162|NCT01376297|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle
Netupitant and Palonosetron
Dexamethasone"
199163|NCT01376297|E2|Reported Event|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.
Aprepitant
Palonosetron
Dexamethasone"
199164|NCT01376297|E1|Reported Event|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle
Netupitant and Palonosetron
Dexamethasone"
199165|NCT01376245|B5|Baseline|Total|Total of all reporting groups
199166|NCT01376245|B4|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199167|NCT01376245|B3|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199168|NCT01376245|B2|Baseline|FF /VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199169|NCT01376245|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
199170|NCT01376245|P5|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199171|NCT01376245|P4|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199172|NCT01376245|P3|Participant Flow|FF /VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199230|NCT01375777|P9|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199173|NCT01376245|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
199174|NCT01376245|P1|Participant Flow|Placebo- Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
199175|NCT01376245|O4|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199176|NCT01376245|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199177|NCT01376245|O2|Outcome|FF/VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199178|NCT01376245|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
199179|NCT01376245|O4|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199180|NCT01376245|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199181|NCT01376245|O2|Outcome|FF/VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199182|NCT01376245|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
199183|NCT01376245|E4|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199184|NCT01376245|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199185|NCT01376245|E2|Reported Event|FF/VI 50/25 µg OD|articipants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
199186|NCT01376245|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
199187|NCT01376089|B3|Baseline|Total|Total of all reporting groups
199188|NCT01376089|B2|Baseline|Arm 2-Iopamidol|
199189|NCT01376089|B1|Baseline|Arm 1-Iodixanol|
199190|NCT01376089|P2|Participant Flow|Arm 2-Iopamidol|Subjects were injected with Iopamidol (Isovue).
199191|NCT01376089|P1|Participant Flow|Arm 1-Iodixanol|Subjects were injected with Iodixanol (Visipaque).
199192|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subject injected with Isovue 370mgI/mL contrast media.
199193|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media.
199194|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subjects injected with Isovue 370mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.
199195|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.
199196|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue)|Subjects injected with Isovue contrast media. Number of subjects with any Moderate / Severe discomfort.
199197|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque)|Subjects injected with Visipaque contrast media. Number of subjects with any Moderate / Severe discomfort.
199198|NCT01376089|E2|Reported Event|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subject injected with Isovue 370mgI/mL contrast media.
199199|NCT01376089|E1|Reported Event|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media.
199200|NCT01376050|B3|Baseline|Total|Total of all reporting groups
199201|NCT01376050|B2|Baseline|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
199202|NCT01376050|B1|Baseline|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
199203|NCT01376050|P2|Participant Flow|Placebo Laser|Placebo Laser has the same appearance and function as the Erchonia MLS but not does emit any therapeutic output.
199204|NCT01376050|P1|Participant Flow|Erchonia ML Scanner (MLS)|Erchonia ML Scanner (MLS) comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light-emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
199205|NCT01376050|O2|Outcome|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
199206|NCT01376050|O1|Outcome|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
199208|NCT01376050|O1|Outcome|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
199209|NCT01376050|E2|Reported Event|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
199210|NCT01376050|E1|Reported Event|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
199211|NCT01376037|B3|Baseline|Total|Total of all reporting groups
199212|NCT01376037|B2|Baseline|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.
inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
199213|NCT01376037|B1|Baseline|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.
Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
199214|NCT01376037|P2|Participant Flow|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.
inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
199215|NCT01376037|P1|Participant Flow|Erchonia ML Scanner (MLS)|The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17 milliWatts (mW) 635nm red laser light. The diodes are mounted in scanner devices positioned 120 degrees tileted from each other at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.
199216|NCT01376037|O2|Outcome|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.
inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
199217|NCT01376037|O1|Outcome|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.
Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
199218|NCT01376037|E2|Reported Event|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.
inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
199219|NCT01376037|E1|Reported Event|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.
Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
199220|NCT01375777|B10|Baseline|Total|Total of all reporting groups
199221|NCT01375777|B9|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199222|NCT01375777|B8|Baseline|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199223|NCT01375777|B7|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199224|NCT01375777|B6|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199225|NCT01375777|B5|Baseline|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199226|NCT01375777|B4|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199227|NCT01375777|B3|Baseline|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
199228|NCT01375777|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
199231|NCT01375777|P8|Participant Flow|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199232|NCT01375777|P7|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199233|NCT01375777|P6|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199234|NCT01375777|P5|Participant Flow|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199235|NCT01375777|P4|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199236|NCT01375777|P3|Participant Flow|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
199237|NCT01375777|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
199238|NCT01375777|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
199239|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199240|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199241|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199242|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199243|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199244|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199245|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
199246|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
199247|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
199248|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199249|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199250|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199251|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199252|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199253|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199254|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
199255|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
199256|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
199257|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199258|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199259|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199260|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199261|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199262|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199263|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
199264|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
199265|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
199266|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199267|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199268|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199269|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199270|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199271|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199272|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
199273|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
199274|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
199275|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199276|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199277|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199278|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199279|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199280|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199281|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
199282|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
199283|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
199284|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199285|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199286|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199287|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199288|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199289|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199290|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
199291|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
199292|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
199293|NCT01375777|E9|Reported Event|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199294|NCT01375777|E8|Reported Event|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199295|NCT01375777|E7|Reported Event|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199296|NCT01375777|E6|Reported Event|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199297|NCT01375777|E5|Reported Event|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199298|NCT01375777|E4|Reported Event|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
199299|NCT01375777|E3|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
199300|NCT01375777|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
199301|NCT01375777|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
199302|NCT01375764|B6|Baseline|Total|Total of all reporting groups
199303|NCT01375764|B5|Baseline|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199304|NCT01375764|B4|Baseline|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199305|NCT01375764|B3|Baseline|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199306|NCT01375764|B2|Baseline|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199307|NCT01375764|B1|Baseline|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199308|NCT01375764|P5|Participant Flow|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199309|NCT01375764|P4|Participant Flow|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199310|NCT01375764|P3|Participant Flow|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199311|NCT01375764|P2|Participant Flow|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199312|NCT01375764|P1|Participant Flow|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199313|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199314|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199315|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199316|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199317|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199318|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199319|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199320|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199321|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199322|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199323|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199324|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199325|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199326|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199327|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199328|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199329|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199330|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199331|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199332|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199333|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199334|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199335|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199336|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199337|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199338|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199339|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199340|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199341|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199342|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199343|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199344|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199345|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199346|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199347|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199348|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199349|NCT01375764|E5|Reported Event|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199350|NCT01375764|E4|Reported Event|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199351|NCT01375764|E3|Reported Event|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199352|NCT01375764|E2|Reported Event|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199353|NCT01375764|E1|Reported Event|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
199354|NCT01375751|B4|Baseline|Total|Total of all reporting groups
199355|NCT01375751|B3|Baseline|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199356|NCT01375751|B2|Baseline|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199357|NCT01375751|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
199358|NCT01375751|P3|Participant Flow|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199359|NCT01375751|P2|Participant Flow|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199360|NCT01375751|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
199361|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199362|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199363|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
199364|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199365|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199366|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
199367|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199368|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199369|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
199370|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199371|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199372|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
199373|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199374|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199375|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
199376|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199377|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199378|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
199379|NCT01375751|E3|Reported Event|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199380|NCT01375751|E2|Reported Event|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
199381|NCT01375751|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
199382|NCT01375660|B3|Baseline|Total|Total of all reporting groups
199383|NCT01375660|B2|Baseline|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
199384|NCT01375660|B1|Baseline|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
199385|NCT01375660|P2|Participant Flow|50K Vitamin D2|supplement of vitamin D 400 units provided to all subjects in addition to 50K vitamin D2.
199386|NCT01375660|P1|Participant Flow|Placebo|supplement of vitamin D 400 units provided to all subjects in addition to placebo.
199387|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
199388|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
199389|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
199390|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
199391|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
199392|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
199393|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
199394|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
199395|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
199396|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
199397|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
199398|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to Placebo.
199399|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
199400|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to Placebo.
199401|NCT01375660|E2|Reported Event|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition get to D2 50K.
199402|NCT01375660|E1|Reported Event|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
199403|NCT01375608|B1|Baseline|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
199404|NCT01375608|P1|Participant Flow|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
199405|NCT01375608|O1|Outcome|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
199406|NCT01375608|E1|Reported Event|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
199407|NCT01375569|B1|Baseline|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
199408|NCT01375569|P1|Participant Flow|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
199409|NCT01375569|O1|Outcome|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
199410|NCT01375569|O1|Outcome|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
199411|NCT01375569|E1|Reported Event|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
199412|NCT01375374|B1|Baseline|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.
8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.
Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
199413|NCT01375374|P1|Participant Flow|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.
8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.
Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
199414|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.
8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.
Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
199415|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.
8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.
Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
199416|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.
8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.
Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
199417|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.
8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.
Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
199418|NCT01375374|E1|Reported Event|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.
8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.
Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
199419|NCT01375127|B7|Baseline|Total|Total of all reporting groups
199420|NCT01375127|B6|Baseline|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199421|NCT01375127|B5|Baseline|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199422|NCT01375127|B4|Baseline|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199423|NCT01375127|B3|Baseline|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199424|NCT01375127|B2|Baseline|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199425|NCT01375127|B1|Baseline|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
199426|NCT01375127|P6|Participant Flow|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199519|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199427|NCT01375127|P5|Participant Flow|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199428|NCT01375127|P4|Participant Flow|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199429|NCT01375127|P3|Participant Flow|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199430|NCT01375127|P2|Participant Flow|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199431|NCT01375127|P1|Participant Flow|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
199432|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199433|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199434|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199435|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199436|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199437|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
199438|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199439|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199440|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199441|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199442|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199443|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
199444|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199445|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199446|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199520|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
200610|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
199447|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199448|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199449|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
199450|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199451|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199452|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199453|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199454|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199455|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
199456|NCT01375127|E6|Reported Event|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199457|NCT01375127|E5|Reported Event|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199458|NCT01375127|E4|Reported Event|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199459|NCT01375127|E3|Reported Event|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199460|NCT01375127|E2|Reported Event|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
199461|NCT01375127|E1|Reported Event|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
199462|NCT01375049|B1|Baseline|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
199463|NCT01375049|P1|Participant Flow|AZLI|Participants received one 28-day course of Aztreonam for Inhalation Solution (AZLI), then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
199464|NCT01375049|O1|Outcome|AZLI - Sensitivity Analysis Set|"Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Sensitivity Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a PA-positive culture from Day 28 through Day 196 or used any additional antipseudomonal antibiotics from Day 28 through Day 196."
199465|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
199466|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
199521|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199467|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
199468|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
199469|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
199470|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
199471|NCT01375049|O2|Outcome|AZLI - Did Not Meet Primary Efficacy Endpoint|"This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
199472|NCT01375049|O1|Outcome|AZLI - Met Primary Efficacy Endpoint|"This group included participants who met the primary efficacy endpoint, defined as having PA-negative cultures at all time points after cessation of active treatment through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
199473|NCT01375049|O2|Outcome|AZLI - Did Not Meet Primary Efficacy Endpoint|"This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
199474|NCT01375049|O1|Outcome|AZLI - Met Primary Efficacy Endpoint|"This group included participants who met the primary efficacy endpoint, defined as having PA-negative cultures at all time points after cessation of active treatment through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
199475|NCT01375049|O1|Outcome|AZLI - Evaluable Analysis Set|"Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196."
199476|NCT01375049|E1|Reported Event|AZLI|"Treatment-emergent adverse events and treatment-emergent serious adverse events were collected from Baseline through Day 28 plus 30 days.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
199477|NCT01374971|B1|Baseline|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
199478|NCT01374971|P1|Participant Flow|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
Certolizumab Pegol (CZP): CZP is an anti-Tumor Necrosis Factor (TNF), humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
199479|NCT01374971|O1|Outcome|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
199522|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
199523|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199524|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
199525|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199526|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
199527|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199480|NCT01374971|O1|Outcome|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
199481|NCT01374971|E1|Reported Event|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
199482|NCT01374919|B1|Baseline|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
199483|NCT01374919|P1|Participant Flow|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
199484|NCT01374919|O1|Outcome|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
199485|NCT01374919|O1|Outcome|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
199486|NCT01374919|E1|Reported Event|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
199487|NCT01374802|B1|Baseline|All Subjects|"The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.
Period 1: darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).
Period 2: faldaprevir together with DRV/r."
199488|NCT01374802|P1|Participant Flow|All Subjects|"The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.
Period 1: Darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).
Period 2: Faldaprevir together with DRV/r."
199489|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
199490|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
199491|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
199492|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
199493|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
199494|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
199495|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
199496|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
199497|NCT01374802|E2|Reported Event|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
199498|NCT01374802|E1|Reported Event|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r)once daily
199499|NCT01374568|B3|Baseline|Total|Total of all reporting groups
199500|NCT01374568|B2|Baseline|Placebo|"Placebo
Placebo: 1 pill daily"
199501|NCT01374568|B1|Baseline|Sitagliptin|"Sitagliptin
sitagliptin: sitagliptin 100mg daily"
199502|NCT01374568|P2|Participant Flow|Placebo|"Placebo
Placebo: 1 pill daily"
199503|NCT01374568|P1|Participant Flow|Sitagliptin|"Sitagliptin
sitagliptin: sitagliptin 100mg daily"
199504|NCT01374568|O2|Outcome|Placebo|"Placebo
Placebo: 1 pill daily"
199505|NCT01374568|O1|Outcome|Sitagliptin|"Sitagliptin
sitagliptin: sitagliptin 100mg daily"
199506|NCT01374568|O2|Outcome|Placebo|"Placebo
Placebo: 1 pill daily"
199507|NCT01374568|O1|Outcome|Sitagliptin|"Sitagliptin
sitagliptin: sitagliptin 100mg daily"
199508|NCT01374568|E2|Reported Event|Placebo|"Placebo
Placebo: 1 pill daily"
199509|NCT01374568|E1|Reported Event|Sitagliptin|"Sitagliptin
sitagliptin: sitagliptin 100mg daily"
199510|NCT01374451|B3|Baseline|Total|Total of all reporting groups
199511|NCT01374451|B2|Baseline|Everolimus|everolimus 10 mg once daily po alone
199512|NCT01374451|B1|Baseline|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199513|NCT01374451|P2|Participant Flow|Everolimus|everolimus 10 mg once daily po alone
199514|NCT01374451|P1|Participant Flow|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199515|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199516|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
199517|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199518|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
199528|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
199529|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199530|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
199531|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199532|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
199533|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199534|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
199535|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199536|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
199537|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199538|NCT01374451|E2|Reported Event|Everolimus|everolimus 10 mg once daily po alone
199539|NCT01374451|E1|Reported Event|Everolimus LAR + Pasireotide|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
199540|NCT01374438|B3|Baseline|Total|Total of all reporting groups
199541|NCT01374438|B2|Baseline|Placebo Capsules|"Placebo tablets contained in #00 capsules
Placebo: Placebo capsules given once daily for 90 days"
199542|NCT01374438|B1|Baseline|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules
MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
199543|NCT01374438|P2|Participant Flow|Placebo Capsules|"Placebo tablets contained in #00 capsules
Placebo: Placebo capsules given once daily for 90 days"
199544|NCT01374438|P1|Participant Flow|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules
MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
199545|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules
Placebo: Placebo capsules given once daily for 90 days"
199546|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules
MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
199547|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules
Placebo: Placebo capsules given once daily for 90 days"
199548|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules
MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
199549|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules
Placebo: Placebo capsules given once daily for 90 days"
199550|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules
MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
199551|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules
Placebo: Placebo capsules given once daily for 90 days"
199552|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules
MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
199553|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules
Placebo: Placebo capsules given once daily for 90 days"
199554|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules
MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
199555|NCT01374438|E2|Reported Event|Placebo Capsules|"Placebo tablets contained in #00 capsules
Placebo: Placebo capsules given once daily for 90 days"
199556|NCT01374438|E1|Reported Event|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules
MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
199557|NCT01374425|B3|Baseline|Total|Total of all reporting groups
199558|NCT01374425|B2|Baseline|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199559|NCT01374425|B1|Baseline|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199560|NCT01374425|P2|Participant Flow|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI) until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199561|NCT01374425|P1|Participant Flow|Bevacizumab + mFOLFOX6|Participants with untreated metastatic colorectal cancer (mCRC) who were candidates for first-line therapy received bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) until disease progression or unacceptable toxicity. Bevacizumab was given as 5 milligrams per kilogram (mg/kg), leucovorin as 400 milligrams per meter-squared (mg/m^2), oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via intravenous (IV) infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199908|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199562|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
199563|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
199564|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
199565|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
199566|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
199567|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
199568|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
199569|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
199909|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
200372|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
199570|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
199571|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
199572|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
199573|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
199574|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
199575|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
199576|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
199577|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
199910|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
200611|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
199578|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199579|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199580|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199581|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199582|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199583|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199584|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199585|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199656|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
200447|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
199586|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199587|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199588|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199589|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199590|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199591|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199592|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199593|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199594|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199668|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199911|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199595|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199596|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199597|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199598|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199599|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199600|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199601|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199602|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199603|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199912|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199604|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199605|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199606|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199607|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199608|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199609|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199610|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199611|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199612|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199913|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
200448|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
199613|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199614|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199615|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199616|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199617|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199618|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
199619|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
199620|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
199621|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
199805|NCT01373918|P2|Participant Flow|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199622|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
199623|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
199624|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
199625|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
199626|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
199627|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 picograms per milliliter (pg/mL) at Baseline were included in separate analyses.
199628|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199629|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199680|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199630|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199631|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level less than or equal to (≤) 1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199632|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
199633|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level greater than (>) 1.7 × 10^-3 ERCC-1/B-actin messenger ribonucleic acid (mRNA) at Baseline were included in separate analyses.
199634|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199635|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199636|NCT01374425|E2|Reported Event|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199637|NCT01374425|E1|Reported Event|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
199638|NCT01373671|B1|Baseline|Mammography Exam|"Siemens DBT scan
SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
199639|NCT01373671|P1|Participant Flow|Mammography Exam|"Siemens DBT scan
SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
199640|NCT01373671|O2|Outcome|FFDM Only|FFDM exam only
199641|NCT01373671|O1|Outcome|FFDM and DBT|FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration
199642|NCT01373671|E1|Reported Event|Mammography Exam|"Siemens DBT scan
SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
199643|NCT01374269|B3|Baseline|Total|Total of all reporting groups
199644|NCT01374269|B2|Baseline|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199839|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
199840|NCT01373450|E4|Reported Event|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
199645|NCT01374269|B1|Baseline|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199646|NCT01374269|P2|Participant Flow|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199647|NCT01374269|P1|Participant Flow|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199648|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199649|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199650|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199651|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199652|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199653|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199654|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199655|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199841|NCT01373450|E3|Reported Event|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
199842|NCT01373450|E2|Reported Event|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
199657|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199658|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199659|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199660|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199661|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199662|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199663|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199664|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199665|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199666|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199667|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199843|NCT01373450|E1|Reported Event|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
199844|NCT01373346|B1|Baseline|Long Limb Roux-en Y Reconstruction|Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
199669|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199670|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199671|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199672|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199673|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199674|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199675|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199676|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199677|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199678|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199679|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199845|NCT01373346|P1|Participant Flow|Long Limb Roux-en Y Reconstruction|Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
199681|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199682|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199683|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199684|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199685|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199686|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199687|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199688|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199689|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199690|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199691|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199901|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199692|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199693|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199694|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199695|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199696|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199697|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199698|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199699|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199700|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199701|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199702|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199714|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199703|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199704|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199705|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199706|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199707|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199708|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199709|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199710|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199711|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199712|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199713|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199902|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199715|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199716|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199717|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199718|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199719|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199720|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199721|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199722|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199723|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199724|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199725|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199903|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
200612|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
199726|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199727|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199728|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199729|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199730|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199731|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199732|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199733|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199734|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199735|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199736|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199748|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199737|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199738|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199739|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199740|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199741|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199742|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199743|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199744|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199745|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199746|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199747|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199904|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199749|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199750|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199751|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199752|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199753|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199754|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199755|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199756|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199757|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199758|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199759|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199905|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199760|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199761|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199762|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199763|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199764|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199765|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199766|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199767|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199768|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199769|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199770|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199804|NCT01373918|B1|Baseline|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199906|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199771|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199772|NCT01374269|E2|Reported Event|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
199773|NCT01374269|E1|Reported Event|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
199774|NCT01374178|B1|Baseline|Entire Study Population|"For the LY2963016 first, then Lantus group: A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).
For the Lantus first, then LY2963016 group: A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours)."
199775|NCT01374178|P2|Participant Flow|Lantus First, Then LY2963016|A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours).
199776|NCT01374178|P1|Participant Flow|LY2963016 First, Then Lantus|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).
199777|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
199778|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
199779|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
199780|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
199781|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
199782|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
199783|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
199784|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
199785|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
199786|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
199787|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
199788|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
199789|NCT01374178|E2|Reported Event|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
199790|NCT01374178|E1|Reported Event|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
199791|NCT01374087|B3|Baseline|Total|Total of all reporting groups
199792|NCT01374087|B2|Baseline|Brachytherapy|Brachytherapy: Low or high dose rate.
199793|NCT01374087|B1|Baseline|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
199794|NCT01374087|P2|Participant Flow|Brachytherapy|Brachytherapy: Low or high dose rate.
199795|NCT01374087|P1|Participant Flow|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
199796|NCT01374087|O2|Outcome|Brachytherapy|Brachytherapy: Low or high dose rate.
199797|NCT01374087|O1|Outcome|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
199798|NCT01374087|O2|Outcome|Brachytherapy|Brachytherapy: Low or high dose rate.
199799|NCT01374087|O1|Outcome|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
199800|NCT01374087|E2|Reported Event|Brachytherapy|Brachytherapy: Low or high dose rate.
199801|NCT01374087|E1|Reported Event|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
199802|NCT01373918|B3|Baseline|Total|Total of all reporting groups
199803|NCT01373918|B2|Baseline|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199806|NCT01373918|P1|Participant Flow|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199807|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199808|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199809|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199810|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199811|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199812|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199813|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199814|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199815|NCT01373918|E2|Reported Event|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199816|NCT01373918|E1|Reported Event|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).
Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
199817|NCT01373450|B1|Baseline|All Treated Participants|
199818|NCT01373450|P6|Participant Flow|Pbo--> Lg-0.6--> OXM--> Lg-1.2|Participants received Placebo in the first, Liraglutide 0.6 mg in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Liraglutide 1.2 mg in the fourth period
199819|NCT01373450|P5|Participant Flow|OXM--> Pbo--> Lg-0.6--> Pbo|Participants received Oxyntomodulin 3.0 pmol/kg/min in the first; Placebo in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
199820|NCT01373450|P4|Participant Flow|Lg-0.6--> OXM--> Pbo--> Lg-1.2|Participants received Liraglutide 0.6 mg in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Placebo in the third and Liraglutide 1.2 mg in the fourth period
199821|NCT01373450|P3|Participant Flow|Pbo--> OXM--> Lg-0.6-->Pbo|Participants received Placebo in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
199822|NCT01373450|P2|Participant Flow|Lg-0.6 mg--> Pbo--> OXM--> Pbo|Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the fourth period
199823|NCT01373450|P1|Participant Flow|OXM --> Lg-0.6--> Pbo--> Lg-1.2|Participants received Oxyntomodulin (OXM) 3.0 pmol/kg/min in the first, Liraglutide (Lg) 0.6 mg in the second, Placebo (Pbo) in the third, and Liraglutide 1.2 mg in the fourth period
199824|NCT01373450|O4|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
199825|NCT01373450|O3|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
199826|NCT01373450|O2|Outcome|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
199827|NCT01373450|O1|Outcome|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
199828|NCT01373450|O4|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
199829|NCT01373450|O3|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
199830|NCT01373450|O2|Outcome|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
199831|NCT01373450|O1|Outcome|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
199832|NCT01373450|O2|Outcome|Placebo Period 2|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
199833|NCT01373450|O1|Outcome|Placebo Period 1|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
199834|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
199835|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
199836|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
199837|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
199838|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
199846|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
199847|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
199848|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
199849|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
199850|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
199851|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
199852|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
199853|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
199854|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|"Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.
Until end of study (on average 14.8 months), operation related mortality of Gastric cancer patient with type 2 diabetes who receive total or Subtotal gastrectomy with long limb Roux en Y reconstruction were analyzed."
199855|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
199856|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
199857|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
199858|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
199859|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
199907|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
200449|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
199860|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
199861|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
199862|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Morbidity after operation were analyzed until end of study (on average 14.8 months)
199863|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
199864|NCT01373346|E1|Reported Event|Long-limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.
199865|NCT01373294|B3|Baseline|Total|Total of all reporting groups
199866|NCT01373294|B2|Baseline|B: Control Arm|Bacille Calmette-Guerrin (BCG).
199867|NCT01373294|B1|Baseline|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
199868|NCT01373294|P2|Participant Flow|B: Control Arm|Bacille Calmette-Guerrin (BCG).
199869|NCT01373294|P1|Participant Flow|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
199870|NCT01373294|O2|Outcome|B: Control Arm|Bacille Calmette-Guerrin (BCG).
199871|NCT01373294|O1|Outcome|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
199872|NCT01373294|O1|Outcome|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
199873|NCT01373294|E2|Reported Event|B: Control Arm|Bacille Calmette-Guerrin (BCG).
199874|NCT01373294|E1|Reported Event|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
199875|NCT01373281|B3|Baseline|Total|Total of all reporting groups
199876|NCT01373281|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
199877|NCT01373281|B1|Baseline|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
199878|NCT01373281|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
199879|NCT01373281|P1|Participant Flow|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
199880|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
199881|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
199882|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
199883|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
199884|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
199885|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
199886|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
199887|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
199888|NCT01373281|O2|Outcome|Placebo Group|Subset of subjects who received at least one dose of the placebo vaccine.
199889|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subset of subjects who received at least one dose of CYD Dengue vaccine.
199890|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
199891|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
199892|NCT01373281|E2|Reported Event|Placebo Group|Safety data were collected in subjects that received at least 1 dose of placebo vaccine.
199893|NCT01373281|E1|Reported Event|CYD Dengue Vaccine Group|Safety data were collected in subjects that received at least 1 dose of CYD dengue vaccine.
199894|NCT01372995|B4|Baseline|Total|Total of all reporting groups
199895|NCT01372995|B3|Baseline|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199896|NCT01372995|B2|Baseline|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199897|NCT01372995|B1|Baseline|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199898|NCT01372995|P3|Participant Flow|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199899|NCT01372995|P2|Participant Flow|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199900|NCT01372995|P1|Participant Flow|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199914|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199915|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199916|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199917|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199918|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199919|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199920|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199921|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199922|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199923|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199924|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199925|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199926|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199927|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199928|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199929|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199930|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199931|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199932|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199933|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199934|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199935|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199936|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199937|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199938|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199939|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199940|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
199941|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
199942|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199943|NCT01372995|E3|Reported Event|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally.
199944|NCT01372995|E2|Reported Event|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally.
199945|NCT01372995|E1|Reported Event|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
199946|NCT01372878|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
199947|NCT01372878|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
199948|NCT01372878|O1|Outcome|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
199949|NCT01372878|O1|Outcome|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
199967|NCT01372748|P2|Participant Flow|Continuous Chest Compressions|"Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
199950|NCT01372878|E1|Reported Event|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
199951|NCT01372813|B1|Baseline|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199952|NCT01372813|P1|Participant Flow|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199953|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199954|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199955|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199956|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199957|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199958|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199959|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199960|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199961|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199962|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199963|NCT01372813|E1|Reported Event|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
199964|NCT01372748|B3|Baseline|Total|Total of all reporting groups
199965|NCT01372748|B2|Baseline|Continuous Chest Compressions|"Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
199966|NCT01372748|B1|Baseline|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations
Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
199968|NCT01372748|P1|Participant Flow|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations
Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
199969|NCT01372748|O2|Outcome|Continuous Chest Compressions|"Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
199970|NCT01372748|O1|Outcome|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations
Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
199971|NCT01372748|O2|Outcome|Continuous Chest Compressions|"Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
199972|NCT01372748|O1|Outcome|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations
Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
199973|NCT01372748|E2|Reported Event|Continuous Chest Compressions|"Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
199974|NCT01372748|E1|Reported Event|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations
Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
199975|NCT01372605|B3|Baseline|Total|Total of all reporting groups
199976|NCT01372605|B2|Baseline|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
199977|NCT01372605|B1|Baseline|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
199978|NCT01372605|P2|Participant Flow|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
199979|NCT01372605|P1|Participant Flow|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
199980|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
199981|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
199982|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
199983|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
199984|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
199985|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
199986|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
200009|NCT01372462|B1|Baseline|Overall Study Group|Crossover design. Subject were randomized to complete all 4 study arms: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment
199987|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
199988|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
199989|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
199990|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
199991|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
199992|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
199993|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
199994|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
199995|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
199996|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
199997|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
199998|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
199999|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
200000|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
200001|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
200002|NCT01372605|E2|Reported Event|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
200003|NCT01372605|E1|Reported Event|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
200004|NCT01372501|B1|Baseline|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device
Endobarrier Liner: Medical device placed endoscopically in the duodenum"
200005|NCT01372501|P1|Participant Flow|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum"
200006|NCT01372501|O1|Outcome|EndoBarrier Liner Device|Endobarrier Liner: Medical device placed endoscopically in the duodenum
200007|NCT01372501|O1|Outcome|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device
Endobarrier Liner: Medical device placed endoscopically in the duodenum"
200008|NCT01372501|E1|Reported Event|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device
Endobarrier Liner: Medical device placed endoscopically in the duodenum"
200450|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200010|NCT01372462|P1|Participant Flow|All Study Participants|"All subjects completed all 4 visit days in which they were randomized to receive which treatment to receive first: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment.
Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen."
200011|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
200012|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).
Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
200013|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
200014|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
200015|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
200016|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).
Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
200017|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
200018|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
200019|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
200020|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).
Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
200021|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
200022|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
200023|NCT01372462|E4|Reported Event|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
200024|NCT01372462|E3|Reported Event|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).
Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
200025|NCT01372462|E2|Reported Event|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
200026|NCT01372462|E1|Reported Event|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
200027|NCT01372410|B1|Baseline|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200028|NCT01372410|P8|Participant Flow|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200029|NCT01372410|P7|Participant Flow|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200030|NCT01372410|P6|Participant Flow|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200031|NCT01372410|P5|Participant Flow|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200032|NCT01372410|P4|Participant Flow|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200033|NCT01372410|P3|Participant Flow|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200105|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
200034|NCT01372410|P2|Participant Flow|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200035|NCT01372410|P1|Participant Flow|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200036|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200037|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200038|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200039|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200040|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200041|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200042|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200043|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200044|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200045|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200046|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200047|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200048|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200049|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200050|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200051|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200052|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200053|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200054|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200055|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200056|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200057|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200058|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200059|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200060|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200061|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200062|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200063|NCT01372410|E8|Reported Event|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200064|NCT01372410|E7|Reported Event|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200065|NCT01372410|E6|Reported Event|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200066|NCT01372410|E5|Reported Event|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200067|NCT01372410|E4|Reported Event|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200451|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
200068|NCT01372410|E3|Reported Event|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200069|NCT01372410|E2|Reported Event|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200070|NCT01372410|E1|Reported Event|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
200071|NCT01372384|B1|Baseline|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
200072|NCT01372384|P1|Participant Flow|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
200073|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
200074|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
200075|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
200076|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
200077|NCT01372384|E1|Reported Event|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
200078|NCT01372202|B4|Baseline|Total|Total of all reporting groups
200079|NCT01372202|B3|Baseline|Arm C|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
200080|NCT01372202|B2|Baseline|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
Cisplatin: Paclitaxel and cisplatin:
Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
Cisplatin 75 mg/m² days 1, 29.
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu: Oxaliplatin & 5-fu:
Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation
Cisplatin/5-fluorouracil:
5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
200081|NCT01372202|B1|Baseline|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy
Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin: Paclitaxel and cisplatin:
Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 – 56)."
200082|NCT01372202|P3|Participant Flow|Cisplatin With 5 Fu|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
200083|NCT01372202|P2|Participant Flow|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
Cisplatin: Paclitaxel and cisplatin:
Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
Cisplatin 75 mg/m² days 1, 29.
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu: Oxaliplatin & 5-fu:
Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation
Cisplatin/5-fluorouracil:
5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
200084|NCT01372202|P1|Participant Flow|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy
Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin: Paclitaxel and cisplatin:
Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 – 56)."
200085|NCT01372202|O3|Outcome|Arm C|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
200104|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
200452|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200086|NCT01372202|O2|Outcome|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
Cisplatin: Paclitaxel and cisplatin:
Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
Cisplatin 75 mg/m² days 1, 29.
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu: Oxaliplatin & 5-fu:
Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation
Cisplatin/5-fluorouracil:
5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
200087|NCT01372202|O1|Outcome|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy
Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin: Paclitaxel and cisplatin:
Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 – 56)."
200088|NCT01372202|E3|Reported Event|Cisplatin With 5 Fu|Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
200089|NCT01372202|E2|Reported Event|Arm B|"Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
Cisplatin: Paclitaxel and cisplatin:
Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
Cisplatin 75 mg/m² days 1, 29.
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu: Oxaliplatin & 5-fu:
Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu 180 mg/m2 prolonged infusion day 1 of radiation & completing on the final day of radiation
Cisplatin/5-fluorouracil:
5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy."
200090|NCT01372202|E1|Reported Event|Arm A|"Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy
Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin: Paclitaxel and cisplatin:
Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 – 56)."
200091|NCT01372150|B4|Baseline|Total|Total of all reporting groups
200092|NCT01372150|B3|Baseline|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
200093|NCT01372150|B2|Baseline|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
200094|NCT01372150|B1|Baseline|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
200095|NCT01372150|P3|Participant Flow|Desvenlafaxine Succinate Sustained Release (DVS SR)|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
200096|NCT01372150|P2|Participant Flow|Fluoxetine|Fluoxetine capsules 10 (milligram) mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily as appropriate for 1 week (taper/transition phase).
200097|NCT01372150|P1|Participant Flow|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
200098|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
200099|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
200100|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
200101|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
200102|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
200103|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
200106|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
200107|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
200108|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
200109|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
200110|NCT01372150|E3|Reported Event|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
200111|NCT01372150|E2|Reported Event|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
200112|NCT01372150|E1|Reported Event|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
200113|NCT01371994|B3|Baseline|Total|Total of all reporting groups
200114|NCT01371994|B2|Baseline|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200115|NCT01371994|B1|Baseline|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200116|NCT01371994|P2|Participant Flow|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200117|NCT01371994|P1|Participant Flow|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200118|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200119|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200120|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200121|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200122|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200123|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200124|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200125|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200126|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200127|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200128|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200129|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200130|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200131|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200132|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200133|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200134|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200135|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200136|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200137|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200138|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200139|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200140|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200141|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200142|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200143|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200144|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200145|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200146|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200147|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200148|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200149|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200150|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200151|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200152|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200153|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200154|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200155|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200156|NCT01371994|E2|Reported Event|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
200157|NCT01371994|E1|Reported Event|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
200158|NCT01371877|B3|Baseline|Total|Total of all reporting groups
200159|NCT01371877|B2|Baseline|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.
Vitamin D: Vitamin D 600 IU per day"
200160|NCT01371877|B1|Baseline|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.
Vitamin D: Vitamin D 4000 IU per day for 3 months"
200161|NCT01371877|P2|Participant Flow|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.
Vitamin D: Vitamin D 600 IU per day"
200162|NCT01371877|P1|Participant Flow|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.
Vitamin D: Vitamin D 4000 IU per day for 3 months"
200163|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.
Vitamin D: Vitamin D 600 IU per day"
200164|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.
Vitamin D: Vitamin D 4000 IU per day for 3 months"
200165|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.
Vitamin D: Vitamin D 600 IU per day"
200166|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.
Vitamin D: Vitamin D 4000 IU per day for 3 months"
200167|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.
Vitamin D: Vitamin D 600 IU per day"
200168|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.
Vitamin D: Vitamin D 4000 IU per day for 3 months"
200169|NCT01371877|E2|Reported Event|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.
Vitamin D: Vitamin D 600 IU per day"
200170|NCT01371877|E1|Reported Event|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.
Vitamin D: Vitamin D 4000 IU per day for 3 months"
200171|NCT01371851|B3|Baseline|Total|Total of all reporting groups
200172|NCT01371851|B2|Baseline|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
200206|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200373|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200173|NCT01371851|B1|Baseline|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
200174|NCT01371851|P2|Participant Flow|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
200175|NCT01371851|P1|Participant Flow|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
200176|NCT01371851|O2|Outcome|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
200177|NCT01371851|O1|Outcome|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
200178|NCT01371851|E2|Reported Event|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
200179|NCT01371851|E1|Reported Event|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
200180|NCT01371838|B3|Baseline|Total|Total of all reporting groups
200181|NCT01371838|B2|Baseline|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200182|NCT01371838|B1|Baseline|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200183|NCT01371838|P2|Participant Flow|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200184|NCT01371838|P1|Participant Flow|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200185|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200186|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200187|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200188|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200189|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200190|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200191|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200192|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200193|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200194|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200195|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200196|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200197|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200198|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200199|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200200|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200201|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200202|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200203|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200204|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200205|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200207|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200208|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200209|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200210|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200211|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200212|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200213|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200214|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200215|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200216|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200217|NCT01371838|E2|Reported Event|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
200218|NCT01371838|E1|Reported Event|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
200219|NCT01371825|B1|Baseline|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200220|NCT01371825|P1|Participant Flow|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200221|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200222|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200223|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200224|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200225|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200251|NCT01371747|B4|Baseline|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200604|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
200226|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200227|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200228|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200229|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200230|NCT01371825|E1|Reported Event|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
200231|NCT01371786|B3|Baseline|Total|Total of all reporting groups
200232|NCT01371786|B2|Baseline|Sequence Mometasone Aqueous / Ciclesonide Nasal Aerosol|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canistermometasone Aqueous (AQ) nasal spray : A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
200233|NCT01371786|B1|Baseline|Sequence Ciclesonide Nasal Aerosol /Mometsasone Aqueous|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
200234|NCT01371786|P2|Participant Flow|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
200235|NCT01371786|P1|Participant Flow|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
200236|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
200237|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
200238|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
200239|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
200240|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
200241|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
200242|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
200243|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
200244|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
200245|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
200246|NCT01371786|E2|Reported Event|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
200247|NCT01371786|E1|Reported Event|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
200248|NCT01371747|B7|Baseline|Total|Total of all reporting groups
200249|NCT01371747|B6|Baseline|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200250|NCT01371747|B5|Baseline|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day
200252|NCT01371747|B3|Baseline|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200253|NCT01371747|B2|Baseline|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200254|NCT01371747|B1|Baseline|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
200255|NCT01371747|P6|Participant Flow|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200256|NCT01371747|P5|Participant Flow|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200257|NCT01371747|P4|Participant Flow|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200258|NCT01371747|P3|Participant Flow|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200259|NCT01371747|P2|Participant Flow|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200260|NCT01371747|P1|Participant Flow|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
200261|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200262|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200263|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200264|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200265|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200266|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
200267|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200268|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200269|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200270|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200271|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200272|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day
200273|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200274|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200275|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200276|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200277|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200278|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
200279|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200280|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200281|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200282|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200283|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200284|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
200285|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200286|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200287|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200288|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200289|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200290|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
200291|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200292|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200293|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200294|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200295|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200296|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
200297|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200298|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200299|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200300|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200301|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200302|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
200303|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200304|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200305|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200306|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200307|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200308|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
200309|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200310|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200311|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200312|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200313|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200314|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
200315|NCT01371747|E6|Reported Event|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
200316|NCT01371747|E5|Reported Event|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200317|NCT01371747|E4|Reported Event|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200605|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
200318|NCT01371747|E3|Reported Event|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
200319|NCT01371747|E2|Reported Event|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
200320|NCT01371747|E1|Reported Event|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
200321|NCT01371734|B4|Baseline|Total|Total of all reporting groups
200322|NCT01371734|B3|Baseline|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200323|NCT01371734|B2|Baseline|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200324|NCT01371734|B1|Baseline|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200325|NCT01371734|P3|Participant Flow|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200326|NCT01371734|P2|Participant Flow|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200327|NCT01371734|P1|Participant Flow|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200328|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200329|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200330|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200331|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200332|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200333|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200334|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200335|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200336|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200337|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200446|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200338|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200339|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200340|NCT01371734|E3|Reported Event|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200341|NCT01371734|E2|Reported Event|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200342|NCT01371734|E1|Reported Event|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
200343|NCT01371721|B4|Baseline|Total|Total of all reporting groups
200344|NCT01371721|B3|Baseline|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200345|NCT01371721|B2|Baseline|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200346|NCT01371721|B1|Baseline|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200347|NCT01371721|P3|Participant Flow|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200348|NCT01371721|P2|Participant Flow|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200349|NCT01371721|P1|Participant Flow|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200350|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200351|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200352|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200353|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200354|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200355|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200356|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200357|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200358|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200359|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200360|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200361|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200362|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200363|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200364|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200365|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200366|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200367|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200368|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200369|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200370|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200371|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200374|NCT01371721|E4|Reported Event|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200375|NCT01371721|E3|Reported Event|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200376|NCT01371721|E2|Reported Event|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200377|NCT01371721|E1|Reported Event|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
200378|NCT01371708|B4|Baseline|Total|Total of all reporting groups
200379|NCT01371708|B3|Baseline|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200380|NCT01371708|B2|Baseline|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200381|NCT01371708|B1|Baseline|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200382|NCT01371708|P3|Participant Flow|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200383|NCT01371708|P2|Participant Flow|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200384|NCT01371708|P1|Participant Flow|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200385|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
200386|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200387|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200388|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200389|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
200390|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200391|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200392|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200393|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
200394|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200395|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200396|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200397|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
200398|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200399|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200400|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200401|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
200402|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200403|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200404|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200405|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
200406|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200407|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200408|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200409|NCT01371708|E4|Reported Event|Combination Group|Combination of 3 groups of participants from previous study B2061032 received DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200410|NCT01371708|E3|Reported Event|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200411|NCT01371708|E2|Reported Event|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing(20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200412|NCT01371708|E1|Reported Event|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
200413|NCT01371643|B3|Baseline|Total|Total of all reporting groups
200414|NCT01371643|B2|Baseline|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery"
200415|NCT01371643|B1|Baseline|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR"
200416|NCT01371643|P2|Participant Flow|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery"
200417|NCT01371643|P1|Participant Flow|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR"
200418|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery"
200419|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR"
200420|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery"
200421|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR"
200422|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery"
200423|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR"
200424|NCT01371643|E2|Reported Event|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Octreotide LAR
transsphenoidal surgery"
200425|NCT01371643|E1|Reported Event|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery
Octreotide LAR"
200426|NCT01371565|B1|Baseline|Mifepristone|At doses from 300mg/day up to 1200mg/day
200427|NCT01371565|P1|Participant Flow|Mifepristone|At doses from 300mg/day up to 1200mg/day
200428|NCT01371565|O1|Outcome|Mifepristone|At doses from 300mg/day up to 1200mg/day
200429|NCT01371565|E1|Reported Event|Mifepristone|At doses from 300mg/day up to 1200mg/day
200430|NCT01371552|B1|Baseline|Overall Study|This reporting group includes all enrolled participants.
200431|NCT01371552|P6|Participant Flow|Filcon II 3 / Delefilcon A / Narafilcon A|Part 1: Filcon II 3, then Delefilcon A, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
200432|NCT01371552|P5|Participant Flow|Narafilcon A / Delefilcon A / Filcon II 3|Part 1: Narafilcon A, then Delefilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
200433|NCT01371552|P4|Participant Flow|Delefilcon A / Narafilcon A / Filcon II 3|Part 1: Delefilcon A, then Narafilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
200434|NCT01371552|P3|Participant Flow|Filcon II 3 / Narafilcon A / Delefilcon A|Part 1: Filcon II 3, then Narafilcon A, the Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
200435|NCT01371552|P2|Participant Flow|Narafilcon A / Filcon II 3 / Delefilcon A|Part 1: Narafilcon A, then Filcon II 3, then Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
200436|NCT01371552|P1|Participant Flow|Delefilcon A / Filcon II 3 / Narafilcon A|Part 1: Delefilcon A, then Filcon II 3, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
200437|NCT01371552|O1|Outcome|Delefilcon A - All Wearers|Delefilcon A contact lenses worn in a daily disposable mode for 7 days in Part 2, all wearers
200438|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200439|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
200440|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200441|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200442|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
200443|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200444|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200445|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
200453|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200454|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
200455|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200456|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200457|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
200458|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200459|NCT01371552|E3|Reported Event|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200460|NCT01371552|E2|Reported Event|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
200461|NCT01371552|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
200462|NCT01371539|B1|Baseline|Overall|All enrolled and dispensed participants
200463|NCT01371539|P2|Participant Flow|Comfilcon A / Lotrafilcon B|Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
200464|NCT01371539|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
200465|NCT01371539|O2|Outcome|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
200466|NCT01371539|O1|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
200467|NCT01371539|O2|Outcome|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
200468|NCT01371539|O1|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
200469|NCT01371539|E2|Reported Event|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
200470|NCT01371539|E1|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
200471|NCT01371006|B3|Baseline|Total|Total of all reporting groups
200472|NCT01371006|B2|Baseline|Group B: 600 mg Efavirenz+240 mg Feldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.
Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.
oral administration with water after food intake."
200473|NCT01371006|B1|Baseline|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.
Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.
oral administration with water after food intake."
200474|NCT01371006|P2|Participant Flow|Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.
Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.
oral administration with water after food intake."
200475|NCT01371006|P1|Participant Flow|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.
Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.
oral administration with water after food intake."
200476|NCT01371006|O5|Outcome|Total On-treatment|Total number of participants with drug related adverse events during treatment.
200477|NCT01371006|O4|Outcome|Faldaprevir+Midazolam+Efavirenz|During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam
200478|NCT01371006|O3|Outcome|Faldaprevir+Midazolam|During treatment with Faldaprevir and single-dose Midazolam.
200479|NCT01371006|O2|Outcome|Faldaprevir|During treatment with Faldaprevir.
200480|NCT01371006|O1|Outcome|Midazolam|Treatment with single-dose Midazolam.
200481|NCT01371006|O4|Outcome|Total On-treatment|Total number of participants with drug related adverse events during treatment.
200482|NCT01371006|O3|Outcome|Efavirenz+Faldaprevir|During treatment with Faldaprevir and single-dose Efavirenz.
200483|NCT01371006|O2|Outcome|Faldaprevir|During treatment with Faldaprevir.
200484|NCT01371006|O1|Outcome|Efavirenz|Treatment with single-dose Efavirenz.
200485|NCT01371006|O2|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.
Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.
oral administration with water after food intake."
200486|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.
Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.
oral administration with water after food intake."
200487|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.
Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.
oral administration with water after food intake."
200488|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.
Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.
oral administration with water after food intake."
200489|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.
Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.
oral administration with water after food intake."
200490|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.
Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.
oral administration with water after food intake."
200491|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.
Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.
oral administration with water after food intake."
200492|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.
Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.
oral administration with water after food intake."
200493|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.
Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.
oral administration with water after food intake."
200494|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.
Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.
oral administration with water after food intake."
200495|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.
Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.
oral administration with water after food intake."
200496|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
200497|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
200498|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
200499|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
200500|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
200501|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
200502|NCT01371006|O2|Outcome|50 mg Efavirenz+240 mg Faldaprevir|single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)
200503|NCT01371006|O1|Outcome|50 mg Efavirenz|single oral administration of 50 mg Efavirenz dosed alone (Day 1)
200504|NCT01371006|O2|Outcome|50 mg Efavirenz+240 mg Faldaprevir|single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)
200505|NCT01371006|O1|Outcome|50 mg Efavirenz|single oral administration of 50 mg Efavirenz dosed alone (Day 1)
200506|NCT01371006|E7|Reported Event|Group B: Faldaprevir+Midazolam+Efavirenz|During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam in Group B.
200507|NCT01371006|E6|Reported Event|Group B: Faldaprevir+Midazolam|During treatment with Faldaprevir and single-dose Midazolam in Group B.
200508|NCT01371006|E5|Reported Event|Group B: Faldaprevir|During treatment with Faldaprevir in Group B.
200509|NCT01371006|E4|Reported Event|Group B: Midazolam|Treatment with single-dose Midazolam in Group B.
200510|NCT01371006|E3|Reported Event|Group A: Faldaprevir+Efavirenz|During treatment with Faldaprevir and single-dose Efavirenz in Group A.
200511|NCT01371006|E2|Reported Event|Group A: Faldaprevir|During treatment with Faldaprevir in Group A.
200512|NCT01371006|E1|Reported Event|Group A: Efavirenz|Treatment with single-dose Efavirenz in Group A.
200513|NCT01370863|B3|Baseline|Total|Total of all reporting groups
200514|NCT01370863|B2|Baseline|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
200515|NCT01370863|B1|Baseline|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
200516|NCT01370863|P2|Participant Flow|Placebo|Matching placebo tablet administered three times daily (t.i.d.) for 4 weeks in addition to stable PPI treatment
200517|NCT01370863|P1|Participant Flow|SPD557|0.5 mg tablet administered 3 times daily (t.i.d.) for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
200518|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
200519|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
200520|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
200521|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
200522|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
200523|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
200524|NCT01370863|E2|Reported Event|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
200525|NCT01370863|E1|Reported Event|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
200526|NCT01370837|B4|Baseline|Total|Total of all reporting groups
200527|NCT01370837|B3|Baseline|Polyneuropathy|"Patients with diabetes and polyneuropathy.
Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200528|NCT01370837|B2|Baseline|Diabetes|"Patients with diabetes mellitus without polyneuropathy.
Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200606|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
200529|NCT01370837|B1|Baseline|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200530|NCT01370837|P3|Participant Flow|Polyneuropathy|"Patients with diabetes and polyneuropathy.
Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200531|NCT01370837|P2|Participant Flow|Diabetes|"Patients with diabetes mellitus without polyneuropathy.
Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200532|NCT01370837|P1|Participant Flow|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200533|NCT01370837|O3|Outcome|Polyneuropathy|"Patients with diabetes and polyneuropathy.
Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200534|NCT01370837|O2|Outcome|Diabetes|"Patients with diabetes mellitus without polyneuropathy.
Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200535|NCT01370837|O1|Outcome|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200536|NCT01370837|E3|Reported Event|Polyneuropathy|"Patients with diabetes and polyneuropathy.
Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200537|NCT01370837|E2|Reported Event|Diabetes|"Patients with diabetes mellitus without polyneuropathy.
Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200538|NCT01370837|E1|Reported Event|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
200539|NCT01370733|B3|Baseline|Total|Total of all reporting groups
200540|NCT01370733|B2|Baseline|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200541|NCT01370733|B1|Baseline|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200542|NCT01370733|P2|Participant Flow|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200543|NCT01370733|P1|Participant Flow|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200544|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200545|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200546|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200547|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200548|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200549|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200550|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200551|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200552|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200553|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200554|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200555|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200556|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200557|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200558|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200559|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200560|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200561|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200562|NCT01370733|E2|Reported Event|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device
SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
200563|NCT01370733|E1|Reported Event|Active sTMS|"Treatment with the NEST-1 Device
NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
200564|NCT01370694|B1|Baseline|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
200565|NCT01370694|P1|Participant Flow|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
200566|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
200567|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
200568|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
200569|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
200607|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
200608|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
200570|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
200571|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
200572|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
200573|NCT01370694|E1|Reported Event|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
200574|NCT01370655|B13|Baseline|Total|Total of all reporting groups
200575|NCT01370655|B12|Baseline|Treatment D → Treament B|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
200576|NCT01370655|B11|Baseline|Treatment B → Treatment D|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
200577|NCT01370655|B10|Baseline|Treatment C → Treatment B|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
200578|NCT01370655|B9|Baseline|Treatment B → Treatment C|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
200579|NCT01370655|B8|Baseline|Treatment B → Treatment A|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
200580|NCT01370655|B7|Baseline|Treatment A → Treatment B|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
200581|NCT01370655|B6|Baseline|Treatment C → Treatment D|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
200582|NCT01370655|B5|Baseline|Treament D → Treatment C|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
200583|NCT01370655|B4|Baseline|Treatment D → Treatment A|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
200584|NCT01370655|B3|Baseline|Treatment A → Treatment D|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
200585|NCT01370655|B2|Baseline|Treatment C → Treatment A|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
200586|NCT01370655|B1|Baseline|Treatment A → Treatment C|Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
200587|NCT01370655|P12|Participant Flow|Treatment D → Treament B|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
200588|NCT01370655|P11|Participant Flow|Treatment B → Treatment D|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
200589|NCT01370655|P10|Participant Flow|Treatment C → Treatment B|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
200590|NCT01370655|P9|Participant Flow|Treatment B → Treatment C|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
200591|NCT01370655|P8|Participant Flow|Treatment B → Treatment A|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
200592|NCT01370655|P7|Participant Flow|Treatment A → Treatment B|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
200593|NCT01370655|P6|Participant Flow|Treatment C → Treatment D|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
200594|NCT01370655|P5|Participant Flow|Treament D → Treatment C|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
200595|NCT01370655|P4|Participant Flow|Treatment D → Treatment A|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
200596|NCT01370655|P3|Participant Flow|Treatment A → Treatment D|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
200597|NCT01370655|P2|Participant Flow|Treatment C → Treatment A|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
200598|NCT01370655|P1|Participant Flow|Treatment A → Treatment C|Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
200599|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
200600|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
200601|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
200602|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
200603|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
200613|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
200614|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
200615|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
200616|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
200617|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
200618|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
200619|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
200620|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
200621|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
200622|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
200623|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
200624|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
200625|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
200626|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
200627|NCT01370655|E4|Reported Event|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
200628|NCT01370655|E3|Reported Event|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
200629|NCT01370655|E2|Reported Event|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
200630|NCT01370655|E1|Reported Event|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
200631|NCT01370642|B4|Baseline|Total|Total of all reporting groups
200632|NCT01370642|B3|Baseline|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
200633|NCT01370642|B2|Baseline|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
200634|NCT01370642|B1|Baseline|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
200635|NCT01370642|P3|Participant Flow|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
200636|NCT01370642|P2|Participant Flow|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
200637|NCT01370642|P1|Participant Flow|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
200638|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
200639|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
200640|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
200641|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
200642|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
200643|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
200644|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
200645|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
200646|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
200647|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
200648|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
200649|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
200650|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
200651|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
200652|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
200653|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
200654|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
200655|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
200656|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
200657|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
200658|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
200659|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
200660|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
200661|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
200662|NCT01370642|E3|Reported Event|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
200663|NCT01370642|E2|Reported Event|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
200664|NCT01370642|E1|Reported Event|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
200665|NCT01370616|B3|Baseline|Total|Total of all reporting groups
200666|NCT01370616|B2|Baseline|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200667|NCT01370616|B1|Baseline|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200668|NCT01370616|P2|Participant Flow|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200669|NCT01370616|P1|Participant Flow|Ertapenem Sodium|Participants received 1.0 g intravenous (IV) ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200670|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200671|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200672|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200673|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200674|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200675|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200676|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200677|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200678|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200679|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200680|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200714|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with
atorvastatin 20 mg once daily for 6 weeks"
200681|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200682|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200683|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200684|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200685|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200686|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200687|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200688|NCT01370616|E2|Reported Event|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200689|NCT01370616|E1|Reported Event|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
200690|NCT01370603|B3|Baseline|Total|Total of all reporting groups
200691|NCT01370603|B2|Baseline|Combination/Co-administration Sequence|Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg
200692|NCT01370603|B1|Baseline|Co-administration/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination
200693|NCT01370603|P2|Participant Flow|Combination/Co-administration Sequence|Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg
200694|NCT01370603|P1|Participant Flow|Co-administration/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination
200695|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
200696|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
200697|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
200698|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
200699|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
200700|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
200701|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
200702|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
200703|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
200704|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
200705|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
200706|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
200707|NCT01370603|E2|Reported Event|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 20 mg once daily for 6 weeks
200708|NCT01370603|E1|Reported Event|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
200709|NCT01370590|B3|Baseline|Total|Total of all reporting groups
200710|NCT01370590|B2|Baseline|Combination/Coadministered Sequence|Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg
200711|NCT01370590|B1|Baseline|Coadministered/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg then Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination
200712|NCT01370590|P2|Participant Flow|Combination/Coadministered Sequence|Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg
200713|NCT01370590|P1|Participant Flow|Coadministered/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg then Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination
200715|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
200716|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with
atorvastatin 20 mg once daily for 6 weeks"
200717|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
200718|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with
atorvastatin 20 mg once daily for 6 weeks"
200719|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
200720|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with
atorvastatin 20 mg once daily for 6 weeks"
200721|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
200722|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with
atorvastatin 20 mg once daily for 6 weeks"
200723|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
200724|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with
atorvastatin 20 mg once daily for 6 weeks"
200725|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
200726|NCT01370590|E2|Reported Event|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with
atorvastatin 20 mg once daily for 6 weeks"
200727|NCT01370590|E1|Reported Event|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
200728|NCT01370538|B3|Baseline|Total|Total of all reporting groups
200729|NCT01370538|B2|Baseline|Placebo|Placebo for Esomeprazole
200730|NCT01370538|B1|Baseline|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200731|NCT01370538|P2|Participant Flow|Placebo|Placebo for Esomeprazole
200732|NCT01370538|P1|Participant Flow|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200733|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
200734|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200735|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
200736|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200737|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
200738|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200739|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
200740|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200741|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
200742|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200743|NCT01370538|E2|Reported Event|Placebo|Placebo for Esomeprazole
200744|NCT01370538|E1|Reported Event|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200745|NCT01370525|B3|Baseline|Total|Total of all reporting groups
200746|NCT01370525|B2|Baseline|Placebo|Placebo for Esomeprazole
200747|NCT01370525|B1|Baseline|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200748|NCT01370525|P2|Participant Flow|Placebo|Placebo for Esomeprazole
200749|NCT01370525|P1|Participant Flow|Esomeprazole|Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate
200750|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
200751|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200752|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
200753|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200754|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
200755|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200756|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
200757|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200758|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
200759|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200760|NCT01370525|E2|Reported Event|Placebo|Placebo for Esomeprazole
200761|NCT01370525|E1|Reported Event|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
200762|NCT01370460|B3|Baseline|Total|Total of all reporting groups
200763|NCT01370460|B2|Baseline|Placebo|100mL 0.9% NS, applied topically
200764|NCT01370460|B1|Baseline|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
200765|NCT01370460|P2|Participant Flow|Placebo|100mL 0.9% NS, applied topically
200766|NCT01370460|P1|Participant Flow|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
200767|NCT01370460|O2|Outcome|Placebo|100mL 0.9% NS, applied topically
200768|NCT01370460|O1|Outcome|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
200769|NCT01370460|O2|Outcome|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
200770|NCT01370460|O1|Outcome|Placebo|100mL 0.9% NS, applied topically
200771|NCT01370460|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
200772|NCT01370408|B1|Baseline|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
200812|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200773|NCT01370408|P1|Participant Flow|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
200774|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
200775|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
200776|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
200777|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
200778|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
200779|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
200780|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
200781|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
200782|NCT01370408|E1|Reported Event|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
200783|NCT01370369|B1|Baseline|Testosterone Topical|"For single dose PKs, a single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the inner thigh followed by a 7-day washout period. After this washout period, the second single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the abdomen followed by another 7-day washout period. After this washout period, the third single application of 2.50 mL (2 strokes) of the testosterone gel 2% was applied to the shoulder/upper arm.
After the last 24 hour PK sampling from the shoulder/upper arm, 3 ascending doses of testosterone gel 2%, 1.25, 2.50 and 3.75 mL (1 stroke, 2 strokes and 3 strokes, respectively), were sequentially applied once daily for 10 consecutive days to the shoulder/upper arm. Steady-state PK evaluations were performed starting on the morning of the last administered dose. There was no washout between each of the 10-day treatments."
200813|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
201040|NCT01369745|E2|Reported Event|Dipyridamole|dipyridamole 360 mg once daily
200784|NCT01370369|P1|Participant Flow|Testosterone Topical|"For single dose pharmacokinetics (PKs), a single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the inner thigh followed by a 7-day washout period. After this washout period, the second single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the abdomen followed by another 7-day washout period. After this washout period, the third single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the shoulder/upper arm.
After the last 24 hour PK sampling from the shoulder/upper arm, three ascending doses of testosterone gel 2%, 1.25, 2.50 and 3.75 mL (one stroke, two strokes and three strokes, respectively), were sequentially applied once daily for 10 consecutive days to the shoulder/upper arm. Steady-state PK evaluations were performed starting on the morning of the last administered dose. There was no washout between each of the 10-day treatments."
200785|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200786|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200787|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200788|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200789|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200790|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200791|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200792|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200793|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200794|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200795|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200796|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200797|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200798|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200799|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200800|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200801|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200802|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200803|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200804|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200805|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200806|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200807|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200808|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200809|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200810|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200811|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (One stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200814|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200815|NCT01370369|O3|Outcome|Single Testosterone Dose (Shoulder/Upper Arm)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm.
200816|NCT01370369|O2|Outcome|Single Testosterone Dose (Abdomen)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a 7-day washout period.
200817|NCT01370369|O1|Outcome|Single Testosterone Dose (Inner Thigh)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a 7-day washout period.
200818|NCT01370369|O3|Outcome|Single Testosterone Dose (Shoulder/Upper Arm)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm.
200819|NCT01370369|O2|Outcome|Single Testosterone Dose (Abdomen)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen thigh followed by a seven day washout period.
200820|NCT01370369|O1|Outcome|Single Testosterone Dose (Inner Thigh)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a 7-day washout period.
200821|NCT01370369|O3|Outcome|Single Testosterone Dose (Shoulder/Upper Arm)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm.
200822|NCT01370369|O2|Outcome|Single Testosterone Dose (Abdomen)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a 7-day washout period.
200823|NCT01370369|O1|Outcome|Single Testosterone Dose (Inner Thigh)|Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a 7-day washout period.
200824|NCT01370369|O3|Outcome|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200825|NCT01370369|O2|Outcome|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200826|NCT01370369|O1|Outcome|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200827|NCT01370369|E3|Reported Event|Testosterone 3.75|Subjects received testosterone gel 2% at dose of 3.75 mL (3 strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200828|NCT01370369|E2|Reported Event|Testosterone 2.50|Subjects received testosterone gel 2% at dose of 2.50 mL (2 strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200829|NCT01370369|E1|Reported Event|Testosterone 1.25|Subjects received testosterone gel 2% at dose of 1.25 mL (1 stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
200830|NCT01370356|B3|Baseline|Total|Total of all reporting groups
200831|NCT01370356|B2|Baseline|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population.
200832|NCT01370356|B1|Baseline|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. One participant was assigned to varenicline as a male but is in fact female. Data below are presented for the treated population.
200833|NCT01370356|P2|Participant Flow|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population.
200834|NCT01370356|P1|Participant Flow|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg twice daily [BID]). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. Data below are presented for the treated population.
200835|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
200836|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
200837|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
200838|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
200839|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
200840|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
200841|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
200842|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
200888|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200843|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
200844|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
200845|NCT01370356|E2|Reported Event|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
200846|NCT01370356|E1|Reported Event|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
200847|NCT01370265|B1|Baseline|Entire Study Population|Includes groups randomized to receive Regadenoson first and Adenosine first.
200848|NCT01370265|P2|Participant Flow|Adenosine, Then Regadenoson|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the first intervention period. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered. After a washout period, Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the second intervention period.
200849|NCT01370265|P1|Participant Flow|Regadenoson, Then Adenosine|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the first intervention period. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the second intervention period (after washout period). Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
200850|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
200851|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
200852|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
200853|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
200854|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
200855|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
200856|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
200857|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
200858|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
200859|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
200860|NCT01370265|O1|Outcome|Entire Study Population|Includes groups randomized to receive Regadenoson first and Adenosine first.
200861|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
200862|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
200863|NCT01370265|E2|Reported Event|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
200864|NCT01370265|E1|Reported Event|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
200865|NCT01370083|B3|Baseline|Total|Total of all reporting groups
200866|NCT01370083|B2|Baseline|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
200867|NCT01370083|B1|Baseline|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
200889|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200890|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200891|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200892|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200868|NCT01370083|P2|Participant Flow|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
200869|NCT01370083|P1|Participant Flow|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
200870|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
200871|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
200872|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
200873|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
200874|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
200875|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
200876|NCT01370083|E2|Reported Event|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
200877|NCT01370083|E1|Reported Event|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
200878|NCT01370005|B4|Baseline|Total|Total of all reporting groups
200879|NCT01370005|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200880|NCT01370005|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200881|NCT01370005|B1|Baseline|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200882|NCT01370005|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200883|NCT01370005|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200884|NCT01370005|P1|Participant Flow|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200885|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200886|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200887|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
201034|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
200893|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200894|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200895|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200896|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200897|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200898|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200899|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200900|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200901|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200902|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200903|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200904|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200905|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200906|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200907|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200908|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200909|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200910|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200911|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200912|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200913|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200914|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200915|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200916|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200917|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200918|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200919|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200920|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200921|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200922|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200923|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200924|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200925|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200926|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200927|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200928|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200929|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200930|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200931|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200932|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200933|NCT01370005|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
200934|NCT01370005|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
200935|NCT01370005|E1|Reported Event|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
200936|NCT01369888|B5|Baseline|Total|Total of all reporting groups
200937|NCT01369888|B4|Baseline|IL-15 Following Young TIL (2 mcg)|"2 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200938|NCT01369888|B3|Baseline|IL-15 Following Young TIL (10.50 mcg)|"1 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
201035|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
201036|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
201037|NCT01369745|E5|Reported Event|Placebo|placebo once daily
201038|NCT01369745|E4|Reported Event|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
200939|NCT01369888|B2|Baseline|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200940|NCT01369888|B1|Baseline|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200941|NCT01369888|P4|Participant Flow|IL-15 Following Young TIL (2 mcg)|"2 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200942|NCT01369888|P3|Participant Flow|IL-15 Following Young TIL (1 mcg)|"1 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200943|NCT01369888|P2|Participant Flow|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200944|NCT01369888|P1|Participant Flow|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200945|NCT01369888|O2|Outcome|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200946|NCT01369888|O1|Outcome|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200947|NCT01369888|O2|Outcome|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200948|NCT01369888|O1|Outcome|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200949|NCT01369888|E2|Reported Event|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200950|NCT01369888|E1|Reported Event|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10
Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days
Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0
IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
200951|NCT01369875|B3|Baseline|Total|Total of all reporting groups
200952|NCT01369875|B2|Baseline|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0
Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)
Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)
Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
200953|NCT01369875|B1|Baseline|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0
Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)
Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
200954|NCT01369875|P2|Participant Flow|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0
Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)
Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)
Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
200955|NCT01369875|P1|Participant Flow|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0
Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)
Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
200956|NCT01369875|O2|Outcome|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0
Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)
Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)
Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
200957|NCT01369875|O1|Outcome|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0
Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)
Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
200958|NCT01369875|O2|Outcome|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0
Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)
Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)
Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
200959|NCT01369875|O1|Outcome|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0
Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)
Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
200960|NCT01369875|E2|Reported Event|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0
Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)
Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)
Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
200961|NCT01369875|E1|Reported Event|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0
Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)
Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
200962|NCT01369849|B4|Baseline|Total|Total of all reporting groups
200963|NCT01369849|B3|Baseline|Phase II|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200964|NCT01369849|B2|Baseline|Phase I: Dose Level 2|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200965|NCT01369849|B1|Baseline|Phase I: Dose Level 1|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200966|NCT01369849|P3|Participant Flow|Phase II|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200967|NCT01369849|P2|Participant Flow|Phase I: Dose Level 2|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200968|NCT01369849|P1|Participant Flow|Phase I: Dose Level 1|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200969|NCT01369849|O1|Outcome|Dose Level 1|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200970|NCT01369849|O3|Outcome|Phase II|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200971|NCT01369849|O2|Outcome|Phase I: Dose Level 2|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200972|NCT01369849|O1|Outcome|Phase I: Dose Level 1|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200973|NCT01369849|E3|Reported Event|Phase II|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200974|NCT01369849|E2|Reported Event|Phase I: Dose Level 2|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200975|NCT01369849|E1|Reported Event|Phase I: Dose Level 1|"Patients receive:
Cycle 1:
Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
Rituximab IV 375 mg/m^2 on day 8.
Bendamustine IV 70 mg/m^2 on day 8 and 9.
Cycles 2-6:
Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
Rituximab IV 500 mg/m^2 on day 1.
Bendamustine IV 70 mg/m^2 on day 1 and 2."
200976|NCT01369784|B1|Baseline|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200977|NCT01369784|P1|Participant Flow|Refractory/Relapsed LDCBG (Diffuse Large-B-cell Lymphoma)|patients with refractory/relapsed diffuse large B-cell lymphoma
200978|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200979|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200980|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200981|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200982|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200983|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200984|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200985|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200986|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200987|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200988|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200989|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200990|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200991|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200992|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200993|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200994|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200995|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200996|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200997|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200998|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
200999|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
201000|NCT01369784|E1|Reported Event|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
201001|NCT01369745|B6|Baseline|Total|Total of all reporting groups
201002|NCT01369745|B5|Baseline|Placebo|placebo once daily
201003|NCT01369745|B4|Baseline|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily The trial would progress from Stage 3 to Stage 5 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
201004|NCT01369745|B3|Baseline|Prednisone|Prednisone 5 mg once daily The trial would progress from Stage 2 to Stage 4 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
201005|NCT01369745|B2|Baseline|Dipyridamole|dipyridamole 360 mg once daily The trial would progress from Stage 2 to Stage 3 if the posterior probability that Z102 is superior to dipyridamole was greater than 0.975.
201006|NCT01369745|B1|Baseline|Prednisolone|Prednisolone 2.7 mg once daily The trial would progress from Stage 1 to Stage 2 if the posterior probability that Z102 is superior to placebo was greater than 0.975.
201007|NCT01369745|P5|Participant Flow|Placebo|placebo once daily
201008|NCT01369745|P4|Participant Flow|Z102|2.7 mg prednisolone plus 360 mg dipyridamole once daily
201009|NCT01369745|P3|Participant Flow|Prednisone|Prednisone 5 mg once daily
201010|NCT01369745|P2|Participant Flow|Dipyridamole|dipyridamole 360 mg once daily
201011|NCT01369745|P1|Participant Flow|Prednisolone|Prednisolone 2.7 mg once daily
201012|NCT01369745|O5|Outcome|Placebo|placebo once daily
201013|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
201014|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
201015|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
201016|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
201017|NCT01369745|O5|Outcome|Placebo|placebo once daily
201018|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
201019|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
201020|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
201021|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
201022|NCT01369745|O5|Outcome|Placebo|placebo once daily
201023|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
201024|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
201025|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
201026|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
201027|NCT01369745|O5|Outcome|Placebo|placebo once daily
201028|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
201029|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
201030|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
201031|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
201032|NCT01369745|O5|Outcome|Placebo|placebo once daily
201033|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
201041|NCT01369745|E1|Reported Event|Prednisolone|Prednisolone 2.7 mg daily
201042|NCT01369732|B3|Baseline|Total|Total of all reporting groups
201043|NCT01369732|B2|Baseline|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
201044|NCT01369732|B1|Baseline|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
201045|NCT01369732|P2|Participant Flow|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
201046|NCT01369732|P1|Participant Flow|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
201047|NCT01369732|O2|Outcome|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
201048|NCT01369732|O1|Outcome|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
201049|NCT01369732|E2|Reported Event|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
201050|NCT01369732|E1|Reported Event|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
201051|NCT01369706|B1|Baseline|Hand-held Metal Detector|"Exposure to two hand-held metal detectors
Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
201052|NCT01369706|P1|Participant Flow|Hand-held Metal Detector|"Exposure to two hand-held metal detectors
Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
201053|NCT01369706|O1|Outcome|Hand-held Metal Detector|"Exposure to two hand-held metal detectors
Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
201054|NCT01369706|E1|Reported Event|Hand-held Metal Detector|"Exposure to two hand-held metal detectors
Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
201055|NCT01369680|B5|Baseline|Total|Total of all reporting groups
201056|NCT01369680|B4|Baseline|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
201057|NCT01369680|B3|Baseline|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
201058|NCT01369680|B2|Baseline|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
201059|NCT01369680|B1|Baseline|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
201060|NCT01369680|P4|Participant Flow|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
201061|NCT01369680|P3|Participant Flow|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
201062|NCT01369680|P2|Participant Flow|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
201063|NCT01369680|P1|Participant Flow|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
201064|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine.
201065|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine.
201066|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine.
201067|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine.
201068|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Subjects treated at 1 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
201069|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Subjects treated at 0.5 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
201070|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Subjects treated at 0.25 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
201071|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
201072|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 1 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
201073|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
201074|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
201075|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine
201076|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 1 mg/kg/dose oral ketamine
201077|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine
201078|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine
201079|NCT01369680|E4|Reported Event|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
201080|NCT01369680|E3|Reported Event|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
201081|NCT01369680|E2|Reported Event|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
201082|NCT01369680|E1|Reported Event|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
201107|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201132|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
201083|NCT01369641|B1|Baseline|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.
Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.
Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.
Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
201084|NCT01369641|P1|Participant Flow|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.
Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.
Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.
Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
201085|NCT01369641|O1|Outcome|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.
Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.
Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.
Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
201086|NCT01369641|E1|Reported Event|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.
Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.
Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.
Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
201087|NCT01369615|B3|Baseline|Total|Total of all reporting groups
201088|NCT01369615|B2|Baseline|≥ 12 to ≤ 16 Years|Children 12 to ≤ 16 years of age
201089|NCT01369615|B1|Baseline|6 to < 12 Years|Children 6 to < 12 years of age
201090|NCT01369615|P2|Participant Flow|≥ 12 to ≤ 16 Years|Although the protocol for study OTR3002 defined the age range as 6 to 17 years inclusive, no patients greater than 16 years of age were included in the study. Therefore the data summaries presented the upper limit of the older age group as ≤ 16 years.
201091|NCT01369615|P1|Participant Flow|6 to < 12 Years|Children 6 to < 12 years of age
201092|NCT01369615|O2|Outcome|≥ 12 to ≤ 16 Years|Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
201093|NCT01369615|O1|Outcome|6 to < 12 Years|Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
201094|NCT01369615|E2|Reported Event|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
201095|NCT01369615|E1|Reported Event|6 to < 12 Years|Children 6 to < 12 years of age
201096|NCT01369485|B3|Baseline|Total|Total of all reporting groups
201097|NCT01369485|B2|Baseline|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201098|NCT01369485|B1|Baseline|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201099|NCT01369485|P2|Participant Flow|Randomized Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.
Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months."
201100|NCT01369485|P1|Participant Flow|Randomized Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.
Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months."
201101|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
201102|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
201103|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201104|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201105|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
201106|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
201108|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201109|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201110|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201111|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201112|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201113|NCT01369485|O4|Outcome|Open Label Sham Treatement Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
201114|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
201115|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201116|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201117|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
201118|NCT01369485|O3|Outcome|Open Label Active Treatment Group.|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
201119|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201120|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201121|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201122|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201123|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201124|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201125|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201126|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201127|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201128|NCT01369485|O3|Outcome|Open Label Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201129|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201130|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201131|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
201133|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201134|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201135|NCT01369485|E4|Reported Event|Open Label Sham Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for up to 9 additional months, one per week during the open label phase."
201136|NCT01369485|E3|Reported Event|Open Label Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for up to 9 additional months, one per week during the open label phase."
201137|NCT01369485|E2|Reported Event|Randomized Sham Treatment Group|"Sham version of (VERV™ System)
Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201138|NCT01369485|E1|Reported Event|Randomized Active Treatment Group|"VERV™ System
(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
201139|NCT01369355|B7|Baseline|Total|Total of all reporting groups
201140|NCT01369355|B6|Baseline|UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance|Participants (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response).
201141|NCT01369355|B5|Baseline|PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response).
201142|NCT01369355|B4|Baseline|Placebo (PBO)-I-Rsp - PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study.
201143|NCT01369355|B3|Baseline|UST-I-Rsp-UST-90 mg Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
201144|NCT01369355|B2|Baseline|UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
201145|NCT01369355|B1|Baseline|Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
201146|NCT01369355|P6|Participant Flow|UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance|Participants (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response).
201147|NCT01369355|P5|Participant Flow|PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response).
201148|NCT01369355|P4|Participant Flow|Placebo (PBO)-I-Rsp - PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study.
201149|NCT01369355|P3|Participant Flow|UST-I-Rsp-UST-90 mg Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
201150|NCT01369355|P2|Participant Flow|UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
201151|NCT01369355|P1|Participant Flow|Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
201152|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
201153|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
201154|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
201155|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
201156|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
201157|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
201158|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
201159|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
201522|NCT01368406|P2|Participant Flow|Treatment as Usual|treatment as usual received by the patients
201160|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
201161|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
201162|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
201163|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
201164|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
201165|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
201166|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
201167|NCT01369355|E9|Reported Event|UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance|Participants (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
201168|NCT01369355|E8|Reported Event|PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
201169|NCT01369355|E7|Reported Event|Placebo (PBO)-I-Rsp PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC; not randomized.
201170|NCT01369355|E6|Reported Event|UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 mg q8 weeks and remained on ustekinumab 90 mg q8w upon loss of response (includes events from the time of loss of response onward).
201171|NCT01369355|E5|Reported Event|UST-I-Rsp-UST 90 mg SC Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 mg q8w (includes events up to the time of loss of response).
201172|NCT01369355|E4|Reported Event|UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 mg q12w and had dose adjustment to Ustekinumab SC 90 mg q8w in the maintenance study (includes events from the time of loss of response onward).
201173|NCT01369355|E3|Reported Event|UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study (includes events up to the time of loss of response).
201174|NCT01369355|E2|Reported Event|UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received placebo SC and had dose adjustment to Ustekinumab SC 90 mg q8w (includes events from the time of loss of response onward).
201175|NCT01369355|E1|Reported Event|Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study (includes events up to the time of loss of response).
201176|NCT01369342|B4|Baseline|Total|Total of all reporting groups
201177|NCT01369342|B3|Baseline|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201178|NCT01369342|B2|Baseline|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201179|NCT01369342|B1|Baseline|Placebo IV|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201180|NCT01369342|P3|Participant Flow|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201181|NCT01369342|P2|Participant Flow|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201182|NCT01369342|P1|Participant Flow|Placebo IV|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201183|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201184|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201185|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201186|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201187|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201188|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201189|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201190|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201191|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201192|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201193|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201194|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201195|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201196|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201197|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201198|NCT01369342|E3|Reported Event|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants received a single tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201199|NCT01369342|E2|Reported Event|Ustekinumab 130 Milligram (mg)|Participants received single dose of ustekinumab 130 milligram (mg) IV at week 0.
201200|NCT01369342|E1|Reported Event|Placebo IV|Participants received single dose of Placebo Intravenous (IV) infusion at week 0.
201201|NCT01369329|B4|Baseline|Total|Total of all reporting groups
201202|NCT01369329|B3|Baseline|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201203|NCT01369329|B2|Baseline|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201204|NCT01369329|B1|Baseline|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201205|NCT01369329|P3|Participant Flow|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201206|NCT01369329|P2|Participant Flow|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201207|NCT01369329|P1|Participant Flow|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201208|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201209|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201210|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201211|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201212|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201213|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201214|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201215|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201216|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201217|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201218|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201219|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201350|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
201220|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201221|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201222|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
201223|NCT01369329|E3|Reported Event|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants received tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
201224|NCT01369329|E2|Reported Event|Ustekinumab 130 Milligram (mg)|Participants received a single dose of ustekinumab 130 milligram (mg) IV at week 0.
201225|NCT01369329|E1|Reported Event|Placebo|Participants received a single dose of Placebo Intravenous (IV) infusion at week 0.
201226|NCT01369225|B7|Baseline|Total|Total of all reporting groups
201227|NCT01369225|B6|Baseline|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201228|NCT01369225|B5|Baseline|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201229|NCT01369225|B4|Baseline|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201230|NCT01369225|B3|Baseline|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201231|NCT01369225|B2|Baseline|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201232|NCT01369225|B1|Baseline|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201233|NCT01369225|P6|Participant Flow|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201234|NCT01369225|P5|Participant Flow|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201235|NCT01369225|P4|Participant Flow|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201236|NCT01369225|P3|Participant Flow|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201237|NCT01369225|P2|Participant Flow|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201238|NCT01369225|P1|Participant Flow|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201239|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201240|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201241|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201242|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201243|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201244|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201245|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201246|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201247|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201248|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201249|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201250|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201351|NCT01368900|O1|Outcome|Subjects Treated|All study subject received an Ulthera treatment to the upper face.
201251|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201252|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201253|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201254|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201255|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201256|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201257|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201258|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201259|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201260|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201261|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201262|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201263|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201264|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201265|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201266|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201267|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201268|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201269|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201270|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201271|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201272|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201273|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201274|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201275|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201276|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201277|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201278|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201279|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201280|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201352|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
201281|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201282|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201283|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201284|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201285|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201286|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201287|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201288|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201289|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201290|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201291|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201292|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201293|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201294|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201295|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201296|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201297|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201298|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201299|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201300|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201301|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201302|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201303|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201304|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201305|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201306|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201307|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201308|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201309|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201310|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201353|NCT01368900|E1|Reported Event|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
201354|NCT01368874|B4|Baseline|Total|Total of all reporting groups
201311|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201312|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201313|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201314|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201315|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201316|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201317|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201318|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201319|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201320|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201321|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201322|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201323|NCT01369225|E6|Reported Event|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
201324|NCT01369225|E5|Reported Event|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
201325|NCT01369225|E4|Reported Event|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
201326|NCT01369225|E3|Reported Event|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
201327|NCT01369225|E2|Reported Event|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
201328|NCT01369225|E1|Reported Event|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
201329|NCT01369030|B1|Baseline|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
201330|NCT01369030|P1|Participant Flow|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
201331|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
201332|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
201333|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
201334|NCT01369030|E1|Reported Event|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
201335|NCT01368965|B1|Baseline|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
201336|NCT01368965|P1|Participant Flow|Treated Subjects|All treated study subjects received a full face Ulthera® treatment.
201337|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52).
201338|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
201339|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
201340|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
201341|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
201342|NCT01368965|O1|Outcome|Treated Subjects|All treated study subjects received a full face Ulthera® treatment.
201343|NCT01368965|E1|Reported Event|Enrolled Subjects|Includes all subjects enrolled, including 52 treated subjects and 2 non-treated subjects who withdrew consent prior to treatment.
201344|NCT01368900|B1|Baseline|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
201345|NCT01368900|P1|Participant Flow|Treated Subjects|"The FWCS, a 9 point scale used to classify wrinkle severity, was used to qualify subjects for study participation.
Score 1-3 = Fine wrinkles; 4-6 = Fine to moderate-depth wrinkles, moderate number of lines; 7-9 = Fine to deep wrinkles, Numerous lines with or without redundant skin folds.
All study subjects received an Ulthera treatment to the upper face."
201346|NCT01368900|O1|Outcome|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
201347|NCT01368900|O1|Outcome|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
201348|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
201349|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
201355|NCT01368874|B3|Baseline|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
201356|NCT01368874|B2|Baseline|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
201357|NCT01368874|B1|Baseline|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
201358|NCT01368874|P3|Participant Flow|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
201359|NCT01368874|P2|Participant Flow|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
201360|NCT01368874|P1|Participant Flow|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
201361|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
201362|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
201363|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
201364|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region.
201365|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 180 day post-treatment visit.
201366|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
201367|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
201368|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
201369|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
201370|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 90 day post-treatment visit.
201371|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
201372|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
201373|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
201374|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
201375|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 60 day post-treatment visit.
201376|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 180-day study visit.
201377|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 180-day study visit.
201378|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 180-day study visit.
201379|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 180-day study visit.
201380|NCT01368874|O1|Outcome|All Subjects Treated|Sixty (60) of 64 treated participants completed the 180-day study visit.
201381|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 90-day study visit.
201382|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 90-day study visit.
201383|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 90-day study visit.
201384|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) participants completed the 90-day study visit.
201385|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit.
201386|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 180-day study visit.
201387|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 180-day study visit.
201388|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the study visit.
201389|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 180-day study visit.
201390|NCT01368874|O1|Outcome|All Subjects Treated|Sixty(60) of 64 treated participants completed the 180-day study visit.
201391|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
204065|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
201392|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
201393|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
201394|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-four 64) treated participants' assessment of pain was completed during the Ulthera® treatment.
201395|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular, and lower neck regions.
201396|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions.
201397|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental,submandibular,and lower neck regions.
201398|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region.
201399|NCT01368874|O1|Outcome|All Subjects Treated|A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.
201400|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 90-day study visit.
201401|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four(24) participants completed the 90-day study visit.
201402|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 90-day study visit.
201403|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) participants completed the 90-day study visit.
201404|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit.
201405|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Thirty (30) participants completed the 60-day study visit.
201406|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-five (25) participants completed the 60-day study visit.
201407|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 60-day study visit.
201408|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 60-day study visit.
201409|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 60- visit.
201410|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
201411|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up
201412|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.
201413|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.
201414|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.
201415|NCT01368874|E4|Reported Event|Groups B/C|
201416|NCT01368874|E3|Reported Event|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
201417|NCT01368874|E2|Reported Event|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
201418|NCT01368874|E1|Reported Event|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
201419|NCT01368835|B1|Baseline|Ulthera Treatment|Treatment to the lower face and submental region.
201420|NCT01368835|P1|Participant Flow|Ulthera Treatment|Subjects will receive one dual-depth focused ultrasound treatment to their lower face and submental regions.
201421|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
201422|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
201423|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
201424|NCT01368835|O1|Outcome|Ulthera Treatment|Subjects who received one focused ultrasound treatment to the lower face and submental regions using the Ultera System.
201425|NCT01368835|E1|Reported Event|Ulthera Treatment|Treatment to the lower face and submental region.
201426|NCT01368809|B3|Baseline|Total|Total of all reporting groups
201427|NCT01368809|B2|Baseline|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed
Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
201428|NCT01368809|B1|Baseline|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
Saline: 2 ml at induction 1-2 ml boluses as needed"
201429|NCT01368809|P2|Participant Flow|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
201430|NCT01368809|P1|Participant Flow|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
201431|NCT01368809|O2|Outcome|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
201432|NCT01368809|O1|Outcome|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
201433|NCT01368809|O2|Outcome|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
201434|NCT01368809|O1|Outcome|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
201435|NCT01368809|O2|Outcome|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed
Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
201436|NCT01368809|O1|Outcome|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
Saline: 2 ml at induction 1-2 ml boluses as needed"
201437|NCT01368809|E2|Reported Event|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed
Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
201438|NCT01368809|E1|Reported Event|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
Saline: 2 ml at induction 1-2 ml boluses as needed"
201439|NCT01368653|B3|Baseline|Total|Total of all reporting groups
201440|NCT01368653|B2|Baseline|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
201441|NCT01368653|B1|Baseline|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
201442|NCT01368653|P2|Participant Flow|Standard Treatment+Practice Quitting|"In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
201443|NCT01368653|P1|Participant Flow|Standard Treatment|"In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
201444|NCT01368653|O4|Outcome|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
201445|NCT01368653|O3|Outcome|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
201446|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
201447|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
201448|NCT01368653|O4|Outcome|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
201462|NCT01368536|P3|Participant Flow|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
201521|NCT01368406|B1|Baseline|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
201449|NCT01368653|O3|Outcome|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
201450|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
201451|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
201452|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
201453|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
201454|NCT01368653|E4|Reported Event|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
201455|NCT01368653|E3|Reported Event|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
201456|NCT01368653|E2|Reported Event|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
201457|NCT01368653|E1|Reported Event|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
201458|NCT01368536|B4|Baseline|Total|Total of all reporting groups
201459|NCT01368536|B3|Baseline|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
201460|NCT01368536|B2|Baseline|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
201461|NCT01368536|B1|Baseline|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
201516|NCT01368432|O1|Outcome|Placebo Group Baseline|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
201517|NCT01368432|E2|Reported Event|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week.
201463|NCT01368536|P2|Participant Flow|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
201464|NCT01368536|P1|Participant Flow|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
201465|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
201466|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
201467|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
201468|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
201469|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
201470|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
201471|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
201472|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
201473|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
201474|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
201475|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
201476|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
201477|NCT01368536|O2|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
201478|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
201518|NCT01368432|E1|Reported Event|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
201519|NCT01368406|B3|Baseline|Total|Total of all reporting groups
201520|NCT01368406|B2|Baseline|Treatment as Usual|treatment as usual received by the patients
201479|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
201480|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
201481|NCT01368536|E3|Reported Event|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
201482|NCT01368536|E2|Reported Event|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
201483|NCT01368536|E1|Reported Event|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
201484|NCT01368432|B3|Baseline|Total|Total of all reporting groups
201485|NCT01368432|B2|Baseline|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
201486|NCT01368432|B1|Baseline|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
201487|NCT01368432|P2|Participant Flow|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
201488|NCT01368432|P1|Participant Flow|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
201489|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
201490|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
201491|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
201492|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
201493|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
201494|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
201495|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
201496|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
201497|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
201498|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
201499|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
201500|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
201501|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
201502|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
201503|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
201504|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
201505|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention and represents their anxiety score.
201506|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention and represents their anxiety score.
201507|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention and represents their anxiety score.
201508|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention and represents their anxiety score.
201509|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram and represents their global health at 12 weeks.
201510|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention and represents their global health score at 12 weeks
201511|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram and represents their baseline global health
201512|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention and represents their baseline global health.
201513|NCT01368432|O2|Outcome|Treatment Group MADRS 12 Weeks|This group consists of participants who received escitalopram and their level of depression as assessed by the MADRS scoring system.
201514|NCT01368432|O1|Outcome|Placebo Group MADRS 12 Weeks|This group consists of participants who received the placebo intervention and their level of depression as assessed by the MADRS scoring system.
201515|NCT01368432|O2|Outcome|Treatment Group Baseline|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
201523|NCT01368406|P1|Participant Flow|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
201524|NCT01368406|O2|Outcome|Treatment as Usual|treatment as usual received by the patients
201525|NCT01368406|O1|Outcome|Wellness Program|lifestyle intervention for 12 weeks
201526|NCT01368406|E2|Reported Event|Treatment as Usual|treatment as usual received by the patients
201527|NCT01368406|E1|Reported Event|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
201528|NCT01368276|B3|Baseline|Total|Total of all reporting groups
201529|NCT01368276|B2|Baseline|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201530|NCT01368276|B1|Baseline|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201531|NCT01368276|P2|Participant Flow|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201532|NCT01368276|P1|Participant Flow|GM-CSF|Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201533|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201534|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201535|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201536|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201537|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201538|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201539|NCT01368276|E2|Reported Event|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201581|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
202640|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
201540|NCT01368276|E1|Reported Event|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
201541|NCT01368263|B4|Baseline|Total|Total of all reporting groups
201542|NCT01368263|B3|Baseline|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201543|NCT01368263|B2|Baseline|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201544|NCT01368263|B1|Baseline|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
201545|NCT01368263|P3|Participant Flow|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201546|NCT01368263|P2|Participant Flow|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201547|NCT01368263|P1|Participant Flow|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
201548|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201549|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201550|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
201551|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201552|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201553|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
201554|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201555|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201556|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
201557|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201558|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201559|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
201560|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201561|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201562|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
201563|NCT01368263|E3|Reported Event|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201564|NCT01368263|E2|Reported Event|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
201565|NCT01368263|E1|Reported Event|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
201566|NCT01368211|B3|Baseline|Total|Total of all reporting groups
201567|NCT01368211|B2|Baseline|Reference First, Then Mirasol|"This study arm will receive first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).
Mirasol-treated Platelets: Mirasol-treated platelet units with:
Platelet yield between 2.4x10e11 and 4.5x10e11
Plasma carryover of >32%
Cell count > 800x103/µL"
201568|NCT01368211|B1|Baseline|Mirasol First, Then Reference|"This study arm will receive first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).
Mirasol-treated Platelets: Mirasol-treated platelet units with:
Platelet yield between 2.4x10e11 and 4.5x10e11
Plasma carryover of >32%
Cell count > 800x103/µL"
201569|NCT01368211|P2|Participant Flow|Reference First, Then Mirasol|"This study arm received first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).
Mirasol-treated Platelets: Mirasol-treated platelet units with:
Platelet yield between 2.4x10e11 and 4.5x10e11
Plasma carryover of >32%
Cell count > 800x103/µL"
201570|NCT01368211|P1|Participant Flow|Mirasol First, Then Reference|"This study arm received first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).
Mirasol-treated Platelets: Mirasol-treated platelet units with:
Platelet yield between 2.4x10e11 and 4.5x10e11
Plasma carryover of >32%
Cell count > 800x103/µL"
201571|NCT01368211|O2|Outcome|Untreated Reference|Untreated 2-4-day old platelet transfusion
201572|NCT01368211|O1|Outcome|Mirasol|Mirasol-treated 2-4-day old platelet transfusion
201573|NCT01368211|O2|Outcome|Untreated Reference|Untreated 2-4-day old platelet transfusion
201574|NCT01368211|O1|Outcome|Mirasol|Mirasol-treated 2-4-day old platelet transfusion
201575|NCT01368211|E2|Reported Event|Untreated Reference Platelets|Patients that received an untreated reference2-4-day-old platelet transfusion.
201576|NCT01368211|E1|Reported Event|Mirasol-treated Platelets|Patients that received a Mirasol treated 2-4-day-old platelet transfusion.
201577|NCT01368185|B1|Baseline|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
201578|NCT01368185|P1|Participant Flow|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
201579|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
201580|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
201582|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
201583|NCT01368185|E1|Reported Event|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
201584|NCT01368081|B14|Baseline|Total|Total of all reporting groups
201585|NCT01368081|B13|Baseline|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
201586|NCT01368081|B12|Baseline|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
201587|NCT01368081|B11|Baseline|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
201588|NCT01368081|B10|Baseline|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
201589|NCT01368081|B9|Baseline|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
201590|NCT01368081|B8|Baseline|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
201591|NCT01368081|B7|Baseline|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201592|NCT01368081|B6|Baseline|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201593|NCT01368081|B5|Baseline|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201594|NCT01368081|B4|Baseline|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201595|NCT01368081|B3|Baseline|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
201596|NCT01368081|B2|Baseline|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201597|NCT01368081|B1|Baseline|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201598|NCT01368081|P13|Participant Flow|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
201599|NCT01368081|P12|Participant Flow|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
201600|NCT01368081|P11|Participant Flow|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor
201601|NCT01368081|P10|Participant Flow|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor
201602|NCT01368081|P9|Participant Flow|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
201603|NCT01368081|P8|Participant Flow|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
201604|NCT01368081|P7|Participant Flow|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201605|NCT01368081|P6|Participant Flow|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201606|NCT01368081|P5|Participant Flow|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201607|NCT01368081|P4|Participant Flow|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201608|NCT01368081|P3|Participant Flow|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
201609|NCT01368081|P2|Participant Flow|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201610|NCT01368081|P1|Participant Flow|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201611|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
201612|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
201613|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
201614|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
201615|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
201616|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
201617|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201618|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201619|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201620|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201621|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
201622|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201623|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201624|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
201625|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
201626|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
201627|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
201628|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
201629|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
201630|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201631|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201632|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201633|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201634|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
201635|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201636|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201637|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
201638|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
201639|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
201640|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
201641|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
201642|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
201643|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201644|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201645|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201646|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201647|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
201648|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201649|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201650|NCT01368081|E13|Reported Event|Glinide: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
201651|NCT01368081|E12|Reported Event|Glinide: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
202237|NCT01366209|P1|Participant Flow|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
201652|NCT01368081|E11|Reported Event|DPP-4 Inhibitor: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
201653|NCT01368081|E10|Reported Event|DPP-4 Inhibitor: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
201654|NCT01368081|E9|Reported Event|Alpha-GI: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
201655|NCT01368081|E8|Reported Event|Alpha-GI: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
201656|NCT01368081|E7|Reported Event|Thiazolidinedione: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201657|NCT01368081|E6|Reported Event|Thiazolidinedione: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
201658|NCT01368081|E5|Reported Event|Biguanide: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201659|NCT01368081|E4|Reported Event|Biguanide: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
201660|NCT01368081|E3|Reported Event|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
201661|NCT01368081|E2|Reported Event|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201662|NCT01368081|E1|Reported Event|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
201663|NCT01368042|B1|Baseline|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201664|NCT01368042|P1|Participant Flow|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201665|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201666|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201667|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201668|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201669|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201670|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201671|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201672|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201673|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201674|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201675|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201676|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201677|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201678|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201679|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201680|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201681|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201682|NCT01368042|E1|Reported Event|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible patients treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
201683|NCT01367886|B1|Baseline|Fesoterodine|Overactive bladder subjects took Fesoterodine 4 mg daily for 6 weeks.
201684|NCT01367886|P1|Participant Flow|Fesoterodine|"Females with overactive bladder symptoms were given Fesoterodine 4 mg. daily for six weeks.
Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
201685|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.
fesoterodine: Fesoterodine 4 mg. tablet by mouth daily for six weeks"
201686|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.
fesoterodine: Fesoterodine 4 mg. tablet by mouth daily for six weeks"
201687|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.
fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
201688|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.
fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
201689|NCT01367886|E1|Reported Event|Fesoterodine|"Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.
Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
201690|NCT01367860|B3|Baseline|Total|Total of all reporting groups
201691|NCT01367860|B2|Baseline|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201692|NCT01367860|B1|Baseline|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201693|NCT01367860|P2|Participant Flow|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201694|NCT01367860|P1|Participant Flow|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201695|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201696|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201697|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201698|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201699|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201700|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201701|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201774|NCT01367457|P2|Participant Flow|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
204066|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
201702|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201703|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201704|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201705|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201706|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201707|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201708|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201709|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201710|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201711|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201712|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201713|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201714|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201715|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201716|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201717|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201718|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201719|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201720|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201721|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201722|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201723|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201724|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201725|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201726|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201727|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201728|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201729|NCT01367860|E2|Reported Event|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
201730|NCT01367860|E1|Reported Event|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
201731|NCT01367834|B3|Baseline|Total|Total of all reporting groups
201732|NCT01367834|B2|Baseline|Control|Subjects will receive no GH or placebo.
201733|NCT01367834|B1|Baseline|Growth Hormone|"Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
201734|NCT01367834|P2|Participant Flow|Control|Subjects will receive no GH or placebo.
201735|NCT01367834|P1|Participant Flow|Growth Hormone|"Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
201736|NCT01367834|O2|Outcome|Control|No intervention
201737|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
201738|NCT01367834|O2|Outcome|Control|No intervention
201739|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
201740|NCT01367834|O2|Outcome|Control|No intervention
201741|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
201742|NCT01367834|O2|Outcome|Control|No intervention
201743|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
201744|NCT01367834|O2|Outcome|Control|No intervention
201745|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
201746|NCT01367834|O2|Outcome|Control|No intervention
201747|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
201748|NCT01367834|O2|Outcome|Control|No intervention
201749|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
201750|NCT01367834|O2|Outcome|Control|No intervention
201751|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
201752|NCT01367834|O2|Outcome|Control|No intervention
201753|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
201754|NCT01367834|E2|Reported Event|Control|Subjects will receive no GH or placebo.
201755|NCT01367834|E1|Reported Event|Growth Hormone|"Subjects in the somatotropin (growth hormone, GH) arm will receive GH injections from 12-24 months of life.
somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
201756|NCT01367704|B3|Baseline|Total|Total of all reporting groups
201757|NCT01367704|B2|Baseline|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)
Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
201758|NCT01367704|B1|Baseline|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
201775|NCT01367457|P1|Participant Flow|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
201776|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
204067|NCT01360021|E3|Reported Event|Symbicort pMDI|
201759|NCT01367704|P2|Participant Flow|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)
Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
201760|NCT01367704|P1|Participant Flow|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
201761|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)
Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
201762|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
201763|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)
Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
201764|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
201765|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)
Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
201766|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
201767|NCT01367704|E2|Reported Event|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)
Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
201768|NCT01367704|E1|Reported Event|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
201769|NCT01367457|B4|Baseline|Total|Total of all reporting groups
201770|NCT01367457|B3|Baseline|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
201771|NCT01367457|B2|Baseline|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
201772|NCT01367457|B1|Baseline|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
201773|NCT01367457|P3|Participant Flow|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
201839|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201777|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
201778|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
201779|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
201780|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
201781|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
201782|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
201783|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
201784|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
201785|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
201786|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
201787|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
201788|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
201789|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
201790|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
201791|NCT01367457|E3|Reported Event|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
201792|NCT01367457|E2|Reported Event|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
201793|NCT01367457|E1|Reported Event|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
201794|NCT01367249|B3|Baseline|Total|Total of all reporting groups
201795|NCT01367249|B2|Baseline|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
201796|NCT01367249|B1|Baseline|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
201797|NCT01367249|P2|Participant Flow|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
201798|NCT01367249|P1|Participant Flow|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
201799|NCT01367249|O2|Outcome|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
201800|NCT01367249|O1|Outcome|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
201801|NCT01367249|O2|Outcome|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
201802|NCT01367249|O1|Outcome|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
201840|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
201803|NCT01367249|E2|Reported Event|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
201804|NCT01367249|E1|Reported Event|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
201805|NCT01367158|B12|Baseline|Total|Total of all reporting groups
201806|NCT01367158|B11|Baseline|1ACWY|One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
201807|NCT01367158|B10|Baseline|2 B|Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
201808|NCT01367158|B9|Baseline|3 B|Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
201809|NCT01367158|B8|Baseline|2ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
201810|NCT01367158|B7|Baseline|3ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
201811|NCT01367158|B6|Baseline|2ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
201812|NCT01367158|B5|Baseline|3ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
201813|NCT01367158|B4|Baseline|2ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
201814|NCT01367158|B3|Baseline|3ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
201815|NCT01367158|B2|Baseline|2ABCWY|Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
201816|NCT01367158|B1|Baseline|3ABCWY|Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
201817|NCT01367158|P11|Participant Flow|1ACWY|One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
201818|NCT01367158|P10|Participant Flow|2 B|Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
201819|NCT01367158|P9|Participant Flow|3 B|Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
201820|NCT01367158|P8|Participant Flow|2ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
201821|NCT01367158|P7|Participant Flow|3ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
201822|NCT01367158|P6|Participant Flow|2ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
201823|NCT01367158|P5|Participant Flow|3ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
201824|NCT01367158|P4|Participant Flow|2ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
201825|NCT01367158|P3|Participant Flow|3ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
201826|NCT01367158|P2|Participant Flow|2ABCWY|Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
201827|NCT01367158|P1|Participant Flow|3ABCWY|Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
201828|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201829|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
201830|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201831|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
201832|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201833|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
201834|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201835|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201836|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201837|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201838|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
202022|NCT01366846|B5|Baseline|Total|Total of all reporting groups
204068|NCT01360021|E2|Reported Event|Symbicort BA MDI|
201841|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201842|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
201843|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201844|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
201845|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201846|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201847|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201848|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201849|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201850|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201851|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
201852|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201853|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
201854|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201855|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
201856|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201857|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201858|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201859|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201860|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201861|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201862|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201863|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201864|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201865|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201866|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201867|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201868|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201869|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201870|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201871|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201872|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201873|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201874|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201875|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201876|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201877|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201878|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201879|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201880|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201881|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201882|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201883|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201884|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201885|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201886|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
201887|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
201888|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
201889|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201890|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201891|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201892|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
201893|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study.
201894|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
202238|NCT01366209|O2|Outcome|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
201895|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201896|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201897|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201898|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
201899|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
201900|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
201901|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201902|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201903|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201904|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
201905|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
201906|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
201907|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201908|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201909|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201910|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201911|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201912|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201913|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201914|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201915|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201916|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201917|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201918|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201919|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201920|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201921|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201922|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201923|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201924|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201925|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201926|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201927|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201928|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201929|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201930|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201931|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201932|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201933|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201934|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201935|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201936|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201937|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201938|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201939|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201940|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201941|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201942|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201943|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201944|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201945|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201946|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201947|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201948|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201949|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
204069|NCT01360021|E1|Reported Event|Budesonide|
201950|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201951|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201952|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201953|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201954|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201955|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201956|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201957|NCT01367158|E11|Reported Event|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
201958|NCT01367158|E10|Reported Event|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
201959|NCT01367158|E9|Reported Event|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
201960|NCT01367158|E8|Reported Event|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
201961|NCT01367158|E7|Reported Event|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
201962|NCT01367158|E6|Reported Event|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
201963|NCT01367158|E5|Reported Event|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
201964|NCT01367158|E4|Reported Event|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201965|NCT01367158|E3|Reported Event|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201966|NCT01367158|E2|Reported Event|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
201967|NCT01367158|E1|Reported Event|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
201968|NCT01367119|B3|Baseline|Total|Total of all reporting groups
201969|NCT01367119|B2|Baseline|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
201970|NCT01367119|B1|Baseline|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
201971|NCT01367119|P2|Participant Flow|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
201972|NCT01367119|P1|Participant Flow|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
201973|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
201974|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
201975|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
201976|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
201977|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
201978|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
201979|NCT01367119|E2|Reported Event|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
201980|NCT01367119|E1|Reported Event|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
201981|NCT01367080|B3|Baseline|Total|Total of all reporting groups
201982|NCT01367080|B2|Baseline|B Group|Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)
201983|NCT01367080|B1|Baseline|A Group|Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)
201984|NCT01367080|P2|Participant Flow|B Group|Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)
201985|NCT01367080|P1|Participant Flow|A Group|Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)
201986|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
201987|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
201988|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
201989|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
201990|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
201991|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
201992|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline hydrochloride 25mg administration Group
201993|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg administration Group
201994|NCT01367080|E2|Reported Event|Etravil 25mg Group|Amitryptyline hydrochloride 25mg administration Group
201995|NCT01367080|E1|Reported Event|Etravil 10mg Group|Amitryptyline hydrochloride 10mg administration Group
201996|NCT01366976|B3|Baseline|Total|Total of all reporting groups
201997|NCT01366976|B2|Baseline|Placebo|Saline in equivalent volume as study drug
201998|NCT01366976|B1|Baseline|Acetaminophen|IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
201999|NCT01366976|P2|Participant Flow|Placebo|Saline in equivalent volume as study drug
202000|NCT01366976|P1|Participant Flow|Acetaminophen|IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
202001|NCT01366976|O2|Outcome|Placebo|Saline infusion
202002|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
202003|NCT01366976|O2|Outcome|Placebo|Saline infusion
202004|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
202005|NCT01366976|O2|Outcome|Placebo|Saline infusion
202006|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
202007|NCT01366976|O2|Outcome|Placebo|Saline infusion
202008|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
202009|NCT01366976|E2|Reported Event|Placebo|Saline infusion
202010|NCT01366976|E1|Reported Event|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
202011|NCT01366885|B1|Baseline|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.
Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
202012|NCT01366885|P1|Participant Flow|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.
Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
202013|NCT01366885|O1|Outcome|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.
Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
202014|NCT01366885|O1|Outcome|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.
Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
202015|NCT01366885|E1|Reported Event|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.
Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
202016|NCT01366872|B1|Baseline|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
202017|NCT01366872|P1|Participant Flow|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
202018|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
202019|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
202020|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
202021|NCT01366872|E1|Reported Event|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
202023|NCT01366846|B4|Baseline|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
202024|NCT01366846|B3|Baseline|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
202025|NCT01366846|B2|Baseline|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
202026|NCT01366846|B1|Baseline|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
202027|NCT01366846|P4|Participant Flow|Positive Stratum – Peanut Avoidance After Peanut Consumption G|Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
202028|NCT01366846|P3|Participant Flow|Positive Stratum – Continued Peanut Avoidance Group|Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
202029|NCT01366846|P2|Participant Flow|Negative Stratum – Peanut Avoidance After Consumption Group|Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
202030|NCT01366846|P1|Participant Flow|Negative Stratum – Continued Peanut Avoidance Group|Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial)
202031|NCT01366846|O1|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
202032|NCT01366846|O1|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
202033|NCT01366846|O2|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
202034|NCT01366846|O1|Outcome|Continued Peanut Avoidance Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation. This group continued to avoid peanut protein throughout LEAP-On (this trial).
202035|NCT01366846|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
202036|NCT01366846|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
202037|NCT01366846|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
202038|NCT01366846|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
202039|NCT01366846|O2|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
202040|NCT01366846|O1|Outcome|Continued Peanut Avoidance Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation. This group continued to avoid peanut protein throughout LEAP-On (this trial).
202041|NCT01366846|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
202042|NCT01366846|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
202043|NCT01366846|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
202044|NCT01366846|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
202045|NCT01366846|E4|Reported Event|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
202046|NCT01366846|E3|Reported Event|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
202047|NCT01366846|E2|Reported Event|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
202048|NCT01366846|E1|Reported Event|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
202049|NCT01366638|B4|Baseline|Total|Total of all reporting groups
202050|NCT01366638|B3|Baseline|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202051|NCT01366638|B2|Baseline|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202052|NCT01366638|B1|Baseline|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202053|NCT01366638|P3|Participant Flow|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202054|NCT01366638|P2|Participant Flow|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202055|NCT01366638|P1|Participant Flow|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202056|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202095|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
204070|NCT01359943|B4|Baseline|Total|Total of all reporting groups
202057|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202058|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202059|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202060|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202061|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202062|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202063|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202064|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202065|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202066|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202067|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202068|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202069|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202070|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202071|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202072|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202073|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202074|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202075|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202076|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202077|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202078|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202079|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202080|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202081|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202082|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202083|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202084|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202085|NCT01366638|E3|Reported Event|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
202086|NCT01366638|E2|Reported Event|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202087|NCT01366638|E1|Reported Event|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
202088|NCT01366534|B4|Baseline|Total|Total of all reporting groups
202089|NCT01366534|B3|Baseline|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202090|NCT01366534|B2|Baseline|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202091|NCT01366534|B1|Baseline|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202092|NCT01366534|P3|Participant Flow|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202093|NCT01366534|P2|Participant Flow|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202094|NCT01366534|P1|Participant Flow|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202233|NCT01366209|B3|Baseline|Total|Total of all reporting groups
202096|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202097|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202098|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202099|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202100|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202101|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202102|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202103|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202104|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202105|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202106|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202107|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202108|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202109|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202110|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202111|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202112|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202113|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202114|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202115|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202116|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202117|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202234|NCT01366209|B2|Baseline|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
203181|NCT01362894|E2|Reported Event|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
202118|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202119|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202120|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202121|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202122|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202123|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202124|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202125|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202126|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202127|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202128|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202129|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202130|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202131|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202132|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202133|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202134|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202135|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202136|NCT01366534|E3|Reported Event|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
202137|NCT01366534|E2|Reported Event|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202138|NCT01366534|E1|Reported Event|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
202139|NCT01366521|B5|Baseline|Total|Total of all reporting groups
202140|NCT01366521|B4|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
203182|NCT01362894|E1|Reported Event|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
202141|NCT01366521|B3|Baseline|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202142|NCT01366521|B2|Baseline|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202143|NCT01366521|B1|Baseline|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202144|NCT01366521|P4|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202145|NCT01366521|P3|Participant Flow|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202146|NCT01366521|P2|Participant Flow|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202147|NCT01366521|P1|Participant Flow|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202148|NCT01366521|O4|Outcome|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202149|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202150|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202151|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202152|NCT01366521|O4|Outcome|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202153|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202154|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202155|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202156|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202157|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202158|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202159|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202160|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202161|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202162|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
203183|NCT01362686|B4|Baseline|Total|Total of all reporting groups
202163|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202164|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202165|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202166|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202167|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202168|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202169|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202170|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202171|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202172|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202173|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202174|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202175|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202176|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202177|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202178|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202179|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202180|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202181|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202182|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202183|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202184|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202235|NCT01366209|B1|Baseline|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
203241|NCT01362530|B3|Baseline|Total|Total of all reporting groups
202185|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202186|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202187|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202188|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202189|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202190|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202191|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202192|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202193|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202194|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202195|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202196|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202197|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202198|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202199|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202200|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202201|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202202|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202203|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202204|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202205|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202206|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202236|NCT01366209|P2|Participant Flow|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
204972|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
202207|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202208|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202209|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202210|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202211|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202212|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202213|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202214|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202215|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202216|NCT01366521|E5|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202217|NCT01366521|E4|Reported Event|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202218|NCT01366521|E3|Reported Event|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202219|NCT01366521|E2|Reported Event|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202220|NCT01366521|E1|Reported Event|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
202221|NCT01366443|B1|Baseline|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
202222|NCT01366443|P1|Participant Flow|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
202223|NCT01366443|O2|Outcome|Pregnant Women (ROM Plus vs. Chart Review)|This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.
202224|NCT01366443|O1|Outcome|Pregnant Women (Clinical Assessment vs. Chart Review)|This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the standard clinical assessment for rupture of membranes. The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.
202225|NCT01366443|E1|Reported Event|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
202226|NCT01366417|B1|Baseline|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
202227|NCT01366417|P1|Participant Flow|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
202228|NCT01366417|O2|Outcome|70% Isopropyl Alcohol|All subjects received a single topical application of 70% Isopropyl Alcohol.
202229|NCT01366417|O1|Outcome|ChloraPrep One Step|All subjects received a single topical application of ChloraPrep One Step.
202230|NCT01366417|O2|Outcome|70% Isopropyl Alcohol|All subjects received a single topical application of 70% Isopropyl Alcohol.
202231|NCT01366417|O1|Outcome|ChloraPrep One Step|All subjects received a single topical application of ChloraPrep One Step.
202232|NCT01366417|E1|Reported Event|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
202239|NCT01366209|O1|Outcome|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
202240|NCT01366209|E2|Reported Event|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
202241|NCT01366209|E1|Reported Event|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
202242|NCT01366196|B3|Baseline|Total|Total of all reporting groups
202243|NCT01366196|B2|Baseline|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
202244|NCT01366196|B1|Baseline|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
202245|NCT01366196|P2|Participant Flow|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
202246|NCT01366196|P1|Participant Flow|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
202247|NCT01366196|O2|Outcome|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
202248|NCT01366196|O1|Outcome|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
202249|NCT01366196|O2|Outcome|Pregabalin Group (P)|Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
202250|NCT01366196|O1|Outcome|Control Group (C)|Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
202251|NCT01366196|E2|Reported Event|Pregabalin Group (P)|"Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.
All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.
On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.
Pregabalin 150 mg: Patients will receive two 75 mg capsules of pregabalin 1 hour before surgery. They continue to take 2 capsules of 75 mg (total 150 mg) until POD 14."
202252|NCT01366196|E1|Reported Event|Control Group (C)|"Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.
All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.
On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.
Placebo: Patients will first receive two capsules of the placebo drug (with no active ingredients per dose) one hour before surgery. Patients will continue taking two capsules per day until POD 14."
202253|NCT01366092|B1|Baseline|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
202254|NCT01366092|P1|Participant Flow|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
202255|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
202256|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
202257|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
202258|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
202259|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
202260|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
202261|NCT01366092|E1|Reported Event|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
202262|NCT01365910|B1|Baseline|Treatment (Enzyme Inhibitor)|Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
202263|NCT01365910|P1|Participant Flow|Treatment (Enzyme Inhibitor)|ABT-869/Linifanib will be administered orally on a daily basis at 17.5 mg/day (fixed dose). The drug is provided in tablets of 2.5 mg or 10 mg tablets.This course of treatment repeats every 28 days until disease progression, intolerability, investigator decision or patient withdrawal of consent.
202264|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
linifanib: Given PO"
202265|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
linifanib: Given PO"
202266|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
linifanib: Given PO"
202267|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
linifanib: Given PO"
204682|NCT01357980|B4|Baseline|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
202268|NCT01365910|E1|Reported Event|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
linifanib: Given PO"
202269|NCT01365845|B1|Baseline|Breast Patients Planned With Both Proton & Conventional Plans|"Each patient is planned with both proton and conventional plans and the superior plan is chosen for treatment.
Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction"
202270|NCT01365845|P3|Participant Flow|3D-Proton/Conventional Plan or 3D-proton Only|"3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy
This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment."
202271|NCT01365845|P2|Participant Flow|Conventional Photon Plan|"Conventional (photon): 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment."
202272|NCT01365845|P1|Participant Flow|Induction Phase|During this phase, each patient will have both a proton and conventional radiation plan performed. The superior plan in regard to minimizing dose to heart will be the plan actually chosen for treating the patient.
202273|NCT01365845|O2|Outcome|3D-Proton/Conventional Plan or 3D-proton Only|3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy per fraction
202274|NCT01365845|O1|Outcome|Conventional Photon Plan|Photon: 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
202275|NCT01365845|E1|Reported Event|Breast Patients Planned With Both Proton & Conventional Plans|"All patients ultimately treated under the proton plan, so the denominator for all adverse events refers exclusively to the proton arm and not conventional.
Each patient was planned with both proton and conventional plans and the superior plan was chosen for treatment.
Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction"
202276|NCT01365819|B3|Baseline|Total|Total of all reporting groups
202277|NCT01365819|B2|Baseline|Varenicline|"Varenicline (Chantix (R))
Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
202278|NCT01365819|B1|Baseline|Sugar Pill|"Placebo
Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
202279|NCT01365819|P2|Participant Flow|Varenicline|"Varenicline (Chantix (R))
Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
202280|NCT01365819|P1|Participant Flow|Sugar Pill|"Placebo
Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
202281|NCT01365819|O2|Outcome|Varenicline|"Varenicline (Chantix (R))
Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
202282|NCT01365819|O1|Outcome|Sugar Pill|"Placebo
Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
202283|NCT01365819|E2|Reported Event|Varenicline|"Varenicline (Chantix (R))
Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
202284|NCT01365819|E1|Reported Event|Sugar Pill|"Placebo
Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
202285|NCT01365650|B1|Baseline|All Study Participants|Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3
202286|NCT01365650|P1|Participant Flow|Symptomatic Allergic Rhinitis|Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3
202287|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
202288|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
204973|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
202289|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
202290|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
202291|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
202292|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
202293|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
202294|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
202295|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
202296|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
202297|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
202298|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
202299|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
202300|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
202301|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
202302|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
202303|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
202304|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
202305|NCT01365650|E3|Reported Event|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
202306|NCT01365650|E2|Reported Event|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
202307|NCT01365650|E1|Reported Event|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
202308|NCT01365624|B3|Baseline|Total|Total of all reporting groups
202309|NCT01365624|B2|Baseline|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202310|NCT01365624|B1|Baseline|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202311|NCT01365624|P2|Participant Flow|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202312|NCT01365624|P1|Participant Flow|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202313|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202314|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202315|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202316|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202317|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202318|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
204974|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
202319|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202320|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202321|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202322|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202323|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202324|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202325|NCT01365624|E2|Reported Event|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202326|NCT01365624|E1|Reported Event|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
202327|NCT01365611|B1|Baseline|All Study Participants|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6. Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
202328|NCT01365611|P1|Participant Flow|All Study Participants|"A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6."
202329|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
202330|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
202331|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
202332|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
202333|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
202334|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
202335|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
202336|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
202337|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
202338|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
202339|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
202340|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
202341|NCT01365611|E2|Reported Event|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
202342|NCT01365611|E1|Reported Event|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
202343|NCT01365585|B1|Baseline|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202344|NCT01365585|P1|Participant Flow|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202345|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202346|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202641|NCT01364740|E1|Reported Event|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
202347|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202348|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202349|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202350|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202351|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202352|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202353|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202354|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202355|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202356|NCT01365585|E1|Reported Event|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
202357|NCT01365546|B1|Baseline|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
202358|NCT01365546|P1|Participant Flow|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
202359|NCT01365546|O1|Outcome|Post-operative Assessment by IDMC|
202360|NCT01365546|O1|Outcome|Intra-operative Assessment by IDMC|
202361|NCT01365546|O3|Outcome|All Surgeries|
202362|NCT01365546|O2|Outcome|Major Surgery|
202363|NCT01365546|O1|Outcome|Minor Surgery|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
202364|NCT01365546|E1|Reported Event|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
202365|NCT01365507|B3|Baseline|Total|Total of all reporting groups
202366|NCT01365507|B2|Baseline|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
202367|NCT01365507|B1|Baseline|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
202368|NCT01365507|P2|Participant Flow|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
202369|NCT01365507|P1|Participant Flow|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
202370|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
202371|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
202372|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
202642|NCT01364727|B1|Baseline|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
202373|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
202374|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
202375|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
202376|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
202377|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
202378|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
202379|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
202380|NCT01365507|E2|Reported Event|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
202381|NCT01365507|E1|Reported Event|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
202382|NCT01365494|B3|Baseline|Total|Total of all reporting groups
202383|NCT01365494|B2|Baseline|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedules."
202384|NCT01365494|B1|Baseline|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedules."
202385|NCT01365494|P2|Participant Flow|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
202386|NCT01365494|P1|Participant Flow|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to either Zagreb schedule."
202387|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
202388|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
202389|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
202390|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb schedule) (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
202391|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
202392|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
202643|NCT01364727|P1|Participant Flow|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
204975|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
202393|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
202394|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
202395|NCT01365494|E2|Reported Event|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
202396|NCT01365494|E1|Reported Event|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)
Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
202397|NCT01365481|B5|Baseline|Total|Total of all reporting groups
202398|NCT01365481|B4|Baseline|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202399|NCT01365481|B3|Baseline|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202400|NCT01365481|B2|Baseline|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202401|NCT01365481|B1|Baseline|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202402|NCT01365481|P4|Participant Flow|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202403|NCT01365481|P3|Participant Flow|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202404|NCT01365481|P2|Participant Flow|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202405|NCT01365481|P1|Participant Flow|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202406|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202407|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202408|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202644|NCT01364727|O1|Outcome|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
202409|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202410|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202411|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202412|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202413|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202414|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202415|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202416|NCT01365481|E6|Reported Event|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202417|NCT01365481|E5|Reported Event|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202418|NCT01365481|E4|Reported Event|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202419|NCT01365481|E3|Reported Event|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202420|NCT01365481|E2|Reported Event|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
202421|NCT01365481|E1|Reported Event|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
202422|NCT01365468|B3|Baseline|Total|Total of all reporting groups
202645|NCT01364727|O1|Outcome|Amrubicin|Amrubicin 35mg/m2 IV days 1 to 3 every 3 weeks until progression or toxicity
202646|NCT01364727|O1|Outcome|Amrubicin|
202423|NCT01365468|B2|Baseline|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202424|NCT01365468|B1|Baseline|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202425|NCT01365468|P2|Participant Flow|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202426|NCT01365468|P1|Participant Flow|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202427|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202428|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202429|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202430|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202431|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202432|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202433|NCT01365468|O1|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202434|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202435|NCT01365468|E2|Reported Event|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202436|NCT01365468|E1|Reported Event|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
202437|NCT01365455|B4|Baseline|Total|Total of all reporting groups
202438|NCT01365455|B3|Baseline|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202647|NCT01364727|E1|Reported Event|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
202648|NCT01364649|B3|Baseline|Total|Total of all reporting groups
202439|NCT01365455|B2|Baseline|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202440|NCT01365455|B1|Baseline|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202441|NCT01365455|P5|Participant Flow|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202442|NCT01365455|P4|Participant Flow|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202443|NCT01365455|P3|Participant Flow|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202444|NCT01365455|P2|Participant Flow|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202445|NCT01365455|P1|Participant Flow|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202446|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202447|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202448|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202449|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202450|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202451|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202452|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202453|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202454|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202455|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202456|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202457|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
204976|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
202458|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202459|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202460|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202461|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202462|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202463|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202464|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202465|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202466|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202467|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202468|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202469|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202470|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202471|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202472|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202473|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202474|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202475|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202476|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
204977|NCT01357239|O3|Outcome|Placebo|2 capsules of placebo per intake
202477|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202478|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202479|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202480|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202481|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202482|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202483|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202484|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202485|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202486|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202487|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202488|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202489|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202490|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202491|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202492|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202493|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202494|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202495|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202496|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202497|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202498|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202499|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202500|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202501|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202502|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202503|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202504|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202505|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202506|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202507|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202508|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202509|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202510|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202511|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202512|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202513|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202514|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202823|NCT01363700|B2|Baseline|Epinastine / Epinastine Period1|Epinastine / Epinastine : DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
202515|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202516|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202517|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202518|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
202519|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202520|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
202521|NCT01365455|E11|Reported Event|FOLLOW UP-Placebo|FOLLOW UP-Placebo
202522|NCT01365455|E10|Reported Event|FOLLOW UP-Any AIN457 300mg|FOLLOW UP-Any AIN457 300mg
202523|NCT01365455|E9|Reported Event|FOLLOW UP-Any AIN457 150mg|FOLLOW UP-Any AIN457 150mg
202524|NCT01365455|E8|Reported Event|ENTIRE-Placebo|ENTIRE-Placebo
202525|NCT01365455|E7|Reported Event|ENTIRE-Any AIN457 300mg|ENTIRE-Any AIN457 300mg
202526|NCT01365455|E6|Reported Event|ENTIRE-Any AIN457 150mg|ENTIRE-Any AIN457 150mg
202527|NCT01365455|E5|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
202528|NCT01365455|E4|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
202529|NCT01365455|E3|Reported Event|INDUCTION-Placebo|INDUCTION-Placebo
202530|NCT01365455|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
202531|NCT01365455|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
202532|NCT01365273|B3|Baseline|Total|Total of all reporting groups
202533|NCT01365273|B2|Baseline|Mepitel One|Device
202534|NCT01365273|B1|Baseline|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
202535|NCT01365273|P2|Participant Flow|Mepitel One|Device
202536|NCT01365273|P1|Participant Flow|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
202537|NCT01365273|O2|Outcome|Mepitel One|Device
202538|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
202539|NCT01365273|O2|Outcome|Mepitel One|Device
202540|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
202541|NCT01365273|O2|Outcome|Mepitel One|Device
202542|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
202543|NCT01365273|E2|Reported Event|Mepitel One|Device
202544|NCT01365273|E1|Reported Event|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
202545|NCT01365130|B1|Baseline|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity
jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
202546|NCT01365130|P1|Participant Flow|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity
jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
202547|NCT01365130|O1|Outcome|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity
jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
202548|NCT01365130|E1|Reported Event|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity
jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
202549|NCT01365091|B5|Baseline|Total|Total of all reporting groups
202550|NCT01365091|B4|Baseline|Arm 4: Treatments G/ H, H/G|"Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
202551|NCT01365091|B3|Baseline|Arm 3:Treatments E/ F, F/E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
202874|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
202552|NCT01365091|B2|Baseline|Arm 2: Treatments C/D, D/C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
202553|NCT01365091|B1|Baseline|Arm 1: Treatments A/B, B/A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
202554|NCT01365091|P4|Participant Flow|Arm 4: Treatments G/ H, H/G|"Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
202555|NCT01365091|P3|Participant Flow|Arm 3:Treatments E/ F, F/E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
202556|NCT01365091|P2|Participant Flow|Arm 2: Treatments C/D, D/C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
202557|NCT01365091|P1|Participant Flow|Arm 1: Treatments A/B, B/A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
202558|NCT01365091|O4|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
202559|NCT01365091|O3|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fasted|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
202560|NCT01365091|O2|Outcome|Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
202596|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
202597|NCT01365052|E2|Reported Event|Placebo|2 over-encapsulated tablets of placebo are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
202561|NCT01365091|O1|Outcome|Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fasted|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
202562|NCT01365091|O4|Outcome|Arm 4: Treatments G,H/H,G|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
202563|NCT01365091|O3|Outcome|Arm 3: Treatments E,F/ F,E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
202564|NCT01365091|O2|Outcome|Arm 2: Treatments C,D/D,C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
202565|NCT01365091|O1|Outcome|Arm 1: Treatments A,B/B,A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
202566|NCT01365091|O4|Outcome|Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
202567|NCT01365091|O3|Outcome|Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fasting|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
202568|NCT01365091|O2|Outcome|Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met 500 mg FDC Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
202569|NCT01365091|O1|Outcome|Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met, 500 mg FDC Fasting|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
202598|NCT01365052|E1|Reported Event|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
202599|NCT01365039|B3|Baseline|Total|Total of all reporting groups
202570|NCT01365091|O4|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
202571|NCT01365091|O3|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fasted|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
202572|NCT01365091|O2|Outcome|Sax, 5 mg/Met 500 mg vs FDC to Individual Tablets, Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.
Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
202573|NCT01365091|O1|Outcome|Sax, 5 mg/Met 500 mg XR FDC vs Individual Tablets, Fasted|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.
Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
202574|NCT01365091|E8|Reported Event|Saxagliptin, 5 mg/Metformin, 500 mg FDC Fed|FDC=fixed-dose combination
202575|NCT01365091|E7|Reported Event|Saxagliptin, 5 mg/Metformin, 500 mg FDC Fasting|FDC=fixed-dose combination
202576|NCT01365091|E6|Reported Event|Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fed|FDC=fixed-dose combination
202577|NCT01365091|E5|Reported Event|Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fasting|FDC=fixed-dose combination
202578|NCT01365091|E4|Reported Event|Saxagliptin, 5 mg/Metformin XR, 500 mg Fed|XR=extended release
202579|NCT01365091|E3|Reported Event|Saxagliptin, 5 mg/Metformin XR, 500 mg Fasting|XR=extended release
202580|NCT01365091|E2|Reported Event|Saxagliptin, 5 mg/Metformin XR, 1000 mg Fed|XR=extended release
202581|NCT01365091|E1|Reported Event|Saxagliptin, 5 mg/Metformin XR, 1000 mg Fasting|XR=extended release
202582|NCT01365052|B3|Baseline|Total|Total of all reporting groups
202583|NCT01365052|B2|Baseline|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
202584|NCT01365052|B1|Baseline|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
202585|NCT01365052|P2|Participant Flow|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
202586|NCT01365052|P1|Participant Flow|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
202587|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
202588|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
202589|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
202590|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
202591|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
202592|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
202593|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
202594|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
202595|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
202638|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
202600|NCT01365039|B2|Baseline|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.
Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
202601|NCT01365039|B1|Baseline|SofLens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
202602|NCT01365039|P2|Participant Flow|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.
Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
202603|NCT01365039|P1|Participant Flow|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
202604|NCT01365039|O2|Outcome|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.
Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
202605|NCT01365039|O1|Outcome|SofLens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
202606|NCT01365039|O2|Outcome|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.
Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
202607|NCT01365039|O1|Outcome|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
202608|NCT01365039|E2|Reported Event|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.
Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
202609|NCT01365039|E1|Reported Event|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
202610|NCT01364922|B4|Baseline|Total|Total of all reporting groups
202611|NCT01364922|B3|Baseline|DB Placebo|1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
202612|NCT01364922|B2|Baseline|DB Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
202613|NCT01364922|B1|Baseline|OL Hydrocodone/Acetaminophen Extended Release (Nonrandomized)|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period; these participants were not randomized and did not progress to the double-blind period.
202614|NCT01364922|P3|Participant Flow|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
202615|NCT01364922|P2|Participant Flow|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
202616|NCT01364922|P1|Participant Flow|Open-label Hydrocodone/Acetaminophen Extended Release|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks.
202617|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
202618|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
202619|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
202620|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
202621|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
202622|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
202623|NCT01364922|E3|Reported Event|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
202624|NCT01364922|E2|Reported Event|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
202639|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
202625|NCT01364922|E1|Reported Event|Open-label Hydrocodone/Acetaminophen Extended Release|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period.
202626|NCT01364896|B1|Baseline|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
Anal cytology testing"
202627|NCT01364896|P1|Participant Flow|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
Anal cytology testing"
202628|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
Anal cytology testing"
202629|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
Anal cytology testing"
202630|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
Anal cytology testing"
202631|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
Anal cytology testing"
202632|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
Anal cytology testing"
202633|NCT01364896|E1|Reported Event|Inflammatory Bowel Disease, Immunosuppressive Agent|Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
202634|NCT01364740|B1|Baseline|PMP-300E, In-Lab PSG|"PMP-300E, In-Lab PSG: PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study)
PMP-300E: Data collected from Level 3 device
In-lab PSG: Data collected from Type I In-Lab Polysomnography"
202635|NCT01364740|P1|Participant Flow|SmartWatch PMP-300E|"Investigational device Smart Watch PMP-300E to measure sleep-related breathing was tested against conventional gold-standard In-Lab Polysomnography (sleep studies)
Smart Watch PMP-300E: Data collected from a Level 3 portable monitoring device
In-lab Polysomnography: Data collected from Type I In-Lab Polysomnography"
202636|NCT01364740|O1|Outcome|PMP-300E|Patient questionnaire data collected after one night with the PMP-300E
202637|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
202649|NCT01364649|B2|Baseline|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
202650|NCT01364649|B1|Baseline|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
202651|NCT01364649|P2|Participant Flow|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
202652|NCT01364649|P1|Participant Flow|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
202653|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
202654|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
202655|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
202656|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
202657|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
202658|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
202659|NCT01364649|E2|Reported Event|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
202660|NCT01364649|E1|Reported Event|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
202661|NCT01364558|B1|Baseline|Diazepam Nasal Spray Suspension/Spray/Injection|
202662|NCT01364558|P3|Participant Flow|Diazepam Injection|Diazepam injection
202663|NCT01364558|P2|Participant Flow|Diazepam Nasal Spray Solution|Diazepam Nasal Spray Solution
202664|NCT01364558|P1|Participant Flow|Diazepam Nasal Spray Suspension|Diazepam Nasal Spray Suspension
202665|NCT01364558|O3|Outcome|Diazepam Injection|Diazepam injection
202666|NCT01364558|O2|Outcome|Diazepam Nasal Spray Solution|Diazepam Nasal Spray Solution
202667|NCT01364558|O1|Outcome|Diazepam Nasal Spray Suspension|Diazepam Nasal Spray Suspension
202668|NCT01364558|E3|Reported Event|Diazepam Injection|
202669|NCT01364558|E2|Reported Event|Diazepam Nasal Spray Solution|
202670|NCT01364558|E1|Reported Event|Diazepam Nasal Spray Suspension|
202671|NCT01364428|B3|Baseline|Total|Total of all reporting groups
202672|NCT01364428|B2|Baseline|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
202673|NCT01364428|B1|Baseline|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
202674|NCT01364428|P2|Participant Flow|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
202675|NCT01364428|P1|Participant Flow|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
202676|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
202677|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
202756|NCT01363986|P1|Participant Flow|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenously (i.v.) on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
202678|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
202679|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
202680|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
202681|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
202682|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
202683|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
202684|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
202685|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
202686|NCT01364428|E2|Reported Event|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
202687|NCT01364428|E1|Reported Event|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
202688|NCT01364389|B4|Baseline|Total|Total of all reporting groups
202689|NCT01364389|B3|Baseline|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
202690|NCT01364389|B2|Baseline|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202691|NCT01364389|B1|Baseline|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202692|NCT01364389|P3|Participant Flow|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
202693|NCT01364389|P2|Participant Flow|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202694|NCT01364389|P1|Participant Flow|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202695|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
204978|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
202696|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202697|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202698|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
202699|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202700|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202701|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
202702|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202703|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202704|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
202705|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202706|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202707|NCT01364389|E3|Reported Event|Prednisone 20mg|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
202708|NCT01364389|E2|Reported Event|AIN457 3mg/kg|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202709|NCT01364389|E1|Reported Event|ACZ885 3mg/kg|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
202710|NCT01364298|B3|Baseline|Total|Total of all reporting groups
202711|NCT01364298|B2|Baseline|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202712|NCT01364298|B1|Baseline|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202713|NCT01364298|P2|Participant Flow|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202714|NCT01364298|P1|Participant Flow|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202715|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202716|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202717|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202718|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202719|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202720|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202721|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202722|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202723|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202724|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202725|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202726|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202727|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202728|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202729|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202730|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202731|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202732|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202733|NCT01364298|E2|Reported Event|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
202734|NCT01364298|E1|Reported Event|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
202735|NCT01364259|B3|Baseline|Total|Total of all reporting groups
202736|NCT01364259|B2|Baseline|Amifostine|"Amifostine and CyberKnife stereotactic radiosurgery
CyberKnife stereotactic radiosurgery + amofostine"
202737|NCT01364259|B1|Baseline|Placebo|"Placebo and SRS
CyberKnife stereotactic radiosurgery + saline"
202738|NCT01364259|P2|Participant Flow|Amifostine|"Amifostine and SRS
CyberKnife stereotactic radiosurgery and Amifostine"
202739|NCT01364259|P1|Participant Flow|Placebo|"Placebo and SRS
CyberKnife stereotactic radiosurgery (srs)"
202740|NCT01364259|O2|Outcome|Amifostine|"Amifostine and SRS
CyberKnife stereotactic radiosurgery and Amifostine"
202741|NCT01364259|O1|Outcome|Placebo|"Placebo and SRS
CyberKnife stereotactic radiosurgery (srs)"
202742|NCT01364259|O2|Outcome|Amifostine|"Amifostine and SRS
CyberKnife stereotactic radiosurgery and Amifostine"
202743|NCT01364259|O1|Outcome|Placebo|"Placebo and SRS
CyberKnife stereotactic radiosurgery (srs)"
202744|NCT01364259|E2|Reported Event|Amifostine|"Amifostine and SRS
CyberKnife stereotactic radiosurgery and Amifostine"
202745|NCT01364259|E1|Reported Event|Placebo|"Placebo and SRS
CyberKnife stereotactic radiosurgery (srs)"
202746|NCT01364207|B1|Baseline|All Participants Who Completed Both Study Visits|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.
202747|NCT01364207|P2|Participant Flow|Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit|Participants drank an 8 oz cup of decaffeinated coffee on the their first visit, and then an 8 oz cup of caffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.
202748|NCT01364207|P1|Participant Flow|Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit|Participants drank an 8 oz cup of caffeinated coffee on the their first visit, and then an 8 oz cup of decaffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.
202749|NCT01364207|O2|Outcome|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
202750|NCT01364207|O1|Outcome|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
202751|NCT01364207|O2|Outcome|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
202752|NCT01364207|O1|Outcome|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
202753|NCT01364207|E2|Reported Event|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
202754|NCT01364207|E1|Reported Event|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
202755|NCT01363986|B1|Baseline|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
202820|NCT01363713|E1|Reported Event|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
202757|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
202758|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
202759|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
202760|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
202761|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
202762|NCT01363986|E1|Reported Event|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
202763|NCT01363908|B3|Baseline|Total|Total of all reporting groups
202764|NCT01363908|B2|Baseline|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202765|NCT01363908|B1|Baseline|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202766|NCT01363908|P2|Participant Flow|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202767|NCT01363908|P1|Participant Flow|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202768|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202769|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202770|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202771|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202772|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202773|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202774|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202775|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202776|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202777|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202821|NCT01363700|B4|Baseline|Total|Total of all reporting groups
202822|NCT01363700|B3|Baseline|Placebo / Placebo Period1|Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
202778|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202779|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202780|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202781|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202782|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202783|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202784|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202785|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202786|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202787|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202788|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202789|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202790|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202791|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202792|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202793|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202794|NCT01363908|E2|Reported Event|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
202795|NCT01363908|E1|Reported Event|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
204979|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
202796|NCT01363843|B1|Baseline|Study Arm|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles
Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
Capecitabine 825 mg/m2 PO BID
50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)
Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
Capecitabine"
202797|NCT01363843|P1|Participant Flow|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles
Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
Capecitabine 825 mg/m2 PO BID
50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)
Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
Capecitabine"
202798|NCT01363843|O1|Outcome|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles
Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
Capecitabine 825 mg/m2 PO BID
50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)
Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
Capecitabine"
202799|NCT01363843|E1|Reported Event|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Repeat q14 days x 8 cycles
Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)
Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
Capecitabine"
202800|NCT01363765|B3|Baseline|Total|Total of all reporting groups
202801|NCT01363765|B2|Baseline|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
202802|NCT01363765|B1|Baseline|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
202803|NCT01363765|P2|Participant Flow|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
202804|NCT01363765|P1|Participant Flow|Xpert MTB/Rif|Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
202805|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
202806|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
202807|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
202808|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
202809|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
202810|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
202811|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine smear staining
202812|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period was submitted to this technology
202813|NCT01363765|E2|Reported Event|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
202814|NCT01363765|E1|Reported Event|Xpert MTB/Rif|Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
202815|NCT01363713|B1|Baseline|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
202816|NCT01363713|P1|Participant Flow|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
202817|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
202818|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
202819|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
202824|NCT01363700|B1|Baseline|Epinastine / Placebo Period1|Epinastine / Placebo : DE-114 ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
202825|NCT01363700|P5|Participant Flow|Epinastine / Placebo Period2|Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
202826|NCT01363700|P4|Participant Flow|Olopatadine / Placebo Period2|Olopatadine / Placebo : Olopatadine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
202827|NCT01363700|P3|Participant Flow|Placebo / Placebo Period1|Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
202828|NCT01363700|P2|Participant Flow|Epinastine / Epinastine Period1|Epinastine / Epinastine : Epinastine ophthalmic solution, 1 drop in each eye at designated visits.
202829|NCT01363700|P1|Participant Flow|Epinastine / Placebo Period1|Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
202830|NCT01363700|O3|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
202831|NCT01363700|O2|Outcome|Olopatadine Ophthalmic Solution|Count unit was defined each eye.
202832|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
202833|NCT01363700|O3|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
202834|NCT01363700|O2|Outcome|Olopatadine Ophthalmic Solution|Count unit was defined each eye.
202835|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
202836|NCT01363700|O2|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
202837|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
202838|NCT01363700|O2|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
202839|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
202840|NCT01363700|E5|Reported Event|Placebo Ophthalmic Solution Period2|Count unit was defined each eye.
202841|NCT01363700|E4|Reported Event|Olopatadine Ophthalmic Solution Period2|Count unit was defined each eye.
202842|NCT01363700|E3|Reported Event|Epinastine (DE-114) Ophthalmic Solution Period2|Count unit was defined each eye.
202843|NCT01363700|E2|Reported Event|Placebo Ophthalmic Solution Period1|Count unit was defined each eye.
202844|NCT01363700|E1|Reported Event|Epinastine (DE-114) Ophthalmic Solution Period1|Count unit was defined each eye.
202845|NCT01363661|B3|Baseline|Total|Total of all reporting groups
202846|NCT01363661|B2|Baseline|Placebo|"Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)"
202847|NCT01363661|B1|Baseline|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day"
202848|NCT01363661|P2|Participant Flow|Placebo|"Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)"
202849|NCT01363661|P1|Participant Flow|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day"
202850|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)"
202851|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day"
202852|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)"
202853|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day"
202854|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)"
202855|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day"
202856|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)"
202857|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day"
202858|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)"
202859|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day"
202860|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)"
202861|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day"
202862|NCT01363661|E2|Reported Event|Placebo|"Placebo (16 mg tablet; once a day)
Placebo: Placebo (16 mg tablet, per os; once-daily)"
202863|NCT01363661|E1|Reported Event|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)
Coruno: Molsidomine 16 mg tablet, per os, once a day"
202864|NCT01363492|B1|Baseline|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
202865|NCT01363492|P1|Participant Flow|Replagal® (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes every other week (EOW)
202866|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
202867|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
202868|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
202869|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
202870|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
202871|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
202872|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
202873|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
202875|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes every other week (EOW)
202876|NCT01363492|E1|Reported Event|Replagal® (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
202877|NCT01363479|B3|Baseline|Total|Total of all reporting groups
202878|NCT01363479|B2|Baseline|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
I.V. palonosetron
Dexamethasone"
202879|NCT01363479|B1|Baseline|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Oral palonosetron
Dexamethasone"
202880|NCT01363479|P2|Participant Flow|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
I.V. palonosetron
Dexamethasone"
202881|NCT01363479|P1|Participant Flow|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Oral palonosetron
Dexamethasone"
202882|NCT01363479|O2|Outcome|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
I.V. palonosetron
Dexamethasone"
202883|NCT01363479|O1|Outcome|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Oral palonosetron
Dexamethasone"
202884|NCT01363479|E2|Reported Event|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
I.V. palonosetron
Dexamethasone"
202885|NCT01363479|E1|Reported Event|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Oral palonosetron
Dexamethasone"
202886|NCT01363440|B4|Baseline|Total|Total of all reporting groups
202887|NCT01363440|B3|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
202888|NCT01363440|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
202889|NCT01363440|B1|Baseline|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
202890|NCT01363440|P3|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
202891|NCT01363440|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
202892|NCT01363440|P1|Participant Flow|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
202893|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
202894|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
202895|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
202896|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
202897|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
202898|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
202899|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
202900|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
202901|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
202902|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
202903|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
202904|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
202905|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
202906|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
202907|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
202908|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
202909|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
202910|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
202911|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
202912|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
202913|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
202914|NCT01363440|E6|Reported Event|IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 148)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
202915|NCT01363440|E5|Reported Event|IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 148)|Participants received 2mg Intravitreal aflibercept injection(IAI) every 4 weeks.
202916|NCT01363440|E4|Reported Event|Control (Week 0 to Week 148)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
202917|NCT01363440|E3|Reported Event|IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 100)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
202918|NCT01363440|E2|Reported Event|IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 100)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
202919|NCT01363440|E1|Reported Event|Control (Week 0 to Week 100)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
202920|NCT01363401|B3|Baseline|Total|Total of all reporting groups
202921|NCT01363401|B2|Baseline|No Treatment|"No treatment with HYNR-CS inj.
Take each 50mg 1 hour before a meal or 2 hours after a meal at least at an interval of 12 hours, 28 weeks(12 weeks of run-in phase plus 16 weeks of treatment phase)"
202922|NCT01363401|B1|Baseline|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.
intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
202923|NCT01363401|P2|Participant Flow|No Treatment|No treatment with HYNR-CS inj.
202924|NCT01363401|P1|Participant Flow|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.
intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
202925|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
202926|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.
intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
202927|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
202928|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.
intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
202929|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
202930|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.
intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
202931|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
202932|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.
intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
202933|NCT01363401|E2|Reported Event|No Treatment|No treatment with HYNR-CS inj.
202934|NCT01363401|E1|Reported Event|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.
intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
202935|NCT01363349|B3|Baseline|Total|Total of all reporting groups
202936|NCT01363349|B2|Baseline|Risperidone|"2-6 mg, 6 months
Risperidone"
202937|NCT01363349|B1|Baseline|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
202938|NCT01363349|P2|Participant Flow|Risperidone|"2-6 mg, 6 months
Risperidone"
202939|NCT01363349|P1|Participant Flow|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
202940|NCT01363349|O2|Outcome|Risperidone|"2-6 mg, 6 months
Risperidone"
202941|NCT01363349|O1|Outcome|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
202942|NCT01363349|E2|Reported Event|Risperidone|"2-6 mg, 6 months
Risperidone"
202943|NCT01363349|E1|Reported Event|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
202944|NCT01363297|B6|Baseline|Total|Total of all reporting groups
202945|NCT01363297|B5|Baseline|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202946|NCT01363297|B4|Baseline|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202947|NCT01363297|B3|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202948|NCT01363297|B2|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202949|NCT01363297|B1|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
202950|NCT01363297|P5|Participant Flow|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202951|NCT01363297|P4|Participant Flow|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202952|NCT01363297|P3|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202953|NCT01363297|P2|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202954|NCT01363297|P1|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
202955|NCT01363297|O1|Outcome|Pharmacogenomics Population|All participants who gave consent for the optional blood sample for pharmacogenomic analyses, received at least 1 dose of any study drug, and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment.
202956|NCT01363297|O6|Outcome|All Doses|
202957|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202958|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202959|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202960|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202961|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
202962|NCT01363297|O6|Outcome|All Doses|
202963|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202964|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202965|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202966|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202967|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
202968|NCT01363297|O6|Outcome|All Doses|
202969|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202970|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202971|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202972|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202973|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
202974|NCT01363297|O6|Outcome|All Doses|
202975|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202976|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202977|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202978|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202979|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
202980|NCT01363297|O6|Outcome|All Doses|
202981|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202982|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202983|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
204980|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
202984|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202985|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
202986|NCT01363297|O6|Outcome|All Doses|
202987|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202988|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202989|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202990|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202991|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
202992|NCT01363297|O6|Outcome|All Doses|
202993|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202994|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202995|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202996|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
202997|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
202998|NCT01363297|O6|Outcome|All Doses|
202999|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203000|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203001|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203002|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203003|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
203004|NCT01363297|O6|Outcome|All Doses|
203005|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203006|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203007|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203008|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203009|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
203010|NCT01363297|O6|Outcome|All Doses|
203011|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203012|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203013|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203014|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203015|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
203016|NCT01363297|O6|Outcome|All Doses|
203017|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203171|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203018|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203019|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203020|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203021|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
203022|NCT01363297|O1|Outcome|All Doses|
203023|NCT01363297|O6|Outcome|All Doses|
203024|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203025|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203026|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203027|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203028|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
203029|NCT01363297|O1|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203030|NCT01363297|O1|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203031|NCT01363297|O1|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203032|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203033|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203034|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
203035|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203036|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203037|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
203038|NCT01363297|E5|Reported Event|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203039|NCT01363297|E4|Reported Event|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203040|NCT01363297|E3|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203041|NCT01363297|E2|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
203042|NCT01363297|E1|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
203043|NCT01363076|B3|Baseline|Total|Total of all reporting groups
203044|NCT01363076|B2|Baseline|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
203045|NCT01363076|B1|Baseline|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
203046|NCT01363076|P2|Participant Flow|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
203047|NCT01363076|P1|Participant Flow|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
203048|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
203049|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
203050|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
203051|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
203052|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
203053|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
203054|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
203055|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
203056|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
203057|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
203058|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
203059|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
203060|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
203061|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
203062|NCT01363076|E2|Reported Event|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
203063|NCT01363076|E1|Reported Event|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
203064|NCT01363050|B1|Baseline|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203065|NCT01363050|P1|Participant Flow|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203066|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203067|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203068|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203069|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203070|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203071|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203072|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203073|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1) : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203074|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1) : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203075|NCT01363050|E1|Reported Event|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
203076|NCT01363011|B3|Baseline|Total|Total of all reporting groups
203077|NCT01363011|B2|Baseline|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203078|NCT01363011|B1|Baseline|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203079|NCT01363011|P2|Participant Flow|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to cobicistat (Tybost®; COBI) 150 mg, while continuing the other components of their ARV regimen (atazanavir (ATV) 300 mg or darunavir (DRV) 800 mg plus 2 nucleoside reverse transcriptase inhibitors (NRTI)) for up to 96 weeks. These 2 NRTIs may have included abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF), administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203172|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203173|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
204981|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
203080|NCT01363011|P1|Participant Flow|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior antiretroviral (ARV) treatment and who were virologically unsuppressed at baseline initiated treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203081|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203082|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203083|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203084|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203085|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203086|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203087|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203088|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203089|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203090|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203091|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203092|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203174|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203175|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203093|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203094|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203095|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203096|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203097|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203098|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203099|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203100|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203101|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203102|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203103|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203104|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203105|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203176|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203106|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203107|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203108|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203109|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203110|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203111|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203112|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203113|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203114|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203115|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203116|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203117|NCT01363011|E2|Reported Event|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTI) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
203118|NCT01363011|E1|Reported Event|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.
Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
203177|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203178|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
204982|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
203119|NCT01362946|B1|Baseline|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203120|NCT01362946|P2|Participant Flow|Standard Behavior Treatment Then Modified Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
203121|NCT01362946|P1|Participant Flow|Modified Behavior Treatment Then Standard Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment.
203122|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons.
203123|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons.
203124|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203125|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203126|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203127|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203128|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203129|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203130|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203131|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203179|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203180|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
204983|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
203132|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203133|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203134|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203135|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203136|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203137|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203138|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203139|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203140|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203141|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203142|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203143|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203144|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
204984|NCT01357239|O2|Outcome|Placebo|2 capsules of placebo per intake
203145|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203146|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203147|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203148|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203149|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203150|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
203151|NCT01362946|E2|Reported Event|Standard Behavior Treatment Then Modified Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
203152|NCT01362946|E1|Reported Event|Modified Behavior Treatment Then Standard Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment.
203153|NCT01362907|B1|Baseline|Overall|All enrolled participants
203154|NCT01362907|P2|Participant Flow|Etafilcon A / Delefilcon A|Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
203155|NCT01362907|P1|Participant Flow|Delefilcon A / Etafilcon A|Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
203156|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203157|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203158|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203159|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203160|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203161|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203162|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203163|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203164|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203165|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203166|NCT01362907|E2|Reported Event|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203167|NCT01362907|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
203168|NCT01362894|B1|Baseline|Overall|All enrolled and dispensed participants.
203169|NCT01362894|P2|Participant Flow|Etafilcon A / Nelfilcon A|Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
203170|NCT01362894|P1|Participant Flow|Nelfilcon A / Etafilcon A|Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
203184|NCT01362686|B3|Baseline|Rivastigmine|"See intervention note.
Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203185|NCT01362686|B2|Baseline|Galantamine|"See intervention note.
Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203186|NCT01362686|B1|Baseline|Donepezil|"See intervention note.
Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203187|NCT01362686|P3|Participant Flow|Rivastigmine|"See intervention note.
Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203188|NCT01362686|P2|Participant Flow|Galantamine|"See intervention note.
Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203189|NCT01362686|P1|Participant Flow|Donepezil|"See intervention note.
Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203190|NCT01362686|O3|Outcome|Rivastigmine|"See intervention note.
Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203191|NCT01362686|O2|Outcome|Galantamine|"See intervention note.
Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203192|NCT01362686|O1|Outcome|Donepezil|"See intervention note.
Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203193|NCT01362686|O3|Outcome|Rivastigmine|"See intervention note.
Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203194|NCT01362686|O2|Outcome|Galantamine|"See intervention note.
Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203195|NCT01362686|O1|Outcome|Donepezil|"See intervention note.
Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203196|NCT01362686|O3|Outcome|Rivastigmine|"See intervention note.
Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203197|NCT01362686|O2|Outcome|Galantamine|"See intervention note.
Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203198|NCT01362686|O1|Outcome|Donepezil|"See intervention note.
Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
204985|NCT01357239|O1|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
203199|NCT01362686|E3|Reported Event|Rivastigmine|"See intervention note.
Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203200|NCT01362686|E2|Reported Event|Galantamine|"See intervention note.
Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203201|NCT01362686|E1|Reported Event|Donepezil|"See intervention note.
Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
203202|NCT01362608|B3|Baseline|Total|Total of all reporting groups
203203|NCT01362608|B2|Baseline|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203204|NCT01362608|B1|Baseline|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203205|NCT01362608|P2|Participant Flow|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203206|NCT01362608|P1|Participant Flow|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203207|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203208|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203209|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203210|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203211|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203212|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203213|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203214|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203215|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203216|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203217|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203218|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203219|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203220|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203221|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203222|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203223|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203224|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203225|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203226|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203227|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203228|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203229|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203230|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203231|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203232|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203233|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203234|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203235|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203236|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203237|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
203238|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
203239|NCT01362608|E2|Reported Event|Triam 40mg im|Triam 40mg im
203240|NCT01362608|E1|Reported Event|ACZ885 150mg sc|ACZ885 150mg sc
203242|NCT01362530|B2|Baseline|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203243|NCT01362530|B1|Baseline|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203244|NCT01362530|P2|Participant Flow|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203245|NCT01362530|P1|Participant Flow|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203246|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203247|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203248|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203249|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203250|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203251|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203252|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203253|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
203254|NCT01362530|E3|Reported Event|Aprepitant Regimen Cycles 2-6|Participants completing Cycle 1 from either the aprepitant or the control regimen who meet eligibility criteria: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
203255|NCT01362530|E2|Reported Event|Control Regimen Cycle 1|Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg).
203256|NCT01362530|E1|Reported Event|Aprepitant Regimen Cycle 1|Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
203257|NCT01362517|B1|Baseline|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at 2, 3 and 4 months of age"
203423|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203258|NCT01362517|P1|Participant Flow|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at 2, 3 and 4 months of age"
203259|NCT01362517|O1|Outcome|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at 2, 3 and 4 months of age"
203260|NCT01362517|O1|Outcome|Quinvaxem|
203261|NCT01362517|O1|Outcome|Quinvaxem|
203262|NCT01362517|E3|Reported Event|Third Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose given at 4 months of age"
203263|NCT01362517|E2|Reported Event|Second Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose given at 3 months of age"
203264|NCT01362517|E1|Reported Event|First Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose given at 2 months of age"
203265|NCT01362491|B4|Baseline|Total|Total of all reporting groups
203266|NCT01362491|B3|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203267|NCT01362491|B2|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203268|NCT01362491|B1|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203269|NCT01362491|P3|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203270|NCT01362491|P2|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203271|NCT01362491|P1|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203272|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203273|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203274|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203275|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203276|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203277|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203278|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203279|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203280|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203281|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203282|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203283|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203284|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203285|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203286|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203287|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203288|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203289|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203290|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203291|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203292|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203293|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203294|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203295|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203296|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203297|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203298|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203299|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203300|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203301|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203302|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203303|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203304|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203305|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203306|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203307|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203308|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203309|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203310|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203311|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203312|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203313|NCT01362491|O2|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203314|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
203315|NCT01362491|E3|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203316|NCT01362491|E2|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
203317|NCT01362491|E1|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
204986|NCT01357239|E4|Reported Event|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
203318|NCT01362439|B1|Baseline|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203319|NCT01362439|P1|Participant Flow|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203320|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203321|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203322|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203323|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203324|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203325|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203326|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203327|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203328|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203329|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203330|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203331|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203332|NCT01362439|E1|Reported Event|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
203333|NCT01362348|B1|Baseline|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203334|NCT01362348|P1|Participant Flow|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 micro liters ) of the pazopanib ophthalmic solution 10 milligram per millimeter (mg/mL) via topical ocular route to the study eye at approximate 5 hour intervals four times a day (QID) during the non-sleep period for a duration of 12 weeks.
203335|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203336|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203337|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203338|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203339|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203340|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203341|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203422|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
204987|NCT01357239|E3|Reported Event|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
203342|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203343|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203344|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203345|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203346|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203347|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203348|NCT01362348|O1|Outcome|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203349|NCT01362348|E1|Reported Event|Pazopanib 10 mg/mL QID|Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
203350|NCT01362296|B3|Baseline|Total|Total of all reporting groups
203351|NCT01362296|B2|Baseline|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203352|NCT01362296|B1|Baseline|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203353|NCT01362296|P4|Participant Flow|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203354|NCT01362296|P3|Participant Flow|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203355|NCT01362296|P2|Participant Flow|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203356|NCT01362296|P1|Participant Flow|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203357|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203358|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203359|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203375|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203360|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203361|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203362|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203363|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203364|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203365|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203366|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203367|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203368|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203369|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203370|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203371|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203372|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203373|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203374|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203420|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203376|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203377|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203378|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203379|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203380|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203381|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203382|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203383|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203384|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203385|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203386|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203387|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203388|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203389|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203390|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203421|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203391|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203392|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203393|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203394|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203395|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
203396|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
203397|NCT01362296|E4|Reported Event|Docetaxel 75 mg/m^2 in CP|Participants who experienced disease progression in the RP were given the option of crossing over to docetaxel 75 mg/m^2 and continuing in the CP.
203398|NCT01362296|E3|Reported Event|GSK1120212 2 mg in CP|Participants who experienced disease progression in the RP were given the option of crossing over to GSK1120212 2 mg and continuing in the Cross-over Phase (CP).
203399|NCT01362296|E2|Reported Event|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced.
203400|NCT01362296|E1|Reported Event|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced.
203401|NCT01362244|B3|Baseline|Total|Total of all reporting groups
203402|NCT01362244|B2|Baseline|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203403|NCT01362244|B1|Baseline|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion
203404|NCT01362244|P2|Participant Flow|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203405|NCT01362244|P1|Participant Flow|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203406|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203407|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203408|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203409|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203410|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203411|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203412|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203413|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203414|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203415|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203416|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203417|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203418|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203419|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203424|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203425|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203426|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203427|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203428|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203429|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203430|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203431|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203432|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203433|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203434|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203435|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203436|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203437|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203438|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203439|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203440|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203441|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203442|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203443|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203444|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203445|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203446|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203447|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203448|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203449|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203450|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203451|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203452|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203453|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203454|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203455|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203456|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203457|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203458|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203459|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203460|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203461|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203462|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203463|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203464|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203465|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203466|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203467|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203468|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203469|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203470|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203471|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203472|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
203473|NCT01362244|E2|Reported Event|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
203474|NCT01362244|E1|Reported Event|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion
203475|NCT01362205|B3|Baseline|Total|Total of all reporting groups
203476|NCT01362205|B2|Baseline|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203477|NCT01362205|B1|Baseline|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203478|NCT01362205|P2|Participant Flow|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203479|NCT01362205|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203480|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203481|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203482|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203483|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203484|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203485|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203486|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203487|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
205749|NCT01353976|P1|Participant Flow|Econazole Nitrate Foam 1%|Study medication
203488|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203489|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203490|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203491|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203492|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203493|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203494|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203495|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203496|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203497|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203498|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203499|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203500|NCT01362205|O2|Outcome|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203501|NCT01362205|O1|Outcome|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203502|NCT01362205|E2|Reported Event|Placebo|"Blinded placebo study drug administration in equal volume per hour as active study medication arm.
Placebo: Sterile, clear saline 0.9%"
203503|NCT01362205|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.
Dexmedetomidine: See arm details"
203504|NCT01362192|B1|Baseline|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
203505|NCT01362192|P1|Participant Flow|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
203506|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
203507|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
203508|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
203509|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
203510|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
203511|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
203512|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
203513|NCT01362192|E1|Reported Event|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
203514|NCT01362140|B3|Baseline|Total|Total of all reporting groups
203515|NCT01362140|B2|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203516|NCT01362140|B1|Baseline|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203517|NCT01362140|P2|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203518|NCT01362140|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203519|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203520|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203521|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203522|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203523|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203524|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203525|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203526|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203527|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203528|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203529|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203530|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203531|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203532|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203533|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203534|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203535|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203536|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203537|NCT01362140|E2|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
203538|NCT01362140|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
203539|NCT01362062|B3|Baseline|Total|Total of all reporting groups
203540|NCT01362062|B2|Baseline|RA Cohort (Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
203541|NCT01362062|B1|Baseline|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203542|NCT01362062|P2|Participant Flow|RA Cohort (Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
203543|NCT01362062|P1|Participant Flow|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic disease modifying anti-rheumatoid drug (DMARD) and/or anti-tumor necrosis factor (anti-TNF) therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203544|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203545|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203593|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
203546|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203547|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203548|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203549|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203550|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203551|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203552|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203553|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203554|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203555|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203556|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
203557|NCT01362062|O1|Outcome|RA Cohort (Prospective + Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
203558|NCT01362062|E1|Reported Event|RA Cohort (Prospective + Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
203559|NCT01362049|B5|Baseline|Total|Total of all reporting groups
203560|NCT01362049|B4|Baseline|'Ineligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.
Received STAB treatment"
203561|NCT01362049|B3|Baseline|'Ineligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.
Received MSI-match treatment"
203562|NCT01362049|B2|Baseline|'Eligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
203563|NCT01362049|B1|Baseline|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI-match treatment"
203564|NCT01362049|P4|Participant Flow|'Ineligible' Subject Group – STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.
Received STAB treatment"
203565|NCT01362049|P3|Participant Flow|'Ineligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.
Received MSI- matched treatment"
203566|NCT01362049|P2|Participant Flow|'Eligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
203698|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203567|NCT01362049|P1|Participant Flow|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI match treatment"
203568|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203569|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
203570|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203571|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises
203572|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203573|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
203574|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203575|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
203576|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203577|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises
203578|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203579|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises
203661|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203580|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203581|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises
203582|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203583|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
203584|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203585|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
203586|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203587|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
203588|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203589|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
203590|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203591|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises
203592|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203594|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203595|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
203596|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203597|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
203598|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
203599|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
203600|NCT01362049|E4|Reported Event|'Ineligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.
Received STAB treatment"
203601|NCT01362049|E3|Reported Event|'Ineligible' Subject Group - MSI Treatment|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Received MSI-matched treatment
203602|NCT01362049|E2|Reported Event|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
203603|NCT01362049|E1|Reported Event|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
straight leg raise > 90 degrees
aberrant trunk movement with trunk forward flexion
positive prone instability test AND/OR
passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI-matched treatment"
203604|NCT01361867|B1|Baseline|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.
Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
203605|NCT01361867|P1|Participant Flow|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.
Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
203606|NCT01361867|O1|Outcome|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.
Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
203607|NCT01361867|O1|Outcome|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.
Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
203608|NCT01361867|E1|Reported Event|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.
Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
203609|NCT01361854|B1|Baseline|Polysomnography for Suspicion of SDB|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography: home-based polysomnography with hook-up performed ar at home or in the hospital"
203610|NCT01361854|P2|Participant Flow|Hospital Hook-up First, Then Home Hook-up|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography: home-based polysomnography with hook-up performed at the hospital Croosover design. 2nd polysomnography with home hook-up performed within 2 weeks"
203611|NCT01361854|P1|Participant Flow|Home Hook-up First Then Hook-up in the Hospital|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography: home-based polysomnography with hook-up performed at home first.
Croosover design. 2nd polysomnography with in-lab hook-up performed within 2 weeks"
203612|NCT01361854|O2|Outcome|Lab Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography:home polysomnography with in-lab hook up first"
203613|NCT01361854|O1|Outcome|Home Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography: home-based polysomnography with home hook-up first"
203614|NCT01361854|E2|Reported Event|Lab Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography: home-based polysomnography with hook-up performed in the sleep lab"
203615|NCT01361854|E1|Reported Event|Home Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography: home-based polysomnography with hook-up performed at home"
203616|NCT01360645|B3|Baseline|Total|Total of all reporting groups
203617|NCT01360645|B2|Baseline|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203618|NCT01360645|B1|Baseline|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203619|NCT01360645|P4|Participant Flow|Phase A+ Placebo + ADT|Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+
203620|NCT01360645|P3|Participant Flow|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203621|NCT01360645|P2|Participant Flow|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203622|NCT01360645|P1|Participant Flow|Single-blind Placebo + ADT|In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks
203623|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203624|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203625|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203626|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203627|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203628|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203629|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203630|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203631|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203632|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203633|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203634|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203635|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203697|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
205750|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
203636|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203637|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203638|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203639|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203640|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203641|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203642|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203643|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203644|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203645|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203646|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203647|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203648|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203649|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203650|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203651|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203652|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203653|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203654|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203655|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203656|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203657|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203658|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203659|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203660|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203662|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203663|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203664|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203665|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203666|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203667|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203668|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203669|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203670|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203671|NCT01360645|E2|Reported Event|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203672|NCT01360645|E1|Reported Event|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
203673|NCT01360632|B4|Baseline|Total|Total of all reporting groups
203674|NCT01360632|B3|Baseline|Placebo + ADT|Participants were administered placebo as an adjunctive therapy to an open label ADT.
203675|NCT01360632|B2|Baseline|Brexpiprazole (3mg + ADT)|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
203676|NCT01360632|B1|Baseline|Brexpiprazole (1mg + ADT)|Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.
203677|NCT01360632|P5|Participant Flow|Phase A+ Placebo + ADT|Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+
203678|NCT01360632|P4|Participant Flow|Double-blind Placebo + ADT|In phase B, participants were administered placebo as an adjunctive therapy to an open label ADT for 6 weeks.
203679|NCT01360632|P3|Participant Flow|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
203680|NCT01360632|P2|Participant Flow|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole of [1mg (milligram)] as an adjunctive therapy to an assigned open-label ADT (anti-depressant therapy).
203681|NCT01360632|P1|Participant Flow|Single-blind Placebo + ADT|In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks.
203682|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203683|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203684|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203685|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203686|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203687|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203688|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203689|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203690|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203691|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203692|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203693|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203694|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203695|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203696|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203699|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203700|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203701|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203702|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203703|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203704|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203705|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203706|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203707|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203708|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203709|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203710|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203711|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203712|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203713|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203714|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203715|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203716|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203717|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203718|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203719|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203720|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203721|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203722|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203723|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203724|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203725|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203726|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203727|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203728|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203729|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203730|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203731|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203732|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203733|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203734|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203735|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203736|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203737|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203738|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203739|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203740|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203741|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203742|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203743|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203744|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203745|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203746|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203747|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203748|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203749|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203750|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203751|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
203752|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
203753|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
203754|NCT01360632|E3|Reported Event|Placebo + ADT|Participants were administered placebo as an adjunctive therapy to an open label ADT.
203755|NCT01360632|E2|Reported Event|Brexpiprazole (3mg + ADT)|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
203756|NCT01360632|E1|Reported Event|Brexpiprazole (1mg + ADT)|Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.
203757|NCT01360554|B3|Baseline|Total|Total of all reporting groups
203758|NCT01360554|B2|Baseline|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203759|NCT01360554|B1|Baseline|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203760|NCT01360554|P2|Participant Flow|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203761|NCT01360554|P1|Participant Flow|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203762|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203763|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203764|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203765|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203766|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203767|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203768|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203769|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203827|NCT01361568|P6|Participant Flow|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
205751|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
203770|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203771|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203772|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203773|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203774|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203775|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203776|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203777|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203778|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203779|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203780|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203781|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203782|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203783|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203784|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203785|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203786|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203787|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203788|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203789|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203790|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203791|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203792|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203793|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203794|NCT01360554|E2|Reported Event|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203795|NCT01360554|E1|Reported Event|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
203796|NCT01361633|B3|Baseline|Total|Total of all reporting groups
203797|NCT01361633|B2|Baseline|Sugar Pill|Placebo Control
203798|NCT01361633|B1|Baseline|Medication|250 mg d-cycloserine
203799|NCT01361633|P2|Participant Flow|Sugar Pill|Placebo Control
203800|NCT01361633|P1|Participant Flow|Medication|250 mg d-cycloserine
203801|NCT01361633|O2|Outcome|Sugar Pill|Placebo control
203802|NCT01361633|O1|Outcome|Medication|250mg d-cycloserine
203803|NCT01361633|E2|Reported Event|Sugar Pill|Placebo Control
203804|NCT01361633|E1|Reported Event|Medication|250 mg d-cycloserine
203805|NCT01361620|B1|Baseline|Aspirin|All subjects took 7-10 days of 81 mg aspirin
203806|NCT01361620|P1|Participant Flow|Aspirin|All subjects took 7-10 days of 81 mg aspirin
203807|NCT01361620|O1|Outcome|Aspirin|All subjects took 7-10 days of 81 mg aspirin
203808|NCT01361620|E1|Reported Event|Aspirin|All subjects took 7-10 days of 81 mg aspirin
203809|NCT01361594|B3|Baseline|Total|Total of all reporting groups
203810|NCT01361594|B2|Baseline|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)
Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
203811|NCT01361594|B1|Baseline|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)
Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
203812|NCT01361594|P2|Participant Flow|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)
Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
203813|NCT01361594|P1|Participant Flow|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)
Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
203814|NCT01361594|O2|Outcome|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)
Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
203815|NCT01361594|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)
Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
203816|NCT01361594|O2|Outcome|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)
Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
203817|NCT01361594|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)
Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
203818|NCT01361594|E2|Reported Event|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)
Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
203819|NCT01361594|E1|Reported Event|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)
Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
203820|NCT01361568|B7|Baseline|Total|Total of all reporting groups
203821|NCT01361568|B6|Baseline|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
203822|NCT01361568|B5|Baseline|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
203823|NCT01361568|B4|Baseline|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
203824|NCT01361568|B3|Baseline|CR845-CR845|CR845 administered both preoperatively and postoperatively
203825|NCT01361568|B2|Baseline|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
203826|NCT01361568|B1|Baseline|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
203972|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10"
203828|NCT01361568|P5|Participant Flow|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
203829|NCT01361568|P4|Participant Flow|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
203830|NCT01361568|P3|Participant Flow|CR845-CR845|CR845 administered both preoperatively and postoperatively
203831|NCT01361568|P2|Participant Flow|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
203832|NCT01361568|P1|Participant Flow|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
203833|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
203834|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only, either preoperatively and/or postoperatively
203835|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
203836|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only, either preoperatively and/or postoperatively
203837|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
203838|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only either preoperatively and/or postoperatively
203839|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
203840|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
203841|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
203842|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
203843|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
203844|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
203845|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
203846|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
203847|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
203848|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
203849|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
203850|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
203851|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
203852|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
203853|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
203854|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
203855|NCT01361568|E6|Reported Event|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
203856|NCT01361568|E5|Reported Event|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
203857|NCT01361568|E4|Reported Event|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
203858|NCT01361568|E3|Reported Event|CR845-CR845|CR845 administered both preoperatively and postoperatively
203859|NCT01361568|E2|Reported Event|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
203860|NCT01361568|E1|Reported Event|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
203861|NCT01361464|B1|Baseline|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
203862|NCT01361464|P1|Participant Flow|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
203863|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
203864|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
203865|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
203866|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
203867|NCT01361464|E1|Reported Event|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
203868|NCT01361308|B3|Baseline|Total|Total of all reporting groups
203869|NCT01361308|B2|Baseline|Placebo Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203870|NCT01361308|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203871|NCT01361308|P2|Participant Flow|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203872|NCT01361308|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203873|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
204046|NCT01360021|P3|Participant Flow|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
205752|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
203874|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203875|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203876|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203877|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203878|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203879|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203880|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203881|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203882|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203883|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203884|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203885|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203886|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203887|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203888|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203889|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203890|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203891|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203892|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203893|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203894|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203895|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203896|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203897|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203898|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203899|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203900|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203901|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203902|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203903|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203904|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203905|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203906|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203907|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203908|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
203909|NCT01361308|E2|Reported Event|Placebo Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203910|NCT01361308|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
203911|NCT01361178|B3|Baseline|Total|Total of all reporting groups
203912|NCT01361178|B2|Baseline|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.
SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
203913|NCT01361178|B1|Baseline|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
203914|NCT01361178|P2|Participant Flow|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.
SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
203915|NCT01361178|P1|Participant Flow|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
203916|NCT01361178|O2|Outcome|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.
SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
203917|NCT01361178|O1|Outcome|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
203918|NCT01361178|E2|Reported Event|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.
SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
203919|NCT01361178|E1|Reported Event|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
203920|NCT01361126|B3|Baseline|Total|Total of all reporting groups
203921|NCT01361126|B2|Baseline|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered 1 or more IV infusions of rIX-FP at a dose of at least 25 IU/kg to treat minor, moderate or major bleeding episodes. The dose of rIX-FP was calculated by the investigator.
203922|NCT01361126|B1|Baseline|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
203923|NCT01361126|P2|Participant Flow|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered 1 or more IV infusions of rIX-FP at a dose of at least 25 IU/kg to treat minor, moderate or major bleeding episodes. The dose of rIX-FP was calculated by the investigator.
203924|NCT01361126|P1|Participant Flow|Prophylactic|For the PK evaluation, subjects received a single intravenous (IV) infusion of Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
203925|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
203926|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
203927|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
203928|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
203929|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
203930|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
203931|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
203932|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
203933|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
203934|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
203935|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
203936|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
203937|NCT01361126|E1|Reported Event|All Subjects|Subjects received rIX-FP administered by IV infusion as prophylactic treatment once a week or on demand to treat bleeding episodes for 20 weeks.
203938|NCT01361113|B1|Baseline|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
203939|NCT01361113|P1|Participant Flow|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
203940|NCT01361113|O1|Outcome|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
203941|NCT01361113|O1|Outcome|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
203942|NCT01361113|E1|Reported Event|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
203943|NCT01361048|B4|Baseline|Total|Total of all reporting groups
203944|NCT01361048|B3|Baseline|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
203945|NCT01361048|B2|Baseline|Neo Penotran Forte Twice a Day|neo penotran forte vaginal suppository twice a day for 7 days
203946|NCT01361048|B1|Baseline|Oral Metronidazole|control arm
203947|NCT01361048|P3|Participant Flow|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
203948|NCT01361048|P2|Participant Flow|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
203949|NCT01361048|P1|Participant Flow|Oral Metronidazole|control arm
203950|NCT01361048|O3|Outcome|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
203951|NCT01361048|O2|Outcome|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
203952|NCT01361048|O1|Outcome|Oral Metronidazole 2 gm Stat Dose|control arm
203953|NCT01361048|E3|Reported Event|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
203954|NCT01361048|E2|Reported Event|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
203955|NCT01361048|E1|Reported Event|Oral Metronidazole|control arm
203956|NCT01361009|B1|Baseline|Pramipexole Goup|
203957|NCT01361009|P1|Participant Flow|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
203958|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
203959|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
203960|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
203961|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
203962|NCT01361009|E1|Reported Event|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
203963|NCT01360996|B4|Baseline|Total|Total of all reporting groups
203964|NCT01360996|B3|Baseline|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 30-34.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
203965|NCT01360996|B2|Baseline|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 25-29.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
203966|NCT01360996|B1|Baseline|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
Normal weight -BMI 18-24.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
203967|NCT01360996|P3|Participant Flow|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 30-34.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
203968|NCT01360996|P2|Participant Flow|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 25-29.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
203969|NCT01360996|P1|Participant Flow|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
Normal weight -BMI 18-24.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
203970|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10"
203971|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2"
203973|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2"
203974|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10"
203975|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2"
203976|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10"
203977|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2"
203978|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10"
203979|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2"
203980|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10"
203981|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2"
203982|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10"
203983|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2"
203984|NCT01360996|E3|Reported Event|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 30-34.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
203985|NCT01360996|E2|Reported Event|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 25-29.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
203986|NCT01360996|E1|Reported Event|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
Normal weight -BMI 18-24.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
203987|NCT01360840|B4|Baseline|Total|Total of all reporting groups
203988|NCT01360840|B3|Baseline|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
203989|NCT01360840|B2|Baseline|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
203990|NCT01360840|B1|Baseline|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
203991|NCT01360840|P3|Participant Flow|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
203992|NCT01360840|P2|Participant Flow|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
203993|NCT01360840|P1|Participant Flow|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the standard of care (SoC) consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204047|NCT01360021|P2|Participant Flow|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
204048|NCT01360021|P1|Participant Flow|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
204049|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
204050|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
203994|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
203995|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
203996|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
203997|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
203998|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
203999|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204000|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204001|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204002|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204003|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204004|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204005|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204051|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
204052|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
204053|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
204054|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
204006|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204007|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204008|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204009|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204010|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204011|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204012|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204013|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204014|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204015|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204016|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204017|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204055|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
204056|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
204057|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
204058|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
204059|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
204018|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204019|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204020|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204021|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204022|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204023|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204024|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204025|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204026|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204027|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204028|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204029|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204060|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
204061|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
204062|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
204063|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
204064|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
204030|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204031|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204032|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204033|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204034|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204035|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204036|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204037|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204038|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204039|NCT01360840|E3|Reported Event|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204040|NCT01360840|E2|Reported Event|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 milligram (mg) (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204041|NCT01360840|E1|Reported Event|Placebo + SoC|Subjects were administered with placebo 0.9 percent (%) sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
204042|NCT01360021|B4|Baseline|Total|Total of all reporting groups
204043|NCT01360021|B3|Baseline|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
204044|NCT01360021|B2|Baseline|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
204045|NCT01360021|B1|Baseline|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
204071|NCT01359943|B3|Baseline|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204072|NCT01359943|B2|Baseline|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204073|NCT01359943|B1|Baseline|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204074|NCT01359943|P3|Participant Flow|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204075|NCT01359943|P2|Participant Flow|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204076|NCT01359943|P1|Participant Flow|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204077|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204078|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204079|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204080|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204081|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204082|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204083|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204084|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204085|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204086|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204087|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204088|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204089|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204090|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204091|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204092|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204093|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204094|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204095|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204096|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204097|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204098|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204099|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204100|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204101|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204102|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204103|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204104|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204172|NCT01359644|B7|Baseline|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype1 a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks..
204105|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204106|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204107|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204108|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204109|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204110|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204111|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204112|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204113|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204114|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204115|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204116|NCT01359943|E5|Reported Event|AIN457 Pooled Treatment Groups - Follow-up Period|Follow-up period: week 52 through week 60 - AIN457 150 mg sc open label
204117|NCT01359943|E4|Reported Event|AIN457 Pooled Treatment Groups - Open Label Period|Week 16 through week 52: AIN457 150 mg s.c. open label
204118|NCT01359943|E3|Reported Event|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
204119|NCT01359943|E2|Reported Event|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204120|NCT01359943|E1|Reported Event|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
204121|NCT01359904|B3|Baseline|Total|Total of all reporting groups
204122|NCT01359904|B2|Baseline|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
204123|NCT01359904|B1|Baseline|High Dialysate Bath|additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
204124|NCT01359904|P2|Participant Flow|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
204125|NCT01359904|P1|Participant Flow|High Dialysate Bath|additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
204126|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
204127|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
204128|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
204129|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
204130|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
204131|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
204132|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
204133|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
204134|NCT01359904|E2|Reported Event|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
204135|NCT01359904|E1|Reported Event|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
204136|NCT01359748|B5|Baseline|Total|Total of all reporting groups
204137|NCT01359748|B4|Baseline|Wrist Size >=17.75|Subjects, males or females, with wrist size specified.
204138|NCT01359748|B3|Baseline|Wrist Size >=16.5 Cm|Subjects, males or females, with wrist size specified.
204139|NCT01359748|B2|Baseline|Wrist Size<=16.40 Cm|Subjects, males or females, with wrist size specified.
204140|NCT01359748|B1|Baseline|Wrist Size <=14.25Cm|Subjects, males or females, with wrist size specified.
204141|NCT01359748|P4|Participant Flow|Subjects With Wrist Size >=17.75Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.
The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
204173|NCT01359644|B6|Baseline|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
204142|NCT01359748|P3|Participant Flow|Subjects With Wrist Size >=16.50Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.
The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
204143|NCT01359748|P2|Participant Flow|Subjects With Wrist Size <=14.25Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.
The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
204144|NCT01359748|P1|Participant Flow|Subjects With Wrist Size >=14.26Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.
The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
204145|NCT01359748|O1|Outcome|Subjects|Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
204146|NCT01359748|O1|Outcome|Subjects|Subjects who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
204147|NCT01359748|E4|Reported Event|Wrist Size >=17.75 Cm|Subjects with wrist size equal or higher than 17.75 Cm
204148|NCT01359748|E3|Reported Event|Wrist Size >=16.5 Cm|Subjects with wrist size equal or higher than 16.5 Cm
204149|NCT01359748|E2|Reported Event|Wrist Size <=16.4Cm|Subjects with wrist size equal or less than 16.40 Cm
204150|NCT01359748|E1|Reported Event|Wrist Size <=14.25 Cm|Subjects with wrist size equal or less than 14.25 Cm
204151|NCT01359735|B3|Baseline|Total|Total of all reporting groups
204152|NCT01359735|B2|Baseline|Bacitracin Ointment|"bacitracin antibiotic ointment
Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
204153|NCT01359735|B1|Baseline|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly
HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
204154|NCT01359735|P2|Participant Flow|Bacitracin Ointment|"bacitracin antibiotic ointment
Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
204155|NCT01359735|P1|Participant Flow|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly
HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
204156|NCT01359735|O2|Outcome|Bacitracin Ointment|"bacitracin antibiotic ointment
Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
204157|NCT01359735|O1|Outcome|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly
HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
204158|NCT01359735|O2|Outcome|Bacitracin Ointment|"bacitracin antibiotic ointment
Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
204159|NCT01359735|O1|Outcome|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly
HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
204160|NCT01359735|O2|Outcome|Bacitracin Ointment|"bacitracin antibiotic ointment
Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
204161|NCT01359735|O1|Outcome|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly
HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
204162|NCT01359735|O2|Outcome|Bacitracin Ointment|"bacitracin antibiotic ointment
Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
204163|NCT01359735|O1|Outcome|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly
HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
204164|NCT01359735|O2|Outcome|Bacitracin Ointment|"bacitracin antibiotic ointment
Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
204165|NCT01359735|O1|Outcome|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly
HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
204166|NCT01359735|E2|Reported Event|Bacitracin Ointment|"bacitracin antibiotic ointment
Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed)."
204167|NCT01359735|E1|Reported Event|HP802-247|"allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly
HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed"
204168|NCT01359644|B11|Baseline|Total|Total of all reporting groups
204169|NCT01359644|B10|Baseline|Treatment J: Sofosbuvir +Daclatasvir +Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavarin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg) and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
204170|NCT01359644|B9|Baseline|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily and daclatasvir, 60 mg, once daily for 24 weeks.
204171|NCT01359644|B8|Baseline|Treatment H: Sofosbuvir +Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
204174|NCT01359644|B5|Baseline|Treatment E: Sofosbuvir +Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
204175|NCT01359644|B4|Baseline|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype-2 or -3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks..
204176|NCT01359644|B3|Baseline|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
204177|NCT01359644|B2|Baseline|Treatment: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
204178|NCT01359644|B1|Baseline|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus genotype 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
204179|NCT01359644|P10|Participant Flow|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
204180|NCT01359644|P9|Participant Flow|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
204181|NCT01359644|P8|Participant Flow|Treatment H : Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
204182|NCT01359644|P7|Participant Flow|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
204183|NCT01359644|P6|Participant Flow|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
204184|NCT01359644|P5|Participant Flow|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
204185|NCT01359644|P4|Participant Flow|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
204186|NCT01359644|P3|Participant Flow|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
204187|NCT01359644|P2|Participant Flow|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
204188|NCT01359644|P1|Participant Flow|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
204189|NCT01359644|O4|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
204190|NCT01359644|O3|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
204191|NCT01359644|O2|Outcome|Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks.
204192|NCT01359644|O1|Outcome|Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
204193|NCT01359644|O4|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
204194|NCT01359644|O3|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
204195|NCT01359644|O2|Outcome|Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks.
204196|NCT01359644|O1|Outcome|Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
204197|NCT01359644|O10|Outcome|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
204198|NCT01359644|O9|Outcome|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
204199|NCT01359644|O8|Outcome|Treatment H: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
204200|NCT01359644|O7|Outcome|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
204201|NCT01359644|O6|Outcome|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
204202|NCT01359644|O5|Outcome|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
204203|NCT01359644|O4|Outcome|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
204204|NCT01359644|O3|Outcome|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
204205|NCT01359644|O2|Outcome|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
204206|NCT01359644|O1|Outcome|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus genotypes 1a or 1b received sofosbuvir, 400 mg, once daily) for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
204207|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
204208|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
204209|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
204210|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
204211|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
204212|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
204213|NCT01359644|O3|Outcome|Telaprevir/Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
204214|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
204215|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir 400 mg tablets + daclatasvir 60 mg tablets ± ribavirin (a total daily dose of 1000 mg/1200mg) tablets once daily for 12 or 24 weeks.
204216|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
204217|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
204218|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
204219|NCT01359644|E10|Reported Event|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
205753|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
204220|NCT01359644|E9|Reported Event|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
204221|NCT01359644|E8|Reported Event|Treatment H : Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
204222|NCT01359644|E7|Reported Event|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
204223|NCT01359644|E6|Reported Event|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks
204224|NCT01359644|E5|Reported Event|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
204225|NCT01359644|E4|Reported Event|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
204226|NCT01359644|E3|Reported Event|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
204227|NCT01359644|E2|Reported Event|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks
204228|NCT01359644|E1|Reported Event|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
204229|NCT01359449|B3|Baseline|Total|Total of all reporting groups
204230|NCT01359449|B2|Baseline|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204231|NCT01359449|B1|Baseline|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204232|NCT01359449|P2|Participant Flow|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204233|NCT01359449|P1|Participant Flow|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204234|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204235|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204236|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204237|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204238|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204239|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204240|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204241|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204242|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204243|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204244|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204245|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204246|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204432|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204247|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204248|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204249|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204250|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204251|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204252|NCT01359449|E2|Reported Event|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
204253|NCT01359449|E1|Reported Event|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
204254|NCT01359410|B3|Baseline|Total|Total of all reporting groups
204255|NCT01359410|B2|Baseline|Stapled Transection Without Mesh Reinforcement|
204256|NCT01359410|B1|Baseline|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
204257|NCT01359410|P2|Participant Flow|Stapled Transection Without Mesh Reinforcement|
204258|NCT01359410|P1|Participant Flow|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
204259|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
204260|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
204261|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
204262|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
204263|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
204264|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
204265|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
204266|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
204267|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
204268|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
204269|NCT01359410|E2|Reported Event|Stapled Transection Without Mesh Reinforcement|
204270|NCT01359410|E1|Reported Event|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
204271|NCT01359371|B1|Baseline|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
204272|NCT01359371|P1|Participant Flow|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
204273|NCT01359371|O2|Outcome|Number of Times Reached for Peer Telephone Counseling:3-4times|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital. This group was reached 3-4 times for peer telephone counseling.
204274|NCT01359371|O1|Outcome|Number of Times Reached for Peer Telephone Counseling:0-2times|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital. This group was reached 0-2 times for peer telephone counseling.
204275|NCT01359371|E1|Reported Event|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
204276|NCT01359254|B3|Baseline|Total|Total of all reporting groups
204277|NCT01359254|B2|Baseline|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
Busulfan: Busulfan is given daily for 4 days.
Total Body Irradiation (TBI): TBI is given twice on the last day."
204278|NCT01359254|B1|Baseline|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
204279|NCT01359254|P2|Participant Flow|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
Busulfan: Busulfan is given daily for 4 days.
Total Body Irradiation (TBI): TBI is given twice on the last day."
204280|NCT01359254|P1|Participant Flow|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
204281|NCT01359254|O2|Outcome|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
Busulfan: Busulfan is given daily for 4 days.
Total Body Irradiation (TBI): TBI is given twice on the last day."
205754|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
204282|NCT01359254|O1|Outcome|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
204283|NCT01359254|O2|Outcome|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
Busulfan: Busulfan is given daily for 4 days.
Total Body Irradiation (TBI): TBI is given twice on the last day."
204284|NCT01359254|O1|Outcome|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
204285|NCT01359254|E2|Reported Event|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
Busulfan: Busulfan is given daily for 4 days.
Total Body Irradiation (TBI): TBI is given twice on the last day."
204286|NCT01359254|E1|Reported Event|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
204287|NCT01359150|B3|Baseline|Total|Total of all reporting groups
204288|NCT01359150|B2|Baseline|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204289|NCT01359150|B1|Baseline|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204290|NCT01359150|P2|Participant Flow|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204291|NCT01359150|P1|Participant Flow|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204292|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204293|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204294|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204295|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204296|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204297|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204298|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204299|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204300|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204301|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204302|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204683|NCT01357980|B3|Baseline|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204303|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204304|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204305|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204306|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204307|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204308|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204309|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204310|NCT01359150|E2|Reported Event|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204311|NCT01359150|E1|Reported Event|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
204312|NCT01359111|B1|Baseline|Intradermal Adapter|Saline injection with intradermal adapter
204313|NCT01359111|P1|Participant Flow|Intradermal Adapter|Saline injection with intradermal adapter
204314|NCT01359111|O2|Outcome|Bevel Down|Saline injection with intradermal adapter used with needle bevel oriented down relative to the surface of the skin
204315|NCT01359111|O1|Outcome|Bevel Up|Saline injection with intradermal adapter used with needle bevel oriented up relative to the surface of the skin
204316|NCT01359111|O1|Outcome|Intradermal Adapter|Saline injection with intradermal adapter
204317|NCT01359111|O1|Outcome|Intradermal Adapter|Saline injection with intradermal adapter
204318|NCT01359111|E1|Reported Event|Intradermal Adapter|Saline injection with intradermal adapter
204319|NCT01358864|B9|Baseline|Total|Total of all reporting groups
204320|NCT01358864|B8|Baseline|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204321|NCT01358864|B7|Baseline|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204322|NCT01358864|B6|Baseline|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204323|NCT01358864|B5|Baseline|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204324|NCT01358864|B4|Baseline|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204325|NCT01358864|B3|Baseline|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204326|NCT01358864|B2|Baseline|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204327|NCT01358864|B1|Baseline|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204328|NCT01358864|P8|Participant Flow|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
205755|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
204329|NCT01358864|P7|Participant Flow|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204330|NCT01358864|P6|Participant Flow|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204331|NCT01358864|P5|Participant Flow|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204332|NCT01358864|P4|Participant Flow|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204333|NCT01358864|P3|Participant Flow|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204334|NCT01358864|P2|Participant Flow|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir (BI 201335) 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204335|NCT01358864|P1|Participant Flow|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204336|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204337|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204338|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204339|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204340|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204341|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204342|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204343|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204344|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204345|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204346|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204347|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204348|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204684|NCT01357980|B2|Baseline|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204349|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204350|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204351|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204352|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204353|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204354|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204355|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204356|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204357|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204358|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204359|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204360|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204361|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204362|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204363|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204364|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204365|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204366|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204367|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204368|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204685|NCT01357980|B1|Baseline|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204369|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204370|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204371|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204372|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204373|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204374|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204375|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204376|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204377|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204378|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204379|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204380|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204381|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204382|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204383|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204384|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204385|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204386|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204387|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204388|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204433|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
204389|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204390|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204391|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204392|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204393|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204394|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204395|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204396|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204397|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204398|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204399|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204400|NCT01358864|O5|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204401|NCT01358864|O4|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204402|NCT01358864|O3|Outcome|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
204403|NCT01358864|O2|Outcome|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
204404|NCT01358864|O1|Outcome|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204405|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204406|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204407|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204408|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204409|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204410|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204411|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
204412|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204413|NCT01358864|O5|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204414|NCT01358864|O4|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204415|NCT01358864|O3|Outcome|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
204416|NCT01358864|O2|Outcome|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
204417|NCT01358864|O1|Outcome|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204418|NCT01358864|E5|Reported Event|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204419|NCT01358864|E4|Reported Event|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
204420|NCT01358864|E3|Reported Event|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
204421|NCT01358864|E2|Reported Event|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
204422|NCT01358864|E1|Reported Event|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
204423|NCT01358825|B3|Baseline|Total|Total of all reporting groups
204424|NCT01358825|B2|Baseline|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
204425|NCT01358825|B1|Baseline|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204426|NCT01358825|P2|Participant Flow|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
204427|NCT01358825|P1|Participant Flow|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204428|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204429|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
204430|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204431|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
204434|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204435|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204436|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204437|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
204438|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204439|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
204440|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204441|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
204442|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204443|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
204444|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204445|NCT01358825|E2|Reported Event|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
204446|NCT01358825|E1|Reported Event|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
204447|NCT01358760|B4|Baseline|Total|Total of all reporting groups
204448|NCT01358760|B3|Baseline|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204449|NCT01358760|B2|Baseline|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204450|NCT01358760|B1|Baseline|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204451|NCT01358760|P3|Participant Flow|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204452|NCT01358760|P2|Participant Flow|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204453|NCT01358760|P1|Participant Flow|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204454|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204455|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204456|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204457|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204458|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204459|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204460|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204461|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204462|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204463|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204464|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204465|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204466|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204467|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204468|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204469|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204470|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204471|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204472|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204473|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204474|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204475|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204476|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204477|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204478|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204479|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204480|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204481|NCT01358760|E3|Reported Event|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204482|NCT01358760|E2|Reported Event|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204483|NCT01358760|E1|Reported Event|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
204484|NCT01358734|B4|Baseline|Total|Total of all reporting groups
204485|NCT01358734|B3|Baseline|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
204486|NCT01358734|B2|Baseline|Azacitidine + Lenalidomide|Azacitidine 75 mg/m^2/ daily subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg daily PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
204487|NCT01358734|B1|Baseline|Lenalidomide|Lenalidomide 50 mg/day by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg daily PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily
204488|NCT01358734|P3|Participant Flow|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
204489|NCT01358734|P2|Participant Flow|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
204490|NCT01358734|P1|Participant Flow|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
204491|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
204492|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
204493|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
204494|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
204495|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
204496|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
204497|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
204498|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
204499|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
204500|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
204501|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
204502|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
204503|NCT01358734|E3|Reported Event|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
204504|NCT01358734|E2|Reported Event|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
204505|NCT01358734|E1|Reported Event|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
204506|NCT01358708|B3|Baseline|Total|Total of all reporting groups
204507|NCT01358708|B2|Baseline|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204508|NCT01358708|B1|Baseline|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204509|NCT01358708|P2|Participant Flow|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204510|NCT01358708|P1|Participant Flow|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204511|NCT01358708|O3|Outcome|LACTEOL® 340 mg Open-Label Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204512|NCT01358708|O2|Outcome|PLACEBO Double-Blind Period|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204513|NCT01358708|O1|Outcome|LACTEOL® 340 mg Double-Blind Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204514|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204515|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204516|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204517|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204518|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204519|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204520|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204521|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204522|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204523|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204524|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204525|NCT01358708|E3|Reported Event|LACTEOL® 340 mg Open-Label Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204526|NCT01358708|E2|Reported Event|PLACEBO Double-Blind Period|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204527|NCT01358708|E1|Reported Event|LACTEOL® 340 mg Double-Blind Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
204528|NCT01358578|B5|Baseline|Total|Total of all reporting groups
204529|NCT01358578|B4|Baseline|Etanercept|Etanercept
204530|NCT01358578|B3|Baseline|Placebo|Placebo
204531|NCT01358578|B2|Baseline|AIN457 300mg|AIN457 300mg
204532|NCT01358578|B1|Baseline|AIN457 150mg|AIN457 150mg
204533|NCT01358578|P6|Participant Flow|AIN457 300mg From Placebo|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
204534|NCT01358578|P5|Participant Flow|AIN457 150mg From Placebo|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
204535|NCT01358578|P4|Participant Flow|Etanercept|"Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.
injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab."
204595|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours"
204686|NCT01357980|P4|Participant Flow|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204536|NCT01358578|P3|Participant Flow|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
204537|NCT01358578|P2|Participant Flow|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204538|NCT01358578|P1|Participant Flow|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204539|NCT01358578|O6|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
204540|NCT01358578|O5|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
204541|NCT01358578|O4|Outcome|PLACEBO-300 mg AIN457|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
204542|NCT01358578|O3|Outcome|PLACEBO-150 mg AIN457|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
204543|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204544|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204545|NCT01358578|O3|Outcome|Etanercept|etanercept 50 mg twice per week until Week 12
204546|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204547|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204548|NCT01358578|O3|Outcome|Placebo|AIN457A exact match Placebo
204549|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204550|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204551|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
204552|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204553|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204554|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
204555|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204556|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204557|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
204558|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204559|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204640|NCT01358357|E3|Reported Event|All Subjects|During the open-label stabilization phase, subjects received flexible does of lurasidone 20-80 mg daily
204560|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
204561|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204562|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204563|NCT01358578|O4|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
204564|NCT01358578|O3|Outcome|Etanercept|"Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.
injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab."
204565|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204566|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204567|NCT01358578|O3|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
204568|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204569|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204570|NCT01358578|O3|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
204571|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204572|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
204573|NCT01358578|E14|Reported Event|FOLLOW UP-Etanercept|FOLLOW UP-Etanercept
204574|NCT01358578|E13|Reported Event|FOLLOW UP-Placebo|FOLLOW UP-Placebo
204575|NCT01358578|E12|Reported Event|FOLLOW UP-Any AIN457 300mg|FOLLOW UP-Any AIN457 300mg
204576|NCT01358578|E11|Reported Event|FOLLOW UP-Any AIN457 150mg|FOLLOW UP-Any AIN457 150mg
204577|NCT01358578|E10|Reported Event|ENTIRE-Etanercept|ENTIRE-Etanercept
204578|NCT01358578|E9|Reported Event|ENTIRE-Placebo|ENTIRE-Placebo
204579|NCT01358578|E8|Reported Event|ENTIRE-Any AIN457 300mg|ENTIRE-Any AIN457 300mg
204580|NCT01358578|E7|Reported Event|ENTIRE-Any AIN457 150mg|ENTIRE-Any AIN457 150mg
204581|NCT01358578|E6|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
204582|NCT01358578|E5|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
204583|NCT01358578|E4|Reported Event|INDUCTION-Etanercept|INDUCTION-Etanercept
204584|NCT01358578|E3|Reported Event|INDUCTION-Placebo|INDUCTION-Placebo
204585|NCT01358578|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
204586|NCT01358578|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
204587|NCT01358526|B3|Baseline|Total|Total of all reporting groups
204588|NCT01358526|B2|Baseline|Placebo Group|"Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours"
204589|NCT01358526|B1|Baseline|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
204590|NCT01358526|P3|Participant Flow|Placebo Group|"Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours"
204591|NCT01358526|P2|Participant Flow|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
204592|NCT01358526|P1|Participant Flow|Open-label Titration OXN|The open-label titration was designed to identify a stable, effective, and tolerable dose of OXN for each subject.
204593|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours"
204594|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
204641|NCT01358357|E2|Reported Event|Placebo|Placebo: 20-80 mg flexible dose
204596|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
204597|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours"
204598|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
204599|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours"
204600|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
204601|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours"
204602|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
204603|NCT01358526|E3|Reported Event|Double-blind OXN|"Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
204604|NCT01358526|E2|Reported Event|Double-blind Placebo|"Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours"
204605|NCT01358526|E1|Reported Event|Open-label Titration OXN|"Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
204606|NCT01358357|B3|Baseline|Total|Total of all reporting groups
204607|NCT01358357|B2|Baseline|Placebo|Placebo: 20-80 mg flexible dose
204608|NCT01358357|B1|Baseline|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204609|NCT01358357|P3|Participant Flow|All Subjects|During the Open-label stabilization phase, subjects received flexible does of lurasidone 20 - 80 mg daily.
204610|NCT01358357|P2|Participant Flow|Placebo|Placebo: 20-80 mg flexible dose
204611|NCT01358357|P1|Participant Flow|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204612|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204613|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204614|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204615|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204616|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204617|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204618|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204619|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204620|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204621|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204622|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204623|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204624|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204625|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204626|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204627|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204628|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204629|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204630|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204631|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204632|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204633|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204634|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204635|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204636|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204637|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204638|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
204639|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
205756|NCT01353976|E2|Reported Event|Vehicle Foam|Placebo medication
204642|NCT01358357|E1|Reported Event|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
204643|NCT01358175|B4|Baseline|Total|Total of all reporting groups
204644|NCT01358175|B3|Baseline|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
204645|NCT01358175|B2|Baseline|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204646|NCT01358175|B1|Baseline|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204647|NCT01358175|P3|Participant Flow|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
204648|NCT01358175|P2|Participant Flow|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204649|NCT01358175|P1|Participant Flow|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204650|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
204651|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204652|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204653|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
204654|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204655|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204656|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
204657|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204658|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204659|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
204660|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204661|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204662|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
204663|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204664|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204665|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
204666|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204667|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204668|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
204669|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204670|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204671|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
204672|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204673|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204674|NCT01358175|E7|Reported Event|Placebo Resp Secukinumab 150 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 150 mg
204675|NCT01358175|E6|Reported Event|Placebo Resp Secukinumab 75 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 75 mg
204676|NCT01358175|E5|Reported Event|Placebo Non-Resp Secukinumab 150 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 150 mg
204677|NCT01358175|E4|Reported Event|Placebo Non-Resp Secukinumab 75 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 75 mg
204678|NCT01358175|E3|Reported Event|Placebo Secukinumab|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 up to end of Study
204679|NCT01358175|E2|Reported Event|Secukinumab 10mg/kg -150 mg|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204680|NCT01358175|E1|Reported Event|Secukinumab 10mg/kg -75 mg|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
204681|NCT01357980|B5|Baseline|Total|Total of all reporting groups
204687|NCT01357980|P3|Participant Flow|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204688|NCT01357980|P2|Participant Flow|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204689|NCT01357980|P1|Participant Flow|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204690|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204691|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204692|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204693|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204694|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204695|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204696|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204697|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204698|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204699|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204700|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204701|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204702|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204703|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204704|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204705|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204706|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204707|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204708|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204709|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204710|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204711|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204712|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204713|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204714|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204715|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204716|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204717|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204718|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204719|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204720|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204721|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204722|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204723|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204724|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204725|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
204726|NCT01357980|E4|Reported Event|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204727|NCT01357980|E3|Reported Event|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
204728|NCT01357980|E2|Reported Event|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
204729|NCT01357980|E1|Reported Event|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
204730|NCT01357889|B3|Baseline|Total|Total of all reporting groups
204766|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204790|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204791|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204731|NCT01357889|B2|Baseline|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204732|NCT01357889|B1|Baseline|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204733|NCT01357889|P2|Participant Flow|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204734|NCT01357889|P1|Participant Flow|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204735|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204736|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204737|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204738|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204739|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204740|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204741|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204784|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204785|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204742|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204743|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204744|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204745|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204746|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204747|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204748|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204749|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204786|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204787|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204788|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204750|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204751|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204752|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204753|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204754|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204755|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204756|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204757|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204758|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204759|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204760|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204761|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204762|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204763|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204764|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204765|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204789|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204767|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204768|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204769|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204770|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204771|NCT01357889|E2|Reported Event|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204772|NCT01357889|E1|Reported Event|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
204773|NCT01357850|B5|Baseline|Total|Total of all reporting groups
204774|NCT01357850|B4|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204775|NCT01357850|B3|Baseline|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204776|NCT01357850|B2|Baseline|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204777|NCT01357850|B1|Baseline|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204778|NCT01357850|P4|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204779|NCT01357850|P3|Participant Flow|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204780|NCT01357850|P2|Participant Flow|Albiglutide 3.75 mg|Participants received albiglutide 3.75 milligrams (mg) weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204781|NCT01357850|P1|Participant Flow|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204782|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204783|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204864|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
204792|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204793|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204794|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204795|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204796|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204797|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204798|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204799|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204800|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204801|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204802|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204803|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204804|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204805|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204806|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204807|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204808|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204809|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204810|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204811|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204812|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204813|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204814|NCT01357850|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204815|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204816|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204817|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204818|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204819|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204820|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204821|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204822|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204823|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204824|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204825|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204826|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204970|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
204827|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204828|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204829|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204830|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204831|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204832|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204833|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204834|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204835|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204836|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204837|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204838|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204839|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204840|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204841|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204842|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204843|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204844|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204845|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204846|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204847|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204848|NCT01357850|E4|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204849|NCT01357850|E3|Reported Event|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204850|NCT01357850|E2|Reported Event|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204851|NCT01357850|E1|Reported Event|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
204852|NCT01357720|B3|Baseline|Total|Total of all reporting groups
204853|NCT01357720|B2|Baseline|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
204854|NCT01357720|B1|Baseline|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
204855|NCT01357720|P2|Participant Flow|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
204856|NCT01357720|P1|Participant Flow|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
204857|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
204858|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
204859|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
204860|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
204861|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
204862|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
204863|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
204971|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
204865|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
204866|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
204867|NCT01357720|E2|Reported Event|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
204868|NCT01357720|E1|Reported Event|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
204869|NCT01357655|B3|Baseline|Total|Total of all reporting groups
204870|NCT01357655|B2|Baseline|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
204871|NCT01357655|B1|Baseline|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
204872|NCT01357655|P2|Participant Flow|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
204873|NCT01357655|P1|Participant Flow|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
204874|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
204875|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
204876|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
204877|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
204878|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
204879|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
204880|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
204881|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
204882|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
204883|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
204884|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).
Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
204885|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
204886|NCT01357655|E1|Reported Event|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, Once daily, approximately 1 year
204887|NCT01357616|B3|Baseline|Total|Total of all reporting groups
204888|NCT01357616|B2|Baseline|AZOPT + TIMOLOL|Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.
204889|NCT01357616|B1|Baseline|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
204890|NCT01357616|P2|Participant Flow|AZOPT + TIMOLOL|Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.
204891|NCT01357616|P1|Participant Flow|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
204892|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
204893|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
204894|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
204895|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
204896|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
204897|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
204898|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
204899|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
204900|NCT01357616|E2|Reported Event|AZOPT + TIMOLOL (Control Group)|"Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.
Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution"
204901|NCT01357616|E1|Reported Event|AZARGA (Test Group)|"Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks.
Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension"
204902|NCT01357551|B3|Baseline|Total|Total of all reporting groups
204903|NCT01357551|B2|Baseline|Usual Care|Participants are randomized to receive usual care for 56 weeks
204904|NCT01357551|B1|Baseline|Maintenance Intervention|"Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.
Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time."
204905|NCT01357551|P2|Participant Flow|Usual Care|Participants receive usual care for 56 weeks
204906|NCT01357551|P1|Participant Flow|Maintenance Intervention|"Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.
Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time."
204907|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
204908|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.
Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time."
204909|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
204910|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.
Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
204911|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
204912|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.
Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
204913|NCT01357551|O2|Outcome|Usual Care|Participants are randomized to receive usual care for 56 weeks
204914|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.
Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time."
204915|NCT01357551|E2|Reported Event|Usual Care|Participants receive usual care for 56 weeks
204916|NCT01357551|E1|Reported Event|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.
Maintenance intervention: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
204917|NCT01357512|B3|Baseline|Total|Total of all reporting groups
204918|NCT01357512|B2|Baseline|no MRI|No MRI before prostate biopsies
204919|NCT01357512|B1|Baseline|MRI Done|"Subjects with MRI prior prostate biopsies
magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
204920|NCT01357512|P2|Participant Flow|no MRI|No MRI before prostate biopsies
204921|NCT01357512|P1|Participant Flow|MRI Done|"Subjects with MRI prior prostate biopsies
magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
204922|NCT01357512|O2|Outcome|no MRI|No MRI before prostate biopsies
204923|NCT01357512|O1|Outcome|MRI Done|"Subjects with MRI prior prostate biopsies
magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
204924|NCT01357512|O2|Outcome|no MRI|No MRI before prostate biopsies
204925|NCT01357512|O1|Outcome|MRI Done|"Subjects with MRI prior prostate biopsies
magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
204926|NCT01357512|E2|Reported Event|no MRI|No MRI before prostate biopsies
204927|NCT01357512|E1|Reported Event|MRI Done|"Subjects with MRI prior prostate biopsies
magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
204928|NCT01357239|B5|Baseline|Total|Total of all reporting groups
204929|NCT01357239|B4|Baseline|Placebo|2 capsules of placebo per intake
204930|NCT01357239|B3|Baseline|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
204931|NCT01357239|B2|Baseline|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
204932|NCT01357239|B1|Baseline|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
204933|NCT01357239|P4|Participant Flow|Placebo|2 capsules of placebo per intake
204934|NCT01357239|P3|Participant Flow|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
204935|NCT01357239|P2|Participant Flow|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
204936|NCT01357239|P1|Participant Flow|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
204937|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
204938|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
204939|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
204940|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
204941|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
204942|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
204943|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
204944|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
204945|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
204946|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
204947|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
204948|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
204949|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
204950|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
204951|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
204952|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
204953|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
204954|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
204955|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
204956|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
204957|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
204958|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
204959|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
204960|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
204961|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
204962|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
204963|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
204964|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
204965|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
204966|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
204967|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
204968|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
204969|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
204988|NCT01357239|E2|Reported Event|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
204989|NCT01357239|E1|Reported Event|Placebo|2 capsules of placebo per intake
204990|NCT01357148|B1|Baseline|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
204991|NCT01357148|P1|Participant Flow|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
204992|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|
204993|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|
204994|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
204995|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
204996|NCT01357148|E1|Reported Event|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
204997|NCT01357135|B4|Baseline|Total|Total of all reporting groups
204998|NCT01357135|B3|Baseline|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
204999|NCT01357135|B2|Baseline|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
205000|NCT01357135|B1|Baseline|Metformin + Sitagliptin|Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
205001|NCT01357135|P3|Participant Flow|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
205002|NCT01357135|P2|Participant Flow|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
205003|NCT01357135|P1|Participant Flow|Metformin + Sitagliptin|Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
205004|NCT01357135|O2|Outcome|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
205005|NCT01357135|O1|Outcome|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
205006|NCT01357135|O2|Outcome|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
205007|NCT01357135|O1|Outcome|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
205008|NCT01357135|E3|Reported Event|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
205009|NCT01357135|E2|Reported Event|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
205010|NCT01357135|E1|Reported Event|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
205011|NCT01356966|B3|Baseline|Total|Total of all reporting groups
205012|NCT01356966|B2|Baseline|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
205013|NCT01356966|B1|Baseline|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
205014|NCT01356966|P2|Participant Flow|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
205015|NCT01356966|P1|Participant Flow|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
205016|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
205017|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
205018|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
205019|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
205020|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
205021|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
205022|NCT01356966|E2|Reported Event|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
205023|NCT01356966|E1|Reported Event|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
205024|NCT01356940|B3|Baseline|Total|Total of all reporting groups
205059|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205025|NCT01356940|B2|Baseline|Placebo Followed by Dalfampridine ER 10mg Bid|"• Age 18-75 inclusive, Male or Female identical placebo tablet administered bid for four weeks
Group B: identical placebo tablet administered bid for four weeks, 2 week washout, then dalfampridine ER 10mg bid for 4 weeks"
205026|NCT01356940|B1|Baseline|Dalfampridine ER 10mg Bid Followed by Placebo|"• Age 18-75 inclusive, Male or Female 4 week administration of dalfampridine ER 10mg bid
Group A: dalfampridine ER 10mg bid for 4 weeks, 2 week washout, then matching placebo for 4 weeks"
205027|NCT01356940|P2|Participant Flow|Placebo-dalfampridine ER 10mg Bid|placebo tablet administered bid for four weeks followed by 2 week washout and dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks
205028|NCT01356940|P1|Participant Flow|Dalfampridine ER 10mg Bid- Placebo|4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo
205029|NCT01356940|O2|Outcome|Placebo|"identical placebo tablet administered bid for four weeks
placebo: identical placebo tablet administered bid for four weeks"
205030|NCT01356940|O1|Outcome|Dalfampridine ER 10mg Bid|"4 week administration of dalfampridine ER 10mg bid
dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks"
205031|NCT01356940|E2|Reported Event|Placebo|"identical placebo tablet administered bid for four weeks
placebo: identical placebo tablet administered bid for four weeks"
205032|NCT01356940|E1|Reported Event|Dalfampridine ER 10mg Bid|"4 week administration of dalfampridine ER 10mg bid
dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks"
205033|NCT01356667|B3|Baseline|Total|Total of all reporting groups
205034|NCT01356667|B2|Baseline|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
205035|NCT01356667|B1|Baseline|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
205036|NCT01356667|P2|Participant Flow|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
205037|NCT01356667|P1|Participant Flow|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
205038|NCT01356667|O2|Outcome|DARTNA|"12-week DARTNA program
DARTNA: 3-hour protocol provided 2x/week over 12 weeks"
205039|NCT01356667|O1|Outcome|Treatment-As-Usual|"Substance Abuse treatment typically received
Treatment-As-Usual: Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions."
205040|NCT01356667|O2|Outcome|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
205041|NCT01356667|O1|Outcome|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
205042|NCT01356667|O2|Outcome|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
205043|NCT01356667|O1|Outcome|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
205044|NCT01356667|E2|Reported Event|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
205045|NCT01356667|E1|Reported Event|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
205046|NCT01356602|B4|Baseline|Total|Total of all reporting groups
205047|NCT01356602|B3|Baseline|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205048|NCT01356602|B2|Baseline|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205049|NCT01356602|B1|Baseline|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205050|NCT01356602|P3|Participant Flow|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205051|NCT01356602|P2|Participant Flow|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205052|NCT01356602|P1|Participant Flow|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205053|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205054|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205055|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205056|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205057|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205058|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205060|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205061|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205062|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205063|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205064|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205065|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205066|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205067|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205068|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205069|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205070|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205071|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205072|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205073|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205074|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205075|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205076|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205077|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205078|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205079|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205080|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205081|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205082|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205083|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205084|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205085|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205086|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205087|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205088|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205089|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205090|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205091|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205092|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205093|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205094|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205095|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205096|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205097|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205098|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205099|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205100|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205101|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205102|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205103|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205104|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205105|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205106|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205107|NCT01356602|E3|Reported Event|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
205108|NCT01356602|E2|Reported Event|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
205109|NCT01356602|E1|Reported Event|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
205110|NCT01356589|B1|Baseline|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
205359|NCT01355224|O5|Outcome|High Lifestyle Risk Feedback|Lifestyle feedback arm; had elevated risk for obesity based on lifestyle behavior alone.
205111|NCT01356589|P1|Participant Flow|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
205112|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
205113|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
205114|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
205115|NCT01356589|E1|Reported Event|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
205116|NCT01356498|B7|Baseline|Total|Total of all reporting groups
205117|NCT01356498|B6|Baseline|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205118|NCT01356498|B5|Baseline|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205119|NCT01356498|B4|Baseline|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205120|NCT01356498|B3|Baseline|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
205121|NCT01356498|B2|Baseline|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205122|NCT01356498|B1|Baseline|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
205123|NCT01356498|P6|Participant Flow|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205124|NCT01356498|P5|Participant Flow|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205125|NCT01356498|P4|Participant Flow|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205126|NCT01356498|P3|Participant Flow|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
205127|NCT01356498|P2|Participant Flow|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205128|NCT01356498|P1|Participant Flow|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
205129|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205130|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205131|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205132|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
205133|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205134|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
205135|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205136|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205137|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205757|NCT01353976|E1|Reported Event|Econazole Nitrate Foam 1%|Study medication
205138|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
205139|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205140|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
205141|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in RCT, initiated pegloticase treatment q4 wk in OLE
205142|NCT01356498|O5|Outcome|q4 RCT, Non-responder|Non-responder in Pegloticase every 4 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
205143|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
205144|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in RCT, initiated pegloticase treatment q2 wk in OLE
205145|NCT01356498|O2|Outcome|q4 RCT Responder|REsponder in Pegloticase every 4 wk arm of RCT, contuned to received pegloticase (q2 wk or q4 wk) in OLE
205146|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
205147|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205148|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205149|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205150|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
205151|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205152|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
205153|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205154|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205155|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205156|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
205157|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205158|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
205159|NCT01356498|E6|Reported Event|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205160|NCT01356498|E5|Reported Event|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205161|NCT01356498|E4|Reported Event|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205162|NCT01356498|E3|Reported Event|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
205163|NCT01356498|E2|Reported Event|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
205164|NCT01356498|E1|Reported Event|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
205165|NCT01356407|B3|Baseline|Total|Total of all reporting groups
205166|NCT01356407|B2|Baseline|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
205167|NCT01356407|B1|Baseline|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
205168|NCT01356407|P2|Participant Flow|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
205169|NCT01356407|P1|Participant Flow|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
205170|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
205360|NCT01355224|O4|Outcome|Low Lifestyle Risk Feedback|Lifestyle feedback arm; did not have elevated risk for obesity based on lifestyle behavior alone.
205171|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
205172|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
205173|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
205174|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
205175|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
205176|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
205177|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
205178|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
205179|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
205180|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
205181|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
205182|NCT01356407|E2|Reported Event|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
205183|NCT01356407|E1|Reported Event|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
205184|NCT01356147|B3|Baseline|Total|Total of all reporting groups
205185|NCT01356147|B2|Baseline|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
205186|NCT01356147|B1|Baseline|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.
Placebo: No therapy will be given to placebo arm"
205187|NCT01356147|P2|Participant Flow|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
205188|NCT01356147|P1|Participant Flow|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.
Placebo: No therapy will be given to placebo arm"
205189|NCT01356147|O2|Outcome|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
205190|NCT01356147|O1|Outcome|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.
Placebo: No therapy will be given to placebo arm"
205191|NCT01356147|E2|Reported Event|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
205192|NCT01356147|E1|Reported Event|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.
Placebo: No therapy will be given to placebo arm"
205193|NCT01355978|B1|Baseline|Noninvasive Open Ventilation System|Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System used during activities of daily living.
205194|NCT01355978|P1|Participant Flow|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.
Noninvasive Open Ventilation System: Noninvasive ventilation system"
205195|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.
Noninvasive Open Ventilation System: Noninvasive ventilation system"
205196|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.
Noninvasive Open Ventilation System: Noninvasive ventilation system"
205197|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.
Noninvasive Open Ventilation System: Noninvasive ventilation system"
205198|NCT01355978|E1|Reported Event|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.
Noninvasive Open Ventilation System: Noninvasive ventilation system"
205199|NCT01355705|B1|Baseline|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.
Concurrent therapeutic medications:
Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)
Other drugs:
Aspirin: 81 or 325 mg daily oral
Pegfilgrastim subcutaneous on Day 2"
205200|NCT01355705|P1|Participant Flow|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.
Concurrent therapeutic medications:
Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)
Other drugs:
Aspirin: 81 or 325 mg daily oral
Pegfilgrastim subcutaneous on Day 2"
205201|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.
Concurrent therapeutic medications:
Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)
Other drugs:
Aspirin: 81 or 325 mg daily oral
Pegfilgrastim subcutaneous on Day 2"
205202|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.
Concurrent therapeutic medications:
Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)
Other drugs:
Aspirin: 81 or 325 mg daily oral
Pegfilgrastim subcutaneous on Day 2"
205203|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.
Concurrent therapeutic medications:
Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)
Other drugs:
Aspirin: 81 or 325 mg daily oral
Pegfilgrastim subcutaneous on Day 2
Amrubicin: 40, 60, or 80 mg/m2 intravenous (IV)
Lenalidomide: 15 mg daily by mouth
Dexamethasone: 40 mg weekly by mouth
Aspirin: 81 or 325 mg daily by mouth
Pegfilgrastim: 6 mg subcutaneous on Day 2"
205204|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.
Concurrent therapeutic medications:
Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)
Other drugs:
Aspirin: 81 or 325 mg daily oral
Pegfilgrastim subcutaneous on Day 2"
205205|NCT01355705|E1|Reported Event|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.
Concurrent therapeutic medications:
Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)
Other drugs:
Aspirin: 81 or 325 mg daily oral
Pegfilgrastim subcutaneous on Day 2"
205206|NCT01355679|B1|Baseline|Guided Therapy|All subjects receive guided therapy in therapeutic combination (up to 4 agents) provided it includes medications contained in the study report.
205207|NCT01355679|P1|Participant Flow|Guided Therapy|"A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
Guided Therapy: A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for disease response, progression and safety. All patients will be"
205208|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
205209|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
205210|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
205211|NCT01355679|O1|Outcome|Guided Therapy|All subjects receive guided therapy in therapeutic combination (up to 4 agents) provided it includes medications contained in the study report.
205212|NCT01355679|E1|Reported Event|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
205213|NCT01355627|B3|Baseline|Total|Total of all reporting groups
205214|NCT01355627|B2|Baseline|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
205215|NCT01355627|B1|Baseline|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
205216|NCT01355627|P2|Participant Flow|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
205217|NCT01355627|P1|Participant Flow|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
205218|NCT01355627|O2|Outcome|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
205219|NCT01355627|O1|Outcome|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
205220|NCT01355627|O2|Outcome|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
205221|NCT01355627|O1|Outcome|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
205222|NCT01355627|E2|Reported Event|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
205223|NCT01355627|E1|Reported Event|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
205224|NCT01355588|B5|Baseline|Total|Total of all reporting groups
205225|NCT01355588|B4|Baseline|Treatment D, Treatment A, Treatment B, Treatment C|Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
205226|NCT01355588|B3|Baseline|Treatment C, Treatment B, Treatment A, Treatment D|Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
205227|NCT01355588|B2|Baseline|Treatment B, Treatment D, Treatment C, Treatment A|Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
205228|NCT01355588|B1|Baseline|Treatment A, Treatment C, Treatment D, Treatment B|Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
205229|NCT01355588|P4|Participant Flow|Treatment D, Treatment A, Treatment B, Treatment C|Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
205230|NCT01355588|P3|Participant Flow|Treatment C, Treatment B, Treatment A, Treatment D|Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
205231|NCT01355588|P2|Participant Flow|Treatment B, Treatment D, Treatment C, Treatment A|Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
205232|NCT01355588|P1|Participant Flow|Treatment A, Treatment C, Treatment D, Treatment B|Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
205233|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
205234|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
205235|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
205236|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
205237|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
205238|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
205239|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
205240|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
205241|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
205242|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
205243|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
205244|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
205245|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
205246|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
205247|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
205248|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
205249|NCT01355588|E4|Reported Event|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
205250|NCT01355588|E3|Reported Event|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
205251|NCT01355588|E2|Reported Event|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
205252|NCT01355588|E1|Reported Event|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
205253|NCT01355523|B3|Baseline|Total|Total of all reporting groups
205254|NCT01355523|B2|Baseline|Placebo|6 mg oral placebo daily
205255|NCT01355523|B1|Baseline|Melatonin|6 mg oral melatonin daily
205256|NCT01355523|P2|Participant Flow|Placebo|6 mg oral placebo daily
205257|NCT01355523|P1|Participant Flow|Melatonin|6 mg oral melatonin daily
205258|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205259|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205260|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205261|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205262|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205263|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205264|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205265|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205266|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205267|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205268|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205269|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205270|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205271|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205272|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205273|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205274|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205275|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205276|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205277|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205278|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205279|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205280|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205281|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205282|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205283|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205284|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205285|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205286|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205287|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205288|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205289|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205290|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205291|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205292|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205293|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205294|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
205295|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
205296|NCT01355523|E2|Reported Event|Placebo|6 mg oral placebo daily
205297|NCT01355523|E1|Reported Event|Melatonin|6 mg oral melatonin daily
205298|NCT01355484|B3|Baseline|Total|Total of all reporting groups
205299|NCT01355484|B2|Baseline|Placebo|"subject will receive placebo for the duration of the trial
placebo: subject will receive placebo for the duration of the trial"
205300|NCT01355484|B1|Baseline|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial
GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
205301|NCT01355484|P2|Participant Flow|Placebo|"subject will receive placebo for the duration of the trial
placebo: subject will receive placebo for the duration of the trial"
205302|NCT01355484|P1|Participant Flow|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial
GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
205303|NCT01355484|O2|Outcome|Placebo|"subject will receive placebo for the duration of the trial
placebo: subject will receive placebo for the duration of the trial"
205304|NCT01355484|O1|Outcome|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial
GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
205305|NCT01355484|O2|Outcome|Placebo|"subject will receive placebo for the duration of the trial
placebo: subject will receive placebo for the duration of the trial"
205306|NCT01355484|O1|Outcome|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial
GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
205307|NCT01355484|E2|Reported Event|Placebo|"subject will receive placebo for the duration of the trial
placebo: subject will receive placebo for the duration of the trial"
205308|NCT01355484|E1|Reported Event|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial
GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
205309|NCT01355471|B3|Baseline|Total|Total of all reporting groups
205310|NCT01355471|B2|Baseline|Placebo|
205311|NCT01355471|B1|Baseline|CD07805/47 Gel|
205312|NCT01355471|P2|Participant Flow|Placebo|
205313|NCT01355471|P1|Participant Flow|CD07805/47 Gel|
205314|NCT01355471|O2|Outcome|Placebo|
205315|NCT01355471|O1|Outcome|CD07805/47 Gel|
205316|NCT01355471|E2|Reported Event|Placebo|
205317|NCT01355471|E1|Reported Event|CD07805/47 Gel|
205318|NCT01355458|B3|Baseline|Total|Total of all reporting groups
205319|NCT01355458|B2|Baseline|Placebo|
205320|NCT01355458|B1|Baseline|CD07805/47 Gel|
205321|NCT01355458|P2|Participant Flow|Placebo|
205322|NCT01355458|P1|Participant Flow|CD07805/47 Gel|
205323|NCT01355458|O2|Outcome|Placebo|
205324|NCT01355458|O1|Outcome|CD07805/47 Gel|
205325|NCT01355458|E2|Reported Event|Placebo|
205326|NCT01355458|E1|Reported Event|CD07805/47 Gel|
205327|NCT01355419|B1|Baseline|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
205328|NCT01355419|P1|Participant Flow|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
205329|NCT01355419|O1|Outcome|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
205330|NCT01355419|O1|Outcome|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
205331|NCT01355419|E1|Reported Event|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
205332|NCT01355302|B1|Baseline|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
205333|NCT01355302|P3|Participant Flow|Phase 2: Capecitabine + Cisplatin|Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes.
205334|NCT01355302|P2|Participant Flow|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the maximum tolerated dose (MTD) as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.
The study was terminated prior to Phase 2."
205335|NCT01355302|P1|Participant Flow|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
205336|NCT01355302|O2|Outcome|Phase 2: Capecitabine + Cisplatin|"The dose of golvatinib was to be the MTD as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.
The study was terminated prior to Phase 2."
205337|NCT01355302|O1|Outcome|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the MTD as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.
The study was terminated prior to Phase 2."
205338|NCT01355302|O2|Outcome|Phase 2: Capecitabine + Cisplatin|"The dose of golvatinib was to be the MTD as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.
The study was terminated prior to Phase 2."
205339|NCT01355302|O1|Outcome|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the maximum tolerated dose (MTD) as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.
The study was terminated prior to Phase 2."
205361|NCT01355224|O3|Outcome|High Genetic Risk Feedback|Genetic feedback arm; had elevated risk for obesity based on FTO alone.
205362|NCT01355224|O2|Outcome|Low Genetic Risk Feedback|Genetic feedback arm; did not have elevated risk for obesity based on FTO alone.
205363|NCT01355224|O1|Outcome|No Risk Feedback|Control - no obesity risk feedback provided.
205340|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by IV infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a DLT in the first 3 participants.
205341|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by IV infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a DLT in the first 3 participants.
205342|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by IV infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a DLT in the first 3 participants.
205343|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
205344|NCT01355302|E1|Reported Event|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
205345|NCT01355224|B5|Baseline|Total|Total of all reporting groups
205346|NCT01355224|B4|Baseline|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
205347|NCT01355224|B3|Baseline|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
205348|NCT01355224|B2|Baseline|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
205349|NCT01355224|B1|Baseline|No Risk Feedback|No risk feedback for obesity was provided.
205350|NCT01355224|P4|Participant Flow|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
205351|NCT01355224|P3|Participant Flow|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
205352|NCT01355224|P2|Participant Flow|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
205353|NCT01355224|P1|Participant Flow|No Risk Feedback|No risk feedback for obesity was provided.
205354|NCT01355224|O5|Outcome|High Genetic Risk + High Lifestyle Risk Feedback|Feedback received: Had elevated risk for obesity based on FTO; Had elevated risk for obesity based on lifestyle behavior.
205355|NCT01355224|O4|Outcome|High Genetic Risk + Low Lifestyle Risk Feedback|Feedback received: Had elevated risk for obesity based on FTO; did not have elevated risk for obesity based on lifestyle behavior.
205356|NCT01355224|O3|Outcome|Low Genetic Risk + High Lifestyle Risk Feedback|Feedback received: Did not have elevated risk for obesity based on FTO; had elevated risk for obesity based on lifestyle behavior.
205357|NCT01355224|O2|Outcome|Low Genetic Risk + Low Lifestyle Risk Feedback|Feedback received: Did not have elevated risk for obesity based on FTO; did not have elevated risk for obesity based on lifestyle behavior.
205358|NCT01355224|O1|Outcome|No Risk Feedback|Control - no obesity risk feedback provided.
205364|NCT01355224|O4|Outcome|Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
205365|NCT01355224|O3|Outcome|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
205366|NCT01355224|O2|Outcome|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
205367|NCT01355224|O1|Outcome|No Risk Feedback|Control - no obesity risk feedback provided.
205368|NCT01355224|E4|Reported Event|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results.
Lifestyle: Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors."
205369|NCT01355224|E3|Reported Event|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.
205370|NCT01355224|E2|Reported Event|Genetic Risk Feedback|FTO variant: Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results.
205371|NCT01355224|E1|Reported Event|No Risk Feedback|Control arm - no obesity risk feedback provided
205372|NCT01355081|B4|Baseline|Total|Total of all reporting groups
205373|NCT01355081|B3|Baseline|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
205374|NCT01355081|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
205375|NCT01355081|B1|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
205376|NCT01355081|P3|Participant Flow|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
205377|NCT01355081|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
205378|NCT01355081|P1|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
205379|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
205380|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
205381|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
205382|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
205383|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
205384|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
205385|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
205386|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
205387|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
205388|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
205389|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
205390|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
205391|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
205392|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
205393|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
205394|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
205395|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
205396|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
205397|NCT01355081|E3|Reported Event|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
205398|NCT01355081|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
205399|NCT01355081|E1|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
205400|NCT01355068|B1|Baseline|Entire Study Population|Includes participants randomized to receive Epanutin (phenytoin) infatabs 50 mg first and Dilantin (phenytoin) infatabs 50 mg first.
205401|NCT01355068|P2|Participant Flow|Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in first intervention period; and single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
205402|NCT01355068|P1|Participant Flow|Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 milligram (mg) chewable tablet in first intervention period; and single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
205403|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
205404|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
205405|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
205406|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
205407|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
205408|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
205409|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
205410|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
205411|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
205412|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
205413|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
205414|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
205415|NCT01355068|E2|Reported Event|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
205416|NCT01355068|E1|Reported Event|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
205417|NCT01354990|B1|Baseline|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
205418|NCT01354990|P1|Participant Flow|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
205419|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
205420|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
205421|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
205422|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
205423|NCT01354990|E1|Reported Event|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
205424|NCT01354938|B1|Baseline|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
205425|NCT01354938|P1|Participant Flow|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
205426|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
205427|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
205428|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
205429|NCT01354938|E1|Reported Event|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
205430|NCT01354899|B1|Baseline|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.
Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
205431|NCT01354899|P1|Participant Flow|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.
Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
205480|NCT01354314|P2|Participant Flow|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205481|NCT01354314|P1|Participant Flow|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205432|NCT01354899|O1|Outcome|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.
Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
205433|NCT01354899|O1|Outcome|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.
Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
205434|NCT01354899|E1|Reported Event|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.
Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
205435|NCT01354652|B4|Baseline|Total|Total of all reporting groups
205436|NCT01354652|B3|Baseline|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
205437|NCT01354652|B2|Baseline|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
205438|NCT01354652|B1|Baseline|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
205439|NCT01354652|P3|Participant Flow|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
205440|NCT01354652|P2|Participant Flow|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
205441|NCT01354652|P1|Participant Flow|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
205442|NCT01354652|O3|Outcome|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
205443|NCT01354652|O2|Outcome|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
205444|NCT01354652|O1|Outcome|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
205445|NCT01354652|E3|Reported Event|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
205446|NCT01354652|E2|Reported Event|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
205447|NCT01354652|E1|Reported Event|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
205448|NCT01354431|B4|Baseline|Total|Total of all reporting groups
205449|NCT01354431|B3|Baseline|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205450|NCT01354431|B2|Baseline|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205451|NCT01354431|B1|Baseline|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (q 3 weeks), until Progressive disease (PD), toxicity or discontinued for other reasons
205452|NCT01354431|P3|Participant Flow|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
205453|NCT01354431|P2|Participant Flow|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
205454|NCT01354431|P1|Participant Flow|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
205455|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205456|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205457|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205458|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205459|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205460|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205461|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205462|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205463|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205464|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205465|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205466|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
205467|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
205468|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
205469|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (q 3 weeks), until progressive disease (PD), toxicity or discontinued for other reasons.
205470|NCT01354431|E3|Reported Event|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
205471|NCT01354431|E2|Reported Event|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
205472|NCT01354431|E1|Reported Event|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
205473|NCT01354314|B5|Baseline|Total|Total of all reporting groups
205474|NCT01354314|B4|Baseline|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205475|NCT01354314|B3|Baseline|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205476|NCT01354314|B2|Baseline|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205477|NCT01354314|B1|Baseline|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205478|NCT01354314|P4|Participant Flow|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205479|NCT01354314|P3|Participant Flow|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205482|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205483|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205484|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205485|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205486|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205487|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205488|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205489|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205490|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205491|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205492|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205493|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205494|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205495|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205496|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205497|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205498|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205499|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205500|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205501|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205502|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205503|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205504|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205505|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205506|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205507|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205508|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205509|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205510|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205511|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205674|NCT01354132|B3|Baseline|Total|Total of all reporting groups
205512|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205513|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205514|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205515|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205516|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205517|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205518|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205519|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205520|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205521|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205522|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205523|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205524|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205525|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205526|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205527|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205528|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205529|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205530|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205531|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205532|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205533|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205534|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205535|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205536|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205537|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205538|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205539|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205540|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205541|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205542|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205543|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205544|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205545|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205546|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205547|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205548|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205549|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205550|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205551|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205552|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205553|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205554|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205555|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205556|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205557|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205558|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205559|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205560|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205561|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205562|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205563|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205564|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205565|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205566|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205567|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205568|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205569|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205570|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205571|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205744|NCT01354015|E1|Reported Event|Use of Messaging System|"Use of DRMS
DRMS: USE OF TEXT MESSAGING SYSTEM"
205572|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205573|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205574|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205575|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205576|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205577|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205578|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205579|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205580|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205581|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205582|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205583|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205584|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205585|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205586|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205587|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205588|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205589|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205590|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205591|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205592|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205593|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205594|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205595|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205596|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205597|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205598|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205599|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205600|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205601|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205602|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205603|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205604|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205605|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205606|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205607|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205608|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205609|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205610|NCT01354314|E4|Reported Event|Placebo|"Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
205611|NCT01354314|E3|Reported Event|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
205612|NCT01354314|E2|Reported Event|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
205613|NCT01354314|E1|Reported Event|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
205614|NCT01354223|B3|Baseline|Total|Total of all reporting groups
205615|NCT01354223|B2|Baseline|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
205616|NCT01354223|B1|Baseline|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
205617|NCT01354223|P2|Participant Flow|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
205618|NCT01354223|P1|Participant Flow|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
205619|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
205620|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
205621|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
205622|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
205623|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
205624|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
205625|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
205626|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
205627|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
205628|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
205629|NCT01354223|E2|Reported Event|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
205630|NCT01354223|E1|Reported Event|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
205631|NCT01354197|B3|Baseline|Total|Total of all reporting groups
205632|NCT01354197|B2|Baseline|Non-survive at Day 28|The patients who non-survived at 28 days after surgical ICU admission.
205633|NCT01354197|B1|Baseline|Survive at Day 28|The patients who survived at 28 days after surgical ICU admission.
205634|NCT01354197|P1|Participant Flow|All ICU Admission Patients|All ICU admission to surgical intensive care unit at cohort time
205635|NCT01354197|O1|Outcome|All ICU Admission Patients|All ICU admission to surgical intensive care unit at cohort time
205636|NCT01354197|O1|Outcome|All ICU Admission Patients|All ICU admission to surgical intensive care unit at cohort time
205637|NCT01354197|E2|Reported Event|Non-survive at Day 28|Number of participants who Did Not survive at day 28
205638|NCT01354197|E1|Reported Event|Survive at Day 28|Number of participants who survive at day 28
205639|NCT01354145|B3|Baseline|Total|Total of all reporting groups
205640|NCT01354145|B2|Baseline|Celecoxib|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205641|NCT01354145|B1|Baseline|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205642|NCT01354145|P2|Participant Flow|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205745|NCT01353976|B3|Baseline|Total|Total of all reporting groups
205643|NCT01354145|P1|Participant Flow|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205644|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205645|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205646|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205647|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205648|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205649|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205650|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205651|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205652|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205653|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205654|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205655|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205656|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205657|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205658|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205659|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205660|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205661|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205662|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205663|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205664|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205665|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205666|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205667|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205668|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205669|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205670|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205671|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205672|NCT01354145|E2|Reported Event|Celecoxib|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
205673|NCT01354145|E1|Reported Event|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
205675|NCT01354132|B2|Baseline|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205676|NCT01354132|B1|Baseline|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205677|NCT01354132|P2|Participant Flow|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205678|NCT01354132|P1|Participant Flow|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205679|NCT01354132|O1|Outcome|Placebo Group|Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm
205680|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205681|NCT01354132|O1|Outcome|Placebo Group|Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm
205682|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205683|NCT01354132|O1|Outcome|Placebo Group|Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm
205684|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205685|NCT01354132|O1|Outcome|Placebo Group|"Placebo comparison group for study matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205686|NCT01354132|O1|Outcome|N-acetyl-cysteine|n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
205687|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205688|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205689|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205690|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205691|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205692|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205693|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205694|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205695|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205696|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205697|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205698|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205699|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205700|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205701|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205702|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205703|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205704|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205705|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205706|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205707|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205708|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205709|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205710|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205711|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205712|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205713|NCT01354132|E2|Reported Event|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205714|NCT01354132|E1|Reported Event|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
205715|NCT01354106|B1|Baseline|Infant|Investigational adhesive tape control paper tape
205716|NCT01354106|P1|Participant Flow|Adhesive Medical Tape|"Each study participant received both treatment arms: 3M Kind Removal Silicone Tape (1 x 1.5 sample, applied one time, worn 24 hours) and 3M Micropore Silicone Tape (1 x 1.5 sample, applied one ime, worn 24 hours)."
205717|NCT01354106|O2|Outcome|3M Micropore Medical Tape|"1 x 1.5 sample applied one time, worn for 24 hours."
205718|NCT01354106|O1|Outcome|3M Kind Removal Silicone Tape|"1 x 1.5 sample applied one time, worn for 24 hours."
205719|NCT01354106|E2|Reported Event|Control Paper Tape|
205720|NCT01354106|E1|Reported Event|Investigational Adhesive Tape|
205721|NCT01354028|B1|Baseline|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
205722|NCT01354028|P2|Participant Flow|No Massage Therapy First Day, Massage Therapy Second Day|"Day one of study: No massage therapy. Actigraph in place to measure sleep for 3 hours.
Day two of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours."
205723|NCT01354028|P1|Participant Flow|Massage Therapy First Day, no Massage Therapy Second Day|"Day one of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
Day two of study: No massage therapy. Actigraph in place to measure sleep for 3 hours"
205724|NCT01354028|O2|Outcome|No Massage Therapy|This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
205725|NCT01354028|O1|Outcome|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
205726|NCT01354028|O2|Outcome|Heart Rate Without Massage|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
205727|NCT01354028|O1|Outcome|Heart Rate During Massage|Heart rate during massage therapy
205728|NCT01354028|O2|Outcome|Oxygen Saturation Without Massage|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
205729|NCT01354028|O1|Outcome|Oxygen Saturation During Massage|Oxygen saturation during massage therapy
205730|NCT01354028|O2|Outcome|Sleep Efficiency With no Massage Therapy|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
205731|NCT01354028|O1|Outcome|Sleep Efficiency With Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
205732|NCT01354028|E2|Reported Event|No Massage Therapy|This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
205733|NCT01354028|E1|Reported Event|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
205734|NCT01354015|B3|Baseline|Total|Total of all reporting groups
205735|NCT01354015|B2|Baseline|Usual Care|Usual Care
205736|NCT01354015|B1|Baseline|Use of Messaging System|"Use of DRMS
DRMS: USE OF TEXT MESSAGING SYSTEM"
205737|NCT01354015|P2|Participant Flow|Usual Care|Usual Care
205738|NCT01354015|P1|Participant Flow|Use of Messaging System|"Use of DRMS
DRMS: USE OF TEXT MESSAGING SYSTEM"
205739|NCT01354015|O2|Outcome|Usual Care|Usual Care
205740|NCT01354015|O1|Outcome|Use of Messaging System|"Use of DRMS
DRMS: USE OF TEXT MESSAGING SYSTEM"
205741|NCT01354015|O2|Outcome|Usual Care|Usual Care
205742|NCT01354015|O1|Outcome|Use of Messaging System|"Use of DRMS
DRMS: USE OF TEXT MESSAGING SYSTEM"
205743|NCT01354015|E2|Reported Event|Usual Care|Usual Care
205758|NCT01353963|B1|Baseline|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
205759|NCT01353963|P1|Participant Flow|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
205760|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
205761|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
205762|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
205763|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
205764|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
205765|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
205766|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
205767|NCT01353963|E1|Reported Event|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
205768|NCT01353911|B9|Baseline|Total|Total of all reporting groups
205769|NCT01353911|B8|Baseline|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
205770|NCT01353911|B7|Baseline|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205771|NCT01353911|B6|Baseline|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205772|NCT01353911|B5|Baseline|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
206057|NCT01352845|B2|Baseline|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
205773|NCT01353911|B4|Baseline|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205774|NCT01353911|B3|Baseline|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205775|NCT01353911|B2|Baseline|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205776|NCT01353911|B1|Baseline|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205777|NCT01353911|P8|Participant Flow|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
205778|NCT01353911|P7|Participant Flow|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205779|NCT01353911|P6|Participant Flow|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205780|NCT01353911|P5|Participant Flow|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205781|NCT01353911|P4|Participant Flow|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205782|NCT01353911|P3|Participant Flow|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205783|NCT01353911|P2|Participant Flow|Grazoprevir 100 mg|TN non-cirrhotic (NC) participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205784|NCT01353911|P1|Participant Flow|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205785|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
205786|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205787|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205788|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205789|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205790|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205791|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205792|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205793|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
205794|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205795|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205796|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205797|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205798|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205799|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205800|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205801|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
205802|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205803|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205804|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205805|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205806|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205807|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205808|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205809|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
205810|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205811|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205812|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205813|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205814|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205815|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205816|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205817|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
205818|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205819|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205820|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205821|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205822|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205823|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205824|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
206909|NCT01350128|E1|Reported Event|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
205825|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
205826|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205827|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205828|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205829|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205830|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205831|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205832|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205833|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
205834|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205835|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205836|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205837|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205838|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205839|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205840|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205841|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
205842|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205843|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205844|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205845|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205846|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205847|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205848|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205849|NCT01353911|E8|Reported Event|Non-cirr: Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
205885|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
206910|NCT01350115|B3|Baseline|Total|Total of all reporting groups
205850|NCT01353911|E7|Reported Event|Non-cirr: Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205851|NCT01353911|E6|Reported Event|Non-cirr: Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205852|NCT01353911|E5|Reported Event|Non-cirr: Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205853|NCT01353911|E4|Reported Event|Non-cirr: Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205854|NCT01353911|E3|Reported Event|Non-cirr: Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205855|NCT01353911|E2|Reported Event|Non-cirr: Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205856|NCT01353911|E1|Reported Event|Cirr: OL Grazoprevir 100 mg|TN cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
205857|NCT01353898|B7|Baseline|Total|Total of all reporting groups
205858|NCT01353898|B6|Baseline|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
205859|NCT01353898|B5|Baseline|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205860|NCT01353898|B4|Baseline|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205861|NCT01353898|B3|Baseline|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205862|NCT01353898|B2|Baseline|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205863|NCT01353898|B1|Baseline|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205864|NCT01353898|P6|Participant Flow|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
205865|NCT01353898|P5|Participant Flow|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205866|NCT01353898|P4|Participant Flow|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205867|NCT01353898|P3|Participant Flow|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205868|NCT01353898|P2|Participant Flow|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205869|NCT01353898|P1|Participant Flow|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205870|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
205871|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205872|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205873|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205874|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205875|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205876|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
205877|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205878|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205879|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205880|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205881|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205882|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
205883|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205884|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205886|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205887|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205888|NCT01353898|E6|Reported Event|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
205889|NCT01353898|E5|Reported Event|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205890|NCT01353898|E4|Reported Event|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
205891|NCT01353898|E3|Reported Event|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205892|NCT01353898|E2|Reported Event|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205893|NCT01353898|E1|Reported Event|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
205894|NCT01353859|B1|Baseline|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205895|NCT01353859|P1|Participant Flow|Tocilizumab + Methotrexate (MTX)|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (minimum dose 480 mg, maximum dose 800 mg), intravenously (IV), once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205896|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205897|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205898|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205899|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205900|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205901|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205902|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205903|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205919|NCT01353586|O1|Outcome|nMARQ™ System (SNA Subpopulation)|The nMARQ arm of the SNA subpopulation included 19 subjects treated with the nMARQ™ System.
205920|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
205904|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205905|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205906|NCT01353859|E1|Reported Event|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
205907|NCT01353664|B1|Baseline|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
205908|NCT01353664|P1|Participant Flow|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
205909|NCT01353664|O1|Outcome|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
205910|NCT01353664|E1|Reported Event|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
205911|NCT01353586|B3|Baseline|Total|Total of all reporting groups
205912|NCT01353586|B2|Baseline|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.
These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.
Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
205913|NCT01353586|B1|Baseline|nMARQ™ (Main Study- Single Arm)|This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
205914|NCT01353586|P2|Participant Flow|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.
These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.
Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
205915|NCT01353586|P1|Participant Flow|nMARQ™ (Main Study- Single Arm)|This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
205916|NCT01353586|O2|Outcome|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.
These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.
Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are related for transparency; but cannot be compared statistically against the data from the Main Study group."
205917|NCT01353586|O1|Outcome|nMARQ™ System (SNA Subpopulation)|The nMARQ arm of the SNA subpopulation included 19 subjects treated with the nMARQ™ System.
205918|NCT01353586|O2|Outcome|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.
These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.
Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
205921|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
205922|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
205923|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
205924|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
205925|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
205926|NCT01353586|E2|Reported Event|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.
These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.
Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
205927|NCT01353586|E1|Reported Event|nMARQ™ System (Main Study)|nMARQ™ is the Biosense Webster Pulmonary Vein Isolation System consists of Circular and Crescent Mapping and Ablation Catheters and the Multi-channel Radiofrequency Generator. This system is designed to facilitate electrophysiological mapping and transmit radiofrequency from multiple electrodes simultaneously for treating paroxysmal atrial fibrillation (PAF).
205928|NCT01353508|B5|Baseline|Total|Total of all reporting groups
205929|NCT01353508|B4|Baseline|Valsartan to LCZ696 - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205930|NCT01353508|B3|Baseline|LCZ696 to Valsartan - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205931|NCT01353508|B2|Baseline|Valsartan to LCZ696 - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205932|NCT01353508|B1|Baseline|LCZ696 to Valsartan - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205933|NCT01353508|P4|Participant Flow|Valsartan to LCZ696 - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205934|NCT01353508|P3|Participant Flow|LCZ696 to Valsartan - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205935|NCT01353508|P2|Participant Flow|Valsartan to LCZ696 - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205936|NCT01353508|P1|Participant Flow|LCZ696 to Valsartan - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205937|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205938|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205939|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205940|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205941|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205942|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205943|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
206019|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
205944|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205945|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205946|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205947|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205948|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205949|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205950|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205951|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205952|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205953|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205954|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205955|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205956|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205957|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205958|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205959|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205960|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205961|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205962|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205963|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205964|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205965|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205966|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205967|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
206020|NCT01353274|E1|Reported Event|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
205968|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205969|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205970|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205971|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205972|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205973|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205974|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205975|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205976|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205977|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205978|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205979|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205980|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205981|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205982|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205983|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205984|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205985|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205986|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205987|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205988|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205989|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205990|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205991|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
206021|NCT01353222|B3|Baseline|Total|Total of all reporting groups
206911|NCT01350115|B2|Baseline|Placebo|Participants received matching placebo.
205992|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205993|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205994|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205995|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
205996|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
205997|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
205998|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
205999|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
206000|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
206001|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
206002|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
206003|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
206004|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
206005|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
206006|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
206007|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
206008|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
206009|NCT01353508|E4|Reported Event|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
206010|NCT01353508|E3|Reported Event|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
206011|NCT01353508|E2|Reported Event|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
206012|NCT01353508|E1|Reported Event|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
206013|NCT01353274|B1|Baseline|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
206014|NCT01353274|P1|Participant Flow|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
206015|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
206016|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
206017|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
206018|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
206022|NCT01353222|B2|Baseline|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
206023|NCT01353222|B1|Baseline|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
206024|NCT01353222|P2|Participant Flow|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
206025|NCT01353222|P1|Participant Flow|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
206026|NCT01353222|O2|Outcome|Standard of Care|"Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.
Standard of Care: Standard of care"
206027|NCT01353222|O1|Outcome|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
206028|NCT01353222|E2|Reported Event|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.
206029|NCT01353222|E1|Reported Event|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
206030|NCT01353144|B3|Baseline|Total|Total of all reporting groups
206031|NCT01353144|B2|Baseline|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
aspirin: aspirin, 100 mg, qd x 8 weeks"
206032|NCT01353144|B1|Baseline|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
206033|NCT01353144|P2|Participant Flow|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
aspirin: aspirin, 100 mg, qd x 8 weeks"
206034|NCT01353144|P1|Participant Flow|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
206035|NCT01353144|O2|Outcome|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
206036|NCT01353144|O1|Outcome|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
aspirin: aspirin, 100 mg, qd x 8 weeks"
206037|NCT01353144|O2|Outcome|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
aspirin: aspirin, 100 mg, qd x 8 weeks"
206038|NCT01353144|O1|Outcome|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
206039|NCT01353144|E2|Reported Event|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
aspirin: aspirin, 100 mg, qd x 8 weeks"
206040|NCT01353144|E1|Reported Event|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
206041|NCT01353079|B3|Baseline|Total|Total of all reporting groups
206042|NCT01353079|B2|Baseline|Glycero-COCAs|Placebo: Glycero-COCAS sublingual
206043|NCT01353079|B1|Baseline|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
206044|NCT01353079|P2|Participant Flow|Glycero-COCAs|Placebo-Glycero-COCAs sublingual
206045|NCT01353079|P1|Participant Flow|Short Ragweed Pollen Allergenic Extract|"Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
206046|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
206047|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
206048|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
206049|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
206050|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
206051|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
206052|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
206053|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of ragweed allergenic extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
206054|NCT01353079|E2|Reported Event|Glycero-Cocas|placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual
206055|NCT01353079|E1|Reported Event|Ragweed Allergenic Extract|"allergy immunotherapy: Daily administration of ragweed allergenic extract up to 42U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.
placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual"
206056|NCT01352845|B3|Baseline|Total|Total of all reporting groups
206058|NCT01352845|B1|Baseline|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206059|NCT01352845|P2|Participant Flow|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206060|NCT01352845|P1|Participant Flow|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206061|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206062|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206063|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206064|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206065|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206066|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206067|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206068|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206069|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206070|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206071|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206072|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206073|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206074|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206075|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206076|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206077|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206078|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206079|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206080|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206081|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206082|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206083|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206084|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206085|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206086|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206087|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206088|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206089|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206090|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206091|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206092|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206093|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206094|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206095|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206096|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206097|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206098|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206099|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206100|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206101|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206102|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206103|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206104|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206105|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206106|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206107|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206108|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206109|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206110|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206111|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206112|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206113|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206114|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206115|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206116|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206117|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206118|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206119|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206120|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206121|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206122|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206123|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206124|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206125|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206126|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206127|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206128|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206129|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206130|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206131|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206132|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206133|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206134|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206135|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206136|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206137|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206138|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206139|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206140|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206141|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206142|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206143|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206144|NCT01352845|E2|Reported Event|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
206145|NCT01352845|E1|Reported Event|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
206146|NCT01352793|B3|Baseline|Total|Total of all reporting groups
206147|NCT01352793|B2|Baseline|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206148|NCT01352793|B1|Baseline|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206149|NCT01352793|P2|Participant Flow|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206150|NCT01352793|P1|Participant Flow|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206151|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206152|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206153|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206154|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206155|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206156|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206157|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206158|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206159|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206160|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206161|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206162|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206163|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206164|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206165|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206166|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206167|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206168|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206169|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206170|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206171|NCT01352793|E2|Reported Event|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
206172|NCT01352793|E1|Reported Event|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
206173|NCT01352741|B1|Baseline|All Trial Participants|All participants that received at least one dose of tapentadol prolonged release at baseline, in the open-label titration period.
206174|NCT01352741|P2|Participant Flow|Tapentadol Prolonged Release and Pregabalin|At the end of the Open-label Tapentadol Titration Period participants that qualified were randomized to either tapentadol or tapentadol and pregabalin treatment. In this double-blind period participants started on Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
206175|NCT01352741|P1|Participant Flow|Tapentadol Prolonged Release|All participants entered the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion. Participants that did not qualify for entry into the Comparative Period were able to enter the open-label Continuation Period. During the double-blind comparator phase the dose was increased to 200 mg twice daily and after a week to 250 mg twice daily. Participants that dropped out due to tolerability issues during the comparative period were able to enter the open-label pick-up arm.
206176|NCT01352741|O2|Outcome|Tapentadol and Pregabalin in the Comparative Period|Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
206177|NCT01352741|O1|Outcome|Tapentadol in the Comparative Period|The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
206178|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period.
206179|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206180|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206181|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206182|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206183|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206184|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206185|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206186|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206187|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
206188|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
206189|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
206190|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206191|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206192|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206193|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206194|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
206195|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
206196|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
206197|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206198|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206199|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206200|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206201|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
206202|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
206203|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
206204|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206205|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206206|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206207|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206208|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
206209|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
206210|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
206211|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206212|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206213|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206214|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206215|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206216|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206217|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206218|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206219|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206220|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206221|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206222|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206223|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206224|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206225|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206226|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206227|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206228|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206229|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206230|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206231|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206232|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206233|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206234|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206235|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206236|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206237|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206238|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206239|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
206240|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206241|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206242|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206243|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206244|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
206245|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206246|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206247|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206248|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206249|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
206912|NCT01350115|B1|Baseline|LDE225|Participants received 400 mg once daily.
206250|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206251|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206252|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206253|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206254|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration
206255|NCT01352741|O2|Outcome|Tapentadol Prolonged Release After Tapentadol and Pregabalin|Participants that dropped-out of the Tapentadol Prolonged Release and Pregabalin in the double-blind Comparative Period continued with Tapentadol Prolonged Release at either 300 or 400 mg per day in this Open-Label Pick-up arm.
206256|NCT01352741|O1|Outcome|Tapentadol Prolonged Release After Tapentadol|Participants that drop-out of the double-blind tapentadol prolonged release treatment in the Comparative Period, due to tolerability issues, continued on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day in this Open-Label Pick-up arm.
206257|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Participants that did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day, if they had reached a satisfactory level of pain relief.
206258|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
206259|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
206260|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
206261|NCT01352741|E5|Reported Event|Open-Label Tapentadol Continuation Period|Participants who did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day if they had reached a satisfactory level of pain relief.
206262|NCT01352741|E4|Reported Event|Open-Label Tapentadol Pick-Up Arm|Participants that drop-out of the Comparative Period, due to tolerability issues, were permitted to continue on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day.
206263|NCT01352741|E3|Reported Event|Tapentadol and Pregabalin in the Comparative Period|Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
206264|NCT01352741|E2|Reported Event|Tapentadol in the Comparative Period|The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
206265|NCT01352741|E1|Reported Event|Open-Label Tapentadol Titration Period|"During the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion.
Titration dose steps on a weekly basis:
First 50 mg administered twice daily, then 100 mg administered twice daily and then 150 mg administered twice daily.
The titration period could be shortened to 10 days, with a participant at a predefined dose level for at least 3 days.
The dose of 300 mg Tapentadol per day was maintained until the Randomization Visit."
206266|NCT01352715|B3|Baseline|Total|Total of all reporting groups
206267|NCT01352715|B2|Baseline|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily.
Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206268|NCT01352715|B1|Baseline|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Raltegravir: Raltegravir 400 mg tablet orally twice daily."
206269|NCT01352715|P2|Participant Flow|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily.
Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206270|NCT01352715|P1|Participant Flow|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Raltegravir: Raltegravir 400 mg tablet orally twice daily."
206271|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily.
Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206272|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Raltegravir: Raltegravir 400 mg tablet orally twice daily."
206273|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily.
Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206274|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Raltegravir: Raltegravir 400 mg tablet orally twice daily."
206275|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily.
Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206276|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Raltegravir: Raltegravir 400 mg tablet orally twice daily."
206277|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily.
Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206278|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Raltegravir: Raltegravir 400 mg tablet orally twice daily."
206279|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily.
Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206280|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Raltegravir: Raltegravir 400 mg tablet orally twice daily."
206281|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily.
Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206282|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Raltegravir: Raltegravir 400 mg tablet orally twice daily."
206283|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily.
Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206284|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Raltegravir: Raltegravir 400 mg tablet orally twice daily."
206285|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily.
Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206286|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Raltegravir: Raltegravir 400 mg tablet orally twice daily."
206287|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily.
Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206288|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.
Raltegravir: Raltegravir 400 mg tablet orally twice daily."
206289|NCT01352715|E2|Reported Event|LPV/r + NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.
Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.
Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.
Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.
Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.
Zidovudine: Zidovudine 300 mg tablet orally twice daily. Lamivudine: Lamivudine 150 mg tablet orally twice daily."
206290|NCT01352715|E1|Reported Event|LPV/r + RAL|Participants were administered LPV/r plus RAL orally twice daily. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Raltegravir: Raltegravir 400 mg tablet orally twice daily.
206291|NCT01352585|B1|Baseline|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
206292|NCT01352585|P1|Participant Flow|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
206293|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
206294|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
206295|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
206296|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
206297|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
206298|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
206299|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
206300|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
206301|NCT01352585|E1|Reported Event|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
206302|NCT01352546|B1|Baseline|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.
BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
206336|NCT01352507|E4|Reported Event|Sildenafil (Extension Phase)|Participants who preferred sildenafil over tadalafil received 100 mg sildenafil taken orally, as needed, for an additional 8 weeks.
206303|NCT01352546|P1|Participant Flow|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.
BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
206304|NCT01352546|O1|Outcome|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.
BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
206305|NCT01352546|E1|Reported Event|BOTOX|"Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.
BOTOX: 150 units of Botox, and bupivacaine injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia."
206306|NCT01352507|B3|Baseline|Total|Total of all reporting groups
206307|NCT01352507|B2|Baseline|Sildenafil Then Tadalafil|"100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.
At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED."
206308|NCT01352507|B1|Baseline|Tadalafil Then Sildenafil|"20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.
At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED)."
206309|NCT01352507|P2|Participant Flow|Sildenafil Then Tadalafil|"100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.
At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED."
206310|NCT01352507|P1|Participant Flow|Tadalafil Then Sildenafil|"20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.
At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED)."
206311|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206312|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206313|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206314|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206315|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206316|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206317|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206318|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206319|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206320|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206321|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206322|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206323|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206324|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206325|NCT01352507|O2|Outcome|Sildenafil|Participants who preferred sildenafil over tadalafil.
206326|NCT01352507|O1|Outcome|Tadalafil|Participants who preferred tadalafil over sildenafil.
206327|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206328|NCT01352507|O1|Outcome|Tadalafil|20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206329|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206330|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206331|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206332|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206333|NCT01352507|O2|Outcome|Sildenafil|Participants who preferred sildenafil over tadalafil.
206334|NCT01352507|O1|Outcome|Tadalafil|Participants who preferred tadalafil over sildenafil.
206335|NCT01352507|O1|Outcome|All Randomized Participants|Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
206913|NCT01350115|P2|Participant Flow|Placebo|Participants received matching placebo.
206337|NCT01352507|E3|Reported Event|Tadalafil (Extension Phase)|Participants who preferred tadalafil over sildenafil received 20 mg tadalafil taken orally, as needed, for an additional 8 weeks.
206338|NCT01352507|E2|Reported Event|Sildenafil (Treatment Periods)|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206339|NCT01352507|E1|Reported Event|Tadalafil (Treatment Periods)|20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
206340|NCT01352468|B3|Baseline|Total|Total of all reporting groups
206341|NCT01352468|B2|Baseline|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Multifaceted cognitive training: Four computerized training tasks"
206342|NCT01352468|B1|Baseline|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Multifaceted cognitive training: Four computerized training tasks"
206343|NCT01352468|P2|Participant Flow|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Multifaceted cognitive training: Four computerized training tasks"
206344|NCT01352468|P1|Participant Flow|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Multifaceted cognitive training: Four computerized training tasks"
206345|NCT01352468|O2|Outcome|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Multifaceted cognitive training: Four computerized training tasks"
206346|NCT01352468|O1|Outcome|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Multifaceted cognitive training: Four computerized training tasks"
206347|NCT01352468|O2|Outcome|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Multifaceted cognitive training: Four computerized training tasks"
206348|NCT01352468|O1|Outcome|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Multifaceted cognitive training: Four computerized training tasks"
206349|NCT01352468|O2|Outcome|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Multifaceted cognitive training: Four computerized training tasks"
206350|NCT01352468|O1|Outcome|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Multifaceted cognitive training: Four computerized training tasks"
206351|NCT01352468|E2|Reported Event|Sham Cognitive Training|"Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
Multifaceted cognitive training: Four computerized training tasks"
206352|NCT01352468|E1|Reported Event|Multifaceted Cognitive Training|"Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
Multifaceted cognitive training: Four computerized training tasks"
206353|NCT01352442|B1|Baseline|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
206354|NCT01352442|P1|Participant Flow|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
206355|NCT01352442|O1|Outcome|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
206356|NCT01352442|O1|Outcome|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
206357|NCT01352442|E1|Reported Event|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
206358|NCT01352416|B5|Baseline|Total|Total of all reporting groups
206359|NCT01352416|B4|Baseline|Placebo Pill and Patients Having Non Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
206360|NCT01352416|B3|Baseline|Ranolazine and Patients Having Non Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
206361|NCT01352416|B2|Baseline|Placebo Pill and Patients Having Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
206362|NCT01352416|B1|Baseline|Ranolazine and Patients Having Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
206363|NCT01352416|P4|Participant Flow|Sugar Pills and Patients Having Non CABG Heart Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.
Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses"
206914|NCT01350115|P1|Participant Flow|LDE225|Participants received 400 mg once daily.
206364|NCT01352416|P3|Participant Flow|Ranolazine With Patients Having Non CABG Heart Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
206365|NCT01352416|P2|Participant Flow|Sugar Pill and Patients Having CABG Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.
Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses"
206366|NCT01352416|P1|Participant Flow|Ranolazine and Patients Having CABG Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
206367|NCT01352416|O4|Outcome|Placebo Without CABG|Placebo 2 pills twice daily without CABG
206368|NCT01352416|O3|Outcome|Ranolazine Without CABG|Ranolazine 500 mg 2 pills twice daily without CABG
206369|NCT01352416|O2|Outcome|Placebo With CABG|Placebo 2 pills twice daily with CABG
206370|NCT01352416|O1|Outcome|Ranolazine With Coronary Artery Bypass Graft (CABG)|Ranolazine 500 mg 2 pills twice a day with Coronary Artery Bypass Graft (CABG)
206371|NCT01352416|E4|Reported Event|Placebo Pill and Patients Having Non Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
206372|NCT01352416|E3|Reported Event|Ranolazine and Patients Having Non Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
206373|NCT01352416|E2|Reported Event|Placebo Pill and Patients Having Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
206374|NCT01352416|E1|Reported Event|Ranolazine and Patients Having Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
206375|NCT01352117|B3|Baseline|Total|Total of all reporting groups
206376|NCT01352117|B2|Baseline|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206377|NCT01352117|B1|Baseline|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206378|NCT01352117|P2|Participant Flow|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206379|NCT01352117|P1|Participant Flow|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206380|NCT01352117|O1|Outcome|Arm A: ART With Delayed ET Period (Step 2)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis was limited to the ART with delayed ET period (Step 2).
206381|NCT01352117|O1|Outcome|Arm A: ART With Delayed ET Period (Step 2)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis was limited to the ART with delayed ET period (Step 2).
206382|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206383|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206384|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206385|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206386|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206387|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206388|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206389|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206390|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206424|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206391|NCT01352117|O1|Outcome|Arm A: ART With Delayed ET (Step 2)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis is limited to Arm A participants who entered Step 2 to initiate delayed ET.
206392|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206393|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206394|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206395|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206396|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206397|NCT01352117|O1|Outcome|Arm A: ART Alone Period (Step 1)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
206398|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206399|NCT01352117|O1|Outcome|Arm A: ART Alone Period (Step 1)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
206400|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206401|NCT01352117|O1|Outcome|Arm A: ART Alone Period (Step 1)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
206402|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206403|NCT01352117|O1|Outcome|Arm A: ART Alone Period (Step 1)|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
206404|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206405|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206406|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206407|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206408|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206409|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206410|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206411|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206412|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206413|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206414|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206415|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206416|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206417|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206418|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206419|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206420|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206421|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206422|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206423|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206425|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206426|NCT01352117|O2|Outcome|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206427|NCT01352117|O1|Outcome|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206428|NCT01352117|E2|Reported Event|Arm B: ART With Immediate ET|Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
206429|NCT01352117|E1|Reported Event|Arm A: ART Alone or With Delayed ET|Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
206430|NCT01351623|B1|Baseline|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.
Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
206431|NCT01351623|P1|Participant Flow|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.
Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
206432|NCT01351623|O1|Outcome|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.
Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
206433|NCT01351623|E1|Reported Event|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.
Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
206434|NCT01351506|B3|Baseline|Total|Total of all reporting groups
206435|NCT01351506|B2|Baseline|ICU Non Survivors|Patients who non survivors from ICU discharge status
206436|NCT01351506|B1|Baseline|ICU Survivors|Patients who survivors from ICU discharge status
206437|NCT01351506|P1|Participant Flow|Cohort Patient|A total of 602 patients as inclusion criteria between May 2011 and August 2012 were enrolled on the ICU admission (day 0). One hundred thirty seven patients were excluded due to a short stay in ICU or were not weighed a second time on day 1. The remainder of 465 patients were included and followed in this study.
206438|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
206439|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
206440|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
206441|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
206442|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
206443|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
206444|NCT01351506|E2|Reported Event|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
206445|NCT01351506|E1|Reported Event|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
206446|NCT01351480|B1|Baseline|Abatacept|"open label use of abatacept for 12 months
abatacept: Abatacept administered SC weekly at 125 mg dose"
206447|NCT01351480|P1|Participant Flow|Abatacept|"open label use of abatacept for 12 months
abatacept: Abatacept administered SC weekly at 125 mg dose"
206448|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months
abatacept: Abatacept administered SC weekly at 125 mg dose"
206449|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months
abatacept: Abatacept administered SC weekly at 125 mg dose"
206450|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months
abatacept: Abatacept administered SC weekly at 125 mg dose"
206451|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months
abatacept: Abatacept administered SC weekly at 125 mg dose"
206452|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months
abatacept: Abatacept administered SC weekly at 125 mg dose"
206453|NCT01351480|E1|Reported Event|Abatacept|"open label use of abatacept for 12 months
abatacept: Abatacept administered SC weekly at 125 mg dose"
206454|NCT01351337|B1|Baseline|Intraoperative Functional Monitoring|"intraoperative functional monitoring
diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
206455|NCT01351337|P1|Participant Flow|Intraoperative Functional Monitoring|"intraoperative functional monitoring and diffusion tensor tractography
All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
206456|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring and diffusion tensor tractography
All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
206457|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring
diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
206800|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
206458|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring
diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
206459|NCT01351337|E1|Reported Event|Intraoperative Functional Monitoring|"intraoperative functional monitoring
diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
206460|NCT01351090|B4|Baseline|Total|Total of all reporting groups
206461|NCT01351090|B3|Baseline|Placebo Vehicle IN|Intranasal placebo
206462|NCT01351090|B2|Baseline|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
206463|NCT01351090|B1|Baseline|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
206464|NCT01351090|P3|Participant Flow|Placebo Vehicle IN|Intranasal placebo
206465|NCT01351090|P2|Participant Flow|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
206466|NCT01351090|P1|Participant Flow|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
206467|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
206468|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
206469|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
206470|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
206471|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
206472|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
206473|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
206474|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
206475|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
206476|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
206477|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
206478|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
206479|NCT01351090|E3|Reported Event|Placebo Vehicle IN|Intranasal placebo
206480|NCT01351090|E2|Reported Event|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
206481|NCT01351090|E1|Reported Event|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
206482|NCT01351077|B3|Baseline|Total|Total of all reporting groups
206483|NCT01351077|B2|Baseline|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
206484|NCT01351077|B1|Baseline|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module
CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
206485|NCT01351077|P2|Participant Flow|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
206486|NCT01351077|P1|Participant Flow|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module
CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
206487|NCT01351077|O2|Outcome|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
206488|NCT01351077|O1|Outcome|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module
CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
206489|NCT01351077|O2|Outcome|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
206490|NCT01351077|O1|Outcome|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module
CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
206491|NCT01351077|O2|Outcome|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
206492|NCT01351077|O1|Outcome|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module
CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
206493|NCT01351077|O2|Outcome|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
206494|NCT01351077|O1|Outcome|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module
CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
206495|NCT01351077|O2|Outcome|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
206496|NCT01351077|O1|Outcome|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module
CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
206497|NCT01351077|E2|Reported Event|CHICA DevScreen Control|This arm will get CHICA without the developmental screening module
206498|NCT01351077|E1|Reported Event|CHICA DevScreen Module|"This arm will get the CHICA Developmental Screening Module
CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening"
206499|NCT01351064|B3|Baseline|Total|Total of all reporting groups
206500|NCT01351064|B2|Baseline|CHICA ADHD Control|This arm received CHICA without the ADHD module
206501|NCT01351064|B1|Baseline|CHICA ADHD Module|"This arm received The CHICA ADHD Module
CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
206502|NCT01351064|P2|Participant Flow|CHICA ADHD Control|This arm received CHICA without the ADHD module
206503|NCT01351064|P1|Participant Flow|CHICA ADHD Module|"This arm received The Child Health Improvement through Computer Automation (CHICA) Attention Deficit Hyperactivity Disorder (ADHD) Module
CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
206504|NCT01351064|O2|Outcome|CHICA ADHD Control|This arm received CHICA without the ADHD module
206505|NCT01351064|O1|Outcome|CHICA ADHD Module|"This arm received The CHICA ADHD Module
CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
206506|NCT01351064|O2|Outcome|CHICA ADHD Control|This arm received CHICA without the ADHD module
206801|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
206507|NCT01351064|O1|Outcome|CHICA ADHD Module|"This arm received The CHICA ADHD Module
CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
206508|NCT01351064|E2|Reported Event|CHICA ADHD Control|This arm received CHICA without the ADHD module
206509|NCT01351064|E1|Reported Event|CHICA ADHD Module|"This arm received The CHICA ADHD Module
CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
206510|NCT01351025|B3|Baseline|Total|Total of all reporting groups
206511|NCT01351025|B2|Baseline|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206512|NCT01351025|B1|Baseline|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206513|NCT01351025|P2|Participant Flow|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206514|NCT01351025|P1|Participant Flow|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206515|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206516|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
206517|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
206518|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206519|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206520|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206521|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206522|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206523|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206524|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206525|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206526|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206527|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206528|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206529|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206530|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206531|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206532|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206533|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206534|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206535|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206536|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206537|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
206538|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
206539|NCT01351025|E4|Reported Event|Arm B: Placebo / Atorvastatin After Cross-over (Week 24 - 48)|At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
206540|NCT01351025|E3|Reported Event|Arm A: Atorvastatin / Placebo After Cross-over (Week 24 - 48)|At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
206541|NCT01351025|E2|Reported Event|Arm B: Placebo / Atorvastatin Before Cross-over (Week 0 - 24)|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
206542|NCT01351025|E1|Reported Event|Arm A: Atorvastatin / Placebo Before Cross-over (Week 0 - 24)|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
206543|NCT01350999|B4|Baseline|Total|Total of all reporting groups
206544|NCT01350999|B3|Baseline|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206545|NCT01350999|B2|Baseline|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206546|NCT01350999|B1|Baseline|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206547|NCT01350999|P3|Participant Flow|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206548|NCT01350999|P2|Participant Flow|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206549|NCT01350999|P1|Participant Flow|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206550|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206551|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206552|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206553|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206554|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206555|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206556|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206557|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206558|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206559|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206560|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206561|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206562|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206563|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206564|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206565|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206566|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206567|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206568|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206569|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206570|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206571|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206572|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206573|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206574|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206575|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206576|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206577|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206578|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206579|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206580|NCT01350999|E3|Reported Event|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
206581|NCT01350999|E2|Reported Event|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
206582|NCT01350999|E1|Reported Event|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
206583|NCT01350973|B4|Baseline|Total|Total of all reporting groups
206584|NCT01350973|B3|Baseline|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206585|NCT01350973|B2|Baseline|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206586|NCT01350973|B1|Baseline|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206587|NCT01350973|P3|Participant Flow|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206588|NCT01350973|P2|Participant Flow|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206589|NCT01350973|P1|Participant Flow|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206590|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206591|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206592|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206593|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206594|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206595|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206596|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206597|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206598|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206599|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206600|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206601|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206602|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206603|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206604|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206605|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206606|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206607|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206608|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206609|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206610|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206611|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206612|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206613|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206614|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206615|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206616|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206617|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206618|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206619|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206620|NCT01350973|E3|Reported Event|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
206621|NCT01350973|E2|Reported Event|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
206622|NCT01350973|E1|Reported Event|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
206623|NCT01350947|B1|Baseline|All Patients|"All participants enrolled.
5-Azacitidine: Administered on Days 1-7 of each Cycle.
Subcutaneous administration:
To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.
The 5-azacitidine suspension is administered subcutaneously.
Intravenous Administration:
5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
206624|NCT01350947|P1|Participant Flow|Arm 1 - 5-Azacitidine|"All participants enrolled.
5-Azacitidine: Administered on Days 1-7 of each Cycle.
Subcutaneous administration:
To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.
The 5-azacitidine suspension is administered subcutaneously.
Intravenous Administration:
5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
206625|NCT01350947|O1|Outcome|Arm 1 - 5-Azacitidine|"All participants enrolled.
5-Azacitidine: Administered on Days 1-7 of each Cycle.
Subcutaneous administration:
To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.
The 5-azacitidine suspension is administered subcutaneously.
Intravenous Administration:
5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
206626|NCT01350947|E1|Reported Event|Arm 1 - 5-Azacitidine|"All participants enrolled.
5-Azacitidine: Administered on Days 1-7 of each Cycle.
Subcutaneous administration:
To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.
The 5-azacitidine suspension is administered subcutaneously.
Intravenous Administration:
5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
206627|NCT01350934|B3|Baseline|Total|Total of all reporting groups
206628|NCT01350934|B2|Baseline|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
206629|NCT01350934|B1|Baseline|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
206630|NCT01350934|P2|Participant Flow|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
206631|NCT01350934|P1|Participant Flow|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
206632|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
206633|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
206634|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
206635|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
206636|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
206637|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
206638|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
206639|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
206640|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
206641|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
206642|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
206643|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
206644|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
206645|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
206646|NCT01350934|E2|Reported Event|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
206647|NCT01350934|E1|Reported Event|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
206648|NCT01350804|B5|Baseline|Total|Total of all reporting groups
206649|NCT01350804|B4|Baseline|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206650|NCT01350804|B3|Baseline|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206651|NCT01350804|B2|Baseline|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206652|NCT01350804|B1|Baseline|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206653|NCT01350804|P4|Participant Flow|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206654|NCT01350804|P3|Participant Flow|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206655|NCT01350804|P2|Participant Flow|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206656|NCT01350804|P1|Participant Flow|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206657|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
206658|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
206659|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
206660|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
206661|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
206662|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
206663|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
206802|NCT01350388|E2|Reported Event|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
206664|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206665|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206666|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206667|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206668|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
206669|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
206670|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
206671|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
206672|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
206673|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
206674|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
206675|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206676|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206677|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206678|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206679|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
206680|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
206681|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
206682|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
206683|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
206684|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
206685|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
206686|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206687|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206688|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206689|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206690|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206691|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206692|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206693|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206694|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
206695|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
206696|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
206697|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
206698|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
206699|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
206700|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
206701|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206702|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206703|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206704|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206705|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206706|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206707|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206708|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206709|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
206710|NCT01350804|O10|Outcome|Abatacept Non-respnders - AIN457 75mg|Participants switched from abatacept to AIN457 75 mg starting at week 24.
206711|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
206712|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
206713|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
206714|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150 mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
206715|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75 mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
206716|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206717|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206718|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206719|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206720|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206721|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206722|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206723|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206724|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206725|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206726|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206727|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206728|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206729|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206730|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206731|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206732|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206733|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206803|NCT01350388|E1|Reported Event|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
206734|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206735|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206736|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206737|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206738|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
206739|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
206740|NCT01350804|E4|Reported Event|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
206741|NCT01350804|E3|Reported Event|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
206742|NCT01350804|E2|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg
206743|NCT01350804|E1|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg
206744|NCT01350583|B1|Baseline|Sodium Bicarbonate Therapy|"Dose Escalation
Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
206745|NCT01350583|P1|Participant Flow|Sodium Bicarbonate Therapy|"Dose Escalation
Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
206746|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation
Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
206747|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation
Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
206748|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation
Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
206749|NCT01350583|E1|Reported Event|Sodium Bicarbonate Therapy|"Dose Escalation
Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
206750|NCT01350544|B3|Baseline|Total|Total of all reporting groups
206751|NCT01350544|B2|Baseline|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
206752|NCT01350544|B1|Baseline|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
206753|NCT01350544|P2|Participant Flow|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
206754|NCT01350544|P1|Participant Flow|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
206755|NCT01350544|O2|Outcome|Treatment Advocacy|Treatment Advocacy: Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, all participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary. This description is subject to change after consideration by the community advisory board.
206756|NCT01350544|O1|Outcome|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
206804|NCT01350271|B4|Baseline|Total|Total of all reporting groups
206757|NCT01350544|E2|Reported Event|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
206758|NCT01350544|E1|Reported Event|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
206759|NCT01350479|B3|Baseline|Total|Total of all reporting groups
206760|NCT01350479|B2|Baseline|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
206761|NCT01350479|B1|Baseline|MRSA Colonized|Residents colonized with MRSA by culture at study admission
206762|NCT01350479|P2|Participant Flow|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
206763|NCT01350479|P1|Participant Flow|MRSA Colonized|Residents colonized with MRSA by culture at study admission
206764|NCT01350479|O2|Outcome|Swabs From Interactions With Not MRSA Colonized Residents|Swabs collected from healthcare workers interacting with residents not colonized with MRSA by culture on enrollment
206765|NCT01350479|O1|Outcome|Swabs From Interactions With MRSA Colonized Residents|Swabs collected from healthcare workers interacting with residents colonized with MRSA by culture on enrollment
206766|NCT01350479|E2|Reported Event|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
206767|NCT01350479|E1|Reported Event|MRSA Colonized|Residents colonized with MRSA by culture at study admission
206768|NCT01350414|B1|Baseline|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02, NCT00231114).
206769|NCT01350414|P1|Participant Flow|Alair Group|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02)
Bronchial Thermoplasty with the Alair System: Bronchial Thermoplasty with the Alair System"
206770|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol Number 04-02, NCT00231114).
206771|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
206772|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
206773|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
206774|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
206775|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
206776|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
206777|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
206778|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
206779|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
206780|NCT01350414|E5|Reported Event|Year 5|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 5 is defined as 1461 days to 1826 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 5 annual visit or not."
206781|NCT01350414|E4|Reported Event|Year 4|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 4 is defined as 1096 to 1460 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 4 annual visit or not."
206782|NCT01350414|E3|Reported Event|Year 3|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 3 is defined as 731 to 1095 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 3 annual visit or not."
206783|NCT01350414|E2|Reported Event|Year 2|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 2 is defined as 366 to 730 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 2 annual visit or not."
206784|NCT01350414|E1|Reported Event|Year 1|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
Year 1 is defined as 365 days from the treatment period (6 weeks after the last bronchoscopy). All subjects were considered in the analysis regardless of whether they have completed the Year 1 annual visit or not."
206785|NCT01350388|B3|Baseline|Total|Total of all reporting groups
206786|NCT01350388|B2|Baseline|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
206787|NCT01350388|B1|Baseline|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
206788|NCT01350388|P2|Participant Flow|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
206789|NCT01350388|P1|Participant Flow|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
206790|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
206791|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
206792|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
206793|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
206794|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
206795|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
206796|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
206797|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
206798|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
206799|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
206805|NCT01350271|B3|Baseline|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg
206806|NCT01350271|B2|Baseline|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
206807|NCT01350271|B1|Baseline|Placebo|Hookworm positive participants randomized to placebo
206808|NCT01350271|P3|Participant Flow|Mebendazole Polymorph C 500 mg|74 were allocated and 48 were followed up in the post treatment.
206809|NCT01350271|P2|Participant Flow|Mebendazole Polymorph A and C 500 mg|70 were allocated and 53 were followed up in the post treatment.
206810|NCT01350271|P1|Participant Flow|Placebo|70 were allocated to this arm and 49 were followed up in the post treatment.
206811|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose Mebendazole polymorph C 500 mg
206812|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
206813|NCT01350271|O1|Outcome|Placebo|Hookworm positive participants randomized to placebo
206814|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose Mebendazole polymorph C 500 mg
206815|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
206816|NCT01350271|O1|Outcome|Placebo|Hookworm positive participants randomized to placebo
206817|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm infected individuals randomized to a single dose of Mebendazole polymorph C 500 mg
206818|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm infected individuals randomized to a single dose of Mebendazole polymorph A and C 500 mg
206819|NCT01350271|O1|Outcome|Placebo|Hookworm infected individual randomized to placebo
206820|NCT01350271|E3|Reported Event|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg
206821|NCT01350271|E2|Reported Event|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
206822|NCT01350271|E1|Reported Event|Placebo|Hookworm positive participants randomized to placebo
206823|NCT01350258|B1|Baseline|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.
TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
206824|NCT01350258|P1|Participant Flow|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.
TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
206825|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.
TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
206826|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.
TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
206827|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.
TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
206828|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.
TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
206829|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.
TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
206893|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
206894|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
206895|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
206896|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
206897|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
206830|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.
TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
206831|NCT01350258|E1|Reported Event|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.
TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
206832|NCT01350245|B1|Baseline|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).
Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)
Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)
Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
206833|NCT01350245|P1|Participant Flow|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).
Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)
Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)
Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
206834|NCT01350245|O1|Outcome|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).
Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)
Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)
Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
206835|NCT01350245|O1|Outcome|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).
Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)
Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)
Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
206836|NCT01350245|E1|Reported Event|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.
Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).
Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)
Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)
Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
206837|NCT01350232|B1|Baseline|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular"
206898|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
206899|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
206900|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
206901|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
206838|NCT01350232|P1|Participant Flow|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular"
206839|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular"
206840|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular"
206841|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular"
206842|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular"
206843|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular"
206844|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular"
206902|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
206903|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
206904|NCT01350128|E6|Reported Event|Placebo BID|Placebo BID.
206905|NCT01350128|E5|Reported Event|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
206906|NCT01350128|E4|Reported Event|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
206907|NCT01350128|E3|Reported Event|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
206908|NCT01350128|E2|Reported Event|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
206845|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular"
206846|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular"
206847|NCT01350232|E1|Reported Event|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular"
206848|NCT01350128|B1|Baseline|ITT Population|ITT Population includes all subjects who were randomized, received at least 1 dose of study treatment, and had both baseline and post-baseline efficacy data for that treatment.
206849|NCT01350128|P1|Participant Flow|All Subjects Randomized|
206850|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
206851|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
206852|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
206853|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
206854|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
206855|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
206856|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
206857|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
206858|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
206859|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
206860|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
206861|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
206862|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
206863|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
206864|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
206865|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
206866|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
206867|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
206868|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
206869|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
206870|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
206871|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
206872|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
206873|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
206874|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
206875|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
206876|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
206877|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
206878|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
206879|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
206880|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
206881|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
206882|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
206883|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
206884|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
206885|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
206886|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
206887|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
206888|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
206889|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
206890|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
206891|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
206892|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
206915|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
206916|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
206917|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
206918|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
206919|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
206920|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
206921|NCT01350115|E4|Reported Event|Placebo - Long Term Follow-up|
206922|NCT01350115|E3|Reported Event|LDE225 - Long Term Follow-up|
206923|NCT01350115|E2|Reported Event|Placebo - Core|Participants received matching placebo.
206924|NCT01350115|E1|Reported Event|LDE225 - Core|Participants received 400 mg once daily.
206925|NCT01349972|B3|Baseline|Total|Total of all reporting groups
206926|NCT01349972|B2|Baseline|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV"
206927|NCT01349972|B1|Baseline|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV"
206928|NCT01349972|P2|Participant Flow|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV"
206929|NCT01349972|P1|Participant Flow|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV"
206930|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV"
206931|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV"
206932|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV"
206933|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV"
206934|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV"
206935|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV"
206936|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV"
206937|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV"
206938|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV"
206958|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206959|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206939|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV"
206940|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV"
206941|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV"
206942|NCT01349972|E2|Reported Event|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV"
206943|NCT01349972|E1|Reported Event|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV"
206944|NCT01349959|B1|Baseline|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.
Azacitidine: Given SC
Entinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
206945|NCT01349959|P1|Participant Flow|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.
Azacitidine: Given SC
Entinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
206946|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.
Azacitidine: Given SC
Entinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
206947|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.
Azacitidine: Given SC
Entinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
206948|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.
Azacitidine: Given SC
Entinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
206949|NCT01349959|E1|Reported Event|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.
Azacitidine: Given SC
Entinostat: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
206950|NCT01349933|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt inhibitor MK2206: Given PO"
206951|NCT01349933|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt inhibitor MK2206: Given PO"
206952|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt inhibitor MK2206: Given PO"
206953|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt inhibitor MK2206: Given PO"
206954|NCT01349933|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206: Given PO
206955|NCT01349920|B1|Baseline|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206956|NCT01349920|P1|Participant Flow|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206957|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206960|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206961|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206962|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206963|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206964|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206965|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206966|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206967|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206968|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206969|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206970|NCT01349920|E3|Reported Event|Post-study|From last dose of study drug, up to 24 days after last dose of infliximab
206971|NCT01349920|E2|Reported Event|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
206972|NCT01349920|E1|Reported Event|Pre-study|From 4 weeks prior to first dose, up to first dose of infliximab
206973|NCT01349907|B3|Baseline|Total|Total of all reporting groups
206974|NCT01349907|B2|Baseline|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206975|NCT01349907|B1|Baseline|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206976|NCT01349907|P2|Participant Flow|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206977|NCT01349907|P1|Participant Flow|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg twice daily (BID), then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206978|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206979|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206980|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206981|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206982|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206983|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206984|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206985|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206986|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206987|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206988|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206989|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207015|NCT01349829|P2|Participant Flow|Havrix|
206990|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206991|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206992|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206993|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206994|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206995|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206996|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206997|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206998|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
206999|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207000|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207001|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207002|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207003|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207004|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207005|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207006|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207007|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207008|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207009|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207010|NCT01349907|E2|Reported Event|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207011|NCT01349907|E1|Reported Event|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
207012|NCT01349829|B3|Baseline|Total|Total of all reporting groups
207013|NCT01349829|B2|Baseline|Havrix|
207014|NCT01349829|B1|Baseline|HAVpur|
207033|NCT01349816|B1|Baseline|Overall Study|All patients randomized and treated
207034|NCT01349816|P1|Participant Flow|Overall Study|Overall Study
207035|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
207036|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
207037|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
207038|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
207039|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
207040|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
207041|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
207042|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
207043|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
207044|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
207045|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
207046|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
207047|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
207048|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
207049|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
207050|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
207051|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
207052|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
207053|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
207054|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
207055|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
207056|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
207057|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
207058|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
207059|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
207060|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
207061|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
207062|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
207063|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
207064|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
207065|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
207066|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
207067|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
207068|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
207069|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
207070|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
207071|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
207072|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
207073|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
207074|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
207075|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
207076|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
207077|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
207078|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
207079|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
207080|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
207081|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
207082|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
207083|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
207084|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
207085|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
207086|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
207087|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
207088|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
207089|NCT01349816|E6|Reported Event|FF MDI 9.6 µg|FF MDI 9.6 µg BID
207090|NCT01349816|E5|Reported Event|GP MDI 36 µg|GP MDI 36 µg BID
207091|NCT01349816|E4|Reported Event|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
207092|NCT01349816|E3|Reported Event|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
207093|NCT01349816|E2|Reported Event|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
207094|NCT01349816|E1|Reported Event|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
207095|NCT01349803|B5|Baseline|Total|Total of all reporting groups
207096|NCT01349803|B4|Baseline|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
207097|NCT01349803|B3|Baseline|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
207098|NCT01349803|B2|Baseline|GP MDI (PT001)|GP MDI 36 mcg
207099|NCT01349803|B1|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg
207100|NCT01349803|P4|Participant Flow|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
207101|NCT01349803|P3|Participant Flow|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
207102|NCT01349803|P2|Participant Flow|GP MDI (PT001)|GP MDI 36 mcg
207103|NCT01349803|P1|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg
207104|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
207105|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
207106|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
207107|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
207108|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207109|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
207110|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
207111|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
207112|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207113|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
207114|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
207115|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
207116|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207117|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
207118|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
207119|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
207120|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207121|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
207122|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
207123|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
207124|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207125|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
207126|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
207127|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
207128|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207129|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
207130|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
207131|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
207132|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207133|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
207134|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
207135|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
207136|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207137|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
207138|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
207139|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
207140|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207141|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
207142|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
207143|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
207144|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207145|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
207146|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
207147|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
207148|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207149|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=55 Day 14: N=55
207150|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=57 Day 14: N=57
207151|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=59 Day 14: N=58
207152|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
207153|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
207154|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
207155|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=59 Day 14: N=59
207156|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
207157|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
207158|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
207159|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
207160|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
207161|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
207162|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
207163|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
207164|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
207165|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
207166|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
207167|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
207168|NCT01349803|E4|Reported Event|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
207169|NCT01349803|E3|Reported Event|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
207170|NCT01349803|E2|Reported Event|GP MDI (PT001)|GP MDI 36 mcg
207171|NCT01349803|E1|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg
207172|NCT01349790|B1|Baseline|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207173|NCT01349790|P1|Participant Flow|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207174|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207175|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207176|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207177|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207178|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207179|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207180|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207181|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207182|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207183|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207184|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207185|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207186|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207187|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207188|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207189|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207190|NCT01349790|E1|Reported Event|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
207191|NCT01349595|B3|Baseline|Total|Total of all reporting groups
207192|NCT01349595|B2|Baseline|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
207193|NCT01349595|B1|Baseline|Bortezomib|"Bortezomib is a type of targeted chemotherapy
Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
207194|NCT01349595|P2|Participant Flow|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
207195|NCT01349595|P1|Participant Flow|Bortezomib|"Bortezomib is a type of targeted chemotherapy
Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
207196|NCT01349595|O2|Outcome|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
207197|NCT01349595|O1|Outcome|Bortezomib|Bortezomib is a type of targeted chemotherapy
207198|NCT01349595|E2|Reported Event|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
207199|NCT01349595|E1|Reported Event|Bortezomib|"Bortezomib is a type of targeted chemotherapy
Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
207200|NCT01349491|B3|Baseline|Total|Total of all reporting groups
207201|NCT01349491|B2|Baseline|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.
Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
207202|NCT01349491|B1|Baseline|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.
Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
207203|NCT01349491|P2|Participant Flow|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.
Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
207204|NCT01349491|P1|Participant Flow|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.
Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
207205|NCT01349491|O2|Outcome|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.
Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
207206|NCT01349491|O1|Outcome|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.
Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
207207|NCT01349491|E2|Reported Event|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.
Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
207208|NCT01349491|E1|Reported Event|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.
Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
207209|NCT01349465|B3|Baseline|Total|Total of all reporting groups
207210|NCT01349465|B2|Baseline|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207211|NCT01349465|B1|Baseline|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207212|NCT01349465|P2|Participant Flow|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207213|NCT01349465|P1|Participant Flow|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207214|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207215|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207216|NCT01349465|O2|Outcome|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207217|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207218|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207219|NCT01349465|O1|Outcome|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207220|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207221|NCT01349465|E3|Reported Event|Total|All Enrolled Subjects
207222|NCT01349465|E2|Reported Event|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207223|NCT01349465|E1|Reported Event|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
207224|NCT01349231|B1|Baseline|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.
ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
207225|NCT01349231|P1|Participant Flow|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.
ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
207226|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.
ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
207227|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.
ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
207228|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.
ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
207229|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.
ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
207230|NCT01349231|E1|Reported Event|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.
ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
207231|NCT01349192|B3|Baseline|Total|Total of all reporting groups
207232|NCT01349192|B2|Baseline|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
207233|NCT01349192|B1|Baseline|Treatment|"Oral antibiotics:
Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.
Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.
Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.
Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.
Topical:
Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.
Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.
Environmental disinfection of high use areas"
207234|NCT01349192|P2|Participant Flow|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
207235|NCT01349192|P1|Participant Flow|Treatment|"Oral antibiotics:
Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.
Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.
Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.
Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.
Topical:
Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.
Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.
Environmental disinfection of high use areas"
207236|NCT01349192|O2|Outcome|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
207237|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:
Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.
Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.
Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.
Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.
Topical:
Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
207238|NCT01349192|O2|Outcome|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
207239|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:
Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.
Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.
Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.
Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.
Topical:
Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.
Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.
Environmental disinfection of high use areas"
207240|NCT01349192|O2|Outcome|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
207241|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:
Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.
Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.
Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.
Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.
Topical:
Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
207242|NCT01349192|O2|Outcome|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
207243|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:
Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.
Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.
Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.
Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.
Topical:
Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
207244|NCT01349192|E2|Reported Event|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
207245|NCT01349192|E1|Reported Event|Treatment|"Oral antibiotics:
Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.
Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.
Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.
Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.
Topical:
Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
207246|NCT01349114|B3|Baseline|Total|Total of all reporting groups
207247|NCT01349114|B2|Baseline|Placebo|Sugar pill/placebo
207248|NCT01349114|B1|Baseline|Aliskiren|aliskiren 300 mg daily
207249|NCT01349114|P2|Participant Flow|Sugar Pill/Placebo|Sugar pill/placebo arm
207250|NCT01349114|P1|Participant Flow|Aliskiren|aliskiren 300 mg daily
207251|NCT01349114|O2|Outcome|Placebo|placebo: placebo
207252|NCT01349114|O1|Outcome|Aliskiren|"aliskiren 300 mg daily
aliskiren: aliskiren 300 mg daily"
207253|NCT01349114|O2|Outcome|Placebo|Sugar pill/ placebo
207254|NCT01349114|O1|Outcome|Aliskiren|aliskiren 300 mg daily
207255|NCT01349114|E2|Reported Event|Placebo|Sugar pill/ placebo
207256|NCT01349114|E1|Reported Event|Aliskiren|aliskiren 300 mg daily
207257|NCT01348854|B3|Baseline|Total|Total of all reporting groups
207258|NCT01348854|B2|Baseline|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
207259|NCT01348854|B1|Baseline|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
207260|NCT01348854|P2|Participant Flow|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
207374|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207261|NCT01348854|P1|Participant Flow|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
207262|NCT01348854|O2|Outcome|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
207263|NCT01348854|O1|Outcome|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
207264|NCT01348854|O2|Outcome|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
207265|NCT01348854|O1|Outcome|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
207266|NCT01348854|E2|Reported Event|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
207267|NCT01348854|E1|Reported Event|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
207268|NCT01348789|B1|Baseline|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
207269|NCT01348789|P1|Participant Flow|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device - 3 treatments in 2-4 day intervals
207270|NCT01348789|O1|Outcome|Hair Clearance From All Areas|Treatment with Hair2Go (Mē) device
207271|NCT01348789|O6|Outcome|Dark Skin - Treat#3|Self assessment of tolerability for skin photo-type V-VI after treatment#3
207272|NCT01348789|O5|Outcome|Dark Skin - Treat#2|Self assessment of tolerability for skin photo-type V-VI after treatment#2
207273|NCT01348789|O4|Outcome|Dark Skin - Treat#1|Self assessment of tolerability for skin photo-type V-VI after treatment#1
207274|NCT01348789|O3|Outcome|Light Skin - Treat#3|Self assessment of tolerability for skin photo-type I-IV after treatment#3.
207275|NCT01348789|O2|Outcome|Light Skin - Treat#2|Self assessment of tolerability for skin photo-type I-IV after treatment#2.
207276|NCT01348789|O1|Outcome|Light Skin - Treat#1|Self assessment of tolerability for skin photo-type I-IV after treatment#1.
207277|NCT01348789|O1|Outcome|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
207278|NCT01348789|E1|Reported Event|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
207279|NCT01348776|B1|Baseline|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
207280|NCT01348776|P1|Participant Flow|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
207281|NCT01348776|O1|Outcome|Hair2Go (Mē)|Subjects treated with the Hair2Go (Me) Device
207282|NCT01348776|O4|Outcome|Maintenance Treatment #3|Self assessment of tolerability level of procedure during 3rd maintenance treatment
207283|NCT01348776|O3|Outcome|Treatment #7|Self assessment of tolerability level of procedure during 7th treatment
207284|NCT01348776|O2|Outcome|Treatment #3|Self assessment of tolerability level of procedure during 3rd treatment
207285|NCT01348776|O1|Outcome|Treatment #1|Self assessment of tolerability level of procedure during 1st treatment
207286|NCT01348776|O1|Outcome|Anticipated Skin Effects|Anticipated skin effects included mild to moderate sense of warmth, tingling, or itching, and transient erythema and edema.
207287|NCT01348776|O2|Outcome|No Maintenance Side|Hair clearance after 7 weekly treatments without additional maintenance treatments
207288|NCT01348776|O1|Outcome|Maintenance Side|Hair clearance after 7 weekly treatments+2 additional monthly maintenance treatments
207289|NCT01348776|O2|Outcome|Hair2Go (Mē) no Maintenance Side|Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized NOT to receive maintenance treatments.
207290|NCT01348776|O1|Outcome|Hair2Go (Mē) Maintenance Side (Before Maintenance Tx)|Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized to receive maintenance treatments. This time point is before maintenance treatments were given.
207291|NCT01348776|E1|Reported Event|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
207292|NCT01348607|B4|Baseline|Total|Total of all reporting groups
207293|NCT01348607|B3|Baseline|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
207294|NCT01348607|B2|Baseline|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
207295|NCT01348607|B1|Baseline|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
207296|NCT01348607|P3|Participant Flow|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
207297|NCT01348607|P2|Participant Flow|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
207298|NCT01348607|P1|Participant Flow|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
207299|NCT01348607|O3|Outcome|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
207300|NCT01348607|O2|Outcome|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
207301|NCT01348607|O1|Outcome|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
207302|NCT01348607|O3|Outcome|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
207303|NCT01348607|O2|Outcome|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
207304|NCT01348607|O1|Outcome|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
207305|NCT01348607|E3|Reported Event|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
207306|NCT01348607|E2|Reported Event|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
207307|NCT01348607|E1|Reported Event|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
207308|NCT01348425|B3|Baseline|Total|Total of all reporting groups
207309|NCT01348425|B2|Baseline|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
207310|NCT01348425|B1|Baseline|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
207311|NCT01348425|P2|Participant Flow|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
207312|NCT01348425|P1|Participant Flow|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
207313|NCT01348425|O2|Outcome|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
207314|NCT01348425|O1|Outcome|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
207315|NCT01348425|E1|Reported Event|Stented Patients|The adverse events were combined because all patients were treated with Zilver PTX stents. The safety of Zilver PTX has been previously established and the primary objective of this study was changes in post-deployment stent length; i.e. immediately post-procedure.
207316|NCT01348165|B8|Baseline|Total|Total of all reporting groups
207317|NCT01348165|B7|Baseline|0.6 mg|BI 137882 with 0.6 mg Dose level
207318|NCT01348165|B6|Baseline|0.5 mg|BI 137882 with 0.5 mg Dose level
207319|NCT01348165|B5|Baseline|0.25 mg|BI 137882 with 0.25 mg Dose level
207320|NCT01348165|B4|Baseline|0.1 mg|BI 137882 with 0.1 mg Dose level
207321|NCT01348165|B3|Baseline|0.03 mg|BI 137882 with 0.03 mg Dose level
207322|NCT01348165|B2|Baseline|0.01 mg|BI 137882 with 0.01 mg Dose level
207323|NCT01348165|B1|Baseline|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207324|NCT01348165|P7|Participant Flow|0.6 mg|BI 137882 with 0.6 mg Dose level
207325|NCT01348165|P6|Participant Flow|0.5 mg|BI 137882 with 0.5 mg Dose level
207326|NCT01348165|P5|Participant Flow|0.25 mg|BI 137882 with 0.25 mg Dose level
207327|NCT01348165|P4|Participant Flow|0.1 mg|BI 137882 with 0.1 mg Dose level
207328|NCT01348165|P3|Participant Flow|0.03 mg|BI 137882 with 0.03 mg Dose level
207329|NCT01348165|P2|Participant Flow|0.01 mg|BI 137882 with 0.01 mg Dose level
207330|NCT01348165|P1|Participant Flow|Placebo|A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
207331|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207332|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
207333|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207334|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207335|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207336|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207337|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207338|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207339|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
207340|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207341|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207342|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207343|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207344|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207345|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207346|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207347|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207348|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207349|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207350|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207351|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207352|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207353|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207354|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207355|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207356|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207357|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207358|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207359|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207360|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207361|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207362|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207363|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207364|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207365|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207366|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207367|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207368|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207369|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207370|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207381|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207382|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207383|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
207384|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207385|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207386|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207387|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207388|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207389|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207390|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
207391|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207392|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207393|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207394|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207395|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207396|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207397|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207398|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207399|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207400|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207401|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207402|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207403|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207404|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207405|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207406|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207407|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207408|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207409|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207410|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207411|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207412|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207413|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207414|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207415|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207416|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207417|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207418|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207419|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207420|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207421|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207422|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207423|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207424|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
207425|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207426|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207427|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207428|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207429|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207430|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207431|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
207432|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207433|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207434|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207435|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207436|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207437|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207438|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
207439|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207440|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207441|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207442|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207443|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207444|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
207445|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
207446|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
207447|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
207448|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
207449|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
207450|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
207451|NCT01348165|E7|Reported Event|0.6 mg|BI 137882 with 0.6 mg Dose level
207452|NCT01348165|E6|Reported Event|0.5 mg|BI 137882 with 0.5 mg Dose level
207453|NCT01348165|E5|Reported Event|0.25 mg|BI 137882 with 0.25 mg Dose level
207454|NCT01348165|E4|Reported Event|0.1 mg|BI 137882 with 0.1 mg Dose level
207455|NCT01348165|E3|Reported Event|0.03 mg|BI 137882 with 0.03 mg Dose level
207456|NCT01348165|E2|Reported Event|0.01 mg|BI 137882 with 0.01 mg Dose level
207457|NCT01348165|E1|Reported Event|Placebo|A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
207458|NCT01348139|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
207459|NCT01348139|P6|Participant Flow|Placebo / 1200 μg / 1400 μg / 300 μg / 880 μg / 800 μg|Placebo followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by AZD3199 800 μg SID.
207460|NCT01348139|P5|Participant Flow|1200 μg / 300 μg / Placebo / 800 μg / 1400 μg / 880 μg|AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 300 μg Turbuhaler inhaler followed by Placebo followed by AZD3199 800 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 880 μg SID.
207461|NCT01348139|P4|Participant Flow|300 μg / 800 μg / 1200 μg / 880 μg / Placebo / 1400 μg|AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by Placebo followed by AZD3199 1400 μg SID.
207462|NCT01348139|P3|Participant Flow|800 μg / 880 μg / 300 μg / 1400 μg / 1200 μg / Placebo|AZD3199 800 μg SID followed by AZD3199 880 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by Placebo.
207463|NCT01348139|P2|Participant Flow|880 μg / 1400 μg / 800 μg / Placebo / 300 μg / 1200 μg|AZD3199 880 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 800 μg SID followed by Placebo followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1200 μg Turbuhaler inhaler.
207464|NCT01348139|P1|Participant Flow|1400 μg / Placebo / 880 μg / 1200 μg / 800 μg / 300 μg|AZD3199 1400 μg SID followed by Placebo followed by AZD3199 880 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 300 μg Turbuhaler inhaler.
207465|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
207466|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207467|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207468|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
207469|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
207470|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
207471|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
207472|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207473|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207474|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
207475|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
207476|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
207477|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
207478|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207479|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207480|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
207481|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
207482|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
207483|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
207484|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207485|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207486|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
207487|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
207488|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
207489|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
207490|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207491|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207492|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
207493|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
207494|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
207495|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
207496|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207497|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207498|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
207499|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
207500|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
207501|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
207502|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207503|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207504|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
207505|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
207506|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
207507|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
207508|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207509|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207510|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
207511|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
207512|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
207513|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
207514|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207515|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207516|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
207517|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
207518|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
207519|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
207520|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207521|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207522|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
207524|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
207525|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
207526|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207527|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207528|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
207529|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
207530|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
207531|NCT01348139|E6|Reported Event|Placebo|Placebo
207532|NCT01348139|E5|Reported Event|AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
207533|NCT01348139|E4|Reported Event|AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
207534|NCT01348139|E3|Reported Event|AZD3199 800 μg|AZD3199 800 μg SID
207535|NCT01348139|E2|Reported Event|AZD3199 880 μg|AZD3199 880 μg SID
207536|NCT01348139|E1|Reported Event|AZD3199 1400 μg|AZD3199 1400 μg SID
207537|NCT01348100|B8|Baseline|Total|Total of all reporting groups
207538|NCT01348100|B7|Baseline|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207539|NCT01348100|B6|Baseline|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207540|NCT01348100|B5|Baseline|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207541|NCT01348100|B4|Baseline|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207542|NCT01348100|B3|Baseline|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207543|NCT01348100|B2|Baseline|Iloperidone 125 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
207544|NCT01348100|B1|Baseline|Iloperidone 50 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
207545|NCT01348100|P7|Participant Flow|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207546|NCT01348100|P6|Participant Flow|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207547|NCT01348100|P5|Participant Flow|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207548|NCT01348100|P4|Participant Flow|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207549|NCT01348100|P3|Participant Flow|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207550|NCT01348100|P2|Participant Flow|Iloperidone 125 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
207551|NCT01348100|P1|Participant Flow|Iloperidone 50 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
207552|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207553|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207554|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207555|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207556|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207557|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207558|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207559|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207560|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207561|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207562|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207563|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207564|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207565|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207566|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207567|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207568|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207569|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207570|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207571|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207572|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207573|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207574|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207643|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
208735|NCT01344538|E1|Reported Event|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations): 2.0 g per day (10:1 extract)
207575|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207576|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207577|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207578|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207579|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207580|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207581|NCT01348100|E14|Reported Event|Iloperidone 625 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart.
207582|NCT01348100|E13|Reported Event|Iloperidone 500 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart.
207583|NCT01348100|E12|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart.
207584|NCT01348100|E11|Reported Event|Iloperidone 625 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207585|NCT01348100|E10|Reported Event|Iloperidone 500 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207586|NCT01348100|E9|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207587|NCT01348100|E8|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase B Depot|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time.
207588|NCT01348100|E7|Reported Event|Iloperidone 250 mg Crystalline Formulation - Phase B Depot|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time.
207589|NCT01348100|E6|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase B Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207590|NCT01348100|E5|Reported Event|Iloperidone 250 mg Crystalline Formulation - Phase B Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
207591|NCT01348100|E4|Reported Event|Iloperidone 125 mg Crystalline Formulation - Phase A Depot|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time.
207592|NCT01348100|E3|Reported Event|Iloperidone 50 mg Crystalline Formulation - Phase A Depot|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time.
207593|NCT01348100|E2|Reported Event|Iloperidone 125 mg Crystalline Formulation - Phase A Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
207594|NCT01348100|E1|Reported Event|Iloperidone 50 mg Crystalline Formulation - Phase A Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
207595|NCT01348087|B1|Baseline|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals
207596|NCT01348087|P1|Participant Flow|AFQ056 Total|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals
207597|NCT01348087|O6|Outcome|AFQ056 Total|
207598|NCT01348087|O5|Outcome|AFQ056 100mg Bid|
207599|NCT01348087|O4|Outcome|AFQ056 75mg Bid|
207600|NCT01348087|O3|Outcome|AFQ056 50mg Bid|
207601|NCT01348087|O2|Outcome|AFQ056 25mg Bid|
207602|NCT01348087|O1|Outcome|Prior to Ext First Dose|
207603|NCT01348087|E6|Reported Event|AFQ056 Total|
207604|NCT01348087|E5|Reported Event|AFQ056 100 mg Bid|AFQ056 100 mg bid
207605|NCT01348087|E4|Reported Event|AFQ056 75 mg Bid|AFQ056 75 mg bid
207606|NCT01348087|E3|Reported Event|AFQ056 50 mg Bid|AFQ056 50 mg bid
207607|NCT01348087|E2|Reported Event|AFQ056 25 mg Bid|AFQ056 25 mg bid
207608|NCT01348087|E1|Reported Event|Prior to Ext.First Dose|Prior to Ext.first dose
207609|NCT01347931|B1|Baseline|Overall Study Group|All subjects participating in 2-way crossover design study
207610|NCT01347931|P1|Participant Flow|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.
Breathe NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
207611|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
207612|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
207613|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
207614|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
207615|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
207616|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
207617|NCT01347931|E2|Reported Event|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
207618|NCT01347931|E1|Reported Event|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.
NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
207619|NCT01347879|B3|Baseline|Total|Total of all reporting groups
207620|NCT01347879|B2|Baseline|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207621|NCT01347879|B1|Baseline|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207622|NCT01347879|P2|Participant Flow|Visonac Cream With PDT|"active treatment with light dose of 37 J/cm2
Visonac photodynamic therapy (PDT): cream application prior to illumination with red light"
207623|NCT01347879|P1|Participant Flow|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207624|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207625|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207626|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207627|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207628|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207629|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207630|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207631|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207632|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207633|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207634|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207635|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207636|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207637|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207638|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207639|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207640|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207641|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207642|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
208812|NCT01344447|O2|Outcome|Unenhanced MRA|
207644|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207645|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207646|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207647|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207648|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207649|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207650|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207651|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207652|NCT01347879|E2|Reported Event|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light"
207653|NCT01347879|E1|Reported Event|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light"
207654|NCT01347840|B1|Baseline|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207655|NCT01347840|P1|Participant Flow|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207656|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207657|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207658|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207659|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207660|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207661|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207662|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207663|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207664|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207665|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207666|NCT01347840|E1|Reported Event|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
207667|NCT01347788|B1|Baseline|Cabozantinib|"Final results have been published Clin Cancer Res. 2013 Jun 1;19(11):3088-94. doi: 10.1158/1078-0432.CCR-13-0319. Epub 2013 Apr 3.
A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases.
Lee RJ, Saylor PJ, Michaelson MD, Rothenberg SM, Smas ME, Miyamoto DT, Gurski CA, Xie W, Maheswaran S, Haber DA, Goldin JG, Smith MR.
Author information Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, USA. rjlee@partners.org"
207668|NCT01347788|P3|Participant Flow|Expansion Cohort|Cabozantinib 40 mg daily
207669|NCT01347788|P2|Participant Flow|Dose Level -1|Cabozantinib 20 mg daily
207670|NCT01347788|P1|Participant Flow|Dose Level 0|Cabozantinib 40 mg daily
207671|NCT01347788|O3|Outcome|Expansion Cohort|Dose level 0: cabozantinib 40 mg daily
207672|NCT01347788|O2|Outcome|Cohort 2|Dose level -1: cabozantinib 20 mg daily
207673|NCT01347788|O1|Outcome|Cohort 1|Dose level 0: cabozantinib 40 mg daily
207674|NCT01347788|E3|Reported Event|Cohort 3|Dose level 0: cabozantinib 40 mg daily
207675|NCT01347788|E2|Reported Event|Cohort 2|Dose level -1: cabozantinib 20 mg daily
207676|NCT01347788|E1|Reported Event|Cohort 1|Dose level 0: cabozantinib 40 mg daily
207677|NCT01347710|B1|Baseline|Flurpiridaz F 18|Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
207678|NCT01347710|P1|Participant Flow|Flurpiridaz F 18|Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
207679|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
207680|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
207681|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
207682|NCT01347710|O1|Outcome|Flurpiridaz F18|"Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
207683|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
207684|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
207685|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
207686|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
207687|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
207688|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
207689|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
207690|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
207691|NCT01347710|E1|Reported Event|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
207692|NCT01347632|B1|Baseline|Metronidazole|Open Label Study
207693|NCT01347632|P1|Participant Flow|Metronidazole|Open Label Study
207694|NCT01347632|O1|Outcome|Metronidazole|Open Label Study
207695|NCT01347632|E1|Reported Event|Metronidazole|Open Label Study
207696|NCT01347580|B3|Baseline|Total|Total of all reporting groups
207697|NCT01347580|B2|Baseline|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207698|NCT01347580|B1|Baseline|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207699|NCT01347580|P2|Participant Flow|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207700|NCT01347580|P1|Participant Flow|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207701|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207702|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207703|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207704|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207705|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207706|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207707|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207708|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207709|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207710|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207711|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207712|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207713|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207714|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
208813|NCT01344447|O1|Outcome|Gadobutrol-Enhanced MRA|
207715|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207716|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207717|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207718|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207719|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207720|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207721|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207722|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207723|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207724|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207725|NCT01347580|E2|Reported Event|Ticagrelor Pre-Hosp|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207726|NCT01347580|E1|Reported Event|Ticagrelor In-Hosp|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
207727|NCT01347554|B3|Baseline|Total|Total of all reporting groups
207728|NCT01347554|B2|Baseline|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
207729|NCT01347554|B1|Baseline|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
207730|NCT01347554|P2|Participant Flow|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
207731|NCT01347554|P1|Participant Flow|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
207732|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
207733|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
207734|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
207735|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
207736|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
207737|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
207738|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
207739|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
207740|NCT01347554|E2|Reported Event|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
207741|NCT01347554|E1|Reported Event|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
207742|NCT01347255|B1|Baseline|LEO 90100 Cutaneous Spray, Ointment|"Intra-Individual baseline analysis population, all treated with the following four products:
LEO 90100 cutaneous spray, ointment: once daily application, 4 weeks (6 days a week)
LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks (6 days a week)
LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4 weeks (6 days a week)
Daivobet® ointment: once daily application, 4 weeks (6 days a week)"
207743|NCT01347255|P1|Participant Flow|All Study Participants|"All subjects received all four treatments:
LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
LEO 90100 cutaneous spray, ointment, vehicle w. betamethasone. Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
LEO 90100 cutaneous spray, ointment, vehicle. Served as a negative control for the two cutaneous spray ointments with active ingredients
Daivobet® ointment. Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Four test sites of approximately 5 cm2 were selected on predetermined psoriasis lesions (target plaques), delimited with a disposable circular device and mapped on a drawn figure.
The distance between two test sites was at least 2 cm. The products were applied on the four test sites (according to random assignment to specific test sites selected on the psoriasis plaque) once daily 6 days a week (except Sundays) for 4 weeks."
207744|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
207745|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
207746|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
207747|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
207748|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
208814|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208815|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
207749|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
207750|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
207751|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
207752|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
207753|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
207754|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
207755|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
207756|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
207757|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
207758|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
207759|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
207760|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
207761|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
207762|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
207763|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
207764|NCT01347255|E1|Reported Event|LEO 90100 Cutaneous Spray, Ointment|"Intra-Individual baseline analysis population, all treated with the following four products:
LEO 90100 cutaneous spray, ointment: once daily application, 4weeks
LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks
LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4weeks
Daivobet® ointment: once daily application, 4weeks"
207765|NCT01347112|B3|Baseline|Total|Total of all reporting groups
207766|NCT01347112|B2|Baseline|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks"
207767|NCT01347112|B1|Baseline|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
207768|NCT01347112|P2|Participant Flow|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks"
207769|NCT01347112|P1|Participant Flow|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
207770|NCT01347112|O2|Outcome|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks"
207771|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
207772|NCT01347112|O2|Outcome|Sugar Pil|"Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks"
207773|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
207774|NCT01347112|O2|Outcome|Sugar Pil|"Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks"
207775|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
207776|NCT01347112|E2|Reported Event|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks"
207777|NCT01347112|E1|Reported Event|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
207778|NCT01347086|B11|Baseline|Total|Total of all reporting groups
207779|NCT01347086|B10|Baseline|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207780|NCT01347086|B9|Baseline|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207781|NCT01347086|B8|Baseline|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207782|NCT01347086|B7|Baseline|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207783|NCT01347086|B6|Baseline|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207784|NCT01347086|B5|Baseline|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207785|NCT01347086|B4|Baseline|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207786|NCT01347086|B3|Baseline|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207787|NCT01347086|B2|Baseline|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207788|NCT01347086|B1|Baseline|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207789|NCT01347086|P10|Participant Flow|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207790|NCT01347086|P9|Participant Flow|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207791|NCT01347086|P8|Participant Flow|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207792|NCT01347086|P7|Participant Flow|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207793|NCT01347086|P6|Participant Flow|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207794|NCT01347086|P5|Participant Flow|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207795|NCT01347086|P4|Participant Flow|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207796|NCT01347086|P3|Participant Flow|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207797|NCT01347086|P2|Participant Flow|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207798|NCT01347086|P1|Participant Flow|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207799|NCT01347086|O6|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207800|NCT01347086|O5|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207801|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207802|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207803|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207804|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207805|NCT01347086|O6|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207806|NCT01347086|O5|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207807|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207808|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207809|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207810|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207811|NCT01347086|O3|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207812|NCT01347086|O2|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207813|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207814|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207815|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207816|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207817|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207818|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207819|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207820|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207821|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207822|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207823|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207824|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207825|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207826|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207827|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207828|NCT01347086|O5|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207829|NCT01347086|O4|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207830|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207831|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207832|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207833|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207834|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207835|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207836|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207837|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207838|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207839|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207840|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207841|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207842|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207843|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207844|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207845|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207846|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207847|NCT01347086|O4|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207848|NCT01347086|O3|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207849|NCT01347086|O2|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207850|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207851|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207852|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207853|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207854|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207855|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207856|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207857|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207858|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207859|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207860|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207861|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207862|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207863|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207864|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207865|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207866|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207867|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207868|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207869|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207870|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207871|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207872|NCT01347086|O10|Outcome|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207873|NCT01347086|O9|Outcome|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207874|NCT01347086|O8|Outcome|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207875|NCT01347086|O7|Outcome|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207876|NCT01347086|O6|Outcome|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207877|NCT01347086|O5|Outcome|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207878|NCT01347086|O4|Outcome|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207879|NCT01347086|O3|Outcome|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207880|NCT01347086|O2|Outcome|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207881|NCT01347086|O1|Outcome|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207882|NCT01347086|O10|Outcome|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207883|NCT01347086|O9|Outcome|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207884|NCT01347086|O8|Outcome|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207885|NCT01347086|O7|Outcome|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207886|NCT01347086|O6|Outcome|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207887|NCT01347086|O5|Outcome|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207888|NCT01347086|O4|Outcome|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207889|NCT01347086|O3|Outcome|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207890|NCT01347086|O2|Outcome|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.
Oral with 240 mL of water in fed condition."
207891|NCT01347086|O1|Outcome|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.
Oral with 240 mL of water in fed condition."
207892|NCT01347086|E4|Reported Event|1200 mg Deleobuvir|All (Caucasian, Japanese and Chinese) subjects that received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition.
207893|NCT01347086|E3|Reported Event|800 mg Deleobuvir|All (Japanese and Chinese) subjects that received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition.
207894|NCT01347086|E2|Reported Event|400 mg Deleobuvir|All (Japanese and Chinese) subjects that received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition.
207895|NCT01347086|E1|Reported Event|Placebo|All (Caucasian, Japanese and Chinese) subjects that received matching placebo. Oral with 240 mL of water in fed condition.
207896|NCT01347073|B1|Baseline|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
207897|NCT01347073|P1|Participant Flow|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
207898|NCT01347073|O1|Outcome|HPN-100|Long Term Treatment
207899|NCT01347073|O2|Outcome|Long-term Phase|The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
207900|NCT01347073|O1|Outcome|Pre-enrollment|12-months preceding the study
207901|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment
207902|NCT01347073|O1|Outcome|NaPBA|Switch Over
207903|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment
207904|NCT01347073|O1|Outcome|NaPBA|Switch Over
207905|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment Arm
207906|NCT01347073|O1|Outcome|NaPBA|Switch Over Arm
207907|NCT01347073|E1|Reported Event|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
207908|NCT01347060|B3|Baseline|Total|Total of all reporting groups
207909|NCT01347060|B2|Baseline|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207910|NCT01347060|B1|Baseline|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
207911|NCT01347060|P2|Participant Flow|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207912|NCT01347060|P1|Participant Flow|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
207913|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
208816|NCT01344447|O2|Outcome|Non-contrast MRA|
207914|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
207915|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207916|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
207917|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207918|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
207919|NCT01347060|E2|Reported Event|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207920|NCT01347060|E1|Reported Event|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
207921|NCT01347034|B3|Baseline|Total|Total of all reporting groups
207922|NCT01347034|B2|Baseline|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
207923|NCT01347034|B1|Baseline|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
207924|NCT01347034|P2|Participant Flow|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
207925|NCT01347034|P1|Participant Flow|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
207926|NCT01347034|O2|Outcome|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
207927|NCT01347034|O1|Outcome|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
207928|NCT01347034|O2|Outcome|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
207929|NCT01347034|O1|Outcome|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
207930|NCT01347034|E2|Reported Event|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
207931|NCT01347034|E1|Reported Event|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
207932|NCT01347008|B3|Baseline|Total|Total of all reporting groups
207933|NCT01347008|B2|Baseline|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
207934|NCT01347008|B1|Baseline|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.
Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
207935|NCT01347008|P2|Participant Flow|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
207936|NCT01347008|P1|Participant Flow|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.
Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
207937|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
207938|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.
Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
207939|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
207940|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.
Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
207941|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
207942|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.
Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
207943|NCT01347008|E2|Reported Event|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
207944|NCT01347008|E1|Reported Event|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.
Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
207945|NCT01346852|B3|Baseline|Total|Total of all reporting groups
207987|NCT01346592|P2|Participant Flow|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208817|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
207946|NCT01346852|B2|Baseline|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207947|NCT01346852|B1|Baseline|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207948|NCT01346852|P2|Participant Flow|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207949|NCT01346852|P1|Participant Flow|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207950|NCT01346852|O2|Outcome|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207951|NCT01346852|O1|Outcome|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207952|NCT01346852|O2|Outcome|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207953|NCT01346852|O1|Outcome|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207954|NCT01346852|E2|Reported Event|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207955|NCT01346852|E1|Reported Event|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
207956|NCT01346839|B3|Baseline|Total|Total of all reporting groups
207957|NCT01346839|B2|Baseline|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
207958|NCT01346839|B1|Baseline|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
208135|NCT01346475|P2|Participant Flow|High-dose Valacyclovir First Then Standard-dose Valacyclovir|High-dose valacyclovir (1 gram three times daily) for 5 weeks followed by 1 week wash-out and then standard-dose valacyclovir (500 mg daily) for 5 weeks
207959|NCT01346839|P2|Participant Flow|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
207960|NCT01346839|P1|Participant Flow|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
207961|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
207962|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
207963|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
207964|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
207965|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
207966|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
207988|NCT01346592|P1|Participant Flow|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207989|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208818|NCT01344447|O2|Outcome|Non-contrast MRA|
208819|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
207967|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
207968|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
207969|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
207970|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
207971|NCT01346839|E2|Reported Event|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
207972|NCT01346839|E1|Reported Event|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
207973|NCT01346774|B3|Baseline|Total|Total of all reporting groups
207974|NCT01346774|B2|Baseline|Placebo|Placebo powder: 2 placebo powder capsules twice a day
207975|NCT01346774|B1|Baseline|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
207976|NCT01346774|P2|Participant Flow|Placebo|Placebo powder: 2 placebo powder capsules twice a day
207977|NCT01346774|P1|Participant Flow|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
207978|NCT01346774|O2|Outcome|Placebo|Placebo powder: 2 placebo powder capsules twice a day
207979|NCT01346774|O1|Outcome|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
207980|NCT01346774|E2|Reported Event|Placebo Capsules|Placebo powder: 2 placebo powder capsules twice a day
207981|NCT01346774|E1|Reported Event|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
207982|NCT01346592|B4|Baseline|Total|Total of all reporting groups
207983|NCT01346592|B3|Baseline|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207984|NCT01346592|B2|Baseline|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207985|NCT01346592|B1|Baseline|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207986|NCT01346592|P3|Participant Flow|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207990|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207991|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207992|NCT01346592|O3|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207993|NCT01346592|O2|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207994|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207995|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207996|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207997|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207998|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
207999|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208000|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208001|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208002|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208003|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208004|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
208005|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
208006|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
208007|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
208008|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
208009|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
208010|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
208011|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
208012|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
208013|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
208014|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
208015|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
208016|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
208017|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
208018|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
208237|NCT01345929|O2|Outcome|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
208019|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
208020|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
208021|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
208022|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
208023|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
208024|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
208025|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
208026|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
208027|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
208028|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
208029|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
208030|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
208031|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
208032|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
208033|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
208034|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
208035|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
208036|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
208037|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
208038|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
208039|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
208040|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208041|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208042|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208043|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208044|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208045|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208046|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208047|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208110|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
208048|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208049|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208050|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208051|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208052|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208053|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208054|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208055|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208056|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208057|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208058|NCT01346592|O3|Outcome|TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
208059|NCT01346592|O2|Outcome|Comparator TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
208060|NCT01346592|O1|Outcome|aTIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
208061|NCT01346592|O3|Outcome|TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
208062|NCT01346592|O2|Outcome|Comparator TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
208063|NCT01346592|O1|Outcome|aTIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
208064|NCT01346592|O2|Outcome|Comparator TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
208065|NCT01346592|O1|Outcome|TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
208066|NCT01346592|O2|Outcome|Comparator TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
208067|NCT01346592|O1|Outcome|TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
208068|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208069|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208070|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208071|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
208072|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
208073|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
208074|NCT01346592|E3|Reported Event|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208075|NCT01346592|E2|Reported Event|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208076|NCT01346592|E1|Reported Event|ATIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
208077|NCT01346514|B3|Baseline|Total|Total of all reporting groups
208078|NCT01346514|B2|Baseline|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
208079|NCT01346514|B1|Baseline|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
208080|NCT01346514|P2|Participant Flow|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
208081|NCT01346514|P1|Participant Flow|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
208082|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
208083|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
208084|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
208085|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
208086|NCT01346514|O2|Outcome|Arm 2/Housing Support Group (HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
208087|NCT01346514|O1|Outcome|Arm 1/Addiction Housing Case Management (AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
208088|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
208089|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
208820|NCT01344447|O2|Outcome|Unenhanced MRA|
208090|NCT01346514|O2|Outcome|Arm 2/Housing Support Group (HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
208091|NCT01346514|O1|Outcome|Arm 1/Addiction Housing Case Management (AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
208092|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
208093|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
208094|NCT01346514|O2|Outcome|Arm 2/Housing Support Group (HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
208095|NCT01346514|O1|Outcome|Arm 1/Addiction Housing Case Management (AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
208096|NCT01346514|E2|Reported Event|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
208097|NCT01346514|E1|Reported Event|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
208098|NCT01346501|B3|Baseline|Total|Total of all reporting groups
208099|NCT01346501|B2|Baseline|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
208100|NCT01346501|B1|Baseline|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
208101|NCT01346501|P2|Participant Flow|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
208102|NCT01346501|P1|Participant Flow|Adalimumab|Participants with Rheumatoid Arthritis (RA) who continued adalimumab treatment after completion of study M06-859 (HOPEFUL I study; NCT00870467), participated in the observational period of studies P12-069 (HOPEFUL II study; NCT01163292) and P12-707 (HOPEFUL III study; NCT01346501).
208103|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707.
208104|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
208105|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
208106|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
208107|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
208108|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
208109|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
208821|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208111|NCT01346501|O1|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and sustained low disease activity (defined as DAS28-CRP score <3.2 at Week 46 and Week 52), participated in the observational period of studies P12-069 and P12-707.
208112|NCT01346501|E2|Reported Event|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707
208113|NCT01346501|E1|Reported Event|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707
208114|NCT01346488|B1|Baseline|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208115|NCT01346488|P1|Participant Flow|Participants Receiving Adalimumab|Participants with rheumatoid arthritis (RA) treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208116|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208117|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208118|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208119|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208120|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208121|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208122|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208123|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208124|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208125|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208126|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208127|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208128|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208129|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208130|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208131|NCT01346488|E1|Reported Event|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
208132|NCT01346475|B3|Baseline|Total|Total of all reporting groups
208133|NCT01346475|B2|Baseline|High Dose Valacyclovir|
208134|NCT01346475|B1|Baseline|Valacyclovir|
208136|NCT01346475|P1|Participant Flow|Standard-dose Valacyclovir First Then High-dose Valacyclovir|Standard-dose valacyclovir (500 mg daily) for 5 weeks followed by 1 week wash-out and then high-dose valacyclovir (1 gram three times daily) for 5 weeks
208137|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
208138|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
208139|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
208140|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
208141|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
208142|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
208143|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
208144|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
208145|NCT01346475|E2|Reported Event|High Dose Valacyclovir|
208146|NCT01346475|E1|Reported Event|Valacyclovir|
208147|NCT01346397|B3|Baseline|Total|Total of all reporting groups
208148|NCT01346397|B2|Baseline|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered
cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
208149|NCT01346397|B1|Baseline|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
208150|NCT01346397|P2|Participant Flow|Tacrolimus Group|tacrolimus group - after Campath induction tacrolimus will be administered
208151|NCT01346397|P1|Participant Flow|Cyclosporine Group|cyclosporine group - after Campath induction cyclosporine will be administered
208152|NCT01346397|O2|Outcome|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered
cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
208153|NCT01346397|O1|Outcome|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
208154|NCT01346397|O2|Outcome|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered
cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
208155|NCT01346397|O1|Outcome|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
208156|NCT01346397|E2|Reported Event|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered
cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
208157|NCT01346397|E1|Reported Event|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
208158|NCT01346293|B3|Baseline|Total|Total of all reporting groups
208159|NCT01346293|B2|Baseline|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208160|NCT01346293|B1|Baseline|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208161|NCT01346293|P2|Participant Flow|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208162|NCT01346293|P1|Participant Flow|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208163|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208164|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208165|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208166|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208167|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208168|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208169|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208170|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208171|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208172|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208173|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208174|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208175|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208176|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208177|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208178|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208179|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208180|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208181|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208182|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208183|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208184|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208185|NCT01346293|E2|Reported Event|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
208186|NCT01346293|E1|Reported Event|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
208187|NCT01346176|B4|Baseline|Total|Total of all reporting groups
208188|NCT01346176|B3|Baseline|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
208189|NCT01346176|B2|Baseline|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
208190|NCT01346176|B1|Baseline|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
208191|NCT01346176|P3|Participant Flow|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
208192|NCT01346176|P2|Participant Flow|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
208193|NCT01346176|P1|Participant Flow|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
208194|NCT01346176|O3|Outcome|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
208195|NCT01346176|O2|Outcome|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
208196|NCT01346176|O1|Outcome|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
208197|NCT01346176|O3|Outcome|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
208198|NCT01346176|O2|Outcome|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
208199|NCT01346176|O1|Outcome|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
208200|NCT01346176|E3|Reported Event|Positive Default|
208201|NCT01346176|E2|Reported Event|Negative Default|
208202|NCT01346176|E1|Reported Event|Forced Choice|
208203|NCT01346085|B1|Baseline|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
208204|NCT01346085|P1|Participant Flow|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
208205|NCT01346085|O1|Outcome|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
208238|NCT01345929|O1|Outcome|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days
CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
208239|NCT01345929|O2|Outcome|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
208240|NCT01345929|O1|Outcome|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days
CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
208206|NCT01346085|O1|Outcome|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
208207|NCT01346085|E1|Reported Event|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
208208|NCT01346072|B3|Baseline|Total|Total of all reporting groups
208209|NCT01346072|B2|Baseline|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration
Low Copeptin < 10 pmol/L at baseline"
208210|NCT01346072|B1|Baseline|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration
High Copeptin ≥ 10 pmol/L at baseline"
208211|NCT01346072|P2|Participant Flow|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration
Low Copeptin < 10 pmol/L at baseline"
208212|NCT01346072|P1|Participant Flow|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration
High Copeptin ≥ 10 pmol/L at baseline"
208213|NCT01346072|O2|Outcome|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration
Low Copeptin < 10 pmol/L at baseline"
208214|NCT01346072|O1|Outcome|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration
High Copeptin ≥ 10 pmol/L at baseline"
208215|NCT01346072|O2|Outcome|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration
Low Copeptin < 10 pmol/L at baseline"
208216|NCT01346072|O1|Outcome|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration
High Copeptin ≥ 10 pmol/L at baseline"
208217|NCT01346072|E2|Reported Event|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration
Low Copeptin < 10 pmol/L at baseline"
208218|NCT01346072|E1|Reported Event|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration
High Copeptin ≥ 10 pmol/L at baseline"
208219|NCT01346059|B3|Baseline|Total|Total of all reporting groups
208220|NCT01346059|B2|Baseline|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.
Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
208221|NCT01346059|B1|Baseline|Saline|"The saline arm will receive normal saline through the catheter as a placebo.
Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
208222|NCT01346059|P2|Participant Flow|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.
Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
208223|NCT01346059|P1|Participant Flow|Saline|"The saline arm will receive normal saline through the catheter as a placebo.
Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
208224|NCT01346059|O2|Outcome|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.
Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
208225|NCT01346059|O1|Outcome|Saline|"The saline arm will receive normal saline through the catheter as a placebo.
Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
208226|NCT01346059|O2|Outcome|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.
Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
208227|NCT01346059|O1|Outcome|Saline|"The saline arm will receive normal saline through the catheter as a placebo.
Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
208228|NCT01346059|O2|Outcome|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.
Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
208229|NCT01346059|O1|Outcome|Saline|"The saline arm will receive normal saline through the catheter as a placebo.
Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
208230|NCT01346059|E2|Reported Event|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.
Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
208231|NCT01346059|E1|Reported Event|Saline|"The saline arm will receive normal saline through the catheter as a placebo.
Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
208232|NCT01345929|B3|Baseline|Total|Total of all reporting groups
208233|NCT01345929|B2|Baseline|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
208234|NCT01345929|B1|Baseline|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days
CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
208235|NCT01345929|P2|Participant Flow|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days
Of the 1083 subjects in the integrated analysis set, 535 received levofloxacin."
208236|NCT01345929|P1|Participant Flow|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days
CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days
Of the 1083 subjects in the integrated analysis set, 533 received CXA."
208241|NCT01345929|E2|Reported Event|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
208242|NCT01345929|E1|Reported Event|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days
CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
208243|NCT01345786|B5|Baseline|Total|Total of all reporting groups
208244|NCT01345786|B4|Baseline|Part 2 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
208245|NCT01345786|B3|Baseline|Part 2 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
208246|NCT01345786|B2|Baseline|Part 1 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
208247|NCT01345786|B1|Baseline|Part 1 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
208248|NCT01345786|P4|Participant Flow|Part 2 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
208249|NCT01345786|P3|Participant Flow|Part 2 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
208250|NCT01345786|P2|Participant Flow|Part 1 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
208251|NCT01345786|P1|Participant Flow|Part 1 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
208252|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208253|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208254|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208255|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208256|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208257|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208258|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208318|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208259|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208260|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208261|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208262|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208263|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208264|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208265|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208266|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208267|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208268|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208269|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208270|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208271|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208272|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208273|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208274|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208275|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208319|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
208276|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208277|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208278|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208279|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208280|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208281|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208282|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208283|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208284|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208285|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208286|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208287|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208288|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208289|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208290|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208291|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208292|NCT01345786|E4|Reported Event|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208320|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208293|NCT01345786|E3|Reported Event|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
208294|NCT01345786|E2|Reported Event|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208295|NCT01345786|E1|Reported Event|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
208296|NCT01345721|B4|Baseline|Total|Total of all reporting groups
208297|NCT01345721|B3|Baseline|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
208298|NCT01345721|B2|Baseline|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208299|NCT01345721|B1|Baseline|MenACWY (2 Primary +1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208300|NCT01345721|P3|Participant Flow|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
208301|NCT01345721|P2|Participant Flow|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208302|NCT01345721|P1|Participant Flow|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208303|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
208304|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208305|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208306|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
208307|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208308|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208309|NCT01345721|O2|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study
208310|NCT01345721|O1|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study
208311|NCT01345721|O2|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study
208312|NCT01345721|O1|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study
208313|NCT01345721|O1|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
208314|NCT01345721|O1|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
208315|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208316|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208317|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208363|NCT01345630|B3|Baseline|Total|Total of all reporting groups
209292|NCT01342523|B25|Baseline|No CIS/Loz/no Emails/Full Website/Full Booklet|
208321|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208322|NCT01345721|O3|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
208323|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208324|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208325|NCT01345721|E3|Reported Event|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
208326|NCT01345721|E2|Reported Event|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208327|NCT01345721|E1|Reported Event|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
208328|NCT01345682|B3|Baseline|Total|Total of all reporting groups
208329|NCT01345682|B2|Baseline|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208330|NCT01345682|B1|Baseline|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208331|NCT01345682|P2|Participant Flow|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208332|NCT01345682|P1|Participant Flow|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208333|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208334|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208335|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208336|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208337|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208338|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208339|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208340|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208341|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208342|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208425|NCT01345591|O3|Outcome|Fat Grafting_3 Months Post op|quality of life measurement at 3 months post-op to include SWAP, COPE and CSQ-8 questionnaires
208343|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208344|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208345|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208346|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208347|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208348|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208349|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208350|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208351|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208352|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208353|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208354|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208355|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208356|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208357|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208358|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208359|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208360|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208361|NCT01345682|E2|Reported Event|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208362|NCT01345682|E1|Reported Event|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
208364|NCT01345630|B2|Baseline|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208365|NCT01345630|B1|Baseline|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208366|NCT01345630|P2|Participant Flow|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208367|NCT01345630|P1|Participant Flow|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208368|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208369|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208370|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208371|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208372|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208373|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208374|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208375|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208376|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208377|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208378|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208379|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208380|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208381|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208382|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208383|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208384|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208385|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208386|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208387|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208388|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208389|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208390|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208391|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208392|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208393|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208426|NCT01345591|O2|Outcome|Fat Grafting_7-21 Days Post op|quality of life measurement at 7-21 days post-op to include SWAP, COPE and CSQ-8 questionnaires
208394|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208395|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208396|NCT01345630|O4|Outcome|FTC/TDF+DRV/r - Failure|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
208397|NCT01345630|O3|Outcome|FTC/TDF+DRV/r - Baseline|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results by baseline.
208398|NCT01345630|O2|Outcome|MVC+DRV/r - Failure|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
208399|NCT01345630|O1|Outcome|MVC+DRV/r - Baseline|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results by baseline.
208400|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208401|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208402|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208403|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208404|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208405|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208406|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208407|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208408|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208409|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208410|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208411|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208412|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208413|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208414|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208415|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208416|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208417|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208418|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208419|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208420|NCT01345630|E2|Reported Event|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
208421|NCT01345630|E1|Reported Event|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
208422|NCT01345591|B1|Baseline|Fat Grafting|Fat Grafting for facial trauma
208423|NCT01345591|P1|Participant Flow|Fat Grafting|fat grafting for facial trauma
208424|NCT01345591|O4|Outcome|Fat Grafting_9 Months Post-op|quality of life measurement at 9 months post-op to include SWAP, COPE and CSQ-8 questionnaires
208427|NCT01345591|O1|Outcome|Fat Grafting_evaluation at Baseline|quality of life measurement at baseline to include SWAP, COPE and CSQ-8 questionnaires
208428|NCT01345591|O2|Outcome|Fat Graft Volume at 9 Months|fat grafting for facial trauma, volume measured at 9 months post-op
208429|NCT01345591|O1|Outcome|Fat Graft Volume at 3 Months|fat grafting for facial trauma, volume measured at 3 months post-op
208430|NCT01345591|E1|Reported Event|Fat Grafting|fat grafting for facial trauma
208431|NCT01345318|B1|Baseline|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
208432|NCT01345318|P1|Participant Flow|PF-04236921|All participants entering this study were given a 50 mg subcutaneous (SC) dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
208433|NCT01345318|O1|Outcome|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
208434|NCT01345318|O1|Outcome|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
208435|NCT01345318|E1|Reported Event|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
208436|NCT01345292|B4|Baseline|Total|Total of all reporting groups
208437|NCT01345292|B3|Baseline|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
208438|NCT01345292|B2|Baseline|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
208439|NCT01345292|B1|Baseline|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
208440|NCT01345292|P3|Participant Flow|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
208441|NCT01345292|P2|Participant Flow|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
208442|NCT01345292|P1|Participant Flow|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
208443|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
208444|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
208445|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
208446|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
208447|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
208448|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
208449|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
208450|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
208451|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
208452|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
208453|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
208454|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
208455|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
208456|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
208457|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
208458|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
208459|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
208460|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
208461|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
208462|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
208463|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
208464|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
208465|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
208466|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
208467|NCT01345292|E3|Reported Event|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
208468|NCT01345292|E2|Reported Event|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
208469|NCT01345292|E1|Reported Event|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
208470|NCT01345253|B3|Baseline|Total|Total of all reporting groups
208471|NCT01345253|B2|Baseline|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208472|NCT01345253|B1|Baseline|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208473|NCT01345253|P2|Participant Flow|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208474|NCT01345253|P1|Participant Flow|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208475|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208476|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208477|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208478|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208479|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208480|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208481|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208482|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208483|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208484|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208485|NCT01345253|E2|Reported Event|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208486|NCT01345253|E1|Reported Event|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
208487|NCT01345240|B6|Baseline|Total|Total of all reporting groups
208488|NCT01345240|B5|Baseline|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208489|NCT01345240|B4|Baseline|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208490|NCT01345240|B3|Baseline|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
209123|NCT01342965|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
208491|NCT01345240|B2|Baseline|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208492|NCT01345240|B1|Baseline|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208493|NCT01345240|P5|Participant Flow|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208494|NCT01345240|P4|Participant Flow|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208495|NCT01345240|P3|Participant Flow|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208496|NCT01345240|P2|Participant Flow|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208497|NCT01345240|P1|Participant Flow|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208604|NCT01345123|P1|Participant Flow|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
208605|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
209293|NCT01342523|B24|Baseline|No CIS/Loz/Emails/Lite Website/Full Booklet|
208498|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208499|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208500|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208501|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208502|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208503|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208504|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208540|NCT01345240|O2|Outcome|Engerix B Group|Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B™ as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™ and of vaccines against yellow fever and against measles. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208505|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208506|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208507|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208508|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208509|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208510|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208511|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208589|NCT01345162|B3|Baseline|Total|Total of all reporting groups
208590|NCT01345162|B2|Baseline|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
208591|NCT01345162|B1|Baseline|Ketorolac|"Ketorolac 10mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
209294|NCT01342523|B23|Baseline|No CIS/Loz/Emails/Full Website/Brief Booklet|
208512|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208513|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208514|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208515|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208516|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208517|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208518|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208592|NCT01345162|P2|Participant Flow|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
208593|NCT01345162|P1|Participant Flow|Ketorolac|"Ketorolac 10mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
208594|NCT01345162|O2|Outcome|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
208519|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208520|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208521|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208522|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208523|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208524|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208525|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208595|NCT01345162|O1|Outcome|Ketorolac|"Ketorolac 10mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
208596|NCT01345162|E2|Reported Event|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
208597|NCT01345162|E1|Reported Event|Ketorolac|"Ketorolac 10mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
208598|NCT01345123|B4|Baseline|Total|Total of all reporting groups
208526|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208527|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208528|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208529|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208530|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208531|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208532|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208599|NCT01345123|B3|Baseline|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
208600|NCT01345123|B2|Baseline|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
208729|NCT01344538|B1|Baseline|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
208730|NCT01344538|P2|Participant Flow|Lactose Capsule|Placebo Capsule : 2.0 g per day
208533|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208534|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208535|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208536|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208537|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208538|NCT01345240|O2|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208539|NCT01345240|O1|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208601|NCT01345123|B1|Baseline|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
208602|NCT01345123|P3|Participant Flow|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
208731|NCT01344538|P1|Participant Flow|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
208541|NCT01345240|O1|Outcome|RTS,S Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208542|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208543|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208544|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208545|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208546|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208547|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208548|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
209295|NCT01342523|B22|Baseline|CIS/no Loz/no Email/Full Website/Full Booklet|
208549|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208550|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208551|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208552|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208553|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208554|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208555|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208556|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208557|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208558|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208559|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208560|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208561|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208562|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208563|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208564|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208565|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208566|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208567|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208568|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208569|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208570|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208571|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208572|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208573|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208574|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208575|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208576|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208577|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208578|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208579|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208580|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208603|NCT01345123|P2|Participant Flow|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
208581|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208582|NCT01345240|O2|Outcome|Engerix B Group|Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B™ as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™ and of vaccines against yellow fever and against measles. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208583|NCT01345240|O1|Outcome|RTS,S Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208584|NCT01345240|E5|Reported Event|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208585|NCT01345240|E4|Reported Event|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208586|NCT01345240|E3|Reported Event|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208587|NCT01345240|E2|Reported Event|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208588|NCT01345240|E1|Reported Event|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
208606|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
208607|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
208608|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
208609|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
208610|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
208611|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
208612|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
208613|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
208614|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
208615|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
208616|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
208617|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
208618|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
208619|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
208620|NCT01345123|E3|Reported Event|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
208621|NCT01345123|E2|Reported Event|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
208622|NCT01345123|E1|Reported Event|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
208623|NCT01345058|B3|Baseline|Total|Total of all reporting groups
208624|NCT01345058|B2|Baseline|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
208625|NCT01345058|B1|Baseline|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
208626|NCT01345058|P2|Participant Flow|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
208627|NCT01345058|P1|Participant Flow|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
208628|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
208629|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
208630|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
208631|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
208632|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
208633|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
208732|NCT01344538|O2|Outcome|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
208634|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
208635|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
208636|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
208637|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
208638|NCT01345058|E2|Reported Event|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
208639|NCT01345058|E1|Reported Event|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
208640|NCT01344876|B1|Baseline|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
OPB-51602: once daily during the treatment period"
208641|NCT01344876|P5|Participant Flow|OPB-51602: 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208642|NCT01344876|P4|Participant Flow|OPB-51602: 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208643|NCT01344876|P3|Participant Flow|OPB-51602: 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208644|NCT01344876|P2|Participant Flow|OPB-51602: 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208645|NCT01344876|P1|Participant Flow|OPB-51602: 1mg/Day|OPB-51602: 1, 2, 3,4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208646|NCT01344876|O5|Outcome|OPB-51602 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208647|NCT01344876|O4|Outcome|OPB-51602 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208648|NCT01344876|O3|Outcome|OPB-51602 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208649|NCT01344876|O2|Outcome|OPB-51602 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208650|NCT01344876|O1|Outcome|OPB-51602 1m/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208651|NCT01344876|O1|Outcome|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
OPB-51602: once daily during the treatment period"
208652|NCT01344876|O1|Outcome|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
OPB-51602: once daily during the treatment period"
208653|NCT01344876|E5|Reported Event|OPB-51602 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208654|NCT01344876|E4|Reported Event|OPB-51602 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208655|NCT01344876|E3|Reported Event|OPB-51602 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208656|NCT01344876|E2|Reported Event|OPB-51602 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208657|NCT01344876|E1|Reported Event|OPB-51602 1mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
208658|NCT01344824|B1|Baseline|Single Arm Trial|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
208659|NCT01344824|P1|Participant Flow|Bevacizumab, Carboplatin, and Pemetrexed Disodium, With Option|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
208660|NCT01344824|O1|Outcome|Bevacizumab, Carboplatin, and Pemetrexed Disodium, With Option|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
208661|NCT01344824|O1|Outcome|Single Arm Trial|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
208662|NCT01344824|O1|Outcome|Single Arm Trial|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
208663|NCT01344824|E1|Reported Event|Single Arm Trial|"Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)"
208664|NCT01344759|B3|Baseline|Total|Total of all reporting groups
208733|NCT01344538|O1|Outcome|Lactose Capsule|Placebo Capsule : 2.0 g per day
208734|NCT01344538|E2|Reported Event|Lactose Capsule|Placebo Capsule: 2.0 g per day
208665|NCT01344759|B2|Baseline|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
208666|NCT01344759|B1|Baseline|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
208667|NCT01344759|P2|Participant Flow|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
208668|NCT01344759|P1|Participant Flow|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
208669|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208670|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208671|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208672|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208673|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208674|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208675|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208676|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208677|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208678|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208679|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208680|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208681|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208682|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208683|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208684|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208685|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208686|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208687|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208688|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208689|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208690|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208691|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive Propofol."
208692|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)
Additionally this patient was assigned to receive DEX."
208693|NCT01344759|O2|Outcome|Dexmedetomidine|"Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump (low dose). Baseline airway images are obtained during this time.
If a subject moves during baseline images a bolus of DEX 0.5 mcg/kg will be given over 3 minutes and infusion rate will be increased to 1.5 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.
After the initial set of airway images are obtained, a 2 mcg/kg bolus of DEX will be given over 10 minutes followed by an increase in the infusion rate to 3 mcg/kg/hr (high dose)."
208694|NCT01344759|O1|Outcome|Propofol|"Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump (Low dose). Baseline airway images are obtained during this time.
If a subject moves during baseline images a bolus of Propofol 0.5 mcg/kg will be given over 10 seconds and infusion rate will be increased to 120 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.
After the initial set of airway images are obtained, a bolus dose of propofol 2 mcg/kg will be given over 2 minutes followed by an increase in the infusion rate to 200 mcg/kg/hr (high dose)."
208695|NCT01344759|E2|Reported Event|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
208696|NCT01344759|E1|Reported Event|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
208697|NCT01344629|B3|Baseline|Total|Total of all reporting groups
208698|NCT01344629|B2|Baseline|Treatment Sequence B|
208699|NCT01344629|B1|Baseline|Treatment Sequence A|
208700|NCT01344629|P2|Participant Flow|Treatment Sequence B|Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
208701|NCT01344629|P1|Participant Flow|Treatment Sequence A|T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet
208702|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
208703|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
208704|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
208705|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
208706|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
208707|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
208708|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
208709|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
208710|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
208711|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
208712|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
208713|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
208714|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
208715|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
208716|NCT01344629|E2|Reported Event|Treatment Sequence B|Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
208717|NCT01344629|E1|Reported Event|Treatment Sequence A|T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet
208718|NCT01344616|B3|Baseline|Total|Total of all reporting groups
208719|NCT01344616|B2|Baseline|Lifestyle Counseling|"computer-based clinical support to patient
lifestyle support: computer-based lifestyle improvement support and clinician support"
208720|NCT01344616|B1|Baseline|Usual Clinical Care|usual clinical care with no intervention
208721|NCT01344616|P2|Participant Flow|Lifestyle Counseling|"computer-based clinical support to patient
lifestyle support: computer-based lifestyle improvement support and clinician support"
208722|NCT01344616|P1|Participant Flow|Usual Clinical Care|usual clinical care with no intervention
208723|NCT01344616|O2|Outcome|Lifestyle Counseling|"computer-based clinical support to patient
lifestyle support: computer-based lifestyle improvement support and clinician support"
208724|NCT01344616|O1|Outcome|Usual Clinical Care|usual clinical care with no intervention
208725|NCT01344616|E2|Reported Event|Lifestyle Counseling|"computer-based clinical support to patient
lifestyle support: computer-based lifestyle improvement support and clinician support"
208726|NCT01344616|E1|Reported Event|Usual Clinical Care|usual clinical care with no intervention
208727|NCT01344538|B3|Baseline|Total|Total of all reporting groups
208728|NCT01344538|B2|Baseline|Lactose Capsule|Placebo Capsule : 2.0 g per day
209296|NCT01342523|B21|Baseline|CIS/no Loz/Emails/Lite Website/Full Booklet|
208736|NCT01344460|B1|Baseline|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
208737|NCT01344460|P1|Participant Flow|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
208738|NCT01344460|O2|Outcome|Unenhanced MRA|
208739|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208740|NCT01344460|O2|Outcome|Unenhanced MRA|
208741|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208742|NCT01344460|O2|Outcome|Unenhanced MRA|
208743|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208744|NCT01344460|O2|Outcome|Unenhanced MRA|
208745|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208746|NCT01344460|O2|Outcome|Unenhanced MRA|
208747|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208748|NCT01344460|O2|Outcome|Unenhanced MRA|
208749|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208750|NCT01344460|O2|Outcome|Unenhanced MRA|
208751|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208752|NCT01344460|O2|Outcome|Unenhanced MRA|
208753|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208754|NCT01344460|O2|Outcome|Unenhanced MRA|
208755|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208756|NCT01344460|O2|Outcome|Unenhanced MRA|
208757|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208758|NCT01344460|O2|Outcome|Unenhanced MRA|
208759|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208760|NCT01344460|O2|Outcome|Unenhanced MRA|
208761|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208762|NCT01344460|O2|Outcome|Unenhanced MRA|
208763|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208764|NCT01344460|O2|Outcome|Unenhanced MRA|
208765|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208766|NCT01344460|O3|Outcome|Computed Tomographic Angiography|
208767|NCT01344460|O2|Outcome|Unenhanced MRA|
208768|NCT01344460|O1|Outcome|Gadobutrol-Enhanced MRA|
208769|NCT01344460|O1|Outcome|Computed Tomographic Angiography (CTA)|
208770|NCT01344460|O2|Outcome|Unenhanced MRA|
208771|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208772|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208773|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208774|NCT01344460|O2|Outcome|Unenhanced MRA|
208775|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208776|NCT01344460|O2|Outcome|Unenhanced MRA|
208777|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208778|NCT01344460|O2|Outcome|Unenhanced MRA|
208779|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
208780|NCT01344460|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
208781|NCT01344447|B1|Baseline|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
208782|NCT01344447|P1|Participant Flow|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
208783|NCT01344447|O2|Outcome|Unenhanced MRA|
208784|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208785|NCT01344447|O2|Outcome|Unenhanced MRA|
208786|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208787|NCT01344447|O2|Outcome|Unenhanced MRA|
208788|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208789|NCT01344447|O2|Outcome|Unenhanced MRA|
208790|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208791|NCT01344447|O2|Outcome|Unenhanced MRA|
208792|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208793|NCT01344447|O2|Outcome|Unenhanced MRA|
208794|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208795|NCT01344447|O2|Outcome|Unenhanced MRA|
208796|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208797|NCT01344447|O2|Outcome|Unenhanced MRA|
208798|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208799|NCT01344447|O2|Outcome|Unenhanced MRA|
208800|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208801|NCT01344447|O2|Outcome|Unenhanced MRA|
208802|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208803|NCT01344447|O2|Outcome|Unenhanced MRA|
208804|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208805|NCT01344447|O2|Outcome|Unenhanced MRA|
208806|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208807|NCT01344447|O2|Outcome|Unenhanced MRA|
208808|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208809|NCT01344447|O2|Outcome|Unenhanced MRA|
208810|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
208811|NCT01344447|O3|Outcome|Computed Tomographic Angiography|
208822|NCT01344447|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
208823|NCT01344369|B3|Baseline|Total|Total of all reporting groups
208824|NCT01344369|B2|Baseline|FEMCON® Fe (Reference) First|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
208825|NCT01344369|B1|Baseline|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
208826|NCT01344369|P2|Participant Flow|FEMCON® Fe (Reference) First|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
208827|NCT01344369|P1|Participant Flow|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
208828|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
208829|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
208830|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
208831|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
208832|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
208833|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
208834|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
208835|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
208836|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
208837|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
208838|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
208839|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
208840|NCT01344369|E2|Reported Event|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
208841|NCT01344369|E1|Reported Event|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
208842|NCT01344161|B3|Baseline|Total|Total of all reporting groups
208843|NCT01344161|B2|Baseline|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
208844|NCT01344161|B1|Baseline|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
208845|NCT01344161|P2|Participant Flow|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
208846|NCT01344161|P1|Participant Flow|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
208847|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
208848|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
208849|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
208850|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
208851|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
208852|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
208853|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
208854|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
208855|NCT01344161|E2|Reported Event|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
208856|NCT01344161|E1|Reported Event|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
208857|NCT01344057|B1|Baseline|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
208858|NCT01344057|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
208859|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
208860|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
208861|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
209167|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
208862|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
208863|NCT01344057|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of trivalent subunit inactivated adjuvanted influenza vaccine FLUAD during the vaccination visit, according to the study protocol (follow-up period: until day 22).
208864|NCT01343901|B1|Baseline|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208865|NCT01343901|P1|Participant Flow|Bevacizumab|All participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases for whom bevacizumab (Avastin) was administered as part of first line treatment for potentially resectable liver metastases as per treating physician discretion. All concomitant medications as used in daily routine clinical practice were allowed.
208866|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208867|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208868|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208869|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208870|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208871|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208872|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208873|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208874|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208875|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208876|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208877|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208878|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208879|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208880|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208881|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208882|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208883|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208884|NCT01343901|E1|Reported Event|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
208885|NCT01343888|B4|Baseline|Total|Total of all reporting groups
208886|NCT01343888|B3|Baseline|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208887|NCT01343888|B2|Baseline|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208888|NCT01343888|B1|Baseline|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208889|NCT01343888|P3|Participant Flow|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208890|NCT01343888|P2|Participant Flow|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48.
208891|NCT01343888|P1|Participant Flow|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48.
208892|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208893|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208894|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208895|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208896|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208897|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208898|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208899|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208900|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208901|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208902|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208903|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208904|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208905|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208906|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208907|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208908|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208909|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208910|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208911|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208912|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208913|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208914|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208915|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208916|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208917|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208918|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208919|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208920|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208921|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208922|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208923|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208924|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208925|NCT01343888|E3|Reported Event|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
208926|NCT01343888|E2|Reported Event|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
208927|NCT01343888|E1|Reported Event|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
208928|NCT01343823|B5|Baseline|Total|Total of all reporting groups
208929|NCT01343823|B4|Baseline|Placebo|
208930|NCT01343823|B3|Baseline|Ecallantide 60 mg|
208931|NCT01343823|B2|Baseline|Ecallantide 30 mg|
208932|NCT01343823|B1|Baseline|Ecallantide 10 mg|
208933|NCT01343823|P4|Participant Flow|Ecallantide 60mg|60 mg administered as two 30 mg SC injections of ecallantide
208934|NCT01343823|P3|Participant Flow|Ecallantide 30 mg|30 mg administered as one 30 mg SC injection of ecallantide and one matching placebo
208935|NCT01343823|P2|Participant Flow|Ecallantide 10 mg|10 mg administered as one 10 mg SC injection of ecallantide and one matching placebo
208936|NCT01343823|P1|Participant Flow|Placebo|Administered by two subcutaneous injections.
208937|NCT01343823|O4|Outcome|Ecallantide 60 mg|
208938|NCT01343823|O3|Outcome|Ecallantide 30 mg|
208939|NCT01343823|O2|Outcome|Ecallantide 10 mg|
208940|NCT01343823|O1|Outcome|Placebo|
208941|NCT01343823|O4|Outcome|Ecallantide 60 mg|
208942|NCT01343823|O3|Outcome|Ecallantide 30 mg|
208943|NCT01343823|O2|Outcome|Ecallantide 10 mg|
208944|NCT01343823|O1|Outcome|Placebo|
208945|NCT01343823|E4|Reported Event|Placebo|
208946|NCT01343823|E3|Reported Event|Ecallantide 60 mg|
208947|NCT01343823|E2|Reported Event|Ecallantide 30 mg|
208948|NCT01343823|E1|Reported Event|Ecallantide 10 mg|
208949|NCT01343667|B3|Baseline|Total|Total of all reporting groups
208950|NCT01343667|B2|Baseline|GEF EPD|"Carotid artery stenting with Gore Embolic Filter
Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
208951|NCT01343667|B1|Baseline|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System
Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
208952|NCT01343667|P2|Participant Flow|GEF EPD|"Carotid artery stenting with Gore Embolic Filter
Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
208953|NCT01343667|P1|Participant Flow|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System
Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
208954|NCT01343667|O2|Outcome|GEF EPD|"Carotid artery stenting with Gore Embolic Filter embolic protection device
Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
208955|NCT01343667|O1|Outcome|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System embolic protection device
Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
208956|NCT01343667|E2|Reported Event|GEF EPD|"Carotid artery stenting with Gore Embolic Filter
Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
208957|NCT01343667|E1|Reported Event|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System
Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
208958|NCT01343485|B3|Baseline|Total|Total of all reporting groups
208959|NCT01343485|B2|Baseline|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.
Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
208960|NCT01343485|B1|Baseline|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
209168|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
208961|NCT01343485|P2|Participant Flow|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.
Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
208962|NCT01343485|P1|Participant Flow|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
208963|NCT01343485|O2|Outcome|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.
Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
208964|NCT01343485|O1|Outcome|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
208965|NCT01343485|E2|Reported Event|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.
Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
208966|NCT01343485|E1|Reported Event|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
208967|NCT01343368|B3|Baseline|Total|Total of all reporting groups
208968|NCT01343368|B2|Baseline|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208969|NCT01343368|B1|Baseline|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208970|NCT01343368|P2|Participant Flow|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208971|NCT01343368|P1|Participant Flow|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208972|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208973|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208974|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208975|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
209051|NCT01343056|P4|Participant Flow|Educator Support Follow up|A diabetes educator provided support to patients with periodic phone calls. Diabetes educators received training in ways to improve patient empowerment and best support their patients following diabetes education.
208976|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208977|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208978|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208979|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208980|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208981|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208982|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208983|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208984|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208985|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208986|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208987|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208988|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208989|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208990|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208991|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208992|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208993|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208994|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208995|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208996|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208997|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
208998|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
208999|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
209000|NCT01343368|O2|Outcome|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
209001|NCT01343368|O1|Outcome|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
209002|NCT01343368|E2|Reported Event|Observational Arm|"Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease."
209003|NCT01343368|E1|Reported Event|Interventional - Received Leuprolide|"Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplant: Conventional bone marrow transplant regimen."
209004|NCT01343277|B3|Baseline|Total|Total of all reporting groups
209005|NCT01343277|B2|Baseline|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
209006|NCT01343277|B1|Baseline|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
209007|NCT01343277|P2|Participant Flow|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
209008|NCT01343277|P1|Participant Flow|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
209009|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
209010|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
209011|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
209012|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
209013|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
209014|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
209015|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
209016|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
209017|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
209018|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
209297|NCT01342523|B20|Baseline|CIS/no Loz/Emails/Full Website/Brief Booklet|
209019|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
209020|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
209021|NCT01343277|E2|Reported Event|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
209022|NCT01343277|E1|Reported Event|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
209023|NCT01343251|B3|Baseline|Total|Total of all reporting groups
209024|NCT01343251|B2|Baseline|Control|control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
209025|NCT01343251|B1|Baseline|HeRO Graft|patients who are evaluated and receive a HeRO graft implant for hemodialysis
209026|NCT01343251|P2|Participant Flow|Control|control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
209027|NCT01343251|P1|Participant Flow|HeRO Graft|patients who are evaluated and receive a Hemodialysis Reliable Outflow (HeRO) graft implant for hemodialysis
209028|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO Graft
209029|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
209030|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO Graft
209031|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
209032|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO
209033|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
209034|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive HeRO
209035|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
209036|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive HeRO
209037|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft Recipients
209038|NCT01343251|E2|Reported Event|Control|HeRO eligible patients who did not receive a HeRO Graft
209039|NCT01343251|E1|Reported Event|HeRO Graft|HeRO Graft recipients
209040|NCT01343082|B1|Baseline|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
209041|NCT01343082|P3|Participant Flow|Allocated to Tafluprost + Timolol|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5%.
209042|NCT01343082|P2|Participant Flow|Allocated to Timolol|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation).
209043|NCT01343082|P1|Participant Flow|Allocated to Tafluprost|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation) .
209044|NCT01343082|O1|Outcome|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
209045|NCT01343082|E1|Reported Event|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
209046|NCT01343056|B5|Baseline|Total|Total of all reporting groups
209047|NCT01343056|B4|Baseline|Educator Support Follow up|"A diabetes educator will provide follow up support.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209048|NCT01343056|B3|Baseline|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209049|NCT01343056|B2|Baseline|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209050|NCT01343056|B1|Baseline|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209052|NCT01343056|P3|Participant Flow|Usual Care|ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call was made by a diabetes educator.
209053|NCT01343056|P2|Participant Flow|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer met with the participant at their 6 week follow up visit and then called the participant monthly to monitor goal attainment."
209054|NCT01343056|P1|Participant Flow|Office Staff Follow up of Diabetes Education|A designee in the office shall be assigned to follow up with the patient for goal attainment. It was suggested that they phone the participant monthly. Staff also received training on how best to provide support to patients.
209055|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.
Educator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered."
209056|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.
Usual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management."
209057|NCT01343056|O2|Outcome|Peer Follow up Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.
Peer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
209058|NCT01343056|O1|Outcome|Office Staff Follow up Education|"A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.
Office Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
209059|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209060|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209061|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209062|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209063|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.
Educator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered."
209064|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.
Usual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management."
209065|NCT01343056|O2|Outcome|Peer Follow up Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.
Peer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
209066|NCT01343056|O1|Outcome|Office Staff Follow up Education|"A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.
Office Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
209067|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209068|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209069|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209169|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209070|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209071|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209072|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209073|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209074|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209075|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209076|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209077|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209078|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209079|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.
Educator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered."
209080|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.
Usual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management."
209081|NCT01343056|O2|Outcome|Peer Follow up Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.
Peer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
209082|NCT01343056|O1|Outcome|Office Staff Follow up Education|"A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.
Office Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
209083|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209084|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209085|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209086|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209087|NCT01343056|E4|Reported Event|Educator Support Follow up|"A diabetes educator will provide follow up support.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209088|NCT01343056|E3|Reported Event|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209089|NCT01343056|E2|Reported Event|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209090|NCT01343056|E1|Reported Event|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.
Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
209091|NCT01343004|B4|Baseline|Total|Total of all reporting groups
209092|NCT01343004|B3|Baseline|Teriparatide|"Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily"
209093|NCT01343004|B2|Baseline|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
209094|NCT01343004|B1|Baseline|Placebo|"Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily"
209095|NCT01343004|P3|Participant Flow|Teriparatide|"Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily"
209096|NCT01343004|P2|Participant Flow|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
209097|NCT01343004|P1|Participant Flow|Placebo|"Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily"
209098|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily"
209099|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
209100|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily"
209101|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily"
209102|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
209103|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily"
209104|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily"
209105|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
209106|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily"
209107|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily"
209108|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
209109|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily"
209110|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily"
209111|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
209112|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily"
209113|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily"
209114|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
209115|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily"
209116|NCT01343004|E3|Reported Event|Teriparatide|"Blinded until after randomization, then open-label
teriparatide: teriparatide 20 mcg subcutaneous daily"
209117|NCT01343004|E2|Reported Event|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
209118|NCT01343004|E1|Reported Event|Placebo|"Placebo identical in appearance to BA058 study drug
Placebo: Placebo 0 mcg subcutaneous daily"
209119|NCT01342965|B3|Baseline|Total|Total of all reporting groups
209120|NCT01342965|B2|Baseline|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
209121|NCT01342965|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
209122|NCT01342965|P2|Participant Flow|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
209170|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209124|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
209125|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
209126|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
209127|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
209128|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
209129|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
209130|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
209131|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
209132|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
209133|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
209134|NCT01342965|E2|Reported Event|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
209135|NCT01342965|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
209136|NCT01342926|B5|Baseline|Total|Total of all reporting groups
209137|NCT01342926|B4|Baseline|GSK933776 15 mg/kg|15 mg/kg administration of GSK933776 via intravenous infusion
209138|NCT01342926|B3|Baseline|GSK933776 6 mg/kg|6 mg/kg administration of GSK933776 via intravenous infusion
209139|NCT01342926|B2|Baseline|GSK933776 3 mg/kg|3 mg/kg administration of GSK933776 via intravenous infusion
209140|NCT01342926|B1|Baseline|Placebo|Placebo via intravenous infusion
209141|NCT01342926|P4|Participant Flow|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209142|NCT01342926|P3|Participant Flow|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209143|NCT01342926|P2|Participant Flow|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209144|NCT01342926|P1|Participant Flow|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209145|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209146|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209147|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209148|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209149|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209150|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209151|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209152|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209153|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209154|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209155|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209156|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209157|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209158|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209159|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209160|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209161|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209162|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209163|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209164|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209165|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209166|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209171|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209172|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209173|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209174|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209175|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209176|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209177|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209178|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209179|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209180|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209181|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209182|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209183|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209184|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209185|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209186|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209187|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209188|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209189|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209190|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209191|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209192|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209193|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209194|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209195|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209196|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209197|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209198|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209199|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209200|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209201|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209202|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209203|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209204|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209205|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209206|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209207|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209208|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209209|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209210|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209211|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209212|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209213|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209214|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209215|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209216|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209217|NCT01342926|E4|Reported Event|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209218|NCT01342926|E3|Reported Event|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
209219|NCT01342926|E2|Reported Event|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
209220|NCT01342926|E1|Reported Event|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
209221|NCT01342913|B3|Baseline|Total|Total of all reporting groups
209222|NCT01342913|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
209223|NCT01342913|B1|Baseline|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
209224|NCT01342913|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
209225|NCT01342913|P2|Participant Flow|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
209226|NCT01342913|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
209227|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
209228|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
209229|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
209230|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
209231|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
209232|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
209233|NCT01342913|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
209234|NCT01342913|E1|Reported Event|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
209235|NCT01342887|B1|Baseline|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.
cyclosporine: Given IV
pravastatin sodium: Given PO
mitoxantrone hydrochloride: Given IV
etoposide: Given IV
bone marrow aspiration: Correlative studies"
209236|NCT01342887|P1|Participant Flow|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.
cyclosporine: Given IV
pravastatin sodium: Given PO
mitoxantrone hydrochloride: Given IV
etoposide: Given IV
bone marrow aspiration: Correlative studies"
209288|NCT01342523|B29|Baseline|No CIS/Loz/Emails/Full Website/Full Booklet|
209237|NCT01342887|O1|Outcome|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.
cyclosporine: Given IV
pravastatin sodium: Given PO
mitoxantrone hydrochloride: Given IV
etoposide: Given IV
bone marrow aspiration: Correlative studies"
209238|NCT01342887|O1|Outcome|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.
cyclosporine: Given IV
pravastatin sodium: Given PO
mitoxantrone hydrochloride: Given IV
etoposide: Given IV
bone marrow aspiration: Correlative studies"
209239|NCT01342887|O1|Outcome|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.
cyclosporine: Given IV
pravastatin sodium: Given PO
mitoxantrone hydrochloride: Given IV
etoposide: Given IV
bone marrow aspiration: Correlative studies"
209240|NCT01342887|O1|Outcome|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.
cyclosporine: Given IV
pravastatin sodium: Given PO
mitoxantrone hydrochloride: Given IV
etoposide: Given IV
bone marrow aspiration: Correlative studies"
209241|NCT01342887|E1|Reported Event|Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)|"Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.
cyclosporine: Given IV
pravastatin sodium: Given PO
mitoxantrone hydrochloride: Given IV
etoposide: Given IV
bone marrow aspiration: Correlative studies"
209242|NCT01342770|B1|Baseline|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209243|NCT01342770|P1|Participant Flow|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209244|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209245|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209246|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209247|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209248|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209249|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209250|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209251|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209252|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209253|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209254|NCT01342770|E1|Reported Event|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
209255|NCT01342757|B1|Baseline|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.
Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
209256|NCT01342757|P1|Participant Flow|Vorinostat and Temozolomide|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.
Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
209289|NCT01342523|B28|Baseline|CIS/Loz/Emails/Lite Website/Full Booklet|
209290|NCT01342523|B27|Baseline|CIS/Loz/Emails/Full Website/Brief Booklet|
209291|NCT01342523|B26|Baseline|no CIS/no Loz/Emails/Full Website/Full Booklet|
209257|NCT01342757|O1|Outcome|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.
Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
209258|NCT01342757|O1|Outcome|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.
Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
209259|NCT01342757|E1|Reported Event|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.
Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
209260|NCT01342666|B3|Baseline|Total|Total of all reporting groups
209261|NCT01342666|B2|Baseline|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
209262|NCT01342666|B1|Baseline|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
209263|NCT01342666|P2|Participant Flow|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
209264|NCT01342666|P1|Participant Flow|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
209265|NCT01342666|O2|Outcome|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
209266|NCT01342666|O1|Outcome|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
209267|NCT01342666|E2|Reported Event|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
209268|NCT01342666|E1|Reported Event|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
209269|NCT01342640|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
209270|NCT01342640|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) at a starting dose of 1.2 micrograms per kilogram (mcg/kg) administered via subcutaneous (SC) injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s hemoglobin (Hb) level.
209271|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
209272|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
209273|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
209274|NCT01342640|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
209275|NCT01342549|B3|Baseline|Total|Total of all reporting groups
209276|NCT01342549|B2|Baseline|Arm 2|"naltrexone
Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
209277|NCT01342549|B1|Baseline|Arm 1|"sodium valproate
Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
209278|NCT01342549|P2|Participant Flow|Arm 2|"naltrexone
Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
209279|NCT01342549|P1|Participant Flow|Arm 1|"sodium valproate
Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
209280|NCT01342549|O2|Outcome|Arm 2|"naltrexone
Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
209281|NCT01342549|O1|Outcome|Arm 1|"sodium valproate
Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
209282|NCT01342549|E2|Reported Event|Arm 2|"naltrexone
Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
209283|NCT01342549|E1|Reported Event|Arm 1|"sodium valproate
Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
209284|NCT01342523|B33|Baseline|Total|Total of all reporting groups
209285|NCT01342523|B32|Baseline|CIS/Loz/Emails/Full Website/Full Booklet|
209286|NCT01342523|B31|Baseline|CIS/Loz/no Emails/Full Website/Full Booklet|
209287|NCT01342523|B30|Baseline|CIS/no Loz/Emails/Full Website/Full Booklet|
209298|NCT01342523|B19|Baseline|CIS/Loz/no Email/Lite Website/Full Booklet|
209299|NCT01342523|B18|Baseline|CIS/Loz/no Email/Full Website/Brief Booklet|
209300|NCT01342523|B17|Baseline|CIS/Loz/Emails/Lite Website/Brief Booklet|
209301|NCT01342523|B16|Baseline|no CIS/no Loz/no Email/Full Website/Full Booklet|
209302|NCT01342523|B15|Baseline|no CIS/no Loz/Emails/Lite Web/Full Booklet|
209303|NCT01342523|B14|Baseline|no CIS/no Loz/Emails/Full Website/Brief Booklet|
209304|NCT01342523|B13|Baseline|No CIS/Loz/No Emails/Full Website/Lite Booklet|
209305|NCT01342523|B12|Baseline|No CIS/Loz/No Emails/Lite Website/Full Booklet|
209306|NCT01342523|B11|Baseline|No CIS/Loz/Emails/Lite Website/Brief Booklet|
209307|NCT01342523|B10|Baseline|CIS/No Loz/no Email/Lite Website/Full Booklet|
209308|NCT01342523|B9|Baseline|CIS/No Loz/no Email/Full Website/Brief Booklet|
209309|NCT01342523|B8|Baseline|CIS/No Loz/Emails/Lite Website/Brief Booklet|
209310|NCT01342523|B7|Baseline|CIS/Loz/No Email/Lite Website/Brief Booklet|
209311|NCT01342523|B6|Baseline|No CIS/No Loz/No Email/Lite Website/Full Booklet|
209312|NCT01342523|B5|Baseline|No CIS/No Loz/No Email/Full Website/Brief Booklet|
209313|NCT01342523|B4|Baseline|No CIS/no Loz/Email/Lite Website/Brief Booklet|
209314|NCT01342523|B3|Baseline|no CIS/Loz/No Email/Lite Website/Brief Booklet|
209315|NCT01342523|B2|Baseline|CIS/No Loz/No Email/Lite Website/Brief Booklet|
209316|NCT01342523|B1|Baseline|No CIS/No Loz/No Email/Lite Website/Brief Booklet|
209317|NCT01342523|P32|Participant Flow|CIS/Loz/Emails/Full Website/Full Booklet|
209318|NCT01342523|P31|Participant Flow|CIS/Loz/no Emails/Full Website/Full Booklet|
209319|NCT01342523|P30|Participant Flow|CIS/no Loz/Emails/Full Website/Full Booklet|
209320|NCT01342523|P29|Participant Flow|No CIS/Loz/Emails/Full Website/Full Booklet|
209321|NCT01342523|P28|Participant Flow|CIS/Loz/Emails/Lite Website/Full Booklet|
209322|NCT01342523|P27|Participant Flow|CIS/Loz/Emails/Full Website/Brief Booklet|
209323|NCT01342523|P26|Participant Flow|no CIS/no Loz/Emails/Full Website/Full Booklet|
209324|NCT01342523|P25|Participant Flow|No CIS/Loz/no Emails/Full Website/Full Booklet|
209325|NCT01342523|P24|Participant Flow|No CIS/Loz/Emails/Lite Website/Full Booklet|
209326|NCT01342523|P23|Participant Flow|No CIS/Loz/Emails/Full Website/Brief Booklet|
209327|NCT01342523|P22|Participant Flow|CIS/no Loz/no Email/Full Website/Full Booklet|
209328|NCT01342523|P21|Participant Flow|CIS/no Loz/Emails/Lite Website/Full Booklet|
209329|NCT01342523|P20|Participant Flow|CIS/no Loz/Emails/Full Website/Brief Booklet|
209330|NCT01342523|P19|Participant Flow|CIS/Loz/no Email/Lite Website/Full Booklet|
209331|NCT01342523|P18|Participant Flow|CIS/Loz/no Email/Full Website/Brief Booklet|
209332|NCT01342523|P17|Participant Flow|CIS/Loz/Emails/Lite Website/Brief Booklet|
209333|NCT01342523|P16|Participant Flow|no CIS/no Loz/no Email/Full Website/Full Booklet|
209334|NCT01342523|P15|Participant Flow|no CIS/no Loz/Emails/Lite Web/Full Booklet|
209335|NCT01342523|P14|Participant Flow|no CIS/no Loz/Emails/Full Website/Brief Booklet|
209336|NCT01342523|P13|Participant Flow|No CIS/Loz/No Emails/Full Website/Lite Booklet|
209337|NCT01342523|P12|Participant Flow|No CIS/Loz/No Emails/Lite Website/Full Booklet|
209338|NCT01342523|P11|Participant Flow|No CIS/Loz/Emails/Lite Website/Brief Booklet|
209339|NCT01342523|P10|Participant Flow|CIS/No Loz/no Email/Lite Website/Full Booklet|
209340|NCT01342523|P9|Participant Flow|CIS/No Loz/no Email/Full Website/Brief Booklet|
209341|NCT01342523|P8|Participant Flow|CIS/No Loz/Emails/Lite Website/Brief Booklet|
209342|NCT01342523|P7|Participant Flow|CIS/Loz/No Email/Lite Website/Brief Booklet|
209343|NCT01342523|P6|Participant Flow|No CIS/No Loz/No Email/Lite Website/Full Booklet|
209344|NCT01342523|P5|Participant Flow|No CIS/No Loz/No Email/Full Website/Brief Booklet|
209345|NCT01342523|P4|Participant Flow|No CIS/no Loz/Email/Lite Website/Brief Booklet|
209346|NCT01342523|P3|Participant Flow|no CIS/Loz/No Email/Lite Website/Brief Booklet|
209347|NCT01342523|P2|Participant Flow|CIS/No Loz/No Email/Lite Website/Brief Booklet|
209348|NCT01342523|P1|Participant Flow|No CIS/No Loz/No Email/Lite Website/Brief Booklet|
209349|NCT01342523|O10|Outcome|Brief Cessation Booklet|"Participants in the Full Cessation Booklet intervention group received a 12-page booklet developed by the investigators. The content of this booklet was the same as contained in the 36-page Clearing the Air booklet except that information directly relevant to coping skill training (identification of smoking triggers, making coping plans) was removed. Approximately half of the total sample of 1034 participants was randomized to receive the Brief Cessation Booklet; the other half received the Full Cessation Booklet."
209350|NCT01342523|O9|Outcome|Full Cessation Booklet|"Participants in the Full Cessation Booklet intervention group received the National Cancer Institute’s 36-page Clearing the Air brochure (www.smokefree.gov/pubs/clearing_the_air.pdf), containing a detailed guide for preparing to quit, quitting, and preventing relapse as well as suggested resources. Approximately half of the total sample of 1034 participants was randomized to receive the Full Cessation Booklet; the other half received a Brief Cessation Booklet."
209351|NCT01342523|O8|Outcome|Lite SmokeFree.Gov Website|Participants in the Lite SmokeFree.gov Website intervention group received received the “Lite” version of the website (developed by the investigators for this research) that included information about smoking and health such as benefits of quitting and information about withdrawal, medications and stress, but contained no interactive features or content that would support skill training. The look and graphics directly mirrored the full smokefree.gov website, but the number of web pages was reduced from over 50 to 16, and external links to resources were virtually eliminated. Approximately half of the total sample of 1034 participants was randomized to receive theLite SmokeFree.gov Website; the other half received the Full SmokeFree.gov Website.
209382|NCT01342484|P2|Participant Flow|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
209383|NCT01342484|P1|Participant Flow|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
209352|NCT01342523|O7|Outcome|Full SmokeFree.Gov Website|Participants in the Full SmokeFree.gov website intervention group received the standard smokefree.gov website content that included resources to motivate quitting and a step-by-step quitting guide that provided a skill-based intervention for preparing to quit, quitting, and maintaining abstinence. In addition, the active website offered encouragement and support, motivational information, and interactive features and referral links. The active website did not include direct interaction with users (e.g. live help) or interactive audio or video content. User-engagement features included task charts for behavior change, self-monitoring tools (e.g. for cravings and self-assessment), creation of a personal calendar, links to a quitline or to a counselor via text message for live help and social support through social media. No tailoring, feedback or outbound reminders were in use. Approximately half of the total sample of 1034 participants was randomized to receive the Full Smoke
209353|NCT01342523|O6|Outcome|No Email Messaging|Participants in this intervention group received no Email Messaging. Approximately half of the total sample of 1034 participants was randomized to receive no Email Messaging; the other half received 3 months of Email Messaging.
209354|NCT01342523|O5|Outcome|Email Messaging|Participants Email Messaging intervention group received brief email messages that could be accessed by any computer or mobile device that allowed email receipt. Messages were intended to provide: (1) Motivation/encouragement; (2) Quitting tips and information; (3) Adherence/education prompts (to use available resources as recommended), and (4) relapse prevention content. These emailed messages were sent twice/day for two weeks, once/day for an additional month, and then one every 3rd day for an additional 6 weeks (constituting a 3-month-long intervention). Approximately half of the total sample of 1034 participants was randomized to receive Email Messaging; the other half received no Email Messaging.
209355|NCT01342523|O4|Outcome|No Nicotine Replacement Therapy|Participants in this intervention group received no nicotine replacement therapy (NRT), i.e., no nicotine mini-lozenges. Approximately half of the total sample of 1034 participants was randomized to receive no NRT; the other half a 2-week supply of nicotine mini-lozenges.
209356|NCT01342523|O3|Outcome|Nicotine Replacement Therapy (NRT; Mini-Lozenge for 2 Weeks)|Participants in this intervention group received a 2-week starter package of nicotine mini-lozenges, with dose based on time to since first cigarette of the day as per package instructions. Each package contained 2 mini-lozenge dispensers (162 lozenges total) and instructions on proper use. Approximately half of the total sample of 1034 participants was randomized to receive the 2-week supply of mini-lozenges; the other half received no mini-lozenges.
209357|NCT01342523|O2|Outcome|"No Cancer Information Service Counseling (No CIS)"|"Participants in this intervention group did not receive telephone quitline counseling from the Cancer Information Service (CIS). This intervention group will be compared to an intervention group that did receive telephone quitline counseling from the CIS. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (No CIS) and the other half to the CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 581 participants were randomized to No CIS group and 453 to the CIS group."
209358|NCT01342523|O1|Outcome|"Cancer Information Service Counseling (CIS)"|"Participants in this intervention group received telephone quitline counseling from the Cancer Information Service (CIS). These proactive calls initiated by CIS included an initial call (30 min), occurring within 3 days of enrollment, plus 4 additional counseling calls (up to 15 min each) scheduled to occur on the quit day or the day after, and then weekly for the next 3 weeks. The content of the counseling calls focused initially on motivating quitting and then setting a quit date, providing support, building self-efficacy, and skill training. The CIS intervention group will be compared to a No CIS group. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (CIS) and the other half to the No CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 453 participants were randomized to CIS and 581 to the No CIS group."
209359|NCT01342523|E1|Reported Event|Lozenge|2 week supply of nicotine mini-lozenge. This is the only study arm for which adverse events were appropriate to be collected and analyzed, since all other arms did not involve interventions that could generate an adverse event report.
209360|NCT01342510|B5|Baseline|Total|Total of all reporting groups
209361|NCT01342510|B4|Baseline|Control|0.9% saline in a 10 cc syringe
209362|NCT01342510|B3|Baseline|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
209363|NCT01342510|B2|Baseline|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
209364|NCT01342510|B1|Baseline|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
209365|NCT01342510|P4|Participant Flow|Control|0.9% saline in a 10 cc syringe
209366|NCT01342510|P3|Participant Flow|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
209367|NCT01342510|P2|Participant Flow|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
209368|NCT01342510|P1|Participant Flow|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
209369|NCT01342510|O4|Outcome|Control|0.9% saline in a 10 cc syringe
209370|NCT01342510|O3|Outcome|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
209371|NCT01342510|O2|Outcome|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
209372|NCT01342510|O1|Outcome|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
209373|NCT01342510|E4|Reported Event|Control|0.9% saline in a 10 cc syringe
209374|NCT01342510|E3|Reported Event|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
209375|NCT01342510|E2|Reported Event|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
209376|NCT01342510|E1|Reported Event|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
209377|NCT01342484|B4|Baseline|Total|Total of all reporting groups
209378|NCT01342484|B3|Baseline|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
209379|NCT01342484|B2|Baseline|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
209380|NCT01342484|B1|Baseline|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
209381|NCT01342484|P3|Participant Flow|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
209384|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
209385|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
209386|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
209387|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
209388|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
209389|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
209390|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
209391|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
209392|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
209393|NCT01342484|E3|Reported Event|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
209394|NCT01342484|E2|Reported Event|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
209395|NCT01342484|E1|Reported Event|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
209396|NCT01342471|B3|Baseline|Total|Total of all reporting groups
209397|NCT01342471|B2|Baseline|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209398|NCT01342471|B1|Baseline|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209399|NCT01342471|P2|Participant Flow|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209400|NCT01342471|P1|Participant Flow|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209401|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209402|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209403|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209404|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209405|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209406|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209407|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209408|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209409|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209410|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209411|NCT01342471|E2|Reported Event|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209412|NCT01342471|E1|Reported Event|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
209413|NCT01342458|B3|Baseline|Total|Total of all reporting groups
209443|NCT01342445|O2|Outcome|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
209414|NCT01342458|B2|Baseline|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
209415|NCT01342458|B1|Baseline|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
209416|NCT01342458|P2|Participant Flow|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
209417|NCT01342458|P1|Participant Flow|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
209418|NCT01342458|O2|Outcome|Control Group|A rescue analgesic medication (paracetamol) was allowed only if necessary (2g/day max.)
209419|NCT01342458|O1|Outcome|Intervention Group|A rescue analgesic medication (paracetamol) was allowed only if necessary (2g/day max.)
209420|NCT01342458|O2|Outcome|Control Group|Knee adduction moment (KAM) first peak
209421|NCT01342458|O1|Outcome|Intervention Group|Knee adduction moment (KAM) first peak
209422|NCT01342458|O2|Outcome|Control Group|Six-minute walk test
209423|NCT01342458|O1|Outcome|Intervention Group|Six-minute walk test
209424|NCT01342458|O2|Outcome|Control Group|Global score of the Lequesne´s questionaire algo-functional.
209425|NCT01342458|O1|Outcome|Intervention Group|Global score of the Lequesne´s questionaire algo-functional.
209426|NCT01342458|O2|Outcome|Control Group|The WOMAC total score is the sum of all subscale (pain, function and stiffness).
209427|NCT01342458|O1|Outcome|Intervention Group|The WOMAC total score is the sum of all subscale (pain, function and stiffness).
209428|NCT01342458|O2|Outcome|Control Group|WOMAC Physical function subscale
209429|NCT01342458|O1|Outcome|Intervention Group|WOMAC Physical function subscale
209430|NCT01342458|O2|Outcome|Control Group|WOMAC stiffness subscale
209431|NCT01342458|O1|Outcome|Intervention Group|WOMAC stiffness subscale
209432|NCT01342458|O2|Outcome|Control Group|WOMAC pain subscale
209433|NCT01342458|O1|Outcome|Intervention Group|WOMAC pain subscale
209434|NCT01342458|E2|Reported Event|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
209435|NCT01342458|E1|Reported Event|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
209436|NCT01342445|B3|Baseline|Total|Total of all reporting groups
209437|NCT01342445|B2|Baseline|Healthy Controls|All participants completed the Conners' Adult ADHD Rating Scales–Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning–Adult Version (BRIEF) at baseline only and received no drug.
209438|NCT01342445|B1|Baseline|ADHD Participants|All participants completed the Conners' Adult ADHD Rating Scales–Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning–Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg LDX in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition.
209439|NCT01342445|P2|Participant Flow|Attention-deficit/Hyperactivity Disorder (ADHD) Participants|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg lisdexamfetamine dimesylate (LDX) in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition. Each phase was conducted for 1 week, and therefore, the total trial took place over 5 weeks and was able to be completed during a single semester. Participants ingested one pill per day on awakening.
209440|NCT01342445|P1|Participant Flow|Healthy Controls|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline only and received no drug.
209441|NCT01342445|O4|Outcome|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
209442|NCT01342445|O3|Outcome|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
209444|NCT01342445|O1|Outcome|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
209445|NCT01342445|O4|Outcome|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
209446|NCT01342445|O3|Outcome|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
209447|NCT01342445|O2|Outcome|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
209448|NCT01342445|O1|Outcome|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
209449|NCT01342445|E4|Reported Event|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
209450|NCT01342445|E3|Reported Event|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
209451|NCT01342445|E2|Reported Event|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
209452|NCT01342445|E1|Reported Event|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
209453|NCT01342341|B3|Baseline|Total|Total of all reporting groups
209454|NCT01342341|B2|Baseline|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.
NOTE: This is a cross-over design and subjects will participate in both arms.
Parafon Forte: Drug: Parafon Forte administered at study visit
Other: Placebo administered at study visit"
209455|NCT01342341|B1|Baseline|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.
Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.
Parafon Forte: Drug: Parafon Forte administered at study visit
Other: Placebo administered at study visit"
209456|NCT01342341|P2|Participant Flow|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.
NOTE: This is a cross-over design and subjects will participate in both arms.
Parafon Forte: Drug: Parafon Forte administered at study visit
Other: Placebo administered at study visit"
209457|NCT01342341|P1|Participant Flow|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.
Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.
Parafon Forte: Drug: Parafon Forte administered at study visit
Other: Placebo administered at study visit"
209458|NCT01342341|O2|Outcome|Placebo|"Group B Experimental: Twenty moderate to heavy social alcohol users as described above will receive placebo x 14 days.
NOTE: This is a cross-over design and subjects will participate in both arms.
Parafon Forte: Drug: Parafon Forte administered at study visit
Other: Placebo administered at study visit"
209459|NCT01342341|O1|Outcome|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.
Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.
Parafon Forte: Drug: Parafon Forte administered at study visit
Other: Placebo administered at study visit"
209460|NCT01342341|E2|Reported Event|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.
NOTE: This is a cross-over design and subjects will participate in both arms.
Parafon Forte: Drug: Parafon Forte administered at study visit
Other: Placebo administered at study visit"
209461|NCT01342341|E1|Reported Event|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.
Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.
Parafon Forte: Drug: Parafon Forte administered at study visit
Other: Placebo administered at study visit"
209462|NCT01342172|B1|Baseline|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
209463|NCT01342172|P1|Participant Flow|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
209464|NCT01342172|O1|Outcome|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
209465|NCT01342172|E1|Reported Event|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
209466|NCT01342107|B3|Baseline|Total|Total of all reporting groups
209467|NCT01342107|B2|Baseline|Blister Pack|Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.
209468|NCT01342107|B1|Baseline|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.
209469|NCT01342107|P2|Participant Flow|Blister Pack|Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.
209470|NCT01342107|P1|Participant Flow|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.
209471|NCT01342107|O2|Outcome|Blister Pack|Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear.
209472|NCT01342107|O1|Outcome|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear.
209473|NCT01342107|E2|Reported Event|Blister Pack|Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear.
209515|NCT01341977|E2|Reported Event|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
209474|NCT01342107|E1|Reported Event|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear.
209475|NCT01342094|B3|Baseline|Total|Total of all reporting groups
209476|NCT01342094|B2|Baseline|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
209477|NCT01342094|B1|Baseline|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209478|NCT01342094|P2|Participant Flow|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
209479|NCT01342094|P1|Participant Flow|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209480|NCT01342094|O2|Outcome|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
209481|NCT01342094|O1|Outcome|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209482|NCT01342094|E2|Reported Event|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
209483|NCT01342094|E1|Reported Event|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209484|NCT01342081|B4|Baseline|Total|Total of all reporting groups
209485|NCT01342081|B3|Baseline|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
209486|NCT01342081|B2|Baseline|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209487|NCT01342081|B1|Baseline|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209488|NCT01342081|P3|Participant Flow|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
209489|NCT01342081|P2|Participant Flow|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209490|NCT01342081|P1|Participant Flow|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209491|NCT01342081|O3|Outcome|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
209492|NCT01342081|O2|Outcome|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209493|NCT01342081|O1|Outcome|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209494|NCT01342081|E3|Reported Event|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
209495|NCT01342081|E2|Reported Event|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209496|NCT01342081|E1|Reported Event|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
209497|NCT01341990|B3|Baseline|Total|Total of all reporting groups
209498|NCT01341990|B2|Baseline|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
209499|NCT01341990|B1|Baseline|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
209500|NCT01341990|P2|Participant Flow|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
209501|NCT01341990|P1|Participant Flow|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
209502|NCT01341990|O2|Outcome|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
209503|NCT01341990|O1|Outcome|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
209504|NCT01341990|O2|Outcome|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
209505|NCT01341990|O1|Outcome|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
209506|NCT01341990|E2|Reported Event|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
209507|NCT01341990|E1|Reported Event|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
209508|NCT01341977|B3|Baseline|Total|Total of all reporting groups
209509|NCT01341977|B2|Baseline|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
209510|NCT01341977|B1|Baseline|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
209511|NCT01341977|P2|Participant Flow|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
209512|NCT01341977|P1|Participant Flow|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
209513|NCT01341977|O2|Outcome|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
209514|NCT01341977|O1|Outcome|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
209516|NCT01341977|E1|Reported Event|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
209517|NCT01341912|B1|Baseline|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.
Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
209518|NCT01341912|P1|Participant Flow|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.
Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
209519|NCT01341912|O1|Outcome|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.
Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
209520|NCT01341912|O1|Outcome|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.
Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
209521|NCT01341912|E1|Reported Event|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.
Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
209522|NCT01341782|B3|Baseline|Total|Total of all reporting groups
209523|NCT01341782|B2|Baseline|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
209524|NCT01341782|B1|Baseline|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
209525|NCT01341782|P2|Participant Flow|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (intact parathyroid hormone [iPTH] < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
209526|NCT01341782|P1|Participant Flow|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
209527|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
209528|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
209529|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
209530|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
209531|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
209532|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
209533|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
209534|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
209535|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
209536|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
209537|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
209538|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
209539|NCT01341782|E2|Reported Event|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
209540|NCT01341782|E1|Reported Event|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
209541|NCT01341600|B4|Baseline|Total|Total of all reporting groups
209542|NCT01341600|B3|Baseline|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209543|NCT01341600|B2|Baseline|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209544|NCT01341600|B1|Baseline|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209545|NCT01341600|P3|Participant Flow|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI (NCT00799396)) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209546|NCT01341600|P2|Participant Flow|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI (NCT00799396)) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209547|NCT01341600|P1|Participant Flow|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI (NCT00799396)) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209548|NCT01341600|O3|Outcome|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209549|NCT01341600|O2|Outcome|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209550|NCT01341600|O1|Outcome|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209551|NCT01341600|O3|Outcome|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209552|NCT01341600|O2|Outcome|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209553|NCT01341600|O1|Outcome|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209554|NCT01341600|O3|Outcome|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209555|NCT01341600|O2|Outcome|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209556|NCT01341600|O1|Outcome|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209557|NCT01341600|O3|Outcome|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209558|NCT01341600|O2|Outcome|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209559|NCT01341600|O1|Outcome|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209560|NCT01341600|E3|Reported Event|Extensive Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 extensive metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209593|NCT01340937|P4|Participant Flow|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209594|NCT01340937|P3|Participant Flow|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209561|NCT01341600|E2|Reported Event|Intermediate Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 intermediate metabolizers to clopidogrel 75 mg in PAPI (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209562|NCT01341600|E1|Reported Event|Poor Metabolizers|"Healthy subjects who have been genotyped for CYP2C19*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers to clopidogrel 75 mg from participants who previously received clopidogrel as part of another NIH sponsored clinical trial entitled, Pharmacogenetics of Anti-platelet Intervention (PAPI) Study (NCT 00799396).
Clopidogrel, Omeprazole: Over a 6 week period participants will be given:
75mg of clopidogrel for 8 days, at least 1 week washout, 150mg of clopidogrel for eight days, at least 1 week washout, 300mg of clopidogrel for eight days. Participants will have the option to participate in a final week in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days."
209563|NCT01341444|B3|Baseline|Total|Total of all reporting groups
209564|NCT01341444|B2|Baseline|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier
Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
209565|NCT01341444|B1|Baseline|Prevena Incision Management System|"Negative Pressure Therapy Device
Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
209566|NCT01341444|P2|Participant Flow|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier
Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
209567|NCT01341444|P1|Participant Flow|Prevena Incision Management System|"Negative Pressure Therapy Device
Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
209568|NCT01341444|O2|Outcome|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier
Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
209569|NCT01341444|O1|Outcome|Prevena Incision Management System|"Negative Pressure Therapy Device
Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
209570|NCT01341444|E2|Reported Event|Standard of Care for Surgical Incisions|"Sterile gauze and a non-penetrable barrier
Standard of Care for Surgical Incisions: Sterile 4X4 Non-Penetrable barrier"
209571|NCT01341444|E1|Reported Event|Prevena Incision Management System|"Negative Pressure Therapy Device
Prevena Incision Management System: It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT)."
209572|NCT01340144|B3|Baseline|Total|Total of all reporting groups
209573|NCT01340144|B2|Baseline|PFC Sigma HP PS TKA (Total Knee Arthoplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
209574|NCT01340144|B1|Baseline|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
209575|NCT01340144|P2|Participant Flow|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
209576|NCT01340144|P1|Participant Flow|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
209577|NCT01340144|O2|Outcome|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
209578|NCT01340144|O1|Outcome|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
209579|NCT01340144|E2|Reported Event|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
209580|NCT01340144|E1|Reported Event|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
209581|NCT01341067|B1|Baseline|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
209582|NCT01341067|P1|Participant Flow|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
209583|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
209584|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
209585|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
209586|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
209587|NCT01341067|E1|Reported Event|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
209588|NCT01340937|B5|Baseline|Total|Total of all reporting groups
209589|NCT01340937|B4|Baseline|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209590|NCT01340937|B3|Baseline|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209591|NCT01340937|B2|Baseline|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209592|NCT01340937|B1|Baseline|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209595|NCT01340937|P2|Participant Flow|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209596|NCT01340937|P1|Participant Flow|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209597|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209598|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209599|NCT01340937|O2|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209600|NCT01340937|O1|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209601|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209602|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209603|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209604|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209605|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209606|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209607|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209608|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209609|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209610|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209611|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209612|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209613|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209614|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209615|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209616|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209617|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209618|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209619|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209777|NCT01340768|O1|Outcome|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
209620|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209621|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209622|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209623|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209624|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209625|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209626|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209627|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209628|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209629|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209630|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209631|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209632|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209633|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209634|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209635|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209636|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209637|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209638|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209639|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209640|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209641|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209642|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209643|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209644|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209847|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209645|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209646|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209647|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209648|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209649|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209650|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209651|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209652|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209653|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209654|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209655|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209656|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209657|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209658|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209659|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209660|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209661|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209662|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209663|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209664|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209665|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209666|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209667|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209668|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209669|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209848|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
209670|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209671|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209672|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209673|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209674|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209675|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209676|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209677|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209678|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209679|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209680|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209681|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209682|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209683|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209684|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209685|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209686|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209687|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209688|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209689|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209690|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209691|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209692|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209693|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209694|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209932|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209695|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209696|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209697|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209698|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209699|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209700|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209701|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209702|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209703|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209704|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209705|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209706|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209707|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209708|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209709|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209710|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209711|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209712|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209713|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209714|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209715|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209716|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209717|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209718|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209719|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209849|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209720|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209721|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209722|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209723|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209724|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209725|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209726|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209727|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209728|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209729|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209730|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209731|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209732|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209733|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209734|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209735|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209736|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209737|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209738|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209739|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209740|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209741|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209742|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209743|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209744|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209850|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209745|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209746|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209747|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209748|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209749|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209750|NCT01340937|E2|Reported Event|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
209751|NCT01340937|E1|Reported Event|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
209752|NCT01340794|B3|Baseline|Total|Total of all reporting groups
209753|NCT01340794|B2|Baseline|Treatment: Pazopanib With Run-in|"Cycle 1:
Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 2:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 3 and beyond:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
209754|NCT01340794|B1|Baseline|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
209755|NCT01340794|P2|Participant Flow|Treatment: Pazopanib Run-in|"Cycle 1:
Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 2:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 3 and beyond:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
209756|NCT01340794|P1|Participant Flow|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
209757|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:
Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 2:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 3 and beyond:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
209758|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
209759|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:
Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 2:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 3 and beyond:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
209760|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
209761|NCT01340794|O2|Outcome|Treatment: Pazopanib With Run-in|"Cycle 1:
Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 2:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 3 and beyond:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
209762|NCT01340794|O1|Outcome|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
209763|NCT01340794|O2|Outcome|Treatment: Pazopanib With Run-in|"Cycle 1:
Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 2:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 3 and beyond:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
209764|NCT01340794|O1|Outcome|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
209765|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:
Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 2:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 3 and beyond:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
209766|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
209767|NCT01340794|E2|Reported Event|Treatment: Pazopanib With Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
209768|NCT01340794|E1|Reported Event|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
209769|NCT01340768|B3|Baseline|Total|Total of all reporting groups
209770|NCT01340768|B2|Baseline|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
209771|NCT01340768|B1|Baseline|Sitagliptin|Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
209772|NCT01340768|P2|Participant Flow|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
209773|NCT01340768|P1|Participant Flow|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
209774|NCT01340768|O2|Outcome|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
209775|NCT01340768|O1|Outcome|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
209776|NCT01340768|O2|Outcome|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
209778|NCT01340768|E2|Reported Event|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
209779|NCT01340768|E1|Reported Event|Sitagliptin|Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
209780|NCT01340664|B4|Baseline|Total|Total of all reporting groups
209781|NCT01340664|B3|Baseline|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks.
209782|NCT01340664|B2|Baseline|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
209783|NCT01340664|B1|Baseline|Placebo|Each patient received matching placebo twice daily for 18 weeks.
209784|NCT01340664|P3|Participant Flow|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks.
209785|NCT01340664|P2|Participant Flow|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
209786|NCT01340664|P1|Participant Flow|Placebo|Each patient received matching placebo twice daily for 18 weeks.
209787|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
209788|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
209789|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
209790|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
209791|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
209792|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
209793|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
209794|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
209795|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
209796|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
209797|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
209798|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
209799|NCT01340664|E3|Reported Event|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
209800|NCT01340664|E2|Reported Event|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
209801|NCT01340664|E1|Reported Event|Placebo|Each patient received matching placebo twice daily for 18 weeks
209802|NCT01340651|B1|Baseline|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
209803|NCT01340651|P1|Participant Flow|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD. At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
209804|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
209805|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
209806|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
209807|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
209808|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
209809|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
209810|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
209811|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
209812|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
209813|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
209814|NCT01340651|E2|Reported Event|Ruxolitinib - After Week 16|At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
209851|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
209815|NCT01340651|E1|Reported Event|Ruxolitinib - Weeks 1-16|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
209816|NCT01340625|B3|Baseline|Total|Total of all reporting groups
209817|NCT01340625|B2|Baseline|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
209818|NCT01340625|B1|Baseline|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
209819|NCT01340625|P2|Participant Flow|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
209820|NCT01340625|P1|Participant Flow|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
209821|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
209822|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
209823|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
209824|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
209825|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
209826|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
209827|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
209828|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
209829|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
209830|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
209831|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
209832|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
209833|NCT01340625|E2|Reported Event|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
209834|NCT01340625|E1|Reported Event|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
209835|NCT01340586|B3|Baseline|Total|Total of all reporting groups
209836|NCT01340586|B2|Baseline|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209837|NCT01340586|B1|Baseline|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209838|NCT01340586|P2|Participant Flow|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209839|NCT01340586|P1|Participant Flow|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209840|NCT01340586|O2|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209841|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209842|NCT01340586|O2|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209843|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209844|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209845|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
209846|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
210600|NCT01339260|B3|Baseline|Total|Total of all reporting groups
209852|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209853|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209854|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
209855|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209856|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209857|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209858|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209859|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209860|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209861|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
209862|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209863|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209864|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
209865|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209866|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209867|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209868|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
209869|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209870|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209871|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209872|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209873|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
209874|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209875|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209876|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
209877|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209878|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
209879|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209880|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
209881|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209882|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209883|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
209884|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209885|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209886|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
209887|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209888|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209889|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
209890|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209891|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209892|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
209893|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209894|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209895|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
209896|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209897|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209898|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
209899|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209900|NCT01340586|E3|Reported Event|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
209901|NCT01340586|E2|Reported Event|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
209902|NCT01340586|E1|Reported Event|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
209903|NCT01340573|B1|Baseline|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
209904|NCT01340573|P1|Participant Flow|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
209905|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
209906|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
209907|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
209908|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
209909|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
209910|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
209911|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
209912|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
209913|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
209914|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
209915|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
209916|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
209917|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
209918|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
209919|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
209920|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
209921|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
209922|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
209923|NCT01340573|E1|Reported Event|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
209924|NCT01340209|B4|Baseline|Total|Total of all reporting groups
209925|NCT01340209|B3|Baseline|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209926|NCT01340209|B2|Baseline|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209927|NCT01340209|B1|Baseline|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209928|NCT01340209|P3|Participant Flow|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209929|NCT01340209|P2|Participant Flow|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209930|NCT01340209|P1|Participant Flow|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209931|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209933|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209934|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209935|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209936|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209937|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209938|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209939|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209940|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209941|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209942|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209943|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209944|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209945|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209946|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209947|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209948|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209949|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209950|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209951|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209952|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209953|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209954|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209955|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209956|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209957|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209958|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209959|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209960|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209961|NCT01340209|E3|Reported Event|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
209962|NCT01340209|E2|Reported Event|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
209963|NCT01340209|E1|Reported Event|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
209964|NCT01340196|B1|Baseline|All Participants|tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
209965|NCT01340196|P1|Participant Flow|All Participants|tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
209966|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
209967|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
209968|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
209969|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
209970|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
209971|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
209972|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
209973|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
209974|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
209975|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
209976|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
209977|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
211405|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
209978|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
209979|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
209980|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
209981|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
209982|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
209983|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7
209984|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
209985|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
209986|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7
209987|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
209988|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
209989|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
209990|NCT01340196|E3|Reported Event|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
209991|NCT01340196|E2|Reported Event|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
209992|NCT01340196|E1|Reported Event|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
209993|NCT01340066|B3|Baseline|Total|Total of all reporting groups
209994|NCT01340066|B2|Baseline|UISH001|At randomization at visit 2, subjects were treated with UISH001.
209995|NCT01340066|B1|Baseline|Matching Placebo|At randomization at visit 2, subjects were treated with matching placebo.
209996|NCT01340066|P3|Participant Flow|UISH001|Subjects were randomized at Visit 2
209997|NCT01340066|P2|Participant Flow|Placebo|Subjects were randomized at Visit 2
209998|NCT01340066|P1|Participant Flow|Placebo Run-In|All subjects entered a one week placebo run in period to qualify for the study.
209999|NCT01340066|O2|Outcome|UISH001|1 drop UISH001 sublingual 3 times/day
210000|NCT01340066|O1|Outcome|Placebo|1 drop Placebo sublingual 3 times/day
210001|NCT01340066|E3|Reported Event|Matching Placebo|Subjects were treated with matching placebo during double blind treatment period.
210002|NCT01340066|E2|Reported Event|UISH001|Subjects were treated with UISH001 during double blind treatment period.
210003|NCT01340066|E1|Reported Event|Non-Randomized Subjects|Adverse Events (AEs) captured for subjects that were not randomized
210004|NCT01340027|B13|Baseline|Total|Total of all reporting groups
210005|NCT01340027|B12|Baseline|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210006|NCT01340027|B11|Baseline|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210007|NCT01340027|B10|Baseline|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210008|NCT01340027|B9|Baseline|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210009|NCT01340027|B8|Baseline|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210010|NCT01340027|B7|Baseline|Solifenacin 2.5 mg +Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210011|NCT01340027|B6|Baseline|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210012|NCT01340027|B5|Baseline|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210013|NCT01340027|B4|Baseline|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210014|NCT01340027|B3|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210015|NCT01340027|B2|Baseline|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210016|NCT01340027|B1|Baseline|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210017|NCT01340027|P12|Participant Flow|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210018|NCT01340027|P11|Participant Flow|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210019|NCT01340027|P10|Participant Flow|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210020|NCT01340027|P9|Participant Flow|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210021|NCT01340027|P8|Participant Flow|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210022|NCT01340027|P7|Participant Flow|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210023|NCT01340027|P6|Participant Flow|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210024|NCT01340027|P5|Participant Flow|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210025|NCT01340027|P4|Participant Flow|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210026|NCT01340027|P3|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210027|NCT01340027|P2|Participant Flow|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210028|NCT01340027|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210029|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210030|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210031|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210032|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210033|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210034|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210035|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210036|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210037|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210038|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210039|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210040|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210041|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210042|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210043|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210044|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210045|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210046|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210047|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210048|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210049|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210050|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210051|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210052|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210053|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210054|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210055|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210056|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210057|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210058|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210059|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210060|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210061|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210062|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210063|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210064|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210065|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210066|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210067|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210068|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210069|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210070|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210071|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210072|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210073|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210074|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210075|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210076|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210077|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210078|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210079|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210080|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210081|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210082|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210083|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210084|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210085|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210086|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210087|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210088|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210089|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210090|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210091|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210092|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210093|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210094|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210095|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210096|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210097|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210098|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210099|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210100|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210101|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210102|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210103|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210104|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210105|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210106|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210107|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210108|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210109|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210110|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210111|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210112|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210113|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210114|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210115|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210116|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
211406|NCT01335750|O2|Outcome|Multipurpose Solution #2|B&L Renu Fresh Multipurpose Solution
210117|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210118|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210119|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210120|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210121|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210122|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210123|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210124|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210125|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210126|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210127|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210128|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210129|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210130|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210131|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210132|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210133|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210134|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210135|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210136|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210137|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210138|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210139|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210140|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210141|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210142|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210143|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210144|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210145|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210146|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210147|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210148|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210149|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210150|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210151|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210152|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210153|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210154|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210155|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210156|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210157|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210158|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210159|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210160|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210161|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210162|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
211407|NCT01335750|O1|Outcome|Multipurpose Solution #1|Optifree Replenish
210163|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210164|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210165|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210166|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210167|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210168|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210169|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210170|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210171|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210172|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210173|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210174|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210175|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210176|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210177|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210178|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210179|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210180|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210181|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210182|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210183|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210184|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210185|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210186|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210187|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210188|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210189|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210190|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210191|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210192|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210193|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210194|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210195|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210196|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210197|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210198|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210199|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210200|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210201|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210202|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210203|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210204|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210205|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210206|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210207|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210208|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
211408|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline solution
210209|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210210|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210211|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210212|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210213|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210214|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210215|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210216|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210217|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210218|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210219|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210220|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210221|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210222|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210223|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210224|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210225|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210226|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210227|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210228|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210229|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210230|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210231|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210232|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210233|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210234|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210235|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210236|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210237|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210238|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210239|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210240|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210241|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210242|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210243|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210244|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210245|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210246|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210247|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210248|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210249|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210250|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210251|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210252|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210253|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210254|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210255|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210256|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210257|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210258|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210259|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210260|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210261|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210262|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210263|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210264|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210265|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210266|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210267|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210268|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210269|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210270|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210271|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210272|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210273|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210274|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210275|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210276|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210277|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210278|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210279|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210280|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210281|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210282|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210283|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210284|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210285|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210286|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210287|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210288|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210289|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210290|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210291|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210292|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210293|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210294|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210295|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210296|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210297|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210298|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210299|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210300|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210301|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210302|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210303|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210304|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210305|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210306|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210307|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210308|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210309|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210310|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210311|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210312|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210313|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210314|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210315|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210316|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210317|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210318|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210319|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210320|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210321|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210322|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210323|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210324|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210325|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210326|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210327|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210328|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210329|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210330|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210331|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210332|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210333|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210334|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210335|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210336|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210337|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210338|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210339|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210340|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210341|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210342|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210343|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210344|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210345|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210346|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210347|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210348|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210349|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210350|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210351|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210352|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210353|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210354|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210355|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210356|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210357|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210358|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210359|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210360|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210361|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210362|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210363|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210364|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210365|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210366|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210367|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210368|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210369|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210370|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210371|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210372|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210373|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210374|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210375|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210376|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210377|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210378|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210379|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210380|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210381|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210382|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210383|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210384|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210385|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210386|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210387|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210388|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210389|NCT01340027|E12|Reported Event|Solifenacin 10 mg and Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210390|NCT01340027|E11|Reported Event|Solifenacin 10 mg and Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210391|NCT01340027|E10|Reported Event|Solifenacin 5 mg and Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210392|NCT01340027|E9|Reported Event|Solifenacin 5 mg and Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210393|NCT01340027|E8|Reported Event|Solifenacin 2.5 mg and Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
210394|NCT01340027|E7|Reported Event|Solifenacin 2.5 mg and Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
210395|NCT01340027|E6|Reported Event|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
210396|NCT01340027|E5|Reported Event|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
210397|NCT01340027|E4|Reported Event|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
210398|NCT01340027|E3|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
210399|NCT01340027|E2|Reported Event|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
210400|NCT01340027|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
210401|NCT01340014|B3|Baseline|Total|Total of all reporting groups
210402|NCT01340014|B2|Baseline|COSOPT/AZARGA|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
210403|NCT01340014|B1|Baseline|AZARGA/COSOPT|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
210404|NCT01340014|P2|Participant Flow|COSOPT/AZARGA|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
210405|NCT01340014|P1|Participant Flow|AZARGA/COSOPT|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
210406|NCT01340014|O2|Outcome|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
210407|NCT01340014|O1|Outcome|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
210408|NCT01340014|O2|Outcome|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
210409|NCT01340014|O1|Outcome|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
210410|NCT01340014|E2|Reported Event|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
210411|NCT01340014|E1|Reported Event|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
210412|NCT01339936|B1|Baseline|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
210413|NCT01339936|P1|Participant Flow|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
210414|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
210415|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
210416|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
210417|NCT01339936|E1|Reported Event|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
210418|NCT01339923|B8|Baseline|TOTAL|Total of all reporting groups
210419|NCT01339923|B7|Baseline|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
210420|NCT01339923|B6|Baseline|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
210421|NCT01339923|B5|Baseline|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
210422|NCT01339923|B4|Baseline|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
210423|NCT01339923|B3|Baseline|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
210424|NCT01339923|B2|Baseline|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
210425|NCT01339923|B1|Baseline|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
210426|NCT01339923|P7|Participant Flow|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
210427|NCT01339923|P6|Participant Flow|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
210428|NCT01339923|P5|Participant Flow|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
210429|NCT01339923|P4|Participant Flow|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
211409|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
210430|NCT01339923|P3|Participant Flow|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
210431|NCT01339923|P2|Participant Flow|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
210432|NCT01339923|P1|Participant Flow|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
210433|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
210434|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
210435|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
rMenB + OMV NZ vaccine: 2 doses 2 months apart"
210436|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
rMenB + OMV NZ vaccine: 2 doses 2 months apart"
210437|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
210438|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
210439|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
210440|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
210441|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
210442|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
210443|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
210444|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
rMenB + OMV NZ vaccine: 2 doses 2 months apart"
210445|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
rMenB + OMV NZ vaccine: 2 doses 2 months apart"
210446|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
rMenB + OMV NZ vaccine: 2 doses 2 months apart"
210447|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
rMenB + OMV NZ vaccine: 2 doses 2 months apart"
210448|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
210449|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
210450|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
210451|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
210452|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
210453|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
210454|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
210455|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
210456|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
210457|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
210458|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 ad 15 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
210459|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 3, 5 12 rMenB + OMV vaccine"
210460|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
210461|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
210462|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
210463|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
210464|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
rMenB + OMV NZ vaccine: 2 doses 2 months apart"
210465|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
210466|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
210467|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
210468|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
210469|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
210470|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
210471|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
210472|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
210473|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
210474|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
210475|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
210476|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
210477|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
210478|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
210479|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
210480|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
210481|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
210482|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
210483|NCT01339923|O4|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
rMenB + OMV NZ vaccine: 2 doses 2 months apart"
210484|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
210485|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
210486|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
210487|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
rMenB + OMV NZ vaccine: 2 doses 2 months apart"
210488|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
rMenB + OMV NZ vaccine: 2 doses 2 months apart"
210489|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months of age) plus booster (11 months of age)"
210490|NCT01339923|O2|Outcome|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
211345|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
210491|NCT01339923|O1|Outcome|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
210492|NCT01339923|E8|Reported Event|TOTAL|All subjects in the safety population.
210493|NCT01339923|E7|Reported Event|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
210494|NCT01339923|E6|Reported Event|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
210495|NCT01339923|E5|Reported Event|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
210496|NCT01339923|E4|Reported Event|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
210497|NCT01339923|E3|Reported Event|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
210498|NCT01339923|E2|Reported Event|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
210499|NCT01339923|E1|Reported Event|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
210500|NCT01339897|B5|Baseline|Total|Total of all reporting groups
210501|NCT01339897|B4|Baseline|Placebo|Non-Active
210502|NCT01339897|B3|Baseline|Cohort 3|N6022 - Active 20 mg
210503|NCT01339897|B2|Baseline|Cohort 2|N6022 - Active 10 mg
210504|NCT01339897|B1|Baseline|Cohort 1|N6022 - Active 5 mg
210505|NCT01339897|P4|Participant Flow|20 mg/N6022|Active Group- 20 mg by IV administration (5 mg/minute)
210506|NCT01339897|P3|Participant Flow|10 mg/N6022|Active Group- 10 mg by IV administration (5 mg/minute)
210507|NCT01339897|P2|Participant Flow|Placebo|Non-Active
210508|NCT01339897|P1|Participant Flow|5 mg/N6022|Active Group- 5 mg by IV administration (5 mg/minute)
210509|NCT01339897|O4|Outcome|Placebo|Non-Active
210510|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
210511|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
210512|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
210513|NCT01339897|O4|Outcome|Placebo|Non-Active
210514|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
210515|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
210516|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
210517|NCT01339897|O4|Outcome|Placebo|Non-Active
210518|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
210519|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
210520|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
210521|NCT01339897|O4|Outcome|Placebo|Non-Active
210522|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
210523|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
210524|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
210525|NCT01339897|O4|Outcome|Placebo|Non-Active
210526|NCT01339897|O3|Outcome|Cohort 3|N6022 - Active 20 mg
210527|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
210528|NCT01339897|O1|Outcome|Cohort 1|N6022 - Active 5 mg
210529|NCT01339897|E4|Reported Event|Placebo|Non-Active
210530|NCT01339897|E3|Reported Event|Cohort 3|N6022 - Active 20 mg
210531|NCT01339897|E2|Reported Event|Cohort 2|N6022 Active - 10 mg
210532|NCT01339897|E1|Reported Event|Cohort 1|N6022 - Active 5 mg
210533|NCT01339832|B1|Baseline|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
210534|NCT01339832|P1|Participant Flow|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
210535|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
210536|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
210537|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
210538|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
210539|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
210540|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
210541|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
210542|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
211346|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
210543|NCT01339832|E1|Reported Event|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
210544|NCT01339429|B1|Baseline|Simplified Negative Pressure Wound Therapy|"The simplified Negative Pressure device will be placed on subjects selected from the hospital wards and meeting the eligibility criteria.
simplified Negative Pressure device: A non-powered negative pressure device utilizing a bellows which is compressed every eight hours."
210545|NCT01339429|P1|Participant Flow|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device was placed on subjects selected from hospital wards and meeting the eligibility criteria regarding wound size and condition. Inclusion criteria included age 14 years or older, adequate adjacent intact skin and wound location for application of the sNPWT dressing, adequate pain control, and anticipated clinically stability and hospitalization for the duration of the study. Exclusion criteria were exposed blood vessels, evidence of ischemia, necrotic tissue requiring further debridement, infection, osteomyelitis, and malignancy in the wound.
Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing via a drainage tube."
210546|NCT01339429|O1|Outcome|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria regarding wound size and condition.
Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
210547|NCT01339429|O1|Outcome|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria regarding wound size and condition.
Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
210548|NCT01339429|E1|Reported Event|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device was placed on subjects selected from the hospital wards and meeting the eligibility criteria regarding wound size and condition.
Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
210549|NCT01339416|B1|Baseline|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
210550|NCT01339416|P1|Participant Flow|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
210551|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
210552|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
210553|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
210554|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
210555|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
210556|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
210557|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
210558|NCT01339416|E1|Reported Event|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
210559|NCT01339403|B3|Baseline|Total|Total of all reporting groups
210560|NCT01339403|B2|Baseline|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210561|NCT01339403|B1|Baseline|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210562|NCT01339403|P2|Participant Flow|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210563|NCT01339403|P1|Participant Flow|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210564|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210565|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210566|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210567|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210568|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210569|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210570|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210571|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210572|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210573|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210574|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210575|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210576|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210577|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210578|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210579|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210580|NCT01339403|E2|Reported Event|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210581|NCT01339403|E1|Reported Event|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
210582|NCT01339390|B3|Baseline|Total|Total of all reporting groups
210583|NCT01339390|B2|Baseline|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.
MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
210584|NCT01339390|B1|Baseline|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.
MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
210585|NCT01339390|P2|Participant Flow|Arm 2: MOVE!|"As part of routine care, all patients who are eligible for the present study are identified by a clinical reminder. This prompts the primary care provider (PCP) to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.
MOVE!: As part of routine care, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
210601|NCT01339260|B2|Baseline|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle
Palonosetron
Dexamethasone"
210602|NCT01339260|B1|Baseline|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle
Netupitant and Palonosetron
Dexamethasone"
210603|NCT01339260|P2|Participant Flow|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle
Palonosetron
Dexamethasone"
210586|NCT01339390|P1|Participant Flow|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE! program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.
MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
210587|NCT01339390|O2|Outcome|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.
MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
210588|NCT01339390|O1|Outcome|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.
MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
210589|NCT01339390|E2|Reported Event|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.
MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
210590|NCT01339390|E1|Reported Event|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.
MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
210591|NCT01339299|B3|Baseline|Total|Total of all reporting groups
210592|NCT01339299|B2|Baseline|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)
recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
210593|NCT01339299|B1|Baseline|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )
recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
210594|NCT01339299|P2|Participant Flow|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)
recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
210595|NCT01339299|P1|Participant Flow|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )
recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
210596|NCT01339299|O2|Outcome|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)
recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
210597|NCT01339299|O1|Outcome|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )
recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
210598|NCT01339299|E2|Reported Event|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)
recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
210599|NCT01339299|E1|Reported Event|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )
recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
210604|NCT01339260|P1|Participant Flow|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle
Netupitant and Palonosetron
Dexamethasone"
210605|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle
Palonosetron
Dexamethasone"
210606|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle
Netupitant and Palonosetron
Dexamethasone"
210607|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle
Palonosetron
Dexamethasone"
210608|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle
Netupitant and Palonosetron
Dexamethasone"
210609|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle
Palonosetron
Dexamethasone"
210610|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle
Netupitant and Palonosetron
Dexamethasone"
210611|NCT01339260|E4|Reported Event|Palonosetron+Dexamethasone-multicycle Extension|Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
210612|NCT01339260|E3|Reported Event|Netupitant and Palonosetron+Dexamethasone-multicycle Extension|Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
210613|NCT01339260|E2|Reported Event|Palonosetron+Dexamethasone-cycle 1|Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
210614|NCT01339260|E1|Reported Event|Netupitant and Palonosetron+Dexamethasone-cycle 1|Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
210615|NCT01339247|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga – Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in Period 1 and test product in Period 2
210616|NCT01339247|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1; followed by test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2
210617|NCT01339247|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
210618|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
210619|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
210620|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
210621|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
210622|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
210623|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
210624|NCT01339247|E2|Reported Event|Period 2|Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
210625|NCT01339247|E1|Reported Event|Period 1|Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1
210626|NCT01339091|B3|Baseline|Total|Total of all reporting groups
210627|NCT01339091|B2|Baseline|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
210628|NCT01339091|B1|Baseline|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
210629|NCT01339091|P2|Participant Flow|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
210630|NCT01339091|P1|Participant Flow|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
210631|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
210632|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
210633|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
210634|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
210635|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
210636|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
211410|NCT01335750|O2|Outcome|Multipurpose Solution #2|B&L Renu Fresh Multipurpose Solution
210637|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
210638|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
210639|NCT01339091|E2|Reported Event|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
210640|NCT01339091|E1|Reported Event|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
210641|NCT01339052|B3|Baseline|Total|Total of all reporting groups
210642|NCT01339052|B2|Baseline|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210643|NCT01339052|B1|Baseline|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210644|NCT01339052|P2|Participant Flow|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210645|NCT01339052|P1|Participant Flow|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210646|NCT01339052|O2|Outcome|Cohorts 2: Non-surgical Subjects|"Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity."
210647|NCT01339052|O1|Outcome|Cohorts 1: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity."
210648|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210649|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210650|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210651|NCT01339052|O1|Outcome|Cohort I: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210652|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210653|NCT01339052|O1|Outcome|Cohort I: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210654|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210655|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210656|NCT01339052|O1|Outcome|Cohort I: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210657|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210658|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210659|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210660|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210661|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Participants continued treatment until disease progression or unacceptable toxicity."
210662|NCT01339052|E2|Reported Event|Cohorts 2: Non-surgical Subjects|"Subjects not candidates for surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity."
210663|NCT01339052|E1|Reported Event|Cohorts 1: Surgical Subjects|"Subjects scheduled for surgery
BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery
Surgery: Surgery
BKM120: 100 mg once daily, orally, for 28-day cycles
Patients continued treatment until disease progression or unacceptable toxicity."
210664|NCT01339013|B1|Baseline|All Study Participants|Heat and Moisture Exchanger, then AnaConDa, finally Heat and Moisture Exchanger
211347|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
210665|NCT01339013|P1|Participant Flow|AnaConDa Replaces the Heat and Moisture Exchanger|The conventional Heat and Moisture Exchanger is replaced by the AnaConDa which in turn is replaced by the conventional Heat and Moisture Exchanger.
210666|NCT01339013|O1|Outcome|AnaConDa|Anesthetic Conserving Device (AnaConDa) has a charcoal filter.
210667|NCT01339013|E1|Reported Event|AnaConDa|Anesthetic Conserving Device (AnaConDa or ACD) has a charcoal filter.
210668|NCT01339000|B3|Baseline|Total|Total of all reporting groups
210669|NCT01339000|B2|Baseline|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210670|NCT01339000|B1|Baseline|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210671|NCT01339000|P2|Participant Flow|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210672|NCT01339000|P1|Participant Flow|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210673|NCT01339000|O2|Outcome|Arm B - Sequence Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210674|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210675|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210676|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizationa|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210878|NCT01337635|B1|Baseline|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.
Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
210677|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210678|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210679|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210680|NCT01339000|O1|Outcome|Arm A -Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210681|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210682|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210683|NCT01339000|E2|Reported Event|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210684|NCT01339000|E1|Reported Event|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
210685|NCT01338870|B7|Baseline|Total|Total of all reporting groups
210686|NCT01338870|B6|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210687|NCT01338870|B5|Baseline|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210924|NCT01337336|E1|Reported Event|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
210688|NCT01338870|B4|Baseline|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210689|NCT01338870|B3|Baseline|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210690|NCT01338870|B2|Baseline|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210691|NCT01338870|B1|Baseline|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210692|NCT01338870|P6|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210693|NCT01338870|P5|Participant Flow|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210694|NCT01338870|P4|Participant Flow|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210695|NCT01338870|P3|Participant Flow|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210696|NCT01338870|P2|Participant Flow|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210697|NCT01338870|P1|Participant Flow|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210698|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210699|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210700|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210701|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210702|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210703|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210704|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210705|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210706|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210707|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210708|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210709|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210710|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210711|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210712|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210713|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210714|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210715|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210716|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210717|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210718|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210719|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210720|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210721|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210722|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210723|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210724|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210725|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210726|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210727|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210728|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210729|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210730|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210731|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210732|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210733|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210734|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210735|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210736|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210737|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210738|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210739|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210740|NCT01338870|E6|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210741|NCT01338870|E5|Reported Event|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210742|NCT01338870|E4|Reported Event|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210743|NCT01338870|E3|Reported Event|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210744|NCT01338870|E2|Reported Event|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210745|NCT01338870|E1|Reported Event|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
210746|NCT01338857|B1|Baseline|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.
Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily
Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily
NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
210747|NCT01338857|P1|Participant Flow|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.
Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily
Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily
NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
210748|NCT01338857|O1|Outcome|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.
Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily
Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily
NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
210749|NCT01338857|O1|Outcome|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.
Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily
Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily
NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
210750|NCT01338857|E1|Reported Event|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.
Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily
Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily
NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
210751|NCT01338818|B1|Baseline|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
210752|NCT01338818|P1|Participant Flow|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
210753|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
210754|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
210755|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
210756|NCT01338818|E1|Reported Event|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
210757|NCT01338792|B1|Baseline|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
210758|NCT01338792|P1|Participant Flow|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
210759|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
210760|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
210761|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
210762|NCT01338792|E1|Reported Event|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
210763|NCT01338649|B3|Baseline|Total|Total of all reporting groups
210764|NCT01338649|B2|Baseline|Dim Red Light|"Dim red light control group.
Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
210765|NCT01338649|B1|Baseline|Bright White|"Bright white light treatment group.
Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
210766|NCT01338649|P2|Participant Flow|Dim Red Light|"Dim red light control group.
Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
210767|NCT01338649|P1|Participant Flow|Bright White|"Bright white light treatment group.
Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
210768|NCT01338649|O2|Outcome|Dim Red Light|"Dim red light control group.
Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
210769|NCT01338649|O1|Outcome|Bright White|"Bright white light treatment group.
Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
210770|NCT01338649|E2|Reported Event|Dim Red Light|"Dim red light control group.
Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
210771|NCT01338649|E1|Reported Event|Bright White|"Bright white light treatment group.
Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
210772|NCT01338636|B1|Baseline|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
210773|NCT01338636|P1|Participant Flow|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
210774|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
210775|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
210776|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
210777|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
210778|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
210779|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
210780|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
210781|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
210782|NCT01338636|E1|Reported Event|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
210783|NCT01338610|B4|Baseline|Total|Total of all reporting groups
210784|NCT01338610|B3|Baseline|Vehicle|ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
210785|NCT01338610|B2|Baseline|ESBA105|ESBA 105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
210786|NCT01338610|B1|Baseline|Run-In Only|ESBA105 vehicle
210787|NCT01338610|P3|Participant Flow|Vehicle|ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
210788|NCT01338610|P2|Participant Flow|ESBA105|ESBA105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
210789|NCT01338610|P1|Participant Flow|Run-In Only|ESBA105 vehicle
210790|NCT01338610|O2|Outcome|Vehicle|ESBA105 vehicle
210791|NCT01338610|O1|Outcome|ESBA105|ESBA105 ophthalmic solution
210792|NCT01338610|E3|Reported Event|Vehicle|ESBA105 vehicle
210793|NCT01338610|E2|Reported Event|ESBA105|ESBA105 ophthalmic solution
210794|NCT01338610|E1|Reported Event|Run-In|ESBA105 vehicle, all participants
210795|NCT01338493|B1|Baseline|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
210796|NCT01338493|P1|Participant Flow|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
210797|NCT01338493|O1|Outcome|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
210798|NCT01338493|O1|Outcome|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
210799|NCT01338493|E1|Reported Event|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
210800|NCT01338025|B3|Baseline|Total|Total of all reporting groups
210801|NCT01338025|B2|Baseline|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
210802|NCT01338025|B1|Baseline|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
210803|NCT01338025|P2|Participant Flow|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects were randomized to receive 3TC or FTC (the choice of 3TC or FTC was left to the provider.) In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
3TC or FTC monotherapy: The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.)"
210804|NCT01338025|P1|Participant Flow|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects were randomized to continue their non-suppressive HAART regimen.
In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider.
HAART regimen: The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider."
210805|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
210806|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
210807|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
210808|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
210809|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
210810|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
210811|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
210812|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
210813|NCT01338025|E2|Reported Event|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
210814|NCT01338025|E1|Reported Event|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.
In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
210815|NCT01338012|B1|Baseline|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
210816|NCT01338012|P1|Participant Flow|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
210817|NCT01338012|O1|Outcome|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
210818|NCT01338012|E1|Reported Event|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
210819|NCT01337960|B4|Baseline|Total|Total of all reporting groups
210820|NCT01337960|B3|Baseline|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.
Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
210821|NCT01337960|B2|Baseline|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210822|NCT01337960|B1|Baseline|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210823|NCT01337960|P3|Participant Flow|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.
Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
210824|NCT01337960|P2|Participant Flow|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210825|NCT01337960|P1|Participant Flow|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210826|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.
Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
210873|NCT01337674|E3|Reported Event|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
210827|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210828|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210829|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.
Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
210830|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210831|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210832|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.
Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
210833|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210834|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210874|NCT01337674|E2|Reported Event|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
210875|NCT01337674|E1|Reported Event|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
210835|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.
Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
210836|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210837|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210838|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.
Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
210839|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210840|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210841|NCT01337960|E3|Reported Event|Trll Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.
Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
210842|NCT01337960|E2|Reported Event|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210876|NCT01337635|B3|Baseline|Total|Total of all reporting groups
210877|NCT01337635|B2|Baseline|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.
Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
210843|NCT01337960|E1|Reported Event|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
210844|NCT01337739|B3|Baseline|Total|Total of all reporting groups
210845|NCT01337739|B2|Baseline|Active Comparator|Administration of Dexmedetomidine
210846|NCT01337739|B1|Baseline|Placebo Comparator|Continuous infusion of placebo during operative procedure
210847|NCT01337739|P2|Participant Flow|Active Comparator|Administration of Dexmedetomidine
210848|NCT01337739|P1|Participant Flow|Placebo Comparator|Continuous infusion of placebo during operative procedure
210849|NCT01337739|O2|Outcome|Active Comparator|Administration of Dexmedetomidine
210850|NCT01337739|O1|Outcome|Placebo Comparator|Continuous infusion of placebo during operative procedure
210851|NCT01337739|O2|Outcome|Active Comparator|Administration of Dexmedetomidine
210852|NCT01337739|O1|Outcome|Placebo Comparator|Continuous infusion of placebo during operative procedure
210853|NCT01337739|E2|Reported Event|Active Comparator|Administration of Dexmedetomidine
210854|NCT01337739|E1|Reported Event|Placebo Comparator|Continuous infusion of placebo during operative procedure
210855|NCT01337674|B3|Baseline|Total|Total of all reporting groups
210856|NCT01337674|B2|Baseline|Panel B Participants|Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
210857|NCT01337674|B1|Baseline|Panel A Participants|Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
210858|NCT01337674|P4|Participant Flow|Panel B: PBO + Amlo → MK-4618 + Amlo|Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.
210859|NCT01337674|P3|Participant Flow|Panel B: MK-4618 + Amlo → PBO + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.
210860|NCT01337674|P2|Participant Flow|Panel A: PBO + Met → MK-4618 + Met|Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.
210861|NCT01337674|P1|Participant Flow|Panel A: MK-4618 + Met → PBO + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.
210862|NCT01337674|O2|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
210863|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
210864|NCT01337674|O2|Outcome|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
210865|NCT01337674|O1|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
210866|NCT01337674|O2|Outcome|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
210867|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
210868|NCT01337674|O4|Outcome|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
210869|NCT01337674|O3|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
210870|NCT01337674|O2|Outcome|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
210871|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
210872|NCT01337674|E4|Reported Event|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
210925|NCT01337297|B3|Baseline|Total|Total of all reporting groups
210879|NCT01337635|P2|Participant Flow|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.
Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
210880|NCT01337635|P1|Participant Flow|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.
Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
210881|NCT01337635|O2|Outcome|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.
Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
210882|NCT01337635|O1|Outcome|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.
Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
210883|NCT01337635|E2|Reported Event|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.
Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
210884|NCT01337635|E1|Reported Event|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.
Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
210885|NCT01337609|B4|Baseline|Total|Total of all reporting groups
210886|NCT01337609|B3|Baseline|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
210887|NCT01337609|B2|Baseline|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
210888|NCT01337609|B1|Baseline|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
210889|NCT01337609|P3|Participant Flow|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
210890|NCT01337609|P2|Participant Flow|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
210891|NCT01337609|P1|Participant Flow|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
210892|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
210893|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
210894|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
210895|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
210896|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
210897|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
210898|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
210899|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
210900|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
210901|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
210902|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
210903|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
210904|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
210905|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
210906|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
210907|NCT01337609|E3|Reported Event|Placebo for 30 Days, Followed by GanedenBC30 for 30 Days|
210908|NCT01337609|E2|Reported Event|GanedenBC30 for 60 Days|
210909|NCT01337609|E1|Reported Event|Placebo for 60 Days|
210910|NCT01337336|B3|Baseline|Total|Total of all reporting groups
210911|NCT01337336|B2|Baseline|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
210912|NCT01337336|B1|Baseline|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
210913|NCT01337336|P2|Participant Flow|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
210914|NCT01337336|P1|Participant Flow|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
210915|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
210916|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
210917|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
210918|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
210919|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
210920|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
210921|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
210922|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
210923|NCT01337336|E2|Reported Event|AC Cohort|Anticholinergics (AC) include iotropium, and Ipratropium, Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
210926|NCT01337297|B2|Baseline|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.
transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
210927|NCT01337297|B1|Baseline|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex
transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
210928|NCT01337297|P2|Participant Flow|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.
transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
210929|NCT01337297|P1|Participant Flow|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex
transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
210930|NCT01337297|O2|Outcome|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.
transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
210931|NCT01337297|O1|Outcome|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex
transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
210932|NCT01337297|E2|Reported Event|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.
transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
210933|NCT01337297|E1|Reported Event|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex
transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
210934|NCT01337167|B3|Baseline|Total|Total of all reporting groups
210935|NCT01337167|B2|Baseline|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210936|NCT01337167|B1|Baseline|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210937|NCT01337167|P2|Participant Flow|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210938|NCT01337167|P1|Participant Flow|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210939|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210940|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210941|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210942|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210943|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210944|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210945|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210946|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210947|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210948|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210949|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210950|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210951|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210952|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210953|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210954|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210955|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210956|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210957|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210958|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210959|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210960|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210961|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210962|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210963|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210964|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210965|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
211348|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
210966|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210967|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210968|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210969|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210970|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210971|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210972|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210973|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210974|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210975|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210976|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210977|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210978|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210979|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210980|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210981|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210982|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210983|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210984|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210985|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210986|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210987|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
211349|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
210988|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210989|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210990|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210991|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210992|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210993|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210994|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210995|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210996|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210997|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210998|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
210999|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
211000|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
211001|NCT01337167|E2|Reported Event|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
211002|NCT01337167|E1|Reported Event|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
211003|NCT01337115|B3|Baseline|Total|Total of all reporting groups
211004|NCT01337115|B2|Baseline|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
211005|NCT01337115|B1|Baseline|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
211006|NCT01337115|P2|Participant Flow|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
211007|NCT01337115|P1|Participant Flow|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
211008|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
211009|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
211010|NCT01337115|O2|Outcome|CFNB+Single Shot SNB|Patients with additional sciatic nerve block
211011|NCT01337115|O1|Outcome|CFNB|Patients with continuous femoral nerve block
211012|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
211045|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211013|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
211014|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
211015|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
211016|NCT01337115|E2|Reported Event|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
211017|NCT01337115|E1|Reported Event|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
211018|NCT01337076|B1|Baseline|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
211019|NCT01337076|P1|Participant Flow|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
211020|NCT01337076|O1|Outcome|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
211021|NCT01337076|E1|Reported Event|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
211022|NCT01337050|B4|Baseline|Total|Total of all reporting groups
211023|NCT01337050|B3|Baseline|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211024|NCT01337050|B2|Baseline|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211025|NCT01337050|B1|Baseline|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211026|NCT01337050|P3|Participant Flow|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211027|NCT01337050|P2|Participant Flow|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211028|NCT01337050|P1|Participant Flow|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211029|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211030|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211031|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211032|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211033|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211034|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211035|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211036|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211037|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211038|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211039|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211040|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211041|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211042|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211043|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211044|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211046|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211047|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211048|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211049|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211050|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211051|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211052|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211053|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211054|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211055|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211056|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211057|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211058|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211059|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211060|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211061|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211062|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211063|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211064|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211065|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211066|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211067|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211068|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211069|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211070|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211071|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211072|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211073|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211074|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211075|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211076|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211077|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211078|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211079|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211080|NCT01337050|O1|Outcome|PF-03446962|PF-03446962 4.5, 7.0 or 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211081|NCT01337050|O1|Outcome|PF-03446962|PF-03446962 4.5, 7.0 or 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211082|NCT01337050|E3|Reported Event|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211083|NCT01337050|E2|Reported Event|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211084|NCT01337050|E1|Reported Event|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
211085|NCT01336972|B4|Baseline|Total|Total of all reporting groups
211086|NCT01336972|B3|Baseline|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211087|NCT01336972|B2|Baseline|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211088|NCT01336972|B1|Baseline|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211089|NCT01336972|P3|Participant Flow|eGFR <30 ml/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211090|NCT01336972|P2|Participant Flow|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211091|NCT01336972|P1|Participant Flow|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211092|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211093|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211094|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211095|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211096|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211097|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211098|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211099|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211100|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211101|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211102|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211103|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211104|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211105|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211106|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211107|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211108|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211109|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211110|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211111|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211112|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211113|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211114|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211115|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211116|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211117|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211118|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211119|NCT01336972|O3|Outcome|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
211120|NCT01336972|O2|Outcome|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211121|NCT01336972|O1|Outcome|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211122|NCT01336972|E3|Reported Event|eGFR <30 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211123|NCT01336972|E2|Reported Event|eGFR 30-60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211124|NCT01336972|E1|Reported Event|eGFR > 60 mL/Min/1.73m2|Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
211125|NCT01336894|B3|Baseline|Total|Total of all reporting groups
211126|NCT01336894|B2|Baseline|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
211127|NCT01336894|B1|Baseline|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
211128|NCT01336894|P2|Participant Flow|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
211129|NCT01336894|P1|Participant Flow|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
211130|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
211131|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
211132|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
211133|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
211134|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
211135|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
211136|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
211137|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
211138|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
211139|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
211140|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
211141|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
211142|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
211143|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
211144|NCT01336894|E2|Reported Event|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
211145|NCT01336894|E1|Reported Event|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
211146|NCT01336764|B3|Baseline|Total|Total of all reporting groups
211147|NCT01336764|B2|Baseline|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.
Control: Unguided listening to radio/music."
211148|NCT01336764|B1|Baseline|Active|"individual coping self-statements and stimulus guided paced breathing.
Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
211149|NCT01336764|P2|Participant Flow|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.
Control: Unguided listening to radio/music."
211150|NCT01336764|P1|Participant Flow|Active|"individual coping self-statements and stimulus guided paced breathing.
Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
211151|NCT01336764|O2|Outcome|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.
Control: Unguided listening to radio/music."
211152|NCT01336764|O1|Outcome|Active|"individual coping self-statements and stimulus guided paced breathing.
Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
211153|NCT01336764|E2|Reported Event|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.
Control: Unguided listening to radio/music."
211154|NCT01336764|E1|Reported Event|Active|"individual coping self-statements and stimulus guided paced breathing.
Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
211155|NCT01336738|B6|Baseline|Total|Total of all reporting groups
211156|NCT01336738|B5|Baseline|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211157|NCT01336738|B4|Baseline|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211158|NCT01336738|B3|Baseline|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211159|NCT01336738|B2|Baseline|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211160|NCT01336738|B1|Baseline|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211161|NCT01336738|P5|Participant Flow|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211162|NCT01336738|P4|Participant Flow|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211163|NCT01336738|P3|Participant Flow|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211164|NCT01336738|P2|Participant Flow|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211236|NCT01336608|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received fluticasone furoate (FF)/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211165|NCT01336738|P1|Participant Flow|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211166|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211167|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211168|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211169|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211170|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211171|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211172|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211173|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211174|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211175|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211176|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211177|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211178|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211179|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211180|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211181|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211182|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211183|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211184|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211342|NCT01335971|P3|Participant Flow|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
211185|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211186|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211187|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211188|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211189|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211190|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211191|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211192|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211193|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211194|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211195|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211196|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211197|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211198|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211199|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211200|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211201|NCT01336738|E5|Reported Event|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211202|NCT01336738|E4|Reported Event|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211203|NCT01336738|E3|Reported Event|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211204|NCT01336738|E2|Reported Event|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211343|NCT01335971|P2|Participant Flow|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
211205|NCT01336738|E1|Reported Event|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
211206|NCT01336712|B1|Baseline|Myeloablative Haploidentical Transplant|"Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
211207|NCT01336712|P1|Participant Flow|Myeloablative Haploidentical Transplant|"Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m^2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4
Patient follow up x6 months"
211208|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
211209|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
211210|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
211211|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
211212|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
211213|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
211214|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
211215|NCT01336712|E1|Reported Event|Myeloablative Haploidentical Transplant|"Haplo transplant
Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
211216|NCT01336647|B4|Baseline|Total|Total of all reporting groups
211217|NCT01336647|B3|Baseline|Vehicle|Vehicle Gel without active ingredient of Ha44.
211218|NCT01336647|B2|Baseline|High-Dose Ha44|High-Dose Ha44 0.74% Gel, topically administered to hair and scalp for 10 minutes
211219|NCT01336647|B1|Baseline|Low Dose Ha44 Gel|Low-Dose Ha44 0.37% Gel, topically administered to hair and scalp for 10 minutes
211220|NCT01336647|P3|Participant Flow|Vehicle|Vehicle Ha44 Gel with no active incident it was administered topically for 10 minutes as a single dose.
211221|NCT01336647|P2|Participant Flow|High-Dose Ha44|High-Dose Ha44 Gel 0.74% it was administered topically for 10 minutes as a single dose
211222|NCT01336647|P1|Participant Flow|Low Dose Ha 44 Gel|Low-Dose Ha44 Gel 0.37%, it was administered topically for 10 minutes as a single dose.
211223|NCT01336647|O3|Outcome|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
211224|NCT01336647|O2|Outcome|High Dose Ha44|High-Dose Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
211225|NCT01336647|O1|Outcome|Low Dose Ha44|Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.
211226|NCT01336647|O3|Outcome|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
211227|NCT01336647|O2|Outcome|Hig Dose Ha44|Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
211228|NCT01336647|O1|Outcome|Low Dose Ha44|Ha44 0.37% Gel administered topically to hair and scalp for 10 minutes.
211229|NCT01336647|E3|Reported Event|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
211230|NCT01336647|E2|Reported Event|High Dose Ha44 Gel|High-Dose Ha44 0.74% Gel, administered topically to hair and scalp for 10 minutes.
211231|NCT01336647|E1|Reported Event|Low Dose Ha44 Gel|Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.
211232|NCT01336608|B4|Baseline|Total|Total of all reporting groups
211233|NCT01336608|B3|Baseline|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211234|NCT01336608|B2|Baseline|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211235|NCT01336608|B1|Baseline|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211237|NCT01336608|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 micrograms (µg) inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211238|NCT01336608|P2|Participant Flow|Placebo QD|Participants received placebo QD in the morning via a dry powder inhaler (DPI) for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211239|NCT01336608|P1|Participant Flow|Placebo-Run-in|Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler [MDI] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.
211240|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211241|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211242|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211243|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211244|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211245|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211246|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211247|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211248|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211249|NCT01336608|E3|Reported Event|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211250|NCT01336608|E2|Reported Event|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211251|NCT01336608|E1|Reported Event|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
211252|NCT01336569|B1|Baseline|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
211253|NCT01336569|P1|Participant Flow|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
211254|NCT01336569|O1|Outcome|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
211255|NCT01336569|E1|Reported Event|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
211256|NCT01336296|B3|Baseline|Total|Total of all reporting groups
211257|NCT01336296|B2|Baseline|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211258|NCT01336296|B1|Baseline|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211259|NCT01336296|P2|Participant Flow|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211260|NCT01336296|P1|Participant Flow|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211261|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211344|NCT01335971|P1|Participant Flow|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211262|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211263|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211264|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211265|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211266|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211267|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211268|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211269|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211270|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211271|NCT01336296|E2|Reported Event|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211272|NCT01336296|E1|Reported Event|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)
mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
211273|NCT01336205|B3|Baseline|Total|Total of all reporting groups
211274|NCT01336205|B2|Baseline|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
211275|NCT01336205|B1|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
211276|NCT01336205|P2|Participant Flow|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
211277|NCT01336205|P1|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
211278|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
211279|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
211280|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
211281|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
211282|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
211283|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
211284|NCT01336205|E2|Reported Event|Usual Care|
211285|NCT01336205|E1|Reported Event|NKTR-118 25 mg|
211286|NCT01336140|B3|Baseline|Total|Total of all reporting groups
211287|NCT01336140|B2|Baseline|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
211288|NCT01336140|B1|Baseline|Aminophylline|75 mg of intravenous aminophylline.
211289|NCT01336140|P2|Participant Flow|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
211290|NCT01336140|P1|Participant Flow|Aminophylline|75 mg of intravenous aminophylline.
211291|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
211292|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
211293|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
211294|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
211295|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
211296|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
211297|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
211298|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
211299|NCT01336140|E2|Reported Event|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
211300|NCT01336140|E1|Reported Event|Aminophylline|75 mg of intravenous aminophylline.
211301|NCT01336023|B4|Baseline|Total|Total of all reporting groups
211302|NCT01336023|B3|Baseline|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211350|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211303|NCT01336023|B2|Baseline|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211304|NCT01336023|B1|Baseline|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211305|NCT01336023|P3|Participant Flow|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211306|NCT01336023|P2|Participant Flow|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211307|NCT01336023|P1|Participant Flow|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211308|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211309|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211310|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211311|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211312|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211313|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211314|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211315|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211316|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211317|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211318|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211319|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211320|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211321|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211322|NCT01336023|E3|Reported Event|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211323|NCT01336023|E2|Reported Event|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211324|NCT01336023|E1|Reported Event|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
211325|NCT01335997|B3|Baseline|Total|Total of all reporting groups
211326|NCT01335997|B2|Baseline|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
211327|NCT01335997|B1|Baseline|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
211328|NCT01335997|P2|Participant Flow|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
211329|NCT01335997|P1|Participant Flow|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
211330|NCT01335997|O2|Outcome|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
211331|NCT01335997|O1|Outcome|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
211332|NCT01335997|O2|Outcome|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
211333|NCT01335997|O1|Outcome|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
211334|NCT01335997|E4|Reported Event|Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM|ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period III)
211335|NCT01335997|E3|Reported Event|Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA|ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period III)
211336|NCT01335997|E2|Reported Event|Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM|ERN/LRPT 1 g + SIMVA 10 mg for 4 weeks (Period I) followed by ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period II)
211337|NCT01335997|E1|Reported Event|Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA|ERN/LRPT/SIMVA 1 g/10 mg for 4 weeks (Period I) followed by ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period II)
211338|NCT01335971|B4|Baseline|Total|Total of all reporting groups
211339|NCT01335971|B3|Baseline|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
211340|NCT01335971|B2|Baseline|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
211341|NCT01335971|B1|Baseline|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211351|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
211352|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
211353|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211354|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
211355|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
211356|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211357|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
211358|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
211359|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211360|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
211361|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
211362|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211363|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
211364|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
211365|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211366|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
211367|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
211368|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211369|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
211370|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
211371|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211372|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
211373|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
211374|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211375|NCT01335971|E3|Reported Event|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth
Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
211376|NCT01335971|E2|Reported Event|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
211377|NCT01335971|E1|Reported Event|Placebo|"Microcrystalline cellulose
Placebo: Microcrystalline cellulose once daily by mouth"
211378|NCT01335867|B3|Baseline|Total|Total of all reporting groups
211379|NCT01335867|B2|Baseline|Placebo|Placebo: Placebo pills
211380|NCT01335867|B1|Baseline|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
211381|NCT01335867|P2|Participant Flow|Placebo|Placebo: Placebo pills
211382|NCT01335867|P1|Participant Flow|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
211383|NCT01335867|O2|Outcome|Placebo|Placebo: Placebo pills
211384|NCT01335867|O1|Outcome|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
211385|NCT01335867|O2|Outcome|Placebo|Placebo: Placebo pills
211386|NCT01335867|O1|Outcome|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
211387|NCT01335867|E2|Reported Event|Placebo|Placebo: Placebo pills
211388|NCT01335867|E1|Reported Event|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
211389|NCT01335789|B3|Baseline|Total|Total of all reporting groups
211390|NCT01335789|B2|Baseline|Saline|"intranasal administration
Saline: 40 IUs"
211391|NCT01335789|B1|Baseline|Oxytocin|"intranasal administration
Oxytocin: 40 IUs"
211392|NCT01335789|P2|Participant Flow|Saline|"intranasal administration
Saline: 40 IUs"
211393|NCT01335789|P1|Participant Flow|Oxytocin|"intranasal administration
Oxytocin: 40 IUs"
211394|NCT01335789|O2|Outcome|Saline|"intranasal administration
Saline: 40 IUs"
211395|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration
Oxytocin: 40 IUs"
211396|NCT01335789|O2|Outcome|Saline|"intranasal administration
Saline: 40 IUs"
211397|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration
Oxytocin: 40 IUs"
211398|NCT01335789|O2|Outcome|Saline|"intranasal administration
Saline: 40 IUs"
211399|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration
Oxytocin: 40 IUs"
211400|NCT01335789|E2|Reported Event|Saline|"intranasal administration
Saline: 40 IUs"
211401|NCT01335789|E1|Reported Event|Oxytocin|"intranasal administration
Oxytocin: 40 IUs"
211402|NCT01335750|B1|Baseline|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
211403|NCT01335750|P1|Participant Flow|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
211404|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Solution
211411|NCT01335750|O1|Outcome|Mutlipurpose Solution #1|Optifree Replenish Multipurpose Solution
211412|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Solution
211413|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
211414|NCT01335750|O2|Outcome|Multipurpose Solution #2|Optifree Replenish Multipurpose Solution
211415|NCT01335750|O1|Outcome|Multipurpose Solution #1|B&L Renu Fresh Multipurpose Solution
211416|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Multipurpose Solution
211417|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
211418|NCT01335750|O2|Outcome|Multipurpose Solution #2|Optifree Replenish Multipurpose Solution
211419|NCT01335750|O1|Outcome|Multipurpose Solution #1|B&L Renu Fresh Multipurpose Solution
211420|NCT01335750|E1|Reported Event|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
211421|NCT01335724|B3|Baseline|Total|Total of all reporting groups
211422|NCT01335724|B2|Baseline|Placebo Gel|
211423|NCT01335724|B1|Baseline|Diclofenac Diethylamine 1.16% Gel|
211424|NCT01335724|P2|Participant Flow|Placebo Gel|
211425|NCT01335724|P1|Participant Flow|Diclofenac Diethylamine 1.16% Gel|
211426|NCT01335724|O2|Outcome|Placebo Gel|
211427|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
211428|NCT01335724|O2|Outcome|Placebo Gel|
211429|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
211430|NCT01335724|O2|Outcome|Placebo Gel|
211431|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
211432|NCT01335724|E2|Reported Event|Placebo Gel|
211433|NCT01335724|E1|Reported Event|Diclofenac Diethylamine 1.16% Gel|
211434|NCT01335698|B6|Baseline|Total|Total of all reporting groups
211435|NCT01335698|B5|Baseline|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211436|NCT01335698|B4|Baseline|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211437|NCT01335698|B3|Baseline|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211438|NCT01335698|B2|Baseline|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211439|NCT01335698|B1|Baseline|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks.Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211440|NCT01335698|P5|Participant Flow|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211441|NCT01335698|P4|Participant Flow|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211442|NCT01335698|P3|Participant Flow|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211443|NCT01335698|P2|Participant Flow|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211444|NCT01335698|P1|Participant Flow|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211445|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211446|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211447|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211448|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211449|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211450|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211451|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211452|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211453|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211454|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211455|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211456|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211537|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211457|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211458|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211459|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211460|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211461|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211462|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211463|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211464|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211465|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets,100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211466|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211467|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211468|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211469|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211539|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211470|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211471|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211472|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211473|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211474|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211475|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211476|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211477|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211478|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211479|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211480|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211481|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211482|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211835|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks
Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
211483|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211484|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211485|NCT01335698|E5|Reported Event|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211486|NCT01335698|E4|Reported Event|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks.Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211487|NCT01335698|E3|Reported Event|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211488|NCT01335698|E2|Reported Event|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211489|NCT01335698|E1|Reported Event|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
211490|NCT01335542|B3|Baseline|Total|Total of all reporting groups
211491|NCT01335542|B2|Baseline|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
211492|NCT01335542|B1|Baseline|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
211493|NCT01335542|P2|Participant Flow|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
211494|NCT01335542|P1|Participant Flow|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
211495|NCT01335542|O2|Outcome|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
211496|NCT01335542|O1|Outcome|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
211497|NCT01335542|E2|Reported Event|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
211538|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211498|NCT01335542|E1|Reported Event|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
211499|NCT01335477|B3|Baseline|Total|Total of all reporting groups
211500|NCT01335477|B2|Baseline|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211501|NCT01335477|B1|Baseline|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211502|NCT01335477|P2|Participant Flow|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211503|NCT01335477|P1|Participant Flow|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211504|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211505|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211506|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211507|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211508|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211509|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211510|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211511|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211512|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211513|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211514|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211515|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211516|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211517|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211518|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211519|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211520|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211521|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211522|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211523|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211524|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211525|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211526|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211527|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211528|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211529|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211530|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211531|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211532|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211533|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211534|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211535|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211536|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211540|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211541|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211542|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211543|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211544|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211545|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211546|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211547|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211548|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211549|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211550|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211551|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211552|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211553|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211554|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211555|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211556|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211557|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211558|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211559|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211560|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211561|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
211562|NCT01335477|E2|Reported Event|Nintedanib 150mg Bid|Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.
211563|NCT01335477|E1|Reported Event|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules.
211564|NCT01335464|B3|Baseline|Total|Total of all reporting groups
211565|NCT01335464|B2|Baseline|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211566|NCT01335464|B1|Baseline|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211567|NCT01335464|P2|Participant Flow|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211568|NCT01335464|P1|Participant Flow|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211569|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211570|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211571|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211572|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211573|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211574|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211575|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211576|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211577|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211578|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211579|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211580|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211581|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211582|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211583|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211584|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211585|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211586|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211587|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211588|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211589|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211590|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211591|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211592|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211593|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211594|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211595|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211596|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211597|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211598|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211599|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211600|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211601|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211602|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211603|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211604|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211605|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211606|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211607|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211608|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211609|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211610|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211611|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211612|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211613|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211614|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211615|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211616|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211617|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211618|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211619|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211620|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211836|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks
Placebo: Placebo for 6 weeks"
211621|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211622|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211623|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211624|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211625|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).
Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
211626|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
211627|NCT01335464|E2|Reported Event|Nintedanib 150mg Bid|Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.
211628|NCT01335464|E1|Reported Event|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules.
211629|NCT01335308|B4|Baseline|Total|Total of all reporting groups
211630|NCT01335308|B3|Baseline|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
211631|NCT01335308|B2|Baseline|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
211632|NCT01335308|B1|Baseline|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
211633|NCT01335308|P3|Participant Flow|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
211634|NCT01335308|P2|Participant Flow|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
211635|NCT01335308|P1|Participant Flow|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
211636|NCT01335308|O3|Outcome|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
211637|NCT01335308|O2|Outcome|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
211638|NCT01335308|O1|Outcome|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
211639|NCT01335308|O3|Outcome|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
211640|NCT01335308|O2|Outcome|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
211641|NCT01335308|O1|Outcome|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
211642|NCT01335308|O3|Outcome|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
211643|NCT01335308|O2|Outcome|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
211644|NCT01335308|O1|Outcome|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
211691|NCT01335061|E1|Reported Event|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
211645|NCT01335308|O3|Outcome|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
211646|NCT01335308|O2|Outcome|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
211647|NCT01335308|O1|Outcome|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
211648|NCT01335308|E3|Reported Event|Higher Dose Motivational Interviewing|Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
211649|NCT01335308|E2|Reported Event|Moderate Dose Motivational Interviewing|Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
211650|NCT01335308|E1|Reported Event|Standard Care With Education Materials|Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
211651|NCT01335230|B5|Baseline|Total|Total of all reporting groups
211652|NCT01335230|B4|Baseline|10 Control Subjects|10 subjects without HIV, HCV, or both
211653|NCT01335230|B3|Baseline|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
211654|NCT01335230|B2|Baseline|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
211655|NCT01335230|B1|Baseline|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
211656|NCT01335230|P4|Participant Flow|10 Control Subjects|10 subjects without HIV, HCV, or both
211657|NCT01335230|P3|Participant Flow|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
211658|NCT01335230|P2|Participant Flow|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
211659|NCT01335230|P1|Participant Flow|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
211660|NCT01335230|O4|Outcome|10 Control Subjects|10 subjects without HIV, HCV, or both
211661|NCT01335230|O3|Outcome|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
211662|NCT01335230|O2|Outcome|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
211663|NCT01335230|O1|Outcome|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
211664|NCT01335230|E4|Reported Event|10 Control Subjects|10 subjects without HIV, HCV, or both
211665|NCT01335230|E3|Reported Event|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
211666|NCT01335230|E2|Reported Event|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
211667|NCT01335230|E1|Reported Event|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
211668|NCT01335191|B3|Baseline|Total|Total of all reporting groups
211669|NCT01335191|B2|Baseline|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
211670|NCT01335191|B1|Baseline|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
211671|NCT01335191|P2|Participant Flow|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
211672|NCT01335191|P1|Participant Flow|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
211673|NCT01335191|O2|Outcome|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
211674|NCT01335191|O1|Outcome|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
211675|NCT01335191|E2|Reported Event|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
211676|NCT01335191|E1|Reported Event|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
211677|NCT01335061|B1|Baseline|All Participants|The data for all the participants is presented.
211678|NCT01335061|P1|Participant Flow|All Participants|The data for all the participants is presented.
211679|NCT01335061|O1|Outcome|All Participants|The data for all the participants is presented.
211680|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
211681|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
211682|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
211683|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
211684|NCT01335061|O1|Outcome|All Participants|The data for all the participants is presented.
211685|NCT01335061|O1|Outcome|All Population|The data for all the participants is presented.
211686|NCT01335061|O2|Outcome|On-Demand Therapy-Follow-up Infusions|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
211687|NCT01335061|O1|Outcome|On-Demand Therapy-First Infusion|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
211688|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100 IU/kg once weekly was initiated at Visit 4.
211689|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
211690|NCT01335061|E2|Reported Event|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
211692|NCT01334957|B1|Baseline|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
211693|NCT01334957|P1|Participant Flow|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. A minimum of one dose of intravenous ibuprofen will be administered. At the discretion of the investigator, up to three additional doses of 800 mg intravenous ibuprofen may be administered at six hour intervals.
Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
211694|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
211695|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
211696|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
211697|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
211698|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
211699|NCT01334957|E1|Reported Event|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
211700|NCT01334944|B1|Baseline|Intravenous Ibuprofen|"Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Intravenous ibuprofen: 400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
211701|NCT01334944|P2|Participant Flow|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
211702|NCT01334944|P1|Participant Flow|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
211703|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211704|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211705|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
211706|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
211707|NCT01334944|O1|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
211708|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
211709|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211710|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211711|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211712|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211713|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211714|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211715|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
211787|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >70%|Participants in the acute urinary retention outcomes cohort with an MPR >70%
211716|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
211717|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211718|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211719|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211720|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
211721|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
211722|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
211723|NCT01334944|E2|Reported Event|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
211724|NCT01334944|E1|Reported Event|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
211725|NCT01334918|B3|Baseline|Total|Total of all reporting groups
211726|NCT01334918|B2|Baseline|Sequence 2: MDCT - SPECT|"Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure.
Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
211727|NCT01334918|B1|Baseline|Sequence 1: SPECT - MDCT|"Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure.
Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure.
Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
211728|NCT01334918|P2|Participant Flow|Sequence 2: MDCT - SPECT|"Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure.
Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
211729|NCT01334918|P1|Participant Flow|Sequence 1: SPECT - MDCT|"Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure.
Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure.
Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
211730|NCT01334918|O1|Outcome|SPECT + MDCT|Participants underwent both a rest and stress SPECT series and a rest and stress MDCT series.
211731|NCT01334918|O3|Outcome|CTP: All Fixed Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
211732|NCT01334918|O2|Outcome|CTP: ≥ 1 Fixed Defects|Participants with ≥ 1 fixed defects as assessed by regadenoson stress computed tomography perfusion (CTP).
211733|NCT01334918|O1|Outcome|CTP: 0 Fixed Defects|Participants with zero fixed defects as assessed by regadenoson stress computed tomography perfusion (CTP).
211734|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
211735|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
211736|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
211737|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
211738|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
211739|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
211740|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
211741|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
211742|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
211743|NCT01334918|O6|Outcome|MDCT: Reviewer 3|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
211744|NCT01334918|O5|Outcome|MDCT: Reviewer 2|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
211745|NCT01334918|O4|Outcome|MDCT: Reviewer 1|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
211746|NCT01334918|O3|Outcome|SPECT: Reviewer 3|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 3.
211747|NCT01334918|O2|Outcome|SPECT: Reviewer 2|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 2.
211748|NCT01334918|O1|Outcome|SPECT: Reviewer 1|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 1.
211749|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
211750|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
211751|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
211752|NCT01334918|E2|Reported Event|MDCT|Multidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline.
211753|NCT01334918|E1|Reported Event|SPECT|Resting SPECT imaging was performed prior to regadenoson stress SPECT imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection.
211754|NCT01334866|B1|Baseline|Study Completion Cohort|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
211755|NCT01334866|P1|Participant Flow|Minimally Invasive Coronary Artery Bypass Grafting|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
211756|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
211757|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
211758|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
211759|NCT01334866|O1|Outcome|Study Procedure Cohort|89 Subjects received study treatment
211760|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
211761|NCT01334866|E1|Reported Event|Study Procedure Cohort|89 Subjects received study treatment
211762|NCT01334723|B3|Baseline|Total|Total of all reporting groups
211763|NCT01334723|B2|Baseline|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
211764|NCT01334723|B1|Baseline|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
211765|NCT01334723|P2|Participant Flow|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
211766|NCT01334723|P1|Participant Flow|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
211767|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
211768|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
211769|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
211770|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
211771|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
211772|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
211773|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
211774|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
211775|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
211776|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
211777|NCT01334723|O4|Outcome|Prostate Surgery Outcomes Cohort, MPR >80%|Participants in the prostate surgery outcomes cohort with an MPR >80%
211778|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=80%|Participants in the prostate surgery outcomes cohort with an MPR <=80%
211779|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >80%|Participants in the acute urinary retention outcomes cohort with an >80%
211780|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=80%|Participants in the acute urinary retention outcomes cohort with an MPR <=80%
211781|NCT01334723|O4|Outcome|Prostate Surgery Outcomes Cohort, MPR >75%|Participants in the prostate surgery outcomes cohort with an MPR >75%
211782|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=75%|Participants in the prostate surgery outcomes cohort with an MPR <=75%
211783|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >75%|Participants in the acute urinary retention outcomes cohort with an MPR >75%
211784|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=75%|Among the Participants in the acute urinary retention outcomes cohort with an MPR <=75%
211785|NCT01334723|O4|Outcome|Prostate Surgery Outocomes Cohort, MPR >70%|Participants in the prostate surgery outcomes cohort with an MPR >70%
211786|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=70%|Participants in the prostate surgery outcomes cohort with an MPR <=70%
211788|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=70%|Participants in the acute urinary retention outcomes cohort with an MPR <=70%
211789|NCT01334723|E2|Reported Event|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
211790|NCT01334723|E1|Reported Event|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
211791|NCT01334710|B1|Baseline|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.
Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
211792|NCT01334710|P1|Participant Flow|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.
Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
211793|NCT01334710|O1|Outcome|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.
Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
211794|NCT01334710|E1|Reported Event|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.
Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
211795|NCT01334606|B1|Baseline|All Study Participants|This includes all subjects randomized to either intervention sequence. Since only 3 subjects completed both study periods, the data are not presented by intervention.
211796|NCT01334606|P1|Participant Flow|All Study Participants|Since only 3 subjects completed both periods of the crossover study before it was prematurely terminated, the primary endpoint analysis could not be performed. Therefore, no tabulations by intervention were prepared.
211797|NCT01334606|O1|Outcome|All Subjects|Due to early termination of the study, only 3 subjects completed both study periods. Analysis of the primary outcome measure requires FRU data from both study periods. Due to the lack of sufficient data, no analysis was performed.
211798|NCT01334606|E3|Reported Event|8mmx31G Pen Needle|Subjects that used the 8mmx31G pen needle, either during Study Period 1 or Study Period 2
211799|NCT01334606|E2|Reported Event|4mmx32G Pen Needle|Subjects that used the 4mmx32G pen needle, either during Study Period 1 or Study Period 2
211800|NCT01334606|E1|Reported Event|All Study Participants|This includes all subjects that participated in the study. A total of 22 adverse events were reported. The investigator reported that 14 of 22 events were not related to the study product, and 8 of 22 events were unlikely related to the study product.
211801|NCT01334554|B3|Baseline|Total|Total of all reporting groups
211802|NCT01334554|B2|Baseline|Placebo|Placebo three times a day for 4 weeks
211803|NCT01334554|B1|Baseline|Sildenafil|Sildenafil 20 mg three times a day for 4 weeks
211804|NCT01334554|P2|Participant Flow|Placebo|Participants received placebo three times a day for 4 weeks
211805|NCT01334554|P1|Participant Flow|Sildenafil|Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks
211806|NCT01334554|O2|Outcome|Placebo|"placebo
Placebo: No active drug"
211807|NCT01334554|O1|Outcome|Sildenafil|"Sildenafil 20 mg three times a day
Sildenafil: 20 mg three times a day."
211808|NCT01334554|O2|Outcome|Placebo|Placebo tablets, 1 tablet three times a day
211809|NCT01334554|O1|Outcome|Sildenafil|Sildenafil: 20 mg TID
211810|NCT01334554|E2|Reported Event|Placebo|Participants received placebo three times a day for 4 weeks
211811|NCT01334554|E1|Reported Event|Sildenafil|Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks
211812|NCT01334515|B3|Baseline|Total|Total of all reporting groups
211813|NCT01334515|B2|Baseline|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.
hu14.18-IL2 fusion protein: Given IV
isotretinoin: Given PO
sargramostim: Given SC
laboratory biomarker analysis: Correlative studies"
211814|NCT01334515|B1|Baseline|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.
hu14.18-IL2 fusion protein: Given IV
isotretinoin: Given PO
sargramostim: Given SC
laboratory biomarker analysis: Correlative studies"
211815|NCT01334515|P2|Participant Flow|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.
hu14.18-IL2 fusion protein: Given IV
isotretinoin: Given PO
sargramostim: Given SC
laboratory biomarker analysis: Correlative studies"
214036|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
211816|NCT01334515|P1|Participant Flow|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.
hu14.18-IL2 fusion protein: Given IV
isotretinoin: Given PO
sargramostim: Given SC
laboratory biomarker analysis: Correlative studies"
211817|NCT01334515|O2|Outcome|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.
hu14.18-IL2 fusion protein: Given IV
isotretinoin: Given PO
sargramostim: Given SC
laboratory biomarker analysis: Correlative studies"
211818|NCT01334515|O1|Outcome|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.
hu14.18-IL2 fusion protein: Given IV
isotretinoin: Given PO
sargramostim: Given SC
laboratory biomarker analysis: Correlative studies"
211819|NCT01334515|O2|Outcome|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.
hu14.18-IL2 fusion protein: Given IV
isotretinoin: Given PO
sargramostim: Given SC
laboratory biomarker analysis: Correlative studies"
211820|NCT01334515|O1|Outcome|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.
hu14.18-IL2 fusion protein: Given IV
isotretinoin: Given PO
sargramostim: Given SC
laboratory biomarker analysis: Correlative studies"
211821|NCT01334515|E2|Reported Event|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.
hu14.18-IL2 fusion protein: Given IV
isotretinoin: Given PO
sargramostim: Given SC
laboratory biomarker analysis: Correlative studies"
211822|NCT01334515|E1|Reported Event|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.
hu14.18-IL2 fusion protein: Given IV
isotretinoin: Given PO
sargramostim: Given SC
laboratory biomarker analysis: Correlative studies"
211823|NCT01334229|B3|Baseline|Total|Total of all reporting groups
211824|NCT01334229|B2|Baseline|Placebo First Then Sitagliptin|First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
211825|NCT01334229|B1|Baseline|Sitagliptin First Then Placebo|First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Pacebo for 6 weeks
211826|NCT01334229|P2|Participant Flow|Placebo First Then Sitagliptin|First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
211827|NCT01334229|P1|Participant Flow|Sitagliptin Then Placebo|First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Placebo for 6 weeks
211828|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks
Placebo: Placebo for 6 weeks"
211829|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks
Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
211830|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks
Placebo: Placebo for 6 weeks"
211831|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks
Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
211832|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks
Placebo: Placebo for 6 weeks"
211833|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks
Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
211834|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks
Placebo: Placebo for 6 weeks"
211837|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks
Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
211838|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks
Placebo: Placebo for 6 weeks"
211839|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks
Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
211840|NCT01334229|E2|Reported Event|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks
Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
211841|NCT01334229|E1|Reported Event|Placebo|"Placebo for 6 weeks
Placebo: Placebo for 6 weeks"
211842|NCT01334216|B3|Baseline|Total|Total of all reporting groups
211843|NCT01334216|B2|Baseline|CHICA Placebo|"This arm had CHICA without the smoking cessation module
CHICA Placebo: This was CHICA without the study module."
211844|NCT01334216|B1|Baseline|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on
CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
211845|NCT01334216|P2|Participant Flow|CHICA Placebo|"This arm had CHICA without the smoking cessation module
CHICA Placebo: This was CHICA without the study module."
211846|NCT01334216|P1|Participant Flow|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on
CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
211847|NCT01334216|O2|Outcome|CHICA Placebo|"This arm had CHICA without the smoking cessation module
CHICA Placebo: This was CHICA without the study module."
211848|NCT01334216|O1|Outcome|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on
CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
211849|NCT01334216|E2|Reported Event|CHICA Placebo|"This arm had CHICA without the smoking cessation module
CHICA Placebo: This was CHICA without the study module."
211850|NCT01334216|E1|Reported Event|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on
CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
211851|NCT01334125|B3|Baseline|Total|Total of all reporting groups
211852|NCT01334125|B2|Baseline|Placebo|"1 capsule once daily by mouth for 9 months
Placebo: 1 capsules once daily by mouth for 9 months"
211853|NCT01334125|B1|Baseline|Metformin|"Metformin 1000 mg once daily by mouth for 9 months
Metformin: Metformin 1000 mg once daily by mouth for 9 months"
211854|NCT01334125|P2|Participant Flow|Placebo|"1 capsule once daily by mouth for 9 months
Placebo: 1 capsule once daily by mouth for 9 months"
211855|NCT01334125|P1|Participant Flow|Metformin|"Metformin 1000 mg once daily by mouth for 9 months
Metformin: Metformin 1000 mg once daily by mouth for 9 months"
211856|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months
Placebo: 1 capsule once daily by mouth for 9 months"
211857|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months
Metformin: Metformin 1000 mg once daily by mouth for 9 months"
211858|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months
Placebo: 1 capsule once daily by mouth for 9 months"
211859|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months
Metformin: Metformin 1000 mg once daily by mouth for 9 months"
211860|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months
Placebo: 1 capsule once daily by mouth for 9 months"
211861|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months
Metformin: Metformin 1000 mg once daily by mouth for 9 months"
211862|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months
Placebo: 1 capsules once daily by mouth for 9 months"
211863|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months
Metformin: Metformin 1000 mg once daily by mouth for 9 months"
211864|NCT01334125|E2|Reported Event|Placebo|"1 capsule once daily by mouth for 9 months
Placebo: 1 capsule once daily by mouth for 9 months"
211865|NCT01334125|E1|Reported Event|Metformin|"Metformin 1000 mg once daily by mouth for 9 months
Metformin: Metformin 1000 mg once daily by mouth for 9 months"
211866|NCT01333956|B5|Baseline|Total|Total of all reporting groups
211867|NCT01333956|B4|Baseline|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211868|NCT01333956|B3|Baseline|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211869|NCT01333956|B2|Baseline|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211870|NCT01333956|B1|Baseline|Control|"Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211871|NCT01333956|P4|Participant Flow|150mg Arm|Patients will receive 150mg of pregabalin per dose.
211872|NCT01333956|P3|Participant Flow|100mg Arm|Patients will receive 100mg of pregabalin per dose.
211873|NCT01333956|P2|Participant Flow|50mg Arm|Patients will receive 50mg of pregabalin per dose.
211874|NCT01333956|P1|Participant Flow|Control|"Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose."
211875|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
212719|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
211876|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211877|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211878|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211879|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211880|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211881|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211882|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211883|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211884|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211885|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211886|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211887|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211888|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211889|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211890|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211891|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211892|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211893|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211894|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211935|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
211895|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211896|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211897|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211898|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211899|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211900|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211901|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211902|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16."
211903|NCT01333956|E4|Reported Event|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211904|NCT01333956|E3|Reported Event|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211905|NCT01333956|E2|Reported Event|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211906|NCT01333956|E1|Reported Event|Control|"Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
211907|NCT01333865|B1|Baseline|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.
During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
211908|NCT01333865|P1|Participant Flow|Memantine (Namenda) Treatment|"Memantine: Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.
During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
211909|NCT01333865|O1|Outcome|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.
During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
211936|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
211910|NCT01333865|O1|Outcome|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.
During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
211911|NCT01333865|E1|Reported Event|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.
During the 12 weeks of study duration, subjects were be evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
211912|NCT01333813|B1|Baseline|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211913|NCT01333813|P1|Participant Flow|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211914|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211915|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211916|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211917|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211918|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211919|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211920|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211921|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211922|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211923|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211924|NCT01333813|E1|Reported Event|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
211925|NCT01333722|B3|Baseline|Total|Total of all reporting groups
211926|NCT01333722|B2|Baseline|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
211927|NCT01333722|B1|Baseline|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
211928|NCT01333722|P2|Participant Flow|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
211929|NCT01333722|P1|Participant Flow|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
211930|NCT01333722|O2|Outcome|Placebo|placebo, 1 oral tablet every 12 hours
211931|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours
211932|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
211933|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
211934|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
211937|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
211938|NCT01333722|E2|Reported Event|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
211939|NCT01333722|E1|Reported Event|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
211940|NCT01333592|B3|Baseline|Total|Total of all reporting groups
211941|NCT01333592|B2|Baseline|KAD-1229 / Biguanides|
211942|NCT01333592|B1|Baseline|KAD-1229 / DPP-4 Inhibitors|
211943|NCT01333592|P2|Participant Flow|KAD-1229 / Biguanides|
211944|NCT01333592|P1|Participant Flow|KAD-1229 / DPP-4 Inhibitors|
211945|NCT01333592|O2|Outcome|KAD-1229 / Biguanides|
211946|NCT01333592|O1|Outcome|KAD-1229 / DPP-4 Inhibitors|
211947|NCT01333592|O2|Outcome|KAD-1229 / Biguanides|
211948|NCT01333592|O1|Outcome|KAD-1229 / DPP-4 Inhibitors|
211949|NCT01333592|E2|Reported Event|KAD-1229 / Biguanides|
211950|NCT01333592|E1|Reported Event|KAD-1229 / DPP-4 Inhibitors|
211951|NCT01333501|B3|Baseline|Total|Total of all reporting groups
211952|NCT01333501|B2|Baseline|Interferon Beta 1b|250 μg injected s.c. every other day
211953|NCT01333501|B1|Baseline|Fingolimod|0.5 mg in capsules for oral administration once daily
211954|NCT01333501|P2|Participant Flow|Interferon Beta 1b|250 μg injected s.c. every other day
211955|NCT01333501|P1|Participant Flow|Fingolimod|0.5 mg in capsules for oral administration once daily
211956|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211957|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211958|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211959|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211960|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211961|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211962|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211963|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211964|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211965|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211966|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211967|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211968|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211969|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211970|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211971|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211972|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211973|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211974|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211975|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211976|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211977|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211978|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211979|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211980|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211981|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211982|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211983|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211984|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211985|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211986|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211987|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211988|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211989|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211990|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211991|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211992|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211993|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211994|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211995|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211996|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
211997|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
211998|NCT01333501|E2|Reported Event|Interferon Beta 1b|250 μg injected s.c. every other day
211999|NCT01333501|E1|Reported Event|Fingolimod 0.5 mg|0.5 mg in capsules for oral administration once daily
212000|NCT01333488|B4|Baseline|Total|Total of all reporting groups
212001|NCT01333488|B3|Baseline|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
212720|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212002|NCT01333488|B2|Baseline|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
212003|NCT01333488|B1|Baseline|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
212004|NCT01333488|P3|Participant Flow|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
212005|NCT01333488|P2|Participant Flow|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
212006|NCT01333488|P1|Participant Flow|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
212007|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
212008|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
212009|NCT01333488|O1|Outcome|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
212010|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
212011|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
212012|NCT01333488|O1|Outcome|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
212013|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
212014|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
212015|NCT01333488|O1|Outcome|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
212016|NCT01333488|E3|Reported Event|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
212017|NCT01333488|E2|Reported Event|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
212018|NCT01333488|E1|Reported Event|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
212019|NCT01333475|B3|Baseline|Total|Total of all reporting groups
212020|NCT01333475|B2|Baseline|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
212021|NCT01333475|B1|Baseline|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
212022|NCT01333475|P2|Participant Flow|TAC1A|"Cycle = 28 days:MK-2206:135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
212023|NCT01333475|P1|Participant Flow|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
212024|NCT01333475|O2|Outcome|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
212612|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212025|NCT01333475|O1|Outcome|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
212026|NCT01333475|O2|Outcome|TAC1A|"Cycle = 28 days:MK-2206: 135mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
212027|NCT01333475|O1|Outcome|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
212028|NCT01333475|E2|Reported Event|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
212029|NCT01333475|E1|Reported Event|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
212030|NCT01333436|B3|Baseline|Total|Total of all reporting groups
212031|NCT01333436|B2|Baseline|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal ( 57% fat, 31% carbohydrate, and 12% protein).
212032|NCT01333436|B1|Baseline|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein.
212033|NCT01333436|P2|Participant Flow|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
212034|NCT01333436|P1|Participant Flow|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
212035|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
212036|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
212037|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
212038|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
212039|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
212040|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
212041|NCT01333436|E2|Reported Event|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
212042|NCT01333436|E1|Reported Event|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
212043|NCT01333397|B6|Baseline|Total|Total of all reporting groups
212044|NCT01333397|B5|Baseline|Dysport 50 U|Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212045|NCT01333397|B4|Baseline|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212046|NCT01333397|B3|Baseline|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212047|NCT01333397|B2|Baseline|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212048|NCT01333397|B1|Baseline|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212049|NCT01333397|P5|Participant Flow|Dysport 50 U|Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212050|NCT01333397|P4|Participant Flow|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212051|NCT01333397|P3|Participant Flow|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212052|NCT01333397|P2|Participant Flow|Dysport NG 20 U|"Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
Ready to Use (RU)"
212053|NCT01333397|P1|Participant Flow|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212054|NCT01333397|O2|Outcome|Dysport 50 U|
212055|NCT01333397|O1|Outcome|Placebo|
212056|NCT01333397|O4|Outcome|Dysport 50 U|
212057|NCT01333397|O3|Outcome|Dysport NG 75 U|
212058|NCT01333397|O2|Outcome|Dysport NG 50 U|
212059|NCT01333397|O1|Outcome|Dysport NG 20 U|
212060|NCT01333397|O4|Outcome|Dysport 50 U|
212061|NCT01333397|O3|Outcome|Dysport NG 75 U|
212062|NCT01333397|O2|Outcome|Dysport NG 50 U|
212063|NCT01333397|O1|Outcome|Dysport NG 20 U|
212064|NCT01333397|O4|Outcome|Dysport 50 U|
212065|NCT01333397|O3|Outcome|Dysport NG 75 U|
212066|NCT01333397|O2|Outcome|Dysport NG 50 U|
212067|NCT01333397|O1|Outcome|Dysport NG 20 U|
212068|NCT01333397|O5|Outcome|Dysport 50 U|
212069|NCT01333397|O4|Outcome|Dysport NG 75 U|
212070|NCT01333397|O3|Outcome|Dysport NG 50 U|
212071|NCT01333397|O2|Outcome|Dysport NG 20 U|
212072|NCT01333397|O1|Outcome|Placebo|
212073|NCT01333397|O5|Outcome|Dysport 50 U|
212074|NCT01333397|O4|Outcome|Dysport NG 75 U|
212075|NCT01333397|O3|Outcome|Dysport NG 50 U|
212076|NCT01333397|O2|Outcome|Dysport NG 20 U|
212077|NCT01333397|O1|Outcome|Placebo|
212078|NCT01333397|O5|Outcome|Dysport 50 U|
212079|NCT01333397|O4|Outcome|Dysport NG 75 U|
212080|NCT01333397|O3|Outcome|Dysport NG 50 U|
212081|NCT01333397|O2|Outcome|Dysport NG 20 U|
212082|NCT01333397|O1|Outcome|Placebo|
212083|NCT01333397|O5|Outcome|Dysport 50 U|
212084|NCT01333397|O4|Outcome|Dysport NG 75 U|
212085|NCT01333397|O3|Outcome|Dysport NG 50 U|
212086|NCT01333397|O2|Outcome|Dysport NG 20 U|
212087|NCT01333397|O1|Outcome|Placebo|
212088|NCT01333397|O5|Outcome|Dysport 50 U|
212089|NCT01333397|O4|Outcome|Dysport NG 75 U|
212090|NCT01333397|O3|Outcome|Dysport NG 50 U|
212091|NCT01333397|O2|Outcome|Dysport NG 20 U|
212092|NCT01333397|O1|Outcome|Placebo|
212093|NCT01333397|O4|Outcome|Dysport NG 75 U|
212094|NCT01333397|O3|Outcome|Dysport NG 50 U|
212095|NCT01333397|O2|Outcome|Dysport NG 20 U|
212096|NCT01333397|O1|Outcome|Placebo|
212097|NCT01333397|O5|Outcome|Dysport 50 U|
212098|NCT01333397|O4|Outcome|Dysport NG 75 U|
212099|NCT01333397|O3|Outcome|Dysport NG 50 U|
212100|NCT01333397|O2|Outcome|Dysport NG 20 U|
212101|NCT01333397|O1|Outcome|Placebo|
212102|NCT01333397|O4|Outcome|Dysport NG 75 U|
212103|NCT01333397|O3|Outcome|Dysport NG 50 U|
212104|NCT01333397|O2|Outcome|Dysport NG 20 U|
212105|NCT01333397|O1|Outcome|Placebo|
212106|NCT01333397|O4|Outcome|Dysport NG 75 U|
212107|NCT01333397|O3|Outcome|Dysport NG 50 U|
212108|NCT01333397|O2|Outcome|Dysport NG 20 U|
212109|NCT01333397|O1|Outcome|Placebo|
212110|NCT01333397|O5|Outcome|Dysport 50 U|
212111|NCT01333397|O4|Outcome|Dysport NG 75 U|
212112|NCT01333397|O3|Outcome|Dysport NG 50 U|
212113|NCT01333397|O2|Outcome|Dysport NG 20 U|
212114|NCT01333397|O1|Outcome|Placebo|
212115|NCT01333397|O4|Outcome|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212116|NCT01333397|O3|Outcome|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212667|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212117|NCT01333397|O2|Outcome|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212118|NCT01333397|O1|Outcome|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212119|NCT01333397|E5|Reported Event|Dysport 50 U|Botulinum type A toxin ((Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212120|NCT01333397|E4|Reported Event|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212121|NCT01333397|E3|Reported Event|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212122|NCT01333397|E2|Reported Event|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212123|NCT01333397|E1|Reported Event|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
212124|NCT01333189|B3|Baseline|Total|Total of all reporting groups
212125|NCT01333189|B2|Baseline|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212126|NCT01333189|B1|Baseline|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212127|NCT01333189|P2|Participant Flow|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212128|NCT01333189|P1|Participant Flow|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212129|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212130|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212131|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212132|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212133|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212134|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212135|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212136|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212137|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212138|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212139|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212140|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212141|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212142|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212143|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212144|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212145|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212146|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212147|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212158|NCT01333111|B1|Baseline|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212668|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212148|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212149|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212150|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212151|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212152|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212153|NCT01333189|E2|Reported Event|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
212154|NCT01333189|E1|Reported Event|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
212155|NCT01333111|B4|Baseline|Total|Total of all reporting groups
212156|NCT01333111|B3|Baseline|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212157|NCT01333111|B2|Baseline|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212159|NCT01333111|P3|Participant Flow|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212160|NCT01333111|P2|Participant Flow|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212161|NCT01333111|P1|Participant Flow|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212162|NCT01333111|O1|Outcome|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212163|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212164|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212165|NCT01333111|O1|Outcome|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212166|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212167|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212168|NCT01333111|O1|Outcome|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212169|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212170|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212171|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212172|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212173|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212174|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212175|NCT01333111|O1|Outcome|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212176|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212177|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212178|NCT01333111|O1|Outcome|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212179|NCT01333111|O2|Outcome|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212180|NCT01333111|O1|Outcome|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212181|NCT01333111|E3|Reported Event|On-Demand (28 Weeks)|Subjects enrolled in this on-demand arm were treated for bleeding episodes on demand with nonacog beta pegol during a period of 28 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212182|NCT01333111|E2|Reported Event|Prophylaxis, High Dose 40 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 40 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212183|NCT01333111|E1|Reported Event|Prophylaxis, Low Dose 10 U/kg (52 Weeks)|Subjects were randomised to either prophylaxis 10 U/kg or 40 U/kg arm. Subjects in this arm received 10 U/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours) for a period of 52 weeks. Nonacog beta pegol was given as an intravenous bolus injection with the maximum injection rate at 4 mL/min. Mild and moderate bleeding episodes were treated with 40 U/kg. Severe bleeding episodes were treated with 80 U/kg.
212184|NCT01332994|B1|Baseline|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212185|NCT01332994|P1|Participant Flow|Tocilizumab (TCZ)/TCZ or TCZ/Rituximab (RTX)|All participants were assigned to receive TCZ 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using Disease Activity Score Based on 28-Joint Count (DAS28) to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of less than (<) 2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score greater than (>) 1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score less than or equal to (≤) 1.2 or a score >3.2, received RTX 1000 milligrams (mg) via IV infusion at Weeks 16 and 18.
212186|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212187|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212721|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212188|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212189|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212190|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212191|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212192|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212193|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212194|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212195|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212253|NCT01332968|B1|Baseline|Rituximab+Chemotherapy - Induction Period|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212254|NCT01332968|P8|Participant Flow|Obinutuzumab+Chemotherapy - Follow-Up Period|Finally, participants were followed during a 5-year follow-up period.
212196|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212197|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212198|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212199|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212200|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212201|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212202|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212203|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212255|NCT01332968|P7|Participant Flow|Rituximab+Chemotherapy - Follow-Up Period|Finally, participants were followed during a 5-year follow-up period.
212256|NCT01332968|P6|Participant Flow|Obinutuzumab+Chemotherapy - Observation Period|Obinutuzumab+Chemotherapy – Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.
212669|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212204|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212205|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212206|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212207|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212208|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212209|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212210|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212211|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212257|NCT01332968|P5|Participant Flow|Rituximab+Chemotherapy - Observation Period|Rituximab+Chemotherapy – Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.
212258|NCT01332968|P4|Participant Flow|Obinutuzumab+Chemotherapy - Maintenance Period|The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period.
212212|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212213|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212214|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212215|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212216|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212217|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212218|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212219|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212259|NCT01332968|P3|Participant Flow|Rituximab+Chemotherapy - Maintenance Period|The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period.
212404|NCT01332435|P4|Participant Flow|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212220|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212221|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212222|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212223|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212224|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212225|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212226|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212227|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212260|NCT01332968|P2|Participant Flow|Obinutuzumab+Chemotherapy - Induction Period|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212670|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212228|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212229|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212230|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212231|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212232|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212233|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212234|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212235|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212261|NCT01332968|P1|Participant Flow|Rituximab+Chemotherapy - Induction Period|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212722|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212236|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212237|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212238|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212239|NCT01332994|E1|Reported Event|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
212240|NCT01332981|B1|Baseline|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
212241|NCT01332981|P1|Participant Flow|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
212242|NCT01332981|O2|Outcome|Model 2|In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%.
212243|NCT01332981|O1|Outcome|Model 1|In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters.
212244|NCT01332981|O2|Outcome|Model 2|In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%.
212245|NCT01332981|O1|Outcome|Model 1|In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters.
212246|NCT01332981|O1|Outcome|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
212247|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
212248|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
212249|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
212250|NCT01332981|E1|Reported Event|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
212251|NCT01332968|B3|Baseline|Total|Total of all reporting groups
212252|NCT01332968|B2|Baseline|Obinutuzumab+Chemotherapy - Induction Period|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212262|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212263|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212264|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212265|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212266|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212267|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212268|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212269|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212399|NCT01332435|B5|Baseline|Total|Total of all reporting groups
212603|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212270|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212271|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212272|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212273|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212274|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212275|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
212276|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212277|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212400|NCT01332435|B4|Baseline|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212278|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212279|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212280|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212281|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212282|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212283|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212284|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212285|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212604|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212286|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212287|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212288|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212289|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212290|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212291|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212292|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212293|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212605|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212294|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212295|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212296|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212297|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212298|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212299|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212300|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212301|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212606|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212302|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212303|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212304|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212305|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212306|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212307|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212308|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212309|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212607|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212310|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212311|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212312|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212313|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212314|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212315|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212316|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212317|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212608|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212318|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212319|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212320|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212321|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212322|NCT01332968|E2|Reported Event|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212323|NCT01332968|E1|Reported Event|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
212324|NCT01332721|B1|Baseline|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
212325|NCT01332721|P1|Participant Flow|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
212326|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
215469|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
212327|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
212328|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
212329|NCT01332721|E1|Reported Event|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
212330|NCT01332578|B1|Baseline|All Randomized Participants|All randomized participants who received a study treatment during the cross over study.
212331|NCT01332578|P2|Participant Flow|Standard Paracetamol Tablets First, Then Hot Drink Remedy|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water (first intervention period). After a washout period of minimum two days, one sachet of hot drink remedy with 150 mL of radio-labeled water was administered (second intervention period).
212332|NCT01332578|P1|Participant Flow|Hot Drink Remedy First, Then Standard Paracetamol Tablets|Participants received one sachet of hot drink remedy containing 1000 milligram (mg) paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid in 150 milliliter (mL) of radio-labeled water (first intervention period). After a washout period of minimum two days, a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL water were administered (second intervention period).
212333|NCT01332578|O1|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
212334|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
212335|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
212336|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
212337|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
212338|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
212339|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
212340|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
212341|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
212342|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
212343|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
212344|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
212345|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
212346|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
212347|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
212348|NCT01332578|E2|Reported Event|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
212349|NCT01332578|E1|Reported Event|Hot Drink Remedy|Participants then received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid, which was dissolved in 150 mL of radio-labeled water.
212350|NCT01332500|B5|Baseline|Total|Total of all reporting groups
212401|NCT01332435|B3|Baseline|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212671|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212351|NCT01332500|B4|Baseline|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212352|NCT01332500|B3|Baseline|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212353|NCT01332500|B2|Baseline|Naïve - Oral Triptan|"Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.
Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics."
212354|NCT01332500|B1|Baseline|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212355|NCT01332500|P4|Participant Flow|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212356|NCT01332500|P3|Participant Flow|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212357|NCT01332500|P2|Participant Flow|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.
212358|NCT01332500|P1|Participant Flow|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212359|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212360|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212402|NCT01332435|B2|Baseline|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212672|NCT01332253|E2|Reported Event|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212361|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212362|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212363|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212364|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212365|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212366|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212367|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212368|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212369|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212370|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212403|NCT01332435|B1|Baseline|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
215470|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
212371|NCT01332500|E4|Reported Event|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212372|NCT01332500|E3|Reported Event|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212373|NCT01332500|E2|Reported Event|Naïve - Oral Triptan|"Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.
Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics."
212374|NCT01332500|E1|Reported Event|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
212375|NCT01332487|B3|Baseline|Total|Total of all reporting groups
212376|NCT01332487|B2|Baseline|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
212377|NCT01332487|B1|Baseline|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
212378|NCT01332487|P2|Participant Flow|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
212379|NCT01332487|P1|Participant Flow|Early Treatment|Participants who started 5-alpha-reductase inhibitor (5ARI) therapy within 30 days of initiating alpha-blocker (AB) treatment
212380|NCT01332487|O2|Outcome|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
212381|NCT01332487|O1|Outcome|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
212382|NCT01332487|O2|Outcome|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
212383|NCT01332487|O1|Outcome|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
212384|NCT01332487|E2|Reported Event|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
212385|NCT01332487|E1|Reported Event|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
212386|NCT01332461|B3|Baseline|Total|Total of all reporting groups
212387|NCT01332461|B2|Baseline|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
212388|NCT01332461|B1|Baseline|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
212389|NCT01332461|P2|Participant Flow|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
212390|NCT01332461|P1|Participant Flow|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
212391|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
212392|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
212393|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
212394|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
212395|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
212396|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
212397|NCT01332461|E2|Reported Event|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
212398|NCT01332461|E1|Reported Event|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
212405|NCT01332435|P3|Participant Flow|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212406|NCT01332435|P2|Participant Flow|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212407|NCT01332435|P1|Participant Flow|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
212408|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212409|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212410|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212411|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
212412|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212413|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212414|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212415|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
212416|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212417|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212418|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212419|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
212420|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212421|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212422|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212423|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
212424|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212425|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212426|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212427|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
212428|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212429|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212430|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212431|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
212432|NCT01332435|E4|Reported Event|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212433|NCT01332435|E3|Reported Event|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212434|NCT01332435|E2|Reported Event|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
212435|NCT01332435|E1|Reported Event|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
212436|NCT01332357|B1|Baseline|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
212437|NCT01332357|P1|Participant Flow|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
212438|NCT01332357|O1|Outcome|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
212439|NCT01332357|E1|Reported Event|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
212440|NCT01332318|B5|Baseline|Total|Total of all reporting groups
212441|NCT01332318|B4|Baseline|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212609|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212442|NCT01332318|B3|Baseline|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212443|NCT01332318|B2|Baseline|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212444|NCT01332318|B1|Baseline|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212445|NCT01332318|P4|Participant Flow|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212446|NCT01332318|P3|Participant Flow|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212447|NCT01332318|P2|Participant Flow|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212448|NCT01332318|P1|Participant Flow|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212449|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212450|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212451|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212452|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212453|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212454|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212455|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212456|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212673|NCT01332253|E1|Reported Event|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212457|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212458|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212459|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212460|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212461|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212462|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212463|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212464|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212465|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212466|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212467|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212468|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212469|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212470|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212471|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212674|NCT01332227|B3|Baseline|Total|Total of all reporting groups
212472|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212473|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212474|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212475|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212476|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212477|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212478|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212479|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212480|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212481|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212482|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212483|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212484|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212485|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212486|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212715|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212487|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212488|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212489|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212490|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212491|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212492|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212493|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212494|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212495|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212496|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212497|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212498|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212499|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212500|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212501|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212502|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
215471|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
212503|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212504|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212505|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212506|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212507|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212508|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212509|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212510|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212511|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212512|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212513|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212514|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212515|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212516|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212517|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212518|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212519|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212520|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212521|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212522|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212523|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212524|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212525|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212526|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212527|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212528|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212529|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212530|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212531|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212532|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212533|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212534|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212535|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212536|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212537|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212538|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212539|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212540|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212541|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212542|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212543|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212544|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212545|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212546|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212547|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212548|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212549|NCT01332318|E4|Reported Event|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212550|NCT01332318|E3|Reported Event|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212551|NCT01332318|E2|Reported Event|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
212552|NCT01332318|E1|Reported Event|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
212553|NCT01332305|B6|Baseline|Total|Total of all reporting groups
212554|NCT01332305|B5|Baseline|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
212555|NCT01332305|B4|Baseline|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
212556|NCT01332305|B3|Baseline|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212557|NCT01332305|B2|Baseline|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212558|NCT01332305|B1|Baseline|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212559|NCT01332305|P5|Participant Flow|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
212560|NCT01332305|P4|Participant Flow|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
212561|NCT01332305|P3|Participant Flow|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212562|NCT01332305|P2|Participant Flow|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212563|NCT01332305|P1|Participant Flow|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212564|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
212565|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
212566|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212610|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212567|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212568|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212569|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
212570|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
212571|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212572|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212573|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212574|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
212575|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
212576|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212577|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212578|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212579|NCT01332305|E5|Reported Event|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
212580|NCT01332305|E4|Reported Event|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
212581|NCT01332305|E3|Reported Event|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212611|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212716|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212582|NCT01332305|E2|Reported Event|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212583|NCT01332305|E1|Reported Event|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
212584|NCT01332292|B1|Baseline|FF 100 µg/Placebo or Placebo/FF 100 µg|Participants received either fluticasone furoate (FF) 100 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled FF 100 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212585|NCT01332292|P2|Participant Flow|Sequence 2: Placebo Followed by FF 100 µg|Participants received placebo in Treatment Period 1 and FF 100 µg in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
212586|NCT01332292|P1|Participant Flow|Sequence 1: FF 100 µg Followed by Placebo|Participants received fluticasone furoate (FF) 100 micrograms (µg) in Treatment Period 1 and matching placebo in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
212587|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212588|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212589|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212590|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212591|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212592|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212593|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212594|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212595|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212596|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212597|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212598|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212599|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212600|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212601|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212602|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212717|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212613|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212614|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212615|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212616|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212617|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212618|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212619|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212620|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212621|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212622|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212623|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212624|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212625|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212626|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212627|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212628|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212629|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212630|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212631|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212632|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212633|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212634|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212635|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212718|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212636|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212637|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212638|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212639|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212640|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212641|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212642|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212643|NCT01332292|E2|Reported Event|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212644|NCT01332292|E1|Reported Event|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
212645|NCT01332253|B3|Baseline|Total|Total of all reporting groups
212646|NCT01332253|B2|Baseline|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212647|NCT01332253|B1|Baseline|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212648|NCT01332253|P2|Participant Flow|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212649|NCT01332253|P1|Participant Flow|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212650|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212651|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212652|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212653|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212654|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212655|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212656|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212657|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212658|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212659|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212660|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212661|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212662|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212663|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212664|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212665|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
212666|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
212675|NCT01332227|B2|Baseline|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
212676|NCT01332227|B1|Baseline|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
212677|NCT01332227|P2|Participant Flow|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
212678|NCT01332227|P1|Participant Flow|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
212679|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
212680|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
212681|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
212682|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
212683|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
212684|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
212685|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
212686|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
212687|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
212688|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
212689|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
212690|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
212691|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
212692|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
212693|NCT01332227|E2|Reported Event|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
212694|NCT01332227|E1|Reported Event|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
212695|NCT01332188|B5|Baseline|Total|Total of all reporting groups
212696|NCT01332188|B4|Baseline|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212697|NCT01332188|B3|Baseline|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212698|NCT01332188|B2|Baseline|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212699|NCT01332188|B1|Baseline|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212700|NCT01332188|P4|Participant Flow|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212701|NCT01332188|P3|Participant Flow|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212702|NCT01332188|P2|Participant Flow|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212703|NCT01332188|P1|Participant Flow|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212704|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212705|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212706|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212707|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212708|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212709|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212710|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212711|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212712|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212713|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212714|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212723|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212724|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212725|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212726|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212727|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212728|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212729|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212730|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212731|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212732|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212733|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212734|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212735|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212736|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212737|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212738|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212739|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212740|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212741|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212742|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212743|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212744|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212745|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212746|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212747|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212748|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212749|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212750|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212751|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212752|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212753|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212754|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212755|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212756|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212757|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212758|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212759|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212760|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212761|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212762|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212763|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212764|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212765|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212766|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212767|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212768|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212769|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212770|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212771|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212772|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212773|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212774|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212775|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212776|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212777|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
215472|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
212778|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212779|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212780|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212781|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212782|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212783|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212784|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212785|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212786|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212787|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212788|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212789|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212790|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212791|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212792|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212793|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212794|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212795|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212796|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212797|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212798|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212799|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212800|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212801|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212802|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212803|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212804|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212805|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212806|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212807|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212808|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212809|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212810|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212811|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212812|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212813|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212814|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212815|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212816|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212817|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212818|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212819|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212820|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212821|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212822|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212823|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212824|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212825|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212826|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212827|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212828|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212829|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212830|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212831|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212832|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
215473|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
212833|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212834|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212835|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212836|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212837|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212838|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212839|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212840|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212841|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212842|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212843|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212844|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212845|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212846|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212847|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212848|NCT01332188|O4|Outcome|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212849|NCT01332188|O3|Outcome|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212850|NCT01332188|O2|Outcome|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212851|NCT01332188|O1|Outcome|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212852|NCT01332188|E4|Reported Event|AC-170 0%|AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
212853|NCT01332188|E3|Reported Event|AC-170 0.24%|AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
212854|NCT01332188|E2|Reported Event|AC-170 0.1%|AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
212855|NCT01332188|E1|Reported Event|AC-170 0.05%|AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
212856|NCT01332149|B3|Baseline|Total|Total of all reporting groups
212857|NCT01332149|B2|Baseline|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212858|NCT01332149|B1|Baseline|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212859|NCT01332149|P2|Participant Flow|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212860|NCT01332149|P1|Participant Flow|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212861|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212862|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212863|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212864|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212865|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212866|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212867|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
215474|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
212868|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212869|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212870|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212871|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212872|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212873|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212874|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212875|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212876|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212877|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212878|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212879|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212880|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212881|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212882|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212883|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212884|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212885|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212923|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
212924|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
212925|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
212886|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212887|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212888|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212889|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212890|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212891|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212892|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212893|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212894|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212895|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212896|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212897|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212898|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212899|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212900|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212901|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212902|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212903|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212926|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
212927|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
212928|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
212904|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212905|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212906|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212907|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212908|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212909|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212910|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212911|NCT01332149|E2|Reported Event|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
212912|NCT01332149|E1|Reported Event|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
212913|NCT01332123|B1|Baseline|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)
Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)"
212914|NCT01332123|P1|Participant Flow|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)
Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)"
212915|NCT01332123|O1|Outcome|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)
Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)"
212916|NCT01332123|O1|Outcome|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)
All participants were subjected to the same 5 interventions (neutral alignment and 4 perturbations as detailed above) in sequence to allow repeated measures (within-subject) comparisons."
212917|NCT01332123|E1|Reported Event|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)
Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)"
212918|NCT01332071|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Avandamet 4 mg + 1000 mg in Period 1; followed by reference product: Avandamet 2 mg + 500 mg in Period 2 or reference product in Period 1 and test product in Period 2
212919|NCT01332071|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2
212920|NCT01332071|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2
212921|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
212922|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
212929|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
212930|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
212931|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
212932|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
212933|NCT01332071|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2
212934|NCT01332071|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2
212935|NCT01332019|B3|Baseline|Total|Total of all reporting groups
212936|NCT01332019|B2|Baseline|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212937|NCT01332019|B1|Baseline|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212938|NCT01332019|P2|Participant Flow|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212939|NCT01332019|P1|Participant Flow|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212940|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212941|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212942|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212943|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212944|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212945|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212946|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212947|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212948|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212949|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212950|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212951|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212952|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212953|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212954|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212955|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212956|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212957|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212958|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212959|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212960|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212961|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212962|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212963|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212964|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212965|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212966|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212967|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212968|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212969|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212970|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212971|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212972|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212973|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212974|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212975|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212976|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212977|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212978|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212979|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212980|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212981|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212982|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212983|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212984|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212985|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212986|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212987|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212988|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212989|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212990|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212991|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212992|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212993|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212994|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212995|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212996|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212997|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
212998|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
212999|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
213000|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
213001|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
213002|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
213003|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
213004|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
213005|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
213006|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
213007|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
213008|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
213009|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
213010|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
213011|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
213012|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
213013|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
213014|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
213015|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
213016|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
213017|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
213018|NCT01332019|E2|Reported Event|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
213019|NCT01332019|E1|Reported Event|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
213020|NCT01331837|B3|Baseline|Total|Total of all reporting groups
213021|NCT01331837|B2|Baseline|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213022|NCT01331837|B1|Baseline|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213023|NCT01331837|P2|Participant Flow|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213024|NCT01331837|P1|Participant Flow|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213025|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213026|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213027|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213028|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
215475|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
213029|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213030|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213031|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213032|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213033|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213034|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213035|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213036|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213037|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213038|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213039|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213040|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213041|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213042|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213043|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213044|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213045|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213046|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213047|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213048|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213049|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213050|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213051|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213052|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213053|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213054|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213055|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213056|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213057|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213058|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213059|NCT01331837|O2|Outcome|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213060|NCT01331837|O1|Outcome|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213061|NCT01331837|E2|Reported Event|Tocilizumab|Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
213062|NCT01331837|E1|Reported Event|Etanercept|Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
213063|NCT01331824|B1|Baseline|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
213064|NCT01331824|P1|Participant Flow|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
213065|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
213066|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
213067|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
213068|NCT01331824|E1|Reported Event|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
213069|NCT01331694|B7|Baseline|Total|Total of all reporting groups
213070|NCT01331694|B6|Baseline|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
213071|NCT01331694|B5|Baseline|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
213072|NCT01331694|B4|Baseline|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
213073|NCT01331694|B3|Baseline|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
213074|NCT01331694|B2|Baseline|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
213075|NCT01331694|B1|Baseline|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
213076|NCT01331694|P6|Participant Flow|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
213077|NCT01331694|P5|Participant Flow|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
213078|NCT01331694|P4|Participant Flow|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
213079|NCT01331694|P3|Participant Flow|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
213080|NCT01331694|P2|Participant Flow|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
213081|NCT01331694|P1|Participant Flow|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 micrograms (mcg)/50 mcg
213082|NCT01331694|O3|Outcome|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
213083|NCT01331694|O2|Outcome|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
213084|NCT01331694|O1|Outcome|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
213085|NCT01331694|O3|Outcome|Risk Population TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
213086|NCT01331694|O2|Outcome|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
213087|NCT01331694|O1|Outcome|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
213088|NCT01331694|E6|Reported Event|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
213089|NCT01331694|E5|Reported Event|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
213090|NCT01331694|E4|Reported Event|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
213091|NCT01331694|E3|Reported Event|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
213092|NCT01331694|E2|Reported Event|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
213093|NCT01331694|E1|Reported Event|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
213094|NCT01331681|B4|Baseline|Total|Total of all reporting groups
213095|NCT01331681|B3|Baseline|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
213096|NCT01331681|B2|Baseline|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
213097|NCT01331681|B1|Baseline|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
213098|NCT01331681|P3|Participant Flow|Macular Laser Photocoagulation (Control)|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
213099|NCT01331681|P2|Participant Flow|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
213100|NCT01331681|P1|Participant Flow|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
213101|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
213102|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
213103|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
213104|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
213105|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
213106|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
213107|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
213108|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
213109|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
213110|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
213111|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
213112|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
213113|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
213114|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
213115|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
213116|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
213117|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
213118|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
213119|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
213120|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
213121|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
213122|NCT01331681|E3|Reported Event|Macular Laser Photocoagulation (Control)|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. During year 3 laser patients could receive IAI as needed (PRN) .
213123|NCT01331681|E2|Reported Event|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
213124|NCT01331681|E1|Reported Event|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
213125|NCT01331304|B3|Baseline|Total|Total of all reporting groups
213126|NCT01331304|B2|Baseline|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.
Quetiapine: 100-800mg a day over 6 months"
213127|NCT01331304|B1|Baseline|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.
Lithium: 600-1200mg per day over 6 months"
213128|NCT01331304|P2|Participant Flow|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.
Quetiapine: 100-800mg a day over 6 months"
213129|NCT01331304|P1|Participant Flow|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.
Lithium: 600-1200mg per day over 6 months"
213130|NCT01331304|O2|Outcome|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.
Quetiapine: 100-800mg a day over 6 months"
213131|NCT01331304|O1|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.
Lithium: 600-1200mg per day over 6 months"
213132|NCT01331304|O2|Outcome|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.
Quetiapine: 100-800mg a day over 6 months"
213133|NCT01331304|O1|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.
Lithium: 600-1200mg per day over 6 months"
213134|NCT01331304|E2|Reported Event|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.
Quetiapine: 100-800mg a day over 6 months"
213135|NCT01331304|E1|Reported Event|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.
Lithium: 600-1200mg per day over 6 months"
213136|NCT01331291|B3|Baseline|Total|Total of all reporting groups
213137|NCT01331291|B2|Baseline|Arm B|"Patients that are not surgical candidates
bosutinib: Taken orally"
213138|NCT01331291|B1|Baseline|Arm A|"Patients who are surgical candidates
bosutinib: Taken orally"
213139|NCT01331291|P2|Participant Flow|Arm B|"Patients that are not surgical candidates
bosutinib: Taken orally"
213140|NCT01331291|P1|Participant Flow|Arm A|"Patients who are surgical candidates
bosutinib: Taken orally"
213141|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates
bosutinib: Taken orally"
213142|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates
bosutinib: Taken orally"
213143|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates
bosutinib: Taken orally"
213144|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates
bosutinib: Taken orally"
213145|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates
bosutinib: Taken orally"
213146|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates
bosutinib: Taken orally"
213147|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates
bosutinib: Taken orally"
213148|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates
bosutinib: Taken orally"
213149|NCT01331291|E1|Reported Event|Combined Arms|Adverse Events were measured across all participants, regardless of arm.
213150|NCT01331213|B3|Baseline|Total|Total of all reporting groups
213151|NCT01331213|B2|Baseline|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
213152|NCT01331213|B1|Baseline|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
213153|NCT01331213|P2|Participant Flow|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
213154|NCT01331213|P1|Participant Flow|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
213155|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
213156|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
213157|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
213158|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
213159|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
213160|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
213161|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
213162|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
213163|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
213164|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
213165|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
213166|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
213167|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
213168|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
213169|NCT01331213|E2|Reported Event|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
213170|NCT01331213|E1|Reported Event|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
213171|NCT01331161|B3|Baseline|Total|Total of all reporting groups
213172|NCT01331161|B2|Baseline|Age 25-40 Years|Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
213173|NCT01331161|B1|Baseline|Age 60-79 Years|Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
213174|NCT01331161|P2|Participant Flow|Younger Group|"Participants between the ages of 25-40
ZOSTAVAX: shingles vaccine, one dose"
213175|NCT01331161|P1|Participant Flow|Older Group|"Participants between the ages of 60-79
ZOSTAVAX: shingles vaccine, one dose"
213176|NCT01331161|O2|Outcome|Age 25-40 Years|Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
213177|NCT01331161|O1|Outcome|Age 60-79 Years|Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
213178|NCT01331161|O2|Outcome|Participants 25-40 Years of Age|participants with one dose of vaccine
213179|NCT01331161|O1|Outcome|Participants 60-79 Years|participants who received one dose of vaccine
213180|NCT01331161|E2|Reported Event|Younger Group|"Participants between the ages of 25-40
ZOSTAVAX: shingles vaccine, one dose"
213181|NCT01331161|E1|Reported Event|Older Group|"Participants between the ages of 60-79
ZOSTAVAX: shingles vaccine, one dose"
213182|NCT01331109|B1|Baseline|Milnacipran|"oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
213262|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
213183|NCT01331109|P1|Participant Flow|Milnacipran|"oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
213184|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
213185|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
213186|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
213187|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
213188|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
213189|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
213190|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
213191|NCT01331109|E1|Reported Event|Milnacipran|"oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
213192|NCT01331005|B3|Baseline|Total|Total of all reporting groups
213193|NCT01331005|B2|Baseline|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year
nepafenac 0.1% drops: One drop three times per day for one year"
213194|NCT01331005|B1|Baseline|Placebo|"Placebo will be given three times per day for one year
Nepafenac Vehicle: Placebo"
213195|NCT01331005|P2|Participant Flow|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year
nepafenac 0.1% drops: One drop three times per day for one year"
213196|NCT01331005|P1|Participant Flow|Placebo|"Placebo will be given three times per day for one year
Nepafenac Vehicle: Placebo"
213197|NCT01331005|O2|Outcome|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year
nepafenac 0.1% drops: One drop three times per day for one year"
213198|NCT01331005|O1|Outcome|Placebo|"Placebo will be given three times per day for one year
Nepafenac Vehicle: Placebo"
213199|NCT01331005|E2|Reported Event|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year
nepafenac 0.1% drops: One drop three times per day for one year"
213200|NCT01331005|E1|Reported Event|Placebo|"Placebo will be given three times per day for one year
Nepafenac Vehicle: Placebo"
213201|NCT01330914|B1|Baseline|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
213202|NCT01330914|P1|Participant Flow|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
213203|NCT01330914|O1|Outcome|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
213204|NCT01330914|E1|Reported Event|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
213205|NCT01330628|B3|Baseline|Total|Total of all reporting groups
213206|NCT01330628|B2|Baseline|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
213207|NCT01330628|B1|Baseline|Laser Atherectomy and PTA|"laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
213208|NCT01330628|P2|Participant Flow|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
213209|NCT01330628|P1|Participant Flow|Laser Atherectomy and PTA|"laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
213210|NCT01330628|O2|Outcome|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
213211|NCT01330628|O1|Outcome|Laser Atherectomy and PTA|"laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
213212|NCT01330628|O2|Outcome|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
213213|NCT01330628|O1|Outcome|Laser Atherectomy and PTA|"laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
213214|NCT01330628|E2|Reported Event|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
213215|NCT01330628|E1|Reported Event|Laser Atherectomy and PTA|"laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
213216|NCT01330433|B3|Baseline|Total|Total of all reporting groups
213217|NCT01330433|B2|Baseline|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal"
213218|NCT01330433|B1|Baseline|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
213219|NCT01330433|P2|Participant Flow|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal"
213220|NCT01330433|P1|Participant Flow|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
213263|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213264|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
213221|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal"
213222|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
213223|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal"
213224|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
213225|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal"
213226|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
213227|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal"
213228|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
213229|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal"
213230|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
213231|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal"
213232|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
213233|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal"
213234|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
213235|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal"
213236|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
213237|NCT01330433|E2|Reported Event|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal"
213238|NCT01330433|E1|Reported Event|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
213239|NCT01330420|B1|Baseline|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session, 1.5 hour, mind body intervention.
The 3RP-D was designed to promote resiliency by reducing the harmful effects of stress through the elicitation of the relaxation response, and through skill training to enhance positive attitudes and beliefs, nutrition, exercise, recuperative sleep, social support, and coping. Specific interventions include: cognitive behavioral therapy (CBT), enhancing social support (SS), cultivating positive attitudes and beliefs (CPE), and promoting Healthy Lifestyle Habits(HL). The 3RP-D program has been manualized for use by group facilitators and health center patients."
213328|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213240|NCT01330420|P1|Participant Flow|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)
The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
213241|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)
The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
213242|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)
The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
213243|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)
The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
213244|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)
The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
213245|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)
The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
213246|NCT01330420|E1|Reported Event|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session, 1.5 hour, mind body intervention.
The 3RP-D was designed to promote resiliency by reducing the harmful effects of stress through the elicitation of the relaxation response, and through skill training to enhance positive attitudes and beliefs, nutrition, exercise, recuperative sleep, social support, and coping. Specific interventions include: cognitive behavioral therapy (CBT), enhancing social support (SS), cultivating positive attitudes and beliefs (CPE), and promoting Healthy Lifestyle Habits(HL). The 3RP-D program has been manualized for use by group facilitators and health center patients."
213247|NCT01330394|B3|Baseline|Total|Total of all reporting groups
213248|NCT01330394|B2|Baseline|Active tDCS|active transcranial Direct Current Stimulation
213249|NCT01330394|B1|Baseline|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
213250|NCT01330394|P2|Participant Flow|Active tDCS|active transcranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 2 mA, double 13 min stimulation with 20 min interval between them) was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex once a day for 5 consecutive days
213251|NCT01330394|P1|Participant Flow|Sham-tDCS Control|simulate control for bilateral transcranial Direct Current Stimulation on the left and right dorsolateral prefrontal cortex
213252|NCT01330394|O2|Outcome|Active tDCS|active transcranial Direct Current Stimulation
213253|NCT01330394|O1|Outcome|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
213254|NCT01330394|E2|Reported Event|Active tDCS|active transcranial Direct Current Stimulation
213255|NCT01330394|E1|Reported Event|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
213256|NCT01330381|B3|Baseline|Total|Total of all reporting groups
213257|NCT01330381|B2|Baseline|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213258|NCT01330381|B1|Baseline|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213259|NCT01330381|P3|Participant Flow|PEG 4000 (Polyethylene Glycol)|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
213260|NCT01330381|P2|Participant Flow|Placebo|"Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution.
Subjects with weight >50 kg received placebo matching prucalopride oral tablet."
213261|NCT01330381|P1|Participant Flow|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213265|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213266|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213267|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213268|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
213269|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213270|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213271|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213272|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213273|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213274|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213275|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213276|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213277|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213278|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213279|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213280|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213281|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213282|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213283|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213284|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213285|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213286|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213287|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213288|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213289|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213290|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213291|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213292|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213293|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213294|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213295|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213296|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213365|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both periods
213297|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213298|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213299|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213300|NCT01330381|E4|Reported Event|PEG 4000 (Open-label Period)|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
213301|NCT01330381|E3|Reported Event|Prucalopride (Open-label Period)|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213302|NCT01330381|E2|Reported Event|Placebo (Double-blind Period)|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
213303|NCT01330381|E1|Reported Event|Prucalopride (Double-blind Period)|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
213304|NCT01330355|B3|Baseline|Total|Total of all reporting groups
213305|NCT01330355|B2|Baseline|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
213306|NCT01330355|B1|Baseline|Besivance|"Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
213307|NCT01330355|P2|Participant Flow|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
213308|NCT01330355|P1|Participant Flow|Besivance|"Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
213309|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
213310|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
213311|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
213312|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
213313|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
213314|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
213315|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
213316|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
213317|NCT01330355|E2|Reported Event|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
213318|NCT01330355|E1|Reported Event|Besivance|"Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
213319|NCT01330316|B3|Baseline|Total|Total of all reporting groups
213320|NCT01330316|B2|Baseline|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213321|NCT01330316|B1|Baseline|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213322|NCT01330316|P2|Participant Flow|Non-relapse|"Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients.
Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10 decrease in HCV RNA from baseline during the treatment period.
Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA.
Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment."
213323|NCT01330316|P1|Participant Flow|Relapse|"Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients.
At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV.
ETS is defined as Hepatitis C virus(HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8.
Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser."
213324|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213325|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213326|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213327|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213329|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213330|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213331|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213332|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213333|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213334|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213335|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213336|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213337|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213338|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213339|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213340|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213341|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213342|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213343|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213344|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213345|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213346|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213347|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213348|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213349|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213350|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213351|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213352|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213353|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213354|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213355|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213356|NCT01330316|E2|Reported Event|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
213357|NCT01330316|E1|Reported Event|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
213358|NCT01330303|B1|Baseline|Participants Receiving Both Test Product and Reference Product|Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2 or reference product in Period 1 and test product in Period 2
213359|NCT01330303|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2
213360|NCT01330303|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2
213361|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both period
213362|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
213363|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both period
213364|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
213366|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
213367|NCT01330303|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2
213368|NCT01330303|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2
213369|NCT01330290|B1|Baseline|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213370|NCT01330290|P1|Participant Flow|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213371|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213372|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213373|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213374|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213375|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213376|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213377|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213378|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213379|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213394|NCT01330108|P1|Participant Flow|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.
ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
213410|NCT01330030|B2|Baseline|Matching Placebo|"matching placebo worn 24 hours for 8 weeks
matching placebo: placebo/24hrs for 8 weeks"
213380|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213381|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213382|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213383|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213384|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213385|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213386|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213387|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213388|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213389|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213390|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213391|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213392|NCT01330290|E1|Reported Event|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
213393|NCT01330108|B1|Baseline|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.
ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
213395|NCT01330108|O1|Outcome|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.
ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
213396|NCT01330108|O1|Outcome|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.
ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
213397|NCT01330108|E1|Reported Event|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.
ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
213398|NCT01330043|B3|Baseline|Total|Total of all reporting groups
213399|NCT01330043|B2|Baseline|Extended Treatment|Participants receive 52 weeks of cognitive behavioral therapy (maintenance plus extended treatment). Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
213400|NCT01330043|B1|Baseline|Maintenance Treatment|Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 26.
213401|NCT01330043|P2|Participant Flow|Extended Treatment|Participants will receive twelve months (52 weeks) of cognitive behavioral therapy.
213402|NCT01330043|P1|Participant Flow|Maintenance Therapy|Participants will receive six months (26 weeks) of cognitive behavioral therapy (maintenance treatment) and a monthly phone call after 26 weeks asking about their smoking status and will not receive any treatment.
213403|NCT01330043|O2|Outcome|Extended Treatment|Participants receive 52 weeks of cognitive behavioral therapy (extended treatment). During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
213404|NCT01330043|O1|Outcome|Maintenance Treatment|Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
213405|NCT01330043|O2|Outcome|Extended Treatment|Participants receive 52 weeks of cognitive behavioral therapy (extended treatment). During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
213406|NCT01330043|O1|Outcome|Maintenance Treatment|Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52.
213407|NCT01330043|E2|Reported Event|Extended Treatment|"Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by another 26 weeks of cognitive behavioral therapy (extended treatment). Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26.
Maintenance treatment (cognitive behavioral therapy)(CBT): During open label treatment, all receive CBT and bupropion and NRT patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of cravin"
213408|NCT01330043|E1|Reported Event|Maintenance Treatment|"Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26.
Maintenance treatment (cognitive behavioral therapy)(CBT): During open label treatment, all receive CBT and bupropion and NRT patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 1"
213409|NCT01330030|B3|Baseline|Total|Total of all reporting groups
213411|NCT01330030|B1|Baseline|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks
Selegiline: 6mg/24 hrs for 8 weeks"
213412|NCT01330030|P2|Participant Flow|Matching Placebo|matching placebo worn 24 hours for 8 weeks
213413|NCT01330030|P1|Participant Flow|Drug Selegiline|6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks
213414|NCT01330030|O2|Outcome|Matching Placebo|"matching placebo worn 24 hours for 8 weeks
matching placebo: placebo/24hrs for 8 weeks"
213415|NCT01330030|O1|Outcome|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks
Selegiline: 6mg/24 hrs for 8 weeks"
213416|NCT01330030|E2|Reported Event|Matching Placebo|"matching placebo worn 24 hours for 8 weeks
matching placebo: placebo/24hrs for 8 weeks"
213417|NCT01330030|E1|Reported Event|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks
Selegiline: 6mg/24 hrs for 8 weeks"
213418|NCT01330017|B6|Baseline|Total|Total of all reporting groups
213419|NCT01330017|B5|Baseline|Placebo|Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
213420|NCT01330017|B4|Baseline|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
213421|NCT01330017|B3|Baseline|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
213422|NCT01330017|B2|Baseline|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
213423|NCT01330017|B1|Baseline|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
213424|NCT01330017|P5|Participant Flow|Placebo|Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
213425|NCT01330017|P4|Participant Flow|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
213426|NCT01330017|P3|Participant Flow|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
213427|NCT01330017|P2|Participant Flow|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
213428|NCT01330017|P1|Participant Flow|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
213429|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
213430|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
213431|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
213432|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
213433|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
213434|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
213435|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
213436|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
213437|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
213438|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
213439|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
213440|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
213441|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
213442|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
213443|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
213444|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
213445|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
213446|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
213447|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
213448|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
213449|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
213450|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
213451|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
213452|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
213453|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
213454|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
213455|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
213456|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
213457|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
213458|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
215476|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
213459|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
213460|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
213461|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
213462|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
213463|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
213464|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
213465|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
213466|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
213467|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
213468|NCT01330017|E5|Reported Event|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
213469|NCT01330017|E4|Reported Event|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
213470|NCT01330017|E3|Reported Event|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
213471|NCT01330017|E2|Reported Event|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
213472|NCT01330017|E1|Reported Event|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
213473|NCT01329978|B4|Baseline|Total|Total of all reporting groups
213474|NCT01329978|B3|Baseline|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213475|NCT01329978|B2|Baseline|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213476|NCT01329978|B1|Baseline|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213477|NCT01329978|P5|Participant Flow|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
213478|NCT01329978|P4|Participant Flow|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
213479|NCT01329978|P3|Participant Flow|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213480|NCT01329978|P2|Participant Flow|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213481|NCT01329978|P1|Participant Flow|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive sofosbuvir (SOF) 400 mg+pegylated interferon alfa-2a (PEG) 180 µg+ribavirin (RBV) 1000-1200 mg for 12 weeks.
213482|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
213483|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
213484|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213485|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213486|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213487|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
213488|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
213489|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213490|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213491|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213492|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
213493|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
213494|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213495|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213496|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213497|NCT01329978|O4|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
215477|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
213498|NCT01329978|O3|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
213499|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213500|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213501|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213502|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213503|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213504|NCT01329978|O4|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
213505|NCT01329978|O3|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
213506|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213507|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213508|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213509|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213510|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213511|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213512|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213513|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213514|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213515|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213516|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213517|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213518|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213519|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213520|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213521|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213522|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213523|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213524|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213525|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213526|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213527|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213528|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213529|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213530|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213531|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213532|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
213533|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
213534|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213535|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213536|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213537|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
213538|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
213539|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213540|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213541|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213542|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
213543|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
213544|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213545|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213546|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213547|NCT01329978|E3|Reported Event|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
213548|NCT01329978|E2|Reported Event|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
213549|NCT01329978|E1|Reported Event|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
213550|NCT01329939|B5|Baseline|Total|Total of all reporting groups
213551|NCT01329939|B4|Baseline|Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213552|NCT01329939|B3|Baseline|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213553|NCT01329939|B2|Baseline|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213554|NCT01329939|B1|Baseline|Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213555|NCT01329939|P4|Participant Flow|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213556|NCT01329939|P3|Participant Flow|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213557|NCT01329939|P2|Participant Flow|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213558|NCT01329939|P1|Participant Flow|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213559|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213560|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213561|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213562|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213563|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213564|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213565|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213566|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213567|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213568|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213569|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213570|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213571|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213572|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213573|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213574|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213575|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213576|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213577|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213578|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213579|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213580|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213581|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213582|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213583|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213584|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213585|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213586|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213587|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213588|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213589|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213590|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213591|NCT01329939|E4|Reported Event|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213592|NCT01329939|E3|Reported Event|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213593|NCT01329939|E2|Reported Event|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
213594|NCT01329939|E1|Reported Event|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
213595|NCT01329848|B1|Baseline|Discomfort Symptoms|level of discomfort symptoms while performing near work
213596|NCT01329848|P1|Participant Flow|Discomfort Symptoms|levels of discomfort while performing near work
213597|NCT01329848|O1|Outcome|Discomfort Symptoms|level of discomfort symptoms while performing near work
213598|NCT01329848|O1|Outcome|Discomfort Symptoms|level of discomfort symptoms while performing near work
213599|NCT01329848|E1|Reported Event|Changes in Visual Discomfort From Baseline|Visual discomfort while making auto-refraction recordings.
213600|NCT01329679|B1|Baseline|All Study Participants|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days Placebo: Water, lime juice and cherry flavoring
213601|NCT01329679|P2|Participant Flow|Placebo, Then Energy Drink|
213602|NCT01329679|P1|Participant Flow|Energy Drink, Then Placebo|
213603|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
213604|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
213605|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
213606|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
213607|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
213608|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
213609|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
213610|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
213611|NCT01329679|O2|Outcome|Placebo|
213612|NCT01329679|O1|Outcome|5 Hour Energy|
213613|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
213614|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
213615|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
213616|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
213617|NCT01329679|E2|Reported Event|Placebo|Placebo: Water, lime juice and cherry flavoring
213618|NCT01329679|E1|Reported Event|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
213619|NCT01329562|B3|Baseline|Total|Total of all reporting groups
213620|NCT01329562|B2|Baseline|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213621|NCT01329562|B1|Baseline|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213622|NCT01329562|P2|Participant Flow|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213623|NCT01329562|P1|Participant Flow|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213624|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213638|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213625|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213626|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213627|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213628|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213629|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213630|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213631|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213632|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213633|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213634|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213635|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213636|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213637|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213639|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213640|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213641|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213642|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213643|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213644|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213645|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213646|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213647|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213648|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213649|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213650|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213651|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213694|NCT01329263|O1|Outcome|Control|Control group: continued to smoke same, own brand cigarette.
213695|NCT01329263|O2|Outcome|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
213652|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213653|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213654|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213655|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213656|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213657|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213658|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213659|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213660|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213661|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213662|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213663|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213664|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213665|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213696|NCT01329263|O1|Outcome|Control|Control group: continued to smoke same, own brand cigarette.
213697|NCT01329263|O2|Outcome|Control|Control group smoked their own brand cigarette for entire duration of study.
213698|NCT01329263|O1|Outcome|Experimental|Experimental group switched from menthol cigarette to non-menthol cigarette
213666|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213667|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213668|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213669|NCT01329562|E2|Reported Event|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
213670|NCT01329562|E1|Reported Event|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.
All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.
Placebo : A placebo tablet matching Treximet for oral administration."
213671|NCT01329549|B1|Baseline|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
213672|NCT01329549|P1|Participant Flow|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
213673|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
213674|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
213675|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
213676|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
213677|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
213678|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
213679|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
213680|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
213681|NCT01329549|E1|Reported Event|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
213682|NCT01329419|B1|Baseline|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
213683|NCT01329419|P1|Participant Flow|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
213684|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 mg of adefovir dipivoxil administered once daily
213685|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 mg of adefovir dipivoxil administered once daily
213686|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
213687|NCT01329419|E1|Reported Event|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
213688|NCT01329263|B3|Baseline|Total|Total of all reporting groups
213689|NCT01329263|B2|Baseline|Control|Participants smoked their own menthol brand cigarette throughout the study.
213690|NCT01329263|B1|Baseline|Experimental|Group switched from menthol cigarette to non-menthol cigarette
213691|NCT01329263|P2|Participant Flow|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
213692|NCT01329263|P1|Participant Flow|Control|Control group: continued to smoke same, own brand cigarette.
213693|NCT01329263|O2|Outcome|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
213699|NCT01329263|O2|Outcome|Control|Control group smoked their own brand cigarette for entire duration of study.
213700|NCT01329263|O1|Outcome|Experimental|Experimental group switched from menthol cigarette to non-menthol cigarette
213701|NCT01329263|E2|Reported Event|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
213702|NCT01329263|E1|Reported Event|Control|Control group: continued to smoke same, own brand cigarette.
213703|NCT01329198|B3|Baseline|Total|Total of all reporting groups
213704|NCT01329198|B2|Baseline|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects
NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.
One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
213705|NCT01329198|B1|Baseline|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.
NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.
One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
213706|NCT01329198|P2|Participant Flow|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects
NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.
One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
213707|NCT01329198|P1|Participant Flow|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.
NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.
One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
213708|NCT01329198|O5|Outcome|Subject 5|
213709|NCT01329198|O4|Outcome|Subject 4|
213710|NCT01329198|O3|Outcome|Subject 3|
213711|NCT01329198|O2|Outcome|Subject 2|
213712|NCT01329198|O1|Outcome|Subject 1|
213713|NCT01329198|O2|Outcome|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects
NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.
One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
213714|NCT01329198|O1|Outcome|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.
NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.
One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
213715|NCT01329198|E2|Reported Event|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects
NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.
One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
213716|NCT01329198|E1|Reported Event|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.
NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.
One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
213717|NCT01329185|B3|Baseline|Total|Total of all reporting groups
213718|NCT01329185|B2|Baseline|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date
Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
213719|NCT01329185|B1|Baseline|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date
Placebo: 1 capsule twice a day for 14 days prior to transplant date"
213720|NCT01329185|P2|Participant Flow|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date
Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
213721|NCT01329185|P1|Participant Flow|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date
Placebo: 1 capsule twice a day for 14 days prior to transplant date"
213722|NCT01329185|O2|Outcome|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date
Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
213723|NCT01329185|O1|Outcome|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date
Placebo: 1 capsule twice a day for 14 days prior to transplant date"
213724|NCT01329185|E2|Reported Event|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date
Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
213725|NCT01329185|E1|Reported Event|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date
Placebo: 1 capsule twice a day for 14 days prior to transplant date"
213726|NCT01329029|B3|Baseline|Total|Total of all reporting groups
213727|NCT01329029|B2|Baseline|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213728|NCT01329029|B1|Baseline|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213729|NCT01329029|P2|Participant Flow|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213730|NCT01329029|P1|Participant Flow|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213731|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213732|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213733|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213734|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213735|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213736|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213737|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213738|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213739|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213740|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213741|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213742|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213743|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213744|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213745|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213746|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213747|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213748|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213749|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213750|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213751|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213752|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213753|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213754|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213755|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213756|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213757|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213758|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213759|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213760|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213761|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213762|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213763|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213764|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213765|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213766|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213767|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213768|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213769|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213770|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213771|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213772|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213773|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213774|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213775|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213776|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213777|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213778|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213779|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213780|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213861|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
213781|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213782|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213783|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213784|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213785|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213786|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213787|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213788|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213789|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213790|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213791|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213792|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213793|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213794|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213795|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213796|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213797|NCT01329029|E2|Reported Event|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213798|NCT01329029|E1|Reported Event|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
213799|NCT01328964|B4|Baseline|Total|Total of all reporting groups
213800|NCT01328964|B3|Baseline|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
213801|NCT01328964|B2|Baseline|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
213802|NCT01328964|B1|Baseline|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
213803|NCT01328964|P3|Participant Flow|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
213804|NCT01328964|P2|Participant Flow|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
213805|NCT01328964|P1|Participant Flow|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
213806|NCT01328964|O2|Outcome|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
213807|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
213808|NCT01328964|O2|Outcome|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
213809|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
213810|NCT01328964|O2|Outcome|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
213811|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
213812|NCT01328964|O2|Outcome|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
213813|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
213814|NCT01328964|E3|Reported Event|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
213815|NCT01328964|E2|Reported Event|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
213816|NCT01328964|E1|Reported Event|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
213817|NCT01328951|B3|Baseline|Total|Total of all reporting groups
213818|NCT01328951|B2|Baseline|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
213819|NCT01328951|B1|Baseline|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
213820|NCT01328951|P2|Participant Flow|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not epidermal growth factor receptor [EGFR] targeted therapies) or best supportive care (BSC) as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
213821|NCT01328951|P1|Participant Flow|Late Erlotinib|Participants received blinded placebo tablets orally (PO) once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
213822|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213823|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213824|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213825|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213826|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213827|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213828|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213829|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213830|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213831|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213832|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213833|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213834|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
213835|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
213862|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
213863|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
213836|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
213837|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
213838|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
213839|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
213840|NCT01328951|E4|Reported Event|Second-Line Chemotherapy (Early Erlotinib)|Participants who received blinded erlotinib and who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity.
213841|NCT01328951|E3|Reported Event|Second-Line Erlotinib (Late Erlotinib)|Participants who received blinded placebo and who demonstrated disease progression were unblinded and could receive second-line erlotinib as 150-mg tablets PO once daily, provided by the Sponsor. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity.
213842|NCT01328951|E2|Reported Event|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213843|NCT01328951|E1|Reported Event|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
213844|NCT01328873|B1|Baseline|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens
Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
213845|NCT01328873|P1|Participant Flow|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens
Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
213846|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens
Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
213847|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens
Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
213848|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens
Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
213849|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens
Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
213850|NCT01328873|O1|Outcome|Laboratory Testing|"Patients were evaluated by changes on the CT and categorized as follows:
Air space
ground glass/reticular nodular
nodular/cavitary
single patchy infiltrate
These were evaluated on CT scans and all units of measure are the same."
213851|NCT01328873|O1|Outcome|All Patients Will Receive Lab Testing on Bronchoscopy Specimen|
213852|NCT01328873|E1|Reported Event|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens
Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
213853|NCT01328782|B4|Baseline|Total|Total of all reporting groups
213854|NCT01328782|B3|Baseline|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
213855|NCT01328782|B2|Baseline|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
213856|NCT01328782|B1|Baseline|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
213857|NCT01328782|P3|Participant Flow|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
213858|NCT01328782|P2|Participant Flow|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
213859|NCT01328782|P1|Participant Flow|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
213860|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
213864|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
213865|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
213866|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
213867|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
213868|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
213869|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
213870|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
213871|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
213872|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
213873|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
213874|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
213875|NCT01328782|E3|Reported Event|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
213876|NCT01328782|E2|Reported Event|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
213877|NCT01328782|E1|Reported Event|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
213878|NCT01328769|B3|Baseline|Total|Total of all reporting groups
213879|NCT01328769|B2|Baseline|Placebo|Matching placebo dose 80mg once daily
213880|NCT01328769|B1|Baseline|Febuxostat|80mg daily
213881|NCT01328769|P2|Participant Flow|Placebo|Matching placebo dose 80mg once daily
213882|NCT01328769|P1|Participant Flow|Febuxostat|80mg once daily
213883|NCT01328769|O2|Outcome|Placebo|Matching placebo dose 80mg once daily
213884|NCT01328769|O1|Outcome|Febuxostat|80mg daily
213885|NCT01328769|O2|Outcome|Placebo|Matching placebo dose 80mg once daily
213886|NCT01328769|O1|Outcome|Febuxostat|80mg daily
213887|NCT01328769|E2|Reported Event|Placebo|
213888|NCT01328769|E1|Reported Event|Febuxostat|
213889|NCT01328756|B1|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213890|NCT01328756|P1|Participant Flow|Lisdexamfetamine Dimesylate|"Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 milligram (mg) capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
At optimization period, participants started SPD489 30 mg and dose was titrated until acceptable response (30% reduction from baseline in ADHD Rating Scale-IV total score, clinical global impression-improvement [CGI-I]score of 1 or 2 with tolerable side effects) was achieved. Maximum dose was 70mg. Dose adjustments were done in dose maintenance period."
213891|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213892|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213893|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213894|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213895|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213896|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213897|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213898|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213899|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213900|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213901|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213902|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213903|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
214004|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
213904|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
213905|NCT01328756|E1|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (Vyvanse, SPD489) 30 to 70 mg capsule once daily orally.
213906|NCT01328717|B1|Baseline|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
213907|NCT01328717|P1|Participant Flow|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
213908|NCT01328717|O1|Outcome|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
213909|NCT01328717|O1|Outcome|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
213910|NCT01328717|E1|Reported Event|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
213911|NCT01328574|B1|Baseline|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously"
213912|NCT01328574|P1|Participant Flow|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously"
213913|NCT01328574|O5|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 4|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 4 (life threatening) adverse events."
213914|NCT01328574|O4|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 3|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 3 (severe) adverse events."
213915|NCT01328574|O3|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 2|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 2 (moderate) adverse events."
213916|NCT01328574|O2|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 1|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously Grade 1 (mild) adverse events."
213917|NCT01328574|O1|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - All Grades|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously
Adverse events grades 1-4 (mild, moderate, severe and life threatening)."
213918|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously"
213919|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously"
213920|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously"
213921|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously"
213922|NCT01328574|E1|Reported Event|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks
TRC105: 15 mg/kg intravenously"
213923|NCT01328548|B3|Baseline|Total|Total of all reporting groups
213924|NCT01328548|B2|Baseline|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
213925|NCT01328548|B1|Baseline|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
213926|NCT01328548|P2|Participant Flow|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
213927|NCT01328548|P1|Participant Flow|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
213928|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
213929|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
213930|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
213931|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
213932|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
213933|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
213934|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
213935|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
213936|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
213937|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
213938|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
213939|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
213940|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
213941|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
213942|NCT01328548|E2|Reported Event|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
213943|NCT01328548|E1|Reported Event|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
213944|NCT01328496|B3|Baseline|Total|Total of all reporting groups
214005|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
213945|NCT01328496|B2|Baseline|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213946|NCT01328496|B1|Baseline|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213947|NCT01328496|P2|Participant Flow|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213948|NCT01328496|P1|Participant Flow|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213949|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213950|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213951|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213952|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213953|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
215478|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
213954|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.
Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213955|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213956|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.
Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213957|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213958|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observationalal arm.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213959|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213960|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213961|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213962|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
214006|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
214007|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
214008|NCT01328444|E6|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
215479|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
213963|NCT01328496|E2|Reported Event|Observation Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213964|NCT01328496|E1|Reported Event|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.
Intervention: Preparative Regimen
Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
213965|NCT01328444|B1|Baseline|All Study Treatments|Participants were randomized to receive a sequence consisting of 2 of the following treatments: UMEC/VI 125/25 µg , UMEC/VI 62.5/25 µg , UMEC 125 µg , UMEC 62.5 µg , VI 25 µg , or placebo QD via a DPI. Each treatment was administered in the morning for 12 weeks. The treatment periods were seperated by 14-day washout period.
213966|NCT01328444|P6|Participant Flow|UMEC 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
213967|NCT01328444|P5|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
213968|NCT01328444|P4|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
213969|NCT01328444|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
213970|NCT01328444|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
213971|NCT01328444|P1|Participant Flow|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
213972|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
213973|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
213974|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
213975|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
213976|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
213977|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
213978|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
213979|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
213980|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
213981|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
213982|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
213983|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
213984|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
213985|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
213986|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
213987|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
213988|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
213989|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
213990|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
213991|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
213992|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
213993|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
213994|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
213995|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
213996|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
213997|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
213998|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
213999|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
214000|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
214001|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
214002|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
214003|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
214009|NCT01328444|E5|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
214010|NCT01328444|E4|Reported Event|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
214011|NCT01328444|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
214012|NCT01328444|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
214013|NCT01328444|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
214014|NCT01328431|B3|Baseline|Total|Total of all reporting groups
214015|NCT01328431|B2|Baseline|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
214016|NCT01328431|B1|Baseline|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
214017|NCT01328431|P2|Participant Flow|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
214018|NCT01328431|P1|Participant Flow|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
214019|NCT01328431|O2|Outcome|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
214020|NCT01328431|O1|Outcome|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
214021|NCT01328431|O2|Outcome|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
214022|NCT01328431|O1|Outcome|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
214023|NCT01328431|E2|Reported Event|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
214024|NCT01328431|E1|Reported Event|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
214025|NCT01328405|B3|Baseline|Total|Total of all reporting groups
214026|NCT01328405|B2|Baseline|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
214027|NCT01328405|B1|Baseline|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
214028|NCT01328405|P2|Participant Flow|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
214029|NCT01328405|P1|Participant Flow|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
214030|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
214031|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
214032|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
214033|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
214034|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
214035|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
214037|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
214038|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
214039|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
214040|NCT01328405|E2|Reported Event|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
214041|NCT01328405|E1|Reported Event|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
214042|NCT01328379|B4|Baseline|Total|Total of all reporting groups
214043|NCT01328379|B3|Baseline|Dalfampridine-ER 10mg|"10mg, twice daily
Dalfampridine-ER 10mg: 10mg, twice daily"
214044|NCT01328379|B2|Baseline|Dalfampridine-ER 5mg|"5mg, twice daily
Dalfampridine-ER 5mg: 5mg, twice daily"
214045|NCT01328379|B1|Baseline|Placebo|placebo, twice daily
214046|NCT01328379|P3|Participant Flow|Dalfampridine-ER 10mg|"10mg, twice daily
Dalfampridine-ER 10mg: 10mg, twice daily"
214047|NCT01328379|P2|Participant Flow|Dalfampridine-ER 5mg|"5mg, twice daily
Dalfampridine-ER 5mg: 5mg, twice daily"
214048|NCT01328379|P1|Participant Flow|Placebo|placebo, twice daily
214049|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily
Dalfampridine-ER 10mg: 10mg, twice daily"
214050|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily
Dalfampridine-ER 5mg: 5mg, twice daily"
214051|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
214052|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily
Dalfampridine-ER 10mg: 10mg, twice daily"
214053|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily
Dalfampridine-ER 5mg: 5mg, twice daily"
214054|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
214055|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily
Dalfampridine-ER 10mg: 10mg, twice daily"
214056|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily
Dalfampridine-ER 5mg: 5mg, twice daily"
214057|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
214058|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily
Dalfampridine-ER 10mg: 10mg, twice daily"
214059|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily
Dalfampridine-ER 5mg: 5mg, twice daily"
214060|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
214061|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily
Dalfampridine-ER 10mg: 10mg, twice daily"
214062|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily
Dalfampridine-ER 5mg: 5mg, twice daily"
214063|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
214064|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily
Dalfampridine-ER 10mg: 10mg, twice daily"
214065|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily
Dalfampridine-ER 5mg: 5mg, twice daily"
214066|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
214067|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily
Dalfampridine-ER 10mg: 10mg, twice daily"
214068|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily
Dalfampridine-ER 5mg: 5mg, twice daily"
214069|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
214070|NCT01328379|E3|Reported Event|Dalfampridine-ER 10mg|"10mg, twice daily
Dalfampridine-ER 10mg: 10mg, twice daily"
214071|NCT01328379|E2|Reported Event|Dalfampridine-ER 5mg|"5mg, twice daily
Dalfampridine-ER 5mg: 5mg, twice daily"
214072|NCT01328379|E1|Reported Event|Placebo|placebo, twice daily
214073|NCT01328366|B1|Baseline|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214074|NCT01328366|P1|Participant Flow|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214075|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214076|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214077|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214078|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214079|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214080|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214081|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214082|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214083|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214781|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
214084|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214085|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214086|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214087|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214088|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214089|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214090|NCT01328366|E1|Reported Event|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
214091|NCT01328184|B1|Baseline|Study Overall|A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days.
214092|NCT01328184|P1|Participant Flow|Study Overall|A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days.
214093|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214094|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214095|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214096|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214097|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214098|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214099|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214100|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214101|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214102|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214103|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214104|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214105|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214106|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214107|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214108|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214109|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214110|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214111|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214112|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214113|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214114|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214115|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214116|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214117|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214118|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214119|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214120|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214121|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214122|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214123|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214124|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214125|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214126|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214127|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214128|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
214129|NCT01328184|E2|Reported Event|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
214130|NCT01328184|E1|Reported Event|Microgynon|One tablet of Microgynon once daily for 14 days.
215480|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
214131|NCT01328158|B1|Baseline|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214132|NCT01328158|P1|Participant Flow|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214133|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214134|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214135|NCT01328158|O3|Outcome|Lopinavir/Ritonavir: Baseline CDC Category Unknown|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214136|NCT01328158|O2|Outcome|Lopinavir/Ritonavir: Baseline CDC Category C|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214137|NCT01328158|O1|Outcome|Lopinavir/Ritonavir: Baseline CDC Category A|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214138|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214139|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214140|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214141|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214142|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214143|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214144|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214145|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214146|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214147|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214148|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214149|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214150|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214151|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214152|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214153|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214154|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214155|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214156|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214157|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214158|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214159|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214160|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214161|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214162|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214163|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214164|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214165|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214166|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214167|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214168|NCT01328158|E1|Reported Event|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
214169|NCT01328080|B1|Baseline|Targeted UV-B|
214170|NCT01328080|P1|Participant Flow|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
214171|NCT01328080|O1|Outcome|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
214172|NCT01328080|E1|Reported Event|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
214173|NCT01328054|B1|Baseline|Placebo and Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214174|NCT01328054|P2|Participant Flow|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 milligrams (mg) (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214175|NCT01328054|P1|Participant Flow|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
214176|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214177|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214178|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214179|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214180|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214181|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214182|NCT01328054|O1|Outcome|Placebo/ Lapatinib|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214183|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214184|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4
214185|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214186|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214187|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214188|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
214189|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4
214190|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
214191|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214192|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
214193|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214194|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
214195|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214196|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
214197|NCT01328054|E2|Reported Event|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
214198|NCT01328054|E1|Reported Event|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
214199|NCT01328041|B1|Baseline|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214200|NCT01328041|P1|Participant Flow|Dolutegravir 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice a day (BID).
214201|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214202|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214203|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214204|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214205|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214206|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214207|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214208|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214209|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214210|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214211|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214212|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214213|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214214|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214215|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214216|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214217|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214218|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214219|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214220|NCT01328041|E1|Reported Event|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
214221|NCT01327989|B1|Baseline|Solitaire™ FR Device|Eligible subjects treated with the Solitaire™ FR device.
214222|NCT01327989|P1|Participant Flow|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device"
214223|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device"
214224|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device"
214225|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device"
214226|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device"
214227|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device"
214228|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device"
214229|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device"
214230|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device"
214231|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device"
214232|NCT01327989|E1|Reported Event|Solitaire™ FR Device|Eligible subjects treated with the Solitaire™ FR device.
214233|NCT01327976|B3|Baseline|Total|Total of all reporting groups
214234|NCT01327976|B2|Baseline|Sham (Non-active Device)|"The Sham group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
214235|NCT01327976|B1|Baseline|vBloc (Active Device)|"The vBloc group will receive a functional device that will deliver charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy."
214236|NCT01327976|P2|Participant Flow|Sham (Non-active Device)|"The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
214237|NCT01327976|P1|Participant Flow|vBloc (Active Device)|"The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy."
214238|NCT01327976|O2|Outcome|Sham (Non-active Device)|The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
214239|NCT01327976|O1|Outcome|vBloc (Active Device)|The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
214351|NCT01327651|O1|Outcome|Cape Town, South Africa, Seroconverted Participant #1|#1 seroconverted participants in Cape Town, South Africa, not randomized
214240|NCT01327976|O2|Outcome|Sham (Non-active Device)|"The Sham group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBlocTherapy"
214241|NCT01327976|O1|Outcome|vBloc (Active Device)|"The vBloc group will receive a functional device that will deliver charge to the vagus nerve during the study period
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy"
214242|NCT01327976|O2|Outcome|Sham (Non-active Device)|The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
214243|NCT01327976|O1|Outcome|vBloc (Active Device)|The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
214244|NCT01327976|E2|Reported Event|Sham (Non-active Device)|"The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
214245|NCT01327976|E1|Reported Event|vBloc (Active Device)|"The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBlocTherapy."
214246|NCT01327885|B3|Baseline|Total|Total of all reporting groups
214247|NCT01327885|B2|Baseline|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
214248|NCT01327885|B1|Baseline|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
214249|NCT01327885|P2|Participant Flow|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
214250|NCT01327885|P1|Participant Flow|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
214251|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
214252|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
214253|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
214254|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
214255|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
214256|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
214257|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
214258|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
214259|NCT01327885|E2|Reported Event|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
214260|NCT01327885|E1|Reported Event|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
214261|NCT01327703|B1|Baseline|Entire Study Population|Includes randomized participants who received Panzytrat® 25,000 first and Kreon® 25,000 first.
214262|NCT01327703|P2|Participant Flow|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
214284|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214285|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214263|NCT01327703|P1|Participant Flow|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
214264|NCT01327703|O2|Outcome|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
214265|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
214266|NCT01327703|O2|Outcome|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
214267|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
214268|NCT01327703|O2|Outcome|Kreon®, First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
214269|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
214270|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214271|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214272|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214273|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214274|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214275|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214276|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214277|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214278|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214279|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214280|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214281|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214282|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214283|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214286|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214287|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214288|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214289|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214290|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214291|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214292|NCT01327703|E2|Reported Event|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214293|NCT01327703|E1|Reported Event|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
214294|NCT01327677|B3|Baseline|Total|Total of all reporting groups
214295|NCT01327677|B2|Baseline|IVPCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out"
214296|NCT01327677|B1|Baseline|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.
Fentanyl: 25-50 mcg every 20 minutes"
214297|NCT01327677|P2|Participant Flow|PCA Fentanyl|"A patient can self-administer fentanyl intravenously using a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out"
214298|NCT01327677|P1|Participant Flow|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.
Fentanyl: 25-50 mcg every 20 minutes"
214299|NCT01327677|O2|Outcome|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out"
214300|NCT01327677|O1|Outcome|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.
Fentanyl: 25-50 mcg every 20 minutes"
214301|NCT01327677|O2|Outcome|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out"
214302|NCT01327677|O1|Outcome|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.
Fentanyl: 25-50 mcg every 20 minutes"
214303|NCT01327677|O2|Outcome|Intravenous Patient-controlled Analgesia (IVPCA) Fentanyl|"Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out"
214304|NCT01327677|O1|Outcome|(Pro re Nata) PRN Fentanyl|"A nurse can give the patient up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.
Fentanyl: 25-50 mcg every 20 minutes"
214305|NCT01327677|O2|Outcome|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out"
214306|NCT01327677|O1|Outcome|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.
Fentanyl: 25-50 mcg every 20 minutes"
214307|NCT01327677|E2|Reported Event|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out"
214308|NCT01327677|E1|Reported Event|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.
Fentanyl: 25-50 mcg every 20 minutes"
214309|NCT01327651|B10|Baseline|Total|Total of all reporting groups
214310|NCT01327651|B9|Baseline|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214311|NCT01327651|B8|Baseline|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214312|NCT01327651|B7|Baseline|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214313|NCT01327651|B6|Baseline|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214314|NCT01327651|B5|Baseline|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214315|NCT01327651|B4|Baseline|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214316|NCT01327651|B3|Baseline|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214317|NCT01327651|B2|Baseline|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214318|NCT01327651|B1|Baseline|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214319|NCT01327651|P9|Participant Flow|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214320|NCT01327651|P8|Participant Flow|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214321|NCT01327651|P7|Participant Flow|Daily Dosing, Harlem|Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
214322|NCT01327651|P6|Participant Flow|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214323|NCT01327651|P5|Participant Flow|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors"
214324|NCT01327651|P4|Participant Flow|Daily Dosing, Bangkok|Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
214325|NCT01327651|P3|Participant Flow|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214326|NCT01327651|P2|Participant Flow|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214327|NCT01327651|P1|Participant Flow|Daily Dosing, Cape Town|Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
214328|NCT01327651|O12|Outcome|Harlem, United States, Seroconverted Participant #2|#2 seroconverted participants in Harlem, United States, daily arm
214329|NCT01327651|O11|Outcome|Harlem, United States, Seroconverted Participant #1|#1 seroconverted participants in Harlem, United States, not randomized
214330|NCT01327651|O10|Outcome|Bangkok, Thailand, Seroconverted Participant #2|#2 seroconverted participants in Bangkok, Thailand, not randomized
214331|NCT01327651|O9|Outcome|Bangkok, Thailand, Seroconverted Participant #1|#1 seroconverted participants in Bangkok, Thailand, not randomized
214332|NCT01327651|O8|Outcome|Cape Town, South Africa, Seroconverted Participant #8|#8 seroconverted participants in Cape Town, South Africa, event-driven arm
214333|NCT01327651|O7|Outcome|Cape Town, South Africa, Seroconverted Participant #7|#7 seroconverted participants in Cape Town, South Africa, event-driven arm
214334|NCT01327651|O6|Outcome|Cape Town, South Africa, Seroconverted Participant #6|#6 seroconverted participants in Cape Town, South Africa, time-driven arm
214335|NCT01327651|O5|Outcome|Cape Town, South Africa, Seroconverted Participant #5|#5 seroconverted participants in Cape Town, South Africa, time-driven arm
214336|NCT01327651|O4|Outcome|Cape Town, South Africa, Seroconverted Participant #4|#4 seroconverted participants in Cape Town, South Africa, daily arm
214337|NCT01327651|O3|Outcome|Cape Town, South Africa, Seroconverted Participant #3|#3 seroconverted participants in Cape Town, South Africa, not randomized
214338|NCT01327651|O2|Outcome|Cape Town, South Africa, Seroconverted Participant #2|#2 seroconverted participants in Cape Town, South Africa, not randomized
214339|NCT01327651|O1|Outcome|Cape Town, South Africa, Seroconverted Participant #1|#1 seroconverted participants in Cape Town, South Africa, not randomized
214340|NCT01327651|O12|Outcome|Harlem, United States, Seroconverted Participant #2|#2 seroconverted participants in Harlem, United States, daily arm
214341|NCT01327651|O11|Outcome|Harlem, United States, Seroconverted Participant #1|#1 seroconverted participants in Harlem, United States, not randomized
214342|NCT01327651|O10|Outcome|Bangkok, Thailand, Seroconverted Participant #2|#2 seroconverted participants in Bangkok, Thailand, not randomized
214343|NCT01327651|O9|Outcome|Bangkok, Thailand, Seroconverted Participant #1|#1 seroconverted participants in Bangkok, Thailand, not randomized
214344|NCT01327651|O8|Outcome|Cape Town, South Africa, Seroconverted Participant #8|#8 seroconverted participants in Cape Town, South Africa, event-driven arm
214345|NCT01327651|O7|Outcome|Cape Town, South Africa, Seroconverted Participant #7|#7 seroconverted participants in Cape Town, South Africa, event-driven arm
214346|NCT01327651|O6|Outcome|Cape Town, South Africa, Seroconverted Participant #6|#6 seroconverted participants in Cape Town, South Africa, time-driven arm
214347|NCT01327651|O5|Outcome|Cape Town, South Africa, Seroconverted Participant #5|#5 seroconverted participants in Cape Town, South Africa, time-driven arm
214348|NCT01327651|O4|Outcome|Cape Town, South Africa, Seroconverted Participant #4|#4 seroconverted participants in Cape Town, South Africa, daily arm
214349|NCT01327651|O3|Outcome|Cape Town, South Africa, Seroconverted Participant #3|#3 seroconverted participants in Cape Town, South Africa, not randomized
214350|NCT01327651|O2|Outcome|Cape Town, South Africa, Seroconverted Participant #2|#2 seroconverted participants in Cape Town, South Africa, not randomized
214352|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214353|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214354|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214355|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214356|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214357|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214358|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214359|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214360|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214361|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214362|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214363|NCT01327651|O7|Outcome|Daily Dosing, Harlem|Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
214364|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214365|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors"
214366|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
214367|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214368|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214369|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
214370|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214371|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214372|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214373|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214374|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214375|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214376|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214377|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214378|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214379|NCT01327651|O3|Outcome|Harlem, United States|Columbia University Medical Center Institutional Review Board in New York is the IRB of record for the New York site.
214380|NCT01327651|O2|Outcome|Bangkok, Thailand|The Institutional Review Board, Human Research Protection Office, US Centers for Disease Control and Prevention and the Ethical Review Committee for Research in Human Subjects, Department of Medical Sciences, Ministry of Public Health, Thailand are the IRBs of record for the Bangkok site
214381|NCT01327651|O1|Outcome|Cape Town, South Africa|The University of Cape Town in Cape Town is the IRB of record for the Cape Town site
214382|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214383|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214384|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214385|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214386|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214387|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214388|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214389|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214390|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214391|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214392|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214393|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214394|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214395|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214396|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214397|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214398|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214399|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214400|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214401|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214402|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214403|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214404|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214405|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214406|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214407|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214408|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214409|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214410|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214411|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214412|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214413|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214414|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214415|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214416|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214417|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214418|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214419|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214420|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214421|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214422|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214423|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214424|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214425|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214426|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214427|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214428|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214429|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214430|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214431|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214432|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214433|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214434|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214435|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214436|NCT01327651|E9|Reported Event|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214437|NCT01327651|E8|Reported Event|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214438|NCT01327651|E7|Reported Event|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214439|NCT01327651|E6|Reported Event|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214440|NCT01327651|E5|Reported Event|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214441|NCT01327651|E4|Reported Event|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214442|NCT01327651|E3|Reported Event|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214443|NCT01327651|E2|Reported Event|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214444|NCT01327651|E1|Reported Event|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
214445|NCT01327599|B1|Baseline|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
214446|NCT01327599|P1|Participant Flow|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
214447|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
214448|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
214449|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
214450|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
214451|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
214452|NCT01327599|E1|Reported Event|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
214453|NCT01327547|B3|Baseline|Total|Total of all reporting groups
214454|NCT01327547|B2|Baseline|Placebo|Participants who received placebo in combination with HAART
214455|NCT01327547|B1|Baseline|Maraviroc|Participants who received maraviroc in combination with HAART
214456|NCT01327547|P2|Participant Flow|Placebo|Participants who received placebo in combination with HAART
214457|NCT01327547|P1|Participant Flow|Maraviroc|Participants who received maraviroc in combination with HAART
214458|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214459|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214460|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214461|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214462|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214463|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214464|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214465|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214466|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214467|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214468|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214469|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214470|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214471|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214472|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214473|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214474|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214475|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214476|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214477|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214478|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214479|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214480|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214481|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214482|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214483|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214484|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214485|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214486|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
214487|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
214488|NCT01327547|E2|Reported Event|Placebo|Participants who received placebo in combination with HAART
214489|NCT01327547|E1|Reported Event|Maraviroc|Participants who received maraviroc in combination with HAART
214490|NCT01327508|B3|Baseline|Total|Total of all reporting groups
214491|NCT01327508|B2|Baseline|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes
Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
214492|NCT01327508|B1|Baseline|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.
TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
214493|NCT01327508|P2|Participant Flow|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes
Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
214494|NCT01327508|P1|Participant Flow|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.
TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
214495|NCT01327508|O2|Outcome|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes
Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
214496|NCT01327508|O1|Outcome|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.
TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
214497|NCT01327508|O2|Outcome|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes
Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
214845|NCT01325623|O2|Outcome|QOLIE-31-P Scores at 6 Months|QOLIE‐31‐P Scores at Follow-Up Visits
214498|NCT01327508|O1|Outcome|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.
TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
214499|NCT01327508|E2|Reported Event|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes
Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
214500|NCT01327508|E1|Reported Event|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.
TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
214501|NCT01327482|B1|Baseline|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
214502|NCT01327482|P1|Participant Flow|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
214503|NCT01327482|O1|Outcome|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
214504|NCT01327482|O1|Outcome|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
214505|NCT01327482|E1|Reported Event|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
214506|NCT01327339|B1|Baseline|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
214507|NCT01327339|P1|Participant Flow|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 milligrams (mg), 1 mg, 2 mg of ropinirole administered once daily. All subjects will be administered of Requip in normal prescription use. Dosage regimen can be changed by the investigator according to the prescribing information.
214508|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
214509|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
214510|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
214511|NCT01327339|E1|Reported Event|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
214512|NCT01327313|B5|Baseline|Total|Total of all reporting groups
214513|NCT01327313|B4|Baseline|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214514|NCT01327313|B3|Baseline|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214515|NCT01327313|B2|Baseline|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214516|NCT01327313|B1|Baseline|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214517|NCT01327313|P4|Participant Flow|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214518|NCT01327313|P3|Participant Flow|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214519|NCT01327313|P2|Participant Flow|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214520|NCT01327313|P1|Participant Flow|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214521|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214522|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214523|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214524|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214525|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214526|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214527|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214528|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214529|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214530|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214531|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214698|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214532|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214533|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214534|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214535|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214536|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214537|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214538|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214539|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214540|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214541|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214542|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214543|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214544|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214545|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214546|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214547|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214548|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214549|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214550|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214551|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214552|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214553|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214554|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214555|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214556|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214557|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214558|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214559|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214560|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214561|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214562|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214563|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214564|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214565|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214566|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214567|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214568|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214569|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214570|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214571|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214572|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214573|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214574|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214575|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214576|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214577|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214578|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214579|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214580|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214581|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214582|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214583|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214584|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214585|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214586|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214587|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214588|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214589|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214590|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214591|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214592|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214593|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214594|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214595|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214596|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214597|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214598|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214599|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214600|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214601|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214602|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214603|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214604|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214605|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214606|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214607|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214608|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214609|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214610|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214611|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214612|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214613|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214614|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214615|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214616|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214617|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214618|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214619|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214620|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214621|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214622|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214623|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214624|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214625|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214626|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214627|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214628|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214629|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214630|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214631|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214632|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214633|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214634|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214635|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214636|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214637|NCT01327313|E4|Reported Event|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214638|NCT01327313|E3|Reported Event|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214639|NCT01327313|E2|Reported Event|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214640|NCT01327313|E1|Reported Event|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
214641|NCT01327300|B1|Baseline|All Study Participants|All participants were randomized to receive both mesalamine and placebo.
214642|NCT01327300|P2|Participant Flow|Placebo Then Mesalamine|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.
Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm."
214643|NCT01327300|P1|Participant Flow|Mesalamine Then Placebo|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.
Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm."
214644|NCT01327300|O2|Outcome|Placebo|"This group received the placebo for 12 weeks and after a 12 week treatment period, the ratio of lactulose to mannitol was measured.
Two patients in this cross-over study did not provide a 24 hour urine sample needed to obtain the lactulose /mannitol ratio."
214645|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks and after a 12 week treatment period, the ratio of lactulose to mannitol was measured.
214646|NCT01327300|O2|Outcome|Placebo|This group will receive the Placebo for 12 weeks. Comparison of the change in HADS score after 12 weeks of placebo is made to baseline score.
214647|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks . Comparison of the change in HADS score after 12 weeks of mesalamine is made to baseline score.
214648|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks.
The data below show the change in IBS-QOL scores from baseline after 12 weeks of intervention."
214649|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks.
The data below show the change in IBS-QOL scores from baseline after 12 weeks of intervention."
214650|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.
Values reported at the baseline FBDSI score minus the 12 week FBDSI score with placebo."
214651|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.
Data is reported as baseline value minus 12 week mean FBDSI value with mesalamine."
214652|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.
The data below reflect the change in the increase in inflammation with regards to increased mast cells, eosinophils counts and number of activated T lymphocytes after 12 week mesalamine from baseline level of inflammation"
214653|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.
The data below reflect the change in the increase in inflammation with regards to increased mast cells, eosinophils counts and number of activated T lymphocytes after 12 week mesalamine from baseline level of inflammation."
214654|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks.
Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks."
214655|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks
214699|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214700|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214656|NCT01327300|E2|Reported Event|Placebo Then Mesalamine|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.
Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm."
214657|NCT01327300|E1|Reported Event|Mesalamine Then Placebo|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.
Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm."
214658|NCT01327053|B3|Baseline|Total|Total of all reporting groups
214659|NCT01327053|B2|Baseline|LDE225 800 mg|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214660|NCT01327053|B1|Baseline|LDE225 200 mg|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214661|NCT01327053|P2|Participant Flow|LDE225 800 mg|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214662|NCT01327053|P1|Participant Flow|LDE225 200 mg|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214663|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214664|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214665|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214666|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214667|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214668|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214669|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214670|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214671|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214672|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214673|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214674|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214701|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214675|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214676|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214677|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214678|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214679|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214680|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214681|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214682|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214683|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214684|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214685|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214686|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214687|NCT01327053|E2|Reported Event|LDE225 800 mg qd|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214688|NCT01327053|E1|Reported Event|LDE225 200 mg qd|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
214689|NCT01326962|B1|Baseline|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
214690|NCT01326962|P1|Participant Flow|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
214691|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214692|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214693|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214694|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214695|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214696|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214697|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214756|NCT01326026|B3|Baseline|Total|Total of all reporting groups
214702|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214703|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
214704|NCT01326962|E1|Reported Event|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
214705|NCT01326910|B3|Baseline|Total|Total of all reporting groups
214706|NCT01326910|B2|Baseline|19306-137|Marketed Topical cream applied twice daily (or as needed)
214707|NCT01326910|B1|Baseline|19306-127|Experimental Topical cream applied twice daily (or as needed)
214708|NCT01326910|P2|Participant Flow|19306-137|Marketed Topical cream applied twice daily (or as needed)
214709|NCT01326910|P1|Participant Flow|19306-127|Experimental Topical cream applied twice daily (or as needed)
214710|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
214711|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
214712|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
214713|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
214714|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
214715|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
214716|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
214717|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
214718|NCT01326910|E2|Reported Event|19306-137|Marketed Topical cream applied twice daily (or as needed)
214719|NCT01326910|E1|Reported Event|19306-127|Experimental Topical cream applied twice daily (or as needed)
214720|NCT01326845|B3|Baseline|Total|Total of all reporting groups
214721|NCT01326845|B2|Baseline|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
214722|NCT01326845|B1|Baseline|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
214723|NCT01326845|P2|Participant Flow|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
214724|NCT01326845|P1|Participant Flow|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
214725|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
214726|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
214727|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
214728|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
214729|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
214730|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
214731|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
214732|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
214733|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
214734|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
214735|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
214736|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
214737|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
214738|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
214739|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
214740|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
214741|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
214742|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
214743|NCT01326845|E2|Reported Event|ICL pm|ICL pm
214744|NCT01326845|E1|Reported Event|ICL am|ICL am
214745|NCT01326533|B3|Baseline|Total|Total of all reporting groups
214746|NCT01326533|B2|Baseline|Placebo|Placebo daily
214747|NCT01326533|B1|Baseline|Hydroxychloroquine|Hydroxychloroquine sulfate PO 400 mg daily
214748|NCT01326533|P2|Participant Flow|Placebo|13 weeks of placebo PO
214749|NCT01326533|P1|Participant Flow|Hydroxychloroquine|13 weeks of hydroxychloroquine sulfate PO 400 mg/day
214750|NCT01326533|O2|Outcome|Placebo|PO daily for 13 weeks
214751|NCT01326533|O1|Outcome|Hydroxychloroquine|400 mg PO daily for 13 weeks
214752|NCT01326533|O2|Outcome|Placebo|PO daily for 13 weeks
214753|NCT01326533|O1|Outcome|Hydroxychloroquine|400 mg PO daily for 13 weeks
214754|NCT01326533|E2|Reported Event|Placebo|Placebo PO
214755|NCT01326533|E1|Reported Event|Hydroxychloroquine|Hydroxychloroquine sulfate PO 400mg/day
214757|NCT01326026|B2|Baseline|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
214758|NCT01326026|B1|Baseline|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
214759|NCT01326026|P2|Participant Flow|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
214760|NCT01326026|P1|Participant Flow|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
214761|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
214762|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
214763|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
214764|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
214765|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
214766|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
214767|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
214768|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
214769|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
214770|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
214771|NCT01326026|E2|Reported Event|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
214772|NCT01326026|E1|Reported Event|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
214773|NCT01325870|B4|Baseline|Total|Total of all reporting groups
214774|NCT01325870|B3|Baseline|S-CPR|S-CPR: standard manual CPR
214775|NCT01325870|B2|Baseline|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
214776|NCT01325870|B1|Baseline|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
214777|NCT01325870|P3|Participant Flow|S-CPR|S-CPR: standard manual CPR
214778|NCT01325870|P2|Participant Flow|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
214779|NCT01325870|P1|Participant Flow|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
214782|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
214783|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
214784|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
214785|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
214786|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
214787|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
214788|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
214789|NCT01325870|E3|Reported Event|S-CPR|S-CPR: standard manual CPR
214790|NCT01325870|E2|Reported Event|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
214791|NCT01325870|E1|Reported Event|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
214792|NCT01325792|B1|Baseline|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia
GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
214793|NCT01325792|P1|Participant Flow|Single-staged Open Complex Ventral Incisional Hernia Repair|GORE® BIO-A® Tissue Reinforcement to reinforce the midline fascial closure in single-staged open complex ventral incisional (primary or recurrent anterior abdominal wall) hernia repair.
214794|NCT01325792|O1|Outcome|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia
GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
214795|NCT01325792|O1|Outcome|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia
GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
214796|NCT01325792|E1|Reported Event|GORE® BIO-A® Tissue Reinforcement|Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.
214797|NCT01325714|B3|Baseline|Total|Total of all reporting groups
214798|NCT01325714|B2|Baseline|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
214799|NCT01325714|B1|Baseline|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
214800|NCT01325714|P2|Participant Flow|Arm 2: Enhanced Usual Care|107 caregivers were randomized to Enhanced Usual Care. Three were excluded at baseline because of aggression and two dropped out prior to baseline (one withdrew and one deceased). 102 caregivers were included in primary analysis. Dyads assigned to EU-PC received 8 weekly 15-minute phone calls to query symptom severity, ascertain needs for immediate psychiatric care, and provide minimal support. Primary care physicians of patients assigned to both groups received American Medical Association Continuing Medical Education print material on treating pain in older adults, as well as feedback progress notes documenting the PWD’s level of pain and depression at baseline, 3 months, 6 months, and 12 months
214801|NCT01325714|P1|Participant Flow|Arm 1: PAVeD Intervention|106 caregivers were randomized to the PAVeD intervention. Five were excluded at baseline because of aggression. 101 caregivers were included in the primary analysis. Dyads assigned to PAVeD received 6 to 8 weekly sessions of 45-minute home visits. PAVeD consists of 4 weekly 45- minute “core” sessions (“Recognizing Pain”; “Recognizing and Responding to Pain and Distress”; “Enhancing Communication”; “Making Daily Activities More Pleasant and Enjoyable”) and 2 of 4 elective sessions (“Medical Treatments and Talking to Your Doctor,” “Rest and Relaxation Strategies,” “Communication Problems and Challenges,” and “Increasing Pleasant Activities”), chosen with the patient and/or caregiver through collaborative goal setting during the first session. The intervention includes didactics, skill-building, discussion, and role-playing guided by a clinician manual and caregiver workbook.
214802|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
214803|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
214846|NCT01325623|O1|Outcome|QOLIE-31-P Scores at 3 Months|QOLIE‐31‐P Scores at Follow-Up Visits
214847|NCT01325623|O3|Outcome|Unstimulated Seizures|Unstimulated seizures with >20% increase in heart rate.
214848|NCT01325623|O2|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
214804|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
214805|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
214806|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
214807|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
214808|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
214809|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
214810|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
214811|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
214812|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
214813|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
214814|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
214815|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
214849|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
214850|NCT01325623|O3|Outcome|Unstimulated Seizures|Unstimulated seizures with >20% increase in heart rate.
214851|NCT01325623|O2|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
214816|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
214817|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
214818|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain.
N = 102"
214819|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. N = 101"
214820|NCT01325714|E2|Reported Event|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
214821|NCT01325714|E1|Reported Event|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
214822|NCT01325701|B3|Baseline|Total|Total of all reporting groups
214823|NCT01325701|B2|Baseline|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
214824|NCT01325701|B1|Baseline|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
214825|NCT01325701|P2|Participant Flow|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
214826|NCT01325701|P1|Participant Flow|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
214827|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
214828|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis
214829|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
214830|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
214831|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
214832|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
214833|NCT01325701|E2|Reported Event|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
214834|NCT01325701|E1|Reported Event|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
214835|NCT01325623|B1|Baseline|VNS Therapy (Safety Population)|The safety population consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2.
214836|NCT01325623|P1|Participant Flow|Enrolled and Treated Population (Safety Population)|"Consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2. The safety population will be used for all safety analyses. (N=31 subjects).
In version 2 of the AspireSR VNS Therapy System, the TVS diodes (present in version 1) were removed from the electrical circuit to address the accumulation of electrical charge on the sensing node (e.g. generator-can) following delivery of a stimulation."
214837|NCT01325623|O1|Outcome|Percentage Change in Heart Rate|Average percentage change in heart rate from pre-stimulation period to heart rate during VNS Therapy Stimulation, following VNS Therapy Stimulation, and following the black-out period.
214838|NCT01325623|O4|Outcome|Unstimulated Seizures|Unstimulated seizures with =>20% increase in heart rate.
214839|NCT01325623|O3|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
214840|NCT01325623|O2|Outcome|All EMU Stimulated Seizures|Stimulated Seizures with >= 20% increase in heart rate
214841|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
214842|NCT01325623|O5|Outcome|QOLIE-31-P Scores at 24 Months|QOLIE‐31‐P Scores at Follow-Up Visits
214843|NCT01325623|O4|Outcome|QOLIE-31-P Scores at 18 Months|QOLIE‐31‐P Scores at Follow-Up Visits
214844|NCT01325623|O3|Outcome|QOLIE-31-P Scores at 12 Months|QOLIE‐31‐P Scores at Follow-Up Visits
214852|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
214853|NCT01325623|O1|Outcome|Proportion of Seizures Ending During Stimulation by Type|EMU seizures that were treated with Automatic Stimulation and ended during the course of the stimulation
214854|NCT01325623|O5|Outcome|SSQ Scores at 24 Months|Change From Baseline at Each Category
214855|NCT01325623|O4|Outcome|SSQ Scores at 18 Months|Change From Baseline at Each Category
214856|NCT01325623|O3|Outcome|SSQ Scores at 12 Months|Change From Baseline at Each Category
214857|NCT01325623|O2|Outcome|SSQ Scores at 6 Months|Change From Baseline at Each Category
214858|NCT01325623|O1|Outcome|SSQ Scores at 3 Months|Change From Baseline at Each Category
214859|NCT01325623|O4|Outcome|Generalized Tonic Clonic Sz|NHS3 Scores at Follow-Up Visits
214860|NCT01325623|O3|Outcome|CPS w/2nd GTC|NHS3 Scores at Follow-Up Visits
214861|NCT01325623|O2|Outcome|Complex Partial Seizures (CPS)|NHS3 Scores at Follow-Up Visits
214862|NCT01325623|O1|Outcome|Simple Partial Seizures|NHS3 Scores at Follow-Up Visits
214863|NCT01325623|O2|Outcome|Partial Seizures|"Summary of Responders (>= 50% Seizure Counts Reduction per Month) by Visit (Partial Seizures)
Partial seizures consist of simple partial, complex partial, complex partial with secondarily generalized seizures."
214864|NCT01325623|O1|Outcome|Overall Seizure Responder Rate|Summary of Responders (>= 50% Seizure Counts Reduction per Month) by Visit (All seizure types)
214865|NCT01325623|O2|Outcome|Day 5 EMU or EMU Discharge|Assessment of Device Usability at EMU (Day 5 or Discharge)
214866|NCT01325623|O1|Outcome|Implant/Recovery|Assessment of Device Usability at Implant and Recovery
214867|NCT01325623|O2|Outcome|Latency Analysis of All Seizure Types|The time difference between SDA seizure detection time and the annotated seizure onset time (ALL seizures).
214868|NCT01325623|O1|Outcome|Latency Analysis of Ictal Tachycardia Seizures|"The time difference between SDA detection of the ictal tachycardia seizure and the annotated seizure onset time.
Ictal Tachycardia Seizure is defined as a seizure with an increase from a baseline heart rate to a rate that is greater than 100 bpm and is at least a 55% increase or 35 bpm."
214869|NCT01325623|O1|Outcome|Beat Detection Sensitivity By Device IPG|"Cardiac R‐Wave Detection Sensitivity Based on Device IPG and ECG Monitor Comparison for 10 second Detection Window. n denotes the total number of patients with available R‐R wave data at the visit time point."
214870|NCT01325623|O1|Outcome|Potential False Positives|Potential False Positives Based on Heart Rate Increase Associated with Seizures by Randomized SDA Setting (AutoStim Per Hour)
214871|NCT01325623|O1|Outcome|% Sensitivity|Total number of seizures detected by M106 divided by the total number of seizures reported (investigator + confirmation by triple review) during the EMU stay
214872|NCT01325623|O1|Outcome|% Sensitivity|Total number of seizures detected by M106 divided by the total number of seizures reported (investigator + confirmation by triple review) during the EMU stay
214873|NCT01325623|O3|Outcome|Total|Seizures from an ITT subject that were either identified by the investigator during EMU evaluation or during the triple review process of EEG data.
214874|NCT01325623|O2|Outcome|Reported by Triple Review|All seizures that occurred during EMU stay and that were identified by triple review post EMU.
214875|NCT01325623|O1|Outcome|Reported by Investigators|All seizures that occurred during EMU stay and that were identified by investigators.
214876|NCT01325623|E1|Reported Event|VNS Therapy - Safety Population|All adverse events were collected from baseline up to the 24-month follow-up visit for all subjects treated/implanted with the AspireSR® VNS Therapy® system. All SAEs are reported in the SAE data table, whereas only the most common AEs (> 5%) are reported in the AE data table.
214877|NCT01325532|B3|Baseline|Total|Total of all reporting groups
214878|NCT01325532|B2|Baseline|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.
Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
214879|NCT01325532|B1|Baseline|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.
Active CES: CES current"
214880|NCT01325532|P2|Participant Flow|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.
Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
214881|NCT01325532|P1|Participant Flow|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.
Active CES: CES current"
215481|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
214882|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.
Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
214883|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.
Active CES: CES current"
214884|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.
Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
214885|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.
Active CES: CES current"
214886|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.
Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
214887|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.
Active CES: CES current"
214888|NCT01325532|E2|Reported Event|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.
Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
214889|NCT01325532|E1|Reported Event|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.
Active CES: CES current"
214890|NCT01325493|B3|Baseline|Total|Total of all reporting groups
214891|NCT01325493|B2|Baseline|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214892|NCT01325493|B1|Baseline|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214893|NCT01325493|P2|Participant Flow|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214894|NCT01325493|P1|Participant Flow|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214895|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214896|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214897|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214898|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214899|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214900|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214901|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214902|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214903|NCT01325493|E2|Reported Event|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214904|NCT01325493|E1|Reported Event|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
214905|NCT01325428|B1|Baseline|Part A: Afatinib Once Daily. Part B: Afatinib+V (Vinorelbine).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent."
214906|NCT01325428|P1|Participant Flow|Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related adverse events (AEs), the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent."
214907|NCT01325428|O1|Outcome|Afatinib Once Daily (OD). Afatinib+V (Vinorelbine).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval."
214908|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
214909|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
214910|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
214911|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
214912|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
214913|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. The 95% Confidence Interval is Exact Confidence Interval.
214946|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214914|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
214915|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. The 95% Confidence Interval is Exact Confidence Interval.
214916|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
214917|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
The 95% Confidence Interval is Exact Confidence Interval."
214918|NCT01325428|E2|Reported Event|Part B: Afatinib+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.
214919|NCT01325428|E1|Reported Event|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
214920|NCT01325350|B6|Baseline|Total|Total of all reporting groups
214921|NCT01325350|B5|Baseline|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214922|NCT01325350|B4|Baseline|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214923|NCT01325350|B3|Baseline|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214924|NCT01325350|B2|Baseline|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214925|NCT01325350|B1|Baseline|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214926|NCT01325350|P5|Participant Flow|Minoxidil 2% Solution|Approximately one mL of minoxidil 2% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214927|NCT01325350|P4|Participant Flow|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214928|NCT01325350|P3|Participant Flow|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214929|NCT01325350|P2|Participant Flow|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214930|NCT01325350|P1|Participant Flow|Bimatoprost Formulation A|Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214931|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214932|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214933|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214934|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214935|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214936|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214937|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214938|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214939|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214940|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214941|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214942|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214943|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214944|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214945|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214947|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214948|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214949|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214950|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214951|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214952|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214953|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214954|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214955|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214956|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214957|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214958|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214959|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214960|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214961|NCT01325350|E5|Reported Event|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214962|NCT01325350|E4|Reported Event|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214963|NCT01325350|E3|Reported Event|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214964|NCT01325350|E2|Reported Event|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214965|NCT01325350|E1|Reported Event|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214966|NCT01325337|B6|Baseline|Total|Total of all reporting groups
214967|NCT01325337|B5|Baseline|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214968|NCT01325337|B4|Baseline|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214969|NCT01325337|B3|Baseline|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214970|NCT01325337|B2|Baseline|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214971|NCT01325337|B1|Baseline|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214972|NCT01325337|P5|Participant Flow|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214973|NCT01325337|P4|Participant Flow|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214974|NCT01325337|P3|Participant Flow|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214975|NCT01325337|P2|Participant Flow|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214976|NCT01325337|P1|Participant Flow|Bimatoprost Formulation A|Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214977|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214978|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214979|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214980|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214981|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214982|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214983|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214984|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214985|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
215482|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
214986|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214987|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214988|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214989|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214990|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214991|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214992|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214993|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214994|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
214995|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
214996|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
214997|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
214998|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
214999|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
215000|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
215001|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
215002|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
215003|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
215004|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
215005|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
215006|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
215007|NCT01325337|E5|Reported Event|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
215008|NCT01325337|E4|Reported Event|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
215009|NCT01325337|E3|Reported Event|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
215010|NCT01325337|E2|Reported Event|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
215011|NCT01325337|E1|Reported Event|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
215012|NCT01325311|B3|Baseline|Total|Total of all reporting groups
215013|NCT01325311|B2|Baseline|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215014|NCT01325311|B1|Baseline|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215015|NCT01325311|P2|Participant Flow|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215016|NCT01325311|P1|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215017|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215018|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215019|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215095|NCT01324687|O1|Outcome|Control|Group without access to telemedicine in the home for acute care issues.
215020|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215021|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215022|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215023|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215024|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215025|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215026|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215027|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215028|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215029|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215030|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215031|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215032|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215033|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215034|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215035|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215036|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215037|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215038|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215039|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215040|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215041|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215042|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215043|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215483|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
215044|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215045|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215046|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215047|NCT01325311|E2|Reported Event|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Cholecalciferol: Given PO
Genistein: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
215048|NCT01325311|E1|Reported Event|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO"
215049|NCT01325181|B3|Baseline|Total|Total of all reporting groups
215050|NCT01325181|B2|Baseline|Ranibizumab|
215051|NCT01325181|B1|Baseline|Low-fluence PDT|
215052|NCT01325181|P2|Participant Flow|Ranibizumab|
215053|NCT01325181|P1|Participant Flow|Low-fluence PDT|
215054|NCT01325181|O2|Outcome|Ranibizumab|
215055|NCT01325181|O1|Outcome|Low-fluence PDT|
215056|NCT01325181|E2|Reported Event|Ranibizumab|
215057|NCT01325181|E1|Reported Event|Low-fluence PDT|
215058|NCT01324999|B1|Baseline|Tadalafil|40 mg daily
215059|NCT01324999|P1|Participant Flow|Tadalafil|40 mg daily
215060|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
215061|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
215062|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
215063|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
215064|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
215065|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
215066|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
215067|NCT01324999|O1|Outcome|Tadalafil|40 mg daily
215068|NCT01324999|E1|Reported Event|Tadalafil|40 mg daily
215069|NCT01324947|B1|Baseline|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
215070|NCT01324947|P1|Participant Flow|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
215071|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
215072|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
215073|NCT01324947|O1|Outcome|Pomalidomide|"Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity
pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity"
215074|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
215075|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
215076|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
215077|NCT01324947|O1|Outcome|Pomalidomide|"Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity
pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity"
215078|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
215079|NCT01324947|E1|Reported Event|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
215080|NCT01324882|B3|Baseline|Total|Total of all reporting groups
215081|NCT01324882|B2|Baseline|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
215082|NCT01324882|B1|Baseline|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
215083|NCT01324882|P2|Participant Flow|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
215084|NCT01324882|P1|Participant Flow|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
215085|NCT01324882|O2|Outcome|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
215086|NCT01324882|O1|Outcome|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
215087|NCT01324882|E2|Reported Event|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
215088|NCT01324882|E1|Reported Event|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
215089|NCT01324687|B3|Baseline|Total|Total of all reporting groups
215090|NCT01324687|B2|Baseline|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.
Telemedicine care: Availability of telemedicine"
215091|NCT01324687|B1|Baseline|Control|Group without access to telemedicine in the home for acute care issues.
215092|NCT01324687|P2|Participant Flow|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.
Telemedicine care: Availability of telemedicine"
215093|NCT01324687|P1|Participant Flow|Control|Group without access to telemedicine in the home for acute care issues.
215094|NCT01324687|O2|Outcome|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.
Telemedicine care: Availability of telemedicine"
215096|NCT01324687|O2|Outcome|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.
Telemedicine care: Availability of telemedicine"
215097|NCT01324687|O1|Outcome|Control|Group without access to telemedicine in the home for acute care issues.
215098|NCT01324687|E2|Reported Event|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.
Telemedicine care: Availability of telemedicine"
215099|NCT01324687|E1|Reported Event|Control|Group without access to telemedicine in the home for acute care issues.
215100|NCT01324622|B3|Baseline|Total|Total of all reporting groups
215101|NCT01324622|B2|Baseline|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215102|NCT01324622|B1|Baseline|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215103|NCT01324622|P2|Participant Flow|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215104|NCT01324622|P1|Participant Flow|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215105|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215106|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215107|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215108|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215109|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215110|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215111|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215112|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215113|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215114|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215115|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215116|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215117|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215118|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215119|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215120|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215121|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215122|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215123|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215124|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215125|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215126|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215127|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
215128|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
215129|NCT01324622|E2|Reported Event|Laminoplasty|"Treatment group
Laminoplasty: Utilizing the ARCH Fixation System (Study device)"
215130|NCT01324622|E1|Reported Event|Laminectomy|"Control
laminectomy: standard procedure"
215131|NCT01324570|B3|Baseline|Total|Total of all reporting groups
215132|NCT01324570|B2|Baseline|12 to 16 Years|Children 12 to 16 years of age
215133|NCT01324570|B1|Baseline|7 to 11 Years|Children 7 to 11 years of age
215134|NCT01324570|P2|Participant Flow|12 to 16 Years|Children 12 to 16 years of age
215135|NCT01324570|P1|Participant Flow|7 to 11 Years|Children 7 to 11 years of age
215136|NCT01324570|O1|Outcome|Population PK Analysis Set|Children 7 to 16 years of age (reference patient with IBW of 70 kg)
215137|NCT01324570|O2|Outcome|12 to 16 Years|Children 12 to 16 years of age
215138|NCT01324570|O1|Outcome|7 to 11 Years|Children 7 to 11 years of age
215139|NCT01324570|O1|Outcome|12 to 16 Years|Children 12 to 16 years of age
215140|NCT01324570|O1|Outcome|7 to 11 Years|Children 7 to 11 years of age
215141|NCT01324570|O1|Outcome|Population PK Analysis Set|Children 7 to 16 years of age (reference patient with IBW of 70 kg)
215142|NCT01324570|O2|Outcome|12 to 16 Years|Children 12 to 16 years of age
215143|NCT01324570|O1|Outcome|7 to 11 Years|Children 7 to 11 years of age
215144|NCT01324570|E2|Reported Event|12 to 16 Years|Children 12 to 16 years of age
215145|NCT01324570|E1|Reported Event|7 to 11 Years|Children 7 to 11 years of age
215146|NCT01324440|B3|Baseline|Total|Total of all reporting groups
215147|NCT01324440|B2|Baseline|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
215148|NCT01324440|B1|Baseline|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
215149|NCT01324440|P2|Participant Flow|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
215150|NCT01324440|P1|Participant Flow|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
215151|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
215152|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
215153|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
215154|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
215155|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
215156|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
215157|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
215158|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
215159|NCT01324440|E2|Reported Event|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
215160|NCT01324440|E1|Reported Event|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
215161|NCT01324401|B3|Baseline|Total|Total of all reporting groups
215162|NCT01324401|B2|Baseline|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
215163|NCT01324401|B1|Baseline|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will have the opportunity to cross over to active therapy.
215164|NCT01324401|P2|Participant Flow|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
215165|NCT01324401|P1|Participant Flow|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
215166|NCT01324401|O2|Outcome|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
215167|NCT01324401|O1|Outcome|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
215168|NCT01324401|O2|Outcome|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
215169|NCT01324401|O1|Outcome|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
215170|NCT01324401|E2|Reported Event|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
215171|NCT01324401|E1|Reported Event|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
215172|NCT01324388|B4|Baseline|Total|Total of all reporting groups
215173|NCT01324388|B3|Baseline|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:
Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1
Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7
Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:
Treatment Sequence A: Treatment 1, Treatment 2
Treatment Sequence B: Treatment 2, Treatment 1
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
215174|NCT01324388|B2|Baseline|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215175|NCT01324388|B1|Baseline|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215176|NCT01324388|P4|Participant Flow|Part 2: LY2189265 + Metoprolol First, Then LY2189265|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 and on Day 1 of Treatment 1 in Part 2 of the study.
Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 1 in Part 2 of the study.
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 7 of Treatment 2 to Day 1 of Treatment 1 in Part 2 of the study)."
215484|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
215177|NCT01324388|P3|Participant Flow|Part 2: LY2189265 First, Then LY2189265 + Metoprolol|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 and on Day 5 of Treatment 2 in Part 2 of the study.
Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study.
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 of Treatment 1 to Day 1 of Treatment 2 in Part 2 of the study)."
215178|NCT01324388|P2|Participant Flow|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215179|NCT01324388|P1|Participant Flow|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215180|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol (Treatment 2)|"Participants received 2 treatments in Part 2 of the study:
Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1
Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 ; Metoprolol: 100 mg, oral, on Days 1 through 7
Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:
Treatment Sequence A: Treatment 1, Treatment 2
Treatment Sequence B: Treatment 2, Treatment 1
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
215181|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol (Treatment 2)|"Participants received 2 treatments in Part 2 of the study:
Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1
Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7
Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:
Treatment Sequence A: Treatment 1, Treatment 2
Treatment Sequence B: Treatment 2, Treatment 1
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
215182|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215183|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215184|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:
Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1
Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7
Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:
Treatment Sequence A: Treatment 1, Treatment 2
Treatment Sequence B: Treatment 2, Treatment 1
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
215185|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:
Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1
Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7
Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:
Treatment Sequence A: Treatment 1, Treatment 2
Treatment Sequence B: Treatment 2, Treatment 1
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
215186|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215187|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215188|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215189|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215190|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215191|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215192|NCT01324388|E5|Reported Event|Part 2: LY2189265 + Metoprolol|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 in Part 2 of the study.
Metoprolol: 100 mg, oral, on Days 5 through 7 of Treatment 2 in Part 2 of the study.
Time frame: Day 5 to end of Treatment 2"
215193|NCT01324388|E4|Reported Event|Part 2: Metoprolol|"Metoprolol: 100 milligrams (mg), oral, on Days 1 through 4 of Treatment 2 in Part 2 of the study.
Time frame: Days 1 to 4 of Treatment 2"
215194|NCT01324388|E3|Reported Event|Part 2: LY2189265|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 in Part 2 of the study.
Time frame: Treatment 1"
215195|NCT01324388|E2|Reported Event|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215485|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
215196|NCT01324388|E1|Reported Event|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
215197|NCT01324349|B3|Baseline|Total|Total of all reporting groups
215198|NCT01324349|B2|Baseline|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®
215199|NCT01324349|B1|Baseline|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
215200|NCT01324349|P2|Participant Flow|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®
215201|NCT01324349|P1|Participant Flow|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
215202|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
215203|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
215204|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
215205|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
215206|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
215207|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
215208|NCT01324349|E2|Reported Event|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
215209|NCT01324349|E1|Reported Event|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
215210|NCT01324323|B1|Baseline|Romidepsin and Rifampin|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.
Rifampin 600 mg oral once daily on Days 4-8"
215211|NCT01324323|P1|Participant Flow|Romidepsin and Rifampin|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.
Rifampin 600 mg oral once daily on Days 4-8"
215212|NCT01324323|O1|Outcome|Romidepsin Plus Rifampin|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Days 1 and 8. Rifampin 600 mg oral once daily on Days 4-8
215213|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
215214|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
215215|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
215216|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
215217|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
215218|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
215219|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
215220|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
215221|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600mg oral once daily on Days 4-8
215222|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
215223|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8.
215224|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1
215225|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
215226|NCT01324323|O1|Outcome|Romidepsin Day 1|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
Rifampin 600 mg oral once daily on Days 4-8"
215227|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600mg oral once daily on Days 4-8.
215228|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.
215229|NCT01324323|E1|Reported Event|Romidepsin Plus Rifampin|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8 and Rifampin 600 mg oral once daily on Days 4-8.
215230|NCT01324310|B1|Baseline|Romidepsin and Ketoconazole|"Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.
Ketoconazole 400 mg oral once daily on Days 4-8"
215231|NCT01324310|P1|Participant Flow|Romidepsin and Ketoconazole|"Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8
Ketoconazole 400 mg oral once daily on Days 4-8"
215232|NCT01324310|O1|Outcome|Romidepsin Plus Ketoconazole|Romidepsin 8 mg/m2 intravenous infused over 4 hours on Day 1 and Day 8. Ketoconazole 400 mg oral once daily on Days 4-8
215233|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
215234|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
215235|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
215236|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
215237|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
215238|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
215239|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
215240|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
215241|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
215242|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
215243|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
215244|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
215245|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
215246|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
215247|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
215248|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
215249|NCT01324310|E1|Reported Event|Romidepsin Plus Ketoconazole|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8. Ketoconazole 400 mg oral once daily on Days 4-8
215250|NCT01324271|B1|Baseline|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
215251|NCT01324271|P2|Participant Flow|Tympanostomy Tube Placement (Study Cohort)|Acclarent Tympanostomy Tube Delivery system (TTDS): Placement of tympanostomy tube under local anesthesia in office/clinic setting
215252|NCT01324271|P1|Participant Flow|Tympanostomy Tube Placement (Lead-In Procedures)|"Acclarent Tympanostomy Tube Delivery system (TTDS):
Placement of tympanostomy tube under local anesthesia in office/clinic setting or under general anesthesia in operating room."
215253|NCT01324271|O1|Outcome|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting
215254|NCT01324271|O1|Outcome|Tube Placement Using the TTDS in Office/Clinic Setting|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting
215255|NCT01324271|O1|Outcome|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
215256|NCT01324271|E1|Reported Event|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS).
215257|NCT01324128|B3|Baseline|Total|Total of all reporting groups
215258|NCT01324128|B2|Baseline|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
215259|NCT01324128|B1|Baseline|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
215260|NCT01324128|P4|Participant Flow|PA21-1 (LD) Stage 2|PA21-1 (1.25 g/day) Low Dose (LD) comparator for Stage 2.
215261|NCT01324128|P3|Participant Flow|PA21 (MD) Stage 2|PA21 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1
215262|NCT01324128|P2|Participant Flow|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
215263|NCT01324128|P1|Participant Flow|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
215264|NCT01324128|O2|Outcome|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
215265|NCT01324128|O1|Outcome|PA21 (2.5 g Tablet) Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
215266|NCT01324128|O2|Outcome|PA21-1 (LD) Stage 2|PA21-1 Low Dose (LD) comparator (1.25 g/day) for Stage 2
215267|NCT01324128|O1|Outcome|PA21 (MD) Stage 2|PA21 Stage 2 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.
215268|NCT01324128|E4|Reported Event|PA21 (MD) Stage 2|PA21 (2.5g tablet) Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.
215269|NCT01324128|E3|Reported Event|PA21-1 (LD) Stage 2|PA21-1 (1.25 g tablet). Low Dose (LD) comparator (1.25 g/day) for Stage 2.
215270|NCT01324128|E2|Reported Event|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
215271|NCT01324128|E1|Reported Event|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
215272|NCT01324102|B3|Baseline|Total|Total of all reporting groups
215273|NCT01324102|B2|Baseline|Wait List Control|Wait List control: The wait list control did not receive an intervention.
215274|NCT01324102|B1|Baseline|Yoga Therapy Intervention|Intervention: Yoga therapy was 8 week class for two times per week
215275|NCT01324102|P2|Participant Flow|Wait List Control|Wait List control received no intervention for 8 weeks, then joined the yoga group
215276|NCT01324102|P1|Participant Flow|Yoga Therapy Intervention|"Intervention
Yoga therapy received an 8 week 2x weekly Yoga therapy class."
215277|NCT01324102|O2|Outcome|Post Group Values|Patient Reported Outcome Measurement System values for all participants after participation in 8 session Yoga Therapy with home practice
215278|NCT01324102|O1|Outcome|Pre Group Values|Patient Reported Outcome Measurement System values for all participants prior to participation in 8 session Yoga Therapy with home practice
215279|NCT01324102|E3|Reported Event|Wait List on Yoga Therapy|"Received yoga therapy after an 8 week wait.
No participants were hospitalized."
215280|NCT01324102|E2|Reported Event|Wait List|"Received no yoga therapy for 8 weeks while the intervention group received yoga therapy
One participant in the Arm 2, Wait list, age 65, was hospitalized. His principal diagnosis was pneumonia."
215281|NCT01324102|E1|Reported Event|Yoga Therapy|"Received yoga therapy.
One participant in the Arm 1, Yoga therapy, age 80, was hospitalized. His principal diagnosis was influenza."
215282|NCT01324024|B1|Baseline|All Study Participants|Participants were randomized to receive either Lisdexampethamine in titrated doses (20mg/d- 60mg/d) or Placebo tablets (matching Lisdexamphetamine).
215283|NCT01324024|P2|Participant Flow|Placebo First, Then Lisdexamfetamine|Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks, followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks).
215284|NCT01324024|P1|Participant Flow|Lisdexamfetamine, Then Placebo|Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks) followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
215285|NCT01324024|O3|Outcome|Placebo|Participants received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
215286|NCT01324024|O2|Outcome|Lisdexamfetamine|Participants received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks (i.e, 20mg/d for 1 week, 40mg/d for 1 week and 60mg/d for 2 weeks).
215287|NCT01324024|O1|Outcome|Baseline|
215288|NCT01324024|O3|Outcome|Sugar Pill|"Placebo pill, capsules
Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
215289|NCT01324024|O2|Outcome|Lisdexamfetamine|"Lisdexamfetamine or Vyvanse
Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
215290|NCT01324024|O1|Outcome|Baseline|
215291|NCT01324024|O3|Outcome|Sugar Pill|"Placebo pill, capsules
Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
215292|NCT01324024|O2|Outcome|Lisdexamfetamine|Participants who received Lisdexamfetamine 20
215293|NCT01324024|O1|Outcome|Baseline|
215294|NCT01324024|E2|Reported Event|Sugar Pill|"Placebo pill, capsules
Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
215295|NCT01324024|E1|Reported Event|Lisdexamfetamine|"Lisdexamfetamine or Vyvanse
Lisdexamfetamine: The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo."
215296|NCT01323998|B6|Baseline|Total|Total of all reporting groups
215297|NCT01323998|B5|Baseline|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215298|NCT01323998|B4|Baseline|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215299|NCT01323998|B3|Baseline|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215300|NCT01323998|B2|Baseline|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215301|NCT01323998|B1|Baseline|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215302|NCT01323998|P5|Participant Flow|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215303|NCT01323998|P4|Participant Flow|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215304|NCT01323998|P3|Participant Flow|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215305|NCT01323998|P2|Participant Flow|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215306|NCT01323998|P1|Participant Flow|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram (mg), or a procedure code for prostate surgery
215307|NCT01323998|O5|Outcome|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215308|NCT01323998|O4|Outcome|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215309|NCT01323998|O3|Outcome|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215310|NCT01323998|O2|Outcome|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215311|NCT01323998|O1|Outcome|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215312|NCT01323998|E5|Reported Event|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215313|NCT01323998|E4|Reported Event|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215314|NCT01323998|E3|Reported Event|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215315|NCT01323998|E2|Reported Event|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215316|NCT01323998|E1|Reported Event|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
215317|NCT01323972|B5|Baseline|Total|Total of all reporting groups
215318|NCT01323972|B4|Baseline|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215319|NCT01323972|B3|Baseline|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215320|NCT01323972|B2|Baseline|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215321|NCT01323972|B1|Baseline|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215322|NCT01323972|P4|Participant Flow|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215323|NCT01323972|P3|Participant Flow|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215324|NCT01323972|P2|Participant Flow|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215325|NCT01323972|P1|Participant Flow|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215326|NCT01323972|O4|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215327|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215328|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215329|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215330|NCT01323972|O4|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215331|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215486|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
215487|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
215332|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215333|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215334|NCT01323972|O4|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215335|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215336|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215337|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215338|NCT01323972|O4|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215339|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215340|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215341|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215342|NCT01323972|O5|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215343|NCT01323972|O4|Outcome|GSK 257049-Pooled Group|This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group.
215344|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215345|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215346|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215347|NCT01323972|O5|Outcome|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215348|NCT01323972|O4|Outcome|GSK 257049-Pooled Group|This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group.
215349|NCT01323972|O3|Outcome|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215350|NCT01323972|O2|Outcome|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215351|NCT01323972|O1|Outcome|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215352|NCT01323972|E4|Reported Event|GSK 257049-Pilot Group|Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215353|NCT01323972|E3|Reported Event|GSK 257049-Lot 3 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215354|NCT01323972|E2|Reported Event|GSK 257049-Lot 2 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215428|NCT01323855|B2|Baseline|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215355|NCT01323972|E1|Reported Event|GSK 257049-Lot 1 Group|Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
215356|NCT01323959|B4|Baseline|Total|Total of all reporting groups
215357|NCT01323959|B3|Baseline|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215358|NCT01323959|B2|Baseline|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215359|NCT01323959|B1|Baseline|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215360|NCT01323959|P3|Participant Flow|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215361|NCT01323959|P2|Participant Flow|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215362|NCT01323959|P1|Participant Flow|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215363|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215364|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215365|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215366|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215367|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215368|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215369|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215370|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215371|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215372|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215373|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215374|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215375|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215376|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215377|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215429|NCT01323855|B1|Baseline|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215378|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215379|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215380|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215381|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215382|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215383|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215384|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215385|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215386|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215387|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215388|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215389|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215390|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215391|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215392|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215393|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215394|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215395|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215396|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215397|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215398|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215399|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215400|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215401|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215402|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215403|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215404|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215405|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215406|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215407|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215408|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215409|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215410|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215411|NCT01323959|O3|Outcome|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215412|NCT01323959|O2|Outcome|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215413|NCT01323959|O1|Outcome|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215414|NCT01323959|E3|Reported Event|Revaxis Group|Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215415|NCT01323959|E2|Reported Event|Boostrix+Poliorix Group|Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215416|NCT01323959|E1|Reported Event|Boostrix Polio Group|Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
215417|NCT01323920|B1|Baseline|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate
Other Names:
Velcade
Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
215418|NCT01323920|P1|Participant Flow|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate
Other Names:
Velcade
Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
215419|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate
Other Names:
Velcade
Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
215420|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate
Other Names:
Velcade
Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
215421|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate
Other Names:
Velcade
Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
215422|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate
Other Names:
Velcade
Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
215423|NCT01323920|E1|Reported Event|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate
Other Names:
Velcade
Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
215424|NCT01323855|B6|Baseline|Total|Total of all reporting groups
215425|NCT01323855|B5|Baseline|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215426|NCT01323855|B4|Baseline|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215427|NCT01323855|B3|Baseline|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215430|NCT01323855|P5|Participant Flow|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215431|NCT01323855|P4|Participant Flow|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215432|NCT01323855|P3|Participant Flow|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215433|NCT01323855|P2|Participant Flow|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215434|NCT01323855|P1|Participant Flow|Part 1: Severe Renal Impairment|Participants with severe chronic renal impairment (CRI), defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215435|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215436|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215437|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215438|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215439|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215440|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215441|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215442|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215443|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215444|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215445|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215446|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215447|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215448|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215449|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215450|NCT01323855|E5|Reported Event|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215451|NCT01323855|E4|Reported Event|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215452|NCT01323855|E3|Reported Event|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215453|NCT01323855|E2|Reported Event|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215454|NCT01323855|E1|Reported Event|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
215455|NCT01323790|B4|Baseline|Total|Total of all reporting groups
215456|NCT01323790|B3|Baseline|Placebo|Placebo QD, oral treatment
215457|NCT01323790|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
215458|NCT01323790|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
215459|NCT01323790|P3|Participant Flow|Placebo|Placebo QD, oral treatment
215460|NCT01323790|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
215461|NCT01323790|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
215462|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
215463|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
215464|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
215465|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
215466|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
215467|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
215468|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
215488|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
215489|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
215490|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
215491|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
215492|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
215493|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
215494|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
215495|NCT01323790|E3|Reported Event|Placebo|
215496|NCT01323790|E2|Reported Event|NKTR-118 25 mg|
215497|NCT01323790|E1|Reported Event|NKTR-118 12.5 mg|
215498|NCT01323777|B1|Baseline|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
215499|NCT01323777|P1|Participant Flow|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
215500|NCT01323777|O3|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
215501|NCT01323777|O2|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
215502|NCT01323777|O1|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
215503|NCT01323777|O5|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
215504|NCT01323777|O4|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
215505|NCT01323777|O3|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
215506|NCT01323777|O2|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
215507|NCT01323777|O1|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
215508|NCT01323777|E1|Reported Event|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
215509|NCT01323673|B3|Baseline|Total|Total of all reporting groups
215510|NCT01323673|B2|Baseline|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
215511|NCT01323673|B1|Baseline|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
215512|NCT01323673|P2|Participant Flow|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
215513|NCT01323673|P1|Participant Flow|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
215514|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
215515|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
215516|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
215517|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
215518|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
215519|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
215520|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
215521|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
215522|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
215523|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
215524|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
215525|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
215570|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
215526|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
215527|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
215528|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
215529|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
215530|NCT01323673|E2|Reported Event|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
215531|NCT01323673|E1|Reported Event|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
215532|NCT01323660|B1|Baseline|All Study Treatments|Participants were randomized to receive a sequence consisting of 2 of the following treatments: UMEC/VI 125/25 µg , UMEC/VI 62.5/25 µg , UMEC 125 µg , UMEC 62.5 µg , VI 25 µg , or placebo QD via a DPI. Each treatment was administered in the morning for 12 weeks. The treatment periods were seperated by 14-day washout period.
215533|NCT01323660|P6|Participant Flow|UMEC 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
215534|NCT01323660|P5|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
215535|NCT01323660|P4|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
215536|NCT01323660|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
215537|NCT01323660|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
215538|NCT01323660|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 12weeks.
215539|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
215540|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
215541|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
215542|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
215543|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
215544|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
215545|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
215546|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
215547|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
215548|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
215549|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
215550|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
215551|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
215552|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
215553|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
215554|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
215555|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
215556|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
215557|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
215558|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
215559|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
215560|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
215561|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
215562|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
215563|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
215564|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
215565|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
215566|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
215567|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
215568|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
215569|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
215571|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
215572|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
215573|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
215574|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
215575|NCT01323660|E6|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
215576|NCT01323660|E5|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
215577|NCT01323660|E4|Reported Event|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
215578|NCT01323660|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
215579|NCT01323660|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
215580|NCT01323660|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
215581|NCT01323647|B3|Baseline|Total|Total of all reporting groups
215582|NCT01323647|B2|Baseline|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
215583|NCT01323647|B1|Baseline|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
215584|NCT01323647|P2|Participant Flow|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
215585|NCT01323647|P1|Participant Flow|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
215586|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
215587|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
215588|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
215589|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
215590|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
215591|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
215592|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
215593|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
215594|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
215595|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
215596|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
215597|NCT01323647|E2|Reported Event|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
215598|NCT01323647|E1|Reported Event|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
215599|NCT01323634|B3|Baseline|Total|Total of all reporting groups
215600|NCT01323634|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
215601|NCT01323634|B1|Baseline|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
215602|NCT01323634|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
215603|NCT01323634|P2|Participant Flow|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
215669|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody Fusion with Anterior Plating
215604|NCT01323634|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
215605|NCT01323634|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
215606|NCT01323634|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
215607|NCT01323634|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
215608|NCT01323634|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
215609|NCT01323634|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
215610|NCT01323634|E1|Reported Event|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
215611|NCT01323621|B3|Baseline|Total|Total of all reporting groups
215612|NCT01323621|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
215613|NCT01323621|B1|Baseline|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
215614|NCT01323621|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
215615|NCT01323621|P2|Participant Flow|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
215616|NCT01323621|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, Ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
215617|NCT01323621|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
215618|NCT01323621|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
215619|NCT01323621|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
215620|NCT01323621|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
215621|NCT01323621|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
215670|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody fusions with Anterior Plating
215671|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody fusions with Anterior Plating
215622|NCT01323621|E1|Reported Event|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
215623|NCT01323595|B3|Baseline|Total|Total of all reporting groups
215624|NCT01323595|B2|Baseline|Sugar Pill|"Sugar pill for 6 days after surgery.
Sugar Pill : Sugar pill PO BID x 6 days"
215625|NCT01323595|B1|Baseline|Celecoxib|"Celecoxib will be given for 6 days after surgery
Celecoxib : Celecoxib 200mg PO BID x 6 days"
215626|NCT01323595|P2|Participant Flow|Sugar Pill|"Sugar pill for 5 days after surgery.
Sugar Pill : Sugar pill PO BID x 6 days"
215627|NCT01323595|P1|Participant Flow|Celecoxib|"Celecoxib will be given for 5 days after surgery
Celecoxib : Celecoxib 200mg PO BID x 6 days"
215628|NCT01323595|O2|Outcome|Celecoxib|
215629|NCT01323595|O1|Outcome|Placebo Treatment|
215630|NCT01323595|E2|Reported Event|Celecoxib|
215631|NCT01323595|E1|Reported Event|Placebo Treatment|
215632|NCT01323582|B3|Baseline|Total|Total of all reporting groups
215633|NCT01323582|B2|Baseline|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
215634|NCT01323582|B1|Baseline|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
215635|NCT01323582|P2|Participant Flow|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
215636|NCT01323582|P1|Participant Flow|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
215637|NCT01323582|O1|Outcome|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
215638|NCT01323582|O1|Outcome|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.
Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
215639|NCT01323582|O1|Outcome|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
215640|NCT01323582|O1|Outcome|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.
Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
215641|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
215642|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
215643|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
215644|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
215645|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
215646|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
215647|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
215648|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
215649|NCT01323582|E2|Reported Event|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
215650|NCT01323582|E1|Reported Event|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.
Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
215651|NCT01323478|B1|Baseline|Vortioxetine 15 or 20 mg/Day|
215652|NCT01323478|P1|Participant Flow|Vortioxetine 15 or 20 mg/Day|
215653|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
215654|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
215655|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
215656|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
215657|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
215658|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
215659|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
215660|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
215661|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
215662|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
215663|NCT01323478|E1|Reported Event|Vortioxetine 15 or 20 mg/Day|
215664|NCT01323387|B1|Baseline|Treatment|Interbody fusions with Anterior Plating
215665|NCT01323387|P1|Participant Flow|Anterior Lumbar Interbody Fusion|Interbody fusions with Anterior Plating
215666|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody fusions with Anterior Plating
215667|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody Fusion with Anterior Plating
215668|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody Fusion with Anterior Plating
215672|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody Fusion with Anterior Plating
215673|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody fusions with Anterior Plating
215674|NCT01323387|E1|Reported Event|Treatment|"Interbody fusions with Anterior Plating
Interbody Fusion: allograft spacer + anterior plate"
215675|NCT01323270|B3|Baseline|Total|Total of all reporting groups
215676|NCT01323270|B2|Baseline|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
215677|NCT01323270|B1|Baseline|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
215678|NCT01323270|P2|Participant Flow|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
215679|NCT01323270|P1|Participant Flow|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
215680|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
215681|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
215682|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
215683|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
215684|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
215685|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
215686|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
215687|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
215688|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month
215689|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
215690|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
215691|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
215692|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
215693|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
215694|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
215695|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
215696|NCT01323270|E2|Reported Event|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
215697|NCT01323270|E1|Reported Event|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
215698|NCT01323192|B3|Baseline|Total|Total of all reporting groups
215699|NCT01323192|B2|Baseline|Placebo|Participants received matching placebo orally once daily for 8 weeks.
215700|NCT01323192|B1|Baseline|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
215701|NCT01323192|P2|Participant Flow|Placebo|Participants received matching placebo orally once daily for 8 weeks.
215702|NCT01323192|P1|Participant Flow|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
215703|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
215704|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
215705|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
215706|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
215707|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
215708|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
215709|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
215710|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
215711|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
215712|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
215713|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
215714|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
215715|NCT01323192|E2|Reported Event|Placebo|Participants received matching placebo orally once daily for 8 weeks.
215716|NCT01323192|E1|Reported Event|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
215717|NCT01323140|B1|Baseline|Treatment|
215718|NCT01323140|P1|Participant Flow|Treatment|
215719|NCT01323140|O1|Outcome|Treatment|As specified in the Protocol, subjects were dose-titrated during treatment and subjects at all resulting dose levels were pooled for primary efficacy analysis. After dose-titration, 20 subjects were receiving TMTS at dose level B (one 48 cm2 TMTS) and 18 subjects were receiving TMTS at dose level C (one 48 cm2 and one 28 cm2 TMTS). See also Arm description.
215720|NCT01323140|E1|Reported Event|Treatment|
215721|NCT01323010|B3|Baseline|Total|Total of all reporting groups
215722|NCT01323010|B2|Baseline|Control Group|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215805|NCT01322841|O1|Outcome|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on
CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
215723|NCT01323010|B1|Baseline|Experimental Group|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215724|NCT01323010|P2|Participant Flow|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215725|NCT01323010|P1|Participant Flow|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215726|NCT01323010|O3|Outcome|Arg16Arg Patients|Patients carrying the Arg16Arg genotype
215727|NCT01323010|O2|Outcome|Gly16Gly Patients|Patients carrying the Gly16Gly genotype
215728|NCT01323010|O1|Outcome|Arg16Gly Patients|Patients carrying the Arg16Gly genotype
215729|NCT01323010|O2|Outcome|No Rhinovirus Detected|patients with no rhinovirus detected by PCR
215730|NCT01323010|O1|Outcome|Rhinovirus Detected|patients with rhinovirus detected by PCR
215731|NCT01323010|O2|Outcome|No Virus Detected|patients with no virus detected by PCR
215732|NCT01323010|O1|Outcome|Virus Detected|patients with any virus detected by PCR
215733|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215734|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215735|NCT01323010|O2|Outcome|Control Group|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215736|NCT01323010|O1|Outcome|Experimental Group|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215737|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215738|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215739|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215740|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215741|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215742|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215743|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215744|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215745|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215746|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215747|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215748|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215749|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
216032|NCT01321749|P2|Participant Flow|Stroke Secondary Prevention|Procedure:stroke secondary prevention
215750|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215751|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215752|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215753|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215754|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215755|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215756|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215757|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215758|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215759|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215760|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215761|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215762|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215763|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215764|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215765|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215766|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215767|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was individualized according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215768|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215769|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215770|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215771|NCT01323010|E2|Reported Event|Control Group|"Dosing was dived according to consensus recommendations in only two categories according to body weight
Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
215806|NCT01322841|O2|Outcome|CHICA Placebo|"This arm had CHICA but no additional module
CHICA Placebo: This was CHICA without the screening module"
216497|NCT01319500|O3|Outcome|Gynecologists (Public Practice Only)|Gynecologists in public practice only
215772|NCT01323010|E1|Reported Event|Experimental Group|"Dosing was individualized in four categories according to body weight
Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
215773|NCT01322971|B3|Baseline|Total|Total of all reporting groups
215774|NCT01322971|B2|Baseline|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm
Placebo: Placebo will be administered orally twice daily for seven days"
215775|NCT01322971|B1|Baseline|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.
Metronidazole: Metronidazole 500mg orally twice daily for seven days"
215776|NCT01322971|P2|Participant Flow|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm
Placebo: Placebo will be administered orally twice daily for seven days"
215777|NCT01322971|P1|Participant Flow|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.
Metronidazole: Metronidazole 500mg orally twice daily for seven days"
215778|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm
Placebo: Placebo will be administered orally twice daily for seven days"
215779|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.
Metronidazole: Metronidazole 500mg orally twice daily for seven days"
215780|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm
Placebo: Placebo will be administered orally twice daily for seven days"
215781|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.
Metronidazole: Metronidazole 500mg orally twice daily for seven days"
215782|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm
Placebo: Placebo will be administered orally twice daily for seven days"
215783|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.
Metronidazole: Metronidazole 500mg orally twice daily for seven days"
215784|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm
Placebo: Placebo will be administered orally twice daily for seven days"
215785|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.
Metronidazole: Metronidazole 500mg orally twice daily for seven days"
215786|NCT01322971|E2|Reported Event|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm
Placebo: Placebo will be administered orally twice daily for seven days"
215787|NCT01322971|E1|Reported Event|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.
Metronidazole: Metronidazole 500mg orally twice daily for seven days"
215788|NCT01322945|B3|Baseline|Total|Total of all reporting groups
215789|NCT01322945|B2|Baseline|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
215790|NCT01322945|B1|Baseline|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
215791|NCT01322945|P2|Participant Flow|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
215792|NCT01322945|P1|Participant Flow|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
215793|NCT01322945|O2|Outcome|Control Group|First 10 patients enrolled undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
215794|NCT01322945|O1|Outcome|Endonasal Group|First 12 patients enrolled undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
215795|NCT01322945|O2|Outcome|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
215796|NCT01322945|O1|Outcome|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
215797|NCT01322945|E2|Reported Event|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
215798|NCT01322945|E1|Reported Event|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
215799|NCT01322841|B3|Baseline|Total|Total of all reporting groups
215800|NCT01322841|B2|Baseline|CHICA Placebo|This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
215801|NCT01322841|B1|Baseline|CHICA Diagnosis Module|This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
215802|NCT01322841|P2|Participant Flow|CHICA Placebo|This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
215803|NCT01322841|P1|Participant Flow|CHICA Diagnosis Module|This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
215804|NCT01322841|O2|Outcome|CHICA Placebo|"This arm had CHICA but no additional module
CHICA Placebo: This was CHICA without the screening module"
215807|NCT01322841|O1|Outcome|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on
CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
215808|NCT01322841|E2|Reported Event|CHICA Placebo|"This arm had CHICA but no additional module
CHICA Placebo: This was CHICA without the screening module"
215809|NCT01322841|E1|Reported Event|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on
CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
215810|NCT01322815|B3|Baseline|Total|Total of all reporting groups
215811|NCT01322815|B2|Baseline|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy
GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
215812|NCT01322815|B1|Baseline|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks"
215813|NCT01322815|P2|Participant Flow|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy
GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
215814|NCT01322815|P1|Participant Flow|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks"
215815|NCT01322815|O2|Outcome|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy
GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
215816|NCT01322815|O1|Outcome|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks"
215817|NCT01322815|E2|Reported Event|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy
GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
215818|NCT01322815|E1|Reported Event|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks"
215819|NCT01322633|B3|Baseline|Total|Total of all reporting groups
215820|NCT01322633|B2|Baseline|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
215821|NCT01322633|B1|Baseline|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
215822|NCT01322633|P2|Participant Flow|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
215823|NCT01322633|P1|Participant Flow|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
215824|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
215825|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
215826|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
215827|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
215861|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
216498|NCT01319500|O2|Outcome|Gynecologists (Private Practice Only)|Gynecologists in private practice only
215828|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
215829|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
215830|NCT01322633|E2|Reported Event|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
215831|NCT01322633|E1|Reported Event|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
215832|NCT01322607|B3|Baseline|Total|Total of all reporting groups
215833|NCT01322607|B2|Baseline|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
215834|NCT01322607|B1|Baseline|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program"
215835|NCT01322607|P2|Participant Flow|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
215836|NCT01322607|P1|Participant Flow|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program"
215837|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
215838|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program"
215839|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
215840|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program"
215841|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
215842|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program"
215843|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
215844|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program"
215845|NCT01322607|E2|Reported Event|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
215846|NCT01322607|E1|Reported Event|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program"
215847|NCT01322594|B7|Baseline|Total|Total of all reporting groups
215848|NCT01322594|B6|Baseline|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215849|NCT01322594|B5|Baseline|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215850|NCT01322594|B4|Baseline|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215851|NCT01322594|B3|Baseline|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215852|NCT01322594|B2|Baseline|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215853|NCT01322594|B1|Baseline|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215854|NCT01322594|P6|Participant Flow|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215855|NCT01322594|P5|Participant Flow|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215856|NCT01322594|P4|Participant Flow|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215857|NCT01322594|P3|Participant Flow|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215858|NCT01322594|P2|Participant Flow|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215859|NCT01322594|P1|Participant Flow|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215860|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215862|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215863|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215864|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215865|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215866|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215867|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215868|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215869|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215870|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215871|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215872|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215873|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215874|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215875|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215876|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215877|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215878|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215879|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215880|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215881|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215882|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215883|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215884|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215885|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215886|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215887|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215888|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215889|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215890|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215891|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215892|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215893|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215894|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215895|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215896|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215897|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215898|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215899|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215900|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215901|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215902|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215903|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215904|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215905|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215906|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215907|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215908|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215909|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215910|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215911|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215912|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215913|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215914|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215915|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215916|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215917|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215918|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215919|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215920|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215921|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215922|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215923|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215924|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215925|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215926|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215927|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215928|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215929|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215930|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
215931|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
215932|NCT01322594|E6|Reported Event|MEDI2338 1000 MG|
215933|NCT01322594|E5|Reported Event|MEDI2338 300 MG|
215934|NCT01322594|E4|Reported Event|MEDI2338 100 MG|
215935|NCT01322594|E3|Reported Event|MEDI2338 30 MG|
215936|NCT01322594|E2|Reported Event|MEDI2338 10 MG|
215937|NCT01322594|E1|Reported Event|Placebo|
215938|NCT01322386|B3|Baseline|Total|Total of all reporting groups
215939|NCT01322386|B2|Baseline|Oral Vancomycin - PSC|Enrolled- 11, Participated - 10 ,Completed - 9 (Based on Annual Progress Report in Oct 2010)
215940|NCT01322386|B1|Baseline|Oral Vancomycin-BIliary Atresia|Enrolled- 10, Participated - 10,Completed - 10 (Based on Annual Progress Report in Oct 2010)
215941|NCT01322386|P2|Participant Flow|Oral Vancomycin/ Primary Sclerosing Cholangitis|Vancomycin: Oral 50mg/Kg per day up to maximum of 1500 mg a day for three months. Initially 10 children with Primary Sclerosing Cholangitis (PSC) were planned for this study to determine if there was clinical response to oral vancomycin.
215942|NCT01322386|P1|Participant Flow|Oral Vancomycin-Biliary Atresia|Vancomycin: Oral 50mg/Kg per day for three months. Initially 10 infants with Biliary Atresia (BA) were planned for this study to determine if there was clinical response to oral vancomycin.
215943|NCT01322386|O5|Outcome|Liver Biopsy and/or MRI|BA-N/A , PSC- 8/9 participants showed improvement of liver biopsies and/or MRI on Vancomycin.
215944|NCT01322386|O4|Outcome|Colon Biopsies|BA - N/A , PSC - 8/8- who had colonoscopies with colon biopsies showed improvement on Vancomycin therapy.
215945|NCT01322386|O3|Outcome|Liver Biopsy|BA - N/A , PSC - 4/4 who had Liver biopsies showed improvement on Vancomycin therapy.
215946|NCT01322386|O2|Outcome|MRI / MRCP|BA-N/A, PSC - 7/7 showed improvement on Vancomycin therapy.
215947|NCT01322386|O1|Outcome|Liver Blood Test|BA -10/10 , PSC - 9/9 - All had improvement on Vancomycin therapy.
215948|NCT01322386|E1|Reported Event|BA/PSC -Oral Vancomycin|Oral Vancomycin is commercially available (Vancocin, ViroPharma Inc.) for treatment of gastrointestinal infection such as, Clostridium difficile infection. In fact, our published observation of using oral vancomycin in treating PSC was an incidental finding to our treatment for Cl. Difficile gastrointestinal infection in a child with PSC (J Pediatr Gastroenterol Nutr 27:580-3, 1998). Since oral vancomycin is poorly absorbed, no serious adverse events were anticipated in this study.
215949|NCT01322360|B1|Baseline|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
215950|NCT01322360|P1|Participant Flow|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
215951|NCT01322360|O1|Outcome|Morphine Sulfate|"oral solution (10 mg/5 mL or 20 mg/5 mL) or tablets (15 mg or 30 mg)given based on based on the current pediatric prescribing guidelines
Morphine Sulfate"
215952|NCT01322360|O1|Outcome|Morphine Sulfate|Subjects received morphine sulfate either as oral solution or tablet.
215953|NCT01322360|E1|Reported Event|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
215954|NCT01322347|B3|Baseline|Total|Total of all reporting groups
215955|NCT01322347|B2|Baseline|Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215956|NCT01322347|B1|Baseline|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215957|NCT01322347|P2|Participant Flow|Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215958|NCT01322347|P1|Participant Flow|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215959|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215960|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215961|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215962|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215963|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215964|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215965|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215966|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215967|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215968|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215969|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215970|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215971|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215972|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215973|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215974|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215975|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215976|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215977|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215978|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215979|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215980|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215981|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215982|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215983|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215984|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215985|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215986|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215987|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
215988|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
215989|NCT01322347|E3|Reported Event|Stage 3 Soluble Ferric Pyrophosphate (SFP)|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3)."
215990|NCT01322347|E2|Reported Event|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
215991|NCT01322347|E1|Reported Event|Stage 2 Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
215992|NCT01322048|B3|Baseline|Total|Total of all reporting groups
215993|NCT01322048|B2|Baseline|Placebo|"Placebo
Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
215994|NCT01322048|B1|Baseline|Adrenergic Blockade|"Propranolol and Clonidine
IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
215995|NCT01322048|P2|Participant Flow|Placebo|"Placebo
Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
215996|NCT01322048|P1|Participant Flow|Adrenergic Blockade|"Propranolol and Clonidine
IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
215997|NCT01322048|O2|Outcome|Placebo|"Placebo
Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
215998|NCT01322048|O1|Outcome|Adrenergic Blockade|"Propranolol and Clonidine
IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
215999|NCT01322048|O2|Outcome|Placebo|"Placebo
Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
216000|NCT01322048|O1|Outcome|Adrenergic Blockade|"Propranolol and Clonidine
IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
216001|NCT01322048|E2|Reported Event|Placebo|"Placebo
Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
216002|NCT01322048|E1|Reported Event|Adrenergic Blockade|"Propranolol and Clonidine
IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
216003|NCT01322022|B3|Baseline|Total|Total of all reporting groups
216004|NCT01322022|B2|Baseline|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
216005|NCT01322022|B1|Baseline|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
216006|NCT01322022|P2|Participant Flow|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
216007|NCT01322022|P1|Participant Flow|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
216008|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
216009|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
216010|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
216011|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
216012|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
216013|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
216014|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
216015|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
216016|NCT01322022|E2|Reported Event|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
216017|NCT01322022|E1|Reported Event|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
216018|NCT01322009|B3|Baseline|Total|Total of all reporting groups
216019|NCT01322009|B2|Baseline|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.
Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
216020|NCT01322009|B1|Baseline|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.
Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
216021|NCT01322009|P2|Participant Flow|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.
Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
216022|NCT01322009|P1|Participant Flow|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.
Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
216023|NCT01322009|O2|Outcome|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.
Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
216024|NCT01322009|O1|Outcome|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.
Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
216025|NCT01322009|O2|Outcome|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.
Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
216026|NCT01322009|O1|Outcome|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.
Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
216027|NCT01322009|E2|Reported Event|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.
Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
216028|NCT01322009|E1|Reported Event|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.
Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
216029|NCT01321749|B3|Baseline|Total|Total of all reporting groups
216030|NCT01321749|B2|Baseline|Stroke Secondary Prevention|Procedure:stroke secondary prevention
216031|NCT01321749|B1|Baseline|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.
Procedure:stroke secondary prevention"
216033|NCT01321749|P1|Participant Flow|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.
Procedure:stroke secondary prevention"
216034|NCT01321749|O2|Outcome|Stroke Secondary Prevention|Procedure:stroke secondary prevention
216035|NCT01321749|O1|Outcome|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.
Procedure:stroke secondary prevention"
216036|NCT01321749|E2|Reported Event|Stroke Secondary Prevention|Procedure:stroke secondary prevention
216037|NCT01321749|E1|Reported Event|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.
Procedure:stroke secondary prevention"
216038|NCT01321723|B4|Baseline|Total|Total of all reporting groups
216039|NCT01321723|B3|Baseline|Placebo|Placebo : matching tablets, once daily
216040|NCT01321723|B2|Baseline|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
216041|NCT01321723|B1|Baseline|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
216042|NCT01321723|P3|Participant Flow|Placebo|Placebo : matching tablets, once daily
216043|NCT01321723|P2|Participant Flow|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily.
216044|NCT01321723|P1|Participant Flow|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily.
216045|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
216046|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
216047|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
216048|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
216049|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
216050|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
216051|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
216052|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
216053|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
216054|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
216055|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
216056|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
216057|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
216058|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
216059|NCT01321723|E3|Reported Event|Placebo|Placebo : matching tablets, once daily
216060|NCT01321723|E2|Reported Event|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
216061|NCT01321723|E1|Reported Event|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
216062|NCT01321710|B4|Baseline|Total|Total of all reporting groups
216063|NCT01321710|B3|Baseline|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.
Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
216064|NCT01321710|B2|Baseline|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.
Infants in this arm receive standard immunization care."
216065|NCT01321710|B1|Baseline|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.
Infants in this arm receive standard immunization care."
216066|NCT01321710|P3|Participant Flow|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.
Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
216067|NCT01321710|P2|Participant Flow|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.
Infants in this arm receive standard immunization care."
216068|NCT01321710|P1|Participant Flow|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.
Infants in this arm receive standard immunization care."
216069|NCT01321710|O2|Outcome|Prophylactic Acetaminophen|Infants in this group received prophylactic acetaminophen administered prior to immunization and 4 subsequent doses administered in the 24 hours following immunization.
216070|NCT01321710|O1|Outcome|Standard Immunization Care|Infants in this group received standard immunization care from their health care provider (may or may not have included prophylactic acetaminophen).
216071|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information.
216072|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
216073|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information.
216074|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
216075|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information
216076|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
216077|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information
216078|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
216079|NCT01321710|E3|Reported Event|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.
Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
216143|NCT01320943|O1|Outcome|Stop TDF (TDF-Free)|Participants who stopped TDF monotherapy at baseline. Participants in this group were TDF free.
216080|NCT01321710|E2|Reported Event|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.
Infants in this arm receive standard immunization care."
216081|NCT01321710|E1|Reported Event|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.
Infants in this arm receive standard immunization care."
216082|NCT01321697|B1|Baseline|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
216083|NCT01321697|P1|Participant Flow|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
216084|NCT01321697|O1|Outcome|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
216085|NCT01321697|E1|Reported Event|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
216086|NCT01320553|B5|Baseline|Total|Total of all reporting groups
216087|NCT01320553|B4|Baseline|Placebo|"Placebo eye drops (solution)will be administered in both eyes at 3 occasions
Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
216088|NCT01320553|B3|Baseline|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
216089|NCT01320553|B2|Baseline|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
216090|NCT01320553|B1|Baseline|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions
1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
216091|NCT01320553|P4|Participant Flow|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions
Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
216092|NCT01320553|P3|Participant Flow|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
216093|NCT01320553|P2|Participant Flow|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
216094|NCT01320553|P1|Participant Flow|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions
1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
216095|NCT01320553|O4|Outcome|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions
Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
216096|NCT01320553|O3|Outcome|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
216097|NCT01320553|O2|Outcome|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
216098|NCT01320553|O1|Outcome|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions
1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
216099|NCT01320553|O4|Outcome|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions
Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
216100|NCT01320553|O3|Outcome|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
216101|NCT01320553|O2|Outcome|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
216102|NCT01320553|O1|Outcome|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions
1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
216103|NCT01320553|E4|Reported Event|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions
Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
216104|NCT01320553|E3|Reported Event|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
216105|NCT01320553|E2|Reported Event|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
216106|NCT01320553|E1|Reported Event|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions
1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
216107|NCT01321554|B3|Baseline|Total|Total of all reporting groups
216108|NCT01321554|B2|Baseline|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216109|NCT01321554|B1|Baseline|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216110|NCT01321554|P4|Participant Flow|Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. The starting dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The starting dose was lowered at the request of the Data Monitoring Committee to 20mg on 16 Feb 2013.
216144|NCT01320943|O2|Outcome|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
216111|NCT01321554|P3|Participant Flow|Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib
216112|NCT01321554|P2|Participant Flow|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216113|NCT01321554|P1|Participant Flow|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216114|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216115|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216116|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216117|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216118|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216119|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216120|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216121|NCT01321554|E4|Reported Event|Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. The starting dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The starting dose was lowered at the request of the Data Monitoring Committee to 20 mg on 16 Feb 2013.
216122|NCT01321554|E3|Reported Event|Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib
216123|NCT01321554|E2|Reported Event|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216124|NCT01321554|E1|Reported Event|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
216125|NCT01321008|B1|Baseline|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
216126|NCT01321008|P1|Participant Flow|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
216127|NCT01321008|O1|Outcome|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
216128|NCT01321008|E1|Reported Event|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
216129|NCT01320943|B3|Baseline|Total|Total of all reporting groups
216130|NCT01320943|B2|Baseline|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
216131|NCT01320943|B1|Baseline|Stop TDF|Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline.
216132|NCT01320943|P2|Participant Flow|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
216133|NCT01320943|P1|Participant Flow|Stop TDF|Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline.
216134|NCT01320943|O2|Outcome|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
216135|NCT01320943|O1|Outcome|Stop TDF|Participants stopped TDF monotherapy at baseline.
216136|NCT01320943|O2|Outcome|Re-Start TDF|Stop TDF participants who restarted TDF therapy
216137|NCT01320943|O1|Outcome|Stop TDF (TDF-Free)|Participants who stopped TDF monotherapy at baseline. Participants in this group were TDF free.
216138|NCT01320943|O2|Outcome|Re-Start TDF|Stop TDF participants who restarted TDF therapy
216139|NCT01320943|O1|Outcome|Stop TDF (TDF-Free)|Participants stopped TDF monotherapy at baseline. Participants in this group were TDF free.
216140|NCT01320943|O1|Outcome|Stop TDF|Participants stopped TDF monotherapy at baseline.
216141|NCT01320943|O3|Outcome|Continue TDF|Participants who continued TDF monotherapy 300 mg once daily.
216142|NCT01320943|O2|Outcome|Restart TDF|Stop TDF participants who restarted TDF therapy
216145|NCT01320943|O1|Outcome|Stop TDF|Participants stopped tenofovir disoproxil fumarate monotherapy at baseline.
216146|NCT01320943|O2|Outcome|Continue TDF|Participants continued TDF monotherapy 300 mg once daily.
216147|NCT01320943|O1|Outcome|Stop TDF|Participants stopped tenofovir disoproxil fumarate monotherapy at baseline.
216148|NCT01320943|E3|Reported Event|Continue TDF [TDF Emergent]|Participants continued TDF monotherapy 300 mg once daily.
216149|NCT01320943|E2|Reported Event|Re-start TDF [TDF Emergent]|Stop TDF participants who restarted TDF therapy.
216150|NCT01320943|E1|Reported Event|Stop TDF (TDF-Free) [Termination Emergent]|Participants stopped TDF monotherapy at baseline.
216151|NCT01320826|B1|Baseline|Participants.|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
216152|NCT01320826|P1|Participant Flow|Patients Undergoing Colonoscopy|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
216153|NCT01320826|O1|Outcome|Percentage of Females ≥ 50 Years With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.
For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy."
216154|NCT01320826|O1|Outcome|Percentage of Patients Referred to a Specialist.|The percentage of patients who, after having a colonoscopy, are referred to another specialist for their gastrointestinal problem. A specialist was defined as a physician more specialized than the person performing the colonoscopy, and a referral was counted if the physician, at the time of colonoscopy, sent or anticipated sending the patient to a specialist for any reason, or if the patient believed they were being sent to a specialist.
216155|NCT01320826|O1|Outcome|Procedural Time|Procedural time was defined as the time from the first insertion of the colonoscope until it was removed from the anus, in minutes
216156|NCT01320826|O1|Outcome|Patient Satisfaction With Hospital Experience|Patient satisfaction with hospital experience measured on 7 point Likert scale. 7 is extremely satisfied, 1 is extremely dissatisfied.
216157|NCT01320826|O1|Outcome|Patient Wait Time Satisfaction|"Patient satisfaction with endoscopy wait time will be recorded using a 7 point Likert scale at the time of the patient phone survey. 7 is extremely satisfied and 1 is extremely dissatisfied
minimum score = 1 maximum score = 7"
216158|NCT01320826|O1|Outcome|Patient Comfort During Colonoscopy|Patient discomfort on 5 point scale 0 is no discomfort; 1 is one or two episodes of discomfort, well tolerated; 2 is more than two episodes of discomfort adequately tolerated; 3 is significant discomfort experienced several times during the procedure; 4 is extreme discomfort experienced frequency throughout the procedure.
216159|NCT01320826|O1|Outcome|Withdraw Times, Minutes|
216160|NCT01320826|O1|Outcome|Colonoscopy Complications|"Potential serious complications of colonoscopy include bleeding, perforation, cardiopulmonary complications secondary to conscious sedation and death.
Potential serious complications will be determined from the case report form (physician reported) and at patient satisfaction phone survey (on average four weeks after colonoscopy).
All potential serious complications of colonoscopy will be externally adjudicated."
216161|NCT01320826|O1|Outcome|Percentage of Males 50 Years and Older Undergoing First Time c|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.
For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy."
216162|NCT01320826|O1|Outcome|Adenoma Detection Ratio|The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.
216163|NCT01320826|O1|Outcome|Percentage of Successful Cecal Intubations|The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)
216164|NCT01320826|O1|Outcome|Percentage of Successful Cecal Intubations (Crude)|The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
216165|NCT01320826|E1|Reported Event|Participants.|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
216166|NCT01320735|B1|Baseline|Advanced PCa|Participants with advanced PCa
216167|NCT01320735|P1|Participant Flow|Advanced Prostate Cancer (PCa)|Participants with advanced PCa
216168|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216169|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216170|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216171|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216172|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216173|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216174|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216175|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216176|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216177|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216178|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216179|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216180|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216181|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
216182|NCT01320735|E1|Reported Event|Advanced PCa|Participants with advanced PCa
216183|NCT01320722|B6|Baseline|Total|Total of all reporting groups
216184|NCT01320722|B5|Baseline|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
216185|NCT01320722|B4|Baseline|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
216499|NCT01319500|O1|Outcome|Gynecologists (All)|All gynecologists (private and public)
216186|NCT01320722|B3|Baseline|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
216187|NCT01320722|B2|Baseline|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
216188|NCT01320722|B1|Baseline|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
216189|NCT01320722|P5|Participant Flow|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
216190|NCT01320722|P4|Participant Flow|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
216191|NCT01320722|P3|Participant Flow|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
216192|NCT01320722|P2|Participant Flow|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
216193|NCT01320722|P1|Participant Flow|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
216194|NCT01320722|O5|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
216195|NCT01320722|O4|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
216196|NCT01320722|O3|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
216197|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
216198|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
216199|NCT01320722|O5|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
216200|NCT01320722|O4|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
216201|NCT01320722|O3|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
216202|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
216203|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
216204|NCT01320722|O5|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
216205|NCT01320722|O4|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
216206|NCT01320722|O3|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
216207|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
216208|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
216209|NCT01320722|O3|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
216210|NCT01320722|O2|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
216211|NCT01320722|O1|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
216212|NCT01320722|O3|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
216213|NCT01320722|O2|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
216214|NCT01320722|O1|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
216215|NCT01320722|O3|Outcome|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
216216|NCT01320722|O2|Outcome|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
216217|NCT01320722|O1|Outcome|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
216218|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
216219|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
216220|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
216221|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
216222|NCT01320722|O2|Outcome|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
216223|NCT01320722|O1|Outcome|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
216224|NCT01320722|E5|Reported Event|Placebo- Uric Acid|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
216225|NCT01320722|E4|Reported Event|Allopurinol|Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
216226|NCT01320722|E3|Reported Event|Probenecid|Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
216227|NCT01320722|E2|Reported Event|Placebo- Vitamin D|Placebo soft gel once per week for 8 weeks.
216228|NCT01320722|E1|Reported Event|Vitamin D|Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
216246|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216500|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
216229|NCT01320683|B1|Baseline|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
216230|NCT01320683|P1|Participant Flow|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
216231|NCT01320683|O1|Outcome|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
216232|NCT01320683|O1|Outcome|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
216233|NCT01320683|E1|Reported Event|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
216234|NCT01320293|B1|Baseline|Adalimumab|"active
Adalimumab: 40mg subcutaneously, every other week for 6 months"
216235|NCT01320293|P1|Participant Flow|Adalimumab|"active
Adalimumab: 40mg subcutaneously, every other week for 6 months"
216236|NCT01320293|O1|Outcome|Adalimumab|"active
Adalimumab: 40mg subcutaneously, every other week for 6 months"
216237|NCT01320293|O1|Outcome|Adalimumab|"active
Adalimumab: 40mg subcutaneously, every other week for 6 months"
216238|NCT01320293|O1|Outcome|Adalimumab|"active
Adalimumab: 40mg subcutaneously, every other week for 6 months"
216239|NCT01320293|E1|Reported Event|Adalimumab|"active
Adalimumab: 40mg subcutaneously, every other week for 6 months"
216240|NCT01320202|B3|Baseline|Total|Total of all reporting groups
216241|NCT01320202|B2|Baseline|Standard Dialysate|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 18 months."
216242|NCT01320202|B1|Baseline|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months."
216243|NCT01320202|P2|Participant Flow|Standard Dialysate|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
216244|NCT01320202|P1|Participant Flow|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
216245|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216247|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
216248|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
216249|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
216250|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
216251|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216252|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216253|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216254|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216255|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216256|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216257|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216258|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216259|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216260|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216261|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216262|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216263|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216264|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216265|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216266|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
216267|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
216268|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
216269|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
216270|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
216271|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
216272|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
216355|NCT01319812|B1|Baseline|Astron Stent Group|Subjects implanted with an Astron stent.
216273|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
216274|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
216275|NCT01320202|E3|Reported Event|Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3)."
216276|NCT01320202|E2|Reported Event|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.
Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
216277|NCT01320202|E1|Reported Event|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
216278|NCT01320137|B3|Baseline|Total|Total of all reporting groups
216279|NCT01320137|B2|Baseline|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
216280|NCT01320137|B1|Baseline|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
216281|NCT01320137|P2|Participant Flow|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
216282|NCT01320137|P1|Participant Flow|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
216283|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
216284|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
216285|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
216286|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
216287|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
216288|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
216289|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
216290|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
216291|NCT01320137|E2|Reported Event|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
216292|NCT01320137|E1|Reported Event|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
216293|NCT01320072|B3|Baseline|Total|Total of all reporting groups
216294|NCT01320072|B2|Baseline|Aspirin-tolerant Asthmatics|aspirin-tolerant patients with asthma
216295|NCT01320072|B1|Baseline|Aspirin-sensitive Asthmatics|patients with aspirin exacerbated respiratory disease
216296|NCT01320072|P2|Participant Flow|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
216297|NCT01320072|P1|Participant Flow|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
216298|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Asthma patients with aspirin exacerbated respiratory disease
216299|NCT01320072|O2|Outcome|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
216300|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
216301|NCT01320072|O2|Outcome|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
216302|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
216303|NCT01320072|E2|Reported Event|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
216304|NCT01320072|E1|Reported Event|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
216305|NCT01319877|B3|Baseline|Total|Total of all reporting groups
216306|NCT01319877|B2|Baseline|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216307|NCT01319877|B1|Baseline|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216308|NCT01319877|P2|Participant Flow|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216309|NCT01319877|P1|Participant Flow|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216310|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216311|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216312|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216313|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216314|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216315|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216316|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216317|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216318|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216319|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216320|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216321|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216322|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216323|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216324|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216325|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216326|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216327|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216328|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216329|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216330|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216331|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216332|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216333|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216334|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216335|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216336|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216337|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216338|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216339|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216340|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
216341|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
216342|NCT01319877|E1|Reported Event|First and Second Line Treatment|The participants from the first line and second line treatments were combined for the adverse event analysis.
216343|NCT01319851|B1|Baseline|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
216344|NCT01319851|P1|Participant Flow|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
216345|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
216346|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
216347|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
216348|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
216349|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
216350|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
216351|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
216352|NCT01319851|E1|Reported Event|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
216353|NCT01319812|B3|Baseline|Total|Total of all reporting groups
216354|NCT01319812|B2|Baseline|Pulsar Stent Group|Subjects implanted with an Astron Pulsar or Pulsar-18 stent.
216356|NCT01319812|P2|Participant Flow|Pulsar Stent Group|Subjects implanted with an Astron Pulsar or Pulsar-18 stent.
216357|NCT01319812|P1|Participant Flow|Astron Stent Group|Subjects implanted with an Astron stent.
216358|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
216359|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
216360|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
216361|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
216362|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
216363|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
216364|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
216365|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
216366|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
216367|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
216368|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
216369|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
216370|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
216371|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
216372|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216373|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216374|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216375|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216376|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216377|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216378|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216379|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216380|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216381|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216382|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216383|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216384|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216385|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216386|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216387|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216388|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216389|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216390|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216391|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216392|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216393|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216394|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
216395|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
216396|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216397|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216398|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216399|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216400|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216401|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216402|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216403|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216404|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216405|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216406|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216407|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216408|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216409|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216410|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216411|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216412|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216413|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216414|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216415|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216416|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216417|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216418|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216419|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216420|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216421|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216422|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216423|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
216424|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216425|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216426|NCT01319812|E2|Reported Event|Pulsar Stent Group|Subjects indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
216427|NCT01319812|E1|Reported Event|Astron Stent Group|Subjects indicated for stenting in iliac atherosclerotic lesions.
216428|NCT01319799|B1|Baseline|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
216429|NCT01319799|P1|Participant Flow|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
216430|NCT01319799|O1|Outcome|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
216431|NCT01319799|O1|Outcome|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
216432|NCT01319799|E1|Reported Event|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
216433|NCT01319773|B6|Baseline|Total|Total of all reporting groups
216434|NCT01319773|B5|Baseline|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
216435|NCT01319773|B4|Baseline|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
216436|NCT01319773|B3|Baseline|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
216437|NCT01319773|B2|Baseline|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
216438|NCT01319773|B1|Baseline|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
216439|NCT01319773|P5|Participant Flow|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
216440|NCT01319773|P4|Participant Flow|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
216441|NCT01319773|P3|Participant Flow|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
216442|NCT01319773|P2|Participant Flow|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
216443|NCT01319773|P1|Participant Flow|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
216444|NCT01319773|O3|Outcome|Cyclosporine 0.05%|
216445|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
216446|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
216447|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
216448|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
216449|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
216450|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
216451|NCT01319773|E5|Reported Event|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
216452|NCT01319773|E4|Reported Event|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
216453|NCT01319773|E3|Reported Event|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
216454|NCT01319773|E2|Reported Event|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
216455|NCT01319773|E1|Reported Event|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
216456|NCT01319721|B3|Baseline|Total|Total of all reporting groups
216457|NCT01319721|B2|Baseline|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
216458|NCT01319721|B1|Baseline|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
216459|NCT01319721|P2|Participant Flow|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
216460|NCT01319721|P1|Participant Flow|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
216461|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
216462|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
216463|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
216464|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
216465|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
216466|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
216467|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
216468|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
216469|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
216470|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
216495|NCT01319500|O5|Outcome|Total|All gynecologists (private and public) and dermatologists
216471|NCT01319721|E2|Reported Event|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
216472|NCT01319721|E1|Reported Event|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
216473|NCT01319617|B1|Baseline|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.
All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
216474|NCT01319617|P1|Participant Flow|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.
All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center."
216475|NCT01319617|O1|Outcome|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.
All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
216476|NCT01319617|E1|Reported Event|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.
All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
216477|NCT01319552|B1|Baseline|Transfusion|"Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions Old transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions"
216478|NCT01319552|P1|Participant Flow|Transfusion|Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
216479|NCT01319552|O2|Outcome|Old Transfusion|Old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
216480|NCT01319552|O1|Outcome|Fresh Transfusion|Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
216481|NCT01319552|E1|Reported Event|Transfusion|Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
216482|NCT01319539|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
Akt Inhibitor MK2206: Given PO
Therapeutic Conventional Surgery: Undergo surgery
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies"
216483|NCT01319539|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
Akt Inhibitor MK2206: Given PO
Therapeutic Conventional Surgery: Undergo surgery
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies"
216484|NCT01319539|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
Akt Inhibitor MK2206: Given PO
Therapeutic Conventional Surgery: Undergo surgery
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies"
216485|NCT01319539|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
Akt Inhibitor MK2206: Given PO
Therapeutic Conventional Surgery: Undergo surgery
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies"
216486|NCT01319539|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
Akt Inhibitor MK2206: Given PO
Therapeutic Conventional Surgery: Undergo surgery
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies"
216487|NCT01319539|E3|Reported Event|Treatment (MK2206) Dose Level 90mg|Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
216488|NCT01319539|E2|Reported Event|Treatment (MK2206) Dose Level 135mg|Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
216489|NCT01319539|E1|Reported Event|Treatment (MK2206) Dose Level 200mg|Patients receive Akt inhibitor MK2206 PO on days -9 and -2, and undergo segmental resection or total mastectomy on day 0.
216490|NCT01319500|B3|Baseline|Total|Total of all reporting groups
216491|NCT01319500|B2|Baseline|Other OCs|"Users of OCs except Yasmin (Other OCs)"
216492|NCT01319500|B1|Baseline|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
216493|NCT01319500|P2|Participant Flow|Other OCs|"Users of oral contraceptives (OCs) except Yasmin (Other OCs)"
216494|NCT01319500|P1|Participant Flow|Yasmin|"Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC Yasmin"
216496|NCT01319500|O4|Outcome|Dermatologists|All dermatologists
216501|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
216502|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
216503|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
216504|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
216505|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
216506|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
216507|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
216508|NCT01319500|E2|Reported Event|Other OCs|"Users of OCs except Yasmin (Other OCs)"
216509|NCT01319500|E1|Reported Event|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
216510|NCT01319422|B3|Baseline|Total|Total of all reporting groups
216511|NCT01319422|B2|Baseline|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216512|NCT01319422|B1|Baseline|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216513|NCT01319422|P2|Participant Flow|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216514|NCT01319422|P1|Participant Flow|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216515|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216516|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216517|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216518|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216519|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216520|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216521|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216522|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216523|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216524|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216525|NCT01319422|E2|Reported Event|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216526|NCT01319422|E1|Reported Event|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
216527|NCT01319396|B1|Baseline|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
216528|NCT01319396|P1|Participant Flow|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
216529|NCT01319396|O1|Outcome|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
216530|NCT01319396|E1|Reported Event|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
216531|NCT01319383|B1|Baseline|Single, Multiple and Interval Dosing Of Vorinostat 400 mg PO|The study was separated into Arms for reporting purposes required in this report. The data representing the eligibility and baseline measures were the same throughout the study and are therefore reported as a composite of the entire study. Vorinostat 400 mg PO was administered in single and multiple doses in both Arm 1 and 2. The entire cohort is described below and representative of all who were enrolled in the study over the 5 year period.
216532|NCT01319383|P2|Participant Flow|Interval Dosing|There are 4 steps in this Arm. Step 1 Baseline leukapheresis (Visit 2) to obtain resting CD4+ T cells for quantitation of resting CD4+ T cell infection (RCI) and resting CD4+ T cell- associated HIV RNA (RCVL). Ex-vivo exposure to measure RCVL responsiveness to Vorinostat. Step 2 involved measurement of in vivo response to single dose of VOR. Step 3 involved 2 doses separated by 48 or 72 hours. In vivo responsiveness measured for optimal dose interval and step advancement. Step 4 measured significance of response to VOR 400 mg PO taken every 72 hours for 10 doses.
216533|NCT01319383|P1|Participant Flow|Single and Multiple Dose|There are 3 Steps in this Arm: Step 1 a Baseline leukapheresis was completed to obtain resting CD4+ T cells for quantitation of resting CD4+ T cell infection (RCI) and resting CD4+ T cell- associated HIV RNA (RCVL); ex-vivo exposure. Step 2 measured the in-vivo response to single dose of VOR; Step 3 measured the in vivo response after each of 2 series of exposure to multiple doses of VOR 400 mg PO. In each series, 11 doses of VOR were administered for 3 days (M-T-W) and no doses for the remaining 4 days. A leukapheresis was completed 4 hours after the 11th dose to measure in vivo response.
216534|NCT01319383|O2|Outcome|2/Interval Doses (Multiple) Step 4|"Participants without dose-limiting symptoms and exhibiting an in vivo response to the paired dose of VOR dose were eligible to receive 10 doses of VOR 400 mg PO, given at the pre-determined interval. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms and clinical assessments at after the 3rd, 5th, 8th and 10th doses. Participant were only given the required doses for administration between visits.
Leukapheresis procedure performed 4 hours after the 10th dose to measure RCVL in-vivo response."
216559|NCT01318382|P1|Participant Flow|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from neuromuscular blockade (NMB) monitored by a TOF-Watch SX®.
216579|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.
Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
217232|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
216535|NCT01319383|O1|Outcome|1/Single and Multiple Dose, Step 3|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR doses were eligible to receive multiple doses of VOR 400 mg. The first dose was administered in clinic with observation for symptoms for 1 hour post dose. Symptoms were assessed daily and on the third day 4 hours after the dose. These participants took VOR 400 mg (PO) in the AM for 3 days each week (dose every M-T-W) for 3 weeks. On the 4th week, the participant took 2 doses of VOR 400 mg (M-T) in the AM. A leukapheresis was completed 4 hours after the 2nd dose of VOR to measure RCVL in-vivo response. After a 4 – 8 week rest period, participants without dose-limiting symptoms repeated the 4 week cycle.
216536|NCT01319383|O2|Outcome|2/Interval Dosing, Steps 2, 3 and 4|All eligible participants in the Interval Dosing Arm who received at least one dose of VOR 400 mg PO..
216537|NCT01319383|O1|Outcome|1/Single & Multiple Dose, Steps 2 and 3|All eligible participants in the Single and Multiple Arm who received at least one dose of VOR 400 mg PO.
216538|NCT01319383|O2|Outcome|2/Interval Dosing, Steps 2, 3 and 4|All eligible participants in the Interval Dosing Arm who received at least one dose of VOR 400 mg PO.
216539|NCT01319383|O1|Outcome|1/Single & Multiple Dose, Steps 2 and 3|All eligible participants in the Single and Multiple Group Arm who received at least one dose of VOR 400 mg PO.
216540|NCT01319383|O2|Outcome|2/Interval Dosing, Steps 2, 3 and 4|All eligible participants in the Interval Dosing Arm who received at least one dose of VOR 400 mg PO
216541|NCT01319383|O1|Outcome|1/Single & Multiple Dose, Steps 2 and 3|All eligible participants in the Single and Multiple Group Arm who received at least one dose of VOR 400 mg PO
216542|NCT01319383|O1|Outcome|Interval Doses (Multiple) Step 4|"Participants without dose-limiting symptoms and exhibiting an in vivo response to the paired doses of VOR 400 mg PO were eligible to receive 10 doses of VOR, given at the pre-determined interval. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms and clinical assessments at after the 3rd, 5th, 8th and 10th doses. Participant were only given the required doses for administration between visits.
Leukapheresis procedure performed 4 hours after the 10th dose to measure RCVL in-vivo response."
216543|NCT01319383|O2|Outcome|Interval Dosing, Step 3 (72 Hour Interval)|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR dose were eligible to receive 2 doses of VOR 400 mg PO, given at the pre-determined interval of 72 hours. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms. Leukapheresis procedure performed 4 hours after the 2nd dose to measure RCVL in-vivo response.
216544|NCT01319383|O1|Outcome|Interval Dosing , Step 3 (48 hr Interval)|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR dose were eligible to receive 2 doses of VOR 400 mg PO, given at the pre-determined interval of 48 hours. Participant took the PO doses at home per schedule with daily telephone assessment of symptoms. Leukapheresis procedure performed 4 hours after the 2nd dose to measure RCVL in-vivo response.
216545|NCT01319383|O1|Outcome|Arm 1 - Single and Multiple Dose, Step 3|Participants without dose-limiting symptoms and exhibiting an in vivo response to single VOR doses were eligible to receive multiple doses of VOR 400 mg. The first dose was administered in clinic with observation for symptoms for 1 hour post dose. Symptoms were assessed daily and on the third day 4 hours after the dose. These participants took VOR 400 mg (PO) in the AM for 3 days each week (dose every M-T-W) for 3 weeks. On the 4th week, the participant took 2 doses of VOR 400 mg (M-T) in the AM. A leukapheresis was completed 4 hours after the 2nd dose of VOR to measure RCVL in-vivo response. After a 4 – 8 week rest period, participants without dose-limiting symptoms repeated the 4 week cycle.
216546|NCT01319383|O2|Outcome|2/Interval Dosing, Visit 3|Participants enrolled in Arm 2 receiving a single dose of VOR 400 mg PO after demonstrating an ex vivo response at baseline. Symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
216547|NCT01319383|O1|Outcome|1/Single & Multiple Dose, Step 2, Visit 5|Participants enrolled in Arm 1 were given one dose of VOR 200 mg by mouth (PO), symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
216548|NCT01319383|E1|Reported Event|Open Label - Translational Research Study|"Period One: Step 1 (ex-vivo), Step 2 (single dose) and Step 3 (multiple dose). Advancement to each step required demonstration of significant HIV-1 RNA expression per 1 million RCVL response to VOR. Step 1: All participants had an ex-vivo exposure to VOR. Step 2: Participants with and without an ex-vivo response received 1 single dose VOR. Step 3: Participants demonstrating an in vivo response received multiple doses consisting of 2 series of 11 VOR doses each; with in vivo response measured after each series. Period One was stopped due to lack of significant in-vivo response to the multiple doses.
Period Two: Step 1, Step 2 and advancement criteria are the same as above. Step 3 (interval paired dose) and Step 4 (multiple interval doses). Participants without an ex-vivo response did not progress past Step 1. Step 3: Responders received 2 doses separated by 48 or 72 hours. Step 4: Responders then received 10 doses of VOR at pre-determined interval."
216549|NCT01319318|B1|Baseline|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
216550|NCT01319318|P1|Participant Flow|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
216551|NCT01319318|O1|Outcome|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
216552|NCT01319318|E1|Reported Event|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
216553|NCT01318408|B1|Baseline|Open Label|All participants received study drug.
216554|NCT01318408|P1|Participant Flow|Open Label|All participants received study drug.
216555|NCT01318408|O1|Outcome|Open Label|All participants received study drug.
216556|NCT01318408|O1|Outcome|Open Label|All participants received study drug.
216557|NCT01318408|E1|Reported Event|Open Label|All participants received study drug. Four withdrew due to adverse events; related to fatigue.
216558|NCT01318382|B1|Baseline|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
216578|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.
Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
216630|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216560|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of PACU arrival.
216561|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
216562|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of PACU arrival.
216563|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
216564|NCT01318382|E1|Reported Event|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
216565|NCT01319110|B3|Baseline|Total|Total of all reporting groups
216566|NCT01319110|B2|Baseline|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.
Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
216567|NCT01319110|B1|Baseline|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.
Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
216568|NCT01319110|P2|Participant Flow|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.
Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
216569|NCT01319110|P1|Participant Flow|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.
Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
216570|NCT01319110|O2|Outcome|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.
Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
216571|NCT01319110|O1|Outcome|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.
Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
216572|NCT01319110|O2|Outcome|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.
Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
216573|NCT01319110|O1|Outcome|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.
Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
216574|NCT01319110|E2|Reported Event|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.
Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
216575|NCT01319110|E1|Reported Event|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.
Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
216576|NCT01319045|B1|Baseline|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.
Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
216577|NCT01319045|P1|Participant Flow|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.
Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
216631|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216580|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.
Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
216581|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.
Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
216582|NCT01319045|E1|Reported Event|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.
Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
216583|NCT01318967|B1|Baseline|Furosemide|"With and without furosemide
Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
216584|NCT01318967|P1|Participant Flow|Furosemide|"With and without furosemide
Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
216585|NCT01318967|O1|Outcome|MRI After Furosemide|"After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow
Furosemide: Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only."
216586|NCT01318967|O1|Outcome|Furosemide|"With and without furosemide
Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide.
Renal blood flow is measured by PAH method and by MRI method"
216587|NCT01318967|E1|Reported Event|Furosemide|"With and without furosemide
Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
216588|NCT01318876|B1|Baseline|Health Care Workers|HCW who had completed at least 1 survey (n=6269) and not the number of participants enrolled in the study.
216589|NCT01318876|P1|Participant Flow|Health Care Workers|
216590|NCT01318876|O1|Outcome|HCW From All Sites|
216591|NCT01318876|O1|Outcome|HCW From All Sites|
216592|NCT01318876|E1|Reported Event|HCW From All Sites|
216593|NCT01318733|B1|Baseline|CD07805/47 Gel 0.5%|CD07805/47 Gel 0.5% once daily
216594|NCT01318733|P1|Participant Flow|CD07805/47 Gel 0.5%|CD07805/47 Gel 0.5% once daily
216595|NCT01318733|O1|Outcome|CD07805/47 Gel 0.5% QD|
216596|NCT01318733|E1|Reported Event|CD07805/47 Gel 0.5%|
216597|NCT01318694|B5|Baseline|Total|Total of all reporting groups
216598|NCT01318694|B4|Baseline|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216599|NCT01318694|B3|Baseline|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216600|NCT01318694|B2|Baseline|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216601|NCT01318694|B1|Baseline|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216602|NCT01318694|P4|Participant Flow|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216603|NCT01318694|P3|Participant Flow|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
216604|NCT01318694|P2|Participant Flow|Treatment Arm B|Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
216605|NCT01318694|P1|Participant Flow|Treatment Arm A|Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT)
216606|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216607|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216608|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216609|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216610|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216611|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216612|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216613|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216614|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216615|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216616|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216617|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216618|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216619|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216620|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216621|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216622|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216623|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216624|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216625|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216626|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216627|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216628|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216629|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216632|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216633|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216634|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216635|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216636|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216637|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216638|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216639|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216640|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216641|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216642|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216643|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216644|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216645|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216646|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216647|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216648|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216649|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216650|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216651|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216652|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
216653|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216654|NCT01318694|E4|Reported Event|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
216655|NCT01318694|E3|Reported Event|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
216656|NCT01318694|E2|Reported Event|Treatment Arm B|Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
216657|NCT01318694|E1|Reported Event|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
216658|NCT01318538|B3|Baseline|Total|Total of all reporting groups
216659|NCT01318538|B2|Baseline|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community. NOTE: Baseline characteristics reported in Table Below reflect all participants including men assigned to the GDC condition. Analysis of data for study specific aims include only women randomized to WRG (N=52) and GDC (N=48).
216660|NCT01318538|B1|Baseline|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216661|NCT01318538|P3|Participant Flow|Group Therapist|Therapists who ran and led the group sessions for both the single-gender Women's Recovery Group and mixed-gender Group Drug Counseling.
216662|NCT01318538|P2|Participant Flow|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
216663|NCT01318538|P1|Participant Flow|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216664|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
216665|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216666|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
216667|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216668|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
216669|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216670|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
216671|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216672|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
216704|NCT01318499|B2|Baseline|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216839|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216673|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216674|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Participants in this analysis are the therapists that lead GDC groups. Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
216675|NCT01318538|O1|Outcome|Women's Recovery Group|Participants in this analysis are the therapists that lead the WRG groups. The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216676|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
216677|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216678|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
216679|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216680|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
216681|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216808|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216682|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
216683|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
216684|NCT01318538|E2|Reported Event|Mixed-gender Group Drug Counseling|The GDC is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance dependence; 3) increase patients’ self-awareness of the problems that substance dependence has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse.
216685|NCT01318538|E1|Reported Event|Women's Recovery Group|The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (b) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (c) help participants with skills and strategies useful in preventing relapse and promote recovery.
216686|NCT01318512|B1|Baseline|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
216687|NCT01318512|P1|Participant Flow|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
216688|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216689|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216690|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216691|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216692|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216693|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216694|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216695|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216696|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216697|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
216698|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216699|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of haemoglobin.
216700|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216701|NCT01318512|E1|Reported Event|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
216702|NCT01318499|B4|Baseline|Total|Total of all reporting groups
216703|NCT01318499|B3|Baseline|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216705|NCT01318499|B1|Baseline|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216706|NCT01318499|P3|Participant Flow|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216707|NCT01318499|P2|Participant Flow|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216708|NCT01318499|P1|Participant Flow|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216709|NCT01318499|O3|Outcome|Nepafenac 0.3% Vehicle|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216710|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216711|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216712|NCT01318499|O3|Outcome|Nepafenac 0.3% Vehicle|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216713|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216714|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216715|NCT01318499|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216716|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216717|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216718|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216719|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216720|NCT01318499|O2|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216721|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216722|NCT01318499|E3|Reported Event|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216723|NCT01318499|E2|Reported Event|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216724|NCT01318499|E1|Reported Event|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
216725|NCT01318278|B4|Baseline|Total|Total of all reporting groups
216726|NCT01318278|B3|Baseline|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216727|NCT01318278|B2|Baseline|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216728|NCT01318278|B1|Baseline|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216729|NCT01318278|P3|Participant Flow|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216730|NCT01318278|P2|Participant Flow|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216731|NCT01318278|P1|Participant Flow|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216732|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216733|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216734|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216735|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216736|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216737|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216738|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216739|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216740|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216741|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216742|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216743|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216744|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216745|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216746|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216747|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216748|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216749|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216750|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216751|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216752|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216753|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216754|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216755|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216756|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
217233|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
216757|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216758|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216759|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216760|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216761|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216762|NCT01318278|O3|Outcome|Comparison Group|Infants not diagnosed with hypotension in first 24 hours
216763|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216764|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216765|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216766|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216767|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216768|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216769|NCT01318278|E3|Reported Event|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
216770|NCT01318278|E2|Reported Event|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr
Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
216771|NCT01318278|E1|Reported Event|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min
Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
216772|NCT01318135|B5|Baseline|Total|Total of all reporting groups
216773|NCT01318135|B4|Baseline|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216774|NCT01318135|B3|Baseline|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216775|NCT01318135|B2|Baseline|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216776|NCT01318135|B1|Baseline|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216777|NCT01318135|P8|Participant Flow|Metformin Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
216778|NCT01318135|P7|Participant Flow|Metformin Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
216779|NCT01318135|P6|Participant Flow|CCT/006 - 25 mg Dose Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
216780|NCT01318135|P5|Participant Flow|CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
216809|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216781|NCT01318135|P4|Participant Flow|Glimepiride Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
216782|NCT01318135|P3|Participant Flow|Glimepiride Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
216783|NCT01318135|P2|Participant Flow|CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
216784|NCT01318135|P1|Participant Flow|CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
216785|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216786|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216787|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216788|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216789|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216790|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216791|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216792|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216793|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216794|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216795|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216796|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216797|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216798|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216799|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216800|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216801|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216802|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216803|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216804|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216805|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216806|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216807|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216810|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216811|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216812|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216813|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216814|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216815|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216816|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216817|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216818|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216819|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216820|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216821|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216822|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216823|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216824|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216825|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216826|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216827|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216828|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216829|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216830|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216831|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216832|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216833|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216834|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216835|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216836|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216837|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216838|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216840|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216841|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216842|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216843|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216844|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216845|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216846|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216847|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216848|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216849|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216850|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216851|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216852|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216853|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216854|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216855|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216856|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216857|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216858|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216859|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216860|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216861|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216862|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216863|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216864|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216865|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216866|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216867|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216868|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216869|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216870|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216871|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216872|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216873|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216874|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216875|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216876|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216877|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216878|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216879|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216880|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216881|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216882|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216883|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216884|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216885|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216886|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216887|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216888|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216889|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216890|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216891|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216892|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216893|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216894|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216895|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216896|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216897|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216898|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216899|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216900|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216901|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216902|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216903|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216904|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216905|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216906|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216907|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216908|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216909|NCT01318135|E4|Reported Event|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216910|NCT01318135|E3|Reported Event|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
216911|NCT01318135|E2|Reported Event|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216912|NCT01318135|E1|Reported Event|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
216913|NCT01318122|B3|Baseline|Total|Total of all reporting groups
216914|NCT01318122|B2|Baseline|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216915|NCT01318122|B1|Baseline|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216916|NCT01318122|P4|Participant Flow|Pioglitazone Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
216917|NCT01318122|P3|Participant Flow|Pioglitazone Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
216918|NCT01318122|P2|Participant Flow|CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
216919|NCT01318122|P1|Participant Flow|CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
216920|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216921|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216922|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216923|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216924|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216925|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216926|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216927|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216928|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216929|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216930|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216931|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216932|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216933|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216934|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216935|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216936|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216937|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216938|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216939|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216940|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216941|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216942|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216943|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216944|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216945|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216946|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216947|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216948|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216949|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216950|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216951|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216952|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216953|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216954|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216955|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216956|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216957|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216958|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216959|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216960|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216961|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216962|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216963|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216964|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216965|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216966|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216967|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216968|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216969|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216970|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216971|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216972|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216973|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216974|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216975|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216976|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216977|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216978|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216979|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216980|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216981|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216982|NCT01318122|E2|Reported Event|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
216983|NCT01318122|E1|Reported Event|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
216984|NCT01318109|B4|Baseline|Total|Total of all reporting groups
216985|NCT01318109|B3|Baseline|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
216986|NCT01318109|B2|Baseline|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
216987|NCT01318109|B1|Baseline|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
216988|NCT01318109|P3|Participant Flow|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
216989|NCT01318109|P2|Participant Flow|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
216990|NCT01318109|P1|Participant Flow|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
216991|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
216992|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
216993|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217144|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
216994|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
216995|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
216996|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
216997|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
216998|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
216999|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217000|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217001|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217002|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217003|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217004|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217005|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217006|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217007|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217008|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217009|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217010|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217011|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217012|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217013|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217014|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217015|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217016|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217017|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217018|NCT01318109|E3|Reported Event|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217019|NCT01318109|E2|Reported Event|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217020|NCT01318109|E1|Reported Event|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
217021|NCT01318083|B4|Baseline|Total|Total of all reporting groups
217022|NCT01318083|B3|Baseline|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217023|NCT01318083|B2|Baseline|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217024|NCT01318083|B1|Baseline|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217025|NCT01318083|P3|Participant Flow|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217026|NCT01318083|P2|Participant Flow|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217145|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217027|NCT01318083|P1|Participant Flow|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217028|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217029|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217030|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217031|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217032|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217033|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217034|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217035|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217036|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217037|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217038|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217039|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217040|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217041|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217042|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217043|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217044|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217045|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217046|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217047|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217048|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217049|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217050|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217051|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217052|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217053|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217054|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217055|NCT01318083|E3|Reported Event|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
217056|NCT01318083|E2|Reported Event|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217057|NCT01318083|E1|Reported Event|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
217058|NCT01318070|B4|Baseline|Total|Total of all reporting groups
217059|NCT01318070|B3|Baseline|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217060|NCT01318070|B2|Baseline|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217061|NCT01318070|B1|Baseline|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217062|NCT01318070|P3|Participant Flow|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217063|NCT01318070|P2|Participant Flow|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217064|NCT01318070|P1|Participant Flow|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217065|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217066|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217067|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217068|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217069|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217070|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217071|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217072|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217073|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217074|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217075|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217076|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217077|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217078|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217079|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217080|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217081|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217082|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217083|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217084|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217085|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217086|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217087|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217088|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217089|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217090|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217091|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217092|NCT01318070|E3|Reported Event|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217093|NCT01318070|E2|Reported Event|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217094|NCT01318070|E1|Reported Event|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
217095|NCT01317901|B3|Baseline|Total|Total of all reporting groups
217096|NCT01317901|B2|Baseline|TRU-016 (20 mg/kg) +Bendamustine+Rituximab|
217097|NCT01317901|B1|Baseline|TRU-016 (10 mg/kg) +Bendamustine+Rituximab|
217098|NCT01317901|P2|Participant Flow|20 mg/kg TRU-016+Bendamustine+Rituximab|"TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m^2 rituximab was administered by IV infusion on Day 2 of each cycle.
Bendamustine: 90 mg/m^2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle."
217146|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217147|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217234|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217099|NCT01317901|P1|Participant Flow|10 mg/kg TRU-016+Bendamustine+Rituximab|"TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m^2 rituximab was administered by IV infusion on Day 2 of each cycle.
Bendamustine: 90 mg/m^2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle."
217100|NCT01317901|O2|Outcome|20 mg/kg of TRU 016 + Bendamustine + Rituximab|20 mg/kg of TRU 016 combined with rituximab 375 mg/m^2 and bendamustine 90 mg/m^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.
217101|NCT01317901|O1|Outcome|TRU-016 (10 mg/kg) + Bendamustine + Rituximab|"10 mg/kg of TRU 016 combined with rituximab 375 mg/m^2 and bendamustine 90 mg/m^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.
TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle
Bendamustine: Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle.
Rituximab: Rituximab by IV administration at 375 mg/m^2 on Day 2 of each 28 day cycle."
217102|NCT01317901|E2|Reported Event|TRU-016 (20 mg/kg)|TRU-016 (20 mg/kg) + bendamustine + rituximab
217103|NCT01317901|E1|Reported Event|TRU-016 (10 mg/kg)|TRU-016 (10 mg/kg) + bendamustine + rituximab
217104|NCT01317797|B4|Baseline|Total|Total of all reporting groups
217105|NCT01317797|B3|Baseline|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217106|NCT01317797|B2|Baseline|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217107|NCT01317797|B1|Baseline|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217108|NCT01317797|P3|Participant Flow|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217109|NCT01317797|P2|Participant Flow|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217110|NCT01317797|P1|Participant Flow|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217111|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217112|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217113|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217114|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217115|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217116|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217117|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217118|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217119|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217120|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217121|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217122|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217123|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217124|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217125|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217126|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217127|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217128|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217129|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217130|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217131|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217132|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217133|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217134|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217135|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217136|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217137|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217138|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217139|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217140|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217141|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217142|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217143|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217215|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
217148|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217149|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217150|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217151|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217152|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217153|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217154|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217155|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217156|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217157|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217158|NCT01317797|E3|Reported Event|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
217159|NCT01317797|E2|Reported Event|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
217160|NCT01317797|E1|Reported Event|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
217161|NCT01317667|B4|Baseline|Total|Total of all reporting groups
217162|NCT01317667|B3|Baseline|Group 3|RVEc vaccine 100 μg/dose x 1 dose
217163|NCT01317667|B2|Baseline|Group 2|RVEc vaccine 50 μg/dose x 3 doses
217164|NCT01317667|B1|Baseline|Group 1|RVEc vaccine 20 μg/dose x 3 doses
217165|NCT01317667|P3|Participant Flow|Group 3|RVEc vaccine 100 μg/dose x 1 dose
217166|NCT01317667|P2|Participant Flow|Group 2|RVEc vaccine 50 μg/dose x 3 doses
217167|NCT01317667|P1|Participant Flow|Group 1|RVEc vaccine 20 μg/dose x 3 doses
217168|NCT01317667|O3|Outcome|Group 3|RVEc vaccine 100 μg/dose x 1 dose
217169|NCT01317667|O2|Outcome|Group 2|RVEc vaccine 50 μg/dose x 3 doses
217170|NCT01317667|O1|Outcome|Group 1|RVEc vaccine 20 μg/dose x 3 doses
217171|NCT01317667|O3|Outcome|Group 3|RVEc vaccine 100 μg/dose x 1 dose
217172|NCT01317667|O2|Outcome|Group 2|RVEc vaccine 50 μg/dose x 3 doses
217173|NCT01317667|O1|Outcome|Group 1|RVEc vaccine 20 μg/dose x 3 doses
217174|NCT01317667|E3|Reported Event|Group 3|RVEc vaccine 100 μg/dose x 1 dose
217175|NCT01317667|E2|Reported Event|Group 2|RVEc vaccine 50 μg/dose x 3 doses
217176|NCT01317667|E1|Reported Event|Group 1|RVEc vaccine 20 μg/dose x 3 doses
217177|NCT01317641|B10|Baseline|Total|Total of all reporting groups
217178|NCT01317641|B9|Baseline|Phase 2 (1400mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
217179|NCT01317641|B8|Baseline|Phase 2 (400mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
217180|NCT01317641|B7|Baseline|Phase 2 (200mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously
217181|NCT01317641|B6|Baseline|Phase 1, 1800mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
217182|NCT01317641|B5|Baseline|Phase 1, 1400mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
217183|NCT01317641|B4|Baseline|Phase 1, 1000mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
217184|NCT01317641|B3|Baseline|Phase 1, 600mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
217185|NCT01317641|B2|Baseline|Phase 1, 400mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
217186|NCT01317641|B1|Baseline|Phase 1, 200mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
217187|NCT01317641|P9|Participant Flow|Phase 2: ODM-201 1400mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
217188|NCT01317641|P8|Participant Flow|Phase 2: ODM-201 400mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
217189|NCT01317641|P7|Participant Flow|Phase 2: ODM-201 200mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
217190|NCT01317641|P6|Participant Flow|Phase 1: ODM-201 1800 mg/Day|Dose escalation
217191|NCT01317641|P5|Participant Flow|Phase 1: ODM-201 1400 mg/Day|Dose escalation
217192|NCT01317641|P4|Participant Flow|Phase 1: ODM-201 1000 mg/Day|Dose escalation
217193|NCT01317641|P3|Participant Flow|Phase 1: ODM-201 600 mg/Day|Dose escalation
217194|NCT01317641|P2|Participant Flow|Phase 1: ODM-201 400 mg/Day|Dose escalation
217195|NCT01317641|P1|Participant Flow|Phase 1: ODM-201 200 mg/Day|Dose escalation
217196|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
217197|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
217198|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
217199|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
217200|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
217201|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
217202|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
217203|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
217204|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
217205|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
217206|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
217207|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
217208|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
217209|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
217210|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
217211|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
217212|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
217213|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
217214|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
217235|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217236|NCT01317641|O5|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217237|NCT01317641|O4|Outcome|1000mg/Day ODM-201|Phase 1
217238|NCT01317641|O3|Outcome|600mg/Day ODM-201|Phase 1
217239|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217240|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217241|NCT01317641|O5|Outcome|1800mg/Day ODM-201|Phase 1
217242|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217243|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
217244|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217245|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217246|NCT01317641|O3|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217247|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217248|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217249|NCT01317641|O5|Outcome|1800mg/Day ODM-201|Phase 1
217250|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217251|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
217252|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217253|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217254|NCT01317641|O5|Outcome|1800mg/Day ODM-201|Phase 1
217255|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217256|NCT01317641|O3|Outcome|600mg/Day ODM-201|Phase 1
217257|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217258|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217259|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217260|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
217261|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217262|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217263|NCT01317641|O6|Outcome|1800mg/Day ODM-201|Phase 1
217264|NCT01317641|O5|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217265|NCT01317641|O4|Outcome|1000mg/Day ODM-201|Phase 1
217266|NCT01317641|O3|Outcome|600mg/Day ODM-201|Phase 1
217267|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217268|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217269|NCT01317641|O6|Outcome|1800mg/Day ODM-201|phase 1
217270|NCT01317641|O5|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217271|NCT01317641|O4|Outcome|1000mg/Day ODM-201|phase 1
217272|NCT01317641|O3|Outcome|600mg/Day ODM-201|phase 1
217273|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217274|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
217275|NCT01317641|O6|Outcome|Phase 1: ODM-201 1800 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217276|NCT01317641|O5|Outcome|Phase 1: ODM-201 1400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217277|NCT01317641|O4|Outcome|Phase 1: ODM-201 1000 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217278|NCT01317641|O3|Outcome|Phase 1: ODM-201 600 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217279|NCT01317641|O2|Outcome|Phase 1: ODM-201 400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217280|NCT01317641|O1|Outcome|Phase 1: ODM-201 200 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217281|NCT01317641|O6|Outcome|Phase 1: ODM-201 1800 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217282|NCT01317641|O5|Outcome|Phase 1: ODM-201 1400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217283|NCT01317641|O4|Outcome|Phase 1: ODM-201 1000 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217284|NCT01317641|O3|Outcome|Phase 1: ODM-201 600 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217285|NCT01317641|O2|Outcome|Phase 1: ODM-201 400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217286|NCT01317641|O1|Outcome|Phase 1: ODM-201 200 mg/Day|Participants received twice daily of oral ODM-201 continuously.
217287|NCT01317641|E9|Reported Event|Phase 2, 1400mg/Day ODM-201|Dose expansion
217288|NCT01317641|E8|Reported Event|Phase 2, 400mg/Day ODM-201|Dose expansion
217289|NCT01317641|E7|Reported Event|Phase 2, 200mg/Day ODM-201|Dose expansion
217290|NCT01317641|E6|Reported Event|Phase 1, 1800mg/Day ODM-201|Dose escalation
217291|NCT01317641|E5|Reported Event|Phase 1, 1400mg/Day ODM-201|Dose escalation
217292|NCT01317641|E4|Reported Event|Phase 1, 1000mg/Day ODM-201|Dose escalation
217293|NCT01317641|E3|Reported Event|Phase 1, 600mg/Day ODM-201|Dose escalation
217294|NCT01317641|E2|Reported Event|Phase 1, 400mg/Day ODM-201|Dose escalation
217295|NCT01317641|E1|Reported Event|Phase 1, 200mg/Day ODM-201|Dose escalation
217296|NCT01317615|B1|Baseline|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
217297|NCT01317615|P1|Participant Flow|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
217298|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
217299|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
217300|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
217301|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
217302|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
217303|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
217304|NCT01317615|E1|Reported Event|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
217305|NCT01317160|B3|Baseline|Total|Total of all reporting groups
217306|NCT01317160|B2|Baseline|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.
Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
217307|NCT01317160|B1|Baseline|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
217308|NCT01317160|P2|Participant Flow|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.
Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
217309|NCT01317160|P1|Participant Flow|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
217310|NCT01317160|O2|Outcome|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.
Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
217311|NCT01317160|O1|Outcome|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
217312|NCT01317160|O2|Outcome|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.
Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
217313|NCT01317160|O1|Outcome|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
217314|NCT01317160|E2|Reported Event|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.
Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
217315|NCT01317160|E1|Reported Event|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
217316|NCT01317004|B3|Baseline|Total|Total of all reporting groups
217317|NCT01317004|B2|Baseline|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
217318|NCT01317004|B1|Baseline|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
217319|NCT01317004|P2|Participant Flow|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
217320|NCT01317004|P1|Participant Flow|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
217321|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
217322|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
217323|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
217324|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
217325|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
217540|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217326|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
217327|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
217328|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
217329|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
217330|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
217331|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
217332|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
217333|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
217334|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
217335|NCT01317004|E2|Reported Event|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
217336|NCT01317004|E1|Reported Event|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
217337|NCT01316926|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in period 1 and test product in period 2
217338|NCT01316926|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in Period 1; followed by test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2
217339|NCT01316926|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
217340|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
217341|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
217342|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
217343|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
217344|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in both periods
217345|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
217346|NCT01316926|E2|Reported Event|Period 2|Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
217347|NCT01316926|E1|Reported Event|Period 1|Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1
217348|NCT01316913|B5|Baseline|Total|Total of all reporting groups
217349|NCT01316913|B4|Baseline|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
217350|NCT01316913|B3|Baseline|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217351|NCT01316913|B2|Baseline|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217352|NCT01316913|B1|Baseline|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217353|NCT01316913|P4|Participant Flow|TIO18 µg QD|Participants received tiotropium bromide (TIO) 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
217354|NCT01316913|P3|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217355|NCT01316913|P2|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217356|NCT01316913|P1|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI) and placebo QD via a HandiHaler in the morning for 24 weeks.
217357|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
217358|NCT01316913|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217359|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217360|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217361|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
217362|NCT01316913|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217363|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217364|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217365|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
217366|NCT01316913|O3|Outcome|UMEC/VI 125/25 QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217367|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217368|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217369|NCT01316913|E4|Reported Event|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
217370|NCT01316913|E3|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217371|NCT01316913|E2|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217372|NCT01316913|E1|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
217373|NCT01316900|B5|Baseline|Total|Total of all reporting groups
217374|NCT01316900|B4|Baseline|Tiotropium 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
217375|NCT01316900|B3|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217376|NCT01316900|B2|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217377|NCT01316900|B1|Baseline|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
217378|NCT01316900|P4|Participant Flow|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
217379|NCT01316900|P3|Participant Flow|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217380|NCT01316900|P2|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217381|NCT01316900|P1|Participant Flow|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
217382|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
217383|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217384|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217385|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
217386|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
217387|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217388|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217389|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
217390|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
217391|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217392|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217393|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
217394|NCT01316900|E4|Reported Event|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
217395|NCT01316900|E3|Reported Event|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217396|NCT01316900|E2|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
217397|NCT01316900|E1|Reported Event|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
217398|NCT01316887|B4|Baseline|Total|Total of all reporting groups
217399|NCT01316887|B3|Baseline|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217400|NCT01316887|B2|Baseline|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217538|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217401|NCT01316887|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217402|NCT01316887|P3|Participant Flow|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217403|NCT01316887|P2|Participant Flow|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217404|NCT01316887|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217405|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217406|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217407|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217408|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217409|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217410|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217411|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217412|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217413|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217414|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217415|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217416|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217417|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217418|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217419|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217420|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217421|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217422|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217423|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217424|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217425|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217426|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217427|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217428|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217429|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217430|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217431|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217432|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217433|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217434|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217435|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217436|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217437|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217438|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217439|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217440|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217441|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217442|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217443|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217444|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217445|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217446|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217447|NCT01316887|O3|Outcome|UMEC/VI 125/25µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217448|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217449|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217450|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217451|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217452|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217453|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217454|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217455|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217456|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217457|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217458|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217459|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217460|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217461|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
217462|NCT01316887|E3|Reported Event|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
217463|NCT01316887|E2|Reported Event|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
217464|NCT01316887|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.ve
217465|NCT01316692|B1|Baseline|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker identification and analysis: Correlative studies
biopsy: Correlative studies
immunohistochemistry/tissue microarrays: Correlative studies
TdT-mediated dUTP nick end labeling assay: Correlative studies
mass spectrometry: Correlative studies"
217466|NCT01316692|P1|Participant Flow|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker identification and analysis: Correlative studies
biopsy: Correlative studies
immunohistochemistry/tissue microarrays: Correlative studies
TdT-mediated dUTP nick end labeling assay: Correlative studies
mass spectrometry: Correlative studies"
217467|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker identification and analysis: Correlative studies
biopsy: Correlative studies
immunohistochemistry/tissue microarrays: Correlative studies
TdT-mediated dUTP nick end labeling assay: Correlative studies
mass spectrometry: Correlative studies"
217468|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker identification and analysis: Correlative studies
biopsy: Correlative studies
immunohistochemistry/tissue microarrays: Correlative studies
TdT-mediated dUTP nick end labeling assay: Correlative studies
mass spectrometry: Correlative studies"
217469|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker identification and analysis: Correlative studies
biopsy: Correlative studies
immunohistochemistry/tissue microarrays: Correlative studies
TdT-mediated dUTP nick end labeling assay: Correlative studies
mass spectrometry: Correlative studies"
217470|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker identification and analysis: Correlative studies
biopsy: Correlative studies
immunohistochemistry/tissue microarrays: Correlative studies
TdT-mediated dUTP nick end labeling assay: Correlative studies
mass spectrometry: Correlative studies"
217471|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker identification and analysis: Correlative studies
biopsy: Correlative studies
immunohistochemistry/tissue microarrays: Correlative studies
TdT-mediated dUTP nick end labeling assay: Correlative studies
mass spectrometry: Correlative studies"
217472|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker identification and analysis: Correlative studies
biopsy: Correlative studies
immunohistochemistry/tissue microarrays: Correlative studies
TdT-mediated dUTP nick end labeling assay: Correlative studies
mass spectrometry: Correlative studies"
217539|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
217473|NCT01316692|E1|Reported Event|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
laboratory biomarker identification and analysis: Correlative studies
biopsy: Correlative studies
immunohistochemistry/tissue microarrays: Correlative studies
TdT-mediated dUTP nick end labeling assay: Correlative studies
mass spectrometry: Correlative studies"
217474|NCT01316614|B1|Baseline|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
217475|NCT01316614|P1|Participant Flow|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet. Only the order of the passes were randomized.
217476|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
217477|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
217478|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
217479|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
217480|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
217481|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
217482|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
217483|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
217484|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
217485|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
217486|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
217487|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
217488|NCT01316614|E1|Reported Event|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
217489|NCT01316575|B3|Baseline|Total|Total of all reporting groups
217490|NCT01316575|B2|Baseline|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
217491|NCT01316575|B1|Baseline|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
217492|NCT01316575|P2|Participant Flow|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
217493|NCT01316575|P1|Participant Flow|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
217494|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
217495|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
217496|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
217497|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
217498|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
217499|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
217500|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
217501|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
217502|NCT01316575|E2|Reported Event|Low Flow Oxygen|
217503|NCT01316575|E1|Reported Event|nCPAP|
217504|NCT01316419|B1|Baseline|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217505|NCT01316419|P1|Participant Flow|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217506|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217507|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217508|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217509|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217510|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217511|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217512|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217513|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217514|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217515|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217516|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217517|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217518|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217519|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217520|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217521|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217522|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217523|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217524|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217525|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217526|NCT01316419|E1|Reported Event|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
217527|NCT01316380|B4|Baseline|Total|Total of all reporting groups
217528|NCT01316380|B3|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217529|NCT01316380|B2|Baseline|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217530|NCT01316380|B1|Baseline|Placebo|Patients treated with matching placebo
217531|NCT01316380|P3|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217532|NCT01316380|P2|Participant Flow|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217533|NCT01316380|P1|Participant Flow|Placebo|Patients treated with matching placebo
217534|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217535|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217536|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
217537|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217541|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217542|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
217543|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217544|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217545|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
217546|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217547|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217548|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
217549|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217550|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217551|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
217552|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217553|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217554|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
217555|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217556|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217557|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
217558|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217559|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217560|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
217561|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217562|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217563|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
217564|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
217565|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
217566|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
217567|NCT01316380|E3|Reported Event|Tio R5|Enter description here, if needed
217568|NCT01316380|E2|Reported Event|Tio R2.5|Enter description here, if needed
217569|NCT01316380|E1|Reported Event|Placebo|Enter description here, if needed
217570|NCT01316341|B4|Baseline|Total|Total of all reporting groups
217571|NCT01316341|B3|Baseline|Empa 25 mg|25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
217572|NCT01316341|B2|Baseline|Empa 10 mg|10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
217573|NCT01316341|B1|Baseline|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
217574|NCT01316341|P3|Participant Flow|Empa 25 mg|25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
217575|NCT01316341|P2|Participant Flow|Empa 10 mg|10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
217576|NCT01316341|P1|Participant Flow|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
217577|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217578|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217579|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days.
217580|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217581|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217582|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days.
217583|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
217584|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
217585|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
217586|NCT01316341|O2|Outcome|Empa 25 mg|A single dose of 25 mg empagliflozin (empa) taken orally, plus one placebo tablet.
217587|NCT01316341|O1|Outcome|Empa 10 mg|A single dose of 10 mg Empagliflozin (empa) taken orally, plus one placebo tablet.
217588|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217589|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217590|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217591|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217592|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217593|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217594|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217595|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217596|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217597|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217598|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217599|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217600|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217601|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217602|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217603|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217604|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217605|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217606|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217607|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217608|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217609|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217610|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217611|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217612|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
217613|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
217614|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217615|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217616|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217617|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217618|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217619|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217620|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217621|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217622|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217623|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217624|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217625|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217626|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217627|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217628|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217629|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217630|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217631|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217632|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217633|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217634|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217635|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217636|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
217637|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
217638|NCT01316341|E3|Reported Event|Empa 25 mg|25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
217639|NCT01316341|E2|Reported Event|Empa 10 mg|10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
217640|NCT01316341|E1|Reported Event|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
217641|NCT01316315|B3|Baseline|Total|Total of all reporting groups
217642|NCT01316315|B2|Baseline|Placebo|Non-Active
217643|NCT01316315|B1|Baseline|Active|N6022 - 5 mg
217644|NCT01316315|P2|Participant Flow|Placebo|Non-Active
217645|NCT01316315|P1|Participant Flow|Active|N6022 - Active 5 mg
217646|NCT01316315|O2|Outcome|Placebo|Non-Active
217647|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
217648|NCT01316315|O2|Outcome|Placebo|Non-Active
217649|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
217650|NCT01316315|O2|Outcome|Placebo|Non-Active
217651|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
217652|NCT01316315|O2|Outcome|Placebo|Patients received a single IV administration of 5 mL of placebo on Day 1 in each treatment period and single dose of N6022 on the day 1 of the second period.
217653|NCT01316315|O1|Outcome|N6022|Patients received a single IV administration of 5 mL of N6022 on Day 1 in each treatment period and single dose of placebo on Day 1 of the second period.
217654|NCT01316315|E2|Reported Event|Placebo|Non-Active
217655|NCT01316315|E1|Reported Event|Active|N6022 - Active 5 mg
217656|NCT01316302|B3|Baseline|Total|Total of all reporting groups
217657|NCT01316302|B2|Baseline|Placebo|"Matching placebo
Placebo: Matching placebo, taken QD for 12 weeks."
217658|NCT01316302|B1|Baseline|Pristiq|"Flexible dose, 50-100mg QD
Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
217659|NCT01316302|P2|Participant Flow|Placebo|"Matching placebo
Placebo: Matching placebo, taken QD for 12 weeks."
217660|NCT01316302|P1|Participant Flow|Pristiq|"Flexible dose, 50-100mg QD
Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
217661|NCT01316302|O2|Outcome|Placebo|Matching placebo
217662|NCT01316302|O1|Outcome|Pristiq|Flexible dose, 50-100mg QD
217663|NCT01316302|O2|Outcome|Placebo|Matching placebo
217664|NCT01316302|O1|Outcome|Pristiq|Flexible dose, 50-100mg QD
217665|NCT01316302|O2|Outcome|Placebo|"Matching placebo
Placebo: Matching placebo, taken QD for 12 weeks."
217666|NCT01316302|O1|Outcome|Pristiq|"Flexible dose, 50-100mg QD
Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
217667|NCT01316302|E2|Reported Event|Placebo|"Matching placebo
Placebo: Matching placebo, taken QD for 12 weeks."
217668|NCT01316302|E1|Reported Event|Pristiq|"Flexible dose, 50-100mg QD
Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
217669|NCT01316263|B3|Baseline|Total|Total of all reporting groups
217670|NCT01316263|B2|Baseline|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217671|NCT01316263|B1|Baseline|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217672|NCT01316263|P2|Participant Flow|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217673|NCT01316263|P1|Participant Flow|PDGFRα Mutation Positive|20 milligrams per kilogram (mg/kg) of Olaratumab (IMC-3G3) was administered intravenously (IV) on Day 1 of each cycle (14-day cycles) to participants with gastrointestinal stromal tumors (GIST) with genotypes that had a platelet-derived growth factor receptor alpha (PDGFRα) mutation.
217674|NCT01316263|O1|Outcome|PDGFRα Mutation Positive and Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation and that did not have a PDGFRα mutation.
217710|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217675|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217676|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217677|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217678|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217679|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217680|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217681|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217682|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217683|NCT01316263|O1|Outcome|Olaratumab (IMC-3G3)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation or PDGFRα wild type.
217684|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217685|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217686|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217687|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217688|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217689|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217690|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217691|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217692|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217693|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217694|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217695|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217696|NCT01316263|E2|Reported Event|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
217697|NCT01316263|E1|Reported Event|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
217698|NCT01316224|B1|Baseline|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217699|NCT01316224|P1|Participant Flow|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217700|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217701|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217702|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217703|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217704|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217705|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217706|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217707|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217708|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217709|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
217711|NCT01316224|E1|Reported Event|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with Adalimumab
217712|NCT01316055|B4|Baseline|Total|Total of all reporting groups
217713|NCT01316055|B3|Baseline|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217714|NCT01316055|B2|Baseline|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217715|NCT01316055|B1|Baseline|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217716|NCT01316055|P3|Participant Flow|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217717|NCT01316055|P2|Participant Flow|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217718|NCT01316055|P1|Participant Flow|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217719|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg steady-state dosing in volunteers with moderate renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217720|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg and steady-state dosing in volunteers with mild renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217721|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg steady-state dosing in healthy volunteers
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217722|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217723|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217724|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217725|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217726|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217727|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217728|NCT01316055|E3|Reported Event|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217729|NCT01316055|E2|Reported Event|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217730|NCT01316055|E1|Reported Event|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers
Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
217731|NCT01316042|B3|Baseline|Total|Total of all reporting groups
217732|NCT01316042|B2|Baseline|Metformin|2 212.5mg pill/day for 12 months
217733|NCT01316042|B1|Baseline|Sugar Pill|2 pills per day for 12 months
217734|NCT01316042|P2|Participant Flow|Metformin|2 212.5mg pill/day for 12 months
217735|NCT01316042|P1|Participant Flow|Sugar Pill|2 pills per day for 12 months
217736|NCT01316042|O2|Outcome|Metformin|2 212.5mg pill/day for 12 months
217737|NCT01316042|O1|Outcome|Sugar Pill|2 pills per day for 12 months
217738|NCT01316042|E2|Reported Event|Metformin|2 212.5mg pill/day for 12 months
217739|NCT01316042|E1|Reported Event|Sugar Pill|2 pills per day for 12 months
217740|NCT01315847|B3|Baseline|Total|Total of all reporting groups
217741|NCT01315847|B2|Baseline|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217742|NCT01315847|B1|Baseline|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217743|NCT01315847|P2|Participant Flow|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217744|NCT01315847|P1|Participant Flow|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline positron emission tomography (PET) imaging of the brain using [11C]MK-4232 tracer (~300 megabecquerel [MBq]) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217745|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217746|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217747|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217748|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217749|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217750|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217751|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217776|NCT01315574|P1|Participant Flow|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.
Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
218547|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
217752|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217753|NCT01315847|E2|Reported Event|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217754|NCT01315847|E1|Reported Event|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
217755|NCT01315665|B3|Baseline|Total|Total of all reporting groups
217756|NCT01315665|B2|Baseline|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis
Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217757|NCT01315665|B1|Baseline|Healthy Volunteers|"Healthy volunteers
Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217758|NCT01315665|P2|Participant Flow|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis
Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217759|NCT01315665|P1|Participant Flow|Healthy Volunteers|"Healthy volunteers
Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217760|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days
Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217761|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days
Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217762|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days
Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217763|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days
Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217764|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days
Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217765|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days
Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217766|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days
Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217767|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days
Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217768|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis
Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217769|NCT01315665|O1|Outcome|Healthy Volunteers|"Healthy volunteers
Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217770|NCT01315665|E2|Reported Event|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis
Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217771|NCT01315665|E1|Reported Event|Healthy Volunteers|"Healthy volunteers
Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
217772|NCT01315574|B3|Baseline|Total|Total of all reporting groups
217773|NCT01315574|B2|Baseline|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.
Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
217774|NCT01315574|B1|Baseline|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.
Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
217775|NCT01315574|P2|Participant Flow|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.
Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
218445|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
217777|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.
Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
217778|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.
Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
217779|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.
Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
217780|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.
Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
217781|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.
Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
217782|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.
Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
217783|NCT01315574|E2|Reported Event|Travoprost (Travatan Z)|"7 Patients were be randomized to receive BAK-free Travatan Z for treatment of their glaucoma.
Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
217784|NCT01315574|E1|Reported Event|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.
Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
217785|NCT01315249|B3|Baseline|Total|Total of all reporting groups
217786|NCT01315249|B2|Baseline|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217787|NCT01315249|B1|Baseline|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217788|NCT01315249|P2|Participant Flow|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217789|NCT01315249|P1|Participant Flow|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217790|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217791|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217792|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217793|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217794|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217795|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217796|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217797|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217798|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217799|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217800|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217801|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217802|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217803|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217804|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217805|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217806|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217807|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217808|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217809|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217810|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217811|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217812|NCT01315249|E2|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
217813|NCT01315249|E1|Reported Event|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
217814|NCT01315158|B3|Baseline|Total|Total of all reporting groups
217815|NCT01315158|B2|Baseline|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217846|NCT01315145|E2|Reported Event|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
217872|NCT01314872|B10|Baseline|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
217816|NCT01315158|B1|Baseline|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217817|NCT01315158|P2|Participant Flow|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217818|NCT01315158|P1|Participant Flow|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217819|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217820|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217821|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217822|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217823|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217824|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217825|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217826|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217827|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217828|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217871|NCT01314872|B11|Baseline|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
218446|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
217829|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217830|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217831|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217832|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217833|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217834|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217835|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217836|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217837|NCT01315158|E2|Reported Event|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min"
217838|NCT01315158|E1|Reported Event|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
Recommended Fentanyl
Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed
2. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
217839|NCT01315145|B3|Baseline|Total|Total of all reporting groups
217840|NCT01315145|B2|Baseline|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
217841|NCT01315145|B1|Baseline|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.
Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
217842|NCT01315145|P2|Participant Flow|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
217843|NCT01315145|P1|Participant Flow|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.
Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
217844|NCT01315145|O2|Outcome|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
217845|NCT01315145|O1|Outcome|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.
Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
217847|NCT01315145|E1|Reported Event|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.
Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
217848|NCT01315028|B3|Baseline|Total|Total of all reporting groups
217849|NCT01315028|B2|Baseline|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
217850|NCT01315028|B1|Baseline|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
217851|NCT01315028|P2|Participant Flow|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
217852|NCT01315028|P1|Participant Flow|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
217853|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
217854|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
217855|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
217856|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
217857|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
217858|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
217859|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
217860|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
217861|NCT01315028|E2|Reported Event|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
217862|NCT01315028|E1|Reported Event|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
217863|NCT01315002|B1|Baseline|All Study Participants|Includes groups randomized to receive nicotine first and placebo first. Number of all study participants = 121.
217864|NCT01315002|P2|Participant Flow|Placebo First, Then Nicotine|"Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)
Doses:
non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
217865|NCT01315002|P1|Participant Flow|Nicotine First, Then Placebo|"Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)
Doses:
non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
217866|NCT01315002|O2|Outcome|Placebo Patch|"Placebo patch
Placebo patch: Placebo patch"
217867|NCT01315002|O1|Outcome|Nicotine Patch|"Transdermal nicotine patch
Transdermal nicotine patch: 7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)"
217868|NCT01315002|E2|Reported Event|Placebo First, Then Nicotine|"Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)
Doses:
non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
217869|NCT01315002|E1|Reported Event|Nicotine First, Then Placebo|"Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)
Doses:
non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
217870|NCT01314872|B12|Baseline|Total|Total of all reporting groups
217873|NCT01314872|B9|Baseline|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
217874|NCT01314872|B8|Baseline|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
217875|NCT01314872|B7|Baseline|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
217876|NCT01314872|B6|Baseline|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
217877|NCT01314872|B5|Baseline|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217878|NCT01314872|B4|Baseline|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217879|NCT01314872|B3|Baseline|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217880|NCT01314872|B2|Baseline|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217881|NCT01314872|B1|Baseline|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
217882|NCT01314872|P15|Participant Flow|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
217883|NCT01314872|P14|Participant Flow|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
217884|NCT01314872|P13|Participant Flow|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217885|NCT01314872|P12|Participant Flow|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217886|NCT01314872|P11|Participant Flow|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
217887|NCT01314872|P10|Participant Flow|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
217888|NCT01314872|P9|Participant Flow|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
217889|NCT01314872|P8|Participant Flow|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
217890|NCT01314872|P7|Participant Flow|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
217891|NCT01314872|P6|Participant Flow|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
217892|NCT01314872|P5|Participant Flow|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217893|NCT01314872|P4|Participant Flow|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217894|NCT01314872|P3|Participant Flow|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217895|NCT01314872|P2|Participant Flow|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217896|NCT01314872|P1|Participant Flow|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
217897|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
217898|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
217899|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217900|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217901|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
217902|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
217903|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217904|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217905|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
217906|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
217907|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217908|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217909|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
217910|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
217911|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217962|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217912|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217913|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
217914|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
217915|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217916|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217917|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217918|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217919|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
217920|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
217921|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
217922|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217923|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217924|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217925|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217926|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
217927|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
217928|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
217929|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217930|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217931|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217932|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217933|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
217934|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
217935|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
217936|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
218447|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
217937|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217938|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
217939|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
217940|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217941|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217942|NCT01314872|O11|Outcome|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
217943|NCT01314872|O10|Outcome|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
217944|NCT01314872|O9|Outcome|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
217945|NCT01314872|O8|Outcome|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
217946|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
217947|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
217948|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217949|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217950|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217951|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217952|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
217953|NCT01314872|O11|Outcome|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
217954|NCT01314872|O10|Outcome|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
217955|NCT01314872|O9|Outcome|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
217956|NCT01314872|O8|Outcome|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
217957|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
217958|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
217959|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217960|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217961|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217963|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
217964|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
217965|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
217966|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217967|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217968|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217969|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217970|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
217971|NCT01314872|E15|Reported Event|Extension Study: Vibegron 50 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
217972|NCT01314872|E14|Reported Event|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
217973|NCT01314872|E13|Reported Event|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217974|NCT01314872|E12|Reported Event|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
217975|NCT01314872|E11|Reported Event|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
217976|NCT01314872|E10|Reported Event|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
217977|NCT01314872|E9|Reported Event|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
217978|NCT01314872|E8|Reported Event|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
217979|NCT01314872|E7|Reported Event|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
217980|NCT01314872|E6|Reported Event|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
217981|NCT01314872|E5|Reported Event|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217982|NCT01314872|E4|Reported Event|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217983|NCT01314872|E3|Reported Event|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217984|NCT01314872|E2|Reported Event|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
217985|NCT01314872|E1|Reported Event|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
217986|NCT01314742|B3|Baseline|Total|Total of all reporting groups
217987|NCT01314742|B2|Baseline|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
218040|NCT01314443|E2|Reported Event|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
218448|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
217988|NCT01314742|B1|Baseline|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.
Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
217989|NCT01314742|P2|Participant Flow|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
217990|NCT01314742|P1|Participant Flow|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.
Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
217991|NCT01314742|O2|Outcome|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
217992|NCT01314742|O1|Outcome|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.
Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
217993|NCT01314742|O2|Outcome|Sterile Water Group|Study group receiving timed oral care with Sterile Water
217994|NCT01314742|O1|Outcome|Biotene OralBalance® Gel Arm|Study group receiving timed oral care with Biotene OralBalance® gel Arm
217995|NCT01314742|E2|Reported Event|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
217996|NCT01314742|E1|Reported Event|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.
Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
217997|NCT01314716|B3|Baseline|Total|Total of all reporting groups
217998|NCT01314716|B2|Baseline|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
217999|NCT01314716|B1|Baseline|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218000|NCT01314716|P2|Participant Flow|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days.
218001|NCT01314716|P1|Participant Flow|AZLI-AZLI|Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days.
218002|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218003|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218004|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218005|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218006|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218007|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218041|NCT01314443|E1|Reported Event|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
218252|NCT01313858|B2|Baseline|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
218008|NCT01314716|E4|Reported Event|Placebo-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218009|NCT01314716|E3|Reported Event|AZLI-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218010|NCT01314716|E2|Reported Event|Placebo-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218011|NCT01314716|E1|Reported Event|AZLI-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218012|NCT01314703|B1|Baseline|Group 1|All subjects received treatment with both the test article and the positive control
218013|NCT01314703|P1|Participant Flow|ChloraPrep and 70% Isopropyl Alcohol|All subjects received treatment with both the ChloraPrep and 70% Isopropyl Alcohol
218014|NCT01314703|O2|Outcome|70% Isopropyl Alcohol, 10.5 mL Applicator|All subjects received single application of treatment with 70% Isopropyl Alcohol 10.5 mL Applicator on two treatment sites (abdomen and groin).
218015|NCT01314703|O1|Outcome|ChloraPrep One Step, 10.5 mL Applicator|All subjects received single application of treatment with ChloraPrep One Step 10.5 mL Applicator on two treatment sites (abdomen and groin).
218016|NCT01314703|E1|Reported Event|Group 1|All subjects received treatment with both the test article and the positive control
218017|NCT01314443|B5|Baseline|Total|Total of all reporting groups
218018|NCT01314443|B4|Baseline|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of NRT
218019|NCT01314443|B3|Baseline|Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of NRT
218020|NCT01314443|B2|Baseline|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
218021|NCT01314443|B1|Baseline|Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
218022|NCT01314443|P4|Participant Flow|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
218023|NCT01314443|P3|Participant Flow|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
218024|NCT01314443|P2|Participant Flow|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
218025|NCT01314443|P1|Participant Flow|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
218026|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
218027|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
218028|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
218029|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
218030|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
218031|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
218032|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
218033|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
218034|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
218035|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
218036|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
218037|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
218038|NCT01314443|E4|Reported Event|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
218039|NCT01314443|E3|Reported Event|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
218042|NCT01314417|B1|Baseline|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218043|NCT01314417|P1|Participant Flow|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218044|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218045|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218046|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218047|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218048|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218049|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218050|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218051|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218052|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218053|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218054|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218055|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218056|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218057|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218058|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218059|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218060|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218061|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218062|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218063|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218064|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218065|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218066|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218067|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218068|NCT01314417|E1|Reported Event|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
218069|NCT01314261|B5|Baseline|Total|Total of all reporting groups
218070|NCT01314261|B4|Baseline|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218071|NCT01314261|B3|Baseline|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218072|NCT01314261|B2|Baseline|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218073|NCT01314261|B1|Baseline|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218074|NCT01314261|P4|Participant Flow|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218075|NCT01314261|P3|Participant Flow|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218076|NCT01314261|P2|Participant Flow|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218077|NCT01314261|P1|Participant Flow|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218078|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218079|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218080|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218081|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218082|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218083|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218084|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218085|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218086|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218087|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218088|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218089|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218090|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218091|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218092|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218093|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218094|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218095|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218096|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218097|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218098|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218099|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218100|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218101|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218102|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218103|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218104|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218105|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218106|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218107|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218108|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218109|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218110|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218111|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218112|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218113|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218114|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218115|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218116|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218117|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218118|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218119|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218120|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218121|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218122|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218123|NCT01314261|E4|Reported Event|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218124|NCT01314261|E3|Reported Event|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218125|NCT01314261|E2|Reported Event|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 10 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218126|NCT01314261|E1|Reported Event|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
218127|NCT01314118|B1|Baseline|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
218128|NCT01314118|P1|Participant Flow|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
218129|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
218130|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
218131|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
218132|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
218133|NCT01314118|E1|Reported Event|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
218134|NCT01314105|B3|Baseline|Total|Total of all reporting groups
218135|NCT01314105|B2|Baseline|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218136|NCT01314105|B1|Baseline|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218137|NCT01314105|P2|Participant Flow|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218138|NCT01314105|P1|Participant Flow|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218139|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218140|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218141|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218142|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218143|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218144|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218145|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218146|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218147|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218148|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218149|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218150|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218151|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218152|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218153|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218173|NCT01314001|P4|Participant Flow|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218154|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218155|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218156|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218157|NCT01314105|E2|Reported Event|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218158|NCT01314105|E1|Reported Event|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
218159|NCT01314014|B1|Baseline|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.
Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
218160|NCT01314014|P1|Participant Flow|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.
Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
218161|NCT01314014|O1|Outcome|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.
Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
218162|NCT01314014|O1|Outcome|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.
Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
218163|NCT01314014|E1|Reported Event|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.
Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
218164|NCT01314001|B7|Baseline|Total|Total of all reporting groups
218165|NCT01314001|B6|Baseline|Varenicline (Normal Metabolizers)|"Normal metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218166|NCT01314001|B5|Baseline|Varenicline (Slow Metabolizers)|"Slow metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218167|NCT01314001|B4|Baseline|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218168|NCT01314001|B3|Baseline|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218169|NCT01314001|B2|Baseline|Placebo (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218170|NCT01314001|B1|Baseline|Placebo (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218171|NCT01314001|P6|Participant Flow|Varenicline (Normal Metabolizers)|"Normal metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218172|NCT01314001|P5|Participant Flow|Varenicline (Slow Metabolizers)|"Slow metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218200|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218174|NCT01314001|P3|Participant Flow|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218175|NCT01314001|P2|Participant Flow|Placebo (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218176|NCT01314001|P1|Participant Flow|Placebo (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218177|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218178|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218179|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218180|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218181|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218182|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218183|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218184|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218185|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218186|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218187|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218188|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218189|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218190|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218191|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218192|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218193|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218194|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218195|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218196|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218197|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218198|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218199|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218449|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
218201|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218202|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218203|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218204|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218205|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218206|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218207|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218208|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218209|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218210|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218211|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218212|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218213|NCT01314001|E6|Reported Event|Varenicline (Normal Metabolizers)|"Normal metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218214|NCT01314001|E5|Reported Event|Varenicline (Slow Metabolizers)|"Slow metabolizers
Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
Wearing placebo patches for 11 weeks
Received smoking cessation counseling during their sessions"
218215|NCT01314001|E4|Reported Event|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218216|NCT01314001|E3|Reported Event|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
Received smoking cessation counseling during their sessions"
218217|NCT01314001|E2|Reported Event|Placebo (Normal Metabolizers)|"Normal metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218218|NCT01314001|E1|Reported Event|Placebo (Slow Metabolizers)|"Slow metabolizers
Taking placebo pills daily for 12 weeks
Wearing placebo patches daily for 11 weeks
Received smoking cessation counseling during their sessions"
218219|NCT01313936|B3|Baseline|Total|Total of all reporting groups
218220|NCT01313936|B2|Baseline|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
218221|NCT01313936|B1|Baseline|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
218222|NCT01313936|P2|Participant Flow|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
218223|NCT01313936|P1|Participant Flow|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
218224|NCT01313936|O2|Outcome|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
218225|NCT01313936|O1|Outcome|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
218226|NCT01313936|O2|Outcome|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
218227|NCT01313936|O1|Outcome|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
218228|NCT01313936|E2|Reported Event|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
218229|NCT01313936|E1|Reported Event|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
218230|NCT01313923|B1|Baseline|Sirolimus|All patient will be open-label; Sirolimus. Dosage is variable based on FDA guidelines.
218231|NCT01313923|P1|Participant Flow|Sirolimus|There is one arm to the study. All patients will be open-label, Sirolimus. There is no set dosage: medication dose will be based on FDA approved guidelines.
218232|NCT01313923|O1|Outcome|Sirolimus (Formerly Known as Rapamycin)|No results. Study has been terminated by investigator.
218233|NCT01313923|E1|Reported Event|Sirolimus (Formerly Known as Rapamycin)|No results as study has been terminated early by the investigator.
218234|NCT01313910|B1|Baseline|ImmunoLin®|8-week treatment course
218235|NCT01313910|P1|Participant Flow|ImmunoLin®|2.5 grams twice daily for eight weeks
218236|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
218237|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
218238|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
218239|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
218240|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
218241|NCT01313910|E1|Reported Event|ImmunoLin®|8-week treatment course
218242|NCT01313897|B1|Baseline|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
218243|NCT01313897|P1|Participant Flow|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
218244|NCT01313897|O1|Outcome|Velcade for Anti-MM Therapy|"Day(s) -9,-6,-2 3 doses of Bortezomib at 1.0 mg/m2, i.v.
Bortezomib: bortezomib given days -9, -6, and -2 at 1.0mg/m2, i.v."
218245|NCT01313897|E1|Reported Event|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
218246|NCT01313884|B1|Baseline|Combination Therapy|"Regimen A alternate with Regimen B every 21 days
Regimen A:
Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)
Regimen B:
Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.
Irinotecan: 50 mg/m2/day x 5 days
Vincristine: 2 mg/m2 (capped at 2mg total do)
Temozolomide: 100 mg/m2/day x 5 days
Doxorubicin: 75 mg/m2
Cytoxan: 1200 mg/m2
Pegfilgrastim: 6 mg
Mesna: 240 mg/m2 in 50 ml NS"
218247|NCT01313884|P1|Participant Flow|Combination Therapy|"Regimen A alternate with Regimen B every 21 days
Regimen A:
Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)
Regimen B:
Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.
Irinotecan: 50 mg/m2/day x 5 days
Vincristine: 2 mg/m2 (capped at 2mg total do)
Temozolomide: 100 mg/m2/day x 5 days
Doxorubicin: 75 mg/m2
Cytoxan: 1200 mg/m2
Pegfilgrastim: 6 mg
Mesna: 240 mg/m2 in 50 ml NS"
218248|NCT01313884|O1|Outcome|Combination Therapy|"Regimen A alternate with Regimen B every 21 days
Regimen A:
Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)
Regimen B:
Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.
Irinotecan: 50 mg/m2/day x 5 days
Vincristine: 2 mg/m2 (capped at 2mg total do)
Temozolomide: 100 mg/m2/day x 5 days
Doxorubicin: 75 mg/m2
Cytoxan: 1200 mg/m2
Pegfilgrastim: 6 mg
Mesna: 240 mg/m2 in 50 ml NS"
218249|NCT01313884|E1|Reported Event|Combination Therapy|"Regimen A alternate with Regimen B every 21 days
Regimen A:
Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)
Regimen B:
Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.
Irinotecan: 50 mg/m2/day x 5 days
Vincristine: 2 mg/m2 (capped at 2mg total do)
Temozolomide: 100 mg/m2/day x 5 days
Doxorubicin: 75 mg/m2
Cytoxan: 1200 mg/m2
Pegfilgrastim: 6 mg
Mesna: 240 mg/m2 in 50 ml NS"
218250|NCT01313858|B4|Baseline|Total|Total of all reporting groups
218251|NCT01313858|B3|Baseline|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
218450|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
218253|NCT01313858|B1|Baseline|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
218254|NCT01313858|P3|Participant Flow|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
218255|NCT01313858|P2|Participant Flow|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
218256|NCT01313858|P1|Participant Flow|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
218257|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
218258|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
218259|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
218260|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
218261|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
218262|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
218263|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
218264|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
218265|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
218266|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
218267|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
218268|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
218269|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
218270|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
218271|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
218272|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
218273|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
218274|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
218275|NCT01313858|E1|Reported Event|All Participants|Simponi®-naïve participants with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
218276|NCT01313780|B3|Baseline|Total|Total of all reporting groups
218277|NCT01313780|B2|Baseline|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
218278|NCT01313780|B1|Baseline|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
218279|NCT01313780|P2|Participant Flow|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
218280|NCT01313780|P1|Participant Flow|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
218281|NCT01313780|O2|Outcome|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
218282|NCT01313780|O1|Outcome|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
218283|NCT01313780|O2|Outcome|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
218284|NCT01313780|O1|Outcome|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
218285|NCT01313780|E2|Reported Event|Oxycodone|oxycodone : Trade name is Oxycontin
218286|NCT01313780|E1|Reported Event|Oxycodone and Naloxone|Oxycodone and naloxone: Trade name is TARGIN.
218287|NCT01313728|B1|Baseline|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
218288|NCT01313728|P1|Participant Flow|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
218289|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
218290|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
218291|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
218292|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
218293|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
218294|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
218295|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
218296|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
218297|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
218298|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
218299|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
218300|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
218301|NCT01313728|E1|Reported Event|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
218302|NCT01313689|B3|Baseline|Total|Total of all reporting groups
218303|NCT01313689|B2|Baseline|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218304|NCT01313689|B1|Baseline|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218305|NCT01313689|P4|Participant Flow|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218306|NCT01313689|P3|Participant Flow|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218307|NCT01313689|P2|Participant Flow|Physician's Choice|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218316|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218308|NCT01313689|P1|Participant Flow|Ofatumumab|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218309|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218310|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218311|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218312|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218313|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218314|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218315|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218379|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218451|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
218317|NCT01313689|O3|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218318|NCT01313689|O2|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218319|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218320|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218321|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218322|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218323|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218324|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218380|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218381|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218325|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218326|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218327|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218328|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218329|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218330|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218331|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218332|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218452|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
218453|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
218333|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218334|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218335|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218336|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218337|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218338|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218339|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218340|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218382|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period
218454|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
218341|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218342|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218343|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218344|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218345|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218346|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218347|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218348|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218383|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218455|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
218349|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218350|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218351|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218352|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218353|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218354|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218355|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218356|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218384|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218456|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
218357|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218358|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218359|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218360|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218361|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218362|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218363|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218364|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218385|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218458|NCT01313650|E3|Reported Event|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
218365|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218366|NCT01313689|E4|Reported Event|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218367|NCT01313689|E3|Reported Event|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218368|NCT01313689|E2|Reported Event|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
218369|NCT01313689|E1|Reported Event|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
218370|NCT01313676|B5|Baseline|Total|Total of all reporting groups
218371|NCT01313676|B4|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218372|NCT01313676|B3|Baseline|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218373|NCT01313676|B2|Baseline|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218374|NCT01313676|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218375|NCT01313676|P4|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218376|NCT01313676|P3|Participant Flow|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218377|NCT01313676|P2|Participant Flow|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218378|NCT01313676|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218457|NCT01313650|E4|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
218386|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218387|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218388|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218389|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218390|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218391|NCT01313676|E4|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218392|NCT01313676|E3|Reported Event|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218393|NCT01313676|E2|Reported Event|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218394|NCT01313676|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
218395|NCT01313663|B3|Baseline|Total|Total of all reporting groups
218396|NCT01313663|B2|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218397|NCT01313663|B1|Baseline|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218398|NCT01313663|P2|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218399|NCT01313663|P1|Participant Flow|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218400|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218401|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218402|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218403|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218419|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218404|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218405|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218406|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218407|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218408|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218409|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218410|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218411|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218412|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218413|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218414|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218415|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218416|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218417|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218418|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218444|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
218420|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218421|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218422|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218423|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218424|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218425|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218426|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218427|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218428|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218429|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218430|NCT01313663|E2|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218431|NCT01313663|E1|Reported Event|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
218432|NCT01313650|B5|Baseline|Total|Total of all reporting groups
218433|NCT01313650|B4|Baseline|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
218434|NCT01313650|B3|Baseline|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
218435|NCT01313650|B2|Baseline|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
218436|NCT01313650|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
218437|NCT01313650|P4|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
218438|NCT01313650|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 24 weeks.
218439|NCT01313650|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 24 weeks.
218440|NCT01313650|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
218441|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
218442|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
218443|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
218459|NCT01313650|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
218460|NCT01313650|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
218461|NCT01313637|B5|Baseline|Total|Total of all reporting groups
218462|NCT01313637|B4|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
218463|NCT01313637|B3|Baseline|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
218464|NCT01313637|B2|Baseline|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
218465|NCT01313637|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
218466|NCT01313637|P4|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
218467|NCT01313637|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 24 weeks.
218468|NCT01313637|P2|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD via a DPI in the morning for 24 weeks.
218469|NCT01313637|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
218470|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
218471|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
218472|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
218473|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
218474|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
218475|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
218476|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
218477|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
218478|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
218479|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
218480|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
218481|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
218482|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
218483|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
218484|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
218485|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
218486|NCT01313637|E4|Reported Event|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
218487|NCT01313637|E3|Reported Event|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
218488|NCT01313637|E2|Reported Event|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
218489|NCT01313637|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
218490|NCT01313624|B3|Baseline|Total|Total of all reporting groups
218491|NCT01313624|B2|Baseline|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218492|NCT01313624|B1|Baseline|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218493|NCT01313624|P2|Participant Flow|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218494|NCT01313624|P1|Participant Flow|AZLI-AZLI|Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218495|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218496|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218497|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218498|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218545|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218546|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218499|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218500|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218501|NCT01313624|E4|Reported Event|Placebo-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218502|NCT01313624|E3|Reported Event|AZLI-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218503|NCT01313624|E2|Reported Event|Placebo-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218504|NCT01313624|E1|Reported Event|AZLI-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
218505|NCT01313520|B3|Baseline|Total|Total of all reporting groups
218506|NCT01313520|B2|Baseline|Placebo|saline via intravenous infusion
218507|NCT01313520|B1|Baseline|Infliximab|3 mg/kg of Infliximab intravenous infusion
218508|NCT01313520|P2|Participant Flow|Placebo|saline via intravenous infusion
218509|NCT01313520|P1|Participant Flow|Infliximab|3 mg/kg of Infliximab intravenous infusion
218510|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
218511|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
218512|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
218513|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
218514|NCT01313520|O2|Outcome|Placebo|Saline via intravenous infusion
218515|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
218516|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
218517|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
218518|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
218519|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
218520|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
218521|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
218522|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
218523|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
218524|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
218525|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
218526|NCT01313520|E2|Reported Event|Placebo|saline via intravenous infusion
218527|NCT01313520|E1|Reported Event|Infliximab|3 mg/kg of Infliximab intravenous infusion
218528|NCT01313507|B1|Baseline|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
218529|NCT01313507|P1|Participant Flow|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
218530|NCT01313507|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
218531|NCT01313507|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
218532|NCT01313507|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
218533|NCT01313507|E1|Reported Event|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
218534|NCT01313494|B3|Baseline|Total|Total of all reporting groups
218535|NCT01313494|B2|Baseline|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218536|NCT01313494|B1|Baseline|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218537|NCT01313494|P2|Participant Flow|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218538|NCT01313494|P1|Participant Flow|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218539|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218540|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218541|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218542|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218543|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218544|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218548|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218549|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218550|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218551|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218552|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218553|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218554|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218555|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218556|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218557|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218558|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218559|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218560|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218561|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218562|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218563|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218564|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218565|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218566|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218567|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218568|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218569|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218570|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218571|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218572|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218573|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218574|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218575|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218576|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218577|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218578|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218579|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218580|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218581|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218582|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218583|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218584|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218585|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218586|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218587|NCT01313494|E2|Reported Event|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
218588|NCT01313494|E1|Reported Event|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
218589|NCT01313312|B1|Baseline|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218590|NCT01313312|P1|Participant Flow|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 intramuscular (i.m.) injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218638|NCT01313299|P2|Participant Flow|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
218639|NCT01313299|P1|Participant Flow|Placebo|Placebo intramuscular injection single treatment cycle on day 1
220684|NCT01307020|E6|Reported Event|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
218591|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218592|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218593|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218594|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218595|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218596|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218597|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218640|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
218641|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
218642|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
218643|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
218644|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
218598|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218599|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218600|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218601|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218602|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218603|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218604|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218645|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
218646|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
218647|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
218648|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
218649|NCT01313299|E3|Reported Event|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
218605|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218606|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218607|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218608|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218609|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218610|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218611|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218650|NCT01313299|E2|Reported Event|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
218651|NCT01313299|E1|Reported Event|Placebo|Placebo intramuscular injection single treatment cycle on day 1
218652|NCT01313273|B3|Baseline|Total|Total of all reporting groups
218653|NCT01313273|B2|Baseline|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218612|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218613|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218614|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218615|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218616|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218617|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218618|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218654|NCT01313273|B1|Baseline|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218655|NCT01313273|P2|Participant Flow|Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218658|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218619|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218620|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218621|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218622|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218623|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218624|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218625|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218656|NCT01313273|P1|Participant Flow|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.
218657|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
219107|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
218626|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218627|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218628|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218629|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218630|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218631|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218632|NCT01313312|E1|Reported Event|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.
All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.
From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
218633|NCT01313299|B4|Baseline|Total|Total of all reporting groups
218634|NCT01313299|B3|Baseline|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
218635|NCT01313299|B2|Baseline|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
218636|NCT01313299|B1|Baseline|Placebo|Placebo intramuscular injection single treatment cycle on day 1
218637|NCT01313299|P3|Participant Flow|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
218659|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218660|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218661|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218662|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218663|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218664|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218665|NCT01313273|E2|Reported Event|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218666|NCT01313273|E1|Reported Event|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
218667|NCT01313221|B4|Baseline|Total|Total of all reporting groups
218668|NCT01313221|B3|Baseline|Non-randomized|Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
218669|NCT01313221|B2|Baseline|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218670|NCT01313221|B1|Baseline|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218671|NCT01313221|P3|Participant Flow|Non-randomized|Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
218672|NCT01313221|P2|Participant Flow|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218673|NCT01313221|P1|Participant Flow|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218674|NCT01313221|O2|Outcome|Etanercept + Topical|All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
218675|NCT01313221|O1|Outcome|Etanercept Monotherapy|All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.
218676|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218677|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218678|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218679|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218680|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218681|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218682|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218683|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218684|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218685|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218686|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218687|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218688|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218689|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218690|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218691|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218692|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218693|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218694|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218695|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218696|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218697|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218698|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218699|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218700|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218701|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218702|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218703|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218704|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218705|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218706|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218707|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218708|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218709|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218710|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218711|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218712|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218713|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218714|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218715|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218716|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218717|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218718|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
218719|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
218720|NCT01313221|E2|Reported Event|Etanercept + Topical|All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
218721|NCT01313221|E1|Reported Event|Etanercept Monotherapy|All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.
218722|NCT01313208|B3|Baseline|Total|Total of all reporting groups
218756|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218723|NCT01313208|B2|Baseline|Etanercept|"Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.
All participants continued their DMARD treatment throughout the 24-week study period."
218724|NCT01313208|B1|Baseline|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
218725|NCT01313208|P2|Participant Flow|Etanercept|"Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.
All participants continued their DMARD treatment throughout the 24-week study period."
218726|NCT01313208|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
218727|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218728|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218729|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218730|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218731|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218732|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218733|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218734|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218735|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218736|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218737|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218738|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218739|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218740|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218741|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218742|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218743|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218744|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218745|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218746|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218747|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218748|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218749|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218750|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218751|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218752|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218753|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218754|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218755|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
220685|NCT01307020|E5|Reported Event|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
218757|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218758|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218759|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218760|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218761|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218762|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218763|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218764|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218765|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218766|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218767|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218768|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218769|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218770|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218771|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218772|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218773|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218774|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218775|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218776|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218777|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218778|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218779|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218780|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218781|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218782|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218783|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218784|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218785|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218786|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218787|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218788|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218789|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218790|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218791|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218867|NCT01312948|B1|Baseline|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
218792|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218793|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218794|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218795|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218796|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218797|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218798|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218799|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218800|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218801|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218802|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218803|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218804|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218805|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
218806|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
218807|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
218808|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks.
218809|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
218810|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks.
218811|NCT01313208|E2|Reported Event|Etanercept-Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks. All participants continued their DMARD treatment throughout the 24-week study period.
218812|NCT01313208|E1|Reported Event|Placebo-Etanercept|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
218813|NCT01313182|B3|Baseline|Total|Total of all reporting groups
218814|NCT01313182|B2|Baseline|Bactroban Nasal|"Mupirocin calcium ointment, 2%
mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
218815|NCT01313182|B1|Baseline|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
218816|NCT01313182|P2|Participant Flow|Bactroban Nasal|"Mupirocin calcium ointment, 2%
mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
218817|NCT01313182|P1|Participant Flow|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
218818|NCT01313182|O2|Outcome|Bactroban Nasal|"Mupirocin calcium ointment, 2%
mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
218819|NCT01313182|O1|Outcome|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
218820|NCT01313182|E2|Reported Event|Bactroban Nasal|"Mupirocin calcium ointment, 2%
mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
218821|NCT01313182|E1|Reported Event|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
218822|NCT01313117|B1|Baseline|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)
Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
218823|NCT01313117|P1|Participant Flow|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)
Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
218824|NCT01313117|O1|Outcome|Alpha Lipoic Acid|The study was designed to first explore the optimal ALA dose. The baseline dose was 100 mg three times daily for four months. Dose escalation was to occur until a maximum tolerated dose (MTD) was found. Once the MTD was established we were then to enroll additional patients at the MTD for efficacy analysis. The study failed to reach the MTD. Only small numbers of patients were enrolled. As such, we were unable to perform any meaningful efficacy (TNS) analysis.
218825|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)
Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
218826|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)
Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
218827|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)
Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
218828|NCT01313117|E1|Reported Event|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)
Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
218829|NCT01313078|B1|Baseline|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
218830|NCT01313078|P1|Participant Flow|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
218831|NCT01313078|O1|Outcome|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
218832|NCT01313078|O1|Outcome|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
218833|NCT01313078|E1|Reported Event|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
218834|NCT01313039|B1|Baseline|AZD6244|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
218835|NCT01313039|P1|Participant Flow|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
218836|NCT01313039|O1|Outcome|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
218837|NCT01313039|E1|Reported Event|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
218838|NCT01312961|B3|Baseline|Total|Total of all reporting groups
218839|NCT01312961|B2|Baseline|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218840|NCT01312961|B1|Baseline|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol were given as rescue medication.
218841|NCT01312961|P2|Participant Flow|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218842|NCT01312961|P1|Participant Flow|Placebo (for Dupilumab)|Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol were given as rescue medication.
218843|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218844|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218845|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218868|NCT01312948|P1|Participant Flow|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
221441|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
218846|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218847|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218848|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218849|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218850|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218851|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218852|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218853|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218854|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218855|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218856|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218857|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218858|NCT01312961|O1|Outcome|Placebo|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218859|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218860|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218861|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218862|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218863|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218864|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
218865|NCT01312961|E2|Reported Event|Dupilumab 300 mg qw|Participants exposed to Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks).
218866|NCT01312961|E1|Reported Event|Placebo (for Dupilumab)|Participants exposed to Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks).
218869|NCT01312948|O2|Outcome|Usual Mask|Apnea hypopnoea index from a monitored sleep study of the child's usual CPAP mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
218870|NCT01312948|O1|Outcome|Pixi Paediatric Mask|Apnea hypopnoea index from a monitored sleep study of the new Pixi mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
218871|NCT01312948|O2|Outcome|Usual Mask|Usability (overall performance) score of the child's usual CPAP mask
218872|NCT01312948|O1|Outcome|Pixi Paediatric Mask Usability|Usability (overall performance) score of the Pixi paediatric mask
218873|NCT01312948|E1|Reported Event|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
218874|NCT01312844|B3|Baseline|Total|Total of all reporting groups
218875|NCT01312844|B2|Baseline|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218876|NCT01312844|B1|Baseline|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218877|NCT01312844|P2|Participant Flow|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218878|NCT01312844|P1|Participant Flow|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218879|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218880|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218881|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218882|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218883|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218884|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218885|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218886|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218887|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218888|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218889|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218890|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218891|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218892|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218893|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218894|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218895|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218896|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218897|NCT01312844|E2|Reported Event|Placebo|"Patients receiving IV placebo at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218898|NCT01312844|E1|Reported Event|Scopolamine|"Patients receiving IV scopolamine at ECT treatment
Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
218899|NCT01312818|B1|Baseline|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.
Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.
Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14
Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.
Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)
Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:
Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
218927|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218928|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218929|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218900|NCT01312818|P1|Participant Flow|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.
Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.
Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14
Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.
Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)
Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:
Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
218901|NCT01312818|O1|Outcome|Chemotherapy|"Bortezomib IV Vorinostat PO Dexamethasone PO Intrathecal Methotrexate Imatinib Mesylate PO (for Ph+ ALL patients only)
Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.
Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14
Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.
Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)
Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:
Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
218902|NCT01312818|O1|Outcome|ALL Treated Patients|"List of toxicities in acute lymphoblastic leukemia (ALL) patients treated with bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.
Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.
Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14
Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.
Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)
Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:
Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
218903|NCT01312818|O1|Outcome|ALL Treated Patients|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.
Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.
Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14
Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.
Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)
Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:
Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
218904|NCT01312818|E1|Reported Event|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.
Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.
Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14
Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.
Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)
Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:
Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
218905|NCT01312805|B3|Baseline|Total|Total of all reporting groups
218906|NCT01312805|B2|Baseline|CHICA Asthma Module|"This arm received the CHICA asthma module
CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
218907|NCT01312805|B1|Baseline|CHICA Control|"This arm received CHICA without the asthma module
CHICA Control: This is CHICA without the asthma module, and was used as a control"
218908|NCT01312805|P2|Participant Flow|CHICA Asthma Module|"This arm received the CHICA asthma module
CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
218909|NCT01312805|P1|Participant Flow|CHICA Control|"This arm received CHICA without the asthma module
CHICA Control: This is CHICA without the asthma module, and was used as a control"
218910|NCT01312805|O2|Outcome|CHICA Asthma Module|"This arm received the CHICA asthma module
CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
218911|NCT01312805|O1|Outcome|CHICA Control|"This arm received CHICA without the asthma module
CHICA Control: This is CHICA without the asthma module, and was used as a control"
218912|NCT01312805|E2|Reported Event|CHICA Asthma Module|"This arm received the CHICA asthma module
CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
218913|NCT01312805|E1|Reported Event|CHICA Control|"This arm received CHICA without the asthma module
CHICA Control: This is CHICA without the asthma module, and was used as a control"
218914|NCT01312766|B3|Baseline|Total|Total of all reporting groups
218915|NCT01312766|B2|Baseline|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218916|NCT01312766|B1|Baseline|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218917|NCT01312766|P2|Participant Flow|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218918|NCT01312766|P1|Participant Flow|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218919|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218920|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218921|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218922|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218923|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218924|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218925|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218926|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218930|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218931|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218932|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218933|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218934|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218935|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218936|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218937|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218938|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218939|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218940|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218941|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218942|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218943|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218944|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218945|NCT01312766|E2|Reported Event|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
218946|NCT01312766|E1|Reported Event|hMG-IBSA|"New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
218947|NCT01312519|B3|Baseline|Total|Total of all reporting groups
218948|NCT01312519|B2|Baseline|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
218949|NCT01312519|B1|Baseline|Manual Bone Marrow Sampling Device|Hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
218950|NCT01312519|P2|Participant Flow|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
218951|NCT01312519|P1|Participant Flow|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
218952|NCT01312519|O2|Outcome|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
218953|NCT01312519|O1|Outcome|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
218954|NCT01312519|O2|Outcome|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
218955|NCT01312519|O1|Outcome|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
218956|NCT01312519|E2|Reported Event|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
218957|NCT01312519|E1|Reported Event|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
218958|NCT01312467|B1|Baseline|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
218959|NCT01312467|P1|Participant Flow|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
218960|NCT01312467|O1|Outcome|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
218961|NCT01312467|E1|Reported Event|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
218962|NCT01312428|B3|Baseline|Total|Total of all reporting groups
218963|NCT01312428|B2|Baseline|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.
Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
218964|NCT01312428|B1|Baseline|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.
Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
219102|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
218965|NCT01312428|P2|Participant Flow|No PAL (No Pelvic Alignment Level)|"The cases randomized into the No PAL Group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.
Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
218966|NCT01312428|P1|Participant Flow|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL Group will have total hip replacement surgery performed utilizing the PAL instrument.
Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
218967|NCT01312428|O2|Outcome|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.
Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
218968|NCT01312428|O1|Outcome|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.
Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
218969|NCT01312428|E2|Reported Event|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.
Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
218970|NCT01312428|E1|Reported Event|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.
Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
218971|NCT01312272|B3|Baseline|Total|Total of all reporting groups
218972|NCT01312272|B2|Baseline|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
218973|NCT01312272|B1|Baseline|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
218974|NCT01312272|P2|Participant Flow|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
218975|NCT01312272|P1|Participant Flow|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
218976|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
218977|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
218978|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
218979|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
218980|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
218981|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
218982|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
218983|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
219103|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219104|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
218984|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
218985|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
218986|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
218987|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
218988|NCT01312272|E2|Reported Event|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
218989|NCT01312272|E1|Reported Event|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
218990|NCT01312129|B3|Baseline|Total|Total of all reporting groups
218991|NCT01312129|B2|Baseline|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
218992|NCT01312129|B1|Baseline|Placebo First, Then Sulfasalazine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
218993|NCT01312129|P2|Participant Flow|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
218994|NCT01312129|P1|Participant Flow|Placebo First, Then Sulfasalzine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
218995|NCT01312129|O2|Outcome|Sulfasalazine|Sulfasalazine capsule, 500mg, x 3 doses 12 hours.
218996|NCT01312129|O1|Outcome|Placebo|Placebo x 3 doses 12 hours apart
218997|NCT01312129|E2|Reported Event|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
218998|NCT01312129|E1|Reported Event|Placebo First, Then Sulfasalazine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
218999|NCT01312038|B3|Baseline|Total|Total of all reporting groups
219000|NCT01312038|B2|Baseline|Placebo|"chewable calcium tablet
Placebo: chewable calcium tablet"
219001|NCT01312038|B1|Baseline|Simethicone|"125 mg tablet
Simethicone: single 125 mg chewable tablet"
219002|NCT01312038|P2|Participant Flow|Placebo|"chewable calcium tablet
Placebo: chewable calcium tablet"
219003|NCT01312038|P1|Participant Flow|Simethicone|"125 mg tablet
Simethicone: single 125 mg chewable tablet"
219004|NCT01312038|O2|Outcome|Placebo|Outcome measure in each evaluable ear
219005|NCT01312038|O1|Outcome|Simethicone-treated|Outcome measure in each evaluable ear.
219006|NCT01312038|E2|Reported Event|Placebo|"chewable calcium tablet
Placebo: chewable calcium tablet"
219007|NCT01312038|E1|Reported Event|Simethicone|"125 mg tablet
Simethicone: single 125 mg chewable tablet"
219008|NCT01311687|B3|Baseline|Total|Total of all reporting groups
219009|NCT01311687|B2|Baseline|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219010|NCT01311687|B1|Baseline|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219011|NCT01311687|P2|Participant Flow|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219012|NCT01311687|P1|Participant Flow|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219013|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219212|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219014|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219015|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219016|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219017|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219018|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219019|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219020|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219021|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219022|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219023|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219024|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219025|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219026|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219027|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219028|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219029|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219030|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219031|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219032|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219033|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219034|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219035|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219105|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219036|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219037|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219038|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219039|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219040|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219041|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219042|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219043|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219044|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219045|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219046|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219047|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219048|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219049|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219050|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219051|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219052|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219053|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219054|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219055|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219056|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219057|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219106|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219058|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219059|NCT01311687|E2|Reported Event|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
219060|NCT01311687|E1|Reported Event|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
219061|NCT01311661|B1|Baseline|Study Total|This was a double-blind, 3-period crossover trial. 206 patients were assigned randomly to one of 12 treatment sequences with either 5 microgram (mcg) Olodaterol (Olo) once daily (qd) and 2.5 mcg Olodaterol twice daily (bid) and placebo (6 sequences) or 10 mcg Olodaterol qd and 5 mcg Olodaterol bid and placebo (6 sequences). The duration of each treatment period was 3 weeks separated by washout periods of 2 weeks.
219062|NCT01311661|P1|Participant Flow|Study Total|This was a double-blind, 3-period crossover trial. 206 patients were assigned randomly to one of 12 treatment sequences with either 5 microgram (mcg) Olodaterol (Olo) once daily (qd) and 2.5 mcg Olodaterol twice daily (bid) and placebo (6 sequences) or 10 mcg Olodaterol qd and 5 mcg Olodaterol bid and placebo (6 sequences). The duration of each treatment period was 3 weeks separated by washout periods of 2 weeks.
219063|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219064|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219065|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219066|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219067|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219068|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219069|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219070|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219071|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219072|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219073|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219074|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219075|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219076|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219077|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219078|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219079|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219080|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219081|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219082|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219083|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219084|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219085|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219086|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219087|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219088|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219089|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219090|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219091|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219092|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219093|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219094|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219095|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219096|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219097|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219098|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219099|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219100|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219101|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219108|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219109|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219110|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219111|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219112|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219113|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219114|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219115|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219116|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219117|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219118|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219119|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219120|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219121|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219122|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219123|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219124|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219125|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219126|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219127|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219128|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219129|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219130|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219131|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219132|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219133|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219134|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219135|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219136|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219137|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219138|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219139|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219140|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219141|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219142|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219143|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219144|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219145|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219146|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219147|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219148|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219149|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219150|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219151|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219152|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219153|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219154|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219155|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219156|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219157|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219158|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219159|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
221442|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
219160|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219161|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219162|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219163|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219164|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219165|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219166|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219167|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219168|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219169|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219170|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219171|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219172|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219173|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219174|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219175|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219176|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219177|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219178|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219179|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219180|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219181|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219182|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219183|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219184|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219185|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219186|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219187|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219188|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219189|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219190|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219191|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219192|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219193|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219194|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219195|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219196|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219197|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219198|NCT01311661|E5|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219199|NCT01311661|E4|Reported Event|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
219200|NCT01311661|E3|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
219201|NCT01311661|E2|Reported Event|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
219202|NCT01311661|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
219203|NCT01311557|B3|Baseline|Total|Total of all reporting groups
219204|NCT01311557|B2|Baseline|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219205|NCT01311557|B1|Baseline|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219206|NCT01311557|P2|Participant Flow|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219207|NCT01311557|P1|Participant Flow|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219208|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219209|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219210|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219211|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
221443|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
219213|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219214|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219215|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219216|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219217|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219218|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219219|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219220|NCT01311557|E2|Reported Event|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219221|NCT01311557|E1|Reported Event|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
219222|NCT01311505|B1|Baseline|Participants Eligible for Analysis|Includes participants randomized to receive Myrin 2 first and Rimactane first and who had completed the study. It excludes 1 participant who did not meet the weight requirement for the study (protocol violator).
219223|NCT01311505|P2|Participant Flow|Rimactane First, Then Myrin 2|Single oral dose of Rimactane capsule (300 mg rifampicin) in first intervention period; and single oral dose of 2 FDC tablets of Myrin 2 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) in second intervention period. A washout period of at least 7 days was maintained between each period.
219224|NCT01311505|P1|Participant Flow|Myrin 2 First, Then Rimactane|Single oral dose of 2 fixed dose combination (FDC) tablets of Myrin 2 (each tablet contains 150 milligram (mg) rifampicin and 75 mg isoniazid) in first intervention period, and single oral dose of Rimactane capsule (300 mg rifampicin) in second intervention period. A washout period of at least 7 days was maintained between each period.
219225|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
219226|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
219227|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
219228|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
219229|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
219230|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
219231|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
219232|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
219233|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
219234|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
219235|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
219236|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
219237|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
219238|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
219239|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
219240|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
219241|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
219242|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
219243|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
219244|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
219245|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg capsule) in either first intervention period or second intervention period.
219246|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
219247|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
219248|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
220107|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
219249|NCT01311505|E2|Reported Event|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
219250|NCT01311505|E1|Reported Event|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
219251|NCT01311362|B1|Baseline|Ambrisentan|administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
219252|NCT01311362|P1|Participant Flow|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
219253|NCT01311362|O3|Outcome|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
219254|NCT01311362|O2|Outcome|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
219255|NCT01311362|O1|Outcome|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
219256|NCT01311362|O3|Outcome|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg t.i.d. on day 11-20
219257|NCT01311362|O2|Outcome|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
219258|NCT01311362|O1|Outcome|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
219259|NCT01311362|E3|Reported Event|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
219260|NCT01311362|E2|Reported Event|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
219261|NCT01311362|E1|Reported Event|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
219262|NCT01311102|B3|Baseline|Total|Total of all reporting groups
219263|NCT01311102|B2|Baseline|Normal Saline|Normal Saline : 1.33cc of normal saline
219264|NCT01311102|B1|Baseline|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
219265|NCT01311102|P2|Participant Flow|Normal Saline|Normal Saline : 1.33cc of normal saline
219266|NCT01311102|P1|Participant Flow|Lidocaine|Lidocaine : 1.33 cc of 2% liquid lidocaine
219267|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline infused in endo cervix and endometrium.
219268|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine infused in endo cervix and endometrium
219269|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
219270|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
219271|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
219272|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
219273|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
219274|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
219275|NCT01311102|E2|Reported Event|Normal Saline|Normal Saline : 1.33cc of normal saline
219276|NCT01311102|E1|Reported Event|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
219277|NCT01311024|B3|Baseline|Total|Total of all reporting groups
219278|NCT01311024|B2|Baseline|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)"
219279|NCT01311024|B1|Baseline|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)"
219280|NCT01311024|P2|Participant Flow|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
219281|NCT01311024|P1|Participant Flow|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).
Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
219282|NCT01311024|O2|Outcome|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
219313|NCT01309919|B1|Baseline|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)
IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.
Diary: Subjects will keep a bleeding diary for three months"
219359|NCT01310777|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
219283|NCT01311024|O1|Outcome|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).
Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
219284|NCT01311024|E2|Reported Event|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
219285|NCT01311024|E1|Reported Event|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).
Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
219286|NCT01309997|B3|Baseline|Total|Total of all reporting groups
219287|NCT01309997|B2|Baseline|Arm II (Monoclonal Antibody)|Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. TDuring the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
219288|NCT01309997|B1|Baseline|Arm I (Enzyme Inhibitor)|Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
219289|NCT01309997|P2|Participant Flow|Arm II (Monoclonal Antibody)|Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
219290|NCT01309997|P1|Participant Flow|Arm I (Enzyme Inhibitor)|Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
219291|NCT01309997|O4|Outcome|Imatinib Nonresponders|Did not attain a SCR with imatinib
219292|NCT01309997|O3|Outcome|Imatinib Responders|Attained a SCR with imatinib
219293|NCT01309997|O2|Outcome|Rituximab Non-responders|Did not attain a SCR with rituximab
219294|NCT01309997|O1|Outcome|Rituximab Responders|Attained a SCR with rituximab
219295|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
219296|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
219297|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
219298|NCT01309997|O1|Outcome|Arm 1 (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
219299|NCT01309997|O2|Outcome|Arm II (Monocolonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
219300|NCT01309997|O1|Outcome|Arm 1 (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
219301|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
219302|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
219303|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
219304|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate as their first therapy. They may take this from 1 mo-18 mo.
219305|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
219306|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
219307|NCT01309997|E4|Reported Event|Rituximab as Secondary Therapy|Arm II = rituximab, adverse event occurred after the start date of rituximab. (All participants in this group received imatinib prior).
219308|NCT01309997|E3|Reported Event|Imatinib as Secondary Therapy|Arm II = imatinib, adverse event occurred after the start date of imatinib. (All participants in this group received rituximab prior).
219309|NCT01309997|E2|Reported Event|Rituximab as Initial Therapy|Arm I = rituximab, adverse event occurred after the start date of rituximab and if applicable, prior to start date of imatinib.
219310|NCT01309997|E1|Reported Event|Imatinib as Initial Therapy|Arm I = imatinib, adverse event occurred after the start date of imatinib and if applicable, prior to start date of rituximab.
219311|NCT01309919|B3|Baseline|Total|Total of all reporting groups
219312|NCT01309919|B2|Baseline|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all
Diary: Subjects will keep a bleeding diary for three months"
221662|NCT01303224|P1|Participant Flow|Ibodutant 1 mg|oral tablet, once daily
219314|NCT01309919|P2|Participant Flow|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all
Diary: Subjects will keep a bleeding diary for three months"
219315|NCT01309919|P1|Participant Flow|Intrauterine Device (IUD) Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)
IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.
Diary: Subjects will keep a bleeding diary for three months"
219316|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all
Diary: Subjects will keep a bleeding diary for three months"
219317|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)
IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.
Diary: Subjects will keep a bleeding diary for three months"
219318|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all
Diary: Subjects will keep a bleeding diary for three months"
219319|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)
IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.
Diary: Subjects will keep a bleeding diary for three months"
219320|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all
Diary: Subjects will keep a bleeding diary for three months"
219321|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)
IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.
Diary: Subjects will keep a bleeding diary for three months"
219322|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all
Diary: Subjects will keep a bleeding diary for three months"
219323|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)
IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.
Diary: Subjects will keep a bleeding diary for three months"
219324|NCT01309919|E2|Reported Event|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all
Diary: Subjects will keep a bleeding diary for three months"
219325|NCT01309919|E1|Reported Event|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)
IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.
Diary: Subjects will keep a bleeding diary for three months"
219326|NCT01310868|B1|Baseline|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.
5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers
Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
219327|NCT01310868|P1|Participant Flow|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.
5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers
Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
219328|NCT01310868|O1|Outcome|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.
5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers
Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
219329|NCT01310868|E1|Reported Event|5-ALA and Gliadel Wafers|"This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.
5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers
Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection."
219330|NCT01310855|B3|Baseline|Total|Total of all reporting groups
219331|NCT01310855|B2|Baseline|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.
cediranib maleate
Placebo"
219332|NCT01310855|B1|Baseline|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.
cediranib maleate
gefitinib"
219358|NCT01310777|O2|Outcome|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
220108|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
219333|NCT01310855|P2|Participant Flow|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.
cediranib maleate
Placebo"
219334|NCT01310855|P1|Participant Flow|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.
cediranib maleate
gefitinib"
219335|NCT01310855|O2|Outcome|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.
cediranib maleate
Placebo"
219336|NCT01310855|O1|Outcome|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.
cediranib maleate
gefitinib"
219337|NCT01310855|E2|Reported Event|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.
Due to the early discontinuation of Cediranib by AZ, the trial was discontinued early so that only 38 patients (19 per arm) were recruited."
219338|NCT01310855|E1|Reported Event|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.
Due to the early discontinuation of Cediranib by AZ, the trial was discontinued early so that only 38 patients (19 per arm) were recruited. One patient in the Cediranib arm did not complete their patient diary, and it was not known how much of the trial treatment they had. Therefore the adverse events reported by the patient could not be attributed to the trial treatment and they were excluded from all analyses."
219339|NCT01310803|B3|Baseline|Total|Total of all reporting groups
219340|NCT01310803|B2|Baseline|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
219341|NCT01310803|B1|Baseline|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)
VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
219342|NCT01310803|P2|Participant Flow|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
219343|NCT01310803|P1|Participant Flow|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)
VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
219344|NCT01310803|O2|Outcome|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
219345|NCT01310803|O1|Outcome|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)
VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
219346|NCT01310803|O2|Outcome|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
219347|NCT01310803|O1|Outcome|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)
VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
219348|NCT01310803|E2|Reported Event|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
219349|NCT01310803|E1|Reported Event|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)
VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
219350|NCT01310777|B4|Baseline|Total|Total of all reporting groups
219351|NCT01310777|B3|Baseline|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
219352|NCT01310777|B2|Baseline|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
219353|NCT01310777|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
219354|NCT01310777|P3|Participant Flow|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
219355|NCT01310777|P2|Participant Flow|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
219356|NCT01310777|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
219357|NCT01310777|O3|Outcome|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
221663|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
219360|NCT01310777|E3|Reported Event|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
219361|NCT01310777|E2|Reported Event|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
219362|NCT01310777|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
219363|NCT01310699|B3|Baseline|Total|Total of all reporting groups
219364|NCT01310699|B2|Baseline|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219365|NCT01310699|B1|Baseline|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219366|NCT01310699|P2|Participant Flow|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219367|NCT01310699|P1|Participant Flow|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219368|NCT01310699|O2|Outcome|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219369|NCT01310699|O1|Outcome|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219370|NCT01310699|O2|Outcome|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219371|NCT01310699|O1|Outcome|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219372|NCT01310699|O2|Outcome|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219373|NCT01310699|O1|Outcome|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219374|NCT01310699|E2|Reported Event|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219375|NCT01310699|E1|Reported Event|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
219376|NCT01310582|B3|Baseline|Total|Total of all reporting groups
219377|NCT01310582|B2|Baseline|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
219378|NCT01310582|B1|Baseline|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
219379|NCT01310582|P2|Participant Flow|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
219380|NCT01310582|P1|Participant Flow|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
219381|NCT01310582|O2|Outcome|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
219382|NCT01310582|O1|Outcome|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
219383|NCT01310582|O2|Outcome|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
219384|NCT01310582|O1|Outcome|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
220109|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
221664|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
219385|NCT01310582|E2|Reported Event|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
219386|NCT01310582|E1|Reported Event|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
219387|NCT01310413|B7|Baseline|Total|Total of all reporting groups
219388|NCT01310413|B6|Baseline|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219389|NCT01310413|B5|Baseline|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219390|NCT01310413|B4|Baseline|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219391|NCT01310413|B3|Baseline|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219392|NCT01310413|B2|Baseline|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219393|NCT01310413|B1|Baseline|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219394|NCT01310413|P7|Participant Flow|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219395|NCT01310413|P6|Participant Flow|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219396|NCT01310413|P5|Participant Flow|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219397|NCT01310413|P4|Participant Flow|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219398|NCT01310413|P3|Participant Flow|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219519|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
221665|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
219399|NCT01310413|P2|Participant Flow|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219400|NCT01310413|P1|Participant Flow|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219401|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219402|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219403|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219404|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219405|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219406|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219407|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219408|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219409|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219410|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and PInfluenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219411|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219412|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219413|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219414|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219415|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219450|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219572|NCT01310400|E2|Reported Event|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
221666|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
219416|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219417|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219418|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219419|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219420|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219421|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219422|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219423|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219451|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219573|NCT01310400|E1|Reported Event|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
221667|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
219424|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219425|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219426|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219427|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219428|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219429|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219430|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219431|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219465|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219597|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens
Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
219432|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219433|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219434|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219435|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219436|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219437|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219438|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219439|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219466|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219598|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens
Investigational Lens: Lenses worn on a daily wear basis for one week"
221668|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
219440|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219441|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219442|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219443|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219444|NCT01310413|O1|Outcome|Placebo/Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219445|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219446|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219447|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219448|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219449|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219452|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219453|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219454|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219455|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219456|NCT01310413|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219457|NCT01310413|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219458|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219459|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219460|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219461|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219462|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219463|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219464|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
221669|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
219467|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219468|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219469|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219470|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219471|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219472|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219473|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219474|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219475|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219476|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219477|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219478|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219479|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219599|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens
Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
221670|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
219480|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219481|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219482|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219483|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219484|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219485|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219486|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219487|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219488|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219489|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219490|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219491|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219492|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219600|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens
Investigational Lens: Lenses worn on a daily wear basis for one week"
220110|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
219493|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219494|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219495|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219496|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219497|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219498|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219499|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|SSubjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219500|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219501|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219502|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219503|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219504|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219505|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219601|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens
Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
220111|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
219506|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219507|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219508|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219509|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219510|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219511|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219512|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219513|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219514|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219515|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219516|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219517|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219518|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
220112|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
219520|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219521|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219522|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219523|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219524|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219525|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219526|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219527|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219528|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219529|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219530|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219531|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219532|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219602|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens
Investigational Lens: Lenses worn on a daily wear basis for one week"
219603|NCT01309893|E2|Reported Event|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens
Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
220113|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
219533|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219534|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219535|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219536|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219537|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219538|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219539|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219540|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219541|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219542|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219543|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219544|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219545|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219604|NCT01309893|E1|Reported Event|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens
Investigational Lens: Lenses worn on a daily wear basis for one week"
221671|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
219546|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219547|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219548|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219549|NCT01310413|E3|Reported Event|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6≤36M, Placebo 3≤9Y or Placebo 9≤18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6≤36M, Placebo 3≤9Y and Placebo 9≤18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
219550|NCT01310413|E2|Reported Event|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219551|NCT01310413|E1|Reported Event|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3≤9Y and Influenza A (H5N1) adjuvanted 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
219552|NCT01310400|B4|Baseline|Total|Total of all reporting groups
219553|NCT01310400|B3|Baseline|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
219554|NCT01310400|B2|Baseline|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
219555|NCT01310400|B1|Baseline|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
219556|NCT01310400|P3|Participant Flow|Agrippal 0.25 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
219557|NCT01310400|P2|Participant Flow|Inflexal V 0.25 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
219558|NCT01310400|P1|Participant Flow|Inflexal V 0.5 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
219559|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
219560|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
219561|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
219562|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
219563|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
219564|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
219565|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
219566|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
219567|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
219568|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
219569|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
219570|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
219571|NCT01310400|E3|Reported Event|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
219574|NCT01310179|B1|Baseline|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days.
Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
219575|NCT01310179|P1|Participant Flow|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days.
Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
219576|NCT01310179|O1|Outcome|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first three cohorts will receive 3x10e11 VP for 3 injections and 5, 15 or 25 mg/m2 of F-araAMP daily for 3 days. Subject in the fourth cohort will receive 3x10e12 VP for 3 injections and the highest tolerated dose of F-araAMP daily for 3 days.
Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
219577|NCT01310179|O1|Outcome|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first three cohorts will receive 3x10e11 VP for 3 injections and 5, 15 or 25 mg/m2 of F-araAMP daily for 3 days. Subject in the fourth cohort will receive 3x10e12 VP for 3 injections and the highest tolerated dose of F-araAMP daily for 3 days.
Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
219578|NCT01310179|E1|Reported Event|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days..
Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
219579|NCT01310127|B3|Baseline|Total|Total of all reporting groups
219580|NCT01310127|B2|Baseline|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
219581|NCT01310127|B1|Baseline|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
219582|NCT01310127|P2|Participant Flow|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
219583|NCT01310127|P1|Participant Flow|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
219584|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
219585|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
219586|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
219587|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
219588|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
219589|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
219590|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
219591|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
219592|NCT01310127|E2|Reported Event|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
219593|NCT01310127|E1|Reported Event|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
219594|NCT01309893|B1|Baseline|Entire Study Population|All eligible enrolled participants
219595|NCT01309893|P2|Participant Flow|Air Optix Aqua Lens First, Then Investigational Lens|Enrolled participants spent 1 week using Air Optix Aqua Lens, and then crossed over to 1 week using Investigational Lens. The order of contact lens use was randomized and participant-masked.
219596|NCT01309893|P1|Participant Flow|Investigational Lens First, Then Air Optix Aqua Lens|Enrolled participants spent 1 week using Investigational Lens, and then crossed over to 1 week using Air Optix Aqua lens. The order of contact lens use was randomized and participant-masked.
221672|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
219605|NCT01309880|B1|Baseline|Overall Study|One-half of the participants (33) were randomized to receive the investigational RD2117-01 ID4 contact lens, and the other half (33) was randomized to receive the Air Optix Aqua contact lens. Both groups wore the lenses on a daily wear basis. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week.
219606|NCT01309880|P2|Participant Flow|Test Lens Then Air Optix Aqua|The test lens was an Investigational silicone hydrogel contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to Ciba Vision Air Optix Aqua contact lens.. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
219607|NCT01309880|P1|Participant Flow|Air Optix Aqua Then Test Lens|Ciba Vision Air Optix Aqua contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to the Test lens. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
219608|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens
Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
219609|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens
Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
219610|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens
Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
219611|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens
Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
219612|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens
Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
219613|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens
Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
219614|NCT01309880|E2|Reported Event|Test Lens|"Investigational silicone hydrogel contact lens
Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
219615|NCT01309880|E1|Reported Event|Air Optix Aqua|"Ciba Vision daily wear contact lens
Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
219616|NCT01309841|B4|Baseline|Total|Total of all reporting groups
219617|NCT01309841|B3|Baseline|Placebo|Placebo QD, oral treatment
219618|NCT01309841|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219619|NCT01309841|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219620|NCT01309841|P3|Participant Flow|Placebo|Placebo QD, oral treatment
219621|NCT01309841|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219622|NCT01309841|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219623|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
219624|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219625|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219626|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
219627|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219628|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219629|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
219630|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219631|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219632|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
219633|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219634|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219635|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
219636|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219637|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219638|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
219639|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219640|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219641|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
219642|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219643|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219644|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
219645|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219646|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219647|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
219648|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219649|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219650|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
219651|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219652|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219653|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
219654|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
219655|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
219656|NCT01309841|E3|Reported Event|Placebo|
219657|NCT01309841|E2|Reported Event|NKTR-118 25 mg|
219658|NCT01309841|E1|Reported Event|NKTR-118 12.5 mg|
219659|NCT01309828|B3|Baseline|Total|Total of all reporting groups
219660|NCT01309828|B2|Baseline|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
219661|NCT01309828|B1|Baseline|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
219662|NCT01309828|P2|Participant Flow|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
219663|NCT01309828|P1|Participant Flow|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
219664|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
219665|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
219666|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
219667|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
219668|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
219669|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
219670|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
219671|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
219672|NCT01309828|E2|Reported Event|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
219673|NCT01309828|E1|Reported Event|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
219674|NCT01309802|B3|Baseline|Total|Total of all reporting groups
219675|NCT01309802|B2|Baseline|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
219676|NCT01309802|B1|Baseline|Placebo|no intervention
219677|NCT01309802|P2|Participant Flow|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
219678|NCT01309802|P1|Participant Flow|Placebo|no intervention
219679|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
219680|NCT01309802|O1|Outcome|Placebo|no intervention
219715|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219716|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219681|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
219682|NCT01309802|O1|Outcome|Placebo|no intervention
219683|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
219684|NCT01309802|O1|Outcome|Placebo|no intervention
219685|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
219686|NCT01309802|O1|Outcome|Placebo|no intervention
219687|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
219688|NCT01309802|O1|Outcome|Placebo|no intervention
219689|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
219690|NCT01309802|O1|Outcome|Placebo|no intervention
219691|NCT01309802|E2|Reported Event|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
219692|NCT01309802|E1|Reported Event|Placebo|no intervention
219693|NCT01309737|B4|Baseline|Total|Total of all reporting groups
219694|NCT01309737|B3|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219695|NCT01309737|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219696|NCT01309737|B1|Baseline|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219697|NCT01309737|P5|Participant Flow|Placebo,CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219698|NCT01309737|P4|Participant Flow|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219699|NCT01309737|P3|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219700|NCT01309737|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219701|NCT01309737|P1|Participant Flow|CP-690,550 5mg|CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.
219702|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219703|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219704|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219705|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219706|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219707|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219708|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219709|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219710|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219711|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219712|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219713|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219714|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219717|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
221673|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
219718|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219719|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219720|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219721|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219722|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219723|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219724|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219725|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219726|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219727|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219728|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219729|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219730|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219731|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219732|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219733|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219734|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219735|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219736|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219737|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219738|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219739|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219740|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219741|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219742|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219743|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219744|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219745|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219746|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219747|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219748|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219749|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219750|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219751|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219752|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219753|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219754|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219755|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219756|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219757|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219758|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219759|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219760|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219847|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219761|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219762|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219763|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219764|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219765|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219766|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219767|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219768|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219769|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219770|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219771|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219772|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219773|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219774|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219775|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219776|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219777|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219778|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219779|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219780|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219781|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219782|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219783|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219784|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219785|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219786|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219787|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219788|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219789|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219790|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219791|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219792|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219793|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219794|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219795|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219796|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219797|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219798|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219799|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219800|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219801|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219802|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219803|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
220114|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
219804|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219805|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219806|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219807|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219808|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219809|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219810|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219811|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219812|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219813|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219814|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219815|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219816|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219817|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219818|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219819|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219820|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219821|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219822|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219823|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219824|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219825|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219826|NCT01309737|O2|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219827|NCT01309737|O1|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219828|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219829|NCT01309737|O3|Outcome|Placebo,CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219830|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219831|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219832|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219833|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219834|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219835|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219836|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219837|NCT01309737|O3|Outcome|Placebo,CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219838|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219839|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219840|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219841|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219842|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219843|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219844|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219845|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219846|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219848|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219849|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219850|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219851|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219852|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219853|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219854|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219855|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219856|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219857|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219858|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219859|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219860|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219861|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
219862|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
219863|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219864|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219865|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219866|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219867|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219868|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219869|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219870|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219871|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219872|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219873|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219874|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219875|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219876|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219877|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219878|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219879|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219880|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219881|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219882|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219883|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219884|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219885|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219886|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219887|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
219888|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219889|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
219890|NCT01309737|E5|Reported Event|Placebo|Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
219891|NCT01309737|E4|Reported Event|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.
219892|NCT01309737|E3|Reported Event|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.
219893|NCT01309737|E2|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
219894|NCT01309737|E1|Reported Event|CP-690,550 5mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Week 52.
219895|NCT01309672|B1|Baseline|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily
Prednisone, 5 mg, oral, 5 mg twice daily
abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
Prednisone: 5 mg, oral, 5 mg twice daily"
219896|NCT01309672|P1|Participant Flow|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily
Prednisone, 5 mg, oral, 5 mg twice daily
abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
Prednisone: 5 mg, oral, 5 mg twice daily"
219897|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
219898|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily
Prednisone, 5 mg, oral, 5 mg twice daily
abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
Prednisone: 5 mg, oral, 5 mg twice daily"
219899|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily
Prednisone, 5 mg, oral, 5 mg twice daily
abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
Prednisone: 5 mg, oral, 5 mg twice daily"
219900|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily
Prednisone, 5 mg, oral, 5 mg twice daily
abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
Prednisone: 5 mg, oral, 5 mg twice daily"
219901|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily
Prednisone, 5 mg, oral, 5 mg twice daily
abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
Prednisone: 5 mg, oral, 5 mg twice daily"
219902|NCT01309672|E1|Reported Event|Abiraterone Acetate + Prednisone|Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
219903|NCT01309659|B3|Baseline|Total|Total of all reporting groups
219904|NCT01309659|B2|Baseline|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219905|NCT01309659|B1|Baseline|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219906|NCT01309659|P2|Participant Flow|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219907|NCT01309659|P1|Participant Flow|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219908|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219909|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219910|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219911|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219912|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219913|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219914|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219915|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219916|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219917|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219918|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219919|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219920|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219921|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219922|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219923|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219924|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219925|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219926|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219927|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219928|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219929|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
220115|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
219930|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219931|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219932|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219933|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219934|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219935|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219936|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219937|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219938|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219939|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219940|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219941|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219942|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219943|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219944|NCT01309659|E2|Reported Event|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219945|NCT01309659|E1|Reported Event|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
219946|NCT01309646|B3|Baseline|Total|Total of all reporting groups
219947|NCT01309646|B2|Baseline|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219948|NCT01309646|B1|Baseline|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219949|NCT01309646|P2|Participant Flow|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219950|NCT01309646|P1|Participant Flow|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219951|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219952|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219953|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219954|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219955|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219956|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219957|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219958|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219959|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
220023|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
219960|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219961|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219962|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219963|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219964|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219965|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219966|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219967|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219968|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219969|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219970|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219971|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219972|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
220024|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
220116|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
219973|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219974|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219975|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219976|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219977|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219978|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219979|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219980|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219981|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219982|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219983|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219984|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219985|NCT01309646|E2|Reported Event|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
220025|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
219986|NCT01309646|E1|Reported Event|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
219987|NCT01309581|B3|Baseline|Total|Total of all reporting groups
219988|NCT01309581|B2|Baseline|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
219989|NCT01309581|B1|Baseline|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
219990|NCT01309581|P2|Participant Flow|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
219991|NCT01309581|P1|Participant Flow|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
219992|NCT01309581|O2|Outcome|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
219993|NCT01309581|O1|Outcome|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
219994|NCT01309581|O2|Outcome|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
219995|NCT01309581|O1|Outcome|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
219996|NCT01309581|E2|Reported Event|Methohexitol|
219997|NCT01309581|E1|Reported Event|Ketamine|
219998|NCT01309451|B3|Baseline|Total|Total of all reporting groups
219999|NCT01309451|B2|Baseline|Combine Group|Bevacizumab plus Ozurdex
220000|NCT01309451|B1|Baseline|Bevacizumab Alone|Bevacizumab only
220001|NCT01309451|P2|Participant Flow|Combined Group|bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
220002|NCT01309451|P1|Participant Flow|Bevacizumab Alone|monthly injection of bevacizumab intravitreally when retreatment criteria met
220003|NCT01309451|O2|Outcome|Combined Group|bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
220004|NCT01309451|O1|Outcome|Bevacizumab Alone|monthly injection of bevacizumab intravitreally when retreatment criteria met
220005|NCT01309451|O2|Outcome|Combined Group|"Bevacizumab plus Ozurdex
Bevacizumab: intravitreal, 1.25mg., monthly
dexamethasone intravitreal implant: 0.7mg, intravitreal every 4 months"
220006|NCT01309451|O1|Outcome|Bevacizumab Alone|Bevacizumab: intravitreal, 1.25mg., monthly
220007|NCT01309451|E2|Reported Event|Combined Group|bevacizumab 1.25mg intravitreally plus Ozurdex THIS GROUP ALSO INCLUDES PARTICIPANTS WHO HAD BOTH EYES IN THE STUDY (they received bevacizumab alone in one eye and bavacizumab + Ozurdex in the other.
220008|NCT01309451|E1|Reported Event|Bevacizumab Alone Group|bevacizumab 1.25mg intravitreally
220009|NCT01309386|B3|Baseline|Total|Total of all reporting groups
220010|NCT01309386|B2|Baseline|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
220011|NCT01309386|B1|Baseline|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
220012|NCT01309386|P2|Participant Flow|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
220013|NCT01309386|P1|Participant Flow|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
220014|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
220015|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
220016|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
220017|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
220018|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
220019|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
220020|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
220021|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
220022|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
220026|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
220027|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
220028|NCT01309386|E2|Reported Event|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
220029|NCT01309386|E1|Reported Event|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
220030|NCT01309360|B4|Baseline|Total|Total of all reporting groups
220031|NCT01309360|B3|Baseline|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
220032|NCT01309360|B2|Baseline|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
220033|NCT01309360|B1|Baseline|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
220034|NCT01309360|P3|Participant Flow|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
220035|NCT01309360|P2|Participant Flow|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
220036|NCT01309360|P1|Participant Flow|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
220037|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
220038|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
220039|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
220040|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
220041|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
220042|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
220043|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
220044|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
220045|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
220046|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
220047|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
220048|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
220049|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
220050|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
220051|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
220052|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
220053|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
220054|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
220055|NCT01309360|E3|Reported Event|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
220056|NCT01309360|E2|Reported Event|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
220057|NCT01309360|E1|Reported Event|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
220058|NCT01309308|B3|Baseline|Total|Total of all reporting groups
220059|NCT01309308|B2|Baseline|No Sweeping Group|The patients who did not have sweeping of the membranes
220060|NCT01309308|B1|Baseline|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
220061|NCT01309308|P2|Participant Flow|No Sweeping Group|The patients who did not have sweeping of the membranes
220062|NCT01309308|P1|Participant Flow|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
220063|NCT01309308|O2|Outcome|Not Swept|Patients whose membranes are not swept
220064|NCT01309308|O1|Outcome|Sweeping|In women who had completed 38 weeks of gestation sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with three circumferential passes of the examining fingers for only once.
220065|NCT01309308|O2|Outcome|Not Swept|Patients whose membranes are not swept
220066|NCT01309308|O1|Outcome|Sweeping|In women who had completed 38 weeks of gestation sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with three circumferential passes of the examining fingers for only once.
220067|NCT01309308|E2|Reported Event|No Sweeping Group|The patients who did not have sweeping of the membranes
220068|NCT01309308|E1|Reported Event|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
220069|NCT01309282|B1|Baseline|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220070|NCT01309282|P1|Participant Flow|Rituximab|Participants with sero-positive [Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (CCP+)] rheumatoid arthritis (RA), who had commenced therapy with rituximab (MabThera) following lack of response or intolerance to a single tumor necrosis factor (TNF)-inhibitor were included in this arm.
220106|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
221674|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
220071|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220072|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220073|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220074|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220075|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220076|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220077|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220078|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220079|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220080|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220081|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220082|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220083|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220084|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220085|NCT01309282|E1|Reported Event|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
220086|NCT01309269|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
220087|NCT01309269|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
220088|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
220089|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
220090|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
220091|NCT01309269|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
220092|NCT01309243|B3|Baseline|Total|Total of all reporting groups
220093|NCT01309243|B2|Baseline|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
220094|NCT01309243|B1|Baseline|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
220095|NCT01309243|P2|Participant Flow|EFV/FTC/TDF|Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
220096|NCT01309243|P1|Participant Flow|FTC/RPV/TDF|Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily
220097|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
220098|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
220099|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
220100|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
220101|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
220102|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
220103|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
220104|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
220105|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
220117|NCT01309243|E2|Reported Event|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
220118|NCT01309243|E1|Reported Event|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
220119|NCT01309204|B3|Baseline|Total|Total of all reporting groups
220120|NCT01309204|B2|Baseline|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
220121|NCT01309204|B1|Baseline|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
220122|NCT01309204|P2|Participant Flow|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
220123|NCT01309204|P1|Participant Flow|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
220124|NCT01309204|O2|Outcome|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
220125|NCT01309204|O1|Outcome|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
220126|NCT01309204|E2|Reported Event|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
220127|NCT01309204|E1|Reported Event|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
220128|NCT01309100|B1|Baseline|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
220129|NCT01309100|P1|Participant Flow|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
220130|NCT01309100|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens.
Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week."
220131|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).
Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
220132|NCT01309100|O2|Outcome|Acuvue Oasys Lens|"Johnson & Johnson Acuvue Oasys contact lens.
Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week."
220133|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).
Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
220134|NCT01309100|O2|Outcome|Acuvue Oasys Lens|"Johnson & Johnson Acuvue Oasys contact lens.
Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week."
220135|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).
Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
220136|NCT01309100|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens.
Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week."
220137|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens (RD2117-01).
Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
220138|NCT01309100|E1|Reported Event|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
220139|NCT01308918|B1|Baseline|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
220140|NCT01308918|P1|Participant Flow|GlideScope DLT Intubation With GlideRite DLT Stylet|The double lumen tube (DLT) is the technique of choice to obtain lung isolation. The GlideScope® (GLS, video laryngoscope allowing vizualisation of the airway and tube placement, has been used with a high level of success to assist positioning a single lumen tube (SLT) in normal situations and mainly in situations where the airway is considered or proven to be difficult.We have designed a new semi-rigid intubating stylet, the GlideRite DLT Stylet® (GR-DLT-S), which can be used for primary DLT intubation with the GLS. This pilot study was planned to observe the efficiency and the safety of the GR-DLT-S for primary insertion of DLT with the GLS in patients presenting a normal superior airway. After obtaining local IRB approval, 50 patients scheduled for thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy at l’Institut de cardiologie et de pneumologie de Québec, were enrolled in this observational study.
220213|NCT01308762|P3|Participant Flow|IMM-101 1.0 mg|Patients received an intradermal injection of IMM-101 1.0 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
220141|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
220142|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
220143|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
220144|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
220145|NCT01308918|E1|Reported Event|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
220146|NCT01308840|B1|Baseline|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
220147|NCT01308840|P1|Participant Flow|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
220148|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
220149|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
220150|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
220151|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
220152|NCT01308840|E1|Reported Event|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Panitumumab: Day 1 and 15 = 6 mg/kg IV
oxaliplatin: Days 1 and 15 = 85mg/m2 IV
gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
220153|NCT01308814|B3|Baseline|Total|Total of all reporting groups
220154|NCT01308814|B2|Baseline|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.
Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
220155|NCT01308814|B1|Baseline|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.
Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
220156|NCT01308814|P2|Participant Flow|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.
Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
220157|NCT01308814|P1|Participant Flow|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.
Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
220158|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.
Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
220159|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.
Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
220160|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.
Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
220161|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.
Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
220162|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.
Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
220370|NCT01308476|P1|Participant Flow|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
220163|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.
Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
220164|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.
Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
220165|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.
Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
220166|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.
Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
220167|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.
Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
220168|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.
Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
220169|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.
Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
220170|NCT01308814|O2|Outcome|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.
Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
220171|NCT01308814|O1|Outcome|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.
Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
220172|NCT01308814|E2|Reported Event|Estradiol|"Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.
Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered."
220173|NCT01308814|E1|Reported Event|Placebo|"Placebo patches for 12 months and placebo pills for 12 days every 2 months.
Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months."
220174|NCT01308788|B3|Baseline|Total|Total of all reporting groups
220175|NCT01308788|B2|Baseline|Aqueous Outflow|aqueous outflow treated
220176|NCT01308788|B1|Baseline|Aqueous Suppressant|aqueous suppressant treated
220177|NCT01308788|P2|Participant Flow|Aqueous Suppressant|aqueous suppressant treated
220178|NCT01308788|P1|Participant Flow|Aqueous Outflow|aqueous outflow treated
220179|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220180|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220181|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220182|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220183|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220184|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220185|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220186|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220187|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220188|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220189|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220190|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220191|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220192|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220193|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220194|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220195|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220196|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220197|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220198|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220199|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220200|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220201|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220202|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220203|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220204|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220205|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
220206|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
220207|NCT01308788|E2|Reported Event|Aqueous Suppressant|aqueous suppressant treated
220208|NCT01308788|E1|Reported Event|Aqueous Outflow|aqueous outflow treated
220209|NCT01308762|B4|Baseline|Total|Total of all reporting groups
220210|NCT01308762|B3|Baseline|Group 3|IMM-101 1.0 mg
220211|NCT01308762|B2|Baseline|Group 2|IMM-101 0.5 mg
220212|NCT01308762|B1|Baseline|Group 1|IMM-101 0.1 mg
220214|NCT01308762|P2|Participant Flow|IMM-101 0.5 mg|Patients received an intradermal injection of IMM-101 0.5 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
220215|NCT01308762|P1|Participant Flow|IMM-101 0.1 mg|Patients received an intradermal injection of IMM-101 0.1 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
220216|NCT01308762|O3|Outcome|Group 3|IMM-101 1.0 mg
220217|NCT01308762|O2|Outcome|Group 2|IMM-101 0.5 mg
220218|NCT01308762|O1|Outcome|Group 1|IMM-101 0.1 mg
220219|NCT01308762|O3|Outcome|IMM-101 1.0 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
220220|NCT01308762|O2|Outcome|IMM-101 0.5 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
220221|NCT01308762|O1|Outcome|IMM-101 0.1 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
220222|NCT01308762|E3|Reported Event|Group 3|IMM-101 1.0 mg
220223|NCT01308762|E2|Reported Event|Group 2|IMM-101 0.5 mg
220224|NCT01308762|E1|Reported Event|Group 1|IMM-101 0.1 mg
220225|NCT01308749|B3|Baseline|Total|Total of all reporting groups
220226|NCT01308749|B2|Baseline|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray
Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.
Subjects ages 3-10 years old will be titrated up to a maximum dose of 24 international units (IU). Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
220227|NCT01308749|B1|Baseline|Sequence 2:Placebo-oxytocin|"Intervention: Drug: placebo
Placebo: Placebo Nasal Spray"
220228|NCT01308749|P2|Participant Flow|jSequence 2: Placebo-oxytocin|8 weeks of of double blind placebo followed by 8 weeks of open-label oxytocin; this is the control group
220229|NCT01308749|P1|Participant Flow|Sequence 1: Oxytocin-oxytocin|8 weeks of double blind oxytocin followed by 8 weeks of open label oxytocin
220230|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|8 weeks of intervention following randomization
220231|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|8 weeks of Intervention following randomization
220232|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|8 weeks double blind placebo followed by 8 wks open label oxytocin
220233|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|8 weeks of Intervention following randomization
220234|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|Subjects who received 8 weeks of placebo treatment (baseline to week 8)
220235|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|8 weeks of Intervention: Drug: oxytocin (Syntocinon) baseline to week 8
220236|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|"Intervention: Drug: placebo
Placebo: Placebo Nasal Spray"
220237|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray
Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.
Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
220238|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|"Intervention: Drug: placebo
Placebo: Placebo Nasal Spray"
220239|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray
Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.
Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
220240|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|"Intervention: Drug: placebo
Placebo: Placebo Nasal Spray"
220241|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray
Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.
Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
220242|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|placebo x8 weeks then oxytocin x 8weeks
220243|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray
Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.
Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
220244|NCT01308749|O2|Outcome|Sequence 2: Placebo :Oxytocin|"Intervention: Drug: placebo
Placebo: Placebo Nasal Spray"
220245|NCT01308749|O1|Outcome|Sequence 1: Oxytocin-oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray
Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.
Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
220246|NCT01308749|O2|Outcome|Sequence 1: Oxytocin:Oxytocin|"Intervention: Drug: Syntocinon® Nasal Spray
Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.
Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
220247|NCT01308749|O1|Outcome|Sequence 2: Placebo:Oxytocin|"sequence2: placebo:oxytocin
Placebo: Placebo Nasal Spray"
220248|NCT01308749|O2|Outcome|Sequence 2: Oxytocin:Oxytocin|This accounts for all participants starting from baseline to week 16 who received oxytocin the whole time. All participants participants received oxytocin for the full 16 weeks.
220249|NCT01308749|O1|Outcome|Sequence 2: Placebo:Oxytocin|This is accounts for participants from week 0 to week 16. All participants first received placebo (week 0 to week 8) and then subsequently received oxytocin (week 8 to week 16)
220250|NCT01308749|O2|Outcome|Sequence 1: Oxytocin:Oxytocin|"Intervention: Drug: oxytocin = Syntocinon® Nasal Spray
total of 16 weeks exposure Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
220251|NCT01308749|O1|Outcome|Sequence 2: Placebo:Oxytocin|Intervention: Drug: placebo double blind for 8 weeks then oxytocin open label for 8 weeks
220252|NCT01308749|E4|Reported Event|Sequence 2: Placebo:Oxytocin Period 2|evaluates acute exposure to oxytocin in sequence 2 participants
220253|NCT01308749|E3|Reported Event|Sequence 1: Oxytocin:Oxytocin Period 2, Weeks 8-16|evaluates longer term adverse events with oxytocin
220254|NCT01308749|E2|Reported Event|Sequence 2: Placebo: Oxytocin Period 1 Weeks 0-8|"Intervention: Drug: placebo
Placebo: Placebo Nasal Spray"
220255|NCT01308749|E1|Reported Event|Sequence 1: Oxytocin:Oxytocin Period 1weeks 0-8|"Intervention: Drug: Syntocinon® Nasal Spray
Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.
Subjects ages 3-10 years old will be titrated up to a maximum dose of 24IU. Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
220256|NCT01308736|B3|Baseline|Total|Total of all reporting groups
220257|NCT01308736|B2|Baseline|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
220258|NCT01308736|B1|Baseline|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
220259|NCT01308736|P2|Participant Flow|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
220260|NCT01308736|P1|Participant Flow|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
220261|NCT01308736|O2|Outcome|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
220262|NCT01308736|O1|Outcome|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
220263|NCT01308736|E2|Reported Event|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
220264|NCT01308736|E1|Reported Event|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
220265|NCT01308619|B3|Baseline|Total|Total of all reporting groups
220266|NCT01308619|B2|Baseline|Placebo|placebo
220267|NCT01308619|B1|Baseline|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
220268|NCT01308619|P2|Participant Flow|Placebo Capsules|Placebo capsules for 12 weeks
220269|NCT01308619|P1|Participant Flow|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules for 12 weeks
220270|NCT01308619|O2|Outcome|Placebo|placebo
220271|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
220272|NCT01308619|O2|Outcome|Placebo|placebo
220273|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
220274|NCT01308619|O2|Outcome|Treatment Failure|
220275|NCT01308619|O1|Outcome|Treatment Success|
220276|NCT01308619|O2|Outcome|Placebo|placebo
220277|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
220278|NCT01308619|E2|Reported Event|Placebo|placebo
220279|NCT01308619|E1|Reported Event|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
220280|NCT01308580|B3|Baseline|Total|Total of all reporting groups
220281|NCT01308580|B2|Baseline|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220282|NCT01308580|B1|Baseline|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220283|NCT01308580|P2|Participant Flow|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220284|NCT01308580|P1|Participant Flow|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220285|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220337|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220286|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220287|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220288|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220289|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220290|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220291|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220292|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220293|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220294|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220295|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220296|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220297|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220298|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220299|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220300|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220301|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220302|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220303|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220304|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220305|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220306|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220307|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220308|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220309|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220310|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220311|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220312|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220313|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220314|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220315|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220316|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220317|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220318|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220319|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220320|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
220321|NCT01308580|E2|Reported Event|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant’s refusal of further study treatment or for a maximum of 10 cycles.
220322|NCT01308580|E1|Reported Event|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant’s refusal of further study treatment or for a maximum of 10 cycles.
220323|NCT01308567|B4|Baseline|Total|Total of all reporting groups
220324|NCT01308567|B3|Baseline|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220325|NCT01308567|B2|Baseline|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21–day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220326|NCT01308567|B1|Baseline|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220327|NCT01308567|P3|Participant Flow|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220328|NCT01308567|P2|Participant Flow|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21–day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220329|NCT01308567|P1|Participant Flow|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant’s refusal.
220330|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220331|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220332|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220333|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220334|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220335|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220336|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
221675|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
220338|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220339|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220340|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220341|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220342|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220343|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220344|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220345|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220346|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220347|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220348|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220349|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220350|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220351|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220352|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220353|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220354|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220355|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220356|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220357|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220358|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220359|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220360|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220361|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220362|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
220363|NCT01308567|E3|Reported Event|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
220364|NCT01308567|E2|Reported Event|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
220365|NCT01308567|E1|Reported Event|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
220366|NCT01308476|B3|Baseline|Total|Total of all reporting groups
220367|NCT01308476|B2|Baseline|Control Group|Control group with same medication but not receiving reminder SMS.
220368|NCT01308476|B1|Baseline|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
220369|NCT01308476|P2|Participant Flow|Control Group|Control group with same medication but not receiving reminder SMS.
221676|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
220371|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
220372|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
220373|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
220374|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
220375|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
220376|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
220377|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
220378|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
220379|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
220380|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
220381|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
220382|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
220383|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
220384|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
220385|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
220386|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
220387|NCT01308476|E2|Reported Event|Control Group|Control group with same medication but not receiving reminder SMS.
220388|NCT01308476|E1|Reported Event|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
220389|NCT01308463|B1|Baseline|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
220390|NCT01308463|P1|Participant Flow|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
220391|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
220392|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
220393|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
220394|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
220395|NCT01308463|E1|Reported Event|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
220396|NCT01308450|B1|Baseline|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
220397|NCT01308450|P1|Participant Flow|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
220398|NCT01308450|O1|Outcome|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
220399|NCT01308450|E1|Reported Event|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
220400|NCT01308424|B3|Baseline|Total|Total of all reporting groups
220401|NCT01308424|B2|Baseline|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
220402|NCT01308424|B1|Baseline|Matching Placebo|Matching placebo : sublingual dosing for 7 days
220403|NCT01308424|P3|Participant Flow|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
220404|NCT01308424|P2|Participant Flow|Matching Placebo|Matching placebo : sublingual dosing for 7 days
220405|NCT01308424|P1|Participant Flow|Baseline Run In|Baseline period to assess eligibility before randomization
220406|NCT01308424|O2|Outcome|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
220407|NCT01308424|O1|Outcome|Matching Placebo|Matching placebo : sublingual dosing for 7 days
220408|NCT01308424|E3|Reported Event|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
220409|NCT01308424|E2|Reported Event|Matching Placebo|Matching placebo : sublingual dosing for 7 days
220410|NCT01308424|E1|Reported Event|Baseline Run In|Baseline period to assess eligibility before randomization
220411|NCT01307787|B3|Baseline|Total|Total of all reporting groups
220412|NCT01307787|B2|Baseline|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
220437|NCT01307618|P2|Participant Flow|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
Recombinant Interleukin-12: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
221677|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
220413|NCT01307787|B1|Baseline|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.
The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
220414|NCT01307787|P2|Participant Flow|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
220415|NCT01307787|P1|Participant Flow|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.
The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
220416|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
220417|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
220418|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
220419|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
220420|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
220421|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
220422|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
220423|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
220424|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
220425|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
220426|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
220427|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
220428|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention. WLC was allowed to follow the program after the study.
220429|NCT01307787|O1|Outcome|Intervention Fit Program|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
220430|NCT01307787|O2|Outcome|Waiting List Control Group|No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
220431|NCT01307787|O1|Outcome|Intervention Fit Program|An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
220432|NCT01307787|E2|Reported Event|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
220433|NCT01307787|E1|Reported Event|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.
The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
220434|NCT01307618|B3|Baseline|Total|Total of all reporting groups
220435|NCT01307618|B2|Baseline|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
Recombinant Interleukin-12: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220436|NCT01307618|B1|Baseline|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
MART-1 Antigen: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220504|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
221678|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
220438|NCT01307618|P1|Participant Flow|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
MART-1 Antigen: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220439|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
Recombinant Interleukin-12: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220440|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
MART-1 Antigen: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220441|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
Recombinant Interleukin-12: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220442|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
MART-1 Antigen: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220443|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
Recombinant Interleukin-12: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220444|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
MART-1 Antigen: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220445|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
Recombinant Interleukin-12: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220446|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
MART-1 Antigen: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220447|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
Recombinant Interleukin-12: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220448|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
MART-1 Antigen: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220449|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
Recombinant Interleukin-12: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220450|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
MART-1 Antigen: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220451|NCT01307618|E2|Reported Event|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
Recombinant Interleukin-12: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220452|NCT01307618|E1|Reported Event|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.
NA17.A2 Peptide Vaccine: Given SC or ID
Recombinant MAGE-3.1 Antigen: Given SC or ID
MART-1 Antigen: Given SC or ID
Laboratory Biomarker Analysis: Correlative studies"
220453|NCT01307423|B4|Baseline|Total|Total of all reporting groups
220454|NCT01307423|B3|Baseline|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
220455|NCT01307423|B2|Baseline|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
220456|NCT01307423|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220457|NCT01307423|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
220458|NCT01307423|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
220459|NCT01307423|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years
220460|NCT01307423|P4|Participant Flow|Placebo/ 20mg Apremilast EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
220461|NCT01307423|P3|Participant Flow|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
221679|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
220462|NCT01307423|P2|Participant Flow|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
220463|NCT01307423|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
220464|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220465|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220466|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220467|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220468|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220469|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220470|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220471|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220472|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220473|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220474|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220475|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220476|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220477|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220478|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220479|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220480|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220481|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220482|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220483|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220484|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220485|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220486|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220487|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220488|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220489|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220490|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220491|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220492|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220493|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220494|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220495|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220496|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220497|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220498|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220499|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220500|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220501|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220502|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220503|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220505|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220506|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220507|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220508|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220509|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220510|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220511|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220512|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220513|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220514|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220515|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220516|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220517|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220518|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220519|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220520|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220521|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220522|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220523|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220524|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220525|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220526|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220527|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220528|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220529|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220530|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220531|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220532|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220533|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220534|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220535|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220536|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220537|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220538|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220539|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220540|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220541|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220542|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220543|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220544|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220545|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220546|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220547|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220548|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220549|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220550|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220551|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220552|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220553|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220554|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
220555|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
220556|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220557|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
220558|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
220559|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
220560|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
220561|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
220562|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220563|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
220564|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
220565|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
220566|NCT01307423|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
220567|NCT01307423|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
220568|NCT01307423|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
220569|NCT01307423|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
220570|NCT01307423|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
220571|NCT01307319|B4|Baseline|Total|Total of all reporting groups
220572|NCT01307319|B3|Baseline|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
220573|NCT01307319|B2|Baseline|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
220574|NCT01307319|B1|Baseline|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
220575|NCT01307319|P3|Participant Flow|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
220576|NCT01307319|P2|Participant Flow|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
220577|NCT01307319|P1|Participant Flow|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
220578|NCT01307319|O3|Outcome|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
220579|NCT01307319|O2|Outcome|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
220580|NCT01307319|O1|Outcome|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
220581|NCT01307319|O3|Outcome|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
220582|NCT01307319|O2|Outcome|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
220583|NCT01307319|O1|Outcome|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
220584|NCT01307319|E3|Reported Event|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
220585|NCT01307319|E2|Reported Event|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
220586|NCT01307319|E1|Reported Event|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
220587|NCT01307111|B4|Baseline|Total|Total of all reporting groups
220588|NCT01307111|B3|Baseline|Not Randomized|Women not eligible to continue to randomization.
220589|NCT01307111|B2|Baseline|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
220590|NCT01307111|B1|Baseline|Misoprostol|Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.
221680|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
220591|NCT01307111|P2|Participant Flow|Placebo|"Pills which are identical to the study drug in appearance, taste, and smell.
Placebo: Pills which are identical to the study drug in appearance, taste, and smell."
220592|NCT01307111|P1|Participant Flow|Misoprostol|"Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.
Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion."
220593|NCT01307111|O2|Outcome|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
220594|NCT01307111|O1|Outcome|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
220595|NCT01307111|O2|Outcome|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
220596|NCT01307111|O1|Outcome|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
220597|NCT01307111|E2|Reported Event|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
220598|NCT01307111|E1|Reported Event|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
220599|NCT01307046|B3|Baseline|Total|Total of all reporting groups
220600|NCT01307046|B2|Baseline|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
220601|NCT01307046|B1|Baseline|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
220602|NCT01307046|P2|Participant Flow|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
220603|NCT01307046|P1|Participant Flow|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
220604|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
220605|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
220606|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
220607|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
220608|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
220609|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
220610|NCT01307046|E2|Reported Event|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
220611|NCT01307046|E1|Reported Event|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
220612|NCT01307033|B3|Baseline|Total|Total of all reporting groups
220613|NCT01307033|B2|Baseline|MK-0954A (L100/H12.5)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension.
220614|NCT01307033|B1|Baseline|MK-0954H (L50/H12.5)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
220615|NCT01307033|P4|Participant Flow|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
220616|NCT01307033|P3|Participant Flow|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
220617|NCT01307033|P2|Participant Flow|MK-0954A (L100/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
220618|NCT01307033|P1|Participant Flow|MK-0954H (L50/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
220619|NCT01307033|O2|Outcome|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
220620|NCT01307033|O1|Outcome|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
220621|NCT01307033|O2|Outcome|MK-0954A (L100/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
220622|NCT01307033|O1|Outcome|MK-0954H (L50/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
220623|NCT01307033|O2|Outcome|MK-0954A (L100/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5).
220624|NCT01307033|O1|Outcome|MK-0954H (L50/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5).
220625|NCT01307033|E4|Reported Event|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
220683|NCT01307020|E7|Reported Event|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
221681|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
220626|NCT01307033|E3|Reported Event|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
220627|NCT01307033|E2|Reported Event|MK-0954A (L100/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
220628|NCT01307033|E1|Reported Event|MK-0954H (L50/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
220629|NCT01307020|B11|Baseline|Total|Total of all reporting groups
220630|NCT01307020|B10|Baseline|Placebo|Placebo oral film-coated tablet, once
220631|NCT01307020|B9|Baseline|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
220632|NCT01307020|B8|Baseline|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
220633|NCT01307020|B7|Baseline|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
220634|NCT01307020|B6|Baseline|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
220635|NCT01307020|B5|Baseline|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
220636|NCT01307020|B4|Baseline|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
220637|NCT01307020|B3|Baseline|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220638|NCT01307020|B2|Baseline|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
220639|NCT01307020|B1|Baseline|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220640|NCT01307020|P10|Participant Flow|Placebo|Placebo oral film-coated tablet, once
220641|NCT01307020|P9|Participant Flow|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
220642|NCT01307020|P8|Participant Flow|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
220643|NCT01307020|P7|Participant Flow|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
220644|NCT01307020|P6|Participant Flow|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
220645|NCT01307020|P5|Participant Flow|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
220646|NCT01307020|P4|Participant Flow|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
220647|NCT01307020|P3|Participant Flow|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220648|NCT01307020|P2|Participant Flow|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
220649|NCT01307020|P1|Participant Flow|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220650|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
220651|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
220652|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
220653|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
220654|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
220655|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
220656|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
220657|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220658|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
220659|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220660|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
220661|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
220662|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
220663|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
220664|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
220665|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
220666|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
220667|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220668|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
220669|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220670|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
220671|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
220672|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
220673|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
220674|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
220675|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
220676|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
220677|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220678|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
220679|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220680|NCT01307020|E10|Reported Event|Placebo|Placebo oral film-coated tablet, once
220681|NCT01307020|E9|Reported Event|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
220682|NCT01307020|E8|Reported Event|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
221682|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
220686|NCT01307020|E4|Reported Event|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
220687|NCT01307020|E3|Reported Event|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220688|NCT01307020|E2|Reported Event|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
220689|NCT01307020|E1|Reported Event|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
220690|NCT01307007|B3|Baseline|Total|Total of all reporting groups
220691|NCT01307007|B2|Baseline|Iron Dextran Injection|Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
220692|NCT01307007|B1|Baseline|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
220693|NCT01307007|P2|Participant Flow|Iron Dextran Injection|Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
220694|NCT01307007|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
220695|NCT01307007|O2|Outcome|Iron Dextran Injection|Iron Dextran Injection: Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
220696|NCT01307007|O1|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM): 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
220697|NCT01307007|E2|Reported Event|Iron Dextran Injection|Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
220698|NCT01307007|E1|Reported Event|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
220699|NCT01306968|B5|Baseline|Total|Total of all reporting groups
220700|NCT01306968|B4|Baseline|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)
sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
220701|NCT01306968|B3|Baseline|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday
hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.
The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
220702|NCT01306968|B2|Baseline|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
220703|NCT01306968|B1|Baseline|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
220704|NCT01306968|P4|Participant Flow|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)
sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
220705|NCT01306968|P3|Participant Flow|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday
hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.
The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
220706|NCT01306968|P2|Participant Flow|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
220707|NCT01306968|P1|Participant Flow|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
220708|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)
sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
220764|NCT01306617|P1|Participant Flow|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
221683|NCT01303224|E4|Reported Event|Placebo|oral tablet, once daily
220709|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday
hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.
The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
220710|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
220711|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
220712|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)
sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
220713|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday
hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.
The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
220714|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
220715|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
220716|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)
sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
220717|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday
hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.
The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
220718|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD) Follow-up visit 2 = Day 56 (up to day 100)
220719|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
220720|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)
sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
220721|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday. Each subject will complete 40 sessions.
The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
220722|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
220723|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
220724|NCT01306968|E4|Reported Event|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)
sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
220765|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220766|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220767|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220725|NCT01306968|E3|Reported Event|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday
hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.
The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
220726|NCT01306968|E2|Reported Event|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
220727|NCT01306968|E1|Reported Event|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
220728|NCT01306877|B3|Baseline|Total|Total of all reporting groups
220729|NCT01306877|B2|Baseline|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
220730|NCT01306877|B1|Baseline|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
220731|NCT01306877|P2|Participant Flow|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set : Surgical device
220732|NCT01306877|P1|Participant Flow|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set : Surgical device
220733|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
220734|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
220735|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
220736|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
220737|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
220738|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
220739|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
220740|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
220741|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
220742|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
220743|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
220744|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
220745|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
220746|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
220747|NCT01306877|E2|Reported Event|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
220748|NCT01306877|E1|Reported Event|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
220749|NCT01306643|B1|Baseline|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
220750|NCT01306643|P1|Participant Flow|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
220751|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
220752|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
220753|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
220754|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
220755|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
220756|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
220757|NCT01306643|E1|Reported Event|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
220758|NCT01306617|B4|Baseline|Total|Total of all reporting groups
220759|NCT01306617|B3|Baseline|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220760|NCT01306617|B2|Baseline|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220761|NCT01306617|B1|Baseline|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220762|NCT01306617|P3|Participant Flow|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220763|NCT01306617|P2|Participant Flow|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220830|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
220768|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220769|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220770|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220771|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220772|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220773|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220774|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220775|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220776|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220777|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220778|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220779|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220780|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220781|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220782|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220783|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220784|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220785|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220786|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220787|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220788|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220789|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220790|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220791|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220792|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220793|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220874|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
220794|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220795|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220796|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220797|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220798|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220799|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220800|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220801|NCT01306617|E3|Reported Event|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
220802|NCT01306617|E2|Reported Event|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naive|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220803|NCT01306617|E1|Reported Event|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naive|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
220804|NCT01306305|B3|Baseline|Total|Total of all reporting groups
220805|NCT01306305|B2|Baseline|Elderly|Elderly subjects aged over 60 years
220806|NCT01306305|B1|Baseline|Adults|Adults from 18 to 60 years old inclusive
220807|NCT01306305|P2|Participant Flow|Elderly|Elderly subjects aged over 60 years
220808|NCT01306305|P1|Participant Flow|Adults|Adults from 18 to 60 years old inclusive
220809|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
220810|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
220811|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
220812|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
220813|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
220814|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
220815|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
220816|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
220817|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
220818|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
220819|NCT01306305|E2|Reported Event|Elderly|Elderly subjects aged over 60 years
220820|NCT01306305|E1|Reported Event|Adults|Adults from 18 to 60 years old inclusive
220821|NCT01306292|B3|Baseline|Total|Total of all reporting groups
220822|NCT01306292|B2|Baseline|Normal Group|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.
220823|NCT01306292|B1|Baseline|Hypertension Group|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.
220824|NCT01306292|P4|Participant Flow|Normal Group (Placebo First, Then SonoVue)|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
220825|NCT01306292|P3|Participant Flow|Normal Group (SonoVue First, Then Placebo)|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
220826|NCT01306292|P2|Participant Flow|Hypertension Group (Placebo First, Then SonoVue)|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
220827|NCT01306292|P1|Participant Flow|Hypertension Group (SonoVue First, Then Placebo)|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
220828|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
220829|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
220998|NCT01305811|B2|Baseline|Wait List|Wait list for 2 months then weekly acupuncture for four months
220831|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
220832|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
220833|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
220834|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
220835|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
220836|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
220837|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
220838|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
220839|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
220840|NCT01306292|E2|Reported Event|Normal Pulmonary Pressure Group|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.
220841|NCT01306292|E1|Reported Event|Hypertension Group|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.
220842|NCT01306253|B3|Baseline|Total|Total of all reporting groups
220843|NCT01306253|B2|Baseline|Elderly|Elderly subjects aged over 60 years
220844|NCT01306253|B1|Baseline|Adults|Adults from 18 to 60 years old inclusive
220845|NCT01306253|P2|Participant Flow|Elderly|Elderly subjects aged over 60 years
220846|NCT01306253|P1|Participant Flow|Adults|Adults from 18 to 60 years old inclusive
220847|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
220848|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
220849|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
220850|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
220851|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
220852|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
220853|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
220854|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
220855|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
220856|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
220857|NCT01306253|E2|Reported Event|Elderly|Elderly subjects aged over 60 years
220858|NCT01306253|E1|Reported Event|Adults|Adults from 18 to 60 years old inclusive
220859|NCT01306214|B4|Baseline|Total|Total of all reporting groups
220860|NCT01306214|B3|Baseline|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
220861|NCT01306214|B2|Baseline|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
220862|NCT01306214|B1|Baseline|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
220863|NCT01306214|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
220864|NCT01306214|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
220865|NCT01306214|P1|Participant Flow|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
220866|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
220867|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
220868|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
220869|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
220870|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
220871|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
220872|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
220873|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
220875|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
220876|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
220877|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
220878|NCT01306214|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
220879|NCT01306214|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
220880|NCT01306214|E1|Reported Event|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
220881|NCT01306201|B1|Baseline|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
220882|NCT01306201|P1|Participant Flow|Respiration Rate in GCF Patients|In-patients from the hospital general care floor, who choose to participate in the study. Participants were monitored for 30 minute periods to collect respiratory rate information from non-invasive sensors.
220883|NCT01306201|O1|Outcome|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
220884|NCT01306201|O1|Outcome|Overall Study Population|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide derived respiration rates were recorded on all the volunteers simultaneously.
220885|NCT01306201|O3|Outcome|Respiration Rate From Transthoracic Impedance|Respiration Rate derived from Transthoracic Impedance
220886|NCT01306201|O2|Outcome|Respiration Rate From Endtidal Carbon Dioxide Waveform|Respiration rate determined by manual overscoring of capnography waveforms
220887|NCT01306201|O1|Outcome|Respiration Rate From Covidien Respiration Rate Software|Respiration rate determined by novel plethysmographic analysis
220888|NCT01306201|E1|Reported Event|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
220889|NCT01306175|B1|Baseline|Study Total|"This was a randomised, two-period, cross-over trial, the two treatments administered were
A single dose of digoxin 0.5 mg on day 1
Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5
Between treatment periods there was a washout period of at least 14 days."
220890|NCT01306175|P1|Participant Flow|Study Total|"This was a randomised, two-period cross-over trial, the two treatments administered were
A single dose of 0.5mg digoxin on day 1
empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5
Between treatment periods there was a washout period of at least 14 days."
220891|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
220892|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
220893|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
220894|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
220895|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
220896|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
220897|NCT01306175|E2|Reported Event|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
220898|NCT01306175|E1|Reported Event|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
220899|NCT01306162|B5|Baseline|Total|Total of all reporting groups
220900|NCT01306162|B4|Baseline|TrtC -- TrtE -- TrtD -- TrtA|Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg (Trt. A)
220901|NCT01306162|B3|Baseline|TrtB -- TrtD -- TrtE -- TrtA|Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg (Trt. A)
220902|NCT01306162|B2|Baseline|TrtA -- TrtC -- TrtE -- TrtD|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D)
220903|NCT01306162|B1|Baseline|TrtA -- TrtB -- TrtD -- TrtE|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E)
220904|NCT01306162|P4|Participant Flow|TrtC -- TrtE -- TrtD -- TrtA|Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg (Trt. A)
220905|NCT01306162|P3|Participant Flow|TrtB -- TrtD -- TrtE -- TrtA|Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg (Trt. A)
220906|NCT01306162|P2|Participant Flow|TrtA -- TrtC -- TrtE -- TrtD|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D)
220907|NCT01306162|P1|Participant Flow|TrtA -- TrtB -- TrtD -- TrtE|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E)
220908|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
220909|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
220910|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
220911|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
220912|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
220913|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
220914|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
220915|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
220916|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
220917|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
220918|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
220919|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
220920|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
220921|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
220922|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
220923|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
220924|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
220925|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
220926|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
220927|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
220928|NCT01306162|E6|Reported Event|400mg DR + 400mg DR Bid 2h Later (TrtE2)|Dronedarone 400mg + Dronedarone 400mg bid given 2h later
220929|NCT01306162|E5|Reported Event|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
220930|NCT01306162|E4|Reported Event|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
220931|NCT01306162|E3|Reported Event|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
220932|NCT01306162|E2|Reported Event|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
220933|NCT01306162|E1|Reported Event|150mg DE (TrtA)|Dabigatran 150mg
220934|NCT01306032|B7|Baseline|Total|Total of all reporting groups
220935|NCT01306032|B6|Baseline|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220936|NCT01306032|B5|Baseline|Non-Hodgkin’s: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
220937|NCT01306032|B4|Baseline|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220938|NCT01306032|B3|Baseline|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
220939|NCT01306032|B2|Baseline|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220940|NCT01306032|B1|Baseline|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
220941|NCT01306032|P6|Participant Flow|Non-Hodgkin's: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
220942|NCT01306032|P5|Participant Flow|Non-Hodgkin's: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220943|NCT01306032|P4|Participant Flow|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
220944|NCT01306032|P3|Participant Flow|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220945|NCT01306032|P2|Participant Flow|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
220946|NCT01306032|P1|Participant Flow|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220947|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220948|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220949|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220950|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220951|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
220952|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220953|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220954|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220955|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220956|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
221056|NCT01305564|B1|Baseline|Baseline Characteristics|All treated with Denali filter.
220957|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220958|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220959|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
220960|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220961|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220962|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220963|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220964|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220965|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220966|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220967|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
220968|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220969|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220970|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220971|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220972|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220973|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220974|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220975|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
220976|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220977|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220978|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220979|NCT01306032|O4|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220980|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220981|NCT01306032|O2|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220982|NCT01306032|O1|Outcome|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220983|NCT01306032|O6|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220984|NCT01306032|O5|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220985|NCT01306032|O4|Outcome|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220986|NCT01306032|O3|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220987|NCT01306032|O2|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220988|NCT01306032|O1|Outcome|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220989|NCT01306032|E8|Reported Event|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220990|NCT01306032|E7|Reported Event|Non-Hodgkin’s: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220991|NCT01306032|E6|Reported Event|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220992|NCT01306032|E5|Reported Event|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220993|NCT01306032|E4|Reported Event|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220994|NCT01306032|E3|Reported Event|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220995|NCT01306032|E2|Reported Event|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
220996|NCT01306032|E1|Reported Event|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
220997|NCT01305811|B3|Baseline|Total|Total of all reporting groups
220999|NCT01305811|B1|Baseline|Bi-weekly Acupuncture Treatment|Bi-weekly acupuncture treatment for 6 months
221000|NCT01305811|P2|Participant Flow|Wait List|Veterans with diagnosed symptoms of Gulf War Illness were randomized to 2 months of waitlist followed by weekly acupuncture treatments for 4 months.
221001|NCT01305811|P1|Participant Flow|Bi-weekly Acupuncture Treatment|Veterans with diagnosed symptoms of Gulf War Illness were randomized to six months of biweekly acupuncture treatments.
221002|NCT01305811|O2|Outcome|Wait List|"Wait list for 2 months.
Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners."
221003|NCT01305811|O1|Outcome|Bi-weekly Acupuncture Treatment|"Bi-weekly acupuncture treatment
Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners."
221004|NCT01305811|O2|Outcome|Wait List Then Weekly Acupuncture|group mean SF-36 P score at 6 months
221005|NCT01305811|O1|Outcome|Bi-Weekly Acupuncture|group mean SF-36 P score at 6 months
221006|NCT01305811|E2|Reported Event|Wait List|"Wait list for 2 months followed by 4 months of weekly acupuncture
No Adverse events were reported in the Wait list group"
221007|NCT01305811|E1|Reported Event|Bi-Weekly Acupuncture|"Bi-Weekly Acupuncture for 6 months
1 serious unexpected adverse event in the biweekly group: Subject’s practitioner was told by subject of a suicide attempt. Case was reviewed and the medical monitor and identified as needing follow up. Subject was hospitalized for observation, released to his daughter’s custody. Both the VA and the Crisis Center were in touch with him on Feb 27th and are making arrangements to take him, (patient reported), either in patient or into a program. He had a follow-up appointment Feb 28th at the VA and he was hospitalized at this time and is currently hospitalized.
The practitioner will also follow up with subject’s PCP."
221008|NCT01305772|B3|Baseline|Total|Total of all reporting groups
221009|NCT01305772|B2|Baseline|Surgery|Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration
221010|NCT01305772|B1|Baseline|Radiation Therapy|Patients who underwent radiation therapy only, in conjunction with panitumumab therapy
221011|NCT01305772|P2|Participant Flow|Surgery|"Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration
Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 & 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 & 4 during RT.
Surgery : Second biopsy was taken from surgical resection tissue (when possible obtained pre and post panitumumab biopsies from the same site)."
221012|NCT01305772|P1|Participant Flow|Radiation Therapy|"Patients who underwent radiation therapy only, in conjunction with panitumumab therapy.
Radiation Therapy : Radiation therapy was initiated within 8 weeks after surgery, or as soon as possible.
Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 & 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 & 4 during RT."
221013|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
221014|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
221015|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
221016|NCT01305772|E2|Reported Event|Surgery|Surgery after research PET/CT scans and subsequent radiation therapy with panitumumab therapy.
221017|NCT01305772|E1|Reported Event|Radiation Therapy|Radiation therapy with panitumumab therapy.
221018|NCT01305655|B1|Baseline|Glucarpidase Arm|"In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.
Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values."
221019|NCT01305655|P1|Participant Flow|Glucarpidase Arm|In children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
221020|NCT01305655|O1|Outcome|Glucarpidase Arm|47 children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
221021|NCT01305655|E1|Reported Event|Glucarpidase Arm|"In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.
Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.
No serious effect reported."
221022|NCT01305577|B4|Baseline|Total|Total of all reporting groups
221023|NCT01305577|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221024|NCT01305577|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221025|NCT01305577|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221026|NCT01305577|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221273|NCT01304693|E2|Reported Event|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
221027|NCT01305577|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221028|NCT01305577|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221029|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221030|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221031|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221032|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221033|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221034|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221035|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221036|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221037|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221038|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221039|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221040|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221041|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221042|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221043|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221044|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221045|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221046|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221047|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221048|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221049|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221050|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221051|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221052|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221053|NCT01305577|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221054|NCT01305577|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221055|NCT01305577|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
221057|NCT01305564|P1|Participant Flow|Denali Inferior Vena Cava Filter|"All subjects enrolled will receive the Denali vena cava filter.
Denali inferior vena cava filter: The Denali inferior vena cava filter is a mechanical filtration device consisting of two levels of filtration (upper arms, lower legs), a retrieval hook to allow for retrieval using a standard snare, cranial and caudal anchors, and penetration limiters. The Denali filter is made from a laser cut nitinol tube."
221058|NCT01305564|O1|Outcome|Filter Penetration at Retrieval|
221059|NCT01305564|O1|Outcome|Filter Penetration at Placement|
221060|NCT01305564|O1|Outcome|Filter Tilt|At Retrieval
221061|NCT01305564|O1|Outcome|Filter Tilt|At Implant
221062|NCT01305564|O1|Outcome|Filter Migration >2 cm|
221063|NCT01305564|O1|Outcome|Filter Fracture|
221064|NCT01305564|O1|Outcome|New or Worsening DVT|
221065|NCT01305564|O1|Outcome|Recurrent PE|
221066|NCT01305564|O1|Outcome|Clinical Success of Retrieval|
221067|NCT01305564|O1|Outcome|Technical Success of Retrieval|
221068|NCT01305564|O1|Outcome|Clinical Success of Placement|
221069|NCT01305564|O1|Outcome|Technical Success of Placement|Primary implant endpoint
221070|NCT01305564|E1|Reported Event|Serious Adverse Events|"Serious Adverse Events are reported for all 200 subjects and all serious events are reported.
Non-serious adverse events are reported when the reported threshold for an event is at 5% or higher. This represents 175 subjects and not 200 for non-serious events."
221071|NCT01305473|B1|Baseline|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
221072|NCT01305473|P1|Participant Flow|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
221073|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
221074|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
221075|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
221076|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
221077|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
221078|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
221079|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
221080|NCT01305473|E1|Reported Event|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
221081|NCT01305408|B3|Baseline|Total|Total of all reporting groups
221082|NCT01305408|B2|Baseline|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221083|NCT01305408|B1|Baseline|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221084|NCT01305408|P2|Participant Flow|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221085|NCT01305408|P1|Participant Flow|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221086|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221087|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221088|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221089|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221090|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221091|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221092|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221093|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221094|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221095|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221096|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221274|NCT01304693|E1|Reported Event|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
221097|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221098|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221099|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221100|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221101|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221102|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221103|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221104|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221105|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221106|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221107|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221108|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221109|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221110|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221111|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221112|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221113|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221114|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221115|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221116|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221117|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221118|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221119|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221120|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221121|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221122|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221123|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221124|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221125|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221126|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221127|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221128|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221275|NCT01304641|B3|Baseline|Total|Total of all reporting groups
221129|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221130|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221131|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221132|NCT01305408|E2|Reported Event|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
221133|NCT01305408|E1|Reported Event|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
221134|NCT01305265|B3|Baseline|Total|Total of all reporting groups
221135|NCT01305265|B2|Baseline|Intervention Group|Endotracheal tube cuff inflated using the inflate & palpate technique. The cuff pressure then was adjusted to 22-26cmH2O within 15min after endotracheal intubation by trained study staff.
221136|NCT01305265|B1|Baseline|Control Group|Endotracheal tube cuff inflated using the inflate & palpate technique
221137|NCT01305265|P2|Participant Flow|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
221138|NCT01305265|P1|Participant Flow|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
221139|NCT01305265|O2|Outcome|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
221140|NCT01305265|O1|Outcome|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
221141|NCT01305265|E2|Reported Event|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
221142|NCT01305265|E1|Reported Event|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
221143|NCT01305252|B3|Baseline|Total|Total of all reporting groups
221144|NCT01305252|B2|Baseline|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.
tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221145|NCT01305252|B1|Baseline|Tadalafil Alone|"tadalafil 40mg QD
tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221146|NCT01305252|P2|Participant Flow|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.
tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221147|NCT01305252|P1|Participant Flow|Tadalafil Alone|"tadalafil 40mg QD
tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221148|NCT01305252|O2|Outcome|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.
tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221149|NCT01305252|O1|Outcome|Tadalafil Alone|"tadalafil 40mg QD
tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221150|NCT01305252|O2|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.
Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221151|NCT01305252|O1|Outcome|Tadalafil Alone|"Tadalafil 40mg QD
Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221152|NCT01305252|O2|Outcome|Tadalafil Alone|"Tadalafil 40mg QD
Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221153|NCT01305252|O1|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.
Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221154|NCT01305252|O2|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.
Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221155|NCT01305252|O1|Outcome|Tadalafil Alone|"Tadalafil 40mg QD
Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221156|NCT01305252|O2|Outcome|Tadalafil Alone|"Tadalafil 40mg QD
Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221157|NCT01305252|O1|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.
Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221158|NCT01305252|E2|Reported Event|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.
tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221159|NCT01305252|E1|Reported Event|Tadalafil Alone|"tadalafil 40mg QD
tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
221160|NCT01305239|B1|Baseline|Exemestane|25 mg oral tablet once a day
221161|NCT01305239|P1|Participant Flow|Exemestane|25 mg oral tablet once a day
221162|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
221163|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
221164|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
221165|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
221166|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
221167|NCT01305239|E1|Reported Event|Exemestane|25 mg oral tablet once a day
221168|NCT01305213|B3|Baseline|Total|Total of all reporting groups
221169|NCT01305213|B2|Baseline|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
221170|NCT01305213|B1|Baseline|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
221171|NCT01305213|P2|Participant Flow|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
221172|NCT01305213|P1|Participant Flow|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
221173|NCT01305213|O2|Outcome|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
221174|NCT01305213|O1|Outcome|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
221175|NCT01305213|O2|Outcome|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
221176|NCT01305213|O1|Outcome|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
221177|NCT01305213|E2|Reported Event|Arm II Bevacizumab + Fosbretabulin|Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
221178|NCT01305213|E1|Reported Event|Arm I Bevacizumab|Bevacizumab 15mg/kg IV Day 1 every 3 weeks
221179|NCT01305200|B4|Baseline|Total|Total of all reporting groups
221180|NCT01305200|B3|Baseline|Arm III (Enrolled Not Randomized)|Site not able to randomize.
221181|NCT01305200|B2|Baseline|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221182|NCT01305200|B1|Baseline|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221183|NCT01305200|P3|Participant Flow|Arm III (Enrolled But Not Randomized)|Site not randomized
221184|NCT01305200|P2|Participant Flow|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221185|NCT01305200|P1|Participant Flow|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221186|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221187|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221188|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221189|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221190|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221191|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221192|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221193|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221194|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221195|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221276|NCT01304641|B2|Baseline|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
221196|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221197|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221198|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221199|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221200|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221201|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221202|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221203|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221204|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221205|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221206|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221207|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221208|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221209|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221210|NCT01305200|E2|Reported Event|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
supersaturated calcium phosphate rinse: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221211|NCT01305200|E1|Reported Event|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
placebo: Mouth rinse
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
221212|NCT01305044|B3|Baseline|Total|Total of all reporting groups
221213|NCT01305044|B2|Baseline|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221214|NCT01305044|B1|Baseline|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221215|NCT01305044|P2|Participant Flow|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221216|NCT01305044|P1|Participant Flow|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221217|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221218|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221219|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221220|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221221|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221222|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221223|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221224|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221225|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221226|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221227|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221228|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221229|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221230|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221231|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221277|NCT01304641|B1|Baseline|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
221278|NCT01304641|P2|Participant Flow|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
221232|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221233|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221234|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221235|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221236|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221237|NCT01305044|E2|Reported Event|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
221238|NCT01305044|E1|Reported Event|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
221239|NCT01304966|B1|Baseline|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
221240|NCT01304966|P1|Participant Flow|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
221241|NCT01304966|O2|Outcome|HPV 11|Children with recurrent respiratory papillomatosis from HPV 11
221242|NCT01304966|O1|Outcome|HPV 6|Children with recurrent respiratory papillomatosis from HPV 6
221243|NCT01304966|O1|Outcome|Children With Recurrent Respiratory Papillomatosis|Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy
221244|NCT01304966|E1|Reported Event|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
221245|NCT01304706|B1|Baseline|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
221246|NCT01304706|P1|Participant Flow|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
221247|NCT01304706|O1|Outcome|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
221248|NCT01304706|E1|Reported Event|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
221249|NCT01304693|B6|Baseline|Total|Total of all reporting groups
221250|NCT01304693|B5|Baseline|Lucentis|Single intravitreal injection with 6-month follow-up
221251|NCT01304693|B4|Baseline|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
221252|NCT01304693|B3|Baseline|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
221253|NCT01304693|B2|Baseline|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
221254|NCT01304693|B1|Baseline|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
221255|NCT01304693|P5|Participant Flow|Lucentis|Single intravitreal injection with 6-month follow-up
221256|NCT01304693|P4|Participant Flow|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
221257|NCT01304693|P3|Participant Flow|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
221258|NCT01304693|P2|Participant Flow|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
221259|NCT01304693|P1|Participant Flow|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
221260|NCT01304693|O5|Outcome|Lucentis|Single intravitreal injection with 6-month follow-up
221261|NCT01304693|O4|Outcome|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
221262|NCT01304693|O3|Outcome|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
221263|NCT01304693|O2|Outcome|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
221264|NCT01304693|O1|Outcome|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
221265|NCT01304693|O5|Outcome|Lucentis|Single intravitreal injection with 6-month follow-up
221266|NCT01304693|O4|Outcome|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
221267|NCT01304693|O3|Outcome|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
221268|NCT01304693|O2|Outcome|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
221269|NCT01304693|O1|Outcome|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
221270|NCT01304693|E5|Reported Event|Lucentis|Single intravitreal injection with 6-month follow-up
221271|NCT01304693|E4|Reported Event|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
221272|NCT01304693|E3|Reported Event|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
221279|NCT01304641|P1|Participant Flow|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
221280|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
221281|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
221282|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
221283|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
221284|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
221285|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
221286|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
221287|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
221288|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
221289|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
221290|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
221291|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
221292|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
221293|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
221294|NCT01304641|E2|Reported Event|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
221295|NCT01304641|E1|Reported Event|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
221296|NCT01304589|B1|Baseline|Milnacipram|Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
221297|NCT01304589|P1|Participant Flow|Milnacipran|Milnacipran: 6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose)for 12 weeks - total treatment period is 18 weeks
221298|NCT01304589|O1|Outcome|Milnacipram|Crossover study
221299|NCT01304589|O1|Outcome|Milnacipram|Crossover study
221300|NCT01304589|O1|Outcome|Milnacipran|Milnacipran: 6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose)for 12 weeks - total treatment period is 18 weeks
221301|NCT01304589|O1|Outcome|Milnacipram|open-label study
221302|NCT01304589|E1|Reported Event|Milnacipram|Crossover study
221303|NCT01304498|B3|Baseline|Total|Total of all reporting groups
221304|NCT01304498|B2|Baseline|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221305|NCT01304498|B1|Baseline|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221306|NCT01304498|P2|Participant Flow|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221307|NCT01304498|P1|Participant Flow|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221308|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221309|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221310|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221311|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221312|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221313|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221314|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221315|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221316|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221317|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221318|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221319|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221320|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221321|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221322|NCT01304498|O2|Outcome|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221323|NCT01304498|O1|Outcome|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221324|NCT01304498|E2|Reported Event|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221325|NCT01304498|E1|Reported Event|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
221326|NCT01304329|B1|Baseline|Study Overall|This was a randomised, 3-period, crossover trial. The trial was open label. The three treatments were separated by a washout period of at least 7 days.
221327|NCT01304329|P6|Participant Flow|Empa Plus Sim / Simvastatin Alone / Empa Alone|"Patients were administered three treatments in the following order:
A single dose of empagliflozin 25mg together with 40mg simvastatin
A single dose of simvastatin 40mg
A single dose of empagliflozin 25mg"
221328|NCT01304329|P5|Participant Flow|Empa Plus Sim / Empa Alone / Simvastatin Alone|"Patients were administered three treatments in the following order:
A single dose of empagliflozin 25mg together with 40mg simvastatin
A single dose of empagliflozin 25mg
A single dose of simvastatin 40mg"
221329|NCT01304329|P4|Participant Flow|Simvastatin Alone / Empa Plus Sim / Empa Alone|"Patients were administered three treatments in the following order:
A single dose of simvastatin 40mg
A single dose of empagliflozin 25mg together with 40mg simvastatin
A single dose of empagliflozin 25mg"
221330|NCT01304329|P3|Participant Flow|Simvastatin Alone / Empa Alone / Empa Plus Sim|"Patients were administered three treatments in the following order:
A single dose of simvastatin 40mg
A single dose of empagliflozin 25mg
A single dose of empagliflozin 25mg together with 40mg simvastatin"
221331|NCT01304329|P2|Participant Flow|Empa Alone / Empa Plus Sim / Simvastatin Alone|"Patients were administered three treatments in the following order:
A single dose of empagliflozin 25mg
A single dose of empagliflozin 25mg together with 40mg simvastatin
A single dose of simvastatin 40mg"
221332|NCT01304329|P1|Participant Flow|Empa Alone / Simvastatin Alone / Empa Plus Sim|"Patients were administered three treatments in the following order:
A single dose of empagliflozin 25mg
A single dose of simvastatin 40mg
A single dose of empagliflozin 25mg together with 40mg simvastatin"
221333|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
221334|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
221335|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
221336|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
221337|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
221338|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
221339|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
221340|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
221341|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
221342|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
221343|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
221344|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
221345|NCT01304329|E3|Reported Event|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
221346|NCT01304329|E2|Reported Event|Simvastatin Alone|40 mg simvastatin alone
221347|NCT01304329|E1|Reported Event|Empa Alone|25mg empagliflozin (empa) alone
221348|NCT01304316|B1|Baseline|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221349|NCT01304316|P1|Participant Flow|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221350|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221351|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221352|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221353|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221354|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221355|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221356|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221357|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221358|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221359|NCT01304316|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
221360|NCT01304316|E2|Reported Event|High K305 Dose|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
221361|NCT01304316|E1|Reported Event|Standard K305 Dose|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl
221362|NCT01304277|B1|Baseline|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
221363|NCT01304277|P1|Participant Flow|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
221364|NCT01304277|O3|Outcome|Overall|Overall number of patients who experienced adverse events during the course of REP-082 study.
221365|NCT01304277|O2|Outcome|Replagal AF|Patients received 7 EOW infusions of treatment with Replagal AF from week 2 to week 14 in REP-082.
221366|NCT01304277|O1|Outcome|Replagal RB|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082.
221367|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
221368|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
221369|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
221370|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
221371|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
221372|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
221373|NCT01304277|E1|Reported Event|Replagal® (0.2 mg/kg, IV, EOW)|Overall patients that participated in REP-082
221374|NCT01304238|B11|Baseline|Total|Total of all reporting groups
221375|NCT01304238|B10|Baseline|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
221376|NCT01304238|B9|Baseline|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
221377|NCT01304238|B8|Baseline|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
221378|NCT01304238|B7|Baseline|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
221379|NCT01304238|B6|Baseline|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
221380|NCT01304238|B5|Baseline|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
221381|NCT01304238|B4|Baseline|Fondaparinux|Participants treated with fondaparinux after HIT II
221382|NCT01304238|B3|Baseline|Danaparoid|Participants treated with danaparoid after HIT II
221383|NCT01304238|B2|Baseline|Lepirudin|Participants treated with lepirudin after HIT II
221384|NCT01304238|B1|Baseline|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
221440|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
221385|NCT01304238|P10|Participant Flow|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
221386|NCT01304238|P9|Participant Flow|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
221387|NCT01304238|P8|Participant Flow|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
221388|NCT01304238|P7|Participant Flow|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
221389|NCT01304238|P6|Participant Flow|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
221390|NCT01304238|P5|Participant Flow|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
221391|NCT01304238|P4|Participant Flow|Fondaparinux|Participants treated with fondaparinux after HIT II
221392|NCT01304238|P3|Participant Flow|Danaparoid|Participants treated with danaparoid after HIT II
221393|NCT01304238|P2|Participant Flow|Lepirudin|Participants treated with lepirudin after HIT II
221394|NCT01304238|P1|Participant Flow|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
221395|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
221396|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
221397|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
221398|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
221399|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
221400|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
221401|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
221402|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
221403|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
221404|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
221405|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
221406|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
221407|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
221408|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
221409|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
221410|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
221411|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
221412|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
221413|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
221414|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
221415|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
221416|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
221417|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
221418|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
221419|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
221420|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
221421|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
221422|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
221423|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
221424|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
221425|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
221426|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
221427|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
221428|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
221429|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
221430|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
221431|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
221432|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
221433|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
221434|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
221435|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
221436|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
221437|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
221438|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
221439|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
221444|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
221445|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
221446|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
221447|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
221448|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
221449|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
221450|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
221451|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
221452|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
221453|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
221454|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
221455|NCT01304238|E10|Reported Event|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
221456|NCT01304238|E9|Reported Event|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
221457|NCT01304238|E8|Reported Event|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
221458|NCT01304238|E7|Reported Event|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
221459|NCT01304238|E6|Reported Event|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
221460|NCT01304238|E5|Reported Event|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
221461|NCT01304238|E4|Reported Event|Fondaparinux|Participants treated with fondaparinux after HIT II
221462|NCT01304238|E3|Reported Event|Danaparoid|Participants treated with danaparoid after HIT II
221463|NCT01304238|E2|Reported Event|Lepirudin|Participants treated with lepirudin after HIT II
221464|NCT01304238|E1|Reported Event|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
221465|NCT01304147|B1|Baseline|Participants Treated|
221466|NCT01304147|P2|Participant Flow|Placebo, Then Ketamine|placebo: Single dose of saline (0.9% saline solution) intranasal for 7 days in first intervention, then Ketamine 50mg in second intervention.
221467|NCT01304147|P1|Participant Flow|Ketamine Then Placebo|Ketamine: A single dose of intranasal ketamine up to 50 mg for 7 days in first intervention. Then Placebo for 7 days in 2nd intervention.
221468|NCT01304147|O2|Outcome|Placebo|placebo: Single dose of saline intranasal
221469|NCT01304147|O1|Outcome|Ketamine|Ketamine: A single dose of intranasal ketamine up to 50 mg
221470|NCT01304147|O2|Outcome|Placebo|placebo: Single dose of saline intranasal
221471|NCT01304147|O1|Outcome|Ketamine|Ketamine: A single dose of intranasal ketamine up to 50 mg
221472|NCT01304147|E2|Reported Event|Placebo|
221473|NCT01304147|E1|Reported Event|Ketamine|
221474|NCT01304082|B1|Baseline|All Study Participants|All study participants
221475|NCT01304082|P5|Participant Flow|A, L, C|alkalinized lidocaine, lidocaine, control
221476|NCT01304082|P4|Participant Flow|A, C, L|alkalinized lidocaine, control, lidocaine
221477|NCT01304082|P3|Participant Flow|L, C, A|lidocaine, control, alkalinized lidocaine
221478|NCT01304082|P2|Participant Flow|C, A, L|control, alkalinized lidocaine, lidocaine
221479|NCT01304082|P1|Participant Flow|C, L, A|control, lidocaine, alkalinized lidocaine
221480|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
221481|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
221482|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
221483|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
221484|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
221485|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
221486|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
221487|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
221488|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
221489|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
221490|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
221491|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
221492|NCT01304082|E3|Reported Event|Alkalinized Lidocaine|1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
221493|NCT01304082|E2|Reported Event|Lidocaine|1 ml subcutaneous injection of 0.9% lidocaine, given once
221494|NCT01304082|E1|Reported Event|Normal Saline|1 ml subcutaneous injection 0.9% sodium chloride, given once
221495|NCT01303861|B6|Baseline|Total|Total of all reporting groups
221496|NCT01303861|B5|Baseline|Dropped Prior to Condition Assignment|These subjects discontinued study participation prior to being assigned to a condition.
221534|NCT01303835|E1|Reported Event|Naltrexone|Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed.
221535|NCT01303744|B5|Baseline|Total|Total of all reporting groups
221536|NCT01303744|B4|Baseline|Placebo|"placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks"
221684|NCT01303224|E3|Reported Event|Ibodutant 10 mg|oral tablet, once daily
221497|NCT01303861|B4|Baseline|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221498|NCT01303861|B3|Baseline|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
221499|NCT01303861|B2|Baseline|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week"
221500|NCT01303861|B1|Baseline|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221501|NCT01303861|P4|Participant Flow|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221502|NCT01303861|P3|Participant Flow|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
221503|NCT01303861|P2|Participant Flow|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week"
221504|NCT01303861|P1|Participant Flow|Varenicline|"This group will consist of smokers who, based on smoking behavior, Do NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221537|NCT01303744|B3|Baseline|CHF 5074 3x|"oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
221538|NCT01303744|B2|Baseline|CHF 5074 2x|"oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
221539|NCT01303744|B1|Baseline|CHF 5074 1x|"oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
221540|NCT01303744|P4|Participant Flow|Placebo|"placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks"
221505|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221506|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
221507|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week"
221508|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221509|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221510|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
221511|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week"
221512|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221513|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221514|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
221515|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week"
221516|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221517|NCT01303861|E5|Reported Event|Dropped Prior to Condition Assignment|These subjects discontinued study participation prior to being assigned to a condition.
221518|NCT01303861|E4|Reported Event|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221519|NCT01303861|E3|Reported Event|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
221520|NCT01303861|E2|Reported Event|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week"
221521|NCT01303861|E1|Reported Event|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
221522|NCT01303835|B3|Baseline|Total|Total of all reporting groups
221523|NCT01303835|B2|Baseline|Placebo|Randomized patients received placebo to be taken every night before bed.
221524|NCT01303835|B1|Baseline|Naltrexone|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
221525|NCT01303835|P2|Participant Flow|Placebo|Randomized patients received placebo to be taken every night before bed.
221526|NCT01303835|P1|Participant Flow|Naltrexone|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
221527|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
221528|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
221529|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
221530|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
221531|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
221532|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
221533|NCT01303835|E2|Reported Event|Placebo|Randomized patients received placebo to be taken every night before bed.
221541|NCT01303744|P3|Participant Flow|CHF 5074 3x|"oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
221542|NCT01303744|P2|Participant Flow|CHF 5074 2x|"oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
221543|NCT01303744|P1|Participant Flow|CHF 5074 1x|"oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
221544|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks"
221545|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
221546|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
221547|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
221548|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks"
221549|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
221550|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
221551|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
221552|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks"
221553|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
221554|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
221555|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
221556|NCT01303744|E4|Reported Event|Placebo|"placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks"
221557|NCT01303744|E3|Reported Event|CHF 5074 3x|"oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
221558|NCT01303744|E2|Reported Event|CHF 5074 2x|"oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
221559|NCT01303744|E1|Reported Event|CHF 5074 1x|"oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
221560|NCT01303627|B3|Baseline|Total|Total of all reporting groups
221561|NCT01303627|B2|Baseline|Control|Control:Remifentanil stopped at the end of the surgery
221562|NCT01303627|B1|Baseline|Ultiva,Remifentanil,Opioid,Analgesic|Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
221563|NCT01303627|P2|Participant Flow|Control|Control:Remifentanil stopped at the end of the surgery
221564|NCT01303627|P1|Participant Flow|Ultiva,Remifentanil,Opioid,Analgesic|Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
221565|NCT01303627|O2|Outcome|Control Group|Remifentanil stopped at the and of the surgery
221566|NCT01303627|O1|Outcome|Remifentanil Group|remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal
221567|NCT01303627|E2|Reported Event|Control Group|Remifentanil stopped at the end of the surgery
221568|NCT01303627|E1|Reported Event|Remifentanil Group|remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal
221569|NCT01303510|B3|Baseline|Total|Total of all reporting groups
221570|NCT01303510|B2|Baseline|Group B|Elderly subjects aged over 60 years
221571|NCT01303510|B1|Baseline|Group A|Adults from 18 to 60 years old inclusive
221572|NCT01303510|P2|Participant Flow|Group B|Elderly subjects aged over 60 years
221573|NCT01303510|P1|Participant Flow|Group A|Adults from 18 to 60 years old inclusive
221574|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
221575|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
221576|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
221577|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
221578|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
221579|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
221580|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
221581|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
221582|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
221583|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
221584|NCT01303510|E2|Reported Event|Group B|Elderly subjects aged over 60 years
221585|NCT01303510|E1|Reported Event|Group A|Adults from 18 to 60 years old inclusive
221586|NCT01303445|B1|Baseline|Entire Study Population|
221587|NCT01303445|P2|Participant Flow|CDAB Sequence|Omeprazole/Aggrenox+Omeprazole/Aggrenox/Aggrenox+Omeprazole
221588|NCT01303445|P1|Participant Flow|ABCD Sequence|Aggrenox/Aggrenox+Omeprazole/Omeprazole/Aggrenox+Omeprazole
221589|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
221590|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
221656|NCT01303224|B3|Baseline|Ibodutant 10 mg|oral tablet, once daily
221591|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
221592|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
221593|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
221594|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
221595|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
221596|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
221597|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
221598|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
221599|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
221600|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
221601|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
221602|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
221603|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
221604|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
221605|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
221606|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
221607|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
221608|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
221609|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
221610|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
221611|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
221612|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
221613|NCT01303445|E4|Reported Event|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
221614|NCT01303445|E3|Reported Event|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
221615|NCT01303445|E2|Reported Event|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
221616|NCT01303445|E1|Reported Event|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
221617|NCT01303406|B3|Baseline|Total|Total of all reporting groups
221618|NCT01303406|B2|Baseline|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:
Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals
Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals
Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
221619|NCT01303406|B1|Baseline|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:
Placebo Patients < 45 kg - 3 tablets 3 times a day with meals
Placebo Patients > 45 kg - 5 tablets 3 times a day with meals
Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
221620|NCT01303406|P2|Participant Flow|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:
Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals
Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals
Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
221621|NCT01303406|P1|Participant Flow|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:
Placebo Patients < 45 kg - 3 tablets 3 times a day with meals
Placebo Patients > 45 kg - 5 tablets 3 times a day with meals
Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
221622|NCT01303406|O2|Outcome|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:
Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals
Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals
Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
221657|NCT01303224|B2|Baseline|Ibodutant 3 mg|oral tablet, once daily
221658|NCT01303224|B1|Baseline|Ibodutant 1 mg|oral tablet, once daily
221623|NCT01303406|O1|Outcome|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:
Placebo Patients < 45 kg - 3 tablets 3 times a day with meals
Placebo Patients > 45 kg - 5 tablets 3 times a day with meals
Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
221624|NCT01303406|O2|Outcome|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:
Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals
Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals
Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
221625|NCT01303406|O1|Outcome|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:
Placebo Patients < 45 kg - 3 tablets 3 times a day with meals
Placebo Patients > 45 kg - 5 tablets 3 times a day with meals
Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
221626|NCT01303406|E2|Reported Event|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:
Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals
Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals
Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
221627|NCT01303406|E1|Reported Event|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:
Placebo Patients < 45 kg - 3 tablets 3 times a day with meals
Placebo Patients > 45 kg - 5 tablets 3 times a day with meals
Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
221628|NCT01303380|B1|Baseline|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221629|NCT01303380|P1|Participant Flow|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new Hyper-IgD with periodic fever syndrome (HIDS) flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221630|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221631|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221632|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221633|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221659|NCT01303224|P4|Participant Flow|Placebo|oral tablet, once daily
221634|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221635|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221636|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221637|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221638|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221639|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221640|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221641|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221642|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221643|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221660|NCT01303224|P3|Participant Flow|Ibodutant 10 mg|oral tablet, once daily
221661|NCT01303224|P2|Participant Flow|Ibodutant 3 mg|oral tablet, once daily
221644|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221645|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221646|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221647|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221648|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221649|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221650|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221651|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221652|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221653|NCT01303380|E1|Reported Event|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator’s discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
221654|NCT01303224|B5|Baseline|Total|Total of all reporting groups
221655|NCT01303224|B4|Baseline|Placebo|oral tablet, once daily
221685|NCT01303224|E2|Reported Event|Ibodutant 3 mg|oral tablet, once daily
221686|NCT01303224|E1|Reported Event|Ibodutant 1 mg|oral tablet, once daily
221687|NCT01303159|B1|Baseline|Radiofrequency Probe (ENDOHPB)|Intervention: The EndoHPB Radiofrequency probe
221688|NCT01303159|P1|Participant Flow|Radiofrequency Probe (ENDOHPB)|"Intervention:
The EndoHPB Radiofrequency probe"
221689|NCT01303159|O1|Outcome|Radiofrequency Probe (ENDOHPB)|"Intervention:
The EndoHPB Radiofrequency probe"
221690|NCT01303159|O1|Outcome|Radiofrequency Probe (ENDOHPB)|"Intervention:
The EndoHPB Radiofrequency probe"
221691|NCT01303159|E1|Reported Event|Radiofrequency Probe (ENDOHPB)|"Intervention:
The EndoHPB Radiofrequency probe"
221692|NCT01302938|B3|Baseline|Total|Total of all reporting groups
221693|NCT01302938|B2|Baseline|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221694|NCT01302938|B1|Baseline|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221695|NCT01302938|P2|Participant Flow|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221696|NCT01302938|P1|Participant Flow|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221697|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221698|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221699|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221700|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221701|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221702|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221703|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221704|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221705|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
221706|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221707|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221708|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
221709|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
221710|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
221711|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
221712|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221713|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221714|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221715|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221716|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221717|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221718|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221719|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221720|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221721|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221722|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221723|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221724|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221725|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221726|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221727|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221728|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221729|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221730|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221731|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221732|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221733|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221734|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221735|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221736|NCT01302938|E2|Reported Event|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
221737|NCT01302938|E1|Reported Event|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
221738|NCT01302899|B3|Baseline|Total|Total of all reporting groups
221739|NCT01302899|B2|Baseline|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.
Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.
Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.
Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
221740|NCT01302899|B1|Baseline|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.
Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.
Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.
Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
221741|NCT01302899|P2|Participant Flow|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.
Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.
Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.
Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
221742|NCT01302899|P1|Participant Flow|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.
Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.
Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.
Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
221743|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221744|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221745|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221746|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221747|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221748|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221749|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221750|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221751|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221752|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221753|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221754|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221755|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221756|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221757|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221758|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221759|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221760|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221761|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221762|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221763|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221764|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221765|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221766|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221767|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221768|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221769|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221770|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221771|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221772|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221773|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221774|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221775|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221776|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221777|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221778|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221779|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221780|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221781|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221782|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221783|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221784|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221867|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Number of subjects able to complete the dental procedure without rescue
221785|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221786|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221787|NCT01302899|E4|Reported Event|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
221788|NCT01302899|E3|Reported Event|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ
*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221789|NCT01302899|E2|Reported Event|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg
* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
221790|NCT01302899|E1|Reported Event|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
221791|NCT01302860|B1|Baseline|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
221792|NCT01302860|P1|Participant Flow|Canakinumab|Participants received body weight stratified dose of canakinumab 2 milligrams/kilogram (mg/kg) subcutaneous (s.c.) injection every 8 weeks.
221793|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
221794|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
221795|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
221796|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
221797|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
221798|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
221799|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
221800|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
221801|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
221802|NCT01302860|E1|Reported Event|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
221803|NCT01302743|B4|Baseline|Total|Total of all reporting groups
221804|NCT01302743|B3|Baseline|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days
Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
221805|NCT01302743|B2|Baseline|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days
Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
221806|NCT01302743|B1|Baseline|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days
Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
221807|NCT01302743|P3|Participant Flow|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days
Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
221808|NCT01302743|P2|Participant Flow|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days
Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
221809|NCT01302743|P1|Participant Flow|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days
Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
221810|NCT01302743|O3|Outcome|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days
Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
221811|NCT01302743|O2|Outcome|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days
Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
221812|NCT01302743|O1|Outcome|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days
Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
221813|NCT01302743|O3|Outcome|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days
Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
221814|NCT01302743|O2|Outcome|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days
Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
221815|NCT01302743|O1|Outcome|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days
Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
221816|NCT01302743|E3|Reported Event|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days
Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
221817|NCT01302743|E2|Reported Event|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days
Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
221818|NCT01302743|E1|Reported Event|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days
Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
221819|NCT01302691|B3|Baseline|Total|Total of all reporting groups
221820|NCT01302691|B2|Baseline|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221821|NCT01302691|B1|Baseline|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221868|NCT01302483|E2|Reported Event|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
221822|NCT01302691|P2|Participant Flow|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221823|NCT01302691|P1|Participant Flow|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221824|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221825|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221826|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221827|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221828|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221829|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221830|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221831|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221832|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221833|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221834|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221835|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221836|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221837|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221838|NCT01302691|E2|Reported Event|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221839|NCT01302691|E1|Reported Event|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
221840|NCT01302548|B3|Baseline|Total|Total of all reporting groups
221841|NCT01302548|B2|Baseline|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
221842|NCT01302548|B1|Baseline|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
221843|NCT01302548|P2|Participant Flow|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
221844|NCT01302548|P1|Participant Flow|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
221845|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
221846|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
221847|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
221848|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
221849|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
221850|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
221851|NCT01302548|E2|Reported Event|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
221852|NCT01302548|E1|Reported Event|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
221853|NCT01302483|B3|Baseline|Total|Total of all reporting groups
221854|NCT01302483|B2|Baseline|Lidocaine Injection|
221855|NCT01302483|B1|Baseline|Kovacaine Nasal Spray|
221856|NCT01302483|P2|Participant Flow|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
221857|NCT01302483|P1|Participant Flow|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
221858|NCT01302483|O2|Outcome|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
221859|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
221860|NCT01302483|O2|Outcome|Lidocaine Injection|Blood Pressure Maximum Change from Baseline
221861|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Blood Pressure Maximum Change from Baseline
221862|NCT01302483|O2|Outcome|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
221863|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
221864|NCT01302483|O2|Outcome|Lidocaine Injection|Duration of Soft Tissue Anesthesia
221865|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Duration of Soft Tissue Anesthesia
221866|NCT01302483|O2|Outcome|Lidocaine Injection|Number of subjects able to complete the dental procedure without rescue
221869|NCT01302483|E1|Reported Event|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
221870|NCT01302444|B3|Baseline|Total|Total of all reporting groups
221871|NCT01302444|B2|Baseline|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
221872|NCT01302444|B1|Baseline|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
221873|NCT01302444|P2|Participant Flow|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
221874|NCT01302444|P1|Participant Flow|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
221875|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
221876|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
221877|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
221878|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
221879|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
221880|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
221881|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
221882|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
221883|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
221884|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
221885|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
221886|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
221887|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
221888|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
221889|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
221890|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
221891|NCT01302444|E2|Reported Event|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
221892|NCT01302444|E1|Reported Event|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
221893|NCT01302418|B1|Baseline|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
221894|NCT01302418|P1|Participant Flow|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
221895|NCT01302418|O1|Outcome|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
221896|NCT01302418|E1|Reported Event|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
221897|NCT01302392|B3|Baseline|Total|Total of all reporting groups
221898|NCT01302392|B2|Baseline|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
221899|NCT01302392|B1|Baseline|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
221900|NCT01302392|P2|Participant Flow|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
221901|NCT01302392|P1|Participant Flow|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
221902|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
221903|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
221924|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
221904|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
221905|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
221906|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
221907|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
221908|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
221909|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
221910|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
221911|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
221912|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
221913|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
221914|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
221915|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
221916|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
221917|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
221918|NCT01302392|E2|Reported Event|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
221919|NCT01302392|E1|Reported Event|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
221920|NCT01302366|B1|Baseline|Sea Cucumber Extract (TBL 12)|"TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
TBL-12"
221921|NCT01302366|P1|Participant Flow|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
221922|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
221923|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
221925|NCT01302366|E1|Reported Event|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
221926|NCT01302119|B3|Baseline|Total|Total of all reporting groups
221927|NCT01302119|B2|Baseline|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
221928|NCT01302119|B1|Baseline|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
221929|NCT01302119|P2|Participant Flow|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
221930|NCT01302119|P1|Participant Flow|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
221931|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
221932|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
221933|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
221934|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
221935|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
221936|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
221937|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
221938|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
221939|NCT01302119|E2|Reported Event|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
221940|NCT01302119|E1|Reported Event|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
221941|NCT01302067|B4|Baseline|Total|Total of all reporting groups
221942|NCT01302067|B3|Baseline|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221943|NCT01302067|B2|Baseline|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221944|NCT01302067|B1|Baseline|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221945|NCT01302067|P3|Participant Flow|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221946|NCT01302067|P2|Participant Flow|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221947|NCT01302067|P1|Participant Flow|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221948|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221949|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221950|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221951|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221952|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221953|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221954|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221955|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221956|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221957|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221958|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221959|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221960|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221961|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221962|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221963|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221964|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221965|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221966|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221967|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221968|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221969|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221970|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221971|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221972|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221973|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221974|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221975|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221976|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221977|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221978|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221979|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221980|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221981|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221982|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221983|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221984|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221985|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221986|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221987|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221988|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221989|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221990|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221991|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221992|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221993|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221994|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221995|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221996|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
221997|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
221998|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
221999|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
222000|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
222001|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
222002|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
222003|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
222004|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
222005|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
222006|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
222007|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
222008|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
222009|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
222010|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
222011|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
222012|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
222013|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
222014|NCT01302067|E3|Reported Event|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
222015|NCT01302067|E2|Reported Event|Placebo|Participants received one tablet of placebo per day for 12 weeks.
222016|NCT01302067|E1|Reported Event|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
222017|NCT01302054|B1|Baseline|Entire Study Population|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had <= 50 percent change in UUI episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
222018|NCT01302054|P3|Participant Flow|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222019|NCT01302054|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222020|NCT01302054|P1|Participant Flow|Tolterodine|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
222021|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222022|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222023|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222024|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222025|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222026|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222027|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222028|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222029|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222030|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222031|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222032|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222033|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222034|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222035|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222036|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222037|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222038|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222039|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222040|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222041|NCT01302054|O2|Outcome|Fesoterodine: Double-Blind Week 12|Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222042|NCT01302054|O1|Outcome|Fesoterodine: Double-Blind Baseline|Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222043|NCT01302054|E3|Reported Event|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
222044|NCT01302054|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
222045|NCT01302054|E1|Reported Event|Tolterodine|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
222046|NCT01302041|B1|Baseline|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222047|NCT01302041|P1|Participant Flow|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222048|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222049|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222050|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222051|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222052|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222053|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222054|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222055|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222056|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222057|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222058|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222059|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222060|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222061|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222062|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222063|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222064|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222065|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222066|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222067|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222116|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
222068|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222069|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222070|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222071|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222072|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222073|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222074|NCT01302041|E1|Reported Event|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
222075|NCT01301963|B3|Baseline|Total|Total of all reporting groups
222076|NCT01301963|B2|Baseline|Arm II|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
plerixafor: Given SC
filgrastim: Given SC"
222077|NCT01301963|B1|Baseline|Arm I|"Patients receive G-CSF SC QD on days 1-4.
filgrastim: Given SC"
222078|NCT01301963|P2|Participant Flow|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
plerixafor: Given SC
filgrastim: Given SC"
222079|NCT01301963|P1|Participant Flow|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.
filgrastim: Given SC"
222080|NCT01301963|O2|Outcome|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
plerixafor: Given SC
filgrastim: Given SC"
222081|NCT01301963|O1|Outcome|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.
filgrastim: Given SC"
222082|NCT01301963|O2|Outcome|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
plerixafor: Given SC
filgrastim: Given SC"
222083|NCT01301963|O1|Outcome|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.
filgrastim: Given SC"
222084|NCT01301963|E2|Reported Event|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
plerixafor: Given SC
filgrastim: Given SC"
222085|NCT01301963|E1|Reported Event|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.
filgrastim: Given SC"
222086|NCT01301950|B3|Baseline|Total|Total of all reporting groups
222087|NCT01301950|B2|Baseline|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
222088|NCT01301950|B1|Baseline|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon
222089|NCT01301950|P2|Participant Flow|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
222090|NCT01301950|P1|Participant Flow|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
222091|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
222092|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
222117|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
222093|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
222094|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
222095|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
222096|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
222097|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
222098|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
222099|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
222100|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
222101|NCT01301950|E2|Reported Event|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
222102|NCT01301950|E1|Reported Event|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions Instrument: TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon
222103|NCT01301833|B5|Baseline|Total|Total of all reporting groups
222104|NCT01301833|B4|Baseline|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
222105|NCT01301833|B3|Baseline|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
222106|NCT01301833|B2|Baseline|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
222107|NCT01301833|B1|Baseline|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
222108|NCT01301833|P4|Participant Flow|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
222109|NCT01301833|P3|Participant Flow|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
222110|NCT01301833|P2|Participant Flow|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
222111|NCT01301833|P1|Participant Flow|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
222112|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
222113|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
222114|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
222115|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
222118|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
222119|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
222120|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
222121|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
222122|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
222123|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
222124|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
222125|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
222126|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
222127|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
222128|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
222129|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
222130|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
222131|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
222132|NCT01301833|E4|Reported Event|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
222133|NCT01301833|E3|Reported Event|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
222134|NCT01301833|E2|Reported Event|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
222135|NCT01301833|E1|Reported Event|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
222136|NCT01301742|B1|Baseline|Entire Study Population|"The two treatments given in a randomised order were:
Empagliflozin 25mg (Empa) was given as a single dose on Day 1
Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empa was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
Between treatments there was a washout period of at least 7 days."
222137|NCT01301742|P2|Participant Flow|Empa and Gemfibrozil First, Then Empa|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions. This was followed by a washout period of at least 7 days, followed by Empa given as a single dose on Day 1.
222138|NCT01301742|P1|Participant Flow|Empa First, Then Empa and Gemfibrozil|Empagliflozin 25mg (Empa) was given as a single dose on Day 1, followed by a washout period of at least 7 days, followed by Gemfibrozil 600mg given twice daily for 5 days starting on day -2 and empa given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
222139|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
222140|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
222141|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
222142|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
222143|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
222144|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
222145|NCT01301742|E3|Reported Event|Gemfibrozil Alone|Between the first gemfibrozil administration and the empagliflozin administration, for the Empa and gemfibrozil treatment period.
222146|NCT01301742|E2|Reported Event|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
222147|NCT01301742|E1|Reported Event|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
222148|NCT01301729|B1|Baseline|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
222149|NCT01301729|P1|Participant Flow|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
222150|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
222151|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
222152|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
222153|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
222154|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
222155|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
222156|NCT01301729|O1|Outcome|Tastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
222157|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
222158|NCT01301729|E1|Reported Event|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
222159|NCT01301508|B3|Baseline|Total|Total of all reporting groups
222160|NCT01301508|B2|Baseline|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222161|NCT01301508|B1|Baseline|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222162|NCT01301508|P2|Participant Flow|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222163|NCT01301508|P1|Participant Flow|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate atopic dermatitis (AD) applied AN2898 ointment, 1 percent (%) to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222164|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222165|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222166|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222167|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222168|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222169|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222170|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222171|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222172|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222173|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222174|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222175|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222176|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222177|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222178|NCT01301508|E2|Reported Event|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222179|NCT01301508|E1|Reported Event|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
222180|NCT01301274|B3|Baseline|Total|Total of all reporting groups
222181|NCT01301274|B2|Baseline|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
222182|NCT01301274|B1|Baseline|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
222183|NCT01301274|P2|Participant Flow|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
222184|NCT01301274|P1|Participant Flow|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
222185|NCT01301274|O2|Outcome|Isotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
222186|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
222187|NCT01301274|O2|Outcome|Isotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
222188|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received fro maintenance solution ClNa 0.45% in Dx 5%
222189|NCT01301274|O2|Outcome|Isotonic Arm|patients who received maintenance solution 0.9% ClNa in Dx 5%
222190|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received maintenance solution 0.45% ClNa in Dx 5%
222191|NCT01301274|O2|Outcome|Isotonic Arm|Patients who received for maintenance solution 0.9% ClNa in Dx 5%
222192|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received for maintenance solution 0.45% ClNa in Dx 5%
222193|NCT01301274|E2|Reported Event|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
222194|NCT01301274|E1|Reported Event|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
222195|NCT01301092|B4|Baseline|Total|Total of all reporting groups
222196|NCT01301092|B3|Baseline|Part C: LY2189265 Subcutaneous, Intramuscular|Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
222197|NCT01301092|B2|Baseline|Part B: LY2189265 Subcutaneous, Intravenous|Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
222198|NCT01301092|B1|Baseline|Part A: LY2189265 Intravenous|Single 0.1 milligram (mg) intravenous (IV) dose of LY2189265
222324|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
223106|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
222199|NCT01301092|P3|Participant Flow|Part C: LY2189265 Subcutaneous, Intramuscular|Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
222200|NCT01301092|P2|Participant Flow|Part B: LY2189265 Subcutaneous, Intravenous|Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
222201|NCT01301092|P1|Participant Flow|Part A: LY2189265 Intravenous|Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265.
222202|NCT01301092|O2|Outcome|Part C: LY2189265 Subcutaneous|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2
222203|NCT01301092|O1|Outcome|Part C: LY2189265 Intramuscular|Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1 or 2
222204|NCT01301092|O2|Outcome|Part C: LY2189265 Subcutaneous|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2
222205|NCT01301092|O1|Outcome|Part C: LY2189265 Intramuscular|Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1or 2
222206|NCT01301092|O2|Outcome|Part B: LY2189265 Intravenous|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
222207|NCT01301092|O1|Outcome|Part B: LY2189265 Subcutaneous|Single 1.5-milligram (mg) subcutaneous (SC) dose of LY2189265 in Period 1 or 2
222208|NCT01301092|O2|Outcome|Part B: LY2189265 Intravenous|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
222209|NCT01301092|O1|Outcome|Part B: LY2189265 Subcutaneous|Single 1.5 mg-subcutaneous (SC) dose of LY2189265 in Period 1 or 2
222210|NCT01301092|E5|Reported Event|Part C: 0.75 mg SC LY2189265|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
222211|NCT01301092|E4|Reported Event|Part C: 0.75 mg IM LY2189265|Single 0.75-mg intramuscular (IM) of LY2189265 in Period 1 or 2.
222212|NCT01301092|E3|Reported Event|Part B: 1.5 mg SC LY2189265|Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
222213|NCT01301092|E2|Reported Event|Part B: 0.1 mg IV LY2189265|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2.
222214|NCT01301092|E1|Reported Event|Part A: 0.1 mg IV LY2189265|Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265
222215|NCT01301079|B3|Baseline|Total|Total of all reporting groups
222216|NCT01301079|B2|Baseline|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. Patients in group 2 (G2) received remifentanil (0.4 μg/kg/min) and saline solution.
Saline : Patients in group N (placebo)will receive saline during surgery."
222217|NCT01301079|B1|Baseline|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min).
Ketamine : Patients in group ketamine will receive ketamine (5mcg/kg/min) during the surgery."
222218|NCT01301079|P2|Participant Flow|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222219|NCT01301079|P1|Participant Flow|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222220|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222221|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222222|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
223107|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
222223|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222224|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222225|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222226|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222227|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222228|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222229|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222230|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222231|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222232|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222233|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222325|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
222326|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
223815|NCT01296646|O1|Outcome|Placebo|Placebo taken once daily.
222234|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222235|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222236|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222237|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222238|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222239|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222240|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222241|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222242|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222243|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222244|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222327|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
222328|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day).
323832|NCT00283842|O5|Outcome|Placebo|
222245|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222246|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222247|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222248|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222249|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222250|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222251|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222252|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222253|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222254|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222255|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222329|NCT01300923|E1|Reported Event|Acamprosate|The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg.
222330|NCT01300819|B3|Baseline|Total|Total of all reporting groups
222256|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222257|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222258|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222259|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222260|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222261|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222262|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222263|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222264|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222265|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222266|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
223816|NCT01296646|O2|Outcome|Naltrexone|50 mg of naltrexone orally daily.
222267|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222268|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222269|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222270|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222271|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222272|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222273|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222274|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222275|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222276|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222277|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
223817|NCT01296646|O1|Outcome|Placebo|Placebo taken once daily.
222278|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222279|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
222280|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222281|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222282|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222283|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222284|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution.
Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.
Saline: Patients in group N (placebo) was administrated saline during surgery."
222285|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min).
Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.
Ketamine: Patients in group ketamine was administrated ketamine (5mcg/kg/min) during the surgery."
222286|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222287|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222288|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222289|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222290|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222291|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222292|NCT01301079|E2|Reported Event|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222293|NCT01301079|E1|Reported Event|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.
The patients in group ketamine received remifentanil (0.4 μg/kg/min) and (ketamine 5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
222294|NCT01301066|B3|Baseline|Total|Total of all reporting groups
222295|NCT01301066|B2|Baseline|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
222296|NCT01301066|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
222297|NCT01301066|P2|Participant Flow|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
222298|NCT01301066|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
222299|NCT01301066|O2|Outcome|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
222300|NCT01301066|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
222301|NCT01301066|E2|Reported Event|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
222302|NCT01301066|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
222303|NCT01301027|B3|Baseline|Total|Total of all reporting groups
222304|NCT01301027|B2|Baseline|Placebo|Placebo: 1 pill a day for 26 weeks
222305|NCT01301027|B1|Baseline|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
222306|NCT01301027|P2|Participant Flow|Placebo|Placebo: 1 pill a day for 26 weeks
222307|NCT01301027|P1|Participant Flow|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
222308|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
222309|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
222310|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
222311|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
222312|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
222313|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
222314|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
222315|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
222316|NCT01301027|E2|Reported Event|Placebo|"1 placebo pill a day matching the pioglitazone treatment for 26 weeks
Placebo: 1 pill a day for 26 weeks"
222317|NCT01301027|E1|Reported Event|Pioglitazone|"15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks"
222318|NCT01300923|B1|Baseline|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
222319|NCT01300923|P2|Participant Flow|Autism Spectrum Disorder (ADS)|This baseline comparison group will participated in only and biomarker portion of subject characterization.
222320|NCT01300923|P1|Participant Flow|Acamprosate|"The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg.
Acamprosate"
222321|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
222322|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
222323|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day).
222331|NCT01300819|B2|Baseline|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222332|NCT01300819|B1|Baseline|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222333|NCT01300819|P2|Participant Flow|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222334|NCT01300819|P1|Participant Flow|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222335|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222336|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222337|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222338|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222339|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222340|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222341|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222342|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222343|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
223110|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
222344|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222345|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222346|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222347|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222348|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222349|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222350|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222351|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222352|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222353|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222354|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222355|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222356|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
223108|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
222357|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222358|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222359|NCT01300819|E2|Reported Event|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222360|NCT01300819|E1|Reported Event|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
222361|NCT01300767|B1|Baseline|Lotrafilcon B /Balafilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
222362|NCT01300767|P1|Participant Flow|Lotrafilcon B /Balafilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
222363|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222364|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222365|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222366|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222367|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222368|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222369|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222370|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222371|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222372|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222373|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222374|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222375|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222376|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222377|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222378|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222379|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222380|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222381|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222382|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222383|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222384|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222517|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
222385|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222386|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222387|NCT01300767|E2|Reported Event|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222388|NCT01300767|E1|Reported Event|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
222389|NCT01300741|B1|Baseline|Lotrafilcon B / Galyfilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
222390|NCT01300741|P1|Participant Flow|Lotrafilcon B / Galyfilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
222391|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222392|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222393|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222394|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222395|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222396|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222397|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222398|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222399|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222400|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222401|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222402|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222403|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222404|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222405|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222406|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222407|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222408|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222409|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222410|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222411|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222412|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222413|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222414|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222415|NCT01300741|E2|Reported Event|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
222416|NCT01300741|E1|Reported Event|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
222417|NCT01300728|B3|Baseline|Total|Total of all reporting groups
222418|NCT01300728|B2|Baseline|Saline Solution|"0.9% saline solution
Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
222419|NCT01300728|B1|Baseline|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg
NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.
Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
222420|NCT01300728|P2|Participant Flow|Saline Solution|"0.9% saline solution
Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
222421|NCT01300728|P1|Participant Flow|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg
NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.
Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
222422|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution
Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
222423|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg
NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.
Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
222424|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution
Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
222425|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg
NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.
Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
222426|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution
Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
222427|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg
NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.
Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
222428|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution
Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
222429|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg
NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.
Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
222430|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution
Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
222431|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg
NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.
Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
222432|NCT01300728|E2|Reported Event|Saline Solution|"0.9% saline solution
Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
222433|NCT01300728|E1|Reported Event|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg
NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.
Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
222434|NCT01300650|B1|Baseline|Anakinra|
222435|NCT01300650|P1|Participant Flow|Anakinra|Anakinra 100 mg subcutaneous daily injection
222436|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous injection
222437|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous daily injection
222438|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous daily injection
222439|NCT01300650|E1|Reported Event|Anakinra|
222440|NCT01300624|B1|Baseline|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
222441|NCT01300624|P1|Participant Flow|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
222442|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Verb Network Strengthening Treatment (VNeST) tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced.
Verb Network Strengthening Treatment: Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke."
222443|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
222444|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
222445|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
222446|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
222447|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
222448|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
222449|NCT01300624|E1|Reported Event|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
222450|NCT01300559|B3|Baseline|Total|Total of all reporting groups
222451|NCT01300559|B2|Baseline|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
222452|NCT01300559|B1|Baseline|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
222453|NCT01300559|P2|Participant Flow|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
222454|NCT01300559|P1|Participant Flow|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
222455|NCT01300559|O2|Outcome|No Treatment Group|Unipolar electrocautery without Tissuelink device will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.
222456|NCT01300559|O1|Outcome|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.
222457|NCT01300559|E2|Reported Event|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
222458|NCT01300559|E1|Reported Event|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
222459|NCT01300546|B3|Baseline|Total|Total of all reporting groups
222460|NCT01300546|B2|Baseline|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222518|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
236836|NCT01258387|O1|Outcome|Placebo|
222461|NCT01300546|B1|Baseline|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222462|NCT01300546|P2|Participant Flow|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222463|NCT01300546|P1|Participant Flow|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222464|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222465|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222466|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222467|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222468|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222469|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222470|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222471|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222472|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222473|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222474|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222475|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222476|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222477|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222478|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222479|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222515|NCT01300351|P1|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
222516|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
222480|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222481|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222482|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222483|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222484|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222485|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222486|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222487|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222488|NCT01300546|E2|Reported Event|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
222489|NCT01300546|E1|Reported Event|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
222490|NCT01300455|B3|Baseline|Total|Total of all reporting groups
222491|NCT01300455|B2|Baseline|Placebo Then Suvorexant (40 mg)|Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.
222492|NCT01300455|B1|Baseline|Suvorexant (40 mg) Then Placebo|In Period 1, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
222493|NCT01300455|P2|Participant Flow|Placebo Then Suvorexant (40 mg)|Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.
222494|NCT01300455|P1|Participant Flow|Suvorexant (40 mg) Then Placebo|In Period 1, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
222495|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
222496|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
222497|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
222498|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
222499|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
222500|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
222501|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
222502|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
222503|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
222504|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
222505|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
222506|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
222507|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
222508|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
222509|NCT01300455|E2|Reported Event|Placebo|Participants administered placebo.
222510|NCT01300455|E1|Reported Event|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
222511|NCT01300351|B3|Baseline|Total|Total of all reporting groups
222512|NCT01300351|B2|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
222513|NCT01300351|B1|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
222514|NCT01300351|P2|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
222519|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
222520|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
222521|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
222522|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
222523|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
222524|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
222525|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
222526|NCT01300351|E2|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
222527|NCT01300351|E1|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
222528|NCT01300338|B3|Baseline|Total|Total of all reporting groups
222529|NCT01300338|B2|Baseline|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry
Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
222530|NCT01300338|B1|Baseline|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry
blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
222531|NCT01300338|P2|Participant Flow|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry
Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry."
222532|NCT01300338|P1|Participant Flow|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry
blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
222533|NCT01300338|O2|Outcome|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry
Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
222534|NCT01300338|O1|Outcome|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry
blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
222535|NCT01300338|O2|Outcome|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry
Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
222536|NCT01300338|O1|Outcome|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry
blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
222537|NCT01300338|E2|Reported Event|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry
Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
222538|NCT01300338|E1|Reported Event|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry
blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
222539|NCT01300286|B1|Baseline|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously
222540|NCT01300286|P1|Participant Flow|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
222541|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.
RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
222542|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.
RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
222543|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.
RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
222544|NCT01300286|O1|Outcome|RiaSTAP|One time dose of 70 mg/kg will be administered intravenously.
222545|NCT01300286|O1|Outcome|RiaSTAP|One time dose of 70 mg/kg will be administered intravenously.
222546|NCT01300286|E1|Reported Event|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
222547|NCT01300260|B3|Baseline|Total|Total of all reporting groups
222548|NCT01300260|B2|Baseline|Participants With Type 2 Diabetes Mellitus (T2DM)|Includes participants with T2DM randomized to receive 1.5 mg LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.
222549|NCT01300260|B1|Baseline|Healthy Participants|Includes healthy participants randomized to receive 1.5 milligram (mg) LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.
222550|NCT01300260|P2|Participant Flow|Placebo First, Then LY2189265|"Includes healthy participants and participants with T2DM. Placebo: Single subcutaneous (SC) injection of Placebo on Day 1 of Period 1. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) SC injection on Day 1 of Period 2.
On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes [min]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hr glucose >10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr [mL/hr] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
There was a washout period of ≥28 days between Periods 1 & 2."
222582|NCT01300247|B1|Baseline|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222583|NCT01300247|P2|Participant Flow|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222551|NCT01300260|P1|Participant Flow|LY2189265 First, Then Placebo|"Includes healthy participants or participants with T2DM. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) subcutaneous (SC) injection on Day 1 of Period 1. Placebo: Single SC injection of Placebo on Day 1 of Period 2.
On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes [min]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hr glucose >10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr [mL/hr] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
There was a washout period of ≥28 days between Periods 1 & 2."
222552|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
222553|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
222554|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
222555|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered
222556|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
222557|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
222558|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
222584|NCT01300247|P1|Participant Flow|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 milligrams [mg] intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 milligrams per meter square [mg/m^2] IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222559|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
222560|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222561|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222562|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222563|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222564|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222565|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222566|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222567|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222568|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222569|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes)
222570|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222571|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222572|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222573|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222574|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222575|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
222576|NCT01300260|E4|Reported Event|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265
222577|NCT01300260|E3|Reported Event|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants who received at least 1 subcutaneous injection of Placebo
222578|NCT01300260|E2|Reported Event|Healthy Participants: LY2189265|Healthy participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265
222579|NCT01300260|E1|Reported Event|Healthy Participants: Placebo|Healthy participants who received at least 1 subcutaneous injection of Placebo
222580|NCT01300247|B3|Baseline|Total|Total of all reporting groups
222581|NCT01300247|B2|Baseline|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222585|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222586|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222587|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222588|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222589|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222590|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222591|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222592|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222593|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222594|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222595|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222596|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222597|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222598|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222599|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222600|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222601|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222602|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222630|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
223818|NCT01296646|E2|Reported Event|Naltrexone|50 mg of naltrexone orally daily.
222603|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222604|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222605|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222606|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222607|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222608|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222609|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222610|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222611|NCT01300247|E2|Reported Event|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
222612|NCT01300247|E1|Reported Event|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
222613|NCT01300234|B3|Baseline|Total|Total of all reporting groups
222614|NCT01300234|B2|Baseline|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222615|NCT01300234|B1|Baseline|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222616|NCT01300234|P2|Participant Flow|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222617|NCT01300234|P1|Participant Flow|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222618|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222619|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222620|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222621|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222622|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222623|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222624|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222625|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222626|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222627|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222628|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222629|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
223819|NCT01296646|E1|Reported Event|Placebo|Placebo taken once daily.
222631|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222632|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222633|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222634|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222635|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222636|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222637|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222638|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222639|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222640|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222641|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222642|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222643|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222644|NCT01300234|E2|Reported Event|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
222645|NCT01300234|E1|Reported Event|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
222646|NCT01300052|B3|Baseline|Total|Total of all reporting groups
222647|NCT01300052|B2|Baseline|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222648|NCT01300052|B1|Baseline|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222649|NCT01300052|P2|Participant Flow|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222650|NCT01300052|P1|Participant Flow|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator
222651|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222652|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222653|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222654|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222655|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222656|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222657|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222658|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222659|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222660|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222661|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222662|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
223109|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
222663|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222664|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222665|NCT01300052|E2|Reported Event|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222666|NCT01300052|E1|Reported Event|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
222667|NCT01299961|B1|Baseline|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
222668|NCT01299961|P1|Participant Flow|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
222669|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
222670|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
222671|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
222672|NCT01299961|E1|Reported Event|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
222673|NCT01299909|B4|Baseline|Total|Total of all reporting groups
222674|NCT01299909|B3|Baseline|Quitline|Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
222675|NCT01299909|B2|Baseline|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
222676|NCT01299909|B1|Baseline|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
222677|NCT01299909|P3|Participant Flow|Quitline|Non-Randomized, Treatment as Usual condition; participants self-selected to this group and received smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL).
222678|NCT01299909|P2|Participant Flow|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
222679|NCT01299909|P1|Participant Flow|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
222680|NCT01299909|O2|Outcome|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
222681|NCT01299909|O1|Outcome|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
222682|NCT01299909|E3|Reported Event|Quitline|Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
222683|NCT01299909|E2|Reported Event|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.
Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
222684|NCT01299909|E1|Reported Event|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.
Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
222685|NCT01299896|B3|Baseline|Total|Total of all reporting groups
222686|NCT01299896|B2|Baseline|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.
Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
222687|NCT01299896|B1|Baseline|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.
Usual Care: Standard therapy to help participants with smoking cessation."
222688|NCT01299896|P2|Participant Flow|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.
Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
222689|NCT01299896|P1|Participant Flow|Usual Care|"Participants will continue to receive all the care currently offered in the Veterans Administration Pittsburgh Healthcare System (VAPHS), including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.
Usual Care: Standard therapy to help participants with smoking cessation."
222690|NCT01299896|O2|Outcome|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.
Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
222691|NCT01299896|O1|Outcome|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.
Usual Care: Standard therapy to help participants with smoking cessation."
222692|NCT01299896|E2|Reported Event|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.
Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
222693|NCT01299896|E1|Reported Event|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.
Usual Care: Standard therapy to help participants with smoking cessation."
222694|NCT01299805|B3|Baseline|Total|Total of all reporting groups
222695|NCT01299805|B2|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222696|NCT01299805|B1|Baseline|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222697|NCT01299805|P2|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222698|NCT01299805|P1|Participant Flow|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222699|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222700|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222701|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222702|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222703|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222704|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222705|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222706|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222707|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222708|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222709|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222710|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222711|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222712|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222713|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222714|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222715|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222716|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222717|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222718|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222719|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222720|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222721|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222722|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222723|NCT01299805|E2|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
222724|NCT01299805|E1|Reported Event|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
222725|NCT01299584|B1|Baseline|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
222726|NCT01299584|P1|Participant Flow|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
222727|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
222728|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
222729|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
222769|NCT01299480|O1|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
222730|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
222731|NCT01299584|E1|Reported Event|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
222732|NCT01299571|B1|Baseline|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
222733|NCT01299571|P1|Participant Flow|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily.
222734|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
222735|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
222736|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
222737|NCT01299571|E1|Reported Event|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
222738|NCT01299480|B6|Baseline|Total|Total of all reporting groups
222739|NCT01299480|B5|Baseline|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
222740|NCT01299480|B4|Baseline|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
222741|NCT01299480|B3|Baseline|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
222742|NCT01299480|B2|Baseline|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
222743|NCT01299480|B1|Baseline|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
222744|NCT01299480|P5|Participant Flow|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
222745|NCT01299480|P4|Participant Flow|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
222746|NCT01299480|P3|Participant Flow|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
222747|NCT01299480|P2|Participant Flow|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
222748|NCT01299480|P1|Participant Flow|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
222749|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
222750|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
222751|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
222752|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
222753|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
222754|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
222755|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
222756|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
222757|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
222758|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
222759|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
222760|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
222761|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
222762|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
222763|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
222764|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
222765|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
222766|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
222767|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
222768|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
223820|NCT01296412|B3|Baseline|Total|Total of all reporting groups
222770|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
222771|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
222772|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
222773|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
222774|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
222775|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
222776|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
222777|NCT01299480|E5|Reported Event|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
222778|NCT01299480|E4|Reported Event|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
222779|NCT01299480|E3|Reported Event|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
222780|NCT01299480|E2|Reported Event|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
222781|NCT01299480|E1|Reported Event|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
222782|NCT01299454|B5|Baseline|Total|Total of all reporting groups
222783|NCT01299454|B4|Baseline|Normal Hepatic Function|Participants with normal hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222784|NCT01299454|B3|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222785|NCT01299454|B2|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222786|NCT01299454|B1|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222787|NCT01299454|P4|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.
222788|NCT01299454|P3|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.
222789|NCT01299454|P2|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme)received a single dose of oral brexpiprazole 2 mg.
222790|NCT01299454|P1|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 milligrams (mg).
222791|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222792|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222793|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222794|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222795|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222796|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222797|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222798|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222799|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222800|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222801|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222802|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222803|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222804|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222805|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222806|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222807|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
223936|NCT01295814|E1|Reported Event|Inactive Drug|inactive drug : placebo
222808|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222809|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222810|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222811|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222812|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222813|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222814|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222815|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222816|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222817|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222818|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222819|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222820|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg
222821|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222822|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222823|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222824|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222825|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
222826|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222827|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222828|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222829|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222830|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
223100|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
222831|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222832|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222833|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222834|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222835|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222836|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222837|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222838|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222839|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222840|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222841|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222842|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222843|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
222844|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222845|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222846|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222847|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222848|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222849|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222850|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222851|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222852|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
223937|NCT01295281|B3|Baseline|Total|Total of all reporting groups
222853|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222854|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222855|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222856|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222857|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222858|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222859|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222860|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222861|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222862|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222863|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222864|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222865|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222866|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222867|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222868|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222869|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222870|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222871|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222872|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222873|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222874|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222875|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222876|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222877|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
222878|NCT01299454|O5|Outcome|Sever Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222879|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222880|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222881|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222882|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222883|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
222884|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222885|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
222886|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222887|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222888|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222889|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222890|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222891|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222892|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222893|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222894|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222895|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222896|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222897|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222898|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222899|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participants with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Partipants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222900|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222901|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222902|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222903|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222904|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222905|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222906|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222907|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222908|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222909|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222910|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222911|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222912|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222913|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant ith hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222914|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222915|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222916|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222917|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participant with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
223101|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
222918|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222919|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a particpant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222920|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with normal hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222921|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222922|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222923|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222924|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222925|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
222926|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222927|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222928|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222929|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222930|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222931|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
222932|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222933|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222934|NCT01299454|O3|Outcome|Moderate Hepatic Impairment.|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222935|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222936|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg
222937|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222938|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222939|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222940|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222941|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.
Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
222942|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222943|NCT01299454|E4|Reported Event|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222944|NCT01299454|E3|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222945|NCT01299454|E2|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222946|NCT01299454|E1|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
222947|NCT01299389|B3|Baseline|Total|Total of all reporting groups
222948|NCT01299389|B2|Baseline|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
222949|NCT01299389|B1|Baseline|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
222950|NCT01299389|P4|Participant Flow|Paliperidone Palmitate (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
222951|NCT01299389|P3|Participant Flow|Placebo (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
222952|NCT01299389|P2|Participant Flow|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
222953|NCT01299389|P1|Participant Flow|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
222954|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
222955|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
222956|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
222957|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
222958|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
222959|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
222960|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
222961|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
222962|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
222963|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
222964|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
222965|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
222966|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
222967|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularl (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
222968|NCT01299389|E4|Reported Event|Paliperidone Palmitate (Post-0bservational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
224305|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
222969|NCT01299389|E3|Reported Event|Placebo (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
222970|NCT01299389|E2|Reported Event|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
222971|NCT01299389|E1|Reported Event|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
222972|NCT01299376|B3|Baseline|Total|Total of all reporting groups
222973|NCT01299376|B2|Baseline|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222974|NCT01299376|B1|Baseline|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222975|NCT01299376|P2|Participant Flow|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222976|NCT01299376|P1|Participant Flow|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222977|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
222978|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
222979|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222980|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222981|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222982|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222983|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222984|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222985|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222986|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222987|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222988|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
222989|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
222990|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
222991|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
222992|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
222993|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
222994|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
222995|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
222996|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
222997|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
222998|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
222999|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
223000|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
223001|NCT01299376|E4|Reported Event|L50/H12.5→L50/H12.5/A5 - Extension|Participants who received L50/H12.5 combination tablet in double-blind treatment period and then received L50/H12.5/A5 orally once daily for 44 weeks in extension period.
223002|NCT01299376|E3|Reported Event|L50/H12.5/A5→L50/H12.5/A5 - Extension|Participants who received L50/H12.5/A5 combination tablet in double-blind treatment period and continued to receive L50/H12.5/A5 orally once daily for 44 weeks in extension period.
223003|NCT01299376|E2|Reported Event|L50/H12.5/A5 - Double Blind Treatment Period|Participants received L50/H12.5/A5 combination tablet, orally once daily for 8 weeks
223004|NCT01299376|E1|Reported Event|L50/H12.5- Double Blind Treatment Period|Participants received L50/H12.5 combination tablet, orally once daily for 8 weeks
223005|NCT01299285|B1|Baseline|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223006|NCT01299285|P1|Participant Flow|LY3009104 (Baricitinib)|Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104
223007|NCT01299285|O2|Outcome|LY3009104 Metabolites|The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223008|NCT01299285|O1|Outcome|LY3009104|The percentage of total radioactivity of LY3009104 (parent) in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223009|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223010|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223011|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223012|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223013|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223014|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223015|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223016|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223017|NCT01299285|E1|Reported Event|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
223018|NCT01299103|B4|Baseline|Total|Total of all reporting groups
223019|NCT01299103|B3|Baseline|Triple Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
223020|NCT01299103|B2|Baseline|Double Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
223021|NCT01299103|B1|Baseline|Single Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
223022|NCT01299103|P3|Participant Flow|Triple Treatment|Subjects receive three treatments
223023|NCT01299103|P2|Participant Flow|Double Treatment|Subjects receive two treatments
223024|NCT01299103|P1|Participant Flow|Single Treatment|Subjects receive one treatment
223025|NCT01299103|O3|Outcome|Triple Treatment|Subjects receive three treatments
223026|NCT01299103|O2|Outcome|Double Treatment|Subjects receive two treatments
223027|NCT01299103|O1|Outcome|Single Treatment|Subjects receive one treatment
223028|NCT01299103|O3|Outcome|Triple Treatment|Subjects receive three treatments
223029|NCT01299103|O2|Outcome|Double Treatment|Subjects receive two treatments
223030|NCT01299103|O1|Outcome|Single Treatment|Subjects receive one treatment
223031|NCT01299103|E3|Reported Event|Triple Treatment|Subjects receive three treatments
223032|NCT01299103|E2|Reported Event|Double Treatment|Subjects receive two treatments
223033|NCT01299103|E1|Reported Event|Single Treatment|Subjects receive one treatment
223034|NCT01299090|B1|Baseline|Treatment Group|"All subjects enrolled were in the treatment group.
Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
223035|NCT01299090|P1|Participant Flow|Treatment Group|"All subjects enrolled were in the treatment group.
Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
223036|NCT01299090|O1|Outcome|Treatment Group|"All subjects enrolled were in the treatment group.
Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
223037|NCT01299090|O1|Outcome|Treatment Group|"All subjects enrolled were in the treatment group.
Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
223038|NCT01299090|E1|Reported Event|Treatment Group|"All subjects enrolled were in the treatment group.
Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
223039|NCT01299077|B1|Baseline|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:
NSAID (diclofenac) 75 mg,: twice daily for two weeks"
223040|NCT01299077|P1|Participant Flow|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:
NSAID (diclofenac) 75 mg,: twice daily for two weeks"
223041|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:
NSAID (diclofenac) 75 mg,: twice daily for two weeks"
223102|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223103|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223042|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:
NSAID (diclofenac) 75 mg,: twice daily for two weeks"
223043|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:
NSAID (diclofenac) 75 mg,: twice daily for two weeks"
223044|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:
NSAID (diclofenac) 75 mg,: twice daily for two weeks"
223045|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:
NSAID (diclofenac) 75 mg,: twice daily for two weeks"
223046|NCT01299077|E1|Reported Event|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:
NSAID (diclofenac) 75 mg,: twice daily for two weeks"
223047|NCT01299025|B3|Baseline|Total|Total of all reporting groups
223048|NCT01299025|B2|Baseline|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
223049|NCT01299025|B1|Baseline|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
223050|NCT01299025|P2|Participant Flow|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
223051|NCT01299025|P1|Participant Flow|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
223052|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
223053|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
223054|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
223055|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
223056|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
223057|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
223058|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
223059|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
223060|NCT01299025|E2|Reported Event|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week
Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
223061|NCT01299025|E1|Reported Event|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
223062|NCT01298778|B3|Baseline|Total|Total of all reporting groups
223063|NCT01298778|B2|Baseline|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
223064|NCT01298778|B1|Baseline|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
223065|NCT01298778|P2|Participant Flow|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
223066|NCT01298778|P1|Participant Flow|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
223067|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
223068|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
223069|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
223104|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223105|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223070|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
223071|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
223072|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
223073|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Duramorph 300: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
223074|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph 150: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
223075|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
223076|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
223077|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
223078|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
223079|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
223080|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
223081|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
223082|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
223083|NCT01298778|E2|Reported Event|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
223084|NCT01298778|E1|Reported Event|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
223085|NCT01298661|B4|Baseline|Total|Total of all reporting groups
223086|NCT01298661|B3|Baseline|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223087|NCT01298661|B2|Baseline|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223088|NCT01298661|B1|Baseline|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223089|NCT01298661|P3|Participant Flow|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223090|NCT01298661|P2|Participant Flow|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223091|NCT01298661|P1|Participant Flow|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223092|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223093|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223094|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223095|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223096|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223097|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223098|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223099|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223111|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223112|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223113|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223114|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223115|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223116|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223117|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223118|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223119|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223120|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223121|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223122|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223123|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223124|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223125|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223126|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223127|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223128|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223129|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223130|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223131|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223132|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223133|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223134|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223135|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223136|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223137|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223138|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223139|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223140|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223141|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223142|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223143|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223144|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223145|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223146|NCT01298661|O1|Outcome|COPD Patients|Patients with clinical and spirometrical diagnosis of Chronic Obstructive Pulmonary Disease
223147|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223148|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223149|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223150|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223151|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223152|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223153|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223154|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223155|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223156|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223157|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223158|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223159|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223160|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223161|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223162|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223163|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223164|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
223165|NCT01298661|E3|Reported Event|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
223166|NCT01298661|E2|Reported Event|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
223167|NCT01298661|E1|Reported Event|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
224043|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
223168|NCT01298648|B1|Baseline|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
223169|NCT01298648|P1|Participant Flow|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
223170|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
223171|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
223172|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
223173|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
223174|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
223175|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
223176|NCT01298648|E1|Reported Event|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
223177|NCT01298544|B1|Baseline|Entire Study Population|All randomized participants
223178|NCT01298544|P1|Participant Flow|Entire Study Population|All randomized participants
223179|NCT01298544|O3|Outcome|DTaP Alone|No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).
223180|NCT01298544|O2|Outcome|7vPnC and DTaP|No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
223181|NCT01298544|O1|Outcome|7vPnC|No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
223182|NCT01298544|O3|Outcome|DTaP Alone|No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).
223183|NCT01298544|O2|Outcome|7vPnC and DTaP|No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
223184|NCT01298544|O1|Outcome|7vPnC|No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
223185|NCT01298544|E1|Reported Event|Entire Study Population|All randomized participants
223186|NCT01298531|B3|Baseline|Total|Total of all reporting groups
223187|NCT01298531|B2|Baseline|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223188|NCT01298531|B1|Baseline|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223189|NCT01298531|P2|Participant Flow|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223190|NCT01298531|P1|Participant Flow|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223191|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223192|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223193|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223194|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223195|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223196|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223197|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223198|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223199|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223200|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223201|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223202|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223203|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
224045|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
223204|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223205|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223206|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223207|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223208|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223209|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223210|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223211|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223212|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223213|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223214|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223215|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223216|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223217|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223218|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223219|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223220|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223221|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223222|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223223|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223224|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223225|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223226|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223227|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223228|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223229|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223230|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223231|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223232|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223233|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223234|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223235|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223236|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223237|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223238|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223486|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223239|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223240|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223241|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223242|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223243|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223244|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223245|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223246|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223247|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223248|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223249|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223250|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223251|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223252|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223253|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223254|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223255|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223256|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223257|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223258|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223259|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223260|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223261|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223262|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223263|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223264|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223265|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223266|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223267|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223268|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223269|NCT01298531|O1|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223270|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223271|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223272|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223273|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
224046|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
223274|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223275|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223276|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223277|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223278|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223279|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223280|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223281|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223282|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223283|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223284|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223285|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223286|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223287|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223288|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223289|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223290|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223291|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223292|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223293|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223294|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223295|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223296|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223297|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223298|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223299|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223300|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223301|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223302|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223303|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223304|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223305|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223306|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223307|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223308|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223487|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223309|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223310|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223311|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223312|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223313|NCT01298531|E2|Reported Event|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
223314|NCT01298531|E1|Reported Event|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
223315|NCT01298518|B4|Baseline|Total|Total of all reporting groups
223316|NCT01298518|B3|Baseline|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223317|NCT01298518|B2|Baseline|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223318|NCT01298518|B1|Baseline|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223319|NCT01298518|P3|Participant Flow|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223320|NCT01298518|P2|Participant Flow|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223321|NCT01298518|P1|Participant Flow|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223322|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223323|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223324|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223325|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223326|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223327|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223328|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223329|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223330|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223331|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223332|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223333|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223334|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223335|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223336|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223337|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223338|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223339|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223340|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223341|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223342|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223343|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223445|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
223344|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223345|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223346|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223347|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223348|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223349|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223350|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223351|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223352|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223353|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223354|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223355|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223356|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223357|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223358|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223359|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223360|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223361|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223362|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223363|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223364|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223365|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223366|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223367|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223368|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223369|NCT01298518|E3|Reported Event|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
223370|NCT01298518|E2|Reported Event|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
223371|NCT01298518|E1|Reported Event|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
223372|NCT01298492|B1|Baseline|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
223373|NCT01298492|P1|Participant Flow|PF-00547659 75 mg|Participants received PF-00547659 75 milligram (mg) subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
223374|NCT01298492|O1|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
223529|NCT01297504|O1|Outcome|LTRI|Hospitalizations due to lower respiratory tract infections (LRTI).
223375|NCT01298492|O1|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
223376|NCT01298492|O1|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
223377|NCT01298492|E1|Reported Event|PF-00547659 75 mg|Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
223378|NCT01298362|B3|Baseline|Total|Total of all reporting groups
223379|NCT01298362|B2|Baseline|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
223380|NCT01298362|B1|Baseline|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
223381|NCT01298362|P2|Participant Flow|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
223382|NCT01298362|P1|Participant Flow|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
223383|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
223384|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
223385|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
223386|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
223387|NCT01298362|O2|Outcome|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
223388|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
223389|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
223390|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
223391|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
223392|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
223393|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
223394|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
223395|NCT01298362|O2|Outcome|HT Cohort|"In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
The primary outcome variable was the mean percentage change in LS BMD between the pre CT treatment measurement and the post 12 months AI measurements in the CT cohort. The HT cohort was included as a control group.
BMD measurements in HT cohort were taken before AI start and at 12 months."
223396|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
223397|NCT01298362|E2|Reported Event|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
223398|NCT01298362|E1|Reported Event|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
223399|NCT01298323|B3|Baseline|Total|Total of all reporting groups
223400|NCT01298323|B2|Baseline|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
223401|NCT01298323|B1|Baseline|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
223402|NCT01298323|P2|Participant Flow|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
223403|NCT01298323|P1|Participant Flow|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
223404|NCT01298323|O2|Outcome|Vandetanib 300 mg|Patients on this arm will get a standard AE monitoring schedule, similar to that used on previous studies. Patients will be asked about any AEs at scheduled visits and will have the option to contact the investigator at any time if experiencing any AE or symptoms and discuss the best treatment options.
223446|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
224563|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
223405|NCT01298323|O1|Outcome|Vandetanib 300 mg+Outreach Program|Patients on this arm will be contacted by site personnel at week 1 and then every 2 weeks during the first 52 weeks on the study (or prior discontinuation) to detect and possibly treat adverse events sooner than they might have been without the patient outreach, and at a time of lesser CTCAE grade.
223406|NCT01298323|E2|Reported Event|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
223407|NCT01298323|E1|Reported Event|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
223408|NCT01298167|B3|Baseline|Total|Total of all reporting groups
223409|NCT01298167|B2|Baseline|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
223410|NCT01298167|B1|Baseline|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
223411|NCT01298167|P2|Participant Flow|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
223412|NCT01298167|P1|Participant Flow|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
223413|NCT01298167|O2|Outcome|FAG Superior/Inferior|Combined measures of Fast Absorbing Gut Suture used on both the superior and inferior halves of wounds.
223414|NCT01298167|O1|Outcome|Cyanoacrylate Superior/Inferior|Combined measures of Cyanoacrylate used on both the superior and inferior halves of wounds.
223415|NCT01298167|E2|Reported Event|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
223416|NCT01298167|E1|Reported Event|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
223417|NCT01298128|B3|Baseline|Total|Total of all reporting groups
223418|NCT01298128|B2|Baseline|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
223419|NCT01298128|B1|Baseline|NuvaRing|NuvaRing for IVF pre-treatment
223420|NCT01298128|P2|Participant Flow|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
223421|NCT01298128|P1|Participant Flow|NuvaRing|NuvaRing for IVF pre-treatment
223422|NCT01298128|O2|Outcome|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
223423|NCT01298128|O1|Outcome|NuvaRing|NuvaRing for IVF pre-treatment
223424|NCT01298128|E2|Reported Event|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
223425|NCT01298128|E1|Reported Event|NuvaRing|NuvaRing for IVF pre-treatment
223426|NCT01298063|B6|Baseline|Total|Total of all reporting groups
223427|NCT01298063|B5|Baseline|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
223428|NCT01298063|B4|Baseline|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
223429|NCT01298063|B3|Baseline|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
223430|NCT01298063|B2|Baseline|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
223431|NCT01298063|B1|Baseline|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
223432|NCT01298063|P5|Participant Flow|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
223433|NCT01298063|P4|Participant Flow|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
223434|NCT01298063|P3|Participant Flow|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
223435|NCT01298063|P2|Participant Flow|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
223436|NCT01298063|P1|Participant Flow|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 milligram (mg) Afatinib (One tablet qd in the morning).
223437|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
223438|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
223439|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
223440|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
223441|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
223442|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
223443|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
223444|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
224128|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
223447|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
223448|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
223449|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
223450|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
223451|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
223452|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
223453|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
223454|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
223455|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
223456|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 milligram (mg) Afatinib (One tablet qd in the morning).
223457|NCT01298063|E5|Reported Event|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
223458|NCT01298063|E4|Reported Event|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
223459|NCT01298063|E3|Reported Event|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
223460|NCT01298063|E2|Reported Event|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
223461|NCT01298063|E1|Reported Event|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
223462|NCT01297920|B4|Baseline|Total|Total of all reporting groups
223463|NCT01297920|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
223464|NCT01297920|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
223465|NCT01297920|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
223466|NCT01297920|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
223467|NCT01297920|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
223468|NCT01297920|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
223469|NCT01297920|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
223470|NCT01297920|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
223471|NCT01297920|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
223472|NCT01297920|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
223473|NCT01297920|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
223474|NCT01297920|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
223475|NCT01297595|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 250 mg FC first and crizotinib 250 mg OLF first.
223476|NCT01297595|P2|Participant Flow|Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg OLF in first intervention period; and single oral dose of crizotinib 250 mg FC in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
223477|NCT01297595|P1|Participant Flow|Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 milligram (mg) formulated capsule (FC) in first intervention period; and single oral dose of crizotinib 250 mg oral liquid formulation (OLF) in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
223478|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223479|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223480|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223481|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223482|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223483|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223484|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223485|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223488|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223489|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223490|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223491|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223492|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223493|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223494|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223495|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223496|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223497|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223498|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223499|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223500|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223501|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223502|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223503|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223504|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223505|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223506|NCT01297595|E2|Reported Event|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
223507|NCT01297595|E1|Reported Event|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
223508|NCT01297517|B4|Baseline|Total|Total of all reporting groups
223509|NCT01297517|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223510|NCT01297517|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223511|NCT01297517|B1|Baseline|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223512|NCT01297517|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223513|NCT01297517|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223514|NCT01297517|P1|Participant Flow|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223515|NCT01297517|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223516|NCT01297517|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223517|NCT01297517|O1|Outcome|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223518|NCT01297517|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223519|NCT01297517|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223520|NCT01297517|E1|Reported Event|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
223521|NCT01297504|B1|Baseline|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
223522|NCT01297504|P1|Participant Flow|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
223523|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
223524|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
223525|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
223526|NCT01297504|O2|Outcome|Multivariate|
223527|NCT01297504|O1|Outcome|Univariate|
223528|NCT01297504|O2|Outcome|LTRI Due to RSV|Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
223530|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
223531|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
223532|NCT01297504|E1|Reported Event|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
223533|NCT01297491|B3|Baseline|Total|Total of all reporting groups
223534|NCT01297491|B2|Baseline|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
223535|NCT01297491|B1|Baseline|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
223536|NCT01297491|P2|Participant Flow|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
223537|NCT01297491|P1|Participant Flow|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
223538|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
223539|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
223540|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
223541|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
223542|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
223543|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
223544|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
223545|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
223546|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
223547|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
223548|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
223549|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
223550|NCT01297491|E2|Reported Event|Non-Squamous BKM120 100 mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
223551|NCT01297491|E1|Reported Event|Squamous BKM120 100 mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
223552|NCT01297465|B3|Baseline|Total|Total of all reporting groups
223553|NCT01297465|B2|Baseline|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223554|NCT01297465|B1|Baseline|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223555|NCT01297465|P2|Participant Flow|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223556|NCT01297465|P1|Participant Flow|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223557|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223558|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223559|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223560|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223561|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223562|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223563|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223564|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223565|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223566|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223567|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223568|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223569|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223603|NCT01297335|O1|Outcome|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
clonidine: Intrathecal Clonidine"
224306|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
223570|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223571|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223572|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223573|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223574|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223575|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223576|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223577|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223578|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223579|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223580|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223581|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223604|NCT01297335|O1|Outcome|Intrathecal Clonidine|Subject received one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg were delivered. Supine and sitting blood pressures and heart rate were measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
223747|NCT01296763|O1|Outcome|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Olaparib 100 mg bid oral, Days 1 and 8"
223582|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223583|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223584|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223585|NCT01297465|E2|Reported Event|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
223586|NCT01297465|E1|Reported Event|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
223587|NCT01297348|B3|Baseline|Total|Total of all reporting groups
223588|NCT01297348|B2|Baseline|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
223589|NCT01297348|B1|Baseline|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
223590|NCT01297348|P2|Participant Flow|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
223591|NCT01297348|P1|Participant Flow|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
223592|NCT01297348|O3|Outcome|Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20)|A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed.
223593|NCT01297348|O2|Outcome|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
223594|NCT01297348|O1|Outcome|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
223595|NCT01297348|O3|Outcome|Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20)|A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed.
223596|NCT01297348|O2|Outcome|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
223597|NCT01297348|O1|Outcome|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
223598|NCT01297348|E2|Reported Event|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
223599|NCT01297348|E1|Reported Event|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
223600|NCT01297335|B1|Baseline|Intrathecal Clonidine|All subjects met all inclusion and exclusionary criteria, and we report study subjects' demographic information in following sections.
223601|NCT01297335|P1|Participant Flow|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
clonidine: Intrathecal Clonidine"
223602|NCT01297335|O1|Outcome|Intrathecal Clonidine|Subjects were asked to rate both level of sedation and dryness of their mouths (two of the most common side effects of clonidine) at before clonidine injection (baseline) and at one hour after clonidine injection (Post injection) on VAS scale. VAS scale is an analogue scale that measures subject response from 0 to 10 cm, where larger value represents greater level of sedation and dryness in the mouth subject experienced.
223742|NCT01296763|P3|Participant Flow|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Mitomycin 5 mg/m2 IV, Day 1
Olaparib 100 mg bid oral, Days 1 and 8"
223605|NCT01297335|E1|Reported Event|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
clonidine: Intrathecal Clonidine"
223606|NCT01297322|B3|Baseline|Total|Total of all reporting groups
223607|NCT01297322|B2|Baseline|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
223608|NCT01297322|B1|Baseline|Manual Compression|Manual compression: Standard of Care
223609|NCT01297322|P2|Participant Flow|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
223610|NCT01297322|P1|Participant Flow|Manual Compression|Manual compression: Standard of Care
223611|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
223612|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
223613|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
223614|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
223615|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
223616|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
223617|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
223618|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
223619|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
223620|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
223621|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
223622|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
223623|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
223624|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
223625|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
223626|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
223627|NCT01297322|E2|Reported Event|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
223628|NCT01297322|E1|Reported Event|Manual Compression|Manual compression: Standard of Care
223629|NCT01297283|B1|Baseline|Overall Subjects|
223630|NCT01297283|P1|Participant Flow|Overall Subjects|Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device
223631|NCT01297283|O1|Outcome|Overall Subjects|
223632|NCT01297283|O1|Outcome|Overall Subjects|
223633|NCT01297283|E1|Reported Event|Overall Subjects|
223634|NCT01297270|B4|Baseline|Total|Total of all reporting groups
223635|NCT01297270|B3|Baseline|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223636|NCT01297270|B2|Baseline|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223637|NCT01297270|B1|Baseline|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223638|NCT01297270|P3|Participant Flow|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223639|NCT01297270|P2|Participant Flow|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223640|NCT01297270|P1|Participant Flow|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir (BI 201335) 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223641|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223642|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223643|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223644|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223743|NCT01296763|P2|Participant Flow|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Olaparib 100mg bid oral, Day 1-3, Day 8-10"
223814|NCT01296646|O2|Outcome|Naltrexone|50 mg of naltrexone orally daily.
223645|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223646|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223647|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223648|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223649|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223650|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223651|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223652|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223653|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223654|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223655|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223656|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223657|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223658|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223659|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223660|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223661|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223662|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223663|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223664|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223665|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223666|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223667|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223668|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223744|NCT01296763|P1|Participant Flow|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Olaparib 100 mg bid oral, Days 1 and 8"
223669|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223670|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223671|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223672|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223673|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223674|NCT01297270|E3|Reported Event|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
223675|NCT01297270|E2|Reported Event|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223676|NCT01297270|E1|Reported Event|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
223677|NCT01297257|B1|Baseline|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
223678|NCT01297257|P1|Participant Flow|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
223679|NCT01297257|O1|Outcome|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
223680|NCT01297257|O1|Outcome|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7,740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 10,733 Resolute Integrity™ Stents
223681|NCT01297257|E1|Reported Event|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
223682|NCT01297062|B7|Baseline|Total|Total of all reporting groups
223683|NCT01297062|B6|Baseline|Exenatide-Placebo-Moxifloxacin Sequence|Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III
223684|NCT01297062|B5|Baseline|Placebo-Moxifloxacin-Exenatiden Sequence|Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III
223685|NCT01297062|B4|Baseline|Moxifloxacin-Exenatide-Placebo Sequence|Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III
223686|NCT01297062|B3|Baseline|Moxifloxacin-Placebo-Exenatide Sequence|Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III
223687|NCT01297062|B2|Baseline|Exenatide-Moxifloxacin-Placebo Sequence|Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III
223688|NCT01297062|B1|Baseline|Placebo-Exenatide-Moxifloxacin Sequence|Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III
223689|NCT01297062|P7|Participant Flow|Non-Randomized|Not Randomized
223690|NCT01297062|P6|Participant Flow|Exenatide-Placebo-Moxifloxacin Sequence|"Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III
Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)
Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2
Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
223691|NCT01297062|P5|Participant Flow|Placebo-Moxifloxacin-Exenatiden Sequence|"Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III
Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)
Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2
Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
223692|NCT01297062|P4|Participant Flow|Moxifloxacin-Exenatide-Placebo Sequence|"Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III
Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)
Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2
Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
223745|NCT01296763|O3|Outcome|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Mitomycin 5 mg/m2 IV, Day 1
Olaparib 100 mg bid oral, Days 1 and 8"
223746|NCT01296763|O2|Outcome|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Olaparib 100mg bid oral, Day 1-3, Day 8-10"
223693|NCT01297062|P3|Participant Flow|Moxifloxacin-Placebo-Exenatide Sequence|"Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III
Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)
Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2
Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
223694|NCT01297062|P2|Participant Flow|Exenatide-Moxifloxacin-Placebo Sequence|"Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III
Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)
Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2
Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
223695|NCT01297062|P1|Participant Flow|Placebo-Exenatide-Moxifloxacin Sequence|"Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III;
Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)
Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2
Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
223696|NCT01297062|O1|Outcome|Exenatide|Exenatide
223697|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
223698|NCT01297062|O1|Outcome|Exenatide|Exenatide
223699|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
223700|NCT01297062|O1|Outcome|Exenatide|Exenatide
223701|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
223702|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
223703|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
223704|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
223705|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
223706|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
223707|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
223708|NCT01297062|O1|Outcome|Exenatide|Exenatide
223709|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
223710|NCT01297062|O1|Outcome|Exenatide|Exenatide
223711|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
223712|NCT01297062|O1|Outcome|Exenatide|Exenatide
223713|NCT01297062|E3|Reported Event|Moxifloxacin|Moxifloxacin with placebo infusion
223714|NCT01297062|E2|Reported Event|Placebo|Placebo Comparator
223715|NCT01297062|E1|Reported Event|Exenatide|Exenatide
223716|NCT01296841|B3|Baseline|Total|Total of all reporting groups
223717|NCT01296841|B2|Baseline|Telemedicine Encounter|Remote clinical appointment between patient and physician.
223718|NCT01296841|B1|Baseline|Standard Encounter|"Standard in-house clinical visit between patient and physician."
223719|NCT01296841|P2|Participant Flow|Telemedicine Encounter|Remote clinical appointment between patient and physician.
223720|NCT01296841|P1|Participant Flow|Standard Encounter|"Standard in-house clinical visit between patient and physician."
223721|NCT01296841|O2|Outcome|Telemedicine Encounter|Remote clinical appointment between patient and physician.
223722|NCT01296841|O1|Outcome|Standard Encounter|"Standard in-house clinical visit between patient and physician."
223723|NCT01296841|O2|Outcome|Telemedicine Encounter|Remote clinical appointment between patient and physician.
223724|NCT01296841|O1|Outcome|Standard Encounter|"Standard in-house clinical visit between patient and physician."
223725|NCT01296841|O2|Outcome|Standard|clinic experience (mean±SD)
223726|NCT01296841|O1|Outcome|Telemedicine|clinic experience (mean ± SD, 1 excellent, 5 poor)
223727|NCT01296841|E2|Reported Event|Telemedicine Encounter|Remote clinical appointment between patient and physician.
223728|NCT01296841|E1|Reported Event|Standard Encounter|"Standard in-house clinical visit between patient and physician."
223729|NCT01296815|B3|Baseline|Total|Total of all reporting groups
223730|NCT01296815|B2|Baseline|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
223731|NCT01296815|B1|Baseline|HAART|Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
223732|NCT01296815|P2|Participant Flow|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
223733|NCT01296815|P1|Participant Flow|HAART|Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
223734|NCT01296815|O2|Outcome|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
223735|NCT01296815|O1|Outcome|HAART|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
223736|NCT01296815|E2|Reported Event|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
223737|NCT01296815|E1|Reported Event|HAART|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
223738|NCT01296763|B4|Baseline|Total|Total of all reporting groups
223739|NCT01296763|B3|Baseline|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Mitomycin 5 mg/m2 IV, Day 1
Olaparib 100 mg bid oral, Days 1 and 8"
223740|NCT01296763|B2|Baseline|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Olaparib 100mg bid oral, Day 1-3, Day 8-10"
223741|NCT01296763|B1|Baseline|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Olaparib 100 mg bid oral, Days 1 and 8"
223748|NCT01296763|O3|Outcome|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Mitomycin 5 mg/m2 IV, Day 1
Olaparib 100 mg bid oral, Days 1 and 8"
223749|NCT01296763|O2|Outcome|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Olaparib 100mg bid oral, Day 1-3, Day 8-10"
223750|NCT01296763|O1|Outcome|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Olaparib 100 mg bid oral, Days 1 and 8"
223751|NCT01296763|E3|Reported Event|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Mitomycin 5 mg/m2 IV, Day 1
Olaparib 100 mg bid oral, Days 1 and 8"
223752|NCT01296763|E2|Reported Event|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Olaparib 100mg bid oral, Day 1-3, Day 8-10"
223753|NCT01296763|E1|Reported Event|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatin 25 mg/m2 IV, Days 1 and 8
Olaparib 100 mg bid oral, Days 1 and 8"
223754|NCT01296698|B3|Baseline|Total|Total of all reporting groups
223755|NCT01296698|B2|Baseline|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223756|NCT01296698|B1|Baseline|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223757|NCT01296698|P2|Participant Flow|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223758|NCT01296698|P1|Participant Flow|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223759|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223760|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223761|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223762|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223763|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223764|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223765|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223766|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223767|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223768|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223769|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223770|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223771|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223772|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223773|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223774|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223775|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223776|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223777|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223778|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223779|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223780|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223781|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223782|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223783|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223784|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223785|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223786|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223787|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223788|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223789|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223790|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223791|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223792|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223793|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223794|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223795|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223796|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223797|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223798|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223799|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223800|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223801|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223802|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223803|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223804|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223805|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223806|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223807|NCT01296698|E2|Reported Event|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
223808|NCT01296698|E1|Reported Event|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
223809|NCT01296646|B3|Baseline|Total|Total of all reporting groups
223810|NCT01296646|B2|Baseline|Naltrexone|50 mg of naltrexone orally daily.
223811|NCT01296646|B1|Baseline|Placebo|Placebo taken once daily.
223812|NCT01296646|P2|Participant Flow|Naltrexone|50 mg of naltrexone orally daily.
223813|NCT01296646|P1|Participant Flow|Placebo|Placebo taken once daily.
223821|NCT01296412|B2|Baseline|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
223822|NCT01296412|B1|Baseline|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
223823|NCT01296412|P2|Participant Flow|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
223824|NCT01296412|P1|Participant Flow|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
223825|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
223826|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
223827|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
223828|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
223829|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
223830|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
223831|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
223832|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
223833|NCT01296412|E2|Reported Event|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
223834|NCT01296412|E1|Reported Event|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
223835|NCT01296360|B3|Baseline|Total|Total of all reporting groups
223836|NCT01296360|B2|Baseline|Non-Booster Group|No treatment in study IC51-325
223837|NCT01296360|B1|Baseline|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
223838|NCT01296360|P2|Participant Flow|Non-Booster Group|No treatment in study IC51-325
223839|NCT01296360|P1|Participant Flow|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
223840|NCT01296360|O2|Outcome|>3 Years - <18 Years|booster vaccination: IXIARO 0.5 ml i.m (milliliter, intramuscular)
223841|NCT01296360|O1|Outcome|>14 Months to <2 Years|booster vaccination: IXIARO 0.25 ml i.m. (milliliter, intramuscular)
223842|NCT01296360|E2|Reported Event|Non-Booster Group|No treatment in study IC51-325
223843|NCT01296360|E1|Reported Event|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
223844|NCT01296347|B3|Baseline|Total|Total of all reporting groups
223845|NCT01296347|B2|Baseline|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours
Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
223846|NCT01296347|B1|Baseline|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
223847|NCT01296347|P2|Participant Flow|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours
Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
223848|NCT01296347|P1|Participant Flow|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
223849|NCT01296347|O2|Outcome|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours
Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
223850|NCT01296347|O1|Outcome|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
224044|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
223851|NCT01296347|E2|Reported Event|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours
Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
223852|NCT01296347|E1|Reported Event|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
223853|NCT01296152|B1|Baseline|Depo-medroxyprogesterone Acetate (DMPA)|"At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
Depo-medroxyprogesterone Acetate"
223854|NCT01296152|P1|Participant Flow|Depo-medroxyprogesterone Acetate (DMPA)|"At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
Depo-medroxyprogesterone Acetate"
223855|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223856|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223857|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223858|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223859|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223860|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223861|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223862|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223863|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223864|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223865|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223866|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223867|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223868|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223869|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223870|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223871|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223872|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223873|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223874|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223875|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223876|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223877|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223878|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223879|NCT01296152|E1|Reported Event|Arm A|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
223880|NCT01296035|B1|Baseline|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
223881|NCT01296035|P1|Participant Flow|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
223882|NCT01296035|O1|Outcome|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
223883|NCT01296035|O1|Outcome|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
223884|NCT01296035|E1|Reported Event|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
223885|NCT01295905|B3|Baseline|Total|Total of all reporting groups
223886|NCT01295905|B2|Baseline|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223887|NCT01295905|B1|Baseline|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223888|NCT01295905|P2|Participant Flow|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223889|NCT01295905|P1|Participant Flow|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223890|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223891|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223892|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223893|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223894|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223895|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223896|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223897|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223898|NCT01295905|E2|Reported Event|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223899|NCT01295905|E1|Reported Event|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
223900|NCT01295879|B1|Baseline|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
223901|NCT01295879|P1|Participant Flow|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
223902|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
223903|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
223904|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
223905|NCT01295879|E1|Reported Event|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
223906|NCT01295840|B1|Baseline|No Arms|All patient have a Quartet LV lead. No arms.
223907|NCT01295840|P1|Participant Flow|No Arms|All patient have a Quartet Left Ventricular (LV) lead. No arms.
223908|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
223909|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
223910|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
223911|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
223912|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
223913|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
223914|NCT01295840|O1|Outcome|Quartet LV Lead|All patient have a Quartet LV lead. No arms
223915|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
223916|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
223917|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
223918|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms.
223919|NCT01295840|E1|Reported Event|No Arms|All patient have a Quartet LV lead. No arms
223920|NCT01295814|B3|Baseline|Total|Total of all reporting groups
223921|NCT01295814|B2|Baseline|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
223922|NCT01295814|B1|Baseline|Inactive Drug|inactive drug : placebo
223923|NCT01295814|P2|Participant Flow|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
223924|NCT01295814|P1|Participant Flow|Inactive Drug|inactive drug : placebo
223925|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
223926|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
223927|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
223928|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
223929|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
223930|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
223931|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
223932|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
223933|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
223934|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
223935|NCT01295814|E2|Reported Event|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
223938|NCT01295281|B2|Baseline|LoFric PVC - POBE 2.0|"First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.
LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
223939|NCT01295281|B1|Baseline|LoFric POBE 2.0 - PVC|"First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC
LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
223940|NCT01295281|P2|Participant Flow|LoFric PVC - POBE 2.0|"First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.
LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
223941|NCT01295281|P1|Participant Flow|LoFric POBE 2.0 - PVC|"First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC
LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
223942|NCT01295281|O2|Outcome|LoFric PVC|Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
223943|NCT01295281|O1|Outcome|LoFric POBE 2.0|Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
223944|NCT01295281|E2|Reported Event|LoFric PVC|Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
223945|NCT01295281|E1|Reported Event|LoFric POBE 2.0|Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
223946|NCT01295216|B3|Baseline|Total|Total of all reporting groups
223947|NCT01295216|B2|Baseline|Control|Individuals who receive the usual primary health care
223948|NCT01295216|B1|Baseline|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months
Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
223949|NCT01295216|P2|Participant Flow|Control|Individuals who receive the usual primary health care
223950|NCT01295216|P1|Participant Flow|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months
Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
223951|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
223952|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months
Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
223953|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
223954|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months
Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
223955|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
223956|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months
Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
223957|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
223958|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months
Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
223959|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
223960|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months
Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
223961|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
223962|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months
Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
223963|NCT01295216|E2|Reported Event|Control|Individuals who receive the usual primary health care
223964|NCT01295216|E1|Reported Event|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months
Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
223965|NCT01295034|B3|Baseline|Total|Total of all reporting groups
223998|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224307|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
223966|NCT01295034|B2|Baseline|Tiered/Titrated Vitamin B Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
223967|NCT01295034|B1|Baseline|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) will receive 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
223968|NCT01295034|P2|Participant Flow|Tiered/Titrated Vitamin D Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
223969|NCT01295034|P1|Participant Flow|Conventional Vitamin D Treatment|conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
223970|NCT01295034|O2|Outcome|Tiered/Titrated Vitamin D Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
223971|NCT01295034|O1|Outcome|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
223972|NCT01295034|O2|Outcome|Tiered/Titrated Vitamin D Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
223973|NCT01295034|O1|Outcome|Conventional Vitamin D Treatment|conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
223974|NCT01295034|E2|Reported Event|Tiered/Titrated Vitamin B Dosing|Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
223975|NCT01295034|E1|Reported Event|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
223976|NCT01294917|B1|Baseline|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
223977|NCT01294917|P1|Participant Flow|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
223978|NCT01294917|O3|Outcome|OptiFree RepleniSH MPS|All subjects received the OptiFree RepleniSH MPS for one month for the care of their soft contact lenses.
223979|NCT01294917|O2|Outcome|Clear Care|All subjects received the Clear Care for one month for the care of their soft contact lenses.
223980|NCT01294917|O1|Outcome|AMO Investigational MPS|All subjects received the AMO Investigational MPS for one month for the care of their soft contact lenses.
223981|NCT01294917|E1|Reported Event|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
223982|NCT01294800|B5|Baseline|Total|Total of all reporting groups
223983|NCT01294800|B4|Baseline|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223984|NCT01294800|B3|Baseline|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223985|NCT01294800|B2|Baseline|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223986|NCT01294800|B1|Baseline|Preladenant 2 mg|Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.
223987|NCT01294800|P4|Participant Flow|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223988|NCT01294800|P3|Participant Flow|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223989|NCT01294800|P2|Participant Flow|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223990|NCT01294800|P1|Participant Flow|Preladenant 2 mg|Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.
223991|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223992|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223993|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223994|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223995|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223996|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
223997|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224042|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
223999|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224000|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224001|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224002|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224003|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224004|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224005|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224006|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224007|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224008|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224009|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224010|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224011|NCT01294800|E4|Reported Event|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224012|NCT01294800|E3|Reported Event|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224013|NCT01294800|E2|Reported Event|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224014|NCT01294800|E1|Reported Event|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
224015|NCT01294787|B1|Baseline|All Participants|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods. One participant was randomized but did not receive study drug.
224016|NCT01294787|P6|Participant Flow|Tiotropium / Placebo / QVA149|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
224017|NCT01294787|P5|Participant Flow|Tiotropium / QAV149 / Placebo|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
224018|NCT01294787|P4|Participant Flow|Placebo / Tiotropium / QVA149|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
224019|NCT01294787|P3|Participant Flow|Placebo / QVA149 / Tiotropium|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
224020|NCT01294787|P2|Participant Flow|QVA149 / Tiotropium / Placebo|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
224021|NCT01294787|P1|Participant Flow|QVA149 / Placebo / Tiotropium|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
224022|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
224023|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
224024|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
224025|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
224026|NCT01294787|O1|Outcome|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
224027|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
224028|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
224029|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
224030|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
224031|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
224032|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
224033|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
224034|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
224035|NCT01294787|O1|Outcome|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
224036|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
224037|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
224038|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
224039|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
224040|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
224041|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
224047|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
224048|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
224049|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
224050|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
224051|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
224052|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
224053|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
224054|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
224055|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
224056|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
224057|NCT01294787|O2|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
224058|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
224059|NCT01294787|E3|Reported Event|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
224060|NCT01294787|E2|Reported Event|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
224061|NCT01294787|E1|Reported Event|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
224062|NCT01294748|B3|Baseline|Total|Total of all reporting groups
224063|NCT01294748|B2|Baseline|Endeavor DES|Active Comparator: Endeavor DES
224064|NCT01294748|B1|Baseline|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224065|NCT01294748|P2|Participant Flow|Endeavor DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224066|NCT01294748|P1|Participant Flow|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224067|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
224068|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224069|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
224070|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224071|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
224072|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224073|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
224074|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224075|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
224076|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224077|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
224078|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224079|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
224080|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224081|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
224082|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224083|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
224084|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224085|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
224086|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224087|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
224088|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224089|NCT01294748|E2|Reported Event|Endeavor DES|Active Comparator: Endeavor DES
224090|NCT01294748|E1|Reported Event|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
224091|NCT01294709|B1|Baseline|All Enrolled Participants|All enrolled participants who recieved at least one dose of either telcagepant or placebo.
224092|NCT01294709|P2|Participant Flow|Placebo Then Telcagepant|Participants receive single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 1 and a single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
224129|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
224564|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
224093|NCT01294709|P1|Participant Flow|Telcagepant Then Placebo|Participants receive single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 1 and single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
224094|NCT01294709|O2|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
224095|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
224096|NCT01294709|O2|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
224097|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
224098|NCT01294709|O2|Outcome|Placebo|Participants who received single oral dose of placebo in Period 1 or 2 of crossover
224099|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
224100|NCT01294709|O3|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
224101|NCT01294709|O2|Outcome|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
224102|NCT01294709|O1|Outcome|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
224103|NCT01294709|O3|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
224104|NCT01294709|O2|Outcome|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
224105|NCT01294709|O1|Outcome|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
224106|NCT01294709|E3|Reported Event|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
224107|NCT01294709|E2|Reported Event|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
224108|NCT01294709|E1|Reported Event|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
224109|NCT01294696|B3|Baseline|Total|Total of all reporting groups
224110|NCT01294696|B2|Baseline|Participants With Inadequate Pain Relief|Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
224111|NCT01294696|B1|Baseline|Participants With Adequate Pain Relief|Adequate pain relief was defined as an average pain score of <=4 on the Brief Pain Inventory (BPI). Baseline characteristics are only reported for participants with data available at baseline.
224112|NCT01294696|P1|Participant Flow|All Enrolled Participants|The population consisted of all enrolled participants with adequate and inadequate pain relief.
224113|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
224114|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
224115|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
224116|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
224117|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
224118|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
224119|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
224120|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
224121|NCT01294696|E2|Reported Event|Participants With Inadequate Pain Relief|Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
224122|NCT01294696|E1|Reported Event|Participants With Adequate Pain Relief|Adequate pain relief was fedined as an average pain score of <=4 on the Brief Pain Inventory (BPI).
224123|NCT01294683|B3|Baseline|Total|Total of all reporting groups
224124|NCT01294683|B2|Baseline|Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g|After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.
224125|NCT01294683|B1|Baseline|Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg|After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks.
224126|NCT01294683|P2|Participant Flow|Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g|After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.
224127|NCT01294683|P1|Participant Flow|Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg|After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks.
224130|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
224131|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
224132|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
224133|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
224134|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
224135|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
224136|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
224137|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
224138|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
224139|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
224140|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
224141|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
224142|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
224143|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
224144|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
224145|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
224146|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
224147|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
224148|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
224149|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
224150|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
224151|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
224152|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
224153|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
224154|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
224155|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
224156|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
224157|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
224158|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
224159|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
224160|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
224161|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
224162|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
224163|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
224164|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
224165|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
224166|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
224167|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
224168|NCT01294683|O2|Outcome|MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
224169|NCT01294683|O1|Outcome|MK-0524B 2g/40mg|Participants who received MK-0524B 2g/40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
224170|NCT01294683|O2|Outcome|MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
224171|NCT01294683|O1|Outcome|MK-0524B 2g/40mg|Participants who received MK-0524B 2g/40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
224172|NCT01294683|E4|Reported Event|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
224173|NCT01294683|E3|Reported Event|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III
224299|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224174|NCT01294683|E2|Reported Event|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
224175|NCT01294683|E1|Reported Event|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
224176|NCT01294644|B4|Baseline|Total|Total of all reporting groups
224177|NCT01294644|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224178|NCT01294644|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
224179|NCT01294644|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224180|NCT01294644|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224181|NCT01294644|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
224182|NCT01294644|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224183|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224184|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
224185|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224186|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224187|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
224188|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224189|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224190|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
224191|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224192|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224193|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
224194|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224195|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224196|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
224197|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224198|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224199|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
224200|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224201|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224202|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
224203|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224300|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224204|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224205|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
224206|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224207|NCT01294644|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224208|NCT01294644|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
224209|NCT01294644|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
224210|NCT01294592|B3|Baseline|Total|Total of all reporting groups
224211|NCT01294592|B2|Baseline|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224212|NCT01294592|B1|Baseline|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224213|NCT01294592|P2|Participant Flow|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224214|NCT01294592|P1|Participant Flow|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224215|NCT01294592|O3|Outcome|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
224216|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224217|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224218|NCT01294592|O2|Outcome|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
224219|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224220|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224221|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224222|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224223|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224224|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224225|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224301|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224302|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224226|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224227|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224228|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224229|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224230|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224231|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224232|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224233|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224234|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224235|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224236|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
224237|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224238|NCT01294592|E3|Reported Event|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
224239|NCT01294592|E2|Reported Event|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
224240|NCT01294592|E1|Reported Event|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
224241|NCT01294553|B1|Baseline|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
224242|NCT01294553|P1|Participant Flow|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to the appropriate dose of Avandamet tablet based on their current regimen (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg). Participants were not to have exceeded the maximum recommended daily dose of 8/2000. All participants were to have started the rosiglitazone component of Avandamet at the lowest recommended dose, and all dose increases should have been accompanied by careful monitoring for adverse events related to fluid retention.
224243|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 mg, 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
224244|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 mg, 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
224303|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224304|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224245|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
224246|NCT01294553|E1|Reported Event|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
224247|NCT01294514|B1|Baseline|Healthy Volunteers|Healthy volunteers were studied
224248|NCT01294514|P1|Participant Flow|Respiration Rate in Healthy Volunteers|"Healthy volunteer participants were monitored for 30 minute period to collect respiratory rate information from non-invasive sensors.
Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide."
224249|NCT01294514|O1|Outcome|Healthy Volunteers|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide.
224250|NCT01294514|O1|Outcome|Healthy Volunteers|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide derived respiration rates were recorded on all the volunteers simultaneously.
224251|NCT01294514|O3|Outcome|Respiration Rate From Transthoracic Impedance|Respiration Rate determined by Transthoracic Impedance
224252|NCT01294514|O2|Outcome|Respiration Rate From Endtidal Carbon Dioxide|Respiration Rate determined by manual overscoring of capnography waveforms.
224253|NCT01294514|O1|Outcome|Respiration Rate From Covidien Respiration Rate Software|Respiration Rate determined by novel plethysmographic analysis
224254|NCT01294514|E1|Reported Event|Healthy Volunteers|A selection of subjects from the general population from ages 18 - 50.
224255|NCT01294462|B3|Baseline|Total|Total of all reporting groups
224256|NCT01294462|B2|Baseline|Clopidogrel|Clopidogrel 75mg od
224257|NCT01294462|B1|Baseline|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90 mg bid
224258|NCT01294462|P2|Participant Flow|Clopidogrel|Clopidogrel 75mg od
224259|NCT01294462|P1|Participant Flow|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90 mg bid
224260|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
224261|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
224262|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
224263|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
224264|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
224265|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
224266|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
224267|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
224268|NCT01294462|E2|Reported Event|Clopidogrel|Clopidogrel 75mg od
224269|NCT01294462|E1|Reported Event|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
224270|NCT01294449|B3|Baseline|Total|Total of all reporting groups
224271|NCT01294449|B2|Baseline|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
224272|NCT01294449|B1|Baseline|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
224273|NCT01294449|P2|Participant Flow|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
224274|NCT01294449|P1|Participant Flow|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
224275|NCT01294449|O2|Outcome|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
224276|NCT01294449|O1|Outcome|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
224277|NCT01294449|E2|Reported Event|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
224278|NCT01294449|E1|Reported Event|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
224279|NCT01294436|B3|Baseline|Total|Total of all reporting groups
224280|NCT01294436|B2|Baseline|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224281|NCT01294436|B1|Baseline|Monotherapy|Dapagliflozin 5/10 mg only
224282|NCT01294436|P2|Participant Flow|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224283|NCT01294436|P1|Participant Flow|Monotherapy|Dapagliflozin 5/10 mg only
224284|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224285|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224286|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224287|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224288|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224289|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224290|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224291|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224292|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224293|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224294|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224295|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224296|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224297|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224298|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224308|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224309|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224310|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224311|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
224312|NCT01294436|E2|Reported Event|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
224313|NCT01294436|E1|Reported Event|Monotherapy|Dapagliflozin 5/10 mg only
224314|NCT01294423|B4|Baseline|Total|Total of all reporting groups
224315|NCT01294423|B3|Baseline|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
224316|NCT01294423|B2|Baseline|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
224317|NCT01294423|B1|Baseline|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
224318|NCT01294423|P3|Participant Flow|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
224319|NCT01294423|P2|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
224320|NCT01294423|P1|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
224321|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
224322|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
224323|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
224324|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
224325|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
224326|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
224327|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
224328|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
224329|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
224330|NCT01294423|E3|Reported Event|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
224331|NCT01294423|E2|Reported Event|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
224332|NCT01294423|E1|Reported Event|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
224333|NCT01294397|B1|Baseline|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
224334|NCT01294397|P1|Participant Flow|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
224335|NCT01294397|O1|Outcome|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
224336|NCT01294397|O1|Outcome|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
224337|NCT01294397|O1|Outcome|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
224338|NCT01294397|O1|Outcome|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
224339|NCT01294397|O1|Outcome|Etanercept + Denosumab|Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
224340|NCT01294397|E3|Reported Event|All Subjects On-study|"Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
Adverse events are reported from day -28 up to day 176."
224341|NCT01294397|E2|Reported Event|Etanercept 50 mg + Denosumab 60 mg Day 8 - EOS|"Participants received etanercept 50 mg subcutaneously once weekly. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
Adverse events are reported from day 8 to end of study (day 176)."
224342|NCT01294397|E1|Reported Event|Etanercept 50 mg Day - 28 - Day 7|Participants received etanercept 50 mg subcutaneously once weekly. Adverse events are reported from day -28 until day 7.
224343|NCT01294384|B4|Baseline|Total|Total of all reporting groups
224344|NCT01294384|B3|Baseline|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
224345|NCT01294384|B2|Baseline|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
224346|NCT01294384|B1|Baseline|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
224347|NCT01294384|P3|Participant Flow|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
224348|NCT01294384|P2|Participant Flow|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
224349|NCT01294384|P1|Participant Flow|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
224350|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
224598|NCT01292642|O1|Outcome|Baseline - Cannabis Inhalations Per Day|CBT plus NRT
224351|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
224352|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
224353|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
224354|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
224355|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
224356|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
224357|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
224358|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
224359|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
224360|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
224361|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
224362|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
224363|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
224364|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
224365|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
224366|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
224367|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
224368|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
224369|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
224370|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
224371|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
224372|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
224373|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
224374|NCT01294384|E3|Reported Event|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
224375|NCT01294384|E2|Reported Event|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
224376|NCT01294384|E1|Reported Event|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
224377|NCT01294371|B1|Baseline|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.
Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
224378|NCT01294371|P1|Participant Flow|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.
Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
224379|NCT01294371|O3|Outcome|No Add-Back Therapy|Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and no add-back therapy.
224380|NCT01294371|O2|Outcome|Plus Add-Back Therapy|Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and add-back therapy following local guidelines or therapeutic recommendations.
224443|NCT01294046|O1|Outcome|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine
Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
224499|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224381|NCT01294371|O1|Outcome|Overall|"Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was carried out on the 3rd day of a menstrual period.
Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was impossible — phytoestrogens with calcium products."
224382|NCT01294371|O1|Outcome|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.
Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
224383|NCT01294371|O1|Outcome|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.
Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
224384|NCT01294371|E1|Reported Event|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.
Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
224385|NCT01294306|B3|Baseline|Total|Total of all reporting groups
224386|NCT01294306|B2|Baseline|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
224387|NCT01294306|B1|Baseline|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
224388|NCT01294306|P2|Participant Flow|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
224389|NCT01294306|P1|Participant Flow|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
224390|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
224391|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
224392|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
224393|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
224394|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
224395|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
224396|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
224397|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
224398|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
224399|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
224400|NCT01294306|E2|Reported Event|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
224401|NCT01294306|E1|Reported Event|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
224402|NCT01294228|B1|Baseline|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
224403|NCT01294228|P1|Participant Flow|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
224404|NCT01294228|O1|Outcome|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
224405|NCT01294228|E1|Reported Event|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
224406|NCT01294163|B4|Baseline|Total|Total of all reporting groups
224407|NCT01294163|B3|Baseline|TIVA|Anesthetic agent before and after CPB: propofol
224408|NCT01294163|B2|Baseline|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
224409|NCT01294163|B1|Baseline|Xenon|Anesthetic agent before and after CPB: xenon
224410|NCT01294163|P3|Participant Flow|TIVA|Anesthetic agent before and after CPB: propofol
224411|NCT01294163|P2|Participant Flow|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
224412|NCT01294163|P1|Participant Flow|Xenon Including Pilot Patients|Anesthetic agent before and after CPB: xenon
224413|NCT01294163|O2|Outcome|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
224414|NCT01294163|O1|Outcome|Xenon|Anesthetic agent before and after CPB: xenon
224415|NCT01294163|O2|Outcome|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
224416|NCT01294163|O1|Outcome|Xenon|Anesthetic agent before and after CPB: xenon
224417|NCT01294163|E3|Reported Event|TIVA|Anesthetic agent before and after CPB: propofol
224418|NCT01294163|E2|Reported Event|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
224419|NCT01294163|E1|Reported Event|Xenon Including Pilot Patients|Anesthetic agent before and after CPB: xenon
224420|NCT01294150|B3|Baseline|Total|Total of all reporting groups
224421|NCT01294150|B2|Baseline|Cystoscopy|Sham treatment entailed rigid cystoscopy, a blinding screen and sounds that mimicked those of the prostatic urethral lift procedure.
224422|NCT01294150|B1|Baseline|UroLift System|Average of 4.9 implants per prostate implanted. The prostatic urethral lift is performed by placing permanent transprostatic implants to lift apart the prostate lobes and reduce urethral obstruction.
224423|NCT01294150|P2|Participant Flow|Cystoscopy (Control/Sham)|The control group subjects underwent a cystoscopy procedure. The subject was blinded as to whether he was randomized to the control or treatment group. Unblinding occurred at 3 months post procedure after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo procedure with the UroLift system, provided he met the inclusion and exclusion criteria. Subjects crossing over are then to be followed for 5 years post-treatment. If subject did not crossover, his participation was not required beyond the 12 month visit.
224424|NCT01294150|P1|Participant Flow|UroLift System|The treatment group subjects underwent the UroLift (UL)system procedure. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to be retreated with the UroLift system if he met the retreatment inclusion and exclusion criteria. Subjects that went on to UL retreatment within the first 12 months were considered treatment failures, but started their follow-up schedule over. All subjects will be followed at a minimum of 5 years per the assessment schedule.
224425|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
224426|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
224427|NCT01294150|O2|Outcome|Cystoscopy|The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
224428|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
224429|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.
224430|NCT01294150|E2|Reported Event|Cystoscopy|The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
224431|NCT01294150|E1|Reported Event|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
224432|NCT01294046|B1|Baseline|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine
Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
224433|NCT01294046|P1|Participant Flow|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine
Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
224434|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine
Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine
No data were collected from this entire study, so no data were analyzed."
224435|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine
Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine
No data were collected from this entire study, so no data were analyzed."
224436|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine
Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine
No data were collected from this entire study, so no data were analyzed."
224437|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine
Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine
No data were collected from this entire study, so no data were analyzed."
224438|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine
Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine
No data were collected from this entire study, so no data were analyzed."
224439|NCT01294046|O1|Outcome|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine
Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
224440|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine
Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine
No outcome measure data was analyzed because no outcome data were collected."
224441|NCT01294046|O1|Outcome|Experimental: Deep Brain Stimulation Arm Group|"Experimental: Deep brain stimulation arm group
Electrical Stimulation of SPG for Treatment of Migraine"
224442|NCT01294046|O1|Outcome|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine
Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
224560|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
224561|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
224444|NCT01294046|E1|Reported Event|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine
Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
224445|NCT01293968|B3|Baseline|Total|Total of all reporting groups
224446|NCT01293968|B2|Baseline|Diphenhydramine and Aluminium MgS|
224447|NCT01293968|B1|Baseline|Ibuprofen, Diphenhydramine and Aluminium MgS|
224448|NCT01293968|P2|Participant Flow|Diphenhydramine and Aluminium MgS|
224449|NCT01293968|P1|Participant Flow|Ibuprofen, Diphenhydramine and Aluminium MgS|
224450|NCT01293968|O2|Outcome|Diphenhydramine and Aluminium MgS|the group received the placebo solution containing 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
224451|NCT01293968|O1|Outcome|Ibuprofen, Diphenhydramine and Aluminium MgS|the group received the study solution containing 5cc ibuprofen 100mg, 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
224452|NCT01293968|E2|Reported Event|Diphenhydramine and Aluminium MgS|
224453|NCT01293968|E1|Reported Event|Ibuprofen, Diphenhydramine and Aluminium MgS|
224454|NCT01293825|B1|Baseline|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224455|NCT01293825|P1|Participant Flow|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224456|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224457|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224458|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224459|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224460|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224461|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224462|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224463|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224464|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224465|NCT01293825|E1|Reported Event|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study."
224466|NCT01293695|B3|Baseline|Total|Total of all reporting groups
224467|NCT01293695|B2|Baseline|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy
Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
224468|NCT01293695|B1|Baseline|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy (HRT)
Hypnosis: Hypnosis relaxation in five weekly sessions"
224469|NCT01293695|P2|Participant Flow|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy
Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
224470|NCT01293695|P1|Participant Flow|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy
Hypnosis: Hypnosis relaxation in five weekly sessions"
224471|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy
Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
224472|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy
Hypnosis: Hypnosis relaxation in five weekly sessions"
224473|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy
Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
224474|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy
Hypnosis: Hypnosis relaxation in five weekly sessions."
224475|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy
Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
224476|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy
Hypnosis: Hypnosis relaxation in five weekly sessions."
224477|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy
Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
224478|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy
Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged."
224479|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy
Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
224480|NCT01293695|O1|Outcome|Hypnosis|"Received 5 weeks of hypnotic relaxation therapy
Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged."
224481|NCT01293695|E2|Reported Event|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy
Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
224482|NCT01293695|E1|Reported Event|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy
Hypnosis: Hypnosis relaxation in five weekly sessions"
224483|NCT01293539|B1|Baseline|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.
Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
224484|NCT01293539|P1|Participant Flow|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.
Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
224485|NCT01293539|O1|Outcome|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.
Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
224486|NCT01293539|E1|Reported Event|Intra-arterial Chemotherapy|"IAC is offered to all patients with intraocular Rb who are deemed eligible after evaluation under anesthesia (EUA),with the exception of those few patients for whom focal modalities (i.e., laser or cryotherapy) would be effective.In cases of bilateral disease, both eyes would be treated sequentially during the same procedure utilizing the same femoral access site.
Two cycles of IAC will be performed at 3 to 4 week intervals. Melphalan dosing: 3-6 mth-old, 2.5mg; 3-12 mth-old, 3mg; 1-3 yr-old, 4mg; >3 yr-old, 5mg. For those tumors that have shown appropriate response and are amenable to local therapies, then no additional IAC will be performed. If the tumors do not regress after 2 cycles, then a third cycle of IAC will be offered. Local therapies (laser, cryotherapy) will not be given during the EUAs conducted prior to each treatment session, but will be allowed after toxicity and response has been assessed 3-4 weeks after the final cycle of intra-arterial therapy."
224487|NCT01293240|B1|Baseline|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224488|NCT01293240|P1|Participant Flow|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224489|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224490|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224491|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224492|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224493|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224494|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224495|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224496|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224497|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224498|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224562|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
224500|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224501|NCT01293240|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
224502|NCT01293084|B1|Baseline|Children With CF|Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
224503|NCT01293084|P1|Participant Flow|Children With CF|Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
224504|NCT01293084|O2|Outcome|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes
0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
224505|NCT01293084|O1|Outcome|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.
7% saline: 5mL 7% saline inhaled once over 20 minutes"
224506|NCT01293084|O2|Outcome|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes
0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
224507|NCT01293084|O1|Outcome|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.
7% saline: 5mL 7% saline inhaled once over 20 minutes"
224508|NCT01293084|E2|Reported Event|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes
0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
224509|NCT01293084|E1|Reported Event|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.
7% saline: 5mL 7% saline inhaled once over 20 minutes"
224510|NCT01293032|B5|Baseline|Total|Total of all reporting groups
224511|NCT01293032|B4|Baseline|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
Systemic chemotherapy"
224512|NCT01293032|B3|Baseline|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
Systemic chemotherapy"
224513|NCT01293032|B2|Baseline|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
Hormonal therapy:
Tamoxifen Citrate (pre-menopausal women) OR
Aromatase Inhibition Therapy (post-menopausal women)"
224514|NCT01293032|B1|Baseline|Group 1 (RS < 11)|"Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
Hormonal therapy:
Tamoxifen Citrate (pre-menopausal women) OR
Aromatase Inhibition Therapy (post-menopausal women)"
224515|NCT01293032|P4|Participant Flow|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
Systemic chemotherapy"
224516|NCT01293032|P3|Participant Flow|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
Systemic chemotherapy"
224517|NCT01293032|P2|Participant Flow|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
Hormonal therapy:
Tamoxifen Citrate (pre-menopausal women) OR
Aromatase Inhibition Therapy (post-menopausal women)"
224518|NCT01293032|P1|Participant Flow|Group 1 (RS < 11)|"Patients with a RS of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
Hormonal therapy:
Tamoxifen Citrate (pre-menopausal women) OR
Aromatase Inhibition Therapy (post-menopausal women)"
224519|NCT01293032|O1|Outcome|Group 2 (RS 11-25)|Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy.
224520|NCT01293032|E4|Reported Event|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
Systemic chemotherapy"
224521|NCT01293032|E3|Reported Event|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
Systemic chemotherapy"
224522|NCT01293032|E2|Reported Event|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
Hormonal therapy:
Tamoxifen Citrate (pre-menopausal women) OR
Aromatase Inhibition Therapy (post-menopausal women)"
224523|NCT01293032|E1|Reported Event|Group 1 (RS < 11)|"Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.
Treatment:
Neoadjuvant therapy
Therapeutic conventional surgery
Laboratory biomarker analysis/Correlative studies
Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
Hormonal therapy:
Tamoxifen Citrate (pre-menopausal women) OR
Aromatase Inhibition Therapy (post-menopausal women)"
224524|NCT01293006|B5|Baseline|Total|Total of all reporting groups
224525|NCT01293006|B4|Baseline|Placebo Then Suvorexant (30 mg)|During Period 1, participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
224526|NCT01293006|B3|Baseline|Placebo Then Suvorexant (40 mg)|During Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
224527|NCT01293006|B2|Baseline|Suvorexant (30 mg) Then Placebo|During Period 1, participants ≥65 years of age were administered a 30-mg oral dose of MK-suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
224528|NCT01293006|B1|Baseline|Suvorexant (40 mg) Then Placebo|During Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of, at least, 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
224529|NCT01293006|P4|Participant Flow|Placebo Then Suvorexant (30 mg)|During Period 1, participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
224530|NCT01293006|P3|Participant Flow|Placebo Then Suvorexant (40 mg)|During Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
224531|NCT01293006|P2|Participant Flow|Suvorexant (30 mg) Then Placebo|During Period 1, participants ≥65 years of age were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
224532|NCT01293006|P1|Participant Flow|Suvorexant (40 mg) Then Placebo|During Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
224533|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
224534|NCT01293006|O1|Outcome|Suvorexant (40 mg or 30 mg)|Participants administered either a 40-mg or a 30-mg dose of suvorexant.
224535|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
224536|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or a 30-mg dose of suvorexant.
224537|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
224538|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or 30-mg dose of suvorexant.
224539|NCT01293006|O2|Outcome|Placebo|Participants receiving placebo.
224540|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants receiving either a 40-mg or 30-mg dose of suvorexant.
224541|NCT01293006|O3|Outcome|Placebo|Participants administered placebo.
224542|NCT01293006|O2|Outcome|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
224543|NCT01293006|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg oral dose of suvorexant.
224544|NCT01293006|O3|Outcome|Placebo|Participants administered placebo.
224545|NCT01293006|O2|Outcome|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
224546|NCT01293006|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg oral dose of suvorexant.
224547|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
224548|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or a 30-mg oral dose of suvorexant.
224549|NCT01293006|E3|Reported Event|Placebo|Participants administered placebo.
224550|NCT01293006|E2|Reported Event|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
224551|NCT01293006|E1|Reported Event|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
224552|NCT01292928|B1|Baseline|Innova Stent|Stent implantation into SFA/PPA
224553|NCT01292928|P1|Participant Flow|Innova Stent|Stent implantation into Superficial Femoral Artery (SFA) / Proximal Popliteal Artery (PPA)
224554|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
224555|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
224556|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
224557|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
224558|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
224559|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
224565|NCT01292928|O2|Outcome|Innova Stent Entire Matrix (20-200 mm)|Entire Matrix Stent implantation into SFA/PPA
224566|NCT01292928|O1|Outcome|Innova Stent Core Matrix (20-150 mm)|Core Matrix Stent implantation into SFA/PPA
224567|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
224568|NCT01292928|E1|Reported Event|Innova Stent|Stent implantation into SFA/PPA
224569|NCT01292876|B1|Baseline|Extracellular Matrix|"Implantation of Extracellular Matrix
Extracellular Matrix: Extracellular Matrix"
224570|NCT01292876|P1|Participant Flow|Extracellular Matrix|Overall number of participants for which baseline characteristics were measured for all baseline measures reported..
224571|NCT01292876|O1|Outcome|Extracellular Matrix|Overall number of participants for which characteristics were measured for all measures reported..
224572|NCT01292876|O1|Outcome|Extracellular Matrix|Participants for which final characteristics and functional evaluations were measured for all measures reported.
224573|NCT01292876|E2|Reported Event|Extracellular Matrix_Exp|Experimental group; post implantation of ECM
224574|NCT01292876|E1|Reported Event|Extracellular Matrix_Control|Control (prior to implantation of ECM)
224575|NCT01292837|B1|Baseline|Levetiracetam|"Twice daily (morning and evening) orally
Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
224576|NCT01292837|P1|Participant Flow|Levetiracetam|"Twice daily (morning and evening) orally
Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
224577|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally
Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
224578|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally
Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
224579|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally
Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
224580|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally
Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
224581|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally
Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
224582|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally
Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
224583|NCT01292837|E1|Reported Event|Levetiracetam|"Twice daily (morning and evening) orally
Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
224584|NCT01292798|B1|Baseline|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
224585|NCT01292798|P1|Participant Flow|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
224586|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.
Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
224587|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.
Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
224588|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.
Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
224589|NCT01292798|E1|Reported Event|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
224590|NCT01292746|B1|Baseline|Erchonia MLS|The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
224591|NCT01292746|P1|Participant Flow|Erchonia MLS|Erchonia MLS employs four diodes emitting 10 milliwatts (mW) 635 nanometer (nm) red laser light.
224592|NCT01292746|O1|Outcome|Erchonia MLS|Erchonia MLS: The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
224593|NCT01292746|E1|Reported Event|Erchonia MLS|The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
224594|NCT01292642|B1|Baseline|Treatment|CBT plus NRT
224595|NCT01292642|P1|Participant Flow|Treatment|Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
224596|NCT01292642|O1|Outcome|Treatment|CBT plus NRT
224597|NCT01292642|O2|Outcome|Post Treatment - Cannabis Inhalations Per Day|
224599|NCT01292642|O2|Outcome|PostTreatment - Cigarettes Per Day|CBT plus NRT
224600|NCT01292642|O1|Outcome|Baseline - Cigarettes Per Day|
224601|NCT01292642|E1|Reported Event|Treatment|CBT plus NRT
224602|NCT01292629|B1|Baseline|iSert® 251 Intraocular Lens|Population Description: A total of 125 subjects were implanted with the iSert® IOL. Data analysis for baseline characteristics was completed on these 125 subjects.
224603|NCT01292629|P1|Participant Flow|iSert 251: iSert 251 Intraocular Lens|Implantation with the iSert® 251 Intraocular lens
224604|NCT01292629|O1|Outcome|iSert 251 Aphakik IOL|iSert 251: iSert 251 intraocular lens
224605|NCT01292629|O1|Outcome|iSert 251: iSert 251 Intraocular Lens|Eligible subjects underwent phacoemulsification cataract extraction surgery and were implanted with the iSert® Intraocular Lens. Study observation was up to 271 days.
224606|NCT01292629|E1|Reported Event|iSert 251: iSert 251 Intraocular Lens|Subjects who underwent phacoemulsification cataract extraction surgery who were implanted with the iSert aphakic intraocular lens.
224607|NCT01292603|B6|Baseline|Total|Total of all reporting groups
224608|NCT01292603|B5|Baseline|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224609|NCT01292603|B4|Baseline|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224610|NCT01292603|B3|Baseline|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224611|NCT01292603|B2|Baseline|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224612|NCT01292603|B1|Baseline|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224613|NCT01292603|P6|Participant Flow|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224614|NCT01292603|P5|Participant Flow|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224615|NCT01292603|P4|Participant Flow|No SC Dose Received|These participants were withdrawn prior to SC treatment.
224616|NCT01292603|P3|Participant Flow|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224617|NCT01292603|P2|Participant Flow|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224618|NCT01292603|P1|Participant Flow|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 milligrams per square meter (mg/m^2) on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224667|NCT01292538|O1|Outcome|Erchonia GLS 532nm|"532nm green laser light therapy.
Erchonia GLS: 532 nm green diode low level laser light device"
224619|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224620|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224621|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224622|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224623|NCT01292603|O5|Outcome|No SC Dose Received|These participants were withdrawn prior to SC treatment.
224624|NCT01292603|O4|Outcome|Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224625|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224626|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224627|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224628|NCT01292603|O5|Outcome|No SC Dose Received|These participants were withdrawn prior to SC treatment.
224629|NCT01292603|O4|Outcome|Part 1: Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224630|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224631|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224632|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224668|NCT01292538|E2|Reported Event|Placebo Laser|"Sham light output with no therapeutic benefit
Placebo laser: Sham light output with no therapeutic benefit"
224669|NCT01292538|E1|Reported Event|Erchonia GLS 532nm|"532nm green laser light therapy.
Erchonia GLS: 532 nm green diode low level laser light device"
225969|NCT01289028|O1|Outcome|Nilotinib|ITT
224633|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224634|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224635|NCT01292603|O1|Outcome|Part 1: Rituximab SC|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224636|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224637|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224638|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224639|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224640|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224641|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224642|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224643|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224644|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224645|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224646|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224647|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224648|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224649|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224650|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224651|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224652|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224653|NCT01292603|O1|Outcome|Part 1: Rituximab SC|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224654|NCT01292603|E7|Reported Event|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: SC rituximab 1600 mg on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224655|NCT01292603|E6|Reported Event|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 0
Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1
Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224656|NCT01292603|E5|Reported Event|No SC Dose Received|These participants were withdrawn prior to SC treatment.
224657|NCT01292603|E4|Reported Event|Part 1: Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224658|NCT01292603|E3|Reported Event|Part 1: Rituximab SC 1870 mg|"PParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224659|NCT01292603|E2|Reported Event|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224660|NCT01292603|E1|Reported Event|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.
Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
224661|NCT01292538|B3|Baseline|Total|Total of all reporting groups
224662|NCT01292538|B2|Baseline|Placebo Laser|"Sham light output with no therapeutic benefit
Placebo laser: Sham light output with no therapeutic benefit"
224663|NCT01292538|B1|Baseline|Erchonia GLS 532nm|"532nm green laser light therapy.
Erchonia GLS: 532 nm green diode low level laser light device"
224664|NCT01292538|P2|Participant Flow|Placebo Laser|"Sham light output with no therapeutic benefit
Placebo laser: Sham light output with no therapeutic benefit"
224665|NCT01292538|P1|Participant Flow|Erchonia GLS 532nm|"532nm green laser light therapy.
Erchonia GLS: 532 nm green diode low level laser light device"
224666|NCT01292538|O2|Outcome|Placebo Laser|"Sham light output with no therapeutic benefit
Placebo laser: Sham light output with no therapeutic benefit"
224816|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
224670|NCT01292486|B1|Baseline|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
224671|NCT01292486|P1|Participant Flow|All Per Protocol Patients|This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.
224672|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
224673|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
224674|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
224675|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
224676|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
224677|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
224678|NCT01292486|O1|Outcome|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
224679|NCT01292486|E1|Reported Event|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
224680|NCT01292473|B5|Baseline|Total|Total of all reporting groups
224681|NCT01292473|B4|Baseline|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
224682|NCT01292473|B3|Baseline|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
224683|NCT01292473|B2|Baseline|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
224684|NCT01292473|B1|Baseline|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
224685|NCT01292473|P4|Participant Flow|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
224686|NCT01292473|P3|Participant Flow|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
224687|NCT01292473|P2|Participant Flow|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
224688|NCT01292473|P1|Participant Flow|Placebo|Placebo subcutaneously (sc) every 4 weeks.
224689|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
224690|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
224691|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
224692|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
224693|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
224694|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
224695|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
224696|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
224697|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
224698|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
224699|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
224700|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
224701|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
224702|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
224703|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
224704|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
224705|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
224706|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
224707|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
224708|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
224709|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
224710|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
224711|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
224712|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
224713|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
224714|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
224715|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
224716|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
224717|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
224718|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
224719|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
224720|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
224721|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
224722|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
224723|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
224724|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
224725|NCT01292473|E4|Reported Event|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
224726|NCT01292473|E3|Reported Event|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
224727|NCT01292473|E2|Reported Event|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
224728|NCT01292473|E1|Reported Event|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
224729|NCT01292304|B1|Baseline|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
224730|NCT01292304|P1|Participant Flow|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
224731|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
224732|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
224733|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
224734|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
224735|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
224736|NCT01292304|E1|Reported Event|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
224737|NCT01292265|B1|Baseline|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
224738|NCT01292265|P1|Participant Flow|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
224739|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
224740|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
224741|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
224742|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
224743|NCT01292265|E1|Reported Event|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
224744|NCT01292239|B3|Baseline|Total|Total of all reporting groups
224745|NCT01292239|B2|Baseline|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
224746|NCT01292239|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224747|NCT01292239|P2|Participant Flow|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
224748|NCT01292239|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224749|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224750|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224751|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224752|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
224753|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224754|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
225970|NCT01289028|O1|Outcome|Nilotinib|
224755|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224756|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
224757|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224758|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
224759|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224760|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
224761|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224762|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
224763|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224764|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
224765|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224766|NCT01292239|E2|Reported Event|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
224767|NCT01292239|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
224768|NCT01292226|B1|Baseline|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224769|NCT01292226|P1|Participant Flow|Mycophenolate Mofetil (MMF) Monotherapy|Participants received an initial dose of MMF 1 gram (g), orally (PO), twice per day (BID), started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224770|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224771|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224772|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224817|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
224818|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
225971|NCT01289028|O1|Outcome|Nilotinib|
224773|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224774|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224775|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224776|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224777|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224778|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224779|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224780|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224781|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224782|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224783|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224784|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224785|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224786|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224787|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224788|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224789|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224790|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224791|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224819|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
224792|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224793|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224794|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224795|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224796|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224797|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224798|NCT01292226|E1|Reported Event|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
224799|NCT01292187|B3|Baseline|Total|Total of all reporting groups
224800|NCT01292187|B2|Baseline|Placebo Tablets|Patients who did not receive any active treatment, just placebo
224801|NCT01292187|B1|Baseline|rsCT Tablets|Patients who received oral calcitonin as an active treatment
224802|NCT01292187|P2|Participant Flow|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
224803|NCT01292187|P1|Participant Flow|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
224804|NCT01292187|O2|Outcome|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
224805|NCT01292187|O1|Outcome|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
224806|NCT01292187|O2|Outcome|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
224807|NCT01292187|O1|Outcome|Oral Calcitonin Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
224808|NCT01292187|E2|Reported Event|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
224809|NCT01292187|E1|Reported Event|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
224810|NCT01292135|B3|Baseline|Total|Total of all reporting groups
224811|NCT01292135|B2|Baseline|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
224812|NCT01292135|B1|Baseline|PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)|PCI-32765: 420 mg daily
224813|NCT01292135|P2|Participant Flow|PCI-32765 Plus Bendamustine/Rituximab (BR)|"PCI-32765: 420 mg daily
BR:
Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1 (Cycle 2 to Cycle 6).
Bendamustine; 70 mg/m² on Day 1 and 2 of each cycle (Up to 6 Cycles)"
224814|NCT01292135|P1|Participant Flow|PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)|"PCI-32765: 420 mg daily
FCR:
Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1(Cycle 2 to Cycle 6).
Fludarabine: 25 mg/m2/day for 3 days (Days 1 to 3) of each cycle
Cyclophosphamide: 250 mg/m2/day for 3 days (Days 1 to 3) of each cycle (Up to 6 Cycle)"
224815|NCT01292135|O2|Outcome|PCI- 32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
224820|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
224821|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
224822|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
224823|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI- 32765: 420 mg daily
224824|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
224825|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI- 32765: 420 mg daily
224826|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
224827|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
224828|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
224829|NCT01292135|E2|Reported Event|PCI-32765 Plus Fludarabine/ Cyclophosphamide/Rituximab (FCR)|PCI-32765: 420 mg daily
224830|NCT01292135|E1|Reported Event|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
224831|NCT01292070|B1|Baseline|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
224832|NCT01292070|P1|Participant Flow|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
224833|NCT01292070|O1|Outcome|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
224834|NCT01292070|E1|Reported Event|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
224835|NCT01292057|B3|Baseline|Total|Total of all reporting groups
224836|NCT01292057|B2|Baseline|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
224837|NCT01292057|B1|Baseline|Aripiprazole|"Medication
Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
224838|NCT01292057|P2|Participant Flow|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
224839|NCT01292057|P1|Participant Flow|Aripiprazole|"Medication
Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
224840|NCT01292057|O2|Outcome|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
224841|NCT01292057|O1|Outcome|Aripiprazole|"Medication
Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
224842|NCT01292057|O2|Outcome|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
224843|NCT01292057|O1|Outcome|Aripiprazole|"Medication
Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
224844|NCT01292057|E2|Reported Event|Sugar Pill|Placebo: Placebo to match active drug Aripiprazole for 8 days
224845|NCT01292057|E1|Reported Event|Aripiprazole|"Medication
Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days"
224846|NCT01292005|B3|Baseline|Total|Total of all reporting groups
224847|NCT01292005|B2|Baseline|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224848|NCT01292005|B1|Baseline|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224849|NCT01292005|P2|Participant Flow|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224850|NCT01292005|P1|Participant Flow|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224851|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224852|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
225972|NCT01289028|O1|Outcome|Nilotinib|
224853|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224854|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224855|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224856|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224857|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224858|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224859|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224860|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224861|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224862|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224863|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224864|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224865|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224866|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224867|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224868|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224869|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224870|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224871|NCT01292005|E2|Reported Event|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224872|NCT01292005|E1|Reported Event|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
224873|NCT01291784|B1|Baseline|Phase 1 MF Subjects|3 subjects were enrolled in the study. The three subjects were treated at a GC1008 dose level of 1 mg/kg given intravenously over approximately 60 minutes and then repeated every 28 days for a total of 6 cycles in the core study period and then an additional 6 cycles in an extension phase.
224874|NCT01291784|P3|Participant Flow|Sub C|Subject C
224875|NCT01291784|P2|Participant Flow|Sub B|Subject B
224876|NCT01291784|P1|Participant Flow|Sub A|Subject A
224877|NCT01291784|O3|Outcome|Sub C|Subject C
224878|NCT01291784|O2|Outcome|Sub B|Subject B
224879|NCT01291784|O1|Outcome|Sub A|Subject A
224880|NCT01291784|O3|Outcome|Sub C|Subject C
224881|NCT01291784|O2|Outcome|Sub B|Subject B
224882|NCT01291784|O1|Outcome|Sub A|Subject A
224883|NCT01291784|O3|Outcome|Sub C|Subject C
224884|NCT01291784|O2|Outcome|Sub B|Subject B
224885|NCT01291784|O1|Outcome|Sub A|Subject A
224886|NCT01291784|O3|Outcome|Sub C|Subject C
224887|NCT01291784|O2|Outcome|Sub B|Subject B
224888|NCT01291784|O1|Outcome|Sub A|Subject A
224889|NCT01291784|O3|Outcome|Sub C|Subject C
224890|NCT01291784|O2|Outcome|Sub B|Subject B
224891|NCT01291784|O1|Outcome|Sub A|Subject A
224892|NCT01291784|E3|Reported Event|Sub C|Subject C
224893|NCT01291784|E2|Reported Event|Sub B|Subject B
224894|NCT01291784|E1|Reported Event|Sub A|Subject A
224895|NCT01291498|B1|Baseline|HIFU Treatment|This is a single arm study, all subjects are planned to received HIFU treatment
224896|NCT01291498|P1|Participant Flow|HIFU Treatment|This is a single arm study, all subjects are planned to receive HIFU treatment
224897|NCT01291498|O1|Outcome|HIFU Treatment|Allsubjects are planned to have HIFU Treatment
224898|NCT01291498|O1|Outcome|HIFU Treatment|Ablation of the parathyroid gland by HIFU Treatment
224899|NCT01291498|O1|Outcome|HIFU Treatment|This is a single arm study, all subjects are planned to receive HIFU treatment
224900|NCT01291498|E1|Reported Event|HIFU Treatment|This is a single arm study, all subjects are planned to received HIFU treatment
224901|NCT01291277|B3|Baseline|Total|Total of all reporting groups
224902|NCT01291277|B2|Baseline|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals
Endoscopic Variceal Ligation: Ligation of esophageal varices"
224903|NCT01291277|B1|Baseline|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals
Endoscopic Variceal Ligation: Ligation of esophageal varices"
224904|NCT01291277|P2|Participant Flow|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals
Endoscopic Variceal Ligation: Ligation of esophageal varices"
225973|NCT01289028|E1|Reported Event|All Patients|All patients
224905|NCT01291277|P1|Participant Flow|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals
Endoscopic Variceal Ligation: Ligation of esophageal varices"
224906|NCT01291277|O2|Outcome|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals
Endoscopic Variceal Ligation: Ligation of esophageal varices"
224907|NCT01291277|O1|Outcome|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals
Endoscopic Variceal Ligation: Ligation of esophageal varices"
224908|NCT01291277|E2|Reported Event|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals
Endoscopic Variceal Ligation: Ligation of esophageal varices"
224909|NCT01291277|E1|Reported Event|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals
Endoscopic Variceal Ligation: Ligation of esophageal varices"
224910|NCT01291264|B1|Baseline|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
224911|NCT01291264|P1|Participant Flow|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
224912|NCT01291264|O1|Outcome|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
224913|NCT01291264|E1|Reported Event|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
224914|NCT01291225|B3|Baseline|Total|Total of all reporting groups
224915|NCT01291225|B2|Baseline|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
224916|NCT01291225|B1|Baseline|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
224917|NCT01291225|P2|Participant Flow|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
224918|NCT01291225|P1|Participant Flow|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
224919|NCT01291225|O4|Outcome|Farms--Pickaway/Morrow Counties|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
224920|NCT01291225|O3|Outcome|Farms--Ross County|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
224921|NCT01291225|O2|Outcome|Playground--Circleville|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
224922|NCT01291225|O1|Outcome|Playground--Chillicothe|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
224923|NCT01291225|O2|Outcome|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
224924|NCT01291225|O1|Outcome|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
224925|NCT01291225|E2|Reported Event|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
224926|NCT01291225|E1|Reported Event|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
224927|NCT01291173|B5|Baseline|Total|Total of all reporting groups
224928|NCT01291173|B4|Baseline|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224929|NCT01291173|B3|Baseline|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224930|NCT01291173|B2|Baseline|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224931|NCT01291173|B1|Baseline|Placebo|Placebo capsule taken once daily for up to 11 weeks
224932|NCT01291173|P4|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224933|NCT01291173|P3|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224934|NCT01291173|P2|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224935|NCT01291173|P1|Participant Flow|Placebo|Placebo capsule taken once daily for up to 11 weeks
224936|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224937|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224938|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224939|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224940|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224941|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224942|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224943|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224944|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224945|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224946|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224947|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224948|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224949|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
225974|NCT01289015|B3|Baseline|Total|Total of all reporting groups
224950|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224951|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224952|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224953|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224954|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224955|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224956|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224957|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224958|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224959|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224960|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224961|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224962|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224963|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224964|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224965|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224966|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224967|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224968|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224969|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224970|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224971|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224972|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224973|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224974|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224975|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224976|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224977|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224978|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224979|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224980|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224981|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224982|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224983|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224984|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224985|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224986|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224987|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224988|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224989|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224990|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224991|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
224992|NCT01291173|E4|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
224993|NCT01291173|E3|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
224994|NCT01291173|E2|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
224995|NCT01291173|E1|Reported Event|Placebo|Placebo capsule taken once daily for up to 11 weeks
224996|NCT01291160|B3|Baseline|Total|Total of all reporting groups
224997|NCT01291160|B2|Baseline|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.
Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
225016|NCT01291108|O3|Outcome|Combined Adjunctives|Combined adjunctives refer to the combined groups of ’AGN-210669 0.05% + bimatoprost’ and ’bimatoprost + AGN-210669 0.05%’. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
225975|NCT01289015|B2|Baseline|Placebo|Placebo : Topical; applied once daily for two weeks
224998|NCT01291160|B1|Baseline|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.
Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
224999|NCT01291160|P2|Participant Flow|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.
Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
225000|NCT01291160|P1|Participant Flow|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.
Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
225001|NCT01291160|O2|Outcome|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.
Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
225002|NCT01291160|O1|Outcome|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.
Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
225003|NCT01291160|E2|Reported Event|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.
Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
225004|NCT01291160|E1|Reported Event|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.
Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
225005|NCT01291108|B5|Baseline|Total|Total of all reporting groups
225006|NCT01291108|B4|Baseline|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.
225007|NCT01291108|B3|Baseline|Bimatoprost Followed by Bimatoprost + AGN-210669|bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + AGN-210669 applied as 1 drop of each treatment in both eyes every evening for Month 2.
225008|NCT01291108|B2|Baseline|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.
225009|NCT01291108|B1|Baseline|AGN-210669 Followed by AGN-210669 + Bimatoprost|AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
225010|NCT01291108|P6|Participant Flow|Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
225011|NCT01291108|P5|Participant Flow|Bimatoprost + AGN-210669|bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
225012|NCT01291108|P4|Participant Flow|Bimatoprost|bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
225013|NCT01291108|P3|Participant Flow|AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
225014|NCT01291108|P2|Participant Flow|AGN-210669 + Bimatoprost|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
225015|NCT01291108|P1|Participant Flow|AGN-210669|AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
225976|NCT01289015|B1|Baseline|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
225017|NCT01291108|O2|Outcome|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
225018|NCT01291108|O1|Outcome|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
225019|NCT01291108|O3|Outcome|Combined Adjunctives|Combined adjunctives refer to the combined groups of ’AGN-210669 0.05% + bimatoprost’ and ’bimatoprost + AGN-210669 0.05%’. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
225020|NCT01291108|O2|Outcome|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
225021|NCT01291108|O1|Outcome|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
225022|NCT01291108|E6|Reported Event|Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
225023|NCT01291108|E5|Reported Event|Bimatoprost + AGN-210669|bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
225024|NCT01291108|E4|Reported Event|Bimatoprost|bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
225025|NCT01291108|E3|Reported Event|AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
225026|NCT01291108|E2|Reported Event|AGN-210669 + Bimatoprost|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
225027|NCT01291108|E1|Reported Event|AGN-210669|AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
225028|NCT01291056|B3|Baseline|Total|Total of all reporting groups
225029|NCT01291056|B2|Baseline|Placebo, Then Clomiphene Citrate|Placebo, then Clomiphene Citrate 50 milligrams daily
225030|NCT01291056|B1|Baseline|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
225031|NCT01291056|P2|Participant Flow|Placebo, Then Clomiphene Citrate|Placebo, then Clomiphene Citrate 50 milligrams daily
225032|NCT01291056|P1|Participant Flow|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
225033|NCT01291056|O2|Outcome|Placebo|Placebo
225034|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
225035|NCT01291056|O2|Outcome|Placebo|Placebo
225036|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
225037|NCT01291056|O2|Outcome|Placebo|Placebo
225038|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
225039|NCT01291056|O2|Outcome|Placebo|Placebo
225040|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
225041|NCT01291056|E2|Reported Event|Placebo, Then Clomiphene Citrate|Placebo daily, then Clomiphene Citrate 50 milligrams daily
225042|NCT01291056|E1|Reported Event|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
225043|NCT01291017|B1|Baseline|PD0332991|"PD0332991 125 mg PO days 1 - 21
PD0332991: PD0332991 125 mg PO days 1 - 21"
225044|NCT01291017|P1|Participant Flow|PD0332991|"PD0332991 125 mg PO days 1 - 21
PD0332991: PD0332991 125 mg PO days 1 - 21"
225045|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21
PD0332991: PD0332991 125 mg PO days 1 - 21"
225046|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21
PD0332991: PD0332991 125 mg PO days 1 - 21"
225047|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21
PD0332991: PD0332991 125 mg PO days 1 - 21"
225048|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21
PD0332991: PD0332991 125 mg PO days 1 - 21"
225049|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21
PD0332991: PD0332991 125 mg PO days 1 - 21"
225050|NCT01291017|E1|Reported Event|PD0332991|"PD0332991 125 mg PO days 1 - 21
PD0332991: PD0332991 125 mg PO days 1 - 21"
225051|NCT01290978|B1|Baseline|ChloraPrep , DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
225052|NCT01290978|P1|Participant Flow|ChloraPrep, DuraPrep|Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule
225053|NCT01290978|O2|Outcome|DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
225054|NCT01290978|O1|Outcome|ChloraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
225055|NCT01290978|O2|Outcome|DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
225056|NCT01290978|O1|Outcome|ChloraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
225057|NCT01290978|E1|Reported Event|ChloraPrep, DuraPrep|Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule
225058|NCT01290952|B3|Baseline|Total|Total of all reporting groups
225059|NCT01290952|B2|Baseline|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
225060|NCT01290952|B1|Baseline|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
225061|NCT01290952|P2|Participant Flow|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
225062|NCT01290952|P1|Participant Flow|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
225063|NCT01290952|O2|Outcome|Off-pump Bypass Surgery|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
225064|NCT01290952|O1|Outcome|On-pump Bypass Surgery|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
225065|NCT01290952|O2|Outcome|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
225066|NCT01290952|O1|Outcome|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
225067|NCT01290952|E2|Reported Event|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
225068|NCT01290952|E1|Reported Event|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
225069|NCT01290913|B1|Baseline|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
225070|NCT01290913|P1|Participant Flow|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
225071|NCT01290913|O1|Outcome|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
225072|NCT01290913|O1|Outcome|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
225073|NCT01290913|E1|Reported Event|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
225074|NCT01290887|B3|Baseline|Total|Total of all reporting groups
225075|NCT01290887|B2|Baseline|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225076|NCT01290887|B1|Baseline|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225077|NCT01290887|P2|Participant Flow|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225078|NCT01290887|P1|Participant Flow|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225079|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225080|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225081|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225082|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225083|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225084|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225085|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225086|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225087|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225281|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225088|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225089|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225090|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225091|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225092|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225093|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225094|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225095|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225096|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225097|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225098|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225099|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225100|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225101|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225102|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225103|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225104|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225105|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225106|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225107|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225108|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225109|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225110|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225111|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225112|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225113|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
225114|NCT01290887|E1|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
225282|NCT01290627|O3|Outcome|Control|Subjects with normal knees
225115|NCT01290822|B1|Baseline|All Subjects in the Study|"This includes all subjects in the study. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied."
225116|NCT01290822|P1|Participant Flow|All Subjects in the Study|"This includes all subjects in the study. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied."
225117|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
225118|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
225119|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
225120|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
225121|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
225122|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
225123|NCT01290822|E1|Reported Event|All Subjects in the Study|This includes all subjects in the study
225124|NCT01290796|B1|Baseline|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225125|NCT01290796|P1|Participant Flow|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225126|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225127|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225128|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225129|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225130|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225131|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225132|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225133|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225134|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225783|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225135|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225136|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225137|NCT01290796|E1|Reported Event|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling
Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
225138|NCT01290757|B3|Baseline|Total|Total of all reporting groups
225139|NCT01290757|B2|Baseline|Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps|Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR)
225140|NCT01290757|B1|Baseline|Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel|Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT)
225141|NCT01290757|P2|Participant Flow|Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps|Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR)
225142|NCT01290757|P1|Participant Flow|Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel|Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT)
225143|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
225144|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
225145|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
225146|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
225147|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
225148|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
225149|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
225150|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
225151|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
225152|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
225153|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
225154|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
225155|NCT01290757|E2|Reported Event|Capsugel|Dabigatran 150mg in Capsugel
225156|NCT01290757|E1|Reported Event|Qualicaps|Dabigatran 150mg in Qualicaps
225157|NCT01290731|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225158|NCT01290731|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225159|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225160|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225161|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225162|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225283|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225163|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225164|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225165|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225166|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225167|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225168|NCT01290731|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
225169|NCT01290718|B1|Baseline|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
225170|NCT01290718|P1|Participant Flow|Capecitabine Plus (+) Trastuzumab|Participants received capecitabine 900 milligrams per square meter (mg/m^2) orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
225171|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
225172|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
225173|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
225174|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
225175|NCT01290718|E1|Reported Event|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
225176|NCT01290679|B3|Baseline|Total|Total of all reporting groups
225177|NCT01290679|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225178|NCT01290679|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225179|NCT01290679|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225180|NCT01290679|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225181|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225304|NCT01290536|O1|Outcome|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
225182|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225183|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225184|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225185|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225186|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225187|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225188|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225189|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225190|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225191|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225192|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225193|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225194|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225195|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225196|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225197|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225198|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225199|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225200|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225305|NCT01290536|E1|Reported Event|Yttrium-90 Liver Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
225201|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225202|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225203|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225204|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225205|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225206|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225207|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225208|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225209|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225210|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225211|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225212|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225213|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225214|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225215|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225216|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225217|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225218|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225219|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225220|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225801|NCT01289418|B2|Baseline|Health Care Workers in Toronto|Health Care Workers from Toronto
225221|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225222|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225223|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225224|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225225|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225226|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225227|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225228|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225229|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225230|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225231|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225232|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225233|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225234|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225235|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225236|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225237|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225238|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225239|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225240|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225802|NCT01289418|B1|Baseline|Health Care Workers in Quebec|Health care workers from Quebec
225241|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225242|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225243|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225244|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225245|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225246|NCT01290679|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
225247|NCT01290679|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225248|NCT01290666|B1|Baseline|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.
Fistula Plug: Bioabsorbable fistula plug"
225249|NCT01290666|P1|Participant Flow|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.
Fistula Plug: Bioabsorbable fistula plug"
225250|NCT01290666|O1|Outcome|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.
Fistula Plug: Bioabsorbable fistula plug"
225251|NCT01290666|E1|Reported Event|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.
Fistula Plug: Bioabsorbable fistula plug"
225252|NCT01290640|B3|Baseline|Total|Total of all reporting groups
225253|NCT01290640|B2|Baseline|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|
225254|NCT01290640|B1|Baseline|PFC RP TC3 TKA|
225255|NCT01290640|P2|Participant Flow|Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA|
225256|NCT01290640|P1|Participant Flow|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|Subjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA
225257|NCT01290640|O2|Outcome|Subjects With DePuy PFC Fixed Bearing TC3 TKA|
225258|NCT01290640|O1|Outcome|Subjects With DePuy PFC Rotating Platform TC3 TKA|
225259|NCT01290640|O2|Outcome|Subjects With DePuy PFC Fixed Bearing TC3 TKA|
225260|NCT01290640|O1|Outcome|Subjects With DePuy PFC Rotating Platform TC3 TKA|
225261|NCT01290640|E2|Reported Event|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|
225262|NCT01290640|E1|Reported Event|Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA|
225263|NCT01290627|B4|Baseline|Total|Total of all reporting groups
225264|NCT01290627|B3|Baseline|Control|Subjects with normal knees
225265|NCT01290627|B2|Baseline|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225266|NCT01290627|B1|Baseline|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225267|NCT01290627|P3|Participant Flow|Control|Subjects with normal knees
225268|NCT01290627|P2|Participant Flow|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225269|NCT01290627|P1|Participant Flow|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225270|NCT01290627|O3|Outcome|Control|Subjects with normal knees
225271|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225272|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225273|NCT01290627|O3|Outcome|Control|Subjects with normal knees
225274|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225275|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225276|NCT01290627|O3|Outcome|Control|Subjects with normal knees
225277|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225278|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225279|NCT01290627|O3|Outcome|Control|Subjects with normal knees
225280|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225284|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225285|NCT01290627|E3|Reported Event|Control|Subjects with normal knees
225286|NCT01290627|E2|Reported Event|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225287|NCT01290627|E1|Reported Event|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
225288|NCT01290614|B3|Baseline|Total|Total of all reporting groups
225289|NCT01290614|B2|Baseline|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.
Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
225290|NCT01290614|B1|Baseline|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
225291|NCT01290614|P2|Participant Flow|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.
Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
225292|NCT01290614|P1|Participant Flow|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
225293|NCT01290614|O2|Outcome|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.
Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
225294|NCT01290614|O1|Outcome|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
225295|NCT01290614|O2|Outcome|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.
Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
225296|NCT01290614|O1|Outcome|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
225297|NCT01290614|E2|Reported Event|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.
Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
225298|NCT01290614|E1|Reported Event|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
225299|NCT01290536|B1|Baseline|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
225300|NCT01290536|P1|Participant Flow|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
225301|NCT01290536|O3|Outcome|Other Tumors - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
225302|NCT01290536|O2|Outcome|Neuroendocrine - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
225303|NCT01290536|O1|Outcome|Colorectal - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
225803|NCT01289418|P1|Participant Flow|Health Care Workers|Health care workers from all hospitals
225306|NCT01290523|B1|Baseline|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)
Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
225307|NCT01290523|P1|Participant Flow|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)
Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
225308|NCT01290523|O1|Outcome|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)
Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
225309|NCT01290523|O1|Outcome|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)
Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
225310|NCT01290523|E1|Reported Event|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)
Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
225311|NCT01290484|B1|Baseline|Sildenafil|Male and female subjects between the ages of 6 months and 10 years, weighing at least 8 kg and had been given a diagnosis of a lymphatic malformation of at least 3 cm based on clinical and radiologic criteria. Macrocystic, microcystic, or mixed lymphatic malformations involving any location on the body were included. Lymphatic malformations associated with an incomplete response to previous treatments, a risk of functional or aesthetic impairment, or local complications were included.
225312|NCT01290484|P1|Participant Flow|Sildenafil|Participants were given sildenafil for 20 weeks. Participants weighing more than 20 kg were given 20 mg 3 times daily (60 mg/day). Participants weighing between 8 kg and 20 kg were given 10 mg 3 times daily (30 mg/day).
225313|NCT01290484|O1|Outcome|Sildenafil|The primary outcome was the effect of sildenafil on lymphatic malformation volume. Response to sildenafil was characterized by any decrease in lymphatic malformation volume. Lymphatic malformations volumes were assessed blindly by MRI volume segmentation analysis at baseline and after 20 weeks of sildenafil. 4 subjects had a lymphatic malformation volume decrease.
225314|NCT01290484|E1|Reported Event|Sildenafil|Adverse events reported while one sildenafil were minimal. All subjects tolerated the prescribed medication dose. One subject developed an upper respiratory tract infection and experienced temporary hearing loss due to fluid accumulation. This was resolved completely and she experienced no further hearing loss while on sildenafil. Four parents requested to have the child continue sildenafil after study completion.
225315|NCT01290341|B3|Baseline|Total|Total of all reporting groups
225316|NCT01290341|B2|Baseline|Placebo|Topical; applied once daily for two weeks.
225317|NCT01290341|B1|Baseline|NAFT-600|Topical; applied once daily for two weeks
225318|NCT01290341|P2|Participant Flow|Placebo|Topical; applied once daily for two weeks.
225319|NCT01290341|P1|Participant Flow|NAFT-600|Topical; applied once daily for two weeks
225320|NCT01290341|O2|Outcome|Placebo|Topical; applied once daily for two weeks.
225321|NCT01290341|O1|Outcome|NAFT-600|Topical; applied once daily for two weeks
225322|NCT01290341|O2|Outcome|Placebo|Topical; applied once daily for two weeks.
225323|NCT01290341|O1|Outcome|NAFT-600|Topical; applied once daily for two weeks
225324|NCT01290341|E2|Reported Event|Placebo|Topical; applied once daily for two weeks.
225325|NCT01290341|E1|Reported Event|NAFT-600|Topical; applied once daily for two weeks
225326|NCT01290263|B3|Baseline|Total|Total of all reporting groups
225327|NCT01290263|B2|Baseline|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
225328|NCT01290263|B1|Baseline|Cohort B: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
225329|NCT01290263|P5|Participant Flow|All Cohort B Participants: AMG 386 + Bevacizumab|Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
225330|NCT01290263|P4|Participant Flow|Cohort B Phase II: AMG 386 30 mg/kg + Bevacizumab|Participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the maximum tolerated AMG 386 dose established in the Phase I Cohort B study, AMG 386 of 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
225331|NCT01290263|P3|Participant Flow|Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab|"Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg + kg."
225332|NCT01290263|P2|Participant Flow|Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab|Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
225333|NCT01290263|P1|Participant Flow|Cohort A: AMG 386 30 mg/kg|Cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
225366|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
225804|NCT01289418|O1|Outcome|Health Care Workers From CHUQ Hospitals|
225334|NCT01290263|O2|Outcome|Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab|"Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg/kg."
225335|NCT01290263|O1|Outcome|Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab|Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
225336|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
225337|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
225338|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
225339|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
225340|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
225341|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
225342|NCT01290263|O2|Outcome|Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab|"Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg/kg."
225343|NCT01290263|O1|Outcome|Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab|Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
225344|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
225345|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
225346|NCT01290263|E2|Reported Event|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
225347|NCT01290263|E1|Reported Event|Cohort B: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
225348|NCT01290224|B1|Baseline|Sham Procedure + Scrambler Treatment|
225349|NCT01290224|P1|Participant Flow|Sham Procedure + Scrambler Treatment|
225350|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
225351|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
225352|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
225353|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
225354|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
225355|NCT01290224|O2|Outcome|Scrambler Therapy (Day 2)|
225356|NCT01290224|O1|Outcome|Sham Procedure (Day 1 )|
225357|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
225358|NCT01290224|E1|Reported Event|Sham Procedure + Scrambler Treatment|
225359|NCT01290094|B1|Baseline|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
225360|NCT01290094|P1|Participant Flow|Ibandronate|Participants received 3 milligrams (mg) ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
225361|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
225362|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
225363|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
225364|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
225365|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
225739|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225367|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
225368|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
225369|NCT01290094|E1|Reported Event|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for 9 months (total of 4 injections).
225370|NCT01290068|B3|Baseline|Total|Total of all reporting groups
225371|NCT01290068|B2|Baseline|Monofocal IOL|Monofocal IOL, bilateral implantation
225372|NCT01290068|B1|Baseline|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
225373|NCT01290068|P2|Participant Flow|Monofocal IOL|Monofocal IOL, bilateral implantation
225374|NCT01290068|P1|Participant Flow|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
225375|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
225376|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
225377|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
225378|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
225379|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
225380|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
225381|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
225382|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
225383|NCT01290068|E2|Reported Event|Monofocal IOL|Monofocal IOL, bilateral implantation
225384|NCT01290068|E1|Reported Event|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
225385|NCT01290029|B1|Baseline|Cinacalcet 0.25 mg/kg|Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225386|NCT01290029|P1|Participant Flow|Cinacalcet 0.25 mg/kg|Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225387|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225388|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225389|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225390|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225391|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225392|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225393|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225394|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225395|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225396|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225397|NCT01290029|E1|Reported Event|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
225398|NCT01289990|B14|Baseline|Total|Total of all reporting groups
225399|NCT01289990|B13|Baseline|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching Empagliflozin
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg"
225400|NCT01289990|B12|Baseline|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg"
225401|NCT01289990|B11|Baseline|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Empagliflozin 10 mg tablets once daily
Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg"
225402|NCT01289990|B10|Baseline|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching Empagliflozin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg"
225403|NCT01289990|B9|Baseline|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg"
225404|NCT01289990|B8|Baseline|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23
Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg
Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
225405|NCT01289990|B7|Baseline|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching Empagliflozin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg"
225406|NCT01289990|B6|Baseline|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg"
225407|NCT01289990|B5|Baseline|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19
Empagliflozin 10 mg tablets once daily
Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg"
225408|NCT01289990|B4|Baseline|Sitagliptin 100 mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching Empagliflozin 25 mg
Placebo: Placebo matching Empagliflozin 10 mg
Sitagliptin 100 mg: Sitagliptin once daily"
225409|NCT01289990|B3|Baseline|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching Empagliflozin / Sitagliptin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching Empagliflozin 25 mg"
225805|NCT01289418|O1|Outcome|Health Care Workers|Health care workers with a valid email address
225410|NCT01289990|B2|Baseline|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20
Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Sitagliptin
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg"
225411|NCT01289990|B1|Baseline|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20
Empagliflozin 10 mg tablets once daily
Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching Empagliflozin 25 mg"
225412|NCT01289990|P13|Participant Flow|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching Empagliflozin
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg"
225413|NCT01289990|P12|Participant Flow|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg"
225414|NCT01289990|P11|Participant Flow|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Empagliflozin 10 mg tablets once daily
Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg"
225415|NCT01289990|P10|Participant Flow|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching Empagliflozin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg"
225416|NCT01289990|P9|Participant Flow|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg"
225417|NCT01289990|P8|Participant Flow|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23
Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg
Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
225418|NCT01289990|P7|Participant Flow|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching Empagliflozin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg"
225419|NCT01289990|P6|Participant Flow|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg"
225420|NCT01289990|P5|Participant Flow|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19
Empagliflozin 10 mg tablets once daily
Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg"
225421|NCT01289990|P4|Participant Flow|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching Empagliflozin 25 mg
Placebo: Placebo matching Empagliflozin 10 mg
Sitagliptin 100mg: Sitagliptin once daily"
225422|NCT01289990|P3|Participant Flow|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching Empagliflozin / Sitagliptin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching Empagliflozin 25 mg"
225423|NCT01289990|P2|Participant Flow|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20
Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching Empagliflozin 10 mg"
225424|NCT01289990|P1|Participant Flow|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20
Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching Empagliflozin 25 mg"
225425|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225426|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225427|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225428|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225429|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225430|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225431|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225432|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225433|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225434|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225435|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225436|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225437|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225438|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
228201|NCT01283516|E5|Reported Event|LDK378 400 mg|LDK378 400 mg
225439|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225440|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225441|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225442|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225443|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225444|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225445|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225446|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225447|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225448|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225449|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225450|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225451|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225452|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225453|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225454|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225455|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225456|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225457|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225458|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225459|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225460|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225461|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225462|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225463|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225464|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225465|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225466|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225467|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225468|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225469|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
228202|NCT01283516|E4|Reported Event|LDK378 300 mg|LDK378 300 mg
225470|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225471|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225472|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225473|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225474|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225475|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225476|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225477|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225478|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225479|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225480|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225481|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225482|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225483|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225484|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225485|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225486|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225487|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225488|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225489|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225490|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225491|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225492|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225493|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225494|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225495|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225496|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225497|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225498|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225499|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225500|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225501|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225502|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225503|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225504|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225505|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225506|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225507|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225508|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225509|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225510|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225511|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225512|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225513|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225514|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225515|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225516|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225517|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225518|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225519|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225520|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225521|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225522|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225523|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225524|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225525|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225526|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225527|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225528|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225529|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225530|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225531|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225532|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225533|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225534|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225535|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225536|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225537|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225538|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225539|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225540|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225541|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225542|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225543|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225544|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225545|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225546|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225547|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225548|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225549|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225550|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225551|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225552|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225553|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225554|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225555|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225556|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225557|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225558|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225559|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225560|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225561|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225562|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
228203|NCT01283516|E3|Reported Event|LDK378 200 mg|LDK378 200 mg
225563|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225564|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225565|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225566|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225567|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225568|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225569|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225570|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225571|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225572|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225573|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225574|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225575|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225576|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225577|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225578|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225579|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225580|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225581|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225582|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225583|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225584|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225585|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225586|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23
BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose
BI 10773: BI 10773 tablets once daily"
225587|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching BI 10773 once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching BI 10773 high dose"
225588|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225589|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 high dose"
225590|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching BI 10773 high dose
Placebo: Placebo matching BI 10773 low dose
Sitagliptin 100mg: Sitagliptin once daily"
225591|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching BI 10773 / Sitagliptin once daily
Placebo: Placebo matching BI 10773 low dose
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225592|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching BI 10773 low dose"
225740|NCT01289574|O1|Outcome|Vehicle Control Cream|Vehicle control cream for twice daily topical application to the face
225593|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20
BI 10773 tablets once daily
BI 10773: BI 10773 tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching BI 10773 high dose"
225594|NCT01289990|E13|Reported Event|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from 1245.23
Placebo tablets matching Empagliflozin
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg"
225595|NCT01289990|E12|Reported Event|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg"
225596|NCT01289990|E11|Reported Event|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23
Empagliflozin 10 mg tablets once daily
Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg"
225597|NCT01289990|E10|Reported Event|Placebo (Metformin)|"Patients rolled over from trial 1245.23
Placebo tablets matching Empagliflozin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg"
225598|NCT01289990|E9|Reported Event|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg"
225599|NCT01289990|E8|Reported Event|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23
Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg
Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
225600|NCT01289990|E7|Reported Event|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19
Placebo tablets matching Empagliflozin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg"
225601|NCT01289990|E6|Reported Event|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg"
225602|NCT01289990|E5|Reported Event|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19
Empagliflozin 10 mg tablets once daily
Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg"
225603|NCT01289990|E4|Reported Event|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching Empagliflozin 25 mg
Placebo: Placebo matching Empagliflozin 10 mg
Sitagliptin 100mg: Sitagliptin once daily"
225604|NCT01289990|E3|Reported Event|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20
Placebo tablets matching Empagliflozin / Sitagliptin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching Empagliflozin 25 mg"
225605|NCT01289990|E2|Reported Event|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20
Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching Empagliflozin 10 mg"
225606|NCT01289990|E1|Reported Event|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20
Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching Empagliflozin 25 mg"
225607|NCT01289847|B1|Baseline|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
225608|NCT01289847|P1|Participant Flow|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
225609|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
225610|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
225611|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
225612|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
225613|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
225614|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
225615|NCT01289847|E1|Reported Event|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
225616|NCT01289821|B1|Baseline|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
225617|NCT01289821|P1|Participant Flow|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
225741|NCT01289574|E3|Reported Event|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225742|NCT01289574|E2|Reported Event|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225618|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
225619|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
225620|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
225621|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
225622|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
225623|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
225624|NCT01289821|E1|Reported Event|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
225625|NCT01289782|B3|Baseline|Total|Total of all reporting groups
225626|NCT01289782|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225627|NCT01289782|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225628|NCT01289782|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225629|NCT01289782|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225630|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225631|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225632|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225743|NCT01289574|E1|Reported Event|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
225744|NCT01289548|B4|Baseline|Total|Total of all reporting groups
225806|NCT01289418|O1|Outcome|Health Care Workers|Health care workers with a valid e-mail address
225807|NCT01289418|E1|Reported Event|Health Care Workers From CHUQ Hospitals|
225633|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225634|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225635|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225636|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225637|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225638|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225639|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225640|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225641|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225642|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225643|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225644|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225645|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225646|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225647|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225648|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225649|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225650|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225651|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225745|NCT01289548|B3|Baseline|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225808|NCT01289392|B4|Baseline|Total|Total of all reporting groups
225652|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225653|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225654|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225655|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225656|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225657|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225658|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225659|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225660|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225661|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225662|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225663|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225664|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225665|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225666|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225667|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225668|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225669|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225670|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225671|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225746|NCT01289548|B2|Baseline|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225672|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225673|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225674|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225675|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225676|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225677|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225678|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225679|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225680|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225681|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225682|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225683|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225684|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225685|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225686|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225687|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225688|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225689|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225690|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225691|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225747|NCT01289548|B1|Baseline|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225909|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225692|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225693|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225694|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225695|NCT01289782|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
225696|NCT01289782|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
225697|NCT01289639|B4|Baseline|Total|Total of all reporting groups
225698|NCT01289639|B3|Baseline|Arm 3|"pioglitazone 30 mg po qd
matching placebo for fenofibrate 1 po qd"
225699|NCT01289639|B2|Baseline|Arm 2|"micronized fenofibrate 200 mg 1 po qd
matching placebo for pioglitazone 1 po qd"
225700|NCT01289639|B1|Baseline|Arm 1|"matching placebo for fenofibrate 1 po qd
matching placebo for pioglitazone 1 po qd"
225701|NCT01289639|P3|Participant Flow|Arm 3|"pioglitazone 30 mg po qd
matching placebo for fenofibrate 1 po qd"
225702|NCT01289639|P2|Participant Flow|Arm 2|"micronized fenofibrate 200 mg 1 po qd
matching placebo for pioglitazone 1 po qd"
225703|NCT01289639|P1|Participant Flow|Arm 1|"matching placebo for fenofibrate 1 capsule po qd
matching placebo for pioglitazone 1 capsule po qd"
225704|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd
matching placebo for fenofibrate 1 po qd"
225705|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd
matching placebo for pioglitazone 1 po qd"
225706|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd
matching placebo for pioglitazone 1 capsule po qd"
225707|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd
matching placebo for fenofibrate 1 po qd"
225708|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd
matching placebo for pioglitazone 1 po qd"
225709|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd
matching placebo for pioglitazone 1 capsule po qd"
225710|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd
matching placebo for fenofibrate 1 po qd"
225711|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd
matching placebo for pioglitazone 1 po qd"
225712|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd
matching placebo for pioglitazone 1 capsule po qd"
225713|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd
matching placebo for fenofibrate 1 po qd"
225714|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd
matching placebo for pioglitazone 1 po qd"
225715|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd
matching placebo for pioglitazone 1 capsule po qd"
225716|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd
matching placebo for fenofibrate 1 po qd"
225717|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd
matching placebo for pioglitazone 1 po qd"
225718|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd
matching placebo for pioglitazone 1 capsule po qd"
225719|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd
matching placebo for fenofibrate 1 po qd"
225720|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd
matching placebo for pioglitazone 1 po qd"
225721|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd
matching placebo for pioglitazone 1 capsule po qd"
225722|NCT01289639|E3|Reported Event|Arm 3|"pioglitazone 30 mg po qd
matching placebo for fenofibrate 1 po qd"
225723|NCT01289639|E2|Reported Event|Arm 2|"micronized fenofibrate 200 mg 1 po qd
matching placebo for pioglitazone 1 po qd"
225724|NCT01289639|E1|Reported Event|Arm 1|"matching placebo for fenofibrate 1 capsule po qd
matching placebo for pioglitazone 1 capsule po qd"
225725|NCT01289574|B4|Baseline|Total|Total of all reporting groups
225726|NCT01289574|B3|Baseline|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225727|NCT01289574|B2|Baseline|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225728|NCT01289574|B1|Baseline|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
225729|NCT01289574|P3|Participant Flow|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225730|NCT01289574|P2|Participant Flow|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225731|NCT01289574|P1|Participant Flow|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
225732|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225733|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225734|NCT01289574|O1|Outcome|Vehicle Control Cream|Vehicle control cream for twice daily topical application to the face
225735|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225736|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225737|NCT01289574|O1|Outcome|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
225738|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
225748|NCT01289548|P3|Participant Flow|Recipient PIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225749|NCT01289548|P2|Participant Flow|Donor RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225750|NCT01289548|P1|Participant Flow|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
225751|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225752|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225753|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225754|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225755|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225756|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225757|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225758|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225759|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225760|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225761|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225762|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225763|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225764|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225765|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225766|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225767|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225768|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225769|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225770|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225771|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225772|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225773|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225774|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225775|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225776|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225777|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225778|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225779|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225780|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225781|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225782|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225784|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225785|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225786|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225787|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225788|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225789|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225790|NCT01289548|E3|Reported Event|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
225791|NCT01289548|E2|Reported Event|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
225792|NCT01289548|E1|Reported Event|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
225793|NCT01289522|B1|Baseline|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.
250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
500mg/m2 IV every 2 weeks during the maintenance therapy.
Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles
G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.
Biopsies: No intervention, only biopsy for translational project."
225794|NCT01289522|P1|Participant Flow|Cetuximab|"cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.
250 mg/m² over 60 minutes weekly on subsequent administrations
500mg/m2 every 2 weeks during the maintenance therapy. Drug: -Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles
Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles G-CSF support mandatory after each cycle of chemotherapy. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the 4th cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks."
225795|NCT01289522|O1|Outcome|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according
cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.
250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles
G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy.
Biopsies: No intervention, only biopsy for translational project."
225796|NCT01289522|O1|Outcome|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according
cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.
250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles
G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy.
Biopsies: No intervention, only biopsy for translational project."
225797|NCT01289522|O1|Outcome|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according
cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.
250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles
G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy.
Biopsies: No intervention, only biopsy for translational project."
225798|NCT01289522|E1|Reported Event|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.
250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
500mg/m2 IV every 2 weeks during the maintenance therapy.
Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles
G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.
Biopsies: No intervention, only biopsy for translational project."
225799|NCT01289418|B4|Baseline|Total|Total of all reporting groups
225800|NCT01289418|B3|Baseline|Health Care Workers in Halifax|Health Care Workers from Halifax
225809|NCT01289392|B3|Baseline|Physical Exercise|"Aerobic and resistance physical exercises
Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
225810|NCT01289392|B2|Baseline|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients
Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
225811|NCT01289392|B1|Baseline|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment
Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
225812|NCT01289392|P3|Participant Flow|Physical Exercise|"Aerobic and resistance physical exercises
Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
225813|NCT01289392|P2|Participant Flow|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients
Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
225814|NCT01289392|P1|Participant Flow|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment
Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
225815|NCT01289392|O3|Outcome|Physical Exercise|"Aerobic and resistance physical exercises
Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
225816|NCT01289392|O2|Outcome|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients
Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
225817|NCT01289392|O1|Outcome|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment
Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
225818|NCT01289392|E3|Reported Event|Physical Exercise|"Aerobic and resistance physical exercises
Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
225819|NCT01289392|E2|Reported Event|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients
Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
225820|NCT01289392|E1|Reported Event|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment
Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
225821|NCT01289210|B1|Baseline|VTX-2337 Plus Radiation|VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
225822|NCT01289210|P1|Participant Flow|VTX-2337 Plus Radiation|Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then administered weekly for 3 weeks in a 4 week cycle over 3 cycles.
225823|NCT01289210|O1|Outcome|VTX-2337 Plus Radiation|Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then admnistered weekly for 3 weeks in a 4 week cycle over 3 cycles.
225824|NCT01289210|E1|Reported Event|VTX-2337 Plus Radiation|VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
225825|NCT01289119|B7|Baseline|Total|Total of all reporting groups
225826|NCT01289119|B6|Baseline|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225827|NCT01289119|B5|Baseline|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225828|NCT01289119|B4|Baseline|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225829|NCT01289119|B3|Baseline|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225830|NCT01289119|B2|Baseline|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225831|NCT01289119|B1|Baseline|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225832|NCT01289119|P6|Participant Flow|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225833|NCT01289119|P5|Participant Flow|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225834|NCT01289119|P4|Participant Flow|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225835|NCT01289119|P3|Participant Flow|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225836|NCT01289119|P2|Participant Flow|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225837|NCT01289119|P1|Participant Flow|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225838|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225908|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225839|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225840|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225841|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225842|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225843|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225844|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225845|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225846|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225847|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225848|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225849|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225850|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225851|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225852|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225853|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225854|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225855|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225856|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225857|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225858|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225859|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225860|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225861|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225862|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225863|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225864|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225865|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225866|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225867|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225868|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225869|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225870|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225871|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225872|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225873|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225874|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225875|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225876|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225877|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225878|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225879|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225880|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225881|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225882|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225883|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225884|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225885|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225886|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225887|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225888|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225889|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225890|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225891|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225892|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225893|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225894|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225895|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225896|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225897|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225898|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225899|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225900|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225901|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225902|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225903|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225904|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225905|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225906|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225907|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225968|NCT01289028|O1|Outcome|Nilotinib|Per Protocol population
225910|NCT01289119|E6|Reported Event|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
225911|NCT01289119|E5|Reported Event|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225912|NCT01289119|E4|Reported Event|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225913|NCT01289119|E3|Reported Event|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
225914|NCT01289119|E2|Reported Event|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
225915|NCT01289119|E1|Reported Event|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
225916|NCT01289080|B3|Baseline|Total|Total of all reporting groups
225917|NCT01289080|B2|Baseline|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
225918|NCT01289080|B1|Baseline|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225919|NCT01289080|P2|Participant Flow|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
225920|NCT01289080|P1|Participant Flow|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225921|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
225922|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225923|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
225924|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225925|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
225926|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225927|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
225928|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225929|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
225930|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225931|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
225932|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225933|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
225934|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225935|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
225936|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225937|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole Day 1.
225938|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225939|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
225940|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225941|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
225942|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225943|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
225944|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225945|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole Day 1.
225946|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225947|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
225948|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
225949|NCT01289080|E1|Reported Event|Brexpiprazole 3mg|Participants with normal renal function and severe renal impairment were administered 3 mg brexpiprazole.
225950|NCT01289041|B1|Baseline|All Patients|
225951|NCT01289041|P1|Participant Flow|All Patients|
225952|NCT01289041|O3|Outcome|All Patients|
225953|NCT01289041|O2|Outcome|Non-Activated Pl3K|
225954|NCT01289041|O1|Outcome|Activated Pl3K|
225955|NCT01289041|O3|Outcome|All Patients|
225956|NCT01289041|O2|Outcome|Non-Activated Pl3K|
225957|NCT01289041|O1|Outcome|Activated Pl3K|
225958|NCT01289041|O3|Outcome|All Patients|
225959|NCT01289041|O2|Outcome|Non-Activated Pl3K|
225960|NCT01289041|O1|Outcome|Activated Pl3K|
225961|NCT01289041|E1|Reported Event|All Patients|
225962|NCT01289028|B1|Baseline|Nilotinib|
225963|NCT01289028|P1|Participant Flow|Nilotinib|
225964|NCT01289028|O1|Outcome|Nilotinib|
225965|NCT01289028|O1|Outcome|Nilotinib|
225966|NCT01289028|O1|Outcome|Nilotinib|
225967|NCT01289028|O1|Outcome|Nilotinib|
225977|NCT01289015|P2|Participant Flow|Placebo|Placebo : Topical; applied once daily for two weeks
225978|NCT01289015|P1|Participant Flow|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
225979|NCT01289015|O2|Outcome|Placebo|Placebo : Topical; applied once daily for two weeks
225980|NCT01289015|O1|Outcome|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
225981|NCT01289015|O2|Outcome|Placebo|Placebo : Topical; applied once daily for two weeks
225982|NCT01289015|O1|Outcome|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
225983|NCT01289015|E2|Reported Event|Placebo|Placebo : Topical; applied once daily for two weeks
225984|NCT01289015|E1|Reported Event|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
225985|NCT01288911|B3|Baseline|Total|Total of all reporting groups
225986|NCT01288911|B2|Baseline|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225987|NCT01288911|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225988|NCT01288911|P2|Participant Flow|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225989|NCT01288911|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225990|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225991|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225992|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225993|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225994|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225995|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225996|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225997|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225998|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
225999|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226000|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226001|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226002|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226003|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226004|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226005|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226006|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226007|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226008|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226009|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226010|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226011|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226012|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226013|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226014|NCT01288911|E2|Reported Event|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226015|NCT01288911|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
226016|NCT01288859|B1|Baseline|All Study Participants|All participants followed all the periods
226017|NCT01288859|P6|Participant Flow|Free Curcumin|Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)
226018|NCT01288859|P5|Participant Flow|Encapsulated Cocoa Polyphenols|Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.
226019|NCT01288859|P4|Participant Flow|Control Cream|Subjects consumed 3 nut cream portions (33g each).
226020|NCT01288859|P3|Participant Flow|Free Cocoa Polyphenol|Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.
226021|NCT01288859|P2|Participant Flow|Encapsulated Curcumin + PQG|Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.
226022|NCT01288859|P1|Participant Flow|Encapsulated Curcumin|Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)
226023|NCT01288859|O6|Outcome|Free Curcumin|Subjects consumed bread added with free curcumin
226024|NCT01288859|O5|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed nut creams added with encapsulate cocoa-polyphenols
226025|NCT01288859|O4|Outcome|Control|Subjects consumed white bread or nut cream
226026|NCT01288859|O3|Outcome|Free Cocoa Polyphenol|subjects consumed nut creams added with cocoa polyphenols
226027|NCT01288859|O2|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread containing encapsulated curcumin plus PQG (i.e. Piperine, Quercetin and Genistein)
226028|NCT01288859|O1|Outcome|Encapsulated Curcumin|subjects consumed bread containing encapsulated curcumin
226029|NCT01288859|O6|Outcome|Free Curcumin|Subjects consumed bread added with free curcumin
226030|NCT01288859|O5|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed nut creams added with encapsulate cocoa-polyphenols
226031|NCT01288859|O4|Outcome|Control|Subjects consumed white bread or nut cream
226032|NCT01288859|O3|Outcome|Free Cocoa Polyphenol|subjects consumed nut creams added with cocoa polyphenols
226033|NCT01288859|O2|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread containing encapsulated curcumin plus PQG (i.e. Piperine, Quercetin and Genistein)
226034|NCT01288859|O1|Outcome|Encapsulated Curcumin|subjects consumed bread containing encapsulated curcumin
226035|NCT01288859|O6|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed cocoa-nut cream enriched with encapsulated cocoa polyphenols
226036|NCT01288859|O5|Outcome|Free Cocoa Polyphenols|subjects consumed cocoa-nut cream enriched with cocoa polyphenols in the free form
226037|NCT01288859|O4|Outcome|Control Cream|subjects consumed cocoa-nut cream
226038|NCT01288859|O3|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread enriched with encapsulated curcumin plus piperine, quercetin and genistein
226039|NCT01288859|O2|Outcome|Encapsulated Curcumin|subjects consumed bread enriched with encapsulated curcumin
226040|NCT01288859|O1|Outcome|Free Curcumin|subjects consumed bread enriched with free curcumin
226041|NCT01288859|E6|Reported Event|Free Curcumin|Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)
226042|NCT01288859|E5|Reported Event|Encapsulated Cocoa Polyphenols|Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.
226043|NCT01288859|E4|Reported Event|Control Cream|Subjects consumed 3 nut cream portions (33g each).
226044|NCT01288859|E3|Reported Event|Free Cocoa Polyphenol|Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.
226045|NCT01288859|E2|Reported Event|Encapsulated Curcumin + PQG|Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.
226046|NCT01288859|E1|Reported Event|Encapsulated Curcumin|Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)
226047|NCT01288781|B3|Baseline|Total|Total of all reporting groups
226048|NCT01288781|B2|Baseline|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226049|NCT01288781|B1|Baseline|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226050|NCT01288781|P2|Participant Flow|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226051|NCT01288781|P1|Participant Flow|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226052|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226053|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226054|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226055|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226056|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226057|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226058|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226059|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226060|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226061|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226062|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226063|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226064|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226065|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226066|NCT01288781|E2|Reported Event|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226067|NCT01288781|E1|Reported Event|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
226068|NCT01288729|B3|Baseline|Total|Total of all reporting groups
226069|NCT01288729|B2|Baseline|Group 2 - Teflon Cathetar, the Steel|Participants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set.
226070|NCT01288729|B1|Baseline|Group 1 - Steel Cathetar, Then Teflon|Participants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set.
226071|NCT01288729|P2|Participant Flow|Group 2 - Teflon Cathetar, the Steel|Participants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set.
226072|NCT01288729|P1|Participant Flow|Group 1: Steel Cathetar, Then Teflon|Participants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set.
226073|NCT01288729|O2|Outcome|Quick-Set Teflon Catheter|"Participants will wear the Quick-Set Teflon catheter for 7 days (for a total of 14 days for the duration of the study).
Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
226074|NCT01288729|O1|Outcome|Sure-T Steel Infusion Set Catheter|"Participants will wear Sure-T Steel Infusion Set Catheter for 7 days (for a total of 14 days for the duration of the study)
Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
226075|NCT01288729|E2|Reported Event|Quick-Set Teflon Catheter|"Participants will wear the Quick-Set Teflon catheter for 7 days (for a total of 14 days for the duration of the study).
Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
226076|NCT01288729|E1|Reported Event|Sure-T Steel Infusion Set Catheter|"Participants will wear Sure-T Steel Infusion Set Catheter for 7 days (for a total of 14 days for the duration of the study)
Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
226077|NCT01288612|B4|Baseline|Total|Total of all reporting groups
226078|NCT01288612|B3|Baseline|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226079|NCT01288612|B2|Baseline|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226080|NCT01288612|B1|Baseline|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
226081|NCT01288612|P3|Participant Flow|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226082|NCT01288612|P2|Participant Flow|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226124|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226731|NCT01286558|E1|Reported Event|80 mg Telmisartan and 5 mg Amlodipine FDC|
226083|NCT01288612|P1|Participant Flow|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
226084|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226085|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226086|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
226087|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226088|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226089|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
226090|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226091|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226092|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
226093|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226094|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226095|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
226096|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226097|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226098|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
226099|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226100|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226125|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
228204|NCT01283516|E2|Reported Event|LDK378 100 mg|LDK378 100 mg
226101|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
226102|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226103|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226104|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
226105|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226106|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226107|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
226108|NCT01288612|E3|Reported Event|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226109|NCT01288612|E2|Reported Event|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
226110|NCT01288612|E1|Reported Event|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
226111|NCT01288534|B1|Baseline|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
226112|NCT01288534|P1|Participant Flow|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
226113|NCT01288534|O1|Outcome|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
226114|NCT01288534|E1|Reported Event|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
226115|NCT01288469|B4|Baseline|Total|Total of all reporting groups
226116|NCT01288469|B3|Baseline|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226117|NCT01288469|B2|Baseline|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
226118|NCT01288469|B1|Baseline|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226119|NCT01288469|P3|Participant Flow|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226120|NCT01288469|P2|Participant Flow|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
226121|NCT01288469|P1|Participant Flow|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226122|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226123|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
226169|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226126|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
226127|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226128|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226129|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
226130|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226131|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226132|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
226133|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226134|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226135|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
226136|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226137|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226138|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
226139|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226140|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226141|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
226142|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226143|NCT01288469|E3|Reported Event|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226144|NCT01288469|E2|Reported Event|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
226145|NCT01288469|E1|Reported Event|Placebo + Atorvastatin 80mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
226146|NCT01288443|B7|Baseline|Total|Total of all reporting groups
226147|NCT01288443|B6|Baseline|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226148|NCT01288443|B5|Baseline|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226149|NCT01288443|B4|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226150|NCT01288443|B3|Baseline|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226151|NCT01288443|B2|Baseline|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226152|NCT01288443|B1|Baseline|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226153|NCT01288443|P6|Participant Flow|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226154|NCT01288443|P5|Participant Flow|Alirocumab 200 mg Q4W|Alirocumab 200 mg every 4 weeks (Q4W) and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226155|NCT01288443|P4|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226156|NCT01288443|P3|Participant Flow|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226157|NCT01288443|P2|Participant Flow|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226158|NCT01288443|P1|Participant Flow|Placebo|Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
226159|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226160|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226161|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226162|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226163|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226164|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226165|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226166|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226167|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226168|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226903|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226170|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226171|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226172|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226173|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226174|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226175|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226176|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226177|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226178|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226179|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226180|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226181|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226182|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226183|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226184|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226185|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226186|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226187|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226188|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226189|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226190|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226191|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226192|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226193|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226194|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226195|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226196|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226197|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226198|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226199|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226200|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226201|NCT01288443|E6|Reported Event|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226202|NCT01288443|E5|Reported Event|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226203|NCT01288443|E4|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226204|NCT01288443|E3|Reported Event|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226205|NCT01288443|E2|Reported Event|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
226206|NCT01288443|E1|Reported Event|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
226207|NCT01288287|B1|Baseline|Safety Set (All Patients)|"Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.
Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol."
226208|NCT01288287|P1|Participant Flow|All Patients|Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.
226209|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
226210|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
226211|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
226479|NCT01287221|B2|Baseline|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
226212|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
226213|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
226214|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
226215|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
226216|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
226217|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
226218|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
226219|NCT01288287|E1|Reported Event|Safety Set (All Patients)|"Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.
Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol."
226220|NCT01288209|B3|Baseline|Total|Total of all reporting groups
226221|NCT01288209|B2|Baseline|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
226222|NCT01288209|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
226223|NCT01288209|P2|Participant Flow|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
226224|NCT01288209|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
226225|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226226|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226227|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226228|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226229|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226230|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226231|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226293|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
228205|NCT01283516|E1|Reported Event|LDK378 50 mg|LDK378 50 mg
226232|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226233|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226234|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226235|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226236|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226237|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226238|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226239|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226240|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226241|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226242|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226243|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226244|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226245|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226246|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
226247|NCT01288209|E2|Reported Event|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
226294|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
228206|NCT01283464|B3|Baseline|Total|Total of all reporting groups
226248|NCT01288209|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
226249|NCT01288079|B5|Baseline|Total|Total of all reporting groups
226250|NCT01288079|B4|Baseline|Placebo|
226251|NCT01288079|B3|Baseline|60 mg QD Duloxetine|
226252|NCT01288079|B2|Baseline|4 mg BID TC-5214|
226253|NCT01288079|B1|Baseline|1 mg BID TC-5214|
226254|NCT01288079|P4|Participant Flow|Placebo|
226255|NCT01288079|P3|Participant Flow|60 mg QD Duloxetine|
226256|NCT01288079|P2|Participant Flow|4 mg BID TC-5214|
226257|NCT01288079|P1|Participant Flow|1 mg BID TC-5214|
226258|NCT01288079|O4|Outcome|Placebo|
226259|NCT01288079|O3|Outcome|60 mg QD Duloxetine|
226260|NCT01288079|O2|Outcome|4 mg BID TC-5214|
226261|NCT01288079|O1|Outcome|1 mg BID TC-5214|
226262|NCT01288079|E4|Reported Event|Placebo|
226263|NCT01288079|E3|Reported Event|60 mg QD Duloxetine|
226264|NCT01288079|E2|Reported Event|4 mg BID TC-5214|
226265|NCT01288079|E1|Reported Event|1 mg BID TC-5214|
226266|NCT01288027|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
226267|NCT01288027|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
226268|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
226269|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
226270|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
226271|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
226272|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
226273|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
226274|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
226275|NCT01288027|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
226276|NCT01287897|B5|Baseline|Total|Total of all reporting groups
226277|NCT01287897|B4|Baseline|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226278|NCT01287897|B3|Baseline|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226279|NCT01287897|B2|Baseline|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226280|NCT01287897|B1|Baseline|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226281|NCT01287897|P4|Participant Flow|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226282|NCT01287897|P3|Participant Flow|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226283|NCT01287897|P2|Participant Flow|PF-04236921 10 Milligram (mg)|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226284|NCT01287897|P1|Participant Flow|Placebo|Placebo administered subcutaneously (SC) in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226285|NCT01287897|O4|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226286|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226287|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226288|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226289|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226290|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226291|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226292|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
227949|NCT01284426|P1|Participant Flow|Chronic Urticaria|Chronic urticaria, Natural history
226295|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226296|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226297|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226298|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226299|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226300|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226301|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226302|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226303|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226304|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226305|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226306|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226307|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226308|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226309|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226310|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226311|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226312|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226313|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226314|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226315|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226316|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226317|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226318|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226319|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226320|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226321|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226322|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226323|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226324|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226325|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
228207|NCT01283464|B2|Baseline|Tretinoin|Tretinoin 0.02% cream
226326|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226327|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226328|NCT01287897|E4|Reported Event|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226329|NCT01287897|E3|Reported Event|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226330|NCT01287897|E2|Reported Event|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226331|NCT01287897|E1|Reported Event|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
226332|NCT01287832|B3|Baseline|Total|Total of all reporting groups
226333|NCT01287832|B2|Baseline|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
226334|NCT01287832|B1|Baseline|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
226335|NCT01287832|P2|Participant Flow|High-dose Daptomycin|Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
226336|NCT01287832|P1|Participant Flow|High Dose Vancomycin|Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
226337|NCT01287832|O2|Outcome|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
226338|NCT01287832|O1|Outcome|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
226339|NCT01287832|E2|Reported Event|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
226340|NCT01287832|E1|Reported Event|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
226341|NCT01287754|B3|Baseline|Total|Total of all reporting groups
226342|NCT01287754|B2|Baseline|Untreated|Participants without the EGFR mutation were followed for overall survival but did not undergo treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
226343|NCT01287754|B1|Baseline|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
226344|NCT01287754|P2|Participant Flow|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
226345|NCT01287754|P1|Participant Flow|Erlotinib|Participants positive for the epidermal growth factor receptor (EGFR) mutation and who met eligibility criteria received treatment with erlotinib, 150 milligrams (mg) orally once daily until disease progression or unacceptable toxicity.
226346|NCT01287754|O1|Outcome|All Participants|All participants underwent EGFR mutation testing at Screening. Those positive for the EGFR mutation and who met eligibility criteria (n = 3) received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity. The remaining participants (n = 21) were followed for overall survival but did not receive treatment.
226347|NCT01287754|O2|Outcome|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
226348|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
226349|NCT01287754|O2|Outcome|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
226350|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
226351|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
226352|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
226353|NCT01287754|E1|Reported Event|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
226354|NCT01287741|B3|Baseline|Total|Total of all reporting groups
226355|NCT01287741|B2|Baseline|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226480|NCT01287221|B1|Baseline|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
227950|NCT01284426|O1|Outcome|Chronic Urticaria|Chronic urticaria, Natural history
226356|NCT01287741|B1|Baseline|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226357|NCT01287741|P2|Participant Flow|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226358|NCT01287741|P1|Participant Flow|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226359|NCT01287741|O1|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226360|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226361|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226362|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226363|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226364|NCT01287741|O1|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226365|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226366|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226367|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226368|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226369|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226370|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226371|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226372|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226481|NCT01287221|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
226373|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226374|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226375|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226376|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226377|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226378|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226379|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226380|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226381|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226382|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226383|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226384|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226385|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226386|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226387|NCT01287741|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226388|NCT01287741|O1|Outcome|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226389|NCT01287741|E2|Reported Event|Obinutuzumab+Chemotherapy|Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226482|NCT01287221|P1|Participant Flow|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
228208|NCT01283464|B1|Baseline|Retinol|Retinol 1.0% cream
226390|NCT01287741|E1|Reported Event|Rituximab+Chemotherapy|Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
226391|NCT01287611|B3|Baseline|Total|Total of all reporting groups
226392|NCT01287611|B2|Baseline|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
226393|NCT01287611|B1|Baseline|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
226394|NCT01287611|P2|Participant Flow|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
226395|NCT01287611|P1|Participant Flow|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
226396|NCT01287611|O2|Outcome|Continuously Locked Closure Technique|"Eighty four patients were allocated to the control group. Due to expanded Kerr incisions 3 patients in control group did not receive their allocated intervention. In addition, 16 patients in the control group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 65 study group.
Continuously locked closure technique: Uterine Kerr incision will be closed with continuously locked suturing"
226397|NCT01287611|O1|Outcome|Purse String Closure Technique|"Eighty four patients were allocated to the study group. Due to expanded Kerr incisions 4 patients in study group did not receive their allocated intervention. In addition, 29 patients in the study group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 51 study group.
Purse string closure technique: Uterine Kerr incision will be closed with purse string suture"
226398|NCT01287611|O2|Outcome|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
226399|NCT01287611|O1|Outcome|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
226400|NCT01287611|E2|Reported Event|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
226401|NCT01287611|E1|Reported Event|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
226402|NCT01287416|B3|Baseline|Total|Total of all reporting groups
226403|NCT01287416|B2|Baseline|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226404|NCT01287416|B1|Baseline|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226405|NCT01287416|P2|Participant Flow|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226406|NCT01287416|P1|Participant Flow|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226407|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226456|NCT01287364|B2|Baseline|Mometasone Followed by Ciclesonide HFA|mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered
226483|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
229879|NCT01276821|B3|Baseline|Total|Total of all reporting groups
226408|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226409|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226410|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226411|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226412|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226413|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226414|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226415|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226416|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226484|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
226417|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226418|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226419|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226420|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226421|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226422|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226423|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226424|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226425|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226457|NCT01287364|B1|Baseline|Ciclesonide HFA Followed by Mometasone|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered.
226426|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226427|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226428|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226429|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226430|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226431|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226432|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226433|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226434|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226477|NCT01287364|E1|Reported Event|Ciclesonide|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily pooled
226435|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226436|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226437|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226438|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226439|NCT01287416|E2|Reported Event|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
226440|NCT01287416|E1|Reported Event|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
226441|NCT01287403|B1|Baseline|Entire Study Population|Includes groups randomized to receive either esterase wholegrain wheat flour first or liquid wholegrain wheat flour first or liquid wholegrain barley flour first or refined wheat flour first or wholegrain wheat flour first or wholegrain barley flour first
226442|NCT01287403|P1|Participant Flow|Six Products (Flours) Assigned Randomly (Cross Over)|"In a crossover design, all subjects were administered the 6 following products in a randomized order:
Esterase wholegrain wheat flour: a cereal flour treated with esterases to release phenolics (positive control for phenolic acids).
Refined wheat flour: a treated cereal flour mixed with milk (negative control).
Liquid whole grain wheat flour: a treated cereal flour mixed with milk.
Liquid wholegrain barley flour: a treated cereal flour mixed with milk.
Wholegrain wheat flour: a treated cereal flour mixed with milk.
Wholegrain barley flour: a treated cereal flour mixed with milk."
226443|NCT01287403|O6|Outcome|Wholegrain Barley Flour|A treated cereal flour mixed with milk.
226444|NCT01287403|O5|Outcome|Wholegrain Wheat Flour|A treated cereal flour mixed with milk.
226445|NCT01287403|O4|Outcome|Liquid Wholegrain Barley Flour|A treated cereal flour mixed with milk.
226446|NCT01287403|O3|Outcome|Liquid Whole Grain Wheat Flour|A treated cereal flour mixed with milk.
226447|NCT01287403|O2|Outcome|Refined Wheat Flour|A treated cereal flour mixed with milk(negative control).
226448|NCT01287403|O1|Outcome|Esterase Whole Grain Wheat Flour|A cereal flour treated with esterase to release phenolics (positive control for phenolic acids).
226449|NCT01287403|E6|Reported Event|Wholegrain Barley Flour|A treated cereal flour mixed with milk.
226450|NCT01287403|E5|Reported Event|Wholegrain Wheat Flour|A treated cereal flour mixed with milk.
226451|NCT01287403|E4|Reported Event|Liquid Wholegrain Barley Flour|A treated cereal flour mixed with milk.
226452|NCT01287403|E3|Reported Event|Liquid Whole Grain Wheat Flour|A treated cereal flour mixed with milk.
226453|NCT01287403|E2|Reported Event|Esterase Wholegrain Wheat Flour|A cereal flour treated with esterases to release phenolics (positive control for phenolic acids)
226454|NCT01287403|E1|Reported Event|Refined Wheat Flour|A treated cereal flour mixed with milk (negative control).
226455|NCT01287364|B3|Baseline|Total|Total of all reporting groups
226458|NCT01287364|P2|Participant Flow|Mometasone Followed by Ciclesonide HFA|mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered
226459|NCT01287364|P1|Participant Flow|Ciclesonide HFA Followed by Mometasone|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered.
226460|NCT01287364|O2|Outcome|Treatment Outcomes|Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Treatment Outcomes Component reflects the perceived outcomes of drug treatment, including longer relief; symptom relief, if both were the same price; for feeling better about your appearance; for fewer problems with irritation to nose; faster relief; and how it makes your nose feel.
226461|NCT01287364|O1|Outcome|Treatment Process|Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Treatment Process Component reflects preference on items pertaining to the perceived drug treatment process, including ease of use; convenience; flexibility in daily activities; taste; use in public; smell; fewer problems with medication running out of the nose; fewer problems with medication dripping down throat; and number of sprays per dose.
226462|NCT01287364|O3|Outcome|High Minus Low Response Group|Between Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
226463|NCT01287364|O2|Outcome|High Response Group|Within Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
226464|NCT01287364|O1|Outcome|Low Response Group|Within Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
226465|NCT01287364|O3|Outcome|High Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85; n = 55), Medium Change (2.08 to 1.74; n = 56), or High Change (6.57 to 2.14; n = 55) groups..
226466|NCT01287364|O2|Outcome|Medium Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85; n = 55), Medium Change (2.08 to 1.74; n = 56), or High Change (6.57 to 2.14; n = 55) groups.
226467|NCT01287364|O1|Outcome|Low Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
226468|NCT01287364|O3|Outcome|High Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
226469|NCT01287364|O2|Outcome|Medium Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
226470|NCT01287364|O1|Outcome|Low Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
226471|NCT01287364|O3|Outcome|High Symptoms|Patients were assigned to baseline rTNSS categories of High Symptoms (9.33 - 12.00; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
226472|NCT01287364|O2|Outcome|Medium Symptoms|Patients were assigned to baseline rTNSS categories of Medium Symptoms (7.25 - 9.25; n = 61). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
226473|NCT01287364|O1|Outcome|Low Symptoms|Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 - 7.17; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
226474|NCT01287364|O2|Outcome|Average Cronbach's Alpha (Standardized) Coefficients|Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
226475|NCT01287364|O1|Outcome|Average Cronbach's Alpha (Raw) Coefficients|Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
226476|NCT01287364|E2|Reported Event|Mometasone|mometasone nasal inhalation 200 μg once daily pooled
226478|NCT01287221|B3|Baseline|Total|Total of all reporting groups
226485|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
226486|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
226487|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
226488|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
226489|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
226490|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
226491|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
226492|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
226493|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
226494|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
226495|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
226496|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
226497|NCT01287221|E2|Reported Event|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
226498|NCT01287221|E1|Reported Event|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
226499|NCT01287208|B3|Baseline|Total|Total of all reporting groups
226500|NCT01287208|B2|Baseline|Blinded|Activity monitor with no feedback
226501|NCT01287208|B1|Baseline|Unblinded|Activity monitor with visible and on-line feedback
226502|NCT01287208|P2|Participant Flow|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
226503|NCT01287208|P1|Participant Flow|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
226504|NCT01287208|O2|Outcome|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
226505|NCT01287208|O1|Outcome|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
226506|NCT01287208|E2|Reported Event|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
226507|NCT01287208|E1|Reported Event|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
226508|NCT01287195|B1|Baseline|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
226509|NCT01287195|P1|Participant Flow|Oral OKT3|Participants with ulcerative colitis received 1 milligram (mg) Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
226510|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
226511|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
226512|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
226513|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
226514|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
226515|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
226516|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
226517|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
226518|NCT01287195|E1|Reported Event|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
226519|NCT01287117|B5|Baseline|Total|Total of all reporting groups
226520|NCT01287117|B4|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226521|NCT01287117|B3|Baseline|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226522|NCT01287117|B2|Baseline|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226523|NCT01287117|B1|Baseline|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226524|NCT01287117|P4|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226525|NCT01287117|P3|Participant Flow|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226526|NCT01287117|P2|Participant Flow|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226527|NCT01287117|P1|Participant Flow|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226528|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226529|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226530|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226531|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226532|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226533|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226534|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226535|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226536|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226537|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226538|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226539|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226540|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226541|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226542|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226543|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226544|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226545|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226546|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226547|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226548|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226549|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226550|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226551|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226552|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226553|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226554|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226555|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226556|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226557|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226558|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226559|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226560|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226561|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226562|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226563|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226564|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226565|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226566|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226567|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226568|NCT01287117|E4|Reported Event|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
226569|NCT01287117|E3|Reported Event|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
226570|NCT01287117|E2|Reported Event|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
226571|NCT01287117|E1|Reported Event|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
226593|NCT01287065|E1|Reported Event|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226594|NCT01287039|B3|Baseline|Total|Total of all reporting groups
226595|NCT01287039|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226596|NCT01287039|B1|Baseline|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226572|NCT01287065|B1|Baseline|Placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM in 1 of 6 Seq|All participants received one of the following three treatments in one of three treatment periods from the Dry Powder Inhaler (DPI) for 14 days: placebo in the morning (AM) and evening (PM), Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM, and FF/VI inhalation powder 100/25 µg PM and placebo AM. Participants were randomized to receive treatment in one of the six following sequences (seq): (1) placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM; (2) placebo, FF/VI 100/25 µg PM, FF/VI 100/25 µg AM; (3) FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, placebo; (4) FF/VI 100/25 µg AM, placebo, FF/VI 100/25 µg PM; (5) FF/VI 100/25 µg PM, placebo, FF/VI 100/25 µg AM; (6) FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, placebo. Each 14 day treatment period was followed by a 14-21 day washout period.
226573|NCT01287065|P6|Participant Flow|Sequence 6: FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, Placebo|Participants received FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
226574|NCT01287065|P5|Participant Flow|Sequence 5: FF/VI 100/25 µg PM, Placebo, FF/VI 100/25 µg AM|Participants received FF/VI 100/25 µg PM, placebo, and FF/VI 100/25 µg AM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
226575|NCT01287065|P4|Participant Flow|Sequence 4: FF/VI 100/25 µg AM, Placebo, FF/VI 100/25 µg PM|Participants received FF/VI 100/25 µg AM, placebo, and FF/VI 100/25 µg PM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
226576|NCT01287065|P3|Participant Flow|Sequence 3: FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, Placebo|Participants received FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
226577|NCT01287065|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg PM, FF/VI 100/25 µg AM|Participants received placebo, FF/VI 100/25 µg PM, and FF/VI 100/25 µg AM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
226578|NCT01287065|P1|Participant Flow|Sequence 1: Placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM|Participants received placebo, Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) AM, and FF/VI 100/25 µg PM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
226579|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226580|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226581|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226582|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226583|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226584|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226585|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226586|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226587|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226588|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226589|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226590|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226591|NCT01287065|E3|Reported Event|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
226592|NCT01287065|E2|Reported Event|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
227951|NCT01284426|E1|Reported Event|Chronic Urticaria|Chronic urticaria, Natural history
226597|NCT01287039|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226598|NCT01287039|P1|Participant Flow|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226599|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226600|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226601|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226602|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226603|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226604|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226605|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226606|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226607|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226608|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226609|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226610|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226611|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226612|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226613|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226614|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226615|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226616|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226617|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226618|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226619|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226620|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226621|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226622|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226623|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226624|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226625|NCT01287039|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226626|NCT01287039|E1|Reported Event|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
226627|NCT01286818|B1|Baseline|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226628|NCT01286818|P1|Participant Flow|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226665|NCT01286753|P2|Participant Flow|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR).
226666|NCT01286753|P1|Participant Flow|Tyrosine Kinase Inhibitor (TKI) Naive|Vemurafenib 960 milligrams (mg) orally twice daily in participants naive to any prior systemic TKI therapy.
226667|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
226668|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
226629|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226630|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226631|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226632|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226633|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226634|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226635|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226669|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
226670|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
227152|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
226636|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226637|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226638|NCT01286818|E1|Reported Event|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.
Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
226639|NCT01286805|B3|Baseline|Total|Total of all reporting groups
226640|NCT01286805|B2|Baseline|Control Group|The control group received only a combined spinal-epidural.
226641|NCT01286805|B1|Baseline|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
226642|NCT01286805|P2|Participant Flow|Control Group|The control group received only a combined spinal-epidural.
226643|NCT01286805|P1|Participant Flow|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
226644|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
226645|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
226646|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
226647|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
226648|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
226649|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
226650|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
226651|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
226652|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
226653|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
226654|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
226655|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
226656|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
226657|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
226658|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
226659|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
226660|NCT01286805|E2|Reported Event|Control Group|The control group received only a combined spinal-epidural.
226661|NCT01286805|E1|Reported Event|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
226662|NCT01286753|B3|Baseline|Total|Total of all reporting groups
226663|NCT01286753|B2|Baseline|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
226664|NCT01286753|B1|Baseline|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
226730|NCT01286558|E2|Reported Event|40 mg Telmisartan and 5 mg Amlodipine FDC|
226671|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
226672|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
226673|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
226674|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
226675|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
226676|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
226677|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
226678|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
226679|NCT01286753|O1|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
226680|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
226681|NCT01286753|E2|Reported Event|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
226682|NCT01286753|E1|Reported Event|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
226683|NCT01286740|B1|Baseline|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226684|NCT01286740|P1|Participant Flow|FTC/RPV/TDF|Participants switched from their existing treatment regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (tenofovir DF; TDF) to the FTC 200 mg/rilpivirine (RPV) 25 mg/TDF 300 mg single-table regimen (STR).
226685|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226686|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226687|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226688|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226689|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226690|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226691|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226692|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226693|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226694|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226695|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226696|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226697|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226698|NCT01286740|E1|Reported Event|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
226699|NCT01286558|B3|Baseline|Total|Total of all reporting groups
226700|NCT01286558|B2|Baseline|40 mg Telmisartan and 5 mg Amlodipine FDC|
226701|NCT01286558|B1|Baseline|80 mg Telmisartan and 5 mg Amlodipine FDC|
226702|NCT01286558|P2|Participant Flow|40 mg Telmisartan and 5 mg Amlodipine FDC|
226703|NCT01286558|P1|Participant Flow|80 mg Telmisartan and 5 mg Amlodipine FDC|
226704|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226705|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226706|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226707|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226708|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226709|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226710|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226711|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226712|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226713|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226714|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226715|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226716|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226717|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226718|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226719|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226720|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226721|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226722|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226723|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226724|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226725|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226726|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226727|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226728|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
226729|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
226732|NCT01286493|B1|Baseline|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3
rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
226733|NCT01286493|P1|Participant Flow|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3
rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
226734|NCT01286493|O1|Outcome|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3
rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
226735|NCT01286493|E1|Reported Event|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3
rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
226736|NCT01286480|B3|Baseline|Total|Total of all reporting groups
226737|NCT01286480|B2|Baseline|Usual Care|Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.
226738|NCT01286480|B1|Baseline|Clinic-based Educational Intervention|Clinic-based Educational Intervention: This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
226739|NCT01286480|P2|Participant Flow|Usual Care|Participants allocated to the usual care group were unaware of the intervention being offered to the treatment group. This was intended to prevent contamination by self-education or other means.
226740|NCT01286480|P1|Participant Flow|Intervention Arm|The intervention was conducted by one of three experienced cardiology nurses following intervention-facilitation training and fidelity assurance. The intervention involved a meeting with the nurse and the participant, with the exception of three interventions also attended by a father (n=1), an uncle (n=1) and a participant’s friend (n=1). Interventions were held in a quiet room without other distractions, a short walk from the cardiology clinic. The order of the intervention was consistently followed, and the study nurse completed a log and field notes to document any difficulties that were encountered during the intervention and the participant’s reaction, level of engagement, questions and body language. Interventions were offered on the same day as a routine clinic visit, or at a later date, depending on the participant’s preference.
226741|NCT01286480|O2|Outcome|Usual Care|Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.
226742|NCT01286480|O1|Outcome|Intervention|This involves a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport is created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists are also reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) are presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
226743|NCT01286480|O2|Outcome|Usual Care|Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.
226744|NCT01286480|O1|Outcome|Intervention|This involves a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport is created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists are also reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) are presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
226745|NCT01286480|E2|Reported Event|Usual Care|The youth in the usual care arm see a nurse for vitals. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.
226757|NCT01286454|P2|Participant Flow|Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in forth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
227153|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
226746|NCT01286480|E1|Reported Event|Intervention|This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
226747|NCT01286454|B1|Baseline|Entire Study Population|Includes groups randomized to receive fesoterodine 4 mg IR-BIC fasted first, 10% ER-BIC fasted first, 15% ER-BIC fasted first, 20% ER-BIC fasted first and ER tablets fasted first.
226748|NCT01286454|P11|Participant Flow|Fesoterodine 4 mg 10% ER Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in sixth intervention period. A washout period of approximately 2 weeks was maintained between fifth and sixth intervention period.
226749|NCT01286454|P10|Participant Flow|Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER|Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
226750|NCT01286454|P9|Participant Flow|Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
226751|NCT01286454|P8|Participant Flow|Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
226752|NCT01286454|P7|Participant Flow|Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
226753|NCT01286454|P6|Participant Flow|Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
226754|NCT01286454|P5|Participant Flow|Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER|Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
226755|NCT01286454|P4|Participant Flow|Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
226756|NCT01286454|P3|Participant Flow|Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
226792|NCT01286454|E3|Reported Event|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226793|NCT01286454|E2|Reported Event|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226758|NCT01286454|P1|Participant Flow|Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER|Single oral dose of fesoterodine 4 milligram (mg) immediate release (IR) beads-in-capsule (BIC) under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated extended release (ER) BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
226759|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
226760|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
226761|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226762|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226763|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226764|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
226765|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
226766|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
226767|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226768|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226769|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226770|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
226771|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
226772|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
226773|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226774|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226775|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226776|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
226777|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
226778|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
226779|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226780|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226781|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226782|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
226783|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
226784|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
226785|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226786|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226787|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226788|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
226789|NCT01286454|E6|Reported Event|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
226790|NCT01286454|E5|Reported Event|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
226791|NCT01286454|E4|Reported Event|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
226794|NCT01286454|E1|Reported Event|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
226795|NCT01286402|B3|Baseline|Total|Total of all reporting groups
226796|NCT01286402|B2|Baseline|Placebo|"Group receiving placebo
-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
226797|NCT01286402|B1|Baseline|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication
Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days
- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
226798|NCT01286402|P2|Participant Flow|Placebo|"Group receiving placebo
-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
226799|NCT01286402|P1|Participant Flow|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication
Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days
- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment"
226800|NCT01286402|O2|Outcome|Placebo|"Group receiving placebo
-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
226801|NCT01286402|O1|Outcome|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication
Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days
- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
226802|NCT01286402|E2|Reported Event|Placebo|"Group receiving placebo
-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
226803|NCT01286402|E1|Reported Event|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication
Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days
- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment"
226804|NCT01286324|B3|Baseline|Total|Total of all reporting groups
226805|NCT01286324|B2|Baseline|Placebo Tablet|Contained lactose
226806|NCT01286324|B1|Baseline|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
226807|NCT01286324|P2|Participant Flow|Placebo Tablet|Contained lactose
226808|NCT01286324|P1|Participant Flow|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
226809|NCT01286324|O2|Outcome|Placebo Tablet|Contained lactose
226810|NCT01286324|O1|Outcome|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
226811|NCT01286324|E2|Reported Event|Placebo Tablet|Contained lactose
226812|NCT01286324|E1|Reported Event|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
226813|NCT01286311|B3|Baseline|Total|Total of all reporting groups
226814|NCT01286311|B2|Baseline|Control|
226815|NCT01286311|B1|Baseline|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
226816|NCT01286311|P2|Participant Flow|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care. After 9 months, control group physicians were provided with lists of their eligible patients and their risk scores.
226817|NCT01286311|P1|Participant Flow|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
226818|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
226819|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
226820|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
226821|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
226822|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
226823|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
226824|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
226825|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
226826|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
226827|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
226828|NCT01286311|E2|Reported Event|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
226829|NCT01286311|E1|Reported Event|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
226830|NCT01286207|B4|Baseline|Total|Total of all reporting groups
226831|NCT01286207|B3|Baseline|Standard Care|Standard care at onset of migraine attack
226832|NCT01286207|B2|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226833|NCT01286207|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226834|NCT01286207|P3|Participant Flow|Standard Care|Standard care at onset of migraine attack
226835|NCT01286207|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226836|NCT01286207|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226837|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
226838|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226839|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226840|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
226841|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226842|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226843|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
226844|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226845|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226846|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
226847|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226848|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226849|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
226850|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226851|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226852|NCT01286207|E3|Reported Event|Standard Care|Standard care at onset of migraine attack
226853|NCT01286207|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226854|NCT01286207|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
226855|NCT01286168|B1|Baseline|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
226856|NCT01286168|P1|Participant Flow|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
226857|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
226858|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
226859|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
226860|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
226861|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
226862|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
226863|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
226864|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
226865|NCT01286168|E2|Reported Event|Control Side|"Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.
Control: Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care."
226866|NCT01286168|E1|Reported Event|Antisepsis Side|"A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.
Sodium hypochlorite (Dakin's Solution): 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day
Chlorhexidine gluconate disk: Apply one chlorhexidine disk to the intervention drain site(s) and change every three days
Occlusive Adhesive Dressing: A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days."
226867|NCT01286129|B3|Baseline|Total|Total of all reporting groups
226868|NCT01286129|B2|Baseline|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
226869|NCT01286129|B1|Baseline|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
226870|NCT01286129|P2|Participant Flow|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
226871|NCT01286129|P1|Participant Flow|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
226872|NCT01286129|O2|Outcome|Allergic Non Asthmatic|Change in nasal lavage eosinophil percentages in allergic non asthmatic at baseline and at 7h post first and last challenge
226873|NCT01286129|O1|Outcome|Allergic Asthmatic|Change in nasal lavage eosinophil percentages in allergic asthmatic at baseline and at 7h post first and last challenge
226874|NCT01286129|O2|Outcome|Allergic Rhinitic Without Asthma|Variation in sputum eosinophil percentage in allergic non asthmatic between baseline value and at 7h following first and last challenge
226875|NCT01286129|O1|Outcome|Allergic Asthmatic|Variation in sputum eosinophil percentage in allergic asthmatic between baseline value and at 7h following first and last challenge
226876|NCT01286129|E2|Reported Event|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
226877|NCT01286129|E1|Reported Event|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
226878|NCT01286077|B3|Baseline|Total|Total of all reporting groups
226879|NCT01286077|B2|Baseline|Non-treated Control|no treatment, observation only
226880|NCT01286077|B1|Baseline|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226881|NCT01286077|P2|Participant Flow|Non-treated Control|no treatment, observation only
226882|NCT01286077|P1|Participant Flow|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226883|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226884|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226885|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226886|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226887|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226888|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226889|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226890|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226891|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226892|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226893|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226894|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226895|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226896|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226897|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226898|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226899|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226900|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226901|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226902|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226904|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226905|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226906|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226907|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226908|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226909|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226910|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226911|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
226912|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226913|NCT01286077|E2|Reported Event|Non-treated Control|no treatment, observation only
226914|NCT01286077|E1|Reported Event|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
226915|NCT01286012|B3|Baseline|Total|Total of all reporting groups
226916|NCT01286012|B2|Baseline|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)
Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
226917|NCT01286012|B1|Baseline|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
226918|NCT01286012|P2|Participant Flow|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)
Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
226919|NCT01286012|P1|Participant Flow|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
226920|NCT01286012|O2|Outcome|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)
Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
226921|NCT01286012|O1|Outcome|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
226922|NCT01286012|O2|Outcome|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)
Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
226923|NCT01286012|O1|Outcome|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
226924|NCT01286012|E2|Reported Event|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)
Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
226925|NCT01286012|E1|Reported Event|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
226926|NCT01285947|B3|Baseline|Total|Total of all reporting groups
226927|NCT01285947|B2|Baseline|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
226928|NCT01285947|B1|Baseline|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
226929|NCT01285947|P2|Participant Flow|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
226930|NCT01285947|P1|Participant Flow|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
226931|NCT01285947|O2|Outcome|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
226932|NCT01285947|O1|Outcome|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
226933|NCT01285947|E2|Reported Event|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
226934|NCT01285947|E1|Reported Event|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
226935|NCT01285908|B1|Baseline|All Study Participants|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or Pure Autonomic Failure.
226936|NCT01285908|P3|Participant Flow|Norepinephrine, Then Saline|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of norepinephrine followed by IV administration of saline. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
226937|NCT01285908|P2|Participant Flow|Saline, Then Norepinephrine|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of saline followed by IV administration of norepinephrine. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
227051|NCT01285518|P8|Participant Flow|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
226938|NCT01285908|P1|Participant Flow|Baseline|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees). Baseline measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
226939|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of dihydroxyphenylglycol taken at varying tilt angles following a norepinephrine infusion.
226940|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of dihydroxyphenylglycol taken at varying tilt angles following a saline infusion.
226941|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of plasma levels of dihydroxyphenylglycol at varying tilt angles.
226942|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of norepinephrine taken at varying tilt angles following a norepinephrine infusion.
226943|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of norepinephrine taken at varying tilt angles following a saline infusion.
226944|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of plasma levels of norepinephrine at varying tilt angles.
226945|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of total peripheral resistance taken at varying tilt angles following a norepinephrine infusion.
226946|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of total peripheral resistance taken at varying tilt angles following a saline infusion.
226947|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of total peripheral resistance taken at varying tilt angles.
226948|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac output taken at varying tilt angles following a norepinephrine infusion.
226949|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac output taken at varying tilt angles following a saline infusion.
226950|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of cardiac output taken at varying tilt angles.
226951|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of average blood pressure taken at varying tilt angles following a norepinephrine infusion.
226952|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of average blood pressure taken at varying tilt angles following a saline infusion.
226953|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of average blood pressure taken at varying tilt angles.
226954|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac stroke volume taken at varying tilt angles following a norepinephrine infusion.
226955|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac stroke volume taken at varying tilt angles following a saline infusion.
226956|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of cardiac stroke volume taken at varying tilt angles.
226957|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of heart rate taken at varying tilt angles following a norepinephrine infusion.
226958|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of heart rate taken at varying tilt angles following a saline infusion.
226959|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of heart rate taken at varying tilt angles.
226960|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
226961|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
226962|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of diastolic blood pressure taken at varying tilt angles.
226963|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
227052|NCT01285518|P7|Participant Flow|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
226964|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
226965|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
226966|NCT01285908|E3|Reported Event|Norepinephrine, Then Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of norepinephrine, followed by IV administration of saline.
226967|NCT01285908|E2|Reported Event|Saline, Then Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of saline, followed by IV administration of norepinephrine.
226968|NCT01285908|E1|Reported Event|Baseline|The participants are patients with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of BP at varying tilt angles.
226969|NCT01285843|B3|Baseline|Total|Total of all reporting groups
226970|NCT01285843|B2|Baseline|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
226971|NCT01285843|B1|Baseline|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
226972|NCT01285843|P2|Participant Flow|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
226973|NCT01285843|P1|Participant Flow|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
226974|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
226975|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
226976|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
226977|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
226978|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
226979|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
226980|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
226981|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
226982|NCT01285843|E2|Reported Event|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
226983|NCT01285843|E1|Reported Event|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
226984|NCT01285791|B4|Baseline|Total|Total of all reporting groups
226985|NCT01285791|B3|Baseline|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
226986|NCT01285791|B2|Baseline|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
226987|NCT01285791|B1|Baseline|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
226988|NCT01285791|P3|Participant Flow|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
226989|NCT01285791|P2|Participant Flow|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
226990|NCT01285791|P1|Participant Flow|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
226991|NCT01285791|O3|Outcome|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
226992|NCT01285791|O2|Outcome|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
226993|NCT01285791|O1|Outcome|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
226994|NCT01285791|E3|Reported Event|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
226995|NCT01285791|E2|Reported Event|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
227053|NCT01285518|P6|Participant Flow|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
226996|NCT01285791|E1|Reported Event|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
226997|NCT01285713|B3|Baseline|Total|Total of all reporting groups
226998|NCT01285713|B2|Baseline|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
226999|NCT01285713|B1|Baseline|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
227000|NCT01285713|P2|Participant Flow|Normal Saline (NS)|10cc/kg NS, followed by 30cc/kg NS
227001|NCT01285713|P1|Participant Flow|5% Dextrose (D5) in Normal Saline (NS)|10cc/kg D5NS, followed by 30cc/kg NS
227002|NCT01285713|O2|Outcome|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
227003|NCT01285713|O1|Outcome|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
227004|NCT01285713|E2|Reported Event|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
227005|NCT01285713|E1|Reported Event|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
227006|NCT01285635|B4|Baseline|Total|Total of all reporting groups
227007|NCT01285635|B3|Baseline|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227008|NCT01285635|B2|Baseline|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
227009|NCT01285635|B1|Baseline|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227010|NCT01285635|P3|Participant Flow|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227011|NCT01285635|P2|Participant Flow|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227012|NCT01285635|P1|Participant Flow|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227013|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227014|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227015|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227016|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227017|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227018|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227019|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227020|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
227021|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227022|NCT01285635|O1|Outcome|Docetaxel and AT-101|"Patients all receive Docetaxel 75mg/m^2 on Day 1. Patients will receive AT-101 on one of the following arms:
Arm A: Docetaxel alone for two weeks, then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
Arm B: AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
Arm C: AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles."
227023|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227024|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227025|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227026|NCT01285635|E3|Reported Event|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227027|NCT01285635|E2|Reported Event|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227028|NCT01285635|E1|Reported Event|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
227029|NCT01285609|B3|Baseline|Total|Total of all reporting groups
227030|NCT01285609|B2|Baseline|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227031|NCT01285609|B1|Baseline|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227054|NCT01285518|P5|Participant Flow|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227032|NCT01285609|P2|Participant Flow|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemotherapy Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227033|NCT01285609|P1|Participant Flow|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227034|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227035|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227036|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227037|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227038|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227039|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227040|NCT01285609|E2|Reported Event|Placebo With Paclitaxel/Carboplatin|Placebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227041|NCT01285609|E1|Reported Event|Ipilimumab With Paclitaxel/Carboplatin|Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
227042|NCT01285518|B9|Baseline|Total|Total of all reporting groups
227043|NCT01285518|B8|Baseline|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227044|NCT01285518|B7|Baseline|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227045|NCT01285518|B6|Baseline|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227046|NCT01285518|B5|Baseline|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227047|NCT01285518|B4|Baseline|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227048|NCT01285518|B3|Baseline|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227049|NCT01285518|B2|Baseline|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227050|NCT01285518|B1|Baseline|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227055|NCT01285518|P4|Participant Flow|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227056|NCT01285518|P3|Participant Flow|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227057|NCT01285518|P2|Participant Flow|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227058|NCT01285518|P1|Participant Flow|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227059|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227060|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227061|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227062|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227063|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227064|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227065|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227066|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227067|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227068|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227069|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227070|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227071|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227072|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227073|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227074|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227075|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227076|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227077|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227078|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227079|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227080|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227081|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227082|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227083|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227084|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227085|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227086|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227087|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227088|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227089|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227090|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227091|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227092|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227093|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227094|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227095|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227096|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227097|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227098|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227099|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227100|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227101|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227102|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227103|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
233618|NCT01264770|P4|Participant Flow|ADALIMUMAB 40 MG SC|Dosing Group D
227104|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227105|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227106|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227107|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227108|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227109|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227110|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227111|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227112|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227113|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227114|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227115|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227116|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227117|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227118|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227119|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227120|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227121|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227122|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227123|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227124|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227125|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227126|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227127|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227128|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227129|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227130|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227131|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227132|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227133|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227134|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227135|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227136|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227137|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227138|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227139|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227140|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227141|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227142|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227143|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227144|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227145|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227146|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227147|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227148|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227149|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227150|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227151|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
239261|NCT01251315|O1|Outcome|Placebo-A|Placebo low dose group
227154|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227155|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227156|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227157|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227158|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227159|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227160|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227161|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227162|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227163|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227164|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227165|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227166|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227167|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227168|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227169|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227170|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227171|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227172|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227173|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227174|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227175|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227176|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227177|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227178|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227179|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227180|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227181|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227182|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227183|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227184|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227185|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227186|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227187|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227188|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227189|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227190|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227191|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227192|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227193|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227194|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227195|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227196|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227197|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227198|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227199|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227200|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227201|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
239612|NCT01250418|B3|Baseline|Total|Total of all reporting groups
227202|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227203|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227204|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227205|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227206|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227207|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227208|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227209|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227210|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227211|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227212|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227213|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227214|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227215|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227216|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227217|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227218|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227219|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227220|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227221|NCT01285518|O1|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227222|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227223|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227224|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227225|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227226|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227227|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227228|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227229|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227230|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227231|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227232|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227233|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227234|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227235|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227236|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227237|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227238|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227239|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227240|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227241|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227242|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227243|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227244|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227245|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227246|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227247|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227248|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227249|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227250|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227251|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227252|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227253|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227254|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227255|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227256|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227257|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227258|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227259|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227260|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227261|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227262|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227263|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227264|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227265|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227266|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227267|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227268|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227269|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227270|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227271|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227272|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227273|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227274|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227275|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227276|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227277|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227278|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227279|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227280|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227281|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227282|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227283|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227284|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227285|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227286|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227287|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227288|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227289|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227290|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227291|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227292|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227293|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227294|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227295|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227296|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227297|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227298|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
241954|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
227299|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227300|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227301|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227302|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227303|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227304|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227305|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227306|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227307|NCT01285518|E8|Reported Event|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
227308|NCT01285518|E7|Reported Event|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
227309|NCT01285518|E6|Reported Event|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
227310|NCT01285518|E5|Reported Event|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
227311|NCT01285518|E4|Reported Event|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
227312|NCT01285518|E3|Reported Event|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
227313|NCT01285518|E2|Reported Event|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
227314|NCT01285518|E1|Reported Event|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
227315|NCT01285492|B3|Baseline|Total|Total of all reporting groups
227316|NCT01285492|B2|Baseline|Tiotropium|tiotropium 18 μg o.d.
227317|NCT01285492|B1|Baseline|QVA149|QVA149 110/50 μg once a day (o.d)
227318|NCT01285492|P2|Participant Flow|Tiotropium|tiotropium 18 μg o.d.
227319|NCT01285492|P1|Participant Flow|QVA149|QVA149 110/50 μg o.d. (once a day)
227320|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
227321|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
227322|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
227323|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
227324|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
227325|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
227326|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
227327|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
227328|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
227329|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
227330|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
227331|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
227332|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
227333|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
227334|NCT01285492|E2|Reported Event|Tiotropium|tiotropium 18 μg o.d.
227335|NCT01285492|E1|Reported Event|QVA149|QVA149 110/50 μg once a day (o.d)
227336|NCT01285427|B1|Baseline|DNA Loci (SeCore vs. SSP UniTray Platforms)|
227337|NCT01285427|P1|Participant Flow|DNA Loci (SeCore vs. SSP UniTray Platforms)|
227338|NCT01285427|O1|Outcome|SeCore® Kit, DR Group Kit (DRB345 Loci)|SeCore® Kit, DR Group Kit (DRB345 Loci),
227339|NCT01285427|O1|Outcome|SeCore® Kit, DR Group Kit (DRB1 Locus)|SeCore® Kit, DR Group Kit (DRB1 Locus),
227340|NCT01285427|O1|Outcome|SeCore® Kit, DRB1 Locus|SeCore® Kit, DRB1 Locus
227341|NCT01285427|O1|Outcome|SeCore® Kit, DQB1 Locus|SeCore® Kit, DQB1 Locus
227342|NCT01285427|O1|Outcome|SeCore® DPB1 Locus Kit|SeCore® DPB1 Locus Kit
227343|NCT01285427|O1|Outcome|SeCore® Kit, C Locus|SeCore® Kit, C Locus
227344|NCT01285427|O1|Outcome|SeCore® Kit, B Locus (Single Amp)|SeCore® Kit, B Locus (Single Amp)
227345|NCT01285427|O1|Outcome|Concordance|SeCore kit, A Locus
227346|NCT01285427|O1|Outcome|Concordance|All SeCore Kits
227347|NCT01285427|E1|Reported Event|Concordance|All SeCore Kits
227348|NCT01285401|B3|Baseline|Total|Total of all reporting groups
227349|NCT01285401|B2|Baseline|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227350|NCT01285401|B1|Baseline|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227351|NCT01285401|P2|Participant Flow|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227352|NCT01285401|P1|Participant Flow|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25-hydroxyvitamin D [25(OH)D3] serum levels below 150 nano mol per liter (nmol/L) received Vigantol oil 6,670 international unit per day (IU/d) [167 microgram per day (mcg/d)] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous three times a week (tiw).
227353|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227354|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
228194|NCT01283516|O3|Outcome|LDK378 200 mg|Participants receiving 200 mg of LDK378
227355|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227356|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227357|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227358|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227359|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227360|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227361|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227362|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227363|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227364|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227365|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227366|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227367|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227368|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227369|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227370|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227371|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227372|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227373|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227374|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227375|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227376|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227377|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227378|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227379|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227380|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227381|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227382|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227484|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227383|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227384|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227385|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227386|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227387|NCT01285401|E2|Reported Event|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
227388|NCT01285401|E1|Reported Event|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
227389|NCT01285323|B3|Baseline|Total|Total of all reporting groups
227390|NCT01285323|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227391|NCT01285323|B1|Baseline|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227392|NCT01285323|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227393|NCT01285323|P1|Participant Flow|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227394|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227395|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227396|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227397|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227398|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227399|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227400|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227401|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227402|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227403|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227404|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227405|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227406|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227407|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227408|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227409|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227410|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227411|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227412|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227413|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227414|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227415|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227416|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227417|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227418|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227419|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227420|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227421|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227422|NCT01285323|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227423|NCT01285323|E1|Reported Event|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
227424|NCT01285310|B4|Baseline|Total|Total of all reporting groups
227425|NCT01285310|B3|Baseline|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase and continued 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
228195|NCT01283516|O2|Outcome|LDK378 100 mg|Participants receiving 100 mg of LDK378
227426|NCT01285310|B2|Baseline|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase and continued 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227427|NCT01285310|B1|Baseline|Placebo|Placebo: Oral Placebo tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in active treatment / active treatment extension phase. Participants who are nonresponders were transitioned early to 20 mg Apremilast BID at Week 16.
227428|NCT01285310|P5|Participant Flow|Placebo / Apremilast 20 mg XO|"Participants initially randomized to receive placebo twice daily who were transitioned at Week 24 (XO) to receive 20 mg apremilast for up to Week 52.
At week 52, they were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
227429|NCT01285310|P4|Participant Flow|Placebo/Apremilast 20mg EE|"Participants initially randomized to receive placebo twice daily and were transitioned due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to week 24.
At week 24, participants were continued on Apremilast 20 mg BID for up to Week 52.
At week 52, they were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
227430|NCT01285310|P3|Participant Flow|Apremilast 30 mg|"Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 52 in the active treatment.
At week 52, participants were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
227431|NCT01285310|P2|Participant Flow|Apremilast 20 mg|"Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily (BID) for up to Week 52 in the active treatment.
At week 52, participants were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
227432|NCT01285310|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg Apremilast twice daily (early escape), and were designated as Placebo/Apremilast 20mg EE.
227433|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227434|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227435|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227436|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227437|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227438|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227439|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227440|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227441|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227442|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227443|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227444|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227445|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227446|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227447|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227448|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227449|NCT01285310|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227450|NCT01285310|O1|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227451|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227452|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227453|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227454|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227455|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227456|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227457|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227458|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
227459|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227460|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227461|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227462|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227463|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227464|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227465|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227466|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227467|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227468|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227469|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227470|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227471|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227472|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227473|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|.Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227474|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227475|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227476|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227477|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily
227478|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227479|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227480|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227481|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227482|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227483|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
228196|NCT01283516|O1|Outcome|LDK378 50 mg|Participants receiving 50 mg of LDK378
227485|NCT01285310|O2|Outcome|Placebo / Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227486|NCT01285310|O1|Outcome|Placebo/Apremilast 20 EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227487|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227488|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227489|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227490|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227491|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227492|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227493|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227494|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227495|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227496|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227497|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227498|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227499|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227500|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227501|NCT01285310|O2|Outcome|Placebo / Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227502|NCT01285310|O1|Outcome|Placebo/Apremilast 20 EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227503|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227504|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227505|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227506|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227507|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227508|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227509|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227510|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227511|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227512|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227513|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227514|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227515|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227516|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227517|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227518|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227519|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227520|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227521|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227522|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227523|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227524|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227525|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227526|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227527|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227528|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227529|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227530|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227531|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227532|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227533|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned transitioned to receive 20 mg apremilast twice daily.
227534|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227535|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227536|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227537|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
227538|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
227539|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227540|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227541|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned to 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227542|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
227543|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
227544|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227545|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227546|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227547|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227548|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227549|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227550|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned to 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227551|NCT01285310|O3|Outcome|Apremilast 30 mg|.Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227552|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227553|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227554|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227555|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227556|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227557|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227558|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227559|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape)and were designated as Placebo/Apremilast 20mg EE.
227560|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
227561|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227562|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227563|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
227564|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227603|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227604|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227565|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227566|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227567|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227568|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227569|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
227570|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
227571|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227572|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
227573|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
227574|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227575|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
227576|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
227577|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE .
227578|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227579|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227580|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227581|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
227582|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
227583|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227584|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227585|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227586|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE ..
227587|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
227588|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
227589|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227590|NCT01285310|O3|Outcome|Apremilast 30 mg|.Participants initially randomized to receive 30 mg apremilast tablets twice daily
227591|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
227592|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227593|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
227594|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily
227595|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape).
227596|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
227597|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227598|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227599|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227600|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227601|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227602|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
227605|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227606|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227607|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227608|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227609|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227610|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily
227611|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
227612|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227613|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227614|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227615|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227616|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227617|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
227618|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227619|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227620|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227621|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227622|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227623|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227624|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227625|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227626|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227627|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227628|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227629|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
227630|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227631|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227632|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227633|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227634|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227635|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
227636|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227637|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227638|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227639|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227640|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227641|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227642|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227643|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227644|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227645|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227646|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227647|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227648|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227649|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE
227650|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
227651|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
227652|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
227653|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227654|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227655|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227656|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
227657|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
227658|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
227659|NCT01285310|E5|Reported Event|Study Termination: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Study Termination.
227660|NCT01285310|E4|Reported Event|Study Termination: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Study Termination.
227661|NCT01285310|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
227662|NCT01285310|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
227663|NCT01285310|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
227664|NCT01285076|B1|Baseline|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227665|NCT01285076|P1|Participant Flow|All Enrolled Participants|Adults with Type 2 diabetes mellitus (DM) ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227666|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227667|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227668|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227669|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227670|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227671|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227672|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227673|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227674|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227675|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227676|NCT01285076|E1|Reported Event|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
227677|NCT01285050|B1|Baseline|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy
Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.
raltegravir: HIV medication, 400 mg twice daily by mouth
Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
227678|NCT01285050|P1|Participant Flow|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy
Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.
raltegravir: HIV medication, 400 mg twice daily by mouth
Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
227679|NCT01285050|O2|Outcome|Post ART HCV Decline|HCV RNA determined by RT-PCR and expressed as log IU/ml after ART
227680|NCT01285050|O1|Outcome|Pre ART HCV RNA Decline|"HCV viral load determined by RT-PCR and reported as log IU/ml before giving antiretroviral therapy (ART)
Interferon alfa-2b was administered once as part of a pharmacokinetic study before and after ART.
ART included:
raltegravir: HIV medication, 400 mg twice daily by mouth
Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
227681|NCT01285050|E1|Reported Event|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy
Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.
raltegravir: HIV medication, 400 mg twice daily by mouth
Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
227682|NCT01285024|B3|Baseline|Total|Total of all reporting groups
227683|NCT01285024|B2|Baseline|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty
Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
227684|NCT01285024|B1|Baseline|Control|No Vitagel used during total hip arthroplasty
227952|NCT01284361|B1|Baseline|Control and Test Crossover|test and control intermittent urinary catheters : randomized cross-over
227685|NCT01285024|P2|Participant Flow|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty
Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
227686|NCT01285024|P1|Participant Flow|Control|No Vitagel used during total hip arthroplasty
227687|NCT01285024|O2|Outcome|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty
Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
227688|NCT01285024|O1|Outcome|Control|No Vitagel used during total hip arthroplasty
227689|NCT01285024|O2|Outcome|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty
Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
227690|NCT01285024|O1|Outcome|Control|No Vitagel used during total hip arthroplasty
227691|NCT01285024|E2|Reported Event|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty
Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
227692|NCT01285024|E1|Reported Event|Control|No Vitagel used during total hip arthroplasty
227693|NCT01284959|B4|Baseline|Total|Total of all reporting groups
227694|NCT01284959|B3|Baseline|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
227695|NCT01284959|B2|Baseline|Placebo|drug: lactose group: placebo
227696|NCT01284959|B1|Baseline|Risperidone|Drug: risperidone Groups: risperidone
227697|NCT01284959|P3|Participant Flow|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
227698|NCT01284959|P2|Participant Flow|Placebo|drug: lactose group: placebo
227699|NCT01284959|P1|Participant Flow|Risperidone|Drug: risperidone Groups: risperidone
227700|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
227701|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
227702|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
227703|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
227704|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
227705|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
227706|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
227707|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
227708|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
227709|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
227710|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
227711|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
227712|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
227713|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
227714|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
227715|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
227716|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
227717|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
227718|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
227719|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
227720|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
227721|NCT01284959|E3|Reported Event|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
227722|NCT01284959|E2|Reported Event|Placebo|drug: lactose group: placebo
227723|NCT01284959|E1|Reported Event|Risperidone|Drug: risperidone Groups: risperidone
227724|NCT01284634|B5|Baseline|Total|Total of all reporting groups
227725|NCT01284634|B4|Baseline|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227726|NCT01284634|B3|Baseline|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day.
227727|NCT01284634|B2|Baseline|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day.
227728|NCT01284634|B1|Baseline|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day.
227729|NCT01284634|P4|Participant Flow|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227730|NCT01284634|P3|Participant Flow|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227731|NCT01284634|P2|Participant Flow|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227732|NCT01284634|P1|Participant Flow|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227755|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227733|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227734|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227735|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227736|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227737|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227738|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227739|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227740|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227741|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227742|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227743|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227744|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227745|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227746|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227747|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227748|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227749|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227750|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227751|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227752|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227753|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227754|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
228197|NCT01283516|E9|Reported Event|LDK378 750 mg|LDK378 750 mg
227756|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227757|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227758|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227759|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227760|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227761|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227762|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227763|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227764|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227765|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227766|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227767|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227768|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227769|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227770|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227771|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227772|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227773|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227774|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227775|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227776|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227777|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
228198|NCT01283516|E8|Reported Event|LDK378 700 mg|LDK378 700 mg
227778|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227779|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227780|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227781|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227782|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227783|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227784|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227785|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227786|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227787|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227788|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227789|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227790|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227791|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227792|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227793|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227794|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227795|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227796|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227797|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227798|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227799|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227946|NCT01284491|E2|Reported Event|Traditional Electrosurgery With Scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
227800|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227801|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227802|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227803|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227804|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227805|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227806|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227807|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227808|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227809|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227810|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227811|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227812|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227813|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227814|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227815|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227816|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227817|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227818|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227819|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227820|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227821|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
228199|NCT01283516|E7|Reported Event|LDK378 600 mg|LDK378 600 mg
227822|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227823|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227824|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227825|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227826|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227827|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227828|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227829|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227830|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227831|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227832|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227833|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227834|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227835|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227836|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227837|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227838|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227839|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227840|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227841|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227842|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227843|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 .
227947|NCT01284491|E1|Reported Event|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
227844|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227845|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227846|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227847|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227848|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227849|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227850|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227851|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227852|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227853|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227854|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227855|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227856|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227857|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227858|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227859|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227860|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227861|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227862|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 .
227863|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227864|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227865|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227948|NCT01284426|B1|Baseline|Chronic Urticaria|Chronic urticaria, Natural history
227866|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
227867|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
227868|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
227869|NCT01284634|E4|Reported Event|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
227870|NCT01284634|E3|Reported Event|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day.
227871|NCT01284634|E2|Reported Event|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day.
227872|NCT01284634|E1|Reported Event|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day.
227873|NCT01284621|B1|Baseline|Study Overall|"A randomised, open-label, three period, crossover study. The three treatments administered were
Empagliflozin alone
Ramipril
Empagliflozin plus Ramipril
Each treatment period was 8 days, with drug administration on days 1 to 5, and they were separated by a washout period of at least 7 days between drug administrations of 2 subsequent treatments."
227874|NCT01284621|P6|Participant Flow|Empa + Ramipril / Ramipril Alone / Empa Alone|"Patients were administered three treatments in the following order:
Empagliflozin plus Ramipril
Ramipril
Empagliflozin alone"
227875|NCT01284621|P5|Participant Flow|Empa + Ramipril / Empa Alone / Ramipril Alone|"Patients were administered three treatments in the following order:
Empagliflozin plus Ramipril
Empagliflozin alone
Ramipril"
227876|NCT01284621|P4|Participant Flow|Ramipril Alone / Empa + Ramipril / Empa Alone|"Patients were administered three treatments in the following order:
Ramipril
Empagliflozin plus Ramipril
Empagliflozin alone"
227877|NCT01284621|P3|Participant Flow|Ramipril Alone / Empa Alone / Empa + Ramipril|"Patients were administered three treatments in the following order:
Ramipril
Empagliflozin alone
Empagliflozin plus Ramipril"
227878|NCT01284621|P2|Participant Flow|Empa Alone / Ramipril Alone / Empa + Ramipril|"Patients were administered three treatments in the following order:
Empagliflozin alone
Ramipril
Empagliflozin plus Ramipril"
227879|NCT01284621|P1|Participant Flow|Empa Alone / Empa + Ramipril / Ramipril Alone|"Patients were administered three treatments in the following order:
Empagliflozin alone
Empagliflozin plus Ramipril
Ramipril"
227880|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227881|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227882|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
227883|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227884|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227885|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
227886|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227887|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227888|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
227889|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227890|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227891|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
227892|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227893|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227894|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
227895|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227896|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227897|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
227898|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227899|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227900|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
227901|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227902|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227903|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227904|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
227905|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227906|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227907|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227908|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227909|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227910|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227911|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227912|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227913|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227914|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
227915|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227916|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
227917|NCT01284621|E3|Reported Event|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227918|NCT01284621|E2|Reported Event|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
227919|NCT01284621|E1|Reported Event|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
227920|NCT01284517|B3|Baseline|Total|Total of all reporting groups
227921|NCT01284517|B2|Baseline|Placebo + Li/VPA|
227922|NCT01284517|B1|Baseline|Lurasidone 20-120 mg Flexible Dose+Li/VPA|
227923|NCT01284517|P2|Participant Flow|Placebo + Li/VPA|Placebo + Lithium/divalproex
227924|NCT01284517|P1|Participant Flow|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
227925|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
227926|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
227927|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
227928|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
227929|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
227930|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
227931|NCT01284517|E2|Reported Event|Placebo + Li/VPA|Placebo (PO)+ Lithium/divalproex
227932|NCT01284517|E1|Reported Event|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
227933|NCT01284504|B3|Baseline|Total|Total of all reporting groups
227934|NCT01284504|B2|Baseline|Placebo|"placebo, tab
placebo: Placebo, tab"
227935|NCT01284504|B1|Baseline|Celecoxib|"Celecoxib, 200 mg tab
Celecoxib: 200 mg tablet oral"
227936|NCT01284504|P2|Participant Flow|Placebo|"placebo
placebo"
227937|NCT01284504|P1|Participant Flow|Celocoxib|Celecoxib: 200 mg tablet oral
227938|NCT01284504|O2|Outcome|Placebo|"placebo
placebo"
227939|NCT01284504|O1|Outcome|Celocoxib|Celecoxib: 200 mg tablet oral
227940|NCT01284504|E2|Reported Event|Placebo|"placebo, tab
placebo: Placebo, tab"
227941|NCT01284504|E1|Reported Event|Celecoxib|"Celecoxib, 200 mg tab
Celecoxib: 200 mg tablet oral"
227942|NCT01284491|B1|Baseline|Total Study Population|
227943|NCT01284491|P1|Participant Flow|Total Study Population|
227944|NCT01284491|O2|Outcome|Traditional Electrosurgery With Scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
227945|NCT01284491|O1|Outcome|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
228200|NCT01283516|E6|Reported Event|LDK378 500 mg|LDK378 500 mg
227953|NCT01284361|P1|Participant Flow|Control and Test Crossover|test and control intermittent urinary catheters : randomized cross-over
227954|NCT01284361|O2|Outcome|Test 30 cm Catheter|Test gel lubricated 30 cm catheter identical in all aspects to Control catheter except being 10 cm shorter
227955|NCT01284361|O1|Outcome|Control 40 cm Catheter|Commercial gel lubricated 40 cm catheter
227956|NCT01284361|O1|Outcome|Control and Test Crossover|Control and test intermittent urinary catheters : randomized cross-over
227957|NCT01284361|E2|Reported Event|Test 30 cm Catheter|Test 30 cm gel lubricated cather similar in all aspects except 10 cm shorter length as control catheter
227958|NCT01284361|E1|Reported Event|Control 40 cm Catheter|Commercial 40 cm gel lubricated catheter
227959|NCT01284296|B1|Baseline|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
227960|NCT01284296|P1|Participant Flow|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
227961|NCT01284296|O2|Outcome|Digital Block (Perfusion Indices >2.0)|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss. This is a subgroup of differences with the perfusion index >2.0
227962|NCT01284296|O1|Outcome|Digital Block (All Perfusion Indices 0.29-8.3)|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
227963|NCT01284296|E1|Reported Event|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
227964|NCT01284244|B3|Baseline|Total|Total of all reporting groups
227965|NCT01284244|B2|Baseline|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
227966|NCT01284244|B1|Baseline|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
227967|NCT01284244|P2|Participant Flow|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
227968|NCT01284244|P1|Participant Flow|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
227969|NCT01284244|O2|Outcome|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
227970|NCT01284244|O1|Outcome|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
227971|NCT01284244|E2|Reported Event|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
228016|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228017|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228018|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227972|NCT01284244|E1|Reported Event|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
227973|NCT01284114|B1|Baseline|Aliskiren|
227974|NCT01284114|P1|Participant Flow|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
227975|NCT01284114|O1|Outcome|Aliskiren|
227976|NCT01284114|O1|Outcome|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
227977|NCT01284114|O1|Outcome|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
227978|NCT01284114|O1|Outcome|Aliskiren|
227979|NCT01284114|O1|Outcome|Aliskiren|
227980|NCT01284114|E1|Reported Event|Aliskiren|
227981|NCT01284062|B5|Baseline|Total|Total of all reporting groups
227982|NCT01284062|B4|Baseline|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227983|NCT01284062|B3|Baseline|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227984|NCT01284062|B2|Baseline|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227985|NCT01284062|B1|Baseline|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227986|NCT01284062|P4|Participant Flow|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227987|NCT01284062|P3|Participant Flow|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227988|NCT01284062|P2|Participant Flow|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227989|NCT01284062|P1|Participant Flow|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227990|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227991|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227992|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227993|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227994|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227995|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227996|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227997|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227998|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
227999|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228000|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228001|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228002|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228003|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228004|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228005|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228006|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228007|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228008|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228009|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228010|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228011|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228012|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228013|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228014|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228015|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228019|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228020|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228021|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228022|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228023|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228024|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228025|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228026|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228027|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228028|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228029|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228030|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228031|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228032|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228033|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228034|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228035|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228036|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228037|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228038|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228039|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228040|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228041|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228042|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228043|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228044|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228045|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228046|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228047|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228048|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228049|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228050|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228051|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228052|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228053|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228054|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228055|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228056|NCT01284062|E4|Reported Event|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228057|NCT01284062|E3|Reported Event|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228058|NCT01284062|E2|Reported Event|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228059|NCT01284062|E1|Reported Event|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
228060|NCT01283971|B3|Baseline|Total|Total of all reporting groups
228061|NCT01283971|B2|Baseline|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228062|NCT01283971|B1|Baseline|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228063|NCT01283971|P2|Participant Flow|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228064|NCT01283971|P1|Participant Flow|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228065|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228066|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228067|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228068|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228069|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228070|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228071|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228072|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228073|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228074|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228075|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228076|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228077|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228078|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228079|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228080|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228081|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228082|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228083|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228084|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228085|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228086|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228087|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228088|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228089|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228090|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228091|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228092|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228093|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228094|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228095|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228096|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228097|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228098|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228099|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228100|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228101|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228102|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228103|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228104|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228105|NCT01283971|E2|Reported Event|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228106|NCT01283971|E1|Reported Event|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
228107|NCT01283581|B4|Baseline|Total|Total of all reporting groups
228108|NCT01283581|B3|Baseline|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
228109|NCT01283581|B2|Baseline|Linezolid|Linezolid 600 mg, BID
228110|NCT01283581|B1|Baseline|Delafloxacin IV|Delafloxacin 300 mg, BID
228111|NCT01283581|P3|Participant Flow|Vancomycin IV|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
228112|NCT01283581|P2|Participant Flow|Linezolid IV|Linezolid 600 mg, BID
228113|NCT01283581|P1|Participant Flow|Delafloxacin IV|Delafloxacin 300 mg, BID
228114|NCT01283581|O3|Outcome|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
228115|NCT01283581|O2|Outcome|Linezolid|Linezolid 600 mg, BID
228116|NCT01283581|O1|Outcome|Delafloxacin IV|Delafloxacin 300 mg, BID
228117|NCT01283581|O3|Outcome|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
228118|NCT01283581|O2|Outcome|Linezolid|Linezolid 600 mg, BID
228119|NCT01283581|O1|Outcome|Delafloxacin IV|Delafloxacin 300 mg, BID
228120|NCT01283581|E3|Reported Event|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
228121|NCT01283581|E2|Reported Event|Linezolid|Linezolid 600 mg, BID
228122|NCT01283581|E1|Reported Event|Delafloxacin IV|Delafloxacin 300 mg, BID
228123|NCT01283555|B1|Baseline|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
228124|NCT01283555|P2|Participant Flow|Prefilled Applicator First, Then User-filled|Plastic applicator (prefilled with Tenofovir 1% gel) used twice daily in first intervention period and user-filled applicator used twice daily in second intervention period (after washout period)
228125|NCT01283555|P1|Participant Flow|User-Filled Applicator First, Then Prefilled|User-filled paper applicator (filled using a tube of Tenofovir 1% gel)used twice daily in first intervention period and prefilled applicator used twice daily in second intervention period (after washout period)
228126|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
228127|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
228128|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
228129|NCT01283555|O2|Outcome|Colposcopic Findings After 7 Days of Product Use|Number of colposcopic findings identified during colposcopy after one week of twice daily product use (data from both study arms are combined). Note: Since a participant can have more than one colposcopic finding, the number of colposcopic findings does not necessarily equal the number of participants with colposcopic findings.
228130|NCT01283555|O1|Outcome|Baseline Colposcopic Findings|Number of colposcopic findings identified during baseline colposcopies for both study arms. Note: Since a participant can have more than one colposcopic finding, the number of colposcopic findings does not necessarily equal the number of participants with colposcopic findings.
228131|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
228132|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
228133|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228134|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228135|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228136|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228137|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228138|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228139|NCT01283555|O3|Outcome|Same|no preference between user-filled or prefilled applicator
228140|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228141|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228142|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228143|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228144|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228145|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228146|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228147|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228148|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228149|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228150|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228151|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228152|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228153|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228154|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228155|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228156|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228157|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228158|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228159|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228160|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228161|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228162|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228163|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228164|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228165|NCT01283555|E2|Reported Event|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
228166|NCT01283555|E1|Reported Event|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
228167|NCT01283516|B10|Baseline|Total|Total of all reporting groups
228168|NCT01283516|B9|Baseline|750 mg|Participants receiving 750 mg of LDK378
228169|NCT01283516|B8|Baseline|700 mg|Participants receiving 700 mg of LDK378
228170|NCT01283516|B7|Baseline|600 mg|Participants receiving 600 mg of LDK378
228171|NCT01283516|B6|Baseline|500 mg|Participants receiving 500 mg of LDK378
228172|NCT01283516|B5|Baseline|400 mg|Participants receiving 400 mg of LDK378
228173|NCT01283516|B4|Baseline|300 mg|Participants receiving 300 mg of LDK378
228174|NCT01283516|B3|Baseline|200 mg|Participants receiving 200 mg of LDK378
228175|NCT01283516|B2|Baseline|100 mg|Participants receiving 100 mg of LDK378
228176|NCT01283516|B1|Baseline|50 mg|Participants receiving 50 mg of LDK378
228177|NCT01283516|P9|Participant Flow|750 mg|Participants receiving 750 mg of LDK378
228178|NCT01283516|P8|Participant Flow|700 mg|Participants receiving 700 mg of LDK378
228179|NCT01283516|P7|Participant Flow|600 mg|Participants receiving 600 mg of LDK378
228180|NCT01283516|P6|Participant Flow|500 mg|Participants receiving 500 mg of LDK378
228181|NCT01283516|P5|Participant Flow|400 mg|Participants receiving 400 mg of LDK378
228182|NCT01283516|P4|Participant Flow|300 mg|Participants receiving 300 mg of LDK378
228183|NCT01283516|P3|Participant Flow|200 mg|Participants receiving 200 mg of LDK378
228184|NCT01283516|P2|Participant Flow|100 mg|Participants receiving 100 mg of LDK378
228185|NCT01283516|P1|Participant Flow|50 mg|Participants receiving 50 mg of LDK378
228186|NCT01283516|O1|Outcome|NSCLC With Prior Crizotinib|NSCLC patients who received prior crizotinib in the 750 mg dose group.
228187|NCT01283516|O1|Outcome|NSCLC With Prior Crizotinib|NSCLC patients who received prior crizotinib in the 750 mg dose group.
228188|NCT01283516|O9|Outcome|LDK378 750|Participants receiving 750 mg of LDK378.
228189|NCT01283516|O8|Outcome|LDK378 700 mg|Participants receiving 700 mg of LDK378
228190|NCT01283516|O7|Outcome|LDK378 600 mg|Participants receiving 600 mg of LDK378
228191|NCT01283516|O6|Outcome|LDK378 500 mg|Participants receiving 500 mg of LDK378
228192|NCT01283516|O5|Outcome|LDK378 400 mg|Participants receiving 400 mg of LDK378
228193|NCT01283516|O4|Outcome|LDK378 300 mg|Participants receiving 300 mg of LDK378
228209|NCT01283464|P2|Participant Flow|Tretinoin|Tretinoin 0.02% cream to entire face daily or as tolerated for 6 months
228210|NCT01283464|P1|Participant Flow|Retinol|Retinol 1.0% cream to entire face daily or as tolerated for 6 months
228211|NCT01283464|O2|Outcome|Tretinoin|Tretinoin 0.02% cream
228212|NCT01283464|O1|Outcome|Retinol|Retinol 1.0% cream
228213|NCT01283464|E2|Reported Event|Tretinoin|Tretinoin 0.02% cream
228214|NCT01283464|E1|Reported Event|Retinol|Retinol 1.0% cream
228215|NCT01283334|B1|Baseline|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)
Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
228216|NCT01283334|P1|Participant Flow|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)
Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
228217|NCT01283334|O1|Outcome|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)
Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
228218|NCT01283334|O2|Outcome|Everolimus Dose Level -1 DLT|Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level -1 (2.5 mg every other day)
228219|NCT01283334|O1|Outcome|Everolimus Dose Level 1 DLT|Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level 1 (2.5 mg/day)
228220|NCT01283334|E1|Reported Event|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)
Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
228221|NCT01283321|B3|Baseline|Total|Total of all reporting groups
228222|NCT01283321|B2|Baseline|Group B: Apheresis Platelets|"single apheresis unit
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
228223|NCT01283321|B1|Baseline|Group A: RiaSTAP|"Human fibrinogen concentrate
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
228224|NCT01283321|P2|Participant Flow|Group B: Apheresis Platelets|apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
228225|NCT01283321|P1|Participant Flow|Group A: RiaSTAP|Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
228226|NCT01283321|O2|Outcome|Group B: Apheresis Platelets|"single apheresis unit
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
228227|NCT01283321|O1|Outcome|Group A: RiaSTAP|"Human fibrinogen concentrate
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
228228|NCT01283321|E2|Reported Event|Group B: Apheresis Platelets|"single apheresis unit
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
228229|NCT01283321|E1|Reported Event|Group A: RiaSTAP|"Human fibrinogen concentrate
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
228230|NCT01283282|B1|Baseline|All Subjects|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
228231|NCT01283282|P2|Participant Flow|Clopidogrel First/Then Placebo|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks then were switched to placebo PO qd therapy for an additional 6 weeks without any wash out period in between.
228232|NCT01283282|P1|Participant Flow|Placebo First/Then Clopidogrel|The subjects received placebo PO qd for the first 6 weeks then were switched to clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
228233|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
228234|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
228235|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
228236|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
228237|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
228238|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
228239|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
228240|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
228241|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
228242|NCT01283282|O1|Outcome|Clopidogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
228243|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
228244|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
228245|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
228246|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
228368|NCT01282710|B1|Baseline|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
228247|NCT01283282|E2|Reported Event|Placebo|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
228248|NCT01283282|E1|Reported Event|Clopidogrel|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
228249|NCT01283152|B3|Baseline|Total|Total of all reporting groups
228250|NCT01283152|B2|Baseline|Lactulose|"Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
228251|NCT01283152|B1|Baseline|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
228252|NCT01283152|P2|Participant Flow|Lactulose|"Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
228253|NCT01283152|P1|Participant Flow|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
228254|NCT01283152|O2|Outcome|Lactulose|"Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
228255|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
228256|NCT01283152|O2|Outcome|Lactulose|"Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
228257|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
228258|NCT01283152|O2|Outcome|Lactulose|"Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
228259|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
228260|NCT01283152|E2|Reported Event|Lactulose|"Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
228261|NCT01283152|E1|Reported Event|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
228262|NCT01283139|B5|Baseline|Total|Total of all reporting groups
228263|NCT01283139|B4|Baseline|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228264|NCT01283139|B3|Baseline|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228265|NCT01283139|B2|Baseline|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228266|NCT01283139|B1|Baseline|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228267|NCT01283139|P4|Participant Flow|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228268|NCT01283139|P3|Participant Flow|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228269|NCT01283139|P2|Participant Flow|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228270|NCT01283139|P1|Participant Flow|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228271|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228272|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228273|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228274|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228275|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228276|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228277|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228369|NCT01282710|P1|Participant Flow|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
241955|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
228278|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228279|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228280|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228281|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228282|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228283|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228284|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228285|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228286|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228287|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228288|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228289|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228290|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228291|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228292|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228293|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228294|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228295|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228296|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228297|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228298|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228299|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228300|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228301|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228302|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228303|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228304|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228370|NCT01282710|O1|Outcome|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
228305|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228306|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
228307|NCT01283139|E4|Reported Event|Sifalimumab 1200 mg|Sifalimumab 1,200 mg administered intravenously for 48 weeks (Day 337).
228308|NCT01283139|E3|Reported Event|Sifalimumab 600 mg|Sifalimumab 600 mg administered intravenously for 48 weeks (Day 337).
228309|NCT01283139|E2|Reported Event|Sifalimumab 200 mg|Sifalimumab 200 milligram (mg) administered intravenously for 48 weeks (Day 337).
228310|NCT01283139|E1|Reported Event|Placebo|Placebo matching to sifalimumab administered intravenously for 48 weeks (Day 337).
228311|NCT01283035|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
228312|NCT01283035|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
228313|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
228314|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
228315|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
228316|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
228317|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
228318|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
228319|NCT01283035|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
228320|NCT01283022|B1|Baseline|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
228321|NCT01283022|P1|Participant Flow|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
228322|NCT01283022|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
228323|NCT01283022|O1|Outcome|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
228324|NCT01283022|O1|Outcome|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
228325|NCT01283022|E1|Reported Event|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
228326|NCT01282866|B1|Baseline|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:
Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels.
All patients were treated in the Axilla area."
228327|NCT01282866|P1|Participant Flow|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:
Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels.
All patients were treated in the Axilla area."
228328|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:
Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.
All patients were treated in the Axilla area."
228329|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:
Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.
All patients were treated in the Axilla area."
228330|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:
Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.
All patients were treated in the Axilla area."
228331|NCT01282866|E1|Reported Event|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:
Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.
All patients were treated in the Axilla area."
228332|NCT01282814|B3|Baseline|Total|Total of all reporting groups
228333|NCT01282814|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
228334|NCT01282814|B1|Baseline|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
228335|NCT01282814|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
228336|NCT01282814|P1|Participant Flow|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
228337|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
228338|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
228339|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
228340|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
228341|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
228342|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
228343|NCT01282814|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
228344|NCT01282814|E1|Reported Event|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
228345|NCT01282801|B3|Baseline|Total|Total of all reporting groups
228346|NCT01282801|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
228347|NCT01282801|B1|Baseline|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
228348|NCT01282801|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
228349|NCT01282801|P1|Participant Flow|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
228350|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
228351|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
228352|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
228353|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
228354|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
228355|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
228356|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
228357|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
228358|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
228359|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
228360|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
228361|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
228362|NCT01282801|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
228363|NCT01282801|E1|Reported Event|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
228364|NCT01282723|B1|Baseline|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
228365|NCT01282723|P1|Participant Flow|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
228366|NCT01282723|O1|Outcome|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
228367|NCT01282723|E1|Reported Event|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
241956|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
228371|NCT01282710|E1|Reported Event|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
228372|NCT01282476|B1|Baseline|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
228373|NCT01282476|P1|Participant Flow|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
228374|NCT01282476|O1|Outcome|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
228375|NCT01282476|O1|Outcome|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
228376|NCT01282476|O1|Outcome|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
228377|NCT01282476|E1|Reported Event|Panobinostat/Rituximab|"single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles."
228378|NCT01282424|B1|Baseline|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228379|NCT01282424|P1|Participant Flow|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228380|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228381|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228382|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228383|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228384|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228385|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228386|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228387|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228388|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228389|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228390|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228391|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228392|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228393|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228394|NCT01282424|E1|Reported Event|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
228395|NCT01282372|B1|Baseline|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
228396|NCT01282372|P1|Participant Flow|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
228397|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
228398|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
228399|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
228400|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
228401|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
228402|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
228403|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
228404|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
228405|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
228406|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
228498|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228407|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
228408|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
228409|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
228410|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
228411|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
228412|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
228413|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
228414|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
228415|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
228416|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
228417|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
228418|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
228419|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
228420|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
228421|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
228422|NCT01282372|E1|Reported Event|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
228423|NCT01282294|B1|Baseline|ETN PROtect|"There is only 1 cohort in this case series.
ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating"
228424|NCT01282294|P1|Participant Flow|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228425|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228426|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228427|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228428|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228429|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228430|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228431|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228432|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228433|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228434|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228435|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228436|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228437|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228438|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228439|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228440|NCT01282294|E1|Reported Event|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
228441|NCT01282242|B3|Baseline|Total|Total of all reporting groups
228442|NCT01282242|B2|Baseline|SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
228443|NCT01282242|B1|Baseline|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
228444|NCT01282242|P2|Participant Flow|Secondary SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
228445|NCT01282242|P1|Participant Flow|Primary SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
228446|NCT01282242|O2|Outcome|SIR < 1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
228447|NCT01282242|O1|Outcome|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
228448|NCT01282242|O2|Outcome|SIR < 1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
228499|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228449|NCT01282242|O1|Outcome|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
228450|NCT01282242|E2|Reported Event|SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
228451|NCT01282242|E1|Reported Event|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
228452|NCT01282229|B1|Baseline|All Participants|Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
228453|NCT01282229|P1|Participant Flow|All Participants|Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
228454|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
228455|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
228456|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
228457|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP
LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
228458|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
228459|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
228460|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
228461|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP
LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
228462|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
228463|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
228464|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
228465|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP
LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
228466|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
228467|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
228468|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
228469|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP
LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
228470|NCT01282229|O8|Outcome|Coronal Debridement (≥7mm Pockets)|Quadrant treated with coronal debridement
228471|NCT01282229|O7|Outcome|Coronal Debridement (5-6mm Pockets)|Quadrant treated with coronal debridement
228472|NCT01282229|O6|Outcome|Scaling and Root Planing (≥7mm Pockets)|Quadrant treated with scaling and root planing alone
228473|NCT01282229|O5|Outcome|Scaling and Root Planing (5-6mm Pockets)|Quadrant treated with scaling and root planing alone
228474|NCT01282229|O4|Outcome|Modified Widman Flap (≥7mm Pockets)|Quadrant treated with Modified Widman Flap surgery
228475|NCT01282229|O3|Outcome|Modified Widman Flap (5-6mm Pockets)|Quadrant treated with Modified Widman Flap surgery
228476|NCT01282229|O2|Outcome|LANAP Quadrant (≥7mm Pockets)|"Treated with LANAP
LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
228477|NCT01282229|O1|Outcome|LANAP Quadrant (5-6mm Pockets)|"Treated with LANAP
LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
228478|NCT01282229|E4|Reported Event|Coronal Debridement|Quadrant treated with coronal debridement
228479|NCT01282229|E3|Reported Event|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
228480|NCT01282229|E2|Reported Event|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
228481|NCT01282229|E1|Reported Event|LANAP Quadrant|"Treated with LANAP
LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
228482|NCT01282203|B1|Baseline|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228483|NCT01282203|P1|Participant Flow|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228484|NCT01282203|O3|Outcome|Anesthesia With Sevorane|Duration of experience with Sevorane.
228485|NCT01282203|O2|Outcome|Inhalation Anesthesia|Duration of experience with inhalation anesthesia.
228486|NCT01282203|O1|Outcome|General Anesthesia|Duration of experience with general anesthesia.
228487|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228488|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228489|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228490|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228491|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228492|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228493|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228494|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228495|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228496|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228497|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
230089|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
228500|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228501|NCT01282203|E1|Reported Event|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228502|NCT01282164|B3|Baseline|Total|Total of all reporting groups
228503|NCT01282164|B2|Baseline|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
228504|NCT01282164|B1|Baseline|Study Patients|"patients with growth hormone deficiency or hypothalamic-pituitary disorders
Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
228505|NCT01282164|P2|Participant Flow|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
228506|NCT01282164|P1|Participant Flow|Study Patients|"patients with growth hormone deficiency or hypothalamic-pituitary disorders
Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg adrenocorticotropin hormone (ACTH) stimulation test in subjects with type 2 diabetes mellitus (T2DM), coronary artery disease (CAD), cerebrovascular disease (CVD), seizure"
228507|NCT01282164|O1|Outcome|Patients Older Than 65|Three patients with adult onset hypothalamic-pituitary disease underwent who were older than 65 years of age underwent ACTH stimulation test instead of ITT.
228508|NCT01282164|O3|Outcome|Patients With 3 or More PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
228509|NCT01282164|O2|Outcome|Patients With 3 or More PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
228510|NCT01282164|O1|Outcome|Patients With 3 or More PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
228511|NCT01282164|O3|Outcome|Control Group- Weight-based GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
228512|NCT01282164|O2|Outcome|Control Group- Fixed-dose GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
228513|NCT01282164|O1|Outcome|Control Group- ITT|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site did not enroll the control group. All underwent insulin tolerance test using 0.10-0.15 U/kg
228514|NCT01282164|O3|Outcome|Patients With 1-2 PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
228515|NCT01282164|O2|Outcome|Patients With 1-2 PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
228516|NCT01282164|O1|Outcome|Patients With 1-2 PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
228517|NCT01282164|O3|Outcome|Patients With 3 or More PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
228518|NCT01282164|O2|Outcome|Patients With 3 or More PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
228519|NCT01282164|O1|Outcome|Patients With 3 or More PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
228520|NCT01282164|O3|Outcome|Control Group- Weight-based GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
228521|NCT01282164|O2|Outcome|Control Group- Fixed-dose GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
228522|NCT01282164|O1|Outcome|Control Group- ITT|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site did not enroll the control group. All underwent insulin tolerance test using 0.10-0.15 U/kg
228523|NCT01282164|O3|Outcome|Patients With 1-2 PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
228524|NCT01282164|O2|Outcome|Patients With 1-2 PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
228525|NCT01282164|O1|Outcome|Patients With 1-2 PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
228526|NCT01282164|E2|Reported Event|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
228527|NCT01282164|E1|Reported Event|Study Patients|"patients with hypothalamic-pituitary disorders
Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
228528|NCT01282138|B3|Baseline|Total|Total of all reporting groups
228529|NCT01282138|B2|Baseline|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
228530|NCT01282138|B1|Baseline|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
228531|NCT01282138|P2|Participant Flow|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
228532|NCT01282138|P1|Participant Flow|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
228533|NCT01282138|O2|Outcome|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
228534|NCT01282138|O1|Outcome|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
228535|NCT01282138|O2|Outcome|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
228536|NCT01282138|O1|Outcome|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
228537|NCT01282138|E2|Reported Event|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
228538|NCT01282138|E1|Reported Event|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
228539|NCT01282086|B1|Baseline|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228540|NCT01282086|P1|Participant Flow|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228541|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228542|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228543|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228544|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228545|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228546|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228547|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228548|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228549|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery.
228550|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228551|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228552|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228553|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228554|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228555|NCT01282086|E1|Reported Event|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
228556|NCT01281917|B1|Baseline|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Treat for up to 6 cycles, cycles are 35 days long.
Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
228557|NCT01281917|P1|Participant Flow|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Treat for up to 6 cycles, cycles are 35 days long.
Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
228558|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Treat for up to 6 cycles, cycles are 35 days long.
Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
228559|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Treat for up to 6 cycles, cycles are 35 days long.
Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
228560|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Treat for up to 6 cycles, cycles are 35 days long.
Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
228561|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Treat for up to 6 cycles, cycles are 35 days long.
Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
230179|NCT01276509|E4|Reported Event|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
228562|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Treat for up to 6 cycles, cycles are 35 days long.
Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
228563|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Treat for up to 6 cycles, cycles are 35 days long.
Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
228564|NCT01281917|O1|Outcome|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Treat for up to 6 cycles, cycles are 35 days long.
Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
228565|NCT01281917|E1|Reported Event|Velcade Plus Temsirolimus|"Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Treat for up to 6 cycles, cycles are 35 days long.
Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)"
228566|NCT01281865|B3|Baseline|Total|Total of all reporting groups
228567|NCT01281865|B2|Baseline|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
228568|NCT01281865|B1|Baseline|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
228569|NCT01281865|P2|Participant Flow|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
228570|NCT01281865|P1|Participant Flow|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
228571|NCT01281865|O2|Outcome|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
228572|NCT01281865|O1|Outcome|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
228573|NCT01281865|E2|Reported Event|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
228574|NCT01281865|E1|Reported Event|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
228575|NCT01281839|B3|Baseline|Total|Total of all reporting groups
228576|NCT01281839|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228577|NCT01281839|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228578|NCT01281839|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228579|NCT01281839|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228580|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228581|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228582|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228583|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228584|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228585|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228586|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228587|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228588|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228589|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228590|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228591|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228592|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228593|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228594|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228595|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228596|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228597|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228598|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228599|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228600|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228601|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228602|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228603|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228604|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228605|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228606|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228607|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228661|NCT01281501|E1|Reported Event|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
228662|NCT01281475|B3|Baseline|Total|Total of all reporting groups
228608|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228609|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228610|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228611|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228612|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228613|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228614|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228615|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228616|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228617|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228618|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228619|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228620|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228621|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228622|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228623|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228624|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228625|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228626|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228627|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228663|NCT01281475|B2|Baseline|Placebo|"The placebo (in this study, microcellulose) is not expected to have any effect.
It is also taken 3 times a day, just like Levodopa."
241957|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
228628|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228629|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228630|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228631|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228632|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228633|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228634|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228635|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228636|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228637|NCT01281839|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
228638|NCT01281839|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
228639|NCT01281644|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm.
Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site."
228640|NCT01281644|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm.
Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site."
228641|NCT01281644|O2|Outcome|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.
Diode Laser: 810 nm diode laser"
228642|NCT01281644|O1|Outcome|No Laser Treatment|
228643|NCT01281644|O2|Outcome|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.
Diode Laser: 810 nm diode laser"
228644|NCT01281644|O1|Outcome|No Laser Treatment|
228645|NCT01281644|E2|Reported Event|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.
Diode Laser: 810 nm diode laser"
228646|NCT01281644|E1|Reported Event|No Laser Treatment|
228647|NCT01281501|B3|Baseline|Total|Total of all reporting groups
228648|NCT01281501|B2|Baseline|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
228649|NCT01281501|B1|Baseline|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
228650|NCT01281501|P2|Participant Flow|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
228651|NCT01281501|P1|Participant Flow|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
228652|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
228653|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
228654|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
228655|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
228656|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
228657|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
228658|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
228659|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
228660|NCT01281501|E2|Reported Event|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
228664|NCT01281475|B1|Baseline|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.
Levodopa/carbidopa: Levodopa/Carbidopa (4:1)
Dosages are based on levodopa.
Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
228665|NCT01281475|P2|Participant Flow|Placebo|The placebo (in this study, microcellulose) is not expected to have any effect.
228666|NCT01281475|P1|Participant Flow|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.
Levodopa/carbidopa: Levodopa/Carbidopa (4:1)
Dosages are based on levodopa.
Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
228667|NCT01281475|O2|Outcome|Placebo|"The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa, so it is not expected to have any effect.
Placebo Oral Capsule: The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa."
228668|NCT01281475|O1|Outcome|Levodopa|"Levodopa is prescribed as a combination of levodopa/carbidopa (4:1) to reduce the peripheral side effects. The dosage used was 15 mg/kg/day in 3 divided doses.
Levodopa: Levodopa/Carbidopa (4:1)
Dosages are based on levodopa.
Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
228669|NCT01281475|O2|Outcome|Placebo|"The placebo (in this study, microcellulose) is not expected to have any effect.
The placebo capsules are taken 3 times a day, just like the levodopa / carbidopa capsules"
228670|NCT01281475|O1|Outcome|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.
Levodopa/carbidopa: Levodopa/Carbidopa (4:1)
Dosages are based on levodopa.
Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
228671|NCT01281475|E2|Reported Event|Placebo|The placebo (in this study, microcellulose) is not expected to have any effect.
228672|NCT01281475|E1|Reported Event|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.
Levodopa/carbidopa: Levodopa/Carbidopa (4:1)
Dosages are based on levodopa.
Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
228673|NCT01281306|B8|Baseline|Total|Total of all reporting groups
228674|NCT01281306|B7|Baseline|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228675|NCT01281306|B6|Baseline|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228676|NCT01281306|B5|Baseline|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228677|NCT01281306|B4|Baseline|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228678|NCT01281306|B3|Baseline|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228679|NCT01281306|B2|Baseline|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228680|NCT01281306|B1|Baseline|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228681|NCT01281306|P7|Participant Flow|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228682|NCT01281306|P6|Participant Flow|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228683|NCT01281306|P5|Participant Flow|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228684|NCT01281306|P4|Participant Flow|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228685|NCT01281306|P3|Participant Flow|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228686|NCT01281306|P2|Participant Flow|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228687|NCT01281306|P1|Participant Flow|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
241958|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
228688|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228689|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228690|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228691|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228692|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228693|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228694|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228695|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228696|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228697|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228698|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228699|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228700|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228701|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228702|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228703|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228704|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228705|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228706|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228707|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228708|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228709|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228710|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228711|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228712|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228713|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228714|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228715|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228716|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228717|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228718|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228719|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228720|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228721|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228722|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228723|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228724|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228725|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228726|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228727|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228728|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228729|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228730|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228731|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228732|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228733|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228734|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228735|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228736|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228737|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228738|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228739|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228740|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228741|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228742|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228743|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228744|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228745|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228746|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228747|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228748|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228749|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228750|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228751|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228752|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228753|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228754|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228755|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228756|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228757|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228758|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228759|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228760|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228761|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228762|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228763|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228764|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228765|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228766|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228767|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228768|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228769|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228770|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228771|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228772|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228773|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228774|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228775|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228776|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228777|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228778|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228779|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228780|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228781|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228782|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228783|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228784|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228785|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228786|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228787|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228788|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228789|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228790|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228791|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228792|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228793|NCT01281306|E7|Reported Event|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
228794|NCT01281306|E6|Reported Event|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
228795|NCT01281306|E5|Reported Event|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
228796|NCT01281306|E4|Reported Event|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
228797|NCT01281306|E3|Reported Event|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
228798|NCT01281306|E2|Reported Event|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
228799|NCT01281306|E1|Reported Event|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
228800|NCT01281202|B3|Baseline|Total|Total of all reporting groups
228801|NCT01281202|B2|Baseline|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
228802|NCT01281202|B1|Baseline|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
228803|NCT01281202|P2|Participant Flow|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
228804|NCT01281202|P1|Participant Flow|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
228805|NCT01281202|O2|Outcome|Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase
During treatment, subject received Vigabatrin matching placebo tablets, bid, for 9 weeks
Subject were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
228806|NCT01281202|O1|Outcome|CPP-109 Vigabatrin Tablets|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase
During treatment, subject received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks
Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
228807|NCT01281202|O2|Outcome|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During Treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks.
Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
228808|NCT01281202|O1|Outcome|CPP-109 Vigabatrin Tablets|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks.
Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
228809|NCT01281202|E2|Reported Event|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
228810|NCT01281202|E1|Reported Event|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
228811|NCT01281124|B1|Baseline|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
228812|NCT01281124|P1|Participant Flow|Treatment (5-Azacytidine)|Patients receive 5-azacitidine subcutaneously at the starting dose level of 75 mg/m2 on an outpatient basis daily for 7 days on a 28 day cycle.
228813|NCT01281124|O1|Outcome|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
228814|NCT01281124|O1|Outcome|Treatment (5-Azacytidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
228815|NCT01281124|O1|Outcome|Treatment (5-Azacyitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
228816|NCT01281124|E1|Reported Event|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
228817|NCT01281007|B3|Baseline|Total|Total of all reporting groups
228818|NCT01281007|B2|Baseline|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days
Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
228819|NCT01281007|B1|Baseline|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days
Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
228820|NCT01281007|P2|Participant Flow|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days
Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
228821|NCT01281007|P1|Participant Flow|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days
Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
228822|NCT01281007|O2|Outcome|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days
Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
228823|NCT01281007|O1|Outcome|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days
Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
228824|NCT01281007|E2|Reported Event|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days
Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
228825|NCT01281007|E1|Reported Event|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days
Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
228826|NCT01280981|B1|Baseline|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
229024|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
228827|NCT01280981|P1|Participant Flow|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
228828|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
228829|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
228830|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
228831|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
228832|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
228833|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
228834|NCT01280981|E1|Reported Event|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
228835|NCT01280968|B3|Baseline|Total|Total of all reporting groups
228836|NCT01280968|B2|Baseline|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
228837|NCT01280968|B1|Baseline|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
228838|NCT01280968|P2|Participant Flow|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
228839|NCT01280968|P1|Participant Flow|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
228840|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
228841|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
228842|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
228843|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
228844|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
228845|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
228846|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
228847|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
228848|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
228849|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
228850|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
228851|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
228852|NCT01280968|E2|Reported Event|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
228853|NCT01280968|E1|Reported Event|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
228854|NCT01280955|B1|Baseline|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228855|NCT01280955|P1|Participant Flow|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228856|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
229025|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
228857|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228858|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228859|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228860|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228861|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228862|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228863|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228864|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228865|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228866|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228867|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228868|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228869|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228870|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228871|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228872|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228873|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228874|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228875|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228876|NCT01280955|O1|Outcome|Transplant Recipients|"Transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
Plerixafor: Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs."
228877|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228878|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228879|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228880|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
241959|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
228881|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228882|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228883|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
228884|NCT01280955|E1|Reported Event|Transplant Recipients|"This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
Adverse Events were monitored for 29 transplant recipients"
228885|NCT01280695|B6|Baseline|Total|Total of all reporting groups
228886|NCT01280695|B5|Baseline|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
228887|NCT01280695|B4|Baseline|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
228888|NCT01280695|B3|Baseline|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
228889|NCT01280695|B2|Baseline|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
228890|NCT01280695|B1|Baseline|Placebo|Placebo capsule once daily
228891|NCT01280695|P5|Participant Flow|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
228892|NCT01280695|P4|Participant Flow|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
228893|NCT01280695|P3|Participant Flow|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
228894|NCT01280695|P2|Participant Flow|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
228895|NCT01280695|P1|Participant Flow|Placebo|Placebo capsule once daily
228896|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
228897|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
228898|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
228899|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
228900|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
228901|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
228902|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
228903|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
228904|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
228905|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
228906|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
228907|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
228908|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
228909|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
228910|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
228911|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
228912|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
228913|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
228914|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
228915|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
228916|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
228917|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
228918|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
228919|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
228920|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
228921|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
228922|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
228923|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
228924|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
228925|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
228926|NCT01280695|E5|Reported Event|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
228927|NCT01280695|E4|Reported Event|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
228928|NCT01280695|E3|Reported Event|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
228929|NCT01280695|E2|Reported Event|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
228930|NCT01280695|E1|Reported Event|Placebo|Placebo capsule once daily
228931|NCT01280656|B4|Baseline|Total|Total of all reporting groups
228932|NCT01280656|B3|Baseline|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228933|NCT01280656|B2|Baseline|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228934|NCT01280656|B1|Baseline|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228935|NCT01280656|P3|Participant Flow|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
229023|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
228936|NCT01280656|P2|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228937|NCT01280656|P1|Participant Flow|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228938|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228939|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228940|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228941|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228942|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228943|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228944|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228945|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228946|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228947|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228948|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228949|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228950|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228951|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228952|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228953|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228954|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228955|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228956|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228957|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228958|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228959|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228960|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228961|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228962|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228963|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228964|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228965|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228966|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228967|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228968|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228969|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228970|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228971|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228972|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228973|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228974|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228975|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228976|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
228977|NCT01280656|E3|Reported Event|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
228978|NCT01280656|E2|Reported Event|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy
228979|NCT01280656|E1|Reported Event|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
228980|NCT01280604|B3|Baseline|Total|Total of all reporting groups
228981|NCT01280604|B2|Baseline|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
228982|NCT01280604|B1|Baseline|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
228983|NCT01280604|P2|Participant Flow|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
228984|NCT01280604|P1|Participant Flow|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
228985|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
228986|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
228987|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
228988|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
228989|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
228990|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
228991|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
228992|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
228993|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
228994|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
228995|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
228996|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
228997|NCT01280604|E2|Reported Event|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
228998|NCT01280604|E1|Reported Event|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
228999|NCT01280591|B5|Baseline|Total|Total of all reporting groups
229000|NCT01280591|B4|Baseline|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229001|NCT01280591|B3|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229002|NCT01280591|B2|Baseline|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229003|NCT01280591|B1|Baseline|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229004|NCT01280591|P4|Participant Flow|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229005|NCT01280591|P3|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229006|NCT01280591|P2|Participant Flow|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229007|NCT01280591|P1|Participant Flow|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229008|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229009|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229010|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229011|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229012|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229013|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229014|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229015|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229016|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229017|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229018|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229019|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229020|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229021|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229022|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
241960|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
229026|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229027|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229028|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229029|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229030|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229031|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229032|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229033|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229034|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229035|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229036|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229037|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229038|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229039|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229040|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229041|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229042|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229043|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229044|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229045|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229046|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229047|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229048|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229049|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229050|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229051|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229052|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229053|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229054|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229055|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229056|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229057|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229058|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229059|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229060|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229061|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229062|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229063|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229064|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229065|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229066|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229067|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229068|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229069|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229070|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229071|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229072|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229073|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229074|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229075|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229076|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229077|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229078|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229079|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229080|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229081|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229082|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229083|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229084|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229085|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229086|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229087|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229088|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229089|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229090|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229091|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229092|NCT01280591|E4|Reported Event|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
229093|NCT01280591|E3|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
229094|NCT01280591|E2|Reported Event|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
229095|NCT01280591|E1|Reported Event|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
229096|NCT01280552|B3|Baseline|Total|Total of all reporting groups
229097|NCT01280552|B2|Baseline|Placebo|"Autologous dendritic cells that have not been pulsed with antigens
Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
229098|NCT01280552|B1|Baseline|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
229099|NCT01280552|P2|Participant Flow|Placebo|"Autologous dendritic cells that have not been pulsed with antigens
Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
229100|NCT01280552|P1|Participant Flow|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
229101|NCT01280552|O2|Outcome|Placebo|"Autologous dendritic cells that have not been pulsed with antigens
Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
229102|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
229103|NCT01280552|O2|Outcome|Control|"Autologous dendritic cells that have not been pulsed with antigens
Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
229104|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
229105|NCT01280552|O2|Outcome|Placebo|"Autologous dendritic cells that have not been pulsed with antigens
Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
229106|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
229107|NCT01280552|O2|Outcome|Control Dendritic Cells|Treatment with autologous dendritic cells not pulsed with immunogenic peptides
229108|NCT01280552|O1|Outcome|ICT-107|Treatment with autologous dendritic cells pulsed with immunogenic peptides
229109|NCT01280552|E2|Reported Event|Placebo|"Autologous dendritic cells that have not been pulsed with antigens
Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
229110|NCT01280552|E1|Reported Event|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
229111|NCT01280357|B1|Baseline|Monitor With the Philips 50XM, Remove Monica AN24|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the predicate Tocco device
229112|NCT01280357|P1|Participant Flow|All Participants|during labor & delivery fetal heart rate, maternal heart rate and uterine contractions were monitored simultaneously by the Monia AN24 & the Philips 50XM
229113|NCT01280357|O1|Outcome|All Participants|all participants that had maternal heart rate measured with the Monica AN24 & the Philips 50XM
229114|NCT01280357|O1|Outcome|All Participants|all participants that had fetal heart rate measured with the Monica AN24 & the Philips 50XM
229115|NCT01280357|O1|Outcome|All Participants|Continue monitoring with the Philips 50XM and disconnect the Monica AN24 monitor.
229116|NCT01280357|E2|Reported Event|Monica AN24|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM
229117|NCT01280357|E1|Reported Event|Philips 50XM,|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM
229118|NCT01280266|B3|Baseline|Total|Total of all reporting groups
229119|NCT01280266|B2|Baseline|Udenafil-Amlodipine (UA) Arm|Udenafil first, then Amlodipine
229120|NCT01280266|B1|Baseline|Amlodipine-Udenafil (AU) Arm|Amlodipine first, then Udenafil
229121|NCT01280266|P2|Participant Flow|Udenafil-Amlodipine (UA) Arm|Udenafil 100mg PO QD for 4 weeks, washout period for 1 week, then Udenafil 10mg PO QD for 4 weeks.
229122|NCT01280266|P1|Participant Flow|Amlodipine-Udenafil (AU) Arm|Amlodipine 10mg PO QD for 4 weeks, washout period for 1week, then Udenafil 100mg PO QD for 4 weeks.
229123|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
229124|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
229125|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
229126|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
229127|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
229128|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
229129|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
229130|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
229131|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
229132|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
229133|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
229134|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
229135|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
229136|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
229137|NCT01280266|O2|Outcome|Udenafil|Changes in RPS during udenafil 10 mg orally per day
229138|NCT01280266|O1|Outcome|Amlodipine|Changes in RPS during amlodipine 100 mg orally per day
229139|NCT01280266|O2|Outcome|Udenafil|Changes in RP attacks per day during udenafil 100mg orally per day
229140|NCT01280266|O1|Outcome|Amlodipine|Changes in RP attacks per day during amlodipine 10 mg orally per day
229141|NCT01280266|E2|Reported Event|Udenafil|Adverse effects observed while taking udenafil in both study arms
229142|NCT01280266|E1|Reported Event|Amlodipine|Adverse effects observed while taking amlodipine in both study arms
229143|NCT01280123|B4|Baseline|Total|Total of all reporting groups
229144|NCT01280123|B3|Baseline|Matching Placebo|"Placebo
placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
229145|NCT01280123|B2|Baseline|45 mg Pioglitazone|"45 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229146|NCT01280123|B1|Baseline|15 mg Pioglitazone|"15 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229147|NCT01280123|P3|Participant Flow|Matching Placebo|"Placebo
placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
229148|NCT01280123|P2|Participant Flow|45 mg Pioglitazone|"45 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229165|NCT01280123|O3|Outcome|Matching Placebo|"Placebo
placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
229149|NCT01280123|P1|Participant Flow|15 mg Pioglitazone|"15 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229150|NCT01280123|O3|Outcome|Matching Placebo|"Placebo
placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
229151|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229152|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229153|NCT01280123|O3|Outcome|Matching Placebo|"Placebo
placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
229154|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229155|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229156|NCT01280123|O3|Outcome|Matching Placebo|"Placebo
placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
229157|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229158|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229159|NCT01280123|O3|Outcome|Matching Placebo|"Placebo
placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
229160|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229161|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229162|NCT01280123|O3|Outcome|Matching Placebo|"Placebo
placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
229163|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229164|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229166|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229167|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229168|NCT01280123|E3|Reported Event|Matching Placebo|"Placebo
placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
229169|NCT01280123|E2|Reported Event|45 mg Pioglitazone|"45 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229170|NCT01280123|E1|Reported Event|15 mg Pioglitazone|"15 mg pioglitazone
Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo
44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
229171|NCT01280110|B3|Baseline|Total|Total of all reporting groups
229172|NCT01280110|B2|Baseline|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
229173|NCT01280110|B1|Baseline|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
229174|NCT01280110|P2|Participant Flow|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
229175|NCT01280110|P1|Participant Flow|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
229176|NCT01280110|O2|Outcome|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
229177|NCT01280110|O1|Outcome|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
229178|NCT01280110|O2|Outcome|Preservative-free Lubricating Drops|he second group will receive preservative-free lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
229179|NCT01280110|O1|Outcome|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
229180|NCT01280110|E2|Reported Event|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
229181|NCT01280110|E1|Reported Event|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
229182|NCT01279564|B3|Baseline|Total|Total of all reporting groups
229183|NCT01279564|B2|Baseline|Control|"Intubation
Endotracheal tube: Intubation"
229184|NCT01279564|B1|Baseline|ETview|"Endotracheal intubation with ETview TVT
ETview TVT endotracheal tube: intubation"
229185|NCT01279564|P2|Participant Flow|Control|"Intubation
Endotracheal tube- standard"
229186|NCT01279564|P1|Participant Flow|ETview|"Endotracheal intubation with ETview TVT
ETview TVT endotracheal tube: intubation"
229187|NCT01279564|O2|Outcome|Control|"Intubation
Duration of intubation"
229188|NCT01279564|O1|Outcome|ETview|"Endotracheal intubation with ETview TVT
Duration of intubation"
229189|NCT01279564|E2|Reported Event|Control|"Intubation
Endotracheal tube: Intubation
No adverse events"
229190|NCT01279564|E1|Reported Event|ETview|"Endotracheal intubation with ETview TVT
ETview TVT endotracheal tube: intubation
No adverse events"
229191|NCT01279447|B3|Baseline|Total|Total of all reporting groups
229192|NCT01279447|B2|Baseline|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
0.25% Bupivacaine: 10cc, single dose, US guided injection"
229193|NCT01279447|B1|Baseline|Placebo|"A sham infrapatellar block performed under US guidance with normal saline
Normal Saline: 10cc, single dose, US guided injection"
229194|NCT01279447|P2|Participant Flow|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
0.25% Bupivacaine: 10cc, single dose, US guided injection"
229195|NCT01279447|P1|Participant Flow|Placebo|"A sham infrapatellar block performed under US guidance with normal saline
Normal Saline: 10cc, single dose, US guided injection"
229196|NCT01279447|O2|Outcome|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
0.25% Bupivacaine: 10cc, single dose, US guided injection"
229197|NCT01279447|O1|Outcome|Placebo|"A sham infrapatellar block performed under US guidance with normal saline
Normal Saline: 10cc, single dose, US guided injection"
229198|NCT01279447|E2|Reported Event|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
0.25% Bupivacaine: 10cc, single dose, US guided injection"
241961|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
229199|NCT01279447|E1|Reported Event|Placebo|"A sham infrapatellar block performed under US guidance with normal saline
Normal Saline: 10cc, single dose, US guided injection"
229200|NCT01279317|B1|Baseline|Vinegar Co-ingestion|All participants performed both intervention periods.
229201|NCT01279317|P2|Participant Flow|Placebo Co-ingestion First, Then Vinegar Co-ingestion|First acute experiment with placebo-coingestion (1 day), after 1 week washout experiment with vinegar co-ingestion (1 day).
229202|NCT01279317|P1|Participant Flow|Vinegar Co-ingestion First, Then Placebo Co-intestion|First acute experiment with vinegar-coingestion (1 day), after 1 week washout, experiment with placebo co-ingestion (1 day).
229203|NCT01279317|O2|Outcome|Placebo Co-ingestion|
229204|NCT01279317|O1|Outcome|Vinegar Co-ingestion|
229205|NCT01279317|E1|Reported Event|Vinegar Co-ingestion|All participants performed both intervention periods.
229206|NCT01279265|B3|Baseline|Total|Total of all reporting groups
229207|NCT01279265|B2|Baseline|Nutramigen A+|"Hypoallergenic formula without lactobacilli
Nutramigen A+: Hypoallergenic formula without lactobacillus"
229208|NCT01279265|B1|Baseline|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
229209|NCT01279265|P2|Participant Flow|Nutramigen A+|"Hypoallergenic formula without lactobacilli
Nutramigen A+: Hypoallergenic formula without lactobacillus"
229210|NCT01279265|P1|Participant Flow|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
229211|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)
Nutramigen A+: Hypoallergenic formula without lactobacillus"
229212|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|"Formula with probiotics (Lactobaccillus Rhamnosus GG)
Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG"
229213|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without lactobacilli
Nutramigen A+: Hypoallergenic formula without lactobacillus"
229214|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
229215|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without lactobacilli
Nutramigen A+: Hypoallergenic formula without lactobacillus"
229216|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
229217|NCT01279265|E2|Reported Event|Nutramigen A+|"Hypoallergenic formula without lactobacilli
Nutramigen A+: Hypoallergenic formula without lactobacillus"
229218|NCT01279265|E1|Reported Event|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
229219|NCT01279200|B3|Baseline|Total|Total of all reporting groups
229220|NCT01279200|B2|Baseline|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.
Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
229221|NCT01279200|B1|Baseline|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).
Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
229222|NCT01279200|P2|Participant Flow|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.
Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
229223|NCT01279200|P1|Participant Flow|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).
Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
229224|NCT01279200|O2|Outcome|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.
Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
229225|NCT01279200|O1|Outcome|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).
Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
229226|NCT01279200|O2|Outcome|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.
Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
229227|NCT01279200|O1|Outcome|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).
Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
229228|NCT01279200|E2|Reported Event|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.
Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
229229|NCT01279200|E1|Reported Event|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).
Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
229230|NCT01279109|B3|Baseline|Total|Total of all reporting groups
229231|NCT01279109|B2|Baseline|Home Visit|"Home visits focused on preventable infant injuries
Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
229232|NCT01279109|B1|Baseline|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
229233|NCT01279109|P2|Participant Flow|Home Visit|"Home visits focused on preventable infant injuries
Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
229234|NCT01279109|P1|Participant Flow|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
229235|NCT01279109|O2|Outcome|Home Visit|"Home visits focused on preventable infant injuries
Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
229236|NCT01279109|O1|Outcome|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
229237|NCT01279109|O2|Outcome|Home Visit|"Home visits focused on preventable infant injuries
Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
229238|NCT01279109|O1|Outcome|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
229239|NCT01279109|E2|Reported Event|Home Visit|"Home visits focused on preventable infant injuries
Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
229240|NCT01279109|E1|Reported Event|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
229241|NCT01279070|B3|Baseline|Total|Total of all reporting groups
229242|NCT01279070|B2|Baseline|Repyflec Training|Cognitive remediation treatment
229243|NCT01279070|B1|Baseline|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
229244|NCT01279070|P2|Participant Flow|Leisure Group (Control Group)|"Leisure group
Parallel to the experimental group, a leisure control group was established which participated in 32 stimulating and socializing activities (e.g., card games, board games, coffee & talk, etc.) over 4 months twice a week and lasting 1 h."
229245|NCT01279070|P1|Participant Flow|Experimental Group (Repyflec Cognitive Remediation)|"Cognitive remediation (CR) group training (Repyflec)
REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations,examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF)."
229246|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
229247|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
229248|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
229249|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
229250|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
229251|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
229252|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
229253|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
229254|NCT01279070|O2|Outcome|Leisure & Socialization Group|"Parallel to the experimental group, a leisure group was established (control group) which participated in 32 stimulating and socializing activities (e.g., card games, board games, coffee & talk, geography review, etc)."
229255|NCT01279070|O1|Outcome|REPYFLEC Cognitive Group Trainining|"REPYFLEC is a strategy-based training, explicitly described from session to session, which is carried out using pencil and paper with a blackboard as visual support. This format allows results to be replicated with rigour. The working content is divided into two principal areas: Problem solving (PS) and Cognitive Flexibility (CF). In the PS block, training in executive function, the thinking process and self-monitoring was emphasized. In the CF block, the tasks require the use of cognitive flexibility for successful completion. Some activities seek to promote training of other functions such as memory, working memory, sustained attention and language. Development of training was performed taking into account the contextual bases of learning, mainly using techniques as modelling to foster coping abilities, molding, self-monitoring, errorless learning and Socratic questioning. REPYFLEC is carried out in a group format (4-6), consisting of 32 sessions lasting 1 hour."
229256|NCT01279070|O2|Outcome|Leisure & Socialization Group|"The leisure group consists in 32 stimulating and socializing group activities (e.g., card games, board games, coffee & talk, geography review, etc.)without specific goals."
229257|NCT01279070|O1|Outcome|REPYFLEC Cognitive Remediation Group Training|REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations, examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF). In the PS module (16 sessions), training in executive function,thinking processes and self-monitoring was emphasized.In the CF module (16 sessions), all the tasks require practice of cognitive flexibility combined with other executive abilities such as planning or self-monitoring.
231837|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
229258|NCT01279070|E2|Reported Event|Repyflec Training|Cognitive remediation group treatment based on Problem Solving and Cognitive Flexibility
229259|NCT01279070|E1|Reported Event|Leisure Group|Stimulating activities without specific goals and focused on leisure
229260|NCT01279044|B4|Baseline|Total|Total of all reporting groups
229261|NCT01279044|B3|Baseline|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
229262|NCT01279044|B2|Baseline|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
229263|NCT01279044|B1|Baseline|Phase 1 - Formative Research|Formative research through individual interviews and pilot testing to develop and adapt the key elements of Personal Cognitive Counseling
229264|NCT01279044|P3|Participant Flow|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
229265|NCT01279044|P2|Participant Flow|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
229266|NCT01279044|P1|Participant Flow|Formative Phase 1|Individual interviews and pilot testing to develop and adapt key elements of Personal Cognitive Counseling
229267|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
229268|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
229269|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
229270|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
229271|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
229272|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
229273|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
229274|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
229275|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
229276|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
229277|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
229278|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
229279|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
229280|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
229281|NCT01279044|E2|Reported Event|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
229282|NCT01279044|E1|Reported Event|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
229283|NCT01278953|B3|Baseline|Total|Total of all reporting groups
229284|NCT01278953|B2|Baseline|Control|"Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
229285|NCT01278953|B1|Baseline|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
241962|NCT01242514|E3|Reported Event|FOSTA 150 MG QD|
229286|NCT01278953|P2|Participant Flow|Control|"Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
229287|NCT01278953|P1|Participant Flow|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
229288|NCT01278953|O2|Outcome|Control|"Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
229289|NCT01278953|O1|Outcome|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
229290|NCT01278953|O2|Outcome|Control|"Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
229291|NCT01278953|O1|Outcome|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
229292|NCT01278953|E2|Reported Event|Control|"Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
229293|NCT01278953|E1|Reported Event|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
229294|NCT01278927|B5|Baseline|Total|Total of all reporting groups
229295|NCT01278927|B4|Baseline|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
229296|NCT01278927|B3|Baseline|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
229297|NCT01278927|B2|Baseline|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
229298|NCT01278927|B1|Baseline|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
229299|NCT01278927|P4|Participant Flow|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
229300|NCT01278927|P3|Participant Flow|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
229301|NCT01278927|P2|Participant Flow|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
229302|NCT01278927|P1|Participant Flow|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
229303|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
229304|NCT01278927|O3|Outcome|Exercise and Stress Management|Exercise and Stress Management - Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
229305|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
229306|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
229307|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
229308|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
229309|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
229310|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
229311|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
229312|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
229313|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
229314|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
229315|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
229316|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
229317|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
229318|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
229319|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
229320|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
229321|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
229322|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
229323|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
229324|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
229325|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
229326|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
229327|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
229328|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
229329|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
229330|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
229331|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
229332|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
229333|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
229334|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
229335|NCT01278927|E4|Reported Event|Standard Care|"Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress).
Standard Care: Patients randomized to standard care only will be informed of their assigned condition and receive the DVD."
229336|NCT01278927|E3|Reported Event|Exercise and Stress Management|"Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.
Exercise and Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions."
229337|NCT01278927|E2|Reported Event|Stress Management|"Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.
Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention."
229338|NCT01278927|E1|Reported Event|Exercise|"Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant.
Exercise: Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention."
229339|NCT01278797|B1|Baseline|Entire Study Population|Includes all subjects randomized to either treatment sequence
229340|NCT01278797|P2|Participant Flow|Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg|Individual components followed by Combination tablet
229341|NCT01278797|P1|Participant Flow|Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg|Combination tablet followed by individual components
229342|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
229343|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
229344|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
229345|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
229346|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
229347|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
229348|NCT01278797|E2|Reported Event|Telm 80 mg + Amlo 10 mg|Individual tablets
229349|NCT01278797|E1|Reported Event|Telm/Amlo 80 mg/10 mg|Combination tablet
229350|NCT01278745|B3|Baseline|Total|Total of all reporting groups
229351|NCT01278745|B2|Baseline|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229352|NCT01278745|B1|Baseline|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229353|NCT01278745|P4|Participant Flow|Discontinued Pre-Randomization|Subjects that were enrolled and transplanted on study, but withdrew from the study prior to randomization.
229354|NCT01278745|P3|Participant Flow|Discontinued Pre-Transplant|Subjects that enrolled, but withdrew from the study prior to their transplant.
229355|NCT01278745|P2|Participant Flow|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229356|NCT01278745|P1|Participant Flow|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229357|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229358|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229405|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229406|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229679|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229359|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229360|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229361|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229362|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229363|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229364|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229365|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229366|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229407|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229880|NCT01276821|B2|Baseline|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
229367|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229368|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229369|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229370|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229371|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229372|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229373|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229374|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229408|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229881|NCT01276821|B1|Baseline|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
229375|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229376|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229377|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229378|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229379|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229380|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229381|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229382|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229383|NCT01278745|E4|Reported Event|Discontinued Pre-Randomization|Subjects that were enrolled and transplanted on study, but withdrew from the study prior to randomization.
229384|NCT01278745|E3|Reported Event|Discontinued Pre-Transplant|Subjects that enrolled, but withdrew from the study prior to their transplant.
229440|NCT01278342|B4|Baseline|Total|Total of all reporting groups
229385|NCT01278745|E2|Reported Event|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229386|NCT01278745|E1|Reported Event|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
229387|NCT01278615|B1|Baseline|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
229388|NCT01278615|P1|Participant Flow|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
229389|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
229390|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
229391|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
229392|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
229393|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
229394|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
229395|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
229396|NCT01278615|E1|Reported Event|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
229397|NCT01278485|B1|Baseline|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229398|NCT01278485|P1|Participant Flow|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229399|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229400|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229401|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229402|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229403|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229404|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229882|NCT01276821|P2|Participant Flow|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
229409|NCT01278485|E1|Reported Event|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
229410|NCT01278407|B4|Baseline|Total|Total of all reporting groups
229411|NCT01278407|B3|Baseline|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
229412|NCT01278407|B2|Baseline|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
229413|NCT01278407|B1|Baseline|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
229414|NCT01278407|P5|Participant Flow|Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
229415|NCT01278407|P4|Participant Flow|Placebo to Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
229416|NCT01278407|P3|Participant Flow|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
229417|NCT01278407|P2|Participant Flow|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
229418|NCT01278407|P1|Participant Flow|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
229419|NCT01278407|O3|Outcome|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
229420|NCT01278407|O2|Outcome|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
229421|NCT01278407|O1|Outcome|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
229422|NCT01278407|O3|Outcome|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
229423|NCT01278407|O2|Outcome|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
229424|NCT01278407|O1|Outcome|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
229425|NCT01278407|E5|Reported Event|Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
229426|NCT01278407|E4|Reported Event|Placebo to Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
229427|NCT01278407|E3|Reported Event|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
229428|NCT01278407|E2|Reported Event|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
229429|NCT01278407|E1|Reported Event|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
229430|NCT01278394|B1|Baseline|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
229431|NCT01278394|P1|Participant Flow|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
229432|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
229433|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
229434|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
229435|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
229436|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
229437|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
229438|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
229439|NCT01278394|E1|Reported Event|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
229441|NCT01278342|B3|Baseline|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:
1st week: 0.25 mg twice a week (0.50 mg/week)
2nd week: 0.50 mg/week twice a week (1 mg/week)
3rd week: 0.50 mg four times a week (2 mg/week)
4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
229442|NCT01278342|B2|Baseline|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
229443|NCT01278342|B1|Baseline|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
229444|NCT01278342|P3|Participant Flow|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:
1st week: 0.25 mg twice a week (0.50 mg/week)
2nd week: 0.50 mg/week twice a week (1 mg/week)
3rd week: 0.50 mg four times a week (2 mg/week)
4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
229445|NCT01278342|P2|Participant Flow|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
229446|NCT01278342|P1|Participant Flow|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
229447|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:
1st week: 0.25 mg twice a week (0.50 mg/week)
2nd week: 0.50 mg/week twice a week (1 mg/week)
3rd week: 0.50 mg four times a week (2 mg/week)
4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
229448|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
229449|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
229450|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:
1st week: 0.25 mg twice a week (0.50 mg/week)
2nd week: 0.50 mg/week twice a week (1 mg/week)
3rd week: 0.50 mg four times a week (2 mg/week)
4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
229451|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
229452|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
229453|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:
1st week: 0.25 mg twice a week (0.50 mg/week)
2nd week: 0.50 mg/week twice a week (1 mg/week)
3rd week: 0.50 mg four times a week (2 mg/week)
4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
229454|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
229455|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
229456|NCT01278342|E3|Reported Event|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:
1st week: 0.25 mg twice a week (0.50 mg/week)
2nd week: 0.50 mg/week twice a week (1 mg/week)
3rd week: 0.50 mg four times a week (2 mg/week)
4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
229457|NCT01278342|E2|Reported Event|Sandostatin LAR High Dose + Pegvisomant|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
229458|NCT01278342|E1|Reported Event|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months
229459|NCT01278303|B1|Baseline|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents
Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
229460|NCT01278303|P1|Participant Flow|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents
Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
229461|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents
Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
229462|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents
Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
229463|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents
Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
229464|NCT01278303|E1|Reported Event|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents
Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
229465|NCT01278173|B1|Baseline|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
229466|NCT01278173|P1|Participant Flow|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
229467|NCT01278173|O1|Outcome|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
229468|NCT01278173|O1|Outcome|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
229469|NCT01278173|E1|Reported Event|Vigabatrin|
229470|NCT01278160|B3|Baseline|Total|Total of all reporting groups
229471|NCT01278160|B2|Baseline|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229472|NCT01278160|B1|Baseline|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229473|NCT01278160|P2|Participant Flow|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229474|NCT01278160|P1|Participant Flow|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229475|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229476|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229477|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229478|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229479|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229883|NCT01276821|P1|Participant Flow|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
229480|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229481|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229482|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229483|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229484|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229485|NCT01278160|E2|Reported Event|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229486|NCT01278160|E1|Reported Event|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
229487|NCT01278030|B3|Baseline|Total|Total of all reporting groups
229488|NCT01278030|B2|Baseline|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
229489|NCT01278030|B1|Baseline|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
229490|NCT01278030|P2|Participant Flow|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
229491|NCT01278030|P1|Participant Flow|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
229492|NCT01278030|O2|Outcome|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
229493|NCT01278030|O1|Outcome|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
229494|NCT01278030|E2|Reported Event|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
229495|NCT01278030|E1|Reported Event|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
229496|NCT01277861|B3|Baseline|Total|Total of all reporting groups
229497|NCT01277861|B2|Baseline|SALINE|SALINE
229498|NCT01277861|B1|Baseline|FENTANYL|FENTANYL
229499|NCT01277861|P2|Participant Flow|SALINE|SALINE
229500|NCT01277861|P1|Participant Flow|FENTANYL|FENTANYL
229501|NCT01277861|O2|Outcome|Saline Pretreatment Group|Saline 10 ml prior to induction of anesthesia.
229502|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
229503|NCT01277861|O2|Outcome|Saline Pretreatment Group|
229504|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|
229505|NCT01277861|O2|Outcome|Saline Pretreatment Group|Saline 10 ml prior to induction of anesthesia.
229506|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
229507|NCT01277861|E2|Reported Event|SALINE|SALINE
229508|NCT01277861|E1|Reported Event|FENTANYL|FENTANYL
229509|NCT01277822|B3|Baseline|Total|Total of all reporting groups
229510|NCT01277822|B2|Baseline|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
229511|NCT01277822|B1|Baseline|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
229512|NCT01277822|P2|Participant Flow|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
229569|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229513|NCT01277822|P1|Participant Flow|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
229514|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
229515|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
229516|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
229517|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
229518|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
229519|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
229520|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
229521|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
229522|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
229523|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
229524|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
229525|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
229526|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
229527|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
229528|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
229529|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
229530|NCT01277822|E2|Reported Event|Amlodipine 10mg|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
229531|NCT01277822|E1|Reported Event|Losartan 100mg/Amlodipine 5mg|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks
229532|NCT01277757|B1|Baseline|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
229533|NCT01277757|P1|Participant Flow|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
229534|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
229535|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
229536|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
229537|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
229538|NCT01277757|E1|Reported Event|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
229539|NCT01277718|B1|Baseline|Entire Study Population|All participants randomized to any treatment.
229540|NCT01277718|P2|Participant Flow|Treatment A First, Then Treatment C, Followed by Treatment B|Treatment A in Period 1: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 2: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water. Treatment B in Period 3: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. There was minimum of a 13-day washout between cobimetinib doses of each period.
229541|NCT01277718|P1|Participant Flow|Treatment A First, Then Treatment B, Followed by Treatment C|Treatment A in Period 1: One 20-mg tablet of cobimetinib administered orally with 240 milliliters (mL) room temperature water after at least an 8-hour fast. Treatment B in Period 2: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 3: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized Food and Drug Administration (FDA) high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water. There was minimum of a 13-day washout between cobimetinib doses of each period.
229542|NCT01277718|O3|Outcome|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
229543|NCT01277718|O2|Outcome|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
229544|NCT01277718|O1|Outcome|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
229545|NCT01277718|O3|Outcome|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
229546|NCT01277718|O2|Outcome|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
229547|NCT01277718|O1|Outcome|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
229548|NCT01277718|E3|Reported Event|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
229549|NCT01277718|E2|Reported Event|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
229550|NCT01277718|E1|Reported Event|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
229551|NCT01277601|B5|Baseline|Total|Total of all reporting groups
229552|NCT01277601|B4|Baseline|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229553|NCT01277601|B3|Baseline|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
229554|NCT01277601|B2|Baseline|TDF 48 Weeks + Peg-IFN 16 Week|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
229555|NCT01277601|B1|Baseline|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229556|NCT01277601|P4|Participant Flow|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229557|NCT01277601|P3|Participant Flow|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
229558|NCT01277601|P2|Participant Flow|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
229559|NCT01277601|P1|Participant Flow|TDF+Peg-IFN 48 Weeks|Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily plus peginterferon α-2a (Peg-IFN) 180 µg subcutaneous (s.c.) injection once weekly for 48 weeks
229560|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229561|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
229562|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229563|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229564|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229565|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
229566|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229567|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
229568|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
241963|NCT01242514|E2|Reported Event|FOSTA 100 MG QD|
229570|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229571|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229572|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
229573|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229574|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
229575|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229576|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229577|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229578|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229579|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
229580|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229581|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
229582|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229583|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229584|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229585|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229586|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
229587|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229588|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
229589|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229590|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229591|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229592|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229593|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
229594|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229595|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
229596|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229597|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229598|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229599|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229600|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
229601|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229602|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
229603|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229604|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229605|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229606|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229607|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
229608|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229609|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
229610|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229611|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229612|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229613|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229614|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
229615|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229616|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
229617|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229618|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229619|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229620|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229621|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
229622|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229623|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
229624|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
229625|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
229626|NCT01277601|O4|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229627|NCT01277601|O3|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
229628|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
229629|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229630|NCT01277601|O4|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229631|NCT01277601|O3|Outcome|TDF 120 Week|TDF 300 mg tablet once daily for 120 weeks
229632|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
229633|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229634|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229635|NCT01277601|O2|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
229636|NCT01277601|O1|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
229637|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229638|NCT01277601|O2|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
229639|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
229640|NCT01277601|E7|Reported Event|Peg-IFN 48 Weeks (Retreated)|"Adverse events in this reporting group are those occurring during the retreatment phase (from start of retreatment up to Week 120 plus 30 days).
TDF 300 mg tablet once daily up to Week 120"
229641|NCT01277601|E6|Reported Event|Peg-IFN 48 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.
Peg-IFN 180 µg s.c. injection once weekly for 48 weeks"
229642|NCT01277601|E5|Reported Event|TDF 120 Weeks|"Adverse events in this reporting group are those occurring during the initial treatment phase (up to 120 weeks plus 30 days).
TDF 300 mg tablet once daily for up to 120 weeks"
229643|NCT01277601|E4|Reported Event|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|"Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.
TDF 300 mg tablet once daily up to Week 120"
229644|NCT01277601|E3|Reported Event|TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks"
229645|NCT01277601|E2|Reported Event|TDF+Peg-IFN 48 Weeks (Retreated)|"Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.
TDF 300 mg tablet once daily up to Week 120"
229646|NCT01277601|E1|Reported Event|TDF+Peg-IFN 48 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.
TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks"
229647|NCT01277549|B3|Baseline|Total|Total of all reporting groups
229648|NCT01277549|B2|Baseline|Nonmobilized Donors|Donors not mobilized prior to MNC collection
229649|NCT01277549|B1|Baseline|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
229650|NCT01277549|P2|Participant Flow|Non-mobilized Donors|In this arm, donors were not mobilized prior to mononuclear cell collection. Only collection efficiency of mononuclear cells could be assessed as CD34+ cells are not present in this population.
229651|NCT01277549|P1|Participant Flow|G-CSF Mobilized Donors|In this arm the donors received G-CSF (granulocyte colony stimulating factor) prior to the MNC (mononuclear cell) collection. G-CSF causes the mobilization of hematopoetic stem cells which are CD34 (cluster of differentiation 34) + to the peripheral blood. Collection efficiency of all mononuclear cells and of the CD34+ subset of mononuclear cells was assessed.
229652|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection.
229653|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
229654|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
229655|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
229656|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
229657|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
229658|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
229659|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
229660|NCT01277549|O2|Outcome|Nonmobilized Donors|Donors were not mobilized prior to MNC collection.
229661|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection.
229662|NCT01277549|E2|Reported Event|Nonmobilized Donors|"Donors not mobilized prior to MNC collection. Note that some Adverse Events (Flu-like symptoms, Muscle Aches, and Bone Pain) apply only to G-CSF mobilized donors. Nonmobilized donors were not assessed for these adverse events as they were not at risk."
229663|NCT01277549|E1|Reported Event|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
229664|NCT01277523|B4|Baseline|Total|Total of all reporting groups
229665|NCT01277523|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229666|NCT01277523|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229667|NCT01277523|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229668|NCT01277523|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229669|NCT01277523|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229670|NCT01277523|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229671|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229672|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229673|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229674|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229675|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229676|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229677|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229678|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229680|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229681|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229682|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229683|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229684|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229685|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229686|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229687|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229688|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229689|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229690|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229691|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229692|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229693|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229694|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229695|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229696|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229697|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229698|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229699|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229700|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229701|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229702|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229703|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229704|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229705|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229706|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229707|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229708|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229709|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229710|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229711|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229712|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229713|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229714|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229715|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229716|NCT01277523|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
241964|NCT01242514|E1|Reported Event|FOSTA 100 MG BID|
229717|NCT01277523|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229718|NCT01277523|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
229719|NCT01277510|B3|Baseline|Total|Total of all reporting groups
229720|NCT01277510|B2|Baseline|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
229721|NCT01277510|B1|Baseline|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
229722|NCT01277510|P2|Participant Flow|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
229723|NCT01277510|P1|Participant Flow|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
229724|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
229725|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
229726|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
229727|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
229728|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
229729|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
229730|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
229731|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
229756|NCT01277302|B1|Baseline|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229732|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
229733|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
229734|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
229735|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
229736|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
229737|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
229738|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
229739|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
229740|NCT01277510|E4|Reported Event|Open-label Phase: Previous Cinacalcet|
229741|NCT01277510|E3|Reported Event|Open-label Phase: Previous Placebo|
229742|NCT01277510|E2|Reported Event|Double-blind Phase: Cinacalcet|
229743|NCT01277510|E1|Reported Event|Double-blind Phase: Placebo|
229744|NCT01277354|B3|Baseline|Total|Total of all reporting groups
229745|NCT01277354|B2|Baseline|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
229746|NCT01277354|B1|Baseline|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
229747|NCT01277354|P2|Participant Flow|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
229748|NCT01277354|P1|Participant Flow|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
229749|NCT01277354|O2|Outcome|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
229750|NCT01277354|O1|Outcome|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
229751|NCT01277354|E2|Reported Event|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
229752|NCT01277354|E1|Reported Event|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
229753|NCT01277302|B4|Baseline|Total|Total of all reporting groups
229754|NCT01277302|B3|Baseline|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229755|NCT01277302|B2|Baseline|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229757|NCT01277302|P3|Participant Flow|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229884|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
229758|NCT01277302|P2|Participant Flow|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229759|NCT01277302|P1|Participant Flow|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229760|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229761|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229762|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229763|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229764|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229765|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229766|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229767|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229768|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229769|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229770|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229771|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229772|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229788|NCT01277211|B3|Baseline|Total|Total of all reporting groups
229789|NCT01277211|B2|Baseline|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
229773|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229774|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229775|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229776|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229777|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229778|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229779|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229780|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229781|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229782|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229783|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229784|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229785|NCT01277302|E3|Reported Event|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229786|NCT01277302|E2|Reported Event|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
229787|NCT01277302|E1|Reported Event|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
229790|NCT01277211|B1|Baseline|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
229791|NCT01277211|P2|Participant Flow|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
229792|NCT01277211|P1|Participant Flow|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
229793|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
229794|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
229795|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
229796|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
229797|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
229798|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
229799|NCT01277211|E2|Reported Event|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
229800|NCT01277211|E1|Reported Event|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
229801|NCT01277159|B6|Baseline|Total|Total of all reporting groups
229802|NCT01277159|B5|Baseline|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
IV saline."
229803|NCT01277159|B4|Baseline|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
229804|NCT01277159|B3|Baseline|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
229805|NCT01277159|B2|Baseline|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
229806|NCT01277159|B1|Baseline|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).
A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
229807|NCT01277159|P5|Participant Flow|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
IV saline."
229808|NCT01277159|P4|Participant Flow|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
229809|NCT01277159|P3|Participant Flow|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
229810|NCT01277159|P2|Participant Flow|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
229811|NCT01277159|P1|Participant Flow|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).
A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
229812|NCT01277159|O5|Outcome|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
IV saline."
229813|NCT01277159|O4|Outcome|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
229814|NCT01277159|O3|Outcome|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
229815|NCT01277159|O2|Outcome|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
229816|NCT01277159|O1|Outcome|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).
A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
229817|NCT01277159|E5|Reported Event|Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine|"Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
IV saline."
229818|NCT01277159|E4|Reported Event|Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone (|"Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg)."
229819|NCT01277159|E3|Reported Event|Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp|"Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)"
229820|NCT01277159|E2|Reported Event|Nerve Block With Dexamethasone (4 mg). IV Saline.|"B. Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline."
229821|NCT01277159|E1|Reported Event|Control Nerve Block. IV Dexamethasone (4 mg).|"Control Nerve Block. IV Dexamethasone (4 mg).
A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg)."
229822|NCT01277081|B3|Baseline|Total|Total of all reporting groups
229823|NCT01277081|B2|Baseline|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
229824|NCT01277081|B1|Baseline|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
229825|NCT01277081|P2|Participant Flow|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
229826|NCT01277081|P1|Participant Flow|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 milligram (mg) of paracetamol in 200 milliliter (mL) of boiled mineral water was taken orally by participants within a time period of 15 minutes.
229827|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
229828|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
229829|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
229830|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
229831|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
229832|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
229833|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
229834|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
229835|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
229836|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
229837|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
229838|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
229839|NCT01277081|E2|Reported Event|Paracetamol Tablets|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
229840|NCT01277081|E1|Reported Event|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
229841|NCT01277042|B3|Baseline|Total|Total of all reporting groups
229842|NCT01277042|B2|Baseline|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229843|NCT01277042|B1|Baseline|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229844|NCT01277042|P2|Participant Flow|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229845|NCT01277042|P1|Participant Flow|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229846|NCT01277042|O2|Outcome|Engerix-B Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229847|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229848|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229849|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229850|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229851|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229852|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229853|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229854|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229855|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229856|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229857|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229858|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229859|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229860|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229861|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229862|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229863|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229864|NCT01277042|E2|Reported Event|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229865|NCT01277042|E1|Reported Event|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
229866|NCT01276847|B4|Baseline|Total|Total of all reporting groups
229867|NCT01276847|B3|Baseline|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
229868|NCT01276847|B2|Baseline|No Treatment|No treatment administered
229869|NCT01276847|B1|Baseline|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
229870|NCT01276847|P3|Participant Flow|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
229871|NCT01276847|P2|Participant Flow|No Treatment|No treatment administered
229872|NCT01276847|P1|Participant Flow|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
229873|NCT01276847|O1|Outcome|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
229874|NCT01276847|O1|Outcome|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
229875|NCT01276847|O1|Outcome|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
229876|NCT01276847|E3|Reported Event|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
229877|NCT01276847|E2|Reported Event|No Treatment|No treatment administered
229878|NCT01276847|E1|Reported Event|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
229885|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
229886|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
229887|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
229888|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
229889|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
229890|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
229891|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
229892|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
229893|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
229894|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
229895|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
229896|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
229897|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
229898|NCT01276821|E2|Reported Event|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
229899|NCT01276821|E1|Reported Event|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
229900|NCT01276756|B3|Baseline|Total|Total of all reporting groups
229901|NCT01276756|B2|Baseline|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229902|NCT01276756|B1|Baseline|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229903|NCT01276756|P2|Participant Flow|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229904|NCT01276756|P1|Participant Flow|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229905|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229906|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229907|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229908|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229909|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229910|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229911|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229912|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229913|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229914|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
241965|NCT01242371|B3|Baseline|Total|Total of all reporting groups
229915|NCT01276756|E2|Reported Event|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229916|NCT01276756|E1|Reported Event|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
229917|NCT01276639|B4|Baseline|Total|Total of all reporting groups
229918|NCT01276639|B3|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
229919|NCT01276639|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229920|NCT01276639|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229921|NCT01276639|P5|Participant Flow|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229922|NCT01276639|P4|Participant Flow|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229923|NCT01276639|P3|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
229924|NCT01276639|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229925|NCT01276639|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.
229926|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229927|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229928|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229929|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229930|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
229931|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229932|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229933|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
229934|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229935|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229936|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
229937|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229938|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229939|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
229940|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229941|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229942|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
229943|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229944|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229945|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
229946|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229947|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229948|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229949|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229950|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229951|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229952|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229953|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229954|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229955|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229956|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229957|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229958|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229959|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229960|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229961|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229962|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229963|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229964|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229965|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229966|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229967|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229968|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229969|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229970|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229971|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229972|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229973|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229974|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229975|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229976|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229977|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229978|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229979|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229980|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229981|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229982|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229983|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229984|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229985|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229986|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229987|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229988|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229989|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229990|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229991|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229992|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229993|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229994|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229995|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
229996|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
229997|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
229998|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
229999|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230043|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230000|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230001|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230002|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230003|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230004|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230005|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230006|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230007|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230008|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230009|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230010|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230011|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230012|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230013|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230014|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230015|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230016|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230017|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230018|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230019|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230020|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230021|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230022|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230023|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230024|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230025|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230026|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230027|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230028|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230029|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230030|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230031|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230032|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230033|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230034|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230035|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230036|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230037|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230038|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230039|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230040|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230041|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230042|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
242782|NCT01240785|P2|Participant Flow|Insulin|
230044|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230045|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230046|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230047|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230048|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230049|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230050|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230051|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230052|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230053|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230054|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230055|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230056|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230057|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230058|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230059|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230060|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230061|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230062|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230063|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230064|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230065|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230066|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230067|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230068|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230069|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230070|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230071|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230072|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230073|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230074|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230075|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230076|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230077|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230078|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230079|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230080|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230081|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230082|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230083|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230084|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230085|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
230086|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
230087|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230088|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230090|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230091|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230092|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230093|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230094|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230095|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230096|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230097|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230098|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230099|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230100|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230101|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230102|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230103|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230104|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230105|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230106|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230107|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230108|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230109|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230110|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230111|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
230112|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230113|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230114|NCT01276639|E5|Reported Event|Placebo|Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
230115|NCT01276639|E4|Reported Event|Placebo, CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.
230116|NCT01276639|E3|Reported Event|Placebo, CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.
230117|NCT01276639|E2|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
230118|NCT01276639|E1|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
230119|NCT01276535|B1|Baseline|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.
The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
230120|NCT01276535|P1|Participant Flow|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.
The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
230121|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.
The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
230122|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.
The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
230123|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.
The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
230180|NCT01276509|E3|Reported Event|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230181|NCT01276509|E2|Reported Event|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230124|NCT01276535|E1|Reported Event|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.
The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
230125|NCT01276509|B5|Baseline|Total|Total of all reporting groups
230126|NCT01276509|B4|Baseline|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
230127|NCT01276509|B3|Baseline|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230128|NCT01276509|B2|Baseline|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230129|NCT01276509|B1|Baseline|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230130|NCT01276509|P4|Participant Flow|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
230131|NCT01276509|P3|Participant Flow|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230132|NCT01276509|P2|Participant Flow|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230133|NCT01276509|P1|Participant Flow|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230134|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230135|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230136|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230137|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230138|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230139|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230140|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230141|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230142|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230143|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230144|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230145|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230146|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230147|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230148|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230149|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230150|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230151|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230152|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230153|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230154|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230155|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
230156|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230157|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230158|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230159|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
230160|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230161|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230162|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230163|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
230164|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230165|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230166|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230167|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
230168|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230169|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230170|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230171|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
230172|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230173|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230174|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230175|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
230176|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
230177|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
230178|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230182|NCT01276509|E1|Reported Event|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
230183|NCT01276457|B3|Baseline|Total|Total of all reporting groups
230184|NCT01276457|B2|Baseline|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230185|NCT01276457|B1|Baseline|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230186|NCT01276457|P2|Participant Flow|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230187|NCT01276457|P1|Participant Flow|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230188|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230189|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230190|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230191|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230192|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230193|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230194|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230195|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
242783|NCT01240785|P1|Participant Flow|Metformin Arm|
230196|NCT01276457|E2|Reported Event|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230197|NCT01276457|E1|Reported Event|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
230198|NCT01276353|B3|Baseline|Total|Total of all reporting groups
230199|NCT01276353|B2|Baseline|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
230200|NCT01276353|B1|Baseline|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
230201|NCT01276353|P2|Participant Flow|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
230202|NCT01276353|P1|Participant Flow|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
230203|NCT01276353|O2|Outcome|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
230204|NCT01276353|O1|Outcome|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once in the morning daily for 52 weeks in the extension phase.
230205|NCT01276353|O2|Outcome|E2020 10 mg (EM)|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
230206|NCT01276353|O1|Outcome|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
230207|NCT01276353|E4|Reported Event|E2020 10 mg (Extension)|E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
230208|NCT01276353|E3|Reported Event|E2020 SR 23 mg (Extension)|E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
230209|NCT01276353|E2|Reported Event|E2020 10 mg (Double-blind)|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
230210|NCT01276353|E1|Reported Event|E2020 SR 23 mg (Double-blind)|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
230211|NCT01276327|B3|Baseline|Total|Total of all reporting groups
230212|NCT01276327|B2|Baseline|Sequence RTRT|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.
230213|NCT01276327|B1|Baseline|Sequence TRTR|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.
230214|NCT01276327|P2|Participant Flow|Sequence RTRT|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.
230215|NCT01276327|P1|Participant Flow|Sequence TRTR|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.
230216|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
230217|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
230218|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
230219|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
230220|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
230221|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
230222|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
230223|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
230224|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
230225|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
230226|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
230227|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
230228|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
230229|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
230230|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
230231|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
230232|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
230233|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
230234|NCT01276327|E2|Reported Event|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
230235|NCT01276327|E1|Reported Event|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
230236|NCT01276301|B1|Baseline|Entire Study Population|"An open label, randomised, two-period crossover trial. The two treatments administered were
A single dose of empagliflozin (empa) 25 mg
A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil
The two treatment periods were separated by a washout period of at least 7 days."
230237|NCT01276301|P2|Participant Flow|Empa Plus Verapamil / Empa|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg.
230238|NCT01276301|P1|Participant Flow|Empa / Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230239|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230240|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
230241|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230242|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
230243|NCT01276301|O1|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230244|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230245|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
230246|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230247|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
230248|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230249|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
230250|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230251|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
230252|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230253|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
230254|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230255|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
230256|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230257|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
230258|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230259|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
230260|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230261|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
230262|NCT01276301|E2|Reported Event|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
230263|NCT01276301|E1|Reported Event|Empa|A single dose of empagliflozin (empa) 25 mg.
230264|NCT01276288|B1|Baseline|Overall Patients|A randomised, open-label, multiple-dose, 2- way cross-over study. All patients received 25 mg empagliflozin in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h) (days 1 to 5). Following a wash-out period of seven days, half of the patients received 25 mg hydrochlorothiazide (HCT) either on its own in a form of a film-coated tablet orally once daily (days 1 to 4) or in combination with 25 mg empagliflozin ( days 5 to 9), while the other half of the patients received 5 mg torasemide (TOR) either on its own (days 1 to 4) or in combination with the 25 mg empagliflozin ( days 5 to 9). This sequence was then reversed so that the HCT or TOR and its combination with 25 mg empagliflozin were administered first in a same manner as stated above, followed by 25 mg empagliflozin after seven days wash out period.
230265|NCT01276288|P4|Participant Flow|Empa+TOR/ Empa|Patients received 5mg torasemide (TOR) in combination with 25mg Empa. Following a wash-out period of seven days, 25 mg Empa was administered in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h).
230312|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230266|NCT01276288|P3|Participant Flow|Empa/ Empa+ TOR|Patients received 25mg Empa in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h). Following a wash-out period of seven days, 5 mg torasemide (TOR) in combination with 25mg Empa was administered.
230267|NCT01276288|P2|Participant Flow|Empa+HCT/ Empa|Patients received 25mg hydrochlorothiazide (HCT) in a form of a film-coated tablet orally once daily in combination with 25mg Empa. Following a wash-out period of seven days 25 mg Empa was administered in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h).
230268|NCT01276288|P1|Participant Flow|Empa / Empa+HCT|Patients received 25mg empagliflozin (Empa) orally in a form of a film-coated tablet once daily following an overnight fast of at least 10 hours (h). Following a wash-out period of seven days, 25mg hydrochlorothiazide (HCT) in a form of a film-coated tablet was administered orally once daily in combination with 25mg Empa.
230269|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230270|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230271|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230272|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230273|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230274|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230275|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230276|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230277|NCT01276288|O6|Outcome|TOR-M3 + Empa|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
230278|NCT01276288|O5|Outcome|TOR-M1+ Empa|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
230279|NCT01276288|O4|Outcome|TOR Metabolite (TOR-M3)|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism.
230280|NCT01276288|O3|Outcome|TOR Metabolite (TOR-M1)|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism.
230281|NCT01276288|O2|Outcome|TOR+ Empa|Torasemide (TOR) 5 mg and Empagliflozin (Empa) 25 mg administered once daily for 5 days
230282|NCT01276288|O1|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230283|NCT01276288|O6|Outcome|TOR-M3 + Empa|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
230284|NCT01276288|O5|Outcome|TOR-M1+ Empa|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
230285|NCT01276288|O4|Outcome|TOR Metabolite (TOR-M3)|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism.
230286|NCT01276288|O3|Outcome|TOR Metabolite (TOR-M1)|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism.
230287|NCT01276288|O2|Outcome|TOR+ Empa|Torasemide (TOR) 5 mg and Empagliflozin (Empa) 25 mg administered once daily for 5 days
230288|NCT01276288|O1|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230289|NCT01276288|O2|Outcome|HCT+ Empa|Hydrochlorothiazide (HCT) 25 mg followed by Empagliflozin (Empa) 25 mg administered once daily for 5 days
230290|NCT01276288|O1|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230291|NCT01276288|O2|Outcome|HCT+ Empa|Hydrochlorothiazide (HCT) 25 mg followed by Empagliflozin (Empa) 25 mg administered once daily for 5 days
230292|NCT01276288|O1|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230293|NCT01276288|O3|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230294|NCT01276288|O2|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230295|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230296|NCT01276288|O3|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230297|NCT01276288|O2|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230298|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230299|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230300|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230301|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230302|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230303|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230304|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230305|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230306|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230307|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230308|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230309|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230310|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230311|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230313|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230314|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230315|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230316|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230317|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230318|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230319|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230320|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230321|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230322|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230323|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230324|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230325|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230326|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230327|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230328|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230329|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230330|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230331|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230332|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230333|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230334|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230335|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230336|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230337|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230338|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230339|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230340|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230341|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230342|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230343|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230344|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230345|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230346|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230347|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230348|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230349|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230350|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230351|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230352|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230353|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230354|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230355|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230356|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230357|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230358|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230359|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230360|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230361|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230362|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230363|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230364|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230365|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230366|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230367|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230368|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230369|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230370|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230371|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230372|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230373|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230374|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230375|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230376|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230377|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230378|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230379|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230380|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230381|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230382|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230383|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230384|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230385|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230386|NCT01276288|E5|Reported Event|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
230387|NCT01276288|E4|Reported Event|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
230388|NCT01276288|E3|Reported Event|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
230389|NCT01276288|E2|Reported Event|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
230390|NCT01276288|E1|Reported Event|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
230391|NCT01276223|B4|Baseline|Total|Total of all reporting groups
230392|NCT01276223|B3|Baseline|Vehicle|Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
230393|NCT01276223|B2|Baseline|Durezol|Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
230394|NCT01276223|B1|Baseline|Run-In Only|Difluprednate vehicle
230395|NCT01276223|P3|Participant Flow|Vehicle|Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
230396|NCT01276223|P2|Participant Flow|Durezol|Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
230397|NCT01276223|P1|Participant Flow|Run-In Only|Difluprednate vehicle
230398|NCT01276223|O2|Outcome|Vehicle|Difluprednate vehicle
230399|NCT01276223|O1|Outcome|Durezol|Difluprednate 0.5% ophthalmic emulsion
230400|NCT01276223|E3|Reported Event|Vehicle|Difluprednate vehicle
230401|NCT01276223|E2|Reported Event|Durezol|Difluprednate 0.05% ophthalmic emulsion
230402|NCT01276223|E1|Reported Event|Run-In|Difluprednate vehicle, all patients
230403|NCT01276197|B3|Baseline|Total|Total of all reporting groups
230404|NCT01276197|B2|Baseline|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component."
230405|NCT01276197|B1|Baseline|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components
Story-Telling DVD: DVD will contain both informational and story-telling components."
230406|NCT01276197|P2|Participant Flow|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component."
230407|NCT01276197|P1|Participant Flow|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components
Story-Telling DVD: DVD will contain both informational and story-telling components."
230408|NCT01276197|O2|Outcome|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component."
230409|NCT01276197|O1|Outcome|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components
Story-Telling DVD: DVD will contain both informational and story-telling components."
230410|NCT01276197|O2|Outcome|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component."
230411|NCT01276197|O1|Outcome|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components
Story-Telling DVD: DVD will contain both informational and story-telling components."
230412|NCT01276197|E2|Reported Event|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component."
230413|NCT01276197|E1|Reported Event|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components
Story-Telling DVD: DVD will contain both informational and story-telling components."
230414|NCT01276171|B4|Baseline|Total|Total of all reporting groups
230415|NCT01276171|B3|Baseline|Palpation|"Participants will place arterial line using palpation technique
Palpation: Participants will place arterial line using Palpation technique"
230416|NCT01276171|B2|Baseline|Doppler|"Participants will place arterial line using doppler technique
Doppler: Participants will place arterial line using doppler technique"
230417|NCT01276171|B1|Baseline|Ultrasound|"Participants will place arterial line using ultrasound technique
Ultrasound: Participants will place arterial line using ultrasound technique"
230418|NCT01276171|P3|Participant Flow|Palpation|"Participants will place arterial line using palpation technique
Palpation: Participants will place arterial line using Palpation technique"
230419|NCT01276171|P2|Participant Flow|Doppler|"Participants will place arterial line using doppler technique
Doppler: Participants will place arterial line using doppler technique"
230420|NCT01276171|P1|Participant Flow|Ultrasound|"Participants will place arterial line using ultrasound technique
Ultrasound: Participants will place arterial line using ultrasound technique"
230421|NCT01276171|O3|Outcome|Palpation|"Participants will place arterial line using palpation technique
Palpation: Participants will place arterial line using Palpation technique"
230422|NCT01276171|O2|Outcome|Doppler|"Participants will place arterial line using doppler technique
Doppler: Participants will place arterial line using doppler technique"
230423|NCT01276171|O1|Outcome|Ultrasound|"Participants will place arterial line using ultrasound technique
Ultrasound: Participants will place arterial line using ultrasound technique"
230424|NCT01276171|O3|Outcome|Palpation|"Participants will place arterial line using palpation technique
Palpation: Participants will place arterial line using Palpation technique"
230425|NCT01276171|O2|Outcome|Doppler|"Participants will place arterial line using doppler technique
Doppler: Participants will place arterial line using doppler technique"
230426|NCT01276171|O1|Outcome|Ultrasound|"Participants will place arterial line using ultrasound technique
Ultrasound: Participants will place arterial line using ultrasound technique"
230427|NCT01276171|O3|Outcome|Palpation|"Participants will place arterial line using palpation technique
Palpation: Participants will place arterial line using Palpation technique"
230428|NCT01276171|O2|Outcome|Doppler|"Participants will place arterial line using doppler technique
Doppler: Participants will place arterial line using doppler technique"
230429|NCT01276171|O1|Outcome|Ultrasound|"Participants will place arterial line using ultrasound technique
Ultrasound: Participants will place arterial line using ultrasound technique"
230430|NCT01276171|E3|Reported Event|Palpation|"Participants will place arterial line using palpation technique
Palpation: Participants will place arterial line using Palpation technique"
230431|NCT01276171|E2|Reported Event|Doppler|"Participants will place arterial line using doppler technique
Doppler: Participants will place arterial line using doppler technique"
230432|NCT01276171|E1|Reported Event|Ultrasound|"Participants will place arterial line using ultrasound technique
Ultrasound: Participants will place arterial line using ultrasound technique"
230433|NCT01276106|B5|Baseline|Total|Total of all reporting groups
230434|NCT01276106|B4|Baseline|Placebo|Placebo: Capsule, BID
230435|NCT01276106|B3|Baseline|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
230436|NCT01276106|B2|Baseline|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
230437|NCT01276106|B1|Baseline|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
230438|NCT01276106|P4|Participant Flow|Placebo|Placebo: Capsule, BID
230439|NCT01276106|P3|Participant Flow|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
230440|NCT01276106|P2|Participant Flow|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
230441|NCT01276106|P1|Participant Flow|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
230442|NCT01276106|O4|Outcome|Placebo|Placebo: Capsule, BID
230443|NCT01276106|O3|Outcome|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
230444|NCT01276106|O2|Outcome|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
230445|NCT01276106|O1|Outcome|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
230446|NCT01276106|E4|Reported Event|Placebo|Placebo: Capsule, BID
230447|NCT01276106|E3|Reported Event|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
230448|NCT01276106|E2|Reported Event|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
230449|NCT01276106|E1|Reported Event|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
230450|NCT01276054|B3|Baseline|Total|Total of all reporting groups
230451|NCT01276054|B2|Baseline|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies"
230452|NCT01276054|B1|Baseline|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
lymphedema management: Undergo axillary reverse mapping"
230453|NCT01276054|P2|Participant Flow|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies"
230454|NCT01276054|P1|Participant Flow|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
lymphedema management: Undergo axillary reverse mapping"
230479|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230693|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230455|NCT01276054|O2|Outcome|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies"
230456|NCT01276054|O1|Outcome|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
lymphedema management: Undergo axillary reverse mapping"
230457|NCT01276054|E2|Reported Event|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies"
230458|NCT01276054|E1|Reported Event|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
lymphedema management: Undergo axillary reverse mapping"
230459|NCT01275833|B3|Baseline|Total|Total of all reporting groups
230460|NCT01275833|B2|Baseline|Device Programming Allows Intrinsic AV Timing.|VVI-40-RV
230461|NCT01275833|B1|Baseline|Device Programming Modifies AV Timing|"DDD-40-BiV
Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing"
230462|NCT01275833|P2|Participant Flow|Device Programming That Allows Intrinsic AV Timing.|Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
230463|NCT01275833|P1|Participant Flow|Device Programming That Modifies AV Timing|Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing
230464|NCT01275833|O2|Outcome|Device Programming That Allows Intrinsic AV Timing.|Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
230465|NCT01275833|O1|Outcome|Device Programming That Modifies AV Timing|Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing
230466|NCT01275833|E2|Reported Event|Device Programming That Allows Intrinsic AV Timing.|Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing
230467|NCT01275833|E1|Reported Event|Device Programming That Modifies AV Timing|Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing
230468|NCT01275755|B3|Baseline|Total|Total of all reporting groups
230469|NCT01275755|B2|Baseline|ADL5945 0.25mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
230470|NCT01275755|B1|Baseline|Placebo|Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
230471|NCT01275755|P2|Participant Flow|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
230472|NCT01275755|P1|Participant Flow|Placebo|Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
230473|NCT01275755|O2|Outcome|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
230474|NCT01275755|O1|Outcome|Placebo|Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
230475|NCT01275755|E2|Reported Event|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
230476|NCT01275755|E1|Reported Event|Placebo|Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
230477|NCT01275625|B1|Baseline|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230478|NCT01275625|P1|Participant Flow|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230762|NCT01273857|B1|Baseline|Control|"Subjects will undergo standard staged-procedures without cell infusion
staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
230480|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230481|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230482|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230483|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230484|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230485|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230486|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230487|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230488|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230489|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230490|NCT01275625|E1|Reported Event|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
230491|NCT01275586|B1|Baseline|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
230492|NCT01275586|P1|Participant Flow|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
230493|NCT01275586|O1|Outcome|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
230494|NCT01275586|E1|Reported Event|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
230495|NCT01275430|B1|Baseline|Sherlock 3CG|"Sherlock 3CG is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.
Randomization did not occur due to early termination. All participants were assigned to Sherlock 3CG in phase I. Randomization would have occurred at the start of Phase II, but Phase II was not initiated due to early termination."
230496|NCT01275430|P1|Participant Flow|Sherlock 3CG|"Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System.
All participants were assigned to Sherlock 3CG in Phase I. Zero subjects started Phase II because of early termination of the study, so zero subjects were randomized. All adverse event reporting is also for Phase I (3CG) participants."
230497|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
230498|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
230499|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
230500|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
230501|NCT01275430|O1|Outcome|Sherlock 3CG|Mean distance (mm) from the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave amplitude when using Sherlock 3CG.
230502|NCT01275430|E1|Reported Event|Sherlock 3CG|"Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."
230503|NCT01275313|B3|Baseline|Total|Total of all reporting groups
230504|NCT01275313|B2|Baseline|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair
Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
230505|NCT01275313|B1|Baseline|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training
Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
230506|NCT01275313|P2|Participant Flow|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair
Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
230507|NCT01275313|P1|Participant Flow|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training
Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
230918|NCT01273038|B3|Baseline|Total|Total of all reporting groups
230508|NCT01275313|O2|Outcome|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair
Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
230509|NCT01275313|O1|Outcome|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training
Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
230510|NCT01275313|E2|Reported Event|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair
Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
230511|NCT01275313|E1|Reported Event|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training
Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
230512|NCT01275196|B3|Baseline|Total|Total of all reporting groups
230513|NCT01275196|B2|Baseline|Nilotinib|Patients received 300 mg bid (600 mg/day)
230514|NCT01275196|B1|Baseline|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230515|NCT01275196|P2|Participant Flow|Nilotinib|Patients received 300 mg bid (600 mg/day)
230516|NCT01275196|P1|Participant Flow|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230517|NCT01275196|O3|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230518|NCT01275196|O2|Outcome|CGP74588|Major metabolite of Imatinib
230519|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230520|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230521|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230522|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230523|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230524|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230525|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230526|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230527|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230528|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230529|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230530|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230531|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230532|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230533|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230534|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230535|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230536|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230537|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230538|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230539|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230540|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230541|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230542|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230543|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230544|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230545|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230546|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230547|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230548|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230549|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230550|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
230551|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230552|NCT01275196|E2|Reported Event|Nilotinib 300 mg Bid|Patients received 300 mg bid (600 mg/day)
230553|NCT01275196|E1|Reported Event|Imatinib 400 mg qd|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
230554|NCT01275131|B5|Baseline|Total|Total of all reporting groups
230555|NCT01275131|B4|Baseline|Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the euglycemic clamp .
After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to a 6-hr euglycemic clamp."
230568|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230919|NCT01273038|B2|Baseline|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
230556|NCT01275131|B3|Baseline|Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to a 6-hr euglycemic clamp."
230557|NCT01275131|B2|Baseline|Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.
After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
230558|NCT01275131|B1|Baseline|Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.
After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
230559|NCT01275131|P4|Participant Flow|Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp .
After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp."
230560|NCT01275131|P3|Participant Flow|Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp."
230561|NCT01275131|P2|Participant Flow|Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.
After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
230562|NCT01275131|P1|Participant Flow|Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.
After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5-micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
230563|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230564|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230565|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230566|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6 hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230567|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230613|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
230569|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230570|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230571|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230572|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230573|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230574|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230575|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230576|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6 hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230577|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days, including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 or Days 6 and 8.
230578|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230579|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230580|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230581|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230582|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230583|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230584|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230614|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
230615|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
230585|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230586|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230587|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230588|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Day 6 and 8 of Period 2.
230589|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
230590|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
230591|NCT01275131|E4|Reported Event|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230592|NCT01275131|E3|Reported Event|Stage 3: Insulin Aspart|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3 and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
230593|NCT01275131|E2|Reported Event|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230594|NCT01275131|E1|Reported Event|Stage 1: Insulin Aspart|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
230595|NCT01275092|B1|Baseline|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
230596|NCT01275092|P1|Participant Flow|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
230597|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
230598|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
230599|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
230600|NCT01275092|E1|Reported Event|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
230601|NCT01275066|B4|Baseline|Total|Total of all reporting groups
230602|NCT01275066|B3|Baseline|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
230603|NCT01275066|B2|Baseline|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
230604|NCT01275066|B1|Baseline|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
230605|NCT01275066|P3|Participant Flow|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
230606|NCT01275066|P2|Participant Flow|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
230607|NCT01275066|P1|Participant Flow|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
230608|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
230609|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
230610|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
230611|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
230612|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
230616|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
230617|NCT01275066|E3|Reported Event|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
230618|NCT01275066|E2|Reported Event|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
230619|NCT01275066|E1|Reported Event|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
230620|NCT01275053|B1|Baseline|Leptin|leptin: 0.01mg/kg
230621|NCT01275053|P1|Participant Flow|Leptin|leptin: 0.01mg/kg
230622|NCT01275053|O1|Outcome|Leptin|leptin: 0.01mg/kg
230623|NCT01275053|E1|Reported Event|Leptin|leptin: 0.01mg/kg
230624|NCT01274897|B3|Baseline|Total|Total of all reporting groups
230625|NCT01274897|B2|Baseline|Placebo|Subjects received the saline placebo.
230626|NCT01274897|B1|Baseline|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
230627|NCT01274897|P2|Participant Flow|Placebo|Subjects received the saline placebo.
230628|NCT01274897|P1|Participant Flow|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
230629|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
230630|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
230631|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
230632|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
230633|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
230634|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
230635|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
230636|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
230637|NCT01274897|E2|Reported Event|Placebo|Subjects received the saline placebo.
230638|NCT01274897|E1|Reported Event|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
230639|NCT01274715|B1|Baseline|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
230640|NCT01274715|P1|Participant Flow|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
230641|NCT01274715|O1|Outcome|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
230642|NCT01274715|O1|Outcome|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
230643|NCT01274715|E1|Reported Event|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
230644|NCT01274637|B3|Baseline|Total|Total of all reporting groups
230645|NCT01274637|B2|Baseline|Control Group|No treatment control group.
230646|NCT01274637|B1|Baseline|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.
Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
230647|NCT01274637|P2|Participant Flow|Control Group|No treatment control group.
230648|NCT01274637|P1|Participant Flow|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.
Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
230649|NCT01274637|O2|Outcome|Control Group|No treatment control group.
230650|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.
Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
230651|NCT01274637|O2|Outcome|Control Group|No treatment control group.
230652|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.
Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
230653|NCT01274637|O2|Outcome|Control Group|No treatment control group.
230654|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.
Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
230655|NCT01274637|O2|Outcome|Control Group|No treatment control group.
230656|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.
Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
230657|NCT01274637|O2|Outcome|Control Group|No treatment control group.
230658|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.
Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
230659|NCT01274637|O2|Outcome|Control Group|No treatment control group.
230660|NCT01274637|O1|Outcome|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.
Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
230661|NCT01274637|E2|Reported Event|Control Group|No treatment control group.
230662|NCT01274637|E1|Reported Event|Low Molecular Weight Heparin|"Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.
Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes."
230663|NCT01274611|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment.
Botox wase injected into one underarm, targeting the sweat glands, to stop underarm sweating.
For Suction-Curettage, the doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating."
230664|NCT01274611|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment.
Botox was injected into one underarm, targeting the sweat glands, to stop underarm sweating.
For Suction-Curettage, the doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating."
230665|NCT01274611|O2|Outcome|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
230666|NCT01274611|O1|Outcome|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
230667|NCT01274611|O2|Outcome|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
230668|NCT01274611|O1|Outcome|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
230669|NCT01274611|E2|Reported Event|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
230670|NCT01274611|E1|Reported Event|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
230671|NCT01274585|B3|Baseline|Total|Total of all reporting groups
230672|NCT01274585|B2|Baseline|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
230673|NCT01274585|B1|Baseline|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
230674|NCT01274585|P2|Participant Flow|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
230675|NCT01274585|P1|Participant Flow|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
230676|NCT01274585|O2|Outcome|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
230677|NCT01274585|O1|Outcome|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
230678|NCT01274585|E2|Reported Event|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
230679|NCT01274585|E1|Reported Event|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
230680|NCT01274559|B3|Baseline|Total|Total of all reporting groups
230681|NCT01274559|B2|Baseline|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230682|NCT01274559|B1|Baseline|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230683|NCT01274559|P2|Participant Flow|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230684|NCT01274559|P1|Participant Flow|Extended-release Niacin/Laropiprant|Extended-release niacin (ERN)/laropiprant (LRPT) 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230685|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230686|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230687|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230688|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230689|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230690|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230691|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230692|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230694|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230695|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230696|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230697|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230698|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230699|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230700|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230701|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230702|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230703|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230704|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230705|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230706|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230707|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230708|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230709|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230710|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230711|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230712|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230713|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230714|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230715|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230716|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230717|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230718|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230719|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230720|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230721|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230722|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230723|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230724|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230725|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230726|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230727|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230728|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230729|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230730|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
230731|NCT01274559|E2|Reported Event|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
230732|NCT01274559|E1|Reported Event|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
233389|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
230733|NCT01274533|B1|Baseline|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.
Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
230734|NCT01274533|P1|Participant Flow|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.
Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
230735|NCT01274533|O1|Outcome|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.
Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
230736|NCT01274533|O1|Outcome|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.
Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
230737|NCT01274533|E1|Reported Event|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.
Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
230738|NCT01274429|B1|Baseline|Open Label Peanut Flour|"Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
Peanut flour: Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose."
230739|NCT01274429|P1|Participant Flow|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
230740|NCT01274429|O1|Outcome|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
230741|NCT01274429|O1|Outcome|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
230742|NCT01274429|E1|Reported Event|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
230743|NCT01273896|B1|Baseline|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
230744|NCT01273896|P1|Participant Flow|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
230745|NCT01273896|O1|Outcome|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
230746|NCT01273896|E1|Reported Event|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
230747|NCT01273883|B1|Baseline|Entire Study Population|Includes groups randomized to receive magnesium first and placebo first.
230748|NCT01273883|P2|Participant Flow|Placebo First, Then Magnesium|Placebo daily for 25 days followed by 2 weeks of washout followed by magnesium 532 mg daily for 25 days.
230749|NCT01273883|P1|Participant Flow|Magnesium First, Then Placebo|Magnesium 532 mg daily for 25 days followed by 2 weeks of washout followed by 25 days of placebo.
230750|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
230751|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
230752|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
230753|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
230754|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
230755|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
230756|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
230757|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
230758|NCT01273883|E2|Reported Event|Placebo|Placebo administered daily in either first intervention period or second intervention period.
230759|NCT01273883|E1|Reported Event|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
230760|NCT01273857|B3|Baseline|Total|Total of all reporting groups
230761|NCT01273857|B2|Baseline|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure
Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.
staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
230920|NCT01273038|B1|Baseline|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
230763|NCT01273857|P2|Participant Flow|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure
Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.
staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
230764|NCT01273857|P1|Participant Flow|Control|"Subjects will undergo standard staged-procedures without cell infusion
staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
230765|NCT01273857|O2|Outcome|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure
Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.
staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
230766|NCT01273857|O1|Outcome|Control|"Subjects will undergo standard staged-procedures without cell infusion
staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
230767|NCT01273857|O2|Outcome|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure
Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.
staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
230768|NCT01273857|O1|Outcome|Control|"Subjects will undergo standard staged-procedures without cell infusion
staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
230769|NCT01273857|E2|Reported Event|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure
Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.
staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
230770|NCT01273857|E1|Reported Event|Control|"Subjects will undergo standard staged-procedures without cell infusion
staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
230771|NCT01273818|B4|Baseline|Total|Total of all reporting groups
230772|NCT01273818|B3|Baseline|Gentamicin+ Cefazolin Sodium|Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
230773|NCT01273818|B2|Baseline|Cephazolin|Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
230774|NCT01273818|B1|Baseline|Gentamicin|Gentamicin arm: application of 80 mg gentamycin topically
230775|NCT01273818|P3|Participant Flow|Gentamicin+ Cefazolin Sodium|Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
230776|NCT01273818|P2|Participant Flow|Cefazolin|Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
230777|NCT01273818|P1|Participant Flow|Gentamicin|Gentamicin arm: application of 80 mg gentamycin topically
230778|NCT01273818|O3|Outcome|Topical and iv|Total number of patients to which topical gentamicin and cephazoline (iv) was applied for prophylaxis
230779|NCT01273818|O2|Outcome|Cefazolin IV|Total number of patients to which ceephazoline (İV) was applied for prophylaxis
230780|NCT01273818|O1|Outcome|Topical Gentamicin|Total number of patients to which topical gentamicin was applied for prophylaxis
230781|NCT01273818|E3|Reported Event|Gentamicin+ Cefazolin Sodium|"Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose
No adverse effect"
230782|NCT01273818|E2|Reported Event|Cephazolin|"Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose
No adverse effect"
230783|NCT01273818|E1|Reported Event|Gentamicin|"Gentamicin arm: application of 80 mg gentamycin topically
Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose
No adverse effect"
230784|NCT01273805|B3|Baseline|Total|Total of all reporting groups
230785|NCT01273805|B2|Baseline|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230786|NCT01273805|B1|Baseline|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230787|NCT01273805|P2|Participant Flow|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230788|NCT01273805|P1|Participant Flow|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230789|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230790|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
243487|NCT01237327|B3|Baseline|Total|Total of all reporting groups
230791|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230792|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230793|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230794|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230795|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230796|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230797|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230798|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230799|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230800|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230801|NCT01273805|E2|Reported Event|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230802|NCT01273805|E1|Reported Event|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
230803|NCT01273766|B4|Baseline|Total|Total of all reporting groups
230804|NCT01273766|B3|Baseline|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
230805|NCT01273766|B2|Baseline|Control Arm|blood tested on healthy patients
230806|NCT01273766|B1|Baseline|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
deferasirox : Given orally
laboratory biomarker analysis : Correlative studies
enzyme-linked immunosorbent assay : Correlative studies"
230807|NCT01273766|P3|Participant Flow|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
230808|NCT01273766|P2|Participant Flow|Control Arm|blood tested on healthy patients
230809|NCT01273766|P1|Participant Flow|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
deferasirox : Given orally
laboratory biomarker analysis : Correlative studies
enzyme-linked immunosorbent assay : Correlative studies"
230810|NCT01273766|O1|Outcome|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
deferasirox : Given orally
laboratory biomarker analysis : Correlative studies
enzyme-linked immunosorbent assay : Correlative studies"
230811|NCT01273766|E3|Reported Event|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
230812|NCT01273766|E2|Reported Event|Control Arm|blood tested on healthy patients
230813|NCT01273766|E1|Reported Event|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
deferasirox : Given orally
laboratory biomarker analysis : Correlative studies
enzyme-linked immunosorbent assay : Correlative studies"
230814|NCT01273623|B1|Baseline|Single Arm|subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
230815|NCT01273623|P1|Participant Flow|Single Arm|subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
230816|NCT01273623|O1|Outcome|Study Participants|
230817|NCT01273623|O1|Outcome|Study Participants|
230818|NCT01273623|O2|Outcome|Post-atherectomy|after Jetstream use and prior to adjunctive therapies
230819|NCT01273623|O1|Outcome|Pre-atherectomy|prior to Jetstream use
230820|NCT01273623|E1|Reported Event|Study Participants|
230821|NCT01273597|B1|Baseline|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230822|NCT01273597|P1|Participant Flow|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230823|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230824|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230825|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230826|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230827|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230828|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230829|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230830|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230831|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230832|NCT01273597|E1|Reported Event|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
230833|NCT01273519|B4|Baseline|Total|Total of all reporting groups
230834|NCT01273519|B3|Baseline|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230835|NCT01273519|B2|Baseline|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230836|NCT01273519|B1|Baseline|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230837|NCT01273519|P3|Participant Flow|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230838|NCT01273519|P2|Participant Flow|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230839|NCT01273519|P1|Participant Flow|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230840|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230841|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230842|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230843|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230844|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230845|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230846|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230847|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230848|NCT01273519|O1|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230849|NCT01273519|O1|Outcome|PsA, AS|Participants with psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230850|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230851|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230852|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230853|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230854|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230855|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230856|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230857|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230858|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230859|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230860|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230861|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230862|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230863|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230864|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230865|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230866|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230867|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230868|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230869|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230870|NCT01273519|E1|Reported Event|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
230871|NCT01273181|B5|Baseline|Total|Total of all reporting groups
230872|NCT01273181|B4|Baseline|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230873|NCT01273181|B3|Baseline|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230874|NCT01273181|B2|Baseline|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230875|NCT01273181|B1|Baseline|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230876|NCT01273181|P4|Participant Flow|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Other cancers
230877|NCT01273181|P3|Participant Flow|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC
230878|NCT01273181|P2|Participant Flow|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230879|NCT01273181|P1|Participant Flow|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230880|NCT01273181|O4|Outcome|Anti-MAGE TCR PBL +HD IL-2, Other|"anti-MAGE A3/12 TCR PBL MTD +HD-IL-1 Other cancers
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230881|NCT01273181|O3|Outcome|Anti-MAGE TCR PBL+HD IL-2, Mel, RCC|"anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230882|NCT01273181|O2|Outcome|Anti-MAGE TCR PBL 5x10e10 +HD IL-2|"anti-MAGE A3/12 TCR PBL 5x10e9 to 3 x 10e10 + HD IL-2
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230883|NCT01273181|O1|Outcome|Anti-MAGE TCR PBL 5x10e9 +HD IL-2|"anti-MAGE A3/12 TCR PBL 3x10e10 to 1 x 10e11 + HD IL-2
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230884|NCT01273181|O4|Outcome|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230885|NCT01273181|O3|Outcome|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230886|NCT01273181|O2|Outcome|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230887|NCT01273181|O1|Outcome|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230888|NCT01273181|E4|Reported Event|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230889|NCT01273181|E3|Reported Event|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230890|NCT01273181|E2|Reported Event|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230891|NCT01273181|E1|Reported Event|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)
Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses
PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :
Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
230892|NCT01273064|B6|Baseline|Total|Total of all reporting groups
230921|NCT01273038|P2|Participant Flow|SenSura First (Reference Filter), Then Morfeus (Test Filter)|First Intervention with SenSura (14 days) then Second Intervention with Morfeus (14 days)
230922|NCT01273038|P1|Participant Flow|Morfeus First (Test Filter), Then SenSura (Reference Filter)|First Intervention with Morfeus (14 days) then Second Intervention with SenSura (14 days)
230893|NCT01273064|B5|Baseline|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
230894|NCT01273064|B4|Baseline|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
230895|NCT01273064|B3|Baseline|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
230896|NCT01273064|B2|Baseline|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
230897|NCT01273064|B1|Baseline|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
230898|NCT01273064|P5|Participant Flow|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
230899|NCT01273064|P4|Participant Flow|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
230900|NCT01273064|P3|Participant Flow|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
230901|NCT01273064|P2|Participant Flow|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
230902|NCT01273064|P1|Participant Flow|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
230903|NCT01273064|O5|Outcome|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
230904|NCT01273064|O4|Outcome|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
230905|NCT01273064|O3|Outcome|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
230906|NCT01273064|O2|Outcome|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
230907|NCT01273064|O1|Outcome|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
230908|NCT01273064|O5|Outcome|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
230909|NCT01273064|O4|Outcome|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
230910|NCT01273064|O3|Outcome|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
230911|NCT01273064|O2|Outcome|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
230912|NCT01273064|O1|Outcome|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
230913|NCT01273064|E5|Reported Event|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
230914|NCT01273064|E4|Reported Event|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
230915|NCT01273064|E3|Reported Event|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
230916|NCT01273064|E2|Reported Event|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
230917|NCT01273064|E1|Reported Event|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
230923|NCT01273038|O2|Outcome|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
230924|NCT01273038|O1|Outcome|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
230925|NCT01273038|E2|Reported Event|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
230926|NCT01273038|E1|Reported Event|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
230927|NCT01272947|B3|Baseline|Total|Total of all reporting groups
230928|NCT01272947|B2|Baseline|Placebo|
230929|NCT01272947|B1|Baseline|Diclofenac Sodium Topical Gel 1%|
230930|NCT01272947|P2|Participant Flow|Placebo|
230931|NCT01272947|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|
230932|NCT01272947|O2|Outcome|Placebo|
230933|NCT01272947|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
230934|NCT01272947|O2|Outcome|Placebo|
230935|NCT01272947|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
230936|NCT01272947|E2|Reported Event|Placebo|
230937|NCT01272947|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|
230938|NCT01272934|B3|Baseline|Total|Total of all reporting groups
230939|NCT01272934|B2|Baseline|Placebo|Placebo : Topical gel-4 times daily
230940|NCT01272934|B1|Baseline|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%
Diclofenac Sodium : Topical gel 1%-4 times daily"
230941|NCT01272934|P2|Participant Flow|Placebo|Placebo : Topical gel-4 times daily
230942|NCT01272934|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%
Diclofenac Sodium : Topical gel 1%-4 times daily"
230943|NCT01272934|O2|Outcome|Placebo|
230944|NCT01272934|O1|Outcome|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%
Diclofenac Sodium : Topical gel 1%-4 times daily"
230945|NCT01272934|O2|Outcome|Placebo|Placebo : Topical gel-4 times daily
230946|NCT01272934|O1|Outcome|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%
Diclofenac Sodium : Topical gel 1%-4 times daily"
230947|NCT01272934|E2|Reported Event|Placebo|Placebo : Topical gel-4 times daily
230948|NCT01272934|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%
Diclofenac Sodium : Topical gel 1%-4 times daily"
230949|NCT01272921|B3|Baseline|Total|Total of all reporting groups
230950|NCT01272921|B2|Baseline|GROUP 2|"Varying does to determine duration of analgesia following a sciatic nerve block
Ropivacaine : Varying doses to determine the duration of analgesia"
230951|NCT01272921|B1|Baseline|GROUP 1|"Varying does to determine duration of analgesia following a sciatic nerve block
Bupivacaine : Varying doses to determine the duration of analgesia"
230952|NCT01272921|P2|Participant Flow|Ropivacaine|"Varying does to determine duration of analgesia following a sciatic nerve block
Ropivacaine : Varying doses to determine the duration of analgesia"
230953|NCT01272921|P1|Participant Flow|Bupivacaine|"Varying does to determine duration of analgesia following a sciatic nerve block
Bupivacaine : Varying doses to determine the duration of analgesia"
230954|NCT01272921|O2|Outcome|Ropivacaine|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block
Ropivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
230955|NCT01272921|O1|Outcome|Bupivacaine|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block
Bupivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
230956|NCT01272921|O2|Outcome|Below CIEL|The mean threshold current required to elicit a motor response below the common investing extraneural layer (CIEL).
230957|NCT01272921|O1|Outcome|Above CIEL|The mean threshold current required to elicit a motor response above the common investing extraneural layer (CIEL).
230958|NCT01272921|E2|Reported Event|GROUP 2|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block
Ropivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
230959|NCT01272921|E1|Reported Event|GROUP 1|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block
Bupivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
230960|NCT01272908|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230961|NCT01272908|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg per week (mg/week) and a stable dose of folate (greater than or equal to [≥]5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (Disease Activity Score based on 28-Joint Count [DAS28] score of greater than or equal to [≥]2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg], given 14 days apart), at any time between Week 24 and 48.
230962|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
233390|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
230963|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230964|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230965|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230966|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230967|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230968|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230969|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230970|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230971|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230972|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230973|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230974|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230975|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
231024|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
245192|NCT01231607|B6|Baseline|Total|Total of all reporting groups
230976|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230977|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230978|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230979|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230980|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230981|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230982|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230983|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230984|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230985|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230986|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230987|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230988|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
231025|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
248098|NCT01225562|O3|Outcome|Placebo|Matching placebo
230989|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230990|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230991|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230992|NCT01272908|E2|Reported Event|Re-treatment: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
230993|NCT01272908|E1|Reported Event|Initial Treatment: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
230994|NCT01272882|B1|Baseline|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.
Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
230995|NCT01272882|P1|Participant Flow|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.
Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
230996|NCT01272882|O1|Outcome|Adults With ARDS or ALI|Adults with PaO2/FiO2 ratio less than 300. Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device
230997|NCT01272882|E1|Reported Event|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.
Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
230998|NCT01272869|B3|Baseline|Total|Total of all reporting groups
230999|NCT01272869|B2|Baseline|Morfeus|The test product is the product with the proposed new filter (Morfeus)
231000|NCT01272869|B1|Baseline|Sensura|The reference product is the SenSura product which is already commercially available
231001|NCT01272869|P2|Participant Flow|Morfeus First; Then Sensura|The test product with the Morfeus filter is the test product with the proposed new filter.
231002|NCT01272869|P1|Participant Flow|Sensura First; Then Morfeus|The reference product is the SenSura product which is already commercially available
231003|NCT01272869|O2|Outcome|Morfeus|The test product is the product with the proposed new filter (Morfeus)
231004|NCT01272869|O1|Outcome|Sensura|SenSura is the reference product and the product is already commercially available
231005|NCT01272869|E2|Reported Event|Morfeus|The test product is the product with the proposed new filter (Morfeus)
231006|NCT01272869|E1|Reported Event|Sensura|The reference product is the SenSura product which is already commercially available
231007|NCT01272804|B7|Baseline|Total|Total of all reporting groups
231008|NCT01272804|B6|Baseline|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231009|NCT01272804|B5|Baseline|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231010|NCT01272804|B4|Baseline|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231011|NCT01272804|B3|Baseline|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231012|NCT01272804|B2|Baseline|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231013|NCT01272804|B1|Baseline|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231014|NCT01272804|P6|Participant Flow|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231015|NCT01272804|P5|Participant Flow|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231016|NCT01272804|P4|Participant Flow|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231017|NCT01272804|P3|Participant Flow|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231018|NCT01272804|P2|Participant Flow|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231019|NCT01272804|P1|Participant Flow|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231020|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231021|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231022|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231023|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
233391|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
231026|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231027|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231028|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231029|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231030|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231031|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231032|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231033|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231034|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231035|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231036|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231037|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231038|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231039|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231040|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231041|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231042|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231043|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231044|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231045|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231046|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231047|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231048|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231049|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231050|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231051|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231052|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231053|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231054|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231055|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231056|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231057|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231058|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231059|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231060|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231061|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231062|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231063|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231064|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231065|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231066|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231067|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231068|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231069|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231070|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231071|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231072|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231073|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231074|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231075|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231076|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231077|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231078|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231079|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231080|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231081|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231082|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231083|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231084|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231085|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231086|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231087|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231088|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231089|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231090|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231091|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231092|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231093|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231094|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231095|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231096|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231097|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231098|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231099|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231100|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231101|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231102|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231103|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231104|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231105|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231106|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231107|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231108|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231109|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231110|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231111|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231112|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231113|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231114|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231115|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231116|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231117|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231118|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231119|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231120|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231121|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231122|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
233392|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
231123|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231124|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231125|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231126|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231127|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231128|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231129|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231130|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231131|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231132|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231133|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231134|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231135|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231136|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231137|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231138|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231139|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231140|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231141|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231142|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231143|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231144|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231145|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231146|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231147|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231148|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231149|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231150|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231151|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231152|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231153|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231154|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231155|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231156|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231157|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231158|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231159|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231160|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231161|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231162|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231163|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231164|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
231165|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231166|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231167|NCT01272804|E6|Reported Event|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
231168|NCT01272804|E5|Reported Event|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
231169|NCT01272804|E4|Reported Event|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
231170|NCT01272804|E3|Reported Event|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
233393|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
231171|NCT01272804|E2|Reported Event|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
231172|NCT01272804|E1|Reported Event|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
231173|NCT01272661|B4|Baseline|Total|Total of all reporting groups
231174|NCT01272661|B3|Baseline|Enhanced Curriculum+Father Support|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
231175|NCT01272661|B2|Baseline|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
231176|NCT01272661|B1|Baseline|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
231177|NCT01272661|P3|Participant Flow|Enhanced Curriculum +Father Support|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
231178|NCT01272661|P2|Participant Flow|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
231179|NCT01272661|P1|Participant Flow|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
231180|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
231181|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
231182|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
231183|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
231184|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
231185|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
231186|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
231187|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
231188|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
231189|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
231218|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231190|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
231191|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
231192|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
231193|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
231194|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
231195|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
231196|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
231197|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
231198|NCT01272661|E3|Reported Event|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
231199|NCT01272661|E2|Reported Event|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)
Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
231200|NCT01272661|E1|Reported Event|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
231201|NCT01272635|B3|Baseline|Total|Total of all reporting groups
231202|NCT01272635|B2|Baseline|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231203|NCT01272635|B1|Baseline|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231204|NCT01272635|P4|Participant Flow|Placebo/Placebo|"Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
231205|NCT01272635|P3|Participant Flow|Placebo/Prednisolone|"Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
231206|NCT01272635|P2|Participant Flow|Azithromycin/Placebo|"Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
231207|NCT01272635|P1|Participant Flow|Azithromycin/Prednisolone|"Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
231208|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231209|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231210|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231211|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231212|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231213|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231214|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231215|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231216|NCT01272635|O2|Outcome|Placebo|Placebo Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
231217|NCT01272635|O1|Outcome|Prednisone|Active Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
233394|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
231219|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231220|NCT01272635|E2|Reported Event|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231221|NCT01272635|E1|Reported Event|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
231222|NCT01272583|B3|Baseline|Total|Total of all reporting groups
231223|NCT01272583|B2|Baseline|Sequence B (Placebo→Sitagliptin)|"Cross-over, both arms reveived the same intervention in different order.
Sitagliptin : 100 mg once daily for six weeks
Placebo : placebo, once daily for six weeks"
231224|NCT01272583|B1|Baseline|Sequence A (Sitagliptin→Placebo)|"Cross-over, both arms reveived the same intervention in different order.
Sitagliptin : 100 mg once daily for six weeks
Placebo : placebo, once daily for six weeks"
231225|NCT01272583|P2|Participant Flow|Sequence B (Placebo→Sitagliptin)|"Cross-over, both arms reveived the same intervention in different order.
Sitagliptin : 100 mg once daily for six weeks
Placebo : placebo, once daily for six weeks"
231226|NCT01272583|P1|Participant Flow|Sequence A (Sitagliptin→Placebo)|"Cross-over, both arms reveived the same intervention in different order.
Sitagliptin : 100 mg once daily for six weeks
Placebo : placebo, once daily for six weeks"
231227|NCT01272583|O3|Outcome|Placebo|
231228|NCT01272583|O2|Outcome|Sitagliptin Treatment|
231229|NCT01272583|O1|Outcome|Baseline|
231230|NCT01272583|O3|Outcome|Placebo|
231231|NCT01272583|O2|Outcome|Sitagliptin Treatment|
231232|NCT01272583|O1|Outcome|Baseline|
231233|NCT01272583|O3|Outcome|Placebo|
231234|NCT01272583|O2|Outcome|Sitagliptin Treatment|
231235|NCT01272583|O1|Outcome|Baseline|
231236|NCT01272583|O3|Outcome|Placebo|
231237|NCT01272583|O2|Outcome|Sitagliptin Treatment|
231238|NCT01272583|O1|Outcome|Baseline|
231239|NCT01272583|O3|Outcome|Placebo|
231240|NCT01272583|O2|Outcome|Sitagliptin Treatment|
231241|NCT01272583|O1|Outcome|Baseline|
231242|NCT01272583|O3|Outcome|Placebo|
231243|NCT01272583|O2|Outcome|Sitagliptin Treatment|
231244|NCT01272583|O1|Outcome|Baseline|
231245|NCT01272583|O3|Outcome|Placebo|
231246|NCT01272583|O2|Outcome|Sitagliptin Treatment|
231247|NCT01272583|O1|Outcome|Baseline|
231248|NCT01272583|O3|Outcome|Placebo|
231249|NCT01272583|O2|Outcome|Sitagliptin Treatment|
231250|NCT01272583|O1|Outcome|Baseline|
231251|NCT01272583|E3|Reported Event|Placebo|
231252|NCT01272583|E2|Reported Event|Sitagliptin Treatment|
231253|NCT01272583|E1|Reported Event|Baseline|
231254|NCT01272284|B1|Baseline|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231255|NCT01272284|P1|Participant Flow|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231256|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231257|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231258|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231259|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231260|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231261|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231262|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231263|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231264|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231265|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231266|NCT01272284|O1|Outcome|Altis SIS®|Participants implanted with Altis® Single Incision Sling
231267|NCT01272284|E1|Reported Event|Altis® SIS|Participants implanted with Altis® Single Incision Sling
231268|NCT01272232|B4|Baseline|Total|Total of all reporting groups
231269|NCT01272232|B3|Baseline|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231270|NCT01272232|B2|Baseline|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231271|NCT01272232|B1|Baseline|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231272|NCT01272232|P3|Participant Flow|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231418|NCT01272141|B1|Baseline|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily
Everolimus: 5mg by mouth daily"
231273|NCT01272232|P2|Participant Flow|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231274|NCT01272232|P1|Participant Flow|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231275|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231276|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231277|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231278|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231279|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231280|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231281|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231282|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231283|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231284|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231285|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231419|NCT01272141|P1|Participant Flow|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily
Everolimus: 5mg by mouth daily"
231286|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231287|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231288|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231289|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231290|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231291|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231292|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231293|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231294|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231295|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231296|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231297|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231298|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231420|NCT01272141|O1|Outcome|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily
Everolimus: 5mg by mouth daily"
231299|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231300|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231301|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231302|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231303|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231304|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231305|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231306|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231307|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231308|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231309|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231310|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231311|NCT01272232|E3|Reported Event|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231421|NCT01272141|O1|Outcome|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily
Everolimus: 5mg by mouth daily"
248740|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
231312|NCT01272232|E2|Reported Event|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231313|NCT01272232|E1|Reported Event|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
231314|NCT01272219|B5|Baseline|Total|Total of all reporting groups
231315|NCT01272219|B4|Baseline|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
231316|NCT01272219|B3|Baseline|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
231317|NCT01272219|B2|Baseline|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
231318|NCT01272219|B1|Baseline|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
231319|NCT01272219|P6|Participant Flow|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
231320|NCT01272219|P5|Participant Flow|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
231321|NCT01272219|P4|Participant Flow|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
231322|NCT01272219|P3|Participant Flow|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
231323|NCT01272219|P2|Participant Flow|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
231324|NCT01272219|P1|Participant Flow|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
231325|NCT01272219|O3|Outcome|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
231326|NCT01272219|O2|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
231327|NCT01272219|O1|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
231372|NCT01272193|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
231328|NCT01272219|O3|Outcome|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
231329|NCT01272219|O2|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
231330|NCT01272219|O1|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
231331|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
231332|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
231333|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
231334|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
231335|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
231336|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
231337|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
231338|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
231339|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
231340|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
231341|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
231342|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
231343|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
231344|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
231345|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
231346|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
231347|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
231348|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
231349|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
231350|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
231351|NCT01272219|E4|Reported Event|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
231766|NCT01271036|O1|Outcome|Male|Male Participants
248741|NCT01222520|O2|Outcome|Telmisartan|
231352|NCT01272219|E3|Reported Event|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
231353|NCT01272219|E2|Reported Event|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
231354|NCT01272219|E1|Reported Event|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
231355|NCT01272193|B3|Baseline|Total|Total of all reporting groups
231356|NCT01272193|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
231357|NCT01272193|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
231358|NCT01272193|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
231359|NCT01272193|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
231360|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
231361|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
231362|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
231363|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
231364|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
231365|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
231366|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
231367|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
231368|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
231369|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
231370|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
231371|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
231767|NCT01271036|O2|Outcome|Female|Female Participants
231373|NCT01272193|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
231374|NCT01272180|B5|Baseline|Total|Total of all reporting groups
231375|NCT01272180|B4|Baseline|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
231376|NCT01272180|B3|Baseline|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart.
231377|NCT01272180|B2|Baseline|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231378|NCT01272180|B1|Baseline|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231379|NCT01272180|P4|Participant Flow|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
231380|NCT01272180|P3|Participant Flow|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart.
231381|NCT01272180|P2|Participant Flow|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231382|NCT01272180|P1|Participant Flow|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231383|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231384|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231385|NCT01272180|O4|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
231386|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
231387|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231388|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231389|NCT01272180|O4|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
231390|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
231391|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231392|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231393|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
231394|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231395|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231396|NCT01272180|O3|Outcome|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart.
231397|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231398|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231399|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
231400|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231401|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231402|NCT01272180|O3|Outcome|rMenB +OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
231403|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231404|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231405|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
231406|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231407|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231408|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
231409|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231410|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231411|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
231412|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
231413|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
231414|NCT01272180|E4|Reported Event|ACWY|Subjects in this group received first dose of placebo followed by one dose of MenACWY vaccine administered two months apart.
231415|NCT01272180|E3|Reported Event|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart.
231416|NCT01272180|E2|Reported Event|ABCWY+qOMV|"Subjects in this group received two doses of rMenB (+ OMV_1/4th dose)
+and MenACWY combination vaccine, administered two months apart."
231417|NCT01272180|E1|Reported Event|ABCWY+OMV|Subjects in this group received two doses of rMenB(+ OMV_full dose) and MenACWY combination vaccine, administered two months apart.
231422|NCT01272141|E1|Reported Event|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily
Everolimus: 5mg by mouth daily"
231423|NCT01272076|B1|Baseline|GA Group|Patients diagnosed with dry AMD and geographic atrophy
231424|NCT01272076|P1|Participant Flow|Dry AMD With Geographic Atrophy|Patients diagnosed with dry AMD and geographic atrophy
231425|NCT01272076|O1|Outcome|GA Group|Inter-device variability in measuring the area of Geographic Atrophy. 3 acceptable scans from 3 Cirrus HD-OCT devices (total of 9) were taken by one operator in this phase.
231426|NCT01272076|E1|Reported Event|GA Group|Patients with dry age related macular degeneration and geographic atrophy.
231427|NCT01272011|B4|Baseline|Total|Total of all reporting groups
231428|NCT01272011|B3|Baseline|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
231429|NCT01272011|B2|Baseline|Phase 2 Arm (Long Term Facilitation)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
231430|NCT01272011|B1|Baseline|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
231431|NCT01272011|P3|Participant Flow|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
231432|NCT01272011|P2|Participant Flow|Phase 2 Arm (LTF)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
231433|NCT01272011|P1|Participant Flow|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
231434|NCT01272011|O3|Outcome|Phase 3 Arm (Ventilatory Loading)|"Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.
Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
231435|NCT01272011|O2|Outcome|Phase 2 Arm (LTF)|"Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation.
Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
231436|NCT01272011|O1|Outcome|Phase 1 Arm (Pilot)|"Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)
Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.
Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns."
231437|NCT01272011|O3|Outcome|Phase 3 Arm (Ventilatory Loading)|"Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.
Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
231438|NCT01272011|O2|Outcome|Phase 2 Arm (LTF)|"Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation.
Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
231439|NCT01272011|O1|Outcome|Phase 1 Arm (Pilot)|"Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)
Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.
Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns."
231440|NCT01272011|E3|Reported Event|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
231441|NCT01272011|E2|Reported Event|Phase 2 Arm (Long Term Facilitation)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
231442|NCT01272011|E1|Reported Event|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
231443|NCT01271946|B3|Baseline|Total|Total of all reporting groups
231444|NCT01271946|B2|Baseline|Sheath Greater Than 6F|
231445|NCT01271946|B1|Baseline|Intent to Treat|
231446|NCT01271946|P2|Participant Flow|Sheath Greater Than 6 French (F)|Subjects in whom the procedural sheath was upsized to greater than 6F.
231447|NCT01271946|P1|Participant Flow|Intent to Treat (ITT)|The ITT cohort consists of those subjects where an attempt was made to place the Arstasis device into subject's vasculature regardless of whether or not this attempt was successful.
231448|NCT01271946|O1|Outcome|Per Protocol|Time to Ambulation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
231449|NCT01271946|O1|Outcome|Per Protocol|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
231450|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Bed Elevation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
231451|NCT01271946|O1|Outcome|Intent to Treat|Time to Bed Elevation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
231452|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Ambulation was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
231453|NCT01271946|O1|Outcome|Intent to Treat|Time to Ambulation was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
231454|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
231455|NCT01271946|O1|Outcome|Intent to Treat|Time to Actual Discharge was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
231456|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
231457|NCT01271946|O1|Outcome|Group 1|Time to Discharge Eligibility was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
231458|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
231459|NCT01271946|O1|Outcome|Intent to Treat|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
231460|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Minor access site-related complications observed in subjects who were upsized to sheath size greater than 6F.
231461|NCT01271946|O1|Outcome|Group 1|Minor access site-related complications observed in the intent-to-treat population.
231462|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
231463|NCT01271946|O1|Outcome|Intent to Treat|
231464|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Major access site-related complications observed in subjects treated with sheath size greater than 6F.
231465|NCT01271946|O1|Outcome|Intent to Treat|Major access site-related complications observed in the intent-to-treat population.
231466|NCT01271946|E2|Reported Event|Sheath Greater Than 6F|
231467|NCT01271946|E1|Reported Event|Intent to Treat|
231468|NCT01271907|B4|Baseline|Total|Total of all reporting groups
231469|NCT01271907|B3|Baseline|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells
3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
231470|NCT01271907|B2|Baseline|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2
2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231471|NCT01271907|B1|Baseline|Cohort 0|"Drosophila generated CTL + SQ IL-2
1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231472|NCT01271907|P3|Participant Flow|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells
3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
231473|NCT01271907|P2|Participant Flow|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2
2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231474|NCT01271907|P1|Participant Flow|Cohort 0|"Drosophila generated CTL + SQ IL-2
1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231475|NCT01271907|O3|Outcome|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells
3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
231476|NCT01271907|O2|Outcome|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2
2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231477|NCT01271907|O1|Outcome|Cohort 0|"Drosophila generated CTL + SQ IL-2
1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231478|NCT01271907|O3|Outcome|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells
3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
231479|NCT01271907|O2|Outcome|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2
2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231480|NCT01271907|O1|Outcome|Cohort 0|"Drosophila generated CTL + SQ IL-2
1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231481|NCT01271907|O3|Outcome|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells
3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
231482|NCT01271907|O2|Outcome|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2
2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231483|NCT01271907|O1|Outcome|Cohort 0|"Drosophila generated CTL + SQ IL-2
1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231484|NCT01271907|E3|Reported Event|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells
3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
231485|NCT01271907|E2|Reported Event|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2
2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231768|NCT01271036|O1|Outcome|Male|Male Participants
231486|NCT01271907|E1|Reported Event|Cohort 0|"Drosophila generated CTL + SQ IL-2
1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
231487|NCT01271803|B13|Baseline|Total|Total of all reporting groups
231488|NCT01271803|B12|Baseline|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231489|NCT01271803|B11|Baseline|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231490|NCT01271803|B10|Baseline|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231491|NCT01271803|B9|Baseline|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231492|NCT01271803|B8|Baseline|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231493|NCT01271803|B7|Baseline|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231494|NCT01271803|B6|Baseline|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231495|NCT01271803|B5|Baseline|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231496|NCT01271803|B4|Baseline|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231497|NCT01271803|B3|Baseline|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231498|NCT01271803|B2|Baseline|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231499|NCT01271803|B1|Baseline|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231500|NCT01271803|P12|Participant Flow|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231501|NCT01271803|P11|Participant Flow|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231502|NCT01271803|P10|Participant Flow|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231503|NCT01271803|P9|Participant Flow|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231504|NCT01271803|P8|Participant Flow|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231505|NCT01271803|P7|Participant Flow|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231506|NCT01271803|P6|Participant Flow|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231507|NCT01271803|P5|Participant Flow|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231769|NCT01271036|O2|Outcome|Female|Female Participants
231770|NCT01271036|O1|Outcome|Male|Male Participants
231508|NCT01271803|P4|Participant Flow|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on Days 1-28 (28/0 dosing schedule) and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231509|NCT01271803|P3|Participant Flow|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231510|NCT01271803|P2|Participant Flow|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on Days 1-21, followed by 7 days off on Days 22-28 (21/7 dosing schedule) and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231511|NCT01271803|P1|Participant Flow|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 milligrams (mg) cobimetinib once daily (QD) on Days 1-14, followed by 14 days off on Days 15-28 (14/14 dosing schedule) and oral 720 mg vemurafenib twice daily (BID) on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231512|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231513|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231514|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231515|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231516|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231517|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231518|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231519|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231520|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231521|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231522|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231523|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231524|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231771|NCT01271036|O2|Outcome|Female|Female Participants
231772|NCT01271036|O1|Outcome|Male|Male Participants
231525|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231526|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231527|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231528|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231529|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231530|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231531|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231532|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231533|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231534|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231535|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231536|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231537|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231538|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231539|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231540|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231541|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231542|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231543|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231544|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231545|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231546|NCT01271803|O8|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231547|NCT01271803|O7|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231548|NCT01271803|O6|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231549|NCT01271803|O5|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231550|NCT01271803|O4|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231551|NCT01271803|O3|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231552|NCT01271803|O2|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231553|NCT01271803|O1|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231554|NCT01271803|O1|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231555|NCT01271803|O7|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231556|NCT01271803|O6|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231557|NCT01271803|O5|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231558|NCT01271803|O4|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231559|NCT01271803|O3|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231560|NCT01271803|O2|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231561|NCT01271803|O1|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231562|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231563|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231564|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231565|NCT01271803|O7|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231566|NCT01271803|O6|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231567|NCT01271803|O5|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231568|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231569|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231570|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231571|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231572|NCT01271803|O2|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231573|NCT01271803|O1|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231574|NCT01271803|O8|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231575|NCT01271803|O7|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231576|NCT01271803|O6|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231577|NCT01271803|O5|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231578|NCT01271803|O4|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231579|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231580|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231581|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231582|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231583|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231584|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231585|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231586|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231587|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231588|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231589|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231590|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231591|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231592|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231593|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231594|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231595|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231596|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231597|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231598|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231599|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231600|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231601|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231602|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231603|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231604|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231605|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231606|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231607|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231608|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231609|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231610|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231611|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231612|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231613|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231614|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231615|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231616|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231617|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231618|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231619|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231620|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231621|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231622|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231623|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231624|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231625|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231626|NCT01271803|O1|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231627|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231628|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231629|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231630|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231631|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231632|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231633|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231634|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231635|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231636|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231637|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231638|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231639|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231640|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231641|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231642|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231643|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231644|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231645|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231646|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231647|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231648|NCT01271803|O1|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231649|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231650|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231651|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231652|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231653|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231654|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231655|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231656|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231657|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231658|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231659|NCT01271803|O1|Outcome|Dose Escalation Stage (Stage 1)|All participants who received vemurafenib and cobimetinib in any dose combination during DES, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
231660|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231661|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231662|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231663|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231664|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231665|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231666|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231667|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231668|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231669|NCT01271803|E12|Reported Event|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231670|NCT01271803|E11|Reported Event|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231671|NCT01271803|E10|Reported Event|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231672|NCT01271803|E9|Reported Event|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231673|NCT01271803|E8|Reported Event|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231674|NCT01271803|E7|Reported Event|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231675|NCT01271803|E6|Reported Event|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231676|NCT01271803|E5|Reported Event|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231677|NCT01271803|E4|Reported Event|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231678|NCT01271803|E3|Reported Event|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231679|NCT01271803|E2|Reported Event|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231680|NCT01271803|E1|Reported Event|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
231681|NCT01271712|B3|Baseline|Total|Total of all reporting groups
231682|NCT01271712|B2|Baseline|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231683|NCT01271712|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231684|NCT01271712|P2|Participant Flow|Placebo First, Then Option of Open Label Regorafenib Treatment|Double blind phase: participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Open Label phase: participants on placebo who switched to Regorafenib, received Regorafenib 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.
231685|NCT01271712|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231686|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231687|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231688|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231689|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231690|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231691|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231692|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231693|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231694|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231695|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231696|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231697|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231698|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231699|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231700|NCT01271712|E4|Reported Event|Placebo, Open Label Only (Switch to Regorafenib)|Switch to Regorafenib (Open Label study phase only): Participants switched to Open label Regorafenib treatment from Placebo. Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231701|NCT01271712|E3|Reported Event|Regorafenib, Open Label Only (Regorafenib Continued)|Continue Regorafenib (Open Label study phase only): Participants continue to receive Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231702|NCT01271712|E2|Reported Event|Placebo ( Double Blind Only)|Placebo (Double Blind study phase only): Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231703|NCT01271712|E1|Reported Event|Regorafenib (Double Blind Only)|Regorafenib (Double Blind study phase only): Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
231704|NCT01271686|B1|Baseline|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost once in the evening for 4 weeks
231705|NCT01271686|P1|Participant Flow|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
231706|NCT01271686|O1|Outcome|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
231707|NCT01271686|E1|Reported Event|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
231708|NCT01271543|B3|Baseline|Total|Total of all reporting groups
231773|NCT01271036|O2|Outcome|Female|Female Participants
231774|NCT01271036|O1|Outcome|Male|Male Participants
231775|NCT01271036|E2|Reported Event|Female|Female Participants
231776|NCT01271036|E1|Reported Event|Male|Male Participants
231777|NCT01270971|B3|Baseline|Total|Total of all reporting groups
231709|NCT01271543|B2|Baseline|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
231710|NCT01271543|B1|Baseline|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
231711|NCT01271543|P2|Participant Flow|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
231712|NCT01271543|P1|Participant Flow|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
231713|NCT01271543|O2|Outcome|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
231714|NCT01271543|O1|Outcome|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
231715|NCT01271543|O2|Outcome|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
231716|NCT01271543|O1|Outcome|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
231717|NCT01271543|E2|Reported Event|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
231778|NCT01270971|B2|Baseline|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
231718|NCT01271543|E1|Reported Event|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
231719|NCT01271452|B3|Baseline|Total|Total of all reporting groups
231720|NCT01271452|B2|Baseline|Bocouture®|botulinum toxin type A (Bocouture®)
231721|NCT01271452|B1|Baseline|Vistabel®|botulinum toxin type A (Vistabel®)
231722|NCT01271452|P2|Participant Flow|Bocouture®|botulinum toxin type A (Bocouture®)
231723|NCT01271452|P1|Participant Flow|Vistabel®|botulinum toxin type A (Vistabel®)
231724|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
231725|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
231726|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
231727|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
231728|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
231729|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
231730|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
231731|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
231732|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
231733|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
231734|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
231735|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
231736|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
231737|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
231738|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
231739|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
231740|NCT01271452|E2|Reported Event|Bocouture®|botulinum toxin type A (Bocouture®)
231741|NCT01271452|E1|Reported Event|Vistabel®|botulinum toxin type A (Vistabel®)
231742|NCT01271413|B3|Baseline|Total|Total of all reporting groups
231743|NCT01271413|B2|Baseline|Cognitively Stimulating Activities: Other|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
231744|NCT01271413|B1|Baseline|Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
231745|NCT01271413|P2|Participant Flow|Non-adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
231746|NCT01271413|P1|Participant Flow|Adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
231747|NCT01271413|O2|Outcome|Non-adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
231748|NCT01271413|O1|Outcome|Adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
231749|NCT01271413|E2|Reported Event|Cognitively Stimulating Activities: Other|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
231750|NCT01271413|E1|Reported Event|Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
231751|NCT01271244|B3|Baseline|Total|Total of all reporting groups
231752|NCT01271244|B2|Baseline|Major Depression Group|Veterans with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
231753|NCT01271244|B1|Baseline|PTSD Depression Group|Veterans with PTSD and Depression will receive Escitalopram: 10-20mg daily for 12 weeks
231754|NCT01271244|P2|Participant Flow|Major Depression Group|Veteran with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
231755|NCT01271244|P1|Participant Flow|PTSD Depression Group|Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks
231756|NCT01271244|O2|Outcome|Major Depression Group|Veterans with major depression onny receive Escitalopram: 10-20mg daily for 12 weeks
231757|NCT01271244|O1|Outcome|PTSD Depression Group|Veterans with PTSD and depession will receive Escitalopram: 10-20mg daily for 12 weeks
231758|NCT01271244|E2|Reported Event|Major Depression Group|Veterans with Major Depression only receive Escitalopram: 10-20mg daily for 12 weeks
231759|NCT01271244|E1|Reported Event|PTSD Depression Group|Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks
231760|NCT01271036|B3|Baseline|Total|Total of all reporting groups
231761|NCT01271036|B2|Baseline|Female|Female Participants
231762|NCT01271036|B1|Baseline|Male|Male Participants
231763|NCT01271036|P2|Participant Flow|Female|Female Participants (K-Y Brand TOUCH 2-in-1)
231764|NCT01271036|P1|Participant Flow|Males|Male Participants (K-Y Brand TOUCH 2-in-1)
231765|NCT01271036|O2|Outcome|Female|Female Participants
231779|NCT01270971|B1|Baseline|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
231780|NCT01270971|P2|Participant Flow|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
231781|NCT01270971|P1|Participant Flow|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
231782|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
231783|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
231784|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
231785|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
231786|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
231787|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
231788|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
231789|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
231790|NCT01270971|E2|Reported Event|Solution Vehicle|"Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
231791|NCT01270971|E1|Reported Event|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
231792|NCT01270958|B1|Baseline|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231793|NCT01270958|P1|Participant Flow|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231794|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231795|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231796|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231797|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231798|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231799|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231800|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231801|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231802|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231803|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231804|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231805|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231806|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231807|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231808|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231809|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231810|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231811|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231812|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231813|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231814|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231815|NCT01270958|E1|Reported Event|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
231816|NCT01270919|B1|Baseline|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device
BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.
The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
231834|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
231835|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
231836|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
231817|NCT01270919|P1|Participant Flow|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device
BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.
The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
231818|NCT01270919|O1|Outcome|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device
BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.
The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
231819|NCT01270919|O1|Outcome|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device
BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.
The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
231820|NCT01270919|E1|Reported Event|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device
BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.
The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
231821|NCT01270880|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies"
231822|NCT01270880|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies"
231823|NCT01270880|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies"
231824|NCT01270880|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Hsp90 inhibitor STA-9090: Given IV
laboratory biomarker analysis: Correlative studies
polymerase chain reaction: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
RNA analysis: Correlative studies
spectrophotometry: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
gene expression analysis: Correlative studies"
231825|NCT01270867|B3|Baseline|Total|Total of all reporting groups
231826|NCT01270867|B2|Baseline|Trevo Stentriever|Patients who were randomized to the Trevo Stentriever
231827|NCT01270867|B1|Baseline|Merci Retriever|Patients who were randomized to the Merci Retriever
231828|NCT01270867|P2|Participant Flow|Trevo Stentriever|Patients who were randomized to the Trevo Stentriever
231829|NCT01270867|P1|Participant Flow|Merci Retriever|Patients who were randomized to the Merci Retriever
231830|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
231831|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
231832|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
231833|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
231838|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
231839|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
231840|NCT01270867|E2|Reported Event|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
231841|NCT01270867|E1|Reported Event|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
231842|NCT01270841|B5|Baseline|Total|Total of all reporting groups
231843|NCT01270841|B4|Baseline|Androxal 25 mg|"Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231844|NCT01270841|B3|Baseline|Androxal 12.5 mg|"Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231845|NCT01270841|B2|Baseline|Testim (Topical Testosterone)|"Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months"
231846|NCT01270841|B1|Baseline|Placebo|"Placebo
Placebo: Placebo capsule 1x daily for 3 months"
231847|NCT01270841|P4|Participant Flow|Androxal 25 mg|"Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231848|NCT01270841|P3|Participant Flow|Androxal 12.5 mg|"Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231849|NCT01270841|P2|Participant Flow|Testim (Topical Testosterone)|"Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months"
231850|NCT01270841|P1|Participant Flow|Placebo|"Placebo
Placebo: Placebo capsule 1x daily for 3 months"
231851|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231852|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231853|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months"
231854|NCT01270841|O1|Outcome|Placebo|"Placebo
Placebo: Placebo capsule 1x daily for 3 months"
231855|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231856|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231857|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months"
231858|NCT01270841|O1|Outcome|Placebo|"Placebo
Placebo: Placebo capsule 1x daily for 3 months"
231859|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231860|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231861|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months"
231862|NCT01270841|O1|Outcome|Placebo|"Placebo
Placebo: Placebo capsule 1x daily for 3 months"
231863|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231864|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231865|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months"
231866|NCT01270841|O1|Outcome|Placebo|"Placebo
Placebo: Placebo capsule 1x daily for 3 months"
231867|NCT01270841|E4|Reported Event|Androxal 25 mg|"Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231868|NCT01270841|E3|Reported Event|Androxal 12.5 mg|"Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
231869|NCT01270841|E2|Reported Event|Testim (Topical Testosterone)|"Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months"
231870|NCT01270841|E1|Reported Event|Placebo|"Placebo
Placebo: Placebo capsule 1x daily for 3 months"
231871|NCT01270828|B3|Baseline|Total|Total of all reporting groups
231872|NCT01270828|B2|Baseline|Placebo DB|Participants received matching placebo
231873|NCT01270828|B1|Baseline|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231874|NCT01270828|P3|Participant Flow|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
231875|NCT01270828|P2|Participant Flow|Placebo DB|Participants received matching placebo
231876|NCT01270828|P1|Participant Flow|Pregabalin Controlled Release (CR) DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231877|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231878|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231879|NCT01270828|O3|Outcome|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
231880|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
232130|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
232131|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
231881|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231882|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231883|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231884|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231885|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231886|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231887|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231888|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231889|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231890|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231891|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231892|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231893|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231894|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231895|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231896|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231897|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231898|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231899|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231900|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231901|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231902|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231903|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231904|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231905|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231906|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231907|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231908|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231909|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231910|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
231911|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231912|NCT01270828|E3|Reported Event|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
231913|NCT01270828|E2|Reported Event|Placebo DB|Participants received matching placebo
231914|NCT01270828|E1|Reported Event|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
231915|NCT01270802|B3|Baseline|Total|Total of all reporting groups
231916|NCT01270802|B2|Baseline|Switch to Tenofovir/Emtricitabine/Raltegravir|"Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir
Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine"
231917|NCT01270802|B1|Baseline|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
231918|NCT01270802|P2|Participant Flow|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine/raltegravir : Tenofovir/emtricitabine/efavirenz (as Atripla one pill per day) will be switched to tenofovir/emtricitabine (as Truvada one pill per day) plus raltegravir (as Isentress) 400mg orally twice daily
231919|NCT01270802|P1|Participant Flow|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz (as Atripla) one pill per day
231920|NCT01270802|O2|Outcome|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine/efavirenz will be switched to tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
231921|NCT01270802|O1|Outcome|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
231922|NCT01270802|O2|Outcome|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
231923|NCT01270802|O1|Outcome|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
231924|NCT01270802|E2|Reported Event|Switch to Tenofovir/Emtricitabine/Raltegravir|"Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir
Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine"
231925|NCT01270802|E1|Reported Event|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
231926|NCT01270711|B9|Baseline|Total|Total of all reporting groups
231927|NCT01270711|B8|Baseline|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
231928|NCT01270711|B7|Baseline|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
231929|NCT01270711|B6|Baseline|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
231930|NCT01270711|B5|Baseline|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231931|NCT01270711|B4|Baseline|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
231932|NCT01270711|B3|Baseline|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
231933|NCT01270711|B2|Baseline|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231934|NCT01270711|B1|Baseline|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231935|NCT01270711|P8|Participant Flow|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
231936|NCT01270711|P7|Participant Flow|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
231937|NCT01270711|P6|Participant Flow|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
231938|NCT01270711|P5|Participant Flow|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
233395|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
231939|NCT01270711|P4|Participant Flow|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
231940|NCT01270711|P3|Participant Flow|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
231941|NCT01270711|P2|Participant Flow|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231942|NCT01270711|P1|Participant Flow|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231943|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
231944|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
231945|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
231946|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
231947|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
231948|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
231949|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
231950|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
231951|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
231952|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231953|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
231954|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
231955|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231956|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231957|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231958|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
231959|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
233396|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
231960|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231961|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231962|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231963|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
231964|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
231965|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231966|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231967|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231968|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
231969|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
231970|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231971|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231972|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231973|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
231974|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
231975|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231976|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231977|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
232132|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
232133|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
248742|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
231978|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
231979|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
231980|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231981|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231982|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231983|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231984|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231985|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231986|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231987|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231988|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231989|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231990|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231991|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231992|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231993|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
231994|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231995|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231996|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
232134|NCT01270555|E1|Reported Event|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
248743|NCT01222520|O2|Outcome|Telmisartan|
231997|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
231998|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
231999|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
232000|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
232001|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
232002|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
232003|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
232004|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
232005|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
232006|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
232007|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
232008|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
232009|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
232010|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
232011|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
232012|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
232013|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
232014|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
232135|NCT01270542|B3|Baseline|Total|Total of all reporting groups
232136|NCT01270542|B2|Baseline|Sham Injection Group (SIG)|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
232015|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
232016|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
232017|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
232018|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
232019|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
232020|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
232021|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
232022|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
232023|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
232024|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
232025|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
232026|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
232027|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
232028|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
232029|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
232030|NCT01270711|E8|Reported Event|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
232031|NCT01270711|E7|Reported Event|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
232032|NCT01270711|E6|Reported Event|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
232033|NCT01270711|E5|Reported Event|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
232205|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
248744|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
232034|NCT01270711|E4|Reported Event|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
232035|NCT01270711|E3|Reported Event|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
232036|NCT01270711|E2|Reported Event|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
232037|NCT01270711|E1|Reported Event|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
232038|NCT01270659|B5|Baseline|Total|Total of all reporting groups
232039|NCT01270659|B4|Baseline|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo
oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
232040|NCT01270659|B3|Baseline|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
232041|NCT01270659|B2|Baseline|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once"
232042|NCT01270659|B1|Baseline|Low-FBT|"Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once"
232043|NCT01270659|P4|Participant Flow|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo
oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
232044|NCT01270659|P3|Participant Flow|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
232045|NCT01270659|P2|Participant Flow|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once"
232046|NCT01270659|P1|Participant Flow|Low-FBT|"Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once"
232047|NCT01270659|O4|Outcome|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo
oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
232048|NCT01270659|O3|Outcome|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
232049|NCT01270659|O2|Outcome|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once"
232050|NCT01270659|O1|Outcome|Low-FBT|"Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once"
232051|NCT01270659|O4|Outcome|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo
oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
232052|NCT01270659|O3|Outcome|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
232053|NCT01270659|O2|Outcome|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once"
232054|NCT01270659|O1|Outcome|Low-FBT|"Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once"
232055|NCT01270659|O4|Outcome|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo
oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
232056|NCT01270659|O3|Outcome|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
232057|NCT01270659|O2|Outcome|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once"
232058|NCT01270659|O1|Outcome|Low-FBT|"Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once"
232059|NCT01270659|E4|Reported Event|High Control|"Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo
oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time"
232060|NCT01270659|E3|Reported Event|Low Control|"Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once"
232061|NCT01270659|E2|Reported Event|High-FBT|"Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once"
232062|NCT01270659|E1|Reported Event|Low-FBT|"Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once"
232063|NCT01270620|B3|Baseline|Total|Total of all reporting groups
232064|NCT01270620|B2|Baseline|Propofol|"Patients received propofol or desflurane as general anesthetic for total knee replacement.
Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III"
232065|NCT01270620|B1|Baseline|Desflurane|"Patients received propofol or desflurane as general anesthetic for total knee replacement.
Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III"
233397|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
232066|NCT01270620|P2|Participant Flow|Propofol Group|"Patients will receive propofol as general anesthetic Propofol is an intravenous agent which will be provided continuously via IV in doses varying from 100 to 200 mcg/kg/min according to BIS monitoring.
Propofol: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
232067|NCT01270620|P1|Participant Flow|Desflurane Group|"Patients will receive desflurane as general anesthetic. Desflurane is inhaled agent which will be provided continuously via ETT in concentrations varying from 4-6% according to BIS monitoring.
Desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
232068|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
232069|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
232070|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
232071|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
232072|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
232073|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
232074|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
232075|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
232076|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
232077|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
232078|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
232079|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
232080|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
232081|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
232082|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
232083|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
232084|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
232085|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
232086|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
232087|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
232088|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
232089|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
232090|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
232091|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
232092|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
232093|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
232094|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
232095|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
232096|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
232097|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
232098|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
232099|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
232100|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
232101|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
232102|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
232103|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
232104|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
232105|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
232106|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
232107|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
232108|NCT01270620|O2|Outcome|Propofol|Patients received propofol as general anesthetic
232109|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as general anesthetic
232110|NCT01270620|O2|Outcome|Propofol|Patients received propofol as general anesthetic
232111|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as general anesthetic
232112|NCT01270620|O2|Outcome|Propofol|"Patients received propofol as general anesthetic
propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
232113|NCT01270620|O1|Outcome|Desflurane|"Patients received desflurane as general anesthetic
propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
232114|NCT01270620|E2|Reported Event|Propofol|"Patients will receive propofol as general anesthetic
propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
232115|NCT01270620|E1|Reported Event|Desflurane|"Patients will receive desflurane as general anesthetic
propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
232116|NCT01270581|B3|Baseline|Total|Total of all reporting groups
232137|NCT01270542|B1|Baseline|Avastin Injection Group (AIG)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
232138|NCT01270542|P2|Participant Flow|Sham Injection Group (SIG)|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
233398|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
232117|NCT01270581|B2|Baseline|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
232118|NCT01270581|B1|Baseline|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
232119|NCT01270581|P2|Participant Flow|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
232120|NCT01270581|P1|Participant Flow|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
232121|NCT01270581|O2|Outcome|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
232122|NCT01270581|O1|Outcome|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
232123|NCT01270581|E2|Reported Event|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
232124|NCT01270581|E1|Reported Event|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
232125|NCT01270555|B1|Baseline|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
232126|NCT01270555|P1|Participant Flow|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
232127|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
232128|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
232129|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
248745|NCT01222520|O2|Outcome|Telmisartan|
232139|NCT01270542|P1|Participant Flow|Avastin Injection Group (AIG)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
232140|NCT01270542|O2|Outcome|Sham Injection|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
232141|NCT01270542|O1|Outcome|Avastin (Bevacizumab)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
232142|NCT01270542|O2|Outcome|Sham Injection|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
232143|NCT01270542|O1|Outcome|Avastin (Bevacizumab)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
232144|NCT01270542|O2|Outcome|Sham Injection|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
232145|NCT01270542|O1|Outcome|Avastin (Bevacizumab)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
232146|NCT01270542|E2|Reported Event|Sham Injection Group (SIG)|Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
232147|NCT01270542|E1|Reported Event|Avastin Injection Group (AIG)|Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
232148|NCT01270529|B4|Baseline|Total|Total of all reporting groups
232149|NCT01270529|B3|Baseline|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232150|NCT01270529|B2|Baseline|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232151|NCT01270529|B1|Baseline|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232152|NCT01270529|P3|Participant Flow|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232153|NCT01270529|P2|Participant Flow|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232154|NCT01270529|P1|Participant Flow|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232155|NCT01270529|O3|Outcome|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232156|NCT01270529|O2|Outcome|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232157|NCT01270529|O1|Outcome|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232158|NCT01270529|E3|Reported Event|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232159|NCT01270529|E2|Reported Event|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232160|NCT01270529|E1|Reported Event|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
232161|NCT01270503|B1|Baseline|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
232162|NCT01270503|P1|Participant Flow|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
232163|NCT01270503|O1|Outcome|Menactra® Vaccine Group|Participants received a single dose of Menactra vaccine
232164|NCT01270503|O1|Outcome|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
232165|NCT01270503|E1|Reported Event|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
232166|NCT01270464|B4|Baseline|Total|Total of all reporting groups
232167|NCT01270464|B3|Baseline|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232168|NCT01270464|B2|Baseline|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232169|NCT01270464|B1|Baseline|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232170|NCT01270464|P3|Participant Flow|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232171|NCT01270464|P2|Participant Flow|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232172|NCT01270464|P1|Participant Flow|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232173|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232174|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232175|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232176|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232177|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232178|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232179|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232180|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232181|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232182|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232183|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232184|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232185|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232186|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232187|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232188|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232189|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232190|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232191|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232192|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232193|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232194|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232195|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232196|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232197|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232198|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232199|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232200|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232201|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232202|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232203|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232204|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232206|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232207|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232208|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232209|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232210|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232211|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232212|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232213|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232214|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232215|NCT01270464|E3|Reported Event|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232216|NCT01270464|E2|Reported Event|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
232217|NCT01270464|E1|Reported Event|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
232218|NCT01270256|B3|Baseline|Total|Total of all reporting groups
232219|NCT01270256|B2|Baseline|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
232220|NCT01270256|B1|Baseline|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
232221|NCT01270256|P2|Participant Flow|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
232222|NCT01270256|P1|Participant Flow|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
232223|NCT01270256|O2|Outcome|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
232224|NCT01270256|O1|Outcome|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
232225|NCT01270256|E2|Reported Event|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
232226|NCT01270256|E1|Reported Event|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
232227|NCT01270139|B4|Baseline|Total|Total of all reporting groups
232228|NCT01270139|B3|Baseline|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232229|NCT01270139|B2|Baseline|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogeneic stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232230|NCT01270139|B1|Baseline|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogeneic stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232231|NCT01270139|P3|Participant Flow|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232283|NCT01269918|B2|Baseline|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232284|NCT01269918|B1|Baseline|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232232|NCT01270139|P2|Participant Flow|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogeneic stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232233|NCT01270139|P1|Participant Flow|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogeneic stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232234|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232235|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232236|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232237|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232238|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232285|NCT01269918|P2|Participant Flow|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232286|NCT01269918|P1|Participant Flow|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232378|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
232239|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232240|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232241|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232242|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232243|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232244|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232245|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232287|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232288|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232290|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232246|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232247|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232248|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232249|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232250|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232251|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232252|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232267|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232253|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232254|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232255|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232256|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232257|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232258|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232259|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232280|NCT01270126|E2|Reported Event|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
232289|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232372|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
232260|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232261|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232262|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232263|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232264|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232265|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232266|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232281|NCT01270126|E1|Reported Event|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)
Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
232282|NCT01269918|B3|Baseline|Total|Total of all reporting groups
232373|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
248746|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
232268|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232269|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232270|NCT01270139|E3|Reported Event|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
232271|NCT01270139|E2|Reported Event|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
232272|NCT01270139|E1|Reported Event|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
232273|NCT01270126|B3|Baseline|Total|Total of all reporting groups
232274|NCT01270126|B2|Baseline|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
232275|NCT01270126|B1|Baseline|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)
Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
232276|NCT01270126|P2|Participant Flow|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
232277|NCT01270126|P1|Participant Flow|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)
Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
232278|NCT01270126|O2|Outcome|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
232279|NCT01270126|O1|Outcome|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)
Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
248747|NCT01222520|E2|Reported Event|Telmisartan|
232291|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232292|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232293|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232294|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232295|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232296|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232297|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232298|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232299|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232300|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232301|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232302|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232303|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232304|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232305|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232306|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232307|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232308|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232309|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232310|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232311|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232312|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232313|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232314|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232315|NCT01269918|E2|Reported Event|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
232316|NCT01269918|E1|Reported Event|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
232317|NCT01269801|B3|Baseline|Total|Total of all reporting groups
232318|NCT01269801|B2|Baseline|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.
At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
232319|NCT01269801|B1|Baseline|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.
At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
232320|NCT01269801|P2|Participant Flow|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.
At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
232321|NCT01269801|P1|Participant Flow|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.
At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
232322|NCT01269801|O2|Outcome|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.
At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
232323|NCT01269801|O1|Outcome|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.
At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
232324|NCT01269801|E2|Reported Event|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.
At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
232325|NCT01269801|E1|Reported Event|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.
At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
232326|NCT01269736|B3|Baseline|Total|Total of all reporting groups
232327|NCT01269736|B2|Baseline|Patients|Patients on participating units on whom quality of care data was obtained.
232328|NCT01269736|B1|Baseline|Nurses|Nurses on participating units who received education at the time hospital assigned to the standard training or online ECG education training.
232329|NCT01269736|P2|Participant Flow|Standard Care Then Online ECG Monitoring|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
232330|NCT01269736|P1|Participant Flow|Online ECG Education|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
232331|NCT01269736|O2|Outcome|Standard Care Then Online ECG Monitoring|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
232332|NCT01269736|O1|Outcome|Online ECG Education|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
232333|NCT01269736|O2|Outcome|Standard Care Then Online ECG Monitoring|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
232334|NCT01269736|O1|Outcome|Online ECG Education|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
232335|NCT01269736|O2|Outcome|Standard Care Then Online ECG Monitoring|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
248748|NCT01222520|E1|Reported Event|Telmisartan and Amlodipine FDC|
232336|NCT01269736|O1|Outcome|Online ECG Education|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart.
232337|NCT01269736|E4|Reported Event|Standard Care Then Online ECG Monitoring- Quality of Care|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. Patient Quality of Care groups.
232338|NCT01269736|E3|Reported Event|Online ECG Education- Quality of Care|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Quality of Care groups.
232339|NCT01269736|E2|Reported Event|Standard Care Then Online ECG Monitoring- Patient Outcomes|Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Outcomes groups.
232340|NCT01269736|E1|Reported Event|Online ECG Education- Patient Outcomes|The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Outcomes groups.
232341|NCT01269710|B1|Baseline|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
232342|NCT01269710|P1|Participant Flow|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
232343|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
232344|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
232345|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
232346|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
232374|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
232375|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
232376|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
232377|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
232347|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
232348|NCT01269710|E1|Reported Event|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
232349|NCT01269346|B1|Baseline|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
232350|NCT01269346|P1|Participant Flow|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
Trastuzumab 8 mg/kg was administered as an IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
232351|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
232352|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
232353|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
232354|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
232355|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
232356|NCT01269346|E1|Reported Event|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
232357|NCT01269125|B4|Baseline|Total|Total of all reporting groups
232358|NCT01269125|B3|Baseline|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
232359|NCT01269125|B2|Baseline|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
232360|NCT01269125|B1|Baseline|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
232361|NCT01269125|P3|Participant Flow|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
232362|NCT01269125|P2|Participant Flow|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
232363|NCT01269125|P1|Participant Flow|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
232364|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
232365|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
232366|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
232367|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
232368|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
232369|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
232370|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
232371|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
232379|NCT01269125|E3|Reported Event|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
232380|NCT01269125|E2|Reported Event|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
232381|NCT01269125|E1|Reported Event|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
232382|NCT01268943|B5|Baseline|Total|Total of all reporting groups
232383|NCT01268943|B4|Baseline|1500mg|capecitabine 750mg/m2 twice daily. 6 patients enrolled
232384|NCT01268943|B3|Baseline|1400mg|capecitabine 700mg/m2 twice daily. 3 patients enrolled
232385|NCT01268943|B2|Baseline|1200mg|capecitabine 600mg/m2 twice daily. 3 patients enrolled
232386|NCT01268943|B1|Baseline|1000mg|capecitabine 500mg/m2 twice daily. 6 patients enrolled
232387|NCT01268943|P4|Participant Flow|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232388|NCT01268943|P3|Participant Flow|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232389|NCT01268943|P2|Participant Flow|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232390|NCT01268943|P1|Participant Flow|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232391|NCT01268943|O4|Outcome|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232392|NCT01268943|O3|Outcome|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232393|NCT01268943|O2|Outcome|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232394|NCT01268943|O1|Outcome|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232395|NCT01268943|E4|Reported Event|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232396|NCT01268943|E3|Reported Event|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232397|NCT01268943|E2|Reported Event|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232398|NCT01268943|E1|Reported Event|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
232399|NCT01268891|B3|Baseline|Total|Total of all reporting groups
232400|NCT01268891|B2|Baseline|Azilect®|1 mg daily; tablet; orally; 18 weeks
232401|NCT01268891|B1|Baseline|Placebo|Once daily; tablet; orally; 18 weeks
232402|NCT01268891|P2|Participant Flow|Azilect®|1 mg daily; tablet; orally; 18 weeks
232403|NCT01268891|P1|Participant Flow|Placebo|Once daily; tablet; orally; 18 weeks
232404|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
232405|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
232406|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
232407|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
232408|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
232409|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
232410|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
232411|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
232412|NCT01268891|E2|Reported Event|Azilect®|
232413|NCT01268891|E1|Reported Event|Placebo|
232414|NCT01268683|B1|Baseline|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
232415|NCT01268683|P1|Participant Flow|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion; total of 3mg/day
232416|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
232417|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
232418|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
232419|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
232420|NCT01268683|E1|Reported Event|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
232421|NCT01268566|B1|Baseline|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232422|NCT01268566|P1|Participant Flow|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232475|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound
Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
232423|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232424|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232425|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232426|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232427|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232428|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232429|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232430|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232431|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232432|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232433|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232434|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232435|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232436|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232437|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232438|NCT01268566|E1|Reported Event|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
232439|NCT01268501|B1|Baseline|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
232440|NCT01268501|P1|Participant Flow|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
232441|NCT01268501|O1|Outcome|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
232442|NCT01268501|E1|Reported Event|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
232443|NCT01268488|B1|Baseline|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
232444|NCT01268488|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
232445|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
232476|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound
Control dressing: Xeroform control dressing applied to control wound"
232446|NCT01268488|O1|Outcome|Intended Users of the System|Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
232447|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
232448|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
232449|NCT01268488|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
232450|NCT01268306|B1|Baseline|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
232451|NCT01268306|P1|Participant Flow|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
232452|NCT01268306|O1|Outcome|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
232453|NCT01268306|E1|Reported Event|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
232454|NCT01268293|B1|Baseline|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
232455|NCT01268293|P1|Participant Flow|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
232456|NCT01268293|O1|Outcome|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
232457|NCT01268293|O1|Outcome|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
232458|NCT01268293|E1|Reported Event|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
232459|NCT01268267|B1|Baseline|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
232460|NCT01268267|P1|Participant Flow|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
232461|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
232462|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
232463|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
232464|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject were evaluated.
232465|NCT01268267|E1|Reported Event|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
232466|NCT01268189|B1|Baseline|Burn Wound Patients|Burn wound patients with oxygen diffusing dressing placed on 1 donor skin graft site and standard of care (Xeroform) dressing placed on a 2nd donor skin graft
232467|NCT01268189|P1|Participant Flow|Burn Wound Patients|Burn wound patients with experimental (oxyband) and control (Xeroform) dressings placed on 2 separate skin graft donor sites
232468|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound
Control dressing: Xeroform control dressing applied to control wound"
232469|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound
Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
232470|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound
Control dressing: Xeroform control dressing applied to control wound"
232471|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound
Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
232472|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound
Control dressing: Xeroform control dressing applied to control wound"
232473|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound
Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
232474|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound
Control dressing: Xeroform control dressing applied to control wound"
232477|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound
Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
232478|NCT01268189|E2|Reported Event|Control Dressing|"Xeroform (current standard of care) dressing applied to wound
Control dressing: Xeroform control dressing applied to control wound"
232479|NCT01268189|E1|Reported Event|Study Dressing|"Oxygen diffusing dressing applied to wound
Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
232480|NCT01268150|B1|Baseline|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
232481|NCT01268150|P1|Participant Flow|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
232482|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
232483|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
232484|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
232485|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
232486|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
232487|NCT01268150|E1|Reported Event|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
232488|NCT01268111|B3|Baseline|Total|Total of all reporting groups
232489|NCT01268111|B2|Baseline|Placebo|Matching placebo q weekly for 8 weeks
232490|NCT01268111|B1|Baseline|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
232491|NCT01268111|P2|Participant Flow|Placebo|Matching placebo q weekly for 8 weeks
232492|NCT01268111|P1|Participant Flow|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
232493|NCT01268111|O2|Outcome|Placebo|Matching placebo q weekly for 8 weeks
232494|NCT01268111|O1|Outcome|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
232495|NCT01268111|E2|Reported Event|Placebo|Matching placebo q weekly for 8 weeks
232496|NCT01268111|E1|Reported Event|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
232497|NCT01268098|B3|Baseline|Total|Total of all reporting groups
232498|NCT01268098|B2|Baseline|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
232499|NCT01268098|B1|Baseline|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
232500|NCT01268098|P2|Participant Flow|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily.
232501|NCT01268098|P1|Participant Flow|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily.
232502|NCT01268098|O2|Outcome|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
232503|NCT01268098|O1|Outcome|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
232504|NCT01268098|O2|Outcome|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
232505|NCT01268098|O1|Outcome|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
232506|NCT01268098|E2|Reported Event|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
232507|NCT01268098|E1|Reported Event|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
232508|NCT01267994|B1|Baseline|Single Arm|Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
232509|NCT01267994|P1|Participant Flow|Open Label Trial|Open label, single arm trial of anakinra for corticosteroid-resistant Autoimmune Inner Ear Disease
232510|NCT01267994|O1|Outcome|Single Arm|Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
232511|NCT01267994|E1|Reported Event|Single Arm|Anakinra administered for 84 consecutive days
232512|NCT01267929|B3|Baseline|Total|Total of all reporting groups
232513|NCT01267929|B2|Baseline|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
232514|NCT01267929|B1|Baseline|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
232515|NCT01267929|P2|Participant Flow|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
232638|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
232516|NCT01267929|P1|Participant Flow|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
232517|NCT01267929|O2|Outcome|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
232518|NCT01267929|O1|Outcome|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
232519|NCT01267929|E2|Reported Event|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
232520|NCT01267929|E1|Reported Event|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
232521|NCT01267422|B1|Baseline|All Study Participants|Age,Gender,Ethnicity,Race,Region of Enrollment
232522|NCT01267422|P2|Participant Flow|Participants Receiving Treatment in Right Eye|4 participants receiving treatment in right eye
232523|NCT01267422|P1|Participant Flow|Participants Receiving Treatment in Left Eye|5 participants receiving treatment in left eye
232524|NCT01267422|O2|Outcome|Mean VFI After Treatment|Mean VFI after treatment of injected eyes;Mean VFI after treatment of uninjected eyes
232525|NCT01267422|O1|Outcome|Mean VFI Before Treatment|Mean VFI before treatment of injected eyes;Mean VFI before treatment of uninjected eyes
232526|NCT01267422|O2|Outcome|Mean MD After Treatment|Mean MD after treatment of injected eyes;Mean MD after treatment of uninjected eyes
232527|NCT01267422|O1|Outcome|Mean MD Before Treatment|Mean MD before treatment of injected eyes;Mean MD before treatment of uninjected eyes
232528|NCT01267422|O2|Outcome|Average RNFL Thickness After Treatment|Average RNFL thickness after treatment of injected eyes;Average RNFL thickness after treatment of uninjected eyes
232529|NCT01267422|O1|Outcome|Average RNFL Thickness Before Treatment|Average RNFL thickness before treatment of injected eyes;Average RNFL thickness before treatment of uninjected eyes
232530|NCT01267422|O2|Outcome|The Mean of Neutralizing Antibody Assay After Treatment|The mean of Neutralizing antibody assay after treatment of 8 patients
232531|NCT01267422|O1|Outcome|The Mean of Neutralizing Antibody Assay Before Treatment|The mean of Neutralizing antibody assay before treatment of 8 patients
232532|NCT01267422|O2|Outcome|IOP After Treatment|Ophthalmologic examinations includes IOP of 9 participants after treatment
232533|NCT01267422|O1|Outcome|IOP Before Treatment|Ophthalmologic examinations includes IOP of 9 paticipants before treatment
232534|NCT01267422|O2|Outcome|The Mean Percentage of CD3+/CD4+/CD8+ After Treatment|The mean percentage of CD3+ after treatment;The mean percentage of CD4+ after treatment;The mean percentage of CD8+ after treatment
232535|NCT01267422|O1|Outcome|The Mean Percentage of CD3+/CD4+/CD8+ Before Treatment|The mean percentage of CD3+ before treatment;The mean percentage of CD4+ before treatment;The mean percentage of CD8+ before treatment
232536|NCT01267422|O2|Outcome|BCVA of Treated Eyes|BCVA of trearted eyes in 9 patients
232537|NCT01267422|O1|Outcome|BCVA of Un-treated Eyes|BCVA of un-treated eyes in 9 patients
232538|NCT01267422|E2|Reported Event|Long-term Affects|Lens may be injured after intravitreal injection, and cataract is probably complicated. Retinal detachment or endophthalmitis may be complicated due to retina injury.IOP raised.Blood and urine routine is affected.Liver and kidney function is affected.Immune response after surgery.
232539|NCT01267422|E1|Reported Event|Short-term Affects|Lens may be injured during intravitreal injection, and cataract is probably complicated. Retinal detachment or endophthalmitis may be complicated due to retina injury.IOP raised.Endophthalmitis after treament. Hyper-susceptibility or immune response during surgery or after surgery.
232540|NCT01267292|B3|Baseline|Total|Total of all reporting groups
232600|NCT01267240|P1|Participant Flow|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO"
232669|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232541|NCT01267292|B2|Baseline|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232542|NCT01267292|B1|Baseline|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232543|NCT01267292|P2|Participant Flow|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232544|NCT01267292|P1|Participant Flow|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232545|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232546|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232547|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232548|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232549|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232550|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232601|NCT01267240|O1|Outcome|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO"
232773|NCT01266876|B1|Baseline|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232551|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232552|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232553|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232554|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232555|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232556|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232557|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232558|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232559|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232560|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232602|NCT01267240|O1|Outcome|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO"
232818|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232561|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232562|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232563|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232564|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232565|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232566|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232567|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232568|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232569|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232570|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232603|NCT01267240|O1|Outcome|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO"
232819|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232571|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232572|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232573|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232574|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
232575|NCT01267292|E2|Reported Event|Placebo|"week 1: Placebo BID weeks 2-3: Placebo BID
Placebo: week 1 = placebo BID weeks 2-3 = placebo BID"
232576|NCT01267292|E1|Reported Event|Buspirone|"week 1: Buspirone 30 mg BID weeks 2-3: Buspirone 45 mg BID
Buspirone: week 1 = 30 mg BID weeks 2-3 = 45 mg BID"
232577|NCT01267266|B1|Baseline|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
232578|NCT01267266|P2|Participant Flow|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
232579|NCT01267266|P1|Participant Flow|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
232580|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
232581|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
232582|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
232583|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
232584|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
232585|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
232586|NCT01267266|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.
hydrocortisone/placebo: Given orally"
232587|NCT01267266|O1|Outcome|Arm I (Saracatinib)|"Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally"
232588|NCT01267266|E3|Reported Event|Placebo, Randomized Phase|Patients receive placebo once daily on days 1-28.
232589|NCT01267266|E2|Reported Event|Saracatinib, Randomized Phase|Patients receive 175 mg oral saracatinib once daily on days 1-28.
232590|NCT01267266|E1|Reported Event|Saracatinib, Lead-in Phase|Patients receive 175 mg oral saracatinib once daily on days 1-28.
232591|NCT01267253|B1|Baseline|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
232592|NCT01267253|P1|Participant Flow|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
232593|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
232594|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
232595|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
232596|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
232597|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
232598|NCT01267253|E1|Reported Event|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
232599|NCT01267240|B1|Baseline|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO"
232604|NCT01267240|E1|Reported Event|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO"
232605|NCT01267227|B5|Baseline|Total|Total of all reporting groups
232606|NCT01267227|B4|Baseline|Placebo|Matching placebo twice daily
232607|NCT01267227|B3|Baseline|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
232608|NCT01267227|B2|Baseline|Low Dose|Pterostilbene 50 mg twice daily
232609|NCT01267227|B1|Baseline|High Dose|Pterostilbene 125 mg twice daily
232610|NCT01267227|P4|Participant Flow|Placebo|Matching placebo twice daily
232611|NCT01267227|P3|Participant Flow|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
232612|NCT01267227|P2|Participant Flow|Low Dose|Pterostilbene 50 mg twice daily
232613|NCT01267227|P1|Participant Flow|High Dose|Pterostilbene 125 mg twice daily
232614|NCT01267227|O4|Outcome|Placebo|Matching placebo twice daily
232615|NCT01267227|O3|Outcome|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
232616|NCT01267227|O2|Outcome|Low Dose|Pterostilbene 50 mg twice daily
232617|NCT01267227|O1|Outcome|High Dose|Pterostilbene 125 mg twice daily
232618|NCT01267227|O4|Outcome|Placebo|Matching placebo twice daily. Unadjusted change from baseline.
232619|NCT01267227|O3|Outcome|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
232620|NCT01267227|O2|Outcome|Low Dose|Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
232621|NCT01267227|O1|Outcome|High Dose|Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
232622|NCT01267227|E4|Reported Event|Placebo|Matching placebo twice daily
232623|NCT01267227|E3|Reported Event|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
232624|NCT01267227|E2|Reported Event|Low Dose|Pterostilbene 50 mg twice daily
232625|NCT01267227|E1|Reported Event|High Dose|Pterostilbene 125 mg twice daily
232626|NCT01267201|B1|Baseline|Entire Study Population|Includes all participants randomized to receive methylprednisolone 32 mg tablet first, formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) first and formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) first.
232627|NCT01267201|P6|Participant Flow|Methylprednisolone Formulation 2, Formulation 1, 32 mg Tablet|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
232628|NCT01267201|P5|Participant Flow|Methylprednisolone Formulation 2, 32 mg Tablet, Formulation 1|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
232629|NCT01267201|P4|Participant Flow|Methylprednisolone Formulation 1, Formulation 2, 32 mg Tablet|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
232630|NCT01267201|P3|Participant Flow|Methylprednisolone Formulation 1, 32 mg Tablet, Formulation 2|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
232631|NCT01267201|P2|Participant Flow|Methylprednisolone 32 mg Tablet, Formulation 2, Formulation 1|Single oral dose of methylprednisolone 32 mg tablet on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
232632|NCT01267201|P1|Participant Flow|Methylprednisolone 32 mg Tablet, Formulation 1, Formulation 2|Single oral dose of methylprednisolone 32 milligram (mg) tablet on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 milligram/milliliter (mg/mL) at 32 mg (Micronized active pharmaceutical ingredient [API]) on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
232633|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
232634|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
232635|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
232636|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
232637|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
233135|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
232639|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
232640|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
232641|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
232642|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
232643|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
232644|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
232645|NCT01267201|E3|Reported Event|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
232646|NCT01267201|E2|Reported Event|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
232647|NCT01267201|E1|Reported Event|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
232648|NCT01267175|B1|Baseline|X54 Pump|All subjects transferred from current pump to X54
232649|NCT01267175|P1|Participant Flow|X54 Pump|All subjects transferred from current pump to X54
232650|NCT01267175|O1|Outcome|X54 Pump|All subjects transferred from current pump to X54
232651|NCT01267175|O1|Outcome|X54 Pump|All subjects transferred from current pump to X54
232652|NCT01267175|E1|Reported Event|X54 Pump|All subjects transferred from current pump to X54
232653|NCT01267136|B3|Baseline|Total|Total of all reporting groups
232654|NCT01267136|B2|Baseline|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
232655|NCT01267136|B1|Baseline|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
232656|NCT01267136|P2|Participant Flow|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day).
232657|NCT01267136|P1|Participant Flow|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day)
232658|NCT01267136|O2|Outcome|Tramadol Suspension|Tramadol suspension: Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
232659|NCT01267136|O1|Outcome|Capital® With Codeine Suspension|Codeine with acetaminophen: Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
232660|NCT01267136|O2|Outcome|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
232661|NCT01267136|O1|Outcome|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
232662|NCT01267136|E2|Reported Event|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
232663|NCT01267136|E1|Reported Event|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
232664|NCT01267045|B3|Baseline|Total|Total of all reporting groups
232665|NCT01267045|B2|Baseline|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232666|NCT01267045|B1|Baseline|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in Mindfulness-Based Stress Reduction.
Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232667|NCT01267045|P2|Participant Flow|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232668|NCT01267045|P1|Participant Flow|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction.
Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a class series called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232670|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232671|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232672|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232673|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232674|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232675|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232676|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232677|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232678|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232679|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232680|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232681|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232720|NCT01266967|B1|Baseline|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 milligram (mg) capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232721|NCT01266967|P2|Participant Flow|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232774|NCT01266876|P5|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
249327|NCT01221311|B3|Baseline|Total|Total of all reporting groups
232682|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232683|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232684|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232685|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232686|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232687|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232688|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232689|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232690|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232691|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232692|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232693|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232722|NCT01266967|P1|Participant Flow|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 milligram (mg) capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232723|NCT01266967|O2|Outcome|ThxID BRAF Mutation Positive Participants|Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the ThxID assay. The RGI test was further validated by BioMerieux (BMX THxID assay) for regulatory approval. The THxID IUO assay was used to retrospectively confirm the RGI test results.
232775|NCT01266876|P4|Participant Flow|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232694|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can b"
232695|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232696|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
232697|NCT01267045|E2|Reported Event|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
232698|NCT01267045|E1|Reported Event|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course.
The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can b"
232699|NCT01267019|B4|Baseline|Total|Total of all reporting groups
232700|NCT01267019|B3|Baseline|Arm 3: Non-social Skills|"non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content"
232701|NCT01267019|B2|Baseline|Arm 2: Social Cognitive|"social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
232702|NCT01267019|B1|Baseline|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
232703|NCT01267019|P3|Participant Flow|Arm 3: Non-social Skills|"non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content"
232704|NCT01267019|P2|Participant Flow|Arm 2: Social Cognitive|"social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
232705|NCT01267019|P1|Participant Flow|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
232706|NCT01267019|O3|Outcome|Arm 3: Non-social Skills|"non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content"
232707|NCT01267019|O2|Outcome|Arm 2: Social Cognitive|"social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
232708|NCT01267019|O1|Outcome|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
232709|NCT01267019|O3|Outcome|Arm 3: Non-social Skills|"non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content"
232710|NCT01267019|O2|Outcome|Arm 2: Social Cognitive|"social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
232711|NCT01267019|O1|Outcome|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
232712|NCT01267019|O3|Outcome|Arm 3: Non-social Skills|"non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content"
232713|NCT01267019|O2|Outcome|Arm 2: Social Cognitive|"social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
232714|NCT01267019|O1|Outcome|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
232715|NCT01267019|E3|Reported Event|Arm 3: Non-social Skills|"non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content"
232716|NCT01267019|E2|Reported Event|Arm 2: Social Cognitive|"social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
232717|NCT01267019|E1|Reported Event|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
232718|NCT01266967|B3|Baseline|Total|Total of all reporting groups
232719|NCT01266967|B2|Baseline|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
251561|NCT01215292|O1|Outcome|Acyline + Testosterone Gel (Tgel)+ Placebo|
232724|NCT01266967|O1|Outcome|RGI IUO Mutation Positive Participants|Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the RGI assay. The RGI assay is a BRAF mutation test developed by Response Genetics Incorporated, and was used to determine eligibility. It employs the allele-specific polymerase chain reaction (ASPCR) methodology, and was offered as an Investigational Use Only assay (only for pre-market investigational purposes).
232725|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232726|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232727|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232728|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232729|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232730|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232731|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232732|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232733|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232734|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232735|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232736|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232737|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232738|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232739|NCT01266967|O1|Outcome|GSK2118436 150 mg|Participants with or without prior local therapy for brain metastasis received GSK2118436 50 mg and 75 mg capsules either one hour before or 2 hours after a meal twice daily.
232740|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232741|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232742|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232743|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232744|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232745|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232746|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
233136|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
232747|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232748|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232749|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232750|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232751|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232752|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232753|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232754|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232755|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232756|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232757|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232758|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232759|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232760|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232761|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232762|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232763|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232764|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232765|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232766|NCT01266967|E2|Reported Event|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232767|NCT01266967|E1|Reported Event|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
232768|NCT01266876|B6|Baseline|Total|Total of all reporting groups
232769|NCT01266876|B5|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232770|NCT01266876|B4|Baseline|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232771|NCT01266876|B3|Baseline|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232772|NCT01266876|B2|Baseline|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232776|NCT01266876|P3|Participant Flow|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232777|NCT01266876|P2|Participant Flow|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection once every 4 weeks (Q4W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232778|NCT01266876|P1|Participant Flow|Placebo|Placebo subcutaneous (SC) injection once every two weeks (Q2W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232779|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232780|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232781|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232782|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232783|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232784|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232785|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232786|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232787|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232788|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232789|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232790|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232791|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232792|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232793|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232794|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232795|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232796|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232797|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232798|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232799|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232800|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232801|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232802|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232803|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232804|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232805|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232806|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232807|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232808|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232809|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232810|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232811|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232812|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232813|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232814|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232815|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232816|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232817|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232820|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232821|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232822|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232823|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232824|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232825|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232826|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232827|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232828|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232829|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232830|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232831|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232832|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232833|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232834|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232835|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232836|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232837|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232838|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232839|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232840|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232841|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232842|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232843|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232844|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232845|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232846|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232847|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232848|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232849|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232850|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232851|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232852|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232853|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232854|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232855|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232856|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232857|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232858|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232859|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232860|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232861|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
253063|NCT01212094|O1|Outcome|Placebo|Group administered placebo
232862|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232863|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232864|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232865|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232866|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232867|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232868|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232869|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232870|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232871|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232872|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232873|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232874|NCT01266876|E5|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232875|NCT01266876|E4|Reported Event|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232876|NCT01266876|E3|Reported Event|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232877|NCT01266876|E2|Reported Event|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232878|NCT01266876|E1|Reported Event|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
232879|NCT01266850|B6|Baseline|Total|Total of all reporting groups
232880|NCT01266850|B5|Baseline|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received 2-mL Rotarix® orally at 2 months of age, followed by 1-mL RotaTeq® orally at 4 and 6 months of age.
232881|NCT01266850|B4|Baseline|Group 4: Rotarix, Rotarix|Participants received 2-mL Rotarix® orally at 2 and 4 months of age.
232882|NCT01266850|B3|Baseline|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received 2-mL RotaTeq® orally at 2 and 4 months of age, followed by 1-mL Rotarix® orally at 6 months of age.
232883|NCT01266850|B2|Baseline|Group 2: RotaTeq, Rotarix, Rotarix|Participants received 2-mL RotaTeq® orally at 2 months of age, followed by 1-mL Rotarix® orally at 4 and 6 months of age.
232884|NCT01266850|B1|Baseline|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received 2-mL RotaTeq® orally at 2, 4 and 6 months of age.
232885|NCT01266850|P5|Participant Flow|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
232886|NCT01266850|P4|Participant Flow|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
232887|NCT01266850|P3|Participant Flow|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
232888|NCT01266850|P2|Participant Flow|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
232889|NCT01266850|P1|Participant Flow|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
232890|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
232891|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
232892|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
232893|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
232894|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
232895|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
232896|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
232897|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
232898|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
232899|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
232900|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
232901|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
232902|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
232903|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
232904|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
232905|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
232906|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
232907|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
232908|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
232909|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
232910|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
232911|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
232912|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
232913|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
232914|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
232915|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
232916|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
232917|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
232918|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
232919|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
232920|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
232921|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
232922|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
232923|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
232924|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
232925|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
232926|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
232927|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
232928|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
232929|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
232930|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
232931|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
232932|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
232933|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
232934|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
232935|NCT01266850|E5|Reported Event|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
232936|NCT01266850|E4|Reported Event|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
232937|NCT01266850|E3|Reported Event|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
232938|NCT01266850|E2|Reported Event|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
232939|NCT01266850|E1|Reported Event|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
232940|NCT01266824|B3|Baseline|Total|Total of all reporting groups
232941|NCT01266824|B2|Baseline|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
232942|NCT01266824|B1|Baseline|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops
Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
232943|NCT01266824|P2|Participant Flow|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
232944|NCT01266824|P1|Participant Flow|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops
Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
232945|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
232991|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
233137|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
232946|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops
Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
232947|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
232948|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops
Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
232949|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
232950|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops
Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
232951|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
232952|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops
Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
232953|NCT01266824|E2|Reported Event|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
232954|NCT01266824|E1|Reported Event|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops
Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
232955|NCT01266447|B1|Baseline|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
232956|NCT01266447|P1|Participant Flow|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
232957|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
232958|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
232959|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
232960|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
232961|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
232962|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
232963|NCT01266447|E1|Reported Event|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
232964|NCT01266291|B1|Baseline|Treatment With Sabril (Vigabatrin)|This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased by 1 gm/week for one month under the supervision of the study doctor.
232992|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
232993|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
232994|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
232965|NCT01266291|P1|Participant Flow|Treatment With Sabril (Vigabatrin)|"The interventional arm of this phase 4 study involved subjects taking vigabatrin (Sabril) in accordance with standard of care, FDA approved dosing instructions. There were no planned arms; all subjects followed the FDA-approved prescribing label.
As there were not multiple treatment arms under investigation, per the FDA-approved prescribing label, the one and only subject who enrolled underwent upward titration happened at a rate of 500mg per week until she reached her maximum tolerated dose, or 3g per day. This dose was decreased as needed under the supervision of the study doctor. Again in accordance with standard of care, FDA-approved prescribing guidelines, when she stopped taking Sabril, her dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor."
232966|NCT01266291|O1|Outcome|Treatment With Sabril (Vigabatrin)|This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
232967|NCT01266291|O1|Outcome|Treatment With Sabril (Vigabatrin)|This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
232968|NCT01266291|E1|Reported Event|Treatment With Sabril (Vigabatrin)|This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
232969|NCT01266265|B3|Baseline|Total|Total of all reporting groups
232970|NCT01266265|B2|Baseline|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
232971|NCT01266265|B1|Baseline|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: Tyvaso"
232972|NCT01266265|P2|Participant Flow|Control|"The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of Baseline visit, but treated with any other FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: As prescribed by the physician prostacyclin: As prescribed by the physician subcutaneous and intravenous prostacyclin: As prescribed by physician oral ERA: As prescribed by physician oral PDE5 inhibitors: As prescribed by physician"
232973|NCT01266265|P1|Participant Flow|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: Tyvaso"
232974|NCT01266265|O2|Outcome|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
232975|NCT01266265|O1|Outcome|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: Tyvaso"
232976|NCT01266265|E2|Reported Event|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
232977|NCT01266265|E1|Reported Event|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: Tyvaso"
232978|NCT01266148|B3|Baseline|Total|Total of all reporting groups
232979|NCT01266148|B2|Baseline|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
232980|NCT01266148|B1|Baseline|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
232981|NCT01266148|P2|Participant Flow|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
232982|NCT01266148|P1|Participant Flow|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
232983|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
232984|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
232985|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
232986|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
232987|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
232988|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
232989|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
232990|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
232995|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
232996|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
232997|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
232998|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
232999|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
233000|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
233001|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
233002|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
233003|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
233004|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
233005|NCT01266148|E2|Reported Event|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
233006|NCT01266148|E1|Reported Event|Controls|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study
233007|NCT01266122|B3|Baseline|Total|Total of all reporting groups
233008|NCT01266122|B2|Baseline|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.
Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
233009|NCT01266122|B1|Baseline|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
233010|NCT01266122|P2|Participant Flow|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.
Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
233011|NCT01266122|P1|Participant Flow|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
233012|NCT01266122|O2|Outcome|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.
Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
233013|NCT01266122|O1|Outcome|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
233014|NCT01266122|O2|Outcome|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.
Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
233015|NCT01266122|O1|Outcome|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
233016|NCT01266122|E2|Reported Event|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.
Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
233017|NCT01266122|E1|Reported Event|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
233018|NCT01266070|B1|Baseline|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
233019|NCT01266070|P1|Participant Flow|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
233020|NCT01266070|O1|Outcome|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
233021|NCT01266070|O1|Outcome|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
233022|NCT01266070|E1|Reported Event|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
233023|NCT01266031|B4|Baseline|Total|Total of all reporting groups
233024|NCT01266031|B3|Baseline|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
233025|NCT01266031|B2|Baseline|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
233026|NCT01266031|B1|Baseline|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle.
233027|NCT01266031|P3|Participant Flow|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
233028|NCT01266031|P2|Participant Flow|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
233399|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233029|NCT01266031|P1|Participant Flow|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
233030|NCT01266031|O1|Outcome|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
233031|NCT01266031|O2|Outcome|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
233032|NCT01266031|O1|Outcome|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
233033|NCT01266031|E3|Reported Event|Phase II: Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
233034|NCT01266031|E2|Reported Event|Phase II: Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
233035|NCT01266031|E1|Reported Event|Phase I: Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
233036|NCT01266018|B1|Baseline|All Enrolled Subjects|Includes all subjects enrolled in Cohort 1 (n = 9) and Cohort 2 (n = 13).
233037|NCT01266018|P2|Participant Flow|Cohort 2: Refractory Disease|Cohort 2 comprised subjects with “refractory” disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response
233038|NCT01266018|P1|Participant Flow|Cohort 1: Sensitive Disease|Cohort 1 comprised subjects with “sensitive” disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
233039|NCT01266018|O2|Outcome|Cohort 2: Refractory Disease|Includes subjects with “refractory” disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.
233040|NCT01266018|O1|Outcome|Cohort 1: Sensitive Disease|Includes subjects with “sensitive” disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
233041|NCT01266018|O1|Outcome|All Subjects (Pharmacodynamic Analysis Set)|Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 12) who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses.
233042|NCT01266018|O1|Outcome|All Subjects (Pharmacodynamic Analysis Set)|Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 12) who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses.
233043|NCT01266018|O2|Outcome|Cohort 2: Refractory Disease|"Includes subjects with refractory disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response."
233044|NCT01266018|O1|Outcome|Cohort 1: Sensitive Disease|"Includes subjects with sensitive disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more."
233045|NCT01266018|O2|Outcome|Cohort 2: Refractory Disease|Includes subjects with “refractory” disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.
233046|NCT01266018|O1|Outcome|Cohort 1: Sensitive Disease|Includes subjects with “sensitive” disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
233047|NCT01266018|E1|Reported Event|All Subjects (Safety Analysis Set)|Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 13) who received at least 1 dose of study drug.
233048|NCT01265992|B1|Baseline|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233049|NCT01265992|P1|Participant Flow|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 chronic kidney disease (CKD) and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233050|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233051|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233052|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233053|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233054|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233055|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233056|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233134|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
257052|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
233057|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233058|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233059|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233060|NCT01265992|E1|Reported Event|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
233061|NCT01265966|B4|Baseline|Total|Total of all reporting groups
233062|NCT01265966|B3|Baseline|General Anesthesia|Children undergoing general anesthesia for procedures.
233063|NCT01265966|B2|Baseline|Deep Sedation|Children undergoing deep sedation for procedures.
233064|NCT01265966|B1|Baseline|Moderate Sedation|Children undergoing moderate sedation for procedures.
233065|NCT01265966|P3|Participant Flow|General Anesthesia|Children undergoing general anesthesia for procedures.
233066|NCT01265966|P2|Participant Flow|Deep Sedation|Children undergoing deep sedation for procedures.
233067|NCT01265966|P1|Participant Flow|Moderate Sedation|Children undergoing moderate sedation for procedures.
233068|NCT01265966|O3|Outcome|General Anesthesia|Children undergoing general anesthesia for procedures.
233069|NCT01265966|O2|Outcome|Deep Sedation|Children undergoing deep sedation for procedures.
233070|NCT01265966|O1|Outcome|Moderate Sedation|Children undergoing moderate sedation for procedures.
233071|NCT01265966|E3|Reported Event|General Anesthesia|Children undergoing general anesthesia for procedures.
233072|NCT01265966|E2|Reported Event|Deep Sedation|Children undergoing deep sedation for procedures.
233073|NCT01265966|E1|Reported Event|Moderate Sedation|Children undergoing moderate sedation for procedures.
233074|NCT01265953|B3|Baseline|Total|Total of all reporting groups
233075|NCT01265953|B2|Baseline|Placebo Capsules|"Four weeks placebo capsules: 8 capsules (4 capsules B.I.D.) daily
Gelatin capsule containing cellulose and magnesium stearate: Four weeks placebo: 8 capsules (4 capsules B.I.D.) daily"
233076|NCT01265953|B1|Baseline|Sulforaphane Glucosinolate Capsules|"Four weeks sulforaphane (SFN) glucosinolate capsules: 250 mg of broccoli seed extract (30 mg sulforaphane glucosinolate), 8 capsules (4 capsules B.I.D.) daily
sulforaphane glucosinolate capsules: Four weeks sulforaphane (SFN) glucosinolate capsules: 250 mg of broccoli seed extract (30 mg sulforaphane glucosinolate), 8 capsules (4 capsules B.I.D.) daily"
233077|NCT01265953|P2|Participant Flow|Placebo|Subjects in this group were administered with placebo.
233078|NCT01265953|P1|Participant Flow|Supplement|Subjects in this group were administered with broccoli sprout extract.
233079|NCT01265953|O2|Outcome|Placebo|Subjects in this group were administered with placebo.
233080|NCT01265953|O1|Outcome|Supplement|Subjects in this group were administered with broccoli sprout extract.
233081|NCT01265953|O2|Outcome|Placebo|Subjects in this group were administered with placebo.
233082|NCT01265953|O1|Outcome|Supplement|Subjects in this group were administered with broccoli sprout extract.
233083|NCT01265953|O2|Outcome|Placebo|Subjects in this group were administered with placebo.
233084|NCT01265953|O1|Outcome|Supplement|Subjects in this group were administered with broccoli sprout extract.
233085|NCT01265953|O2|Outcome|Placebo|Subjects in this group were administered with placebo.
233086|NCT01265953|O1|Outcome|Supplement|Subjects in this group were administered with broccoli sprout extract.
233087|NCT01265953|E2|Reported Event|Placebo|Subjects in this group were administered with placebo.
233088|NCT01265953|E1|Reported Event|Supplement|Subjects in this group were administered with broccoli sprout extract.
233089|NCT01265875|B1|Baseline|Human Secretin|Human Secretin : Dose Escalation
233090|NCT01265875|P1|Participant Flow|Human Secretin|"Human Secretin : Dose Escalation
There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
233091|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation
There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
233092|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation
There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
233093|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation
There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
233094|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation
There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
233095|NCT01265875|O1|Outcome|Human Secretin|Human Secretin : Dose Escalation
233096|NCT01265875|E1|Reported Event|Human Secretin|Human Secretin : Dose Escalation within participant
233097|NCT01265823|B1|Baseline|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233098|NCT01265823|P1|Participant Flow|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233099|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233100|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233101|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233102|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233103|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233104|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233105|NCT01265823|O2|Outcome|Adalimumab in Non-obese Participants|Non-obese participants were defined as those with a waist-hip ratio of ≤1 for men and ≤0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233106|NCT01265823|O1|Outcome|Adalimumab in Obese Participants|Obese participants were defined as those with a waist-hip ratio of >1 for men and >0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233107|NCT01265823|O2|Outcome|Adalimumab in Non-obese Participants|Non-obese participants were defined as having a BMI < 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233108|NCT01265823|O1|Outcome|Adalimumab in Obese Participants|Obese participants were defined as having a BMI ≥ 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233109|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233110|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233111|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233112|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233113|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233114|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233115|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233116|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233117|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233118|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233119|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233120|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233121|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233122|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233123|NCT01265823|E1|Reported Event|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
233124|NCT01265797|B3|Baseline|Total|Total of all reporting groups
233125|NCT01265797|B2|Baseline|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
233126|NCT01265797|B1|Baseline|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
233127|NCT01265797|P2|Participant Flow|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
233128|NCT01265797|P1|Participant Flow|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
233129|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
233130|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
233131|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
233132|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
233133|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
233138|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
233139|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
233140|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
233141|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
233142|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
233143|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
233144|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
233145|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
233146|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
233147|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
233148|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
233149|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
233150|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
233151|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
233152|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
233153|NCT01265797|E2|Reported Event|Sham|Sham: wears sham cranial electrostimulation (CES) device for 20 minutes daily for 28 days
233154|NCT01265797|E1|Reported Event|Verum|Verum : wears active cranial electrostimulation (CES) device for 20 minutes daily for 28 days
233155|NCT01265784|B4|Baseline|Total|Total of all reporting groups
233156|NCT01265784|B3|Baseline|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233157|NCT01265784|B2|Baseline|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233158|NCT01265784|B1|Baseline|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233159|NCT01265784|P3|Participant Flow|Ertapenem, 1 g q24h|Ertapenem was administered IV at a dose of 1 gram (g) q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233160|NCT01265784|P2|Participant Flow|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233161|NCT01265784|P1|Participant Flow|TP-434, 1.5 mg/kg q24h|TP-434 was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram of body weight (mg/kg) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233162|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233163|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233164|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233165|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233166|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233167|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233168|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233169|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233170|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233171|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233172|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233173|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233174|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233175|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233176|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233177|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233178|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233179|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233180|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233181|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233182|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233183|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233184|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233185|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233186|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233187|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233188|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233189|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233190|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233191|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233192|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233193|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233194|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233195|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233196|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233197|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233198|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233199|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233200|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233201|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233202|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233203|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233204|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233205|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233206|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233207|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233208|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233209|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233210|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233211|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233212|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233213|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233214|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233215|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233216|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233217|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233218|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233219|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233220|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233221|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233222|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233223|NCT01265784|E3|Reported Event|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233224|NCT01265784|E2|Reported Event|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233225|NCT01265784|E1|Reported Event|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
233226|NCT01265615|B5|Baseline|Total|Total of all reporting groups
233227|NCT01265615|B4|Baseline|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233228|NCT01265615|B3|Baseline|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233229|NCT01265615|B2|Baseline|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233230|NCT01265615|B1|Baseline|Paricalcitol Treatment|6-8 μg daily per os without special diet
233231|NCT01265615|P4|Participant Flow|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233232|NCT01265615|P3|Participant Flow|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233233|NCT01265615|P2|Participant Flow|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233234|NCT01265615|P1|Participant Flow|Paricalcitol Treatment|6-8 μg daily per os without special diet
233235|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233236|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233237|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233238|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
233239|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233240|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233241|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233242|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
233243|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233244|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233245|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233246|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
233247|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233248|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233249|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233250|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
233251|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233252|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233253|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233254|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
233255|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233256|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233257|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233258|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
233259|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233260|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233261|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233262|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
233263|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233400|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233264|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233265|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233266|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
233267|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233268|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233269|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233270|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
233271|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233272|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233273|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233274|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
233275|NCT01265615|E4|Reported Event|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
233276|NCT01265615|E3|Reported Event|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
233277|NCT01265615|E2|Reported Event|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
233278|NCT01265615|E1|Reported Event|Paricalcitol Treatment|6-8 μg daily per os without special diet
233279|NCT01265563|B6|Baseline|Total|Total of all reporting groups
233280|NCT01265563|B5|Baseline|NAC Active and High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
233281|NCT01265563|B4|Baseline|NAC Active and Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
233282|NCT01265563|B3|Baseline|NAC Placebo and Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
233283|NCT01265563|B2|Baseline|NAC Active and Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
233284|NCT01265563|B1|Baseline|NAC Placebo and Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
233285|NCT01265563|P5|Participant Flow|NAC Active + High Dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
233286|NCT01265563|P4|Participant Flow|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
233287|NCT01265563|P3|Participant Flow|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
263318|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
233288|NCT01265563|P2|Participant Flow|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
233289|NCT01265563|P1|Participant Flow|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
233290|NCT01265563|O5|Outcome|NAC Active + High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
233291|NCT01265563|O4|Outcome|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
233292|NCT01265563|O3|Outcome|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
233293|NCT01265563|O2|Outcome|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
233294|NCT01265563|O1|Outcome|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
233295|NCT01265563|O5|Outcome|NAC Active + High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
233296|NCT01265563|O4|Outcome|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
233297|NCT01265563|O3|Outcome|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
233298|NCT01265563|O2|Outcome|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
233299|NCT01265563|O1|Outcome|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
233334|NCT01265511|O1|Outcome|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233401|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233300|NCT01265563|E5|Reported Event|NAC Active + High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
233301|NCT01265563|E4|Reported Event|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
233302|NCT01265563|E3|Reported Event|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
233303|NCT01265563|E2|Reported Event|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
233304|NCT01265563|E1|Reported Event|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
233305|NCT01265524|B3|Baseline|Total|Total of all reporting groups
233306|NCT01265524|B2|Baseline|Placebo|Placebo: capsules
233307|NCT01265524|B1|Baseline|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
233308|NCT01265524|P2|Participant Flow|Placebo|Placebo: capsules
233309|NCT01265524|P1|Participant Flow|Investigational Drug: CLP|Investigational drug: 15 g CLP per day given as capsules
233310|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
233311|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
233312|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
233313|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
233314|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
233315|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
233316|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
233317|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
233318|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
233319|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
233320|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
233321|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
233322|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
233323|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
233324|NCT01265524|E2|Reported Event|Placebo|Placebo: capsules
233325|NCT01265524|E1|Reported Event|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
233326|NCT01265511|B3|Baseline|Total|Total of all reporting groups
233327|NCT01265511|B2|Baseline|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233328|NCT01265511|B1|Baseline|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233329|NCT01265511|P2|Participant Flow|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233330|NCT01265511|P1|Participant Flow|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233331|NCT01265511|O2|Outcome|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233332|NCT01265511|O1|Outcome|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233333|NCT01265511|O2|Outcome|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233335|NCT01265511|O2|Outcome|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233336|NCT01265511|O1|Outcome|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233337|NCT01265511|O2|Outcome|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233338|NCT01265511|O1|Outcome|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233339|NCT01265511|E2|Reported Event|SCY-635 600 mg|"SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
SCY-635: SCY-635 tablets, 300 mg bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233340|NCT01265511|E1|Reported Event|Placebo|"Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Placebo: Oral tablets given bid for 28 days
peginterferon alfa 2a: 180 ug prefilled syringe given once per week for up to 48 weeks
Ribavirin: tablets given bid for up to 48 weeks"
233341|NCT01265498|B3|Baseline|Total|Total of all reporting groups
233342|NCT01265498|B2|Baseline|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233343|NCT01265498|B1|Baseline|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233344|NCT01265498|P2|Participant Flow|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233345|NCT01265498|P1|Participant Flow|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233346|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233347|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233348|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233349|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233350|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233351|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233352|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233353|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233354|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233355|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233356|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233357|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233358|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233359|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233360|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233361|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233362|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233363|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233364|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233365|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233366|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233367|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233368|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233369|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233370|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233371|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233372|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233373|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233374|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233375|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233376|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233377|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233378|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233379|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233380|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233381|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233382|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233383|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233384|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233385|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233386|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233387|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233388|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233402|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233403|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233404|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233405|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233406|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233407|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233408|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233409|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233410|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233411|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233412|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233413|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233414|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233415|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233416|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233417|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233418|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233419|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233420|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233421|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233422|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233423|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233424|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233425|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233426|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233427|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233428|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233429|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233430|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233431|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233432|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233433|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233434|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233435|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233436|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233437|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233438|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233439|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233440|NCT01265498|O2|Outcome|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233441|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233442|NCT01265498|E2|Reported Event|Placebo|"Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks"
233443|NCT01265498|E1|Reported Event|Obeticholic Acid|"obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks"
233444|NCT01265459|B4|Baseline|Total|Total of all reporting groups
233445|NCT01265459|B3|Baseline|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233446|NCT01265459|B2|Baseline|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233447|NCT01265459|B1|Baseline|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233448|NCT01265459|P3|Participant Flow|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233449|NCT01265459|P2|Participant Flow|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233450|NCT01265459|P1|Participant Flow|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233451|NCT01265459|O3|Outcome|Durolane 6 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).
Single injection of Durolane (20 mg/ml)."
233452|NCT01265459|O2|Outcome|Durolane 4.5 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).
Single injection of Durolane (20 mg/ml)."
233453|NCT01265459|O1|Outcome|Durolane 3 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).
Single injection of Durolane (20 mg/ml)."
233454|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
233455|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
233456|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
233457|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
233458|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
268097|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
233459|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
233460|NCT01265459|O3|Outcome|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233461|NCT01265459|O2|Outcome|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233462|NCT01265459|O1|Outcome|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233463|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
233464|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
233465|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
233466|NCT01265459|E3|Reported Event|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233467|NCT01265459|E2|Reported Event|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233468|NCT01265459|E1|Reported Event|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
233469|NCT01265446|B3|Baseline|Total|Total of all reporting groups
233470|NCT01265446|B2|Baseline|Lidocaine 1mg + CPC 2mg|one single dose
233471|NCT01265446|B1|Baseline|Lidocaine 8mg +CPC 2mg|one single dose
233472|NCT01265446|P2|Participant Flow|Lidocaine 1mg + CPC 2mg|one single dose
233473|NCT01265446|P1|Participant Flow|Lidocaine 8mg +CPC 2mg|one single dose
233474|NCT01265446|O2|Outcome|Lidocaine 1mg + CPC 2mg|one single dose
233475|NCT01265446|O1|Outcome|Lidocaine 8mg +CPC 2mg|one single dose
233476|NCT01265446|O2|Outcome|Lidocaine 1mg + CPC 2mg|one single dose
233477|NCT01265446|O1|Outcome|Lidocaine 8mg +CPC 2mg|one single dose
233478|NCT01265446|E2|Reported Event|Lidocaine 1mg + CPC 2mg|one single dose
233479|NCT01265446|E1|Reported Event|Lidocaine 8mg +CPC 2mg|one single dose
233480|NCT01265420|B1|Baseline|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
233481|NCT01265420|P1|Participant Flow|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
233482|NCT01265420|O1|Outcome|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
233483|NCT01265420|E1|Reported Event|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
233484|NCT01265394|B1|Baseline|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
233485|NCT01265394|P1|Participant Flow|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
233486|NCT01265394|O1|Outcome|(18F) Flutemetamol Injection|Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
233487|NCT01265394|O1|Outcome|Normal and Abnormal Reads With or Without Amyloid|Each Subject received a dose of [18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
233488|NCT01265394|E1|Reported Event|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
233489|NCT01265056|B3|Baseline|Total|Total of all reporting groups
233490|NCT01265056|B2|Baseline|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
233491|NCT01265056|B1|Baseline|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
233492|NCT01265056|P2|Participant Flow|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
233493|NCT01265056|P1|Participant Flow|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
233494|NCT01265056|O2|Outcome|Gabapentin|Patients received gabapentin.
233495|NCT01265056|O1|Outcome|Placebo|Patients received a sugar pill similar to gabapentin.
233496|NCT01265056|E2|Reported Event|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
233497|NCT01265056|E1|Reported Event|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
233498|NCT01264952|B4|Baseline|Total|Total of all reporting groups
233499|NCT01264952|B3|Baseline|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
233500|NCT01264952|B2|Baseline|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
233501|NCT01264952|B1|Baseline|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
233502|NCT01264952|P3|Participant Flow|Group III|The third group included patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
233522|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233619|NCT01264770|P3|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO|Dosing Group C
233503|NCT01264952|P2|Participant Flow|Group II|The second group (group II) included patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
233504|NCT01264952|P1|Participant Flow|Group I|The first group included patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
233505|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
233506|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
233507|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
233508|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
233509|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
233510|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
233511|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
233512|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
233513|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
233514|NCT01264952|E3|Reported Event|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
233515|NCT01264952|E2|Reported Event|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
233516|NCT01264952|E1|Reported Event|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
233517|NCT01264939|B3|Baseline|Total|Total of all reporting groups
233518|NCT01264939|B2|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233519|NCT01264939|B1|Baseline|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233520|NCT01264939|P2|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233521|NCT01264939|P1|Participant Flow|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233523|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233524|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233525|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233526|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233527|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233528|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233529|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233530|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233531|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233532|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233533|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233534|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233535|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233536|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233537|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233538|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233539|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233540|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233541|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233542|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233543|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233544|NCT01264939|E2|Reported Event|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
233545|NCT01264939|E1|Reported Event|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
233546|NCT01263925|B3|Baseline|Total|Total of all reporting groups
233547|NCT01263925|B2|Baseline|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233548|NCT01263925|B1|Baseline|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233549|NCT01263925|P2|Participant Flow|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233550|NCT01263925|P1|Participant Flow|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233551|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233552|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233553|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233586|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
233554|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233555|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233556|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233557|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233558|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233559|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233560|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233561|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233562|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233563|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233564|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233565|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233566|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233567|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233585|NCT01263873|P1|Participant Flow|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
233932|NCT01263509|B3|Baseline|Total|Total of all reporting groups
233568|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233569|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233570|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233571|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233572|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233573|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233574|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233575|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233576|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233577|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233578|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233579|NCT01263925|E2|Reported Event|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
233580|NCT01263925|E1|Reported Event|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
233581|NCT01263873|B3|Baseline|Total|Total of all reporting groups
233582|NCT01263873|B2|Baseline|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
233583|NCT01263873|B1|Baseline|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
233584|NCT01263873|P2|Participant Flow|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
233617|NCT01264770|P5|Participant Flow|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO|Dosing Group F
233587|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
233588|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
233589|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
233590|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
233591|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
233592|NCT01263873|E2|Reported Event|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
233593|NCT01263873|E1|Reported Event|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
233594|NCT01264887|B1|Baseline|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
233595|NCT01264887|P1|Participant Flow|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
233596|NCT01264887|O1|Outcome|Frequency of Treatment Emergent Adverse Events|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
233597|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
233598|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
233599|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
233600|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
233601|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
233602|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
233603|NCT01264887|O1|Outcome|Number of Treatment Emergent Adverse Events|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
233604|NCT01264887|E1|Reported Event|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
233605|NCT01264835|B1|Baseline|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
233606|NCT01264835|P1|Participant Flow|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
233607|NCT01264835|O1|Outcome|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
233608|NCT01264835|E1|Reported Event|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
233609|NCT01264770|B7|Baseline|Total|Total of all reporting groups
233610|NCT01264770|B6|Baseline|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO|Dosing Group G
233611|NCT01264770|B5|Baseline|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO|Dosing Group F
233612|NCT01264770|B4|Baseline|ADALIMUMAB 40 MG SC|Dosing Group D
233613|NCT01264770|B3|Baseline|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO|Dosing Group C
233614|NCT01264770|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
233615|NCT01264770|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
233616|NCT01264770|P6|Participant Flow|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO|Dosing Group G
233620|NCT01264770|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
233621|NCT01264770|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
233622|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
233623|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
233624|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233625|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233626|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233627|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233628|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
233629|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
233630|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233631|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233632|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233633|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233634|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
233635|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
233636|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233637|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233638|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233639|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233640|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
233641|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233642|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233643|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233644|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233645|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233646|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233647|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233648|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233649|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
233650|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233651|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233652|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233653|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233654|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
233655|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
233656|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
233657|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233658|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233659|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233660|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233661|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
233662|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
233663|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
233664|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233665|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233666|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233667|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233668|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
233669|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
233670|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
233671|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233672|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233673|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233674|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233675|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
233676|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
233677|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233678|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233679|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233680|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233681|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
233682|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233683|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233684|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233685|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233686|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
233687|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
233688|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
233689|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233690|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233691|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233692|NCT01264770|O4|Outcome|Dosing Group E|PLACEBO (COMBINED)
233693|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
233694|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
233695|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
233696|NCT01264770|E8|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period|
233697|NCT01264770|E7|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period|
233698|NCT01264770|E6|Reported Event|PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-PBO Period|
233699|NCT01264770|E5|Reported Event|PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-FOSTAperiod|
233700|NCT01264770|E4|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|
233701|NCT01264770|E3|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD|Dosing Group C
233702|NCT01264770|E2|Reported Event|FOSTA 100 MG BID|Dosing Group A
233703|NCT01264770|E1|Reported Event|ADALIMUMAB 40 MG|Dosing Group D
233704|NCT01264614|B3|Baseline|Total|Total of all reporting groups
233705|NCT01264614|B2|Baseline|Normative Older Adults|Normative older adults with no known history of neurological condition.
233706|NCT01264614|B1|Baseline|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
233707|NCT01264614|P2|Participant Flow|Normative Older Adults|Normative older adults with no known history of neurological condition.
233708|NCT01264614|P1|Participant Flow|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
233709|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
233710|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
233711|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
233712|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
233713|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
233714|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
233715|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
233716|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
233717|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
233718|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
233719|NCT01264614|E2|Reported Event|Normative Older Adults|Normative older adults with no known history of neurological condition.
233720|NCT01264614|E1|Reported Event|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
233721|NCT01264380|B1|Baseline|All Participants|Included all participants who received single oral dose of vemurafenib tablet at 960 mg in fasted condition first and fed condition first in Period A and Period B and twice daily dose of vemurafenib tablet at 960 mg in Period C.
233722|NCT01264380|P3|Participant Flow|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
233723|NCT01264380|P2|Participant Flow|Vemurafenib (RO5185426): Fed Then Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition (Period A [Day 1 to Day 10]) followed by single oral dose of vemurafenib tablet at 960 mg on Day 1 in fasted condition Period B [Day 11 to Day 20]). A washout period of 10 days was maintained between Period A and B.
233724|NCT01264380|P1|Participant Flow|Vemurafenib (RO5185426): Fasted Then Fed|Single oral dose of vemurafenib tablet at 960 milligrams (mg) on Day 1 was administered to participants in fasted condition (Period A [Day 1 to Day 10]) followed by single oral dose of vemurafenib tablet at 960 mg on Day 1 in fed condition (Period B [Day 11 to Day 20]). A washout period of 10 days was maintained between Period A and B.
233725|NCT01264380|O1|Outcome|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
233726|NCT01264380|O1|Outcome|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
233727|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
233728|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
233729|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
233730|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
233731|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
233732|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
233733|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
233734|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
233735|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
236410|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
233736|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
233737|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
233738|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
233739|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
233740|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
233741|NCT01264380|E3|Reported Event|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
233742|NCT01264380|E2|Reported Event|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 milligram (mg) on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
233743|NCT01264380|E1|Reported Event|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 milligram (mg) on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
233744|NCT01264081|B1|Baseline|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
233745|NCT01264081|P1|Participant Flow|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
233746|NCT01264081|O1|Outcome|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
233747|NCT01264081|O1|Outcome|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
233748|NCT01264081|E1|Reported Event|Lapatinib|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
233749|NCT01264016|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system. One subject withdrew voluntarily; one subject was withdrawn. One subject hematocrit measurement was missing so subject data was not evaluable.
233750|NCT01264016|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
233751|NCT01264016|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
233752|NCT01264016|O1|Outcome|Study Staff Test Subject Venous Blood|Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood.
233753|NCT01264016|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
233754|NCT01264016|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
233755|NCT01263717|B3|Baseline|Total|Total of all reporting groups
233756|NCT01263717|B2|Baseline|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233757|NCT01263717|B1|Baseline|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233758|NCT01263717|P2|Participant Flow|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233759|NCT01263717|P1|Participant Flow|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233760|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233761|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233762|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233763|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233764|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233765|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233766|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233767|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233768|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233769|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233770|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233771|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233772|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233773|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233774|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233775|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233776|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233777|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233778|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233779|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233780|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233781|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233782|NCT01263717|E2|Reported Event|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
233783|NCT01263717|E1|Reported Event|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
233784|NCT01263691|B7|Baseline|Total|Total of all reporting groups
233785|NCT01263691|B6|Baseline|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233786|NCT01263691|B5|Baseline|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233787|NCT01263691|B4|Baseline|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233788|NCT01263691|B3|Baseline|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233789|NCT01263691|B2|Baseline|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233790|NCT01263691|B1|Baseline|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233791|NCT01263691|P6|Participant Flow|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233792|NCT01263691|P5|Participant Flow|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233793|NCT01263691|P4|Participant Flow|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233794|NCT01263691|P3|Participant Flow|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233795|NCT01263691|P2|Participant Flow|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233796|NCT01263691|P1|Participant Flow|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233797|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233798|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233799|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233800|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233801|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233802|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233803|NCT01263691|O18|Outcome|Female Saline|Female participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233804|NCT01263691|O17|Outcome|Female AV7909 Formulation 4|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233805|NCT01263691|O16|Outcome|Female AV7909 Formulation 3|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233806|NCT01263691|O15|Outcome|Female AV7909 Formulation 2|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233807|NCT01263691|O14|Outcome|Female AV7909 Formulation 1|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233808|NCT01263691|O13|Outcome|Female BioThrax|Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233809|NCT01263691|O12|Outcome|Male Saline|Male participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233810|NCT01263691|O11|Outcome|Male AV7909 Formulation 4|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233811|NCT01263691|O10|Outcome|Male AV7909 Formulation 3|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233812|NCT01263691|O9|Outcome|Male AV7909 Formulation 2|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233813|NCT01263691|O8|Outcome|Male AV7909 Formulation 1|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233814|NCT01263691|O7|Outcome|Male BioThrax|Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233815|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233816|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233817|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233818|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233819|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233820|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233821|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233822|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233823|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233824|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233825|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233826|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233827|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233828|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233829|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233830|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233831|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233832|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233833|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233834|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233835|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233836|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233837|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233838|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233839|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233840|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233841|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233842|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233843|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233844|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233845|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233846|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233847|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
234118|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
233848|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233849|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233850|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233851|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233852|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233853|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233854|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233855|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233856|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233857|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233858|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233859|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233860|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233861|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233862|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233863|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233864|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233865|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233866|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233867|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233868|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233869|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233870|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233871|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233872|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233873|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233874|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233875|NCT01263691|O18|Outcome|Female Saline|Female Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233876|NCT01263691|O17|Outcome|Female AV7909 Formulation 4|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233877|NCT01263691|O16|Outcome|Female AV7909 Formulation 3|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233878|NCT01263691|O15|Outcome|Female AV7909 Formulation 2|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
271456|NCT00057941|O1|Outcome|Anastrozole and ZD1839|
233879|NCT01263691|O14|Outcome|Female AV7909 Formulation 1|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233880|NCT01263691|O13|Outcome|Female BioThrax|Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233881|NCT01263691|O12|Outcome|Male Saline|Male Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233882|NCT01263691|O11|Outcome|Male AV7909 Formulation 4|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233883|NCT01263691|O10|Outcome|Male AV7909 Formulation 3|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233884|NCT01263691|O9|Outcome|Male AV7909 Formulation 2|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233885|NCT01263691|O8|Outcome|Male AV7909 Formulation 1|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233886|NCT01263691|O7|Outcome|Male BioThrax|Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233887|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233888|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233889|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233890|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233891|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233892|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
233893|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233894|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233895|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233896|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233897|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233898|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
236663|NCT01256684|P1|Participant Flow|Placebo|Placebo: Placebo vaginal suppository
233899|NCT01263691|E6|Reported Event|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
233900|NCT01263691|E5|Reported Event|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233901|NCT01263691|E4|Reported Event|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233902|NCT01263691|E3|Reported Event|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233903|NCT01263691|E2|Reported Event|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
233904|NCT01263691|E1|Reported Event|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
233905|NCT01263665|B1|Baseline|Investigational Arm|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
233906|NCT01263665|P1|Participant Flow|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|"25 cm length GORE® VIABAHN® Endoprosthesis with
> PROPATEN Bioactive Surface Subjects"
233907|NCT01263665|O1|Outcome|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
233908|NCT01263665|O1|Outcome|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
233909|NCT01263665|E1|Reported Event|25 cm GORE VIABAHN|25 cm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
233910|NCT01263639|B3|Baseline|Total|Total of all reporting groups
233911|NCT01263639|B2|Baseline|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
233912|NCT01263639|B1|Baseline|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
233913|NCT01263639|P2|Participant Flow|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
233914|NCT01263639|P1|Participant Flow|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
233915|NCT01263639|O2|Outcome|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
233916|NCT01263639|O1|Outcome|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
233917|NCT01263639|E2|Reported Event|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
233918|NCT01263639|E1|Reported Event|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
233919|NCT01263561|B3|Baseline|Total|Total of all reporting groups
233920|NCT01263561|B2|Baseline|ExPRESS|"ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
233921|NCT01263561|B1|Baseline|Trabeculectomy|"trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery"
233922|NCT01263561|P2|Participant Flow|ExPRESS|"ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
233923|NCT01263561|P1|Participant Flow|Trabeculectomy|"trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery"
233924|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
233925|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery"
233926|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
233927|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery"
233928|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
233929|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery"
233930|NCT01263561|E2|Reported Event|ExPRESS|"ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
233931|NCT01263561|E1|Reported Event|Trabeculectomy|"trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery"
233933|NCT01263509|B2|Baseline|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233934|NCT01263509|B1|Baseline|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233935|NCT01263509|P4|Participant Flow|α-glucosidase Monotherapy Group*→ 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
233936|NCT01263509|P3|Participant Flow|α-glucosidase Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
233937|NCT01263509|P2|Participant Flow|25 mg Combination Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
*for participants from the for 25 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
233938|NCT01263509|P1|Participant Flow|12.5 mg Combination Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
233939|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233940|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233941|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233942|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233943|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233944|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233945|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233946|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233947|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233948|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233949|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233950|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233951|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233952|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233953|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233954|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233955|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233956|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233957|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233958|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233959|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233960|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233961|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233962|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233963|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233964|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234119|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
233965|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233966|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233967|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233968|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233969|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233970|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233971|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233972|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233973|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233974|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233975|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233976|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233977|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233978|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233979|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233980|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233981|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233982|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233983|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233984|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233985|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233986|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233987|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233988|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233989|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233990|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233991|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233992|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233993|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233994|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233995|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233996|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233997|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233998|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
233999|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234120|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234000|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234001|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234002|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234003|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234004|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234005|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234006|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234007|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234008|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234009|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234010|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234011|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234012|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234013|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234014|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234015|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234016|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234017|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234018|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234019|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234020|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234021|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234022|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234023|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234024|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234025|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234026|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234027|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234028|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234029|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234030|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234031|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234032|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234033|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234034|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234121|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234035|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234036|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234037|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234038|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234039|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234040|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234041|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234042|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234043|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234044|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234045|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234046|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234047|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234048|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234049|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234050|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234051|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234052|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234053|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234054|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234055|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234056|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234057|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234058|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234059|NCT01263509|E2|Reported Event|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234060|NCT01263509|E1|Reported Event|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234061|NCT01263496|B6|Baseline|Total|Total of all reporting groups
234062|NCT01263496|B5|Baseline|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234063|NCT01263496|B4|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234064|NCT01263496|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234065|NCT01263496|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234066|NCT01263496|B1|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234067|NCT01263496|P9|Participant Flow|Placebo Dose Group* → Alogliptin 50 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
234068|NCT01263496|P8|Participant Flow|Placebo Dose Group* → Alogliptin 25 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
234069|NCT01263496|P7|Participant Flow|Placebo Dose Group* → Alogliptin 12.5 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
234070|NCT01263496|P6|Participant Flow|Placebo Dose Group* → Alogliptin 6.25 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
234602|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
234071|NCT01263496|P5|Participant Flow|Voglibose 0.2 mg Dose Group* → Voglibose 0.2 mg Dose Group|"Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
*for participants from the voglibose 0.2 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
234072|NCT01263496|P4|Participant Flow|Alogliptin 50 mg Dose Group* → Alogliptin 50 mg Dose Group|"Alogliptin 50 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
*for participants from the 50 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
234073|NCT01263496|P3|Participant Flow|Alogliptin 25 mg Dose Group* → Alogliptin 25 mg Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
*for participants from the 25 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
234074|NCT01263496|P2|Participant Flow|Alogliptin 12.5 mg Dose Group* → Alogliptin 12.5 mg Dose Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
*for participants from the 12.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
234075|NCT01263496|P1|Participant Flow|Alogliptin 6.25 mg Dose Group* → Alogliptin 6.25 mg Dose Group|"Alogliptin 6.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
*for participants from the 6.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
234076|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234077|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234078|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234079|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234080|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234081|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234082|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234083|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234084|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234085|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234086|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234087|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234088|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234089|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234090|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234091|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234092|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234093|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234094|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234095|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234096|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234097|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234098|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234099|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234100|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234101|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234102|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234103|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234104|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234105|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234106|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234107|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234108|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234109|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234110|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234111|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234112|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234113|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234114|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234115|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234116|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234117|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
273507|NCT00069823|B1|Baseline|Placebo|40 mg of placebo twice daily
234122|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234123|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234124|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234125|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234126|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234127|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234128|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234129|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234130|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234131|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234132|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234133|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234134|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234135|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234136|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234137|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234138|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234139|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234140|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234141|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234142|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234143|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234144|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234145|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234146|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234147|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234148|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234149|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234150|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234151|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234152|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234153|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234154|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234155|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234156|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234157|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234158|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234159|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234160|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234161|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234162|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234163|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234164|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234165|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234166|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234167|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234168|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234169|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234170|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234171|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234172|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234173|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234174|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234175|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234176|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234177|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234178|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234179|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234180|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234181|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234182|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234183|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234184|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234185|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234186|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234187|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234188|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234189|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234190|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234191|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234192|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234193|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234194|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234195|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234196|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234197|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234198|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234199|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234200|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234201|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234202|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234203|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234204|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234205|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234206|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234207|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234208|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234209|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234210|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234211|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234212|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234213|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234214|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234215|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234216|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234217|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234218|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234219|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234220|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234221|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234222|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234223|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234224|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234225|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234226|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234227|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234228|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234229|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234230|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234231|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234232|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234233|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234234|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234235|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234236|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234237|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234238|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234239|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234240|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234241|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234242|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234243|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234244|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234245|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234246|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234247|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234248|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234249|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234250|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234251|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234252|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234253|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234254|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234255|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234256|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234257|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234258|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234259|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234260|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234261|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234262|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234263|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234264|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234265|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234266|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234267|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234268|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234269|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234270|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234271|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234272|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234273|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234274|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234275|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234276|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234277|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234278|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234279|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234280|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234281|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234282|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234283|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234284|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234285|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234286|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234287|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234288|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234289|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234290|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234291|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234292|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234293|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234294|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234295|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234296|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234297|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234298|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234299|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234300|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234301|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234302|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234303|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234304|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234305|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234306|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234307|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234308|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234309|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234310|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234311|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234312|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234313|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234314|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234315|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234316|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234317|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234318|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234319|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234320|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234321|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234322|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234323|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234324|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234325|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234326|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234327|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234328|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234329|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234330|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234331|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234332|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234333|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234334|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234335|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234336|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234337|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234338|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234339|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234340|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234341|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234342|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234343|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234344|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234345|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234346|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234347|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234348|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234349|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234350|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234351|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234352|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234353|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234354|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234355|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234356|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234357|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234358|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234359|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234360|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234361|NCT01263496|E5|Reported Event|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
234362|NCT01263496|E4|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
234363|NCT01263496|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
234364|NCT01263496|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
234365|NCT01263496|E1|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
234366|NCT01263483|B4|Baseline|Total|Total of all reporting groups
234367|NCT01263483|B3|Baseline|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234368|NCT01263483|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234369|NCT01263483|B1|Baseline|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234370|NCT01263483|P3|Participant Flow|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234371|NCT01263483|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234372|NCT01263483|P1|Participant Flow|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234373|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234374|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234375|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234376|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234377|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234378|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234379|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234380|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234381|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234382|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234383|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234384|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234385|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234386|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234387|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234388|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234389|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234390|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234391|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234392|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234393|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234394|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234395|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234396|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234397|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234398|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234399|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234400|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234401|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234402|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234403|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234404|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234405|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234406|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234407|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234408|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234409|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234410|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234411|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234412|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234413|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234414|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234415|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234416|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234417|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234418|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234419|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234420|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234421|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234422|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234423|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234424|NCT01263483|E3|Reported Event|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234425|NCT01263483|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
234426|NCT01263483|E1|Reported Event|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234427|NCT01263470|B7|Baseline|Total|Total of all reporting groups
234428|NCT01263470|B6|Baseline|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234429|NCT01263470|B5|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234430|NCT01263470|B4|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234431|NCT01263470|B3|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234432|NCT01263470|B2|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234433|NCT01263470|B1|Baseline|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234434|NCT01263470|P6|Participant Flow|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234435|NCT01263470|P5|Participant Flow|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234436|NCT01263470|P4|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234437|NCT01263470|P3|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234438|NCT01263470|P2|Participant Flow|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234439|NCT01263470|P1|Participant Flow|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234440|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234441|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234442|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234443|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234444|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234445|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234446|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234447|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234448|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234449|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234450|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234451|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234452|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234453|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234454|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234455|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234456|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234457|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234458|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234459|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234460|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234461|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234462|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234463|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234464|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234465|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234466|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234467|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234468|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234469|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234470|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234471|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234472|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234473|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234474|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234475|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234476|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234477|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234478|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234479|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234480|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234481|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234482|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234483|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234484|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234485|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234486|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234487|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234488|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234489|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234490|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234491|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234492|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234493|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234494|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234495|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234496|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234497|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234498|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234499|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234500|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234501|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234502|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234503|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234504|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234505|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234506|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234507|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234508|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234509|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234510|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234511|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234512|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234513|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234514|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234515|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234516|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234517|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234518|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234519|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234520|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234521|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234522|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234523|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234524|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234525|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234526|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234527|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234528|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234529|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234530|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234531|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234532|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234533|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234534|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234535|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234536|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234537|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234538|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
273645|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
234539|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234540|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234541|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234542|NCT01263470|E6|Reported Event|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
234543|NCT01263470|E5|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
234544|NCT01263470|E4|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
234545|NCT01263470|E3|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
234546|NCT01263470|E2|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
234547|NCT01263470|E1|Reported Event|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
234548|NCT01263444|B1|Baseline|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
234549|NCT01263444|P1|Participant Flow|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
234550|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
234551|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
234552|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
234553|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
234554|NCT01263444|E1|Reported Event|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
234555|NCT01263301|B3|Baseline|Total|Total of all reporting groups
234556|NCT01263301|B2|Baseline|Carotid Duplex for Hemodialytic Patients With SSS|After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
234557|NCT01263301|B1|Baseline|Carotid Duplex for Nonhemodialytic Patients Wtih SSS|using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
234558|NCT01263301|P2|Participant Flow|Carotid Duplex for Hemodialytic Patients|"After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of vertebral artery and subclavian artery in the ipsilateral side of vascular access.
However, before carotid duplex, we didn't know which patients will show SSS.All 11 hemodialytic patients completed the study but only 2 showed the results of SSS. And for further analysis, we used these only 2."
234559|NCT01263301|P1|Participant Flow|Carotid Duplex for Nonhemidialytic Patients Wtih SSS|using carotid duplex to study vertebral and subclavian artery, using cuff test to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test for patients in the two groups
234560|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have vertebral arterial flow remained unchanged during the test
234561|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have vertebral arterial flow remained unchanged during the test
234562|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have vertebral arterial flow reversed to normal pattern during the test
234563|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have vertebral arterial flow reversed to normal during the test
234564|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow remained unchanged during the cuff test
234565|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow remained unchanged during the cuff test
234566|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow reversed to normal pattern during the test
234567|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow reversed to normal during the test
234568|NCT01263301|E2|Reported Event|Carotid Duplex for Hemodialytic Patients With SSS|After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
234569|NCT01263301|E1|Reported Event|Carotid Duplex for Nonhemodialytic Patients Wtih SSS|using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
234570|NCT01263132|B3|Baseline|Total|Total of all reporting groups
234571|NCT01263132|B2|Baseline|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
234572|NCT01263132|B1|Baseline|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
234573|NCT01263132|P2|Participant Flow|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
234574|NCT01263132|P1|Participant Flow|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
234575|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
234576|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
234577|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
234578|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
234579|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
234580|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
234581|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
234582|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
234583|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
234584|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
234585|NCT01263132|E2|Reported Event|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
234586|NCT01263132|E1|Reported Event|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
234587|NCT01263054|B3|Baseline|Total|Total of all reporting groups
234588|NCT01263054|B2|Baseline|Medical Management|"Standard medical management
Medical Management: Standard medical management, physical therapy, and lifestyle changes."
234589|NCT01263054|B1|Baseline|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management
TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
234590|NCT01263054|P2|Participant Flow|Medical Management|"Standard medical management
Medical Management: Standard medical management, physical therapy, and lifestyle changes."
234591|NCT01263054|P1|Participant Flow|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management
TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
234592|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
234593|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
234594|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
234595|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
234596|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
234597|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
234598|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
234599|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
234600|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
234601|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
234603|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
234604|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
234605|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
234606|NCT01263054|E2|Reported Event|Medical Management|"Standard medical management
Medical Management: Standard medical management, physical therapy, and lifestyle changes."
234607|NCT01263054|E1|Reported Event|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management
TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
234608|NCT01263028|B1|Baseline|Ergocalciferol Supplementation|
234609|NCT01263028|P1|Participant Flow|Ergocalciferol Supplementation|
234610|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
234611|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
234612|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
234613|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
234614|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
234615|NCT01263028|E1|Reported Event|Ergocalciferol Supplementation|
234616|NCT01263015|B3|Baseline|Total|Total of all reporting groups
234617|NCT01263015|B2|Baseline|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234618|NCT01263015|B1|Baseline|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
234619|NCT01263015|P2|Participant Flow|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks.
234620|NCT01263015|P1|Participant Flow|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks.
234621|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234622|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
234623|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234624|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
234625|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234626|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
235009|NCT01262547|O3|Outcome|Control|Target sites did not receive any treatment
234627|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234628|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
234629|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234630|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
234631|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234632|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
234633|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234634|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
234635|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234636|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
234637|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234638|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
234639|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234640|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
234641|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234642|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
273646|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
235010|NCT01262547|O2|Outcome|Dermabrasion Alone|"Dermabrasion alone
Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
234643|NCT01263015|E2|Reported Event|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
234644|NCT01263015|E1|Reported Event|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
234645|NCT01262989|B1|Baseline|Participants Receiving Both Test Product and Reference Product|Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days) or reference product in Period 1 and test product in Period 2
234646|NCT01262989|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
234647|NCT01262989|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
234648|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
234649|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
234650|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
234651|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
234652|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
234653|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
234654|NCT01262989|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
234655|NCT01262989|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
234656|NCT01262872|B9|Baseline|Total|Total of all reporting groups
234657|NCT01262872|B8|Baseline|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234658|NCT01262872|B7|Baseline|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234659|NCT01262872|B6|Baseline|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
235036|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
234660|NCT01262872|B5|Baseline|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234661|NCT01262872|B4|Baseline|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234662|NCT01262872|B3|Baseline|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234663|NCT01262872|B2|Baseline|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234664|NCT01262872|B1|Baseline|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234665|NCT01262872|P8|Participant Flow|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234666|NCT01262872|P7|Participant Flow|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234667|NCT01262872|P6|Participant Flow|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234668|NCT01262872|P5|Participant Flow|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234669|NCT01262872|P4|Participant Flow|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234898|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234670|NCT01262872|P3|Participant Flow|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234671|NCT01262872|P2|Participant Flow|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234672|NCT01262872|P1|Participant Flow|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234673|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234674|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234675|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234676|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234677|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234678|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234679|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234680|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234681|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234682|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234683|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234684|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234685|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234686|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234687|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234688|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
236864|NCT01258153|B1|Baseline|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
234689|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234690|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234691|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234692|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234693|NCT01262872|O1|Outcome|Total “All 5” Group|A subset of samples selected for ply and phtD gene sequencing of S. pneumoniae isolates, isolated from nasopharyngeal samples across all time points and across study groups of Cohort 2 (Prev13_3 group was excluded).
234694|NCT01262872|O1|Outcome|Total “All 5” Group|A subset of samples selected for ply and phtD gene sequencing of S. pneumoniae isolates, isolated from nasopharyngeal samples across all time points and across study groups of Cohort 2 (Prev13_3 group was excluded).
234695|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234696|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234697|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234698|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234899|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
273647|NCT00063635|O3|Outcome|Placebo|Matching placebo
234699|NCT01262872|O2|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234700|NCT01262872|O1|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234701|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234702|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234703|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234704|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234705|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234706|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234707|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
236865|NCT01258153|P3|Participant Flow|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
234708|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234709|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234710|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234711|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234712|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234713|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234714|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234715|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234716|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234933|NCT01262820|B1|Baseline|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
234717|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234718|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234719|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234720|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234721|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234722|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234723|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234724|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234725|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
236866|NCT01258153|P2|Participant Flow|Nepadutant High Dose|Nepadutant oral solution 0.5mg/kg: Oral administration once daily for 7 days
234726|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234727|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234728|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234729|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234730|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234731|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234732|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234733|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234734|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234934|NCT01262820|P1|Participant Flow|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
234735|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234736|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234737|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234738|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234739|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234740|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234741|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234742|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234743|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
236867|NCT01258153|P1|Participant Flow|Nepadutant Low Dose|Nepadutant oral solution 0.1mg/kg: Oral administration once daily for 7 days
234744|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234745|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234746|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234747|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234748|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234749|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234750|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234751|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234752|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234935|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
234753|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234754|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234755|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234756|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234757|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234758|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234759|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234760|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234761|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
236868|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
234762|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234763|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234764|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234765|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234766|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234767|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234768|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234769|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234795|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234770|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234771|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234772|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234773|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234774|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234775|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234776|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234777|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234796|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234778|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234779|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234780|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234781|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234782|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234783|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234784|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234785|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234806|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
273648|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
234786|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234787|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234788|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234789|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234790|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234791|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234792|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234793|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234794|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234936|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
234797|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234798|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234799|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234800|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234801|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234802|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234803|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234804|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234805|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
273649|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
234807|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234808|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234809|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234810|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234811|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234812|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234813|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234814|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234815|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
236869|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution 0.5mg/kg: Oral administration once daily for 7 days
234816|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234817|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234818|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234819|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234820|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234821|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234822|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234823|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234824|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234937|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
234825|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234826|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234827|NCT01262872|O2|Outcome|Synflorix 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234828|NCT01262872|O1|Outcome|10PP-HD 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234829|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234830|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234831|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
234832|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234833|NCT01262872|O2|Outcome|Synflorix 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
236870|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution 0.1mg/kg: Oral administration once daily for 7 days
234834|NCT01262872|O1|Outcome|10PP-HD 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234835|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234836|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
234837|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234838|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234839|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234840|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234841|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234842|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234938|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
234843|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234844|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234845|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234846|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234847|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234848|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234849|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234850|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234851|NCT01262872|O2|Outcome|Synflorix 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
236871|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
234852|NCT01262872|O1|Outcome|10PP-HD 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234853|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234854|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234855|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234856|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234857|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234858|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234859|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234860|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234939|NCT01262820|E1|Reported Event|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
234861|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234862|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234863|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234864|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234865|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234866|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234867|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234868|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234869|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
235072|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
234870|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234871|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234872|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234873|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234874|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234875|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234876|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234877|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234878|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
235037|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
234879|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234880|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234881|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234882|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234883|NCT01262872|O2|Outcome|Prevnar13 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234884|NCT01262872|O1|Outcome|10PP-HD 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234885|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234886|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234887|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234888|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234889|NCT01262872|O2|Outcome|Prevnar13 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234890|NCT01262872|O1|Outcome|10PP-HD 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234891|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234892|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234893|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234894|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234895|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234896|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234897|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
235038|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
234900|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234901|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234902|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234903|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234904|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234905|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234906|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234907|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234908|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234909|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234910|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234911|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234912|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234913|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234914|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
273650|NCT00063635|E3|Reported Event|Placebo|Matching placebo
234915|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234916|NCT01262872|E8|Reported Event|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234917|NCT01262872|E7|Reported Event|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234918|NCT01262872|E6|Reported Event|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234919|NCT01262872|E5|Reported Event|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234920|NCT01262872|E4|Reported Event|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234921|NCT01262872|E3|Reported Event|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
234922|NCT01262872|E2|Reported Event|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
234923|NCT01262872|E1|Reported Event|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
234924|NCT01262846|B3|Baseline|Total|Total of all reporting groups
234925|NCT01262846|B2|Baseline|Fluzone® High Dose|"Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject’s deltoid muscles.
Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
234926|NCT01262846|B1|Baseline|Fluzone SD|"Fluzone® Standard dose
Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
234927|NCT01262846|P2|Participant Flow|Fluzone® High Dose|"Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject’s deltoid muscles.
Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
234928|NCT01262846|P1|Participant Flow|Fluzone SD|"Fluzone® Standard dose
Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
234929|NCT01262846|O2|Outcome|HD Recipients|Fluzone High Dose
234930|NCT01262846|O1|Outcome|SD Recipients|Fluzone Regular Dose
234931|NCT01262846|E2|Reported Event|HD Recipients|
234932|NCT01262846|E1|Reported Event|SD Recipients|
234940|NCT01262755|B1|Baseline|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.
Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
234941|NCT01262755|P1|Participant Flow|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.
Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
234942|NCT01262755|O1|Outcome|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.
Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
234943|NCT01262755|E1|Reported Event|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.
Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
234944|NCT01262599|B3|Baseline|Total|Total of all reporting groups
234945|NCT01262599|B2|Baseline|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
234946|NCT01262599|B1|Baseline|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
234947|NCT01262599|P2|Participant Flow|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
234948|NCT01262599|P1|Participant Flow|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
234949|NCT01262599|O2|Outcome|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
234950|NCT01262599|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
234951|NCT01262599|E2|Reported Event|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
234952|NCT01262599|E1|Reported Event|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
234953|NCT01262573|B3|Baseline|Total|Total of all reporting groups
234954|NCT01262573|B2|Baseline|Smooth|"Vaginal cuff closure with smooth suture
Closure of vaginal cuff: Closure of the vaginal cuff"
234955|NCT01262573|B1|Baseline|Barbed|"Vaginal cuff closure with barbed suture
Closure of vaginal cuff: Closure of the vaginal cuff"
234956|NCT01262573|P2|Participant Flow|Smooth|"Vaginal cuff closure with smooth suture
Closure of vaginal cuff: Closure of the vaginal cuff"
234957|NCT01262573|P1|Participant Flow|Barbed|"Vaginal cuff closure with barbed suture
Closure of vaginal cuff: Closure of the vaginal cuff"
234958|NCT01262573|O2|Outcome|Smooth|"Vaginal cuff closure with smooth suture
Closure of vaginal cuff: Closure of the vaginal cuff"
234959|NCT01262573|O1|Outcome|Barbed|"Vaginal cuff closure with barbed suture
Closure of vaginal cuff: Closure of the vaginal cuff"
234960|NCT01262573|O2|Outcome|Smooth|"Vaginal cuff closure with smooth suture
Closure of vaginal cuff: Closure of the vaginal cuff"
234961|NCT01262573|O1|Outcome|Barbed|"Vaginal cuff closure with barbed suture
Closure of vaginal cuff: Closure of the vaginal cuff"
234962|NCT01262573|E2|Reported Event|Smooth|"Vaginal cuff closure with smooth suture
Closure of vaginal cuff: Closure of the vaginal cuff"
234963|NCT01262573|E1|Reported Event|Barbed|"Vaginal cuff closure with barbed suture
Closure of vaginal cuff: Closure of the vaginal cuff"
235004|NCT01262547|B1|Baseline|All Study Participants|"Dermabrasion-Micrografting, Dermabrasion and Control
Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).
Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline.
Control: Untreated depigmented area"
235005|NCT01262547|P1|Participant Flow|Patients With Vitiligo|Three subjects with vitiligo were recruited for the study. All subjects had three test sites that were studied. One site received dermabrasion and micrografting, one site received dermabrasion alone and one site was not treated and served as the control.
235006|NCT01262547|O3|Outcome|Control|Control
235007|NCT01262547|O2|Outcome|Dermabrasion Alone|"Dermabrasion alone
Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
235008|NCT01262547|O1|Outcome|Dermabrasion-Micrografting|"Dermabrasion-Micrografting
Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
235011|NCT01262547|O1|Outcome|Dermabrasion-Micrografting|"Dermabrasion-Micrografting
Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
235012|NCT01262547|E3|Reported Event|Control|"Control
Depigmented areas that did not receive any treatment."
235013|NCT01262547|E2|Reported Event|Dermabrasion Alone|"Dermabrasion alone
Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
235014|NCT01262547|E1|Reported Event|Dermabrasion-Micrografting|"Dermabrasion-Micrografting
Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
235015|NCT01262456|B4|Baseline|Total|Total of all reporting groups
235016|NCT01262456|B3|Baseline|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235017|NCT01262456|B2|Baseline|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235018|NCT01262456|B1|Baseline|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
274949|NCT00076245|E4|Reported Event|4 Control|
235019|NCT01262456|P3|Participant Flow|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
235020|NCT01262456|P2|Participant Flow|50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
235021|NCT01262456|P1|Participant Flow|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
235022|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
235023|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
235024|NCT01262456|O1|Outcome|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
235025|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235026|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235027|NCT01262456|O1|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235028|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
235029|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
235030|NCT01262456|O1|Outcome|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
235031|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235032|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235033|NCT01262456|O1|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235034|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235035|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235039|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235040|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235041|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235042|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235043|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
238247|NCT01253980|O1|Outcome|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
235044|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235045|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235046|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235047|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235048|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235049|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235050|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235051|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235052|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235053|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235054|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235055|NCT01262456|E6|Reported Event|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
235056|NCT01262456|E5|Reported Event|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
235057|NCT01262456|E4|Reported Event|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
235058|NCT01262456|E3|Reported Event|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235059|NCT01262456|E2|Reported Event|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235060|NCT01262456|E1|Reported Event|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
235061|NCT01262352|B3|Baseline|Total|Total of all reporting groups
235062|NCT01262352|B2|Baseline|Placebo Then Ivacaftor|Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
235063|NCT01262352|B1|Baseline|Ivacaftor Then Placebo|Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
235064|NCT01262352|P2|Participant Flow|Placebo Then Ivacaftor|Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
235065|NCT01262352|P1|Participant Flow|Ivacaftor Then Placebo|Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
235066|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
235067|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
235068|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
235069|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
235070|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
235071|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
235073|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
235074|NCT01262352|E2|Reported Event|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
235075|NCT01262352|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
235076|NCT01262339|B1|Baseline|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
235077|NCT01262339|P1|Participant Flow|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
235461|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
235078|NCT01262339|O1|Outcome|Active Comparator: Comparator of Hand A Intervention vs Hand B|Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
235079|NCT01262339|E1|Reported Event|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
235080|NCT01262287|B3|Baseline|Total|Total of all reporting groups
235081|NCT01262287|B2|Baseline|Placebo|"placebo daily for 8-week treatment period
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
235082|NCT01262287|B1|Baseline|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period
Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
235083|NCT01262287|P2|Participant Flow|Placebo|"placebo daily for 8-week treatment period
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
235084|NCT01262287|P1|Participant Flow|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period
Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
235085|NCT01262287|O4|Outcome|AKR1C3*2 G-carriers + Placebo|AKR1C3*2 G-carriers in placebo arm
235086|NCT01262287|O3|Outcome|AKR1C3*2 G-carriers + Dutasteride|AKR1C3*2 G-carriers in dutasteride arm (1 mg/day x 8 wks)
235087|NCT01262287|O2|Outcome|AKR1C3*2 C/C Genotype + Placebo|"AKR1C3*2 C/C genotype subjects in placebo arm
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
235088|NCT01262287|O1|Outcome|AKR1C3*2 C/C Genotype + Dutasteride|AKR1C3*2 C/C genotype subjects in dutasteride arm (1 mg daily for 8 wks)
235089|NCT01262287|O2|Outcome|Placebo|"placebo daily for 8-week treatment period
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
235090|NCT01262287|O1|Outcome|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period
Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
235091|NCT01262287|E2|Reported Event|Placebo|"placebo daily for 8-week treatment period
placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
235092|NCT01262287|E1|Reported Event|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period
Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
235093|NCT01262131|B4|Baseline|Total|Total of all reporting groups
235094|NCT01262131|B3|Baseline|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
235095|NCT01262131|B2|Baseline|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
235096|NCT01262131|B1|Baseline|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
235097|NCT01262131|P3|Participant Flow|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
235098|NCT01262131|P2|Participant Flow|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
235099|NCT01262131|P1|Participant Flow|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
235100|NCT01262131|O3|Outcome|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
235101|NCT01262131|O2|Outcome|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
235102|NCT01262131|O1|Outcome|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
235103|NCT01262131|E3|Reported Event|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
235104|NCT01262131|E2|Reported Event|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
235105|NCT01262131|E1|Reported Event|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
235106|NCT01262118|B3|Baseline|Total|Total of all reporting groups
235107|NCT01262118|B2|Baseline|Healthy Volunteers Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235108|NCT01262118|B1|Baseline|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235109|NCT01262118|P2|Participant Flow|Healthy Volunteers Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235110|NCT01262118|P1|Participant Flow|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235111|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235410|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235112|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235113|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235114|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235115|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235116|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235462|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
235117|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235118|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235119|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235120|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235121|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235122|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235123|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235124|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235125|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235126|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235127|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235128|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235129|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235130|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235131|NCT01262118|E2|Reported Event|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
235132|NCT01262118|E1|Reported Event|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
235133|NCT01262105|B3|Baseline|Total|Total of all reporting groups
235134|NCT01262105|B2|Baseline|Device Deployed|
235135|NCT01262105|B1|Baseline|No Device|
235136|NCT01262105|P2|Participant Flow|Device Deployed|
235137|NCT01262105|P1|Participant Flow|No Device|
235138|NCT01262105|O2|Outcome|Device Deployed|The ABS device is employed during surgery.
235139|NCT01262105|O1|Outcome|No Device|No device is deployed during surgery
235140|NCT01262105|E2|Reported Event|Device Deployed|
235141|NCT01262105|E1|Reported Event|No Device|
235142|NCT01262092|B3|Baseline|Total|Total of all reporting groups
235143|NCT01262092|B2|Baseline|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
235144|NCT01262092|B1|Baseline|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
235145|NCT01262092|P2|Participant Flow|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
235146|NCT01262092|P1|Participant Flow|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
235147|NCT01262092|O2|Outcome|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
235148|NCT01262092|O1|Outcome|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
235149|NCT01262092|E2|Reported Event|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
236837|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
235150|NCT01262092|E1|Reported Event|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
235151|NCT01262027|B1|Baseline|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
235152|NCT01262027|P1|Participant Flow|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
235153|NCT01262027|O1|Outcome|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
235154|NCT01262027|O1|Outcome|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
235155|NCT01262027|E1|Reported Event|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
235156|NCT01261975|B1|Baseline|Cataract Surgery|Cataract surgery with phacoemulsification using the Stellaris Vision Enhancement System
276216|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
235157|NCT01261975|P1|Participant Flow|Cataract Surgery|Cataract surgery with phacoemulsification. Eligible patients were randomized to undergo cataract surgery using the 1.8 mm coaxial micro incision technique in either the right eye or the left eye. The fellow eye was assigned to undergo cataract surgery using the 2.75 mm standard incision. The Stellaris Vision Enhancement System was used for the surgery.
235158|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
235159|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
235160|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
235161|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
235162|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
235163|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
235164|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
235165|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
235166|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
235167|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
235168|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
235169|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
235170|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
235171|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
235172|NCT01261975|E3|Reported Event|Cataract Surgery All Participants|Events by participant one eye with 1.8 mm coaxial micro-incision cataract surgery (C-MICS) and the contralateral eye with the 2.75 mm coaxial standard cataract surgery.
235173|NCT01261975|E2|Reported Event|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
235174|NCT01261975|E1|Reported Event|Co-Axial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System.
235175|NCT01261624|B3|Baseline|Total|Total of all reporting groups
235176|NCT01261624|B2|Baseline|High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID|Patient received the dose of 0.75 mg/kg for 12 weeks in fed condition
235177|NCT01261624|B1|Baseline|Low Dose Treatment Cohort (LDTC): 0.50 mg/kg BID|Patient received the dose of 0.50 mg/kg for 12 weeks in fed condition
235178|NCT01261624|P2|Participant Flow|High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID|Patients received the dose of 0.75 mg/kg BID for 12 weeks in fed conditions
235179|NCT01261624|P1|Participant Flow|Low Dose Treatment Cohort (LDTC): 0.50 mg/kg Twice Daily (BID)|Patients (pts) received the dose of 0.50 mg/kg BID for 12 weeks in fed condition
235180|NCT01261624|O5|Outcome|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
235181|NCT01261624|O4|Outcome|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
235182|NCT01261624|O3|Outcome|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort).
235411|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
235183|NCT01261624|O2|Outcome|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
235184|NCT01261624|O1|Outcome|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
235185|NCT01261624|O5|Outcome|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
235186|NCT01261624|O4|Outcome|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
235463|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
235187|NCT01261624|O3|Outcome|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort).
235188|NCT01261624|O2|Outcome|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
235189|NCT01261624|O1|Outcome|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
235190|NCT01261624|E5|Reported Event|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
235191|NCT01261624|E4|Reported Event|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
235192|NCT01261624|E3|Reported Event|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort). Safety data selected for high and low dose in this cohort are not available, this kind of analysis has not been performed.
235193|NCT01261624|E2|Reported Event|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
235194|NCT01261624|E1|Reported Event|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
235195|NCT01261559|B3|Baseline|Total|Total of all reporting groups
235196|NCT01261559|B2|Baseline|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
235197|NCT01261559|B1|Baseline|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
235198|NCT01261559|P2|Participant Flow|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
235199|NCT01261559|P1|Participant Flow|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
235200|NCT01261559|O2|Outcome|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
235201|NCT01261559|O1|Outcome|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
235202|NCT01261559|O2|Outcome|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
235203|NCT01261559|O1|Outcome|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
235204|NCT01261559|E2|Reported Event|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
235205|NCT01261559|E1|Reported Event|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
235206|NCT01261507|B1|Baseline|Radiologists|Board Certified Radiologists working in the Washington, DC, Baltimore region
236838|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
235207|NCT01261507|P1|Participant Flow|Board Certified Radiologists|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
235208|NCT01261507|O2|Outcome|Radiologists Working With Software|radiologists interpret the images using the experimental software
235209|NCT01261507|O1|Outcome|Radiologists Working Without Software|Radiologists interpret the same images without the use of software
235210|NCT01261507|O2|Outcome|Radiologists Working With Software|radiologists interpret the images using the experimental software
235211|NCT01261507|O1|Outcome|Radiologists Working Without Software|Radiologists interpret the same images without the use of software
235212|NCT01261507|O2|Outcome|Radiologists Working With Software|Each radiologist serves as own control, working without and with software. This is the arm working with software
235213|NCT01261507|O1|Outcome|Board Certified Radiologists Working Without Software|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
235214|NCT01261507|E1|Reported Event|Board Certified Radiologists|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
235215|NCT01261390|B5|Baseline|Total|Total of all reporting groups
235464|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
235216|NCT01261390|B4|Baseline|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235217|NCT01261390|B3|Baseline|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235218|NCT01261390|B2|Baseline|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235219|NCT01261390|B1|Baseline|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235220|NCT01261390|P4|Participant Flow|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235221|NCT01261390|P3|Participant Flow|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235222|NCT01261390|P2|Participant Flow|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235223|NCT01261390|P1|Participant Flow|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235224|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235225|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235226|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235238|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
276217|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
235227|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235228|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235229|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235230|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235231|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235232|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235233|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235234|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235258|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235412|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
235413|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235235|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235236|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235237|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235451|NCT01260922|E2|Reported Event|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
235239|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235240|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235241|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235242|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235243|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235244|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235245|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235246|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235247|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235248|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235249|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235452|NCT01260922|E1|Reported Event|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
235250|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235251|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235252|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235253|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235254|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235255|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235256|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235257|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235259|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235260|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235453|NCT01260896|B3|Baseline|Total|Total of all reporting groups
235454|NCT01260896|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
238248|NCT01253980|E2|Reported Event|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
235261|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235262|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235263|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235264|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235265|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235266|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235267|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235268|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235326|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235269|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235270|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235271|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235294|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235272|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235273|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235274|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235275|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235276|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235277|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235278|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235279|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235280|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235281|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235282|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235306|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
236872|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
235283|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235284|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235285|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235286|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235287|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235288|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235289|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235290|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235291|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235292|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235293|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235455|NCT01260896|B1|Baseline|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
235295|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235296|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235297|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235298|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235299|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235300|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235301|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235302|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235303|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235304|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235305|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235456|NCT01260896|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
235307|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235308|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235309|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235310|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235311|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235312|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235313|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235314|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235315|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235316|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235317|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235457|NCT01260896|P1|Participant Flow|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
235318|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235319|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235320|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235321|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235322|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235323|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235324|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235325|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235327|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235328|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235458|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
235459|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
235460|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
235329|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235330|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235331|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235332|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235333|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235334|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235335|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235336|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235358|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235337|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235338|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235339|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235362|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235340|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235341|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235342|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235343|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235344|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235345|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235346|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235357|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235404|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235347|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235348|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235349|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235350|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235446|NCT01260922|P1|Participant Flow|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
235447|NCT01260922|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
236873|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
235351|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235352|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235353|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235354|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235355|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235356|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235405|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
235406|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
236839|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
235359|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235360|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235361|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235448|NCT01260922|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
235363|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235364|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235365|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235366|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235367|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235368|NCT01261390|O2|Outcome|Active Treatment Arms (Pooled)|Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.
235369|NCT01261390|O1|Outcome|Control Arms (Pooled)|Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.
235370|NCT01261390|O2|Outcome|Active Treatment Arms (Pooled)|Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.
235371|NCT01261390|O1|Outcome|Control Arms (Pooled)|Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.
235372|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235407|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235408|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
235409|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
235373|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235374|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235375|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235376|NCT01261390|O2|Outcome|Active PAP With Motivational Enhancement|Participants randomly assigned to Active PAP with Behavioral Modification arm (Active+Beh).
235377|NCT01261390|O1|Outcome|Active PAP With RT Support Only|Participants randomly assigned to either the Active PAP with RT Support arm (ActiveBeh).
235378|NCT01261390|O2|Outcome|Active Treatment Arms (Pooled)|Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.
235379|NCT01261390|O1|Outcome|Control Arms (Pooled)|Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.
235380|NCT01261390|E4|Reported Event|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
235381|NCT01261390|E3|Reported Event|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
235382|NCT01261390|E2|Reported Event|Sham PAP (Sham)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
235383|NCT01261390|E1|Reported Event|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
235384|NCT01261325|B4|Baseline|Total Title|
235385|NCT01261325|B3|Baseline|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
235386|NCT01261325|B2|Baseline|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235387|NCT01261325|B1|Baseline|Placebo|Matching placebo tablets administered twice daily
235388|NCT01261325|P3|Participant Flow|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
235389|NCT01261325|P2|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235390|NCT01261325|P1|Participant Flow|Placebo|Matching placebo tablets administered twice daily
235391|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
235392|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235393|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
235394|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
235395|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235396|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
235397|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
235398|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235399|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
235400|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
235401|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235402|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
235403|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
235414|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
235415|NCT01261325|O3|Outcome|Placebo|Matching placebo tablets administered twice daily
235416|NCT01261325|O2|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
235417|NCT01261325|O1|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235418|NCT01261325|E3|Reported Event|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
235419|NCT01261325|E2|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
235420|NCT01261325|E1|Reported Event|Placebo|Matching placebo tablets administered twice daily
235421|NCT01261052|B1|Baseline|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
235449|NCT01260922|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
235422|NCT01261052|P1|Participant Flow|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
235423|NCT01261052|O1|Outcome|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
235424|NCT01261052|O1|Outcome|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
235425|NCT01261052|E2|Reported Event|FMPD/APD Intervention|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.
The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
235426|NCT01261052|E1|Reported Event|APD Only Intervention|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.
The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
235427|NCT01261000|B1|Baseline|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
235428|NCT01261000|P1|Participant Flow|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
235429|NCT01261000|O1|Outcome|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
235430|NCT01261000|E1|Reported Event|Pegvisomant|Pegvisomant: Pegvisomant used as indicated
235431|NCT01260948|B3|Baseline|Total|Total of all reporting groups
235432|NCT01260948|B2|Baseline|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
235433|NCT01260948|B1|Baseline|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
235434|NCT01260948|P2|Participant Flow|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
235435|NCT01260948|P1|Participant Flow|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
235436|NCT01260948|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
235437|NCT01260948|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
235438|NCT01260948|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
235439|NCT01260948|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
236840|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
235440|NCT01260948|E2|Reported Event|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
235441|NCT01260948|E1|Reported Event|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
235442|NCT01260922|B3|Baseline|Total|Total of all reporting groups
235443|NCT01260922|B2|Baseline|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
235444|NCT01260922|B1|Baseline|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
235445|NCT01260922|P2|Participant Flow|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
235450|NCT01260922|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
235465|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
235466|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
235467|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
235468|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
235469|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
235470|NCT01260896|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
235471|NCT01260896|E1|Reported Event|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
235472|NCT01260883|B4|Baseline|Total|Total of all reporting groups
235473|NCT01260883|B3|Baseline|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
235474|NCT01260883|B2|Baseline|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
235475|NCT01260883|B1|Baseline|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
235476|NCT01260883|P3|Participant Flow|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
235477|NCT01260883|P2|Participant Flow|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
235478|NCT01260883|P1|Participant Flow|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
235479|NCT01260883|O2|Outcome|Placebo Infusion|infants receiving placebo infusion after surgery
235480|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving ketorolac after surgery
235481|NCT01260883|O2|Outcome|Placebo Infusion|infants receiving placebo infusion after surgery
235482|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving ketorolac infusion after surgery
235483|NCT01260883|O3|Outcome|Placebo|noncompartmental analysis of stereo-isomers of ketorolac
235484|NCT01260883|O2|Outcome|R+ Ketorolac Half-life|noncompartmental analysis of stereo-isomers of ketorolac
235485|NCT01260883|O1|Outcome|S- Ketorolac Half-life|noncompartmental ketorolac analysis
235486|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235487|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235488|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analysis by NONMEM
235489|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235490|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution Central|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235491|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution Central|stereo-specific ketorolac analysis by NONMEM
235492|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235493|NCT01260883|O2|Outcome|R+ Ketorolac Clearance|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235494|NCT01260883|O1|Outcome|S- Ketorolac Clearance|stereo-specific ketorolac analysis by NONMEM
235495|NCT01260883|O2|Outcome|Placebo|infants given placebo intravenously after surgery
235496|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants given ketorolac intravenously after surgery
235497|NCT01260883|O2|Outcome|Placebo|infants receiving placebo infusion intravenously after surgery
235498|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving active drug intravenously after surgery
235499|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235500|NCT01260883|O2|Outcome|R+ Ketorolac Half-life|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235501|NCT01260883|O1|Outcome|S- Ketorolac Half-life|stereo-specific ketorolac analysis by NONMEM
235502|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235503|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235504|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analysis by NONMEM
235505|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235506|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Central|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
235507|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Central|stereo-specific ketorolac analysis by NONMEM
235508|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM)
235509|NCT01260883|O2|Outcome|R+ Ketorolac Clearance|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM)
235510|NCT01260883|O1|Outcome|S- Ketorolac Clearance|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration, analyzed by NONMEM population pharmacokinetic methodology
235511|NCT01260883|E3|Reported Event|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
235512|NCT01260883|E2|Reported Event|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
235513|NCT01260883|E1|Reported Event|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
235514|NCT01260701|B1|Baseline|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235515|NCT01260701|P1|Participant Flow|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
238249|NCT01253980|E1|Reported Event|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
235516|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235517|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235518|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235519|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235520|NCT01260701|E1|Reported Event|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235521|NCT01260688|B3|Baseline|Total|Total of all reporting groups
235522|NCT01260688|B2|Baseline|Arm II|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235523|NCT01260688|B1|Baseline|Arm I|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235524|NCT01260688|P2|Participant Flow|Arm II|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235525|NCT01260688|P1|Participant Flow|Arm I|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235526|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235527|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
235528|NCT01260688|E2|Reported Event|Arm II - Cediranib Alone|
235529|NCT01260688|E1|Reported Event|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
235530|NCT01260662|B4|Baseline|Total|Total of all reporting groups
235531|NCT01260662|B3|Baseline|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235532|NCT01260662|B2|Baseline|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235533|NCT01260662|B1|Baseline|Propofol|"Deep sedation using propofol (10 mg /mL)
Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235534|NCT01260662|P3|Participant Flow|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235535|NCT01260662|P2|Participant Flow|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235536|NCT01260662|P1|Participant Flow|Propofol|"Deep sedation using propofol (10 mg /mL)
Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235537|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235538|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235539|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)
Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
236841|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
236842|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
235540|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235541|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235542|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)
Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235543|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235544|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235545|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)
Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235546|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235547|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235548|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)
Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235549|NCT01260662|E3|Reported Event|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235550|NCT01260662|E2|Reported Event|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)
Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235551|NCT01260662|E1|Reported Event|Propofol|"Deep sedation using propofol (10 mg /mL)
Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
235552|NCT01260649|B3|Baseline|Total|Total of all reporting groups
235553|NCT01260649|B2|Baseline|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
235554|NCT01260649|B1|Baseline|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
235555|NCT01260649|P2|Participant Flow|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
235556|NCT01260649|P1|Participant Flow|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
235557|NCT01260649|O2|Outcome|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
235558|NCT01260649|O1|Outcome|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
235559|NCT01260649|O2|Outcome|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
235560|NCT01260649|O1|Outcome|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
235588|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
236843|NCT01258387|O2|Outcome|GGF2 First Dose|
236844|NCT01258387|O1|Outcome|Placebo|
235561|NCT01260649|E2|Reported Event|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
235562|NCT01260649|E1|Reported Event|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
235563|NCT01260584|B5|Baseline|Total|Total of all reporting groups
235564|NCT01260584|B4|Baseline|Prasugrel Then Clopidogrel Non-Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
235565|NCT01260584|B3|Baseline|Prasugrel Then Clopidogrel Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
236874|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
235566|NCT01260584|B2|Baseline|Clopidogrel Then Prasugrel Non-Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
235567|NCT01260584|B1|Baseline|Clopidogrel Then Prasugrel Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
235568|NCT01260584|P4|Participant Flow|Prasugrel Then Clopidogrel Non-Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
235569|NCT01260584|P3|Participant Flow|Prasugrel Then Clopidogrel Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
235570|NCT01260584|P2|Participant Flow|Clopidogrel Then Prasugrel Non-Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
235571|NCT01260584|P1|Participant Flow|Clopidogrel Then Prasugrel Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.
Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
235572|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
235573|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
235574|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
235575|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
235576|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
235577|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
235578|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
235579|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
235580|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
235581|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
235582|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
235583|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
235584|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
235585|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
235586|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
235587|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
236845|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
235589|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
235590|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
235591|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
235592|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
235593|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
235594|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
235595|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
235596|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
235597|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
235598|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
235599|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
235600|NCT01260584|E4|Reported Event|Clopidogrel Non-Smokers|"participants who do not currently smoke while receiving clopidogrel as test medication during study. 1 participant who started this arm was not at risk."
235601|NCT01260584|E3|Reported Event|Clopidogrel Smokers|"participants who currently smoke while receiving clopidogrel as test medication during study. 2 participants who started this arm were not At risk."
235602|NCT01260584|E2|Reported Event|Prasugrel Non-Smokers|"participants who do not currently smoke while receiving prasugrel as test medication during study. 1 participant who started the arm was not at risk."
235603|NCT01260584|E1|Reported Event|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
235604|NCT01260493|B3|Baseline|Total|Total of all reporting groups
235605|NCT01260493|B2|Baseline|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers
integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
235606|NCT01260493|B1|Baseline|Conventional Care, Controlgroup|conventional care, control group
235607|NCT01260493|P2|Participant Flow|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers
integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
235608|NCT01260493|P1|Participant Flow|Conventional Care, Controlgroup|conventional care, control group
235609|NCT01260493|O2|Outcome|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers
integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
235610|NCT01260493|O1|Outcome|Conventional Care, Controlgroup|conventional care, control group
235611|NCT01260493|E2|Reported Event|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers
integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
235612|NCT01260493|E1|Reported Event|Conventional Care, Controlgroup|conventional care, control group
235613|NCT01260467|B1|Baseline|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
235614|NCT01260467|P1|Participant Flow|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
235615|NCT01260467|O1|Outcome|Single Arm|No adverse events reported.
235616|NCT01260467|O1|Outcome|Memantine Arm|memantine: 10 milligrams orally twice a day
235617|NCT01260467|O1|Outcome|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
235618|NCT01260467|E1|Reported Event|Single Agent Memantine Group|NO data to report
235619|NCT01260454|B1|Baseline|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.
Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
235620|NCT01260454|P1|Participant Flow|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.
Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
235621|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.
Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
235622|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.
Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
235623|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.
Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
235624|NCT01260454|E1|Reported Event|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.
Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
235625|NCT01260350|B21|Baseline|Total|Total of all reporting groups
235626|NCT01260350|B20|Baseline|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
235627|NCT01260350|B19|Baseline|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
235628|NCT01260350|B18|Baseline|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235629|NCT01260350|B17|Baseline|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235630|NCT01260350|B16|Baseline|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235715|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235631|NCT01260350|B15|Baseline|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235632|NCT01260350|B14|Baseline|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235633|NCT01260350|B13|Baseline|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235634|NCT01260350|B12|Baseline|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235635|NCT01260350|B11|Baseline|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235636|NCT01260350|B10|Baseline|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235637|NCT01260350|B9|Baseline|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235638|NCT01260350|B8|Baseline|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235639|NCT01260350|B7|Baseline|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235640|NCT01260350|B6|Baseline|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235641|NCT01260350|B5|Baseline|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235642|NCT01260350|B4|Baseline|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235643|NCT01260350|B3|Baseline|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235644|NCT01260350|B2|Baseline|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235645|NCT01260350|B1|Baseline|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235646|NCT01260350|P22|Participant Flow|Group 22: LDV/SOF FDC 6 wk: GT 1, TN|Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
235647|NCT01260350|P21|Participant Flow|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
235648|NCT01260350|P20|Participant Flow|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
235649|NCT01260350|P19|Participant Flow|Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235650|NCT01260350|P18|Participant Flow|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235651|NCT01260350|P17|Participant Flow|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
236846|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
235652|NCT01260350|P16|Participant Flow|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg fixed-dose combination (FDC) once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235653|NCT01260350|P15|Participant Flow|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235654|NCT01260350|P14|Participant Flow|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235655|NCT01260350|P13|Participant Flow|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235656|NCT01260350|P12|Participant Flow|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus ledipasvir (LDV) 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235657|NCT01260350|P11|Participant Flow|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235658|NCT01260350|P10|Participant Flow|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
238250|NCT01253902|B4|Baseline|Total|Total of all reporting groups
235659|NCT01260350|P9|Participant Flow|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235660|NCT01260350|P8|Participant Flow|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235661|NCT01260350|P7|Participant Flow|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235662|NCT01260350|P6|Participant Flow|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235663|NCT01260350|P5|Participant Flow|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235664|NCT01260350|P4|Participant Flow|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235665|NCT01260350|P3|Participant Flow|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235666|NCT01260350|P2|Participant Flow|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235667|NCT01260350|P1|Participant Flow|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|Sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235668|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
235669|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
235670|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235671|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235672|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235673|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235674|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235675|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235676|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235677|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235678|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
236847|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
236848|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
235679|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235680|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235681|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235682|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235683|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235684|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235685|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235686|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
236875|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
235687|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235688|NCT01260350|O13|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235689|NCT01260350|O12|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235690|NCT01260350|O11|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235691|NCT01260350|O10|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235692|NCT01260350|O9|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235693|NCT01260350|O8|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235694|NCT01260350|O7|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235695|NCT01260350|O6|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235696|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235697|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235698|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235699|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235700|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235701|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
235702|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235703|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235704|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235705|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235706|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235707|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235708|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235709|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235710|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235711|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235712|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235713|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235714|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
236876|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
235716|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235717|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235718|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235719|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235720|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
235721|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
235722|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235723|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235724|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235725|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235726|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235727|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235728|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235729|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235730|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235731|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235732|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235733|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235734|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235735|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
236849|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
235736|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235737|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235738|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235739|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235740|NCT01260350|O17|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
235741|NCT01260350|O16|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235742|NCT01260350|O15|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235743|NCT01260350|O14|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
236877|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
235744|NCT01260350|O13|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235745|NCT01260350|O12|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235746|NCT01260350|O11|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235747|NCT01260350|O10|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235748|NCT01260350|O9|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235749|NCT01260350|O8|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235750|NCT01260350|O7|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235751|NCT01260350|O6|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235752|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235753|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235754|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235755|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235756|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235757|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
235758|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235759|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235760|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235761|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235762|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235791|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235763|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235764|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235765|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235766|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235767|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235768|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235769|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235770|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235771|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
236146|NCT01259375|O1|Outcome|All Patients|"All participants who received Amrubicin.
Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
235772|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235773|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235774|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235775|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235776|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
235777|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
235778|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235779|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235780|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235781|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235782|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235783|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235784|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235785|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235786|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235787|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235788|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235789|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235790|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235792|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235793|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235794|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235795|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235796|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
235797|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
235798|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235799|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
236147|NCT01259375|O1|Outcome|All Patients|"All participants enrolled.
Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
235800|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235801|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235802|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235803|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235804|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235805|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235806|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235807|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235808|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235809|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235810|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235811|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235812|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235813|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235814|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235815|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235816|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
235817|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
235818|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235819|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235820|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235821|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235822|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235823|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235824|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235825|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235826|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235827|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
236878|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
235828|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235829|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235830|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235831|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235832|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235833|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235834|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235835|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235836|NCT01260350|E20|Reported Event|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
235837|NCT01260350|E19|Reported Event|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
235838|NCT01260350|E18|Reported Event|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235839|NCT01260350|E17|Reported Event|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235840|NCT01260350|E16|Reported Event|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
235841|NCT01260350|E15|Reported Event|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235842|NCT01260350|E14|Reported Event|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235843|NCT01260350|E13|Reported Event|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235844|NCT01260350|E12|Reported Event|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
235845|NCT01260350|E11|Reported Event|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235846|NCT01260350|E10|Reported Event|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
236633|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
235847|NCT01260350|E9|Reported Event|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
235848|NCT01260350|E8|Reported Event|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
235849|NCT01260350|E7|Reported Event|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
235850|NCT01260350|E6|Reported Event|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235851|NCT01260350|E5|Reported Event|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235852|NCT01260350|E4|Reported Event|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235853|NCT01260350|E3|Reported Event|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235854|NCT01260350|E2|Reported Event|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
235855|NCT01260350|E1|Reported Event|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
235856|NCT01260324|B3|Baseline|Total|Total of all reporting groups
235857|NCT01260324|B2|Baseline|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
235858|NCT01260324|B1|Baseline|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
235859|NCT01260324|P2|Participant Flow|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
235860|NCT01260324|P1|Participant Flow|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
235861|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
235862|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
235863|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
235864|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
235865|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
235866|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
235905|NCT01260194|P1|Participant Flow|Trastuzumab|Trastuzumab was administered at a loading dose of 8 milligram per kilogram (mg/kg) body weight on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
236850|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
236851|NCT01258387|O2|Outcome|GGF2 First Dose|
235867|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
235868|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
235869|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
235870|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
235871|NCT01260324|E2|Reported Event|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
235918|NCT01260142|B5|Baseline|Cohort 3 (Sequence E)|Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
235872|NCT01260324|E1|Reported Event|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
235873|NCT01260311|B1|Baseline|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
235874|NCT01260311|P1|Participant Flow|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 milligram (mg) or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
235875|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
235876|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
235877|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
235878|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
235879|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
235880|NCT01260311|E1|Reported Event|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
235881|NCT01260272|B3|Baseline|Total|Total of all reporting groups
235882|NCT01260272|B2|Baseline|Raisin Group|"This group will receive raisins to consume three times a day with meals
Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
235883|NCT01260272|B1|Baseline|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables
Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
235884|NCT01260272|P2|Participant Flow|Raisin Group|"This group will receive raisins to consume three times a day with meals
Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
235906|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
236852|NCT01258387|O1|Outcome|Placebo|
235885|NCT01260272|P1|Participant Flow|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables
Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
235886|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals
Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
235887|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables
Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
235888|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals
Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
235914|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
235919|NCT01260142|B4|Baseline|Cohort 2 (Sequence D)|Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
235889|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables
Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
235890|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals
Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
235891|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables
Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
235892|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals
Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
235893|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables
Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
235894|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals
Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
235933|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
235895|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables
Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
235896|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals
Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
235897|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables
Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
235898|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals
Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
235915|NCT01260194|E1|Reported Event|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
235916|NCT01260142|B7|Baseline|Total|Total of all reporting groups
235917|NCT01260142|B6|Baseline|Cohort 3 ( Sequence F)|Participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
236879|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
235899|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables
Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
235900|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals
Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
235901|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables
Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
235902|NCT01260272|E2|Reported Event|Raisin Group|"This group will receive raisins to consume three times a day with meals
Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
235903|NCT01260272|E1|Reported Event|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables
Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
235904|NCT01260194|B1|Baseline|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
235907|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
235908|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
235909|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
235910|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
235911|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
235912|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
235913|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
235945|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
235920|NCT01260142|B3|Baseline|Cohort 2 (Sequence C)|Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
235921|NCT01260142|B2|Baseline|Cohort 1 (Sequence B)|Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
235922|NCT01260142|B1|Baseline|Cohort 1 (Sequence A)|Participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
235923|NCT01260142|P6|Participant Flow|Cohort 3 (Sequence F)|Participants were administered an intravenous IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
235924|NCT01260142|P5|Participant Flow|Cohort 3 (Sequence E)|Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
235925|NCT01260142|P4|Participant Flow|Cohort 2 (Sequence D)|Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
235926|NCT01260142|P3|Participant Flow|Cohort 2 (Sequence C)|Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
235927|NCT01260142|P2|Participant Flow|Cohort 1 (Sequence B)|Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
235928|NCT01260142|P1|Participant Flow|Cohort 1 (Sequence A)|Participants were administered intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
235929|NCT01260142|O3|Outcome|Cohort 3 (Fospropofol 15.0 : Propofol 1.5)|"Cohort 3 (Sequence E): participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
Cohort (Sequence F): participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium."
235930|NCT01260142|O2|Outcome|Cohort 2 (Fospropofol 10.0 : Propofol 1.0)|"Cohort 2 (Sequence C): Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
Cohort 2 (Sequence D): Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium."
235931|NCT01260142|O1|Outcome|Cohort 1 (Fospropofol 6.5 : Propofol 0.65)|"Cohort 1 (Sequence A): participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
Cohort 1: Sequence B: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium."
235932|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
236634|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
235934|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
235935|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
235936|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
235937|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
235938|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
235939|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
235940|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
235941|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
235942|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
235943|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
235944|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
235946|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
235947|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
235948|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
235949|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
235950|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
235951|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
235952|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
235953|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
235954|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
235955|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
235956|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
235957|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
235958|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
235959|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
235960|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
235961|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
235962|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
235963|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
235964|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
235965|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
235966|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
235967|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
235968|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
235969|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
235970|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
235971|NCT01260142|E6|Reported Event|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
235972|NCT01260142|E5|Reported Event|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
235973|NCT01260142|E4|Reported Event|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
235974|NCT01260142|E3|Reported Event|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
235975|NCT01260142|E2|Reported Event|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
236100|NCT01259466|O2|Outcome|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
235976|NCT01260142|E1|Reported Event|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
235977|NCT01259726|B5|Baseline|Total|Total of all reporting groups
235978|NCT01259726|B4|Baseline|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
235979|NCT01259726|B3|Baseline|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
235980|NCT01259726|B2|Baseline|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
235981|NCT01259726|B1|Baseline|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
235982|NCT01259726|P4|Participant Flow|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
235983|NCT01259726|P3|Participant Flow|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
235984|NCT01259726|P2|Participant Flow|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
235985|NCT01259726|P1|Participant Flow|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
235986|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
235987|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
235988|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
235989|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
235990|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
235991|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
235992|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
235993|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
235994|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
235995|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
235996|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
235997|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
235998|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
237716|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
235999|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
236000|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
236001|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
236002|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
236003|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
236004|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
236005|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
236006|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
236007|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
236008|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
236009|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
236010|NCT01259726|E4|Reported Event|VP20621 High Dose|VP20621: VP20621 as oral liquid once daily for 14 days
236011|NCT01259726|E3|Reported Event|VP20621 High Dose and Placebo|VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
236012|NCT01259726|E2|Reported Event|VP20621 Low Dose and Placebo|VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
236013|NCT01259726|E1|Reported Event|Placebo|Placebo: 10 mL placebo once daily for 14 days
236014|NCT01259713|B3|Baseline|Total|Total of all reporting groups
236015|NCT01259713|B2|Baseline|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236016|NCT01259713|B1|Baseline|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236017|NCT01259713|P2|Participant Flow|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236018|NCT01259713|P1|Participant Flow|Liposomal Amphotericin B|Liposomal amphotericin B (AmBisome®) 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236019|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236020|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236021|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236022|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236023|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236024|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236025|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236026|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236027|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236028|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236029|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236030|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236031|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236032|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236033|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236034|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236035|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236036|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236037|NCT01259713|E2|Reported Event|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236038|NCT01259713|E1|Reported Event|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
236039|NCT01259492|B5|Baseline|Total|Total of all reporting groups
236040|NCT01259492|B4|Baseline|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236101|NCT01259466|O1|Outcome|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
236102|NCT01259466|E2|Reported Event|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
276218|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
236041|NCT01259492|B3|Baseline|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236042|NCT01259492|B2|Baseline|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236043|NCT01259492|B1|Baseline|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236044|NCT01259492|P4|Participant Flow|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236045|NCT01259492|P3|Participant Flow|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236046|NCT01259492|P2|Participant Flow|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236303|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
237717|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
236047|NCT01259492|P1|Participant Flow|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236048|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236049|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236050|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236103|NCT01259466|E1|Reported Event|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
236104|NCT01259440|B3|Baseline|Total|Total of all reporting groups
236051|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236052|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236053|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236054|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236055|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236056|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236304|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
237718|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
236057|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236058|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236059|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236060|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236105|NCT01259440|B2|Baseline|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
236106|NCT01259440|B1|Baseline|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
236107|NCT01259440|P2|Participant Flow|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
236061|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236062|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236063|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236064|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236065|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236130|NCT01259427|E2|Reported Event|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
236066|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236067|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236068|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236069|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236070|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236108|NCT01259440|P1|Participant Flow|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
236071|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236072|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
236073|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
236074|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
236075|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236076|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236077|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236158|NCT01259297|B3|Baseline|Aliskiren + Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
236078|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236079|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236080|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236081|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236082|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236083|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236109|NCT01259440|O2|Outcome|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
236084|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236085|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236086|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236087|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236159|NCT01259297|B2|Baseline|Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
237719|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
236088|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236089|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236090|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236091|NCT01259492|E2|Reported Event|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
236092|NCT01259492|E1|Reported Event|All Ritalin LA|"All Ritalin LA:
In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients continued on their optimal dose."
236093|NCT01259466|B3|Baseline|Total|Total of all reporting groups
236094|NCT01259466|B2|Baseline|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
236095|NCT01259466|B1|Baseline|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
236096|NCT01259466|P2|Participant Flow|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
236097|NCT01259466|P1|Participant Flow|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
236098|NCT01259466|O2|Outcome|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
236099|NCT01259466|O1|Outcome|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
236110|NCT01259440|O1|Outcome|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
236111|NCT01259440|E2|Reported Event|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
236112|NCT01259440|E1|Reported Event|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
236113|NCT01259427|B3|Baseline|Total|Total of all reporting groups
236114|NCT01259427|B2|Baseline|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
236115|NCT01259427|B1|Baseline|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
236116|NCT01259427|P2|Participant Flow|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
236160|NCT01259297|B1|Baseline|Aliskiren + Hydrochlorothiazide (HCTZ)|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
236629|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
236117|NCT01259427|P1|Participant Flow|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
236118|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
236119|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
236120|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
236121|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
236122|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
236123|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
236124|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
236125|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
236144|NCT01259375|P1|Participant Flow|All Patients|"All participants enrolled.
Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
236145|NCT01259375|O1|Outcome|All Groups|All patients who had a partial or greater response
236126|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
236127|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
236128|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
236129|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
237720|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237721|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
236131|NCT01259427|E1|Reported Event|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
236132|NCT01259401|B3|Baseline|Total|Total of all reporting groups
236133|NCT01259401|B2|Baseline|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care
Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
236134|NCT01259401|B1|Baseline|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.
Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
236135|NCT01259401|P2|Participant Flow|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care
Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
236136|NCT01259401|P1|Participant Flow|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.
Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
236137|NCT01259401|O2|Outcome|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care
Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
236138|NCT01259401|O1|Outcome|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.
Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
236139|NCT01259401|O2|Outcome|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care
Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
236140|NCT01259401|O1|Outcome|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.
Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
236141|NCT01259401|E2|Reported Event|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care
Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
236142|NCT01259401|E1|Reported Event|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.
Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
236143|NCT01259375|B1|Baseline|All Groups|All patients that received treatment.
238498|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
236148|NCT01259375|O1|Outcome|All Patients|"All participants enrolled.
Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
236149|NCT01259375|O1|Outcome|All Patients|"All participants who received Amrubicin.
Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
236150|NCT01259375|O1|Outcome|All Patients|"All participants enrolled.
Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
236151|NCT01259375|E1|Reported Event|All Patients|"All participants enrolled.
Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
236152|NCT01259297|B9|Baseline|Total|Total of all reporting groups
236153|NCT01259297|B8|Baseline|Placebo for Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
236154|NCT01259297|B7|Baseline|Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were run-in stratum randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
236155|NCT01259297|B6|Baseline|Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
236156|NCT01259297|B5|Baseline|HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
236157|NCT01259297|B4|Baseline|Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
236161|NCT01259297|P8|Participant Flow|Placebo for Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
236162|NCT01259297|P7|Participant Flow|Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
236163|NCT01259297|P6|Participant Flow|Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
236164|NCT01259297|P5|Participant Flow|HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
236165|NCT01259297|P4|Participant Flow|Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
236166|NCT01259297|P3|Participant Flow|Aliskiren + Amlodipine|"In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.
In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
236167|NCT01259297|P2|Participant Flow|Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
236168|NCT01259297|P1|Participant Flow|Aliskiren + Hydrochlorothiazide (HCTZ)|"In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.
In double blind period, all patients who successfully completed run-in with HCTZ plus aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
236169|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
236664|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
236170|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
236171|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
236172|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
236173|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
236174|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
236175|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
236176|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
236177|NCT01259297|O2|Outcome|Placebo|This reporting group includes all the patients who has received placebo of aliskiren plus placebo of an additional BP lowering drug (amlodipine or hydrochlorothiazide). This reporting group includes patients from arms such as Placebo for Aliskiren + Placebo for HCTZ and Placebo for aliskiren + Placebo for Amlodipine .
236178|NCT01259297|O1|Outcome|Aliskiren+Amlodipine/HCTZ Group|This reporting group includes all the patients who has received Aliskiren plus an additional BP lowering drug (Amlodipine or Hydrochlorothiazide). This reporting group includes patients from arms such as Aliskiren + Hydrochlorothiazide (HCTZ) and Aliskiren + Amlodipine.
236179|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
236180|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
237722|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
236181|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
236182|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
236183|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
236184|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
236185|NCT01259297|E10|Reported Event|Double Blind Period: Placebo for Aliskiren + Placebo for Amlod|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
236186|NCT01259297|E9|Reported Event|Double Blind Period: Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
236187|NCT01259297|E8|Reported Event|Double Blind Period: Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
236188|NCT01259297|E7|Reported Event|Double Blind Period: HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
236189|NCT01259297|E6|Reported Event|Double Blind Period: Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
236190|NCT01259297|E5|Reported Event|Double Blind Period: Aliskiren + Amlodipine|"In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
236191|NCT01259297|E4|Reported Event|Double Blind Period: Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
236192|NCT01259297|E3|Reported Event|Double Blind Period: Aliskiren + Hydrochlorothiazide (HCTZ)|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
236193|NCT01259297|E2|Reported Event|Run-in Period: Aliskiren + Amlodipine|"In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.
Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
236194|NCT01259297|E1|Reported Event|Run-in Period: Aliskiren + Hydrochlorothiazide (HCTZ)|"In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received Hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.
Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
236195|NCT01259284|B4|Baseline|Total|Total of all reporting groups
236196|NCT01259284|B3|Baseline|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
236197|NCT01259284|B2|Baseline|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
236198|NCT01259284|B1|Baseline|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
236199|NCT01259284|P3|Participant Flow|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
236200|NCT01259284|P2|Participant Flow|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
236201|NCT01259284|P1|Participant Flow|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
236202|NCT01259284|O3|Outcome|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
236203|NCT01259284|O2|Outcome|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
236204|NCT01259284|O1|Outcome|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
236205|NCT01259284|E3|Reported Event|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
236206|NCT01259284|E2|Reported Event|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
236207|NCT01259284|E1|Reported Event|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
236208|NCT01259245|B3|Baseline|Total|Total of all reporting groups
236263|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236264|NCT01256944|O1|Outcome|Control|The normal women
236209|NCT01259245|B2|Baseline|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
236210|NCT01259245|B1|Baseline|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
236211|NCT01259245|P2|Participant Flow|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
236212|NCT01259245|P1|Participant Flow|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
236213|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
236214|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
236253|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236254|NCT01256944|O1|Outcome|Control|The normal women
236215|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
236216|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
236217|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
236218|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
236265|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236266|NCT01256944|O1|Outcome|Control|The normal women
237723|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
236219|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
236220|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
236221|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
236222|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
236223|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
236224|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
236225|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
236408|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236665|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
236226|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
236227|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
236228|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
236229|NCT01259245|O2|Outcome|PRP+Tai Chi|
236230|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|
236267|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236268|NCT01256944|O1|Outcome|Control|The normal women
236635|NCT01258595|E2|Reported Event|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
236231|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
236232|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
236233|NCT01259245|E2|Reported Event|Pulmonary Rehabilitation Program PRP|Subjects who received formal pulmonary rehabilitation program
236234|NCT01259245|E1|Reported Event|PRP + Tai Chi|Tai Chi elements added to PRP program
236235|NCT01256983|B3|Baseline|Total|Total of all reporting groups
236236|NCT01256983|B2|Baseline|No Intervention|10000 Lux after day 63
236237|NCT01256983|B1|Baseline|Light Box|"10000 lux after day 21
Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
236238|NCT01256983|P2|Participant Flow|No Intervention|10000 Lux after day 63
236239|NCT01256983|P1|Participant Flow|Light Box|"10000 lux after day 21
Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
236240|NCT01256983|O2|Outcome|No Intervention|10000 Lux after day 63
236241|NCT01256983|O1|Outcome|Light Box|"10000 lux after day 21
Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
236242|NCT01256983|E2|Reported Event|Wait-list Intervention|Wait-list design Intervention. Bright Light Therapy with 10000 lux beginning at day 63 until day 84, when the 9 study weeks were over.
236243|NCT01256983|E1|Reported Event|Bright Light Therapy|Bright Light Therapy with 10000 lux beginning at day 21 until day 42
236244|NCT01256944|B3|Baseline|Total|Total of all reporting groups
236245|NCT01256944|B2|Baseline|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236246|NCT01256944|B1|Baseline|Control|The normal women
236247|NCT01256944|P2|Participant Flow|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing’s syndrome)"
236248|NCT01256944|P1|Participant Flow|Control|The normal women
236249|NCT01256944|O4|Outcome|Nonb-obese With Control|BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI < 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
236250|NCT01256944|O3|Outcome|Non-obese With PCOS|"BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI < 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236251|NCT01256944|O2|Outcome|Obese With Control|BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
236252|NCT01256944|O1|Outcome|Obese With PCOS|"BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236666|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
276219|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
236255|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236256|NCT01256944|O1|Outcome|Control|The normal women
236257|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236258|NCT01256944|O1|Outcome|Control|The normal women
236259|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236260|NCT01256944|O1|Outcome|Control|The normal women
236261|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236262|NCT01256944|O1|Outcome|Control|The normal women
236302|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
236269|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236270|NCT01256944|O1|Outcome|Control|The normal women
236271|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing’s syndrome)"
236272|NCT01256944|O1|Outcome|Control|The normal women
236273|NCT01256944|E2|Reported Event|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:
Oligo- or anovulation
Clinical and/or biochemical signs of hyperandrogenism
Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
236274|NCT01256944|E1|Reported Event|Control|The normal women
236275|NCT01256918|B1|Baseline|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
236276|NCT01256918|P1|Participant Flow|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
236277|NCT01256918|O2|Outcome|Phacodepth|depth of penetration of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
236278|NCT01256918|O1|Outcome|Lens Thickness|lens thickness as measured using an A scan biometer
236279|NCT01256918|O2|Outcome|Phacodepth|actual depth of penetration (in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
236280|NCT01256918|O1|Outcome|Nuclear Opalescence|nuclear grading as per LOCS III criteria for cataract.nuclear opalescence is graded on a scale from 0.1 to 6.9 by comparing with standard photographs of cataract, under lens opacities classification system III, on a Haag Streit slit lamp under standard conditions of illumination
236281|NCT01256918|O2|Outcome|Phacodepth|actual depth of penetration(in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
236282|NCT01256918|O1|Outcome|Nuclear Colour|nuclear grading as per LOCS III criteria for cataract shall be done on a decimal scale from 0.1 to 6.9 nuclear colour is graded on a scale from 0.1 to 6.9 by comparing with standard photographs of cataract, under lens opacities classification system III, on a Haag Streit slit lamp under standard conditions of illumination
236283|NCT01256918|O1|Outcome|Posterior Capsular Rupture|A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop during the phacoemulsification procedure.
236284|NCT01256918|O1|Outcome|Phacodepth|A note shall be made of the phacodepth at which a complete vertical chop is achieved during the attempted vertical chop .
236285|NCT01256918|E1|Reported Event|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
236286|NCT01259115|B1|Baseline|Overall Study|Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 1; Washout Period for 4 to 18 days; Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 2.
236287|NCT01259115|P2|Participant Flow|Sequence B: BTDS 10 With Placebo (Reference) First|"Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo tablets twice daily (Reference) first
Washout Period of 4 to 18 days;
Period 2: BTDS 10 with ketoconazole 200 mg tablets twice daily."
236288|NCT01259115|P1|Participant Flow|Sequence A: BTDS 10 With Ketoconazole (Test) First|"Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily (Test) first;
Washout Period of 4 to 18 days;
Period 2: BTDS 10 with ketoconazole placebo tablets twice daily."
236289|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo oral tablets twice daily.
236290|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily.
236291|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
236292|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
236293|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
236294|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
236295|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
236296|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
236297|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
236298|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
236299|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
236300|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
236301|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
237724|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
236305|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
236306|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
236307|NCT01259115|O1|Outcome|All Subjects|Subjects who received BTDS with Ketoconazole treatment
236308|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
236309|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
236310|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
236311|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
236312|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
236313|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
236314|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
236315|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
236316|NCT01259115|E2|Reported Event|BTDS With Placebo|Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole placebo oral tablets twice daily.
236317|NCT01259115|E1|Reported Event|BTDS With Ketoconazole|Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole 200 mg oral tablets twice daily.
236318|NCT01259102|B6|Baseline|Total|Total of all reporting groups
236319|NCT01259102|B5|Baseline|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236320|NCT01259102|B4|Baseline|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
236409|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236321|NCT01259102|B3|Baseline|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236322|NCT01259102|B2|Baseline|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236323|NCT01259102|B1|Baseline|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236324|NCT01259102|P5|Participant Flow|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236325|NCT01259102|P4|Participant Flow|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
236326|NCT01259102|P3|Participant Flow|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236327|NCT01259102|P2|Participant Flow|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236328|NCT01259102|P1|Participant Flow|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236329|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236630|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
237725|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
236330|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
236331|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236332|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236333|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236334|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236335|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
236336|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236337|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236338|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236339|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236340|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
236341|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236342|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236343|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236344|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236345|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
236346|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236347|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236348|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236349|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
237726|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
236350|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
236351|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236352|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236353|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236354|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236355|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
236356|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236357|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236358|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236359|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236360|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
276220|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
236361|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236362|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236363|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236364|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236365|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
236366|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236367|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236368|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236369|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236370|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
236371|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236372|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236373|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236374|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236375|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
236376|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236377|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236378|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236379|NCT01259102|E5|Reported Event|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
236380|NCT01259102|E4|Reported Event|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
276221|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
236381|NCT01259102|E3|Reported Event|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
236382|NCT01259102|E2|Reported Event|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
236383|NCT01259102|E1|Reported Event|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
236384|NCT01259024|B1|Baseline|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads
transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
236385|NCT01259024|P1|Participant Flow|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads
transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
236386|NCT01259024|O1|Outcome|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads
transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
236631|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
236387|NCT01259024|E1|Reported Event|Doxorubicin-eluting LC Bead|"transarterial chemoembolization using doxorubicin-eluting LC Beads
transarterial chemoembolization using a drug-eluting bead: Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization."
236388|NCT01258998|B1|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
236389|NCT01258998|P1|Participant Flow|Akt Inhibitor MK2206|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
236390|NCT01258998|O1|Outcome|Akt Inhibitor MK2206|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
236391|NCT01258998|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally once a week, repeats every 28 days for up to 12 courses.
236392|NCT01258985|B3|Baseline|Total|Total of all reporting groups
236393|NCT01258985|B2|Baseline|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236394|NCT01258985|B1|Baseline|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236395|NCT01258985|P2|Participant Flow|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236396|NCT01258985|P1|Participant Flow|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236397|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236398|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236399|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236400|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236401|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236402|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236403|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236404|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236405|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236406|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236407|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
276222|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
236411|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236412|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236413|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236414|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236415|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236416|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236417|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236418|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236419|NCT01258985|E2|Reported Event|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
236420|NCT01258985|E1|Reported Event|Tai Chi|"12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi"
236421|NCT01258803|B1|Baseline|All Randomized Participants|
236422|NCT01258803|P6|Participant Flow|Treatment Sequence 6|Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI
236423|NCT01258803|P5|Participant Flow|Treatment Sequence 5|Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer
236424|NCT01258803|P4|Participant Flow|Treatment Sequence 4|Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer
236425|NCT01258803|P3|Participant Flow|Treatment Sequence 3|Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer
236426|NCT01258803|P2|Participant Flow|Treatment Sequence 2|Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer
236427|NCT01258803|P1|Participant Flow|Treatment Sequence 1|Treatment Period 1: Placebo Metered Dose Inhaler (MDI) with spacer, Treatment Period 2: Mometasone Furoate/Formoterol Fumarate (MF/F) MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F Dry Powder Inhaler (DPI)
236428|NCT01258803|O4|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
236429|NCT01258803|O3|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
236430|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
236431|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
236432|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
236433|NCT01258803|O1|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
236434|NCT01258803|O2|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
236435|NCT01258803|O1|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
236436|NCT01258803|O2|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
236437|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
236438|NCT01258803|O4|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
236439|NCT01258803|O3|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
236440|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
236441|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
236442|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
236443|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
236444|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
236445|NCT01258803|O1|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
236446|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
236447|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
236448|NCT01258803|E4|Reported Event|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
236449|NCT01258803|E3|Reported Event|F DPI|Participants receiving a single dose of F DPI 20 mcg
236450|NCT01258803|E2|Reported Event|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
236451|NCT01258803|E1|Reported Event|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
236452|NCT01258790|B3|Baseline|Total|Total of all reporting groups
236453|NCT01258790|B2|Baseline|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
236667|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
276223|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
236454|NCT01258790|B1|Baseline|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
236455|NCT01258790|P2|Participant Flow|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
236456|NCT01258790|P1|Participant Flow|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
236457|NCT01258790|O2|Outcome|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
236458|NCT01258790|O1|Outcome|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
236459|NCT01258790|E2|Reported Event|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
236460|NCT01258790|E1|Reported Event|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
236461|NCT01258738|B3|Baseline|Total|Total of all reporting groups
236462|NCT01258738|B2|Baseline|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236463|NCT01258738|B1|Baseline|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236464|NCT01258738|P2|Participant Flow|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236465|NCT01258738|P1|Participant Flow|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236466|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236467|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236468|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236469|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236470|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236471|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236472|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236880|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
236473|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236474|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236475|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236476|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236477|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236478|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236479|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236632|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
236480|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236481|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236482|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236483|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236484|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236485|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236486|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236487|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236488|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236489|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236490|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236491|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236492|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236493|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236494|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236495|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236496|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236497|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236498|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236499|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236500|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236501|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236502|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236503|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236504|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236505|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236506|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236507|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236508|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236509|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236510|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236511|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236512|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236513|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236514|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236515|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236516|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236517|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236518|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236519|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236520|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236521|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236522|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236523|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236524|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236525|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236526|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236527|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236528|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236529|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236530|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236531|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236532|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236533|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236534|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236535|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236536|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236537|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236538|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236539|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236540|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236541|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236542|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236543|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236544|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236545|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236546|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236547|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236548|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236549|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236550|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236551|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236552|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236553|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236554|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236555|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236556|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236557|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236558|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236559|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236560|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236561|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236562|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236563|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236564|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236565|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236566|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236567|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236568|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236569|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236570|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236571|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236572|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236573|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236574|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236575|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236576|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236577|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236578|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236579|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236580|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236581|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236582|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236583|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236584|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236585|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236586|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236587|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236588|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236589|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236590|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236591|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236592|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236593|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236594|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236595|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236596|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236597|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
236598|NCT01258738|E2|Reported Event|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).
236599|NCT01258738|E1|Reported Event|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).
236600|NCT01258660|B3|Baseline|Total|Total of all reporting groups
236601|NCT01258660|B2|Baseline|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236602|NCT01258660|B1|Baseline|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236603|NCT01258660|P2|Participant Flow|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236604|NCT01258660|P1|Participant Flow|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236668|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
236669|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
276224|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
236605|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236606|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236607|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236608|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236609|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236610|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236611|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236612|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236613|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236614|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236615|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236616|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236617|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236670|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
236618|NCT01258660|E2|Reported Event|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236619|NCT01258660|E1|Reported Event|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
236620|NCT01258595|B3|Baseline|Total|Total of all reporting groups
236621|NCT01258595|B2|Baseline|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
236622|NCT01258595|B1|Baseline|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
236623|NCT01258595|P2|Participant Flow|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
236624|NCT01258595|P1|Participant Flow|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
236625|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
236626|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
236627|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
236628|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
236699|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236636|NCT01258595|E1|Reported Event|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
236637|NCT01258582|B3|Baseline|Total|Total of all reporting groups
236638|NCT01258582|B2|Baseline|Oral Fluid|Oral fluid rapid HIV testing
236639|NCT01258582|B1|Baseline|Fingerstick|Fingerstick rapid HIV testing
236640|NCT01258582|P2|Participant Flow|Oral Fluid|Oral fluid rapid HIV testing
236641|NCT01258582|P1|Participant Flow|Fingerstick|Fingerstick rapid HIV testing
236642|NCT01258582|O2|Outcome|Oral HIV Testing|oral fluid rapid HIV testing
236643|NCT01258582|O1|Outcome|Fingerstick HIV Testing|whole-blood fingerstick rapid HIV testing
236644|NCT01258582|E2|Reported Event|Oral Fluid|Oral fluid rapid HIV testing
236645|NCT01258582|E1|Reported Event|Fingerstick|Fingerstick rapid HIV testing
236646|NCT01258504|B1|Baseline|Bosentan|bosentan 125 mg p.o. day 1 single dose bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
236647|NCT01258504|P1|Participant Flow|Bosentan|bosentan 125 mg p.o. single dose day 1 bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
236648|NCT01258504|O3|Outcome|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
236649|NCT01258504|O2|Outcome|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
236650|NCT01258504|O1|Outcome|Bosentan After First Dose|bosentan125 mg p.o. day 1 single dose
236651|NCT01258504|O3|Outcome|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
236652|NCT01258504|O2|Outcome|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
236653|NCT01258504|O1|Outcome|Bosentan After First Dose|bosentan 125 mg p.o. day 1 single dose
236654|NCT01258504|E3|Reported Event|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
236655|NCT01258504|E2|Reported Event|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
236656|NCT01258504|E1|Reported Event|Bosentan After First Dose|bosentan 125 mg p.o. day 1 single dose
236657|NCT01256684|B4|Baseline|Total|Total of all reporting groups
236658|NCT01256684|B3|Baseline|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
236659|NCT01256684|B2|Baseline|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
236660|NCT01256684|B1|Baseline|Placebo|Placebo: Placebo vaginal suppository
236661|NCT01256684|P3|Participant Flow|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
236662|NCT01256684|P2|Participant Flow|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
276225|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
236671|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
236672|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
236673|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
236674|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
236675|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
236676|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
236677|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
236678|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
236679|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
236680|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
236681|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
236682|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
236683|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
236684|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
236685|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
236686|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
236687|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
236688|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
236689|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
236690|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
236691|NCT01256684|E3|Reported Event|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
236692|NCT01256684|E2|Reported Event|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
236693|NCT01256684|E1|Reported Event|Placebo|Placebo: Placebo vaginal suppository
236694|NCT01256658|B3|Baseline|Total|Total of all reporting groups
236695|NCT01256658|B2|Baseline|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236696|NCT01256658|B1|Baseline|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236697|NCT01256658|P2|Participant Flow|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236698|NCT01256658|P1|Participant Flow|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236700|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236701|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236702|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236703|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236704|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236705|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236706|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236707|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236708|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236709|NCT01256658|O2|Outcome|Control|Not applicable to this outcome measure
236710|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236711|NCT01256658|O2|Outcome|Control|Not applicable to this outcome measure
236712|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236713|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236714|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236715|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236716|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236717|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236718|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236719|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236720|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236721|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
239262|NCT01251315|E6|Reported Event|Proimmune 200-B|Proimmune 200 High dose group
236722|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236723|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236724|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236725|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236726|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236727|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236728|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236729|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236730|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236731|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236732|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236733|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236734|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236735|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236736|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236737|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236738|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236739|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236740|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236741|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
236742|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236743|NCT01256658|E4|Reported Event|Control - Period 2- Follow-up Only|Participants from the control group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.
236744|NCT01256658|E3|Reported Event|Intervention - Period 2 - Follow-up Only|Participants from the intervention group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.
236745|NCT01256658|E2|Reported Event|Control - Period 1|Participants received COA566 treatment for symptomatic malaria episodes only.
236834|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
236746|NCT01256658|E1|Reported Event|Intervention - Period 1|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
236747|NCT01256567|B1|Baseline|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
236748|NCT01256567|P1|Participant Flow|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
Ramucirumab: Ramucirumab (IMC-1121B) administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
236749|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
236750|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel : Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
Ramucirumab : Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
236751|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
236752|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
236753|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
236754|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
236755|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
236756|NCT01256567|E1|Reported Event|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
236757|NCT01256502|B1|Baseline|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
236758|NCT01256502|P1|Participant Flow|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
236759|NCT01256502|O1|Outcome|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
236760|NCT01256502|O5|Outcome|Very Easy to Use|
236761|NCT01256502|O4|Outcome|Easy to Use|
236762|NCT01256502|O3|Outcome|Neither Difficult Nor Easy to Use|
236763|NCT01256502|O2|Outcome|Difficult to Use|
236764|NCT01256502|O1|Outcome|Very Difficult to Use|
236765|NCT01256502|O1|Outcome|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
236766|NCT01256502|E1|Reported Event|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
236767|NCT01256476|B3|Baseline|Total|Total of all reporting groups
236768|NCT01256476|B2|Baseline|Pravastatin 40 mg Once a Day (QD)|
236769|NCT01256476|B1|Baseline|Pitavastatin 4 mg Once a Day (QD)|
236770|NCT01256476|P2|Participant Flow|Pravastatin 40 mg Once a Day (QD)|
236771|NCT01256476|P1|Participant Flow|Pitavastatin 4 mg Once a Day (QD)|
236772|NCT01256476|O2|Outcome|Pravastatin 40 mg Once Daily (QD)|
236773|NCT01256476|O1|Outcome|Pitavastatin 4 mg Once Daily (QD)|
236774|NCT01256476|E2|Reported Event|Pravastatin 40 mg Once a Day (QD)|
236775|NCT01256476|E1|Reported Event|Pitavastatin 4 mg Once a Day (QD)|
236776|NCT01256450|B3|Baseline|Total|Total of all reporting groups
236777|NCT01256450|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236778|NCT01256450|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236779|NCT01256450|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236780|NCT01256450|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236781|NCT01256450|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
236782|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236783|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236784|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236785|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236835|NCT01258387|O2|Outcome|GGF2 First Dose|
236786|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236787|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236788|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236789|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236790|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236791|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236792|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236793|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236794|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236795|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236796|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236797|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236798|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236799|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236800|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236801|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
236802|NCT01256450|E3|Reported Event|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
236803|NCT01256450|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
236804|NCT01256450|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
236805|NCT01258387|B9|Baseline|Total|Total of all reporting groups
236806|NCT01258387|B8|Baseline|GGF2 Seventh Escalataed Dose|Seventh dosing: patients in cohort randomized to GGF2
236807|NCT01258387|B7|Baseline|GGF2 Sixth Escalated Dose|Sixth dosing: patients in cohort randomized to GGF2.
236808|NCT01258387|B6|Baseline|GGF2 Fifth Escalated Dose|Fifth dosing: patients in cohort randomized to GGF2
236809|NCT01258387|B5|Baseline|GGF2 Fourth Escalated Dose|Fourth dosing: patients in cohort randomized to GGF2
236810|NCT01258387|B4|Baseline|GGF2 Third Escalated Dose|Third dosing: patients in cohort randomized to GGF2
236811|NCT01258387|B3|Baseline|GGF2 Second Escalated Dose|Second dosing: patients in cohort randomized to GGF2
236812|NCT01258387|B2|Baseline|GGF2 First Dose|First dosing: patients in cohort randomized to GGF2
236813|NCT01258387|B1|Baseline|Placebo|Patients in each of 7 cohorts randomized to Placebo
236814|NCT01258387|P7|Participant Flow|GGF2 Seventh Escalataed Dose|Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
236815|NCT01258387|P6|Participant Flow|GGF2 Sixth Escalated Dose|Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed .
236816|NCT01258387|P5|Participant Flow|GGF2 Fifth Escalated Dose|Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
236817|NCT01258387|P4|Participant Flow|GGF2 Fourth Escalated Dose|Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
236818|NCT01258387|P3|Participant Flow|GGF2 Third Escalated Dose|Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
236819|NCT01258387|P2|Participant Flow|GGF2 Second Escalated Dose|Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
236820|NCT01258387|P1|Participant Flow|GGF2 First Dose|First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
236821|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
236822|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
236823|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
236824|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
236825|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
236826|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
236827|NCT01258387|O2|Outcome|GGF2 First Dose|
236828|NCT01258387|O1|Outcome|Placebo|
236829|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
236830|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
236831|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
236832|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
236833|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
236853|NCT01258387|E8|Reported Event|GGF2 Seventh Escalataed Dose|Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
236854|NCT01258387|E7|Reported Event|GGF2 Sixth Escalated Dose|Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed .
236855|NCT01258387|E6|Reported Event|GGF2 Fifth Escalated Dose|Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
236856|NCT01258387|E5|Reported Event|GGF2 Fourth Escalated Dose|Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
236857|NCT01258387|E4|Reported Event|GGF2 Third Escalated Dose|Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
236858|NCT01258387|E3|Reported Event|GGF2 Second Escalated Dose|Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
236859|NCT01258387|E2|Reported Event|GGF2 First Dose|First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
236860|NCT01258387|E1|Reported Event|Placebo|
236861|NCT01258153|B4|Baseline|Total|Total of all reporting groups
236862|NCT01258153|B3|Baseline|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
236863|NCT01258153|B2|Baseline|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
236881|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
236882|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
236883|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
236884|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
236885|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
236886|NCT01258153|E3|Reported Event|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
236887|NCT01258153|E2|Reported Event|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
236888|NCT01258153|E1|Reported Event|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
236889|NCT01258101|B5|Baseline|Total|Total of all reporting groups
236890|NCT01258101|B4|Baseline|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236891|NCT01258101|B3|Baseline|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236892|NCT01258101|B2|Baseline|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236893|NCT01258101|B1|Baseline|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236894|NCT01258101|P4|Participant Flow|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236895|NCT01258101|P3|Participant Flow|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236896|NCT01258101|P2|Participant Flow|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236897|NCT01258101|P1|Participant Flow|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W.
236898|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236899|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236900|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236901|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236902|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236903|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236904|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236905|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236906|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236907|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236908|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236909|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236910|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236911|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236912|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236913|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236914|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236915|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236916|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236917|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236918|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236919|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236920|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236921|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236922|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236923|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236924|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236925|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236926|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236927|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236928|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236929|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236930|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236931|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236932|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236933|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236934|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236935|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236936|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236937|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
237727|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
236938|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236939|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236940|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236941|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236942|NCT01258101|E4|Reported Event|Ribavirin 400 mg/16W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236943|NCT01258101|E3|Reported Event|Ribavirin 800 mg/16W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
236944|NCT01258101|E2|Reported Event|Ribavirin 400 mg/24W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
236945|NCT01258101|E1|Reported Event|Ribavirin 800 mg/24W|Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W.
236946|NCT01258049|B3|Baseline|Total|Total of all reporting groups
237087|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
placebo: liquid made to look like the active homeopathic remedy"
236947|NCT01258049|B2|Baseline|Quinine|A loading dose of 20 mg/kg was given over four hours and thereafter 10 mg/kg was given every eight hours until the subject was able to swallow. Thereafter, patients were given quinine syrup or crushed tablets (10 mg/kg every eight hours) or another suitable treatment to ensure they received at least seven days of therapy, or be converted to another suitable treatment or a suitable course of combination therapy, in accordance with national drugs policy where applicable
236948|NCT01258049|B1|Baseline|ArTiMist|"Doses of 3 mg/kg were administered sublingually at: 0 h, 8 h, 24 h, 36 h, 48 h, and 60 h.
Following the initial six doses, subjects could, at the discretion of the Investigator receive a further four daily doses of 3 mg/kg ArTiMist™ to complete a seven day treatment course, or be converted to another suitable treatment or a suitable course of combination therapy in accordance with national drugs policy where applicable."
236949|NCT01258049|P2|Participant Flow|Quinine|A loading dose of 20 mg/kg was given over four hours and thereafter 10 mg/kg was given every eight hours until the subject was able to swallow. Thereafter, patients were given quinine syrup or crushed tablets (10 mg/kg every eight hours) or another suitable treatment to ensure they received at least seven days of therapy, or be converted to another suitable treatment or a suitable course of combination therapy, in accordance with national drugs policy where applicable.
236950|NCT01258049|P1|Participant Flow|ArTiMist|Doses of 3 mg/kg were administered sublingually at: 0 h, 8 h, 24 h, 36 h, 48 h, and 60 h. Following the initial six doses, subjects could, at the discretion of the Investigator receive a further four daily doses of 3 mg/kg ArTiMist™ to complete a seven day treatment course, or be converted to another suitable treatment or a suitable course of combination therapy in accordance with national drugs policy where applicable.
236951|NCT01258049|O2|Outcome|Quinine|
236952|NCT01258049|O1|Outcome|ArTiMist|
236953|NCT01258049|O2|Outcome|Quinine|
236954|NCT01258049|O1|Outcome|ArTiMist|
236955|NCT01258049|O2|Outcome|Quinine|
236956|NCT01258049|O1|Outcome|ArTiMist|
236957|NCT01258049|O2|Outcome|Quinine|
236958|NCT01258049|O1|Outcome|ArTiMist|
236959|NCT01258049|O2|Outcome|Quinine|
236960|NCT01258049|O1|Outcome|ArTiMist|
236961|NCT01258049|O2|Outcome|Quinine|
236962|NCT01258049|O1|Outcome|ArTiMist|
236963|NCT01258049|O2|Outcome|Quinine|
236964|NCT01258049|O1|Outcome|ArTiMist|
236965|NCT01258049|O2|Outcome|Quinine|
236966|NCT01258049|O1|Outcome|ArTiMist|
236967|NCT01258049|O2|Outcome|Quinine|
236968|NCT01258049|O1|Outcome|ArTiMist|
236969|NCT01258049|O2|Outcome|Quinine|
236970|NCT01258049|O1|Outcome|ArTiMist|
236971|NCT01258049|O2|Outcome|Quinine|
236972|NCT01258049|O1|Outcome|ArTiMist|
236973|NCT01258049|O2|Outcome|Quinine|
236974|NCT01258049|O1|Outcome|ArTiMist|
236975|NCT01258049|O2|Outcome|Quinine|
236976|NCT01258049|O1|Outcome|ArTiMist|
236977|NCT01258049|O2|Outcome|Quinine|
236978|NCT01258049|O1|Outcome|ArTiMist|
236979|NCT01258049|O2|Outcome|Quinine|
236980|NCT01258049|O1|Outcome|ArTiMist|
236981|NCT01258049|O2|Outcome|Quinine|
236982|NCT01258049|O1|Outcome|ArTiMist|
236983|NCT01258049|E2|Reported Event|Quinine|
236984|NCT01258049|E1|Reported Event|ArTiMist|
236985|NCT01257880|B3|Baseline|Total|Total of all reporting groups
236986|NCT01257880|B2|Baseline|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
236987|NCT01257880|B1|Baseline|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
236988|NCT01257880|P2|Participant Flow|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
236989|NCT01257880|P1|Participant Flow|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
236990|NCT01257880|O2|Outcome|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
236991|NCT01257880|O1|Outcome|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
236992|NCT01257880|O2|Outcome|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
236993|NCT01257880|O1|Outcome|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
236994|NCT01257880|E2|Reported Event|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
236995|NCT01257880|E1|Reported Event|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
236996|NCT01257802|B3|Baseline|Total|Total of all reporting groups
236997|NCT01257802|B2|Baseline|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
236998|NCT01257802|B1|Baseline|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
236999|NCT01257802|P2|Participant Flow|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
237049|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237000|NCT01257802|P1|Participant Flow|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
237001|NCT01257802|O2|Outcome|PLACEBO|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
237002|NCT01257802|O1|Outcome|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
237003|NCT01257802|O2|Outcome|PLACEBO|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
237004|NCT01257802|O1|Outcome|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
237005|NCT01257802|O2|Outcome|PLACEBO|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
237006|NCT01257802|O1|Outcome|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
237007|NCT01257802|O2|Outcome|PLACEBO|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
237008|NCT01257802|O1|Outcome|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
237009|NCT01257802|O2|Outcome|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
237010|NCT01257802|O1|Outcome|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
237011|NCT01257802|E2|Reported Event|Placebo|"depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses"
237012|NCT01257802|E1|Reported Event|LUPRON|depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
237013|NCT01257750|B1|Baseline|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.
Frequency and Duration: 4 times per day for 3 weeks"
237014|NCT01257750|P1|Participant Flow|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.
Frequency and Duration: 4 times per day for 3 weeks"
237728|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237015|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.
Frequency and Duration: 4 times per day for 3 weeks"
237016|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.
Frequency and Duration: 4 times per day for 3 weeks"
237017|NCT01257750|E1|Reported Event|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.
Frequency and Duration: 4 times per day for 3 weeks"
237018|NCT01257581|B4|Baseline|Total|Total of all reporting groups
237019|NCT01257581|B3|Baseline|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237020|NCT01257581|B2|Baseline|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237021|NCT01257581|B1|Baseline|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237022|NCT01257581|P3|Participant Flow|Tamoxifen 80mg|"Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.
Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.
tamoxifen: Tamoxifen citrate capsules"
237023|NCT01257581|P2|Participant Flow|Tamoxifen 40mg|"Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.
Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.
tamoxifen: Tamoxifen citrate capsules"
237024|NCT01257581|P1|Participant Flow|Creatine 30gm|"Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.
Creatine is a nutritional supplement and is not approved by the U.S. Food and Drug Administration (FDA) for treating ALS.
creatine: creatine monohydrate powder"
237025|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237026|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237027|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237028|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237029|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237030|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237031|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237032|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237033|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237034|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237035|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237036|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237037|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237038|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237039|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237073|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
237040|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237041|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237042|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237043|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237044|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237045|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237046|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237047|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237048|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
276226|NCT00083174|O2|Outcome|Placebo|Placebo tablet daily
237050|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237051|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237052|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237053|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237054|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237055|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237056|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237057|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237058|NCT01257581|E3|Reported Event|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237059|NCT01257581|E2|Reported Event|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
237060|NCT01257581|E1|Reported Event|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
237061|NCT01257542|B3|Baseline|Total|Total of all reporting groups
237062|NCT01257542|B2|Baseline|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
237063|NCT01257542|B1|Baseline|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
237064|NCT01257542|P2|Participant Flow|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
237065|NCT01257542|P1|Participant Flow|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
237066|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
237067|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
237068|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
237069|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
237070|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
237071|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
237072|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
237729|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237074|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
237075|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
237076|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
237077|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
237078|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
237079|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
237080|NCT01257542|E2|Reported Event|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
237081|NCT01257542|E1|Reported Event|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
237082|NCT01257503|B3|Baseline|Total|Total of all reporting groups
237083|NCT01257503|B2|Baseline|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
placebo: liquid made to look like the active homeopathic remedy"
237084|NCT01257503|B1|Baseline|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms
Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
237085|NCT01257503|P2|Participant Flow|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
placebo: liquid made to look like the active homeopathic remedy"
237086|NCT01257503|P1|Participant Flow|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms
Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
237088|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms
Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
237089|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
placebo: liquid made to look like the active homeopathic remedy"
237090|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms
Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
237091|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
placebo: liquid made to look like the active homeopathic remedy"
237092|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms
Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
237093|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
placebo: liquid made to look like the active homeopathic remedy"
237094|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms
Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
237095|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
placebo: liquid made to look like the active homeopathic remedy"
237096|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms
Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
237097|NCT01257503|E2|Reported Event|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
placebo: liquid made to look like the active homeopathic remedy"
237098|NCT01257503|E1|Reported Event|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms
Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
237099|NCT01257438|B3|Baseline|Total|Total of all reporting groups
237100|NCT01257438|B2|Baseline|PTA Only|PTA only: Treatment of in-stent restenosis
237101|NCT01257438|B1|Baseline|Fluency|"Fluency Plus Endovascular Stent Graft
Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
237102|NCT01257438|P2|Participant Flow|PTA Only|PTA only: Treatment of in-stent restenosis
237103|NCT01257438|P1|Participant Flow|Fluency|"Fluency Plus Endovascular Stent Graft
Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
237104|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
237105|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft
Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
237106|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
237107|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft
Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
237108|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
237109|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft
Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
237110|NCT01257438|E2|Reported Event|PTA Only|PTA only: Treatment of in-stent restenosis
237111|NCT01257438|E1|Reported Event|Fluency|"Fluency Plus Endovascular Stent Graft
Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
237112|NCT01257425|B3|Baseline|Total|Total of all reporting groups
237113|NCT01257425|B2|Baseline|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
237114|NCT01257425|B1|Baseline|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
237115|NCT01257425|P2|Participant Flow|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
237116|NCT01257425|P1|Participant Flow|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
237117|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
237118|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
237119|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
237120|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
237121|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
237122|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
237123|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
237124|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
237125|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
237126|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
237127|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
237128|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
239263|NCT01251315|E5|Reported Event|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group
237129|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
237130|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
237131|NCT01257425|E2|Reported Event|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
237132|NCT01257425|E1|Reported Event|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
237133|NCT01257347|B5|Baseline|Total|Total of all reporting groups
237134|NCT01257347|B4|Baseline|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
237135|NCT01257347|B3|Baseline|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
237136|NCT01257347|B2|Baseline|Electronically-measuring Adherence|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
237137|NCT01257347|B1|Baseline|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
237138|NCT01257347|P4|Participant Flow|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
237139|NCT01257347|P3|Participant Flow|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
237140|NCT01257347|P2|Participant Flow|Electronically-Measuring Adherence Intervention: Physicians|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment. 65 patients belonged to providers in the intervention group.
237141|NCT01257347|P1|Participant Flow|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.35 patients belonged to providers in the control group.
237156|NCT01257230|B2|Baseline|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237157|NCT01257230|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237158|NCT01257230|P3|Participant Flow|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler.
237142|NCT01257347|O2|Outcome|Electronically-measuring Adherence Group, Non-adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
237143|NCT01257347|O1|Outcome|Usual Care Control Group, Non-adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. Clinicians will be expected to manage hypertension according to usual care.
237144|NCT01257347|O2|Outcome|Electronically-measuring Adherence Group, Non-adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
237145|NCT01257347|O1|Outcome|Usual Care Control Group, Non-adherent Only|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
237174|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237175|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237146|NCT01257347|O2|Outcome|Electronically-measuring Adherence Group, Adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
237147|NCT01257347|O1|Outcome|Usual Care Control Group, Adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. Clinicians will be expected to manage hypertension according to usual care.
237148|NCT01257347|O2|Outcome|Electronically-measuring Adherence|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
237149|NCT01257347|O1|Outcome|Usual Care Control Group|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
237150|NCT01257347|E4|Reported Event|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
237151|NCT01257347|E3|Reported Event|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
237152|NCT01257347|E2|Reported Event|Electronically-Measuring Adherence Intervention: Physicians|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment. 65 patients belonged to providers in the intervention group.
237153|NCT01257347|E1|Reported Event|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care. 35 patients belonged to providers in the control group.
237154|NCT01257230|B4|Baseline|Total|Total of all reporting groups
237155|NCT01257230|B3|Baseline|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237159|NCT01257230|P2|Participant Flow|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237160|NCT01257230|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237161|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237162|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237163|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237164|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237165|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237166|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237167|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237168|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237169|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237170|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237171|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237172|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237173|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237176|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237177|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237178|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237179|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237180|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237181|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237182|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237183|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237184|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237185|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237186|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237187|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237188|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237189|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237190|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237191|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237192|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks delivered by the Respimat Inhaler
237193|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237194|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237195|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237196|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237197|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237198|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237199|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237200|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237201|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237202|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237203|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237204|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237205|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237206|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237207|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237208|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237209|NCT01257230|E3|Reported Event|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237210|NCT01257230|E2|Reported Event|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
237211|NCT01257230|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
237212|NCT01257217|B3|Baseline|Total|Total of all reporting groups
237213|NCT01257217|B2|Baseline|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
237214|NCT01257217|B1|Baseline|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
237215|NCT01257217|P2|Participant Flow|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
237216|NCT01257217|P1|Participant Flow|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
237217|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
237218|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
237219|NCT01257217|O4|Outcome|Acri.LISA/With|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
239264|NCT01251315|E4|Reported Event|Placebo-B|High dose group
237220|NCT01257217|O3|Outcome|Acri.LISA/Without|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
237221|NCT01257217|O2|Outcome|ReSTOR +3/With|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
237222|NCT01257217|O1|Outcome|ReSTOR +3/Without|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
237223|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
237224|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
237225|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
237226|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
237227|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
237228|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
237229|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
237230|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
237231|NCT01257217|E2|Reported Event|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL
237232|NCT01257217|E1|Reported Event|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
237233|NCT01257204|B4|Baseline|Total|Total of all reporting groups
237234|NCT01257204|B3|Baseline|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237235|NCT01257204|B2|Baseline|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237236|NCT01257204|B1|Baseline|Dacalatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
237237|NCT01257204|P3|Participant Flow|Placebo|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
237238|NCT01257204|P2|Participant Flow|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
237239|NCT01257204|P1|Participant Flow|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα­2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
237290|NCT01256424|P1|Participant Flow|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
237240|NCT01257204|O3|Outcome|Placebo: Follow-up|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks during treatment period and entered into the follow-up period.
237241|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks during treatment period and entered into the follow-up period.
237242|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
237243|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237244|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237245|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
237246|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237247|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237248|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
237249|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237250|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237251|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
237252|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 mcg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237253|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237254|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
237255|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237256|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237257|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
237258|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237259|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237260|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
237261|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237262|NCT01257204|O2|Outcome|Dacalatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237263|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
237338|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
237264|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237265|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237266|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
237267|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237268|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237269|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 week s.
237270|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237271|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237305|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
239265|NCT01251315|E3|Reported Event|Proimmune 200-A|Proimmune 200 low dose group
237272|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
237273|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
237274|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
237275|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
237276|NCT01257204|E6|Reported Event|Placebo: Follow-up|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks during treatment period and entered into the follow-up period.
237277|NCT01257204|E5|Reported Event|Daclatasvir, 60 mg, 16-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks during treatment period and entered into the follow-up period.
237278|NCT01257204|E4|Reported Event|Daclatasvir, 60 mg, 12-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
237279|NCT01257204|E3|Reported Event|Placebo|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
237280|NCT01257204|E2|Reported Event|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
237281|NCT01257204|E1|Reported Event|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
237282|NCT01256424|B5|Baseline|Total|Total of all reporting groups
237283|NCT01256424|B4|Baseline|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
237284|NCT01256424|B3|Baseline|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
237285|NCT01256424|B2|Baseline|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
237286|NCT01256424|B1|Baseline|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
237287|NCT01256424|P4|Participant Flow|Placebo Ointment Without Illumination|Treatment with a singe dose of 2g placebo ointment, no photoactivation
237288|NCT01256424|P3|Participant Flow|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
237289|NCT01256424|P2|Participant Flow|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
237416|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
237291|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
237292|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
237293|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
237294|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
237295|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
237296|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
237297|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
237298|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
237299|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
237300|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
237301|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
237302|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
237303|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
237304|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
237306|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
237307|NCT01256424|E4|Reported Event|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
237308|NCT01256424|E3|Reported Event|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
237309|NCT01256424|E2|Reported Event|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
237310|NCT01256424|E1|Reported Event|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
237311|NCT01256411|B5|Baseline|Total|Total of all reporting groups
237312|NCT01256411|B4|Baseline|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
237313|NCT01256411|B3|Baseline|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
237314|NCT01256411|B2|Baseline|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
237315|NCT01256411|B1|Baseline|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
237316|NCT01256411|P6|Participant Flow|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
237317|NCT01256411|P5|Participant Flow|LCZ696 Monotherapy|Participants received LCZ696 only.
237318|NCT01256411|P4|Participant Flow|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
237319|NCT01256411|P3|Participant Flow|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
237320|NCT01256411|P2|Participant Flow|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
237321|NCT01256411|P1|Participant Flow|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
237322|NCT01256411|O2|Outcome|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
237323|NCT01256411|O1|Outcome|LCZ696 Monotherapy|Participants received LCZ696 only.
237324|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
237325|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
237326|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
237327|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
237328|NCT01256411|O2|Outcome|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
237329|NCT01256411|O1|Outcome|LCZ696 Monotherapy|Participants received LCZ696 only.
237330|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
237331|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
237332|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
237333|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
237334|NCT01256411|O5|Outcome|LCZ696 100 mg|Participants were down-titrated to 100 mg.
237335|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
237336|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
237337|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
237339|NCT01256411|E5|Reported Event|LCZ696 400 mg/Aml/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
237340|NCT01256411|E4|Reported Event|LCZ696 400 mg/Aml|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
237341|NCT01256411|E3|Reported Event|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
237342|NCT01256411|E2|Reported Event|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
237343|NCT01256411|E1|Reported Event|LCZ696 100 mg|Participants were down-titrated to 100 mg.
237344|NCT01256385|B3|Baseline|Total|Total of all reporting groups
237345|NCT01256385|B2|Baseline|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
237346|NCT01256385|B1|Baseline|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
237347|NCT01256385|P2|Participant Flow|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
237348|NCT01256385|P1|Participant Flow|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
237349|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
237350|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
237351|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
237352|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
237353|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
237354|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
237355|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
237356|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
237357|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
237358|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
237359|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
237360|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
237361|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
237362|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
237363|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
237364|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
237365|NCT01256385|E2|Reported Event|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
237366|NCT01256385|E1|Reported Event|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
237367|NCT01256294|B1|Baseline|All Participants|"Period 1 (Days 1 through 14): Participants randomized to Sequence 1 took branded tacrolimus (Prograf) and participants randomized to Sequence 2 took generic tacrolimus (Sandoz).
Period 2 (Days 15 through 28): Participants randomized to Sequence 1 crossed over to treatment with generic tacrolimus and participants randomized to Sequence 2 crossed over to treatment with branded tacrolimus."
237368|NCT01256294|P2|Participant Flow|Sequence 2 - Generic Tacrolimus / Branded Tacrolimus|In Period 1 (Days 1-14) participants received generic tacrolimus (Sandoz) orally twice a day and in Period 2 (Days 15-28) participants received branded tacrolimus (Prograf) orally twice a day. Participants received the same stable dosage of tacrolimus dose they had been taking prior to enrollment (on a milligram for milligram basis).
237369|NCT01256294|P1|Participant Flow|Sequence 1 - Branded Tacrolimus / Generic Tacrolimus|In Period 1 (Days 1 - 14) participants received branded tacrolimus (Prograf) orally twice a day and in Period 2 (Days 15 - 28) participants received generic tacrolimus (Sandoz) orally twice a day. Participants received the same stable dosage of tacrolimus they had been taking prior to enrollment (on a milligram for milligram basis).
237370|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
237371|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
237372|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
237373|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
237374|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
237375|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
237376|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
237377|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
237378|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
237379|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
237380|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
237381|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
237382|NCT01256294|E2|Reported Event|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
276227|NCT00083174|O1|Outcome|Exemestane|25 mg of exemestane tablet daily
237383|NCT01256294|E1|Reported Event|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
237384|NCT01256281|B1|Baseline|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
237385|NCT01256281|P1|Participant Flow|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
237386|NCT01256281|O1|Outcome|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
237387|NCT01256281|E1|Reported Event|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
237388|NCT01256190|B3|Baseline|Total|Total of all reporting groups
237389|NCT01256190|B2|Baseline|Gelatin Sponge|approved device for surgical bleeding
237390|NCT01256190|B1|Baseline|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
237391|NCT01256190|P2|Participant Flow|Gelatin Sponge|approved device for surgical bleeding
237392|NCT01256190|P1|Participant Flow|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
237393|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
237394|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
237395|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
237396|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
237397|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
237398|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
237399|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
237400|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
237401|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
237402|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
237403|NCT01256190|E2|Reported Event|Gelatin Sponge|approved device for surgical bleeding
237404|NCT01256190|E1|Reported Event|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
237405|NCT01256177|B3|Baseline|Total|Total of all reporting groups
237406|NCT01256177|B2|Baseline|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
237407|NCT01256177|B1|Baseline|Placebo|Placebo matching Quetiapine XR.
237408|NCT01256177|P2|Participant Flow|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
237409|NCT01256177|P1|Participant Flow|Placebo|Placebo matching Quetiapine XR.
237410|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
237411|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
237412|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
237413|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
237414|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
237415|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
237417|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
237418|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
237419|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
237420|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
237421|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
237422|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
237423|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
237424|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
237425|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
237426|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
237427|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
237428|NCT01256177|E2|Reported Event|QUETIAPINE XR|
237429|NCT01256177|E1|Reported Event|PLACEBO|
237430|NCT01256164|B3|Baseline|Total|Total of all reporting groups
237431|NCT01256164|B2|Baseline|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
237432|NCT01256164|B1|Baseline|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
237646|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
237433|NCT01256164|P2|Participant Flow|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
237434|NCT01256164|P1|Participant Flow|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
237435|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
237436|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
237437|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
237438|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
237439|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
237440|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
237441|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
237442|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
237443|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
237444|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
237445|NCT01256164|E2|Reported Event|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
237446|NCT01256164|E1|Reported Event|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
237447|NCT01256086|B5|Baseline|Total|Total of all reporting groups
237448|NCT01256086|B4|Baseline|A2N2N1A1|Sequence 4: A2N2N1A1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
237449|NCT01256086|B3|Baseline|N2A1A2N1|Sequence 3: N2A1A2N1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
237450|NCT01256086|B2|Baseline|A1N1N2A2|Sequence 2: A1N1N2A2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
237451|NCT01256086|B1|Baseline|N1A2A1N2|Sequence 1: N1A2A1N2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
237452|NCT01256086|P4|Participant Flow|A2N2N1A1|Treatment sequence 24 µg Aerolizer - 24 µg Novolizer - 12 µg Novolizer - 12 µg Aerolizer
237453|NCT01256086|P3|Participant Flow|N2A1A2N1|Treatment sequence 24 µg Novolizer - 12 µg Aerolizer - 24 µg Aerolizer - 12 µg Novolizer
237454|NCT01256086|P2|Participant Flow|A1N1N2A2|Treatment sequence 12 µg Aerolizer - 12 µg Novolizer - 24 µg Novolizer - 24 µg Aerolizer
237455|NCT01256086|P1|Participant Flow|N1A2A1N2|Treatment sequence 12 µg Novolizer - 24 µg Aerolizer - 12 µg Aerolizer - 24 µg Novolizer
237456|NCT01256086|O4|Outcome|12µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
237457|NCT01256086|O3|Outcome|24 µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
237458|NCT01256086|O2|Outcome|12µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
237459|NCT01256086|O1|Outcome|24 µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
237460|NCT01256086|E4|Reported Event|12µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
237461|NCT01256086|E3|Reported Event|24 µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
237462|NCT01256086|E2|Reported Event|12µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
237463|NCT01256086|E1|Reported Event|24 µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
237464|NCT01256060|B1|Baseline|Intanasal Oxytocin|"A modified dose finding method was used to determine safety among four dose levels. Half the dose (0.2 IU/kg /dose) was the minimum dose and two intermediate doses were also evaluated (0.26 and 0.33 IU/kg / dose) Dose-finding escalations were done in groups of three patients.
Three patients were studied at the first dose level
If none of these patients experienced dose limiting toxicity, the dose was escalated.
If one patient experienced dose limiting toxicity, up to three more patients were accrued at the same level. (a) If none of these patients experienced dose limiting toxicity, the dose was escalated. (b) If one or more experienced dose-limiting toxicity, entry at that dose level would be stopped, the maximum tolerated dose exceeded, and dose escalation would be stopped. Up to three more patients would be treated at the next lower dose. If zero out of three patients experience dose limiting toxicity, an additional three patients were to be treated at that dose."
237465|NCT01256060|P4|Participant Flow|0.4 IU / kg|
237466|NCT01256060|P3|Participant Flow|0.33 IU / kg|
237467|NCT01256060|P2|Participant Flow|0.26 IU / kg|
237468|NCT01256060|P1|Participant Flow|0.2 IU / kg|
237469|NCT01256060|O1|Outcome|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin
237470|NCT01256060|O1|Outcome|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin
237471|NCT01256060|O1|Outcome|Intanasal Oxytocin|Number of Participants Experiencing a Serious Adverse Event
237472|NCT01256060|O1|Outcome|Intanasal Oxytocin|Cohort 1 Dosage: 0.20 IU/kg - 3 participants Cohort 2 Dosage: 0.26 IU/kg - 3 participants Cohort 3 Dosage: 0.33 IU/kg - 3 participants Cohort 4 Dosage: 0.40 IU/kg - 6 participants
237473|NCT01256060|E1|Reported Event|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin. Please note that the Adverse Events are not presented per dose level received, as this is not a dose-finding study, it is a modified maximum tolerated dose study. This means that a small number of participants were exposed to increasing dose levels to assess for Adverse Events. It is not meaningful to analyze adverse events by cohorts due to the extremely small sample size.
237474|NCT01256034|B3|Baseline|Total|Total of all reporting groups
237475|NCT01256034|B2|Baseline|Group B|ordinary diet
237476|NCT01256034|B1|Baseline|Group A|preoperative immunonutrition
237477|NCT01256034|P2|Participant Flow|Group B|ordinary diet
237478|NCT01256034|P1|Participant Flow|Group A|preoperative immunonutrition
237479|NCT01256034|O2|Outcome|Group B|ordinary diet
237480|NCT01256034|O1|Outcome|Group A|preoperative immunonutrition
237481|NCT01256034|E2|Reported Event|Group B|ordinary diet
237482|NCT01256034|E1|Reported Event|Group A|preoperative immunonutrition
237483|NCT01256008|B4|Baseline|Total|Total of all reporting groups
237484|NCT01256008|B3|Baseline|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
237485|NCT01256008|B2|Baseline|stage1 CBT|"The experimental group each session.
CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
237486|NCT01256008|B1|Baseline|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.
Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.
Following are major elements:
Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
237702|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237703|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237487|NCT01256008|P3|Participant Flow|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
237488|NCT01256008|P2|Participant Flow|Stage 1 CBT|"The experimental group will receive CBT each session.
CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
237489|NCT01256008|P1|Participant Flow|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.
Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.
Following are major elements:
Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
237490|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
237532|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237533|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
276228|NCT00083174|E2|Reported Event|Placebo|one tablet daily in am
237491|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.
CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
237492|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.
Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.
Following are major elements:
Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
237493|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
237494|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.
CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
237495|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.
Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.
Following are major elements:
Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
237496|NCT01256008|O3|Outcome|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
237497|NCT01256008|O2|Outcome|Stage 1 CBT|"The experimental group will receive CBT each session.
CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
237498|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.
Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.
Following are major elements:
Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
237499|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
237500|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.
CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
237501|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.
Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.
Following are major elements:
Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
237502|NCT01256008|O3|Outcome|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
237534|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
237647|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
237503|NCT01256008|O2|Outcome|Stage 1 CBT|"The experimental group will receive CBT each session.
CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
237504|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.
Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.
Following are major elements:
Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
237505|NCT01256008|E3|Reported Event|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
237506|NCT01256008|E2|Reported Event|stage1 CBT|"The experimental group will receive CBT each session.
CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
237507|NCT01256008|E1|Reported Event|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.
Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.
Following are major elements:
Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
237508|NCT01255904|B3|Baseline|Total|Total of all reporting groups
237509|NCT01255904|B2|Baseline|Oral Chloral Hydrate and Intranasal Placebo|
237510|NCT01255904|B1|Baseline|Oral Placebo and Intransal Dexmedetomidine|
237511|NCT01255904|P2|Participant Flow|Oral Chloral Hydrate and Intranasal Placebo|50 mg/kg oral chloral hydrate followed by intranasal placebo.
237512|NCT01255904|P1|Participant Flow|Oral Placebo and Intransal Dexmedetomidine|Oral placebo followed by Intranasal dexmedetomidine 3 mcg/kg (max dose 100 mcg).
237513|NCT01255904|O2|Outcome|Oral Chloral Hydrate and Intranasal Placebo|
237514|NCT01255904|O1|Outcome|Oral Placebo and Intransal Dexmedetomidine|
237515|NCT01255904|E2|Reported Event|Oral Chloral Hydrate and Intranasal Placebo|
237516|NCT01255904|E1|Reported Event|Oral Placebo and Intransal Dexmedetomidine|
237517|NCT01255787|B5|Baseline|Total|Total of all reporting groups
237518|NCT01255787|B4|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
237519|NCT01255787|B3|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237704|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237705|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237520|NCT01255787|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237521|NCT01255787|B1|Baseline|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
237522|NCT01255787|P4|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
237523|NCT01255787|P3|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237524|NCT01255787|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237525|NCT01255787|P1|Participant Flow|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
237526|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
237527|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237528|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237529|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
237530|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
237531|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237535|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237536|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237537|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
237538|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
237539|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237540|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237541|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
237542|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
237543|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237544|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237545|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
237546|NCT01255787|E4|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
237547|NCT01255787|E3|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237548|NCT01255787|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
237549|NCT01255787|E1|Reported Event|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
237550|NCT01255761|B3|Baseline|Total|Total of all reporting groups
237551|NCT01255761|B2|Baseline|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237552|NCT01255761|B1|Baseline|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237553|NCT01255761|P2|Participant Flow|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237554|NCT01255761|P1|Participant Flow|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237555|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237556|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237557|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237558|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237559|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237560|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237561|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237562|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237563|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237564|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237645|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
237565|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237566|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237567|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237568|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237569|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237570|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237571|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237572|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237573|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237574|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237575|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237576|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237577|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237578|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237579|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237580|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237706|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237707|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237581|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237582|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237583|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237584|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237585|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237586|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237587|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237588|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237589|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237590|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237591|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237592|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237593|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237594|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237595|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237596|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237597|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237598|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237599|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237600|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237601|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237602|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237603|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237604|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237605|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237606|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237607|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237608|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237609|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237610|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237611|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237612|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237613|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237614|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237615|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237616|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237617|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237618|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237619|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237620|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237621|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237622|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237623|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237624|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237625|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237626|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237627|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237628|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237629|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237630|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237631|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237632|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237633|NCT01255761|E2|Reported Event|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
237634|NCT01255761|E1|Reported Event|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
237635|NCT01255722|B4|Baseline|Total|Total of all reporting groups
237636|NCT01255722|B3|Baseline|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
237637|NCT01255722|B2|Baseline|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
237638|NCT01255722|B1|Baseline|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
237639|NCT01255722|P3|Participant Flow|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
237640|NCT01255722|P2|Participant Flow|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
237641|NCT01255722|P1|Participant Flow|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
237642|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
237643|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
237644|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
278871|NCT00095238|O4|Outcome|Placebo Baseline Class I or II|
237648|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
237649|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
237650|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
237651|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
237652|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
237653|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
237654|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
237655|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before coronary CT angiography
237656|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
237657|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
237658|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
237659|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
237660|NCT01255722|E3|Reported Event|Iomeprol|"Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
iomeprol: Single IV injection"
237661|NCT01255722|E2|Reported Event|Iopromide|"Patients were IV injected with a single dose of iopromide before a coronary CT angiography
iopromide: Single IV injection"
237662|NCT01255722|E1|Reported Event|Iobitridol|"Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
iobitridol: single IV injection"
237663|NCT01255631|B3|Baseline|Total|Total of all reporting groups
237664|NCT01255631|B2|Baseline|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
237665|NCT01255631|B1|Baseline|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
237666|NCT01255631|P2|Participant Flow|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
237667|NCT01255631|P1|Participant Flow|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
237708|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237709|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237710|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237711|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237712|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237713|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237714|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237715|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237668|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
237669|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
237670|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
237671|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
237672|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
237673|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
237674|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
237675|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
237676|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
237677|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
237678|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
237679|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
237680|NCT01255631|E2|Reported Event|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
237681|NCT01255631|E1|Reported Event|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
237682|NCT01255592|B3|Baseline|Total|Total of all reporting groups
237683|NCT01255592|B2|Baseline|Placebo|Placebo bd
237684|NCT01255592|B1|Baseline|AZD5069|AZD5069 80 mg bd
237685|NCT01255592|P2|Participant Flow|Placebo|Placebo for AZD5069, bd
237686|NCT01255592|P1|Participant Flow|AZD5069|AZD5069 80 mg bd
237687|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237688|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237689|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237690|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237691|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237692|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237693|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237694|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237695|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237696|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237697|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237698|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237699|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237700|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237701|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237730|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237731|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237732|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237733|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237734|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237735|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
237736|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237737|NCT01255592|O2|Outcome|Placebo|Placebo bd
237738|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
237739|NCT01255592|E2|Reported Event|Placebo|Placebo for AZD5069 bd
237740|NCT01255592|E1|Reported Event|AZD5069|80 mg bd
237741|NCT01255449|B1|Baseline|Albuterol|All recruited subjects underwent an acute bronchodilation with albuterol following baseline pulmonary function measurements.
237742|NCT01255449|P1|Participant Flow|Albuterol|On each study day, all lung function measurements were taken before and 30 min after inhaling four consecutive albuterol doses of 100 mcg each, through a valved-holding chamber. Lung diffusing capacity for carbon monoxide was measured only after bronchodilator inhalation.
237743|NCT01255449|O1|Outcome|Post-HSCT Changes in Lung Tissue Density|In eight out of 26 patients, a quantitative CT scan analysis was conducted to measure changes in lung tissue density
237744|NCT01255449|O1|Outcome|Airway Distensibility With Lung Inflation After HSCT|Changes in airway conductance at 5 Hz (Grs5) were related to changes in lung volume (DeltaGrs5/DeltaVL) to estimate airway distensibility
237745|NCT01255449|E1|Reported Event|Albuterol|All subjects underwent an acute bronchodilation with albuterol by inhaling four consecutive doses (100 mcg each)of the drug through a valved-holding chamber
237746|NCT01255436|B3|Baseline|Total|Total of all reporting groups
237747|NCT01255436|B2|Baseline|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
237748|NCT01255436|B1|Baseline|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
237749|NCT01255436|P2|Participant Flow|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
237750|NCT01255436|P1|Participant Flow|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
237751|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
237752|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
237753|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
237754|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
237755|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
237756|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
237757|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
237758|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
237759|NCT01255436|E2|Reported Event|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
237760|NCT01255436|E1|Reported Event|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
237761|NCT01255423|B3|Baseline|Total|Total of all reporting groups
237762|NCT01255423|B2|Baseline|Placebo|
237763|NCT01255423|B1|Baseline|Diclofenac Sodium Topical Gel 1%|
237764|NCT01255423|P2|Participant Flow|Placebo|
237765|NCT01255423|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|
237766|NCT01255423|O2|Outcome|Placebo|
237767|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
237768|NCT01255423|O2|Outcome|Placebo|
237769|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
237770|NCT01255423|O2|Outcome|Placebo|
237771|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
237772|NCT01255423|O2|Outcome|Placebo|
237773|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
237774|NCT01255423|O2|Outcome|Placebo|
237775|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
237776|NCT01255423|E2|Reported Event|Placebo|
237777|NCT01255423|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|
237778|NCT01255306|B3|Baseline|Total|Total of all reporting groups
237779|NCT01255306|B2|Baseline|RAISED IOP|Patients with raised IOP
237780|NCT01255306|B1|Baseline|NO IOP|Patients without raised IOP
237781|NCT01255306|P2|Participant Flow|RAISED IOP|Patients with raised IOP
237782|NCT01255306|P1|Participant Flow|NO IOP|Patients without raised IOP
237783|NCT01255306|O3|Outcome|CONTROL|Fellow eye of each patient
237784|NCT01255306|O2|Outcome|RAISED IOP|Patients with raised IOP
237785|NCT01255306|O1|Outcome|NO IOP|Patients without raised IOP
237786|NCT01255306|O2|Outcome|CONTROL EYES|Fellow eye of each patient
237787|NCT01255306|O1|Outcome|STUDY EYES|Study eyes that underwent pars plana vitrectomy and silicone oil tamponade
237788|NCT01255306|E2|Reported Event|CONTROL EYES|Fellow eye of each patient
237789|NCT01255306|E1|Reported Event|STUDY EYES|Study eyes that underwent pars plana vitrectomy and silicone oil tamponade
237790|NCT01255137|B1|Baseline|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.
Axitinib : 5 mg tab orally twice a day with food every 28 days"
237791|NCT01255137|P1|Participant Flow|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.
Axitinib : 5 mg tab orally twice a day with food every 28 days"
237792|NCT01255137|O1|Outcome|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.
Axitinib : 5 mg tab orally twice a day with food every 28 days"
237793|NCT01255137|O1|Outcome|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.
Axitinib : 5 mg tab orally twice a day with food every 28 days"
237835|NCT01254747|P2|Participant Flow|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237794|NCT01255137|E1|Reported Event|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.
Axitinib : 5 mg tab orally twice a day with food every 28 days"
237795|NCT01254890|B3|Baseline|Total|Total of all reporting groups
237796|NCT01254890|B2|Baseline|Phase II: Azacitidine + 400 Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle.
237797|NCT01254890|B1|Baseline|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
237798|NCT01254890|P2|Participant Flow|Phase II: Azacitidine + 400 mg Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle.
237842|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237799|NCT01254890|P1|Participant Flow|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
237800|NCT01254890|O1|Outcome|Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
237801|NCT01254890|O1|Outcome|Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
237802|NCT01254890|E2|Reported Event|Phase II: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 400 mg orally twice a day for 28 Day cycle.
237803|NCT01254890|E1|Reported Event|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
237804|NCT01254851|B3|Baseline|Total|Total of all reporting groups
237805|NCT01254851|B2|Baseline|Usual Care|routine post-operative ambulation
237806|NCT01254851|B1|Baseline|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
237807|NCT01254851|P2|Participant Flow|Usual Care|routine post-operative ambulation
237808|NCT01254851|P1|Participant Flow|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
237809|NCT01254851|O2|Outcome|Usual Care|routine post-operative ambulation
237810|NCT01254851|O1|Outcome|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
237811|NCT01254851|E2|Reported Event|Usual Care|routine post-operative ambulation
237812|NCT01254851|E1|Reported Event|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
237813|NCT01254760|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
237814|NCT01254760|P2|Participant Flow|Commercial Multifocal / Investigational Multifocal|Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
237815|NCT01254760|P1|Participant Flow|Investigational Multifocal / Commercial Multifocal|Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
237816|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
237817|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
237818|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn in bilaterally on a daily wear, daily disposable basis for 5 days
237819|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
237820|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
237821|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
237822|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
237823|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
237824|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
237825|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
237826|NCT01254760|E2|Reported Event|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days
237827|NCT01254760|E1|Reported Event|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days
237828|NCT01254747|B5|Baseline|Total|Total of all reporting groups
237829|NCT01254747|B4|Baseline|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237830|NCT01254747|B3|Baseline|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237831|NCT01254747|B2|Baseline|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237832|NCT01254747|B1|Baseline|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237833|NCT01254747|P4|Participant Flow|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237834|NCT01254747|P3|Participant Flow|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237836|NCT01254747|P1|Participant Flow|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237837|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237838|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237839|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237840|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237841|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
239266|NCT01251315|E2|Reported Event|N Acetyl Cysteine-A|N Acetyl cysteine low dose group
237843|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237844|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237845|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237846|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237847|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237848|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237849|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237850|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237851|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237852|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237853|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237854|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237855|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237856|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237857|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237858|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237859|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237860|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237861|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237862|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237863|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237864|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237865|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237866|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237867|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237868|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237869|NCT01254747|E4|Reported Event|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237870|NCT01254747|E3|Reported Event|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237871|NCT01254747|E2|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237872|NCT01254747|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
237873|NCT01254721|B3|Baseline|Total|Total of all reporting groups
237874|NCT01254721|B2|Baseline|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].
Treatment duration: 28 days"
237875|NCT01254721|B1|Baseline|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days"
237876|NCT01254721|P2|Participant Flow|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].
Treatment duration: 28 days"
237877|NCT01254721|P1|Participant Flow|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days"
237878|NCT01254721|O2|Outcome|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].
Treatment duration: 28 days"
294777|NCT00138203|B1|Baseline|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
237879|NCT01254721|O1|Outcome|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days"
237880|NCT01254721|O2|Outcome|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].
Treatment duration: 28 days"
237881|NCT01254721|O1|Outcome|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days"
237882|NCT01254721|E2|Reported Event|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].
Treatment duration: 28 days"
237883|NCT01254721|E1|Reported Event|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days"
237884|NCT01254669|B3|Baseline|Total|Total of all reporting groups
237885|NCT01254669|B2|Baseline|BNI/Intervention|One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one for immigration status .
237886|NCT01254669|B1|Baseline|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.
Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
237887|NCT01254669|P2|Participant Flow|Brief Negotiated Inteview (BNI) Intervention|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.
One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2) and one dropped out for fear information from study will affect her immigration status"
237888|NCT01254669|P1|Participant Flow|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve Human Papilloma Virus (HPV) vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.
Mothers assigned to the Control Group received the low-literacy, standard-practice, HPV vaccine information sheet usually given to all patients prior to vaccination. Control mothers met once with the research assistant to collect demographic characteristics, HPV knowledge, and vaccine status of the daughter on the day of visit. No Brief Negotiated Intervention (BNI) counseling was provided."
237889|NCT01254669|O2|Outcome|Control Group|Did not receive any BNI intervention on the pre and post measure
237890|NCT01254669|O1|Outcome|BNI Post-educational Intervention Group|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.
Post-educational interventional assessment of HPV knowledge ranges from 0(minimal knowledge) to 12 (maximal knowledge)"
237891|NCT01254669|O2|Outcome|BNI/Intervention|Intervention was administered to 100 African-American and Haitian mothers over 10-20 minutes prior to seeing the health provider if the daughter had never received the HPV vaccine, or after seeing the health provider if the daughter did not received the vaccine during the visit.
237892|NCT01254669|O1|Outcome|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.
Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), received the standard of care handout given to patients on the vaccine they will be getting that day. three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
237893|NCT01254669|E2|Reported Event|BNI/Intervention|One hundred mothers received intervention (n=50 Haitian, 50 African-American). . Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one due to fear of information affecting immigration status.
237894|NCT01254669|E1|Reported Event|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.
Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
237895|NCT01254656|B4|Baseline|Total|Total of all reporting groups
237896|NCT01254656|B3|Baseline|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237897|NCT01254656|B2|Baseline|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237898|NCT01254656|B1|Baseline|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
238378|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
237899|NCT01254656|P3|Participant Flow|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237900|NCT01254656|P2|Participant Flow|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237901|NCT01254656|P1|Participant Flow|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237902|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237903|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237904|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237905|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237906|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237907|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237908|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237909|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237910|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237911|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237912|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237913|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237914|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237915|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237916|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237917|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237918|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237919|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237920|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237921|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237922|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237923|NCT01254656|E3|Reported Event|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237924|NCT01254656|E2|Reported Event|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237925|NCT01254656|E1|Reported Event|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
237926|NCT01254643|B1|Baseline|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
237927|NCT01254643|P1|Participant Flow|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
237928|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
237929|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
237930|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
238487|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
237931|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
237932|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
237933|NCT01254643|E1|Reported Event|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
237934|NCT01254604|B3|Baseline|Total|Total of all reporting groups
237935|NCT01254604|B2|Baseline|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
237936|NCT01254604|B1|Baseline|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
237937|NCT01254604|P2|Participant Flow|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
239267|NCT01251315|E1|Reported Event|Placebo-A|low dose group
237938|NCT01254604|P1|Participant Flow|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
237939|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
237940|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
237941|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
237942|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
237943|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
237944|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
237945|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
237946|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
237947|NCT01254604|E2|Reported Event|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
237948|NCT01254604|E1|Reported Event|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
237949|NCT01254565|B7|Baseline|Total|Total of all reporting groups
237950|NCT01254565|B6|Baseline|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237951|NCT01254565|B5|Baseline|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237952|NCT01254565|B4|Baseline|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237953|NCT01254565|B3|Baseline|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237954|NCT01254565|B2|Baseline|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
237955|NCT01254565|B1|Baseline|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
237956|NCT01254565|P6|Participant Flow|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237957|NCT01254565|P5|Participant Flow|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237958|NCT01254565|P4|Participant Flow|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237959|NCT01254565|P3|Participant Flow|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237960|NCT01254565|P2|Participant Flow|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
237961|NCT01254565|P1|Participant Flow|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
237962|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237963|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237964|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237965|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237966|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
237967|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
238056|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
237968|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237969|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237970|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237971|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237972|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
237973|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
237974|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237975|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237976|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237977|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237978|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
237979|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
237980|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237981|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237982|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237983|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237984|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
237985|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
237986|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237987|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237988|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237989|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237990|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
237991|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
237992|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237993|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237994|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237995|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237996|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
237997|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
237998|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
237999|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
238000|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
238001|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
238002|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
238003|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
238004|NCT01254565|E6|Reported Event|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
238005|NCT01254565|E5|Reported Event|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
238006|NCT01254565|E4|Reported Event|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
238007|NCT01254565|E3|Reported Event|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
238008|NCT01254565|E2|Reported Event|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
238009|NCT01254565|E1|Reported Event|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
238010|NCT01254409|B5|Baseline|Total|Total of all reporting groups
238011|NCT01254409|B4|Baseline|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238012|NCT01254409|B3|Baseline|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238013|NCT01254409|B2|Baseline|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238014|NCT01254409|B1|Baseline|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238015|NCT01254409|P4|Participant Flow|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238016|NCT01254409|P3|Participant Flow|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238017|NCT01254409|P2|Participant Flow|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238018|NCT01254409|P1|Participant Flow|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238019|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238020|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238021|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238022|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238023|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238024|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238025|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238026|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238027|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238028|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238029|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238030|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238031|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238032|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238033|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238034|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238035|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238036|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238037|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238038|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238039|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238040|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238041|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238042|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238043|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238044|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238045|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238046|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238047|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238048|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238049|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238050|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238051|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238052|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238053|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238054|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238055|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238057|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238058|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238059|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238060|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238061|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238062|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238063|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238064|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238065|NCT01254409|E4|Reported Event|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238066|NCT01254409|E3|Reported Event|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238067|NCT01254409|E2|Reported Event|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238068|NCT01254409|E1|Reported Event|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
238069|NCT01254396|B1|Baseline|Entire Study Population|Includes groups randomized to receive sildenafil 50 mg ODT under fasted condition first and sildenafil 50 mg ODT under fed condition first.
238070|NCT01254396|P2|Participant Flow|Sildenafil Fed First, Then Sildenafil Fasted|Single oral dose of sildenafil 50 mg ODT under fed condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fasted condition in second intervention period. A washout period of at least 1 day was maintained between each period.
238071|NCT01254396|P1|Participant Flow|Sildenafil Fasted First, Then Sildenafil Fed|Single oral dose of sildenafil 50 milligram (mg) orally disintegrating tablet (ODT) under fasted condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fed condition in second intervention period. A washout period of at least 1 day was maintained between each period.
238072|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
238073|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
238074|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
238075|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
238076|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
238077|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
238078|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
238079|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
238080|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
238081|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
238082|NCT01254396|E2|Reported Event|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
238083|NCT01254396|E1|Reported Event|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
238084|NCT01254344|B3|Baseline|Total|Total of all reporting groups
238085|NCT01254344|B2|Baseline|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
238086|NCT01254344|B1|Baseline|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
238087|NCT01254344|P2|Participant Flow|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
238088|NCT01254344|P1|Participant Flow|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
238089|NCT01254344|O2|Outcome|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
238090|NCT01254344|O1|Outcome|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
238091|NCT01254344|O2|Outcome|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
238092|NCT01254344|O1|Outcome|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
238093|NCT01254344|E2|Reported Event|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
238094|NCT01254344|E1|Reported Event|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
238488|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238095|NCT01254331|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238096|NCT01254331|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the European League Against Rheumatism (EULAR) category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238097|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
239268|NCT01251276|B3|Baseline|Total|Total of all reporting groups
238098|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238099|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238100|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238101|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238102|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238103|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238104|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238105|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238106|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238107|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238108|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238109|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238110|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238111|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238112|NCT01254331|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
238113|NCT01254318|B1|Baseline|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem-cell transplantation.
238114|NCT01254318|P1|Participant Flow|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
238115|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
238116|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
238117|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
238118|NCT01254318|E1|Reported Event|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
238119|NCT01254305|B4|Baseline|Total|Total of all reporting groups
238120|NCT01254305|B3|Baseline|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
238121|NCT01254305|B2|Baseline|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
238122|NCT01254305|B1|Baseline|Placebo|"Matching placebo capsules, oral administration
Placebo : Matching placebo capsules, oral administration, once daily dosing"
238123|NCT01254305|P3|Participant Flow|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
238124|NCT01254305|P2|Participant Flow|Levomilnacipran ER|40 -120 mg Levomilnacipran ER capsules, oral administration once daily for 8 weeks.
238125|NCT01254305|P1|Participant Flow|Placebo|Matching placebo capsules, oral administration, once daily dosing.
238126|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
238127|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks.
238128|NCT01254305|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
238129|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
238130|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks
238131|NCT01254305|O1|Outcome|Placebo|Dose matched placebo capsules, oral administration for 8 weeks.
238132|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
238133|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration in capsule form, once daily for 8 weeks
238134|NCT01254305|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
238163|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238164|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238135|NCT01254305|E3|Reported Event|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
238136|NCT01254305|E2|Reported Event|Levomilnacipran ER|40 -120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
238137|NCT01254305|E1|Reported Event|Placebo|"Matching placebo capsules, oral administration
Placebo : Matching placebo capsules, oral administration, once daily dosing"
238138|NCT01254292|B3|Baseline|Total|Total of all reporting groups
238139|NCT01254292|B2|Baseline|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238140|NCT01254292|B1|Baseline|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238141|NCT01254292|P2|Participant Flow|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
239613|NCT01250418|B2|Baseline|No Ketamine|No ketamine added to anesthesia regimen
238142|NCT01254292|P1|Participant Flow|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238143|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238144|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238145|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238146|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238147|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238148|NCT01254292|O1|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238149|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238150|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238151|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238152|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238153|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238154|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238155|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238156|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238157|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238158|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238159|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238160|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238161|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238162|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238377|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
238165|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238166|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238167|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238168|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238169|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238449|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
238170|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238171|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238172|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238173|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238174|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238175|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238176|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238177|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238178|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238179|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238180|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238181|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238182|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238183|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238184|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238185|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238186|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238187|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238188|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238189|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238190|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238191|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238192|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
294898|NCT00138671|O2|Outcome|Subcutaneous Insulin|
238193|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
238194|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
238195|NCT01254292|E2|Reported Event|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 micron ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles.
238196|NCT01254292|E1|Reported Event|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 micron LNG per day for 18 months with optional extension to 36 months.
238197|NCT01254214|B3|Baseline|Total|Total of all reporting groups
238240|NCT01254045|E1|Reported Event|Intervention: Placebo 48IU|Two participants received placebo 48IU at baseline. Three participants received placebo 48IU at Time 2. Three participants received placebo 48IU at Time 3. This study is a cross-over design.
238241|NCT01253980|B3|Baseline|Total|Total of all reporting groups
238198|NCT01254214|B2|Baseline|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support
Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
238199|NCT01254214|B1|Baseline|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.
tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
238200|NCT01254214|P2|Participant Flow|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support
Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
238201|NCT01254214|P1|Participant Flow|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.
tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
238202|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support
Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
238203|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.
tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
238204|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support
Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
238205|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.
tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
238206|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support
Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
238207|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.
tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
238278|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
238279|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
294899|NCT00138671|O1|Outcome|Inhaled Insulin|
238208|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support
Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
238209|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.
tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
238210|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support
Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
238242|NCT01253980|B2|Baseline|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
238243|NCT01253980|B1|Baseline|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
238244|NCT01253980|P2|Participant Flow|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
238211|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.
tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
238212|NCT01254214|E2|Reported Event|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support
Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
238213|NCT01254214|E1|Reported Event|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.
tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
238214|NCT01254188|B1|Baseline|Nilotinib|Nilotinib 300 mg BID
238215|NCT01254188|P1|Participant Flow|Nilotinib|Nilotinib 300 mg BID
238216|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
238217|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
238218|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
238219|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
238220|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
238221|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
238222|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
238223|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
238224|NCT01254188|E1|Reported Event|Nilotinib|Nilotinib 300 mg BID
238225|NCT01254045|B1|Baseline|All Study Participants|Includes groups randomized to one of six different sequences of three interventions (placebo, oxytocin 24IU, oxytocin 48IU).
238226|NCT01254045|P6|Participant Flow|Placebo 48IU, Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU|intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
238227|NCT01254045|P5|Participant Flow|Oxytocin 48IU, Placebo 48IU, Oxytocin 24IU/Placebo 24IU|intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles ; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
238228|NCT01254045|P4|Participant Flow|Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU, Placebo 48IU|intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
238229|NCT01254045|P3|Participant Flow|Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU, Placebo 48IU|intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
238230|NCT01254045|P2|Participant Flow|Oxytocin 24IU/Placebo 24IU, Placebo 48IU, Oxytocin 48IU|intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
238231|NCT01254045|P1|Participant Flow|Placebo 48IU, Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU|intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
238232|NCT01254045|O3|Outcome|48IU OT|48 international units of intranasal oxytocin
238233|NCT01254045|O2|Outcome|24IU OT|24 international units of intranasal oxytocin and 24 IU of placebo
238234|NCT01254045|O1|Outcome|Placebo|placebo (48 IU)
238235|NCT01254045|O3|Outcome|48IU OT|48 international units of intranasal oxytocin
238236|NCT01254045|O2|Outcome|Oxytocin 24IU/Placebo 24IU|24 international units of intranasal oxytocin and 24 international units of placebo
238237|NCT01254045|O1|Outcome|Placebo|placebo (48IU)
238238|NCT01254045|E3|Reported Event|Intervention: Oxytocin 48IU|Three participants received Oxytocin 48IU at baseline. Two participants received Oxytocin 48IU at Time 2. Three participants received Oxytocin 48IU at Time 3. This study is a cross-over design.
238239|NCT01254045|E2|Reported Event|Intervention: Oxytocin 24IU/Placebo 24IU|Three participants received Oxytocin 24IU/Placebo 24IU at baseline. Three participants received Oxytocin 24IU/Placebo 24IU at Time 2. Two participants received Oxytocin 24IU/Placebo 24IU at Time 3. This study is a cross-over design.
238245|NCT01253980|P1|Participant Flow|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
238246|NCT01253980|O2|Outcome|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
238251|NCT01253902|B3|Baseline|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238252|NCT01253902|B2|Baseline|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
238253|NCT01253902|B1|Baseline|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238254|NCT01253902|P3|Participant Flow|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238255|NCT01253902|P2|Participant Flow|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
238256|NCT01253902|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238257|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238258|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
238259|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238260|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238261|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
238262|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238263|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238264|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
238265|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238266|NCT01253902|E3|Reported Event|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238267|NCT01253902|E2|Reported Event|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
238268|NCT01253902|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
238269|NCT01253824|B3|Baseline|Total|Total of all reporting groups
238270|NCT01253824|B2|Baseline|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
238271|NCT01253824|B1|Baseline|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
238272|NCT01253824|P2|Participant Flow|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
238273|NCT01253824|P1|Participant Flow|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
238274|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
238275|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
238276|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
238277|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
238280|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
238281|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
238282|NCT01253824|E2|Reported Event|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
238283|NCT01253824|E1|Reported Event|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol
NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
238284|NCT01253811|B1|Baseline|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238320|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
278872|NCT00095238|O3|Outcome|Irbesartan Baseline All Classes Combined|
238285|NCT01253811|P1|Participant Flow|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238286|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238287|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238288|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238289|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238290|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238291|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238292|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238293|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238313|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238294|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238295|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238296|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238448|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
238297|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238298|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238299|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238300|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238301|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238302|NCT01253811|E1|Reported Event|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
238303|NCT01253577|B1|Baseline|Sinus Stent|Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
238304|NCT01253577|P1|Participant Flow|Sinus Stent|Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
238305|NCT01253577|O2|Outcome|Non-coated Implant Side|Sinus stent without drug coating
238306|NCT01253577|O1|Outcome|Drug-Coated Implant Side|Sinus stent coated with steroid
238307|NCT01253577|O1|Outcome|All Subjects|
238308|NCT01253577|O2|Outcome|Non-coated Implant Side|Sinus stent without drug coating
238309|NCT01253577|O1|Outcome|Drug-Coated Implant Side|Sinus stent coated with steroid
238310|NCT01253577|E1|Reported Event|All Patients|Patients served as their own controls in the study, with a drug-coated stent placed on one sinus side and a non-drug-coated control placed on contralateral side. Therefore adverse events are listed for the entire 105-patient cohort rather than by treatment group.
238311|NCT01253564|B1|Baseline|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238312|NCT01253564|P1|Participant Flow|Vemurafenib|Participants received vemurafenib tablets, 960 milligrams (mg), twice daily (BID), orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238314|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238315|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238316|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238317|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238318|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238319|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238321|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238322|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238323|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238324|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238325|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238326|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238327|NCT01253564|E1|Reported Event|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
238328|NCT01253525|B1|Baseline|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238329|NCT01253525|P1|Participant Flow|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238330|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238331|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238332|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238333|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238334|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238335|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238336|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238337|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238338|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238339|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238340|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238341|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238342|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238343|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238344|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238345|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238450|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
238346|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238347|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238348|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238349|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238350|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238351|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238352|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238353|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238354|NCT01253525|E1|Reported Event|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
238355|NCT01253447|B1|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
238356|NCT01253447|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
238357|NCT01253447|O1|Outcome|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
238358|NCT01253447|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
238359|NCT01253408|B4|Baseline|Total|Total of all reporting groups
238360|NCT01253408|B3|Baseline|Placebo|Placebo will be taken orally with water twice per day for two days.
238361|NCT01253408|B2|Baseline|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
238362|NCT01253408|B1|Baseline|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
238363|NCT01253408|P3|Participant Flow|Placebo|Placebo will be taken orally with water twice per day for two days.
238364|NCT01253408|P2|Participant Flow|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
238365|NCT01253408|P1|Participant Flow|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
238366|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
238367|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
238368|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
238369|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
238370|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
238371|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
238372|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
238373|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
238374|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
238375|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
238376|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
294900|NCT00138671|O2|Outcome|Subcutaneous Insulin|
238379|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
238380|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
238381|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
238382|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
238383|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
238384|NCT01253408|E3|Reported Event|Placebo|Placebo will be taken orally with water twice per day for two days.
238385|NCT01253408|E2|Reported Event|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
238386|NCT01253408|E1|Reported Event|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
238387|NCT01253369|B1|Baseline|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
238497|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238388|NCT01253369|P1|Participant Flow|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
238389|NCT01253369|O1|Outcome|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
238390|NCT01253369|O1|Outcome|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
238391|NCT01253369|E1|Reported Event|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
238392|NCT01253343|B3|Baseline|Total|Total of all reporting groups
238393|NCT01253343|B2|Baseline|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score ≤6.5.
238394|NCT01253343|B1|Baseline|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score ≥ 8.
238395|NCT01253343|P2|Participant Flow|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score <7.5.
238396|NCT01253343|P1|Participant Flow|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score >7.5.
238397|NCT01253343|O12|Outcome|High Aggression Group + TestosteroneSample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
238398|NCT01253343|O11|Outcome|High Aggression Group + TestosteroneSample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
238399|NCT01253343|O10|Outcome|High Aggression Group + TestosteroneSample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
238400|NCT01253343|O9|Outcome|High Aggression Group + DHEASample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
238401|NCT01253343|O8|Outcome|High Aggression Group + DHEASample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
238402|NCT01253343|O7|Outcome|High Aggression Group + DHEASample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
238403|NCT01253343|O6|Outcome|Low Aggression Group + TestosteroneSample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
238404|NCT01253343|O5|Outcome|Low Aggression Group + TestosteroneSample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
238405|NCT01253343|O4|Outcome|Low Aggression Group + TestosteroneSample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
238406|NCT01253343|O3|Outcome|Low Aggression Group + DHEA Sample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
238407|NCT01253343|O2|Outcome|Low Aggression Group + DHEA Sample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
238408|NCT01253343|O1|Outcome|Low Aggression Group + DHEA Sample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
238409|NCT01253343|O6|Outcome|High Aggression Group + Cortisol Sample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
238410|NCT01253343|O5|Outcome|High Aggression Group + Cortisol Sample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
238411|NCT01253343|O4|Outcome|High Aggression Group + Cortisol Sample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
238412|NCT01253343|O3|Outcome|Low Aggression Group + Cortisol Sample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
238413|NCT01253343|O2|Outcome|Low Aggression Group + Cortisol Sample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
238414|NCT01253343|O1|Outcome|Low Aggression Group + Cortisol Sample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
238415|NCT01253343|E2|Reported Event|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score <7.5.
238416|NCT01253343|E1|Reported Event|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score >7.5.
238437|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
238438|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
238439|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
238417|NCT01253317|B1|Baseline|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.
10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
238418|NCT01253317|P1|Participant Flow|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.
10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
280415|NCT00089661|E2|Reported Event|Denosumab 60 mg Q6M|
238419|NCT01253317|O1|Outcome|20-week Open Label Extension (OLE)|10 subjects that previously participated in the MAD went on to complete the OLE and were monitored for safety of prolonged treatment (20 weeks).
238420|NCT01253317|O1|Outcome|MAD and OLE Treatment Periods|Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, and evaluating safety and tolerability of IGF-1. Ten subjects that previously participated in the MAD went on to complete the OLE and were monitoring for safety of prolonged treatment (20 weeks).
238421|NCT01253317|O1|Outcome|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.
10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
238422|NCT01253317|O2|Outcome|20-week Open Label Extension (OLE)|10 subjects that previously participated in the MAD went on to complete the OLE and were monitoring for safety of prolonged treatment (20 weeks).
238423|NCT01253317|O1|Outcome|4-week Multiple Ascending Dose (MAD)|Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, and evaluating safety and tolerability of IGF-1.
238424|NCT01253317|E1|Reported Event|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.
10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
238425|NCT01253304|B5|Baseline|Total|Total of all reporting groups
238426|NCT01253304|B4|Baseline|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
238427|NCT01253304|B3|Baseline|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
238428|NCT01253304|B2|Baseline|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
238429|NCT01253304|B1|Baseline|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
238430|NCT01253304|P4|Participant Flow|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
238431|NCT01253304|P3|Participant Flow|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
238432|NCT01253304|P2|Participant Flow|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
238433|NCT01253304|P1|Participant Flow|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
238434|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
238435|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
238436|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
238440|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
238441|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
238442|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
238443|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
238444|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
238445|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
238446|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
238447|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
238451|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
238452|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
238453|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
238454|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
238455|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
238456|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
238457|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
238458|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
238459|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
238460|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
238461|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
238462|NCT01253304|E4|Reported Event|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
238463|NCT01253304|E3|Reported Event|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
238464|NCT01253304|E2|Reported Event|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
238465|NCT01253304|E1|Reported Event|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
238466|NCT01253265|B6|Baseline|Total|Total of all reporting groups
238467|NCT01253265|B5|Baseline|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
238468|NCT01253265|B4|Baseline|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
238469|NCT01253265|B3|Baseline|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238470|NCT01253265|B2|Baseline|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238471|NCT01253265|B1|Baseline|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238472|NCT01253265|P5|Participant Flow|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
238473|NCT01253265|P4|Participant Flow|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
238474|NCT01253265|P3|Participant Flow|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238475|NCT01253265|P2|Participant Flow|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238476|NCT01253265|P1|Participant Flow|30 Milligram (mg) LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238477|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
238478|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238479|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238480|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238481|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
238482|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238483|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238484|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238485|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
238486|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
294901|NCT00138671|O1|Outcome|Inhaled Insulin|
238489|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
238490|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
238491|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238492|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238493|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238494|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
238495|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
238496|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
280416|NCT00089661|E1|Reported Event|Placebo|
238499|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
238500|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
238501|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238502|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238503|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238504|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
238505|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
238506|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238507|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238508|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238509|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
238510|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
238511|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238512|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238513|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238514|NCT01253265|E5|Reported Event|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
238515|NCT01253265|E4|Reported Event|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
238516|NCT01253265|E3|Reported Event|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238517|NCT01253265|E2|Reported Event|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238518|NCT01253265|E1|Reported Event|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
238519|NCT01253187|B1|Baseline|Entire Study Population|Includes all participants treated
238520|NCT01253187|P6|Participant Flow|Treatment Sequence F: Metafolin, EE20/DRSP/L-5-MTHF Ca, YAZ|Metafolin for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; YAZ for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP).
238521|NCT01253187|P5|Participant Flow|Treatment Sequence E: Metafolin, YAZ, EE20/DRSP/L-5-MTHF Ca|Metafolin for Period 1; YAZ for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
238522|NCT01253187|P4|Participant Flow|Treatment Sequence D: EE20/DRSP/L-5-MTHF Ca, Metafolin, YAZ|EE20/DRSP/L-5-MTHF Ca for Period 1; Metafolin for Period 2; YAZ for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP).
238523|NCT01253187|P3|Participant Flow|Treatment Sequence C: EE20/DRSP/L-5-MTHF Ca, YAZ, Metafolin|EE20/DRSP/L-5-MTHF Ca for Period 1; YAZ for Period 2; Metafolin for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
238548|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238695|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
238524|NCT01253187|P2|Participant Flow|Treatment Sequence B: YAZ, Metafolin, EE20/DRSP/L-5-MTHF Ca|YAZ for Period 1; Metafolin for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
238525|NCT01253187|P1|Participant Flow|Treatment Sequence A: YAZ, EE20/DRSP/L-5-MTHF Ca, Metafolin|YAZ for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; Metafolin for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
238526|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238710|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
280417|NCT00089674|B3|Baseline|Total|Total of all reporting groups
238527|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
238528|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238529|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
238530|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238531|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
238532|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238533|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
238534|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238535|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238536|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238537|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238538|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238539|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238540|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium) [L-5-MTHF Ca]
238541|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238542|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238543|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
238544|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238545|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
238546|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238547|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
238696|NCT01252810|E2|Reported Event|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration. Up to 7 days post Ioforminol administration.
238549|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
238550|NCT01253187|E3|Reported Event|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
238551|NCT01253187|E2|Reported Event|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
238552|NCT01253187|E1|Reported Event|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
238553|NCT01253174|B1|Baseline|Entire Study Population|Includes all participants treated
238571|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238572|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238554|NCT01253174|P6|Participant Flow|Treatment Sequence F: Metafolin, EE30/DRSP/L-5-MTHF Ca, Yasmin|Metafolin for Period 1; EE30/DRSP/L-5-MTHF Ca for Period 2; Yasmin for Period 3. Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP).
238555|NCT01253174|P5|Participant Flow|Treatment Sequence E: Metafolin, Yasmin, EE30/DRSP/L-5-MTHF Ca|Metafolin for Period 1; Yasmin for Period 2; EE30/DRSP/L-5-MTHF Ca for Period 3. Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
238556|NCT01253174|P4|Participant Flow|Treatment Sequence D: EE30/DRSP/L-5-MTHF Ca, Metafolin, Yasmin|EE30/DRSP/L-5-MTHF Ca for Period 1; Metafolin for Period 2; Yasmin for Period 3. EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP).
238557|NCT01253174|P3|Participant Flow|Treatment Sequence C: EE30/DRSP/L-5-MTHF Ca, Yasmin, Metafolin|EE30/DRSP/L-5-MTHF Ca for Period 1; Yasmin for Period 2; Metafolin for Period 3. EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
238558|NCT01253174|P2|Participant Flow|Treatment Sequence B: Yasmin, Metafolin, EE30/DRSP/L-5-MTHF Ca|Yasmin for Period 1; Metafolin for Period 2; EE30/DRSP/L-5-MTHF Ca for Period 3. Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
238559|NCT01253174|P1|Participant Flow|Treatment Sequence A: Yasmin, EE30/DRSP/L-5-MTHF Ca, Metafolin|Yasmin for Period 1; EE30/DRSP/L-5-MTHF Ca for Period 2; Metafolin for Period 3. Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
238560|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238561|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238562|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238563|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
238564|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238936|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
238565|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
238566|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238567|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
238568|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238569|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238570|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
241467|NCT01244620|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days
238573|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238574|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238575|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238576|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238577|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
238578|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238579|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
238580|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238581|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
238582|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238583|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
238584|NCT01253174|E3|Reported Event|L-5-MTHF Ca 0.451mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238585|NCT01253174|E2|Reported Event|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
238586|NCT01253174|E1|Reported Event|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
238587|NCT01253148|B1|Baseline|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
238588|NCT01253148|P1|Participant Flow|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
238589|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
238590|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
238631|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
238591|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
238592|NCT01253148|E1|Reported Event|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
238593|NCT01253135|B1|Baseline|All Participants|The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.
238611|NCT01253044|B2|Baseline|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
238711|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238594|NCT01253135|P1|Participant Flow|All Participants|The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.
238595|NCT01253135|O2|Outcome|Control|"White Petrolatum
White Petrolatum: Topical application
White petrolatum was applied daily to the appropriate wound."
238596|NCT01253135|O1|Outcome|Test Article|"802-247 Vehicle (fibrinogen)
Fibrin: Topical application of fibrinogen spray, followed by thrombin spray
HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
238597|NCT01253135|O2|Outcome|Test Article|"802-247 Vehicle (fibrinogen)
Fibrin: Topical application of fibrinogen spray, followed by thrombin spray
HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
238598|NCT01253135|O1|Outcome|Control|"White Petrolatum
White Petrolatum: Topical application
White petrolatum was applied daily to the appropriate wound."
238599|NCT01253135|E2|Reported Event|Test Article|"802-247 Vehicle (fibrinogen)
Fibrin: Topical application of fibrinogen spray, followed by thrombin spray
HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
238600|NCT01253135|E1|Reported Event|Control|"White Petrolatum
White Petrolatum: Topical application
White petrolatum was applied daily to the appropriate wound."
238601|NCT01253070|B1|Baseline|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
238602|NCT01253070|P1|Participant Flow|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
238603|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
238604|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
238605|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
238659|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238937|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
238606|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
238607|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
238608|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
238609|NCT01253070|E1|Reported Event|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
238610|NCT01253044|B3|Baseline|Total|Total of all reporting groups
238612|NCT01253044|B1|Baseline|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
238613|NCT01253044|P2|Participant Flow|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
238614|NCT01253044|P1|Participant Flow|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
238615|NCT01253044|O2|Outcome|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
238616|NCT01253044|O1|Outcome|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
238617|NCT01253044|O2|Outcome|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
238618|NCT01253044|O1|Outcome|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
238619|NCT01253044|E2|Reported Event|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
238620|NCT01253044|E1|Reported Event|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
238621|NCT01253018|B3|Baseline|Total|Total of all reporting groups
238622|NCT01253018|B2|Baseline|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)
238623|NCT01253018|B1|Baseline|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
238624|NCT01253018|P2|Participant Flow|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
238625|NCT01253018|P1|Participant Flow|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using 2 different robots in a sequential 4 week progression in 3 distinct modules: wrist, shoulder-elbow and alternating sessions of wrist and shoulder-elbow robot. Sessions were 3x/week x 60 minutes.
238626|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
238627|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
238628|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
238629|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
238630|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)
238693|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
238632|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
238633|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
238634|NCT01253018|E2|Reported Event|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
238635|NCT01253018|E1|Reported Event|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
238636|NCT01252966|B3|Baseline|Total|Total of all reporting groups
238637|NCT01252966|B2|Baseline|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238638|NCT01252966|B1|Baseline|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238708|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238639|NCT01252966|P2|Participant Flow|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238640|NCT01252966|P1|Participant Flow|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238641|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238642|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238643|NCT01252966|O2|Outcome|Control Training|The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function.
238644|NCT01252966|O1|Outcome|Cognitive Training|The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.
238645|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238646|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238647|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238648|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238649|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238650|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
238651|NCT01252966|E2|Reported Event|Control Training|
238652|NCT01252966|E1|Reported Event|Cognitive Training|
238653|NCT01252940|B3|Baseline|Total|Total of all reporting groups
238654|NCT01252940|B2|Baseline|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238655|NCT01252940|B1|Baseline|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238656|NCT01252940|P2|Participant Flow|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238657|NCT01252940|P1|Participant Flow|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.
238658|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238694|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
238660|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238661|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238662|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238663|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238664|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238665|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238666|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238667|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238709|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238668|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238669|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238670|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238671|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238672|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238673|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238674|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238675|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238676|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238677|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238678|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238679|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238680|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238681|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238682|NCT01252940|E3|Reported Event|SBR/Delayed Switch (After Week 24)|The adverse events reported in this group are those that occurred after Week 24 in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at Week 24 visit.
238683|NCT01252940|E2|Reported Event|SBR/Delayed Switch (up to Week 24)|The adverse events reported in this group are those that occurred in the first 24 weeks of the study in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
238684|NCT01252940|E1|Reported Event|FTC/RPV/TDF|The adverse events reported in this group are those that occurred at any time during the study in participants who were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
238685|NCT01252810|B3|Baseline|Total|Total of all reporting groups
238686|NCT01252810|B2|Baseline|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
238687|NCT01252810|B1|Baseline|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
238688|NCT01252810|P2|Participant Flow|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
238689|NCT01252810|P1|Participant Flow|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
238690|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
238691|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
238692|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
294902|NCT00138671|O2|Outcome|Subcutaneous Insulin|
238697|NCT01252810|E1|Reported Event|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration. Up to 7 days post Iopamidol administration.
238698|NCT01252355|B4|Baseline|Total|Total of all reporting groups
238699|NCT01252355|B3|Baseline|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238700|NCT01252355|B2|Baseline|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238701|NCT01252355|B1|Baseline|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238702|NCT01252355|P3|Participant Flow|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238703|NCT01252355|P2|Participant Flow|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238704|NCT01252355|P1|Participant Flow|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238705|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238706|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238707|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238712|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238713|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238714|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238715|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238716|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238717|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238718|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238719|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238720|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238721|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238722|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238723|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238724|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238725|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238726|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238727|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238728|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238729|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238730|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238731|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238732|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238733|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238734|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238735|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238736|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238737|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238738|NCT01252355|E3|Reported Event|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
238739|NCT01252355|E2|Reported Event|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
238740|NCT01252355|E1|Reported Event|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
238741|NCT01252290|B1|Baseline|Lovaza™|Lovaza™: 4 capsules daily for 6 months
238742|NCT01252290|P1|Participant Flow|Lovaza™|Lovaza™: 4 capsules daily for 6 months
238743|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
238744|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
238745|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
238746|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
238747|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
238748|NCT01252290|E1|Reported Event|Lovaza™|Lovaza™: 4 capsules daily for 6 months
238749|NCT01252277|B1|Baseline|Lovaza™|Lovaza™ (two 1 gram capsules twice daily) for six months
238750|NCT01252277|P1|Participant Flow|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
238751|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
238752|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
238753|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
238754|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
238755|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
238756|NCT01252277|E1|Reported Event|Lovaza™|"Lovaza™ (two 1 gram capsules twice daily) for six months
Lovaza™: 4 capsules daily for 6 months"
238938|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
238757|NCT01252251|B1|Baseline|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
238758|NCT01252251|P1|Participant Flow|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
238759|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
238876|NCT01252134|E3|Reported Event|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
241732|NCT01243450|P1|Participant Flow|Active Generic|"active cream
Tretinoin: Topical skin"
238760|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
238761|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
238762|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
238763|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
238764|NCT01252251|O1|Outcome|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
238765|NCT01252251|E1|Reported Event|RAD001 and Pasireotide LAR|"This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
RAD001 (Everolimus) and Pasireotide (SOM230) LAR: Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42."
238766|NCT01252238|B4|Baseline|Total|Total of all reporting groups
238767|NCT01252238|B3|Baseline|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)
Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
238768|NCT01252238|B2|Baseline|Placebo Group|"Only taking Amlodipine
Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
238769|NCT01252238|B1|Baseline|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
238770|NCT01252238|P3|Participant Flow|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)
Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
238771|NCT01252238|P2|Participant Flow|Placebo Group|"Only taking Amlodipine
Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
238772|NCT01252238|P1|Participant Flow|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
238773|NCT01252238|O3|Outcome|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)
Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
238774|NCT01252238|O2|Outcome|Placebo Group|"Only taking Amlodipine
Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
238775|NCT01252238|O1|Outcome|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
238776|NCT01252238|E3|Reported Event|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)
Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
238777|NCT01252238|E2|Reported Event|Placebo Group|"Only taking Amlodipine
Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
238778|NCT01252238|E1|Reported Event|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
238779|NCT01252186|B4|Baseline|Total|Total of all reporting groups
238780|NCT01252186|B3|Baseline|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238781|NCT01252186|B2|Baseline|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238939|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
238782|NCT01252186|B1|Baseline|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238783|NCT01252186|P3|Participant Flow|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238784|NCT01252186|P2|Participant Flow|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238785|NCT01252186|P1|Participant Flow|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238786|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238787|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238788|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238789|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238790|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238791|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238792|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238793|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238794|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238795|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238796|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238797|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238798|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238799|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238800|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238801|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238802|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238803|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238804|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238805|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238806|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238940|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
238941|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm
238807|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238808|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238809|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238810|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238811|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238812|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238877|NCT01252134|E2|Reported Event|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
241733|NCT01243450|O3|Outcome|Brand|Tretinoin: Topical skin
238813|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238814|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238815|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238816|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238817|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238818|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238819|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238820|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238821|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238822|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238823|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238824|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238825|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238826|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238827|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238828|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238829|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238830|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238831|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238942|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
238832|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238833|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238834|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238835|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238836|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238837|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238838|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238839|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238840|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238841|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238842|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238843|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238844|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238845|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238846|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238847|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238848|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238849|NCT01252186|E3|Reported Event|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238850|NCT01252186|E2|Reported Event|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
238851|NCT01252186|E1|Reported Event|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
238852|NCT01252147|B1|Baseline|All Participants|
238853|NCT01252147|P1|Participant Flow|All Participants|
238854|NCT01252147|O1|Outcome|All Participants|
238855|NCT01252147|O1|Outcome|All Participants|
238856|NCT01252147|E1|Reported Event|All Participants|
238857|NCT01252134|B1|Baseline|Overall|All enrolled participants
238858|NCT01252134|P6|Participant Flow|OTE, Then Synergi, Then Biotrue|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
238859|NCT01252134|P5|Participant Flow|OTE, Then Biotrue, Then Synergi|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
238860|NCT01252134|P4|Participant Flow|Biotrue, Then Synergi, Then OTE|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
238861|NCT01252134|P3|Participant Flow|Biotrue, Then OTE, Then Synergi|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
238943|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
238944|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
238862|NCT01252134|P2|Participant Flow|Synergi, Then OTE, Then Biotrue|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
238863|NCT01252134|P1|Participant Flow|Synergi, Then Biotrue, Then OTE|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
238864|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238865|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238866|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238867|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238868|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238869|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238870|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238871|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238872|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238873|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238874|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238875|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238878|NCT01252134|E1|Reported Event|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
238879|NCT01252095|B3|Baseline|Total|Total of all reporting groups
238880|NCT01252095|B2|Baseline|50 mg Dose|50 mg PG545/week
238881|NCT01252095|B1|Baseline|25 mg Dose|25 mg PG545/week
238882|NCT01252095|P2|Participant Flow|50 mg Dose|50 mg PG545/week
238883|NCT01252095|P1|Participant Flow|25 mg Dose|25 mg PG545/week
238884|NCT01252095|O2|Outcome|50 mg Dose|50 mg PG545/week
238885|NCT01252095|O1|Outcome|25 mg Dose|25 mg PG545/week
238886|NCT01252095|E2|Reported Event|50 mg Dose|50 mg PG545/week
238887|NCT01252095|E1|Reported Event|25 mg Dose|25 mg PG545/week
238888|NCT01251978|B3|Baseline|Total|Total of all reporting groups
238889|NCT01251978|B2|Baseline|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
238890|NCT01251978|B1|Baseline|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
238891|NCT01251978|P2|Participant Flow|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
238892|NCT01251978|P1|Participant Flow|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
238893|NCT01251978|O2|Outcome|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
238894|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
238895|NCT01251978|O2|Outcome|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
238896|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
238897|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
238898|NCT01251978|E2|Reported Event|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
238899|NCT01251978|E1|Reported Event|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
238900|NCT01251952|B1|Baseline|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.
Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
238901|NCT01251952|P1|Participant Flow|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.
Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
238902|NCT01251952|O1|Outcome|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.
Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
238945|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
239202|NCT01251588|E1|Reported Event|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
238903|NCT01251952|E1|Reported Event|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.
Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
238904|NCT01251770|B3|Baseline|Total|Total of all reporting groups
238905|NCT01251770|B2|Baseline|ClNa 0.45%|maintenance solution with ClNa 0.45%
238906|NCT01251770|B1|Baseline|ClNa 0.3%|maintenance solution with ClNa 0.3%
238907|NCT01251770|P2|Participant Flow|ClNa 0.45%|maintenance solution with ClNa 0.45%
238908|NCT01251770|P1|Participant Flow|ClNa 0.3%|maintenance solution with ClNa 0.3%
238909|NCT01251770|O2|Outcome|ClNa 0.45%|maintenance solution with ClNa 0.45%
238910|NCT01251770|O1|Outcome|ClNa 0.3%|maintenance solution with ClNa 0.3%
238911|NCT01251770|O2|Outcome|ClNa 0.45%|maintenance solution with ClNa 0.45%
238912|NCT01251770|O1|Outcome|ClNa 0.3%|maintenance solution with ClNa 0.3%
238913|NCT01251770|E2|Reported Event|ClNa 0.45%|maintenance solution with ClNa 0.45%
238914|NCT01251770|E1|Reported Event|ClNa 0.3%|maintenance solution with ClNa 0.3%
238915|NCT01251757|B4|Baseline|Total|Total of all reporting groups
238953|NCT01251653|B6|Baseline|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
238954|NCT01251653|B5|Baseline|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239573|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
238916|NCT01251757|B3|Baseline|Enhanced IVR (IVR+)|"Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.
The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."
238917|NCT01251757|B2|Baseline|Interactive Voice Recognition (IVR)|"In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.
The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population."
238918|NCT01251757|B1|Baseline|Usual Care (UC)|Participants in this arm had full access to all care they were normally entitled to as part of usual care
238919|NCT01251757|P3|Participant Flow|Enhanced IVR (IVR+)|"Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.
The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."
238920|NCT01251757|P2|Participant Flow|Interactive Voice Recognition (IVR)|"In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.
The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population."
238921|NCT01251757|P1|Participant Flow|Usual Care (UC)|Participants in this arm had full access to all care they were normally entitled to as part of usual care
238922|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
238923|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
238924|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
238925|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
238926|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
238927|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
238928|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
238929|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm .
238930|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
238931|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
238932|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm .
238933|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
238934|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
238935|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm
238946|NCT01251757|E3|Reported Event|Enhanced IVR (IVR+)|usual care plus automated phone calls plus educational mailings and mail follow-up for persistent nonadherence
238947|NCT01251757|E2|Reported Event|Interactive Voice Recognition (IVR)|usual care plus automated phone calls
238948|NCT01251757|E1|Reported Event|Usual Care (UC)|usual medical care
238949|NCT01251653|B10|Baseline|Total|Total of all reporting groups
238950|NCT01251653|B9|Baseline|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238951|NCT01251653|B8|Baseline|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238952|NCT01251653|B7|Baseline|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239448|NCT01250769|P3|Participant Flow|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
238955|NCT01251653|B4|Baseline|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238956|NCT01251653|B3|Baseline|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238957|NCT01251653|B2|Baseline|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238958|NCT01251653|B1|Baseline|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238959|NCT01251653|P9|Participant Flow|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238960|NCT01251653|P8|Participant Flow|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238961|NCT01251653|P7|Participant Flow|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238962|NCT01251653|P6|Participant Flow|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
238963|NCT01251653|P5|Participant Flow|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238964|NCT01251653|P4|Participant Flow|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238965|NCT01251653|P3|Participant Flow|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238966|NCT01251653|P2|Participant Flow|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238967|NCT01251653|P1|Participant Flow|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238968|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238969|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238970|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238971|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238972|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238973|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238974|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238975|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238976|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238977|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239925|NCT01249651|P1|Participant Flow|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
238978|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238979|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238980|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238981|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238982|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238983|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238984|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
281518|NCT00102804|B3|Baseline|Total|Total of all reporting groups
238985|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238986|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238987|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238988|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238989|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238990|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238991|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238992|NCT01251653|O6|Outcome|Afatinib 30mg Without Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
238993|NCT01251653|O5|Outcome|Afatinib 30mg With Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238994|NCT01251653|O4|Outcome|Afatinib 30mg Without Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
238995|NCT01251653|O3|Outcome|Afatinib 30mg With Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
238996|NCT01251653|O2|Outcome|Afatinib 40mg Without Gemcitabine|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in 3- week treatment course.
238997|NCT01251653|O1|Outcome|Afatinib 40mg With Gemcitabine 1000 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
238998|NCT01251653|O6|Outcome|Afatinib 30mg Without Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
238999|NCT01251653|O5|Outcome|Afatinib 30mg With Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239000|NCT01251653|O4|Outcome|Afatinib 30mg Without Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
239001|NCT01251653|O3|Outcome|Afatinib 30mg With Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
239002|NCT01251653|O2|Outcome|Afatinib 40mg Without Gemcitabine|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in 3- week treatment course.
239003|NCT01251653|O1|Outcome|Afatinib 40mg With Gemcitabine 1000 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239004|NCT01251653|O3|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239005|NCT01251653|O2|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
239006|NCT01251653|O1|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239007|NCT01251653|O3|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239008|NCT01251653|O2|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
294903|NCT00138671|O1|Outcome|Inhaled Insulin|
239009|NCT01251653|O1|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239010|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239011|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239012|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239013|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
239014|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239015|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239016|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239017|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239018|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239019|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239020|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239021|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239022|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
239023|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239024|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239025|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239026|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239027|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239028|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239029|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239030|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239031|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
239032|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239033|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239034|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239035|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239036|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239037|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239038|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239039|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239040|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
239041|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239042|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239043|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239044|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239045|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239046|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239047|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239048|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239049|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
239050|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239051|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239052|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239053|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239054|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239055|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239056|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239057|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239058|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
239059|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239060|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239061|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239062|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239063|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239064|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239065|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239066|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239067|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
239068|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239069|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239070|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239071|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239072|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239073|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239074|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239075|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239076|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
239077|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239078|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239079|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239080|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239081|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239082|NCT01251653|E9|Reported Event|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239083|NCT01251653|E8|Reported Event|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239084|NCT01251653|E7|Reported Event|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239085|NCT01251653|E6|Reported Event|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
239086|NCT01251653|E5|Reported Event|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239087|NCT01251653|E4|Reported Event|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239088|NCT01251653|E3|Reported Event|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239203|NCT01251380|B1|Baseline|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239089|NCT01251653|E2|Reported Event|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239090|NCT01251653|E1|Reported Event|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
239091|NCT01251614|B4|Baseline|Total|Total of all reporting groups
239092|NCT01251614|B3|Baseline|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239210|NCT01251380|O1|Outcome|Dysport Treatment Cycle 1|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239093|NCT01251614|B2|Baseline|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239094|NCT01251614|B1|Baseline|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239095|NCT01251614|P3|Participant Flow|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239096|NCT01251614|P2|Participant Flow|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239097|NCT01251614|P1|Participant Flow|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239145|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
239146|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239098|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239099|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239153|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239161|NCT01251614|E7|Reported Event|Period C: Adalimumab 0.4 mg/kg|Participants initially randomized to adalimumab 0.4 mg/kg with loss of disease control in Period B received adalimumab 0.4 mg/kg eow for up to 16 weeks in Period C.
239100|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239101|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239102|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239103|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239104|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239105|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239106|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
239107|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239108|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239154|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
239162|NCT01251614|E6|Reported Event|Period B: ADA 0.8 mg/kg/No Treatment|Participants initially randomized to adalimumab (ADA) 0.8 mg/kg who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
239109|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239110|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239111|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239112|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239113|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239114|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239115|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239155|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239163|NCT01251614|E5|Reported Event|Period B: ADA 0.4 mg/kg/No Treatment|Participants initially randomized to adalimumab (ADA) 0.4 mg/kg who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
239116|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239117|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239118|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239119|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239120|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239121|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239122|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239156|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239164|NCT01251614|E4|Reported Event|Period B: MTX/No Treatment|Participants initially randomized to methotrexate who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
282697|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
239123|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239124|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239125|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239126|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239127|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239128|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239129|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239157|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
239158|NCT01251614|E10|Reported Event|Period D: Adalimumab 0.8 mg/kg|Participants received adalimumab 0.8 mg/kg eow for up to 52 weeks in Period D.
239256|NCT01251315|O6|Outcome|Proimmune 200-B|Proimmune 200 High dose group (6000mg oral x1)
239130|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239131|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239132|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239133|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239134|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239135|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239136|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239159|NCT01251614|E9|Reported Event|Period D: Adalimumab 0.4 mg/kg|Participants received adalimumab 0.4 mg/kg eow for up to 52 weeks in Period D.
239160|NCT01251614|E8|Reported Event|Period C: Adalimumab 0.8 mg/kg|Participants initially randomized to either methotrexate or adalimumab 0.8 mg/kg with loss of disease control in Period B received adalimumab 0.8 mg/kg eow for up to 16 weeks in Period C.
239257|NCT01251315|O5|Outcome|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group (1200 mg oral x1)
239258|NCT01251315|O4|Outcome|Placebo-B|Placebo High dose group
239137|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239138|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
239139|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
239140|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239141|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239142|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
239143|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239144|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239200|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239201|NCT01251588|E2|Reported Event|Microfracture|Microfracture: Arthroscopic Microfracture
239147|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239148|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
239149|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239150|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239151|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
239152|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239259|NCT01251315|O3|Outcome|Proimmune 200-A|Proimmune 200 low dose group ( 3000mg oral x1)
283241|NCT00105469|E2|Reported Event|Tobramycin|
239165|NCT01251614|E3|Reported Event|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239166|NCT01251614|E2|Reported Event|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
239167|NCT01251614|E1|Reported Event|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
239168|NCT01251588|B3|Baseline|Total|Total of all reporting groups
239169|NCT01251588|B2|Baseline|Microfracture|Microfracture: Arthroscopic Microfracture
239170|NCT01251588|B1|Baseline|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239171|NCT01251588|P2|Participant Flow|Microfracture|Microfracture: Arthroscopic Microfracture
239172|NCT01251588|P1|Participant Flow|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239173|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239174|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239175|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239176|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239177|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239178|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239179|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239180|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239181|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239182|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239183|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239184|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239185|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239186|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239187|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239188|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239189|NCT01251588|O2|Outcome|Microfracture|"Microfracture treatment received in previous MACI00206 study
Microfracture: Arthroscopic Microfracture treatment received in the previous MACI00206 study"
239190|NCT01251588|O1|Outcome|MACI|"autologous cultured chondrocytes on porcine collagen membrane implant received in previous MACI00206 study
autologous cultured chondrocytes on porcine collagen membrane: Implantation received in the previous MACI00206 study"
239191|NCT01251588|O2|Outcome|Microfracture|"Microfracture treatment received in previous MACI00206 study
Microfracture: Arthroscopic Microfracture treatment received in the previous MACI00206 study"
239192|NCT01251588|O1|Outcome|MACI|"autologous cultured chondrocytes on porcine collagen membrane implant received in previous MACI00206 study
autologous cultured chondrocytes on porcine collagen membrane: Implantation received in the previous MACI00206 study"
239193|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239194|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239195|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239196|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239197|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239198|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
239199|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
239204|NCT01251380|P1|Participant Flow|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239205|NCT01251380|O3|Outcome|Dysport Treatment Cycle 3|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239206|NCT01251380|O2|Outcome|Dysport Treatment Cycle 2|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239207|NCT01251380|O1|Outcome|Dysport Treatment Cycle 1|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239208|NCT01251380|O3|Outcome|Dysport Treatment Cycle 3|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239209|NCT01251380|O2|Outcome|Dysport Treatment Cycle 2|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239260|NCT01251315|O2|Outcome|N Acetyl Cysteine-A|N Acetyl cysteine low dose group ( 600mg oral x1)
239211|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239212|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239213|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239214|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239215|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239216|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239217|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239218|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5U/kg to 20U/kg for one leg and 10U/kg to 30U/kg for both legs
239219|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239220|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239221|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239222|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239223|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239224|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
239225|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs.
239226|NCT01251380|E1|Reported Event|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs.
239227|NCT01251354|B1|Baseline|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
239228|NCT01251354|P1|Participant Flow|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
239229|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
239230|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
239231|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
239232|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
239233|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
239234|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
239235|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
239236|NCT01251354|E1|Reported Event|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
239237|NCT01251315|B7|Baseline|Total|Total of all reporting groups
239238|NCT01251315|B6|Baseline|Proimmune 200-B|Proimmune 200 High dose group (6000mg oral x1)
239239|NCT01251315|B5|Baseline|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group ( 1200mg oral X1)
239240|NCT01251315|B4|Baseline|Placebo-B|High dose oral X1
239241|NCT01251315|B3|Baseline|Proimmune 200-A|Proimmune 200 low dose group (3000mg oral X 1)
239242|NCT01251315|B2|Baseline|N Acetyl Cysteine-A|N Acetyl cysteine low dose group (600mg oral X1)
239243|NCT01251315|B1|Baseline|Placebo-A|low dose oral x1
239244|NCT01251315|P6|Participant Flow|Proimmune 200 (High Dose, 6000 mg Oral as a Single Dose)|Proimmune 200 (high dose, 6000 mg oral as a single dose)
239245|NCT01251315|P5|Participant Flow|N Acetyl Cysteine (High Dose, 1200 mg Oral as a Single Dose)|N Acetyl cysteine (high dose 1200 mg oral as a single dose)
239246|NCT01251315|P4|Participant Flow|Placebo High Dose Group, Given Oral as a Single Dose|Placebo high dose group, given oral as a single dose
239247|NCT01251315|P3|Participant Flow|Proimmune 200 (Low Dose, 3000 mg Oral as a Single Dose)|Proimmune 200 (low dose, 3000 mg oral as a single dose)
239248|NCT01251315|P2|Participant Flow|N Acetyl Cysteine (Low Dose, 600mg Oral as a Single Dose)|N Acetyl cysteine (low dose, 600mg oral as a single dose)
239249|NCT01251315|P1|Participant Flow|Placebo Low Dose Group, Given Oral as a Single Dose|Placebo low dose group, given oral as a single dose
239250|NCT01251315|O6|Outcome|Proimmune 200-B|Proimmune 200 High dose group
239251|NCT01251315|O5|Outcome|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group
239252|NCT01251315|O4|Outcome|Placebo-B|Placebo High dose group
239253|NCT01251315|O3|Outcome|Proimmune 200-A|Proimmune 200 low dose group
239254|NCT01251315|O2|Outcome|N Acetyl Cysteine-A|N Acetyl cysteine low dose group
239255|NCT01251315|O1|Outcome|Placebo-A|Placebo low dose group
239269|NCT01251276|B2|Baseline|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239270|NCT01251276|B1|Baseline|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239271|NCT01251276|P2|Participant Flow|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239272|NCT01251276|P1|Participant Flow|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239273|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239274|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239275|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239276|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239277|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239278|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239279|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239280|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239281|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239282|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239283|NCT01251276|O2|Outcome|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239284|NCT01251276|O1|Outcome|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239285|NCT01251276|E2|Reported Event|ENGERIX-B™ Vaccine in Base Study|Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239286|NCT01251276|E1|Reported Event|Modified Process Hepatitis B Vaccine in Base Study|Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
239287|NCT01251146|B3|Baseline|Total|Total of all reporting groups
239288|NCT01251146|B2|Baseline|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239289|NCT01251146|B1|Baseline|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239326|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239327|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239449|NCT01250769|P2|Participant Flow|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
283242|NCT00105469|E1|Reported Event|AzaSite|
239290|NCT01251146|P2|Participant Flow|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239291|NCT01251146|P1|Participant Flow|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239292|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239293|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239294|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239295|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239296|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239297|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239328|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239329|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239450|NCT01250769|P1|Participant Flow|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
241734|NCT01243450|O2|Outcome|Placebo|"placebo cream
Tretinoin: Topical skin
placebo"
239298|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239299|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239300|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239301|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239302|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239303|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239304|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239305|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239330|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239331|NCT01251120|E2|Reported Event|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239451|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
239306|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239307|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239308|NCT01251146|E2|Reported Event|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239309|NCT01251146|E1|Reported Event|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
239310|NCT01251120|B3|Baseline|Total|Total of all reporting groups
239311|NCT01251120|B2|Baseline|Placebo|Participants received Non-biologic DMARDs (including methotrexate) according to current best practice
239312|NCT01251120|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate)
239313|NCT01251120|P2|Participant Flow|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239314|NCT01251120|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously every 4 weeks along with background disease-modifying antirheumatic drugs (DMARDs) including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239315|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239316|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239317|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239318|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239319|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239405|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239320|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239321|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239322|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239323|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239324|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239325|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239416|NCT01250925|E2|Reported Event|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239332|NCT01251120|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
239333|NCT01251042|B3|Baseline|Total|Total of all reporting groups
239334|NCT01251042|B2|Baseline|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239335|NCT01251042|B1|Baseline|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239336|NCT01251042|P2|Participant Flow|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239337|NCT01251042|P1|Participant Flow|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239338|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239339|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239340|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239341|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239342|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239343|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239344|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239345|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239346|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239347|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239348|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239349|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239350|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239351|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239352|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239353|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239354|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239355|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239356|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239357|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239358|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239359|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239360|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239361|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239362|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239363|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239364|NCT01251042|E2|Reported Event|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
239365|NCT01251042|E1|Reported Event|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
239366|NCT01250990|B3|Baseline|Total|Total of all reporting groups
239367|NCT01250990|B2|Baseline|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.
Placebo: Placebo"
239368|NCT01250990|B1|Baseline|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.
Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
239369|NCT01250990|P2|Participant Flow|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.
Placebo: Placebo"
239926|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
239370|NCT01250990|P1|Participant Flow|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.
Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
239371|NCT01250990|O2|Outcome|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.
Placebo: Placebo"
239372|NCT01250990|O1|Outcome|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.
Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
239373|NCT01250990|E2|Reported Event|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.
Placebo: Placebo"
239417|NCT01250925|E1|Reported Event|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239418|NCT01250899|B3|Baseline|Total|Total of all reporting groups
239574|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239374|NCT01250990|E1|Reported Event|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.
Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
239375|NCT01250925|B4|Baseline|Total|Total of all reporting groups
239376|NCT01250925|B3|Baseline|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239377|NCT01250925|B2|Baseline|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239378|NCT01250925|B1|Baseline|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239379|NCT01250925|P3|Participant Flow|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239380|NCT01250925|P2|Participant Flow|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239381|NCT01250925|P1|Participant Flow|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239382|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239383|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239384|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239385|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239386|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239387|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239388|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239389|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239390|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239391|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239392|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239393|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239394|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239395|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239396|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239397|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239398|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239399|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239400|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239401|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239402|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239403|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239404|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239555|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239406|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239407|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239408|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239409|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239410|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239411|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239412|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239413|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239414|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
239415|NCT01250925|E3|Reported Event|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
241735|NCT01243450|O1|Outcome|Active Generic|"active cream
Tretinoin: Topical skin"
239419|NCT01250899|B2|Baseline|Vitamin D Insufficient|HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks.
239420|NCT01250899|B1|Baseline|Vitamin D Sufficient|HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
239421|NCT01250899|P2|Participant Flow|Vitamin D Insufficient|HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
239422|NCT01250899|P1|Participant Flow|Vitamin D Sufficient|HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
239423|NCT01250899|O1|Outcome|Vitamin D Insufficient|Baseline 25(OH)D <30 ng/mL received 12 weeks of oral vitamin D supplementation. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
239424|NCT01250899|E1|Reported Event|Vitamin D Insufficient|25(OH)D <30 mg/mL at study entry (i.e. group of patients receiving vitamin D supplementation).
239425|NCT01250834|B1|Baseline|LY2189265 + Atorvastatin|"Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3."
239426|NCT01250834|P1|Participant Flow|LY2189265 + Atorvastatin|"Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3."
239427|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
239428|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
239429|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
239430|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
239431|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
239432|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
239433|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
239434|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
239435|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
239436|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
239437|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
239438|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
239927|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
239439|NCT01250834|E3|Reported Event|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was after the atorvastatin dose on Day 3 in Period 2.
239440|NCT01250834|E2|Reported Event|1.5 mg LY2189265|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was from Day 1 to predose of atorvastatin on Day 3.
239441|NCT01250834|E1|Reported Event|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
239442|NCT01250769|B5|Baseline|Total|Total of all reporting groups
239443|NCT01250769|B4|Baseline|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
239444|NCT01250769|B3|Baseline|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
239445|NCT01250769|B2|Baseline|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
239446|NCT01250769|B1|Baseline|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
239447|NCT01250769|P4|Participant Flow|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
239575|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239452|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
239453|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
239454|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
239455|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
239456|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
239457|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
239458|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
239459|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
239460|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
239461|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
239462|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
239463|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
239464|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
239465|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
239466|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
239467|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
239468|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
239469|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
239470|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
239471|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
239472|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
239473|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
239474|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
239475|NCT01250769|E4|Reported Event|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
239476|NCT01250769|E3|Reported Event|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
239477|NCT01250769|E2|Reported Event|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
239478|NCT01250769|E1|Reported Event|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
239479|NCT01250756|B3|Baseline|Total|Total of all reporting groups
239480|NCT01250756|B2|Baseline|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239481|NCT01250756|B1|Baseline|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239556|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239557|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239482|NCT01250756|P2|Participant Flow|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239483|NCT01250756|P1|Participant Flow|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239484|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239485|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239486|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239487|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239488|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239489|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239490|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239491|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239492|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239493|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239494|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239558|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239559|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
298152|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
239495|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239496|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239497|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239498|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239526|NCT01250756|E6|Reported Event|DTaP (Catch-up 7vPnC) - Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
241736|NCT01243450|E3|Reported Event|Brand|Tretinoin: Topical skin
239499|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239500|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239501|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239502|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239503|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239504|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239505|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239506|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239507|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239508|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239509|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239510|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239511|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239527|NCT01250756|E5|Reported Event|7vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
239576|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239512|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239513|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239514|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239515|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239516|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239517|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239518|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239519|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239520|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
298153|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
239521|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239522|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239523|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
239524|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
239525|NCT01250756|E7|Reported Event|DTaP (Catch-up 7vPnC) - After the Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
239572|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239528|NCT01250756|E4|Reported Event|DTaP (Catch-up 7vPnC) - After the Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
239529|NCT01250756|E3|Reported Event|7vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
239530|NCT01250756|E2|Reported Event|DTaP (Catch-up 7vPnC)- Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
239531|NCT01250756|E1|Reported Event|7vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
239532|NCT01250730|B4|Baseline|Total|Total of all reporting groups
239533|NCT01250730|B3|Baseline|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239534|NCT01250730|B2|Baseline|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239535|NCT01250730|B1|Baseline|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239536|NCT01250730|P3|Participant Flow|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239537|NCT01250730|P2|Participant Flow|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239538|NCT01250730|P1|Participant Flow|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239539|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239540|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239541|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239542|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239543|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239544|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239545|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239546|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239547|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239548|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239549|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239550|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239551|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239552|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239553|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239554|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239560|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239561|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239562|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239563|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239564|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239565|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239566|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239567|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239568|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239569|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239570|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239571|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239577|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239578|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239579|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239580|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239581|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239582|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239583|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239584|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239585|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239586|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239587|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239588|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239589|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239590|NCT01250730|E3|Reported Event|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
239591|NCT01250730|E2|Reported Event|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
239592|NCT01250730|E1|Reported Event|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
239593|NCT01250717|B1|Baseline|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.
Docetaxel Followed by Radical Prostatectomy
Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy
Zoladex : Given subcutaneously for 4 doses every three months
Casodex : Taken orally once a day for 6 months
Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle
Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle
Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
239594|NCT01250717|P1|Participant Flow|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.
Docetaxel Followed by Radical Prostatectomy
Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy
Zoladex : Given subcutaneously for 4 doses every three months
Casodex : Taken orally once a day for 6 months
Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle
Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle
Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
239595|NCT01250717|O1|Outcome|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.
Docetaxel Followed by Radical Prostatectomy
Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy
Zoladex : Given subcutaneously for 4 doses every three months
Casodex : Taken orally once a day for 6 months
Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle
Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle
Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
239596|NCT01250717|E1|Reported Event|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.
Docetaxel Followed by Radical Prostatectomy
Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy
Zoladex : Given subcutaneously for 4 doses every three months
Casodex : Taken orally once a day for 6 months
Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle
Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle
Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
239597|NCT01250509|B3|Baseline|Total|Total of all reporting groups
239598|NCT01250509|B2|Baseline|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
298154|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
239599|NCT01250509|B1|Baseline|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
239600|NCT01250509|P2|Participant Flow|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
239601|NCT01250509|P1|Participant Flow|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
239602|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
239603|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
239604|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
239605|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
239606|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
239607|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
239608|NCT01250509|O2|Outcome|Waitlist|
239609|NCT01250509|O1|Outcome|CALMM|
239610|NCT01250509|E2|Reported Event|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
239611|NCT01250509|E1|Reported Event|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
239614|NCT01250418|B1|Baseline|Ketamine Group|"ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min."
239615|NCT01250418|P2|Participant Flow|No Ketamine|No ketamine added to anesthesia regimen
239616|NCT01250418|P1|Participant Flow|Ketamine Group|ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
239617|NCT01250418|O2|Outcome|No Ketamine|No ketamine added to anesthesia regimen
239618|NCT01250418|O1|Outcome|Ketamine Group|"ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min."
239619|NCT01250418|E2|Reported Event|Ketamine Group|Ketamine group: Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
239620|NCT01250418|E1|Reported Event|No Ketamine Added to Anesthesia Regimen|No ketamine added to the patients anesthesia regimen
239621|NCT01250379|B3|Baseline|Total|Total of all reporting groups
239622|NCT01250379|B2|Baseline|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239623|NCT01250379|B1|Baseline|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239624|NCT01250379|P2|Participant Flow|Chemotherapy Plus Bevacizumab (CT+BV) Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 milligrams per kilogram (mg/kg), intravenously (IV), every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239625|NCT01250379|P1|Participant Flow|Chemotherapy (CT) Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239633|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239626|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239627|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239691|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
239692|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)"
239693|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
239961|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
239628|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239629|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239630|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239631|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239632|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239682|NCT01250184|B4|Baseline|Total|Total of all reporting groups
239683|NCT01250184|B3|Baseline|Blocking the MTP|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
239634|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239635|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239694|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
239636|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239637|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239638|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239639|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239640|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239641|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239642|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239643|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239695|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)"
239696|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
283243|NCT00105482|B3|Baseline|Total|Total of all reporting groups
239644|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239645|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239646|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239647|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239648|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239649|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239650|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239651|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239697|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
239652|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239653|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239654|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239655|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239656|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239657|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239658|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239659|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239698|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)"
239699|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
285218|NCT00110305|E2|Reported Event|Efavirenz|Efavirenz 600 mg once daily
239660|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239661|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239662|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239663|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239664|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239665|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239666|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239667|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239700|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
239668|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239669|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239670|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239671|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239672|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239673|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239674|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239675|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239701|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)"
239702|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
286004|NCT00114517|B4|Baseline|Late Postmenopause Placebo|
239676|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239677|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239678|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239679|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239680|NCT01250379|E2|Reported Event|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239681|NCT01250379|E1|Reported Event|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
239684|NCT01250184|B2|Baseline|Physical Therapy|"Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)"
239685|NCT01250184|B1|Baseline|Blocking the MTP Plus Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
239686|NCT01250184|P3|Participant Flow|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
239687|NCT01250184|P2|Participant Flow|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
239688|NCT01250184|P1|Participant Flow|Physical Therapy|"Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)"
239689|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)"
239690|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
239962|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239703|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
239704|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)"
239705|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
239706|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
239707|NCT01250184|E3|Reported Event|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
239708|NCT01250184|E2|Reported Event|Physical Therapy|"Twelve sessions, 3 per week.
Physical therapy: Twelve sessions (3 per week)"
239709|NCT01250184|E1|Reported Event|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
239710|NCT01250171|B4|Baseline|Total|Total of all reporting groups
239711|NCT01250171|B3|Baseline|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
239712|NCT01250171|B2|Baseline|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
239713|NCT01250171|B1|Baseline|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
239714|NCT01250171|P3|Participant Flow|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
239715|NCT01250171|P2|Participant Flow|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
239716|NCT01250171|P1|Participant Flow|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
239717|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
239718|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
239719|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
239720|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
239721|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
239722|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
239723|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
239724|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
239725|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
239726|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
239727|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
239728|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
239729|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
239730|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
239731|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
239732|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
298155|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
239733|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
239734|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
239735|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
239736|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
239737|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
239738|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
239739|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
239740|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
239741|NCT01250171|E3|Reported Event|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
239742|NCT01250171|E2|Reported Event|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
239743|NCT01250171|E1|Reported Event|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
239744|NCT01250145|B3|Baseline|Total|Total of all reporting groups
239963|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
239745|NCT01250145|B2|Baseline|LY333334 + Placebo: Part B|"Part B:
Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks
Rest phase: 2 weeks with no patch application
Challenge phase: 80 microgram active patch given once for at least 6 hours"
239746|NCT01250145|B1|Baseline|LY333334 + Placebo: Part A|"Part A:
Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
239747|NCT01250145|P2|Participant Flow|LY333334 + Placebo: Part B|"Part B:
Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks
Rest phase: 2 weeks with no patch application
Challenge phase: 80 microgram active patch given once for at least 6 hours"
239748|NCT01250145|P1|Participant Flow|LY333334 + Placebo: Part A|"Part A:
Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
239749|NCT01250145|O2|Outcome|Placebo Patch|"Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.
Rest phase: 2 weeks with no patch application
Challenge phase: placebo patch given once for at least 6 hours"
239750|NCT01250145|O1|Outcome|Active Patch|"Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.
Rest phase: 2 weeks with no patch application
Challenge phase: 80 microgram active patch given once for at least 6 hours"
239751|NCT01250145|O6|Outcome|Part B: Placebo Patch - 24 Hours Post Patch Application|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
239752|NCT01250145|O5|Outcome|Part B: Placebo Patch - 1 Hour Post Patch Removal|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
239753|NCT01250145|O4|Outcome|Part B: Placebo Patch - Prior to Patch Application|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
239754|NCT01250145|O3|Outcome|Part B: Active Patch - 24 Hours Post Patch Application|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
239755|NCT01250145|O2|Outcome|Part B: Active Patch - 1 Hour Post Patch Removal|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
239756|NCT01250145|O1|Outcome|Part B: Active Patch - Prior to Patch Application|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
239757|NCT01250145|O2|Outcome|Placebo Patch|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
239758|NCT01250145|O1|Outcome|Active Patch|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
239759|NCT01250145|O6|Outcome|Part A: Placebo Patch - 24 Hours Post Patch Application|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
239760|NCT01250145|O5|Outcome|Part A: Placebo Patch - 1 Hour Post Patch Removal|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
239761|NCT01250145|O4|Outcome|Part A: Placebo Patch - Prior to Patch Application|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
239762|NCT01250145|O3|Outcome|Part A: Active Patch - 24 Hours Post Patch Application|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
239763|NCT01250145|O2|Outcome|Part A: Active Patch - 1 Hour Post Patch Removal|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
239796|NCT01250002|O1|Outcome|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
298156|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
239764|NCT01250145|O1|Outcome|Part A: Active Patch - Prior to Patch Application|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
239765|NCT01250145|E2|Reported Event|LY333334 + Placebo: Part B|"Part B:
Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks
Rest phase: 2 weeks with no patch application
Challenge phase: 80 microgram active patch given once for at least 6 hours"
239766|NCT01250145|E1|Reported Event|LY333334 + Placebo: Part A|"Part A:
Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
239767|NCT01250119|B1|Baseline|NSCLC Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.
239768|NCT01250119|P2|Participant Flow|Erlotinib 150 Milligrams Per Day (mg/Day)|During the Treatment Phase participants found to have a tumour with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until progressive disease (PD), death, unacceptable toxicity or withdrawal of consent.
239769|NCT01250119|P1|Participant Flow|Non-small-cell Lung Cancer (NSCLC) Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
239770|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
239945|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239771|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
239772|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
239773|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
239774|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
239775|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
239776|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
239777|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
239778|NCT01250119|O2|Outcome|EGFR Negative|All participants who tested negative for EGFR mutations were included in this group.
239779|NCT01250119|O1|Outcome|EGFR Positive|All participants who tested positive for EGFR mutations were included in this group.
239780|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
239781|NCT01250119|O1|Outcome|NSCLC Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.
239782|NCT01250119|E1|Reported Event|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
239783|NCT01250054|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
239784|NCT01250054|P2|Participant Flow|Comfilcon A /Lotrafilcon B|Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
239785|NCT01250054|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
239786|NCT01250054|O2|Outcome|Comfilcon A|Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
239787|NCT01250054|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
239788|NCT01250054|E2|Reported Event|Comfilcon A|Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
239789|NCT01250054|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
239790|NCT01250002|B3|Baseline|Total|Total of all reporting groups
239791|NCT01250002|B2|Baseline|Placebo|Group B (control group) will receive the same volume of saline infusion.
239792|NCT01250002|B1|Baseline|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
239793|NCT01250002|P2|Participant Flow|Placebo|Group B (control group) will receive the same volume of saline infusion.
239794|NCT01250002|P1|Participant Flow|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
239795|NCT01250002|O2|Outcome|Placebo|Group B (control group) will receive the same volume of saline infusion.
298157|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
239797|NCT01250002|O2|Outcome|Placebo|Group B (control group) will receive the same volume of saline infusion.
239798|NCT01250002|O1|Outcome|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
239799|NCT01250002|E2|Reported Event|Placebo|Group B (control group) will receive the same volume of saline infusion.
239800|NCT01250002|E1|Reported Event|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
239801|NCT01249872|B7|Baseline|Total|Total of all reporting groups
239802|NCT01249872|B6|Baseline|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive an epidural bolus dose of 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239803|NCT01249872|B5|Baseline|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239804|NCT01249872|B4|Baseline|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 2 ml of normal saline. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239946|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239805|NCT01249872|B3|Baseline|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intraoperatively (45 min before the estimated end of the surgery) an epidural bolus dose 2 mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239806|NCT01249872|B2|Baseline|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intraoperatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239807|NCT01249872|B1|Baseline|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239808|NCT01249872|P6|Participant Flow|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239809|NCT01249872|P5|Participant Flow|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239810|NCT01249872|P4|Participant Flow|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239811|NCT01249872|P3|Participant Flow|GROUP C : 2 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239812|NCT01249872|P2|Participant Flow|GROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239813|NCT01249872|P1|Participant Flow|GROUP A : 0 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239814|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239815|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239922|NCT01249664|E2|Reported Event|Sham Treatment (Until Week 20)|Participants received a sham injection every 4 weeks from week 0 through week 20. Participants were observed until week 24. Participants in the safety population were at risk.
239928|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
239816|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239817|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239818|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239819|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239820|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239947|NCT01249417|E3|Reported Event|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239964|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239821|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239822|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239823|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239824|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239825|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239826|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239827|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239828|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239829|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239830|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239831|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239832|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239833|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239834|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239835|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239836|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239948|NCT01249417|E2|Reported Event|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239949|NCT01249417|E1|Reported Event|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239837|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239838|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239839|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239840|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239841|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239842|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239843|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239844|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239845|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239846|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239847|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239848|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239849|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239850|NCT01249872|E6|Reported Event|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239851|NCT01249872|E5|Reported Event|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239852|NCT01249872|E4|Reported Event|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239950|NCT01249274|B3|Baseline|Total|Total of all reporting groups
239951|NCT01249274|B2|Baseline|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
241737|NCT01243450|E2|Reported Event|Placebo|"placebo cream
Tretinoin: Topical skin
placebo"
239853|NCT01249872|E3|Reported Event|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239854|NCT01249872|E2|Reported Event|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239855|NCT01249872|E1|Reported Event|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
239856|NCT01249833|B3|Baseline|Total|Total of all reporting groups
239857|NCT01249833|B2|Baseline|Standard of Care Alone|Standard of care for influenza
239858|NCT01249833|B1|Baseline|Oseltamivir|"Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days"
239859|NCT01249833|P2|Participant Flow|Standard of Care Alone|Standard of care for influenza
239860|NCT01249833|P1|Participant Flow|Oseltamivir|"Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days"
239861|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
239862|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days"
239863|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
239864|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days"
239865|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
239866|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days"
239867|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
239868|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days"
239869|NCT01249833|E2|Reported Event|Standard of Care Alone|Standard of care for influenza
239870|NCT01249833|E1|Reported Event|Oseltamivir|"Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days"
239871|NCT01249664|B3|Baseline|Total|Total of all reporting groups
239872|NCT01249664|B2|Baseline|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239873|NCT01249664|B1|Baseline|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239929|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
239930|NCT01249651|E1|Reported Event|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
239931|NCT01249417|B4|Baseline|Total|Total of all reporting groups
239932|NCT01249417|B3|Baseline|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239874|NCT01249664|P2|Participant Flow|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239875|NCT01249664|P1|Participant Flow|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239876|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239877|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239878|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
241738|NCT01243450|E1|Reported Event|Active Generic|"active cream
Tretinoin: Topical skin"
239879|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239880|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239881|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239882|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239883|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239884|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239885|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239933|NCT01249417|B2|Baseline|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239934|NCT01249417|B1|Baseline|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
241405|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
239886|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239887|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239888|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239889|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239890|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239891|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239892|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239893|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239894|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239895|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239896|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239897|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239923|NCT01249664|E1|Reported Event|Aflibercept Injection (Until Week 20)|Participants received a 2 mg single dose of IAI at baseline (Week 20). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 20 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed until week 24. Participants in the safety population were at risk.
239898|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239899|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239900|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239901|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239902|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239903|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239952|NCT01249274|B1|Baseline|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239953|NCT01249274|P2|Participant Flow|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
239954|NCT01249274|P1|Participant Flow|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239955|NCT01249274|O2|Outcome|Progesterone|Progesterone: 100mgs progesterone twice daily
239904|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239905|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239906|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239907|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239908|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239909|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239910|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239911|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239912|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239913|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239914|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239915|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239956|NCT01249274|O1|Outcome|Placebo|Placebo: Matched placebo pills to be taken twice daily
239957|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
239958|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239959|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
239916|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239917|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239918|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239919|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
239920|NCT01249664|E4|Reported Event|Sham Treatment Then Aflibercept Injection (Until Week 44)|Participants who continued the sham treatment until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment were not met, participant received a sham injection. Participants were observed from Week 24 until Week 48. Participants in the safety population were at risk.
239921|NCT01249664|E3|Reported Event|Aflibercept Injection (Until Week 44)|Participants who continued the study drug until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed from week 24 until week 48. Participants in the safety population were at risk.
239924|NCT01249651|B1|Baseline|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
239935|NCT01249417|P3|Participant Flow|Placebo|"Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.
Placebo: I.M. injection on day 1 of a single treatment cycle."
239936|NCT01249417|P2|Participant Flow|Dysport 15 U/Kg|"15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle."
239937|NCT01249417|P1|Participant Flow|Dysport 10 U/Kg|"10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle."
239938|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239939|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239940|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239941|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239942|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239943|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239944|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
239960|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239965|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
239966|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239967|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
239968|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239969|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
239970|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239971|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
239972|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239973|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
239974|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239975|NCT01249274|E2|Reported Event|Progesterone|"100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily"
239976|NCT01249274|E1|Reported Event|Placebo|"Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily"
239977|NCT01249261|B3|Baseline|Total|Total of all reporting groups
239978|NCT01249261|B2|Baseline|Risedronate|Risedronate 5mg years 1-7, no drug year 8
239979|NCT01249261|B1|Baseline|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
239980|NCT01249261|P2|Participant Flow|Risedronate|Risedronate 5mg years 1-7, no drug year 8
239981|NCT01249261|P1|Participant Flow|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
239982|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
239983|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
239984|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
239985|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
239986|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
239987|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
239988|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
239989|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
239990|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
239991|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
239992|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
239993|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
239994|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
239995|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
239996|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
239997|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
239998|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
239999|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
240000|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
240001|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
240002|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
240003|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
240004|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
240005|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
240006|NCT01249261|E2|Reported Event|Risedronate|Risedronate 5mg years 1-7, no drug year 8
241406|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
240007|NCT01249261|E1|Reported Event|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
240008|NCT01249157|B1|Baseline|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer.The first 5 patients who consent to the study will be intended for training purposes only.
240009|NCT01249157|P1|Participant Flow|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
240010|NCT01249157|O1|Outcome|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
240011|NCT01249157|E1|Reported Event|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
240012|NCT01249131|B1|Baseline|Entire Study Population|All participants randomized to any treatment.
240013|NCT01249131|P6|Participant Flow|Treatment C First, Then Treatment B, Followed by Treatment A|Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
240014|NCT01249131|P5|Participant Flow|Treatment C First, Then Treatment A, Followed by Treatment B|Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
240015|NCT01249131|P4|Participant Flow|Treatment B First, Then Treatment C, Followed by Treatment A|Treatment B first, then Treatment C, followed by Treatment A Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
240016|NCT01249131|P3|Participant Flow|Treatment B First, Then Treatment A, Followed by Treatment C|Treatment B first, then Treatment A, followed by Treatment C Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in third intervention period.
240017|NCT01249131|P2|Participant Flow|Treatment A First, Then Treatment C, Followed by Treatment B|Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
240018|NCT01249131|P1|Participant Flow|Treatment A First, Then Treatment B, Followed by Treatment C|Treatment A: One 20-milligram (mg) tablet of cobimetinib administered orally with 240 milliliter (mL) room temperature water after at least an 8-hour fast, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard Food and Drug Administration (FDA) high-fat meal, in third intervention period. The washout period between each period was a minimum of 10 days.
240019|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
240020|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240021|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240022|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
240023|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240024|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240025|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
240026|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240027|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240028|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
240029|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240030|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240031|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
240032|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240033|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240034|NCT01249131|E3|Reported Event|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
240035|NCT01249131|E2|Reported Event|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240036|NCT01249131|E1|Reported Event|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
240037|NCT01249118|B1|Baseline|Entire Study Population|"Part 1: Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.
Part 2: Participants received single dose of GDC-0973 2 mg IV infusion and GDC-0973 20 mg oral capsules (four 5-mg capsules) in either of the two intervention periods. There was a washout period of minimum 10 days after each intervention period."
240038|NCT01249118|P3|Participant Flow|Part 2: GDC-0973 Capsules First, Then GDC-0973 IV Infusion|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in first intervention period followed by single dose of GDC-0973 2 mg IV infusion in second intervention period. There was a washout period of minimum 10 days after each intervention period.
240453|NCT01247675|B2|Baseline|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
240039|NCT01249118|P2|Participant Flow|Part 2: GDC-0973 IV Infusion First, Then GDC-0973 Capsules|Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.
240040|NCT01249118|P1|Participant Flow|Part 1: GDC-0973 IV Infusion First, Then GDC-0973 Capsules|Participants received single dose of GDC-0973 2 milligrams (mg) intravenous (IV) infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.
240041|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240042|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240043|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240044|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240045|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240046|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240047|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240048|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240049|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240050|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240051|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240052|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240053|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240054|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240055|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240056|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240057|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240058|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240059|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240060|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240061|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240062|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240272|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
240063|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240064|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240065|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240066|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240067|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240068|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240069|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
240070|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
240071|NCT01249118|E2|Reported Event|GDC-0973 20 mg Oral|Participants received GDC-0973 20 mg oral capsules (four 5-mg capsule) in either intervention period in part 1 and part 2 of the study.
240072|NCT01249118|E1|Reported Event|GDC-0973 2 mg IV|Participants received GDC-0973 2 mg IV infusion in either intervention period in part 1 and part 2 of the study.
240073|NCT01249092|B1|Baseline|Pentoxifylline 400 mg/d|All patients received same intervention.
240074|NCT01249092|P1|Participant Flow|Pentoxifylline 400 mg/d|All patients received same intervention.
240588|NCT01247220|B3|Baseline|Total|Total of all reporting groups
240075|NCT01249092|O1|Outcome|Pentoxifylline 400 mg/d|Descriptive information only of small open label pilot. Small patient number not amenable for any valid statistical comparisons regarding side effects. All patients received same intervention. No SAEs occurred.
240076|NCT01249092|O1|Outcome|Change in Serum TIMP-1 (Tissue Inhibitor metalloproteinase1)|
240077|NCT01249092|O1|Outcome|Change in Alkaline Phosphatase After Pentoxifylline Therapy|
240078|NCT01249092|E1|Reported Event|Pentoxifylline 400 mg/d|All patients received same intervention.
240079|NCT01248949|B6|Baseline|Total|Total of all reporting groups
240080|NCT01248949|B5|Baseline|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240081|NCT01248949|B4|Baseline|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240082|NCT01248949|B3|Baseline|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240083|NCT01248949|B2|Baseline|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240084|NCT01248949|B1|Baseline|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240085|NCT01248949|P5|Participant Flow|MEDI3617 + CARBOPLATIN/ PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240086|NCT01248949|P4|Participant Flow|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240087|NCT01248949|P3|Participant Flow|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240088|NCT01248949|P2|Participant Flow|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240089|NCT01248949|P1|Participant Flow|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240090|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240091|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240092|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240093|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
298158|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
240094|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240095|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240096|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240097|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240098|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240099|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240100|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240328|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240101|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240102|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240103|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240104|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240105|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240106|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240107|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240108|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240109|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240110|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240111|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240112|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240113|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240114|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240115|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240116|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240274|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
298159|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
240117|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240118|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240119|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240120|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240121|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240122|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240123|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240124|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240125|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240126|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240127|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240128|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240129|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240130|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240131|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240132|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240133|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240134|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240135|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240136|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240137|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240138|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240139|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240140|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240141|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240142|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240143|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240144|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240145|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240146|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240147|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240148|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240149|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240150|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240151|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240152|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240153|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240154|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240155|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240156|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240157|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240158|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240159|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240160|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240161|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240162|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240163|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240164|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240165|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240166|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240167|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240168|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240169|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240170|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240171|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240172|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
286005|NCT00114517|B3|Baseline|Late Postmenopause 17B-estradiol|
240173|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240174|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240175|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240176|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240177|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240178|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240179|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240180|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240181|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240182|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240183|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240184|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240185|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240186|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240187|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240273|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
240188|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240189|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240190|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240191|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240192|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240193|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240194|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240195|NCT01248949|E5|Reported Event|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
240196|NCT01248949|E4|Reported Event|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
240197|NCT01248949|E3|Reported Event|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
240198|NCT01248949|E2|Reported Event|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240199|NCT01248949|E1|Reported Event|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
240200|NCT01248936|B1|Baseline|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
240201|NCT01248936|P1|Participant Flow|Overall Trial|Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
240202|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
240203|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
240204|NCT01248936|O1|Outcome|Overall Trial|Participants received Vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, Unmanageable toxicity most probably attributable to Vemurafenib, withdrawal of consent, and Study termination by the Sponsor
240205|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
240206|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
240207|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
240208|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
240209|NCT01248936|E1|Reported Event|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
240210|NCT01248884|B4|Baseline|Total|Total of all reporting groups
240211|NCT01248884|B3|Baseline|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
298160|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
240212|NCT01248884|B2|Baseline|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240213|NCT01248884|B1|Baseline|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240214|NCT01248884|P3|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240215|NCT01248884|P2|Participant Flow|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240216|NCT01248884|P1|Participant Flow|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240217|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexaTM vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexaTM and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240218|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240589|NCT01247220|B2|Baseline|Ranibizumab|"Ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
240219|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240220|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexaTM vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexaTM and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240221|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240222|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240223|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240224|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240225|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240226|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240227|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240228|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240229|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240230|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240231|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240232|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240233|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240234|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240235|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240236|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240237|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
243488|NCT01237327|B2|Baseline|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
240238|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240239|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240240|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240241|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240242|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240243|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240244|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240245|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240246|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240247|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240248|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240249|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240250|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240251|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240252|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240253|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240254|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240255|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240256|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
243489|NCT01237327|B1|Baseline|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
240257|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240258|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240259|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240260|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240261|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240262|NCT01248884|E3|Reported Event|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
240263|NCT01248884|E2|Reported Event|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240264|NCT01248884|E1|Reported Event|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
240265|NCT01248793|B3|Baseline|Total|Total of all reporting groups
240266|NCT01248793|B2|Baseline|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
240267|NCT01248793|B1|Baseline|Group I: Placebo|Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
240268|NCT01248793|P2|Participant Flow|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
240269|NCT01248793|P1|Participant Flow|Group I: Placebo|Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
240270|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
240271|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
241939|NCT01242527|E4|Reported Event|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
240275|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
240276|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
240277|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
240278|NCT01248793|E2|Reported Event|Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
240279|NCT01248793|E1|Reported Event|Placebo -> Golimumab 50 mg|Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escape to receive Golimumab 50 mg SC injection every 4 weeks from Week 16 to Week 20; or Placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48
240280|NCT01248780|B3|Baseline|Total|Total of all reporting groups
240281|NCT01248780|B2|Baseline|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240282|NCT01248780|B1|Baseline|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240283|NCT01248780|P2|Participant Flow|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240329|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240284|NCT01248780|P1|Participant Flow|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240285|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240286|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240287|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240288|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240289|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240290|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240291|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240292|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240293|NCT01248780|E2|Reported Event|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240294|NCT01248780|E1|Reported Event|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escaped to receive golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48; or placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
240295|NCT01248728|B3|Baseline|Total|Total of all reporting groups
240296|NCT01248728|B2|Baseline|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
240297|NCT01248728|B1|Baseline|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
240298|NCT01248728|P2|Participant Flow|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
240299|NCT01248728|P1|Participant Flow|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
240300|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
240301|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
240302|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
240303|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
241569|NCT01244490|E2|Reported Event|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
240304|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
240305|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
240306|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
240307|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
240308|NCT01248728|O2|Outcome|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
240309|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
240310|NCT01248728|E2|Reported Event|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.
If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.
The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
240311|NCT01248728|E1|Reported Event|Omega-3 Fatty Acids|"Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.
Omega-3 Fatty Acids: Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process."
240312|NCT01248468|B4|Baseline|Total|Total of all reporting groups
240313|NCT01248468|B3|Baseline|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240314|NCT01248468|B2|Baseline|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240315|NCT01248468|B1|Baseline|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
240316|NCT01248468|P3|Participant Flow|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240317|NCT01248468|P2|Participant Flow|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240318|NCT01248468|P1|Participant Flow|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
240319|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240320|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240321|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
240322|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240323|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240324|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
240325|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240326|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240327|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
241570|NCT01244490|E1|Reported Event|Placebo|Once daily
240330|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
240331|NCT01248468|E3|Reported Event|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240332|NCT01248468|E2|Reported Event|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
240333|NCT01248468|E1|Reported Event|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
240334|NCT01248455|B1|Baseline|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
240335|NCT01248455|P1|Participant Flow|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
240336|NCT01248455|O1|Outcome|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
240337|NCT01248455|O1|Outcome|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
240338|NCT01248455|E1|Reported Event|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
240339|NCT01248364|B5|Baseline|Total|Total of all reporting groups
240340|NCT01248364|B4|Baseline|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
240341|NCT01248364|B3|Baseline|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240342|NCT01248364|B2|Baseline|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240343|NCT01248364|B1|Baseline|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240344|NCT01248364|P4|Participant Flow|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
240345|NCT01248364|P3|Participant Flow|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240346|NCT01248364|P2|Participant Flow|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240347|NCT01248364|P1|Participant Flow|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240348|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
240349|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240350|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240480|NCT01247571|P1|Participant Flow|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
240351|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240352|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
240353|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240354|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240355|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240356|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
240357|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240358|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240359|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240360|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
241571|NCT01244477|B3|Baseline|Total|Total of all reporting groups
240361|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240362|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240363|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240364|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
240365|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240366|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240367|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240368|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
240369|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240370|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240371|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240372|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
240373|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240374|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240375|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240376|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
240377|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240378|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240379|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240380|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
298161|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
240381|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240382|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240383|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240384|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
240385|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240386|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240387|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240388|NCT01248364|E4|Reported Event|Healthy Subjects|Healthy subjects received empagliflozin (empa) 25mg tablet once daily for 28 days.
240389|NCT01248364|E3|Reported Event|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240390|NCT01248364|E2|Reported Event|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240391|NCT01248364|E1|Reported Event|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
240392|NCT01248221|B3|Baseline|Total|Total of all reporting groups
240393|NCT01248221|B2|Baseline|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240394|NCT01248221|B1|Baseline|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240395|NCT01248221|P2|Participant Flow|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240396|NCT01248221|P1|Participant Flow|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240397|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240398|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240399|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240400|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240432|NCT01248013|E1|Reported Event|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
240401|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240402|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240403|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and Technetium-99m (99mTc) sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240404|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and Technetium-99m (99mTc) sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240405|NCT01248221|E2|Reported Event|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240452|NCT01247675|B3|Baseline|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
240406|NCT01248221|E1|Reported Event|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
240407|NCT01248130|B3|Baseline|Total|Total of all reporting groups
240408|NCT01248130|B2|Baseline|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
240409|NCT01248130|B1|Baseline|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
240410|NCT01248130|P2|Participant Flow|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
240411|NCT01248130|P1|Participant Flow|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
240433|NCT01247974|B3|Baseline|Total|Total of all reporting groups
240434|NCT01247974|B2|Baseline|Control|No closure of pericardium
240412|NCT01248130|O2|Outcome|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
240413|NCT01248130|O1|Outcome|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
240414|NCT01248130|E2|Reported Event|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
241783|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
240415|NCT01248130|E1|Reported Event|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
240416|NCT01248065|B3|Baseline|Total|Total of all reporting groups
240417|NCT01248065|B2|Baseline|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)
Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
240418|NCT01248065|B1|Baseline|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
240419|NCT01248065|P2|Participant Flow|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)
Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
240420|NCT01248065|P1|Participant Flow|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
240421|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)
Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
240422|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
240423|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)
Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
240424|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
240425|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)
Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
240426|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
240427|NCT01248065|E2|Reported Event|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)
Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
240428|NCT01248065|E1|Reported Event|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
240429|NCT01248013|B1|Baseline|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
240430|NCT01248013|P1|Participant Flow|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
240431|NCT01248013|O1|Outcome|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
240479|NCT01247571|B1|Baseline|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
240435|NCT01247974|B1|Baseline|CorMatrix® ECM®|CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
240436|NCT01247974|P2|Participant Flow|Control|Pericardium is not closed
240437|NCT01247974|P1|Participant Flow|CorMatrix® ECM®|CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
240438|NCT01247974|O2|Outcome|Control|No Pericardial Closure
240439|NCT01247974|O1|Outcome|CorMatrix ECM for Pericardial Closure|Pericardial closure with CorMatrix ECM
240440|NCT01247974|O2|Outcome|Control|No Pericardial Closure
240441|NCT01247974|O1|Outcome|CorMatrix ECM for Pericardial Closure|Pericardial closure with CorMatrix ECM
240442|NCT01247974|E2|Reported Event|Control|Pericardium is not closed
240443|NCT01247974|E1|Reported Event|CorMatrix ECM|CorMatrix ECM for Pericardial Closure
240444|NCT01247922|B1|Baseline|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
240445|NCT01247922|P1|Participant Flow|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
240446|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
240447|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
240448|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
240449|NCT01247922|E1|Reported Event|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
240450|NCT01247675|B5|Baseline|Total|Total of all reporting groups
240451|NCT01247675|B4|Baseline|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
240454|NCT01247675|B1|Baseline|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
240455|NCT01247675|P4|Participant Flow|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: subcutaneous, daily injection of Omnitrope equivalent to 0.04 mg/kg/wk over 4 weeks. Prior to randomization, study subjects entered a wash out period of 14 to 21 days following cessation of daily growth hormone therapy.
240456|NCT01247675|P3|Participant Flow|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.08 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
240457|NCT01247675|P2|Participant Flow|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.04 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
240458|NCT01247675|P1|Participant Flow|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.02 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
240459|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
240460|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk
240461|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk
240462|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
240463|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
240464|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
240465|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
240466|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
240467|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
240468|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
240469|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
240470|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
240471|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
240472|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
240473|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
240474|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
240475|NCT01247675|E4|Reported Event|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
240476|NCT01247675|E3|Reported Event|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk
240477|NCT01247675|E2|Reported Event|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
240478|NCT01247675|E1|Reported Event|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
241940|NCT01242527|E3|Reported Event|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
240481|NCT01247571|O1|Outcome|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
240482|NCT01247571|O1|Outcome|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
240483|NCT01247571|O1|Outcome|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
240484|NCT01247571|O1|Outcome|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
240485|NCT01247571|O1|Outcome|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
240486|NCT01247571|E1|Reported Event|Pazopanib|Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
240487|NCT01247428|B1|Baseline|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240488|NCT01247428|P1|Participant Flow|MiStent SES|The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240489|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240490|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240491|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240492|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
241784|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
240493|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240494|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240495|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240496|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240497|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240498|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240499|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240500|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240501|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240502|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240503|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240504|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240505|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240506|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240507|NCT01247428|E1|Reported Event|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
240508|NCT01247324|B3|Baseline|Total|Total of all reporting groups
240509|NCT01247324|B2|Baseline|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240510|NCT01247324|B1|Baseline|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240511|NCT01247324|P2|Participant Flow|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240512|NCT01247324|P1|Participant Flow|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240513|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240514|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240515|NCT01247324|O1|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240623|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
240516|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240517|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240518|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240519|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240520|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240521|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240522|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240523|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240524|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240525|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240526|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240527|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240528|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240529|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240530|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240531|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240532|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240533|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240534|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240535|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240536|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240537|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240538|NCT01247324|O2|Outcome|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240539|NCT01247324|O1|Outcome|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240540|NCT01247324|E2|Reported Event|Ocrelizumab|Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
240541|NCT01247324|E1|Reported Event|Interferon Beta-1a 44 mcg SC|Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
240542|NCT01247298|B1|Baseline|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.
Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
240543|NCT01247298|P1|Participant Flow|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.
Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
240624|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
298162|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1
240544|NCT01247298|O1|Outcome|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.
Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
240545|NCT01247298|O1|Outcome|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.
Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
240546|NCT01247298|O1|Outcome|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.
Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
240547|NCT01247298|O1|Outcome|Stereotactic Body Radiation Therapy (SBRT)|"Patients will receive stereotactic body radiation therapy (SBRT) which is 3 radiation treatments at 15 Gy, for a total of 45 Gy. Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. (TACE is not performed as part of this clinical study, even though it is part of the inclusion criteria.)
Stereotactic Body Radiation Therapy (SBRT): This investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy."
240548|NCT01247298|O1|Outcome|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.
Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
240549|NCT01247298|E1|Reported Event|TACE + SBRT|"Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.
Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin."
240550|NCT01247285|B3|Baseline|Total|Total of all reporting groups
240551|NCT01247285|B2|Baseline|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
240552|NCT01247285|B1|Baseline|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
240553|NCT01247285|P2|Participant Flow|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
240554|NCT01247285|P1|Participant Flow|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
240555|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
240556|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
240557|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
240558|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
240559|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
240560|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
240561|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
240562|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
240563|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
240564|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
240565|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
240566|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
240567|NCT01247285|E2|Reported Event|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in either period.
240568|NCT01247285|E1|Reported Event|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
240569|NCT01247272|B3|Baseline|Total|Total of all reporting groups
240570|NCT01247272|B2|Baseline|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
240571|NCT01247272|B1|Baseline|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
240572|NCT01247272|P2|Participant Flow|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
240573|NCT01247272|P1|Participant Flow|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
240574|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
240575|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
240625|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
240576|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
240577|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
240578|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
240579|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
240580|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
240581|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
240582|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
240583|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
240584|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
240585|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
240586|NCT01247272|E2|Reported Event|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
240587|NCT01247272|E1|Reported Event|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
240590|NCT01247220|B1|Baseline|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg
Peripheral Laser: Angiography-directed peripheral laser"
240591|NCT01247220|P2|Participant Flow|Ranibizumab|"Ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
240592|NCT01247220|P1|Participant Flow|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg
Peripheral Laser: Angiography-directed peripheral laser"
240593|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
240594|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg
Peripheral Laser: Angiography-directed peripheral laser"
240595|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
240596|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg
Peripheral Laser: Angiography-directed peripheral laser"
240597|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
240598|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg
Peripheral Laser: Angiography-directed peripheral laser"
240599|NCT01247220|E2|Reported Event|Ranibizumab|"Ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
240600|NCT01247220|E1|Reported Event|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab
Ranibizumab: Intravitreal Ranibizumab 0.5 mg
Peripheral Laser: Angiography-directed peripheral laser"
240601|NCT01247090|B4|Baseline|Total|Total of all reporting groups
240602|NCT01247090|B3|Baseline|Placebo|No Dose - Placebo Comparator
240603|NCT01247090|B2|Baseline|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
240604|NCT01247090|B1|Baseline|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
240605|NCT01247090|P3|Participant Flow|Placebo|No Dose - Placebo Comparator
240606|NCT01247090|P2|Participant Flow|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
240607|NCT01247090|P1|Participant Flow|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
240608|NCT01247090|O3|Outcome|Placebo|No Dose - Placebo Comparator
240609|NCT01247090|O2|Outcome|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
240610|NCT01247090|O1|Outcome|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
240611|NCT01247090|E3|Reported Event|Placebo|No Dose - Placebo Comparator
240612|NCT01247090|E2|Reported Event|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
240613|NCT01247090|E1|Reported Event|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
240614|NCT01247064|B3|Baseline|Total|Total of all reporting groups
240615|NCT01247064|B2|Baseline|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
240616|NCT01247064|B1|Baseline|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
240617|NCT01247064|P2|Participant Flow|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
240618|NCT01247064|P1|Participant Flow|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
240619|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
240620|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
240621|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
240622|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
240626|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
240627|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
240628|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
240629|NCT01247064|E2|Reported Event|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
240630|NCT01247064|E1|Reported Event|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
240631|NCT01246999|B5|Baseline|Total|Total of all reporting groups
240632|NCT01246999|B4|Baseline|LAIV - TIV|LAIV will be given followed by TIV 28 days later
240633|NCT01246999|B3|Baseline|TIV - TIV|TIV will be given followed by TIV 28 days later
240634|NCT01246999|B2|Baseline|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later
Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
240635|NCT01246999|B1|Baseline|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later
Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
240636|NCT01246999|P4|Participant Flow|TIV - TIV|TIV will be given IM followed by TIV IM
240637|NCT01246999|P3|Participant Flow|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
240638|NCT01246999|P2|Participant Flow|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later
Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
240639|NCT01246999|P1|Participant Flow|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later
Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
240640|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
240641|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
240642|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later
Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
240643|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later
Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
240644|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
240645|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
240646|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later
Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
240647|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later
Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
240648|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
240649|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
240650|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later
Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
240651|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later
Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
240652|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
240653|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
240654|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later
Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
240655|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later
Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
240656|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
240657|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
240658|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later
Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
241089|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
240659|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later
Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
240660|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
240661|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
240662|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later
Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
240663|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later
Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
240664|NCT01246999|O3|Outcome|All First Dose Live Vaccine|All subjects who received LAIV as a first dose
240665|NCT01246999|O2|Outcome|Seasonal Influenza Vaccine (TIV-LAIV)|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later
Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
240666|NCT01246999|O1|Outcome|Trivalent Seasonal Live Attenuated Influenza Vaccine|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later
Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
240667|NCT01246999|E4|Reported Event|TIV-TIV|TIV will be given IM followed by IV IM
240668|NCT01246999|E3|Reported Event|LAIV-TIV|LAIV will be given intranasally followed by TIV intramuscularly
240669|NCT01246999|E2|Reported Event|TIV-LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later
Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
240670|NCT01246999|E1|Reported Event|LAIV-LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later
Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
240671|NCT01246973|B3|Baseline|Total|Total of all reporting groups
240672|NCT01246973|B2|Baseline|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
240673|NCT01246973|B1|Baseline|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
240674|NCT01246973|P2|Participant Flow|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
240675|NCT01246973|P1|Participant Flow|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
240676|NCT01246973|O2|Outcome|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
240677|NCT01246973|O1|Outcome|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
240678|NCT01246973|O2|Outcome|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
240679|NCT01246973|O1|Outcome|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
240680|NCT01246973|E2|Reported Event|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
240681|NCT01246973|E1|Reported Event|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
240682|NCT01246960|B3|Baseline|Total|Total of all reporting groups
240683|NCT01246960|B2|Baseline|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240684|NCT01246960|B1|Baseline|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240685|NCT01246960|P2|Participant Flow|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin 85 mg/m^2
Leucovorin 400 mg/m^2
5-FU 400 mg/m^2 bolus
5-FU 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240686|NCT01246960|P1|Participant Flow|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 milligrams per kilogram (mg/kg) intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering modified FOLFOX6 (mFOLFOX6).
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin 85 milligrams per square meter (mg/m^2)
Leucovorin 400 mg/m^2
5-Fluorouracil (5-FU) 400 mg/m^2 bolus
5-FU 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240687|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240688|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240689|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240690|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240691|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240692|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240693|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240694|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240695|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240696|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240871|NCT01245738|P1|Participant Flow|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240697|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240698|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240699|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240700|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240891|NCT01245647|P1|Participant Flow|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
240701|NCT01246960|E2|Reported Event|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240702|NCT01246960|E1|Reported Event|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
Oxaliplatin: 85 mg/m^2
Leucovorin: 400 mg/m^2
5-FU: 400 mg/m^2 bolus
5-FU: 2400 mg/m^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
240703|NCT01246791|B1|Baseline|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240704|NCT01246791|P1|Participant Flow|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240705|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240706|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240707|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240708|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240709|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240710|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240711|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240712|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240713|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240714|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240715|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240716|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240717|NCT01246791|E1|Reported Event|NPC-01|"Single oral administration of NPC-01
NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
240718|NCT01246713|B1|Baseline|All Study Participants|All study participants received a 15mg/kg dose of a solid acetaminophen formulation and a 15mg/kg dose of a liquid acetaminophen formulation separated by at least a 2 week washout period.
298163|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
240719|NCT01246713|P2|Participant Flow|Liquid Acetaminophen First, Then Solid Acetaminophen|Study participants randomized to receive liquid formulation first. They received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
240720|NCT01246713|P1|Participant Flow|Solid Acetaminophen First, Then Liquid Acetaminophen|Study participants randomized to receive solid formulation first. They received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
240721|NCT01246713|O2|Outcome|Acetaminophen Liquid Formulation|Subjects in this arm will receive a 15mg/kg dose of a liquid acetaminophen formulation. Results for APAP-cysteinate metabolite
240722|NCT01246713|O1|Outcome|Acetaminophen Solid Formulation|Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation. Results for APAP-cysteinate metabolite
240723|NCT01246713|E2|Reported Event|Liquid Acetaminophen First, Then Solid Acetaminophen|Participants in arm Liquid Acetaminophen First: received a single 15mg/kg dose of a liquid acetaminophen formulation, and then a 15mg/kg dose of a solid acetaminophen formulation after a 2 week washout period.
240724|NCT01246713|E1|Reported Event|Solid Acetaminophen First, Then Liquid Acetaminophen|Participants in arm Solid Acetaminophen First: received a single 15mg/kg dose of a solid acetaminophen formulation first, and then a 15mg/kg dose of a liquid acetaminophen formulation after a 2 week washout period.
240725|NCT01246479|B1|Baseline|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety
Blood draw: blood draw at Month 12, Month 24 and Month 36.
IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
240726|NCT01246479|P1|Participant Flow|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety
Blood draw: blood draw at Month 12, Month 24 and Month 36.
IC51 has given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
286006|NCT00114517|B2|Baseline|Early Postmenopause Placebo|
240727|NCT01246479|O1|Outcome|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety
Blood draw: blood draw at Month 12, Month 24 and Month 36.
IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
240728|NCT01246479|E1|Reported Event|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety
Blood draw: blood draw at Month 12, Month 24 and Month 36.
IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
240729|NCT01246401|B3|Baseline|Total|Total of all reporting groups
240730|NCT01246401|B2|Baseline|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240731|NCT01246401|B1|Baseline|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240732|NCT01246401|P2|Participant Flow|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240733|NCT01246401|P1|Participant Flow|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240734|NCT01246401|O2|Outcome|4 or More XR-NTX Injections|All participants who received 4 or more XR-NTX injections
240735|NCT01246401|O1|Outcome|Placebo + Participants With 3 or Fewer XR-NTX Injections|All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections
240736|NCT01246401|O2|Outcome|4 or More XR-NTX Injections|All participants who received 4 or more XR-NTX injections
240737|NCT01246401|O1|Outcome|Placebo + Participants With 3 or Fewer XR-NTX Injections|All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections
240738|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240739|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240740|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240741|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240742|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240743|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240744|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240745|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240746|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240747|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240748|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240749|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240750|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240751|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240892|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
240752|NCT01246401|O2|Outcome|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240753|NCT01246401|O1|Outcome|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240754|NCT01246401|E2|Reported Event|Placebo|"Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240755|NCT01246401|E1|Reported Event|Extended-Release Naltrexone|"Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg"
240756|NCT01246349|B3|Baseline|Total|Total of all reporting groups
240757|NCT01246349|B2|Baseline|Control (Social Skills Training)|"The control group received social skills training in place of Motivational Interviewing (MI). The social skills training was provided by a therapist who was not trained in MI to avoid cross-contamination.
The social skills training provided was a standardized and manualized treatment, developed and validated for children and adolescents. As part of this training, the interventionist offered advice and clients were assigned specific tasks to work on. No consideration of clients’ readiness to change was made in this group."
240758|NCT01246349|B1|Baseline|Treatment Group (Motivational Interviewing)|"The treatment group received Motivational Interviewing (MI), which is a client-centered, directive method of therapy aimed at enhancing a client’s intrinsic motivation to change by exploring and resolving ambivalence.
MI utilizes strategies to guide the patient, as opposed to offering advice or focusing on accomplishing specific goals. For example, using reflective listening and shared decision making are common within the MI approach.
Six individual MI sessions, approximately 30 minutes in length each, were provided by a trained clinical psychology doctoral student."
240759|NCT01246349|P2|Participant Flow|Treatment/Experimental Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.
A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
240760|NCT01246349|P1|Participant Flow|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.
The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
240761|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.
A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
240762|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.
The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
240763|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.
A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
240764|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.
The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
240765|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.
A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
240766|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.
The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
240767|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.
A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
240768|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.
The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
240769|NCT01246349|E2|Reported Event|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.
A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
240770|NCT01246349|E1|Reported Event|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.
The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
240771|NCT01246258|B1|Baseline|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
240772|NCT01246258|P1|Participant Flow|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
240773|NCT01246258|O1|Outcome|Test Group|"Standard tests of balance function
Vestibular evoked myogenic potentials (VEMPs): Standard test of balance function
Utricular centrifugation test: Standard test of balance function"
240774|NCT01246258|O1|Outcome|Test Group|VEMPs
240775|NCT01246258|E1|Reported Event|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
240811|NCT01245764|B3|Baseline|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
241941|NCT01242527|E2|Reported Event|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
240776|NCT01246206|B1|Baseline|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
240777|NCT01246206|P1|Participant Flow|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
240778|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
240779|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
240893|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
240780|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
240781|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
240782|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
240783|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
240784|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
240812|NCT01245764|B2|Baseline|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
240872|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
241090|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
240785|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
240786|NCT01246206|E1|Reported Event|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
240787|NCT01246076|B1|Baseline|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.
Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
240788|NCT01246076|P1|Participant Flow|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.
Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
240789|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.
Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
240790|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.
Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
240791|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.
Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
240792|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.
Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
240793|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.
Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
240794|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.
Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
240795|NCT01246076|E1|Reported Event|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.
Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
240796|NCT01246011|B4|Baseline|Total|Total of all reporting groups
240797|NCT01246011|B3|Baseline|Heparin PF4 Antibody Negative|
240798|NCT01246011|B2|Baseline|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
240799|NCT01246011|B1|Baseline|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
240800|NCT01246011|P3|Participant Flow|Heparin PF4 Antibody Negative|
240801|NCT01246011|P2|Participant Flow|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
240802|NCT01246011|P1|Participant Flow|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
240803|NCT01246011|O3|Outcome|Heparin PF4 Antibody Negative|
240804|NCT01246011|O2|Outcome|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
240805|NCT01246011|O1|Outcome|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
240806|NCT01246011|E3|Reported Event|Heparin PF4 Antibody Negative|
240807|NCT01246011|E2|Reported Event|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
240808|NCT01246011|E1|Reported Event|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
240809|NCT01245764|B5|Baseline|Total|Total of all reporting groups
240810|NCT01245764|B4|Baseline|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
240845|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
241091|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
240813|NCT01245764|B1|Baseline|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
240814|NCT01245764|P4|Participant Flow|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
240815|NCT01245764|P3|Participant Flow|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
240816|NCT01245764|P2|Participant Flow|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
240817|NCT01245764|P1|Participant Flow|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
240818|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240819|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240820|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240821|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240822|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240823|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240824|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
240825|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
240894|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
243490|NCT01237327|P2|Participant Flow|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
240826|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
240827|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation will continue to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
240828|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
240829|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
240830|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to match GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240831|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240832|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240833|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240834|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to match GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240835|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240836|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240837|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240838|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240839|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240840|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240841|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240842|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240843|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
240844|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
298164|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1
240846|NCT01245764|E4|Reported Event|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B.
240847|NCT01245764|E3|Reported Event|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
240848|NCT01245764|E2|Reported Event|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
240849|NCT01245764|E1|Reported Event|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
240850|NCT01245751|B5|Baseline|Total|Total of all reporting groups
240851|NCT01245751|B4|Baseline|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240852|NCT01245751|B3|Baseline|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240853|NCT01245751|B2|Baseline|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240854|NCT01245751|B1|Baseline|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240855|NCT01245751|P4|Participant Flow|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240856|NCT01245751|P3|Participant Flow|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240857|NCT01245751|P2|Participant Flow|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
241785|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
240858|NCT01245751|P1|Participant Flow|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240859|NCT01245751|O4|Outcome|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240860|NCT01245751|O3|Outcome|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240861|NCT01245751|O2|Outcome|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240862|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004(NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240863|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004(NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240864|NCT01245751|O2|Outcome|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240865|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240866|NCT01245751|E4|Reported Event|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240867|NCT01245751|E3|Reported Event|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240868|NCT01245751|E2|Reported Event|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240869|NCT01245751|E1|Reported Event|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
240870|NCT01245738|B1|Baseline|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
298165|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
240873|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240874|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240875|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240876|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240877|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240878|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240879|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240880|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240881|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240882|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240883|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240884|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240885|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240886|NCT01245738|E1|Reported Event|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
240887|NCT01245647|B3|Baseline|Total|Total of all reporting groups
240888|NCT01245647|B2|Baseline|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
240889|NCT01245647|B1|Baseline|Sugar Pill, 50mg, Once a Day for 4 Months|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
240890|NCT01245647|P2|Participant Flow|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
240895|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
240896|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
240897|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
240898|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
240899|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
240900|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
240901|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
240902|NCT01245647|E2|Reported Event|Naltrexone, 50mg Pill Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
240903|NCT01245647|E1|Reported Event|Sugar Pill, 50 mg Once a Day for 4 Months|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
240904|NCT01245595|B3|Baseline|Total|Total of all reporting groups
240905|NCT01245595|B2|Baseline|Placebo|"Normal Saline Placebo
Placebo: Normal Saline"
240906|NCT01245595|B1|Baseline|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
240907|NCT01245595|P2|Participant Flow|Placebo|"Normal Saline Placebo
Placebo: Normal Saline"
240908|NCT01245595|P1|Participant Flow|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
240909|NCT01245595|O2|Outcome|Placebo|"Normal Saline Placebo
Placebo: Normal Saline"
240910|NCT01245595|O1|Outcome|Aminophylline|"Patients to receive aminophylline 5 mg/kg intravenous (IV) bolus then 1.8 mg/kg IV every six (Q6) hours
Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
240911|NCT01245595|E2|Reported Event|Placebo|"Normal Saline Placebo
Placebo: Normal Saline"
240912|NCT01245595|E1|Reported Event|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
240913|NCT01245439|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240914|NCT01245439|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
298166|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
240915|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240916|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240917|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240918|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240919|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240920|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240921|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240922|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240923|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240924|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240925|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240926|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240927|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240928|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240929|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240930|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240931|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240932|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240957|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
298167|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
240933|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current (DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240934|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240935|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240936|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240937|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240938|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240939|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240940|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240969|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240941|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240942|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240943|NCT01245439|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
240944|NCT01245413|B1|Baseline|Entire Study Population|Entire study population = all participlants enrolled in the study
240945|NCT01245413|P2|Participant Flow|Athena Adhesive|Athena =the new test product. The Athena in this trails is an adhesive. The intend use is collecting output from a stoma (e.g an ileostomy and colostomy).
240946|NCT01245413|P1|Participant Flow|SenSura Adhesive|Sensura is an already commercially available baseplate. Designed to collect output from a stoma(e.g an ileostomy and colostomy).
240947|NCT01245413|O2|Outcome|Athena Adhesive|New test adhesive
240948|NCT01245413|O1|Outcome|SenSura Adhesive|Reference adhesive which is commercially available.
240949|NCT01245413|E2|Reported Event|Athena Adhesive|Base-plate adhesion to skin
240950|NCT01245413|E1|Reported Event|SenSura Adhesive|base-plate adhesion to skin
240951|NCT01245387|B1|Baseline|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240952|NCT01245387|P1|Participant Flow|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240953|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240954|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240955|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240956|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
241081|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
240958|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240959|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240960|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240961|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240962|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240963|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240964|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240965|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240966|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240967|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240968|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
241115|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
286007|NCT00114517|B1|Baseline|Early Postmenopause 17B-estradiol|
240970|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240971|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240972|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240973|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240974|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240975|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240976|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240977|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240978|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240979|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240980|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240981|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240982|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240983|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
241082|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
240984|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240985|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240986|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240987|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240988|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240989|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240990|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240991|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240992|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240993|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240994|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240995|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
241786|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
240996|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240997|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240998|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
240999|NCT01245387|E1|Reported Event|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
241000|NCT01245374|B1|Baseline|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
241001|NCT01245374|P1|Participant Flow|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
241002|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
241003|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
241004|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
241005|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
241006|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
241007|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
241008|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
241009|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
241010|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
241011|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
241012|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
241013|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
241014|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
241015|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
241016|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
241017|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
241018|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
241019|NCT01245374|E1|Reported Event|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
241020|NCT01245283|B4|Baseline|Total|Total of all reporting groups
241021|NCT01245283|B3|Baseline|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
241022|NCT01245283|B2|Baseline|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
241023|NCT01245283|B1|Baseline|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
241024|NCT01245283|P3|Participant Flow|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
241025|NCT01245283|P2|Participant Flow|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
241026|NCT01245283|P1|Participant Flow|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
241027|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241028|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241029|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
241030|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241031|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241032|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
241942|NCT01242527|E1|Reported Event|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
241033|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241034|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241035|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
241036|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241037|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241038|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
241039|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241040|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241041|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
241042|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241043|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241044|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
241116|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241045|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241046|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241047|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
241048|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241049|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
241050|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
241051|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
241052|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
241053|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
241083|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241084|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241085|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241054|NCT01245283|E3|Reported Event|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
241055|NCT01245283|E2|Reported Event|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
241056|NCT01245283|E1|Reported Event|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
241057|NCT01245270|B3|Baseline|Total|Total of all reporting groups
241058|NCT01245270|B2|Baseline|Control Capsule First, Then Bilberry Capsule|In a cross-over design, eight volunteers were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
241059|NCT01245270|B1|Baseline|Bilberry Capsule First, Then Control Capsule|In a cross-over design, eight volunteers were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
241117|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241118|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241119|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
287297|NCT00109031|B5|Baseline|Total|Total of all reporting groups
241060|NCT01245270|P2|Participant Flow|Single Bilberry Capsule First Then Control Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
241061|NCT01245270|P1|Participant Flow|Single Control Capsule First Then Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
241062|NCT01245270|O2|Outcome|Single Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
241086|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241087|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241088|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241943|NCT01242514|B4|Baseline|Total|Total of all reporting groups
241063|NCT01245270|O1|Outcome|Single Control Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
241064|NCT01245270|O2|Outcome|Single Blaeberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
241065|NCT01245270|O1|Outcome|Single Placebo Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
241066|NCT01245270|E2|Reported Event|Single Placebo Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
241120|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241121|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241122|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241123|NCT01245140|E2|Reported Event|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241124|NCT01245140|E1|Reported Event|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241125|NCT01245101|B3|Baseline|Total|Total of all reporting groups
245193|NCT01231607|B5|Baseline|Placebo|Matching dutasteride placebo and finasteride placebo once daily
241067|NCT01245270|E1|Reported Event|Single Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
241068|NCT01245140|B3|Baseline|Total|Total of all reporting groups
241069|NCT01245140|B2|Baseline|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241070|NCT01245140|B1|Baseline|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241071|NCT01245140|P2|Participant Flow|Alitretinoin 30 mg|Participants received an alitretinoin 30 milligram (mg) capsule orally QD for up to 24 weeks.
241072|NCT01245140|P1|Participant Flow|Matching Placebo|Participants received matching placebo orally once daily (QD) for up to 24 weeks.
241073|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241074|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241075|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241076|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241077|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241078|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241079|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241080|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
246292|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn.
241092|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241093|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241094|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241095|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241096|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241097|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241098|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241099|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241100|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241101|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241102|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241103|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241104|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241105|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241106|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241107|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241108|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241109|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241110|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241111|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241112|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241113|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
241114|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
241126|NCT01245101|B2|Baseline|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
241127|NCT01245101|B1|Baseline|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
241128|NCT01245101|P2|Participant Flow|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
241129|NCT01245101|P1|Participant Flow|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
241130|NCT01245101|O2|Outcome|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
241131|NCT01245101|O1|Outcome|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
241132|NCT01245101|O2|Outcome|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
241133|NCT01245101|O1|Outcome|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
241134|NCT01245101|E2|Reported Event|Observation|Observation for 16 weeks
241135|NCT01245101|E1|Reported Event|Raltegravir|Raltegravir 400 mg twice a day for 16 weeks
241136|NCT01245062|B3|Baseline|Total|Total of all reporting groups
241137|NCT01245062|B2|Baseline|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241138|NCT01245062|B1|Baseline|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signalling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241139|NCT01245062|P3|Participant Flow|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
241140|NCT01245062|P2|Participant Flow|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241141|NCT01245062|P1|Participant Flow|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signalling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241563|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241142|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
241143|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
241144|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241145|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241146|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241147|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241148|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
241149|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241150|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241151|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241152|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241153|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241154|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241155|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241156|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241157|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241158|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241260|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241261|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241159|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241160|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241161|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241162|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241163|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241164|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241165|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241166|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241238|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241787|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241167|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241168|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241169|NCT01245062|E3|Reported Event|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
241170|NCT01245062|E2|Reported Event|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
241171|NCT01245062|E1|Reported Event|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signalling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
241172|NCT01245049|B3|Baseline|Total|Total of all reporting groups
241173|NCT01245049|B2|Baseline|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241174|NCT01245049|B1|Baseline|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241564|NCT01244490|O1|Outcome|Placebo|Once daily
298168|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
241175|NCT01245049|P2|Participant Flow|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241176|NCT01245049|P1|Participant Flow|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241177|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241178|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241179|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241180|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241239|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241240|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241181|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241182|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241183|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241184|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241185|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241262|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241263|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241565|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241186|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241187|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241188|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241189|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241190|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241191|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241192|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241241|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241242|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241193|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241194|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241195|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241196|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241197|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241198|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241199|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241200|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241201|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241202|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241203|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241204|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241243|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241244|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241205|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241206|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241207|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241208|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241209|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241210|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241211|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241212|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241213|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241214|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241215|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241216|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241245|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241281|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241217|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241218|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241219|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241220|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241221|NCT01245049|O2|Outcome|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241222|NCT01245049|O1|Outcome|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241223|NCT01245049|E2|Reported Event|Repevax Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
241224|NCT01245049|E1|Reported Event|Boostrix Polio Group|Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
241225|NCT01244984|B4|Baseline|Total|Total of all reporting groups
241226|NCT01244984|B3|Baseline|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241227|NCT01244984|B2|Baseline|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241228|NCT01244984|B1|Baseline|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241229|NCT01244984|P3|Participant Flow|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241230|NCT01244984|P2|Participant Flow|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241231|NCT01244984|P1|Participant Flow|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg ) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241232|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241233|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241234|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241235|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241236|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241237|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241788|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241246|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241247|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241248|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241249|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241250|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241251|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241252|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241253|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241254|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241255|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241256|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241257|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241258|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241259|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241264|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241265|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241266|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241267|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241268|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241269|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241270|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241271|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241272|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241273|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241274|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241275|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241276|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241277|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241278|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241279|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241280|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241789|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241282|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241283|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241284|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241285|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241286|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241287|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241288|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241289|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241290|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241291|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241292|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241293|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241294|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241295|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241296|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241297|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241298|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241299|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241300|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241301|NCT01244984|E3|Reported Event|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
241302|NCT01244984|E2|Reported Event|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
241303|NCT01244984|E1|Reported Event|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
241304|NCT01244906|B1|Baseline|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
241305|NCT01244906|P1|Participant Flow|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
241306|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
241307|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
289079|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
241308|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
241309|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
241310|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
241311|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
241312|NCT01244906|E1|Reported Event|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
241374|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241461|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241326|NCT01244828|B1|Baseline|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241347|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241327|NCT01244828|P1|Participant Flow|Asenapine|All participants receive asenapine 5 mg twice daily (BID) for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241328|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241329|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241330|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241331|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241332|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241333|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241334|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241335|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241336|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241337|NCT01244828|E1|Reported Event|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
241338|NCT01244815|B5|Baseline|Total|Total of all reporting groups
241339|NCT01244815|B4|Baseline|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241340|NCT01244815|B3|Baseline|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241341|NCT01244815|B2|Baseline|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241342|NCT01244815|B1|Baseline|Placebo|Participants receive placebo BID for 21 days.
241404|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241343|NCT01244815|P4|Participant Flow|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241344|NCT01244815|P3|Participant Flow|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241345|NCT01244815|P2|Participant Flow|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241346|NCT01244815|P1|Participant Flow|Placebo|Participants receive placebo twice daily (BID) for 21 days.
241409|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
289080|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
241348|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241349|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241350|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241351|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241352|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241353|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241354|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241355|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241356|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241357|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241358|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241359|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241360|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241361|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241362|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241363|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241364|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241365|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241366|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241367|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241368|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241369|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241370|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241371|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241372|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241373|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
298169|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
241375|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241376|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241377|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241378|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241410|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241790|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241379|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241380|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241381|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241382|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241383|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241384|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241385|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241386|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241387|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241388|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241389|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241390|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241391|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241392|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241393|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241394|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241395|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241396|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241397|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241398|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241399|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241400|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241401|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241402|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241403|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
298170|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
241407|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241408|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241411|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241412|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241413|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241414|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
241415|NCT01244815|E4|Reported Event|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
241416|NCT01244815|E3|Reported Event|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
241417|NCT01244815|E2|Reported Event|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
241418|NCT01244815|E1|Reported Event|Placebo|Participants receive placebo BID for 21 days.
241419|NCT01244724|B1|Baseline|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
241420|NCT01244724|P1|Participant Flow|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
241421|NCT01244724|O1|Outcome|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
241422|NCT01244724|E1|Reported Event|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
241423|NCT01244711|B1|Baseline|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.
quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
241424|NCT01244711|P1|Participant Flow|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.
quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
241425|NCT01244711|O1|Outcome|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.
quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
241426|NCT01244711|E1|Reported Event|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.
quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
241427|NCT01244633|B1|Baseline|Ecopipam|"Active treatment
Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
241428|NCT01244633|P1|Participant Flow|Ecopipam|"Active treatment
Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
241429|NCT01244633|O1|Outcome|Ecopipam|"Active treatment
Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
241430|NCT01244633|E1|Reported Event|Ecopipam|"Active treatment
Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
241431|NCT01244620|B1|Baseline|Entire Study Population|All randomized participants
241432|NCT01244620|P4|Participant Flow|Sitax and Sild, Then Sitax and Tad, Then Tad, Then Sitax|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
241433|NCT01244620|P3|Participant Flow|Sitax and Tad, Then Sitax, Then Sitax and Sild, Then Tad|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
300764|NCT00160199|B1|Baseline|Prometrium 300 mg/Day|
241434|NCT01244620|P2|Participant Flow|Tad, Then Sitax and Sild, Then Sitax, Then Sitax and Tad|Tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
241465|NCT01244620|E3|Reported Event|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days
241466|NCT01244620|E2|Reported Event|Tadalafil|Tadalafil 40 mg tablet QD for 6 days
289081|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
241435|NCT01244620|P1|Participant Flow|Sitax, Then Tad, Then Sitax and Tad, Then Sitax and Sild|Sitaxsentan 100 milligram (mg) tablet once daily (QD) for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table three times daily (TID) for 6 days. Only the first treatment in the sequence was administered due to the early termination.
241436|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241437|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241438|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241439|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241440|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241441|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241442|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241443|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241444|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241445|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241446|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241447|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241448|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241449|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241450|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241451|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241452|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241453|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241454|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241455|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241456|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241457|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241458|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241459|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241460|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241562|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241462|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241463|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
241464|NCT01244620|E4|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days
289082|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
241468|NCT01244529|B1|Baseline|All Subjects|All subjects who where enrolled wore all intervention lenses throughout the course of the study. The specific lenses used include the following: senofilcon A (control) soft contact lens with 8.8 base; senofilcon A (control) soft contact lens with 8.4 base curve; galyfilcon A (control) soft contact lens with 8.7 base curve; galyfilcon A (control) soft contact lens with 8.3 base curve; galyfilcon A Plus (test) soft contact lens with 8.7 base curve; galyfilcon A Plus (test) soft contact lens with 8.3 base curve.
241469|NCT01244529|P1|Participant Flow|All Arms, All Interventions|All subjects wore all intervention throughout the course of the study.
241470|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC vs Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241471|NCT01244529|O3|Outcome|Galyfilcon AP 8.7 BC vs Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241472|NCT01244529|O2|Outcome|Galyfilcon AP 8.3 BC vs Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241473|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC vs Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241474|NCT01244529|O6|Outcome|Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241475|NCT01244529|O5|Outcome|Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241476|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241477|NCT01244529|O3|Outcome|Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241478|NCT01244529|O2|Outcome|Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241479|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241480|NCT01244529|O6|Outcome|Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241481|NCT01244529|O5|Outcome|Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241482|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241483|NCT01244529|O3|Outcome|Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241484|NCT01244529|O2|Outcome|Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241485|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241486|NCT01244529|O3|Outcome|Senofilcon A|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241487|NCT01244529|O2|Outcome|Galyfilcon A (Control)|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241488|NCT01244529|O1|Outcome|Galyfilcon A Plus (Test)|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
241489|NCT01244529|E1|Reported Event|All Arms, All Interventions|All subjects wore all intervention throughout the course of the study.
241490|NCT01244516|B4|Baseline|Total|Total of all reporting groups
241491|NCT01244516|B3|Baseline|BIO (Biofinity)|Subjects that were randomized to wear Biofinity lens throughout the course of the study.
241492|NCT01244516|B2|Baseline|AOA (Air Optic)|Subjects that were randomized to wear AOA lens throughout the course of the study.
241493|NCT01244516|B1|Baseline|AAHP (Acuvue)|Subjects that were randomized to wear AAHP lens throughout the course of the study.
241494|NCT01244516|P3|Participant Flow|Comfilcon A|comfilcon A, base curve 8.60
241495|NCT01244516|P2|Participant Flow|Lotrafilcon B|lotrafilcon B, base curve 8.60
241496|NCT01244516|P1|Participant Flow|Galyfilcon A|galyfilcon A base curve 8.30
241497|NCT01244516|O2|Outcome|Comfilcon A (BIO)|comfilcon A, base curve 8.60
241498|NCT01244516|O1|Outcome|Galyfilcon A (AAPA)|galyfilcon A base curve 8.30
241499|NCT01244516|O3|Outcome|Comfilcon A (BIO)|comfilcon A, base curve 8.60
241500|NCT01244516|O2|Outcome|Lotrafilcon B (AOA)|lotrafilcon B, base curve 8.60
241501|NCT01244516|O1|Outcome|Galyfilcon A (AAPA)|galyfilcon A base curve 8.30
241502|NCT01244516|O3|Outcome|Comfilcon A (BIO)|comfilcon A, base curve 8.60
241503|NCT01244516|O2|Outcome|Lotrafilcon B (AOA)|lotrafilcon B, base curve 8.60
241504|NCT01244516|O1|Outcome|Galyfilcon A (AAPA)|galyfilcon A base curve 8.30
241505|NCT01244516|E3|Reported Event|Comfilcon A|comfilcon A, base curve 8.60
241506|NCT01244516|E2|Reported Event|Lotrafilcon B|lotrafilcon B, base curve 8.60
241507|NCT01244516|E1|Reported Event|Galyfilcon A|galyfilcon A base curve 8.30
241508|NCT01244503|B1|Baseline|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.
Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
241509|NCT01244503|P1|Participant Flow|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.
Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
300765|NCT00160199|P2|Participant Flow|Prometrium 400 mg/Day|
241510|NCT01244503|O1|Outcome|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.
Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
241572|NCT01244477|B2|Baseline|Arm 2|Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
241605|NCT01244425|E2|Reported Event|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
241511|NCT01244503|O1|Outcome|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.
Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
241512|NCT01244503|E1|Reported Event|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.
Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
241513|NCT01244490|B4|Baseline|Total|Total of all reporting groups
241514|NCT01244490|B3|Baseline|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241515|NCT01244490|B2|Baseline|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241516|NCT01244490|B1|Baseline|Placebo|Once daily
241517|NCT01244490|P3|Participant Flow|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241518|NCT01244490|P2|Participant Flow|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241519|NCT01244490|P1|Participant Flow|Placebo|Once daily
241520|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241521|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241522|NCT01244490|O1|Outcome|Placebo|Once daily
241523|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241524|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241525|NCT01244490|O1|Outcome|Placebo|Once daily
241526|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241527|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241528|NCT01244490|O1|Outcome|Placebo|Once daily
241529|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241530|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241531|NCT01244490|O1|Outcome|Placebo|Once daily
241532|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241533|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241534|NCT01244490|O1|Outcome|Placebo|Once daily
241535|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241536|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241537|NCT01244490|O1|Outcome|Placebo|Once daily
241538|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241539|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241540|NCT01244490|O1|Outcome|Placebo|Once daily
241541|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241542|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241543|NCT01244490|O1|Outcome|Placebo|Once daily
241544|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241545|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241546|NCT01244490|O1|Outcome|Placebo|Once daily
241547|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241548|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241549|NCT01244490|O1|Outcome|Placebo|Once daily
241550|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241551|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241552|NCT01244490|O1|Outcome|Placebo|Once daily
241553|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241554|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241555|NCT01244490|O1|Outcome|Placebo|Once daily
241556|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241557|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241558|NCT01244490|O1|Outcome|Placebo|Once daily
241559|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241560|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241561|NCT01244490|O1|Outcome|Placebo|Once daily
241566|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
241567|NCT01244490|O1|Outcome|Placebo|Once daily
241568|NCT01244490|E3|Reported Event|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
241573|NCT01244477|B1|Baseline|Arm 1|"Participants in group CPT-C
Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks."
241574|NCT01244477|P2|Participant Flow|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
241575|NCT01244477|P1|Participant Flow|CPT-C|Group Cognitive Processing Therapy-C (CPT-C): Participants who chose to participate in a 12-week CPT-C treatment group.
241576|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
241577|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C
Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
241578|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
241579|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C
Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
241580|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
241581|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C
Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
241582|NCT01244477|E2|Reported Event|Treatment-as-Usual|Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
241583|NCT01244477|E1|Reported Event|CPT-C|"Participants in group CPT-C
Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks."
241584|NCT01244425|B3|Baseline|Total|Total of all reporting groups
241585|NCT01244425|B2|Baseline|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
241586|NCT01244425|B1|Baseline|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
241587|NCT01244425|P2|Participant Flow|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
241588|NCT01244425|P1|Participant Flow|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
241589|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
241590|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
241591|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
241592|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
241593|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
241594|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
241595|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
241596|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
241597|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 10 minutes after application of the study treatment.
241598|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 10 minutes after application of the study treatment.
241599|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 8 minutes after application of the study treatment.
241600|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 8 minutes after application of the study treatment.
241601|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 6 minutes after application of the study treatment.
241602|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 6 minutes after application of the study treatment.
241603|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 4 minutes after application of the study treatment.
241604|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4 minutes after application of the study treatment.
241729|NCT01243450|B1|Baseline|Active Generic|Active generic group
241606|NCT01244425|E1|Reported Event|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
241607|NCT01244412|B1|Baseline|Imaged Subjects|
241608|NCT01244412|P1|Participant Flow|Imaged Subjects|Subjects imaged with hand held device
241609|NCT01244412|O1|Outcome|Imaged Subjects|
241610|NCT01244412|E1|Reported Event|Imaged Subjects|
241611|NCT01244243|B1|Baseline|Active Therapy|"All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
Hand & Wrist Assisting Robotic Device: Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks."
241612|NCT01244243|P1|Participant Flow|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
241613|NCT01244243|O1|Outcome|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
241614|NCT01244243|O1|Outcome|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
241615|NCT01244243|E1|Reported Event|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
241616|NCT01244126|B4|Baseline|Total|Total of all reporting groups
241617|NCT01244126|B3|Baseline|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
241618|NCT01244126|B2|Baseline|IV Morphine|0.1 mg/kg morphine IV
241619|NCT01244126|B1|Baseline|IM Morphine|0.1 mg/kg morphine IM
241620|NCT01244126|P3|Participant Flow|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
241621|NCT01244126|P2|Participant Flow|IV Morphine|0.1 mg/kg morphine IV
241622|NCT01244126|P1|Participant Flow|IM Morphine|0.1 mg/kg morphine IM
241623|NCT01244126|O3|Outcome|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
241624|NCT01244126|O2|Outcome|IV Morphine|0.1 mg/kg morphine IV
241625|NCT01244126|O1|Outcome|IM Morphine|0.1 mg/kg morphine IM
241626|NCT01244126|O3|Outcome|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
241627|NCT01244126|O2|Outcome|IV Morphine|0.1 mg/kg morphine IV
241628|NCT01244126|O1|Outcome|IM Morphine|0.1 mg/kg morphine IM
241629|NCT01244126|E3|Reported Event|IV Morphine|0.1 mg/kg morphine IV
241630|NCT01244126|E2|Reported Event|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
241631|NCT01244126|E1|Reported Event|IM Morphine|0.1 mg/kg morphine IM
241632|NCT01244061|B3|Baseline|Total|Total of all reporting groups
241633|NCT01244061|B2|Baseline|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
241634|NCT01244061|B1|Baseline|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
241635|NCT01244061|P2|Participant Flow|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
241636|NCT01244061|P1|Participant Flow|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
241637|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
241638|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
241639|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
241640|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
241641|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
241642|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
241643|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
241644|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
241645|NCT01244061|E2|Reported Event|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
300766|NCT00160199|P1|Participant Flow|Prometrium 300 mg/Day|
241646|NCT01244061|E1|Reported Event|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
241647|NCT01243944|B3|Baseline|Total|Total of all reporting groups
241730|NCT01243450|P3|Participant Flow|Brand|Tretinoin: Topical skin
241648|NCT01243944|B2|Baseline|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
241649|NCT01243944|B1|Baseline|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241650|NCT01243944|P2|Participant Flow|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
241651|NCT01243944|P1|Participant Flow|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg once a day (QD) to 25 mg BID based on safety and efficacy
241652|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241653|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
241654|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241655|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
241656|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241657|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241658|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
241659|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241660|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
241661|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241662|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
241663|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241664|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
241665|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241666|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
241667|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241668|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
241669|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241670|NCT01243944|E2|Reported Event|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
241671|NCT01243944|E1|Reported Event|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
241672|NCT01243892|B3|Baseline|Total|Total of all reporting groups
241673|NCT01243892|B2|Baseline|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241674|NCT01243892|B1|Baseline|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241675|NCT01243892|P2|Participant Flow|ISS Participants|Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241676|NCT01243892|P1|Participant Flow|IGHD Participants|Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid [DNA] origin) (recombinant human growth hormone [rhGH]) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241677|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241678|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241679|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241680|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241681|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241682|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241683|NCT01243892|E2|Reported Event|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241684|NCT01243892|E1|Reported Event|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
241685|NCT01243775|B1|Baseline|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
241686|NCT01243775|P1|Participant Flow|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
241687|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
241688|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
241689|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
241690|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
241691|NCT01243775|E1|Reported Event|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
241692|NCT01243671|B1|Baseline|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241693|NCT01243671|P1|Participant Flow|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241694|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241695|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241696|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241697|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241698|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241699|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241700|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241731|NCT01243450|P2|Participant Flow|Placebo|"placebo cream
Tretinoin: Topical skin
placebo"
241701|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241702|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241703|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241704|NCT01243671|E1|Reported Event|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
241705|NCT01243619|B1|Baseline|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
241706|NCT01243619|P1|Participant Flow|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
241707|NCT01243619|O1|Outcome|All Participants|"All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
All patients accepted and complied with having three sets of PET scans performed (six total PET scans).
The software used in this protocol has allowed quantitative comparison among the PET scans."
241708|NCT01243619|E1|Reported Event|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
241709|NCT01243567|B3|Baseline|Total|Total of all reporting groups
241710|NCT01243567|B2|Baseline|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241711|NCT01243567|B1|Baseline|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241712|NCT01243567|P2|Participant Flow|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241713|NCT01243567|P1|Participant Flow|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241714|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241715|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241716|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241717|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241718|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241719|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241720|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241721|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241722|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241723|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241724|NCT01243567|E2|Reported Event|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241725|NCT01243567|E1|Reported Event|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
241726|NCT01243450|B4|Baseline|Total|Total of all reporting groups
241727|NCT01243450|B3|Baseline|Placebo|Placebo group
241728|NCT01243450|B2|Baseline|Brand|Brand group
241739|NCT01243411|B1|Baseline|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241740|NCT01243411|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241741|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241742|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241743|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241744|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241745|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241746|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241747|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241748|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241749|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241750|NCT01243411|E1|Reported Event|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
241751|NCT01243320|B1|Baseline|All Study Participants|10 ppm Silver, then 32 ppm Silver
241752|NCT01243320|P1|Participant Flow|All Study Participants|Study had two dosing phases. All study participants were assigned the 10ppm Oral Silver and proceed to the 32 pm Oral Silver.
241753|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241754|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241755|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241756|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241757|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241758|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241759|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241760|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241761|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241762|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241763|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241764|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241765|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241766|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241767|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241768|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241769|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241770|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241771|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241772|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241773|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241774|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241775|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241776|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241777|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241778|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241856|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
241779|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241780|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241781|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241782|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
245194|NCT01231607|B4|Baseline|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
241791|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241792|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241793|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241794|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241795|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241796|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241797|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241798|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241799|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241800|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241801|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241802|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241803|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241804|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241805|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241806|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241807|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241808|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241809|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241810|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241811|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241812|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241813|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241814|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241815|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241816|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241817|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241818|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241819|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241820|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241821|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241822|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241823|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
241824|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
241825|NCT01243320|E2|Reported Event|32ppm Oral Solution|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
241826|NCT01243320|E1|Reported Event|10ppm Oral Solution|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
241827|NCT01243294|B1|Baseline|Entire Study Population|Includes groups randomized to receive SS (new ostomy bag)first and SenSura first
241828|NCT01243294|P2|Participant Flow|SS First, Then SenSura|"SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.
SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241829|NCT01243294|P1|Participant Flow|SenSura First, Then SS|"SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.
SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241830|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241857|NCT01243242|E2|Reported Event|Placebo|Eligible subjects who received 1400 mg of Placebo
241858|NCT01243242|E1|Reported Event|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
241859|NCT01243177|B3|Baseline|Total Title|
241831|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241861|NCT01243177|B1|Baseline|Lacosamide|"Strengths: 50 mg / 100 mg
Form: tablets
Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
Duration: up to 118 weeks"
241966|NCT01242371|B2|Baseline|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
241832|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241833|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241834|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241835|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241836|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241837|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241838|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241839|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241840|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241841|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.
Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.
The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
241842|NCT01243294|E2|Reported Event|SS (New Ostomy Bag)|Base plates applied 1 till 6 times a day SS = new ostomy bag
241843|NCT01243294|E1|Reported Event|SenSura|Base plates applied 1 till 6 times a day
241844|NCT01243242|B3|Baseline|Total|Total of all reporting groups
241845|NCT01243242|B2|Baseline|Placebo|Eligible subjects who received 1400 mg of Placebo
241846|NCT01243242|B1|Baseline|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
241847|NCT01243242|P2|Participant Flow|Placebo|Eligible subjects who received 1400 mg of Placebo
241848|NCT01243242|P1|Participant Flow|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
241849|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
241850|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
241851|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
241852|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
241853|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
241854|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
241855|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
241860|NCT01243177|B2|Baseline|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg
Form: tablets
Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
Duration: up to 118 weeks"
241944|NCT01242514|B3|Baseline|Fostamatinib 100 mg qd|Oral treatment
241945|NCT01242514|B2|Baseline|Fostamatinib 150 mg qd|Oral treatment
241862|NCT01243177|P2|Participant Flow|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg
Form: tablets
Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
Duration: up to 118 weeks"
241863|NCT01243177|P1|Participant Flow|Lacosamide|"Strengths: 50 mg / 100 mg
Form: tablets
Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
Duration: up to 118 weeks"
241864|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg
Form: tablets
Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
Duration: up to 118 weeks"
241865|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg
Form: tablets
Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
Duration: up to 118 weeks"
241866|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg
Form: tablets
Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
Duration: up to 118 weeks"
241867|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg
Form: tablets
Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
Duration: up to 118 weeks"
241868|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg
Form: tablets
Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
Duration: up to 118 weeks"
241869|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg
Form: tablets
Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
Duration: up to 118 weeks"
241870|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg
Form: tablets
Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
Duration: up to 118 weeks"
241871|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg
Form: tablets
Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
Duration: up to 118 weeks"
241872|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg
Form: tablets
Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
Duration: up to 118 weeks"
241873|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg
Form: tablets
Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
Duration: up to 118 weeks"
241874|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg
Form: tablets
Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
Duration: up to 118 weeks"
241875|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg
Form: tablets
Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
Duration: up to 118 weeks"
241876|NCT01243177|E2|Reported Event|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg
Form: tablets
Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
Duration: up to 118 weeks"
241877|NCT01243177|E1|Reported Event|Lacosamide|"Strengths: 50 mg / 100 mg
Form: tablets
Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
Duration: up to 118 weeks"
241878|NCT01243112|B1|Baseline|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
241879|NCT01243112|P1|Participant Flow|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
241880|NCT01243112|O1|Outcome|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
241881|NCT01243112|O1|Outcome|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
241882|NCT01243112|E1|Reported Event|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
241883|NCT01242813|B1|Baseline|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241931|NCT01242527|P4|Participant Flow|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
241932|NCT01242527|P3|Participant Flow|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
241933|NCT01242527|P2|Participant Flow|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
241884|NCT01242813|P1|Participant Flow|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 milligram/ kilogram (mg/kg) for participants equal to or less than (≤) 40 kg or 150 mg for participants more than (>) 40 kg) through subcutaneous (s.c.) route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TNF-receptor associated periodic syndrome (TRAPS) flare.
241885|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241886|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241887|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241888|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241889|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241890|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241891|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241892|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241893|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241894|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241895|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241896|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241897|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241898|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241899|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241900|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241901|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241902|NCT01242813|E1|Reported Event|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
241903|NCT01242748|B3|Baseline|Total|Total of all reporting groups
241934|NCT01242527|P1|Participant Flow|Olive Oil (Placebo Control)|placebo : 4 capsules (1g) daily for 12 weeks
241935|NCT01242527|O4|Outcome|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
241904|NCT01242748|B2|Baseline|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
241946|NCT01242514|B1|Baseline|Fostamatinib 100 mg Bid|Oral treatment
241947|NCT01242514|P3|Participant Flow|Fostamatinib 100 mg qd|Oral treatment
241948|NCT01242514|P2|Participant Flow|Fostamatinib 150 mg qd|Oral treatment
241949|NCT01242514|P1|Participant Flow|Fostamatinib 100 mg Bid|Oral treatment
241950|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
241905|NCT01242748|B1|Baseline|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
241906|NCT01242748|P2|Participant Flow|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
241907|NCT01242748|P1|Participant Flow|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
241908|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
241909|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
241910|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
241911|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
241912|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
241913|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
241914|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
241936|NCT01242527|O3|Outcome|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
241937|NCT01242527|O2|Outcome|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
241938|NCT01242527|O1|Outcome|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
241915|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
241916|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
241951|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
241952|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
241953|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
241917|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
241918|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
241919|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
241920|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
241921|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
241922|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
241923|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
241924|NCT01242748|E2|Reported Event|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
241925|NCT01242748|E1|Reported Event|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
241926|NCT01242527|B5|Baseline|Total|Total of all reporting groups
241927|NCT01242527|B4|Baseline|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
241928|NCT01242527|B3|Baseline|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
241929|NCT01242527|B2|Baseline|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
241930|NCT01242527|B1|Baseline|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
300767|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
241967|NCT01242371|B1|Baseline|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
241968|NCT01242371|P2|Participant Flow|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
241969|NCT01242371|P1|Participant Flow|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
241970|NCT01242371|O2|Outcome|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
241971|NCT01242371|O1|Outcome|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
241972|NCT01242371|E2|Reported Event|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
241973|NCT01242371|E1|Reported Event|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
241974|NCT01242176|B1|Baseline|Study Overall|"An open-label, randomised, two-way crossover study. The two treatments administered were
A single dose of empagliflozin (empa) 25mg, final formulation
A single dose of empa 25mg, trial formulation 2
Between drug administrations there was a washout period of at least 7 days."
241975|NCT01242176|P2|Participant Flow|Empa TF2 / Empa FF|Single dose of 25mg empagliflozin (empa) trial formulation 2 (TF2) followed by a single dose of 25mg of empa final formulation (FF), with a washout period of at least 7 days between treatments.
241976|NCT01242176|P1|Participant Flow|Empa FF / Empa TF2|Single dose of 25mg of empagliflozin (empa) final formulation (FF) followed by a single dose of 25mg empa trial formulation 2 (TF2), with a washout period of at least 7 days between treatments.
241977|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
241978|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
241979|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
241980|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
241981|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
241982|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
241983|NCT01242176|E2|Reported Event|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
241984|NCT01242176|E1|Reported Event|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
241985|NCT01242111|B1|Baseline|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
241986|NCT01242111|P1|Participant Flow|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
241987|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
241988|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
241989|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
241990|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
241991|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
241992|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
241993|NCT01242111|E1|Reported Event|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
241994|NCT01242085|B4|Baseline|Total|Total of all reporting groups
241995|NCT01242085|B3|Baseline|Both Interventions|one participant had bilateral knee replacement with one control knee and one trumatch knee
241996|NCT01242085|B2|Baseline|Trumatch Group|patients randomized to study instrumentation
241997|NCT01242085|B1|Baseline|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement
study group will have customized knee instruments : CT based customized knee instruments"
241998|NCT01242085|P3|Participant Flow|Both Interventions|one participant had both interventions - one for each knee
241999|NCT01242085|P2|Participant Flow|Control Group|control group will have standard instrumentation of their knee replacement
242000|NCT01242085|P1|Participant Flow|Trumatch Group|trumatch group will have customized knee instruments : CT based customized knee instruments
242001|NCT01242085|O2|Outcome|Trumatch Group|patients randomized to study instrumentation
242002|NCT01242085|O1|Outcome|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement
study group will have customized knee instruments : CT based customized knee instruments"
242003|NCT01242085|O2|Outcome|Trumatch Group|patients randomized to study instrumentation
242004|NCT01242085|O1|Outcome|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement
study group will have customized knee instruments : CT based customized knee instruments"
242005|NCT01242085|E2|Reported Event|Trumatch Group|patients randomized to study instrumentation
242006|NCT01242085|E1|Reported Event|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement
study group will have customized knee instruments : CT based customized knee instruments"
242007|NCT01242020|B3|Baseline|Total|Total of all reporting groups
242060|NCT01241591|B5|Baseline|Total|Total of all reporting groups
289083|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
242008|NCT01242020|B2|Baseline|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
242009|NCT01242020|B1|Baseline|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
242010|NCT01242020|P2|Participant Flow|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
242011|NCT01242020|P1|Participant Flow|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
242012|NCT01242020|O2|Outcome|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
242013|NCT01242020|O1|Outcome|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
242014|NCT01242020|O2|Outcome|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
242015|NCT01242020|O1|Outcome|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
242016|NCT01242020|E2|Reported Event|Obese Healthy Subjects|"Obese grade I-II defined as (BMI>30 and ≤35)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
242017|NCT01242020|E1|Reported Event|Lean Healthy Subjects|"Lean defined as (BMI ≥18 and ≤25)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used"
242018|NCT01241916|B3|Baseline|Total|Total of all reporting groups
242019|NCT01241916|B2|Baseline|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
242020|NCT01241916|B1|Baseline|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
242021|NCT01241916|P2|Participant Flow|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
242022|NCT01241916|P1|Participant Flow|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
242023|NCT01241916|O2|Outcome|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
242024|NCT01241916|O1|Outcome|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
242025|NCT01241916|O2|Outcome|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
242026|NCT01241916|O1|Outcome|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
242027|NCT01241916|E2|Reported Event|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
242028|NCT01241916|E1|Reported Event|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
242029|NCT01241903|B3|Baseline|Total|Total of all reporting groups
242030|NCT01241903|B2|Baseline|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
242031|NCT01241903|B1|Baseline|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
242032|NCT01241903|P2|Participant Flow|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
242033|NCT01241903|P1|Participant Flow|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
242034|NCT01241903|O2|Outcome|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
242035|NCT01241903|O1|Outcome|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
242036|NCT01241903|E2|Reported Event|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
242037|NCT01241903|E1|Reported Event|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
242038|NCT01241760|B3|Baseline|Total|Total of all reporting groups
242039|NCT01241760|B2|Baseline|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242258|NCT01241565|P1|Participant Flow|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
242040|NCT01241760|B1|Baseline|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242041|NCT01241760|P2|Participant Flow|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242042|NCT01241760|P1|Participant Flow|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242043|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242044|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242045|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242046|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242047|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242048|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242049|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242050|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242051|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242052|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242053|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242054|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242055|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242056|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242057|NCT01241760|E3|Reported Event|Total|All
242058|NCT01241760|E2|Reported Event|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242059|NCT01241760|E1|Reported Event|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
242061|NCT01241591|B4|Baseline|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242062|NCT01241591|B3|Baseline|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242063|NCT01241591|B2|Baseline|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242064|NCT01241591|B1|Baseline|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242065|NCT01241591|P4|Participant Flow|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242066|NCT01241591|P3|Participant Flow|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242067|NCT01241591|P2|Participant Flow|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242068|NCT01241591|P1|Participant Flow|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242069|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242070|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242071|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242072|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242073|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242074|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242075|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242076|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242077|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242078|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242079|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242080|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242081|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242082|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242083|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242084|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242085|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242086|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242087|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242088|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
289084|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
242089|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242090|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242091|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242092|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242093|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242094|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242095|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242096|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242097|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242098|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242099|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242100|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242101|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242102|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242103|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242104|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242105|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242106|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242107|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242108|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242109|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242110|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242111|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242112|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242113|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242114|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242115|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242116|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
245195|NCT01231607|B3|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
242117|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242118|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242119|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242120|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242121|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242122|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242123|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242124|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242125|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242126|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242127|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242128|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242129|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242130|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242131|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242132|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242133|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242134|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242135|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242136|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242137|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242138|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242139|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242140|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242141|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242142|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242143|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242144|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
245196|NCT01231607|B2|Baseline|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
242145|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242146|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242147|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242148|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242149|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242150|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242151|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242152|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242153|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242154|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242155|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242156|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242157|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242158|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242159|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242160|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242161|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242162|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242163|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242164|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242165|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242166|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242167|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242168|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242169|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242170|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242171|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242172|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
246022|NCT01229397|E1|Reported Event|Inflexal V 0.25 mL x 2 - After 1st Vaccination|
242173|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242174|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242175|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242176|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242177|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242178|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242179|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242180|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242181|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242182|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242183|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242184|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242185|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242186|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242187|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242188|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242189|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242190|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242191|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242192|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242193|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242194|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242195|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242196|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242197|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242198|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242199|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242200|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
246023|NCT01229371|B5|Baseline|Total|Total of all reporting groups
242201|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242202|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242203|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242204|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242205|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242206|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242207|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242208|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242209|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242210|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242211|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242212|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242213|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242214|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242215|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242216|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242217|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242218|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242219|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242220|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242221|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242222|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242223|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242224|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242225|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242226|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242227|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242228|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
246024|NCT01229371|B4|Baseline|Subjects >60 Years - CSL HA Antigen|
242229|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242230|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242231|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242232|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242233|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242234|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242235|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242236|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242237|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242238|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242239|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242240|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242241|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242242|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242243|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242244|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242245|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242246|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242247|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242248|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242249|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242250|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242251|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242252|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242253|NCT01241591|E4|Reported Event|Placebo|Participants received matching placebo tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242254|NCT01241591|E3|Reported Event|Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242255|NCT01241591|E2|Reported Event|CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242256|NCT01241591|E1|Reported Event|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
242257|NCT01241565|B1|Baseline|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
242259|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.
ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
242260|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.
ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
242261|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.
ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
242262|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.
ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
242263|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.
ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
242264|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
242265|NCT01241565|E1|Reported Event|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
242266|NCT01241552|B5|Baseline|Total|Total of all reporting groups
242267|NCT01241552|B4|Baseline|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242268|NCT01241552|B3|Baseline|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242269|NCT01241552|B2|Baseline|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242270|NCT01241552|B1|Baseline|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242271|NCT01241552|P4|Participant Flow|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242272|NCT01241552|P3|Participant Flow|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242273|NCT01241552|P2|Participant Flow|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242274|NCT01241552|P1|Participant Flow|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care (SOC) for CDI
242275|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242276|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242277|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242278|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242279|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242280|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242281|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242282|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242283|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242284|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242285|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242286|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242287|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242288|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242289|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242290|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242291|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242292|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242293|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242294|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242295|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242296|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242297|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242298|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242299|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242300|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242301|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242302|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242303|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242304|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242305|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242306|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242307|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
246025|NCT01229371|B3|Baseline|Subjects >60 Years - AdImmune HA Antigen|
242308|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242309|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242310|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242311|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242312|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242313|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242314|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242315|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242316|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242317|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242318|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242319|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242320|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242321|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242322|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242323|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242324|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242325|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242326|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242327|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242328|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242329|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242330|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242331|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
242332|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
242333|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
242334|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
242335|NCT01241552|E4|Reported Event|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + SOC for CDI
242336|NCT01241552|E3|Reported Event|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
242337|NCT01241552|E2|Reported Event|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
242338|NCT01241552|E1|Reported Event|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + SOC for CDI
242339|NCT01241539|B1|Baseline|Dabigatran|Dabigatran treated patients
242340|NCT01241539|P1|Participant Flow|Dabigatran|Period 1 target blood flow rate during dialysis was 200mL/min. Period 2 target blood flow rate during dialysis was 400mL/min.
242341|NCT01241539|O1|Outcome|Dabigatran|Dabigatran treated patients
242342|NCT01241539|O1|Outcome|Dabigatran|Dabigatran treated patients
242343|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
242344|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
242345|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
242346|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
242347|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
242348|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
242349|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
242350|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
242351|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
242352|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
242353|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
242354|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
242355|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
242356|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
242357|NCT01241539|E1|Reported Event|Dabigatran|Dabigatran treated patients
242358|NCT01241513|B3|Baseline|Total|Total of all reporting groups
242359|NCT01241513|B2|Baseline|Placebo|Placebo
242360|NCT01241513|B1|Baseline|N-acetylcysteine (NAC)|NAC
242361|NCT01241513|P2|Participant Flow|Placebo|Placebo
242362|NCT01241513|P1|Participant Flow|N-acetylcysteine|Active drug group
242363|NCT01241513|O2|Outcome|NAC Group|N-acetyl-L-Cysteine (800 mg T.I.D. in diet soda) for 4 days
242364|NCT01241513|O1|Outcome|Placebo Group|Placebo (Diet soda only)
242365|NCT01241513|E1|Reported Event|NAC Group and Placebo Group|
242366|NCT01241292|B3|Baseline|Total|Total of all reporting groups
242403|NCT01241240|B2|Baseline|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
242367|NCT01241292|B2|Baseline|Elotuzumab 20 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242368|NCT01241292|B1|Baseline|Elotuzumab 10 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242369|NCT01241292|P2|Participant Flow|Elotuzumab 20 mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
242370|NCT01241292|P1|Participant Flow|Elotuzumab 10 mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
242371|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242372|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242373|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
242374|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
242435|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242375|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242376|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242377|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242378|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242379|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242380|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242381|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242382|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242383|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
246026|NCT01229371|B2|Baseline|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
242384|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242385|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242386|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242387|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of:
28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242388|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.
Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.
On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of:
28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
242389|NCT01241292|E2|Reported Event|Elotuzumab 20mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
242390|NCT01241292|E1|Reported Event|Elotuzumab 10mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
242391|NCT01241279|B3|Baseline|Total|Total of all reporting groups
242392|NCT01241279|B2|Baseline|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
242393|NCT01241279|B1|Baseline|Crystalens AO|A silicone multi-piece accommodating intraocular lens
242394|NCT01241279|P2|Participant Flow|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
242395|NCT01241279|P1|Participant Flow|Crystalens AO|A silicone multi-piece accommodating intraocular lens
242396|NCT01241279|O2|Outcome|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
242397|NCT01241279|O1|Outcome|Crystalens AO|A silicone multi-piece accommodating intraocular lens
242398|NCT01241279|O2|Outcome|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
242399|NCT01241279|O1|Outcome|Crystalens AO|A silicone multi-piece accommodating intraocular lens
242400|NCT01241279|E2|Reported Event|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
242401|NCT01241279|E1|Reported Event|Crystalens AO|A silicone multi-piece accommodating intraocular lens
242402|NCT01241240|B3|Baseline|Total|Total of all reporting groups
242404|NCT01241240|B1|Baseline|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
242405|NCT01241240|P2|Participant Flow|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
242406|NCT01241240|P1|Participant Flow|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
242407|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
242408|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
242409|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
242410|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
242411|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
242412|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
242413|NCT01241240|E2|Reported Event|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
242414|NCT01241240|E1|Reported Event|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
242415|NCT01240915|B9|Baseline|Total|Total of all reporting groups
242416|NCT01240915|B8|Baseline|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242417|NCT01240915|B7|Baseline|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242418|NCT01240915|B6|Baseline|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242419|NCT01240915|B5|Baseline|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242420|NCT01240915|B4|Baseline|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242421|NCT01240915|B3|Baseline|Cohort 1: MultiStem 300 or MultiStem 300 (x3), Placebo|Participants received either a single dose of MultiStem 300 Million Cells infusion on Day 1 or 3 doses on Day 1, Week 1, and Week 2; followed by a single dose of placebo infusion at Week 8.
242422|NCT01240915|B2|Baseline|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242423|NCT01240915|B1|Baseline|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242424|NCT01240915|P9|Participant Flow|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242425|NCT01240915|P8|Participant Flow|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242426|NCT01240915|P7|Participant Flow|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242427|NCT01240915|P6|Participant Flow|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242428|NCT01240915|P5|Participant Flow|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242429|NCT01240915|P4|Participant Flow|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242430|NCT01240915|P3|Participant Flow|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242431|NCT01240915|P2|Participant Flow|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242432|NCT01240915|P1|Participant Flow|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242433|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242434|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242436|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242437|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242438|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242439|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242440|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242441|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242442|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242443|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242444|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242445|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242446|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242447|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242448|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242449|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242450|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242451|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242452|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242453|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242454|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242455|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242456|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242457|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242458|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242459|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242460|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242461|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242462|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242463|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242464|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242465|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242466|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242467|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242468|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
289085|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
242469|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242470|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242471|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242472|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242473|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242474|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242475|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242476|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242477|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242478|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242479|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242480|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242481|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242482|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242483|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242484|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242485|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242486|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242487|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242488|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242489|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242490|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242491|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242492|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242493|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242494|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242495|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242496|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242497|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242498|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242499|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242500|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242501|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
246027|NCT01229371|B1|Baseline|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
242502|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242503|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242504|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242505|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242506|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242507|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242508|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242509|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242510|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242511|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242512|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242513|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242514|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242515|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242516|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242517|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242518|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242519|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242520|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242521|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242522|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242523|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242524|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242525|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242526|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242527|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242528|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242529|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242530|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242531|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242532|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242533|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242534|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242687|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242535|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242536|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242537|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242538|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242539|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242540|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242541|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242542|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242543|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242544|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242545|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242546|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242547|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242548|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242549|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242550|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242551|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242552|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242553|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242554|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242555|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242556|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242557|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242558|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242559|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242560|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242561|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242562|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242563|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242564|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242565|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242566|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242567|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242779|NCT01240785|B3|Baseline|Total|Total of all reporting groups
242568|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242569|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242570|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242571|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242572|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242573|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242574|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242575|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242576|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242577|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242578|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242579|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242580|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242581|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242582|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242583|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242584|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242585|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242586|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242587|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242588|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242589|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242590|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242591|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242592|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242593|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242594|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242595|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
242596|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
242597|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
242598|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
242599|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
242600|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
242601|NCT01240915|E9|Reported Event|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242602|NCT01240915|E8|Reported Event|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242644|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242603|NCT01240915|E7|Reported Event|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242604|NCT01240915|E6|Reported Event|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242605|NCT01240915|E5|Reported Event|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242606|NCT01240915|E4|Reported Event|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
242607|NCT01240915|E3|Reported Event|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
242608|NCT01240915|E2|Reported Event|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
242609|NCT01240915|E1|Reported Event|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
242610|NCT01240902|B5|Baseline|Total|Total of all reporting groups
242611|NCT01240902|B4|Baseline|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242612|NCT01240902|B3|Baseline|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242613|NCT01240902|B2|Baseline|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242614|NCT01240902|B1|Baseline|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242615|NCT01240902|P4|Participant Flow|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242616|NCT01240902|P3|Participant Flow|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242617|NCT01240902|P2|Participant Flow|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242618|NCT01240902|P1|Participant Flow|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242619|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242620|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242621|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242622|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242623|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242624|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242625|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242626|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242627|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242628|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242629|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242630|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242631|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242632|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242633|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242634|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242635|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242636|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242637|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242638|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242639|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242640|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242641|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242642|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242643|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242645|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242646|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242647|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242648|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242649|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242650|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242651|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242652|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242653|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242654|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242655|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242656|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242657|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242658|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242659|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242660|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242661|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242662|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242663|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242664|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242665|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242666|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242667|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242668|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242669|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242670|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242671|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242672|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242673|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242674|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242675|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242676|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242677|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242678|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242679|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242680|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242681|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242682|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242683|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242684|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242685|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242686|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
246028|NCT01229371|P4|Participant Flow|Subjects >60 Years - CSL HA Antigen|
242688|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242689|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242690|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242691|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242692|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242693|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242694|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242695|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242696|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242697|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242698|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242699|NCT01240902|E4|Reported Event|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
242700|NCT01240902|E3|Reported Event|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
242701|NCT01240902|E2|Reported Event|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
242702|NCT01240902|E1|Reported Event|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
242703|NCT01240863|B3|Baseline|Total|Total of all reporting groups
242704|NCT01240863|B2|Baseline|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242705|NCT01240863|B1|Baseline|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242706|NCT01240863|P3|Participant Flow|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242707|NCT01240863|P2|Participant Flow|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242708|NCT01240863|P1|Participant Flow|Hydrocodone ER (Open-Label Titration Period)|All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
242709|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242710|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242711|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242712|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242713|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242714|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242715|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242716|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242717|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242718|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242719|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242720|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242721|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242722|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242723|NCT01240863|O4|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242724|NCT01240863|O3|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242725|NCT01240863|O2|Outcome|Open-Label Titration: Opioid Experienced|"During the open label titration period, all participants received hydrocodone extended release tablets on an open-label basis. Opioid experienced participants switched from their current opioid medications to the calculated dose of hydrocodone extended release tablets based on an equianalgesic dose-conversion scheme.
A decision regarding dose adjustment was made based on whether the criterion of successful dose (ie, dose that produced stable pain relief) was met. In general, dose escalation stepped to 30 mg or 45 mg or 60 mg, or 90 mg every 12 hours until stable pain relief was obtained. The escalated dose was dependent upon the initial calculated equivalent dose."
242726|NCT01240863|O1|Outcome|Open-Label Titration: Opioid Naive|During the open label titration period, all participants received hydrocodone extended release tablets on an open-label basis. Opioid naïve participants (ie, those taking less than 10 mg/day of oxycodone or equivalent, during the 14 days before screening) started at a 15 mg dose of hydrocodone extended release, administered every 12 hours. A decision regarding dose adjustment was made based on whether the criterion of successful dose (ie, dose that produced stable pain relief) was met. In general, dose escalation stepped from 15 mg to 30 mg, 45 mg, 60 mg, and 90 mg every 12 hours until stable pain relief was obtained.
242727|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered ER hydrocodone tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242728|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242729|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242730|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242731|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242732|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242780|NCT01240785|B2|Baseline|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242733|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242734|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242735|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242736|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242737|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242738|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242739|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242740|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242741|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242742|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242743|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242744|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242745|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242746|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242747|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242748|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242749|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242750|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242751|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242781|NCT01240785|B1|Baseline|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242752|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242753|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242754|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242755|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242756|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242757|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242758|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242759|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242760|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242761|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242762|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242763|NCT01240863|E3|Reported Event|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
242764|NCT01240863|E2|Reported Event|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
242765|NCT01240863|E1|Reported Event|Hydrocodone ER (Open-Label Titration Period)|All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
242766|NCT01240811|B4|Baseline|Total|Total of all reporting groups
242767|NCT01240811|B3|Baseline|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
242768|NCT01240811|B2|Baseline|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
242769|NCT01240811|B1|Baseline|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
242770|NCT01240811|P3|Participant Flow|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
242771|NCT01240811|P2|Participant Flow|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
242772|NCT01240811|P1|Participant Flow|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
242773|NCT01240811|O3|Outcome|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
242774|NCT01240811|O2|Outcome|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
242775|NCT01240811|O1|Outcome|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
242776|NCT01240811|E3|Reported Event|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
242777|NCT01240811|E2|Reported Event|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
242778|NCT01240811|E1|Reported Event|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
242784|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242785|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242786|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242787|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242788|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242789|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242790|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242791|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242792|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242793|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242794|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242795|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242796|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242797|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242798|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242799|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242800|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242801|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242802|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242803|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242804|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242805|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242806|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242807|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242808|NCT01240785|E2|Reported Event|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
242809|NCT01240785|E1|Reported Event|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
242810|NCT01240746|B4|Baseline|Total|Total of all reporting groups
242811|NCT01240746|B3|Baseline|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242812|NCT01240746|B2|Baseline|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242813|NCT01240746|B1|Baseline|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242814|NCT01240746|P3|Participant Flow|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242815|NCT01240746|P2|Participant Flow|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242816|NCT01240746|P1|Participant Flow|Study Group 1 (2010-2011 Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen.
242817|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242818|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242819|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242820|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242821|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242822|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242823|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
246029|NCT01229371|P3|Participant Flow|Subjects >60 Years - AdImmune HA Antigen|
242824|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242825|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242826|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242827|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242828|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242829|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242830|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242831|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242832|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242833|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242834|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242835|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242836|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242837|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242838|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242839|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242840|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242841|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242842|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242843|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242844|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242845|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242846|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242847|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242848|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242849|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242850|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242851|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242852|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242853|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242854|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242855|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242856|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242857|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242858|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242859|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242860|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242861|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242862|NCT01240746|E3|Reported Event|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
242863|NCT01240746|E2|Reported Event|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
242864|NCT01240746|E1|Reported Event|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
242865|NCT01240590|B6|Baseline|Total|Total of all reporting groups
242866|NCT01240590|B5|Baseline|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
242867|NCT01240590|B4|Baseline|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
242868|NCT01240590|B3|Baseline|Ph I Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
242869|NCT01240590|B2|Baseline|Ph I Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
242870|NCT01240590|B1|Baseline|Ph I Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
242871|NCT01240590|P5|Participant Flow|Level 4: Cisplatin|100mg/m(2) Cisplatin Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
242872|NCT01240590|P4|Participant Flow|Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
242873|NCT01240590|P3|Participant Flow|Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
242874|NCT01240590|P2|Participant Flow|Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
242875|NCT01240590|P1|Participant Flow|Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
242876|NCT01240590|O5|Outcome|Ph II Level 4: Cisplatin|"100mg/m(2) Cisplatin
Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
242877|NCT01240590|O4|Outcome|Ph II Level 3: Cisplatin + Crolibulin|"100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)
Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
242878|NCT01240590|O3|Outcome|Ph I Level 2: Cisplatin + Crolibulin|"100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)
Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
242879|NCT01240590|O2|Outcome|Ph I Level 1: Cisplatin + Crolibulin|"75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)
Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
242880|NCT01240590|O1|Outcome|Ph I Level -1: Cisplatin + Crolibulin|"75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)
Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
242881|NCT01240590|O5|Outcome|Ph II Level: 4 Cisplatin|100 mg/m(2) Cisplatin
242882|NCT01240590|O4|Outcome|Ph II Level: 3 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
242883|NCT01240590|O3|Outcome|Ph I Level: 2 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
242884|NCT01240590|O2|Outcome|Ph I Level: 1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
242885|NCT01240590|O1|Outcome|Ph I Level: -1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
242886|NCT01240590|O5|Outcome|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
242887|NCT01240590|O4|Outcome|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
242888|NCT01240590|O3|Outcome|Ph I Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
242889|NCT01240590|O2|Outcome|Ph I Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
242890|NCT01240590|O1|Outcome|Ph I Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
242891|NCT01240590|O2|Outcome|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
242892|NCT01240590|O1|Outcome|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
242893|NCT01240590|O1|Outcome|All Participants|All participants who received at least one dose of 8-20 mg/m(2)crolibulin intravenously.
242894|NCT01240590|O1|Outcome|All Participants|All participants who received at least one dose of 75-100 mg/m(2) cisplatin intravenously.
242895|NCT01240590|E5|Reported Event|Ph II Level: 4 Cisplatin|100 mg/m(2) Cisplatin
242896|NCT01240590|E4|Reported Event|Ph II Level: 3 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
242897|NCT01240590|E3|Reported Event|Ph I Level: 2 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
242898|NCT01240590|E2|Reported Event|Ph I Level: 1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
242899|NCT01240590|E1|Reported Event|Ph I Level: -1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
242900|NCT01240551|B3|Baseline|Total|Total of all reporting groups
242901|NCT01240551|B2|Baseline|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
242902|NCT01240551|B1|Baseline|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
242903|NCT01240551|P2|Participant Flow|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
242904|NCT01240551|P1|Participant Flow|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
242905|NCT01240551|O2|Outcome|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
242906|NCT01240551|O1|Outcome|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
242907|NCT01240551|O2|Outcome|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
242908|NCT01240551|O1|Outcome|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
242909|NCT01240551|E2|Reported Event|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
242910|NCT01240551|E1|Reported Event|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
242911|NCT01240382|B3|Baseline|Total|Total of all reporting groups
242912|NCT01240382|B2|Baseline|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
242913|NCT01240382|B1|Baseline|3% DE-089|3% DE-089 ophthalmic solution
242914|NCT01240382|P2|Participant Flow|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
242915|NCT01240382|P1|Participant Flow|3% DE-089|3% DE-089 ophthalmic solution
242916|NCT01240382|O2|Outcome|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
242917|NCT01240382|O1|Outcome|3% DE-089|3% DE-089 ophthalmic solution
242918|NCT01240382|O2|Outcome|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
242919|NCT01240382|O1|Outcome|3% DE-089|3% DE-089 ophthalmic solution
242920|NCT01240382|E2|Reported Event|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
242921|NCT01240382|E1|Reported Event|3% DE-089|3% DE-089 ophthalmic solution
242922|NCT01240356|B3|Baseline|Total|Total of all reporting groups
242923|NCT01240356|B2|Baseline|Phase II|Phase II-20 patients with ischemic stroke treated with IV-tPA
242924|NCT01240356|B1|Baseline|Phase I|Non-stroke volunteers.
242925|NCT01240356|P2|Participant Flow|Phase II|Acute Ischemic Stroke patients received standard-doce intravenous tissue-type plasminogen activator (tPA) within 0-3 hours window.
242926|NCT01240356|P1|Participant Flow|Phase I|Non-stroke volunteers.
242927|NCT01240356|O1|Outcome|Phase I: Healthy Volunteers|Phase I - A group of 15 Non-stroke healthy volunteers.
242928|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
242929|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
242930|NCT01240356|O1|Outcome|Phase II - Iscehmic Stroke Patients|Phase II - 20 patients with ischemic stroke treated with IV-tPA
242931|NCT01240356|O1|Outcome|Phase 1 (Healthy Volunteers)|Phase I - A group of non-stroke healthy volunteers.
242932|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
242933|NCT01240356|O1|Outcome|Phase I|Non stroke patients
242934|NCT01240356|E2|Reported Event|Phase II - Ischemic Stroke Patients|Phase II - 20 patient with ischemic stroke treated with IV-tPA
242935|NCT01240356|E1|Reported Event|Phase I: Healthy Volunteers|Phase I - 15 non-stroke healthy volunteers.
242936|NCT01240330|B1|Baseline|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
242937|NCT01240330|P1|Participant Flow|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
242938|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
242939|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
242940|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
242941|NCT01240330|E1|Reported Event|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
242942|NCT01240200|B3|Baseline|Total|Total of all reporting groups
242943|NCT01240200|B2|Baseline|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Glargine SoloSTAR® pen in Period 1 and Glargine vial and syringe in Period 2.
242944|NCT01240200|B1|Baseline|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Glargine vial and syringe in Period 1 and Glargine SoloSTAR pen in Period 2.
242945|NCT01240200|P2|Participant Flow|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
242946|NCT01240200|P1|Participant Flow|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
242947|NCT01240200|O2|Outcome|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
242948|NCT01240200|O1|Outcome|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
242949|NCT01240200|E2|Reported Event|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
242950|NCT01240200|E1|Reported Event|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
242951|NCT01240135|B3|Baseline|Total|Total of all reporting groups
242952|NCT01240135|B2|Baseline|Renu Fresh / FID 114675A|Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
242953|NCT01240135|B1|Baseline|FID 114576A / Renu Fresh|FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
242954|NCT01240135|P2|Participant Flow|Renu Fresh / FID 114675A|Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
242955|NCT01240135|P1|Participant Flow|FID 114576A / Renu Fresh|FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
242956|NCT01240135|O2|Outcome|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
242957|NCT01240135|O1|Outcome|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
242958|NCT01240135|O2|Outcome|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
242959|NCT01240135|O1|Outcome|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
242960|NCT01240135|E2|Reported Event|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
242961|NCT01240135|E1|Reported Event|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
242962|NCT01240122|B1|Baseline|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
242963|NCT01240122|P1|Participant Flow|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
242964|NCT01240122|O2|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used both the Investigational MPS and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
242965|NCT01240122|O1|Outcome|Biotrue|Paired/parallel eye evaluation; each subject was treated with Biotrue, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
242966|NCT01240122|O2|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used both used the Investigational MPS and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
242967|NCT01240122|O1|Outcome|Biotrue|Paired/parallel eye evaluation; each subject was treated with Biotrue, and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
242968|NCT01240122|E1|Reported Event|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
242969|NCT01239992|B1|Baseline|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
242970|NCT01239992|P1|Participant Flow|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
242971|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
242972|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
242973|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
242974|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
242975|NCT01239992|E1|Reported Event|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
242976|NCT01239797|B3|Baseline|Total|Total of all reporting groups
242977|NCT01239797|B2|Baseline|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
242978|NCT01239797|B1|Baseline|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone (Oral):
On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone (IV):
On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug
Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
242979|NCT01239797|P2|Participant Flow|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
242980|NCT01239797|P1|Participant Flow|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone (Oral):
On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone (IV):
On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug
Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
242981|NCT01239797|O2|Outcome|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
242982|NCT01239797|O1|Outcome|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone (Oral):
On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone (IV):
On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug
Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
242983|NCT01239797|O2|Outcome|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
243043|NCT01239381|P1|Participant Flow|SBRT-Proton|"Stereotactic Body Radiation Therapy (SBRT) by proton radiation
Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
243044|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation
Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
243045|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation
Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
242984|NCT01239797|O1|Outcome|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone (Oral):
On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone (IV):
On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug
Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
242985|NCT01239797|E2|Reported Event|Lenalidomide + Dexamethasone|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
242986|NCT01239797|E1|Reported Event|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone (Oral):
On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug
Dexamethasone (IV):
On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
242987|NCT01239745|B1|Baseline|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
242988|NCT01239745|P1|Participant Flow|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
242989|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
242990|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
242991|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
242992|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
242993|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
242994|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
242995|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
242996|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
242997|NCT01239745|E1|Reported Event|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
242998|NCT01239732|B1|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
243046|NCT01239381|O1|Outcome|SBRT-Proton|"Stereotactic Body Radiation Therapy (SBRT) by proton radiation
Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
243047|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation
Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
243370|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
242999|NCT01239732|P1|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 milligram per square meter (mg/m^2) IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (area under the plasma concentration-time curve [AUC] 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
243000|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
243001|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
243002|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
243003|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
243004|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
243005|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
243006|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
243048|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation
Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
243007|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
243008|NCT01239732|E1|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
243009|NCT01239680|B3|Baseline|Total|Total of all reporting groups
243010|NCT01239680|B2|Baseline|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
243011|NCT01239680|B1|Baseline|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours
243012|NCT01239680|P2|Participant Flow|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
243013|NCT01239680|P1|Participant Flow|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate Intravenous 1 liter once over 6 hours
243014|NCT01239680|O2|Outcome|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
243015|NCT01239680|O1|Outcome|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours.
243016|NCT01239680|E2|Reported Event|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
243017|NCT01239680|E1|Reported Event|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours.
243018|NCT01239511|B5|Baseline|Total|Total of all reporting groups
243019|NCT01239511|B4|Baseline|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
243020|NCT01239511|B3|Baseline|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
243021|NCT01239511|B2|Baseline|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
243022|NCT01239511|B1|Baseline|Placebo Group|placebo capsule 2# t.i.d./day
243023|NCT01239511|P4|Participant Flow|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
243024|NCT01239511|P3|Participant Flow|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
243025|NCT01239511|P2|Participant Flow|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
243026|NCT01239511|P1|Participant Flow|Placebo Group|placebo capsule 2# t.i.d./day
243027|NCT01239511|O4|Outcome|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
243028|NCT01239511|O3|Outcome|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
243029|NCT01239511|O2|Outcome|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
243030|NCT01239511|O1|Outcome|Placebo Group|placebo capsule 2# t.i.d./day
243031|NCT01239511|E4|Reported Event|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
243032|NCT01239511|E3|Reported Event|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
243033|NCT01239511|E2|Reported Event|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
243034|NCT01239511|E1|Reported Event|Placebo Group|placebo capsule 2# t.i.d./day
243035|NCT01239394|B1|Baseline|Ofatumumab|"single-arm, open-label, interventional
ofatumumab: Weekly infusion for 8 weeks"
243036|NCT01239394|P1|Participant Flow|Ofatumumab|"single-arm, open-label, interventional
ofatumumab: Weekly infusion for 8 weeks"
243037|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional
ofatumumab: Weekly infusion for 8 weeks"
243038|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional
ofatumumab: Weekly infusion for 8 weeks"
243039|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional
ofatumumab: Weekly infusion for 8 weeks"
243040|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional
ofatumumab: Weekly infusion for 8 weeks"
243041|NCT01239394|E1|Reported Event|Ofatumumab|"single-arm, open-label, interventional
ofatumumab: Weekly infusion for 8 weeks"
243042|NCT01239381|B1|Baseline|SBRT-Proton|"SBRT by proton radiation
Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
243371|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
243049|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation
Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
243050|NCT01239381|O1|Outcome|SBRT-Proton|"SBRT by proton radiation
Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
243051|NCT01239381|E1|Reported Event|SBRT-Proton|"SBRT by proton radiation
Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks"
243052|NCT01239355|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
243053|NCT01239355|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
243054|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
243055|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
243056|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
243057|NCT01239355|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Akt Inhibitor MK2206: Given PO
Laboratory Biomarker Analysis: Correlative studies"
243058|NCT01239342|B3|Baseline|Total|Total of all reporting groups
243059|NCT01239342|B2|Baseline|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
243060|NCT01239342|B1|Baseline|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
243061|NCT01239342|P2|Participant Flow|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
243062|NCT01239342|P1|Participant Flow|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
243063|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
243064|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
243065|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
243066|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
243067|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
243068|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
243069|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
243070|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
243071|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
243072|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
243073|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
243074|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
243075|NCT01239342|E2|Reported Event|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
243076|NCT01239342|E1|Reported Event|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
243077|NCT01239316|B1|Baseline|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
243078|NCT01239316|P1|Participant Flow|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
243079|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
243080|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
243081|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
243082|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
243083|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
243084|NCT01239316|E1|Reported Event|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
243085|NCT01239212|B1|Baseline|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
243086|NCT01239212|P1|Participant Flow|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
243087|NCT01239212|O1|Outcome|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
243088|NCT01239212|E1|Reported Event|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
243089|NCT01239121|B4|Baseline|Total|Total of all reporting groups
243133|NCT01239043|E2|Reported Event|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
243090|NCT01239121|B3|Baseline|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243091|NCT01239121|B2|Baseline|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
243092|NCT01239121|B1|Baseline|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243093|NCT01239121|P3|Participant Flow|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243094|NCT01239121|P2|Participant Flow|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
243095|NCT01239121|P1|Participant Flow|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243096|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243097|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
243098|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243099|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243100|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
243101|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243102|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243103|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
243104|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243105|NCT01239121|E3|Reported Event|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243106|NCT01239121|E2|Reported Event|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
243107|NCT01239121|E1|Reported Event|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
243108|NCT01239056|B1|Baseline|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
243109|NCT01239056|P1|Participant Flow|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
243110|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
243111|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
243112|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
243113|NCT01239056|E1|Reported Event|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
243114|NCT01239043|B3|Baseline|Total|Total of all reporting groups
243115|NCT01239043|B2|Baseline|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
243116|NCT01239043|B1|Baseline|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
243117|NCT01239043|P2|Participant Flow|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
243118|NCT01239043|P1|Participant Flow|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
243119|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
243120|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
243121|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
243122|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
243123|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
243124|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
243125|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
243126|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
243127|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
243128|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
243129|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
243130|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
243131|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
243132|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
243134|NCT01239043|E1|Reported Event|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
243135|NCT01238991|B11|Baseline|Total|Total of all reporting groups
243136|NCT01238991|B10|Baseline|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243137|NCT01238991|B9|Baseline|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243138|NCT01238991|B8|Baseline|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243139|NCT01238991|B7|Baseline|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243140|NCT01238991|B6|Baseline|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243141|NCT01238991|B5|Baseline|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243142|NCT01238991|B4|Baseline|10 μg ACC-001+ (10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243143|NCT01238991|B3|Baseline|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243144|NCT01238991|B2|Baseline|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243145|NCT01238991|B1|Baseline|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243146|NCT01238991|P10|Participant Flow|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243147|NCT01238991|P9|Participant Flow|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243148|NCT01238991|P8|Participant Flow|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243149|NCT01238991|P7|Participant Flow|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243150|NCT01238991|P6|Participant Flow|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243151|NCT01238991|P5|Participant Flow|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243152|NCT01238991|P4|Participant Flow|10 μg ACC-001+ (10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243153|NCT01238991|P3|Participant Flow|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243154|NCT01238991|P2|Participant Flow|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243155|NCT01238991|P1|Participant Flow|3 μg ACC-001+QS-21|A group of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243156|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
243157|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243158|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243159|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243160|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243161|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243247|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
243162|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243163|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243164|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243165|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243166|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
243167|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243168|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243169|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243170|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243171|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243172|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243173|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243174|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243175|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243176|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
243177|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243178|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243179|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243180|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243181|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243182|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243183|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243184|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243185|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243186|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
243187|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243188|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243189|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243321|NCT01238861|O3|Outcome|Benralizumab, 100 mg|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243190|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243191|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243192|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243193|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243194|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243195|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243196|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
243197|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243198|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243199|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243200|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243201|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243202|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243203|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243204|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243205|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243206|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
243207|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243208|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243209|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243210|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243211|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243212|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243213|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243214|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243215|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243216|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243217|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
289086|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
243218|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243219|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243220|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243221|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243222|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243223|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243224|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243225|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243226|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243227|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243228|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243229|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243230|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243231|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243232|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243233|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243234|NCT01238991|E7|Reported Event|Total|All participants
243235|NCT01238991|E6|Reported Event|30μg Control|A group of participants who received IM injection of adjuvant QS-21(50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243236|NCT01238991|E5|Reported Event|30μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243237|NCT01238991|E4|Reported Event|10μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243238|NCT01238991|E3|Reported Event|10ug ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243239|NCT01238991|E2|Reported Event|3μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and acctive vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
243240|NCT01238991|E1|Reported Event|3μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
243241|NCT01238900|B1|Baseline|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
243242|NCT01238900|P1|Participant Flow|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
243243|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
243244|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
243245|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
243246|NCT01238900|O1|Outcome|Per- Protocol Analysis of Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
243248|NCT01238900|E1|Reported Event|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
243249|NCT01238861|B7|Baseline|Total|Total of all reporting groups
243250|NCT01238861|B6|Baseline|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243251|NCT01238861|B5|Baseline|Non-eosinophil Phenotype (EOS-) Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243252|NCT01238861|B4|Baseline|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243253|NCT01238861|B3|Baseline|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243254|NCT01238861|B2|Baseline|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243255|NCT01238861|B1|Baseline|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243256|NCT01238861|P6|Participant Flow|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243257|NCT01238861|P5|Participant Flow|Non-eosinophil Phenotype (EOS-) Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243258|NCT01238861|P4|Participant Flow|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243259|NCT01238861|P3|Participant Flow|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243260|NCT01238861|P2|Participant Flow|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243261|NCT01238861|P1|Participant Flow|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243262|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243263|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243264|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243265|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
243266|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243267|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243268|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243269|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
243270|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243271|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243272|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243273|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
243274|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243275|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243276|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243277|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
243278|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243279|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243280|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243281|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
243282|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243283|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243284|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243285|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
243286|NCT01238861|O6|Outcome|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243287|NCT01238861|O5|Outcome|EOS- Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243288|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243289|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243290|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243291|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
243292|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243293|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243294|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243295|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
243296|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243297|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243298|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243299|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
243300|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243301|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243302|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243303|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
243304|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243305|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243306|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243307|NCT01238861|O1|Outcome|Placebo|EOS+ and EOS- participants received two placebo injections subcutaneously.
243308|NCT01238861|O6|Outcome|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243309|NCT01238861|O5|Outcome|EOS- Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243310|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243311|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243312|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243313|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
243314|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243315|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243316|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243317|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
243318|NCT01238861|O3|Outcome|Benralizumab, 100 mg|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
243319|NCT01238861|O2|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243320|NCT01238861|O1|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243322|NCT01238861|O2|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243323|NCT01238861|O1|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243324|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243325|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243326|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243327|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
243328|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243329|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243330|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243331|NCT01238861|O1|Outcome|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
243332|NCT01238861|E6|Reported Event|EOS NEG Benralizumab 100 mg|EOS- participants received two benralizumab 50 mg injections subcutaneously.
243333|NCT01238861|E5|Reported Event|EOS NEG Placebo|EOS- participants received two placebo injections subcutaneously.
243334|NCT01238861|E4|Reported Event|EOS POS Benralizumab 100 mg|EOS+ participants received two benralizumab 50 mg injections subcutaneously.
243335|NCT01238861|E3|Reported Event|EOS POS Benralizumab 20 mg|EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
243336|NCT01238861|E2|Reported Event|EOS POS Benralizumab 2 mg|EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
243337|NCT01238861|E1|Reported Event|EOS POS Placebo|EOS+ participants received two placebo injections subcutaneously.
243338|NCT01238848|B3|Baseline|Total|Total of all reporting groups
243339|NCT01238848|B2|Baseline|Normal|Normal saline (sodium chloride 0.9%) + albuterol
243340|NCT01238848|B1|Baseline|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
243341|NCT01238848|P2|Participant Flow|Normal|Normal saline (sodium chloride 0.9%) + albuterol
243342|NCT01238848|P1|Participant Flow|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
243343|NCT01238848|O2|Outcome|Normal|Normal saline (sodium chloride 0.9%) + albuterol
243344|NCT01238848|O1|Outcome|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
243345|NCT01238848|O2|Outcome|Normal|Normal saline (sodium chloride 0.9%) + albuterol
243346|NCT01238848|O1|Outcome|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
243347|NCT01238848|E2|Reported Event|Normal|Normal saline (sodium chloride 0.9%) + albuterol
243348|NCT01238848|E1|Reported Event|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
243349|NCT01238822|B1|Baseline|All Participants|All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
243350|NCT01238822|P1|Participant Flow|All Participants|All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
243351|NCT01238822|O4|Outcome|High Dosage|54 mg methylphenidate if >25 kg; 36 mg methylphenidate if < 25 kg.
243352|NCT01238822|O3|Outcome|Medium Dosage|36 mg methylphenidate if >25 kg; 27 mg methylphenidate if < 25 kg.
243353|NCT01238822|O2|Outcome|Low Dosage|18 mg methylphenidate
243354|NCT01238822|O1|Outcome|Placebo|placebo
243355|NCT01238822|E4|Reported Event|High Dosage|54 mg methylphenidate
243356|NCT01238822|E3|Reported Event|Medium Dosage|Medium Dosage: 36 mg methylphenidate
243357|NCT01238822|E2|Reported Event|Low Dosage|Low dose: 18 mg methylphenidate
243358|NCT01238822|E1|Reported Event|Placebo|
243359|NCT01238640|B1|Baseline|Overall Study|
243360|NCT01238640|P1|Participant Flow|Overall Study|
243361|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
243362|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
243363|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
243364|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
243365|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
243366|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
243367|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
243368|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
243369|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
243372|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
243373|NCT01238640|E3|Reported Event|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
243374|NCT01238640|E2|Reported Event|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
243375|NCT01238640|E1|Reported Event|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
243376|NCT01238588|B1|Baseline|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
243377|NCT01238588|P1|Participant Flow|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
243378|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
243379|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
243380|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
243381|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
243382|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
243383|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
243384|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
243385|NCT01238588|O1|Outcome|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
243386|NCT01238588|E1|Reported Event|Sevelamer Carbonate (Renvela)|"Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines."
243387|NCT01238575|B3|Baseline|Total|Total of all reporting groups
243388|NCT01238575|B2|Baseline|Inactive Placebo|placebo: Administered for up to 8 weeks.
243389|NCT01238575|B1|Baseline|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243390|NCT01238575|P2|Participant Flow|Inactive Placebo|placebo: Administered for up to 8 weeks.
243391|NCT01238575|P1|Participant Flow|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243392|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243393|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243394|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243395|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243396|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243397|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243398|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243399|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243400|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243401|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243402|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
289087|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
243403|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243404|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243405|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243406|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243407|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243408|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243409|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243410|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243411|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243412|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243413|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243414|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243415|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243416|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243417|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243418|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243419|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243420|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243421|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243422|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
243423|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243424|NCT01238575|E2|Reported Event|Inactive Placebo|placebo: Administered for up to 8 weeks.
243425|NCT01238575|E1|Reported Event|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
243426|NCT01238471|B3|Baseline|Total|Total of all reporting groups
243427|NCT01238471|B2|Baseline|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization
sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
243428|NCT01238471|B1|Baseline|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization
propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
243429|NCT01238471|P2|Participant Flow|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization
sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
243430|NCT01238471|P1|Participant Flow|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization
propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
243431|NCT01238471|O2|Outcome|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization
sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
243432|NCT01238471|O1|Outcome|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization
propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
243433|NCT01238471|E2|Reported Event|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization
sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
243434|NCT01238471|E1|Reported Event|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization
propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
243435|NCT01238341|B1|Baseline|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
243436|NCT01238341|P1|Participant Flow|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
243437|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
243438|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
243439|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
243440|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
243441|NCT01238341|E1|Reported Event|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
243463|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243464|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243442|NCT01238211|B1|Baseline|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
243443|NCT01238211|P1|Participant Flow|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
243444|NCT01238211|O1|Outcome|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
243445|NCT01238211|E1|Reported Event|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
243446|NCT01237613|B1|Baseline|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243447|NCT01237613|P1|Participant Flow|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243448|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243449|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243450|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243451|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243452|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patientschronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243453|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243454|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243455|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243456|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243457|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243458|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243459|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243460|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243461|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243462|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243465|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243466|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243467|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243468|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243469|NCT01237613|E1|Reported Event|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement"
243470|NCT01237353|B1|Baseline|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5
Rabeprazole : rabeprazole po daily x 5 days"
243471|NCT01237353|P1|Participant Flow|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5
Rabeprazole : rabeprazole po daily x 5 days"
243472|NCT01237353|O1|Outcome|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5
Rabeprazole : rabeprazole po daily x 5 days"
243473|NCT01237353|O1|Outcome|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5
Rabeprazole : rabeprazole po daily x 5 days"
243474|NCT01237353|E1|Reported Event|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5
Rabeprazole : rabeprazole po daily x 5 days"
243475|NCT01237340|B1|Baseline|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243476|NCT01237340|P1|Participant Flow|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243477|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243478|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243479|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243480|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243481|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243482|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243483|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243484|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243485|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243486|NCT01237340|E1|Reported Event|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
243491|NCT01237327|P1|Participant Flow|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
243492|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
243493|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
243494|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
243495|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
243496|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
243497|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
243498|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
243499|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
243500|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
243501|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
243502|NCT01237327|E2|Reported Event|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
243503|NCT01237327|E1|Reported Event|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
243504|NCT01237301|B3|Baseline|Total|Total of all reporting groups
243505|NCT01237301|B2|Baseline|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.
Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
243506|NCT01237301|B1|Baseline|CGM Group|"Wear an unblinded CGM for 16 weeks.
Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
243507|NCT01237301|P2|Participant Flow|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.
Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
243508|NCT01237301|P1|Participant Flow|CGM Group|"Wear an unblinded CGM for 16 weeks.
Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
243509|NCT01237301|O2|Outcome|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.
Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
243510|NCT01237301|O1|Outcome|CGM Group|"Wear an unblinded CGM for 16 weeks.
Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
243511|NCT01237301|E2|Reported Event|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.
Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
243512|NCT01237301|E1|Reported Event|CGM Group|"Wear an unblinded CGM for 16 weeks.
Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
243513|NCT01237223|B7|Baseline|Total|Total of all reporting groups
243514|NCT01237223|B6|Baseline|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243515|NCT01237223|B5|Baseline|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
243516|NCT01237223|B4|Baseline|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243517|NCT01237223|B3|Baseline|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243518|NCT01237223|B2|Baseline|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243519|NCT01237223|B1|Baseline|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
243520|NCT01237223|P6|Participant Flow|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243521|NCT01237223|P5|Participant Flow|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
243683|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
243522|NCT01237223|P4|Participant Flow|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243523|NCT01237223|P3|Participant Flow|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243524|NCT01237223|P2|Participant Flow|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243525|NCT01237223|P1|Participant Flow|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
243526|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243527|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
243528|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243529|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243530|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243531|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
243532|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243533|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
243534|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243535|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243536|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243537|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
243538|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243768|NCT01236170|B1|Baseline|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
243539|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
243540|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243541|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243542|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243543|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
243544|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243545|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
243546|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243547|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243548|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243549|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
243550|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243551|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
243552|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243553|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243554|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243555|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind treatment period.
243734|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
243556|NCT01237223|E7|Reported Event|Placebo (Single-Blind run-in Period)|In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in period (4 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
243557|NCT01237223|E6|Reported Event|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243558|NCT01237223|E5|Reported Event|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
243559|NCT01237223|E4|Reported Event|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
243560|NCT01237223|E3|Reported Event|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243561|NCT01237223|E2|Reported Event|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
243562|NCT01237223|E1|Reported Event|Placebo (Double Blind)|In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
243563|NCT01237197|B3|Baseline|Total|Total of all reporting groups
243564|NCT01237197|B2|Baseline|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.
Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
243565|NCT01237197|B1|Baseline|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)
Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
243566|NCT01237197|P2|Participant Flow|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.
Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
243567|NCT01237197|P1|Participant Flow|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)
Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
243568|NCT01237197|O2|Outcome|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.
Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
243569|NCT01237197|O1|Outcome|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)
Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
243570|NCT01237197|E2|Reported Event|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.
Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
243571|NCT01237197|E1|Reported Event|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)
Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
243572|NCT01237080|B3|Baseline|Total|Total of all reporting groups
243573|NCT01237080|B2|Baseline|GlideScope|50 persons beeing intubated using the GlideScope.
243574|NCT01237080|B1|Baseline|Fastrach|50 persons beeing intubated using the Fastrach.
243575|NCT01237080|P2|Participant Flow|GlideScope|50 persons beeing intubated using the GlideScope.
243576|NCT01237080|P1|Participant Flow|Fastrach|50 persons beeing intubated using the Fastrach.
243577|NCT01237080|O2|Outcome|GlideScope|50 persons beeing intubated using the GlideScope.
243578|NCT01237080|O1|Outcome|Fastrach|50 persons beeing intubated using the Fastrach.
243579|NCT01237080|O2|Outcome|GlideScope|50 persons beeing intubated using the GlideScope.
243580|NCT01237080|O1|Outcome|Fastrach|50 persons beeing intubated using the Fastrach.
243581|NCT01237080|E2|Reported Event|GlideScope|50 persons beeing intubated using the GlideScope.
243582|NCT01237080|E1|Reported Event|Fastrach|50 persons beeing intubated using the Fastrach.
243735|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
243583|NCT01237054|B1|Baseline|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).
18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
243584|NCT01237054|P1|Participant Flow|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).
18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
243585|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder. Multiple myeloma is a plasma cell neoplasm.
243586|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
243587|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder. Multiple myeloma is a plasma cell neoplasm.
243588|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
243589|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
243590|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
243591|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
243592|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
243593|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
243594|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
243595|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder. Multiple myeloma is a plasma cell neoplasm.
243596|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
243597|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
243598|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
243599|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
243600|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
243601|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
243602|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
243603|NCT01237054|E1|Reported Event|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).
18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
243604|NCT01236573|B12|Baseline|Total|Total of all reporting groups
243605|NCT01236573|B11|Baseline|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243684|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
243736|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
243606|NCT01236573|B10|Baseline|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243607|NCT01236573|B9|Baseline|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243608|NCT01236573|B8|Baseline|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243609|NCT01236573|B7|Baseline|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243610|NCT01236573|B6|Baseline|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243611|NCT01236573|B5|Baseline|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243612|NCT01236573|B4|Baseline|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243613|NCT01236573|B3|Baseline|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243614|NCT01236573|B2|Baseline|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243615|NCT01236573|B1|Baseline|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243616|NCT01236573|P11|Participant Flow|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243617|NCT01236573|P10|Participant Flow|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243728|NCT01236326|B3|Baseline|Total|Total of all reporting groups
243729|NCT01236326|B2|Baseline|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
243618|NCT01236573|P9|Participant Flow|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243619|NCT01236573|P8|Participant Flow|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243620|NCT01236573|P7|Participant Flow|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243621|NCT01236573|P6|Participant Flow|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243622|NCT01236573|P5|Participant Flow|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243623|NCT01236573|P4|Participant Flow|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243624|NCT01236573|P3|Participant Flow|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243625|NCT01236573|P2|Participant Flow|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243626|NCT01236573|P1|Participant Flow|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243627|NCT01236573|O11|Outcome|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243628|NCT01236573|O10|Outcome|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243629|NCT01236573|O9|Outcome|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243730|NCT01236326|B1|Baseline|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
243630|NCT01236573|O8|Outcome|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243631|NCT01236573|O7|Outcome|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243632|NCT01236573|O6|Outcome|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243633|NCT01236573|O5|Outcome|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243634|NCT01236573|O4|Outcome|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243635|NCT01236573|O3|Outcome|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243636|NCT01236573|O2|Outcome|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243637|NCT01236573|O1|Outcome|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243638|NCT01236573|O11|Outcome|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243639|NCT01236573|O10|Outcome|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243640|NCT01236573|O9|Outcome|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243641|NCT01236573|O8|Outcome|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243731|NCT01236326|P2|Participant Flow|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
289088|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
243642|NCT01236573|O7|Outcome|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243643|NCT01236573|O6|Outcome|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243644|NCT01236573|O5|Outcome|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243645|NCT01236573|O4|Outcome|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243646|NCT01236573|O3|Outcome|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243647|NCT01236573|O2|Outcome|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243648|NCT01236573|O1|Outcome|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243649|NCT01236573|O1|Outcome|All Phase I Participants|All phase I participants who received at least one dose intravenously of CD8 + TIL expressing IL-12 in Groups 1-4, and Bulk TIL expressing IL-12 in Groups 5-10 (i.e., CD8 + TIL expressing IL-12 1x10^6, CD8 + TIL expressing IL-12 3x10^6, CD8 + TIL expressing IL-12 3x10^7, CD8 + TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^7, Bulk TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^8, Bulk TIL expressing IL-12 3x10^8, Bulk TIL expressing IL-12 1x10^9, and Bulk TIL expressing IL-12 3x10^9) respectively.
243650|NCT01236573|E11|Reported Event|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243651|NCT01236573|E10|Reported Event|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243652|NCT01236573|E9|Reported Event|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243653|NCT01236573|E8|Reported Event|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243732|NCT01236326|P1|Participant Flow|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
246030|NCT01229371|P2|Participant Flow|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
243654|NCT01236573|E7|Reported Event|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243655|NCT01236573|E6|Reported Event|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243656|NCT01236573|E5|Reported Event|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243657|NCT01236573|E4|Reported Event|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243658|NCT01236573|E3|Reported Event|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243659|NCT01236573|E2|Reported Event|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243660|NCT01236573|E1|Reported Event|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
243661|NCT01236534|B3|Baseline|Total|Total of all reporting groups
243662|NCT01236534|B2|Baseline|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
243663|NCT01236534|B1|Baseline|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
243664|NCT01236534|P2|Participant Flow|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
243665|NCT01236534|P1|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
243666|NCT01236534|O2|Outcome|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
243667|NCT01236534|O1|Outcome|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
243668|NCT01236534|O2|Outcome|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
243669|NCT01236534|O1|Outcome|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
243670|NCT01236534|E2|Reported Event|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
243671|NCT01236534|E1|Reported Event|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
243672|NCT01236391|B1|Baseline|PCI-32765|PCI-32765: 560 mg daily
243673|NCT01236391|P1|Participant Flow|PCI-32765|Participants received 560 mg daily
243674|NCT01236391|O1|Outcome|EORTC QLQ-C30|Participants received PCI-32765 560 mg daily and completed the EORTC QLQ-C30 questionnaire at Pre-Dose and at Cycle 5
243675|NCT01236391|O2|Outcome|PCI-45227 (Metabolite)- Day 8|PCI-32765: 560 mg daily
243676|NCT01236391|O1|Outcome|PCI-32765 - Day 8|PCI-32765: 560 mg daily
243677|NCT01236391|O1|Outcome|PCI-32765|PCI-32765: 560 mg daily
243678|NCT01236391|O1|Outcome|PCI-32765|PCI-32765: 560 mg daily
243679|NCT01236391|E1|Reported Event|PCI-32765|PCI-32765: 560 mg daily
243680|NCT01236378|B1|Baseline|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
243681|NCT01236378|P1|Participant Flow|Sirolimus|Sirolimus, 1 milligram (mg) tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last pharmacokinetic (PK) sample collection.
243682|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
243733|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
243685|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
243686|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
243687|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
243688|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
243689|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
243690|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
243691|NCT01236378|E1|Reported Event|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
243692|NCT01236365|B3|Baseline|Total|Total of all reporting groups
243693|NCT01236365|B2|Baseline|Placebo|Atorvastatin Placebo: 10 or 20 mg daily
243694|NCT01236365|B1|Baseline|Atorvastatin|Atorvastatin: 10 or 20 mg daily
243695|NCT01236365|P2|Participant Flow|Placebo|Placebo: 10 or 20 mg daily
243696|NCT01236365|P1|Participant Flow|Atorvastatin|Atorvastatin: 10 or 20 mg daily
243697|NCT01236365|O4|Outcome|Placebo hsCRP at 6 Months|
243698|NCT01236365|O3|Outcome|Placebo hsCRP at Randomization|
243699|NCT01236365|O2|Outcome|Atorvastatin hsCRP at 6 Months|
243700|NCT01236365|O1|Outcome|Atorvastatin hsCRP at Randomization|
243701|NCT01236365|O4|Outcome|Placebo LDL-C at 6 Months|
243702|NCT01236365|O3|Outcome|Placebo LDL-C at Randomization|
243703|NCT01236365|O2|Outcome|Atorvastatin LDL-C at 6 Months|
243704|NCT01236365|O1|Outcome|Atorvastatin LDL-C at Randomization|
243705|NCT01236365|E2|Reported Event|Placebo|Atorvastatin Placebo: 10 or 20 mg daily
243706|NCT01236365|E1|Reported Event|Atorvastatin|Atorvastatin: 10 or 20 mg daily
243707|NCT01236339|B3|Baseline|Total|Total of all reporting groups
243708|NCT01236339|B2|Baseline|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis
*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)."
243709|NCT01236339|B1|Baseline|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >
> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
243710|NCT01236339|P2|Participant Flow|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis
*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)"
243711|NCT01236339|P1|Participant Flow|TIPS|TIPS with GORE® VIATORR® TIPS Endoprosthesis
243712|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
243713|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >
> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
243714|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
243715|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >
> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
243716|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
243717|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >
> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
243718|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
243719|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >
> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
243720|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
243721|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >
> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
243722|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
243723|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >
> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
243724|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
243725|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >
> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
243726|NCT01236339|E2|Reported Event|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis
*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)."
243727|NCT01236339|E1|Reported Event|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >
> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
243737|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
243738|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
243739|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
243740|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
243741|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
243742|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
243743|NCT01236326|E2|Reported Event|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
243744|NCT01236326|E1|Reported Event|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
243745|NCT01236300|B1|Baseline|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
243746|NCT01236300|P1|Participant Flow|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
243747|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
243748|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
243749|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
243750|NCT01236300|O1|Outcome|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
243751|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
243752|NCT01236300|E1|Reported Event|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
243753|NCT01236196|B3|Baseline|Total|Total of all reporting groups
243754|NCT01236196|B2|Baseline|Arm 2 - Telephone Education|"Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
243755|NCT01236196|B1|Baseline|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
243756|NCT01236196|P2|Participant Flow|Arm 2 - Telephone Education|"Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
243757|NCT01236196|P1|Participant Flow|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
243758|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
243759|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
243760|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
243761|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
243762|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
243763|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
243764|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
243765|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
243766|NCT01236196|E2|Reported Event|Arm 2 - Telephone Education|"Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
243767|NCT01236196|E1|Reported Event|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
243769|NCT01236170|P1|Participant Flow|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
243770|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
243771|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
243772|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
243773|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
243774|NCT01236170|E1|Reported Event|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
243775|NCT01236118|B4|Baseline|Total|Total of all reporting groups
243776|NCT01236118|B3|Baseline|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 Q2W subcutaneous injection for the first 3 doses then Q4W until Week 44.
243777|NCT01236118|B2|Baseline|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and then Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
243778|NCT01236118|B1|Baseline|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
243779|NCT01236118|P3|Participant Flow|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
243780|NCT01236118|P2|Participant Flow|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
243781|NCT01236118|P1|Participant Flow|30 mg LY2439821|Included participants from 30 milligrams (mg) group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection once every week (Q1W) for the first 3 doses and once every 2 weeks (Q2W) until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection once every 4 weeks (Q4W) until Week 44.
243782|NCT01236118|O3|Outcome|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
243783|NCT01236118|O2|Outcome|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
243784|NCT01236118|O1|Outcome|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
243785|NCT01236118|E3|Reported Event|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
243786|NCT01236118|E2|Reported Event|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
243787|NCT01236118|E1|Reported Event|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
243788|NCT01236105|B1|Baseline|LY2624803|"Participants received each of the following 3 study treatments:
LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.
LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast."
243789|NCT01236105|P1|Participant Flow|LY2624803|"Participants received each of the following 3 study treatments:
LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.
LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast."
243790|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
243791|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
243792|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
243793|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
243794|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
243795|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
243796|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
243797|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
243798|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
243799|NCT01236105|E3|Reported Event|LY2624803 Evening Dosing|LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast.
243800|NCT01236105|E2|Reported Event|LY2624803 Morning Dosing + Activated Charcoal|LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
243801|NCT01236105|E1|Reported Event|LY2624803 Morning Dosing|LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.
243802|NCT01236053|B23|Baseline|Total|Total of all reporting groups
243803|NCT01236053|B22|Baseline|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243804|NCT01236053|B21|Baseline|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243805|NCT01236053|B20|Baseline|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243806|NCT01236053|B19|Baseline|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243807|NCT01236053|B18|Baseline|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243808|NCT01236053|B17|Baseline|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243809|NCT01236053|B16|Baseline|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243852|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
243918|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
246031|NCT01229371|P1|Participant Flow|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
243810|NCT01236053|B15|Baseline|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243811|NCT01236053|B14|Baseline|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243812|NCT01236053|B13|Baseline|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243813|NCT01236053|B12|Baseline|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243814|NCT01236053|B11|Baseline|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243815|NCT01236053|B10|Baseline|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243816|NCT01236053|B9|Baseline|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243817|NCT01236053|B8|Baseline|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243818|NCT01236053|B7|Baseline|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243819|NCT01236053|B6|Baseline|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243820|NCT01236053|B5|Baseline|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243821|NCT01236053|B4|Baseline|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243822|NCT01236053|B3|Baseline|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243884|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
243823|NCT01236053|B2|Baseline|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243824|NCT01236053|B1|Baseline|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243825|NCT01236053|P22|Participant Flow|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243826|NCT01236053|P21|Participant Flow|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243827|NCT01236053|P20|Participant Flow|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243828|NCT01236053|P19|Participant Flow|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243829|NCT01236053|P18|Participant Flow|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243830|NCT01236053|P17|Participant Flow|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243831|NCT01236053|P16|Participant Flow|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243832|NCT01236053|P15|Participant Flow|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243833|NCT01236053|P14|Participant Flow|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243834|NCT01236053|P13|Participant Flow|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243835|NCT01236053|P12|Participant Flow|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243836|NCT01236053|P11|Participant Flow|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243837|NCT01236053|P10|Participant Flow|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243838|NCT01236053|P9|Participant Flow|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243839|NCT01236053|P8|Participant Flow|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243840|NCT01236053|P7|Participant Flow|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243841|NCT01236053|P6|Participant Flow|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243842|NCT01236053|P5|Participant Flow|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243843|NCT01236053|P4|Participant Flow|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243844|NCT01236053|P3|Participant Flow|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243845|NCT01236053|P2|Participant Flow|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243846|NCT01236053|P1|Participant Flow|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243847|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243848|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
243849|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243850|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
243851|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243853|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243854|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
243855|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243856|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
243857|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243858|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
243859|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243860|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
243861|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243862|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
243863|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243864|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
243865|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243866|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
243867|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243868|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
243869|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243870|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
243871|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243872|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
243873|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243874|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
243875|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243876|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
243877|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243878|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
243879|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243880|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
243881|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243882|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
243883|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243885|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243886|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
243887|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243888|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
243889|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243890|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
243891|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243892|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
243893|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243894|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
243895|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243896|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
243897|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243898|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
243899|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243900|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
243901|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243902|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
243903|NCT01236053|O2|Outcome|Controls|Controls
243904|NCT01236053|O1|Outcome|Cases|Cases
243905|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243906|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
243907|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243908|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
243909|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243910|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
243911|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243912|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
243913|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243914|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
243915|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243916|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
243917|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice
243919|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243920|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
243921|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243922|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
243923|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243924|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
243925|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243926|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
243927|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243928|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
243929|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243930|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
243931|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243932|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
243933|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243934|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
243935|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243936|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
243937|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243938|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
243939|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243940|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
243941|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243942|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
243943|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243944|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
243945|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243946|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
243947|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243948|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
243949|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243950|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
244664|NCT01232569|B2|Baseline|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
243951|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243952|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
243953|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243954|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
243955|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
243956|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
243957|NCT01236053|E22|Reported Event|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243958|NCT01236053|E21|Reported Event|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243959|NCT01236053|E20|Reported Event|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243960|NCT01236053|E19|Reported Event|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243961|NCT01236053|E18|Reported Event|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243962|NCT01236053|E17|Reported Event|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243963|NCT01236053|E16|Reported Event|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243964|NCT01236053|E15|Reported Event|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243965|NCT01236053|E14|Reported Event|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243966|NCT01236053|E13|Reported Event|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243983|NCT01236001|P1|Participant Flow|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
243984|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
243967|NCT01236053|E12|Reported Event|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243968|NCT01236053|E11|Reported Event|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243969|NCT01236053|E10|Reported Event|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243970|NCT01236053|E9|Reported Event|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243971|NCT01236053|E8|Reported Event|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243972|NCT01236053|E7|Reported Event|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243973|NCT01236053|E6|Reported Event|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243974|NCT01236053|E5|Reported Event|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243975|NCT01236053|E4|Reported Event|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243976|NCT01236053|E3|Reported Event|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243977|NCT01236053|E2|Reported Event|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
243978|NCT01236053|E1|Reported Event|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
243979|NCT01236001|B3|Baseline|Total|Total of all reporting groups
243980|NCT01236001|B2|Baseline|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
243981|NCT01236001|B1|Baseline|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
243982|NCT01236001|P2|Participant Flow|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
246032|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
243985|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
243986|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
243987|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
243988|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
243989|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
243990|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
243991|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
243992|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
243993|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
243994|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
243995|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
243996|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
243997|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
243998|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
243999|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
244000|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
244001|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
244002|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
244003|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
244004|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
244005|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
244006|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
244007|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
244008|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
244009|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
244010|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
244011|NCT01236001|E1|Reported Event|Vimpat® Treatment|Reported Adverse Events is a combination of both patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
244012|NCT01235975|B3|Baseline|Total|Total of all reporting groups
244013|NCT01235975|B2|Baseline|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244014|NCT01235975|B1|Baseline|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244015|NCT01235975|P2|Participant Flow|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244016|NCT01235975|P1|Participant Flow|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244017|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244018|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244019|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244020|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244021|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244022|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244023|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
246033|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
244024|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244025|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244026|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244027|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244028|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244029|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244030|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244031|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244032|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244033|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244034|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244035|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244036|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244037|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244038|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244039|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244040|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244041|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244042|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244043|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244044|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244045|NCT01235975|E2|Reported Event|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
244046|NCT01235975|E1|Reported Event|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
244047|NCT01235923|B3|Baseline|Total|Total of all reporting groups
244048|NCT01235923|B2|Baseline|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
244049|NCT01235923|B1|Baseline|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
244050|NCT01235923|P2|Participant Flow|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
244051|NCT01235923|P1|Participant Flow|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
244052|NCT01235923|O2|Outcome|Three Times a Week Epo|
244053|NCT01235923|O1|Outcome|Weekly Epo|
244054|NCT01235923|O2|Outcome|Three Times a Week Epo|
244055|NCT01235923|O1|Outcome|Weekly Epo|
244056|NCT01235923|E2|Reported Event|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
244057|NCT01235923|E1|Reported Event|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
244058|NCT01235910|B1|Baseline|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
244096|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
244059|NCT01235910|P1|Participant Flow|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
244060|NCT01235910|O1|Outcome|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
244061|NCT01235910|E1|Reported Event|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
244062|NCT01235897|B1|Baseline|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
244063|NCT01235897|P1|Participant Flow|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
244064|NCT01235897|O1|Outcome|MK-2206|MK-2206 given orally at a dose of 135 mg weekly + Trastuzumab 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg + Paclitaxel 80 mg/m2 weekly
244065|NCT01235897|O1|Outcome|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
244066|NCT01235897|E1|Reported Event|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
244067|NCT01235741|B4|Baseline|Total|Total of all reporting groups
244068|NCT01235741|B3|Baseline|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244069|NCT01235741|B2|Baseline|Placebo|Self administered subcutaneous (SC ) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks.
244070|NCT01235741|B1|Baseline|Non-Randomized Lead-in LCD|6 Week Lead-in with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to study drug in the Randomization period.
244071|NCT01235741|P3|Participant Flow|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 micrograms (µg) + metreleptin 5.0 milligrams (mg) BID for 16 weeks
244072|NCT01235741|P2|Participant Flow|Placebo|Self administered subcutaneous (SC) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks.
244073|NCT01235741|P1|Participant Flow|Low Calorie Diet Only|6 Week Lead-in Period with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to either study drug or placebo in the Randomization period.
244074|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244075|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
244076|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244077|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks
244078|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244079|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks
244080|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244081|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
244082|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244083|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
244084|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244085|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
244086|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244087|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
244088|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244089|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244090|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244091|NCT01235741|O4|Outcome|Post Treatment Pramlintide + Metreleptin Arm|From date after the date of last dose (imputed if not available) of randomized study medication up to 6 Months post treatment.
244092|NCT01235741|O3|Outcome|Post Treatment Placebo Arm|From date after the date of last dose (imputed if not available) of randomized study medication up to 6 Months post treatment.
244093|NCT01235741|O2|Outcome|On Treatment Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244094|NCT01235741|O1|Outcome|On Treatment Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
244095|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
244097|NCT01235741|E2|Reported Event|Pramlintide + Metreleptin|Self administered subcutaneous injection once a day (QD) of pramlintide 360 micrograms (µg) plus metreleptin 5.0 milligrams (mg ) for 1 week followed by twice a week (BID) dosing for 15 weeks (Total of 16 Weeks treatment).
244098|NCT01235741|E1|Reported Event|Placebo-P + Placebo-M|Self administered subcutaneous injection once a day (QD) of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) for 1 week followed by BID dosing for 15 weeks (16 weeks total).
244099|NCT01235728|B1|Baseline|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
244100|NCT01235728|P8|Participant Flow|Treatment Sequence 8|Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and calcitriol on upper lesion C and MK-0873 on upper lesion D.
244101|NCT01235728|P7|Participant Flow|Treatment Sequence 7|Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
244102|NCT01235728|P6|Participant Flow|Treatment Sequence 6|Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
244103|NCT01235728|P5|Participant Flow|Treatment Sequence 5|Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
244104|NCT01235728|P4|Participant Flow|Treatment Sequence 4|Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and calcitriol on upper lesion C and MK-873 on upper lesion D.
244105|NCT01235728|P3|Participant Flow|Treatment Sequence 3|Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
244106|NCT01235728|P2|Participant Flow|Treatment Sequence 2|Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
244107|NCT01235728|P1|Participant Flow|Treatment Sequence 1|Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
244108|NCT01235728|O1|Outcome|MK-0873|Participants were randomized to receive MK- 0873 on upper or lower lesion A or B and MK-0873 Vehicle on the opposing lesion B or A, and MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C.
244109|NCT01235728|O2|Outcome|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
244110|NCT01235728|O1|Outcome|Calcitriol 0.0003%|Participants were randomly assigned to receive calcitriol 0.0003% (3mg/g) BID for 28 days on upper or lower lesion C or D and MK-0873 on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
244111|NCT01235728|O2|Outcome|MK-0873 Vehicle|Participants were randomized to receive MK-0873 vehicle on upper or lower lesion A or B and MK-0873 on the opposing lesion B or A. The lesion receiving MK-0873 vehicle was evaluated.
244112|NCT01235728|O1|Outcome|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
244113|NCT01235728|E1|Reported Event|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
244114|NCT01235715|B3|Baseline|Total|Total of all reporting groups
244115|NCT01235715|B2|Baseline|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244116|NCT01235715|B1|Baseline|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244117|NCT01235715|P2|Participant Flow|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244118|NCT01235715|P1|Participant Flow|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244119|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244120|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244121|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244122|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244123|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244124|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244125|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244183|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
246034|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
244126|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244127|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244128|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244129|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244130|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244131|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244132|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244133|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244134|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244135|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244136|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244137|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244138|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244139|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244140|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244141|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244142|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244143|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244144|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244145|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244146|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244147|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244148|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244149|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244150|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244151|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
246035|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
244152|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244153|NCT01235715|E2|Reported Event|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
244154|NCT01235715|E1|Reported Event|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
244155|NCT01235598|B3|Baseline|Total|Total of all reporting groups
244156|NCT01235598|B2|Baseline|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244157|NCT01235598|B1|Baseline|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244158|NCT01235598|P2|Participant Flow|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244159|NCT01235598|P1|Participant Flow|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244160|NCT01235598|O2|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244161|NCT01235598|O1|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244162|NCT01235598|O2|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244163|NCT01235598|O1|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244164|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244165|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244166|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244167|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244168|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244169|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244170|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244171|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244172|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244173|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244174|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244175|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244176|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244177|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244178|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244179|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244180|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244181|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244182|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
246036|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
244184|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244185|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244186|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244187|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244188|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244189|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244190|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
244191|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244192|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244193|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244194|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244195|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244196|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244197|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244198|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244199|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
244200|NCT01235598|E1|Reported Event|Certolizumab Pegol (CZP) at Any Time|"Eligible subjects were allocated to the following study treatments in a 2:1 ratio:
Certolizumab Pegol (CZP) 400mg for subcutaneous injection (sc) at Weeks 0, 2, and 4, followed by CZP 200mg sc and placebo (saline solution) at Week 6 and CZP 200mg at Weeks 8, 10, 12, 14, and 16 or
Placebo (saline solution) at Day 0 and then CZP 400mg sc at Weeks 2, 4, and 6 followed by CZP 200mg sc at Weeks 8, 10, 12, 14, and 16"
244201|NCT01235546|B3|Baseline|Total|Total of all reporting groups
244202|NCT01235546|B2|Baseline|Azithromycin (Zithromax) With Standard Prophylaxis|Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis
244203|NCT01235546|B1|Baseline|Placebo With Standard Prophylaxis|Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis
244204|NCT01235546|P2|Participant Flow|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and standard of care (cephazolin or clindamycin)
244205|NCT01235546|P1|Participant Flow|Placebo and Standard of Care|Placebo: 250 cc normal saline Standard of care (cephazolin or clindamycin)
244206|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
244207|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
244208|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
244209|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
244210|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
244211|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
244212|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
244213|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
244214|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard of care (cefazolin or clindamycin)
244215|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline Standard of care (cefazolin or clindamycin)
244216|NCT01235546|O2|Outcome|Azithromycin (Zithromax) With Standard Prophylaxis|Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis
244217|NCT01235546|O1|Outcome|Placebo With Standard Prophylaxis|Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis
244218|NCT01235546|O2|Outcome|Azithromycin (Zithromax) With Standard Prophylaxis|Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis
244219|NCT01235546|O1|Outcome|Placebo With Standard Prophylaxis|Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis
244220|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
246037|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
244221|NCT01235546|O1|Outcome|Placebo and Standard of Care|"250 cc normal saline
Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)"
244222|NCT01235546|O2|Outcome|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of Care (cefazolin or clindamycin
244223|NCT01235546|O1|Outcome|Placebo and Standard of Care|Placebo: 250 cc normal saline and standard of care (cefazolin or clindamycin)
244224|NCT01235546|O2|Outcome|Azithromycin|Azithromycin: 500 mg in 250 cc normal saline 1 time dose
244225|NCT01235546|O1|Outcome|Placebo|"250 cc normal saline
Placebo: 250 cc normal saline"
244226|NCT01235546|E2|Reported Event|Azithromycin and Standard of Care|Azithromycin: 500 mg in 250 cc normal saline and Standard of care (cefazolin or clindamycin)
244227|NCT01235546|E1|Reported Event|Placebo and Standard of Care|Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
244228|NCT01235507|B1|Baseline|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244229|NCT01235507|P1|Participant Flow|Tocilizumab Plus Methotrexate (MTX)|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (maximum 800 mg) intravenously (IV) every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg per week (mg/week) of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244230|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244231|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244232|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244233|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244234|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244235|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244236|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244237|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244238|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244239|NCT01235507|E1|Reported Event|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
244240|NCT01235442|B3|Baseline|Total|Total of all reporting groups
244241|NCT01235442|B2|Baseline|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
244242|NCT01235442|B1|Baseline|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
244243|NCT01235442|P2|Participant Flow|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
244244|NCT01235442|P1|Participant Flow|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
244356|NCT01234922|P4|Participant Flow|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.
losartan potassium: Given orally
laboratory biomarker analysis: Correlative studies"
244245|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
244246|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
244247|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
244248|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
244249|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
244250|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
244251|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
244252|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
244253|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
244254|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
244255|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
244256|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
244257|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
244258|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
244259|NCT01235442|E2|Reported Event|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
244260|NCT01235442|E1|Reported Event|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
244261|NCT01235403|B1|Baseline|Lacosamide|"Flexible dosing between 200mg/day and 400mg/day
Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.
Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.
Taper phase if needed: 3 to 4 weeks"
244262|NCT01235403|P1|Participant Flow|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day
Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.
Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.
Taper phase if needed: 3 to 4 weeks"
244263|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day
Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.
Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.
Taper phase if needed: 3 to 4 weeks"
244264|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day
Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.
Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.
Taper phase if needed: 3 to 4 weeks"
244265|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day
Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.
Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.
Taper phase if needed: 3 to 4 weeks"
244266|NCT01235403|E1|Reported Event|Lacosamide|"Flexible dosing between 200mg/day and 400mg/day
Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.
Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.
Taper phase if needed: 3 to 4 weeks"
244267|NCT01235377|B3|Baseline|Total|Total of all reporting groups
244357|NCT01234922|P3|Participant Flow|Arm III|"Patients receive oral ramipril twice daily on days 1-7.
laboratory biomarker analysis: Correlative studies
ramipril: Given orally"
289089|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
244268|NCT01235377|B2|Baseline|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
244269|NCT01235377|B1|Baseline|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
244270|NCT01235377|P2|Participant Flow|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
244271|NCT01235377|P1|Participant Flow|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
244272|NCT01235377|O2|Outcome|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
244273|NCT01235377|O1|Outcome|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
244274|NCT01235377|E2|Reported Event|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
244275|NCT01235377|E1|Reported Event|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
244276|NCT01235338|B3|Baseline|Total|Total of all reporting groups
244277|NCT01235338|B2|Baseline|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244278|NCT01235338|B1|Baseline|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244279|NCT01235338|P2|Participant Flow|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244280|NCT01235338|P1|Participant Flow|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244281|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244282|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244283|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244284|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244358|NCT01234922|P2|Participant Flow|Arm II|"Patients receive oral lisinopril once daily on days 1-7.
lisinopril: Given orally
laboratory biomarker analysis: Correlative studies"
244665|NCT01232569|B1|Baseline|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244285|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244286|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244287|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244288|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244289|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244290|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244291|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244292|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244293|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244294|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244295|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244296|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244297|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244298|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244359|NCT01234922|P1|Participant Flow|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.
laboratory biomarker analysis: Correlative studies
benazepril hydrochloride: Given orally"
244360|NCT01234922|O4|Outcome|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.
losartan potassium: Given orally
laboratory biomarker analysis: Correlative studies"
244299|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244300|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244301|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244302|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244303|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244304|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244305|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244306|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244307|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244308|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244309|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244310|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244311|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244312|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244361|NCT01234922|O3|Outcome|Arm III|"Patients receive oral ramipril twice daily on days 1-7.
laboratory biomarker analysis: Correlative studies
ramipril: Given orally"
244362|NCT01234922|O2|Outcome|Arm II|"Patients receive oral lisinopril once daily on days 1-7.
lisinopril: Given orally
laboratory biomarker analysis: Correlative studies"
246038|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
244313|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244314|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244315|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244316|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
244317|NCT01235338|E4|Reported Event|Venlafaxine XR Tapering|Tapering dosing period (Effexor XR 150 and 75 mg)
244318|NCT01235338|E3|Reported Event|Venlafaxine XR Titration|Titration dosing period (Effexor XR 75, 150, and 225 mg)
244319|NCT01235338|E2|Reported Event|LDX + Venlafaxine XR/Venlafaxine XR + LDX|Combination dosing periods
244320|NCT01235338|E1|Reported Event|LDX (SPD489)|Titration dosing period
244321|NCT01235234|B4|Baseline|Total|Total of all reporting groups
244322|NCT01235234|B3|Baseline|Placebo|CF101: orally q12h
244323|NCT01235234|B2|Baseline|CF101 1 mg|CF101: orally q12h
244324|NCT01235234|B1|Baseline|CF101 0.1 mg|CF101: orally q12h
244325|NCT01235234|P3|Participant Flow|Placebo|CF101: orally q12h
244326|NCT01235234|P2|Participant Flow|CF101 1 mg|CF101: orally q12h
244327|NCT01235234|P1|Participant Flow|CF101 0.1 mg|CF101: orally q12h
244328|NCT01235234|O3|Outcome|Placebo|CF101: orally q12h
244329|NCT01235234|O2|Outcome|CF101 1 mg|CF101: orally q12h
244330|NCT01235234|O1|Outcome|CF101 0.1 mg|CF101: orally q12h
244331|NCT01235234|E3|Reported Event|Placebo|CF101: orally q12h
244332|NCT01235234|E2|Reported Event|CF101 1 mg|CF101: orally q12h
244333|NCT01235234|E1|Reported Event|CF101 0.1 mg|CF101: orally q12h
244334|NCT01235195|B1|Baseline|Entire Study Population|Entire study population receiving Sertraline Hydrochloride 50 mg as either hard gelatin capsule or film-coated tablet
244335|NCT01235195|P2|Participant Flow|Sertraline 50 mg Tablet, Then Sertraline 50 mg Capsule|Sertraline Hydrochloride 50 mg film-coated tablet in the first intervention period, Sertraline Hydrochloride 50 mg hard gelatin capsule in the second intervention period
244336|NCT01235195|P1|Participant Flow|Sertraline 50 mg Capsule, Then Sertraline 50 mg Tablet|Sertraline Hydrochloride 50 milligram (mg) hard gelatin capsule in the first intervention period, Sertraline Hydrochloride 50 mg Film-Coated Tablet in the second intervention period
244337|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
244338|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
244339|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
244340|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
244341|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
244342|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
244343|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
244344|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
244345|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
244346|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
244347|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
244348|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
244349|NCT01235195|E2|Reported Event|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
244350|NCT01235195|E1|Reported Event|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
244351|NCT01234922|B5|Baseline|Total|Total of all reporting groups
244352|NCT01234922|B4|Baseline|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.
losartan potassium: Given orally
laboratory biomarker analysis: Correlative studies"
244353|NCT01234922|B3|Baseline|Arm III|"Patients receive oral ramipril twice daily on days 1-7.
laboratory biomarker analysis: Correlative studies
ramipril: Given orally"
244354|NCT01234922|B2|Baseline|Arm II|"Patients receive oral lisinopril once daily on days 1-7.
lisinopril: Given orally
laboratory biomarker analysis: Correlative studies"
244355|NCT01234922|B1|Baseline|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.
laboratory biomarker analysis: Correlative studies
benazepril hydrochloride: Given orally"
244363|NCT01234922|O1|Outcome|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.
laboratory biomarker analysis: Correlative studies
benazepril hydrochloride: Given orally"
244364|NCT01234922|E4|Reported Event|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.
losartan potassium: Given orally
laboratory biomarker analysis: Correlative studies"
244365|NCT01234922|E3|Reported Event|Arm III|"Patients receive oral ramipril twice daily on days 1-7.
laboratory biomarker analysis: Correlative studies
ramipril: Given orally"
244366|NCT01234922|E2|Reported Event|Arm II|"Patients receive oral lisinopril once daily on days 1-7.
lisinopril: Given orally
laboratory biomarker analysis: Correlative studies"
244367|NCT01234922|E1|Reported Event|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.
laboratory biomarker analysis: Correlative studies
benazepril hydrochloride: Given orally"
244368|NCT01234883|B3|Baseline|Total|Total of all reporting groups
244369|NCT01234883|B2|Baseline|0.9% Saline|saline: IV saline solution dosed as clinically indicated for rehydration
244370|NCT01234883|B1|Baseline|Plasma-Lyte A|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
244371|NCT01234883|P2|Participant Flow|Saline|0.9% Normal Saline: IV saline solution dosed as clinically indicated for rehydration
244372|NCT01234883|P1|Participant Flow|Multiple Electrolyte Solution|Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP): IV multiple electrolyte solution dosed as clinically indicated for rehydration.
244373|NCT01234883|O2|Outcome|Saline|saline: IV saline solution dosed as clinically indicated for rehydration
244374|NCT01234883|O1|Outcome|Multiple Electrolyte Solution|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
244375|NCT01234883|E2|Reported Event|Saline|saline: IV saline solution dosed as clinically indicated for rehydration
244376|NCT01234883|E1|Reported Event|Multiple Electrolyte Solution|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
244377|NCT01234870|B1|Baseline|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.
adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
244378|NCT01234870|P1|Participant Flow|Ischemic Heart Disease Patients|Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
244379|NCT01234870|O1|Outcome|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.
adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
244380|NCT01234870|O1|Outcome|Ischemic Heart Disease Patients|Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
244381|NCT01234870|E1|Reported Event|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.
adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
244382|NCT01234831|B3|Baseline|Total|Total of all reporting groups
244383|NCT01234831|B2|Baseline|Passive Screening|Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
244384|NCT01234831|B1|Baseline|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
244385|NCT01234831|P2|Participant Flow|Passive Screening|Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
244386|NCT01234831|P1|Participant Flow|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
244387|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
244388|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
244389|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
244390|NCT01234831|O2|Outcome|Passive Screening|Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
244391|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
244392|NCT01234831|O2|Outcome|Passive Screening|Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
244393|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
244394|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
244395|NCT01234831|E1|Reported Event|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
244396|NCT01234714|B1|Baseline|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
244666|NCT01232569|P4|Participant Flow|Tocilizumab Auto-injector - Open-label Extension Period|Patients received tocilizumab 162 mg sc via auto-injector every 2 weeks for 72 weeks.
244397|NCT01234714|P1|Participant Flow|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
244398|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244399|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244400|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244401|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244402|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244403|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244404|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244405|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244406|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244407|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244408|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244409|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
244410|NCT01234714|O2|Outcome|Clavien-Dindo Grade ≥IV Complications|"Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade <IV complications.
These are typically life-threatening complication (including CNS complications) requiring ICU management.
Grade IVa: single organ dysfunction (including dialysis)
Grade IVb: multi-organ dysfunction"
244411|NCT01234714|O1|Outcome|Clavien-Dindo Grade <IV Complications|"Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade <IV complications.
No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification.
Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.
Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Blood transfusions and total parenteral nutrition are also included.
Grade III:Requiring surgical, endoscopic or radiological intervention"
244412|NCT01234714|E1|Reported Event|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
244413|NCT01234675|B1|Baseline|All Study Participants|2 treatment period, with each period 6 weeks and 7 day washout period Milnacipran in treatment period 1, Placebo in treatment period 2 Placebo treatment in Period 1, and Milnacipran in Period 2
244414|NCT01234675|P2|Participant Flow|Milnacipran Then Placebo|50 mg BiD maintenance dose
244415|NCT01234675|P1|Participant Flow|Placebo Then Milnacipran|50 mg BiD maintenance dose
244416|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
244417|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
244418|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
244419|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
244420|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
244421|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
244422|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
244423|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
244424|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
244425|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
244426|NCT01234675|E2|Reported Event|Placebo|Drug: Placebo 50 mg, twice daily for 4 weeks.
244427|NCT01234675|E1|Reported Event|Milnacipran|Drug: milnacipran, 50 mg twice daily for 4 weeks.
244428|NCT01234467|B1|Baseline|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
244429|NCT01234467|P1|Participant Flow|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
244519|NCT01233869|B1|Baseline|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
289090|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
244430|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
244431|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
244432|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
244433|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
244434|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
244435|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
244436|NCT01234467|E1|Reported Event|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
244437|NCT01234337|B3|Baseline|Total|Total of all reporting groups
244438|NCT01234337|B2|Baseline|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244439|NCT01234337|B1|Baseline|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244440|NCT01234337|P2|Participant Flow|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244798|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244441|NCT01234337|P1|Participant Flow|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244442|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244443|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244444|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244445|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244446|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244447|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244448|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244449|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244450|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244451|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244452|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244520|NCT01233869|P4|Participant Flow|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244667|NCT01232569|P3|Participant Flow|Tocilizumab Pre-filled Syringe - Open-label Extension Period|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.
244453|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244454|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244455|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244456|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244457|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244458|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244459|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244460|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244461|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244462|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244463|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244464|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244465|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244466|NCT01234337|E2|Reported Event|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
244467|NCT01234337|E1|Reported Event|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
244468|NCT01234207|B1|Baseline|All Study Participants|Crossover trial: all study participants received both Test and Control spectacles, in randomized order.
244469|NCT01234207|P2|Participant Flow|Group 2 - Test Spectacles Worn First, Then Control Spectacles|Crossover trial; 2 arms: subjects randomized to wear Test spectacles 1st, then Control spectacles 2nd
244470|NCT01234207|P1|Participant Flow|Group 1 - Control Spectacles Worn First, Then Test Spectacles|Crossover trial; 2 arms: subjects randomized to wear Control spectacles 1st, then Test spectacles 2nd
244471|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
244472|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
244473|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
244474|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
244475|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
244476|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
244477|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
244478|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
244479|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
244480|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
244481|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
244482|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
244483|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
244484|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
244485|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
244486|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
244487|NCT01234207|E2|Reported Event|Test Spectacles|"Arm/Groups Adverse Events are reported per intervention"
244488|NCT01234207|E1|Reported Event|Control Spectacles|"Arm/Groups Adverse Events are reported per intervention"
244489|NCT01234103|B3|Baseline|Total|Total of all reporting groups
244490|NCT01234103|B2|Baseline|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
244491|NCT01234103|B1|Baseline|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
244492|NCT01234103|P2|Participant Flow|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
244493|NCT01234103|P1|Participant Flow|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
244562|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244494|NCT01234103|O2|Outcome|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
244495|NCT01234103|O1|Outcome|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
244496|NCT01234103|O2|Outcome|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
244497|NCT01234103|O1|Outcome|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
244498|NCT01234103|E2|Reported Event|Improving Nutrition, Fitness and Injury Prevention|"The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
244499|NCT01234103|E1|Reported Event|Preventing Sexual Health Risks|"The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors."
244500|NCT01233999|B1|Baseline|Botox|single-drug dosage comparison cross-over study
244501|NCT01233999|P1|Participant Flow|Botox|Participants will be randomly assigned to receive 1 injection with Botulinum toxin A, 40 units in either the left or right hand.
244502|NCT01233999|O1|Outcome|Botox|single-drug dosage comparison cross-over study
244503|NCT01233999|E1|Reported Event|Botox|single-drug dosage comparison cross-over study
244504|NCT01233921|B3|Baseline|Total|Total of all reporting groups
244505|NCT01233921|B2|Baseline|Arm II (no Palifermin)|Patients do not receive palifermin.
244506|NCT01233921|B1|Baseline|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
244507|NCT01233921|P2|Participant Flow|Arm II (no Palifermin)|Patients do not receive palifermin.
244508|NCT01233921|P1|Participant Flow|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
244509|NCT01233921|O2|Outcome|Arm II (no Palifermin)|Patients do not receive palifermin.
244510|NCT01233921|O1|Outcome|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
244511|NCT01233921|O2|Outcome|Arm II (no Palifermin)|Patients do not receive palifermin.
244512|NCT01233921|O1|Outcome|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
244513|NCT01233921|E2|Reported Event|Arm II (no Palifermin)|Patients do not receive palifermin.
244514|NCT01233921|E1|Reported Event|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
244515|NCT01233869|B5|Baseline|Total|Total of all reporting groups
244516|NCT01233869|B4|Baseline|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244517|NCT01233869|B3|Baseline|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244518|NCT01233869|B2|Baseline|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244521|NCT01233869|P3|Participant Flow|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244522|NCT01233869|P2|Participant Flow|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244523|NCT01233869|P1|Participant Flow|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244524|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244525|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244526|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244527|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244528|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244529|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244530|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244531|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244532|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244533|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244534|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244535|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244536|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244537|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244538|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244539|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244540|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244541|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244656|NCT01233687|P1|Participant Flow|AMG 102 + Erlotinib|
244657|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
244658|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
244659|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
244542|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244543|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244544|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244545|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244546|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244547|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244548|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244549|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244550|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244551|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244552|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244553|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244554|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244555|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244556|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244557|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244558|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244559|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244560|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244561|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244660|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
244661|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
244668|NCT01232569|P2|Participant Flow|Placebo sc - Double-blind Treatment Period|Patients received placebo sc every 2 weeks for 24 weeks.
244563|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244564|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244565|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244566|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244567|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244568|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244569|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244570|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244571|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244572|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244573|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244574|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244575|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244576|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244577|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244578|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244579|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244580|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244581|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244582|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244583|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244584|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244585|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244586|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244587|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244588|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244589|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244590|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244591|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244592|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244593|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244594|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244595|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244596|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244597|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244598|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244599|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244600|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244601|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244602|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244603|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244604|NCT01233869|E4|Reported Event|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
244605|NCT01233869|E3|Reported Event|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
244606|NCT01233869|E2|Reported Event|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
244607|NCT01233869|E1|Reported Event|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
244608|NCT01233817|B1|Baseline|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
244609|NCT01233817|P1|Participant Flow|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
244610|NCT01233817|O1|Outcome|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
244611|NCT01233817|E1|Reported Event|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
244612|NCT01233726|B4|Baseline|Total|Total of all reporting groups
244613|NCT01233726|B3|Baseline|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Nutrition, Madrid, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
GLUCERNA SELECT group received 25 kcal / kg / day for 28 days, via gastric or transpyloric."
244614|NCT01233726|B2|Baseline|ISOSOURCE PROTEIN FIBRE|"Patients of this group will received ISOSOURCE PROTEIN FIBRE (Nestlé Health Science, barcelona, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
244615|NCT01233726|B1|Baseline|DIABA HP|"Patients of this group received new-generation diabetes-specific high-protein formula (Diaba HP®, Vegenat, Badajoz, Spain); as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
DIABA HP group received, 25 kcal / kg/ day for 28 days, via gastric or transpyloric."
244616|NCT01233726|P3|Participant Flow|GLUCERNA SELECT|"Patients of this group received GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
GLUCERNA SELECT group will received 25 kcal / kg / day for 28 days, via gastric or transpyloric."
244617|NCT01233726|P2|Participant Flow|ISOSOURCE PROTEIN FIBRE|"Patients of this group received ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
244618|NCT01233726|P1|Participant Flow|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
244619|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244620|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244621|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
Group Diaba HP received, 25 kcal / kg /day for 28 days"
244622|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244623|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244624|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
244662|NCT01233687|E1|Reported Event|AMG 102 + Erlotinib|"Serious and Non-Serious Adverse Events include the events considered at least possibly, probably or definitely related to study treatment.
Non-Serious (Other) Adverse Events include those that occurred with a frequency of more than or equal to 5%."
244663|NCT01232569|B3|Baseline|Total|Total of all reporting groups
244625|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244626|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244627|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
244628|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244629|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244630|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
244631|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244632|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244633|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
Group Diaba HP received, 25 kcal / kg /day for 28 days"
244634|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244635|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244636|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
Group Diaba HP received, 25 kcal / kg /day for 28 days"
244637|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244638|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244639|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
Group Diaba HP received, 25 kcal / kg /day for 28 days"
289091|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
244640|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244641|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244642|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
Group Diaba HP received, 25 kcal / kg /day for 28 days"
244643|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244644|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244645|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
Group Diaba HP received, 25 kcal / kg /day for 28 days"
244646|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244647|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244648|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
Group Diaba HP received, 25 kcal / kg /day for 28 days"
244649|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244650|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
244651|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
Group Diaba HP received, 25 kcal / kg /day for 28 days"
244652|NCT01233726|E3|Reported Event|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg/ day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
GLUCERNA SELECT group will receive 25 kcal / kg / day for 28 days, via gastric or transpyloric."
244653|NCT01233726|E2|Reported Event|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
244654|NCT01233726|E1|Reported Event|DIABA HP|"Patients of this group received Diaba HP® as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
244655|NCT01233687|B1|Baseline|AMG 102 + Erlotinib|
244669|NCT01232569|P1|Participant Flow|Tocilizumab 162 mg sc - Double-blind Treatment Period|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244670|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244671|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244672|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244673|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244674|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244675|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244676|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244677|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244678|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244679|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244680|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244681|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244682|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244683|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244684|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244685|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244686|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244687|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244688|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244689|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244690|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244691|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244692|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244693|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244694|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244695|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244696|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244697|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244698|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244699|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244700|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244701|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244702|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
244703|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
244704|NCT01232569|E5|Reported Event|Placebo Pre-filled Syringe to Tocilizumab Autoinjector|Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.
244705|NCT01232569|E4|Reported Event|Placebo Pre-filled Syringe to Tocilizumab Pre-filled Syringe|Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.
244706|NCT01232569|E3|Reported Event|Tocilizumab Pre-filled Syringe to Tocilizumab Auto-injector|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.
244707|NCT01232569|E2|Reported Event|Placebo Pre-filled Syringe|Patients received placebo subcutaneously (sc) via a pre-filled syringe every 2 weeks for 24 weeks.
244708|NCT01232569|E1|Reported Event|Tocilizumab Pre-filled Syringe|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks. In addition, this reporting group includes participants re-randomized at Week 24 to tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks (Weeks 25-96).
244709|NCT01232504|B4|Baseline|Total|Total of all reporting groups
244710|NCT01232504|B3|Baseline|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244711|NCT01232504|B2|Baseline|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244712|NCT01232504|B1|Baseline|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244713|NCT01232504|P3|Participant Flow|rhG-CSF Group|subcutaneous recombinant human granulocyte stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244714|NCT01232504|P2|Participant Flow|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) and 2-3μg/kg/d recombinant human granulocyte stimulating factor (rhG-CSF) each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244715|NCT01232504|P1|Participant Flow|rhGM-CSF Group|subcutaneous recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244716|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244717|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244718|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244719|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244720|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244721|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244722|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244723|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244724|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244725|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244726|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244727|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244728|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244729|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244730|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244731|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244732|NCT01232504|O2|Outcome|rhG-CSF+ rhGM-CSF|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244733|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244734|NCT01232504|O3|Outcome|rhG-CSF|"5-7μg/kg per day
rhG-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
244735|NCT01232504|O2|Outcome|rhGM-CSF Plus rhG-CSF|"rhGM-CSF and rhG-CSF both at 2-3μg/kg per day
rhGM-CSF plus rhG-CSF: rhGM-CSF and rhG-CSF (both at 2-3μg/kg/d) subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
244736|NCT01232504|O1|Outcome|rhGM-CSF|"5-7μg/kg per day
rhGM-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
244737|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244738|NCT01232504|O2|Outcome|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244739|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244740|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244797|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244741|NCT01232504|O2|Outcome|rhG-CSF + rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244742|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244743|NCT01232504|E3|Reported Event|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244744|NCT01232504|E2|Reported Event|rhG-CSF + rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244745|NCT01232504|E1|Reported Event|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
244746|NCT01232491|B3|Baseline|Total|Total of all reporting groups
244747|NCT01232491|B2|Baseline|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
244748|NCT01232491|B1|Baseline|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
244749|NCT01232491|P2|Participant Flow|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
244750|NCT01232491|P1|Participant Flow|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
244751|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
244752|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
244753|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
244754|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
244755|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
244756|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
244757|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
244758|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
244759|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
244760|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
244761|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
244762|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
289092|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
244763|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
244764|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
244765|NCT01232491|E2|Reported Event|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
244766|NCT01232491|E1|Reported Event|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
244767|NCT01232465|B3|Baseline|Total|Total of all reporting groups
244768|NCT01232465|B2|Baseline|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
244769|NCT01232465|B1|Baseline|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
244770|NCT01232465|P2|Participant Flow|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
244771|NCT01232465|P1|Participant Flow|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
244772|NCT01232465|O2|Outcome|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
244773|NCT01232465|O1|Outcome|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
244774|NCT01232465|E2|Reported Event|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
244775|NCT01232465|E1|Reported Event|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
244776|NCT01233284|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
244777|NCT01233284|P5|Participant Flow|Placebo/Tio R2.5 qd/Tio R5 qd/Tio R1.25 qd|Patient treated with a matching Placebo in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
244778|NCT01233284|P4|Participant Flow|Placebo/Tio R5 qd/Tio R2.5 qd/Tio R1.25 qd|Patients treated with a matching Placebo in period 1 (evening), with Tiotropium 5 mcg in period 2 (evening), with Tiotropium 2.5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
244779|NCT01233284|P3|Participant Flow|Tio R1.25 qd/Tio R2.5 qd/Tio R5 qd/Placebo|Patients treated with Tiotropium 1.25 mcg in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with a matching placebo in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroid ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
244780|NCT01233284|P2|Participant Flow|Tio R2.5 qd/Placebo/Tio R1.25 qd/Tio R5 qd|Patients treated with Tiotropium 2.5 mcg in period 1 (evening), with a matching Placebo in period 2 (evening), with Tiotropium 1.25 mcg in period 3 (evening) and with Tiotropium 5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
244781|NCT01233284|P1|Participant Flow|Tio R5 Once Daily(qd)/Tio R1.25 qd/Placebo/Tio R2.5 qd|Patients treated with Tiotropium 5 mcg in period 1 (evening), with Tiotropium 1.25 mcg in period 2 (evening), with a matching Placebo in period 3 (evening) and with Tiotropium 2.5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroids (ICS). No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
244782|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244783|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244784|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244785|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244786|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244787|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244788|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244789|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244790|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244791|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244792|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244793|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244794|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244795|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244796|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244799|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244800|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244801|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244802|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244803|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244804|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244805|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244806|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244807|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244808|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244809|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244810|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244811|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244812|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244813|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244814|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244815|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244816|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244817|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244818|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244819|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244820|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244821|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244822|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244823|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244824|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244825|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244826|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244827|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244828|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244829|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244830|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244831|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244832|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244833|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244834|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244835|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244836|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244837|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244838|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244839|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244840|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244841|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244842|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244843|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244844|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244845|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244846|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244847|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244848|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244849|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244850|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244851|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244852|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244853|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244854|NCT01233284|E4|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244855|NCT01233284|E3|Reported Event|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244856|NCT01233284|E2|Reported Event|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
244857|NCT01233284|E1|Reported Event|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
244858|NCT01233258|B4|Baseline|Total|Total of all reporting groups
244859|NCT01233258|B3|Baseline|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
244860|NCT01233258|B2|Baseline|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
244861|NCT01233258|B1|Baseline|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
244862|NCT01233258|P6|Participant Flow|High Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII(BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
244863|NCT01233258|P5|Participant Flow|High Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
244864|NCT01233258|P4|Participant Flow|Low Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
244865|NCT01233258|P3|Participant Flow|Low Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII(BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
244866|NCT01233258|P2|Participant Flow|On Demand, BAY 81-8973 Potency First ADJ Then EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ for 6 months, followed by cross-over to study drug assayed by CS/EP for 6 months.
244867|NCT01233258|P1|Participant Flow|On Demand, BAY 81-8973 Potency First EP Then ADJ|Participants received on-demand treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months, followed by cross-over to study drug assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months.
244868|NCT01233258|O3|Outcome|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
244869|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
244870|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
244871|NCT01233258|O3|Outcome|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
244872|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
244873|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
244874|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
244875|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months
244876|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/ADJ|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
244932|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244877|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
244878|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/EP|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months.
244879|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months
244880|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
244881|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
244882|NCT01233258|E1|Reported Event|rFVIII (BAY81-8973) Treatment|Participants received on-demand or prophylaxis treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization
244883|NCT01233232|B4|Baseline|Total|Total of all reporting groups
244884|NCT01233232|B3|Baseline|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244885|NCT01233232|B2|Baseline|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244886|NCT01233232|B1|Baseline|Placebo|4 x placebo capsules, twice daily (bid)
244887|NCT01233232|P3|Participant Flow|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244888|NCT01233232|P2|Participant Flow|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244889|NCT01233232|P1|Participant Flow|Placebo|4 x placebo capsules, twice daily (bid)
244890|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244891|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244892|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244893|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244894|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244895|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244896|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244897|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244898|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244899|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244900|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244901|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244902|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244903|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244904|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244905|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244906|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244907|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244908|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244909|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244910|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244911|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244912|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244913|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244914|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244915|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244916|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244917|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244918|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244919|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244920|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244921|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244922|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244923|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244924|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244925|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244926|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244927|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244928|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244929|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244930|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244931|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244933|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244934|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244935|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244936|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244937|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
244938|NCT01233232|E3|Reported Event|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
244939|NCT01233232|E2|Reported Event|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
244940|NCT01233232|E1|Reported Event|Placebo|4 x placebo capsules, twice daily (bid)
244941|NCT01233076|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
244942|NCT01233076|P2|Participant Flow|Narafilcon B / Nelfilcon A|Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
244943|NCT01233076|P1|Participant Flow|Nelfilcon A / Narafilcon B|Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
244944|NCT01233076|O2|Outcome|Narafilcon B|Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
244945|NCT01233076|O1|Outcome|Nelfilcon A|Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
244946|NCT01233076|E2|Reported Event|Narafilcon B|Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
244947|NCT01233076|E1|Reported Event|Nelfilcon A|Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
244948|NCT01232920|B3|Baseline|Total|Total of all reporting groups
244949|NCT01232920|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
244950|NCT01232920|B1|Baseline|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
244951|NCT01232920|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
244952|NCT01232920|P1|Participant Flow|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
244953|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
244954|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
244955|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
245092|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
244956|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
244957|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
244958|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
244959|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
244960|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
244961|NCT01232920|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
244962|NCT01232920|E1|Reported Event|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
244963|NCT01232894|B3|Baseline|Total|Total of all reporting groups
244964|NCT01232894|B2|Baseline|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
244965|NCT01232894|B1|Baseline|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
244966|NCT01232894|P2|Participant Flow|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
244967|NCT01232894|P1|Participant Flow|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
244968|NCT01232894|O2|Outcome|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
244969|NCT01232894|O1|Outcome|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
244970|NCT01232894|E2|Reported Event|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
244971|NCT01232894|E1|Reported Event|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
244972|NCT01232868|B3|Baseline|Total|Total of all reporting groups
244973|NCT01232868|B2|Baseline|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
244974|NCT01232868|B1|Baseline|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
244975|NCT01232868|P2|Participant Flow|Age ≥65 Years|Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
244976|NCT01232868|P1|Participant Flow|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
244977|NCT01232868|O2|Outcome|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
244978|NCT01232868|O1|Outcome|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
244979|NCT01232868|O2|Outcome|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
244980|NCT01232868|O1|Outcome|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
244981|NCT01232868|E2|Reported Event|Age ≥65 Years|Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
244982|NCT01232868|E1|Reported Event|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
244983|NCT01232829|B1|Baseline|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
244984|NCT01232829|P1|Participant Flow|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
244985|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
244986|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
244987|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
244988|NCT01232829|E1|Reported Event|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
244989|NCT01232790|B1|Baseline|Participants|This is the overall group of trial participants prior to randomization to either of the two crossover arms in the study.
244990|NCT01232790|P2|Participant Flow|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
244991|NCT01232790|P1|Participant Flow|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
244992|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
244993|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
244994|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
244995|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
244996|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
244997|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
244998|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
244999|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245000|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
245001|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245093|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (weeks 0-16)
289093|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
245002|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
245003|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245004|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
245005|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245006|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
245007|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245008|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
245009|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245010|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
245011|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
245012|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
245013|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245014|NCT01232790|O2|Outcome|Placebo|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
245015|NCT01232790|O1|Outcome|Intervention|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245016|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
245017|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
245018|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
245019|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245020|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
245021|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245022|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
245023|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245094|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
246039|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
245024|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
245025|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245026|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
245027|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
245028|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
245029|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
245030|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
245031|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
245032|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and the receives rge commercially available sustained release form of NAC, in each arm the capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245033|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
245034|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
245035|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
245036|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
245037|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
245038|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
245039|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
245040|NCT01232790|E4|Reported Event|NAC: Second Crossover Follow Up|This group of participants received the active treatment (NAC) on the second day of the crossover study.
245041|NCT01232790|E3|Reported Event|Placebo: Second Crossover Follow Up|This group of participants received the placebo on the second day in the crossover design.
245042|NCT01232790|E2|Reported Event|NAC: First Crossover Follow Up|This group of participants received the active treatment (NAC) on the first day of the crossover study.
245043|NCT01232790|E1|Reported Event|Placebo: First Crossover Follow Up|This group of participants received the placebo on the first day in the crossover design.
245044|NCT01232296|B3|Baseline|Total|Total of all reporting groups
245045|NCT01232296|B2|Baseline|Sorafenib|400 mg tablet p.o. b.i.d.
245046|NCT01232296|B1|Baseline|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
245047|NCT01232296|P2|Participant Flow|Sorafenib|400 mg tablet p.o. b.i.d.
245048|NCT01232296|P1|Participant Flow|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
245049|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
245050|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
245051|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
245052|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
245053|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
245054|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
245055|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
245056|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
245057|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
245058|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
245059|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
245060|NCT01232296|E2|Reported Event|Sorafenib|400 mg tablet p.o. b.i.d.
245061|NCT01232296|E1|Reported Event|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
245062|NCT01232283|B3|Baseline|Total|Total of all reporting groups
245063|NCT01232283|B2|Baseline|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo controlled Phase (weeks 0-16).
245064|NCT01232283|B1|Baseline|Apremilast|Participants were initially randomized to Apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
245065|NCT01232283|P8|Participant Flow|PBO-APR-APR + Optional Topicals/Phototherapy|Participants who were initially randomized to PBO BID during the 16-week Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered non-responders (ie, having a response of <PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these partial or non-responders received additional topical or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on APR 30 mg BID for the remainder of their participation.
246040|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
245066|NCT01232283|P7|Participant Flow|APR-APR-APR + Optional Topicals/Phototherapy|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered non-responders (ie, having a response of <PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on APR 30 mg BID for the remainder of their participation.
245067|NCT01232283|P6|Participant Flow|APR-APR Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to APR during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on APR 30 mg BID for the remainder of their participation.
245068|NCT01232283|P5|Participant Flow|APR-APR-Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost ≥50% PASI improvement achieved at Week 32, were switched back to APR 30 mg BID at the time the loss was observed. Those participants who did not lose at least 50% of the PASI response remained on PBO until Week 52. All participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and received APR 30 mg BID for the remainder of their participation.
245069|NCT01232283|P4|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to PBO BID during the Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (Weeks 16-32)
245070|NCT01232283|P3|Participant Flow|Apremilast-Apremilast|Participants who were initially randomized to APR 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 30 mg BID during the Maintenance Phase (Weeks 16-32).
245071|NCT01232283|P2|Participant Flow|Placebo|Participants initially randomized to identically matching placebo tablets (PBO) BID during the Placebo controlled Phase (Weeks 0-16)
245072|NCT01232283|P1|Participant Flow|Apremilast|Participants initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
245073|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
245074|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
245075|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
245076|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
245077|NCT01232283|O2|Outcome|APR-APR -Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to APR 30mg BID during the Randomized Withdrawal Phase (Weeks 32-52).
245078|NCT01232283|O1|Outcome|APR-APR Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost ≥50% PASI improvement achieved at Week 32, were switched back to APR 30 mg BID at the time this loss was observed. Those participants who did not lose at least 50% of the PASI response from baseline through the Randomized Withdrawal Phase remained on PBO until Week 52.
245079|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
245080|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
245081|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
245082|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
245083|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
245084|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
245085|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
245086|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
245087|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
245088|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
245089|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo-controlled Phase (weeks 0-16)
245090|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
245091|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
246041|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
245095|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
245096|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
245097|NCT01232283|E4|Reported Event|APR-Exposure Period: Weeks 0-52|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16), up until Week 52. Adverse events associated with 30 mg apremilast treatment up to Week 52 were included.
245098|NCT01232283|E3|Reported Event|APR-APR-PBO: Weeks 32-52|Participants re-randomized to placebo tablets BID at Week 32. Includes data from Week 32 up to Week 52 when participants received placebo treatment.
245099|NCT01232283|E2|Reported Event|Placebo: Weeks 0-16|Participants randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
245100|NCT01232283|E1|Reported Event|Apremilast: Weeks 0-16|Participants randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
245101|NCT01232205|B3|Baseline|Total|Total of all reporting groups
245102|NCT01232205|B2|Baseline|Control|
245103|NCT01232205|B1|Baseline|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
245104|NCT01232205|P2|Participant Flow|Control|
245105|NCT01232205|P1|Participant Flow|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
245106|NCT01232205|O2|Outcome|Control|
245107|NCT01232205|O1|Outcome|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
245108|NCT01232205|E2|Reported Event|Control|
245109|NCT01232205|E1|Reported Event|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
245110|NCT01232127|B1|Baseline|All Treated|
245111|NCT01232127|P3|Participant Flow|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245112|NCT01232127|P2|Participant Flow|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245113|NCT01232127|P1|Participant Flow|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI). Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245114|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245115|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245116|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245117|NCT01232127|O1|Outcome|All Treated|All participants who received at least 1 dose of atazanavir with ritonavir and tenofovir and with or without famotidine.
245118|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245119|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245120|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245121|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245122|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245123|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus TDF, 300 mg QD, and at least 1 NRTI on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
246042|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
245124|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245125|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245126|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI)on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245127|NCT01232127|O1|Outcome|All Treated|All participants who received at least 1 dose of atazanavir with ritonavir and tenofovir and with or without famotidine.
245128|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245129|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245130|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245131|NCT01232127|E3|Reported Event|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF
245132|NCT01232127|E2|Reported Event|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245133|NCT01232127|E1|Reported Event|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
245134|NCT01231984|B3|Baseline|Total|Total of all reporting groups
245135|NCT01231984|B2|Baseline|4 mm vs. 12.7 mm|Subjects randomized to this study arm first use either the 4mm PN or the 12.7mm PN for 12 weeks, then switch to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
245136|NCT01231984|B1|Baseline|4 mm vs. 8 mm|Subjects randomized to this study arm first use either the 4mm PN or the 8mm PN for 12 weeks, then switched to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
245137|NCT01231984|P4|Participant Flow|12.7 mm First ( 4 vs.12.7)|Subjects randomized to this sequence used the 12.7 mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
245138|NCT01231984|P3|Participant Flow|4 mm First (4 vs.12.7)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 12.7 mm PN for the next 12 weeks (Period 2).
245139|NCT01231984|P2|Participant Flow|8 mm First (4 vs.8)|Subjects randomized to this sequence used the 8mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
245140|NCT01231984|P1|Participant Flow|4 mm First (4 vs.8)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 8 mm PN for the next 12 weeks (Period 2).
245141|NCT01231984|O3|Outcome|12.7mm Needle|Number of subjects enrolled who were assigned to use the 12.7mm PN.
245142|NCT01231984|O2|Outcome|8mm Needle|Number of subjects enrolled who were assigned to use the 8mm PN.
245143|NCT01231984|O1|Outcome|4mm Needle|Number of subjects enrolled who were assigned to use the 4mm PN.
245144|NCT01231984|O2|Outcome|12.7 mm First (4 vs. 12.7)|Subjects randomized to this sequence used the 12.7 mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
245145|NCT01231984|O1|Outcome|4 mm First (4 vs. 12.7)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 12.7 mm PN for the next 12 weeks (Period 2).
245146|NCT01231984|O3|Outcome|12.7mm Needle|Number of subjects enrolled who were assigned to use the 12.7mm PN.
245147|NCT01231984|O2|Outcome|8mm Needle|Number of subjects enrolled who were assigned to use the 8mm PN.
245148|NCT01231984|O1|Outcome|4mm Needle|Number of subjects enrolled who were assigned to use the 4mm PN.
245149|NCT01231984|O2|Outcome|12 mm Among Those in 4 mm x 12 mm Arm|Subjects randomized to this study arm first used the 4mm PN for 12 weeks, then switched to the 12mm PN for another 12 weeks.
245150|NCT01231984|O1|Outcome|4 mm Among Those in 12mm x 4mm Arm|Subjects randomized to this study arm first used the 12mm PN for 12 weeks, then switched to the 4mm PN for another 12 weeks.
245151|NCT01231984|O2|Outcome|8 mm Among Those in 4mm x 8mm Arm|Subjects randomized to this study arm first used the 4mm PN for 12 weeks, then switched to the 8mm PN for another 12 weeks.
245152|NCT01231984|O1|Outcome|4 mm Among Those in 8mm x 4 mm Arm|Subjects randomized to this study arm first used the 8mm PN for 12 weeks, then switched to the 4mm PN for another 12 weeks.
245191|NCT01231646|E1|Reported Event|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
245153|NCT01231984|O2|Outcome|Longer PN First (8mm or 12.7mm)|Subjects in this group first used one of the longer PNs (8 mm or 12 mm PN) for 12 weeks in Period 1, based on the randomization, then switched to the 4mm PN for another 12 weeks in Period 2.
245154|NCT01231984|O1|Outcome|4 mm First|Subjects in this group first used the 4 mm PN for 12 weeks in Period 1, then switched to a longer PN (8 mm or 12 mm PN) for another 12 weeks in Period 2, based on their randomization.
245155|NCT01231984|O2|Outcome|8 mm First (4 vs. 8)|Subjects randomized to this sequence used the 8mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
245156|NCT01231984|O1|Outcome|4 mm First (4 vs. 8)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 8 mm PN for the next 12 weeks (Period 2).
245157|NCT01231984|E3|Reported Event|12.7mm Needle|
245158|NCT01231984|E2|Reported Event|8mm Needle|
245159|NCT01231984|E1|Reported Event|4mm Needle|
245160|NCT01231841|B1|Baseline|rATG|Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
245161|NCT01231841|P1|Participant Flow|Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin)|Patients received rabbit anti-thymocyte globulin IV daily over 4-24 hours on days 1-5 (3.5 mg/kg/day). Beginning on day 6, patients received oral cyclosporine twice daily (5 mg/kg/day) for a period of 6 months and then tapered.
245162|NCT01231841|O1|Outcome|Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin)|Patients received rabbit anti-thymocyte globulin IV daily over 4-24 hours on days 1-5 (3.5 mg/kg/day). Beginning on day 6, patients received oral cyclosporine twice daily (5 mg/kg/day) for a period of 6 months and then tapered.
245163|NCT01231841|E1|Reported Event|rATG|Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
245164|NCT01231750|B3|Baseline|Total|Total of all reporting groups
245165|NCT01231750|B2|Baseline|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise
Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
245166|NCT01231750|B1|Baseline|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
245167|NCT01231750|P2|Participant Flow|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise
Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
245168|NCT01231750|P1|Participant Flow|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
245169|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise
Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
245170|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
245171|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise
Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
245172|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
245173|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise
Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
245174|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
245175|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise
Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
245176|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
245177|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise
Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
245178|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
245179|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise
Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
245180|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
245181|NCT01231750|E2|Reported Event|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise
Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
245182|NCT01231750|E1|Reported Event|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
245183|NCT01231646|B3|Baseline|Total|Total of all reporting groups
245184|NCT01231646|B2|Baseline|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
245185|NCT01231646|B1|Baseline|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
245186|NCT01231646|P2|Participant Flow|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
245187|NCT01231646|P1|Participant Flow|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
245188|NCT01231646|O2|Outcome|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
245189|NCT01231646|O1|Outcome|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
245190|NCT01231646|E2|Reported Event|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
245197|NCT01231607|B1|Baseline|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
245198|NCT01231607|P5|Participant Flow|Placebo|Matching dutasteride placebo and finasteride placebo once daily
245199|NCT01231607|P4|Participant Flow|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
245200|NCT01231607|P3|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
245201|NCT01231607|P2|Participant Flow|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
245202|NCT01231607|P1|Participant Flow|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
245203|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245204|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245205|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245206|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245207|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245208|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245209|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245210|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245211|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245212|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245213|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245214|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245215|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245216|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245217|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245218|NCT01231607|O3|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245219|NCT01231607|O2|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245220|NCT01231607|O1|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245221|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245222|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245223|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245224|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245225|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245226|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245227|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245228|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245229|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245230|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245231|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245232|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245233|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245234|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245235|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245236|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245237|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245238|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245239|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245240|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245241|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245242|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245243|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245244|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245245|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245246|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245247|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245248|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245249|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245250|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245251|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245252|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245253|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245254|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245255|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245256|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245257|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245258|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245259|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245260|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245261|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245262|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245263|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245264|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245265|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245266|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245267|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245268|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245269|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245574|NCT01231464|O1|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
245270|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245271|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245272|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245273|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245274|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245275|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245276|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245277|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245278|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245279|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245280|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245281|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
245282|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245283|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245284|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
245285|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
245286|NCT01231607|E5|Reported Event|Placebo|Matching dutasteride placebo and finasteride placebo once daily
245287|NCT01231607|E4|Reported Event|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
245288|NCT01231607|E3|Reported Event|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
245289|NCT01231607|E2|Reported Event|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
245290|NCT01231607|E1|Reported Event|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
245291|NCT01231581|B3|Baseline|Total|Total of all reporting groups
245292|NCT01231581|B2|Baseline|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245293|NCT01231581|B1|Baseline|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245294|NCT01231581|P2|Participant Flow|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245295|NCT01231581|P1|Participant Flow|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245296|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245297|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245575|NCT01231464|O2|Outcome|Placebo|Matching Vehicle Placebo Nasal Spray QD
245576|NCT01231464|O1|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
245298|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245299|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245300|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245301|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245302|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245303|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245304|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245305|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245306|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245307|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245308|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245309|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245310|NCT01231581|E2|Reported Event|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245311|NCT01231581|E1|Reported Event|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
245312|NCT01231516|B3|Baseline|Total|Total of all reporting groups
245313|NCT01231516|B2|Baseline|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
245314|NCT01231516|B1|Baseline|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
245315|NCT01231516|P2|Participant Flow|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
245316|NCT01231516|P1|Participant Flow|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
245317|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
245318|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
245319|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
245320|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
245321|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
245322|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
245323|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
245324|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
245325|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
245326|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
245327|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
245328|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
245577|NCT01231464|E2|Reported Event|Placebo|Matching Vehicle Placebo Nasal Spray QD
245329|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
245330|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
245331|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
245332|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
245333|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
245334|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
245335|NCT01231516|E2|Reported Event|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK continued to supply RAL in the Open-Label Phase until it was commercially available.
245336|NCT01231516|E1|Reported Event|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
245337|NCT01231503|B9|Baseline|Total|Total of all reporting groups
245338|NCT01231503|B8|Baseline|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245339|NCT01231503|B7|Baseline|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245340|NCT01231503|B6|Baseline|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245341|NCT01231503|B5|Baseline|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245578|NCT01231464|E1|Reported Event|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
245643|NCT01231230|B1|Baseline|All Study Participants|participant received in random order one of the four treatments ( fluticasone, salmeterol, fluticasone+salmeterol or placebo)
289094|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
245342|NCT01231503|B4|Baseline|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245343|NCT01231503|B3|Baseline|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245344|NCT01231503|B2|Baseline|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245345|NCT01231503|B1|Baseline|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245346|NCT01231503|P8|Participant Flow|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245347|NCT01231503|P7|Participant Flow|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245348|NCT01231503|P6|Participant Flow|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245349|NCT01231503|P5|Participant Flow|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245350|NCT01231503|P4|Participant Flow|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245644|NCT01231230|P1|Participant Flow|All Study Groups|"inhalation of 250 mcg of fluticasone
fluticasone: 220- mcg once"
245351|NCT01231503|P3|Participant Flow|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245352|NCT01231503|P2|Participant Flow|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245353|NCT01231503|P1|Participant Flow|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245354|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245355|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245356|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245357|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245358|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245359|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245754|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
245360|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245361|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245362|NCT01231503|O5|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245363|NCT01231503|O4|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245364|NCT01231503|O3|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245365|NCT01231503|O2|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245366|NCT01231503|O1|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245367|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245368|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246043|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
245369|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245370|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245371|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245372|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245373|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245374|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245375|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245376|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245377|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245755|NCT01230710|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
245378|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245379|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245380|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245381|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245382|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245383|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245384|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245385|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245386|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245756|NCT01230502|B4|Baseline|Total|Total of all reporting groups
245387|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245388|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245389|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245390|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245391|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245392|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245393|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245394|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245395|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246044|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
246045|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
245396|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245397|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245398|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245399|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245400|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245401|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245402|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245403|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245404|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246046|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
289095|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
245405|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245406|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245407|NCT01231503|O5|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245408|NCT01231503|O4|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245409|NCT01231503|O3|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245410|NCT01231503|O2|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245411|NCT01231503|O1|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245412|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245413|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246047|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
245414|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245415|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245416|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245417|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245418|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245419|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245420|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245421|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245422|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246048|NCT01229371|E4|Reported Event|Subjects >60 Years - CSL HA Antigen|
245423|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245424|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245425|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245426|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245427|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245428|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245429|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245430|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245431|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
289096|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
245432|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245433|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245434|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245435|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245436|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245437|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245438|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245439|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245440|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246049|NCT01229371|E3|Reported Event|Subjects >60 Years - AdImmune HA Antigen|
289097|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
245441|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245442|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245443|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245444|NCT01231503|O2|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245445|NCT01231503|O1|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245446|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245447|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245448|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245449|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246050|NCT01229371|E2|Reported Event|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
245450|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245451|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245452|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245453|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245454|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245455|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245456|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245457|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245458|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246051|NCT01229371|E1|Reported Event|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
246052|NCT01229228|B6|Baseline|Total|Total of all reporting groups
245459|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245460|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245461|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245462|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245463|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245464|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245465|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245466|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245467|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246053|NCT01229228|B5|Baseline|Placebo|
246054|NCT01229228|B4|Baseline|Naprosyn 500 mg|
245468|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245469|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245470|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245471|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245472|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245473|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245474|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245475|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245476|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246055|NCT01229228|B3|Baseline|Naprosyn 250 mg|
246056|NCT01229228|B2|Baseline|Naproxen Test (Upper Dose)|
245477|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245478|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245479|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245480|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245481|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245482|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245483|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245484|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245485|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246057|NCT01229228|B1|Baseline|Naproxen Test (Lower Dose)|
246058|NCT01229228|P5|Participant Flow|Placebo|
245486|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245487|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245488|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245489|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245490|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245491|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245492|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245493|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245494|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246059|NCT01229228|P4|Participant Flow|Naprosyn 500 mg|
246060|NCT01229228|P3|Participant Flow|Naprosyn 250 mg|
245495|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245496|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245497|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245498|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245499|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245500|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245501|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245502|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245503|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246061|NCT01229228|P2|Participant Flow|Naproxen Test (Upper Dose)|
245504|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245505|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245506|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245507|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245508|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245509|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245510|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245511|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245512|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246062|NCT01229228|P1|Participant Flow|Naproxen Test (Lower Dose)|
246063|NCT01229228|O5|Outcome|Placebo|
245513|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245514|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245515|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245516|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245517|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245518|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245519|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245520|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245521|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246064|NCT01229228|O4|Outcome|Naprosyn 500 mg|
245522|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245523|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245524|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245525|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245526|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245527|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245528|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245529|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245530|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246065|NCT01229228|O3|Outcome|Naprosyn 250 mg|
246066|NCT01229228|O2|Outcome|Naproxen Test (Upper Dose)|400-mg (2 x 200-mg)
245531|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245532|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245533|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245534|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245535|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245536|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245537|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245538|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245539|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246067|NCT01229228|O1|Outcome|Naproxen Test (Lower Dose)|200-mg single dose
246068|NCT01229228|E5|Reported Event|Placebo|
245540|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245541|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245542|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245543|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245544|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245545|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245546|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245547|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245548|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246069|NCT01229228|E4|Reported Event|Naprosyn 500 mg|
246070|NCT01229228|E3|Reported Event|Naprosyn 250 mg|
245549|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245550|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245551|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245552|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245553|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245554|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245555|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245556|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245557|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
246071|NCT01229228|E2|Reported Event|Naproxen Test (Upper Dose)|
245558|NCT01231503|E8|Reported Event|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245559|NCT01231503|E7|Reported Event|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245560|NCT01231503|E6|Reported Event|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245561|NCT01231503|E5|Reported Event|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245562|NCT01231503|E4|Reported Event|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245563|NCT01231503|E3|Reported Event|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245564|NCT01231503|E2|Reported Event|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245565|NCT01231503|E1|Reported Event|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
245566|NCT01231464|B3|Baseline|Total|Total of all reporting groups
245567|NCT01231464|B2|Baseline|Placebo|Matching Vehicle Placebo Nasal Spray QD
245568|NCT01231464|B1|Baseline|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
245569|NCT01231464|P2|Participant Flow|Placebo|Matching Vehicle Placebo Nasal Spray QD
245570|NCT01231464|P1|Participant Flow|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
245571|NCT01231464|O2|Outcome|Placebo|Matching Vehicle Placebo Nasal Spray QD
245572|NCT01231464|O1|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mg) once daily (QD)
245573|NCT01231464|O2|Outcome|Placebo|Matching Vehicle placebo nasal spray QD
245579|NCT01231399|B1|Baseline|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally"
245580|NCT01231399|P1|Participant Flow|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally"
245581|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally"
245582|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally"
245583|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally"
245584|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally"
245585|NCT01231399|E1|Reported Event|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
oxaliplatin: Given IV
everolimus: Given orally"
245586|NCT01231373|B5|Baseline|Total|Total of all reporting groups
245587|NCT01231373|B4|Baseline|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam therapeutic dose
245588|NCT01231373|B3|Baseline|Polidocanol Injectable Foam, 0.5%|polidocanol injectable foam lower experimental dose
245589|NCT01231373|B2|Baseline|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam active placebo
245590|NCT01231373|B1|Baseline|Vehicle|Vehicle: Injection of vehicle comparator
245591|NCT01231373|P4|Participant Flow|Polidocanol Injectable Foam, 1.0%|1.0% polidocanol foam injection
245592|NCT01231373|P3|Participant Flow|Polidocanol Injectable Foam, 0.5%|lower experimental polidocanol dose
245593|NCT01231373|P2|Participant Flow|Polidocanol Injectable Foam, 0.125%|active placebo for blinding of therapeutic polidocanol dose
245594|NCT01231373|P1|Participant Flow|Vehicle|Vehicle: Injection of vehicle comparator
245595|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, 1.0% experimental dose
245596|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
245597|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
245598|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
245599|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, experimental dose 1.0%
245600|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
245601|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
245602|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
245603|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, 1.0%: Injection of mid-dose PEM
245604|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
245605|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
245606|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
245607|NCT01231373|E4|Reported Event|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam target therapeutic dose
245608|NCT01231373|E3|Reported Event|Polidocanol Injectable Foam, 0.5%|polidocanol injectable foam, 0.5% lower experimental dose
245609|NCT01231373|E2|Reported Event|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125% active placebo
245610|NCT01231373|E1|Reported Event|Vehicle|Vehicle: Injection of vehicle comparator
245611|NCT01231334|B3|Baseline|Total|Total of all reporting groups
245612|NCT01231334|B2|Baseline|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
246072|NCT01229228|E1|Reported Event|Naproxen Test (Lower Dose)|
245613|NCT01231334|B1|Baseline|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
245614|NCT01231334|P2|Participant Flow|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
245615|NCT01231334|P1|Participant Flow|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
245616|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
245617|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
245618|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
245619|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
245620|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
245621|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
245622|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
245623|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
245624|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
245625|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
245626|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
245627|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
245628|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
245629|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
245630|NCT01231334|E2|Reported Event|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
245631|NCT01231334|E1|Reported Event|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
245632|NCT01231321|B1|Baseline|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
245633|NCT01231321|P1|Participant Flow|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
245634|NCT01231321|O1|Outcome|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
245635|NCT01231321|O2|Outcome|Above Reference Range|Subjects with vital sign values at Week 24 higher than the reference range indicated for each parameter
245636|NCT01231321|O1|Outcome|Below Reference Range|Subjects with vital sign values at Week 24 lower than the reference range indicated for each parameter
245637|NCT01231321|O2|Outcome|Above Reference Range|Subjects with laboratory values at Week 24 higher than the reference range indicated for each parameter
245638|NCT01231321|O1|Outcome|Below Reference Range|Subjects with laboratory values at Week 24 lower than the reference range indicated for each parameter
245639|NCT01231321|O2|Outcome|Change From Abnormal to Normal|Subjects whose physical examination findings for the categories below were abnormal at Baseline and normal at 24 weeks
245640|NCT01231321|O1|Outcome|Change From Normal to Abnormal|Subjects whose physical examination findings for the categories below were normal at Baseline and abnormal at 24 weeks
245641|NCT01231321|O1|Outcome|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
245642|NCT01231321|E1|Reported Event|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
246073|NCT01229176|B9|Baseline|Total|Total of all reporting groups
245645|NCT01231230|O4|Outcome|Fluticasone/Salmeterol|"inhalation of fluticasone 250mcg combined with salmeterol 50 mcg
fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol"
245646|NCT01231230|O3|Outcome|Salmeterol|"inhalation of salmeterol 50 mcg once
Salmeterol: 50 mcg salmeterol once
Salmeterol: 50 mcg once"
245647|NCT01231230|O2|Outcome|Placebo|"inhalation of placebo diskus
placebo inhalation: placebo inhalation once"
245648|NCT01231230|O1|Outcome|Fluticasone|"inhalation of 250 mcg of fluticasone
fluticasone: 220- mcg once"
245649|NCT01231230|E4|Reported Event|Fluticasone/Salmeterol|"inhalation of fluticasone 250mcg combined with salmeterol 50 mcg
fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol"
245650|NCT01231230|E3|Reported Event|Salmeterol|"inhalation of salmeterol 50 mcg once
Salmeterol: 50 mcg salmeterol once
Salmeterol: 50 mcg once"
245651|NCT01231230|E2|Reported Event|Placebo|"inhalation of placebo diskus
placebo inhalation: placebo inhalation once"
245652|NCT01231230|E1|Reported Event|Fluticasone|"inhalation of 250 mcg of fluticasone
fluticasone: 220- mcg once"
245653|NCT01230892|B3|Baseline|Total|Total of all reporting groups
245654|NCT01230892|B2|Baseline|Atenolol|Atenolol: 100 mg PO qday
245655|NCT01230892|B1|Baseline|Nebivolol|Nebivolol: 10 mg PO qday
245656|NCT01230892|P2|Participant Flow|Atenolol|Atenolol: 100 mg PO qday
245657|NCT01230892|P1|Participant Flow|Nebivolol|Nebivolol: 10 mg PO qday
245658|NCT01230892|O2|Outcome|Atenolol|Atenolol: 100 mg PO qday
245659|NCT01230892|O1|Outcome|Nebivolol|Nebivolol: 10 mg PO qday
245660|NCT01230892|E2|Reported Event|Atenolol|Atenolol: 100 mg PO qday
245661|NCT01230892|E1|Reported Event|Nebivolol|Nebivolol: 10 mg PO qday
245662|NCT01230827|B5|Baseline|Total|Total of all reporting groups
245663|NCT01230827|B4|Baseline|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
245664|NCT01230827|B3|Baseline|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
245665|NCT01230827|B2|Baseline|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
245666|NCT01230827|B1|Baseline|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
245667|NCT01230827|P4|Participant Flow|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
245668|NCT01230827|P3|Participant Flow|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
245669|NCT01230827|P2|Participant Flow|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
245670|NCT01230827|P1|Participant Flow|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
245671|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
245672|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
245673|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
245674|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
246074|NCT01229176|B8|Baseline|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
289098|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
245675|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
245676|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
245677|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
245678|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
245679|NCT01230827|E4|Reported Event|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
245680|NCT01230827|E3|Reported Event|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
245681|NCT01230827|E2|Reported Event|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
245682|NCT01230827|E1|Reported Event|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
245683|NCT01230814|B3|Baseline|Total|Total of all reporting groups
245684|NCT01230814|B2|Baseline|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
245685|NCT01230814|B1|Baseline|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
245686|NCT01230814|P2|Participant Flow|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
245687|NCT01230814|P1|Participant Flow|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
245688|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
245689|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
245690|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
245691|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
245692|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
245693|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
245694|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
245695|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
245696|NCT01230814|E2|Reported Event|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
245697|NCT01230814|E1|Reported Event|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
245698|NCT01230788|B1|Baseline|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
245699|NCT01230788|P1|Participant Flow|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
245700|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
245701|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
245702|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
245703|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
245704|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
245705|NCT01230788|E1|Reported Event|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
245706|NCT01230749|B5|Baseline|Total|Total of all reporting groups
245707|NCT01230749|B4|Baseline|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
245708|NCT01230749|B3|Baseline|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
245709|NCT01230749|B2|Baseline|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
245710|NCT01230749|B1|Baseline|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
245711|NCT01230749|P4|Participant Flow|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
245712|NCT01230749|P3|Participant Flow|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
245713|NCT01230749|P2|Participant Flow|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
245714|NCT01230749|P1|Participant Flow|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
245715|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
245716|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
245717|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
245718|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
245719|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
245720|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
245721|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
245722|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
245723|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
245724|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
245725|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
245726|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
245727|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
245728|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
245729|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
245730|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
245731|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
245732|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
245733|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
245734|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
245735|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
245736|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
245737|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
245738|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
245739|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
245740|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
245741|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
245742|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
245743|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
245744|NCT01230749|E4|Reported Event|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
245745|NCT01230749|E3|Reported Event|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
245746|NCT01230749|E2|Reported Event|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
245747|NCT01230749|E1|Reported Event|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
245748|NCT01230710|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
245749|NCT01230710|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
245750|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
245751|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
245752|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
245753|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
245757|NCT01230502|B3|Baseline|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive
Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:
Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.
Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.
Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
245758|NCT01230502|B2|Baseline|Group 2 Donor Specific Regulation DSR +; Standard of Care|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.
data and sample collection: Group 2 : DSR(+) standard of care:
These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.
Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
245759|NCT01230502|B1|Baseline|Group 3: Donor Specific Regulation DSR -, Standard of Care|"Subjects who test DSR (donor specific regulation) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.
data and sample collection: Group 3 : DSR(-) standard of care:
These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
245760|NCT01230502|P3|Participant Flow|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are Donor specific regulation (DSR) positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive
Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:
Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.
Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.
Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
245761|NCT01230502|P2|Participant Flow|Group 2 Donor Specific Regulation (DSR) +; Standard of Care|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.
data and sample collection: Group 2 : DSR (+)standard of care:
These subjects will be maintained on standard of care immunosuppression consisting of Tacrolimus and Mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.
Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
245762|NCT01230502|P1|Participant Flow|Group 3: Donor Specific Regulation (DSR) -, Standard of Care|"Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.
data and sample collection: Group 3 : DSR (-) standard of care:
These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
245763|NCT01230502|O3|Outcome|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive
Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:
Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.
Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.
Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
245764|NCT01230502|O2|Outcome|Group 2 Donor Specific Regulation (DSR) +; Standard of Care|"Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.
data and sample collection: Group 2 : DSR (+)standard of care:
These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.
Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
245765|NCT01230502|O1|Outcome|Group 3: Donor Specific Regulation (DSR) -, Standard of Care|"Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.
data and sample collection: Group 3 : DSR (-) standard of care:
These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
246290|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn.
245766|NCT01230502|O3|Outcome|Group 1 DSR (+), Withdrawal of Tacrolimus to MPA Monotherapy|"Subjects that are DSR positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive
Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:
Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.
Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.
Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
245767|NCT01230502|O2|Outcome|Group 2 DSR (+); Standard of Care|"Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.
data and sample collection: Group 2 : DSR (+)standard of care:
These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.
Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
245768|NCT01230502|O1|Outcome|Group 3: DSR (-), Standard of Care|"Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.
data and sample collection: Group 3 : DSR (-) standard of care:
These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
245769|NCT01230502|E3|Reported Event|Group 1 DSR (Donor Specific Regulation) (+),MPA Monotherapy|"Subjects that are Donor specific regulation DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive
Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:
Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.
Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.
Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
245770|NCT01230502|E2|Reported Event|Group 2 DSR (Donor Specific Regulation) (+); Standard of Care|"Subjects that are Donor specific regulation (DSR) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.
data and sample collection: Group 2 : DSR(+) standard of care:
These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.
Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
245771|NCT01230502|E1|Reported Event|Group 3: DSR (Donor Specific Regulation) (-), Standard of Care|"Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.
data and sample collection: Group 3 : DSR(-) standard of care:
These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
245772|NCT01230424|B3|Baseline|Total|Total of all reporting groups
245773|NCT01230424|B2|Baseline|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245774|NCT01230424|B1|Baseline|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245775|NCT01230424|P2|Participant Flow|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245776|NCT01230424|P1|Participant Flow|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245777|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245778|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245779|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245780|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245781|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245782|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245783|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245784|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245785|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245786|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245787|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245788|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245789|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245790|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245791|NCT01230424|O2|Outcome|Sodium Chloride|"0.9% Sodium chloride injection as Placebo will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245792|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245793|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245794|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245795|NCT01230424|O2|Outcome|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245796|NCT01230424|O1|Outcome|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245797|NCT01230424|O2|Outcome|0.9% Sodium Chloride|All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
245798|NCT01230424|O1|Outcome|Triamcinolone Acetonide 40mg|All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
245799|NCT01230424|E2|Reported Event|Sodium Chloride|"Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections."
245800|NCT01230424|E1|Reported Event|Triamcinolone Acetonide|"40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections."
245801|NCT01230307|B3|Baseline|Total|Total of all reporting groups
245802|NCT01230307|B2|Baseline|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.
Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
245803|NCT01230307|B1|Baseline|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months
Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
245804|NCT01230307|P2|Participant Flow|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.
Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
245805|NCT01230307|P1|Participant Flow|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months
Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
245806|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.
Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
245807|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months
Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
245808|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.
Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
245809|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months
Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
290076|NCT00122447|E1|Reported Event|Aspirin|Anti-inflammatory agent
245810|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.
Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
245811|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months
Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
245812|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.
Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
245813|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months
Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
245814|NCT01230307|E2|Reported Event|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.
Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
245815|NCT01230307|E1|Reported Event|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months
Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
245816|NCT01230177|B1|Baseline|Etanercept (Renetical Recombination)|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
245817|NCT01230177|P1|Participant Flow|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
245818|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
245819|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
245820|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
245821|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
245822|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
245823|NCT01230177|E1|Reported Event|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
245824|NCT01230060|B1|Baseline|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens
enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
245825|NCT01230060|P1|Participant Flow|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens
enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
245826|NCT01230060|O1|Outcome|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens
enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
245827|NCT01230060|E1|Reported Event|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens
enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
245828|NCT01230021|B1|Baseline|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245829|NCT01230021|P1|Participant Flow|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245830|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245831|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245832|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245833|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245897|NCT01229735|B1|Baseline|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
245834|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245835|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245836|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245837|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245838|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245839|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245840|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245841|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245842|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245843|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245844|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245845|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245846|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245847|NCT01230021|E1|Reported Event|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
245848|NCT01229943|B3|Baseline|Total|Total of all reporting groups
245849|NCT01229943|B2|Baseline|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >
> Bevacizumab: Given IV >
> Everolimus: Given PO >
> Octreotide Acetate: Given IM"
245850|NCT01229943|B1|Baseline|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >
> Octreotide Acetate: Given IM"
245851|NCT01229943|P2|Participant Flow|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >
> Bevacizumab: Given IV >
> Everolimus: Given PO >
> Octreotide Acetate: Given IM"
245852|NCT01229943|P1|Participant Flow|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >
> Octreotide Acetate: Given IM"
290077|NCT00122460|B3|Baseline|Total|Total of all reporting groups
245853|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.
Bevacizumab: Given IV
Everolimus: Given PO
Octreotide Acetate: Given IM"
245854|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.
Everolimus: Given PO
Octreotide Acetate: Given IM"
245855|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.
Bevacizumab: Given IV
Everolimus: Given PO
Octreotide Acetate: Given IM"
245856|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.
Everolimus: Given PO
Octreotide Acetate: Given IM"
245857|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >
> Bevacizumab: Given IV >
> Everolimus: Given PO >
> Octreotide Acetate: Given IM"
245858|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >
> Octreotide Acetate: Given IM"
245859|NCT01229943|E2|Reported Event|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.
Bevacizumab: Given IV
Everolimus: Given PO
Octreotide Acetate: Given IM"
245860|NCT01229943|E1|Reported Event|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.
Everolimus: Given PO
Octreotide Acetate: Given IM"
245861|NCT01229891|B4|Baseline|Total|Total of all reporting groups
245862|NCT01229891|B3|Baseline|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
245863|NCT01229891|B2|Baseline|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
245864|NCT01229891|B1|Baseline|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
245865|NCT01229891|P3|Participant Flow|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
245866|NCT01229891|P2|Participant Flow|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
245867|NCT01229891|P1|Participant Flow|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
245868|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
245869|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
245870|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
245871|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
245872|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
245873|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
245874|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
245875|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
245876|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
245877|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
245878|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
245879|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
245880|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
245881|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
245882|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
245883|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
245884|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
245885|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
245886|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
245887|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
245888|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
245889|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
245890|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
245891|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
245892|NCT01229891|E3|Reported Event|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
245893|NCT01229891|E2|Reported Event|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
245894|NCT01229891|E1|Reported Event|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
245895|NCT01229735|B3|Baseline|Total Title|
245896|NCT01229735|B2|Baseline|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
245898|NCT01229735|P2|Participant Flow|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
245899|NCT01229735|P1|Participant Flow|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
245900|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
245901|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
245902|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
245903|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
245904|NCT01229735|O2|Outcome|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
245905|NCT01229735|O1|Outcome|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
245906|NCT01229735|O2|Outcome|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
245907|NCT01229735|O1|Outcome|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
245908|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
245909|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
245910|NCT01229735|E2|Reported Event|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
245911|NCT01229735|E1|Reported Event|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
245912|NCT01229722|B3|Baseline|Total|Total of all reporting groups
245913|NCT01229722|B2|Baseline|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.
ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
245914|NCT01229722|B1|Baseline|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
245915|NCT01229722|P2|Participant Flow|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.
ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
245916|NCT01229722|P1|Participant Flow|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
245917|NCT01229722|O2|Outcome|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.
ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
246013|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
246014|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
245918|NCT01229722|O1|Outcome|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
245919|NCT01229722|E2|Reported Event|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.
ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
245920|NCT01229722|E1|Reported Event|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
245921|NCT01229527|B4|Baseline|Total|Total of all reporting groups
245922|NCT01229527|B3|Baseline|Meperidine|
245923|NCT01229527|B2|Baseline|Remifentanil RS2|
245924|NCT01229527|B1|Baseline|Remifentanil RS1|
245925|NCT01229527|P3|Participant Flow|Meperidine|
245926|NCT01229527|P2|Participant Flow|Remifentanil RS2|
245927|NCT01229527|P1|Participant Flow|Remifentanil RS1|
245928|NCT01229527|O3|Outcome|Meperidine|
245929|NCT01229527|O2|Outcome|Remifentanil RS2|
245930|NCT01229527|O1|Outcome|Remifentanil RS1|
245931|NCT01229527|O3|Outcome|Meperidine|
245932|NCT01229527|O2|Outcome|Remifentanil RS2|
245933|NCT01229527|O1|Outcome|Remifentanil RS1|
245934|NCT01229527|E3|Reported Event|Meperidine|
245935|NCT01229527|E2|Reported Event|Remifentanil RS2|
245936|NCT01229527|E1|Reported Event|Remifentanil RS1|
245937|NCT01229462|B3|Baseline|Total|Total of all reporting groups
245938|NCT01229462|B2|Baseline|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
245939|NCT01229462|B1|Baseline|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
245940|NCT01229462|P2|Participant Flow|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
245941|NCT01229462|P1|Participant Flow|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
245942|NCT01229462|O2|Outcome|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
245943|NCT01229462|O1|Outcome|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
245944|NCT01229462|E2|Reported Event|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
245945|NCT01229462|E1|Reported Event|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
245946|NCT01229436|B1|Baseline|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245947|NCT01229436|P1|Participant Flow|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
246015|NCT01229397|O3|Outcome|Inflexal V 0.5 mL x 1|
246016|NCT01229397|O2|Outcome|Inflexal V 0.25 mL x 2 - After 2nd Vaccination|
246017|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2 - After 1st Vaccination|
290454|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|
245948|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245949|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245950|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245951|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245952|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245953|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245954|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245955|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245956|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245957|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245958|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245959|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245960|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245961|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245962|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
246018|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
246019|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
245963|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245964|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245965|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245966|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245967|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245968|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245969|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245970|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245971|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245972|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245973|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245974|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245975|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245976|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245977|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
246020|NCT01229397|E3|Reported Event|Inflexal V 0.5 mL x 1|
246021|NCT01229397|E2|Reported Event|Inflexal V 0.25 mL x 2 - After 2nd Vaccination|
290561|NCT00117559|B3|Baseline|Total|Total of all reporting groups
245978|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245979|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245980|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245981|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245982|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245983|NCT01229436|E1|Reported Event|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
245984|NCT01229423|B1|Baseline|LATISSE®|bimatoprost 0.03% (LATISSE®)
245985|NCT01229423|P1|Participant Flow|LATISSE®|bimatoprost 0.03% (LATISSE®)
245986|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
245987|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
245988|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
245989|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
245990|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
245991|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
245992|NCT01229423|E1|Reported Event|LATISSE®|bimatoprost 0.03% (LATISSE®)
245993|NCT01229410|B3|Baseline|Total|Total of all reporting groups
245994|NCT01229410|B2|Baseline|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
245995|NCT01229410|B1|Baseline|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
245996|NCT01229410|P2|Participant Flow|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
245997|NCT01229410|P1|Participant Flow|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
245998|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
245999|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
246000|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
246001|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
246002|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
246003|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
246004|NCT01229410|E2|Reported Event|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
246005|NCT01229410|E1|Reported Event|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
246006|NCT01229397|B3|Baseline|Total|Total of all reporting groups
246007|NCT01229397|B2|Baseline|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
246008|NCT01229397|B1|Baseline|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
246009|NCT01229397|P2|Participant Flow|Inflexal V 0.5 mL x 1|"1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 mL dose:
15 μg HA antigen of A/California/7/2009 (H1N1)-like virus
15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
15 μg HA antigen of B/Brisbane/60/2008-like virus"
246010|NCT01229397|P1|Participant Flow|Inflexal V 0.25 mL x 2|"2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 mL dose:
7.5 μg HA antigen of A/California/7/2009 (H1N1)-like virus
7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
7.5 μg HA antigen of B/Brisbane/60/2008-like virus"
246011|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
246012|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
246075|NCT01229176|B7|Baseline|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
246076|NCT01229176|B6|Baseline|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
246077|NCT01229176|B5|Baseline|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246078|NCT01229176|B4|Baseline|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
246079|NCT01229176|B3|Baseline|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246080|NCT01229176|B2|Baseline|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
246081|NCT01229176|B1|Baseline|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
246082|NCT01229176|P8|Participant Flow|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
246083|NCT01229176|P7|Participant Flow|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
246084|NCT01229176|P6|Participant Flow|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
246085|NCT01229176|P5|Participant Flow|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246086|NCT01229176|P4|Participant Flow|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
246087|NCT01229176|P3|Participant Flow|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246088|NCT01229176|P2|Participant Flow|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
246089|NCT01229176|P1|Participant Flow|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
246090|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
246091|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
246092|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
246093|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246094|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
246095|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246096|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
246097|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
246098|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
246099|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
246100|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
246101|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246102|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
246103|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246104|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
246105|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
246106|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
246107|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
246108|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
246109|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246110|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
246111|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246112|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
246113|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
246114|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
246115|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
246116|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
246117|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246118|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
246119|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246120|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
246121|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
246122|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
246123|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
246124|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
246125|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246291|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn.
246126|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
246127|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246128|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
246129|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
246130|NCT01229176|E8|Reported Event|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
246131|NCT01229176|E7|Reported Event|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
246132|NCT01229176|E6|Reported Event|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
246133|NCT01229176|E5|Reported Event|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246134|NCT01229176|E4|Reported Event|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
246135|NCT01229176|E3|Reported Event|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
246136|NCT01229176|E2|Reported Event|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
246137|NCT01229176|E1|Reported Event|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
246138|NCT01229150|B5|Baseline|Total|Total of all reporting groups
246139|NCT01229150|B4|Baseline|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246140|NCT01229150|B3|Baseline|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
246141|NCT01229150|B2|Baseline|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246142|NCT01229150|B1|Baseline|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246143|NCT01229150|P4|Participant Flow|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246144|NCT01229150|P3|Participant Flow|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
246145|NCT01229150|P2|Participant Flow|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246146|NCT01229150|P1|Participant Flow|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246147|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246148|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
246149|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246150|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246151|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erl (erlotinib) mg qd."
246152|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd (every day)"
246153|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246154|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erl (erlotinib) mg qd."
246155|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246156|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
246157|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246158|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246159|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246160|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246161|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246162|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246163|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246164|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246165|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246166|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246167|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246168|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246169|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246170|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246171|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246172|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
246173|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246174|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246175|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246176|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246177|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246178|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246179|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246180|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246181|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
246182|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246183|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246184|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246185|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
246186|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246187|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246188|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
246189|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246190|NCT01229150|O1|Outcome|KRAS Mut 2 & WT KRAS 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS 2 patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246191|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246192|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
246193|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246194|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246195|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
246196|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
246197|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246198|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246199|NCT01229150|E3|Reported Event|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm
Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
246200|NCT01229150|E2|Reported Event|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm
AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
246201|NCT01229150|E1|Reported Event|KRAS Mut 2 & WT KRAS 2|"KRAS Mutant patients randomized to combination therapy arm
AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS 2 patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
246202|NCT01229111|B1|Baseline|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
cediranib maleate: Given PO
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
246203|NCT01229111|P1|Participant Flow|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
cediranib maleate: Given PO
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
246204|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
cediranib maleate: Given PO
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
246205|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
cediranib maleate: Given PO
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
246206|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
cediranib maleate: Given PO
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
246207|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
cediranib maleate: Given PO
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
246208|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
cediranib maleate: Given PO
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
246209|NCT01229111|E1|Reported Event|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
cediranib maleate: Given PO
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
246210|NCT01228968|B1|Baseline|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
246211|NCT01228968|P1|Participant Flow|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
246212|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
246253|NCT01228747|P1|Participant Flow|Placebo|"Matching placebo for 28 weeks
Placebo: Matching oral placebo tablets twice daily for 28 weeks"
246213|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
246214|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
246215|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
246216|NCT01228968|E1|Reported Event|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
246217|NCT01228929|B4|Baseline|Total|Total of all reporting groups
246218|NCT01228929|B3|Baseline|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
246219|NCT01228929|B2|Baseline|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
246220|NCT01228929|B1|Baseline|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
246221|NCT01228929|P3|Participant Flow|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
246222|NCT01228929|P2|Participant Flow|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
246223|NCT01228929|P1|Participant Flow|Normal|Subjects with no clinical diagnosis or symptoms of dry eye. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
246224|NCT01228929|O3|Outcome|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
246225|NCT01228929|O2|Outcome|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
246226|NCT01228929|O1|Outcome|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
246227|NCT01228929|E3|Reported Event|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
246228|NCT01228929|E2|Reported Event|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
246229|NCT01228929|E1|Reported Event|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
246230|NCT01228903|B3|Baseline|Total|Total of all reporting groups
246231|NCT01228903|B2|Baseline|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.
Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
246232|NCT01228903|B1|Baseline|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.
Placebo: Placebo tablets with no active ingredient"
246233|NCT01228903|P2|Participant Flow|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.
Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
246234|NCT01228903|P1|Participant Flow|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.
Placebo: Placebo tablets with no active ingredient"
246235|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
246236|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
246237|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
246238|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
246239|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
246240|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
246241|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
246242|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
246243|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
246244|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
246245|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
246246|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
246247|NCT01228903|E2|Reported Event|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.
Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
246248|NCT01228903|E1|Reported Event|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.
Placebo: Placebo tablets with no active ingredient"
246249|NCT01228747|B3|Baseline|Total|Total of all reporting groups
246250|NCT01228747|B2|Baseline|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Levetiracetam: Oral dose tablets, twice daily"
246251|NCT01228747|B1|Baseline|Placebo|"Matching placebo for 28 weeks
Placebo: Matching oral placebo tablets twice daily"
246252|NCT01228747|P2|Participant Flow|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Levetiracetam: Oral dose tablets, twice daily"
246254|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Levetiracetam: Oral dose tablets, twice daily"
246255|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks
Placebo: Matching oral placebo tablets twice daily for 28 weeks"
246256|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Levetiracetam: Oral dose tablets, twice daily"
246257|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks
Placebo: Matching oral placebo tablets twice daily for 28 weeks"
246258|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Levetiracetam: Oral dose tablets, twice daily"
246259|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks
Placebo: Matching oral placebo tablets twice daily for 28 weeks"
246260|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Levetiracetam: Oral dose tablets, twice daily"
246261|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks
Placebo: Matching oral placebo tablets twice daily for 28 weeks"
246262|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Levetiracetam: Oral dose tablets, twice daily"
246263|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks
Placebo: Matching oral placebo tablets twice daily for 28 weeks"
246264|NCT01228747|E2|Reported Event|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Levetiracetam: Oral dose tablets, twice daily"
246265|NCT01228747|E1|Reported Event|Placebo|"Matching placebo for 28 weeks
Placebo: Matching oral placebo tablets twice daily for 28 weeks"
246266|NCT01228734|B3|Baseline|Total|Total of all reporting groups
246267|NCT01228734|B2|Baseline|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246268|NCT01228734|B1|Baseline|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246269|NCT01228734|P2|Participant Flow|FOLFOX4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246270|NCT01228734|P1|Participant Flow|Cetuximab + FOLFOX4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-fluorouracil (5-FU)/folinic acid (FA). Cetuximab was always administered every 7 days with an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246271|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246272|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246273|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246288|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
246289|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
246274|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246275|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246276|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246277|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246278|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246279|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246280|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246281|NCT01228734|E2|Reported Event|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246282|NCT01228734|E1|Reported Event|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
246283|NCT01228591|B1|Baseline|All Subjects|Subjects who were randomized and successfully completed the study.
246284|NCT01228591|P2|Participant Flow|Acuvue Advance/ Acuvue Advance Plus|Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
246285|NCT01228591|P1|Participant Flow|Acuvue Advance Plus/ Acuvue Advance|Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
246286|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
246287|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
246293|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn.
246294|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
246295|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
246296|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses - Binocular Measurements
246297|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses-Binocular measurements
246298|NCT01228591|E2|Reported Event|Acuvue Advance|Acuvue Advance contact lenses
246299|NCT01228591|E1|Reported Event|Acuvue Advance Plus|Acuvue Advance Plus contact lenses
246300|NCT01228435|B3|Baseline|Total|Total of all reporting groups
246301|NCT01228435|B2|Baseline|ALK-inhibitor Pre-treated|Prior exposure to ALK inhibitor
246302|NCT01228435|B1|Baseline|ALK-inhibitor Naive|No prior exposure to ALK-inhibitor
246303|NCT01228435|P2|Participant Flow|ALK-inhibitor Pre-treated|Patients in this arm had prior exposure to an ALK inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days.
246304|NCT01228435|P1|Participant Flow|ALK-inhibitor Naive|Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days.
246305|NCT01228435|O2|Outcome|ALK-inhibitor Pre-treated|Patients in this arm had receieved prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
246306|NCT01228435|O1|Outcome|ALK-inhibitor Naive|Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
246307|NCT01228435|E2|Reported Event|ALK-inhibitor Pre-treated|Prior exposure to ALK inhibitor
246308|NCT01228435|E1|Reported Event|ALK-inhibitor Naive|No prior exposure to ALK-inhibitor
246309|NCT01228175|B3|Baseline|Total|Total of all reporting groups
246310|NCT01228175|B2|Baseline|Microcrystal Cellulose|"Microcrystal cellulose placebo
Placebo: 25mg look alike riboflavin tablets to match active study medication."
246311|NCT01228175|B1|Baseline|Varenicline|"Varenicline
Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
246312|NCT01228175|P2|Participant Flow|Microcrystal Cellulose|"Microcrystal cellulose placebo
Placebo: 25mg look alike riboflavin tablets to match active study medication."
246313|NCT01228175|P1|Participant Flow|Varenicline|"Varenicline
Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
246314|NCT01228175|O2|Outcome|Microcrystal Cellulose|"Microcrystal cellulose placebo
Placebo: 25mg look alike riboflavin tablets to match active study medication."
246315|NCT01228175|O1|Outcome|Varenicline|"Varenicline
Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
246316|NCT01228175|E2|Reported Event|Microcrystal Cellulose|"Microcrystal cellulose placebo
Placebo: 25mg look alike riboflavin tablets to match active study medication."
246317|NCT01228175|E1|Reported Event|Varenicline|"Varenicline
Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
246318|NCT01228149|B3|Baseline|Total|Total of all reporting groups
246319|NCT01228149|B2|Baseline|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246320|NCT01228149|B1|Baseline|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246321|NCT01228149|P2|Participant Flow|Cosopt S|"Patients receive Cosopt S eye drops starting 28 days preoperatively
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246322|NCT01228149|P1|Participant Flow|Diamox/DexaEDO|"Patients receive oral acetazolamide starting 28 days preoperatively. 7 days preoperatively dexamethasone eyedrops without preservatives are applied additionally.
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246323|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.
Trabeculectomy with preoperative Cosopt S treatment: Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery."
246324|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days Prior to trabeculectomy. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Patient will undergo trabeculectomy.
Trabeculectomy with preoperative Diamox/DexaEDO treatment: Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery"
246325|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246326|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246327|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246328|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246329|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246330|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
300768|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
246331|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246332|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246333|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246334|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246335|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246336|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246337|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.
Trabeculectomy with preoperative Cosopt S treatment: Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery."
246338|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days Prior to trabeculectomy. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Patient will undergo trabeculectomy.
Trabeculectomy with preoperative Diamox/DexaEDO treatment: Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery"
246339|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246340|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive oral Diamox (acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246341|NCT01228149|E2|Reported Event|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246342|NCT01228149|E1|Reported Event|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.
Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
246343|NCT01228084|B1|Baseline|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
246344|NCT01228084|P1|Participant Flow|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
246345|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
246346|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
246347|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
246348|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
246349|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
246350|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
246351|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
246352|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
246353|NCT01228084|E1|Reported Event|Sulpforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic
246354|NCT01228071|B1|Baseline|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%
testosterone gel 2% : 40 mg testosterone gel 2%"
246355|NCT01228071|P1|Participant Flow|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%
testosterone gel 2% : 40 mg testosterone gel 2%"
246356|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%
testosterone gel 2% : 40 mg testosterone gel 2%"
246357|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%
testosterone gel 2% : 40 mg testosterone gel 2%"
290562|NCT00117559|B2|Baseline|Treatment as Usual|Control group
246358|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%
testosterone gel 2% : 40 mg testosterone gel 2%"
246359|NCT01228071|E1|Reported Event|EN3350 (Testosterone Gel 2%)|"testosterone gel 2%
testosterone gel 2% : 40 mg testosterone gel 2%"
246360|NCT01228019|B1|Baseline|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246361|NCT01228019|P1|Participant Flow|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246362|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246363|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246364|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246365|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246366|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246367|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246368|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246369|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246370|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246371|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246372|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246373|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
246374|NCT01228019|E1|Reported Event|ALL PARTICIPANTS|
246375|NCT01227993|B1|Baseline|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
246376|NCT01227993|P1|Participant Flow|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
246377|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
246378|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
246379|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
246380|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
246381|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
246382|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
246383|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
246384|NCT01227993|E1|Reported Event|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
246385|NCT01227980|B3|Baseline|Total|Total of all reporting groups
246386|NCT01227980|B2|Baseline|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246387|NCT01227980|B1|Baseline|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246388|NCT01227980|P2|Participant Flow|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246389|NCT01227980|P1|Participant Flow|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246390|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246391|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246392|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246393|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246394|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246395|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246396|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246397|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246398|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246399|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246400|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246401|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246402|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246403|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246404|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246405|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246406|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246407|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246408|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246409|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246410|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246411|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246412|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246413|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246414|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246415|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246416|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246417|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246418|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246419|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246420|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246421|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246422|NCT01227980|E2|Reported Event|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
246423|NCT01227980|E1|Reported Event|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
246424|NCT01227967|B3|Baseline|Total|Total of all reporting groups
246425|NCT01227967|B2|Baseline|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246426|NCT01227967|B1|Baseline|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246427|NCT01227967|P2|Participant Flow|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246428|NCT01227967|P1|Participant Flow|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246429|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246430|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246431|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246432|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246433|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246827|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246434|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246435|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246436|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246437|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246438|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246439|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246440|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246441|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246442|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246443|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246444|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246445|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246446|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246447|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246448|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246449|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246450|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246451|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246452|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246453|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246454|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246455|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246456|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246457|NCT01227967|O2|Outcome|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246458|NCT01227967|O1|Outcome|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246459|NCT01227967|E2|Reported Event|Oseltamivir Monotherapy|"Drug: Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg."
246460|NCT01227967|E1|Reported Event|Combination Therapy|"Drug: Amantadine, Ribavirin, Oseltamivir
Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg."
246461|NCT01227928|B3|Baseline|Total|Total of all reporting groups
246462|NCT01227928|B2|Baseline|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246463|NCT01227928|B1|Baseline|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246464|NCT01227928|P2|Participant Flow|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246465|NCT01227928|P1|Participant Flow|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246466|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246467|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246468|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246469|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246470|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246471|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246472|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246473|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246474|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246475|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246476|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246477|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246478|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246479|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246480|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246481|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246482|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246483|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246484|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246485|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246486|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246487|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246488|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246489|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246490|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246491|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246492|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246493|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246494|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246495|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246496|NCT01227928|E2|Reported Event|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
246497|NCT01227928|E1|Reported Event|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
246498|NCT01227902|B5|Baseline|Total|Total of all reporting groups
246499|NCT01227902|B4|Baseline|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246500|NCT01227902|B3|Baseline|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246501|NCT01227902|B2|Baseline|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246646|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246828|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246502|NCT01227902|B1|Baseline|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246503|NCT01227902|P4|Participant Flow|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246504|NCT01227902|P3|Participant Flow|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246505|NCT01227902|P2|Participant Flow|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246506|NCT01227902|P1|Participant Flow|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246507|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246508|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246509|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246510|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246511|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246512|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246513|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246514|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246647|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246834|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246515|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246516|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246517|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246518|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246519|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246520|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246521|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246522|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246523|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246524|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246525|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246526|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246527|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246528|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246648|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246829|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246830|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246529|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246530|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246531|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246532|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246533|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246534|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246535|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246536|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246537|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246538|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246539|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246540|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246541|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246542|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246649|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246543|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246544|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246545|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246546|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246547|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246548|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246549|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246550|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246551|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246552|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246553|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246554|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246555|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246570|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246556|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246557|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246558|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246559|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246560|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246561|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246562|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246563|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246564|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246565|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246566|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246567|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246568|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246569|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246643|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246571|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246572|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246573|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246574|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246575|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246576|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246577|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246578|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246579|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246580|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246581|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246582|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246583|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246584|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246644|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246650|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246585|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246586|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246587|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
246588|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246589|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246590|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246591|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246592|NCT01227902|E4|Reported Event|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246593|NCT01227902|E3|Reported Event|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246594|NCT01227902|E2|Reported Event|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246595|NCT01227902|E1|Reported Event|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
246596|NCT01227889|B3|Baseline|Total|Total of all reporting groups
246597|NCT01227889|B2|Baseline|DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase|In the RP, par. received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy.
246831|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246598|NCT01227889|B1|Baseline|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246599|NCT01227889|P2|Participant Flow|DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase|In the RP, par. received intravenous (IV) Dacarbazine (DTIC) 1000 mg per meters squared (mg/m^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy.
246600|NCT01227889|P1|Participant Flow|GSK2118436 150 mg BID|Participants (par.) were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246601|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
246602|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246603|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
246604|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246605|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
246606|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
246607|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
246608|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246756|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole (ARP) at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
246609|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
246610|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
246611|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246612|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
246613|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246614|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
246615|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246616|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
246617|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease DP, death, the occurrence of an unacceptable adverse AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246618|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
246619|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246620|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received intravenous (IV) Dacarbazine (DTIC) 1000 milligrams per meters squared (mg/m^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
246645|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246757|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
246621|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246622|NCT01227889|E3|Reported Event|GSK25118436 in the Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
246623|NCT01227889|E2|Reported Event|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
246624|NCT01227889|E1|Reported Event|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
246625|NCT01227824|B3|Baseline|Total|Total of all reporting groups
246626|NCT01227824|B2|Baseline|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246627|NCT01227824|B1|Baseline|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246628|NCT01227824|P2|Participant Flow|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246629|NCT01227824|P1|Participant Flow|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246630|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246631|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246632|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246633|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246634|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246635|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246636|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246637|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246638|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246639|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246640|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246641|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246642|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246651|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246652|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246653|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246654|NCT01227824|E2|Reported Event|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
246655|NCT01227824|E1|Reported Event|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
246656|NCT01227785|B1|Baseline|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
246657|NCT01227785|P1|Participant Flow|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
246658|NCT01227785|O1|Outcome|INCEPTA CRT-D and ICD (Overall Study Population)|
246659|NCT01227785|O2|Outcome|INCEPTA ICD|
246660|NCT01227785|O1|Outcome|INCEPTA CRT-D|
246661|NCT01227785|O2|Outcome|INCEPTA ICD|
246662|NCT01227785|O1|Outcome|INCEPTA CRT-D|
246663|NCT01227785|O2|Outcome|INCEPTA ICD|
246664|NCT01227785|O1|Outcome|INCEPTA CRT-D|
246665|NCT01227785|O2|Outcome|INCEPTA ICD|
246666|NCT01227785|O1|Outcome|INCEPTA CRT-D|
246667|NCT01227785|O2|Outcome|INCEPTA ICD|
246668|NCT01227785|O1|Outcome|INCEPTA CRT-D|
246669|NCT01227785|O2|Outcome|INCEPTA ICD|
246670|NCT01227785|O1|Outcome|INCEPTA CRT-D|
246671|NCT01227785|O2|Outcome|INCEPTA ICD|
246672|NCT01227785|O1|Outcome|INCEPTA CRT-D|
246673|NCT01227785|O1|Outcome|INCEPTA CRT-D and ICD Patients (Overall Study Population)|
246674|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246675|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246676|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246677|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246678|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246679|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246680|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246681|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246682|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246683|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246684|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246685|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246686|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246687|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246688|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246689|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246690|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246691|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246692|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246693|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246694|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246695|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246696|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246697|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246698|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246699|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246700|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246701|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246702|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246703|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246704|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246705|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246706|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246707|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246708|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246709|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246710|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246711|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246712|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246713|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246714|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
246715|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246716|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246717|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246718|NCT01227785|O2|Outcome|Group 2: Patients Without a HFE|Patients who did not experience a protocol-defined HFE
246719|NCT01227785|O1|Outcome|Group1: Patients With a HFE|Patients who experienced a protocol-defined HF event
246720|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
246721|NCT01227785|E1|Reported Event|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
246758|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
246759|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
246832|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246833|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246722|NCT01227707|B1|Baseline|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246723|NCT01227707|P1|Participant Flow|Bevacizumab (Bv)+Capecitabine/Bv+Leucovorin+5-fluorouracil|Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days -14, 1, 15, and 29 and capecitabine 825 milligrams per square meter (mg/m^2) orally (PO) twice daily (BID) from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gray (Gy) administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246724|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246725|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246726|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246727|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246728|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246729|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246730|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246731|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246824|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246825|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246732|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246733|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246734|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246735|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246736|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246737|NCT01227707|E1|Reported Event|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
246738|NCT01227681|B4|Baseline|Total|Total of all reporting groups
246739|NCT01227681|B3|Baseline|Placebo|normal saline 0.9% injection
246740|NCT01227681|B2|Baseline|Low Dose G-CSF Injection for Parkinson's Disease|1.65 ug/kg/day for consecutive 5 days of each 60 day cycle
246741|NCT01227681|B1|Baseline|High Dose G-CSF Injection for Parkinson's Disease|3.3 ug/kg/day for consecutive 5 days of each 60 day cycle
246742|NCT01227681|P3|Participant Flow|Placebo|subcutaneous Normal saline for consecutive 5 days of each 60 day cycle
246743|NCT01227681|P2|Participant Flow|Low Dose G-CSF|1.65ug/kg/day for consecutive 5 days of each 60 day cycle
246744|NCT01227681|P1|Participant Flow|G-CSF|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
246745|NCT01227681|O1|Outcome|G-CSF Injection for Parkinson's Disease|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
246746|NCT01227681|E1|Reported Event|G-CSF Injection for Parkinson's Disease|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
246747|NCT01227668|B3|Baseline|Total|Total of all reporting groups
246748|NCT01227668|B2|Baseline|Placebo|Phase 2: Participants received placebo for 16 weeks.
246749|NCT01227668|B1|Baseline|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
246750|NCT01227668|P2|Participant Flow|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
246751|NCT01227668|P1|Participant Flow|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|"Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.
Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability."
246752|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
246753|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
246754|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.
246755|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo (pb)for 16 weeks.
246826|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246760|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
246761|NCT01227668|E3|Reported Event|Placebo (Phase 2 Only)|Phase 2 only: Participants received placebo for 16 weeks.
246762|NCT01227668|E2|Reported Event|Aripiprazole, 2-15 mg (Phase 2)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
246763|NCT01227668|E1|Reported Event|Aripiprazole, 2-15 mg (Phase 1)|Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.
246764|NCT01227655|B4|Baseline|Total|Total of all reporting groups
246765|NCT01227655|B3|Baseline|Placebo|Placebo: comparator
246766|NCT01227655|B2|Baseline|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
246767|NCT01227655|B1|Baseline|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
246768|NCT01227655|P3|Participant Flow|Placebo|Placebo: comparator
246769|NCT01227655|P2|Participant Flow|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
246770|NCT01227655|P1|Participant Flow|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
246771|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
246772|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
246773|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
246774|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
246775|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
246776|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
246777|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
246778|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
246779|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
246780|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
246781|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
246782|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
246783|NCT01227655|E3|Reported Event|Placebo|Placebo: comparator
246784|NCT01227655|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
246785|NCT01227655|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
246786|NCT01227629|B11|Baseline|Total|Total of all reporting groups
246787|NCT01227629|B10|Baseline|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246788|NCT01227629|B9|Baseline|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246789|NCT01227629|B8|Baseline|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246790|NCT01227629|B7|Baseline|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246791|NCT01227629|B6|Baseline|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246792|NCT01227629|B5|Baseline|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246793|NCT01227629|B4|Baseline|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246794|NCT01227629|B3|Baseline|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246795|NCT01227629|B2|Baseline|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246796|NCT01227629|B1|Baseline|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246797|NCT01227629|P10|Participant Flow|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246798|NCT01227629|P9|Participant Flow|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246799|NCT01227629|P8|Participant Flow|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246800|NCT01227629|P7|Participant Flow|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246801|NCT01227629|P6|Participant Flow|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246802|NCT01227629|P5|Participant Flow|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246803|NCT01227629|P4|Participant Flow|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246804|NCT01227629|P3|Participant Flow|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246805|NCT01227629|P2|Participant Flow|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246806|NCT01227629|P1|Participant Flow|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246807|NCT01227629|O17|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|Warfarin once daily
246808|NCT01227629|O16|Outcome|D300qd + ASA325qd|Dabigatran 300 mg once daily + ASA 325 mg once daily
246809|NCT01227629|O15|Outcome|D300bid + ASA325qd|Dabigatran 300 mg twice daily + ASA 325 mg once daily
246810|NCT01227629|O14|Outcome|D300qd + ASA81qd|Dabigatran 300 mg once daily + ASA 81 mg once daily
246811|NCT01227629|O13|Outcome|D300bid + ASA81qd|Dabigatran 300 mg twice daily + ASA 81 mg once daily
246812|NCT01227629|O12|Outcome|D300qd|Dabigatran 300 mg once daily
246813|NCT01227629|O11|Outcome|D300bid|Dabigatran 300 mg twice daily
246814|NCT01227629|O10|Outcome|D150qd + ASA325qd|Dabigatran 150 mg once daily + ASA 325 mg once daily
246815|NCT01227629|O9|Outcome|D150bid + ASA325qd|Dabigatran 150 mg twice daily + ASA 325 mg once daily
246816|NCT01227629|O8|Outcome|D150qd + ASA81qd|Dabigatran 150 mg once daily + ASA 81 mg once daily
246817|NCT01227629|O7|Outcome|D150bid + ASA81qd|Dabigatran 150 mg twice daily + ASA 81 mg once daily
246818|NCT01227629|O6|Outcome|D150qd|Dabigatran 150 mg once daily
246819|NCT01227629|O5|Outcome|D150bid|Dabigatran 150 mg twice daily
246820|NCT01227629|O4|Outcome|D50bid + ASA325qd|Dabigatran 50 mg twice daily + ASA 325 mg once daily
246821|NCT01227629|O3|Outcome|D50bid + ASA81qd|Dabigatran 50 mg twice daily + ASA 81 mg once daily
246822|NCT01227629|O2|Outcome|D50qd|Dabigatran 50 mg once daily
246823|NCT01227629|O1|Outcome|D50bid|Dabigatran 50 mg twice daily
295273|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
246835|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246836|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246837|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246838|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246839|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246840|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246841|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246842|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246843|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246844|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246845|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246846|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246847|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246848|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246849|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246850|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246851|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246852|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246853|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246854|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246855|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246856|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246857|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246858|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246859|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246860|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246861|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246862|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246863|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246864|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246865|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246866|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246867|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246868|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246869|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246870|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246871|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246872|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246873|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246874|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246875|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246876|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246877|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246878|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246879|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246880|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246881|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246882|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246883|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246884|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246885|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246886|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246887|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246888|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246889|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246890|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246891|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246892|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246893|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246894|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246895|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246896|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246897|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
295921|NCT00141778|O1|Outcome|Placebo|Placebo Group
246898|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246899|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246900|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246901|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246902|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246903|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246904|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246905|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246906|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246907|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246908|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246909|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246910|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246911|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246912|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246913|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246914|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246915|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246916|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246917|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246918|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246919|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246920|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246921|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246922|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246923|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246924|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246925|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246926|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246927|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246928|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246929|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246930|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246931|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246932|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246933|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246934|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246935|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246936|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246937|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246938|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246939|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246940|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246941|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246942|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246943|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246944|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246945|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246946|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246947|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246948|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246949|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246950|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246951|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246952|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246953|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246954|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246955|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246956|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246957|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246958|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246959|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246960|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
296048|NCT00142415|B7|Baseline|Total|Total of all reporting groups
246961|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246962|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246963|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246964|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246965|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246966|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246967|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246968|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246969|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246970|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246971|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246972|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246973|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246974|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246975|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246976|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246977|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246978|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246979|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246980|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246981|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246982|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246983|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246984|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246985|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246986|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246987|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246988|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246989|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246990|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
246991|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246992|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
246993|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
246994|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
246995|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246996|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
246997|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
246998|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
246999|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
247000|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
247001|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
247002|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
247003|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
247004|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
247005|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
247006|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
247007|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
247008|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
247009|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
247010|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
247011|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
247012|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
247013|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
247014|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
247015|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
247016|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
247017|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
247018|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
247019|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
247020|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
247021|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
247022|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
247023|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
247024|NCT01227629|E17|Reported Event|Warfarin|Warfarin once daily
247025|NCT01227629|E16|Reported Event|D300qd + ASA325qd|Dabigatran 300 mg once daily + ASA 325 mg once daily
247026|NCT01227629|E15|Reported Event|D300bid + ASA325qd|Dabigatran 300 mg twice daily + ASA 325 mg once daily
247027|NCT01227629|E14|Reported Event|D300qd + ASA81qd|Dabigatran 300 mg once daily + ASA 81 mg once daily
247028|NCT01227629|E13|Reported Event|D300bid + ASA81qd|Dabigatran 300 mg twice daily + ASA 81 mg once daily
247029|NCT01227629|E12|Reported Event|D300qd|Dabigatran 300 mg once daily
247030|NCT01227629|E11|Reported Event|D300bid|Dabigatran 300 mg twice daily
247031|NCT01227629|E10|Reported Event|D150qd + ASA325qd|Dabigatran 150 mg once daily + ASA 325 mg once daily
247032|NCT01227629|E9|Reported Event|D150bid + ASA325qd|Dabigatran 150 mg twice daily + ASA 325 mg once daily
247033|NCT01227629|E8|Reported Event|D150qd + ASA81qd|Dabigatran 150 mg once daily + ASA 81 mg once daily
247034|NCT01227629|E7|Reported Event|D150bid + ASA81qd|Dabigatran 150 mg twice daily + ASA 81 mg once daily
247035|NCT01227629|E6|Reported Event|D150qd|Dabigatran 150 mg once daily
247036|NCT01227629|E5|Reported Event|D150bid|Dabigatran 150 mg twice daily
247037|NCT01227629|E4|Reported Event|D50bid + ASA325qd|Dabigatran 50 mg twice daily + ASA 325 mg once daily
247038|NCT01227629|E3|Reported Event|D50bid + ASA81qd|Dabigatran 50 mg twice daily + ASA 81 mg once daily
247039|NCT01227629|E2|Reported Event|D50qd|Dabigatran 50 mg once daily
247040|NCT01227629|E1|Reported Event|D50bid|Dabigatran 50 mg twice daily
247041|NCT01227577|B1|Baseline|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247042|NCT01227577|P1|Participant Flow|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247043|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247044|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247045|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247046|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247047|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247048|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247049|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247050|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247051|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247052|NCT01227577|E1|Reported Event|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
247053|NCT01227564|B4|Baseline|Total|Total of all reporting groups
247054|NCT01227564|B3|Baseline|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247055|NCT01227564|B2|Baseline|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247056|NCT01227564|B1|Baseline|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247057|NCT01227564|P3|Participant Flow|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247058|NCT01227564|P2|Participant Flow|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247059|NCT01227564|P1|Participant Flow|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247060|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247061|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247062|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247063|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247064|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247065|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247066|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247067|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247274|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247068|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247069|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247070|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247071|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247072|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247073|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247074|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247075|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247076|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247077|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247078|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247079|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247080|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247081|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247082|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247083|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247084|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247085|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247086|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247087|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247088|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247089|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247090|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247091|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247092|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247093|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247094|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247095|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247096|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247097|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247098|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247130|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247099|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247100|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247101|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247102|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247103|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247104|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247105|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247106|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247107|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247108|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247109|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247110|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247111|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247112|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247113|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247114|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247115|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247116|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247117|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247118|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247119|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247120|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247121|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247122|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247123|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247124|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247125|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247126|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247127|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247128|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247129|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247131|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247132|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247133|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247134|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247135|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247136|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247137|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247138|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247139|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247140|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247141|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247142|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247143|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247144|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247145|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247146|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247147|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247148|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247149|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247150|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247151|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247152|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247153|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247154|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247155|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247156|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247157|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247158|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247159|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247160|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247161|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247162|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247163|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247164|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247165|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247166|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247167|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247168|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247169|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247170|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247171|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247172|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247173|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247174|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247175|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247176|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247177|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247178|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247179|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247180|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247181|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247182|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247183|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247184|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247185|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247186|NCT01227564|E3|Reported Event|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247187|NCT01227564|E2|Reported Event|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247188|NCT01227564|E1|Reported Event|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
247189|NCT01227551|B1|Baseline|CVA21|CVA21 monotherapy
247190|NCT01227551|P1|Participant Flow|CVA21|CVA21 monotherapy
247191|NCT01227551|O1|Outcome|CVA21|CVA21 monotherapy
247192|NCT01227551|O1|Outcome|CVA21|CVA21 monotherapy
247193|NCT01227551|E1|Reported Event|CVA21|CVA21 monotherapy
247194|NCT01227512|B3|Baseline|Total|Total of all reporting groups
247270|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247195|NCT01227512|B2|Baseline|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
247196|NCT01227512|B1|Baseline|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
247197|NCT01227512|P2|Participant Flow|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
247198|NCT01227512|P1|Participant Flow|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
247199|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
247200|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
247201|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
247202|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
247203|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
247204|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
247205|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may titrated based on serum sodium response.
247206|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
247207|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
247208|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
247209|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
247210|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
247211|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction be may titrated based on serum sodium response.
247212|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
247213|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
247214|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
247215|NCT01227512|E2|Reported Event|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
247216|NCT01227512|E1|Reported Event|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
247217|NCT01227434|B3|Baseline|Total|Total of all reporting groups
247218|NCT01227434|B2|Baseline|Non-surgical Group|Patients not in need of surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
247219|NCT01227434|B1|Baseline|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
247220|NCT01227434|P2|Participant Flow|Non-surgical Group|Patients not in need of surgery treated with PD 0332991 at a dose of 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
247221|NCT01227434|P1|Participant Flow|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, surgical resection for progression, and resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
247222|NCT01227434|O2|Outcome|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
247271|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247272|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247273|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247223|NCT01227434|O1|Outcome|Surgical Group|PD 0332991 at a dose of 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
247224|NCT01227434|O2|Outcome|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
247225|NCT01227434|O1|Outcome|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
247226|NCT01227434|E2|Reported Event|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
247227|NCT01227434|E1|Reported Event|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
247228|NCT01227421|B4|Baseline|Total|Total of all reporting groups
247229|NCT01227421|B3|Baseline|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247230|NCT01227421|B2|Baseline|Placebo|placebo tablet twice daily with food for 5 days
247231|NCT01227421|B1|Baseline|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247232|NCT01227421|P3|Participant Flow|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247233|NCT01227421|P2|Participant Flow|Placebo|placebo tablet twice daily with food for 5 days
247234|NCT01227421|P1|Participant Flow|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247235|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247236|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247237|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247238|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247239|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247240|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247241|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247242|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247243|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247244|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247245|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247246|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247247|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247248|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247249|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247250|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247251|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247252|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247253|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247254|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247255|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247256|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247257|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247258|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247259|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247260|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247261|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247262|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247263|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247264|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247265|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247266|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247267|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247268|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247269|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247275|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247276|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247277|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247278|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
247279|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247280|NCT01227421|E3|Reported Event|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
247281|NCT01227421|E2|Reported Event|Placebo|placebo tablet twice daily with food for 5 days
247282|NCT01227421|E1|Reported Event|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
247283|NCT01227395|B3|Baseline|Total|Total of all reporting groups
247284|NCT01227395|B2|Baseline|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
247285|NCT01227395|B1|Baseline|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247286|NCT01227395|P2|Participant Flow|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
247287|NCT01227395|P1|Participant Flow|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247288|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247289|NCT01227395|O1|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
247290|NCT01227395|O2|Outcome|Azithromycin Without Allergies|Participants without allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
247291|NCT01227395|O1|Outcome|Azithromycin With Allergies|Participants with allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
247292|NCT01227395|O2|Outcome|Azithromycin Without Renal Dysfunction|Participants without renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
247293|NCT01227395|O1|Outcome|Azithromycin With Renal Dysfunction|Participants with renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
247294|NCT01227395|O2|Outcome|Female|Female Participants taking Azithromycin for Treatment according to Japanese Package Insert.
247295|NCT01227395|O1|Outcome|Male|Male Participants taking Azithromycin for Treatment according to Japanese Package Insert.
247296|NCT01227395|O2|Outcome|>=65 Years|Participants with >=65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
247297|NCT01227395|O1|Outcome|<65 Years|Participants with <65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
247298|NCT01227395|O2|Outcome|Azithromycin Without Allergies|Participants without allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247299|NCT01227395|O1|Outcome|Azithromycin With Allergies|Participants with allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247300|NCT01227395|O2|Outcome|Azithromycin Without Renal Dysfunction|Participants without renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247301|NCT01227395|O1|Outcome|Azithromycin With Renal Dysfunction|Participants with renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247302|NCT01227395|O2|Outcome|Azithromycin Without Concomitant Drugs|Participants without concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247303|NCT01227395|O1|Outcome|Azithromycin With Concomitant Drugs|Participants with concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247304|NCT01227395|O2|Outcome|Female|Female Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247305|NCT01227395|O1|Outcome|Male|Male Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247306|NCT01227395|O2|Outcome|>=65 Years|Participants with >=65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247307|NCT01227395|O1|Outcome|<65 Years|Participants with <65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247308|NCT01227395|O2|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
247309|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247310|NCT01227395|O2|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
247311|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247312|NCT01227395|E2|Reported Event|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
247313|NCT01227395|E1|Reported Event|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
247314|NCT01227382|B1|Baseline|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
247315|NCT01227382|P1|Participant Flow|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
247316|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
247317|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
247318|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
296809|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
247319|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
247320|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
247321|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
247322|NCT01227382|O1|Outcome|Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
247323|NCT01227382|E1|Reported Event|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
247324|NCT01227278|B3|Baseline|Total|Total of all reporting groups
247325|NCT01227278|B2|Baseline|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247326|NCT01227278|B1|Baseline|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247327|NCT01227278|P2|Participant Flow|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247328|NCT01227278|P1|Participant Flow|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247329|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247330|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247331|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247332|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247333|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247334|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247335|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247336|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247337|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247338|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247339|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247340|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247341|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247342|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247343|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247344|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247345|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247346|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247347|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247348|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247349|NCT01227278|E2|Reported Event|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247350|NCT01227278|E1|Reported Event|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
247351|NCT01227265|B4|Baseline|Total|Total of all reporting groups
247352|NCT01227265|B3|Baseline|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
247353|NCT01227265|B2|Baseline|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247354|NCT01227265|B1|Baseline|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247355|NCT01227265|P3|Participant Flow|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
247356|NCT01227265|P2|Participant Flow|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247357|NCT01227265|P1|Participant Flow|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247358|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
247359|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247360|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247361|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
247362|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247363|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247364|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
247365|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247366|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247367|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
247368|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247369|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247370|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
247371|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247372|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247373|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
247374|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247375|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247376|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
247377|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247378|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247379|NCT01227265|E3|Reported Event|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
247380|NCT01227265|E2|Reported Event|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247381|NCT01227265|E1|Reported Event|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
247382|NCT01227057|B3|Baseline|Total|Total of all reporting groups
247383|NCT01227057|B2|Baseline|Arm 2: Case Management|Case Management: Case management
247384|NCT01227057|B1|Baseline|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding
Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
247385|NCT01227057|P2|Participant Flow|Arm 2: Case Management|Case Management: Case management
247386|NCT01227057|P1|Participant Flow|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding
Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
247387|NCT01227057|O2|Outcome|Arm 2: Case Management|"Case management
Case Management: Case management"
247388|NCT01227057|O1|Outcome|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding
Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
247389|NCT01227057|O2|Outcome|Arm 2: Case Management|Case Management: Case management
247390|NCT01227057|O1|Outcome|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding
Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
247391|NCT01227057|E2|Reported Event|Arm 2: Case Management|Case Management: Case management
247392|NCT01227057|E1|Reported Event|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding
Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
247393|NCT01227018|B1|Baseline|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
247394|NCT01227018|P1|Participant Flow|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
247395|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
247396|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
247397|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
247398|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
247399|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
247400|NCT01227018|E1|Reported Event|STA-9090|175 mg/m2 STA-9090 IV over 1 hour once a week for 3 weeks, followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression.
247401|NCT01227005|B3|Baseline|Total|Total of all reporting groups
247402|NCT01227005|B2|Baseline|Component Therapy|"Red blood cells, plasma, platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
247403|NCT01227005|B1|Baseline|Whole Blood|"Whole Blood plus pooled platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
247404|NCT01227005|P2|Participant Flow|Component Therapy|"Red blood cells, plasma, platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
247405|NCT01227005|P1|Participant Flow|Whole Blood|"Whole Blood plus pooled platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
247406|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
247407|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
247408|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
247409|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
296885|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
247410|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
247411|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
247412|NCT01227005|E2|Reported Event|Component Therapy|"Red blood cells, plasma, platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
247413|NCT01227005|E1|Reported Event|Whole Blood|"Whole Blood plus pooled platelets
Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
247414|NCT01226745|B7|Baseline|Total|Total of all reporting groups
247415|NCT01226745|B6|Baseline|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247416|NCT01226745|B5|Baseline|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247417|NCT01226745|B4|Baseline|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247418|NCT01226745|B3|Baseline|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247419|NCT01226745|B2|Baseline|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247420|NCT01226745|B1|Baseline|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247421|NCT01226745|P6|Participant Flow|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247422|NCT01226745|P5|Participant Flow|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247423|NCT01226745|P4|Participant Flow|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247424|NCT01226745|P3|Participant Flow|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247425|NCT01226745|P2|Participant Flow|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247426|NCT01226745|P1|Participant Flow|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247427|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247428|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247429|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247430|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247431|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247432|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247433|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247434|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247435|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247436|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247437|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247438|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247439|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247440|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247441|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247442|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247443|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247444|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247445|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247446|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247447|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247448|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247449|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247450|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247451|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247452|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247453|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247454|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247455|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247456|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247457|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247458|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247459|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247460|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247461|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247462|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247463|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247464|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247465|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247466|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247467|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247468|NCT01226745|O1|Outcome|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247469|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247470|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247471|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247472|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247473|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247474|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247475|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247476|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247477|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247478|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247479|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247480|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247481|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247482|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247483|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247484|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247485|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247486|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247487|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247488|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247489|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247490|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247491|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247492|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247493|NCT01226745|E6|Reported Event|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247494|NCT01226745|E5|Reported Event|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247495|NCT01226745|E4|Reported Event|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247496|NCT01226745|E3|Reported Event|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
247497|NCT01226745|E2|Reported Event|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
247498|NCT01226745|E1|Reported Event|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
247499|NCT01226732|B7|Baseline|Total|Total of all reporting groups
247500|NCT01226732|B6|Baseline|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247501|NCT01226732|B5|Baseline|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247502|NCT01226732|B4|Baseline|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247503|NCT01226732|B3|Baseline|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247504|NCT01226732|B2|Baseline|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247505|NCT01226732|B1|Baseline|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247506|NCT01226732|P6|Participant Flow|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247507|NCT01226732|P5|Participant Flow|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247508|NCT01226732|P4|Participant Flow|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247509|NCT01226732|P3|Participant Flow|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247510|NCT01226732|P2|Participant Flow|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247511|NCT01226732|P1|Participant Flow|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247512|NCT01226732|O1|Outcome|All Patients|The Response Rate is determined for all patients
247513|NCT01226732|O6|Outcome|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247514|NCT01226732|O5|Outcome|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247515|NCT01226732|O4|Outcome|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247516|NCT01226732|O3|Outcome|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247517|NCT01226732|O2|Outcome|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247518|NCT01226732|O1|Outcome|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247519|NCT01226732|O1|Outcome|All Patients|The Maximum Tolerated Dose (MTD) is determined for all patients
247520|NCT01226732|E6|Reported Event|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247521|NCT01226732|E5|Reported Event|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247522|NCT01226732|E4|Reported Event|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247523|NCT01226732|E3|Reported Event|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247524|NCT01226732|E2|Reported Event|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247525|NCT01226732|E1|Reported Event|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
247526|NCT01226719|B1|Baseline|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:
Panitumumab
Oxaliplatin
Irinotecan
Leucovorin
5-Fluorouracil
Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks
Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks
Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks
Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks
5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
247527|NCT01226719|P1|Participant Flow|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:
Panitumumab
Oxaliplatin
Irinotecan
Leucovorin
5-Fluorouracil
Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks
Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks
Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks
Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks
5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
247528|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:
Panitumumab
Oxaliplatin
Irinotecan
Leucovorin
5-Fluorouracil
Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks
Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks
Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks
Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks
5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
247529|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:
Panitumumab
Oxaliplatin
Irinotecan
Leucovorin
5-Fluorouracil
Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks
Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks
Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks
Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks
5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
247530|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:
Panitumumab
Oxaliplatin
Irinotecan
Leucovorin
5-Fluorouracil
Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks
Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks
Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks
Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks
5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
247531|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:
Panitumumab
Oxaliplatin
Irinotecan
Leucovorin
5-Fluorouracil
Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks
Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks
Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks
Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks
5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
247532|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:
Panitumumab
Oxaliplatin
Irinotecan
Leucovorin
5-Fluorouracil
Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks
Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks
Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks
Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks
5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
247533|NCT01226719|E1|Reported Event|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:
Panitumumab
Oxaliplatin
Irinotecan
Leucovorin
5-Fluorouracil
Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks
Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks
Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks
Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks
5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
247534|NCT01226706|B3|Baseline|Total|Total of all reporting groups
247535|NCT01226706|B2|Baseline|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247536|NCT01226706|B1|Baseline|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247537|NCT01226706|P2|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247538|NCT01226706|P1|Participant Flow|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247539|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247540|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247541|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247542|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247543|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247544|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247545|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247546|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247547|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247548|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247549|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247550|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247551|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247552|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247553|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247554|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247555|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247556|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247557|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247558|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247559|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247560|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247561|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247562|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247563|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247564|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247565|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247566|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247567|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247568|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247569|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247570|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247571|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247572|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
297709|NCT00140244|E2|Reported Event|Placebo|
247573|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247574|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247575|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247576|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247577|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247578|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247579|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247580|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247581|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247582|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247583|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247584|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247585|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247586|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247587|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247588|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247589|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247590|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247591|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247592|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247593|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247594|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247595|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247596|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247597|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247598|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247599|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247600|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247601|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247602|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247603|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247730|NCT01226043|O2|Outcome|Vial and Syringe|Patients using Vial and Syringe during the re-randomization phase.
247925|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247604|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247605|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247606|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247607|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247608|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247609|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247610|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247611|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247612|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247613|NCT01226706|O2|Outcome|Botulinum Toxin Type A|"Botulinum toxin Type A 100U injected into the detrusor at Day 1
botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1"
247614|NCT01226706|O1|Outcome|Placebo|"Placebo injected into the detrusor at Day 1,
Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified."
247615|NCT01226706|O2|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247616|NCT01226706|O1|Outcome|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247617|NCT01226706|E2|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247618|NCT01226706|E1|Reported Event|Placebo|normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
247619|NCT01226511|B3|Baseline|Total|Total of all reporting groups
247620|NCT01226511|B2|Baseline|Placebo/Duloxetine|"Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.
Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
247621|NCT01226511|B1|Baseline|Duloxetine/Duloxetine|"Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.
Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
247622|NCT01226511|P2|Participant Flow|Placebo/Duloxetine|"Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.
Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
247623|NCT01226511|P1|Participant Flow|Duloxetine/Duloxetine|"Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.
Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
247624|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247625|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247626|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247627|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247628|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247629|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247630|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247631|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247632|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247633|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247634|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247635|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
247636|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
247637|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
247638|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
247639|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
247640|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
247641|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
247642|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
247643|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
247644|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
247645|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
247646|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
247647|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
247648|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
247649|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
247650|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
247651|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
247652|NCT01226511|E6|Reported Event|Placebo-Taper|AEs during the taper period for participants who were dispensed placebo prior to entering the taper phase. Participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
247653|NCT01226511|E5|Reported Event|Duloxetine-Taper|AEs during the taper period for participants who were dispensed duloxetine prior to entering the taper phase. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period.
247654|NCT01226511|E4|Reported Event|Placebo/Duloxetine-Extension Treatment|AEs during the extension treatment period for participants who received placebo capsules orally, QD during the acute treatment period (10 weeks) and flexible doses of duloxetine 30 to 120 mg orally, QD during the extension treatment period (up to 18 weeks).
247655|NCT01226511|E3|Reported Event|Duloxetine/Duloxetine-Extension Treatment|AEs during the extension treatment period for participants who received flexible doses of duloxetine 30 to 120 mg orally, QD during both the acute and extension treatment periods (up to 28 weeks).
247656|NCT01226511|E2|Reported Event|Placebo|AEs during the acute treatment period for participants who received placebo capsules orally, QD for 10 weeks.
247657|NCT01226511|E1|Reported Event|Duloxetine|Adverse events (AEs) during the acute treatment period for participants who received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks.
247658|NCT01226459|B3|Baseline|Total|Total of all reporting groups
297710|NCT00140244|E1|Reported Event|r-MetHuLeptin|
247659|NCT01226459|B2|Baseline|Minoxidil Foam|"5% Minoxidil Topical Foam
5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247660|NCT01226459|B1|Baseline|Vehicle Foam|"Vehicle Topical Foam
Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247661|NCT01226459|P2|Participant Flow|Minoxidil Foam|"5% Minoxidil Topical Foam
5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247662|NCT01226459|P1|Participant Flow|Vehicle Foam|"Vehicle Topical Foam
Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247663|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam
5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247664|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam
Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247665|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam
5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247666|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam
Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247667|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam
5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247668|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam
Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247669|NCT01226459|E2|Reported Event|Minoxidil Foam|"5% Minoxidil Topical Foam
5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247670|NCT01226459|E1|Reported Event|Vehicle Foam|"Vehicle Topical Foam
Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
247671|NCT01226420|B1|Baseline|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
247672|NCT01226420|P1|Participant Flow|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
247673|NCT01226420|O1|Outcome|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
247674|NCT01226420|O1|Outcome|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
247675|NCT01226420|E1|Reported Event|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
247676|NCT01226121|B4|Baseline|Total|Total of all reporting groups
247677|NCT01226121|B3|Baseline|Day 4 Manipulation|Finger manipulation four days following collagenase injection
247678|NCT01226121|B2|Baseline|Day 2 Manipulation|Finger manipulation two days following collagenase injection
247679|NCT01226121|B1|Baseline|Day 1 Manipulation|Finger manipulation one day following collagenase injection
247680|NCT01226121|P3|Participant Flow|Day 4 Manipulation|Finger manipulation four days following collagenase injection
247681|NCT01226121|P2|Participant Flow|Day 2 Manipulation|Finger manipulation two days following collagenase injection
247682|NCT01226121|P1|Participant Flow|Day 1 Manipulation|Finger manipulation one day following collagenase injection
247683|NCT01226121|O3|Outcome|Day 4 Manipulation|Finger manipulation four days following collagenase injection
247684|NCT01226121|O2|Outcome|Day 2 Manipulation|Finger manipulation two days following collagenase injection
247685|NCT01226121|O1|Outcome|Day 1 Manipulation|Finger manipulation one day following collagenase injection
247686|NCT01226121|O3|Outcome|Day 4 Manipulation|Finger manipulation four days following collagenase injection
247687|NCT01226121|O2|Outcome|Day 2 Manipulation|Finger manipulation two days following collagenase injection
247688|NCT01226121|O1|Outcome|Day 1 Manipulation|Finger manipulation one day following collagenase injection
247689|NCT01226121|E3|Reported Event|Day 4 Manipulation|Finger manipulation four days following collagenase injection
247690|NCT01226121|E2|Reported Event|Day 2 Manipulation|Finger manipulation two days following collagenase injection
247691|NCT01226121|E1|Reported Event|Day 1 Manipulation|Finger manipulation one day following collagenase injection
247692|NCT01226095|B1|Baseline|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247693|NCT01226095|P1|Participant Flow|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247694|NCT01226095|O1|Outcome|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247695|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247696|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
247697|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
247698|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247699|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
247700|NCT01226095|O1|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247701|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247702|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
247703|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
247704|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247705|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
247706|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247707|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
247708|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
247709|NCT01226095|O3|Outcome|Brufen Retard (All Visits)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information throughout this post-marketing observational study.
247710|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247711|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
247712|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247713|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
247714|NCT01226095|E1|Reported Event|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
247715|NCT01226043|B3|Baseline|Total|Total of all reporting groups
247716|NCT01226043|B2|Baseline|Crossover Phase: Vial & Syringe / Pen|Patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2 for the 4-week crossover phase.
247717|NCT01226043|B1|Baseline|Crossover Phase: Pen / Vial & Syringe|Patients randomized to the sequence: Lantus SoloSTAR pen in Period 1 and Lantus vial and syringe in Period 2 for the 4-week crossover phase.
247718|NCT01226043|P4|Participant Flow|Vial and Syringe|Re-randomization phase and the observational phase: patients randomized to Lantus Vial and Syringe.
247719|NCT01226043|P3|Participant Flow|SoloSTAR® Pen|Re-randomization phase and the observational phase: patients randomized to Lantus SoloSTAR® pen.
247720|NCT01226043|P2|Participant Flow|Vial &Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2.
247721|NCT01226043|P1|Participant Flow|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Lantus SoloSTAR® pen in Period 1 and Lantus vial and syringe in Period 2.
247722|NCT01226043|O6|Outcome|Observational Phase: Vial and Syringe|Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
247723|NCT01226043|O5|Outcome|Observational Phase: SoloSTAR® Pen|Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)
247724|NCT01226043|O4|Outcome|Re-randomization Phase: Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
247725|NCT01226043|O3|Outcome|Re-randomization Phase: SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
247726|NCT01226043|O2|Outcome|Crossover Phase: Vial and Syringe|Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
247727|NCT01226043|O1|Outcome|Crossover Phase: SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
247728|NCT01226043|O2|Outcome|Vial and Syringe|Patients using Vial and Syringe during the observational phase.
247729|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using SoloSTAR® pen during the observational phase.
247731|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using SoloSTAR® pen during the re-randomization phase.
247732|NCT01226043|O4|Outcome|Vial and Syringe (Period 1)|Patients using Vial and Syringe during period 1 of the crossover phase.
247733|NCT01226043|O3|Outcome|SoloSTAR® Pen (Period 2)|Patients using SoloSTAR® pen during period 2 of the crossover phase.
247734|NCT01226043|O2|Outcome|Vial and Syringe (Period 2)|Patients using Vial and Syringe during period 2 of the crossover phase.
247735|NCT01226043|O1|Outcome|SoloSTAR® Pen (Period 1)|Patients using SoloSTAR® pen during period 1 of the crossover phase.
247736|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
247737|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
247738|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
247739|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
247740|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
247741|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
247742|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
247743|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
247744|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
247745|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
247746|NCT01226043|O2|Outcome|Vial and Syringe|Vial and Syringe used during the crossover phase either at period 1 or at period 2
247747|NCT01226043|O1|Outcome|SoloSTAR® Pen|SoloSTAR® Pen used during the crossover phase either at period 1 or at period 2
247748|NCT01226043|O2|Outcome|Vial and Syringe|Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
247749|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
247750|NCT01226043|O2|Outcome|Vial and Syringe|Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
247751|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
247752|NCT01226043|E6|Reported Event|Observational Phase: Vial and Syringe|Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
247753|NCT01226043|E5|Reported Event|Observational Phase: SoloSTAR® Pen|Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)
247754|NCT01226043|E4|Reported Event|Re-randomization Phase: Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
247755|NCT01226043|E3|Reported Event|Re-randomization Phase: SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
247756|NCT01226043|E2|Reported Event|Crossover Phase: Vial and Syringe|Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
247757|NCT01226043|E1|Reported Event|Crossover Phase: SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
247758|NCT01225991|B1|Baseline|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
247759|NCT01225991|P1|Participant Flow|Milnacipran, Active Drug, Open-label|"All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day, or to their maximum tolerated dose in the course of the first week. The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
Milnacipran: All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day"
247760|NCT01225991|O1|Outcome|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
247761|NCT01225991|E1|Reported Event|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
247762|NCT01225952|B4|Baseline|Total|Total of all reporting groups
247763|NCT01225952|B3|Baseline|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247764|NCT01225952|B2|Baseline|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247765|NCT01225952|B1|Baseline|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247766|NCT01225952|P3|Participant Flow|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247767|NCT01225952|P2|Participant Flow|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247768|NCT01225952|P1|Participant Flow|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247769|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247770|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247771|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247772|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247773|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247774|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247775|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247776|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247777|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247778|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247779|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247780|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247781|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247782|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247783|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247784|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247785|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247786|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247787|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247788|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247789|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247790|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247791|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247792|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247793|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247794|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247795|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247796|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247797|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247798|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247799|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247800|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247801|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247802|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247803|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247804|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247805|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247806|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247807|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247808|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247809|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247810|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247811|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247812|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247813|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247814|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247815|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247816|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247817|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247818|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247819|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247820|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247821|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247822|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247823|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247824|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247825|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247826|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247827|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247828|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247829|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247830|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247831|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247832|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247833|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247834|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247835|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247836|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247837|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247838|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247839|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247840|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247841|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247842|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247843|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247844|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247845|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247846|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247847|NCT01225952|E3|Reported Event|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
247848|NCT01225952|E2|Reported Event|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
247849|NCT01225952|E1|Reported Event|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
247850|NCT01225926|B3|Baseline|Total|Total of all reporting groups
247851|NCT01225926|B2|Baseline|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
247852|NCT01225926|B1|Baseline|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
247853|NCT01225926|P2|Participant Flow|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
247854|NCT01225926|P1|Participant Flow|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
247855|NCT01225926|O2|Outcome|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
247856|NCT01225926|O1|Outcome|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
247857|NCT01225926|E2|Reported Event|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
247858|NCT01225926|E1|Reported Event|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
247859|NCT01225835|B3|Baseline|Total|Total of all reporting groups
247860|NCT01225835|B2|Baseline|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247861|NCT01225835|B1|Baseline|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247862|NCT01225835|P2|Participant Flow|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247863|NCT01225835|P1|Participant Flow|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247864|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247865|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247866|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247867|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247868|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247869|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247921|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
247922|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247870|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247871|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247872|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247873|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247874|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247875|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247876|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247877|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247878|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247879|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247880|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247881|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247882|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247883|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247884|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247885|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247886|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247887|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247923|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247924|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247888|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247889|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247890|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247891|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247892|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247893|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247894|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247895|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247896|NCT01225835|O1|Outcome|All Participants|The analysis of whether progesterone level is a predictor for ongoing pregnancy used all participants.
247897|NCT01225835|O6|Outcome|Follitrophin Alpha: Stratum Age >=39 Yrs|The subset of participants in the follitrophin alpha treatment arm who were >= 39 years old.
247898|NCT01225835|O5|Outcome|Follitrophin Alpha: Stratum Age <39 Yrs|The subset of participants in the follitrophin alpha treatment arm who were < 39 years old.
247899|NCT01225835|O4|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247900|NCT01225835|O3|Outcome|Menotrophin: Stratum Age >=39 Yrs|The subset of participants in the menotrophin treatment arm who were >= 39 years old.
247901|NCT01225835|O2|Outcome|Menotrophin: Stratum Age <39 Yrs|The subset of participants in the menotrophin treatment arm who were < 39 years old.
247902|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247903|NCT01225835|E2|Reported Event|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247904|NCT01225835|E1|Reported Event|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
247905|NCT01225822|B6|Baseline|Total|Total of all reporting groups
247906|NCT01225822|B5|Baseline|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
247907|NCT01225822|B4|Baseline|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247908|NCT01225822|B3|Baseline|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247909|NCT01225822|B2|Baseline|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247910|NCT01225822|B1|Baseline|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247911|NCT01225822|P5|Participant Flow|Enoxaparin 40 mg qd|Enoxaparin 40 qd (once daily) subcutaneous injection
247912|NCT01225822|P4|Participant Flow|BIBR 1048 300 mg qd|Dabigatran 300 mg qd(once daily) oral
247913|NCT01225822|P3|Participant Flow|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid(twice daily) oral
247914|NCT01225822|P2|Participant Flow|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid(twice daily) oral
247915|NCT01225822|P1|Participant Flow|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid(twice daily) oral
247916|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
247917|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247918|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247919|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247920|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247926|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
247927|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247928|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247929|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247930|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247931|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
247932|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247933|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247934|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247935|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247936|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
247937|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247938|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247939|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247940|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247941|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
247942|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247943|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247944|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247945|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247946|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40mg qd (once daily) subcutaneous injection
247947|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247948|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247949|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247950|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247951|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mgqd (once daily) subcutaneous injection
247952|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247953|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247954|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247955|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247956|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
247957|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247958|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247959|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247960|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247961|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
247962|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247963|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247964|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247965|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247966|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
247967|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247968|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247969|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247970|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247971|NCT01225822|E5|Reported Event|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
247972|NCT01225822|E4|Reported Event|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
247973|NCT01225822|E3|Reported Event|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
247974|NCT01225822|E2|Reported Event|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
247975|NCT01225822|E1|Reported Event|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
247976|NCT01225731|B6|Baseline|Total|Total of all reporting groups
247977|NCT01225731|B5|Baseline|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
247978|NCT01225731|B4|Baseline|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
247979|NCT01225731|B3|Baseline|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
247980|NCT01225731|B2|Baseline|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
247981|NCT01225731|B1|Baseline|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
247982|NCT01225731|P13|Participant Flow|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
247983|NCT01225731|P12|Participant Flow|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
247984|NCT01225731|P11|Participant Flow|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
247985|NCT01225731|P10|Participant Flow|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
247986|NCT01225731|P9|Participant Flow|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
247987|NCT01225731|P8|Participant Flow|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
247988|NCT01225731|P7|Participant Flow|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
247989|NCT01225731|P6|Participant Flow|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
247990|NCT01225731|P5|Participant Flow|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
247991|NCT01225731|P4|Participant Flow|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
247992|NCT01225731|P3|Participant Flow|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
247993|NCT01225731|P2|Participant Flow|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
247994|NCT01225731|P1|Participant Flow|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
247995|NCT01225731|O9|Outcome|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
247996|NCT01225731|O8|Outcome|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
247997|NCT01225731|O7|Outcome|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
247998|NCT01225731|O6|Outcome|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
247999|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248000|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248001|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248002|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248003|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248004|NCT01225731|O13|Outcome|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
248005|NCT01225731|O12|Outcome|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
248006|NCT01225731|O11|Outcome|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
248007|NCT01225731|O10|Outcome|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
248008|NCT01225731|O9|Outcome|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
248009|NCT01225731|O8|Outcome|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
248010|NCT01225731|O7|Outcome|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
248011|NCT01225731|O6|Outcome|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
248012|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248013|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248014|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248015|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248016|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248017|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248018|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248019|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248020|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248021|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248022|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248023|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248024|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248025|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248026|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248027|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248028|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248029|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248030|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248031|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248032|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248033|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248034|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248035|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248036|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248037|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248038|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248039|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248097|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
248040|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248041|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248042|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248043|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248044|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248045|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248046|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248047|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248048|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248049|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248050|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248051|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248052|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248053|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248054|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248055|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248056|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248057|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248058|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248059|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248060|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248061|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248062|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248063|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248064|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248065|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248066|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248067|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248068|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248069|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248070|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248071|NCT01225731|E14|Reported Event|Placebo Follow-up|Participants who received placebo in Part 1 and did not receive additional therapy.
248072|NCT01225731|E13|Reported Event|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
248073|NCT01225731|E12|Reported Event|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
248074|NCT01225731|E11|Reported Event|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
248075|NCT01225731|E10|Reported Event|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
248076|NCT01225731|E9|Reported Event|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
248077|NCT01225731|E8|Reported Event|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
248078|NCT01225731|E7|Reported Event|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
248079|NCT01225731|E6|Reported Event|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
248080|NCT01225731|E5|Reported Event|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
248081|NCT01225731|E4|Reported Event|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
248082|NCT01225731|E3|Reported Event|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
248083|NCT01225731|E2|Reported Event|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
248084|NCT01225731|E1|Reported Event|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
248085|NCT01225562|B4|Baseline|Total|Total of all reporting groups
248086|NCT01225562|B3|Baseline|Placebo|Matching placebo
248087|NCT01225562|B2|Baseline|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
248088|NCT01225562|B1|Baseline|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
248089|NCT01225562|P3|Participant Flow|Placebo|Matching placebo
248090|NCT01225562|P2|Participant Flow|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
248091|NCT01225562|P1|Participant Flow|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
248092|NCT01225562|O3|Outcome|Placebo|Matching placebo
248093|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
248094|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
248095|NCT01225562|O3|Outcome|Placebo|Matching placebo
248096|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
248099|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
248100|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
248101|NCT01225562|O3|Outcome|Placebo|Matching placebo
248102|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
248103|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
248104|NCT01225562|E3|Reported Event|Ticagrelor 90mg bd|
248105|NCT01225562|E2|Reported Event|Ticagrelor 60mg bd|
248106|NCT01225562|E1|Reported Event|Placebo|
248107|NCT01225549|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study
248108|NCT01225549|P10|Participant Flow|PCBA|Placebo followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg
248109|NCT01225549|P9|Participant Flow|PCAB|Placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg followed by AZD5423 300 µg od
248110|NCT01225549|P8|Participant Flow|PBAC|Placebo followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid
248111|NCT01225549|P7|Participant Flow|CBPA|Budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo followed by AZD5423 75 µg
248112|NCT01225549|P6|Participant Flow|CBAP|Budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by placebo
248113|NCT01225549|P5|Participant Flow|CAPB|Budesonide 200 µg bid followed by AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od
248114|NCT01225549|P4|Participant Flow|BPCA|AZD5423 300 µg od followed by placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg
248115|NCT01225549|P3|Participant Flow|BACP|AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid followed by placebo
248116|NCT01225549|P2|Participant Flow|APBC|AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od followed by budesonide 200 µg bid
248117|NCT01225549|P1|Participant Flow|ACBP|AZD5423 75 µg followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo
248118|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
248119|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
248120|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248121|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248122|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
248123|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
248124|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248125|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248126|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
248127|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
248128|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248129|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248130|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
248131|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
248132|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248133|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248134|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
248135|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
248136|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248137|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248138|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
248139|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
248140|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248141|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248142|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
248143|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
248144|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248145|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248146|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
248147|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
248148|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248149|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248150|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
248151|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
248152|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248153|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248154|NCT01225549|E4|Reported Event|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
248155|NCT01225549|E3|Reported Event|Arm 3 - 2x200ug Budesonide|2x200ug budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
248156|NCT01225549|E2|Reported Event|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248157|NCT01225549|E1|Reported Event|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
248158|NCT01225354|B1|Baseline|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
248159|NCT01225354|P1|Participant Flow|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
248160|NCT01225354|O1|Outcome|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
248161|NCT01225354|O1|Outcome|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
248162|NCT01225354|E1|Reported Event|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
248163|NCT01225289|B3|Baseline|Total|Total of all reporting groups
248164|NCT01225289|B2|Baseline|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
248165|NCT01225289|B1|Baseline|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
248166|NCT01225289|P2|Participant Flow|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
248167|NCT01225289|P1|Participant Flow|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
248168|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
248169|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
248170|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
248171|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
248172|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
248173|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
248174|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
248175|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
248176|NCT01225289|E2|Reported Event|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
248177|NCT01225289|E1|Reported Event|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
248178|NCT01225263|B3|Baseline|Total|Total of all reporting groups
248179|NCT01225263|B2|Baseline|Placebo|Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months
248180|NCT01225263|B1|Baseline|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
248181|NCT01225263|P2|Participant Flow|"Placebo Sugar Pill"|Participants in this arm took placebo pills, which looked like the Simvastatin and Vitamin D. Two placebo pills were taken twice daily for 6 months.
248182|NCT01225263|P1|Participant Flow|Simvastatin and Vitamin D|Participants in this arm took Simvastatin 20 mg twice daily for 6 months plus Vitamin D3 1000 IU twice daily for 6 months.
248183|NCT01225263|O2|Outcome|Placebo|Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months
248184|NCT01225263|O1|Outcome|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
248185|NCT01225263|O2|Outcome|Placebo|Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
248186|NCT01225263|O1|Outcome|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
248187|NCT01225263|E2|Reported Event|Placebo|Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
248188|NCT01225263|E1|Reported Event|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
248189|NCT01225211|B11|Baseline|Total|Total of all reporting groups
248360|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months"
248190|NCT01225211|B10|Baseline|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
248191|NCT01225211|B9|Baseline|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
248192|NCT01225211|B8|Baseline|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248193|NCT01225211|B7|Baseline|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248194|NCT01225211|B6|Baseline|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248195|NCT01225211|B5|Baseline|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248196|NCT01225211|B4|Baseline|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
248197|NCT01225211|B3|Baseline|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
248198|NCT01225211|B2|Baseline|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
248199|NCT01225211|B1|Baseline|Cohort 1: Placebo|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
248200|NCT01225211|P10|Participant Flow|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
248201|NCT01225211|P9|Participant Flow|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
248202|NCT01225211|P8|Participant Flow|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248203|NCT01225211|P7|Participant Flow|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248204|NCT01225211|P6|Participant Flow|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248205|NCT01225211|P5|Participant Flow|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248206|NCT01225211|P4|Participant Flow|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
248207|NCT01225211|P3|Participant Flow|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
248208|NCT01225211|P2|Participant Flow|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).
248209|NCT01225211|P1|Participant Flow|Cohort 1: Placebo|Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).
248210|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
248211|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
248212|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
248213|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
248214|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
248573|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
248215|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
248216|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
248217|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248218|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248219|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248220|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248221|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248222|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
248223|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
248224|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
248225|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248226|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)|Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248227|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248228|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248229|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248230|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
248231|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248232|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)|Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248233|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248234|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248235|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248236|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
248237|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248238|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248239|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248240|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
297711|NCT00140413|B4|Baseline|Total|Total of all reporting groups
248241|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248242|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
248243|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248244|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248245|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248246|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248247|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248248|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
248249|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
248250|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
248251|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
248252|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
248253|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
248254|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
248255|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
248256|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
248257|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
248258|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd (HE) – Period 1|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
248259|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd (HO) – Period 1|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
248260|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
248261|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
248262|NCT01225211|O2|Outcome|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
248263|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
248264|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
248265|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
248266|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
248267|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248268|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248269|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248270|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248271|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248574|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
248272|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
248273|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
248274|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
248275|NCT01225211|O2|Outcome|Cohort 4: Active Study Drug|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
248276|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
248277|NCT01225211|O10|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248278|NCT01225211|O9|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248279|NCT01225211|O8|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248280|NCT01225211|O7|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248281|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
248282|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
248283|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
248284|NCT01225211|O3|Outcome|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
248285|NCT01225211|O2|Outcome|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
248286|NCT01225211|O1|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
248287|NCT01225211|O5|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
248288|NCT01225211|O4|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
248289|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
248290|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
248291|NCT01225211|O1|Outcome|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
248292|NCT01225211|E17|Reported Event|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
248293|NCT01225211|E16|Reported Event|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
248294|NCT01225211|E15|Reported Event|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
248295|NCT01225211|E14|Reported Event|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248296|NCT01225211|E13|Reported Event|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248297|NCT01225211|E12|Reported Event|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248298|NCT01225211|E11|Reported Event|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
248299|NCT01225211|E10|Reported Event|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
248300|NCT01225211|E9|Reported Event|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
248301|NCT01225211|E8|Reported Event|Cohort 2: LUM 600 mg qd – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
248302|NCT01225211|E7|Reported Event|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
248303|NCT01225211|E6|Reported Event|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
248304|NCT01225211|E5|Reported Event|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
248305|NCT01225211|E4|Reported Event|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
248306|NCT01225211|E3|Reported Event|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
248307|NCT01225211|E2|Reported Event|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
248308|NCT01225211|E1|Reported Event|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
248309|NCT01225159|B3|Baseline|Total|Total of all reporting groups
248310|NCT01225159|B2|Baseline|Conventional Glycaemic Control (Control)|Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
248311|NCT01225159|B1|Baseline|Tight Glycaemic Control (TGC)|TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.
248312|NCT01225159|P2|Participant Flow|Conventional Glycaemic Control (Control)|"Allocated to control group (n = 100)
• Received allocated intervention (n = 100)"
248313|NCT01225159|P1|Participant Flow|Tight Glycaemic Control (TGC)|"Allocated to intensive group (n = 100)
Received allocated intervention (n = 99)
Did not receive allocated intervention: change operation (n = 1)"
248314|NCT01225159|O2|Outcome|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)
• Received allocated intervention (n = 100)"
248315|NCT01225159|O1|Outcome|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)
Received allocated intervention (n = 99)
Did not receive allocated intervention: change operation (n = 1)"
248316|NCT01225159|O2|Outcome|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)
• Received allocated intervention (n = 100)"
248317|NCT01225159|O1|Outcome|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)
Received allocated intervention (n = 99)
Did not receive allocated intervention: change operation (n = 1)"
248318|NCT01225159|E2|Reported Event|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)
• Received allocated intervention (n = 100)"
248319|NCT01225159|E1|Reported Event|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)
Received allocated intervention (n = 99)
Did not receive allocated intervention: change operation (n = 1)"
248320|NCT01225146|B3|Baseline|Total|Total of all reporting groups
248321|NCT01225146|B2|Baseline|Cohort 2|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248322|NCT01225146|B1|Baseline|Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248323|NCT01225146|P2|Participant Flow|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248324|NCT01225146|P1|Participant Flow|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248325|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248326|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248327|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248328|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248424|NCT01224639|B2|Baseline|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248329|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248330|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248331|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248332|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248333|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
248334|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria."
248335|NCT01225146|O2|Outcome|Treatment Naive (Cohort 2)|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248336|NCT01225146|O1|Outcome|Treatment Experienced (Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248337|NCT01225146|E2|Reported Event|Cohort 2|"Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248338|NCT01225146|E1|Reported Event|Cohort 1|"Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution."
248339|NCT01225068|B3|Baseline|Total|Total of all reporting groups
248340|NCT01225068|B2|Baseline|Placebo|Placebo treatment group
248341|NCT01225068|B1|Baseline|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
248342|NCT01225068|P2|Participant Flow|Placebo|Placebo treatment group
248343|NCT01225068|P1|Participant Flow|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
248344|NCT01225068|O2|Outcome|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
248345|NCT01225068|O1|Outcome|Placebo|Placebo arm
248346|NCT01225068|E2|Reported Event|Placebo|Placebo treatment group
248347|NCT01225068|E1|Reported Event|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
248348|NCT01225055|B4|Baseline|Total|Total of all reporting groups
248349|NCT01225055|B3|Baseline|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months"
248350|NCT01225055|B2|Baseline|Vibration|"Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months"
248351|NCT01225055|B1|Baseline|Teriparatide|"Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months"
248352|NCT01225055|P3|Participant Flow|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months"
248353|NCT01225055|P2|Participant Flow|Vibration|"Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months"
248354|NCT01225055|P1|Participant Flow|Teriparatide|"Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months"
248355|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months"
248356|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months"
248357|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months"
248358|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months"
248359|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months"
298124|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
248361|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months"
248362|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months"
248363|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months"
248364|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months"
248365|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months"
248366|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months"
248367|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months"
248368|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months"
248369|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months"
248370|NCT01225055|O3|Outcome|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months"
248371|NCT01225055|O2|Outcome|Vibration|"Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months"
248372|NCT01225055|O1|Outcome|Teriparatide|"Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months"
248373|NCT01225055|E3|Reported Event|Teriparatide and Vibration|"Teriparatide with vibration applied in conjuction
Teriparatide: 20 ug daily over 12 months
vibration: 10 min/day for 12 months"
248374|NCT01225055|E2|Reported Event|Vibration|"Vibration alone with placebo-teriparatide
vibration: 10 min/day for 12 months"
248375|NCT01225055|E1|Reported Event|Teriparatide|"Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months"
248376|NCT01225029|B3|Baseline|Total|Total of all reporting groups
248377|NCT01225029|B2|Baseline|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
248378|NCT01225029|B1|Baseline|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
248379|NCT01225029|P2|Participant Flow|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
248380|NCT01225029|P1|Participant Flow|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
248381|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
248382|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
248383|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
248384|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
248385|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
248386|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
248387|NCT01225029|E2|Reported Event|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
248388|NCT01225029|E1|Reported Event|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
248389|NCT01224821|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248390|NCT01224821|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248575|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
248576|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
248391|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248392|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248393|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248394|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248395|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248396|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248397|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248425|NCT01224639|B1|Baseline|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248426|NCT01224639|P8|Participant Flow|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248398|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248399|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248400|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248401|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248402|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248403|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248404|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248427|NCT01224639|P7|Participant Flow|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248428|NCT01224639|P6|Participant Flow|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248405|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248406|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248407|NCT01224821|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
248408|NCT01224782|B1|Baseline|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
248409|NCT01224782|P1|Participant Flow|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
248410|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
248411|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
248412|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
248413|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
248414|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
248415|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
248416|NCT01224782|E1|Reported Event|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
248417|NCT01224639|B9|Baseline|Total|Total of all reporting groups
248418|NCT01224639|B8|Baseline|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248419|NCT01224639|B7|Baseline|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248420|NCT01224639|B6|Baseline|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248421|NCT01224639|B5|Baseline|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248422|NCT01224639|B4|Baseline|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248423|NCT01224639|B3|Baseline|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248429|NCT01224639|P5|Participant Flow|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248430|NCT01224639|P4|Participant Flow|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248431|NCT01224639|P3|Participant Flow|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248432|NCT01224639|P2|Participant Flow|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248433|NCT01224639|P1|Participant Flow|Low Dose Subcutaneous: TDV|TDV 0.5 milliliter (mL), injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) (previously DENVax) comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 plaque forming units (PFU), TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248434|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248435|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248436|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248437|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248438|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248439|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248440|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248441|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248442|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248443|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248444|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248445|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248446|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248447|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248448|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248449|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248450|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248451|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248452|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248565|NCT01224236|O1|Outcome|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
248566|NCT01224236|E2|Reported Event|Control|multivitamin solution without iron
248453|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248454|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248455|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248456|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248457|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248458|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248459|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248460|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248461|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248462|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248463|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248464|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248465|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248466|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248467|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248468|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248469|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248470|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248471|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248472|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248473|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248474|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248475|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248476|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248567|NCT01224236|E1|Reported Event|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
248568|NCT01224171|B3|Baseline|Total|Total of all reporting groups
248736|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
248477|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248478|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248479|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248480|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248481|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248482|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248483|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248484|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248485|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248486|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248487|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248488|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248489|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248490|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248491|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248492|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248493|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248494|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248495|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248496|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248497|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248498|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248499|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248500|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248569|NCT01224171|B2|Baseline|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
248570|NCT01224171|B1|Baseline|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
248737|NCT01222520|O2|Outcome|Telmisartan|
248501|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248502|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248503|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248504|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248505|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248506|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248507|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248508|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248509|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248510|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248511|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248512|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248513|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248514|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248515|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248516|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248517|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248518|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248519|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248520|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248521|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248522|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248523|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248524|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248571|NCT01224171|P2|Participant Flow|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
248572|NCT01224171|P1|Participant Flow|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
248525|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248526|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248527|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248528|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248529|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248530|NCT01224639|E8|Reported Event|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248531|NCT01224639|E7|Reported Event|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248532|NCT01224639|E6|Reported Event|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248533|NCT01224639|E5|Reported Event|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
248534|NCT01224639|E4|Reported Event|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
248535|NCT01224639|E3|Reported Event|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248536|NCT01224639|E2|Reported Event|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
248537|NCT01224639|E1|Reported Event|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
248538|NCT01224626|B1|Baseline|Linezolid|Participants who have been treated with Zyvox (linezolid).
248539|NCT01224626|P1|Participant Flow|Linezolid|Participants who have been treated with Zyvox (linezolid).
248540|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
248541|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
248542|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
248543|NCT01224626|E1|Reported Event|Linezolid|Participants who have been treated with Zyvox (linezolid).
248544|NCT01224444|B1|Baseline|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
248545|NCT01224444|P1|Participant Flow|All Adenomatous Polyps|Standard polypectomy snare of adenomatous polyps (included serrated adenomas) from ≥5mm to ≤20mm.
248546|NCT01224444|O1|Outcome|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≥5mm and ≤20mm.
248547|NCT01224444|E1|Reported Event|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
248548|NCT01224431|B3|Baseline|Total|Total of all reporting groups
248549|NCT01224431|B2|Baseline|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
248550|NCT01224431|B1|Baseline|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
248551|NCT01224431|P2|Participant Flow|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
248552|NCT01224431|P1|Participant Flow|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
248553|NCT01224431|O2|Outcome|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
248554|NCT01224431|O1|Outcome|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
248555|NCT01224431|E2|Reported Event|Placebo Comparator: Normal Saline Via Needleless Injection|
248556|NCT01224431|E1|Reported Event|Experimental: Needleless Injection of Buffered Lidocaine|
248557|NCT01224236|B3|Baseline|Total|Total of all reporting groups
248558|NCT01224236|B2|Baseline|Control|multivitamin solution without iron
248559|NCT01224236|B1|Baseline|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
248560|NCT01224236|P2|Participant Flow|Control|multivitamin solution without iron
248561|NCT01224236|P1|Participant Flow|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
248562|NCT01224236|O2|Outcome|Control|multivitamin solution without iron
248563|NCT01224236|O1|Outcome|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
248564|NCT01224236|O2|Outcome|Control|multivitamin solution without iron
248577|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
248578|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
248579|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
248580|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
248581|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
248582|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
248583|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
248584|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
248585|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
248586|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
248587|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
248588|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
248589|NCT01224171|E2|Reported Event|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
248590|NCT01224171|E1|Reported Event|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
248591|NCT01222533|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study.
248592|NCT01222533|P1|Participant Flow|Study Overall|Total number of patients randomised and treated in the study. This was a randomised 5-period crossover trial. 154 patients were randomised to one of 15 sequences and treated. The trial was blinded within the 4 Respimat treatments, but open for the HandiHaler treatment. Each of the 5 treatment regimens was taken for 4 weeks without washouts between treatment periods.
248593|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248594|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248595|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248596|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248597|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248598|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248599|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248600|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248601|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248602|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248603|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248604|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248605|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248606|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248607|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248608|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248609|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248610|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248611|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248612|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248613|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248614|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248615|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248616|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248617|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248618|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248619|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248620|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248621|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248622|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248623|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248624|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248625|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248626|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248627|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248738|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
248628|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248629|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248630|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248631|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248632|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248633|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248634|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248635|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248636|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248637|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248638|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248639|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248640|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248641|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248642|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248643|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248644|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248645|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248646|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248647|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248648|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248649|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248650|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248651|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248652|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248653|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248654|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248655|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248656|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248657|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248658|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248659|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248660|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248661|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248662|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248663|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248664|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248665|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248666|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248667|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248668|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248669|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248670|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248671|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248672|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248673|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248674|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248675|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248676|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248677|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248678|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248679|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248739|NCT01222520|O2|Outcome|Telmisartan|
248680|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248681|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248682|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248683|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248684|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248685|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248686|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248687|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248688|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248689|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248690|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248691|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248692|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248693|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248694|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248695|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248696|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248697|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248698|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248699|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248700|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248701|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248702|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248703|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248704|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248705|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248706|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248707|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248708|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248709|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248710|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248711|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248712|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248713|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248714|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248715|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248716|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248717|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248718|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248719|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248720|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248721|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248722|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248723|NCT01222533|E5|Reported Event|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
248724|NCT01222533|E4|Reported Event|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
248725|NCT01222533|E3|Reported Event|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
248726|NCT01222533|E2|Reported Event|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
248727|NCT01222533|E1|Reported Event|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
248728|NCT01222520|B3|Baseline|Total|Total of all reporting groups
248729|NCT01222520|B2|Baseline|Telmisartan|
248730|NCT01222520|B1|Baseline|Telmisartan and Amlodipine FDC|
248731|NCT01222520|P2|Participant Flow|Telmisartan|
248732|NCT01222520|P1|Participant Flow|Telmisartan and Amlodipine FDC|
248733|NCT01222520|O2|Outcome|Telmisartan|
248734|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
248735|NCT01222520|O2|Outcome|Telmisartan|
248749|NCT01222507|B1|Baseline|Brain Speed Test|60 subjects who complete 60 Second Brain Game and Brain Speed Test
248750|NCT01222507|P1|Participant Flow|Brain Speed Test (BST)|60 subjects who complete 60 Second Brain Game and Brain Speed Test
248751|NCT01222507|O1|Outcome|Brain Processing Speed|Brain Speed Test is measured through Brain Speed Test, and the results are transformed to z-scores based on normal population data.Z-score is calculated by subtracting the raw score (x) from the mean of the population (µ) which is then divided by the standard deviation of the population.
248752|NCT01222507|E1|Reported Event|Brain Speed Test|60 subjects who complete 60 Second Brain Game and Brain Speed Test
248753|NCT01222416|B3|Baseline|Total|Total of all reporting groups
248754|NCT01222416|B2|Baseline|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
248755|NCT01222416|B1|Baseline|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
248756|NCT01222416|P2|Participant Flow|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
248757|NCT01222416|P1|Participant Flow|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
248758|NCT01222416|O2|Outcome|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
248759|NCT01222416|O1|Outcome|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
248760|NCT01222416|O2|Outcome|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
248761|NCT01222416|O1|Outcome|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
248762|NCT01222416|E2|Reported Event|Fluorodeoxythymidine PET/CT (FLT-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical: [18F]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection."
248763|NCT01222416|E1|Reported Event|Fluorodeoxyglucose PET/CT (FDG-PET/CT)|"A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical Administration [18F]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection."
248764|NCT01224015|B4|Baseline|Total|Total of all reporting groups
248765|NCT01224015|B3|Baseline|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248766|NCT01224015|B2|Baseline|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248767|NCT01224015|B1|Baseline|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248768|NCT01224015|P3|Participant Flow|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248769|NCT01224015|P2|Participant Flow|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248770|NCT01224015|P1|Participant Flow|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248771|NCT01224015|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248772|NCT01224015|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248837|NCT01222286|P2|Participant Flow|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248773|NCT01224015|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248774|NCT01224015|E3|Reported Event|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248775|NCT01224015|E2|Reported Event|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248776|NCT01224015|E1|Reported Event|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
248777|NCT01223937|B3|Baseline|Total|Total of all reporting groups
248778|NCT01223937|B2|Baseline|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248779|NCT01223937|B1|Baseline|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248780|NCT01223937|P2|Participant Flow|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248781|NCT01223937|P1|Participant Flow|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248782|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248783|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248784|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248785|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248786|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248787|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248788|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248789|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248790|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248791|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248792|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248793|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248794|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248795|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248796|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248797|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248798|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248799|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248800|NCT01223937|E2|Reported Event|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248801|NCT01223937|E1|Reported Event|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
248802|NCT01223703|B3|Baseline|Total|Total of all reporting groups
248803|NCT01223703|B2|Baseline|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
248804|NCT01223703|B1|Baseline|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
248805|NCT01223703|P2|Participant Flow|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
248806|NCT01223703|P1|Participant Flow|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
248807|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
248808|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
248809|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
248810|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
248811|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
248812|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
248813|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
248814|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
248815|NCT01223703|E2|Reported Event|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
248816|NCT01223703|E1|Reported Event|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
248817|NCT01222403|B3|Baseline|Total|Total of all reporting groups
248818|NCT01222403|B2|Baseline|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248819|NCT01222403|B1|Baseline|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248820|NCT01222403|P2|Participant Flow|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248821|NCT01222403|P1|Participant Flow|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248822|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248823|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248824|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248825|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248826|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248827|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248828|NCT01222403|E2|Reported Event|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248829|NCT01222403|E1|Reported Event|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
248830|NCT01222390|B1|Baseline|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).
Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
248831|NCT01222390|P1|Participant Flow|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).
Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
248832|NCT01222390|O1|Outcome|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).
Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
248833|NCT01222390|E1|Reported Event|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).
Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
248834|NCT01222286|B3|Baseline|Total|Total of all reporting groups
248835|NCT01222286|B2|Baseline|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248836|NCT01222286|B1|Baseline|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248838|NCT01222286|P1|Participant Flow|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248839|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248840|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248841|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248842|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248843|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248844|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248845|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248846|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248847|NCT01222286|E2|Reported Event|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248848|NCT01222286|E1|Reported Event|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
248849|NCT01222234|B4|Baseline|Total|Total of all reporting groups
248850|NCT01222234|B3|Baseline|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
248851|NCT01222234|B2|Baseline|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
calcitriol: calcitriol 0.25 mcg every day"
248852|NCT01222234|B1|Baseline|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
248853|NCT01222234|P3|Participant Flow|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
248854|NCT01222234|P2|Participant Flow|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
calcitriol: calcitriol 0.25 mcg every day"
248855|NCT01222234|P1|Participant Flow|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
248856|NCT01222234|O2|Outcome|Group 3: Non-CKD Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
248857|NCT01222234|O1|Outcome|Group 1: CKD Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
248858|NCT01222234|O2|Outcome|Group 2: Calcitriol - CKD|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Calcitriol 0.25 mcg every day"
248859|NCT01222234|O1|Outcome|Group 1: Cholecalciferol - CKD|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Cholecalciferol 50,000 IU twice weekly for 8 weeks"
248860|NCT01222234|E3|Reported Event|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
248861|NCT01222234|E2|Reported Event|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
calcitriol: calcitriol 0.25 mcg every day"
248862|NCT01222234|E1|Reported Event|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
248863|NCT01223469|B3|Baseline|Total|Total of all reporting groups
248864|NCT01223469|B2|Baseline|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
248865|NCT01223469|B1|Baseline|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
248866|NCT01223469|P2|Participant Flow|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
248867|NCT01223469|P1|Participant Flow|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
248868|NCT01223469|O2|Outcome|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
248869|NCT01223469|O1|Outcome|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
248870|NCT01223469|E2|Reported Event|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
248871|NCT01223469|E1|Reported Event|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
248872|NCT01223365|B1|Baseline|Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at th3 successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
248873|NCT01223365|P1|Participant Flow|Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at the successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
298125|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
248874|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
248875|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
248876|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
248877|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
248878|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
248879|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
248880|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
248881|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
248882|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
248883|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
248884|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
248885|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
248886|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
248887|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
248888|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
248889|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
248890|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
248891|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
248892|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
248893|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
248894|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
248895|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
248896|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
248897|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
248898|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
248899|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
248900|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
248901|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
248902|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
248903|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
248904|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
248905|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
248906|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
248907|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
248908|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
248909|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
248910|NCT01223365|E3|Reported Event|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
248911|NCT01223365|E2|Reported Event|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
248912|NCT01223365|E1|Reported Event|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
248913|NCT01223352|B3|Baseline|Total|Total of all reporting groups
248914|NCT01223352|B2|Baseline|Bosentan 2 mg/kg b.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally twice daily (b.i.d.) for a planned duration of 24 weeks
248915|NCT01223352|B1|Baseline|Bosentan 2 mg/kg t.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally three times a day (t.i.d.) for a planned duration of 24 weeks
248916|NCT01223352|P2|Participant Flow|Bosentan 2 mg/kg b.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally twice daily (b.i.d.) for a planned duration of 24 weeks
248917|NCT01223352|P1|Participant Flow|Bosentan 2 mg/kg t.i.d.|2 mg/kg bosentan (dispersible tablets) was administered orally three times a day (t.i.d.) for a planned duration of 24 weeks
248918|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (ITT Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan.
248919|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (ITT Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan.
248920|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (ITT Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan.
248921|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (ITT Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan.
248922|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d.|Patients randomized to the bosentan 2 mg/kg b.i.d. group
248923|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d.|Patients randomized to the bosentan 2 mg/kg t.i.d. group
248924|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d|Patients randomized to the bosentan 2 mg/kg b.i.d. group.
248925|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d.|Patients randomized to the bosentan 2 mg/kg t.i.d. group.
248926|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
248927|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
248928|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
248929|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
248930|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
248931|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
248932|NCT01223352|O2|Outcome|Bosentan 2 mg/kg b.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg b.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
248933|NCT01223352|O1|Outcome|Bosentan 2 mg/kg t.i.d. (PK Set)|Patients randomized to the bosentan 2 mg/kg t.i.d. group who received at least one oral dose of bosentan and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.
248934|NCT01223352|E2|Reported Event|Bosentan 2 mg/kg b.i.d|Patients received 2 mg/kg of bosentan twice daily (morning and evening) for at least 6 weeks and up to 26.4 weeks
248935|NCT01223352|E1|Reported Event|Bosentan 2 mg/kg t.i.d|Patients received 2 mg/kg of bosentan 3 times a day (morning, afternoon, evening) for at least 0.4 week and up to 28.7 weeks
248936|NCT01223196|B3|Baseline|Total|Total of all reporting groups
248937|NCT01223196|B2|Baseline|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
248938|NCT01223196|B1|Baseline|Placebo|One arm of the study subjects will be treated with Placebo only.
248939|NCT01223196|P2|Participant Flow|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
248940|NCT01223196|P1|Participant Flow|Placebo|One arm of the study subjects will be treated with Placebo only, once a day.
248941|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
248942|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only, once a day.
248943|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
248944|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only.
248945|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
248946|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only.
248947|NCT01223196|E2|Reported Event|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
248948|NCT01223196|E1|Reported Event|Placebo|One arm of the study subjects will be treated with Placebo only.
248949|NCT01223027|B3|Baseline|Total|Total of all reporting groups
248950|NCT01223027|B2|Baseline|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
248951|NCT01223027|B1|Baseline|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
248952|NCT01223027|P2|Participant Flow|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
248953|NCT01223027|P1|Participant Flow|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
248954|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
248955|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
248956|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
250330|NCT01218100|E3|Reported Event|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
248957|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
248958|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
248959|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
248960|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
248961|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
248962|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
248963|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
248964|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
248965|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
248966|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
248967|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
248968|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
248969|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
248970|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
248971|NCT01223027|E2|Reported Event|Sorafenib|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
248972|NCT01223027|E1|Reported Event|Dovitinib|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
248973|NCT01223001|B3|Baseline|Total|Total of all reporting groups
248974|NCT01223001|B2|Baseline|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
248975|NCT01223001|B1|Baseline|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
248976|NCT01223001|P2|Participant Flow|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
248977|NCT01223001|P1|Participant Flow|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
248978|NCT01223001|O2|Outcome|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
248979|NCT01223001|O1|Outcome|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
248980|NCT01223001|E2|Reported Event|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
248981|NCT01223001|E1|Reported Event|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
248982|NCT01222884|B3|Baseline|Total|Total of all reporting groups
248983|NCT01222884|B2|Baseline|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
248984|NCT01222884|B1|Baseline|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
248985|NCT01222884|P2|Participant Flow|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
248986|NCT01222884|P1|Participant Flow|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
248987|NCT01222884|O2|Outcome|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
248988|NCT01222884|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
248989|NCT01222884|O2|Outcome|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
248990|NCT01222884|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
248991|NCT01222884|E2|Reported Event|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
248992|NCT01222884|E1|Reported Event|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
248993|NCT01222832|B3|Baseline|Total|Total of all reporting groups
248994|NCT01222832|B2|Baseline|Saline|Nasopore sponge soaked in saline
248995|NCT01222832|B1|Baseline|Bacitracin|"Nasopore sponge soaked in Bacitracin
Bacitracin: Bacitracin soaked sponge"
248996|NCT01222832|P2|Participant Flow|Saline|Saline soaked sponge and oral antibiotics
248997|NCT01222832|P1|Participant Flow|Bacitracin|"Nasopore sponge soaked in Bacitracin
Bacitracin: Bacitracin soaked sponge"
248998|NCT01222832|O2|Outcome|Saline|Saline soaked sponge and oral antibiotics
248999|NCT01222832|O1|Outcome|Bacitracin|Bacitracin soaked sponge
249000|NCT01222832|E2|Reported Event|Saline|Saline soaked sponge and oral antibiotics
249001|NCT01222832|E1|Reported Event|Bacitracin|Bacitracin soaked sponge
249002|NCT01222715|B3|Baseline|Total|Total of all reporting groups
249003|NCT01222715|B2|Baseline|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
249004|NCT01222715|B1|Baseline|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
249005|NCT01222715|P2|Participant Flow|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
249006|NCT01222715|P1|Participant Flow|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
249007|NCT01222715|O2|Outcome|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
249008|NCT01222715|O1|Outcome|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
249009|NCT01222715|O2|Outcome|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
249010|NCT01222715|O1|Outcome|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
249011|NCT01222715|O2|Outcome|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
249012|NCT01222715|O1|Outcome|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
249013|NCT01222715|E2|Reported Event|Regimen B|Vinorelbine/cyclophosphamide (VC) + temsirolimus
249014|NCT01222715|E1|Reported Event|Regimen A|Vinorelbine/cyclophosphamide (VC) + bevacizumab
249015|NCT01222689|B1|Baseline|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib by mouth (PO) every day (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249016|NCT01222689|P1|Participant Flow|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249017|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249018|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249019|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249063|NCT01222117|P8|Participant Flow|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
298126|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
249020|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249021|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249022|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249023|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249024|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249025|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249026|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249027|NCT01222689|E1|Reported Event|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given PO
selumetinib: Given PO
laboratory biomarker analysis: Correlative studies"
249028|NCT01222585|B1|Baseline|Treatment|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
249029|NCT01222585|P1|Participant Flow|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
249030|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
249031|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
249032|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
249033|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
249034|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
249035|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
249036|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
249037|NCT01222585|E1|Reported Event|Treatment|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
249038|NCT01222572|B1|Baseline|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy
Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
249039|NCT01222572|P3|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 3)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 46 Gy; Stereotactic Boost to Primary: 20 Gy; Total Dose to Primary: 66 Gy
Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
249040|NCT01222572|P2|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 2)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 50 Gy; Stereotactic Boost to Primary: 15 Gy; Total Dose to Primary: 65 Gy
Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
249064|NCT01222117|P7|Participant Flow|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249041|NCT01222572|P1|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy
Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
249042|NCT01222572|O1|Outcome|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy
Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
249043|NCT01222572|E1|Reported Event|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy
Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
249044|NCT01222195|B1|Baseline|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
249045|NCT01222195|P1|Participant Flow|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
249046|NCT01222195|O1|Outcome|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
249047|NCT01222195|E1|Reported Event|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
249048|NCT01222117|B12|Baseline|Total|Total of all reporting groups
249049|NCT01222117|B11|Baseline|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249050|NCT01222117|B10|Baseline|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249051|NCT01222117|B9|Baseline|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249052|NCT01222117|B8|Baseline|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249053|NCT01222117|B7|Baseline|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249054|NCT01222117|B6|Baseline|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
Placebo: Normal saline for injection at the same volume as the plasminogen activator."
249055|NCT01222117|B5|Baseline|Plasminogen Activator Blinded Group E|"PA administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
249056|NCT01222117|B4|Baseline|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249057|NCT01222117|B3|Baseline|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection"
249058|NCT01222117|B2|Baseline|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249059|NCT01222117|B1|Baseline|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection"
249060|NCT01222117|P11|Participant Flow|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249061|NCT01222117|P10|Participant Flow|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249062|NCT01222117|P9|Participant Flow|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
298127|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
249065|NCT01222117|P6|Participant Flow|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
Placebo: Normal saline for injection at the same volume as the plasminogen activator."
249066|NCT01222117|P5|Participant Flow|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
249067|NCT01222117|P4|Participant Flow|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249068|NCT01222117|P3|Participant Flow|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection"
249069|NCT01222117|P2|Participant Flow|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249070|NCT01222117|P1|Participant Flow|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection"
249071|NCT01222117|O11|Outcome|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249072|NCT01222117|O10|Outcome|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249073|NCT01222117|O9|Outcome|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249074|NCT01222117|O8|Outcome|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249075|NCT01222117|O7|Outcome|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249076|NCT01222117|O6|Outcome|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
Placebo: Normal saline for injection at the same volume as the plasminogen activator."
249077|NCT01222117|O5|Outcome|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
249078|NCT01222117|O4|Outcome|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249079|NCT01222117|O3|Outcome|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection"
249080|NCT01222117|O2|Outcome|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249081|NCT01222117|O1|Outcome|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection"
249082|NCT01222117|O11|Outcome|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249083|NCT01222117|O10|Outcome|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249084|NCT01222117|O9|Outcome|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249085|NCT01222117|O8|Outcome|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249086|NCT01222117|O7|Outcome|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249087|NCT01222117|O6|Outcome|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
Placebo: Normal saline for injection at the same volume as the plasminogen activator."
249088|NCT01222117|O5|Outcome|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
249089|NCT01222117|O4|Outcome|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249090|NCT01222117|O3|Outcome|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection"
249091|NCT01222117|O2|Outcome|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249092|NCT01222117|O1|Outcome|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection"
249093|NCT01222117|E11|Reported Event|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249094|NCT01222117|E10|Reported Event|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249095|NCT01222117|E9|Reported Event|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection"
249096|NCT01222117|E8|Reported Event|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249097|NCT01222117|E7|Reported Event|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249098|NCT01222117|E6|Reported Event|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
Placebo: Normal saline for injection at the same volume as the plasminogen activator."
249099|NCT01222117|E5|Reported Event|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
249100|NCT01222117|E4|Reported Event|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249101|NCT01222117|E3|Reported Event|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection"
249102|NCT01222117|E2|Reported Event|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection"
249103|NCT01222117|E1|Reported Event|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection"
249104|NCT01222104|B1|Baseline|All Participants|
249105|NCT01222104|P1|Participant Flow|All Participants|
249106|NCT01222104|O1|Outcome|Participants With Deployment|Participants with successful or attempted Angio-Seal deployments
249107|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
249108|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
249109|NCT01222104|O1|Outcome|All Participants|
249110|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
249111|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
249112|NCT01222104|O1|Outcome|All Participants With Deployments and Readable Angiograms|
249113|NCT01222104|O1|Outcome|All Participants|All enrolled participants
249114|NCT01222104|O1|Outcome|All Participants|
249115|NCT01222104|O1|Outcome|Angio-Seal|Secondary outcome reported in subjects with successful Angio-Seal deployment which achieved hemostasis by device.
249116|NCT01222104|O1|Outcome|Angio -Seal|Angio-Seal attempted and/or deployed group
249117|NCT01222104|E1|Reported Event|All Participants|
249118|NCT01222078|B1|Baseline|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249119|NCT01222078|P1|Participant Flow|Otelixizumab|Participant received a single dose of otelixizumab intravenous (IV) infusions each given over a 30 minute period on 8 consecutive days in order: 0.1 milligrams (mg), 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before start of infusion (SOI), 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249120|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249121|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249122|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249173|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
249123|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249124|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249125|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249126|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249127|NCT01222078|O1|Outcome|Overall Study Arm|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249128|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249129|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249130|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249131|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249132|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249133|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249134|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249135|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249174|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
249825|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
249136|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249137|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249138|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249139|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249140|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249141|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249142|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249143|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249144|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249145|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249146|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249147|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249148|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249175|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 (serving as a reference point) and day 16 (serving as a test point), and 60 mg subcutaneous dose of Denosumab on day 2
250641|NCT01217112|B1|Baseline|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
249149|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249150|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249151|NCT01222078|E1|Reported Event|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
249152|NCT01221948|B1|Baseline|Deep Brain Stimulation|"Vercise (TM) Rechargeable Deep Brain Stimulation System
Deep Brain Stimulation: Rechargeable Deep Brain Stimulation System"
249153|NCT01221948|P1|Participant Flow|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
249154|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
249155|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
249156|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
249157|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
249158|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
249159|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
249160|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
249161|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
249162|NCT01221948|E1|Reported Event|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
249163|NCT01221753|B1|Baseline|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
249164|NCT01221753|P1|Participant Flow|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
249165|NCT01221753|O1|Outcome|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
249166|NCT01221753|O1|Outcome|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
249167|NCT01221753|E1|Reported Event|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
249168|NCT01221727|B3|Baseline|Total|Total of all reporting groups
249169|NCT01221727|B2|Baseline|Midazolam Only|2 mg oral dose of Midazolam on Day 1 and Day 16. Out of 9 subjects enrolled and randomized, 8 subjects received investigation product.
249170|NCT01221727|B1|Baseline|Midazolam With Denosumab|2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2. Out of 21 subjects enrolled and randomized, 19 subjects received investigation product.
249171|NCT01221727|P2|Participant Flow|Midazolam Only|2 mg oral dose of Midazolam on Day 1 and Day 16.
249172|NCT01221727|P1|Participant Flow|Midazolam With Denosumab|2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2
250642|NCT01217112|P5|Participant Flow|Placebo|Contains excipients only
249176|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
249177|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
249178|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
249179|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
249180|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
249181|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16 , and 60 mg subcutaneous dose of Denosumab on day 2
249182|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
249183|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 (serving as a reference point) and day 16 (serving as a test point), and 60 mg subcutaneous dose of Denosumab on day 2
249184|NCT01221727|E6|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 16|
249185|NCT01221727|E5|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 2-15|
249186|NCT01221727|E4|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 1|
249187|NCT01221727|E3|Reported Event|Midazolam With Denosumab Group With Midazolam 2mg on Day 16|
249188|NCT01221727|E2|Reported Event|Midazolam With Denosumab Group With Denosumab 60mg on Day 2-15|
249189|NCT01221727|E1|Reported Event|Midazolam With Denosumab Group With Midazolam 2mg on Day 1|
249190|NCT01221623|B3|Baseline|Total|Total of all reporting groups
249191|NCT01221623|B2|Baseline|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249192|NCT01221623|B1|Baseline|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249193|NCT01221623|P2|Participant Flow|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249194|NCT01221623|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249195|NCT01221623|O2|Outcome|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249196|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249197|NCT01221623|O2|Outcome|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249198|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249199|NCT01221623|O2|Outcome|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249200|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249201|NCT01221623|O2|Outcome|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249202|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249203|NCT01221623|O2|Outcome|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249204|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249205|NCT01221623|O2|Outcome|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249206|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249207|NCT01221623|O2|Outcome|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249208|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249209|NCT01221623|O2|Outcome|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249210|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249211|NCT01221623|O2|Outcome|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249212|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249213|NCT01221623|E2|Reported Event|Placebo|"Placebo
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249214|NCT01221623|E1|Reported Event|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249215|NCT01221597|B3|Baseline|Total|Total of all reporting groups
249216|NCT01221597|B2|Baseline|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249217|NCT01221597|B1|Baseline|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249218|NCT01221597|P2|Participant Flow|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249219|NCT01221597|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249323|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249324|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249220|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249221|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249222|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249223|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249224|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249225|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249226|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249227|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249228|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249229|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249230|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249231|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249232|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249233|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249234|NCT01221597|O2|Outcome|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249235|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249236|NCT01221597|O2|Outcome|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249237|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249238|NCT01221597|E2|Reported Event|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
249239|NCT01221597|E1|Reported Event|AA4500|"collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
249240|NCT01221441|B3|Baseline|Total|Total of all reporting groups
249241|NCT01221441|B2|Baseline|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249242|NCT01221441|B1|Baseline|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249243|NCT01221441|P2|Participant Flow|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249244|NCT01221441|P1|Participant Flow|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249245|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249246|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249247|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249248|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249249|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249250|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249251|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249252|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249253|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249254|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249255|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249256|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249257|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249258|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249259|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249260|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249261|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249262|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249263|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249264|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249265|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249266|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249267|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249268|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249269|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249270|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249271|NCT01221441|E2|Reported Event|Placebo Control|"Normal Saline injection
Normal Saline: Single intraarticular injection of normal saline as a placebo control"
249272|NCT01221441|E1|Reported Event|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)
TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
249273|NCT01221363|B3|Baseline|Total|Total of all reporting groups
249274|NCT01221363|B2|Baseline|Control Group|No intervention control group
249325|NCT01221350|E2|Reported Event|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249326|NCT01221350|E1|Reported Event|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249275|NCT01221363|B1|Baseline|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.
Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
249276|NCT01221363|P2|Participant Flow|Control Group|No intervention control group
249277|NCT01221363|P1|Participant Flow|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.
Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
249278|NCT01221363|O2|Outcome|Control Group|No intervention control group
249279|NCT01221363|O1|Outcome|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.
Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
249280|NCT01221363|O2|Outcome|Control Group|No intervention control group
249281|NCT01221363|O1|Outcome|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.
Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
249282|NCT01221363|E2|Reported Event|Control Group|No intervention control group
249283|NCT01221363|E1|Reported Event|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.
Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
249284|NCT01221350|B3|Baseline|Total|Total of all reporting groups
249285|NCT01221350|B2|Baseline|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
249286|NCT01221350|B1|Baseline|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
249287|NCT01221350|P2|Participant Flow|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249288|NCT01221350|P1|Participant Flow|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249289|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249290|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249291|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249292|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249293|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249294|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249295|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249296|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249297|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
249298|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
249299|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249300|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249301|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249302|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249303|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249304|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249305|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249306|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249307|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249308|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249309|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249310|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249311|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249312|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249313|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249314|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249315|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
249316|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
249317|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249318|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249319|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
249320|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
249321|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
249322|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
249328|NCT01221311|B2|Baseline|Plastic Stent|Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria.
249329|NCT01221311|B1|Baseline|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
249330|NCT01221311|P2|Participant Flow|Plastic Stent|"Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).
Plastic Stent: Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal"
249331|NCT01221311|P1|Participant Flow|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
249332|NCT01221311|O2|Outcome|Plastic Stent|"Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).
Plastic Stent: Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal"
249333|NCT01221311|O1|Outcome|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
249334|NCT01221311|E2|Reported Event|Plastic Stent|Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria.
249335|NCT01221311|E1|Reported Event|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
249336|NCT01221298|B1|Baseline|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
249337|NCT01221298|P1|Participant Flow|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
249338|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
249339|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
249340|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
249341|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
249342|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
249343|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
249344|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
249345|NCT01221298|E1|Reported Event|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
250777|NCT01217112|O5|Outcome|Placebo|Contains excipients only
249346|NCT01221285|B1|Baseline|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.
249347|NCT01221285|P1|Participant Flow|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
249348|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
249349|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
249350|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
249351|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
249352|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
249353|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
249354|NCT01221285|E1|Reported Event|Experimental: German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
249355|NCT01221272|B1|Baseline|All Participants|"Baseline characteristics were analyzed as a single group (Safety Analysis Set). All participants were assigned to complete the same treatment periods in the same manner.
Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249356|NCT01221272|P2|Participant Flow|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249357|NCT01221272|P1|Participant Flow|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) study.
Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249358|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249359|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249360|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249361|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249362|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249363|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249826|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249364|NCT01221272|O2|Outcome|Placebo|Placebo treatment period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
249365|NCT01221272|O1|Outcome|Ranolazine|Ranolazine treatment period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
249366|NCT01221272|O2|Outcome|Placebo|Placebo treatment period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
249367|NCT01221272|O1|Outcome|Ranolazine|Ranolazine treatment period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
249368|NCT01221272|E3|Reported Event|Onset at Any Time Following Ranolazine|"This reporting group includes participants dosed with ranolazine and their events with onset at any time following ranolazine treatment.
Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249369|NCT01221272|E2|Reported Event|Onset Following Placebo|"This reporting group includes participants dosed with placebo and their events for which the last dosed treatment was placebo, ie, events with onset during the placebo treatment period or during post-placebo treatment period follow-up.
Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249370|NCT01221272|E1|Reported Event|Onset Following Ranolazine|"This reporting group includes participants dosed with ranolazine and their events for which the last dosed treatment was ranolazine, ie, events with onset during the ranolazine treatment period or during post-ranolazine treatment period follow-up.
Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
249371|NCT01221090|B5|Baseline|Total|Total of all reporting groups
249372|NCT01221090|B4|Baseline|Control|Usual Care
249373|NCT01221090|B3|Baseline|PDA/CDSMP|"Combined intervention
PDA/CDSMP : Combined technology and education"
249374|NCT01221090|B2|Baseline|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)
PDA : Technological assistance"
249375|NCT01221090|B1|Baseline|CDSMP|"6-week educational classes
CDSMP : 6-week classes"
249376|NCT01221090|P4|Participant Flow|Control|Usual Care
249377|NCT01221090|P3|Participant Flow|PDA/CDSMP|"Combined intervention
PDA/CDSMP : Combined technology and education"
249378|NCT01221090|P2|Participant Flow|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)
PDA : Technological assistance"
249379|NCT01221090|P1|Participant Flow|CDSMP|"6-week educational classes
CDSMP : 6-week classes"
249380|NCT01221090|O4|Outcome|Control|Usual Care
249381|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention
PDA/CDSMP : Combined technology and education"
249382|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)
PDA : Technological assistance"
249383|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes
CDSMP : 6-week classes"
249384|NCT01221090|O4|Outcome|Control|Usual Care
249385|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention
PDA/CDSMP : Combined technology and education"
249386|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)
PDA : Technological assistance"
249387|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes
CDSMP : 6-week classes"
249388|NCT01221090|O4|Outcome|Control|Usual Care
249389|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention
PDA/CDSMP : Combined technology and education"
249390|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)
PDA : Technological assistance"
249391|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes
CDSMP : 6-week classes"
249392|NCT01221090|O4|Outcome|Control|Usual Care
249393|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention
PDA/CDSMP : Combined technology and education"
249394|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)
PDA : Technological assistance"
249395|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes
CDSMP : 6-week classes"
249396|NCT01221090|O4|Outcome|Control|Usual Care
249397|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention
PDA/CDSMP : Combined technology and education"
249398|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)
PDA : Technological assistance"
249399|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes
CDSMP : 6-week classes"
249400|NCT01221090|E4|Reported Event|Control|Usual Care
249401|NCT01221090|E3|Reported Event|PDA/CDSMP|"Combined intervention
PDA/CDSMP : Combined technology and education"
249402|NCT01221090|E2|Reported Event|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)
PDA : Technological assistance"
249403|NCT01221090|E1|Reported Event|CDSMP|"6-week educational classes
CDSMP : 6-week classes"
249404|NCT01220869|B1|Baseline|Degarelix|Degarelix 240/80 mg dosing regimen (240 mg is the initiation dose, the 80 mg is the maintenance dose)
249443|NCT01220466|P2|Participant Flow|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
298128|NCT00150618|O5|Outcome|Placebo|once daily
249405|NCT01220869|P1|Participant Flow|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
249406|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
249407|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
249408|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
249409|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
249410|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
249411|NCT01220869|E1|Reported Event|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
249412|NCT01220739|B3|Baseline|Total|Total of all reporting groups
249413|NCT01220739|B2|Baseline|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.
Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
249414|NCT01220739|B1|Baseline|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.
Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
249415|NCT01220739|P2|Participant Flow|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.
Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
249416|NCT01220739|P1|Participant Flow|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.
Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
249417|NCT01220739|O2|Outcome|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.
Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
249418|NCT01220739|O1|Outcome|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.
Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
249419|NCT01220739|O2|Outcome|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.
Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
249470|NCT01220297|B3|Baseline|Total|Total of all reporting groups
298129|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
249420|NCT01220739|O1|Outcome|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.
Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
249421|NCT01220739|E2|Reported Event|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.
Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
249422|NCT01220739|E1|Reported Event|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.
Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
249423|NCT01220609|B1|Baseline|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
249424|NCT01220609|P1|Participant Flow|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
249425|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
249426|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
249427|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
249428|NCT01220609|E1|Reported Event|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
249429|NCT01220557|B3|Baseline|Total|Total of all reporting groups
249430|NCT01220557|B2|Baseline|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
249431|NCT01220557|B1|Baseline|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
249432|NCT01220557|P2|Participant Flow|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
249433|NCT01220557|P1|Participant Flow|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
249434|NCT01220557|O2|Outcome|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
249435|NCT01220557|O1|Outcome|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
249436|NCT01220557|E2|Reported Event|Control Group|"The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
DTTP: The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material."
249437|NCT01220557|E1|Reported Event|PRIMAS Group|"PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
PRIMAS: PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material"
249438|NCT01220466|B4|Baseline|Total|Total of all reporting groups
249439|NCT01220466|B3|Baseline|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
249440|NCT01220466|B2|Baseline|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
249441|NCT01220466|B1|Baseline|Hyperopia With or Without Astigmatism|"Hyperopia with and without astigmatism with MRSE up to
+9.00 D, with cylinder between 0.00 and +6.00 D."
249442|NCT01220466|P3|Participant Flow|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
250635|NCT01217229|E1|Reported Event|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
249444|NCT01220466|P1|Participant Flow|Hyperopia With or Without Astigmatism|"Hyperopia with and without astigmatism with MRSE up to
+9.00 D, with cylinder between 0.00 and +6.00 D."
249445|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
249446|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
249447|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
249448|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
249449|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
249450|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
249451|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
249452|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
249453|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
249454|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
249455|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
249456|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
249457|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
249458|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
249459|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
249460|NCT01220466|E3|Reported Event|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
249461|NCT01220466|E2|Reported Event|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
249462|NCT01220466|E1|Reported Event|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
249463|NCT01220401|B1|Baseline|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.
exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
249464|NCT01220401|P1|Participant Flow|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.
exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
249465|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.
exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.
Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
249466|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.
exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.
Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
249467|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.
exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.
Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
249468|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.
exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.
Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
249469|NCT01220401|E1|Reported Event|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.
exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
249471|NCT01220297|B2|Baseline|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
249472|NCT01220297|B1|Baseline|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
249473|NCT01220297|P1|Participant Flow|Graft-vs-Host Disease (GvHD) Prophlyaxis|Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative
249474|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
249475|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
249476|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
249477|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
249478|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
249479|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
249480|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
249481|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
249482|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
249483|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
249484|NCT01220297|E2|Reported Event|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
249485|NCT01220297|E1|Reported Event|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
249486|NCT01220180|B4|Baseline|Total|Total of all reporting groups
249487|NCT01220180|B3|Baseline|Pregabalin: Fibromyalgia|Pregabalin capsules administered orally starting with a dose of 300 to 450 mg/day in adult participants with fibromyalgia.
249488|NCT01220180|B2|Baseline|Pregabalin: Neuropathic Pain|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with Neuropathic pain (NeP).
249489|NCT01220180|B1|Baseline|Pregabalin: Epilepsy|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy.
249490|NCT01220180|P1|Participant Flow|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 milligram per day (mg/day) which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249491|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249492|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249493|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249494|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249495|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249496|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249827|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
249497|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249498|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249499|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249500|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249501|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249502|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249503|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249504|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249505|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249506|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249507|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249508|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249509|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249510|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249511|NCT01220180|E1|Reported Event|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
249512|NCT01220128|B8|Baseline|Total|Total of all reporting groups
249513|NCT01220128|B7|Baseline|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249514|NCT01220128|B6|Baseline|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249515|NCT01220128|B5|Baseline|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249516|NCT01220128|B4|Baseline|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249517|NCT01220128|B3|Baseline|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249518|NCT01220128|B2|Baseline|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249519|NCT01220128|B1|Baseline|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249779|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.
Sevoflurane : 1.4 to 2.5% Sevoflurane"
249520|NCT01220128|P7|Participant Flow|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249521|NCT01220128|P6|Participant Flow|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249522|NCT01220128|P5|Participant Flow|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249523|NCT01220128|P4|Participant Flow|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249524|NCT01220128|P3|Participant Flow|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249525|NCT01220128|P2|Participant Flow|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249526|NCT01220128|P1|Participant Flow|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249527|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249528|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249529|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249530|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249531|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249532|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249533|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249534|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249535|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249536|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249537|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249538|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249539|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249540|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249541|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249542|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249543|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249544|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249545|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249546|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249547|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249548|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249549|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249550|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249551|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249552|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249553|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249554|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249555|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249556|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249557|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249558|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249559|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249560|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249561|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249562|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249563|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249564|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249565|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249566|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249567|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249568|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249569|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249570|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249571|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249572|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249573|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249574|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249575|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249576|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249577|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249578|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249579|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249580|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249581|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249582|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249583|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249584|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249585|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249586|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249587|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249588|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249589|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249828|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
249590|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249591|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249592|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249593|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249594|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249595|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249596|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249597|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249598|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249599|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249600|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249601|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249602|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249603|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249604|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249605|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249606|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249607|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249608|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249609|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249610|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249611|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249612|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
250636|NCT01217112|B6|Baseline|Total|Total of all reporting groups
249613|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249614|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249615|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249616|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249617|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249618|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249619|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249620|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249621|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249622|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249623|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249624|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249625|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249626|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249627|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249628|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249629|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249630|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249631|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249632|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249633|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249634|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249635|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249636|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249637|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249638|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249639|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249640|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249641|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249642|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249643|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249644|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249645|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249646|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249647|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249648|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249649|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249650|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249651|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249652|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249653|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249654|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249655|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249656|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249657|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249658|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249659|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249829|NCT01219855|E4|Reported Event|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
249660|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249661|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249662|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249663|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249664|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249665|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249666|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249667|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249668|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249669|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249670|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249671|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249672|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249673|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249674|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249675|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249676|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249677|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249678|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249679|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249680|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249681|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249682|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
250637|NCT01217112|B5|Baseline|Placebo|Contains excipients only
249683|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249684|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249685|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249686|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249687|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249688|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249689|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249690|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249691|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249692|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249693|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249694|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249695|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249696|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249697|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249698|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249699|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024AI and intravenous chemotherapy.
249700|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249701|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249702|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249703|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249704|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249705|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249706|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024AI and intravenous chemotherapy.
249707|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249708|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249709|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249710|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249711|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249712|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249713|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249714|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249715|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249716|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249717|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249718|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249719|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249720|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249721|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249722|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule
249723|NCT01220128|E7|Reported Event|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249724|NCT01220128|E6|Reported Event|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
249725|NCT01220128|E5|Reported Event|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249726|NCT01220128|E4|Reported Event|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249727|NCT01220128|E3|Reported Event|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
249728|NCT01220128|E2|Reported Event|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
249729|NCT01220128|E1|Reported Event|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
249730|NCT01219985|B1|Baseline|Investigation Arm|Patients included in the trial. n=50
249731|NCT01219985|P1|Participant Flow|Investigation Arm|Patients definitely included in the trial. All these patients underwent non-gated and gated PET/CT as well as hepatic surgery. In addition, histological analysis of the resected lesions were also obtained.
249732|NCT01219985|O1|Outcome|SUVmax Study|SUVmax measurement for each lesion in Ungated and CT-Based PET images. SUVmax was obtained automatically in a volume of interest encompassing the entire lesion
249733|NCT01219985|O2|Outcome|CT-Based Per-lesion Sensitivity|CT-Based PET images results were compared with pathological analyses
249734|NCT01219985|O1|Outcome|Ungated Per-lesion Sensitivity|Ungated PET images results were compared with pathological analyses
249735|NCT01219985|E1|Reported Event|Investigation Arm|Patients included in the trial. n=50
249736|NCT01219933|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249737|NCT01219933|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) once every 4 weeks and methotrexate (MTX) 7.5 to 25 mg per week (mg/week; per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received an oral glucocorticoid (GC; no product/dose limitation) until low disease activity (LDA; defined as Disease Activity Score Based on 28-Joint Count and C-reactive protein [DAS28-CRP] less than or equal to [≤]3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to methylprednisolone (MP) tablets, by mouth (PO). MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be greater than or equal to [≥]1 mg and ≤20 mg per day [mg/day]), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment
249738|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249739|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249740|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249741|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249742|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249743|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249780|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.
Desflurane : 5.4 to 7.4% desflurane"
249830|NCT01219855|E3|Reported Event|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
249744|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249745|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249746|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249747|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249748|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249749|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249750|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249751|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249752|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249753|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249823|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
249754|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249755|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249756|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249757|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249758|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249759|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249760|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249761|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249762|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249763|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249824|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249764|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249765|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249766|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249767|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249768|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249769|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249770|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249771|NCT01219933|E2|Reported Event|Interventional Phase|All participants who maintained LDA from V2 to V3 were included in the interventional phase for reduction of GC. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
249772|NCT01219933|E1|Reported Event|Noninterventional Phase|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week according to local standard of care and at the investigator's discretion (or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months.
249773|NCT01219881|B3|Baseline|Total|Total of all reporting groups
249774|NCT01219881|B2|Baseline|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.
Desflurane : 5.4 to 7.4% desflurane"
249775|NCT01219881|B1|Baseline|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.
Sevoflurane : 1.4 to 2.5% Sevoflurane"
249776|NCT01219881|P2|Participant Flow|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.
Sevoflurane : 1.4 to 2.5% Sevoflurane"
249777|NCT01219881|P1|Participant Flow|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.
Desflurane : 5.4 to 7.4% desflurane"
249778|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.
Desflurane : 5.4 to 7.4% desflurane"
249781|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.
Sevoflurane : 1.4 to 2.5% Sevoflurane"
249782|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.
Desflurane : 5.4 to 7.4% desflurane"
249783|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.
Sevoflurane : 1.4 to 2.5% Sevoflurane"
249784|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.
Desflurane : 5.4 to 7.4% desflurane"
249785|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.
Sevoflurane : 1.4 to 2.5% Sevoflurane"
249786|NCT01219881|E2|Reported Event|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.
Desflurane : 5.4 to 7.4% desflurane"
249787|NCT01219881|E1|Reported Event|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.
Sevoflurane : 1.4 to 2.5% Sevoflurane"
249788|NCT01219855|B6|Baseline|Total|Total of all reporting groups
249789|NCT01219855|B5|Baseline|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249790|NCT01219855|B4|Baseline|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
249791|NCT01219855|B3|Baseline|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249792|NCT01219855|B2|Baseline|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
249793|NCT01219855|B1|Baseline|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
249794|NCT01219855|P5|Participant Flow|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249795|NCT01219855|P4|Participant Flow|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
249796|NCT01219855|P3|Participant Flow|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249797|NCT01219855|P2|Participant Flow|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
249798|NCT01219855|P1|Participant Flow|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
249799|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249800|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
249801|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249802|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
249803|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
249804|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249805|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
249806|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249807|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
249808|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
249809|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249810|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
249811|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249812|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
249813|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
249814|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249815|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
249816|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249817|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
249818|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
249819|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249820|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
249821|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249822|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
249851|NCT01219673|B9|Baseline|Total|Total of all reporting groups
249831|NCT01219855|E2|Reported Event|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
249832|NCT01219855|E1|Reported Event|Cohorts 1,2: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
249833|NCT01219777|B1|Baseline|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.
Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.
Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.
Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
249834|NCT01219777|P1|Participant Flow|Carboplatin + Weekly Paclitaxel and Bevacizumab|"Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days.
Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.
Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.
Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
249835|NCT01219777|O1|Outcome|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.
Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.
Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.
Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
249836|NCT01219777|O1|Outcome|Arm I|"Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days.
Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.
Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.
Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
249837|NCT01219777|E1|Reported Event|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.
Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.
Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.
Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
249838|NCT01219738|B1|Baseline|Asthma|"asthmatic subject received different doses of inhaled budesonide
Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
Budesonide: A single dose of 1440ug of the budesonide from DPI.
Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
Placebo: A single inhaled dose of placebo from a DPI."
249839|NCT01219738|P1|Participant Flow|All Study Participants|"asthmatic subject received different doses of inhaled budesonide
Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
Budesonide: A single dose of 1440ug of the budesonide from DPI.
Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
Placebo: A single inhaled dose of placebo from a DPI."
249840|NCT01219738|O5|Outcome|Placebo|A single inhaled dose of placebo from a DPI
249841|NCT01219738|O4|Outcome|720ug of Budesonide 4 Times|Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
249842|NCT01219738|O3|Outcome|Budesonide 1440 ug|Budesonide: A single inhaled dose of 1440ug budesonide from a DPI.
249843|NCT01219738|O2|Outcome|Budesonide 720 ug|Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
249844|NCT01219738|O1|Outcome|Budesonide 360 ug|Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
249845|NCT01219738|O5|Outcome|Placebo|Placebo: A single inhaled dose of placebo from a DPI
249846|NCT01219738|O4|Outcome|Budesonide 720ug 4 Times|Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
249847|NCT01219738|O3|Outcome|Budesonide 1440ug|Budesonide: A single dose of 1440ug of the budesonide from DPI.
249848|NCT01219738|O2|Outcome|Budesonide 720ug|Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
249849|NCT01219738|O1|Outcome|Budesonide 360ug|Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
249850|NCT01219738|E1|Reported Event|All Study Participants|Budesonide:was given in different doses
249852|NCT01219673|B8|Baseline|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Minocycline: 100 mg by mouth twice a day.
Bupropion: 100 mg by mouth twice a day."
249853|NCT01219673|B7|Baseline|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
Minocycline: 100 mg by mouth twice a day.
Bupropion: 100 mg by mouth twice a day."
249854|NCT01219673|B6|Baseline|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.
Bupropion 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Bupropion: 100 mg by mouth twice a day."
249855|NCT01219673|B5|Baseline|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Minocycline: 100 mg by mouth twice a day."
249856|NCT01219673|B4|Baseline|Bupropion|"Bupropion 100 mg by mouth two times a day.
Bupropion: 100 mg by mouth twice a day."
249857|NCT01219673|B3|Baseline|Minocycline|"Minocycline 100 mg by muth two times a day.
Minocycline: 100 mg by mouth twice a day."
249858|NCT01219673|B2|Baseline|Armodafinil|"Armodafinil 150 mg by mouth once a day.
Armodafinil: 150 mg by mouth once a day."
249859|NCT01219673|B1|Baseline|Placebo|"Placebo by mouth 2 times every day.
Placebo: 1 by mouth twice a day."
249860|NCT01219673|P8|Participant Flow|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Minocycline: 100 mg by mouth twice a day.
Bupropion: 100 mg by mouth twice a day."
249861|NCT01219673|P7|Participant Flow|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
Minocycline: 100 mg by mouth twice a day.
Bupropion: 100 mg by mouth twice a day."
249862|NCT01219673|P6|Participant Flow|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.
Bupropion 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Bupropion: 100 mg by mouth twice a day."
249863|NCT01219673|P5|Participant Flow|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Minocycline: 100 mg by mouth twice a day."
249864|NCT01219673|P4|Participant Flow|Bupropion|"Bupropion 100 mg by mouth two times a day.
Bupropion: 100 mg by mouth twice a day."
249865|NCT01219673|P3|Participant Flow|Minocycline|"Minocycline 100 mg by muth two times a day.
Minocycline: 100 mg by mouth twice a day."
249866|NCT01219673|P2|Participant Flow|Armodafinil|"Armodafinil 150 mg by mouth once a day.
Armodafinil: 150 mg by mouth once a day."
249867|NCT01219673|P1|Participant Flow|Placebo|"Placebo by mouth 2 times every day.
Placebo: 1 by mouth twice a day."
249868|NCT01219673|O8|Outcome|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Minocycline: 100 mg by mouth twice a day.
Bupropion: 100 mg by mouth twice a day."
249869|NCT01219673|O7|Outcome|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
Minocycline: 100 mg by mouth twice a day.
Bupropion: 100 mg by mouth twice a day."
249870|NCT01219673|O6|Outcome|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.
Bupropion 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Bupropion: 100 mg by mouth twice a day."
249871|NCT01219673|O5|Outcome|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Minocycline: 100 mg by mouth twice a day."
249872|NCT01219673|O4|Outcome|Bupropion|"Bupropion 100 mg by mouth two times a day.
Bupropion: 100 mg by mouth twice a day."
249873|NCT01219673|O3|Outcome|Minocycline|"Minocycline 100 mg by muth two times a day.
Minocycline: 100 mg by mouth twice a day."
249874|NCT01219673|O2|Outcome|Armodafinil|"Armodafinil 150 mg by mouth once a day.
Armodafinil: 150 mg by mouth once a day."
249875|NCT01219673|O1|Outcome|Placebo|"Placebo by mouth 2 times every day.
Placebo: 1 by mouth twice a day."
249876|NCT01219673|E8|Reported Event|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Minocycline: 100 mg by mouth twice a day.
Bupropion: 100 mg by mouth twice a day."
249877|NCT01219673|E7|Reported Event|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
Minocycline: 100 mg by mouth twice a day.
Bupropion: 100 mg by mouth twice a day."
249878|NCT01219673|E6|Reported Event|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.
Bupropion 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Bupropion: 100 mg by mouth twice a day."
249879|NCT01219673|E5|Reported Event|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by mouth two times a day.
Armodafinil: 150 mg by mouth once a day.
Minocycline: 100 mg by mouth twice a day."
249880|NCT01219673|E4|Reported Event|Bupropion|"Bupropion 100 mg by mouth two times a day.
Bupropion: 100 mg by mouth twice a day."
249881|NCT01219673|E3|Reported Event|Minocycline|"Minocycline 100 mg by muth two times a day.
Minocycline: 100 mg by mouth twice a day."
249882|NCT01219673|E2|Reported Event|Armodafinil|"Armodafinil 150 mg by mouth once a day.
Armodafinil: 150 mg by mouth once a day."
249883|NCT01219673|E1|Reported Event|Placebo|"Placebo by mouth 2 times every day.
Placebo: 1 by mouth twice a day."
249884|NCT01218997|B3|Baseline|Total|Total of all reporting groups
249885|NCT01218997|B2|Baseline|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
249886|NCT01218997|B1|Baseline|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
249887|NCT01218997|P2|Participant Flow|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
249888|NCT01218997|P1|Participant Flow|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
249889|NCT01218997|O2|Outcome|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
249890|NCT01218997|O1|Outcome|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
249891|NCT01218997|E2|Reported Event|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
249892|NCT01218997|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
249893|NCT01218984|B4|Baseline|Total|Total of all reporting groups
249894|NCT01218984|B3|Baseline|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
249895|NCT01218984|B2|Baseline|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
249896|NCT01218984|B1|Baseline|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
249897|NCT01218984|P3|Participant Flow|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
249898|NCT01218984|P2|Participant Flow|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
249899|NCT01218984|P1|Participant Flow|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
249900|NCT01218984|O3|Outcome|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
249901|NCT01218984|O2|Outcome|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
249902|NCT01218984|O1|Outcome|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
249903|NCT01218984|E3|Reported Event|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
249904|NCT01218984|E2|Reported Event|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
249905|NCT01218984|E1|Reported Event|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
249906|NCT01218971|B3|Baseline|Total|Total of all reporting groups
249907|NCT01218971|B2|Baseline|Medisorb Naltrexone 190 mg|
249908|NCT01218971|B1|Baseline|Medisorb Naltrexone 380 mg|
249909|NCT01218971|P2|Participant Flow|Medisorb Naltrexone 190 mg|
249910|NCT01218971|P1|Participant Flow|Medisorb Naltrexone 380 mg|
249911|NCT01218971|O2|Outcome|Medisorb Naltrexone 190 mg|
249912|NCT01218971|O1|Outcome|Medisorb Naltrexone 380 mg|
249913|NCT01218971|E6|Reported Event|190mg to 190mg|includes participants who received Medisorb naltrexone 190mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
249914|NCT01218971|E5|Reported Event|Placebo to 190mg|Includes participants who received placebo in the base study but switched to Medisorb naltrexone 190mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
249915|NCT01218971|E4|Reported Event|380mg to 380mg|Includes participants who received Medisorb naltrexone 380mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
249916|NCT01218971|E3|Reported Event|Placebo to 380mg|Includes participants who received placebo in the base study but switched to Medisorb naltrexone 380mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
249917|NCT01218971|E2|Reported Event|Medisorb Naltrexone 190mg--Combined|Includes all participants who received Medisorb naltrexone 190mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
249918|NCT01218971|E1|Reported Event|Medisorb Naltrexone 380mg--Combined|Includes all participants who received Medisorb naltrexone 380mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
249919|NCT01218958|B4|Baseline|Total|Total of all reporting groups
249920|NCT01218958|B3|Baseline|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
249921|NCT01218958|B2|Baseline|Medisorb Naltrexone 380 mg|
249922|NCT01218958|B1|Baseline|Medisorb Naltrexone 190 mg|
249923|NCT01218958|P3|Participant Flow|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
249924|NCT01218958|P2|Participant Flow|Medisorb Naltrexone 380 mg|
249925|NCT01218958|P1|Participant Flow|Medisorb Naltrexone 190 mg|
249926|NCT01218958|O3|Outcome|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
249927|NCT01218958|O2|Outcome|Medisorb Naltrexone 380 mg|
249928|NCT01218958|O1|Outcome|Medisorb Naltrexone 190 mg|
249929|NCT01218958|O3|Outcome|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
249930|NCT01218958|O2|Outcome|Medisorb Naltrexone 380 mg|
249931|NCT01218958|O1|Outcome|Medisorb Naltrexone 190 mg|
249932|NCT01218958|E3|Reported Event|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
249933|NCT01218958|E2|Reported Event|Medisorb Naltrexone 380 mg|
249934|NCT01218958|E1|Reported Event|Medisorb Naltrexone 190 mg|
249935|NCT01218867|B12|Baseline|Total|Total of all reporting groups
249936|NCT01218867|B11|Baseline|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
250034|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250035|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250036|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
250037|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
249937|NCT01218867|B10|Baseline|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249938|NCT01218867|B9|Baseline|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249939|NCT01218867|B8|Baseline|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249940|NCT01218867|B7|Baseline|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249941|NCT01218867|B6|Baseline|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249942|NCT01218867|B5|Baseline|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249943|NCT01218867|B4|Baseline|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249944|NCT01218867|B3|Baseline|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
250331|NCT01218100|E2|Reported Event|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
249945|NCT01218867|B2|Baseline|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249946|NCT01218867|B1|Baseline|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249947|NCT01218867|P11|Participant Flow|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249948|NCT01218867|P10|Participant Flow|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249949|NCT01218867|P9|Participant Flow|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249950|NCT01218867|P8|Participant Flow|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249951|NCT01218867|P7|Participant Flow|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249952|NCT01218867|P6|Participant Flow|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249953|NCT01218867|P5|Participant Flow|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249954|NCT01218867|P4|Participant Flow|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249955|NCT01218867|P3|Participant Flow|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249956|NCT01218867|P2|Participant Flow|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249957|NCT01218867|P1|Participant Flow|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) cluster of differentiation 8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249958|NCT01218867|O11|Outcome|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249959|NCT01218867|O10|Outcome|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249960|NCT01218867|O9|Outcome|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249961|NCT01218867|O8|Outcome|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249962|NCT01218867|O7|Outcome|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249963|NCT01218867|O6|Outcome|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249964|NCT01218867|O5|Outcome|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249965|NCT01218867|O4|Outcome|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249966|NCT01218867|O3|Outcome|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249967|NCT01218867|O2|Outcome|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249968|NCT01218867|O1|Outcome|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2(VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
298130|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
249969|NCT01218867|O11|Outcome|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249970|NCT01218867|O10|Outcome|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249971|NCT01218867|O9|Outcome|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249972|NCT01218867|O8|Outcome|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249973|NCT01218867|O7|Outcome|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249974|NCT01218867|O6|Outcome|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249975|NCT01218867|O5|Outcome|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249976|NCT01218867|O4|Outcome|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
250332|NCT01218100|E1|Reported Event|Placebo|Placebo group - starting dose is placebo
249977|NCT01218867|O3|Outcome|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249978|NCT01218867|O2|Outcome|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249979|NCT01218867|O1|Outcome|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2(VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249980|NCT01218867|O11|Outcome|Cohort 11 - 3x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249981|NCT01218867|O10|Outcome|Cohort 10 - 1x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249982|NCT01218867|O9|Outcome|Cohort 9 - 3x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249983|NCT01218867|O8|Outcome|Cohort 8 - 1x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249984|NCT01218867|O7|Outcome|Cohort 7 - 1x10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
250333|NCT01218087|B3|Baseline|Total|Total of all reporting groups
249985|NCT01218867|O6|Outcome|Cohort 6 - 3x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249986|NCT01218867|O5|Outcome|Cohort 5 - 1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249987|NCT01218867|O4|Outcome|Cohort 4 - 3x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249988|NCT01218867|O3|Outcome|Cohort 3 - 1x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249989|NCT01218867|O2|Outcome|Cohort 2 - 3x10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249990|NCT01218867|O1|Outcome|Cohort 1 - 1x10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249991|NCT01218867|E11|Reported Event|Cohort 11 (3x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249992|NCT01218867|E10|Reported Event|Cohort 10 (1x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
298131|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
249993|NCT01218867|E9|Reported Event|Cohort 9 (3x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249994|NCT01218867|E8|Reported Event|Cohort 8 (1x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249995|NCT01218867|E7|Reported Event|Cohort 7 (1x10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249996|NCT01218867|E6|Reported Event|Cohort 6 (1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249997|NCT01218867|E5|Reported Event|Cohort 5 (1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249998|NCT01218867|E4|Reported Event|Cohort 4 (3x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
249999|NCT01218867|E3|Reported Event|Cohort 3 (1x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
250000|NCT01218867|E2|Reported Event|Cohort 2 (3x10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
250537|NCT01217749|B1|Baseline|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
250001|NCT01218867|E1|Reported Event|Cohort 1 (1x10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
250002|NCT01218802|B3|Baseline|Total|Total of all reporting groups
250003|NCT01218802|B2|Baseline|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks"
250004|NCT01218802|B1|Baseline|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
250005|NCT01218802|P2|Participant Flow|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks"
250006|NCT01218802|P1|Participant Flow|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
250007|NCT01218802|O2|Outcome|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks"
250008|NCT01218802|O1|Outcome|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
250009|NCT01218802|O2|Outcome|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks"
250010|NCT01218802|O1|Outcome|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
250011|NCT01218802|E2|Reported Event|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks"
250012|NCT01218802|E1|Reported Event|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
250013|NCT01218646|B5|Baseline|Total|Total of all reporting groups
250014|NCT01218646|B4|Baseline|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250015|NCT01218646|B3|Baseline|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine
250016|NCT01218646|B2|Baseline|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
250017|NCT01218646|B1|Baseline|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
250018|NCT01218646|P4|Participant Flow|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine.
250019|NCT01218646|P3|Participant Flow|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250020|NCT01218646|P2|Participant Flow|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
250021|NCT01218646|P1|Participant Flow|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
250022|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250023|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250024|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
250025|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
250026|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250027|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250028|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
250029|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
250030|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250031|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250032|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
250033|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
250038|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250039|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250040|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
250041|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
250042|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250043|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250044|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
250045|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
250046|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250047|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250048|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
250049|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
250050|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250051|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250052|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
250053|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
250054|NCT01218646|E4|Reported Event|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
250055|NCT01218646|E3|Reported Event|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine
250056|NCT01218646|E2|Reported Event|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
250057|NCT01218646|E1|Reported Event|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
250058|NCT01218594|B1|Baseline|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
250059|NCT01218594|P1|Participant Flow|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
250060|NCT01218594|O1|Outcome|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
250061|NCT01218594|E1|Reported Event|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
250062|NCT01218477|B5|Baseline|Total|Total of all reporting groups
250063|NCT01218477|B4|Baseline|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then once daily (QD) plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250064|NCT01218477|B3|Baseline|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250065|NCT01218477|B2|Baseline|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), plus BMS-833923, 50 mg, QD), depending on cohort cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250066|NCT01218477|B1|Baseline|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
250067|NCT01218477|P4|Participant Flow|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250068|NCT01218477|P3|Participant Flow|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID), for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250069|NCT01218477|P2|Participant Flow|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg QD
250070|NCT01218477|P1|Participant Flow|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
250071|NCT01218477|O4|Outcome|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days, then once daily (QD), plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250072|NCT01218477|O3|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID|Participants received BMS-833923, 100 mg twice daily (BID), for 7 days, followed by dasatinib, 100/140 mg once daily (QD)
250073|NCT01218477|O2|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD
250074|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
250075|NCT01218477|O4|Outcome|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days, then once daily (QD), plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250076|NCT01218477|O3|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250077|NCT01218477|O2|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD
250078|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
250079|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
250080|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
250081|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
250082|NCT01218477|E4|Reported Event|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250083|NCT01218477|E3|Reported Event|Dasatanib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatanib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250084|NCT01218477|E2|Reported Event|Dasatanib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatanib, 100/140 mg once daily (QD), as oral tablets plus BMS-833923, 50 mg, QD (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250085|NCT01218477|E1|Reported Event|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD) (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
250086|NCT01218438|B1|Baseline|Study Epochs 1-4|"EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250087|NCT01218438|P1|Participant Flow|Study Participants|"EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250088|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250538|NCT01217749|P3|Participant Flow|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
250089|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250090|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250091|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250092|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250093|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250094|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250095|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250096|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250097|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250098|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250099|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250100|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250101|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250102|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250103|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250104|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250105|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250106|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250107|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250108|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250109|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250110|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250111|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250112|NCT01218438|O6|Outcome|CHANGE END EPOCH 1 TO END EPOCH 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250113|NCT01218438|O5|Outcome|CHANGE END EPOCH 1 TO END EPOCH 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250114|NCT01218438|O4|Outcome|END OF STUDY EPOCH 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250115|NCT01218438|O3|Outcome|END OF STUDY EPOCH 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250540|NCT01217749|P1|Participant Flow|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
250116|NCT01218438|O2|Outcome|END OF STUDY EPOCH 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250117|NCT01218438|O1|Outcome|START OF STUDY EPOCH 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250118|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250119|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250120|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250121|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250122|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250123|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250124|NCT01218438|O6|Outcome|Change End Epoch 1 to End Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250125|NCT01218438|O5|Outcome|Change End Epoch 1 to End Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250126|NCT01218438|O4|Outcome|End of Study Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
250127|NCT01218438|O3|Outcome|End of Study Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
250128|NCT01218438|O2|Outcome|End of Study Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250129|NCT01218438|O1|Outcome|Start of Study Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250130|NCT01218438|O2|Outcome|Subcutaneous 20%|
250131|NCT01218438|O1|Outcome|Intravenous 10%|
250132|NCT01218438|O2|Outcome|Subcutaneous 20%|
250133|NCT01218438|O1|Outcome|Intravenous 10%|
250134|NCT01218438|O2|Outcome|Subcutaneous 20%|
250135|NCT01218438|O1|Outcome|Intravenous 10%|
250136|NCT01218438|O2|Outcome|Subcutaneous 20%|
250137|NCT01218438|O1|Outcome|Intravenous 10%|
250138|NCT01218438|O2|Outcome|Subcutaneous 20%|
250139|NCT01218438|O1|Outcome|Intravenous 10%|
250140|NCT01218438|O2|Outcome|Subcutaneous 20%|
250141|NCT01218438|O1|Outcome|Intravenous 10%|
250142|NCT01218438|O2|Outcome|Subcutaneous 20%|
250143|NCT01218438|O1|Outcome|Intravenous 10%|
250144|NCT01218438|O2|Outcome|Subcutaneous 20%|
250145|NCT01218438|O1|Outcome|Intravenous 10%|
250146|NCT01218438|O2|Outcome|Subcutaneous 20%|
250147|NCT01218438|O1|Outcome|Intravenous 10%|
250148|NCT01218438|O2|Outcome|Subcutaneous 20%|
250149|NCT01218438|O1|Outcome|Intravenous 10%|
250150|NCT01218438|O2|Outcome|Subcutaneous 20%|
250151|NCT01218438|O1|Outcome|Intravenous 10%|
250152|NCT01218438|O2|Outcome|Subcutaneous 20%|
250153|NCT01218438|O1|Outcome|Intravenous 10%|
250154|NCT01218438|O2|Outcome|Subcutaneous 20%|
250155|NCT01218438|O1|Outcome|Intravenous 10%|
250156|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
250157|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
250158|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
250159|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
250160|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
250161|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
250162|NCT01218438|O1|Outcome|Correction Factor|
250163|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20%, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
250164|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
250165|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250166|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
298132|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
250167|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
250168|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
250169|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250170|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250171|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
250172|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
250173|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250174|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250175|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20%, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
250176|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
250177|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250178|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 WeeksOverall Study Arm|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250179|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
250180|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
250181|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250182|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250183|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
250184|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
250185|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250186|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250243|NCT01218399|P1|Participant Flow|Symbicort|"Combination of budesonide and formoterol
Symbicort will be given as per product insert (2 puffs twice daily of 160/4.5 Budesonide/formoterol)"
250187|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
250188|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
250189|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250190|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250191|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
250192|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
250193|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250194|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250195|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
250196|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
250197|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Week|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250198|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250199|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
250200|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
250201|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250202|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250203|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
250204|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
250205|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250206|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
250244|NCT01218399|O2|Outcome|Budesonide|"control of budesonide alone
Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
250207|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously (IGSC)
250208|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|"Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
Immune globulin administered subcutaneously (IGSC)"
250209|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study.
Immune globulin administered intravenously (IGIV)"
250210|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study.
Immune globulin administered intravenously (IGIV)"
250211|NCT01218438|O1|Outcome|Study Epochs 1-4|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250212|NCT01218438|O1|Outcome|Overall Study Arm|
250213|NCT01218438|O1|Outcome|Overall Study Arm|
250214|NCT01218438|O5|Outcome|SC 20% Individualized 1 Week|
250215|NCT01218438|O4|Outcome|SC 20% Adjusted 1 Week|
250216|NCT01218438|O3|Outcome|SC 20% 145% IV 1 Week|
250217|NCT01218438|O2|Outcome|IV 10% 4 Weeks|
250218|NCT01218438|O1|Outcome|IV 10% 3 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250219|NCT01218438|O1|Outcome|Study Epochs 1-4|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250220|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250221|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
250222|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250223|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
250245|NCT01218399|O1|Outcome|Symbicort|"combination of budesonide and formoterol
Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
250246|NCT01218399|O2|Outcome|Budesonide|"control of budesonide alone
Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
250247|NCT01218399|O1|Outcome|Symbicort|"combination of budesonide and formoterol
Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
298133|NCT00150618|E5|Reported Event|Placebo|once daily
250224|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250225|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
250226|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250227|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
250228|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250229|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
250230|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250231|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
250232|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250233|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
250234|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.
EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
250235|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
250236|NCT01218438|O1|Outcome|Study Participants|
250237|NCT01218438|E2|Reported Event|Study Epochs 2-4: Subcutaneous 20% Treatment|
250238|NCT01218438|E1|Reported Event|Study Epoch 1: Intravenous 10% Treatment|
250239|NCT01218399|B3|Baseline|Total|Total of all reporting groups
250240|NCT01218399|B2|Baseline|Budesonide|"control of budesonide alone
Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
250241|NCT01218399|B1|Baseline|Symbicort|"combination of budesonide and formoterol
Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
250242|NCT01218399|P2|Participant Flow|Budesonide|"Control of budesonide alone
Pulmicort Flexhaler will be given as per product insert (2 puffs twice daily of 160 mcg)"
300231|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
250248|NCT01218399|E2|Reported Event|Budesonide|"control of budesonide alone
Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
250249|NCT01218399|E1|Reported Event|Symbicort|"combination of budesonide and formoterol
Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide"
250250|NCT01218308|B3|Baseline|Total|Total of all reporting groups
250251|NCT01218308|B2|Baseline|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250252|NCT01218308|B1|Baseline|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250253|NCT01218308|P2|Participant Flow|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250254|NCT01218308|P1|Participant Flow|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250255|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250256|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250257|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250258|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250259|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250260|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250261|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250262|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250263|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250264|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250265|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250266|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250267|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250268|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250269|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250321|NCT01218100|O4|Outcome|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
250322|NCT01218100|O3|Outcome|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
250270|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250271|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250272|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250273|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250274|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250275|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250276|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250277|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250278|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250279|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250280|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250281|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250282|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250283|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250284|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250285|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250286|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250287|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250288|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250289|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250323|NCT01218100|O2|Outcome|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
250324|NCT01218100|O1|Outcome|Placebo|Placebo group - starting dose is placebo
300233|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
250290|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250291|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250292|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250293|NCT01218308|E2|Reported Event|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250294|NCT01218308|E1|Reported Event|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
250295|NCT01218243|B3|Baseline|Total|Total of all reporting groups
250296|NCT01218243|B2|Baseline|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250297|NCT01218243|B1|Baseline|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250298|NCT01218243|P2|Participant Flow|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250299|NCT01218243|P1|Participant Flow|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250300|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250301|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250302|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250325|NCT01218100|O4|Outcome|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
250326|NCT01218100|O3|Outcome|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
250327|NCT01218100|O2|Outcome|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
250328|NCT01218100|O1|Outcome|Placebo|Placebo group - starting dose is placebo
250329|NCT01218100|E4|Reported Event|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
250303|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250304|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250305|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250306|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250307|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250308|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250309|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250310|NCT01218243|E2|Reported Event|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250311|NCT01218243|E1|Reported Event|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
250312|NCT01218100|B5|Baseline|Total|Total of all reporting groups
250313|NCT01218100|B4|Baseline|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
250314|NCT01218100|B3|Baseline|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
250315|NCT01218100|B2|Baseline|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
250316|NCT01218100|B1|Baseline|Placebo|Placebo group - starting dose is placebo
250317|NCT01218100|P4|Participant Flow|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
250318|NCT01218100|P3|Participant Flow|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
250319|NCT01218100|P2|Participant Flow|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
250320|NCT01218100|P1|Participant Flow|Placebo|Placebo group - starting dose is placebo
250334|NCT01218087|B2|Baseline|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
250335|NCT01218087|B1|Baseline|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant
250336|NCT01218087|P2|Participant Flow|Moldable Positioner Device|Moldable positioner device was used 24/24 hours as a comparison to the cranial cup and moldable positioner study arm.
250337|NCT01218087|P1|Participant Flow|Cranial Cup Device|The cranial cup device was used 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours.
250338|NCT01218087|O2|Outcome|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
250339|NCT01218087|O1|Outcome|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
250340|NCT01218087|O2|Outcome|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
250341|NCT01218087|O1|Outcome|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
250342|NCT01218087|E2|Reported Event|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
250343|NCT01218087|E1|Reported Event|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
250344|NCT01218009|B3|Baseline|Total|Total of all reporting groups
250345|NCT01218009|B2|Baseline|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250346|NCT01218009|B1|Baseline|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250347|NCT01218009|P2|Participant Flow|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250348|NCT01218009|P1|Participant Flow|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250349|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250350|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250351|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250352|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250353|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250354|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250355|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250356|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250357|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250358|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250359|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250360|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250361|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250362|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250363|NCT01218009|E2|Reported Event|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250364|NCT01218009|E1|Reported Event|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
250365|NCT01217957|B6|Baseline|Total|Total of all reporting groups
250366|NCT01217957|B5|Baseline|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250367|NCT01217957|B4|Baseline|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250368|NCT01217957|B3|Baseline|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250369|NCT01217957|B2|Baseline|Phase 1 :Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250370|NCT01217957|B1|Baseline|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250371|NCT01217957|P5|Participant Flow|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250372|NCT01217957|P4|Participant Flow|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250373|NCT01217957|P3|Participant Flow|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250638|NCT01217112|B4|Baseline|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250374|NCT01217957|P2|Participant Flow|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250375|NCT01217957|P1|Participant Flow|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250376|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
250377|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250378|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
250379|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250380|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
250381|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250382|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
250383|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250384|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
250385|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250386|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
250387|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250639|NCT01217112|B3|Baseline|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250388|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
250389|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250390|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
250391|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250392|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
250393|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250394|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250395|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250396|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250397|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250398|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250399|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250400|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250401|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250431|NCT01217944|B3|Baseline|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250402|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250403|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250404|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250405|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250406|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250407|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250408|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250409|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250410|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250411|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250412|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250413|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250414|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250415|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250432|NCT01217944|B2|Baseline|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250539|NCT01217749|P2|Participant Flow|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
250416|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250417|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250418|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
250419|NCT01217957|O1|Outcome|Phase 2 :Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250420|NCT01217957|O1|Outcome|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250421|NCT01217957|O1|Outcome|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250422|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23. mg/m^2 in Phase 1.
250423|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250424|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250425|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250426|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250427|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250428|NCT01217957|E2|Reported Event|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250429|NCT01217957|E1|Reported Event|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
250430|NCT01217944|B4|Baseline|Total|Total of all reporting groups
300234|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
250433|NCT01217944|B1|Baseline|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250434|NCT01217944|P3|Participant Flow|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250435|NCT01217944|P2|Participant Flow|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250436|NCT01217944|P1|Participant Flow|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250437|NCT01217944|O1|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250438|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250439|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250440|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250441|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250442|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250443|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250444|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250445|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250446|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250447|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250448|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250449|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250450|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250451|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250452|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250453|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250454|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250455|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250456|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250457|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250458|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250459|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250460|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250461|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250462|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250463|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250464|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250465|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250632|NCT01217229|B1|Baseline|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
250466|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250467|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
250468|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250469|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250470|NCT01217944|E4|Reported Event|Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3|After month 3 participants did not receive active ranibizumab
250471|NCT01217944|E3|Reported Event|Visudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3|After month 3 participants received active ranibizumab, active vPDT or a combination of the two if needed.
250472|NCT01217944|E2|Reported Event|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
250473|NCT01217944|E1|Reported Event|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
250474|NCT01217892|B5|Baseline|Total|Total of all reporting groups
250475|NCT01217892|B4|Baseline|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
250476|NCT01217892|B3|Baseline|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250477|NCT01217892|B2|Baseline|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250478|NCT01217892|B1|Baseline|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250479|NCT01217892|P4|Participant Flow|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
250480|NCT01217892|P3|Participant Flow|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250481|NCT01217892|P2|Participant Flow|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250482|NCT01217892|P1|Participant Flow|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250483|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
250484|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250485|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250486|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250487|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
250488|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250489|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250490|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250491|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
250492|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250493|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250494|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250495|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
250496|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250497|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250498|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250499|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
250500|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250501|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250502|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250503|NCT01217892|E4|Reported Event|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
250504|NCT01217892|E3|Reported Event|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250505|NCT01217892|E2|Reported Event|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250506|NCT01217892|E1|Reported Event|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
250507|NCT01217840|B3|Baseline|Total|Total of all reporting groups
300415|NCT00153179|O2|Outcome|Healthy Controls, Acipimox Treatment|
250508|NCT01217840|B2|Baseline|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
250509|NCT01217840|B1|Baseline|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
250510|NCT01217840|P2|Participant Flow|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
250511|NCT01217840|P1|Participant Flow|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
250512|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
250513|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
250514|NCT01217840|E2|Reported Event|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
250515|NCT01217840|E1|Reported Event|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
250516|NCT01217827|B3|Baseline|Total|Total of all reporting groups
250517|NCT01217827|B2|Baseline|Control|This group does not receive an intervention.
250518|NCT01217827|B1|Baseline|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.
Clinical Reminder"
250519|NCT01217827|P2|Participant Flow|Control|This group does not receive an intervention.
250520|NCT01217827|P1|Participant Flow|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.
Clinical Reminder"
250521|NCT01217827|O2|Outcome|Control|This group does not receive an intervention.
250522|NCT01217827|O1|Outcome|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.
Clinical Reminder"
250523|NCT01217827|E2|Reported Event|Control|This group does not receive an intervention.
250524|NCT01217827|E1|Reported Event|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.
Clinical Reminder"
250525|NCT01217801|B3|Baseline|Total|Total of all reporting groups
250526|NCT01217801|B2|Baseline|Ondanestron Orally Disintegrating Tablet|Ondanestron Orally Disintegrating Tablet (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Dissolving Filmstrip (8 mg); AUCs for each period will be calculated.
250527|NCT01217801|B1|Baseline|Ondanestron Orally Dissolving Filmstrip|Ondanestron Orally Dissolving Filmstrip (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Disintegrating tablets (8 mg); AUCs for each period will be calculated.
250528|NCT01217801|P2|Participant Flow|Ondansetron Orally Disintegrating Tablet Then OD Film|Ondansetron Orally Disintegrating Tablet AUC Ondansetron 8 mg then 7 days then Ondansetron Orally Disintegrating Film 8 mg measure AUC
250529|NCT01217801|P1|Participant Flow|Ondansetron Orally Dissolving Filmstrip Then ODT|Ondansetron Orally Dissolving Filmstrip 8 mg then 7 days then Ondansetron Orally Disintegrating Tablet 8 mg measure AUC
250530|NCT01217801|O2|Outcome|Tablet|tablet AUC
250531|NCT01217801|O1|Outcome|Film|AUC film strip
250532|NCT01217801|E2|Reported Event|Ondanestron Orally Disintegrating Tablet|Ondanestron Orally Disintegrating Tablet AUC
250533|NCT01217801|E1|Reported Event|Ondanestron Orally Dissolving Filmstrip|Ondanestron Orally Dissolving Filmstrip AUC
250534|NCT01217749|B4|Baseline|Total|Total of all reporting groups
250535|NCT01217749|B3|Baseline|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
250536|NCT01217749|B2|Baseline|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
250633|NCT01217229|P1|Participant Flow|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
250541|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
250542|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
250543|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
250544|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
250545|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO daily was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
250546|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
250547|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
250548|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
250549|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
250550|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
250551|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
250552|NCT01217749|E3|Reported Event|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
250553|NCT01217749|E2|Reported Event|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
250554|NCT01217749|E1|Reported Event|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
250555|NCT01216631|B4|Baseline|Total|Total of all reporting groups
250556|NCT01216631|B3|Baseline|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)
Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
250557|NCT01216631|B2|Baseline|IA Infliximab|"intra-articular injection of 100mg infliximab
Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
250558|NCT01216631|B1|Baseline|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)
methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
250559|NCT01216631|P3|Participant Flow|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)
Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
250560|NCT01216631|P2|Participant Flow|IA Infliximab|"intra-articular injection of 100mg infliximab
Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
250561|NCT01216631|P1|Participant Flow|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)
methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
250562|NCT01216631|O3|Outcome|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)
Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
250563|NCT01216631|O2|Outcome|IA Infliximab|"intra-articular injection of 100mg infliximab
Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
250564|NCT01216631|O1|Outcome|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)
methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
250565|NCT01216631|E3|Reported Event|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)
Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
250566|NCT01216631|E2|Reported Event|IA Infliximab|"intra-articular injection of 100mg infliximab
Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
250567|NCT01216631|E1|Reported Event|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)
methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
250568|NCT01217606|B3|Baseline|Total|Total of all reporting groups
250569|NCT01217606|B2|Baseline|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
250570|NCT01217606|B1|Baseline|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
250571|NCT01217606|P2|Participant Flow|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks in the Initial Treatment Phase followed by a 9 month Masked Extension.
250572|NCT01217606|P1|Participant Flow|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks in the Initial Treatment Phase followed by a 9 month Masked Extension.
250573|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
250574|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
250575|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
250634|NCT01217229|O1|Outcome|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
250576|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
250577|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
250578|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
250579|NCT01217606|E2|Reported Event|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
250580|NCT01217606|E1|Reported Event|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
250581|NCT01217515|B4|Baseline|Total|Total of all reporting groups
250582|NCT01217515|B3|Baseline|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily"
250583|NCT01217515|B2|Baseline|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily"
250584|NCT01217515|B1|Baseline|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily"
250585|NCT01217515|P3|Participant Flow|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily"
250586|NCT01217515|P2|Participant Flow|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily"
250587|NCT01217515|P1|Participant Flow|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily"
250588|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily"
250589|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily"
250590|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily"
250591|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily"
250592|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily"
250593|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily"
250594|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily"
250595|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily"
250596|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily"
250597|NCT01217515|E3|Reported Event|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.
Placebo : 3 times daily"
250598|NCT01217515|E2|Reported Event|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 4% cream : 3 times daily"
250599|NCT01217515|E1|Reported Event|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.
Diltiazem hydrochloride 2% cream : 3 times daily"
250600|NCT01217476|B3|Baseline|Total|Total of all reporting groups
250601|NCT01217476|B2|Baseline|Placebo|Matching placebo spray
250602|NCT01217476|B1|Baseline|Trafermin|Trafermin 0.01% spray
250603|NCT01217476|P2|Participant Flow|Placebo|Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
250604|NCT01217476|P1|Participant Flow|Trafermin|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
250605|NCT01217476|O2|Outcome|Placebo|Matching placebo spray
250606|NCT01217476|O1|Outcome|Trafermin|Trafermin 0.01% spray
250607|NCT01217476|O2|Outcome|Placebo|Matching placebo spray
250608|NCT01217476|O1|Outcome|Trafermin|Trafermin 0.01% spray
250609|NCT01217476|E2|Reported Event|Placebo|Matching placebo spray
250610|NCT01217476|E1|Reported Event|Trafermin|Trafermin 0.01% spray
250611|NCT01217463|B3|Baseline|Total|Total of all reporting groups
250612|NCT01217463|B2|Baseline|Placebo|Matching placebo spray
250613|NCT01217463|B1|Baseline|Trafermin|Trafermin 0.01% spray
250614|NCT01217463|P2|Participant Flow|Placebo|Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
250640|NCT01217112|B2|Baseline|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250615|NCT01217463|P1|Participant Flow|Trafermin|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
250616|NCT01217463|O2|Outcome|Matching Placebo Spray|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
250617|NCT01217463|O1|Outcome|Trafermin 0.01% Spray|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
250618|NCT01217463|O2|Outcome|Placebo|Matching placebo spray
250619|NCT01217463|O1|Outcome|Trafermin|Trafermin 0.01% spray
250620|NCT01217463|E2|Reported Event|Placebo|Matching placebo spray
250621|NCT01217463|E1|Reported Event|Trafermin|Trafermin 0.01% spray
250622|NCT01217411|B4|Baseline|Total|Total of all reporting groups
250623|NCT01217411|B3|Baseline|Arm II (WBRT or SRS and RO4929097)|"Patients with >= 4 brain lesions receive RO4929097 and undergo WBRT as in phase I and patients with =< 3 brain lesions receive RO4929097 and undergo SRS as in phase I.
Gamma-secretase/Notch signalling pathway inhibitor RO4929097: MTD Dosing cohorts: 5 mg, 10 mg and 20 mg given orally (3 days on/4 days off continuous) 1 day prior to beginning WBRT or 2 days prior to SRS.
For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.
Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality
Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
250624|NCT01217411|B2|Baseline|Arm I (WBRT or SRS)|"Patients with >= 4 brain lesions undergo Whole-Brain Radiotherapy (WBRT) as in phase I and patients with =< 3 brain lesions undergo Stereotactic Radiosurgery (SRS) as in phase I.
Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality
Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
250625|NCT01217411|B1|Baseline|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg
For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT
For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
250626|NCT01217411|P3|Participant Flow|Arm II (WBRT or SRS and RO4929097)|"Patients with >= 4 brain lesions receive RO4929097 and undergo WBRT as in Phase I and patients with =< 3 brain lesions receive RO4929097 and undergo SRS as in Phase I.
Gamma-secretase/Notch signalling pathway inhibitor RO4929097: Maximum tolerated dose (MTD) derived from Phase I given orally (3 days on/4 days off continuous) 1 day prior to beginning WBRT or 2 days prior to SRS.
For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.
Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality
Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
250627|NCT01217411|P2|Participant Flow|Arm I (WBRT or SRS)|"Patients with >= 4 brain lesions undergo WBRT as in Phase I and patients with =< 3 brain lesions undergo SRS as in Phase I.
Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality
Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
250628|NCT01217411|P1|Participant Flow|Phase I MTD Arm|"RO4929097 starting dose oral 5 mg; Dosing cohorts: 5 mg, 10 mg and 20 mg
For patients with 4 or more lesions: Phase I Whole-Brain Radiotherapy (WBRT) + RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT
For patients with 3 or fewer lesions: Phase I Stereotactic Radiosurgery (SRS) + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS
For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.
SRS: Radiosurgery 20 Gray (Gy) for tumors up to 1 cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions. WBRT: Radiotherapy 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for SRS"
250629|NCT01217411|O1|Outcome|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg
For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT
For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
250630|NCT01217411|O1|Outcome|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg
For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT
For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
250631|NCT01217411|E1|Reported Event|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg
For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT
For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
300416|NCT00153179|O1|Outcome|Healthy Controls, Placebo Treatment|
250643|NCT01217112|P4|Participant Flow|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250644|NCT01217112|P3|Participant Flow|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250645|NCT01217112|P2|Participant Flow|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250646|NCT01217112|P1|Participant Flow|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250647|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250648|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250649|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250650|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250651|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250652|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250653|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250654|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250655|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250656|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250657|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250658|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250659|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250660|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250661|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250662|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250663|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250664|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250665|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250666|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250667|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250668|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250669|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250670|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250671|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250672|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250673|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250674|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250675|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250676|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250677|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250678|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250679|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250680|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250681|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250682|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250683|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250684|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250685|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250686|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250687|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250688|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250689|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250690|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250691|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250692|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250693|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250694|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250695|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250696|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250697|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250698|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250699|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250700|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250701|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250702|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250703|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250704|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250705|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250706|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250707|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250708|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250709|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250710|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250711|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250712|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250713|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250714|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250715|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250716|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250717|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250718|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250719|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250720|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250721|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250722|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250723|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250724|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250725|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250726|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250727|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250728|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250729|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250730|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250731|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250732|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250733|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250734|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250735|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250736|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250737|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250738|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250739|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250740|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250741|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250742|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250743|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250744|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250745|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250746|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250747|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250748|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250749|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250750|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250751|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250752|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250753|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250754|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250755|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250756|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250757|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250758|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250759|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250760|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250761|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250762|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250763|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250764|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250765|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250766|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250767|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250768|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250769|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250770|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250771|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250772|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250773|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250774|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250775|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250776|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250778|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250779|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250780|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250781|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250782|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250783|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250784|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250785|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250786|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250787|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250788|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250789|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250790|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250791|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250792|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250793|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250794|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250795|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250796|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250797|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250798|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250799|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250800|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250801|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250802|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250803|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250804|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250805|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250806|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250807|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250808|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250809|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250810|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250811|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250812|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250813|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250814|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250815|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250816|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250817|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250818|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250819|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250820|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250821|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250822|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250823|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250824|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250825|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250826|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250827|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250828|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250829|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250830|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250831|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250832|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250833|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250834|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250835|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250836|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250837|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250838|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250839|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250840|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250841|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250842|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250843|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250844|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250845|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250846|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250847|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250848|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250849|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250850|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250851|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250852|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250853|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250854|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250855|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250856|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250857|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250858|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250859|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250860|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250861|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250862|NCT01217112|O5|Outcome|Placebo|Contains excipients only
250863|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250864|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250865|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250866|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250867|NCT01217112|E5|Reported Event|Placebo|Contains excipients only
250868|NCT01217112|E4|Reported Event|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
250869|NCT01217112|E3|Reported Event|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
250870|NCT01217112|E2|Reported Event|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
250871|NCT01217112|E1|Reported Event|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
250872|NCT01217073|B7|Baseline|Total|Total of all reporting groups
250873|NCT01217073|B6|Baseline|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
250874|NCT01217073|B5|Baseline|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
250875|NCT01217073|B4|Baseline|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
250876|NCT01217073|B3|Baseline|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
250877|NCT01217073|B2|Baseline|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
250878|NCT01217073|B1|Baseline|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
250879|NCT01217073|P8|Participant Flow|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
250880|NCT01217073|P7|Participant Flow|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (extension period)
250881|NCT01217073|P6|Participant Flow|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
250882|NCT01217073|P5|Participant Flow|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
250883|NCT01217073|P4|Participant Flow|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
250884|NCT01217073|P3|Participant Flow|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
250885|NCT01217073|P2|Participant Flow|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
250886|NCT01217073|P1|Participant Flow|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
250887|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
250888|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250889|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250890|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250891|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250892|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250893|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
300417|NCT00153179|E2|Reported Event|Metabolic Syndrome|
250894|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
250895|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
250896|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250897|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250898|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250899|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250900|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250901|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
250902|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
250903|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
250904|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250905|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250906|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250907|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250908|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
250909|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
250910|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
250911|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
250912|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
250913|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
250914|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
250915|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
250916|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
250917|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
250918|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
250919|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
250920|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
250921|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
250922|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
250923|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
250924|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
250925|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
250926|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
250927|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
250928|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
251619|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
250929|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
250930|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
250931|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
250932|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
250933|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
250934|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
250935|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
250936|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
250937|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
250938|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
250939|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
250940|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
250941|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
250942|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
250943|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
250944|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
250945|NCT01217073|E8|Reported Event|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
250946|NCT01217073|E7|Reported Event|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
250947|NCT01217073|E6|Reported Event|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
250948|NCT01217073|E5|Reported Event|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
250949|NCT01217073|E4|Reported Event|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
250950|NCT01217073|E3|Reported Event|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
250951|NCT01217073|E2|Reported Event|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
250952|NCT01217073|E1|Reported Event|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
250953|NCT01216943|B1|Baseline|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
250954|NCT01216943|P1|Participant Flow|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
250955|NCT01216943|O1|Outcome|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
250956|NCT01216943|E1|Reported Event|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
250957|NCT01216761|B1|Baseline|Total Population|
250958|NCT01216761|P3|Participant Flow|PI Then IT Then CHG|"10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI
Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT
2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG"
250959|NCT01216761|P2|Participant Flow|IT Then CHG Then PI|"Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT
2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG
10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI"
250960|NCT01216761|P1|Participant Flow|CHG Then PI Then IT|"2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG
10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI
Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT"
250961|NCT01216761|O3|Outcome|Povidone Iodine (PI)|10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI
250962|NCT01216761|O2|Outcome|Iodine Tincture (IT)|Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT
250963|NCT01216761|O1|Outcome|Chlorhexidine Gluconate (CHG_|2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG
250964|NCT01216761|E3|Reported Event|PI Then IT Then CHG|"10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI
Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT
2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG"
250999|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics
Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
251000|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
250965|NCT01216761|E2|Reported Event|IT Then CHG Then PI|"Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT
2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG
10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI"
250966|NCT01216761|E1|Reported Event|CHG Then PI Then IT|"2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG
10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI
Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT"
250967|NCT01216748|B1|Baseline|Controls|health-lifetime non-smokers were enrolled
250968|NCT01216748|P1|Participant Flow|All Study Participants|healthy lifetime non smokers were challenged with 4 respiratory manouvers: quiet breathing, hypocapnic hyperventilation, hypercapnic hyperventilation, and eucapnic hyperventilation in random order.
250969|NCT01216748|O1|Outcome|Health Controls|Health lifetime non smokers were recruited.
250970|NCT01216748|O1|Outcome|Health Controls|Health lifetime non smokers were recruited.
250971|NCT01216748|E1|Reported Event|Health Controls|Health lifetime non smokers were recruited.
250972|NCT01216735|B3|Baseline|Total|Total of all reporting groups
250973|NCT01216735|B2|Baseline|Non-smokers|this group served as controls for baseline data. No intervention or treatment were assigned to this group.
250974|NCT01216735|B1|Baseline|Smokers|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.
Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
250975|NCT01216735|P2|Participant Flow|Placebo First, Then Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.
Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo"
250976|NCT01216735|P1|Participant Flow|Fluticasone First, Then Placebo|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.
Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo"
250977|NCT01216735|O2|Outcome|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.
Placebo: Placebo MDI"
250978|NCT01216735|O1|Outcome|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.
Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
250979|NCT01216735|O2|Outcome|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.
Placebo: Placebo MDI"
250980|NCT01216735|O1|Outcome|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.
Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
250981|NCT01216735|E2|Reported Event|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.
Fluticasone: 220 ug twice a day for 3 weeks
Placebo: Placebo for 3 weeks"
250982|NCT01216735|E1|Reported Event|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.
Fluticasone: 220 ug twice a day for 3 weeks
Placebo: Placebo for 3 weeks"
250983|NCT01216410|B4|Baseline|Total|Total of all reporting groups
250984|NCT01216410|B3|Baseline|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics
Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
250985|NCT01216410|B2|Baseline|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
250986|NCT01216410|B1|Baseline|Combination Group|"Metoclopramide and Ondansetron prophylaxis
Combination Group : Metoclopramide and ondansetron prophylaxis"
250987|NCT01216410|P3|Participant Flow|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics
Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
250988|NCT01216410|P2|Participant Flow|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
250989|NCT01216410|P1|Participant Flow|Combination Group|"Metoclopramide and Ondansetron prophylaxis
Combination Group : Metoclopramide and ondansetron prophylaxis"
250990|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics
Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
250991|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
250992|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis
Combination Group : Metoclopramide and ondansetron prophylaxis"
250993|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics
Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
250994|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
250995|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis
Combination Group : Metoclopramide and ondansetron prophylaxis"
250996|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics
Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
250997|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
250998|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis
Combination Group : Metoclopramide and ondansetron prophylaxis"
251337|NCT01215786|E2|Reported Event|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
251001|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis
Combination Group : Metoclopramide and ondansetron prophylaxis"
251002|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics
Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
251003|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
251004|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis
Combination Group : Metoclopramide and ondansetron prophylaxis"
251005|NCT01216410|E3|Reported Event|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics
Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
251006|NCT01216410|E2|Reported Event|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
251007|NCT01216410|E1|Reported Event|Combination Group|"Metoclopramide and Ondansetron prophylaxis
Combination Group : Metoclopramide and ondansetron prophylaxis"
251008|NCT01216397|B1|Baseline|All Participants|Treatment with standard batch and side batch
251009|NCT01216397|P2|Participant Flow|Side Batch Then Standard Batch|Linagliptin/metformin FDC tablet from side batch, then Linagliptin/metformin FDC tablet from standard batch
251010|NCT01216397|P1|Participant Flow|Standard Batch Then Side Batch|Linagliptin/metformin FDC tablet from standard batch, then Linagliptin/metformin FDC tablet from side batch
251011|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251012|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251013|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251014|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251015|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251016|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251017|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251018|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251019|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251020|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251021|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251022|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251023|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251024|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251025|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251026|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251027|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251028|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251029|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251030|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251031|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251032|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251033|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251034|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251035|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251036|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251037|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251038|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251039|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251040|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251041|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251042|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251043|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251044|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251045|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251046|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251047|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251048|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251049|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251050|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251051|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251052|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251053|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251054|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251055|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251056|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251057|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251058|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251059|NCT01216397|E2|Reported Event|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251060|NCT01216397|E1|Reported Event|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
251061|NCT01216319|B1|Baseline|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
251062|NCT01216319|P1|Participant Flow|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
251063|NCT01216319|O1|Outcome|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
251064|NCT01216319|O1|Outcome|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
251065|NCT01216319|E1|Reported Event|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
251066|NCT01216241|B3|Baseline|Total|Total of all reporting groups
251067|NCT01216241|B2|Baseline|Saline Placebo|"Saline solution
Saline Placebo : 50 ml normal saline once daily
Daptomycin : 8 mg/kg once daily"
251068|NCT01216241|B1|Baseline|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.
Daptomycin : 8 mg/kg once daily
Daptomycin : 8 MG/KG IV"
251069|NCT01216241|P2|Participant Flow|Saline Placebo|"Saline solution
Saline Placebo : 50 ml normal saline once daily
Daptomycin : 8 mg/kg once daily"
251070|NCT01216241|P1|Participant Flow|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.
Daptomycin : 8 mg/kg once daily
Daptomycin : 8 MG/KG IV"
251071|NCT01216241|O2|Outcome|Saline Placebo|"Saline solution
Saline Placebo : 50 ml normal saline once daily
Daptomycin : 8 mg/kg once daily"
251072|NCT01216241|O1|Outcome|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.
Daptomycin : 8 mg/kg once daily
Daptomycin : 8 MG/KG IV"
251073|NCT01216241|E2|Reported Event|Saline Placebo|"Saline solution
Saline Placebo : 50 ml normal saline once daily
Daptomycin : 8 mg/kg once daily"
251074|NCT01216241|E1|Reported Event|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.
Daptomycin : 8 mg/kg once daily
Daptomycin : 8 MG/KG IV"
251075|NCT01216163|B4|Baseline|Total|Total of all reporting groups
251076|NCT01216163|B3|Baseline|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251077|NCT01216163|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251078|NCT01216163|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251079|NCT01216163|P3|Participant Flow|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251080|NCT01216163|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251081|NCT01216163|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251082|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251083|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251084|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251085|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251086|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251087|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251088|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251089|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251090|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251091|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251092|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251093|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251094|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251095|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251096|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251097|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251098|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251099|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251100|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251101|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251102|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251103|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251104|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251105|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251106|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251107|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251620|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251108|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251109|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251110|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251111|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251112|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251113|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251114|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251115|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251116|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251117|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251118|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251119|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251120|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251121|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251122|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251123|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251124|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251125|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251126|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251127|NCT01216163|E3|Reported Event|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
251128|NCT01216163|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
251129|NCT01216163|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
251130|NCT01216072|B3|Baseline|Total|Total of all reporting groups
251131|NCT01216072|B2|Baseline|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251132|NCT01216072|B1|Baseline|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251133|NCT01216072|P2|Participant Flow|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251134|NCT01216072|P1|Participant Flow|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251135|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251136|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251137|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251138|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251139|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251140|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251141|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251142|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251143|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251144|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251145|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251146|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251147|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251148|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251149|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251150|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251151|NCT01216072|O3|Outcome|Extension Fingolimod Period|An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251152|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
251153|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251154|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251155|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251156|NCT01216072|E3|Reported Event|Fingolimod Extension Phase|An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
251157|NCT01216072|E2|Reported Event|Standard MS DMT|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
251158|NCT01216072|E1|Reported Event|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
251159|NCT01215981|B3|Baseline|Total|Total of all reporting groups
251160|NCT01215981|B2|Baseline|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
251161|NCT01215981|B1|Baseline|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
251162|NCT01215981|P2|Participant Flow|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
251163|NCT01215981|P1|Participant Flow|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
251164|NCT01215981|O2|Outcome|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant.
251165|NCT01215981|O1|Outcome|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 1 dose (day of enrollment) of seasonal influenza vaccine after transplant.
251166|NCT01215981|O2|Outcome|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant.
251167|NCT01215981|O1|Outcome|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 1 dose (day of enrollment) of seasonal influenza vaccine after transplant.
251168|NCT01215981|E2|Reported Event|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
251169|NCT01215981|E1|Reported Event|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
251170|NCT01215968|B3|Baseline|Total|Total of all reporting groups
251171|NCT01215968|B2|Baseline|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
251172|NCT01215968|B1|Baseline|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
251173|NCT01215968|P2|Participant Flow|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
251174|NCT01215968|P1|Participant Flow|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
251175|NCT01215968|O3|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
251176|NCT01215968|O2|Outcome|Placebo (Week 1)|Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
251177|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
251178|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
251179|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
251180|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
251181|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
251182|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
251183|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
300418|NCT00153179|E1|Reported Event|Healthy Controls|
251184|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
251185|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
251186|NCT01215968|E3|Reported Event|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
251187|NCT01215968|E2|Reported Event|Placebo (Week 1)|Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
251188|NCT01215968|E1|Reported Event|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
251189|NCT01215955|B5|Baseline|Total|Total of all reporting groups
251190|NCT01215955|B4|Baseline|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251191|NCT01215955|B3|Baseline|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251192|NCT01215955|B2|Baseline|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based dose was on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251193|NCT01215955|B1|Baseline|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251194|NCT01215955|P4|Participant Flow|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251195|NCT01215955|P3|Participant Flow|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251196|NCT01215955|P2|Participant Flow|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251197|NCT01215955|P1|Participant Flow|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251198|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251199|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251200|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251201|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251202|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251338|NCT01215786|E1|Reported Event|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
251203|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251204|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251205|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251206|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251207|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251208|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251209|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251210|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251211|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251212|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251213|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251214|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251215|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251216|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251217|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251339|NCT01215734|B3|Baseline|Total|Total of all reporting groups
251218|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251219|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251220|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251221|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251222|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251223|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251224|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251225|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251226|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251227|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251228|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251229|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251230|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251231|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251232|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251410|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251233|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251234|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251235|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251236|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251237|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251238|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251239|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251240|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251241|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251242|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251243|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251244|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251245|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251246|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251247|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251411|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251248|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251249|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251250|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251251|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251252|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251253|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251254|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251255|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251256|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251257|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251258|NCT01215955|E4|Reported Event|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251259|NCT01215955|E3|Reported Event|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
251260|NCT01215955|E2|Reported Event|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251261|NCT01215955|E1|Reported Event|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).
Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.
Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
251262|NCT01215929|B3|Baseline|Total|Total of all reporting groups
251263|NCT01215929|B2|Baseline|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
251264|NCT01215929|B1|Baseline|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
251265|NCT01215929|P2|Participant Flow|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
251266|NCT01215929|P1|Participant Flow|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
251267|NCT01215929|O2|Outcome|Placebo|Placebo: Thirty-five treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
251268|NCT01215929|O1|Outcome|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
251269|NCT01215929|E2|Reported Event|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
251270|NCT01215929|E1|Reported Event|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
251271|NCT01215851|B7|Baseline|Total|Total of all reporting groups
251272|NCT01215851|B6|Baseline|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
251273|NCT01215851|B5|Baseline|Rifafour e-275 mg|Rifafour e-275 administered once daily with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
251274|NCT01215851|B4|Baseline|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets and pyrazinamide administered once daily in 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
251275|NCT01215851|B3|Baseline|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
251276|NCT01215851|B2|Baseline|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251277|NCT01215851|B1|Baseline|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251278|NCT01215851|P6|Participant Flow|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
251279|NCT01215851|P5|Participant Flow|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
251280|NCT01215851|P4|Participant Flow|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
251281|NCT01215851|P3|Participant Flow|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
251412|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251621|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251282|NCT01215851|P2|Participant Flow|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251283|NCT01215851|P1|Participant Flow|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251284|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
251285|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
251286|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
251287|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
251288|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251289|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251290|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
251291|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
251292|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
251293|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
251294|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251295|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251296|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
251297|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
251298|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
251299|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
251300|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|MC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251301|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
300419|NCT00159419|B3|Baseline|Total|Total of all reporting groups
251302|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
251303|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
251304|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
251305|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
251306|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251307|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251308|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
251309|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
251310|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
251311|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
251312|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251313|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
251314|NCT01215851|E6|Reported Event|TMC207 and PA-824|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 200 mg
251315|NCT01215851|E5|Reported Event|Rifafour e-275 mg|Rifafour e-275 275 mg
251316|NCT01215851|E4|Reported Event|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 200 mg and pyrazinamide (dosed by weight) and moxifloxacin 400 mg
251317|NCT01215851|E3|Reported Event|PA-824 and Pyrazinamide|PA-824 200mg and pyrazinamide (dosed by weight)and moxifloxacin placebo
251318|NCT01215851|E2|Reported Event|TMC207 and Pyrazinamide|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide (dosed by weight)
251319|NCT01215851|E1|Reported Event|TMC207|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide placebo
251320|NCT01215786|B4|Baseline|Total|Total of all reporting groups
251321|NCT01215786|B3|Baseline|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
251322|NCT01215786|B2|Baseline|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
251323|NCT01215786|B1|Baseline|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
251324|NCT01215786|P3|Participant Flow|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
251325|NCT01215786|P2|Participant Flow|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
251326|NCT01215786|P1|Participant Flow|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
251327|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
251328|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
251329|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
251330|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
251331|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
251332|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
251333|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
251334|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
251335|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
251336|NCT01215786|E3|Reported Event|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
251340|NCT01215734|B2|Baseline|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.
Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
251341|NCT01215734|B1|Baseline|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
251342|NCT01215734|P2|Participant Flow|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.
Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
251343|NCT01215734|P1|Participant Flow|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
251344|NCT01215734|O2|Outcome|Standard Dose Trivalent Inactivated Flu Vaccine|Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
251345|NCT01215734|O1|Outcome|High-Dose Trivalent Inactivated Influenza Vaccine|High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms [µg] per antigen) on visit 1
251346|NCT01215734|O2|Outcome|Standard Dose Trivalent Inactivated Flu Vaccine|Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
251347|NCT01215734|O1|Outcome|High-Dose Trivalent Inactivated Influenza Vaccine|High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms [µg] per antigen) on visit 1
251348|NCT01215734|E2|Reported Event|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine.
Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
251349|NCT01215734|E1|Reported Event|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
251350|NCT01215721|B1|Baseline|Vesicare|Vesicare™ (Solifenacin) : 5 mg daily
251351|NCT01215721|P1|Participant Flow|Vesicare|Vesicare™ (Solifenacin) : 5 mg daily
251352|NCT01215721|O1|Outcome|Vesicare, 5mg Treatment Group|Vesicare™ (Solifenacin) : 5 mg daily
251353|NCT01215721|E1|Reported Event|Vesicare, 5mg Treatment Group|Vesicare™ (Solifenacin) : 5 mg daily
251354|NCT01215695|B3|Baseline|Total|Total of all reporting groups
251355|NCT01215695|B2|Baseline|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
251356|NCT01215695|B1|Baseline|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
251357|NCT01215695|P2|Participant Flow|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
251358|NCT01215695|P1|Participant Flow|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
251359|NCT01215695|O2|Outcome|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
251360|NCT01215695|O1|Outcome|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
251361|NCT01215695|O2|Outcome|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
251362|NCT01215695|O1|Outcome|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
251363|NCT01215695|O2|Outcome|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
251364|NCT01215695|O1|Outcome|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
251413|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251365|NCT01215695|O2|Outcome|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
251366|NCT01215695|O1|Outcome|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
251367|NCT01215695|O2|Outcome|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
251368|NCT01215695|O1|Outcome|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
251369|NCT01215695|E2|Reported Event|Intervention|"Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor."
251370|NCT01215695|E1|Reported Event|Control|"Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope"
251371|NCT01215643|B6|Baseline|Total|Total of all reporting groups
251372|NCT01215643|B5|Baseline|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251373|NCT01215643|B4|Baseline|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251374|NCT01215643|B3|Baseline|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251375|NCT01215643|B2|Baseline|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251376|NCT01215643|B1|Baseline|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251377|NCT01215643|P5|Participant Flow|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251378|NCT01215643|P4|Participant Flow|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with peginterferon alfa-2a (PEG) during Weeks 2 to 24.
251379|NCT01215643|P3|Participant Flow|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251380|NCT01215643|P2|Participant Flow|ALV 600 mg+RBV|ALV 600 mg BID with ribavirin (RBV) for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251381|NCT01215643|P1|Participant Flow|ALV 1000 mg|Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
251382|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251383|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251384|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251385|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251386|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251387|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251388|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251389|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251390|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251391|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251392|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251393|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251394|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251395|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251396|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251397|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251398|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251399|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251400|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251401|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251402|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251403|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251404|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251405|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251406|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251407|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251408|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251409|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251414|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251415|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251416|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251417|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251418|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251419|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251420|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251421|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251422|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251423|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251424|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251425|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251426|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251427|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251428|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251429|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251430|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251431|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251432|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251433|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251434|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251435|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251436|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251437|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251438|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251439|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251440|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251441|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251442|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251443|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251444|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251445|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251446|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251447|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251448|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251449|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251450|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251451|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251452|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251453|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251454|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251455|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251456|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251457|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251458|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251459|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251460|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251461|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251462|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251463|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251464|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251465|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251466|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251467|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
251468|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251469|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251470|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251471|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251472|NCT01215643|E10|Reported Event|PEG+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving PEG and RBV during Weeks 1 to 24.
251473|NCT01215643|E9|Reported Event|ALV 600 mg+PEG: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251474|NCT01215643|E8|Reported Event|ALV 800 mg+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251475|NCT01215643|E7|Reported Event|ALV 600 mg+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251476|NCT01215643|E6|Reported Event|ALV 1000 mg: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251477|NCT01215643|E5|Reported Event|PEG+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving PEG and RBV during Weeks 1 to 24.
251478|NCT01215643|E4|Reported Event|ALV 600 mg+PEG: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
251479|NCT01215643|E3|Reported Event|ALV 800 mg+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
251480|NCT01215643|E2|Reported Event|ALV 600 mg+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
251481|NCT01215643|E1|Reported Event|ALV 1000 mg: On-treatment AEs|Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
251482|NCT01215513|B1|Baseline|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals
251483|NCT01215513|P1|Participant Flow|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
251484|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals
251485|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
251486|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
251487|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
251488|NCT01215513|E1|Reported Event|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
251489|NCT01215435|B3|Baseline|Total|Total of all reporting groups
251490|NCT01215435|B2|Baseline|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251491|NCT01215435|B1|Baseline|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251492|NCT01215435|P2|Participant Flow|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251493|NCT01215435|P1|Participant Flow|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251494|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251495|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251496|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251497|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251498|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251499|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251500|NCT01215435|E2|Reported Event|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251501|NCT01215435|E1|Reported Event|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
251502|NCT01215422|B5|Baseline|Total|Total of all reporting groups
251503|NCT01215422|B4|Baseline|GS Intubaton Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
251504|NCT01215422|B3|Baseline|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
251505|NCT01215422|B2|Baseline|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
251506|NCT01215422|B1|Baseline|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
251507|NCT01215422|P4|Participant Flow|GS Intubation Participants|Children intubated with the GlideScope system (GS) VLS
251508|NCT01215422|P3|Participant Flow|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface DCI (KS) VLS
251509|NCT01215422|P2|Participant Flow|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice.
251510|NCT01215422|P1|Participant Flow|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
251511|NCT01215422|O2|Outcome|KS Intubations|Anesthesiologists who intubated minimum 18 children with the KS VLS
251512|NCT01215422|O1|Outcome|GS Intubations|Anesthesiologists who intubated minimum 18 children with the GS VLS.
251513|NCT01215422|O2|Outcome|Randomized to KS First|
251514|NCT01215422|O1|Outcome|Randomized to GS First|
251515|NCT01215422|O3|Outcome|Baseline Intubation Participants|Children intubated with the standard laryngoscope of the anesthesiologist's choice
251516|NCT01215422|O2|Outcome|KS Intubation Participants|Children successfully intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
251517|NCT01215422|O1|Outcome|GS Intubation Participants|Children successfully intubated with the GlideScope system (GS) video laryngoscope (VLS)
251518|NCT01215422|O4|Outcome|KS Intubation Times for Those Who Used GS First|
251519|NCT01215422|O3|Outcome|GS Intubation Times for Those Who Used KS First|
251520|NCT01215422|O2|Outcome|KS Intubation Times for Those Who Used KS First|
251521|NCT01215422|O1|Outcome|GS Intubation Times for Those Who Used GS First|
251522|NCT01215422|O3|Outcome|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope of the anesthesiologist's choice
251523|NCT01215422|O2|Outcome|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
251524|NCT01215422|O1|Outcome|GS Intubation Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
251525|NCT01215422|O2|Outcome|KS Intubations|Anesthesiologists who performed minimum 18 intubations with the KS VLS
251526|NCT01215422|O1|Outcome|GS Intubations|Anesthesiologists who performed minimum 18 intubations with the GS VLS.
251527|NCT01215422|E4|Reported Event|GS Intubaton Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
251528|NCT01215422|E3|Reported Event|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
251529|NCT01215422|E2|Reported Event|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
251530|NCT01215422|E1|Reported Event|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
251531|NCT01215357|B1|Baseline|Ecopipam 50 or 100 mg, as Needed|Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
251560|NCT01215292|O2|Outcome|Acyline + Tgel + Ketoconazole 400mg|Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole
251532|NCT01215357|P1|Participant Flow|Ecopipam (50 or 100 mg, as Needed)|Patients were instructed to take a 50 mg tablet each time they had an urge to gamble. If that was ineffective, they were instructed to take a second 50 mg tablet. If that was ineffective, they were not allowed to increase the dose further.
251533|NCT01215357|O1|Outcome|Ecopipam 50 mg or 100 mg as Needed|Patients were instructed to take one 50 mg tablet of ecopipam when they had an urge to gamble. If this was effective, they should not take any more drug. If it was not effective, they were permitted to take a second 50 mg tablet of ecopipam. If this was effective, they should not take any more drug. If this was not effective, they were not permitted to take any additional ecopipam.
251534|NCT01215357|E1|Reported Event|Ecopipam 50 or 100 mg, as Needed|Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
251535|NCT01215344|B3|Baseline|Total|Total of all reporting groups
251536|NCT01215344|B2|Baseline|VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)|"VELCADE, liposomal doxorubicin, dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle
Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
251537|NCT01215344|B1|Baseline|VRD (VELCADE, Lenalidomide, Dexamethasone)|"VELCADE, Lenalidomide, Dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
Lenalidomide: 25 mg by mouth on days 1-4 of each cycle
Dexamethasone: 20 mg the day before and the day after receiving VELCADE
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
251538|NCT01215344|P2|Participant Flow|VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)|"VELCADE, liposomal doxorubicin, dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle
Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
251539|NCT01215344|P1|Participant Flow|VRD (VELCADE, Lenalidomide, Dexamethasone)|"VELCADE, Lenalidomide, Dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
Lenalidomide: 25 mg by mouth on days 1-4 of each cycle
Dexamethasone: 20 mg the day before and the day after receiving VELCADE
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
251540|NCT01215344|O2|Outcome|MRD Status Positive at Day 100 (Post-AHCT)|Patients with MRD status stay positive at both EOI and day 100.
251541|NCT01215344|O1|Outcome|MRD Negative at Day 100|Patients with MRD status negative at day 100 (post-AHCT). They have MRD negative or positve at EOI.
251542|NCT01215344|O2|Outcome|VELCADE, Liposomal Doxorubicin, Dexamethasone (VDD)|"VELCADE, liposomal doxorubicin, dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle
Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
251543|NCT01215344|O1|Outcome|VELCADE, Lenalidomide, Dexamethasone (VRD)|"VELCADE, Lenalidomide, Dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
Lenalidomide: 25 mg by mouth on days 1-4 of each cycle
Dexamethasone: 20 mg the day before and the day after receiving VELCADE
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
251544|NCT01215344|E2|Reported Event|VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)|"VELCADE, liposomal doxorubicin, dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle
Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4"
251545|NCT01215344|E1|Reported Event|VRD (VELCADE, Lenalidomide, Dexamethasone)|"VELCADE, Lenalidomide, Dexamethasone
VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
Lenalidomide: 25 mg by mouth on days 1-4 of each cycle
Dexamethasone: 20 mg the day before and the day after receiving VELCADE
DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice
Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care."
251546|NCT01215292|B6|Baseline|Total|Total of all reporting groups
251547|NCT01215292|B5|Baseline|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
251548|NCT01215292|B4|Baseline|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
251549|NCT01215292|B3|Baseline|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
251550|NCT01215292|B2|Baseline|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
251551|NCT01215292|B1|Baseline|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
251552|NCT01215292|P5|Participant Flow|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
251553|NCT01215292|P4|Participant Flow|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
251554|NCT01215292|P3|Participant Flow|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
251555|NCT01215292|P2|Participant Flow|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
251556|NCT01215292|P1|Participant Flow|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
251557|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole 1mg|
251558|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride 2.5mg|
251559|NCT01215292|O3|Outcome|Acyline + Tgel + Ketoconazole 800mg|Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole
251562|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + Anastrazole 1mg x 7 days
251563|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + dutasteride 2.5mg x 7 days
251564|NCT01215292|O3|Outcome|Acyline & TGel & Ketoconazole 800 mg|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + 800mg ketoconazole x 7 days
251565|NCT01215292|O2|Outcome|Acyline & TGel & Ketoconazole 400 mg|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + ketoconazole 400mg x 7 days
251566|NCT01215292|O1|Outcome|Acyline + Testosterone Gel (Tgel)+ Placebo|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + placebo
251567|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole 1mg|
251568|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride 2.5mg|
251569|NCT01215292|O3|Outcome|Acyline + Tgel + Ketoconazole 800mg|300mcg Acyline, 1% testosterone gel 5g daily + 800 mg ketoconazole
251570|NCT01215292|O2|Outcome|Acyline + Tgel + Ketoconazole 400mg|300mcg Acyline, 1% testosterone gel 5g daily + 400 mg ketoconazole
251571|NCT01215292|O1|Outcome|Acyline + Testosterone Gel + Placebo|300mcg Acyline, 1% testosterone gel 5g daily + placebo
251572|NCT01215292|E5|Reported Event|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
251573|NCT01215292|E4|Reported Event|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
251574|NCT01215292|E3|Reported Event|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
251575|NCT01215292|E2|Reported Event|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
251576|NCT01215292|E1|Reported Event|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
251577|NCT01215279|B3|Baseline|Total|Total of all reporting groups
251578|NCT01215279|B2|Baseline|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251579|NCT01215279|B1|Baseline|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251580|NCT01215279|P2|Participant Flow|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251581|NCT01215279|P1|Participant Flow|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251582|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251583|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251584|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251585|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251586|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251587|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251588|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251589|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251590|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251591|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251592|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251593|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251594|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251595|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251596|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251597|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251598|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251599|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251600|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251601|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251602|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251603|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251604|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251605|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251606|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251607|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251608|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251609|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251610|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251611|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251612|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251613|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251614|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251615|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251616|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251617|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251618|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251622|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251623|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251624|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251625|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251626|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251627|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251628|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251629|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251630|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251631|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251632|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251633|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251634|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251635|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251636|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251637|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251638|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251639|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251640|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251641|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251642|NCT01215279|E2|Reported Event|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
251643|NCT01215279|E1|Reported Event|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
251644|NCT01215227|B7|Baseline|Total|Total of all reporting groups
251645|NCT01215227|B6|Baseline|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251646|NCT01215227|B5|Baseline|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251647|NCT01215227|B4|Baseline|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251648|NCT01215227|B3|Baseline|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251649|NCT01215227|B2|Baseline|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251650|NCT01215227|B1|Baseline|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251651|NCT01215227|P6|Participant Flow|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251652|NCT01215227|P5|Participant Flow|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251653|NCT01215227|P4|Participant Flow|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251654|NCT01215227|P3|Participant Flow|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251655|NCT01215227|P2|Participant Flow|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251656|NCT01215227|P1|Participant Flow|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251740|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
251657|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251658|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251659|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251660|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251661|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251662|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251663|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251664|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251665|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251666|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251667|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251668|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251669|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251670|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251671|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251672|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251673|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251674|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251675|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251741|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
251742|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
251676|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251677|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251678|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251679|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251680|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251681|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251682|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251683|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251684|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251685|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251686|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251687|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251688|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251689|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251690|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251691|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251692|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251693|NCT01215227|E6|Reported Event|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251694|NCT01215227|E5|Reported Event|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
251743|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
251744|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
251695|NCT01215227|E4|Reported Event|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251696|NCT01215227|E3|Reported Event|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251697|NCT01215227|E2|Reported Event|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251698|NCT01215227|E1|Reported Event|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
251699|NCT01215123|B1|Baseline|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
251700|NCT01215123|P1|Participant Flow|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
251701|NCT01215123|O1|Outcome|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
251702|NCT01215123|O1|Outcome|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
251703|NCT01215123|E1|Reported Event|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
251704|NCT01215110|B6|Baseline|Total|Total of all reporting groups
251705|NCT01215110|B5|Baseline|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
251706|NCT01215110|B4|Baseline|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
251707|NCT01215110|B3|Baseline|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
251708|NCT01215110|B2|Baseline|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
251709|NCT01215110|B1|Baseline|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
251710|NCT01215110|P5|Participant Flow|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
251711|NCT01215110|P4|Participant Flow|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
251712|NCT01215110|P3|Participant Flow|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
251713|NCT01215110|P2|Participant Flow|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
251714|NCT01215110|P1|Participant Flow|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
251715|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
251716|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
251717|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
251718|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
251719|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
251720|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
251721|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
251722|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
251723|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
251724|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
251725|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
251726|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
251727|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
251728|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
251729|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
251730|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
251731|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
251732|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
251733|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
251734|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
251735|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
251736|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
251737|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
251738|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
251739|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
251745|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
251746|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
251747|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
251748|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
251749|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
251750|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
251751|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
251752|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
251753|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
251754|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
251755|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
251756|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
251757|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
251758|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
251759|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
251760|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
251761|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
251762|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
251763|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
251764|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
251765|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
251766|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
251767|NCT01215110|E5|Reported Event|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
251768|NCT01215110|E4|Reported Event|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
251769|NCT01215110|E3|Reported Event|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
251770|NCT01215110|E2|Reported Event|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
251771|NCT01215110|E1|Reported Event|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
251772|NCT01215097|B3|Baseline|Total|Total of all reporting groups
251773|NCT01215097|B2|Baseline|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251774|NCT01215097|B1|Baseline|Placebo|Placebo
251775|NCT01215097|P2|Participant Flow|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251776|NCT01215097|P1|Participant Flow|Placebo|Placebo
251777|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251778|NCT01215097|O1|Outcome|Placebo|Placebo
251779|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251780|NCT01215097|O1|Outcome|Placebo|Placebo
251781|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251782|NCT01215097|O1|Outcome|Placebo|Placebo
251783|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251784|NCT01215097|O1|Outcome|Placebo|Placebo
251785|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251786|NCT01215097|O1|Outcome|Placebo|Placebo
251787|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251788|NCT01215097|O1|Outcome|Placebo|Placebo
251789|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251790|NCT01215097|O1|Outcome|Placebo|Placebo
251791|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251792|NCT01215097|O1|Outcome|Placebo|Placebo
251793|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251794|NCT01215097|O1|Outcome|Placebo|Placebo
251795|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251796|NCT01215097|O1|Outcome|Placebo|Placebo
251797|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251798|NCT01215097|O1|Outcome|Placebo|Placebo
251799|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251800|NCT01215097|O1|Outcome|Placebo|Placebo
251801|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251802|NCT01215097|O1|Outcome|Placebo|Placebo
251803|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251804|NCT01215097|O1|Outcome|Placebo|Placebo
251805|NCT01215097|E2|Reported Event|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
251806|NCT01215097|E1|Reported Event|Placebo|Placebo
251807|NCT01215032|B1|Baseline|Metformin|"This is the only arm of this phase 2 open label study
Metformin: Taken orally twice daily each 28-day cycle"
251808|NCT01215032|P1|Participant Flow|Metformin|"This is the only arm of this phase 2 open label study
Metformin: Taken orally twice daily each 28-day cycle"
251809|NCT01215032|O2|Outcome|Abnormal Baseline Hemoglobin A1c|Hemoglobin A1c greater than or equal to 6.0 before metformin dosing began.
251810|NCT01215032|O1|Outcome|Normal Baseline Hemoglobin A1c|Hemoglobin A1c less than 6.0 before metformin dosing began.
251811|NCT01215032|O1|Outcome|Metformin|"This is the only arm of this phase 2 open label study
Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles"
251812|NCT01215032|O1|Outcome|Metformin|"This is the only arm of this phase 2 open label study
Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles"
300420|NCT00159419|B2|Baseline|Alendronate Treatment|
251813|NCT01215032|O1|Outcome|Metformin|"This is the only arm of this phase 2 open label study
Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles"
251814|NCT01215032|E1|Reported Event|Metformin|"This is the only arm of this phase 2 open label study
Metformin: Taken orally twice daily each 28-day cycle"
251815|NCT01214980|B3|Baseline|Total|Total of all reporting groups
251816|NCT01214980|B2|Baseline|Control Arm|"Standard of care treatment
Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
251817|NCT01214980|B1|Baseline|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
251818|NCT01214980|P2|Participant Flow|Control Arm|"Standard of care treatment
Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
251819|NCT01214980|P1|Participant Flow|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
251820|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment
Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
251821|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
251822|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment
Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
251823|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
251824|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment
Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
251825|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
251826|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment
Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
251827|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
251828|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment
Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
251829|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
251830|NCT01214980|E2|Reported Event|Control Arm|"Standard of care treatment
Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
251831|NCT01214980|E1|Reported Event|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment
MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
251832|NCT01214915|B1|Baseline|Anagrelide Hydrochloride|
251833|NCT01214915|P1|Participant Flow|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
251834|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
251835|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
251836|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
251837|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
251838|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
251839|NCT01214915|E1|Reported Event|Anagrelide Hydrochloride|
251840|NCT01214850|B4|Baseline|Total|Total of all reporting groups
251841|NCT01214850|B3|Baseline|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251842|NCT01214850|B2|Baseline|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251843|NCT01214850|B1|Baseline|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251844|NCT01214850|P3|Participant Flow|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251845|NCT01214850|P2|Participant Flow|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251846|NCT01214850|P1|Participant Flow|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251847|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251848|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251849|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251850|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
251851|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251852|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
251853|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251854|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251855|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251856|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251857|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251858|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251859|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251860|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251861|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251862|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251863|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251864|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251865|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251866|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251867|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251868|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251869|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251870|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251871|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251872|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251873|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251874|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251875|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251876|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251877|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251878|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251879|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251880|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251881|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251882|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251883|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
252136|NCT01214395|E1|Reported Event|Tea Tree Oil Application|tea tree oil medication group
251884|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251885|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251886|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251887|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251888|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251889|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251890|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251891|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251892|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251893|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251894|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251895|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251896|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251897|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251898|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251899|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251900|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251901|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251902|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251903|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251904|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251905|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251906|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251907|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
251908|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251909|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251910|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251911|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251912|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251913|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251914|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251915|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251916|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251917|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251918|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251919|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251920|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251921|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251922|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251923|NCT01214850|E3|Reported Event|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
251924|NCT01214850|E2|Reported Event|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
251925|NCT01214850|E1|Reported Event|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
251926|NCT01214837|B4|Baseline|Total|Total of all reporting groups
251927|NCT01214837|B3|Baseline|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
251928|NCT01214837|B2|Baseline|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251929|NCT01214837|B1|Baseline|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251930|NCT01214837|P3|Participant Flow|Routine Vaccines|Subjects received routine vaccines only, including pneumococcal 13-valent conjugate vaccine (PCV-13), at 2, 4, 6 and 12 months of age.
251931|NCT01214837|P2|Participant Flow|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251932|NCT01214837|P1|Participant Flow|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251933|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
251934|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251935|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251936|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
251937|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251938|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251939|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
251940|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251941|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251942|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
251943|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251944|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251945|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
251946|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251947|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251948|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251949|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251950|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251951|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251952|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251953|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251954|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251955|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251956|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
251957|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251958|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251959|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
251960|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251961|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251962|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251963|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251964|NCT01214837|O1|Outcome|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251965|NCT01214837|E3|Reported Event|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
251966|NCT01214837|E2|Reported Event|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
251967|NCT01214837|E1|Reported Event|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
251968|NCT01214824|B1|Baseline|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
251969|NCT01214824|P1|Participant Flow|Intervention Group|Participants using the FreeStyle Navigator System Intermittently. At the start and end of the study subjects wore the FreeStyle Navigator masked (without seeing continuous glucose results) for 5 days (1 sensor wear). During the study subjects used the FreeStyle Navigator fully functional (unmasked) for 2 periods. The first unmasked phase was for 2 weeks (3 sensor wears) following the baseline masked wear. The second unmasked phase was a 5 day wear at 3 months. After each unmasked phase the HCP reviewed results with the subject and changes to insulin regimen were recommended as required. For the remainder of the study a standard blood glucose meter was used for diabetes management.
251970|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
251971|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
251972|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System intermittently
251973|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
251974|NCT01214824|E1|Reported Event|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
251975|NCT01214811|B1|Baseline|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag
Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
251976|NCT01214811|P1|Participant Flow|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag
Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
251977|NCT01214811|O1|Outcome|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag
Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
251978|NCT01214811|E1|Reported Event|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag
Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
251979|NCT01213823|B3|Baseline|Total|Total of all reporting groups
251980|NCT01213823|B2|Baseline|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
251981|NCT01213823|B1|Baseline|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
251982|NCT01213823|P2|Participant Flow|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
251983|NCT01213823|P1|Participant Flow|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
251984|NCT01213823|O2|Outcome|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
251985|NCT01213823|O1|Outcome|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
251986|NCT01213823|E2|Reported Event|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
251987|NCT01213823|E1|Reported Event|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
252137|NCT01214330|B1|Baseline|Solopap|females, age >18, without severe hand arthritis
251988|NCT01213706|B1|Baseline|Whole Body Periodic Acceleration (WBPA)|"Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.
Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min."
251989|NCT01213706|P1|Participant Flow|SHAM WBPA Then WBPA|
251990|NCT01213706|O2|Outcome|Sham WBPA|Subjects will be resting on the platform without any WBPA.
251991|NCT01213706|O1|Outcome|WBPA|Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.
251992|NCT01213706|E2|Reported Event|Sham WBPA|"The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.
Sham WBPA: The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge."
251993|NCT01213706|E1|Reported Event|Whole Body Periodic Acceleration (WBPA)|"Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.
Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min."
251994|NCT01213589|B4|Baseline|Total|Total of all reporting groups
251995|NCT01213589|B3|Baseline|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
251996|NCT01213589|B2|Baseline|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
251997|NCT01213589|B1|Baseline|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
251998|NCT01213589|P3|Participant Flow|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
251999|NCT01213589|P2|Participant Flow|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
252000|NCT01213589|P1|Participant Flow|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
252001|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
252002|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
252003|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
252004|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
252005|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
252006|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
252007|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
252008|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
252009|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
252010|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
252011|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
252012|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
252013|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
252049|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm
Truvada: Tenofovir 200mg/emtricitabine 300mg once a day
Raltegravir: Raltegravir 400mg twice a day"
300421|NCT00159419|B1|Baseline|Pamidronate Treatment|
252014|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
252015|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
252016|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
252017|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
252018|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
252019|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
252020|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
252021|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
252022|NCT01213589|E3|Reported Event|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
252023|NCT01213589|E2|Reported Event|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
252024|NCT01213589|E1|Reported Event|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
252025|NCT01213576|B5|Baseline|Total|Total of all reporting groups
252026|NCT01213576|B4|Baseline|Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual|Albendazole 800mg and ivermectin 400mcg/kg given twice a year
252027|NCT01213576|B3|Baseline|Albendazole 400mg and Ivermectin 200mcg/kg Biannual|Albendazole 400mg and ivermectin 200mcg/kg given twice a year
252028|NCT01213576|B2|Baseline|Albendazole 800mg and Ivermectin 400mcg/kg Annual|Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg orally given once a year
252029|NCT01213576|B1|Baseline|Albendazole 400mg and Ivermectin 200mcg/kg Annual|Albendazole 400mg and ivermectin 200mcg/kg: 400 mg orally given once a year
252030|NCT01213576|P4|Participant Flow|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year
Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
252031|NCT01213576|P3|Participant Flow|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year
albendazole 400mg and ivermectin 200mcg/kg given twice a year"
252032|NCT01213576|P2|Participant Flow|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment
Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
252033|NCT01213576|P1|Participant Flow|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment
Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
252034|NCT01213576|O4|Outcome|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year
Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
252035|NCT01213576|O3|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year
albendazole 400mg and ivermectin 200mcg/kg given twice a year"
252036|NCT01213576|O2|Outcome|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment
Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
252037|NCT01213576|O1|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment
Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
252038|NCT01213576|O4|Outcome|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year
Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
252039|NCT01213576|O3|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year
albendazole 400mg and ivermectin 200mcg/kg given twice a year"
252040|NCT01213576|O2|Outcome|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment
Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
252041|NCT01213576|O1|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment
Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
252042|NCT01213576|E4|Reported Event|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year
Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
252043|NCT01213576|E3|Reported Event|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year
albendazole 400mg and ivermectin 200mcg/kg given twice a year"
252044|NCT01213576|E2|Reported Event|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment
Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
252045|NCT01213576|E1|Reported Event|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment
Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
252046|NCT01214759|B1|Baseline|Truvada and Raltegravir|"Single arm
Truvada: Tenofovir 200mg/emtricitabine 300mg once a day
Raltegravir: Raltegravir 400mg twice a day"
252047|NCT01214759|P1|Participant Flow|Truvada and Raltegravir|"Single arm
Truvada: Tenofovir 200mg/emtricitabine 300mg once a day
Raltegravir: Raltegravir 400mg twice a day"
252048|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm
Truvada: Tenofovir 200mg/emtricitabine 300mg once a day
Raltegravir: Raltegravir 400mg twice a day"
252138|NCT01214330|P1|Participant Flow|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears
Self Pap Smear"
252050|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm
Truvada: Tenofovir 200mg/emtricitabine 300mg once a day
Raltegravir: Raltegravir 400mg twice a day"
252051|NCT01214759|E1|Reported Event|Truvada and Raltegravir|"Single arm
Truvada: Tenofovir 200mg/emtricitabine 300mg once a day
Raltegravir: Raltegravir 400mg twice a day"
252052|NCT01214720|B3|Baseline|Total|Total of all reporting groups
252053|NCT01214720|B2|Baseline|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252054|NCT01214720|B1|Baseline|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252055|NCT01214720|P2|Participant Flow|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252056|NCT01214720|P1|Participant Flow|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg per square meter (mg/m^2) IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, orally (PO), once daily (QD) for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252057|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252058|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252059|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252060|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252061|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252062|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252079|NCT01214616|P2|Participant Flow|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252139|NCT01214330|O1|Outcome|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears
Self Pap Smear"
252063|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252064|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252065|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252066|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252067|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252068|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252069|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252070|NCT01214720|E2|Reported Event|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252071|NCT01214720|E1|Reported Event|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
252072|NCT01214616|B5|Baseline|Total|Total of all reporting groups
252073|NCT01214616|B4|Baseline|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
252074|NCT01214616|B3|Baseline|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
252075|NCT01214616|B2|Baseline|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252076|NCT01214616|B1|Baseline|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252077|NCT01214616|P4|Participant Flow|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
252078|NCT01214616|P3|Participant Flow|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
252080|NCT01214616|P1|Participant Flow|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252081|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
252082|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
252083|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252084|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252085|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
252086|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
252087|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252088|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252089|NCT01214616|O4|Outcome|Vinorelbine 25 mg/m^2 Without Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
252090|NCT01214616|O3|Outcome|Vinorelbine 25 mg/m^2 With Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
252091|NCT01214616|O2|Outcome|Vinorelbine 20 mg/m^2 Without Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
252092|NCT01214616|O1|Outcome|Vinorelbine 20 mg/m^2 With Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
252093|NCT01214616|O4|Outcome|Vinorelbine 25 mg/m^2 Without Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
252094|NCT01214616|O3|Outcome|Vinorelbine 25 mg/m^2 With Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
252095|NCT01214616|O2|Outcome|Vinorelbine 20 mg/m^2 Without Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
252096|NCT01214616|O1|Outcome|Vinorelbine 20 mg/m^2 With Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
252097|NCT01214616|O4|Outcome|Afatinib 40 mg Without Vinorelbine|"Afatinib 40 mg oral administration once a day without vinorelbine intravenous injection weekly.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
252098|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine|"Afatinib 40 mg oral administration once a day with vinorelbine intravenous injection weekly.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
252099|NCT01214616|O2|Outcome|Afatinib 20 mg Without Vinorelbine|"Afatinib 20 mg oral administration once a day without vinorelbine intravenous injection weekly.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
300422|NCT00159419|P2|Participant Flow|Alendronate Treatment|
252100|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine|"Afatinib 20 mg oral administration once a day with vinorelbine intravenous injection weekly.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
252101|NCT01214616|O4|Outcome|Afatinib 40 mg Without Vinorelbine|"Afatinib 40 mg oral administration once a day without vinorelbine intravenous injection weekly.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
252102|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine|"Afatinib 40 mg oral administration once a day with vinorelbine intravenous injection weekly.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
252103|NCT01214616|O2|Outcome|Afatinib 20 mg Without Vinorelbine|"Afatinib 20 mg oral administration once a day without vinorelbine intravenous injection weekly.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
252104|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine|"Afatinib 20 mg oral administration once a day with vinorelbine intravenous injection weekly.
All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.
On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
252105|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
252106|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
252107|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252108|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252109|NCT01214616|E4|Reported Event|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
252110|NCT01214616|E3|Reported Event|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
252111|NCT01214616|E2|Reported Event|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252112|NCT01214616|E1|Reported Event|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
252113|NCT01214434|B3|Baseline|Total|Total of all reporting groups
252114|NCT01214434|B2|Baseline|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
252115|NCT01214434|B1|Baseline|Bland Emollient|Bland emollient : Eucerin cream twice daily
252116|NCT01214434|P2|Participant Flow|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
252117|NCT01214434|P1|Participant Flow|Bland Emollient|Bland emollient : Eucerin cream twice daily
252118|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
252119|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
252120|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
252121|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
252122|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
252123|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
252124|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
252125|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
252126|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
252127|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
252128|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
252129|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
252130|NCT01214434|E2|Reported Event|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
252131|NCT01214434|E1|Reported Event|Bland Emollient|Bland emollient : Eucerin cream twice daily
252132|NCT01214395|B1|Baseline|Tea Tree Oil Application|tea tree oil medication group
252133|NCT01214395|P1|Participant Flow|Tea Tree Oil Application|tea tree oil medication group
252134|NCT01214395|O1|Outcome|Did Not Have Staph. Aureus Infection|No exit site infection or peritonitis with Staph. aureus
252135|NCT01214395|O1|Outcome|Tea Tree Oil|tea tree oil application
252140|NCT01214330|E1|Reported Event|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears
Self Pap Smear"
252141|NCT01214252|B1|Baseline|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
252142|NCT01214252|P1|Participant Flow|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
252143|NCT01214252|O1|Outcome|Permacol Patients|"Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
Permacol Surgical Implant: Permacol Surgical Implant"
252144|NCT01214252|O1|Outcome|Permacol Patients|"Total (confirmed or unconfrimed) hernia or hernia recurrence at the repair site by year (# and percentage).
Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms questionnaire but not confirmed by clinical assessment by a surgeon or medical chart review"
252145|NCT01214252|O1|Outcome|Permacol Patients|"Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
Permacol Surgical Implant: Permacol Surgical Implant"
252146|NCT01214252|E1|Reported Event|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
252147|NCT01214239|B3|Baseline|Total|Total of all reporting groups
252148|NCT01214239|B2|Baseline|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252149|NCT01214239|B1|Baseline|Placebo|Placebo
252150|NCT01214239|P2|Participant Flow|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252151|NCT01214239|P1|Participant Flow|Placebo|Placebo
252152|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252153|NCT01214239|O1|Outcome|Placebo|Placebo
252154|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252155|NCT01214239|O1|Outcome|Placebo|Placebo
252156|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252157|NCT01214239|O1|Outcome|Placebo|Placebo
252158|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252159|NCT01214239|O1|Outcome|Placebo|Placebo
252160|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252161|NCT01214239|O1|Outcome|Placebo|Placebo
252162|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252163|NCT01214239|O1|Outcome|Placebo|Placebo
252164|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252165|NCT01214239|O1|Outcome|Placebo|Placebo
252166|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252167|NCT01214239|O1|Outcome|Placebo|Placebo
252168|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252169|NCT01214239|O1|Outcome|Placebo|Placebo
252170|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252171|NCT01214239|O1|Outcome|Placebo|Placebo
252172|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252173|NCT01214239|O1|Outcome|Placebo|Placebo
252174|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252175|NCT01214239|O1|Outcome|Placebo|Placebo
252176|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252177|NCT01214239|O1|Outcome|Placebo|Placebo
252178|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252179|NCT01214239|O1|Outcome|Placebo|Placebo
252180|NCT01214239|E2|Reported Event|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
252181|NCT01214239|E1|Reported Event|Placebo|Placebo
252182|NCT01214187|B3|Baseline|Total|Total of all reporting groups
252183|NCT01214187|B2|Baseline|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
252184|NCT01214187|B1|Baseline|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.
inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
252185|NCT01214187|P2|Participant Flow|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
252186|NCT01214187|P1|Participant Flow|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.
inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
252187|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
252188|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.
inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
252189|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
252190|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.
inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
252191|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
252192|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.
inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
252193|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
252194|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.
inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
252195|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
252196|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.
inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
252197|NCT01214187|E2|Reported Event|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
252198|NCT01214187|E1|Reported Event|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.
inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
252199|NCT01214174|B4|Baseline|Total|Total of all reporting groups
252200|NCT01214174|B3|Baseline|Dose 3|IBI-10090 1046ug
252201|NCT01214174|B2|Baseline|Dose 2|IBI-10090 776ug
252202|NCT01214174|B1|Baseline|Dose 1|IBI-10090 513ug
252203|NCT01214174|P3|Participant Flow|Dose 3|IBI-10090 1046ug
252204|NCT01214174|P2|Participant Flow|Dose 2|IBI-10090 776ug
252205|NCT01214174|P1|Participant Flow|Dose 1|IBI-10090 513ug
252206|NCT01214174|O3|Outcome|Dose 3|IBI-10090 1046ug
252207|NCT01214174|O2|Outcome|Dose 2|IBI-10090 776ug
252208|NCT01214174|O1|Outcome|Dose 1|IBI-10090 513ug
252209|NCT01214174|E3|Reported Event|Dose 3|IBI-10090 1046ug
252210|NCT01214174|E2|Reported Event|Dose 2|IBI-10090 776ug
252211|NCT01214174|E1|Reported Event|Dose 1|IBI-10090 513ug
252212|NCT01214161|B3|Baseline|Total|Total of all reporting groups
252213|NCT01214161|B2|Baseline|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
252214|NCT01214161|B1|Baseline|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
252215|NCT01214161|P2|Participant Flow|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
252216|NCT01214161|P1|Participant Flow|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
252217|NCT01214161|O2|Outcome|Providers|The healthcare provider placing the IUD on that particular participant.
252218|NCT01214161|O1|Outcome|Participants|The cohort of all 200 women having their IUD inserted.
252219|NCT01214161|O2|Outcome|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
252247|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252248|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252249|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252250|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252220|NCT01214161|O1|Outcome|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
252221|NCT01214161|O2|Outcome|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
252222|NCT01214161|O1|Outcome|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
252223|NCT01214161|E2|Reported Event|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
252224|NCT01214161|E1|Reported Event|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.
2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
252225|NCT01214109|B1|Baseline|All Subjects|24 subjects were equally randomised to one of two groups / sequences, and in general terms, ABCD or BADC. Hence, 12 subjects were in group ABCD and 12 in BADC. All 24 subjects received all treatments, A, B, C, D. The numbers presented are by overall treatment.
252226|NCT01214109|P4|Participant Flow|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252227|NCT01214109|P3|Participant Flow|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252228|NCT01214109|P2|Participant Flow|0.125 mg t.i.d. Immediate Release (IR)|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252229|NCT01214109|P1|Participant Flow|0.375 mg q.d.Extended Release (ER)|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252230|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252231|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252232|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252233|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252234|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252235|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252236|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252237|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252238|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252239|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252240|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252241|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252242|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252243|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252244|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252245|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252246|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
300423|NCT00159419|P1|Participant Flow|Pamidronate Treatment|
252251|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252252|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252253|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252254|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252255|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252256|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252257|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252258|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252259|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252260|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252261|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252262|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252263|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252264|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252265|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252266|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252267|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252268|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252269|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252270|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252271|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252272|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252273|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252274|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252275|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252276|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252277|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252278|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252279|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252280|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252281|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252282|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252283|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252284|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252285|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252286|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252287|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252288|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252289|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252290|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252291|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252292|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252293|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252294|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252295|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252296|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252297|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252298|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252299|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252300|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252301|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252302|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252303|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
300424|NCT00159419|O2|Outcome|Alendronate|
252304|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252305|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252306|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252307|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252308|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252309|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252310|NCT01214109|E7|Reported Event|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252311|NCT01214109|E6|Reported Event|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
252312|NCT01214109|E5|Reported Event|0.375 mg q.d.ER Down-titration|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252313|NCT01214109|E4|Reported Event|0.75 mg q.d. ER Down-titration|0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252314|NCT01214109|E3|Reported Event|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252315|NCT01214109|E2|Reported Event|0.75 mg q.d. ER Up-titration|0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252316|NCT01214109|E1|Reported Event|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
252317|NCT01214083|B4|Baseline|Total|Total of all reporting groups
252318|NCT01214083|B3|Baseline|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252319|NCT01214083|B2|Baseline|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252320|NCT01214083|B1|Baseline|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252321|NCT01214083|P3|Participant Flow|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252322|NCT01214083|P2|Participant Flow|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252323|NCT01214083|P1|Participant Flow|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252324|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252325|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252326|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252327|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252328|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252329|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252330|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252331|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252332|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252333|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252334|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252335|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252336|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252337|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252338|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252339|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252340|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252341|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252342|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252343|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252344|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252345|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252346|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252347|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252348|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252349|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252350|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252351|NCT01214083|E3|Reported Event|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252352|NCT01214083|E2|Reported Event|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
252353|NCT01214083|E1|Reported Event|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
252354|NCT01213966|B5|Baseline|Total|Total of all reporting groups
252355|NCT01213966|B4|Baseline|Cohort 4 - OZ439 1200mg|1200 mg OZ439 po single dose
252356|NCT01213966|B3|Baseline|Cohort 3 - OZ439 200mg|200mg OZ439 p.o. single dose
252357|NCT01213966|B2|Baseline|Cohort 2 - OZ439 400mg|400 mg OZ439 p.o. single dose
252358|NCT01213966|B1|Baseline|Cohort 1 - OZ439 800mg|800 mg OZ439 po single dose
252359|NCT01213966|P4|Participant Flow|1200 mg OZ439 po Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.received single dose
252360|NCT01213966|P3|Participant Flow|200mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
252361|NCT01213966|P2|Participant Flow|400 mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
252362|NCT01213966|P1|Participant Flow|800 mg OZ439 po Single Dose|Cohort 1 received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients was made following a study cohort review
252363|NCT01213966|O4|Outcome|1200 mg OZ439 po Single Dose|"Ultimately, after review of the data from Cohort 1 (800 mg), from Cohort 2 (400 mg), and Cohort 3 (200 mg), patients in Cohort 4 received a single dose of 1200 mg OZ439.
It was decided not to proceed with a fifth cohort and no further patients were enrolled."
252364|NCT01213966|O3|Outcome|200mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg) and data from Cohort 2 (400 mg), patients in Cohort 3 received a single dose of 200 mg OZ439.
252365|NCT01213966|O2|Outcome|400 mg OZ439 p.o. Single Dose|After review of the data from Cohort 1 (800 mg), patients in Cohort 2 received a single dose of 400 mg OZ439.
252366|NCT01213966|O1|Outcome|800 mg OZ439 po Single Dose|The first cohort received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients with either P. falciparum or P. vivax malaria, was made following a study cohort review of the safety data, drug exposure levels, and the PRR over 24 hours after the investigational product administration (PRR24) obtained from the previous cohort.
252367|NCT01213966|E4|Reported Event|Cohort 4 - OZ439 1200mg|1200 mg OZ439 po single dose
252368|NCT01213966|E3|Reported Event|Cohort 3 - OZ439 200mg|200mg OZ439 p.o. single dose
252369|NCT01213966|E2|Reported Event|Cohort 2 - OZ439 400mg|400 mg OZ439 p.o. single dose
252370|NCT01213966|E1|Reported Event|Cohort 1 - OZ439 800mg|800 mg OZ439 po single dose
252371|NCT01213836|B3|Baseline|Total|Total of all reporting groups
252372|NCT01213836|B2|Baseline|First Seroquel IR Then Seroquel XR|Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
252373|NCT01213836|B1|Baseline|First Seroquel XR Then Seroquel IR|Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days
252374|NCT01213836|P2|Participant Flow|First Seroquel IR Then Seroquel XR|Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
252375|NCT01213836|P1|Participant Flow|First Seroquel XR Then Seroquel IR|Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days
252376|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
252377|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
252378|NCT01213836|O2|Outcome|Seroquel IR|Patients treated with at least one dose of Seroquel IR
252379|NCT01213836|O1|Outcome|Seroquel XR|Patients treated with at least one dose of Seroquel XR
252380|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
252381|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
252382|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
252383|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
252384|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
252385|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
252386|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
252387|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
252388|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
252389|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
252390|NCT01213836|E2|Reported Event|Seroquel IR|Patients treated with at least one dose of Seroquel IR
252391|NCT01213836|E1|Reported Event|Seroquel XR|Patients treated with at least one dose of Seroquel XR
252392|NCT01213329|B3|Baseline|Total|Total of all reporting groups
252393|NCT01213329|B2|Baseline|Donor Comparison|
252394|NCT01213329|B1|Baseline|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
252395|NCT01213329|P2|Participant Flow|Donor Comparison|
252396|NCT01213329|P1|Participant Flow|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
252397|NCT01213329|O2|Outcome|Donor Comparison|
252398|NCT01213329|O1|Outcome|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
252399|NCT01213329|E2|Reported Event|Donor Comparison|
252400|NCT01213329|E1|Reported Event|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
252401|NCT01213316|B1|Baseline|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252402|NCT01213316|P1|Participant Flow|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252403|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252404|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252405|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252406|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252407|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252408|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252409|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
252410|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
252411|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
252412|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252413|NCT01213316|O1|Outcome|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252414|NCT01213316|E3|Reported Event|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252415|NCT01213316|E2|Reported Event|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252416|NCT01213316|E1|Reported Event|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
252417|NCT01213264|B4|Baseline|Total|Total of all reporting groups
252418|NCT01213264|B3|Baseline|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
252419|NCT01213264|B2|Baseline|Sugammadex|Participants administered sugammadex for NMB reversal
252420|NCT01213264|B1|Baseline|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
252421|NCT01213264|P3|Participant Flow|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
252422|NCT01213264|P2|Participant Flow|Sugammadex|Participants administered sugammadex for NMB reversal
252423|NCT01213264|P1|Participant Flow|Spontaneous Reversal|Participants whose reversal from neuromuscular blockade (NMB) was spontaneous (no reversal agent used)
252424|NCT01213264|O1|Outcome|Total Study Population|Total population of study participants who received an NMBA or NMB-reversal agent
300425|NCT00159419|O1|Outcome|Pamidronate Treatment|
252425|NCT01213264|O2|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
252426|NCT01213264|O1|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
252427|NCT01213264|O2|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
252428|NCT01213264|O1|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
252429|NCT01213264|O1|Outcome|Total Study Population|Total population of study participants who received an NMBA or NMB-reversal agent
252430|NCT01213264|O3|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
252431|NCT01213264|O2|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
252432|NCT01213264|O1|Outcome|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
252433|NCT01213264|O3|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
252434|NCT01213264|O2|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
252435|NCT01213264|O1|Outcome|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
252436|NCT01213264|E3|Reported Event|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
252437|NCT01213264|E2|Reported Event|Sugammadex|Participants administered sugammadex for NMB reversal
252438|NCT01213264|E1|Reported Event|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
252439|NCT01213251|B4|Baseline|Total|Total of all reporting groups
252440|NCT01213251|B3|Baseline|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
252441|NCT01213251|B2|Baseline|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
252442|NCT01213251|B1|Baseline|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
252443|NCT01213251|P3|Participant Flow|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
252444|NCT01213251|P2|Participant Flow|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
252445|NCT01213251|P1|Participant Flow|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
252446|NCT01213251|O1|Outcome|All Subjects|All subjects randomized in the study (either control, single pacing or dual pacing). For the patients randomized to single or dual site, only patients with successful implant are included.
252447|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
252448|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
252449|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
252450|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
252451|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
252452|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
252453|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
252454|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
252455|NCT01213251|O3|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
252456|NCT01213251|O2|Outcome|Dual Site Pacing|Subjects randomized to the group that were successfully be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
252457|NCT01213251|O1|Outcome|Single Site Pacing|Subjects randomized to the group that were successfully implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
252458|NCT01213251|O2|Outcome|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
252459|NCT01213251|O1|Outcome|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
252460|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
252461|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
252462|NCT01213251|E3|Reported Event|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
252463|NCT01213251|E2|Reported Event|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
252464|NCT01213251|E1|Reported Event|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
252465|NCT01213199|B1|Baseline|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%
Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
252466|NCT01213199|P1|Participant Flow|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%
Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
252467|NCT01213199|O1|Outcome|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%
Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
252468|NCT01213199|E1|Reported Event|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%
Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
252469|NCT01213173|B3|Baseline|Total|Total of all reporting groups
252470|NCT01213173|B2|Baseline|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252471|NCT01213173|B1|Baseline|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252472|NCT01213173|P2|Participant Flow|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252473|NCT01213173|P1|Participant Flow|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252474|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252475|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252476|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252477|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252478|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252479|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252480|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252481|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252482|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252483|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252484|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252485|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252486|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252487|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252488|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252489|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252490|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252491|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252539|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
252492|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252493|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252494|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252495|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252496|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252497|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252498|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252499|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252500|NCT01213173|E2|Reported Event|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
252501|NCT01213173|E1|Reported Event|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
252502|NCT01213043|B3|Baseline|Total|Total of all reporting groups
252503|NCT01213043|B2|Baseline|120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 120 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 60 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
252504|NCT01213043|B1|Baseline|60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 60 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 120 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
252505|NCT01213043|P2|Participant Flow|120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 120 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 60 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
252506|NCT01213043|P1|Participant Flow|60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 60 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 120 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
252507|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
252508|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
252509|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
252510|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
252511|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
252512|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
252513|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
252514|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
252515|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
252516|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
252517|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
252518|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
252519|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
252520|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
252521|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
252522|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
252523|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
252524|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
252525|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
252526|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
252527|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
252528|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
252529|NCT01213043|E2|Reported Event|120 mg/kg Prolastin-C|
252530|NCT01213043|E1|Reported Event|60 mg/kg Prolastin-C|
252531|NCT01212991|B3|Baseline|Total|Total of all reporting groups
252532|NCT01212991|B2|Baseline|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
252533|NCT01212991|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
252534|NCT01212991|P2|Participant Flow|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
252535|NCT01212991|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
252536|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
252537|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
252538|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
253642|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
252540|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
252541|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
252542|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
252543|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
252544|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
252545|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
252546|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
252547|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
252548|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
252549|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
252550|NCT01212991|E2|Reported Event|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
252551|NCT01212991|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
252552|NCT01212874|B3|Baseline|Total|Total of all reporting groups
252553|NCT01212874|B2|Baseline|Esmolol|"esmolol infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass
esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension."
252554|NCT01212874|B1|Baseline|Nitroglycerin|"nitroglycerin infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass
nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery."
252555|NCT01212874|P2|Participant Flow|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
252556|NCT01212874|P1|Participant Flow|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
252557|NCT01212874|O2|Outcome|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
252558|NCT01212874|O1|Outcome|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
252559|NCT01212874|O2|Outcome|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
252560|NCT01212874|O1|Outcome|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
252561|NCT01212874|E2|Reported Event|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
252562|NCT01212874|E1|Reported Event|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
252563|NCT01212770|B4|Baseline|Total|Total of all reporting groups
252564|NCT01212770|B3|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252565|NCT01212770|B2|Baseline|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252566|NCT01212770|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252567|NCT01212770|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
252568|NCT01212770|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
252569|NCT01212770|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years.
252570|NCT01212770|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
252571|NCT01212770|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
252572|NCT01212770|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
252573|NCT01212770|P1|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
252574|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252575|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252576|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252577|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252578|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252579|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252580|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252581|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252582|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252583|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252584|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252585|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252586|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252587|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252588|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252589|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252590|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252591|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252592|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252593|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252594|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252595|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252596|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252597|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252598|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252599|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252600|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252601|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252602|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252603|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252604|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252605|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252606|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252607|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252608|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252609|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252610|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252611|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252612|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252613|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252614|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252615|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252616|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252617|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252618|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252619|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252620|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252621|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252622|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252623|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252624|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252625|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252626|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252627|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252628|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252629|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252630|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252631|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252632|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252633|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252634|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252635|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252636|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252637|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252638|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252639|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252640|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252641|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252642|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252643|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252644|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252645|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252646|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252647|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252648|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252649|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252650|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252651|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252652|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252653|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252654|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252655|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252656|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252657|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252658|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252659|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252660|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252661|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252662|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252663|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252664|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252665|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252666|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252667|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252668|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252669|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252670|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252671|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252672|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252673|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252674|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252675|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252676|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252677|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252678|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252679|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252680|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252681|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252682|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252683|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252684|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252685|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252686|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252687|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252688|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252689|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252690|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252691|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252692|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252693|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252694|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252695|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252696|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252697|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252698|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252699|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252700|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252701|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252702|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252703|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252704|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252705|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
300426|NCT00159419|E2|Reported Event|Alendronate Treatment|
252706|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252707|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252708|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252709|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252710|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252711|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252712|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252713|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252714|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252715|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252716|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252717|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252718|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252719|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252720|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252721|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252722|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252723|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252724|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252725|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252726|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252727|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252728|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252729|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252730|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252731|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252732|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252733|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252734|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252735|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252736|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252737|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252738|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252739|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252740|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252741|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252742|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252743|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252744|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252745|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252746|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252747|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252748|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252749|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252750|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252751|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252752|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252753|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252754|NCT01212770|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
253643|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
252755|NCT01212770|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
252756|NCT01212770|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
252757|NCT01212770|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
252758|NCT01212770|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
252759|NCT01212757|B4|Baseline|Total|Total of all reporting groups
252760|NCT01212757|B3|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252761|NCT01212757|B2|Baseline|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252762|NCT01212757|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252763|NCT01212757|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
252764|NCT01212757|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
252765|NCT01212757|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years.
252766|NCT01212757|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
252767|NCT01212757|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
252768|NCT01212757|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
252769|NCT01212757|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
252770|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252771|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252772|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252773|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252774|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252775|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252776|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252777|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252778|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252779|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252780|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252781|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252782|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252783|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252784|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252785|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252786|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252787|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252788|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252789|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252790|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252791|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252792|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252835|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252793|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252794|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252795|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252796|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252797|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252798|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252799|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252800|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252801|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252802|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252803|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252804|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252805|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252806|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252807|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252808|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252809|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252810|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252811|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252812|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252813|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252814|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252815|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252816|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252817|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252818|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252819|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252820|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252821|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252822|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252823|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252824|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252825|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252826|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252827|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252828|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252829|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252830|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252831|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252832|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252833|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252834|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
253057|NCT01212094|O1|Outcome|Placebo|Group administered placebo
252836|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
252837|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
252838|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252839|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252840|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252841|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252842|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252843|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252844|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252845|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252846|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252847|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252848|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252849|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252850|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252851|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252852|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252853|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252854|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252855|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252856|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252857|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252858|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252859|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252860|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252861|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252862|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252863|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252864|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252865|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252866|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252867|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252868|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252869|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252870|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252871|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252872|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252873|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252874|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252875|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252876|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252877|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252878|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252879|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252880|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252881|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252882|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252883|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252884|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252885|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252886|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252887|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252888|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252889|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252890|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252891|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252892|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252893|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252894|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252895|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252896|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252897|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252898|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252899|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252900|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252901|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252902|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252903|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252904|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252905|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252906|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252907|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252908|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252909|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252910|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252911|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252912|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252913|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252914|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252915|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252916|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252917|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252918|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252919|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252920|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252921|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252922|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
253058|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
252923|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252924|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252925|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252926|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252927|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252928|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252929|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252930|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252931|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252932|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252933|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
252934|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252935|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252936|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252937|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
252938|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
252939|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
252940|NCT01212757|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
252941|NCT01212757|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
252942|NCT01212757|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
252943|NCT01212757|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
252944|NCT01212757|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
252945|NCT01212627|B1|Baseline|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
Ridaforolimus"
252946|NCT01212627|P1|Participant Flow|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
Ridaforolimus"
252947|NCT01212627|O1|Outcome|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
Ridaforolimus"
252948|NCT01212627|E1|Reported Event|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
Ridaforolimus"
252949|NCT01212484|B1|Baseline|All Study Subjects|
252950|NCT01212484|P2|Participant Flow|Carbidopa (First), Placebo (Second)|Subjects will be given Carbidopa for a 4 week period followed by placebo for a 4 week period.
252951|NCT01212484|P1|Participant Flow|Placebo (First), Carbidopa (Second)|Subjects will be given placebo first (4 weeks), followed by carbidopa (4 weeks).
252952|NCT01212484|O2|Outcome|Placebo|
252953|NCT01212484|O1|Outcome|Carbidopa|
252954|NCT01212484|O2|Outcome|Placebo|
252955|NCT01212484|O1|Outcome|Carbidopa|
252956|NCT01212484|O2|Outcome|Placebo|
252957|NCT01212484|O1|Outcome|Carbidopa|
252958|NCT01212484|E2|Reported Event|Placebo|"Placebo
Placebo : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design."
252959|NCT01212484|E1|Reported Event|Carbidopa|"carbidopa
Carbidopa : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design."
252960|NCT01212445|B4|Baseline|Total|Total of all reporting groups
252961|NCT01212445|B3|Baseline|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252962|NCT01212445|B2|Baseline|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252963|NCT01212445|B1|Baseline|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
252964|NCT01212445|P3|Participant Flow|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252965|NCT01212445|P2|Participant Flow|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252966|NCT01212445|P1|Participant Flow|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252967|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252968|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252969|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
252970|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252971|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252972|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
252973|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252974|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252975|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
252976|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252977|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252978|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252979|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252980|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252981|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252982|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252983|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252984|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
252985|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252986|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252987|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
252988|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
253059|NCT01212094|O1|Outcome|Placebo|Group administered placebo
253060|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
252989|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252990|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252991|NCT01212445|E3|Reported Event|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252992|NCT01212445|E2|Reported Event|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252993|NCT01212445|E1|Reported Event|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
252994|NCT01212302|B1|Baseline|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
252995|NCT01212302|P1|Participant Flow|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
252996|NCT01212302|O1|Outcome|Clopidogrel Low Response|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
252997|NCT01212302|E1|Reported Event|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
252998|NCT01212185|B3|Baseline|Total|Total of all reporting groups
252999|NCT01212185|B2|Baseline|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray
intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
253000|NCT01212185|B1|Baseline|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.
intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
253001|NCT01212185|P2|Participant Flow|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray
intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
253002|NCT01212185|P1|Participant Flow|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.
intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 3 days"
253003|NCT01212185|O2|Outcome|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray
intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
253004|NCT01212185|O1|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.
intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
253005|NCT01212185|O2|Outcome|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray
intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
253006|NCT01212185|O1|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.
intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
253007|NCT01212185|E2|Reported Event|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray
intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
253008|NCT01212185|E1|Reported Event|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.
intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
253009|NCT01212172|B1|Baseline|Side-by Side Comparsion of Soprano/SHR to Light Sheer|"Alma Soprano/SHR 810 nm Diode Laser
Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time.
LightSheer Duet 810 nm diode laser
LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
253010|NCT01212172|P2|Participant Flow|LightSheer Duet 810 nm Diode Laser|"Soprano and LightSheer Duet 810 nm diode laser
LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
253011|NCT01212172|P1|Participant Flow|Soprano Duet 810 nm Diode Laser|"Soprano Duet 810 nm diode laser
Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
253012|NCT01212172|O2|Outcome|Soprano/SHR|"Alma Soprano/SHR 810 nm Diode Laser
Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
253013|NCT01212172|O1|Outcome|LightSheer|"LightSheer Duet 810 nm diode laser
LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
253014|NCT01212172|O2|Outcome|LightSheer|"LightSheer Duet 810 nm diode laser
LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
253061|NCT01212094|O1|Outcome|Placebo|Group administered placebo
253062|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
253015|NCT01212172|O1|Outcome|Soprano/SHR|"Alma Soprano/SHR 810 nm Diode Laser
Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
253016|NCT01212172|E2|Reported Event|Light Sheer 810 nm Diode Laser|"Light Sheer 810 nm Diode Laser
Left Axilla or Lower Leg
LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
253017|NCT01212172|E1|Reported Event|Soprano/SHR 810 nm Diode Laser|"Alma Soprano/SHR VS Light Sheer Duet 810 nm Diode Lasers
Right Axilla or Lower Leg
Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
253018|NCT01212159|B3|Baseline|Total|Total of all reporting groups
253019|NCT01212159|B2|Baseline|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.
Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
253020|NCT01212159|B1|Baseline|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
253021|NCT01212159|P2|Participant Flow|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.
Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
253022|NCT01212159|P1|Participant Flow|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
253023|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.
Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
253024|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
253025|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.
Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
253026|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
253027|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.
Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
253028|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
253029|NCT01212159|E2|Reported Event|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.
Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
253030|NCT01212159|E1|Reported Event|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
253031|NCT01212094|B4|Baseline|Total|Total of all reporting groups
253032|NCT01212094|B3|Baseline|Baseline|Patients in their first year baseline prior to treatment phase
253033|NCT01212094|B2|Baseline|Rituximab|Group administered active drug
253034|NCT01212094|B1|Baseline|Placebo|Group administered placebo
253035|NCT01212094|P3|Participant Flow|Rituximab|Group administered active drug
253036|NCT01212094|P2|Participant Flow|Placebo|Group administered placebo
253037|NCT01212094|P1|Participant Flow|Baseline|Patients in their first year baseline prior to study drug phase
253038|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
253039|NCT01212094|O1|Outcome|Placebo|Group administered placebo
253040|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
253041|NCT01212094|O1|Outcome|Placebo|Group administered placebo
253042|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
253043|NCT01212094|O1|Outcome|Placebo|Group administered placebo
253044|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
253045|NCT01212094|O1|Outcome|Placebo|Group administered placebo
253046|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
253047|NCT01212094|O1|Outcome|Placebo|Group administered placebo
253048|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
253049|NCT01212094|O1|Outcome|Placebo|Group administered placebo
253050|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
253051|NCT01212094|O1|Outcome|Placebo|Group administered placebo
253052|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
253053|NCT01212094|O1|Outcome|Placebo|Group administered placebo
253054|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
253055|NCT01212094|O1|Outcome|Placebo|Group administered placebo
253056|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
253064|NCT01212094|E3|Reported Event|Baseline|Patients in their first year baseline prior to study drug phase
253065|NCT01212094|E2|Reported Event|Rituximab|Group who got active drug
253066|NCT01212094|E1|Reported Event|Placebo|Placebo group
253067|NCT01211873|B4|Baseline|Total|Total of all reporting groups
253068|NCT01211873|B3|Baseline|Dotarem 2 (Gadoterate Meglumine )|All children were assigned to Dotarem
253069|NCT01211873|B2|Baseline|Dotarem (Gadoterate Meglumine )|adults received Dotarem as 2:1 ratio compared to Magnevist.
253070|NCT01211873|B1|Baseline|Magnevist (Gadopentetate Dimeglumine)|adults received Magnevist as 1:2 ratio compared to Dotarem
253071|NCT01211873|P3|Participant Flow|Dotarem 2 (Gadoterate Meglumine )|Pediatric patients were assigned to Dotarem group only
253072|NCT01211873|P2|Participant Flow|Magnevist (Gadopentetate Dimeglumine)|Dotarem and Magnevist were randomised as 2:1 ratio
253073|NCT01211873|P1|Participant Flow|Dotarem (Gadoterate Meglumine )|Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.
253074|NCT01211873|O2|Outcome|Dotarem (Gadoterate Meglumine ) PAIRED|all sequences pre and post injection wil be pooled as PAIRED
253075|NCT01211873|O1|Outcome|Dotarem (Gadoterate Meglumine ) PRE|any sequence acquired prior to injection will be pooled as PRE
253076|NCT01211873|E3|Reported Event|Dotarem 2 (Gadoterate Meglumine )|children were only assigned to Dotarem
253077|NCT01211873|E2|Reported Event|Magnevist (Gadopentetate Dimeglumine)|Dotarem and Magnevist were randomised as 2:1 ratio
253078|NCT01211873|E1|Reported Event|Dotarem (Gadoterate Meglumine )|Dotarem and Magnevist were randomised as 2:1 ratio for adults
253079|NCT01211769|B5|Baseline|Total|Total of all reporting groups
253080|NCT01211769|B4|Baseline|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg"
253081|NCT01211769|B3|Baseline|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
253082|NCT01211769|B2|Baseline|Naltrexone|"Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253083|NCT01211769|B1|Baseline|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253084|NCT01211769|P4|Participant Flow|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg"
253085|NCT01211769|P3|Participant Flow|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
253086|NCT01211769|P2|Participant Flow|Naltrexone|"Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253087|NCT01211769|P1|Participant Flow|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253088|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg"
253089|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
253090|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253091|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253092|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg"
253093|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
253094|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253095|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253096|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg"
253097|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
253098|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253099|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253644|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253100|NCT01211769|E4|Reported Event|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg"
253101|NCT01211769|E3|Reported Event|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
253102|NCT01211769|E2|Reported Event|Naltrexone|"Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253103|NCT01211769|E1|Reported Event|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
253104|NCT01211730|B3|Baseline|Total|Total of all reporting groups
253105|NCT01211730|B2|Baseline|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253106|NCT01211730|B1|Baseline|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253107|NCT01211730|P2|Participant Flow|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253108|NCT01211730|P1|Participant Flow|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253109|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253110|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253111|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253112|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253113|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253114|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253115|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253116|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253117|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253118|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253119|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253120|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253121|NCT01211730|E2|Reported Event|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253122|NCT01211730|E1|Reported Event|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
253123|NCT01211665|B3|Baseline|Total|Total of all reporting groups
253124|NCT01211665|B2|Baseline|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253125|NCT01211665|B1|Baseline|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253126|NCT01211665|P2|Participant Flow|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253127|NCT01211665|P1|Participant Flow|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253645|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253128|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253129|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253130|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253131|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253132|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253133|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253134|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253135|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253136|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253137|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253138|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253139|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253140|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253141|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253142|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253143|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253144|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253145|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253146|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253147|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253148|NCT01211665|E2|Reported Event|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
253149|NCT01211665|E1|Reported Event|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
253150|NCT01211613|B4|Baseline|Total|Total of all reporting groups
253151|NCT01211613|B3|Baseline|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
253646|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253152|NCT01211613|B2|Baseline|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
253153|NCT01211613|B1|Baseline|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
253154|NCT01211613|P3|Participant Flow|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
253155|NCT01211613|P2|Participant Flow|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
253156|NCT01211613|P1|Participant Flow|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
253157|NCT01211613|O3|Outcome|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
253158|NCT01211613|O2|Outcome|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
253159|NCT01211613|O1|Outcome|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
253160|NCT01211613|O3|Outcome|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
253161|NCT01211613|O2|Outcome|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
253162|NCT01211613|O1|Outcome|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
253163|NCT01211613|E3|Reported Event|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
253164|NCT01211613|E2|Reported Event|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
253165|NCT01211613|E1|Reported Event|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
253166|NCT01211535|B3|Baseline|Total|Total of all reporting groups
253167|NCT01211535|B2|Baseline|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
253168|NCT01211535|B1|Baseline|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
253169|NCT01211535|P2|Participant Flow|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
253170|NCT01211535|P1|Participant Flow|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
253171|NCT01211535|O2|Outcome|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
253172|NCT01211535|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
253173|NCT01211535|E2|Reported Event|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
253174|NCT01211535|E1|Reported Event|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
253175|NCT01211340|B3|Baseline|Total|Total of all reporting groups
253176|NCT01211340|B2|Baseline|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting
ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
253177|NCT01211340|B1|Baseline|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
253178|NCT01211340|P2|Participant Flow|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting
ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
253179|NCT01211340|P1|Participant Flow|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
253180|NCT01211340|O2|Outcome|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting
ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
253181|NCT01211340|O1|Outcome|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
253182|NCT01211340|O2|Outcome|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting
ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
253183|NCT01211340|O1|Outcome|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
253184|NCT01211340|O2|Outcome|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting
ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
253185|NCT01211340|O1|Outcome|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
253186|NCT01211340|E2|Reported Event|Intervention Arm|"These caregivers will receive usual care plus the technology which allows them to participate in their plan of care meeting
ACTIVE: Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient"
253187|NCT01211340|E1|Reported Event|Usual Care|This arm serves as the control, individuals will not receive the intervention but will receive all measures
253188|NCT01211197|B1|Baseline|Study Overall|"An open label, randomised, three-way crossover study. The three treatments administered were
Fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions
12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions
Fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions
A washout period of at least 7 days was respected between drug administrations."
253189|NCT01211197|P6|Participant Flow|FDC Fed / Individual Tablets Fasted / FDC Fasted|"Patients received the three treatments in the following order:
FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions
12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions
FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions"
253190|NCT01211197|P5|Participant Flow|FDC Fed / FDC Fasted / Individual Tablets Fasted|"Patients received the three treatments in the following order:
FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions
FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions
12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions"
253191|NCT01211197|P4|Participant Flow|Individual Tablets Fasted / FDC Fed / FDC Fasted|"Patients received the three treatments in the following order:
12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions
FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions
FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions"
253192|NCT01211197|P3|Participant Flow|Individual Tablets Fasted / FDC Fasted / FDC Fed|"Patients received the three treatments in the following order:
12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions
FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions
FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions"
253193|NCT01211197|P2|Participant Flow|FDC Fasted / FDC Fed / Individual Tablets Fasted|"Patients received the three treatments in the following order:
FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions
FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions
12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions"
253194|NCT01211197|P1|Participant Flow|FDC Fasted / Individual Tablets Fasted / FDC Fed|"Patients received the three treatments in the following order:
FDC tablet, containing 12.5mg empagliflozin (BI 10773) and 1000mg metformin, under fasted conditions
12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions
FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions"
253195|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253196|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253197|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253198|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
301133|NCT00162136|O4|Outcome|Grade 3|Severe
253199|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253200|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253201|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253202|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253203|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253204|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253205|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253206|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253207|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253208|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253209|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253210|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253211|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253212|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253213|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253214|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253215|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253216|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253217|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253218|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253219|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253220|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253221|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253222|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253223|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253224|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253225|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253226|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253227|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253228|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253229|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253230|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253231|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
253232|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253233|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253234|NCT01211197|E3|Reported Event|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253235|NCT01211197|E2|Reported Event|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
253236|NCT01211197|E1|Reported Event|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
253237|NCT01211184|B4|Baseline|Total|Total of all reporting groups
253238|NCT01211184|B3|Baseline|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
253239|NCT01211184|B2|Baseline|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
253240|NCT01211184|B1|Baseline|Fasting|patients undergo surgery in the fasting state
253241|NCT01211184|P3|Participant Flow|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
253242|NCT01211184|P2|Participant Flow|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
253243|NCT01211184|P1|Participant Flow|Fasting|patients undergo surgery in the fasting state
253647|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253244|NCT01211184|O3|Outcome|Nutrition Group|Drank a carbohydrate drink 800 ml in the evening before surgery and 400 ml 2 hrs before surgery
253245|NCT01211184|O2|Outcome|Water Group|Patients drank 800 ml of water 2 hrs before surgery
253246|NCT01211184|O1|Outcome|Fasting|Fasting before surgery
253247|NCT01211184|O3|Outcome|Nutrition Group|Patients drank 800 ml in the evening before surgery and 400 ml 2 hours before surgery of a commercially available carbohydrate drink (PreOp)
253248|NCT01211184|O2|Outcome|Water Group|Patients drank 800 ml of tap water 2 hrs before entering the operating room
253249|NCT01211184|O1|Outcome|Fasting Group|Patients did not ingest any drink or food from midnight before the surgery.
253250|NCT01211184|E3|Reported Event|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
253251|NCT01211184|E2|Reported Event|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
253252|NCT01211184|E1|Reported Event|Fasting|patients undergo surgery in the fasting state
253253|NCT01211145|B5|Baseline|Total|Total of all reporting groups
253254|NCT01211145|B4|Baseline|ZOMIG 5 mg|ZOMIG nasal spray
253255|NCT01211145|B3|Baseline|ZOMIG 2.5 mg|ZOMIG nasal spray
253256|NCT01211145|B2|Baseline|ZOMIG 0.5 mg|ZOMIG nasal spray
253257|NCT01211145|B1|Baseline|Placebo|Placebo to ZOMIG nasal spray
253258|NCT01211145|P4|Participant Flow|ZOMIG 5 mg|ZOMIG nasal spray
253259|NCT01211145|P3|Participant Flow|ZOMIG 2.5 mg|ZOMIG nasal spray
253260|NCT01211145|P2|Participant Flow|ZOMIG 0.5 mg|ZOMIG nasal spray
253261|NCT01211145|P1|Participant Flow|Placebo|Placebo to ZOMIG nasal spray
253262|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
253263|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
253264|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
253265|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
253266|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
253267|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
253268|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
253269|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
253270|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
253271|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
253272|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
253273|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
253274|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
253275|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
253276|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
253277|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
253278|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
253279|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
253280|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
253281|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
253282|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
253283|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
253284|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
253285|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
253286|NCT01211145|E4|Reported Event|ZOMIG 5 mg|ZOMIG nasal spray
253287|NCT01211145|E3|Reported Event|ZOMIG 2.5 mg|ZOMIG nasal spray
253288|NCT01211145|E2|Reported Event|ZOMIG 0.5 mg|ZOMIG nasal spray
253289|NCT01211145|E1|Reported Event|Placebo|Placebo to ZOMIG nasal spray
253290|NCT01211106|B3|Baseline|Total|Total of all reporting groups
253291|NCT01211106|B2|Baseline|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
253292|NCT01211106|B1|Baseline|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
253293|NCT01211106|P2|Participant Flow|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
253294|NCT01211106|P1|Participant Flow|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
253295|NCT01211106|O2|Outcome|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
253296|NCT01211106|O1|Outcome|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
253297|NCT01211106|O2|Outcome|Arm 2 Sequential Therapy|MET followed by Prolonged Exposure
253298|NCT01211106|O1|Outcome|Arm 1: Integrated Conditions|Motivational enhancement therapy combined with Prolonged Exposure therapy.
253299|NCT01211106|E2|Reported Event|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
253300|NCT01211106|E1|Reported Event|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
253301|NCT01210820|B3|Baseline|Total|Total of all reporting groups
253302|NCT01210820|B2|Baseline|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.
iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
253303|NCT01210820|B1|Baseline|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.
iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
253304|NCT01210820|P2|Participant Flow|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.
iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser"
253305|NCT01210820|P1|Participant Flow|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.
iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser"
301134|NCT00162136|O3|Outcome|Grade 2|Moderate
253306|NCT01210820|O2|Outcome|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.
iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
253307|NCT01210820|O1|Outcome|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.
iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
253308|NCT01210820|O2|Outcome|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.
iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
253309|NCT01210820|O1|Outcome|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.
iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
253310|NCT01210820|E2|Reported Event|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.
iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
253311|NCT01210820|E1|Reported Event|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.
iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
253312|NCT01210807|B3|Baseline|Total|Total of all reporting groups
253313|NCT01210807|B2|Baseline|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
253314|NCT01210807|B1|Baseline|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
253315|NCT01210807|P2|Participant Flow|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
253316|NCT01210807|P1|Participant Flow|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
253317|NCT01210807|O2|Outcome|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
253318|NCT01210807|O1|Outcome|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
253319|NCT01210807|O2|Outcome|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
253320|NCT01210807|O1|Outcome|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
253321|NCT01210807|E2|Reported Event|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
253322|NCT01210807|E1|Reported Event|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
253323|NCT01210716|B1|Baseline|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
253324|NCT01210716|P2|Participant Flow|AMICUS First, Then Spectra|Patients randomized to Test (AMICUS) procedure first. Second procedure performed was Control (Spectra).
253325|NCT01210716|P1|Participant Flow|Spectra First, Then AMICUS|Patients randomized to Control (Spectra) procedure first. Second procedure performed was Test (AMICUS).
253326|NCT01210716|O1|Outcome|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
253327|NCT01210716|O2|Outcome|Spectra (Control)|Each evaluable patient underwent one complete TPE procedure on the COBE Spectra separator.
253328|NCT01210716|O1|Outcome|AMICUS (Test)|Each evaluable patient underwent one complete TPE procedure on the AMICUS separator.
253329|NCT01210716|E1|Reported Event|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
253330|NCT01210690|B1|Baseline|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253331|NCT01210690|P1|Participant Flow|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253332|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253333|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and is not influenced by the study protocol.
253334|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253335|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253648|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253336|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253337|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253338|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253339|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253340|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253341|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253342|NCT01210690|E1|Reported Event|Patients, 1 - 11 Mths Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
253343|NCT01210651|B3|Baseline|Total|Total of all reporting groups
253344|NCT01210651|B2|Baseline|Attention Control Education Group|Participants in this group met for 90-minute education seminars on yoga history twice a week for a total of 8 weeks.
253345|NCT01210651|B1|Baseline|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
253346|NCT01210651|P2|Participant Flow|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
253347|NCT01210651|P1|Participant Flow|Hatha Yoga Practice Group|Participants in this group met for 90-minute yoga practice sessions twice a weekly for a total of 8 weeks.
253348|NCT01210651|O2|Outcome|Attention Control Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
253349|NCT01210651|O1|Outcome|Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
253350|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
253351|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
253352|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
253353|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
253354|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
253355|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
253356|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
253357|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.
253358|NCT01210651|E2|Reported Event|Attention Control Group|Participants in this group met for 90-minute education seminars on yoga history and philosophy twice a week for a total of 8 weeks.
253359|NCT01210651|E1|Reported Event|Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks. week for a total of 8 weeks.
253360|NCT01210495|B5|Baseline|Total|Total of all reporting groups
253361|NCT01210495|B4|Baseline|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253649|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
301135|NCT00162136|O2|Outcome|Grade 1|Mild
253362|NCT01210495|B3|Baseline|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253363|NCT01210495|B2|Baseline|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
253364|NCT01210495|B1|Baseline|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
253365|NCT01210495|P4|Participant Flow|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253366|NCT01210495|P3|Participant Flow|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253367|NCT01210495|P2|Participant Flow|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
253368|NCT01210495|P1|Participant Flow|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg twice daily (BID).
253369|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253370|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253371|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253372|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253373|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
253374|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
253375|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
253376|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
253377|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
253378|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
253379|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253650|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253651|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253380|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253381|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253382|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253383|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253384|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253385|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253386|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253387|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253388|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253389|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253390|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253391|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253392|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253411|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
301136|NCT00162136|O1|Outcome|Grade 0|Absent
253393|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253394|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253395|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253396|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253397|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253398|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253399|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253400|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253401|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
253402|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
253403|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
253404|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
253405|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
253406|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
253407|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
253408|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
253409|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
253410|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
253412|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
301137|NCT00162136|O3|Outcome|All Grades|Grades 1-4
253413|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253414|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253415|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253416|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253417|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253418|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253419|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253420|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253421|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253422|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253423|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253424|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253425|NCT01210495|E4|Reported Event|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
253578|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
301150|NCT00162136|E2|Reported Event|Ixa 20 mg/m2|
253426|NCT01210495|E3|Reported Event|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
253427|NCT01210495|E2|Reported Event|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non randomized portion of this study to determine the recommended starting dose of axitinib for this population.
253428|NCT01210495|E1|Reported Event|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg twice daily (BID).
253429|NCT01210443|B1|Baseline|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
253430|NCT01210443|P1|Participant Flow|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
253431|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
253432|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
253433|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
253434|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
253435|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
253436|NCT01210443|E1|Reported Event|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
253437|NCT01210170|B1|Baseline|All Study Participants|• participant with asthma were enrolled in the study
253438|NCT01210170|P1|Participant Flow|All Study Participants|"• Inhalation of 400 µg mometasone DPI 30 min before inhalation of 180 µg albuterol
Mometasone furoate: • Inhalation of 400 µg mometasone or placebo DPI 30 min before inhalation of 180 µg albuterol
• Inhalation of 400 µg mometasone or placebo DPI 60 min before inhalation of 180 µg albuterol"
253439|NCT01210170|O4|Outcome|Mometasone Placebo and Albuterol Simultaneously|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.
253440|NCT01210170|O3|Outcome|Mometasone and Albuterol Simultaneously|inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol.
253441|NCT01210170|O2|Outcome|Mometasone Placebo 30 Minutes Before Albuterol|Inhalation of mometasone placebo 30 min before inhalation of 180 µg albuterol
253442|NCT01210170|O1|Outcome|Mometasone 30 Minutes Before Albuterol|• Inhalation of 400 µg mometasone 30 min before inhalation of 180 µg albuterol
253443|NCT01210170|O7|Outcome|All Participants Received Placebo -60 Min|placebo 60 minutes before inhalation of 180 mcg of albuterol
253444|NCT01210170|O6|Outcome|All Participants Received 400 mcg -60 Min|mometasone 400 mcg 60 minutes before inhalation of 180 mcg of albuterol
253445|NCT01210170|O5|Outcome|All Participants Received 200 mcg Mometasone-30 Min|mometasone 200 mcg 30 minutes before inhalation of 180 mcg of albuterol
253446|NCT01210170|O4|Outcome|All Participants Received Placebo Simultaneously With Albutero|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.
253447|NCT01210170|O3|Outcome|All Participants Received 400 mcg Mometasone Simultaneous|inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol
253448|NCT01210170|O2|Outcome|All Participants Received Placebo 30 Minutes Before Albuterol|mometasone placebo 30 minutes before albuterol 180 mcg inhalation
253449|NCT01210170|O1|Outcome|All Participants Received 400 mcg Mometasone-30 Min|mometasone 400 mcg 30 minutes before albuterol 180 mcg inhalation
253450|NCT01210170|E1|Reported Event|All Study Participants|Simultaneous inhalation of 400 µg mometasone DPI and 180 µg albuterol
253451|NCT01210144|B3|Baseline|Total|Total of all reporting groups
253452|NCT01210144|B2|Baseline|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
253487|NCT01210118|E2|Reported Event|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
301151|NCT00162136|E1|Reported Event|Ixa 10 mg/m2|
253453|NCT01210144|B1|Baseline|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
253454|NCT01210144|P2|Participant Flow|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
253455|NCT01210144|P1|Participant Flow|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) gonadotropin-releasing hormone (GnRH) agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
253456|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
253457|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
253458|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
253459|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
253460|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
253461|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
253533|NCT01209780|B1|Baseline|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
253462|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
253463|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
253464|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
253465|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
253466|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
253467|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
253468|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
253469|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
253470|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle®|Participants received 150 IU per day of r-hFSH (Gonal-F®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm [for both long agonist and multi-dose antagonist protocol], and with E2>1 mcg/L [for long agonist protocol]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation, either 0.1 mg GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) in long agonist protocol or 0.25 mg GnRH antagonist daily was started from Day 6 of GONAL-f® stimulation treatment in multi-dose antagonist protocol, as per SmPC.
253486|NCT01210118|O1|Outcome|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
253471|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle®|Participants received 150 IU per day of r-hFSH (Gonal-F®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm [for both long agonist and multi-dose antagonist protocol], and with E2>1 mcg/L [for long agonist protocol]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation, either 0.1 mg GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) in long agonist protocol or 0.25 mg GnRH antagonist daily was started from Day 6 of GONAL-f® stimulation treatment in multi-dose antagonist protocol, as per SmPC.
253472|NCT01210144|E2|Reported Event|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
253473|NCT01210144|E1|Reported Event|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
253474|NCT01210118|B3|Baseline|Total|Total of all reporting groups
253475|NCT01210118|B2|Baseline|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
253476|NCT01210118|B1|Baseline|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
253477|NCT01210118|P2|Participant Flow|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
253478|NCT01210118|P1|Participant Flow|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
253479|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
253480|NCT01210118|O1|Outcome|High Intensity Intervention|Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the
253481|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
253482|NCT01210118|O1|Outcome|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
253483|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
253484|NCT01210118|O1|Outcome|High Intensity Intervention|Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the
253485|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
253534|NCT01209780|P5|Participant Flow|Control (9-17 Years)|All subjects in this group were non-naive and received one dose of US licensed control vaccine TIVf.
253488|NCT01210118|E1|Reported Event|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
253489|NCT01210079|B3|Baseline|Total|Total of all reporting groups
253490|NCT01210079|B2|Baseline|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
253491|NCT01210079|B1|Baseline|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
253492|NCT01210079|P2|Participant Flow|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
253493|NCT01210079|P1|Participant Flow|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
253494|NCT01210079|O2|Outcome|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
253495|NCT01210079|O1|Outcome|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
253496|NCT01210079|E2|Reported Event|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
253497|NCT01210079|E1|Reported Event|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
253498|NCT01210001|B4|Baseline|Total|Total of all reporting groups
253499|NCT01210001|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
253500|NCT01210001|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
253501|NCT01210001|B1|Baseline|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
253502|NCT01210001|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
253503|NCT01210001|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
253504|NCT01210001|P1|Participant Flow|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
253505|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
253506|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
253507|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
253508|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
253509|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
253510|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
253511|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
253512|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
253513|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
253514|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
253515|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
253516|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
253517|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
253518|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
253519|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
253520|NCT01210001|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
253521|NCT01210001|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
253522|NCT01210001|E1|Reported Event|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
253523|NCT01209949|B1|Baseline|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
253524|NCT01209949|P1|Participant Flow|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
253525|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
253526|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
253527|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
253528|NCT01209949|E1|Reported Event|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
253529|NCT01209780|B5|Baseline|Total|Total of all reporting groups
253530|NCT01209780|B4|Baseline|Control (9-17 Years)|All subjects received one dose of control TIV (eTIV_f).
253531|NCT01209780|B3|Baseline|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
253532|NCT01209780|B2|Baseline|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of vaccine.
253535|NCT01209780|P4|Participant Flow|TIV (9-17 Years)|All subjects in this group were non-naive and received one dose of investigational TIV.
253652|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253536|NCT01209780|P3|Participant Flow|Control (3 to < 4 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination.The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- comparator TIV.
253537|NCT01209780|P2|Participant Flow|Control (4-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- TIVf.
253538|NCT01209780|P1|Participant Flow|TIV (3-8 Years Old)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
253539|NCT01209780|O4|Outcome|Control (9-17 Years)|All subjects received one dose of control vaccine (TIVf).
253540|NCT01209780|O3|Outcome|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
253541|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
253542|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
253543|NCT01209780|O4|Outcome|Control (9-17 Years)|All subjects received one dose of control vaccine(TIVf).
253544|NCT01209780|O3|Outcome|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
253545|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
253546|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
253547|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to <4 years)] consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of control vaccine. Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received two doses of comparator TIV.
253548|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of investigational TIV.
253549|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to <4 years)] consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of control vaccine. Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received two doses of comparator TIV.
253550|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of investigational TIV.
253551|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
253552|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
253553|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
253554|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
253555|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
253556|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
253653|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253557|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
253558|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
253559|NCT01209780|E4|Reported Event|Control (9-17 Years)|All subjects received one dose of control vaccine (TIV_f).
253560|NCT01209780|E3|Reported Event|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
253561|NCT01209780|E2|Reported Event|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
253562|NCT01209780|E1|Reported Event|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
253563|NCT01209767|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.
cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together."
253564|NCT01209767|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.
cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together."
253565|NCT01209767|O3|Outcome|Control|Area that received no treatment
253566|NCT01209767|O2|Outcome|Subcision|Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
253567|NCT01209767|O1|Outcome|Cryolipolysis|cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
253568|NCT01209767|E3|Reported Event|Control|Nothing was done to the area.
253569|NCT01209767|E2|Reported Event|Subcision|Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
253570|NCT01209767|E1|Reported Event|Cryolipolysis|cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
253571|NCT01209702|B3|Baseline|Total|Total of all reporting groups
253572|NCT01209702|B2|Baseline|Combined Tocilizumab|Participants randomized in Part 1 and Part 2 to receive intravenous infusions of 4 mg/kg (in Part 2 only) or 8 mg/kg tocilizumab once every 4 weeks.
253573|NCT01209702|B1|Baseline|Combined Placebo|Participants in Part 1 and Part 2 who received intravenous infusions of placebo once every 4 weeks.
253574|NCT01209702|P4|Participant Flow|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253575|NCT01209702|P3|Participant Flow|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253576|NCT01209702|P2|Participant Flow|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253577|NCT01209702|P1|Participant Flow|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253654|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253655|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253579|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253580|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253581|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253582|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253583|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253584|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks.
253585|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks.
253586|NCT01209702|O1|Outcome|All Tocilizumab|Participants who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks in either Part 1 or Part 2, including participants randomized to placebo who switched or escaped to tocilizumab treatment.
253587|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253588|NCT01209702|O1|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253589|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253590|NCT01209702|O1|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253591|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253592|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253593|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253594|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253638|NCT01209689|E1|Reported Event|Tocilizumab|Patients randomized to tocilizumab who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks for 24 weeks and patients randomized to placebo who switched or escaped to tocilizumab treatment.
253639|NCT01209624|B1|Baseline|Xalatan®|Once daily as 1 drop (topical application) in the evening
253640|NCT01209624|P1|Participant Flow|Xalatan®|Once daily as 1 drop (topical application) in the evening
253595|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253596|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253597|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253598|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253599|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253600|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253601|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253602|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253603|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253604|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253605|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253606|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253607|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253608|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253609|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253610|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253611|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253641|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253612|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253613|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253614|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253615|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253616|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253617|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253618|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253619|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
253620|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253621|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253622|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks.
253623|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks.
253624|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12.
253625|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12.
253626|NCT01209702|E4|Reported Event|All Tocilizumab|Participants who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks in either Part 1 or Part 2. This group includes participants randomized to placebo who switched or escaped to tocilizumab treatment for whom adverse events are reported after the start of treatment with tocilizumab.
253627|NCT01209702|E3|Reported Event|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks. AEs reported only until participants escaped or switched to tocilizumab.
253628|NCT01209702|E2|Reported Event|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253629|NCT01209702|E1|Reported Event|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
253630|NCT01209689|B3|Baseline|Total|Total of all reporting groups
253631|NCT01209689|B2|Baseline|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
253632|NCT01209689|B1|Baseline|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
253633|NCT01209689|P2|Participant Flow|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
253634|NCT01209689|P1|Participant Flow|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
253635|NCT01209689|O2|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
253636|NCT01209689|O1|Outcome|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
253637|NCT01209689|E2|Reported Event|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
253656|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253657|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253658|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253659|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253660|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253661|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253662|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253663|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253664|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253665|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253666|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253667|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253668|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
253669|NCT01209624|E1|Reported Event|Xalatan®|Once daily as 1 drop (topical application) in the evening
253670|NCT01209520|B1|Baseline|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
253671|NCT01209520|P1|Participant Flow|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
253672|NCT01209520|O1|Outcome|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
253673|NCT01209520|O1|Outcome|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
253674|NCT01209520|E1|Reported Event|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
253675|NCT01209286|B4|Baseline|Total|Total of all reporting groups
253676|NCT01209286|B3|Baseline|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253677|NCT01209286|B2|Baseline|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253727|NCT01209286|E4|Reported Event|Blinatumomab Overall|All participants who received blinatumomab by continuous intravenous infusion during the core study.
253678|NCT01209286|B1|Baseline|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253679|NCT01209286|P3|Participant Flow|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253680|NCT01209286|P2|Participant Flow|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253681|NCT01209286|P1|Participant Flow|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253682|NCT01209286|O1|Outcome|Blinatumomab|All participants who received blinatumomab.
253683|NCT01209286|O1|Outcome|Blinatumomab|All participants who received blinatumomab.
253684|NCT01209286|O3|Outcome|Blinatumomab 30 μg|Participants receiving blinatumomab 30 μg/m²/day.
253685|NCT01209286|O2|Outcome|Blinatumomab 15 μg|Participants receiving blinatumomab 15 μg/m²/day.
253686|NCT01209286|O1|Outcome|Blinatumomab 5 μg|Participants receiving blinatumomab 5 μg/m²/day.
253687|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253688|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253689|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253690|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253691|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253692|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253693|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253694|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253695|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253696|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253697|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253698|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253699|NCT01209286|O4|Outcome|Blinatumimab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253700|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253701|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253702|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253703|NCT01209286|O4|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253763|NCT01209195|O2|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
253894|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253704|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253705|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253706|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253707|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253708|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253709|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253710|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253711|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253712|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253713|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253714|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253715|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253716|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253717|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253718|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253719|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253720|NCT01209286|O3|Outcome|ABlinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253721|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253722|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253723|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253724|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253725|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253726|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253889|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253728|NCT01209286|E3|Reported Event|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
253729|NCT01209286|E2|Reported Event|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
253730|NCT01209286|E1|Reported Event|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
253731|NCT01209260|B3|Baseline|Total|Total of all reporting groups
253732|NCT01209260|B2|Baseline|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
253733|NCT01209260|B1|Baseline|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
253734|NCT01209260|P2|Participant Flow|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
253735|NCT01209260|P1|Participant Flow|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
253736|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle
253737|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle
253738|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle
253739|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle
253740|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
253741|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
253742|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
253743|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
253744|NCT01209260|E2|Reported Event|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
253745|NCT01209260|E1|Reported Event|Radiofrequency Energy Needle (RF)|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
253746|NCT01209195|B3|Baseline|Total|Total of all reporting groups
253747|NCT01209195|B2|Baseline|MM-121 + Paclitaxel: Expansion Cohort|MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
253748|NCT01209195|B1|Baseline|MM-121 + Paclitaxel: Dose Escalation|"MM-121 plus Paclitaxel: Cohort 1:
MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
Cohort 2:
MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
Intermediate doses between cohorts 1 and 2 may also be considered."
253749|NCT01209195|P6|Participant Flow|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest
Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
253750|NCT01209195|P5|Participant Flow|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW
Paclitaxel: 80 mg/m2 weekly IV"
253751|NCT01209195|P4|Participant Flow|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose
Paclitaxel: 80 mg/m2 weekly IV"
253752|NCT01209195|P3|Participant Flow|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV
Paclitaxel - 80mg/m2 weekly IV"
253753|NCT01209195|P2|Participant Flow|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV
Paclitaxel - 80mg/m2 weekly IV"
253754|NCT01209195|P1|Participant Flow|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
253755|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest
Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
253756|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW
Paclitaxel: 80 mg/m2 weekly IV"
253757|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose
Paclitaxel: 80 mg/m2 weekly IV"
253758|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV
Paclitaxel - 80mg/m2 weekly IV"
253759|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV
Paclitaxel - 80mg/m2 weekly IV"
253760|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
253761|NCT01209195|O4|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg + Rest Week|"MM-121: 40 mg/kg loading dose followed by seven 20mg/kg weekly doses and a rest week. This administration schedule spans two cycles and repeats for each subsequent 2-cycle unit.
Paclitaxel: 80 mg/m2"
253762|NCT01209195|O3|Outcome|MM-121 + Paclitaxel: 40 mg/kg Q2W|MM-121: 40 mg/kg Q2W Paclitaxel: 80 mg/m2
253764|NCT01209195|O1|Outcome|MM-121 + Paclitaxel: 20/12 mg/kg|MM-121: 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
253765|NCT01209195|O4|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg + Rest Week|"MM-121: 40 mg/kg loading dose followed by seven 20mg/kg weekly doses and a rest week. This administration schedule spans two cycles and repeats for each subsequent 2-cycle unit.
Paclitaxel: 80 mg/m2"
253766|NCT01209195|O3|Outcome|MM-121 + Paclitaxel: 40 mg/kg Q2W|MM-121: 40 mg/kg Q2W Paclitaxel: 80 mg/m2
253767|NCT01209195|O2|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
253768|NCT01209195|O1|Outcome|MM-121 + Paclitaxel: 20/12 mg/kg|MM-121: 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
253769|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest
Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
253770|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW
Paclitaxel: 80 mg/m2 weekly IV"
253771|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose
Paclitaxel: 80 mg/m2 weekly IV"
253772|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV
Paclitaxel - 80mg/m2 weekly IV"
253773|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV
Paclitaxel - 80mg/m2 weekly IV"
253774|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
253775|NCT01209195|O2|Outcome|Part 2: Expansion Cohorts|Additional exploratory doses of MM-121 and paclitaxel
253776|NCT01209195|O1|Outcome|Part 1: Dose Escalation|Escalating doses of MM-121 and paclitaxel
253777|NCT01209195|O2|Outcome|Part 2: Expansion Cohorts|Additional exploratory doses of MM-121 and paclitaxel
253778|NCT01209195|O1|Outcome|Part 1: Dose Escalation|Escalating doses of MM-121 and paclitaxel
253779|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest
Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
253780|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW
Paclitaxel: 80 mg/m2 weekly IV"
253781|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose
Paclitaxel: 80 mg/m2 weekly IV"
253782|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV
Paclitaxel - 80mg/m2 weekly IV"
253783|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV
Paclitaxel - 80mg/m2 weekly IV"
253784|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
253785|NCT01209195|E2|Reported Event|MM-121 + Paclitaxel: Expansion Cohort|"Cohort 1:
MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
Cohort 2:
MM-121 20 mg/kg IV loading dose x followed by 12 mg/kg IV QW maintenance dose Paclitaxel: 80 mg/m2 weekly IV
Cohort 3:
MM-121 40mg/kg IV QOW Paclitaxel: 80 mg/m2 weekly IV
Cohort 4:
MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
253786|NCT01209195|E1|Reported Event|MM-121 + Paclitaxel: Dose Escalation|"Cohort 1:
MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
Cohort 2:
MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV"
253787|NCT01209143|B3|Baseline|Total|Total of all reporting groups
253788|NCT01209143|B2|Baseline|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.
Vismodegib: Vismodegib was supplied in hard gelatin capsules.
Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
253789|NCT01209143|B1|Baseline|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.
Vismodegib: Vismodegib was supplied in hard gelatin capsules.
Rosiglitazone: Rosiglitazone was supplied in tablets."
253790|NCT01209143|P2|Participant Flow|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.
Vismodegib: Vismodegib was supplied in hard gelatin capsules.
Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
253791|NCT01209143|P1|Participant Flow|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.
Vismodegib: Vismodegib was supplied in hard gelatin capsules.
Rosiglitazone: Rosiglitazone was supplied in tablets."
253792|NCT01209143|O1|Outcome|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.
Vismodegib: Vismodegib was supplied in hard gelatin capsules.
Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
253890|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253891|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
301152|NCT00162266|B4|Baseline|Total|Total of all reporting groups
253793|NCT01209143|O1|Outcome|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.
Vismodegib: Vismodegib was supplied in hard gelatin capsules.
Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
253794|NCT01209143|O1|Outcome|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.
Vismodegib: Vismodegib was supplied in hard gelatin capsules.
Rosiglitazone: Rosiglitazone was supplied in tablets."
253795|NCT01209143|O1|Outcome|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.
Vismodegib: Vismodegib was supplied in hard gelatin capsules.
Rosiglitazone: Rosiglitazone was supplied in tablets."
253796|NCT01209143|E2|Reported Event|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.
Vismodegib: Vismodegib was supplied in hard gelatin capsules.
Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
253797|NCT01209143|E1|Reported Event|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.
Vismodegib: Vismodegib was supplied in hard gelatin capsules.
Rosiglitazone: Rosiglitazone was supplied in tablets."
253798|NCT01208961|B1|Baseline|All Subjects|All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
253799|NCT01208961|P2|Participant Flow|Lovaza-Epanova-Lovaza-Epanova|Lovaza (4 g) and Epanova (4 g) : Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Epanova (omefas),4x1g capsules, taken with high-fat meals
253800|NCT01208961|P1|Participant Flow|Epanova-Lovaza-Epanova-Lovaza|Epanova (4 g) and Lovaza (4 g) : Single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals
253801|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
253802|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
253803|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
253804|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
253805|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
253806|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
253807|NCT01208961|E1|Reported Event|All Subjects|All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
253808|NCT01208415|B1|Baseline|Zenith® Iliac Branch System|Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
253809|NCT01208415|P1|Participant Flow|Zenith® Iliac Branch System|Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
253810|NCT01208415|O1|Outcome|Device Implant|Endovascular repair for aortoiliac or iliac aneurysms.: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.
253811|NCT01208415|E1|Reported Event|Zenith® Iliac Branch System|Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
253812|NCT01208402|B3|Baseline|Total|Total of all reporting groups
253813|NCT01208402|B2|Baseline|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
253814|NCT01208402|B1|Baseline|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
253892|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253893|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253815|NCT01208402|P2|Participant Flow|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
253816|NCT01208402|P1|Participant Flow|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
253817|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
253818|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
253819|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
253820|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
253821|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
253822|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
253823|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
253824|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
253825|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
253826|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
253827|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
253828|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
253829|NCT01208402|E2|Reported Event|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
253830|NCT01208402|E1|Reported Event|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
253831|NCT01208337|B1|Baseline|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
253832|NCT01208337|P1|Participant Flow|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
253833|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
253834|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
253835|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
253836|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
253837|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
253838|NCT01208337|E1|Reported Event|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
253839|NCT01208233|B7|Baseline|Total|Total of all reporting groups
253840|NCT01208233|B6|Baseline|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253841|NCT01208233|B5|Baseline|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253842|NCT01208233|B4|Baseline|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
253843|NCT01208233|B3|Baseline|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253844|NCT01208233|B2|Baseline|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253845|NCT01208233|B1|Baseline|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253846|NCT01208233|P6|Participant Flow|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253847|NCT01208233|P5|Participant Flow|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253848|NCT01208233|P4|Participant Flow|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
253849|NCT01208233|P3|Participant Flow|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253850|NCT01208233|P2|Participant Flow|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253851|NCT01208233|P1|Participant Flow|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253852|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253853|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253854|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
253855|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253856|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
253857|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253858|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253859|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253860|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
253861|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253862|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
253863|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253864|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253865|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253866|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
253867|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253868|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
253869|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253870|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253871|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253872|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
253873|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253874|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
253875|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253876|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253877|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253878|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
253879|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253880|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
253881|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253882|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253883|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253884|NCT01208233|O3|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253885|NCT01208233|O2|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253886|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253887|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253888|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
301970|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
253895|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253896|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253897|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253898|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253899|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253900|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253901|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253902|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253903|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253904|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253905|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253906|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253907|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253908|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253909|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253910|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253911|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253912|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253913|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253914|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253915|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253916|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253917|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253918|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253919|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253920|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253921|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
253922|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253923|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253924|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253925|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253926|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253927|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
253928|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253929|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253930|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253931|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253932|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253933|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
253934|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253935|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253936|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253937|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253938|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253939|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
253940|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253941|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253942|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253943|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253944|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253945|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
253946|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253947|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
301971|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
253948|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253949|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253950|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253951|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
253952|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253953|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253954|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253955|NCT01208233|E6|Reported Event|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
253956|NCT01208233|E5|Reported Event|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
253957|NCT01208233|E4|Reported Event|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
253958|NCT01208233|E3|Reported Event|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
253959|NCT01208233|E2|Reported Event|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
253960|NCT01208233|E1|Reported Event|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
253961|NCT01208220|B3|Baseline|Total|Total of all reporting groups
253962|NCT01208220|B2|Baseline|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
Collagenase Santyl : Topical enzyme applied to wound tissue"
253963|NCT01208220|B1|Baseline|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer
NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
253964|NCT01208220|P2|Participant Flow|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
Collagenase Santyl : Topical enzyme applied to wound tissue"
253965|NCT01208220|P1|Participant Flow|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer
NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
253966|NCT01208220|O2|Outcome|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
Collagenase Santyl : Topical enzyme applied to wound tissue"
253967|NCT01208220|O1|Outcome|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer
NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
253968|NCT01208220|O2|Outcome|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
Collagenase Santyl : Topical enzyme applied to wound tissue"
253969|NCT01208220|O1|Outcome|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer
NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
253970|NCT01208220|E2|Reported Event|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
Collagenase Santyl : Topical enzyme applied to wound tissue"
253971|NCT01208220|E1|Reported Event|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer
NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
253972|NCT01208207|B4|Baseline|Total|Total of all reporting groups
253973|NCT01208207|B3|Baseline|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily
253974|NCT01208207|B2|Baseline|Etoricoxib 90 mg|Etoricoxib 90 mg once daily
253975|NCT01208207|B1|Baseline|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily
253976|NCT01208207|P7|Participant Flow|Naproxen 1000 mg (Part II)|A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
253977|NCT01208207|P6|Participant Flow|Etoricoxib 90 mg / 90 mg (Part II)|A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
253978|NCT01208207|P5|Participant Flow|Etoricoxib 60 mg / 90 mg (Part II)|An increase of etoricoxib to 90 mg for 20 weeks (Part II)
253979|NCT01208207|P4|Participant Flow|Etoricoxib 60 mg / 60 mg (Part II)|A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
253980|NCT01208207|P3|Participant Flow|Naproxen 1000 mg (Part I)|Naproxen 500 mg oral tablet twice daily for 6 weeks
253981|NCT01208207|P2|Participant Flow|Etoricoxib 90 mg (Part I)|Etoricoxib 90 mg oral tablet once daily for 6 weeks
253982|NCT01208207|P1|Participant Flow|Etoricoxib 60 mg (Part I)|Etoricoxib 60 mg oral tablet once daily for 6 weeks
253983|NCT01208207|O7|Outcome|Naproxen 1000 mg (Part II)|A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
253984|NCT01208207|O6|Outcome|Etoricoxib 90 mg / 90 mg (Part II)|A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
253985|NCT01208207|O5|Outcome|Etoricoxib 60 mg / 90 mg (Part II)|An increase of etoricoxib to 90 mg for 20 weeks (Part II)
253986|NCT01208207|O4|Outcome|Etoricoxib 60 mg / 60 mg (Part II)|A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
253987|NCT01208207|O3|Outcome|Naproxen 1000 mg (Part I)|Naproxen 500 mg oral tablet twice daily for 6 weeks
253988|NCT01208207|O2|Outcome|Etoricoxib 90 mg (Part I)|Etoricoxib 90 mg oral tablet once daily for 6 weeks
253989|NCT01208207|O1|Outcome|Etoricoxib 60 mg (Part I)|Etoricoxib 60 mg oral tablet once daily for 6 weeks
253990|NCT01208207|O2|Outcome|Etoricoxib 60 mg / 60 mg|Etoricoxib 60 mg in Part I and Etoricoxib 60 mg in Part II
253991|NCT01208207|O1|Outcome|Etoricoxib 60 mg/ 90 mg|Etoricoxib 60 mg in Part I and Etoricoxib 90 mg in Part II
253992|NCT01208207|O2|Outcome|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily for 6 weeks
253993|NCT01208207|O1|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg oral tablet once daily for 6 weeks
253994|NCT01208207|O2|Outcome|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily for 6 weeks
253995|NCT01208207|O1|Outcome|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily for 6 weeks
301972|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
253996|NCT01208207|O2|Outcome|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily for 6 weeks
253997|NCT01208207|O1|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg oral tablet once daily for 6 weeks
253998|NCT01208207|E7|Reported Event|Naproxen 1000 mg|Participants who received at least one dose of Naproxen 1000 mg in Part I, but no drug in Part II.
253999|NCT01208207|E6|Reported Event|Etoricoxib 90 mg|Participants who received at least one dose of Etoricoxib 90 mg in Part I, but no drug in Part II.
254000|NCT01208207|E5|Reported Event|Etoricoxib 60 mg|Participants who received at least one dose of Etoricoxib 60 mg in Part I, but no drug in Part II.
254001|NCT01208207|E4|Reported Event|Naproxen 1000 mg / Naproxen 1000 mg|Participants who received Naproxen 1000 mg in Part I and at least one dose of Naproxen 1000 mg in Part II.
254002|NCT01208207|E3|Reported Event|Etoricoxib 90 mg / Etoricoxib 90 mg|Participants who received Etoricoxib 90 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
254003|NCT01208207|E2|Reported Event|Etoricoxib 60 mg / Etoricoxib 90 mg|Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
254004|NCT01208207|E1|Reported Event|Etoricoxib 60 mg / Etoricoxib 60 mg|Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 60 mg in Part II.
254005|NCT01208181|B4|Baseline|Total|Total of all reporting groups
254006|NCT01208181|B3|Baseline|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
254007|NCT01208181|B2|Baseline|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
254008|NCT01208181|B1|Baseline|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
254009|NCT01208181|P5|Participant Flow|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
254010|NCT01208181|P4|Participant Flow|Etoricoxib 60/Etoricoxib 90mg|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
254011|NCT01208181|P3|Participant Flow|Etoricoxib 60 mg/Etoricoxib 60 mg|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
254012|NCT01208181|P2|Participant Flow|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
254013|NCT01208181|P1|Participant Flow|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
254014|NCT01208181|O5|Outcome|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
254015|NCT01208181|O4|Outcome|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
254016|NCT01208181|O3|Outcome|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
254017|NCT01208181|O2|Outcome|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
254018|NCT01208181|O1|Outcome|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
254019|NCT01208181|O5|Outcome|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
254020|NCT01208181|O4|Outcome|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
254021|NCT01208181|O3|Outcome|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
254022|NCT01208181|O2|Outcome|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
254023|NCT01208181|O1|Outcome|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
254024|NCT01208181|O2|Outcome|Etoricoxib 60 mg/Etoricoxib 90 mg|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part 1 and etoricoxib 90 mg tablets Part 2 of the study.
254025|NCT01208181|O1|Outcome|Etoricoxib 60 mg/Etoricoxib 60 mg|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part 1 and Part 2 of the study.
254026|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
254027|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
254028|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
254029|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
254030|NCT01208181|O3|Outcome|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
254031|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
254032|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
254033|NCT01208181|O3|Outcome|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
254034|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
254035|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
254036|NCT01208181|E5|Reported Event|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
254037|NCT01208181|E4|Reported Event|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
254038|NCT01208181|E3|Reported Event|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
254039|NCT01208181|E2|Reported Event|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
254040|NCT01208181|E1|Reported Event|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
254041|NCT01207934|B4|Baseline|Total|Total of all reporting groups
254042|NCT01207934|B3|Baseline|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
254043|NCT01207934|B2|Baseline|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
254044|NCT01207934|B1|Baseline|Placebo|saline placebo for fourteen days
254045|NCT01207934|P3|Participant Flow|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
254046|NCT01207934|P2|Participant Flow|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
254047|NCT01207934|P1|Participant Flow|Placebo|saline placebo for fourteen days
254048|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
254049|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
254050|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
254051|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
254052|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
254053|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
254054|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
254055|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
254056|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
254057|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
254058|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
254059|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
254060|NCT01207934|E3|Reported Event|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
254061|NCT01207934|E2|Reported Event|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
254062|NCT01207934|E1|Reported Event|Placebo|saline placebo for fourteen days
254063|NCT01207765|B1|Baseline|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
254064|NCT01207765|P1|Participant Flow|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
254065|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
254066|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
254067|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
254068|NCT01207765|E1|Reported Event|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
254069|NCT01207687|B1|Baseline|Treatment (Bevacizumab)|People with NF2, not eligible for surgery with progressive vestibular schwannoma
254070|NCT01207687|P1|Participant Flow|Treatment (Bevacizumab) - All Participants|Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
254071|NCT01207687|O2|Outcome|Treatment (Bevacizumab) - Pediatric Participants|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
254072|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|All enrolled participants received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 12 months.
254073|NCT01207687|O2|Outcome|Treatment (Bevacizumab) - Pediatric Participants|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
254074|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|All enrolled participants received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 12 months.
254075|NCT01207687|O2|Outcome|Treatment (Bevacizumab) - Pediatric Participants|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
254076|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|All enrolled patients received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
254077|NCT01207687|O2|Outcome|Treatment (Bevacizumab) - Pediatric Participants Only|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
254101|NCT01207583|B2|Baseline|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
254078|NCT01207687|O1|Outcome|Treatment (Bevacizumab) - All Participants|Patients who met all eligibility criteria underwent baseline evaluation and then received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity. Hearing evaluation for word recognition score was evaluated every 12 weeks. Hearing response was defined as improvement beyond the 95% CI maintained across 2 timepoints.
254079|NCT01207687|E2|Reported Event|Treatment (Bevacizumab) - Pediatric Participants|All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
254080|NCT01207687|E1|Reported Event|Treatment (Bevacizumab) - All Participants|All enrolled participants received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 12 months.
254081|NCT01207648|B1|Baseline|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
254082|NCT01207648|P1|Participant Flow|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
254083|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
254084|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
254085|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
254086|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
254087|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
254088|NCT01207648|E1|Reported Event|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
254089|NCT01207596|B1|Baseline|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
254090|NCT01207596|P1|Participant Flow|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
254091|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
254092|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
254093|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
254094|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
254095|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
254096|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
254097|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
254098|NCT01207596|E1|Reported Event|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
254099|NCT01207583|B4|Baseline|Total|Total of all reporting groups
254100|NCT01207583|B3|Baseline|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
301973|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
254102|NCT01207583|B1|Baseline|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of PCV7 vaccine as standard care as per the SmPC.
254103|NCT01207583|P3|Participant Flow|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
254104|NCT01207583|P2|Participant Flow|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
254105|NCT01207583|P1|Participant Flow|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of 7-valent pneumococcal conjugate vaccine (PCV7) as standard care as per the Summary of Product Characteristics (SmPC).
254106|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
254107|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
254108|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
254109|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254110|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254111|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254112|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccines as standard care as per the SmPC.
254113|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
254114|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
254115|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
254116|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
254117|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
254118|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254119|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254120|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254121|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
254122|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
254123|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
254124|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
254125|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
254126|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
254127|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254128|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254129|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254130|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
254131|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
254132|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
254133|NCT01207583|E9|Reported Event|Dose 2 (Catch-up Cohort [12-23 Months])|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254134|NCT01207583|E8|Reported Event|Dose 1 (Catch-up Cohort [12-23 Months])|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
254135|NCT01207583|E7|Reported Event|Dose 3 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
254136|NCT01207583|E6|Reported Event|Dose 2 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254137|NCT01207583|E5|Reported Event|Dose 1 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
254138|NCT01207583|E4|Reported Event|Dose 4 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
254139|NCT01207583|E3|Reported Event|Dose 3 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
254140|NCT01207583|E2|Reported Event|Dose 2 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
254836|NCT01204736|E2|Reported Event|Group 2|Subjects with biceps-to-triceps tendon transfers
254141|NCT01207583|E1|Reported Event|Dose 1 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
254142|NCT01207570|B3|Baseline|Total|Total of all reporting groups
254143|NCT01207570|B2|Baseline|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
254144|NCT01207570|B1|Baseline|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
254145|NCT01207570|P2|Participant Flow|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
254146|NCT01207570|P1|Participant Flow|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
254147|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
254148|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
254149|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
254150|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
254151|NCT01207570|O2|Outcome|Passive Stretching|A single session of passive stretching
254152|NCT01207570|O1|Outcome|Endermotherapy|A single session of endermotherapy treatment
254153|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
254154|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
254155|NCT01207570|E2|Reported Event|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
254156|NCT01207570|E1|Reported Event|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
254157|NCT01207492|B1|Baseline|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously
nilotinib: Taken orally twice daily"
254158|NCT01207492|P1|Participant Flow|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously
nilotinib: Taken orally twice daily"
254159|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously
nilotinib: Taken orally twice daily"
254160|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously
nilotinib: Taken orally twice daily"
254161|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously
nilotinib: Taken orally twice daily"
254162|NCT01207492|E1|Reported Event|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously
nilotinib: Taken orally twice daily"
254163|NCT01207466|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
254164|NCT01207466|P2|Participant Flow|Nelfilcon A Comm'l / nelfilconA Invest'l|Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
254165|NCT01207466|P1|Participant Flow|Nelfilcon A Invest'l / nelfilconA Comm'l|Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
254166|NCT01207466|O2|Outcome|Nelfilcon A Commercial|Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
254167|NCT01207466|O1|Outcome|Nelfilcon A Investigational|Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
254168|NCT01207466|E2|Reported Event|Nelfilcon A Commercial|Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
254169|NCT01207466|E1|Reported Event|Nelfilcon A Investigational|Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
254170|NCT01207453|B3|Baseline|Total|Total of all reporting groups
254171|NCT01207453|B2|Baseline|Placebo and Then Milnacipran|Participants first received 6 weeks of placebo. This was followed by a 3-week wash-out. After the wash-out period, participants then received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily).
254172|NCT01207453|B1|Baseline|Milnacipran and Then Placebo|Participants first received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily). This was followed by a 3-week wash-out. Participants then received 6 weeks of placebo.
254173|NCT01207453|P2|Participant Flow|Placebo and Then Milnacipran|Participants first received 6 weeks of placebo. This was followed by a 3-week wash-out. After the wash-out period, participants then received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily).
254174|NCT01207453|P1|Participant Flow|Milnacipran and Then Placebo|Participants first received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily). This was followed by a 3-week wash-out. Participants then received 6 weeks of placebo.
254175|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.
Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
254176|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
254177|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.
Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
254178|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
254179|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.
Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
254180|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
254181|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.
Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
254182|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
254183|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.
Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
254184|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
254185|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.
Milnacipran: Participants who take Milnacipran twice a day orally dosage was titrated up to target dosage of 50 mg (12.5 mg, 25 mg and 50 mg)."
254186|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
254187|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.
Milnacipran is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
254188|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
254189|NCT01207453|E3|Reported Event|Washout Period|This 3-week period occurred after the first 6 weeks (when participants either received milnacipran or placebo). During the washout period, participants down titrated from the full dosage of milnacipran/placebo to nothing.
254190|NCT01207453|E2|Reported Event|Placebo|Participants received placebo tablets for 6 weeks. The tablets were identical in appearance to the milnacipran tablets.
254191|NCT01207453|E1|Reported Event|Milnacipran|Participants received milnacipran for 6 weeks. The dose was titrated according to the following schedule: 1) Days 1-3: milnacipran 12.5 mg twice daily, 2) Days 4-6: milnacipran 25 mg twice daily, 3) Days 7-42: milnacipran 50 mg twice daily. If participants could not tolerate the full dose, the dose was decreased to the highest tolerated dose.
254192|NCT01207427|B4|Baseline|Total|Total of all reporting groups
254193|NCT01207427|B3|Baseline|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
254194|NCT01207427|B2|Baseline|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
254195|NCT01207427|B1|Baseline|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1 mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
254196|NCT01207427|P3|Participant Flow|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
254197|NCT01207427|P2|Participant Flow|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
254198|NCT01207427|P1|Participant Flow|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-milligrams (mg) ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
254199|NCT01207427|O3|Outcome|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
254200|NCT01207427|O2|Outcome|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
254201|NCT01207427|O1|Outcome|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
254202|NCT01207427|E3|Reported Event|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
254203|NCT01207427|E2|Reported Event|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
254204|NCT01207427|E1|Reported Event|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1- mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
254205|NCT01207414|B3|Baseline|Total|Total of all reporting groups
254206|NCT01207414|B2|Baseline|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254260|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
254261|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
254207|NCT01207414|B1|Baseline|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254208|NCT01207414|P2|Participant Flow|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254209|NCT01207414|P1|Participant Flow|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254210|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254211|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254212|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254213|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254214|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254215|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254216|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254217|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254218|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254219|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254220|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254262|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
254263|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
301974|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
254221|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254222|NCT01207414|E2|Reported Event|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254223|NCT01207414|E1|Reported Event|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.
On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
254224|NCT01207401|B3|Baseline|Total|Total of all reporting groups
254225|NCT01207401|B2|Baseline|No Paracervical Block|
254226|NCT01207401|B1|Baseline|Paracervical Block|
254227|NCT01207401|P2|Participant Flow|No Paracervical Block|IUD insertion with no lidocaine injection
254228|NCT01207401|P1|Participant Flow|Paracervical Block|IUD insertion after a 10 cc 1% Lidocaine administeration at 4 o'clock and 8 o'clock at the cervical-vaginal mucosa.
254229|NCT01207401|O2|Outcome|No Paracervical Block|
254230|NCT01207401|O1|Outcome|Paracervical Block|
254231|NCT01207401|E2|Reported Event|No Paracervical Block|
254232|NCT01207401|E1|Reported Event|Paracervical Block|
254233|NCT01207388|B1|Baseline|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
254234|NCT01207388|P1|Participant Flow|Blinatumomab|"Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
Participants suitable for allogeneic hematopoietic stem cell transplant (HSCT) after treatment with at least 1 cycle of blinatumomab may have undergone allogeneic HSCT instead of receiving further cycles with blinatumomab."
254235|NCT01207388|O2|Outcome|Change From Baseline at End of Core Study|
254236|NCT01207388|O1|Outcome|Maximum Change From Baseline in Cycles 1 - 4|
254237|NCT01207388|O2|Outcome|Change From Baseline at End of Core Study|
254238|NCT01207388|O1|Outcome|Maximum Change From Baseline in Cycles 1 - 4|
254239|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
254240|NCT01207388|O6|Outcome|Cycle 1 MRD Unknown|Participants with an unknown MRD level at the end of cycle 1.
254241|NCT01207388|O5|Outcome|Cycle 1 MRD 10^-1|Participants with an MRD level 10^-1 at the end of cycle 1.
254242|NCT01207388|O4|Outcome|Cycle 1 MRD 10^-2|Participants with an MRD level 10^-2 at the end of cycle 1.
254243|NCT01207388|O3|Outcome|Cycle 1 MRD 10^-3|Participants with an MRD level 10^-3 at the end of cycle 1.
254244|NCT01207388|O2|Outcome|Cycle 1 MRD 10^-4|Participants with an MRD level 10^-4 at the end of cycle 1.
254245|NCT01207388|O1|Outcome|Cycle 1 MRD 10^-5|Participants with an MRD level 10^-5 at the end of cycle 1.
254246|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
254247|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
254248|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
254249|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
254250|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
254251|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
254252|NCT01207388|E1|Reported Event|Blinatumomab 15 µg/m2/d|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
254253|NCT01207219|B4|Baseline|Total|Total of all reporting groups
254254|NCT01207219|B3|Baseline|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
254255|NCT01207219|B2|Baseline|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
254256|NCT01207219|B1|Baseline|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
254257|NCT01207219|P3|Participant Flow|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
254258|NCT01207219|P2|Participant Flow|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
254259|NCT01207219|P1|Participant Flow|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
254264|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
254265|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
254266|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
254267|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
254268|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
254269|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
254270|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
254271|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
254272|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
254273|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
254274|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
254275|NCT01207219|E3|Reported Event|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
254276|NCT01207219|E2|Reported Event|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
254277|NCT01207219|E1|Reported Event|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
254278|NCT01207102|B1|Baseline|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
254279|NCT01207102|P1|Participant Flow|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
254280|NCT01207102|O1|Outcome|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
254281|NCT01207102|O1|Outcome|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
254282|NCT01207102|E1|Reported Event|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
254283|NCT01205828|B1|Baseline|Temozolomide + ABT-888|"Temozolomide and ABT-888
temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days
Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months)."
254284|NCT01205828|P1|Participant Flow|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
254285|NCT01205828|O1|Outcome|Temozolomide and ABT-888 in HCC Patients|"Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days
Temozolomide: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days
ABT-888: ABT-888 40 mg BID PO Days 1-7 every 28 days"
254286|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
254287|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
254288|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
254289|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
254290|NCT01205828|E1|Reported Event|Temozolomide + ABT-888|"Temozolomide and ABT-888
temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days
Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months)."
254291|NCT01206777|B1|Baseline|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
254292|NCT01206777|P1|Participant Flow|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
254293|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
254294|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
254295|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
254296|NCT01206777|E1|Reported Event|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
254297|NCT01206738|B4|Baseline|Total|Total of all reporting groups
254298|NCT01206738|B3|Baseline|General Information|No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
254363|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254299|NCT01206738|B2|Baseline|Alternative Intervention|Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
254300|NCT01206738|B1|Baseline|Persuasive Communication|The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
254301|NCT01206738|P3|Participant Flow|General Information|"No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care).
Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
254302|NCT01206738|P2|Participant Flow|Alternative Intervention|"Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
254303|NCT01206738|P1|Participant Flow|Persuasive Communication|"The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
254304|NCT01206738|O2|Outcome|Post|GPs receiving a postal invitation
254305|NCT01206738|O1|Outcome|Email|GPs receiving an email invitation
254306|NCT01206738|O3|Outcome|General Information|"No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.
General intervention: No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing."
254307|NCT01206738|O2|Outcome|Alternative Intervention|"This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic
Action plan: This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic"
254308|NCT01206738|O1|Outcome|Persuasive Communication|"The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
Persuasive communication: The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics."
254309|NCT01206738|E3|Reported Event|General Information|No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
254310|NCT01206738|E2|Reported Event|Alternative Intervention|Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
254311|NCT01206738|E1|Reported Event|Persuasive Communication|The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
254312|NCT01206660|B3|Baseline|Total|Total of all reporting groups
254313|NCT01206660|B2|Baseline|Placebo|"Placebo administered to affected area twice a day for 28 days
placebo: Placebo administered to affected area twice a day for 28 days"
254314|NCT01206660|B1|Baseline|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
254315|NCT01206660|P2|Participant Flow|Placebo|"Placebo administered to affected area twice a day for 28 days
placebo: Placebo administered to affected area twice a day for 28 days"
254316|NCT01206660|P1|Participant Flow|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
254317|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days
placebo: Placebo administered to affected area twice a day for 28 days"
254318|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
254319|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days
placebo: Placebo administered to affected area twice a day for 28 days"
254320|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
254321|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days
placebo: Placebo administered to affected area twice a day for 28 days"
254364|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
254837|NCT01204736|E1|Reported Event|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
254322|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
254323|NCT01206660|E2|Reported Event|Placebo|"Placebo administered to affected area twice a day for 28 days
placebo: Placebo administered to affected area twice a day for 28 days"
254324|NCT01206660|E1|Reported Event|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
254325|NCT01206608|B3|Baseline|Total|Total of all reporting groups
254326|NCT01206608|B2|Baseline|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
254327|NCT01206608|B1|Baseline|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
254328|NCT01206608|P2|Participant Flow|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
254329|NCT01206608|P1|Participant Flow|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
254330|NCT01206608|O2|Outcome|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of study drug was administration via local infiltration.
254331|NCT01206608|O1|Outcome|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of study drug was administration via local infiltration.
254332|NCT01206608|E2|Reported Event|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
254333|NCT01206608|E1|Reported Event|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
254334|NCT01206595|B3|Baseline|Total|Total of all reporting groups
254335|NCT01206595|B2|Baseline|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
254336|NCT01206595|B1|Baseline|SKY0402|Low-dose, low-mid dose, and mid-dose
254337|NCT01206595|P2|Participant Flow|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
254338|NCT01206595|P1|Participant Flow|SKY0402|Low-dose, low-mid dose, and mid-dose
254339|NCT01206595|O4|Outcome|SKY0402 Mid Dose|A single dose of SKY0402 (mid dose) was administered intraoperatively by local infiltration.
254340|NCT01206595|O3|Outcome|SKY0402 Low-Mid Dose|A single dose of SKY0402 (low-mid dose) was administered intraoperatively by local infiltration.
254341|NCT01206595|O2|Outcome|SKY0402 Low Dose|A single dose of SKY0402 (low dose) was administered intraoperatively by local infiltration.
254342|NCT01206595|O1|Outcome|Bupivacaine HCl|A single dose of bupivacaine HCl 125 mg was administered intraoperatively by local infiltration.
254343|NCT01206595|E2|Reported Event|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
254344|NCT01206595|E1|Reported Event|SKY0402|Low-dose, low-mid dose, and mid-dose
254345|NCT01206582|B3|Baseline|Total|Total of all reporting groups
254346|NCT01206582|B2|Baseline|Albumin|10 iv infusions for 8 weeks
254347|NCT01206582|B1|Baseline|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254348|NCT01206582|P2|Participant Flow|Albumin|10 iv infusions for 8 weeks
254349|NCT01206582|P1|Participant Flow|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, Illinois (IL). Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254350|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
254351|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254352|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
254353|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254354|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
254355|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254356|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
254357|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254358|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
254359|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254360|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
254361|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254362|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
254838|NCT01204697|B3|Baseline|Total|Total of all reporting groups
254365|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254366|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
254367|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254368|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
254369|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254370|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
254371|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254372|NCT01206582|E2|Reported Event|Albumin|10 iv infusions for 8 weeks
254373|NCT01206582|E1|Reported Event|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
254374|NCT01206517|B7|Baseline|Total|Total of all reporting groups
254375|NCT01206517|B6|Baseline|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254376|NCT01206517|B5|Baseline|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254377|NCT01206517|B4|Baseline|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254378|NCT01206517|B3|Baseline|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
254379|NCT01206517|B2|Baseline|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
254380|NCT01206517|B1|Baseline|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
254381|NCT01206517|P6|Participant Flow|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254382|NCT01206517|P5|Participant Flow|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254383|NCT01206517|P4|Participant Flow|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254384|NCT01206517|P3|Participant Flow|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
254385|NCT01206517|P2|Participant Flow|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
254386|NCT01206517|P1|Participant Flow|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
254387|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254388|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254389|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254390|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
254391|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
254392|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
254393|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254394|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254395|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254396|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
254397|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
254398|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
254399|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254400|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254401|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254402|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
254403|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
254404|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
254405|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254406|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254407|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
254408|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
254409|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
254410|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
254411|NCT01206517|E3|Reported Event|Asenapine 10 mg - Cohort 3a-d|"Participants 10-17 years of age:
Participants 10 or 11 years of age (Cohort 3a); administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
Participants 12-17 years of age (Cohort 3b-d); administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8"
254412|NCT01206517|E2|Reported Event|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
254413|NCT01206517|E1|Reported Event|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
254414|NCT01206478|B3|Baseline|Total|Total of all reporting groups
254415|NCT01206478|B2|Baseline|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.
At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
254416|NCT01206478|B1|Baseline|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
254417|NCT01206478|P2|Participant Flow|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.
At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
254418|NCT01206478|P1|Participant Flow|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
254419|NCT01206478|O2|Outcome|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.
At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
254420|NCT01206478|O1|Outcome|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
254421|NCT01206478|O2|Outcome|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.
At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
254422|NCT01206478|O1|Outcome|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
254423|NCT01206478|E2|Reported Event|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.
At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
254424|NCT01206478|E1|Reported Event|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
254425|NCT01206452|B3|Baseline|Total|Total of all reporting groups
254426|NCT01206452|B2|Baseline|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254427|NCT01206452|B1|Baseline|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254428|NCT01206452|P2|Participant Flow|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254429|NCT01206452|P1|Participant Flow|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254430|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254431|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254432|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254433|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254434|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254435|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254436|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254437|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254438|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254439|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254440|NCT01206452|E2|Reported Event|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254561|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
254441|NCT01206452|E1|Reported Event|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation"
254442|NCT01206439|B1|Baseline|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.
nebivolol: nebivolol 5 or 10 mg oral, daily"
254443|NCT01206439|P1|Participant Flow|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.
nebivolol: nebivolol 5 or 10 mg oral, daily"
254444|NCT01206439|O1|Outcome|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.
nebivolol: nebivolol 5 or 10 mg oral, daily"
254445|NCT01206439|E1|Reported Event|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.
nebivolol: nebivolol 5 or 10 mg oral, daily"
254446|NCT01206387|B3|Baseline|Total|Total of all reporting groups
254447|NCT01206387|B2|Baseline|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
254448|NCT01206387|B1|Baseline|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
254449|NCT01206387|P2|Participant Flow|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
254450|NCT01206387|P1|Participant Flow|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
254451|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
254452|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
254453|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
254454|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
254455|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
254456|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
254457|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
254458|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
254459|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
254460|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
254461|NCT01206387|E2|Reported Event|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
254462|NCT01206387|E1|Reported Event|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
254463|NCT01206322|B3|Baseline|Total|Total of all reporting groups
254464|NCT01206322|B2|Baseline|Diabetics|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order."
254465|NCT01206322|B1|Baseline|Healthy|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order."
254466|NCT01206322|P4|Participant Flow|Control Group: Insulin First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
254467|NCT01206322|P3|Participant Flow|Control Group: Placebo First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
254468|NCT01206322|P2|Participant Flow|Diabetes Group: Insulin First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
254469|NCT01206322|P1|Participant Flow|Diabetes Group: Placebo First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
254470|NCT01206322|O4|Outcome|Control Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
254471|NCT01206322|O3|Outcome|Control Group: Placebo|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
254472|NCT01206322|O2|Outcome|Diabetes Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group.
254473|NCT01206322|O1|Outcome|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R))."
254474|NCT01206322|O4|Outcome|Control Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
254924|NCT01204658|B5|Baseline|Total|Total of all reporting groups
254475|NCT01206322|O3|Outcome|Control Group: Placebo|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
254476|NCT01206322|O2|Outcome|Diabetes Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group.
254477|NCT01206322|O1|Outcome|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R))."
254478|NCT01206322|E4|Reported Event|Control Group: Insulin|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.
The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
254479|NCT01206322|E3|Reported Event|Control Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.
The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
254480|NCT01206322|E2|Reported Event|Diabetes Group: Insulin|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.
The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
254481|NCT01206322|E1|Reported Event|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.
Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.
The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
254482|NCT01206140|B3|Baseline|Total|Total of all reporting groups
254483|NCT01206140|B2|Baseline|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
Temsirolimus: Given IV"
254484|NCT01206140|B1|Baseline|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
254485|NCT01206140|P2|Participant Flow|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
Temsirolimus: Given IV"
254486|NCT01206140|P1|Participant Flow|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
254487|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
Temsirolimus: Given IV"
254488|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
254489|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
Temsirolimus: Given IV"
254490|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
254491|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
Temsirolimus: Given IV"
254492|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
254493|NCT01206140|E2|Reported Event|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
Temsirolimus: Given IV"
254494|NCT01206140|E1|Reported Event|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
254495|NCT01206101|B3|Baseline|Total|Total of all reporting groups
254496|NCT01206101|B2|Baseline|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254497|NCT01206101|B1|Baseline|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254498|NCT01206101|P2|Participant Flow|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254499|NCT01206101|P1|Participant Flow|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254500|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254501|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254502|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254503|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254504|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254505|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254506|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254507|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254508|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254509|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254510|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254511|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254512|NCT01206101|E2|Reported Event|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254513|NCT01206101|E1|Reported Event|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
254514|NCT01205685|B1|Baseline|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
Erlotinib in a pill form, by mouth, once a day
Letrozole in a pill form, by mouth, once a day
Goserelin, by injection once per month for women who are pre-menopausal"
254515|NCT01205685|P1|Participant Flow|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
Erlotinib in a pill form, by mouth, once a day
Letrozole in a pill form, by mouth, once a day
Goserelin, by injection once per month for women who are pre-menopausal"
254516|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
Erlotinib in a pill form, by mouth, once a day
Letrozole in a pill form, by mouth, once a day
Goserelin, by injection once per month for women who are pre-menopausal"
254517|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
Erlotinib in a pill form, by mouth, once a day
Letrozole in a pill form, by mouth, once a day
Goserelin, by injection once per month for women who are pre-menopausal"
254518|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
Erlotinib in a pill form, by mouth, once a day
Letrozole in a pill form, by mouth, once a day
Goserelin, by injection once per month for women who are pre-menopausal"
254519|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
Erlotinib in a pill form, by mouth, once a day
Letrozole in a pill form, by mouth, once a day
Goserelin, by injection once per month for women who are pre-menopausal"
254520|NCT01205685|E1|Reported Event|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
Erlotinib in a pill form, by mouth, once a day
Letrozole in a pill form, by mouth, once a day
Goserelin, by injection once per month for women who are pre-menopausal"
254521|NCT01205646|B1|Baseline|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.
zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.
PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
254562|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
254522|NCT01205646|P1|Participant Flow|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.
zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.
PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
254523|NCT01205646|O1|Outcome|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.
zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.
PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
254524|NCT01205646|E1|Reported Event|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.
zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.
PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
254525|NCT01205581|B7|Baseline|Total|Total of all reporting groups
254526|NCT01205581|B6|Baseline|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
254527|NCT01205581|B5|Baseline|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
254528|NCT01205581|B4|Baseline|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
254529|NCT01205581|B3|Baseline|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
254530|NCT01205581|B2|Baseline|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
254531|NCT01205581|B1|Baseline|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
254532|NCT01205581|P6|Participant Flow|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
254533|NCT01205581|P5|Participant Flow|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
254534|NCT01205581|P4|Participant Flow|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
254535|NCT01205581|P3|Participant Flow|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
254536|NCT01205581|P2|Participant Flow|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
254537|NCT01205581|P1|Participant Flow|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
254538|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
254539|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
254540|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
254541|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
254542|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
254543|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
254544|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
254545|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
254546|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
254547|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
254548|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
254549|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
254550|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
254551|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
254552|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
254553|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
254554|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
254555|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
254556|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
254557|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
254558|NCT01205581|O2|Outcome|ALC ≥1000 Cells/mm³|Participants whose ALC was ≥1000 cells/mm³ were analyzed.
254559|NCT01205581|O1|Outcome|ALC <1000 Cells/mm³|Participants whose ALC was <1000 cells/mm³ were analyzed.
254560|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
254563|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
254564|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
254565|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
254566|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
254567|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
254568|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
254569|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
254570|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
254571|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
254572|NCT01205581|O2|Outcome|ALC ≥1000 Cells/mm³|Participants whose ALC was ≥1000 cells/mm³ were analyzed.
254573|NCT01205581|O1|Outcome|ALC <1000 Cells/mm³|Participants whose ALC was <1000 cells/mm³ were analyzed.
254574|NCT01205581|O6|Outcome|HIV-2 Doses|Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone SD.
254575|NCT01205581|O5|Outcome|HIV-1 Dose|Patients with a diagnosis of HIV who received one dose of high dose Fluzone SD.
254576|NCT01205581|O4|Outcome|Solid Tumor-2 Doses|Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone SD.
254577|NCT01205581|O3|Outcome|Solid Tumor-1 Dose|Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone SD.
254578|NCT01205581|O2|Outcome|Leukemia-2 Doses|Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone SD.
254579|NCT01205581|O1|Outcome|Leukemia-1 Dose|Patients with a diagnosis of leukemia who received one dose of high dose Fluzone SD.
254580|NCT01205581|O6|Outcome|HIV-2 Doses|Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone HD.
254581|NCT01205581|O5|Outcome|HIV-1 Dose|Patients with a diagnosis of HIV who received one dose of high dose Fluzone HD.
254582|NCT01205581|O4|Outcome|Solid Tumor-2 Doses|Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone HD.
254583|NCT01205581|O3|Outcome|Solid Tumor-1 Dose|Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone HD.
254584|NCT01205581|O2|Outcome|Leukemia-2 Doses|Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone HD.
254585|NCT01205581|O1|Outcome|Leukemia-1 Dose|Patients with a diagnosis of leukemia who received one dose of high dose Fluzone HD.
254586|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
254587|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
254588|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
254589|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
254590|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
254591|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
254592|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
254593|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
254594|NCT01205581|E6|Reported Event|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
254595|NCT01205581|E5|Reported Event|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
254596|NCT01205581|E4|Reported Event|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
254597|NCT01205581|E3|Reported Event|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
254598|NCT01205581|E2|Reported Event|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
254599|NCT01205581|E1|Reported Event|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
254600|NCT01205503|B3|Baseline|Total|Total of all reporting groups
254601|NCT01205503|B2|Baseline|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes"
254602|NCT01205503|B1|Baseline|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
254603|NCT01205503|P2|Participant Flow|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes"
254604|NCT01205503|P1|Participant Flow|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
254605|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
254692|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254606|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
254607|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
254608|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
254609|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
254610|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
254611|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
254612|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
254613|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
254614|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
254615|NCT01205503|E2|Reported Event|Saline|"Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during cycle assigned by randomization
Infused over 15 minutes"
254616|NCT01205503|E1|Reported Event|Mesna|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during cycle assigned by randomization
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
254617|NCT01205451|B3|Baseline|Total|Total of all reporting groups
254618|NCT01205451|B2|Baseline|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254619|NCT01205451|B1|Baseline|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254620|NCT01205451|P2|Participant Flow|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254621|NCT01205451|P1|Participant Flow|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254622|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254693|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254694|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
254623|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254624|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254625|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254626|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254627|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254628|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254629|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254630|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254631|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254632|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254633|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254634|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254635|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254636|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254637|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254638|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254695|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254696|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254697|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
254639|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254640|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254641|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254642|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254643|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254644|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254645|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254646|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254647|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254648|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254649|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254650|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254651|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254652|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254653|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254654|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254698|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254699|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254700|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
254655|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254656|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254657|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254658|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254659|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254660|NCT01205451|E2|Reported Event|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254661|NCT01205451|E1|Reported Event|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
254662|NCT01205399|B1|Baseline|AlloMax Surgical Graft Group|
254663|NCT01205399|P1|Participant Flow|AlloMax Surgical Graft Group|The study group included eligible subjects who underwent hernia repair using the AlloMax™ Surgical Graft at least 9 months prior to the start of this study.
254664|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
254665|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
254666|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
254667|NCT01205399|E1|Reported Event|AlloMax Surgical Graft Group|
254668|NCT01205269|B1|Baseline|Entire Study Population|Includes all groups randomized to one of 6 sequences of drug or placebo.
254669|NCT01205269|P6|Participant Flow|First Placebo, Then 50 mcg, Then 200 mcg|period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
254670|NCT01205269|P5|Participant Flow|First Placebo, Then 200 mcg, Then 50 mcg|period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
254671|NCT01205269|P4|Participant Flow|First 200 mcg, Then 50 mcg, Then Placebo|period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
254672|NCT01205269|P3|Participant Flow|First 200 mcg, Then Placebo, Then 50 mcg|period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
254673|NCT01205269|P2|Participant Flow|First 50 mcg, Then Placebo, Then 200 mcg|period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
254674|NCT01205269|P1|Participant Flow|First 50 mcg, Then 200 mcg, Then Placebo|period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: placebo
254675|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254676|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
254677|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254678|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254679|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
254680|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254681|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254682|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
254683|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254684|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254685|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
254686|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254687|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254688|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
254689|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254690|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254691|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
255086|NCT01204294|E1|Reported Event|Bigu+Lina|biguanide plus linagliptin
254701|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254702|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254703|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
254704|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254705|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254706|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
254707|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254708|NCT01205269|E3|Reported Event|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
254709|NCT01205269|E2|Reported Event|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
254710|NCT01205269|E1|Reported Event|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
254711|NCT01205230|B3|Baseline|Total|Total of all reporting groups
254712|NCT01205230|B2|Baseline|Pazopanib, Followed by Pazopanib + Esomeprazole|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1, followed by pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (approximately 3 hours after the evening meal) for 5 consecutive days during Period 2
254713|NCT01205230|B1|Baseline|Pazopanib, Followed by Pazopanib + Ketoconazole|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254714|NCT01205230|P2|Participant Flow|Pazopanib, Followed by Pazopanib + Esomeprazole|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1, followed by pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (approximately 3 hours after the evening meal) for 5 consecutive days during Period 2
254715|NCT01205230|P1|Participant Flow|Pazopanib, Followed by Pazopanib + Ketoconazole|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254716|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
254717|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
254718|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254719|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
254720|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
254721|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
254722|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254723|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
254724|NCT01205230|O1|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254725|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
254726|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
254727|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254728|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
254729|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
254730|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
254731|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254732|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
254733|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
254734|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
301975|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
254735|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254736|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
254737|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
254738|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
254739|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254740|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
254741|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
254742|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
254743|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254744|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
254745|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
254746|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
254747|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254748|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
254749|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
254750|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
254751|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254752|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
254753|NCT01205230|E4|Reported Event|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
254754|NCT01205230|E3|Reported Event|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
254755|NCT01205230|E2|Reported Event|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
254756|NCT01205230|E1|Reported Event|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
254757|NCT01205126|B3|Baseline|Total|Total of all reporting groups
254758|NCT01205126|B2|Baseline|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254759|NCT01205126|B1|Baseline|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254760|NCT01205126|P2|Participant Flow|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254761|NCT01205126|P1|Participant Flow|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254762|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254763|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254764|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254833|NCT01204736|O1|Outcome|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
254834|NCT01204736|E4|Reported Event|Group 4|Unimpaired control subjects
254835|NCT01204736|E3|Reported Event|Group 3|Subjects with cervical SCI who have not had tendon transfers
254765|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254766|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254767|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254768|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254769|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254770|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254771|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254772|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254773|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254774|NCT01205126|E2|Reported Event|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254775|NCT01205126|E1|Reported Event|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
254776|NCT01205035|B3|Baseline|Total|Total of all reporting groups
254777|NCT01205035|B2|Baseline|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.
ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
254778|NCT01205035|B1|Baseline|Observation|Observation; No treatment given
254779|NCT01205035|P2|Participant Flow|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.
ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
254780|NCT01205035|P1|Participant Flow|Observation|Observation; No treatment given
254781|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.
ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
254782|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
254783|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.
ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
254784|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
254785|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.
ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
254786|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
254787|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.
ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
254788|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
254789|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.
ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
254790|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
254791|NCT01205035|E2|Reported Event|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.
ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
254792|NCT01205035|E1|Reported Event|Observation|Observation; No treatment given
254793|NCT01204853|B1|Baseline|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
254794|NCT01204853|P1|Participant Flow|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
254795|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
254796|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
254797|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
254798|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
254799|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
254800|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
254801|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
254802|NCT01204853|E1|Reported Event|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
254803|NCT01204788|B3|Baseline|Total|Total of all reporting groups
254804|NCT01204788|B2|Baseline|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
254805|NCT01204788|B1|Baseline|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
254806|NCT01204788|P2|Participant Flow|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
254807|NCT01204788|P1|Participant Flow|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
254808|NCT01204788|O2|Outcome|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
254809|NCT01204788|O1|Outcome|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
254810|NCT01204788|E2|Reported Event|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
254811|NCT01204788|E1|Reported Event|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
254812|NCT01204775|B3|Baseline|Total|Total of all reporting groups
254813|NCT01204775|B2|Baseline|Placebo|Placebo matching saxagliptin
254814|NCT01204775|B1|Baseline|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
254815|NCT01204775|P2|Participant Flow|Placebo|Placebo matching saxagliptin
254816|NCT01204775|P1|Participant Flow|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
254817|NCT01204775|O2|Outcome|Placebo|Placebo matching saxagliptin
254818|NCT01204775|O1|Outcome|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
254819|NCT01204775|E2|Reported Event|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
254820|NCT01204775|E1|Reported Event|Placebo|Placebo matching saxagliptin
254821|NCT01204736|B5|Baseline|Total|Total of all reporting groups
254822|NCT01204736|B4|Baseline|Group 4|Unimpaired control subjects
254823|NCT01204736|B3|Baseline|Group 3|Subjects with cervical SCI who have not had tendon transfers
254824|NCT01204736|B2|Baseline|Group 2|Subjects with biceps-to-triceps tendon transfers
254825|NCT01204736|B1|Baseline|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
254826|NCT01204736|P4|Participant Flow|Group 4|Unimpaired control subjects
254827|NCT01204736|P3|Participant Flow|Group 3|Subjects with cervical SCI who have not had tendon transfers
254828|NCT01204736|P2|Participant Flow|Group 2|Subjects with biceps-to-triceps tendon transfers
254829|NCT01204736|P1|Participant Flow|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
254830|NCT01204736|O4|Outcome|Group 4|Unimpaired control subjects
254831|NCT01204736|O3|Outcome|Group 3|Subjects with cervical SCI who have not had tendon transfers
254832|NCT01204736|O2|Outcome|Group 2|Subjects with biceps-to-triceps tendon transfers
301976|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
254839|NCT01204697|B2|Baseline|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
254840|NCT01204697|B1|Baseline|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
254841|NCT01204697|P2|Participant Flow|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 milligram per square meter (mg/m^2) as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
254842|NCT01204697|P1|Participant Flow|Erlotinib|Participants received erlotinib (Tarceva) at a dose of 150 milligram per day (mg/day) orally as monotherapy, up to progressive disease (PD), death, or unacceptable toxicity.
254843|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
254844|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
254845|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
254846|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
254847|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
254848|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
254849|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
254850|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
254851|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
254852|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
254853|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
254854|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
254855|NCT01204697|E2|Reported Event|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
254856|NCT01204697|E1|Reported Event|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
254857|NCT01204671|B6|Baseline|Total|Total of all reporting groups
254858|NCT01204671|B5|Baseline|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254859|NCT01204671|B4|Baseline|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254860|NCT01204671|B3|Baseline|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254861|NCT01204671|B2|Baseline|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254862|NCT01204671|B1|Baseline|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254863|NCT01204671|P5|Participant Flow|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
255087|NCT01204255|B1|Baseline|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
254864|NCT01204671|P4|Participant Flow|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254865|NCT01204671|P3|Participant Flow|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254866|NCT01204671|P2|Participant Flow|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254867|NCT01204671|P1|Participant Flow|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254868|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254869|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254870|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254871|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254872|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254873|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254874|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254875|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254876|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254877|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
254878|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254879|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254880|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254881|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254882|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254883|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254884|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254885|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254886|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254887|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254888|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254889|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254890|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254891|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254892|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254893|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254894|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254895|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254896|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254897|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254898|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254899|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254900|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254901|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254902|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254903|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254904|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254905|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254906|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254907|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254908|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254909|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254910|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254911|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254912|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254913|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254914|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254915|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254916|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254917|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254918|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254919|NCT01204671|E5|Reported Event|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254920|NCT01204671|E4|Reported Event|Fluarix Group|Subjects received one dose of the 1 dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254921|NCT01204671|E3|Reported Event|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254922|NCT01204671|E2|Reported Event|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254923|NCT01204671|E1|Reported Event|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
254925|NCT01204658|B4|Baseline|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254926|NCT01204658|B3|Baseline|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254927|NCT01204658|B2|Baseline|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254928|NCT01204658|B1|Baseline|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254929|NCT01204658|P4|Participant Flow|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254930|NCT01204658|P3|Participant Flow|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254931|NCT01204658|P2|Participant Flow|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254932|NCT01204658|P1|Participant Flow|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254933|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254934|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254935|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254936|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254937|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254938|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254939|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254940|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254941|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254942|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254943|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255088|NCT01204255|P1|Participant Flow|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
255089|NCT01204255|O1|Outcome|Application of Lorazepam, Diphenhydramine, Haloperidol|Topical application of lorazepam, diphenhydramine, haloperidol
255090|NCT01204255|E1|Reported Event|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
255365|NCT01202591|P5|Participant Flow|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
254944|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254945|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254946|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254947|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254948|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254949|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254950|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254951|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254952|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255091|NCT01204203|B1|Baseline|Zoledronic Acid (Zometa)|Zometa (zoledronic acid) 4mg will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
255102|NCT01203956|E3|Reported Event||From data available it cannot be determined which mode the subject was using at the time of this event.
255103|NCT01203956|E2|Reported Event|Standard|CPAP device used without SmartFlex engaged, either in first or second two-week period.
254953|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254954|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254955|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254956|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254957|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254958|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254959|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254960|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254961|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254962|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254963|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254964|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254965|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254966|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254967|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254968|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254969|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254970|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254971|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255092|NCT01204203|P1|Participant Flow|Zoledronic Acid (Zometa)|"Zoledronic acid (Zometa) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
Zoledronic acid (Zometa) will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
255104|NCT01203956|E1|Reported Event|SmartFlex|CPAP device used with SmartFlex engaged, either in first or second two-week period.
254972|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254973|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254974|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254975|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254976|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254977|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254978|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254979|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254980|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255093|NCT01204203|O1|Outcome|Zometa|"Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
255105|NCT01203930|B3|Baseline|Total|Total of all reporting groups
255795|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
254981|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254982|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254983|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254984|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254985|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254986|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254987|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254988|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254989|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254990|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254991|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254992|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254993|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254994|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254995|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254996|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
254997|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
254998|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
254999|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255094|NCT01204203|O1|Outcome|Zometa|"Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
255192|NCT01203787|E1|Reported Event|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
255000|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255001|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
255002|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
255003|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255004|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255005|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
255006|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
255007|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255008|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255095|NCT01204203|O1|Outcome|Zometa|"Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
255193|NCT01203644|B3|Baseline|Total|Total of all reporting groups
255194|NCT01203644|B2|Baseline|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
255009|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
255010|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
255011|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255012|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255013|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
255014|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
255015|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255016|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255017|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
255018|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
255019|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255020|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255021|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
255022|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
255023|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255024|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255025|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
255026|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
255027|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255096|NCT01204203|E1|Reported Event|Zoledronic Acid (Zometa)|Zoledronic acid (Zometa) will be administered IV-4mg by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles.The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.This will continue until progression of disease and/or intolerable toxicity.
255097|NCT01203956|B1|Baseline|All Evaluable Subjects|All subjects completing both two-week periods of crossover study, with evaluable results for each period.
255796|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
255028|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255029|NCT01204658|O2|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
255030|NCT01204658|O1|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255031|NCT01204658|O2|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
255032|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255033|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
255034|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
255035|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255036|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255098|NCT01203956|P2|Participant Flow|Standard First, Then Smartflex|First two weeks without Smartflex engaged, second two weeks with Smartflex engaged
255099|NCT01203956|P1|Participant Flow|SmartFlex First, Then Standard|First two weeks with Smartflex engaged, second two weeks without Smartflex engaged
255100|NCT01203956|O2|Outcome|Standard|Used CPAP device without SmartFlex engaged, in either first or second two-week period.
255101|NCT01203956|O1|Outcome|SmartFlex|Used CPAP device with SmartFlex engaged, in either first or second two-week period.
255037|NCT01204658|E4|Reported Event|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
255038|NCT01204658|E3|Reported Event|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
255039|NCT01204658|E2|Reported Event|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255040|NCT01204658|E1|Reported Event|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
255041|NCT01204398|B1|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
255042|NCT01204398|P1|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
255043|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
255044|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
255045|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
255046|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
255047|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
255048|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
255049|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
255050|NCT01204398|E1|Reported Event|T80/A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily
255051|NCT01204294|B8|Baseline|Total|Total of all reporting groups
255052|NCT01204294|B7|Baseline|A-GI+Met|alpha-glucosidase inhibitor plus metformin
255053|NCT01204294|B6|Baseline|SU+Met|sulfonylurea plus metformin
255054|NCT01204294|B5|Baseline|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
255055|NCT01204294|B4|Baseline|SU+Lina|sulfonylurea plus linagliptin
255056|NCT01204294|B3|Baseline|Glit+Lina|glitazone plus linagliptin
255057|NCT01204294|B2|Baseline|Glin+Lina|glinide plus linagliptin
255058|NCT01204294|B1|Baseline|Bigu+Lina|biguanide plus linagliptin
255059|NCT01204294|P7|Participant Flow|A-GI+Met|alpha-glucosidase inhibitor plus metformin
255060|NCT01204294|P6|Participant Flow|SU+Met|sulfonylurea plus metformin
255061|NCT01204294|P5|Participant Flow|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
255062|NCT01204294|P4|Participant Flow|SU+Lina|sulfonylurea plus linagliptin
255063|NCT01204294|P3|Participant Flow|Glit+Lina|glitazone plus linagliptin
255064|NCT01204294|P2|Participant Flow|Glin+Lina|glinide plus linagliptin
255065|NCT01204294|P1|Participant Flow|Bigu+Lina|biguanide plus linagliptin
255066|NCT01204294|O7|Outcome|A-GI+Met|alpha-glucosidase inhibitor plus metformin
255067|NCT01204294|O6|Outcome|SU+Met|sulfonylurea plus metformin
255068|NCT01204294|O5|Outcome|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
255069|NCT01204294|O4|Outcome|SU+Lina|sulfonylurea plus linagliptin
255070|NCT01204294|O3|Outcome|Glit+Lina|glitazone plus linagliptin
255071|NCT01204294|O2|Outcome|Glin+Lina|glinide plus linagliptin
255072|NCT01204294|O1|Outcome|Bigu+Lina|biguanide plus linagliptin
255073|NCT01204294|O7|Outcome|A-GI+Met|alpha-glucosidase inhibitor plus metformin
255074|NCT01204294|O6|Outcome|SU+Met|sulfonylurea plus metformin
255075|NCT01204294|O5|Outcome|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
255076|NCT01204294|O4|Outcome|SU+Lina|sulfonylurea plus linagliptin
255077|NCT01204294|O3|Outcome|Glit+Lina|glitazone plus linagliptin
255078|NCT01204294|O2|Outcome|Glin+Lina|glinide plus linagliptin
255079|NCT01204294|O1|Outcome|Bigu+Lina|biguanide plus linagliptin
255080|NCT01204294|E7|Reported Event|A-GI+Met|alpha-glucosidase inhibitor plus metformin
255081|NCT01204294|E6|Reported Event|SU+Met|sulfonylurea plus metformin
255082|NCT01204294|E5|Reported Event|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
255083|NCT01204294|E4|Reported Event|SU+Lina|sulfonylurea plus linagliptin
255084|NCT01204294|E3|Reported Event|Glit+Lina|glitazone plus linagliptin
255085|NCT01204294|E2|Reported Event|Glin+Lina|glinide plus linagliptin
255106|NCT01203930|B2|Baseline|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255107|NCT01203930|B1|Baseline|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
255108|NCT01203930|P2|Participant Flow|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255109|NCT01203930|P1|Participant Flow|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
255110|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255111|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
255112|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255113|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
255114|NCT01203930|O1|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255115|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
255116|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255117|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
255118|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255119|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
255120|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255121|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
255122|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255123|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
255124|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255125|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
255126|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255127|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
255128|NCT01203930|E2|Reported Event|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
255129|NCT01203930|E1|Reported Event|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
255130|NCT01203917|B1|Baseline|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
255131|NCT01203917|P1|Participant Flow|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
255132|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
255133|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
255134|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
255797|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
255135|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
255136|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
255137|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
255138|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
255139|NCT01203917|E1|Reported Event|Gefitinib 250 mg|
255140|NCT01203878|B4|Baseline|Total|Total of all reporting groups
255141|NCT01203878|B3|Baseline|Non-Randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period,
255142|NCT01203878|B2|Baseline|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
255143|NCT01203878|B1|Baseline|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
255144|NCT01203878|P3|Participant Flow|Non-randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period
255145|NCT01203878|P2|Participant Flow|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
255146|NCT01203878|P1|Participant Flow|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
255147|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
255148|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
255149|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
255150|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
255151|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
255152|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
255153|NCT01203878|E3|Reported Event|Non-Randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period.
255154|NCT01203878|E2|Reported Event|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
255155|NCT01203878|E1|Reported Event|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
255156|NCT01203852|B1|Baseline|Metoprolol + Chlorthalidone|"This group was assigned to the following: Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their HBP average or OBP is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks. Then will washout from all study medication. After washout, participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks.
Metoprolol: Metoprolol 50 mg twice daily titrated to 100 mg twice daily
Chlorthalidone: Chlorthalidone 25 mg 4 times per week titrated to 25 mg daily
Note: due to discontinuation of the manufacture of chlorthalidone 15 mg, effective Jan 1, 2013; the starting dose of chlorthalidone will be 25 mg 4 times per week (Mon, Wed, Thur, Sat) with subsequent titration to 25 mg daily."
255157|NCT01203852|P1|Participant Flow|Metoprolol + Chlorthalidone|"This group was assigned the following:
(Metoprolol 8 weeks): Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their home blood pressure (HBP) average or office blood pressure (OBP) is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks.
(Washout 2 weeks): Then will washout from all study medication.
(Chlorthalidone 8 weeks): participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks."
255158|NCT01203852|O1|Outcome|Adverse Metabolic Effects|Change in glucose after treatment with study medications
255159|NCT01203852|O3|Outcome|Chlorthalidone Only|Study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
255160|NCT01203852|O2|Outcome|Metorprolol Only|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded.
301977|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
255161|NCT01203852|O1|Outcome|Metoprolol + Chlorthalidone|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient’s hypertension was re-established. After another set of identical baseline labs, study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
255162|NCT01203852|E1|Reported Event|All Study Participants|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient’s hypertension was re-established. The subjects were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
255163|NCT01203826|B3|Baseline|Total|Total of all reporting groups
255164|NCT01203826|B2|Baseline|3 mg/kg Asfotase Alfa|Dose group shown is as per patient's randomization in Study ENB-006-09
255165|NCT01203826|B1|Baseline|2 mg/kg Asfotase Alfa|Dose group shown is as per patient's randomization in Study ENB-006-09
255166|NCT01203826|P2|Participant Flow|3 mg/kg Asfotase Alfa|The starting dose of asfotase alfa was 3 mg/kg/week for all patients in Study ENB-008-10 and was subsequently increased per study-wide dose adjustment to a total dose of 6 mg/kg/week. Results are shown by the patient's dose group assignment from Study ENB-006-09.
255167|NCT01203826|P1|Participant Flow|2 mg/kg Asfotase Alfa|The starting dose of asfotase alfa was 3 mg/kg/week for all patients in Study ENB-008-10 and was subsequently increased per study-wide dose adjustment to a total dose of 6 mg/kg/week. Results are shown by the patient's dose group assignment from Study ENB-006-09.
255168|NCT01203826|O1|Outcome|Asfotase Alfa Combined|ITT population for Study ENB-008-10, which included all patients that received treatment with asfotase alfa.
255169|NCT01203826|E3|Reported Event|Combined Asfotase Alfa Group|All patients treated with asfotase alfa during Study ENB-008-10
255170|NCT01203826|E2|Reported Event|3 mg/kg Asfotase Alfa|Dose group shown is as per patient’s randomization in Study ENB-006-09.
255171|NCT01203826|E1|Reported Event|2 mg/kg Asfotase Alfa|Dose group shown is as per patient’s randomization in Study ENB-006-09.
255172|NCT01203787|B3|Baseline|Total|Total of all reporting groups
255173|NCT01203787|B2|Baseline|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13, 200 mg twice daily from Day 14-Day 20, 600 mg daily from Day 21-Day 27, 400 mg twice daily beginning Day 28 until end of treatment or Week 24
255174|NCT01203787|B1|Baseline|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
255175|NCT01203787|P2|Participant Flow|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
255176|NCT01203787|P1|Participant Flow|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
255177|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
255178|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
255179|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
255180|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
255181|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
255182|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
255183|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
255184|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
255185|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
255186|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
255187|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|"200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
Sorafenib Standard Dosing Regimen: Sorafenib 400 mg twice daily until wk 24 or end of treatment"
255188|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|"Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
Sorafenib Ramp-Up Regimen: 200 mg daily, Day 0-Day 13 200 mg twice daily, Day 14-Day 20 600 mg daily, Day 21-Day 27 400 mg twice daily, Day 28 until end of treatment400 mg twice daily"
255189|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
255190|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
255191|NCT01203787|E2|Reported Event|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
255362|NCT01202591|B2|Baseline|AZD4547 40mg bd Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
255195|NCT01203644|B1|Baseline|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
255196|NCT01203644|P2|Participant Flow|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
255197|NCT01203644|P1|Participant Flow|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
255198|NCT01203644|O5|Outcome|SKY0402 High Dose|Single administration of SKY0402 (high dose) in a 40-mL volume via local infiltration
255199|NCT01203644|O4|Outcome|SKY0402 High-mid Dose|Single administration of SKY0402 (high-mid dose) in a 40-mL volume via local infiltration
255200|NCT01203644|O3|Outcome|SKY0402 Low-mid Dose|Single administration of SKY0402 (low-mid dose) in a 40-mL volume via local infiltration
255201|NCT01203644|O2|Outcome|SKY0402 Low Dose|Single administration of SKY0402 (low dose) in a 40-mL volume via local infiltration
255202|NCT01203644|O1|Outcome|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. Single 100 mg administration of 0.25% solution (i.e., 0.5% diluted 1:1) in a 40-mL volume via local infiltration
255203|NCT01203644|E2|Reported Event|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
255204|NCT01203644|E1|Reported Event|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
255205|NCT01203319|B4|Baseline|Total|Total of all reporting groups
255206|NCT01203319|B3|Baseline|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255207|NCT01203319|B2|Baseline|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255208|NCT01203319|B1|Baseline|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255209|NCT01203319|P3|Participant Flow|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255210|NCT01203319|P2|Participant Flow|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255211|NCT01203319|P1|Participant Flow|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255212|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255213|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255214|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255215|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255216|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255217|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255218|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255219|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255220|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255221|NCT01203319|E3|Reported Event|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255222|NCT01203319|E2|Reported Event|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255223|NCT01203319|E1|Reported Event|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
255224|NCT01203098|B4|Baseline|Total|Total of all reporting groups
255225|NCT01203098|B3|Baseline|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
255226|NCT01203098|B2|Baseline|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
255227|NCT01203098|B1|Baseline|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
255228|NCT01203098|P3|Participant Flow|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
255229|NCT01203098|P2|Participant Flow|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
255230|NCT01203098|P1|Participant Flow|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
255231|NCT01203098|O3|Outcome|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
255232|NCT01203098|O2|Outcome|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
255233|NCT01203098|O1|Outcome|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
255234|NCT01203098|O3|Outcome|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
255235|NCT01203098|O2|Outcome|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
255236|NCT01203098|O1|Outcome|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
255237|NCT01203098|E3|Reported Event|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
255238|NCT01203098|E2|Reported Event|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
255239|NCT01203098|E1|Reported Event|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
255240|NCT01203072|B6|Baseline|Total|Total of all reporting groups
255241|NCT01203072|B5|Baseline|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
255242|NCT01203072|B4|Baseline|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
255243|NCT01203072|B3|Baseline|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
255244|NCT01203072|B2|Baseline|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
255245|NCT01203072|B1|Baseline|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
255246|NCT01203072|P5|Participant Flow|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
255247|NCT01203072|P4|Participant Flow|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
255248|NCT01203072|P3|Participant Flow|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
255249|NCT01203072|P2|Participant Flow|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
255250|NCT01203072|P1|Participant Flow|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
255251|NCT01203072|O5|Outcome|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
255252|NCT01203072|O4|Outcome|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
255253|NCT01203072|O3|Outcome|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
255254|NCT01203072|O2|Outcome|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
255255|NCT01203072|O1|Outcome|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
255256|NCT01203072|O5|Outcome|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
255257|NCT01203072|O4|Outcome|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
255258|NCT01203072|O3|Outcome|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
255259|NCT01203072|O2|Outcome|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
255260|NCT01203072|O1|Outcome|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
255261|NCT01203072|E5|Reported Event|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
255262|NCT01203072|E4|Reported Event|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
255263|NCT01203072|E3|Reported Event|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
255264|NCT01203072|E2|Reported Event|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
255265|NCT01203072|E1|Reported Event|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
255266|NCT01203046|B3|Baseline|Total|Total of all reporting groups
255267|NCT01203046|B2|Baseline|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.
Group B will be treated with placebo during the following four days."
255268|NCT01203046|B1|Baseline|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.
Group A will be treated with Ertapenem during the following four days."
255269|NCT01203046|P2|Participant Flow|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.
Group B will be treated with placebo during the following four days."
255270|NCT01203046|P1|Participant Flow|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.
Group A will be treated with Ertapenem during the following four days."
255271|NCT01203046|O2|Outcome|GROUP B - 3 DAYS THERAPY|Patients with 3 days therapy
255272|NCT01203046|O1|Outcome|GROUP A - 7 DAYS THERAPY|Patients with 7 days therapy
255273|NCT01203046|O2|Outcome|GROUP B - 3 DAYS THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.
Group B will be treated with placebo during the following four days."
255274|NCT01203046|O1|Outcome|GROUP A: 7 DAYS THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.
Group A will be treated with Ertapenem during the following four days."
255363|NCT01202591|B1|Baseline|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 bd continuous + 25 mg exemestane
255275|NCT01203046|E2|Reported Event|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.
Group B will be treated with placebo during the following four days."
255276|NCT01203046|E1|Reported Event|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.
Group A will be treated with Ertapenem during the following four days."
255277|NCT01202955|B3|Baseline|Total|Total of all reporting groups
255278|NCT01202955|B2|Baseline|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
255279|NCT01202955|B1|Baseline|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
255280|NCT01202955|P2|Participant Flow|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
255281|NCT01202955|P1|Participant Flow|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
255282|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
255283|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
255284|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
255285|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
255286|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
255287|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
255288|NCT01202955|E2|Reported Event|Placebo First, Then Tolcapone|"To maintain the study blind, both the active Tolcapone and placebo medication periods used an increased-titration dose. Below is the breakdown of the increase in dosing of the active Tolcapone:
Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
During the placebo period, all participants followed the above dosing schedule; however, the capsules contained no tolcapone."
255289|NCT01202955|E1|Reported Event|Tolcapone First, Then Placebo|"To maintain the study blind, both the active Tolcapone and placebo medication periods used an increased-titration dose. Below is the breakdown of the increase in dosing of the active Tolcapone:
Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
During the placebo period, all participants followed the above dosing schedule; however, the capsules contained no tolcapone."
255290|NCT01202903|B3|Baseline|Total|Total of all reporting groups
255291|NCT01202903|B2|Baseline|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255292|NCT01202903|B1|Baseline|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255293|NCT01202903|P2|Participant Flow|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255294|NCT01202903|P1|Participant Flow|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255295|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255296|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255297|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255298|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255299|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255300|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255301|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255302|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255303|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255304|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255305|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255306|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255307|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255308|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255309|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255310|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255311|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255312|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255313|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255314|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255315|NCT01202903|E2|Reported Event|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
255316|NCT01202903|E1|Reported Event|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
255317|NCT01202877|B4|Baseline|Total|Total of all reporting groups
255318|NCT01202877|B3|Baseline|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
255319|NCT01202877|B2|Baseline|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
255320|NCT01202877|B1|Baseline|Phase I: 5-azacytidine + PKC412 25 mg|5-azacytidine (AZA) 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
255321|NCT01202877|P3|Participant Flow|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
255322|NCT01202877|P2|Participant Flow|Phase I: 5-azacytidine + PKC412 50 mg|5-azacytidine 75 mg/m2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
255323|NCT01202877|P1|Participant Flow|Phase I: 5-azacytidine + PKC412 25 mg|5-azacytidine 75 mg/m2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
255364|NCT01202591|P6|Participant Flow|Part B: Placebo + Fulvestrant|80mg Placebo BD + 500 mg Fulvestrant
255324|NCT01202877|O1|Outcome|5-azacytidine + PKC412|"5-azacytidine 75 mg/m2/d subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 50 mg by mouth twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
5-azacytidine: Starting dose: 75 mg/m2/d subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle.
PKC412: Starting dose: 50 mg by mouth twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily)."
255325|NCT01202877|O3|Outcome|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and PKC412 Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
255326|NCT01202877|O2|Outcome|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
255327|NCT01202877|O1|Outcome|Phase I: 5-azacytidine + PKC412 25 mg|AZA 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
255328|NCT01202877|E3|Reported Event|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and PKC412 Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
255329|NCT01202877|E2|Reported Event|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
255330|NCT01202877|E1|Reported Event|Phase I: 5-azacytidine + PKC412 25 mg|AZA 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
255331|NCT01202747|B1|Baseline|LipiFlow Treatment|Treatment with LipiFlow device
255332|NCT01202747|P1|Participant Flow|LipiFlow Treatment|Treatment with LipiFlow device
255333|NCT01202747|O1|Outcome|LipiFlow Treatment|Treatment with LipiFlow device
255334|NCT01202747|E1|Reported Event|LipiFlow Treatment|Treatment with LipiFlow device
255335|NCT01202656|B3|Baseline|Total|Total of all reporting groups
255336|NCT01202656|B2|Baseline|Saline Then G-CSF|"Normal Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
then
G-CSF (Granulocyte colony stimulating factor)
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
255337|NCT01202656|B1|Baseline|G-CSF Then Saline|"G-CSF (Granulocyte colony stimulating factor)
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
then
Normal Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
255338|NCT01202656|P2|Participant Flow|Saline Then G-CSF|"Normal Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
255339|NCT01202656|P1|Participant Flow|G-CSF Then Saline|"G-CSF (Granulocyte colony stimulating factor)
G-CSF 300 units administered by trans-cervical infusion one time on day of human chorionic gonadotropin(hCG) trigger for Ovulation"
255340|NCT01202656|O2|Outcome|Saline|"Normal Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
255341|NCT01202656|O1|Outcome|G-CSF|"G-CSF (Granulocyte colony stimulating factor)
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
255342|NCT01202656|O2|Outcome|Saline|"Normal Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
255343|NCT01202656|O1|Outcome|G-CSF|"G-CSF (Granulocyte colony stimulating factor)
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
255344|NCT01202656|E2|Reported Event|Saline|"Normal Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
255345|NCT01202656|E1|Reported Event|G-CSF|"G-CSF (Granulocyte colony stimulating factor)
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
255346|NCT01202643|B3|Baseline|Total|Total of all reporting groups
255347|NCT01202643|B2|Baseline|Saline Then G-CSF|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
255348|NCT01202643|B1|Baseline|G-CSF Then Saline|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
255349|NCT01202643|P2|Participant Flow|Saline Then G-CSF|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
255350|NCT01202643|P1|Participant Flow|G-CSF Then Saline|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
255351|NCT01202643|O2|Outcome|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
255352|NCT01202643|O1|Outcome|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
255353|NCT01202643|O2|Outcome|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
255354|NCT01202643|O1|Outcome|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
255355|NCT01202643|E2|Reported Event|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
255356|NCT01202643|E1|Reported Event|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
255357|NCT01202591|B7|Baseline|Total|Total of all reporting groups
255358|NCT01202591|B6|Baseline|Part B: Placebo + Fulvestrant|80 mg Placebo BD + 500 mg Fulvestrant
255359|NCT01202591|B5|Baseline|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
255360|NCT01202591|B4|Baseline|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
255361|NCT01202591|B3|Baseline|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
255366|NCT01202591|P4|Participant Flow|AZD4547 80mg bd 2w/1w + Ex|80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
255367|NCT01202591|P3|Participant Flow|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
255368|NCT01202591|P2|Participant Flow|AZD4547 40mg Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
255369|NCT01202591|P1|Participant Flow|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 BD continuous + 25 mg exemestane
255370|NCT01202591|O6|Outcome|Part B: Placebo + Fulvestrant|80mg Placebo BD + 500 mg Fulvestrant
255371|NCT01202591|O5|Outcome|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
255372|NCT01202591|O4|Outcome|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
255373|NCT01202591|O3|Outcome|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
255374|NCT01202591|O2|Outcome|AZD4547 40mg Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
255375|NCT01202591|O1|Outcome|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 BD continuous + 25 mg exemestane
255376|NCT01202591|E6|Reported Event|Part B: Placebo + Fulvestrant|80 mg Placebo BD + 500 mg Fulvestrant
255377|NCT01202591|E5|Reported Event|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
255378|NCT01202591|E4|Reported Event|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
255379|NCT01202591|E3|Reported Event|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
255380|NCT01202591|E2|Reported Event|AZD4547 40mg bd Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
255381|NCT01202591|E1|Reported Event|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 bd continuous + 25 mg exemestane
255382|NCT01202578|B1|Baseline|Tympanostomy Tube Placement Using the Tube Delivery System|
255383|NCT01202578|P1|Participant Flow|Tympanostomy Tube Placement Using the Tube Delivery System|
255384|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
255385|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
255386|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
255387|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
255388|NCT01202578|E1|Reported Event|Safety Events|Safety in terms of number affected subjects in total number of subjects.
255389|NCT01202565|B1|Baseline|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255390|NCT01202565|P1|Participant Flow|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255391|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255392|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255393|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255394|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255395|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255396|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255397|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255398|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255399|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255400|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255401|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255402|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255403|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255404|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255405|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255406|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255407|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255408|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255798|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
255409|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255410|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255411|NCT01202565|E1|Reported Event|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
255412|NCT01202279|B3|Baseline|Total|Total of all reporting groups
255413|NCT01202279|B2|Baseline|Placebo|Placebo given bid with a full glass of water for 7 days
255414|NCT01202279|B1|Baseline|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
255415|NCT01202279|P2|Participant Flow|Placebo|Placebo given bid with a full glass of water for 7 days
255416|NCT01202279|P1|Participant Flow|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
255417|NCT01202279|O2|Outcome|Placebo|Placebo given bid with a full glass of water for 7 days
255418|NCT01202279|O1|Outcome|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
255419|NCT01202279|O2|Outcome|Placebo|Placebo given bid with a full glass of water for 7 days
255420|NCT01202279|O1|Outcome|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
255421|NCT01202279|E2|Reported Event|Placebo|Placebo given bid with a full glass of water for 7 days
255422|NCT01202279|E1|Reported Event|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
255423|NCT01202253|B1|Baseline|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
255424|NCT01202253|P1|Participant Flow|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
255425|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255426|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255427|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255428|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255429|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255430|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255431|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255432|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255433|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255434|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255435|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255436|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255437|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255438|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255439|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255440|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255441|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255442|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255443|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255444|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255445|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255446|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255447|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255448|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255449|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255450|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255451|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255452|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255453|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255454|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255455|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255456|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
255457|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
255458|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255459|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
255460|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
255461|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
255462|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255463|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255464|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
255465|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
255466|NCT01202253|E1|Reported Event|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
255467|NCT01202227|B1|Baseline|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255468|NCT01202227|P1|Participant Flow|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255469|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255470|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255505|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255799|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
255471|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255472|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255473|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255474|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255475|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255476|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255477|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255478|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255479|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255480|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255481|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255482|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255483|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
301978|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
255484|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255485|NCT01202227|E1|Reported Event|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
255486|NCT01202188|B6|Baseline|Total|Total of all reporting groups
255487|NCT01202188|B5|Baseline|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255488|NCT01202188|B4|Baseline|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255489|NCT01202188|B3|Baseline|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255490|NCT01202188|B2|Baseline|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255491|NCT01202188|B1|Baseline|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255492|NCT01202188|P5|Participant Flow|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255493|NCT01202188|P4|Participant Flow|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255494|NCT01202188|P3|Participant Flow|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255495|NCT01202188|P2|Participant Flow|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255496|NCT01202188|P1|Participant Flow|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255497|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255498|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255499|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255500|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255501|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255502|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255503|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255504|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255647|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
301979|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
255506|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255507|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255508|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255509|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255510|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255511|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255512|NCT01202188|O4|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255513|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255514|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255515|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255516|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255517|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255518|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255519|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255520|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255521|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255522|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255523|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255524|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255525|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255526|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255527|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255675|NCT01201915|O3|Outcome|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
255528|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255529|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255530|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255531|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255532|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255533|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255534|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255535|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255536|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255537|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255538|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255539|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255540|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255541|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255542|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255543|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255544|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255545|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255546|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255547|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255548|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255549|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255676|NCT01201915|O2|Outcome|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
301980|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
255550|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255551|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255552|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255553|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255554|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255555|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255556|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255557|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255558|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255559|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255560|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255561|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255562|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255563|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255564|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255565|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255566|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255567|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255568|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255569|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255570|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255571|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255677|NCT01201915|O1|Outcome|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
301981|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
255572|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255573|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255574|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255575|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255576|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255577|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255578|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255579|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255580|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255581|NCT01202188|O2|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via the manufacturer's proprietary device for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255582|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255583|NCT01202188|O4|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255584|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255585|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255586|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255587|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255588|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255589|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255590|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255591|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255592|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255593|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255594|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255595|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
255596|NCT01202188|E5|Reported Event|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255597|NCT01202188|E4|Reported Event|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255598|NCT01202188|E3|Reported Event|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255599|NCT01202188|E2|Reported Event|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255600|NCT01202188|E1|Reported Event|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
255601|NCT01202162|B3|Baseline|Total|Total of all reporting groups
255602|NCT01202162|B2|Baseline|Sevoflurane|Administration of Sevoflurane
255603|NCT01202162|B1|Baseline|Desflurane|Administration of Desflurane
255604|NCT01202162|P2|Participant Flow|Sevoflurane|Administration of Sevoflurane
255605|NCT01202162|P1|Participant Flow|Desflurane|Administration of Desflurane
255606|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
255607|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
255608|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
255609|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
255610|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
255611|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
255612|NCT01202162|E2|Reported Event|Sevoflurane|Administration of Sevoflurane
255613|NCT01202162|E1|Reported Event|Desflurane|Administration of Desflurane
255614|NCT01202110|B1|Baseline|Control|Control
255615|NCT01202110|P2|Participant Flow|Propranolol|Propranolol
255616|NCT01202110|P1|Participant Flow|Control|Control
255617|NCT01202110|O1|Outcome|Propranolol|0
255618|NCT01202110|E1|Reported Event|Control|10
255619|NCT01202071|B1|Baseline|Entire Study Population: Group A, Group B, Group C, Group D|"Includes Group A, Group B, Group C, and Group D. Participants received Rabeprazole sodium Tablets for 5 days in each period.
Group A Period I: 5 mg, Period II: 10 mg, Period III: 20 mg, Period IV: 40 mg
Group B Period I: 10 mg, Period II: 20 mg, Period III: 40 mg, Period IV: 5 mg
Group C Period I: 20 mg, Period II: 40 mg, Period III: 5 mg, Period IV: 10 mg
Group D Period I: 40 mg, Period II: 5 mg, Period III: 10 mg, Period IV: 20 mg
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV, a washout period consisted of 6 days or longer between each period."
255620|NCT01202071|P4|Participant Flow|Group D: Rapeprazole 40 mg, Then 5 mg, Then 10 mg, Then 20 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Period I (9 days total): 40 mg; Period II (8 days total): 5 mg; Period III (8 days total): 10 mg; Period IV (8 days total): 20 mg
Each Period was separated by a >= 6 day washout period.
Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
255621|NCT01202071|P3|Participant Flow|Group C: Rapeprazole 20 mg, Then 40 mg, Then 5 mg, Then 10 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Period I (9 days total): 20 mg; Period II (8 days total): 40 mg; Period III (8 days total): 5 mg; Period IV (8 days total): 10 mg
Each Period was separated by a >= 6 day washout period.
Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
255622|NCT01202071|P2|Participant Flow|Group B: Rapeprazole 10 mg, Then 20 mg, Then 40 mg, Then 5 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Period I (9 days total): 10 mg; Period II (8 days total): 20 mg; Period III (8 days total): 40 mg; Period IV (8 days total): 5 mg
Each Period was separated by a >= 6 day washout period.
Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
255623|NCT01202071|P1|Participant Flow|Group A: Rapeprazole 5 mg, Then 10 mg, Then 20 mg, Then 40 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Period I (9 days total): 5 mg; Period II (8 days total): 10 mg; Period III (8 days total): 20 mg; Period IV (8 days total): 40 mg
Each Period was separated by a >= 6 day washout period.
Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
255624|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 40 mg was received by:
Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
255625|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 20 mg was received by:
Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
255792|NCT01201317|P1|Participant Flow|AZD2423 150 mg|tablets, 150 mg once daily in the morning
255626|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 10 mg was received by:
Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
255627|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 5 mg was received by:
Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
255628|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 40 mg was received by:
Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
255629|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 20 mg was received by:
Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
255630|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 10 mg was received by:
Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
255631|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 5 mg was received by:
Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
255632|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 40 mg was received by:
Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
255633|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 20 mg was received by:
Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
255634|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 10 mg was received by:
Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
255635|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 5 mg was received by:
Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
255636|NCT01202071|E4|Reported Event|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 40 mg was received by:
Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
255637|NCT01202071|E3|Reported Event|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 20 mg was received by:
Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
255638|NCT01202071|E2|Reported Event|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 10 mg was received by:
Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
255639|NCT01202071|E1|Reported Event|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 5 mg was received by:
Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
255640|NCT01201967|B3|Baseline|Total|Total of all reporting groups
255641|NCT01201967|B2|Baseline|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
255642|NCT01201967|B1|Baseline|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255643|NCT01201967|P2|Participant Flow|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
255644|NCT01201967|P1|Participant Flow|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255645|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
255646|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255648|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255649|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
255650|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255651|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
255652|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255653|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
255654|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255655|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
255656|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255657|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
255658|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255659|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
255660|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255661|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
255662|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255663|NCT01201967|E2|Reported Event|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
255664|NCT01201967|E1|Reported Event|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
255665|NCT01201915|B4|Baseline|Total|Total of all reporting groups
255666|NCT01201915|B3|Baseline|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
255667|NCT01201915|B2|Baseline|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
255668|NCT01201915|B1|Baseline|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
255669|NCT01201915|P3|Participant Flow|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
255670|NCT01201915|P2|Participant Flow|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
255671|NCT01201915|P1|Participant Flow|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
255672|NCT01201915|O3|Outcome|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
255673|NCT01201915|O2|Outcome|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
255674|NCT01201915|O1|Outcome|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
255678|NCT01201915|E3|Reported Event|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
255679|NCT01201915|E2|Reported Event|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
255680|NCT01201915|E1|Reported Event|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
255681|NCT01201811|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255682|NCT01201811|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255683|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255684|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255685|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255686|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255687|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255688|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255689|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255690|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255691|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255692|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255693|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255694|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255695|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255696|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255697|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255698|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255699|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255700|NCT01201811|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
255701|NCT01201798|B3|Baseline|Total|Total of all reporting groups
255702|NCT01201798|B2|Baseline|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255703|NCT01201798|B1|Baseline|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255704|NCT01201798|P2|Participant Flow|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255705|NCT01201798|P1|Participant Flow|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255706|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255707|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255708|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255709|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255710|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255711|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255712|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255713|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255714|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255715|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255716|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255717|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255718|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255719|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255720|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255721|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255793|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
255722|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255723|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255724|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255725|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255726|NCT01201798|E2|Reported Event|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
255727|NCT01201798|E1|Reported Event|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
255728|NCT01201785|B1|Baseline|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
255729|NCT01201785|P1|Participant Flow|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
255730|NCT01201785|O1|Outcome|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
255731|NCT01201785|E1|Reported Event|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
255732|NCT01201772|B4|Baseline|Total|Total of all reporting groups
255733|NCT01201772|B3|Baseline|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablets
255734|NCT01201772|B2|Baseline|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablets
255735|NCT01201772|B1|Baseline|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
255736|NCT01201772|P3|Participant Flow|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablet
255737|NCT01201772|P2|Participant Flow|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablet
255738|NCT01201772|P1|Participant Flow|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
255739|NCT01201772|O3|Outcome|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablets
255740|NCT01201772|O2|Outcome|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablets
255741|NCT01201772|O1|Outcome|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
255742|NCT01201772|E1|Reported Event|All Study Participants|All participants who received prasugrel
255743|NCT01201759|B3|Baseline|Total|Total of all reporting groups
255744|NCT01201759|B2|Baseline|Salsalate to Placebo 2gr BID|"Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.
Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2"
255745|NCT01201759|B1|Baseline|Placebo to Salsalate 2gr BID|"Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.
Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2."
255746|NCT01201759|P2|Participant Flow|Salsalate to Placebo 2gr BID|"Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.
Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2"
255747|NCT01201759|P1|Participant Flow|Placebo to Salsalate 2gr BID|"Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.
Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2."
255748|NCT01201759|O2|Outcome|Salsalate|Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
255749|NCT01201759|O1|Outcome|Placebo|Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
255750|NCT01201759|O2|Outcome|Salsalate|Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
255794|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
255751|NCT01201759|O1|Outcome|Placebo|Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
255752|NCT01201759|O2|Outcome|Salsalate|Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
255753|NCT01201759|O1|Outcome|Placebo|Placebo 2 grams twice a day for 30 days. Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
255754|NCT01201759|O2|Outcome|Salsalate|Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
255755|NCT01201759|O1|Outcome|Placebo|Placebo 2 grams twice a day for 30 days. Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
255756|NCT01201759|E2|Reported Event|Salsalate 2gr BID|Salsalate 2grams twice a day for 30 days.
255757|NCT01201759|E1|Reported Event|Placebo 2gr BID|Placebo twice a day for 30 days.
255758|NCT01201629|B3|Baseline|Total|Total of all reporting groups
255759|NCT01201629|B2|Baseline|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
255760|NCT01201629|B1|Baseline|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
255761|NCT01201629|P2|Participant Flow|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
255762|NCT01201629|P1|Participant Flow|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
255763|NCT01201629|O2|Outcome|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
255764|NCT01201629|O1|Outcome|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
255765|NCT01201629|O2|Outcome|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
255766|NCT01201629|O1|Outcome|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
255767|NCT01201629|O2|Outcome|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
255768|NCT01201629|O1|Outcome|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
255769|NCT01201629|E2|Reported Event|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
255770|NCT01201629|E1|Reported Event|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
255771|NCT01201486|B1|Baseline|Pregnant Women in Second Trimester|Pregnant females in the 2nd trimester.
255772|NCT01201486|P1|Participant Flow|Pregnant Women in Second Trimester|Pregnant females in the 2nd trimester.
255773|NCT01201486|O1|Outcome|Pregnant Women|Pregnant females in the 2nd trimester.
255774|NCT01201486|E1|Reported Event|Pregnant Women|Pregnant females in the 2nd trimester.
255775|NCT01201343|B1|Baseline|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
255776|NCT01201343|P1|Participant Flow|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
255777|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
255778|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
255779|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
255780|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
255781|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
255782|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
255783|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
255784|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
255785|NCT01201343|E1|Reported Event|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
255786|NCT01201317|B4|Baseline|Total|Total of all reporting groups
255787|NCT01201317|B3|Baseline|Placebo|tablets, once daily in the morning
255788|NCT01201317|B2|Baseline|AZD2423 20 mg|tablets, 20 mg once daily in the morning
255789|NCT01201317|B1|Baseline|AZD2423 150 mg|tablets, 150 mg once daily in the morning
255790|NCT01201317|P3|Participant Flow|Placebo|tablets, once daily in the morning
255791|NCT01201317|P2|Participant Flow|AZD2423 20 mg|tablets, 20 mg once daily in the morning
255800|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
255801|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
255802|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
255803|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
255804|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
255805|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
255806|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
255807|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
255808|NCT01201317|E3|Reported Event|Placebo|tablets, once daily in the morning
255809|NCT01201317|E2|Reported Event|AZD2423 20 mg|tablets, 20 mg once daily in the morning
255810|NCT01201317|E1|Reported Event|AZD2423 150 mg|tablets, 150 mg once daily in the morning
255811|NCT01201265|B1|Baseline|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255812|NCT01201265|P1|Participant Flow|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255813|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255814|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255815|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255816|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255817|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255818|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255819|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255820|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255821|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255822|NCT01201265|E1|Reported Event|All Particiapants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
255823|NCT01200992|B3|Baseline|Total|Total of all reporting groups
255824|NCT01200992|B2|Baseline|Mitomycin C|"40 mg mitomycin C mixed with water for injection to a total volume of 40 mL
Mitomycin C: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
255825|NCT01200992|B1|Baseline|EN3348|"8 mg EN3348 mixed with water for injection for a total volume of 50mL
EN3348: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
255826|NCT01200992|P2|Participant Flow|Mitomycin C|"40 mg mitomycin C mixed with water for injection to a total volume of 40 mL
Mitomycin C: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
255827|NCT01200992|P1|Participant Flow|EN3348|"8 mg EN3348 mixed with water for injection for a total volume of 50mL
EN3348: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
255828|NCT01200992|O2|Outcome|Mitomycin C|"40 mg mixed with sterile water for injection to a total volume of 40 mL
Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
255829|NCT01200992|O1|Outcome|EN3348|"8 mg mixed with sterile water for injection for a total volume of 50mL
Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
255830|NCT01200992|O2|Outcome|Mitomycin C|"40 mg mixed with water for injection to a total volume of 40 mL
Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)"
255831|NCT01200992|O1|Outcome|EN3348|"8 mg mixed with water for injection for a total volume of 50mL
Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)"
255832|NCT01200992|E2|Reported Event|Mitomycin C|"40 mg mixed with sterile water for injection to a total volume of 40 mL
Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
255833|NCT01200992|E1|Reported Event|EN3348|"8 mg mixed with sterile water for injection for a total volume of 50mL
Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
301982|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
255834|NCT01200875|B1|Baseline|Treatment Arm|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
255835|NCT01200875|P1|Participant Flow|PRP Injection (All Patients)|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
255836|NCT01200875|O1|Outcome|PRP Injection (All Patients)|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
255837|NCT01200875|E1|Reported Event|Treatment Arm|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
255838|NCT01200810|B3|Baseline|Total|Total of all reporting groups
255839|NCT01200810|B2|Baseline|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255840|NCT01200810|B1|Baseline|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255841|NCT01200810|P2|Participant Flow|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255842|NCT01200810|P1|Participant Flow|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255843|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255844|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255845|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255846|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255847|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255848|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255849|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255969|NCT01200511|P1|Participant Flow|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
255850|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255851|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255852|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255853|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255854|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255855|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255856|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255857|NCT01200810|E2|Reported Event|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255858|NCT01200810|E1|Reported Event|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally"
255859|NCT01200797|B1|Baseline|Treatment (SJG-136)|Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
255860|NCT01200797|P1|Participant Flow|Treatment (SJG-136)|SJG-136 was administered consecutively on days 1 - 3 as a 20-minute intravenous infusion, at a dose of 30 mcg/m2/day. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
255861|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
255862|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
255863|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
255864|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
255865|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
255866|NCT01200797|E1|Reported Event|Treatment (SJG-136)|Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
255867|NCT01200758|B3|Baseline|Total|Total of all reporting groups
255868|NCT01200758|B2|Baseline|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
301983|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
255869|NCT01200758|B1|Baseline|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255870|NCT01200758|P4|Participant Flow|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255871|NCT01200758|P3|Participant Flow|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255872|NCT01200758|P2|Participant Flow|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 milligrams [mg]; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255873|NCT01200758|P1|Participant Flow|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab intravenous (IV) infusion (375 milligrams per square meter [mg/m^2]; rituximab induction) in combination with up to 8 cycles of cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or cyclophosphamide, vincristine, prednisolone (CVP) chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least partial response (PR) during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255874|NCT01200758|O1|Outcome|All Participants|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP): First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP): Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255875|NCT01200758|O1|Outcome|All Participants|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP): First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP): Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255876|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255877|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255878|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255879|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255880|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255881|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255882|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255883|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255884|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
256815|NCT01197794|P3|Participant Flow|AZD1981 100 mg|AZD1981 100 mg twice daily
255885|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255886|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255887|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255888|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255889|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255890|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255891|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255892|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255893|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255894|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255895|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255896|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255897|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255898|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255899|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255900|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255901|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255902|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
256816|NCT01197794|P2|Participant Flow|AZD1981 200 mg|AZD1981 200 mg once daily
255903|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255904|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255905|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255906|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255907|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255908|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255909|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255910|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255911|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255912|NCT01200758|O2|Outcome|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255913|NCT01200758|O1|Outcome|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255914|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255915|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255916|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255917|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255918|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255919|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255920|NCT01200758|O2|Outcome|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
256817|NCT01197794|P1|Participant Flow|AZD1981 400 mg|AZD1981 400 mg twice daily
255921|NCT01200758|O1|Outcome|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255922|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255923|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255924|NCT01200758|E2|Reported Event|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
255925|NCT01200758|E1|Reported Event|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
255926|NCT01200602|B3|Baseline|Total|Total of all reporting groups
255927|NCT01200602|B2|Baseline|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
255928|NCT01200602|B1|Baseline|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
255929|NCT01200602|P2|Participant Flow|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
255930|NCT01200602|P1|Participant Flow|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
255931|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
255932|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
255933|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
255934|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
255935|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
255936|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
255937|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
255938|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
255939|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
255940|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
255941|NCT01200602|E2|Reported Event|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
255942|NCT01200602|E1|Reported Event|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
255943|NCT01200524|B4|Baseline|Total|Total of all reporting groups
255944|NCT01200524|B3|Baseline|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo"
255945|NCT01200524|B2|Baseline|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
255946|NCT01200524|B1|Baseline|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
255947|NCT01200524|P3|Participant Flow|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo"
255948|NCT01200524|P2|Participant Flow|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
255949|NCT01200524|P1|Participant Flow|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
255950|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo"
255951|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
255952|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
255953|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo"
255954|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
255955|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
255956|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo"
255957|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
255958|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
255959|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo"
255960|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
255961|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
255962|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo"
255963|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
255964|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
255965|NCT01200524|E3|Reported Event|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo"
255966|NCT01200524|E2|Reported Event|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
255967|NCT01200524|E1|Reported Event|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
255968|NCT01200511|B1|Baseline|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
256818|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
255970|NCT01200511|O2|Outcome|ReSTOR +3.0 Toric/With|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids if needed
255971|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric/Without|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
255972|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
255973|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
255974|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
255975|NCT01200511|E1|Reported Event|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
255976|NCT01200498|B1|Baseline|SB939|SB939 starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
255977|NCT01200498|P1|Participant Flow|SB939|SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
255978|NCT01200498|O1|Outcome|SB939|SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
255979|NCT01200498|E1|Reported Event|SB939|SB939 starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
255980|NCT01200433|B3|Baseline|Total|Total of all reporting groups
255981|NCT01200433|B2|Baseline|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.
dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
255982|NCT01200433|B1|Baseline|Propofol|"Subjects will be sedated with propofol.
propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
255983|NCT01200433|P2|Participant Flow|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.
dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
255984|NCT01200433|P1|Participant Flow|Propofol|"Subjects will be sedated with propofol.
propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
255985|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.
dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
255986|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.
propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
255987|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.
dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
255988|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.
propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
255989|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.
dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
255990|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.
propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
255991|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.
dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
255992|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.
propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
255993|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.
dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
255994|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.
propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
255995|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.
dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
255996|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.
propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
255997|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.
dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
255998|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.
propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
255999|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.
dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
256819|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
256000|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.
propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
256001|NCT01200433|E2|Reported Event|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.
dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
256002|NCT01200433|E1|Reported Event|Propofol|"Subjects will be sedated with propofol.
propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
256003|NCT01200368|B4|Baseline|Total|Total of all reporting groups
256004|NCT01200368|B3|Baseline|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256005|NCT01200368|B2|Baseline|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256006|NCT01200368|B1|Baseline|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256007|NCT01200368|P3|Participant Flow|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256008|NCT01200368|P2|Participant Flow|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256009|NCT01200368|P1|Participant Flow|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256010|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256011|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256012|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256013|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256014|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256015|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256095|NCT01200069|B2|Baseline|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
256016|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256017|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256018|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256019|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256020|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256021|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256022|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256023|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256024|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256025|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256026|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256027|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256028|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256029|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256175|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
301984|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
256030|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256031|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256032|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256033|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256034|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256035|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256036|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256037|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256038|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256039|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256040|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256041|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256042|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256043|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256176|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256044|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256045|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256046|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256047|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256048|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256049|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256050|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256051|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256052|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256053|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256054|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256055|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
256056|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256057|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256096|NCT01200069|B1|Baseline|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
256820|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
256058|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256059|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256060|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
256061|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
256062|NCT01200368|E10|Reported Event|DTaP (Catch-up 7vPnC) - After the Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
256063|NCT01200368|E9|Reported Event|DTaP (Catch-up 7vPnC) - Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
256064|NCT01200368|E8|Reported Event|7vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
256065|NCT01200368|E7|Reported Event|13vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 13vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
256066|NCT01200368|E6|Reported Event|DTaP (Catch-up 7vPnC) - After the Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
256067|NCT01200368|E5|Reported Event|7vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
256068|NCT01200368|E4|Reported Event|13vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
256069|NCT01200368|E3|Reported Event|DTaP (Catch-up 7vPnC) - Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
256070|NCT01200368|E2|Reported Event|7vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
256071|NCT01200368|E1|Reported Event|13vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
256072|NCT01200355|B3|Baseline|Total|Total of all reporting groups
256073|NCT01200355|B2|Baseline|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256074|NCT01200355|B1|Baseline|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256075|NCT01200355|P2|Participant Flow|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256076|NCT01200355|P1|Participant Flow|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256136|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #2|Subject reported myalgia 6 hours after completion of treatment #2
256077|NCT01200355|O2|Outcome|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256078|NCT01200355|O1|Outcome|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256079|NCT01200355|O2|Outcome|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256080|NCT01200355|O1|Outcome|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256081|NCT01200355|O2|Outcome|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256082|NCT01200355|O1|Outcome|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256083|NCT01200355|E2|Reported Event|Posaconazole|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256084|NCT01200355|E1|Reported Event|Micafungin|"This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy."
256085|NCT01200342|B1|Baseline|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
256086|NCT01200342|P1|Participant Flow|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
256087|NCT01200342|O1|Outcome|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
256088|NCT01200342|O1|Outcome|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
256089|NCT01200342|E1|Reported Event|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
256090|NCT01200160|B1|Baseline|Lipid Abnormalities|
256091|NCT01200160|P1|Participant Flow|Lipid Abnormalities|"No comparison groups for this observational study. Patients receive only one type of formulation, then drug exposure was the same for all patients.
This study was conducted in a prospective, single-arm, multi-center format. As this study was observational in nature, the follow-up of subject’s was not prescriptive in nature and was according to the judgment of the investigator, within the period of observation set forth in the protocol.
Typically, Niaspan is titrated in the following manner: After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Ideally, Niaspan should not be increased more than 500 mg in a 4-week period and daily doses above 2000 mg are not recommended. It is expected that women may respond at lower doses than men. However, consult with the approved label for titration recommendation in the particular country."
256092|NCT01200160|O1|Outcome|HDL-Cholesterol|
256093|NCT01200160|E1|Reported Event|Lipid Abnormalities|Those with the condition and exposed to the study drug
256094|NCT01200069|B3|Baseline|Total|Total of all reporting groups
256174|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
301985|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
256097|NCT01200069|P2|Participant Flow|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
256098|NCT01200069|P1|Participant Flow|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
256099|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 3|Subject reported headache 48 hours after completion of treatment #3
256100|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 3|Subject reported headache 48 hours after completion of treatment #3
256101|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #3|Subject reported headache 24 hours after completion of treatment #3
256102|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #3|Subject reported headache 24 hours after completion of treatment #3
256103|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #3|Subject reported headache 6 hours after completion of treatment #3
256104|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #3|Subject reported headache 6 hours after completion of treatment #3
256105|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #3|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 3 one hour after treatment
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
256106|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 3|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 3
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
256107|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment #2|Subject reported headache 48 hours after completion of treatment #2
256108|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment #2|Subject reported headache 48 hours after completion of treatment #2
256109|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #2|Subject reported headache 24 hours after completion of treatment #2
256110|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #2|Subject reported headache 24 hours after completion of treatment #2
256111|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #2|Subject reported headache 6 hours after completion of treatment #2
256112|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #2|Subject reported headache 6 hours after completion of treatment #2
256113|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #2|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments #2 one hour after treatment
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
256114|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 2|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 2
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
256115|NCT01200069|O8|Outcome|Pain Score Ibuprofen 48 Hours After Treatment 1|Subjects reported headache 48 hours after completion of treatment #1
256116|NCT01200069|O7|Outcome|Pain Score Sugar Water 48 Hours After Treatment 1|Subjects reported headache 48 hours after completion of treatment #1
256117|NCT01200069|O6|Outcome|Pain Score Ibuprofen 24 Hours After Treatment #1|Subjects reported headache 24 hours after completion of treatment #1
256118|NCT01200069|O5|Outcome|Pain Score Sugar Water 24 Hours After Treatment #1|Subject reported headache 24 hours after completion of treatment #1
256119|NCT01200069|O4|Outcome|Pain Score Ibuprofen 6 Hours After Treatment #1|Subject reported headache 6 hours after completion of treatment #1
256120|NCT01200069|O3|Outcome|Pain Score After Sugar Water 6 Hours After Treatment #1|Subject reported headache 6 hours after completion of treatment #1
256121|NCT01200069|O2|Outcome|Pain Score Ibuprofen One Hour After Treatment #1|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1 one hour after treatment
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
256122|NCT01200069|O1|Outcome|Pain Score Sugar Water-one Hour After Treatment 1|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 1"
256123|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 3|Subject reported myalgia 48 hours after completion of treatment #3
256124|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 3|Subject reported myalgia 48 hours after completion of treatment #3
256125|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #3|Subject reported myalgia 24 hours after completion of treatment #3
256126|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #3|Subject reported myalgia 24 hours after completion of treatment #3
256127|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #3|Subject reported myalgia 6 hours after completion of treatment #3
256128|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #3|Subject reported myalgia 6 hours after completion of treatment #3
256129|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #3|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 3 one hour after treatment
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
256130|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 3|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 3
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
256131|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 2|Subject reported myalgia 48 hours after completion of treatment #2
256132|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 2|Subject reported myalgia 48 hours after completion of treatment #2
256133|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #2|Subject reported myalgia 24 hours after completion of treatment #2
256134|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #2|Subject reported myalgia 24 hours after completion of treatment #2
256135|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #2|Subject reported myalgia 6 hours after completion of treatment #2
256137|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #2|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 2 one hour after treatment
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
256138|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 2|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 2
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
256139|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 1|subject reported myalgia 48 hours after treatment day 1
256140|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Procedure 1|subject reported myalgia 48 hours after procedure 1
256141|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment 1|subject reported myalgia 24 hours after procedure 1
256142|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #1|subject reported myalgia 24 hours after completion of procedure 1
256143|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #1|subject reported myalgia 6 hours after treatment 1
256144|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #1|Subject reported myalgia 6 hours after completion of treatment # 1,
256145|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #1|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
subject report of myalgia one hour after completion of procedure number 1"
256146|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment #1|500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure
256147|NCT01200069|E2|Reported Event|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3
ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
256148|NCT01200069|E1|Reported Event|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3
Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
256149|NCT01199965|B3|Baseline|Total|Total of all reporting groups
256150|NCT01199965|B2|Baseline|Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening.
256151|NCT01199965|B1|Baseline|Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result.
256152|NCT01199965|P2|Participant Flow|Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening.
256153|NCT01199965|P1|Participant Flow|Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result.
256154|NCT01199965|O4|Outcome|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at Visit 2 or 3.
256155|NCT01199965|O3|Outcome|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at Visit 2 or 3.
256156|NCT01199965|O2|Outcome|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at Visit 2 or 3.
256157|NCT01199965|O1|Outcome|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at Visit 2 or 3.
256158|NCT01199965|O4|Outcome|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3.
256159|NCT01199965|O3|Outcome|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3.
256160|NCT01199965|O2|Outcome|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3.
256161|NCT01199965|O1|Outcome|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at either Visit 2 or 3.
256162|NCT01199965|E4|Reported Event|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3.
256163|NCT01199965|E3|Reported Event|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3.
256164|NCT01199965|E2|Reported Event|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3.
256165|NCT01199965|E1|Reported Event|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at either Visit 2 or 3.
256166|NCT01199939|B1|Baseline|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256167|NCT01199939|P1|Participant Flow|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256168|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256169|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256170|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256171|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256172|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256173|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256177|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256178|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256179|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256180|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256181|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256182|NCT01199939|E1|Reported Event|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
256183|NCT01199926|B3|Baseline|Total|Total of all reporting groups
256184|NCT01199926|B2|Baseline|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
256185|NCT01199926|B1|Baseline|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
256186|NCT01199926|P2|Participant Flow|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
256187|NCT01199926|P1|Participant Flow|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
256188|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
256189|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
256190|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
256191|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
256192|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
256193|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
256194|NCT01199926|E2|Reported Event|Placebo|Were asked to consume a placebo pill (microcrystalline cellulose) each day for 3 months while performing a resistance training intervention.
256195|NCT01199926|E1|Reported Event|Vitamin D|Were asked to consume 4000 IU of vitamin D/day for 3 months while performing a resistance training intervention.
256196|NCT01199861|B3|Baseline|Total|Total of all reporting groups
256197|NCT01199861|B2|Baseline|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256198|NCT01199861|B1|Baseline|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256199|NCT01199861|P2|Participant Flow|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256200|NCT01199861|P1|Participant Flow|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256201|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256202|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256203|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256204|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256205|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256206|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256207|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256208|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256209|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256210|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256211|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256279|NCT01199705|O2|Outcome|SCIG IgPro20 Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.
256212|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256213|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256214|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256215|NCT01199861|E2|Reported Event|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256216|NCT01199861|E1|Reported Event|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
256217|NCT01199822|B4|Baseline|Total|Total of all reporting groups
256218|NCT01199822|B3|Baseline|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256219|NCT01199822|B2|Baseline|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256220|NCT01199822|B1|Baseline|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256221|NCT01199822|P3|Participant Flow|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256222|NCT01199822|P2|Participant Flow|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256223|NCT01199822|P1|Participant Flow|10 mg/kg Olaratumab (IMC-3G3)|10 milligrams/kilogram (mg/kg) olaratumab intravenously (IV) administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of progressive disease (PD), or until other withdrawal criteria were met.
256224|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256225|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256226|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256227|NCT01199822|O1|Outcome|Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met. 20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met. 15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256228|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
256229|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
256230|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
256231|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
256232|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
256233|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
256234|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
256235|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
256236|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
256237|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
256238|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
256239|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
256240|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
256241|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
256242|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
256243|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycle 1.
256244|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycle 1.
256245|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycle 1.
256246|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256247|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256248|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256249|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256250|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256251|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256252|NCT01199822|E3|Reported Event|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256253|NCT01199822|E2|Reported Event|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256254|NCT01199822|E1|Reported Event|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
256255|NCT01199744|B1|Baseline|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256256|NCT01199744|P1|Participant Flow|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256257|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256258|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256259|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256260|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256261|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256262|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256263|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256264|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256265|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256266|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256267|NCT01199744|E1|Reported Event|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
256268|NCT01199705|B1|Baseline|IgPro20|Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
256269|NCT01199705|P1|Participant Flow|IgPro20|Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
256270|NCT01199705|O2|Outcome|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
256271|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
256272|NCT01199705|O2|Outcome|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
256273|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
256274|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
256275|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
256276|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
256277|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
256278|NCT01199705|O3|Outcome|SCIG IgPro20 Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period.
256280|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
256281|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
256282|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
256283|NCT01199705|O3|Outcome|SCIG IgPro20 Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period.
256284|NCT01199705|O2|Outcome|SCIG IgPro20 Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.
256285|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
256286|NCT01199705|O3|Outcome|SCIG Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
256287|NCT01199705|O2|Outcome|SCIG Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
256288|NCT01199705|O1|Outcome|IVIG Treatment|Subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
256289|NCT01199705|O3|Outcome|SCIG Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
256290|NCT01199705|O2|Outcome|SCIG Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
256291|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
256292|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
256293|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
256294|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
256295|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
256296|NCT01199705|E2|Reported Event|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
256297|NCT01199705|E1|Reported Event|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).
256298|NCT01199601|B3|Baseline|Total|Total of all reporting groups
256299|NCT01199601|B2|Baseline|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention group).
Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
256300|NCT01199601|B1|Baseline|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers (control group) .
Intrapartum, postpartum counseling : Intrapartum testing and routine counseling."
256301|NCT01199601|P2|Participant Flow|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention)
Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
256302|NCT01199601|P1|Participant Flow|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers of same professional cadre as intervention group.
Intrapartum, postpartum counseling : Intrapartum testing and routine counseling package provided by study."
256303|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider
Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
256304|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.
Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
256305|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider
Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
256306|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.
Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
256307|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider
Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
256308|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.
Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
256395|NCT01198769|E1|Reported Event|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
256309|NCT01199601|E2|Reported Event|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider
Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
256310|NCT01199601|E1|Reported Event|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.
Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
256311|NCT01199471|B1|Baseline|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
256312|NCT01199471|P1|Participant Flow|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
256313|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
256314|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
256315|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
256316|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
256317|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
256318|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 through 3, who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).
256319|NCT01199471|E1|Reported Event|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
256320|NCT01199237|B3|Baseline|Total|Total of all reporting groups
256321|NCT01199237|B2|Baseline|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
256322|NCT01199237|B1|Baseline|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
256323|NCT01199237|P2|Participant Flow|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
256324|NCT01199237|P1|Participant Flow|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
256325|NCT01199237|O2|Outcome|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
256326|NCT01199237|O1|Outcome|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
256327|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
256328|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
256329|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
256330|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
256331|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
256332|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
256333|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
256334|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
256335|NCT01199237|E2|Reported Event|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
256336|NCT01199237|E1|Reported Event|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
256337|NCT01199042|B1|Baseline|Diagnostic, Then CPAP, Then BiPAP autoSV Advanced|Diagnostic, then CPAP, then BiPAP autoSV Advanced (within-subjects design)
256338|NCT01199042|P1|Participant Flow|Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV|All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device.
256339|NCT01199042|O1|Outcome|Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV|All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device.
256340|NCT01199042|O1|Outcome|BiPAP autoSV Advanced Device|"Positive airway pressure device
BiPAP autoSV Advanced: The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night."
256341|NCT01199042|O1|Outcome|BiPAP autoSV Advanced Device|Over the 90-day home treatment period, the Auto-Servo Ventilation (ASV) device consistently treated obstructive and central Sleep Disordered Breathing (SDB) events.
256342|NCT01199042|O3|Outcome|BiPAP autoSV Apnea-Hypopnea Index|The BiPAP autoSV machine was used to determine the Apnea-Hypopnea Index
256343|NCT01199042|O2|Outcome|Continuous Positive Airway Pressure Apnea-Hypopnea Index|The CPAP machine was used to determine the Apnea-Hypopnea Index.
256344|NCT01199042|O1|Outcome|Diagnostic Apnea-Hypopnea Index|Participants had Diagnostic PSG where the Apnea-Hypopnea Index was measured
256345|NCT01199042|E1|Reported Event|Diagnostic, Then CPAP, Then BiPAP autoSV Advanced|Participants had a diagnostic PSG, then CPAP and BiPAP autoSV. Participants then went home and used the autoSV for 90 days.
256346|NCT01199016|B1|Baseline|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
256347|NCT01199016|P1|Participant Flow|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
256348|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
256349|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
256350|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
256351|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
256352|NCT01199016|E1|Reported Event|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
256353|NCT01198977|B3|Baseline|Total|Total of all reporting groups
256354|NCT01198977|B2|Baseline|Education Counseling|"Exercise information and instructional video
Informational video: Mailed video of exercise programs"
256355|NCT01198977|B1|Baseline|Telephone Counseling|"Telephone based counseling and instructional video
Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
256356|NCT01198977|P2|Participant Flow|Education Counseling|"Exercise information and instructional video
Informational video: Mailed video of exercise programs"
256357|NCT01198977|P1|Participant Flow|Telephone Counseling|"Telephone based counseling and instructional video
Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
256358|NCT01198977|O2|Outcome|Education Counseling|"Exercise information and instructional video
Informational video: Mailed video of exercise programs"
256359|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video
Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
256360|NCT01198977|O2|Outcome|Education Counseling|"Exercise information and instructional video
Informational video: Mailed video of exercise programs"
256361|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video
Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
256362|NCT01198977|O2|Outcome|Education Counseling|"Self-directed physical activity information and instructional video
Informational video: Mailed video of Physical activity programs"
256363|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video
Intervention of brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
256364|NCT01198977|E2|Reported Event|Education Counseling|"Exercise information and instructional video (Control)
Informational video: Mailed video of exercise programs"
256365|NCT01198977|E1|Reported Event|Telephone Counseling|"Telephone based counseling and instructional video (Intervention)
Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
256366|NCT01198873|B3|Baseline|Total|Total of all reporting groups
256367|NCT01198873|B2|Baseline|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
256368|NCT01198873|B1|Baseline|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
256369|NCT01198873|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
256370|NCT01198873|P1|Participant Flow|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
256371|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
256372|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
256373|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
256374|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
256375|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
256376|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
256377|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
256378|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
256379|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
256380|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
256381|NCT01198873|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
256382|NCT01198873|E1|Reported Event|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
256383|NCT01198795|B1|Baseline|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
256384|NCT01198795|P1|Participant Flow|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
256385|NCT01198795|O1|Outcome|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
256386|NCT01198795|E1|Reported Event|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
256387|NCT01198769|B1|Baseline|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
256388|NCT01198769|P1|Participant Flow|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
256389|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
256390|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
256391|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
256392|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
256393|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
256394|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
256396|NCT01198756|B5|Baseline|Total|Total of all reporting groups
256397|NCT01198756|B4|Baseline|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256398|NCT01198756|B3|Baseline|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256399|NCT01198756|B2|Baseline|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256400|NCT01198756|B1|Baseline|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256401|NCT01198756|P4|Participant Flow|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256402|NCT01198756|P3|Participant Flow|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256403|NCT01198756|P2|Participant Flow|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256404|NCT01198756|P1|Participant Flow|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256405|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256406|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256407|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256408|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256409|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256410|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256411|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256412|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256413|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256414|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256415|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256416|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256417|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256821|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
256418|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256419|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256420|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256421|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256422|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256423|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256424|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256425|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256426|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256427|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256428|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256429|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256430|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256431|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256432|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256433|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256434|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256435|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256436|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256437|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256438|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256460|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256439|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256440|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256441|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256442|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256443|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256444|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256445|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256446|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256447|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256448|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256449|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256450|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256451|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256452|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256453|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256454|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256455|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256456|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256457|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256458|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256459|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256973|NCT01197534|B4|Baseline|Total|Total of all reporting groups
256461|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256462|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256463|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256464|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256465|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256466|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256467|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256468|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256469|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256470|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256471|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256472|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256473|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256474|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256475|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256476|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256477|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256478|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256479|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256480|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256481|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256482|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256483|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256484|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256485|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256486|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256487|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256488|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256489|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256490|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256491|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256492|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256493|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256494|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256495|NCT01198756|E4|Reported Event|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
256496|NCT01198756|E3|Reported Event|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256497|NCT01198756|E2|Reported Event|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256498|NCT01198756|E1|Reported Event|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
256499|NCT01198691|B3|Baseline|Total|Total of all reporting groups
256500|NCT01198691|B2|Baseline|Case Group|"This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
256501|NCT01198691|B1|Baseline|Control Group|"This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
256502|NCT01198691|P2|Participant Flow|Case Group|"This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
256503|NCT01198691|P1|Participant Flow|Control Group|"This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
256504|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
256505|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
256506|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
256507|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
256508|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
256509|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
256510|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
256511|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
256512|NCT01198691|E2|Reported Event|Case Group|"This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
256513|NCT01198691|E1|Reported Event|Control Group|"This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
256514|NCT01198600|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
256515|NCT01198600|P4|Participant Flow|Phase 3: Lotrafilcon B Replacement Replacement|Contact lenses worn for 43 days with replacement pair dispensed on Day 1 and Day 28.
256516|NCT01198600|P3|Participant Flow|Phase 2: Lotrafilcon B Replacement|Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
256517|NCT01198600|P2|Participant Flow|Phase 1: Habitual Replacement, Then Habitual no Replacement|Contact lenses per participant's habitual prescription worn for 30 days with a new pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement.
256518|NCT01198600|P1|Participant Flow|Phase 1: Habitual no Replacement, Then Habitual Replacement|Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a new pair dispensed at Day 28.
256519|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
256520|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
256521|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
256522|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
256523|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
256524|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
256525|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
256526|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
256527|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
256528|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
256529|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.of Phase 2."
256530|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
256717|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256531|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
256532|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
256533|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
256534|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
256535|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
256536|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15 during Phase 3. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
256537|NCT01198600|E2|Reported Event|Lotrafilcon B Contact Lens|Contact lens worn for 56 days with a replacement dispensed at Day 28 in Phase 2, followed by 43 days in Phase 3 with a replacement dispensed at Day 1 and Day 14.
256538|NCT01198600|E1|Reported Event|Habitual Contact Lens|Contact lens per participant's habitual prescription worn for two 30-day periods in Phase 1, with a replacement dispensed at Day 28 in either Period 1 or Period 2.
256539|NCT01198574|B5|Baseline|Total|Total of all reporting groups
256540|NCT01198574|B4|Baseline|Placebo Group|Placebo group received iron placebo containing 2.5 mg folic acid weekly
256541|NCT01198574|B3|Baseline|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly
256542|NCT01198574|B2|Baseline|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly
256543|NCT01198574|B1|Baseline|Iron Group|Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly
256544|NCT01198574|P4|Participant Flow|Placebo Group|Placebo group received 2.5 mg folic acid weekly
256545|NCT01198574|P3|Participant Flow|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid + 15,000 IU Vitamin A weekly
256546|NCT01198574|P2|Participant Flow|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Placebo iron containing 2.5 mg folic acid weekly
256547|NCT01198574|P1|Participant Flow|Iron Group|Iron group received 60 mg of elemental iron, 2.5 mg folic acid + Placebo Vitamin A weekly
256548|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
256549|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
256550|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
256551|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
256552|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
256553|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
256554|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
256555|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
256556|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
256557|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
256558|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
256559|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
256560|NCT01198574|E4|Reported Event|Placebo Group|Placebo group received iron placebo containing 2.5 mg folic acid weekly
256561|NCT01198574|E3|Reported Event|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly
256562|NCT01198574|E2|Reported Event|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly
256563|NCT01198574|E1|Reported Event|Iron Group|Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly
256564|NCT01198548|B1|Baseline|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies"
256565|NCT01198548|P1|Participant Flow|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies"
256673|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256566|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies"
256567|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies"
256568|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies"
256569|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies"
256570|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies"
256571|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies"
256572|NCT01198548|E1|Reported Event|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies"
256573|NCT01198509|B7|Baseline|Total|Total of all reporting groups
256574|NCT01198509|B6|Baseline|Healthy Volunteers|Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
256575|NCT01198509|B5|Baseline|Psoriatic Arthritis (PsA)|Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
256576|NCT01198509|B4|Baseline|Early RA Cross-sectional Cohort|Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).
256577|NCT01198509|B3|Baseline|Rheumatoid Arthritis (RA) Randomized to no Treatment|Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment and followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.
256578|NCT01198509|B2|Baseline|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks
vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
256579|NCT01198509|B1|Baseline|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.
doxycycline: doxycycline - 100 mg twice per day, for 2 months"
256580|NCT01198509|P6|Participant Flow|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
N=58 (actual)"
256581|NCT01198509|P5|Participant Flow|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
N=20 (actual)"
256582|NCT01198509|P4|Participant Flow|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).
N=66 (actual)"
256583|NCT01198509|P3|Participant Flow|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.
N=19 (actual)"
256584|NCT01198509|P2|Participant Flow|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks
vancomycin: vancomycin, 250 mg four times a day, for 2 weeks
N=10 (actual)"
256813|NCT01197794|P5|Participant Flow|AZD1981 40 mg|AZD1981 40 mg twice daily
256585|NCT01198509|P1|Participant Flow|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.
doxycycline: doxycycline - 100 mg twice per day, for 2 months
N=5 (actual)"
256586|NCT01198509|O6|Outcome|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
N=58 (actual)"
256587|NCT01198509|O5|Outcome|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
N=20 (actual)"
256588|NCT01198509|O4|Outcome|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).
N=66 (actual)"
256589|NCT01198509|O3|Outcome|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment and followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.
N=19 (actual)"
256590|NCT01198509|O2|Outcome|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks
vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
256591|NCT01198509|O1|Outcome|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.
doxycycline: doxycycline - 100 mg twice per day, for 2 months"
256592|NCT01198509|O6|Outcome|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
N=58 (actual)"
256593|NCT01198509|O5|Outcome|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
N=20 (actual)"
256594|NCT01198509|O4|Outcome|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).
N=66 (actual)"
256595|NCT01198509|O3|Outcome|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment, followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.
N=19 (actual)"
256596|NCT01198509|O2|Outcome|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks
vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
256597|NCT01198509|O1|Outcome|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.
doxycycline: doxycycline - 100 mg twice per day, for 2 months"
256598|NCT01198509|E3|Reported Event|RA, PsA, Healthy|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.
Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients."
256599|NCT01198509|E2|Reported Event|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks
vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
256600|NCT01198509|E1|Reported Event|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.
doxycycline: doxycycline - 100 mg twice per day, for 2 months"
256601|NCT01198366|B7|Baseline|Total|Total of all reporting groups
256602|NCT01198366|B6|Baseline|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer"
256603|NCT01198366|B5|Baseline|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256604|NCT01198366|B4|Baseline|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256605|NCT01198366|B3|Baseline|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256606|NCT01198366|B2|Baseline|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256607|NCT01198366|B1|Baseline|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer"
256608|NCT01198366|P6|Participant Flow|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer"
256609|NCT01198366|P5|Participant Flow|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256610|NCT01198366|P4|Participant Flow|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256674|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256611|NCT01198366|P3|Participant Flow|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256612|NCT01198366|P2|Participant Flow|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256613|NCT01198366|P1|Participant Flow|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer"
256614|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer"
256615|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256616|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256617|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256618|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256619|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer"
256620|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer"
256621|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256622|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256623|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256624|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256625|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer"
256626|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer"
256627|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256628|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256629|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256630|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256631|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer"
256632|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer"
256633|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256634|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256635|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
301986|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
256636|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256637|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer"
256638|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer"
256639|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256640|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256641|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256642|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
256643|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer"
256644|NCT01198366|E6|Reported Event|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo (sterile buffer) on days 0, 28 and 280.
Placebo"
256645|NCT01198366|E5|Reported Event|Expanded Safety Phase - Group 5|Subjects received 3 doses of AERAS-402 (1.0 X 10^11 vp) on days 0, 28 and 280.
256646|NCT01198366|E4|Reported Event|Dose Finding - Group 4|Subjects received two doses of AERAS-402 (1.0 x 10^11 vp) on study days 0 and 28.
256647|NCT01198366|E3|Reported Event|Dose Finding - Group 3|Subjects received two doses of AERAS-402 (3.0 x 10^10 vp) on study days 0 and 28.
256648|NCT01198366|E2|Reported Event|Dose Finding - Group 2|Subjects received two doses of AERAS-402 (1.5 x 10^10 vp) on study days 0 and 28.
256649|NCT01198366|E1|Reported Event|Dose Finding - Group 1|Subjects received two doses of placebo (sterile buffer) on study days 0 and 28.
256650|NCT01198327|B1|Baseline|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
256651|NCT01198327|P1|Participant Flow|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
256652|NCT01198327|O2|Outcome|Ranibizumab as Needed -BRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
256653|NCT01198327|O1|Outcome|Ranibizumab as Needed -CRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. CRVO stands for central retinal vein occlusion.
256654|NCT01198327|O2|Outcome|Ranibizumab as Needed -BRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
256655|NCT01198327|O1|Outcome|Ranibizumab as Needed -CRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. CRVO stands for Central retinal vein occlusion.
256656|NCT01198327|O1|Outcome|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
256657|NCT01198327|E1|Reported Event|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
256658|NCT01198275|B3|Baseline|Total|Total of all reporting groups
256659|NCT01198275|B2|Baseline|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
256660|NCT01198275|B1|Baseline|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
256661|NCT01198275|P2|Participant Flow|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
256662|NCT01198275|P1|Participant Flow|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
256663|NCT01198275|O2|Outcome|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
256664|NCT01198275|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
256665|NCT01198275|E2|Reported Event|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
256666|NCT01198275|E1|Reported Event|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
256667|NCT01198145|B3|Baseline|Total|Total of all reporting groups
256668|NCT01198145|B2|Baseline|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy. >
> placebo: Given orally"
256669|NCT01198145|B1|Baseline|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256670|NCT01198145|P2|Participant Flow|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
>
> placebo: Given orally"
256671|NCT01198145|P1|Participant Flow|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256672|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256814|NCT01197794|P4|Participant Flow|AZD1981 80 mg|AZD1981 80 mg once daily
256675|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256676|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256677|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256678|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256679|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256680|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256681|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256682|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256683|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256684|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256685|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256686|NCT01198145|O2|Outcome|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
>
> placebo: Given orally"
256687|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256688|NCT01198145|E2|Reported Event|Arm II: Placebo|placebo: Given orally
256689|NCT01198145|E1|Reported Event|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
256690|NCT01197911|B4|Baseline|Total|Total of all reporting groups
256691|NCT01197911|B3|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256692|NCT01197911|B2|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256693|NCT01197911|B1|Baseline|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256694|NCT01197911|P3|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256695|NCT01197911|P2|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256696|NCT01197911|P1|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256697|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256698|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256699|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256700|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256701|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256702|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256703|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256704|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256705|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256706|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256707|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256708|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256709|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256710|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256711|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256712|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256713|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256714|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256715|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256716|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256718|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256719|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256720|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256721|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256722|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256723|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256724|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256725|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256726|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256727|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256728|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256729|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256730|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256731|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256732|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256733|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256734|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256735|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256736|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256737|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256738|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256739|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256740|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256741|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256742|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256743|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256744|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256745|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256746|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256747|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256748|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256749|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256750|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256751|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256752|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256753|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256754|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256755|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256756|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256757|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256758|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256759|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256760|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256761|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256762|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256763|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256764|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256765|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256766|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256767|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256768|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 mcg tablet
256769|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256770|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256771|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256772|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256773|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256774|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256775|NCT01197911|E3|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256776|NCT01197911|E2|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
256777|NCT01197911|E1|Reported Event|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
256778|NCT01197898|B3|Baseline|Total|Total of all reporting groups
256779|NCT01197898|B2|Baseline|Vehicle Base|"Applied once daily
Placebo Comparator : Topical daily application"
256780|NCT01197898|B1|Baseline|Collagenase Santyl Ointment|"Applied once daily
Collagenase Santyl Ointment : Topical daily application"
256781|NCT01197898|P2|Participant Flow|Vehicle Base|"Applied once daily
Placebo Comparator : Topical daily application"
256782|NCT01197898|P1|Participant Flow|Collagenase Santyl Ointment|"Applied once daily
Collagenase Santyl Ointment : Topical daily application"
256783|NCT01197898|O2|Outcome|Vehicle Base|"Applied once daily
Placebo Comparator : Topical daily application"
256784|NCT01197898|O1|Outcome|Collagenase Santyl Ointment|"Applied once daily
Collagenase Santyl Ointment : Topical daily application"
256785|NCT01197898|E2|Reported Event|Vehicle Base|"Applied once daily
Placebo Comparator : Topical daily application"
256786|NCT01197898|E1|Reported Event|Collagenase Santyl Ointment|"Applied once daily
Collagenase Santyl Ointment : Topical daily application"
256787|NCT01197833|B4|Baseline|Total|Total of all reporting groups
256788|NCT01197833|B3|Baseline|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
256789|NCT01197833|B2|Baseline|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
256790|NCT01197833|B1|Baseline|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
256791|NCT01197833|P3|Participant Flow|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
256792|NCT01197833|P2|Participant Flow|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
256793|NCT01197833|P1|Participant Flow|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
256794|NCT01197833|O3|Outcome|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
256795|NCT01197833|O2|Outcome|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
256796|NCT01197833|O1|Outcome|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
256797|NCT01197833|O3|Outcome|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
256798|NCT01197833|O2|Outcome|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
256799|NCT01197833|O1|Outcome|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
256800|NCT01197833|E3|Reported Event|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
256801|NCT01197833|E2|Reported Event|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
256802|NCT01197833|E1|Reported Event|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
256803|NCT01197794|B8|Baseline|Total|Total of all reporting groups
256804|NCT01197794|B7|Baseline|Placebo|Placebo
256805|NCT01197794|B6|Baseline|AZD1981 10 mg|AZD1981 10 mg twice daily
256806|NCT01197794|B5|Baseline|AZD1981 40 mg|AZD1981 40 mg twice daily
256807|NCT01197794|B4|Baseline|AZD1981 80 mg|AZD1981 80 mg once daily
256808|NCT01197794|B3|Baseline|AZD1981 100 mg|AZD1981 100 mg twice daily
256809|NCT01197794|B2|Baseline|AZD1981 200 mg|AZD1981 200 mg once daily
256810|NCT01197794|B1|Baseline|AZD1981 400 mg|AZD1981 400 mg twice daily
256811|NCT01197794|P7|Participant Flow|Placebo|Placebo
256812|NCT01197794|P6|Participant Flow|AZD1981 10 mg|AZD1981 10 mg twice daily
256822|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
256823|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
256824|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
256825|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
256826|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
256827|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
256828|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
256829|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
256830|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
256831|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
256832|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
256833|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
256834|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
256835|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
256836|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
256837|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
256838|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
256839|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
256840|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
256841|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
256842|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
256843|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
256844|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
256845|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
256846|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
256847|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
256848|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
256849|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
256850|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
256851|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
256852|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
256853|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
256854|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
256855|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
256856|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
256857|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
256858|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
256859|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
256860|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
256861|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
256862|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
256863|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
256864|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
256865|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
256866|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
256867|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
256868|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
256869|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
256870|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
256871|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
256872|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
256873|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
256874|NCT01197794|O7|Outcome|Arm 7-Placebo|Placebo
256875|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
256876|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
256877|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
256878|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
256879|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
256880|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
256881|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
256882|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
256883|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
256884|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
256885|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
256886|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
256887|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
256888|NCT01197794|E7|Reported Event|Placebo|Placebo
256889|NCT01197794|E6|Reported Event|AZD1981 10 mg|AZD1981 10 mg twice daily
256890|NCT01197794|E5|Reported Event|AZD1981 40 mg|AZD1981 40 mg twice daily
256891|NCT01197794|E4|Reported Event|AZD1981 80 mg|AZD1981 80 mg once daily
256892|NCT01197794|E3|Reported Event|AZD1981 100 mg|AZD1981 100 mg twice daily
256893|NCT01197794|E2|Reported Event|AZD1981 200 mg|AZD1981 200 mg once daily
256894|NCT01197794|E1|Reported Event|AZD1981 400 mg|AZD1981 400 mg twice daily
256895|NCT01197755|B4|Baseline|Total|Total of all reporting groups
256896|NCT01197755|B3|Baseline|PLACEBO PO|Dosing Group C
256897|NCT01197755|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256898|NCT01197755|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
256899|NCT01197755|P3|Participant Flow|PLACEBO PO|Dosing Group C
301987|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
256900|NCT01197755|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256901|NCT01197755|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
256902|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
256903|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256904|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256905|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
256906|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256907|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256908|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
256909|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256910|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256911|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
256912|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256913|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256914|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
256915|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256916|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256917|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
256918|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256919|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256920|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
256921|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256922|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256923|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
256924|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256925|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256926|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
256927|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256928|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256929|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
256930|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256931|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256932|NCT01197755|O2|Outcome|Dosing Group A and B Combined PO|Fostamatinib 100 mg BID (combined)
256933|NCT01197755|O1|Outcome|PLACEBO PO|Dosing Group C
256934|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
256935|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256936|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256937|NCT01197755|E3|Reported Event|PLACEBO PO|Dosing Group C
256938|NCT01197755|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256939|NCT01197755|E1|Reported Event|FOSTA 100 MG BID PO|Dosing Group A
256940|NCT01197560|B3|Baseline|Total|Total of all reporting groups
256941|NCT01197560|B2|Baseline|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles
Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles
Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide doses:
100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
256942|NCT01197560|B1|Baseline|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256943|NCT01197560|P2|Participant Flow|Investigator's Choice (Control Arm)|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the participant's request and at the investigators' discretion at the same doses mentioned."
256944|NCT01197560|P1|Participant Flow|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256945|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles
Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles
Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide doses:
100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
256946|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256947|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles
Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles
Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide doses:
100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
256948|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256949|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles
Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles
Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide doses:
100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
256950|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256951|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles
Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles
Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide doses:
100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
256952|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256953|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles
Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles
Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide doses:
100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
256954|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256955|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles
Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles
Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide doses:
100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
256956|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256974|NCT01197534|B3|Baseline|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
256975|NCT01197534|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256976|NCT01197534|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
256977|NCT01197534|P3|Participant Flow|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
301988|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
256957|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles
Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles
Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide doses:
100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
256958|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256959|NCT01197560|O2|Outcome|Investigator's Choice|"Investigator’s Choice Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles
Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles
Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide doses:
100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
256960|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256961|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles
Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles
Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide doses:
100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
256962|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256963|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.
Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles
Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles
Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide doses:
100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
256964|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
256965|NCT01197560|E2|Reported Event|Investigator's Choice|"One of the following:
Gemcitabine, Oxaliplatin, Rituximab, or Etoposide
Gemcitabine: Suggested starting doses and regimens for Gemcitabine are 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 every 28 days for 6 Cycles
Oxaliplatin: Suggested starting dose and regimen for Oxaliplatin is 100 mg/m^2 IV day 1 for 21 days for 6 Cycles
Rituximab: Suggested starting dose for Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Etoposide: Suggested starting doses for Etoposide are:
100 mg/m^2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m^2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-10 every 28 days for 6 Cycles"
256966|NCT01197560|E1|Reported Event|Lenalidomide|Lenalidomide: Lenalidomide 25 mg orally for 21 out of every 28 day cycle until progressive disease. For participants with Creatinine Clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg (maximum dose was 15 mg lenalidomide).
256967|NCT01197547|B1|Baseline|Genesys HTA|"Genesys HTA Endometrial Ablation
Genesys HTA: Genesys HTA Endometrial Ablation"
256968|NCT01197547|P1|Participant Flow|Genesys HTA|Genesys HTA Endometrial Ablation
256969|NCT01197547|O1|Outcome|Genesys HTA|Genesys HTA Endometrial Ablation
256970|NCT01197547|O1|Outcome|Genesys HTA|Genesys HTA Endometrial Ablation
256971|NCT01197547|O1|Outcome|Genesys HTA|Genesys HTA Endometrial Ablation
256972|NCT01197547|E1|Reported Event|Genesys HTA|Genesys HTA Endometrial Ablation
256978|NCT01197534|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256979|NCT01197534|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
256980|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
256981|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256982|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256983|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
256984|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256985|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256986|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
256987|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256988|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256989|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
256990|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256991|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256992|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
256993|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256994|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256995|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
256996|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
256997|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
256998|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
256999|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257000|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257001|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257002|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257003|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257004|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257005|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257006|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257007|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257008|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257009|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257010|NCT01197534|O2|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257011|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO (Combined)|Dosing Group A and B combined
257012|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257013|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257014|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257015|NCT01197534|E4|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period|
257016|NCT01197534|E3|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period|Dosing Group C
257017|NCT01197534|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|Dosing Group B
257018|NCT01197534|E1|Reported Event|FOSTA 100 MG BID|Dosing Group A
257019|NCT01197521|B4|Baseline|Total|Total of all reporting groups
257020|NCT01197521|B3|Baseline|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257021|NCT01197521|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257022|NCT01197521|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
257023|NCT01197521|P3|Participant Flow|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257024|NCT01197521|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257025|NCT01197521|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
257026|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257027|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257028|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257029|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257030|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257031|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257032|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257033|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257034|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257035|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257036|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257037|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257038|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257039|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257040|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257041|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257042|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257043|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257044|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257045|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257046|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257047|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257048|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257049|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257050|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257051|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257053|NCT01197521|O2|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257054|NCT01197521|O1|Outcome|FOSTA 100 MG BID (Combined)|Dosing Group A and B combined
257055|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257056|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257057|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257058|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
257059|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
257060|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
257061|NCT01197521|E4|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period|
257062|NCT01197521|E3|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period|Dosing Group C
257063|NCT01197521|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|Dosing Group B
257064|NCT01197521|E1|Reported Event|FOSTA 100 MG BID|Dosing Group A
257065|NCT01197508|B5|Baseline|Total|Total of all reporting groups
257066|NCT01197508|B4|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257067|NCT01197508|B3|Baseline|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257068|NCT01197508|B2|Baseline|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257069|NCT01197508|B1|Baseline|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257070|NCT01197508|P4|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257071|NCT01197508|P3|Participant Flow|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257072|NCT01197508|P2|Participant Flow|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257073|NCT01197508|P1|Participant Flow|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257074|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257075|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257076|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257077|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257078|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257079|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257080|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257081|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257082|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257083|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257084|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257085|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257086|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257087|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257088|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257089|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257090|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257091|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257092|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257093|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257094|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257095|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257096|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257097|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257098|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257099|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
258328|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
257100|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257101|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257102|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257103|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257104|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257105|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257106|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257107|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257108|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257109|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257110|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257111|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257112|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257113|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257114|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257115|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257116|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257117|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257118|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257119|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257120|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257121|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257122|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257123|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257124|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257125|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257126|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257127|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257128|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257129|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257130|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257131|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257132|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257133|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257134|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257135|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257136|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257137|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257138|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257139|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257140|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257141|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257142|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257143|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257144|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257145|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257146|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257147|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257148|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257149|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257150|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257151|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257152|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257153|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257154|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257155|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257156|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257157|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257158|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
257159|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257160|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257161|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257162|NCT01197508|E4|Reported Event|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
257163|NCT01197508|E3|Reported Event|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
257164|NCT01197508|E2|Reported Event|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
257165|NCT01197508|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
257166|NCT01197495|B3|Baseline|Total|Total of all reporting groups
257167|NCT01197495|B2|Baseline|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
257168|NCT01197495|B1|Baseline|Treatment|Juvederm(R) Ultra XC Injectable Gel
257169|NCT01197495|P2|Participant Flow|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
257170|NCT01197495|P1|Participant Flow|Treatment|Juvederm(R) Ultra XC Injectable Gel
257171|NCT01197495|O2|Outcome|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
257172|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
257173|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
257174|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
257175|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
257176|NCT01197495|O2|Outcome|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
257177|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
257178|NCT01197495|E2|Reported Event|Onset After Repeat Treatment|Juvederm(R) Ultra XC Injectable Gel
257179|NCT01197495|E1|Reported Event|Onset Prior to Repeat Treatment|Juvederm(R) Ultra XC Injectable Gel
257180|NCT01197417|B3|Baseline|Total|Total of all reporting groups
257181|NCT01197417|B2|Baseline|Placebo Group|"Normal Saline placebo
Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
257182|NCT01197417|B1|Baseline|Magnesium Group|"Intravenous Magnesium Sulfate
Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
257183|NCT01197417|P2|Participant Flow|Placebo Group|"Normal Saline placebo
Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
257184|NCT01197417|P1|Participant Flow|Magnesium Group|"Intravenous Magnesium Sulfate
Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
257185|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo
Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
257186|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate
Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
257187|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo
Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
258329|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
257188|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate
Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
257189|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo
Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
257190|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate
Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
257191|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo
Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
257192|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate
Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
257193|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo
Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
257194|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate
Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
257195|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo
Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
257196|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate
Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
257197|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo
Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
257198|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate
Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
257199|NCT01197417|E2|Reported Event|Placebo Group|Normal Saline placebo Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses
257200|NCT01197417|E1|Reported Event|Magnesium Group|Intravenous Magnesium Sulfate Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses
257201|NCT01197326|B3|Baseline|Total|Total of all reporting groups
257202|NCT01197326|B2|Baseline|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.
Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
257203|NCT01197326|B1|Baseline|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.
Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
257204|NCT01197326|P2|Participant Flow|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.
Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
257205|NCT01197326|P1|Participant Flow|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.
Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
257206|NCT01197326|O2|Outcome|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.
use of the MP5 EWS patient monitor: All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
257207|NCT01197326|O1|Outcome|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.
use of the MP5 EWS patient monitor: All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
257208|NCT01197326|O2|Outcome|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.
Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
257209|NCT01197326|O1|Outcome|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.
Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
257210|NCT01197326|E2|Reported Event|Patients Who Triggered MET/RRT Calls After the Use of MP5|Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor
257211|NCT01197326|E1|Reported Event|Patients Who Triggered MET/RRT Calls Prior to the Use of MP5|Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor
257212|NCT01196988|B5|Baseline|Total|Total of all reporting groups
257213|NCT01196988|B4|Baseline|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257312|NCT01196975|B2|Baseline|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
258330|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
257214|NCT01196988|B3|Baseline|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257215|NCT01196988|B2|Baseline|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257216|NCT01196988|B1|Baseline|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257217|NCT01196988|P4|Participant Flow|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257218|NCT01196988|P3|Participant Flow|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257219|NCT01196988|P2|Participant Flow|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257220|NCT01196988|P1|Participant Flow|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257221|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257222|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257223|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257224|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257225|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257226|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257227|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257228|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257229|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257230|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257231|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257232|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257233|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257234|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257235|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257236|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257237|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257238|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257239|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257240|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257241|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257242|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257243|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257244|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257245|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257246|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257247|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257248|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257249|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257250|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257251|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257252|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257253|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257254|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257255|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257256|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257257|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257258|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257259|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257260|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257261|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257262|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257263|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257264|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257265|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257266|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257267|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257268|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257269|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257270|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257271|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257272|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257273|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257274|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257275|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257276|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257277|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257278|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257279|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257280|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257281|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257282|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257283|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257284|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257285|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257286|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257287|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257288|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257289|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257290|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257291|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257292|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257293|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257294|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257295|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257296|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257297|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257298|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257299|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257300|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257301|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257302|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257303|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257304|NCT01196988|E4|Reported Event|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257305|NCT01196988|E3|Reported Event|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257306|NCT01196988|E2|Reported Event|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257307|NCT01196988|E1|Reported Event|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
257308|NCT01196975|B6|Baseline|Total|Total of all reporting groups
257309|NCT01196975|B5|Baseline|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257310|NCT01196975|B4|Baseline|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257311|NCT01196975|B3|Baseline|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257313|NCT01196975|B1|Baseline|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
257314|NCT01196975|P5|Participant Flow|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257315|NCT01196975|P4|Participant Flow|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257316|NCT01196975|P3|Participant Flow|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257317|NCT01196975|P2|Participant Flow|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257318|NCT01196975|P1|Participant Flow|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257319|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257320|NCT01196975|O4|Outcome|Victoria Strain FluLaval|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257321|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257322|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257323|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257324|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257325|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257326|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257327|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257328|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257329|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257330|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257331|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257332|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257333|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257334|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257335|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257336|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257337|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257338|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257339|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257340|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257341|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
301989|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
257342|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257343|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257344|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257345|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257346|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257347|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257348|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257349|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257350|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257351|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257352|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
257353|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257354|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257355|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257356|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257357|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257358|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257359|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257360|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257361|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257362|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257363|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257364|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257365|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257366|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257502|NCT01196104|P2|Participant Flow|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257367|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257368|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257369|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257370|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
257371|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257372|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257373|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257374|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257375|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257376|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Yamagata Strain FluLaval Group - Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257377|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257378|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257379|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
257380|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257381|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257382|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257383|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257384|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257385|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257386|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257387|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257388|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257389|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257503|NCT01196104|P1|Participant Flow|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257390|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257391|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257392|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257393|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257394|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257395|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257396|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257397|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257398|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257399|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257400|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257401|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257402|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257403|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
257404|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257405|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257406|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257407|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257408|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257409|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257410|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257411|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257412|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
258331|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
257413|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257414|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
257415|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257416|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257417|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257418|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
257419|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
257420|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257421|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257422|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257423|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257424|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257425|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257426|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257427|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257428|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257429|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257430|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257431|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257432|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257433|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257434|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257435|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257436|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257437|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257438|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257439|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257440|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257441|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257442|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257443|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257444|NCT01196975|E5|Reported Event|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257445|NCT01196975|E4|Reported Event|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257446|NCT01196975|E3|Reported Event|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257447|NCT01196975|E2|Reported Event|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
257448|NCT01196975|E1|Reported Event|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.dominant arm.
257449|NCT01196923|B1|Baseline|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System. Participants with data available are reported so that not all measures may include data from 20 participants.
257450|NCT01196923|P1|Participant Flow|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System
257451|NCT01196923|O1|Outcome|HeartLight Acutely Isolated Pulmonary Veins|
257452|NCT01196923|E1|Reported Event|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System
257453|NCT01196741|B3|Baseline|Total|Total of all reporting groups
257454|NCT01196741|B2|Baseline|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257455|NCT01196741|B1|Baseline|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257456|NCT01196741|P2|Participant Flow|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257457|NCT01196741|P1|Participant Flow|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257458|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257459|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257473|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
257460|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257461|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257462|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257463|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257464|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257465|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257466|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257467|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257468|NCT01196741|E2|Reported Event|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257469|NCT01196741|E1|Reported Event|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
257470|NCT01196442|B1|Baseline|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
257471|NCT01196442|P1|Participant Flow|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
257472|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
257474|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
257475|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
257476|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
257477|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
257478|NCT01196442|O1|Outcome|Arm I|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
Electrical stimulation pain therapy: Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10
Questionnaire administration: Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
257479|NCT01196442|E1|Reported Event|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
257480|NCT01196429|B3|Baseline|Total|Total of all reporting groups
257481|NCT01196429|B2|Baseline|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
257482|NCT01196429|B1|Baseline|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
257483|NCT01196429|P2|Participant Flow|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
257484|NCT01196429|P1|Participant Flow|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
257485|NCT01196429|O2|Outcome|Japan|Patients enrolled from Japan
257486|NCT01196429|O1|Outcome|US/Korea|Patients enrolled from the U.S.and Korea
257487|NCT01196429|O2|Outcome|Japan|Patients enrolled from Japan
257488|NCT01196429|O1|Outcome|US/Korea|Patients enrolled from the U.S.and Korea
257489|NCT01196429|O2|Outcome|Japan|Patients enrolled from Japan
257490|NCT01196429|O1|Outcome|US/Korea|Patients enrolled from the U.S.and Korea
257491|NCT01196429|O2|Outcome|Japan|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
257492|NCT01196429|O1|Outcome|US/Korea|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
257493|NCT01196429|O2|Outcome|Japan|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
257494|NCT01196429|O1|Outcome|US/Korea|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
257495|NCT01196429|O2|Outcome|Japan|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
257496|NCT01196429|O1|Outcome|US/Korea|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
257497|NCT01196429|E2|Reported Event|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
257498|NCT01196429|E1|Reported Event|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
257499|NCT01196104|B3|Baseline|Total|Total of all reporting groups
257500|NCT01196104|B2|Baseline|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257501|NCT01196104|B1|Baseline|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
301990|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
257504|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257505|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257506|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257507|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257508|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257509|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257510|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257511|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257512|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257513|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257514|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257515|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257516|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257517|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257518|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257519|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257520|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257521|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257522|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257523|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257524|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257525|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257526|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257527|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257528|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257529|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257530|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257531|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257532|NCT01196104|O2|Outcome|Comparator|"Insulin Glargine and Insulin Aspart
Insulin Aspart: Usual Care
Insulin Glargine"
257533|NCT01196104|O1|Outcome|Technosphere® Insulin Inhalation Powder (TI)|"Insulin Glargine and Technosphere® Insulin Inhalation Powder
Technosphere® Insulin Inhalation Powder
Insulin Glargine"
257534|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257535|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257536|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257594|NCT01196026|P3|Participant Flow|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257537|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257538|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
257539|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
257540|NCT01196104|E2|Reported Event|Comparator|"Insulin Glargine and Insulin Aspart
Insulin Aspart: Usual Care
Insulin Glargine"
257541|NCT01196104|E1|Reported Event|Technosphere® Insulin Inhalation Powder (TI)|"Insulin Glargine and Technosphere® Insulin Inhalation Powder
Technosphere® Insulin Inhalation Powder
Insulin Glargine"
257542|NCT01196078|B3|Baseline|Total|Total of all reporting groups
257543|NCT01196078|B2|Baseline|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257544|NCT01196078|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257545|NCT01196078|P2|Participant Flow|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 milligrams per square meter (mg/m^2) orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 adverse events [AEs]) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257546|NCT01196078|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 milligrams (mg), tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257547|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257548|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257549|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257550|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257551|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257552|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257553|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257554|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257555|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257556|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257557|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257558|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257559|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257560|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257561|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257562|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
301991|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
257563|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257564|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257565|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257566|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257567|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257568|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257569|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257570|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257571|NCT01196078|E2|Reported Event|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.
Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
257572|NCT01196078|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
257573|NCT01196052|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
257574|NCT01196052|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
257575|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
257576|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
257577|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
257578|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
257579|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
257580|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
257581|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
257582|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
257583|NCT01196052|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
257584|NCT01196026|B7|Baseline|Total|Total of all reporting groups
257585|NCT01196026|B6|Baseline|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257586|NCT01196026|B5|Baseline|Havrix Junior 12-35 Months Group|Subjects aged 12-35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine.
257587|NCT01196026|B4|Baseline|Havrix Junior 6-11 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257588|NCT01196026|B3|Baseline|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257589|NCT01196026|B2|Baseline|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257590|NCT01196026|B1|Baseline|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257591|NCT01196026|P6|Participant Flow|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257592|NCT01196026|P5|Participant Flow|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257593|NCT01196026|P4|Participant Flow|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
258332|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
257595|NCT01196026|P2|Participant Flow|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257596|NCT01196026|P1|Participant Flow|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257597|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257598|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257599|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257600|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257601|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257602|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257603|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257604|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257605|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257606|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257607|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257608|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257609|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257610|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257611|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257612|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257613|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257614|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257615|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257616|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257617|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257618|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257619|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257620|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257621|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257622|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257623|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257624|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257625|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257626|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257627|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
258333|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
257628|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257629|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257630|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257631|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257632|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257633|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257634|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257635|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257636|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257637|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257638|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257639|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257640|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257641|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257642|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257643|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257644|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257645|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257646|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257647|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257648|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257649|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257650|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257651|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257652|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257653|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257654|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257655|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257656|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257657|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257658|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257659|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257660|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257661|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257662|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257663|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257664|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257665|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257666|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257667|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257668|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257669|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257670|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257671|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257672|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257673|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257674|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257675|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257676|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257677|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257678|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257679|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257680|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257681|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257682|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257683|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257684|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257685|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257686|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257687|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257688|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257689|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257690|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257691|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257692|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257693|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257694|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257867|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
257695|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257696|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257697|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257698|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257699|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257700|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257701|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257702|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257703|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257704|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257705|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257706|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257707|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257708|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257709|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257710|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257711|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257712|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257713|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257714|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257715|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257716|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257717|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257718|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257719|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257720|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257721|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257722|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257723|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257724|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257725|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257726|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257727|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257868|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
257728|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257729|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257730|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257731|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257732|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257733|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257734|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257735|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257736|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257737|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257738|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257739|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257740|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257741|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257742|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257743|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257744|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257745|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257746|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257747|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257748|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257749|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257750|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257751|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257752|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257753|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257754|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257755|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257756|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257757|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257758|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257759|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257760|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257761|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257762|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257763|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257764|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257765|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257766|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257767|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257768|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257769|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257770|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257771|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257772|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257773|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257774|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257775|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257776|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257777|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
257778|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257779|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257780|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257781|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257782|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257783|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257784|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257785|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257786|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257787|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257788|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257789|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257790|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257791|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257792|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257793|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257794|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257795|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257796|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257797|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257798|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257799|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257800|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257801|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257802|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257803|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257804|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257805|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257806|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257807|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257808|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257809|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257810|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257811|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257812|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257813|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
257814|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257815|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257816|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257817|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257818|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257819|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257820|NCT01196026|E8|Reported Event|Havrix Junior Group|Subjects received 1 dose of Havrix Junior vacine. The second dose was administered outside the study setting.
257821|NCT01196026|E7|Reported Event|Fluarix Group|subjects received 1 or doses of Fluarix vaccine based on age and priming status
257822|NCT01196026|E6|Reported Event|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257823|NCT01196026|E5|Reported Event|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257824|NCT01196026|E4|Reported Event|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
257825|NCT01196026|E3|Reported Event|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257826|NCT01196026|E2|Reported Event|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257827|NCT01196026|E1|Reported Event|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
257828|NCT01195948|B4|Baseline|Total|Total of all reporting groups
257829|NCT01195948|B3|Baseline|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257830|NCT01195948|B2|Baseline|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257831|NCT01195948|B1|Baseline|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257832|NCT01195948|P3|Participant Flow|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257833|NCT01195948|P2|Participant Flow|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257834|NCT01195948|P1|Participant Flow|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257835|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257836|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257837|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257838|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257839|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257840|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257841|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257842|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257843|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257844|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257845|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257846|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
257847|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD"
257848|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD"
257849|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD"
257850|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD"
257851|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD"
257852|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD"
257912|NCT01195779|P14|Participant Flow|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
257853|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD"
257854|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD"
257855|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD"
257856|NCT01195948|E3|Reported Event|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD"
257857|NCT01195948|E2|Reported Event|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD"
257858|NCT01195948|E1|Reported Event|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD"
257859|NCT01195922|B1|Baseline|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
257860|NCT01195922|P1|Participant Flow|Sirolimus|Rapamycin (sirolimus), dispensed as either tablets or an oral solution for patients with dysphagia was administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Dose reductions to 3 mg by mouth once per day were implemented if levels of rapamycin > 20 ng/ml occurred on Days 8 or 15.
257861|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
257862|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
257863|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
257864|NCT01195922|E1|Reported Event|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
257865|NCT01195844|B1|Baseline|Children Who Provided a Fecal Sample|Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.
257866|NCT01195844|P1|Participant Flow|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
258334|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
257869|NCT01195844|O2|Outcome|Total Number Diagnosed With Rotavirus Diarrhea|Children up to 5 years of age diagnosed with rotavirus diarrhea in the 4 Brazilian hospital research centers
257870|NCT01195844|O1|Outcome|Total Number Hospitalized For Diarrhea of Any Cause|Total number of children up to 5 years of age hospitalized for diarrhea of any cause in the 4 Brazilian hospital research centers
257871|NCT01195844|O1|Outcome|Children Hospitalized For Rotavirus-Positive Diarrhea|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the 4 Brazilian hospital research centers
257872|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea Who Provided a Fecal Sample|Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers
257873|NCT01195844|O4|Outcome|São Paulo (Southeast)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the São Paulo (Southeast Brazil) hospital research center
257874|NCT01195844|O3|Outcome|Porto Alegre (South)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Porto Alegre (South Brazil) hospital research center
257875|NCT01195844|O2|Outcome|Goiânia (Center-West)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Goiânia (Center-West Brazil) hospital research center
257876|NCT01195844|O1|Outcome|Salvador (Northeast)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Salvador (Northeast Brazil) hospital research center
257877|NCT01195844|O1|Outcome|Children Hospitalized for Diarrhea|Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
257878|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
257879|NCT01195844|E1|Reported Event|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
257880|NCT01195831|B3|Baseline|Total|Total of all reporting groups
257881|NCT01195831|B2|Baseline|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
257882|NCT01195831|B1|Baseline|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
257883|NCT01195831|P2|Participant Flow|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
257884|NCT01195831|P1|Participant Flow|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
257885|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
257886|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
257887|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
257888|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
257889|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
257890|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
257891|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
257892|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
257893|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
257894|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
257895|NCT01195831|E2|Reported Event|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
257896|NCT01195831|E1|Reported Event|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
257897|NCT01195779|B15|Baseline|Total|Total of all reporting groups
257898|NCT01195779|B14|Baseline|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
257899|NCT01195779|B13|Baseline|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
257900|NCT01195779|B12|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257901|NCT01195779|B11|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257902|NCT01195779|B10|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257903|NCT01195779|B9|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257904|NCT01195779|B8|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257905|NCT01195779|B7|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257906|NCT01195779|B6|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257907|NCT01195779|B5|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257908|NCT01195779|B4|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257909|NCT01195779|B3|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257910|NCT01195779|B2|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257911|NCT01195779|B1|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257913|NCT01195779|P13|Participant Flow|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
257914|NCT01195779|P12|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257915|NCT01195779|P11|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257916|NCT01195779|P10|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257917|NCT01195779|P9|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257918|NCT01195779|P8|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257919|NCT01195779|P7|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257920|NCT01195779|P6|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257921|NCT01195779|P5|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257922|NCT01195779|P4|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257923|NCT01195779|P3|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257924|NCT01195779|P2|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257925|NCT01195779|P1|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257926|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
257927|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
257928|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257929|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257930|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257931|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257932|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257933|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257934|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257935|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257936|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257937|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257938|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257939|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257940|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
257941|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
257942|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257943|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257944|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257945|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257946|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
301992|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
257947|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257948|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257949|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257950|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257951|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257952|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257953|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257954|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
257955|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
257956|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257957|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257958|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257959|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257960|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257961|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257962|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257963|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257964|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257965|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257966|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257967|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257968|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
257969|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
257970|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257971|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257972|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257973|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257974|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257975|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257976|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257977|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257978|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257979|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257980|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258335|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
301993|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
257981|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257982|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
257983|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
257984|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257985|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257986|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257987|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
257988|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257989|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
257990|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257991|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
257992|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257993|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
257994|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257995|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
257996|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
257997|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
257998|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
257999|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258000|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258001|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258002|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258003|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258004|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258005|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258006|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258007|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258008|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258009|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258010|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
258011|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
258012|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258013|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258014|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258015|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258336|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258016|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258017|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258018|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258019|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258020|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258021|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258022|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258023|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258024|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
258025|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
258026|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258027|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258028|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258029|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258030|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258031|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258032|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258033|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258034|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258035|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258036|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258037|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258038|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
258039|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
258040|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258041|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258042|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258043|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258044|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258045|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258046|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258047|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258048|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258049|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258337|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
301995|NCT00168805|E2|Reported Event|Dabigatran 150mg|qd (once daily) oral
258050|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258051|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258052|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
258053|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
258054|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258055|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258056|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258057|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258058|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258059|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258060|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258061|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258062|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258063|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258064|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258065|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258066|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
258067|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
258068|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258069|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258070|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258071|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258072|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258073|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258074|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258075|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258076|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258077|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258078|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258079|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258080|NCT01195779|E14|Reported Event|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
258081|NCT01195779|E13|Reported Event|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
258082|NCT01195779|E12|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258083|NCT01195779|E11|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
258084|NCT01195779|E10|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258085|NCT01195779|E9|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
258086|NCT01195779|E8|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258087|NCT01195779|E7|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
258088|NCT01195779|E6|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258089|NCT01195779|E5|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
258090|NCT01195779|E4|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258091|NCT01195779|E3|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
258092|NCT01195779|E2|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258093|NCT01195779|E1|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
258094|NCT01195701|B3|Baseline|Total|Total of all reporting groups
258095|NCT01195701|B2|Baseline|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258096|NCT01195701|B1|Baseline|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258097|NCT01195701|P2|Participant Flow|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258098|NCT01195701|P1|Participant Flow|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258099|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258100|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258101|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258102|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258103|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258104|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258105|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258106|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258107|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258108|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258109|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258110|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258111|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258112|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258113|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258114|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258115|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258116|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258117|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258118|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258119|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258120|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258121|NCT01195701|E2|Reported Event|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
258122|NCT01195701|E1|Reported Event|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
258123|NCT01195675|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study.
258159|NCT01195662|P1|Participant Flow|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258124|NCT01195675|P1|Participant Flow|Study Overall|"Total number of patients randomised and treated in the study. This was a randomised, placebo controlled, 5-period crossover trial, participants were randomised to one of ten possible treatment sequences. The treatments administered were
25mg empa administered orally on day 1 of the treatment period
200mg empa administered orally on day 1 of the treatment period
400mg moxifloxacin administered orally on day 1 of the treatment period
Placebo 1 administered orally on day 1 of the treatment period
Placebo 2 administered orally on day 1 of the treatment period
The trial was double-blind for the placebo and Empagliflozin (Empa) treatments, but open-label for the moxifloxacin treatment. A washout period of at least 1 week was respected between drug administrations."
258125|NCT01195675|O4|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
258126|NCT01195675|O3|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
258127|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
258128|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
258129|NCT01195675|O3|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
258130|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (8 tablets of 25 mg)
258131|NCT01195675|O1|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
258132|NCT01195675|O3|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
258133|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
258134|NCT01195675|O1|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
258135|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
258136|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
258137|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
258138|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
258139|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
258140|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
258141|NCT01195675|O2|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
258142|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
258143|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
258144|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
258145|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
258146|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
258147|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
258148|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
258149|NCT01195675|E4|Reported Event|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
258150|NCT01195675|E3|Reported Event|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (8 tablets of 25 mg)
258151|NCT01195675|E2|Reported Event|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
258152|NCT01195675|E1|Reported Event|Placebo|Single oral dose of placebo (8 tablets).
258153|NCT01195662|B4|Baseline|Total|Total of all reporting groups
258154|NCT01195662|B3|Baseline|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|Dapagliflozin: Tablets, Oral, 5 mg, once daily, Up to 12 weeks. This arm discontinued with implementation of Amendment 8 to the protocol (1 November 2011). Study continued to enroll participants in other 2 arms post Amendment 8. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258155|NCT01195662|B2|Baseline|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258156|NCT01195662|B1|Baseline|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258157|NCT01195662|P3|Participant Flow|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
258158|NCT01195662|P2|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258196|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
258197|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
258160|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258161|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258162|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258163|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258164|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258165|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258166|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258167|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258168|NCT01195662|O3|Outcome|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
258169|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258170|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258171|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258172|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258173|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258174|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258198|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
258338|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258175|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258176|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks.Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258177|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258178|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258179|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258180|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258181|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258182|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258183|NCT01195662|E3|Reported Event|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
258184|NCT01195662|E2|Reported Event|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258185|NCT01195662|E1|Reported Event|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
258186|NCT01195636|B3|Baseline|Total|Total of all reporting groups
258187|NCT01195636|B2|Baseline|Placebo First, Then XPF-002|Placebo ointment applied twice daily for 3 weeks followed by XPF-002 ointment applied twice daily for 3 weeks (after a washout period)
258188|NCT01195636|B1|Baseline|XPF-002 First, Then Placebo|XPF-002 ointment applied twice daily for 3 weeks followed by Placebo ointment applied twice daily for 3 weeks (after a washout period)
258189|NCT01195636|P2|Participant Flow|Placebo First, Then XPF-002|In the first intervention period Placebo ointment was applied twice daily for 3 weeks. After a washout period, XPF-002 ointment (8% strength) was applied twice daily for 3 weeks in the second intervention period.
258190|NCT01195636|P1|Participant Flow|XPF-002 First, Then Placebo|In the first intervention period XPF-002 ointment (8% strength) was applied twice daily for 3 weeks. After a washout period, Placebo ointment was applied twice daily for 3 weeks in the second intervention period.
258191|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
258192|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
258193|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
258194|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
258195|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
258326|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258199|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
258200|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
258201|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
258202|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
258203|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
258204|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
258205|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
258206|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
258207|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
258208|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
258209|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
258210|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
258211|NCT01195636|E2|Reported Event|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
258212|NCT01195636|E1|Reported Event|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
258213|NCT01195623|B3|Baseline|Total|Total of all reporting groups
258214|NCT01195623|B2|Baseline|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
258215|NCT01195623|B1|Baseline|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
258216|NCT01195623|P2|Participant Flow|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
258217|NCT01195623|P1|Participant Flow|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
258218|NCT01195623|O2|Outcome|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
258219|NCT01195623|O1|Outcome|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
258220|NCT01195623|O2|Outcome|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
258221|NCT01195623|O1|Outcome|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
258222|NCT01195623|E2|Reported Event|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
258223|NCT01195623|E1|Reported Event|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
258224|NCT01195597|B1|Baseline|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
258225|NCT01195597|P1|Participant Flow|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
258226|NCT01195597|O1|Outcome|Smokers Not Willing to Quit|"7.4 mg nicotine cartridges (Original cartridges; Arbi Group Srl, Milano, Italy)"
258227|NCT01195597|O1|Outcome|Smokers Not Willing to Quit|"7.4 mg nicotine cartridges (Original cartridges; Arbi Group Srl, Milano, Italy)"
258228|NCT01195597|E1|Reported Event|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
258229|NCT01195584|B4|Baseline|Total|Total of all reporting groups
258230|NCT01195584|B3|Baseline|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
258231|NCT01195584|B2|Baseline|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
258232|NCT01195584|B1|Baseline|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
258233|NCT01195584|P3|Participant Flow|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
258234|NCT01195584|P2|Participant Flow|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
258235|NCT01195584|P1|Participant Flow|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
258236|NCT01195584|O1|Outcome|Hospitalization|Days of hospitalization
258237|NCT01195584|O1|Outcome|Hospitalization|Days of hospitalization
258238|NCT01195584|O1|Outcome|Number of Segments|Number of affected spine segments
258239|NCT01195584|O1|Outcome|Blood Loss|
258240|NCT01195584|O1|Outcome|Duration|Duration of surgery
258327|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258241|NCT01195584|O1|Outcome|Complications|Postoperative complications; complications include fever, subfebrile temerature, neurogenic deficit, temorary meningism, pulmonary embolism, TIA, cardiac ischemia, urinary tract infection, respiratory infection and pneumonia
258242|NCT01195584|E3|Reported Event|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
258243|NCT01195584|E2|Reported Event|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
258244|NCT01195584|E1|Reported Event|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
258245|NCT01195467|B1|Baseline|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
258246|NCT01195467|P1|Participant Flow|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
258247|NCT01195467|O1|Outcome|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
258248|NCT01195467|O1|Outcome|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
258249|NCT01195467|E1|Reported Event|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
258250|NCT01195415|B1|Baseline|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
258251|NCT01195415|P1|Participant Flow|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
258252|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
258253|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
258254|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
258255|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
258256|NCT01195415|E1|Reported Event|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
258257|NCT01195363|B3|Baseline|Total|Total of all reporting groups
258258|NCT01195363|B2|Baseline|Quetiapine SR Placebo|mood stabilizer plus quetiapine SR placebo
258259|NCT01195363|B1|Baseline|Active Quetiapine SR|mood stabilizer plus active quetiapine sr
258260|NCT01195363|P2|Participant Flow|Quetiapine sr Placebo 200-600mg, po, qd|mood stabilizer plus quetiapine SR placebo
258261|NCT01195363|P1|Participant Flow|Quetiapine SR, 200-600mg , po, QD|mood stabilizer plus active quetiapine SR
258262|NCT01195363|O2|Outcome|Placebo Quetiapine S.R. 200-600mg, po, qd|mood stabilizer plus quetiapine S.R. placebo
258263|NCT01195363|O1|Outcome|Active Quetiapine S.R., 200-600mg, po, qd|Atypical antipsychotic quetiapine S.R. plus mood stabilizer
258264|NCT01195363|E2|Reported Event|Mood Stabilizer Plus Quetiapine sr Placebo|mood stabilizer plus quetiapine SR placebo
258265|NCT01195363|E1|Reported Event|Mood Stabilizer Plus Quetiapine SR|mood stabilizer plus active quetiapine SR
258266|NCT01195272|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258267|NCT01195272|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) intravenously (IV), once every 4 weeks up to 52 weeks (total of 13 infusions).
258268|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258269|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258270|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258271|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258272|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258273|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258274|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258275|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258276|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258277|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258278|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258279|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258280|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258281|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258282|NCT01195272|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
258283|NCT01195116|B3|Baseline|Total|Total of all reporting groups
258284|NCT01195116|B2|Baseline|Normal Saline|Normal Saline: 1mcg/kg/hr
258285|NCT01195116|B1|Baseline|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.
Dexmedetomidine: 1 mcg/kg/hour"
258286|NCT01195116|P2|Participant Flow|Normal Saline|Normal Saline: 1mcg/kg/hr
258287|NCT01195116|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.
Dexmedetomidine: 1 mcg/kg/hour"
258288|NCT01195116|O2|Outcome|Normal Saline|Normal Saline: 1mcg/kg/hr
258289|NCT01195116|O1|Outcome|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.
Dexmedetomidine: 1 mcg/kg/hour"
258290|NCT01195116|E2|Reported Event|Normal Saline|Normal Saline: 1mcg/kg/hr
258291|NCT01195116|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.
Dexmedetomidine: 1 mcg/kg/hour"
258292|NCT01195103|B4|Baseline|Total|Total of all reporting groups
258293|NCT01195103|B3|Baseline|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
258294|NCT01195103|B2|Baseline|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
258295|NCT01195103|B1|Baseline|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
258296|NCT01195103|P3|Participant Flow|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
258297|NCT01195103|P2|Participant Flow|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
258298|NCT01195103|P1|Participant Flow|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
258299|NCT01195103|O3|Outcome|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
258300|NCT01195103|O2|Outcome|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
258301|NCT01195103|O1|Outcome|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
258302|NCT01195103|E3|Reported Event|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
258303|NCT01195103|E2|Reported Event|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
258304|NCT01195103|E1|Reported Event|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
258305|NCT01195090|B3|Baseline|Total|Total of all reporting groups
258306|NCT01195090|B2|Baseline|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258307|NCT01195090|B1|Baseline|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258308|NCT01195090|P2|Participant Flow|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258309|NCT01195090|P1|Participant Flow|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258310|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258311|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258312|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258313|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258314|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258315|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258316|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258317|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258318|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258319|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258320|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258321|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258322|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258323|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258324|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258325|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
301996|NCT00168805|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
258339|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258340|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258341|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258342|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258343|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258344|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258345|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258346|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258347|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258348|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258349|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258350|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258351|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258352|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258353|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258354|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258355|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258356|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258357|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258358|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258359|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258360|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258361|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258362|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258363|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258364|NCT01195090|E2|Reported Event|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
258365|NCT01195090|E1|Reported Event|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
258366|NCT01195025|B1|Baseline|Dilution Effects of iv Fluids|"Three experiments:
A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxy ethyl starch (HES) 6% 10 mL/kg bodyweight during 30 min C. A combination of A and B. HES during 0-30 min and Ringer's during 105-135 minutes."
258367|NCT01195025|P5|Participant Flow|A. Colloid+Acetated Ringers, B.Colloid and C. Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.
Washout >7 days
Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.
Washout > 7 Days
Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected."
258368|NCT01195025|P4|Participant Flow|A.Colloid, B. Acetated Ringers and C. Colloid+Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.
Washout >7 days
Second intervention: B. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.
Washout > 7 Days
Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples."
258369|NCT01195025|P3|Participant Flow|A. Acetated Ringers, B. Colloid+Acetated Ringers and C.Colloid|"First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by 150 minutes of equilibration, when blood samples were collected
Washout >7 days
Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.
Washout > 7 Days
Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples."
258370|NCT01195025|P2|Participant Flow|A. Colloid, B. Colloid+Acetated Ringers and C.Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.
Washout >7 days
Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.
Washout > 7 Days
Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected"
258371|NCT01195025|P1|Participant Flow|A. Acetated Ringers, B.Colloid and C. Colloid+Acetated Ringers|"First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.
Washout >7 days
Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.
Washout > 7 Days
Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples."
258372|NCT01195025|O1|Outcome|Hydroxyethyl Starch, Ringers and a Combination of Both.|A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes. C. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes.
258373|NCT01195025|O1|Outcome|Colloid (Voluven), Acetated Ringers and a Combination of Both.|"A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes
The combined experiment is not included since infusions were performed in sequence, which made the comparison of the bias for the two different fluids irrelevant."
258413|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
258374|NCT01195025|O1|Outcome|Venous Hemoglobin and Non-invasive Hemoglobin (SpHb)|"A comparison of all paired hemoglobin measurements (B-Hb and SpHb) during the experiments for all the 10 volunteers.
Relative difference(%) = (SpHb - Hb)/((Hb+SpHb)/2) x 100"
258375|NCT01195025|O1|Outcome|Hydroxyethyl Starch, Ringers and a Combination of Both.|A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes. C. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes.
258376|NCT01195025|E1|Reported Event|Colloid-, Acetated Ringers and Combined|"Voluven, acetated Ringers: Infusions at three different occasions separated by at least one week.
A. acetated Ringers 25 ml/kg bodyweight during 30 minutes B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes. C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 15 ml/kg bodyweight during 30 minutes."
258377|NCT01194999|B1|Baseline|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
258378|NCT01194999|P1|Participant Flow|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
258379|NCT01194999|O1|Outcome|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
258380|NCT01194999|E1|Reported Event|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
258381|NCT01194973|B1|Baseline|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258382|NCT01194973|P1|Participant Flow|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258383|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258384|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258385|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258386|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258387|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258388|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258389|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258390|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258391|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258414|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
258392|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258393|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258394|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258395|NCT01194973|E1|Reported Event|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
258396|NCT01194908|B1|Baseline|Arm A|"Patients treated with decitabine and LBH589
Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2
Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2
Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2
Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
258397|NCT01194908|P1|Participant Flow|Arm A|"Patients treated with decitabine and LBH589
Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2
Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2
Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2
Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
258398|NCT01194908|O1|Outcome|Arm A|"Patients treated with decitabine and LBH589
Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2
Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2
Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2
Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
258399|NCT01194908|O1|Outcome|Arm A|"Patients treated with decitabine and LBH589
Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2
Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2
Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2
Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
258400|NCT01194908|E1|Reported Event|Arm A|"Patients treated with decitabine and LBH589
Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2
Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2
Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2
Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
258401|NCT01194869|B1|Baseline|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
258402|NCT01194869|P1|Participant Flow|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
258403|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
258404|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
258405|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
258406|NCT01194869|E1|Reported Event|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
258407|NCT01194856|B3|Baseline|Total|Total of all reporting groups
258408|NCT01194856|B2|Baseline|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
258409|NCT01194856|B1|Baseline|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
258410|NCT01194856|P2|Participant Flow|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
258411|NCT01194856|P1|Participant Flow|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
258412|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
258415|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
258416|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
258417|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
258418|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
258419|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
258420|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
258421|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
258422|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
258423|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
258424|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
258425|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
258426|NCT01194856|O2|Outcome|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
258427|NCT01194856|O1|Outcome|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
258428|NCT01194856|E2|Reported Event|Arm B - Atazanavir/Ritonavir|"Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks"
258429|NCT01194856|E1|Reported Event|Efavirenz 600 mg|"Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks"
258430|NCT01194830|B3|Baseline|Total|Total of all reporting groups
258431|NCT01194830|B2|Baseline|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258432|NCT01194830|B1|Baseline|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258433|NCT01194830|P2|Participant Flow|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258434|NCT01194830|P1|Participant Flow|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258435|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258436|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258437|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258438|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258439|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258440|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258441|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258442|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258443|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258444|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258445|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258446|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258447|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258448|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258449|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258450|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258451|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258452|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258453|NCT01194830|E2|Reported Event|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
258454|NCT01194830|E1|Reported Event|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
258455|NCT01194154|B3|Baseline|Total|Total of all reporting groups
258456|NCT01194154|B2|Baseline|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
258457|NCT01194154|B1|Baseline|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
258458|NCT01194154|P2|Participant Flow|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
258459|NCT01194154|P1|Participant Flow|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
258460|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
258461|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
258462|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
258463|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/ dL.
258464|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
258465|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
258466|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
258467|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
258468|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
258469|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
258470|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
258471|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
258472|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
258473|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
258474|NCT01194154|E2|Reported Event|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
258475|NCT01194154|E1|Reported Event|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
258476|NCT01194089|B3|Baseline|Total|Total of all reporting groups
258477|NCT01194089|B2|Baseline|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
258478|NCT01194089|B1|Baseline|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
258479|NCT01194089|P2|Participant Flow|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
258480|NCT01194089|P1|Participant Flow|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
258481|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
258482|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
258483|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
258484|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
258485|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
258486|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
258487|NCT01194089|E2|Reported Event|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
258488|NCT01194089|E1|Reported Event|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
258489|NCT01194674|B1|Baseline|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
258490|NCT01194674|P1|Participant Flow|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
258491|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
258492|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
258493|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
258494|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
258495|NCT01194674|E1|Reported Event|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
258496|NCT01194531|B3|Baseline|Total|Total of all reporting groups
258497|NCT01194531|B2|Baseline|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.
24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
258498|NCT01194531|B1|Baseline|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
258499|NCT01194531|P2|Participant Flow|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.
24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
258500|NCT01194531|P1|Participant Flow|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
258501|NCT01194531|O2|Outcome|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.
24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
259832|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
258502|NCT01194531|O1|Outcome|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
258503|NCT01194531|E2|Reported Event|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.
24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
258504|NCT01194531|E1|Reported Event|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
258505|NCT01194479|B3|Baseline|Total|Total of all reporting groups
258506|NCT01194479|B2|Baseline|Type 1 Diabetics|"The active group were participants with type 1 diabetes.
Formoterol: Formoterol inhaler, 12mcg capsules, 4 capsules for one administration
Placebo: Participants in both arms received placebo on 1 of the 2 visits."
258507|NCT01194479|B1|Baseline|Healthy Volunteers|"The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.
Formoterol: Formoterol inhaler, 12mcg capsules, 4 capsules for one administration
Placebo: Participants in both arms received placebo on 1 of the 2 visits."
258508|NCT01194479|P4|Participant Flow|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol first, then Placebo.
258509|NCT01194479|P3|Participant Flow|Type 1 Diabetics: Placebo|Type 1 Diabetics that received Placebo first, then Formoterol.
258510|NCT01194479|P2|Participant Flow|Control: Formoterol|Healthy volunteers that received Formoterol first, then Placebo.
258511|NCT01194479|P1|Participant Flow|Control: Placebo|Healthy volunteers that received Placebo first, the Formoterol.
258512|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
258513|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
258514|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
258515|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
258516|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
258517|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
258518|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
258519|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
258520|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
258521|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
258522|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
258523|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
258524|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
258525|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
258526|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
258527|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
258528|NCT01194479|E4|Reported Event|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first visit.
258529|NCT01194479|E3|Reported Event|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first visit.
258530|NCT01194479|E2|Reported Event|Control: Formoterol|Healthy volunteers that received Formoterol on the first visit.
258531|NCT01194479|E1|Reported Event|Control: Placebo|Healthy volunteers that received Placebo on the first visit.
258532|NCT01194453|B3|Baseline|Total|Total of all reporting groups
258533|NCT01194453|B2|Baseline|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
258534|NCT01194453|B1|Baseline|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
258535|NCT01194453|P2|Participant Flow|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
258536|NCT01194453|P1|Participant Flow|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
258537|NCT01194453|O2|Outcome|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
258538|NCT01194453|O1|Outcome|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
258539|NCT01194453|O2|Outcome|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
258558|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
301997|NCT00168818|B4|Baseline|Total|Total of all reporting groups
258540|NCT01194453|O1|Outcome|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
258541|NCT01194453|E2|Reported Event|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
258542|NCT01194453|E1|Reported Event|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
258543|NCT01194440|B1|Baseline|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.
letrozole: Given orally
zoledronic acid: Given IV
laboratory biomarker analysis: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
mass spectrometry: Correlative studies
bone scan: Correlative studies
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
pharmacogenomic studies: Correlative studies
high performance liquid chromatography: Correlative studies"
258544|NCT01194440|P1|Participant Flow|Arm I - IV Zoledronic Acid Prophylaxis|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.
letrozole: Given orally
zoledronic acid: Given IV
laboratory biomarker analysis: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
mass spectrometry: Correlative studies
bone scan: Correlative studies
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
pharmacogenomic studies: Correlative studies
high performance liquid chromatography: Correlative studies"
258545|NCT01194440|O1|Outcome|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.
letrozole: Given orally
zoledronic acid: Given IV
laboratory biomarker analysis: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
mass spectrometry: Correlative studies
bone scan: Correlative studies
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
pharmacogenomic studies: Correlative studies
high performance liquid chromatography: Correlative studies"
258546|NCT01194440|E1|Reported Event|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.
letrozole: Given orally
zoledronic acid: Given IV
laboratory biomarker analysis: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
mass spectrometry: Correlative studies
bone scan: Correlative studies
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
pharmacogenomic studies: Correlative studies
high performance liquid chromatography: Correlative studies"
258547|NCT01194427|B1|Baseline|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
258548|NCT01194427|P1|Participant Flow|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
258549|NCT01194427|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
258550|NCT01194427|E1|Reported Event|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
258551|NCT01194414|B3|Baseline|Total|Total of all reporting groups
258552|NCT01194414|B2|Baseline|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258553|NCT01194414|B1|Baseline|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258554|NCT01194414|P4|Participant Flow|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
258555|NCT01194414|P3|Participant Flow|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258556|NCT01194414|P2|Participant Flow|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258557|NCT01194414|P1|Participant Flow|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258951|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258559|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258560|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258561|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258562|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
258563|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258564|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258565|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258566|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
258567|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258568|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258569|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258570|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258571|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258572|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258573|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258574|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258575|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258952|NCT01193608|O3|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258576|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258577|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258578|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258579|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258580|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
258581|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258582|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258583|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258584|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
258585|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258586|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258587|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258588|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
258589|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258590|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258591|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258592|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
258593|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258594|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258595|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258596|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258597|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258598|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258599|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258600|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258601|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258602|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258603|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258604|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258605|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258606|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
258607|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258608|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258609|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258610|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
303354|NCT00167102|E2|Reported Event|Placebo|
258611|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
258612|NCT01194414|E4|Reported Event|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
258613|NCT01194414|E3|Reported Event|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258614|NCT01194414|E2|Reported Event|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258615|NCT01194414|E1|Reported Event|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
258616|NCT01194297|B3|Baseline|Total|Total of all reporting groups
258617|NCT01194297|B2|Baseline|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations
Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
258618|NCT01194297|B1|Baseline|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations
Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
258619|NCT01194297|P2|Participant Flow|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations
Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
258620|NCT01194297|P1|Participant Flow|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations
Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
258621|NCT01194297|O2|Outcome|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations
Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
258622|NCT01194297|O1|Outcome|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations
Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
258623|NCT01194297|O2|Outcome|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations
Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
258624|NCT01194297|O1|Outcome|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations
Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
258625|NCT01194297|E2|Reported Event|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations
Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
258626|NCT01194297|E1|Reported Event|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations
Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
258627|NCT01194258|B1|Baseline|All Study Participants|All participants in the study, including those who were enrolled but were not randomized.
258628|NCT01194258|P5|Participant Flow|Aspart-PH20, Then Insulin Lispro|"Participants received SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (Aspart-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study."
258629|NCT01194258|P4|Participant Flow|Insulin Lispro, Then Aspart-PH20|"Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (combined: Aspart-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study."
258630|NCT01194258|P3|Participant Flow|Lispro-PH20, Then Insulin Lispro|"Participants received a SC injection of 100 U/mL insulin lispro and 5 µg rHuPH20 (Lispro-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study."
258631|NCT01194258|P2|Participant Flow|Insulin Lispro, Then Lispro-PH20|"Participants received a subcutaneous (SC) injection of 100 units per milliliter (U/mL) insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U insulin lispro and 5 micrograms (µg) recombinant human hyaluronidase PH20 (rHuPH20) (combined: Lispro-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study."
258632|NCT01194258|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 U/mL insulin glulisine, injected SC, pre-meals, with doses titrated to each participant individually.
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258633|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258634|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258635|NCT01194258|O2|Outcome|Insulin-lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258636|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (Insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258637|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258638|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258639|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258640|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258641|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258642|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258643|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258644|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
258645|NCT01194258|E5|Reported Event|Aspart-PH20|"Participants received a SC injection of 100 U/mL insulin aspart and 5 μg rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258646|NCT01194258|E4|Reported Event|Insulin Lispro (Aspart-PH20 Cohort)|"Participants randomized to the Aspart-PH20 cohort.
Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258647|NCT01194258|E3|Reported Event|Lispro-PH20|"Participants received a SC injection of 100 U/mL insulin lispro with 5 micrograms (μg) rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258648|NCT01194258|E2|Reported Event|Insulin Lispro (Lispro-PH20 Cohort)|"Participants randomized to the Lispro-PH20 cohort.
Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258649|NCT01194258|E1|Reported Event|Titration Period|Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.
258650|NCT01194245|B6|Baseline|Total|Total of all reporting groups
258651|NCT01194245|B5|Baseline|Insulin Lispro First, Then Aspart-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.
Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258652|NCT01194245|B4|Baseline|Aspart-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.
Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258653|NCT01194245|B3|Baseline|Insulin Lispro First, Then Lispro-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.
Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258654|NCT01194245|B2|Baseline|Lispro-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.
Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258730|NCT01193920|P8|Participant Flow|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
303355|NCT00167102|E1|Reported Event|Alefacept|
258655|NCT01194245|B1|Baseline|Non-randomized Participants|"Participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
Participants did not complete the titration period or did not meet one or more randomization criteria and, therefore, were not randomized."
258656|NCT01194245|P5|Participant Flow|Insulin Lispro First, Then Aspart-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.
Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258657|NCT01194245|P4|Participant Flow|Aspart-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.
Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258658|NCT01194245|P3|Participant Flow|Insulin Lispro First, Then Lispro-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.
Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258659|NCT01194245|P2|Participant Flow|Lispro-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.
Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258660|NCT01194245|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258661|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258662|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258663|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258664|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258665|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258666|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258667|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258668|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258669|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258670|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258671|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258672|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
258673|NCT01194245|E5|Reported Event|Insulin Lispro (Aspart-PH20 Cohort) Treatment Period|"Participants were randomized to the Aspart-PH20 cohort.
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258674|NCT01194245|E4|Reported Event|Aspart-PH20 Treatment Period|"100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258675|NCT01194245|E3|Reported Event|Insulin Lispro (Lispro-PH20 Cohort) Treatment Period|"Participants were randomized to the Lispro-PH20 cohort.
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258676|NCT01194245|E2|Reported Event|Lispro-PH20 Treatment Period|"100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258677|NCT01194245|E1|Reported Event|Titration Period (All Enrolled Participants)|"Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
258678|NCT01194219|B3|Baseline|Total|Total of all reporting groups
258679|NCT01194219|B2|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
258680|NCT01194219|B1|Baseline|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
258681|NCT01194219|P8|Participant Flow|PBO-APR-APR + Optional Topicals/ UVB|Participants who were initially randomized to placebo BID during the 16-week Placebo-controlled Phase (weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (weeks 16-32). At week 32, those participants who were considered partial responders (ie, having a response of PASI-50 to PASI-74) and those participants who were considered non-responders (ie, having a response of < PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these partial or non-responders received additional topical or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 ans remained on APR 30 mg BID for the remainder of their participation.
258682|NCT01194219|P7|Participant Flow|APR-APR-APR + Optional Topicals/UVB|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At week 32, those participants who were considered partial responders (ie, having a response of PASI-50 to PASI-74) and those participants who were considered non-responders (ie, having a response of <PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
258683|NCT01194219|P6|Participant Flow|APR-APR-Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to APR during the Randomized Withdrawal Phase (weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
258684|NCT01194219|P5|Participant Flow|APR-APR-Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At week 32, those participants who were considered responders [ie, having a ≥ Psoriasis Area and Severity Index score of 75 (PASI-75) response] were re-randomized to PBO during the Randomized Withdrawal Phase (weeks 32-52). Those participants who retained their ≥PASI-75 response through the Randomized Withdrawal Phase remained on PBO until week 52. Those participants who lost their PASI-75 improvement achieved at Week 32, were switched back to APR 30 mg BID at the time loss of effect was observed. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260, and received APR 30 mg BID for the remainder of their participation.
258685|NCT01194219|P4|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to identically matching PBO BID during the Placebo-controlled Phase (weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (weeks 16-32)
258686|NCT01194219|P3|Participant Flow|Apremilast-Apremilast|Participants who were initially randomized to APR 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 30 mg BID during the Maintenance Phase (Weeks 16-32).
258687|NCT01194219|P2|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
258688|NCT01194219|P1|Participant Flow|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
258689|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
258690|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
258691|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (weeks 0-16)
258692|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
258731|NCT01193920|P7|Participant Flow|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258732|NCT01193920|P6|Participant Flow|Pregnant/Placebo|Pregnant women who received one injection of saline solution
303356|NCT00167180|B3|Baseline|Total|Total of all reporting groups
258693|NCT01194219|O2|Outcome|APR-APR -Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who retained their ≥PASI-75 response through the Randomized Withdrawal Phase remained on PBO until Week 52. Those participants who lost their PASI-75 improvement achieved at Week 32, were switched back to APR 30 mg BID at the time loss of effect was observed.
258694|NCT01194219|O1|Outcome|APR-APR-Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to APR during the Randomized Withdrawal Phase (Weeks 32-52).
258695|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
258696|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
258697|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16).
258698|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
258699|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
258700|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
258701|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
258702|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
258703|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
258704|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
258705|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
258706|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
258707|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
258708|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
258709|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
258710|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
258711|NCT01194219|O2|Outcome|Placebo (PBO)|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
258712|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
258713|NCT01194219|E4|Reported Event|Weeks 0-52: APR-Exposure Period|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0 or at week 16), up until Week 52. Adverse events associated with 30 mg apremilast treatment up to Week 52 were included.
258714|NCT01194219|E3|Reported Event|APR-APR-PBO: Weeks 32-52|Participants re-randomized to placebo tablets BID at Week 32. Includes data from Week 32 up to Week 52 when participants received placebo treatment.
258715|NCT01194219|E2|Reported Event|Placebo: Weeks 0-16|Participants randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
258716|NCT01194219|E1|Reported Event|Apremilast: Weeks 0-16|Participants randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
258717|NCT01193920|B11|Baseline|Total|Total of all reporting groups
258718|NCT01193920|B10|Baseline|Infants / Placebo|Infants born from women who received one injection of saline solution
258719|NCT01193920|B9|Baseline|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258720|NCT01193920|B8|Baseline|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258721|NCT01193920|B7|Baseline|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258722|NCT01193920|B6|Baseline|Pregnant/Placebo|Pregnant women who received one injection of saline solution
258723|NCT01193920|B5|Baseline|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258724|NCT01193920|B4|Baseline|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258725|NCT01193920|B3|Baseline|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258726|NCT01193920|B2|Baseline|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
258727|NCT01193920|B1|Baseline|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
258728|NCT01193920|P10|Participant Flow|Infants / Placebo|Infants born from women who received saline solution
258729|NCT01193920|P9|Participant Flow|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
259833|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
258733|NCT01193920|P5|Participant Flow|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258734|NCT01193920|P4|Participant Flow|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258735|NCT01193920|P3|Participant Flow|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258736|NCT01193920|P2|Participant Flow|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
258737|NCT01193920|P1|Participant Flow|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
258738|NCT01193920|O4|Outcome|Infants / Placebo|Infants born from women who received saline solution
258739|NCT01193920|O3|Outcome|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258740|NCT01193920|O2|Outcome|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258741|NCT01193920|O1|Outcome|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258742|NCT01193920|O4|Outcome|Infants / Placebo|Infants born from women who received saline solution
258743|NCT01193920|O3|Outcome|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258744|NCT01193920|O2|Outcome|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258745|NCT01193920|O1|Outcome|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258746|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
258747|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258748|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258749|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258750|NCT01193920|O2|Outcome|Non Pregnant/Placebo|Non pregnant women received two injections of saline solution
258751|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
258752|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
258753|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
258754|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
258755|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
258756|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
258757|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258758|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258759|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258760|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
258761|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258762|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258763|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258764|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
258765|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258766|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258767|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258768|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
258769|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258770|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258771|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258772|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
258773|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
258774|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
258775|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
258776|NCT01193920|E10|Reported Event|Infants / Placebo|Infants born from women who received one injection of saline solution
258777|NCT01193920|E9|Reported Event|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258778|NCT01193920|E8|Reported Event|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258779|NCT01193920|E7|Reported Event|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258780|NCT01193920|E6|Reported Event|Pregnant/Placebo|Pregnant women who received one injection of saline solution
258781|NCT01193920|E5|Reported Event|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
258782|NCT01193920|E4|Reported Event|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
258783|NCT01193920|E3|Reported Event|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
258784|NCT01193920|E2|Reported Event|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
258785|NCT01193920|E1|Reported Event|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
258786|NCT01193907|B5|Baseline|Total|Total of all reporting groups
258787|NCT01193907|B4|Baseline|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
258788|NCT01193907|B3|Baseline|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
258789|NCT01193907|B2|Baseline|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
258790|NCT01193907|B1|Baseline|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
258791|NCT01193907|P4|Participant Flow|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
258792|NCT01193907|P3|Participant Flow|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
258793|NCT01193907|P2|Participant Flow|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
258794|NCT01193907|P1|Participant Flow|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
258795|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
258796|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
258797|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
258798|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
258799|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
258800|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
258801|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
258802|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
258803|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
258804|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
258805|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
258806|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
258807|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
258808|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
258809|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
258810|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
258811|NCT01193907|E4|Reported Event|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
258812|NCT01193907|E3|Reported Event|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
258813|NCT01193907|E2|Reported Event|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
258814|NCT01193907|E1|Reported Event|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
258815|NCT01193868|B1|Baseline|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258816|NCT01193868|P1|Participant Flow|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258817|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258818|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258819|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258820|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258821|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258822|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258823|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258824|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258825|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258826|NCT01193868|E1|Reported Event|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
258827|NCT01193686|B3|Baseline|Total|Total of all reporting groups
258828|NCT01193686|B2|Baseline|Recipients of Peer Visitors|Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and were initiating rehabilitation therapies.
258829|NCT01193686|B1|Baseline|Veteran Peer Visitors|Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabiliation were recruited for training as peer mentors.
258830|NCT01193686|P2|Participant Flow|Recipients of PV|9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
258831|NCT01193686|P1|Participant Flow|Veteran Peer Visitors|Of the 15 (52%) PV who enrolled in the study and completed the baseline assessment, 4 (27%) withdrew prior to PV training due to moving out of state (3) or schedule limitations (n=1). One was removed from the study by investigators due to discovery of invalid reporting.
258832|NCT01193686|O2|Outcome|Recipients of PV|
258833|NCT01193686|O1|Outcome|Veteran Peer Visitors|
258834|NCT01193686|O2|Outcome|Recipients of PV|
258835|NCT01193686|O1|Outcome|Veteran Peer Visitors|
258836|NCT01193686|O2|Outcome|Recipients of PV|
258837|NCT01193686|O1|Outcome|Veteran Peer Visitors|
258838|NCT01193686|O2|Outcome|Recipients of PV|
258839|NCT01193686|O1|Outcome|Veteran Peer Visitors|
258840|NCT01193686|O2|Outcome|Recipients of PV|9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
258841|NCT01193686|O1|Outcome|Veteran Peer Visitors|
258842|NCT01193686|E2|Reported Event|Recipients of Veteran Peer Visitation|Veterans of Operation Enduring Freedom or Operation Iraqi Freedom who sustained polytrauma (i.e., mutiple systems involved) injuries.
258843|NCT01193686|E1|Reported Event|Veteran Peer Visitors|Veteran Peer Visitors (VPV) who participated in a 2-day training program and then provided at 1-5 visits to at least 2 recipients. All Peer Visitors had served in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabilitation.
258844|NCT01193660|B4|Baseline|Total|Total of all reporting groups
258845|NCT01193660|B3|Baseline|Only Rehabilitation|Active rehabilitation
258846|NCT01193660|B2|Baseline|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258847|NCT01193660|B1|Baseline|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258848|NCT01193660|P3|Participant Flow|Only Rehabilitation|Active rehabilitation
258849|NCT01193660|P2|Participant Flow|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258850|NCT01193660|P1|Participant Flow|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258851|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
258852|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258853|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258854|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
258855|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258856|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258857|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
258858|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258859|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258860|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
258861|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258862|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258863|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
258864|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258865|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258866|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
258867|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258948|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258949|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258868|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258869|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
258870|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258871|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258872|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
258873|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258874|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258875|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
258876|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258877|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258878|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
258879|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258880|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258881|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
258882|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258883|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258884|NCT01193660|E3|Reported Event|Only Rehabilitation|Active rehabilitation
258885|NCT01193660|E2|Reported Event|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
258886|NCT01193660|E1|Reported Event|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
258887|NCT01193608|B7|Baseline|Total|Total of all reporting groups
258888|NCT01193608|B6|Baseline|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258889|NCT01193608|B5|Baseline|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258890|NCT01193608|B4|Baseline|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258891|NCT01193608|B3|Baseline|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258892|NCT01193608|B2|Baseline|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258893|NCT01193608|B1|Baseline|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258894|NCT01193608|P6|Participant Flow|Placebo|Participants received placebo matched to AAB-003 1-hour IV infusion (infusion of placebo matched to AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
258895|NCT01193608|P5|Participant Flow|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
258896|NCT01193608|P4|Participant Flow|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
258897|NCT01193608|P3|Participant Flow|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
258898|NCT01193608|P2|Participant Flow|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
258950|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258899|NCT01193608|P1|Participant Flow|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 milligram/kilogram (mg/kg) 1-hour intravenous (IV) infusion (infusion of AAB-003 and 20 milliliter (mL) normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
258900|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258901|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258902|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258903|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258904|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258905|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258906|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258907|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258908|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258909|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258910|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258911|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258912|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258913|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258914|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258915|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258916|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258917|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258918|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258919|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258920|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258921|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258922|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258923|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258924|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258925|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258926|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258927|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258928|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258929|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258930|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258931|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258932|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258933|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258934|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258935|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258936|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258937|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258938|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258939|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258940|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258941|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258942|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258943|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258944|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258945|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258946|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258947|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
306087|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
258953|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258954|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258955|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258956|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258957|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258958|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258959|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258960|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258961|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258962|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258963|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258964|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258965|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258966|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258967|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258968|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258969|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258970|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258971|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258972|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258973|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258974|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258975|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258976|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258977|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258978|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258979|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258980|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258981|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258982|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258983|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258984|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258985|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258986|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258987|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258988|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258989|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258990|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258991|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258992|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258993|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258994|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258995|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258996|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258997|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
258998|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
258999|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259000|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259001|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259002|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259003|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
259004|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259005|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259006|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259007|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259008|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259009|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
259010|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259011|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259012|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259013|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259014|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259015|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259016|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259017|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259018|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259019|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259020|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259021|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259022|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259023|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259024|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259025|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259026|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259027|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259028|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259029|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259030|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259031|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259032|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259033|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259034|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259035|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259036|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259037|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259038|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259039|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259040|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259041|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259042|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259043|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259044|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259045|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259046|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259047|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259048|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259049|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259050|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259051|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259052|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259053|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259054|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
306088|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
259055|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259056|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259057|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259058|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259059|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259060|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259061|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259062|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259063|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259064|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259065|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259066|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259067|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259068|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259069|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259070|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259071|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259072|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259073|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259074|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259075|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259076|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259077|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259078|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259079|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259080|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259081|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259082|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259083|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259084|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259085|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259086|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259087|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259088|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259089|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259090|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259091|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259092|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259093|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259094|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259095|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
259096|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259097|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259098|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259099|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259100|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259101|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
259102|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259103|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259104|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259105|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
306103|NCT00196313|B3|Baseline|Total|Total of all reporting groups
259106|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259107|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
259108|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259109|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259110|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259111|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259112|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259113|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
259114|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259115|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259116|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259117|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259118|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259119|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
259120|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259121|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259122|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259123|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259124|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259125|NCT01193608|E6|Reported Event|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
259126|NCT01193608|E5|Reported Event|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259127|NCT01193608|E4|Reported Event|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259128|NCT01193608|E3|Reported Event|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259129|NCT01193608|E2|Reported Event|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259130|NCT01193608|E1|Reported Event|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
259131|NCT01193582|B5|Baseline|Total|Total of all reporting groups
259132|NCT01193582|B4|Baseline|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
259133|NCT01193582|B3|Baseline|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
259134|NCT01193582|B2|Baseline|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
259135|NCT01193582|B1|Baseline|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
259136|NCT01193582|P4|Participant Flow|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
259137|NCT01193582|P3|Participant Flow|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
259138|NCT01193582|P2|Participant Flow|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
259139|NCT01193582|P1|Participant Flow|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
259140|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
259141|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
259142|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
259143|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
259144|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
259145|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
259146|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
259147|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
259148|NCT01193582|O1|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
259149|NCT01193582|O1|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
259150|NCT01193582|O1|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
259151|NCT01193582|O1|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
259152|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
259153|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
259154|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
259155|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
259156|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
259157|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
259158|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
259159|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
259160|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
259161|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
259162|NCT01193582|E4|Reported Event|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
259163|NCT01193582|E3|Reported Event|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
259164|NCT01193582|E2|Reported Event|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
259165|NCT01193582|E1|Reported Event|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
259166|NCT01193556|B3|Baseline|Total|Total of all reporting groups
259167|NCT01193556|B2|Baseline|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
259168|NCT01193556|B1|Baseline|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
259169|NCT01193556|P2|Participant Flow|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
259170|NCT01193556|P1|Participant Flow|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
259171|NCT01193556|O2|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
259172|NCT01193556|O1|Outcome|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
259173|NCT01193556|O2|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
259174|NCT01193556|O1|Outcome|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
259175|NCT01193556|E2|Reported Event|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
259176|NCT01193556|E1|Reported Event|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
259177|NCT01193348|B1|Baseline|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259178|NCT01193348|P1|Participant Flow|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259179|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|≥40kg weight cohort
259180|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|30 – <40kg weight cohort
259181|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|20 – <30kg weight cohort
259182|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|10 – <20kg weight cohort
259183|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|5 – <10kg weight cohort
259184|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259185|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259186|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259187|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259188|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259189|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259190|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259191|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259192|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259193|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259194|NCT01193348|E1|Reported Event|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
259195|NCT01193335|B3|Baseline|Total|Total of all reporting groups
259196|NCT01193335|B2|Baseline|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259197|NCT01193335|B1|Baseline|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259198|NCT01193335|P2|Participant Flow|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259199|NCT01193335|P1|Participant Flow|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259200|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
306104|NCT00196313|B2|Baseline|Placebo|Placebo, 1 tablet daily
259201|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259202|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259203|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259204|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259205|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259206|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259207|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259208|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259209|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259210|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259211|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259212|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259213|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259214|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259215|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259216|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259217|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259218|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259219|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259220|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259221|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259222|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259223|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259224|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259370|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
259225|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259226|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259227|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259228|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259229|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259230|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259231|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259232|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259233|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259234|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259235|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259236|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259237|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259238|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259239|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259240|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259241|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259242|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259243|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm infant participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259244|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259245|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259246|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259247|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259248|NCT01193335|O3|Outcome|13vPnC Group 1C|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259249|NCT01193335|O2|Outcome|13vPnC Group 1B|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259250|NCT01193335|O1|Outcome|13vPnC Group 1A|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259251|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259834|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259252|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259253|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259254|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259255|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259256|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259257|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259258|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259259|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259260|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259261|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259262|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259263|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259264|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259265|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259266|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259267|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259268|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259269|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259270|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259271|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259371|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
259272|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259273|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259274|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259275|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259276|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259277|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259278|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259279|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259280|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259281|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
259282|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
259283|NCT01193335|E10|Reported Event|13vPnC Group 2 (Term Infant) - 2 Year Follow-up|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
259284|NCT01193335|E9|Reported Event|13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
259285|NCT01193335|E8|Reported Event|13vPnC Group 2 (Term Infant) - 1 Year Follow-up|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
259286|NCT01193335|E7|Reported Event|13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
259287|NCT01193335|E6|Reported Event|13vPnC Group 2 (Term Infant) - Toddler Dose|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
259288|NCT01193335|E5|Reported Event|13vPnC Group 1 (Preterm Infant) - Toddler Dose|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
259289|NCT01193335|E4|Reported Event|13vPnC Group 2 (Term Infant) - After Infant Series|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
259290|NCT01193335|E3|Reported Event|13vPnC Group 1 (Preterm Infant) - After Infant Series|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
259291|NCT01193335|E2|Reported Event|13vPnC Group 2 (Term Infant) - Infant Series|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
259313|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259292|NCT01193335|E1|Reported Event|13vPnC Group 1 (Preterm Infant) - Infant Series|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
259293|NCT01193283|B1|Baseline|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.
Cyclophosphamide: 30 my/kg for 4 days
Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
259294|NCT01193283|P1|Participant Flow|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.
Cyclophosphamide: 30 my/kg for 4 days
Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
259295|NCT01193283|O1|Outcome|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.
Cyclophosphamide: 30 my/kg for 4 days
Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
259296|NCT01193283|E1|Reported Event|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.
Cyclophosphamide: 30 my/kg for 4 days
Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
259297|NCT01193244|B3|Baseline|Total|Total of all reporting groups
259298|NCT01193244|B2|Baseline|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259299|NCT01193244|B1|Baseline|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259300|NCT01193244|P2|Participant Flow|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259301|NCT01193244|P1|Participant Flow|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259302|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259303|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259304|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259305|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259306|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259307|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259308|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259309|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259310|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259311|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259312|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259314|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259315|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259316|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259317|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259318|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259319|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259320|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259321|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259322|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259323|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259324|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259325|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259326|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259327|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259328|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259329|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259330|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259331|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259332|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259333|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259334|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259335|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259336|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259337|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259338|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259339|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259340|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259341|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259342|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259343|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259344|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259345|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259346|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259347|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259348|NCT01193244|E2|Reported Event|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259349|NCT01193244|E1|Reported Event|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
259350|NCT01193218|B6|Baseline|Total|Total of all reporting groups
259351|NCT01193218|B5|Baseline|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
259352|NCT01193218|B4|Baseline|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
259353|NCT01193218|B3|Baseline|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
259354|NCT01193218|B2|Baseline|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
259355|NCT01193218|B1|Baseline|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
259356|NCT01193218|P8|Participant Flow|Empa 50 mg/25 mg|It is actually N/A in the 12-week first treatment period, and empagliflozin 50 mg/25 mg once daily group in the 40-week second treatment period
259357|NCT01193218|P7|Participant Flow|Empa 50mg\10mg|It is actually empagliflozin 50 mg once daily group in the 12-week first treatment period, and empagliflozin 50 mg/10 mg once daily group in the 40-week second treatment period
259358|NCT01193218|P6|Participant Flow|Empa 25mg|Empagliflozin 25 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
259359|NCT01193218|P5|Participant Flow|Empa 10mg|Empagliflozin 10 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
259360|NCT01193218|P4|Participant Flow|Empa 5 mg/25 mg|It is actually N/A in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
259361|NCT01193218|P3|Participant Flow|Empa 5mg/10mg|It is actually empagliflozin 5 mg once daily group in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
259362|NCT01193218|P2|Participant Flow|Placebo/Empa 25 mg|It is actually N/A in the 12-week first treatment period, and placebo/empagliflozin 25 mg once daily group in the 40-week second treatment period
259363|NCT01193218|P1|Participant Flow|Placebo/Empa 10mg|It is actually placebo once daily group in the 12-week first treatment period, and placebo/empagliflozin 10 mg once daily group in the 40-week second treatment period
259364|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
259365|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
259366|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
259367|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
259368|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
259369|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
259372|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
259373|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
259374|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
259375|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
259376|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
259377|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
259378|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
259379|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
259380|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
259381|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
259382|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
259383|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
259384|NCT01193218|E9|Reported Event|Empa 25mg (With at Least One Dose, 52 Week)|Patients with at least one dose of empagliflozin 25 mg once daily for 52−week treatment
259385|NCT01193218|E8|Reported Event|Empa 10mg (With at Least One Dose, 52 Week)|Patients with at least one dose of empagliflozin 10 mg once daily for 52−week treatment
259386|NCT01193218|E7|Reported Event|Empa 25mg (Randomized, 52 Week)|Patients randomized to empagliflozin 25 mg once daily for 52 weeks
259387|NCT01193218|E6|Reported Event|Empa 10mg (Randomized, 52 Week)|Patients randomized to empagliflozin 10mg once daily for 52 weeks
259388|NCT01193218|E5|Reported Event|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
259389|NCT01193218|E4|Reported Event|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
259390|NCT01193218|E3|Reported Event|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
259391|NCT01193218|E2|Reported Event|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
259392|NCT01193218|E1|Reported Event|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
259393|NCT01193153|B1|Baseline|Entire Study Population|Included all participants who received at least 1 dose of paliperidone palmitate in open-label lead in period.
259394|NCT01193153|P2|Participant Flow|Placebo|Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks during double-blind relapse prevention period.
259395|NCT01193153|P1|Participant Flow|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period. DB Relapse prevention period (15 months): Same dose as Day 92 once every 4 weeks until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
259396|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259397|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
259398|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
259399|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259400|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259401|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
259402|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
259422|NCT01193153|E3|Reported Event|Double Blind - Placebo|Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants during DB relapse prevention period.
259835|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259403|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259404|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259405|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
259406|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
259407|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259408|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259409|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
259410|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
259411|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259412|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259413|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
259414|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259415|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
259416|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
259417|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259418|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259419|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
259420|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
259421|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
259423|NCT01193153|E2|Reported Event|Double Blind - Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
259424|NCT01193153|E1|Reported Event|Open Label - Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period.
259425|NCT01193127|B5|Baseline|Total|Total of all reporting groups
259426|NCT01193127|B4|Baseline|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259427|NCT01193127|B3|Baseline|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259428|NCT01193127|B2|Baseline|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259429|NCT01193127|B1|Baseline|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259430|NCT01193127|P4|Participant Flow|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259431|NCT01193127|P3|Participant Flow|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259432|NCT01193127|P2|Participant Flow|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259433|NCT01193127|P1|Participant Flow|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259434|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259435|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259436|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259437|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259438|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259439|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259440|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259441|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259442|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259443|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259444|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259445|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259446|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259447|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259448|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259449|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259450|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259451|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259452|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259453|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259454|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259455|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259456|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259457|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259458|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259459|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259460|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259461|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259462|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259463|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259464|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259465|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259466|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259467|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259468|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259469|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259470|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259471|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259472|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259473|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259474|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259475|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259476|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259477|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259478|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259479|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259480|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259481|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259482|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259483|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259484|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259485|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259486|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259487|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259488|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259489|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259490|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259491|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259492|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259493|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259494|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259495|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259496|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259497|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259498|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259499|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259500|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259501|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259502|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259503|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259504|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259505|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259506|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259507|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259508|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259509|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259510|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259511|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259512|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259513|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259514|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259515|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259516|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259517|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259518|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259519|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259520|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259521|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259522|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259523|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259524|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259525|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259526|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259527|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259528|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259529|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259530|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259531|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259532|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259533|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259534|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259535|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259536|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259537|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259538|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259539|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259540|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259541|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259542|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259543|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259544|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259545|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259546|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259547|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259548|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259549|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259550|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259551|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259552|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259553|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259554|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259555|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259556|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259557|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259558|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259559|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259560|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259561|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259562|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259563|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259564|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259565|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259566|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259567|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259568|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259569|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259570|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259571|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259572|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259573|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259574|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259575|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259576|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259577|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259578|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259579|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259580|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259581|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259582|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259583|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259584|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259585|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259586|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259587|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259588|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259589|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259590|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259591|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259592|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259593|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259594|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259595|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259596|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259597|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259598|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259599|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259600|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259601|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS) Solution|"Balanced Salt Solution (BSS) Solution
Balanced Salt Solution (BSS) Solution"
259602|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259603|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259604|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259605|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS) Solution|"Balanced Salt Solution (BSS) Solution
Balanced Salt Solution (BSS) Solution"
259606|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259607|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259608|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259609|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259610|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259611|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259612|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259613|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259614|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259615|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259616|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259617|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259618|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259619|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259620|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259621|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259622|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259623|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259624|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259625|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259626|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259627|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259628|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259629|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259630|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259631|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259632|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259633|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259634|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259635|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259636|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259637|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259638|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259639|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259640|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259641|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259642|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259643|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259644|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259645|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259646|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259647|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259648|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259649|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259650|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259651|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259652|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259653|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259654|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259655|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259656|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259657|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259658|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259659|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259660|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259661|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259662|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259663|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259664|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259665|NCT01193127|O1|Outcome|Solution|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259666|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259667|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259668|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259669|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259670|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259671|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259672|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259673|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259674|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259675|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259676|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259677|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259678|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259679|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259680|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259681|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259682|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259683|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259684|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259685|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259686|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259687|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259688|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259689|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259690|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259691|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259692|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259693|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259694|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259695|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259696|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259697|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259698|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259699|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259700|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259701|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259702|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259703|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259704|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259705|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259706|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259707|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259708|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259709|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259710|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259711|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259712|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259713|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259714|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259715|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259716|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259717|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259718|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259719|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259720|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259721|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259722|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259723|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259724|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259725|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259726|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259727|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259728|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259729|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259730|NCT01193127|E4|Reported Event|OMS302 Solution|"OMS302 Solution
OMS302 Solution"
259731|NCT01193127|E3|Reported Event|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution"
259732|NCT01193127|E2|Reported Event|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution
OMS302 Mydriatic Solution"
259733|NCT01193127|E1|Reported Event|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS)"
259734|NCT01193114|B3|Baseline|Total|Total of all reporting groups
259735|NCT01193114|B2|Baseline|Treatment as Usual|The Mothers were offered services provided through the family shelter.
259736|NCT01193114|B1|Baseline|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
259737|NCT01193114|P2|Participant Flow|Treatment as Usual|The Mothers were offered services provided through the family shelter.
259738|NCT01193114|P1|Participant Flow|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
259739|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
259740|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
259741|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
259742|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
259743|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
259744|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
259745|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
259746|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
259747|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
259785|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259748|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
259749|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
259750|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
259751|NCT01193114|E2|Reported Event|Treatment as Usual|The Mothers were offered services provided through the family shelter.
259752|NCT01193114|E1|Reported Event|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
259753|NCT01193101|B5|Baseline|Total|Total of all reporting groups
259754|NCT01193101|B4|Baseline|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259755|NCT01193101|B3|Baseline|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259756|NCT01193101|B2|Baseline|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259757|NCT01193101|B1|Baseline|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259758|NCT01193101|P4|Participant Flow|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259759|NCT01193101|P3|Participant Flow|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259760|NCT01193101|P2|Participant Flow|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259761|NCT01193101|P1|Participant Flow|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259762|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259763|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259764|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259765|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259766|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259767|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259768|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259769|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259770|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259771|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259772|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259773|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259774|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259775|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259776|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259777|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259778|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259779|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259780|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259781|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259782|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259783|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259784|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259831|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259786|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259787|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259788|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259789|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259790|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259791|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259792|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259793|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259794|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259795|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259796|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259797|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259798|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259799|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259800|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259801|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259802|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259803|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259804|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259805|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259806|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259807|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259808|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259809|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259810|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259811|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259812|NCT01193101|E4|Reported Event|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
259813|NCT01193101|E3|Reported Event|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
259814|NCT01193101|E2|Reported Event|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259815|NCT01193101|E1|Reported Event|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
259816|NCT01193049|B1|Baseline|All Participants|All randomized participants
259817|NCT01193049|P2|Participant Flow|Placebo, Then Prednisone|Placebo in the first double blind treatment period and prednisone in the second double blind treatment period
259818|NCT01193049|P1|Participant Flow|Prednisone, Then Placebo|Prednisone in the first double blind treatment period and placebo in the second double blind treatment period
259819|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259820|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259821|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259822|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259823|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259824|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259825|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259826|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259827|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259828|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259829|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259830|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259836|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259837|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259838|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259839|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259840|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259841|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259842|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259843|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
259844|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
259845|NCT01193049|E2|Reported Event|Placebo|All participants who received at least one dose of placebo
259846|NCT01193049|E1|Reported Event|Prednisone|All participants who received at least one dose of prednisone
259847|NCT01192776|B5|Baseline|Total|Total of all reporting groups
259848|NCT01192776|B4|Baseline|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259849|NCT01192776|B3|Baseline|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259850|NCT01192776|B2|Baseline|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259851|NCT01192776|B1|Baseline|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259852|NCT01192776|P4|Participant Flow|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259853|NCT01192776|P3|Participant Flow|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259854|NCT01192776|P2|Participant Flow|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259855|NCT01192776|P1|Participant Flow|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259856|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259857|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259858|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259859|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259860|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259861|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259862|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259863|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259864|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259865|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259866|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259867|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259868|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259936|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
259869|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259870|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259871|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259872|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259873|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259874|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259875|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259876|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259877|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259878|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259879|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259880|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259881|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259882|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259883|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259884|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259885|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259886|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259887|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259888|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259889|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259890|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259891|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259892|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259893|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259894|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259934|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
259895|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259896|NCT01192776|O4|Outcome|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259897|NCT01192776|O3|Outcome|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259898|NCT01192776|O2|Outcome|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259899|NCT01192776|O1|Outcome|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259900|NCT01192776|E4|Reported Event|32.0°C for 120 Hours|"Target Temp: 32.0°C Duration:120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259901|NCT01192776|E3|Reported Event|33.5°C for 120 Hours|"Target Temp: 33.5°C Duration: 120 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259902|NCT01192776|E2|Reported Event|32.0°C for 72 Hours|"Target Temp: 32.0°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259903|NCT01192776|E1|Reported Event|33.5°C for 72 Hours|"Target Temp: 33.5°C Duration: 72 hrs
Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours."
259904|NCT01192698|B3|Baseline|Total|Total of all reporting groups
259905|NCT01192698|B2|Baseline|no Treatment|standard of care for liver transplant
259906|NCT01192698|B1|Baseline|IV Interferon|"IV interferon oral ribavirin
Aims The purpose of this study was to determine the safety and effect of intravenous interferon (IFN) during the anhepatic phase of LT on hepatitis C viral load. Methods Fifteen consecutive subjects undergoing liver transplant for hepatitis C cirrhosis were enrolled in the study, ten of which received study drug and five subjects served as controls. Cases received weight-based ribavirin and subcutaneous IFN at time of incision followed by intravenous IFN at the start of the anhepatic phase."
259907|NCT01192698|P2|Participant Flow|no Treatment|standard of care
259908|NCT01192698|P1|Participant Flow|IV Interferon|"IV interferon oral ribavirin
IV interferon: IV interferon 5MU during anhepatic phase"
259909|NCT01192698|O2|Outcome|no Treatment|standard of care for liver transplant
259910|NCT01192698|O1|Outcome|IV Interferon|"IV interferon oral ribavirin
Aims The purpose of this study was to determine the safety and effect of intravenous interferon (IFN) during the anhepatic phase of LT on hepatitis C viral load. Methods Fifteen consecutive subjects undergoing liver transplant for hepatitis C cirrhosis were enrolled in the study, ten of which received study drug and five subjects served as controls. Cases received weight-based ribavirin and subcutaneous IFN at time of incision followed by intravenous IFN at the start of the anhepatic phase."
259911|NCT01192698|E2|Reported Event|no Treatment|standard of care for liver transplant
259912|NCT01192698|E1|Reported Event|IV Interferon|"IV interferon oral ribavirin
IV interferon: IV interferon 5MU during anhepatic phase"
259913|NCT01192542|B1|Baseline|All Subjects|All subjects who enrolled in the study.
259914|NCT01192542|P2|Participant Flow|Enfilcon A Lens/Galyfilcon A Prototype Lens|The enfilcon A contact lens worn daily for 6-8 days first then the galyfilcon A prototype contact lens worn daily for 6-8 days second.
259915|NCT01192542|P1|Participant Flow|Galyfilcon A Prototype Lens/Enfilcon A Lens|The galyfilcon A prototype contact lens worn daily for 6-8 days first then the enfilcon A contact lens worn daily for 6-8 days second.
259916|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
259917|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel lens.
259918|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel contact lens.
259919|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel contact lens.
259920|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
259921|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicon hydrogel contact lens.
259922|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
259923|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel lens.
259924|NCT01192542|E1|Reported Event|All Subjects|All subjects who exposed to the Investigation lenses.
259925|NCT01192516|B4|Baseline|Total|Total of all reporting groups
259926|NCT01192516|B3|Baseline|Arm 3|Usual care group
259927|NCT01192516|B2|Baseline|Arm 2|"General activity pacing and symptom management
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
259928|NCT01192516|B1|Baseline|Arm 1|"Tailored activity pacing
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
259929|NCT01192516|P3|Participant Flow|Usual Care Group|Participants receiving usual care
259930|NCT01192516|P2|Participant Flow|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
259931|NCT01192516|P1|Participant Flow|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
259932|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
259933|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
259935|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
259937|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
259938|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
259939|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
259940|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
259941|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
259942|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
259943|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
259944|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
259945|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
259946|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
259947|NCT01192516|O3|Outcome|Arm 3|Usual care group
259948|NCT01192516|O2|Outcome|Arm 2|"General activity pacing and symptom management
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
259949|NCT01192516|O1|Outcome|Arm 1|"Tailored activity pacing
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
259950|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
259951|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
259952|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
259953|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
259954|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
259955|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
259956|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
259957|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
259958|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
259959|NCT01192516|E3|Reported Event|Arm 3|Usual care group
259960|NCT01192516|E2|Reported Event|Arm 2|"General activity pacing and symptom management
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
259961|NCT01192516|E1|Reported Event|Arm 1|"Tailored activity pacing
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
259962|NCT01192412|B3|Baseline|Total|Total of all reporting groups
259963|NCT01192412|B2|Baseline|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
259964|NCT01192412|B1|Baseline|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
259965|NCT01192412|P2|Participant Flow|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
259966|NCT01192412|P1|Participant Flow|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
259967|NCT01192412|O2|Outcome|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
259968|NCT01192412|O1|Outcome|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
260012|NCT01192282|B3|Baseline|Persistent Cases|The warts presence after completion of treatment
260013|NCT01192282|B2|Baseline|Recurrent Cases|Reappearance of genital warts at 3 or 6 months post-treatment in participants free of warts at completion of treatment
259969|NCT01192412|O2|Outcome|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
259970|NCT01192412|O1|Outcome|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
259971|NCT01192412|E2|Reported Event|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
259972|NCT01192412|E1|Reported Event|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
259973|NCT01192347|B1|Baseline|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259974|NCT01192347|P1|Participant Flow|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259975|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259976|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259977|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259978|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259979|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259980|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259981|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259982|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259983|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259984|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259985|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259986|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259987|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259988|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259989|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259990|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259991|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259992|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259993|NCT01192347|E1|Reported Event|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
259994|NCT01192295|B3|Baseline|Total|Total of all reporting groups
259995|NCT01192295|B2|Baseline|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
259996|NCT01192295|B1|Baseline|6 to < 12 Years|Children 6 to < 12 years of age
259997|NCT01192295|P2|Participant Flow|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
259998|NCT01192295|P1|Participant Flow|6 to < 12 Years|Children 6 to < 12 years of age
259999|NCT01192295|O1|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
260000|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
260001|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
260002|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
260003|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
260004|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
260005|NCT01192295|O1|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
260006|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
260007|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
260008|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
260009|NCT01192295|E2|Reported Event|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
260010|NCT01192295|E1|Reported Event|6 to < 12 Years|Children 6 to < 12 years of age
260011|NCT01192282|B4|Baseline|Total|Total of all reporting groups
306105|NCT00196313|B1|Baseline|Seasonique|"Seasonique
, 1 tablet daily"
260014|NCT01192282|B1|Baseline|New Cases|Newly diagnosed cases of genital warts
260015|NCT01192282|P1|Participant Flow|Number of Participants|Participants with Genital Warts
260016|NCT01192282|O2|Outcome|HIV Negative|Number of participants with HIV Negative
260017|NCT01192282|O1|Outcome|HIV Positive|Number of participants with HIV Positive
260018|NCT01192282|O3|Outcome|HIV Unknown|Participants who Refused HIV Testing
260019|NCT01192282|O2|Outcome|HIV Negative|Participants with HIV Negative
260020|NCT01192282|O1|Outcome|HIV Positive|Participants with HIV Positive
260021|NCT01192282|O2|Outcome|HPV DNA Negative|Participants with HPV DNA Negative
260022|NCT01192282|O1|Outcome|HPV DNA Positive|Participants with HPV DNA Positive
260023|NCT01192282|O3|Outcome|HIV Unknown|Number of participants who refused HIV Testing
260024|NCT01192282|O2|Outcome|HIV Negative|Number of participants with HIV Negative
260025|NCT01192282|O1|Outcome|HIV Positive|Number of participants with HIV Positive
260026|NCT01192282|E3|Reported Event|HIV Unknown|Participants with Genital Warts whom HIV Status was Unknown
260027|NCT01192282|E2|Reported Event|HIV Negative|Participants with Genital Warts who were HIV Negative
260028|NCT01192282|E1|Reported Event|HIV Positive|Participants with Genital Warts who were HIV Positive
260029|NCT01192204|B3|Baseline|Total|Total of all reporting groups
260030|NCT01192204|B2|Baseline|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel
Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
260031|NCT01192204|B1|Baseline|10% FBR Gel|"Active 10% FBR containing bioadhesive gel
Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
260032|NCT01192204|P2|Participant Flow|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel
Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
260033|NCT01192204|P1|Participant Flow|10% FBR Gel|"Active 10% FBR containing bioadhesive gel
Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
260034|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel
Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
260035|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel
Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
260036|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel
Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
260037|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel
Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months."
260038|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel
Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
260039|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel
Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
260040|NCT01192204|E2|Reported Event|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel
Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months
No adverse events"
260041|NCT01192204|E1|Reported Event|10% FBR Gel|"Active 10% FBR containing bioadhesive gel
Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months
No adverse events"
260042|NCT01192191|B3|Baseline|Total|Total of all reporting groups
260043|NCT01192191|B2|Baseline|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260044|NCT01192191|B1|Baseline|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260045|NCT01192191|P2|Participant Flow|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260046|NCT01192191|P1|Participant Flow|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260047|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260048|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260049|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260050|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260051|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260052|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260053|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260054|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
261218|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
260055|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260056|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260057|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260058|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260059|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260060|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260061|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260062|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260063|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260064|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260065|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260066|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260067|NCT01192191|E2|Reported Event|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
260068|NCT01192191|E1|Reported Event|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
260069|NCT01192178|B3|Baseline|Total|Total of all reporting groups
260070|NCT01192178|B2|Baseline|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
260071|NCT01192178|B1|Baseline|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
260072|NCT01192178|P2|Participant Flow|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
260073|NCT01192178|P1|Participant Flow|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
260074|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
260075|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
260076|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
260077|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
260078|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
260079|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
260080|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
260081|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
260082|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
260083|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
260084|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
260085|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
260086|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
260087|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
260088|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
260089|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
260090|NCT01192178|E2|Reported Event|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
260091|NCT01192178|E1|Reported Event|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
260092|NCT01192152|B1|Baseline|All Enrolled and Treated Participants|
260093|NCT01192152|P2|Participant Flow|Treatment Sequence BA|Treatment B (period 1):Fixed dose combination (FDC) tablet (5 mg saxa + 1000 mg metformin XR), single dose, under fed conditions; Treatment A (period 2): 5 mg saxagliptin + 2 Glucophage XR 500 mg under fed conditions. Participants underwent a 2-day washout period between Periods 1 and 2.
260137|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260138|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260094|NCT01192152|P1|Participant Flow|Treatment Sequence ABC|Treatment A (period 1): 5 mg saxagliptin + 2 Glucophage XR 500 mg under fed conditions; Treatment B (period 2):Fixed dose combination (FDC) tablet (5 mg saxa + 1000 mg metformin XR), single dose, under fed conditions; Treatment C (period 3): FDC tablet (5 mg saxa + 1000 mg metformin XR), once daily for 4 days, under fed conditions. Participants underwent a 2-day washout period between Periods 1 and 2. There was no washout between Periods 2 and 3.
260095|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260096|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260097|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260098|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260099|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260100|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260101|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260102|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260103|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260104|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260105|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260106|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260107|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260108|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260109|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260110|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260111|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260112|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260113|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260114|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260115|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260116|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260117|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260118|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260119|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260120|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260121|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260122|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260123|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260124|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260125|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260126|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260127|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260128|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260129|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260130|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260131|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260132|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260133|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260134|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260135|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260136|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260139|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260140|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260141|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260142|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260143|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260144|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260145|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260146|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260147|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260148|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260149|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260150|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260151|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260152|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260153|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260154|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260155|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260156|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260157|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260158|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260159|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260160|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260161|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260162|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260163|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260164|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260165|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260166|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260167|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260168|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260169|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260170|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260171|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260172|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260173|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260174|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260175|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260176|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260177|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260178|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260179|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260180|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260181|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260182|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260183|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260184|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260185|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260186|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260187|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260188|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260189|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260190|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260191|NCT01192152|E3|Reported Event|Saxa 5mg/500mg Metformin, Fed 4 Days|FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
260192|NCT01192152|E2|Reported Event|Saxa 5mg/1000mg Metformin, Fed|Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
260193|NCT01192152|E1|Reported Event|Saxa 5mg + 2x500mg Metformin, Fed|5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
260194|NCT01192139|B1|Baseline|All Enrolled and Treated Participants|
260195|NCT01192139|P6|Participant Flow|Treatment Sequence CBA|Treatment C (period 1): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment B (period 2): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment A (period 3): 5 mg saxagliptin + a single 500 mg metformin XR tablet. Participants underwent at least a 3-day washout period between each treatment.
260196|NCT01192139|P5|Participant Flow|Treatment Sequence CAB|Treatment C (period 1): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment A (period 2): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment B (period 3): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions. Participants underwent at least a 3-day washout period between each treatment.
260197|NCT01192139|P4|Participant Flow|Treatment Sequence BCA|Treatment B (period 1): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment C (period 2): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment A (period 3): 5 mg saxagliptin + a single 500 mg metformin XR tablet. Participants underwent at least a 3-day washout period between each treatment.
260198|NCT01192139|P3|Participant Flow|Treatment Sequence BAC|Treatment B (period 1): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment A (period 2): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment C (period 3): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions. Participants underwent at least a 3-day washout period between each treatment.
260199|NCT01192139|P2|Participant Flow|Treatment Sequence ACB|Treatment A (period 1): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment C (period 2): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment B (period 3): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions. Participants underwent at least a 3-day washout period between each treatment.
260200|NCT01192139|P1|Participant Flow|Treatment Sequence ABC|Treatment A (period 1): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment B (period 2): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment C (period 3): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions. Participants underwent at least a 3-day washout period between each treatment.
260201|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260202|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260203|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260204|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260205|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260206|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260207|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260208|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260209|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260210|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260211|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260212|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260213|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260214|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260215|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260216|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260258|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260217|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260218|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260219|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260220|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260221|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260222|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260223|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260224|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260225|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260226|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260227|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260228|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260229|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260230|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260231|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260232|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260233|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260234|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260235|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260236|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260237|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260238|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260239|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260240|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260241|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260242|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260243|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260244|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260245|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260246|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260247|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260248|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260249|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260250|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260251|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260252|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260253|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260254|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260255|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260256|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260257|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260259|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260260|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260261|NCT01192139|E3|Reported Event|Treatment B|Fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
260262|NCT01192139|E2|Reported Event|Treatment C|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
260263|NCT01192139|E1|Reported Event|Treatment A|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
260264|NCT01192126|B1|Baseline|Overall Study|All eligible subjects
260265|NCT01192126|P2|Participant Flow|J & J Acuvue Moist, Then B & L Daily Disposable Lens|Johnson & Johnson Acuvue Moist lenses are to be worn for approximately one week. Crossover to Bausch & Lomb new daily disposable lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
260266|NCT01192126|P1|Participant Flow|B & L Daily Disposable Lens, Then J & J Acuvue Moist|Bausch & Lomb new daily disposable lenses are to be worn for approximately one week. Crossover to Johnson & Johnson Acuvue Moist lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
260267|NCT01192126|O2|Outcome|Johnson & Johnson Acuvue Moist|"Contact lenses
Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
260268|NCT01192126|O1|Outcome|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses
Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
260269|NCT01192126|O2|Outcome|Johnson & Johnson Acuvue Moist|"Contact lenses
Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
260270|NCT01192126|O1|Outcome|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses
Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
260271|NCT01192126|E2|Reported Event|Johnson & Johnson Acuvue Moist|"Contact lenses
Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
260272|NCT01192126|E1|Reported Event|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses
Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
260273|NCT01192022|B5|Baseline|Total|Total of all reporting groups
260274|NCT01192022|B4|Baseline|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260275|NCT01192022|B3|Baseline|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260276|NCT01192022|B2|Baseline|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260277|NCT01192022|B1|Baseline|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260278|NCT01192022|P5|Participant Flow|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260279|NCT01192022|P4|Participant Flow|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260280|NCT01192022|P3|Participant Flow|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260281|NCT01192022|P2|Participant Flow|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260282|NCT01192022|P1|Participant Flow|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260283|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260284|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260285|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260286|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260389|NCT01191788|E1|Reported Event|Group CBT|Clients received up to 16 sessions of group CBT for depression
260287|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260288|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260289|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260290|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260291|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260292|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260293|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260294|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260295|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260296|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260297|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260298|NCT01192022|E4|Reported Event|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260299|NCT01192022|E3|Reported Event|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260300|NCT01192022|E2|Reported Event|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260301|NCT01192022|E1|Reported Event|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
260302|NCT01191944|B3|Baseline|Total|Total of all reporting groups
260303|NCT01191944|B2|Baseline|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260304|NCT01191944|B1|Baseline|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260305|NCT01191944|P2|Participant Flow|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260306|NCT01191944|P1|Participant Flow|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260307|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260308|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260309|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260310|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260311|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260312|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260313|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260314|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260315|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260316|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260317|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260318|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260319|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260320|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260321|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260322|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260323|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260324|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260325|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260326|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260327|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260328|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260329|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260330|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260331|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260332|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260333|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260334|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260335|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260336|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260337|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260338|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260339|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260340|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260341|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260342|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260390|NCT01191762|B3|Baseline|Total|Total of all reporting groups
260343|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260344|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260345|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260346|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260347|NCT01191944|E2|Reported Event|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
260348|NCT01191944|E1|Reported Event|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
260349|NCT01191827|B3|Baseline|Total|Total of all reporting groups
260350|NCT01191827|B2|Baseline|Clozapine|Patients with schizophrenia treated with clozapine
260351|NCT01191827|B1|Baseline|Risperidone|Patients with schizophrenia treated with risperidone
260352|NCT01191827|P2|Participant Flow|Clozapine|Patients with schizophrenia treated with clozapine
260353|NCT01191827|P1|Participant Flow|Risperidone|Patients with schizophrenia treated with risperidone
260354|NCT01191827|O2|Outcome|Clozapine|Patients with schizophrenia treated with clozapine
260355|NCT01191827|O1|Outcome|Risperidone|Patients with schizophrenia treated with risperidone
260356|NCT01191827|E2|Reported Event|Clozapine|Patients with schizophrenia treated with clozapine
260357|NCT01191827|E1|Reported Event|Risperidone|Patients with schizophrenia treated with risperidone
260358|NCT01191801|B3|Baseline|Total|Total of all reporting groups
260359|NCT01191801|B2|Baseline|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
260360|NCT01191801|B1|Baseline|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
260361|NCT01191801|P2|Participant Flow|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
260362|NCT01191801|P1|Participant Flow|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
260363|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
260364|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
260365|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
260366|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
260367|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
260368|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
260369|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
260370|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
260371|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
260372|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
260373|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
260374|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
260375|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
260376|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
260377|NCT01191801|E2|Reported Event|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
260378|NCT01191801|E1|Reported Event|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
260379|NCT01191788|B3|Baseline|Total|Total of all reporting groups
260380|NCT01191788|B2|Baseline|Comparison|Treatment as Usual comparison condition
260381|NCT01191788|B1|Baseline|Group CBT|Clients received up to 16 sessions of group CBT for depression
260382|NCT01191788|P2|Participant Flow|Comparison|Treatment as Usual comparison condition
260383|NCT01191788|P1|Participant Flow|Group CBT|Clients received up to 16 sessions of group CBT for depression
260384|NCT01191788|O2|Outcome|Comparison|Usual care.
260385|NCT01191788|O1|Outcome|Group CBT|Usual care + BRIGHT intervention. The BRIGHT intervention included 16 two-hour group sessions of CBT for depression.
260386|NCT01191788|O2|Outcome|Comparison|Usual care
260387|NCT01191788|O1|Outcome|Group CBT|Usual care + BRIGHT intervention. The BRIGHT intervention included 16 two-hour group sessions of CBT for depression.
260388|NCT01191788|E2|Reported Event|Comparison|Treatment as Usual comparison condition
260391|NCT01191762|B2|Baseline|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.
placebo : 3 tablets with each meal"
260392|NCT01191762|B1|Baseline|Sevelamer Carbonate|"2400 mg (3 pills) with each meal
sevelamer carbonate : 2400 mg with each meal for 4 weeks"
260393|NCT01191762|P2|Participant Flow|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.
placebo : 3 tablets with each meal"
260394|NCT01191762|P1|Participant Flow|Sevelamer Carbonate|"2400 mg (3 pills) with each meal
sevelamer carbonate : 2400 mg with each meal for 4 weeks"
260395|NCT01191762|O2|Outcome|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.
placebo : 3 tablets with each meal"
260396|NCT01191762|O1|Outcome|Sevelamer Carbonate|"2400 mg (3 pills) with each meal
sevelamer carbonate : 2400 mg with each meal for 4 weeks"
260397|NCT01191762|E2|Reported Event|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.
placebo : 3 tablets with each meal"
260398|NCT01191762|E1|Reported Event|Sevelamer Carbonate|"2400 mg (3 pills) with each meal
sevelamer carbonate : 2400 mg with each meal for 4 weeks"
260399|NCT01191749|B1|Baseline|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
260400|NCT01191749|P1|Participant Flow|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
260401|NCT01191749|O1|Outcome|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
260402|NCT01191749|E1|Reported Event|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
260403|NCT01191736|B8|Baseline|Total|Total of all reporting groups
260404|NCT01191736|B7|Baseline|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
260405|NCT01191736|B6|Baseline|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
260406|NCT01191736|B5|Baseline|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
260407|NCT01191736|B4|Baseline|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
260408|NCT01191736|B3|Baseline|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
260409|NCT01191736|B2|Baseline|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
260410|NCT01191736|B1|Baseline|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
260411|NCT01191736|P7|Participant Flow|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
260412|NCT01191736|P6|Participant Flow|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
260413|NCT01191736|P5|Participant Flow|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
260414|NCT01191736|P4|Participant Flow|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
260415|NCT01191736|P3|Participant Flow|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
260416|NCT01191736|P2|Participant Flow|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
260417|NCT01191736|P1|Participant Flow|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
260418|NCT01191736|O7|Outcome|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
260419|NCT01191736|O6|Outcome|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
260420|NCT01191736|O5|Outcome|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
260421|NCT01191736|O4|Outcome|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
260422|NCT01191736|O3|Outcome|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
260423|NCT01191736|O2|Outcome|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
260424|NCT01191736|O1|Outcome|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
260425|NCT01191736|O7|Outcome|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
260426|NCT01191736|O6|Outcome|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
260427|NCT01191736|O5|Outcome|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
260428|NCT01191736|O4|Outcome|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
260429|NCT01191736|O3|Outcome|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
260430|NCT01191736|O2|Outcome|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
260431|NCT01191736|O1|Outcome|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
260432|NCT01191736|E7|Reported Event|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
260433|NCT01191736|E6|Reported Event|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
260434|NCT01191736|E5|Reported Event|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
260435|NCT01191736|E4|Reported Event|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
260436|NCT01191736|E3|Reported Event|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
260437|NCT01191736|E2|Reported Event|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
260438|NCT01191736|E1|Reported Event|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
260439|NCT01191723|B1|Baseline|All Subjects|All subjects enrolled in the study.
260440|NCT01191723|P6|Participant Flow|Treatment C, Then B, Then A|Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
260441|NCT01191723|P5|Participant Flow|Treatment C, Then A, Then B|"Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4."
260442|NCT01191723|P4|Participant Flow|Treatment B, Then C, Then A|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
260443|NCT01191723|P3|Participant Flow|Treatment B, Then A, Then C|"Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment C = inhaler placebo and placebo capsules at Visit 4."
260444|NCT01191723|P2|Participant Flow|Treatment A, Then C, Then B|"Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4."
260445|NCT01191723|P1|Participant Flow|Treatment A, Then B, Then C|"Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4."
260446|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
260447|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
260448|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
260449|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
260450|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
260451|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
260452|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
260453|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules.
260454|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
260455|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
260456|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
260457|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
260458|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules.
260459|NCT01191723|E3|Reported Event|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet
260460|NCT01191723|E2|Reported Event|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules
260461|NCT01191723|E1|Reported Event|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules
260462|NCT01191476|B4|Baseline|Total|Total of all reporting groups
260463|NCT01191476|B3|Baseline|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
260464|NCT01191476|B2|Baseline|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
260465|NCT01191476|B1|Baseline|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
260466|NCT01191476|P3|Participant Flow|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
260467|NCT01191476|P2|Participant Flow|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
260468|NCT01191476|P1|Participant Flow|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
260469|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
260470|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
260471|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
260472|NCT01191476|O3|Outcome|Propofol Induction and Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
260473|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
260474|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
260475|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
260476|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
260477|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
260478|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
260479|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
260480|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
260481|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
260482|NCT01191476|O2|Outcome|Propofol|IV Propofol for induction and maintenance of anesthesia
261219|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
260483|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
260484|NCT01191476|E3|Reported Event|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
260485|NCT01191476|E2|Reported Event|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
260486|NCT01191476|E1|Reported Event|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
260487|NCT01191411|B4|Baseline|Total|Total of all reporting groups
260488|NCT01191411|B3|Baseline|Visit Based Care|"No invitation to complete colorectal cancer screening.
Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.
Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
260489|NCT01191411|B2|Baseline|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.
Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.
Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
260490|NCT01191411|B1|Baseline|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.
Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.
Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
260491|NCT01191411|P3|Participant Flow|Visit Based Care|"No invitation to complete colorectal cancer screening.
Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.
Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
260492|NCT01191411|P2|Participant Flow|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.
Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.
Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
260493|NCT01191411|P1|Participant Flow|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.
Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.
Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
260494|NCT01191411|O3|Outcome|Visit Based Care|"No invitation to complete colorectal cancer screening.
Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.
Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
260495|NCT01191411|O2|Outcome|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.
Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.
Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
260496|NCT01191411|O1|Outcome|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.
Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.
Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
260497|NCT01191411|E3|Reported Event|Visit Based Care|"No invitation to complete colorectal cancer screening.
Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.
Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
260498|NCT01191411|E2|Reported Event|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.
Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.
Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
260499|NCT01191411|E1|Reported Event|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.
Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.
Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
260500|NCT01191398|B4|Baseline|Total|Total of all reporting groups
260501|NCT01191398|B3|Baseline|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
260502|NCT01191398|B2|Baseline|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
260503|NCT01191398|B1|Baseline|Placebo|"Normal Saline0.9% will act as a placebo.
Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
260504|NCT01191398|P3|Participant Flow|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
260505|NCT01191398|P2|Participant Flow|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
260506|NCT01191398|P1|Participant Flow|Placebo|"Normal Saline0.9% will act as a placebo.
Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
260507|NCT01191398|O3|Outcome|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
260508|NCT01191398|O2|Outcome|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
260509|NCT01191398|O1|Outcome|Placebo|"Normal Saline0.9% will act as a placebo.
Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
260510|NCT01191398|O3|Outcome|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
260511|NCT01191398|O2|Outcome|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
260512|NCT01191398|O1|Outcome|Placebo|"Normal Saline0.9% will act as a placebo.
Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
260513|NCT01191398|E3|Reported Event|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
260514|NCT01191398|E2|Reported Event|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
260515|NCT01191398|E1|Reported Event|Placebo|"Normal Saline0.9% will act as a placebo.
Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
260516|NCT01191320|B4|Baseline|Total|Total of all reporting groups
260517|NCT01191320|B3|Baseline|Androxal 25 mg|"25 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
260518|NCT01191320|B2|Baseline|Androxal 12.5 mg|"12.5 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
260519|NCT01191320|B1|Baseline|Placebo|"Placebo
Placebo: Placebo capsule 1x daily for 3 months"
260520|NCT01191320|P3|Participant Flow|Androxal 25 mg|"25 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
260521|NCT01191320|P2|Participant Flow|Androxal 12.5 mg|"12.5 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
260522|NCT01191320|P1|Participant Flow|Placebo|"Placebo
Placebo: Placebo capsule 1x daily for 3 months"
260523|NCT01191320|O3|Outcome|Androxal 25 mg|"25 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
260524|NCT01191320|O2|Outcome|Androxal 12.5 mg|"12.5 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
260525|NCT01191320|O1|Outcome|Placebo|"Placebo
Placebo: Placebo capsule 1x daily for 3 months"
260526|NCT01191320|E3|Reported Event|Androxal 25 mg|"25 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
260527|NCT01191320|E2|Reported Event|Androxal 12.5 mg|"12.5 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
260528|NCT01191320|E1|Reported Event|Placebo|"Placebo
Placebo: Placebo capsule 1x daily for 3 months"
260529|NCT01191268|B4|Baseline|Total|Total of all reporting groups
260530|NCT01191268|B3|Baseline|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260531|NCT01191268|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260532|NCT01191268|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
261220|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
260533|NCT01191268|P3|Participant Flow|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260534|NCT01191268|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260535|NCT01191268|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260536|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260537|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260538|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260539|NCT01191268|O1|Outcome|1.5 mg or 0.75 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg , subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260540|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260541|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260542|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260543|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260544|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260545|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260546|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260547|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260548|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260549|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260550|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260551|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260552|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260553|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260554|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260555|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260556|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260557|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260558|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260972|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260559|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260560|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260561|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260562|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260563|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260564|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260565|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260566|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260567|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260568|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260569|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260570|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260571|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260572|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260573|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260574|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260575|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260576|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260577|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260578|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260579|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260580|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260581|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260582|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260583|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260584|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260611|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260585|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260586|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260587|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260588|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260589|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260590|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260591|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260592|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260593|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260594|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260595|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260596|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260597|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260598|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260599|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260600|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260601|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260602|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260603|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260604|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260605|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260606|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260607|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260608|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260609|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260610|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260748|NCT01190813|B1|Baseline|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260612|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260613|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260614|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260615|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260616|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260617|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260618|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260619|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260620|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260621|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260622|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260623|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260624|NCT01191268|E3|Reported Event|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260625|NCT01191268|E2|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260626|NCT01191268|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
260627|NCT01191255|B5|Baseline|Total|Total of all reporting groups
260628|NCT01191255|B4|Baseline|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260629|NCT01191255|B3|Baseline|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260630|NCT01191255|B2|Baseline|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.
Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
260631|NCT01191255|B1|Baseline|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
260632|NCT01191255|P4|Participant Flow|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260633|NCT01191255|P3|Participant Flow|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260634|NCT01191255|P2|Participant Flow|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.
Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
260635|NCT01191255|P1|Participant Flow|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
260636|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260637|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260638|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.
Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
260639|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
260640|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260641|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260642|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.
Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
260643|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
260644|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260645|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260646|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.
Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
260647|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
260648|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260649|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260650|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.
Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
260651|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
260652|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260653|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
260654|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.
Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
260655|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
260656|NCT01191255|E4|Reported Event|Placebo (EAP)|Efficacy Assessment Period (Week 52-56)
260657|NCT01191255|E3|Reported Event|KRX-0502 (EAP)|Efficacy Assessment Period (Week 52-56)
260658|NCT01191255|E2|Reported Event|Active Control (SAP)|Safety Assessment Period (Week 1-52)
260659|NCT01191255|E1|Reported Event|KRX-0502 (SAP)|Safety Assessment Period (Week 1-52)
260660|NCT01191242|B1|Baseline|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260661|NCT01191242|P1|Participant Flow|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260662|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260663|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260664|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260665|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260666|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260667|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260668|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260669|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260670|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260671|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260672|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260673|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260674|NCT01191242|E1|Reported Event|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
260675|NCT01191190|B1|Baseline|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260676|NCT01191190|P1|Participant Flow|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260677|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260678|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260679|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260680|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260681|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260682|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260683|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260684|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260685|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260749|NCT01190813|P2|Participant Flow|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
261221|NCT01189890|E2|Reported Event|Glimepiride|Glimepiride 1-6 mg QD
260686|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260687|NCT01191190|E1|Reported Event|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.
Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
260688|NCT01191086|B1|Baseline|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255"
260689|NCT01191086|P1|Participant Flow|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255"
260690|NCT01191086|O1|Outcome|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255"
260691|NCT01191086|E1|Reported Event|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255"
260692|NCT01191008|B1|Baseline|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
260693|NCT01191008|P1|Participant Flow|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
260694|NCT01191008|O1|Outcome|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
260695|NCT01191008|O1|Outcome|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
260696|NCT01191008|O1|Outcome|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
260697|NCT01191008|E1|Reported Event|Latanoprost/Timolol Maleate|Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.
260698|NCT01190891|B3|Baseline|Total|Total of all reporting groups
260699|NCT01190891|B2|Baseline|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL
Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
260700|NCT01190891|B1|Baseline|Manual Physical Therapy|Manual Physical Therapy: Same as arm description
260701|NCT01190891|P2|Participant Flow|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL
Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
260702|NCT01190891|P1|Participant Flow|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.
Manual Physical Therapy: Same as arm description"
260703|NCT01190891|O2|Outcome|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL
Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
260704|NCT01190891|O1|Outcome|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.
Manual Physical Therapy: Same as arm description"
260705|NCT01190891|O2|Outcome|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL
Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
260706|NCT01190891|O1|Outcome|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.
Manual Physical Therapy: Same as arm description"
260707|NCT01190891|E2|Reported Event|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL
Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
260745|NCT01190839|E1|Reported Event|Placebo|Participants treated with placebo through the final visit or through a protocol defined dose increase. If a participant had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.
260746|NCT01190813|B3|Baseline|Total|Total of all reporting groups
260708|NCT01190891|E1|Reported Event|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.
Manual Physical Therapy: Same as arm description"
260709|NCT01190878|B5|Baseline|Total|Total of all reporting groups
260710|NCT01190878|B4|Baseline|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
260711|NCT01190878|B3|Baseline|Xibrom BID|Xibrom™: Xibrom dosed BID
260712|NCT01190878|B2|Baseline|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
260713|NCT01190878|B1|Baseline|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
260714|NCT01190878|P4|Participant Flow|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle dosed BID
260715|NCT01190878|P3|Participant Flow|Xibrom BID|Xibrom™: 0.09% bromfenac dosed BID
260716|NCT01190878|P2|Participant Flow|ISV-303 QD|ISV-303: 0.075% bromfenac in DuraSite dosed QD
260717|NCT01190878|P1|Participant Flow|ISV-303 BID|ISV-303: 0.075% bromfenac in DuraSite dosed BID
260718|NCT01190878|O4|Outcome|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
260719|NCT01190878|O3|Outcome|Xibrom BID|Xibrom™: Xibrom dosed BID
260720|NCT01190878|O2|Outcome|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
260721|NCT01190878|O1|Outcome|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
260722|NCT01190878|E4|Reported Event|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
260723|NCT01190878|E3|Reported Event|Xibrom BID|Xibrom™: Xibrom dosed BID
260724|NCT01190878|E2|Reported Event|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
260725|NCT01190878|E1|Reported Event|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
260726|NCT01190865|B1|Baseline|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days
HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
260727|NCT01190865|P1|Participant Flow|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days
HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
260728|NCT01190865|O1|Outcome|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days
HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
260729|NCT01190865|O1|Outcome|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days
HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
260730|NCT01190865|E1|Reported Event|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days
HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
260731|NCT01190839|B3|Baseline|Total|Total of all reporting groups
260732|NCT01190839|B2|Baseline|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
260733|NCT01190839|B1|Baseline|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
260734|NCT01190839|P2|Participant Flow|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
260735|NCT01190839|P1|Participant Flow|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
260736|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
260737|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
260738|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
260739|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
260740|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
260741|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
260742|NCT01190839|E4|Reported Event|First Infliximab 5 mg/kg Then Infliximab 10 mg/kg|Participants had a protocol defined dose increase from infliximab 5 mg/kg to infliximab 10 mg/kg. Only safety results after the dose increase were included in this group.
260743|NCT01190839|E3|Reported Event|First Placebo Then Infliximab 5 mg/kg|Participants had a protocol defined dose increase from Placebo to infliximab 5 mg/kg. Only safety results after start of infliximab were included in this group.
260744|NCT01190839|E2|Reported Event|Infliximab 5 mg/kg|Participants treated with Infliximab 5 mg/kg at any time through the final visit or through a protocol defined dose increase. If a participants had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.
260747|NCT01190813|B2|Baseline|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
306106|NCT00196313|P2|Participant Flow|Placebo|Placebo, 1 tablet daily
260750|NCT01190813|P1|Participant Flow|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260751|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260752|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260753|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260754|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260755|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260756|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260757|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260758|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260759|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260760|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260761|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260762|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260763|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260764|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260765|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260766|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260767|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260768|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260769|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260770|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260771|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260772|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260773|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260774|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260775|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260776|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260777|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260778|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260779|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260780|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260781|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260782|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260783|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260784|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260785|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260786|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260787|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260788|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260789|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
261222|NCT01189890|E1|Reported Event|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
260790|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260791|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260792|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260793|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260794|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260795|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260796|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260797|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260798|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260799|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260800|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260801|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260802|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260803|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260804|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260805|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260806|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260807|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260808|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260809|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260810|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260811|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260812|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260813|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260814|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260815|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260816|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260817|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260818|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260819|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260820|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260821|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260822|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260823|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260824|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260825|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260826|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260827|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260828|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260829|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260873|NCT01190514|P2|Participant Flow|DVS SR 50 mg Fed (B) First|DVS SR 50 mg tablet on Day 1 of study period in fed state.
260830|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260831|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260832|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260833|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260834|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260835|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260836|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260837|NCT01190813|E2|Reported Event|Placebo|"Oral placebo tid
Placebo: Oral placebo tid
Patching: Two hours of daily patching"
260838|NCT01190813|E1|Reported Event|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Patching: Two hours of daily patching"
260839|NCT01190566|B3|Baseline|Total|Total of all reporting groups
260840|NCT01190566|B2|Baseline|Non-pCR|The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
260841|NCT01190566|B1|Baseline|Pathologic Complete Responders (pCR)|The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
260842|NCT01190566|P2|Participant Flow|Non-pCR|The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
260843|NCT01190566|P1|Participant Flow|Pathologic Complete Responders (pCR)|The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
260844|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
260845|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
260846|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
260847|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
260848|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
260849|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
260850|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
260851|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
260852|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
260853|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
260854|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
260855|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
260856|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
260857|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
260858|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
260859|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
260860|NCT01190566|O1|Outcome|Pathologic Response to Chemotherapy|Degree of pathologic response to the neoadjuvant chemotherapy
260861|NCT01190566|E2|Reported Event|Non-pCR|the presence of invasive tumor cells after surgery
260862|NCT01190566|E1|Reported Event|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
260863|NCT01190527|B1|Baseline|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
260864|NCT01190527|P1|Participant Flow|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
260865|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
260866|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
260867|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
260868|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
260869|NCT01190527|E1|Reported Event|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
260870|NCT01190514|B1|Baseline|Entire Study Population|Participants randomized to 1 of the 4 treatment sequences beginning with DVS SR 25 mg*2 Fed (A); or DVS SR 50 mg Fed (B); or DVS SR 25 mg*2 Fasted (C); or DVS SR 50 mg Fasted (D).
260871|NCT01190514|P4|Participant Flow|DVS SR 50 mg Fasted (D) First|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
260872|NCT01190514|P3|Participant Flow|DVS SR 25 mg*2 Fasted (C) First|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
261223|NCT01189812|B3|Baseline|Total|Total of all reporting groups
260874|NCT01190514|P1|Participant Flow|DVS SR 25 mg*2 Fed (A) First|Desvenlafaxine sustained release (DVS SR) formulation (PF-0212375) 25 milligrams (mg) as 2 tablets (25 mg*2) on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
260875|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
260876|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
260877|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
260878|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
260879|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
260880|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
260881|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
260882|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
260883|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
260884|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
260885|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
260886|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
260887|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
260888|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
260889|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
260890|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
260891|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
260892|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
260893|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
260894|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
260895|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
260896|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
260897|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
260898|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
260899|NCT01190514|E4|Reported Event|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
260900|NCT01190514|E3|Reported Event|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
260901|NCT01190514|E2|Reported Event|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
260902|NCT01190514|E1|Reported Event|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
260903|NCT01190436|B1|Baseline|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260904|NCT01190436|P1|Participant Flow|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260905|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.
260906|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260907|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260908|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260909|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260910|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260911|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260912|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260973|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260913|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260914|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260915|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
260916|NCT01190436|E1|Reported Event|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.
260917|NCT01190306|B3|Baseline|Total|Total of all reporting groups
260918|NCT01190306|B2|Baseline|Sham Control|Eyes in the control group will be treated with riboflavin only.
260919|NCT01190306|B1|Baseline|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
260920|NCT01190306|P2|Participant Flow|Sham Control|Eyes in the control group will be treated with riboflavin only.
260921|NCT01190306|P1|Participant Flow|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
260922|NCT01190306|O2|Outcome|Sham Control|Eyes in the control group will be treated with riboflavin only.
260923|NCT01190306|O1|Outcome|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
260924|NCT01190306|E2|Reported Event|Sham Control|Eyes in the control group will be treated with riboflavin only.
260925|NCT01190306|E1|Reported Event|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
260926|NCT01190267|B3|Baseline|Total|Total of all reporting groups
260927|NCT01190267|B2|Baseline|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
260928|NCT01190267|B1|Baseline|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
260929|NCT01190267|P2|Participant Flow|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
260930|NCT01190267|P1|Participant Flow|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
260931|NCT01190267|O2|Outcome|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
260932|NCT01190267|O1|Outcome|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
260933|NCT01190267|O2|Outcome|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
260934|NCT01190267|O1|Outcome|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
260935|NCT01190267|E2|Reported Event|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
260971|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260936|NCT01190267|E1|Reported Event|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
260937|NCT01190254|B4|Baseline|Total|Total of all reporting groups
260938|NCT01190254|B3|Baseline|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260939|NCT01190254|B2|Baseline|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260940|NCT01190254|B1|Baseline|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260941|NCT01190254|P3|Participant Flow|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260942|NCT01190254|P2|Participant Flow|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260943|NCT01190254|P1|Participant Flow|Placebo|Participants receive placebo asenapine tablets sublingually twice daily (BID) for 8 weeks
260944|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260945|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260946|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260947|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260948|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260949|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260950|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260951|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260952|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260953|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260954|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260955|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260956|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260957|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260958|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260959|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260960|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260961|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260962|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260963|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260964|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260965|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260966|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260967|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260968|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260969|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260970|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260974|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260975|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260976|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260977|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260978|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260979|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260980|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260981|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260982|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260983|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260984|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260985|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260986|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260987|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260988|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260989|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260990|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260991|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260992|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260993|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260994|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260995|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260996|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
260997|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
260998|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
260999|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
261000|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
261001|NCT01190254|E3|Reported Event|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
261002|NCT01190254|E2|Reported Event|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
261003|NCT01190254|E1|Reported Event|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
261004|NCT01190215|B3|Baseline|Total|Total of all reporting groups
261005|NCT01190215|B2|Baseline|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261006|NCT01190215|B1|Baseline|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261007|NCT01190215|P2|Participant Flow|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261086|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
261008|NCT01190215|P1|Participant Flow|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261009|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261010|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261011|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261012|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261013|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261014|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261015|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261016|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261017|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261018|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261019|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261020|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261021|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261022|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261023|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261024|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261025|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261026|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261027|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261028|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261029|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261030|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261031|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261087|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
261032|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261033|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261034|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261035|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261036|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261037|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261038|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261039|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261040|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261041|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261042|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261043|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261044|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261045|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261046|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261047|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261048|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261049|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261050|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261051|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261052|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261053|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261054|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261055|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261088|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
261056|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261057|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261058|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261059|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261060|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261061|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261062|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261063|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261064|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261065|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261066|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261067|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261068|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261069|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261070|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261071|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261072|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261073|NCT01190215|E2|Reported Event|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261074|NCT01190215|E1|Reported Event|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
261075|NCT01190150|B3|Baseline|Total|Total of all reporting groups
261076|NCT01190150|B2|Baseline|1.3 g / 0.65 g Tranexamic Acid|Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
261077|NCT01190150|B1|Baseline|0.65 g / 1.3 g Tranexamic Acid|Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
261078|NCT01190150|P2|Participant Flow|1.3 g / 0.65 g Tranexamic Acid|Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
261079|NCT01190150|P1|Participant Flow|0.65 g / 1.3 g Tranexamic Acid|Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
261080|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
261081|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
261082|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
261083|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
261084|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
261085|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
261089|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
261090|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
261091|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
261092|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
261093|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
261094|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
261095|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
261096|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
261097|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
261098|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
261099|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
261100|NCT01190150|E2|Reported Event|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
261101|NCT01190150|E1|Reported Event|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
261102|NCT01190124|B4|Baseline|Total|Total of all reporting groups
261103|NCT01190124|B3|Baseline|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
261104|NCT01190124|B2|Baseline|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
261105|NCT01190124|B1|Baseline|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
261106|NCT01190124|P3|Participant Flow|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
261107|NCT01190124|P2|Participant Flow|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
261108|NCT01190124|P1|Participant Flow|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
261109|NCT01190124|O1|Outcome|Total|Total number of patients studied
261110|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
261111|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
261112|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
261113|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
261114|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
261115|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
261116|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
261117|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
261118|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
261119|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
261120|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
261121|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
261122|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
261123|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
261124|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
261125|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
261126|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
261127|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
261128|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
261129|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
261130|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
261215|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
261131|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
261132|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
261133|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
261134|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
261135|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
261136|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
261137|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
261138|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
261139|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
261140|NCT01190124|E3|Reported Event|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
261141|NCT01190124|E2|Reported Event|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
261142|NCT01190124|E1|Reported Event|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
261143|NCT01190098|B3|Baseline|Total|Total of all reporting groups
261144|NCT01190098|B2|Baseline|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
261145|NCT01190098|B1|Baseline|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
261146|NCT01190098|P2|Participant Flow|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
261147|NCT01190098|P1|Participant Flow|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
261148|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
261149|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
261150|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
261151|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
261152|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
261153|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
261154|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
261155|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
261156|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
261157|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
261158|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
261159|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
261160|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
261161|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
261162|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
261163|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
261164|NCT01190098|E2|Reported Event|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
261216|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
261165|NCT01190098|E1|Reported Event|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
261166|NCT01190085|B4|Baseline|Total|Total of all reporting groups
261167|NCT01190085|B3|Baseline|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261168|NCT01190085|B2|Baseline|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261169|NCT01190085|B1|Baseline|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261170|NCT01190085|P3|Participant Flow|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261171|NCT01190085|P2|Participant Flow|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261172|NCT01190085|P1|Participant Flow|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261173|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261174|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261175|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261176|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261177|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261178|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261179|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261180|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261181|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261182|NCT01190085|E3|Reported Event|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261183|NCT01190085|E2|Reported Event|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261184|NCT01190085|E1|Reported Event|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
261185|NCT01190007|B1|Baseline|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261186|NCT01190007|P1|Participant Flow|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261187|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261188|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261189|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261217|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
261190|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261191|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261192|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261193|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261194|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261195|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261196|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261197|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261198|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261199|NCT01190007|E1|Reported Event|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
261200|NCT01189890|B3|Baseline|Total|Total of all reporting groups
261201|NCT01189890|B2|Baseline|Glimepiride|Glimepiride 1-6 mg QD
261202|NCT01189890|B1|Baseline|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
261203|NCT01189890|P2|Participant Flow|Glimepiride|Glimepiride 1-6 mg QD
261204|NCT01189890|P1|Participant Flow|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
261205|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
261206|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
261207|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
261208|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
261209|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
261210|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
261211|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
261212|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
261213|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
261214|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
261224|NCT01189812|B2|Baseline|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
261225|NCT01189812|B1|Baseline|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
261226|NCT01189812|P2|Participant Flow|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
261227|NCT01189812|P1|Participant Flow|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
261228|NCT01189812|O2|Outcome|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
261229|NCT01189812|O1|Outcome|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
261230|NCT01189812|E2|Reported Event|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
261231|NCT01189812|E1|Reported Event|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
261232|NCT01189760|B4|Baseline|Total|Total of all reporting groups
261233|NCT01189760|B3|Baseline|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261234|NCT01189760|B2|Baseline|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261235|NCT01189760|B1|Baseline|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261236|NCT01189760|P3|Participant Flow|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261237|NCT01189760|P2|Participant Flow|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261238|NCT01189760|P1|Participant Flow|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261239|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261240|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261241|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261242|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261243|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261244|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261245|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261246|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261247|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261248|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261249|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261250|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261251|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261252|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261253|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
307780|NCT00194129|O1|Outcome|Lithium Plus Divalproex|
261254|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261255|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261256|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261257|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261258|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261259|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261260|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261261|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261262|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261263|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261264|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261265|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261266|NCT01189760|E3|Reported Event|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261267|NCT01189760|E2|Reported Event|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261268|NCT01189760|E1|Reported Event|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
261269|NCT01189747|B3|Baseline|Total|Total of all reporting groups
261270|NCT01189747|B2|Baseline|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261271|NCT01189747|B1|Baseline|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261272|NCT01189747|P2|Participant Flow|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261273|NCT01189747|P1|Participant Flow|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261274|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261275|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261276|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261277|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261278|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261279|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261280|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261281|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261282|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261283|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261284|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261285|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261286|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261287|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261288|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261289|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261290|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261291|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261292|NCT01189747|E2|Reported Event|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
261293|NCT01189747|E1|Reported Event|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
261294|NCT01189617|B3|Baseline|Total|Total of all reporting groups
261295|NCT01189617|B2|Baseline|Female|Female Participants
261296|NCT01189617|B1|Baseline|Male|Male Participants
261297|NCT01189617|P2|Participant Flow|Female|Female Participants
261298|NCT01189617|P1|Participant Flow|Male|Male Participants
261299|NCT01189617|O2|Outcome|Female|Female Participants
261300|NCT01189617|O1|Outcome|Male|Male Participants
261301|NCT01189617|E2|Reported Event|Female|Female Participants
261302|NCT01189617|E1|Reported Event|Male|Male Participants
261303|NCT01189604|B8|Baseline|Total|Total of all reporting groups
261304|NCT01189604|B7|Baseline|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
261305|NCT01189604|B6|Baseline|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
261306|NCT01189604|B5|Baseline|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
261307|NCT01189604|B4|Baseline|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
261308|NCT01189604|B3|Baseline|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
261309|NCT01189604|B2|Baseline|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
261310|NCT01189604|B1|Baseline|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
261311|NCT01189604|P7|Participant Flow|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
261312|NCT01189604|P6|Participant Flow|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
261313|NCT01189604|P5|Participant Flow|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
261314|NCT01189604|P4|Participant Flow|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
261315|NCT01189604|P3|Participant Flow|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
261316|NCT01189604|P2|Participant Flow|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
261317|NCT01189604|P1|Participant Flow|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
261318|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
261319|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
261320|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
261321|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
261322|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
261323|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
261324|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
261325|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
261326|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
261327|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
261328|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
261329|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
261330|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
261331|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
261332|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
261333|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
261334|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
261335|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
261336|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
261337|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
261338|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
261339|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
307781|NCT00194129|E2|Reported Event|Lithium Plus Placebo|
261340|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
261341|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
261342|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
261343|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
261344|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
261345|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
261346|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
261347|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
261348|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
261349|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
261350|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
261351|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
261352|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
261353|NCT01189604|E7|Reported Event|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
261354|NCT01189604|E6|Reported Event|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
261355|NCT01189604|E5|Reported Event|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
261356|NCT01189604|E4|Reported Event|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
261357|NCT01189604|E3|Reported Event|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
261358|NCT01189604|E2|Reported Event|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
261359|NCT01189604|E1|Reported Event|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
261360|NCT01189500|B1|Baseline|Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. DVS SR 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261361|NCT01189500|P1|Participant Flow|Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg|Tamoxifen (TAMOX) 40 milligrams (mg) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261362|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261363|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261364|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261365|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261366|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261367|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261368|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261369|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261370|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261371|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261372|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261373|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261374|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261375|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261376|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261377|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261378|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261379|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261380|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261381|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261382|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261383|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261384|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261385|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261386|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261387|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261388|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261389|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261390|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261391|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261392|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261393|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261394|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261395|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261396|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261397|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261398|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261399|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261400|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261401|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261402|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261403|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261404|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261405|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261406|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261407|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261408|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261409|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261410|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261411|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261478|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
261412|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261413|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261414|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261415|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261416|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261417|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
261418|NCT01189500|E3|Reported Event|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|Tamoxifen 40 mg as a single oral dose coadministered with DVS SR 100 mg as a single oral dose on Period 2 / Day 7.
261419|NCT01189500|E2|Reported Event|DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28.
261420|NCT01189500|E1|Reported Event|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose on Period 1 / Day 1.
261421|NCT01189487|B1|Baseline|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
261422|NCT01189487|P1|Participant Flow|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
261423|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
261424|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
261425|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
261426|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
261427|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
261428|NCT01189487|E1|Reported Event|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
261429|NCT01189461|B1|Baseline|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
261430|NCT01189461|P1|Participant Flow|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
261431|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
261432|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
261433|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
261434|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
261435|NCT01189461|E1|Reported Event|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
261436|NCT01189435|B1|Baseline|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.
erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
261437|NCT01189435|P1|Participant Flow|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.
erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
261438|NCT01189435|O1|Outcome|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.
erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
261439|NCT01189435|E1|Reported Event|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.
erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
261440|NCT01189370|B1|Baseline|Sorafenib|"Sorafenib 400 mg twice daily, 7 days a week
Sorafenib 600 mg twice daily, days 1-5 per week
Sorafenib 800 mg twice daily, days 1-5 per week
Sorafenib 1000 mg twice daily, says 1-5 per week"
261441|NCT01189370|P3|Participant Flow|Cohort 3: 800mg|Participants were administered 800mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
261442|NCT01189370|P2|Participant Flow|Cohort 2: 600 mg|Participants were administered 600mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
261443|NCT01189370|P1|Participant Flow|Cohort 1: 400mg|Participants were administered 400 mg of Sorafenib by mouth twice daily for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
261444|NCT01189370|O1|Outcome|Number of Participants With Disease Progression|Total number of participants that had disease progression while on study. Disease progression based on RECIST criteria.
261445|NCT01189370|O3|Outcome|Cohort 3: 800mg|Participants were administered 800mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
261446|NCT01189370|O2|Outcome|Cohort 2: 600 mg|Participants were administered 600mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
261447|NCT01189370|O1|Outcome|Cohort 1: 400mg|Participants were administered 400 mg of Sorafenib by mouth twice daily for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
261448|NCT01189370|E1|Reported Event|Sorafenib|"Sorafenib 400 mg twice daily, 7 days a week
Sorafenib 600 mg twice daily, days 1-5 per week
Sorafenib 800 mg twice daily, days 1-5 per week"
261449|NCT01189292|B3|Baseline|Total|Total of all reporting groups
261450|NCT01189292|B2|Baseline|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
261451|NCT01189292|B1|Baseline|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
261452|NCT01189292|P2|Participant Flow|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
261453|NCT01189292|P1|Participant Flow|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
261454|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
261455|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
261456|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
261457|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
261458|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
261459|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
261460|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
261461|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
261462|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
261463|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
261464|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
261465|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
261466|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
261467|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
261468|NCT01189292|E2|Reported Event|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
261469|NCT01189292|E1|Reported Event|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
261470|NCT01189279|B4|Baseline|Total|Total of all reporting groups
261471|NCT01189279|B3|Baseline|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
261472|NCT01189279|B2|Baseline|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
261473|NCT01189279|B1|Baseline|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
261474|NCT01189279|P3|Participant Flow|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
261475|NCT01189279|P2|Participant Flow|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
261476|NCT01189279|P1|Participant Flow|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
261477|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
261479|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
261480|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
261481|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
261482|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
261483|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
261484|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
261485|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
261486|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
261487|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
261488|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
261489|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
261490|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
261491|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
261492|NCT01189279|E3|Reported Event|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
261493|NCT01189279|E2|Reported Event|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
261494|NCT01189279|E1|Reported Event|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
261495|NCT01189240|B1|Baseline|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261496|NCT01189240|P3|Participant Flow|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261497|NCT01189240|P2|Participant Flow|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261498|NCT01189240|P1|Participant Flow|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261499|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261500|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261501|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261502|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261546|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261621|NCT01189071|O2|Outcome|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
261503|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261504|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261505|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261506|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261507|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261508|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261509|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261510|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261511|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261512|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261513|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261514|NCT01189240|O1|Outcome|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261547|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
261548|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
307782|NCT00194129|E1|Reported Event|Lithium Plus Divalproex|
261515|NCT01189240|E1|Reported Event|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
261516|NCT01189227|B3|Baseline|Total|Total of all reporting groups
261517|NCT01189227|B2|Baseline|Perioperative Chemotherapy|Perioperative chemotherapy
261518|NCT01189227|B1|Baseline|Postoperative Chemotherapy|Postoperative chemotherapy
261519|NCT01189227|P2|Participant Flow|Arm 2: Perioperative Chemotherapy|Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
261520|NCT01189227|P1|Participant Flow|Arm 1: Postoperative Chemotherapy|Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
261521|NCT01189227|O2|Outcome|Arm 2: Perioperative Chemotherapy|Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
261522|NCT01189227|O1|Outcome|Arm 1: Postoperative Chemotherapy|Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
261523|NCT01189227|E2|Reported Event|Perioperative Chemotherapy|Perioperative chemotherapy
261524|NCT01189227|E1|Reported Event|Postoperative Chemotherapy|Postoperative chemotherapy
261525|NCT01189201|B1|Baseline|Study Overall|"A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were
Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)
Empagliflozin plus linagliptin, individual tablets (fasted)
Empagliflozin plus linagliptin FDC A1 (fed)
Empagliflozin plus linagliptin FDC A3 (fasted)
Drug administrations were separated by a washout period of at least 35 days.
A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment."
261526|NCT01189201|P1|Participant Flow|Study Overall|"A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were
Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)
Empagliflozin plus linagliptin, individual tablets (fasted)
Empagliflozin plus linagliptin FDC A1 (fed)
Empagliflozin plus linagliptin FDC A3 (fasted)
Drug administrations were separated by a washout period of at least 35 days.
A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment."
261527|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
261528|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
261529|NCT01189201|O2|Outcome|Empa Plus Linagliptin Indivdual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
261530|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261531|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
261532|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261533|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
261534|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261535|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
261536|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261537|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
261538|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261539|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
261540|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261541|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
261542|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261543|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
261544|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261545|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
261549|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
261550|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261551|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
261552|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261553|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
261554|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261555|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
261556|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261557|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
261558|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261559|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
261560|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
261561|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
261562|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261563|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
261564|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
261565|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
261566|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261567|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
261568|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261569|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
261570|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261571|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
261572|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261573|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
261574|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261575|NCT01189201|E4|Reported Event|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
261576|NCT01189201|E3|Reported Event|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
261577|NCT01189201|E2|Reported Event|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
261578|NCT01189201|E1|Reported Event|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
261579|NCT01189136|B3|Baseline|Total|Total of all reporting groups
261580|NCT01189136|B2|Baseline|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes
PTNS treatment: Electrical stimulation is received"
261581|NCT01189136|B1|Baseline|Sham Treatment|"No electrical stimulation is actually received
Sham treatment: No electrical stimulation is given"
261582|NCT01189136|P2|Participant Flow|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes
PTNS treatment: Electrical stimulation is received"
261583|NCT01189136|P1|Participant Flow|Sham Treatment|"No electrical stimulation is actually received
Sham treatment: No electrical stimulation is given"
261584|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes
PTNS treatment: Electrical stimulation is received"
261585|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received
Sham treatment: No electrical stimulation is given"
261586|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes
PTNS treatment: Electrical stimulation is received"
261587|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received
Sham treatment: No electrical stimulation is given"
261588|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes
PTNS treatment: Electrical stimulation is received"
261589|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received
Sham treatment: No electrical stimulation is given"
261590|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes
PTNS treatment: Electrical stimulation is received"
261591|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received
Sham treatment: No electrical stimulation is given"
261592|NCT01189136|E2|Reported Event|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes
PTNS treatment: Electrical stimulation is received"
261593|NCT01189136|E1|Reported Event|Sham Treatment|"No electrical stimulation is actually received
Sham treatment: No electrical stimulation is given"
261594|NCT01189123|B3|Baseline|Total|Total of all reporting groups
261595|NCT01189123|B2|Baseline|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur
High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
261596|NCT01189123|B1|Baseline|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)
fluzone by sanofi pasteur: standard dose fluzone"
261597|NCT01189123|P2|Participant Flow|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur
High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
261598|NCT01189123|P1|Participant Flow|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)
fluzone by sanofi pasteur: standard dose fluzone
1 dose of vaccine was given IM"
261599|NCT01189123|O2|Outcome|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur
High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
261600|NCT01189123|O1|Outcome|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)
fluzone by sanofi pasteur: standard dose fluzone"
261601|NCT01189123|O2|Outcome|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur
High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
261602|NCT01189123|O1|Outcome|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)
fluzone by sanofi pasteur: standard dose fluzone"
261603|NCT01189123|E2|Reported Event|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur
High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
261604|NCT01189123|E1|Reported Event|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)
fluzone by sanofi pasteur: standard dose fluzone"
261605|NCT01189110|B3|Baseline|Total|Total of all reporting groups
261606|NCT01189110|B2|Baseline|Arm 2|Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
261607|NCT01189110|B1|Baseline|Arm 1|Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
261608|NCT01189110|P2|Participant Flow|Arm 2|Placebo group- sham Stim Flex machine
261609|NCT01189110|P1|Participant Flow|Arm 1|Intervention- true Stim Flex treatment
261610|NCT01189110|O2|Outcome|Arm 2- Placebo|Receipt of sham auriculotherapy via a Stim Flex machine that disabled electrical flow of current to the ear probe.
261611|NCT01189110|O1|Outcome|Arm 1- Intervention|Receipt of auriculotherapy via a Stim Flex machine that provided full electrical flow of current to the ear probe.
261612|NCT01189110|E2|Reported Event|Arm 2- Placebo|Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
261613|NCT01189110|E1|Reported Event|Arm 1- Intervention|Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
261614|NCT01189071|B3|Baseline|Total|Total of all reporting groups
261615|NCT01189071|B2|Baseline|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
261616|NCT01189071|B1|Baseline|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication
Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
261617|NCT01189071|P2|Participant Flow|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
261618|NCT01189071|P1|Participant Flow|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication
Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
261619|NCT01189071|O2|Outcome|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
261620|NCT01189071|O1|Outcome|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication
Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
261622|NCT01189071|O1|Outcome|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication
Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
261623|NCT01189071|E2|Reported Event|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
261624|NCT01189071|E1|Reported Event|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication
Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
261625|NCT01189032|B4|Baseline|Total|Total of all reporting groups
261626|NCT01189032|B3|Baseline|High Concentration|3% DE-089 ophthalmic solution
261627|NCT01189032|B2|Baseline|Low Concentration|1% DE-089 ophthalmic solution
261628|NCT01189032|B1|Baseline|Placebo|Placebo ophthalmic solution
261629|NCT01189032|P3|Participant Flow|High Concentration|3% DE-089 ophthalmic solution
261630|NCT01189032|P2|Participant Flow|Low Concentration|1% DE-089 ophthalmic solution
261631|NCT01189032|P1|Participant Flow|Placebo|Placebo ophthalmic solution
261632|NCT01189032|O3|Outcome|High Concentration|3% DE-089 ophthalmic solution
261633|NCT01189032|O2|Outcome|Low Concentration|1% DE-089 ophthalmic solution
261634|NCT01189032|O1|Outcome|Placebo|Placebo ophthalmic solution
261635|NCT01189032|E3|Reported Event|High Concentration|3% DE-089 ophthalmic solution
261636|NCT01189032|E2|Reported Event|Low Concentration|1% DE-089 ophthalmic solution
261637|NCT01189032|E1|Reported Event|Placebo|Placebo ophthalmic solution
261638|NCT01188967|B3|Baseline|Total|Total of all reporting groups
261639|NCT01188967|B2|Baseline|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received the active treatment: GSK598809 pills,60 mg/day.
261640|NCT01188967|B1|Baseline|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received placebo pills.
261641|NCT01188967|P2|Participant Flow|Placebo Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
261642|NCT01188967|P1|Participant Flow|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received 60 mg GSK598809 pills, the active treatment, for 6 weeks.
261643|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
261644|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
261645|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
261646|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
261647|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
261648|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
261649|NCT01188967|O2|Outcome|GSK598809 Treatment Group|
261650|NCT01188967|O1|Outcome|Placebo Treatment Group|
261651|NCT01188967|E2|Reported Event|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the GSK598809 pills, the active treatment.
261652|NCT01188967|E1|Reported Event|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the placebo pills.
261653|NCT01188928|B5|Baseline|Total|Total of all reporting groups
261654|NCT01188928|B4|Baseline|Topical Suspension Vehicle|The topical suspension vehicle alone
261655|NCT01188928|B3|Baseline|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
261656|NCT01188928|B2|Baseline|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
261657|NCT01188928|B1|Baseline|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
261658|NCT01188928|P4|Participant Flow|Topical Suspension Vehicle|The topical suspension vehicle alone
261659|NCT01188928|P3|Participant Flow|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
261660|NCT01188928|P2|Participant Flow|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
261661|NCT01188928|P1|Participant Flow|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
261662|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
261663|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
261664|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
261665|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
261666|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
261667|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
261668|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
261669|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
261670|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
261671|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
261672|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
261673|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
261674|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
261675|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
261676|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
261677|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
261678|NCT01188928|E4|Reported Event|Topical Suspension Vehicle|The topical suspension vehicle alone
261679|NCT01188928|E3|Reported Event|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
261680|NCT01188928|E2|Reported Event|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
261681|NCT01188928|E1|Reported Event|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
261682|NCT01188811|B3|Baseline|Total|Total of all reporting groups
261683|NCT01188811|B2|Baseline|Placebo|"28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
261684|NCT01188811|B1|Baseline|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
261685|NCT01188811|P2|Participant Flow|Placebo|"28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
261686|NCT01188811|P1|Participant Flow|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
261687|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
261688|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
261689|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
261690|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
261691|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
261692|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
261693|NCT01188811|E2|Reported Event|Placebo|"28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
261694|NCT01188811|E1|Reported Event|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
261695|NCT01188798|B3|Baseline|Total|Total of all reporting groups
261696|NCT01188798|B2|Baseline|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)
Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
261697|NCT01188798|B1|Baseline|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)
Methotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
261725|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261726|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261698|NCT01188798|P2|Participant Flow|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)
Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
261699|NCT01188798|P1|Participant Flow|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)
Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
261700|NCT01188798|O2|Outcome|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin).
Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
261701|NCT01188798|O1|Outcome|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)
Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
261702|NCT01188798|O2|Outcome|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)
Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
261703|NCT01188798|O1|Outcome|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)
Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
261704|NCT01188798|E2|Reported Event|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)
Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
261705|NCT01188798|E1|Reported Event|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)
Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
261706|NCT01188772|B5|Baseline|Total|Total of all reporting groups
261707|NCT01188772|B4|Baseline|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261708|NCT01188772|B3|Baseline|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261709|NCT01188772|B2|Baseline|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261710|NCT01188772|B1|Baseline|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261711|NCT01188772|P4|Participant Flow|Sofosbuvir 400 mg (Genotype 2/3)|Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks.
261712|NCT01188772|P3|Participant Flow|Placebo (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
261713|NCT01188772|P2|Participant Flow|Sofosbuvir 400 mg (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
261714|NCT01188772|P1|Participant Flow|Sofosbuvir 200 mg (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+pegylated interferon alfa-2a (PEG)+ribavirin (RBV) for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
261715|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261716|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261717|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261718|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261719|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261720|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261721|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261722|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261723|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261724|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261727|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261728|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261729|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261730|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261731|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261732|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261733|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261734|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261735|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
261736|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261737|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261738|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261739|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261740|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261741|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261742|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261743|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261744|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261745|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261746|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261747|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261748|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261749|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261750|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261751|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261752|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261753|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261754|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261755|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261756|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261757|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261758|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261759|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261760|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261761|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261762|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261763|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261764|NCT01188772|E4|Reported Event|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
261765|NCT01188772|E3|Reported Event|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261766|NCT01188772|E2|Reported Event|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261767|NCT01188772|E1|Reported Event|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
261768|NCT01188694|B4|Baseline|Total|Total of all reporting groups
261769|NCT01188694|B3|Baseline|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
261770|NCT01188694|B2|Baseline|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
261771|NCT01188694|B1|Baseline|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
261772|NCT01188694|P3|Participant Flow|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
263319|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
261773|NCT01188694|P2|Participant Flow|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
261774|NCT01188694|P1|Participant Flow|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
261775|NCT01188694|O3|Outcome|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
261776|NCT01188694|O2|Outcome|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
261777|NCT01188694|O1|Outcome|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
261778|NCT01188694|E3|Reported Event|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
261779|NCT01188694|E2|Reported Event|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
261780|NCT01188694|E1|Reported Event|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
261781|NCT01188681|B5|Baseline|Total|Total of all reporting groups
261782|NCT01188681|B4|Baseline|Phase 2: Bendamustine|"Bendamustine alone (70 mg/m2)
Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
261783|NCT01188681|B3|Baseline|Phase 2: TRU-016 and Bendamustine|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)
TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
261784|NCT01188681|B2|Baseline|Phase 1: 20 mg/kg TRU-016|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)
TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
261785|NCT01188681|B1|Baseline|Phase 1: 15 mg/kg TRU-016|"TRU-016 (15 mg/kg) and bendamustine (70 mg/m2)
TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
261786|NCT01188681|P4|Participant Flow|Phase 2 Bendamustine|Patients in the bendamustine arm received bendamustine (70 mg/m2) administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
261787|NCT01188681|P3|Participant Flow|Phase 2 TRU-016 and Bendamustine|Patients in the combination arm received otlertuzumab (20 mg/kg) weekly by IV infusion for two 28-day cycles then every 14 days for four 28-day cycles. In both arms, bendamustine (70 mg/m2) was administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
261788|NCT01188681|P2|Participant Flow|Phase 1 20 mg/kg|TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
261789|NCT01188681|P1|Participant Flow|Phase 1 15 mg/kg|TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
261790|NCT01188681|O4|Outcome|Phase 1: 20 mg/kg TRU-016 +Bendamustine|TRU-016 and bendamustine: TRU-016 (n = 6 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
261791|NCT01188681|O3|Outcome|Phase 1: 15 mg/kg TRU-016 +Beendamustine|TRU-016 and bendamustine: TRU-016 (n = 6 patients), 15 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
261792|NCT01188681|O2|Outcome|Phase 2: Bendamustine|"Bendamustine alone (n = 33 patients) (70 mg/m2)
Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
261793|NCT01188681|O1|Outcome|Phase 2: TRU-016 and Bendamustine|"TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2)
TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
261794|NCT01188681|O4|Outcome|Bendamustine|"Bendamustine alone (n = 33 patients) (70 mg/m2)
Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
261795|NCT01188681|O3|Outcome|TRU-016 and Bendamustine|"TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2)
TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
261796|NCT01188681|O2|Outcome|Phase 1 20 mg/kg TRU-016|20 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group
261797|NCT01188681|O1|Outcome|Phase 1 15 mg/kg TRU-016|15 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group
261798|NCT01188681|E4|Reported Event|Phase 2:Bendamustine|"Bendamustine alone (70 mg/m2)
Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
261799|NCT01188681|E3|Reported Event|Phase 2: TRU-016 and Bendamustine|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)
TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
261800|NCT01188681|E2|Reported Event|Phase 1: 20 mg/kg|TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
263320|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
261801|NCT01188681|E1|Reported Event|Phase 1: 15 mg/kg|TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
261802|NCT01188668|B1|Baseline|Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1. DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261803|NCT01188668|P1|Participant Flow|Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg|Aripiprazole (ARIP) as a single oral dose of 5 milligrams (mg) Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261804|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261805|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261806|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261807|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261808|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261809|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261810|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261811|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261812|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261813|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261814|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261815|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261816|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261817|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261818|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261819|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261820|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261821|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261822|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261823|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261824|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261825|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261826|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261827|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261828|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261829|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261830|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261831|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261832|NCT01188668|E3|Reported Event|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 7 though Day 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
261833|NCT01188668|E2|Reported Event|DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state).
263321|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
261834|NCT01188668|E1|Reported Event|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
261835|NCT01188655|B1|Baseline|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261836|NCT01188655|P1|Participant Flow|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261837|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261838|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261839|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261840|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261841|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261842|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261843|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261844|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261845|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261846|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261847|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261848|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261849|NCT01188655|E1|Reported Event|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
261850|NCT01188603|B1|Baseline|Flibanserin|100mg Flibanserin administered orally once daily
261851|NCT01188603|P1|Participant Flow|Flibanserin|100mg Flibanserin administered orally once daily
261852|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
261853|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
261854|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
261855|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
261856|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
261857|NCT01188603|E1|Reported Event|Flibanserin|100mg Flibanserin administered orally once daily
261858|NCT01188577|B3|Baseline|Total|Total of all reporting groups
261859|NCT01188577|B2|Baseline|T, C|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
261860|NCT01188577|B1|Baseline|C, T|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
261861|NCT01188577|P2|Participant Flow|T, C|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
261862|NCT01188577|P1|Participant Flow|C, T|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
261863|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
261864|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
261865|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
261866|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
261867|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
261868|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
261869|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
261870|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
261871|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
261872|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
261873|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
261874|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
261875|NCT01188577|E2|Reported Event|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
261876|NCT01188577|E1|Reported Event|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
261877|NCT01188564|B3|Baseline|Total|Total of all reporting groups
261878|NCT01188564|B2|Baseline|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
261879|NCT01188564|B1|Baseline|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
261880|NCT01188564|P2|Participant Flow|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
261881|NCT01188564|P1|Participant Flow|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
261882|NCT01188564|O2|Outcome|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
261883|NCT01188564|O1|Outcome|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
261884|NCT01188564|O2|Outcome|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
261885|NCT01188564|O1|Outcome|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
261886|NCT01188564|E2|Reported Event|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
261887|NCT01188564|E1|Reported Event|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
261888|NCT01188551|B5|Baseline|Total|Total of all reporting groups
261889|NCT01188551|B4|Baseline|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
261890|NCT01188551|B3|Baseline|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
261891|NCT01188551|B2|Baseline|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
261892|NCT01188551|B1|Baseline|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
261893|NCT01188551|P4|Participant Flow|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
261894|NCT01188551|P3|Participant Flow|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
261895|NCT01188551|P2|Participant Flow|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
261896|NCT01188551|P1|Participant Flow|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
261897|NCT01188551|O4|Outcome|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
307783|NCT00201448|B3|Baseline|Total|Total of all reporting groups
261898|NCT01188551|O3|Outcome|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
261899|NCT01188551|O2|Outcome|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
261900|NCT01188551|O1|Outcome|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
261901|NCT01188551|O4|Outcome|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
261902|NCT01188551|O3|Outcome|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
261903|NCT01188551|O2|Outcome|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
261904|NCT01188551|O1|Outcome|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
261905|NCT01188551|E4|Reported Event|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
261906|NCT01188551|E3|Reported Event|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
261907|NCT01188551|E2|Reported Event|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
261908|NCT01188551|E1|Reported Event|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
261909|NCT01188538|B3|Baseline|Total|Total of all reporting groups
261910|NCT01188538|B2|Baseline|Benzoyl Peroxide (BPO) Gel|
261911|NCT01188538|B1|Baseline|Epiduo Gel|
261912|NCT01188538|P2|Participant Flow|Benzoyl Peroxide (BPO) Gel|
261913|NCT01188538|P1|Participant Flow|Epiduo Gel|
261914|NCT01188538|O2|Outcome|BPO Gel|BPO Gel Topical to the face, once daily application in the evening
261915|NCT01188538|O1|Outcome|Epiduo® Gel|Epiduo® Gel Topical to the face, once daily application in the evening
261916|NCT01188538|O2|Outcome|Benzoyl Peroxide (BPO) Gel|
261917|NCT01188538|O1|Outcome|Epiduo Gel|
261918|NCT01188538|E2|Reported Event|Benzoyl Peroxide (BPO) Gel|
261919|NCT01188538|E1|Reported Event|Epiduo Gel|
261920|NCT01188499|B6|Baseline|Total|Total of all reporting groups
261921|NCT01188499|B5|Baseline|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
261922|NCT01188499|B4|Baseline|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
261923|NCT01188499|B3|Baseline|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261924|NCT01188499|B2|Baseline|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261925|NCT01188499|B1|Baseline|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261926|NCT01188499|P5|Participant Flow|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
261927|NCT01188499|P4|Participant Flow|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
261928|NCT01188499|P3|Participant Flow|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261929|NCT01188499|P2|Participant Flow|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261930|NCT01188499|P1|Participant Flow|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261981|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
261983|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
261931|NCT01188499|O5|Outcome|Arm 5: Liposomal Doxorubicin|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
261932|NCT01188499|O4|Outcome|Arm 4: Gemcitabine + TL32711|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
261933|NCT01188499|O3|Outcome|Arm 3: Docetaxel + TL32711|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261934|NCT01188499|O2|Outcome|Arm 2: Irinotecan + TL32711|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261935|NCT01188499|O1|Outcome|Arm 1: Carboplatin/Paclitaxel + TL32711|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261936|NCT01188499|O5|Outcome|Arm 5: Liposomal Doxorubicin|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
261937|NCT01188499|O4|Outcome|Arm 4: Gemcitabine + TL32711|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
261938|NCT01188499|O3|Outcome|Arm 3: Docetaxel + TL32711|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261939|NCT01188499|O2|Outcome|Arm 2: Irinotecan + TL32711|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261940|NCT01188499|O1|Outcome|Arm 1: Carboplatin/Paclitaxel + TL32711|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261941|NCT01188499|E5|Reported Event|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
261942|NCT01188499|E4|Reported Event|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
261943|NCT01188499|E3|Reported Event|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261944|NCT01188499|E2|Reported Event|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261945|NCT01188499|E1|Reported Event|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
261946|NCT01188447|B1|Baseline|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.
Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
261982|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
261947|NCT01188447|P1|Participant Flow|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.
Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
261948|NCT01188447|O1|Outcome|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.
Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
261949|NCT01188447|O1|Outcome|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.
Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
261950|NCT01188447|O1|Outcome|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.
Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
261951|NCT01188447|O1|Outcome|Eligible Patients|eligible patients evaluated with the Canadian C-Spine Rule
261952|NCT01188447|O1|Outcome|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.
Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
261953|NCT01188447|E1|Reported Event|Eligible Low-risk Trauma Patients|"Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.
Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."
261954|NCT01188421|B4|Baseline|Total|Total of all reporting groups
261955|NCT01188421|B3|Baseline|Clonidine|"Oral clonidine tablets (or placebo)
Clonidine: up to 0.8 mg per day (oral)"
261956|NCT01188421|B2|Baseline|Tramadol ER|"Oral tramadol tablets (or placebo)
Tramadol ER: up to 600 mg per day"
261957|NCT01188421|B1|Baseline|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)
Buprenorphine/naloxone: up to 8/2 mg SL per day"
261958|NCT01188421|P3|Participant Flow|Clonidine|"Oral clonidine tablets (or placebo)
Clonidine: up to 0.8 mg per day (oral)"
261959|NCT01188421|P2|Participant Flow|Tramadol ER|"Oral tramadol tablets (or placebo)
Tramadol ER: up to 600 mg per day"
261960|NCT01188421|P1|Participant Flow|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)
Buprenorphine/naloxone: up to 8/2 mg SL per day"
261961|NCT01188421|O3|Outcome|Clonidine|"Oral clonidine tablets (or placebo)
Clonidine: up to 0.8 mg per day (oral)"
261962|NCT01188421|O2|Outcome|Tramadol ER|"Oral tramadol tablets (or placebo)
Tramadol ER: up to 600 mg per day"
261963|NCT01188421|O1|Outcome|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)
Buprenorphine/naloxone: up to 8/2 mg SL per day"
261964|NCT01188421|E3|Reported Event|Clonidine|"Oral clonidine tablets (or placebo)
Clonidine: up to 0.8 mg per day (oral)"
261965|NCT01188421|E2|Reported Event|Tramadol ER|"Oral tramadol tablets (or placebo)
Tramadol ER: up to 600 mg per day"
261966|NCT01188421|E1|Reported Event|Buprenorphine|"Sublingual buprenorphine/naloxone tablets (or placebo)
Buprenorphine/naloxone: up to 8/2 mg SL per day"
261967|NCT01188343|B4|Baseline|Total|Total of all reporting groups
261968|NCT01188343|B3|Baseline|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
261969|NCT01188343|B2|Baseline|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
261970|NCT01188343|B1|Baseline|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
261971|NCT01188343|P3|Participant Flow|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE CV vaccine on day 0
261972|NCT01188343|P2|Participant Flow|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
261973|NCT01188343|P1|Participant Flow|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
261974|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
261975|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
261976|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
261977|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
261978|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
261979|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
261980|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
261984|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
261985|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
261986|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
261987|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
261988|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
261989|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
261990|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
261991|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
261992|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
261993|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
261994|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
261995|NCT01188343|E3|Reported Event|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
261996|NCT01188343|E2|Reported Event|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
261997|NCT01188343|E1|Reported Event|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
261998|NCT01188226|B1|Baseline|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
261999|NCT01188226|P1|Participant Flow|Nano Hybrid Composite Denture Teeth|"Denture teeth are made of nano hybrid composite material
Denture teeth: Denture teeth made of nano hybrid composite material"
262000|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262001|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262002|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262003|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262004|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262005|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262006|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262007|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262008|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262009|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262010|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262011|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262012|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262013|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262014|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262015|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262016|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262017|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262018|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
262019|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|"Denture teeth are made of nano hybrid composite material
Denture teeth: Denture teeth made of nano hybrid composite material"
262020|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
262021|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262022|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262023|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262024|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262025|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262026|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
262027|NCT01188226|O1|Outcome|Participants With Nano Hybrid Composite Dentures|Denture teeth are made of nano hybrid composite material
262028|NCT01188226|O2|Outcome|Lower Denture|Participants wearing lower denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
262029|NCT01188226|O1|Outcome|Upper Denture|Participants wearing upper denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
263322|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
262030|NCT01188226|O2|Outcome|Lower Denture|Participants with lower denture in use 18 months after denture completion. Denture teeth are made of nano hybrid composite material
262031|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
262032|NCT01188226|O2|Outcome|Lower Denture|Denture teeth are made of nano hybrid composite material
262033|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
262034|NCT01188226|O2|Outcome|Lower Denture|Denture teeth are made of nano hybrid composite material
262035|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
262036|NCT01188226|E1|Reported Event|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
262037|NCT01188109|B1|Baseline|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
Gemcitabine: Standard of care chemotherapy and dosage
Dose - 1000 mg/m²
Schedule - Days 1 and 15; Q 28 days
Cisplatin: Dose - 50 mg/m²
Schedule - Days 1 and 15; Q 28 days"
262038|NCT01188109|P1|Participant Flow|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
Gemcitabine: Standard of care chemotherapy and dosage
Dose - 1000 mg/m²
Schedule - Days 1 and 15; Q 28 days
Cisplatin: Dose - 50 mg/m²
Schedule - Days 1 and 15; Q 28 days"
262039|NCT01188109|O1|Outcome|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
Gemcitabine: Standard of care chemotherapy and dosage
Dose - 1000 mg/m²
Schedule - Days 1 and 15; Q 28 days
Cisplatin: Dose - 50 mg/m²
Schedule - Days 1 and 15; Q 28 days"
262040|NCT01188109|O1|Outcome|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
Gemcitabine: Standard of care chemotherapy and dosage
Dose - 1000 mg/m²
Schedule - Days 1 and 15; Q 28 days
Cisplatin: Dose - 50 mg/m²
Schedule - Days 1 and 15; Q 28 days"
262041|NCT01188109|E1|Reported Event|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
Gemcitabine: Standard of care chemotherapy and dosage
Dose - 1000 mg/m²
Schedule - Days 1 and 15; Q 28 days
Cisplatin: Dose - 50 mg/m²
Schedule - Days 1 and 15; Q 28 days"
262042|NCT01187953|B3|Baseline|Total|Total of all reporting groups
262043|NCT01187953|B2|Baseline|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.
Prograf (tacrolimus): Administered per current product labeling"
262044|NCT01187953|B1|Baseline|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
262045|NCT01187953|P2|Participant Flow|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.
Prograf (tacrolimus): Administered per current product labeling"
262046|NCT01187953|P1|Participant Flow|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
262047|NCT01187953|O2|Outcome|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.
Prograf (tacrolimus): Administered per current product labeling"
262048|NCT01187953|O1|Outcome|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
262049|NCT01187953|O2|Outcome|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.
Prograf (tacrolimus): Administered per current product labeling"
262050|NCT01187953|O1|Outcome|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
262106|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
262107|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
262051|NCT01187953|E2|Reported Event|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.
Prograf (tacrolimus): Administered per current product labeling"
262052|NCT01187953|E1|Reported Event|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
262053|NCT01187914|B1|Baseline|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
262054|NCT01187914|P1|Participant Flow|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
262055|NCT01187914|O1|Outcome|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
262056|NCT01187914|E1|Reported Event|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
262057|NCT01187901|B3|Baseline|Total|Total of all reporting groups
262058|NCT01187901|B2|Baseline|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
262059|NCT01187901|B1|Baseline|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
262060|NCT01187901|P2|Participant Flow|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
262061|NCT01187901|P1|Participant Flow|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
262062|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
262063|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
262064|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
262065|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
262066|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
262067|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
262068|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
262069|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
262070|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
262071|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
262072|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
262073|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
262074|NCT01187901|E2|Reported Event|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
262075|NCT01187901|E1|Reported Event|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
262076|NCT01187771|B3|Baseline|Total|Total of all reporting groups
262077|NCT01187771|B2|Baseline|Continuous Positive Airway Pressure|
262078|NCT01187771|B1|Baseline|Laparoscopic Gastric Banding|
262079|NCT01187771|P2|Participant Flow|Continuous Positive Airway Pressure|
262080|NCT01187771|P1|Participant Flow|Laparoscopic Gastric Banding|
262081|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
262082|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
262083|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
262084|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
262085|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
262086|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
262087|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
262088|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
262089|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
262090|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
262091|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure: Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
262092|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|Laparoscopic Gastric Banding: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
262093|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|
262094|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|
262095|NCT01187771|O2|Outcome|Continuous Positive Airway Pressure|
262096|NCT01187771|O1|Outcome|Laparoscopic Gastric Banding|
262097|NCT01187771|E2|Reported Event|Continuous Positive Airway Pressure|
262098|NCT01187771|E1|Reported Event|Laparoscopic Gastric Banding|
262099|NCT01187550|B3|Baseline|Total|Total of all reporting groups
262100|NCT01187550|B2|Baseline|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
262101|NCT01187550|B1|Baseline|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
262102|NCT01187550|P2|Participant Flow|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
262103|NCT01187550|P1|Participant Flow|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
262104|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
262105|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
262108|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
262109|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
262110|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
262111|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
262112|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
262113|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
262114|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
262115|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
262116|NCT01187550|E2|Reported Event|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
262117|NCT01187550|E1|Reported Event|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
262118|NCT01187511|B3|Baseline|Total|Total of all reporting groups
262119|NCT01187511|B2|Baseline|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262120|NCT01187511|B1|Baseline|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262121|NCT01187511|P2|Participant Flow|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262122|NCT01187511|P1|Participant Flow|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262123|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262124|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262125|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262126|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262127|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262128|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262129|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262130|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262131|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262132|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262133|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262134|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262135|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262136|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262137|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262138|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262139|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262140|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262141|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262142|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262143|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
307784|NCT00201448|B2|Baseline|Towne CMV Vaccine|
262144|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262145|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262146|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262147|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262148|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262149|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262150|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262151|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262152|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262153|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262154|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262155|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262156|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262157|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262158|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262159|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262160|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262161|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262162|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262163|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262164|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262165|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262166|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262167|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262168|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262169|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262170|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262171|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262172|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262173|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262174|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262175|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262176|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262177|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262178|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262179|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262180|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262181|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262182|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262183|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262184|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262185|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262186|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262187|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262188|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262189|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262190|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262191|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262192|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262193|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262194|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262195|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262196|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262197|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262198|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262199|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262200|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262201|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262202|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262203|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262204|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262205|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262206|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262207|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262208|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262209|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262210|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262211|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262212|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262213|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262214|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262215|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262216|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262217|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262218|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262219|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262220|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262221|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262222|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262223|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262224|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262225|NCT01187511|E2|Reported Event|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
262226|NCT01187511|E1|Reported Event|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
262227|NCT01187498|B3|Baseline|Total|Total of all reporting groups
262228|NCT01187498|B2|Baseline|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262229|NCT01187498|B1|Baseline|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262230|NCT01187498|P2|Participant Flow|Drug Therapy|Individually titrated, extended-release oxybutynin chloride, 5-30mg
262231|NCT01187498|P1|Participant Flow|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262232|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262233|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262234|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262235|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262236|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262237|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262238|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262239|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262240|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262241|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262242|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262243|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262244|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262245|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262246|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262247|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262248|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262249|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262250|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262251|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262252|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262253|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262254|NCT01187498|E2|Reported Event|Drug Therapy|Individually titrated, extended release oxybutynin chloride
262255|NCT01187498|E1|Reported Event|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
262256|NCT01187433|B3|Baseline|Total|Total of all reporting groups
262257|NCT01187433|B2|Baseline|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262258|NCT01187433|B1|Baseline|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262259|NCT01187433|P2|Participant Flow|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262260|NCT01187433|P1|Participant Flow|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262261|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262262|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262263|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262264|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262265|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262266|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
307785|NCT00201448|B1|Baseline|Placebo (Hepatitis A)|
262267|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262268|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262269|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262270|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262271|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262272|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262273|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262274|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262275|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262276|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262277|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262278|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262279|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262280|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262281|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262282|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262283|NCT01187433|E2|Reported Event|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
262284|NCT01187433|E1|Reported Event|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
262285|NCT01187355|B3|Baseline|Total|Total of all reporting groups
262286|NCT01187355|B2|Baseline|Renu Fresh MPS|Multi-purpose contact lens solution
262287|NCT01187355|B1|Baseline|Alcon MPDS|Multi-purpose disinfecting contact lens solution
262288|NCT01187355|P2|Participant Flow|Renu Fresh MPS|Multi-purpose contact lens solution
262289|NCT01187355|P1|Participant Flow|Alcon MPDS|Multi-purpose disinfecting contact lens solution
262290|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
262291|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
262292|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
262293|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
262294|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
262295|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
262296|NCT01187355|E2|Reported Event|Renu Fresh MPS|Multi-purpose contact lens solution
262297|NCT01187355|E1|Reported Event|Alcon MPDS|Multi-purpose disinfecting contact lens solution
262298|NCT01187043|B6|Baseline|Total|Total of all reporting groups
262299|NCT01187043|B5|Baseline|ARM 5|"12 mg proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262300|NCT01187043|B4|Baseline|ARM 4|"9 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262301|NCT01187043|B3|Baseline|ARM 3|"6 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262302|NCT01187043|B2|Baseline|ARM 2|"3 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262303|NCT01187043|B1|Baseline|ARM 1|"1 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262304|NCT01187043|P5|Participant Flow|ARM 5|"12 mg proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262305|NCT01187043|P4|Participant Flow|ARM 4|"9 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262306|NCT01187043|P3|Participant Flow|ARM 3|"6 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262307|NCT01187043|P2|Participant Flow|ARM 2|"3 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262308|NCT01187043|P1|Participant Flow|ARM 1|"1 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262309|NCT01187043|O5|Outcome|ARM 5|"12 mg proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262310|NCT01187043|O4|Outcome|ARM 4|"9 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262311|NCT01187043|O3|Outcome|ARM 3|"6 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262312|NCT01187043|O2|Outcome|ARM 2|"3 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262313|NCT01187043|O1|Outcome|ARM 1|"1 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262314|NCT01187043|E5|Reported Event|ARM 5|"12 mg proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262315|NCT01187043|E4|Reported Event|ARM 4|"9 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262316|NCT01187043|E3|Reported Event|ARM 3|"6 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262317|NCT01187043|E2|Reported Event|ARM 2|"3 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262318|NCT01187043|E1|Reported Event|ARM 1|"1 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
262319|NCT01187017|B1|Baseline|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
262320|NCT01187017|P1|Participant Flow|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
262321|NCT01187017|O1|Outcome|Response Rate at 6 Months|"Hematologic Response of Refractory Severe aplastic anemia (SAA) subjects to fludarabine and cyclophosphamide.
The refractory SAA subjects will receive fludarabine and cyclophosphamide. The blood counts will be evaluated to assess a hematologic response. The hematologic response will be defined as complete, partial or no response. The response will be evaluated at 6 months."
262322|NCT01187017|E1|Reported Event|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
262323|NCT01187004|B3|Baseline|Total|Total of all reporting groups
262324|NCT01187004|B2|Baseline|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
262325|NCT01187004|B1|Baseline|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
262326|NCT01187004|P2|Participant Flow|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
262327|NCT01187004|P1|Participant Flow|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
262328|NCT01187004|O2|Outcome|Control Group|patients who didn't develope ALI. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
262329|NCT01187004|O1|Outcome|ICU-LOS in Patients Developing ALI|Intensive care unit length of stay in patients developing acute lung injury. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
262330|NCT01187004|O1|Outcome|Acute Lung Injury|Patients who developed acute lung injury (ALI) after cardiac surgery and during mechanical ventilation
262331|NCT01187004|E2|Reported Event|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
262332|NCT01187004|E1|Reported Event|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
262333|NCT01186939|B1|Baseline|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
262334|NCT01186939|P1|Participant Flow|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
262335|NCT01186939|O1|Outcome|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
262336|NCT01186939|E1|Reported Event|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
262337|NCT01186848|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.
Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side."
262338|NCT01186848|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.
Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side."
262339|NCT01186848|O2|Outcome|Combination Treatment|Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
262340|NCT01186848|O1|Outcome|1550-nm Erbium-doped Fractionated Laser|1550-nm erbium-doped fractionated laser : Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
262341|NCT01186848|E2|Reported Event|Combination Treatment|Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
262342|NCT01186848|E1|Reported Event|1550-nm Erbium-doped Fractionated Laser|1550-nm erbium-doped fractionated laser : Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
262343|NCT01186796|B3|Baseline|Total|Total of all reporting groups
262344|NCT01186796|B2|Baseline|Saline Group|"Subjects are given 3 consecutive weekly injections of Saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262345|NCT01186796|B1|Baseline|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262346|NCT01186796|P2|Participant Flow|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262347|NCT01186796|P1|Participant Flow|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262348|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262349|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262350|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262351|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262352|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262353|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262354|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
307786|NCT00201448|P2|Participant Flow|Towne CMV Vaccine|
262355|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262356|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262357|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262358|NCT01186796|E2|Reported Event|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262359|NCT01186796|E1|Reported Event|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
262360|NCT01186744|B7|Baseline|Total|Total of all reporting groups
262361|NCT01186744|B6|Baseline|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID or up to 28 weeks in Period C (Double-Blind Re-Treatment)
262362|NCT01186744|B5|Baseline|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262363|NCT01186744|B4|Baseline|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262364|NCT01186744|B3|Baseline|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262365|NCT01186744|B2|Baseline|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262366|NCT01186744|B1|Baseline|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262367|NCT01186744|P6|Participant Flow|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262368|NCT01186744|P5|Participant Flow|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262369|NCT01186744|P4|Participant Flow|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262370|NCT01186744|P3|Participant Flow|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262371|NCT01186744|P2|Participant Flow|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for up to 24 continuous weeks during Period A (Initial Treatment)
262372|NCT01186744|P1|Participant Flow|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for up to 24 continuous weeks during Period A (Initial Treatment)
262373|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262374|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262375|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262376|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262377|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262378|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262379|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262380|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262381|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262382|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262383|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262384|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262385|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262386|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262387|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262388|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262389|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262390|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262391|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262392|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262393|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262394|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262395|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262396|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262450|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262397|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262398|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262399|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262400|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262401|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262402|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262403|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262404|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262405|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262406|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262407|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262408|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262409|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262410|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262411|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262412|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262413|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262414|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262415|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262416|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262417|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262418|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262419|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262420|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262421|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262422|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
307787|NCT00201448|P1|Participant Flow|Placebo (Hepatitis A)|
262423|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262424|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262425|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262426|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262427|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262428|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262429|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262430|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262431|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262432|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262433|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262434|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262435|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262436|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262437|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262438|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262439|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262440|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262441|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262442|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262443|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262444|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262445|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262446|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262447|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262448|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262449|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262451|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262452|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262453|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262454|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262455|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262456|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262457|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262458|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262459|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262460|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262461|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262462|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262463|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262464|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262465|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262466|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262467|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262468|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262469|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262470|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262471|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262472|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262473|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262474|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262475|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262476|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262477|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262478|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262479|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262480|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262481|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262482|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262483|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262484|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262485|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262486|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262487|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262488|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262489|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262490|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262491|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262492|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262493|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262494|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262495|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262496|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262497|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262498|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262499|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262500|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262501|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262502|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262503|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
312396|NCT00235326|O2|Outcome|Exposed to Gastroenteritis|
262504|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262505|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262506|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262507|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262508|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262509|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262510|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262511|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262512|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262513|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262514|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262515|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262516|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262517|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262518|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262519|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262520|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262521|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262522|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262523|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262524|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262525|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262526|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262527|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262528|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262529|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262530|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262531|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262532|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262533|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262534|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262535|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262536|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262537|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262538|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262539|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262540|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262541|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262542|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262543|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262544|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262545|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262546|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262547|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262548|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262549|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262550|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262551|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262552|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262553|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262554|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262555|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262556|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262761|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262557|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262558|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262559|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262560|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262561|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262562|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262563|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262564|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262565|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262566|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262567|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262568|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262569|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262570|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262571|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262572|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262573|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262574|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262575|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262576|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262577|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262578|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262579|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262580|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262581|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262582|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
312397|NCT00235326|O1|Outcome|Unexposed to Gastroenteritis|
262583|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262584|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262585|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262586|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262587|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262588|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262589|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262590|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262591|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262592|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262593|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262594|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262595|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262596|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262597|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262598|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262599|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262600|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262601|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262602|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262603|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262604|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262605|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262606|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262607|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262762|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262608|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262609|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262610|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262611|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262612|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262613|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262614|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262615|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262616|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262617|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262618|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262619|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262620|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262621|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262622|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262623|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment)
262624|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262625|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262626|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262627|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262628|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262629|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262630|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262631|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262632|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262633|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment)
262634|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262763|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262635|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262636|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262637|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262638|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262639|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262640|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262641|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262642|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262643|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262644|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262645|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262646|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262647|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262648|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262649|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262650|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262651|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262652|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262653|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262654|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262655|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262656|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262657|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262658|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262659|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262764|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262660|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262661|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262662|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262663|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262664|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262665|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262666|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262667|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262668|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262669|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262670|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262671|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262672|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262673|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262674|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262675|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262676|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262677|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262678|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262679|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262680|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262681|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262682|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262683|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262684|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262685|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
263071|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
262686|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262687|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262688|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262689|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262690|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262691|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262692|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262693|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262694|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262695|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262696|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262697|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262698|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262699|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262700|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262701|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262702|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262703|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262704|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262705|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262706|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262707|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262708|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262709|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262710|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262864|NCT01185964|B3|Baseline|Phase 2: Doxorubicin|"All cycles are 21 days.
Cycles 1-8: doxorubicin 75 mg/m2 on day 1
At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
262711|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262712|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262713|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262714|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262715|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262716|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262717|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262718|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262719|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262720|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262721|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262722|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262723|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262724|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262725|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262726|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262727|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262728|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262729|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262730|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262731|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262732|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262733|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262734|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
263007|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
262735|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262736|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262737|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262738|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262739|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262740|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262741|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262742|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262743|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262744|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262745|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262746|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262747|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262748|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262749|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262750|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262751|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262752|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262753|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262754|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262755|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262756|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262757|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262758|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262759|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262760|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262765|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262766|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262767|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262768|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262769|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262770|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262771|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262772|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262773|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262774|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262775|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262776|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262777|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262778|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262779|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262780|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP690-550 5 mg for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
262781|NCT01186744|E6|Reported Event|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262782|NCT01186744|E5|Reported Event|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262783|NCT01186744|E4|Reported Event|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262784|NCT01186744|E3|Reported Event|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
262785|NCT01186744|E2|Reported Event|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
262786|NCT01186744|E1|Reported Event|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
262787|NCT01186705|B1|Baseline|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.
MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
262867|NCT01185964|P4|Participant Flow|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
262788|NCT01186705|P1|Participant Flow|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.
MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
262789|NCT01186705|O1|Outcome|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.
MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
262790|NCT01186705|E1|Reported Event|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.
MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
262791|NCT01186692|B1|Baseline|Enrolled Cohort|All subjects enrolled.
262792|NCT01186692|P1|Participant Flow|Enrolled|All subjects enrolled (n=131)
262793|NCT01186692|O1|Outcome|Implanted > 24 Hours Cohort|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
262794|NCT01186692|O1|Outcome|Implanted Cohort|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
262795|NCT01186692|O1|Outcome|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
262796|NCT01186692|O1|Outcome|Attempted Implant Cohort|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).
262797|NCT01186692|O1|Outcome|Implanted >24 Hours Cohort|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
262798|NCT01186692|E1|Reported Event|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
262799|NCT01186562|B3|Baseline|Total|Total of all reporting groups
262800|NCT01186562|B2|Baseline|Placebo|Placebo: Placebo
262801|NCT01186562|B1|Baseline|Sitagliptin|Sitagliptin: 100 mg PO daily
262802|NCT01186562|P2|Participant Flow|Placebo|Placebo: Placebo
262803|NCT01186562|P1|Participant Flow|Sitagliptin|Sitagliptin: 100 mg PO daily
262804|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
262805|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
262806|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
262807|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
262808|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
262809|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
262810|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
262811|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
262812|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
262813|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
262814|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
262815|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
262816|NCT01186562|E2|Reported Event|Placebo|Placebo: Placebo
262817|NCT01186562|E1|Reported Event|Sitagliptin|Sitagliptin: 100 mg PO daily
262818|NCT01186458|B1|Baseline|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
262819|NCT01186458|P1|Participant Flow|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
262820|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
262821|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
262822|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
262823|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
262868|NCT01185964|P3|Participant Flow|Phase 2: Doxorubicin|"All cycles are 21 days.
Cycles 1-8: doxorubicin 75 mg/m2 on day 1
At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
262824|NCT01186458|E1|Reported Event|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab
Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
262825|NCT01186419|B3|Baseline|Total|Total of all reporting groups
262826|NCT01186419|B2|Baseline|SPD602 32 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
262827|NCT01186419|B1|Baseline|SPD602 16 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
262828|NCT01186419|P2|Participant Flow|SPD602 32 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
262829|NCT01186419|P1|Participant Flow|SPD602 16 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
262830|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
262831|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
262832|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
262833|NCT01186419|E2|Reported Event|SPD602 32 mg/kg/d|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
262834|NCT01186419|E1|Reported Event|SPD602 16 mg/kg/d|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
262835|NCT01186406|B1|Baseline|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
262836|NCT01186406|P1|Participant Flow|Gliadel, Radiation Therapy, Avastin, Temodar|"Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation
Gliadel, Radiation Therapy, Avastin, Temodar: Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, they will be treated with standard radiation therapy, and daily Temodar (75mg/m2) for 6.5 weeks of radiation. In addition, Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively.
Beginning 2-3 weeks after the last radiation therapy, but not greater than 8 weeks, patients will be treated with Avastin (10 mg/kg) every 14 days along with 5 day Temodar (200 mg/ m2)."
262837|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
262865|NCT01185964|B2|Baseline|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
262866|NCT01185964|B1|Baseline|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
263323|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
262838|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
262839|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
262840|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
262841|NCT01186406|E1|Reported Event|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
262842|NCT01186250|B3|Baseline|Total|Total of all reporting groups
262843|NCT01186250|B2|Baseline|Placebo|"Placebo
Placebo: placebo taken daily for one year"
262844|NCT01186250|B1|Baseline|Pioglitazone|"Pioglitazone
Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
262845|NCT01186250|P2|Participant Flow|Placebo|"Placebo
Placebo: placebo taken daily for one year"
262846|NCT01186250|P1|Participant Flow|Pioglitazone|"Pioglitazone
Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
262847|NCT01186250|O2|Outcome|Placebo|"Placebo
Placebo: placebo taken daily for one year"
262848|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone
Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
262849|NCT01186250|O2|Outcome|Placebo|"Placebo
Placebo: placebo taken daily for one year"
262850|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone
Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
262851|NCT01186250|O2|Outcome|Placebo|"Placebo
Placebo: placebo taken daily for one year"
262852|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone
Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
262853|NCT01186250|O2|Outcome|Placebo|"Placebo
Placebo: placebo taken daily for one year"
262854|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone
Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
262855|NCT01186250|O2|Outcome|Placebo|"Placebo
Placebo: placebo taken daily for one year"
262856|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone
Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
262857|NCT01186250|O2|Outcome|Placebo|"Placebo
Placebo: placebo taken daily for one year"
262858|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone
Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
262859|NCT01186250|O2|Outcome|Placebo|"Placebo
Placebo: placebo taken daily for one year"
262860|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone
Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
262861|NCT01186250|E2|Reported Event|Placebo|"Placebo
Placebo: placebo taken daily for one year"
262862|NCT01186250|E1|Reported Event|Pioglitazone|"Pioglitazone
Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
262863|NCT01185964|B4|Baseline|Total|Total of all reporting groups
262869|NCT01185964|P2|Participant Flow|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
262870|NCT01185964|P1|Participant Flow|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
262871|NCT01185964|O3|Outcome|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
262872|NCT01185964|O2|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
262873|NCT01185964|O1|Outcome|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
262874|NCT01185964|O1|Outcome|Phase 1b and Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
262875|NCT01185964|O1|Outcome|Phase 1b and Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
262876|NCT01185964|O1|Outcome|Phase 1b and Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
262877|NCT01185964|O1|Outcome|Phase 1b and Phase 2 Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
262878|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.
Cycles 1-8: doxorubicin 75 mg/m2 on day 1
At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
262879|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
262880|NCT01185964|O3|Outcome|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
262881|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.
Cycles 1-8: doxorubicin 75 mg/m2 on day 1
At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
262882|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
262883|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.
Cycles 1-8: doxorubicin 75 mg/m2 on day 1
At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
262884|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
262885|NCT01185964|O3|Outcome|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
262886|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.
Cycles 1-8: doxorubicin 75 mg/m2 on day 1
At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
262887|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle."
262888|NCT01185964|O1|Outcome|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1
All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8
Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle
Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle."
262889|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.
Cycles 1-8: doxorubicin 75 mg/m2 on day 1
At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
262890|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1
All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8
Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle
Doxorubicin 75 mg/m2 by IV on day 1 of the 21-day cycle."
262891|NCT01185964|E4|Reported Event|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
262892|NCT01185964|E3|Reported Event|Phase 2: Doxorubicin|"All cycles are 21 days.
Cycles 1-8: doxorubicin 75 mg/m2 on day 1
At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
262893|NCT01185964|E2|Reported Event|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
262894|NCT01185964|E1|Reported Event|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.
Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1
All subsequent cycles until progression:
Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
263324|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
262895|NCT01185834|B1|Baseline|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
262896|NCT01185834|P1|Participant Flow|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
262897|NCT01185834|O1|Outcome|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
262898|NCT01185834|O1|Outcome|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
262899|NCT01185834|E1|Reported Event|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
262900|NCT01185782|B3|Baseline|Total|Total of all reporting groups
262901|NCT01185782|B2|Baseline|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262902|NCT01185782|B1|Baseline|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262903|NCT01185782|P2|Participant Flow|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262904|NCT01185782|P1|Participant Flow|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262905|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262906|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262907|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262908|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262909|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262910|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262911|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262912|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262913|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262914|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262915|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262916|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
263008|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
262917|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262918|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262919|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262920|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262921|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262922|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262923|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262924|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262925|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262926|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262927|NCT01185782|E2|Reported Event|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262928|NCT01185782|E1|Reported Event|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
262929|NCT01185704|B3|Baseline|Total|Total of all reporting groups
262930|NCT01185704|B2|Baseline|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262931|NCT01185704|B1|Baseline|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262932|NCT01185704|P2|Participant Flow|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262933|NCT01185704|P1|Participant Flow|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262934|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262935|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
263009|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
262936|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262937|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262938|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262939|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262940|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262941|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262942|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262943|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262944|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262945|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262946|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262947|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262948|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262949|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262950|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262967|NCT01185600|B2|Baseline|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
312398|NCT00235391|B7|Baseline|Total|Total of all reporting groups
262951|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262952|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262953|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262954|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262955|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262956|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262957|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262958|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262959|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262960|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262961|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262962|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262963|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262964|NCT01185704|E2|Reported Event|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262965|NCT01185704|E1|Reported Event|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
262966|NCT01185600|B3|Baseline|Total|Total of all reporting groups
263072|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
262968|NCT01185600|B1|Baseline|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
262969|NCT01185600|P2|Participant Flow|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
262970|NCT01185600|P1|Participant Flow|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
262971|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
262972|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
262973|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
262974|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
262975|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
262976|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
262977|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
262978|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
262979|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
262980|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
262981|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
262982|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
262983|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
262984|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency,or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
262985|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
262986|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
263006|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
262987|NCT01185600|E2|Reported Event|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
262988|NCT01185600|E1|Reported Event|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
262989|NCT01185561|B3|Baseline|Total|Total of all reporting groups
262990|NCT01185561|B2|Baseline|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
262991|NCT01185561|B1|Baseline|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
262992|NCT01185561|P2|Participant Flow|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
262993|NCT01185561|P1|Participant Flow|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
262994|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
262995|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
262996|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
262997|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
262998|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
262999|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
263000|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
263001|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
263002|NCT01185561|E2|Reported Event|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
263003|NCT01185561|E1|Reported Event|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
263004|NCT01185522|B1|Baseline|Tocilizumab|Participants who received tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263005|NCT01185522|P1|Participant Flow|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263010|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263011|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263012|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263013|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263014|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263015|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263016|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263017|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263018|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263019|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263020|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263021|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263022|NCT01185522|O1|Outcome|Tocilizumab|Participants who received tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263023|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263024|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263025|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263026|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263027|NCT01185522|E1|Reported Event|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
263028|NCT01185509|B3|Baseline|Total|Total of all reporting groups
263029|NCT01185509|B2|Baseline|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263030|NCT01185509|B1|Baseline|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263031|NCT01185509|P2|Participant Flow|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263032|NCT01185509|P1|Participant Flow|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263068|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B.
MTX was administered orally as background therapy."
263033|NCT01185509|O2|Outcome|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263034|NCT01185509|O1|Outcome|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263035|NCT01185509|O2|Outcome|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263036|NCT01185509|O1|Outcome|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263037|NCT01185509|O2|Outcome|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263038|NCT01185509|O1|Outcome|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263039|NCT01185509|E2|Reported Event|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263040|NCT01185509|E1|Reported Event|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
263041|NCT01185353|B6|Baseline|Total|Total of all reporting groups
263042|NCT01185353|B5|Baseline|Placebo|"Placebo administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.
MTX was administered orally as background therapy."
263069|NCT01185353|O1|Outcome|1 mg LY3009104|1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
312785|NCT00236184|P2|Participant Flow|Rabeprazole 10 mg|
263043|NCT01185353|B4|Baseline|8 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.
MTX was administered orally as background therapy."
263044|NCT01185353|B3|Baseline|4 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.
MTX was administered orally as background therapy."
263045|NCT01185353|B2|Baseline|2 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.
MTX was administered orally as background therapy."
263046|NCT01185353|B1|Baseline|1 mg LY3009104|"Administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.
MTX was administered orally as background therapy."
263047|NCT01185353|P10|Participant Flow|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Participants who received 8 mg LY3009104 QD in Part B remained on 8 mg LY3009104 QD in Part C.
Participants who completed Part C received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263048|NCT01185353|P9|Participant Flow|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.
Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.
At Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥ 6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Participants who completed Part C received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263049|NCT01185353|P8|Participant Flow|4 mg LY3009104 QD - Parts C and D|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.
Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.
Participants who completed Part C continued to receive 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263050|NCT01185353|P7|Participant Flow|4 mg LY3009104 QD - Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.
MTX was administered orally as background therapy."
263051|NCT01185353|P6|Participant Flow|2 mg LY3009104 BID - Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 twice daily (BID) in Part B.
MTX was administered orally as background therapy."
263052|NCT01185353|P5|Participant Flow|Placebo QD - Part A|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263053|NCT01185353|P4|Participant Flow|8 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263054|NCT01185353|P3|Participant Flow|4 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263055|NCT01185353|P2|Participant Flow|2 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263056|NCT01185353|P1|Participant Flow|1 Milligrams (mg) LY3009104 QD - Part A|"Administered orally once daily (QD) for 12 weeks in Part A.
Methotrexate (MTX) was administered orally as background therapy."
263057|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263058|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263059|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263060|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263061|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263062|NCT01185353|O4|Outcome|8 mg LY3009104|8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
263063|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.
MTX was administered orally as background therapy."
263064|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B.
MTX was administered orally as background therapy."
263065|NCT01185353|O1|Outcome|1mg LY3009104|1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
263066|NCT01185353|O4|Outcome|8 mg LY3009104|8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
263067|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.
MTX was administered orally as background therapy."
263070|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263073|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263074|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263075|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263076|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263077|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263078|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263079|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263080|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263081|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263082|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263083|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263084|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263085|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263086|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263087|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263088|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263089|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263090|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263091|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263092|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263093|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263094|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263095|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263096|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263097|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263098|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263099|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥ 6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263100|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263101|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263102|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263103|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263104|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263105|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263106|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263135|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
312786|NCT00236184|P1|Participant Flow|Placebo|
263107|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263108|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263109|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263110|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263111|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263112|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263113|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263114|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263115|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263116|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263117|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263118|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263119|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263120|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263121|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263122|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263123|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263124|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263125|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263126|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263127|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263128|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263129|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263130|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263131|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263132|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263133|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263134|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263136|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263137|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263138|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263139|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263140|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263141|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263142|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263143|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263144|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263145|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263146|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263147|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263148|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263149|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263150|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263151|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263152|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263153|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263154|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263155|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263156|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263157|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263158|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263159|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263160|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263161|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263162|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263163|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263164|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263165|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263166|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263167|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263168|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263169|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263170|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263171|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263172|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263173|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263174|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263175|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263176|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263177|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263178|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263179|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263180|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263181|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.
Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263182|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.
Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.
Received 4 mg LY3009104 QD in Part C.
Received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263183|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263184|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263185|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263186|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.
MTX was administered orally as background therapy."
263187|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263188|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263189|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263190|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263191|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263192|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263193|NCT01185353|O2|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263194|NCT01185353|O1|Outcome|4 or 8 mg LY3009104|"4 or 8 mg LY3009104 administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263195|NCT01185353|E18|Reported Event|Follow-Up|"Up to 28 days post the last dose of study drug.
MTX was administered orally as background therapy."
263196|NCT01185353|E17|Reported Event|8/4 mg LY3009104 QD - Part D|"Participants who received 8 mg LY3009104 QD in Part C received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263197|NCT01185353|E16|Reported Event|4 mg LY3009104 QD (4 to 8 mg Rescue)- Part D|"Participants who received 8 mg LY3009104 QD rescue treatment in Part C received 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263198|NCT01185353|E15|Reported Event|4 mg LY3009104 QD - Part D|"Participants who received 4 mg LY3009104 QD in Part C continued to receive 4 mg LY3009104 QD in Part D.
MTX was administered orally as background therapy."
263199|NCT01185353|E14|Reported Event|8 mg LY3009104 QD - Part C|"Participants who received 8 mg LY3009104 QD in Part B remained on 8 mg LY3009104 QD in Part C.
MTX was administered orally as background therapy."
263233|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263273|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263200|NCT01185353|E13|Reported Event|4 to 8 mg LY3009104 QD Post-Rescue - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.
Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.
During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD (rescue treatment) for the rest of the Part C.
MTX was administered orally as background therapy.
Adverse events were collected from predose of 8 mg LY3009104 QD until Week 76."
263201|NCT01185353|E12|Reported Event|4 to 8 mg LY3009104 QD Pre-Rescue - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.
Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.
During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD (rescue treatment) for the rest of the Part C.
MTX was administered orally as background therapy.
Adverse events were collected from Week 24 until predose of 8 mg LY3009104 QD."
263202|NCT01185353|E11|Reported Event|4 mg LY3009104 QD - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.
Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.
MTX was administered orally as background therapy."
263203|NCT01185353|E10|Reported Event|8 mg LY3009104 QD - Part B|"Participants who received 8 mg LY3009104 QD in Part A continued to receive 8 mg LY3009104 QD in Part B.
MTX was administered orally as background therapy."
263204|NCT01185353|E9|Reported Event|4 mg LY3009104 QD - Part B|"Participants who received 4 mg LY3009104 QD in Part A continued to receive 4 mg LY3009104 QD in Part B.
MTX was administered orally as background therapy."
263205|NCT01185353|E8|Reported Event|2 mg LY3009104 QD - Part B|"Participants who received 2 mg LY3009104 QD in Part A continued to receive 2 mg LY3009104 QD in Part B.
MTX was administered orally as background therapy."
263206|NCT01185353|E7|Reported Event|4 mg LY3009104 QD Crossover- Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.
MTX was administered orally as background therapy."
263207|NCT01185353|E6|Reported Event|2 mg LY3009104 BID Crossover- Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B.
MTX was administered orally as background therapy."
263208|NCT01185353|E5|Reported Event|Placebo QD - Part A|"Placebo administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263209|NCT01185353|E4|Reported Event|8 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263210|NCT01185353|E3|Reported Event|4 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Pat A.
MTX was administered orally as background therapy."
263211|NCT01185353|E2|Reported Event|2 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263212|NCT01185353|E1|Reported Event|1 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.
MTX was administered orally as background therapy."
263213|NCT01185301|B5|Baseline|Total|Total of all reporting groups
263214|NCT01185301|B4|Baseline|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263215|NCT01185301|B3|Baseline|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263216|NCT01185301|B2|Baseline|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263217|NCT01185301|B1|Baseline|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263218|NCT01185301|P4|Participant Flow|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263219|NCT01185301|P3|Participant Flow|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263220|NCT01185301|P2|Participant Flow|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263221|NCT01185301|P1|Participant Flow|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263222|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263223|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263224|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263225|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263226|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263227|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263228|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263229|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263230|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263231|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263232|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263317|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263234|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263235|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263236|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263237|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263238|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263239|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263240|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263241|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263242|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263243|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263244|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263245|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263246|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263247|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263248|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263249|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263250|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263251|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263252|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263253|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263254|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263255|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263256|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263257|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263258|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263259|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263260|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263261|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263262|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263263|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263264|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263265|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263266|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263267|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263268|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263269|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263270|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263271|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263272|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263274|NCT01185301|E4|Reported Event|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
263275|NCT01185301|E3|Reported Event|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263276|NCT01185301|E2|Reported Event|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
263277|NCT01185301|E1|Reported Event|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
263278|NCT01185288|B3|Baseline|Total|Total of all reporting groups
263279|NCT01185288|B2|Baseline|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
263280|NCT01185288|B1|Baseline|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
263281|NCT01185288|P2|Participant Flow|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
263282|NCT01185288|P1|Participant Flow|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
263283|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
263284|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
263285|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
263286|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
263287|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
263288|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
263289|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
263290|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
263291|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
263292|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
263293|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
263294|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
263295|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
263296|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
263297|NCT01185288|E2|Reported Event|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
263298|NCT01185288|E1|Reported Event|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
263299|NCT01185249|B1|Baseline|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
263300|NCT01185249|P1|Participant Flow|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
263301|NCT01185249|O2|Outcome|Morning Weight|Weight of study patients in kilograms first thing in the morning.
263302|NCT01185249|O1|Outcome|Evening Weights|Patients with both morning and evening weights
263303|NCT01185249|E1|Reported Event|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
263304|NCT01185080|B4|Baseline|Total|Total of all reporting groups
263305|NCT01185080|B3|Baseline|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263306|NCT01185080|B2|Baseline|Placebo|Placebo three times weekly
263307|NCT01185080|B1|Baseline|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263308|NCT01185080|P3|Participant Flow|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263309|NCT01185080|P2|Participant Flow|Placebo|Placebo three times weekly
263310|NCT01185080|P1|Participant Flow|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263311|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263312|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
263313|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263314|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263315|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
263316|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263325|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263326|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263327|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
263328|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263329|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263330|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
263331|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263332|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263333|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
263334|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263335|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263336|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
263337|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263338|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263339|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
263340|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263341|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263342|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
263343|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263344|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263345|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
263346|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263347|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263348|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
263349|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263350|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263351|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
263352|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263353|NCT01185080|E3|Reported Event|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
263354|NCT01185080|E2|Reported Event|Placebo|Placebo three times weekly
263355|NCT01185080|E1|Reported Event|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
263356|NCT01185028|B1|Baseline|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
263357|NCT01185028|P1|Participant Flow|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
263358|NCT01185028|O1|Outcome|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
263359|NCT01185028|O1|Outcome|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
263360|NCT01185028|E1|Reported Event|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
263361|NCT01184989|B1|Baseline|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
263362|NCT01184989|P1|Participant Flow|Patients Treated With Dabigatran Etexilate|"Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
142 patients were enrolled for the study, but only 112 were treated. Therefore, the number of started patients corresponds to the ones that were actually treated."
263363|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
263364|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
263365|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
263366|NCT01184989|E1|Reported Event|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
263367|NCT01184898|B1|Baseline|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
263368|NCT01184898|P1|Participant Flow|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
263369|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
263370|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
312787|NCT00236184|O2|Outcome|Rabeprazole 10 mg|
263371|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
263372|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
263373|NCT01184898|E1|Reported Event|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
263374|NCT01184885|B1|Baseline|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus
Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
263375|NCT01184885|P1|Participant Flow|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus
Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
263376|NCT01184885|O1|Outcome|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus
Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
263377|NCT01184885|O1|Outcome|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus
Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m^2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m^2 on day 6; Decadron 40mg/day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
Cycle B: Methotrexate 1000mg/m^2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m^2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
Rituximab (if given) will be 375 mg/m^2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
263378|NCT01184885|E1|Reported Event|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus
Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
263379|NCT01184872|B3|Baseline|Total|Total of all reporting groups
263380|NCT01184872|B2|Baseline|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
263381|NCT01184872|B1|Baseline|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
263382|NCT01184872|P2|Participant Flow|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
263383|NCT01184872|P1|Participant Flow|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
263413|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263492|NCT01184859|E5|Reported Event|Desmopressin 100µg - Period 1|Study period 1: single dose of desmopressin 100µg.
263384|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
263385|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
263386|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
263387|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
263388|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
263389|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
263390|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
263391|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
263392|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
263393|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
263394|NCT01184872|E2|Reported Event|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
263395|NCT01184872|E1|Reported Event|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
263396|NCT01184859|B6|Baseline|Total|Total of all reporting groups
263397|NCT01184859|B5|Baseline|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263398|NCT01184859|B4|Baseline|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263399|NCT01184859|B3|Baseline|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263400|NCT01184859|B2|Baseline|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263401|NCT01184859|B1|Baseline|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263402|NCT01184859|P5|Participant Flow|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263403|NCT01184859|P4|Participant Flow|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263404|NCT01184859|P3|Participant Flow|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263405|NCT01184859|P2|Participant Flow|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263406|NCT01184859|P1|Participant Flow|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263407|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263408|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263409|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263410|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263411|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263412|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263491|NCT01184859|E6|Reported Event|Placebo - Period 2|Study period 2: daily doses of placebo taken before bedtime for 28 days.
263414|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263415|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263416|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263417|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263418|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263419|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263420|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263421|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263422|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263423|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263424|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263425|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263426|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263427|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263428|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263429|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263430|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263431|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263432|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263433|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263434|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263435|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263436|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263437|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263438|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263439|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263440|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263441|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263442|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263443|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263444|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263445|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263446|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263447|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263448|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263449|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263450|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263451|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
312788|NCT00236184|O1|Outcome|Placebo|
263452|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263453|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263454|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263455|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263456|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263457|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263458|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263459|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263460|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263461|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263462|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263463|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263464|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263465|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263466|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263467|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263468|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263469|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263470|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263471|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263472|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263473|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263474|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263475|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263476|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263477|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263478|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263479|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263480|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263481|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263482|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263483|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263484|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263485|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263486|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
263487|NCT01184859|E10|Reported Event|Desmopressin 100µg - Period 2|Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
263488|NCT01184859|E9|Reported Event|Desmopressin 50µg - Period 2|Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
263489|NCT01184859|E8|Reported Event|Desmopressin 25µg - Period 2|Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
263490|NCT01184859|E7|Reported Event|Desmopressin 10µg - Period 2|Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
263493|NCT01184859|E4|Reported Event|Desmopressin 50µg - Period 1|Study period 1: single dose of desmopressin 50µg.
263494|NCT01184859|E3|Reported Event|Desmopressin 25µg - Period 1|Study period 1: single dose of desmopressin 25µg.
263495|NCT01184859|E2|Reported Event|Desmopressin 10µg - Period 1|Study period 1: single dose of desmopressin 10µg.
263496|NCT01184859|E1|Reported Event|Placebo-Period 1|Study period 1: single dose of placebo.
263497|NCT01184846|B1|Baseline|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263498|NCT01184846|P1|Participant Flow|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263499|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263500|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263501|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263502|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263503|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263504|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263505|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263506|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263507|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263508|NCT01184846|O2|Outcome|IgPro10 - After Infusion|IgG levels were determined after infusion with IgPro10.
263509|NCT01184846|O1|Outcome|IgPro10 - Before Infusion|IgG levels were determined before infusion with IgPro10.
263510|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263511|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263512|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263513|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263514|NCT01184846|E1|Reported Event|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
263515|NCT01184755|B4|Baseline|Total|Total of all reporting groups
263516|NCT01184755|B3|Baseline|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
263517|NCT01184755|B2|Baseline|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter
Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).
Sham RESPeRate"
263518|NCT01184755|B1|Baseline|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks
Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)
RESPeRate"
263519|NCT01184755|P3|Participant Flow|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
263520|NCT01184755|P2|Participant Flow|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter
Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).
Sham RESPeRate"
263521|NCT01184755|P1|Participant Flow|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks
Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)
RESPeRate"
263522|NCT01184755|O3|Outcome|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
263559|NCT01184079|B1|Baseline|12 Month Administration|"Administration of 3rd dose at 12 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
263523|NCT01184755|O2|Outcome|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter
Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).
Sham RESPeRate"
263524|NCT01184755|O1|Outcome|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks
Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)
RESPeRate"
263525|NCT01184755|E3|Reported Event|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
263526|NCT01184755|E2|Reported Event|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter
Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).
Sham RESPeRate"
263527|NCT01184755|E1|Reported Event|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks
Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)
RESPeRate"
263528|NCT01184417|B3|Baseline|Total|Total of all reporting groups
263529|NCT01184417|B2|Baseline|Placebo Group|100 ml saline
263530|NCT01184417|B1|Baseline|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
263531|NCT01184417|P2|Participant Flow|Placebo Group|100 ml saline
263532|NCT01184417|P1|Participant Flow|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
263533|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
263534|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
263535|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
263536|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
263537|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
263538|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
263539|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
263540|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
263541|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
263542|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
263543|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
263544|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
263545|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
263546|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
263547|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
263548|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
263549|NCT01184417|E2|Reported Event|Placebo Group|100 ml saline
263550|NCT01184417|E1|Reported Event|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
263551|NCT01184118|B1|Baseline|FP 220 mcg 2 Puffs BID|"The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
FP 220 mcg 2 puffs BID: The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care."
263552|NCT01184118|P1|Participant Flow|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by 2 weeks of FP 220 mcg 2 puffs BID then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks.
263553|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
263554|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
263555|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
263556|NCT01184118|E1|Reported Event|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
263557|NCT01184079|B3|Baseline|Total|Total of all reporting groups
263558|NCT01184079|B2|Baseline|6 Month Administration|"3rd dose administration at 6 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
263600|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
263560|NCT01184079|P2|Participant Flow|6 Month Administration|"3rd dose administration at 6 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
263561|NCT01184079|P1|Participant Flow|12 Month Administration|"Administration of 3rd dose at 12 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
263562|NCT01184079|O2|Outcome|Group With Administration of 3rd Dose at 6 Months|"Group with administration of 3rd dose at 6 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
263563|NCT01184079|O1|Outcome|Group With Administration of 3rd Dose at 12 Months|"Group with administration of 3rd dose at 12 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
263564|NCT01184079|O2|Outcome|6 Month Administration|"3rd dose administration at 6 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
263565|NCT01184079|O1|Outcome|12 Month Administration|"Administration of 3rd dose at 12 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
263566|NCT01184079|O2|Outcome|6 Month Administration|"3rd dose administration at 6 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
263567|NCT01184079|O1|Outcome|12 Month Administration|"Administration of 3rd dose at 12 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
263568|NCT01184079|E2|Reported Event|6 Month Administration|"3rd dose administration at 6 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
263569|NCT01184079|E1|Reported Event|12 Month Administration|"Administration of 3rd dose at 12 months
quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
263570|NCT01184053|B1|Baseline|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
263571|NCT01184053|P1|Participant Flow|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
263572|NCT01184053|O1|Outcome|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
263573|NCT01184053|O1|Outcome|Trisenox Treatment|"Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks."
263574|NCT01184053|O1|Outcome|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
263575|NCT01184053|O1|Outcome|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
263576|NCT01184053|E1|Reported Event|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
263577|NCT01184014|B3|Baseline|Total|Total of all reporting groups
263578|NCT01184014|B2|Baseline|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
263579|NCT01184014|B1|Baseline|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
263580|NCT01184014|P2|Participant Flow|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
263581|NCT01184014|P1|Participant Flow|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
263582|NCT01184014|O2|Outcome|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
263583|NCT01184014|O1|Outcome|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
263584|NCT01184014|E2|Reported Event|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
263585|NCT01184014|E1|Reported Event|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
263586|NCT01183975|B1|Baseline|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
263587|NCT01183975|P1|Participant Flow|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
263588|NCT01183975|O1|Outcome|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
263589|NCT01183975|O1|Outcome|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
263590|NCT01183975|E1|Reported Event|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
263591|NCT01183858|B3|Baseline|Total|Total of all reporting groups
263592|NCT01183858|B2|Baseline|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
263593|NCT01183858|B1|Baseline|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
263594|NCT01183858|P2|Participant Flow|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
263595|NCT01183858|P1|Participant Flow|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
263596|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
263597|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
263598|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
263599|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
263601|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
263602|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
263603|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
263604|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
263605|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
263606|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
263607|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
263608|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
263609|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
263610|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
263611|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
263612|NCT01183858|E2|Reported Event|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
263613|NCT01183858|E1|Reported Event|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
263614|NCT01183780|B3|Baseline|Total|Total of all reporting groups
263615|NCT01183780|B2|Baseline|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo: Administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263616|NCT01183780|B1|Baseline|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab: 8 mg/kg administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263617|NCT01183780|P2|Participant Flow|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo: Administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263618|NCT01183780|P1|Participant Flow|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil (FOLFIRI). Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab: 8 milligrams/kilogram (mg/kg) administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263619|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab: 8 mg/kg administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263620|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo: Administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263621|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab: 8 mg/kg administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263622|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo: Administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263623|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab: 8 mg/kg administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263624|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo: Administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263771|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263625|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab: 8 mg/kg administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263626|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo: Administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263627|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab: 8 mg/kg administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263628|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo: Administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263629|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab: 8 mg/kg administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263630|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo: Administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263631|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab: 8 mg/kg administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263632|NCT01183780|E2|Reported Event|FOLFIRI + Placebo|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo: Administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263633|NCT01183780|E1|Reported Event|FOLFIRI + Ramucirumab|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab: 8 mg/kg administered intravenously.
Irinotecan: 180 mg/m^2 administered intravenously.
Folinic Acid: 400 mg/m^2 administered intravenously.
5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
263634|NCT01183728|B1|Baseline|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection
Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
263635|NCT01183728|P1|Participant Flow|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection
Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
263636|NCT01183728|O1|Outcome|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection
Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
263637|NCT01183728|O1|Outcome|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection
Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
263683|NCT01183468|O3|Outcome|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week"
263638|NCT01183728|E1|Reported Event|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection
Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
263639|NCT01183650|B3|Baseline|Total|Total of all reporting groups
263640|NCT01183650|B2|Baseline|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
263641|NCT01183650|B1|Baseline|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
263642|NCT01183650|P2|Participant Flow|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
263643|NCT01183650|P1|Participant Flow|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
263644|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
263645|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
263646|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
263647|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
263648|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
263649|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
263650|NCT01183650|E2|Reported Event|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
263651|NCT01183650|E1|Reported Event|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
263652|NCT01183546|B1|Baseline|Wheelchair Users With ASIA A or B Spinal Cord Injury|wheelchair users with ASIA A or B spinal cord injury
263653|NCT01183546|P1|Participant Flow|Wheelchair Users With Spinal Cord Injury|wheelchair users with spinal cord injury
263654|NCT01183546|O2|Outcome|Followup Transfer Testing|Wheelchair users with spinal cord injury who met the criteria for transfer training at Baseline and returned four weeks later for transfer training and retesting.
263655|NCT01183546|O1|Outcome|Baseline Transfer Testing|Wheelchair Users with Spinal Cord Injury who met criteria for transfer training
263656|NCT01183546|O2|Outcome|Followup Transfer Testing|Wheelchair users with spinal cord injury who met the criteria for transfer training at Baseline and returned four weeks later for transfer training and retesting.
263657|NCT01183546|O1|Outcome|Baseline Transfer Testing|Wheelchair Users with Spinal Cord Injury who met criteria for transfer training
263658|NCT01183546|E1|Reported Event|Wheelchair Users With ASIA A or B Spinal Cord Injury|wheelchair users with ASIA A or B spinal cord injury
263659|NCT01183533|B1|Baseline|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.
Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
263660|NCT01183533|P1|Participant Flow|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.
Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
263661|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.
Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
263662|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.
Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
263663|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.
Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
263664|NCT01183533|E1|Reported Event|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.
Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
263665|NCT01183481|B1|Baseline|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
263666|NCT01183481|P1|Participant Flow|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
263667|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.
Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.
Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
263720|NCT01183234|B3|Baseline|Total|Total of all reporting groups
263721|NCT01183234|B2|Baseline|Metadate CD First, Then Equasym XL|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules)
263668|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.
Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.
Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
263669|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.
Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.
Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
263670|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.
Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.
Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
263671|NCT01183481|O1|Outcome|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
263672|NCT01183481|E1|Reported Event|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
263673|NCT01183468|B5|Baseline|Total|Total of all reporting groups
263674|NCT01183468|B4|Baseline|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week"
263675|NCT01183468|B3|Baseline|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week"
263676|NCT01183468|B2|Baseline|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
263677|NCT01183468|B1|Baseline|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
263678|NCT01183468|P4|Participant Flow|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week"
263679|NCT01183468|P3|Participant Flow|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week"
263680|NCT01183468|P2|Participant Flow|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
263681|NCT01183468|P1|Participant Flow|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
263682|NCT01183468|O4|Outcome|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.
Aralast NP 90 mg dose: - 90 mg/kg/week
Aralast NP 180 mg dose: - 180 mg/kg/week"
263722|NCT01183234|B1|Baseline|Equasym XL First, Then Metadate CD|Subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
263684|NCT01183468|O2|Outcome|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
263685|NCT01183468|O1|Outcome|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
263686|NCT01183468|E2|Reported Event|Subjects Aged 8 – 15 Years|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
263687|NCT01183468|E1|Reported Event|Subjects Aged 16 – 35 Years|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
263688|NCT01183390|B3|Baseline|Total|Total of all reporting groups
263689|NCT01183390|B2|Baseline|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
263690|NCT01183390|B1|Baseline|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
263691|NCT01183390|P2|Participant Flow|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
263692|NCT01183390|P1|Participant Flow|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
263693|NCT01183390|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
263694|NCT01183390|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
263695|NCT01183390|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
263696|NCT01183390|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
263697|NCT01183390|E2|Reported Event|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
263698|NCT01183390|E1|Reported Event|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period
263699|NCT01183312|B3|Baseline|Total|Total of all reporting groups
263700|NCT01183312|B2|Baseline|Flumazenil First, Then Placebo|Sublingual flumazenil during the first intervention day and placebo during the second intervention day (after washout period).
263701|NCT01183312|B1|Baseline|Placebo First, Then Flumazenil|Placebo during the first intervention day and sublingual flumazenil during the second intervention day (after washout period).
263702|NCT01183312|P2|Participant Flow|Flumazenil First, Then Placebo|Flumazenil administered sublingually three times during the first study day (as 12 mg, then 6 mg, then 6 mg, at approximately 3 hour intervals), followed by a washout of at least 7 days, then placebo administered sublingually three times on the second study day.
263703|NCT01183312|P1|Participant Flow|Placebo First, Then Flumazenil|Placebo administered sublingually three times during the first study day, followed by a washout of at least 7 days, then flumazenil administered sublingually three times during the second study day.
263704|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
263705|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
263706|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
263707|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
263708|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
263709|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
263710|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
263711|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
263712|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
263713|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
263714|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
263715|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
263716|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
263717|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
263718|NCT01183312|E2|Reported Event|Sublingual Flumazenil|
263719|NCT01183312|E1|Reported Event|Placebo|
263723|NCT01183234|P2|Participant Flow|Metadate CD First, Then Equasym XL|Subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules)
263724|NCT01183234|P1|Participant Flow|Equasym XL (SPD544) First, Then Metadate CD|Subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule)
263725|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
263726|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
263727|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
263728|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
263729|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
263730|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
263731|NCT01183234|E2|Reported Event|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
263732|NCT01183234|E1|Reported Event|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
263733|NCT01183169|B5|Baseline|Total|Total of all reporting groups
263734|NCT01183169|B4|Baseline|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263735|NCT01183169|B3|Baseline|Treatment C|Treatment C1 + Treatment C2. ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
263736|NCT01183169|B2|Baseline|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263737|NCT01183169|B1|Baseline|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263738|NCT01183169|P7|Participant Flow|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
263739|NCT01183169|P6|Participant Flow|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
263740|NCT01183169|P5|Participant Flow|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263741|NCT01183169|P4|Participant Flow|Treatment C2|Treatment C subset C2: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
263742|NCT01183169|P3|Participant Flow|Treatment C1|Treatment C subset C1: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR: hepatitis C virus (HCV) ribonucleic acid (RNA) <LOQ after 12 weeks of treatment) could switch to active ALV 600 mg QD with PEG and RBV.
263743|NCT01183169|P2|Participant Flow|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263744|NCT01183169|P1|Participant Flow|Treatment A|Alisporivir (ALV; DEB025) 600 mg once daily (QD) with peginterferon alfa-2a (PEG) and ribavirin (RBV) for up to 48 weeks.
263745|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
263746|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
263747|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263748|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
263749|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263750|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263751|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
263752|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
263753|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263754|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
263755|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263756|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263757|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
263758|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
263759|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263760|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
263761|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263762|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263763|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
263764|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
263765|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263766|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
263767|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263768|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263769|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
263770|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
263772|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
263773|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263774|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263775|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
263776|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
263777|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263778|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
263779|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263780|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263781|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
263782|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
263783|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263784|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
263785|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263786|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263787|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
263788|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
263789|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263790|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
263791|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263792|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263793|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
263794|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
263795|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263796|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
263797|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263798|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263799|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
263800|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
263801|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263802|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
263803|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263804|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263805|NCT01183169|E10|Reported Event|Treatment D: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263806|NCT01183169|E9|Reported Event|Treatment C2: Post-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
263807|NCT01183169|E8|Reported Event|Treatment C1: Post-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
263808|NCT01183169|E7|Reported Event|Treatment B: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263809|NCT01183169|E6|Reported Event|Treatment A: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263810|NCT01183169|E5|Reported Event|Treatment D: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
263811|NCT01183169|E4|Reported Event|Treatment C2: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
263812|NCT01183169|E3|Reported Event|Treatment C1: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
263813|NCT01183169|E2|Reported Event|Treatment B: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
263814|NCT01183169|E1|Reported Event|Treatment A: On-treatment AEs|Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
263815|NCT01183104|B3|Baseline|Total|Total of all reporting groups
263816|NCT01183104|B2|Baseline|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
263817|NCT01183104|B1|Baseline|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
263818|NCT01183104|P2|Participant Flow|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
263819|NCT01183104|P1|Participant Flow|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50).
263820|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
312789|NCT00236184|E2|Reported Event|Rabeprazole 10 mg|
263821|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
263822|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
263823|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
263824|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
263825|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
263826|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
263827|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
263828|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
263829|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
263830|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
263831|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
263832|NCT01183104|E2|Reported Event|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
263833|NCT01183104|E1|Reported Event|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
263834|NCT01183065|B1|Baseline|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.
Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
263835|NCT01183065|P1|Participant Flow|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.
Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
263836|NCT01183065|O1|Outcome|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.
Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
263837|NCT01183065|E1|Reported Event|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.
Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
263838|NCT01183013|B8|Baseline|Total|Total of all reporting groups
263839|NCT01183013|B7|Baseline|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
263840|NCT01183013|B6|Baseline|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
263841|NCT01183013|B5|Baseline|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by a blinded trial period on linagliptin 5mg + pioglitazone 30mg FDC
263842|NCT01183013|B4|Baseline|Lina5/Lina5|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
263843|NCT01183013|B3|Baseline|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
263844|NCT01183013|B2|Baseline|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
263845|NCT01183013|B1|Baseline|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
263846|NCT01183013|P7|Participant Flow|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
263890|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
263847|NCT01183013|P6|Participant Flow|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
263848|NCT01183013|P5|Participant Flow|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
263849|NCT01183013|P4|Participant Flow|Lina5/Lina5|Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
263850|NCT01183013|P3|Participant Flow|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
263851|NCT01183013|P2|Participant Flow|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
263852|NCT01183013|P1|Participant Flow|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
263853|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
263854|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
263855|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
263856|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
263857|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
263858|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
263859|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
263860|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
263861|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
263862|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
263863|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
263864|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
263865|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
263866|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
263867|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
263868|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
263869|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
263870|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
263871|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
263872|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
263873|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
263874|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
263875|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
263876|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
263877|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
263878|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
263879|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
263880|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
263881|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
263882|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
263883|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
263884|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
263885|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
263886|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
263887|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
263888|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
263889|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
263891|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
263892|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
263893|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
263894|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
263895|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
263896|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
263897|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
263898|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
263899|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
263900|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
263901|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
263902|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
263903|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
263904|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
263905|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
263906|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks
263907|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
263908|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
263909|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
263910|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
263911|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
263912|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
263913|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks
263914|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
263915|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
263916|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
263917|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
263918|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
263919|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
263920|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
263921|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
263922|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
263923|NCT01183013|E7|Reported Event|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
263924|NCT01183013|E6|Reported Event|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
263925|NCT01183013|E5|Reported Event|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
263926|NCT01183013|E4|Reported Event|Lina5/Lina5|Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
263927|NCT01183013|E3|Reported Event|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
263928|NCT01183013|E2|Reported Event|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
263929|NCT01183013|E1|Reported Event|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
263930|NCT01182805|B1|Baseline|Single Arm Study.|
263931|NCT01182805|P1|Participant Flow|All Study Participants|All study participants underwent measurement of Diastolic Circumferential Strain Rate during Isovolumic Relaxation as well as measurement of E-prime by tissue Doppler. They also all had evaluation of their diastolic function by the combination of their mitral inflow pattern and invasive measure of left ventricular end-diastolic pressure.
263932|NCT01182805|O3|Outcome|Grade 2 Diastolic Dysfunction|These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg).
263933|NCT01182805|O2|Outcome|Grade 1 Diastolic Dysfunction|These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0).
263934|NCT01182805|O1|Outcome|Normal Diastolic Function|These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP <= 15 mm Hg).
263935|NCT01182805|O3|Outcome|Grade 2 Diastolic Dysfunction|These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg).
263936|NCT01182805|O2|Outcome|Grade 1 Diastolic Dysfunction|These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0).
263937|NCT01182805|O1|Outcome|Normal Diastolic Function|These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP <= 15 mm Hg).
263938|NCT01182805|E1|Reported Event|Single Arm Study.|
263939|NCT01182727|B1|Baseline|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
263940|NCT01182727|P1|Participant Flow|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
263941|NCT01182727|O1|Outcome|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
263942|NCT01182727|E1|Reported Event|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
263943|NCT01182675|B3|Baseline|Total|Total of all reporting groups
263944|NCT01182675|B2|Baseline|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor
Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
263945|NCT01182675|B1|Baseline|T-cell Graft Permissive SCID|"Patients with SCID with:
i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor
Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
263946|NCT01182675|P2|Participant Flow|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor
Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
263947|NCT01182675|P1|Participant Flow|T-cell Graft Permissive SCID|"Patients with SCID with:
i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor
Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
263948|NCT01182675|O2|Outcome|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor
Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
263949|NCT01182675|O1|Outcome|T-cell Graft Permissive SCID|"Patients with SCID with:
i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor
Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
263950|NCT01182675|E2|Reported Event|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor
Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
263983|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
265779|NCT00003377|O3|Outcome|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
263951|NCT01182675|E1|Reported Event|T-cell Graft Permissive SCID|"Patients with SCID with:
i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor
Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
263952|NCT01182610|B1|Baseline|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43
Paclitaxel 200mg/m2 on Days 1 and 22
Carboplatin AUC=6 on Days 1 and 22
5FU 225mg/m2/day on Days 1-15 and 22-36
Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43
Paclitaxel 200mg/m2 on Days 1 and 22
Carboplatin AUC=6 on Days 1 and 22
5FU 225mg/m2/day on Days 1-15 and 22-36"
263953|NCT01182610|P1|Participant Flow|Treatment Group|"Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43
Paclitaxel 200mg/m2 on Days 1 and 22
Carboplatin AUC=6 on Days 1 and 22
5FU 225mg/m2/day on Days 1-15 and 22-36"
263954|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43
Paclitaxel 200mg/m2 on Days 1 and 22
Carboplatin AUC=6 on Days 1 and 22
5FU 225mg/m2/day on Days 1-15 and 22-36"
263955|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43
Paclitaxel 200mg/m2 on Days 1 and 22
Carboplatin AUC=6 on Days 1 and 22
5FU 225mg/m2/day on Days 1-15 and 22-36"
263956|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43
Paclitaxel 200mg/m2 on Days 1 and 22
Carboplatin AUC=6 on Days 1 and 22
5FU 225mg/m2/day on Days 1-15 and 22-36"
263957|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43
Paclitaxel 200mg/m2 on Days 1 and 22
Carboplatin AUC=6 on Days 1 and 22
5FU 225mg/m2/day on Days 1-15 and 22-36"
263958|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43
Paclitaxel 200mg/m2 on Days 1 and 22
Carboplatin AUC=6 on Days 1 and 22
5FU 225mg/m2/day on Days 1-15 and 22-36"
263959|NCT01182610|E1|Reported Event|Treatment Group: Panitumumab, Paclitaxel, Carboplatin and 5FU|Panitumumab 9mg/kg on Days 1, 22, and 43; Paclitaxel 200mg/m2 on Days 1 and 22; Carboplatin AUC=6 on Days 1 and 22; 5FU 225mg/m2/day on Days 1-15 and 22-36
263960|NCT01182493|B3|Baseline|Total|Total of all reporting groups
263961|NCT01182493|B2|Baseline|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
263962|NCT01182493|B1|Baseline|Insulin Pump Treatment|"Patients will get an insulin pump
Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient"
263963|NCT01182493|P2|Participant Flow|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
263964|NCT01182493|P1|Participant Flow|Insulin Pump Treatment|"Patients will get an insulin pump
Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
263965|NCT01182493|O2|Outcome|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
263966|NCT01182493|O1|Outcome|Insulin Pump Treatment|"Patients will get an insulin pump
Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
263967|NCT01182493|E2|Reported Event|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
263968|NCT01182493|E1|Reported Event|Insulin Pump Treatment|"Patients will get an insulin pump
Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
263969|NCT01182480|B1|Baseline|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
263970|NCT01182480|P1|Participant Flow|Text Intervention|Group of study participants who received the text message intervention over a 3-month period. Participants received text messages 7, 2, and 1 day(s) prior to each of their scheduled appointments as recorded in the Denver Health scheduling system, and also received text messages prompts 3 times per week asking them to provide fasting blood sugar readings.
263971|NCT01182480|O1|Outcome|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
263972|NCT01182480|E1|Reported Event|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
263973|NCT01182428|B3|Baseline|Total|Total of all reporting groups
263974|NCT01182428|B2|Baseline|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263975|NCT01182428|B1|Baseline|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263976|NCT01182428|P2|Participant Flow|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263977|NCT01182428|P1|Participant Flow|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263978|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263979|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263980|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263981|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263982|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264093|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
263984|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263985|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263986|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263987|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263988|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263989|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263990|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263991|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263992|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263993|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263994|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263995|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263996|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263997|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263998|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
263999|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264000|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264001|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264002|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264003|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264004|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264005|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264006|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264007|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264008|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264009|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264010|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264011|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264012|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264013|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264014|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264015|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264016|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264017|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264018|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264019|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264020|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264021|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264022|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264023|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264024|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264025|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264026|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264027|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264028|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264029|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264030|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264031|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264032|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264033|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264034|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264035|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264036|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264037|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264038|NCT01182428|E2|Reported Event|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264039|NCT01182428|E1|Reported Event|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
264040|NCT01182376|B3|Baseline|Total|Total of all reporting groups
264041|NCT01182376|B2|Baseline|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.
dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
264042|NCT01182376|B1|Baseline|Placebo|"Half of the patients will be assigned placebo.
dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
264043|NCT01182376|P2|Participant Flow|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.
dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
264044|NCT01182376|P1|Participant Flow|Placebo|"Half of the patients will be assigned placebo.
dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
264045|NCT01182376|O2|Outcome|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.
dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
264046|NCT01182376|O1|Outcome|Placebo|"Half of the patients will be assigned placebo.
dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
264047|NCT01182376|E2|Reported Event|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.
dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
264048|NCT01182376|E1|Reported Event|Placebo|"Half of the patients will be assigned placebo.
dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
264049|NCT01182337|B3|Baseline|Total|Total of all reporting groups
264050|NCT01182337|B2|Baseline|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
264051|NCT01182337|B1|Baseline|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
264052|NCT01182337|P2|Participant Flow|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
264053|NCT01182337|P1|Participant Flow|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
264054|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
264055|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
264056|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
264057|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
264058|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
264059|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
264060|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
264061|NCT01182337|O1|Outcome|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
264062|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
264063|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
264064|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
264065|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
264066|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
264067|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
264068|NCT01182337|E2|Reported Event|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
264069|NCT01182337|E1|Reported Event|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
264070|NCT01182298|B1|Baseline|Standard|HCV INFECTED LATINO ARTICIPANTS
264071|NCT01182298|P1|Participant Flow|PegIFN and Ribavirin|"Latino Patients with hepatitis C receiving weekly pegIFN and ribavirin.
This is an observational study. The observed treatment is received and managed through their primary care."
264072|NCT01182298|O1|Outcome|Hepatitis C|latino participants with Hepatitis C
264073|NCT01182298|E1|Reported Event|Standard|Patients receiving weekly peg interferon and ribavirin for hCV treatment were studied This is an observational study. The observed treatment is received and managed through their primary care.
264094|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264095|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
264096|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264097|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
265319|NCT00001941|P2|Participant Flow|Phase I - 4 mg/kg Cohort|4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
264074|NCT01182285|B1|Baseline|All Participants (Phase 1 and Phase 2 Schedule 2)|"A- Phase 1 Radioiodine-Resistant Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
B2 - Phase 2 Schedule 2 Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks."
264075|NCT01182285|P3|Participant Flow|B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
264076|NCT01182285|P2|Participant Flow|B1 - Phase 2 Schedule 1 (Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 17 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Drug: Cytomel (25 micrograms) Patients who exhibit an increased radioiodine uptake on Thyrogen scan post valproic acid therapy at week 10. Begin Liothyronine Sodium (Cytomel) for 4 weeks (25 micrograms twice a day)
264077|NCT01182285|P1|Participant Flow|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
264078|NCT01182285|O1|Outcome|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
264079|NCT01182285|O1|Outcome|B2 - Phase 2 Schedule 2 (No Increased Radiiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
264080|NCT01182285|O1|Outcome|All Participants|A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
264081|NCT01182285|O2|Outcome|B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
264082|NCT01182285|O1|Outcome|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
264083|NCT01182285|E1|Reported Event|All Participants (Phase 1 and Phase 2 Schedule 2)|A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
264084|NCT01182207|B3|Baseline|Total|Total of all reporting groups
264085|NCT01182207|B2|Baseline|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
264086|NCT01182207|B1|Baseline|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
264087|NCT01182207|P2|Participant Flow|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
264088|NCT01182207|P1|Participant Flow|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
264089|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
264090|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264091|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
264092|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
265780|NCT00003377|O2|Outcome|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
264098|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264099|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
264100|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264101|NCT01182207|E2|Reported Event|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
264102|NCT01182207|E1|Reported Event|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264103|NCT01182194|B3|Baseline|Total|Total of all reporting groups
264104|NCT01182194|B2|Baseline|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
264105|NCT01182194|B1|Baseline|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
264106|NCT01182194|P2|Participant Flow|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
264107|NCT01182194|P1|Participant Flow|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
264108|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
264109|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264110|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
264111|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264112|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
264113|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264114|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
264115|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264116|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
264117|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264118|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
264119|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
264120|NCT01182194|E2|Reported Event|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
264121|NCT01182194|E1|Reported Event|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
264122|NCT01182181|B3|Baseline|Total|Total of all reporting groups
264123|NCT01182181|B2|Baseline|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
264124|NCT01182181|B1|Baseline|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
264125|NCT01182181|P2|Participant Flow|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
264126|NCT01182181|P1|Participant Flow|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
264127|NCT01182181|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
264128|NCT01182181|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
264129|NCT01182181|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
264130|NCT01182181|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
264131|NCT01182181|E2|Reported Event|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
264132|NCT01182181|E1|Reported Event|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
264133|NCT01182103|B3|Baseline|Total|Total of all reporting groups
264134|NCT01182103|B2|Baseline|Healthy Subjects|
264135|NCT01182103|B1|Baseline|Major Depressive Patients|
264136|NCT01182103|P2|Participant Flow|Healthy Subjects|
264137|NCT01182103|P1|Participant Flow|Major Depressive Patients|
264138|NCT01182103|O3|Outcome|Major Depressive Patients After Treatment|
264139|NCT01182103|O2|Outcome|Major Depressive Patients Before Treatment|
264140|NCT01182103|O1|Outcome|Healthy Subjects|
264141|NCT01182103|O3|Outcome|Major Depressive Patients After Treatment|
264142|NCT01182103|O2|Outcome|Major Depressive Patients Before Treatment|
264143|NCT01182103|O1|Outcome|Healthy Subjects|
264144|NCT01182103|O2|Outcome|Healthy Subjects|
264145|NCT01182103|O1|Outcome|Major Depressive Patients|
264146|NCT01182103|E2|Reported Event|Healthy Subjects|
264147|NCT01182103|E1|Reported Event|Major Depressive Patients|
264148|NCT01181986|B3|Baseline|Total|Total of all reporting groups
264149|NCT01181986|B2|Baseline|Sub-study 2: Exenatide IV|Intravenous infusion of (1) Saline+Exenatide, (2) Saline+Placebo or (3) Exendin-9+Exenatide on 3 seperate days, crossover study
264150|NCT01181986|B1|Baseline|Sub-study 1: Exenatide SC|Exenatide 5-10 ug or placebo sc BID/10 days, day 11 AM dose and meal test - crossover study
264151|NCT01181986|P3|Participant Flow|Exenatide IV (Sub-study 2)|Patients received in random order on single day an intravenous infusion of (1) Saline+Exenatide, (2) Exendin-9+Exenatide or (3) Saline+Placebo
264152|NCT01181986|P2|Participant Flow|Placebo Then Exenatide (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
264153|NCT01181986|P1|Participant Flow|Exenatide Then Placebo (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
264154|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
264155|NCT01181986|O1|Outcome|Exenatide (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
264156|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
264157|NCT01181986|O1|Outcome|Exenatide (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
264158|NCT01181986|O5|Outcome|Exendin-9+Exenatide (Sub-study 2)|Infusion of exendin-9 (min 0-75), added exenatide infusion (min 30-75)
264159|NCT01181986|O4|Outcome|Saline+Placebo (Sub-study 2)|Infusion of saline (min 0-75), added placebo infusion (min 30-75)
264160|NCT01181986|O3|Outcome|Saline+Exenatide (Sub-study 2)|Infusion of saline (min 0-75), added exenatide infusion (min 30-75)
264161|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Placebo sc BID for 10 days
264162|NCT01181986|O1|Outcome|Exenatide (Subs-study 1)|Exenatide: Exenatide 5-10 ug sc BID/10 days
264163|NCT01181986|E5|Reported Event|Exendin-9+Exenatide IV (Sub-study 2)|Intravenous infusion of exendin-9 (min 0-75), added intravenous infusion of placebo (min30-75)
264164|NCT01181986|E4|Reported Event|Saline+Placebo (Sub-study 2)|Intravenous infusion of saline (min 0-75), added intravenous infusion of placebo (min30-75)
264165|NCT01181986|E3|Reported Event|Saline+Exenatide IV (Sub-study 2)|Intravenous infusion of saline (min 0-75), added intravenous infusion of exenatide (min30-75)
264166|NCT01181986|E2|Reported Event|Placebo SC (Sub-study 1)|Placebo sc BID/10days, AM dose and meal test on day 11
264167|NCT01181986|E1|Reported Event|Exenatide SC (Sub-study 1)|Exenatide 5-10 ug sc BID/10 days, AM dose and meal test on day 11
264168|NCT01181947|B1|Baseline|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >
> TEVAR: Thoracic endovascular aneurysm repair"
264169|NCT01181947|P1|Participant Flow|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >
> TEVAR: Thoracic endovascular aneurysm repair"
264170|NCT01181947|O1|Outcome|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >
> TEVAR: Thoracic endovascular aneurysm repair"
264171|NCT01181947|O1|Outcome|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection
TEVAR: Thoracic endovascular aneurysm repair"
264172|NCT01181947|E1|Reported Event|1. VCOUS|Medtronic VCOUS
264173|NCT01181921|B1|Baseline|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
264174|NCT01181921|P1|Participant Flow|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
264175|NCT01181921|O1|Outcome|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
264176|NCT01181921|E1|Reported Event|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
264177|NCT01181895|B4|Baseline|Total|Total of all reporting groups
264178|NCT01181895|B3|Baseline|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264179|NCT01181895|B2|Baseline|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264180|NCT01181895|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
264181|NCT01181895|P3|Participant Flow|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264182|NCT01181895|P2|Participant Flow|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264226|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
264183|NCT01181895|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
264184|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264185|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264186|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
264187|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264188|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264189|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
264190|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264191|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264192|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
264193|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264194|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264195|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
264196|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264197|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264198|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
264199|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264200|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264201|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
265320|NCT00001941|P1|Participant Flow|Phase I - 2 mg/kg Cohort|2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2
264202|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264203|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264204|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
264205|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264206|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264207|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
264208|NCT01181895|E3|Reported Event|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264209|NCT01181895|E2|Reported Event|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
264210|NCT01181895|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
264211|NCT01181804|B5|Baseline|Total|Total of all reporting groups
264212|NCT01181804|B4|Baseline|Boceprevir Capsules Then Tablets (Fasted)|Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.
264213|NCT01181804|B3|Baseline|Boceprevir Tablets Then Capsules (Fasted)|Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
264214|NCT01181804|B2|Baseline|Boceprevir Capsules Then Tablets (Fed)|Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
264215|NCT01181804|B1|Baseline|Boceprevir Tablets Then Capsules (Fed)|Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
264216|NCT01181804|P4|Participant Flow|Boceprevir Capsules Then Tablets (Fasted)|Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.
264217|NCT01181804|P3|Participant Flow|Boceprevir Tablets Then Capsules (Fasted)|Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
264218|NCT01181804|P2|Participant Flow|Boceprevir Capsules Then Tablets ( Fed)|Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
264219|NCT01181804|P1|Participant Flow|Boceprevir Tablets Then Capsules ( Fed)|Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
264220|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
264221|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
264222|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
264223|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
264224|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
264225|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
264227|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
264228|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
264229|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
264230|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
264231|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
264232|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
264233|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
264234|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
264235|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
264236|NCT01181804|E4|Reported Event|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
264237|NCT01181804|E3|Reported Event|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
264238|NCT01181804|E2|Reported Event|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
264239|NCT01181804|E1|Reported Event|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
264240|NCT01181778|B1|Baseline|All Participants|All participants who were enrolled in the study
264241|NCT01181778|P1|Participant Flow|All Participants|All participants who were enrolled in the study
264242|NCT01181778|O1|Outcome|All Qualified Participants|All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
264243|NCT01181778|O2|Outcome|All Qualified Participants After Counseling|After counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
264244|NCT01181778|O1|Outcome|All Qualified Participants Before Counseling|Before counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
264245|NCT01181778|E1|Reported Event|All Qualified Participants|All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis and safety analysis, based on the physician's assessment
264246|NCT01181726|B3|Baseline|Total|Total of all reporting groups
264247|NCT01181726|B2|Baseline|Activella® (Reference) First|1 mg/0.5 mg Activella® Tablets reference product dosed in first period followed by 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in the second period.
264248|NCT01181726|B1|Baseline|Estradiol/Norethindrone Acetate (Test) First|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in first period followed by 1 mg/0.5 mg Activella® Tablets reference product dosed in the second period.
264249|NCT01181726|P2|Participant Flow|Activella® (Reference) First|1 mg/0.5 mg Activella® Tablets reference product dosed in first period followed by 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in the second period.
264250|NCT01181726|P1|Participant Flow|Estradiol/Norethindrone Acetate (Test) First|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in first period followed by 1 mg/0.5 mg Activella® Tablets reference product dosed in the second period.
264251|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264252|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264253|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264254|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264255|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264256|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264257|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264258|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264259|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264260|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264261|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
265781|NCT00003377|O1|Outcome|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
264262|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264263|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264264|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264265|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264266|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264267|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264268|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264269|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264270|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264271|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264272|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264273|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264274|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264275|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264276|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264277|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264278|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264279|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264280|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264281|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264282|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264283|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264284|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264285|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264286|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264287|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264288|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264289|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264290|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264291|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264292|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264293|NCT01181726|E2|Reported Event|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
264294|NCT01181726|E1|Reported Event|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
264295|NCT01181609|B1|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
264296|NCT01181609|P1|Participant Flow|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 milligrams per kilogram (mg/kg) intravenously (IV) per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
264297|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
264298|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
264341|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
264342|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
264299|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
264300|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
264301|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
264302|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
264303|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
264304|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
264305|NCT01181609|E1|Reported Event|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
264306|NCT01181531|B3|Baseline|Total|Total of all reporting groups
264307|NCT01181531|B2|Baseline|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
264308|NCT01181531|B1|Baseline|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
264309|NCT01181531|P2|Participant Flow|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
264310|NCT01181531|P1|Participant Flow|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
264311|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
264312|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
264313|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
264314|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
264315|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
264316|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
264317|NCT01181531|E2|Reported Event|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
264318|NCT01181531|E1|Reported Event|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
264319|NCT01181492|B4|Baseline|Total|Total of all reporting groups
264320|NCT01181492|B3|Baseline|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
264321|NCT01181492|B2|Baseline|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
264322|NCT01181492|B1|Baseline|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
264323|NCT01181492|P3|Participant Flow|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
264324|NCT01181492|P2|Participant Flow|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
264325|NCT01181492|P1|Participant Flow|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
264326|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
264327|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
264328|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
264329|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
264330|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
264331|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
264332|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
264333|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
264334|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
264335|NCT01181492|E3|Reported Event|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
264336|NCT01181492|E2|Reported Event|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
264337|NCT01181492|E1|Reported Event|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
264338|NCT01181349|B1|Baseline|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia
with neuromuscular blocking agents"
264339|NCT01181349|P1|Participant Flow|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia
with neuromuscular blocking agents"
264340|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
264529|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264343|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
264344|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
264345|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
264346|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
264347|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
264348|NCT01181349|O1|Outcome|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia
with neuromuscular blocking agents"
264349|NCT01181349|E1|Reported Event|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia
with neuromuscular blocking agents"
264350|NCT01181323|B5|Baseline|Total|Total of all reporting groups
264351|NCT01181323|B4|Baseline|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
264352|NCT01181323|B3|Baseline|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
264353|NCT01181323|B2|Baseline|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
264354|NCT01181323|B1|Baseline|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
264355|NCT01181323|P4|Participant Flow|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
264356|NCT01181323|P3|Participant Flow|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
264357|NCT01181323|P2|Participant Flow|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
264358|NCT01181323|P1|Participant Flow|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection
264359|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
264360|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
264361|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
264362|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
264363|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
264364|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
264365|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
264366|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
264367|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
264368|NCT01181323|O3|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
264369|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
264370|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
264371|NCT01181323|O1|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
264372|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
264373|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
264374|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
264375|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
264376|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
264377|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
264378|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
264379|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
264380|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
264381|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
264382|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
264383|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
264384|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
264385|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
264386|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
264387|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
264388|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
264389|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
264390|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
264391|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
264392|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
264393|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
264394|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
264395|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
264396|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
264397|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
264398|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
264399|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
264400|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
264401|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
264402|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
264530|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
312790|NCT00236184|E1|Reported Event|Placebo|
264403|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
264404|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
264405|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
264406|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
264407|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
264408|NCT01181323|O2|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
264409|NCT01181323|O1|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
264410|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
264411|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
264412|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
264413|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
264414|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
264415|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
264416|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
264417|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
264418|NCT01181323|O2|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
264419|NCT01181323|O1|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
264420|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
264421|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
264422|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
264423|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
264424|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
264425|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
264426|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
264427|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
264428|NCT01181323|E4|Reported Event|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
264429|NCT01181323|E3|Reported Event|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
264430|NCT01181323|E2|Reported Event|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
264431|NCT01181323|E1|Reported Event|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
264432|NCT01181271|B1|Baseline|Autologous Then Allogeneic Transplant|Autologous then allogeneic stem cell transplantation
264433|NCT01181271|P1|Participant Flow|Autologous Then Allogeneic Transplant|Autologous, then Allogeneic Stem Cell Transplantation
264637|NCT01180998|B3|Baseline|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
264434|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264435|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264436|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264437|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264438|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264439|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264440|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264441|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264442|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264443|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264638|NCT01180998|B2|Baseline|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
264639|NCT01180998|B1|Baseline|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
264444|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264445|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264446|NCT01181271|E1|Reported Event|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.
Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.
Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
264447|NCT01181258|B1|Baseline|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL
Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)
Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.
Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)
Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine
Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion
Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
264448|NCT01181258|P1|Participant Flow|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL
Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)
Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.
Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)
Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine
Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion
Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
264449|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL
Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)
Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.
Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)
Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine
Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion
Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
264450|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL
Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)
Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.
Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)
Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine
Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion
Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
264451|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL
Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)
Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.
Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)
Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine
Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion
Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
264640|NCT01180998|P3|Participant Flow|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
265539|NCT00002874|P1|Participant Flow|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
264452|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL
Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)
Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.
Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)
Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine
Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion
Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
264453|NCT01181258|E1|Reported Event|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL
Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)
Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.
Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)
Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine
Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion
Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
264454|NCT01181167|B3|Baseline|Total|Total of all reporting groups
264455|NCT01181167|B2|Baseline|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium"
264456|NCT01181167|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban"
264457|NCT01181167|P2|Participant Flow|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium"
264458|NCT01181167|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban"
264459|NCT01181167|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium"
264460|NCT01181167|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban"
264461|NCT01181167|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium"
264462|NCT01181167|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban"
264463|NCT01181167|E2|Reported Event|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium"
264464|NCT01181167|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban"
264465|NCT01181141|B3|Baseline|Total|Total of all reporting groups
264466|NCT01181141|B2|Baseline|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
Enoxaparin sodium 20mg"
264467|NCT01181141|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
DU-176b (edoxaban)"
264468|NCT01181141|P2|Participant Flow|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
Enoxaparin sodium 20mg"
264469|NCT01181141|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
DU-176b (edoxaban)"
264470|NCT01181141|O2|Outcome|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
Enoxaparin sodium 20mg"
264471|NCT01181141|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
DU-176b (edoxaban)"
264472|NCT01181141|E2|Reported Event|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
Enoxaparin sodium 20mg"
264473|NCT01181141|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
DU-176b (edoxaban)"
264474|NCT01181128|B4|Baseline|Total|Total of all reporting groups
264475|NCT01181128|B3|Baseline|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264476|NCT01181128|B2|Baseline|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264477|NCT01181128|B1|Baseline|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264478|NCT01181128|P3|Participant Flow|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264479|NCT01181128|P2|Participant Flow|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264557|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis, Advate|"Participants underwent pharmacokinetic (PK) analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) and then a single dose of 50 IU/kg rFVIIIFc (rFVIIIFc Day 0) within 8 weeks of the Advate dose. A >= 96 hour washout from Advate or any other FVIII product was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via IV injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264480|NCT01181128|P1|Participant Flow|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264481|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
264482|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
264483|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
264484|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
264485|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
264486|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264487|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264488|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264489|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264490|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264491|NCT01181128|O2|Outcome|Arm 1: Individualized Prophylaxis, Prestudy On-demand|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264492|NCT01181128|O1|Outcome|Arm 1: Individualized Prophylaxis, Prestudy Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264493|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264494|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264495|NCT01181128|O2|Outcome|Arm 1: Individualized Prophylaxis, Prestudy On-demand|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264558|NCT01181128|O4|Outcome|All Arms: Total|All participants from the Individualized (Tailored) Prophylaxis, Weekly Prophylaxis, and Episodic (On-Demand) Dosing arms.
264559|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264496|NCT01181128|O1|Outcome|Arm 1: Individualized Prophylaxis, Prestudy Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264497|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264498|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264499|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264500|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264501|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264502|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264560|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264776|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
264503|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264504|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264505|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264506|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264507|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264508|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264509|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264510|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264511|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264512|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264615|NCT01181011|O2|Outcome|Telmisartan 80mg|
264616|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264617|NCT01181011|O2|Outcome|Telmisartan 80mg|
264618|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264619|NCT01181011|O2|Outcome|Telmisartan 80mg|
264620|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264621|NCT01181011|O2|Outcome|Amlodipine 5mg|
264622|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264623|NCT01181011|O2|Outcome|Amlodipine 5mg|
264624|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264513|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264514|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264515|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264516|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264517|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264518|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264519|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264520|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264521|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264522|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264523|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264524|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264525|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264526|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264527|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264528|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264531|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264532|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264533|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264534|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264535|NCT01181128|O2|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264536|NCT01181128|O1|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264537|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264538|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264539|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264540|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264625|NCT01181011|O2|Outcome|Amlodipine 5mg|
264626|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264627|NCT01181011|O2|Outcome|Telmisartan 80mg|
264628|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264629|NCT01181011|O2|Outcome|Telmisartan 80mg|
264630|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264631|NCT01181011|O2|Outcome|Telmisartan 80mg|
264632|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264633|NCT01181011|E3|Reported Event|Amlodipine 5mg|
264634|NCT01181011|E2|Reported Event|Telmisartan 80mg|
264541|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264542|NCT01181128|O2|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264543|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264544|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264545|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264546|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264547|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264548|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264549|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264550|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264551|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264552|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264553|NCT01181128|O5|Outcome|Any Arm: Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
264554|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
264555|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264556|NCT01181128|O2|Outcome|Arm 1: Individualized (Tailored) Prophylaxis, rFVIIIFc Only|"On rFVIIIFc Day 0, participants underwent pharmacokinetic (PK) analysis with a single dose of 50 IU/kg rFVIIIFc in order to estimate their PK parameters and guide the appropriate dose or interval of dosing.
After the PK assessment, participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by PK analyses, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264635|NCT01181011|E1|Reported Event|Telmisartan 80mg, Amlodipine 5mg|
264636|NCT01180998|B4|Baseline|Total|Total of all reporting groups
264561|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
264562|NCT01181128|E3|Reported Event|Episodic (On-Demand) Dosing|Initial single dose of 50 IU/kg of rFVIIIFc via IV injection followed by 10 to 50 IU/kg rFVIIIFc, as required to treat a bleeding episode
264563|NCT01181128|E2|Reported Event|Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
264564|NCT01181128|E1|Reported Event|Individualized (Tailored) Prophylaxis, rFVIIIFc|"Initial twice weekly dosing with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days to maintain a trough level of 1% to 3% (or higher, as clinically indicated) rFVIIIFc activity.
Prior to rFVIIIFc treatment, on rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with rFVIIIFc in order to estimate participant's PK parameters and guide the appropriate dose or interval of dosing. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.
A subset of participants (Sequential PK Subgroup) also had PK profiling performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout from Advate or any other FVIII product was performed before the first PK dose of rFVIIIFc was administered."
264565|NCT01181102|B3|Baseline|Total|Total of all reporting groups
264566|NCT01181102|B2|Baseline|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium"
264567|NCT01181102|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban"
264568|NCT01181102|P2|Participant Flow|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium"
264569|NCT01181102|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban"
264570|NCT01181102|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium"
264571|NCT01181102|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban"
264572|NCT01181102|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium"
264573|NCT01181102|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban"
264574|NCT01181102|E2|Reported Event|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium"
264575|NCT01181102|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban"
264576|NCT01181050|B3|Baseline|Total|Total of all reporting groups
264577|NCT01181050|B2|Baseline|Placebo|Subjects received a single dose of placebo
264578|NCT01181050|B1|Baseline|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
264579|NCT01181050|P2|Participant Flow|Placebo|Subjects received a single dose of placebo
264580|NCT01181050|P1|Participant Flow|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
264581|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
264582|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
264583|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
264584|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
264585|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
264586|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
264587|NCT01181050|E2|Reported Event|Placebo|Subjects received a single dose of placebo
264588|NCT01181050|E1|Reported Event|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
264589|NCT01181011|B1|Baseline|All Participants|all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order
264590|NCT01181011|P1|Participant Flow|All Participants|
264591|NCT01181011|O3|Outcome|Amlodipine 5mg|
264592|NCT01181011|O2|Outcome|Telmisartan 80mg|
264593|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264594|NCT01181011|O3|Outcome|Amlodipine 5mg|
264595|NCT01181011|O2|Outcome|Telmisartan 80mg|
264596|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264597|NCT01181011|O2|Outcome|Amlodipine 5mg|
264598|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264599|NCT01181011|O2|Outcome|Amlodipine 5mg|
264600|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264601|NCT01181011|O2|Outcome|Amlodipine 5mg|
264602|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264603|NCT01181011|O2|Outcome|Amlodipine 5mg|
264604|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264605|NCT01181011|O2|Outcome|Amlodipine 5mg|
264606|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264607|NCT01181011|O2|Outcome|Amlodipine 5mg|
264608|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264609|NCT01181011|O2|Outcome|Telmisartan 80mg|
264610|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264611|NCT01181011|O2|Outcome|Telmisartan 80mg|
264612|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264613|NCT01181011|O2|Outcome|Telmisartan 80mg|
264614|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
264641|NCT01180998|P2|Participant Flow|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
264642|NCT01180998|P1|Participant Flow|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
264643|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
264644|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
264645|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
264646|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
264647|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
264648|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
264649|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
264650|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
264651|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
264652|NCT01180998|E3|Reported Event|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses will use one of two toric lenses in a daily wear modality.
264653|NCT01180998|E2|Reported Event|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, will use one of two toric lenses in a daily wear modality.
264654|NCT01180998|E1|Reported Event|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users will use one of two toric lenses in a daily wear modality.
264655|NCT01180985|B1|Baseline|All Subjects|All enrolled subjects at baseline.
264656|NCT01180985|P2|Participant Flow|Comfilcon A (Control)/Galyfilcon A (Test)|Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
264657|NCT01180985|P1|Participant Flow|Galyfilcon A (Test)/Comfilcon A (Control)|Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
264658|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All subjects who wore galyfilcon A lenses
264659|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All subjects who wore comfilcon A lenses
264660|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
264661|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
264662|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
264663|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
264664|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
264665|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
264666|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
264667|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
264668|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
264669|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
264670|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
264671|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
264672|NCT01180985|E1|Reported Event|Galyfilcon A Prototype/Comfilcon A|All enrolled subjects were to wear both lenses through the course of the study.
264673|NCT01180894|B3|Baseline|Total|Total of all reporting groups
264674|NCT01180894|B2|Baseline|Placebo|"Placebo
100 mg Normal saline"
264675|NCT01180894|B1|Baseline|Iron Sucrose|"100 mg IV TIW
Iron sucrose: 100 mg IV TIW"
264676|NCT01180894|P2|Participant Flow|Placebo|Placebo (100 mg normal saline)
264677|NCT01180894|P1|Participant Flow|Iron Sucrose|"100 mg IV TIW
Iron sucrose: 100 mg IV TIW"
264678|NCT01180894|O2|Outcome|Placebo|Placebo (100 mg normal saline)
264679|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW
Iron sucrose: 100 mg IV TIW"
264680|NCT01180894|O2|Outcome|Placebo|Placebo (100 mg normal saline)
264681|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW
Iron sucrose: 100 mg IV TIW"
264682|NCT01180894|O2|Outcome|Placebo|"Placebo
100 mg Normal saline"
264683|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW
Iron sucrose: 100 mg IV TIW"
264684|NCT01180894|O2|Outcome|Placebo|"Pacebo - Normal Saline
Placebo"
264685|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW
Iron sucrose: 100 mg IV TIW"
264686|NCT01180894|E2|Reported Event|Placebo|"Placebo
100 mg Normal saline"
264687|NCT01180894|E1|Reported Event|Iron Sucrose|"100 mg IV TIW
Iron sucrose: 100 mg IV TIW"
264688|NCT01180790|B8|Baseline|Total|Total of all reporting groups
264689|NCT01180790|B7|Baseline|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264690|NCT01180790|B6|Baseline|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264691|NCT01180790|B5|Baseline|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264692|NCT01180790|B4|Baseline|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily for 28 days
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264693|NCT01180790|B3|Baseline|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264694|NCT01180790|B2|Baseline|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264695|NCT01180790|B1|Baseline|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264696|NCT01180790|P7|Participant Flow|Segment 2 - 800 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
264697|NCT01180790|P6|Participant Flow|Segment 2 - 400 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
264698|NCT01180790|P5|Participant Flow|Segment 2: 200 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
264699|NCT01180790|P4|Participant Flow|Segment 1: Placebo for 28 Days|"Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264700|NCT01180790|P3|Participant Flow|Segment 1: 800 mg ACH-0141625 for 28 Days|"ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264701|NCT01180790|P2|Participant Flow|Segment 1: 400 mg ACH-0141625 for 28 Days|"ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264702|NCT01180790|P1|Participant Flow|Segment 1: 200 mg ACH-0141625 for 28 Days|"ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264703|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264704|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264705|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264706|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily for 28 days
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264707|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264708|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
312791|NCT00236197|B3|Baseline|Total|Total of all reporting groups
264709|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264710|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264711|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264712|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264713|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily for 28 days
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264714|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264715|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264716|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264717|NCT01180790|O7|Outcome|Segment 2 : 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264718|NCT01180790|O6|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264719|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264720|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily for 28 days
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264721|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264722|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264723|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264724|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264725|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264726|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily for
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264727|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
265540|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
264728|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264729|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264730|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264731|NCT01180790|O7|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264732|NCT01180790|O6|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264733|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264734|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264735|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264736|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264737|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264738|NCT01180790|O3|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264739|NCT01180790|O2|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264740|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264741|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264742|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264743|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264744|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264745|NCT01180790|O3|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
Ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264746|NCT01180790|O2|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
Ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264747|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264777|NCT01180777|E1|Reported Event|All Subjects|Subjects were to wear all three lenses over the course of the study. Due to the non-ocular related AE, all subjects are summarized to report the occurrence of event.
264778|NCT01180660|B3|Baseline|Total|Total of all reporting groups
264748|NCT01180790|O3|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for up to 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264749|NCT01180790|O2|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for up to 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264750|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264751|NCT01180790|O4|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264752|NCT01180790|O3|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264753|NCT01180790|O2|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264754|NCT01180790|O1|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264755|NCT01180790|O4|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264756|NCT01180790|O3|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264757|NCT01180790|O2|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264758|NCT01180790|O1|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264759|NCT01180790|E7|Reported Event|Segment 1 - Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264760|NCT01180790|E6|Reported Event|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264761|NCT01180790|E5|Reported Event|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264762|NCT01180790|E4|Reported Event|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264763|NCT01180790|E3|Reported Event|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264764|NCT01180790|E2|Reported Event|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
264765|NCT01180790|E1|Reported Event|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
264766|NCT01180777|B1|Baseline|All Subjects|Subjects were to wear all three lenses over the course of the study.
264767|NCT01180777|P1|Participant Flow|All Subjects|All subjects who enrolled, randomized, and exposed to the study lenses. Subjects where randomized to a study arm and wore all three of the study lenses by study completion. Randomization was to the arms as outlined in the 'arms' section of the protocol.
264768|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
264769|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
264770|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
264771|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
264772|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
264773|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
264774|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
264775|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
264779|NCT01180660|B2|Baseline|Placebo|"Placebo Normal Saline Infusion
Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
264780|NCT01180660|B1|Baseline|Lidocaine|"Lidocaine infusion
Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
264781|NCT01180660|P2|Participant Flow|Placebo|"Placebo Normal Saline Infusion
Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
264782|NCT01180660|P1|Participant Flow|Lidocaine|"Lidocaine infusion
Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
264783|NCT01180660|O2|Outcome|Placebo|"Placebo Normal Saline Infusion
Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
264784|NCT01180660|O1|Outcome|Lidocaine|"Lidocaine infusion
Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
264785|NCT01180660|O2|Outcome|Placebo|"Placebo Normal Saline Infusion
Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
264786|NCT01180660|O1|Outcome|Lidocaine|"Lidocaine infusion
Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
264787|NCT01180660|E2|Reported Event|Placebo|"Placebo Normal Saline Infusion
Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
264788|NCT01180660|E1|Reported Event|Lidocaine|"Lidocaine infusion
Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
264789|NCT01180647|B3|Baseline|Total|Total of all reporting groups
264790|NCT01180647|B2|Baseline|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
264791|NCT01180647|B1|Baseline|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
264792|NCT01180647|P2|Participant Flow|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
264793|NCT01180647|P1|Participant Flow|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
264794|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
264795|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
264796|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
264797|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
264798|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
264799|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
264800|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
264801|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
264837|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264802|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
264803|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
264804|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
264805|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
264806|NCT01180647|E2|Reported Event|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
264807|NCT01180647|E1|Reported Event|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
264808|NCT01180400|B3|Baseline|Total|Total of all reporting groups
264809|NCT01180400|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264810|NCT01180400|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264811|NCT01180400|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264812|NCT01180400|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264813|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264814|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264815|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264816|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264817|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264818|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264819|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264820|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264821|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264822|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264823|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264824|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264825|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264826|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264827|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264828|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264829|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264830|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264831|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264832|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264833|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264834|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264835|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264836|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
265541|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
264838|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264839|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264840|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264841|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264842|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264843|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264844|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264845|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264846|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264847|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264848|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264849|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264850|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264851|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264852|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264853|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264854|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264855|NCT01180400|E2|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
264856|NCT01180400|E1|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
264857|NCT01180296|B3|Baseline|Total|Total of all reporting groups
264858|NCT01180296|B2|Baseline|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
264859|NCT01180296|B1|Baseline|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
264860|NCT01180296|P2|Participant Flow|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
264861|NCT01180296|P1|Participant Flow|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
264862|NCT01180296|O2|Outcome|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
264863|NCT01180296|O1|Outcome|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
264864|NCT01180296|E2|Reported Event|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
264865|NCT01180296|E1|Reported Event|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
264866|NCT01180244|B3|Baseline|Total|Total of all reporting groups
264867|NCT01180244|B2|Baseline|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
264868|NCT01180244|B1|Baseline|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
264869|NCT01180244|P2|Participant Flow|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
264870|NCT01180244|P1|Participant Flow|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
264871|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
264969|NCT00000371|E2|Reported Event|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
264872|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
264873|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
264874|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
264875|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
264876|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
264877|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
264878|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
264879|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
264880|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
264881|NCT01180244|E2|Reported Event|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
264882|NCT01180244|E1|Reported Event|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
264883|NCT01180127|B5|Baseline|Total|Total of all reporting groups
264884|NCT01180127|B4|Baseline|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavanol containing food product
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264885|NCT01180127|B3|Baseline|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavanol
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
264886|NCT01180127|B2|Baseline|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264887|NCT01180127|B1|Baseline|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
264888|NCT01180127|P4|Participant Flow|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264889|NCT01180127|P3|Participant Flow|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
264890|NCT01180127|P2|Participant Flow|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264891|NCT01180127|P1|Participant Flow|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
264892|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264893|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
264894|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264895|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
264896|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264897|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
264898|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264899|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
264900|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavonol containing food product
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264901|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavonol
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol"
264902|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavonol containing food product for 12 weeks
Flavonol containing food product: 12 weeks, 2X/day, 20g serving
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264903|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavonol containing food product
Flavonol containing food product: 12 weeks, 2X/day, 20g serving
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
264904|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264905|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
264906|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264907|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
264908|NCT01180127|E4|Reported Event|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavanol containing food product
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264909|NCT01180127|E3|Reported Event|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavanol
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR
Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
264910|NCT01180127|E2|Reported Event|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
264911|NCT01180127|E1|Reported Event|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product
Flavanol containing food product: 12 weeks, 2X/day, 20g serving
Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
264912|NCT01180049|B3|Baseline|Total|Total of all reporting groups
264913|NCT01180049|B2|Baseline|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
264970|NCT00000371|E1|Reported Event|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
264914|NCT01180049|B1|Baseline|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
264915|NCT01180049|P2|Participant Flow|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
264916|NCT01180049|P1|Participant Flow|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
264917|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
264918|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
264919|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
264920|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
264921|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
264922|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
264923|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
264924|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
264925|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
264926|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
264927|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
264928|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
264929|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
264930|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
264931|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
264932|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
264933|NCT01180049|E2|Reported Event|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
264971|NCT00000378|B3|Baseline|Total|Total of all reporting groups
264972|NCT00000378|B2|Baseline|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level
Nortriptyline: 12 week trial dose adjusted to therapeutic level"
264934|NCT01180049|E1|Reported Event|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
264935|NCT01179984|B1|Baseline|Single-Arm|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
264936|NCT01179984|P1|Participant Flow|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
264937|NCT01179984|O1|Outcome|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
264938|NCT01179984|O1|Outcome|Single-Arm|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
264939|NCT01179984|O1|Outcome|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
264940|NCT01179984|E1|Reported Event|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
264941|NCT01179919|B1|Baseline|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses
Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
264942|NCT01179919|P1|Participant Flow|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses
Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
264943|NCT01179919|O1|Outcome|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses
Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
264944|NCT01179919|O1|Outcome|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses
Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
264945|NCT01179919|E1|Reported Event|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses
Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
264946|NCT01179737|B5|Baseline|Total|Total of all reporting groups
264947|NCT01179737|B4|Baseline|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
264948|NCT01179737|B3|Baseline|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
264949|NCT01179737|B2|Baseline|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
264950|NCT01179737|B1|Baseline|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
264951|NCT01179737|P4|Participant Flow|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
264952|NCT01179737|P3|Participant Flow|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
264953|NCT01179737|P2|Participant Flow|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
264954|NCT01179737|P1|Participant Flow|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
264955|NCT01179737|O1|Outcome|Total Number of Adverse Events and Serious Adverse Events|Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section.
264956|NCT01179737|O1|Outcome|Change in Pulmonary Vascular Resistance (PVR)|"Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR).
Additional information about the outcome measure, if needed for clarification. Outcome Measures are: Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
Examples:
Title: all cause mortality Time Frame: one year Safety Issue: No
Title: Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI Time Frame: within the first 30 days (plus or minus 3 days) after surgery Safety Issue: Yes"
264957|NCT01179737|O1|Outcome|Change in Six-Minute Walk Distance (6MWD) From Baseline|During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minu
264958|NCT01179737|E4|Reported Event|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
264959|NCT01179737|E3|Reported Event|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
264960|NCT01179737|E2|Reported Event|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
264961|NCT01179737|E1|Reported Event|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
264962|NCT00000371|B3|Baseline|Total|Total of all reporting groups
264963|NCT00000371|B2|Baseline|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
264964|NCT00000371|B1|Baseline|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
264965|NCT00000371|P2|Participant Flow|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
264966|NCT00000371|P1|Participant Flow|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
264967|NCT00000371|O2|Outcome|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
264968|NCT00000371|O1|Outcome|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
312792|NCT00236197|B2|Baseline|Rabeprazole 10 mg|
264973|NCT00000378|B1|Baseline|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs
Sertraline: 12 week trial dose up to 200mgs"
264974|NCT00000378|P2|Participant Flow|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level
Nortriptyline: 12 week trial dose adjusted to therapeutic level"
264975|NCT00000378|P1|Participant Flow|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs
Sertraline: 12 week trial dose up to 200mgs"
264976|NCT00000378|O2|Outcome|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level
Nortriptyline: 12 week trial dose adjusted to therapeutic level"
264977|NCT00000378|O1|Outcome|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs
Sertraline: 12 week trial dose up to 200mgs"
264978|NCT00000378|E2|Reported Event|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level
Nortriptyline: 12 week trial dose adjusted to therapeutic level"
264979|NCT00000378|E1|Reported Event|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs
Sertraline: 12 week trial dose up to 200mgs"
264980|NCT00000392|B3|Baseline|Total|Total of all reporting groups
264981|NCT00000392|B2|Baseline|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months
Placebo"
264982|NCT00000392|B1|Baseline|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months
Peptide T"
264983|NCT00000392|P2|Participant Flow|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months
Placebo"
264984|NCT00000392|P1|Participant Flow|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months
Peptide T"
264985|NCT00000392|O2|Outcome|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months
Placebo"
264986|NCT00000392|O1|Outcome|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months
Peptide T"
264987|NCT00000392|O2|Outcome|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months
Placebo"
264988|NCT00000392|O1|Outcome|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months
Peptide T"
264989|NCT00000392|E2|Reported Event|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months
Placebo"
264990|NCT00000392|E1|Reported Event|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months
Peptide T"
264991|NCT00000575|B4|Baseline|Total|Total of all reporting groups
264992|NCT00000575|B3|Baseline|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
264993|NCT00000575|B2|Baseline|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
264994|NCT00000575|B1|Baseline|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
264995|NCT00000575|P3|Participant Flow|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
264996|NCT00000575|P2|Participant Flow|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
264997|NCT00000575|P1|Participant Flow|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
264998|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
264999|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
265000|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
265001|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
265002|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
265003|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
265004|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
265005|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
265006|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
265007|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
265008|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
265009|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
265010|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
265011|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
265012|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
265013|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
265014|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
265015|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
265016|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
265017|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
312793|NCT00236197|B1|Baseline|Placebo|
265018|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
265019|NCT00000575|E3|Reported Event|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
265020|NCT00000575|E2|Reported Event|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
265021|NCT00000575|E1|Reported Event|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
265022|NCT00000620|B3|Baseline|Total|Total of all reporting groups
265023|NCT00000620|B2|Baseline|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
265024|NCT00000620|B1|Baseline|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
265025|NCT00000620|P8|Participant Flow|Glycemia Trial: Standard Control/Lipid Trial: Placebo|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
265026|NCT00000620|P7|Participant Flow|Glycemia Trial: Standard Control/Lipid Trial: Fenofibrate|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
265027|NCT00000620|P6|Participant Flow|Glycemia Trial: Standard Control/BP Trial: Standard Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg)."
265028|NCT00000620|P5|Participant Flow|Glycemia Trial: Standard Control/BP Trial: Intensive Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
265029|NCT00000620|P4|Participant Flow|Glycemia Trial: Intensive Control/Lipid Trial: Placebo|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
265030|NCT00000620|P3|Participant Flow|Glycemia Trial: Intensive Control/Lipid Trial: Fenofibrate|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
265057|NCT00000134|B3|Baseline|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
312794|NCT00236197|P2|Participant Flow|Rabeprazole 10 mg|
265031|NCT00000620|P2|Participant Flow|Glycemia Trial: Intensive Control/BP Trial: Standard Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
265032|NCT00000620|P1|Participant Flow|Glycemia Trial: Intensive Control/BP Trial: Intensive Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
265033|NCT00000620|O2|Outcome|Lipid Trial: Placebo|Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
265034|NCT00000620|O1|Outcome|Lipid Trial: Fenofibrate|Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
265035|NCT00000620|O2|Outcome|Lipid Trial: Placebo|Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
265036|NCT00000620|O1|Outcome|Lipid Trial: Fenofibrate|Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
265037|NCT00000620|O2|Outcome|BP Trial: Standard Control|Open label administration of multiple anti-hypertensive agents to maintain SBP level to <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals.
265038|NCT00000620|O1|Outcome|BP Trial: Intensive Control|Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals.
265039|NCT00000620|O2|Outcome|BP Trial: Standard Control|Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals.
265040|NCT00000620|O1|Outcome|BP Trial: Intensive Control|Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals.
265041|NCT00000620|O2|Outcome|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
265042|NCT00000620|O1|Outcome|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
265043|NCT00000620|O2|Outcome|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
265044|NCT00000620|O1|Outcome|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
265045|NCT00000620|E2|Reported Event|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
265046|NCT00000620|E1|Reported Event|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
265047|NCT00000125|B3|Baseline|Total|Total of all reporting groups
265048|NCT00000125|B2|Baseline|Treatment|Topical Antiglaucoma Agents: Topical Antiglaucoma Agents
265049|NCT00000125|B1|Baseline|Observation|Observation only
265050|NCT00000125|P2|Participant Flow|Treatment|Topical ocular hypotensive eye drops.
265051|NCT00000125|P1|Participant Flow|Observation|Close Observation
265052|NCT00000125|O2|Outcome|Treatment|Topical ocular hypotensive eye drops from February 1994 through March 2009.
265053|NCT00000125|O1|Outcome|Observation|Observation only from February 1994 through June 2002.Observation participants were offered topical antiglaucoma agents after June 2002 through study close out March 2009.
265054|NCT00000125|E2|Reported Event|Treatment|Topical Antiglaucoma Agents: Topical Antiglaucoma Agents from February 1994 to June 2002.
265055|NCT00000125|E1|Reported Event|Observation|Observation only from February 1994 to June 2002 .
265056|NCT00000134|B4|Baseline|Total|Total of all reporting groups
265058|NCT00000134|B2|Baseline|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
265059|NCT00000134|B1|Baseline|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
265060|NCT00000134|P3|Participant Flow|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
265061|NCT00000134|P2|Participant Flow|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
265062|NCT00000134|P1|Participant Flow|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
265063|NCT00000134|O3|Outcome|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
265064|NCT00000134|O2|Outcome|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
265065|NCT00000134|O1|Outcome|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
265066|NCT00000134|E3|Reported Event|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
265067|NCT00000134|E2|Reported Event|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
265068|NCT00000134|E1|Reported Event|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
265069|NCT00000135|B3|Baseline|Total|Total of all reporting groups
265070|NCT00000135|B2|Baseline|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
265071|NCT00000135|B1|Baseline|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
265072|NCT00000135|P2|Participant Flow|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
265073|NCT00000135|P1|Participant Flow|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
265074|NCT00000135|O2|Outcome|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
265075|NCT00000135|O1|Outcome|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
265076|NCT00000135|E2|Reported Event|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
265077|NCT00000135|E1|Reported Event|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
265078|NCT00000136|B3|Baseline|Total|Total of all reporting groups
265079|NCT00000136|B2|Baseline|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
265080|NCT00000136|B1|Baseline|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
265081|NCT00000136|P2|Participant Flow|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
265082|NCT00000136|P1|Participant Flow|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
265083|NCT00000136|O2|Outcome|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
265317|NCT00001941|P4|Participant Flow|Phase I - 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
265084|NCT00000136|O1|Outcome|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
265085|NCT00000136|E2|Reported Event|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
265086|NCT00000136|E1|Reported Event|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
265087|NCT00000142|B4|Baseline|Total|Total of all reporting groups
265088|NCT00000142|B3|Baseline|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265089|NCT00000142|B2|Baseline|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265090|NCT00000142|B1|Baseline|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265091|NCT00000142|P3|Participant Flow|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265092|NCT00000142|P2|Participant Flow|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265093|NCT00000142|P1|Participant Flow|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265094|NCT00000142|O3|Outcome|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265095|NCT00000142|O2|Outcome|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265096|NCT00000142|O1|Outcome|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265097|NCT00000142|E3|Reported Event|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265098|NCT00000142|E2|Reported Event|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265782|NCT00003377|E5|Reported Event|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
265099|NCT00000142|E1|Reported Event|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
265100|NCT00000143|B3|Baseline|Total|Total of all reporting groups
265101|NCT00000143|B2|Baseline|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
265102|NCT00000143|B1|Baseline|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
265103|NCT00000143|P2|Participant Flow|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
265104|NCT00000143|P1|Participant Flow|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
265105|NCT00000143|O2|Outcome|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
265106|NCT00000143|O1|Outcome|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
265107|NCT00000143|E2|Reported Event|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
265108|NCT00000143|E1|Reported Event|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
265109|NCT00000479|B5|Baseline|Total|Total of all reporting groups
265110|NCT00000479|B4|Baseline|Both Placebos|Placebo aspirin and placebo vitamin E
265111|NCT00000479|B3|Baseline|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
265112|NCT00000479|B2|Baseline|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
265113|NCT00000479|B1|Baseline|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
265114|NCT00000479|P4|Participant Flow|Both Placebos|Placebo aspirin and placebo vitamin E
265115|NCT00000479|P3|Participant Flow|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
265116|NCT00000479|P2|Participant Flow|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
265117|NCT00000479|P1|Participant Flow|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
265118|NCT00000479|O4|Outcome|Both Placebos|Placebo aspirin and placebo vitamin E
265119|NCT00000479|O3|Outcome|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
265120|NCT00000479|O2|Outcome|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
265121|NCT00000479|O1|Outcome|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
265122|NCT00000479|O4|Outcome|Both Placebos|Placebo aspirin and placebo vitamin E
265123|NCT00000479|O3|Outcome|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
265124|NCT00000479|O2|Outcome|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
265125|NCT00000479|O1|Outcome|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
265126|NCT00000479|E4|Reported Event|Both Placebos|Placebo aspirin and placebo vitamin E
265127|NCT00000479|E3|Reported Event|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
265128|NCT00000479|E2|Reported Event|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
265129|NCT00000479|E1|Reported Event|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
265130|NCT00001151|B1|Baseline|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
265131|NCT00001151|P1|Participant Flow|Group 1|Patient has rickets (child) or osteomalacia (adult) of bone
265132|NCT00001151|O1|Outcome|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
265133|NCT00001151|E1|Reported Event|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
265134|NCT00001213|B1|Baseline|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes
Cysteamine"
265135|NCT00001213|P1|Participant Flow|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes
Cysteamine"
265136|NCT00001213|O1|Outcome|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes
Cysteamine"
265137|NCT00001213|O1|Outcome|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes
Cysteamine"
265138|NCT00001213|E1|Reported Event|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes
Cysteamine"
265139|NCT00001262|B4|Baseline|Total|Total of all reporting groups
265140|NCT00001262|B3|Baseline|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
265141|NCT00001262|B2|Baseline|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
265142|NCT00001262|B1|Baseline|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
265143|NCT00001262|P3|Participant Flow|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
312795|NCT00236197|P1|Participant Flow|Placebo|
265144|NCT00001262|P2|Participant Flow|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
265145|NCT00001262|P1|Participant Flow|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
265146|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
265147|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
265148|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
265149|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
265150|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
265151|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
265152|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
265153|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
265154|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
265155|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
265156|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
265157|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
265158|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
265159|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
265160|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
265161|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
265162|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
265163|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
265164|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
265165|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
265166|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
265167|NCT00001262|E3|Reported Event|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
265168|NCT00001262|E2|Reported Event|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
265169|NCT00001262|E1|Reported Event|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
265170|NCT00001304|B3|Baseline|Total|Total of all reporting groups
265171|NCT00001304|B2|Baseline|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
265172|NCT00001304|B1|Baseline|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
265173|NCT00001304|P2|Participant Flow|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
265174|NCT00001304|P1|Participant Flow|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
265175|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
265176|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
265177|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
265178|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
265179|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
265180|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
265181|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
265182|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
265183|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
265184|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
265185|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
265186|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
265187|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
265188|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
265189|NCT00001304|E2|Reported Event|Calcitriol & Calcium|"All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.
Calcitriol & Calcium"
265190|NCT00001304|E1|Reported Event|PTH 1-34|"All patients received twice daily synthetic Human Parathyroid Hormone 1-34.
PTH 1-34"
265191|NCT00001566|B1|Baseline|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265192|NCT00001566|P1|Participant Flow|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265193|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265194|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265195|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265196|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265197|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265198|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265199|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265200|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265201|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265202|NCT00001566|E1|Reported Event|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
265203|NCT00001575|B1|Baseline|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
265204|NCT00001575|P1|Participant Flow|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
265205|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
265206|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
265207|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
265208|NCT00001575|E1|Reported Event|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
265209|NCT00001586|B3|Baseline|Total|Total of all reporting groups
265210|NCT00001586|B2|Baseline|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
265211|NCT00001586|B1|Baseline|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
265212|NCT00001586|P2|Participant Flow|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered. Eligible to donate cells.
265318|NCT00001941|P3|Participant Flow|Phase I - 6 mg/kg Cohort|6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
265213|NCT00001586|P1|Participant Flow|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
265214|NCT00001586|O2|Outcome|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
265215|NCT00001586|O1|Outcome|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
265216|NCT00001586|O2|Outcome|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
265217|NCT00001586|O1|Outcome|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
265218|NCT00001586|E2|Reported Event|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
265219|NCT00001586|E1|Reported Event|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
265220|NCT00001596|B3|Baseline|Total|Total of all reporting groups
265221|NCT00001596|B2|Baseline|Placebo|Subjects received placebo (3 pills), three times daily.
265222|NCT00001596|B1|Baseline|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
265223|NCT00001596|P2|Participant Flow|Placebo|Subjects received placebo (3 pills), three times daily.
265224|NCT00001596|P1|Participant Flow|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
265225|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
265226|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
265227|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
265228|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
265229|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
265230|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
265231|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
265232|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
265233|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
265234|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
265235|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
265236|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
265237|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
265238|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
265239|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
265240|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
265241|NCT00001596|E2|Reported Event|Placebo|Subjects received placebo (3 pills), three times daily.
265242|NCT00001596|E1|Reported Event|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
265243|NCT00001832|B15|Baseline|Total|Total of all reporting groups
265244|NCT00001832|B14|Baseline|Cells IV + SQ IL-2 w/GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF in patients with no reactivity
265245|NCT00001832|B13|Baseline|Cells IV + SQ IL-2 w/GCSF (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265246|NCT00001832|B12|Baseline|Cells IV + SQ IL-2 w/GCSF|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF (to shorten time to neutrophil recovery), reactivity not specified
265247|NCT00001832|B11|Baseline|Cells IV + MTD IL-2 no GCSF (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265248|NCT00001832|B10|Baseline|Cells IV + MTD IL-2 no GCSF (gp100 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
265249|NCT00001832|B9|Baseline|Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
265250|NCT00001832|B8|Baseline|Cells IA + MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265251|NCT00001832|B7|Baseline|Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF
265252|NCT00001832|B6|Baseline|Cells IA + MTD IL-2 (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + G-CSF
265253|NCT00001832|B5|Baseline|Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF (to shorten time to neutrophil recovery)
265254|NCT00001832|B4|Baseline|Cells IV + High-Dose IV IL-2 (Initial)|Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
265255|NCT00001832|B3|Baseline|Cells IV + Low-Dose IV IL-2 (Initial)|Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
265256|NCT00001832|B2|Baseline|Cells IV + Cyclophosphamide 60mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV
265257|NCT00001832|B1|Baseline|Cells IV + Cyclophosphamide 30mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x30mg/kg + Cells IV
265258|NCT00001832|P15|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
265259|NCT00001832|P14|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265260|NCT00001832|P13|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
265261|NCT00001832|P12|Participant Flow|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265262|NCT00001832|P11|Participant Flow|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
265263|NCT00001832|P10|Participant Flow|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
265264|NCT00001832|P9|Participant Flow|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265265|NCT00001832|P8|Participant Flow|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
265266|NCT00001832|P7|Participant Flow|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
265267|NCT00001832|P6|Participant Flow|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
265268|NCT00001832|P5|Participant Flow|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
265269|NCT00001832|P4|Participant Flow|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
265270|NCT00001832|P3|Participant Flow|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
265271|NCT00001832|P2|Participant Flow|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
265272|NCT00001832|P1|Participant Flow|Abl Cells in Culture|Peripheral blood mononuclear cells (PBMC) and/or tumor infiltrating lymphocytes (TIL) obtained by apheresis or lesion excision to be cloned and expanded in the lab. All patients were enrolled on Arm 0 and their cells were then sent to the lab. If the lab was able to manufacture the cell product then the patient was enrolled on one of the treatment arms.
265273|NCT00001832|O14|Outcome|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
265274|NCT00001832|O13|Outcome|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265275|NCT00001832|O12|Outcome|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
265276|NCT00001832|O11|Outcome|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265277|NCT00001832|O10|Outcome|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
265278|NCT00001832|O9|Outcome|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
265279|NCT00001832|O8|Outcome|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265280|NCT00001832|O7|Outcome|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
265281|NCT00001832|O6|Outcome|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
265282|NCT00001832|O5|Outcome|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
265283|NCT00001832|O4|Outcome|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
265284|NCT00001832|O3|Outcome|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
265285|NCT00001832|O2|Outcome|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
265286|NCT00001832|O1|Outcome|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
265287|NCT00001832|O14|Outcome|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
265288|NCT00001832|O13|Outcome|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265289|NCT00001832|O12|Outcome|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
265290|NCT00001832|O11|Outcome|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265291|NCT00001832|O10|Outcome|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
265292|NCT00001832|O9|Outcome|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
265293|NCT00001832|O8|Outcome|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
312796|NCT00236197|O2|Outcome|Rabeprazole 10 mg|
265294|NCT00001832|O7|Outcome|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
265295|NCT00001832|O6|Outcome|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
265296|NCT00001832|O5|Outcome|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
265297|NCT00001832|O4|Outcome|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
265298|NCT00001832|O3|Outcome|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
265299|NCT00001832|O2|Outcome|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
265300|NCT00001832|O1|Outcome|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
265301|NCT00001832|E14|Reported Event|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
265302|NCT00001832|E13|Reported Event|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with granulocyte colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265303|NCT00001832|E12|Reported Event|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + granulocyte colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
265304|NCT00001832|E11|Reported Event|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265305|NCT00001832|E10|Reported Event|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
265306|NCT00001832|E9|Reported Event|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
265307|NCT00001832|E8|Reported Event|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
265308|NCT00001832|E7|Reported Event|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
265309|NCT00001832|E6|Reported Event|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
265310|NCT00001832|E5|Reported Event|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
265311|NCT00001832|E4|Reported Event|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
265312|NCT00001832|E3|Reported Event|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
265313|NCT00001832|E2|Reported Event|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
265314|NCT00001832|E1|Reported Event|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
265315|NCT00001941|B1|Baseline|Phase I & II Cohorts (2-8 mg/kg)|Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
265316|NCT00001941|P5|Participant Flow|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
265783|NCT00003377|E4|Reported Event|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
265321|NCT00001941|O1|Outcome|Phase I & II Cohorts (2-8 mg/kg)|Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
265322|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
265323|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
265324|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
265325|NCT00001941|E1|Reported Event|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
265326|NCT00001959|B1|Baseline|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
265327|NCT00001959|P1|Participant Flow|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
265328|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
265329|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
265330|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
265331|NCT00001959|E1|Reported Event|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
265332|NCT00001962|B1|Baseline|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period. The Diamond Blackfan anemia arm was closed due to lack of accrual.
265333|NCT00001962|P1|Participant Flow|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period.The Diamond Blackfan anemia arm was closed due to lack of accrual.
265334|NCT00001962|O1|Outcome|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions to subjects diagnosed with moderate aplastic anemia (MAA), pure red cell aplasia (PRCA), Diamond Blackfan anemia (DBA), relapse and refractory severe aplastic anemia (SAA) will receive treatment.
265335|NCT00001962|E1|Reported Event|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period. The Diamond Blackfan anemia arm was closed due to lack of accrual.
265336|NCT00001984|B1|Baseline|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
265337|NCT00001984|P1|Participant Flow|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
265338|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
265339|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
265340|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
265341|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
265542|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
265342|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
265343|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
265344|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
265345|NCT00001984|E1|Reported Event|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
265346|NCT00002525|B3|Baseline|Total|Total of all reporting groups
265347|NCT00002525|B2|Baseline|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265348|NCT00002525|B1|Baseline|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265349|NCT00002525|P2|Participant Flow|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265350|NCT00002525|P1|Participant Flow|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265351|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265352|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265353|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265354|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265355|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265356|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265357|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265381|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265382|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
265358|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265359|NCT00002525|E4|Reported Event|Adjuvant Chemotherapy-- 5-FU+Leucovovin|"After surgery, patients with stage IIC or III disease enrolled between August 1993 and August 1997 receive the following adjuvant chemotherapy:
Levamisole: 50 mg PO TID Days 1-3 and Days 15-17; 50 mg PO TID x 3 days beginning Day 29, repeat every 14 days for 11 months.
5-FU: 450 mg/m²/day IV bolus for Days 1-5. 450 mg/m² IV bolus once weekly beginning Day 29, repeat weekly for a maximum of 11 months.
All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis."
265360|NCT00002525|E3|Reported Event|Adjuvant Chemotherapy-- 5-FU+Levamisolem|"Beginning 21-35 days after surgery, patients with stage IIC or III disease enrolled between September 1997 and May 2000 receive the following adjuvant chemotherapy:
Leucovorin: 20 mg/m² IV push days 1-5 5-FU: 425 mg/m² IV push days 1-5, give immediately after Leucovorin
A cycle of therapy consisted of 5 consecutive days of chemotherapy. Cycles were repeated at the end of 4 weeks (day 29), 8 weeks (day 57) and then every 4 weeks for a total of 6 cycles.
All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis."
265361|NCT00002525|E2|Reported Event|Arm II (No Perioperative 5-FU)|"Patients receive no perioperative fluorouracil.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265362|NCT00002525|E1|Reported Event|Arm I (Perioperative 5-FU)|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.
After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5
fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5
leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
265363|NCT00002540|B3|Baseline|Total|Total of all reporting groups
265364|NCT00002540|B2|Baseline|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265365|NCT00002540|B1|Baseline|Control|Participants receive standard medical care.
265366|NCT00002540|P2|Participant Flow|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265367|NCT00002540|P1|Participant Flow|Control|Participants receive standard medical care.
265368|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265369|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265370|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265371|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
265372|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265373|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265374|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265375|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265376|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265377|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265378|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265379|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265380|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265543|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
312797|NCT00236197|O1|Outcome|Placebo|
265383|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265384|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
265385|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265386|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
265387|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265388|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
265389|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265390|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
265391|NCT00002540|E1|Reported Event|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
265392|NCT00002558|B3|Baseline|Total|Total of all reporting groups
265393|NCT00002558|B2|Baseline|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
265394|NCT00002558|B1|Baseline|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
265395|NCT00002558|P2|Participant Flow|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
265396|NCT00002558|P1|Participant Flow|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
265397|NCT00002558|O2|Outcome|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
265398|NCT00002558|O1|Outcome|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
265399|NCT00002558|E2|Reported Event|Group: B > 6 Cycles of Cisplatin|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
265400|NCT00002558|E1|Reported Event|Group A: <= 6 Cycles of Cisplatin|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
265401|NCT00002597|B3|Baseline|Total|Total of all reporting groups
265402|NCT00002597|B2|Baseline|Radiation Therapy Alone|Radiation therapy alone
265403|NCT00002597|B1|Baseline|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
265404|NCT00002597|P2|Participant Flow|Radiation Therapy Alone|Radiation therapy alone
265405|NCT00002597|P1|Participant Flow|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
265406|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
265407|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
265408|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
265409|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
265410|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
265411|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
265412|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
265413|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
265414|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
265415|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
265416|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
265417|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
265418|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
265419|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
265420|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
265421|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
265422|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
265423|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
265424|NCT00002597|E2|Reported Event|Radiation Therapy Alone|Radiation therapy alone
265425|NCT00002597|E1|Reported Event|Neoadjuvant TAS 2 Months Before and During RT|Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy
265426|NCT00002601|B1|Baseline|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
265544|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
265545|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
312798|NCT00236197|E2|Reported Event|Rabeprazole 10 mg|
265427|NCT00002601|P1|Participant Flow|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
265428|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
265429|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
265430|NCT00002601|O2|Outcome|Cycle 2|Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
265431|NCT00002601|O1|Outcome|Cycle 1|Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
265432|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
265433|NCT00002601|E1|Reported Event|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
265434|NCT00002651|B3|Baseline|Total|Total of all reporting groups
265435|NCT00002651|B2|Baseline|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
265436|NCT00002651|B1|Baseline|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
265437|NCT00002651|P3|Participant Flow|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
265438|NCT00002651|P2|Participant Flow|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
265439|NCT00002651|P1|Participant Flow|Combined Androgen Deprivation (CAD)|Patients receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily for 7 months.
265440|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
265441|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
265442|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
265443|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
265459|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265444|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
265445|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
265446|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
265447|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
265448|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
265449|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
265450|NCT00002651|O2|Outcome|Consolidation Arm II|"Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy as in consolidation arm I. Patients whose PSA normalizes after 8 courses return to observation. Patients whose PSA does not normalize after 8 courses continue CAD therapy.
bicalutamide: Given orally
goserelin acetate: Given subcutaneously
clinical observation: Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease."
265451|NCT00002651|O1|Outcome|Consolidation Arm I|"Patients continue CAD therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily. Treatment continues in the absence of disease progression.
bicalutamide: Given orally
goserelin acetate: Given subcutaneously"
265452|NCT00002651|E2|Reported Event|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
265453|NCT00002651|E1|Reported Event|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
265454|NCT00001656|B3|Baseline|Total|Total of all reporting groups
265455|NCT00001656|B2|Baseline|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265456|NCT00001656|B1|Baseline|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265457|NCT00001656|P2|Participant Flow|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265458|NCT00001656|P1|Participant Flow|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265514|NCT00002766|O2|Outcome|L-20|"Standard Vincristine/Prednisone (L-20)"
265515|NCT00002766|O1|Outcome|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
312799|NCT00236197|E1|Reported Event|Placebo|
265460|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265461|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265462|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265463|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265464|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265465|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265466|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265467|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265468|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265469|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265470|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265471|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265516|NCT00002766|E2|Reported Event|L-20|"Standard Vincristine/Prednisone (L-20)"
265517|NCT00002766|E1|Reported Event|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
265546|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
265547|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
265472|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265473|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265474|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265475|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265476|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265477|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265478|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265479|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265480|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265481|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265482|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265483|NCT00001656|E2|Reported Event|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265536|NCT00002874|B2|Baseline|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
265537|NCT00002874|B1|Baseline|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
265538|NCT00002874|P2|Participant Flow|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
265784|NCT00003377|E3|Reported Event|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
265484|NCT00001656|E1|Reported Event|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
265485|NCT00001703|B1|Baseline|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
265486|NCT00001703|P1|Participant Flow|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
265487|NCT00001703|O1|Outcome|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
265488|NCT00001703|O1|Outcome|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
265489|NCT00001703|E1|Reported Event|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
265490|NCT00001723|B3|Baseline|Total|Total of all reporting groups
265491|NCT00001723|B2|Baseline|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program
Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265492|NCT00001723|B1|Baseline|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program
Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265493|NCT00001723|P2|Participant Flow|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program
Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265494|NCT00001723|P1|Participant Flow|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program
Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265495|NCT00001723|O4|Outcome|Placebo - Non-Hispanic Whites|Change in weight for Non-Hispanic White participants treated with placebo
265496|NCT00001723|O3|Outcome|Placebo - Non-Hispanic Blacks|Change in weight for Non-Hispanic Black participants treated with placebo
265497|NCT00001723|O2|Outcome|Orlistat - Non- Hispanic Whites|Change in weight for Non-Hispanic White participants treated with orlistat
265498|NCT00001723|O1|Outcome|Orlistat - Non-Hispanic Blacks|Change in weight for Non-Hispanic Black participants treated with orlistat
265499|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program
Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265500|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program
Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265501|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program
Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265502|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program
Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265503|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program
Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265504|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program
Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265505|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program
Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265506|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program
Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
265507|NCT00001723|E2|Reported Event|Placebo|Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
265508|NCT00001723|E1|Reported Event|Orlistat|Orlistat 120 mg TID for 6 months plus a behavioral weight loss program Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
265509|NCT00002766|B3|Baseline|Total|Total of all reporting groups
265510|NCT00002766|B2|Baseline|L-20|"Standard Vincristine/Prednisone (L-20)"
265511|NCT00002766|B1|Baseline|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
265512|NCT00002766|P2|Participant Flow|L-20|"Standard Vincristine/Prednisone (L-20) Patients receive induction therapy consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times daily on days 1-29, cyclophosphamide IV on day 5, doxorubicin IV on days 23-25 and 42, methotrexate intrathecally on days 3, 5, 13, 16, 32, and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover."
265513|NCT00002766|P1|Participant Flow|All-2|"ARA-C/High-Dose Mitoxantrone(All-2) Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5 with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4. Patients receive sargramostim (GM-CSF) subcutaneously or IV over 4 hours beginning on day 7 and continuing until blood counts recover."
265518|NCT00002842|B1|Baseline|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks
floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.
fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.
leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.
adjuvant therapy: Chemotherapy given after hepatic resection
conventional surgery: Hepatic resection"
265519|NCT00002842|P1|Participant Flow|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks
floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.
fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.
leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.
adjuvant therapy: Chemotherapy given after hepatic resection
conventional surgery: Hepatic resection"
265520|NCT00002842|O1|Outcome|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks
floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.
fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.
leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.
adjuvant therapy: Chemotherapy given after hepatic resection
conventional surgery: Hepatic resection"
265521|NCT00002842|E1|Reported Event|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks
floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.
fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.
leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.
adjuvant therapy: Chemotherapy given after hepatic resection
conventional surgery: Hepatic resection"
265522|NCT00002850|B4|Baseline|Total|Total of all reporting groups
265523|NCT00002850|B3|Baseline|Observation|No prophylaxis: The patient will receive no prophylactic antibiotics.
265524|NCT00002850|B2|Baseline|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
265525|NCT00002850|B1|Baseline|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
265526|NCT00002850|P3|Participant Flow|Observation|Patients observed without intervention and evaluated for SBI for the first 2 months of treatment.
265527|NCT00002850|P2|Participant Flow|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
265528|NCT00002850|P1|Participant Flow|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
265529|NCT00002850|O3|Outcome|No Prophylaxis|The patient will receive no prophylactic antibiotics.
265530|NCT00002850|O2|Outcome|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
265531|NCT00002850|O1|Outcome|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
265532|NCT00002850|E3|Reported Event|Observation|No Prophylaxis: The patient will receive no prophylactic antibiotics.
265533|NCT00002850|E2|Reported Event|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
265534|NCT00002850|E1|Reported Event|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
265535|NCT00002874|B3|Baseline|Total|Total of all reporting groups
265548|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
265549|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
265550|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
265551|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
265552|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
265553|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
265554|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
265555|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
265556|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
265557|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
265558|NCT00002874|E2|Reported Event|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
265559|NCT00002874|E1|Reported Event|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
265560|NCT00002931|B1|Baseline|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
265561|NCT00002931|P1|Participant Flow|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
265562|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
265563|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
265564|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
265565|NCT00002931|E1|Reported Event|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
265566|NCT00002975|B1|Baseline|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
265567|NCT00002975|P1|Participant Flow|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
265568|NCT00002975|O1|Outcome|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
265569|NCT00002975|E1|Reported Event|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
265570|NCT00003457|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265571|NCT00003457|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265572|NCT00003457|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265573|NCT00003457|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265574|NCT00003457|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265575|NCT00003458|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265576|NCT00003458|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265577|NCT00003458|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265578|NCT00003458|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265579|NCT00003458|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265580|NCT00003459|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
265581|NCT00003459|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
265582|NCT00003459|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
265583|NCT00003459|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
265584|NCT00003459|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
265585|NCT00003460|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265586|NCT00003460|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265587|NCT00003460|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265588|NCT00003460|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265589|NCT00003460|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265590|NCT00003468|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265591|NCT00003468|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Children with a low-grade astrocytoma who have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265592|NCT00003468|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265593|NCT00003468|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265594|NCT00003468|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265595|NCT00003469|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265596|NCT00003469|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265597|NCT00003469|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265598|NCT00003469|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265599|NCT00003469|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265600|NCT00003470|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
265601|NCT00003470|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265748|NCT00003224|O4|Outcome|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
312800|NCT00236899|B5|Baseline|Total|Total of all reporting groups
265602|NCT00003470|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
265603|NCT00003470|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
265604|NCT00003470|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265605|NCT00003473|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265606|NCT00003473|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal, to mitigate adverse reactions to treatment, until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265607|NCT00003473|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265608|NCT00003473|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265609|NCT00003473|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265610|NCT00003475|B1|Baseline|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265611|NCT00003475|P1|Participant Flow|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265612|NCT00003475|O1|Outcome|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
265613|NCT00003475|O1|Outcome|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
265614|NCT00003475|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
265615|NCT00003476|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265616|NCT00003476|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265785|NCT00003377|E2|Reported Event|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
265617|NCT00003476|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265618|NCT00003476|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265619|NCT00003476|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
265620|NCT00003477|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal)."
265621|NCT00003477|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal)."
265622|NCT00003477|O1|Outcome|Antineoplaston Therapy|Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
265623|NCT00003477|O1|Outcome|Antineoplaston Therapy|Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
265624|NCT00003477|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with a visual pathway glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
265625|NCT00003479|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265626|NCT00003479|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265627|NCT00003479|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265628|NCT00003479|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265629|NCT00003479|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265630|NCT00003483|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265631|NCT00003483|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265632|NCT00003483|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265633|NCT00003483|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265634|NCT00003483|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265749|NCT00003224|O3|Outcome|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
265635|NCT00003537|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265636|NCT00003537|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265637|NCT00003537|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265638|NCT00003537|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265639|NCT00003537|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
265640|NCT00003590|B1|Baseline|Hydroxyurea|"Only eligible patients were included in the analyses.
Patients received 20 mg/kg/day taken orally."
265641|NCT00003590|P1|Participant Flow|Hydroxyurea|"Only eligible patients were included in the analyses.
Patients received 20 mg/kg/day taken orally."
265642|NCT00003590|O1|Outcome|Hydroxyurea|Patients received 20 mg/kg/day PO.
265643|NCT00003590|O1|Outcome|Hydroxyurea|Patients received 20 mg/kg/day PO.
265644|NCT00003590|E1|Reported Event|Hydroxyurea|Patients received Hydroxyurea (20 mg/kg/day orally) up to 2 years in absence of progressive disease.
265645|NCT00003631|B4|Baseline|Total|Total of all reporting groups
265646|NCT00003631|B3|Baseline|Group C - Unfavorable Prognostic Group|
265647|NCT00003631|B2|Baseline|Group B - Intermediate Prognostic Group|
265648|NCT00003631|B1|Baseline|Group A - Favorable Prognostic Group|
265649|NCT00003631|P3|Participant Flow|Group C - Unfavorable Prognostic Group|
265650|NCT00003631|P2|Participant Flow|Group B - Intermediate Prognostic Group|
265651|NCT00003631|P1|Participant Flow|Group A - Favorable Prognostic Group|
265652|NCT00003631|O3|Outcome|Group C - Unfavorable Prognostic Group|
265653|NCT00003631|O2|Outcome|Group B - Intermediate Prognostic Group|
265654|NCT00003631|O1|Outcome|Group A - Favorable Prognostic Group|
265655|NCT00003631|E3|Reported Event|Group C - Unfavorable Prognostic Group|
265656|NCT00003631|E2|Reported Event|Group B - Intermediate Prognostic Group|
265657|NCT00003631|E1|Reported Event|Group A - Favorable Prognostic Group|
265658|NCT00003726|B1|Baseline|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
265659|NCT00003726|P1|Participant Flow|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
265660|NCT00003726|O1|Outcome|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
265661|NCT00003726|E1|Reported Event|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
265662|NCT00003782|B4|Baseline|Total|Total of all reporting groups
265663|NCT00003782|B3|Baseline|Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
265664|NCT00003782|B2|Baseline|Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
265665|NCT00003782|B1|Baseline|Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
265666|NCT00003782|P3|Participant Flow|Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
265667|NCT00003782|P2|Participant Flow|Arm 2: Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
265668|NCT00003782|P1|Participant Flow|Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
265669|NCT00003782|O3|Outcome|Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
265670|NCT00003782|O2|Outcome|Arm 2: Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
265671|NCT00003782|O1|Outcome|Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
265672|NCT00003782|E3|Reported Event|Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
265673|NCT00003782|E2|Reported Event|Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
265674|NCT00003782|E1|Reported Event|Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
265675|NCT00003820|B1|Baseline|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 per week by IV infusion for 4 consecutive weeks
314955|NCT00240331|O2|Outcome|Placebo|Matching placebo
265676|NCT00003820|P2|Participant Flow|Rituximab 375 mg/m2 Per Week Secondary Group|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months
Secondary Group of participants were added after the addition of the three extra cycle treatments."
265677|NCT00003820|P1|Participant Flow|Rituximab 375 mg/m2 Per Week Inital Group|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months
Initial Group of participants prior to the addition of the three extra cycle treatments."
265678|NCT00003820|O1|Outcome|Rituximab 375 mg/m2 Per Week|375 mg/m2 rituximab by IV infusion weekly, assessed after 4 weeks of treatment
265679|NCT00003820|O1|Outcome|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks
265680|NCT00003820|O1|Outcome|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks every 6 months, for up to 4 treatment cycles
265681|NCT00003820|E1|Reported Event|Rituximab 375 mg/m2 Per Week|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months for 2 years.
This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group."
265682|NCT00003869|B3|Baseline|Total|Total of all reporting groups
265683|NCT00003869|B2|Baseline|Placebo|250 mg placebo administered daily
265684|NCT00003869|B1|Baseline|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
265685|NCT00003869|P2|Participant Flow|Placebo|250 mg placebo administered daily
265686|NCT00003869|P1|Participant Flow|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
265687|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
265688|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
265689|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
265690|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
265691|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
265692|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
265693|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
265694|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
265695|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
265696|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
265697|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
265698|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
265699|NCT00003869|E2|Reported Event|Placebo|250 mg placebo administered daily
265700|NCT00003869|E1|Reported Event|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
265701|NCT00003875|B1|Baseline|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.
STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.
POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.
busulfan: Given PO or IV
etoposide: Given IV
aldesleukin: Given SC
peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
265702|NCT00003875|P1|Participant Flow|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.
STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.
POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.
busulfan: Given PO or IV
etoposide: Given IV
aldesleukin: Given SC
peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
265703|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.
STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.
POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.
busulfan: Given PO or IV
etoposide: Given IV
aldesleukin: Given SC
peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
265704|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.
STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.
POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.
busulfan: Given PO or IV
etoposide: Given IV
aldesleukin: Given SC
peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
265705|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.
STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.
POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.
busulfan: Given PO or IV
etoposide: Given IV
aldesleukin: Given SC
peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
265706|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.
STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.
POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.
busulfan: Given PO or IV
etoposide: Given IV
aldesleukin: Given SC
peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
265707|NCT00003875|E1|Reported Event|Treatment|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.
STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.
POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.
busulfan: Given PO or IV
etoposide: Given IV
aldesleukin: Given SC
peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
265708|NCT00003199|B1|Baseline|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.
tamoxifen citrate: Given orally
busulfan: Given orally
thiotepa: Given IV
melphalan: Given IV
aldesleukin: Given SC
sargramostim: Given SC
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion
radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
265709|NCT00003199|P1|Participant Flow|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.
tamoxifen citrate: Given orally
busulfan: Given orally
thiotepa: Given IV
melphalan: Given IV
aldesleukin: Given SC
sargramostim: Given SC
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion
radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
265710|NCT00003199|O1|Outcome|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.
tamoxifen citrate: Given orally
busulfan: Given orally
thiotepa: Given IV
melphalan: Given IV
aldesleukin: Given SC
sargramostim: Given SC
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion
radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
265711|NCT00003199|O1|Outcome|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.
tamoxifen citrate: Given orally
busulfan: Given orally
thiotepa: Given IV
melphalan: Given IV
aldesleukin: Given SC
sargramostim: Given SC
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion
radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
265712|NCT00003199|O1|Outcome|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.
tamoxifen citrate: Given orally
busulfan: Given orally
thiotepa: Given IV
melphalan: Given IV
aldesleukin: Given SC
sargramostim: Given SC
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion
radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
265713|NCT00003199|E1|Reported Event|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.
tamoxifen citrate: Given orally
busulfan: Given orally
thiotepa: Given IV
melphalan: Given IV
aldesleukin: Given SC
sargramostim: Given SC
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion
radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
265714|NCT00003222|B3|Baseline|Total|Total of all reporting groups
265715|NCT00003222|B2|Baseline|Peptides in GMCSF-in-adjuvant|
265716|NCT00003222|B1|Baseline|Peptides Pulsed on Dendritic Cells|
265717|NCT00003222|P2|Participant Flow|Peptides in Sargramostim (GMCSF)-In-Montanide ISA-51 Adjuvant|---Peptides were administered in an emulsion of sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's) adjuvant
265718|NCT00003222|P1|Participant Flow|Peptides Pulsed on Dendritic Cells|---peptides were pulsed on monocyte-derived dendritic cells cultures in GM-CSF and IL-4
265719|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
265720|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
265721|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
265722|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
265723|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
265724|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
265725|NCT00003222|E2|Reported Event|Peptides in GMCSF-in-adjuvant|
265726|NCT00003222|E1|Reported Event|Peptides Pulsed on Dendritic Cells|
265727|NCT00003224|B7|Baseline|Total|Total of all reporting groups
265728|NCT00003224|B6|Baseline|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
265729|NCT00003224|B5|Baseline|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
265730|NCT00003224|B4|Baseline|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
265731|NCT00003224|B3|Baseline|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
265732|NCT00003224|B2|Baseline|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
265733|NCT00003224|B1|Baseline|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
265734|NCT00003224|P6|Participant Flow|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
265735|NCT00003224|P5|Participant Flow|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
265736|NCT00003224|P4|Participant Flow|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
265737|NCT00003224|P3|Participant Flow|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
265738|NCT00003224|P2|Participant Flow|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
265739|NCT00003224|P1|Participant Flow|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
265740|NCT00003224|O6|Outcome|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
265741|NCT00003224|O5|Outcome|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
265742|NCT00003224|O4|Outcome|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
265743|NCT00003224|O3|Outcome|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
265744|NCT00003224|O2|Outcome|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
265745|NCT00003224|O1|Outcome|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
265746|NCT00003224|O6|Outcome|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
265747|NCT00003224|O5|Outcome|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
315910|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
265750|NCT00003224|O2|Outcome|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
265751|NCT00003224|O1|Outcome|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
265752|NCT00003224|O2|Outcome|All Montanide ISA-51|The toxicities are grouped for those receiving the vaccine adjuvant IFA (Montanide ISA-51).
265753|NCT00003224|O1|Outcome|All QS-21|The toxicities are grouped for those receiving the vaccine adjuvant QS-21.
265754|NCT00003224|E2|Reported Event|Montanide ISA-51 Adjuvant|The combination of participants from Arms 2, 4, and 6, all treated with peptides plus Montanide ISA-51 adjuvant
265755|NCT00003224|E1|Reported Event|QS-21 Adjuvant|The combination of participants from Arms 1, 3, and 5, all treated with peptides plus QS-21 adjuvant
265756|NCT00003298|B1|Baseline|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
265757|NCT00003298|P1|Participant Flow|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
265758|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
265759|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
265760|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
265761|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
265762|NCT00003298|E2|Reported Event|Step 2 (Adjuvant Therapy)|After neoadjuvant therapy, patients undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
265763|NCT00003298|E1|Reported Event|Step 1(Neoadjuvant Therapy)|Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1.
265764|NCT00003377|B6|Baseline|Total|Total of all reporting groups
265765|NCT00003377|B5|Baseline|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
265766|NCT00003377|B4|Baseline|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
265767|NCT00003377|B3|Baseline|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
265768|NCT00003377|B2|Baseline|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
265769|NCT00003377|B1|Baseline|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
265770|NCT00003377|P5|Participant Flow|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
265771|NCT00003377|P4|Participant Flow|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
265772|NCT00003377|P3|Participant Flow|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
265773|NCT00003377|P2|Participant Flow|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
265774|NCT00003377|P1|Participant Flow|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
265775|NCT00003377|O1|Outcome|Arm 2, P I & II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
265776|NCT00003377|O1|Outcome|Arm 2, P I & II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
265777|NCT00003377|O5|Outcome|Arm 2, PII|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
265778|NCT00003377|O4|Outcome|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
265786|NCT00003377|E1|Reported Event|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
265787|NCT00003389|B3|Baseline|Total|Total of all reporting groups
265788|NCT00003389|B2|Baseline|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
265789|NCT00003389|B1|Baseline|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
265790|NCT00003389|P2|Participant Flow|Arm B (Stanford V)|"Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
Doxorubicin: given IV
Bleomycin: given IV
Vinblastine: given IV
Vincristine: given IV
Mechlorethamine: given IV
Etoposide: given IV
Prednisone: taken orally
Cyclophosphamide: given IV
Radiotherapy"
265791|NCT00003389|P1|Participant Flow|Arm A (ABVD)|"Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
Doxorubicin: given IV
Bleomycin: given IV
Vinblastine: given IV
Dacarbazine: given IV
Radiotherapy"
265792|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
265793|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
265794|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
265795|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
265796|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
265797|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
265961|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|experimental arm
265798|NCT00003389|E2|Reported Event|Arm B (Stanford V)|Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
265799|NCT00003389|E1|Reported Event|Arm A (ABVD)|Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
265800|NCT00003895|B3|Baseline|Total|Total of all reporting groups
265801|NCT00003895|B2|Baseline|Arm B (Every 3 Weeks)|
265802|NCT00003895|B1|Baseline|Arm A (Every 2 Weeks)|
265803|NCT00003895|P2|Participant Flow|gp100:209-217(210M) and HPV 16 E7:12-20 (Every 3 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies"
265804|NCT00003895|P1|Participant Flow|gp100:209-217(210M)and HPV 16 E7:12-20 (Every 2 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies"
265805|NCT00003895|O2|Outcome|Arm B (Every 3 Weeks, gp100:209-217(210M) + HPV 16 E7:12-20)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies"
265806|NCT00003895|O1|Outcome|Arm A (Every 2 Weeks, gp100:209-217(210M) and HPV 16 E7:12-20)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies"
265807|NCT00003895|E2|Reported Event|Arm B (Every 3 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies"
265808|NCT00003895|E1|Reported Event|Arm A (Every 2 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
HPV 16 E7:12-20 peptide vaccine: Given SC
gp100:209-217(210M) peptide vaccine: Given SC
laboratory biomarker analysis: Correlative studies"
265809|NCT00003896|B1|Baseline|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
265810|NCT00003896|P1|Participant Flow|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
265811|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Liposomal Doxorubicin|
265812|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
265813|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
265814|NCT00003896|E1|Reported Event|Paclitaxel/CDDP/Liposomal Doxorubicin|
265815|NCT00003901|B1|Baseline|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
265816|NCT00003901|P1|Participant Flow|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
265817|NCT00003901|O2|Outcome|OM Positive in Bone Marrow|Participants who had OM in bone marrow.
265818|NCT00003901|O1|Outcome|OM Negative in Bone Marrow|Participants who did not have OM in bone marrow.
265819|NCT00003901|O2|Outcome|OM Positive in Lymph Nodes|Participants who had OM in lymph nodes.
265820|NCT00003901|O1|Outcome|OM Negative in Lymph Nodes|Participants who did not have OM in lymph nodes.
265821|NCT00003901|O2|Outcome|OM Positive in Bone Marrow|Participants who had OM in bone marrow.
265822|NCT00003901|O1|Outcome|OM Negative in Bone Marrow|Participants who did not have OM in bone marrow.
265823|NCT00003901|O2|Outcome|OM Positive in Lymph Nodes|Participants who had OM in lymph nodes.
265824|NCT00003901|O1|Outcome|OM Negative in Lymph Nodes|Participants who did not have OM in lymph nodes.
265825|NCT00003901|E1|Reported Event|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
265826|NCT00003907|B3|Baseline|Total|Total of all reporting groups
265827|NCT00003907|B2|Baseline|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
266061|NCT00004547|B4|Baseline|Total|Total of all reporting groups
265828|NCT00003907|B1|Baseline|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
265829|NCT00003907|P2|Participant Flow|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
265830|NCT00003907|P1|Participant Flow|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
265831|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
265832|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
265833|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
265834|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
265835|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
265836|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
265837|NCT00003907|E2|Reported Event|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
265838|NCT00003907|E1|Reported Event|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
265839|NCT00003910|B1|Baseline|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
265840|NCT00003910|P2|Participant Flow|Cyclophosphomide|Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
265841|NCT00003910|P1|Participant Flow|Methotrexate|"MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. If patient had a partial response, MTX was continued for up to 1 year. If patient had CR, MTX was continued for 1 month.
If no response, then pt went onto step 2 and received CY."
265842|NCT00003910|O1|Outcome|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
265843|NCT00003910|E2|Reported Event|Cyclophosphamide|step 2 patients who received CY
265844|NCT00003910|E1|Reported Event|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
265845|NCT00004092|B3|Baseline|Total|Total of all reporting groups
265846|NCT00004092|B2|Baseline|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.
filgrastim: Given IV or subcutaneously
carboplatin: Given IV
cyclophosphamide: Given IV
thiotepa: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
265847|NCT00004092|B1|Baseline|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.
filgrastim: Given IV or subcutaneously
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
265848|NCT00004092|P2|Participant Flow|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.
filgrastim: Given IV or subcutaneously
carboplatin: Given IV
cyclophosphamide: Given IV
thiotepa: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
265849|NCT00004092|P1|Participant Flow|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.
filgrastim: Given IV or subcutaneously
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
265918|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
265850|NCT00004092|O2|Outcome|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.
filgrastim: Given IV or subcutaneously
carboplatin: Given IV
cyclophosphamide: Given IV
thiotepa: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
265851|NCT00004092|O1|Outcome|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.
filgrastim: Given IV or subcutaneously
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
265852|NCT00004092|O2|Outcome|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.
filgrastim: Given IV or subcutaneously
carboplatin: Given IV
cyclophosphamide: Given IV
thiotepa: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
265853|NCT00004092|O1|Outcome|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.
filgrastim: Given IV or subcutaneously
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
265854|NCT00004092|E2|Reported Event|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.
filgrastim: Given IV or subcutaneously
carboplatin: Given IV
cyclophosphamide: Given IV
thiotepa: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
265855|NCT00004092|E1|Reported Event|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.
filgrastim: Given IV or subcutaneously
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
265856|NCT00004143|B1|Baseline|All Patients|
265857|NCT00004143|P1|Participant Flow|All Patients|
265858|NCT00004143|O1|Outcome|All Patients|
265859|NCT00004143|O1|Outcome|All Patients|
265860|NCT00004143|O1|Outcome|All Patients|
265861|NCT00004143|O1|Outcome|All Patients|
265862|NCT00004143|O1|Outcome|All Patients|
265863|NCT00004143|O1|Outcome|All Patients|
265864|NCT00004143|E1|Reported Event|All Patients|
265865|NCT00004146|B1|Baseline|CAI With RT - Arm 1|"CAI with RT
carboxyamidotriazole :
CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival
radiation therapy :"
265866|NCT00004146|P1|Participant Flow|CAI With RT - Arm 1|"CAI with RT
carboxyamidotriazole :
CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival
radiation therapy :"
265867|NCT00004146|O2|Outcome|CAI With RT Without Enzyme Inducing Anticonvulsants|"CAI with RT
carboxyamidotriazole :
CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival
radiation therapy :"
265868|NCT00004146|O1|Outcome|CAI With RT + Enzyme Inducing Anticonvulsants|"CAI with RT
carboxyamidotriazole :
CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival
radiation therapy :"
265869|NCT00004146|O1|Outcome|CAI With RT - Arm 1|"CAI with RT
carboxyamidotriazole :
CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival
radiation therapy :"
265870|NCT00004146|O1|Outcome|CAI With RT - Arm 1|"CAI with RT
carboxyamidotriazole :
CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival
radiation therapy :"
265871|NCT00004146|E1|Reported Event|Arm 1|"CAI with RT
carboxyamidotriazole :
CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival
radiation therapy :"
265872|NCT00004228|B8|Baseline|Total|Total of all reporting groups
265873|NCT00004228|B7|Baseline|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265874|NCT00004228|B6|Baseline|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265875|NCT00004228|B5|Baseline|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265876|NCT00004228|B4|Baseline|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265877|NCT00004228|B3|Baseline|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265878|NCT00004228|B2|Baseline|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
265879|NCT00004228|B1|Baseline|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
265880|NCT00004228|P7|Participant Flow|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265881|NCT00004228|P6|Participant Flow|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265882|NCT00004228|P5|Participant Flow|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265883|NCT00004228|P4|Participant Flow|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265919|NCT00003138|E5|Reported Event|Erythropoietin (300 Units/kg) and Filgrastim (Step 4)|All patients received erythropoietin (150 units/kg) and filgrastim may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, increased their dose of erythropoietin to 300 units/kg.
265920|NCT00003138|E4|Reported Event|Erythropoietin (150 Units/kg) and Filgrastim (Step 3)|All patients received erythropoietin alone treatment may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, add filgrastim.
265884|NCT00004228|P3|Participant Flow|A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265885|NCT00004228|P2|Participant Flow|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
265886|NCT00004228|P1|Participant Flow|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
265887|NCT00004228|O7|Outcome|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265888|NCT00004228|O6|Outcome|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265889|NCT00004228|O5|Outcome|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265890|NCT00004228|O4|Outcome|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265891|NCT00004228|O3|Outcome|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265892|NCT00004228|O2|Outcome|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
265893|NCT00004228|O1|Outcome|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
265894|NCT00004228|O7|Outcome|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265895|NCT00004228|O6|Outcome|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265896|NCT00004228|O5|Outcome|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265897|NCT00004228|O4|Outcome|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265898|NCT00004228|O3|Outcome|A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265899|NCT00004228|O2|Outcome|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
265900|NCT00004228|O1|Outcome|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
265901|NCT00004228|E7|Reported Event|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265902|NCT00004228|E6|Reported Event|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265921|NCT00003138|E3|Reported Event|Erythropoietin (Cross-over; Step 2)|Patients in the supportive care arm who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm. Erythropoietin was administered at 150 units/kg subcutaneously every day.
265960|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
265903|NCT00004228|E5|Reported Event|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265904|NCT00004228|E4|Reported Event|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
265905|NCT00004228|E3|Reported Event|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate).
265906|NCT00004228|E2|Reported Event|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
265907|NCT00004228|E1|Reported Event|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
265908|NCT00003138|B3|Baseline|Total|Total of all reporting groups
265909|NCT00003138|B2|Baseline|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
265910|NCT00003138|B1|Baseline|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
265911|NCT00003138|P2|Participant Flow|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
265912|NCT00003138|P1|Participant Flow|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
265913|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
265914|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
265915|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
265916|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
265917|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
265922|NCT00003138|E2|Reported Event|Erythropoietin (Step 1)|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
315911|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
265923|NCT00003138|E1|Reported Event|Supportive Care (Step 1)|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
265924|NCT00003641|B3|Baseline|Total|Total of all reporting groups
265925|NCT00003641|B2|Baseline|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.
interferon alfa-2b: Given IV"
265926|NCT00003641|B1|Baseline|Observation|Patients undergo observation for 4 weeks.
265927|NCT00003641|P2|Participant Flow|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.
interferon alfa-2b: Given IV"
265928|NCT00003641|P1|Participant Flow|Observation|Patients undergo observation for 4 weeks.
265929|NCT00003641|O2|Outcome|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.
interferon alfa-2b: Given IV"
265930|NCT00003641|O1|Outcome|Observation|Patients undergo observation for 4 weeks.
265931|NCT00003641|O2|Outcome|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.
interferon alfa-2b: Given IV"
265932|NCT00003641|O1|Outcome|Observation|Patients undergo observation for 4 weeks.
265933|NCT00003641|E2|Reported Event|Interferon Alfa-2b|Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days
265934|NCT00003641|E1|Reported Event|Observation|Patients undergo observation for 4 weeks
265935|NCT00003659|B1|Baseline|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
265936|NCT00003659|P1|Participant Flow|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
265937|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
265938|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
265939|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
265940|NCT00003659|E1|Reported Event|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
265941|NCT00004732|B3|Baseline|Total|Total of all reporting groups
265942|NCT00004732|B2|Baseline|Carotid Endarterectomy|Patients Randomized to CEA
265943|NCT00004732|B1|Baseline|Carotid-Artery Stenting|Patients Randomized to CAS
265944|NCT00004732|P2|Participant Flow|Carotid Endarterectomy (CEA)|CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
265945|NCT00004732|P1|Participant Flow|Carotid-Artery Stenting (CAS)|CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open.
265946|NCT00004732|O2|Outcome|Carotid Endarterectomy|Patients randomized to CEA
265947|NCT00004732|O1|Outcome|Carotid-Artery Stenting|Patients randomized to CAS
265948|NCT00004732|O2|Outcome|Carotid Endarterectomy|Patients Randomized to CEA
265949|NCT00004732|O1|Outcome|Carotid-Artery Stenting|Patients Randomized to CAS
265950|NCT00004732|E2|Reported Event|Carotid Endarterectomy|Patients Randomized to CEA
265951|NCT00004732|E1|Reported Event|Carotid-Artery Stenting|Patients Randomized to CAS
265952|NCT00004859|B3|Baseline|Total|Total of all reporting groups
265953|NCT00004859|B2|Baseline|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.
Paclitaxel, carboplatin and radiation same as active comparator."
265954|NCT00004859|B1|Baseline|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
265955|NCT00004859|P2|Participant Flow|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.
Paclitaxel, carboplatin and radiation same as active comparator."
265956|NCT00004859|P1|Participant Flow|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
265957|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|experimental arm
265958|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|active comparator
265959|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.
Paclitaxel, carboplatin and radiation same as active comparator."
265962|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|active comparator
265963|NCT00004859|E2|Reported Event|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.
Paclitaxel, carboplatin and radiation same as active comparator."
265964|NCT00004859|E1|Reported Event|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
265965|NCT00004888|B3|Baseline|Total|Total of all reporting groups
265966|NCT00004888|B2|Baseline|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
265967|NCT00004888|B1|Baseline|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
265968|NCT00004888|P2|Participant Flow|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
265969|NCT00004888|P1|Participant Flow|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
265970|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
265971|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
265972|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
265973|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
265974|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
265975|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
265976|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
265977|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
265978|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
265979|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
265980|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
265981|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
315912|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
265982|NCT00004888|E2|Reported Event|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
265983|NCT00004888|E1|Reported Event|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
265984|NCT00004978|B3|Baseline|Total|Total of all reporting groups
265985|NCT00004978|B2|Baseline|No rIL-2|Control group - no study-assigned medication
265986|NCT00004978|B1|Baseline|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
265987|NCT00004978|P2|Participant Flow|No rIL-2|Control group - no study-assigned medication
265988|NCT00004978|P1|Participant Flow|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
265989|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
265990|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
265991|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
265992|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
265993|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
265994|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
265995|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
265996|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
265997|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
265998|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
265999|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
266000|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
266001|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
266002|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
266003|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
266004|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
266005|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
266006|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
266007|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
266008|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
266009|NCT00004978|E2|Reported Event|No rIL-2|Control group - no study-assigned medication
266010|NCT00004978|E1|Reported Event|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
266011|NCT00004980|B3|Baseline|Total|Total of all reporting groups
266012|NCT00004980|B2|Baseline|Placebo|Participants received sham stimulation
266013|NCT00004980|B1|Baseline|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
266014|NCT00004980|P2|Participant Flow|Placebo|Participants received sham stimulation
266015|NCT00004980|P1|Participant Flow|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
266016|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
266017|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
266018|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
266019|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
266020|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
266021|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
266022|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
266023|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
266024|NCT00004980|E2|Reported Event|Placebo|Participants received sham stimulation
266025|NCT00004980|E1|Reported Event|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
266026|NCT00004054|B3|Baseline|Total|Total of all reporting groups
266027|NCT00004054|B2|Baseline|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
266028|NCT00004054|B1|Baseline|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
266029|NCT00004054|P2|Participant Flow|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
266142|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
266143|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
266030|NCT00004054|P1|Participant Flow|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
266031|NCT00004054|O2|Outcome|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
266032|NCT00004054|O1|Outcome|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
266033|NCT00004054|E2|Reported Event|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin) and chemotherapy. Androgen suppression will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
266034|NCT00004054|E1|Reported Event|Hormones and RT|AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin). Androgen suppression will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of RT.
266035|NCT00004412|B4|Baseline|Total|Total of all reporting groups
266036|NCT00004412|B3|Baseline|Crossover|Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Standard local care dressing only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed & traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm ( standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.
266037|NCT00004412|B2|Baseline|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
266038|NCT00004412|B1|Baseline|Standard Local Care Dressing|Standard local care dressing including cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
266039|NCT00004412|P3|Participant Flow|Crossover|Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Allevyn Hydrophilic PU dressing (standard local care) only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed & traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm ( standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.
266040|NCT00004412|P2|Participant Flow|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
266041|NCT00004412|P1|Participant Flow|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
266042|NCT00004412|O2|Outcome|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
266043|NCT00004412|O1|Outcome|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
266044|NCT00004412|O2|Outcome|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
266045|NCT00004412|O1|Outcome|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
266046|NCT00004412|E2|Reported Event|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
266047|NCT00004412|E1|Reported Event|Standard Local Care Dressing|Standard local care including cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
266048|NCT00004500|B3|Baseline|Total|Total of all reporting groups
266049|NCT00004500|B2|Baseline|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
266050|NCT00004500|B1|Baseline|Lucinactant|Lucinactant via bronchoaveolar lavage
266051|NCT00004500|P2|Participant Flow|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
266052|NCT00004500|P1|Participant Flow|Lucinactant|Lucinactant via bronchoaveolar lavage
266053|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
266054|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
266055|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
266056|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
266057|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
266058|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
266059|NCT00004500|E2|Reported Event|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
266060|NCT00004500|E1|Reported Event|Lucinactant|Lucinactant via bronchoaveolar lavage
266062|NCT00004547|B3|Baseline|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
266063|NCT00004547|B2|Baseline|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
266064|NCT00004547|B1|Baseline|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
266065|NCT00004547|P3|Participant Flow|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
266066|NCT00004547|P2|Participant Flow|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
266067|NCT00004547|P1|Participant Flow|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
266068|NCT00004547|O2|Outcome|Tumor Tissue|Diseased tissue
266069|NCT00004547|O1|Outcome|Normal Tissue|Non-diseased tissue
266070|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
266071|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
266072|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
266073|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
266074|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
266075|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
266076|NCT00004547|O1|Outcome|Mesothelioma, Low Grade, and Adenocarcinoma|Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
266077|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
266144|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
266145|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
266146|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
266078|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
266079|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
266080|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
266081|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
266082|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
266083|NCT00004547|E1|Reported Event|Mesothelioma, Low Grade, and Adenocarcinoma|Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
266084|NCT00004562|B3|Baseline|Total|Total of all reporting groups
266085|NCT00004562|B2|Baseline|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
266086|NCT00004562|B1|Baseline|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
266087|NCT00004562|P2|Participant Flow|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
266088|NCT00004562|P1|Participant Flow|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
266089|NCT00004562|O2|Outcome|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
266090|NCT00004562|O1|Outcome|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
266091|NCT00004562|O2|Outcome|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
266092|NCT00004562|O1|Outcome|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
266093|NCT00004562|E2|Reported Event|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
266094|NCT00004562|E1|Reported Event|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
266095|NCT00004563|B3|Baseline|Total|Total of all reporting groups
266096|NCT00004563|B2|Baseline|Placebo|"Matching gel caps at a dose of 25 mg
Placebo: Matching gelcaps 25 mgs"
266097|NCT00004563|B1|Baseline|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.
Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
266098|NCT00004563|P2|Participant Flow|Placebo|"Matching gel caps at a dose of 25 mg
Placebo: Matching gelcaps 25 mgs"
266099|NCT00004563|P1|Participant Flow|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.
Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
266100|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg
Placebo: Matching gelcaps 25 mgs"
266101|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.
Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
266102|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg
Placebo: Matching gelcaps 25 mgs"
266147|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
266148|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
266103|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.
Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
266104|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg
Placebo: Matching gelcaps 25 mgs"
266105|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.
Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
266106|NCT00004563|E2|Reported Event|Placebo|"Matching gel caps at a dose of 25 mg
Placebo: Matching gelcaps 25 mgs"
266107|NCT00004563|E1|Reported Event|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.
Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
266108|NCT00004635|B3|Baseline|Total|Total of all reporting groups
266109|NCT00004635|B2|Baseline|Placebo Followed by Thalidomide|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received placebo for thalidomide. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received thalidomide 200 mg once a day.
266110|NCT00004635|B1|Baseline|Thalidomide Followed by Placebo|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received thalidomide orally 200 mg a day. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received the placebo for thalidomide once a day.
266111|NCT00004635|P2|Participant Flow|Placebo Followed by Thalidomide|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received placebo for thalidomide. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received thalidomide 200 mg once a day.
266112|NCT00004635|P1|Participant Flow|Thalidomide Followed by Placebo|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received thalidomide orally 200 mg a day. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received the placebo for thalidomide once a day.
266113|NCT00004635|O2|Outcome|Placebo|Participants who received placebo in period 1 or 2.
266114|NCT00004635|O1|Outcome|Thalidomide|Participants who received thalidomide in period 1 or 2.
266115|NCT00004635|O2|Outcome|Placebo|Participants who received placebo in period 1 or 2
266116|NCT00004635|O1|Outcome|Thalidomide|Participants who received thalidomide in period 1 or 2.
266117|NCT00004635|E4|Reported Event|Leuprolide|
266118|NCT00004635|E3|Reported Event|Goserelin (Zoladex)|
266119|NCT00004635|E2|Reported Event|Placebo|
266120|NCT00004635|E1|Reported Event|Thalidomide|
266121|NCT00005879|B3|Baseline|Total|Total of all reporting groups
266122|NCT00005879|B2|Baseline|Arzoxifene|"LY353381, 20 mg daily
arzoxifene: one tablet daily"
266123|NCT00005879|B1|Baseline|Placebo|"Placebo
Placebo: matched tablet dialy"
266124|NCT00005879|P2|Participant Flow|Arzoxifene|"LY353381, 20 mg daily
arzoxifene: one tablet daily"
266125|NCT00005879|P1|Participant Flow|Placebo|"Placebo
Placebo: matched tablet dialy"
266126|NCT00005879|O2|Outcome|Arzoxifene|"LY353381, 20 mg daily
arzoxifene: one tablet daily"
266127|NCT00005879|O1|Outcome|Placebo|"Placebo
Placebo: matched tablet dialy"
266128|NCT00005879|O2|Outcome|Arzoxifene|"LY353381, 20 mg daily
arzoxifene: one tablet daily"
266129|NCT00005879|O1|Outcome|Placebo|"Placebo
Placebo: matched tablet dialy"
266130|NCT00005879|E2|Reported Event|Arzoxifene|"LY353381, 20 mg daily
arzoxifene: one tablet daily"
266131|NCT00005879|E1|Reported Event|Placebo|"Placebo
Placebo: matched tablet dialy"
266132|NCT00005901|B3|Baseline|Total|Total of all reporting groups
266133|NCT00005901|B2|Baseline|Active Comparator: 2|Subjects who received Pamidronate every 6 months for 3 years.
266134|NCT00005901|B1|Baseline|Active Comparator: 1|Subjects who received Pamidronate every 3 months for 3 years.
266135|NCT00005901|P2|Participant Flow|Active Comparator: 2|Receives treatment every 6 months.
266136|NCT00005901|P1|Participant Flow|Active Comparator: 1|Receives treatment every 3 months
266137|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
266138|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
266139|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
266140|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
266141|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
266149|NCT00005901|E2|Reported Event|Active Comparator: 2|Subjects who received Pamidronate every 6 months for 3 years.
266150|NCT00005901|E1|Reported Event|Active Comparator: 1|Subjects who received Pamidronate every 3 months for 3 years.
266151|NCT00005906|B1|Baseline|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
266152|NCT00005906|P1|Participant Flow|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
266153|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
266154|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
266155|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
266156|NCT00005906|E1|Reported Event|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
266157|NCT00005908|B1|Baseline|Docetaxel/Capecitabine - A & B|Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
266158|NCT00005908|P2|Participant Flow|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
266159|NCT00005908|P1|Participant Flow|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
266160|NCT00005908|O1|Outcome|Dose A & B-Cohort 1 & 2-Arm 1 & 2-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
266161|NCT00005908|O2|Outcome|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1, capecitabine 937.5 mg/m^2 orally twice daily day 2-15
266162|NCT00005908|O1|Outcome|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
266163|NCT00005908|O1|Outcome|Dose A & B-Cohort 1 & 2-Arm 1& 2-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
266164|NCT00005908|O2|Outcome|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
266165|NCT00005908|O1|Outcome|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
266166|NCT00005908|E1|Reported Event|Docetaxel/Capecitabine - A & B|Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m2 intravenous day 1 capecitabine 937.5 mg/m2 orally twice daily day 2-15
266167|NCT00005937|B1|Baseline|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Antithymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration, the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
266168|NCT00005937|P1|Participant Flow|MDS Subjects Treated With ATG & CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
266169|NCT00005937|O1|Outcome|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
266170|NCT00005937|E1|Reported Event|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
266171|NCT00005947|B3|Baseline|Total|Total of all reporting groups
266172|NCT00005947|B2|Baseline|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
266173|NCT00005947|B1|Baseline|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
266335|NCT00005047|P3|Participant Flow|Arm III: Observation|Patients with unaltered (-) p53
266174|NCT00005947|P2|Participant Flow|Placebo|"All subjects randomized to receive placebo.
Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
266175|NCT00005947|P1|Participant Flow|Sipuleucel-T|"All subjects randomized to receive sipuleucel-T.
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
266176|NCT00005947|O2|Outcome|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
266177|NCT00005947|O1|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
266178|NCT00005947|O2|Outcome|Placebo|All subjects randomized to receive placebo
266179|NCT00005947|O1|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T.
266180|NCT00005947|E2|Reported Event|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
266181|NCT00005947|E1|Reported Event|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
266182|NCT00005957|B3|Baseline|Total|Total of all reporting groups
266183|NCT00005957|B2|Baseline|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
266184|NCT00005957|B1|Baseline|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
266185|NCT00005957|P2|Participant Flow|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
266186|NCT00005957|P1|Participant Flow|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 centigray (cGy) in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
266187|NCT00005957|O2|Outcome|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
266188|NCT00005957|O1|Outcome|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
266189|NCT00005957|O2|Outcome|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
266190|NCT00005957|O1|Outcome|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
266191|NCT00005957|E2|Reported Event|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
Analysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment."
266192|NCT00005957|E1|Reported Event|Standard Breast Irradiation|"radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
Analysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment."
266193|NCT00006237|B3|Baseline|Total|Total of all reporting groups
266194|NCT00006237|B2|Baseline|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
266195|NCT00006237|B1|Baseline|Interferon|interferon alfa
266196|NCT00006237|P2|Participant Flow|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
266197|NCT00006237|P1|Participant Flow|Interferon|interferon alfa IV
266198|NCT00006237|O2|Outcome|Biochemotherapy|Biochemotherapy
266199|NCT00006237|O1|Outcome|Interferon|Interferon
266200|NCT00006237|O2|Outcome|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
266201|NCT00006237|O1|Outcome|Interferon|interferon alfa
266202|NCT00006237|O2|Outcome|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
266203|NCT00006237|O1|Outcome|Interferon|interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
266204|NCT00006237|E2|Reported Event|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
266205|NCT00006237|E1|Reported Event|Interferon|interferon alfa
266333|NCT00005047|B1|Baseline|Arm I: M-VAC x 3|p53 positive, randomized to 3 cycles of adjuvant combination methotrexate, vinblastine, doxorubicin and cisplatin (MVAC)
266206|NCT00006244|B1|Baseline|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
266207|NCT00006244|P1|Participant Flow|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
266208|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
266209|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
266210|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
266211|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
266212|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
266213|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
266214|NCT00006244|E1|Reported Event|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
melphalan: Given IV
recombinant interferon alfa: Given SC
aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
266215|NCT00006289|B3|Baseline|Total|Total of all reporting groups
266216|NCT00006289|B2|Baseline|Neurotropin First, Then Placebo|Receive Neurotropin 4 tabs b.i.d. for 5 weeks and then Placebo 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
266217|NCT00006289|B1|Baseline|Placebo First, Then Neurotropin|Receive Placebo 4 tabs b.i.d. for 5 weeks and then Neurotropin 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
266218|NCT00006289|P2|Participant Flow|Neurotropin First, Then Placebo|Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
266219|NCT00006289|P1|Participant Flow|Placebo First, Then Neurotropin|Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
266220|NCT00006289|O4|Outcome|MPQ After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. MPQ was determined at the end of the 5 week-treatment of placebo."
266221|NCT00006289|O3|Outcome|MPQ After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
266222|NCT00006289|O2|Outcome|MPQ After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. MPQ was determined at the end of the 5 week-treatment of Neurotropin."
266223|NCT00006289|O1|Outcome|MPQ After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
266224|NCT00006289|O4|Outcome|NRS After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. NRS was determined at the end of the 5 week-treatment of placebo."
266225|NCT00006289|O3|Outcome|NRS After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
266226|NCT00006289|O2|Outcome|NRS After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. NRS was determined at the end of the 5 week-treatment of Neurotropin."
266227|NCT00006289|O1|Outcome|NRS After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
266228|NCT00006289|O4|Outcome|VAS After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. VAS was determined at the end of the 5 week-treatment of placebo."
266229|NCT00006289|O3|Outcome|VAS After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
266230|NCT00006289|O2|Outcome|VAS After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. VAS was determined at the end of the 5 week-treatment of Neurotropin."
266231|NCT00006289|O1|Outcome|VAS After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
266232|NCT00006289|E2|Reported Event|Neurotropin First, Then Placebo|Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
266233|NCT00006289|E1|Reported Event|Placebo First, Then Neurotropin|Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
266234|NCT00006305|B5|Baseline|Total|Total of all reporting groups
266235|NCT00006305|B4|Baseline|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
266236|NCT00006305|B3|Baseline|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
266237|NCT00006305|B2|Baseline|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
266238|NCT00006305|B1|Baseline|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
266239|NCT00006305|P4|Participant Flow|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
266240|NCT00006305|P3|Participant Flow|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
266241|NCT00006305|P2|Participant Flow|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
266242|NCT00006305|P1|Participant Flow|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
266243|NCT00006305|O4|Outcome|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
266244|NCT00006305|O3|Outcome|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
266245|NCT00006305|O2|Outcome|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
266246|NCT00006305|O1|Outcome|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
266247|NCT00006305|O4|Outcome|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
266248|NCT00006305|O3|Outcome|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
266249|NCT00006305|O2|Outcome|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
266250|NCT00006305|O1|Outcome|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
266251|NCT00006305|E4|Reported Event|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
268098|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
266252|NCT00006305|E3|Reported Event|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
266253|NCT00006305|E2|Reported Event|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
266254|NCT00006305|E1|Reported Event|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
266255|NCT00006389|B1|Baseline|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
bryostatin 1: Given IV
cisplatin: Given IV
laboratory biomarker analysis: Correlative studies"
266256|NCT00006389|P1|Participant Flow|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
bryostatin 1: Given IV
cisplatin: Given IV
laboratory biomarker analysis: Correlative studies"
266257|NCT00006389|O1|Outcome|Treatment|"Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
bryostatin 1: Given IV
cisplatin: Given IV
laboratory biomarker analysis: Correlative studies"
266258|NCT00006389|O1|Outcome|Treatment|"Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
bryostatin 1: Given IV
cisplatin: Given IV
laboratory biomarker analysis: Correlative studies"
266259|NCT00006389|O1|Outcome|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
bryostatin 1: Given IV
cisplatin: Given IV
laboratory biomarker analysis: Correlative studies"
266260|NCT00006389|E1|Reported Event|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
bryostatin 1: Given IV
cisplatin: Given IV
laboratory biomarker analysis: Correlative studies"
266261|NCT00006392|B5|Baseline|Total|Total of all reporting groups
266262|NCT00006392|B4|Baseline|Placebo|Matching placebo for vitamin E + matching placebo for selenium
266263|NCT00006392|B3|Baseline|Combination|Vitamin E + selenium
266264|NCT00006392|B2|Baseline|Selenium|Selenium + matching placebo for vitamin E
266265|NCT00006392|B1|Baseline|Vitamin E|Vitamin E + matching placebo for selenium
266266|NCT00006392|P4|Participant Flow|Placebo|Matching placebo for vitamin E + matching placebo for selenium
266267|NCT00006392|P3|Participant Flow|Combination|Vitamin E + selenium
266268|NCT00006392|P2|Participant Flow|Selenium|Selenium + matching placebo for vitamin E
266269|NCT00006392|P1|Participant Flow|Vitamin E|Vitamin E + matching placebo for selenium
266270|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
266271|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
266272|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
266273|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
266274|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
266275|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
266276|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
266277|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
266278|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
266279|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
266280|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
266281|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
266282|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
266283|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
266284|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
266285|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
266286|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
266287|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
266288|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
266289|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
266290|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
266291|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
266292|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
266293|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
266294|NCT00006392|E4|Reported Event|Vitamin E Alone|Vitamin E + placebo for selenium
266295|NCT00006392|E3|Reported Event|Placebo|Placebo for selenium + placebo for vitamin E
266296|NCT00006392|E2|Reported Event|Combination|Selenium + vitamin E
266297|NCT00006392|E1|Reported Event|Selenium Alone|Selenium + placebo for vitamin E
266298|NCT00006409|B7|Baseline|Total|Total of all reporting groups
266299|NCT00006409|B6|Baseline|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
266300|NCT00006409|B5|Baseline|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
266301|NCT00006409|B4|Baseline|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
266302|NCT00006409|B3|Baseline|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
266303|NCT00006409|B2|Baseline|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
266304|NCT00006409|B1|Baseline|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
266305|NCT00006409|P6|Participant Flow|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
266306|NCT00006409|P5|Participant Flow|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
266307|NCT00006409|P4|Participant Flow|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
266308|NCT00006409|P3|Participant Flow|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
266309|NCT00006409|P2|Participant Flow|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
266310|NCT00006409|P1|Participant Flow|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
266311|NCT00006409|O6|Outcome|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
266312|NCT00006409|O5|Outcome|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
266313|NCT00006409|O4|Outcome|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
266314|NCT00006409|O3|Outcome|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
266315|NCT00006409|O2|Outcome|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
266316|NCT00006409|O1|Outcome|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
266317|NCT00006409|O6|Outcome|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
266318|NCT00006409|O5|Outcome|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
266319|NCT00006409|O4|Outcome|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
266320|NCT00006409|O3|Outcome|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
266321|NCT00006409|O2|Outcome|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
266322|NCT00006409|O1|Outcome|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
266323|NCT00006409|E6|Reported Event|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
266324|NCT00006409|E5|Reported Event|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
266325|NCT00006409|E4|Reported Event|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
266326|NCT00006409|E3|Reported Event|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
266327|NCT00006409|E2|Reported Event|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
266328|NCT00006409|E1|Reported Event|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
266329|NCT00005047|B5|Baseline|Total|Total of all reporting groups
266330|NCT00005047|B4|Baseline|Arm IV: Observation|p53 positive, refused random assignment, assigned to observation/no intervention
266331|NCT00005047|B3|Baseline|Arm III: Observation|p53 negative, assigned to observation/no intervention
266332|NCT00005047|B2|Baseline|Arm II: Observation|p53 positive, randomized to observation/no intervention
266334|NCT00005047|P4|Participant Flow|Arm IV: Observation|Patients with altered (+) p53, patients did not consent to randomization
266336|NCT00005047|P2|Participant Flow|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
266337|NCT00005047|P1|Participant Flow|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC
cisplatin
doxorubicin hydrochloride
methotrexate
vinblastine"
266338|NCT00005047|O2|Outcome|p53 Negative Patients|Arm III: Observation; Patients with unaltered (-) p53
266339|NCT00005047|O1|Outcome|p53 Positive Patients|"Arm I: Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC
Arm II: Patients with altered (+) p53, reconsented to randomization, randomized to observation
Arm IV: Patients with altered (+) p53, patients did not consent to randomization"
266340|NCT00005047|O2|Outcome|p53 Negative Patients|Arm III: Observation; Patients with unaltered (-) p53
266341|NCT00005047|O1|Outcome|p53 Positive Patients|"Arm I: Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC
Arm II: Patients with altered (+) p53, reconsented to randomization, randomized to observation
Arm IV: Patients with altered (+) p53, patients did not consent to randomization"
266342|NCT00005047|O2|Outcome|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
266343|NCT00005047|O1|Outcome|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC
cisplatin
doxorubicin hydrochloride
methotrexate
vinblastine"
266344|NCT00005047|O2|Outcome|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
266345|NCT00005047|O1|Outcome|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC
cisplatin
doxorubicin hydrochloride
methotrexate
vinblastine"
266346|NCT00005047|E4|Reported Event|Arm IV: Observation|Patients with altered (+) p53, patients did not consent to randomization
266347|NCT00005047|E3|Reported Event|Arm III: Observation|Patients with unaltered (-) p53
266348|NCT00005047|E2|Reported Event|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
266349|NCT00005047|E1|Reported Event|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC
cisplatin
doxorubicin hydrochloride
methotrexate
vinblastine"
266350|NCT00005669|B3|Baseline|Total|Total of all reporting groups
266351|NCT00005669|B2|Baseline|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266352|NCT00005669|B1|Baseline|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266353|NCT00005669|P2|Participant Flow|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266354|NCT00005669|P1|Participant Flow|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266355|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266356|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266357|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266358|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266359|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266360|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266361|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266362|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266363|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266364|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266365|NCT00005669|E2|Reported Event|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266366|NCT00005669|E1|Reported Event|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
266367|NCT00006478|B1|Baseline|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
266715|NCT00006164|E1|Reported Event|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266368|NCT00006478|P1|Participant Flow|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
266369|NCT00006478|O1|Outcome|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
266370|NCT00006478|E1|Reported Event|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
266371|NCT00006489|B5|Baseline|Total|Total of all reporting groups
266372|NCT00006489|B4|Baseline|Placebo + Supportive Counseling|"Placebo alone
Placebo: Pill Placebo daily dosing 24 weeks"
266373|NCT00006489|B3|Baseline|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
266374|NCT00006489|B2|Baseline|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
Naltrexone: Daily dosing 100 mg for 24 weeks"
266375|NCT00006489|B1|Baseline|Naltrexone + Supportive Counseling|"Naltrexone alone
Naltrexone: Daily dosing 100 mg for 24 weeks"
266376|NCT00006489|P4|Participant Flow|Placebo + Supportive Counseling|"Placebo alone
Placebo: Pill Placebo daily dosing 24 weeks"
266377|NCT00006489|P3|Participant Flow|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
266378|NCT00006489|P2|Participant Flow|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
Naltrexone: Daily dosing 100 mg for 24 weeks"
266379|NCT00006489|P1|Participant Flow|Naltrexone + Supportive Counseling|"Naltrexone alone
Naltrexone: Daily dosing 100 mg for 24 weeks"
266380|NCT00006489|O4|Outcome|Placebo + Supportive Counseling|"Placebo alone
Placebo: Pill Placebo daily dosing 24 weeks"
266381|NCT00006489|O3|Outcome|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
266382|NCT00006489|O2|Outcome|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
Naltrexone: Daily dosing 100 mg for 24 weeks"
266383|NCT00006489|O1|Outcome|Naltrexone + Supportive Counseling|"Naltrexone alone
Naltrexone: Daily dosing 100 mg for 24 weeks"
266384|NCT00006489|O4|Outcome|Placebo + Supportive Counseling|"Placebo alone
Placebo: Pill Placebo daily dosing 24 weeks"
266385|NCT00006489|O3|Outcome|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
266386|NCT00006489|O2|Outcome|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
Naltrexone: Daily dosing 100 mg for 24 weeks"
266387|NCT00006489|O1|Outcome|Naltrexone + Supportive Counseling|"Naltrexone alone
Naltrexone: Daily dosing 100 mg for 24 weeks"
266388|NCT00006489|O4|Outcome|Placebo + Supportive Counseling|"Placebo alone
Placebo: Pill Placebo daily dosing 24 weeks"
266389|NCT00006489|O3|Outcome|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
266390|NCT00006489|O2|Outcome|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
Naltrexone: Daily dosing 100 mg for 24 weeks"
266391|NCT00006489|O1|Outcome|Naltrexone + Supportive Counseling|"Naltrexone alone
Naltrexone: Daily dosing 100 mg for 24 weeks"
266392|NCT00006489|E4|Reported Event|Placebo + Supportive Counseling|"Placebo alone
Placebo: Pill Placebo daily dosing 24 weeks"
266393|NCT00006489|E3|Reported Event|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
266394|NCT00006489|E2|Reported Event|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD
Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
Naltrexone: Daily dosing 100 mg for 24 weeks"
266395|NCT00006489|E1|Reported Event|Naltrexone + Supportive Counseling|"Naltrexone alone
Naltrexone: Daily dosing 100 mg for 24 weeks"
266396|NCT00006604|B8|Baseline|Total|Total of all reporting groups
266397|NCT00006604|B7|Baseline|Step I: Group 8 (ATV Final Dose: 205mg/m^2 Capsule + RTV)|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266398|NCT00006604|B6|Baseline|Step I: Group 7 (ATV Final Dose: 205mg/m^2 Capsule + RTV)|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266540|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
266399|NCT00006604|B5|Baseline|Step I: Group 6 (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266400|NCT00006604|B4|Baseline|Step I: Group 5a (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266401|NCT00006604|B3|Baseline|Step I: Group 5 (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266402|NCT00006604|B2|Baseline|Step I: Group 4 (ATV Final Dose: 620mg/m^2 Capsule)|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266403|NCT00006604|B1|Baseline|Step I: Group 3 (ATV Final Dose: 520mg/m^2 Capsule)|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266404|NCT00006604|P17|Participant Flow|Group 8: ATV Capsule (205mg/m^2) + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
Note: This is the final recommended dose for this group."
266405|NCT00006604|P16|Participant Flow|Group 8: ATV Capsule (310mg/m^2) + RTV|Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
266406|NCT00006604|P15|Participant Flow|Group 7: ATV Capsule (205mg/m^2) + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
Note: This is the final recommended dose for this group."
266407|NCT00006604|P14|Participant Flow|Group 7: ATV Capsule (310mg/m^2) + RTV|Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
266408|NCT00006604|P13|Participant Flow|Group 6: ATV Powder (310mg/m^2) + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
Note: This is the final recommended dose for this group."
266409|NCT00006604|P12|Participant Flow|Group 5a: ATV Powder (310mg/m^2) + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
Note: This is the final recommended dose for this group."
266410|NCT00006604|P11|Participant Flow|Group 5: ATV Powder (310mg/m^2) + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
Note: This is the final recommended dose for this group."
266411|NCT00006604|P10|Participant Flow|Group 4: ATV Capsule (620mg/m^2)|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
Note: This is the final recommended dose for this group."
266412|NCT00006604|P9|Participant Flow|Group 4: ATV Capsule (520mg/m^2)|Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
266413|NCT00006604|P8|Participant Flow|Group 4: ATV Capsule (310mg/m^2)|Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
266414|NCT00006604|P7|Participant Flow|Group 3: ATV Capsule (520mg/m^2)|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
Note: This is the final recommended dose for this group."
266415|NCT00006604|P6|Participant Flow|Group 3: ATV Capsule (415mg/m^2)|Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
266416|NCT00006604|P5|Participant Flow|Group 3: ATV Capsule (310mg/m^2)|Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They will received ATV (capsule) and two NRTIs.
266417|NCT00006604|P4|Participant Flow|Group 2: ATV Powder (620mg/m^2)|Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs.
266418|NCT00006604|P3|Participant Flow|Group 2: ATV Powder (310mg/m^2)|Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs.
266419|NCT00006604|P2|Participant Flow|Group 1: ATV Dose: Powder (620mg/m^2)|Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.
266420|NCT00006604|P1|Participant Flow|Group 1: ATV Dose: Powder (310mg/m^2)|Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.
266421|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266563|NCT00006903|O1|Outcome|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
266716|NCT00006170|B5|Baseline|Total|Total of all reporting groups
266422|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266423|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266424|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266425|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266426|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266427|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266428|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266429|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266430|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266431|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266432|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266433|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266434|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266435|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266564|NCT00006903|E1|Reported Event|Faslodex|"Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy.
Includes both Estrogen Receptor Positive and Estrogen Receptor Negative participants."
266436|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266437|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266438|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266439|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266440|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266441|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266442|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266443|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended: 205mg/m^2"
266444|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266445|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266446|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266447|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266448|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266449|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266591|NCT00007475|B3|Baseline|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant); group size is limited due to limited availability of validated FPF assay
268099|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
266450|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266451|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266452|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266453|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266454|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266455|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266456|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266457|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266458|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266459|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266460|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266461|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266462|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266463|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266592|NCT00007475|B2|Baseline|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
266464|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266465|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m2"
266466|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266467|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266468|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266469|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266470|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266471|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266472|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266473|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266474|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended: 310mg/m^2"
266475|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266476|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2 Capsule"
266477|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266625|NCT00008138|B1|Baseline|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
268100|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
266478|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266479|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266480|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266481|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266482|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266483|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266484|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266485|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266486|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266487|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266488|NCT00006604|O3|Outcome|Step I: Group 5: ATV 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266489|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266490|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266491|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266626|NCT00008138|P1|Participant Flow|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
268101|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
266492|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266493|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266494|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266495|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266496|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266497|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266498|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266499|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266500|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266501|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266502|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266503|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266504|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266505|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266627|NCT00008138|O1|Outcome|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
268102|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
266506|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended: 205mg/m^2"
266507|NCT00006604|O5|Outcome|Step I: Group 6 : ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266508|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266509|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266510|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266511|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266512|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266513|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266514|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266515|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266516|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266517|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266518|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266519|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266628|NCT00008138|O1|Outcome|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
268103|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
266520|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 205mg/m^2"
266521|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266522|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended: 310mg/m^2"
266523|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
Ritonavir: Administered as 100 mg capsules or oral solution.
ATV Final Recommended Dose: 310mg/m^2"
266524|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 620mg/m^2"
266525|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
ATV Final Recommended Dose: 520mg/m^2"
266526|NCT00006604|E7|Reported Event|Group 5A: ATV 310mg/m^2 Powder + RTV|"91 to 180 days of age.
ATV powder + ritonavir + 2 NRTIs
Note: This is the final recommended dose for this group."
266527|NCT00006604|E6|Reported Event|Group 8: ATV 205mg/m^2 Capsule + RTV|"13 years and 1 day to 21 (not including the 22nd birthday) years of age.
ATV capsule + ritonavir + 2 NRTIs
Note: This is the final recommended dose for this group."
266528|NCT00006604|E5|Reported Event|Group 7: ATV 205mg/m^2 Capsule + RTV|"2 years and 1 day (731 days or more) to 13 years of age.
ATV capsule + ritonavir + 2 NRTIs
Note: This is the final recommended dose for this group."
266529|NCT00006604|E4|Reported Event|Group 6: ATV 310mg/m^2 Powder + RTV|"2 years and 1 day (731 days or more) to 13 years of age.
ATV powder + ritonavir + 2 NRTIs
Note: This is the final recommended dose for this group."
266530|NCT00006604|E3|Reported Event|Group 5: ATV 310mg/m^2 Powder + RTV|"91 days to 2 years of age (less than or exactly 730 days.
ATV powder + ritonavir + 2 NRTIs
Note: This is the final recommended dose for this group."
266531|NCT00006604|E2|Reported Event|Group 4: ATV 620mg/m^2 Capsule|"13 years and 1 day to 21 (not including the 22nd birthday) years of age.
ATV capsule + 2 NRTIs
Note: This is the final recommended dose for this group."
266532|NCT00006604|E1|Reported Event|Group 3: ATV 520mg/m^2 Capsule|"2 years and 1 day (731 days or more) to 13 years of age.
ATV capsule + 2 NRTIs
Note: This is the final recommended dose for this group."
266533|NCT00006721|B4|Baseline|Total|Total of all reporting groups
266534|NCT00006721|B3|Baseline|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
266535|NCT00006721|B2|Baseline|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
266536|NCT00006721|B1|Baseline|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
266537|NCT00006721|P3|Participant Flow|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
266538|NCT00006721|P2|Participant Flow|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
266539|NCT00006721|P1|Participant Flow|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
266629|NCT00008138|E2|Reported Event|Post-Cytoreduction Paclitaxel (IV/IP) + Carboplatin (IP)|post-surgery chemotherapy with IV and IP carboplatin and paclitaxel
266630|NCT00008138|E1|Reported Event|Neoadjuvant Paclitaxel (IV) + Carboplatin (V)|Pre-surgery IV chemotherapy with paclitaxel and carboplatin
266541|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
266542|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
266543|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
266544|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
266545|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
266546|NCT00006721|O3|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
266547|NCT00006721|O2|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
266548|NCT00006721|O1|Outcome|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the abs ence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
266549|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
266550|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
266551|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
266552|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
266553|NCT00006721|E3|Reported Event|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
266554|NCT00006721|E2|Reported Event|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
266555|NCT00006721|E1|Reported Event|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
266556|NCT00006903|B3|Baseline|Total|Total of all reporting groups
266557|NCT00006903|B2|Baseline|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
266558|NCT00006903|B1|Baseline|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
266559|NCT00006903|P3|Participant Flow|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
266560|NCT00006903|P2|Participant Flow|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
266561|NCT00006903|P1|Participant Flow|Ineligible|Not eligible
266562|NCT00006903|O2|Outcome|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
266565|NCT00006916|B1|Baseline|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
266566|NCT00006916|P1|Participant Flow|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
266567|NCT00006916|O1|Outcome|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
266568|NCT00006916|E1|Reported Event|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
266569|NCT00007345|B3|Baseline|Total|Total of all reporting groups
266570|NCT00007345|B2|Baseline|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266571|NCT00007345|B1|Baseline|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266572|NCT00007345|P2|Participant Flow|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266573|NCT00007345|P1|Participant Flow|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266574|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266575|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266576|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266577|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266578|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266579|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266580|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266581|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266582|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266583|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266584|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266585|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266586|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266587|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266588|NCT00007345|E2|Reported Event|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266589|NCT00007345|E1|Reported Event|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
266590|NCT00007475|B4|Baseline|Total|Total of all reporting groups
266593|NCT00007475|B1|Baseline|FPF NOT Assayed Provisionally, PE + Cyclophosphamide Completed|Participants not provisionally assayed for FPF, yet still complete both series of protocol treatment: Plasma Exchange (PE) and Cyclophosphamide; note that these form a majority of enrollees due to limited availability of validated FPF assay (such an assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial; see Outcome Measures for more details)
266594|NCT00007475|P4|Participant Flow|Historical Controls|Noted as Group F in study protocol: historical control patients, including patients at NIH or other institutions who have previously undergone renal transplant, for whom stored sera are available, and for whom consent to measure FPF has been can be obtained. In some cases, these measurements have been performed by Dr. Savin under pre-existing protocols and these data are already available.
266595|NCT00007475|P3|Participant Flow|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant); group size is limited due to limited availability of provisionally validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
266596|NCT00007475|P2|Participant Flow|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of provisionally validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
266597|NCT00007475|P1|Participant Flow|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants not assayed for FSGS Permeability Factor (FPF) levels pre-treatment (Tx), yet still complete both series of protocol-specified treatment; FPF levels NOT available as its assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial
266598|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
266599|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
266600|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
266601|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
266602|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
266603|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
266604|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
266605|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
266606|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
266607|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
266608|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
266609|NCT00007475|O1|Outcome|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants complete both series of protocol treatment: Plasma Exchange + Cyclophosphamide
266610|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
266611|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
266612|NCT00007475|O1|Outcome|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants complete both series of protocol treatment, Plasma Exchange and Cyclophosphamide.
266613|NCT00007475|E3|Reported Event|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Original protocol Group D (FPF 0.6 or greater pre-initial Transplant)
266614|NCT00007475|E2|Reported Event|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Original protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
266615|NCT00007475|E1|Reported Event|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants for whom the Focal Segmental Glomerulosclerosis (FSGS) Permeability Factor, or FPF was not able to be assayed, yet enrolled and completed both protocol-specified interventions: the plasma exchange procedure and treatment by cyclophosphamide.
266616|NCT00007644|B3|Baseline|Total|Total of all reporting groups
266617|NCT00007644|B2|Baseline|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
266618|NCT00007644|B1|Baseline|Radical Prostatectomy|Surgical removal of the prostate
266619|NCT00007644|P2|Participant Flow|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
266620|NCT00007644|P1|Participant Flow|Radical Prostatectomy|Surgical removal of the prostate
266621|NCT00007644|O2|Outcome|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
266622|NCT00007644|O1|Outcome|Radical Prostatectomy|Surgical removal of the prostate
266623|NCT00007644|E2|Reported Event|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
266624|NCT00007644|E1|Reported Event|Radical Prostatectomy|Surgical removal of the prostate
266631|NCT00008385|B3|Baseline|Total|Total of all reporting groups
266632|NCT00008385|B2|Baseline|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.
selenium: Given orally"
266633|NCT00008385|B1|Baseline|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.
placebo: Given orally"
266634|NCT00008385|P2|Participant Flow|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.
selenium: Given orally"
266635|NCT00008385|P1|Participant Flow|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.
placebo: Given orally"
266636|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.
selenium: Given orally"
266637|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.
placebo: Given orally"
266638|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.
selenium: Given orally"
266639|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.
placebo: Given orally"
266640|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.
selenium: Given orally"
266641|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.
placebo: Given orally"
266642|NCT00008385|E2|Reported Event|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.
selenium: Given orally"
266643|NCT00008385|E1|Reported Event|Arm I (Placebo)|Participants receive an oral yeast placebo as in arm II. placebo: Given orally
266644|NCT00006011|B4|Baseline|Total|Total of all reporting groups
266645|NCT00006011|B3|Baseline|Radiation (RT) Only|Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
266646|NCT00006011|B2|Baseline|Arm 2|"Treatment randomization following RT:
radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
266647|NCT00006011|B1|Baseline|Arm 1|"Treatment randomization following RT.
radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
266648|NCT00006011|P3|Participant Flow|Radiation (RT) Only|Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
266649|NCT00006011|P2|Participant Flow|Arm 2|"Treatment randomization following RT:
radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
266650|NCT00006011|P1|Participant Flow|Arm 1|"Treatment randomization following RT.
radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
266651|NCT00006011|O2|Outcome|Arm 2|"Treatment randomization following RT:
doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
266652|NCT00006011|O1|Outcome|Arm 1|"Treatment randomization following RT.
doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
266653|NCT00006011|E2|Reported Event|Arm 2|"Treatment randomization following RT:
doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
266654|NCT00006011|E1|Reported Event|Arm 1|"Treatment randomization following RT.
doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
266655|NCT00006110|B3|Baseline|Total|Total of all reporting groups
266656|NCT00006110|B2|Baseline|Experimental: Non-Herceptin With or Without Radiation|Patients with high-risk human epidermal growth factor receptor 2 (HER-2) non-overexpressing tumors and those whose tumors overexpress the protein but who refuse or are ineligible for Herceptin® will be treated with conventional Adriamycin/Cytoxan (4AC) followed by Taxol® without Herceptin®. This will be followed by surgery then either radiation or no radiation.
266657|NCT00006110|B1|Baseline|Experimental: Herceptin With or Without Radiation|Patients will receive Adriamycin/Cytoxan (4AC) followed by Taxol plus weekly Herceptin either neo-adjuvantly or adjuvantly. Eligible patients will go on to radiation then all patients will receive additional Herceptin every three weeks for 40 weeks.
266658|NCT00006110|P2|Participant Flow|Experimental: Non-Herceptin With or Without Radiation|Patients with high-risk human epidermal growth factor receptor 2 (HER-2) non-overexpressing tumors and those whose tumors overexpress the protein but who refuse or are ineligible for Herceptin® will be treated with conventional 4AC followed by Taxol® without Herceptin®. This will be followed by surgery then either radiation or no radiation.
266659|NCT00006110|P1|Participant Flow|Experimental: Herceptin With or Without Radiation|Patients will receive Adriamycin/Cytoxan (4AC) followed by Taxol plus weekly Herceptin either neo-adjuvantly or adjuvantly. Eligible patients will go on to radiation then all patients will receive additional Herceptin every three weeks for 40 weeks.
266660|NCT00006110|O2|Outcome|Experimental: Non-Herceptin With or Without Radiation|Patients treated with AC chemotherapy followed by Taxol followed by surgery followed by radiation (or no radiation)
266661|NCT00006110|O1|Outcome|Experimental: Herceptin With or Without Radiation|Patients who were given [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide) followed by paclitaxel + herceptin in both the neoadjuvant and the adjuvant groups.
266662|NCT00006110|O2|Outcome|Patients Treated With AC-P (Without Herceptin)|Patients treated with AC chemotherapy followed by Taxol followed by surgery followed by radiation (or no radiation)
266663|NCT00006110|O1|Outcome|Patients Treated Neoadjuvantly With AC-TP|Patients who were given [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide) followed by paclitaxel + herceptin followed by surgery followed by radiation or no radiation followed by herceptin.
266664|NCT00006110|O4|Outcome|Herceptin Regimen|Worst per-patient toxicity: represents the number of patients who had cardiac toxicity at any time during the study regardless of subsequent recovery of function.
266665|NCT00006110|O3|Outcome|Herceptin Regimen at 1.5 Years|Patients in the adjuvant and neoadjuvant groups.
266666|NCT00006110|O2|Outcome|Herceptin Regimen After TP|Patients in the adjuvant and neoadjuvant groups after receiving chemotherapy and Taxol + Herceptin.
266667|NCT00006110|O1|Outcome|Herceptin Regimen After AC|Patients in the adjuvant and neoadjuvant groups after receiving [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide).
266668|NCT00006110|E2|Reported Event|Control: Non-Herceptin|Patients with high-risk HER-2 non-overexpressing tumors and those whose tumors overexpress the protein but who refuse or are ineligible for Herceptin® will be treated with conventional 4AC followed by Taxol® without Herceptin®. This will be followed by surgery then either radiation or no radiation.
266669|NCT00006110|E1|Reported Event|Chemotherapy + Herceptin|Patients will receive Adriamycin/Cytoxan (4AC) followed by Taxol plus weekly Herceptin either neo-adjuvantly or adjuvantly. Eligible patients will go on to radiation then all patients will receive additional Herceptin every three weeks for 40 weeks.
266670|NCT00006151|B3|Baseline|Total|Total of all reporting groups
266671|NCT00006151|B2|Baseline|Placebo Accu Drop Plus Counseling|Placebo product and systematic cigarette tapering plus counseling
266672|NCT00006151|B1|Baseline|Accu Drop Plus Counseling|Active product and systematic cigarette tapering plus counseling.
266673|NCT00006151|P2|Participant Flow|Placebo (PD&C)|The control condition (N=30) will be prescribed placebo Accu Drops (PD&C)
266674|NCT00006151|P1|Participant Flow|Accu Drops (AD&C)|The experimental group (N=30) will be prescribed active Accu Drops (AD&C)
266675|NCT00006151|O2|Outcome|Placebo Accu Drop Plus Counseling|Placebo product and systematic cigarette tapering plus counseling
266676|NCT00006151|O1|Outcome|Accu Drop Plus Counseling|Active product and systematic cigarette tapering plus counseling.
266677|NCT00006151|E2|Reported Event|Placebo (PD&C)|The control condition (N=30) will be prescribed placebo Accu Drops (PD&C)
266678|NCT00006151|E1|Reported Event|Accu Drops (AD&C)|The experimental group (N=30) will be prescribed active Accu Drops (AD&C)
266679|NCT00006156|B3|Baseline|Total|Total of all reporting groups
266680|NCT00006156|B2|Baseline|Control|
266681|NCT00006156|B1|Baseline|Drug - FSH|
266682|NCT00006156|P2|Participant Flow|Control|
266683|NCT00006156|P1|Participant Flow|Drug - FSH|
266684|NCT00006156|O2|Outcome|Control|
266685|NCT00006156|O1|Outcome|Drug - FSH|
266686|NCT00006156|O2|Outcome|Control|
266687|NCT00006156|O1|Outcome|Drug - FSH|
266688|NCT00006156|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
266689|NCT00006164|B3|Baseline|Total|Total of all reporting groups
266690|NCT00006164|B2|Baseline|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266691|NCT00006164|B1|Baseline|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266692|NCT00006164|P2|Participant Flow|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266693|NCT00006164|P1|Participant Flow|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266694|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266695|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266696|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266697|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266698|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266699|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266700|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266701|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266702|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266703|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266704|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266705|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266706|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266707|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266708|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266709|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266710|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266711|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266712|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266713|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
266714|NCT00006164|E2|Reported Event|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
266717|NCT00006170|B4|Baseline|SS+P|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
266718|NCT00006170|B3|Baseline|SS+B|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
266719|NCT00006170|B2|Baseline|WC+P|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of bupropion.
266720|NCT00006170|B1|Baseline|WC+B|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
266721|NCT00006170|P4|Participant Flow|Social Support + Placebo (SS+P)|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
266722|NCT00006170|P3|Participant Flow|Social Support + Bupropion (SS+B)|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
266723|NCT00006170|P2|Participant Flow|Weight Concerns + Placebo (WC+P)|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of the bupropion.
266724|NCT00006170|P1|Participant Flow|Weight Concerns + Bupropion (WC+B)|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
266725|NCT00006170|O4|Outcome|SS+P|
266726|NCT00006170|O3|Outcome|SS+B|
266727|NCT00006170|O2|Outcome|WC+P|
266728|NCT00006170|O1|Outcome|WC+B|
266729|NCT00006170|O4|Outcome|SS+P|
266730|NCT00006170|O3|Outcome|SS+B|
266731|NCT00006170|O2|Outcome|WC+P|
266732|NCT00006170|O1|Outcome|WC+B|
266733|NCT00006170|O4|Outcome|SS+P|
266734|NCT00006170|O3|Outcome|SS+B|
266735|NCT00006170|O2|Outcome|WC+P|
266736|NCT00006170|O1|Outcome|WC+B|
266737|NCT00006170|E4|Reported Event|SS+P|
266738|NCT00006170|E3|Reported Event|SS+B|
266739|NCT00006170|E2|Reported Event|WC+P|
266740|NCT00006170|E1|Reported Event|WC+B|
266741|NCT00006178|B1|Baseline|Sirolimus Monotherapy|
266742|NCT00006178|P1|Participant Flow|Sirolimus Monotherapy|
266743|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
266744|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
266745|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
266746|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
266747|NCT00006178|E1|Reported Event|Sirolimus Monotherapy|
266748|NCT00006184|B3|Baseline|Total|Total of all reporting groups
266749|NCT00006184|B2|Baseline|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
266750|NCT00006184|B1|Baseline|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
266751|NCT00006184|P2|Participant Flow|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (Anti-idiotype-keyhole limpet hemocyanin) (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
266752|NCT00006184|P1|Participant Flow|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor ( GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
266753|NCT00006184|O2|Outcome|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
266754|NCT00006184|O1|Outcome|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
266755|NCT00006184|O1|Outcome|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
266756|NCT00006184|E2|Reported Event|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
266757|NCT00006184|E1|Reported Event|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
266758|NCT00014495|B5|Baseline|Total|Total of all reporting groups
266759|NCT00014495|B4|Baseline|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266760|NCT00014495|B3|Baseline|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266761|NCT00014495|B2|Baseline|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266762|NCT00014495|B1|Baseline|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266763|NCT00014495|P4|Participant Flow|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266764|NCT00014495|P3|Participant Flow|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266765|NCT00014495|P2|Participant Flow|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266766|NCT00014495|P1|Participant Flow|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266767|NCT00014495|O1|Outcome|Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
Patients are followed twice weekly for 4 weeks and then monthly for 3 months
filgrastim
cytarabine
bismuth Bi213 monoclonal antibody M195"
266789|NCT00015457|O1|Outcome|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
266790|NCT00015457|O2|Outcome|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
266791|NCT00015457|O1|Outcome|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
266792|NCT00015457|E2|Reported Event|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
266768|NCT00014495|E4|Reported Event|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266769|NCT00014495|E3|Reported Event|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266770|NCT00014495|E2|Reported Event|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266771|NCT00014495|E1|Reported Event|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
266772|NCT00014560|B1|Baseline|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
266773|NCT00014560|P1|Participant Flow|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
266774|NCT00014560|O1|Outcome|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
266775|NCT00014560|E1|Reported Event|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
266776|NCT00014911|B1|Baseline|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:
Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.
Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
266777|NCT00014911|P1|Participant Flow|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:
Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.
Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
266793|NCT00015457|E1|Reported Event|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
266794|NCT00015847|B1|Baseline|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
266778|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:
Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.
Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
266779|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:
Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.
Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
266780|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:
Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.
Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
266781|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:
Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.
Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
266782|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:
Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.
Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
266783|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:
Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.
Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
266784|NCT00014911|E1|Reported Event|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:
Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.
Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
266785|NCT00015457|B1|Baseline|Cervical Dystonia|All participants enrolled in study
266786|NCT00015457|P2|Participant Flow|Placebo Then Amlodipine|Patients with cervical dystonia receiving botulinum toxin injections plus Placebo during the first period and botulinum toxin injections plus Amlodipine during the second period.
266787|NCT00015457|P1|Participant Flow|Amlodipine Then Placebo|Patients with cervical dystonia receiving botulinum toxin injections plus Amlodipine during the first period and botulinum toxin injections plus Placebo during the second period.
266788|NCT00015457|O2|Outcome|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
266795|NCT00015847|P1|Participant Flow|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
266796|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
266797|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
266798|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
266799|NCT00015847|E1|Reported Event|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
266800|NCT00016354|B1|Baseline|Benzoylphenylurea|BPU, administered over a dose range of 5–320 mg
266801|NCT00016354|P8|Participant Flow|Benzoylphenylurea Dose Level of 150 mg|Benzoylphenylurea dose level of 150 mg; Dose level 8 (for this dose level, a 25 mg capsule was used. At all previous dose levels, a 5 mg capsule was administered.)
266802|NCT00016354|P7|Participant Flow|Benzoylphenylurea 320 mg|Benzoylphenylurea dose level of 320 mg; Dose level 7
266803|NCT00016354|P6|Participant Flow|Benzoylphenylurea 160 mg|Benzoylphenylurea dose level of 160 mg; Dose level 6
266804|NCT00016354|P5|Participant Flow|Benzoylphenylurea 80 mg|Benzoylphenylurea dose level of 80 mg; Dose level 5
266805|NCT00016354|P4|Participant Flow|Benzoylphenylurea 40 mg|Benzoylphenylurea dose level of 40 mg; Dose level 4
266806|NCT00016354|P3|Participant Flow|Benzoylphenylurea 20 mg|Benzoylphenylurea dose level of 20 mg; Dose level 3
266807|NCT00016354|P2|Participant Flow|Benzoylphenylurea 10 mg|Benzoylphenylurea dose level of 10 mg; Dose level 2
266808|NCT00016354|P1|Participant Flow|Benzoylphenylurea 5 mg|Benzoylphenylurea dose level of 5 mg; Dose level 1
266809|NCT00016354|O1|Outcome|Benzoylphenylurea|BPU, administered over a dose range of 5-320 mg
266810|NCT00016354|E1|Reported Event|Benzoylphenylurea|BPU, administered over a dose range of 5-320 mg
266811|NCT00016913|B1|Baseline|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
266812|NCT00016913|P1|Participant Flow|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
266813|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
266814|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
266815|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
266816|NCT00016913|E1|Reported Event|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer.
266817|NCT00018031|B1|Baseline|Peg-interefron Alfa 2b, Ribavirin|"Weekly Injection
Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously
Oral Pills
Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
266818|NCT00018031|P1|Participant Flow|Peginterferon Alfa-2b, Ribavirin|"Weekly Injection (Peginterferon alfa-2b)
Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously
Oral Pills (Ribavirin)
Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
266819|NCT00018031|O1|Outcome|Peginterferon Alfa-2b, Ribavirin|"Weekly Injection (Peginterferon alfa-2b)
Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously
Oral Pills (Ribavirin)
Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
266820|NCT00018031|E1|Reported Event|Peg-interefron Alfa 2b, Ribavirin|"Weekly Injection
Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously
Oral Pills
Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
266821|NCT00019604|B1|Baseline|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266822|NCT00019604|P1|Participant Flow|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266823|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266824|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266825|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266826|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266827|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266828|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
268104|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
266829|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266830|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266831|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266832|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266833|NCT00019604|E1|Reported Event|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
266834|NCT00019747|B3|Baseline|Total|Total of all reporting groups
266835|NCT00019747|B2|Baseline|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
266836|NCT00019747|B1|Baseline|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
266837|NCT00019747|P2|Participant Flow|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
266838|NCT00019747|P1|Participant Flow|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
266839|NCT00019747|O2|Outcome|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
266840|NCT00019747|O1|Outcome|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
266841|NCT00019747|E2|Reported Event|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
266842|NCT00019747|E1|Reported Event|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
266843|NCT00020722|B1|Baseline|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.
The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.
Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.
Mesna administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 mins. prior to and then 3, 6, and 9 hrs after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
266844|NCT00020722|P1|Participant Flow|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.
Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.
Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
266845|NCT00020722|O1|Outcome|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.
The time for ATC infusions will vary from patient to patient, but the infusion rate will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.
Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.
Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 mg/m2.
Carboplatin at a dose of"
266846|NCT00020722|O1|Outcome|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.
The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.
Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.
Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
266875|NCT00011986|P3|Participant Flow|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
266876|NCT00011986|P2|Participant Flow|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
266877|NCT00011986|P1|Participant Flow|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
268105|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
266847|NCT00020722|E1|Reported Event|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.
Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.
Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
266848|NCT00009737|B3|Baseline|Total|Total of all reporting groups
266849|NCT00009737|B2|Baseline|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
266850|NCT00009737|B1|Baseline|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
266851|NCT00009737|P2|Participant Flow|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
266852|NCT00009737|P1|Participant Flow|Capecitabine|Participants received capecitabine 1250 milligram per square meter (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
266853|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
266854|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
266855|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
266856|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
266857|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
266858|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
266859|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
266860|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
266861|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
266862|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
266863|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
266864|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
266865|NCT00009737|E2|Reported Event|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
266866|NCT00009737|E1|Reported Event|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
266867|NCT00011986|B6|Baseline|Total|Total of all reporting groups
266868|NCT00011986|B5|Baseline|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
266869|NCT00011986|B4|Baseline|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
266870|NCT00011986|B3|Baseline|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
266871|NCT00011986|B2|Baseline|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
266872|NCT00011986|B1|Baseline|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
266873|NCT00011986|P5|Participant Flow|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
266874|NCT00011986|P4|Participant Flow|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
266878|NCT00011986|O5|Outcome|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
266879|NCT00011986|O4|Outcome|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
266880|NCT00011986|O3|Outcome|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
266881|NCT00011986|O2|Outcome|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
266882|NCT00011986|O1|Outcome|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
266883|NCT00011986|E5|Reported Event|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
266884|NCT00011986|E4|Reported Event|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
266885|NCT00011986|E3|Reported Event|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
266886|NCT00011986|E2|Reported Event|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
266887|NCT00011986|E1|Reported Event|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
266888|NCT00012012|B3|Baseline|Total|Total of all reporting groups
266889|NCT00012012|B2|Baseline|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
266890|NCT00012012|B1|Baseline|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
266891|NCT00012012|P2|Participant Flow|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
266892|NCT00012012|P1|Participant Flow|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
266893|NCT00012012|O1|Outcome|Radiation Therapy Plus Cisplatin and Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
266894|NCT00012012|O1|Outcome|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
266895|NCT00012012|E2|Reported Event|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
266896|NCT00012012|E1|Reported Event|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
266897|NCT00012298|B8|Baseline|Total|Total of all reporting groups
266898|NCT00012298|B7|Baseline|Treatment : Phase II (Dose Level 6)|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
266899|NCT00012298|B6|Baseline|Treatment: Trial 3, Dose Level 6|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
266900|NCT00012298|B5|Baseline|Treatment: Trial 3, Dose Level 5|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
266901|NCT00012298|B4|Baseline|Treatment: Trial 2, Dose Level 4|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
268106|NCT00041938|E2|Reported Event|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
266902|NCT00012298|B3|Baseline|Treatment: Trial 2, Dose Level 3|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
266903|NCT00012298|B2|Baseline|Treatment: Trial 1, Dose Level 2|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
266904|NCT00012298|B1|Baseline|Treatment: Trial 1, Dose Level 1|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
266905|NCT00012298|P7|Participant Flow|Treatment : Phase II (Dose Level 6)|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
266906|NCT00012298|P6|Participant Flow|Treatment: Trial 3, Dose Level 6|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
266907|NCT00012298|P5|Participant Flow|Treatment: Trial 3, Dose Level 5|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
266908|NCT00012298|P4|Participant Flow|Treatment: Trial 2, Dose Level 4|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
266909|NCT00012298|P3|Participant Flow|Treatment: Trial 2, Dose Level 3|"Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
266910|NCT00012298|P2|Participant Flow|Treatment: Trial 1, Dose Level 2|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
266911|NCT00012298|P1|Participant Flow|Treatment: Trial 1, Dose Level 1|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
266912|NCT00012298|O1|Outcome|Treatment : Dose Level 6|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
268107|NCT00041938|E1|Reported Event|Aspirin|Aspirin : 325 mg per day
266913|NCT00012298|O6|Outcome|Treatment: Trial 3, Dose Level 6|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
266914|NCT00012298|O5|Outcome|Treatment: Trial 3, Dose Level 5|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
266915|NCT00012298|O4|Outcome|Treatment: Trial 2, Dose Level 4|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
266916|NCT00012298|O3|Outcome|Treatment: Trial 2, Dose Level 3|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
266917|NCT00012298|O2|Outcome|Treatment: Trial 1, Dose Level 2|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
266918|NCT00012298|O1|Outcome|Treatment: Trial 1, Dose Level 1|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
266919|NCT00012298|O6|Outcome|Treatment: Trial 3, Dose Level 6|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
266920|NCT00012298|O5|Outcome|Treatment: Trial 3, Dose Level 5|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
266921|NCT00012298|O4|Outcome|Treatment: Trial 2, Dose Level 4|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
266922|NCT00012298|O3|Outcome|Treatment: Trial 2, Dose Level 3|"Patients receive:
Cycle 1:
50 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
Patients also receive:
480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.
50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
266923|NCT00012298|O2|Outcome|Treatment: Trial 1, Dose Level 2|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
266924|NCT00012298|O1|Outcome|Treatment: Trial 1, Dose Level 1|"Patients receive:
Cycle 1:
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):
250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
266925|NCT00012298|E7|Reported Event|Treatment : Phase II (Dose Level 6)|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
266926|NCT00012298|E6|Reported Event|Treatment: Trial 3, Dose Level 6|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
266927|NCT00012298|E5|Reported Event|Treatment: Trial 3, Dose Level 5|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
266928|NCT00012298|E4|Reported Event|Treatment: Trial 2, Dose Level 4|50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
266929|NCT00012298|E3|Reported Event|Treatment: Trial 2, Dose Level 3|50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
266930|NCT00012298|E2|Reported Event|Treatment: Trial 1, Dose Level 2|0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
266931|NCT00012298|E1|Reported Event|Treatment: Trial 1, Dose Level 1|0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
266932|NCT00013611|B3|Baseline|Total|Total of all reporting groups
266933|NCT00013611|B2|Baseline|Antiretroviral Therapy Only|
266934|NCT00013611|B1|Baseline|Proleukin Plus Antiretroviral Therapy|
266935|NCT00013611|P2|Participant Flow|Antiretroviral Therapy Only|All patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used.
266936|NCT00013611|P1|Participant Flow|Proleukin Plus Antiretroviral Therapy|Patients receive an initial dose of 4.5 MIU of proleukin twice daily for 5 consecutive days every 8 weeks during the first year (6 cycles total). After the first year, additional cycles are given to either achieve or maintain the patient's CD4+ count goal. CD4+ goal is defined as an increase of 125 cells/cubic mm for participants in the 50-199 CD4+ count stratum, and an increase of 175 cells/cubic mm for participants in the 200-299 CD4+ stratum. In addition, all patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used. All patients must take antiretroviral therapy during each 5-consecutive-day treatment cycle.
266937|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
266938|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
266939|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
266940|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
266941|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
266942|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
266943|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
266944|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
266945|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
266946|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
266947|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
266948|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
266949|NCT00013611|E2|Reported Event|Antiretroviral Therapy Only|
266950|NCT00013611|E1|Reported Event|Proleukin Plus Antiretroviral Therapy|
266951|NCT00021229|B4|Baseline|Total|Total of all reporting groups
266952|NCT00021229|B3|Baseline|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
266953|NCT00021229|B2|Baseline|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
266954|NCT00021229|B1|Baseline|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
267058|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
267072|NCT00025662|B1|Baseline|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
266955|NCT00021229|P3|Participant Flow|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
266956|NCT00021229|P2|Participant Flow|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
266957|NCT00021229|P1|Participant Flow|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
266958|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
266959|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
266960|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
266961|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
266962|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
266963|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
267070|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
266964|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
266965|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
266966|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
266967|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
266968|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
266969|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
266970|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
266971|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
266972|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
267071|NCT00025506|E1|Reported Event|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
266973|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
266974|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
266975|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
266976|NCT00021229|O2|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
266977|NCT00021229|O1|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
266978|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
266979|NCT00021229|E3|Reported Event|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
266980|NCT00021229|E2|Reported Event|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.
Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).
Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
266995|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
268108|NCT00042224|B3|Baseline|Total|Total of all reporting groups
266981|NCT00021229|E1|Reported Event|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.
Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.
Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.
Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.
Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
266982|NCT00021255|B4|Baseline|Total|Total of all reporting groups
266983|NCT00021255|B3|Baseline|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
266984|NCT00021255|B2|Baseline|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
266985|NCT00021255|B1|Baseline|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
266986|NCT00021255|P3|Participant Flow|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
266987|NCT00021255|P2|Participant Flow|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
266988|NCT00021255|P1|Participant Flow|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
266989|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
266990|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
266991|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
266992|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
266993|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
266994|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
267049|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT ( Reduced Therapy Arm)
266996|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
266997|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
266998|NCT00021255|E3|Reported Event|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
266999|NCT00021255|E2|Reported Event|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
267000|NCT00021255|E1|Reported Event|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
267001|NCT00024258|B1|Baseline|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 1 year and then annually thereafter."
267002|NCT00024258|P1|Participant Flow|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 1 year and then annually thereafter."
267003|NCT00024258|O1|Outcome|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 1 year and then annually thereafter."
267004|NCT00024258|E1|Reported Event|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 1 year and then annually thereafter."
267005|NCT00025155|B1|Baseline|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
267006|NCT00025155|P1|Participant Flow|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
267007|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
267008|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
267009|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
267010|NCT00025155|E1|Reported Event|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
267011|NCT00025233|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267012|NCT00025233|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267013|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267014|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267015|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267016|NCT00025233|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267017|NCT00025259|B8|Baseline|Total|Total of all reporting groups
267050|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
267051|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
267052|NCT00025259|O7|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
267053|NCT00025259|O6|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
267018|NCT00025259|B7|Baseline|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267019|NCT00025259|B6|Baseline|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
Bleomycin Sulfate: Given IV or SC
Cisplatin: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Pre"
267020|NCT00025259|B5|Baseline|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267021|NCT00025259|B4|Baseline|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267022|NCT00025259|B3|Baseline|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267023|NCT00025259|B2|Baseline|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267024|NCT00025259|B1|Baseline|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267025|NCT00025259|P7|Participant Flow|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267054|NCT00025259|O5|Outcome|Arm V (RER With PD)|RER with Progressive Disease - Off Therapy
267055|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
267056|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT (Reduced Therapy Arm)
267057|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
267026|NCT00025259|P6|Participant Flow|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
Bleomycin Sulfate: Given IV or SC
Cisplatin: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Pre"
267027|NCT00025259|P5|Participant Flow|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267028|NCT00025259|P4|Participant Flow|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267029|NCT00025259|P3|Participant Flow|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267030|NCT00025259|P2|Participant Flow|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267031|NCT00025259|P1|Participant Flow|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267032|NCT00025259|O6|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
267033|NCT00025259|O5|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
267034|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
267035|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT ( Reduced Therapy Arm)
267036|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
267037|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
267038|NCT00025259|O7|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
267039|NCT00025259|O6|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
267040|NCT00025259|O5|Outcome|Arm V (RER With PD)|RER with Progressive Disease - Off Therapy
267041|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
267042|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT ( Reduced Therapy Arm)
267043|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
267044|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
267045|NCT00025259|O7|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
267046|NCT00025259|O6|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
267047|NCT00025259|O5|Outcome|Arm V (RER With PD)|RER with Progressive Disease - Off Therapy
267048|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
268193|NCT00042991|E6|Reported Event|Stratum IB at Dose 375 mg/m^2|Patients with STMG treated at 375 mg/m2
267059|NCT00025259|E7|Reported Event|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267060|NCT00025259|E6|Reported Event|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
Bleomycin Sulfate: Given IV or SC
Cisplatin: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Pre"
267061|NCT00025259|E5|Reported Event|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267062|NCT00025259|E4|Reported Event|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267063|NCT00025259|E3|Reported Event|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267064|NCT00025259|E2|Reported Event|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Involved-Field Radiation Therapy: Undergo IFRT
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267065|NCT00025259|E1|Reported Event|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.
Bleomycin Sulfate: Given IV or SC
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Prednisone: Given orally
Vincristine Sulfate Liposome: Given IV"
267066|NCT00025506|B1|Baseline|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
267067|NCT00025506|P1|Participant Flow|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
267068|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
267069|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
267159|NCT00010439|O1|Outcome|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
267073|NCT00025662|P1|Participant Flow|"RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants"|"Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults"
267074|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
267075|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
267076|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
267077|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
267078|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
267079|NCT00025662|E1|Reported Event|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
267080|NCT00025883|B3|Baseline|Total|Total of all reporting groups
267081|NCT00025883|B2|Baseline|Metreleptin With Patial Lipodystrophy|patients with partial lipodystrophy with subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
267082|NCT00025883|B1|Baseline|Metreleptin With Generalized Lipodystrophy|patients with generalized lipodystrophy with subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
267083|NCT00025883|P1|Participant Flow|Metreleptin|subcutaneous metreleptin injections in one to two daily doses ranging from 0.06 to 0.24 mg/kg/day.
267084|NCT00025883|O2|Outcome|Partial Lipodystrophy (PLD)|patients with partial lipodystrophy (PLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
267085|NCT00025883|O1|Outcome|Generalized Lipodystrophy (GLD)|patients with generalized lipodystrophy (GLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
267086|NCT00025883|O2|Outcome|Partial Lipodystrophy (PLD)|patients with partial lipodystrophy (PLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
267087|NCT00025883|O1|Outcome|Generalized Lipodystrophy (GLD)|patients with generalized lipodystrophy (GLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
267088|NCT00025883|E1|Reported Event|Metreleptin|subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
267089|NCT00026221|B4|Baseline|Total|Total of all reporting groups
267090|NCT00026221|B3|Baseline|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267091|NCT00026221|B2|Baseline|Arm II (Monoclonal Antibody)|"Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV"
267092|NCT00026221|B1|Baseline|Arm I (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267093|NCT00026221|P3|Participant Flow|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267094|NCT00026221|P2|Participant Flow|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV"
267095|NCT00026221|P1|Participant Flow|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267096|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267097|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV"
267098|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267099|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267100|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV"
267101|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267102|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267103|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV"
267104|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267105|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267106|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV"
267107|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267108|NCT00026221|E3|Reported Event|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267109|NCT00026221|E2|Reported Event|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV"
267110|NCT00026221|E1|Reported Event|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV"
267111|NCT00026312|B3|Baseline|Total|Total of all reporting groups
267112|NCT00026312|B2|Baseline|Regimen B|Regimen B - RA + Immunotherapy
267113|NCT00026312|B1|Baseline|Regimen A|Randomized to Regimen A - RA Only
267114|NCT00026312|P2|Participant Flow|Regimen B|Regimen B – RA + Immunotherapy
267115|NCT00026312|P1|Participant Flow|Regimen A|Randomized to Regimen A – RA Only
267116|NCT00026312|O1|Outcome|Regimen B|Non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease
267117|NCT00026312|O2|Outcome|Regimen B|Randomized to Regimen B - RA + Immunotherapy
267118|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
267119|NCT00026312|O1|Outcome|Regimen B|Regimen B- RA + Immunotherapy
267120|NCT00026312|O2|Outcome|Regimen B|Patients that received RA + Immunotherapy before halting of randomization
267121|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
267122|NCT00026312|O1|Outcome|Regimen B|Non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease
267123|NCT00026312|O2|Outcome|Regimen B|Regimen B - RA + Immunotherapy
267124|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
267125|NCT00026312|O2|Outcome|Regimen B|Randomized to Regimen B - RA + Immunotherapy
267126|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
267127|NCT00026312|E2|Reported Event|Regimen B|Regimen B – RA + Immunotherapy
267128|NCT00026312|E1|Reported Event|Regimen A|Randomized to Regimen A - RA Only
267129|NCT00026494|B5|Baseline|Total|Total of all reporting groups
267130|NCT00026494|B4|Baseline|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267131|NCT00026494|B3|Baseline|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267132|NCT00026494|B2|Baseline|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267133|NCT00026494|B1|Baseline|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267134|NCT00026494|P4|Participant Flow|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267135|NCT00026494|P3|Participant Flow|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267136|NCT00026494|P2|Participant Flow|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267137|NCT00026494|P1|Participant Flow|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267138|NCT00026494|O4|Outcome|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267139|NCT00026494|O3|Outcome|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267140|NCT00026494|O2|Outcome|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267141|NCT00026494|O1|Outcome|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267142|NCT00026494|E4|Reported Event|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267143|NCT00026494|E3|Reported Event|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267144|NCT00026494|E2|Reported Event|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267145|NCT00026494|E1|Reported Event|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
267146|NCT00010257|B3|Baseline|Total|Total of all reporting groups
267147|NCT00010257|B2|Baseline|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
267148|NCT00010257|B1|Baseline|Thymoma|Patients with diagnosis of thymoma
267149|NCT00010257|P2|Participant Flow|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
267150|NCT00010257|P1|Participant Flow|Thymoma|Patients with diagnosis of thymoma
267151|NCT00010257|O2|Outcome|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
267152|NCT00010257|O1|Outcome|Thymoma|Patients with diagnosis of thymoma
267153|NCT00010257|O2|Outcome|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
267154|NCT00010257|O1|Outcome|Thymoma|Patients with diagnosis of thymoma
267155|NCT00010257|E2|Reported Event|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
267156|NCT00010257|E1|Reported Event|Thymoma|Patients with diagnosis of thymoma
267157|NCT00010439|B1|Baseline|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
267158|NCT00010439|P1|Participant Flow|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
268194|NCT00042991|E5|Reported Event|Stratum IB at Dose 250 mg/m^2|Patients with STMG treated at 250 mg/m2
267160|NCT00010439|O1|Outcome|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
267161|NCT00010439|E1|Reported Event|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
267162|NCT00010803|B3|Baseline|Total|Total of all reporting groups
267163|NCT00010803|B2|Baseline|Placebo|Placebo 1 pill twice daily
267164|NCT00010803|B1|Baseline|Ginkgo Biloba|120 mg twice daily, total 240 mg
267165|NCT00010803|P2|Participant Flow|Placebo|Placebo twice daily
267166|NCT00010803|P1|Participant Flow|Ginkgo Biloba|EGb 761 Ginkgo biloba 120 mg twice daily
267167|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
267168|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
267169|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
267170|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
267171|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
267172|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
267173|NCT00010803|E2|Reported Event|Placebo|Placebo twice daily
267174|NCT00010803|E1|Reported Event|Ginkgo Biloba|EGb 761 Ginkgo biloba 120 mg twice daily
267175|NCT00017563|B1|Baseline|Docetaxel and Mitox|"Drug: docetaxel
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Drug: mitoxantrone hydrochloride
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
267176|NCT00017563|P1|Participant Flow|Docetaxel and Mitox|"Drug: docetaxel
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Drug: mitoxantrone hydrochloride
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
267177|NCT00017563|O1|Outcome|Docetaxel and Mitox|"Drug: docetaxel
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Drug: mitoxantrone hydrochloride
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
267178|NCT00017563|E1|Reported Event|Docetaxel and Mitox|"Drug: docetaxel
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Drug: mitoxantrone hydrochloride
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
267179|NCT00027027|B6|Baseline|Total|Total of all reporting groups
267180|NCT00027027|B5|Baseline|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267181|NCT00027027|B4|Baseline|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267182|NCT00027027|B3|Baseline|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267183|NCT00027027|B2|Baseline|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267184|NCT00027027|B1|Baseline|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267185|NCT00027027|P5|Participant Flow|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267186|NCT00027027|P4|Participant Flow|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267187|NCT00027027|P3|Participant Flow|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267188|NCT00027027|P2|Participant Flow|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267189|NCT00027027|P1|Participant Flow|rhuMAb 2C4: 0.5 Milligrams Per Kilogram (mg/kg)|Recombinant Humanized Antibody to human epidermal growth factor receptor 2 (rhuMAb 2C4) 0.5 mg/kg was administered once every 3 weeks as an intravenous (IV) infusion until progressive disease (PD) or unacceptable toxicity occurred for up to a maximum of 1 year.
267190|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267191|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267192|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267193|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267194|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267195|NCT00027027|O4|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267196|NCT00027027|O3|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267197|NCT00027027|O2|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
268195|NCT00042991|E4|Reported Event|Stratum IB at Dose 100 mg/m^2|Patients with STMG treated at 100 mg/m2
267198|NCT00027027|O1|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267199|NCT00027027|O4|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267200|NCT00027027|O3|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267201|NCT00027027|O2|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267202|NCT00027027|O1|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267203|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267204|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267205|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267206|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267207|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267208|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267209|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267210|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267211|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267212|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267213|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267214|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267215|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267216|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267217|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267218|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267219|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267220|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267221|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267222|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267223|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267224|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267225|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267226|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267227|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267228|NCT00027027|E5|Reported Event|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267229|NCT00027027|E4|Reported Event|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267230|NCT00027027|E3|Reported Event|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267231|NCT00027027|E2|Reported Event|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
267232|NCT00027027|E1|Reported Event|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
315913|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
267233|NCT00027560|B1|Baseline|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
267234|NCT00027560|P1|Participant Flow|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
267235|NCT00027560|O1|Outcome|Unrelated and Mismatched Related Patients|
267236|NCT00027560|O1|Outcome|Matched Related Patients|
267237|NCT00027560|O1|Outcome|Unrelated and Mismatched Related Patients|
267238|NCT00027560|O1|Outcome|Matched Related Patients|
267239|NCT00027560|O1|Outcome|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
267240|NCT00027560|O1|Outcome|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
267241|NCT00027560|E1|Reported Event|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
267242|NCT00027846|B4|Baseline|Total|Total of all reporting groups
267243|NCT00027846|B3|Baseline|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.
filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.
carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
267244|NCT00027846|B2|Baseline|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
267245|NCT00027846|B1|Baseline|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
267246|NCT00027846|P3|Participant Flow|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.
filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.
carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
267247|NCT00027846|P2|Participant Flow|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
267248|NCT00027846|P1|Participant Flow|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
267249|NCT00027846|O3|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.
filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.
carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
267250|NCT00027846|O2|Outcome|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
267251|NCT00027846|O1|Outcome|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
267252|NCT00027846|O2|Outcome|Anaplastic Ependymoma|Anaplastic ependymoma:tumor pathology by central review.
267253|NCT00027846|O1|Outcome|Differentiated Ependymoma|Differentiated ependymoma:tumor pathology by central review.
267254|NCT00027846|O2|Outcome|Anaplastic Ependymoma|Anaplastic ependymoma:tumor pathology by central review.
267255|NCT00027846|O1|Outcome|Differentiated Ependymoma|Differentiated ependymoma:tumor pathology by central review.
267270|NCT00028093|B2|Baseline|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
267301|NCT00029146|P1|Participant Flow|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267256|NCT00027846|O1|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.
filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.
carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
267257|NCT00027846|O3|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.
filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.
carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
267258|NCT00027846|O2|Outcome|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
267259|NCT00027846|O1|Outcome|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
267260|NCT00027846|O3|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.
filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.
carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
267261|NCT00027846|O2|Outcome|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
267262|NCT00027846|O1|Outcome|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
267263|NCT00027846|E2|Reported Event|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.
filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.
carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
267264|NCT00027846|E1|Reported Event|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
267265|NCT00028002|B1|Baseline|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
267266|NCT00028002|P1|Participant Flow|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
267267|NCT00028002|O1|Outcome|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
267268|NCT00028002|E1|Reported Event|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
267269|NCT00028093|B3|Baseline|Total|Total of all reporting groups
315914|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
267271|NCT00028093|B1|Baseline|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
267272|NCT00028093|P2|Participant Flow|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
267273|NCT00028093|P1|Participant Flow|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
267274|NCT00028093|O2|Outcome|Peginterferon|
267275|NCT00028093|O1|Outcome|Peginterferon+Ribavirin|
267276|NCT00028093|E2|Reported Event|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
267277|NCT00028093|E1|Reported Event|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
267278|NCT00028262|B1|Baseline|Drug Cystagon and N-acetylcysteine|
267279|NCT00028262|P1|Participant Flow|Drug Cystagon and N-acetylcysteine|
267280|NCT00028262|O1|Outcome|Drug Cystagon and N-acetylcysteine|
267281|NCT00028262|E1|Reported Event|Drug Cystagon and N-acetylcysteine|
267282|NCT00028769|B1|Baseline|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
267283|NCT00028769|P1|Participant Flow|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
267284|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
267285|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
267286|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
267287|NCT00028769|E1|Reported Event|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
267288|NCT00029107|B3|Baseline|Total|Total of all reporting groups
267289|NCT00029107|B2|Baseline|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
267290|NCT00029107|B1|Baseline|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
267291|NCT00029107|P2|Participant Flow|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
267292|NCT00029107|P1|Participant Flow|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
267293|NCT00029107|O2|Outcome|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
267294|NCT00029107|O1|Outcome|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
267295|NCT00029107|E2|Reported Event|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
267296|NCT00029107|E1|Reported Event|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
267297|NCT00029146|B3|Baseline|Total|Total of all reporting groups
267298|NCT00029146|B2|Baseline|Non-surgical Group|Receives best current practice medical therapy
267299|NCT00029146|B1|Baseline|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267300|NCT00029146|P2|Participant Flow|Non-surgical Group|Receives best current practice medical therapy
267302|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267303|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
267304|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267305|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
267306|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267307|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
267308|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267309|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
267310|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267311|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
267312|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267313|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
267314|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267315|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
267316|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267317|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
267318|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267319|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
267320|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267321|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
267322|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267323|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
267324|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267325|NCT00029146|E2|Reported Event|Non-surgical Group|Receives best current practice medical therapy
267326|NCT00029146|E1|Reported Event|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
267327|NCT00029172|B1|Baseline|Case Management|
267328|NCT00029172|P1|Participant Flow|Case Management|
267329|NCT00029172|O1|Outcome|Case Management|
267330|NCT00029172|E1|Reported Event|Case Management|
267331|NCT00029536|B5|Baseline|Total|Total of all reporting groups
267332|NCT00029536|B4|Baseline|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
267333|NCT00029536|B3|Baseline|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
267334|NCT00029536|B2|Baseline|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
267335|NCT00029536|B1|Baseline|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
267336|NCT00029536|P4|Participant Flow|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
267337|NCT00029536|P3|Participant Flow|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
267338|NCT00029536|P2|Participant Flow|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
267339|NCT00029536|P1|Participant Flow|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
267340|NCT00029536|O2|Outcome|Placebo Lozenges|Subjects with catamenial and non-Catamenial epilepsy who received matched placebo lozenges
267341|NCT00029536|O1|Outcome|Progesterone Lozenges|Subjects with catamenial and Non-Catamential epilepsy who received 200 mg progesterone lozenges
267342|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
267343|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
267344|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
267345|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
267346|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
267347|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
267348|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
267349|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
267350|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
267351|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
267352|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
268196|NCT00042991|E3|Reported Event|Stratum IA at Dose 375 mg/m^2|Brain Stem Glioma patients treated at 375 mg/m2
267353|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
267354|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
267355|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
267356|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
267357|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
267358|NCT00029536|E4|Reported Event|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
267359|NCT00029536|E3|Reported Event|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
267360|NCT00029536|E2|Reported Event|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
267361|NCT00029536|E1|Reported Event|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
267362|NCT00030147|B5|Baseline|Total|Total of all reporting groups
267363|NCT00030147|B4|Baseline|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
267364|NCT00030147|B3|Baseline|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
267365|NCT00030147|B2|Baseline|Placebo|Placebo skin patch and placebo tablets for eight weeks
267366|NCT00030147|B1|Baseline|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
267367|NCT00030147|P4|Participant Flow|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
267368|NCT00030147|P3|Participant Flow|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
267369|NCT00030147|P2|Participant Flow|Placebo|Placebo skin patch and placebo tablets for eight weeks
267370|NCT00030147|P1|Participant Flow|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
267371|NCT00030147|O4|Outcome|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
267372|NCT00030147|O3|Outcome|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
267373|NCT00030147|O2|Outcome|Placebo|Placebo skin patch and placebo tablets for eight weeks
267374|NCT00030147|O1|Outcome|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
267375|NCT00030147|O4|Outcome|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
267376|NCT00030147|O3|Outcome|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
267377|NCT00030147|O2|Outcome|Placebo|Placebo skin patch and placebo tablets for eight weeks
267378|NCT00030147|O1|Outcome|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
267379|NCT00030147|E4|Reported Event|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
267380|NCT00030147|E3|Reported Event|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
267381|NCT00030147|E2|Reported Event|Placebo|Placebo skin patch and placebo tablets for eight weeks
267382|NCT00030147|E1|Reported Event|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
267383|NCT00022490|B1|Baseline|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle
Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
267384|NCT00022490|P1|Participant Flow|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle
Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
267385|NCT00022490|O1|Outcome|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle
Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
267386|NCT00022490|E1|Reported Event|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle
Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
267387|NCT00022516|B3|Baseline|Total|Total of all reporting groups
267388|NCT00022516|B2|Baseline|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)
Cyclophosphamide: 50 mg/day orally continuously for 1 year
Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
267389|NCT00022516|B1|Baseline|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
267390|NCT00022516|P2|Participant Flow|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)
Cyclophosphamide: 50 mg/day orally continuously for 1 year
Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
267391|NCT00022516|P1|Participant Flow|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
267392|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)
Cyclophosphamide: 50 mg/day orally continuously for 1 year
Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
267393|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
267394|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)
Cyclophosphamide: 50 mg/day orally continuously for 1 year
Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
267395|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
267396|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)
Cyclophosphamide: 50 mg/day orally continuously for 1 year
Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
267397|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
267398|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)
Cyclophosphamide: 50 mg/day orally continuously for 1 year
Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
267399|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
267400|NCT00022516|E2|Reported Event|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)
Cyclophosphamide: 50 mg/day orally continuously for 1 year
Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
267401|NCT00022516|E1|Reported Event|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
267402|NCT00022633|B3|Baseline|Total|Total of all reporting groups
267403|NCT00022633|B2|Baseline|Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267404|NCT00022633|B1|Baseline|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267405|NCT00022633|P2|Participant Flow|Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267406|NCT00022633|P1|Participant Flow|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267407|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267408|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267409|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267410|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267411|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267412|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267413|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267414|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267415|NCT00022633|E1|Reported Event|Paclitaxel + Gemcitabine|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
267416|NCT00022659|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267417|NCT00022659|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267418|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267419|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267420|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267421|NCT00022659|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
267422|NCT00022672|B3|Baseline|Total|Total of all reporting groups
267423|NCT00022672|B2|Baseline|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267424|NCT00022672|B1|Baseline|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267425|NCT00022672|P2|Participant Flow|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
268197|NCT00042991|E2|Reported Event|Stratum IA at Dose 250 mg/m^2|Brain Stem Glioma patients treated at 250 mg/m2
267426|NCT00022672|P1|Participant Flow|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267427|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267428|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267429|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267430|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267431|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267432|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267433|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267434|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267435|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267436|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267437|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267438|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267439|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267440|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267441|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267442|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267443|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267444|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267445|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267446|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267447|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267448|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267449|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
268198|NCT00042991|E1|Reported Event|Stratum IA at Dose 100 mg/m^2|Brain Stem Glioma patients treated at 100 mg/m2
267450|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267451|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267452|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267453|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267454|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267455|NCT00022672|E3|Reported Event|Anastrozole (After Start of Trastuzumab)|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
267456|NCT00022672|E2|Reported Event|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase.
267457|NCT00022672|E1|Reported Event|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
267458|NCT00022698|B3|Baseline|Total|Total of all reporting groups
267459|NCT00022698|B2|Baseline|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267460|NCT00022698|B1|Baseline|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267461|NCT00022698|P2|Participant Flow|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267462|NCT00022698|P1|Participant Flow|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine (Xeloda) 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267463|NCT00022698|O3|Outcome|Total Participants (Cohort 1 + Cohort 2)|Total of all reporting groups.
267464|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267465|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267527|NCT00023322|B1|Baseline|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
267528|NCT00023322|P1|Participant Flow|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
267466|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267467|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267468|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267469|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267470|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267471|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267472|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267473|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267474|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267475|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267476|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267477|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267478|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267479|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267480|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267481|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen:(Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267482|NCT00022698|E2|Reported Event|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267483|NCT00022698|E1|Reported Event|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
267484|NCT00022763|B3|Baseline|Total|Total of all reporting groups
267485|NCT00022763|B2|Baseline|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267486|NCT00022763|B1|Baseline|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267529|NCT00023322|O1|Outcome|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
268199|NCT00043186|B10|Baseline|Total|Total of all reporting groups
267487|NCT00022763|P2|Participant Flow|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267488|NCT00022763|P1|Participant Flow|Stratum A|Participants of age greater than or equal to (>=) 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267489|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267490|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267491|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267492|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267493|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267494|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267495|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267496|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267497|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267498|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267499|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
268558|NCT00030901|P3|Participant Flow|Placebo|Patients receive oral placebo once daily for 3 years
267500|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267501|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267502|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267503|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267504|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267505|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267506|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267507|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267508|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
267509|NCT00022763|E1|Reported Event|Enfuvirtide|Participants in stratum A (age >= 3 years and less than 12 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose) and in stratum B (age >= 12 years and less than 17 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose).
267510|NCT00023309|B3|Baseline|Total|Total of all reporting groups
267511|NCT00023309|B2|Baseline|Adefovir|Patients to receive adefovir alone
267512|NCT00023309|B1|Baseline|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
267513|NCT00023309|P2|Participant Flow|Adefovir|Patients to receive adefovir alone (10 mg daily).
267514|NCT00023309|P1|Participant Flow|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir, with lamivudine of 100 mg daily and adefovir of 10 mg daily
267515|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
267516|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
267517|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
267518|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
267519|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
267520|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
267521|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
267522|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
267523|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
267524|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
267525|NCT00023309|E2|Reported Event|Adefovir|Patients to receive adefovir alone
267526|NCT00023309|E1|Reported Event|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
315915|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
267530|NCT00023322|O1|Outcome|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
267531|NCT00023322|E1|Reported Event|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
267532|NCT00023452|B3|Baseline|Total|Total of all reporting groups
267533|NCT00023452|B2|Baseline|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267534|NCT00023452|B1|Baseline|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267535|NCT00023452|P2|Participant Flow|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral rifapentine (RPT) tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by Directly Observed Therapy (DOT), defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267536|NCT00023452|P1|Participant Flow|9INH|Participants who were high-risk tuberculin skin test (TST) reactors (household and other close contacts of active tuberculosis [TB] cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on chest x-ray [CXR], human immunodeficiency virus [HIV] infected participants) self-administered oral isoniazid (INH) tablets (aged greater than or equal to [≥12] years of age received 5 milligrams per kilogram [mg/kg] and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267537|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267538|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267539|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267540|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267541|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267542|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267543|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267544|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267545|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267835|NCT00024167|E3|Reported Event|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
267546|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267547|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267548|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267549|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267550|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267551|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267552|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR], HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267553|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267554|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267555|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267556|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) daily for 9 months (240 to 270 total doses).
267557|NCT00023452|E2|Reported Event|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
267558|NCT00023452|E1|Reported Event|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
267559|NCT00023595|B6|Baseline|Total|Total of all reporting groups
267560|NCT00023595|B5|Baseline|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267561|NCT00023595|B4|Baseline|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267836|NCT00024167|E2|Reported Event|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
267562|NCT00023595|B3|Baseline|H01+H02: Medication + CABG|This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
267563|NCT00023595|B2|Baseline|H01: Medication + CABG|50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267564|NCT00023595|B1|Baseline|H01: Medication|50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267565|NCT00023595|P5|Participant Flow|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267566|NCT00023595|P4|Participant Flow|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267567|NCT00023595|P3|Participant Flow|H01+H02: Medication + CABG|This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
267568|NCT00023595|P2|Participant Flow|H01: Medication + CABG|50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267569|NCT00023595|P1|Participant Flow|H01: Medication|50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267570|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|"CABG plus Medication and Surgical ventricular reconstruction (SVR)
CABG plus MED and SVR: H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone"
267571|NCT00023595|O1|Outcome|H02: Medication+CABG|"Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease
CABG surgery plus MED: CABG plus standard medication management for Coronary Artery Disease"
267572|NCT00023595|O2|Outcome|H01: Medication|"Medical therapy alone to treat Coronary Artery Disease
Active Medication Alone: Standard medication for coronary artery disease and heart failure management."
267573|NCT00023595|O1|Outcome|H01: Medication + CABG|"Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease
CABG surgery plus MED (medication): CABG plus standard medication management for Coronary Artery Disease"
267574|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267575|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267576|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267577|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267578|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267579|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267580|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267581|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267582|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267837|NCT00024167|E1|Reported Event|Induction Treatment|Induction treatment option 1 or induction treatment option 2.
267583|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267584|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267585|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267586|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267587|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267588|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267589|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267590|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267591|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267592|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267593|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267594|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267595|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267596|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267597|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267598|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267599|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267600|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267601|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267602|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
268559|NCT00030901|P2|Participant Flow|Selenium|Patients receive oral selenium once daily for 3 years
267603|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267604|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267605|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267606|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267607|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267608|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267609|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267610|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267611|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267612|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267613|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267614|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267615|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267616|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267617|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267618|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267619|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267620|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267621|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267622|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
268560|NCT00030901|P1|Participant Flow|All Patients|
267623|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267624|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267625|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267626|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267627|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267628|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267629|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267630|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267631|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267632|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267633|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267634|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267635|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267636|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267637|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267638|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267639|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267640|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267641|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267642|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
268561|NCT00030901|O2|Outcome|Placebo|Patients receive oral placebo once daily for 3 years
267643|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267644|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267645|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267646|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267647|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267648|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267649|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267650|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267651|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267652|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267653|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267654|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267655|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267656|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267657|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267658|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267659|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267660|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267661|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267662|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
268562|NCT00030901|O1|Outcome|Selenium|Patients receive oral selenium once daily for 3 years
267663|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267664|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267665|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267666|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267667|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267668|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267669|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267670|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
267671|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
267672|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267673|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267674|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|
267675|NCT00023595|O1|Outcome|Total H02: Medication+CABG|
267676|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267677|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267678|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267679|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267680|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267681|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267682|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|
267683|NCT00023595|O1|Outcome|Total H02: Medication+CABG|
267684|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267685|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267686|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|
267687|NCT00023595|O1|Outcome|Total H02: Medication+CABG|
267688|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267689|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267690|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|
267691|NCT00023595|O1|Outcome|Total H02: Medication+CABG|
267692|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267693|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267694|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267695|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267696|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267697|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267698|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267699|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267700|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267701|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267702|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267703|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267704|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267705|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267706|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267707|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267708|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
268563|NCT00030901|O2|Outcome|Placebo|Patients receive oral placebo once daily for 3 years
267709|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267710|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267711|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267712|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267713|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267714|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267715|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267716|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267717|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267718|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267719|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267720|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267721|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267722|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267723|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267724|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267725|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267726|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267727|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267747|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267728|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267729|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267730|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267731|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267732|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267733|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267734|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267735|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267736|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267737|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267738|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267739|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267740|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267741|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267742|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267743|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267744|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267745|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267746|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267790|NCT00023712|B3|Baseline|Total|Total of all reporting groups
268109|NCT00042224|B2|Baseline|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine
Other Names:
• Clozaril"
267748|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267749|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267750|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267751|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267752|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267753|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267754|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267755|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267756|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267757|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267758|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267759|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267760|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267761|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267762|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267763|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267764|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267765|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267766|NCT00023595|O2|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267834|NCT00024167|O1|Outcome|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
267767|NCT00023595|O1|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
267768|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267769|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267770|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
267771|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
267772|NCT00023595|E5|Reported Event|H02: Medication+CABG+SVR|
267773|NCT00023595|E4|Reported Event|H02: Medication+CABG|
267774|NCT00023595|E3|Reported Event|H01 & H02: Medication+CABG|
267775|NCT00023595|E2|Reported Event|H01: Medication + CABG|
267776|NCT00023595|E1|Reported Event|H01: Medication|
267777|NCT00023673|B4|Baseline|Total|Total of all reporting groups
267778|NCT00023673|B3|Baseline|Phase II: 74 Gy/37 fx + Chemotherapy|Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
267779|NCT00023673|B2|Baseline|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
267780|NCT00023673|B1|Baseline|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
267781|NCT00023673|P4|Participant Flow|Phase II: 74 Gy/37 fx + Chemotherapy|Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
267782|NCT00023673|P3|Participant Flow|Phase I: 70 Gy/35 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 70 Gy given in 35 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
267783|NCT00023673|P2|Participant Flow|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
267784|NCT00023673|P1|Participant Flow|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
267785|NCT00023673|O1|Outcome|Phase I/II: 74 Gy/37 fx + Chemotherapy|"Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
carboplatin
paclitaxel
three-dimensional conformal radiation therapy"
267786|NCT00023673|O2|Outcome|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
267787|NCT00023673|O1|Outcome|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
267788|NCT00023673|E2|Reported Event|Phase I/II: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
267789|NCT00023673|E1|Reported Event|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
267791|NCT00023712|B2|Baseline|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267792|NCT00023712|B1|Baseline|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267793|NCT00023712|P2|Participant Flow|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267794|NCT00023712|P1|Participant Flow|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267795|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267796|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267797|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267798|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267799|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267800|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267801|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267802|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267803|NCT00023712|E2|Reported Event|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267804|NCT00023712|E1|Reported Event|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
267805|NCT00023764|B1|Baseline|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
267806|NCT00023764|P1|Participant Flow|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
267807|NCT00023764|O2|Outcome|PS-341 (Bortezomib)-Refractory Patients|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
267808|NCT00023764|O1|Outcome|PS-341 (Bortezomib)-Relapsed Patients|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
267809|NCT00023764|E1|Reported Event|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
267810|NCT00024102|B3|Baseline|Total|Total of all reporting groups
267811|NCT00024102|B2|Baseline|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
267812|NCT00024102|B1|Baseline|Standard Chemotherapy|"Patient/Physician choice of:
CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR
AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
267813|NCT00024102|P2|Participant Flow|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
267814|NCT00024102|P1|Participant Flow|Standard Chemotherapy|"Patient/Physician choice of:
CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles
OR
AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
267815|NCT00024102|O3|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles
267816|NCT00024102|O2|Outcome|Standard Chemotherapy (AC)|AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles
267817|NCT00024102|O1|Outcome|Standard Chemotherapy (CMF)|CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles
267818|NCT00024102|O2|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
267819|NCT00024102|O1|Outcome|Standard Chemotherapy|"Patient/Physician choice of:
CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR
AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
267820|NCT00024102|O2|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
267821|NCT00024102|O1|Outcome|Standard Chemotherapy|"Patient/Physician choice of:
CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR
AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
267822|NCT00024102|E3|Reported Event|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles
267823|NCT00024102|E2|Reported Event|Standard Chemotherapy (AC)|AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles
267824|NCT00024102|E1|Reported Event|Standard Chemotherapy (CMF)|CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles
267825|NCT00024167|B4|Baseline|Total|Total of all reporting groups
267826|NCT00024167|B3|Baseline|Induction Treatment + No Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
267827|NCT00024167|B2|Baseline|Induction Treatment + Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
267828|NCT00024167|B1|Baseline|Induction Treatment|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.
267829|NCT00024167|P2|Participant Flow|Induction Treatment + No Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
267830|NCT00024167|P1|Participant Flow|Induction Treatment + Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
267831|NCT00024167|O2|Outcome|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
267832|NCT00024167|O1|Outcome|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
267833|NCT00024167|O2|Outcome|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
268270|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
267838|NCT00036738|B1|Baseline|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description
Cyclosporine: Given IV or PO
Dasatinib: Given PO
Fludarabine Phosphate: Given IV
Imatinib Mesylate: Given PO
Mycophenolate Mofetil: Given PO
Nilotinib: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation
Therapeutic Allogeneic Lymphocytes: Given IV
Total-Body Irradiation: Undergo TBI"
267839|NCT00036738|P1|Participant Flow|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description
Cyclosporine: Given IV or PO
Dasatinib: Given PO
Fludarabine Phosphate: Given IV
Imatinib Mesylate: Given PO
Mycophenolate Mofetil: Given PO
Nilotinib: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation
Therapeutic Allogeneic Lymphocytes: Given IV
Total-Body Irradiation: Undergo TBI"
267840|NCT00036738|O1|Outcome|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description
Cyclosporine: Given IV or PO
Dasatinib: Given PO
Fludarabine Phosphate: Given IV
Imatinib Mesylate: Given PO
Mycophenolate Mofetil: Given PO
Nilotinib: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation
Therapeutic Allogeneic Lymphocytes: Given IV
Total-Body Irradiation: Undergo TBI"
267841|NCT00036738|O1|Outcome|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description
Cyclosporine: Given IV or PO
Dasatinib: Given PO
Fludarabine Phosphate: Given IV
Imatinib Mesylate: Given PO
Mycophenolate Mofetil: Given PO
Nilotinib: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation
Therapeutic Allogeneic Lymphocytes: Given IV
Total-Body Irradiation: Undergo TBI"
267842|NCT00036738|O1|Outcome|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description
Cyclosporine: Given IV or PO
Dasatinib: Given PO
Fludarabine Phosphate: Given IV
Imatinib Mesylate: Given PO
Mycophenolate Mofetil: Given PO
Nilotinib: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation
Therapeutic Allogeneic Lymphocytes: Given IV
Total-Body Irradiation: Undergo TBI"
267843|NCT00036738|E1|Reported Event|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description
Cyclosporine: Given IV or PO
Dasatinib: Given PO
Fludarabine Phosphate: Given IV
Imatinib Mesylate: Given PO
Mycophenolate Mofetil: Given PO
Nilotinib: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation
Therapeutic Allogeneic Lymphocytes: Given IV
Total-Body Irradiation: Undergo TBI"
267844|NCT00037830|B4|Baseline|Total|Total of all reporting groups
267845|NCT00037830|B3|Baseline|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
267846|NCT00037830|B2|Baseline|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
267847|NCT00037830|B1|Baseline|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
267848|NCT00037830|P3|Participant Flow|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
267849|NCT00037830|P2|Participant Flow|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
267850|NCT00037830|P1|Participant Flow|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
267851|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
267852|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
267853|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
267854|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
267855|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
267856|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
267857|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
267858|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
267859|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
267860|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
267861|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
267862|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
267863|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
267864|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
267865|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
267866|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
268564|NCT00030901|O1|Outcome|Selenium|Patients receive oral selenium once daily for 3 years
267867|NCT00037830|E3|Reported Event|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
267868|NCT00037830|E2|Reported Event|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
267869|NCT00037830|E1|Reported Event|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
267870|NCT00038103|B3|Baseline|Total|Total of all reporting groups
267871|NCT00038103|B2|Baseline|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
267872|NCT00038103|B1|Baseline|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
267873|NCT00038103|P2|Participant Flow|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
267874|NCT00038103|P1|Participant Flow|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
267875|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
267876|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
267877|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
267878|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
267879|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
267880|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
267881|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
267882|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
267883|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
267884|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
267885|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
267886|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
267887|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
267888|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
267889|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
267890|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
267891|NCT00038103|E2|Reported Event|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
267892|NCT00038103|E1|Reported Event|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
267893|NCT00038467|B3|Baseline|Total|Total of all reporting groups
267894|NCT00038467|B2|Baseline|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267895|NCT00038467|B1|Baseline|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267896|NCT00038467|P2|Participant Flow|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267897|NCT00038467|P1|Participant Flow|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267898|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267899|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267900|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267901|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
268565|NCT00030901|E2|Reported Event|Placebo|Patients receive oral placebo once daily for 3 years
267902|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267903|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267904|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267905|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267906|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267907|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267908|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267909|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267910|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267911|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267912|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267913|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267914|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267915|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267916|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267917|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267918|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267919|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267920|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267921|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
268306|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
267922|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267923|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267924|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267925|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267926|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267927|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267928|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267929|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267930|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267931|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267932|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267933|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267934|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267935|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267936|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267937|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267938|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267939|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267940|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267941|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
268342|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
267942|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267943|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267944|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267945|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267946|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267947|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267948|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267949|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267950|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267951|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267952|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267953|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267954|NCT00038467|E2|Reported Event|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
267955|NCT00038467|E1|Reported Event|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
267956|NCT00038610|B1|Baseline|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
267957|NCT00038610|P1|Participant Flow|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
267994|NCT00021541|P2|Participant Flow|Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I.Patients receive placebo ONLY in the first treatment until they progress to the second treatment/crossover to receive tipifarnib.
267995|NCT00021541|P1|Participant Flow|Tipifarnib (R11577)|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.Patients receive tipifarnib ONLY in the first treatment until they progress to the second treatment/crossover to receive placebo.
268566|NCT00030901|E1|Reported Event|Selenium|Patients receive oral selenium once daily for 3 years
267958|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
267959|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
267960|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
267961|NCT00038610|E1|Reported Event|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
267962|NCT00038857|B1|Baseline|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
267963|NCT00038857|P1|Participant Flow|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
267964|NCT00038857|O1|Outcome|Melphalan + Thiotepa + Fludarabine + Rabbit ATG + CD34 PBPC|Melphalan 140 mg/m^2 given for one day. Thiotepa 10 mg/kg given for one day. Fludarabine 40 mg/m^2 given daily for four days. Rabbit ATG 1.5 mg/kg given daily for four days. Infusion of CD34+ Selected Cells given on Day 0.
267965|NCT00038857|E1|Reported Event|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
267966|NCT00038948|B3|Baseline|Total|Total of all reporting groups
267967|NCT00038948|B2|Baseline|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
267968|NCT00038948|B1|Baseline|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
267969|NCT00038948|P2|Participant Flow|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
267970|NCT00038948|P1|Participant Flow|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
267971|NCT00038948|O4|Outcome|CNI Continuation Strata >40.0 mL/Min|Continued calcineurin inhibitor therapy
267972|NCT00038948|O3|Outcome|SRL Conversion Strata >40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
267973|NCT00038948|O2|Outcome|CNI Continuation Strata 20.0-40.0 mL/Min|Continued calcineurin inhibitor therapy
267974|NCT00038948|O1|Outcome|SRL Conversion Strata 20.0-40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
267975|NCT00038948|O4|Outcome|CNI Continuation Strata >40.0 mL/Min|Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
267976|NCT00038948|O3|Outcome|SRL Conversion Strata >40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in renal transplant recipients.
267977|NCT00038948|O2|Outcome|CNI Continuation Strata 20.0-40.0 mL/Min|Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
267978|NCT00038948|O1|Outcome|SRL Conversion Strata 20.0-40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in stable renal transplant recipients
267979|NCT00038948|E2|Reported Event|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
267980|NCT00038948|E1|Reported Event|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
267996|NCT00021541|O1|Outcome|Tipifarnib & Placebo|"Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I."
267997|NCT00021541|O2|Outcome|Phase B|Placebo/Tipifarnib
267998|NCT00021541|O1|Outcome|Phase A|Tipifarnib/placebo
267981|NCT00039130|B1|Baseline|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)
Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
267982|NCT00039130|P1|Participant Flow|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)
Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
267983|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)
Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
267984|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)
Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
267985|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)
Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
267986|NCT00039130|E1|Reported Event|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)
Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)
Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
267987|NCT00039195|B1|Baseline|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
267988|NCT00039195|P1|Participant Flow|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
267989|NCT00039195|O1|Outcome|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
267990|NCT00039195|E1|Reported Event|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
267991|NCT00021541|B3|Baseline|Total|Total of all reporting groups
267992|NCT00021541|B2|Baseline|Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I. These are the patients that started on placebo only. This number does not reflect the total amount of patients that crossed over to tipifarnib. Two of the 31 patients were deemed ineligible, thus 29 started placebo.
267993|NCT00021541|B1|Baseline|R115777 (Tipifarnib)|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. These are the patients that started on tipifarnib only. This number does not reflect the total amount of patients that crossed over to placebo.
268088|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
267999|NCT00021541|E1|Reported Event|Tipifarnib & Placebo|"Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I."
268000|NCT00027378|B3|Baseline|Total|Total of all reporting groups
268001|NCT00027378|B2|Baseline|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
268002|NCT00027378|B1|Baseline|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
268003|NCT00027378|P2|Participant Flow|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
268004|NCT00027378|P1|Participant Flow|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
268005|NCT00027378|O2|Outcome|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
268006|NCT00027378|O1|Outcome|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
268007|NCT00027378|O2|Outcome|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
268008|NCT00027378|O1|Outcome|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
268009|NCT00027378|E2|Reported Event|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
268010|NCT00027378|E1|Reported Event|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
268011|NCT00039377|B1|Baseline|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
268012|NCT00039377|P4|Participant Flow|Patients Who Did Not Undergo Transplant for Course V|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
268013|NCT00039377|P3|Participant Flow|Patients Without HLA-matched Sibling Donors in Course V|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
268014|NCT00039377|P2|Participant Flow|Patients With HLA-matched Sibling Donor in Course 5|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
268015|NCT00039377|P1|Participant Flow|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
268016|NCT00039377|O2|Outcome|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
268017|NCT00039377|O1|Outcome|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
268089|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
268090|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
268091|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
268018|NCT00039377|O2|Outcome|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
268019|NCT00039377|O1|Outcome|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
268020|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
268021|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
268022|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
268023|NCT00039377|E3|Reported Event|Patients Who Did Not Undergo Transplant|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
268024|NCT00039377|E2|Reported Event|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
268025|NCT00039377|E1|Reported Event|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
268026|NCT00041392|B3|Baseline|Total|Total of all reporting groups
268027|NCT00041392|B2|Baseline|0.9 % Saline|100 mg/kg 0.9 % saline
268028|NCT00041392|B1|Baseline|Magnesium|100 mg/kg magnesium
268029|NCT00041392|P2|Participant Flow|0.9 % Saline|100 mg/kg 0.9 % saline
268030|NCT00041392|P1|Participant Flow|Magnesium|100 mg/kg magnesium
268031|NCT00041392|O2|Outcome|0.9 % Saline|100 mg/kg 0.9 % saline
268032|NCT00041392|O1|Outcome|Magnesium|100 mg/kg magnesium
268033|NCT00041392|E2|Reported Event|0.9 % Saline|100 mg/kg 0.9 % saline
268034|NCT00041392|E1|Reported Event|Magnesium|100 mg/kg magnesium
268035|NCT00041470|B1|Baseline|Phase I/II|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, toxicity or other reason to remove the patient from protocol treatment.
Paclitaxel is administered weekly. Dose levels:
50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2
Vinorelbine (Navelbine) is administered one hour after paclitaxel, every week. Dose levels:
20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2
Patients whose tumors over express HER-2-neu and who meet the cardiac safety criteria will receive weekly Herceptin administered by intravenous infusion.
Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.
G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.
Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease pr"
268036|NCT00041470|P1|Participant Flow|Paclitaxel, Vinorelbine, G-CSF, Herceptin - no Placebo|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, toxicity or other reason to remove the patient from protocol treatment.
Paclitaxel is administered weekly. Dose levels:
50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2
Vinorelbine (Navelbine) is administered one hour after paclitaxel, every week. Dose levels:
20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2
Patients whose tumors over express HER-2-neu and who meet the cardiac safety criteria will receive weekly Herceptin administered by intravenous infusion.
Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.
G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.
Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until progression"
268092|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
268093|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
268094|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
268095|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
268096|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
268037|NCT00041470|O1|Outcome|Weekly Paclitaxel, Vinorelbine and GCSF|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease.
Paclitaxel weekly. Dose levels:
50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2
Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels:
20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2
Patients who are HER-2+ and IV infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.
G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., administered daily
Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Vinorelbine: 20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Herceptin: 4 mg/kg IV loading dose day 1"
268038|NCT00041470|O1|Outcome|Weekly Paclitaxel, Vinorelbine and GCSF|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease.
Paclitaxel weekly. Dose levels:
50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2
Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels:
20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2
Patients who are HER-2+ and IV infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.
G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., administered daily
Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Vinorelbine: 20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Herceptin: 4 mg/kg IV loading dose day 1"
268039|NCT00041470|E1|Reported Event|Weekly Paclitaxel and Vinorelbine With GCSF Support|"Weekly paclitaxel (50 mg/m2 IV) and vinorelbine (20 mg/m2 IV) with daily G-CSF and Herceptin for patients with HER-2+ disease. Treatment until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Paclitaxel administered weekly. Dose levels:
50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2
Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels:
20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2
Patients who are HER-2+ and meet the cardiac safety criteria will receive weekly Herceptin administered by infusion.
Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.
G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.
Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease pr"
268040|NCT00041717|B3|Baseline|Total|Total of all reporting groups
268041|NCT00041717|B2|Baseline|Placebo|Placebo : Placebo
268042|NCT00041717|B1|Baseline|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
268043|NCT00041717|P2|Participant Flow|Placebo|Placebo : Placebo
268044|NCT00041717|P1|Participant Flow|Fampridine-SR 50mg/Day|Fampridine-sustained release (SR) : 25mg bid (twice daily)
268045|NCT00041717|O2|Outcome|Placebo|Placebo : Placebo
268046|NCT00041717|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
268047|NCT00041717|O2|Outcome|Placebo|Placebo : Placebo
268048|NCT00041717|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
268049|NCT00041717|E2|Reported Event|Placebo|Placebo : Placebo
268050|NCT00041717|E1|Reported Event|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
268051|NCT00041756|B6|Baseline|Total|Total of all reporting groups
268052|NCT00041756|B5|Baseline|200 mg PG-530742|200 mg PG-530742 dosed BID
268053|NCT00041756|B4|Baseline|100 mg PG-530742|100 mg PG-530742 dosed BID
268054|NCT00041756|B3|Baseline|50 mg PG-530742|50 mg PG-530742 dosed BID
268055|NCT00041756|B2|Baseline|25 mg PG-530742|25 mg PG-530742 dosed BID
268056|NCT00041756|B1|Baseline|Placebo Tablet|Placebo tablet dosed BID
268057|NCT00041756|P5|Participant Flow|200 mg PG-530742|200 mg PG-530742 dosed BID
268058|NCT00041756|P4|Participant Flow|100 mg PG-530742|100 mg PG-530742 dosed BID
268059|NCT00041756|P3|Participant Flow|50 mg PG-530742|50 mg PG-530742 dosed BID
268060|NCT00041756|P2|Participant Flow|25 mg PG-530742|25 mg PG-530742 dosed BID
268061|NCT00041756|P1|Participant Flow|Placebo Tablet|Placebo tablet dosed BID
268062|NCT00041756|O5|Outcome|200 mg PG-530742|200 mg PG-530742 dosed BID
268063|NCT00041756|O4|Outcome|100 mg PG-530742|100 mg PG-530742 dosed BID
268064|NCT00041756|O3|Outcome|50 mg PG-530742|50 mg PG-530742 dosed BID
268065|NCT00041756|O2|Outcome|25 mg PG-530742|25 mg PG-530742 dosed BID
268066|NCT00041756|O1|Outcome|Placebo Tablet|Placebo tablet dosed BID
268067|NCT00041756|O5|Outcome|200 mg PG-530742|200 mg PG-530742 dosed BID
268068|NCT00041756|O4|Outcome|100 mg PG-530742|100 mg PG-530742 dosed BID
268069|NCT00041756|O3|Outcome|50 mg PG-530742|50 mg PG-530742 dosed BID
268070|NCT00041756|O2|Outcome|25 mg PG-530742|25 mg PG-530742 dosed BID
268071|NCT00041756|O1|Outcome|Placebo Tablet|Placebo tablet dosed BID
268072|NCT00041756|E5|Reported Event|200 mg PG-530742|200 mg PG-530742 dosed BID
268073|NCT00041756|E4|Reported Event|100 mg PG-530742|100 mg PG-530742 dosed BID
268074|NCT00041756|E3|Reported Event|50 mg PG-530742|50 mg PG-530742 dosed BID
268075|NCT00041756|E2|Reported Event|25 mg PG-530742|25 mg PG-530742 dosed BID
268076|NCT00041756|E1|Reported Event|Placebo Tablet|Placebo tablet dosed BID
268077|NCT00041938|B3|Baseline|Total|Total of all reporting groups
268078|NCT00041938|B2|Baseline|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
268079|NCT00041938|B1|Baseline|Aspirin|Aspirin : 325 mg per day
268080|NCT00041938|P2|Participant Flow|Warfarin|Warfarin : International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
268081|NCT00041938|P1|Participant Flow|Aspirin|Aspirin : 325 mg per day
268082|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
268083|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
268084|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
268085|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
268086|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
268087|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
268110|NCT00042224|B1|Baseline|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
Drug: Clozapine Patients with psychotic symptoms will receive clozapine
Other Names:
• Clozaril"
268111|NCT00042224|P2|Participant Flow|2 Medication Monotherapy|Clozapine: Patients with psychotic symptoms will receive clozapine
268112|NCT00042224|P1|Participant Flow|1 Electroconvulsive Therapy With Medication|"Electroconvulsive Therapy (ECT): ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
Clozapine: Patients with psychotic symptoms will receive clozapine"
268113|NCT00042224|O2|Outcome|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine
Other Names:
• Clozaril"
268114|NCT00042224|O1|Outcome|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
Drug: Clozapine Patients with psychotic symptoms will receive clozapine
Other Names:
• Clozaril"
268115|NCT00042224|E2|Reported Event|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine
Other Names:
• Clozaril"
268116|NCT00042224|E1|Reported Event|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
Drug: Clozapine Patients with psychotic symptoms will receive clozapine
Other Names:
• Clozaril"
268117|NCT00042432|B3|Baseline|Total|Total of all reporting groups
268118|NCT00042432|B2|Baseline|Placebo|Placebo administered orally once daily
268119|NCT00042432|B1|Baseline|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
268120|NCT00042432|P2|Participant Flow|Placebo|Placebo administered orally once daily
268121|NCT00042432|P1|Participant Flow|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
268122|NCT00042432|O2|Outcome|Placebo|Placebo administered orally once daily
268123|NCT00042432|O1|Outcome|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
268124|NCT00042432|O2|Outcome|Placebo|Placebo administered orally once daily
268125|NCT00042432|O1|Outcome|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
268126|NCT00042432|E2|Reported Event|Cinacalcet|
268127|NCT00042432|E1|Reported Event|Placebo|
268128|NCT00042939|B3|Baseline|Total|Total of all reporting groups
268129|NCT00042939|B2|Baseline|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.
On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
268130|NCT00042939|B1|Baseline|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
268131|NCT00042939|P2|Participant Flow|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.
On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
268132|NCT00042939|P1|Participant Flow|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
268133|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.
On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
268378|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268134|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
268135|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.
On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
268136|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
268137|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.
On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
268138|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
268139|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.
On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
268140|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
268141|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.
On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
268142|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
268164|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
268165|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
268191|NCT00042991|O1|Outcome|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 100 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
268143|NCT00042939|E2|Reported Event|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.
On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
268144|NCT00042939|E1|Reported Event|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².
Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
268145|NCT00042991|B8|Baseline|Total|Total of all reporting groups
268146|NCT00042991|B7|Baseline|Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268147|NCT00042991|B6|Baseline|Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268148|NCT00042991|B5|Baseline|Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268149|NCT00042991|B4|Baseline|Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268150|NCT00042991|B3|Baseline|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268151|NCT00042991|B2|Baseline|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268152|NCT00042991|B1|Baseline|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268153|NCT00042991|P7|Participant Flow|Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268154|NCT00042991|P6|Participant Flow|Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268155|NCT00042991|P5|Participant Flow|Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268156|NCT00042991|P4|Participant Flow|Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268157|NCT00042991|P3|Participant Flow|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268158|NCT00042991|P2|Participant Flow|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268159|NCT00042991|P1|Participant Flow|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
268160|NCT00042991|O1|Outcome|Stratum IB and Stratum II|Activation and mutations of EGFR have been associated with many cancers. In this secondary objective, we identify how many patients have activated EGFR and this requires a tumor sample from patients, which is only available from supratentorial malignant glioma patients treated on Stratum IB and Stratum II.
268161|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
268162|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
268163|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
268628|NCT00031486|E1|Reported Event|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
268166|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
268167|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
268168|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
268169|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
268170|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
268171|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
268172|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
268173|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
268174|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
268175|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
268176|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
268177|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
268178|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
268179|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
268180|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
268181|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
268182|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
268183|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
268184|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
268185|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
268186|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
268187|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
268188|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
268189|NCT00042991|O3|Outcome|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 375 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
268190|NCT00042991|O2|Outcome|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 250 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
268192|NCT00042991|E7|Reported Event|Stratum II at Dose 100 mg/m^2|Patients with STMG treated at 100 mg/m2 who are receiving EIACD
268200|NCT00043186|B9|Baseline|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268201|NCT00043186|B8|Baseline|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268202|NCT00043186|B7|Baseline|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268203|NCT00043186|B6|Baseline|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268204|NCT00043186|B5|Baseline|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268205|NCT00043186|B4|Baseline|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268206|NCT00043186|B3|Baseline|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268207|NCT00043186|B2|Baseline|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268208|NCT00043186|B1|Baseline|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268209|NCT00043186|P9|Participant Flow|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268210|NCT00043186|P8|Participant Flow|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268211|NCT00043186|P7|Participant Flow|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268212|NCT00043186|P6|Participant Flow|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268213|NCT00043186|P5|Participant Flow|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268214|NCT00043186|P4|Participant Flow|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268215|NCT00043186|P3|Participant Flow|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268216|NCT00043186|P2|Participant Flow|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268217|NCT00043186|P1|Participant Flow|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268218|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268219|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268220|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268221|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268222|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268223|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268224|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268225|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268226|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268227|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268228|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268229|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268230|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268231|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268232|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268233|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268234|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268629|NCT00031551|B3|Baseline|Total|Total of all reporting groups
268235|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268236|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268237|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268238|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268239|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268240|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268241|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268242|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268243|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268244|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268245|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268246|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268247|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268248|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268249|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268250|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268251|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268252|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268253|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268254|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268255|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268256|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268257|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268258|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268259|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268260|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268261|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268262|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268263|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268264|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268265|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268266|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268267|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268268|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268269|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268519|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268271|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268272|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268273|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268274|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268275|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268276|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268277|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268278|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268279|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268280|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268281|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268282|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268283|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268284|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268285|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268286|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268287|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268288|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268289|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268290|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268291|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268292|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268293|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268294|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268295|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268296|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268297|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268298|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268299|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268300|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268301|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268302|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268303|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268304|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268305|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
269040|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
268307|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268308|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268309|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268310|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268311|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268312|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268313|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268314|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268315|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268316|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268317|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268318|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268319|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268320|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268321|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268322|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268323|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268324|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268325|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268326|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268327|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268328|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268329|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268330|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268331|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268332|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268333|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268334|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268335|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268336|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268337|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268338|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268339|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268340|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268341|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
269041|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
268343|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268344|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268345|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268346|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268347|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268348|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268349|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268350|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268351|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268352|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268353|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268354|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268355|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268356|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268357|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268358|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268359|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268360|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268361|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268362|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268363|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268364|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268365|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268366|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268367|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268368|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268369|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268370|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268371|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268372|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268373|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268374|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268375|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268376|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268377|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
269042|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
268379|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268380|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268381|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268382|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268383|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268384|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268385|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268386|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268387|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268388|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268389|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268390|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268391|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268392|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268393|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268394|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268395|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268396|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268397|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268398|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268399|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268400|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268401|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268402|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268403|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268404|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268405|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268406|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268407|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268408|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268409|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268410|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268411|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268412|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268413|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
269043|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
268414|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268415|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268416|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268417|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268418|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268419|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268420|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268421|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268422|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268423|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268424|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268425|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268426|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268427|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268428|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268429|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268430|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268431|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268432|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268433|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268434|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268435|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268436|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268437|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268438|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268439|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268440|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268441|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268442|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268443|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268444|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268445|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268446|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268447|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268448|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
269044|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
268449|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268450|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268451|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268452|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268453|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268454|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268455|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268456|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268457|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268458|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268459|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268460|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268461|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268462|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268463|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268464|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268465|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268466|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268467|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268468|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268469|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268470|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268471|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268472|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268473|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268474|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268475|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268476|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268477|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268478|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268479|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268480|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268481|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268482|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268483|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268520|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268484|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268485|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268486|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268487|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268488|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268489|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268490|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268491|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268492|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268493|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268494|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268495|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268496|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268497|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268498|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268499|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268500|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268501|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268502|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268503|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268504|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268505|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268506|NCT00043186|O1|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268507|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268508|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268509|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268510|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268511|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268512|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268513|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268514|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268515|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268516|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268517|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268518|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268521|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268522|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268523|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268524|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268525|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268526|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268527|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268528|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268529|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268530|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268531|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268532|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268533|NCT00043186|E9|Reported Event|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
268534|NCT00043186|E8|Reported Event|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
268535|NCT00043186|E7|Reported Event|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268536|NCT00043186|E6|Reported Event|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
268537|NCT00043186|E5|Reported Event|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268538|NCT00043186|E4|Reported Event|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
268539|NCT00043186|E3|Reported Event|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268540|NCT00043186|E2|Reported Event|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
268541|NCT00043186|E1|Reported Event|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
268542|NCT00043550|B4|Baseline|Total|Total of all reporting groups
268543|NCT00043550|B3|Baseline|3 Pill Placebo|"Participants receive placebo.
Pill Placebo : Participants will receive a pill placebo."
268544|NCT00043550|B2|Baseline|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.
Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
268545|NCT00043550|B1|Baseline|1 Sertraline|"Participants receive sertraline.
Sertraline : Participants will receive sertraline."
268546|NCT00043550|P3|Participant Flow|3 Pill Placebo|"Participants receive placebo.
Pill Placebo : Participants will receive a pill placebo."
268547|NCT00043550|P2|Participant Flow|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.
Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
268548|NCT00043550|P1|Participant Flow|1 Sertraline|"Participants receive sertraline.
Sertraline : Participants will receive sertraline."
268549|NCT00043550|O3|Outcome|3 Pill Placebo|"Participants receive placebo.
Pill Placebo : Participants will receive a pill placebo."
268550|NCT00043550|O2|Outcome|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.
Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
268551|NCT00043550|O1|Outcome|1 Sertraline|"Participants receive sertraline.
Sertraline : Participants will receive sertraline."
268552|NCT00043550|E3|Reported Event|3 Pill Placebo|"Participants receive placebo.
Pill Placebo : Participants will receive a pill placebo."
268553|NCT00043550|E2|Reported Event|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.
Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
268554|NCT00043550|E1|Reported Event|1 Sertraline|"Participants receive sertraline.
Sertraline : Participants will receive sertraline."
268555|NCT00030901|B3|Baseline|Total|Total of all reporting groups
268556|NCT00030901|B2|Baseline|Placebo|Patients receive oral placebo once daily for 3 years
268557|NCT00030901|B1|Baseline|Selenium|Patients receive oral selenium once daily for 3 years
268567|NCT00030992|B1|Baseline|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
268568|NCT00030992|P1|Participant Flow|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
268569|NCT00030992|O1|Outcome|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
268570|NCT00030992|O1|Outcome|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
268571|NCT00030992|E1|Reported Event|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
268572|NCT00031447|B3|Baseline|Total|Total of all reporting groups
268573|NCT00031447|B2|Baseline|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268574|NCT00031447|B1|Baseline|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
268575|NCT00031447|P2|Participant Flow|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268576|NCT00031447|P1|Participant Flow|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
268577|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268578|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
268579|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268580|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
268581|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268582|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
268583|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268584|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
268585|NCT00031447|E2|Reported Event|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268586|NCT00031447|E1|Reported Event|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
268587|NCT00031460|B3|Baseline|Total|Total of all reporting groups
268588|NCT00031460|B2|Baseline|Placebo|Identical volume as acyclovir.
268589|NCT00031460|B1|Baseline|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268590|NCT00031460|P2|Participant Flow|Placebo|Identical volume as acyclovir.
268591|NCT00031460|P1|Participant Flow|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268592|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
268593|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268594|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
268595|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268596|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
268597|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268598|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
268599|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268600|NCT00031460|E2|Reported Event|Placebo|Identical volume as acyclovir.
268601|NCT00031460|E1|Reported Event|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
268602|NCT00031486|B3|Baseline|Total|Total of all reporting groups
268603|NCT00031486|B2|Baseline|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
268604|NCT00031486|B1|Baseline|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
268605|NCT00031486|P2|Participant Flow|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
268606|NCT00031486|P1|Participant Flow|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
268607|NCT00031486|O3|Outcome|Total|
268608|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
268609|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
268610|NCT00031486|O3|Outcome|Total|
268611|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
268612|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
268613|NCT00031486|O3|Outcome|Total|
268614|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
268615|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
268616|NCT00031486|O3|Outcome|Total|
268617|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
268618|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
268619|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
268620|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
268621|NCT00031486|O3|Outcome|Total|
268622|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
268623|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
268624|NCT00031486|O3|Outcome|Total|
268625|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
268626|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
268627|NCT00031486|E2|Reported Event|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
268630|NCT00031551|B2|Baseline|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
268631|NCT00031551|B1|Baseline|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.
Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
268632|NCT00031551|P2|Participant Flow|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
268633|NCT00031551|P1|Participant Flow|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.
Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
268634|NCT00031551|O1|Outcome|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
268635|NCT00031551|O2|Outcome|Pilot Study: Day 9 After CT Scores|
268636|NCT00031551|O1|Outcome|Pilot Study: Baseline Scores|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
268637|NCT00031551|O1|Outcome|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.
Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
268638|NCT00031551|O2|Outcome|Main Study: Placebo Mouthwash|"Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.
Placebo"
268639|NCT00031551|O1|Outcome|Main Study: Etanercept Mouthwash|"Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
Etanercept"
268640|NCT00031551|E2|Reported Event|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
268641|NCT00031551|E1|Reported Event|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.
Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
268642|NCT00031694|B1|Baseline|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies"
268643|NCT00031694|P1|Participant Flow|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies"
268644|NCT00031694|O1|Outcome|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies"
268645|NCT00031694|E1|Reported Event|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies"
268646|NCT00032487|B3|Baseline|Total|Total of all reporting groups
268647|NCT00032487|B2|Baseline|Arm 2/Intensive Glycemic Control|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Standard glycemic control
268648|NCT00032487|B1|Baseline|Arm 1/Standard Glycemic Control|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
268649|NCT00032487|P2|Participant Flow|Intensive Glycemic Control|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
269045|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
268650|NCT00032487|P1|Participant Flow|Standard Glycemic Control|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
268651|NCT00032487|O2|Outcome|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
268652|NCT00032487|O1|Outcome|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
268653|NCT00032487|O2|Outcome|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
268654|NCT00032487|O1|Outcome|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
268655|NCT00032487|E2|Reported Event|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
268656|NCT00032487|E1|Reported Event|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
268657|NCT00032591|B3|Baseline|Total|Total of all reporting groups
268658|NCT00032591|B2|Baseline|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
268659|NCT00032591|B1|Baseline|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
268660|NCT00032591|P2|Participant Flow|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
268661|NCT00032591|P1|Participant Flow|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
268662|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
268663|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
268664|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
268665|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
268666|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
268667|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
268668|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
268669|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
268670|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
268671|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
268672|NCT00032591|E2|Reported Event|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
268673|NCT00032591|E1|Reported Event|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
268674|NCT00032630|B3|Baseline|Total|Total of all reporting groups
268675|NCT00032630|B2|Baseline|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
268676|NCT00032630|B1|Baseline|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
268677|NCT00032630|P2|Participant Flow|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
268678|NCT00032630|P1|Participant Flow|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
268679|NCT00032630|O2|Outcome|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
268680|NCT00032630|O1|Outcome|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
268681|NCT00032630|O2|Outcome|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
268682|NCT00032630|O1|Outcome|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
268683|NCT00032630|E2|Reported Event|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
268684|NCT00032630|E1|Reported Event|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
268685|NCT00033293|B3|Baseline|Total|Total of all reporting groups
268686|NCT00033293|B2|Baseline|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
268730|NCT00033540|O1|Outcome|Gemcitabine and Capecitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
268731|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
269046|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
268687|NCT00033293|B1|Baseline|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
268688|NCT00033293|P2|Participant Flow|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
268689|NCT00033293|P1|Participant Flow|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
268690|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
268691|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
268692|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
268693|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
268694|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
268695|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
268696|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
268697|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
268698|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
268699|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
268700|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
268701|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
268702|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
268703|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
268704|NCT00033293|E2|Reported Event|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
268732|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
268733|NCT00033540|E1|Reported Event|Gemcitabine and Capecitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
268705|NCT00033293|E1|Reported Event|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.
Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
268706|NCT00033371|B3|Baseline|Total|Total of all reporting groups
268707|NCT00033371|B2|Baseline|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
268708|NCT00033371|B1|Baseline|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
268709|NCT00033371|P2|Participant Flow|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
268710|NCT00033371|P1|Participant Flow|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
268711|NCT00033371|O2|Outcome|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
268712|NCT00033371|O1|Outcome|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
268713|NCT00033371|E2|Reported Event|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
268714|NCT00033371|E1|Reported Event|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
268715|NCT00033514|B3|Baseline|Total|Total of all reporting groups
268716|NCT00033514|B2|Baseline|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.
erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
268717|NCT00033514|B1|Baseline|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.
erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
268718|NCT00033514|P2|Participant Flow|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.
erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
268719|NCT00033514|P1|Participant Flow|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.
erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
268720|NCT00033514|O1|Outcome|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.
erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
268721|NCT00033514|O1|Outcome|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.
erlotinib hydrochloride:150 mg daily."
268722|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.
erlotinib hydrochloride: 50mg daily, 100 mg daily and 150 mg daily."
268723|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.
erlotinib hydrochloride: 150 mg daily."
268724|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.
erlotinib hydrochloride: 150 mg daily."
268725|NCT00033514|E1|Reported Event|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.
erlotinib hydrochloride: 50mg daily, 100 mg daily and 150 mg daily."
268726|NCT00033540|B1|Baseline|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
268727|NCT00033540|P1|Participant Flow|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
268728|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
268729|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
268734|NCT00033631|B3|Baseline|Total|Total of all reporting groups
315916|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
268735|NCT00033631|B2|Baseline|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
268736|NCT00033631|B1|Baseline|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
268737|NCT00033631|P2|Participant Flow|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
268738|NCT00033631|P1|Participant Flow|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
268739|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
268740|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
268741|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
268742|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
268743|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
268744|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
268745|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
268746|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
268747|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
268748|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
268749|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
268750|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
268751|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
268752|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
268753|NCT00033631|E2|Reported Event|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 44 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
268754|NCT00033631|E1|Reported Event|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
268755|NCT00033657|B3|Baseline|Total|Total of all reporting groups
268756|NCT00033657|B2|Baseline|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
268757|NCT00033657|B1|Baseline|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
268758|NCT00033657|P2|Participant Flow|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
268759|NCT00033657|P1|Participant Flow|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
268760|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
268761|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
268762|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
268763|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
268764|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
268765|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
268766|NCT00033657|E4|Reported Event|Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B)|
268767|NCT00033657|E3|Reported Event|Adjuvant_Cisplatin / Irinotecan / RT ( Arm A)|Adjuvant chemotherapy toxicities in treated patients
268768|NCT00033657|E2|Reported Event|Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
268829|NCT00035932|B4|Baseline|Total|Total of all reporting groups
269047|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
268769|NCT00033657|E1|Reported Event|Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy
Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
268770|NCT00035555|B4|Baseline|Total|Total of all reporting groups
268771|NCT00035555|B3|Baseline|Cyclosporine Regimen|Cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268772|NCT00035555|B2|Baseline|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268773|NCT00035555|B1|Baseline|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268774|NCT00035555|P3|Participant Flow|Cyclosporine Regimen|Cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268775|NCT00035555|P2|Participant Flow|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268776|NCT00035555|P1|Participant Flow|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268777|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268830|NCT00035932|B3|Baseline|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268831|NCT00035932|B2|Baseline|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268832|NCT00035932|B1|Baseline|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268778|NCT00035555|O2|Outcome|Belatacept:Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268779|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268780|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268781|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268782|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268783|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268784|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268785|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268833|NCT00035932|P3|Participant Flow|LPV / RTV|"lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268834|NCT00035932|P2|Participant Flow|ATV 400 mg / SQV|"ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268786|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268787|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268788|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268789|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268790|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268791|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268792|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268793|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268835|NCT00035932|P1|Participant Flow|ATV 300 mg / RTV|"atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268836|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268794|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268795|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268796|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268797|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268798|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268799|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268800|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268801|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268837|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268838|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
269048|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
268802|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268803|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268804|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268805|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268806|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268807|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268808|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268809|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268839|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268840|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
315917|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
268810|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268811|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268812|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268813|NCT00035555|E3|Reported Event|Cyclosporin Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268814|NCT00035555|E2|Reported Event|Belatacept: More-intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268815|NCT00035555|E1|Reported Event|Belatacept: Less-intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
268816|NCT00035815|B3|Baseline|Total|Total of all reporting groups
268817|NCT00035815|B2|Baseline|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
268818|NCT00035815|B1|Baseline|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
268819|NCT00035815|P2|Participant Flow|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
268820|NCT00035815|P1|Participant Flow|IGF-1|The insulin-like growth factor type 1 (IGF-1) arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
268821|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
268822|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
268823|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
268824|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
268825|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
268826|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
268827|NCT00035815|E2|Reported Event|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
268828|NCT00035815|E1|Reported Event|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
268841|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268842|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268843|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268844|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268845|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268846|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268847|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268848|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268849|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268850|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268851|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268852|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268853|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268854|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268855|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268856|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268857|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268858|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268859|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268860|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268861|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268862|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268863|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268864|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268865|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268866|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268867|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268868|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268869|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268870|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
315918|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
268871|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268872|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268873|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268874|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268875|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268876|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268877|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268878|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268879|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268880|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268881|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268882|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268883|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268884|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268885|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268886|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268887|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268888|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268889|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268890|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268891|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268892|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20])
268893|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21])
268894|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20])
268895|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21])
268896|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3])
268897|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19])
268898|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3])
268899|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19])
268900|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268901|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
269037|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
268902|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268903|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268904|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268905|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268906|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268907|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268908|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268909|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268910|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268911|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268912|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268913|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268914|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268915|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268916|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268917|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268918|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268919|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268920|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268921|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268922|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268923|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268924|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268925|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268926|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268927|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268928|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268929|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268930|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268931|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
315919|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
268932|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268933|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268934|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268935|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268936|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268937|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268938|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268939|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268940|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268941|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268942|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268943|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268944|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268945|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268946|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268947|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268948|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268949|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268950|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268951|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268952|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice
LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268953|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268954|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
268955|NCT00035932|E3|Reported Event|LPV/RTV|lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
268956|NCT00035932|E2|Reported Event|ATV400/SQV|ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
268957|NCT00035932|E1|Reported Event|ATV300/RTV|atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
268958|NCT00036270|B3|Baseline|Total|Total of all reporting groups
268959|NCT00036270|B2|Baseline|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
268960|NCT00036270|B1|Baseline|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
268961|NCT00036270|P2|Participant Flow|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
268962|NCT00036270|P1|Participant Flow|Exemestane|Exemestane (Aromasin®) 25 milligram (mg) once daily (QD) for 5 years.
269038|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
268963|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
268964|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
268965|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
268966|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
268967|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
268968|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
268969|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
268970|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
268971|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
268972|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
268973|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
268974|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
268975|NCT00036270|E2|Reported Event|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years
268976|NCT00036270|E1|Reported Event|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
268977|NCT00036569|B1|Baseline|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
268978|NCT00036569|P1|Participant Flow|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
268979|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
268980|NCT00036569|O2|Outcome|QOL Score at Follow-up|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
268981|NCT00036569|O1|Outcome|QOL Score at Baseline|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
268982|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
268983|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
268984|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
268985|NCT00036569|E1|Reported Event|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
268986|NCT00030823|B1|Baseline|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
268987|NCT00030823|P1|Participant Flow|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
268988|NCT00030823|O1|Outcome|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
268989|NCT00030823|E1|Reported Event|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
268990|NCT00043979|B3|Baseline|Total|Total of all reporting groups
268991|NCT00043979|B2|Baseline|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
268992|NCT00043979|B1|Baseline|Arm 1-Sibling Donors|Donors (n=30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.
268993|NCT00043979|P3|Participant Flow|Recipients Tacrolimus /Sirolimus Prophylaxis|"In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.
Post transplant recipients received tacrolimus & sirolimus for GVHD prophylaxis."
268994|NCT00043979|P2|Participant Flow|Recipients Cyclosporine GVHD Prophylaxis|"In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.
Post transplant recipients received cyclosporine for GVHD prophylaxis."
268995|NCT00043979|P1|Participant Flow|Sibling Donors|Donors (n = 30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.In period 1 they donated cells.
268996|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
268997|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
268998|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
268999|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
269000|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
269001|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
269002|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
269003|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
269004|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
269005|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
269006|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
269007|NCT00043979|O2|Outcome|Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis|
269008|NCT00043979|O1|Outcome|Recipients -Cyclosporine GVHD Prophylaxis|
269009|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
269010|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
269011|NCT00043979|E1|Reported Event|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
269012|NCT00044005|B4|Baseline|Total|Total of all reporting groups
269013|NCT00044005|B3|Baseline|Lurasidone 80mg|Lurasidone 80mg oral tablets
269014|NCT00044005|B2|Baseline|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
269015|NCT00044005|B1|Baseline|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
269016|NCT00044005|P3|Participant Flow|Lurasidone 80mg|Lurasidone 80mg oral tablets
269017|NCT00044005|P2|Participant Flow|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
269018|NCT00044005|P1|Participant Flow|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
269019|NCT00044005|O3|Outcome|Lurasidone 80mg|Lurasidone 80mg oral tablets
269020|NCT00044005|O2|Outcome|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
269021|NCT00044005|O1|Outcome|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
269022|NCT00044005|E3|Reported Event|Lurasidone 80mg|Lurasidone 80mg oral tablets
269023|NCT00044005|E2|Reported Event|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
269024|NCT00044005|E1|Reported Event|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
269025|NCT00044044|B6|Baseline|Total|Total of all reporting groups
269026|NCT00044044|B5|Baseline|Placebo|Oral Capsule matching treatment group taken oce a day
269027|NCT00044044|B4|Baseline|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 10 mg haloperidol treatment group did not take any study medication.
269028|NCT00044044|B3|Baseline|80 mg|Lurasidone 80 mg oral tablet taken once a day
269029|NCT00044044|B2|Baseline|40 mg|Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. Two subjects who were randomized to the 40 mg treatment group did not take any study medication.
269030|NCT00044044|B1|Baseline|20 mg|Lurasidone 20 mg oral tablet taken once a day
269031|NCT00044044|P5|Participant Flow|Placebo|Oral Capsule matching treatment group taken oce a day. The number of subjects in the participant flow for the placebo group(overall study) is based on the total number of subjects randomized in this treatment group.
269032|NCT00044044|P4|Participant Flow|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow for the haloperidol 10mg group(overall study) is based on the total number of subjects randomized in this treatment group.
269033|NCT00044044|P3|Participant Flow|80 mg|Lurasidone 80 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 80mg group(overall study) is based on the total number of subjects randomized in this treatment group.
269034|NCT00044044|P2|Participant Flow|40 mg|Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 40mg group(overall study) is based on the total number of subjects randomized in this treatment group.
269035|NCT00044044|P1|Participant Flow|20 mg|Lurasidone 20 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 20mg group(overall study) is based on the total number of subjects randomized in this treatment group.
269036|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
269039|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
269049|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
269050|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
269051|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
269052|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
269053|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
269054|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
269055|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
269056|NCT00044044|E5|Reported Event|Placebo|Oral Capsule matching treatment group taken oce a day
269057|NCT00044044|E4|Reported Event|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
269058|NCT00044044|E3|Reported Event|80 mg|Lurasidone 80 mg oral tablet taken once a day
269059|NCT00044044|E2|Reported Event|40 mg|Lurasidone 40 mg oral tablet taken once a day
269060|NCT00044044|E1|Reported Event|20 mg|Lurasidone 20 mg oral tablet taken once a day
269061|NCT00044213|B5|Baseline|Total|Total of all reporting groups
269062|NCT00044213|B4|Baseline|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
269063|NCT00044213|B3|Baseline|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
269064|NCT00044213|B2|Baseline|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
269065|NCT00044213|B1|Baseline|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
269066|NCT00044213|P4|Participant Flow|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
269067|NCT00044213|P3|Participant Flow|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
269068|NCT00044213|P2|Participant Flow|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
269069|NCT00044213|P1|Participant Flow|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
269070|NCT00044213|O4|Outcome|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
269071|NCT00044213|O3|Outcome|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
269072|NCT00044213|O2|Outcome|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
269073|NCT00044213|O1|Outcome|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
269074|NCT00044213|O4|Outcome|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
269075|NCT00044213|O3|Outcome|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
269076|NCT00044213|O2|Outcome|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
269077|NCT00044213|O1|Outcome|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
269078|NCT00044213|E4|Reported Event|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
269079|NCT00044213|E3|Reported Event|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
269080|NCT00044213|E2|Reported Event|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
269081|NCT00044213|E1|Reported Event|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
269082|NCT00046475|B3|Baseline|Total|Total of all reporting groups
269083|NCT00046475|B2|Baseline|Placebo/Midodrine|Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
269084|NCT00046475|B1|Baseline|Midodrine/Placebo|Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
269085|NCT00046475|P3|Participant Flow|Placebo/Midodrine|Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
269086|NCT00046475|P2|Participant Flow|Midodrine/Placebo|Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
269087|NCT00046475|P1|Participant Flow|All Enrolled Participants|All patients who were enrolled in this study are included in this population.
269088|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269089|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269090|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269091|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269092|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
269093|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
269094|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
269095|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269096|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269097|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269098|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269099|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269100|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269101|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269102|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269103|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269104|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269105|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269106|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269107|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269108|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269109|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269110|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269111|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269112|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269113|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269114|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269115|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
269116|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
269117|NCT00046475|E5|Reported Event|Follow-up|Patients were contacted 30 days after last study drug dose to follow up on any ongoing AEs and inquire if there were any new AEs.
269118|NCT00046475|E4|Reported Event|Placebo|Patients received Placebo for 2 weeks.
269119|NCT00046475|E3|Reported Event|Midodrine HCl|Patients received their optimum dose of Midodrine HCl for 2 weeks.
269120|NCT00046475|E2|Reported Event|Titration|Patients received different doses of drug for at least 2 weeks to determine the maximum tolerated dose.
269121|NCT00046475|E1|Reported Event|Screening/Washout|Patients signed the informed consent form and were screened for eligibility. Eligible patients were off drug for 1 week.
269122|NCT00046566|B4|Baseline|Total|Total of all reporting groups
269123|NCT00046566|B3|Baseline|Carbohydrate-soy Protein-milk Protein|Carbohydrate-soy protein-milk protein group
269124|NCT00046566|B2|Baseline|Milk Protein-carbohydrate-soy Protein|Milk protein-carbohydrate-soy protein group
269125|NCT00046566|B1|Baseline|Soy Protein-milk-protein-carbohydrate|Soy protein-milk-protein-carbohydrate group
269126|NCT00046566|P3|Participant Flow|Carbohydrate-soy Protein-milk Protein Group|118 participants assigned to carbohydrate-soy protein-milk protein group. They received 40 g/d carbohydrate for 8 weeks, then 40 g/d soy protein for 8 weeks, and finally 40 g/d milk protein for 8 weeks.
269127|NCT00046566|P2|Participant Flow|Milk Protein-carbohydrate-soy Protein Group|117 participants assigned to milk protein-carbohydrate-soy protein group. They received 40 g/d milk protein for 8 weeks, then 40 g/d carbohydrate for 8 weeks, and finally 40 g/d soy protein for 8 weeks.
269128|NCT00046566|P1|Participant Flow|Soy Protein-milk Protein-carbohydrate Group|117 participants assigned to soy protein-milk protein-carbohydrate group. They received 40 g/d soy protein for 8 weeks, then 40 g/d milk protein for 8 weeks, and finally 40 g/d carbohydrate for 8 weeks.
269129|NCT00046566|O3|Outcome|Carbohydrate Supplementation|Cross-over analysis carbohydrate supplementation
269130|NCT00046566|O2|Outcome|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
269131|NCT00046566|O1|Outcome|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
269132|NCT00046566|O3|Outcome|Carbohydrate Supplementation|Cross-over analysis carbohydrate supplementation
269133|NCT00046566|O2|Outcome|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
269134|NCT00046566|O1|Outcome|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
269135|NCT00046566|O3|Outcome|Carbohydrate Supplementation|Cross-over analysis of milk protein supplementation
269136|NCT00046566|O2|Outcome|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
269137|NCT00046566|O1|Outcome|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
269138|NCT00046566|E3|Reported Event|Carbohydrate Supplementation|Cross-over analysis carbohydrate supplementation
269139|NCT00046566|E2|Reported Event|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
269140|NCT00046566|E1|Reported Event|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
269141|NCT00046839|B3|Baseline|Total|Total of all reporting groups
269142|NCT00046839|B2|Baseline|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
269143|NCT00046839|B1|Baseline|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
269144|NCT00046839|P2|Participant Flow|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
269145|NCT00046839|P1|Participant Flow|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
269146|NCT00046839|O1|Outcome|Experimental: Phase I/II: Celecoxib 200 or 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 or 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
269147|NCT00046839|O2|Outcome|Phase I: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.
celecoxib
radiation therapy"
269148|NCT00046839|O1|Outcome|Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.
celecoxib
radiation therapy"
269149|NCT00046839|E2|Reported Event|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
269150|NCT00046839|E1|Reported Event|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
269151|NCT00046891|B3|Baseline|Total|Total of all reporting groups
269152|NCT00046891|B2|Baseline|Placebo|Placebo: Patients will take 1 tablet BID
269153|NCT00046891|B1|Baseline|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
269154|NCT00046891|P2|Participant Flow|Placebo|Placebo: Patients will take 1 tablet BID
269155|NCT00046891|P1|Participant Flow|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
269156|NCT00046891|O3|Outcome|Make Decisions|Self-report cognition
269157|NCT00046891|O2|Outcome|Plan Ahead|Self-report cognition
269158|NCT00046891|O1|Outcome|Solve Problems|Self-report cognition
269159|NCT00046891|O3|Outcome|Balance Checkbook|Self-report cognition
269160|NCT00046891|O2|Outcome|Think Clearly|Self-report cognition
269161|NCT00046891|O1|Outcome|Stay Focused|Self-report cognition
269162|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
269163|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
269164|NCT00046891|O2|Outcome|Placebo|Median change from baseline to different time points.
269165|NCT00046891|O1|Outcome|Ginko Bibola|Median change from baseline to different time points.
269166|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
269167|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
269168|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
269169|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
269170|NCT00046891|E2|Reported Event|Placebo|Placebo: Patients will take 1 tablet BID
269171|NCT00046891|E1|Reported Event|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
269172|NCT00046930|B3|Baseline|Total|Total of all reporting groups
269173|NCT00046930|B2|Baseline|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
269174|NCT00046930|B1|Baseline|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
269175|NCT00046930|P2|Participant Flow|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
269176|NCT00046930|P1|Participant Flow|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
269177|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
269178|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
269179|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
269180|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
269181|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
269182|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
269183|NCT00046930|E5|Reported Event|Placebo Consolidation II|Consolidation with Daunorubicin, Cytarabine and Placebo
269184|NCT00046930|E4|Reported Event|Zosuquidar Consolidation II|Consolidation with Daunorubicin, Cytarabine and Zosuquidar
269185|NCT00046930|E3|Reported Event|Consolidation I|Cytarabine 1500 mg/m2 days 1-6
269186|NCT00046930|E2|Reported Event|Placebo Induction|Induction treatment with daunorubicin, cytarabine and placebo
269187|NCT00046930|E1|Reported Event|Zosuquidar Induction|Induction treatment with daunorubicin, cytarabine and zosuquidar
269188|NCT00047008|B3|Baseline|Total|Total of all reporting groups
269189|NCT00047008|B2|Baseline|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
269190|NCT00047008|B1|Baseline|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
269191|NCT00047008|P2|Participant Flow|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
269192|NCT00047008|P1|Participant Flow|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
269193|NCT00047008|O2|Outcome|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
269194|NCT00047008|O1|Outcome|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
269195|NCT00047008|E2|Reported Event|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
269196|NCT00047008|E1|Reported Event|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
269197|NCT00047320|B1|Baseline|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.
carboplatin: Given IV
etoposide: Given IV
ifosfamide: Given IV
radiation therapy: craniospinal irradiation"
269198|NCT00047320|P1|Participant Flow|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.
carboplatin: Given IV
etoposide: Given IV
ifosfamide: Given IV
radiation therapy: craniospinal irradiation"
269199|NCT00047320|O1|Outcome|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.
carboplatin: Given IV
etoposide: Given IV
ifosfamide: Given IV
thiotepa: Given IV
adjuvant therapy
conventional surgery
neoadjuvant therapy
peripheral blood stem cell transplantation
radiation therapy: craniospinal irradiation"
269200|NCT00047320|E1|Reported Event|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.
carboplatin: Given IV
etoposide: Given IV
ifosfamide: Given IV
radiation therapy: craniospinal irradiation"
269201|NCT00047385|B3|Baseline|Total|Total of all reporting groups
269202|NCT00047385|B2|Baseline|Chest X-ray|Participants undergo chest x-ray examination.
269203|NCT00047385|B1|Baseline|Low-Dose CT|Participants undergo low-dose helical CT examination.
269204|NCT00047385|P2|Participant Flow|Chest X-ray|Participants undergo chest x-ray examination.
269205|NCT00047385|P1|Participant Flow|Low-Dose CT|Participants undergo low-dose helical CT examination.
269206|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
269207|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
269208|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
269209|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
269210|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
269211|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
269212|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
269213|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
269214|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
269215|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
269216|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
269217|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
269218|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
269219|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
269220|NCT00047385|E2|Reported Event|Chest X-ray|Participants undergo chest x-ray examination.
269221|NCT00047385|E1|Reported Event|Low-Dose CT|Participants undergo low-dose helical CT examination.
269222|NCT00047463|B3|Baseline|Total|Total of all reporting groups
269223|NCT00047463|B2|Baseline|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
269224|NCT00047463|B1|Baseline|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
269225|NCT00047463|P2|Participant Flow|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
269226|NCT00047463|P1|Participant Flow|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
269227|NCT00047463|O1|Outcome|All Participants Prior to Randomization|
269228|NCT00047463|O2|Outcome|Placebo-CPAP|Placebo-CPAP: Placebo-CPAP
269229|NCT00047463|O1|Outcome|Continuous Positive Airway Pressure (CPAP)|continuous positive airway pressure (CPAP): a mask treatment for sleep apnea
269230|NCT00047463|O2|Outcome|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
269231|NCT00047463|O1|Outcome|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
269232|NCT00047463|E2|Reported Event|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
269233|NCT00047463|E1|Reported Event|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
269234|NCT00047619|B3|Baseline|Total|Total of all reporting groups
269235|NCT00047619|B2|Baseline|Sham Lavage Group|"sham pulsatile lavage
sham pulsatile lavage: pulsatile lavage not directed at wound or patient"
269236|NCT00047619|B1|Baseline|Pulsatile Lavage Group|"pulsatile lavage therapy
Pulsatile Lavage: pulsatile lavage to wound bed"
269237|NCT00047619|P2|Participant Flow|Sham Lavage Group|"sham pulsatile lavage
sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
269238|NCT00047619|P1|Participant Flow|Pulsatile Lavage Group|"pulsatile lavage therapy
Pulsatile Lavage: pulsatile lavage to wound bed"
269239|NCT00047619|O2|Outcome|Sham Lavage Group|"sham pulsatile lavage
sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
269240|NCT00047619|O1|Outcome|Pulsatile Lavage Group|"pulsatile lavage therapy
Pulsatile Lavage: pulsatile lavage to wound bed"
269241|NCT00047619|O2|Outcome|Sham Lavage Group|"sham pulsatile lavage
sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
269242|NCT00047619|O1|Outcome|Pulsatile Lavage Group|"pulsatile lavage therapy
Pulsatile Lavage: pulsatile lavage to wound bed"
269243|NCT00047619|E2|Reported Event|Sham Lavage Group|"sham pulsatile lavage
sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
269244|NCT00047619|E1|Reported Event|Pulsatile Lavage Group|"pulsatile lavage therapy
Pulsatile Lavage: pulsatile lavage to wound bed"
269245|NCT00047879|B3|Baseline|Total|Total of all reporting groups
269246|NCT00047879|B2|Baseline|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
269247|NCT00047879|B1|Baseline|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
269248|NCT00047879|P2|Participant Flow|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
269249|NCT00047879|P1|Participant Flow|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
269250|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
269251|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
269252|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
269253|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
269254|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
269255|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
269256|NCT00047879|E2|Reported Event|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
269257|NCT00047879|E1|Reported Event|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
269258|NCT00048035|B7|Baseline|Total|Total of all reporting groups
269342|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269259|NCT00048035|B6|Baseline|Cohort 6 (RO0503821 [0.6/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269260|NCT00048035|B5|Baseline|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269261|NCT00048035|B4|Baseline|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269262|NCT00048035|B3|Baseline|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269263|NCT00048035|B2|Baseline|Cohort 2 (RO0503821 [0.25/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269264|NCT00048035|B1|Baseline|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269265|NCT00048035|P8|Participant Flow|RO0503821 (1x/2Week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269266|NCT00048035|P7|Participant Flow|RO0503821 (1x/Week)|Eligible participants were administered intravenously (IV) RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) once weekly (1x/ week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269267|NCT00048035|P6|Participant Flow|Cohort 6 (RO0503821 [0.6/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269268|NCT00048035|P5|Participant Flow|Cohort 5 (RO0503821 [0.6/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269269|NCT00048035|P4|Participant Flow|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269270|NCT00048035|P3|Participant Flow|Cohort 3 (RO0503821 [0.4/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269271|NCT00048035|P2|Participant Flow|Cohort 2 (RO0503821 [0.25/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269272|NCT00048035|P1|Participant Flow|Cohort 1 (RO0503821 [0.25/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269273|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269274|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269275|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269276|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269277|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269278|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269279|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269280|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269281|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269282|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269283|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269284|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269285|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269286|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269287|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269288|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269289|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269290|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269291|NCT00048035|O2|Outcome|RO0503821 (1x/2Week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269292|NCT00048035|O1|Outcome|RO0503821 (1x/Week)|Eligible participants were administered IV RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
270063|NCT00039741|P4|Participant Flow|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
269293|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269294|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269295|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269296|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269297|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269298|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269299|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269300|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269301|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269302|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269303|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269304|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269305|NCT00048035|E2|Reported Event|RO0503821 (1/2week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269306|NCT00048035|E1|Reported Event|RO0503821 (1/Week)|Eligible participants were administered IV RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
269307|NCT00048061|B5|Baseline|Total|Total of all reporting groups
269308|NCT00048061|B4|Baseline|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269309|NCT00048061|B3|Baseline|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269310|NCT00048061|B2|Baseline|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269311|NCT00048061|B1|Baseline|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269312|NCT00048061|P4|Participant Flow|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269313|NCT00048061|P3|Participant Flow|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269314|NCT00048061|P2|Participant Flow|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269315|NCT00048061|P1|Participant Flow|Ibandronate 2.5 mg|Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day.
269316|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269317|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269318|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269319|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269320|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269321|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269322|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269323|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269324|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269325|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269326|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269327|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269328|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269329|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269330|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269331|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269332|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269333|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269334|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269335|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269336|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269337|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269338|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269339|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269340|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269341|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
315920|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
269343|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269344|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269345|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269346|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269347|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269348|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269349|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269350|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269351|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269352|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269353|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269354|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269355|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269356|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269357|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269358|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269359|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269360|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269361|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269362|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269363|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269364|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269365|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269366|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269367|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269368|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269369|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269370|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269371|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
270064|NCT00039741|P3|Participant Flow|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
269372|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269373|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269374|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269375|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269376|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269377|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269378|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269379|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269380|NCT00048061|E4|Reported Event|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269381|NCT00048061|E3|Reported Event|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269382|NCT00048061|E2|Reported Event|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269383|NCT00048061|E1|Reported Event|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
269384|NCT00048074|B4|Baseline|Total|Total of all reporting groups
269385|NCT00048074|B3|Baseline|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269386|NCT00048074|B2|Baseline|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269387|NCT00048074|B1|Baseline|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269388|NCT00048074|P3|Participant Flow|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269389|NCT00048074|P2|Participant Flow|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269390|NCT00048074|P1|Participant Flow|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269391|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269392|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269393|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269394|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269395|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269396|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269397|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269398|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269399|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269400|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269401|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269402|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269403|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
270146|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
269404|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269405|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269406|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269407|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269408|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269409|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269410|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269411|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269412|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269413|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269414|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269415|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269416|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269417|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269418|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269419|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269420|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269421|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269422|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269423|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269424|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269425|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269426|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269427|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269428|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269429|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269430|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269431|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269432|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269433|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269434|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269435|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269436|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269437|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269438|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269439|NCT00048074|E3|Reported Event|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
269440|NCT00048074|E2|Reported Event|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
269441|NCT00048074|E1|Reported Event|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
269442|NCT00048165|B3|Baseline|Total|Total of all reporting groups
269443|NCT00048165|B2|Baseline|Placebo|Eligible participants were administered an intravenous matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269444|NCT00048165|B1|Baseline|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269445|NCT00048165|P2|Participant Flow|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269446|NCT00048165|P1|Participant Flow|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269447|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269448|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269449|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269450|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269451|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269452|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269453|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269454|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269506|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269455|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269456|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269457|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269458|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269459|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269460|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269461|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269462|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269463|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269464|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269465|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269466|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269467|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269468|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269507|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269469|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269470|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269471|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269472|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269473|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269474|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269475|NCT00048165|E2|Reported Event|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269476|NCT00048165|E1|Reported Event|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
269477|NCT00048347|B1|Baseline|Avonex|30 µg IM every week for 12 weeks
269478|NCT00048347|P1|Participant Flow|Avonex|30 µg IM every week for 12 weeks
269479|NCT00048347|O1|Outcome|Avonex|30 µg IM every week for 12 weeks
269480|NCT00048347|E1|Reported Event|Avonex|30 µg IM every week for 12 weeks
269481|NCT00048542|B5|Baseline|Total|Total of all reporting groups
269482|NCT00048542|B4|Baseline|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
269483|NCT00048542|B3|Baseline|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
269484|NCT00048542|B2|Baseline|Double-Blind Placebo + MTX|"Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.
MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening."
269485|NCT00048542|B1|Baseline|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
269486|NCT00048542|P8|Participant Flow|Open-Label Extension FD Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269508|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269487|NCT00048542|P7|Participant Flow|Open-Label Extension FD Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269488|NCT00048542|P6|Participant Flow|Open-Label Extension BSA Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
269489|NCT00048542|P5|Participant Flow|Open-Label Extension BSA Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
269490|NCT00048542|P4|Participant Flow|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
269491|NCT00048542|P3|Participant Flow|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
269492|NCT00048542|P2|Participant Flow|Double-Blind Placebo + MTX|"Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.
MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening."
269493|NCT00048542|P1|Participant Flow|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
269494|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269495|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269496|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269497|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269498|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
269499|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
269500|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
269501|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
269502|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269503|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269504|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269505|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269857|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269509|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269510|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
269511|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
269512|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
269513|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
269514|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
269515|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
269516|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
269517|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
269518|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
269519|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
269520|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
269521|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
269522|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
269523|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
269524|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
269525|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
269526|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
269527|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
269528|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
269529|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.
269530|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
269531|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.
269532|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
269533|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.
269534|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
269535|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.
269536|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
269537|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
269538|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
269539|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
269540|NCT00048542|O2|Outcome|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
269541|NCT00048542|O1|Outcome|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
270056|NCT00033917|E2|Reported Event|IVH Negative Placebo|These subjects also had no evidence for IVH at 6 - 12 hours. They were randomized to an equal volume of placebo.
315921|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
269542|NCT00048542|O2|Outcome|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
269543|NCT00048542|O1|Outcome|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
269544|NCT00048542|O2|Outcome|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
269545|NCT00048542|O1|Outcome|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
269546|NCT00048542|O2|Outcome|Adalimumab|Subjects received open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]), but no methotrexate (MTX), during the Open-Label Lead-In (OL-LI) Phase of the study.
269547|NCT00048542|O1|Outcome|Adalimumab + MTX|Subjects received methotrexate (MTX) plus open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]) during the Open-Label Lead-In (OL-LI) Phase of the study.
269548|NCT00048542|O2|Outcome|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
269549|NCT00048542|O1|Outcome|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
269550|NCT00048542|E8|Reported Event|Open-Label Extension FD Adalimumab|Subjects in the methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269551|NCT00048542|E7|Reported Event|Open-Label Extension FD Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
269552|NCT00048542|E6|Reported Event|Open-Label Extension BSA Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
269553|NCT00048542|E5|Reported Event|Open-Label Extension BSA Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
269554|NCT00048542|E4|Reported Event|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
269555|NCT00048542|E3|Reported Event|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
269556|NCT00048542|E2|Reported Event|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
269557|NCT00048542|E1|Reported Event|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
269558|NCT00048568|B3|Baseline|Total|Total of all reporting groups
269559|NCT00048568|B2|Baseline|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269560|NCT00048568|B1|Baseline|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269561|NCT00048568|P3|Participant Flow|ABA + MTX [Open-label (OL)]|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269562|NCT00048568|P2|Participant Flow|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269563|NCT00048568|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
269564|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269565|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269566|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269567|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269568|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269569|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269570|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269571|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269572|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269573|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269574|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269575|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269576|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269577|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269578|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269579|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269580|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269581|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269582|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269583|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269584|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269585|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269586|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269587|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269588|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269589|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269590|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269591|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269640|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269592|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269593|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269594|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269595|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269596|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269597|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269598|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269599|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269600|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269601|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269602|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269603|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269604|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269605|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269606|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269607|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269710|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269608|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269609|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269610|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269611|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269612|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269613|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269614|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269615|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269616|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269617|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269618|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269619|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269620|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269621|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269622|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269623|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269711|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269624|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269625|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269626|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269627|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269628|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269629|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269630|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269631|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269632|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269633|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269634|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269635|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269636|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269637|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269638|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269639|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
270689|NCT00053703|P2|Participant Flow|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
269641|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269642|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269643|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269644|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269645|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269646|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269647|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269648|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269649|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269650|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269651|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269652|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269653|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269654|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269655|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269656|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269657|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269658|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269659|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
270065|NCT00039741|P2|Participant Flow|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
269660|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269661|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269662|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269663|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269664|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269665|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269666|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269667|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269668|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269669|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269670|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269671|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269672|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269673|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269674|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269675|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269712|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269676|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269677|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269678|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269679|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269680|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269681|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269682|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269683|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269684|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269685|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269686|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269687|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269688|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269689|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269690|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269691|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269713|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269692|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269693|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269694|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269695|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269696|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269697|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269698|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269699|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269700|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269701|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269702|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269703|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269704|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269705|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269706|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269707|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269708|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269709|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
270057|NCT00033917|E1|Reported Event|IVH Negative Indomethacin|Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
270058|NCT00039741|B5|Baseline|Total|Total of all reporting groups
269714|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269715|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269716|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269717|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269718|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269719|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269720|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269721|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269722|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269723|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269724|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269725|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269726|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269727|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269728|NCT00048568|O1|Outcome|ABA + MTX Cumulative DB + OL Periods|Abatacept was dosed intravenously by weight at 10 mg/kg in the DB and OL periods under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269729|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269746|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
270397|NCT00051025|E1|Reported Event|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
269730|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269731|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269732|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269733|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269734|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269735|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269736|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269737|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269738|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269739|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269740|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269741|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269742|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269743|NCT00048568|O2|Outcome|MTX + Placebo|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269744|NCT00048568|O1|Outcome|ABA + MTX|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269745|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269747|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269748|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269749|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269750|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269751|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269752|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269753|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269754|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269755|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269756|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269757|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269758|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269759|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269760|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269761|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269762|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
270398|NCT00051168|B1|Baseline|Travatan|Travoprost (0.004%)
269763|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the DB period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
269764|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269765|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269766|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269767|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269768|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269769|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269770|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269771|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269772|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269773|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269774|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269775|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269776|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269777|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269778|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269779|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
270399|NCT00051168|P1|Participant Flow|Travatan|Travoprost (0.004%)
269780|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269781|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269782|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269783|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269784|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269785|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269786|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269787|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269788|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269789|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269790|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269791|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269792|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269793|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269794|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
270059|NCT00039741|B4|Baseline|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
269795|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269796|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269797|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269798|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269799|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269800|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269801|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269802|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269803|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269804|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269805|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269806|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269807|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269808|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269809|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269825|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
270400|NCT00051168|O1|Outcome|Travatan|Travoprost (0.004%)
269810|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269811|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269812|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269813|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269814|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269815|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269816|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269817|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269818|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269819|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269820|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269821|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269822|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269823|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269824|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
270060|NCT00039741|B3|Baseline|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
269826|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269827|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269828|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269829|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269830|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269831|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269832|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269833|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269834|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269835|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269836|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269837|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269838|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
269839|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269840|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
269841|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
270401|NCT00051168|E1|Reported Event|Travatan|Travoprost (0.004%)
269842|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269843|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269844|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269845|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269846|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269847|NCT00048568|E3|Reported Event|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
269848|NCT00048568|E2|Reported Event|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
269849|NCT00048568|E1|Reported Event|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
269850|NCT00048581|B3|Baseline|Total|Total of all reporting groups
269851|NCT00048581|B2|Baseline|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269852|NCT00048581|B1|Baseline|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269853|NCT00048581|P3|Participant Flow|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
269854|NCT00048581|P2|Participant Flow|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269855|NCT00048581|P1|Participant Flow|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269856|NCT00048581|O1|Outcome|All Treated Participants|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269858|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269859|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269860|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269861|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269862|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269863|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269864|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269865|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269866|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269867|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269868|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269869|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269870|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269871|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269872|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269873|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269874|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269875|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269876|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269877|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269878|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269879|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269880|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269881|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
270061|NCT00039741|B2|Baseline|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
270402|NCT00051363|B3|Baseline|Total|Total of all reporting groups
269882|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269883|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269884|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269885|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269886|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269887|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269888|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269889|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269890|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269891|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269892|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269893|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269894|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269895|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269896|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269897|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269898|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269899|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269900|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269901|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269902|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269903|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269904|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269905|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
270062|NCT00039741|B1|Baseline|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
270446|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
269906|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269907|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269908|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269909|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269910|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269911|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269912|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269913|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269914|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269915|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269916|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269917|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269918|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269919|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269920|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269921|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269922|NCT00048581|O1|Outcome|OL: ABA|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269923|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269924|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269925|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269926|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269927|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269928|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269929|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269930|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269931|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269932|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269933|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269934|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269935|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269936|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269937|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269938|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269939|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269940|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269941|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269942|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
269943|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
269944|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
269945|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
269946|NCT00048581|O1|Outcome|All Treated DB Participants|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269947|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
269948|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269949|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269950|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269951|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269952|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269953|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269954|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269955|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269956|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269957|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269958|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269959|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269960|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269961|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
315922|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
269962|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269963|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269964|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269965|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269966|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269967|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269968|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269969|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269970|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269971|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269972|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269973|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269974|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269975|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
315923|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
269976|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269977|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269978|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269979|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269980|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269981|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269982|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269983|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269984|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269985|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269986|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269987|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269988|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269989|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
315924|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
269990|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269991|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269992|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269993|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269994|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269995|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269996|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269997|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
269998|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
269999|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
270000|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
270001|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
270002|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
270003|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
315925|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
270004|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
270005|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
270006|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
270007|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
270008|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
270009|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
270010|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
270011|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
270012|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
270013|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
270014|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
270015|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
270016|NCT00048581|E3|Reported Event|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
270017|NCT00048581|E2|Reported Event|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
270018|NCT00048581|E1|Reported Event|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
270019|NCT00048724|B3|Baseline|Total|Total of all reporting groups
270020|NCT00048724|B2|Baseline|Untreated Control|
270021|NCT00048724|B1|Baseline|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
270022|NCT00048724|P2|Participant Flow|Untreated Control|
270023|NCT00048724|P1|Participant Flow|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
270024|NCT00048724|O2|Outcome|Untreated Control|
270025|NCT00048724|O1|Outcome|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
270026|NCT00048724|O2|Outcome|Untreated Control|
270027|NCT00048724|O1|Outcome|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
270028|NCT00048724|E2|Reported Event|Untreated Control|
270029|NCT00048724|E1|Reported Event|PegIntron|
270030|NCT00048737|B1|Baseline|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
Rituximab : 250 mg/m^2 on day 1 and day 8
Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy
Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals
Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
Fludarabine : 30 mg/m^2/day x 3"
270031|NCT00048737|P1|Participant Flow|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
Rituximab : 250 mg/m^2 on day 1 and day 8
Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy
Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals
Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
Fludarabine : 30 mg/m^2/day x 3"
270032|NCT00048737|O1|Outcome|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
Rituximab: 250 mg/m^2 on day 1 and day 8
Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy
Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals
Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
Fludarabine : 30 mg/m^2/day x 3"
270033|NCT00048737|E1|Reported Event|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
Rituximab : 250 mg/m^2 on day 1 and day 8
Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy
Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals
Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
Fludarabine : 30 mg/m^2/day x 3"
270034|NCT00048893|B1|Baseline|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
270035|NCT00048893|P1|Participant Flow|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
270036|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
270037|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
270038|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
270039|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
270040|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
270041|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
270042|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
270043|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
270044|NCT00048893|E1|Reported Event|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
270045|NCT00033917|B3|Baseline|Total|Total of all reporting groups
270046|NCT00033917|B2|Baseline|Placebo|Group randomized to an equal volume of placebo
270047|NCT00033917|B1|Baseline|Indomethacin|subjects randomized to early low dose indomethacin
270048|NCT00033917|P2|Participant Flow|IVH Negative Placebo|These subjects also had no evidence for IVH at 6 - 12 hours. They were randomized to an equal volume of placebo.
270049|NCT00033917|P1|Participant Flow|IVH Negative Indomethacin|Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
270050|NCT00033917|O4|Outcome|Placebo - IVH|Randomized to placebo; had IVH
270051|NCT00033917|O3|Outcome|Placebo - no IVH|Randomized to placebo - no IVH
270052|NCT00033917|O2|Outcome|Indomethacin - IVH|Randomized to indomethacin; had IVH
270053|NCT00033917|O1|Outcome|Indomethacin - no IVH|Subjects randomized to indomethacin and had no IVH
270054|NCT00033917|O2|Outcome|Placebo|Group randomized to an equal volume of placebo
270055|NCT00033917|O1|Outcome|Indomethacin|subjects randomized to early low dose indomethacin
270066|NCT00039741|P1|Participant Flow|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
270067|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
270068|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
270069|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
270070|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
270071|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
270072|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
270073|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
270074|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
270075|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
270076|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
270077|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
270078|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
270079|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
270080|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
270081|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
270082|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
270083|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
270084|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
270085|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
270086|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
270087|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
270088|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
270089|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
270090|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
270091|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
270092|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
270093|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
270094|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
270095|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
270096|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
270097|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
270098|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
270099|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
270100|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
270101|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
270102|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
270103|NCT00039741|E4|Reported Event|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
270104|NCT00039741|E3|Reported Event|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
270105|NCT00039741|E2|Reported Event|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
270106|NCT00039741|E1|Reported Event|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
270107|NCT00039871|B1|Baseline|PegIntron Plus Rebetol|
270108|NCT00039871|P1|Participant Flow|PegIntron Plus Rebetol|
270109|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
270110|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
270111|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
270112|NCT00039871|E1|Reported Event|PegIntron Plus Rebetol|
270447|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270113|NCT00040365|B1|Baseline|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
270114|NCT00040365|P1|Participant Flow|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
270115|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
270116|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
270117|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
270118|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
270119|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
270120|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
270121|NCT00040365|E1|Reported Event|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
270122|NCT00040664|B1|Baseline|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
270123|NCT00040664|P4|Participant Flow|12-18 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 12-18 years
270124|NCT00040664|P3|Participant Flow|6-11 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 6-11 years
270125|NCT00040664|P2|Participant Flow|2-5 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 2-5 years
270126|NCT00040664|P1|Participant Flow|Overall Fosamprenavir (FPV)/Ritonavir(RTV)|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
270127|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
270128|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
270129|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
270130|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
270131|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
270132|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
270133|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
270134|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
270135|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
270136|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
270137|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
270138|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
270139|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
270140|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
270141|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
270142|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
270143|NCT00040664|O1|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
270144|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
270145|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
270448|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270147|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
270148|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
270149|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
270150|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
270151|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
270152|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
270153|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a PI
270154|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
270155|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
270156|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
270157|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
270158|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
270159|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
270160|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
270161|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
270162|NCT00040664|O1|Outcome|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
270163|NCT00040664|O2|Outcome|FPV Oral Suspension|Fosamprenavir 50 mg/mL oral suspension/ritonavir 80 mg/mL oral solution once daily
270164|NCT00040664|O1|Outcome|FPV Tablet|Fosamprenavir 700 mg tablets/ritonavir 100 mg capsules once daily
270165|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
270166|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a PI
270167|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
270168|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
270169|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
270170|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
270171|NCT00040664|O1|Outcome|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
270172|NCT00040664|E1|Reported Event|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
270173|NCT00040742|B5|Baseline|Total|Total of all reporting groups
270174|NCT00040742|B4|Baseline|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally"
270175|NCT00040742|B3|Baseline|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
placebo: Given orally"
270176|NCT00040742|B2|Baseline|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
placebo: Given orally"
270177|NCT00040742|B1|Baseline|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally"
270178|NCT00040742|P4|Participant Flow|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally"
270179|NCT00040742|P3|Participant Flow|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
placebo: Given orally"
270180|NCT00040742|P2|Participant Flow|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
placebo: Given orally"
270181|NCT00040742|P1|Participant Flow|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally"
270182|NCT00040742|O4|Outcome|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally"
270183|NCT00040742|O3|Outcome|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
placebo: Given orally"
270184|NCT00040742|O2|Outcome|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
placebo: Given orally"
270185|NCT00040742|O1|Outcome|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally"
270186|NCT00040742|O4|Outcome|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally"
270187|NCT00040742|O3|Outcome|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
placebo: Given orally"
270188|NCT00040742|O2|Outcome|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
placebo: Given orally"
270189|NCT00040742|O1|Outcome|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally"
270190|NCT00040742|E4|Reported Event|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally"
270191|NCT00040742|E3|Reported Event|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
placebo: Given orally"
270192|NCT00040742|E2|Reported Event|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger extract: Given orally
placebo: Given orally"
270193|NCT00040742|E1|Reported Event|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo: Given orally"
270194|NCT00040846|B7|Baseline|Total|Total of all reporting groups
270195|NCT00040846|B6|Baseline|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270196|NCT00040846|B5|Baseline|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270197|NCT00040846|B4|Baseline|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270198|NCT00040846|B3|Baseline|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270199|NCT00040846|B2|Baseline|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270200|NCT00040846|B1|Baseline|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO"
270201|NCT00040846|P6|Participant Flow|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270202|NCT00040846|P5|Participant Flow|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270263|NCT00041080|O1|Outcome|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
270264|NCT00041080|E2|Reported Event|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
270265|NCT00041080|E1|Reported Event|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
270203|NCT00040846|P4|Participant Flow|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270204|NCT00040846|P3|Participant Flow|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270205|NCT00040846|P2|Participant Flow|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270206|NCT00040846|P1|Participant Flow|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO"
270207|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270208|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270209|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270210|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270211|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270266|NCT00041119|B5|Baseline|Total|Total of all reporting groups
270267|NCT00041119|B4|Baseline|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
270350|NCT00049127|P5|Participant Flow|Study 3 Arm E|"Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens
Imatinib at 300 mg b.i.d."
270212|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO"
270213|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270214|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270215|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270216|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270217|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270218|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO"
270219|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270220|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270268|NCT00041119|B3|Baseline|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
270269|NCT00041119|B2|Baseline|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
270690|NCT00053703|P1|Participant Flow|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
270221|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270222|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270223|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270224|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO"
270225|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270226|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270227|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270228|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270229|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270270|NCT00041119|B1|Baseline|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
270271|NCT00041119|P4|Participant Flow|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
270230|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO"
270231|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270232|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270233|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270234|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270235|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270236|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO"
270237|NCT00040846|E6|Reported Event|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270238|NCT00040846|E5|Reported Event|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270272|NCT00041119|P3|Participant Flow|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
270273|NCT00041119|P2|Participant Flow|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
315926|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
270239|NCT00040846|E4|Reported Event|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270240|NCT00040846|E3|Reported Event|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270241|NCT00040846|E2|Reported Event|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO
alemtuzumab: Given IV"
270242|NCT00040846|E1|Reported Event|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation
mycophenolate mofetil: Given PO
cyclosporine: Given IV or PO"
270243|NCT00040937|B1|Baseline|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
270244|NCT00040937|P1|Participant Flow|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
270245|NCT00040937|O1|Outcome|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
270246|NCT00040937|O1|Outcome|Induction/PBSC Mobilization|
270247|NCT00040937|E3|Reported Event|Prednisone + Thalidomide|
270248|NCT00040937|E2|Reported Event|Autologous PBSCT|
270249|NCT00040937|E1|Reported Event|Induction/PBSC Mobilization|
270250|NCT00041067|B1|Baseline|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim
docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles
vinorelbine : 27.5 mg/m^2 on Days 8 and 15
filgrastim : 5 microg/kg/day on Days 2 to 21
trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
270251|NCT00041067|P1|Participant Flow|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim
docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles
vinorelbine : 27.5 mg/m^2 on Days 8 and 15
filgrastim : 5 microg/kg/day on Days 2 to 21
trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
270252|NCT00041067|O1|Outcome|Docetaxel + Vinorelbine + G-CSF + Trastuzumab|
270253|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim
docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles
vinorelbine : 27.5 mg/m^2 on Days 8 and 15
filgrastim : 5 microg/kg/day on Days 2 to 21
trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
270254|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim
docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles
vinorelbine : 27.5 mg/m^2 on Days 8 and 15
filgrastim : 5 microg/kg/day on Days 2 to 21
trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
270255|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim
docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles
vinorelbine : 27.5 mg/m^2 on Days 8 and 15
filgrastim : 5 microg/kg/day on Days 2 to 21
trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
270256|NCT00041067|E1|Reported Event|Docetaxel + Vinorelbine + G-CSF + Trastuzumab|
270257|NCT00041080|B3|Baseline|Total|Total of all reporting groups
270258|NCT00041080|B2|Baseline|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
270259|NCT00041080|B1|Baseline|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
270260|NCT00041080|P2|Participant Flow|Grp - 2|Tamoxifen 20mg orally twice daily for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
270261|NCT00041080|P1|Participant Flow|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
270262|NCT00041080|O2|Outcome|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
315927|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
270274|NCT00041119|P1|Participant Flow|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
270275|NCT00041119|O2|Outcome|4 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 4 cycles or Paclitaxel for 4 cycles
270276|NCT00041119|O1|Outcome|6 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 6 cycles or Paclitaxel for 6 cycles
270277|NCT00041119|O2|Outcome|Paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
270278|NCT00041119|O1|Outcome|Cyclophosphamide and Doxorubicin Hydrochloride|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
270279|NCT00041119|O2|Outcome|Paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
270280|NCT00041119|O1|Outcome|Cyclophosphamide and Doxorubicin Hydrochloride|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
270281|NCT00041119|O2|Outcome|4 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 4 cycles or Paclitaxel for 4 cycles
270282|NCT00041119|O1|Outcome|6 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 6 cycles or Paclitaxel for 6 cycles
270283|NCT00041119|O2|Outcome|Paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
270284|NCT00041119|O1|Outcome|Cyclophosphamide and Doxorubicin Hydrochloride|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
270285|NCT00041119|O2|Outcome|Arm VI (Arm III and Arm IV) Combined|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
270286|NCT00041119|O1|Outcome|Arm V (Arm I and Arm II Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
270287|NCT00041119|O2|Outcome|6 Cycles (Arm II and Arm IV Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
270288|NCT00041119|O1|Outcome|4 Cycles (Arm I and Arm III Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
270289|NCT00041119|E4|Reported Event|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
270290|NCT00041119|E3|Reported Event|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
270291|NCT00041119|E2|Reported Event|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
270292|NCT00041119|E1|Reported Event|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
270293|NCT00041132|B1|Baseline|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.
Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.
Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
270294|NCT00041132|P1|Participant Flow|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.
Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.
Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
270295|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.
Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.
Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
270296|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.
Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.
Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
270691|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
270297|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.
Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.
Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
270298|NCT00041132|E1|Reported Event|Hyper-CVAD + MTX/Ara-C + Rituximab|
270299|NCT00048932|B3|Baseline|Total|Total of all reporting groups
270300|NCT00048932|B2|Baseline|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270301|NCT00048932|B1|Baseline|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270302|NCT00048932|P3|Participant Flow|Open Label (OL) Abatacept|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
270303|NCT00048932|P2|Participant Flow|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270304|NCT00048932|P1|Participant Flow|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270305|NCT00048932|O1|Outcome|All Treated Participants|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
270306|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
270307|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
270308|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
270309|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
270310|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
270311|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
270312|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
270313|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270314|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270315|NCT00048932|O1|Outcome|All Treated Participants|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
270316|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270317|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270318|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270319|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270320|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270321|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270322|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270323|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270324|NCT00048932|E3|Reported Event|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270325|NCT00048932|E2|Reported Event|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for subjects < 60 kg, 750 mg for subjects 60 to 100 kg and 1 g for subjects > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
270326|NCT00048932|E1|Reported Event|Open Label (OL) Abatacept|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
270327|NCT00048997|B3|Baseline|Total|Total of all reporting groups
270328|NCT00048997|B2|Baseline|Observation|Observation.
270329|NCT00048997|B1|Baseline|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
270330|NCT00048997|P2|Participant Flow|Observation|Observation
270331|NCT00048997|P1|Participant Flow|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
270332|NCT00048997|O2|Outcome|Observation|Observation
270333|NCT00048997|O1|Outcome|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
270334|NCT00048997|E1|Reported Event|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy..
270335|NCT00049036|B3|Baseline|Total|Total of all reporting groups
270336|NCT00049036|B2|Baseline|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
270337|NCT00049036|B1|Baseline|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
270338|NCT00049036|P2|Participant Flow|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
270339|NCT00049036|P1|Participant Flow|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
270340|NCT00049036|O2|Outcome|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
270341|NCT00049036|O1|Outcome|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
270342|NCT00049036|E2|Reported Event|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
270343|NCT00049036|E1|Reported Event|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
270344|NCT00049127|B6|Baseline|Total|Total of all reporting groups
270345|NCT00049127|B5|Baseline|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
270346|NCT00049127|B4|Baseline|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
270347|NCT00049127|B3|Baseline|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
270348|NCT00049127|B2|Baseline|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
270349|NCT00049127|B1|Baseline|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
315928|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
270351|NCT00049127|P4|Participant Flow|Study 3 Arm D|"Phase II patients on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens
Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily"
270352|NCT00049127|P3|Participant Flow|Study 2 Arm B|"Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens
Imatinib at 300 mg b.i.d."
270353|NCT00049127|P2|Participant Flow|Study 2 Arm A|"Phase II patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens
Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily"
270354|NCT00049127|P1|Participant Flow|Study 1 Arm C|"Phase I patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens
Imatinib at assigned dose. Escalation of cohorts-of-3 per section 7.1 of the protocol. Assigned dose will be administered p.o. twice daily in divided doses."
270355|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
270356|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
270357|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
270358|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
270359|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
270360|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
270361|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
270362|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
270363|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
270364|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
270365|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
270366|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
270367|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
270368|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
270369|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
270370|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
270371|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
270372|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
270373|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
270374|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
270375|NCT00049127|E5|Reported Event|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
270376|NCT00049127|E4|Reported Event|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
270377|NCT00049127|E3|Reported Event|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
270378|NCT00049127|E2|Reported Event|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
270379|NCT00049127|E1|Reported Event|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
270380|NCT00049257|B1|Baseline|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
270381|NCT00049257|P1|Participant Flow|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
270382|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
270383|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
270384|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
270385|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
270386|NCT00049257|E1|Reported Event|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
270387|NCT00051025|B3|Baseline|Total|Total of all reporting groups
270388|NCT00051025|B2|Baseline|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
270389|NCT00051025|B1|Baseline|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
270390|NCT00051025|P2|Participant Flow|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
270391|NCT00051025|P1|Participant Flow|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
270392|NCT00051025|O2|Outcome|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
270393|NCT00051025|O1|Outcome|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
270394|NCT00051025|O2|Outcome|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
270395|NCT00051025|O1|Outcome|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
270396|NCT00051025|E2|Reported Event|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
270403|NCT00051363|B2|Baseline|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270404|NCT00051363|B1|Baseline|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270405|NCT00051363|P2|Participant Flow|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270406|NCT00051363|P1|Participant Flow|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270407|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270408|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270409|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270410|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270411|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270412|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270413|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270414|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270415|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270416|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270417|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270418|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270419|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270420|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270421|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270422|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270423|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270424|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270425|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270426|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270427|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270428|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270429|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270430|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270431|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270432|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270433|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270434|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270435|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270436|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270437|NCT00051363|E2|Reported Event|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
270438|NCT00051363|E1|Reported Event|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
270439|NCT00051558|B3|Baseline|Total|Total of all reporting groups
270440|NCT00051558|B2|Baseline|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270441|NCT00051558|B1|Baseline|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270442|NCT00051558|P2|Participant Flow|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270443|NCT00051558|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270444|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270445|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270449|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270450|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270451|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270452|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270453|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270454|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270455|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270456|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270457|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270458|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270459|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270460|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270461|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270462|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270463|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270464|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270465|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270466|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270467|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270468|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270469|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270470|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270471|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270472|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270473|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270474|NCT00051558|E2|Reported Event|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
270475|NCT00051558|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
270476|NCT00051636|B3|Baseline|Total|Total of all reporting groups
270477|NCT00051636|B2|Baseline|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270478|NCT00051636|B1|Baseline|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270479|NCT00051636|P2|Participant Flow|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270480|NCT00051636|P1|Participant Flow|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270481|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270482|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270483|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270484|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270485|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270486|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270508|NCT00052078|B2|Baseline|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks
Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
270487|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270488|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270489|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270490|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270491|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270492|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270493|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270494|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270495|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270496|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270497|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270498|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270499|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270500|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270501|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270502|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270503|NCT00051636|E2|Reported Event|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270504|NCT00051636|E1|Reported Event|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
270505|NCT00052078|B5|Baseline|Total|Total of all reporting groups
270506|NCT00052078|B4|Baseline|4 Placebo|"Participants will receive placebo for 12 weeks
Placebo: Participants will take placebo capsules for 12 weeks."
270507|NCT00052078|B3|Baseline|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks.
Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
270686|NCT00053703|B2|Baseline|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
270509|NCT00052078|B1|Baseline|1 Setraline|"Participants will receive sertraline for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks."
270510|NCT00052078|P4|Participant Flow|4 Placebo|"Participants will receive placebo for 12 weeks
Placebo: Participants will take placebo capsules for 12 weeks."
270511|NCT00052078|P3|Participant Flow|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks.
Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
270512|NCT00052078|P2|Participant Flow|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks
Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
270513|NCT00052078|P1|Participant Flow|1 Setraline|"Participants will receive sertraline for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks."
270514|NCT00052078|O4|Outcome|4 Placebo|"Participants will receive placebo for 12 weeks
Placebo: Participants will take placebo capsules for 12 weeks."
270515|NCT00052078|O3|Outcome|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks.
Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
270516|NCT00052078|O2|Outcome|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks
Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
270517|NCT00052078|O1|Outcome|1 Setraline|"Participants will receive sertraline for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks."
270518|NCT00052078|E4|Reported Event|4 Placebo|"Participants will receive placebo for 12 weeks
Placebo: Participants will take placebo capsules for 12 weeks."
270519|NCT00052078|E3|Reported Event|3 Combination Setraline + CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks.
Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
270520|NCT00052078|E2|Reported Event|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks
Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
270521|NCT00052078|E1|Reported Event|1 Setraline|"Participants will receive sertraline for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks."
270522|NCT00052429|B1|Baseline|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I
Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
270523|NCT00052429|P1|Participant Flow|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I
Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
270524|NCT00052429|O1|Outcome|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I
Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
270525|NCT00052429|O1|Outcome|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I
Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
270526|NCT00052429|E1|Reported Event|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I
Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
270527|NCT00052715|B1|Baseline|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri
Poly-ICLC drug
poly ICLC"
270528|NCT00052715|P1|Participant Flow|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri
Poly-ICLC drug
poly ICLC"
270687|NCT00053703|B1|Baseline|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
270529|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy
Intramuscular injection
Drug Poly-ICLC
poly ICLC"
270530|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy
Intramuscular injection
Drug Poly-ICLC
poly ICLC"
270531|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy
Intramuscular injection
Drug Poly-ICLC
poly ICLC"
270532|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy
Intramuscular injection
Drug Poly-ICLC
poly ICLC"
270533|NCT00052715|E1|Reported Event|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri
Poly-ICLC drug
poly ICLC"
270534|NCT00052962|B3|Baseline|Total|Total of all reporting groups
270535|NCT00052962|B2|Baseline|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy
Cytoreductive surgery
continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin
post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2
post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
270536|NCT00052962|B1|Baseline|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery
Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
270537|NCT00052962|P2|Participant Flow|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy
Cytoreductive surgery
continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin
post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2
post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
270538|NCT00052962|P1|Participant Flow|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery
Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
270539|NCT00052962|O2|Outcome|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy
Cytoreductive surgery
continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin
post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2
post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
270540|NCT00052962|O1|Outcome|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery
Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
270541|NCT00052962|O2|Outcome|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy
Cytoreductive surgery
continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin
post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2
post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
270542|NCT00052962|O1|Outcome|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery
Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
270543|NCT00052962|E2|Reported Event|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy
Cytoreductive surgery
continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin
post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2
post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
270544|NCT00052962|E1|Reported Event|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery
Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
270545|NCT00053014|B1|Baseline|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
270546|NCT00053014|P1|Participant Flow|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
270547|NCT00053014|O1|Outcome|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
270548|NCT00053014|O1|Outcome|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
270549|NCT00053014|E1|Reported Event|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
270550|NCT00053365|B1|Baseline|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
270551|NCT00053365|P1|Participant Flow|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
270552|NCT00053365|O1|Outcome|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
270553|NCT00053365|O1|Outcome|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
270554|NCT00053365|E1|Reported Event|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
270555|NCT00053417|B5|Baseline|Total|Total of all reporting groups
270556|NCT00053417|B4|Baseline|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
270557|NCT00053417|B3|Baseline|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
270558|NCT00053417|B2|Baseline|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
270559|NCT00053417|B1|Baseline|Placebo|Placebo control
270560|NCT00053417|P4|Participant Flow|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
270561|NCT00053417|P3|Participant Flow|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
270562|NCT00053417|P2|Participant Flow|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
270563|NCT00053417|P1|Participant Flow|Placebo|Placebo control
270564|NCT00053417|O4|Outcome|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
270565|NCT00053417|O3|Outcome|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
270566|NCT00053417|O2|Outcome|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
270567|NCT00053417|O1|Outcome|Placebo|Placebo control
270568|NCT00053417|E4|Reported Event|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
270569|NCT00053417|E3|Reported Event|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
270570|NCT00053417|E2|Reported Event|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
270571|NCT00053417|E1|Reported Event|Placebo|Placebo control
270572|NCT00053482|B6|Baseline|Total|Total of all reporting groups
270573|NCT00053482|B5|Baseline|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270574|NCT00053482|B4|Baseline|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
270575|NCT00053482|B3|Baseline|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
270576|NCT00053482|B2|Baseline|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
270577|NCT00053482|B1|Baseline|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270578|NCT00053482|P5|Participant Flow|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270579|NCT00053482|P4|Participant Flow|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
270580|NCT00053482|P3|Participant Flow|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
270581|NCT00053482|P2|Participant Flow|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
270582|NCT00053482|P1|Participant Flow|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270583|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270584|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
270585|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
270586|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
270587|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270588|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270589|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
270590|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
270591|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
270592|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270593|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270594|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
270595|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
270596|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
270597|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270598|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270599|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
270600|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
270601|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
270602|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270603|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270604|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
270605|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
270606|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
270607|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270608|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270609|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
270610|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
270611|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
270612|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270613|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270614|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
270615|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
270616|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
270617|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270618|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270619|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
270620|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
270621|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
270622|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270623|NCT00053482|E5|Reported Event|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270624|NCT00053482|E4|Reported Event|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
270625|NCT00053482|E3|Reported Event|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
270626|NCT00053482|E2|Reported Event|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
270627|NCT00053482|E1|Reported Event|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
270628|NCT00053495|B6|Baseline|Total|Total of all reporting groups
270629|NCT00053495|B5|Baseline|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270630|NCT00053495|B4|Baseline|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
270631|NCT00053495|B3|Baseline|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
270632|NCT00053495|B2|Baseline|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
270633|NCT00053495|B1|Baseline|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270634|NCT00053495|P5|Participant Flow|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270635|NCT00053495|P4|Participant Flow|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
270636|NCT00053495|P3|Participant Flow|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
270637|NCT00053495|P2|Participant Flow|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
270638|NCT00053495|P1|Participant Flow|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270639|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270640|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
270641|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
270688|NCT00053703|P3|Participant Flow|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
270642|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
270643|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270644|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270645|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
270646|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
270647|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
270648|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270649|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270650|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
270651|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
270652|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
270653|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270654|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270655|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
270656|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
270657|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
270658|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270659|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270660|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
270661|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
270662|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
270663|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270664|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270665|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
270666|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
270667|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
270668|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270669|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270670|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
270671|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
270672|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
270673|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270674|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270675|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
270676|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
270677|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
270678|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270679|NCT00053495|E5|Reported Event|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270680|NCT00053495|E4|Reported Event|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
270681|NCT00053495|E3|Reported Event|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
270682|NCT00053495|E2|Reported Event|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
270683|NCT00053495|E1|Reported Event|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
270684|NCT00053703|B4|Baseline|Total|Total of all reporting groups
270685|NCT00053703|B3|Baseline|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
270692|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
270693|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
270694|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
270695|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
270696|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
270697|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
270698|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
270699|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
270700|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
270701|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
270702|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
270703|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
270704|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
270705|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
270706|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
270707|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
270708|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
270709|NCT00053703|E3|Reported Event|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
270710|NCT00053703|E2|Reported Event|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
270711|NCT00053703|E1|Reported Event|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
270712|NCT00053846|B3|Baseline|Total|Total of all reporting groups
270713|NCT00053846|B2|Baseline|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
270714|NCT00053846|B1|Baseline|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
270715|NCT00053846|P2|Participant Flow|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
270716|NCT00053846|P1|Participant Flow|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
270717|NCT00053846|O2|Outcome|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
270718|NCT00053846|O1|Outcome|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
270719|NCT00053846|E2|Reported Event|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
270720|NCT00053846|E1|Reported Event|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
270721|NCT00044512|B1|Baseline|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
270722|NCT00044512|P1|Participant Flow|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
270723|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
270724|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
270725|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
270726|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
270727|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
270728|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
270729|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
270730|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
270731|NCT00044512|E1|Reported Event|Sorafenib 400 mg b.i.d.|"Sorafenib (Nexavar, BAY43-9006) 400 mg administered b.i.d.Other AE section includes SAEs"
270732|NCT00044655|B3|Baseline|Total|Total of all reporting groups
270733|NCT00044655|B2|Baseline|Switch|Participants will change medications from medication prescribed at study entry
270734|NCT00044655|B1|Baseline|Stay|Participants will continue taking medication prescribed at study entry
270735|NCT00044655|P2|Participant Flow|Switch|Participants will change medications from medication prescribed at study entry
270736|NCT00044655|P1|Participant Flow|Stay|Participants will continue taking medication prescribed at study entry
270737|NCT00044655|O2|Outcome|Switch|Participants will change medications from medication prescribed at study entry
270738|NCT00044655|O1|Outcome|Stay|Participants will continue taking medication prescribed at study entry
270739|NCT00044655|E2|Reported Event|Switch|Participants will change medications from medication prescribed at study entry
270740|NCT00044655|E1|Reported Event|Stay|Participants will continue taking medication prescribed at study entry
270741|NCT00045032|B4|Baseline|Total|Total of all reporting groups
270917|NCT00045110|O1|Outcome|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis"
270742|NCT00045032|B3|Baseline|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270743|NCT00045032|B2|Baseline|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270744|NCT00045032|B1|Baseline|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270745|NCT00045032|P3|Participant Flow|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270746|NCT00045032|P2|Participant Flow|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270747|NCT00045032|P1|Participant Flow|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270748|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270749|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270750|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270751|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270752|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270753|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270754|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270755|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270756|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270787|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270757|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270758|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270759|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270760|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270761|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270762|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270763|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270764|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270765|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270766|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270767|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270768|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270769|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270770|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270771|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270772|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270773|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270774|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270775|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270776|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270777|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270778|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270779|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270780|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270781|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270782|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270783|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270784|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270785|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270786|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
271193|NCT00056407|B1|Baseline|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
315929|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
270788|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270789|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270790|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270791|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270792|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270793|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270794|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270795|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270796|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270797|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270798|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270799|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270800|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270801|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270802|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270803|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270804|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270805|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270806|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270807|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270808|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270809|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270810|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270811|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270812|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270813|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270814|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270815|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270816|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270817|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270818|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270819|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270820|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270821|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270822|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270823|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270824|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270825|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270826|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270827|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270828|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270829|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270830|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270831|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270832|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270833|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270834|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270900|NCT00045110|O7|Outcome|Phase 1 Dose Escalation - 775 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270835|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270836|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270837|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270838|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270839|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270840|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270841|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270842|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270843|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270844|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270845|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270846|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270847|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270848|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270849|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270850|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
271652|NCT00050089|O1|Outcome|ARDFP|This includes participants randomized to ARDFP (ARDFP+Standard-ART or ARDFP+Mega-ART)
270851|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270852|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270853|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270854|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270855|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270856|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270857|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270858|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270859|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270860|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270861|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270862|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270863|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270864|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270865|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270866|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270867|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270868|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270869|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
270870|NCT00045032|E3|Reported Event|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270871|NCT00045032|E2|Reported Event|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
270872|NCT00045032|E1|Reported Event|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided. After the release of initial study results, participants in the Observation Arm were allowed to cross over to receive adjuvant Herceptin prior to disease recurrence. As such, adverse events that occurred after crossover were not included in the safety analyses for this arm.
270873|NCT00045110|B4|Baseline|Total|Total of all reporting groups
270874|NCT00045110|B3|Baseline|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis"
270875|NCT00045110|B2|Baseline|Phase 2 w/ Recurrent Malignant Glioma|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib at a predetermined dose (150mg/day).
Patients requiring surgery were treated 7 days prior to tumor removal PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR) erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis"
270876|NCT00045110|B1|Baseline|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis."
270877|NCT00045110|P3|Participant Flow|Phase 2 - Newly Diagnosed GBM Post RT|Patients with GBM with newly diagnosed disease following Radiation (RT) started erlotinib no more than 6 weeks from the completion of RT. Temozolomide or other adjuvant chemotherapy not allowed while on erotinib
270878|NCT00045110|P2|Participant Flow|Phase 2 - Recurrent Malignant Glioma|"Phase II: Once the MTD is determined, additional patients concurrently receiving EIAEDs are treated with erlotinib as above at the phase II dose.
Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.
patients requiring surgery were treated 7 days prior to tumor removal; PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis."
270879|NCT00045110|P1|Participant Flow|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis."
270880|NCT00045110|O1|Outcome|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis"
270881|NCT00045110|O1|Outcome|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis"
270882|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.
patients requiring surgery were treated 7 days prior to tumor removal
PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis.
erlotinib hydrochloride: given orally
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
270883|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.
patients requiring surgery were treated 7 days prior to tumor removal
PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis.
erlotinib hydrochloride: given orally
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
270884|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.
patients requiring surgery were treated 7 days prior to tumor removal
PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis.
erlotinib hydrochloride: given orally
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
270885|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.
patients requiring surgery were treated 7 days prior to tumor removal
PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis.
erlotinib hydrochloride: given orally
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
270886|NCT00045110|O7|Outcome|Phase 1 Dose Escalation - 775 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270887|NCT00045110|O6|Outcome|Phase 1 Dose Escalation - 650 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270888|NCT00045110|O5|Outcome|Phase 1 Dose Escalation - 525 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270889|NCT00045110|O4|Outcome|Phase 1 Dose Escalation - 400 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270890|NCT00045110|O3|Outcome|Phase 1 Dose Escalation - 275 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270891|NCT00045110|O2|Outcome|Phase 1 Dose Escalation - 200 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270892|NCT00045110|O1|Outcome|Phase 1 Dose Escalation - 150 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Other: pharmacological study, laboratory biomarker analysis."
270893|NCT00045110|O7|Outcome|Phase 1 Dose Escalation - 775 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270894|NCT00045110|O6|Outcome|Phase 1 Dose Escalation - 650 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270895|NCT00045110|O5|Outcome|Phase 1 Dose Escalation - 525 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270896|NCT00045110|O4|Outcome|Phase 1 Dose Escalation - 400 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270897|NCT00045110|O3|Outcome|Phase 1 Dose Escalation - 275 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270898|NCT00045110|O2|Outcome|Phase 1 Dose Escalation - 200 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270899|NCT00045110|O1|Outcome|Phase 1 Dose Escalation - 150 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Other: pharmacological study, laboratory biomarker analysis."
270916|NCT00045110|O1|Outcome|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis"
315930|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
270901|NCT00045110|O6|Outcome|Phase 1 Dose Escalation - 650 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270902|NCT00045110|O5|Outcome|Phase 1 Dose Escalation - 525 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270903|NCT00045110|O4|Outcome|Phase 1 Dose Escalation - 400 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270904|NCT00045110|O3|Outcome|Phase 1 Dose Escalation - 275 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270905|NCT00045110|O2|Outcome|Phase 1 Dose Escalation - 200 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270906|NCT00045110|O1|Outcome|Phase 1 Dose Escalation - 150 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Other: pharmacological study, laboratory biomarker analysis."
270907|NCT00045110|O7|Outcome|Phase 1 Dose Escalation - 775 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270908|NCT00045110|O6|Outcome|Phase 1 Dose Escalation - 650 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270909|NCT00045110|O5|Outcome|Phase 1 Dose Escalation - 525 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270910|NCT00045110|O4|Outcome|Phase 1 Dose Escalation - 400 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270911|NCT00045110|O3|Outcome|Phase 1 Dose Escalation - 275 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270912|NCT00045110|O2|Outcome|Phase 1 Dose Escalation - 200 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
270913|NCT00045110|O1|Outcome|Phase 1 Dose Escalation - 150 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Other: pharmacological study, laboratory biomarker analysis."
270914|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas and Stable Disease Post RT|"Patients with recurrent malignant gliomas not concurrently receiving EIAEDs treated with erlotinib at a predetermined dose.
patients requiring surgery were treated 7 days prior to tumor removal
PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis.
erlotinib hydrochloride: given orally
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
270915|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.
patients requiring surgery were treated 7 days prior to tumor removal
PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis.
erlotinib hydrochloride: given orally
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
271022|NCT00045942|P4|Participant Flow|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
270918|NCT00045110|O1|Outcome|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs (on Enzyme-inducing Antiepileptic Drugs) receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Other: pharmacological study, laboratory biomarker analysis..
erlotinib hydrochloride: given orally
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
270919|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.
patients requiring surgery were treated 7 days prior to tumor removal
PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis.
erlotinib hydrochloride: given orally
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
270920|NCT00045110|O1|Outcome|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs ( on Enzyme-inducing Antiepileptic Drugs) receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Other: pharmacological study, laboratory biomarker analysis."
270921|NCT00045110|O1|Outcome|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs ( on Enzyme-inducing Antiepileptic Drugs ) receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Other: pharmacological study, laboratory biomarker analysis."
270922|NCT00045110|E2|Reported Event|Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.
patients requiring surgery were treated 7 days prior to tumor removal; PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis."
270923|NCT00045110|E1|Reported Event|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
erlotinib hydrochloride given orally
Other: pharmacological study, laboratory biomarker analysis."
270924|NCT00045162|B3|Baseline|Total|Total of all reporting groups
270925|NCT00045162|B2|Baseline|Cisplatin + Etoposide|
270926|NCT00045162|B1|Baseline|Cisplatin + Irinotecan|
270927|NCT00045162|P2|Participant Flow|Cisplatin + Etoposide|
270928|NCT00045162|P1|Participant Flow|Cisplatin + Irinotecan|
270929|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
270930|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
270931|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
270932|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
270933|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
270934|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
270935|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
270936|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
270937|NCT00045162|E2|Reported Event|Cisplatin + Etoposide|
270938|NCT00045162|E1|Reported Event|Cisplatin + Irinotecan|
270939|NCT00045305|B1|Baseline|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
270940|NCT00045305|P1|Participant Flow|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
270941|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite"
271195|NCT00056407|P1|Participant Flow|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
270942|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite"
270943|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite"
270944|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite"
270945|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite"
270946|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite"
270947|NCT00045305|E1|Reported Event|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
270948|NCT00045435|B1|Baseline|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.
Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant
Fludarabine phosphate: Given IV
Total-body irradiation: Undergo total-body irradiation
Cyclosporine: Given PO
Mycophenolate mofetil: Given PO
Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
270949|NCT00045435|P1|Participant Flow|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.
Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant
Fludarabine phosphate: Given IV
Total-body irradiation: Undergo total-body irradiation
Cyclosporine: Given PO
Mycophenolate mofetil: Given PO
Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
271023|NCT00045942|P3|Participant Flow|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
315931|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
270950|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.
Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant
Fludarabine phosphate: Given IV
Total-body irradiation: Undergo total-body irradiation
Cyclosporine: Given PO
Mycophenolate mofetil: Given PO
Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
270951|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.
Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant
Fludarabine phosphate: Given IV
Total-body irradiation: Undergo total-body irradiation
Cyclosporine: Given PO
Mycophenolate mofetil: Given PO
Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
270952|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.
Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant
Fludarabine phosphate: Given IV
Total-body irradiation: Undergo total-body irradiation
Cyclosporine: Given PO
Mycophenolate mofetil: Given PO
Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
270953|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.
Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant
Fludarabine phosphate: Given IV
Total-body irradiation: Undergo total-body irradiation
Cyclosporine: Given PO
Mycophenolate mofetil: Given PO
Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
270954|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.
Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant
Fludarabine phosphate: Given IV
Total-body irradiation: Undergo total-body irradiation
Cyclosporine: Given PO
Mycophenolate mofetil: Given PO
Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
270955|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.
Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant
Fludarabine phosphate: Given IV
Total-body irradiation: Undergo total-body irradiation
Cyclosporine: Given PO
Mycophenolate mofetil: Given PO
Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
270956|NCT00045435|E1|Reported Event|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.
Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant
Fludarabine phosphate: Given IV
Total-body irradiation: Undergo total-body irradiation
Cyclosporine: Given PO
Mycophenolate mofetil: Given PO
Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
270957|NCT00045487|B1|Baseline|OSI-774|Once-daily oral administration for 4 weeks.
270958|NCT00045487|P1|Participant Flow|OSI-774|OSI-774, continuous daily oral administration of 150mg until disease progression or 52 weeks duration. Dose adjustment, reduction by increments of 50mg will be made for dose-limiting toxicity.
270959|NCT00045487|O1|Outcome|OSI-774|Once-daily oral administration for 4 weeks.
270960|NCT00045487|E1|Reported Event|OSI-774|Once-daily oral administration for 4 weeks.
270961|NCT00045630|B1|Baseline|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
270962|NCT00045630|P1|Participant Flow|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
270963|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
270964|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
270965|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
271024|NCT00045942|P2|Participant Flow|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
272785|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
270966|NCT00045630|E1|Reported Event|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
270967|NCT00045708|B4|Baseline|Total|Total of all reporting groups
270968|NCT00045708|B3|Baseline|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
270969|NCT00045708|B2|Baseline|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
Pharmacological Study
ixabepilone: Given IV
pharmacological study: Correlative studies"
270970|NCT00045708|B1|Baseline|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
Pharmacological Study
ixabepilone: Given IV pharmacological study: Correlative studies"
270971|NCT00045708|P3|Participant Flow|Group 3 - MTD Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
270972|NCT00045708|P2|Participant Flow|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
Pharmacological Study
ixabepilone: Given IV
pharmacological study: Correlative studies"
270973|NCT00045708|P1|Participant Flow|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
Pharmacological Study
ixabepilone: Given IV
pharmacological study: Correlative studies"
270974|NCT00045708|O1|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
270975|NCT00045708|O1|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD (6.8mg/m2).
270976|NCT00045708|O3|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
270977|NCT00045708|O2|Outcome|Group B [No Anticonvulsants] Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
Pharmacological Study
ixabepilone: Given IV
pharmacological study: Correlative studies"
270978|NCT00045708|O1|Outcome|Group A [Anticonvulsants] Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Pharmacological Study Phase 1"
270979|NCT00045708|O3|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
270980|NCT00045708|O2|Outcome|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
Pharmacological Study
ixabepilone: Given IV
pharmacological study: Correlative studies"
270981|NCT00045708|O1|Outcome|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
Pharmacological Study
ixabepilone: Given IV pharmacological study: Correlative studies"
270982|NCT00045708|O1|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
270983|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Pharmacological Study Phase 1
ixabepilone: Given IV
pharmacological study: Correlative studies"
270999|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
270984|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Pharmacological Study Phase 1
ixabepilone: Given IV
pharmacological study: Correlative studies"
270985|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Pharmacological Study Phase 1
ixabepilone: Given IV
pharmacological study: Correlative studies"
270986|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Pharmacological Study Phase 1
ixabepilone: Given IV
pharmacological study: Correlative studies"
270987|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Pharmacological Study Phase 1
ixabepilone: Given IV
pharmacological study: Correlative studies"
270988|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Pharmacological Study Phase 1
ixabepilone: Given IV
pharmacological study: Correlative studies"
270989|NCT00045708|O3|Outcome|Group 3 - MTD (6.8mg/m2/Day) Phase 2|"Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
ixabepilone: Given IV
MTD for no anticonvulsant arm = 6.8mg/m2/day MTD for anticonvulsant arm = 9.6mg/m2/day
Only no anticonvulsant subjects at 6.8mg/m2/day treated in Phase 2"
270990|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Pharmacological Study
ixabepilone: Given IV
pharmacological study: Correlative studies"
270991|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Pharmacological Study
ixabepilone: Given IV
pharmacological study: Correlative studies"
270992|NCT00045708|E3|Reported Event|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
270993|NCT00045708|E2|Reported Event|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
Pharmacological Study
ixabepilone: Given IV
pharmacological study: Correlative studies"
270994|NCT00045708|E1|Reported Event|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.
Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
Pharmacological Study
ixabepilone: Given IV pharmacological study: Correlative studies"
270995|NCT00045734|B1|Baseline|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
270996|NCT00045734|P1|Participant Flow|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
270997|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
270998|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
271021|NCT00045942|P5|Participant Flow|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271000|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
271001|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
271002|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
271003|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
271004|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
271005|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
271006|NCT00045734|E1|Reported Event|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
271007|NCT00045942|B10|Baseline|Total|Total of all reporting groups
271008|NCT00045942|B9|Baseline|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271009|NCT00045942|B8|Baseline|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271010|NCT00045942|B7|Baseline|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271011|NCT00045942|B6|Baseline|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271012|NCT00045942|B5|Baseline|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271013|NCT00045942|B4|Baseline|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271014|NCT00045942|B3|Baseline|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271015|NCT00045942|B2|Baseline|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271016|NCT00045942|B1|Baseline|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271017|NCT00045942|P9|Participant Flow|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271018|NCT00045942|P8|Participant Flow|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271019|NCT00045942|P7|Participant Flow|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271020|NCT00045942|P6|Participant Flow|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271196|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271025|NCT00045942|P1|Participant Flow|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271026|NCT00045942|O4|Outcome|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271027|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271028|NCT00045942|O2|Outcome|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271029|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271030|NCT00045942|O4|Outcome|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271031|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271032|NCT00045942|O2|Outcome|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271033|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271034|NCT00045942|O4|Outcome|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271035|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271036|NCT00045942|O2|Outcome|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271037|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271038|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 200 mg/Day|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271039|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 200 mg/Day|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271040|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 200 mg/Day|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271041|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 100 mg/Day Arms Combined|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271042|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 100 mg/Day Arms Combined|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271043|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 100 mg/Day Arms Combined|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271044|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271045|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271046|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271194|NCT00056407|P2|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271047|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271048|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271049|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271050|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271051|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271052|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271053|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271054|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271055|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271056|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271057|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271058|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271059|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271060|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271061|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271062|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271063|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271064|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 Dose Escalation Combined|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271065|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 Dose Escalation Combined|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271066|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 Dose Escalation Combined|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271067|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271068|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271069|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271070|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271091|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271071|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271072|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271073|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271074|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271075|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271076|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271077|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271078|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271079|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271080|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271081|NCT00045942|O4|Outcome|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271082|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271083|NCT00045942|O2|Outcome|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271084|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271085|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271086|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271087|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271088|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271089|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271090|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271092|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271093|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271094|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271095|NCT00045942|E9|Reported Event|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271096|NCT00045942|E8|Reported Event|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271097|NCT00045942|E7|Reported Event|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
271098|NCT00045942|E6|Reported Event|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
271099|NCT00045942|E5|Reported Event|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271100|NCT00045942|E4|Reported Event|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271101|NCT00045942|E3|Reported Event|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271102|NCT00045942|E2|Reported Event|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271103|NCT00045942|E1|Reported Event|PKC412 Core|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
271104|NCT00046228|B4|Baseline|Total|Total of all reporting groups
271105|NCT00046228|B3|Baseline|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271106|NCT00046228|B2|Baseline|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271107|NCT00046228|B1|Baseline|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271108|NCT00046228|P3|Participant Flow|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271109|NCT00046228|P2|Participant Flow|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271110|NCT00046228|P1|Participant Flow|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271111|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271112|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271113|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271114|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271115|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271116|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271117|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271118|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271119|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271120|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271121|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271122|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271123|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271124|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271125|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271126|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271127|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271128|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271129|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271130|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271131|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271132|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271133|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271134|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271135|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271136|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271137|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271138|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271139|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271140|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271141|NCT00046228|E3|Reported Event|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
271142|NCT00046228|E2|Reported Event|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
271143|NCT00046228|E1|Reported Event|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
271144|NCT00054028|B3|Baseline|Total|Total of all reporting groups
271145|NCT00054028|B2|Baseline|Suramin and Paclitaxel (Phase II)|Patients receive paclitaxel in combination with the target dose of suramin.
271146|NCT00054028|B1|Baseline|Suramin and Paclitaxel (Phase I)|Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.
271147|NCT00054028|P1|Participant Flow|Treatment (Suramin and Paclitaxel)|"PHASE I: Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.
PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above."
271148|NCT00054028|O1|Outcome|Treatment (Suramin and Paclitaxel)|PHASE II: Patients receive paclitaxel in combination with the target dose of suramin the same as Phase I.
271149|NCT00054028|O1|Outcome|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
271150|NCT00054028|O1|Outcome|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
271151|NCT00054028|E1|Reported Event|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
271152|NCT00054132|B1|Baseline|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
271153|NCT00054132|P1|Participant Flow|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
271192|NCT00056407|B2|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271154|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|"Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Erlotinib Hydrochloride: Given PO
Laboratory Biomarker Analysis: Correlative studies"
271155|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|"Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Erlotinib Hydrochloride: Given PO
Laboratory Biomarker Analysis: Correlative studies"
271156|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
271157|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
271158|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
271159|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
271160|NCT00054132|E1|Reported Event|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
271161|NCT00056160|B3|Baseline|Total|Total of all reporting groups
271162|NCT00056160|B2|Baseline|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
271163|NCT00056160|B1|Baseline|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
271164|NCT00056160|P2|Participant Flow|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
271165|NCT00056160|P1|Participant Flow|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
271166|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
271167|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
271168|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
271169|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
271170|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
271171|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
271172|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
271173|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
271174|NCT00056160|E2|Reported Event|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
271175|NCT00056160|E1|Reported Event|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
271176|NCT00056316|B3|Baseline|Total|Total of all reporting groups
271177|NCT00056316|B2|Baseline|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
271178|NCT00056316|B1|Baseline|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
271179|NCT00056316|P2|Participant Flow|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
271180|NCT00056316|P1|Participant Flow|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
271181|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
271182|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
271183|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
271184|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
271185|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
271186|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
271187|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
271188|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
271189|NCT00056316|E2|Reported Event|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
271190|NCT00056316|E1|Reported Event|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
271191|NCT00056407|B3|Baseline|Total|Total of all reporting groups
315932|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
271197|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271198|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271199|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271200|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271201|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271202|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271203|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271204|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271205|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271206|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271207|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271208|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271209|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271210|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271211|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271212|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271213|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271214|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271215|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271216|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271217|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271218|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271219|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271220|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271221|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271222|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271223|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271224|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271225|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271226|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271227|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271228|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271229|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271230|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271231|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271232|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271233|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271234|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271235|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271236|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271237|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271238|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271239|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271240|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271241|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271242|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271243|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271244|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271245|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271246|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271247|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271248|NCT00056407|E2|Reported Event|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
271249|NCT00056407|E1|Reported Event|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
271250|NCT00056472|B3|Baseline|Total|Total of all reporting groups
271251|NCT00056472|B2|Baseline|Monotherapy|placebo plus olanzapine
271252|NCT00056472|B1|Baseline|Pharmacotherapy|sertraline plus olanzapine
271253|NCT00056472|P2|Participant Flow|Olanzapine Plus Placebo|5-20mg/day olanzapine plus placebo
271254|NCT00056472|P1|Participant Flow|Sertraline Plus Olanzapine|50-200mg/day sertraline plus 5-20mg/day olanzapine
271255|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
271256|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
271257|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
271258|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
271259|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
271260|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
271261|NCT00056472|E2|Reported Event|Monotherapy|placebo plus olanzapine
271262|NCT00056472|E1|Reported Event|Pharmacotherapy|sertraline plus olanzapine
271263|NCT00056498|B3|Baseline|Total|Total of all reporting groups
271264|NCT00056498|B2|Baseline|Placebo|Participants assigned to placebo
271265|NCT00056498|B1|Baseline|Risperidone|Participants assigned to risperidone
271266|NCT00056498|P2|Participant Flow|Placebo|Participants assigned to placebo
271267|NCT00056498|P1|Participant Flow|Risperidone|Participants assigned to risperidone
271268|NCT00056498|O2|Outcome|Placebo|Participants assigned to placebo
271269|NCT00056498|O1|Outcome|Risperidone|Participants assigned to risperidone
271270|NCT00056498|E2|Reported Event|Placebo|Participants assigned to placebo
271271|NCT00056498|E1|Reported Event|Risperidone|Participants assigned to risperidone
271272|NCT00056550|B1|Baseline|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal.
271273|NCT00056550|P1|Participant Flow|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary antithrombin(AT)deficient patients scheduled for surgery, cesarean section or vaginal delivery were planned to be treated prophylactically with recombinant human antithrombin (rhAT). Dosing with recombinant human antithrombin (rhAT) was individualized with an initial intravenous loading dose, followed by a continuous intravenous infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at >80% and <120% of normal during the high risk period for thromboembolic events. Dosing and dose adjustments were based on the results of AT activity level determinations performed prior to and during the treatment.
271274|NCT00056550|O1|Outcome|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal.
271275|NCT00056550|O1|Outcome|Recombinant Human Antithombin (rhAT) Infusion|Following a baseline evaluation phase hereditary antithrombin (AT) deficient patients scheduled for surgery, cesarean section or vaginal delivery were planned to be treated prophylactically with recombinant human antithrombin (rhAT). Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at >80 and < 120% of normal during the high risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
271276|NCT00056550|E1|Reported Event|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal.
271277|NCT00056563|B3|Baseline|Total|Total of all reporting groups
271278|NCT00056563|B2|Baseline|2: Best Medical Therapy|"Best Medical Therapy
best medical therapy : Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
271457|NCT00057941|E2|Reported Event|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
271279|NCT00056563|B1|Baseline|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
271280|NCT00056563|P2|Participant Flow|2: Best Medical Therapy|"Best Medical Therapy
best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
271281|NCT00056563|P1|Participant Flow|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
271282|NCT00056563|O2|Outcome|2: Best Medical Therapy|"Best Medical Therapy
best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
271283|NCT00056563|O1|Outcome|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
271284|NCT00056563|O2|Outcome|2: Best Medical Therapy|"Best Medical Therapy
best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
271285|NCT00056563|O1|Outcome|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
271286|NCT00056563|E2|Reported Event|2: Best Medical Therapy|"Best Medical Therapy
best medical therapy : Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
271287|NCT00056563|E1|Reported Event|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
271288|NCT00056862|B3|Baseline|Total|Total of all reporting groups
271289|NCT00056862|B2|Baseline|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
271290|NCT00056862|B1|Baseline|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
271291|NCT00056862|P2|Participant Flow|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
271292|NCT00056862|P1|Participant Flow|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
271293|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
271294|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
271295|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
271296|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
271297|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
271298|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
271299|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
271300|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
271408|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
271301|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
271302|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
271303|NCT00056862|E2|Reported Event|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
271304|NCT00056862|E1|Reported Event|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
271305|NCT00057330|B3|Baseline|Total|Total of all reporting groups
271306|NCT00057330|B2|Baseline|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271307|NCT00057330|B1|Baseline|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271308|NCT00057330|P2|Participant Flow|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271309|NCT00057330|P1|Participant Flow|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271310|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271311|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271312|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271313|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271314|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271315|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271316|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271317|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271318|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271319|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271320|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271321|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271322|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271323|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271324|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271325|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271610|NCT00049842|E1|Reported Event|PEG-Intron|
271326|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271327|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271328|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271329|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271330|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271331|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271332|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271333|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271334|NCT00057330|E2|Reported Event|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271335|NCT00057330|E1|Reported Event|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
271336|NCT00057551|B4|Baseline|Total|Total of all reporting groups
271337|NCT00057551|B3|Baseline|Medication Only|"Sertraline
Escitalopram
Bupropion SR or XL
Venlafaxine XR
Mirtazapine"
271338|NCT00057551|B2|Baseline|Brief Supportive P|Brief Supportive Psychotherapyherapy
271339|NCT00057551|B1|Baseline|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
271340|NCT00057551|P3|Participant Flow|Medication Only|"An algorithm including Sertraline, Escitalopram
Bupropion SR or XL
Venlafaxine XR
Mirtazapine"
271341|NCT00057551|P2|Participant Flow|Brief Supportive Psychotherapy|Brief Supportive Psychotherapyherapy
271342|NCT00057551|P1|Participant Flow|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
271343|NCT00057551|O3|Outcome|Medication Only|"Sertraline
Escitalopram
Bupropion SR or XL
Venlafaxine XR
Mirtazapine"
271344|NCT00057551|O2|Outcome|Brief SP|Supportive Therapy
271345|NCT00057551|O1|Outcome|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
271346|NCT00057551|E3|Reported Event|Medication|"Sertraline
Escitalopram
Bupropion SR or XL
Venlafaxine XR
Mirtazapine"
271347|NCT00057551|E2|Reported Event|BriefSP|Supportive Therapy
271348|NCT00057551|E1|Reported Event|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
271349|NCT00057577|B3|Baseline|Total|Total of all reporting groups
271350|NCT00057577|B2|Baseline|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271351|NCT00057577|B1|Baseline|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271352|NCT00057577|P2|Participant Flow|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271378|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
271407|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
271353|NCT00057577|P1|Participant Flow|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271354|NCT00057577|O2|Outcome|Antidepressant Medications Only|"Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271355|NCT00057577|O1|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271356|NCT00057577|O4|Outcome|Prior Meds Withdrawn|Patients who recovered on medication treatment were withdrawn from medications
271357|NCT00057577|O3|Outcome|Prioir Meds Maintained|Patients who recovered on medication treatment were maintained on medications
271358|NCT00057577|O2|Outcome|Prior CBT + Meds Withdrawn|Patients who recovered on combined treatment (CBT + Meds) were phased out of cognitive therapy and withdrawn from medications
271359|NCT00057577|O1|Outcome|Prior CBT + Meds Maintained|Patients who recovered on combined treatment (CBT + Meds) were phased out of cognitive therapy and maintained on medications
271360|NCT00057577|O2|Outcome|Antidepressant Medications Only|"Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271361|NCT00057577|O1|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271362|NCT00057577|O2|Outcome|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271363|NCT00057577|O1|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271364|NCT00057577|E2|Reported Event|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271453|NCT00057941|P2|Participant Flow|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
271365|NCT00057577|E1|Reported Event|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
271366|NCT00057681|B4|Baseline|Total|Total of all reporting groups
271367|NCT00057681|B3|Baseline|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
271368|NCT00057681|B2|Baseline|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
271369|NCT00057681|B1|Baseline|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
271370|NCT00057681|P3|Participant Flow|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
271371|NCT00057681|P2|Participant Flow|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
271372|NCT00057681|P1|Participant Flow|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
271373|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
271374|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
271375|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
271376|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
271377|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
271406|NCT00057811|P1|Participant Flow|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
271379|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
271380|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
271381|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
271382|NCT00057681|E3|Reported Event|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
271383|NCT00057681|E2|Reported Event|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
271384|NCT00057681|E1|Reported Event|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
271385|NCT00057746|B4|Baseline|Total|Total of all reporting groups
271386|NCT00057746|B3|Baseline|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
271387|NCT00057746|B2|Baseline|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
271388|NCT00057746|B1|Baseline|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
271389|NCT00057746|P3|Participant Flow|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
271390|NCT00057746|P2|Participant Flow|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
271391|NCT00057746|P1|Participant Flow|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
271392|NCT00057746|O3|Outcome|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
271393|NCT00057746|O2|Outcome|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
271394|NCT00057746|O1|Outcome|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
271395|NCT00057746|E3|Reported Event|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
271396|NCT00057746|E2|Reported Event|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
271397|NCT00057746|E1|Reported Event|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
271398|NCT00057785|B1|Baseline|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
271399|NCT00057785|P1|Participant Flow|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
271400|NCT00057785|O1|Outcome|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
271401|NCT00057785|E1|Reported Event|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
271402|NCT00057811|B3|Baseline|Total|Total of all reporting groups
271403|NCT00057811|B2|Baseline|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
271404|NCT00057811|B1|Baseline|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
271405|NCT00057811|P2|Participant Flow|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
271409|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
271410|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
271411|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
271412|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
271413|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
271414|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
271415|NCT00057811|E2|Reported Event|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
271416|NCT00057811|E1|Reported Event|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
271417|NCT00057837|B3|Baseline|Total|Total of all reporting groups
271418|NCT00057837|B2|Baseline|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
271419|NCT00057837|B1|Baseline|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
271420|NCT00057837|P2|Participant Flow|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
271421|NCT00057837|P1|Participant Flow|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
271422|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
271423|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
271424|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
271425|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
271426|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
271427|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
271428|NCT00057837|E2|Reported Event|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
271429|NCT00057837|E1|Reported Event|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
271430|NCT00057863|B1|Baseline|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Oxaliplatin: Given IV"
271431|NCT00057863|P1|Participant Flow|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Oxaliplatin: Given IV"
271432|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Oxaliplatin: Given IV"
271433|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Oxaliplatin: Given IV"
271434|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Oxaliplatin: Given IV"
271435|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Oxaliplatin: Given IV"
271454|NCT00057941|P1|Participant Flow|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
271455|NCT00057941|O2|Outcome|Fulvestrant and ZD1839|
271436|NCT00057863|E1|Reported Event|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Oxaliplatin: Given IV"
271437|NCT00057876|B3|Baseline|Total|Total of all reporting groups
271438|NCT00057876|B2|Baseline|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
271439|NCT00057876|B1|Baseline|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
271440|NCT00057876|P2|Participant Flow|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
271441|NCT00057876|P1|Participant Flow|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
271442|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
271443|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
271444|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
271445|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
271446|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
271447|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
271448|NCT00057876|E2|Reported Event|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
271449|NCT00057876|E1|Reported Event|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
271450|NCT00057941|B3|Baseline|Total|Total of all reporting groups
271451|NCT00057941|B2|Baseline|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
271452|NCT00057941|B1|Baseline|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
271458|NCT00057941|E1|Reported Event|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
271459|NCT00057954|B1|Baseline|Transplant|Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
271460|NCT00057954|P1|Participant Flow|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
271461|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
271462|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
271463|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
271464|NCT00057954|E1|Reported Event|Transplant|Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
271465|NCT00058019|B3|Baseline|Total|Total of all reporting groups
271466|NCT00058019|B2|Baseline|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
271467|NCT00058019|B1|Baseline|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
271468|NCT00058019|P2|Participant Flow|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
271469|NCT00058019|P1|Participant Flow|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
271470|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
271471|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
271472|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
271473|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
271474|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
271475|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
271476|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
271477|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
271478|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
271479|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
271480|NCT00058019|E1|Reported Event|Ixabeilone for Relapsed Aggressive NHL|
271481|NCT00058214|B1|Baseline|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.
perifosine: Given orally
laboratory biomarker analysis: Correlative studies"
271482|NCT00058214|P1|Participant Flow|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.
perifosine: Given orally
laboratory biomarker analysis: Correlative studies"
271483|NCT00058214|O1|Outcome|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.
perifosine: Given orally
laboratory biomarker analysis: Correlative studies"
271611|NCT00050011|B3|Baseline|Total|Total of all reporting groups
271653|NCT00050089|O2|Outcome|Mega-ART|This includes participants randomized to Mega-ART (No ARDFP+Mega-ART or ARDFP+Mega-ART)
271484|NCT00058214|O1|Outcome|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.
perifosine: Given orally
laboratory biomarker analysis: Correlative studies"
271485|NCT00058214|E1|Reported Event|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.
perifosine: Given orally
laboratory biomarker analysis: Correlative studies"
271486|NCT00058240|B5|Baseline|Total|Total of all reporting groups
271487|NCT00058240|B4|Baseline|Dose Level 4|Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
271488|NCT00058240|B3|Baseline|Dose Level 3|Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
271489|NCT00058240|B2|Baseline|Dose Level 2|Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles.
271490|NCT00058240|B1|Baseline|Dose Level 1|Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
271491|NCT00058240|P4|Participant Flow|Dose Level 4|Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
271492|NCT00058240|P3|Participant Flow|Dose Level 3|Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
271493|NCT00058240|P2|Participant Flow|Dose Level 2|Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
271494|NCT00058240|P1|Participant Flow|Dose Level 1|Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
271495|NCT00058240|O1|Outcome|Dose Level 1, 2, 3, 4|"Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles.
Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles"
271496|NCT00058240|O1|Outcome|Dose Level 4|Flavopiridol was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour beginning Dose Level 2 Cycle 1 for 6 Cycles.
271497|NCT00058240|O4|Outcome|Dose Level 4|Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
271498|NCT00058240|O3|Outcome|Dose Level 3|Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
271499|NCT00058240|O2|Outcome|Dose Level 2|Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
271500|NCT00058240|O1|Outcome|Dose Level 1|Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
271501|NCT00058240|E2|Reported Event|Dose Level 4|Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
271502|NCT00058240|E1|Reported Event|Dose Levels 1-3|"Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles"
271503|NCT00058539|B1|Baseline|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
271504|NCT00058539|P1|Participant Flow|Pertuzumab|All the participants received a loading dose of 840 milligrams (mg) of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an intravenous (IV) infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
271644|NCT00050089|O1|Outcome|ARDFP|This includes participants randomized to ARDFP (ARDFP+Standard-ART or ARDFP+Mega-ART)
271505|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
271506|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
271507|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
271508|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
271509|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
271510|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
271511|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
271512|NCT00058539|E1|Reported Event|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
271513|NCT00058552|B3|Baseline|Total|Total of all reporting groups
271514|NCT00058552|B2|Baseline|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
271515|NCT00058552|B1|Baseline|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
271516|NCT00058552|P2|Participant Flow|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
271517|NCT00058552|P1|Participant Flow|Pertuzumab 420 mg|Participants in this group received pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for Cycle 1 (1 Cycle equals to [=] 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
271518|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
271519|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab at a loading dose of 840 mg for Cycle 1, followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression (1 Cycle = 3 Weeks).
271520|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
271521|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
271522|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
271523|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
271524|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
271645|NCT00050089|O2|Outcome|Mega-ART|This includes participants randomized to Mega-ART (No ARDFP+Mega-ART or ARDFP+Mega-ART)
271525|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
271526|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
271527|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
271528|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
271529|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
271530|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
271531|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
271532|NCT00058552|E2|Reported Event|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
271533|NCT00058552|E1|Reported Event|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
271534|NCT00049322|B3|Baseline|Total|Total of all reporting groups
271535|NCT00049322|B2|Baseline|Arm II (TACE-O Arm )|Observation
271536|NCT00049322|B1|Baseline|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
271537|NCT00049322|P2|Participant Flow|Arm II (TACE-O Arm )|Observation
271538|NCT00049322|P1|Participant Flow|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
271539|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
271540|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
271541|NCT00049322|O2|Outcome|Arm II-chemoembolization|chemoembolization as part of standard of care
271542|NCT00049322|O1|Outcome|Arm I-bevacizumab|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
271543|NCT00049322|O2|Outcome|Arm II (TACE-O Arm )|Observation
271544|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
271545|NCT00049322|O2|Outcome|Arm II (TACE-O Arm )|Observation
271546|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
271547|NCT00049322|E2|Reported Event|Arm II|Patients do not receive bevacizumab
271548|NCT00049322|E1|Reported Event|Arm I|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
271646|NCT00050089|O1|Outcome|Standard-ART|This includes participants randomized to Standard-ART (No ARDFP+Standard-ART or ARDFP+Standard-ART)
271647|NCT00050089|O4|Outcome|ARDFP + Mega ART|Intensive ART following ART interruption
271648|NCT00050089|O3|Outcome|ARDFP + Standard ART|Standard ART regimen following ART interruption
315933|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
271549|NCT00049504|B1|Baseline|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
271550|NCT00049504|P1|Participant Flow|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
271551|NCT00049504|O1|Outcome|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
271552|NCT00049504|O1|Outcome|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
271553|NCT00049504|O1|Outcome|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
271554|NCT00049504|E1|Reported Event|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
271555|NCT00049517|B3|Baseline|Total|Total of all reporting groups
271556|NCT00049517|B2|Baseline|High Dose Daunorubicin (Induction Therapy)|Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.
271557|NCT00049517|B1|Baseline|Standard Daunorubicin (Induction Therapy)|"Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.
Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course."
271558|NCT00049517|P6|Participant Flow|High-dose Daunorubicin Then Allogeneic HCT or no Consolidation|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available."
271559|NCT00049517|P5|Participant Flow|Standard Daunorubicin Then Allogeneic HCT or no Consolidation|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available."
271560|NCT00049517|P4|Participant Flow|High-dose Daunorubicin Then GO/Autologous HCT|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.
The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
271649|NCT00050089|O2|Outcome|No ARDFP + Mega ART|Intensive ART regimen, with no prior ART interruption
315934|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
271561|NCT00049517|P3|Participant Flow|Standard Daunorubicin Then GO/Autologous HCT|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.
The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
271562|NCT00049517|P2|Participant Flow|High-dose Daunorubicin Then Autologous HCT|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.
The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
271563|NCT00049517|P1|Participant Flow|Standard Daunorubicin Then Autologous HCT|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Consolidation/Transplant:
Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.
The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
271564|NCT00049517|O2|Outcome|Go/Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
271565|NCT00049517|O1|Outcome|Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
271566|NCT00049517|O2|Outcome|Go/Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
271567|NCT00049517|O1|Outcome|Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
271568|NCT00049517|O2|Outcome|High-dose Daunorubicin|Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
271569|NCT00049517|O1|Outcome|Standard Daunorubicin|Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
271570|NCT00049517|E2|Reported Event|High Dose Daunorubicin (Induction Therapy)|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.
Conditioning/Transplant:
Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I."
271571|NCT00049517|E1|Reported Event|Standard Daunorubicin (Induction Therapy)|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.
Conditioning/Transplant:
Patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive sargramostim (GM-CSF) or filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 0 and continuing until blood counts recover."
271572|NCT00049530|B1|Baseline|PEG-Interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
271573|NCT00049530|P1|Participant Flow|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
271574|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
271575|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
271576|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
271577|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
271578|NCT00049530|E1|Reported Event|PEG-Interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
271579|NCT00049543|B3|Baseline|Total|Total of all reporting groups
271580|NCT00049543|B2|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
271581|NCT00049543|B1|Baseline|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies"
271582|NCT00049543|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
271583|NCT00049543|P1|Participant Flow|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies"
271584|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
271585|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies"
271586|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
271587|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies"
271588|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
271589|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies"
271590|NCT00049543|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
271591|NCT00049543|E1|Reported Event|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies"
271592|NCT00049842|B3|Baseline|Total|Total of all reporting groups
271593|NCT00049842|B2|Baseline|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
271594|NCT00049842|B1|Baseline|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
271595|NCT00049842|P2|Participant Flow|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
271596|NCT00049842|P1|Participant Flow|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
271597|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
271598|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
271599|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
271600|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
271601|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
271602|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
271603|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
271604|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
271605|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
271606|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
271607|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
271608|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
271609|NCT00049842|E2|Reported Event|Untreated Control|
271612|NCT00050011|B2|Baseline|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid upfront 4 mg IV 15-minute infusion every 6 months."
271613|NCT00050011|B1|Baseline|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid upfront 4 mg IV 15-minute infusion every 6 months."
271614|NCT00050011|P2|Participant Flow|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic acid 4 mg IV 15-minute infusion every 6 months."
271615|NCT00050011|P1|Participant Flow|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence) or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271616|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271617|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271618|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271619|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271620|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271621|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271622|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271623|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271650|NCT00050089|O1|Outcome|No ARDFP + Standard ART|Standard ART regimen, with no prior ART interruption
271651|NCT00050089|O2|Outcome|No ARDFP|This includes participants randomized to No ARDFP (No ARDFP+Standard-ART or No ARDFP+Mega-ART)
271624|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271625|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271626|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271627|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271628|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271629|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271630|NCT00050011|O2|Outcome|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271631|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily.
Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271632|NCT00050011|E2|Reported Event|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily. Zoledronic Acid : Participants received Zoledronic acid 4 mg IV 15-minute infusion every 6 months."
271633|NCT00050011|E1|Reported Event|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Femara 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Letrozole : Participants received 2.5 mg daily. Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
271634|NCT00050089|B5|Baseline|Total|Total of all reporting groups
271635|NCT00050089|B4|Baseline|ARDFP + Mega ART|Antiretroviral Treatment Interruption and Intensive ART
271636|NCT00050089|B3|Baseline|ARDFP + Standard ART|Antiretroviral Treatment Interruption and Standard ART
271637|NCT00050089|B2|Baseline|No ARDFP + Mega ART|Intensive Antiretroviral Treatment regimen
271638|NCT00050089|B1|Baseline|No ARDFP + Standard ART|Standard Antiretroviral Treatment regimen
271639|NCT00050089|P4|Participant Flow|ARDFP+Mega-ART|"Antiretroviral Drug-Free Period (ARDFP) and Mega-ART
Intended duration of ARDFP: 12 weeks Mega-ART: 5 or more anti-HIV drugs"
271640|NCT00050089|P3|Participant Flow|ARDFP+Standard-ART|"Antiretroviral Drug-Free Period (ARDFP) and Standard-ART
Intended duration of ARDFP: 12 week2 Standard-ART: up to 4 anti-HIV drugs"
271641|NCT00050089|P2|Participant Flow|No ARDFP+Mega-ART|"No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART
Mega-ART: 5 or more anti-HIV drugs"
271642|NCT00050089|P1|Participant Flow|No ARDFP+Standard-ART|"No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART
Standard-ART: up to 4 anti-HIV drugs"
271643|NCT00050089|O2|Outcome|No ARDFP|This includes participants randomized to No ARDFP (No ARDFP+Standard-ART or No ARDFP+Mega-ART)
271654|NCT00050089|O1|Outcome|Standard-ART|This includes participants randomized to Standard-ART (No ARDFP+Standard-ART or ARDFP+Standard-ART)
271655|NCT00050089|E4|Reported Event|ARDFP + Mega ART|Antiretroviral Treatment Interruption and Intensive ART
271656|NCT00050089|E3|Reported Event|ARDFP + Standard ART|Antiretroviral Treatment Interruption and Standard ART
271657|NCT00050089|E2|Reported Event|No ARDFP + Mega ART|Intensive Antiretroviral Treatment regimen
271658|NCT00050089|E1|Reported Event|No ARDFP + Standard ART|Standard Antiretroviral Treatment regimen
271659|NCT00050167|B3|Baseline|Total|Total of all reporting groups
271660|NCT00050167|B2|Baseline|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
271661|NCT00050167|B1|Baseline|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
271662|NCT00050167|P2|Participant Flow|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
271663|NCT00050167|P1|Participant Flow|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
271664|NCT00050167|O2|Outcome|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
271665|NCT00050167|O1|Outcome|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
271666|NCT00050167|E2|Reported Event|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
271667|NCT00050167|E1|Reported Event|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
271668|NCT00050622|B1|Baseline|Within-Subject Treatment|All subjects completed a within-subjects crossover of 3 levels of behavior modification and 4 levels of medication.
271669|NCT00050622|P1|Participant Flow|Within-Subject Treatment|All subjects received a within-subjects crossover of 3 levels of behavior modification, randomized in 3-week units, and 4 levels of medication, randomized on a daily basis. Thus each participant experienced all 12 combinations of No, Low, and High Intensity BMOD crossed with Placebo, 0.15 mg/kg MPH, 0.3 mg/kg MPH, and 0.6 mg/kg MPH conditions, with specific conditions changing daily.
271670|NCT00050622|O6|Outcome|High Intensity BMOD + Medication|High Intensity BMOD + Medication (any dose)
271671|NCT00050622|O5|Outcome|Low Intensity BMOD + Med|Low intensity behavior modification + medication (any dose)
271672|NCT00050622|O4|Outcome|Medication Only|No BMOD + Medication (any dose)
271673|NCT00050622|O3|Outcome|High Intensity BMOD ONly|
271674|NCT00050622|O2|Outcome|Low Intensity BMOD Only|
271675|NCT00050622|O1|Outcome|No Treatment|No BMOD, No medication
271676|NCT00050622|O12|Outcome|High Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP"
271677|NCT00050622|O11|Outcome|High Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP"
271678|NCT00050622|O10|Outcome|High Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP"
271679|NCT00050622|O9|Outcome|High Intensity BMOD Only|"Placebo, High Intensity BMOD
High Intensity BMOD: Comprehensive high-intensity STP"
271680|NCT00050622|O8|Outcome|Low Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
271681|NCT00050622|O7|Outcome|Low Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
271682|NCT00050622|O6|Outcome|Low Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, Low Intensity BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
Low-Intensity BMOD: Lower-intensity behavioral treatment package."
271683|NCT00050622|O5|Outcome|Low Intensity BMOD Only|"Placebo, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Placebo"
271684|NCT00050622|O4|Outcome|Higher Dose Medication Only|"0.6 mg/kg MPH, No BMOD
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
271685|NCT00050622|O3|Outcome|Medium Dose Medication Only|"0.3 mg/kg MPH, No BMOD
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
271686|NCT00050622|O2|Outcome|Low Dose Medication Only|"0.15 mg/kg MPH, No BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate"
271687|NCT00050622|O1|Outcome|No Treatment|"No Medication, No BMOD
Placebo"
271688|NCT00050622|O12|Outcome|High Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP"
271689|NCT00050622|O11|Outcome|High Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP"
271690|NCT00050622|O10|Outcome|High Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP"
271691|NCT00050622|O9|Outcome|High Intensity BMOD Only|"Placebo, High Intensity BMOD
High Intensity BMOD: Comprehensive high-intensity STP"
271692|NCT00050622|O8|Outcome|Low Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
271693|NCT00050622|O7|Outcome|Low Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
271726|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
271694|NCT00050622|O6|Outcome|Low Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, Low Intensity BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
Low-Intensity BMOD: Lower-intensity behavioral treatment package."
271695|NCT00050622|O5|Outcome|Low Intensity BMOD Only|"Placebo, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Placebo"
271696|NCT00050622|O4|Outcome|Higher Dose Medication Only|"0.6 mg/kg MPH, No BMOD
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
271697|NCT00050622|O3|Outcome|Medium Dose Medication Only|"0.3 mg/kg MPH, No BMOD
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
271698|NCT00050622|O2|Outcome|Low Dose Medication Only|"0.15 mg/kg MPH, No BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate"
271699|NCT00050622|O1|Outcome|No Treatment|"No Medication, No BMOD
Placebo"
271700|NCT00050622|E4|Reported Event|Higher Dose Medication|0.6 mg/kg MPH, No BMOD
271701|NCT00050622|E3|Reported Event|Medium Dose Medication|0.3 mg/kg MPH, No BMOD
271702|NCT00050622|E2|Reported Event|Low Dose Medication|0.15 mg/kg MPH, No BMOD
271703|NCT00050622|E1|Reported Event|Placebo|Placebo
271704|NCT00050778|B4|Baseline|Total|Total of all reporting groups
271705|NCT00050778|B3|Baseline|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271706|NCT00050778|B2|Baseline|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271707|NCT00050778|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
271708|NCT00050778|P3|Participant Flow|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271709|NCT00050778|P2|Participant Flow|Alemtuzumab 12 mg|Alemtuzumab (Lemtrada™) 12 milligram per day (mg/day) was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the cluster of differentiation 4+ [CD4+] T-cell count was >=100*10^6 cells per liter).
271710|NCT00050778|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (Rebif®) 44 micrograms (mcg) subcutaneously 3-times weekly for 36 months.
271711|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271712|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271713|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271714|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
271715|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271716|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271717|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271718|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
271719|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271720|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271721|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271722|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
271723|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271724|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271725|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271727|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271728|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271729|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271730|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
271731|NCT00050778|E4|Reported Event|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271732|NCT00050778|E3|Reported Event|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271733|NCT00050778|E2|Reported Event|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
271734|NCT00050778|E1|Reported Event|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
271735|NCT00050960|B3|Baseline|Total|Total of all reporting groups
271736|NCT00050960|B2|Baseline|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
271737|NCT00050960|B1|Baseline|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
271738|NCT00050960|P2|Participant Flow|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
271739|NCT00050960|P1|Participant Flow|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
271740|NCT00050960|O2|Outcome|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
271741|NCT00050960|O1|Outcome|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
271742|NCT00050960|E2|Reported Event|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
271743|NCT00050960|E1|Reported Event|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
271744|NCT00050986|B1|Baseline|Temozolomide and R115777|
271745|NCT00050986|P1|Participant Flow|Temozolomide and R115777|
271746|NCT00050986|O1|Outcome|Temozolomide and R115777|
271747|NCT00050986|E1|Reported Event|Temozolomide and R115777|
271748|NCT00058825|B1|Baseline|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.
Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant: Day 0: Donor stem cells infused.
Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
271749|NCT00058825|P1|Participant Flow|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.
Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant: Day 0: Donor stem cells infused.
Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
271750|NCT00058825|O2|Outcome|CLINIMACs|The CLINIMACS CD34 Reagent system was used for cell selection.
271751|NCT00058825|O1|Outcome|Isolex|The Isolex system was used for cell selection.
271752|NCT00058825|O2|Outcome|CLINIMACs|The CLINIMACS CD34 Reagent system was used for cell selection.
271753|NCT00058825|O1|Outcome|Isolex|The Isolex system was used for cell selection.
271754|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.
Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant: Day 0: Donor stem cells infused.
Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
271755|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.
Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant: Day 0: Donor stem cells infused.
Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
271756|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.
Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant: Day 0: Donor stem cells infused.
Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
271757|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.
Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant: Day 0: Donor stem cells infused.
Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
271758|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.
Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant: Day 0: Donor stem cells infused.
Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
271759|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.
Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant: Day 0: Donor stem cells infused.
Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
271760|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.
Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant: Day 0: Donor stem cells infused.
Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
271761|NCT00058825|E1|Reported Event|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.
Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant: Day 0: Donor stem cells infused.
Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
271762|NCT00060333|B1|Baseline|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
271763|NCT00060333|P1|Participant Flow|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
271764|NCT00060333|O3|Outcome|Treatment (Adjuvant Radiation Therapy) Q03|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 3 (Q03) of the Brief Fatigue Inventory (BFI) which instructs “Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during the past 24 hours.”
271765|NCT00060333|O2|Outcome|Treatment (Adjuvant Radiation Therapy) Q02|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 2 (Q02) of the Brief Fatigue Inventory (BFI) which instructs “Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your USUAL level of fatigue during the past 24 hours.”
271766|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy) Q01|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 1 (Q01) of the Brief Fatigue Inventory (BFI) which instructs “Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your fatigue right NOW.”
271767|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
271768|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
271769|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
271770|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
271771|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
271772|NCT00060333|E1|Reported Event|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
271773|NCT00060346|B1|Baseline|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:
Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
271774|NCT00060346|P1|Participant Flow|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:
Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
271775|NCT00060346|O1|Outcome|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:
Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
271776|NCT00060346|E1|Reported Event|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:
Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
271777|NCT00060528|B1|Baseline|Prostate Cancer Patients|Progressive Metastatic Castration Resistant Prostate Cancer
271778|NCT00060528|P4|Participant Flow|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
271779|NCT00060528|P3|Participant Flow|rF-GM (10^7pfu)|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
271780|NCT00060528|P2|Participant Flow|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
271781|NCT00060528|P1|Participant Flow|no GM|Vaccine subcutaneously with no GM
271782|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8)with efficacy and immunological response as a primary endpoint.
271783|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8)with efficacy and immunological response as a primary endpoint.
271784|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8) with efficacy and immunological response as a primary endpoint.
271785|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms:e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8) with efficacy and immunological response as a primary endpoint.
271786|NCT00060528|O4|Outcome|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
271787|NCT00060528|O3|Outcome|rF-GM (10^7pfu),|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
271788|NCT00060528|O2|Outcome|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
271789|NCT00060528|O1|Outcome|No GM|Vaccine subcutaneously with no GM
271790|NCT00060528|E4|Reported Event|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
271791|NCT00060528|E3|Reported Event|rF-GM (10^7pfu)|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
271792|NCT00060528|E2|Reported Event|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
271793|NCT00060528|E1|Reported Event|no GM|Vaccine subcutaneously with no GM
271794|NCT00060840|B3|Baseline|Total|Total of all reporting groups
271795|NCT00060840|B2|Baseline|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
271796|NCT00060840|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
271797|NCT00060840|P2|Participant Flow|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
271798|NCT00060840|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
271799|NCT00060840|O2|Outcome|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
271800|NCT00060840|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
271801|NCT00060840|E2|Reported Event|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
271802|NCT00060840|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
271803|NCT00060944|B3|Baseline|Total|Total of all reporting groups
271804|NCT00060944|B2|Baseline|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
271805|NCT00060944|B1|Baseline|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
271806|NCT00060944|P2|Participant Flow|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
271807|NCT00060944|P1|Participant Flow|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
271808|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
271809|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
271810|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
271811|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
271812|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
271813|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
271814|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
271815|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
271816|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
271817|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
271818|NCT00060944|E2|Reported Event|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
271819|NCT00060944|E1|Reported Event|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
271820|NCT00061048|B1|Baseline|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
271821|NCT00061048|P1|Participant Flow|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
271822|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
271823|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
271824|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
271825|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
271826|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
271827|NCT00061048|E1|Reported Event|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
271828|NCT00061373|B3|Baseline|Total|Total of all reporting groups
271829|NCT00061373|B2|Baseline|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271830|NCT00061373|B1|Baseline|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271850|NCT00061633|P2|Participant Flow|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
315935|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
271831|NCT00061373|P2|Participant Flow|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271832|NCT00061373|P1|Participant Flow|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271833|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271834|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271835|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271836|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271837|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271838|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271839|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271840|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271841|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271842|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271843|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271844|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271845|NCT00061373|E2|Reported Event|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271846|NCT00061373|E1|Reported Event|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.
Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
271847|NCT00061633|B3|Baseline|Total|Total of all reporting groups
271848|NCT00061633|B2|Baseline|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
271849|NCT00061633|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
272786|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
271851|NCT00061633|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
271852|NCT00061633|O2|Outcome|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
271853|NCT00061633|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
271854|NCT00061633|E2|Reported Event|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
271855|NCT00061633|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
271856|NCT00061893|B1|Baseline|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
271857|NCT00061893|P1|Participant Flow|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
271858|NCT00061893|O1|Outcome|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
271859|NCT00061893|O1|Outcome|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
271860|NCT00061893|E1|Reported Event|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
271861|NCT00061932|B3|Baseline|Total|Total of all reporting groups
271862|NCT00061932|B2|Baseline|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
bortezomib: Given IV
irinotecan: Given IV"
271863|NCT00061932|B1|Baseline|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
bortezomib: Given IV
irinotecan: Given IV"
271864|NCT00061932|P2|Participant Flow|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
bortezomib: Given IV
irinotecan: Given IV"
271865|NCT00061932|P1|Participant Flow|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV 1.3 mg/m2 over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV 125 mg/m2 over 90 minutes on days 1 and 8.
bortezomib: Given IV (1.3 mg/m2)
irinotecan: Given IV (125 mg/m2)"
271866|NCT00061932|O2|Outcome|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
bortezomib: Given IV
irinotecan: Given IV"
271867|NCT00061932|O1|Outcome|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
bortezomib: Given IV
irinotecan: Given IV"
271868|NCT00061932|E2|Reported Event|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
bortezomib: Given IV
irinotecan: Given IV"
271869|NCT00061932|E1|Reported Event|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
bortezomib: Given IV
irinotecan: Given IV"
271870|NCT00061945|B3|Baseline|Total|Total of all reporting groups
271871|NCT00061945|B2|Baseline|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
271872|NCT00061945|B1|Baseline|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
271873|NCT00061945|P2|Participant Flow|Phase II - Alemtuzumab and Combination Chemotherapy|COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d 1,8,15 & 22, dexamethasone (DEX) PO 2x daily (BID) d 1-7 & 15-21, asparaginase (APG) subcutaneously (SC) d 5,8,11,15,18 & 22, and filgrastim (FIL) SC d 4-11. Ph+ pts imatinib (IMT) PO d 15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d 1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG & FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d 1,15 & 29, MTX IV & IT d 1,15 & 19, MTX PO q6 hr d 1-2,15-16 & 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 & 30, LCV PO q6 hr d 3-4 & CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d 1,8,15 & 22 and CRT PO BID 3x wkly. Ph+ pts IMT PO d1-28 q24 mo
271874|NCT00061945|P1|Participant Flow|Phase I - Alemtuzumab and Combination Chemotherapy|COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d1,8,15 & 22, dexamethasone (DEX) PO 2x daily (BID) d1-7 & 15-21, asparaginase (APG) subcutaneously (SC) d5,8,11,15,18 & 22, and filgrastim (FIL) SC d4-11. Ph+ pts imatinib (IMT) PO d15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG & FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d1,15 & 29, MTX IV & IT d1,15 & 19, MTX PO q6 hr d1-2,15-16 & 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 & 30, LCV PO q6 hr d3-4 & CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 10,20 or 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d1,8,15 & 22 and CRT PO BID 3d wkly. Ph+ pts IMT PO d1-28 q24 mo
271875|NCT00061945|O2|Outcome|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description
271876|NCT00061945|O1|Outcome|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description
271877|NCT00061945|O1|Outcome|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
271878|NCT00061945|O1|Outcome|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
271879|NCT00061945|E2|Reported Event|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
271880|NCT00061945|E1|Reported Event|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
271881|NCT00062010|B1|Baseline|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
271882|NCT00062010|P1|Participant Flow|IFN Alpha, 13-Cis-RA, Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
271883|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
271884|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
271885|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
271886|NCT00062010|E1|Reported Event|IFN Alpha, 13-CRA, Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
271887|NCT00062374|B1|Baseline|Arm I|"Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.
irinotecan hydrochloride: Given IV
cisplatin: Given IV
conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection
positron emission tomography/computed tomography: Undergo FDG-PET/CT
fludeoxyglucose F 18: Undergo FDG-PET/CT
positron emission tomography/computed tomography: Undergo FLT-PET/CT
fluorine F 18 fluorothymidine: Undergo FLT-PET/CT"
271888|NCT00062374|P1|Participant Flow|Arm I|Cisplatin + Irinotecan
271889|NCT00062374|O1|Outcome|Arm I|"Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.
irinotecan hydrochloride: Given IV
cisplatin: Given IV
conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection
positron emission tomography/computed tomography: Undergo FDG-PET/CT
fludeoxyglucose F 18: Undergo FDG-PET/CT
positron emission tomography/computed tomography: Undergo FLT-PET/CT
fluorine F 18 fluorothymidine: Undergo FLT-PET/CT"
271890|NCT00062374|O1|Outcome|Arm I|"Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.
irinotecan hydrochloride: Given IV
cisplatin: Given IV
conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection
positron emission tomography/computed tomography: Undergo FDG-PET/CT
fludeoxyglucose F 18: Undergo FDG-PET/CT
positron emission tomography/computed tomography: Undergo FLT-PET/CT
fluorine F 18 fluorothymidine: Undergo FLT-PET/CT"
271891|NCT00062374|E1|Reported Event|Arm I|"Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.
irinotecan hydrochloride: Given IV
cisplatin: Given IV
conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection
positron emission tomography/computed tomography: Undergo FDG-PET/CT
fludeoxyglucose F 18: Undergo FDG-PET/CT
positron emission tomography/computed tomography: Undergo FLT-PET/CT
fluorine F 18 fluorothymidine: Undergo FLT-PET/CT"
271892|NCT00062439|B1|Baseline|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
271893|NCT00062439|P1|Participant Flow|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
271894|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
271895|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
271896|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
271897|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
271898|NCT00062439|O3|Outcome|Consolidation Docetaxel|
271899|NCT00062439|O2|Outcome|Surgery|
271900|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT|
271901|NCT00062439|E3|Reported Event|Consolidation Docetaxel|
271902|NCT00062439|E2|Reported Event|Surgery|
271903|NCT00062439|E1|Reported Event|Induction Cisplatin/Etoposide + XRT|
271904|NCT00062647|B3|Baseline|Total|Total of all reporting groups
271905|NCT00062647|B2|Baseline|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
271906|NCT00062647|B1|Baseline|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
271907|NCT00062647|P2|Participant Flow|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
271908|NCT00062647|P1|Participant Flow|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
271909|NCT00062647|O2|Outcome|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
271910|NCT00062647|O1|Outcome|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
271911|NCT00062647|E2|Reported Event|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
271912|NCT00062647|E1|Reported Event|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
271913|NCT00062738|B4|Baseline|Total|Total of all reporting groups
271914|NCT00062738|B3|Baseline|Placebo|Placebo was started at 1 pill and could be increased up to three pills.
271915|NCT00062738|B2|Baseline|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
271916|NCT00062738|B1|Baseline|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
271917|NCT00062738|P3|Participant Flow|Placebo|Placebo was started at 1 pill and could be increased up to three pills, based on investigator discretion.
271918|NCT00062738|P2|Participant Flow|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg, based on investigator discretion. .
271919|NCT00062738|P1|Participant Flow|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
271920|NCT00062738|O3|Outcome|Placebo|Placebo was started at 1 pill and could be increased up to three pills.
271921|NCT00062738|O2|Outcome|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
272787|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
271922|NCT00062738|O1|Outcome|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
271923|NCT00062738|O3|Outcome|Placebo|
271924|NCT00062738|O2|Outcome|Paroxetine|
271925|NCT00062738|O1|Outcome|Nortriptyline|
271926|NCT00062738|E3|Reported Event|Placebo|
271927|NCT00062738|E2|Reported Event|Paroxetine|
271928|NCT00062738|E1|Reported Event|Nortriptyline|
271929|NCT00062751|B6|Baseline|Total|Total of all reporting groups
271930|NCT00062751|B5|Baseline|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271931|NCT00062751|B4|Baseline|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271932|NCT00062751|B3|Baseline|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271933|NCT00062751|B2|Baseline|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271934|NCT00062751|B1|Baseline|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271935|NCT00062751|P5|Participant Flow|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271936|NCT00062751|P4|Participant Flow|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271937|NCT00062751|P3|Participant Flow|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271938|NCT00062751|P2|Participant Flow|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271939|NCT00062751|P1|Participant Flow|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271940|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271941|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271942|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271943|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271944|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271945|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271946|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271947|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271948|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271949|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271950|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271951|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271952|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271953|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271954|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271955|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271956|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271957|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271958|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271959|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
272079|NCT00054665|O1|Outcome|Part A: PS-341 Alone|1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
271960|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271961|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271962|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271963|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271964|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271965|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271966|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271967|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271968|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271969|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271970|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271971|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271972|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271973|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271974|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271975|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271976|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271977|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271978|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271979|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271980|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271981|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271982|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271983|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271984|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271985|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271986|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271987|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271988|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271989|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271990|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271991|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271992|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271993|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
272096|NCT00054717|B3|Baseline|Total|Total of all reporting groups
271994|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
271995|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271996|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
271997|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271998|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
271999|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
272000|NCT00062751|E6|Reported Event|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
272001|NCT00062751|E5|Reported Event|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
272002|NCT00062751|E4|Reported Event|After Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779). Includes events reported after the cross-over date for cross-over participants.
272003|NCT00062751|E3|Reported Event|Let 2.5 mg Alone Prior to Cross-over to 75 mg Intermit CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent (intermit)75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). Includes events reported prior to the cross-over date for cross-over participants.
272004|NCT00062751|E2|Reported Event|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
272005|NCT00062751|E1|Reported Event|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
272006|NCT00062764|B1|Baseline|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
272007|NCT00062764|P1|Participant Flow|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
272008|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
272009|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
272010|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
272011|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
272012|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
272013|NCT00062764|E1|Reported Event|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
272014|NCT00054275|B1|Baseline|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
272015|NCT00054275|P1|Participant Flow|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
272016|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
272017|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
272018|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
272019|NCT00054275|E1|Reported Event|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
272020|NCT00054327|B7|Baseline|Total|Total of all reporting groups
272021|NCT00054327|B6|Baseline|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
272022|NCT00054327|B5|Baseline|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
272023|NCT00054327|B4|Baseline|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
272024|NCT00054327|B3|Baseline|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
272025|NCT00054327|B2|Baseline|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY.
272140|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272026|NCT00054327|B1|Baseline|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
272027|NCT00054327|P6|Participant Flow|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
272028|NCT00054327|P5|Participant Flow|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
272029|NCT00054327|P4|Participant Flow|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
272030|NCT00054327|P3|Participant Flow|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
272031|NCT00054327|P2|Participant Flow|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
272032|NCT00054327|P1|Participant Flow|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
272033|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
272034|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
272035|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
272036|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
272037|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
272038|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
272039|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
272040|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
272041|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
272042|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
272043|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
272044|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
272045|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
272046|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
272047|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
272048|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
272049|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
272050|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
272051|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
272052|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
272053|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
272054|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
272055|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
272056|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
272184|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272057|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
272058|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
272059|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
272060|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
272061|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
272062|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
272063|NCT00054327|E6|Reported Event|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
272064|NCT00054327|E5|Reported Event|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
272065|NCT00054327|E4|Reported Event|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
272066|NCT00054327|E3|Reported Event|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
272067|NCT00054327|E2|Reported Event|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
272068|NCT00054327|E1|Reported Event|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
272069|NCT00054639|B1|Baseline|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
272070|NCT00054639|P1|Participant Flow|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
272071|NCT00054639|O1|Outcome|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
272072|NCT00054639|E1|Reported Event|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
272073|NCT00054665|B1|Baseline|Arm A & B: PS-341 and PS-341 & EPOCH|"Part A: PS-341 Alone
1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks Part B: PS-341 & EPOCH
PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.
EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days"
272074|NCT00054665|P2|Participant Flow|Part B: PS-341 & EPOCH|PS-341 1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks. EPOCH (etoposide 50 mg/m^2 day continuous intravenous infusion days 1-4, doxorubicin 10 mg/m^2 day continuous intravenous infusion days 1-4, vincristine 0.4 mg/m^2/day continuous intravenous infusion days 1-4, cyclophosphamide 750 mg/m^2 intravenous bolus day 5, prednisone 60 mg/m^2 by mouth days 1-5, and filgrastim 300 micrograms subcutaneously day 6 to absolute neutrophil count (ANC) recovery >/= 5000/mm^3.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
272075|NCT00054665|P1|Participant Flow|Part A: PS-341 Alone|1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
272076|NCT00054665|O2|Outcome|Part B: PS-341 & EPOCH|"Part B:
PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.
EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days."
272077|NCT00054665|O1|Outcome|Part A: PS-341 Alone|Part A: 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
272078|NCT00054665|O2|Outcome|Part B: PS-341 & EPOCH|"PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.
EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days."
272080|NCT00054665|E2|Reported Event|Part B: PS-341 & EPOCH|"PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.
EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days."
272081|NCT00054665|E1|Reported Event|Part A: PS-341 Alone|PS-341 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
272082|NCT00054691|B1|Baseline|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
272083|NCT00054691|P1|Participant Flow|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
272084|NCT00054691|O1|Outcome|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
272085|NCT00054691|O1|Outcome|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
272086|NCT00054691|E1|Reported Event|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
272087|NCT00054704|B3|Baseline|Total|Total of all reporting groups
272088|NCT00054704|B2|Baseline|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
272089|NCT00054704|B1|Baseline|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
272090|NCT00054704|P2|Participant Flow|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
272091|NCT00054704|P1|Participant Flow|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
272092|NCT00054704|O2|Outcome|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
272093|NCT00054704|O1|Outcome|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
272094|NCT00054704|E2|Reported Event|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
272095|NCT00054704|E1|Reported Event|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
272097|NCT00054717|B2|Baseline|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272098|NCT00054717|B1|Baseline|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272099|NCT00054717|P2|Participant Flow|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272100|NCT00054717|P1|Participant Flow|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272101|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272102|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272103|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272104|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272105|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272106|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272107|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272108|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272109|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272110|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272111|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272112|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272113|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272114|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272115|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272116|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272117|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272118|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272119|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272120|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272121|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272122|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272123|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272124|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272125|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272126|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272127|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272128|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272129|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272130|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272131|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272132|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272133|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272134|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272135|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272136|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272137|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272138|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272139|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272141|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272142|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272143|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272144|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272145|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272146|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272147|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272148|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272149|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272150|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272151|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272152|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272153|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272154|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272155|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272156|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272157|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272158|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272159|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272160|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272161|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272162|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272163|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272164|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272165|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272166|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272167|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272168|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272169|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272170|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272171|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272172|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272173|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272174|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272175|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272176|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272177|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272178|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272179|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272180|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272181|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272182|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272183|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272185|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272186|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272187|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272188|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272189|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272190|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272191|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272192|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272193|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272194|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272195|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272196|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272197|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272198|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272199|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272200|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272201|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272202|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272203|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272204|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272205|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272206|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272207|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272208|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272209|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272210|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272211|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272212|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272213|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272214|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272215|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272216|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272217|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272218|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272219|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272220|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272221|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272222|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272223|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272224|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272225|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272226|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272227|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272228|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272229|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272230|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272231|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272232|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272233|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272234|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272235|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272236|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272237|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272238|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272239|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272240|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272241|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272242|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272243|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272244|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272245|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272246|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272247|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272248|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272249|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272250|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272251|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272252|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272253|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272254|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272255|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272256|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272257|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272258|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272259|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272260|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272261|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272262|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272263|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272264|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272265|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272266|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272267|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272268|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272269|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272270|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272788|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272271|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272272|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272273|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272274|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272275|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272276|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272277|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272278|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272279|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272280|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272281|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272282|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272283|NCT00054717|E2|Reported Event|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
272284|NCT00054717|E1|Reported Event|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
272285|NCT00054847|B3|Baseline|Total|Total of all reporting groups
272286|NCT00054847|B2|Baseline|Radial Artery Graft|"Radial Artery
radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
272287|NCT00054847|B1|Baseline|Saphenous Vein Graft|"Saphenous Vein Graft
saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
272288|NCT00054847|P2|Participant Flow|Radial Artery Graft|"Radial Artery Graft
radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
272289|NCT00054847|P1|Participant Flow|Saphenous Vein Graft|"Saphenous Vein Graft
saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
272290|NCT00054847|O2|Outcome|Arm 2|"Radial Artery
radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
272291|NCT00054847|O1|Outcome|Arm 1|"Saphenous Vein Graft
saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
272292|NCT00054847|O2|Outcome|Arm 2|"Radial Artery
radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
272293|NCT00054847|O1|Outcome|Arm 1|"Saphenous Vein Graft
saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
272294|NCT00054847|O2|Outcome|Radial Artery Grafts|"Radial Artery Grafts
radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
272295|NCT00054847|O1|Outcome|Saphenous Vein Graft|"Saphenous Vein Graft
saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
272296|NCT00054847|O2|Outcome|Radial Artery Graft|"Radial Artery
radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
272297|NCT00054847|O1|Outcome|Saphenous Vein Graft|"Saphenous Vein Graft
saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
272298|NCT00054847|E2|Reported Event|Arm 2|"Radial Artery
radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
272299|NCT00054847|E1|Reported Event|Arm 1|"Saphenous Vein Graft
saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
272300|NCT00055237|B3|Baseline|Total|Total of all reporting groups
272301|NCT00055237|B2|Baseline|Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
272302|NCT00055237|B1|Baseline|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
272303|NCT00055237|P2|Participant Flow|Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
272304|NCT00055237|P1|Participant Flow|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
272305|NCT00055237|O1|Outcome|Cohort 1 & 2: Pts With HIV-associated and Classic KS|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
272306|NCT00055237|O1|Outcome|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
272307|NCT00055237|E1|Reported Event|Cohort 1 & 2: Pts With HIV-associated and Classic KS|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
272308|NCT00055471|B4|Baseline|Total|Total of all reporting groups
272309|NCT00055471|B3|Baseline|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
272310|NCT00055471|B2|Baseline|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
272311|NCT00055471|B1|Baseline|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
272312|NCT00055471|P3|Participant Flow|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
272313|NCT00055471|P2|Participant Flow|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
272314|NCT00055471|P1|Participant Flow|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
272315|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
272316|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
272317|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
315936|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
272318|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
272319|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
272320|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
272321|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
272322|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
272323|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
272324|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
272325|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
272326|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
272327|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
272328|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
272329|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
272330|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
272331|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
272332|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
272333|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
272334|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
272335|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
272336|NCT00055471|E3|Reported Event|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
272337|NCT00055471|E2|Reported Event|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
272338|NCT00055471|E1|Reported Event|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
272339|NCT00055497|B5|Baseline|Total|Total of all reporting groups
272340|NCT00055497|B4|Baseline|OL Adalimumab 40 mg Eow|Participants who did not continue at Week 4 are not included in Baseline summary.
272341|NCT00055497|B3|Baseline|DB Adalimumab 40 mg Every Week|
272342|NCT00055497|B2|Baseline|DB Adalimumab 40 mg Every Other Week (Eow)|
272343|NCT00055497|B1|Baseline|DB Placebo|
272344|NCT00055497|P4|Participant Flow|OL Adalimumab 40 mg|Open-label adalimumab 40 mg every other week or every week.
272345|NCT00055497|P3|Participant Flow|DB Adalimumab 40 mg Every Week (ew)|Double-blind adalimumab 40 mg every week.
272346|NCT00055497|P2|Participant Flow|DB Adalimumab 40 mg Every Other Week (Eow)|Double-blind adalimumab 40 mg every other week (injection received every week; placebo received when active drug not received)
272347|NCT00055497|P1|Participant Flow|DB Placebo|Double-blind adalimumab placebo every week.
272348|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
272349|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
272350|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
272351|NCT00055497|O1|Outcome|DB Placebo|
272352|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
272353|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
272354|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
272355|NCT00055497|O1|Outcome|DB Placebo|
272356|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
272357|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
272358|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
272359|NCT00055497|O1|Outcome|DB Placebo|
272360|NCT00055497|O1|Outcome|OL Adalimumab 40 mg|
272361|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
272362|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
272363|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
272364|NCT00055497|O1|Outcome|DB Placebo|
272365|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
272366|NCT00055497|O3|Outcome|DB Adalimumab 40 mg ew|
272367|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Eow|
272368|NCT00055497|O1|Outcome|DB Placebo|
272369|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
272370|NCT00055497|O3|Outcome|DB Adalimumab 40 mg ew|
272371|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Eow|
272372|NCT00055497|O1|Outcome|DB Placebo|
272373|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
272374|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
272375|NCT00055497|O1|Outcome|DB Placebo|
272376|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
272377|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
272378|NCT00055497|O1|Outcome|Placebo|
272379|NCT00055497|O1|Outcome|OL Adalimumab 40 mg|Open-label adalimumab 40 mg every other week or every week
272380|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
272381|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
272382|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
272383|NCT00055497|O1|Outcome|DB Placebo|
272384|NCT00055497|E4|Reported Event|OL Adalimumab 40 mg|
272385|NCT00055497|E3|Reported Event|DB Adalimumab 40 mg ew|
272386|NCT00055497|E2|Reported Event|DB Adalimumab 40 mg Eow|
272387|NCT00055497|E1|Reported Event|DB Placebo|
272388|NCT00055601|B3|Baseline|Total|Total of all reporting groups
272389|NCT00055601|B2|Baseline|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272789|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
315937|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
272390|NCT00055601|B1|Baseline|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272391|NCT00055601|P2|Participant Flow|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272392|NCT00055601|P1|Participant Flow|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272393|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272394|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272395|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272396|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272397|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272398|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272399|NCT00055601|E2|Reported Event|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272400|NCT00055601|E1|Reported Event|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
272401|NCT00055692|B1|Baseline|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given orally"
272402|NCT00055692|P1|Participant Flow|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given orally"
272403|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given orally"
272404|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given orally"
272405|NCT00055692|O2|Outcome|Treatment (Bevacizumab): 8 Weeks|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given orally"
272406|NCT00055692|O1|Outcome|Treatment (Bevacizumab): Baseline|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given orally"
272407|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given orally"
272408|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given orally"
272409|NCT00055692|E1|Reported Event|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given orally"
272410|NCT00063154|B1|Baseline|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
272411|NCT00063154|P1|Participant Flow|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
272412|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
272413|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
272414|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
272415|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
272416|NCT00063154|E1|Reported Event|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
272417|NCT00063232|B1|Baseline|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
272418|NCT00063232|P1|Participant Flow|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
272419|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
272420|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
272421|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
272422|NCT00063232|E1|Reported Event|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
272423|NCT00063258|B3|Baseline|Total|Total of all reporting groups
272424|NCT00063258|B2|Baseline|Chemotherapy Alone|
272425|NCT00063258|B1|Baseline|Chemotherapy + Tarceva|
272426|NCT00063258|P2|Participant Flow|Chemotherapy Alone|
272427|NCT00063258|P1|Participant Flow|Chemotherapy + Tarceva|
272428|NCT00063258|O2|Outcome|Chemotherapy Alone|
272429|NCT00063258|O1|Outcome|Chemotherapy + Tarceva|
272430|NCT00063258|E2|Reported Event|Chemotherapy Alone|
272431|NCT00063258|E1|Reported Event|Chemotherapy + Tarceva|
272432|NCT00063934|B1|Baseline|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
272433|NCT00063934|P1|Participant Flow|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
272434|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
272435|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
272436|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
272437|NCT00063934|E1|Reported Event|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
272438|NCT00063986|B1|Baseline|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272439|NCT00063986|P1|Participant Flow|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272440|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272441|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272634|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
272442|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272443|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272444|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272445|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272446|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272447|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272448|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272449|NCT00063986|E1|Reported Event|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Only eligible and treated patients are included in the primary analysis."
272450|NCT00064025|B1|Baseline|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
272451|NCT00064025|P1|Participant Flow|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
272452|NCT00064025|O1|Outcome|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
272453|NCT00064025|O1|Outcome|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
272454|NCT00064025|O2|Outcome|PR Positive (>0.2)|
272455|NCT00064025|O1|Outcome|PR Negative (<=0.2)|
272456|NCT00064025|E1|Reported Event|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
272457|NCT00064038|B3|Baseline|Total|Total of all reporting groups
272458|NCT00064038|B2|Baseline|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
272459|NCT00064038|B1|Baseline|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
272460|NCT00064038|P3|Participant Flow|Crossover to Lenalidomide+Dexamethasone|"Patients who have progressive or relapsed disease or who experience unacceptable toxicity attributable to dexamethasone dosing level -2 while on blinded treatment, will be unblinded. Patients shown to have been randomized to DEX + Placebo will proceed with crossover registration and Open-Label Induction with DEX + CC-5013or with open-label CC-5013 alone if they are unblinded due to dexamethasone toxicity.
Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
272461|NCT00064038|P2|Participant Flow|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
272462|NCT00064038|P1|Participant Flow|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
272463|NCT00064038|O2|Outcome|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
272582|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272464|NCT00064038|O1|Outcome|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
272465|NCT00064038|O3|Outcome|Crossover to Rev+Dex|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
272466|NCT00064038|O2|Outcome|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
272467|NCT00064038|O1|Outcome|Lenalidomide and Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
272468|NCT00064038|E3|Reported Event|Crossover to Rev+Dex|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
272469|NCT00064038|E2|Reported Event|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
272470|NCT00064038|E1|Reported Event|Lenalidomide and Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
272471|NCT00064259|B1|Baseline|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
272472|NCT00064259|P4|Participant Flow|Oblimersen 7 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 7 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
272473|NCT00064259|P3|Participant Flow|Oblimersen 5 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 5 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
272474|NCT00064259|P2|Participant Flow|Oblimersen 3 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
272475|NCT00064259|P1|Participant Flow|Oblimersen 3 mg/kg/d +Cisplatin 100 mg/m2 +5-FU 1000 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 1000 mg/m2/d on days 4 to 7 and cisplatin 100 mg/m2 on day 4.
272476|NCT00064259|O1|Outcome|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
272477|NCT00064259|E1|Reported Event|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
272478|NCT00064298|B3|Baseline|Total|Total of all reporting groups
272479|NCT00064298|B2|Baseline|Arm II - Control|"Patients receive oral placebo twice daily.
placebo: Given orally"
272480|NCT00064298|B1|Baseline|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally"
272481|NCT00064298|P2|Participant Flow|Arm II - Control|"Patients receive oral placebo twice daily.
placebo: Given orally"
272482|NCT00064298|P1|Participant Flow|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally"
272483|NCT00064298|O2|Outcome|Arm II - Control|"Patients receive oral placebo twice daily.
placebo: Given orally"
272484|NCT00064298|O1|Outcome|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally"
272485|NCT00064298|O2|Outcome|Arm II - Control|"Patients receive oral placebo twice daily.
placebo: Given orally"
272486|NCT00064298|O1|Outcome|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally"
272487|NCT00064298|E2|Reported Event|Arm II - Control|"Patients receive oral placebo twice daily.
placebo: Given orally"
272488|NCT00064298|E1|Reported Event|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally"
272489|NCT00064350|B4|Baseline|Total|Total of all reporting groups
272505|NCT00064350|E4|Reported Event|Randomization (Step 2): Mixed|"After induction treatment, patients with stable disease were randomized to receive either sorafenib or placebo. Due to drug dispensing error, 10 patients from the sorafenib arm and 2 patients from the placebo arm (12 pts in total) received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities."
272790|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272490|NCT00064350|B3|Baseline|Induction, Not Randomized|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity.
Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.
Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm.
To show baseline characteristics for eligible and treated patients in both the randomization phase (the most important part of this study) and the induction phase, this group contains the following patients:
eligible and treated patients who were not randomized (n=194)
randomized patients who were not eligible or did not start treatment in the randomization phase (n=24)
There were 218 patients in this group so the total number of patients is 299 and the entire cohort represents all eligible and treated patients in the induction phase."
272491|NCT00064350|B2|Baseline|Induction Then Placebo Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.
Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm."
272492|NCT00064350|B1|Baseline|Induction Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization.
Randomization: Patients with stable disease after the induction treatment were randomized to receive either sorafenib or placebo. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.
In the study design, only patients on the placebo arm with progressive disease may cross over to receive sorafenib. Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them."
272493|NCT00064350|P3|Participant Flow|Induction, Not Randomized|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity.
Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.
Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients in this group did not enter Step 2 (randomization part) after the induction phase."
272494|NCT00064350|P2|Participant Flow|Induction Then Placebo Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.
Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm."
272495|NCT00064350|P1|Participant Flow|Induction Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization.
Randomization: Patients with stable disease after the induction treatment were randomized to receive either sorafenib or placebo. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.
In the study design, only patients on the placebo arm with progressive disease may cross over to receive sorafenib. Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them."
272496|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
272497|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
272498|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
272499|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
272500|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
272501|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
272502|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
272503|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
272504|NCT00064350|E5|Reported Event|Crossover: Sorafenib|Patients on the placebo arm who develop progressive disease may cross over to receive sorafenib, and 27 patients from the placebo arm received sorafenib in Step 3 (crossover). Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them. In total, 37 patients registered to step 3 (crossover). Of these, 35 patients received treatment and were included in the toxicity analysis for the crossover (step 3) part.
272581|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272506|NCT00064350|E3|Reported Event|Randomization (Step 2): Placebo|"After induction treatment, 46 patients were randomized to the placebo arm. Among these, 40 received treatment. However, due to drug dispensing error, 2 of them received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities. As a result, 38 treated patients were included in the randomization (step 2): placebo group."
272507|NCT00064350|E2|Reported Event|Randomization (Step 2): Sorafenib|"After induction treatment, 59 patients were randomized to the sorafenib arm. Among these, 55 received treatment. However, due to drug dispensing error, 10 of them received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities. As a result, 45 treated patients were included in the randomization (step 2): sorafenib group."
272508|NCT00064350|E1|Reported Event|Induction: Sorafenib|All patients who received induction treatment (333 patients), regardless of eligibility status, were included in the toxicity analysis.
272509|NCT00064662|B3|Baseline|Total|Total of all reporting groups
272510|NCT00064662|B2|Baseline|Sling|Pubovaginal sling, using autologous rectus fascia
272511|NCT00064662|B1|Baseline|Burch|The Burch colposuspension
272512|NCT00064662|P2|Participant Flow|Sling|Pubovaginal sling, using autologous rectus fascia
272513|NCT00064662|P1|Participant Flow|Burch|The Burch colposuspension
272514|NCT00064662|O2|Outcome|Sling|Pubovaginal sling, using autologous rectus fascia
272515|NCT00064662|O1|Outcome|Burch|The Burch colposuspension
272516|NCT00064662|O2|Outcome|Sling|Pubovaginal sling, using autologous rectus fascia
272517|NCT00064662|O1|Outcome|Burch|The Burch colposuspension
272518|NCT00064662|E2|Reported Event|Sling|Pubovaginal sling, using autologous rectus fascia
272519|NCT00064662|E1|Reported Event|Burch|The Burch colposuspension
272520|NCT00064701|B4|Baseline|Total|Total of all reporting groups
272521|NCT00064701|B3|Baseline|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272522|NCT00064701|B2|Baseline|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272523|NCT00064701|B1|Baseline|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272524|NCT00064701|P3|Participant Flow|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272525|NCT00064701|P2|Participant Flow|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272526|NCT00064701|P1|Participant Flow|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272527|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272528|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272529|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272530|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272531|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272532|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272533|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272534|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272535|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272536|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272537|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272538|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272539|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272540|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272541|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272542|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272543|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272544|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272545|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272546|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272547|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272548|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272549|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272550|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272551|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272552|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272553|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272554|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272555|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272556|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272557|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272558|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272559|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272560|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272561|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272562|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272563|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272564|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272565|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272566|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272567|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272568|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272569|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272570|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272571|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272572|NCT00064701|E3|Reported Event|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272573|NCT00064701|E2|Reported Event|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272574|NCT00064701|E1|Reported Event|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
272575|NCT00064753|B3|Baseline|Total|Total of all reporting groups
272576|NCT00064753|B2|Baseline|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272577|NCT00064753|B1|Baseline|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272578|NCT00064753|P2|Participant Flow|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272579|NCT00064753|P1|Participant Flow|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272580|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272791|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272583|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272584|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272585|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272586|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272587|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272588|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272589|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272590|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272591|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272592|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272593|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272594|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272595|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272596|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272597|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272598|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272599|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272600|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272792|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272601|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272602|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272603|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272604|NCT00064753|E2|Reported Event|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272605|NCT00064753|E1|Reported Event|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12
High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
272606|NCT00064792|B3|Baseline|Total|Total of all reporting groups
272607|NCT00064792|B2|Baseline|Simvastatin Followed by Placebo|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
272608|NCT00064792|B1|Baseline|Placebo Followed by Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
272609|NCT00064792|P2|Participant Flow|Simvastatin Followed by Placebo|Subjects first received Simvastatin (1mg/kg/day after starting at 0.5mg/kg/day for 6 weeks) in addition to cholesterol 150mg/kg/day for 12 months. After a 2 month wash out period, they then continued with cholesterol supplementation only.
272610|NCT00064792|P1|Participant Flow|Placebo Followed by Simvastatin|Subjects maintained cholesterol intake of 150mg/kg/day for 12 months. After a 2 month wash out period, they then received Simvastatin 1mg/kg/day (after starting at 0.5mg/kg/day for 6 weeks) in addition to cholesterol.
272611|NCT00064792|O2|Outcome|Simvastatin|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
272612|NCT00064792|O1|Outcome|Not Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension (OraPlus) not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
272613|NCT00064792|O2|Outcome|Simvastatin|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
272614|NCT00064792|O1|Outcome|Not Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension (OraPlus) not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
272615|NCT00064792|E2|Reported Event|Simvastatin Susp|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
272616|NCT00064792|E1|Reported Event|OraPlus|During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
272617|NCT00064844|B3|Baseline|Total|Total of all reporting groups
272618|NCT00064844|B2|Baseline|Nicotine Patch Plus Placebo Gum|
272619|NCT00064844|B1|Baseline|Nicotine Patch Plus Active Gum|
272620|NCT00064844|P2|Participant Flow|Nicotine Patch Plus Placebo Gum|
272621|NCT00064844|P1|Participant Flow|Nicotine Patch Plus Active Gum|
272622|NCT00064844|O2|Outcome|Nicotine Patch Plus Placebo Gum|
272623|NCT00064844|O1|Outcome|Nicotine Patch Plus Active Gum|
272624|NCT00064844|O2|Outcome|Nicotine Patch Plus Placebo Gum|
272625|NCT00064844|O1|Outcome|Nicotine Patch Plus Active Gum|
272626|NCT00064844|E2|Reported Event|Nicotine Patch Plus Placebo Gum|
272627|NCT00064844|E1|Reported Event|Nicotine Patch Plus Active Gum|
272628|NCT00064987|B3|Baseline|Total|Total of all reporting groups
272629|NCT00064987|B2|Baseline|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
272630|NCT00064987|B1|Baseline|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
272631|NCT00064987|P2|Participant Flow|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
272632|NCT00064987|P1|Participant Flow|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
272633|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
315938|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
272635|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
272636|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
272637|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
272638|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
272639|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
272640|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
272641|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
272642|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
272643|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
272644|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
272645|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
272646|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
272647|NCT00064987|E2|Reported Event|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
272648|NCT00064987|E1|Reported Event|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
272649|NCT00065065|B3|Baseline|Total|Total of all reporting groups
272650|NCT00065065|B2|Baseline|Placebo|Identical in appearance to study drug taken twice a day
272651|NCT00065065|B1|Baseline|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
272652|NCT00065065|P2|Participant Flow|Placebo|Placebo identical to study drug twice daily for 12 weeks
272653|NCT00065065|P1|Participant Flow|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily for 12 weeks
272654|NCT00065065|O2|Outcome|Placebo|Identical in appearance to study drug taken twice a day
272655|NCT00065065|O1|Outcome|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
272656|NCT00065065|O2|Outcome|Placebo|Identical in appearance to study drug taken twice a day
272657|NCT00065065|O1|Outcome|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
272658|NCT00065065|E2|Reported Event|Placebo|Identical in appearance to study drug taken twice a day
272659|NCT00065065|E1|Reported Event|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
272660|NCT00065156|B1|Baseline|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272661|NCT00065156|P1|Participant Flow|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272662|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272793|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272794|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272663|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272664|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272665|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272666|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272667|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272668|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272669|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272670|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272671|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272672|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272673|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272674|NCT00065156|E1|Reported Event|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
272675|NCT00065260|B3|Baseline|Total|Total of all reporting groups
272676|NCT00065260|B2|Baseline|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).
Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
272677|NCT00065260|B1|Baseline|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).
r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days
CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
272678|NCT00065260|P2|Participant Flow|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).
Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
272679|NCT00065260|P1|Participant Flow|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).
r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days
CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
272680|NCT00065260|O2|Outcome|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).
Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
272681|NCT00065260|O1|Outcome|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).
r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days
CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
272682|NCT00065260|E2|Reported Event|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).
Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
272683|NCT00065260|E1|Reported Event|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).
r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days
CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
272684|NCT00065429|B8|Baseline|Total|Total of all reporting groups
272685|NCT00065429|B7|Baseline|IMGN 75 mg/m2|Arm 7, Phase 1
272686|NCT00065429|B6|Baseline|IMGN 67.5 mg/m2|Arm 6, Phase 1
272687|NCT00065429|B5|Baseline|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
272688|NCT00065429|B4|Baseline|IMGN 40 mg/m2|Arm 4, Phase 1
272689|NCT00065429|B3|Baseline|IMGN 20 mg/m2|Arm 3, Phase 1
272690|NCT00065429|B2|Baseline|IMGN 10 mg/m2|Arm 2, Phase 1
272691|NCT00065429|B1|Baseline|IMGN 5 mg/m2|Arm 1, Phase 1
272692|NCT00065429|P7|Participant Flow|IMGN 75 mg/m2|Arm 7, Phase 1
272693|NCT00065429|P6|Participant Flow|IMGN 67.5 mg/m2|Arm 6, Phase 1
272694|NCT00065429|P5|Participant Flow|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
272695|NCT00065429|P4|Participant Flow|IMGN 40 mg/m2|Arm 4, Phase 1
272696|NCT00065429|P3|Participant Flow|IMGN 20 mg/m2|Arm 3, Phase 1
272697|NCT00065429|P2|Participant Flow|IMGN 10 mg/m2|Arm 2, Phase 1
272698|NCT00065429|P1|Participant Flow|IMGN 5 mg/m2|Arm 1, Phase 1
272699|NCT00065429|O2|Outcome|Phase II|For Phase II, the planned design was to use a Gehan's two-stage design [4], with a total of 14 patients assigned to each of 2 dose levels. The dose levels to be tested were to be selected after review of the Phase I data and, assuming evidence of efficacy was seen in that phase, were likely to be the MTD and MTD-1.
272700|NCT00065429|O1|Outcome|Phase I|The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.
272732|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
272733|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
272734|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
272701|NCT00065429|O1|Outcome|Phase I|The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.
272702|NCT00065429|E7|Reported Event|IMGN 75 mg/m2|Arm 7, Phase 1
272703|NCT00065429|E6|Reported Event|IMGN 67.5 mg/m2|Arm 6, Phase 1
272704|NCT00065429|E5|Reported Event|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
272705|NCT00065429|E4|Reported Event|IMGN 40 mg/m2|Arm 4, Phase 1
272706|NCT00065429|E3|Reported Event|IMGN 20 mg/m2|Arm 3, Phase 1
272707|NCT00065429|E2|Reported Event|IMGN 10 mg/m2|Arm 2, Phase 1
272708|NCT00065429|E1|Reported Event|IMGN 5 mg/m2|Arm 1, Phase 1
272709|NCT00065442|B3|Baseline|Total|Total of all reporting groups
272710|NCT00065442|B2|Baseline|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
272711|NCT00065442|B1|Baseline|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
272712|NCT00065442|P2|Participant Flow|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
272713|NCT00065442|P1|Participant Flow|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
272714|NCT00065442|O2|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
272715|NCT00065442|O1|Outcome|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
272716|NCT00065442|O2|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
272717|NCT00065442|O1|Outcome|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
272718|NCT00065442|E2|Reported Event|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
272719|NCT00065442|E1|Reported Event|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
272720|NCT00065468|B4|Baseline|Total|Total of all reporting groups
272721|NCT00065468|B3|Baseline|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
272722|NCT00065468|B2|Baseline|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
272723|NCT00065468|B1|Baseline|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
272724|NCT00065468|P3|Participant Flow|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
272725|NCT00065468|P2|Participant Flow|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
272726|NCT00065468|P1|Participant Flow|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
272727|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
272728|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
272729|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
272730|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
272731|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
272783|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272784|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272735|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
272736|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
272737|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
272738|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
272739|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
272740|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
272741|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
272742|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
272743|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
272744|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
272745|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
272746|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
272747|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
272748|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
272749|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
272750|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
272751|NCT00065468|E3|Reported Event|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
272752|NCT00065468|E2|Reported Event|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
272753|NCT00065468|E1|Reported Event|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
272754|NCT00065507|B3|Baseline|Total|Total of all reporting groups
272755|NCT00065507|B2|Baseline|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272756|NCT00065507|B1|Baseline|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272757|NCT00065507|P2|Participant Flow|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272758|NCT00065507|P1|Participant Flow|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272759|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272760|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272761|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272762|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272763|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272764|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272765|NCT00065507|O4|Outcome|Cumulative - Adefovir (ADV) 10 mg|
272766|NCT00065507|O3|Outcome|Cumulative - Entecavir (ETV) 1.0 mg|
272767|NCT00065507|O2|Outcome|Week 48 - Adefovir (ADV) 10 mg|
272768|NCT00065507|O1|Outcome|Week 48 - Entecavir (ETV) 1.0 mg|
272769|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272770|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272771|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272772|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272773|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272774|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272775|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272776|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272777|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272778|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272779|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272780|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272781|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272782|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272795|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272796|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272797|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272798|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272799|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272800|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272801|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272802|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272803|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272804|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272805|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272806|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272807|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272808|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272809|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272810|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272811|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272812|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272813|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272814|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272815|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
272816|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
272817|NCT00065507|E2|Reported Event|ENTECAVIR|
272818|NCT00065507|E1|Reported Event|ADEFOVIR|
272819|NCT00065611|B3|Baseline|Total|Total of all reporting groups
272820|NCT00065611|B2|Baseline|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
272821|NCT00065611|B1|Baseline|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
272822|NCT00065611|P2|Participant Flow|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
272823|NCT00065611|P1|Participant Flow|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
272824|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
272825|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
272826|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
272827|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
272828|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
272829|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
272830|NCT00065611|E2|Reported Event|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
272831|NCT00065611|E1|Reported Event|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
272832|NCT00065806|B3|Baseline|Total|Total of all reporting groups
272833|NCT00065806|B2|Baseline|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272834|NCT00065806|B1|Baseline|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272835|NCT00065806|P2|Participant Flow|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272893|NCT00066066|E6|Reported Event|SRP and Amoxicillin, MET, Local Tetracycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
315939|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
272836|NCT00065806|P1|Participant Flow|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272837|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272838|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272839|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272840|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272841|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272842|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272843|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272968|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
315940|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
272844|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272845|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272846|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272847|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272848|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272849|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272850|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272851|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272969|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
315941|NCT00250679|E3|Reported Event|Arformoterol 25 Mcg 2x/Day|
272852|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272853|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272854|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272855|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272856|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272857|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272858|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272859|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272970|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
272971|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
272860|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272861|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272862|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272863|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272864|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272865|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272866|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272867|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272972|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
315942|NCT00250679|E2|Reported Event|Arformoterol 15 Mcg 2x/Day|
272868|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272869|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272870|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272871|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272872|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272873|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272874|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272875|NCT00065806|E2|Reported Event|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272973|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
315943|NCT00250679|E1|Reported Event|Formoterol 12 Mcg 2x/Day|
272876|NCT00065806|E1|Reported Event|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.
Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
272877|NCT00066066|B4|Baseline|Total|Total of all reporting groups
272878|NCT00066066|B3|Baseline|SRP and Amoxicillin, MET and Locally Delivered Tetracycline|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
272879|NCT00066066|B2|Baseline|SRP and Metronidazole (MET)|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
272880|NCT00066066|B1|Baseline|Scaling and Root Planing (SRP) Only|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
272881|NCT00066066|P6|Participant Flow|SRP and Amoxicillin, MET, Local Tetracycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
272882|NCT00066066|P5|Participant Flow|SRP and Amoxicillin, MET, Local Tetracycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
272883|NCT00066066|P4|Participant Flow|SRP and Metronidazole (MET) Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
272884|NCT00066066|P3|Participant Flow|SRP and Metronidazole (MET) NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
272885|NCT00066066|P2|Participant Flow|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
272886|NCT00066066|P1|Participant Flow|Scaling and Root Planing (SRP) Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
272887|NCT00066066|O6|Outcome|SRP + MET + Amoxicillin + Doxycycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
272888|NCT00066066|O5|Outcome|SRP + MET + Amoxicillin + Doxycycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
272889|NCT00066066|O4|Outcome|SRP + Metronidazole Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
272890|NCT00066066|O3|Outcome|SRP + Metronidazole NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
272891|NCT00066066|O2|Outcome|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
272892|NCT00066066|O1|Outcome|Scaling and Root Planing Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
273458|NCT00069641|P3|Participant Flow|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
272894|NCT00066066|E5|Reported Event|SRP and Amoxicillin, MET, Local Tetracycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
272895|NCT00066066|E4|Reported Event|SRP and Metronidazole (MET) Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
272896|NCT00066066|E3|Reported Event|SRP and Metronidazole (MET) NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
272897|NCT00066066|E2|Reported Event|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
272898|NCT00066066|E1|Reported Event|Scaling and Root Planing (SRP) Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
272899|NCT00066170|B5|Baseline|Total|Total of all reporting groups
272900|NCT00066170|B4|Baseline|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
272901|NCT00066170|B3|Baseline|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
272902|NCT00066170|B2|Baseline|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
272903|NCT00066170|B1|Baseline|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
272904|NCT00066170|P4|Participant Flow|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
272905|NCT00066170|P3|Participant Flow|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
272906|NCT00066170|P2|Participant Flow|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
272907|NCT00066170|P1|Participant Flow|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
272908|NCT00066170|O4|Outcome|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
272909|NCT00066170|O3|Outcome|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
272910|NCT00066170|O2|Outcome|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
272911|NCT00066170|O1|Outcome|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
272912|NCT00066170|E4|Reported Event|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
272913|NCT00066170|E3|Reported Event|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
272914|NCT00066170|E2|Reported Event|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
272915|NCT00066170|E1|Reported Event|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
272916|NCT00066222|B1|Baseline|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
272917|NCT00066222|P1|Participant Flow|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
272918|NCT00066222|O1|Outcome|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
272919|NCT00066222|E1|Reported Event|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
272920|NCT00066365|B3|Baseline|Total|Total of all reporting groups
272974|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
272975|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
272976|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
273499|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
272921|NCT00066365|B2|Baseline|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272922|NCT00066365|B1|Baseline|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272923|NCT00066365|P2|Participant Flow|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272924|NCT00066365|P1|Participant Flow|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272925|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272926|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272927|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272928|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
273500|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
272929|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272930|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272931|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272932|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272933|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272934|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272935|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272936|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
273041|NCT00059475|O1|Outcome|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
272937|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272938|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272939|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272940|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272941|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272942|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272943|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms
conventional surgery: thoracotomy"
272944|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
273501|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
272945|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272946|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272947|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272948|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy"
272949|NCT00066365|E2|Reported Event|Group 2 (Bilateral Recurrence)|"(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)
sargramostim: given by inhalation
conventional surgery: thoracotomy"
272950|NCT00066365|E1|Reported Event|Group 1 (Unilateral Recurrence)|"(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)
sargramostim: given by inhalation
conventional surgery: thoracotomy"
272951|NCT00059215|B5|Baseline|Total|Total of all reporting groups
272952|NCT00059215|B4|Baseline|Clopidogrel|Clopidogrel 300-mg oral LD at time of PCI followed by an oral 75-mg MD; taken once a day
272953|NCT00059215|B3|Baseline|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
272954|NCT00059215|B2|Baseline|Prasugrel (CS-747) 60 mg LD/10 mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
272955|NCT00059215|B1|Baseline|Prasugrel (CS-747) 40 mg LD/7.5 mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
272956|NCT00059215|P4|Participant Flow|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
272957|NCT00059215|P3|Participant Flow|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
272958|NCT00059215|P2|Participant Flow|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
272959|NCT00059215|P1|Participant Flow|Prasugrel (CS-747) 40-mg LD/7.5 mg MD|Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
272960|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
272961|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
272962|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
272963|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
272964|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
272965|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
272966|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
272967|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
316002|NCT00251238|B2|Baseline|Control Group|Receiving matching placebo
272977|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
272978|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
272979|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
272980|NCT00059215|E4|Reported Event|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
272981|NCT00059215|E3|Reported Event|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
272982|NCT00059215|E2|Reported Event|Prasugrel (CS-747) 60-mg LD/10 mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
272983|NCT00059215|E1|Reported Event|Prasugrel (CS-747) 40-mg LD/7.5 mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
272984|NCT00059332|B3|Baseline|Total|Total of all reporting groups
272985|NCT00059332|B2|Baseline|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
272986|NCT00059332|B1|Baseline|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
272987|NCT00059332|P2|Participant Flow|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
272988|NCT00059332|P1|Participant Flow|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
272989|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
272990|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
272991|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
272992|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
272993|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
272994|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
272995|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
272996|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
272997|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
272998|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
272999|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
273000|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
273001|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
273002|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
273003|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
273004|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
273005|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
273006|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
273502|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
273007|NCT00059332|E2|Reported Event|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
273008|NCT00059332|E1|Reported Event|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
273009|NCT00059475|B9|Baseline|Total|Total of all reporting groups
273010|NCT00059475|B8|Baseline|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
273011|NCT00059475|B7|Baseline|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
273012|NCT00059475|B6|Baseline|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
273013|NCT00059475|B5|Baseline|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
273014|NCT00059475|B4|Baseline|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
273015|NCT00059475|B3|Baseline|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
273016|NCT00059475|B2|Baseline|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
273017|NCT00059475|B1|Baseline|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
273018|NCT00059475|P8|Participant Flow|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
273019|NCT00059475|P7|Participant Flow|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
273020|NCT00059475|P6|Participant Flow|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
273021|NCT00059475|P5|Participant Flow|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
273022|NCT00059475|P4|Participant Flow|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
273023|NCT00059475|P3|Participant Flow|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
273024|NCT00059475|P2|Participant Flow|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
273025|NCT00059475|P1|Participant Flow|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
273026|NCT00059475|O4|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
273027|NCT00059475|O3|Outcome|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
273028|NCT00059475|O2|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
273029|NCT00059475|O1|Outcome|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
273030|NCT00059475|O8|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
273031|NCT00059475|O7|Outcome|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
273032|NCT00059475|O6|Outcome|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
273033|NCT00059475|O5|Outcome|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
273034|NCT00059475|O4|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
273035|NCT00059475|O3|Outcome|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
273036|NCT00059475|O2|Outcome|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
273037|NCT00059475|O1|Outcome|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
273038|NCT00059475|O4|Outcome|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
273039|NCT00059475|O3|Outcome|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
273040|NCT00059475|O2|Outcome|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
319425|NCT00267202|B3|Baseline|Total|Total of all reporting groups
273042|NCT00059475|E8|Reported Event|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
273043|NCT00059475|E7|Reported Event|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
273044|NCT00059475|E6|Reported Event|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
273045|NCT00059475|E5|Reported Event|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
273046|NCT00059475|E4|Reported Event|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
273047|NCT00059475|E3|Reported Event|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
273048|NCT00059475|E2|Reported Event|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
273049|NCT00059475|E1|Reported Event|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
273050|NCT00059787|B1|Baseline|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies"
273051|NCT00059787|P1|Participant Flow|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies"
273052|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies"
273053|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies"
273054|NCT00059787|O1|Outcome|Paclitaxel, Carboplatin, Erlotinib|"Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib
paclitaxel: Given IV
carboplatin: Given IV
erlotinib: Given PO"
273055|NCT00059787|O1|Outcome|Paclitaxel, Carboplatin, Erlotinib|"Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib
paclitaxel: Given IV
carboplatin: Given IV
erlotinib: Given PO"
273056|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies"
273057|NCT00059787|E1|Reported Event|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies"
273058|NCT00059839|B3|Baseline|Total|Total of all reporting groups
273059|NCT00059839|B2|Baseline|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
319533|NCT00267774|B1|Baseline|FFR Guided PCI|Fractional flow reserve
273060|NCT00059839|B1|Baseline|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
273061|NCT00059839|P2|Participant Flow|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
273062|NCT00059839|P1|Participant Flow|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
273063|NCT00059839|O2|Outcome|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
273064|NCT00059839|O1|Outcome|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
273065|NCT00059839|E2|Reported Event|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
273066|NCT00059839|E1|Reported Event|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
273067|NCT00060008|B1|Baseline|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.
fludeoxyglucose F 18
gadopentetate dimeglumine"
273068|NCT00060008|P1|Participant Flow|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.
fludeoxyglucose F 18
gadopentetate dimeglumine"
273069|NCT00060008|O2|Outcome|SUVmax >2|Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
273070|NCT00060008|O1|Outcome|SUVmax < 2|Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
273129|NCT00066781|O2|Outcome|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
319534|NCT00267774|P2|Participant Flow|Angio-guided PCI|Angio-guided PCI
273071|NCT00060008|E1|Reported Event|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.
fludeoxyglucose F 18
gadopentetate dimeglumine"
273072|NCT00066469|B1|Baseline|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
273073|NCT00066469|P1|Participant Flow|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
273074|NCT00066469|O1|Outcome|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
273075|NCT00066469|E1|Reported Event|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
273076|NCT00066573|B3|Baseline|Total|Total of all reporting groups
273077|NCT00066573|B2|Baseline|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.
anastrozole: Given orally"
273078|NCT00066573|B1|Baseline|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.
exemestane: Given orally"
273079|NCT00066573|P2|Participant Flow|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.
anastrozole: Given orally"
273080|NCT00066573|P1|Participant Flow|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.
exemestane: Given orally"
273081|NCT00066573|O2|Outcome|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.
anastrozole: Given orally"
273082|NCT00066573|O1|Outcome|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.
exemestane: Given orally"
273083|NCT00066573|E2|Reported Event|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.
anastrozole: Given orally"
273084|NCT00066573|E1|Reported Event|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.
exemestane: Given orally"
273085|NCT00066690|B4|Baseline|Total|Total of all reporting groups
273086|NCT00066690|B3|Baseline|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273087|NCT00066690|B2|Baseline|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273088|NCT00066690|B1|Baseline|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
273089|NCT00066690|P3|Participant Flow|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273090|NCT00066690|P2|Participant Flow|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273091|NCT00066690|P1|Participant Flow|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
273092|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273093|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273094|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
273095|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273096|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273097|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
273098|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273099|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273100|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
273101|NCT00066690|E3|Reported Event|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273102|NCT00066690|E2|Reported Event|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
273103|NCT00066690|E1|Reported Event|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
273104|NCT00066703|B3|Baseline|Total|Total of all reporting groups
273508|NCT00069823|P2|Participant Flow|Esomeprazole|40 mg of esomeprazole twice daily
273105|NCT00066703|B2|Baseline|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273106|NCT00066703|B1|Baseline|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273107|NCT00066703|P2|Participant Flow|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273108|NCT00066703|P1|Participant Flow|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273109|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273110|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273111|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273112|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273113|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273114|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273115|NCT00066703|E2|Reported Event|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273116|NCT00066703|E1|Reported Event|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
273117|NCT00066742|B1|Baseline|Evaluable Patients|Only eligible patients who received the study intervention were included in the analysis.
273118|NCT00066742|P1|Participant Flow|Evaluable Patients|Only eligible patients who received the study intervention were included in the analysis.
273119|NCT00066742|O1|Outcome|Evaluable Patients|
273120|NCT00066742|O1|Outcome|Evaluable Patients With Measurable Disease|Only eligible patients who received protocol treatment and who had measurable lesions (per RECIST) at baseline were included in this analysis.
273121|NCT00066742|O1|Outcome|Evaluable Patients|
273122|NCT00066742|E2|Reported Event|Consolidation Cisplatin + Etoposide|
273123|NCT00066742|E1|Reported Event|Tirapazamine + Cisplatin + Etoposide + Concurrent Radiotherapy|
273124|NCT00066781|B3|Baseline|Total|Total of all reporting groups
273125|NCT00066781|B2|Baseline|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
273126|NCT00066781|B1|Baseline|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
273127|NCT00066781|P2|Participant Flow|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
273128|NCT00066781|P1|Participant Flow|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
273503|NCT00069784|E2|Reported Event|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
273130|NCT00066781|O1|Outcome|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
273131|NCT00066781|O2|Outcome|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
273132|NCT00066781|O1|Outcome|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
273133|NCT00066781|O2|Outcome|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
273134|NCT00066781|O1|Outcome|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
273135|NCT00066781|E2|Reported Event|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
273136|NCT00066781|E1|Reported Event|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
273137|NCT00067470|B3|Baseline|Total|Total of all reporting groups
273138|NCT00067470|B2|Baseline|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
273139|NCT00067470|B1|Baseline|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
273140|NCT00067470|P2|Participant Flow|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
273141|NCT00067470|P1|Participant Flow|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
273142|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
273143|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
273144|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
273145|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
273146|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
273147|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
273148|NCT00067470|E2|Reported Event|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
273149|NCT00067470|E1|Reported Event|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
273150|NCT00067808|B4|Baseline|Total|Total of all reporting groups
273151|NCT00067808|B3|Baseline|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
273152|NCT00067808|B2|Baseline|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
273153|NCT00067808|B1|Baseline|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
273154|NCT00067808|P3|Participant Flow|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
273155|NCT00067808|P2|Participant Flow|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
273156|NCT00067808|P1|Participant Flow|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
273157|NCT00067808|O3|Outcome|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
273158|NCT00067808|O2|Outcome|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
273159|NCT00067808|O1|Outcome|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
273160|NCT00067808|E3|Reported Event|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
273161|NCT00067808|E2|Reported Event|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
273162|NCT00067808|E1|Reported Event|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
273163|NCT00068107|B1|Baseline|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
273164|NCT00068107|P1|Participant Flow|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month. Patients will receive a dose of 0.2 mg/kg of body weight every week.
273165|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
273166|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month. Patients will receive a dose of 0.2 mg/kg of body weight every week.
273167|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
273168|NCT00068107|O2|Outcome|All Participants at Last Observation|
273169|NCT00068107|O1|Outcome|All Participants at Baseline|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
273170|NCT00068107|O2|Outcome|All Participants at Last Observation|
273171|NCT00068107|O1|Outcome|All Participants at Baseline|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
273172|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
273173|NCT00068107|E1|Reported Event|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
273174|NCT00068237|B1|Baseline|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
273175|NCT00068237|P1|Participant Flow|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
273176|NCT00068237|O1|Outcome|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
273177|NCT00068237|E1|Reported Event|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
273178|NCT00068341|B4|Baseline|Total|Total of all reporting groups
273179|NCT00068341|B3|Baseline|HER2/Neu Negative Patients|"please see intervention description
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
273180|NCT00068341|B2|Baseline|Arm II (Neoadjuvant Therapy)|"please see intervention description
trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
273181|NCT00068341|B1|Baseline|Arm I (Neoadjuvant Therapy)|"see intervention description
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV"
273182|NCT00068341|P3|Participant Flow|HER2/Neu Negative Patients|"please see intervention description
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
273183|NCT00068341|P2|Participant Flow|Arm II (Neoadjuvant Therapy)|"please see intervention description
trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
273184|NCT00068341|P1|Participant Flow|Arm I (Neoadjuvant Therapy)|"see intervention description
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV (AUC = area under the curve, total drug exposure over time)
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV"
273185|NCT00068341|O3|Outcome|Her2- (Pre-op TC)|enrolled subjects
273186|NCT00068341|O2|Outcome|Her2+ (Pre-op TC, Post-op Herceptin)|enrolled subjects
273187|NCT00068341|O1|Outcome|Arm I (Pre-op TCH)|enrolled subjects
273188|NCT00068341|O2|Outcome|Pathologic CR - No|All enrolled subjects
273189|NCT00068341|O1|Outcome|Pathologic CR - Yes|All enrolled subjects
273190|NCT00068341|O3|Outcome|Arm III: Her -|all enrolled subjects
273191|NCT00068341|O2|Outcome|Arm II: Her2 +|all enrolled subjects
273192|NCT00068341|O1|Outcome|Arm I: Her2 +|all enrolled subjects
273193|NCT00068341|O3|Outcome|Arm III: Her2-|all evaluated subjects.
273194|NCT00068341|O2|Outcome|Arm II:Her2+|all evaluated subjects.
273195|NCT00068341|O1|Outcome|Arm I: Her2+|all evaluated subjects.
273196|NCT00068341|O4|Outcome|Total|
273197|NCT00068341|O3|Outcome|HER2-|(Pre-Op TC)
273198|NCT00068341|O2|Outcome|Arm II: HER2+|(Pre-Op TC, Post-Op Herceptin)
273199|NCT00068341|O1|Outcome|Arm I: HER2+|(Pre-Op TCH)
273200|NCT00068341|E4|Reported Event|Total|
273201|NCT00068341|E3|Reported Event|Arm III: HER2- (Pre-Op TC)|HER2/neu negative patients carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
273202|NCT00068341|E2|Reported Event|Arm II: HER2+ (Pre-Op TC, Post-Op Herceptin)|Arm II trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
273203|NCT00068341|E1|Reported Event|Arm I: HER+ (Pre-Op TCH)|Arm I carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
273204|NCT00068380|B1|Baseline|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies"
273205|NCT00068380|P1|Participant Flow|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies"
273206|NCT00068380|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies"
273207|NCT00068380|E1|Reported Event|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies"
273226|NCT00068588|P3|Participant Flow|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273227|NCT00068588|P2|Participant Flow|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273208|NCT00068393|B1|Baseline|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.
Only eligible and treated patients are included in the analysis."
273209|NCT00068393|P1|Participant Flow|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.
Only eligible and treated patients are included in the analysis."
273210|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.
Only eligible and treated patients are included in the analysis."
273211|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.
Only eligible and treated patients are included in the analysis."
273212|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.
Only eligible and treated patients are included in the analysis."
273213|NCT00068393|E1|Reported Event|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.
Only eligible and treated patients are included in the analysis."
273214|NCT00068419|B1|Baseline|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
273215|NCT00068419|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
273216|NCT00068419|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
273217|NCT00068419|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
273218|NCT00068575|B1|Baseline|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
273219|NCT00068575|P1|Participant Flow|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
273220|NCT00068575|O1|Outcome|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
273221|NCT00068575|E1|Reported Event|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
273222|NCT00068588|B4|Baseline|Total|Total of all reporting groups
273223|NCT00068588|B3|Baseline|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273224|NCT00068588|B2|Baseline|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273225|NCT00068588|B1|Baseline|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273284|NCT00069095|B7|Baseline|Total|Total of all reporting groups
273228|NCT00068588|P1|Participant Flow|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273229|NCT00068588|O3|Outcome|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273230|NCT00068588|O2|Outcome|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273231|NCT00068588|O1|Outcome|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273232|NCT00068588|O3|Outcome|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273233|NCT00068588|O2|Outcome|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273234|NCT00068588|O1|Outcome|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273235|NCT00068588|E2|Reported Event|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273236|NCT00068588|E1|Reported Event|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
273237|NCT00068601|B3|Baseline|Total|Total of all reporting groups
273238|NCT00068601|B2|Baseline|Arm 2|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.
cyclophosphamide: Part of planned chemotherapy regimen
goserelin acetate: Given subcutaneously"
273239|NCT00068601|B1|Baseline|Arm 1|"Patients receive cyclophosphamide-containing chemotherapy alone.
cyclophosphamide: Part of planned chemotherapy regimen"
273240|NCT00068601|P2|Participant Flow|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.
cyclophosphamide: Part of planned chemotherapy regimen
goserelin acetate: Given subcutaneously"
273241|NCT00068601|P1|Participant Flow|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.
cyclophosphamide: Part of planned chemotherapy regimen"
273242|NCT00068601|O2|Outcome|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.
cyclophosphamide: Part of planned chemotherapy regimen
goserelin acetate: Given subcutaneously"
273243|NCT00068601|O1|Outcome|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.
cyclophosphamide: Part of planned chemotherapy regimen"
273244|NCT00068601|O2|Outcome|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.
cyclophosphamide: Part of planned chemotherapy regimen
goserelin acetate: Given subcutaneously"
273245|NCT00068601|O1|Outcome|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.
cyclophosphamide: Part of planned chemotherapy regimen"
273246|NCT00068601|O2|Outcome|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.
cyclophosphamide: Part of planned chemotherapy regimen
goserelin acetate: Given subcutaneously"
273247|NCT00068601|O1|Outcome|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.
cyclophosphamide: Part of planned chemotherapy regimen"
273248|NCT00068601|E2|Reported Event|Chemotherapy Plus Goserelin|Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen. goserelin acetate: Given subcutaneously
273249|NCT00068601|E1|Reported Event|Standard Chemotherapy|Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen
273250|NCT00068718|B1|Baseline|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV"
273251|NCT00068718|P1|Participant Flow|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV"
273252|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV"
273253|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV"
273446|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273254|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV"
273255|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV"
273256|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV"
273257|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV"
273258|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV"
273259|NCT00068718|E1|Reported Event|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV"
273260|NCT00068770|B3|Baseline|Total|Total of all reporting groups
273261|NCT00068770|B2|Baseline|nonp450 (-EIASD)|not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate.
273262|NCT00068770|B1|Baseline|p450 ( +EIASD)|on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)
273263|NCT00068770|P2|Participant Flow|p450|"on p450 inhibitor
celecoxib :
radiation therapy :"
273264|NCT00068770|P1|Participant Flow|nonp450|"not on p450 inhibitor
celecoxib :
radiation therapy :"
273265|NCT00068770|O2|Outcome|nonp450 (-EIASD)|"not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate.
latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group"
273266|NCT00068770|O1|Outcome|p450 ( +EIASD)|"on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)
latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group"
273267|NCT00068770|O2|Outcome|p450|"on p450 inhibitor
celecoxib :
radiation therapy :"
273268|NCT00068770|O1|Outcome|nonp450|"not on p450 inhibitor
celecoxib :
radiation therapy :"
273269|NCT00068770|E2|Reported Event|Non P450 ARM|NOT on p450 inhibitor *non P450 ARM (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate, Keppra.
273270|NCT00068770|E1|Reported Event|P450 ARM|on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)
273271|NCT00068822|B3|Baseline|Total|Total of all reporting groups
273272|NCT00068822|B2|Baseline|Control Group|Participants will receive partial vertebroplasty without PMMA
273273|NCT00068822|B1|Baseline|Vertebroplasty|Participants will receive percutaneous vertebroplasty
273274|NCT00068822|P2|Participant Flow|Control, Then Vertebroplasty|Participants randomized to receive Control procedure, Sham Vertebroplasty first (Partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.) At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative percutaneous vertebroplasty (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture).
273275|NCT00068822|P1|Participant Flow|Vertebroplasty, Then Control|Participants randomized to receive percutaneous vertebroplasty first (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture). At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative Control procedure, Sham Vertebroplasty (partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.)
273276|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
273277|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
273278|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
273279|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
273280|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
273281|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
273282|NCT00068822|E2|Reported Event|Control Group|Participants will receive partial vertebroplasty without PMMA
273283|NCT00068822|E1|Reported Event|Vertebroplasty|Participants will receive percutaneous vertebroplasty
273285|NCT00069095|B6|Baseline|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273286|NCT00069095|B5|Baseline|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273287|NCT00069095|B4|Baseline|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273288|NCT00069095|B3|Baseline|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273289|NCT00069095|B2|Baseline|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273290|NCT00069095|B1|Baseline|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273291|NCT00069095|P6|Participant Flow|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273317|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273504|NCT00069784|E1|Reported Event|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
273292|NCT00069095|P5|Participant Flow|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273293|NCT00069095|P4|Participant Flow|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273294|NCT00069095|P3|Participant Flow|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273295|NCT00069095|P2|Participant Flow|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273296|NCT00069095|P1|Participant Flow|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273297|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273298|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
273299|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273447|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273448|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273300|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).
Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
273301|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273302|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
273303|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273304|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).
Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
273305|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273306|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
273307|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273318|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
273505|NCT00069823|B3|Baseline|Total|Total of all reporting groups
273641|NCT00063635|O3|Outcome|Placebo|Matching placebo
273308|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).
Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
273309|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273310|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
273311|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273312|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).
Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
273313|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273314|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
273315|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273316|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).
Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
273449|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273319|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273320|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).
Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
273321|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273322|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
273323|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273324|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
273325|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273326|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).
Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
273327|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273450|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273451|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273328|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
273329|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273330|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).
Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
273331|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273332|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
273333|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273334|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).
Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
273335|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273336|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -
Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
273452|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273453|NCT00069329|E1|Reported Event|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273337|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273338|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).
Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
273339|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).
Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
273340|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).
Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).
Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
273341|NCT00069095|E6|Reported Event|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273342|NCT00069095|E5|Reported Event|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273343|NCT00069095|E4|Reported Event|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273355|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273454|NCT00069641|B4|Baseline|Total|Total of all reporting groups
273455|NCT00069641|B3|Baseline|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
273344|NCT00069095|E3|Reported Event|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273345|NCT00069095|E2|Reported Event|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273346|NCT00069095|E1|Reported Event|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
273347|NCT00069108|B3|Baseline|Total|Total of all reporting groups
273348|NCT00069108|B2|Baseline|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273349|NCT00069108|B1|Baseline|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 IV infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273350|NCT00069108|P2|Participant Flow|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273351|NCT00069108|P1|Participant Flow|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273352|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273353|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273354|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273356|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273357|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273358|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273359|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273360|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273361|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273362|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273363|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273364|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273365|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273366|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273456|NCT00069641|B2|Baseline|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
273367|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273368|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273369|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273370|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273371|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273372|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273373|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273374|NCT00069108|E2|Reported Event|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
273375|NCT00069108|E1|Reported Event|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
273376|NCT00069121|B3|Baseline|Total|Total of all reporting groups
273377|NCT00069121|B2|Baseline|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
273378|NCT00069121|B1|Baseline|5-FU/LV|"Given by one of two regimens.
Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or
Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
273414|NCT00069160|E1|Reported Event|Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
273642|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
273379|NCT00069121|P2|Participant Flow|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
273380|NCT00069121|P1|Participant Flow|5-FU/LV|"Given by one of two regimens.
Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or
Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
273381|NCT00069121|O3|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
273382|NCT00069121|O2|Outcome|5-FU/LV ROSWELL PARK|Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
273383|NCT00069121|O1|Outcome|5-FU/LV MAYO CLINIC|Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks)
273384|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
273385|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.
Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or
Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
273386|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
273387|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.
Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or
Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
273388|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
273389|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.
Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or
Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
273390|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
273391|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.
Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or
Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
273415|NCT00069238|B1|Baseline|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
273457|NCT00069641|B1|Baseline|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
273506|NCT00069823|B2|Baseline|Esomeprazole|40 mg of esomeprazole twice daily
273392|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
273393|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.
Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or
Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
273394|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
273395|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.
Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or
Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
273396|NCT00069121|E3|Reported Event|XELOX|Capecitabine in Combination with Intravenous Oxaliplatin (Q3W)
273397|NCT00069121|E2|Reported Event|5-FU/LV ROSWELL PARK|5-fluorouracil/leucovorin
273398|NCT00069121|E1|Reported Event|5-FU/LV MAYO CLINIC|5-fluorouracil/leucovorin
273399|NCT00069160|B3|Baseline|Total|Total of all reporting groups
273400|NCT00069160|B2|Baseline|Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
273401|NCT00069160|B1|Baseline|Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
273402|NCT00069160|P2|Participant Flow|Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
273403|NCT00069160|P1|Participant Flow|Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
273404|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
273405|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
273406|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
273407|NCT00069160|O2|Outcome|With Tariquidar|40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
273408|NCT00069160|O1|Outcome|Docetaxel Alone|40 mg/m^2 docetaxel over 1 hour on days 1 and 8.
273409|NCT00069160|O2|Outcome|Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
273410|NCT00069160|O1|Outcome|Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
273411|NCT00069160|O2|Outcome|With Tariquidar|40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
273412|NCT00069160|O1|Outcome|Docetaxel Alone|40 mg/m^2 docetaxel over 1 hour on days 1 and 8.
273413|NCT00069160|E2|Reported Event|Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
273445|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273416|NCT00069238|P3|Participant Flow|Alemtuzumab 90 mg|Alemtuzumab (Campath) 90mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
273417|NCT00069238|P2|Participant Flow|Alemtuzumab 60 mg|Alemtuzumab (Campath) 60mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
273418|NCT00069238|P1|Participant Flow|Alemtuzumab 30 mg|Alemtuzumab (Campath) 30mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
273419|NCT00069238|O1|Outcome|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
273420|NCT00069238|O1|Outcome|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
273421|NCT00069238|E1|Reported Event|All Participants|"All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
The adverse events are not reported per dose level because we normally look at all adverse events together irrespective of the dose level."
273422|NCT00069264|B1|Baseline|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
273423|NCT00069264|P1|Participant Flow|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
273424|NCT00069264|O1|Outcome|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
273425|NCT00069264|E1|Reported Event|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
273426|NCT00069277|B1|Baseline|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
273427|NCT00069277|P1|Participant Flow|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
273428|NCT00069277|O1|Outcome|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
273429|NCT00069277|E1|Reported Event|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
273430|NCT00069329|B1|Baseline|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273431|NCT00069329|P1|Participant Flow|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273432|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273433|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273434|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273435|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273436|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273437|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273438|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273439|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273440|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273441|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273442|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273443|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273444|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
273459|NCT00069641|P2|Participant Flow|Idursulfase Every Other Week (EOW) (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
273460|NCT00069641|P1|Participant Flow|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 milligram per kilogram (mg/kg) administered once-weekly by intravenous infusion for one year (52 infusions).
273461|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
273462|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
273463|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
273464|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
273465|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
273466|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
273467|NCT00069641|O2|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
273468|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
273469|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
273470|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
273471|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
273472|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
273473|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
273474|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
273475|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
273476|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
273477|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
273478|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
273479|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
273480|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
273481|NCT00069641|E3|Reported Event|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
273482|NCT00069641|E2|Reported Event|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
273483|NCT00069641|E1|Reported Event|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
273484|NCT00069784|B3|Baseline|Total|Total of all reporting groups
273485|NCT00069784|B2|Baseline|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
273486|NCT00069784|B1|Baseline|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
273487|NCT00069784|P2|Participant Flow|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
273488|NCT00069784|P1|Participant Flow|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
273489|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
273490|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
273491|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
273492|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
273493|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
273494|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
273495|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
273496|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
273497|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
273498|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
273509|NCT00069823|P1|Participant Flow|Placebo|40 mg of placebo twice daily
273510|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273511|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273512|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273513|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273514|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273515|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273516|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273517|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273518|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273519|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273520|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273521|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273522|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273523|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273524|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273525|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273526|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273527|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273528|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273529|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273530|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273531|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273532|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273533|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273534|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273535|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273536|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273537|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273538|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273539|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273540|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273541|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273542|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273543|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273544|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
273545|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
273546|NCT00069823|E2|Reported Event|Esomeprazole|40 mg of esomeprazole twice daily
273547|NCT00069823|E1|Reported Event|Placebo|40 mg of placebo twice daily
273548|NCT00069953|B1|Baseline|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
273549|NCT00069953|P1|Participant Flow|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
273550|NCT00069953|O1|Outcome|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
273551|NCT00069953|E1|Reported Event|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
273552|NCT00070018|B1|Baseline|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
273553|NCT00070018|P1|Participant Flow|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
273554|NCT00070018|O1|Outcome|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
273555|NCT00070018|E1|Reported Event|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
273556|NCT00063362|B3|Baseline|Total|Total of all reporting groups
273557|NCT00063362|B2|Baseline|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.
Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
273558|NCT00063362|B1|Baseline|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.
Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.
dose of 200 mg per day.
Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
273559|NCT00063362|P2|Participant Flow|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.
Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
273560|NCT00063362|P1|Participant Flow|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.
Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.
dose of 200 mg per day.
Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 milliequivalent/L (mEq/L)."
273561|NCT00063362|O2|Outcome|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.
Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
273562|NCT00063362|O1|Outcome|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.
Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.
dose of 200 mg per day.
Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
273563|NCT00063362|E2|Reported Event|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.
Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
273564|NCT00063362|E1|Reported Event|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.
Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.
dose of 200 mg per day.
Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
273565|NCT00063570|B3|Baseline|Total|Total of all reporting groups
273566|NCT00063570|B2|Baseline|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
273567|NCT00063570|B1|Baseline|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
273568|NCT00063570|P2|Participant Flow|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
273569|NCT00063570|P1|Participant Flow|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
273570|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
273571|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
273572|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
273573|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
273643|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
273644|NCT00063635|O3|Outcome|Placebo|Matching placebo
273574|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
273575|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
273576|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
273577|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
273578|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
273579|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
273580|NCT00063570|E2|Reported Event|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.
Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
273581|NCT00063570|E1|Reported Event|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.
Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
273582|NCT00063622|B4|Baseline|Total|Total of all reporting groups
273583|NCT00063622|B3|Baseline|Placebo|Placebo Pioglitazone and Placebo Vitamin E
273584|NCT00063622|B2|Baseline|Vitamin E|Vitamin E at a dose of 800 IU daily
273585|NCT00063622|B1|Baseline|Pioglitazone|Pioglitazone at a dose of 30 mg daily
273586|NCT00063622|P3|Participant Flow|Placebo|Placebo Pioglitazone and Placebo Vitamin E
273587|NCT00063622|P2|Participant Flow|Vitamin E|Vitamin E at a dose of 800 IU daily
273588|NCT00063622|P1|Participant Flow|Pioglitazone|Pioglitazone at a dose of 30 mg daily
273589|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
273590|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
273591|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
273592|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
273593|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
273594|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
273595|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
273596|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
273597|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
273598|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
273599|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
273600|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
273601|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
273602|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
273603|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
273604|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
273605|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
273606|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
273607|NCT00063622|E3|Reported Event|Placebo|Placebo Pioglitazone and Placebo Vitamin E
273608|NCT00063622|E2|Reported Event|Vitamin E|Vitamin E at a dose of 800 IU daily
273609|NCT00063622|E1|Reported Event|Pioglitazone|Pioglitazone at a dose of 30 mg daily
273610|NCT00063635|B4|Baseline|Total|Total of all reporting groups
273611|NCT00063635|B3|Baseline|Placebo|Matching placebo
273612|NCT00063635|B2|Baseline|Vitamin E|Vitamin E, 400 IU, twice daily
273613|NCT00063635|B1|Baseline|Metformin|Metformin, 500 mg, twice daily
273614|NCT00063635|P3|Participant Flow|Placebo|Matching placebo
273615|NCT00063635|P2|Participant Flow|Vitamin E|Vitamin E, 400 IU, twice daily
273616|NCT00063635|P1|Participant Flow|Metformin|Metformin, 500 mg, twice daily
273617|NCT00063635|O3|Outcome|Placebo|Matching placebo
273618|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
273619|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
273620|NCT00063635|O3|Outcome|Placebo|Matching placebo
273621|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
273622|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
273623|NCT00063635|O3|Outcome|Placebo|Matching placebo
273624|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
273625|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
273626|NCT00063635|O3|Outcome|Placebo|Matching placebo
273627|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
273628|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
273629|NCT00063635|O3|Outcome|Placebo|Matching placebo
273630|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
273631|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
273632|NCT00063635|O3|Outcome|Placebo|Matching placebo
273633|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
273634|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
273635|NCT00063635|O3|Outcome|Placebo|Matching placebo
273636|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
273637|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
273638|NCT00063635|O3|Outcome|Placebo|Matching placebo
273639|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
273640|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
273651|NCT00063635|E2|Reported Event|Vitamin E|Vitamin E, 400 IU, twice daily
273652|NCT00063635|E1|Reported Event|Metformin|Metformin, 500 mg, twice daily
273653|NCT00070109|B6|Baseline|Total|Total of all reporting groups
273654|NCT00070109|B5|Baseline|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273655|NCT00070109|B4|Baseline|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273656|NCT00070109|B3|Baseline|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273657|NCT00070109|B2|Baseline|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273658|NCT00070109|B1|Baseline|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
pharmacological study: Correlative studies"
273659|NCT00070109|P5|Participant Flow|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273660|NCT00070109|P4|Participant Flow|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273661|NCT00070109|P3|Participant Flow|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273662|NCT00070109|P2|Participant Flow|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.
trabectedin: Given IV"
273663|NCT00070109|P1|Participant Flow|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level.
trabectedin: Given IV
pharmacological study: Correlative studies"
273664|NCT00070109|O2|Outcome|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.
trabectedin: Given IV"
273665|NCT00070109|O1|Outcome|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
pharmacological study: Correlative studies"
273666|NCT00070109|O4|Outcome|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273667|NCT00070109|O3|Outcome|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273668|NCT00070109|O2|Outcome|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273669|NCT00070109|O1|Outcome|Trabectedin 1.5 mg/m2 to Assess Feasibility|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273670|NCT00070109|E5|Reported Event|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273671|NCT00070109|E4|Reported Event|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273672|NCT00070109|E3|Reported Event|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273673|NCT00070109|E2|Reported Event|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV"
273674|NCT00070109|E1|Reported Event|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
pharmacological study: Correlative studies"
273675|NCT00070135|B1|Baseline|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
273676|NCT00070135|P1|Participant Flow|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
273677|NCT00070135|O1|Outcome|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
273678|NCT00070135|O1|Outcome|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
273679|NCT00070135|O1|Outcome|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
273680|NCT00070135|E1|Reported Event|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.
ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover"
273681|NCT00070291|B1|Baseline|Cyclosporine|
273682|NCT00070291|P1|Participant Flow|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.
High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
273683|NCT00070291|O1|Outcome|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.
High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
273684|NCT00070291|O1|Outcome|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.
High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
273685|NCT00070291|E1|Reported Event|Cyclosporine|High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.
273686|NCT00070499|B5|Baseline|Total|Total of all reporting groups
273687|NCT00070499|B4|Baseline|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
273688|NCT00070499|B3|Baseline|Dasatinib|
273689|NCT00070499|B2|Baseline|High Dose Imatinib|
273690|NCT00070499|B1|Baseline|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
273691|NCT00070499|P4|Participant Flow|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib. Standard dose imatinib was 400 mg daily.
273692|NCT00070499|P3|Participant Flow|Dasatinib|Dasatinib dose was 100 mg daily
273693|NCT00070499|P2|Participant Flow|High Dose Imatinib|High dose imatinib was 800 mg daily.
327285|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
273694|NCT00070499|P1|Participant Flow|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib. Standard dose imatinib was 400 mg daily.
273695|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib B and dasatinib. patients received 400 mg imatinib daily
273696|NCT00070499|O3|Outcome|Dasatinib|Patients received 100 mg dasatinib daily
273697|NCT00070499|O2|Outcome|High Dose Imatinib|Patients received 800 mg imatinib daily
273698|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization occurred between standard dose imatinib A and high dose imatinib. patients received 400 mg imatinib daily
273699|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
273700|NCT00070499|O3|Outcome|Dasatinib|
273701|NCT00070499|O2|Outcome|High Dose Imatinib|
273702|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
273703|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
273704|NCT00070499|O3|Outcome|Dasatinib|
273705|NCT00070499|O2|Outcome|High Dose Imatinib|
273706|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
273707|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
273708|NCT00070499|O3|Outcome|Dasatinib|
273709|NCT00070499|O2|Outcome|High Dose Imatinib|
273710|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
273711|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Standard dose imatinib B
273712|NCT00070499|O3|Outcome|Dasatinib|Dasatinib
273713|NCT00070499|O2|Outcome|High Dose Imatinib|High dose imatinib
273714|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Standard dose imatinib A
273715|NCT00070499|E4|Reported Event|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib B and dasatinib/ patients received 400 mg imatinib daily
273716|NCT00070499|E3|Reported Event|Dasatinib|Patients received 100 mg dasatinib daily
273717|NCT00070499|E2|Reported Event|High Dose Imatinib|Patients received 800 mg imatinib daily
273718|NCT00070499|E1|Reported Event|Standard Dose Imatinib A|Randomization occurred between standard dose imatinib A and high dose imatinib/ patients received 400 mg imatinib daily
273719|NCT00071487|B5|Baseline|Total|Total of all reporting groups
273720|NCT00071487|B4|Baseline|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273721|NCT00071487|B3|Baseline|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273722|NCT00071487|B2|Baseline|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273723|NCT00071487|B1|Baseline|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273724|NCT00071487|P4|Participant Flow|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24 week-open label extension period of the study included patients who completed the 52-week double-blind period and opted to continue in the 24-week open-label period of the study and included patients who were originally randomized to the belimumab 10 mg/kg group in the double-blind period, patients who switched to belimumab 10 mg/kg at the investigator's discretion, and former placebo patients.
273725|NCT00071487|P3|Participant Flow|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
273726|NCT00071487|P2|Participant Flow|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
273727|NCT00071487|P1|Participant Flow|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273728|NCT00071487|O5|Outcome|Open-Label Extension Period: All Active|Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to belimumab 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
273729|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273730|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273731|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273732|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273733|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273734|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273735|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273736|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273737|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273738|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273739|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273740|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273741|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273742|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273743|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273744|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273745|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273746|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273747|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273748|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273749|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273750|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273751|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273752|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273753|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273754|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273755|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273756|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273757|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273758|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273759|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273760|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273761|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273762|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273763|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273764|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
273765|NCT00071487|E5|Reported Event|Open-label Extension Period: All Active|Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
273766|NCT00071487|E4|Reported Event|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
273767|NCT00071487|E3|Reported Event|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
273768|NCT00071487|E2|Reported Event|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
273769|NCT00071487|E1|Reported Event|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
273770|NCT00071513|B3|Baseline|Total|Total of all reporting groups
273771|NCT00071513|B2|Baseline|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.
CAST/HSTS Preventive Intervention: Brief Intervention"
273772|NCT00071513|B1|Baseline|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.
HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.
CAST/HSTS Preventive Intervention: Brief Intervention"
273773|NCT00071513|P2|Participant Flow|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.
CAST/HSTS Preventive Intervention: Brief Intervention"
273774|NCT00071513|P1|Participant Flow|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTS leaders; parents participated in four educational sessions.
HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.
CAST/HSTS Preventive Intervention: Brief Intervention"
273775|NCT00071513|O2|Outcome|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.
Brief Intervention: Assessment of needs and referral to services as needed."
273776|NCT00071513|O1|Outcome|CAST-T/HSTS|"The CAST-T/HSTS condition combined the Brief Intervention and 12 school based small group sessions which taught skills to enhance personal control (to manage depression, anger, stress), self-esteem, decision making and interpersonal communications. HSTS skills groups were held in the spring of 8th grade with 4 one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents also participated in 4 sessions. HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.
CAST-T/HSTS: Skills training small group."
273777|NCT00071513|O2|Outcome|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.
CAST/HSTS Preventive Intervention: Brief Intervention"
273778|NCT00071513|O1|Outcome|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.
HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.
CAST/HSTS Preventive Intervention: Brief Intervention"
273779|NCT00071513|E2|Reported Event|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.
CAST/HSTS Preventive Intervention: Brief Intervention"
273780|NCT00071513|E1|Reported Event|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.
HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.
CAST/HSTS Preventive Intervention: Brief Intervention"
273781|NCT00071721|B3|Baseline|Total|Total of all reporting groups
273782|NCT00071721|B2|Baseline|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
273783|NCT00071721|B1|Baseline|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
273784|NCT00071721|P2|Participant Flow|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
273785|NCT00071721|P1|Participant Flow|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
273786|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
273787|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
273788|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
273789|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
273790|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
273791|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
273792|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
273793|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
273794|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
273795|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
273796|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
273797|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
273798|NCT00071721|E2|Reported Event|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
273799|NCT00071721|E1|Reported Event|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
273800|NCT00071760|B1|Baseline|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273801|NCT00071760|P1|Participant Flow|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273802|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273803|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273870|NCT00071799|O2|Outcome|Best Supportive Care Only|Care can include transfusions, antibiotics, myeloid growth factors [G-CSF and GM CSF] for neutropenic infections until the end of the study.
273804|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273805|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273806|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273807|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273808|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273809|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273810|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273811|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273812|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273813|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273821|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273952|NCT00071890|P2|Participant Flow|Control Group|HAART alone (without Interleukin-2)
273814|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273815|NCT00071760|O3|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and >1 week prior PI therapy [no more than 3 PIs before study enrollment]) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
273816|NCT00071760|O2|Outcome|ART-experienced, PI-naïve FPV/RTV Treatment Group|PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
273817|NCT00071760|O1|Outcome|ART-naïve FPV/RTV Treatment Group|ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
273818|NCT00071760|O3|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and >1 week prior PI therapy [no more than 3 PIs before study enrollment]) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
273819|NCT00071760|O2|Outcome|PI-naïve, ART-experienced FPV/RTV Treatment Group|PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
273820|NCT00071760|O1|Outcome|ART-naïve FPV/RTV Treatment Group|ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
273871|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273872|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273953|NCT00071890|P1|Participant Flow|Interleukin-2 Group|HAART and tree cycles of IL-2
273822|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273823|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273824|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273825|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273826|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273827|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273828|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273829|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273830|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273831|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273832|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273873|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273833|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273834|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273835|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273836|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273837|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273838|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273839|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273850|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273840|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273841|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273842|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273843|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273844|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273845|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273846|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273847|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273848|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273849|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273851|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273852|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273853|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273854|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273855|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273856|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
273857|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273858|NCT00071760|E1|Reported Event|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
273859|NCT00071799|B3|Baseline|Total|Total of all reporting groups
273860|NCT00071799|B2|Baseline|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273861|NCT00071799|B1|Baseline|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273862|NCT00071799|P2|Participant Flow|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273863|NCT00071799|P1|Participant Flow|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273864|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273865|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273866|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273867|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273868|NCT00071799|O4|Outcome|Standard Chemotherapy|Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles – 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
273869|NCT00071799|O3|Outcome|Low-dose Cytarabine|Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
273949|NCT00071890|B3|Baseline|Total|Total of all reporting groups
273874|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273875|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273876|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273877|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273878|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273879|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273880|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273881|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273882|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273883|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273884|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273885|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273886|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273887|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273888|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273889|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273890|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273891|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273892|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273893|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273894|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273895|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273896|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
273897|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273898|NCT00071799|E4|Reported Event|Standard Chemotherapy|Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles - 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
273899|NCT00071799|E3|Reported Event|Low-dose Cytarabine|Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
273900|NCT00071799|E2|Reported Event|Best Supportive Care Only|Care can include transfusions, antibiotics, myeloid growth factors [G-CSF and GM CSF] for neutropenic infections until the end of the study.
273901|NCT00071799|E1|Reported Event|Azacitidine|Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
273902|NCT00071812|B5|Baseline|Total|Total of all reporting groups
273903|NCT00071812|B4|Baseline|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273904|NCT00071812|B3|Baseline|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273905|NCT00071812|B2|Baseline|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273906|NCT00071812|B1|Baseline|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273907|NCT00071812|P4|Participant Flow|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24 week-open label extension period of the study included patients who completed the 24-week double-blind period and opted to continue in the 24-week open-label period of the study and included patients who were originally randomized to the belimumab 10 mg/kg group in the double-blind period, patients who switched to belimumab 10 mg/kg at the investigator's discretion, and former placebo patients.
273908|NCT00071812|P3|Participant Flow|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 24-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
273950|NCT00071890|B2|Baseline|Control Group|HAART alone (without Interleukin-2)
273951|NCT00071890|B1|Baseline|Interleukin-2 Group|HAART and tree cycles of IL-2
273909|NCT00071812|P2|Participant Flow|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 24-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
273910|NCT00071812|P1|Participant Flow|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study.
273911|NCT00071812|O5|Outcome|Open-label Extension Period: All Active|Includes all patients who completed the 24-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
273912|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273913|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273914|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273915|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273916|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273917|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273918|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273919|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273920|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273921|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273922|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273923|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273924|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273925|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273926|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273927|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273928|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273929|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273930|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273931|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273932|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273933|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273934|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273935|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273936|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273937|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273938|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273939|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273940|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273941|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273942|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273943|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273944|NCT00071812|E5|Reported Event|Open-label Extension Period: All Active|Includes all patients who completed the 24-week double blind period and opted to continue in the 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
273945|NCT00071812|E4|Reported Event|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273946|NCT00071812|E3|Reported Event|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273947|NCT00071812|E2|Reported Event|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273948|NCT00071812|E1|Reported Event|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
273954|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
273955|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
273956|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
273957|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
273958|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
273959|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
273960|NCT00071890|E2|Reported Event|Control Group|HAART alone (without Interleukin-2)
273961|NCT00071890|E1|Reported Event|Interleukin-2 Group|HAART and tree cycles of IL-2
273962|NCT00071981|B5|Baseline|Total|Total of all reporting groups
273963|NCT00071981|B4|Baseline|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273964|NCT00071981|B3|Baseline|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273965|NCT00071981|B2|Baseline|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection"
273966|NCT00071981|B1|Baseline|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection"
273967|NCT00071981|P4|Participant Flow|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273968|NCT00071981|P3|Participant Flow|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273969|NCT00071981|P2|Participant Flow|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection"
273970|NCT00071981|P1|Participant Flow|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection"
273971|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273972|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273973|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection"
273974|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection"
274106|NCT00073021|P2|Participant Flow|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
273975|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273976|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273977|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection"
273978|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection"
273979|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273980|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273981|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection"
273982|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection"
273983|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273984|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273985|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection"
273986|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection"
273987|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273988|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
274268|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
274269|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
273989|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection"
273990|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection"
273991|NCT00071981|E4|Reported Event|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273992|NCT00071981|E3|Reported Event|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
melanoma helper peptide vaccine : Given by injection"
273993|NCT00071981|E2|Reported Event|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection
tetanus peptide melanoma vaccine : Given by injection"
273994|NCT00071981|E1|Reported Event|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
multi-epitope melanoma peptide vaccine : Given by injection
incomplete Freund's adjuvant : Given by injection
sargramostim : Given by injection"
273995|NCT00072176|B3|Baseline|Total|Total of all reporting groups
273996|NCT00072176|B2|Baseline|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
273997|NCT00072176|B1|Baseline|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
273998|NCT00072176|P2|Participant Flow|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
273999|NCT00072176|P1|Participant Flow|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
274000|NCT00072176|O2|Outcome|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
274001|NCT00072176|O1|Outcome|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
274002|NCT00072176|O2|Outcome|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
274003|NCT00072176|O1|Outcome|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
274004|NCT00072176|E2|Reported Event|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
274005|NCT00072176|E1|Reported Event|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
274006|NCT00072189|B1|Baseline|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
274007|NCT00072189|P1|Participant Flow|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
274030|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
Axillary lymph node dissection: Axillary lymph node dissection"
274270|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
274008|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
274009|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
274010|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
274011|NCT00072189|E1|Reported Event|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
274012|NCT00072280|B3|Baseline|Total|Total of all reporting groups
274013|NCT00072280|B2|Baseline|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
274014|NCT00072280|B1|Baseline|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.
(See Interventions section for drug dosage and administration details.)"
274015|NCT00072280|P2|Participant Flow|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
274016|NCT00072280|P1|Participant Flow|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.
(See Interventions section for drug dosage and administration details.)"
274017|NCT00072280|O1|Outcome|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.
(See Interventions section for drug dosage and administration details.)"
274018|NCT00072280|E2|Reported Event|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
274019|NCT00072280|E1|Reported Event|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.
(See Interventions section for drug dosage and administration details.)"
274020|NCT00072293|B3|Baseline|Total|Total of all reporting groups
274021|NCT00072293|B2|Baseline|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
No axillary lymph node dissection: Therapeutic conventional surgery"
274022|NCT00072293|B1|Baseline|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
Axillary lymph node dissection: Axillary lymph node dissection"
274023|NCT00072293|P2|Participant Flow|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
No axillary lymph node dissection: Therapeutic conventional surgery"
274024|NCT00072293|P1|Participant Flow|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
Axillary lymph node dissection: Axillary lymph node dissection"
274025|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
No axillary lymph node dissection: Therapeutic conventional surgery"
274026|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
Axillary lymph node dissection: Axillary lymph node dissection"
274027|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
No axillary lymph node dissection: Therapeutic conventional surgery"
274028|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
Axillary lymph node dissection: Axillary lymph node dissection"
274029|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
No axillary lymph node dissection: Therapeutic conventional surgery"
274105|NCT00073021|B1|Baseline|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274031|NCT00072293|E2|Reported Event|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
No axillary lymph node dissection: Therapeutic conventional surgery"
274032|NCT00072293|E1|Reported Event|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
Axillary lymph node dissection: Axillary lymph node dissection"
274033|NCT00072449|B1|Baseline|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
274034|NCT00072449|P1|Participant Flow|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
274035|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
274036|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
274037|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
274038|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
274039|NCT00072449|E1|Reported Event|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
274040|NCT00072475|B1|Baseline|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.
vatalanib: Pts registered before 1/15/05 1250 mg/day PO
After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
274041|NCT00072475|P1|Participant Flow|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.
vatalanib: Pts registered before 1/15/05 1250 mg/day PO
After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
274042|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.
vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
274043|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.
vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
274044|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.
vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
274045|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.
vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
274046|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.
vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
274047|NCT00072475|E1|Reported Event|Vatalanib|After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
274048|NCT00072514|B1|Baseline|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
274049|NCT00072514|P1|Participant Flow|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
274050|NCT00072514|O1|Outcome|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
274051|NCT00072514|O1|Outcome|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
274052|NCT00072514|O1|Outcome|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
274053|NCT00072514|O1|Outcome|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
274054|NCT00072514|E1|Reported Event|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
274055|NCT00072566|B1|Baseline|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
cyclophosphamide: Given PO"
274271|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
274272|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
274056|NCT00072566|P1|Participant Flow|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
cyclophosphamide: Given PO"
274057|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
cyclophosphamide: Given PO"
274058|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
cyclophosphamide: Given PO"
274059|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
cyclophosphamide: Given PO"
274060|NCT00072566|E1|Reported Event|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
cyclophosphamide: Given PO"
274061|NCT00072761|B3|Baseline|Total|Total of all reporting groups
274062|NCT00072761|B2|Baseline|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
274063|NCT00072761|B1|Baseline|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
274064|NCT00072761|P2|Participant Flow|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
274065|NCT00072761|P1|Participant Flow|Transfusion Group|The transfusion group received blood transfusion therapy every 4-6 weeks for 36 months.
274066|NCT00072761|O2|Outcome|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
274067|NCT00072761|O1|Outcome|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
274068|NCT00072761|E2|Reported Event|Observation Group|The observation Group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
274069|NCT00072761|E1|Reported Event|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
274070|NCT00073008|B3|Baseline|Total|Total of all reporting groups
274071|NCT00073008|B2|Baseline|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274072|NCT00073008|B1|Baseline|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274073|NCT00073008|P2|Participant Flow|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274074|NCT00073008|P1|Participant Flow|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274075|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274076|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274077|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274078|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274079|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274080|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274081|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274082|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274083|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274084|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274085|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274086|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274087|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274088|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274089|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274090|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274091|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274092|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274093|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274094|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274095|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274096|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274097|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274098|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274099|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274100|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274101|NCT00073008|E2|Reported Event|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
274102|NCT00073008|E1|Reported Event|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
274103|NCT00073021|B3|Baseline|Total|Total of all reporting groups
274104|NCT00073021|B2|Baseline|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274107|NCT00073021|P1|Participant Flow|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274108|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274109|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274110|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274111|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274112|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274113|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274114|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274115|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274116|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274117|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274118|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274119|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274120|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274121|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274122|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274123|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274124|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274125|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274126|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274127|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274128|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274129|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274130|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274131|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274132|NCT00073021|E2|Reported Event|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
274133|NCT00073021|E1|Reported Event|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
274134|NCT00073073|B1|Baseline|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.
Exemestane: exemestane 25 mg by mouth (PO) every day for two years
Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years
Vitamin D: Vitamin D 400 international units PO every day x 2 years"
274135|NCT00073073|P1|Participant Flow|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.
Exemestane: exemestane 25 mg by mouth (PO) every day for two years
Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years
Vitamin D: Vitamin D 400 international units PO every day x 2 years"
274136|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.
Exemestane: exemestane 25 mg by mouth (PO) every day for two years
Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years
Vitamin D: Vitamin D 400 international units PO every day x 2 years"
274137|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.
Exemestane: exemestane 25 mg by mouth (PO) every day for two years
Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years
Vitamin D: Vitamin D 400 international units PO every day x 2 years"
274273|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
274274|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
274138|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.
Exemestane: exemestane 25 mg by mouth (PO) every day for two years
Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years
Vitamin D: Vitamin D 400 international units PO every day x 2 years"
274139|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.
Exemestane: exemestane 25 mg by mouth (PO) every day for two years
Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years
Vitamin D: Vitamin D 400 international units PO every day x 2 years"
274140|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.
Exemestane: exemestane 25 mg by mouth (PO) every day for two years
Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years
Vitamin D: Vitamin D 400 international units PO every day x 2 years"
274141|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.
Exemestane: exemestane 25 mg by mouth (PO) every day for two years
Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years
Vitamin D: Vitamin D 400 international units PO every day x 2 years"
274142|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.
Exemestane: exemestane 25 mg by mouth (PO) every day for two years
Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years
Vitamin D: Vitamin D 400 international units PO every day x 2 years"
274143|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.
Exemestane: exemestane 25 mg by mouth (PO) every day for two years
Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years
Vitamin D: Vitamin D 400 international units PO every day x 2 years"
274144|NCT00073073|E1|Reported Event|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.
Exemestane: exemestane 25 mg by mouth (PO) every day for two years
Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years
Vitamin D: Vitamin D 400 international units PO every day x 2 years"
274145|NCT00073307|B3|Baseline|Total|Total of all reporting groups
274146|NCT00073307|B2|Baseline|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
274147|NCT00073307|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
274148|NCT00073307|P3|Participant Flow|Placebo Randomized, Switch to Sorafenib; Sorafenib Period Only|Subjects received matching placebo tablets administered orally twice a day(as of ~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily).
274149|NCT00073307|P2|Participant Flow|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
274150|NCT00073307|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily).
274151|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
274152|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
274153|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
274154|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
274155|NCT00073307|O2|Outcome|Placebo|Placebo tablets matching in appearance were to be orally administered twice a day.
274156|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
274157|NCT00073307|O2|Outcome|Placebo|Placebo tablets matching in appearance were to be orally administered twice a day.
274158|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
274159|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
274160|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
274161|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
274162|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
274163|NCT00073307|E4|Reported Event|Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008|Sorafenib period only-30Jun2008: Subjects received matching placebo tablets administered orally twice a day(as of ~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily). Open Label/Sorafenib only period-30Jun2008
274275|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
274164|NCT00073307|E3|Reported Event|Sorafenib (Nexavar, BAY43-9006)-30Jun2008|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind-30Jun2008. In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the open-label/Sorafenib only phase and was included in the safety population only. Participants affected may deviate from double-blind phase due to data update and cleaning.
274165|NCT00073307|E2|Reported Event|Placebo-31May2005 DB|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
274166|NCT00073307|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)-31May2005 DB|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind period-31May2005
274167|NCT00073333|B4|Baseline|Total|Total of all reporting groups
274168|NCT00073333|B3|Baseline|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
274169|NCT00073333|B2|Baseline|2Imaginal and in Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
274170|NCT00073333|B1|Baseline|1Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
274171|NCT00073333|P3|Participant Flow|3Attention Placebo|Placebo - attention placebo control condition consisting of weekly telephone contact of ten minutes during which clinical status, particularly level of depression was assessed. There was no other contact
274172|NCT00073333|P2|Participant Flow|2Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week for entire study. Imaginal was instituted first followed by in vivo exposure in the form of programmed practice
274173|NCT00073333|P1|Participant Flow|1Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week. Social Skills was conducted in groups of 4-6 participants. Exposure was individual therapy conducted weekly.
274174|NCT00073333|O3|Outcome|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
274175|NCT00073333|O2|Outcome|Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
274176|NCT00073333|O1|Outcome|Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
274177|NCT00073333|E3|Reported Event|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
274178|NCT00073333|E2|Reported Event|Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
274179|NCT00073333|E1|Reported Event|Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
274180|NCT00073528|B3|Baseline|Total|Total of all reporting groups
274181|NCT00073528|B2|Baseline|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274182|NCT00073528|B1|Baseline|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274183|NCT00073528|P2|Participant Flow|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274184|NCT00073528|P1|Participant Flow|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274185|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274186|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274187|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274188|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274189|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274276|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
274190|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274191|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274192|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274193|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274194|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274195|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274196|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274197|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274198|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274199|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274200|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274201|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274202|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274203|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274204|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274205|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274277|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
274206|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274207|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274208|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274209|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274210|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274211|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274212|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274213|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274214|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274215|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274216|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274217|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274218|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274219|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274220|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274221|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
327631|NCT00279955|B4|Baseline|Total|Total of all reporting groups
274222|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274223|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274224|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274225|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274226|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274227|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274228|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274229|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274230|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274231|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274232|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274233|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274234|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274235|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274236|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274237|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
328395|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
274238|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274239|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274240|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274241|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274242|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274243|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274244|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274245|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274246|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274247|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274248|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274249|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274250|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274251|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274252|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274253|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
328396|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
274254|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274255|NCT00073528|E2|Reported Event|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274256|NCT00073528|E1|Reported Event|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
274257|NCT00073918|B1|Baseline|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
274258|NCT00073918|P1|Participant Flow|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
274259|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
274260|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
274261|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
274262|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
274263|NCT00073918|E1|Reported Event|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
274264|NCT00073983|B1|Baseline|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
274265|NCT00073983|P1|Participant Flow|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
274266|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
274267|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
274278|NCT00073983|E1|Reported Event|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
274279|NCT00074035|B1|Baseline|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
274280|NCT00074035|P1|Participant Flow|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
274281|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
274282|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
274283|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
274284|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
274285|NCT00074035|E1|Reported Event|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
274286|NCT00066807|B3|Baseline|Total|Total of all reporting groups
274287|NCT00066807|B2|Baseline|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274288|NCT00066807|B1|Baseline|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274289|NCT00066807|P2|Participant Flow|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274290|NCT00066807|P1|Participant Flow|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274291|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274292|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274293|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274294|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274295|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274296|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274297|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274298|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274299|NCT00066807|E2|Reported Event|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274300|NCT00066807|E1|Reported Event|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
274301|NCT00066937|B5|Baseline|Total|Total of all reporting groups
274302|NCT00066937|B4|Baseline|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
274303|NCT00066937|B3|Baseline|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
274304|NCT00066937|B2|Baseline|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
274305|NCT00066937|B1|Baseline|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
274306|NCT00066937|P4|Participant Flow|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
274307|NCT00066937|P3|Participant Flow|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
274308|NCT00066937|P2|Participant Flow|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
274309|NCT00066937|P1|Participant Flow|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
274310|NCT00066937|O4|Outcome|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
274311|NCT00066937|O3|Outcome|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
274312|NCT00066937|O2|Outcome|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
274313|NCT00066937|O1|Outcome|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
274314|NCT00066937|O4|Outcome|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
274315|NCT00066937|O3|Outcome|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
274316|NCT00066937|O2|Outcome|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
274317|NCT00066937|O1|Outcome|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
274318|NCT00066937|O4|Outcome|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
274319|NCT00066937|O3|Outcome|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
274320|NCT00066937|O2|Outcome|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
274321|NCT00066937|O1|Outcome|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
274322|NCT00066937|O4|Outcome|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
274323|NCT00066937|O3|Outcome|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
274324|NCT00066937|O2|Outcome|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
274325|NCT00066937|O1|Outcome|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
274326|NCT00066937|E4|Reported Event|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
274327|NCT00066937|E3|Reported Event|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
274328|NCT00066937|E2|Reported Event|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
274329|NCT00066937|E1|Reported Event|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
274330|NCT00066963|B4|Baseline|Total|Total of all reporting groups
274331|NCT00066963|B3|Baseline|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
274332|NCT00066963|B2|Baseline|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
274333|NCT00066963|B1|Baseline|No Intervention: Counseling Only|Counseling Only (0FV)
274334|NCT00066963|P3|Participant Flow|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
274335|NCT00066963|P2|Participant Flow|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
274336|NCT00066963|P1|Participant Flow|No Intervention: Counseling Only|Counseling Only (0FV)
274337|NCT00066963|O3|Outcome|FV 2x/Year + Counseling|fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) twice per year for 2 years (every 6 months)
274338|NCT00066963|O2|Outcome|FV 1x/Year + Counseling|fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) once per year for 2 years (every 12 months) plus caregiver counseling
274339|NCT00066963|O1|Outcome|Counseling Only|caregiver counseling only (zero fluoride varnish)
274340|NCT00066963|E3|Reported Event|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
274341|NCT00066963|E2|Reported Event|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
274342|NCT00066963|E1|Reported Event|No Intervention: Counseling Only|Counseling Only (0FV)
274343|NCT00067236|B3|Baseline|Total|Total of all reporting groups
274344|NCT00067236|B2|Baseline|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
274345|NCT00067236|B1|Baseline|Placebo|Placebo tablet twice daily for 90 days
274346|NCT00067236|P2|Participant Flow|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
274347|NCT00067236|P1|Participant Flow|Placebo|Placebo tablet twice daily for 90 days
274348|NCT00067236|O2|Outcome|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
274349|NCT00067236|O1|Outcome|Placebo|Placebo tablet twice daily for 90 days
274350|NCT00067236|E2|Reported Event|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
274351|NCT00067236|E1|Reported Event|Placebo|Placebo tablet twice daily for 90 days
274352|NCT00074152|B3|Baseline|Total|Total of all reporting groups
274353|NCT00074152|B2|Baseline|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.
chemotherapy: Given within 10 weeks after surgery."
274354|NCT00074152|B1|Baseline|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.
radiation therapy: Given within 6 months after surgery"
274355|NCT00074152|P2|Participant Flow|Chemotherapy|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.
chemotherapy: Given within 10 weeks after surgery."
274356|NCT00074152|P1|Participant Flow|Observation|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.
radiation therapy: Given within 6 months after surgery"
274357|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.
chemotherapy: Given within 10 weeks after surgery."
274358|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation).Patients receive radiotherapy* within 6 months after surgery.
radiation therapy: Given within 6 months after surgery"
274359|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.
chemotherapy: Given within 10 weeks after surgery."
274360|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation).Patients receive radiotherapy* within 6 months after surgery.
radiation therapy: Given within 6 months after surgery"
274361|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.
chemotherapy: Given within 10 weeks after surgery."
274362|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.
radiation therapy: Given within 6 months after surgery"
274363|NCT00074152|E2|Reported Event|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.
chemotherapy: Given within 10 weeks after surgery."
274364|NCT00074152|E1|Reported Event|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.
radiation therapy: Given within 6 months after surgery"
274365|NCT00074165|B1|Baseline|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
274366|NCT00074165|P1|Participant Flow|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
274367|NCT00074165|O1|Outcome|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
274368|NCT00074165|O1|Outcome|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
274369|NCT00074165|E1|Reported Event|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
274370|NCT00074269|B1|Baseline|Pilot Study of Allogeneic Transplant for Metastatic Breast Can|"anti-thymocyte globulin
filgrastim
graft-versus-tumor induction therapy
therapeutic allogeneic lymphocytes
cyclosporine
fludarabine phosphate
melphalan
methotrexate
peripheral blood stem cell transplantation"
274371|NCT00074269|P1|Participant Flow|Treatment|"anti-thymocyte globulin
filgrastim
graft-versus-tumor induction therapy
therapeutic allogeneic lymphocytes
cyclosporine
fludarabine phosphate
melphalan
methotrexate
peripheral blood stem cell transplantation"
274372|NCT00074269|O1|Outcome|Treatment|"Toxicity
anti-thymocyte globulin
filgrastim
graft-versus-tumor induction therapy
therapeutic allogeneic lymphocytes
cyclosporine
fludarabine phosphate
melphalan
methotrexate
peripheral blood stem cell transplantation"
274373|NCT00074269|E1|Reported Event|Treatment|"incidence of Toxicity
administration of filgrastim
Grade of GVHD
Initiation of graft-versus-tumor induction therapy
Disease Status"
274374|NCT00074412|B3|Baseline|Total|Total of all reporting groups
274375|NCT00074412|B2|Baseline|Placebo|For infants: extended treatment with NVP placebo
274376|NCT00074412|B1|Baseline|Nevirapine|For infants: extended treatment with NVP
274377|NCT00074412|P2|Participant Flow|Nevirapine|For infants: extended treatment with NVP
274378|NCT00074412|P1|Participant Flow|Placebo|For infants: extended treatment with NVP placebo
274379|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
274380|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
274381|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
274382|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
274383|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
274384|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
274385|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
274386|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
274387|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP Placebo
274388|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
274389|NCT00074412|E2|Reported Event|Placebo|For infants: extended treatment with NVP placebo
274390|NCT00074412|E1|Reported Event|Nevirapine|For infants: extended treatment with NVP
274391|NCT00074802|B3|Baseline|Total|Total of all reporting groups
274392|NCT00074802|B2|Baseline|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
274393|NCT00074802|B1|Baseline|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
274394|NCT00074802|P2|Participant Flow|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
274395|NCT00074802|P1|Participant Flow|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
274396|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
274397|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
274398|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
274399|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
274400|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
274401|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
274402|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
274403|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
274404|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
274405|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
274406|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
274407|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
274408|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
274409|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
274410|NCT00074802|E2|Reported Event|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
274411|NCT00074802|E1|Reported Event|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
274412|NCT00074815|B4|Baseline|Total|Total of all reporting groups
274413|NCT00074815|B3|Baseline|MM Only|Participants will receive medication management only
274414|NCT00074815|B2|Baseline|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
274415|NCT00074815|B1|Baseline|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
274416|NCT00074815|P3|Participant Flow|MM Only|Participants will receive medication management only
274417|NCT00074815|P2|Participant Flow|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
274418|NCT00074815|P1|Participant Flow|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
274419|NCT00074815|O3|Outcome|MM Only|Participants will receive medication management only
274420|NCT00074815|O2|Outcome|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
274421|NCT00074815|O1|Outcome|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
274422|NCT00074815|E3|Reported Event|MM Only|Participants will receive medication management only
274423|NCT00074815|E2|Reported Event|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
274424|NCT00074815|E1|Reported Event|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
274425|NCT00074958|B1|Baseline|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
274426|NCT00074958|P1|Participant Flow|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
274427|NCT00074958|O1|Outcome|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
274428|NCT00074958|O1|Outcome|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
274429|NCT00074958|E1|Reported Event|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
274430|NCT00074984|B3|Baseline|Total|Total of all reporting groups
274431|NCT00074984|B2|Baseline|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
274432|NCT00074984|B1|Baseline|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
274433|NCT00074984|P2|Participant Flow|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
274434|NCT00074984|P1|Participant Flow|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
274435|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
274436|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
274437|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
274438|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
274439|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
274440|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
274441|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
274442|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
274443|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
274444|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
274445|NCT00074984|E3|Reported Event|Total|All patients.
274446|NCT00074984|E2|Reported Event|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks
274447|NCT00074984|E1|Reported Event|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme(agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
274448|NCT00075023|B3|Baseline|Total|Total of all reporting groups
274449|NCT00075023|B2|Baseline|Placebo|Placebo Gel
274450|NCT00075023|B1|Baseline|Thalidomide Gel|Thalidomide Gel
274451|NCT00075023|P2|Participant Flow|Placebo|Placebo Gel
274452|NCT00075023|P1|Participant Flow|Thalidomide Gel|Thalidomide Gel
274453|NCT00075023|O2|Outcome|Placebo|Placebo Gel
274454|NCT00075023|O1|Outcome|Thalidomide Gel|Thalidomide Gel
274455|NCT00075023|E3|Reported Event|Adverse Events for All Participants|These are adverse events for participants as reported to the DSMB, without information related to treatment arm
274456|NCT00075023|E2|Reported Event|Placebo|Placebo Gel
274457|NCT00075023|E1|Reported Event|Thalidomide Gel|Thalidomide Gel
274458|NCT00075088|B3|Baseline|Total|Total of all reporting groups
274459|NCT00075088|B2|Baseline|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
274460|NCT00075088|B1|Baseline|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
274461|NCT00075088|P2|Participant Flow|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
274462|NCT00075088|P1|Participant Flow|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
274463|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
274464|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
274465|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
274466|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
274467|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
274468|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
274469|NCT00075088|E3|Reported Event|Prehospital|"At the start of the trial, the IRB requested every death in the pre-hospital period be reported because we put on the study electrocardiogram device in the field with waiver of consent so as not to cause a delay for patients reaching the hospital with possible heart attack. They were consented after they reached the hospital. However, IRB removed this requirement after 40 pre-consent/pre-hospital deaths were reported. The number of pre-hospital participants assessed before and after the IRB changed the reporting requirements cannot be determined from study data, but NA is not a valid entry in the At Risk field."
274470|NCT00075088|E2|Reported Event|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
274471|NCT00075088|E1|Reported Event|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
274472|NCT00075218|B3|Baseline|Total|Total of all reporting groups
274473|NCT00075218|B2|Baseline|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274474|NCT00075218|B1|Baseline|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274475|NCT00075218|P3|Participant Flow|Sunitinib Open-Label Treatment|Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
274476|NCT00075218|P2|Participant Flow|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274477|NCT00075218|P1|Participant Flow|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274478|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274479|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274480|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274481|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274482|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274483|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274484|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274485|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274791|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274486|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274487|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274488|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274489|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274490|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274491|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274492|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274493|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274494|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274495|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274496|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274497|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274498|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274499|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274500|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274501|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274502|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274503|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274774|NCT00075816|P2|Participant Flow|Peripheral-Blood Stem Cells|Patients who underwent transplantation of peripheral-blood stem cells from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
328397|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
274504|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274505|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274506|NCT00075218|E3|Reported Event|Sunitinib Open-Label Treatment|Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
274507|NCT00075218|E2|Reported Event|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
274508|NCT00075218|E1|Reported Event|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
274509|NCT00075270|B3|Baseline|Total|Total of all reporting groups
274510|NCT00075270|B2|Baseline|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274511|NCT00075270|B1|Baseline|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274512|NCT00075270|P2|Participant Flow|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274513|NCT00075270|P1|Participant Flow|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274514|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274515|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274516|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274517|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274518|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274519|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274520|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274521|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274522|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274523|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274795|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274524|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274525|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274526|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274527|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274528|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274529|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274530|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274531|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274532|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274533|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274534|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274535|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274536|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274537|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274538|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274539|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274540|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274541|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274542|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274543|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274792|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274544|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274545|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274546|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274547|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274548|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274549|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274550|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274551|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274552|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274553|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274554|NCT00075270|E2|Reported Event|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274555|NCT00075270|E1|Reported Event|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
274556|NCT00075400|B1|Baseline|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
274557|NCT00075400|P1|Participant Flow|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
274558|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
274559|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
274560|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
274561|NCT00075400|E1|Reported Event|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
274562|NCT00075478|B3|Baseline|Total|Total of all reporting groups
274563|NCT00075478|B2|Baseline|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274793|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274564|NCT00075478|B1|Baseline|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274565|NCT00075478|P2|Participant Flow|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274566|NCT00075478|P1|Participant Flow|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274567|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274568|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274569|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274570|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274571|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274572|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274573|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274574|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274575|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274576|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274577|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274578|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274579|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274580|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274581|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274794|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274582|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274583|NCT00075478|E2|Reported Event|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274584|NCT00075478|E1|Reported Event|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation"
274585|NCT00075504|B3|Baseline|Total|Total of all reporting groups
274586|NCT00075504|B2|Baseline|Stratum B Abnormal Liver Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274587|NCT00075504|B1|Baseline|Stratum A Normal Liver Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274588|NCT00075504|P2|Participant Flow|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274589|NCT00075504|P1|Participant Flow|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274590|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274591|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274592|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274593|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274594|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274595|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274596|NCT00075504|E2|Reported Event|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274597|NCT00075504|E1|Reported Event|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV"
274598|NCT00075582|B3|Baseline|Total|Total of all reporting groups
274599|NCT00075582|B2|Baseline|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy"
274600|NCT00075582|B1|Baseline|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy"
274775|NCT00075816|P1|Participant Flow|Bone Marrow|Patients who underwent transplantation of bone marrow from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
274601|NCT00075582|P2|Participant Flow|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy"
274602|NCT00075582|P1|Participant Flow|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy"
274603|NCT00075582|O1|Outcome|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy"
274604|NCT00075582|O1|Outcome|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy"
274605|NCT00075582|O2|Outcome|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy"
274606|NCT00075582|O1|Outcome|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy"
274607|NCT00075582|E2|Reported Event|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy"
274608|NCT00075582|E1|Reported Event|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy"
274609|NCT00075608|B1|Baseline|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
274610|NCT00075608|P1|Participant Flow|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
274611|NCT00075608|O1|Outcome|2nd SCT|"Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning
filgrastim: 16mcg/kg IV daily beginning three days prior to SCC through last day of SCC
melphalan: 140-200 mcg/kg IV over two days
autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0
peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0"
274776|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
274777|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
328398|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
274612|NCT00075608|O1|Outcome|2nd SCT|"Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning
filgrastim: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of SCC
melphalan: 140-200 mcg/kg IV over two days
autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0
peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0"
274613|NCT00075608|O1|Outcome|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
274614|NCT00075608|E1|Reported Event|Second Transplant|Participants who received a second transplant
274615|NCT00075725|B13|Baseline|Total|Total of all reporting groups
274616|NCT00075725|B12|Baseline|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth
274617|NCT00075725|B11|Baseline|Dexamethasone, Capizzi Methotrexate Down Syndrome|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274618|NCT00075725|B10|Baseline|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274619|NCT00075725|B9|Baseline|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274620|NCT00075725|B8|Baseline|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274621|NCT00075725|B7|Baseline|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274622|NCT00075725|B6|Baseline|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274623|NCT00075725|B5|Baseline|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274778|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274779|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274624|NCT00075725|B4|Baseline|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274625|NCT00075725|B3|Baseline|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274626|NCT00075725|B2|Baseline|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274627|NCT00075725|B1|Baseline|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274628|NCT00075725|P12|Participant Flow|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274629|NCT00075725|P11|Participant Flow|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274630|NCT00075725|P10|Participant Flow|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274631|NCT00075725|P9|Participant Flow|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274632|NCT00075725|P8|Participant Flow|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274633|NCT00075725|P7|Participant Flow|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH (Prednisone, High Dose MTX) regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274634|NCT00075725|P6|Participant Flow|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274635|NCT00075725|P5|Participant Flow|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC (Prednisone, Capizzi) will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274636|NCT00075725|P4|Participant Flow|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274637|NCT00075725|P3|Participant Flow|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274638|NCT00075725|P2|Participant Flow|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH (High Dose) regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274639|NCT00075725|P1|Participant Flow|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274640|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274641|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274780|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274781|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274782|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274783|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
328399|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
274642|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274643|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274644|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274645|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274646|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274647|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274648|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274649|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274650|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274784|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
274785|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
274651|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274652|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274653|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274654|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274655|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274656|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274657|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274658|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274659|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274786|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
274787|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
274660|NCT00075725|O12|Outcome|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274661|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274662|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274663|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274664|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274665|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274666|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274667|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274668|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274788|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
328400|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
274669|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274670|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274671|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274672|NCT00075725|O12|Outcome|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274673|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274674|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274675|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274676|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274677|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274789|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274678|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274679|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274680|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274681|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274682|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274683|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274684|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274685|NCT00075725|O10|Outcome|Prednisone, Capizzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274686|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274705|NCT00075725|O10|Outcome|Prenisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274687|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274688|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274689|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274690|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274691|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274692|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274693|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274694|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274695|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274764|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
274765|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
274766|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
274696|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274697|NCT00075725|O7|Outcome|Predisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274698|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274699|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274700|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274701|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274702|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274703|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274704|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274767|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
274768|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
274769|NCT00075803|E2|Reported Event|Voriconazole|voriconazole prophylaxis
274770|NCT00075803|E1|Reported Event|Fluconazole|fluconazole prophylaxis
274771|NCT00075816|B3|Baseline|Total|Total of all reporting groups
328401|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
274706|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274707|NCT00075725|O8|Outcome|Prenisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274708|NCT00075725|O7|Outcome|Predisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274709|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274710|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274711|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274712|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274713|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274714|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274772|NCT00075816|B2|Baseline|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274773|NCT00075816|B1|Baseline|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274715|NCT00075725|E12|Reported Event|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274716|NCT00075725|E11|Reported Event|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274717|NCT00075725|E10|Reported Event|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274718|NCT00075725|E9|Reported Event|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274719|NCT00075725|E8|Reported Event|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274720|NCT00075725|E7|Reported Event|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274721|NCT00075725|E6|Reported Event|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274722|NCT00075725|E5|Reported Event|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
274723|NCT00075725|E4|Reported Event|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274790|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274724|NCT00075725|E3|Reported Event|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274725|NCT00075725|E2|Reported Event|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274726|NCT00075725|E1|Reported Event|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
274727|NCT00075764|B3|Baseline|Total|Total of all reporting groups
274728|NCT00075764|B2|Baseline|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly"
274729|NCT00075764|B1|Baseline|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally"
274730|NCT00075764|P2|Participant Flow|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly"
274731|NCT00075764|P1|Participant Flow|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally"
274732|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
274733|NCT00075764|O1|Outcome|Arm I Anastrozole|Patients receive oral anastrozole once daily on days 1-28
274734|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly"
274735|NCT00075764|O1|Outcome|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally"
274736|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly"
274737|NCT00075764|O1|Outcome|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally"
274738|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly"
274739|NCT00075764|O1|Outcome|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally"
274740|NCT00075764|E2|Reported Event|Anastrozole & Fulvestrant|Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
274741|NCT00075764|E1|Reported Event|Anastrozole|Patients receive oral anastrozole once daily on days 1-28
274742|NCT00075803|B3|Baseline|Total|Total of all reporting groups
274743|NCT00075803|B2|Baseline|Voriconazole|voriconazole prophylaxis
274744|NCT00075803|B1|Baseline|Fluconazole|fluconazole prophylaxis
274745|NCT00075803|P2|Participant Flow|Voriconazole|voriconazole prophylaxis
274746|NCT00075803|P1|Participant Flow|Fluconazole|fluconazole prophylaxis
274747|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
274748|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
274749|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
274750|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
274751|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
274752|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
274753|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
274754|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
274755|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
274756|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
274757|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
274758|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
274759|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
274760|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
274761|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
274762|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
274763|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
274796|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274797|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274798|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274799|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274800|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
274801|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
274802|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274803|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274804|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274805|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274806|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274807|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274808|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274809|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274810|NCT00075816|E2|Reported Event|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
274811|NCT00075816|E1|Reported Event|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
274812|NCT00075829|B5|Baseline|Total|Total of all reporting groups
274813|NCT00075829|B4|Baseline|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
274814|NCT00075829|B3|Baseline|Auto-Auto High Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients
PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
274815|NCT00075829|B2|Baseline|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
274816|NCT00075829|B1|Baseline|Auto-Auto Standard Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients
PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
274817|NCT00075829|P4|Participant Flow|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
274818|NCT00075829|P3|Participant Flow|Auto-Auto High Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients
PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
274819|NCT00075829|P2|Participant Flow|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
274820|NCT00075829|P1|Participant Flow|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.
274821|NCT00075829|O1|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
274822|NCT00075829|O1|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
274823|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
274824|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
274825|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
274826|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
274827|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
274828|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
274829|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
274830|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
274831|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
274832|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
274833|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
274834|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
274835|NCT00075829|O2|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
274836|NCT00075829|O1|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
274837|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
274838|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
274839|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
274840|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
328402|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
274841|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
274842|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
274843|NCT00075829|E4|Reported Event|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
274844|NCT00075829|E3|Reported Event|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
274845|NCT00075829|E2|Reported Event|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
274846|NCT00075829|E1|Reported Event|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
274847|NCT00075881|B1|Baseline|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
274848|NCT00075881|P1|Participant Flow|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
274849|NCT00075881|O1|Outcome|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
274850|NCT00075881|O1|Outcome|PS-341|Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose
274851|NCT00075881|O1|Outcome|PS-341|Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15
274852|NCT00075881|O1|Outcome|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
274853|NCT00075881|E1|Reported Event|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.
Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.
Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
274854|NCT00075946|B5|Baseline|Total|Total of all reporting groups
274855|NCT00075946|B4|Baseline|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
274856|NCT00075946|B3|Baseline|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
274857|NCT00075946|B2|Baseline|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
274858|NCT00075946|B1|Baseline|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
274859|NCT00075946|P5|Participant Flow|Enrolled But Not Randomized|Patients who were enrolled in the study but not proceed to randomization. These could include patients with undetermined histology as well as those who did not achieve response (PR or CR) after induction rituximab.
274860|NCT00075946|P4|Participant Flow|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
274861|NCT00075946|P3|Participant Flow|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
274862|NCT00075946|P2|Participant Flow|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
274863|NCT00075946|P1|Participant Flow|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
274864|NCT00075946|O2|Outcome|Arm B: Rituximab Scheduled|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
274865|NCT00075946|O1|Outcome|Arm A: Rituximab Retreatment|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
274866|NCT00075946|O4|Outcome|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
274867|NCT00075946|O3|Outcome|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
274868|NCT00075946|O2|Outcome|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
274869|NCT00075946|O1|Outcome|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
274870|NCT00075946|O4|Outcome|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
274871|NCT00075946|O3|Outcome|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
274872|NCT00075946|O2|Outcome|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
274873|NCT00075946|O1|Outcome|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
274874|NCT00075946|E3|Reported Event|Arm B: Rituximab Scheduled|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
274875|NCT00075946|E2|Reported Event|Arm A: Rituximab Retreatment|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
274876|NCT00075946|E1|Reported Event|Arm I: Induction Rituximab|Patients received rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms.
274877|NCT00076011|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
274878|NCT00076011|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
274879|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
274880|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
274881|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
274882|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
274883|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
274884|NCT00076011|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
274885|NCT00076024|B4|Baseline|Total|Total of all reporting groups
274886|NCT00076024|B3|Baseline|Docetaxel + Placebo (Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued with axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
274887|NCT00076024|B2|Baseline|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
274888|NCT00076024|B1|Baseline|Axitinib + Docetaxel (Phase 1, Lead-in)|Axitinib (AG-013736) 5 mg tablet orally twice daily BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.
274889|NCT00076024|P4|Participant Flow|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
274914|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
274890|NCT00076024|P3|Participant Flow|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
274891|NCT00076024|P2|Participant Flow|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
274892|NCT00076024|P1|Participant Flow|Axitinib + Docetaxel (Phase-1, Lead-in)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 milligram/square meter (mg/m^2) 1 hour (hr) intravenous (IV) infusion on Day 1 of each cycle, in cycles of 3 weeks.
274893|NCT00076024|O1|Outcome|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
274894|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
274895|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
274896|NCT00076024|O1|Outcome|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
274897|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
274898|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
274899|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
274900|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
274901|NCT00076024|E4|Reported Event|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
274902|NCT00076024|E3|Reported Event|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
274903|NCT00076024|E2|Reported Event|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
274904|NCT00076024|E1|Reported Event|Axitinib + Docetaxel (Phase-1 Lead-in)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.
274905|NCT00076050|B3|Baseline|Total|Total of all reporting groups
274906|NCT00076050|B2|Baseline|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
274907|NCT00076050|B1|Baseline|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
274908|NCT00076050|P2|Participant Flow|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
274909|NCT00076050|P1|Participant Flow|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
274910|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
274911|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
274912|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
274913|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
274915|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
274916|NCT00076050|E2|Reported Event|Placebo|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
274917|NCT00076050|E1|Reported Event|Soy Isoflavones|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
274918|NCT00076102|B1|Baseline|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
274919|NCT00076102|P1|Participant Flow|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
274920|NCT00076102|O1|Outcome|Pirfenidine|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
274921|NCT00076102|O1|Outcome|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
274922|NCT00076102|E1|Reported Event|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
274923|NCT00076219|B3|Baseline|Total|Total of all reporting groups
274924|NCT00076219|B2|Baseline|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
274925|NCT00076219|B1|Baseline|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
274926|NCT00076219|P2|Participant Flow|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
274927|NCT00076219|P1|Participant Flow|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
274928|NCT00076219|O2|Outcome|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
274929|NCT00076219|O1|Outcome|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
274930|NCT00076219|E2|Reported Event|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
274931|NCT00076219|E1|Reported Event|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
274932|NCT00076245|B5|Baseline|Total|Total of all reporting groups
274933|NCT00076245|B4|Baseline|4 Control|
274934|NCT00076245|B3|Baseline|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.
Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
274935|NCT00076245|B2|Baseline|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
274936|NCT00076245|B1|Baseline|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
274937|NCT00076245|P4|Participant Flow|4 Control|
274938|NCT00076245|P3|Participant Flow|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.
Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
274939|NCT00076245|P2|Participant Flow|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
274940|NCT00076245|P1|Participant Flow|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
274941|NCT00076245|O4|Outcome|4 Control|
274942|NCT00076245|O3|Outcome|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.
Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
274943|NCT00076245|O2|Outcome|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
274944|NCT00076245|O1|Outcome|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
274945|NCT00076245|O4|Outcome|4 Control|
274946|NCT00076245|O3|Outcome|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.
Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
274947|NCT00076245|O2|Outcome|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
274948|NCT00076245|O1|Outcome|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
274950|NCT00076245|E3|Reported Event|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.
Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
274951|NCT00076245|E2|Reported Event|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
274952|NCT00076245|E1|Reported Event|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
274953|NCT00076258|B3|Baseline|Total|Total of all reporting groups
274954|NCT00076258|B2|Baseline|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI
SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
274955|NCT00076258|B1|Baseline|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI
SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
274956|NCT00076258|P2|Participant Flow|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI
SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
274957|NCT00076258|P1|Participant Flow|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI
SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
274958|NCT00076258|O2|Outcome|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI
SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
274959|NCT00076258|O1|Outcome|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI
SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
274960|NCT00076258|E2|Reported Event|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI
SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
274961|NCT00076258|E1|Reported Event|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI
SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
274962|NCT00076336|B3|Baseline|Total|Total of all reporting groups
274963|NCT00076336|B2|Baseline|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274964|NCT00076336|B1|Baseline|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274965|NCT00076336|P2|Participant Flow|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274966|NCT00076336|P1|Participant Flow|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274967|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274968|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274969|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274970|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274971|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274972|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274973|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274974|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274975|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274976|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274977|NCT00076336|E2|Reported Event|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274978|NCT00076336|E1|Reported Event|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
274979|NCT00076570|B3|Baseline|Total|Total of all reporting groups
274980|NCT00076570|B2|Baseline|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
274981|NCT00076570|B1|Baseline|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
274982|NCT00076570|P2|Participant Flow|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
274983|NCT00076570|P1|Participant Flow|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
274984|NCT00076570|O2|Outcome|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
274985|NCT00076570|O1|Outcome|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
274986|NCT00076570|O2|Outcome|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
274987|NCT00076570|O1|Outcome|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
274988|NCT00076570|E2|Reported Event|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
274989|NCT00076570|E1|Reported Event|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
274990|NCT00076687|B4|Baseline|Total|Total of all reporting groups
274991|NCT00076687|B3|Baseline|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
274992|NCT00076687|B2|Baseline|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
274993|NCT00076687|B1|Baseline|Placebo|Placebo
274994|NCT00076687|P3|Participant Flow|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
274995|NCT00076687|P2|Participant Flow|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
274996|NCT00076687|P1|Participant Flow|Placebo|Placebo
274997|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
274998|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
274999|NCT00076687|O1|Outcome|Placebo|Placebo
275000|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
275001|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
275002|NCT00076687|O1|Outcome|Placebo|Placebo
275003|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
275004|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
275005|NCT00076687|O1|Outcome|Placebo|Placebo
275006|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
275007|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
275008|NCT00076687|O1|Outcome|Placebo|Placebo
275009|NCT00076687|E3|Reported Event|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
275010|NCT00076687|E2|Reported Event|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
275011|NCT00076687|E1|Reported Event|Placebo|Placebo
275063|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275064|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275012|NCT00076752|B1|Baseline|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275013|NCT00076752|P1|Participant Flow|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
275014|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275015|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275016|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275017|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275018|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275019|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275020|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275021|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275022|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275023|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275024|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275025|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275026|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275027|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275028|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
275029|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
275030|NCT00076752|E1|Reported Event|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).
SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
275031|NCT00076804|B3|Baseline|Total|Total of all reporting groups
275032|NCT00076804|B2|Baseline|Self Administration|Self administration of ARVs
275033|NCT00076804|B1|Baseline|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
275034|NCT00076804|P2|Participant Flow|Self Administration|Self administration of ARVs
275035|NCT00076804|P1|Participant Flow|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
275036|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
275037|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
275038|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
275039|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
275040|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
275041|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
275042|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
275043|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
275044|NCT00076804|E2|Reported Event|Self Administration|Self administration of ARVs
275045|NCT00076804|E1|Reported Event|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
275046|NCT00076999|B5|Baseline|Total|Total of all reporting groups
275047|NCT00076999|B4|Baseline|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275048|NCT00076999|B3|Baseline|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275049|NCT00076999|B2|Baseline|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275050|NCT00076999|B1|Baseline|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275051|NCT00076999|P5|Participant Flow|TPV SEDDS 12-18 Yrs|TPV self-emulsifying drug delivery system (SEDDS), ages 12-18
275052|NCT00076999|P4|Participant Flow|TPV SEDDS 6-<12 Yrs|TPV self-emulsifying drug delivery system (SEDDS), ages 6-11
275053|NCT00076999|P3|Participant Flow|TPV OS 12-18 Yrs|Tipranavir Oral Solution (TPV OS), ages 12-18
275054|NCT00076999|P2|Participant Flow|TPV OS 6-<12 Yrs|Tipranavir Oral Solution (TPV OS), ages 6-11
275055|NCT00076999|P1|Participant Flow|TPV OS 2-<6 Yrs|Tipranavir Oral Solution (TPV OS), ages 2-5
275056|NCT00076999|O5|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275057|NCT00076999|O4|Outcome|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
275058|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275059|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275060|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275061|NCT00076999|O5|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275062|NCT00076999|O4|Outcome|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
275065|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275066|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275067|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275068|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275069|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275070|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275071|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275072|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275073|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275074|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275075|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275076|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275077|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275078|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275079|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275080|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275081|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275082|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275083|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275084|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275085|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275086|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275087|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275088|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275089|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275090|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275091|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275092|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275093|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275094|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275095|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275096|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275097|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275098|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275099|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275100|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275101|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275102|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275103|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275104|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275105|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275106|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275107|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275108|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275109|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275110|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275111|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275112|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275113|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275114|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275115|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275116|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275117|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275118|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275119|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275120|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275121|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275122|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275123|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275124|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275125|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
328403|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
275126|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275127|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275128|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275129|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275130|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275131|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275132|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275133|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275134|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275135|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275136|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275137|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275138|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275139|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275140|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275141|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275142|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275143|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275144|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275145|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275146|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275147|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275148|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275149|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275150|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275151|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275152|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275153|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275154|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275155|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275156|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275157|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275158|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275159|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275160|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275161|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275162|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275163|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275164|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275165|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275166|NCT00076999|E5|Reported Event|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
275167|NCT00076999|E4|Reported Event|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
275168|NCT00076999|E3|Reported Event|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
275169|NCT00076999|E2|Reported Event|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
275170|NCT00076999|E1|Reported Event|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
275171|NCT00077207|B1|Baseline|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.
carboplatin: Given IV
temozolomide: Given orally
vincristine sulfate: Given IV"
275172|NCT00077207|P1|Participant Flow|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.
carboplatin: Given IV
temozolomide: Given orally
vincristine sulfate: Given IV"
275195|NCT00070564|P3|Participant Flow|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275173|NCT00077207|O1|Outcome|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.
carboplatin: Given IV
temozolomide: Given orally
vincristine sulfate: Given IV"
275174|NCT00077207|O1|Outcome|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.
carboplatin: Given IV
temozolomide: Given orally
vincristine sulfate: Given IV"
275175|NCT00077207|E1|Reported Event|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.
carboplatin: Given IV
temozolomide: Given orally
vincristine sulfate: Given IV"
275176|NCT00077376|B1|Baseline|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.
After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
275177|NCT00077376|P1|Participant Flow|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.
After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
275178|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.
After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
275179|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.
After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
275180|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.
After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
275181|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.
After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
275279|NCT00071110|B1|Baseline|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
275182|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.
After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
275183|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.
After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
275184|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.
After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
275185|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.
After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
275186|NCT00077376|E1|Reported Event|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.
After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
275187|NCT00070564|B5|Baseline|Total|Total of all reporting groups
275188|NCT00070564|B4|Baseline|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275189|NCT00070564|B3|Baseline|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275190|NCT00070564|B2|Baseline|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275191|NCT00070564|B1|Baseline|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275192|NCT00070564|P6|Participant Flow|Arm VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
275193|NCT00070564|P5|Participant Flow|Arm V|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
275194|NCT00070564|P4|Participant Flow|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275196|NCT00070564|P2|Participant Flow|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275197|NCT00070564|P1|Participant Flow|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275198|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275199|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275200|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275201|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275202|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275203|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275204|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275205|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275206|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275207|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275208|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275209|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275210|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275211|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275280|NCT00071110|P2|Participant Flow|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
275212|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275213|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275214|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275215|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275216|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275217|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275218|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275219|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275220|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275221|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275222|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275223|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275224|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275225|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275226|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275227|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275281|NCT00071110|P1|Participant Flow|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
275228|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275229|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275230|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275231|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275232|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275233|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275234|NCT00070564|E4|Reported Event|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275235|NCT00070564|E3|Reported Event|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275236|NCT00070564|E2|Reported Event|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275237|NCT00070564|E1|Reported Event|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV"
275238|NCT00070941|B4|Baseline|Total|Total of all reporting groups
275239|NCT00070941|B3|Baseline|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
275240|NCT00070941|B2|Baseline|Escitalopram|oral Escitalopram 10mg or 20m
275241|NCT00070941|B1|Baseline|SAM-e|oral SAM-e, 1200mg or 2400 mg
275242|NCT00070941|P3|Participant Flow|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
275243|NCT00070941|P2|Participant Flow|Escitalopram|oral Escitalopram 10mg or 20m
275244|NCT00070941|P1|Participant Flow|SAM-e|SAM-e, 1200mg or 2400 mg
275245|NCT00070941|O3|Outcome|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
275246|NCT00070941|O2|Outcome|Escitalopram|oral Escitalopram 10mg or 20m
275247|NCT00070941|O1|Outcome|SAM-e|SAM-e, 1200mg or 2400 mg
275248|NCT00070941|E3|Reported Event|Placebo|Group C/Twenty patients receiving oral placebo Escitalopram an
275249|NCT00070941|E2|Reported Event|Oral Escitalopram|Group B/Forty patients receiving oral Escitalopram 10mg or 20m
275250|NCT00070941|E1|Reported Event|SAM-e|Group A/Forty patients receiving oral SAM-e, 1200mg or 2400 mg
275251|NCT00071006|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
275252|NCT00071006|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
275253|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
275254|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
275255|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
275256|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
275257|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
275258|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
275259|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
275260|NCT00071006|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
275261|NCT00071032|B3|Baseline|Total|Total of all reporting groups
275262|NCT00071032|B2|Baseline|Restrictive Strategy|"Symptomatic transfusion strategy, a more conservative strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia.
Restrictive (Symptomatic) Transfusion Strategy: Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL."
275263|NCT00071032|B1|Baseline|Liberal (10 g/dL) Transfusion Strategy|"Transfusion strategy that maintains postoperative Hgb levels above 10 g/dL.
Liberal (10 g/dL) Transfusion Strategy: Maintains postoperative Hgb levels above 10 g/dL. This threshold strategy uses enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization."
275264|NCT00071032|P2|Participant Flow|Restrictive Strategy|Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
275265|NCT00071032|P1|Participant Flow|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
275266|NCT00071032|O2|Outcome|Restrictive Strategy|Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
275267|NCT00071032|O1|Outcome|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
275268|NCT00071032|O2|Outcome|Restrictive Strategy|Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
275269|NCT00071032|O1|Outcome|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
275270|NCT00071032|E2|Reported Event|Restrictive Strategy|Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
275271|NCT00071032|E1|Reported Event|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains post randomization Hgb levels >= 10 g/dL
275272|NCT00071058|B1|Baseline|Surgery Plus Chemothrapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.
Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
275273|NCT00071058|P1|Participant Flow|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.
Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
275274|NCT00071058|O1|Outcome|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.
Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
275275|NCT00071058|O1|Outcome|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.
Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
275276|NCT00071058|E1|Reported Event|Surgery Plus Chemothrapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.
Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
275277|NCT00071110|B3|Baseline|Total|Total of all reporting groups
275278|NCT00071110|B2|Baseline|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
275282|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
275283|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
275284|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
275285|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
275286|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
275287|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
275288|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
275289|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
275290|NCT00071110|E2|Reported Event|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
275291|NCT00071110|E1|Reported Event|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
275292|NCT00071396|B1|Baseline|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.
Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
275293|NCT00071396|P1|Participant Flow|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.
Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
275294|NCT00071396|O1|Outcome|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.
Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
275295|NCT00071396|E1|Reported Event|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.
Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
275296|NCT00077610|B4|Baseline|Total|Total of all reporting groups
275297|NCT00077610|B3|Baseline|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
275298|NCT00077610|B2|Baseline|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275299|NCT00077610|B1|Baseline|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275300|NCT00077610|P3|Participant Flow|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
275301|NCT00077610|P2|Participant Flow|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275302|NCT00077610|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram [mcg]) that was based on the Epoetin dose (<8000, 8000-16000, >16000 International units [IU]/Week) administered during the week preceding the switch to the study drug.
275303|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
275304|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose administered during the week preceding the switch to the study drug.
275305|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275306|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
275307|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275308|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275309|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
328404|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
275310|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275311|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275312|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
275313|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275314|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275315|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
275316|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275317|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275318|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks
275319|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275320|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275321|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
275322|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275323|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275324|NCT00077610|O3|Outcome|Epoetin (1-3x/Week)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
275325|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275326|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 120,180 mcg) that was based on the Epoetin dose administered (<8000, 8000-16000, >16000 IU/Week) during the week preceding the switch to the study drug.
275327|NCT00077610|E3|Reported Event|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
275328|NCT00077610|E2|Reported Event|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275329|NCT00077610|E1|Reported Event|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
275330|NCT00077623|B4|Baseline|Total|Total of all reporting groups
275331|NCT00077623|B3|Baseline|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
275332|NCT00077623|B2|Baseline|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the Epoetin dose of<8000, 8000-16000, or >16000 IU/Week administered during the week preceding the switch to the study drug.
275333|NCT00077623|B1|Baseline|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the Epoetin dose of<8000, 8000-16000,or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
275334|NCT00077623|P3|Participant Flow|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
328405|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
275335|NCT00077623|P2|Participant Flow|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
275336|NCT00077623|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units per week (IU/week), administered during the week preceding the switch to the study drug.
275337|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
275338|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
275339|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
275340|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
275341|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
275342|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
275343|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
275344|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
275345|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
275346|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
275347|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
275348|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
275349|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
275350|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
275351|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
275352|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
275353|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
275354|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
275355|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
275356|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
275357|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
275476|NCT00078286|O2|Outcome|Placebo|Participants will take placebo for 12 weeks
275358|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
275359|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
275360|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
275361|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
275362|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
275363|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
275364|NCT00077623|E3|Reported Event|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
275365|NCT00077623|E2|Reported Event|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
275366|NCT00077623|E1|Reported Event|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
275367|NCT00077636|B3|Baseline|Total|Total of all reporting groups
275368|NCT00077636|B2|Baseline|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
275369|NCT00077636|B1|Baseline|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
275370|NCT00077636|P2|Participant Flow|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants received 180 mcg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
275371|NCT00077636|P1|Participant Flow|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants received 180 micrograms (mcg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
275372|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
275373|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 16 weeks.
275374|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
275375|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
275376|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
275377|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
275378|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
275379|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
275380|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
275381|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
275382|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
275383|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
275384|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
275385|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
275386|NCT00077636|E2|Reported Event|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
275387|NCT00077636|E1|Reported Event|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
275388|NCT00077649|B5|Baseline|Total|Total of all reporting groups
275477|NCT00078286|O1|Outcome|Sertraline|Participants will take sertraline for 12 weeks
275389|NCT00077649|B4|Baseline|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275390|NCT00077649|B3|Baseline|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks.
275391|NCT00077649|B2|Baseline|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275392|NCT00077649|B1|Baseline|PEG-IFN Alfa-2a 180 mcg+ Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks.
275393|NCT00077649|P4|Participant Flow|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275394|NCT00077649|P3|Participant Flow|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275395|NCT00077649|P2|Participant Flow|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275396|NCT00077649|P1|Participant Flow|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 micrograms (mcg) of PEG-IFN [peginterferon] alfa-2a in 1 milliliter (mL) solution administered subcutaneously (SC), once weekly + 1200 milligrams (mg) of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
275397|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275398|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275399|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275400|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275401|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275402|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275403|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275404|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275405|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg+ Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275406|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275407|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275408|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275409|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275410|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275411|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275412|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275413|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275414|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275415|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275416|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275417|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275418|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275419|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275420|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275421|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275422|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275423|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275424|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275425|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275426|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275427|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275428|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275429|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
275430|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275431|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275432|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275433|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275434|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275435|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275436|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275437|NCT00077649|E4|Reported Event|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275438|NCT00077649|E3|Reported Event|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
275439|NCT00077649|E2|Reported Event|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
275440|NCT00077649|E1|Reported Event|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered [subcutaneously] sc, once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
275441|NCT00077675|B3|Baseline|Total|Total of all reporting groups
275442|NCT00077675|B2|Baseline|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
275443|NCT00077675|B1|Baseline|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
275444|NCT00077675|P2|Participant Flow|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
275445|NCT00077675|P1|Participant Flow|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
275446|NCT00077675|O2|Outcome|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
275447|NCT00077675|O1|Outcome|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
275448|NCT00077675|E2|Reported Event|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
275449|NCT00077675|E1|Reported Event|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
275450|NCT00077766|B3|Baseline|Total|Total of all reporting groups
275451|NCT00077766|B2|Baseline|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
275452|NCT00077766|B1|Baseline|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
275453|NCT00077766|P2|Participant Flow|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
275454|NCT00077766|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV), every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 microgram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
275455|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
275456|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
275457|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
275458|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
275459|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
275460|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
275461|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
275462|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
275463|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
275464|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
275465|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
275466|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
275467|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
275468|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
275469|NCT00077766|E2|Reported Event|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
275470|NCT00077766|E1|Reported Event|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
275471|NCT00078286|B3|Baseline|Total|Total of all reporting groups
275472|NCT00078286|B2|Baseline|Placebo|Participants will take placebo for 12 weeks
275473|NCT00078286|B1|Baseline|Sertraline|Participants will take sertraline for 12 weeks
275474|NCT00078286|P2|Participant Flow|Placebo|Participants will take placebo for 12 weeks
275475|NCT00078286|P1|Participant Flow|Sertraline|Participants will take sertraline for 12 weeks
275478|NCT00078286|O2|Outcome|Placebo|Participants will take placebo for 12 weeks
275479|NCT00078286|O1|Outcome|Sertraline|Participants will take sertraline for 12 weeks
275480|NCT00078286|E2|Reported Event|Placebo|Serious adverse events in Placebo Arm
275481|NCT00078286|E1|Reported Event|Sertraline|Serious adverse events in Sertraline Arm
275482|NCT00078312|B1|Baseline|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
275483|NCT00078312|P1|Participant Flow|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
275484|NCT00078312|O1|Outcome|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
275485|NCT00078312|E1|Reported Event|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
275486|NCT00078325|B4|Baseline|Total|Total of all reporting groups
275487|NCT00078325|B3|Baseline|Placebo|Matching placebo tablets once daily
275488|NCT00078325|B2|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275489|NCT00078325|B1|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
275490|NCT00078325|P3|Participant Flow|Placebo|Matching placebo tablets once daily
275491|NCT00078325|P2|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275492|NCT00078325|P1|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
275493|NCT00078325|O3|Outcome|Placebo|Matching placebo tablets once daily
275494|NCT00078325|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275495|NCT00078325|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
275496|NCT00078325|O3|Outcome|Placebo|Matching placebo tablets once daily
275497|NCT00078325|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275498|NCT00078325|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
275499|NCT00078325|E3|Reported Event|Placebo|Matching placebo tablets once daily
275500|NCT00078325|E2|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275501|NCT00078325|E1|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
275502|NCT00078377|B4|Baseline|Total|Total of all reporting groups
275503|NCT00078377|B3|Baseline|Placebo|Matching placebo tablets once daily in the morning
275504|NCT00078377|B2|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275505|NCT00078377|B1|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
275506|NCT00078377|P3|Participant Flow|Placebo|Matching placebo tablets once daily in the morning
275507|NCT00078377|P2|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275508|NCT00078377|P1|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
275509|NCT00078377|O4|Outcome|Armodafinil Combined Group (250 mg/Day and 150 mg/Day)|
275510|NCT00078377|O3|Outcome|Placebo|Matching placebo tablets once daily in the morning
275511|NCT00078377|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275512|NCT00078377|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
275513|NCT00078377|O4|Outcome|Armodafinil Combined Group (250 mg/Day and 150 mg/Day)|
275514|NCT00078377|O3|Outcome|Placebo|Matching placebo tablets once daily in the morning
275515|NCT00078377|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275516|NCT00078377|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
275517|NCT00078377|E3|Reported Event|Placebo|Matching placebo tablets once daily in the morning
275518|NCT00078377|E2|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275519|NCT00078377|E1|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
275520|NCT00078403|B4|Baseline|Total|Total of all reporting groups
275521|NCT00078403|B3|Baseline|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275522|NCT00078403|B2|Baseline|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275523|NCT00078403|B1|Baseline|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275524|NCT00078403|P3|Participant Flow|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
276229|NCT00083174|E1|Reported Event|Exemestane|one 25 mg tablet daily in am
275525|NCT00078403|P2|Participant Flow|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275526|NCT00078403|P1|Participant Flow|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275527|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275528|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275529|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275530|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275531|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275532|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275533|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation..
275534|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275535|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275536|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275537|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275538|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275539|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275540|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275541|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
276985|NCT00086450|E2|Reported Event|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
275542|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275543|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275544|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275545|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275546|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275547|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275548|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275549|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275550|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275551|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275552|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275553|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275554|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275555|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275556|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275557|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275558|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
276399|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
275559|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275560|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275561|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275562|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275563|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275564|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275565|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275566|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275567|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275568|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275569|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275570|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275571|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275572|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275573|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275574|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275575|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
276400|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
275576|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
275577|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
275578|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
275579|NCT00078403|E3|Reported Event|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & ribavirin [RBV] 1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.
275580|NCT00078403|E2|Reported Event|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
275581|NCT00078403|E1|Reported Event|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
275582|NCT00078559|B1|Baseline|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275583|NCT00078559|P1|Participant Flow|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275584|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
275585|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275586|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
275587|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275588|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
275589|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275590|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
275591|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275592|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
275593|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275594|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
275595|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275596|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
275597|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275598|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
275599|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275600|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
275601|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275631|NCT00078754|O3|Outcome|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks
Placebo: Placebo capsules by mouth, up to 8 capsules daily"
275632|NCT00078754|O2|Outcome|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks
Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
275602|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275603|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275604|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275605|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275606|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275607|NCT00078559|E1|Reported Event|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
275608|NCT00078715|B1|Baseline|Overall Study|
275609|NCT00078715|P2|Participant Flow|Yohimbine Then Placebo|Participants are randomized to blindly receive yohimbine for 8 days then placebo for the same.
275610|NCT00078715|P1|Participant Flow|Placebo Then Yohimbine|Participants are randomized to blindly receive placebo for 8 days then yohimbine for the same.
275611|NCT00078715|O2|Outcome|Yohimbine|Participants are randomized to blindly receive yohimbine for 8 days.
275612|NCT00078715|O1|Outcome|Placebo|Participants are randomized to blindly receive placebo for 8 days.
275613|NCT00078715|E2|Reported Event|Yohimbine|
275614|NCT00078715|E1|Reported Event|Placebo|
275615|NCT00078728|B3|Baseline|Total|Total of all reporting groups
275616|NCT00078728|B2|Baseline|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
275617|NCT00078728|B1|Baseline|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
275618|NCT00078728|P2|Participant Flow|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
275619|NCT00078728|P1|Participant Flow|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
275620|NCT00078728|O2|Outcome|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
275621|NCT00078728|O1|Outcome|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
275622|NCT00078728|E2|Reported Event|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
275623|NCT00078728|E1|Reported Event|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
275624|NCT00078754|B4|Baseline|Total|Total of all reporting groups
275625|NCT00078754|B3|Baseline|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks
Placebo: Placebo capsules by mouth, up to 8 capsules daily"
275626|NCT00078754|B2|Baseline|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks
Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
275627|NCT00078754|B1|Baseline|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks
Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
275628|NCT00078754|P3|Participant Flow|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks
Placebo: Placebo capsules by mouth, up to 8 capsules daily"
275629|NCT00078754|P2|Participant Flow|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks
Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
275630|NCT00078754|P1|Participant Flow|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks
Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
328406|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
275633|NCT00078754|O1|Outcome|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks
Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
275634|NCT00078754|E3|Reported Event|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks
Placebo: Placebo capsules by mouth, up to 8 capsules daily"
275635|NCT00078754|E2|Reported Event|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks
Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
275636|NCT00078754|E1|Reported Event|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks
Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
275637|NCT00078767|B3|Baseline|Total|Total of all reporting groups
275638|NCT00078767|B2|Baseline|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
275639|NCT00078767|B1|Baseline|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day
Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
275640|NCT00078767|P2|Participant Flow|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
275641|NCT00078767|P1|Participant Flow|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day
Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
275642|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
275643|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day
Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
275644|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
275645|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day
Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
275646|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
275647|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day
Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
275671|NCT00078949|E2|Reported Event|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.
cisplatin: Given IV
cytarabine: Given IV
dexamethasone: Given IV"
275724|NCT00079274|O2|Outcome|Wild-type KRAS Arm D|Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm A patients.
275648|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
275649|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day
Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
275650|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
275651|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day
Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
275652|NCT00078767|E2|Reported Event|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
275653|NCT00078767|E1|Reported Event|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day
Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
275654|NCT00078949|B5|Baseline|Total|Total of all reporting groups
275655|NCT00078949|B4|Baseline|Observation|Patients undergo observation only.
275656|NCT00078949|B3|Baseline|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV"
275657|NCT00078949|B2|Baseline|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.
cisplatin: Given IV
cytarabine: Given IV
dexamethasone: Given IV"
275658|NCT00078949|B1|Baseline|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.
cisplatin: Given IV
dexamethasone: Given IV
gemcitabine hydrochloride: Given IV"
275659|NCT00078949|P4|Participant Flow|Observation|Patients undergo observation only.
275660|NCT00078949|P3|Participant Flow|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV"
275661|NCT00078949|P2|Participant Flow|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.
cisplatin: Given IV
cytarabine: Given IV
dexamethasone: Given IV"
275662|NCT00078949|P1|Participant Flow|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.
cisplatin: Given IV
dexamethasone: Given IV
gemcitabine hydrochloride: Given IV"
275663|NCT00078949|O2|Outcome|Observation|Patients undergo observation only.
275664|NCT00078949|O1|Outcome|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV"
275665|NCT00078949|O2|Outcome|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.
cisplatin: Given IV
cytarabine: Given IV
dexamethasone: Given IV"
275666|NCT00078949|O1|Outcome|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.
cisplatin: Given IV
dexamethasone: Given IV
gemcitabine hydrochloride: Given IV"
275667|NCT00078949|O2|Outcome|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.
cisplatin: Given IV
cytarabine: Given IV
dexamethasone: Given IV"
275668|NCT00078949|O1|Outcome|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.
cisplatin: Given IV
dexamethasone: Given IV
gemcitabine hydrochloride: Given IV"
275669|NCT00078949|E4|Reported Event|Observation|Patients undergo observation only.
275670|NCT00078949|E3|Reported Event|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV"
275672|NCT00078949|E1|Reported Event|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.
cisplatin: Given IV
dexamethasone: Given IV
gemcitabine hydrochloride: Given IV"
275673|NCT00079001|B3|Baseline|Total|Total of all reporting groups
275674|NCT00079001|B2|Baseline|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
275675|NCT00079001|B1|Baseline|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
275676|NCT00079001|P2|Participant Flow|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
275677|NCT00079001|P1|Participant Flow|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
275678|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
275679|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
275680|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
275681|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
275682|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
275683|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
275684|NCT00079001|E2|Reported Event|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
275685|NCT00079001|E1|Reported Event|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
275686|NCT00079040|B1|Baseline|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
275687|NCT00079040|P1|Participant Flow|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
275688|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
275689|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
275690|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
275691|NCT00079040|E1|Reported Event|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
275692|NCT00079183|B1|Baseline|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275693|NCT00079183|P1|Participant Flow|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275694|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275695|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275696|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275697|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275698|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275699|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275700|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275701|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275702|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275703|NCT00079183|O1|Outcome|Sirolimus|"Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
sirolimus: Given PO
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies"
275704|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275722|NCT00079274|O2|Outcome|Mutant KRAS Arm D|Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are mutant KRAS and concurrently randomized with Arm A patients.
275723|NCT00079274|O1|Outcome|Mutant KRAS Arm A|Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are mutant KRAS and concurrently randomized with Arm D patients.
276986|NCT00086450|E1|Reported Event|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
275705|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275706|NCT00079183|E1|Reported Event|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
275707|NCT00079274|B8|Baseline|Total|Total of all reporting groups
275708|NCT00079274|B7|Baseline|Arm G (Locally Directed Therapy)|"Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.
Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists."
275709|NCT00079274|B6|Baseline|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and chemotherapy as in arm C.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV"
275710|NCT00079274|B5|Baseline|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV"
275711|NCT00079274|B4|Baseline|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV"
275712|NCT00079274|B3|Baseline|Arm C (Combination Chemotherapy)|"Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
275713|NCT00079274|B2|Baseline|Arm B (Combination Chemotherapy)|"Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
275714|NCT00079274|B1|Baseline|Arm A (Combination Chemotherapy)|"Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
275715|NCT00079274|P7|Participant Flow|Arm G (Locally Directed Therapy)|"Patients determined to have mutated Kirsten rat sarcoma (KRAS) (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.
Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists."
275716|NCT00079274|P6|Participant Flow|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and chemotherapy as in arm C.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV"
275717|NCT00079274|P5|Participant Flow|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given I
cetuximab: Given IV"
275718|NCT00079274|P4|Participant Flow|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV"
275719|NCT00079274|P3|Participant Flow|Arm C (Combination Chemotherapy)|"Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
275720|NCT00079274|P2|Participant Flow|Arm B (Combination Chemotherapy)|"Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
275721|NCT00079274|P1|Participant Flow|Arm A (Combination Chemotherapy)|"Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
275725|NCT00079274|O1|Outcome|Wild-type KRAS Arm A|Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm D patients.
275726|NCT00079274|E7|Reported Event|Arm G (Locally Directed Therapy)|"Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.
Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists."
275727|NCT00079274|E6|Reported Event|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab as in arm D and chemotherapy as in arm C.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV"
275728|NCT00079274|E5|Reported Event|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV"
275729|NCT00079274|E4|Reported Event|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV"
275730|NCT00079274|E3|Reported Event|Arm C (Combination Chemotherapy)|"Patients receive the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
275731|NCT00079274|E2|Reported Event|Arm B (Combination Chemotherapy)|"Patients receive irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
275732|NCT00079274|E1|Reported Event|Arm A (Combination Chemotherapy)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
275733|NCT00079326|B3|Baseline|Total|Total of all reporting groups
275734|NCT00079326|B2|Baseline|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
275735|NCT00079326|B1|Baseline|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
275736|NCT00079326|P2|Participant Flow|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
275737|NCT00079326|P1|Participant Flow|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
275738|NCT00079326|O2|Outcome|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
275739|NCT00079326|O1|Outcome|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
275740|NCT00079326|O2|Outcome|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
275741|NCT00079326|O1|Outcome|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
275742|NCT00079326|E1|Reported Event|All Study Participants|All Adverse Events and Serious Adverse event data was pooled because all participants received the same treatment.
275743|NCT00079339|B4|Baseline|Total|Total of all reporting groups
275744|NCT00079339|B3|Baseline|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only."
275745|NCT00079339|B2|Baseline|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
275746|NCT00079339|B1|Baseline|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only."
275747|NCT00079339|P3|Participant Flow|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only."
275748|NCT00079339|P2|Participant Flow|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
275749|NCT00079339|P1|Participant Flow|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only."
275750|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had a baseline positron emission tomography (PET) scan.
275751|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had a baseline positron emission tomography (PET) scan.
275752|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI scan.
275753|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI diffusion scan.
275754|NCT00079339|O1|Outcome|Tipifarnib - Any Dose Level|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI perfusion scan.
275755|NCT00079339|O1|Outcome|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
275756|NCT00079339|O3|Outcome|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study."
275757|NCT00079339|O2|Outcome|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
275758|NCT00079339|O1|Outcome|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study."
275855|NCT00080119|E1|Reported Event|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
275759|NCT00079339|E3|Reported Event|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only."
275760|NCT00079339|E2|Reported Event|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
275761|NCT00079339|E1|Reported Event|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only."
275762|NCT00079391|B1|Baseline|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
275763|NCT00079391|P1|Participant Flow|"Bone Marrow Transplantation Using Nexell Isolex 300i"|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. cluster of differentiation 34 (CD34) selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
275764|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
275765|NCT00079391|O1|Outcome|"Bone Marrow Transplantation Using Nexell Isolex 300i"|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
275766|NCT00079391|O1|Outcome|"Bone Marrow Transplantation Using Nexell Isolex 300i"|"Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. Cluster of differentiation 34 (CD34) selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant."
275767|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
275768|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
275769|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
275770|NCT00079391|E1|Reported Event|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
275771|NCT00079417|B1|Baseline|Vincristine Sulfate and Carboplatin and Surgery|Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
275884|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
275885|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
275772|NCT00079417|P1|Participant Flow|Vincristine Sulfate and Carboplatin and Surgery|"Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.
infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects
iodine I 125: Undergo radioactive therapy
ruthenium Ru 106: Undergo radioactive therapy
carboplatin: Given IV
vincristine sulfate: Given IV"
275773|NCT00079417|O1|Outcome|Vincristine Sulfate and Carboplatin and Surgery|"Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.
infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects
iodine I 125: Undergo radioactive therapy
ruthenium Ru 106: Undergo radioactive therapy
carboplatin: Given IV
vincristine sulfate: Given IV"
275774|NCT00079417|E1|Reported Event|Vincristine Sulfate and Carboplatin and Surgery|Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
275775|NCT00079677|B3|Baseline|Total|Total of all reporting groups
275776|NCT00079677|B2|Baseline|Placebo|Matching placebo tablets once daily
275777|NCT00079677|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275778|NCT00079677|P2|Participant Flow|Placebo|Matching placebo tablets once daily
275779|NCT00079677|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275780|NCT00079677|O2|Outcome|Placebo|Matching placebo tablets once daily
275781|NCT00079677|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275782|NCT00079677|O2|Outcome|Placebo|Matching placebo tablets once daily
275783|NCT00079677|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275784|NCT00079677|E2|Reported Event|Placebo|Matching placebo tablets once daily
275785|NCT00079677|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
275786|NCT00079781|B4|Baseline|Total|Total of all reporting groups
275787|NCT00079781|B3|Baseline|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
275788|NCT00079781|B2|Baseline|Treatment Group|Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
275789|NCT00079781|B1|Baseline|Open Label Group|Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
275790|NCT00079781|P3|Participant Flow|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
275791|NCT00079781|P2|Participant Flow|Treatment Group|Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
275792|NCT00079781|P1|Participant Flow|Open Label Group|Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
275793|NCT00079781|O1|Outcome|Treatment Population|Open Label Group and Treatment Group combined.
275794|NCT00079781|O1|Outcome|All Participants|Open Label Group, Treatment Group, and Sham Group combined.
275795|NCT00079781|O1|Outcome|All Participants|Open Label Group, Treatment Group, and Sham Group combined.
275796|NCT00079781|E2|Reported Event|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period). Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
275797|NCT00079781|E1|Reported Event|Treatment Population|Open Label Group and Treatment Group combined.
275798|NCT00079937|B3|Baseline|Total|Total of all reporting groups
275886|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
276401|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
275799|NCT00079937|B2|Baseline|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275800|NCT00079937|B1|Baseline|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275801|NCT00079937|P2|Participant Flow|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275802|NCT00079937|P1|Participant Flow|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275803|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275804|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275805|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275806|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275807|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275808|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275809|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275810|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275811|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275812|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
276039|NCT00081861|O1|Outcome|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
275813|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275814|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275815|NCT00079937|E2|Reported Event|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275816|NCT00079937|E1|Reported Event|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
275817|NCT00080119|B5|Baseline|Total|Total of all reporting groups
275818|NCT00080119|B4|Baseline|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
275819|NCT00080119|B3|Baseline|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
275820|NCT00080119|B2|Baseline|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
275821|NCT00080119|B1|Baseline|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
275822|NCT00080119|P4|Participant Flow|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
275823|NCT00080119|P3|Participant Flow|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
275824|NCT00080119|P2|Participant Flow|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
275825|NCT00080119|P1|Participant Flow|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
275826|NCT00080119|O4|Outcome|HIVpos/PL|
275827|NCT00080119|O3|Outcome|HIVpos/INH|
275828|NCT00080119|O2|Outcome|HIVneg/PL|
275829|NCT00080119|O1|Outcome|HIVneg/INH|
275830|NCT00080119|O4|Outcome|HIVpos/PL|
275831|NCT00080119|O3|Outcome|HIVpos/INH|
275832|NCT00080119|O2|Outcome|HIVneg/PL|
275833|NCT00080119|O1|Outcome|HIVneg/INH|
275834|NCT00080119|O4|Outcome|HIVpos/PL|
275835|NCT00080119|O3|Outcome|HIVpos/INH|
275836|NCT00080119|O2|Outcome|HIVneg/PL|
275837|NCT00080119|O1|Outcome|HIVneg/INH|
275838|NCT00080119|O4|Outcome|HIVpos/PL|
275839|NCT00080119|O3|Outcome|HIVpos/INH|
275840|NCT00080119|O2|Outcome|HIVneg/PL|
275841|NCT00080119|O1|Outcome|HIVneg/INH|
275842|NCT00080119|O2|Outcome|HIVneg/PL|
275843|NCT00080119|O1|Outcome|HIVneg/INH|
275844|NCT00080119|O2|Outcome|HIVpos/PL|
275845|NCT00080119|O1|Outcome|HIVpos/INH|
275846|NCT00080119|O2|Outcome|HIVpos/PL|
275847|NCT00080119|O1|Outcome|HIVpos/INH|
275848|NCT00080119|O2|Outcome|HIVneg/PL|
275849|NCT00080119|O1|Outcome|HIVneg/INH|
275850|NCT00080119|O2|Outcome|HIVpos/PL|
275851|NCT00080119|O1|Outcome|HIVpos/INH|
275852|NCT00080119|E4|Reported Event|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
275853|NCT00080119|E3|Reported Event|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
275854|NCT00080119|E2|Reported Event|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
276082|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|Bradykinesia measured in the hands and arms while off medication and receiving sham tDCS.
275856|NCT00080223|B1|Baseline|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
275857|NCT00080223|P1|Participant Flow|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 milligram per day (mg/d). At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose greater than (>) 4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
275858|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
275859|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
275860|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
275861|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
275862|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
275863|NCT00080223|E1|Reported Event|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
275864|NCT00080288|B3|Baseline|Total|Total of all reporting groups
275865|NCT00080288|B2|Baseline|Placebo|Matching placebo tablets once daily
275866|NCT00080288|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
275867|NCT00080288|P2|Participant Flow|Placebo|Matching placebo tablets once daily
275868|NCT00080288|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
275869|NCT00080288|O2|Outcome|Placebo|Matching placebo tablets once daily
275870|NCT00080288|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
275871|NCT00080288|O2|Outcome|Placebo|Matching placebo tablets once daily
275872|NCT00080288|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
275873|NCT00080288|E2|Reported Event|Placebo|Matching placebo tablets once daily
275874|NCT00080288|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
275875|NCT00080301|B3|Baseline|Total|Total of all reporting groups
275876|NCT00080301|B2|Baseline|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
275877|NCT00080301|B1|Baseline|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
275878|NCT00080301|P2|Participant Flow|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
275879|NCT00080301|P1|Participant Flow|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
275880|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
275881|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
275882|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
275883|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
275887|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
275888|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
275889|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
275890|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
275891|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
275892|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
275893|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
275894|NCT00080301|E2|Reported Event|Ixabepilone + Capecitabine|
275895|NCT00080301|E1|Reported Event|Capecitabine|
275896|NCT00080470|B3|Baseline|Total|Total of all reporting groups
275897|NCT00080470|B2|Baseline|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
275898|NCT00080470|B1|Baseline|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
275899|NCT00080470|P2|Participant Flow|Control|No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
275900|NCT00080470|P1|Participant Flow|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.
Stimulation On from 45 days post 12 month visit and on."
275901|NCT00080470|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
275902|NCT00080470|O1|Outcome|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
275903|NCT00080470|O2|Outcome|Control|No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
275904|NCT00080470|O1|Outcome|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.
Stimulation On from 45 days post 12 month visit and on."
275905|NCT00080470|E2|Reported Event|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
275906|NCT00080470|E1|Reported Event|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
275907|NCT00080483|B3|Baseline|Total|Total of all reporting groups
275908|NCT00080483|B2|Baseline|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
275909|NCT00080483|B1|Baseline|1Testosterone Only|Testosterone transdermally 5 g a day
275910|NCT00080483|P2|Participant Flow|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
275911|NCT00080483|P1|Participant Flow|1Testosterone Only|Testosterone transdermally 5 g a day
275912|NCT00080483|O2|Outcome|2 The Effects of Testosterone Alone on Structural and Mechanic|"AndroGel transdermally 5 g a day for two years
testosterone: AndroGel transdermally 5 g a day for two years"
275913|NCT00080483|O1|Outcome|1 The Effects of Testosterone Combined With G|"AndroGel transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day
AndroGel plus somatropin: AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years"
275914|NCT00080483|E2|Reported Event|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
275915|NCT00080483|E1|Reported Event|1Testosterone Only|Testosterone transdermally 5 g a day
275916|NCT00080535|B1|Baseline|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
275917|NCT00080535|P1|Participant Flow|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
275918|NCT00080535|O1|Outcome|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
275919|NCT00080535|O1|Outcome|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
275920|NCT00080535|E1|Reported Event|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
275921|NCT00080899|B1|Baseline|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
275922|NCT00080899|P1|Participant Flow|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
275923|NCT00080899|O1|Outcome|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
276402|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
275924|NCT00080899|O1|Outcome|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
275925|NCT00080899|E1|Reported Event|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
275926|NCT00074581|B3|Baseline|Total|Total of all reporting groups
275927|NCT00074581|B2|Baseline|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.
(Same drug regimen as that described in the early-ART arm)
Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
275928|NCT00074581|B1|Baseline|Early-ART|"Participants will begin ART in addition to receiving HIV primary care
Atazanavir: 300 mg taken orally once daily
Didanosine: 400 mg taken orally once daily
Efavirenz: 600 mg taken orally once daily
Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Lamivudine: 300 mg taken orally once daily
Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Stavudine: Dosage depends on weight
Tenofovir disoproxil fumarate: 300 mg taken orally once daily
Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
275929|NCT00074581|P2|Participant Flow|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.
(Same drug regimen as that described in the early-ART arm)
Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
275930|NCT00074581|P1|Participant Flow|Early-ART|"Participants will begin ART in addition to receiving HIV primary care
Atazanavir: 300 mg taken orally once daily
Didanosine: 400 mg taken orally once daily
Efavirenz: 600 mg taken orally once daily
Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Lamivudine: 300 mg taken orally once daily
Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Stavudine: Dosage depends on weight
Tenofovir disoproxil fumarate: 300 mg taken orally once daily
Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
275931|NCT00074581|O2|Outcome|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.
(Same drug regimen as that described in the early-ART arm)
Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
275932|NCT00074581|O1|Outcome|Early-ART|"Participants will begin ART in addition to receiving HIV primary care
Atazanavir: 300 mg taken orally once daily
Didanosine: 400 mg taken orally once daily
Efavirenz: 600 mg taken orally once daily
Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Lamivudine: 300 mg taken orally once daily
Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Stavudine: Dosage depends on weight
Tenofovir disoproxil fumarate: 300 mg taken orally once daily
Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
275933|NCT00074581|O2|Outcome|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.
(Same drug regimen as that described in the early-ART arm)
Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
275934|NCT00074581|O1|Outcome|Early-ART|"Participants will begin ART in addition to receiving HIV primary care
Atazanavir: 300 mg taken orally once daily
Didanosine: 400 mg taken orally once daily
Efavirenz: 600 mg taken orally once daily
Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Lamivudine: 300 mg taken orally once daily
Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Stavudine: Dosage depends on weight
Tenofovir disoproxil fumarate: 300 mg taken orally once daily
Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
275935|NCT00074581|E2|Reported Event|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.
(Same drug regimen as that described in the early-ART arm)
Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
275965|NCT00080938|B1|Baseline|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
275936|NCT00074581|E1|Reported Event|Early-ART|"Participants will begin ART in addition to receiving HIV primary care
Atazanavir: 300 mg taken orally once daily
Didanosine: 400 mg taken orally once daily
Efavirenz: 600 mg taken orally once daily
Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Lamivudine: 300 mg taken orally once daily
Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Stavudine: Dosage depends on weight
Tenofovir disoproxil fumarate: 300 mg taken orally once daily
Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
275937|NCT00074711|B3|Baseline|Total|Total of all reporting groups
275938|NCT00074711|B2|Baseline|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
275939|NCT00074711|B1|Baseline|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
275940|NCT00074711|P2|Participant Flow|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
275941|NCT00074711|P1|Participant Flow|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
275942|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
275943|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
275944|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
275945|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
275946|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
275947|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
275948|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
275949|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
275950|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
275951|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
275952|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
275953|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
275954|NCT00074711|E2|Reported Event|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
275955|NCT00074711|E1|Reported Event|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
275956|NCT00080912|B3|Baseline|Total|Total of all reporting groups
275957|NCT00080912|B2|Baseline|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.
radiation therapy: Given in a single fraction or multiple fractions"
275958|NCT00080912|B1|Baseline|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.
radiation therapy: Given in a single fraction or multiple fractions"
275959|NCT00080912|P2|Participant Flow|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.
radiation therapy: Given in a single fraction or multiple fractions"
275960|NCT00080912|P1|Participant Flow|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.
radiation therapy: Given in a single fraction or multiple fractions"
275961|NCT00080912|O2|Outcome|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.
radiation therapy: Given in a single fraction or multiple fractions"
275962|NCT00080912|O1|Outcome|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.
radiation therapy: Given in a single fraction or multiple fractions"
275963|NCT00080912|E2|Reported Event|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.
radiation therapy: Given in a single fraction or multiple fractions"
275964|NCT00080912|E1|Reported Event|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.
radiation therapy: Given in a single fraction or multiple fractions"
276008|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276009|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
275966|NCT00080938|P1|Participant Flow|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
275967|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
275968|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
275969|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
275970|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
275971|NCT00080938|E1|Reported Event|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
275972|NCT00081159|B3|Baseline|Total|Total of all reporting groups
275973|NCT00081159|B2|Baseline|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
275974|NCT00081159|B1|Baseline|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
275975|NCT00081159|P2|Participant Flow|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
275976|NCT00081159|P1|Participant Flow|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin intravenous (IV) on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
275977|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
275978|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
275979|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
275980|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
275981|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
275982|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
276083|NCT00082342|O3|Outcome|Real tDCS While Off Medication|Bradykinesia measured in the hands and arms while off medication and receiving real tDCS.
275983|NCT00081159|E2|Reported Event|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
275984|NCT00081159|E1|Reported Event|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
275985|NCT00081289|B3|Baseline|Total|Total of all reporting groups
275986|NCT00081289|B2|Baseline|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
275987|NCT00081289|B1|Baseline|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
275988|NCT00081289|P2|Participant Flow|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
275989|NCT00081289|P1|Participant Flow|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy (RT), 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
275990|NCT00081289|O2|Outcome|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
275991|NCT00081289|O1|Outcome|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
275992|NCT00081289|E2|Reported Event|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
275993|NCT00081289|E1|Reported Event|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
275994|NCT00081328|B4|Baseline|Total|Total of all reporting groups
275995|NCT00081328|B3|Baseline|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
275996|NCT00081328|B2|Baseline|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
275997|NCT00081328|B1|Baseline|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
275998|NCT00081328|P3|Participant Flow|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid, encapsulated, provided in weekly packets
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
275999|NCT00081328|P2|Participant Flow|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid, provided encapsulated in weekly packets"
276000|NCT00081328|P1|Participant Flow|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid, provided encapsulated in weekly packets"
276001|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276002|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276003|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
276004|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276005|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276006|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
276007|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276987|NCT00086502|B3|Baseline|Total|Total of all reporting groups
276010|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276011|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276012|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
276013|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276014|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276015|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
276016|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276017|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276018|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
276019|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276020|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276021|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
276022|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276023|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276024|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
276025|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276026|NCT00081328|O2|Outcome|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276027|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
276028|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276029|NCT00081328|O2|Outcome|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276030|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
276031|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276032|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276033|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
276034|NCT00081328|E3|Reported Event|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program
Metformin: capsule, 1000 mg bid
Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
276035|NCT00081328|E2|Reported Event|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone
Metformin: capsule, 1000 mg bid
Rosiglitazone: capsule, 4 mg bid"
276036|NCT00081328|E1|Reported Event|1 Metformin Alone|"Metformin alone
Metformin: capsule, 1000 mg bid"
276037|NCT00081861|B1|Baseline|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
276038|NCT00081861|P1|Participant Flow|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
276040|NCT00081861|E1|Reported Event|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
276041|NCT00081939|B1|Baseline|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
276042|NCT00081939|P1|Participant Flow|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
276043|NCT00081939|O1|Outcome|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
276044|NCT00081939|E1|Reported Event|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
276045|NCT00082017|B1|Baseline|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2
Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.
Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2
Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
276046|NCT00082017|P2|Participant Flow|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|"Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2
Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
276047|NCT00082017|P1|Participant Flow|UCN-01 for T-cell Lymphomas - Cohort 1-Every 28 Days|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2
Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days."
276048|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
276049|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
276050|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
276051|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
276052|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
276053|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
276084|NCT00082342|O2|Outcome|Sham tDCS While on Medication|Bradykinesia measured in the hands and arms while on medication and receiving sham tDCS.
276403|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276054|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
276055|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
276056|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
276057|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
276058|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
276059|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
276060|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
276061|NCT00082017|E1|Reported Event|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2
Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.
Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2
Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
276062|NCT00082173|B3|Baseline|Total|Total of all reporting groups
276063|NCT00082173|B2|Baseline|Control Arm (EMB)|
276064|NCT00082173|B1|Baseline|Experimental Arm (Moxi)|
276065|NCT00082173|P2|Participant Flow|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
276066|NCT00082173|P1|Participant Flow|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
276067|NCT00082173|O2|Outcome|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
276068|NCT00082173|O1|Outcome|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
276069|NCT00082173|O2|Outcome|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
276070|NCT00082173|O1|Outcome|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
276071|NCT00082173|E2|Reported Event|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
276072|NCT00082173|E1|Reported Event|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
276073|NCT00082329|B1|Baseline|AMD 3100 (Mozobil Plerixafor)|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis
AMD 3100 (Mozobil plerixafor) : Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis"
276074|NCT00082329|P1|Participant Flow|AMD 3100 (Mozobil Plerixafor)|Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis
276075|NCT00082329|O1|Outcome|AMD 3100 and G-CSF Responders|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis
We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization."
276076|NCT00082329|E1|Reported Event|AMD 3100 & G-CSF Respnders|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis
We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization."
276077|NCT00082342|B3|Baseline|Total|Total of all reporting groups
276078|NCT00082342|B2|Baseline|Sham tDCS|Subjects received sham transcranial direct current stimulation
276079|NCT00082342|B1|Baseline|Real tDCS|Subjects received real transcranial direct current stimulation
276080|NCT00082342|P2|Participant Flow|Sham tDCS|"Subjects receiving sham transcranial direct current stimulation, had electrodes placed on the subjects head in a manner which caused a temporary tingling sensation without effects on the brain. Subjects receiving sham transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while on medication."
276081|NCT00082342|P1|Participant Flow|Real tDCS|"Transcranial direct current stimulation (tDCS) is a method of non-invasive brain stimulation whereby a direct current is applied to the brain via surface electrodes on the head for a specified time period. It is a form of neurostimulation. Subjects receiving real transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while on medication. A battery driven stimulator, Phoresor II Model PM850 delivered the tDCS through electrodes."
276085|NCT00082342|O1|Outcome|Real tDCS While on Medication|Bradykinesia measured in the hands and arms while on medication and receiving real tDCS.
276086|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|The motor UPDRS score off medication while receiving sham tDCS
276087|NCT00082342|O3|Outcome|Real tDCS While Off Medication|The motor UPDRS score off medication while receiving real tDCS
276088|NCT00082342|O2|Outcome|Sham tDCS While on Medication|The motor UPDRS score on medication while receiving sham tDCS
276089|NCT00082342|O1|Outcome|Real tDCS While on Medication|The motor UPDRS score on medication while receiving real tDCS
276090|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|The total UPDRS score off medication while receiving sham tDCS
276091|NCT00082342|O3|Outcome|Real tDCS While Off Medication|The total UPDRS score off medication while receiving real tDCS
276092|NCT00082342|O2|Outcome|Sham tDCS While on Medication|The total UPDRS score on medication while receiving sham tDCS
276093|NCT00082342|O1|Outcome|Real tDCS While on Medication|The total UPDRS score on medication while receiving real tDCS
276094|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|Timed gait during 10m walking task in subjects off medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
276095|NCT00082342|O3|Outcome|Real tDCS While Off Medication|Timed gait during 10m walking task in subjects off medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
276096|NCT00082342|O2|Outcome|Sham tDCS While on Medication|Timed gait during 10m walking task in subjects on medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
276097|NCT00082342|O1|Outcome|Real tDCS While on Medication|Timed gait during 10m walking task in subjects on medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
276098|NCT00082342|E2|Reported Event|Sham tDCS|Subjects received sham transcranial direct current stimulation
276099|NCT00082342|E1|Reported Event|Real tDCS|Subjects received real transcranial direct current stimulation
276100|NCT00082355|B1|Baseline|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
276101|NCT00082355|P1|Participant Flow|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
276102|NCT00082355|O1|Outcome|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
276103|NCT00082355|O1|Outcome|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
276104|NCT00082355|E1|Reported Event|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
276105|NCT00082368|B1|Baseline|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging
Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.
Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
276106|NCT00082368|P1|Participant Flow|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging
Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.
Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
276107|NCT00082368|O1|Outcome|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging
Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.
Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
276108|NCT00082368|O1|Outcome|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging
Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.
Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
276109|NCT00082368|E1|Reported Event|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging
Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.
Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
276110|NCT00082381|B3|Baseline|Total|Total of all reporting groups
276111|NCT00082381|B2|Baseline|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
276112|NCT00082381|B1|Baseline|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
276113|NCT00082381|P2|Participant Flow|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
276114|NCT00082381|P1|Participant Flow|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
276212|NCT00083174|P2|Participant Flow|Placebo|one tablet daily in am
276115|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
276116|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
276117|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
276118|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
276119|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
276120|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
276121|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
276122|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
276123|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
276124|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
276125|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
276126|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
276127|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
276128|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
276129|NCT00082381|E2|Reported Event|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
276130|NCT00082381|E1|Reported Event|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
276131|NCT00082407|B3|Baseline|Total|Total of all reporting groups
276132|NCT00082407|B2|Baseline|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
276133|NCT00082407|B1|Baseline|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
276134|NCT00082407|P2|Participant Flow|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
276135|NCT00082407|P1|Participant Flow|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
276136|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
276137|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
276138|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
276139|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
276140|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
276141|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
276142|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
276143|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
276144|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
276145|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
276146|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
276147|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
276148|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
276149|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
276150|NCT00082407|E2|Reported Event|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
276151|NCT00082407|E1|Reported Event|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
276152|NCT00082433|B3|Baseline|Total|Total of all reporting groups
276153|NCT00082433|B2|Baseline|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276154|NCT00082433|B1|Baseline|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276155|NCT00082433|P2|Participant Flow|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276156|NCT00082433|P1|Participant Flow|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276157|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276158|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276159|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276160|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276161|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276162|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276163|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276164|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276165|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276166|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276167|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276168|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276169|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276170|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
276171|NCT00082433|E2|Reported Event|Ixabepilone + Capecitabine|
276172|NCT00082433|E1|Reported Event|Capecitabine|
276173|NCT00082758|B4|Baseline|Total|Total of all reporting groups
276174|NCT00082758|B3|Baseline|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).
hu14.18-Interleukin-2 fusion protein : Given IV"
276175|NCT00082758|B2|Baseline|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.
hu14.18-Interleukin-2 fusion protein : Given IV"
276176|NCT00082758|B1|Baseline|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.
hu14.18-Interleukin-2 fusion protein : Given IV"
276177|NCT00082758|P3|Participant Flow|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by meta-iodobenzylguanidine (MIBG) scanning or bone marrow (BM) histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)
hu14.18-Interleukin-2 fusion protein : Given IV"
276178|NCT00082758|P2|Participant Flow|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology.
hu14.18-Interleukin-2 fusion protein : Given IV"
276179|NCT00082758|P1|Participant Flow|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.
hu14.18-Interleukin-2 fusion protein : Given IV"
276180|NCT00082758|O3|Outcome|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)
hu14.18-Interleukin-2 fusion protein : Given IV"
276181|NCT00082758|O2|Outcome|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (meta-iodobenzylguanidine) scanning and/or by bone marrow histology.
hu14.18-Interleukin-2 fusion protein : Given IV"
276182|NCT00082758|O1|Outcome|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.
hu14.18-Interleukin-2 fusion protein : Given IV"
276213|NCT00083174|P1|Participant Flow|Exemestane|one 25 mg tablet daily in am
276214|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
276215|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
276183|NCT00082758|E3|Reported Event|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).
hu14.18-Interleukin-2 fusion protein : Given IV"
276184|NCT00082758|E2|Reported Event|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.
hu14.18-Interleukin-2 fusion protein : Given IV"
276185|NCT00082758|E1|Reported Event|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.
hu14.18-Interleukin-2 fusion protein : Given IV"
276186|NCT00082810|B1|Baseline|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
276187|NCT00082810|P1|Participant Flow|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
276188|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
276189|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
276190|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
276191|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
276192|NCT00082810|E1|Reported Event|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
276193|NCT00082888|B1|Baseline|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
276194|NCT00082888|P1|Participant Flow|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
276195|NCT00082888|O1|Outcome|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
276196|NCT00082888|E1|Reported Event|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
276197|NCT00083122|B3|Baseline|Total|Total of all reporting groups
276198|NCT00083122|B2|Baseline|Group 2 (Platin Sensitive)|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
276199|NCT00083122|B1|Baseline|Group 1 (Platin Resistant)|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
276200|NCT00083122|P2|Participant Flow|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
276201|NCT00083122|P1|Participant Flow|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
276202|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
276203|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
276204|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
276205|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
276206|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
276207|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
276208|NCT00083122|E1|Reported Event|Group 1 and Group 2 Combined|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
276209|NCT00083174|B3|Baseline|Total|Total of all reporting groups
276210|NCT00083174|B2|Baseline|Placebo|one tablet daily in am
276211|NCT00083174|B1|Baseline|Exemestane|one 25 mg tablet daily in am
276230|NCT00083226|B1|Baseline|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.
doxorubicin: Given IV
bortezomib: Given IV"
276231|NCT00083226|P1|Participant Flow|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.
doxorubicin: Given IV
bortezomib: Given IV"
276232|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.
doxorubicin: Given IV
bortezomib: Given IV"
276233|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.
doxorubicin: Given IV
bortezomib: Given IV"
276234|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.
doxorubicin: Given IV
bortezomib: Given IV"
276235|NCT00083226|E1|Reported Event|Doxorubicin+Bortezomib|Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276236|NCT00083382|B1|Baseline|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
276237|NCT00083382|P1|Participant Flow|Thalidomide + Bisphosphonate|"200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
Thalidomide: All Patients will receive thalidomide 200 mg as an oral once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met. Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose)
Pamidronate: Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.
Zometa: Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Dise"
276238|NCT00083382|O1|Outcome|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
276239|NCT00083382|E1|Reported Event|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
276240|NCT00083551|B3|Baseline|Total|Total of all reporting groups
276241|NCT00083551|B2|Baseline|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
276242|NCT00083551|B1|Baseline|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
276243|NCT00083551|P2|Participant Flow|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
276244|NCT00083551|P1|Participant Flow|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
276245|NCT00083551|O2|Outcome|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
276246|NCT00083551|O1|Outcome|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
276247|NCT00083551|E2|Reported Event|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
276248|NCT00083551|E1|Reported Event|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
276249|NCT00083616|B1|Baseline|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
276250|NCT00083616|P1|Participant Flow|Panitumumab (ABX-EGF)|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
276251|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
276252|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
276253|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
276254|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
276255|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
276256|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
276257|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
276258|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
276259|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
276260|NCT00083616|E1|Reported Event|Panitumumab|
276261|NCT00083720|B1|Baseline|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
276262|NCT00083720|P1|Participant Flow|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
276263|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
276264|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
276265|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
276266|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
276267|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
276268|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
276269|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
276270|NCT00083720|E1|Reported Event|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
276271|NCT00083759|B3|Baseline|Total|Total of all reporting groups
276272|NCT00083759|B2|Baseline|Placebo|Placebo IV infusions + methotrexate (MTX)
276273|NCT00083759|B1|Baseline|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
276274|NCT00083759|P2|Participant Flow|Placebo|Placebo IV infusions + methotrexate (MTX)
276275|NCT00083759|P1|Participant Flow|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
276276|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
276277|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
276278|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
276279|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
276280|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
276281|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
276282|NCT00083889|B3|Baseline|Total|Total of all reporting groups
276283|NCT00083889|B2|Baseline|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276284|NCT00083889|B1|Baseline|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276285|NCT00083889|P2|Participant Flow|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276286|NCT00083889|P1|Participant Flow|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276287|NCT00083889|O1|Outcome|Total Drug: SU011248 and SU012662|SU011248 and active metabolite SU012662
276288|NCT00083889|O1|Outcome|SU012662|Active metabolite of SU011248
276289|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle. Intra-subject dose reduction to 35.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276290|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276291|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276292|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276293|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
278855|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
276294|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276295|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276296|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276297|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276298|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276299|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276300|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276301|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276302|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276303|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276304|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276305|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276306|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276307|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276308|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276309|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276310|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276311|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276312|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276313|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276314|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276315|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276316|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276317|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276318|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276319|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276404|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
328407|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
276320|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276321|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276322|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276323|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276324|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276325|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276326|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276327|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276328|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276329|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276330|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276331|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276332|NCT00083889|E2|Reported Event|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
276333|NCT00083889|E1|Reported Event|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
276334|NCT00083915|B3|Baseline|Total|Total of all reporting groups
276335|NCT00083915|B2|Baseline|Mel-DT PACE|
276336|NCT00083915|B1|Baseline|High Dose Melphalan|
276337|NCT00083915|P2|Participant Flow|Mel-DT PACE|
276338|NCT00083915|P1|Participant Flow|High Dose Melphalan|
276339|NCT00083915|O2|Outcome|Mel-DT PACE|
276340|NCT00083915|O1|Outcome|High Dose Melphalan|
276341|NCT00083915|E2|Reported Event|Mel-DT PACE|
276342|NCT00083915|E1|Reported Event|High Dose Melphalan|
276343|NCT00084084|B1|Baseline|Agalsidase Alfa (Cohort 1)|0.2 mg/kg agalsidase alfa infused by IV over 40 (+/- 10) minutes every other week
276344|NCT00084084|P1|Participant Flow|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
276345|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
276346|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
276347|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
276348|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
276349|NCT00084084|E2|Reported Event|Transition Safety Population|A subset of patients from the Safety Population RB who additionally received at least 1 dose of Replagal AF in Phase 2.
276350|NCT00084084|E1|Reported Event|Safety Population RB|Patients in Cohort 1 who received at least 1 dose of Replagal RB in Phase 1 - no data from Phase 2 (Replagal AF) included.
276351|NCT00084136|B4|Baseline|Total|Total of all reporting groups
276352|NCT00084136|B3|Baseline|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276353|NCT00084136|B2|Baseline|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >
> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
276354|NCT00084136|B1|Baseline|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276355|NCT00084136|P3|Participant Flow|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276405|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276406|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276356|NCT00084136|P2|Participant Flow|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >
> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
276357|NCT00084136|P1|Participant Flow|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276358|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276359|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276360|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276361|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276362|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276363|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276364|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276365|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276366|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276367|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276368|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276369|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276370|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276371|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276372|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276373|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276374|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276375|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276376|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276377|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276378|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276379|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276380|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276381|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276382|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276383|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276384|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276385|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276386|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276387|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276388|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276389|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276390|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276391|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276392|NCT00084136|O2|Outcome|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >
> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
276393|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276394|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276395|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276396|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276397|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276398|NCT00084136|O2|Outcome|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >
> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
276407|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276408|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276409|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
276410|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
276411|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
276412|NCT00084136|E3|Reported Event|TDF/FTC+EFV|
276413|NCT00084136|E2|Reported Event|ddI+FTC+ATV|
276414|NCT00084136|E1|Reported Event|ZDV/3TC+EFV|
276415|NCT00084266|B3|Baseline|Total|Total of all reporting groups
276416|NCT00084266|B2|Baseline|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276417|NCT00084266|B1|Baseline|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276418|NCT00084266|P2|Participant Flow|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276419|NCT00084266|P1|Participant Flow|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276420|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276421|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276422|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276423|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276424|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276425|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276426|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276427|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276428|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276429|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276430|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276431|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276432|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276433|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276434|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276463|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
276435|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276436|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276437|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276438|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276439|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276440|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276441|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276442|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276443|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276444|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276445|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276446|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276447|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276448|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276449|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276450|NCT00084266|E2|Reported Event|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276451|NCT00084266|E1|Reported Event|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
276452|NCT00084318|B3|Baseline|Total|Total of all reporting groups
276453|NCT00084318|B2|Baseline|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
276454|NCT00084318|B1|Baseline|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
276455|NCT00084318|P2|Participant Flow|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
276456|NCT00084318|P1|Participant Flow|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
276457|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
276458|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
276459|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
276460|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
276461|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
276462|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
276507|NCT00077857|B3|Baseline|Total|Total of all reporting groups
276464|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
276465|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
276466|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
276467|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
276468|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
276469|NCT00084318|E2|Reported Event|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
276470|NCT00084318|E1|Reported Event|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
276471|NCT00084383|B1|Baseline|GVAX Pancreatic Cancer Vaccine|
276472|NCT00084383|P1|Participant Flow|GVAX Pancreatic Cancer Vaccine|
276473|NCT00084383|O1|Outcome|GVAX Pancreatic Cancer Vaccine|
276474|NCT00084383|O1|Outcome|GVAX Pancreatic Cancer Vaccine|
276475|NCT00084383|E1|Reported Event|GVAX Pancreatic Cancer Vaccine|
276476|NCT00084409|B3|Baseline|Total|Total of all reporting groups
276477|NCT00084409|B2|Baseline|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276478|NCT00084409|B1|Baseline|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276479|NCT00084409|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276480|NCT00084409|P1|Participant Flow|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276481|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276482|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276483|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276484|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276485|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276486|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276487|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276488|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276489|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276490|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276491|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276492|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276493|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276494|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276495|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276496|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276497|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276498|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276499|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276500|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276501|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276502|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276503|NCT00084409|O2|Outcome|Placebo|
276504|NCT00084409|O1|Outcome|Iloprost|
276505|NCT00084409|E2|Reported Event|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276506|NCT00084409|E1|Reported Event|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
276508|NCT00077857|B2|Baseline|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276509|NCT00077857|B1|Baseline|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276510|NCT00077857|P2|Participant Flow|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276511|NCT00077857|P1|Participant Flow|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276512|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276513|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276514|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276515|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276516|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276517|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276518|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276519|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276520|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276521|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276522|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276523|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276524|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276525|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276526|NCT00077857|E2|Reported Event|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276527|NCT00077857|E1|Reported Event|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
276528|NCT00077922|B1|Baseline|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
276529|NCT00077922|P1|Participant Flow|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
276530|NCT00077922|O1|Outcome|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
276531|NCT00077922|O1|Outcome|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
276532|NCT00077922|E1|Reported Event|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
276533|NCT00077974|B1|Baseline|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276534|NCT00077974|P1|Participant Flow|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276535|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276536|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276537|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276538|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276539|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276540|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276541|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276542|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276543|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276544|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276545|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276546|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276547|NCT00077974|E1|Reported Event|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
276548|NCT00084487|B1|Baseline|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
becatecarin : Given IV"
276549|NCT00084487|P1|Participant Flow|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
becatecarin : Given IV"
276550|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
becatecarin : Given IV"
276551|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
becatecarin : Given IV"
276552|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
becatecarin : Given IV"
276553|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
becatecarin : Given IV"
276554|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
becatecarin : Given IV"
276555|NCT00084487|E1|Reported Event|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
becatecarin : Given IV"
276556|NCT00084617|B1|Baseline|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
276557|NCT00084617|P1|Participant Flow|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
276558|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
276559|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
276560|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
276561|NCT00084617|E1|Reported Event|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
276562|NCT00084682|B1|Baseline|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV"
276563|NCT00084682|P1|Participant Flow|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV"
276564|NCT00084682|O1|Outcome|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV"
276565|NCT00084682|E1|Reported Event|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
romidepsin: Given IV"
276566|NCT00084747|B1|Baseline|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
276567|NCT00084747|P1|Participant Flow|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
276568|NCT00084747|O1|Outcome|Bortezomib|bortezomib
276677|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276569|NCT00084747|O1|Outcome|Bortezomib|autologous peripheral blood progenitor cell transplantation with bortezomib maintenance as treatment for intermediate-and advanced-stage multiple myeloma
276570|NCT00084747|E1|Reported Event|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
276571|NCT00085202|B3|Baseline|Total|Total of all reporting groups
276572|NCT00085202|B2|Baseline|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
276573|NCT00085202|B1|Baseline|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
276574|NCT00085202|P2|Participant Flow|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
276575|NCT00085202|P1|Participant Flow|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
276576|NCT00085202|O4|Outcome|ERBB2 Negative & High Risk|14 participants who were ERBB2 negative and in the high risk group
276577|NCT00085202|O3|Outcome|ERBB2 Negative & Average Risk|31 participants who were ERBB2 negative and in the average risk group
276578|NCT00085202|O2|Outcome|ERBB2 Positive & High Risk|23 participants who were ERBB2 positive and in the high risk group
276579|NCT00085202|O1|Outcome|ERBB2 Positive & Average Risk|54 participants who were ERBB2 positive and in the average risk group.
276580|NCT00085202|O3|Outcome|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
276581|NCT00085202|O2|Outcome|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
276582|NCT00085202|O1|Outcome|Overall Study|Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT) were not included in the analysis of ERBB2 tumors.
276583|NCT00085202|E2|Reported Event|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
276584|NCT00085202|E1|Reported Event|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
276585|NCT00085254|B4|Baseline|Total|Total of all reporting groups
276586|NCT00085254|B3|Baseline|Arm 3 - Phase 2 (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276587|NCT00085254|B2|Baseline|Arm 2 - Phase 2 (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276588|NCT00085254|B1|Baseline|Arm 1 - Safety Run In|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276589|NCT00085254|P3|Participant Flow|Arm 3 - Phase II (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (2000mg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cilengitide,Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276590|NCT00085254|P2|Participant Flow|Arm 2 - Phase II (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (500mg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cilengitide, Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276591|NCT00085254|P1|Participant Flow|Arm 1 (Safety Run In)|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276592|NCT00085254|O1|Outcome|Arm 4 (Overall Study)|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276593|NCT00085254|O2|Outcome|Arm 2 - Phase 2 (2000mg)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276594|NCT00085254|O1|Outcome|Arm 1- Phase 2 (500mg)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276595|NCT00085254|O2|Outcome|Arm 2 - Phase 2 (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276596|NCT00085254|O1|Outcome|Arm 1 - Phase 2 (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276597|NCT00085254|O1|Outcome|Arm 1 - Safety Run In|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276598|NCT00085254|O3|Outcome|Arm 3 2000mg (Safety Run-In)|"INITIATION COURSE: Patients receive cilengitide 2000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
Doses of cilengitide: 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.
Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
276599|NCT00085254|O2|Outcome|ARM 2 1000mg (Safety run-in)|"INITIATION COURSE: Patients receive cilengitide 1000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
Doses of cilengitide: 1000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.
Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
276600|NCT00085254|O1|Outcome|Arm 1 500mg (Safety Run In)|"INITIATION COURSE: Patients receive cilengitide 500 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
Doses of cilengitide: 500mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.
Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
276601|NCT00085254|E3|Reported Event|Dose 2000|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276602|NCT00085254|E2|Reported Event|Dose 1000|"INITIATION COURSE: Patients receive cilengitide (1000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276603|NCT00085254|E1|Reported Event|Dose 500|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.
MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Doses of cilengitide: 500mg, 1000mg and 2000mg
Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study
cilengitide: Given IV
temozolomide: Given orally
radiation therapy: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
276604|NCT00085293|B1|Baseline|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.
Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.
Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan
Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
276605|NCT00085293|P1|Participant Flow|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.
Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.
Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan
Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
276606|NCT00085293|O1|Outcome|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.
Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.
Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan
Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
276636|NCT00085540|P2|Participant Flow|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Romidepsin (depsipeptide): 13.3mg/m2
depsipeptide: Given IV"
276607|NCT00085293|O1|Outcome|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.
Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.
Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan
Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
276608|NCT00085293|E1|Reported Event|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.
Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.
Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan
Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
276609|NCT00085410|B1|Baseline|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276610|NCT00085410|P1|Participant Flow|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276611|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276612|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276613|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276614|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276615|NCT00085410|O1|Outcome|Arm I|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
bortezomib: Given IV"
276616|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276617|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276618|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276619|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276620|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276621|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276622|NCT00085410|E1|Reported Event|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
276623|NCT00085423|B1|Baseline|Lymphodepleting Chemotherapy + High Dose IL-2|intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). GM-CSF (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery.
276624|NCT00085423|P1|Participant Flow|Lymphodepleting Chemotherapy + High Dose Interleukin-2|"Lymphodepleting chemotherapy + high dose interleukin-2:
Intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). Granulocyte-macrophage colony-stimulating factor, GM-CSF, (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery."
276625|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
276626|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
276627|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
276628|NCT00085423|E1|Reported Event|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
276629|NCT00085436|B1|Baseline|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
276630|NCT00085436|P1|Participant Flow|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
276631|NCT00085436|O1|Outcome|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
276632|NCT00085436|E1|Reported Event|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
276633|NCT00085540|B3|Baseline|Total|Total of all reporting groups
276634|NCT00085540|B2|Baseline|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Romidepsin (depsipeptide): 13.3mg/m2
depsipeptide: Given IV"
276635|NCT00085540|B1|Baseline|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Dose escalation two dose levels:
Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2
Pharmacokinetics
depsipeptide: Given IV"
276675|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276676|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276637|NCT00085540|P1|Participant Flow|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Dose escalation two dose levels:
Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2
Pharmacokinetics
depsipeptide: Given IV"
276638|NCT00085540|O1|Outcome|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Romidepsin (depsipeptide): 13.3mg/m2
depsipeptide: Given IV"
276639|NCT00085540|O1|Outcome|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Romidepsin (depsipeptide): 13.3mg/m2
depsipeptide: Given IV"
276640|NCT00085540|O1|Outcome|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Dose escalation two dose levels:
Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2
Pharmacokinetics
depsipeptide: Given IV"
276641|NCT00085540|E2|Reported Event|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Romidepsin (depsipeptide): 13.3mg/m2
depsipeptide: Given IV"
276642|NCT00085540|E1|Reported Event|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Dose escalation two dose levels:
Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2
Pharmacokinetics
depsipeptide: Given IV"
276643|NCT00085566|B4|Baseline|Total|Total of all reporting groups
276644|NCT00085566|B3|Baseline|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276645|NCT00085566|B2|Baseline|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276646|NCT00085566|B1|Baseline|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276647|NCT00085566|P3|Participant Flow|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276648|NCT00085566|P2|Participant Flow|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276649|NCT00085566|P1|Participant Flow|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276650|NCT00085566|O3|Outcome|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276651|NCT00085566|O2|Outcome|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276652|NCT00085566|O1|Outcome|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276653|NCT00085566|E3|Reported Event|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276654|NCT00085566|E2|Reported Event|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276655|NCT00085566|E1|Reported Event|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
276656|NCT00085631|B1|Baseline|Overall Study|Due to integrity issues with the current data, baseline measurements of age and gender are reported for the entire cohort, rather than by treatment arm. Age and gender information were available in the current documentation for all 101 patients in this study.
276657|NCT00085631|P3|Participant Flow|Chemoradiation + Hyperthermia|"Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, together with hyperthermia therapy. Completed patients were those who had documented response or follow-up data in the current dataset."
276658|NCT00085631|P2|Participant Flow|Chemoradiation|"Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, without hyperthermia therapy. Completed patients were those who had documented response or follow-up data in the current dataset."
276659|NCT00085631|P1|Participant Flow|Unavailable|"Unavailable refers to patients who were randomized into one of the two treatment groups, but whose assignment could not be deduced from the current data. Completed patients were those who had documented response or follow-up data in the current dataset."
276660|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year overall survival rate in this study.
276661|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year local recurrence-free survival rate in this study.
276662|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year failure-free survival rate in this study.
276663|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the primary tumor response rate in this study.
276664|NCT00085631|E1|Reported Event|Overall Study|Patients from both arms were combined in adverse event reporting.
276665|NCT00085644|B3|Baseline|Total|Total of all reporting groups
276666|NCT00085644|B2|Baseline|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
276667|NCT00085644|B1|Baseline|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
276668|NCT00085644|P3|Participant Flow|Any Adalimumab|40 mg every other week (eow), subcutaneous (SC)
276669|NCT00085644|P2|Participant Flow|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
276670|NCT00085644|P1|Participant Flow|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
276671|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276672|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276673|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276674|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276678|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276679|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276680|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276681|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276682|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276683|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276684|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276685|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276686|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276687|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276688|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276689|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276690|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276691|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276692|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276693|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276694|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276695|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276696|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276697|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276698|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276699|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276700|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276701|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276702|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276703|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276704|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276705|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
276706|NCT00085644|O1|Outcome|Any Adalimumab|By duration of exposure to adalimumab 40 mg every other week, subcutaneous
276707|NCT00085644|O2|Outcome|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
276708|NCT00085644|O1|Outcome|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
276709|NCT00085644|E1|Reported Event|Any Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
276710|NCT00085709|B3|Baseline|Total|Total of all reporting groups
276711|NCT00085709|B2|Baseline|ARA-C+Daunomycin|ARA-C+Daunomycin
276712|NCT00085709|B1|Baseline|Ara-C+Daunomycin+Mylotarg|Ara-C+Daunomycin+Mylotarg
276713|NCT00085709|P2|Participant Flow|ARA-C+Daunomycin|Standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
276714|NCT00085709|P1|Participant Flow|Ara-C+Daunomycin+Mylotarg|Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
276715|NCT00085709|O4|Outcome|Post-consolidation G.O.|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
276716|NCT00085709|O3|Outcome|Ara-C Consolidation|For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
276717|NCT00085709|O2|Outcome|Ara-C+Daunomycin|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
276718|NCT00085709|O1|Outcome|Ara-C+Daunomycin+Mylotarg|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
276719|NCT00085709|O2|Outcome|Ara-C+Daunomycin+Mylotarg|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
276720|NCT00085709|O1|Outcome|Ara-C+Daunomycin|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
276721|NCT00085709|O2|Outcome|Post-consolidation Observation|Patients did not receive any post-consolidation therapy
276722|NCT00085709|O1|Outcome|Post-consolidation GO|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
276723|NCT00085709|E4|Reported Event|Post-consolidation G.O.|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
276724|NCT00085709|E3|Reported Event|Ara-C Consolidation|For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
276725|NCT00085709|E2|Reported Event|Induction 7 + 3|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
278856|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
276726|NCT00085709|E1|Reported Event|Induction 7 + 3 + G.O.|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
276727|NCT00085735|B7|Baseline|Total|Total of all reporting groups
276728|NCT00085735|B6|Baseline|Arm VI (8-21 Years of Age, SDCSI, PFRT)|Eligible patients 8-21 yrs of age, SDCSI, PFRT
276729|NCT00085735|B5|Baseline|Arm V (8-21 Years of Age, SDCSI, IFRT)|Eligible patients 8-21 yrs of age, SDCSI, IFRT
276730|NCT00085735|B4|Baseline|Arm IV (3-7 Years of Age, SDCSI, PFRT)|Eligible patients 3-7 yrs of age, SDCSI, PFRT
276731|NCT00085735|B3|Baseline|Arm III (3-7 Years of Age, SDCSI, IFRT)|Eligible patients 3-7 yrs of age, SDCSI, IFRT
276732|NCT00085735|B2|Baseline|Arm II (3-7 Years of Age, LDCSI, PFRT)|Eligible patients 3-7 yrs of age, LDCSI, PFRT
276733|NCT00085735|B1|Baseline|Arm I (3-7 Years of Age, LDCSI, IFRT)|Eligible patients 3-7 yrs of age, LDCSI, IFRT
276734|NCT00085735|P6|Participant Flow|Arm VI (8-21 Yrs of Age, SDCSI, PFRT)|Patients 8-21 yrs of age, SDCSI, PFRT
276735|NCT00085735|P5|Participant Flow|Arm V (8-21 Yrs of Age, SDCSI, IFRT)|Patients 8-21 years of age, SDCSI, IFRT
276736|NCT00085735|P4|Participant Flow|Arm IV (3-7 Yrs of Age, SDCSI, PFRT)|Patients 3-7 years of age, SDCSI, PFRT
276737|NCT00085735|P3|Participant Flow|Arm III (3-7 Yrs of Age, SDCSI, IFRT)|Patients 3-7 years of age, SDCSI, IFRT
276738|NCT00085735|P2|Participant Flow|Arm II (3-7 Yrs of Age, LDCSI, PFRT)|Patients 3-7 years of age, LDCSI, PFRT
276739|NCT00085735|P1|Participant Flow|Arm I (3-7 Yrs of Age, LDCSI, IFRT)|Patients 3-7 years of age, LDCSI, IFRT
276740|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
276741|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V).
276742|NCT00085735|O2|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)
276743|NCT00085735|O1|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)
276744|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
276745|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V).
276746|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
276747|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
276748|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)
276749|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
276750|NCT00085735|O4|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)
276751|NCT00085735|O3|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
276752|NCT00085735|O2|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)
276753|NCT00085735|O1|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)
276754|NCT00085735|O4|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
276755|NCT00085735|O3|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
276756|NCT00085735|O2|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
276757|NCT00085735|O1|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
276758|NCT00085735|E6|Reported Event|Arm VI (8-21 Years of Age, SDCSI, PFRT)|"See Detailed Description (Arm VI)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)
Vincristine Sulfate: Given IV"
276835|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276836|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276759|NCT00085735|E5|Reported Event|Arm V (8-21 Years of Age, SDCSI, IFRT)|"See Detailed Description (Arm V)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Vincristine Sulfate: Given IV"
276760|NCT00085735|E4|Reported Event|Arm IV (3-7 Years of Age, SDCSI, PFRT)|"See Detailed Description (Arm IV)
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)
Vincristine Sulfate: Given IV"
276761|NCT00085735|E3|Reported Event|Arm III (3-7 Years of Age, SDCSI, IFRT)|"See Detailed Description (Arm III)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Vincristine Sulfate: Given IV"
276762|NCT00085735|E2|Reported Event|Arm II (3-7 Years of Age, LDCSI, PFRT)|"See Detailed Description (Arm II)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)
Vincristine Sulfate: Given IV"
276763|NCT00085735|E1|Reported Event|Arm I (3-7 Years of Age, LDCSI, IFRT)|"See Detailed Description (Arm I)
Cisplatin: Given IV
Craniospinal Irradiation: Undergo craniospinal Irradiation
Cyclophosphamide: Given IV
Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)
Laboratory Biomarker Analysis: Correlative studies
Lomustine: Given orally
Quality-of-Life Assessment: Ancillary studies
Vincristine Sulfate: Given IV"
276764|NCT00085839|B3|Baseline|Total|Total of all reporting groups
276765|NCT00085839|B2|Baseline|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
276766|NCT00085839|B1|Baseline|Erlotinib|Erlotinib 150 mg/day continuous therapy
276767|NCT00085839|P2|Participant Flow|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
276768|NCT00085839|P1|Participant Flow|Erlotinib|Erlotinib 150 mg/day continuous therapy
276769|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
276770|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
276771|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
276772|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
276773|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
276774|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
276775|NCT00085839|E2|Reported Event|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
276776|NCT00085839|E1|Reported Event|Erlotinib|Erlotinib 150 mg/day continuous therapy
276777|NCT00085917|B3|Baseline|Total|Total of all reporting groups
276778|NCT00085917|B2|Baseline|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks
- Total Treatment for 48 weeks"
276779|NCT00085917|B1|Baseline|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)
- Treatment for 48 weeks"
276780|NCT00085917|P2|Participant Flow|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks
- Total Treatment for 48 weeks"
276781|NCT00085917|P1|Participant Flow|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)
- Treatment for 48 weeks"
276782|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks
- Total Treatment for 48 weeks"
276783|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)
- Treatment for 48 weeks"
276784|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks
- Total Treatment for 48 weeks"
276785|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)
- Treatment for 48 weeks"
276786|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks
- Total Treatment for 48 weeks"
276787|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)
- Treatment for 48 weeks"
276837|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276788|NCT00085917|E2|Reported Event|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks
- Total Treatment for 48 weeks"
276789|NCT00085917|E1|Reported Event|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)
- Treatment for 48 weeks"
276790|NCT00086047|B3|Baseline|Total|Total of all reporting groups
276791|NCT00086047|B2|Baseline|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
276792|NCT00086047|B1|Baseline|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
276793|NCT00086047|P2|Participant Flow|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
276794|NCT00086047|P1|Participant Flow|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
276795|NCT00086047|O2|Outcome|Fibromyalgia Education|Consists of education about fibromyalgia and its management
276796|NCT00086047|O1|Outcome|Coping Skills Training|Consists of training in pain management skills using cognitive-behavioral therapy techniques
276797|NCT00086047|E2|Reported Event|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
276798|NCT00086047|E1|Reported Event|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
276799|NCT00086138|B3|Baseline|Total|Total of all reporting groups
276800|NCT00086138|B2|Baseline|Placebo|"Participants will receive placebo matched to sertraline
Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
276801|NCT00086138|B1|Baseline|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.
Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
276802|NCT00086138|P2|Participant Flow|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.
Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
276803|NCT00086138|P1|Participant Flow|Placebo|"Participants will receive placebo matched to sertraline
Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
276804|NCT00086138|O2|Outcome|Placebo|"Participants will receive placebo matched to sertraline
Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
276805|NCT00086138|O1|Outcome|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.
Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
276806|NCT00086138|O2|Outcome|Placebo|"Participants will receive placebo matched to sertraline
Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
276807|NCT00086138|O1|Outcome|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.
Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
276808|NCT00086138|E2|Reported Event|Placebo|"Participants will receive placebo matched to sertraline
Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
276809|NCT00086138|E1|Reported Event|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.
Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
276810|NCT00086190|B4|Baseline|Total|Total of all reporting groups
276811|NCT00086190|B3|Baseline|Placebo|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
276812|NCT00086190|B2|Baseline|Venlafaxine Extended Release|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
276813|NCT00086190|B1|Baseline|Paroxetine|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
276814|NCT00086190|P3|Participant Flow|Placebo|Placebo was made to match treatment options.
276815|NCT00086190|P2|Participant Flow|Venlafaxine Extended Release|Optimal venlafaxine extended release dosage was determined on a per patient basis. The mean dosage at week 12 was 121 +/- 75 mg/day.
276816|NCT00086190|P1|Participant Flow|Paroxetine|Optimal paroxetine dosage was determined on a per patient basis. The mean dosage at week 12 was 24 +/- 11 mg/day.
276817|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276818|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276819|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276820|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276821|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276822|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276823|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276824|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276825|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276826|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276827|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276828|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276829|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276830|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276831|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276832|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276833|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276834|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276838|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276839|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276840|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276841|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276842|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276843|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276844|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276845|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276846|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276847|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276848|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276849|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276850|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276851|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276852|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276853|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276854|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276855|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276856|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276857|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276858|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276859|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276860|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276861|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276862|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276863|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276864|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276865|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
276866|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
276867|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
276868|NCT00086190|E3|Reported Event|Placebo|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
276869|NCT00086190|E2|Reported Event|Venlafaxine Extended Release|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
276870|NCT00086190|E1|Reported Event|Paroxetine|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
276871|NCT00086281|B16|Baseline|Total|Total of all reporting groups
276872|NCT00086281|B15|Baseline|X With M|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
276873|NCT00086281|B14|Baseline|Xyrem|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
276874|NCT00086281|B13|Baseline|Placebo|Placebo was given at bedtime and again 2.5 to 4 hours later
276875|NCT00086281|B12|Baseline|P Then X|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
276876|NCT00086281|B11|Baseline|Z With P Then P Then X With M|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
276877|NCT00086281|B10|Baseline|P Then X Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
276878|NCT00086281|B9|Baseline|X With M Then X Then P Then Z With P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
276879|NCT00086281|B8|Baseline|X Then X Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
276969|NCT00086411|E3|Reported Event|3 Patch+mm|patch and MM with placebo pills
276970|NCT00086411|E2|Reported Event|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
276971|NCT00086411|E1|Reported Event|1: Bup+MM|bupropion and MM with placebo patch
276880|NCT00086281|B7|Baseline|X Then Z With P Then P Then X With M|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
276881|NCT00086281|B6|Baseline|X Then Z With P Then X With M Then P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
276882|NCT00086281|B5|Baseline|P Then X Then P Then X With M Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
276883|NCT00086281|B4|Baseline|Z With P Then P Then X With M Then X|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
276884|NCT00086281|B3|Baseline|X With M Then Z With P Then X Then P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
276885|NCT00086281|B2|Baseline|X Then X With M Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
276886|NCT00086281|B1|Baseline|P Then X Then Z With P Then X With M|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
276887|NCT00086281|P15|Participant Flow|X With M|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
276888|NCT00086281|P14|Participant Flow|Xyrem|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
276889|NCT00086281|P13|Participant Flow|Placebo|Placebo was given at bedtime and again 2.5 to 4 hours later
276890|NCT00086281|P12|Participant Flow|P Then X|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
276891|NCT00086281|P11|Participant Flow|Z With P Then P Then X With M|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
276892|NCT00086281|P10|Participant Flow|P Then X Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
276893|NCT00086281|P9|Participant Flow|X With M Then X Then P Then Z With P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
276894|NCT00086281|P8|Participant Flow|X Then X Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
276895|NCT00086281|P7|Participant Flow|X Then Z With P Then P Then X With M|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
276896|NCT00086281|P6|Participant Flow|X Then Z With P Then X With M Then P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
276972|NCT00086450|B3|Baseline|Total|Total of all reporting groups
276973|NCT00086450|B2|Baseline|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
276974|NCT00086450|B1|Baseline|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
276975|NCT00086450|P2|Participant Flow|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
276897|NCT00086281|P5|Participant Flow|P Then X Then P Then X With M Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
276898|NCT00086281|P4|Participant Flow|Z With P Then P Then X With M Then X|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
276899|NCT00086281|P3|Participant Flow|X With M Then Z With P Then X Then P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
276900|NCT00086281|P2|Participant Flow|X Then X With M Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
276901|NCT00086281|P1|Participant Flow|P Then X Then Z With P Then X With M|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
276902|NCT00086281|O4|Outcome|Zolpidem + Placebo|Zolpidem + Placebo
276903|NCT00086281|O3|Outcome|Xyrem + Modafinil|Xyrem + Modafinil
276904|NCT00086281|O2|Outcome|Xyrem|Xyrem
276905|NCT00086281|O1|Outcome|Placebo|Placebo
276906|NCT00086281|E4|Reported Event|Z + P|Zolpidem + Placebo
276907|NCT00086281|E3|Reported Event|X + M|Xyrem + Modafinil
276908|NCT00086281|E2|Reported Event|Xyrem|Xyrem
276909|NCT00086281|E1|Reported Event|Placebo|Placebo
276910|NCT00086307|B4|Baseline|Total|Total of all reporting groups
276911|NCT00086307|B3|Baseline|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
276912|NCT00086307|B2|Baseline|Escitalopram|Patients receive escitalopram and placebo.
276913|NCT00086307|B1|Baseline|Pramipexole|Patients receive pramipexole and placebo.
276914|NCT00086307|P3|Participant Flow|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
276915|NCT00086307|P2|Participant Flow|Escitalopram|Patients receive escitalopram and placebo.
276916|NCT00086307|P1|Participant Flow|Pramipexole|Patients receive pramipexole and placebo.
276917|NCT00086307|O3|Outcome|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
276918|NCT00086307|O2|Outcome|Escitalopram|Patients receive escitalopram and placebo.
276919|NCT00086307|O1|Outcome|Pramipexole|Patients receive pramipexole and placebo.
276920|NCT00086307|E3|Reported Event|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
276921|NCT00086307|E2|Reported Event|Escitalopram|Patients receive escitalopram and placebo.
276922|NCT00086307|E1|Reported Event|Pramipexole|Patients receive pramipexole and placebo.
276923|NCT00086346|B3|Baseline|Total|Total of all reporting groups
276924|NCT00086346|B2|Baseline|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
276925|NCT00086346|B1|Baseline|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
276926|NCT00086346|P2|Participant Flow|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
276927|NCT00086346|P1|Participant Flow|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
276928|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
276976|NCT00086450|P1|Participant Flow|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
276977|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
276978|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
276979|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
328408|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
276929|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
276930|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
276931|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
276932|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
276933|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
276934|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
276935|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
276936|NCT00086346|E2|Reported Event|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
276937|NCT00086346|E1|Reported Event|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
276938|NCT00086385|B5|Baseline|Total|Total of all reporting groups
276939|NCT00086385|B4|Baseline|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276940|NCT00086385|B3|Baseline|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276941|NCT00086385|B2|Baseline|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276942|NCT00086385|B1|Baseline|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment
Brief Counseling - The counseling intervention consist of five 90-minute group meetings.
No further treatment during Weeks 12-52.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276943|NCT00086385|P4|Participant Flow|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276980|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
276981|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
276982|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
276983|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
276984|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
276944|NCT00086385|P3|Participant Flow|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276945|NCT00086385|P2|Participant Flow|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276946|NCT00086385|P1|Participant Flow|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment
Brief Counseling - The counseling intervention consist of five 90-minute group meetings.
No further treatment during Weeks 12-52.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276947|NCT00086385|O4|Outcome|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276948|NCT00086385|O3|Outcome|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276949|NCT00086385|O2|Outcome|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276950|NCT00086385|O1|Outcome|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment
Brief Counseling - The counseling intervention consist of five 90-minute group meetings.
No further treatment during Weeks 12-52.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276951|NCT00086385|E4|Reported Event|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276952|NCT00086385|E3|Reported Event|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276953|NCT00086385|E2|Reported Event|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276954|NCT00086385|E1|Reported Event|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment
Brief Counseling - The counseling intervention consist of five 90-minute group meetings.
No further treatment during Weeks 12-52.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
276955|NCT00086411|B5|Baseline|Total|Total of all reporting groups
276956|NCT00086411|B4|Baseline|4 Patch+Mayo|patch and Mayo counseling with placebo patch
276957|NCT00086411|B3|Baseline|3 Patch+MM|patch and MM with placebo pills
276958|NCT00086411|B2|Baseline|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
276959|NCT00086411|B1|Baseline|1: Bup+MM|bupropion and MM with placebo patch
276960|NCT00086411|P4|Participant Flow|4 Patch+Mayo|patch and Mayo counseling with placebo patch
276961|NCT00086411|P3|Participant Flow|3 Patch+MM|patch and MM with placebo pills
276962|NCT00086411|P2|Participant Flow|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
276963|NCT00086411|P1|Participant Flow|1 Bup+MM|bupropion and MM with placebo patch
276964|NCT00086411|O4|Outcome|4 Patch+Mayo|patch and Mayo counseling with placebo patch
276965|NCT00086411|O3|Outcome|3 Patch+mm|patch and MM with placebo pills
276966|NCT00086411|O2|Outcome|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
276967|NCT00086411|O1|Outcome|1: Bup+MM|bupropion and MM with placebo patch
276968|NCT00086411|E4|Reported Event|4 Patch+Mayo|patch and Mayo counseling with placebo patch
276988|NCT00086502|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
276989|NCT00086502|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
276990|NCT00086502|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
276991|NCT00086502|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
276992|NCT00086502|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
276993|NCT00086502|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
276994|NCT00086502|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
276995|NCT00086502|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
276996|NCT00086502|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
276997|NCT00086502|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
276998|NCT00086515|B3|Baseline|Total|Total of all reporting groups
276999|NCT00086515|B2|Baseline|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral
tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase
B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with
oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,
in a blinded fashion, to a maximum dose of 15 mg/day."
277000|NCT00086515|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
277001|NCT00086515|P2|Participant Flow|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral
tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase
B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with
oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,
in a blinded fashion, to a maximum dose of 15 mg/day."
277002|NCT00086515|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
277003|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral
tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase
B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with
oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,
in a blinded fashion, to a maximum dose of 15 mg/day."
277004|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
277005|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral
tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase
B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with
oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,
in a blinded fashion, to a maximum dose of 15 mg/day."
277006|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
277007|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral
tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase
B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with
oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,
in a blinded fashion, to a maximum dose of 15 mg/day."
277008|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
277009|NCT00086515|E2|Reported Event|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral
tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase
B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with
oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,
in a blinded fashion, to a maximum dose of 15 mg/day."
277010|NCT00086515|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
277011|NCT00086580|B3|Baseline|Total|Total of all reporting groups
277012|NCT00086580|B2|Baseline|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277013|NCT00086580|B1|Baseline|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277014|NCT00086580|P2|Participant Flow|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277015|NCT00086580|P1|Participant Flow|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277016|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277017|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277018|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277019|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277020|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277021|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277022|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277023|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277024|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277025|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277026|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277027|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277028|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277029|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277030|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277031|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277032|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277061|NCT00086619|P2|Participant Flow|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
277062|NCT00086619|P1|Participant Flow|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
277033|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277034|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277035|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277036|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277037|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277038|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277039|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277040|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277041|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277042|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277043|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277044|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277045|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277046|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277047|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277048|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277049|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277050|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277051|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277052|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277053|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277054|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277055|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277056|NCT00086580|E2|Reported Event|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
277057|NCT00086580|E1|Reported Event|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
277058|NCT00086619|B3|Baseline|Total|Total of all reporting groups
277059|NCT00086619|B2|Baseline|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
277060|NCT00086619|B1|Baseline|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
278857|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
277063|NCT00086619|O2|Outcome|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
277064|NCT00086619|O1|Outcome|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
277065|NCT00086619|O2|Outcome|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
277066|NCT00086619|O1|Outcome|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
277067|NCT00086619|E2|Reported Event|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
277068|NCT00086619|E1|Reported Event|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
277069|NCT00086684|B4|Baseline|Total|Total of all reporting groups
277070|NCT00086684|B3|Baseline|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
277071|NCT00086684|B2|Baseline|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
277072|NCT00086684|B1|Baseline|PLACEBO|
277073|NCT00086684|P3|Participant Flow|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
277074|NCT00086684|P2|Participant Flow|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
277075|NCT00086684|P1|Participant Flow|PLACEBO|
277076|NCT00086684|O3|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
277077|NCT00086684|O2|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
277078|NCT00086684|O1|Outcome|PLACEBO|
277079|NCT00086684|O3|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
277080|NCT00086684|O2|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
277081|NCT00086684|O1|Outcome|PLACEBO|
277082|NCT00086684|E3|Reported Event|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
277083|NCT00086684|E2|Reported Event|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
277084|NCT00086684|E1|Reported Event|PLACEBO|
277085|NCT00086957|B1|Baseline|Dose Levels 1 & 2 - Docetaxel 60 & 75 mg/m^2|"trastuzumab: Cycle 1 loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for subsequent cycles.
docetaxel: 75 mg/m^2 every three weeks, or 60 mg/m^2 every three weeks depending on study findings
gefitinib: 250 mg daily or 250 mg daily on days 2 through 14 depending on study findings"
277086|NCT00086957|P3|Participant Flow|Phase II - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
277087|NCT00086957|P2|Participant Flow|Phase I - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
277088|NCT00086957|P1|Participant Flow|Phase I - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
277089|NCT00086957|O1|Outcome|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
277090|NCT00086957|O1|Outcome|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
277091|NCT00086957|O1|Outcome|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m2 intravenously every 3 weeks.
277092|NCT00086957|O1|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
277093|NCT00086957|O2|Outcome|Phase I: Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
277094|NCT00086957|O1|Outcome|Phase I: Dose Level 1 - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
277095|NCT00086957|E2|Reported Event|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
277096|NCT00086957|E1|Reported Event|Dose Level 1 - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
277097|NCT00086996|B1|Baseline|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
277122|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277123|NCT00087139|E1|Reported Event|Ixabepilone|All patients who received protocol therapy, regardless of eligibility, were evaluated for toxicities.
277124|NCT00087152|B1|Baseline|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
277098|NCT00086996|P1|Participant Flow|Chemo Plus RT, Surgery, Chemo|"Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin 85 mg/m^2 by 2-hour IV infusion days 1, 15, and 29 and fluorouracil (5-FU) 180 mg/m^2/day infusion continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy at 180 centigray (cGy)/day, 5 days a week, for 5 weeks to a total dose of 4,500 cGy.
Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy. The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.
Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin 85 mg/m^2 by 2-hour IV infusion days 1, 15, and 29 and 5-FU 180 mg/m^2/day by 24-hour infusion continuously on days 1-36."
277099|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
277100|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
277101|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
277102|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
277103|NCT00086996|E1|Reported Event|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
277104|NCT00087139|B4|Baseline|Total|Total of all reporting groups
277105|NCT00087139|B3|Baseline|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277106|NCT00087139|B2|Baseline|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277107|NCT00087139|B1|Baseline|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277108|NCT00087139|P3|Participant Flow|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277109|NCT00087139|P2|Participant Flow|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277110|NCT00087139|P1|Participant Flow|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277111|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277112|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277113|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277114|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277115|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277116|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277117|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277118|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277119|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277120|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277121|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
277511|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277125|NCT00087152|P1|Participant Flow|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
277126|NCT00087152|O1|Outcome|Imatinib Mesylate and Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
277127|NCT00087152|O1|Outcome|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
277128|NCT00087152|O1|Outcome|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
277129|NCT00087152|E1|Reported Event|Imatinib Mesylate and Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
277130|NCT00087438|B1|Baseline|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
stereotactic body radiation therapy"
277131|NCT00087438|P1|Participant Flow|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
stereotactic body radiation therapy"
277132|NCT00087438|O1|Outcome|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
stereotactic body radiation therapy"
277133|NCT00087438|E1|Reported Event|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
stereotactic body radiation therapy"
277134|NCT00087490|B3|Baseline|Total|Total of all reporting groups
277135|NCT00087490|B2|Baseline|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277136|NCT00087490|B1|Baseline|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277137|NCT00087490|P2|Participant Flow|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg per kilogram per dose (15 mg/kg/dose) over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277138|NCT00087490|P1|Participant Flow|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 milligram (mg). Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented methicillin-resistant Staphylococcus aureus (MRSA) bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277139|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277140|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277141|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277142|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277143|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277144|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277145|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277146|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277147|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277148|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277149|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277252|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277150|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277151|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277152|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277153|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277154|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277155|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277156|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277157|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277158|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277159|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277160|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277161|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277162|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277163|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277164|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277165|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277166|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277167|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277168|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277169|NCT00087490|E2|Reported Event|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277170|NCT00087490|E1|Reported Event|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
277171|NCT00087516|B4|Baseline|Total|Total of all reporting groups
278858|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
277172|NCT00087516|B3|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
277173|NCT00087516|B2|Baseline|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277174|NCT00087516|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277175|NCT00087516|P4|Participant Flow|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
277176|NCT00087516|P3|Participant Flow|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
277177|NCT00087516|P2|Participant Flow|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277178|NCT00087516|P1|Participant Flow|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277179|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
277180|NCT00087516|O3|Outcome|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
277181|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277182|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277183|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
277184|NCT00087516|O3|Outcome|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
277185|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277186|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277187|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
277188|NCT00087516|O3|Outcome|Placebo/ Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
277189|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277190|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277191|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
277192|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277193|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277253|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277194|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
277195|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277196|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277197|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
277198|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277199|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277200|NCT00087516|E4|Reported Event|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
277201|NCT00087516|E3|Reported Event|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
277202|NCT00087516|E2|Reported Event|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277203|NCT00087516|E1|Reported Event|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
277204|NCT00087529|B3|Baseline|Total|Total of all reporting groups
277205|NCT00087529|B2|Baseline|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277206|NCT00087529|B1|Baseline|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277207|NCT00087529|P2|Participant Flow|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277208|NCT00087529|P1|Participant Flow|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277209|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277210|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277211|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277212|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277213|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277214|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277215|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277254|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277216|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277217|NCT00087529|E2|Reported Event|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277218|NCT00087529|E1|Reported Event|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
277219|NCT00087555|B4|Baseline|Total|Total of all reporting groups
277220|NCT00087555|B3|Baseline|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
277221|NCT00087555|B2|Baseline|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
277222|NCT00087555|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
277223|NCT00087555|P3|Participant Flow|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
277224|NCT00087555|P2|Participant Flow|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
277225|NCT00087555|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
277226|NCT00087555|O3|Outcome|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
277227|NCT00087555|O2|Outcome|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
277228|NCT00087555|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
277229|NCT00087555|E3|Reported Event|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
277230|NCT00087555|E2|Reported Event|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
277231|NCT00087555|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
277232|NCT00087568|B3|Baseline|Total|Total of all reporting groups
277233|NCT00087568|B2|Baseline|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277234|NCT00087568|B1|Baseline|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277235|NCT00087568|P2|Participant Flow|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277236|NCT00087568|P1|Participant Flow|Non-Responders|Participants received Pegasys 180 micrograms (µg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day [mg/day (< or >=75 kg body weight, respectively)], orally in divided doses for 60 weeks.
277237|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277238|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277239|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277240|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277241|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277242|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277243|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277244|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277245|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277246|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277247|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277248|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277249|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277250|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277251|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277512|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
277255|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277256|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277257|NCT00087568|E2|Reported Event|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
277258|NCT00087568|E1|Reported Event|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
277259|NCT00087594|B3|Baseline|Total|Total of all reporting groups
277260|NCT00087594|B2|Baseline|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277261|NCT00087594|B1|Baseline|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277262|NCT00087594|P2|Participant Flow|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277263|NCT00087594|P1|Participant Flow|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277264|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277265|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277266|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277267|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277268|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277269|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277270|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277271|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277272|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277273|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277274|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277275|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277513|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277276|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277277|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277278|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277279|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277280|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277281|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277282|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277283|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277284|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277285|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277286|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277287|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277288|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277289|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277290|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277291|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277292|NCT00087594|E2|Reported Event|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277293|NCT00087594|E1|Reported Event|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
277294|NCT00087607|B3|Baseline|Total|Total of all reporting groups
277341|NCT00087633|O1|Outcome|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
278859|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
277295|NCT00087607|B2|Baseline|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277296|NCT00087607|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277297|NCT00087607|P2|Participant Flow|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b (12 kD) [PEG-Intron] at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin [Rebetol] 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277298|NCT00087607|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a (40 kD) [Pegasys] at a dosage of 180 microgram (μg), subcutaneously (SC), once a week plus Ribavirin [Copegus] 1000 or 1200 milligram (mg)/day), orally, [according to body weight, lesser than or greater than/equal to (< or >/=) 75 kilogram (kg), respectively] twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277299|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277300|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277301|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277302|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277303|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277304|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277342|NCT00087633|O2|Outcome|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
277514|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
277305|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277306|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277307|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277308|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277309|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277310|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277311|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277312|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277313|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277314|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277315|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277316|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277317|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277318|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277319|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277320|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277321|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277322|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277323|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277324|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277325|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277326|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277327|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277328|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277329|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277330|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277331|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277332|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277333|NCT00087607|E2|Reported Event|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277334|NCT00087607|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
277335|NCT00087633|B3|Baseline|Total|Total of all reporting groups
277336|NCT00087633|B2|Baseline|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
277337|NCT00087633|B1|Baseline|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
277338|NCT00087633|P2|Participant Flow|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
277339|NCT00087633|P1|Participant Flow|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
277340|NCT00087633|O2|Outcome|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
277371|NCT00087646|O2|Outcome|Group C + Group D|"Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
277343|NCT00087633|O1|Outcome|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
277344|NCT00087633|E2|Reported Event|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
277345|NCT00087633|E1|Reported Event|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
277346|NCT00087646|B5|Baseline|Total|Total of all reporting groups
277347|NCT00087646|B4|Baseline|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
277348|NCT00087646|B3|Baseline|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
277349|NCT00087646|B2|Baseline|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
277350|NCT00087646|B1|Baseline|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
277351|NCT00087646|P4|Participant Flow|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
277352|NCT00087646|P3|Participant Flow|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
277353|NCT00087646|P2|Participant Flow|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
277354|NCT00087646|P1|Participant Flow|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
277355|NCT00087646|O4|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
277356|NCT00087646|O3|Outcome|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
277357|NCT00087646|O2|Outcome|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
277358|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
277359|NCT00087646|O4|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
277360|NCT00087646|O3|Outcome|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
277361|NCT00087646|O2|Outcome|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
277362|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
277363|NCT00087646|O2|Outcome|Group C + Group D|"Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
277364|NCT00087646|O1|Outcome|Group A + Group B|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks."
277365|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
277366|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
277367|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
277368|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
277369|NCT00087646|O2|Outcome|Group B + Group D|"Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
277370|NCT00087646|O1|Outcome|Group A + Group C|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks."
277508|NCT00088166|B1|Baseline|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
328409|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
277372|NCT00087646|O1|Outcome|Group A + Group B|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks."
277373|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
277374|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
277375|NCT00087646|E4|Reported Event|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
277376|NCT00087646|E3|Reported Event|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
277377|NCT00087646|E2|Reported Event|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
277378|NCT00087646|E1|Reported Event|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
277379|NCT00087672|B1|Baseline|CC-5013|10 mg orally daily
277380|NCT00087672|P1|Participant Flow|CC-5013|10 mg orally daily
277381|NCT00087672|O1|Outcome|CC-5013|10 mg orally daily
277382|NCT00087672|E1|Reported Event|CC-5013|10 mg orally daily
277383|NCT00087685|B1|Baseline|RAD001|10 mg orally daily/28-day cycles
277384|NCT00087685|P1|Participant Flow|RAD001|10 mg orally daily/28-day cycles
277385|NCT00087685|O1|Outcome|RAD001|10 mg orally daily/28-day cycles
277386|NCT00087685|O1|Outcome|RAD001|10 mg orally daily/28-day cycles
277387|NCT00087685|E1|Reported Event|RAD001|10 mg orally daily/28-day cycles
277388|NCT00087698|B1|Baseline|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
277389|NCT00087698|P1|Participant Flow|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
277390|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
277391|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
277392|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
277393|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
277394|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
277395|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
277396|NCT00087698|E1|Reported Event|Pemetrexed|pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 Gy
277397|NCT00081458|B4|Baseline|Total|Total of all reporting groups
277398|NCT00081458|B3|Baseline|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
277399|NCT00081458|B2|Baseline|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
277400|NCT00081458|B1|Baseline|Placebo|Placebo injected subcutaneously daily
277401|NCT00081458|P3|Participant Flow|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
277402|NCT00081458|P2|Participant Flow|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
277403|NCT00081458|P1|Participant Flow|Placebo|Placebo injected subcutaneously daily
277404|NCT00081458|O3|Outcome|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
277405|NCT00081458|O2|Outcome|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
277406|NCT00081458|O1|Outcome|Placebo|Placebo injected subcutaneously daily into the thigh or abdomen
277407|NCT00081458|O3|Outcome|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
277408|NCT00081458|O2|Outcome|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
277409|NCT00081458|O1|Outcome|Placebo|Placebo injectable subcutaneously daily into the thigh or abdomen
277410|NCT00081458|E3|Reported Event|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
277411|NCT00081458|E2|Reported Event|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
277412|NCT00081458|E1|Reported Event|Placebo|Placebo injected subcutaneously daily
277413|NCT00081497|B3|Baseline|Total|Total of all reporting groups
277414|NCT00081497|B2|Baseline|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
277415|NCT00081497|B1|Baseline|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
277509|NCT00088166|P2|Participant Flow|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277416|NCT00081497|P2|Participant Flow|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
277417|NCT00081497|P1|Participant Flow|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
277418|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
277419|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
277420|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
277421|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
277422|NCT00081497|O4|Outcome|Fabrazyme - AGAL02503 (NCT00081497) eGFR ≤60|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
277423|NCT00081497|O3|Outcome|Placebo - AGAL-008-00 (NCT00074984) eGFR ≤60|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry to AGAL02503 (NCT00081497) using only placebo period data from the AGAL-008-00 (NCT00074984) study.
277424|NCT00081497|O2|Outcome|Fabrazyme - AGAL02503 (NCT00081497) eGFR >60|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
277425|NCT00081497|O1|Outcome|Placebo - AGAL-008-00 (NCT00074984) eGFR >60|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) using only placebo period data from the AGAL-008-00 (NCT00074984) study.
277426|NCT00081497|O2|Outcome|Fabrazyme Period - AGAL02503 (NCT00081497)|Placebo patients who had been transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497). 1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months.
277427|NCT00081497|O1|Outcome|Placebo Period - AGAL-008-00 (NCT00074984)|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984).
277428|NCT00081497|E3|Reported Event|Total|
277429|NCT00081497|E2|Reported Event|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
277430|NCT00081497|E1|Reported Event|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
277431|NCT00081653|B3|Baseline|Total|Total of all reporting groups
277432|NCT00081653|B2|Baseline|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
277433|NCT00081653|B1|Baseline|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
277434|NCT00081653|P2|Participant Flow|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
277435|NCT00081653|P1|Participant Flow|Ibandronate 100 Milligrams (mg)|100 mg ibandronate oral (PO) monthly and monthly oral placebo (corresponding to the 150 mg tablet)
277436|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
277437|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandgronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
277438|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
277439|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
277440|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
277441|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
277442|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
277443|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
277444|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
277445|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
277446|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
277447|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
277448|NCT00081653|E2|Reported Event|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
277449|NCT00081653|E1|Reported Event|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
277450|NCT00081731|B3|Baseline|Total|Total of all reporting groups
277451|NCT00081731|B2|Baseline|Stenting|"Stent procedure plus optimal anti-hypertensive therapy
GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
277452|NCT00081731|B1|Baseline|Optimal Medical Therapy|"Optimal anti-hypertensive therapy
Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
277453|NCT00081731|P2|Participant Flow|Stenting|"Stent procedure plus optimal anti-hypertensive therapy
GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
277454|NCT00081731|P1|Participant Flow|Optimal Medical Therapy|"Optimal anti-hypertensive therapy
Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
277455|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy
GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
277456|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy
Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
277457|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy
GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
277458|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy
Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
277459|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy
GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
277460|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy
Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
277461|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy
GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
277462|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy
Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
277463|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy
GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
277464|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy
Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
277465|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy
GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
277466|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy
Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
277467|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy
GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
277468|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy
Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
277469|NCT00081731|E2|Reported Event|Stenting|"Stent procedure plus optimal anti-hypertensive therapy
GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
277470|NCT00081731|E1|Reported Event|Optimal Medical Therapy|"Optimal anti-hypertensive therapy
Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
277471|NCT00081770|B4|Baseline|Total|Total of all reporting groups
277472|NCT00081770|B3|Baseline|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277473|NCT00081770|B2|Baseline|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277474|NCT00081770|B1|Baseline|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277475|NCT00081770|P3|Participant Flow|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277476|NCT00081770|P2|Participant Flow|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277477|NCT00081770|P1|Participant Flow|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277478|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277479|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277480|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277481|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277482|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277510|NCT00088166|P1|Participant Flow|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
277483|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277484|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277485|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277486|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277487|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277488|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277489|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
277490|NCT00081770|E3|Reported Event|PEGASYS 180 ug/wk Plus COPEGUS|
277491|NCT00081770|E2|Reported Event|PegIntron 1.0 ug/kg/wk Plus REBETOL|
277492|NCT00081770|E1|Reported Event|PegIntron 1.5 ug/kg/wk Plus REBETOL|
277493|NCT00088153|B3|Baseline|Total|Total of all reporting groups
277494|NCT00088153|B2|Baseline|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
277495|NCT00088153|B1|Baseline|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).
Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
277496|NCT00088153|P2|Participant Flow|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
277497|NCT00088153|P1|Participant Flow|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).
Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
277498|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.
Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
277499|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
277500|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.
Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
277501|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
277502|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.
Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
277503|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
277504|NCT00088153|E2|Reported Event|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
277505|NCT00088153|E1|Reported Event|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).
Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
277506|NCT00088166|B3|Baseline|Total|Total of all reporting groups
277507|NCT00088166|B2|Baseline|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277682|NCT00090285|B2|Baseline|Placebo|Participants who started the base study vaccination period
277515|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277516|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
277517|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277518|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
277519|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277520|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
277521|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277522|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
277523|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277524|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
277525|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277526|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
277527|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277528|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
277529|NCT00088166|E2|Reported Event|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
277530|NCT00088166|E1|Reported Event|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
277531|NCT00088218|B3|Baseline|Total|Total of all reporting groups
277532|NCT00088218|B2|Baseline|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
277533|NCT00088218|B1|Baseline|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
277534|NCT00088218|P2|Participant Flow|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
277535|NCT00088218|P1|Participant Flow|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
277536|NCT00088218|O2|Outcome|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
277537|NCT00088218|O1|Outcome|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
277538|NCT00088218|E2|Reported Event|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
277539|NCT00088218|E1|Reported Event|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
277540|NCT00090220|B3|Baseline|Total|Total of all reporting groups
277541|NCT00090220|B2|Baseline|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
277542|NCT00090220|B1|Baseline|qHPV Vaccine in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277543|NCT00090220|P6|Participant Flow|Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2)|Participants at sites in Colombia who received placebo or an incomplete regimen of qHPV in the Base Study and open-label qHPV in EXT1 were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study.
277544|NCT00090220|P5|Participant Flow|qHPV Vaccine in Base Study: LTFU (EXT2)|Participants at sites in Colombia who received qHPV vaccination in the Base Study were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study
277545|NCT00090220|P4|Participant Flow|Incomplete qHPV Regimen in Base Study: EXT1|Participants who received an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine beginning at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study) and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
277546|NCT00090220|P3|Participant Flow|Placebo in Base Study: EXT1|Participants who received placebo in the Base Study were offered open-label qHPV vaccine at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study), Month 2, and Month 6 and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
277547|NCT00090220|P2|Participant Flow|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6
277548|NCT00090220|P1|Participant Flow|qHPV Vaccine in Base Study|Participants received Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (qHPV, Gardasil) at Day 1, Month 2, and Month 6
277549|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277550|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277551|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
277552|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277553|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277554|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277555|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
277556|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277557|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
277558|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277559|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
277560|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277561|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277562|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277563|NCT00090220|O2|Outcome|Placebo in the Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
277564|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277565|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277566|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277567|NCT00090220|O2|Outcome|Placebo in the Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
277568|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277569|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
277570|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277571|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277572|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277573|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277574|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277575|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277576|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277577|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277578|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277579|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277580|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277581|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277582|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277583|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277584|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277585|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277586|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277587|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277588|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277589|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277590|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277591|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277592|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277593|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277594|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277595|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277596|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277597|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277598|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277599|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277600|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277683|NCT00090285|B1|Baseline|qHPV Vaccine|Participants who started the base study vaccination period
277601|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277602|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 35 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277603|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277604|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277605|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277606|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277607|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277608|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277609|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277610|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277611|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277612|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277613|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277614|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277615|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277616|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277617|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277618|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277619|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277620|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277621|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
277622|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277623|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277624|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277625|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
277626|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277627|NCT00090220|O2|Outcome|Base Study: Placebo|Participants who received placebo or an incomplete qHPV regimen in the Base Study and were offered open-label qHPV vaccine starting at approximately Month 60 in EXT1
277628|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277629|NCT00090220|O2|Outcome|Placebo in Base Study|Participants who received placebo or an incomplete qHPV regimen in the Base Study and were offered open-label qHPV vaccine starting at approximately Month 60 in EXT1
277630|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277631|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
277632|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277633|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
277634|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
277635|NCT00090220|E4|Reported Event|Long-term Follow-up: EXT2|Participants at sites in Colombia who received qHPV vaccination in the Base Study or in EXT1 were followed from Month 72 up to approximately Month 120 in LTFU (EXT2)
277636|NCT00090220|E3|Reported Event|qHPV Vaccine: EXT1|Participants who received placebo or an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine starting at approximately Month 60 (EXT1) and were followed up to Month 67
277637|NCT00090220|E2|Reported Event|Placebo: Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48
277638|NCT00090220|E1|Reported Event|qHPV Vaccine: Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48
277639|NCT00090233|B3|Baseline|Total|Total of all reporting groups
277640|NCT00090233|B2|Baseline|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277641|NCT00090233|B1|Baseline|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
278860|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
277642|NCT00090233|P2|Participant Flow|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
277643|NCT00090233|P1|Participant Flow|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
277644|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277645|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277646|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277647|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277648|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277649|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277650|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277651|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277652|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277653|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277654|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277655|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277656|NCT00090233|O2|Outcome|Placebo|The number of participants randomized to treatment with Placebo is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
277657|NCT00090233|O1|Outcome|RotaTeq™|The number of participants randomized to treatment with RotaTeq™ is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
277658|NCT00090233|O2|Outcome|Placebo|Participants randomized to treatment with Placebo tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
277659|NCT00090233|O1|Outcome|RotaTeq™|Participants randomized to treatment with RotaTeq™ tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
277660|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277661|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
277662|NCT00090233|E2|Reported Event|Placebo|"Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3."
277663|NCT00090233|E1|Reported Event|RotaTeq™|"Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3."
277664|NCT00090259|B3|Baseline|Total|Total of all reporting groups
277665|NCT00090259|B2|Baseline|Losartan 150 mg|
277666|NCT00090259|B1|Baseline|Losartan 50 mg|
277667|NCT00090259|P2|Participant Flow|Losartan 150 mg|
277668|NCT00090259|P1|Participant Flow|Losartan 50 mg|
277669|NCT00090259|O2|Outcome|Losartan 150 mg|
277670|NCT00090259|O1|Outcome|Losartan 50 mg|
277671|NCT00090259|O2|Outcome|Losartan 150 mg|
277672|NCT00090259|O1|Outcome|Losartan 50 mg|
277673|NCT00090259|O2|Outcome|Losartan 150 mg|
277674|NCT00090259|O1|Outcome|Losartan 50 mg|
277675|NCT00090259|O2|Outcome|Losartan 150 mg|
277676|NCT00090259|O1|Outcome|Losartan 50 mg|
277677|NCT00090259|O2|Outcome|Losartan 150 mg|
277678|NCT00090259|O1|Outcome|Losartan 50 mg|
277679|NCT00090259|E2|Reported Event|Losartan 150 mg|
277680|NCT00090259|E1|Reported Event|Losartan 50 mg|
277681|NCT00090285|B3|Baseline|Total|Total of all reporting groups
277684|NCT00090285|P4|Participant Flow|EXT1: Incomplete qHPV Regimen in Base Study|Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.
277685|NCT00090285|P3|Participant Flow|EXT1: Placebo in Base Study|Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at EXT1 Day 1, Month 2 and Month 6. Participants were followed to EXT1 Month 7.
277686|NCT00090285|P2|Participant Flow|Placebo in Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36."
277687|NCT00090285|P1|Participant Flow|qHPV Vaccine in Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36."
277688|NCT00090285|O2|Outcome|Placebo: Base Study and Followup|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 placebo injection in the base study."
277689|NCT00090285|O1|Outcome|qHPV Vaccine: Base Study and Followup|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 qHPV vaccination in the base study."
277690|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
277691|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
277692|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
277693|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
277694|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
277695|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
277696|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
277697|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
277698|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
277699|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
277700|NCT00090285|E3|Reported Event|qHPV Vaccine: EXT1|Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7. The at-risk population was participants who received ≥ 1 qHPV vaccination in EXT1 and had follow-up data.
277701|NCT00090285|E2|Reported Event|Placebo: Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 placebo injection in the base study."
277702|NCT00090285|E1|Reported Event|qHPV Vaccine: Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 qHPV vaccination in the base study."
277703|NCT00090363|B4|Baseline|Total|Total of all reporting groups
277704|NCT00090363|B3|Baseline|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
277705|NCT00090363|B2|Baseline|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
277706|NCT00090363|B1|Baseline|Placebo|Matching placebo oral tablet once daily, with best supportive care
277707|NCT00090363|P3|Participant Flow|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
277708|NCT00090363|P2|Participant Flow|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
277709|NCT00090363|P1|Participant Flow|Placebo|Matching placebo oral tablet once daily, with best supportive care
277710|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
277711|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
277712|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
277713|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
277714|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
277715|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
277716|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
277717|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
277718|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
277719|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
277720|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
277721|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
277722|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
277723|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
277724|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
277725|NCT00090363|E3|Reported Event|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
277726|NCT00090363|E2|Reported Event|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
277727|NCT00090363|E1|Reported Event|Placebo|Matching placebo oral tablet once daily, with best supportive care
277728|NCT00090402|B4|Baseline|Total|Total of all reporting groups
277729|NCT00090402|B3|Baseline|Fish Oil Plus Lipoic Acid|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
277730|NCT00090402|B2|Baseline|Fish Oil|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
277731|NCT00090402|B1|Baseline|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
277732|NCT00090402|P3|Participant Flow|Fish Oil Plus Lipoic Acid|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
277733|NCT00090402|P2|Participant Flow|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
277734|NCT00090402|P1|Participant Flow|Fish Oil|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
277735|NCT00090402|O3|Outcome|Fish Oil and Lipoic Acid|"Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 lipoic acid (LA) capsule in the racemic form per day (600 mg).
Fish Oil and Lipoic acid: Fish oil concentrate(daily dose 3 grams containing 675 milligrams docosahexanoic acid and 975 milligrams eicosapentanoic acid) plus lipoic acid (daily dose 600 milligrams)taken for 12 months"
277736|NCT00090402|O2|Outcome|Fish Oil|"Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 placebo-lipoic acid (LA) capsule (600 mg) per day. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.
Fish Oil: Fish oil concentrate (daily dose 3 grams containing 675 milligrams docosahexanoic acid and 975 milligrams eicosapentanoic acid) taken for 12 months."
277737|NCT00090402|O1|Outcome|Placebo|"Three 1-gram placebo-fish oil capsule per day and 1 placebo-lipoic acid (LA) capsule per day (600 mg). Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil concentrate. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.
Placebo: Soybean oil 3 grams a day and placebo lipoic acid 600 milligrams a day taken for 12 months."
277738|NCT00090402|O3|Outcome|Fish Oil Plus Lipoic Acid|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
277739|NCT00090402|O2|Outcome|Fish Oil|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
277740|NCT00090402|O1|Outcome|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
277741|NCT00090402|O3|Outcome|Fish Oil Plus Lipoic Acid|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
277742|NCT00090402|O2|Outcome|Fish Oil|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
277743|NCT00090402|O1|Outcome|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
277744|NCT00090402|E3|Reported Event|Fish Oil Plus Lipoic Acid|Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 lipoic acid (LA) capsule in the racemic form per day (600 mg).
277745|NCT00090402|E2|Reported Event|Fish Oil|Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 placebo-lipoic acid (LA) capsule (600 mg) per day. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.
277782|NCT00090545|P1|Participant Flow|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.
400 mg BAY 43-9006 orally twice daily in 28 day cycles."
328410|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
277746|NCT00090402|E1|Reported Event|Placebo|Three 1-gram placebo-fish oil capsule per day and 1 placebo-lipoic acid (LA) capsule per day (600 mg). Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil concentrate. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate
277747|NCT00090493|B1|Baseline|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|Treatment will consist of receiving peptide (small pieces of proteins) vaccinations as a shot just under the skin (subcutaneous). Purpose is to generate anti-myeloma T-cells with will kill only myeloma cells. Three injections of peptide will be given subcutaneously together with the adjuvant GM-CSF at 2-week intervals.
277748|NCT00090493|P1|Participant Flow|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.
MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.
MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
277749|NCT00090493|O1|Outcome|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.
MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.
MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
277750|NCT00090493|E1|Reported Event|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.
MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.
MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
277751|NCT00090519|B3|Baseline|Total|Total of all reporting groups
277752|NCT00090519|B2|Baseline|Placebo|QD oral for up to 36 months
277753|NCT00090519|B1|Baseline|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277754|NCT00090519|P2|Participant Flow|Placebo|QD oral for up to 36 months
277755|NCT00090519|P1|Participant Flow|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277756|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
277757|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277758|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
277759|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277760|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
277761|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277762|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
277763|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277764|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
277765|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277766|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
277767|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277768|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
277769|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277770|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
277771|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277772|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
277773|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277774|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
277775|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277776|NCT00090519|E2|Reported Event|Placebo|QD oral for up to 36 months
277777|NCT00090519|E1|Reported Event|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
277778|NCT00090545|B3|Baseline|Total|Total of all reporting groups
277779|NCT00090545|B2|Baseline|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles"
277780|NCT00090545|B1|Baseline|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.
Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
277781|NCT00090545|P2|Participant Flow|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles."
277924|NCT00090844|O2|Outcome|no Triptorelin|No GnRH analogue (triptorelin) during chemotherapy
328411|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
277783|NCT00090545|O2|Outcome|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
277784|NCT00090545|O1|Outcome|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.
Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
277785|NCT00090545|O2|Outcome|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles."
277786|NCT00090545|O1|Outcome|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.
400 mg BAY 43-9006 orally twice daily in 28 day cycles."
277787|NCT00090545|E2|Reported Event|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles."
277788|NCT00090545|E1|Reported Event|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.
Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
277789|NCT00090584|B3|Baseline|Total|Total of all reporting groups
277790|NCT00090584|B2|Baseline|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
277791|NCT00090584|B1|Baseline|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
277792|NCT00090584|P2|Participant Flow|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
277793|NCT00090584|P1|Participant Flow|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
277794|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
277795|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
277796|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
277797|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
277798|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
277799|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
277800|NCT00090584|O2|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
277801|NCT00090584|O1|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
277802|NCT00090584|O6|Outcome|Drug Only at 8 Months|8 month value for women randomized to drug only
277803|NCT00090584|O5|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
277804|NCT00090584|O4|Outcome|Drug Only at Baseline|Baseline value for women randomized to drug only
277805|NCT00090584|O3|Outcome|Combiniation at 8 Months|8 months value from women in combination arm
277806|NCT00090584|O2|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
277807|NCT00090584|O1|Outcome|Combination at Baseline|Baseline value for women in combination therapy
277808|NCT00090584|O6|Outcome|Drug Only at 8 Months|8 month value for women randomized to drug only
277809|NCT00090584|O5|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
277810|NCT00090584|O4|Outcome|Drug Only at Baseline|Baseline value for women randomized to drug only
277811|NCT00090584|O3|Outcome|Combiniation at 8 Months|8 months value from women in combination arm
277812|NCT00090584|O2|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
277813|NCT00090584|O1|Outcome|Combination at Baseline|Baseline value for women in combination therapy
277814|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
277815|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
277816|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
277817|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
277818|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
277819|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
277820|NCT00090584|E2|Reported Event|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
277821|NCT00090584|E1|Reported Event|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
277822|NCT00090610|B3|Baseline|Total|Total of all reporting groups
277823|NCT00090610|B2|Baseline|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
277824|NCT00090610|B1|Baseline|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
277825|NCT00090610|P2|Participant Flow|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
277826|NCT00090610|P1|Participant Flow|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
277979|NCT00091169|P2|Participant Flow|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.
placebo: Given orally"
277827|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
277828|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
277829|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
277830|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
277831|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
277832|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
277833|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
277834|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
277835|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
277836|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
277837|NCT00090610|E2|Reported Event|Arm2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
277838|NCT00090610|E1|Reported Event|Arm 1|Docetaxel 30 mg/m2 intravenously (IV) on Days 1 and 8, combined with carboplatin area under the concentration versus time curve (AUC) 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression (DP) (whichever occurred first).
277839|NCT00090753|B3|Baseline|Total|Total of all reporting groups
277840|NCT00090753|B2|Baseline|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
277841|NCT00090753|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
277842|NCT00090753|P2|Participant Flow|Comparator ESA|Patients received the same comparator erythropoiesis stimulating agent (ESA) [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
277843|NCT00090753|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta (Mircera) via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
277844|NCT00090753|O2|Outcome|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
277845|NCT00090753|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
277846|NCT00090753|O2|Outcome|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
277925|NCT00090844|O1|Outcome|Triptorelin|"GnRH analogue (triptorelin) during chemotherapy
triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
277926|NCT00090844|E2|Reported Event|no Triptorelin|No GnRH analogue (triptorelin) during chemotherapy
277847|NCT00090753|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
277848|NCT00090753|E2|Reported Event|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
277849|NCT00090753|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
277850|NCT00090766|B4|Baseline|Total|Total of all reporting groups
277851|NCT00090766|B3|Baseline|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277852|NCT00090766|B2|Baseline|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277853|NCT00090766|B1|Baseline|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277854|NCT00090766|P3|Participant Flow|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277855|NCT00090766|P2|Participant Flow|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277856|NCT00090766|P1|Participant Flow|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * body surface area [BSA] * creatinine clearance [CrCLS]).
277857|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277858|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277859|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277860|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277861|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277862|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277863|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277864|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277865|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277927|NCT00090844|E1|Reported Event|Triptorelin|"GnRH analogue (triptorelin) during chemotherapy
triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
277928|NCT00090857|B3|Baseline|Total|Total of all reporting groups
277866|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277867|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277868|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277869|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277870|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277871|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277872|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277873|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277874|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277875|NCT00090766|O1|Outcome|Overall Study|All participants who received at least one dose of valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277876|NCT00090766|O1|Outcome|Overall Study|All participants who received at least one dose of valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277877|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277878|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277879|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277880|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277881|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277882|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277883|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277884|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277885|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277886|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Participants aged >= 12 years received a once daily oral dose (solution or tablets) of valganciclovir from the time of kidney transplant for up to 100 days post-transplant. Dose (in mg) was calculated using the algorithm (7 * body surface area * creatinine clearance).
277887|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277888|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277889|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277890|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277891|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277892|NCT00090766|E3|Reported Event|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277893|NCT00090766|E2|Reported Event|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277894|NCT00090766|E1|Reported Event|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
277895|NCT00090779|B3|Baseline|Total|Total of all reporting groups
277896|NCT00090779|B2|Baseline|DT Arm|DT arm participants received no Treatment
277897|NCT00090779|B1|Baseline|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
277898|NCT00090779|P2|Participant Flow|DT Arm|On step 1, DT arm participants received no Treatment,unless subsequent disease progression criteria were met. Participants in DT arm who met clinical, virologic or immunologic criteria for treatment initiation entered step 2 and initiated ART. At the time of the end of original randomized study, study participants in DT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
277899|NCT00090779|P1|Participant Flow|IT Arm|On step 1, IT arm participants received 36 weeks of emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily. Participants in IT arm who met clinical, virologic or immunologic criteria for treatment re-initiation entered step 2 and re-initiated ART. At the time of the end of original randomized study, study participants in IT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
277900|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
277901|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
277902|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
277903|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
277904|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
277905|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
277906|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
277907|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
277908|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
277909|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
277910|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
277911|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
277912|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
277913|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
277914|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
277915|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
277916|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
277917|NCT00090779|E2|Reported Event|DT Arm|DT arm participants received no Treatment
277918|NCT00090779|E1|Reported Event|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
277919|NCT00090844|B3|Baseline|Total|Total of all reporting groups
277920|NCT00090844|B2|Baseline|no Triptorelin|no GnRH analogue (triptorelin) during chemotherapy
277921|NCT00090844|B1|Baseline|Triptorelin|GnRH analogue (triptorelin) during chemotherapy
277922|NCT00090844|P2|Participant Flow|no Triptorelin|No Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy
277923|NCT00090844|P1|Participant Flow|Triptorelin|"Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy
triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
277929|NCT00090857|B2|Baseline|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277930|NCT00090857|B1|Baseline|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277931|NCT00090857|P2|Participant Flow|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277932|NCT00090857|P1|Participant Flow|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277933|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277934|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277935|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277936|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277937|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277938|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277939|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277940|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277941|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277942|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277943|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277944|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277945|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277946|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277947|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277948|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277977|NCT00091169|B2|Baseline|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.
placebo: Given orally"
277978|NCT00091169|B1|Baseline|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
levocarnitine: Given orally"
277949|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277950|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277951|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277952|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277953|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277954|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277955|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277956|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277957|NCT00090857|E2|Reported Event|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277958|NCT00090857|E1|Reported Event|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
277959|NCT00090987|B1|Baseline|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
277960|NCT00090987|P1|Participant Flow|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
277961|NCT00090987|O1|Outcome|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
277962|NCT00090987|E1|Reported Event|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
277963|NCT00091026|B3|Baseline|Total|Total of all reporting groups
277964|NCT00091026|B2|Baseline|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
277965|NCT00091026|B1|Baseline|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
277966|NCT00091026|P2|Participant Flow|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
277967|NCT00091026|P1|Participant Flow|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
277968|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
277969|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
277970|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
277971|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
277972|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
277973|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
277974|NCT00091026|E2|Reported Event|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
277975|NCT00091026|E1|Reported Event|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
277976|NCT00091169|B3|Baseline|Total|Total of all reporting groups
277980|NCT00091169|P1|Participant Flow|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
levocarnitine: Given orally"
277981|NCT00091169|O2|Outcome|Arm II|"Patients receive oral placebo twice daily on weeks 1-4.
placebo: Given orally"
277982|NCT00091169|O1|Outcome|Arm I|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
levocarnitine: Given orally"
277983|NCT00091169|O2|Outcome|Arm II|"Patients receive oral placebo twice daily on weeks 1-4.
placebo: Given orally"
277984|NCT00091169|O1|Outcome|Arm I|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
levocarnitine: Given orally"
277985|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.
placebo: Given orally"
277986|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
levocarnitine: Given orally"
277987|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.
placebo: Given orally"
277988|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
levocarnitine: Given orally"
277989|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.
placebo: Given orally"
277990|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
levocarnitine: Given orally"
277991|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.
placebo: Given orally"
277992|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
levocarnitine: Given orally"
277993|NCT00091169|E2|Reported Event|Placebo|Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
277994|NCT00091169|E1|Reported Event|Levocarnitine|Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally
277995|NCT00091260|B1|Baseline|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
277996|NCT00091260|P1|Participant Flow|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
277997|NCT00091260|O1|Outcome|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
277998|NCT00091260|O1|Outcome|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
dexamethasone: dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
277999|NCT00091260|O1|Outcome|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
278000|NCT00091260|E1|Reported Event|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
278001|NCT00091273|B1|Baseline|Single Arm|
278002|NCT00091273|P1|Participant Flow|Single Arm|
278003|NCT00091273|O1|Outcome|Single Arm|
278004|NCT00091273|O1|Outcome|Single Arm|
278005|NCT00091273|O1|Outcome|Single Arm|
278006|NCT00091273|E1|Reported Event|Single Arm|
278007|NCT00091390|B1|Baseline|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
278008|NCT00091390|P1|Participant Flow|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
278009|NCT00091390|O1|Outcome|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
278010|NCT00091390|E1|Reported Event|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
278011|NCT00091442|B3|Baseline|Total|Total of all reporting groups
278012|NCT00091442|B2|Baseline|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
278013|NCT00091442|B1|Baseline|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
278014|NCT00091442|P2|Participant Flow|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
278015|NCT00091442|P1|Participant Flow|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
278016|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
278017|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
328412|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
278018|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
278019|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
278020|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
278021|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
278022|NCT00091442|E2|Reported Event|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
278023|NCT00091442|E1|Reported Event|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
278024|NCT00091507|B3|Baseline|Total|Total of all reporting groups
278025|NCT00091507|B2|Baseline|Placebo|Dextrose 5%
278026|NCT00091507|B1|Baseline|GIK --|GIK = glucose-insulin-potassium
278027|NCT00091507|P2|Participant Flow|Placebo|Dextrose 5%
278028|NCT00091507|P1|Participant Flow|GIK --|GIK = glucose-insulin-potassium
278029|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
278030|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
278031|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
278032|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
278033|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
278034|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
278035|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
278036|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
278037|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
278038|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
278039|NCT00091507|E2|Reported Event|Placebo|Dextrose 5%
278040|NCT00091507|E1|Reported Event|GIK --|GIK = glucose-insulin-potassium
278041|NCT00091572|B3|Baseline|Total|Total of all reporting groups
278042|NCT00091572|B2|Baseline|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
278043|NCT00091572|B1|Baseline|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
278044|NCT00091572|P2|Participant Flow|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
278045|NCT00091572|P1|Participant Flow|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
278046|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
278047|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
278048|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
278049|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
278050|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
278051|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
278052|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
278053|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
278054|NCT00091572|E2|Reported Event|Dacarbazine|
278055|NCT00091572|E1|Reported Event|Temozolomide|
278056|NCT00091793|B3|Baseline|Total|Total of all reporting groups
278057|NCT00091793|B2|Baseline|Placebo|
278058|NCT00091793|B1|Baseline|Denosumab 60 mg Q6M|
278059|NCT00091793|P2|Participant Flow|Placebo|
278060|NCT00091793|P1|Participant Flow|Denosumab 60 mg Q6M|
278061|NCT00091793|O2|Outcome|Placebo|
278062|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
278063|NCT00091793|O2|Outcome|Placebo|
278064|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
278065|NCT00091793|O2|Outcome|Placebo|
278066|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
278067|NCT00091793|O2|Outcome|Placebo|
278068|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
278069|NCT00091793|O2|Outcome|Placebo|
278070|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
278071|NCT00091793|O2|Outcome|Placebo|
278072|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
278073|NCT00091793|O2|Outcome|Placebo|
278074|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
278075|NCT00091793|O2|Outcome|Placebo|
278076|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
278077|NCT00091793|O2|Outcome|Placebo|
278078|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
278079|NCT00091793|E2|Reported Event|Denosumab 60 mg Q6M|
278080|NCT00091793|E1|Reported Event|Placebo|
278081|NCT00091819|B3|Baseline|Total|Total of all reporting groups
278082|NCT00091819|B2|Baseline|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
278083|NCT00091819|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
278084|NCT00091819|P2|Participant Flow|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
278137|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278085|NCT00091819|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
278086|NCT00091819|O2|Outcome|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
278087|NCT00091819|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
278088|NCT00091819|E2|Reported Event|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
278089|NCT00091819|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
278090|NCT00091832|B7|Baseline|Total|Total of all reporting groups
278091|NCT00091832|B6|Baseline|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278092|NCT00091832|B5|Baseline|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278093|NCT00091832|B4|Baseline|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278094|NCT00091832|B3|Baseline|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278095|NCT00091832|B2|Baseline|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278096|NCT00091832|B1|Baseline|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278097|NCT00091832|P6|Participant Flow|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278098|NCT00091832|P5|Participant Flow|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278099|NCT00091832|P4|Participant Flow|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278100|NCT00091832|P3|Participant Flow|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278101|NCT00091832|P2|Participant Flow|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278102|NCT00091832|P1|Participant Flow|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion (IV)
278103|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278104|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278105|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278106|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278107|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278108|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278109|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278110|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278111|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278112|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278113|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278114|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278115|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278116|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278117|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278118|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278119|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278120|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278121|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278122|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278123|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278124|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278125|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278126|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278127|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278128|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278129|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278130|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278131|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278132|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278133|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278134|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278135|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278136|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278138|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278139|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278140|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278141|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278142|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278143|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278144|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278145|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278146|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278147|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278148|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278149|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278150|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278151|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278152|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278153|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278154|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278155|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278156|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278157|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278158|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278159|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278160|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278161|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278162|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278163|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278164|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278165|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278166|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278167|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278168|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278169|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278170|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278171|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278172|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278173|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278174|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278175|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278176|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278177|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278178|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278179|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278180|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278181|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278182|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278183|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278184|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278185|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278186|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278187|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278188|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278189|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278190|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278191|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278192|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278193|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278194|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278195|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278196|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278197|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278198|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278199|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278200|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278201|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278202|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278203|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278204|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278205|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278206|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278207|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278208|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278209|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278210|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
278211|NCT00091832|E6|Reported Event|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
278212|NCT00091832|E5|Reported Event|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
278213|NCT00091832|E4|Reported Event|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
278214|NCT00091832|E3|Reported Event|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
278215|NCT00091832|E2|Reported Event|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
278216|NCT00091832|E1|Reported Event|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion.
278217|NCT00091949|B3|Baseline|Total|Total of all reporting groups
278218|NCT00091949|B2|Baseline|Placebo|placebo: an inactive substance
278219|NCT00091949|B1|Baseline|Pioglitazone|pioglitazone: a thiazolidinedione drug
278220|NCT00091949|P2|Participant Flow|Placebo|placebo: an inactive substance
278221|NCT00091949|P1|Participant Flow|Pioglitazone|pioglitazone: a thiazolidinedione drug
278222|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
278223|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
278224|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
278225|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
278226|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
278227|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
278228|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
278229|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
278230|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
278231|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
278232|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
278233|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
278234|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
278235|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
278236|NCT00091949|E2|Reported Event|Placebo|placebo: an inactive substance
278237|NCT00091949|E1|Reported Event|Pioglitazone|pioglitazone: a thiazolidinedione drug
278238|NCT00091962|B4|Baseline|Total|Total of all reporting groups
278239|NCT00091962|B3|Baseline|Non-Depressed Control|Observational only
278240|NCT00091962|B2|Baseline|Depressed Usual Care|"Control group will receive usual care for depression
Usual Care: Usual care for depression"
278241|NCT00091962|B1|Baseline|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager
Counseling: Counseling program
Pharmacotherapy: Medication to treat depression"
278242|NCT00091962|P3|Participant Flow|Non-Depressed Control Group|
278243|NCT00091962|P2|Participant Flow|Depressed Usual Care|"Control group will receive usual care for depression
Usual Care: Usual care for depression"
278244|NCT00091962|P1|Participant Flow|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager
Counseling: Counseling program
Pharmacotherapy: Medication to treat depression"
278245|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
278246|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
278247|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist
Psychoeducation; Treatment recommendations: Counseling program
Pharmacotherapy: Medication to treat depression"
278248|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
278249|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
278250|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist
Psychoeducation; Treatment recommendations: Counseling program
Pharmacotherapy: Medication to treat depression"
278428|NCT00092495|O1|Outcome|Girls 10-15 Years|
278251|NCT00091962|O3|Outcome|Non-Depressed Control Group|Non-depressed groups as Control to see the natural course of recovery after CABG
278252|NCT00091962|O2|Outcome|Depressed Usual Care|"Control group will receive usual care for depression
Usual Care: Usual care for depression"
278253|NCT00091962|O1|Outcome|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager
Counseling: Counseling program
Pharmacotherapy: Medication to treat depression"
278254|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
278255|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
278256|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist
Psychoeducation; Treatment recommendations: Counseling program
Pharmacotherapy: Medication to treat depression"
278257|NCT00091962|E3|Reported Event|Non-Depressed Control|Non-depressed control group with no intervention
278258|NCT00091962|E2|Reported Event|Depressed Usual Care|"Usual care for depression by patients' PCP"
278259|NCT00091962|E1|Reported Event|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist
Psychoeducation; Treatment recommendations: Counseling program
Pharmacotherapy: Medication to treat depression"
278260|NCT00092118|B3|Baseline|Total|Total of all reporting groups
278261|NCT00092118|B2|Baseline|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
278262|NCT00092118|B1|Baseline|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
278263|NCT00092118|P2|Participant Flow|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
278264|NCT00092118|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
278265|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
278266|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
278267|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
278268|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
278269|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
278270|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
278271|NCT00092118|E2|Reported Event|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
278272|NCT00092118|E1|Reported Event|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
278273|NCT00092131|B1|Baseline|Overall Study Population|All randomized patients
278274|NCT00092131|P2|Participant Flow|Placebo in Period I Then Montelukast 10 mg in Period II|A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
278275|NCT00092131|P1|Participant Flow|Montelukast 10 mg in Period I Then Placebo in Period II|A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose.
278276|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278277|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278278|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278279|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278280|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278281|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278282|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278283|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278284|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278285|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278286|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278287|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278288|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278289|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278290|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278291|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278292|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278293|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278294|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278295|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278296|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278297|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278298|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
278299|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
278861|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
278300|NCT00092131|E2|Reported Event|Placebo in Period I Then Montelukast 10 mg in Period II|A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
278301|NCT00092131|E1|Reported Event|Montelukast 10 mg in Period I Then Placebo in Period II|A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose.
278302|NCT00092417|B3|Baseline|Total|Total of all reporting groups
278303|NCT00092417|B2|Baseline|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
278304|NCT00092417|B1|Baseline|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
278305|NCT00092417|P2|Participant Flow|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
278306|NCT00092417|P1|Participant Flow|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
278307|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
278308|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
278309|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
278310|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
278311|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
278312|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
278313|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
278314|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
278315|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
278316|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
278317|NCT00092417|E2|Reported Event|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
278318|NCT00092417|E1|Reported Event|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
278319|NCT00092443|B3|Baseline|Total|Total of all reporting groups
278320|NCT00092443|B2|Baseline|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
278321|NCT00092443|B1|Baseline|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
278322|NCT00092443|P2|Participant Flow|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
278323|NCT00092443|P1|Participant Flow|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
278324|NCT00092443|O10|Outcome|Placebo Matching RotaTeq™ (SNA - P1A)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
278325|NCT00092443|O9|Outcome|Placebo Matching RotaTeq™ (SNA - G4)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
278326|NCT00092443|O8|Outcome|Placebo Matching RotaTeq™ (SNA - G3)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
278327|NCT00092443|O7|Outcome|Placebo Matching RotaTeq™ (SNA - G2)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
278328|NCT00092443|O6|Outcome|Placebo Matching RotaTeq™ (SNA - G1)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
278329|NCT00092443|O5|Outcome|RotaTeq™ at Expiry Potency (SNA - P1A)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
278330|NCT00092443|O4|Outcome|RotaTeq™ at Expiry Potency (SNA - G4)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
278331|NCT00092443|O3|Outcome|RotaTeq™ at Expiry Potency (SNA - G3)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
278332|NCT00092443|O2|Outcome|RotaTeq™ at Expiry Potency (SNA - G2)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
278333|NCT00092443|O1|Outcome|RotaTeq™ at Expiry Potency (SNA - G1)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
278429|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278334|NCT00092443|O2|Outcome|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
278335|NCT00092443|O1|Outcome|RotaTeq™ at Expiry Potency (≈1.1 x 107 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
278336|NCT00092443|E2|Reported Event|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
278337|NCT00092443|E1|Reported Event|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
278338|NCT00092456|B5|Baseline|Total|Total of all reporting groups
278339|NCT00092456|B4|Baseline|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278340|NCT00092456|B3|Baseline|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278341|NCT00092456|B2|Baseline|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278342|NCT00092456|B1|Baseline|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278343|NCT00092456|P4|Participant Flow|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
278344|NCT00092456|P3|Participant Flow|RotaTeq™ Lot 3|Three oral doses (~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278345|NCT00092456|P2|Participant Flow|RotaTeq™ Lot 2|Three oral doses (~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278346|NCT00092456|P1|Participant Flow|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278347|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278348|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278349|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278350|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278351|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278352|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278353|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278354|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278355|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278356|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278357|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278358|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278359|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278360|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278361|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278362|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278363|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278364|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278365|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278366|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278367|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278368|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278369|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278370|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278371|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278372|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278373|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278374|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278375|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278376|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278377|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278378|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278379|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278380|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278381|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278382|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278383|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278384|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278385|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278386|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278430|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
278387|NCT00092456|E4|Reported Event|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278388|NCT00092456|E3|Reported Event|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278389|NCT00092456|E2|Reported Event|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278390|NCT00092456|E1|Reported Event|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
278391|NCT00092495|B5|Baseline|Total|Total of all reporting groups
278392|NCT00092495|B4|Baseline|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278393|NCT00092495|B3|Baseline|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
278394|NCT00092495|B2|Baseline|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278395|NCT00092495|B1|Baseline|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278396|NCT00092495|P5|Participant Flow|Extension Study|"Extension Study: This group includes 12 subjects who participated in the base study and received either a partial dose formulation of the quadrivalent HPV vaccine in the base study and did not meet the protocol specified criteria for seroconversion, or subjects who, due to pregnancy, received 1 or 2 doses of the quadrivalent HPV vaccine in the base study and remained in the study through Month 7. The Extension Period began after all patients had completed the Month 7 follow-up period. Subjects designated as Completed Period are those who at the end of the study had received three injections of quadrivalent HPV vaccine and completed all follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
278397|NCT00092495|P4|Participant Flow|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278398|NCT00092495|P3|Participant Flow|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
278399|NCT00092495|P2|Participant Flow|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278400|NCT00092495|P1|Participant Flow|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278401|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278402|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
278403|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278404|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278405|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278406|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
278407|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278408|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278409|NCT00092495|O3|Outcome|Women 16-23 Years|
278410|NCT00092495|O2|Outcome|Boys 10-15 Years|
278411|NCT00092495|O1|Outcome|Girls 10-15 Years|
278412|NCT00092495|O3|Outcome|Women 16-23 Years|
278413|NCT00092495|O2|Outcome|Boys 10-15 Years|
278414|NCT00092495|O1|Outcome|Girls 10-15 Years|
278415|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278416|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
278417|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278418|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278419|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278420|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
278421|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278422|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278423|NCT00092495|O3|Outcome|Women 16-23 Years|
278424|NCT00092495|O2|Outcome|Boys 10-15 Years|
278425|NCT00092495|O1|Outcome|Girls 10-15 Years|
278426|NCT00092495|O3|Outcome|Women 16-23 Years|
278427|NCT00092495|O2|Outcome|Boys 10-15 Years|
278431|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278432|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278433|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278434|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
278435|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278436|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278437|NCT00092495|O3|Outcome|Women 16-23 Years|
278438|NCT00092495|O2|Outcome|Boys 10-15 Years|
278439|NCT00092495|O1|Outcome|Girls 10-15 Years|
278440|NCT00092495|O3|Outcome|Women 16-23 Years|
278441|NCT00092495|O2|Outcome|Boys 10-15 Years|
278442|NCT00092495|O1|Outcome|Girls 10-15 Years|
278443|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278444|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
278445|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278446|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278447|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278448|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
278449|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
278450|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278451|NCT00092495|O3|Outcome|Women 16-23 Years|
278452|NCT00092495|O2|Outcome|Boys 10-15 Years|
278453|NCT00092495|O1|Outcome|Girls 10-15 Years|
278454|NCT00092495|O3|Outcome|Women 16-23 Years|
278455|NCT00092495|O2|Outcome|Boys 10-15 Years|
278456|NCT00092495|O1|Outcome|Girls 10-15 Years|
278457|NCT00092495|E4|Reported Event|100% Formulation|Subjects in this group received a 100% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278458|NCT00092495|E3|Reported Event|60% Formulation|Subjects in this group received a 60% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278459|NCT00092495|E2|Reported Event|40% Formulation|Subjects in this group received a 40% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278460|NCT00092495|E1|Reported Event|20% Formulation|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
278461|NCT00092521|B4|Baseline|Total|Total of all reporting groups
278462|NCT00092521|B3|Baseline|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278463|NCT00092521|B2|Baseline|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278464|NCT00092521|B1|Baseline|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278465|NCT00092521|P4|Participant Flow|Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension|"This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as Completed Period are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
278466|NCT00092521|P3|Participant Flow|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278862|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
328413|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
278467|NCT00092521|P2|Participant Flow|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population."
278468|NCT00092521|P1|Participant Flow|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent Human papillomavirus (HPV) vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278469|NCT00092521|O2|Outcome|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278470|NCT00092521|O1|Outcome|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278471|NCT00092521|O2|Outcome|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278472|NCT00092521|O1|Outcome|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278473|NCT00092521|E4|Reported Event|Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension|"This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as Completed Period are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
278474|NCT00092521|E3|Reported Event|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278475|NCT00092521|E2|Reported Event|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278476|NCT00092521|E1|Reported Event|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278477|NCT00092534|B3|Baseline|Total|Total of all reporting groups
278478|NCT00092534|B2|Baseline|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278479|NCT00092534|B1|Baseline|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278480|NCT00092534|P3|Participant Flow|Extension Study|"This group includes 581 subjects who received placebo during the base study, (Group 2-Base Study) and 13 additional subjects who were randomized to the active vaccine arm of the base study (from Group 1-Base Study), but received fewer than the full three doses of Quadrivalent HPV vaccine during the base study. Subjects designated as Completed Period are those who received three doses of Quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
278497|NCT00092547|B2|Baseline|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
278863|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
278481|NCT00092534|P2|Participant Flow|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278482|NCT00092534|P1|Participant Flow|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278483|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278484|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278485|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278486|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278487|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278488|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278489|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278490|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278491|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278492|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278493|NCT00092534|E3|Reported Event|Extension Study|"This group includes 581 subjects who received placebo during the base study, (Group 2-Base Study) and 13 additional subjects who were randomized to the active vaccine arm of the base study (from Group 1-Base Study), but received fewer than the full three doses of Quadrivalent HPV vaccine during the base study. Subjects designated as Completed Period are those who received three doses of Quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
Extension study includes subjects from Group 2-Base Study who were vaccinated with quadrivalent HPV vaccine.
No data on non-serious adverse events were collected on this group during the extension study, hence no data are entered for them in the table."
278494|NCT00092534|E2|Reported Event|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278495|NCT00092534|E1|Reported Event|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
278496|NCT00092547|B3|Baseline|Total|Total of all reporting groups
278864|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
278498|NCT00092547|B1|Baseline|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278499|NCT00092547|P3|Participant Flow|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278500|NCT00092547|P2|Participant Flow|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.
278501|NCT00092547|P1|Participant Flow|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.
278502|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278503|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278504|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278505|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278506|NCT00092547|O1|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278507|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278508|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278509|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represent participants randomized to the qHPV vaccine group
278510|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278511|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278512|NCT00092547|O1|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278513|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278514|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278515|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278516|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278517|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278518|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278519|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278520|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278521|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278522|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278523|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278524|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278525|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278526|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278527|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278528|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278529|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278530|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278531|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278532|NCT00092547|O2|Outcome|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
278533|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278534|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
278535|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278536|NCT00092547|O2|Outcome|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
278537|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
278538|NCT00092547|E4|Reported Event|qHPV Vaccine in Extension: Extension and Long-term Follow-up|Participants who received placebo in the Base Study and three 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36 in the Extension Study. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
278539|NCT00092547|E3|Reported Event|qHPV Vaccine in Base: Extension and Long-term Follow-up|Participants who received qHPV in the Base Study. No study treatment was administered after Month 6 for these participants. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
278540|NCT00092547|E2|Reported Event|Placebo in Base: Vaccine Phase and Follow-up|"Participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo vaccine at Day 1, Month 2, and Month 6, and had safety followup.
Adverse events are reported for this group from Day 1 to Month 30."
278541|NCT00092547|E1|Reported Event|qHPV Vaccine in Base: Vaccine Phase and Follow-up|Participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of qHPV at Day 1, Month 2, and Month 6, and had safety follow-up. Adverse events are reported for this group from Day 1 to Month 30.
278542|NCT00092677|B3|Baseline|Total|Total of all reporting groups
278543|NCT00092677|B2|Baseline|Placebo|
278544|NCT00092677|B1|Baseline|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278545|NCT00092677|P2|Participant Flow|Placebo|
278546|NCT00092677|P1|Participant Flow|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278547|NCT00092677|O2|Outcome|Placebo|
278548|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278549|NCT00092677|O2|Outcome|Placebo|
278550|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278551|NCT00092677|O2|Outcome|Placebo|
278552|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278553|NCT00092677|O2|Outcome|Placebo|
278554|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278555|NCT00092677|O2|Outcome|Placebo|
278556|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278557|NCT00092677|O2|Outcome|Placebo|
278558|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278559|NCT00092677|O2|Outcome|Placebo|
278560|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278561|NCT00092677|O2|Outcome|Placebo|
278562|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278563|NCT00092677|O2|Outcome|Placebo|
278564|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278565|NCT00092677|O2|Outcome|Placebo|
278566|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278567|NCT00092677|O2|Outcome|Placebo|
278568|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278569|NCT00092677|O2|Outcome|Placebo|
278570|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278571|NCT00092677|O2|Outcome|Placebo|
278572|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278573|NCT00092677|O2|Outcome|Placebo|
278574|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278575|NCT00092677|O2|Outcome|Placebo|
278576|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278577|NCT00092677|O2|Outcome|Placebo|
278578|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278579|NCT00092677|O2|Outcome|Placebo|
278580|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278581|NCT00092677|O2|Outcome|Placebo|
278582|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278583|NCT00092677|O2|Outcome|Placebo|
278584|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278585|NCT00092677|E2|Reported Event|Placebo|
278586|NCT00092677|E1|Reported Event|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
278865|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
278587|NCT00084838|B1|Baseline|Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
278588|NCT00084838|P1|Participant Flow|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
278589|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278590|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278591|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278592|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278593|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278644|NCT00085098|B1|Baseline|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
278866|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
278594|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278595|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278596|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278597|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278598|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278599|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278600|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278664|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278601|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278602|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278603|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278604|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
filgrastim"
278605|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)
Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
278606|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
278607|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
278665|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278608|NCT00084838|E1|Reported Event|Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT.
Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.
Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
278609|NCT00084864|B5|Baseline|Total|Total of all reporting groups
278610|NCT00084864|B4|Baseline|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally"
278611|NCT00084864|B3|Baseline|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally"
278612|NCT00084864|B2|Baseline|Arm 2|"No study drugs before surgery.
clinical observation: No intervention before surgery"
278613|NCT00084864|B1|Baseline|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally"
278614|NCT00084864|P4|Participant Flow|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally"
278615|NCT00084864|P3|Participant Flow|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally"
278616|NCT00084864|P2|Participant Flow|Arm 2|"No study drugs before surgery.
clinical observation: No intervention before surgery"
278617|NCT00084864|P1|Participant Flow|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally"
278618|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally"
278619|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally"
278620|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.
clinical observation: No intervention before surgery"
278621|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally"
278622|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally"
278623|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally"
278624|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.
clinical observation: No intervention before surgery"
278625|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally"
278626|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally"
278627|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally"
278628|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.
clinical observation: No intervention before surgery"
278629|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally"
278630|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally"
278631|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally"
278632|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.
clinical observation: No intervention before surgery"
278633|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally"
278634|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally"
278635|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally"
278636|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.
clinical observation: No intervention before surgery"
278637|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally"
278638|NCT00084864|E4|Reported Event|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally"
278639|NCT00084864|E3|Reported Event|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally"
278640|NCT00084864|E2|Reported Event|Arm 2|"No study drugs before surgery.
clinical observation: No intervention before surgery"
278641|NCT00084864|E1|Reported Event|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally"
278642|NCT00085098|B3|Baseline|Total|Total of all reporting groups
278643|NCT00085098|B2|Baseline|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.
Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.
Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.
Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.
Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
278645|NCT00085098|P2|Participant Flow|Regimen B (Chemotherapy Plus Radiotherapy)|Courses 1,2:Patients (PTS) receive carboplatin IV over 1 hour on days 1-2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses. Within 3 weeks of completing chemotherapy, PTS with complete response (CR) undergo low-dose radiation therapy 5 days a week for 5 weeks. PTS with minimal residual disease (MRD), a PR, or stable disease (SD) receive chemotherapy courses 3,4. Courses 3,4:PTS receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2-3 and filgrastim (G-CSF) subcutaneous (SC) or IV on day 4 continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. PTS achieving a CR or MRD proceed to reduced-dose radiotherapy. PTS with a partial response (PR), SD or progressive disease (PD) are restaged and may undergo standard radiation therapy as in regimen A.Reduced-dose radiation therapy: Within 6 weeks of starting course 4, PTS undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks.
278646|NCT00085098|P1|Participant Flow|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
278647|NCT00085098|O2|Outcome|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.
Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.
Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.
Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.
Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
278648|NCT00085098|O1|Outcome|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
278649|NCT00085098|E2|Reported Event|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.
Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.
Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.
Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.
Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
278650|NCT00085098|E1|Reported Event|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
278651|NCT00093015|B3|Baseline|Total|Total of all reporting groups
278652|NCT00093015|B2|Baseline|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278653|NCT00093015|B1|Baseline|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278654|NCT00093015|P2|Participant Flow|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278655|NCT00093015|P1|Participant Flow|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278656|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278657|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278658|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278659|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278660|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278661|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278662|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278663|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278666|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278667|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278668|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278669|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278670|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278671|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278672|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278673|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278674|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278675|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278676|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
278677|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
278678|NCT00093015|E2|Reported Event|Darbepoetin Alfa|
278679|NCT00093015|E1|Reported Event|Placebo|
278680|NCT00093041|B7|Baseline|Total|Total of all reporting groups
278681|NCT00093041|B6|Baseline|Zalutumumab 8 mg/kg|
278682|NCT00093041|B5|Baseline|Zalutumumab 4 mg/kg|
278683|NCT00093041|B4|Baseline|Zalutumumab 2 mg/kg|
278684|NCT00093041|B3|Baseline|Zalutumumab 1 mg/kg|
278685|NCT00093041|B2|Baseline|Zalutumumab 0.5 mg/kg|
278686|NCT00093041|B1|Baseline|Zalutumumab 0.15 mg/kg|
278687|NCT00093041|P6|Participant Flow|Zalutumumab 8 mg/kg|
278688|NCT00093041|P5|Participant Flow|Zalutumumab 4 mg/kg|
278689|NCT00093041|P4|Participant Flow|Zalutumumab 2 mg/kg|
278690|NCT00093041|P3|Participant Flow|Zalutumumab 1 mg/kg|
278691|NCT00093041|P2|Participant Flow|Zalutumumab 0.5 mg/kg|
278692|NCT00093041|P1|Participant Flow|Zalutumumab 0.15 mg/kg|
278693|NCT00093041|O6|Outcome|Zalutumumab 8 mg/kg|
278694|NCT00093041|O5|Outcome|Zalutumumab 4 mg/kg|
278695|NCT00093041|O4|Outcome|Zalutumumab 2 mg/kg|
278696|NCT00093041|O3|Outcome|Zalutumumab 1 mg/kg|
278697|NCT00093041|O2|Outcome|Zalutumumab 0.5 mg/kg|
278698|NCT00093041|O1|Outcome|Zalatumumab 0.15 mg/kg|
278699|NCT00093041|O6|Outcome|Zalutumumab 8 mg/kg|
278700|NCT00093041|O5|Outcome|Zalutumumab 4 mg/kg|
278701|NCT00093041|O4|Outcome|Zalutumumab 2 mg/kg|
278702|NCT00093041|O3|Outcome|Zalutumumab 1 mg/kg|
278703|NCT00093041|O2|Outcome|Zalutumumab 0.5 mg/kg|
278704|NCT00093041|O1|Outcome|Zalatumumab 0.15 mg/kg|
278705|NCT00093041|E6|Reported Event|Zalutumumab 8 mg/kg|
278706|NCT00093041|E5|Reported Event|Zalutumumab 4 mg/kg|
278707|NCT00093041|E4|Reported Event|Zalutumumab 2 mg/kg|
278708|NCT00093041|E3|Reported Event|Zalutumumab 1 mg/kg|
278709|NCT00093041|E2|Reported Event|Zalutumumab 0.5 mg/kg|
278710|NCT00093041|E1|Reported Event|Zalutumumab 0.15 mg/kg|
278711|NCT00093145|B1|Baseline|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
278724|NCT00095173|P3|Participant Flow|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
278867|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
328414|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
278712|NCT00093145|P1|Participant Flow|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
278713|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
278714|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
278715|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
278716|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
278717|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
278718|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
278719|NCT00093145|E1|Reported Event|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
278720|NCT00095173|B1|Baseline|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes,once every 2 weeks for 3 doses, then monthly up to 6 months unless a disease flare discontinued the patient earlier.
278721|NCT00095173|P6|Participant Flow|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278722|NCT00095173|P5|Participant Flow|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278723|NCT00095173|P4|Participant Flow|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) or once a month for up to 5 years (Period C).
278868|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
278869|NCT00095238|O6|Outcome|Placebo Baseline All Classes Combined|
278725|NCT00095173|P2|Participant Flow|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare (Period B).
278726|NCT00095173|P1|Participant Flow|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
278727|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278728|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278729|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
278730|NCT00095173|O1|Outcome|Abatacept (All Participants in Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278731|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
278732|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
278733|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses.
278734|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278735|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278736|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
278737|NCT00095173|O1|Outcome|Abatacept (All Participants in Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278738|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
278739|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
278740|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
278741|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278742|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278743|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
278744|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
278745|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
278746|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278747|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
278772|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week cycles) until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278748|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
278749|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
278750|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
278751|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
278752|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
278753|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
278754|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
278755|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
278756|NCT00095173|E4|Reported Event|Abatacept (Period A)/Placebo (Period B)|"All participants treated with Abatacept in Period A, placebo in Period B, who may or may not have entered Period C.
Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion. If participants entered Period C, they were treated with Abatacept,10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years."
278757|NCT00095173|E3|Reported Event|Abatacept (Period A/Period B)|"All participants treated with Abatacept in Periods A and B who may or may not have entered Period C.
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses, then once a month for 6 months. If participants entered Period C, treatment continued once a month for up to 5 years."
278758|NCT00095173|E2|Reported Event|Abatacept (Period A/Period C)|"Participants treated in Period A, not eligible to continue into Period B, but re-entered in Period C.
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C)."
278759|NCT00095173|E1|Reported Event|Abatacept (Only Period A)|"Participants treated in Period A but did not in Periods B or C.
Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses."
278760|NCT00095199|B5|Baseline|Total|Total of all reporting groups
278761|NCT00095199|B4|Baseline|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278762|NCT00095199|B3|Baseline|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278763|NCT00095199|B2|Baseline|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278764|NCT00095199|B1|Baseline|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278765|NCT00095199|P4|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278766|NCT00095199|P3|Participant Flow|Cetuximab and Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278767|NCT00095199|P2|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
278768|NCT00095199|P1|Participant Flow|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles, until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278769|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278770|NCT00095199|O3|Outcome|Cetuximab + Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Day 1 of every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
278771|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278773|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278870|NCT00095238|O5|Outcome|Placebo Class III or IV|
278774|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week cycles).
278775|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278776|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
278777|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278778|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week cycles), after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278779|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278780|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278781|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278782|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278783|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278784|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278785|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278786|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278787|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278788|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
278789|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278790|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278791|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278792|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278793|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278794|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278795|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278796|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278797|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278798|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278799|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278800|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
278854|NCT00095238|O1|Outcome|Placebo - Month 6|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 6
278801|NCT00095199|E4|Reported Event|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278802|NCT00095199|E3|Reported Event|Cetuximab and Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
278803|NCT00095199|E2|Reported Event|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
278804|NCT00095199|E1|Reported Event|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles, until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
278805|NCT00095212|B3|Baseline|Total|Total of all reporting groups
278806|NCT00095212|B2|Baseline|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278807|NCT00095212|B1|Baseline|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278808|NCT00095212|P2|Participant Flow|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278809|NCT00095212|P1|Participant Flow|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278810|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278811|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278812|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278813|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278814|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278815|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278816|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278817|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278818|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278819|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278820|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278821|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278822|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278823|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278824|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278825|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278826|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278827|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278828|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278829|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278830|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278831|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278832|NCT00095212|E2|Reported Event|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
278833|NCT00095212|E1|Reported Event|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
278834|NCT00095238|B3|Baseline|Total|Total of all reporting groups
278835|NCT00095238|B2|Baseline|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
278836|NCT00095238|B1|Baseline|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
278837|NCT00095238|P2|Participant Flow|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
278838|NCT00095238|P1|Participant Flow|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
278839|NCT00095238|O4|Outcome|Placebo no ACE-I Use|
278840|NCT00095238|O3|Outcome|Irbesartan no ACE-I Use|
278841|NCT00095238|O2|Outcome|Placebo + ACE-I Use|
278842|NCT00095238|O1|Outcome|Irbesartan + ACE-I Use|
278843|NCT00095238|O6|Outcome|Irbesartan - Month 66|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 66
278844|NCT00095238|O5|Outcome|Placebo - Month 66|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 66
278845|NCT00095238|O4|Outcome|Irbesartan - Month 54|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 54
278846|NCT00095238|O3|Outcome|Placebo - Month 54|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 54
278847|NCT00095238|O2|Outcome|Irbesartan - Month 42|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 42
278848|NCT00095238|O1|Outcome|Placebo - Month 42|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 42
278849|NCT00095238|O6|Outcome|Irbesartan - Month 30|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 30
278850|NCT00095238|O5|Outcome|Placebo - Month 30|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 30
278851|NCT00095238|O4|Outcome|Irbesartan - Month 18|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 18
278852|NCT00095238|O3|Outcome|Placebo - Month 18|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 18
278853|NCT00095238|O2|Outcome|Irbesartan - Month 6|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 6
278873|NCT00095238|O2|Outcome|Irbesartan Class III or IV|Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
278874|NCT00095238|O1|Outcome|Irbesartan Baseline Class I or II|Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
278875|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
278876|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
278877|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
278878|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
278879|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
278880|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
278881|NCT00095238|O4|Outcome|Irbesartan - Month 14|Irbesartan cohort with measurements at Baseline and Month 14.
278882|NCT00095238|O3|Outcome|Placebo - Month 14|Placebo cohort with measurements at Baseline and Month 14.
278883|NCT00095238|O2|Outcome|Irbesartan - Month 6|Irbesartan cohort with measurements at Baseline and Month 6.
278884|NCT00095238|O1|Outcome|Placebo - Month 6|Placebo cohort with measurements at baseline and Month 6.
278885|NCT00095238|O2|Outcome|Irbesartan - Final Visit|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Final Visit
278886|NCT00095238|O1|Outcome|Placebo - Final Visit|Cohort of participants in Placebo group with MLwHF scores at Baseline and Final Visit
278887|NCT00095238|O4|Outcome|Irbesartan - Month 14|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Month 14
278888|NCT00095238|O3|Outcome|Placebo - Month 14|Cohort of participants in Placebo group with MLwHF scores at Baseline and Month 14
278889|NCT00095238|O2|Outcome|Irbesartan - Month 6|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Month 6
278890|NCT00095238|O1|Outcome|Placebo - Month 6|Cohort of participants in Placebo group with MLwHF scores at Baseline and Month 6
278891|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
278892|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
278893|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
278894|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
278895|NCT00095238|E2|Reported Event|PLACEBO|titration from 75 to 300 mg, once daily (QD), up to 6 years
278896|NCT00095238|E1|Reported Event|IRBESARTAN|titration from 75 to 300 mg, once daily (QD), up to 6 years
278897|NCT00095303|B3|Baseline|Total|Total of all reporting groups
278898|NCT00095303|B2|Baseline|TAU- Treatment as Usual|TAU: Treatment As Usual. Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
278899|NCT00095303|B1|Baseline|BSFT|BSFT: Brief Strategic Family Therapy. 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members
278900|NCT00095303|P2|Participant Flow|Treatment as Usual|Treatment as Usual : TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
278901|NCT00095303|P1|Participant Flow|BSFT|"Brief Strategic Family Therapy For Adolescent Drug Abusers : BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
278902|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278903|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278904|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278905|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278906|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278907|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278908|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278909|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278910|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278911|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278912|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
328415|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
278913|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278914|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278915|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278916|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278917|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278918|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278919|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278920|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278921|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278922|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278923|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278924|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278925|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278926|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278927|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278928|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278929|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278930|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278931|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278932|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278933|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278934|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278935|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278936|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278937|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278938|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278939|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278940|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278941|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278942|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278943|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278944|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278945|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278946|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278947|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278948|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278949|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278950|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278951|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278952|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278953|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278954|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278955|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278956|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278957|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278958|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278959|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278960|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278961|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278962|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual
Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT
Typically services include individual, group, and family therapy sessions as well as case management"
278963|NCT00095303|O1|Outcome|BSFT|"BSFT:
12-16 sessions, ranging from 8 to 24 as full dose
Sessions include adolescents and family members"
278964|NCT00095303|E2|Reported Event|Treatment as Usual|Treatment as Usual: TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
278965|NCT00095303|E1|Reported Event|BSFT|"Brief Strategic Family Therapy For Adolescent Drug Abusers: BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
278966|NCT00095498|B4|Baseline|Total|Total of all reporting groups
278967|NCT00095498|B3|Baseline|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
278968|NCT00095498|B2|Baseline|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278969|NCT00095498|B1|Baseline|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278970|NCT00095498|P3|Participant Flow|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
278971|NCT00095498|P2|Participant Flow|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278972|NCT00095498|P1|Participant Flow|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278973|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
278974|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278975|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278976|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
278977|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278978|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278979|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
278980|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278981|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278982|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
278983|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278984|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278985|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
278986|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278987|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278988|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
278989|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278990|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278991|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
278992|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278993|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278994|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
278995|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278996|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278997|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
278998|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
278999|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279000|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279001|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279002|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279003|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279004|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279005|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279006|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279007|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279008|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279009|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279010|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279011|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279012|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279013|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279014|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279015|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279016|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279017|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279018|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279019|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279020|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279021|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279022|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279023|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279024|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279025|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279026|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279027|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279028|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279029|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279030|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279031|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279032|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279033|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279034|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279035|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279036|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279037|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279038|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279039|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279040|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279041|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279042|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279043|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279044|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279045|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279046|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279047|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279048|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279049|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279050|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279051|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279052|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279053|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279054|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279055|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279056|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279057|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279058|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279059|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279060|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279061|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279062|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279063|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279064|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279065|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279066|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279067|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279068|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279069|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279070|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279071|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279072|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279073|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279074|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279075|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279076|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279077|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279078|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279079|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279080|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279081|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279082|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279083|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279084|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279085|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279086|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279087|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279088|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279089|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279090|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279091|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279092|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279093|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279094|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279095|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279096|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279097|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279098|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279099|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279100|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279101|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279102|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279103|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279104|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279105|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279106|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279107|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279108|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279109|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279110|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279111|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279112|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279113|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279114|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279115|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279116|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279117|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279118|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279119|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279120|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279121|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279122|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279123|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279124|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279125|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279126|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279127|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279128|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279129|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279130|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279131|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279132|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279133|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279134|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279135|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279136|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279137|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279138|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279139|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279140|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279141|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279142|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279143|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279144|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279145|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279146|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279147|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279148|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279149|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279150|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279151|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279152|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279153|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279154|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279155|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279156|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279157|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279158|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279159|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279160|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279161|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279162|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279163|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279164|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279165|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279166|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279167|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279168|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279169|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279170|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279171|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279172|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279173|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279174|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279175|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279176|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279177|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279178|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279179|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279180|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279181|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279182|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279183|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279184|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279185|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279186|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279187|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279188|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279189|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279190|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279191|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279192|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279193|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279194|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279195|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279196|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279197|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279198|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279199|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279200|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279201|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279202|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279203|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279204|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279205|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279206|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279207|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279208|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279209|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279210|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279211|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279212|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279213|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279214|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279215|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279216|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279217|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279218|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279219|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279220|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279221|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279222|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279223|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279224|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279225|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279226|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279227|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279228|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279229|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279230|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279231|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279232|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279233|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279234|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279235|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279236|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279237|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279238|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279239|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279240|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279241|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279242|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279243|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279244|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279245|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279246|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279247|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279248|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279249|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279250|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279251|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279252|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279253|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279254|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279255|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279256|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279257|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279258|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279259|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279260|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279261|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279262|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279263|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279264|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279265|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279266|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279267|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279268|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279269|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279270|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279271|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279272|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279273|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279274|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279275|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279276|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279277|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279278|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279279|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279280|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279281|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279282|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279283|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279284|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279285|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279286|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279287|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279288|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279289|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279290|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279291|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279292|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279293|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279294|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279295|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279296|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279297|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279298|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279299|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279300|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279301|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279302|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279303|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279304|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279305|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279306|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279307|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279308|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279309|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279310|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279311|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279312|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279313|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279314|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279315|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279316|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279317|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279318|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279319|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279320|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279321|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279322|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279323|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279324|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279325|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279326|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279327|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279328|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279329|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279330|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279331|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279332|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279333|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279334|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279335|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279336|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279337|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279338|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279339|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279340|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279341|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279342|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279343|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279344|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279345|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279346|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279347|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279348|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279349|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279350|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279351|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279352|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279353|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279354|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279355|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279356|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279357|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279358|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279359|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279360|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279361|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279362|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279363|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279364|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279365|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279366|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279367|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279368|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279369|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279370|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279371|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279372|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279373|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279374|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279375|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279376|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279377|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279378|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279379|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279380|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279381|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279382|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279383|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279384|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279385|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279386|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279387|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279388|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279389|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279390|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279391|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279392|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279393|NCT00095498|E3|Reported Event|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279394|NCT00095498|E2|Reported Event|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
279395|NCT00095498|E1|Reported Event|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
279396|NCT00095563|B1|Baseline|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies"
279397|NCT00095563|P1|Participant Flow|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies"
279398|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies"
279399|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies"
279400|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies"
279401|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies"
279402|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies"
279403|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies"
279404|NCT00095563|E1|Reported Event|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies"
279405|NCT00095576|B3|Baseline|Total|Total of all reporting groups
279406|NCT00095576|B2|Baseline|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
279407|NCT00095576|B1|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
279408|NCT00095576|P2|Participant Flow|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
279409|NCT00095576|P1|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
279410|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
279411|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
279412|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
279413|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
279414|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
279415|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
279416|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
279417|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
279418|NCT00095576|E2|Reported Event|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
279419|NCT00095576|E1|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
279420|NCT00095628|B1|Baseline|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
279421|NCT00095628|P1|Participant Flow|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
279422|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
279423|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
279424|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
279425|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
279426|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
279427|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
279428|NCT00095628|E1|Reported Event|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
279429|NCT00095784|B1|Baseline|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279430|NCT00095784|P1|Participant Flow|Decitabine|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279431|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279432|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279433|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279434|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279435|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279436|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279437|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279438|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279439|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279440|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279441|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279442|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279443|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279444|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279445|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279446|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279447|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279448|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279449|NCT00095784|O1|Outcome|Arm I|"Patients receive decitabine subcutaneously on days 1-5 and 8-12.
decitabine: Given SC"
279450|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279451|NCT00095784|E1|Reported Event|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.
decitabine : Given SC"
279452|NCT00095836|B1|Baseline|Gefitinib 250mg|Gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
279453|NCT00095836|P1|Participant Flow|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
279454|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
279455|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
279456|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
279457|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
279458|NCT00095836|E1|Reported Event|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
279459|NCT00095875|B3|Baseline|Total|Total of all reporting groups
279639|NCT00096278|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
279460|NCT00095875|B2|Baseline|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
cisplatin : Given IV
radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
279461|NCT00095875|B1|Baseline|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
cisplatin : Given IV
radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks
carboplatin : Given IV
fluorouracil : Given IV
docetaxel : Given IV"
279462|NCT00095875|P2|Participant Flow|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
cisplatin : Given IV
radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
279463|NCT00095875|P1|Participant Flow|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
cisplatin : Given IV
radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks
carboplatin : Given IV
fluorouracil : Given IV
docetaxel : Given IV"
279464|NCT00095875|O2|Outcome|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
cisplatin : Given IV
radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
279465|NCT00095875|O1|Outcome|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
cisplatin : Given IV
radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks
carboplatin : Given IV
fluorouracil : Given IV
docetaxel : Given IV"
279466|NCT00095875|O2|Outcome|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
cisplatin : Given IV
radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
279467|NCT00095875|O1|Outcome|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
cisplatin : Given IV
radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks
carboplatin : Given IV
fluorouracil : Given IV
docetaxel : Given IV"
279468|NCT00095875|E2|Reported Event|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
cisplatin : Given IV
radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
279469|NCT00095875|E1|Reported Event|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
cisplatin : Given IV
radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks
carboplatin : Given IV
fluorouracil : Given IV
docetaxel : Given IV"
279470|NCT00095940|B8|Baseline|Total|Total of all reporting groups
279471|NCT00095940|B7|Baseline|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
279472|NCT00095940|B6|Baseline|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
279473|NCT00095940|B5|Baseline|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
279474|NCT00095940|B4|Baseline|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
279475|NCT00095940|B3|Baseline|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
279502|NCT00095940|E5|Reported Event|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
279476|NCT00095940|B2|Baseline|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
279477|NCT00095940|B1|Baseline|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
279478|NCT00095940|P9|Participant Flow|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
279479|NCT00095940|P8|Participant Flow|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
279480|NCT00095940|P7|Participant Flow|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
279481|NCT00095940|P6|Participant Flow|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
279482|NCT00095940|P5|Participant Flow|High Grade Glioma: No Lapatinib Prior to Surgery|Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
279483|NCT00095940|P4|Participant Flow|High Grade Glioma: Lapatinib Prior to Surgery|Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
279484|NCT00095940|P3|Participant Flow|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
279485|NCT00095940|P2|Participant Flow|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
279486|NCT00095940|P1|Participant Flow|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
279487|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
279488|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
279489|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
279490|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
279491|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
279492|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
279493|NCT00095940|O1|Outcome|Lapatinib: No Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment
279494|NCT00095940|O1|Outcome|Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
279495|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
279496|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
279497|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
279498|NCT00095940|O2|Outcome|No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.
279499|NCT00095940|O1|Outcome|Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
279500|NCT00095940|E7|Reported Event|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment and were not eligible for the randomization to receive lapatinib or not prior to surgery.
279501|NCT00095940|E6|Reported Event|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.
279640|NCT00096356|B3|Baseline|Total|Total of all reporting groups
279503|NCT00095940|E4|Reported Event|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment.
279504|NCT00095940|E3|Reported Event|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment.
279505|NCT00095940|E2|Reported Event|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery.
279506|NCT00095940|E1|Reported Event|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
279507|NCT00095979|B1|Baseline|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
279508|NCT00095979|P1|Participant Flow|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
279509|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
279510|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
279511|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
279512|NCT00095979|E1|Reported Event|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
279513|NCT00096018|B3|Baseline|Total|Total of all reporting groups
279514|NCT00096018|B2|Baseline|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
279515|NCT00096018|B1|Baseline|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
279516|NCT00096018|P2|Participant Flow|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
279517|NCT00096018|P1|Participant Flow|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
279518|NCT00096018|O2|Outcome|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
279519|NCT00096018|O1|Outcome|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
279520|NCT00096018|O2|Outcome|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
279521|NCT00096018|O1|Outcome|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
279522|NCT00096018|E2|Reported Event|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
279523|NCT00096018|E1|Reported Event|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
279524|NCT00096031|B1|Baseline|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
279525|NCT00096031|P1|Participant Flow|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
279526|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
279527|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
279528|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
279529|NCT00096031|E1|Reported Event|Cetuximab|
279530|NCT00096044|B1|Baseline|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral"
279531|NCT00096044|P1|Participant Flow|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral"
279532|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral"
279533|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral"
279534|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral"
279535|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral"
279536|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral"
279537|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral"
279538|NCT00096044|E1|Reported Event|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral"
279641|NCT00096356|B2|Baseline|Arm 2 - Placebo & Vitamin E|Placebo plus Vitamin E 100mg/day in 3 doses
279539|NCT00096109|B1|Baseline|Treatment (Tanespimycin)|Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
279540|NCT00096109|P1|Participant Flow|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
279541|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
279542|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
279543|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
279544|NCT00096109|E1|Reported Event|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
tanespimycin: Given IV
laboratory biomarker analysis: Correlative studies"
279545|NCT00096122|B1|Baseline|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
279546|NCT00096122|P1|Participant Flow|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
279547|NCT00096122|O1|Outcome|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
279548|NCT00096122|E1|Reported Event|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
279549|NCT00096135|B3|Baseline|Total|Total of all reporting groups
279550|NCT00096135|B2|Baseline|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
279551|NCT00096135|B1|Baseline|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
279552|NCT00096135|P2|Participant Flow|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
279553|NCT00096135|P1|Participant Flow|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
279554|NCT00096135|O2|Outcome|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
279555|NCT00096135|O1|Outcome|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
279556|NCT00096135|E2|Reported Event|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
279557|NCT00096135|E1|Reported Event|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
279558|NCT00096161|B5|Baseline|Total|Total of all reporting groups
279609|NCT00096200|O2|Outcome|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
279559|NCT00096161|B4|Baseline|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279560|NCT00096161|B3|Baseline|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279561|NCT00096161|B2|Baseline|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279562|NCT00096161|B1|Baseline|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279563|NCT00096161|P4|Participant Flow|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279564|NCT00096161|P3|Participant Flow|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279565|NCT00096161|P2|Participant Flow|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279566|NCT00096161|P1|Participant Flow|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279567|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279568|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279569|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279570|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279571|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279572|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279573|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279574|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279610|NCT00096200|O1|Outcome|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 cycles of treatment may crossover to arm B.
279575|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279576|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279577|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279578|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279579|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279580|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279581|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279582|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279583|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279584|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279585|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279586|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279587|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279588|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279589|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279590|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279611|NCT00096200|E3|Reported Event|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
279638|NCT00096278|E2|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
279591|NCT00096161|E4|Reported Event|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279592|NCT00096161|E3|Reported Event|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279593|NCT00096161|E2|Reported Event|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279594|NCT00096161|E1|Reported Event|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV"
279595|NCT00096174|B1|Baseline|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
279596|NCT00096174|P1|Participant Flow|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
279597|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
279598|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
279599|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
279600|NCT00096174|E1|Reported Event|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
279601|NCT00096200|B4|Baseline|Total|Total of all reporting groups
279602|NCT00096200|B3|Baseline|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
279603|NCT00096200|B2|Baseline|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
279604|NCT00096200|B1|Baseline|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
279605|NCT00096200|P3|Participant Flow|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
279606|NCT00096200|P2|Participant Flow|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
279607|NCT00096200|P1|Participant Flow|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
279608|NCT00096200|O3|Outcome|Arm C: Crossover From Arm A to B|Cross-over arm: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
279637|NCT00096278|O1|Outcome|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
279612|NCT00096200|E2|Reported Event|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
279613|NCT00096200|E1|Reported Event|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
279614|NCT00096226|B1|Baseline|Chemoradiation, Surgery, Chemotherapy|"Chemoradiation, surgery, chemotherapy
carboplatin
paclitaxel
adjuvant therapy
conventional surgery
neoadjuvant therapy
radiation therapy"
279615|NCT00096226|P1|Participant Flow|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
279616|NCT00096226|O1|Outcome|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
279617|NCT00096226|E1|Reported Event|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
279618|NCT00096265|B4|Baseline|Total|Total of all reporting groups
279619|NCT00096265|B3|Baseline|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
279620|NCT00096265|B2|Baseline|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
279621|NCT00096265|B1|Baseline|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
279622|NCT00096265|P3|Participant Flow|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
279623|NCT00096265|P2|Participant Flow|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
279624|NCT00096265|P1|Participant Flow|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
279625|NCT00096265|O3|Outcome|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
279626|NCT00096265|O2|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
279627|NCT00096265|O1|Outcome|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
279628|NCT00096265|E3|Reported Event|Erlotinib+WBRT+SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months. [Data is reported for eligible patients with adverse event information, which is 41 patients.]
279629|NCT00096265|E2|Reported Event|Temozolomide+WBRT+SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. [Data is reported for eligible patients with adverse event information, which is 39 patients.]
279630|NCT00096265|E1|Reported Event|WBRT+SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery. [Data is reported for eligible patients with adverse event information, which is 44 patients.]
279631|NCT00096278|B3|Baseline|Total|Total of all reporting groups
279632|NCT00096278|B2|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
279633|NCT00096278|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
279634|NCT00096278|P2|Participant Flow|Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
279635|NCT00096278|P1|Participant Flow|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
279636|NCT00096278|O2|Outcome|Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
279642|NCT00096356|B1|Baseline|Arm 1 - CoQ10 & Vitamin E|CoQ10 plus Vitamin E 100mg/day in 3 doses
279643|NCT00096356|P2|Participant Flow|Arm 2 - Placebo + Vitamin E|Placebo + Vitamin E 100mg/day in 3 doses
279644|NCT00096356|P1|Participant Flow|Arm 1 - CoQ10 + Vitamin E|CoQ10 + Vitamin E 100mg/day in 3 doses
279645|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
279646|NCT00096356|O1|Outcome|Arm 1- CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
279647|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
279648|NCT00096356|O1|Outcome|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
279649|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
279650|NCT00096356|O1|Outcome|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
279651|NCT00096356|E2|Reported Event|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
279652|NCT00096356|E1|Reported Event|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
279653|NCT00096382|B3|Baseline|Total|Total of all reporting groups
279654|NCT00096382|B2|Baseline|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
279655|NCT00096382|B1|Baseline|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
279656|NCT00096382|P2|Participant Flow|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
279657|NCT00096382|P1|Participant Flow|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
279658|NCT00096382|O2|Outcome|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
279659|NCT00096382|O1|Outcome|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
279660|NCT00096382|O2|Outcome|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
279661|NCT00096382|O1|Outcome|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
279662|NCT00096382|E2|Reported Event|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
279663|NCT00096382|E1|Reported Event|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
279664|NCT00096447|B1|Baseline|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
279665|NCT00096447|P1|Participant Flow|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
279666|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
279667|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
279668|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
279669|NCT00096447|E1|Reported Event|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
279670|NCT00096460|B3|Baseline|Total|Total of all reporting groups
279671|NCT00096460|B2|Baseline|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
279672|NCT00096460|B1|Baseline|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
279673|NCT00096460|P2|Participant Flow|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
279674|NCT00096460|P1|Participant Flow|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
279675|NCT00096460|O2|Outcome|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
279730|NCT00096785|E2|Reported Event|ETV 0.5 mg|
279731|NCT00096785|E1|Reported Event|ADV 10 mg|
279676|NCT00096460|O1|Outcome|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
279677|NCT00096460|E2|Reported Event|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
279678|NCT00096460|E1|Reported Event|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
279679|NCT00096486|B5|Baseline|Total|Total of all reporting groups
279680|NCT00096486|B4|Baseline|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
279681|NCT00096486|B3|Baseline|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
279682|NCT00096486|B2|Baseline|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
279683|NCT00096486|B1|Baseline|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
279684|NCT00096486|P4|Participant Flow|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
279685|NCT00096486|P3|Participant Flow|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
279686|NCT00096486|P2|Participant Flow|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
279687|NCT00096486|P1|Participant Flow|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
279688|NCT00096486|O4|Outcome|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
279689|NCT00096486|O3|Outcome|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
279690|NCT00096486|O2|Outcome|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
279691|NCT00096486|O1|Outcome|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
279692|NCT00096486|E4|Reported Event|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
279693|NCT00096486|E3|Reported Event|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
279694|NCT00096486|E2|Reported Event|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
279695|NCT00096486|E1|Reported Event|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
279696|NCT00096538|B1|Baseline|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
279697|NCT00096538|P1|Participant Flow|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
279698|NCT00096538|O1|Outcome|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
279699|NCT00096538|E1|Reported Event|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
279700|NCT00096681|B1|Baseline|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
279701|NCT00096681|P1|Participant Flow|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
279702|NCT00096681|O1|Outcome|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
279703|NCT00096681|O1|Outcome|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
279704|NCT00096681|E1|Reported Event|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
279705|NCT00096785|B3|Baseline|Total|Total of all reporting groups
279706|NCT00096785|B2|Baseline|Adefovir|ADV 10 mg QD
279707|NCT00096785|B1|Baseline|Entecavir|ETV 0.5 mg once daily (QD)
279708|NCT00096785|P2|Participant Flow|Adefovir|ADV 10 mg QD
279709|NCT00096785|P1|Participant Flow|Entecavir|ETV 0.5 mg once daily (QD)
279710|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
279711|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
279712|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
279713|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
279714|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
279715|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
279716|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
279717|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
279718|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
279719|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
279720|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
279721|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
279722|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
279723|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
279724|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
279725|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
279726|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
279727|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
279728|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
279729|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
279732|NCT00096941|B1|Baseline|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.
Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
279733|NCT00096941|P1|Participant Flow|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.
Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
279734|NCT00096941|O1|Outcome|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.
Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
279735|NCT00096941|O1|Outcome|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.
Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
279736|NCT00096941|E1|Reported Event|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.
Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
279737|NCT00096954|B3|Baseline|Total|Total of all reporting groups
279738|NCT00096954|B2|Baseline|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
279739|NCT00096954|B1|Baseline|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
279740|NCT00096954|P2|Participant Flow|Placebo|The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.
279741|NCT00096954|P1|Participant Flow|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
279742|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
279743|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
279744|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
279745|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
279746|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
279747|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
279748|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
279749|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
279750|NCT00096954|E2|Reported Event|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
279751|NCT00096954|E1|Reported Event|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
279752|NCT00096993|B3|Baseline|Total|Total of all reporting groups
279753|NCT00096993|B2|Baseline|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles
Gemcitabine: Gemcitabine was provided as a solution for infusion.
Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
279754|NCT00096993|B1|Baseline|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).
Placebo: Placebo was provided as a single-use formulation for infusion.
Gemcitabine: Gemcitabine was provided as a solution for infusion."
279769|NCT00097253|B1|Baseline|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279755|NCT00096993|P2|Participant Flow|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles
Gemcitabine: Gemcitabine was provided as a solution for infusion.
Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
279756|NCT00096993|P1|Participant Flow|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).
Placebo: Placebo was provided as a single-use formulation for infusion.
Gemcitabine: Gemcitabine was provided as a solution for infusion."
279757|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles
Gemcitabine: Gemcitabine was provided as a solution for infusion.
Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
279758|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).
Placebo: Placebo was provided as a single-use formulation for infusion.
Gemcitabine: Gemcitabine was provided as a solution for infusion."
279759|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles
Gemcitabine: Gemcitabine was provided as a solution for infusion.
Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
279760|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).
Placebo: Placebo was provided as a single-use formulation for infusion.
Gemcitabine: Gemcitabine was provided as a solution for infusion."
279761|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles
Gemcitabine: Gemcitabine was provided as a solution for infusion.
Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
279762|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).
Placebo: Placebo was provided as a single-use formulation for infusion.
Gemcitabine: Gemcitabine was provided as a solution for infusion."
279763|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles
Gemcitabine: Gemcitabine was provided as a solution for infusion.
Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
279764|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).
Placebo: Placebo was provided as a single-use formulation for infusion.
Gemcitabine: Gemcitabine was provided as a solution for infusion."
279765|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles
Gemcitabine: Gemcitabine was provided as a solution for infusion.
Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
279766|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).
Placebo: Placebo was provided as a single-use formulation for infusion.
Gemcitabine: Gemcitabine was provided as a solution for infusion."
279767|NCT00096993|E2|Reported Event|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles
Gemcitabine: Gemcitabine was provided as a solution for infusion.
Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
279768|NCT00096993|E1|Reported Event|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).
Placebo: Placebo was provided as a single-use formulation for infusion.
Gemcitabine: Gemcitabine was provided as a solution for infusion."
279947|NCT00097721|B1|Baseline|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
279770|NCT00097253|P1|Participant Flow|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279771|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279772|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279773|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279774|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279775|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279776|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279777|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279778|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279779|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279780|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279781|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279782|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279783|NCT00097253|E1|Reported Event|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
279784|NCT00097370|B1|Baseline|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279785|NCT00097370|P1|Participant Flow|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by intravenous (IV) infusion monthly in Stage 1 along with concomitant hypereosinophilic syndrome (HES)-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279786|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279787|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279788|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279789|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279790|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
328416|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
279791|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279792|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279793|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279794|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279795|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279796|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279797|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279798|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279799|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279800|NCT00097370|E1|Reported Event|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
279801|NCT00097448|B3|Baseline|Total|Total of all reporting groups
279802|NCT00097448|B2|Baseline|Intratympanic Steroids|1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
279803|NCT00097448|B1|Baseline|Oral Steroids|Prednisone 60mg per day x 14 days, 5 day taper.
279804|NCT00097448|P2|Participant Flow|Intratympanic Steroids|1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
279805|NCT00097448|P1|Participant Flow|Oral Steroids|Prednisone 60mg per day x 14 days, 5 day taper.
279806|NCT00097448|O2|Outcome|IT Steroids|methylprednisolone
279807|NCT00097448|O1|Outcome|Oral Steroids|Prednisone
279808|NCT00097448|E2|Reported Event|IT Steroids|methylprednisolone
279809|NCT00097448|E1|Reported Event|Oral Steroids|Prednisone
279810|NCT00097500|B3|Baseline|Total|Total of all reporting groups
279811|NCT00097500|B2|Baseline|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279812|NCT00097500|B1|Baseline|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279813|NCT00097500|P2|Participant Flow|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279814|NCT00097500|P1|Participant Flow|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279815|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279816|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279817|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279818|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279819|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279820|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279821|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279822|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279823|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279824|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279825|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279826|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279827|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279828|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279829|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279830|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279831|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279832|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279833|NCT00097500|E2|Reported Event|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
279834|NCT00097500|E1|Reported Event|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
279835|NCT00097539|B8|Baseline|Total|Total of all reporting groups
279836|NCT00097539|B7|Baseline|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
279837|NCT00097539|B6|Baseline|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
279838|NCT00097539|B5|Baseline|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
279839|NCT00097539|B4|Baseline|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
279840|NCT00097539|B3|Baseline|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
279841|NCT00097539|B2|Baseline|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
279842|NCT00097539|B1|Baseline|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
279843|NCT00097539|P7|Participant Flow|Undefined Etiology|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
279859|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
279948|NCT00097721|P2|Participant Flow|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
279844|NCT00097539|P6|Participant Flow|Other Etiology|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. The other etiology group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
279845|NCT00097539|P5|Participant Flow|Renal Disease|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Renal etiology group included participants with chronic renal insufficiency (CRI) or End Stage Renal Disease (ESRD) prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
279846|NCT00097539|P4|Participant Flow|Turner Syndrome|Participants with Turner Syndrome who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
279847|NCT00097539|P3|Participant Flow|Idiopathic Short Stature (ISS)|Participants with ISS who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants must have had a stimulation result of greater than or equal to (>/=) 10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
279848|NCT00097539|P2|Participant Flow|Organic Growth Hormone Deficiency (GHD)|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Organic GHD etiology group included participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, central nervous system (CNS) tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
279849|NCT00097539|P1|Participant Flow|Idiopathic Growth Hormone Deficiency (IGHD)|Participants with IGDH who initiated therapy with Growth Hormone (GH) products (somatrem for injection [Protropin], somatropin for injection [Nutropin, Nutropin AQ, and Nutropin Depot]) and who consented to participate in the National Cooperative Growth Study (NCGS) were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. IGDH etiology group included participants with: Documented IGHD (a maximum GH stimulation test result of less than 10 nanograms per milliliter [ng/mL], coupled with a specific diagnosis of IGHD or equivalent condition by the attending physician; Undocumented IGHD (a stimulation test results were not available, but had a physician diagnosis specifically stated as IGHD or equivalent condition in text); or Presumed IGHD (a stimulation result of less than 10 ng/mL, coupled with the absence of any identifiable criterion for assignation to another etiology grouping).
279850|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
279851|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
279852|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
279853|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
279854|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
279855|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
279856|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
279857|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
279858|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
279944|NCT00097708|E1|Reported Event|OROS Alprazolam|
279860|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
279861|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
279862|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
279863|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
279864|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
279865|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
279866|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
279867|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
279868|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
279869|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
279870|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
279871|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
279872|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
279873|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
279874|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
279875|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
279876|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
279877|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
279878|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
279879|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
279880|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
279945|NCT00097721|B3|Baseline|Total|Total of all reporting groups
279881|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
279882|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
279883|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
279884|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
279885|NCT00097539|E7|Reported Event|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
279886|NCT00097539|E6|Reported Event|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
279887|NCT00097539|E5|Reported Event|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
279888|NCT00097539|E4|Reported Event|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
279889|NCT00097539|E3|Reported Event|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
279890|NCT00097539|E2|Reported Event|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
279891|NCT00097539|E1|Reported Event|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
279892|NCT00097591|B3|Baseline|Total|Total of all reporting groups
279893|NCT00097591|B2|Baseline|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
279894|NCT00097591|B1|Baseline|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
279895|NCT00097591|P2|Participant Flow|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
279896|NCT00097591|P1|Participant Flow|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
279897|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
279898|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
279899|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
279900|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
279901|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
279902|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
279903|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
279904|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
279946|NCT00097721|B2|Baseline|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
328417|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
279905|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
279906|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
279907|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
279908|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
279909|NCT00097591|E2|Reported Event|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
279910|NCT00097591|E1|Reported Event|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
279911|NCT00097695|B5|Baseline|Total|Total of all reporting groups
279912|NCT00097695|B4|Baseline|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
279913|NCT00097695|B3|Baseline|Controlled Open-label / Laryngeal Attack|patients who received first treatment Open-Label due to laryngeal symptoms
279914|NCT00097695|B2|Baseline|Randomized -Placebo|Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
279915|NCT00097695|B1|Baseline|Randomized -Icatibant|Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
279916|NCT00097695|P4|Participant Flow|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
279917|NCT00097695|P3|Participant Flow|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
279918|NCT00097695|P2|Participant Flow|Randomized -Placebo|Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
279919|NCT00097695|P1|Participant Flow|Randomized -Icatibant|Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
279920|NCT00097695|O2|Outcome|Randomized Control Trial-placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
279921|NCT00097695|O1|Outcome|Randomized Control Trial-icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
279922|NCT00097695|O2|Outcome|Randomized -Placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
279923|NCT00097695|O1|Outcome|Randomized -Icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
279924|NCT00097695|O2|Outcome|Randomized -Placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
279925|NCT00097695|O1|Outcome|Randomized -Icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
279926|NCT00097695|E6|Reported Event|Open Label Extension Phase(Untreated Patients at the Baseline)|This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
279927|NCT00097695|E5|Reported Event|Open Label Extension -Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase.
279928|NCT00097695|E4|Reported Event|Open Label Extension Phase- Icatibant (Previously Randomized)|Patients who were randomized to either icatibant or placebo in the controlled phase and experienced adverse events while participating in the open label extension phase.
279929|NCT00097695|E3|Reported Event|Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase.
279930|NCT00097695|E2|Reported Event|Controlled Phase- Placebo (Randomized Subjects|Patients who were randomized to placebo in the controlled phase and experienced adverse events while participating in the controlled phase.
279931|NCT00097695|E1|Reported Event|Controlled Phase- Icatibant (Randomized Subjects )|Patients who were randomized to icatibant in the controlled and experienced adverse events while participating in the controlled phase.
279932|NCT00097708|B4|Baseline|Total|Total of all reporting groups
279933|NCT00097708|B3|Baseline|Placebo|
279934|NCT00097708|B2|Baseline|IR Alprazolam|
279935|NCT00097708|B1|Baseline|OROS Alprazolam|
279936|NCT00097708|P3|Participant Flow|Placebo|OROS (osmotic [controlled] release oral [delivery] system) placebo administered orally once a day.
279937|NCT00097708|P2|Participant Flow|IR Alprazolam|IR (immediate release) alprazolam (Xanax) administered orally in divided dose (3 times daily), titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
279938|NCT00097708|P1|Participant Flow|OROS Alprazolam|OROS (osmotic [controlled] release oral [delivery] system) alprazolam administered orally once a day, titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
279939|NCT00097708|O3|Outcome|Placebo|
279940|NCT00097708|O2|Outcome|IR Alprazolam|
279941|NCT00097708|O1|Outcome|OROS Alprazolam|
279942|NCT00097708|E3|Reported Event|Placebo|
279943|NCT00097708|E2|Reported Event|IR Alprazolam|
279949|NCT00097721|P1|Participant Flow|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
279950|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
279951|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
279952|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
279953|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
279954|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
279955|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
279956|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
279957|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
279958|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
279959|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
279960|NCT00097721|E2|Reported Event|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
279961|NCT00097721|E1|Reported Event|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
279962|NCT00088374|B1|Baseline|VHL Associated Renal Tumors|17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.
279963|NCT00088374|P1|Participant Flow|VHL Associated Renal Tumors|17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.
279964|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
279965|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
279966|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
279967|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
279968|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
279969|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
279970|NCT00088374|E1|Reported Event|Participants With VHL Associated Renal Tumors|
279971|NCT00088465|B1|Baseline|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279972|NCT00088465|P1|Participant Flow|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279973|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279974|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279975|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279976|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279977|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279978|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279979|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279980|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279981|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279982|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279983|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279984|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279985|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279986|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279987|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279988|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279989|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279990|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279991|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279992|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279993|NCT00088465|E1|Reported Event|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
279994|NCT00088530|B3|Baseline|Total|Total of all reporting groups
279995|NCT00088530|B2|Baseline|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
279996|NCT00088530|B1|Baseline|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
279997|NCT00088530|P2|Participant Flow|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
279998|NCT00088530|P1|Participant Flow|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle)
279999|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
328418|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
280000|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
280001|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
280002|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
280003|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
280004|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
280005|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
280006|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
280007|NCT00088530|E2|Reported Event|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
280008|NCT00088530|E1|Reported Event|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
280009|NCT00088595|B1|Baseline|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
280010|NCT00088595|P1|Participant Flow|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
280011|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
280012|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
280013|NCT00088595|O4|Outcome|Pasireotide Any Dose|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
280014|NCT00088595|O3|Outcome|Pasireotide >1500-≤2400 μg|SOM230 (Pasireotide), more than 750µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
280015|NCT00088595|O2|Outcome|Pasireotide >900-≤1500 μg|SOM230 (Pasireotide), more than 450µg twice daily dose titration up to 750µg twice daily, subcutaneous injection.
280016|NCT00088595|O1|Outcome|Pasireotide 300-≤900 μg|SOM230 (Pasireotide), 150µg twice daily dose titration up to 450µg twice daily, subcutaneous injection.
280017|NCT00088595|O4|Outcome|Pasireotide Any Dose|SOM230 (Pasireotide), 300 ug - 2400 ug / day
280018|NCT00088595|O3|Outcome|Pasireotide >1500 - ≤2400 μg|SOM230 (Pasireotide), >1500 - ≤2400 μg / day
280019|NCT00088595|O2|Outcome|Pasireotide >900 - ≤1500 μg|SOM230 (Pasireotide), >900 - ≤1500 μg / day
280020|NCT00088595|O1|Outcome|Pasireotide 300 - ≤900 μg|SOM230 (Pasireotide), 300 - ≤900 μg / day
280021|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
280022|NCT00088595|E3|Reported Event|Pasireotide > 1500 ≤ 2400 μg|Pasireotide > 1500 ≤ 2400 μg / day
280023|NCT00088595|E2|Reported Event|Pasireotide > 900 ≤ 1500 μg|Pasireotide > 900 ≤ 1500 μg / day
280024|NCT00088595|E1|Reported Event|Pasireotide 300 ≤ 900 μg|Pasireotide 300 ≤ 900 μg / day
280025|NCT00088621|B1|Baseline|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
280026|NCT00088621|P1|Participant Flow|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the participant flow is based on the number of subjects that entered the extension study which is 61 subjects.
280027|NCT00088621|O1|Outcome|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
280028|NCT00088621|E1|Reported Event|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
280029|NCT00088634|B3|Baseline|Total|Total of all reporting groups
280030|NCT00088634|B2|Baseline|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
280031|NCT00088634|B1|Baseline|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
280032|NCT00088634|P2|Participant Flow|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
280033|NCT00088634|P1|Participant Flow|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
280034|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
280035|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
280036|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
280037|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
280038|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
280039|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
280040|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
280041|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
280042|NCT00088634|E2|Reported Event|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
280043|NCT00088634|E1|Reported Event|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
280055|NCT00088907|B1|Baseline|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
placebo: Given orally"
280104|NCT00089076|B1|Baseline|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
328419|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
280044|NCT00088881|B1|Baseline|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
280045|NCT00088881|P1|Participant Flow|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
280046|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
280047|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
280048|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
280049|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
280050|NCT00088881|E3|Reported Event|Step 3 - Radiation Therapy|Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
280051|NCT00088881|E2|Reported Event|Step 2 - Zevalin™ Radioimmunotherapy|Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
280052|NCT00088881|E1|Reported Event|Step 1 - R-CHOP|Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
280053|NCT00088907|B3|Baseline|Total|Total of all reporting groups
280054|NCT00088907|B2|Baseline|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
280418|NCT00089674|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280056|NCT00088907|P2|Participant Flow|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
280057|NCT00088907|P1|Participant Flow|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
placebo: Given orally"
280058|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
280059|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
placebo: Given orally"
280060|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
280061|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
placebo: Given orally"
280062|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
280063|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
placebo: Given orally"
280064|NCT00088907|E3|Reported Event|Step 2: ZD1839|ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle.
280065|NCT00088907|E2|Reported Event|Step 1: Docetaxel+ZD1839|"Premedication: Dexamethasone
Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8, and 15 of a 28-day schedule.
ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle."
280066|NCT00088907|E1|Reported Event|Step 1: Docetaxel+Placebo|"Premedication: Dexamethasone
Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8,and 15 of a 28-day schedule
Placebo one tablet daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle."
280067|NCT00088972|B3|Baseline|Total|Total of all reporting groups
280068|NCT00088972|B2|Baseline|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
280069|NCT00088972|B1|Baseline|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
280070|NCT00088972|P2|Participant Flow|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
280071|NCT00088972|P1|Participant Flow|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
280072|NCT00088972|O2|Outcome|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
280073|NCT00088972|O1|Outcome|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
280074|NCT00088972|E2|Reported Event|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
280075|NCT00088972|E1|Reported Event|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
280076|NCT00088985|B1|Baseline|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab: 4 mg/kg intravenously, every 14 days
vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
280103|NCT00089011|E1|Reported Event|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies"
280419|NCT00089674|B1|Baseline|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280077|NCT00088985|P1|Participant Flow|Dendritic Cell Vaccine|"Dendritic Cells (DCs): Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250 μg/m2 sc each day for four days. G-CSF and/or GM-CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab: 4 mg/kg intravenously, every 14 days
vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
280078|NCT00088985|O1|Outcome|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab: 4 mg/kg intravenously, every 14 days
vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
280079|NCT00088985|O1|Outcome|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab: 4 mg/kg intravenously, every 14 days
vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
280080|NCT00088985|E1|Reported Event|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab: 4 mg/kg intravenously, every 14 days
vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
280081|NCT00089011|B3|Baseline|Total|Total of all reporting groups
280082|NCT00089011|B2|Baseline|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies"
280083|NCT00089011|B1|Baseline|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies"
280084|NCT00089011|P2|Participant Flow|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies"
280085|NCT00089011|P1|Participant Flow|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies"
280086|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies"
280087|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies"
280088|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies"
280089|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies"
280090|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies"
280091|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies"
280092|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies"
280093|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies"
280094|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies"
280095|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies"
280096|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies"
280097|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies"
280098|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies"
280099|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies"
280100|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies"
280101|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies"
280102|NCT00089011|E2|Reported Event|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies"
280423|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280105|NCT00089076|P1|Participant Flow|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
280106|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
280107|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
280108|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
280109|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
280110|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
280111|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
280112|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
280113|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
280114|NCT00089076|E1|Reported Event|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
280115|NCT00089141|B3|Baseline|Total|Total of all reporting groups
280116|NCT00089141|B2|Baseline|Placebo|Patients receive oral placebo twice daily
280117|NCT00089141|B1|Baseline|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280118|NCT00089141|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily
280119|NCT00089141|P1|Participant Flow|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280120|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
280121|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280122|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
280123|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280124|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
280125|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280126|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
280127|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280128|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
280129|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280130|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
280131|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280132|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
280133|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280134|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
280135|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280136|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
280137|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280138|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
280139|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
280140|NCT00089297|B1|Baseline|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
280151|NCT00089414|P3|Participant Flow|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
280141|NCT00089297|P1|Participant Flow|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
280142|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
280143|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
280144|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
280145|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
280146|NCT00089297|E1|Reported Event|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
280147|NCT00089414|B4|Baseline|Total|Total of all reporting groups
280148|NCT00089414|B3|Baseline|Continuous OC Plus PR Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
280149|NCT00089414|B2|Baseline|Interrupted OC|Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo).
280150|NCT00089414|B1|Baseline|Continuous OCP Plus Placebo|Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
280420|NCT00089674|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280152|NCT00089414|P2|Participant Flow|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
280153|NCT00089414|P1|Participant Flow|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
280154|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
280155|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
280156|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
280157|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
280158|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
280159|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
280160|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
280161|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
280162|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
280163|NCT00089414|E3|Reported Event|Continuous OC Plus PR Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
280164|NCT00089414|E2|Reported Event|Interrupted OC|Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo).
280165|NCT00089414|E1|Reported Event|Continuous OCP Plus Placebo|Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
280166|NCT00089479|B3|Baseline|Total|Total of all reporting groups
280167|NCT00089479|B2|Baseline|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280168|NCT00089479|B1|Baseline|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280169|NCT00089479|P2|Participant Flow|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280170|NCT00089479|P1|Participant Flow|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280171|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280172|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280173|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280174|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280175|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280176|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280177|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280178|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280179|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280180|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280181|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280182|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280183|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280184|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280185|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280186|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280187|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280188|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280189|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280190|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280191|NCT00089479|E2|Reported Event|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
280192|NCT00089479|E1|Reported Event|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
280193|NCT00089505|B5|Baseline|Total|Total of all reporting groups
280194|NCT00089505|B4|Baseline|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280195|NCT00089505|B3|Baseline|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280196|NCT00089505|B2|Baseline|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280211|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280197|NCT00089505|B1|Baseline|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280198|NCT00089505|P4|Participant Flow|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280199|NCT00089505|P3|Participant Flow|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280200|NCT00089505|P2|Participant Flow|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280201|NCT00089505|P1|Participant Flow|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280202|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280203|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280204|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280205|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280206|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280207|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280208|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280209|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280210|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280948|NCT00101036|P1|Participant Flow|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
280212|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280213|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280214|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280215|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280216|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280217|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280218|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280219|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280220|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280221|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280222|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280223|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280224|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280225|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280226|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280227|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280228|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280229|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280230|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280231|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280232|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280233|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280234|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280235|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280236|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280237|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280238|NCT00089505|E4|Reported Event|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
280239|NCT00089505|E3|Reported Event|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
280271|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
280949|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
280240|NCT00089505|E2|Reported Event|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
280241|NCT00089505|E1|Reported Event|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
280242|NCT00089544|B3|Baseline|Total|Total of all reporting groups
280243|NCT00089544|B2|Baseline|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
280244|NCT00089544|B1|Baseline|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
280245|NCT00089544|P2|Participant Flow|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
280246|NCT00089544|P1|Participant Flow|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
280247|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
280248|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
280249|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
280250|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
280251|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
280252|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
280253|NCT00089544|E2|Reported Event|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
280272|NCT00089583|O4|Outcome|PI Experienced, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
280421|NCT00089674|P1|Participant Flow|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280254|NCT00089544|E1|Reported Event|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
280255|NCT00089583|B3|Baseline|Total|Total of all reporting groups
280256|NCT00089583|B2|Baseline|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280257|NCT00089583|B1|Baseline|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280258|NCT00089583|P2|Participant Flow|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280259|NCT00089583|P1|Participant Flow|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280260|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280261|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280262|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280263|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280264|NCT00089583|O4|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
280265|NCT00089583|O3|Outcome|PI Naïve, ART-experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
280266|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
280267|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
280268|NCT00089583|O4|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
280269|NCT00089583|O3|Outcome|PI Naïve, ART-experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
280270|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
328420|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
280273|NCT00089583|O3|Outcome|PI Naïve, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
280274|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
280275|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
280276|NCT00089583|O4|Outcome|PI Experienced, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
280277|NCT00089583|O3|Outcome|PI Naïve, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
280278|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
280279|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
280280|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280281|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280282|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280283|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280284|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280285|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280286|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280287|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280299|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280422|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
328421|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
280288|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280289|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280290|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280291|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280292|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280293|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280294|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280295|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280296|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280297|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280298|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280366|NCT00089609|O1|Outcome|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
328422|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
280300|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280301|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280302|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280303|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280304|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280305|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280306|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280307|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280308|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280309|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280310|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280367|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280311|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280312|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280313|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280314|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280315|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280316|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280317|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280318|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280319|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280320|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280321|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280333|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280409|NCT00089661|O2|Outcome|Placebo|
280410|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
280411|NCT00089661|O2|Outcome|Placebo|
280322|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280323|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280324|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280325|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280326|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280327|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280328|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280329|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280330|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280331|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280332|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280364|NCT00089609|O2|Outcome|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
280412|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
280334|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280335|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280336|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280337|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280338|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280339|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280340|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280341|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280342|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280343|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280344|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280365|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280413|NCT00089661|O2|Outcome|Placebo|
280345|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280346|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280347|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280348|NCT00089583|E2|Reported Event|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
280349|NCT00089583|E1|Reported Event|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
280350|NCT00089609|B3|Baseline|Total|Total of all reporting groups
280351|NCT00089609|B2|Baseline|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
280352|NCT00089609|B1|Baseline|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280353|NCT00089609|P2|Participant Flow|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
280354|NCT00089609|P1|Participant Flow|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280355|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280356|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280357|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280358|NCT00089609|O2|Outcome|Main Cohort - Particpants With <75% PSA Decline|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280359|NCT00089609|O1|Outcome|Main Cohort - Particpants With ≥75% PSA Decline|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280360|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280361|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280362|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280363|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280414|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
280368|NCT00089609|E2|Reported Event|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
280369|NCT00089609|E1|Reported Event|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
280370|NCT00089635|B1|Baseline|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280371|NCT00089635|P1|Participant Flow|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280372|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280373|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280374|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280375|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280376|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280377|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280378|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280379|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280380|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280381|NCT00089635|E1|Reported Event|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
280382|NCT00089648|B1|Baseline|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280383|NCT00089648|P1|Participant Flow|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280384|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280385|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280386|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280387|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280388|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280389|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280390|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280391|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280392|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280393|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280394|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280395|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280396|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280397|NCT00089648|E1|Reported Event|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
280398|NCT00089661|B3|Baseline|Total|Total of all reporting groups
280399|NCT00089661|B2|Baseline|Placebo|
280400|NCT00089661|B1|Baseline|Denosumab 60 mg Q6M|
280401|NCT00089661|P2|Participant Flow|Placebo|
280402|NCT00089661|P1|Participant Flow|Denosumab 60 mg Q6M|
280403|NCT00089661|O2|Outcome|Placebo|
280404|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
280405|NCT00089661|O2|Outcome|Placebo|
280406|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
280407|NCT00089661|O2|Outcome|Placebo|
280408|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
280424|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280425|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280426|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280427|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280428|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280429|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280430|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280431|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280432|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280433|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280434|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280435|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280436|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280437|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280438|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280439|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280440|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280441|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280442|NCT00089674|E2|Reported Event|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
280443|NCT00089674|E1|Reported Event|Placebo|Placebo administered subcutaneous every 6 months for 3 years
280444|NCT00089752|B3|Baseline|Total|Total of all reporting groups
280445|NCT00089752|B2|Baseline|Sham CPAP|Sham CPAP device
280446|NCT00089752|B1|Baseline|Active CPAP|CPAP device
280447|NCT00089752|P2|Participant Flow|Sham CPAP|A device that looks and sounds like an active continuous positive pressure device (CPAP) that delivers ineffective pressure, i.e.,less than 1 cm H20 pressure compared to greater than 5 cm H20 for active treatment. Like active CPAP treatment it is worn every night.
280448|NCT00089752|P1|Participant Flow|Active CPAP|Continuous positive pressure device that delivers therapeutic positive airway pressure to maintain airway patency worn continuously for each night of treatment.
280449|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
280450|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
280451|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
280452|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
280453|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
280454|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
280455|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
280456|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
280457|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
280458|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
280459|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
280460|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
280461|NCT00089752|O2|Outcome|Sham CPAP|Sham CPAP device
280462|NCT00089752|O1|Outcome|Active CPAP|continuous positive airway pressure device
280463|NCT00089752|E2|Reported Event|Sham CPAP|A device worn continuously every night that looks and sounds like an active continuous positive pressure device (CPAP) that delivers ineffective pressure, i.e.,less than 1 cm H20 pressure for 8 wks.
280464|NCT00089752|E1|Reported Event|Active CPAP|Continuous positive pressure device that delivers therapeutic (prescribed > 5 CM H2O) positive airway pressure worn continuously for each night of treatment for 8 wks.
280465|NCT00089778|B4|Baseline|Total|Total of all reporting groups
280466|NCT00089778|B3|Baseline|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
280467|NCT00089778|B2|Baseline|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
280468|NCT00089778|B1|Baseline|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
280469|NCT00089778|P3|Participant Flow|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant).
This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
328423|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
280470|NCT00089778|P2|Participant Flow|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).
This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
280471|NCT00089778|P1|Participant Flow|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.
This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
280472|NCT00089778|O1|Outcome|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
280473|NCT00089778|O3|Outcome|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
280474|NCT00089778|O2|Outcome|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
280475|NCT00089778|O1|Outcome|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
280476|NCT00089778|O2|Outcome|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
280477|NCT00089778|O1|Outcome|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.
Because patients in Group C had no evaluable disease, response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B)."
280478|NCT00089778|E3|Reported Event|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.
A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
280479|NCT00089778|E2|Reported Event|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
280480|NCT00089778|E1|Reported Event|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.
A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
280481|NCT00089791|B3|Baseline|Total|Total of all reporting groups
280482|NCT00089791|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
280483|NCT00089791|B1|Baseline|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
280484|NCT00089791|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
280485|NCT00089791|P1|Participant Flow|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
280486|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
280487|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
280488|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
280489|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
280490|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
280491|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
280492|NCT00089791|E2|Reported Event|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
280493|NCT00089791|E1|Reported Event|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
280494|NCT00089843|B5|Baseline|Total|Total of all reporting groups
280495|NCT00089843|B4|Baseline|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
280496|NCT00089843|B3|Baseline|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
280497|NCT00089843|B2|Baseline|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
280498|NCT00089843|B1|Baseline|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
280499|NCT00089843|P4|Participant Flow|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
280500|NCT00089843|P3|Participant Flow|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
280501|NCT00089843|P2|Participant Flow|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
280502|NCT00089843|P1|Participant Flow|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
280503|NCT00089843|O2|Outcome|Testosterone|Testosterone patch(starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
280504|NCT00089843|O1|Outcome|Actonel (Risedronate)|Actonel (risedronate) 35 mg tablet weekly
280505|NCT00089843|O2|Outcome|Testosterone|Testosterone, initial dose 150 mcg transdermal daily, increased to 300 mcg daily in women with free testosterone levels below the median (n=25 women)
280506|NCT00089843|O1|Outcome|Actonel (Risedronate) 35 mg Weekly|Actonel (risedronate) 35 mg, 1 tablet weekly
280507|NCT00089843|E4|Reported Event|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
280508|NCT00089843|E3|Reported Event|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
280509|NCT00089843|E2|Reported Event|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
280510|NCT00089843|E1|Reported Event|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
280511|NCT00089895|B3|Baseline|Total|Total of all reporting groups
280512|NCT00089895|B2|Baseline|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
280513|NCT00089895|B1|Baseline|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
280514|NCT00089895|P2|Participant Flow|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
280515|NCT00089895|P1|Participant Flow|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
280516|NCT00089895|O2|Outcome|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
280517|NCT00089895|O1|Outcome|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
280518|NCT00089895|O2|Outcome|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
280519|NCT00089895|O1|Outcome|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
280520|NCT00089895|E2|Reported Event|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
280521|NCT00089895|E1|Reported Event|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
280522|NCT00089986|B4|Baseline|Total|Total of all reporting groups
280523|NCT00089986|B3|Baseline|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
280524|NCT00089986|B2|Baseline|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
280525|NCT00089986|B1|Baseline|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
280556|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
328424|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
280526|NCT00089986|P3|Participant Flow|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
280527|NCT00089986|P2|Participant Flow|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 milligrams per milliliter (mg/mL) lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 milligram (mg)/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
280528|NCT00089986|P1|Participant Flow|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, intravenously (IV) as a loading dose infused over 2 hours (h) followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 milliliters per kilogram per hour (mL/kg/h) for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
280529|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
280530|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
280531|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
280532|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
280533|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
280534|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
280535|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
280536|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
280537|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
280538|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
280633|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
328425|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
280539|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
280540|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
280541|NCT00089986|E3|Reported Event|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
280542|NCT00089986|E2|Reported Event|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
280543|NCT00089986|E1|Reported Event|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
280544|NCT00089999|B3|Baseline|Total|Total of all reporting groups
280545|NCT00089999|B2|Baseline|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280546|NCT00089999|B1|Baseline|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280547|NCT00089999|P2|Participant Flow|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally twice daily (BID). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280548|NCT00089999|P1|Participant Flow|Lapatinib 1500 mg QD|Participants received lapatinib 1500 milligram (mg) orally once daily (QD). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280549|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280550|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280551|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280552|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280553|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280554|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280555|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280557|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280558|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280559|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280560|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280561|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280562|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280563|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280564|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280565|NCT00089999|E2|Reported Event|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280566|NCT00089999|E1|Reported Event|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
280567|NCT00090051|B3|Baseline|Total|Total of all reporting groups
280568|NCT00090051|B2|Baseline|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280569|NCT00090051|B1|Baseline|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280570|NCT00090051|P2|Participant Flow|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280571|NCT00090051|P1|Participant Flow|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280572|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280573|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280574|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280634|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280950|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
280575|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280576|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280577|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280578|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280579|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280580|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280581|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280582|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280583|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280584|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280585|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280586|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280587|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280588|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280589|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280590|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280591|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280592|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280593|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280594|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280635|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
328426|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
280595|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280596|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280597|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280598|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280599|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280600|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280601|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280602|NCT00090051|E2|Reported Event|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
280603|NCT00090051|E1|Reported Event|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
280604|NCT00090103|B4|Baseline|Total|Total of all reporting groups
280605|NCT00090103|B3|Baseline|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280606|NCT00090103|B2|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280607|NCT00090103|B1|Baseline|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280608|NCT00090103|P3|Participant Flow|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280609|NCT00090103|P2|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280610|NCT00090103|P1|Participant Flow|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280611|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280612|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280613|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280614|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280615|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280616|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280617|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280618|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280619|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280620|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280621|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280622|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280623|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280624|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280625|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280626|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280627|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280628|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280629|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280630|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280631|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280632|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
328427|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
280636|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280637|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280638|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280639|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280640|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280641|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280642|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280643|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280644|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280645|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280646|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280647|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280648|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280649|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280650|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280651|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280652|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280653|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280654|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280655|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280656|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280657|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280658|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280659|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280660|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280661|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280662|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280663|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280664|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280665|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280666|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280667|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280668|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280669|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280670|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280671|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280672|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280673|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280674|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280675|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280676|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280677|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280678|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280679|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280680|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280681|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280682|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280683|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280684|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280685|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280686|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280687|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280688|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280689|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280690|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280691|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280692|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280693|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280694|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280695|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280696|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280697|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280698|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280699|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280700|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280701|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
280702|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
280703|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
280704|NCT00090103|E3|Reported Event|Tamsulosin 0.4 mg|
280705|NCT00090103|E2|Reported Event|Dutasteride 0.5 mg|
280706|NCT00090103|E1|Reported Event|Combination|
280707|NCT00090142|B1|Baseline|Overall Study Population|All randomized patients
280708|NCT00090142|P2|Participant Flow|Placebo in Period I Then Montelukast 10 mg in Period II|"A montelukast matching-image placebo tablet (Treatment Period I) was taken
orally in the morning as a single witnessed dose. This was followed by a 3-7 day washout and then a
montelukast 10-mg tablet (Treatment Period II) was taken orally in the morning as a single witnessed dose."
280709|NCT00090142|P1|Participant Flow|Montelukast 10 mg in Period I Then Placebo in Period II|"A montelukast 10-mg tablet (Treatment Period I) was taken orally in the
morning as a single witnessed dose. This was followed by a 3-7 day washout period and then a montelukast
matching-image placebo tablet (Treatment Period II) was taken orally in the morning as a single witnessed
dose."
280710|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280711|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280712|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280713|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280714|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280715|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280716|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280717|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280718|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280719|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280720|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280721|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280722|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280723|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280724|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280725|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280726|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280727|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280728|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280729|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280730|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280731|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280732|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
280733|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
280734|NCT00090142|E2|Reported Event|Placebo|
280735|NCT00090142|E1|Reported Event|Montelukast 10 mg|
280736|NCT00097773|B5|Baseline|Total|Total of all reporting groups
280737|NCT00097773|B4|Baseline|Culture-Based TIS w/Cipro|TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
280738|NCT00097773|B3|Baseline|Culture-Based TIS w/Placebo|TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
280739|NCT00097773|B2|Baseline|Cycled TIS w/Cipro|TOBI and oral ciprofloxacin for six consecutive quarterly cycles
280740|NCT00097773|B1|Baseline|Cycled TIS w/Placebo|TOBI and oral placebo for six consecutive quarterly cycles
280781|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
280741|NCT00097773|P4|Participant Flow|Culture-Based TOBI and Oral Placebo|Tobramycin solution for inhalation (TOBI) and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
280742|NCT00097773|P3|Participant Flow|Culture-Based TOBI and Oral Ciprofloxacin|Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
280743|NCT00097773|P2|Participant Flow|Cycled TOBI and Oral Ciprofloxacin|Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin for six consecutive quarterly cycles
280744|NCT00097773|P1|Participant Flow|Cycled TOBI and Oral Placebo|Tobramycin solution for inhalation (TOBI) and oral placebo for six consecutive quarterly cycles
280745|NCT00097773|O4|Outcome|Oral Placebo|Pooled oral placebo group
280746|NCT00097773|O3|Outcome|Oral Ciprofloxacin|Pooled oral cipro group
280747|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS therapy group
280748|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled TIS therapy group
280749|NCT00097773|O4|Outcome|Oral Placebo|pooled oral placebo group
280750|NCT00097773|O3|Outcome|Oral Cipro|Pooled oral cipro group
280751|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS group
280752|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled TIS group
280753|NCT00097773|O4|Outcome|Oral Placebo|Pooled oral placebo group
280754|NCT00097773|O3|Outcome|Oral Ciprofloxacin|Pooled oral cipro group
280755|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS therapy group
280756|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled tobramycin solution for inhalation (TIS) therapy group
280757|NCT00097773|E4|Reported Event|Culture-Based TIS w/Cipro|TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for PA
280758|NCT00097773|E3|Reported Event|Culture-Based TIS w/Placebo|TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (PA)
280759|NCT00097773|E2|Reported Event|Cycled TIS w/Cipro|TOBI and oral ciprofloxacin for six consecutive quarterly cycles
280760|NCT00097773|E1|Reported Event|Cycled TIS w/Placebo|TOBI and oral placebo for six consecutive quarterly cycles
280761|NCT00097786|B5|Baseline|Total|Total of all reporting groups
280762|NCT00097786|B4|Baseline|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
280763|NCT00097786|B3|Baseline|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
280764|NCT00097786|B2|Baseline|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
280765|NCT00097786|B1|Baseline|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
280766|NCT00097786|P4|Participant Flow|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
280767|NCT00097786|P3|Participant Flow|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
280768|NCT00097786|P2|Participant Flow|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
280769|NCT00097786|P1|Participant Flow|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
280770|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
280771|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
280772|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
280773|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
280774|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
280775|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
280776|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
280777|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
280778|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
280779|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
280780|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
280782|NCT00097786|E4|Reported Event|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
280783|NCT00097786|E3|Reported Event|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
280784|NCT00097786|E2|Reported Event|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
280785|NCT00097786|E1|Reported Event|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
280786|NCT00097981|B3|Baseline|Total|Total of all reporting groups
280787|NCT00097981|B2|Baseline|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280788|NCT00097981|B1|Baseline|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280789|NCT00097981|P2|Participant Flow|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280790|NCT00097981|P1|Participant Flow|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280791|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280792|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280793|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280794|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280795|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280796|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280797|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280798|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280847|NCT00098059|O1|Outcome|1 to < 2 Years|
280848|NCT00098059|O4|Outcome|13 to <=18 Years|
280849|NCT00098059|O3|Outcome|6 to <13 Years|
280850|NCT00098059|O2|Outcome|2 to <6 Years|
280851|NCT00098059|O1|Outcome|1 to < 2 Years|
280799|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280800|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280801|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280802|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280803|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280804|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280805|NCT00097981|E2|Reported Event|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280806|NCT00097981|E1|Reported Event|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
280807|NCT00098059|B3|Baseline|Total|Total of all reporting groups
280808|NCT00098059|B2|Baseline|Part B (Multiple-dose of Famciclovir)|Each patient in Part B received famciclovir twice a day (b.i.d.) approximately 12 hours apart for 7 days for a total of 14 doses. An 8-step dosing scheme (ranged from 150 mg b.i.d. to 500 mg b.i.d.) was used to determine the weight-based adjusted daily dose.
280809|NCT00098059|B1|Baseline|Part A (Single-dose of Famciclovir)|Each patient in Part A received a single dose of famciclovir (12.5 mg/kg).
280810|NCT00098059|P2|Participant Flow|Part B (Multiple-dose of Famciclovir)|Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
280811|NCT00098059|P1|Participant Flow|Part A (Single-dose of Famciclovir)|Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
280812|NCT00098059|O4|Outcome|13 to <=18 Years|
280813|NCT00098059|O3|Outcome|6 to <13 Years|
280814|NCT00098059|O2|Outcome|2 to <6 Years|
280815|NCT00098059|O1|Outcome|1 to < 2 Years|
280816|NCT00098059|O4|Outcome|13 to <= 18 Years|
280817|NCT00098059|O3|Outcome|6 to <=12 Years|
280818|NCT00098059|O2|Outcome|2 to <6 Years|
280819|NCT00098059|O1|Outcome|1 to < 2 Years|
280820|NCT00098059|O4|Outcome|13 to <= 18 Years|
280821|NCT00098059|O3|Outcome|6 to <=12 Years|
280822|NCT00098059|O2|Outcome|2 to <6 Years|
280823|NCT00098059|O1|Outcome|1 to < 2 Years|
280824|NCT00098059|O4|Outcome|13 to <= 18 Years|
280825|NCT00098059|O3|Outcome|6 to <=12 Years|
280826|NCT00098059|O2|Outcome|2 to <6 Years|
280827|NCT00098059|O1|Outcome|1 to < 2 Years|
280828|NCT00098059|O4|Outcome|13 to < =18 Years|
280829|NCT00098059|O3|Outcome|6 to <=12 Years|
280830|NCT00098059|O2|Outcome|2 to <6 Years|
280831|NCT00098059|O1|Outcome|1 to < 2 Years|
280832|NCT00098059|O4|Outcome|13 to <= 18 Years|
280833|NCT00098059|O3|Outcome|6 to <=12 Years|
280834|NCT00098059|O2|Outcome|2 to <6 Years|
280835|NCT00098059|O1|Outcome|1 to < 2 Years|
280836|NCT00098059|O4|Outcome|13 to <= 18 Years|
280837|NCT00098059|O3|Outcome|6 to <=12 Years|
280838|NCT00098059|O2|Outcome|2 to <6 Years|
280839|NCT00098059|O1|Outcome|1 to < 2 Years|
280840|NCT00098059|O4|Outcome|13 to <=18 Years|
280841|NCT00098059|O3|Outcome|6 to <13 Years|
280842|NCT00098059|O2|Outcome|2 to <6 Years|
280843|NCT00098059|O1|Outcome|1 to < 2 Years|
280844|NCT00098059|O4|Outcome|13 to <=18 Years|
280845|NCT00098059|O3|Outcome|6 to <13 Years|
280846|NCT00098059|O2|Outcome|2 to <6 Years|
280852|NCT00098059|E2|Reported Event|Part B (Multiple-dose of Famciclovir)|Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
280853|NCT00098059|E1|Reported Event|Part A (Single-dose of Famciclovir)|Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
280854|NCT00100659|B3|Baseline|Total|Total of all reporting groups
280855|NCT00100659|B2|Baseline|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
280856|NCT00100659|B1|Baseline|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.
Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
280857|NCT00100659|P2|Participant Flow|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
280858|NCT00100659|P1|Participant Flow|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.
Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
280859|NCT00100659|O2|Outcome|PEG/Placebo|Pegylated interferon/placebo
280860|NCT00100659|O1|Outcome|PEG/RV|Pegylated interferon/ribavirin
280861|NCT00100659|E2|Reported Event|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
280862|NCT00100659|E1|Reported Event|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.
Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
280863|NCT00100698|B3|Baseline|Total|Total of all reporting groups
280864|NCT00100698|B2|Baseline|Placebo|placebo subcutaneously once a day
280865|NCT00100698|B1|Baseline|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280866|NCT00100698|P2|Participant Flow|Placebo|placebo subcutaneously once a day
280867|NCT00100698|P1|Participant Flow|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280868|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280869|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280870|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280871|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280872|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280873|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280874|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280875|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280876|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280877|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280878|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280879|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280880|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280881|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280882|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280883|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280884|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280885|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280886|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280887|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280888|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280889|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280890|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280891|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280892|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280893|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280894|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280895|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280896|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280897|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280898|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280899|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280900|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280901|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280902|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
280903|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280904|NCT00100698|E2|Reported Event|Placebo|placebo subcutaneously once a day
280905|NCT00100698|E1|Reported Event|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
280906|NCT00100789|B1|Baseline|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
280907|NCT00100789|P1|Participant Flow|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
280908|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
280909|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
280910|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
280911|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
280912|NCT00100789|E1|Reported Event|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
280913|NCT00100802|B1|Baseline|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.
lomustine: Capsule
temozolomide: Capsule
adjuvant therapy
radiation therapy"
280914|NCT00100802|P1|Participant Flow|Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.
lomustine: Capsule
temozolomide: Capsule
adjuvant therapy
radiation therapy"
280915|NCT00100802|O1|Outcome|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.
lomustine: Capsule
temozolomide: Capsule
adjuvant therapy
radiation therapy"
280916|NCT00100802|O1|Outcome|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.
lomustine: Capsule
temozolomide: Capsule
adjuvant therapy
radiation therapy"
280947|NCT00101036|P2|Participant Flow|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
280917|NCT00100802|E1|Reported Event|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.
lomustine: Capsule
temozolomide: Capsule
adjuvant therapy
radiation therapy"
280918|NCT00100815|B1|Baseline|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
280919|NCT00100815|P1|Participant Flow|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
280920|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
280921|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
280922|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
280923|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
280924|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
280925|NCT00100815|E1|Reported Event|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
280926|NCT00100841|B1|Baseline|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
280927|NCT00100841|P1|Participant Flow|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
280928|NCT00100841|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
280929|NCT00100841|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
280930|NCT00100841|E1|Reported Event|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV"
280931|NCT00100932|B3|Baseline|Total|Total of all reporting groups
280932|NCT00100932|B2|Baseline|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
280933|NCT00100932|B1|Baseline|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
280934|NCT00100932|P2|Participant Flow|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
280935|NCT00100932|P1|Participant Flow|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
280936|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
280937|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
280938|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
280939|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
280940|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
280941|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
280942|NCT00100932|E2|Reported Event|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
280943|NCT00100932|E1|Reported Event|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
280944|NCT00101036|B3|Baseline|Total|Total of all reporting groups
280945|NCT00101036|B2|Baseline|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
280946|NCT00101036|B1|Baseline|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
280951|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
280952|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
280953|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
280954|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
280955|NCT00101036|E2|Reported Event|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
280956|NCT00101036|E1|Reported Event|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
280957|NCT00101101|B1|Baseline|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.
Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.
Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.
Treatment continues in the absence of disease progression or unacceptable toxicity."
280958|NCT00101101|P1|Participant Flow|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.
Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.
Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.
Treatment continues in the absence of disease progression or unacceptable toxicity."
280959|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.
Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.
Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.
Treatment continues in the absence of disease progression or unacceptable toxicity."
280960|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.
Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.
Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.
Treatment continues in the absence of disease progression or unacceptable toxicity."
280961|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.
Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.
Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.
Treatment continues in the absence of disease progression or unacceptable toxicity."
280962|NCT00101101|E1|Reported Event|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.
Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.
Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.
Treatment continues in the absence of disease progression or unacceptable toxicity."
280963|NCT00101166|B1|Baseline|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
280964|NCT00101166|P1|Participant Flow|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
280965|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
280966|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
280967|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
280968|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
280969|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
280970|NCT00101166|E1|Reported Event|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
280971|NCT00101192|B1|Baseline|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
280972|NCT00101192|P1|Participant Flow|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
280973|NCT00101192|O1|Outcome|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
280974|NCT00101192|E1|Reported Event|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
280975|NCT00101283|B3|Baseline|Total|Total of all reporting groups
280976|NCT00101283|B2|Baseline|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
280977|NCT00101283|B1|Baseline|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
280978|NCT00101283|P2|Participant Flow|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
280979|NCT00101283|P1|Participant Flow|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
280980|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
280981|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
280982|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
280983|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
280984|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
280985|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
280986|NCT00101283|E2|Reported Event|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
280987|NCT00101283|E1|Reported Event|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
280988|NCT00101361|B3|Baseline|Total|Total of all reporting groups
280989|NCT00101361|B2|Baseline|Placebo|placebo
280990|NCT00101361|B1|Baseline|Oxandrolone|Oxandrolone
280991|NCT00101361|P2|Participant Flow|2 Placebo|placebo - two capsules twice daily
280992|NCT00101361|P1|Participant Flow|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
280993|NCT00101361|O2|Outcome|2 Placebo|placebo - two capsules twice daily
280994|NCT00101361|O1|Outcome|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
280995|NCT00101361|E2|Reported Event|2 Placebo|placebo - two capsules twice daily
280996|NCT00101361|E1|Reported Event|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
280997|NCT00101400|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
280998|NCT00101400|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
280999|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
281000|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
281001|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
281002|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
281003|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
281004|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
281005|NCT00101400|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
281006|NCT00101413|B1|Baseline|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
281007|NCT00101413|P1|Participant Flow|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
281008|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
281009|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
281010|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
281011|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
281012|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
281013|NCT00101413|E1|Reported Event|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
281014|NCT00101439|B3|Baseline|Total|Total of all reporting groups
281015|NCT00101439|B2|Baseline|Placebo→ Ezetimibe|After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.
281016|NCT00101439|B1|Baseline|Ezetimibe→Placebo|After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks.
281017|NCT00101439|P2|Participant Flow|Placebo→ Ezetimibe|After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.
281018|NCT00101439|P1|Participant Flow|Ezetimibe→Placebo|After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks.
281019|NCT00101439|O2|Outcome|Placebo|Participants who received placebo in active treatment period regardless of randomly assigned sequence
281020|NCT00101439|O1|Outcome|Ezetimibe|Participants who received ezetimibe 10 mg in active treatment period regardless of randomly assigned sequence
281021|NCT00101439|O2|Outcome|Placebo|Participants who received placebo in active treatment period regardless of randomly assigned sequence
281022|NCT00101439|O1|Outcome|Ezetimibe|Participants who received ezetimibe 10 mg in active treatment period regardless of randomly assigned sequence
281023|NCT00101439|E2|Reported Event|Placebo|Participants received placebo once daily for 4 weeks
281024|NCT00101439|E1|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe once daily for 4 weeks
281025|NCT00101452|B4|Baseline|Total|Total of all reporting groups
281026|NCT00101452|B3|Baseline|3. Placebo|Sugar Pill- contains no active ingrediants
281027|NCT00101452|B2|Baseline|2. Escitalopram|A selective serotonin reuptake inhibitor (SSRI)
281028|NCT00101452|B1|Baseline|1. SAMe|a naturally occurring substance
281029|NCT00101452|P3|Participant Flow|3. Placebo|Placebo is a non-active treatment, sometimes called a sugar pill.
281030|NCT00101452|P2|Participant Flow|2. Escitalopram|Patients start with 10mg/day for the first 6 weeks. If they do not feel better after 6 weeks, they can increase to 20mg/day.
281031|NCT00101452|P1|Participant Flow|1. SAMe|Patients start with 1600mg/day for the first. If they do not feel better after 6 weeks, they may increase to 3200mg/day if their lab tests are normal.
281032|NCT00101452|O3|Outcome|3. Placebo|Sugar Pill- contains no active ingrediants
281033|NCT00101452|O2|Outcome|2. Escitalopram|A selective serotonin reuptake inhibitor (SSRI)
281034|NCT00101452|O1|Outcome|1. SAMe|a naturally occurring substance
281035|NCT00101452|E7|Reported Event|7. SAMe Plus Escitalopram (Weeks 12-24, Cross-over)|A naturally occurring substance (S-adenosyl methionine) plus a selective serotonin reuptake inhibitor (SSRI)
281036|NCT00101452|E6|Reported Event|6. Placebo (Weeks 12-24, Continuation)|Sugar Pill- contains no active ingredients
281037|NCT00101452|E5|Reported Event|5. Escitalopram (Weeks 12-24, Continuation)|A selective serotonin reuptake inhibitor (SSRI)
281038|NCT00101452|E4|Reported Event|4. SAMe (Weeks 12-24, Continuation)|A naturally occurring substance (S-adenosyl methionine)
281039|NCT00101452|E3|Reported Event|3. Placebo (Weeks 1-12)|Sugar Pill- contains no active ingredients
281040|NCT00101452|E2|Reported Event|2. Escitalopram (Weeks 1-12)|A selective serotonin reuptake inhibitor (SSRI)
281041|NCT00101452|E1|Reported Event|1. SAMe (Weeks 1-12)|A naturally occurring substance (S-adenosyl methionine)
281042|NCT00101582|B3|Baseline|Total|Total of all reporting groups
281043|NCT00101582|B2|Baseline|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
281044|NCT00101582|B1|Baseline|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
281045|NCT00101582|P2|Participant Flow|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43.
281046|NCT00101582|P1|Participant Flow|Placebo|Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43.
281047|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
281048|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
328428|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
281049|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
281050|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
281051|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
281052|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
281053|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
281054|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
281055|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
281056|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
281057|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
281058|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
281059|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
281060|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
281061|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
281062|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
281063|NCT00101582|E2|Reported Event|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
281064|NCT00101582|E1|Reported Event|Placebo|Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
281065|NCT00101647|B3|Baseline|Total|Total of all reporting groups
281066|NCT00101647|B2|Baseline|Imatinib-resistant|Defined as any of the following: i) initial diagnosis of chronic phase of chronic myeloid leukemia (CML) that progressed to accelerated phase while on treatment with imatinib ≥ 400 mg/day (primary or acquired resistance); ii) initial diagnosis of accelerated phase CML and failure to achieve a hematologic response after ≥ 4 weeks (or ≥ 2 weeks for subjects showing rapid disease progression) of imatinib ≥ 600 mg/day; the required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant to ≥ 600 mg/day (primary resistance); iii) initial diagnosis of accelerated or blast phase CML that progressed to accelerated phase CML following an initial hematologic response to imatinib ≥ 600 mg/day (acquired resistance). The required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant of ≥ 600 mg/day.
281067|NCT00101647|B1|Baseline|Imatinib-intolerant|Defined as either: i) toxicity that was considered at least possibly related to imatinib ≤ 400 mg/day that led to a discontinuation of imatinib therapy; ii) ability to tolerate only < 400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses, was not considered imatinib-tolerant.
281068|NCT00101647|P2|Participant Flow|Imatinib-resistant|Defined as any of the following: i) initial diagnosis of chronic phase of chronic myeloid leukemia (CML) that progressed to accelerated phase while on treatment with imatinib ≥ 400 mg/day (primary or acquired resistance); ii) initial diagnosis of accelerated phase CML and failure to achieve a hematologic response after ≥ 4 weeks (or ≥ 2 weeks for subjects showing rapid disease progression) of imatinib ≥ 600 mg/day; the required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant to ≥ 600 mg/day (primary resistance); iii) initial diagnosis of accelerated or blast phase CML that progressed to accelerated phase CML following an initial hematologic response to imatinib ≥ 600 mg/day (acquired resistance). The required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant of ≥ 600 mg/day.
281069|NCT00101647|P1|Participant Flow|Imatinib-intolerant|Defined as either: i) toxicity that was considered at least possibly related to imatinib ≤ 400 mg/day that led to a discontinuation of imatinib therapy; ii) ability to tolerate only < 400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses, was not considered imatinib-tolerant.
281070|NCT00101647|O3|Outcome|Total|
281071|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281072|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
281073|NCT00101647|O2|Outcome|Day 8|
281074|NCT00101647|O1|Outcome|Day 1|
281075|NCT00101647|O2|Outcome|Day 8|
281076|NCT00101647|O1|Outcome|Day 1|
281077|NCT00101647|O2|Outcome|Day 8|
281078|NCT00101647|O1|Outcome|Day 1|
281079|NCT00101647|O2|Outcome|Study Day 8|
281080|NCT00101647|O1|Outcome|Study Day 1|
281081|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281082|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg BID
281083|NCT00101647|O3|Outcome|Total|
281084|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281085|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
281086|NCT00101647|O2|Outcome|Participants Achieving MCyR|Percentage of participants achieving major cytogenetic response (MCyR), defined as the rate of complete cytogenetic response (CCyR) plus the rate of partial cytogenetic response (PCyR).
281087|NCT00101647|O1|Outcome|Participants Achieving MaHR|Percentage of participants achieving MaHR, defined as best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
281088|NCT00101647|O3|Outcome|Total|
281089|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281090|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
281091|NCT00101647|O3|Outcome|Total|
281092|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281093|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
281094|NCT00101647|O3|Outcome|Total|
281095|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281096|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
281097|NCT00101647|O3|Outcome|Total|
281098|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281099|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
281100|NCT00101647|O3|Outcome|Total|
281101|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281102|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
281103|NCT00101647|O3|Outcome|Total|
281104|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281105|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
281106|NCT00101647|O2|Outcome|Total|
281107|NCT00101647|O1|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281108|NCT00101647|O3|Outcome|Total|
281109|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281110|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg BID
281111|NCT00101647|O3|Outcome|Total|
281112|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
281113|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
281114|NCT00101647|E2|Reported Event|Resistant|
281115|NCT00101647|E1|Reported Event|Intolerant|
281116|NCT00101660|B3|Baseline|Total|Total of all reporting groups
281117|NCT00101660|B2|Baseline|Imatinib-resistant|Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm^3; an absolute increase in WBC by more than 50,000/mm^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
281118|NCT00101660|B1|Baseline|Imatinib-intolerant|Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
281119|NCT00101660|P2|Participant Flow|Imatinib-resistant|Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm^3; an absolute increase in WBC by more than 50,000/mm^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
281120|NCT00101660|P1|Participant Flow|Imatinib-intolerant|Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
281121|NCT00101660|O1|Outcome|Dasatinib|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
281122|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|"Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
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281123|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
281124|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
281125|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
281175|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
281126|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
281127|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
281128|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
281129|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
281130|NCT00101660|O1|Outcome|Dasatanib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
281131|NCT00101660|O1|Outcome|Dastinib, 70 mg, BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
281132|NCT00101660|O1|Outcome|Dasatinib, 70 mg, Twice Daily (BID)|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
281133|NCT00101660|E2|Reported Event|Resistant|
281134|NCT00101660|E1|Reported Event|Intolerant|
281135|NCT00101686|B11|Baseline|Total|Total of all reporting groups
281136|NCT00101686|B10|Baseline|Bevacizumab + mIFL + Placebo|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo
281137|NCT00101686|B9|Baseline|Bevacizumab + mIFL + Celecoxib|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
281138|NCT00101686|B8|Baseline|Bevacizumab + FOLFIRI + Placebo|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
281139|NCT00101686|B7|Baseline|Bevacizumab + FOLFIRI + Celecoxib|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib
281140|NCT00101686|B6|Baseline|CapeIRI + Placebo|Irinotecan plus capecitabine (CapeIRI) with placebo
281141|NCT00101686|B5|Baseline|CapeIRI + Celecoxib|Irinotecan plus capecitabine (CapeIRI) with celecoxib
281142|NCT00101686|B4|Baseline|mIFL + Placebo|Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo
281143|NCT00101686|B3|Baseline|mIFL + Celecoxib|Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
281144|NCT00101686|B2|Baseline|FOLFIRI + Placebo|Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
281145|NCT00101686|B1|Baseline|FOLFIRI + Celecoxib|Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib
281146|NCT00101686|P10|Participant Flow|Bevacizumab + mIFL + Placebo|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo
281147|NCT00101686|P9|Participant Flow|Bevacizumab + mIFL + Celecoxib|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
281148|NCT00101686|P8|Participant Flow|Bevacizumab + FOLFIRI + Placebo|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
281149|NCT00101686|P7|Participant Flow|Bevacizumab + FOLFIRI + Celecoxib|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib
281150|NCT00101686|P6|Participant Flow|CapeIRI + Placebo|Irinotecan plus capecitabine (CapeIRI) with placebo
281151|NCT00101686|P5|Participant Flow|CapeIRI + Celecoxib|Irinotecan plus capecitabine (CapeIRI) with celecoxib
281152|NCT00101686|P4|Participant Flow|mIFL + Placebo|Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo
281153|NCT00101686|P3|Participant Flow|mIFL + Celecoxib|Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
281154|NCT00101686|P2|Participant Flow|FOLFIRI + Placebo|Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
281155|NCT00101686|P1|Participant Flow|FOLFIRI + Celecoxib|Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib
281156|NCT00101686|O5|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
281157|NCT00101686|O4|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
281158|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
281159|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
281160|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
281161|NCT00101686|O5|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
281162|NCT00101686|O4|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
281163|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
281164|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
281165|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
281166|NCT00101686|O2|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
281167|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
281168|NCT00101686|O2|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
281169|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
281170|NCT00101686|O2|Outcome|Bevacizumab + mIFL|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
281171|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
281172|NCT00101686|O2|Outcome|Bevacizumab + mIFL|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
281173|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
281174|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
328429|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
281176|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
281177|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
281178|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
281179|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
281180|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
281181|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
281182|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
281183|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
281184|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
281185|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
281186|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
281187|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
281188|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
281189|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
281190|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
281191|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
281192|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
281193|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
281194|NCT00101686|E5|Reported Event|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
281195|NCT00101686|E4|Reported Event|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
281196|NCT00101686|E3|Reported Event|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
281197|NCT00101686|E2|Reported Event|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
281198|NCT00101686|E1|Reported Event|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
281199|NCT00101816|B3|Baseline|Total|Total of all reporting groups
281200|NCT00101816|B2|Baseline|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281201|NCT00101816|B1|Baseline|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281202|NCT00101816|P2|Participant Flow|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281203|NCT00101816|P1|Participant Flow|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281204|NCT00101816|O3|Outcome|Total|
281205|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281229|NCT00101816|O2|Outcome|MCyR|Participants acheiving MCyR, defined as the rate of CCyR plus the rate of Partial Cytogenetic Response
281352|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
281206|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281207|NCT00101816|O2|Outcome|Study Day 8|
281208|NCT00101816|O1|Outcome|Study Day 1|
281209|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281210|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281211|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281212|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281213|NCT00101816|O2|Outcome|Study Day 8|
281214|NCT00101816|O1|Outcome|Study Day 1|
281215|NCT00101816|O2|Outcome|Study Day 8|
281216|NCT00101816|O1|Outcome|Study Day 1|
281217|NCT00101816|O2|Outcome|Study Day 8|
281218|NCT00101816|O1|Outcome|Study Day 1|
281219|NCT00101816|O2|Outcome|Study Day 8|
281220|NCT00101816|O1|Outcome|Study Day 1|
281221|NCT00101816|O2|Outcome|Study Day 8|
281222|NCT00101816|O1|Outcome|Study Day 1|
281223|NCT00101816|O3|Outcome|Total|
281224|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281225|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281226|NCT00101816|O3|Outcome|Total|
281227|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281228|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281230|NCT00101816|O1|Outcome|MaHR|Participants acheiving MaHR, defined as best confirmed response of Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL) of Minore Hematologic Response (MiHR)
281231|NCT00101816|O3|Outcome|Total|
281232|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281233|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281234|NCT00101816|O3|Outcome|Total|
281235|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281236|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281237|NCT00101816|O3|Outcome|Total|
281238|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281239|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281240|NCT00101816|O2|Outcome|Participants Acheiving OHR|OHR=best confirmed response of major or minor hematologic response (MaHR or MiHR).
281241|NCT00101816|O1|Outcome|Participants Acheiving MaHR|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
281242|NCT00101816|O1|Outcome|Participants Acheiving OHR|OHR=best confirmed response of major or minor hematologic response
281243|NCT00101816|O1|Outcome|Participants Acheiving MaHR|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
281244|NCT00101816|O3|Outcome|Total|
281245|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281246|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281283|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281247|NCT00101816|E2|Reported Event|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
281248|NCT00101816|E1|Reported Event|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
281249|NCT00101868|B3|Baseline|Total|Total of all reporting groups
281250|NCT00101868|B2|Baseline|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
281251|NCT00101868|B1|Baseline|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
281252|NCT00101868|P2|Participant Flow|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
281253|NCT00101868|P1|Participant Flow|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
281254|NCT00101868|O2|Outcome|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
281255|NCT00101868|O1|Outcome|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
281256|NCT00101868|O2|Outcome|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
281257|NCT00101868|O1|Outcome|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
281258|NCT00101868|O2|Outcome|Usual Care Discharge, Handwritten|The control intervention was the usual care discharge process. Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post-discharge activities and restrictions, post-discharge diet, post-discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, 1 page of which also included medication instructions and prescriptions.
281284|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281285|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281286|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281259|NCT00101868|O1|Outcome|Discharge Software|Software is computerized-physician-order-entry application for communication at time of hospital discharge to patients, retail pharmacists, and community physicians. Software features included required fields, pick lists, standard drug doses, alerts, reminders, and online reference information. Software prompted discharging physician to enter pending tests and order tests after discharge. Hospital physicians used software on day of discharge and automatically generated 4 discharge documents: personalized letter to outpatient physician with discharge diagnoses, reconciled medication list, diet-activity instructions, patient education materials provided, and follow-up appointments-studies; printed legible prescriptions with information for dispensing pharmacist about changes-deletions in patient's previous regimen; patient instructions with addresses and telephone numbers for follow-up appointments and tests; and printed legible discharge order with aforementioned information.
281260|NCT00101868|E2|Reported Event|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
281261|NCT00101868|E1|Reported Event|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
281262|NCT00101907|B7|Baseline|Total|Total of all reporting groups
281263|NCT00101907|B6|Baseline|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281264|NCT00101907|B5|Baseline|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281265|NCT00101907|B4|Baseline|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281266|NCT00101907|B3|Baseline|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281267|NCT00101907|B2|Baseline|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281268|NCT00101907|B1|Baseline|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
281269|NCT00101907|P6|Participant Flow|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281270|NCT00101907|P5|Participant Flow|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281271|NCT00101907|P4|Participant Flow|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281272|NCT00101907|P3|Participant Flow|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281273|NCT00101907|P2|Participant Flow|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281274|NCT00101907|P1|Participant Flow|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
281275|NCT00101907|O6|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281276|NCT00101907|O5|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281277|NCT00101907|O4|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281278|NCT00101907|O3|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281279|NCT00101907|O2|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281280|NCT00101907|O1|Outcome|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
281281|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281282|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281287|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281288|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281289|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281290|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281291|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281292|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281293|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281294|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281295|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281296|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281297|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281298|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281299|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281300|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281301|NCT00101907|O6|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281302|NCT00101907|O5|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281303|NCT00101907|O4|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281304|NCT00101907|O3|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281305|NCT00101907|O2|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281306|NCT00101907|O1|Outcome|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
281307|NCT00101907|E6|Reported Event|75 mg BID AMG 706 + Panitumumab + Gem/CisEdit|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281308|NCT00101907|E5|Reported Event|125 mg QD AMG 706 + Panitumumab + Gem/CisEdit|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281309|NCT00101907|E4|Reported Event|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281310|NCT00101907|E3|Reported Event|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281311|NCT00101907|E2|Reported Event|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
281312|NCT00101907|E1|Reported Event|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
281313|NCT00101933|B3|Baseline|Total|Total of all reporting groups
281314|NCT00101933|B2|Baseline|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
281315|NCT00101933|B1|Baseline|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
328430|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
281316|NCT00101933|P2|Participant Flow|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
281317|NCT00101933|P1|Participant Flow|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
281318|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
281319|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
281320|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
281321|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
281322|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
281323|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
281324|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
281325|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
281326|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
281327|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
281328|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
281329|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
281330|NCT00101933|O1|Outcome|All Implanted Subjects|This group contains all subjects who were implanted. This includes one additional subject over those that were randomized.
281331|NCT00101933|O1|Outcome|All Implanted Subjects|This group contains all subjects who were implanted. This includes one additional subject over those that were randomized.
281332|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
281333|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
281334|NCT00101933|E2|Reported Event|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
281335|NCT00101933|E1|Reported Event|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
281336|NCT00102063|B4|Baseline|Total|Total of all reporting groups
281337|NCT00102063|B3|Baseline|Placebo Group|Participants were given a single pill administered once daily
281338|NCT00102063|B2|Baseline|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
281339|NCT00102063|B1|Baseline|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
281340|NCT00102063|P3|Participant Flow|Placebo Group|Participants were given a single pill administered once daily
281341|NCT00102063|P2|Participant Flow|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
281342|NCT00102063|P1|Participant Flow|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
281343|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
281344|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
281345|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
281346|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
281347|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
281348|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
281349|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
281350|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
281351|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
281353|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
281354|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
281355|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
281356|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
281357|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
281358|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
281359|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
281360|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
281361|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
281362|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
281363|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
281364|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
281365|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
281366|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
281367|NCT00102063|E3|Reported Event|Placebo Group|Participants were given a single pill administered once daily
281368|NCT00102063|E2|Reported Event|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
281369|NCT00102063|E1|Reported Event|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
281370|NCT00102440|B4|Baseline|Total|Total of all reporting groups
281371|NCT00102440|B3|Baseline|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281372|NCT00102440|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281373|NCT00102440|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281374|NCT00102440|P3|Participant Flow|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281375|NCT00102440|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281376|NCT00102440|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281377|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281378|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281379|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281380|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281381|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281382|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281383|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281384|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281385|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281386|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281387|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281388|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281389|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281390|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281391|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281392|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281393|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281394|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281395|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281396|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281397|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281398|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281399|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281400|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281401|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281402|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281403|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281404|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281405|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281406|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281407|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281408|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281409|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281410|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281411|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281412|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281413|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281414|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281415|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281416|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281417|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281418|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281419|NCT00102440|E3|Reported Event|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
281420|NCT00102440|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
281421|NCT00102440|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
281422|NCT00102518|B1|Baseline|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
281423|NCT00102518|P1|Participant Flow|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
281424|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
281425|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
281426|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
281427|NCT00102518|E1|Reported Event|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
281428|NCT00102531|B3|Baseline|Total|Total of all reporting groups
281429|NCT00102531|B2|Baseline|Cisplatin Liposomal 36 mg/m2|"The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
Cisplatin liposomal"
281430|NCT00102531|B1|Baseline|Cisplatin Liposomal 24 mg/m2|"Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
Cisplatin liposomal"
281431|NCT00102531|P2|Participant Flow|Cisplatin Liposomal 36 mg/m2|"The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
Cisplatin liposomal"
281432|NCT00102531|P1|Participant Flow|Cisplatin Liposomal 24 mg/m2|"Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
Cisplatin liposomal"
281433|NCT00102531|O2|Outcome|Cisplatin Liposomal 36 mg/m2|The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
281434|NCT00102531|O1|Outcome|Cisplatin Liposomal 24 mg/m2|Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation
281435|NCT00102531|E2|Reported Event|Cisplatin Liposomal 36 mg/m2|"The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
Cisplatin liposomal"
281436|NCT00102531|E1|Reported Event|Cisplatin Liposomal 24 mg/m2|"Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
Cisplatin liposomal"
281437|NCT00102596|B1|Baseline|All Participants|Baseline is included for all participants who passed screening and received at least 1 dose of 1-octanol, whether in Part A, B or C
281438|NCT00102596|P2|Participant Flow|Part B Then C: Fixed Dose|"In Part B, subjects fasted overnight for 6 hours and received 64 mg/kg 1-octanol at 6AM of both formulations:
1) 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; or 2) a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
At the completion of Parts A and B, an exploratory Part C was added in which subjects fasted overnight for 6 hours and received 128 mg/kg 1-octanol at 6AM of both formulations."
281517|NCT00102687|E1|Reported Event|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281439|NCT00102596|P1|Participant Flow|Part A: Dose Escalation|"Subjects fasted overnight for 6 hours and received 1, 4, 8, 16, 32 and 64 mg/kg 1-octanol at 6AM on different days. There were 2 formulations:
1) 2 participants received 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; and 2) two participants received a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA)."
281440|NCT00102596|O1|Outcome|1-Octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of 1-octanol
281441|NCT00102596|O1|Outcome|1-Octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of the 1-octanol
281442|NCT00102596|O2|Outcome|64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol in a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
281443|NCT00102596|O1|Outcome|64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages.
281444|NCT00102596|O2|Outcome|64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol in a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
281445|NCT00102596|O1|Outcome|64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages.
281446|NCT00102596|E1|Reported Event|1-octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of 1-octanol
281447|NCT00102687|B4|Baseline|Total|Total of all reporting groups
281448|NCT00102687|B3|Baseline|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281449|NCT00102687|B2|Baseline|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281450|NCT00102687|B1|Baseline|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281451|NCT00102687|P5|Participant Flow|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
281452|NCT00102687|P4|Participant Flow|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
281453|NCT00102687|P3|Participant Flow|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281454|NCT00102687|P2|Participant Flow|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281455|NCT00102687|P1|Participant Flow|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281456|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
281457|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
281458|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
281459|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281460|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281461|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281462|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
281463|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
281464|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
281465|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
281466|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
281467|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
281468|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281469|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281470|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281471|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281472|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281473|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281474|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their treatment assigned during the initial study period through month 7 to month 23.
281475|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
281476|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
281477|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281478|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281479|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281480|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281481|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281482|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281483|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
281484|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
281485|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
281486|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281487|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281488|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281489|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281490|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281491|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281492|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
281493|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
281494|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
281495|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
281496|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
281497|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
281498|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281499|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281500|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281501|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281502|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281503|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281504|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281505|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281506|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281507|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281508|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281509|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281510|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281511|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281512|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
281513|NCT00102687|E5|Reported Event|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
281514|NCT00102687|E4|Reported Event|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
281515|NCT00102687|E3|Reported Event|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
281516|NCT00102687|E2|Reported Event|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
281519|NCT00102804|B2|Baseline|Placebo and BSC|"Placebo: IV administration, q 21 days.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281520|NCT00102804|B1|Baseline|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281521|NCT00102804|P2|Participant Flow|Placebo and BSC|"Placebo: IV administration, q 21 days, until disease progression.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281522|NCT00102804|P1|Participant Flow|Pemetrexed and BSC|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression.
Best Supportive Care (BSC): Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281523|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281524|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281525|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281526|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281527|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281528|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281529|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281530|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281531|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281532|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281533|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281534|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281535|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281536|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281537|NCT00102804|E2|Reported Event|Placebo and BSC|"Placebo: IV administration, q 21 days.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281538|NCT00102804|E1|Reported Event|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.
BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
281539|NCT00103012|B4|Baseline|Total|Total of all reporting groups
281540|NCT00103012|B3|Baseline|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
281541|NCT00103012|B2|Baseline|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
281542|NCT00103012|B1|Baseline|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
281543|NCT00103012|P3|Participant Flow|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
281544|NCT00103012|P2|Participant Flow|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
281545|NCT00103012|P1|Participant Flow|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
281546|NCT00103012|O3|Outcome|Influence of Panax Ginseng on Lopinavir Disposition|Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
281547|NCT00103012|O2|Outcome|Influence of Echinacea on Lopinavir Disposition|Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14 days of Echinacea purpurea administration (500 mg three times daily) to healthy human volunteers.
281548|NCT00103012|O1|Outcome|Influence of Ginkgo Biloba on Lopinavir Disposition|Lopinavir pharmacokinetics (administered as lopinavir-ritonavir X 2 weeks) determined before, and after 14 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
281549|NCT00103012|E3|Reported Event|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
281550|NCT00103012|E2|Reported Event|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
281551|NCT00103012|E1|Reported Event|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
281552|NCT00103116|B1|Baseline|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
281553|NCT00103116|P1|Participant Flow|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
281554|NCT00103116|O1|Outcome|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
281555|NCT00103116|O1|Outcome|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
281556|NCT00103116|E1|Reported Event|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
281557|NCT00103142|B3|Baseline|Total|Total of all reporting groups
281558|NCT00103142|B2|Baseline|Experimental PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (Granulocyte-macrophage colony-stimulating factor or GM-CSF) subcutaneous (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
281559|NCT00103142|B1|Baseline|Experimental PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-Carcinoembryonic antigen (CEA)-Mucin 1 (MUC-1)-TRIad of COstimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneous (SC) and intradermally (ID) on days 28, 56, and 84.
281560|NCT00103142|P2|Participant Flow|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
281561|NCT00103142|P1|Participant Flow|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
281562|NCT00103142|O2|Outcome|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
281563|NCT00103142|O1|Outcome|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
281564|NCT00103142|O2|Outcome|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
281565|NCT00103142|O1|Outcome|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-carcinoembryonic antigen (CEA)- mucin 1 (MUC-1)-TRiad of Costimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84.
281566|NCT00103142|E2|Reported Event|Arm II|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
281567|NCT00103142|E1|Reported Event|Arm I|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
281568|NCT00093379|B1|Baseline|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
282099|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
281569|NCT00093379|P1|Participant Flow|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy (XRT) once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor.
281570|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
281571|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
281572|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
281573|NCT00093379|E1|Reported Event|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
281574|NCT00093470|B3|Baseline|Total|Total of all reporting groups
281575|NCT00093470|B2|Baseline|Arm B (Clinical Observation)|"Patients undergo observation only.
Clinical Observation: Undergo observation"
281576|NCT00093470|B1|Baseline|Arm A (Tipifarnib)|"Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tipifarnib: Given PO"
281577|NCT00093470|P2|Participant Flow|Arm B (Clinical Observation)|"Patients undergo observation only.
Clinical Observation: Undergo observation"
281578|NCT00093470|P1|Participant Flow|Arm A (Tipifarnib)|"Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tipifarnib: Given PO"
281579|NCT00093470|O2|Outcome|Arm B (Clinical Observation)|Patients undergo observation only.
281580|NCT00093470|O1|Outcome|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
281581|NCT00093470|O2|Outcome|Arm B (Clinical Observation)|Patients undergo observation only.
281582|NCT00093470|O1|Outcome|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
281583|NCT00093470|E2|Reported Event|Arm B (Clinical Observation)|Patients undergo observation only.
281584|NCT00093470|E1|Reported Event|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
281585|NCT00093496|B3|Baseline|Total|Total of all reporting groups
281586|NCT00093496|B2|Baseline|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281587|NCT00093496|B1|Baseline|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281588|NCT00093496|P2|Participant Flow|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281589|NCT00093496|P1|Participant Flow|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281590|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281611|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
281591|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281592|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281593|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281594|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281595|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281596|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281597|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
281598|NCT00093496|E1|Reported Event|All Patients Receiving Gemcitabine|All patients receiving gemcitabine were combined to analyze toxicity.
281599|NCT00093756|B3|Baseline|Total|Total of all reporting groups
281600|NCT00093756|B2|Baseline|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy > bortezomib: Given IV > paclitaxel: Given IV > carboplatin: Given IV
281601|NCT00093756|B1|Baseline|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy > bortezomib: Given IV > paclitaxel: Given IV > carboplatin: Given IV
281602|NCT00093756|P2|Participant Flow|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
281603|NCT00093756|P1|Participant Flow|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
281604|NCT00093756|O1|Outcome|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
281605|NCT00093756|E2|Reported Event|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
281606|NCT00093756|E1|Reported Event|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
281607|NCT00093782|B1|Baseline|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
281608|NCT00093782|P1|Participant Flow|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
281609|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
281610|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
281612|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
281613|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
281614|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
281615|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
281616|NCT00093782|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
temsirolimus: Given IV
laboratory biomarker analysis: Correlative studies"
281617|NCT00093808|B1|Baseline|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
281618|NCT00093808|P1|Participant Flow|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
281619|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
281620|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
281621|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
281622|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
281623|NCT00093808|E1|Reported Event|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
281624|NCT00093847|B3|Baseline|Total|Total of all reporting groups
281625|NCT00093847|B2|Baseline|Oral Adjunct Placebo|Participants receiving placebo
281626|NCT00093847|B1|Baseline|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
281627|NCT00093847|P2|Participant Flow|Oral Adjunct Placebo|Participants receiving placebo
281628|NCT00093847|P1|Participant Flow|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
281629|NCT00093847|O2|Outcome|Oral Adjunct Placebo|Participants receiving placebo
281630|NCT00093847|O1|Outcome|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
281631|NCT00093847|O2|Outcome|Oral Adjunct Placebo|Participants receiving placebo
281632|NCT00093847|O1|Outcome|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
281633|NCT00093847|E2|Reported Event|Oral Adjunct Placebo|Participants receiving placebo
281634|NCT00093847|E1|Reported Event|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
281635|NCT00094055|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281636|NCT00094055|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281637|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281794|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane
Etoposide
Doxorubicin
Cisplatin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
281638|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281639|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281640|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281641|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281642|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281643|NCT00094055|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281644|NCT00094094|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281645|NCT00094094|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281646|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281647|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281648|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281649|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281650|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281651|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281652|NCT00094094|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
281653|NCT00094107|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
281654|NCT00094107|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
281655|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
281656|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
281657|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
281658|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
281659|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
281660|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
281661|NCT00094107|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
281662|NCT00094172|B3|Baseline|Total|Total of all reporting groups
281663|NCT00094172|B2|Baseline|Placebo|Non-Active Comparator
281664|NCT00094172|B1|Baseline|Atorvastatin|Drug: Atorvastatin
281665|NCT00094172|P2|Participant Flow|Placebo|Non-Active Comparator
281666|NCT00094172|P1|Participant Flow|Atorvastatin|Drug: Atorvastatin
281667|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
281668|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
281669|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
281670|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
281671|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
281672|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
281673|NCT00094172|E2|Reported Event|Placebo|Non-Active Comparator
281674|NCT00094172|E1|Reported Event|Atorvastatin|Drug: Atorvastatin
281675|NCT00094302|B3|Baseline|Total|Total of all reporting groups
281676|NCT00094302|B2|Baseline|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281677|NCT00094302|B1|Baseline|Placebo|Placebo of spironolactone
281678|NCT00094302|P2|Participant Flow|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281679|NCT00094302|P1|Participant Flow|Placebo|Placebo of spironolactone
281680|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281681|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281682|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281683|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281684|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281685|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281686|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281687|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281688|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281689|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281690|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281691|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281692|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281693|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281694|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281695|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281696|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281697|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281698|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281699|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281700|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281701|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281702|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281703|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281704|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281705|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281706|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281707|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281708|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281709|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
328431|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
281710|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281711|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281712|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281713|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281714|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281715|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281716|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281717|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281718|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281719|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281720|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281721|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281722|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281723|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281724|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281725|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281726|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281727|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281728|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281729|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
281730|NCT00094302|E2|Reported Event|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
281731|NCT00094302|E1|Reported Event|Placebo|Placebo of spironolactone
281732|NCT00094328|B1|Baseline|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
281733|NCT00094328|P1|Participant Flow|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
281734|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
281735|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
281736|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
281737|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
281738|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
281739|NCT00094328|E1|Reported Event|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
281740|NCT00094458|B4|Baseline|Total|Total of all reporting groups
281741|NCT00094458|B3|Baseline|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
282698|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
281742|NCT00094458|B2|Baseline|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281743|NCT00094458|B1|Baseline|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281744|NCT00094458|P6|Participant Flow|Infliximab + Azathioprine/Infliximab|Participants received daily AZA oral capsules 2.5mg/kg/day and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
281745|NCT00094458|P5|Participant Flow|Infliximab + Placebo/Infliximab|Participants received Placebo oral capsules daily and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
281746|NCT00094458|P4|Participant Flow|Azathioprine + Placebo/Infliximab|Participants received daily AZA oral capsules 2.5mg/kg/day and Placebo infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (EU and Israel) open-Label Extension.
281747|NCT00094458|P3|Participant Flow|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281748|NCT00094458|P2|Participant Flow|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281749|NCT00094458|P1|Participant Flow|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281750|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281751|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281752|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281753|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281754|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281755|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281756|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281757|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281758|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281759|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281760|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281761|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281762|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281763|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281764|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281765|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281766|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281767|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281768|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281769|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281795|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane
Streptozotocin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
281770|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281771|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281772|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281773|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281774|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281775|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281776|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
281777|NCT00094458|E9|Reported Event|OLE-Infliximab + Azathioprine/Infliximab|Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
281778|NCT00094458|E8|Reported Event|OLE-Infliximab + Placebo/Infliximab|Placebo (PBO) oral capsules daily and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
281779|NCT00094458|E7|Reported Event|OLE-Azathioprine + Placebo/Infliximab|Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and Placebo (PBO) infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
281780|NCT00094458|E6|Reported Event|W50-Infliximab + Azathioprine|Azathioprine (AZA) oral capsules daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
281781|NCT00094458|E5|Reported Event|W50-Infliximab + Placebo|Placebo (PBO) oral capsules daily and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
281782|NCT00094458|E4|Reported Event|W50-Azathioprine + Placebo|(AZA) oral daily 2.5 mg/kg/day and Placebo (PBO) infusion Week 30 through Week 50.
281783|NCT00094458|E3|Reported Event|W30-Infliximab + Azathioprine|Azathioprine (AZA) oral daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5mg/kg through Week 30.
281784|NCT00094458|E2|Reported Event|W30-Infliximab + Placebo|Placebo (PBO) oral daily and Infliximab (IFX) infusions 5 mg/kg through Week 30.
281785|NCT00094458|E1|Reported Event|W30-Azathioprine + Placebo|Azathioprine (AZA) oral capsules 2.5 mg/kg/day and Placebo (PBO) infusion through Week 30.
281786|NCT00094497|B3|Baseline|Total|Total of all reporting groups
281787|NCT00094497|B2|Baseline|Sz-M|"streptozotocin and mitotane
Streptozotocin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
281788|NCT00094497|B1|Baseline|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane
Etoposide
Doxorubicin
Cisplatin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
281789|NCT00094497|P2|Participant Flow|Sz-M|"streptozotocin and mitotane
Streptozotocin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
281790|NCT00094497|P1|Participant Flow|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane
Etoposide
Doxorubicin
Cisplatin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
281791|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane
Streptozotocin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
281792|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane
Etoposide
Doxorubicin
Cisplatin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
281793|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane
Streptozotocin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
281918|NCT00094770|B3|Baseline|Total|Total of all reporting groups
281796|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane
Etoposide
Doxorubicin
Cisplatin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
281797|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane
Streptozotocin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
281798|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane
Etoposide
Doxorubicin
Cisplatin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
281799|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane
Streptozotocin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
281800|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane
Etoposide
Doxorubicin
Cisplatin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
281801|NCT00094497|E2|Reported Event|Sz-M|"streptozotocin and mitotane
Streptozotocin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
281802|NCT00094497|E1|Reported Event|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane
Etoposide
Doxorubicin
Cisplatin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
281803|NCT00094536|B1|Baseline|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
281804|NCT00094536|P1|Participant Flow|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
281805|NCT00094536|O1|Outcome|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
281806|NCT00094536|E1|Reported Event|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
281807|NCT00094575|B3|Baseline|Total|Total of all reporting groups
281808|NCT00094575|B2|Baseline|Open Repair|Standard Open Repair
281809|NCT00094575|B1|Baseline|Endovascular Repair|Endovascular Repair
281810|NCT00094575|P2|Participant Flow|Open Repair|Standard Open Repair
281811|NCT00094575|P1|Participant Flow|Endovascular Repair|Endovascular Repair
281812|NCT00094575|O2|Outcome|Standard Open Repair|
281813|NCT00094575|O1|Outcome|Endovascular Repair|
281814|NCT00094575|O2|Outcome|Standard Open Repair|
281815|NCT00094575|O1|Outcome|Endovascular Repair|
281816|NCT00094575|O2|Outcome|Standard Open Repair|
281817|NCT00094575|O1|Outcome|Endovascular Repair|
281818|NCT00094575|O2|Outcome|Standard Open Repair|
281819|NCT00094575|O1|Outcome|Endovascular Repair|
281820|NCT00094575|O2|Outcome|Standard Open Repair|
281821|NCT00094575|O1|Outcome|Endovascular Repair|
281822|NCT00094575|O2|Outcome|Standard Open Repair|
281823|NCT00094575|O1|Outcome|Endovascular Repair|
281824|NCT00094575|O2|Outcome|Open Repair|Standard Open Repair
281825|NCT00094575|O1|Outcome|Endovascular Repair|Endovascular Repair
281826|NCT00094575|O2|Outcome|Open Repair|Standard Open Repair
281827|NCT00094575|O1|Outcome|Endovascular Repair|Endovascular Repair
281828|NCT00094575|E2|Reported Event|Open Repair|Standard Open Repair
281829|NCT00094575|E1|Reported Event|Endovascular Repair|Endovascular Repair
281830|NCT00094653|B4|Baseline|Total|Total of all reporting groups
281831|NCT00094653|B3|Baseline|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281832|NCT00094653|B2|Baseline|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281833|NCT00094653|B1|Baseline|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281834|NCT00094653|P3|Participant Flow|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281835|NCT00094653|P2|Participant Flow|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281836|NCT00094653|P1|Participant Flow|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281837|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281838|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281839|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281840|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281841|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281842|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281843|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281844|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281845|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281846|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281847|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281848|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281849|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281850|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281851|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281852|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281853|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281854|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281855|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281856|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281857|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281858|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281859|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281860|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281861|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281862|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281863|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
282087|NCT00094861|E1|Reported Event|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
281864|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281865|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281866|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281867|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281868|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281869|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281870|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281871|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281872|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281873|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281874|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281875|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281876|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281877|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281878|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281879|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281880|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281881|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281882|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281883|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281884|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281885|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281886|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281887|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281888|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281889|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281890|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
282088|NCT00094887|B3|Baseline|Total|Total of all reporting groups
282089|NCT00094887|B2|Baseline|Placebo|Nitrogen gas
282090|NCT00094887|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
281891|NCT00094653|O2|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281892|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281893|NCT00094653|E3|Reported Event|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281894|NCT00094653|E2|Reported Event|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281895|NCT00094653|E1|Reported Event|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
281896|NCT00094757|B4|Baseline|Total|Total of all reporting groups
281897|NCT00094757|B3|Baseline|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
281898|NCT00094757|B2|Baseline|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281899|NCT00094757|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281900|NCT00094757|P3|Participant Flow|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
281901|NCT00094757|P2|Participant Flow|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281902|NCT00094757|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281903|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
281904|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281905|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281906|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
281907|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281908|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281909|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
281910|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281911|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281912|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
281913|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281914|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281915|NCT00094757|E3|Reported Event|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
281916|NCT00094757|E2|Reported Event|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281917|NCT00094757|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
281919|NCT00094770|B2|Baseline|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281920|NCT00094770|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281921|NCT00094770|P2|Participant Flow|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281922|NCT00094770|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281923|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281924|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281925|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281926|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281927|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281928|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281929|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281930|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281931|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281932|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281933|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281934|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281935|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281936|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281937|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281938|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281939|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281940|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281941|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281942|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281943|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281944|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281945|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281946|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
282091|NCT00094887|P2|Participant Flow|Placebo|Nitrogen gas
282092|NCT00094887|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
282093|NCT00094887|O2|Outcome|Placebo|Nitrogen gas
281947|NCT00094770|E2|Reported Event|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
281948|NCT00094770|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
281949|NCT00094809|B3|Baseline|Total|Total of all reporting groups
281950|NCT00094809|B2|Baseline|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281951|NCT00094809|B1|Baseline|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281952|NCT00094809|P2|Participant Flow|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281953|NCT00094809|P1|Participant Flow|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281954|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281955|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281956|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281957|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281958|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281959|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281960|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281961|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281962|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281963|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281964|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281965|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281966|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281967|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281968|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281969|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281970|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281971|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281972|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281973|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
281974|NCT00094809|E2|Reported Event|Pegfilgrastim|
281975|NCT00094809|E1|Reported Event|Placebo|
281976|NCT00094835|B8|Baseline|Total|Total of all reporting groups
281977|NCT00094835|B7|Baseline|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281978|NCT00094835|B6|Baseline|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281979|NCT00094835|B5|Baseline|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281980|NCT00094835|B4|Baseline|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281981|NCT00094835|B3|Baseline|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281982|NCT00094835|B2|Baseline|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282094|NCT00094887|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
282095|NCT00094887|E2|Reported Event|Placebo|Nitrogen gas
282096|NCT00094887|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
281983|NCT00094835|B1|Baseline|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281984|NCT00094835|P7|Participant Flow|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281985|NCT00094835|P6|Participant Flow|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281986|NCT00094835|P5|Participant Flow|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281987|NCT00094835|P4|Participant Flow|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281988|NCT00094835|P3|Participant Flow|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281989|NCT00094835|P2|Participant Flow|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281990|NCT00094835|P1|Participant Flow|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281991|NCT00094835|O5|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281992|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281993|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281994|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281995|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281996|NCT00094835|O5|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281997|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281998|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
281999|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282000|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282001|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282002|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282699|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282003|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282004|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282005|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282006|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282007|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282008|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282009|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282010|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282011|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282012|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282013|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282014|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282015|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282016|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282017|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282018|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282019|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282020|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282021|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282022|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282097|NCT00094900|B1|Baseline|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282023|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282024|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282025|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282026|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282027|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282028|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282029|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282030|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282031|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282032|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282033|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282034|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282035|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282036|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282037|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282038|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282039|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282040|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282041|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282042|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282098|NCT00094900|P1|Participant Flow|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282043|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282044|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282045|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282046|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282047|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282048|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282049|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282050|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282051|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282052|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282053|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282054|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282055|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282056|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282057|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282058|NCT00094835|E7|Reported Event|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282059|NCT00094835|E6|Reported Event|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282060|NCT00094835|E5|Reported Event|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282061|NCT00094835|E4|Reported Event|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282062|NCT00094835|E3|Reported Event|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282270|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282063|NCT00094835|E2|Reported Event|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282064|NCT00094835|E1|Reported Event|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
282065|NCT00094861|B3|Baseline|Total|Total of all reporting groups
282066|NCT00094861|B2|Baseline|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282067|NCT00094861|B1|Baseline|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282068|NCT00094861|P2|Participant Flow|Palifermin|"Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses. Concurrent radio/chemotherapy (administered for 6 to 7 weeks) was given as follows:
standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy
paclitaxel 50 mg/m^2 IV infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)
carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).
Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0."
282069|NCT00094861|P1|Participant Flow|Placebo|"Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, for a total of 7 doses. Concurrent radio/chemotherapy was given as follows:
standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy
paclitaxel 50 mg/m^2 intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)
carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).
Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0."
282070|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282071|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282072|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282073|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282074|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282075|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282076|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282077|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282078|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282079|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282080|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282081|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282082|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282083|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282084|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282085|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282086|NCT00094861|E2|Reported Event|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
282100|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282101|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282102|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282103|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282104|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282105|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282106|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282107|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282108|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282109|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282110|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282111|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282112|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282113|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282114|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282115|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282116|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282117|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282118|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282119|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282120|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282121|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282122|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282123|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282124|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282125|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282126|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282127|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282128|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282129|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282130|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282131|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282132|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282133|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282134|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282135|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282136|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282137|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282138|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282139|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282140|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282141|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282142|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282143|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282144|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282145|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282146|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282147|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282148|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282149|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282150|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282151|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282152|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282153|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282154|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282155|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282156|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282157|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282158|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282159|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282160|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282161|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282162|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282163|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282164|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282165|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282166|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282167|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282168|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282169|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282170|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282171|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282172|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282173|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282174|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282175|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282176|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282177|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282178|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282179|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282180|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282181|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282182|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282183|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282184|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282185|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282186|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282187|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282188|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282189|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282190|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282191|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282192|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282193|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282194|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282195|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282196|NCT00094900|E1|Reported Event|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
282197|NCT00095056|B3|Baseline|Total|Total of all reporting groups
282198|NCT00095056|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
282199|NCT00095056|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
282200|NCT00095056|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
282201|NCT00095056|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
282202|NCT00095056|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
282271|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282700|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282203|NCT00095056|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
282204|NCT00095056|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
282205|NCT00095056|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
282206|NCT00095056|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
282207|NCT00095056|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
282208|NCT00095121|B3|Baseline|Total|Total of all reporting groups
282209|NCT00095121|B2|Baseline|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282210|NCT00095121|B1|Baseline|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282211|NCT00095121|P2|Participant Flow|PLB - ADV|Placebo (PLB) was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of open-label (OL) ADV treatment (ADV Week 192). Lamivudine was to be added to the open-label ADV regimen of subjects between 12 and <18 years old who had prior lamivudine exposure and who had a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96.
282212|NCT00095121|P1|Participant Flow|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The adefovir dipivoxil (ADV) baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind [DB] ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240). Lamivudine was to be added to the open-label ADV regimen of subjects between 12 and <18 years old who had prior lamivudine exposure and who had a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96.
282213|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282273|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282701|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282214|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282215|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282216|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282217|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282218|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282219|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282220|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282221|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282222|NCT00095121|O2|Outcome|Placebo (PBL)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group for the double-blind treatment period. RAT included adverse events that occurred up to the last dose of double-blind treatment + 4 days or if discontinued early, 30 days after last double-blind dose.
282223|NCT00095121|O1|Outcome|Adefovir Dipivoxil (ADV)|Once daily treatment during the double-blind treatment period: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. Randomized and Treated Analysis Set (RAT) included adverse events that occurred up to the last dose of double-blind treatment + 4 days or if discontinued early, 30 days after last double-blind dose.
282224|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282274|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
328432|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
282225|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282226|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282227|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282228|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282229|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282230|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282231|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282232|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282233|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282234|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282272|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282702|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282235|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282236|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282237|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282238|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282239|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282240|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282241|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282242|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282243|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282244|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282245|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282246|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282247|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
282248|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
282249|NCT00095121|O2|Outcome|Placebo (PLB)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group.
282250|NCT00095121|O1|Outcome|Adefovir Dipivoxil (ADV)|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet.
282251|NCT00095121|E4|Reported Event|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or hepatitis B surface antigen seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 - 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). Treatment-emergent AEs for the OL period are events that began on or after the date of the first dose of OL ADV, and include only new events (ie, events that were never observed during the DB period, or, events observed during the DB period but with greater severity during the OL period).
282252|NCT00095121|E3|Reported Event|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 - 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240). Treatment-emergent AEs for the OL period are events that began on or after the date of the first dose of OL ADV, and include only new events (ie, events that were never observed during the DB period, or, events observed during the DB period but with greater severity during the OL period).
282253|NCT00095121|E2|Reported Event|PLB (Double-Blind)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group for the DB treatment period. Treatment-emergent AEs for the DB period are events that occurred up to the last dose of DB treatment + 4 days or if discontinued early, 30 days after last DB dose.
282254|NCT00095121|E1|Reported Event|ADV (Double-Blind)|Once daily treatment during the DB treatment period: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. Treatment-emergent adverse events (AEs) for the DB period are events that occurred up to the last dose of DB treatment + 4 days or if discontinued early, 30 days after last DB dose.
282255|NCT00095147|B4|Baseline|Total|Total of all reporting groups
282256|NCT00095147|B3|Baseline|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282257|NCT00095147|B2|Baseline|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282258|NCT00095147|B1|Baseline|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282259|NCT00095147|P5|Participant Flow|ABA + MTX [Open-label (OL)]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
282260|NCT00095147|P4|Participant Flow|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282261|NCT00095147|P3|Participant Flow|Placebo (PLA) + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282262|NCT00095147|P2|Participant Flow|Infliximab (INF) + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282263|NCT00095147|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) [Double-blind (DB)]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282264|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
282265|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
282266|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
282267|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282268|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282269|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282703|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282275|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282276|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282277|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282278|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282279|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282280|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282281|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282282|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282283|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282284|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282285|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282286|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282287|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282288|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282289|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282290|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282291|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282292|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282293|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282294|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282295|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282296|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282297|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282298|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282299|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282300|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282301|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282355|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282302|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282303|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282304|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282305|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282306|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282307|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282308|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282309|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282310|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282311|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282312|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282313|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282314|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282315|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282316|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282317|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282318|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282319|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282320|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282321|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282322|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282323|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282324|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282325|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282326|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282327|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282328|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282410|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282329|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282330|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282331|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282332|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282333|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282334|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282335|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282336|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282337|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282338|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282339|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282340|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282341|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282342|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282343|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282344|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282345|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282346|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282347|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282348|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282349|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282350|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282351|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282352|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282353|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282354|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282704|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282356|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282357|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282358|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282359|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282360|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282361|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282362|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282363|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282364|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282365|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282366|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282367|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282368|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282369|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282370|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282371|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282372|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282373|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282374|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282375|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282376|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282377|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282378|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282379|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282380|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282381|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282382|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282436|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282705|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282383|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282384|NCT00095147|O1|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282385|NCT00095147|O2|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282386|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282387|NCT00095147|O3|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282388|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282389|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282390|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282391|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282392|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282393|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282394|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282395|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282396|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282397|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282398|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282399|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282400|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282401|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282402|NCT00095147|O1|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282403|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282404|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282405|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
282406|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
282407|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
282408|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
282409|NCT00095147|O1|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282411|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282412|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282413|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282414|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282415|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282416|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282417|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282418|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282419|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282420|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282421|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282422|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282423|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282424|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282425|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282426|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282427|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282428|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282429|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282430|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282431|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282432|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282433|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282434|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282435|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282706|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282437|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282438|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282439|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282440|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282441|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282442|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282443|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282444|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282445|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282446|NCT00095147|O1|Outcome|ABA + MTX [DB[|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282447|NCT00095147|O2|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282448|NCT00095147|O1|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
282449|NCT00095147|O2|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
282450|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282451|NCT00095147|E4|Reported Event|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, 104 participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
282452|NCT00095147|E3|Reported Event|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly).
282453|NCT00095147|E2|Reported Event|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
282454|NCT00095147|E1|Reported Event|ABA (DB)|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
282455|NCT00103194|B1|Baseline|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
282456|NCT00103194|P1|Participant Flow|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
282457|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
282458|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
282459|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
282642|NCT00104104|E2|Reported Event|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
282460|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
282461|NCT00103194|E1|Reported Event|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
282462|NCT00103207|B1|Baseline|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.
Only eligible patients with confirmed diagnosis are included in the main analysis."
282463|NCT00103207|P1|Participant Flow|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.
Only eligible patients with confirmed diagnosis are included in the main analysis."
282464|NCT00103207|O2|Outcome|Former/Current Smoker|Eligible and treated patients who are former or current smokers.
282465|NCT00103207|O1|Outcome|Never Smoker|Eligible and treated patients who never smoked.
282466|NCT00103207|O2|Outcome|Former/Current Smoker|Eligible and treated patients who are former or current smokers.
282467|NCT00103207|O1|Outcome|Never Smoker|Eligible and treated patients who never smoked.
282468|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.
Only eligible patients with confirmed diagnosis are included in the main analysis."
282469|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.
Only eligible patients with confirmed diagnosis are included in the main analysis."
282470|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.
Only eligible patients with confirmed diagnosis are included in the main analysis."
282471|NCT00103207|E1|Reported Event|Cetuximab|All treated patients were evaluated for toxicities.
282472|NCT00103259|B3|Baseline|Total|Total of all reporting groups
282473|NCT00103259|B2|Baseline|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
282474|NCT00103259|B1|Baseline|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
282475|NCT00103259|P2|Participant Flow|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
282476|NCT00103259|P1|Participant Flow|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
282477|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
282478|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
282479|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
282480|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
282481|NCT00103259|O1|Outcome|Cross-over From Bortezomib to Combined Arm|Patients progressed on bortezomib in step 1 crossed over to the combination arm. Response rate is evaluated in these patients.
282482|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
282483|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
282484|NCT00103259|E3|Reported Event|Cross-over Patients|11 patients crossed over to bortezomib + irinotecan after progressed on bortezomib single agent. Adverse events were reported for the 11 patients while receiving the combination therapy.
282485|NCT00103259|E2|Reported Event|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
282486|NCT00103259|E1|Reported Event|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
282487|NCT00103311|B3|Baseline|Total|Total of all reporting groups
282488|NCT00103311|B2|Baseline|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282489|NCT00103311|B1|Baseline|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282490|NCT00103311|P2|Participant Flow|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282491|NCT00103311|P1|Participant Flow|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282492|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282493|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282494|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282495|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282496|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282497|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282498|NCT00103311|E2|Reported Event|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282499|NCT00103311|E1|Reported Event|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ispinesib: Given IV
laboratory biomarker analysis: Correlative studies"
282500|NCT00103506|B3|Baseline|Total|Total of all reporting groups
282501|NCT00103506|B2|Baseline|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
282502|NCT00103506|B1|Baseline|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
282503|NCT00103506|P2|Participant Flow|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
282504|NCT00103506|P1|Participant Flow|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
282707|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282708|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282505|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
282506|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
282507|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
282508|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
282509|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
282510|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
282511|NCT00103506|E2|Reported Event|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
282512|NCT00103506|E1|Reported Event|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
282513|NCT00103844|B3|Baseline|Total|Total of all reporting groups
282514|NCT00103844|B2|Baseline|Imatinib|Imatinib 400 mg BID
282515|NCT00103844|B1|Baseline|Dasatinib|Dasatinib 70 mg twice a day (BID)
282516|NCT00103844|P2|Participant Flow|Imatinib First|Imatinib 400 mg BID in the first intervention period and, if intolerance to imatinib or progression or lack of efficacy, dasatinib 70 mg BID in the second intervention period (after washout period).
282517|NCT00103844|P1|Participant Flow|Dasatinib First|Dasatinib 70 mg twice a day (BID) in the first intervention period and, if intolerance to dasatinib or progression, imatinib 400 mg BID in the second intervention period (after washout period).
282518|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282519|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282520|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282521|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282522|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282523|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282524|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282525|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282526|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282527|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282528|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282529|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282530|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282531|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282532|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282533|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282534|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282535|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282536|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282537|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282538|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282539|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282540|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282541|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282542|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282543|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
282544|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
282545|NCT00103844|E2|Reported Event|IMATINIB|Imatinib 400 mg BID
282546|NCT00103844|E1|Reported Event|DASATINIB|Dasatinib 70 mg twice a day (BID)
282547|NCT00103857|B8|Baseline|Total|Total of all reporting groups
282548|NCT00103857|B7|Baseline|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
282549|NCT00103857|B6|Baseline|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282709|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282550|NCT00103857|B5|Baseline|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282551|NCT00103857|B4|Baseline|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282552|NCT00103857|B3|Baseline|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282553|NCT00103857|B2|Baseline|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282554|NCT00103857|B1|Baseline|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282555|NCT00103857|P7|Participant Flow|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
282556|NCT00103857|P6|Participant Flow|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282557|NCT00103857|P5|Participant Flow|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282558|NCT00103857|P4|Participant Flow|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282666|NCT00104299|B1|Baseline|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
282559|NCT00103857|P3|Participant Flow|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282560|NCT00103857|P2|Participant Flow|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282561|NCT00103857|P1|Participant Flow|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282562|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282563|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282564|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282565|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282566|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282567|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282643|NCT00104104|E1|Reported Event|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
282644|NCT00104234|B3|Baseline|Total|Total of all reporting groups
282694|NCT00104416|P1|Participant Flow|Double-Blind Phase: Placebo|Control - matching placebo once daily
282568|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282569|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282570|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282571|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282572|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282573|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282574|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282575|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282576|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282645|NCT00104234|B2|Baseline|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
282646|NCT00104234|B1|Baseline|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
282695|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282577|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282578|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282579|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282580|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282581|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282582|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282583|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282584|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282585|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282647|NCT00104234|P2|Participant Flow|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
282648|NCT00104234|P1|Participant Flow|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
282649|NCT00104234|O1|Outcome|All Participants (N=37)|rhASB/rhASB and placebo/rhASB groups were combined for analysis.
282586|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282587|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282588|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282589|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282590|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282591|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282592|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282593|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282594|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282650|NCT00104234|O2|Outcome|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
282651|NCT00104234|O1|Outcome|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
282696|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282595|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282596|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282597|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282598|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282599|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282600|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282601|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282602|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282603|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282652|NCT00104234|O2|Outcome|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
282653|NCT00104234|O1|Outcome|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
282654|NCT00104234|E1|Reported Event|All Participants|rhASB/rhASB and placebo/rhASB groups were combined for analysis.
282655|NCT00104247|B3|Baseline|Total|Total of all reporting groups
282604|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282605|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282606|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282607|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282608|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282609|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282610|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282611|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282612|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282656|NCT00104247|B2|Baseline|Placebo|Placebo
282657|NCT00104247|B1|Baseline|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
282658|NCT00104247|P2|Participant Flow|Placebo|Placebo
282659|NCT00104247|P1|Participant Flow|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
282660|NCT00104247|O2|Outcome|Placebo|Placebo
282613|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282614|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282615|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282616|NCT00103857|E7|Reported Event|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
282617|NCT00103857|E6|Reported Event|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
282618|NCT00103857|E5|Reported Event|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282619|NCT00103857|E4|Reported Event|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282620|NCT00103857|E3|Reported Event|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282621|NCT00103857|E2|Reported Event|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
282661|NCT00104247|O1|Outcome|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
282662|NCT00104247|E2|Reported Event|Placebo|Placebo
282663|NCT00104247|E1|Reported Event|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
282664|NCT00104299|B3|Baseline|Total|Total of all reporting groups
282665|NCT00104299|B2|Baseline|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
282622|NCT00103857|E1|Reported Event|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
282623|NCT00104052|B1|Baseline|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
282624|NCT00104052|P1|Participant Flow|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
282625|NCT00104052|O1|Outcome|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
282626|NCT00104052|E1|Reported Event|PEG-Intron Plus REBETOL|
282627|NCT00104104|B3|Baseline|Total|Total of all reporting groups
282628|NCT00104104|B2|Baseline|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
282629|NCT00104104|B1|Baseline|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
282630|NCT00104104|P2|Participant Flow|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
282631|NCT00104104|P1|Participant Flow|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
282632|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
282633|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
282634|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
282635|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
282636|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
282637|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
282638|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
282639|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
282640|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
282641|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
282667|NCT00104299|P2|Participant Flow|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
282668|NCT00104299|P1|Participant Flow|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
282669|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
282670|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
282671|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
282672|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
282673|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
282674|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
282675|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
282676|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
282677|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
282678|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
282679|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
282680|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
282681|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
282682|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
282683|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
282684|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
282685|NCT00104299|E2|Reported Event|Control Group|"Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled Detailed Description for additional treatment information."
282686|NCT00104299|E1|Reported Event|Rituximab|"Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled Detailed Description for additional treatment information."
282687|NCT00104416|B3|Baseline|Total|Total of all reporting groups
282688|NCT00104416|B2|Baseline|Double-Blind Phase: LTG XR|LTG XR once daily
282689|NCT00104416|B1|Baseline|Double-Blind Phase: Placebo|Control - matching placebo once daily
282690|NCT00104416|P5|Participant Flow|Baseline Failures|Baseline failures who entered the CP without receiving treatment in the Double-Blind Phase. Baseline Failures were participants that successfully progressed through the Screening Phase and completed the Baseline Phase of the Double-blind Study, but ultimately did not meet the seizure frequency criteria for randomization into the Double-Blind Treatment Phase of the study. As a result, they were not counted as having started in the Double-Blind Study, but were eligible to enter the CP of the study.
282691|NCT00104416|P4|Participant Flow|Continuation Phase: LTG/LTG|Participants who received LTG XR in the Double-Blind Phase and then entered the CP, in which they received LTG
282692|NCT00104416|P3|Participant Flow|Continuation Phase: Placebo/LTG|Participants who received placebo in the Double-Blind Phase and then entered the CP, in which they received LTG
282693|NCT00104416|P2|Participant Flow|Double-Blind Phase: LTG XR|Lamotrigine (LTG) extended release (XR) once daily
282710|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282711|NCT00104416|O3|Outcome|Baseline Failures|Baseline failures who entered the CP
282712|NCT00104416|O2|Outcome|Continuation Phase: LTG/LTG|LTG XR participants who entered the CP
282713|NCT00104416|O1|Outcome|Continuation Phase: Placebo/LTG|Placebo participants who entered the CP
282714|NCT00104416|O3|Outcome|Baseline Failures|Baseline failures who entered the CP
282715|NCT00104416|O2|Outcome|Continuation Phase: LTG/LTG|LTG XR participants who entered the CP
282716|NCT00104416|O1|Outcome|Continuation Phase: Placebo/LTG|Placebo participants who entered the CP
282717|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282718|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282719|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282720|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282721|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282722|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282723|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282724|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282725|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282726|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282727|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282728|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282729|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
282730|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
282731|NCT00104416|E5|Reported Event|Baseline Failures|Baseline failures who entered the CP without receiving treatment in the Double-Blind Phase. Baseline Failures were participants that successfully progressed through the Screening Phase and completed the Baseline Phase of the Double-blind Study, but ultimately did not meet the seizure frequency criteria for randomization into the Double-Blind Treatment Phase of the study. As a result, they were not counted as having started in the Double-Blind Study, but were eligible to enter the CP of the study.
282732|NCT00104416|E4|Reported Event|Continuation Phase: LTG/LTG|Participants who received LTG XR in the Double-Blind Phase and then entered the CP, in which they received LTG
282733|NCT00104416|E3|Reported Event|Continuation Phase: Placebo/LTG|Participants who received placebo in the Double-Blind Phase and then entered the CP, in which they received LTG
282734|NCT00104416|E2|Reported Event|Double-Blind Phase: LTG XR|Lamotrigine (LTG) extended release (XR) once daily
282735|NCT00104416|E1|Reported Event|Double-Blind Phase: Placebo|Control - matching placebo once daily
282736|NCT00104520|B3|Baseline|Total|Total of all reporting groups
282737|NCT00104520|B2|Baseline|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282738|NCT00104520|B1|Baseline|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282739|NCT00104520|P2|Participant Flow|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282740|NCT00104520|P1|Participant Flow|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282741|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282742|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282743|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282744|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282745|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282746|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282826|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
282747|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282748|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282749|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282750|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282751|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282752|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282753|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282754|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282755|NCT00104520|E2|Reported Event|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282756|NCT00104520|E1|Reported Event|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
282757|NCT00104572|B4|Baseline|Total|Total of all reporting groups
282758|NCT00104572|B3|Baseline|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
282759|NCT00104572|B2|Baseline|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
282760|NCT00104572|B1|Baseline|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
282761|NCT00104572|P3|Participant Flow|Placebo|"9 participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
282762|NCT00104572|P2|Participant Flow|Aromatase Inhibitor|"13 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
282763|NCT00104572|P1|Participant Flow|Transdermal Testosterone|"13 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
282764|NCT00104572|O3|Outcome|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
282765|NCT00104572|O2|Outcome|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
282766|NCT00104572|O1|Outcome|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
282767|NCT00104572|E3|Reported Event|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
282768|NCT00104572|E2|Reported Event|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
282769|NCT00104572|E1|Reported Event|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
328433|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
282770|NCT00104637|B1|Baseline|Randomized Participants|All enrolled and randomized participants who were administered 25 mg Sildenafil and 25mg placebo at 2 different time periods.
282771|NCT00104637|P2|Participant Flow|Placebo /Sildenafil|25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
282772|NCT00104637|P1|Participant Flow|Sildenafil /Placebo|25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
282773|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
282774|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
282775|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
282776|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
282777|NCT00104637|O2|Outcome|Placebo|Participants that received Placebo
282778|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
282779|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
282780|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
282781|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
282782|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
282783|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
282784|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
282785|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
282786|NCT00104637|O1|Outcome|Sildenafil|Group that received Sildenafil
282787|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
282788|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
282789|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
282790|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
282791|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
282792|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
282793|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
282794|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
282795|NCT00104637|E2|Reported Event|Placebo|25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
282796|NCT00104637|E1|Reported Event|Sildenafil|25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
282797|NCT00104650|B4|Baseline|Total|Total of all reporting groups
282798|NCT00104650|B3|Baseline|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
282799|NCT00104650|B2|Baseline|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
282800|NCT00104650|B1|Baseline|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
282801|NCT00104650|P3|Participant Flow|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
282802|NCT00104650|P2|Participant Flow|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
282803|NCT00104650|P1|Participant Flow|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
282804|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
282805|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
282806|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
282807|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
282808|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
282809|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
282810|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
282811|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
282812|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
282813|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
282814|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
282815|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
282816|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
282817|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
282818|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
282819|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
282820|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
282821|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
282822|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
282823|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
282824|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
282825|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
328434|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
282827|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
282828|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
282829|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
282830|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
282831|NCT00104650|E3|Reported Event|Denosumab 180 mg Q4W|
282832|NCT00104650|E2|Reported Event|Denosumab 180 mg Q12W|
282833|NCT00104650|E1|Reported Event|Bisphosphonate IV Q4W|
282834|NCT00104728|B1|Baseline|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.
At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.
ZD1839 :"
282835|NCT00104728|P1|Participant Flow|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.
At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.
ZD1839 :"
282836|NCT00104728|O1|Outcome|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.
At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.
ZD1839 :"
282837|NCT00104728|O1|Outcome|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.
At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.
ZD1839 :"
282838|NCT00104728|E1|Reported Event|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.
At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.
ZD1839 :"
282839|NCT00104871|B1|Baseline|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
282840|NCT00104871|P1|Participant Flow|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
282841|NCT00104871|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
282842|NCT00104871|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
282843|NCT00104871|E1|Reported Event|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
282844|NCT00104884|B1|Baseline|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
282845|NCT00104884|P1|Participant Flow|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
282846|NCT00104884|O1|Outcome|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
282847|NCT00104884|E1|Reported Event|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
282848|NCT00105001|B4|Baseline|Total|Total of all reporting groups
282849|NCT00105001|B3|Baseline|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO"
282850|NCT00105001|B2|Baseline|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282851|NCT00105001|B1|Baseline|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282852|NCT00105001|P3|Participant Flow|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and Mycophenolate Mofetil [MMF] as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO"
282957|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282853|NCT00105001|P2|Participant Flow|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil [MMF] PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282854|NCT00105001|P1|Participant Flow|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil [MMF] PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282855|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO"
282856|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282857|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282858|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO"
282859|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282860|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282861|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO"
282862|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282863|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282981|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283300|NCT00105586|E2|Reported Event|Escitalopram|Participants will receive escitalopram.
282864|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO"
282865|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282866|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282867|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO"
282868|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282869|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282870|NCT00105001|E3|Reported Event|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO"
282871|NCT00105001|E2|Reported Event|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282872|NCT00105001|E1|Reported Event|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO"
282873|NCT00105027|B7|Baseline|Total|Total of all reporting groups
282874|NCT00105027|B6|Baseline|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282875|NCT00105027|B5|Baseline|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282876|NCT00105027|B4|Baseline|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
282877|NCT00105027|B3|Baseline|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282878|NCT00105027|B2|Baseline|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282879|NCT00105027|B1|Baseline|CRVO Observation|Standard care consists of observation of the macular edema.
282880|NCT00105027|P6|Participant Flow|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282881|NCT00105027|P5|Participant Flow|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282882|NCT00105027|P4|Participant Flow|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
282883|NCT00105027|P3|Participant Flow|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282884|NCT00105027|P2|Participant Flow|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282885|NCT00105027|P1|Participant Flow|CRVO Observation|Standard care consists of observation of the macular edema.
282886|NCT00105027|O6|Outcome|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282887|NCT00105027|O5|Outcome|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282888|NCT00105027|O4|Outcome|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
282889|NCT00105027|O3|Outcome|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282890|NCT00105027|O2|Outcome|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282891|NCT00105027|O1|Outcome|CRVO Observation|Standard care consists of observation of the macular edema.
282892|NCT00105027|E6|Reported Event|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282893|NCT00105027|E5|Reported Event|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282894|NCT00105027|E4|Reported Event|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
283301|NCT00105586|E1|Reported Event|Placebo|Participants will receive a placebo.
282895|NCT00105027|E3|Reported Event|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282896|NCT00105027|E2|Reported Event|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
282897|NCT00105027|E1|Reported Event|CRVO Observation|Standard care consists of observation of the macular edema.
282898|NCT00105066|B3|Baseline|Total|Total of all reporting groups
282899|NCT00105066|B2|Baseline|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
282900|NCT00105066|B1|Baseline|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
282901|NCT00105066|P2|Participant Flow|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
282902|NCT00105066|P1|Participant Flow|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
282903|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
282904|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
282905|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
282906|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
282907|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
282908|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
282909|NCT00105066|E2|Reported Event|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
282910|NCT00105066|E1|Reported Event|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
282911|NCT00105079|B3|Baseline|Total|Total of all reporting groups
282912|NCT00105079|B2|Baseline|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282913|NCT00105079|B1|Baseline|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282914|NCT00105079|P2|Participant Flow|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282915|NCT00105079|P1|Participant Flow|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282916|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282917|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282918|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282919|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282920|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282921|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282922|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282923|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282924|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282925|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282926|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282927|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282928|NCT00105079|E2|Reported Event|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282929|NCT00105079|E1|Reported Event|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
282930|NCT00105157|B5|Baseline|Total|Total of all reporting groups
282931|NCT00105157|B4|Baseline|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282932|NCT00105157|B3|Baseline|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282933|NCT00105157|B2|Baseline|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283302|NCT00105989|B1|Baseline|Duloxetine|duloxetine 60-120 mg QD
282934|NCT00105157|B1|Baseline|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282935|NCT00105157|P4|Participant Flow|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282936|NCT00105157|P3|Participant Flow|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282937|NCT00105157|P2|Participant Flow|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282938|NCT00105157|P1|Participant Flow|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282939|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282940|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282941|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282942|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282943|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282944|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282945|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282946|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282947|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282948|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282949|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282950|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282951|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282952|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282953|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282954|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282955|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282956|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
328435|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
282958|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282959|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282960|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282961|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282962|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282963|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282964|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282965|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282966|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282967|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282968|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282969|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282970|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282971|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282972|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282973|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282974|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282975|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282976|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282977|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282978|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282979|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282980|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283396|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
282982|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282983|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282984|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282985|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282986|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282987|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282988|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282989|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282990|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282991|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282992|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282993|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282994|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282995|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282996|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282997|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
282998|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
282999|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283000|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283001|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283002|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283003|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283004|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283447|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283005|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283006|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283007|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283008|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283009|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283010|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283011|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283012|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283013|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283014|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283015|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283016|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283017|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283018|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283019|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283020|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283021|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283022|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283023|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283024|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283025|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283026|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283027|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283097|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
328436|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
283028|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283029|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283030|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283031|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283032|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283033|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283034|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283035|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283036|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283037|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283038|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283039|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283040|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283041|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283042|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283043|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283044|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283045|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283046|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283047|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283048|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283049|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283050|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283121|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
328437|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
283051|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283052|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283053|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283054|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283055|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283056|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283057|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283058|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283059|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283060|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283061|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283062|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283063|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283064|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283065|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283066|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283067|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283068|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283069|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283070|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283071|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283072|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283073|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283170|NCT00105196|P1|Participant Flow|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283074|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283075|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283076|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283077|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283078|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283079|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283080|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283081|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283082|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283083|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283084|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283085|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283086|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283087|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283088|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283089|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283090|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283091|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283092|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283093|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283094|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283095|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283096|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283497|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283098|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283099|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283100|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283101|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283102|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283103|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283104|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283105|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283106|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283107|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283108|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283109|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283110|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283111|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283112|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283113|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283114|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283115|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283116|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283117|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283118|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283119|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283120|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283576|NCT00106249|B3|Baseline|Total|Total of all reporting groups
283122|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283123|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283124|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283125|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
283126|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283127|NCT00105157|E2|Reported Event|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
283128|NCT00105157|E1|Reported Event|MK0518|Includes patients from the MK0518 200 mg, 400 mg, and 600 mg b.i.d. dose groups. Patients who completed at least 24 weeks of double-blind therapy without virologic failure entered the open-label phase to receive open-label MK0518 400 mg b.i.d.
283129|NCT00105183|B4|Baseline|Total|Total of all reporting groups
283130|NCT00105183|B3|Baseline|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283131|NCT00105183|B2|Baseline|Placebo|USP 0.9% sodium chloride solution
283132|NCT00105183|B1|Baseline|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283133|NCT00105183|P3|Participant Flow|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283134|NCT00105183|P2|Participant Flow|Placebo|USP 0.9% sodium chloride solution
283135|NCT00105183|P1|Participant Flow|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283136|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283137|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
283138|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283139|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283140|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
283141|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283142|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283143|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
283144|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283145|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283146|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
283147|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283148|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283149|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
283150|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283151|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283152|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
283153|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283154|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283155|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
283156|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283157|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283158|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
283159|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283160|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283161|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
283162|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283163|NCT00105183|E3|Reported Event|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
283164|NCT00105183|E2|Reported Event|Placebo|USP 0.9% sodium chloride solution
283165|NCT00105183|E1|Reported Event|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
283166|NCT00105196|B3|Baseline|Total|Total of all reporting groups
283167|NCT00105196|B2|Baseline|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283168|NCT00105196|B1|Baseline|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283169|NCT00105196|P2|Participant Flow|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
285219|NCT00110305|E1|Reported Event|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
283171|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283172|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283173|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283174|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283175|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283176|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283177|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283178|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283179|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283180|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283181|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283182|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283183|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283184|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283185|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283186|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
283187|NCT00105196|E2|Reported Event|Placebo|
283188|NCT00105196|E1|Reported Event|Aripiprazole|
283189|NCT00105235|B1|Baseline|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
283190|NCT00105235|P1|Participant Flow|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
283234|NCT00105469|B1|Baseline|AzaSite|"Per protocol population (defined as all randomized
subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of
pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."
283235|NCT00105469|P2|Participant Flow|Tobramycin|
283191|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
283192|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
283193|NCT00105235|O4|Outcome|Discontinued Immunosuppression Withdrawal|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
283194|NCT00105235|O3|Outcome|Completed Withdrawal and Restarted Immunosuppression|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
283195|NCT00105235|O2|Outcome|Completed Withdrawal and Remains Off Immunosuppression|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
283196|NCT00105235|O1|Outcome|Withdrawal Never Started|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
283197|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
283214|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
283236|NCT00105469|P1|Participant Flow|AzaSite|
283198|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
283199|NCT00105235|E1|Reported Event|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
283200|NCT00105443|B3|Baseline|Total|Total of all reporting groups
283201|NCT00105443|B2|Baseline|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
283202|NCT00105443|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
283203|NCT00105443|P4|Participant Flow|B2) Placebo First - Then Open Label Sorafenib Treatment Phase|"Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2, RG4, and RG5 in the Safety section."
283204|NCT00105443|P3|Participant Flow|B1) Placebo - no Open Label Phase|"Sorafenib-matching placebo tablets were orally administered twice daily (bid).
Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2 and RG4 in the Safety section."
283205|NCT00105443|P2|Participant Flow|A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
283206|NCT00105443|P1|Participant Flow|A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
283207|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
283208|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
283209|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
283210|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
283211|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
283212|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
283213|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
283215|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
283216|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
283217|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
283218|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
283219|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
283220|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
283221|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
283222|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
283223|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
283224|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
283225|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
283226|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
283227|NCT00105443|E5|Reported Event|Subjects Switching From Placebo to Sorafenib (Open Label Only)|Reporting Group 5 (RG 5): Participants initially randomized to Placebo who switched to Sorafenib in Open Label phase (data after unblinding only, from Feb 09, 2007 until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid). Note: Safety Data presented here include participants listed in Arm B2 of the Participant Flow section.
283228|NCT00105443|E4|Reported Event|Placebo Arm, Complete Double-Blind Phase|"Reporting Group 4 (RG 4): All participants that initially were randomized to Placebo (data from Placebo patients before unblinding at Feb 09, 2007); Sorafenib-matching placebo tablets were orally administered twice daily (bid).
Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section."
283229|NCT00105443|E3|Reported Event|Sorafenib (Nexavar) Arm Complete (Incl. Open Label Phase)|Reporting Group 3 (RG 3): All participants that initially were randomized to Sorafenib treatment (data before unblinding (= Double-Blind phase) and after unblinding (= Open Label phase)), until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
283230|NCT00105443|E2|Reported Event|Placebo Arm Double-Blind Phase (Interim Data Only)|"Reporting Group 2 (RG 2): All participants in Double-Blind phase randomized to Sorafenib-matching placebo (data before Oct 17, 2006); Sorafenib-matching placebo tablets were orally administered twice daily (bid).
Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section."
283231|NCT00105443|E1|Reported Event|Sorafenib (Nexavar) Arm Double-Blind Phase (Interim Data Only)|Reporting Group 1 (RG 1): All participants in Double-Blind phase randomized to Sorafenib treatment (data before Oct 17, 2006); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
283232|NCT00105469|B3|Baseline|Total|Total of all reporting groups
283233|NCT00105469|B2|Baseline|Tobramycin|"Per protocol population (defined as all randomized
subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of
pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."
283237|NCT00105469|O2|Outcome|Tobramycin|
283238|NCT00105469|O1|Outcome|AzaSite|
283239|NCT00105469|O2|Outcome|Tobramycin|
283240|NCT00105469|O1|Outcome|AzaSite|
283244|NCT00105482|B2|Baseline|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283245|NCT00105482|B1|Baseline|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283246|NCT00105482|P2|Participant Flow|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283247|NCT00105482|P1|Participant Flow|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283248|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283249|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283250|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283251|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283252|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283253|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283254|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283255|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283256|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
285220|NCT00110357|B3|Baseline|Total|Total of all reporting groups
285221|NCT00110357|B2|Baseline|13- to 18-years-old|
283257|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283258|NCT00105482|E2|Reported Event|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283259|NCT00105482|E1|Reported Event|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
283260|NCT00105534|B3|Baseline|Total|Total of all reporting groups
283261|NCT00105534|B2|Baseline|Vehicle|Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
283262|NCT00105534|B1|Baseline|AzaSite|Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
283263|NCT00105534|P2|Participant Flow|Vehicle|
283264|NCT00105534|P1|Participant Flow|AzaSite|
283265|NCT00105534|O2|Outcome|Vehicle|
283266|NCT00105534|O1|Outcome|AzaSite|
283267|NCT00105534|O2|Outcome|Vehicle|
283268|NCT00105534|O1|Outcome|AzaSite|
283269|NCT00105534|E2|Reported Event|Vehicle|
283270|NCT00105534|E1|Reported Event|AzaSite|
283271|NCT00105560|B1|Baseline|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
283272|NCT00105560|P1|Participant Flow|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
283273|NCT00105560|O2|Outcome|Radiation Therapy - 7 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
283274|NCT00105560|O1|Outcome|Radiation Therapy - 5 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
283275|NCT00105560|O2|Outcome|Radiation Therapy - 7 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
283276|NCT00105560|O1|Outcome|Radiation Therapy - 5 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
283277|NCT00105560|O1|Outcome|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
283278|NCT00105560|O3|Outcome|Radiation Therapy - Intermediate-High Risk|radiation therapy: Radiation therapy with proton beam to standard doses
283279|NCT00105560|O2|Outcome|Radiation Therapy - Standard Risk Group|radiation therapy: Radiation therapy with proton beam to standard doses
283280|NCT00105560|O1|Outcome|Radiation Therapy - Overall Study Population|radiation therapy: Radiation therapy with proton beam to standard doses
283281|NCT00105560|O3|Outcome|Radiation Therapy - Intermediate-High Risk|radiation therapy: Radiation therapy with proton beam to standard doses
283282|NCT00105560|O2|Outcome|Radiation Therapy - Standard Risk Group|radiation therapy: Radiation therapy with proton beam to standard doses
283283|NCT00105560|O1|Outcome|Radiation Therapy - Overall Study Population|radiation therapy: Radiation therapy with proton beam to standard doses
283284|NCT00105560|O3|Outcome|Radiation Therapy Intermediate-High Risk|radiation therapy: Radiation therapy with proton beam to standard doses
283285|NCT00105560|O2|Outcome|Radiation Therapy - Standard Risk Group|radiation therapy: Radiation therapy with proton beam to standard doses
283286|NCT00105560|O1|Outcome|Radiation Therapy - Overall Study Population|radiation therapy: Radiation therapy with proton beam to standard doses
283287|NCT00105560|O3|Outcome|Radiation Therapy - 7 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
283288|NCT00105560|O2|Outcome|Radiation Therapy - 5 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
283289|NCT00105560|O1|Outcome|Radiation Therapy - 3 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
283290|NCT00105560|E1|Reported Event|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
283291|NCT00105586|B3|Baseline|Total|Total of all reporting groups
283292|NCT00105586|B2|Baseline|Escitalopram|Participants will receive escitalopram.
283293|NCT00105586|B1|Baseline|Placebo|Participants will receive a placebo.
283294|NCT00105586|P2|Participant Flow|Escitalopram|Participants will receive escitalopram.
283295|NCT00105586|P1|Participant Flow|Placebo|Participants will receive a placebo.
283296|NCT00105586|O2|Outcome|Placebo (2)|"Placebo
Escitalopram: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram."
283297|NCT00105586|O1|Outcome|Escitalopram (1)|"Escitalopram
Escitalopram: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram."
283298|NCT00105586|O2|Outcome|Escitalopram|Participants will receive escitalopram.
283299|NCT00105586|O1|Outcome|Placebo|Participants will receive a placebo.
283303|NCT00105989|P2|Participant Flow|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283304|NCT00105989|P1|Participant Flow|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283305|NCT00105989|O3|Outcome|Duloxetine 120 mg|duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283306|NCT00105989|O2|Outcome|Duloxetine 90 mg|duloxetine 90 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283307|NCT00105989|O1|Outcome|Duloxetine 60 mg|duloxetine 60 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283308|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283309|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283310|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283311|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283312|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283313|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283314|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283315|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283316|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283317|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283318|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283319|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283320|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283321|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283322|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283323|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283324|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283325|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283326|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283327|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283328|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283329|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283330|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283331|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283332|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283333|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283334|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283335|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283336|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283337|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283338|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283339|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283340|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283341|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283342|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283343|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283344|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283345|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283346|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283347|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283348|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283349|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283350|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283351|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283352|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283353|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283354|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283355|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283356|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283357|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283358|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283359|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283360|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283361|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283362|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283363|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg QD
283364|NCT00105989|O1|Outcome|Duloxetine - Acute|duloxetine 60-120 mg QD
283365|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283366|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283367|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283368|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283369|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283370|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283371|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283372|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283373|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283374|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283375|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283376|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283377|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283378|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283379|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283380|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283381|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283382|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283383|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283384|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283385|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283386|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283387|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283388|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283389|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283390|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283391|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283392|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283393|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283394|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283395|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283397|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283398|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283399|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283400|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283401|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283402|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283403|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
283404|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
283405|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283406|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283407|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283408|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283409|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283410|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283411|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
283412|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
283413|NCT00105989|E4|Reported Event|Duloxetine 120 mg|Duloxetine 120 mg
283414|NCT00105989|E3|Reported Event|Duloxetine 90 mg|Duloxetine 90 mg
283415|NCT00105989|E2|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg
283416|NCT00105989|E1|Reported Event|Placebo|Placebo
283417|NCT00106002|B1|Baseline|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
283418|NCT00106002|P1|Participant Flow|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
283419|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
283420|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
283421|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
283422|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
283423|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
283424|NCT00106002|E1|Reported Event|Pemetrexed|Pemetrexed
283425|NCT00106028|B3|Baseline|Total|Total of all reporting groups
283426|NCT00106028|B2|Baseline|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283427|NCT00106028|B1|Baseline|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283428|NCT00106028|P2|Participant Flow|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283429|NCT00106028|P1|Participant Flow|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283430|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283431|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283432|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283433|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283434|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283435|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283436|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283437|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283438|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283439|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283440|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283441|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283442|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283443|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283444|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283445|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283446|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283448|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283449|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283450|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283451|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283452|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283453|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283454|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283455|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283456|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283457|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283458|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283459|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283460|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283461|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283462|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283463|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283464|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283465|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283466|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283467|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283468|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283469|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283470|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283471|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283472|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283473|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283474|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283475|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283476|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283477|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283478|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283479|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283480|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283481|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283482|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283483|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283484|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283485|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283486|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283487|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283488|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283489|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283490|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283491|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283492|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283493|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283494|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283495|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283496|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
285222|NCT00110357|B1|Baseline|1- to 12-years-old|
283498|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283499|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283500|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283501|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283502|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283503|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283504|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283505|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283506|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283507|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283508|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283509|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283510|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283511|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283512|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283513|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283514|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283515|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283516|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283517|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283518|NCT00106028|E4|Reported Event|Years 2 & 3 Risedronate|Years 1-3 Risedronate, Double-Blind Year 1, Open-Label Years 2 & 3
283519|NCT00106028|E3|Reported Event|Years 2 & 3 Placebo-Risedronate|Year 1 Placebo Double-Blind, Years 2 & 3 Open-Label Risedronate
283520|NCT00106028|E2|Reported Event|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
283521|NCT00106028|E1|Reported Event|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
283522|NCT00106080|B3|Baseline|Total|Total of all reporting groups
283523|NCT00106080|B2|Baseline|Control|Usual care
283524|NCT00106080|B1|Baseline|Intervention|Audit and feedback
283525|NCT00106080|P2|Participant Flow|Control (Usual Care)|We solicited control patients' preferences but did not deliver study generated summary reports to patients, surrogates or providers.
283526|NCT00106080|P1|Participant Flow|Intervention (Audit and Feedback)|We solicited patients' preferences for health care communication and treatment in order to generate individualized summary reports of patient's preferences. These individualized summaries of patient's preferences regarding communication about end-of-life care and preferences for end-of-life care were used to activate patients, family members, and healthcare providers.
283527|NCT00106080|O2|Outcome|Control|Usual care
283528|NCT00106080|O1|Outcome|Intervention|Audit and Feedback
283529|NCT00106080|O2|Outcome|Control|Usual care
283530|NCT00106080|O1|Outcome|Intervention|Audit and Feedback
283531|NCT00106080|E2|Reported Event|Control|Usual care
283532|NCT00106080|E1|Reported Event|Intervention|Audit and Feedback
283533|NCT00106106|B3|Baseline|Total|Total of all reporting groups
283534|NCT00106106|B2|Baseline|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
283535|NCT00106106|B1|Baseline|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
283536|NCT00106106|P2|Participant Flow|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
283537|NCT00106106|P1|Participant Flow|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
283538|NCT00106106|O2|Outcome|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
283539|NCT00106106|O1|Outcome|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
283540|NCT00106106|O2|Outcome|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
283541|NCT00106106|O1|Outcome|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
283542|NCT00106106|E2|Reported Event|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
283543|NCT00106106|E1|Reported Event|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
283544|NCT00106119|B1|Baseline|Entire Study Population|Includes groups randomized to receive Levothyroxine first and Liothyronine first.
283545|NCT00106119|P2|Participant Flow|Levothyroxine First, Then Liothyronine|Levothyroxine (dose of 5, 10, or 33 mcg) in first intervention period and Liothyronine (dose of 2.5, 10, or 16 mcg) in second intervention period (after washout period)
283546|NCT00106119|P1|Participant Flow|Liothyronine First, Then Levothyroxine|Liothyronine (dose of 2.5, 10, or 16 mcg) in first intervention period and Levothyroxine (dose of 5, 10, or 33 mcg) in second intervention period (after washout period)
283547|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283548|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283549|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283550|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283551|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283552|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283553|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention ArmArm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283554|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283555|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283556|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283557|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283558|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283559|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283560|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
283561|NCT00106119|E2|Reported Event|Liothyronine Period|Patients at Liothyronine Period
283562|NCT00106119|E1|Reported Event|Levothyroxine Period|Patients at Levothyroxine Period
283563|NCT00106184|B3|Baseline|Total|Total of all reporting groups
283564|NCT00106184|B2|Baseline|Group B|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)
Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9
Treatment Group B: placebo infusion at Weeks 0 and 1"
283565|NCT00106184|B1|Baseline|Group A|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)
Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1
Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
283566|NCT00106184|P2|Participant Flow|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)
Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9
Treatment Group B: placebo infusion at Weeks 0 and 1"
283567|NCT00106184|P1|Participant Flow|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)
Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
283568|NCT00106184|O2|Outcome|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)
Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9
Treatment Group B: placebo infusion at Weeks 0 and 1"
283569|NCT00106184|O1|Outcome|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)
Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
283570|NCT00106184|O2|Outcome|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)
Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9
Treatment Group B: placebo infusion at Weeks 0 and 1"
283571|NCT00106184|O1|Outcome|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)
Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
283572|NCT00106184|O2|Outcome|Group B (Rituximab Wks 8 and 9)|"Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9
Treatment Group B: placebo infusion at Weeks 0 and 1"
283573|NCT00106184|O1|Outcome|Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)
Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1
Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
283574|NCT00106184|E2|Reported Event|Treatment Group B|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)
Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9
Treatment Group B: placebo infusion at Weeks 0 and 1"
283575|NCT00106184|E1|Reported Event|Treatment Group A|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)
Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
283577|NCT00106249|B2|Baseline|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
283578|NCT00106249|B1|Baseline|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
283579|NCT00106249|P2|Participant Flow|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
283580|NCT00106249|P1|Participant Flow|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
283581|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
283582|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
283583|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
283584|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
283585|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
283586|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
283587|NCT00106249|E2|Reported Event|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
283588|NCT00106249|E1|Reported Event|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
283589|NCT00106353|B3|Baseline|Total|Total of all reporting groups
283590|NCT00106353|B2|Baseline|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283591|NCT00106353|B1|Baseline|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
283592|NCT00106353|P7|Participant Flow|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283593|NCT00106353|P6|Participant Flow|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283594|NCT00106353|P5|Participant Flow|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283595|NCT00106353|P4|Participant Flow|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283596|NCT00106353|P3|Participant Flow|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283597|NCT00106353|P2|Participant Flow|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283598|NCT00106353|P1|Participant Flow|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligram per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283599|NCT00106353|O2|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283600|NCT00106353|O1|Outcome|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
283601|NCT00106353|O2|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
284243|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
283602|NCT00106353|O1|Outcome|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
283603|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283604|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283605|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283606|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283607|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283608|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
283609|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283610|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283611|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283612|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283613|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283614|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283615|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283616|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion..
283617|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283618|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283619|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283620|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283621|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283622|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283623|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283624|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283625|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283626|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283627|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283628|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283629|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283630|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283631|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283632|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283633|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283634|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283635|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283636|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283637|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283638|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283639|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283640|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283641|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
285223|NCT00110357|P2|Participant Flow|13- to 18-years-old|
283642|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283643|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283644|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283645|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283646|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283647|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
283648|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283649|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283650|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283651|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283652|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283653|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283654|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283655|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283656|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283657|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283658|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283659|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283660|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283661|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283662|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283663|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283664|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283665|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283666|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283667|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283668|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283669|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283670|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283671|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283672|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283673|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283674|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283675|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283676|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283677|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283678|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283679|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283680|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283681|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
285224|NCT00110357|P1|Participant Flow|1- to 12-years-old|
283682|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283683|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283684|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283685|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283686|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283687|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283688|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283689|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283690|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283691|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283692|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283693|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283694|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283695|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283696|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283697|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283698|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283699|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283700|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283701|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283702|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283703|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283704|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283705|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283706|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283707|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283708|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283709|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283710|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283711|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283712|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283713|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283714|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
283715|NCT00106353|E7|Reported Event|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283716|NCT00106353|E6|Reported Event|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283717|NCT00106353|E5|Reported Event|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
283718|NCT00106353|E4|Reported Event|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
283719|NCT00106353|E3|Reported Event|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
283720|NCT00106353|E2|Reported Event|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
283721|NCT00106353|E1|Reported Event|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
283722|NCT00106392|B3|Baseline|Total|Total of all reporting groups
283723|NCT00106392|B2|Baseline|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
284244|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
283724|NCT00106392|B1|Baseline|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
283725|NCT00106392|P2|Participant Flow|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
283726|NCT00106392|P1|Participant Flow|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
283727|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
283728|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
283729|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
283730|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
283731|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
283732|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
283733|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
283734|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
283735|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
283736|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
283737|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
283738|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
283739|NCT00106392|E2|Reported Event|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
283740|NCT00106392|E1|Reported Event|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
283741|NCT00098254|B1|Baseline|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283742|NCT00098254|P1|Participant Flow|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283743|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283744|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283745|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283746|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283747|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283748|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283749|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283750|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283751|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
285225|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
283752|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283753|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283754|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283755|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283756|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283757|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283758|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283759|NCT00098254|E1|Reported Event|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
283760|NCT00098293|B4|Baseline|Total|Total of all reporting groups
283761|NCT00098293|B3|Baseline|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, up to week 96 in DB phase. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily from Week 97 up to Week 240 in open-label (OL) phase.
283762|NCT00098293|B2|Baseline|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
283763|NCT00098293|B1|Baseline|Maraviroc Once Daily + CBV (DB)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
283764|NCT00098293|P5|Participant Flow|Maraviroc Twice Daily + CBV (SP)|Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.
283765|NCT00098293|P4|Participant Flow|Maraviroc Twice Daily + CBV (OL)|Participants who received maraviroc 300 mg tablet orally once daily treatment during the DB phase and who were eligible based on safety criteria and virologic response, switched to OL maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, following the DSMB recommendation to terminate the maraviroc once daily treatment arm after planned interim analysis. OL phase continued for at least 3 years after DB phase.
283766|NCT00098293|P3|Participant Flow|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
283767|NCT00098293|P2|Participant Flow|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
283768|NCT00098293|P1|Participant Flow|Maraviroc Once Daily + CBV (DB)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
284245|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
328438|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
283769|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283770|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283771|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283772|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283773|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283774|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283775|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283776|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283777|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283778|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283779|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283780|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283781|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283782|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283783|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283784|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283785|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
284246|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
283786|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283787|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283788|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283789|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283790|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283791|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283792|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283793|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283794|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283795|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283796|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283797|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283798|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283799|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283800|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283801|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
328439|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
283802|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283803|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283804|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283805|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283806|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283807|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283808|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283809|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283810|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283811|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283812|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283813|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283814|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
283815|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283816|NCT00098293|E4|Reported Event|Maraviroc Twice Daily + CBV (SP)|Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.
285226|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
283817|NCT00098293|E3|Reported Event|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
283818|NCT00098293|E2|Reported Event|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
283819|NCT00098293|E1|Reported Event|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
283820|NCT00098306|B4|Baseline|Total|Total of all reporting groups
283821|NCT00098306|B3|Baseline|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283822|NCT00098306|B2|Baseline|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283823|NCT00098306|B1|Baseline|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283824|NCT00098306|P7|Participant Flow|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
283825|NCT00098306|P6|Participant Flow|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
283826|NCT00098306|P5|Participant Flow|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
283827|NCT00098306|P4|Participant Flow|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
283828|NCT00098306|P3|Participant Flow|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283829|NCT00098306|P2|Participant Flow|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283830|NCT00098306|P1|Participant Flow|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283831|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283832|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283833|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283834|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
285227|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
283835|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283836|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283837|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283838|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283839|NCT00098306|O1|Outcome|Maraviroc QD|Description Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283840|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283841|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283842|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283843|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283844|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283845|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283846|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283847|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283848|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283849|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283850|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283851|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283852|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283853|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283854|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283855|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283856|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283857|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283858|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283859|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283860|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283861|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283862|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283863|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283864|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283865|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283866|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283867|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283868|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283869|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283870|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283871|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283872|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283873|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283874|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283875|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283876|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283877|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283878|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283879|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283880|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283881|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283882|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283883|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283884|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283885|NCT00098306|E7|Reported Event|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
283886|NCT00098306|E6|Reported Event|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
283887|NCT00098306|E5|Reported Event|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
283888|NCT00098306|E4|Reported Event|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
283889|NCT00098306|E3|Reported Event|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283890|NCT00098306|E2|Reported Event|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283891|NCT00098306|E1|Reported Event|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283892|NCT00098345|B1|Baseline|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
283893|NCT00098345|P1|Participant Flow|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
283894|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
283895|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
283896|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
283897|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
283898|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
283899|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
283900|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
283901|NCT00098345|E1|Reported Event|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
283902|NCT00098371|B1|Baseline|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
284432|NCT00106535|B3|Baseline|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
283903|NCT00098371|P1|Participant Flow|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.To improve tolerability of treatment regimen, an amendment to the protocol was done to reduce the cycle length from 42 days to 28 days, reducing the number of treatments per cycle from four (days 1, 8, 15 & 22) to three (days 1, 8, and 15).
283904|NCT00098371|O2|Outcome|Non-Responders|Patients who had stable disease (SD) or progressive disease (PD)
283905|NCT00098371|O1|Outcome|Responders|Patients who achieved a partial response (PR)
283906|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
283907|NCT00098371|O6|Outcome|Patients Without Complex Karyotype|Complex Karyotype defined as fewer than three cytogenetic aberrations.
283908|NCT00098371|O5|Outcome|Patients With Complex Karyotype|Complex Karyotype defined as three or more cytogenetic aberrations.
283909|NCT00098371|O4|Outcome|Patients Without Del(11q22.3)|
283910|NCT00098371|O3|Outcome|Patients With Del(11q22.3)|
283911|NCT00098371|O2|Outcome|Patients Without Del(17p13.1)|
283912|NCT00098371|O1|Outcome|Patients With Del(17p13.1)|
283913|NCT00098371|O1|Outcome|Treatment (Alvocidib)|"Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
alvocidib"
283914|NCT00098371|O2|Outcome|Group 2|Patients with dexamethasone
283915|NCT00098371|O1|Outcome|Group 1|Patients without dexamethasone
283916|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
283917|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
283918|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
283919|NCT00098371|O1|Outcome|Treatment (Alvocidib)|"Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
alvocidib"
283920|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
283921|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
283922|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
283923|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
283924|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
283925|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
283926|NCT00098371|E1|Reported Event|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
283927|NCT00098475|B3|Baseline|Total|Total of all reporting groups
283928|NCT00098475|B2|Baseline|Arm II (Lenalidomide, Low-dose Dexamethasone)|"Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase."
283929|NCT00098475|B1|Baseline|Arm I (Lenalidomide, Dexamethasone)|"Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase."
283930|NCT00098475|P4|Participant Flow|Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
283931|NCT00098475|P3|Participant Flow|Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
283932|NCT00098475|P2|Participant Flow|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
283933|NCT00098475|P1|Participant Flow|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
283934|NCT00098475|O2|Outcome|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
283935|NCT00098475|O1|Outcome|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
283936|NCT00098475|O2|Outcome|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
283937|NCT00098475|O1|Outcome|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
283938|NCT00098475|E6|Reported Event|Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
283939|NCT00098475|E5|Reported Event|Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
283940|NCT00098475|E4|Reported Event|Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2|Arm II patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
283941|NCT00098475|E3|Reported Event|Arm I (Lenalidomide, Dexamethasone) Step 2|Arm I patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
283942|NCT00098475|E2|Reported Event|Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
283943|NCT00098475|E1|Reported Event|Arm I (Lenalidomide, Dexamethasone) Step 1|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
283944|NCT00098670|B1|Baseline|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
283945|NCT00098670|P1|Participant Flow|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
283946|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
283947|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
283948|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
283949|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
283950|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
283951|NCT00098670|E2|Reported Event|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction
283952|NCT00098670|E1|Reported Event|FR Induction|Fludarabine and rituximab induction in pts with B-cell CLL
283953|NCT00098722|B4|Baseline|Total|Total of all reporting groups
283954|NCT00098722|B3|Baseline|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283955|NCT00098722|B2|Baseline|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283956|NCT00098722|B1|Baseline|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283957|NCT00098722|P7|Participant Flow|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
283958|NCT00098722|P6|Participant Flow|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
283959|NCT00098722|P5|Participant Flow|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
283960|NCT00098722|P4|Participant Flow|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
283961|NCT00098722|P3|Participant Flow|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283962|NCT00098722|P2|Participant Flow|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283963|NCT00098722|P1|Participant Flow|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283964|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283965|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284030|NCT00098748|P2|Participant Flow|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
286349|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
283966|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283967|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283968|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283969|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283970|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283971|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283972|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283973|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283974|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283975|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283976|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283977|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283978|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283979|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283980|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283981|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283982|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283983|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283984|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283985|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283986|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283987|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283988|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283989|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283990|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283991|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283992|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283993|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283994|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283995|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283996|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
283997|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283998|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
283999|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
284000|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284001|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284002|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
284003|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284004|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284005|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
284006|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284007|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284008|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
284009|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284010|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284011|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
284012|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284013|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284014|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
284015|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284016|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284017|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
284018|NCT00098722|E7|Reported Event|In Study-off Drug, Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
284019|NCT00098722|E6|Reported Event|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
284020|NCT00098722|E5|Reported Event|In Study-off Drug, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
284021|NCT00098722|E4|Reported Event|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
284022|NCT00098722|E3|Reported Event|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284023|NCT00098722|E2|Reported Event|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
284024|NCT00098722|E1|Reported Event|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
284025|NCT00098748|B4|Baseline|Total|Total of all reporting groups
284026|NCT00098748|B3|Baseline|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284027|NCT00098748|B2|Baseline|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284028|NCT00098748|B1|Baseline|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284029|NCT00098748|P3|Participant Flow|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
285228|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
284031|NCT00098748|P1|Participant Flow|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284032|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284033|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284034|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284035|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284036|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284037|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284038|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284039|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284040|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284041|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284042|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284043|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284044|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284045|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284046|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284047|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284048|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284049|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284050|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284051|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284052|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284053|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284054|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284055|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284056|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284057|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284058|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284059|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284247|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
284060|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284061|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284062|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284063|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284064|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284065|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284066|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284067|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284068|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284069|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284070|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284071|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284072|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284073|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284074|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284075|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284076|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284077|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284078|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284079|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284080|NCT00098748|E3|Reported Event|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
284081|NCT00098748|E2|Reported Event|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
284082|NCT00098748|E1|Reported Event|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
284083|NCT00098774|B1|Baseline|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
284084|NCT00098774|P1|Participant Flow|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
284324|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284085|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
284086|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
284087|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
284088|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
284089|NCT00098774|E1|Reported Event|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
284090|NCT00098787|B4|Baseline|Total|Total of all reporting groups
284091|NCT00098787|B3|Baseline|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
284092|NCT00098787|B2|Baseline|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
284093|NCT00098787|B1|Baseline|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
284094|NCT00098787|P3|Participant Flow|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
284095|NCT00098787|P2|Participant Flow|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
284096|NCT00098787|P1|Participant Flow|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
284097|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
284098|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
284099|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
284100|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
328440|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
284101|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
284102|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
284103|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
284104|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
284105|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
284106|NCT00098787|E3|Reported Event|Low or Indeterminate TS: FOLFOX/Bev|Patients with low or intermediate thymidylate synthase (TS) receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
284107|NCT00098787|E2|Reported Event|High TS: FOLFOX/Bev|Patients with high thymidylate synthase (TS) who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in arm I, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
284108|NCT00098787|E1|Reported Event|High TS: IROX/Bev|Patients with high thymidylate synthase (TS) who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol.
284109|NCT00098813|B1|Baseline|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
284110|NCT00098813|P1|Participant Flow|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
284111|NCT00098813|O1|Outcome|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
284112|NCT00098813|E1|Reported Event|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
284113|NCT00098839|B3|Baseline|Total|Total of all reporting groups
284114|NCT00098839|B2|Baseline|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284115|NCT00098839|B1|Baseline|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284116|NCT00098839|P2|Participant Flow|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284192|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|plus NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams
284117|NCT00098839|P1|Participant Flow|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284118|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284119|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284120|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284121|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284122|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284123|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284124|NCT00098839|E2|Reported Event|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284125|NCT00098839|E1|Reported Event|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
L-asparaginase: Given IM
doxorubicin hydrochloride: Given IV
therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID
vincristine sulfate: Given IV
epratuzumab: Given IV
cytarabine: Given IT
prednisone: Given orally
pegaspargase: Given IM
dexrazoxane hydrochloride: Given IV
methotrexate: Given IT
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV
filgrastim: Given SC"
284126|NCT00098865|B1|Baseline|Thalidomide and Temozolomide|"Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression."
284127|NCT00098865|P1|Participant Flow|Thalidomide and Temozolomide|"Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression"
284128|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression
temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.
thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
284129|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression
temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.
thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
284130|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression
temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.
thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
284131|NCT00098865|E1|Reported Event|Thalidomide and Temzolomide|"Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression."
284132|NCT00098956|B1|Baseline|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.
topotecan hydrochloride: Given IV
7-hydroxystaurosporine: Given IV"
284133|NCT00098956|P1|Participant Flow|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.
topotecan hydrochloride: Given IV
7-hydroxystaurosporine: Given IV"
284134|NCT00098956|O1|Outcome|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.
topotecan hydrochloride: Given IV
7-hydroxystaurosporine: Given IV"
284135|NCT00098956|O1|Outcome|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.
topotecan hydrochloride: Given IV
7-hydroxystaurosporine: Given IV"
284193|NCT00099359|O1|Outcome|ARM A (ZDV - Standard of Care)|"ZDV (standard of care), given for 6 weeks:
12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams"
284136|NCT00098956|E1|Reported Event|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.
topotecan hydrochloride: Given IV
7-hydroxystaurosporine: Given IV"
284137|NCT00099021|B1|Baseline|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
284138|NCT00099021|P1|Participant Flow|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
284139|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
284140|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
284141|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
284142|NCT00099021|E1|Reported Event|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
284143|NCT00099047|B3|Baseline|Total|Total of all reporting groups
284144|NCT00099047|B2|Baseline|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
284145|NCT00099047|B1|Baseline|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
284146|NCT00099047|P2|Participant Flow|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
284147|NCT00099047|P1|Participant Flow|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
284148|NCT00099047|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
284149|NCT00099047|O1|Outcome|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
284150|NCT00099047|E2|Reported Event|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
284151|NCT00099047|E1|Reported Event|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
284152|NCT00099268|B3|Baseline|Total|Total of all reporting groups
284153|NCT00099268|B2|Baseline|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284154|NCT00099268|B1|Baseline|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284155|NCT00099268|P2|Participant Flow|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284156|NCT00099268|P1|Participant Flow|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284157|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284158|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284159|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284160|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284161|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284162|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284163|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284241|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
284164|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284165|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284166|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284167|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284168|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284169|NCT00099268|E2|Reported Event|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284170|NCT00099268|E1|Reported Event|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
284171|NCT00099359|B4|Baseline|Total|Total of all reporting groups
284172|NCT00099359|B3|Baseline|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND
NFV, given for 2 weeks:
200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
284173|NCT00099359|B2|Baseline|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)
NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :
12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
284174|NCT00099359|B1|Baseline|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
284175|NCT00099359|P3|Participant Flow|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND
NFV, given for 2 weeks:
200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
284176|NCT00099359|P2|Participant Flow|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)
NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :
12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
284177|NCT00099359|P1|Participant Flow|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
284178|NCT00099359|O1|Outcome|ARM B (ZDV + NVP)|NVP concentrations were measured in 14 infants immediately before the 3rd dose, 4 hours post dose, 1 day post dose, 3-5 days post dose and 7 days post dose.
284179|NCT00099359|O2|Outcome|Uninfected|Infants uninfected after birth
284180|NCT00099359|O1|Outcome|Infected|Infants infected after birth
284181|NCT00099359|O1|Outcome|ARM C (ZDV + 3TC/NFV)|Standard ZDV for 6 weeks combined with 2 weeks of 3TC and NFV. NFV and 3TC plasma concentrations were measured by validated HPLC assays with lower detection limit of 0.04 micrograms/mL.
284182|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND
NFV, given for 2 weeks:
200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
284183|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)
NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :
12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
284184|NCT00099359|O1|Outcome|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
284185|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND
NFV, given for 2 weeks:
200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
284186|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)
NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :
12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
284187|NCT00099359|O1|Outcome|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
284188|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC/NFV)|ZDV + 3TC/NFV
284189|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|ZDV + NVP
284190|NCT00099359|O1|Outcome|ARM A (ZDV Only)|ZDV only
284191|NCT00099359|O3|Outcome|ARM C (ZDV +3TC+NFV)|"ZDV (standard of care) plus 3TC, given for 2 weeks:
6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND
NFV, given for 2 weeks:
200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
284242|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
284194|NCT00099359|E3|Reported Event|ARM C (ZDV + 3TC/NFV)|"ZDV, given for 6 weeks:
12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams AND 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND
NFV, given for 2 weeks:
200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
284195|NCT00099359|E2|Reported Event|ARM B (ZDV + NVP)|"ZDV, given for 6 weeks:
12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams
AND NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :
12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
284196|NCT00099359|E1|Reported Event|ARM A (ZDV Alone)|"ZDV, given for 6 weeks:
12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams"
284197|NCT00099437|B3|Baseline|Total|Total of all reporting groups
284198|NCT00099437|B2|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
284199|NCT00099437|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
284200|NCT00099437|P2|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
284201|NCT00099437|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
284202|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
284203|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
284204|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
284205|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
284206|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
284207|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
284208|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
284209|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
284210|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
284211|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
284212|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
284213|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
284214|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
284215|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
284216|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
284217|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
284218|NCT00099437|E2|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
284219|NCT00099437|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
284220|NCT00099632|B7|Baseline|Total|Total of all reporting groups
284221|NCT00099632|B6|Baseline|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
284222|NCT00099632|B5|Baseline|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
284223|NCT00099632|B4|Baseline|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
284224|NCT00099632|B3|Baseline|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
284225|NCT00099632|B2|Baseline|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
284226|NCT00099632|B1|Baseline|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
284227|NCT00099632|P6|Participant Flow|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
284228|NCT00099632|P5|Participant Flow|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
284229|NCT00099632|P4|Participant Flow|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
284230|NCT00099632|P3|Participant Flow|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
284231|NCT00099632|P2|Participant Flow|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
284232|NCT00099632|P1|Participant Flow|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
284233|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
284234|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
284235|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
284236|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
284237|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
284238|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
284239|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
284240|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
284248|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
284249|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
284250|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
284251|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
284252|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
284253|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
284254|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
284255|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
284256|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
284257|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
284258|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
284259|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
284260|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
284261|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
284262|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
284263|NCT00099632|E6|Reported Event|21-day LPV/r|SD NVP and LPV/r provided at onset of active labor, followed by 21 days of LPV/r
284264|NCT00099632|E5|Reported Event|7-day LPV/r|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
284265|NCT00099632|E4|Reported Event|21-day FTC/TDF|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF
284266|NCT00099632|E3|Reported Event|7-day FTC/TDF|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF
284267|NCT00099632|E2|Reported Event|21-day 3TC/ZDV|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV
284268|NCT00099632|E1|Reported Event|7-day 3TC/ZDV|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV
284269|NCT00099983|B3|Baseline|Total|Total of all reporting groups
284270|NCT00099983|B2|Baseline|Sugar Pill|"PTSD
Placebo : Placebo"
284271|NCT00099983|B1|Baseline|Risperidone|Risperidone : atypical antipsychotic
284272|NCT00099983|P2|Participant Flow|Sugar Pill|Placebo Sugar Pill 1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day).
284273|NCT00099983|P1|Participant Flow|Risperidone|"an atypical antipsychotic indicated for the treatment of schizophrenia but not for Post Traumatic Stress Disorder (PTSD). Some of additional unlabeled uses of risperidone include behavioral symptoms associated with dementia in the elderly, bipolar disorder, Tourette’s disorder, pervasive developmental disorder and autism.
(1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day)."
284274|NCT00099983|O2|Outcome|Sugar Pill|"Placebo 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day
Placebo: Placebo"
284275|NCT00099983|O1|Outcome|Risperidone|"1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day
Risperidone: Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time."
284276|NCT00099983|E2|Reported Event|Sugar Pill|"PTSD
Placebo : Placebo"
284277|NCT00099983|E1|Reported Event|Risperidone|Risperidone : atypical antipsychotic
284278|NCT00100048|B6|Baseline|Total|Total of all reporting groups
284279|NCT00100048|B5|Baseline|Placebo / Efavirenz 600 mg Once Daily (q.d.)|"Cohort I-Monotherapy Phase (10 Days)
Placebo to MK0518 b.i.d.
Cohort II Combined-Combination Therapy Phase (48 Weeks)
Efavirenz + Tenofovir + Lamivudine"
284280|NCT00100048|B4|Baseline|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 600 mg + tenofovir + lamivudine"
284281|NCT00100048|B3|Baseline|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 400 mg + tenofovir + lamivudine"
284282|NCT00100048|B2|Baseline|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase (10 Days)
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 200 mg + tenofovir + lamivudine"
284283|NCT00100048|B1|Baseline|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100 mg b.i.d"
284284|NCT00100048|P6|Participant Flow|Efavirenz 600 mg q.h.s.|"Cohort II Combined-Combination Therapy Phase
efavirenz 600 mg every night at bedtime (q.h.s.)"
284285|NCT00100048|P5|Participant Flow|Placebo|"Cohort I-Monotherapy Phase
Placebo to MK0518 b.i.d."
284286|NCT00100048|P4|Participant Flow|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284325|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284287|NCT00100048|P3|Participant Flow|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284288|NCT00100048|P2|Participant Flow|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284289|NCT00100048|P1|Participant Flow|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284290|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284291|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284292|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284293|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284294|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284295|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284296|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
284297|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284298|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
284299|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284300|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
284301|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284302|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
284303|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284304|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
284305|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284306|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
284307|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +
lamivudine"
284308|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284309|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284310|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284311|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284312|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +
lamivudine"
284313|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284314|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284315|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284316|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284317|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284318|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
284319|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284320|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
284321|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +
lamivudine"
284322|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284323|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284326|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284327|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
284328|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284329|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284330|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284331|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284332|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284333|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284334|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284335|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284336|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284337|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284338|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284339|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284340|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284341|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284342|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284343|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284344|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284345|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284346|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284347|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284348|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284349|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284350|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284351|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284352|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284353|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284354|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284355|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284356|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284357|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284358|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284359|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284360|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284361|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284362|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284363|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284364|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284365|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284366|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284367|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284368|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284369|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284370|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284371|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284372|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284373|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284374|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284375|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284376|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284377|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284378|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +
lamivudine"
284379|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine"
284380|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 400 mg + tenofovir + lamivudine"
284381|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine"
284382|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase
MK0518 100 mg + tenofovir + lamivudine"
284383|NCT00100048|O5|Outcome|Placebo|"Cohort I-Monotherapy Phase
Placebo to MK0518 b.i.d."
284384|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d."
284385|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d."
284386|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d"
284387|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)"
284388|NCT00100048|O5|Outcome|Placebo|"Cohort I-Monotherapy Phase
Placebo to MK0518 b.i.d."
284389|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d."
284390|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 400 mg b.i.d."
284391|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d"
284392|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase
MK0518 100 mg twice daily (b.i.d.)"
284393|NCT00100048|E2|Reported Event|Efavirenz|"EFV Combo Therapy Phase - Cohort II
efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine
This arm included participants from Cohort I who were randomized to placebo."
284394|NCT00100048|E1|Reported Event|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
284395|NCT00100178|B4|Baseline|Total|Total of all reporting groups
284396|NCT00100178|B3|Baseline|MMF-DZB Placebo Control|Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later.
284397|NCT00100178|B2|Baseline|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND saline intravenous infusions given at baseline and two weeks later
284398|NCT00100178|B1|Baseline|MMF and DZB|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later.
284399|NCT00100178|P3|Participant Flow|MMF-DZB Placebo Control|Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.
284400|NCT00100178|P2|Participant Flow|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
284401|NCT00100178|P1|Participant Flow|MMF and DZB|DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
284402|NCT00100178|O3|Outcome|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
284403|NCT00100178|O2|Outcome|Placebo Control|Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.
284431|NCT00106535|B4|Baseline|Total|Total of all reporting groups
328441|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
284404|NCT00100178|O1|Outcome|MMF and DZB|DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
284405|NCT00100178|E3|Reported Event|MMF-DZB Placebo Control|Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later.
284406|NCT00100178|E2|Reported Event|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
284407|NCT00100178|E1|Reported Event|MMF and DZB|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later .
284408|NCT00100230|B3|Baseline|Total|Total of all reporting groups
284409|NCT00100230|B2|Baseline|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
284410|NCT00100230|B1|Baseline|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
284411|NCT00100230|P2|Participant Flow|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
284412|NCT00100230|P1|Participant Flow|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
284413|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil) ARM|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight
docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
284414|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid) ARM|"Oral Docosahexaenoic acid, dosage based on body weight
docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
284415|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil)|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight
docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
284416|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid)|"Oral Docosahexaenoic acid, dosage based on body weight
docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
284417|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil)|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight
docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
284418|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid)|"Oral Docosahexaenoic acid, dosage based on body weight
docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
284419|NCT00100230|E2|Reported Event|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
284420|NCT00100230|E1|Reported Event|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
284421|NCT00106431|B1|Baseline|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
284422|NCT00106431|P1|Participant Flow|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
284423|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
284424|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
284425|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
284426|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
284427|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
284428|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
284429|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
284430|NCT00106431|E1|Reported Event|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
284433|NCT00106535|B2|Baseline|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284434|NCT00106535|B1|Baseline|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284435|NCT00106535|P4|Participant Flow|All Tocilizumab Exposure + MTX|All tocilizumab (TCZ) exposure + methotrexate (MTX) group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either Placebo, Tocilizumab 4 mg/kg or Tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received 8 mg/kg IV every 4 weeks.
284436|NCT00106535|P3|Participant Flow|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
284437|NCT00106535|P2|Participant Flow|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension (LTE) period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
284438|NCT00106535|P1|Participant Flow|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
284439|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284440|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284441|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284442|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284443|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284444|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284445|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284446|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284447|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284448|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284449|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284450|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284451|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284452|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284453|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284454|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284455|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284456|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
284457|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284458|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284459|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284460|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284461|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284462|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284463|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284464|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284465|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284466|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284467|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284468|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284469|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284470|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284471|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284472|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284473|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284474|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284475|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284476|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284477|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284478|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284479|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284480|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284481|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284482|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284483|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284484|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284485|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284486|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284487|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284488|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284489|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284490|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284491|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284492|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284493|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284494|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284495|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284496|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284497|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284498|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284499|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284500|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284501|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284502|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284503|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284504|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284505|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284506|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284507|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284508|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284509|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284510|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284511|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284512|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284513|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284514|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284515|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284516|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284517|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284518|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284519|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284520|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
328442|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
284521|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284522|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284523|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284524|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284525|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284526|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284527|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284528|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284529|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284530|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284531|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284532|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284533|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284534|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284535|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284536|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284537|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284538|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284539|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284540|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284541|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284542|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284543|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284544|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284545|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284546|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284547|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284548|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284549|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284550|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284551|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284552|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284553|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284554|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284555|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284556|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284557|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284558|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284559|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284560|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284561|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284562|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284563|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284564|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
328443|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
284565|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284566|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284567|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284568|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284569|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284570|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284571|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284572|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284573|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284574|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284575|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284576|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284577|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284578|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284579|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284580|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284581|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284582|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284583|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284584|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284585|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284586|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284587|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284588|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284589|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284590|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284591|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284592|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284593|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284594|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284595|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284596|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284597|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284598|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284599|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284600|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284601|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284602|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284603|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284604|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284605|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284606|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284607|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284608|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
286350|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
284609|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284610|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284611|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284612|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284613|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284614|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284615|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284616|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284617|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284618|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284619|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284620|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284621|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284622|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284623|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284624|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284625|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284626|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284627|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284628|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284629|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284630|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284631|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284632|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284633|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284634|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284635|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284636|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284637|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284638|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284639|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284640|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284641|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284642|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284643|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284644|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284645|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284646|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284647|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284648|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284649|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284650|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284651|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284652|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
328444|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
284653|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284654|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284655|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284656|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284657|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284658|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284659|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284660|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284661|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284662|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284663|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284664|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284665|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284666|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284667|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284668|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284669|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284670|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284671|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284672|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284673|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284674|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284675|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284676|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284677|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284678|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284679|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284680|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284681|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284682|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284683|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284684|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284685|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284686|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284687|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284688|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284689|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284690|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly
284691|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284692|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284693|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly
284694|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284695|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284696|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
286351|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
284697|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284698|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284699|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284700|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284701|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284702|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284703|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284704|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284705|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284706|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284707|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284708|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284709|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284710|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284711|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284712|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284713|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284714|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284715|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284716|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284717|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284718|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284719|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284720|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284721|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284722|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284723|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284724|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284725|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
284726|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
284727|NCT00106535|E3|Reported Event|All Tocilizumab 8 mg/kg + Methotrexate|"All participants who received tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly during the study.
Total exposure TCZ 8mg + MTX = 3797.94 PY."
284728|NCT00106535|E2|Reported Event|All Tocilizumab 4 mg/kg + Methotrexate|"All participants who received tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly during the study.
Total exposure TCZ 4mg + MTX = 580.99 PY."
284729|NCT00106535|E1|Reported Event|Placebo + Methotrexate|"Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
Total Exposure Placebo + MTX = 282.36 patient-years (PY)."
284730|NCT00106626|B5|Baseline|Total|Total of all reporting groups
284731|NCT00106626|B4|Baseline|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed
Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
284732|NCT00106626|B3|Baseline|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed
Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed
Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
284733|NCT00106626|B2|Baseline|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
284734|NCT00106626|B1|Baseline|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin
Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
284735|NCT00106626|P4|Participant Flow|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed
Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
284736|NCT00106626|P3|Participant Flow|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed
Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed
Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
284737|NCT00106626|P2|Participant Flow|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
284738|NCT00106626|P1|Participant Flow|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin
Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
284739|NCT00106626|O4|Outcome|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed
Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
284740|NCT00106626|O3|Outcome|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed
Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed
Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
284741|NCT00106626|O2|Outcome|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
284742|NCT00106626|O1|Outcome|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin
Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
284743|NCT00106626|O9|Outcome|Dose Level D.2|(Cohort D) Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed
284744|NCT00106626|O8|Outcome|Dose Level D.1|(Cohort D) Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed
284745|NCT00106626|O7|Outcome|Dose Level C.3|(Cohort C) Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed
284746|NCT00106626|O6|Outcome|Dose Level C.2|(Cohort C) Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed
284747|NCT00106626|O5|Outcome|Dose Level C.1|(Cohort C) Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed
284748|NCT00106626|O4|Outcome|Dose Level B.2|(Cohort B) Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
284749|NCT00106626|O3|Outcome|Dose Level B.1|(Cohort B) Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
284750|NCT00106626|O2|Outcome|Dose Level A.2|(Cohort A) Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin
284751|NCT00106626|O1|Outcome|Dose Level A.1|(Cohort A) Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin
284752|NCT00106639|B4|Baseline|Total|Total of all reporting groups
284753|NCT00106639|B3|Baseline|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284754|NCT00106639|B2|Baseline|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284755|NCT00106639|B1|Baseline|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284756|NCT00106639|P3|Participant Flow|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284757|NCT00106639|P2|Participant Flow|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284758|NCT00106639|P1|Participant Flow|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284759|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284760|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284761|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284762|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284763|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284764|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284765|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284766|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284767|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284768|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284769|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284770|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284771|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284772|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284773|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284774|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284775|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284776|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
328445|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
284777|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284778|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284779|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284780|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284781|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284782|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284783|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284784|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284785|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284786|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284787|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284788|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284789|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284790|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284791|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284792|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284793|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284794|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284795|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284796|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284797|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284798|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284799|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284800|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284801|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284802|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284803|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284804|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284805|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284806|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284807|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284808|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284809|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284810|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284811|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284812|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284813|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284814|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284815|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284816|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284817|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284818|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284819|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284820|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284821|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284822|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284823|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284824|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284825|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284826|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284827|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284828|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284829|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284830|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284831|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284832|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284833|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284834|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284835|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284836|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284837|NCT00106639|O1|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284838|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284839|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284840|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284841|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284842|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284843|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284844|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284845|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284846|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284847|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284848|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284849|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284850|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284851|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284852|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284853|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284854|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284855|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284856|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284857|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284858|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284859|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284860|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284861|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284862|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284863|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284864|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284865|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284866|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284867|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284868|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284869|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284870|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284871|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284872|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284873|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284874|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284875|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284876|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284877|NCT00106639|E3|Reported Event|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
284878|NCT00106639|E2|Reported Event|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
284879|NCT00106639|E1|Reported Event|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
284880|NCT00106704|B3|Baseline|Total|Total of all reporting groups
284881|NCT00106704|B2|Baseline|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
284882|NCT00106704|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
284883|NCT00106704|P2|Participant Flow|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
284884|NCT00106704|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
284885|NCT00106704|O2|Outcome|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
284886|NCT00106704|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
284887|NCT00106704|O2|Outcome|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
284888|NCT00106704|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
284889|NCT00106704|E2|Reported Event|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
284890|NCT00106704|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
284891|NCT00109343|B4|Baseline|Total|Total of all reporting groups
284892|NCT00109343|B3|Baseline|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284893|NCT00109343|B2|Baseline|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284894|NCT00109343|B1|Baseline|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284895|NCT00109343|P3|Participant Flow|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284896|NCT00109343|P2|Participant Flow|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284897|NCT00109343|P1|Participant Flow|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284898|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284899|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284900|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284901|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284902|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284903|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284904|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284905|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
285229|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
284906|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284907|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284908|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284909|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284910|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284911|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284912|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284913|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284914|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284915|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284916|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284917|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284918|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284919|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284920|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284921|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284922|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284923|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284924|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
284925|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284926|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284927|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284928|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284929|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284930|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284931|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284932|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284933|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
284934|NCT00109343|E3|Reported Event|ProQuad™ (After Dose 2)|ProQuad™ (After Dose 2) includes Days 1 to 28 after the second dose of ProQuad™ (safety follow-up period 3 for Group 1, Group 2, and Group 3).
284935|NCT00109343|E2|Reported Event|ProQuad™ Alone (After Dose 1)|ProQuad™ Alone (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 3 and safety follow-up period 2 for Group 2).
284936|NCT00109343|E1|Reported Event|ProQuad™ + Prevnar™ (After Dose 1)|ProQuad™ + Prevnar™ (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 1)
284937|NCT00109473|B3|Baseline|Total|Total of all reporting groups
284938|NCT00109473|B2|Baseline|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
284939|NCT00109473|B1|Baseline|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
284940|NCT00109473|P2|Participant Flow|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
284941|NCT00109473|P1|Participant Flow|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
284942|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
284943|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
284944|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
284945|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
284946|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
284947|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
284948|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
284949|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
284950|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
284951|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
284952|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
284953|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
284954|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
284955|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
284956|NCT00109473|E3|Reported Event|Extension Phase|Eligible subjects from both group A and group B continued on growth hormone in a 52 week extension phase
284957|NCT00109473|E2|Reported Event|Corticosteroid (CTX)|Subjects took corticosteroid as recommended by their physician
284958|NCT00109473|E1|Reported Event|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
284959|NCT00109577|B3|Baseline|Total|Total of all reporting groups
284960|NCT00109577|B2|Baseline|Micronutrient Formula|nutritional supplement
284961|NCT00109577|B1|Baseline|Placebo Comparator|Placebo comparator
284962|NCT00109577|P2|Participant Flow|Micronutrient Formula|nutritional supplement capsules containing 36-ingredients primarily vitamins and minerals; the supplement is referred to as MCN36, because it contains 36 nutrients.
284963|NCT00109577|P1|Participant Flow|Placebo Comparator|Placebo comparator capsules
284964|NCT00109577|O2|Outcome|Micronutrient Formula|nutritional supplement capsules
284965|NCT00109577|O1|Outcome|Placebo Comparator|Placebo comparator capsules
284966|NCT00109577|E2|Reported Event|Micronutrient Formula|nutritional supplement
284967|NCT00109577|E1|Reported Event|Placebo Comparator|Placebo comparator
284968|NCT00109590|B4|Baseline|Total|Total of all reporting groups
328446|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
284969|NCT00109590|B3|Baseline|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
284970|NCT00109590|B2|Baseline|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
284971|NCT00109590|B1|Baseline|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
284972|NCT00109590|P3|Participant Flow|Arm C: LPV/r x 30d|Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
284973|NCT00109590|P2|Participant Flow|Arm B : no LPV/r|Neviarpine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally once daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
284974|NCT00109590|P1|Participant Flow|Arm A : LPV/r x 7d|Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, > Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
284975|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
284976|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
284977|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
284978|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
284979|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
284980|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
284981|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
284982|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
284983|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally QD (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
284984|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
284985|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
284986|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
284987|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
284988|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
284989|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
284990|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
284991|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
284992|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
284993|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
284994|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
284995|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
284996|NCT00109590|O3|Outcome|Arm C : LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
284997|NCT00109590|O2|Outcome|Arm B: no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
284998|NCT00109590|O1|Outcome|Arm A: LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7days postpartum.
284999|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
285000|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
285001|NCT00109590|O3|Outcome|Arm C : LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
285002|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
285003|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
285004|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
285005|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
285006|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
285007|NCT00109590|E6|Reported Event|Infant: LPV/r x 30d|ZDV, ddI, LPV/r x 30d
285008|NCT00109590|E5|Reported Event|Infant: no LPV/r|ZDV & ddI x 30d
285009|NCT00109590|E4|Reported Event|Infant: LPV/r x 7d|NVP 200 mg orally, single dose at onset
285010|NCT00109590|E3|Reported Event|Mother: LPV/r x 30d|ZDV, ddI, LPV/r x 30d
285011|NCT00109590|E2|Reported Event|Mother: no LPV/r|ZDV & ddI x 30d
285012|NCT00109590|E1|Reported Event|Mother: LPV/r x 7d|NVP 200 mg orally, single dose at onset
285013|NCT00109733|B3|Baseline|Total|Total of all reporting groups
285014|NCT00109733|B2|Baseline|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
285015|NCT00109733|B1|Baseline|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
285016|NCT00109733|P2|Participant Flow|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
328447|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
285017|NCT00109733|P1|Participant Flow|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
285018|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
285019|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
285020|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
285021|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
285022|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
285023|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
285024|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
285025|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
285026|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
285027|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
285028|NCT00109733|E2|Reported Event|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
285029|NCT00109733|E1|Reported Event|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
285030|NCT00109772|B3|Baseline|Total|Total of all reporting groups
285031|NCT00109772|B2|Baseline|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285032|NCT00109772|B1|Baseline|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285033|NCT00109772|P2|Participant Flow|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285034|NCT00109772|P1|Participant Flow|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285035|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285036|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285037|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285038|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285039|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285040|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285041|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285042|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285150|NCT00110214|B2|Baseline|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
285043|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285044|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285045|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285046|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285047|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285048|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285049|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285050|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285051|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285052|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285053|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285054|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285055|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285056|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285057|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285058|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285059|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285060|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285061|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285062|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285063|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285064|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285065|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285066|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285067|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285068|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285069|NCT00109772|E2|Reported Event|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285070|NCT00109772|E1|Reported Event|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
285071|NCT00109837|B1|Baseline|Treatment|"Treatment included:
Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth"
285072|NCT00109837|P1|Participant Flow|Treatment|"Treatment included:
Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth"
285073|NCT00109837|O1|Outcome|Induction|One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.
285074|NCT00109837|O1|Outcome|Treatment|Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth
285075|NCT00109837|E4|Reported Event|Maintenance|Patient with a CR after consolidation could receive up to four courses of maintenance. Course 1 included 6-mercaptopurine and methotrexate. course 2 included vincristine, adriamycin, and dexamethasone. course 3 included cyclophosphamide, 6-thioguanine, and ara-C. course 4 included 6-mercaptopurine and methotrexate
285076|NCT00109837|E3|Reported Event|Consolidation|Patients who had a CR after induction could receive one course of consolidation therapy consisting of cyclophosphamide, ara-C, 6-mercaptopurine, G-CSF and methotrexate
285077|NCT00109837|E2|Reported Event|Second Induction|A second induction cycle with allopurinol , dexamergasone, G-CSF, high-dose ara-C and mitoxantrone
285078|NCT00109837|E1|Reported Event|First Induction|One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.
285079|NCT00109850|B1|Baseline|Treatment|Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
285080|NCT00109850|P1|Participant Flow|Treatment|Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
285081|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
285082|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
285083|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
285084|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
285085|NCT00109850|E1|Reported Event|Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
285086|NCT00109876|B1|Baseline|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
285087|NCT00109876|P1|Participant Flow|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
285088|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
285089|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
285090|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
285091|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
285092|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
285093|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
285094|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
285095|NCT00109876|E1|Reported Event|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
285096|NCT00109928|B1|Baseline|PEGS|Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.
285097|NCT00109928|P1|Participant Flow|PEGS|Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.
285098|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1 to 4, etoposide 40 mg/m2 days 1 to 4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1 to 4 of a 21 day cycle for 6 cycles.)
285099|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
285100|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
285101|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
285102|NCT00109928|E1|Reported Event|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.)
285103|NCT00109967|B3|Baseline|Total|Total of all reporting groups
285104|NCT00109967|B2|Baseline|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV"
285105|NCT00109967|B1|Baseline|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV"
285106|NCT00109967|P2|Participant Flow|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285107|NCT00109967|P1|Participant Flow|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285151|NCT00110214|B1|Baseline|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
328448|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
285108|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285109|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285110|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285111|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285112|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285113|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285114|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285115|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285116|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285217|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
285117|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m^2 Given IV
temsirolimus: 25 mg given IV"
285118|NCT00109967|E2|Reported Event|Group II: Rituximab Refractory|temsirolimus: 25 mg given IV
285119|NCT00109967|E1|Reported Event|Group I: Rituximab Sensitive|temsirolimus: 25 mg given IV
285120|NCT00110019|B3|Baseline|Total|Total of all reporting groups
285121|NCT00110019|B2|Baseline|Arm II (Carboplatin+Paclitaxel)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
285122|NCT00110019|B1|Baseline|Arm I (Carboplatin+Paclitaxel+Sorafenib)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
285123|NCT00110019|P2|Participant Flow|Arm II (Carboplatin+Paclitaxel)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
285124|NCT00110019|P1|Participant Flow|Arm I (Carboplatin+Paclitaxel+Sorafenib)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
285125|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
285126|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
285127|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
285128|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
285129|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
285130|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
285131|NCT00110019|E2|Reported Event|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
285132|NCT00110019|E1|Reported Event|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
285133|NCT00110084|B1|Baseline|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
285134|NCT00110084|P1|Participant Flow|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
285135|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
285136|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
285137|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
285138|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
285139|NCT00110084|E1|Reported Event|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
285140|NCT00110136|B1|Baseline|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day
St. John's Wort: St. John's Wort 300mg tablet three times per day"
285141|NCT00110136|P1|Participant Flow|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day
St. John's Wort: St. John's Wort 300mg tablet three times per day"
285142|NCT00110136|O1|Outcome|St. John's Wort|"Patients given one 300mg St. John's Wort tablet three times per day
St. John's Wort: St. John's Wort 300mg tablet three times per day"
285143|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day
St. John's Wort: St. John's Wort 300mg tablet three times per day"
285144|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day
St. John's Wort: St. John's Wort 300mg tablet three times per day"
285145|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day
St. John's Wort: St. John's Wort 300mg tablet three times per day"
285146|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day
St. John's Wort: St. John's Wort 300mg tablet three times per day"
285147|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day
St. John's Wort: St. John's Wort 300mg tablet three times per day"
285148|NCT00110136|E1|Reported Event|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day
St. John's Wort: St. John's Wort 300mg tablet three times per day"
285149|NCT00110214|B3|Baseline|Total|Total of all reporting groups
285152|NCT00110214|P2|Participant Flow|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
285153|NCT00110214|P1|Participant Flow|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
285154|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
285155|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
285156|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
285157|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
285158|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
285159|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
285160|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
285161|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
285162|NCT00110214|E2|Reported Event|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
285163|NCT00110214|E1|Reported Event|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
285164|NCT00110305|B5|Baseline|Total|Total of all reporting groups
285165|NCT00110305|B4|Baseline|Efavirenz|Efavirenz 600 mg once daily
285166|NCT00110305|B3|Baseline|TMC 150 mg|TMC278 150 mg once daily
285167|NCT00110305|B2|Baseline|TMC278 75 mg|TMC278 75 mg once daily
285168|NCT00110305|B1|Baseline|TMC278 25 mg|TMC278 25 mg once daily
285169|NCT00110305|P2|Participant Flow|Efavirenz|Efavirenz 600 mg once daily
285170|NCT00110305|P1|Participant Flow|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285171|NCT00110305|O4|Outcome|AUC24h Quartile 4|TMC278 25 mg, 75 mg, and 150 mg once daily
285172|NCT00110305|O3|Outcome|AUC24h Quartile 3|TMC278 25 mg, 75 mg, and 150 mg once daily
285173|NCT00110305|O2|Outcome|AUC24h Quartile 2|TMC278 25 mg, 75 mg, and 150 mg once daily
285174|NCT00110305|O1|Outcome|AUC24h Quartile 1|TMC278 25 mg, 75 mg, and 150 mg once daily
285175|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
285176|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
285177|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
285178|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
285179|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
285180|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
285181|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
285182|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285183|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
285184|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285185|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
285186|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285187|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
285188|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285189|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
285190|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
285191|NCT00110305|O1|Outcome|TMC278 25mg|TMC278 25 mg once daily
285192|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
285193|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285194|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
285195|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
285196|NCT00110305|O1|Outcome|TMC278 25mg|TMC278 25 mg once daily
285197|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
285198|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285199|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
285200|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285201|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
285202|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285203|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
285204|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285205|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
285206|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
285207|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
285208|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
285209|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285210|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
285211|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
285212|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
285213|NCT00110305|O5|Outcome|Efavirenz|Efaviren 600 mg once daily
285214|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
285215|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
285216|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
285230|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
285231|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
285232|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
285233|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
285234|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
285235|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
285236|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
285237|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
285238|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
285239|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
285240|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
285241|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
285242|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
285243|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
285244|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
285245|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
285246|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
285247|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
285248|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
285249|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
285250|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
285251|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
285252|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
285253|NCT00110357|O2|Outcome|Group B (Ages 13-18 Years)|
285254|NCT00110357|O1|Outcome|Group A (Ages 1-12 Years)|
285255|NCT00110357|O7|Outcome|Group B: 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
285256|NCT00110357|O6|Outcome|Group B: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
285257|NCT00110357|O5|Outcome|Group B: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
285258|NCT00110357|O4|Outcome|Group A: 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
285259|NCT00110357|O3|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
285260|NCT00110357|O2|Outcome|Group A: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
285261|NCT00110357|O1|Outcome|Group A: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
285262|NCT00110357|O1|Outcome|Number of Participants|
285263|NCT00110357|O2|Outcome|Non-CNS Primary Tumor|
285264|NCT00110357|O1|Outcome|CNS Primary Tumor|
285265|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285266|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285267|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285268|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
285269|NCT00110357|O2|Outcome|Group A: 150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
285270|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
285271|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285272|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285273|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285274|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
285275|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
285276|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
285277|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285278|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285279|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285280|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
285281|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
285282|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
285283|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285284|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285285|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285286|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
285287|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
285288|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
285289|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285290|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285291|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
285292|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
285293|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
285294|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
285295|NCT00110357|O7|Outcome|Group B: 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
285296|NCT00110357|O6|Outcome|Group B: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
285297|NCT00110357|O5|Outcome|Group B: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
285298|NCT00110357|O4|Outcome|Group A: 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
285299|NCT00110357|O3|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
285300|NCT00110357|O2|Outcome|Group A: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
285301|NCT00110357|O1|Outcome|Group A: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
285302|NCT00110357|E5|Reported Event|05 250 mg/m2 CET + 20 mg/m2 IRI|
285303|NCT00110357|E4|Reported Event|04 250 mg/m2 CET + 16 mg/m2 IRI|
285304|NCT00110357|E3|Reported Event|03 150 mg/m2 CET + 16 mg/m2 IRI|
285305|NCT00110357|E2|Reported Event|02 150 mg/m2 CET + 20 mg/m2 IRI|
285306|NCT00110357|E1|Reported Event|01 75 mg/m2 CET + 20 mg/m2 IRI|
285307|NCT00110396|B1|Baseline|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
285308|NCT00110396|P1|Participant Flow|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
285309|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
285310|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
285311|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
285312|NCT00110396|E1|Reported Event|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
285313|NCT00110461|B4|Baseline|Total|Total of all reporting groups
285314|NCT00110461|B3|Baseline|Placebo|Participants were given a single pill administered once daily.
285315|NCT00110461|B2|Baseline|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285316|NCT00110461|B1|Baseline|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285317|NCT00110461|P3|Participant Flow|Placebo|Participants were given a single pill administered once daily.
285318|NCT00110461|P2|Participant Flow|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285319|NCT00110461|P1|Participant Flow|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285320|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285321|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285322|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285323|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285324|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285325|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285326|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285425|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
328449|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
285327|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285328|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285329|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285330|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285331|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285332|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285333|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285334|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285335|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285336|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285337|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285338|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285339|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285340|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285341|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285342|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285343|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285344|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285345|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285346|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285347|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285348|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285349|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285350|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285426|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
285427|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
285351|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285352|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285353|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285354|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285355|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285356|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285357|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285358|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285359|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285360|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285361|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285362|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285363|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285364|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285365|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285366|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285367|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285368|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285369|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285370|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285371|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285372|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285373|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285374|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285428|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
285429|NCT00110617|E4|Reported Event|Period 2 Deferoxamine (DFO) Then ICL670|Period 2 (After 24 weeks) DFO group cross over to Deferasirox (ICL670) orally 20 mg/kg completing 52 weeks on therapy and then entering an extension period.
285375|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285376|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285377|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285378|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285379|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285380|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285381|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285382|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285383|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285384|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285385|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285386|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285387|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285388|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285389|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285390|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285391|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285392|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285393|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285394|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285395|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285396|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285397|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285398|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285430|NCT00110617|E3|Reported Event|Period 2 Deferasirox (ICL670)|Period 2 (after 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily.
285431|NCT00110617|E2|Reported Event|Period 1 Deferoxamine (DFO)|Period 1 (first 24 weeks) Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg.
285399|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285400|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285401|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285402|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285403|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285404|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285405|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285406|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285407|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
285408|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285409|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285410|NCT00110461|E3|Reported Event|Placebo|Participants were given a single pill administered once daily.
285411|NCT00110461|E2|Reported Event|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
285412|NCT00110461|E1|Reported Event|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
285413|NCT00110513|B1|Baseline|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
285414|NCT00110513|P1|Participant Flow|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
285415|NCT00110513|O1|Outcome|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level >80% and <120% of normal.
285416|NCT00110513|E1|Reported Event|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
285417|NCT00110617|B3|Baseline|Total|Total of all reporting groups
285418|NCT00110617|B2|Baseline|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
285419|NCT00110617|B1|Baseline|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
285420|NCT00110617|P2|Participant Flow|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
285421|NCT00110617|P1|Participant Flow|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
285422|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
285423|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
285424|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
285432|NCT00110617|E1|Reported Event|Period 1 Deferasirox (ICL670)|Period 1 (first 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily.
285433|NCT00110812|B4|Baseline|Total|Total of all reporting groups
285434|NCT00110812|B3|Baseline|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
285435|NCT00110812|B2|Baseline|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
285436|NCT00110812|B1|Baseline|No IL-2|Participants will receive no aldesleukin or HAART
285437|NCT00110812|P3|Participant Flow|IL-2 With Pericycle HAART|During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle). Patients did not receive aldesleukin during the extension phase.
285438|NCT00110812|P2|Participant Flow|IL-2 Without ART|During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level. Patients did not receive aldesleukin during the extension phase.
285439|NCT00110812|P1|Participant Flow|No IL-2|Participants will receive no aldesleukin or HAART during the main study or extension
285440|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
285441|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
285442|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
285443|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
285444|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
285445|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
285446|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
285447|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
285448|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
285449|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
285450|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
285451|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
285452|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
285453|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
285454|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
285455|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
285456|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
285457|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
285458|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
285459|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
285460|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
286008|NCT00114517|P4|Participant Flow|Late Postmenopause Placebo|Late postmenopause >10 years-since-menopause
285461|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
285462|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
285463|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
285464|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
285465|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
285466|NCT00110812|O1|Outcome|IL-2 With Pericycle HAART|
285467|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
285468|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
285469|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
285470|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
285471|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
285472|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
285473|NCT00110812|O2|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
285474|NCT00110812|O1|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
285475|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
285476|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
285477|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
285478|NCT00110812|E3|Reported Event|No IL-2|
285479|NCT00110812|E2|Reported Event|IL-2 Without ART|
285480|NCT00110812|E1|Reported Event|IL-2 With Pericylce HAART|
285481|NCT00110890|B3|Baseline|Total|Total of all reporting groups
285482|NCT00110890|B2|Baseline|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
285483|NCT00110890|B1|Baseline|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
285484|NCT00110890|P2|Participant Flow|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
285485|NCT00110890|P1|Participant Flow|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
285486|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
285487|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
285488|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
285489|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
286009|NCT00114517|P3|Participant Flow|Late Postmenopause 17B-estradiol|Late postmenopause >10 years-since-menopause oral 17B-estradiol 1 mg daily
285490|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
285491|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
285492|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
285493|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
285494|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
285495|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
285496|NCT00110890|E2|Reported Event|Cinacalcet|
285497|NCT00110890|E1|Reported Event|Standard Care|
285498|NCT00110994|B3|Baseline|Total|Total of all reporting groups
285499|NCT00110994|B2|Baseline|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285500|NCT00110994|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285501|NCT00110994|P2|Participant Flow|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285502|NCT00110994|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285503|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285504|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285505|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285506|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285507|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285508|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285509|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
286421|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
285510|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285511|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285512|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285513|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285514|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285515|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285516|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285517|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285518|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285519|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285520|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285521|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285522|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285523|NCT00110994|E2|Reported Event|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285524|NCT00110994|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285525|NCT00111007|B3|Baseline|Total|Total of all reporting groups
286010|NCT00114517|P2|Participant Flow|Early Postmenopause Placebo|Early postmenopause <6 years-since-menopause
285526|NCT00111007|B2|Baseline|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285527|NCT00111007|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285528|NCT00111007|P2|Participant Flow|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285529|NCT00111007|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285530|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285531|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285532|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285533|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285534|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285535|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285536|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285537|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285538|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285539|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
286011|NCT00114517|P1|Participant Flow|Early Postmenopause 17B-estradiol|Early postmenopause, <6 years-since-menopause oral 17B-estradiol 1 mg daily
286422|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
285540|NCT00111007|E2|Reported Event|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285541|NCT00111007|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
285542|NCT00111657|B1|Baseline|Single Arm - Pegloticase|
285543|NCT00111657|P1|Participant Flow|Single Arm - Pegloticase|
285544|NCT00111657|O1|Outcome|Single Arm - Pegloticase|
285545|NCT00111657|O1|Outcome|Single Arm - Pegloticase|
285546|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.
There was no control group for this open label study.
Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
285547|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.
There was no control group for this open label study.
Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
285548|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.
There was no control group for this open label study.
Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
285549|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.
There was no control group for this open label study.
Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
285550|NCT00111657|O1|Outcome|Single Arm|
285551|NCT00111657|E1|Reported Event|Single Arm - Pegloticase|
285552|NCT00111761|B3|Baseline|Total|Total of all reporting groups
285553|NCT00111761|B2|Baseline|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
285554|NCT00111761|B1|Baseline|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
285555|NCT00111761|P2|Participant Flow|Panitumumab With IFL|Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
285556|NCT00111761|P1|Participant Flow|Panitumumab With FOLFIRI|Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
285557|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
285558|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
285559|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
285560|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
285561|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
285562|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
285563|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
285564|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
285565|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
285566|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
285567|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
285568|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
285569|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
285570|NCT00111761|E2|Reported Event|Panitumumab Plus FOLFIRI|
285571|NCT00111761|E1|Reported Event|Panitumumab Plus IFL|
285572|NCT00111813|B1|Baseline|All Participants|"Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m^2, 0.9 mg/m^2, 1.1 mg/m^2, or 1.3 mg/m^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level."
285573|NCT00111813|P6|Participant Flow|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285574|NCT00111813|P5|Participant Flow|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
286012|NCT00114517|O2|Outcome|Placebo|"Matched placebo oral 17B-estradiol daily
Placebo: Matched placebo oral 17B-estradiol"
286710|NCT00107042|B2|Baseline|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
285575|NCT00111813|P4|Participant Flow|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285576|NCT00111813|P3|Participant Flow|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285577|NCT00111813|P2|Participant Flow|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285578|NCT00111813|P1|Participant Flow|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285579|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285580|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285581|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285582|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285583|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285584|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285585|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285586|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285587|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285588|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285589|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285590|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285591|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285592|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285593|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285594|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285595|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285596|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285597|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285598|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285599|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285600|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285601|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285602|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285603|NCT00111813|O1|Outcome|All Participants|"Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m^2, 0.9 mg/m^2, 1.1 mg/m^2, or 1.3 mg/m^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level."
285604|NCT00111813|E6|Reported Event|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285605|NCT00111813|E5|Reported Event|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285606|NCT00111813|E4|Reported Event|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285607|NCT00111813|E3|Reported Event|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
285608|NCT00111813|E2|Reported Event|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285609|NCT00111813|E1|Reported Event|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
285610|NCT00103610|B3|Baseline|Total|Total of all reporting groups
285611|NCT00103610|B2|Baseline|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285612|NCT00103610|B1|Baseline|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285613|NCT00103610|P2|Participant Flow|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285614|NCT00103610|P1|Participant Flow|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285615|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285616|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285617|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
286013|NCT00114517|O1|Outcome|17B-estradiol|"Oral 17B-estradiol 1 mg daily
Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
285618|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285619|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285620|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285621|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285622|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285623|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285624|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285625|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285626|NCT00103610|O1|Outcome|G-CSF + Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285627|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285628|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285629|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285630|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285631|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285632|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285633|NCT00103610|E2|Reported Event|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285634|NCT00103610|E1|Reported Event|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
285635|NCT00103662|B3|Baseline|Total|Total of all reporting groups
285636|NCT00103662|B2|Baseline|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285637|NCT00103662|B1|Baseline|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
286711|NCT00107042|B1|Baseline|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
285638|NCT00103662|P2|Participant Flow|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285639|NCT00103662|P1|Participant Flow|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285640|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285641|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285642|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285643|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285644|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285645|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285646|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285647|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285648|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285649|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285650|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285651|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285652|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285653|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285654|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285655|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285656|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
286014|NCT00114517|O2|Outcome|Placebo|"Matched placebo oral 17B-estradiol daily
Placebo: Matched placebo oral 17B-estradiol"
328450|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
285657|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285658|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285659|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285660|NCT00103662|E2|Reported Event|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285661|NCT00103662|E1|Reported Event|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
285662|NCT00103740|B3|Baseline|Total|Total of all reporting groups
285663|NCT00103740|B2|Baseline|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285664|NCT00103740|B1|Baseline|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285665|NCT00103740|P2|Participant Flow|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285666|NCT00103740|P1|Participant Flow|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285667|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285668|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285669|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285670|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285671|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285672|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285673|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285674|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285675|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285676|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285677|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
286712|NCT00107042|P2|Participant Flow|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
285678|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285679|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285680|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285681|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285682|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285683|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285684|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285685|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285686|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285687|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285688|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285689|NCT00103740|E2|Reported Event|Risedronate|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285690|NCT00103740|E1|Reported Event|Zoledronic Acid|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
285691|NCT00111917|B3|Baseline|Total|Total of all reporting groups
285692|NCT00111917|B2|Baseline|Control|CBD placed on placebo
285693|NCT00111917|B1|Baseline|Infliximab|patients who will be placed on infliximab and controls who will get placebo
285694|NCT00111917|P2|Participant Flow|Group 2 - Placebo|This group was given a placebo infusion
285695|NCT00111917|P1|Participant Flow|Group 1 - Infliximab|This group was given an infusion of inliximab
285696|NCT00111917|O2|Outcome|Group 2|Placebo received
285697|NCT00111917|O1|Outcome|Group 1|Infliximab
285698|NCT00111917|O2|Outcome|Placebo|Placebo received
285699|NCT00111917|O1|Outcome|Infliximab|Infliximab received
285700|NCT00111917|O2|Outcome|Placebo|Placebo infusion
285701|NCT00111917|O1|Outcome|Infliximab|Infliximab infusion
285702|NCT00111917|O2|Outcome|Placebo|Placebo infusion
285703|NCT00111917|O1|Outcome|Infliximab|Infliximab infusion
285704|NCT00111917|E2|Reported Event|Group 2 - Placebo|Placebo infusion received
285705|NCT00111917|E1|Reported Event|Group 1 - Infliximab|Infliximab infusion received
285706|NCT00112047|B3|Baseline|Total|Total of all reporting groups
285707|NCT00112047|B2|Baseline|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285720|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
286015|NCT00114517|O1|Outcome|17B-estradiol|"Oral 17B-estradiol 1 mg daily
Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
328451|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
285708|NCT00112047|B1|Baseline|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285709|NCT00112047|P2|Participant Flow|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285710|NCT00112047|P1|Participant Flow|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285711|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285712|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285713|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285714|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285715|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285716|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285717|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285718|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285719|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285828|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
286016|NCT00114517|O2|Outcome|Placebo|"Matched placebo oral 17B-estradiol daily
Placebo: Matched placebo oral 17B-estradiol"
285721|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285722|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285723|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285724|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285725|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285726|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285727|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285728|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285729|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285730|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285731|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285741|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285732|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285733|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285734|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
285735|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285736|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285737|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285738|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285739|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285740|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285813|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285997|NCT00114504|O2|Outcome|Simvastatin Group at 3 Month|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
328452|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
285742|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285743|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285744|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285745|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285746|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285747|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285748|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285749|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285814|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285815|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285750|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285751|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285752|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285753|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285754|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285755|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285756|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285757|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285816|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285817|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285758|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285759|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285760|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285761|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285762|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285763|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285764|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285765|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285818|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285819|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285766|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285767|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285768|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285769|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285770|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285771|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285772|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285773|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285820|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285821|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285774|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285775|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285776|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285777|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285778|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285779|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285780|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285781|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285822|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285823|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285782|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285783|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285784|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285785|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285786|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285787|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285788|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285789|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285824|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285825|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285790|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285791|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285792|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285793|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285794|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285795|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285796|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285797|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285826|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285827|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285798|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285799|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285800|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285801|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285802|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
285803|NCT00112047|E4|Reported Event|All Atripla (Week 144 to 240)|Exposure for all participants from both treatment groups who switched to ATR at Week 144 and continued treatment to Week 240 was up to 96 weeks. Exposure to ATR for 6 participants at sites in France was up to 144 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=286.
285804|NCT00112047|E3|Reported Event|CBV+EFV (Baseline to 144 Weeks)|Exposure to CBV+EFV during the randomized treatment phase was up to 144 weeks. For this safety population, N=254.
285805|NCT00112047|E2|Reported Event|FTC+TDF+EFV/ATR (Baseline to 240 Weeks)|Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase and during the Atripla treatment phase was up to 240 weeks (TVD replaced FTC+TDF at Week 96; ATR replaced TVD+EFV at Week 144). Exposure to ATR for 6 participants at sites in France was up to 288 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=160.
285806|NCT00112047|E1|Reported Event|FTC+TDF+EFV (Baseline to 144 Weeks)|Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase was up to 144 weeks (TVD replaced FTC+TDF from Week 96). For this safety population, N=257.
285807|NCT00112112|B3|Baseline|Total|Total of all reporting groups
285808|NCT00112112|B2|Baseline|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285809|NCT00112112|B1|Baseline|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285810|NCT00112112|P2|Participant Flow|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285811|NCT00112112|P1|Participant Flow|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285812|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285829|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285830|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285831|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285832|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285833|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285834|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285835|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285836|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285837|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285838|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285839|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285840|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285841|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285842|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285843|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285844|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285845|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285846|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285847|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285848|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285849|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285850|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285851|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285852|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285998|NCT00114504|O1|Outcome|Simvastatin Group Baseline|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy at baseline
285853|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285854|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285855|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285856|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285857|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285858|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285859|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285860|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285861|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285862|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285863|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285864|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285865|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285866|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285867|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285868|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285869|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285870|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285871|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285872|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285873|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285874|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285875|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285876|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285999|NCT00114504|O2|Outcome|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone or 3 months
285877|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285878|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285879|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285880|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285881|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285882|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285883|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285884|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285885|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285886|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285887|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285888|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285889|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285890|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285891|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285892|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285893|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285894|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285895|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285896|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285897|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285898|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285899|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285900|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
286000|NCT00114504|O1|Outcome|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
285901|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285902|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285903|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285904|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285905|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285906|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285907|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285908|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285909|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285910|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285911|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285912|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285913|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285914|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285915|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285916|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285917|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285918|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285919|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285920|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285921|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285922|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285923|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285924|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
286001|NCT00114504|E2|Reported Event|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
285925|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285926|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285927|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285928|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285929|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285930|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285931|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285932|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285933|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285934|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285935|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285936|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285937|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285938|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285939|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285940|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285941|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285942|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285943|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285944|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285945|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285946|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285947|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
285948|NCT00112112|E2|Reported Event|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
286002|NCT00114504|E1|Reported Event|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
285949|NCT00112112|E1|Reported Event|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
285950|NCT00112151|B7|Baseline|Total|Total of all reporting groups
285951|NCT00112151|B6|Baseline|Placebo+No Resistance Training|"Placebo group applies two 2.5 gm placebo packets
No exercise program"
285952|NCT00112151|B5|Baseline|Placebo+Resistance Training|"Placebo Group applies two 2.5 gm placebo packets
1 year standard Progressive Resistance Training(PRT) program"
285953|NCT00112151|B4|Baseline|HighT+No Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)
No exercise program"
285954|NCT00112151|B3|Baseline|HighT+Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)
1 year standard Progressive Resistance Training(PRT) program"
285955|NCT00112151|B2|Baseline|LowT+No Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)
No exercise program"
285956|NCT00112151|B1|Baseline|LowT+Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)
1 year standard Progressive Resistance Training(PRT) program"
285957|NCT00112151|P6|Participant Flow|Placebo+No Resistance Training|"Placebo group applies two 2.5 gm placebo packets
No exercise program"
285958|NCT00112151|P5|Participant Flow|Placebo+Resistance Training|"Placebo Group applies two 2.5 gm placebo packets
1 year standard Progressive Resistance Training(PRT) program"
285959|NCT00112151|P4|Participant Flow|HighT+No Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)
No exercise program"
285960|NCT00112151|P3|Participant Flow|HighT+Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)
1 year standard Progressive Resistance Training(PRT) program"
285961|NCT00112151|P2|Participant Flow|LowT+No Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)
No exercise program"
285962|NCT00112151|P1|Participant Flow|LowT+Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)
1 year standard Progressive Resistance Training(PRT) program"
285963|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
285964|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
285965|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
285966|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
285967|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
285968|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
285969|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
285970|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
285971|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
285972|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
285973|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
285974|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
285975|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
285976|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
285977|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
285978|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
285979|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
285980|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
285981|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
285982|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
285983|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower or higher-range) plus progressive resistance training
285984|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower or higher-range); no exercise
285985|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
285986|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
285987|NCT00112151|E3|Reported Event|Higher-range T|T gel supplementation targeting a total serum T concentration of 600-1000ng/dL, with our without progressive resistance training
285988|NCT00112151|E2|Reported Event|Lower-range T|T gel supplementation targeting a total serum T concentration of 400-550ng/dL, with our without progressive resistance training
285989|NCT00112151|E1|Reported Event|Placebo|Placebo gel with or without progressive resistance training
285990|NCT00114504|B3|Baseline|Total|Total of all reporting groups
285991|NCT00114504|B2|Baseline|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
285992|NCT00114504|B1|Baseline|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
285993|NCT00114504|P2|Participant Flow|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
285994|NCT00114504|P1|Participant Flow|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
285995|NCT00114504|O4|Outcome|Control Group at 3 Months|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone for 3 months.
285996|NCT00114504|O3|Outcome|Control Group Baseline|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone at baseline
286003|NCT00114517|B5|Baseline|Total|Total of all reporting groups
286017|NCT00114517|O1|Outcome|17B-estradiol|"Oral 17B-estradiol 1 mg daily
Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
286018|NCT00114517|E2|Reported Event|Placebo|"Matched placebo oral 17B-estradiol daily
Placebo: Matched placebo oral 17B-estradiol"
286019|NCT00114517|E1|Reported Event|17B-estradiol|"Oral 17B-estradiol 1 mg daily
Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
286020|NCT00114530|B3|Baseline|Total|Total of all reporting groups
286021|NCT00114530|B2|Baseline|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286022|NCT00114530|B1|Baseline|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286023|NCT00114530|P2|Participant Flow|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286024|NCT00114530|P1|Participant Flow|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286025|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286026|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286027|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286028|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286029|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286030|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286031|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286032|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286033|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286034|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286050|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286297|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|Subjects were administered oral Gleevec tablets, then tumor response was assessed
286035|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286036|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286037|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286038|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286039|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286040|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286041|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286042|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286043|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286044|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286045|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286046|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286047|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286048|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286049|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286295|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
286051|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286052|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286053|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286054|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286055|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286056|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286057|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286058|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286059|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286060|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286061|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286062|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286063|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286064|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286065|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286066|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286067|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286068|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286069|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286070|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286071|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286072|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286073|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286074|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286075|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286076|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286077|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286078|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286079|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286080|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286081|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286082|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286083|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286084|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286085|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286086|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286087|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286088|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286089|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286090|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286091|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286092|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286093|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
286094|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286095|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286096|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286097|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286098|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286099|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286100|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286101|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286102|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286103|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286104|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286105|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286106|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286107|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286108|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286109|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286110|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286111|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286112|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286113|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286114|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286115|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286116|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286117|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286118|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286144|NCT00114777|B2|Baseline|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286145|NCT00114777|B1|Baseline|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286296|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|
328453|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
286119|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286120|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286121|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286122|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286123|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286124|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286125|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286126|NCT00114530|E2|Reported Event|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
286127|NCT00114530|E1|Reported Event|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
286128|NCT00114634|B1|Baseline|Egg Yolk or no Egg Yolk|All subjects were on cholesterol suspension or egg yolk versus no egg yolk.
286129|NCT00114634|P1|Participant Flow|Egg Yolk or no Egg Yolk|This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.
286130|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
286131|NCT00114634|O1|Outcome|Placebo|egg substitute
286132|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
286133|NCT00114634|O1|Outcome|Placebo|egg substitute
286134|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
286135|NCT00114634|O1|Outcome|Placebo|egg substitute
286136|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
286137|NCT00114634|O1|Outcome|Placebo|egg substitute
286138|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
286139|NCT00114634|O1|Outcome|Placebo|egg substitute
286140|NCT00114634|O1|Outcome|Crossover Study|This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.
286141|NCT00114634|E1|Reported Event|Group 1|All subjects were on cholesterol suspension or egg yolk versus no egg yolk.
286142|NCT00114777|B4|Baseline|Total|Total of all reporting groups
286143|NCT00114777|B3|Baseline|Cyclosporin A (CsA)|Cyclosporine A 410 mg/kg was capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286146|NCT00114777|P3|Participant Flow|Cyclosporin A (CsA)|Cyclosporin A 4-10 mg/kg capsules orally in 2 divided doses, adjusted thereafter to maintain serum concentrations of 150-300 ng/mL during the first month. Subsequently, doses were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 84 months.
286147|NCT00114777|P2|Participant Flow|Belatacept Less Intensive (LI) Regimen|Belatacept 10 mg/kg intravenously on Day 1 and Day 5 during the first week, and then every other week for 4 weeks (Weeks 2 and 4), and then every 4 weeks for 2 months (Weeks 8 and 12), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months.
286148|NCT00114777|P1|Participant Flow|Belatacept More Intensive (MI) Regimen|Belatacept 10 mg/kg intravenous solution on Days 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months
286149|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286150|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286151|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286152|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286153|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286154|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286155|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286156|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286157|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286158|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286159|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286160|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286161|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286162|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286163|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286164|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286165|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286166|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286167|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286168|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286169|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286170|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286171|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286172|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286173|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286174|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286175|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286176|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286177|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286178|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286179|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286180|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286181|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286182|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286183|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84months.
286184|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286185|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286186|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286187|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286188|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286189|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286190|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286191|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286192|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286193|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286194|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286195|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286196|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286347|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
286197|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286198|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286199|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286200|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286201|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286202|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286203|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286204|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286205|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286206|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286207|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286208|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286209|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286210|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286211|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286212|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286213|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286214|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286215|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286216|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286217|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286218|NCT00114777|E3|Reported Event|Cyclosporin (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
286219|NCT00114777|E2|Reported Event|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
286220|NCT00114777|E1|Reported Event|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
286221|NCT00114959|B1|Baseline|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
286294|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
286222|NCT00114959|P1|Participant Flow|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
286223|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
286224|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
286225|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
286226|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
286227|NCT00114959|E1|Reported Event|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
286228|NCT00114972|B3|Baseline|Total|Total of all reporting groups
286229|NCT00114972|B2|Baseline|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
286230|NCT00114972|B1|Baseline|CABG|Coronary Artery By-pass Graft (CABG)
286231|NCT00114972|P2|Participant Flow|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
286232|NCT00114972|P1|Participant Flow|CABG|Coronary Artery By-pass Graft (CABG)
286233|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
286234|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
286235|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
286236|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
286237|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
286238|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
286239|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
286240|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
286241|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
286242|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
286243|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
286244|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
286245|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
286246|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
286247|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
286248|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
286249|NCT00114972|E2|Reported Event|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
286250|NCT00114972|E1|Reported Event|CABG|Coronary Artery By-pass Graft (CABG)
286251|NCT00115063|B3|Baseline|Total|Total of all reporting groups
286252|NCT00115063|B2|Baseline|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
286253|NCT00115063|B1|Baseline|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
286254|NCT00115063|P2|Participant Flow|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
286255|NCT00115063|P1|Participant Flow|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
286256|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
286257|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
286258|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
286259|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
286260|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
286261|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
286262|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
286263|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
286264|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
286265|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
286266|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
286267|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
286268|NCT00115063|E2|Reported Event|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
286269|NCT00115063|E1|Reported Event|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
286270|NCT00115297|B3|Baseline|Total|Total of all reporting groups
286271|NCT00115297|B2|Baseline|Placebo|"Placebo (placebo tablets or granules)
Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old received placebo montelukast granules."
286272|NCT00115297|B1|Baseline|Montelukast|"5-mg montelukast tablets or 4 mg granules
Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules."
286273|NCT00115297|P2|Participant Flow|Placebo|"Placebo (montelukast tablet or montelukast granules)
Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules."
286274|NCT00115297|P1|Participant Flow|Monteluksat|"5-mg montelukast tablets or 4 mg granules)
Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old will receive 4-mg montelukast granules."
286275|NCT00115297|O2|Outcome|Placebo|"Placebo (tablets or granules)
Placebo: Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
286276|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets or granules
Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
286277|NCT00115297|O2|Outcome|Placebo|"Placebo (montelukast tablets)
Placebo: Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
286278|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets
Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
286279|NCT00115297|O2|Outcome|Placebo|"Placebo (montelukast tablets)
Placebo: Participants who are 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
286280|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets
Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
286281|NCT00115297|E2|Reported Event|Placebo|"Placebo (tablets or granules)
Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules."
286282|NCT00115297|E1|Reported Event|Montelukast|"Montelukast tablets or granules
Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
286283|NCT00115349|B3|Baseline|Total|Total of all reporting groups
286284|NCT00115349|B2|Baseline|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.
Placebo Administered orally three times daily."
286285|NCT00115349|B1|Baseline|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.
L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
286286|NCT00115349|P2|Participant Flow|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.
Placebo Administered orally three times daily."
286287|NCT00115349|P1|Participant Flow|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.
L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
286288|NCT00115349|O2|Outcome|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.
Placebo Administered orally three times daily."
286289|NCT00115349|O1|Outcome|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.
L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
286290|NCT00115349|E2|Reported Event|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.
Placebo Administered orally three times daily."
286291|NCT00115349|E1|Reported Event|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.
L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
286292|NCT00115739|B1|Baseline|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
286293|NCT00115739|P1|Participant Flow|Imatinib (Gleevec) Tablets|4 (100 mg tablets) = 400 mg dose twice per day (morning and evening) for 16 weeks
286348|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
286298|NCT00115739|E1|Reported Event|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
286299|NCT00115765|B5|Baseline|Total|Total of all reporting groups
286300|NCT00115765|B4|Baseline|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286301|NCT00115765|B3|Baseline|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
286302|NCT00115765|B2|Baseline|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286303|NCT00115765|B1|Baseline|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
286304|NCT00115765|P4|Participant Flow|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286305|NCT00115765|P3|Participant Flow|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
286306|NCT00115765|P2|Participant Flow|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286307|NCT00115765|P1|Participant Flow|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
286308|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
286309|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286310|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
286311|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286312|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
286313|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286314|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
286315|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286316|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
286317|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286318|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
286319|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286320|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
286321|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286322|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
286323|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286324|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
286325|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286326|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
286327|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286328|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
286329|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286330|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
286331|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286332|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
286333|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286334|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
286335|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286336|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
286337|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286338|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
286339|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286340|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
286341|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
286342|NCT00115765|E2|Reported Event|Bevacizumab With Chemotherapy|
286343|NCT00115765|E1|Reported Event|Panit. Plus Bevacizumab With Chemotherapy|
286344|NCT00115804|B1|Baseline|Fluoxetine|All eligible patients were given fluoxetine
286345|NCT00115804|P1|Participant Flow|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
286346|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
286352|NCT00115804|O1|Outcome|Fluoxetine|"All eligible patients were started on Fluoxetine at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily.
Fluoxetine: fluoxetine po 10-60 mg/day for 12 weeks
Fluoxetine: Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily."
286353|NCT00115804|O1|Outcome|Fluoxetine|Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
286354|NCT00115804|E1|Reported Event|Fluoxetine|Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
286355|NCT00115869|B3|Baseline|Total|Total of all reporting groups
286356|NCT00115869|B2|Baseline|Social Influences School-based Smoking Prevention Curriculum|Social influences school-based smoking prevention curriculum group
286357|NCT00115869|B1|Baseline|No-intervention Control|No-intervention control group
286358|NCT00115869|P2|Participant Flow|Grade 3-12 School-based Intervention|Grade 3-12 school-influences school-based smoking prevention intervention
286359|NCT00115869|P1|Participant Flow|No-intervention Control|No-intervention control group
286360|NCT00115869|O2|Outcome|School-based Smoking Prevention Curriculum|Social influences school-based smoking prevention curriculum group
286361|NCT00115869|O1|Outcome|No-intervention Control|No-intervention control group
286362|NCT00115869|O2|Outcome|Social Influences School-based Smoking Prevention Curriculum|School-based social-influences smoking prevention curriculum condition
286363|NCT00115869|O1|Outcome|No-intervention Control|No-intervention control condition
286364|NCT00115869|E2|Reported Event|School-based Smoking Prevention Curriculum Group|school-based smoking prevention curriculum
286365|NCT00115869|E1|Reported Event|No-intervention Control Group|no-intervention control
286366|NCT00115934|B3|Baseline|Total|Total of all reporting groups
286367|NCT00115934|B2|Baseline|RVPAS|Right ventricular to pulmonary artery shunt
286368|NCT00115934|B1|Baseline|MBTS|Blalock-Taussig pulmonary artery shunt
286369|NCT00115934|P2|Participant Flow|RVPAS|Right ventricular to pulmonary artery shunt
286370|NCT00115934|P1|Participant Flow|MBTS|Blalock-Taussig pulmonary artery shunt
286371|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286372|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286373|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286374|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286375|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286376|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286377|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286378|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286379|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286380|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286381|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286382|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286383|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286384|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286385|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286386|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286387|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286388|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286389|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286390|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286391|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286392|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286393|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286394|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286395|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286396|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286397|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286398|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286399|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286400|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286401|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286402|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286403|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
286404|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
286405|NCT00115934|E2|Reported Event|RVPAS|Right ventricular to pulmonary artery shunt
286406|NCT00115934|E1|Reported Event|MBTS|Blalock-Taussig pulmonary artery shunt
286407|NCT00116168|B5|Baseline|Total|Total of all reporting groups
286408|NCT00116168|B4|Baseline|MEDI-528 9 mg|
286409|NCT00116168|B3|Baseline|MEDI-528 3 mg|
286410|NCT00116168|B2|Baseline|MEDI-528 1 mg|
286411|NCT00116168|B1|Baseline|MEDI-528 0.3 mg|
286412|NCT00116168|P4|Participant Flow|MEDI-528 9 mg|
286413|NCT00116168|P3|Participant Flow|MEDI-528 3 mg|
286414|NCT00116168|P2|Participant Flow|MEDI-528 1 mg|
286415|NCT00116168|P1|Participant Flow|MEDI-528 0.3 mg|
286416|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286417|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286418|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286419|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286420|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
328454|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
286423|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286424|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286425|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286426|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286427|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286428|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286429|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286430|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286431|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286432|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286433|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286434|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286435|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286436|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286437|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286438|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286439|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286440|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286441|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286442|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286443|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286444|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286445|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286446|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286447|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286448|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286449|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286450|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286451|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286452|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286453|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286454|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286455|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286456|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286457|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286458|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286459|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286460|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286461|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286462|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286463|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286464|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286465|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286466|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286467|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286468|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
286469|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
286470|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
286471|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
286472|NCT00116168|E4|Reported Event|MEDI-528 9 mg|
286473|NCT00116168|E3|Reported Event|MEDI-528 3 mg|
286474|NCT00116168|E2|Reported Event|MEDI-528 1 mg|
286475|NCT00116168|E1|Reported Event|MEDI-528 0.3 mg|
286476|NCT00116207|B3|Baseline|Total|Total of all reporting groups
286477|NCT00116207|B2|Baseline|Placebo|"Placebo administered twice daily.
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286478|NCT00116207|B1|Baseline|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286479|NCT00116207|P2|Participant Flow|Placebo|"Placebo administered twice daily.
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286480|NCT00116207|P1|Participant Flow|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286481|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286482|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286483|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286484|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286485|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286486|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286487|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286488|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286489|NCT00116207|E2|Reported Event|Placebo|"Placebo administered twice daily.
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286490|NCT00116207|E1|Reported Event|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
286491|NCT00116272|B3|Baseline|Total|Total of all reporting groups
286492|NCT00116272|B2|Baseline|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286493|NCT00116272|B1|Baseline|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286494|NCT00116272|P2|Participant Flow|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286495|NCT00116272|P1|Participant Flow|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286496|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286497|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286498|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286499|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286500|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286501|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286502|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286503|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286504|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286505|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286506|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286507|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286508|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286509|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286510|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286511|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286713|NCT00107042|P1|Participant Flow|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
286512|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286513|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286514|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286515|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286516|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286517|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286518|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286519|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286520|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286521|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286522|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286523|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286524|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286525|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286526|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286527|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286528|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286529|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286530|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286531|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286532|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286533|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286534|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286535|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286536|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286537|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286538|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286578|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
286539|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286540|NCT00116272|E4|Reported Event|Infants Etanercept Exposed|Infants born to pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286541|NCT00116272|E3|Reported Event|Infants Diseased Control|Infants born to pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286542|NCT00116272|E2|Reported Event|Mothers Etanercept Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
286543|NCT00116272|E1|Reported Event|Mothers Diseased Control|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
286544|NCT00116428|B3|Baseline|Total|Total of all reporting groups
286545|NCT00116428|B2|Baseline|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
286546|NCT00116428|B1|Baseline|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
286547|NCT00116428|P2|Participant Flow|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
286548|NCT00116428|P1|Participant Flow|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
286549|NCT00116428|O3|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
286550|NCT00116428|O2|Outcome|Antiarrhythmic Drug Subjects Undergoing Ablation|Control subjects underwent a study ablation procedure after failing the effectiveness endpoint.
286551|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
286552|NCT00116428|O3|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
286553|NCT00116428|O2|Outcome|Antiarrhythmic Drug Subjects Undergoing Ablation|Control Group Subjects underwent a study ablation procedure after failing the effectiveness endpoint.
286554|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
286555|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
286556|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
286557|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
286706|NCT00106964|E3|Reported Event|3. Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286558|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
286559|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
286560|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
286561|NCT00116428|E2|Reported Event|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame AND didn't undergo a study ablation procedure.
286562|NCT00116428|E1|Reported Event|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization; OR received the Catheter after failing the effectiveness endpoint. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
286563|NCT00116649|B1|Baseline|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
286564|NCT00116649|P1|Participant Flow|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
286565|NCT00116649|O1|Outcome|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
286566|NCT00116649|O1|Outcome|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
286567|NCT00116649|E1|Reported Event|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
286568|NCT00116688|B3|Baseline|Total|Total of all reporting groups
286569|NCT00116688|B2|Baseline|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
286570|NCT00116688|B1|Baseline|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
286571|NCT00116688|P2|Participant Flow|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
286572|NCT00116688|P1|Participant Flow|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
286573|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
286574|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
286575|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
286576|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
286577|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
328455|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
286579|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
286580|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
286581|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
286582|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
286583|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
286584|NCT00116688|E2|Reported Event|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
286585|NCT00116688|E1|Reported Event|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
286586|NCT00116753|B4|Baseline|Total|Total of all reporting groups
286587|NCT00116753|B3|Baseline|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
286588|NCT00116753|B2|Baseline|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
286589|NCT00116753|B1|Baseline|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
286590|NCT00116753|P3|Participant Flow|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
286591|NCT00116753|P2|Participant Flow|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
286592|NCT00116753|P1|Participant Flow|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
286593|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
286594|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
286595|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
286596|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
286597|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
286598|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
286599|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
286600|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
286601|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
286602|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
286603|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
286604|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
286605|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
286606|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
286607|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
286608|NCT00116753|E3|Reported Event|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
286609|NCT00116753|E2|Reported Event|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
286610|NCT00116753|E1|Reported Event|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
286611|NCT00106938|B3|Baseline|Total|Total of all reporting groups
286612|NCT00106938|B2|Baseline|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286613|NCT00106938|B1|Baseline|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286614|NCT00106938|P2|Participant Flow|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286615|NCT00106938|P1|Participant Flow|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286616|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286617|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286618|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286619|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286620|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286621|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286622|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286623|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286624|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286625|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286626|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286627|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286628|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286629|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286630|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286631|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286632|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286633|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286634|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286635|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286636|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286637|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286638|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286639|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286640|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286707|NCT00106964|E2|Reported Event|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286641|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286642|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286643|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286644|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286645|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286646|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286647|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286648|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286649|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286650|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286651|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286652|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286653|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286654|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286655|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286656|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286657|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286658|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286659|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286660|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286661|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286662|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286663|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286664|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286665|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286666|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286667|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286668|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286708|NCT00106964|E1|Reported Event|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286669|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286670|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286671|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286672|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286673|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286674|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286675|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286676|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286677|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286678|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286679|NCT00106938|E2|Reported Event|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286680|NCT00106938|E1|Reported Event|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
286681|NCT00106964|B4|Baseline|Total|Total of all reporting groups
286682|NCT00106964|B3|Baseline|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286683|NCT00106964|B2|Baseline|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286684|NCT00106964|B1|Baseline|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286685|NCT00106964|P3|Participant Flow|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286686|NCT00106964|P2|Participant Flow|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286687|NCT00106964|P1|Participant Flow|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286688|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286689|NCT00106964|O2|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286690|NCT00106964|O1|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286691|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286692|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286693|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286694|NCT00106964|O3|Outcome|3: Twindrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286695|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286696|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286697|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|Twinrix 20 mcg vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
286698|NCT00106964|O2|Outcome|2: Engerix 40 mcg|Engerix 40 mcg vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
286699|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
286700|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|Twinrix 20 mcg vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
286701|NCT00106964|O2|Outcome|2: Engerix 40 mcg|Engerix 40 mcg vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
286702|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
286703|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286704|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286705|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
286709|NCT00107042|B3|Baseline|Total|Total of all reporting groups
286714|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286715|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
286716|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286717|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
286718|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286719|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286720|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286721|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286722|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
286723|NCT00107042|O2|Outcome|Ever Used Drugs Not Prescribed: YES|Subjects who have used drugs that were not prescribed.
286724|NCT00107042|O1|Outcome|Ever Used Drugs Not Prescribed: NO|Subjects who have never used drugs that were not prescribed.
286725|NCT00107042|O2|Outcome|Ever Smoked Marijuana: YES|Subjects who have smoked marijuana
286726|NCT00107042|O1|Outcome|Ever Smoked Marijuana: NO|Subjects who have never smoked marijuana
286727|NCT00107042|O2|Outcome|Ever Drank Alcohol: YES|Subjects who have drank alcohol
286728|NCT00107042|O1|Outcome|Ever Drank Alcohol: NO|Subjects who have never drank alcohol
286729|NCT00107042|O3|Outcome|>= 6 Female Sex Partners|Male and female subjects who have had 6 or more lifetime female sex partners
286730|NCT00107042|O2|Outcome|1-5 Female Sex Partners|Male and female Subjects who have had 1 - 5 lifetime female sex partners
286731|NCT00107042|O1|Outcome|0 Female Sex Partners|Male and female subjects who have never had a female sex partner
286732|NCT00107042|O3|Outcome|>= 6 Male Sex Partners|Male and female subjects who have had 6 or more lifetime male sex partners
286733|NCT00107042|O2|Outcome|1-5 Male Sex Partners|Male and female subjects who have had 1 - 5 lifetime male sex partners
286734|NCT00107042|O1|Outcome|0 Male Sex Partners|Male and female subjects who have never had a male sex partner
286735|NCT00107042|O3|Outcome|>= 6 Sex Partners|Subjects who have had 6 or more lifetime sex partners
286736|NCT00107042|O2|Outcome|1 - 5 Sex Partners|Subjects who have had 1 - 5 lifetime sex partners
286737|NCT00107042|O1|Outcome|0 Sex Partners|Subjects who have never had a sex partner
286738|NCT00107042|O3|Outcome|15-17 Years of Age|Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 15 and 17, inclusive
286739|NCT00107042|O2|Outcome|12-14 Years of Age|Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 12 and 14, inclusive
286740|NCT00107042|O1|Outcome|Never|Subjects who reported they never had anal or vaginal sex because they wanted to.
286741|NCT00107042|O2|Outcome|Gay (Homosexual), Bi (Bisexual), Not Sure or Undecided|Subjects who were either gay (homosexual), bisexual, not sure or undecided.
286742|NCT00107042|O1|Outcome|Straight (Heterosexual)|Subjects who were straight (heterosexual)
286743|NCT00107042|O2|Outcome|Ever Smoked Cigarettes: YES|Subjects who have smoked cigarettes
286744|NCT00107042|O1|Outcome|Ever Smoked Cigarettes: NO|Subjects who have never smoked cigarettes
286745|NCT00107042|O2|Outcome|Overweight and Obese (>=25.0)|Subjects whose BMIs were >= 25.0
286746|NCT00107042|O1|Outcome|Normal and Underweight (< 25.0)|Subjects whose BMIs were normal to < 25.0
286747|NCT00107042|O2|Outcome|Tanner Stages 1-4 (Males)|Males who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
286748|NCT00107042|O1|Outcome|Tanner Stage 5 (Males)|Males who were self-assessed and categorized to Tanner Stage 5.
286749|NCT00107042|O2|Outcome|Tanner Stages 1-4 (Females)|Females who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
286750|NCT00107042|O1|Outcome|Tanner Stage 5 (Females)|Females who were self-assessed and categorized to Tanner Stage 5.
286751|NCT00107042|O3|Outcome|Black/African American|Subjects who reported their race to be black or African American
286752|NCT00107042|O2|Outcome|Other/Mixed Race|Subjects who reported their race to be other than white, black, or of mixed race.
286753|NCT00107042|O1|Outcome|White|Subjects who reported their race to be white.
286754|NCT00107042|O2|Outcome|Hispanic|Subjects who reported they were of Hispanic ethnicity.
286755|NCT00107042|O1|Outcome|Not Hispanic|Subjects who reported they were not of Hispanic ethnicity.
286756|NCT00107042|O2|Outcome|Male|Male Subjects
286757|NCT00107042|O1|Outcome|Female|Female Subjects
286758|NCT00107042|O2|Outcome|12-14 Years of Age|Subjects between the ages of 12 and 14 years, inclusive
286759|NCT00107042|O1|Outcome|15-17 Years of Age|Subjects between the ages of 15 and 17 years, inclusive
286760|NCT00107042|O2|Outcome|Baltimore|Clinical site where subjects were enrolled.
286761|NCT00107042|O1|Outcome|Other Sites|All other clinical sites (besides the Baltimore site) where subjects were enrolled.
286762|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286763|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Wk 24
286764|NCT00107042|O1|Outcome|All Participants|All participants who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (per protocol). Participants were vaccinated at Week 0 and Week 24 with either Recombivax or Twinrix.
286765|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286766|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
286767|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286768|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
286769|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286770|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
286771|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286772|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
286773|NCT00107042|E2|Reported Event|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
286774|NCT00107042|E1|Reported Event|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
286775|NCT00107120|B3|Baseline|Total|Total of all reporting groups
286776|NCT00107120|B2|Baseline|Placebo|Once daily oral administration of placebo tablets
286777|NCT00107120|B1|Baseline|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
286778|NCT00107120|P2|Participant Flow|Placebo|Once daily oral administration of placebo tablets
286779|NCT00107120|P1|Participant Flow|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
286780|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
286781|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
286782|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
286783|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
286784|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
286785|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
286786|NCT00107120|E2|Reported Event|Placebo|Once daily oral administration of placebo tablets
286787|NCT00107120|E1|Reported Event|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
286788|NCT00107172|B3|Baseline|Total|Total of all reporting groups
286789|NCT00107172|B2|Baseline|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286790|NCT00107172|B1|Baseline|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286791|NCT00107172|P2|Participant Flow|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286792|NCT00107172|P1|Participant Flow|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286793|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286794|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286795|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286796|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286797|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286798|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286799|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286800|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286801|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286802|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286803|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286804|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286805|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286806|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286807|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286808|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286809|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286810|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286811|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286812|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286813|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286814|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286815|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286816|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286817|NCT00107172|E2|Reported Event|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
286818|NCT00107172|E1|Reported Event|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
286950|NCT00107900|P6|Participant Flow|120mg QD|120mg edoxaban administered once daily (QD)
286951|NCT00107900|P5|Participant Flow|60mg BID|60mg edoxaban administered twice daily (BID)
286819|NCT00107198|B1|Baseline|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT"
286820|NCT00107198|P1|Participant Flow|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT"
286821|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT"
286822|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT"
286823|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT"
286824|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT"
286825|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT"
286848|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate
laboratory biomarker analysis: Correlative studies"
286849|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate
laboratory biomarker analysis: Correlative studies"
286850|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate
laboratory biomarker analysis: Correlative studies"
286826|NCT00107198|E1|Reported Event|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
doxorubicin hydrochloride: Given IV
conventional surgery: Undergo surgery
cyclophosphamide: Given IV
prednisone: Given IV or PO
vincristine sulfate: Given IV
radiation therapy: Undergo IFRT"
286827|NCT00107276|B1|Baseline|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
286828|NCT00107276|P1|Participant Flow|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
286829|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|
286830|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
286831|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
286832|NCT00107276|E1|Reported Event|Cyclophosphamide and Capecitabine|
286833|NCT00107315|B1|Baseline|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
286834|NCT00107315|P1|Participant Flow|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
286835|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
286836|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
286837|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
286838|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
286839|NCT00107315|E1|Reported Event|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
286840|NCT00107380|B1|Baseline|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
286841|NCT00107380|P1|Participant Flow|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
286842|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
286843|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
286844|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
286845|NCT00107380|E1|Reported Event|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
286846|NCT00107536|B1|Baseline|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate
laboratory biomarker analysis: Correlative studies"
286847|NCT00107536|P1|Participant Flow|Lapatinib|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate
laboratory biomarker analysis: Correlative studies"
286942|NCT00107783|E1|Reported Event|Control|No treatment
286851|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate
laboratory biomarker analysis: Correlative studies"
286852|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate
laboratory biomarker analysis: Correlative studies"
286853|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate
laboratory biomarker analysis: Correlative studies"
286854|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate
laboratory biomarker analysis: Correlative studies"
286855|NCT00107536|E1|Reported Event|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate
laboratory biomarker analysis: Correlative studies"
286856|NCT00107575|B3|Baseline|Total|Total of all reporting groups
286857|NCT00107575|B2|Baseline|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
286858|NCT00107575|B1|Baseline|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
286859|NCT00107575|P2|Participant Flow|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
286860|NCT00107575|P1|Participant Flow|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
286861|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
286862|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
286863|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
286864|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
286865|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
286866|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
286867|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
286868|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
286869|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
286870|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
286871|NCT00107575|E2|Reported Event|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
286872|NCT00107575|E1|Reported Event|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
286873|NCT00107614|B1|Baseline|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
286874|NCT00107614|P1|Participant Flow|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
286875|NCT00107614|O1|Outcome|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
286876|NCT00107614|E1|Reported Event|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
286877|NCT00107653|B3|Baseline|Total|Total of all reporting groups
286878|NCT00107653|B2|Baseline|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286879|NCT00107653|B1|Baseline|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286880|NCT00107653|P2|Participant Flow|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286943|NCT00107900|B7|Baseline|Total|Total of all reporting groups
328456|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
286881|NCT00107653|P1|Participant Flow|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286882|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286883|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286884|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286885|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286886|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286887|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286888|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286889|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286890|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286891|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286892|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286893|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286894|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286895|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286896|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286944|NCT00107900|B6|Baseline|120mg QD|120mg edoxaban administered once daily (QD)
286945|NCT00107900|B5|Baseline|60mg BID|60mg edoxaban administered twice daily (BID)
286946|NCT00107900|B4|Baseline|60mg QD|60mg edoxaban administered once daily (QD)
286897|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286898|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286899|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286900|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286901|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286902|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286903|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286904|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286905|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286906|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286907|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286908|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286909|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286910|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286911|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286912|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286947|NCT00107900|B3|Baseline|30mg BID|30mg edoxaban administered twice daily (BID)
286948|NCT00107900|B2|Baseline|30mg QD|30mg edoxaban administered once daily (QD)
286949|NCT00107900|B1|Baseline|15mg BID|15mg edoxaban administered twice daily (BID)
286913|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286914|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286915|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286916|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286917|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286918|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286919|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286920|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286921|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286922|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286923|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286924|NCT00107653|E2|Reported Event|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
286925|NCT00107653|E1|Reported Event|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
286926|NCT00107783|B3|Baseline|Total|Total of all reporting groups
286927|NCT00107783|B2|Baseline|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
286928|NCT00107783|B1|Baseline|Control|No treatment
286929|NCT00107783|P2|Participant Flow|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
286930|NCT00107783|P1|Participant Flow|Control|No treatment
286931|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
286932|NCT00107783|O1|Outcome|Control|No treatment
286933|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
286934|NCT00107783|O1|Outcome|Control|No treatment
286935|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
286936|NCT00107783|O1|Outcome|Control|No treatment
286937|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
286938|NCT00107783|O1|Outcome|Control|No treatment
286939|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
286940|NCT00107783|O1|Outcome|Control|No treatment
286941|NCT00107783|E2|Reported Event|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
286952|NCT00107900|P4|Participant Flow|60mg QD|60mg edoxaban administered once daily (QD)
286953|NCT00107900|P3|Participant Flow|30mg BID|30mg edoxaban administered twice daily (BID)
286954|NCT00107900|P2|Participant Flow|30mg QD|30mg edoxaban administered once daily (QD)
286955|NCT00107900|P1|Participant Flow|15mg BID|15mg edoxaban administered twice daily (BID)
286956|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
286957|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
286958|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
286959|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
286960|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
286961|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
286962|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
286963|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
286964|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
286965|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
286966|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
286967|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
286968|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
286969|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
286970|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
286971|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
286972|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
286973|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
286974|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
286975|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
286976|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
286977|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
286978|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
286979|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
286980|NCT00107900|E6|Reported Event|120mg QD|120mg edoxaban administered once daily (QD)
286981|NCT00107900|E5|Reported Event|60mg BID|60mg edoxaban administered twice daily (BID)
286982|NCT00107900|E4|Reported Event|60mg QD|60mg edoxaban administered once daily (QD)
286983|NCT00107900|E3|Reported Event|30mg BID|30mg edoxaban administered twice daily (BID)
286984|NCT00107900|E2|Reported Event|30mg QD|30mg edoxaban administered once daily (QD)
286985|NCT00107900|E1|Reported Event|15mg BID|15mg edoxaban administered twice daily (BID)
286986|NCT00107952|B3|Baseline|Total|Total of all reporting groups
286987|NCT00107952|B2|Baseline|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
286988|NCT00107952|B1|Baseline|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
286989|NCT00107952|P2|Participant Flow|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
286990|NCT00107952|P1|Participant Flow|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
286991|NCT00107952|O2|Outcome|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
286992|NCT00107952|O1|Outcome|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
286993|NCT00107952|E2|Reported Event|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
286994|NCT00107952|E1|Reported Event|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
286995|NCT00107978|B3|Baseline|Total|Total of all reporting groups
286996|NCT00107978|B2|Baseline|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
286997|NCT00107978|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
286998|NCT00107978|P2|Participant Flow|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
286999|NCT00107978|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
287000|NCT00107978|O2|Outcome|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
287001|NCT00107978|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
287002|NCT00107978|E2|Reported Event|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
287520|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287003|NCT00107978|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
287004|NCT00107991|B1|Baseline|Etanercept|50 mg/week subcutaneously
287005|NCT00107991|P1|Participant Flow|Etanercept|50 mg/week subcutaneously
287006|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
287007|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
287008|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
287009|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
287010|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
287011|NCT00107991|E1|Reported Event|Etanercept|50 mg/week subcutaneously
287012|NCT00108069|B3|Baseline|Total|Total of all reporting groups
287013|NCT00108069|B2|Baseline|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day"
287014|NCT00108069|B1|Baseline|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day"
287015|NCT00108069|P2|Participant Flow|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day"
287016|NCT00108069|P1|Participant Flow|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day"
287017|NCT00108069|O6|Outcome|Total|Total number of participants.
287018|NCT00108069|O5|Outcome|Grade 5|Death related to adverse event
287019|NCT00108069|O4|Outcome|Grade 4|Life-threatening or disabling adverse event
287020|NCT00108069|O3|Outcome|Grade 3|Severe adverse event
287021|NCT00108069|O2|Outcome|Grade 2|Moderate adverse event
287022|NCT00108069|O1|Outcome|Grade 1|Mild adverse event
287023|NCT00108069|O2|Outcome|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day"
287024|NCT00108069|O1|Outcome|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day"
287025|NCT00108069|O2|Outcome|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day"
287026|NCT00108069|O1|Outcome|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day"
287027|NCT00108069|E2|Reported Event|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day"
287028|NCT00108069|E1|Reported Event|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
Tamoxifen citrate : oral dose 120 mg twice a day, every day"
287029|NCT00108082|B4|Baseline|Total|Total of all reporting groups
287030|NCT00108082|B3|Baseline|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287031|NCT00108082|B2|Baseline|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287032|NCT00108082|B1|Baseline|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287033|NCT00108082|P3|Participant Flow|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287034|NCT00108082|P2|Participant Flow|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287035|NCT00108082|P1|Participant Flow|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287036|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287037|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287038|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287039|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287521|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287040|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287041|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287042|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287043|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287044|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287045|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287046|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287047|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287048|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287049|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287050|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287051|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287052|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287053|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287054|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287055|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287056|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287057|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287058|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287059|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287060|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287061|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287087|NCT00108160|O1|Outcome|Mupirocin Ointment [Treatment]|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
287522|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287062|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287063|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287064|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287065|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287066|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287067|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287068|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287069|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287070|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287071|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287072|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287073|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287074|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287075|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287076|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287077|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287078|NCT00108082|E3|Reported Event|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287079|NCT00108082|E2|Reported Event|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
287080|NCT00108082|E1|Reported Event|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
287081|NCT00108160|B3|Baseline|Total|Total of all reporting groups
287082|NCT00108160|B2|Baseline|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Placebo Group).
287083|NCT00108160|B1|Baseline|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Treatment Group).
287084|NCT00108160|P2|Participant Flow|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
287085|NCT00108160|P1|Participant Flow|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
287086|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment [Placebo]|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
287088|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
287089|NCT00108160|O1|Outcome|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
287090|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
287091|NCT00108160|O1|Outcome|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
287092|NCT00108160|E2|Reported Event|Polyethylene Glycol Ointment|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
287093|NCT00108160|E1|Reported Event|Mupirocin Ointment|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
287094|NCT00108277|B4|Baseline|Total|Total of all reporting groups
287095|NCT00108277|B3|Baseline|Waitlist|"Waitlist
Treatment as usual"
287096|NCT00108277|B2|Baseline|Lower CO2|"Lower CO2
Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2"
287097|NCT00108277|B1|Baseline|Raise CO2|"Raise CO2
Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2"
287098|NCT00108277|P3|Participant Flow|Waitlist|Waitlist Treatment as Usual
287099|NCT00108277|P2|Participant Flow|Lower CO2|"Lower CO2
Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2"
287100|NCT00108277|P1|Participant Flow|Raise CO2|"Raise CO2
Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2"
287101|NCT00108277|O3|Outcome|Waitlist|Waitlist Treatment as usual
287102|NCT00108277|O2|Outcome|Lower CO2|"Lower CO2
Breathing Training- Lower CO2: while breathing 9 breaths per minute, patients are instructed to lower CO2"
287103|NCT00108277|O1|Outcome|Raise CO2|"Raise CO2
Breathing Training-Raise CO2: while breathing 9 breaths per minute, patients are instructed to raise CO2"
287104|NCT00108277|E3|Reported Event|Waitlist|Treatment as usual
287105|NCT00108277|E2|Reported Event|Lower CO2|Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2
287106|NCT00108277|E1|Reported Event|Raise CO2|Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2
287107|NCT00108303|B4|Baseline|Total|Total of all reporting groups
287108|NCT00108303|B3|Baseline|Controls|Persons who are not related to persons in Arm 2 and do not have schizophrenia themselves.
287109|NCT00108303|B2|Baseline|Schizophrenia Relatives|Persons who are first degree relatives of persons in Arm 1
287110|NCT00108303|B1|Baseline|Schizophrenia Probands|Persons who meet DSM-IV criteria for schizophrenia or schizoaffective disorder
287111|NCT00108303|P3|Participant Flow|Controls|Subjects who are unrelated to persons with schizophrenia and do not fulfill criteria for schizophrenia themselves.
287112|NCT00108303|P2|Participant Flow|Schizophrenia Relatives|Subjects who are first degree relatives of subjects in Arm 1.
287113|NCT00108303|P1|Participant Flow|Schizophrenia Probands|Persons who meet DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder.
287114|NCT00108303|O3|Outcome|Controls|Persons who are not relatives of persons with schizophrenia and do not have schizophrenia themselves.
287115|NCT00108303|O2|Outcome|Schizophrenia Relatives|Persons who are relatives of probands in Group 1.
287116|NCT00108303|O1|Outcome|Schizophrenia Probands|Persons who meet DSM-IV diagnostic criteria for schizophrenia.
287117|NCT00108303|O3|Outcome|Controls|Persons who do not have schizophrenia themselves and whose relatives do not have schizophrenia
287118|NCT00108303|O2|Outcome|Schizophrenia Relatives|Persons who are siblings or children of someone with schizophrenia
287119|NCT00108303|O1|Outcome|Schizophrenia Probands|Persons who have schizophrenia as determined by diagnosis
287120|NCT00108303|O1|Outcome|Group 1|Subjects who receive genetic study.
287121|NCT00108303|E3|Reported Event|Controls|Controls who do not have personal or family history of schizophrenia
287122|NCT00108303|E2|Reported Event|Schizophrenia Relatives|Schizophrenia relatives who siblings or children of persons with schizophrenia
287123|NCT00108303|E1|Reported Event|Schizophrenia Probands|Schizophrenia probands as diagnosed as having schizophrenia
287124|NCT00108342|B3|Baseline|Total|Total of all reporting groups
287125|NCT00108342|B2|Baseline|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
287126|NCT00108342|B1|Baseline|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
Nicotine gum - 2 mg and 4 mg
Nicotine lozenges - 2 mg and 4 mg
Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
287127|NCT00108342|P2|Participant Flow|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
287128|NCT00108342|P1|Participant Flow|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
Nicotine gum - 2 mg and 4 mg
Nicotine lozenges - 2 mg and 4 mg
Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
287129|NCT00108342|O2|Outcome|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
287130|NCT00108342|O1|Outcome|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
Nicotine gum - 2 mg and 4 mg
Nicotine lozenges - 2 mg and 4 mg
Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
287131|NCT00108342|E2|Reported Event|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
287132|NCT00108342|E1|Reported Event|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
Nicotine gum - 2 mg and 4 mg
Nicotine lozenges - 2 mg and 4 mg
Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
287133|NCT00108355|B3|Baseline|Total|Total of all reporting groups
287523|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287134|NCT00108355|B2|Baseline|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
287135|NCT00108355|B1|Baseline|Albumin (Control Group)|"After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
287136|NCT00108355|P2|Participant Flow|Vasoconstrictors (Study Group)|"After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
287137|NCT00108355|P1|Participant Flow|Albumin (Control Group)|"After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
287138|NCT00108355|O2|Outcome|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
287139|NCT00108355|O1|Outcome|Albumin (Control Group)|"After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
287140|NCT00108355|O2|Outcome|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
287141|NCT00108355|O1|Outcome|Albumin (Control Group)|"After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
287142|NCT00108355|E2|Reported Event|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
287143|NCT00108355|E1|Reported Event|Albumin (Control Group)|"After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
287144|NCT00108433|B3|Baseline|Total|Total of all reporting groups
287145|NCT00108433|B2|Baseline|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
287146|NCT00108433|B1|Baseline|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
287147|NCT00108433|P2|Participant Flow|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
287148|NCT00108433|P1|Participant Flow|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
287149|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
287150|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
287151|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
287152|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
287153|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
287154|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
287155|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
287156|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
287157|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
287158|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
287159|NCT00108433|E2|Reported Event|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
287160|NCT00108433|E1|Reported Event|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
287161|NCT00108485|B3|Baseline|Total|Total of all reporting groups
287162|NCT00108485|B2|Baseline|Placebo|Placebo tablets
287163|NCT00108485|B1|Baseline|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator
Extended release niacin: Extended release niacin 1500-2000mg once daily"
287164|NCT00108485|P2|Participant Flow|Placebo|Placebo tablets
287165|NCT00108485|P1|Participant Flow|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator
Extended release niacin: Extended release niacin 1500-2000mg once daily"
287166|NCT00108485|O2|Outcome|Placebo|Placebo tablets
287167|NCT00108485|O1|Outcome|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator
Extended release niacin: Extended release niacin 1500-2000mg once daily"
287168|NCT00108485|E2|Reported Event|Placebo|Placebo tablets
287169|NCT00108485|E1|Reported Event|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator
Extended release niacin: Extended release niacin 1500-2000mg once daily"
287170|NCT00108524|B3|Baseline|Total|Total of all reporting groups
287171|NCT00108524|B2|Baseline|Arm 2|"Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (<30% of daily energy), saturated fat (<10% of daily energy), cholesterol (<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly."
287172|NCT00108524|B1|Baseline|Arm 1|"Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished."
287200|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287173|NCT00108524|P2|Participant Flow|Low-Fat Diet Plus Orlistat|"Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (<30% of daily energy), saturated fat (<10% of daily energy), cholesterol (<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly."
287174|NCT00108524|P1|Participant Flow|Low Carbohydrate Ketogenic Diet|"Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished."
287175|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
287176|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
287177|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
287178|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
287179|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
287180|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
287181|NCT00108524|E2|Reported Event|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
287182|NCT00108524|E1|Reported Event|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
287183|NCT00108550|B3|Baseline|Total|Total of all reporting groups
287184|NCT00108550|B2|Baseline|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
287185|NCT00108550|B1|Baseline|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
287186|NCT00108550|P2|Participant Flow|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
287187|NCT00108550|P1|Participant Flow|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
287188|NCT00108550|O2|Outcome|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
287189|NCT00108550|O1|Outcome|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
287190|NCT00108550|O2|Outcome|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
287191|NCT00108550|O1|Outcome|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
287192|NCT00108550|E2|Reported Event|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
287193|NCT00108550|E1|Reported Event|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
287194|NCT00108628|B3|Baseline|Total|Total of all reporting groups
287195|NCT00108628|B2|Baseline|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287196|NCT00108628|B1|Baseline|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287197|NCT00108628|P2|Participant Flow|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287198|NCT00108628|P1|Participant Flow|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287199|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287201|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287202|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287203|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287204|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287205|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287206|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287207|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287208|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287209|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287210|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287211|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287212|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287213|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287285|NCT00109005|P2|Participant Flow|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
287214|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287215|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287216|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287217|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287218|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287219|NCT00108628|E2|Reported Event|Sleep and Nightmare Management|"Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
287220|NCT00108628|E1|Reported Event|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
287221|NCT00108732|B1|Baseline|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.
Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
287222|NCT00108732|P1|Participant Flow|Vaccinia/Fowlpox/GM-CSF|"There are two steps in this study. Patients receive vaccine treatment in Step 1. Patients with biochemical or clinical progression during Step 1 were eligible to continue on to androgen blockade in Step 2. This report includes information collected in Step 1 only.
Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.
Patients with biochemical or clinical disease progression may start Step II androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
287223|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.
Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
287224|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.
Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
287286|NCT00109005|P1|Participant Flow|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
287287|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
287524|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
328457|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
287225|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.
Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
287226|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.
Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
287227|NCT00108732|E1|Reported Event|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.
Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
287228|NCT00108862|B3|Baseline|Total|Total of all reporting groups
287229|NCT00108862|B2|Baseline|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287230|NCT00108862|B1|Baseline|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287231|NCT00108862|P2|Participant Flow|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287232|NCT00108862|P1|Participant Flow|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287233|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287288|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
287289|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
287290|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
287525|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287234|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287235|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287236|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287237|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287238|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287239|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287240|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287241|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287291|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
287292|NCT00109005|O2|Outcome|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
287242|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287243|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287244|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287245|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287246|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287247|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287248|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287249|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287293|NCT00109005|O1|Outcome|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
287294|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
287250|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287251|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287252|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287253|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287254|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287255|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287256|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287257|NCT00108862|E2|Reported Event|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
287295|NCT00109005|E2|Reported Event|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
287296|NCT00109005|E1|Reported Event|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
287258|NCT00108862|E1|Reported Event|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
287259|NCT00108953|B3|Baseline|Total|Total of all reporting groups
287260|NCT00108953|B2|Baseline|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287261|NCT00108953|B1|Baseline|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287262|NCT00108953|P2|Participant Flow|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287263|NCT00108953|P1|Participant Flow|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287264|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287265|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287266|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287267|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287268|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287269|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287270|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287271|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287272|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287273|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287274|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287275|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287276|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287277|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287278|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287279|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287280|NCT00108953|E2|Reported Event|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287281|NCT00108953|E1|Reported Event|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
287282|NCT00109005|B3|Baseline|Total|Total of all reporting groups
287283|NCT00109005|B2|Baseline|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
287284|NCT00109005|B1|Baseline|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
287298|NCT00109031|B4|Baseline|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287299|NCT00109031|B3|Baseline|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287300|NCT00109031|B2|Baseline|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287301|NCT00109031|B1|Baseline|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
287302|NCT00109031|P4|Participant Flow|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
287303|NCT00109031|P3|Participant Flow|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
287304|NCT00109031|P2|Participant Flow|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and matched placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
287305|NCT00109031|P1|Participant Flow|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
287306|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287307|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287308|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287309|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
287310|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287311|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287312|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287313|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
287314|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287315|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287316|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287317|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
287318|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287319|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287320|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287321|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
287322|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287323|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287324|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287325|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
287326|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287327|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287328|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287329|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
287330|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287331|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287332|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287333|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
287334|NCT00109031|E4|Reported Event|Palifermin 180 μg/kg on Day −3 (D)|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287335|NCT00109031|E3|Reported Event|Palifermin 180 μg/kg on Day −2 (C)|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287336|NCT00109031|E2|Reported Event|Palifermin 180 μg/kg on Day −1 (B)|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
287337|NCT00109031|E1|Reported Event|Palifermin 60 µg/kg for 3 Days (A)|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
287338|NCT00116779|B3|Baseline|Total|Total of all reporting groups
287339|NCT00116779|B2|Baseline|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287340|NCT00116779|B1|Baseline|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287341|NCT00116779|P2|Participant Flow|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287342|NCT00116779|P1|Participant Flow|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287343|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287344|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287345|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287346|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287347|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287348|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287349|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287350|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287351|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287352|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287353|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287354|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287355|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287356|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287357|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
328458|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
287358|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287359|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287360|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287361|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287362|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287363|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287364|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287365|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287366|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287367|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287368|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287369|NCT00116779|E2|Reported Event|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
287370|NCT00116779|E1|Reported Event|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
287371|NCT00116805|B3|Baseline|Total|Total of all reporting groups
287372|NCT00116805|B2|Baseline|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287373|NCT00116805|B1|Baseline|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287374|NCT00116805|P2|Participant Flow|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287375|NCT00116805|P1|Participant Flow|TDF-TDF|Tenofovir disoproxil fumarate (TDF) 300 mg plus placebo to match adefovir dipivoxil (ADV) (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet) in the open-label period.
287376|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287377|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287378|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287379|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287380|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287381|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287382|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287383|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287384|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287526|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
328459|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
287385|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287386|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287387|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287388|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287389|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287390|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287391|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287392|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287393|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287394|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287395|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287396|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287397|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287398|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287399|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287400|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287401|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287402|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287403|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287404|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287405|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287406|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287407|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287408|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287409|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287410|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
287527|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287411|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
287412|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287413|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287414|NCT00116805|O2|Outcome|ADV-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287415|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287416|NCT00116805|O2|Outcome|ADV-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287417|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287418|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287419|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287420|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287421|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287422|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287423|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287424|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287425|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287426|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287427|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287428|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287429|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287430|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287431|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287432|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287433|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287434|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287435|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287436|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287528|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287437|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287438|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287439|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287440|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287441|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287442|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287443|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287444|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287445|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287446|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287447|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287448|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287449|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287450|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287451|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period..
287452|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287453|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287454|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287455|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287456|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287457|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287458|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287459|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287460|NCT00116805|O2|Outcome|ADV 10 mg|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287461|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
287529|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287530|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287531|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287462|NCT00116805|E3|Reported Event|Open-Label TDF|"Adverse events for this reporting group include those occurring during the open-label TDF 300 mg period (Week 49 up to Week 480), regardless of which group they were randomized to in the double-blind period.
TDF 300 mg + ADV placebo or ADV 10 mg + TDF placebo (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period."
287463|NCT00116805|E2|Reported Event|Double-Blind ADV|"Adverse events this reporting group include those occurring in the ADV-TDF group during the double-blind period only (baseline to Week 48).
ADV 10 mg plus placebo to match TDF (double-blind period)."
287464|NCT00116805|E1|Reported Event|Double-Blind TDF|"Adverse events this reporting group include those occurring in the TDF-TDF group during the double-blind period only (baseline to Week 48).
TDF 300 mg plus placebo to match ADV (double-blind period)."
287465|NCT00116831|B3|Baseline|Total|Total of all reporting groups
287466|NCT00116831|B2|Baseline|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287467|NCT00116831|B1|Baseline|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287468|NCT00116831|P2|Participant Flow|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287469|NCT00116831|P1|Participant Flow|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287470|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287471|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287472|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287473|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287474|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287475|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287476|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287477|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287478|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287479|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287480|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287481|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287482|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287483|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287484|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287485|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287486|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287487|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287488|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287489|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287490|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287491|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287492|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287493|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287494|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287495|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287496|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287497|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287498|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287499|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287500|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287501|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287502|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287503|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287504|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287505|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287506|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287507|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287508|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287509|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287510|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287511|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287512|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287513|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287514|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287515|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287516|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287517|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287518|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287519|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287532|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287533|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287534|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287535|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287536|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287537|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287538|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287539|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287540|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287541|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287542|NCT00116831|E2|Reported Event|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
287543|NCT00116831|E1|Reported Event|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
287544|NCT00116857|B3|Baseline|Total|Total of all reporting groups
287545|NCT00116857|B2|Baseline|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
287546|NCT00116857|B1|Baseline|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
287547|NCT00116857|P2|Participant Flow|Sertraline/Corn Oil|Sertraline 50mg 1 tablet by mouth everyday. Plus corn oil placebo capsules 2 g by mouth everyday.
287548|NCT00116857|P1|Participant Flow|Sertraline Plus Omega-3 Supplement|Sertraline 50mg 1 tablet by mouth everyday. Plus Omega-3 supplement capsules 2g by mouth everyday.
287549|NCT00116857|O2|Outcome|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
287550|NCT00116857|O1|Outcome|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
287551|NCT00116857|E2|Reported Event|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
287552|NCT00116857|E1|Reported Event|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
287553|NCT00118092|B1|Baseline|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
287554|NCT00118092|P1|Participant Flow|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
287555|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|"Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15.
> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
287556|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
287557|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
287558|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|"Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15.
> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
287559|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
287560|NCT00118092|E1|Reported Event|Treatment (Tanespimycin)|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
287561|NCT00118131|B1|Baseline|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.
Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).
Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).
Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
287562|NCT00118131|P1|Participant Flow|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.
Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).
Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).
Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
287563|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.
Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).
Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).
Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
287564|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.
Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).
Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).
Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
287565|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.
Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).
Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).
Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
287566|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.
Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).
Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).
Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
287567|NCT00118131|E1|Reported Event|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.
Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).
Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).
Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
287568|NCT00118144|B1|Baseline|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
287569|NCT00118144|P1|Participant Flow|Arm I|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
287570|NCT00118144|O1|Outcome|Arm I|"Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
bortezomib: Given IV"
287571|NCT00118144|O1|Outcome|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
287572|NCT00118144|O1|Outcome|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
287573|NCT00118144|E1|Reported Event|Arm I|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
287574|NCT00118157|B1|Baseline|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.
lapatinib ditosylate: Given orally
tamoxifen citrate: Given orally"
287575|NCT00118157|P1|Participant Flow|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.
lapatinib ditosylate: Given orally
tamoxifen citrate: Given orally"
287576|NCT00118157|O1|Outcome|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.
lapatinib ditosylate: Given orally
tamoxifen citrate: Given orally"
287577|NCT00118157|E1|Reported Event|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.
lapatinib ditosylate: Given orally
tamoxifen citrate: Given orally"
287578|NCT00118248|B3|Baseline|Total|Total of all reporting groups
287579|NCT00118248|B2|Baseline|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287580|NCT00118248|B1|Baseline|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287581|NCT00118248|P2|Participant Flow|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287582|NCT00118248|P1|Participant Flow|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287583|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287584|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287585|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287586|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287587|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287588|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287589|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287590|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287591|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287592|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287593|NCT00118248|E1|Reported Event|All Patients|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
287594|NCT00118287|B1|Baseline|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
etanercept: Given SC"
287595|NCT00118287|P1|Participant Flow|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
etanercept: Given SC"
287596|NCT00118287|O1|Outcome|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
etanercept: Given SC"
287597|NCT00118287|E1|Reported Event|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
etanercept: Given SC"
287598|NCT00118352|B4|Baseline|Total|Total of all reporting groups
287810|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287811|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287599|NCT00118352|B3|Baseline|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287600|NCT00118352|B2|Baseline|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287601|NCT00118352|B1|Baseline|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287602|NCT00118352|P3|Participant Flow|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
NOTE: No subjects were enrolled at this dose level as the escalation rule was not met."
287603|NCT00118352|P2|Participant Flow|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
NOTE: No subjects were enrolled at this dose level as the escalation rule was not met."
287604|NCT00118352|P1|Participant Flow|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287605|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287606|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287607|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287608|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287609|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287610|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287611|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287647|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287812|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287612|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287613|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287614|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287615|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287616|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287617|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287618|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287619|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287620|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287621|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287622|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287623|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287624|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287625|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
288615|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
287626|NCT00118352|E3|Reported Event|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287627|NCT00118352|E2|Reported Event|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Alemtuzumab: Given IV
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287628|NCT00118352|E1|Reported Event|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.
Total-body irradiation: Undergo low-dose total-body irradiation
Fludarabine phosphate: Given IV
Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
287629|NCT00118365|B3|Baseline|Total|Total of all reporting groups
287630|NCT00118365|B2|Baseline|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287631|NCT00118365|B1|Baseline|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287632|NCT00118365|P2|Participant Flow|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287633|NCT00118365|P1|Participant Flow|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287634|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287635|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287636|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287637|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287638|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287639|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287640|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287641|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287642|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287643|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287644|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287645|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287646|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287648|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287649|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287650|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287651|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287652|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287653|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287654|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287655|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287656|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287657|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287658|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287659|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287660|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287661|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287662|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
287663|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
287664|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
287665|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
287666|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
287667|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
287668|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287669|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287670|NCT00118365|O4|Outcome|Placebo + Spd:Spm Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline"
287671|NCT00118365|O3|Outcome|Placebo + Spd:Spm Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
SpSpd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline"
287672|NCT00118365|O2|Outcome|Eflornithine and Sulindac + Spd:Spm Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline"
287673|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Spd:Spm Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
Spd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline"
287674|NCT00118365|O4|Outcome|Placebo + Putrescine Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline"
287675|NCT00118365|O3|Outcome|Placebo + Putrescine Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline"
287676|NCT00118365|O2|Outcome|Eflornithine and Sulindac + Putrescine Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline"
287677|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Putrescine Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline"
287678|NCT00118365|O4|Outcome|Placebo + PGE2 Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline"
287679|NCT00118365|O3|Outcome|Placebo + PGE2 Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline"
287680|NCT00118365|O2|Outcome|Eflornithine and Sulindac + PGE2 Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline"
287681|NCT00118365|O1|Outcome|Eflornithine and Sulindac + PGE2 Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline"
287682|NCT00118365|O4|Outcome|Placebo + High Spd:Spm at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
baseline spermidine-to-spermine ratio is above median"
287683|NCT00118365|O3|Outcome|Placebo + Low Spd:Spm at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
baseline spermidine-to-spermine ratio is below median"
287684|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High Spd:Spm at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
baseline spermidine-to-spermine ratio is above the median"
287685|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low Spd:Spm at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
baseline spermidine-to-spermine ratio is below the median"
287686|NCT00118365|O4|Outcome|Placebo + High Putrescine at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
baseline Putrescine value is above median"
287687|NCT00118365|O3|Outcome|Placebo + Low Putrescine at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
baseline Putrescine value is below median"
287688|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High Putrescine at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
baseline Putrescine values is above the median"
287689|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low Putrescine at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
baseline Putrescine values is below the median"
287761|NCT00118430|E2|Reported Event|Usual Care|"Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
328460|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
287690|NCT00118365|O4|Outcome|Placebo + High PGE2 at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
baseline PGE2 value is above median"
287691|NCT00118365|O3|Outcome|Placebo + Low PGE2 at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies
baseline PGE2 value is below median"
287692|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High PGE2 at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
baseline PGE2 values is above the median"
287693|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low PGE2 at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies
baseline PGE2 values is below the median"
287694|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287695|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287696|NCT00118365|E2|Reported Event|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
287697|NCT00118365|E1|Reported Event|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
eflornithine: Given orally
sulindac: Given orally
laboratory biomarker analysis: Correlative studies"
287698|NCT00118378|B3|Baseline|Total|Total of all reporting groups
287699|NCT00118378|B2|Baseline|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
287700|NCT00118378|B1|Baseline|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
287701|NCT00118378|P2|Participant Flow|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
287702|NCT00118378|P1|Participant Flow|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
287703|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks.
287704|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks.
287705|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks.
287706|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks.
287707|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
287708|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
287709|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
287710|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
287711|NCT00118378|E2|Reported Event|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
287712|NCT00118378|E1|Reported Event|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
287713|NCT00118404|B4|Baseline|Total|Total of all reporting groups
287714|NCT00118404|B3|Baseline|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
287715|NCT00118404|B2|Baseline|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
287716|NCT00118404|B1|Baseline|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
287717|NCT00118404|P3|Participant Flow|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
287718|NCT00118404|P2|Participant Flow|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
287806|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287807|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287719|NCT00118404|P1|Participant Flow|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
287720|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
287721|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
287722|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
287723|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
287724|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
287725|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
287726|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
287727|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
287728|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
287729|NCT00118404|E3|Reported Event|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
287730|NCT00118404|E2|Reported Event|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
287731|NCT00118404|E1|Reported Event|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
287732|NCT00118417|B1|Baseline|All Participants|
287733|NCT00118417|P2|Participant Flow|Sertraline / + Placebo / Cognitive Behavior Therapy Augment.|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive their SSRI plus a placebo; In Phase 3, this group will receive their SSRI plus cognitive behavioral therapy (CBT)
287734|NCT00118417|P1|Participant Flow|Sertraline / Increased Dose / Medication Optimization|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive an increased dosage of their SSRI; In Phase 3, this group will receive medication optimization, which includes an SSRI and clonazepam
287735|NCT00118417|O2|Outcome|Augmented Cognitive Behavior Therapy|This group will receive sertraline or escitalopram with cognitive behavioral therapy (CBT)
287736|NCT00118417|O1|Outcome|Medication Optimization|This group will receive medication optimization, which includes sertraline or escitalopram with clonazepam
287737|NCT00118417|O2|Outcome|Sertraline Plus Placebo|This group will receive sertraline or escitalopram with a placebo
287738|NCT00118417|O1|Outcome|Increased Sertraline|This group will receive an increased dosage of sertraline or escitalopram
287739|NCT00118417|O1|Outcome|Moderate Sertraline Treatment|This group will receive moderate sertraline or escitalopram treatment
287740|NCT00118417|E3|Reported Event|Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam|
287741|NCT00118417|E2|Reported Event|Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone|
287742|NCT00118417|E1|Reported Event|Phase I: Sertraline|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI).
287743|NCT00118430|B4|Baseline|Total|Total of all reporting groups
287744|NCT00118430|B3|Baseline|No Treatment|Participants without depression group
287745|NCT00118430|B2|Baseline|Usual Care|"Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
287808|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287746|NCT00118430|B1|Baseline|Stepped Care|"Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
287747|NCT00118430|P3|Participant Flow|No Treatment|Participants without depression group
287748|NCT00118430|P2|Participant Flow|Usual Care|"Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
287749|NCT00118430|P1|Participant Flow|Stepped Care|"Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly with a physician-investigator to review cases, the physician-investigator will be available at all times to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response
Antidepressants: Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg"
287750|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
287751|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
287752|NCT00118430|O3|Outcome|No Treatment|Participants without depression group
287753|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
287754|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
287755|NCT00118430|O3|Outcome|No Treatment|Participants without depression group
287756|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
287757|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
287758|NCT00118430|O3|Outcome|No Treatment|Participants without depression group
287759|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group
Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
287760|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
287809|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287762|NCT00118430|E1|Reported Event|Stepped Care|"Stepped care group
Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
287763|NCT00118482|B3|Baseline|Total|Total of all reporting groups
287764|NCT00118482|B2|Baseline|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
287765|NCT00118482|B1|Baseline|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
287766|NCT00118482|P2|Participant Flow|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
287767|NCT00118482|P1|Participant Flow|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
287768|NCT00118482|O2|Outcome|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
287769|NCT00118482|O1|Outcome|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
287770|NCT00118482|O2|Outcome|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
287771|NCT00118482|O1|Outcome|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
287772|NCT00118482|E2|Reported Event|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
287773|NCT00118482|E1|Reported Event|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
287774|NCT00118534|B3|Baseline|Total|Total of all reporting groups
287775|NCT00118534|B2|Baseline|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287776|NCT00118534|B1|Baseline|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287777|NCT00118534|P2|Participant Flow|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287778|NCT00118534|P1|Participant Flow|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287779|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287780|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287781|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287782|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287783|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287784|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287785|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287786|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287787|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287788|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287789|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287790|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287791|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287792|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287793|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287794|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287795|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287796|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287797|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287798|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287799|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287800|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287801|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287802|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287803|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287804|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287805|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287813|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287814|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287815|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287816|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287817|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287818|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287819|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287820|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287821|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287822|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287823|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287824|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287825|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287826|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287827|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287828|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287829|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287830|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287831|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287832|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287833|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287834|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287835|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287836|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287837|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287838|NCT00118534|O1|Outcome|Integrated Care|Integration of Smoking Cessation therapy with PTSD therapy.
287839|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287840|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287841|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287842|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287843|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287844|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287845|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287846|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287847|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287848|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287849|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287850|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287851|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287852|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287853|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287854|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287855|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287856|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287857|NCT00118534|E2|Reported Event|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
287858|NCT00118534|E1|Reported Event|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
287859|NCT00118703|B3|Baseline|Total|Total of all reporting groups
287860|NCT00118703|B2|Baseline|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287921|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
328461|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
287861|NCT00118703|B1|Baseline|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287862|NCT00118703|P2|Participant Flow|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287863|NCT00118703|P1|Participant Flow|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril once daily (QD) in the morning (ante meridian [AM]), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287864|NCT00118703|O2|Outcome|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287865|NCT00118703|O1|Outcome|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287866|NCT00118703|O2|Outcome|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287867|NCT00118703|O1|Outcome|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287868|NCT00118703|O2|Outcome|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287869|NCT00118703|O1|Outcome|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287870|NCT00118703|E2|Reported Event|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287871|NCT00118703|E1|Reported Event|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
287872|NCT00118742|B3|Baseline|Total|Total of all reporting groups
287873|NCT00118742|B2|Baseline|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
287874|NCT00118742|B1|Baseline|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
287875|NCT00118742|P2|Participant Flow|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
287876|NCT00118742|P1|Participant Flow|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
287877|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
287878|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
287879|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
287880|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
287881|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
287882|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
287883|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
287884|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
287885|NCT00118742|E2|Reported Event|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
287886|NCT00118742|E1|Reported Event|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
287887|NCT00118755|B3|Baseline|Total|Total of all reporting groups
287888|NCT00118755|B2|Baseline|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.
Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
287889|NCT00118755|B1|Baseline|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.
Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
287890|NCT00118755|P2|Participant Flow|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.
Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
287891|NCT00118755|P1|Participant Flow|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.
Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
287892|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.
Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
287893|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.
Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
287894|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.
Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
287895|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.
Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
287896|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.
Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
287897|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.
Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
287898|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.
Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
287899|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.
Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
287900|NCT00118755|E2|Reported Event|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.
Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
287901|NCT00118755|E1|Reported Event|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.
Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
287902|NCT00118898|B5|Baseline|Total|Total of all reporting groups
287903|NCT00118898|B4|Baseline|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287904|NCT00118898|B3|Baseline|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287905|NCT00118898|B2|Baseline|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287906|NCT00118898|B1|Baseline|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287907|NCT00118898|P4|Participant Flow|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287908|NCT00118898|P3|Participant Flow|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287909|NCT00118898|P2|Participant Flow|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287910|NCT00118898|P1|Participant Flow|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287911|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287912|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287913|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287914|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287915|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287916|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287917|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287918|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287919|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287920|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287922|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287923|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287924|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287925|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287926|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287927|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287928|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287929|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287930|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287931|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287932|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287933|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287934|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287935|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287936|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287937|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287938|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287939|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287940|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287941|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287942|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287943|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287944|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287945|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287946|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287947|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287948|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287949|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287950|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287951|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287952|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287953|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287954|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287955|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287956|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287957|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287958|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287959|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287960|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287961|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287962|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287963|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
328462|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
287964|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287965|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287966|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287967|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287968|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287969|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287970|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287971|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287972|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287973|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287974|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287975|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287976|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287977|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287978|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287979|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287980|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287981|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287982|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287983|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287984|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287985|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287986|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287987|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287988|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287989|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287990|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287991|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287992|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287993|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287994|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287995|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287996|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287997|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
287998|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
287999|NCT00118898|E4|Reported Event|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
288000|NCT00118898|E3|Reported Event|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
288001|NCT00118898|E2|Reported Event|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
288002|NCT00118898|E1|Reported Event|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
288003|NCT00118911|B3|Baseline|Total|Total of all reporting groups
288004|NCT00118911|B2|Baseline|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
288005|NCT00118911|B1|Baseline|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
328463|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
288006|NCT00118911|P2|Participant Flow|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
288007|NCT00118911|P1|Participant Flow|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
288008|NCT00118911|O2|Outcome|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
288009|NCT00118911|O1|Outcome|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
288010|NCT00118911|O2|Outcome|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
288011|NCT00118911|O1|Outcome|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
288012|NCT00118911|E2|Reported Event|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
288013|NCT00118911|E1|Reported Event|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
288014|NCT00119015|B3|Baseline|Total|Total of all reporting groups
288015|NCT00119015|B2|Baseline|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Placebo - 10 mg po daily for 2 weeks"
288016|NCT00119015|B1|Baseline|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Montelukast - 10 mg po daily for 2 weeks"
288017|NCT00119015|P3|Participant Flow|Fluticasone Propionate+Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
Placebo - 10 mg po daily"
288018|NCT00119015|P2|Participant Flow|Fluticasone Propionate+Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
Montelukast - 10 mg po daily"
288019|NCT00119015|P1|Participant Flow|Fluticasone Propionate Only|Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
288020|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Placebo - 10 mg po daily for 2 weeks"
288021|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Montelukast - 10 mg po daily for 2 weeks"
288022|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Placebo - 10 mg po daily for 2 weeks"
288023|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Montelukast - 10 mg po daily for 2 weeks"
288024|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Placebo - 10 mg po daily for 2 weeks"
288025|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Montelukast - 10 mg po daily for 2 weeks"
288026|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Placebo - 10 mg po daily for 2 weeks"
288027|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Montelukast - 10 mg po daily for 2 weeks"
288028|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Placebo - 10 mg po daily for 2 weeks"
288029|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Montelukast - 10 mg po daily for 2 weeks"
288030|NCT00119015|E2|Reported Event|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Placebo - 10 mg po daily for 2 weeks"
288031|NCT00119015|E1|Reported Event|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
Montelukast - 10 mg po daily for 2 weeks"
288032|NCT00119041|B4|Baseline|Total|Total of all reporting groups
288033|NCT00119041|B3|Baseline|Provider Interview|Qualitative interviews with providers
288034|NCT00119041|B2|Baseline|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
288035|NCT00119041|B1|Baseline|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.
The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
We did not collect gender and age related data."
288036|NCT00119041|P3|Participant Flow|Provider Interview|Qualitative interviews with providers
288037|NCT00119041|P2|Participant Flow|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
288062|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
288063|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
288064|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
288038|NCT00119041|P1|Participant Flow|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.
The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
288039|NCT00119041|O2|Outcome|Control|non intervention group
288040|NCT00119041|O1|Outcome|Telemedicine|Intervention group
288041|NCT00119041|O2|Outcome|Control CBOC|Received the questionnaires by mail and had no intervention of diabetes teleconference
288042|NCT00119041|O1|Outcome|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.
The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.
The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
288043|NCT00119041|E3|Reported Event|Provider Interviews|Qualitative interviews with providers.
288044|NCT00119041|E2|Reported Event|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
288045|NCT00119041|E1|Reported Event|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.
The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.
The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
288046|NCT00119158|B3|Baseline|Total|Total of all reporting groups
288047|NCT00119158|B2|Baseline|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
288048|NCT00119158|B1|Baseline|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
288049|NCT00119158|P2|Participant Flow|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
288050|NCT00119158|P1|Participant Flow|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
288051|NCT00119158|O2|Outcome|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
288052|NCT00119158|O1|Outcome|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
288053|NCT00119158|O2|Outcome|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
288054|NCT00119158|O1|Outcome|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
288055|NCT00119158|E2|Reported Event|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
288056|NCT00119158|E1|Reported Event|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
288057|NCT00119262|B3|Baseline|Total|Total of all reporting groups
288058|NCT00119262|B2|Baseline|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
288059|NCT00119262|B1|Baseline|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
288060|NCT00119262|P2|Participant Flow|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
288061|NCT00119262|P1|Participant Flow|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
288616|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288065|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
288066|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
288067|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
288068|NCT00119262|E2|Reported Event|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
288069|NCT00119262|E1|Reported Event|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
288070|NCT00119379|B3|Baseline|Total|Total of all reporting groups
288071|NCT00119379|B2|Baseline|Switch to TDF|"Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
288072|NCT00119379|B1|Baseline|Uridine Supplementation|"NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day"
288073|NCT00119379|P2|Participant Flow|Switch to TDF|"Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
288074|NCT00119379|P1|Participant Flow|Uridine Supplementation|"NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day"
288075|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
288076|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day"
288077|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
288078|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day"
288079|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
288080|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day"
288081|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
288082|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day"
288083|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
288084|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day"
288085|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
288086|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day"
288087|NCT00119379|E2|Reported Event|Switch to TDF|"Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
288088|NCT00119379|E1|Reported Event|Uridine Supplementation|"NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day"
288089|NCT00119392|B1|Baseline|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI"
288090|NCT00119392|P1|Participant Flow|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI"
288091|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI"
288092|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI"
288093|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI"
288094|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI"
288095|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI"
288175|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
288617|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288096|NCT00119392|E1|Reported Event|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI"
288097|NCT00119405|B1|Baseline|ARV Naive|ARV naive
288098|NCT00119405|P1|Participant Flow|ARV Naive|ARV naive
288099|NCT00119405|O1|Outcome|ARV Naive|ARV naive (have never been on antiretrovirals before)
288100|NCT00119405|E1|Reported Event|ARV Naive|ARV naive (have never been on antiretrovirals before)
288101|NCT00119678|B3|Baseline|Total|Total of all reporting groups
288102|NCT00119678|B2|Baseline|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288103|NCT00119678|B1|Baseline|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288104|NCT00119678|P2|Participant Flow|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288105|NCT00119678|P1|Participant Flow|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288106|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288107|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288108|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg). Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. BILAG A: presence of one or more serious features of lupus; BILAG B: more moderate features of the disease; BILAG C: mild symptomatic features; BILAG D: prior activity with no current symptoms due to active lupus; BILAG E: an organ that has never been involved."
288109|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288110|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288618|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288111|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288112|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288113|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288114|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288115|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288116|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288117|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288118|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288119|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
288120|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288121|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288122|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288176|NCT00120250|E1|Reported Event|Drug vs Placebo|Eszopiclone : The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
288123|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288124|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288125|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288126|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288127|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288128|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288129|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288130|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288177|NCT00120289|B3|Baseline|Total|Total of all reporting groups
288619|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288131|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288132|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288133|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288134|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288135|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288136|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288137|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288138|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288365|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288139|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288140|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288141|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288142|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288143|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288144|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288145|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288146|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288366|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288147|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288148|NCT00119678|E2|Reported Event|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
288149|NCT00119678|E1|Reported Event|Abatacept|"Participants were administered abatacept (10 mg/kg) IV over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
288150|NCT00120042|B4|Baseline|Total|Total of all reporting groups
288151|NCT00120042|B3|Baseline|3|Oral misoprostol to assist in placental delivery
288152|NCT00120042|B2|Baseline|2|Intramuscular oxytocin injection
288153|NCT00120042|B1|Baseline|1|No specific oxytocic to assist in placental delivery
288154|NCT00120042|P3|Participant Flow|3|Oral misoprostol to assist in placental delivery
288155|NCT00120042|P2|Participant Flow|2|Intramuscular oxytocin injection
288156|NCT00120042|P1|Participant Flow|1|No specific oxytocic to assist in placental delivery
288157|NCT00120042|O3|Outcome|3|Oral misoprostol to assist in placental delivery
288158|NCT00120042|O2|Outcome|2|Intramuscular oxytocin injection
288159|NCT00120042|O1|Outcome|1|No specific oxytocic to assist in placental delivery
288160|NCT00120042|O3|Outcome|3|Oral misoprostol to assist in placental delivery
288161|NCT00120042|O2|Outcome|2|Intramuscular oxytocin injection
288162|NCT00120042|O1|Outcome|1|No specific oxytocic to assist in placental delivery
288163|NCT00120250|B1|Baseline|Drug vs Placebo|Eszopiclone : The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
288164|NCT00120250|P2|Participant Flow|Placebo, Then Eszopiclone|The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
288165|NCT00120250|P1|Participant Flow|Eszopiclone, Then Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
288166|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
288167|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
288168|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
288169|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
288170|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
288171|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
288172|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
288173|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
288174|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
288620|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288178|NCT00120289|B2|Baseline|Placebo + Simvastatin|"Simvastatin alone
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288179|NCT00120289|B1|Baseline|ERN + Simvastatin|"Extended release niacin plus simvastatin
Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288180|NCT00120289|P2|Participant Flow|Placebo + Simvastatin|"Simvastatin alone
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288181|NCT00120289|P1|Participant Flow|ERN + Simvastatin|"Extended release niacin plus simvastatin
Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288182|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288183|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin
Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288184|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288185|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin
Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288186|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288187|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin
Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288188|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288189|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin
Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288190|NCT00120289|E2|Reported Event|Placebo + Simvastatin|"Simvastatin alone
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288191|NCT00120289|E1|Reported Event|ERN + Simvastatin|"Extended release niacin plus simvastatin
Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated
Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
288192|NCT00120406|B3|Baseline|Total|Total of all reporting groups
288193|NCT00120406|B2|Baseline|PTA (Control)|Percutaneous balloon angioplasty
288194|NCT00120406|B1|Baseline|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
288195|NCT00120406|P2|Participant Flow|PTA (Control)|Percutaneous balloon angioplasty
288196|NCT00120406|P1|Participant Flow|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
288197|NCT00120406|O2|Outcome|PTA (Control)|Percutaneous balloon angioplasty
288198|NCT00120406|O1|Outcome|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
288199|NCT00120406|O2|Outcome|PTA (Control)|Percutaneous balloon angioplasty
288200|NCT00120406|O1|Outcome|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
288201|NCT00120406|E2|Reported Event|PTA (Control)|Percutaneous balloon angioplasty
288202|NCT00120406|E1|Reported Event|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
288203|NCT00120523|B3|Baseline|Total|Total of all reporting groups
288204|NCT00120523|B2|Baseline|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288205|NCT00120523|B1|Baseline|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288206|NCT00120523|P2|Participant Flow|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288207|NCT00120523|P1|Participant Flow|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288208|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288209|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288210|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288211|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288212|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288213|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288214|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288215|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288216|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288217|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288218|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288219|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288220|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288221|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288222|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288223|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288224|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288225|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288226|NCT00120523|E2|Reported Event|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.
Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
288227|NCT00120523|E1|Reported Event|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
288228|NCT00120627|B3|Baseline|Total|Total of all reporting groups
288229|NCT00120627|B2|Baseline|Control Arm: Medication & Case Management Alone|"Usual care consisting of medication and case-management.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288230|NCT00120627|B1|Baseline|Treatment Arm: Mantram + Medication & Case Management|"Mantram Repetition Program (MRP) for PTSD delivered in this study as 6-week, 90-minute per week that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management. The MRP includes three strategies for training attention and managing symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools were presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states."
288231|NCT00120627|P2|Participant Flow|Arm 2: Usual Care|"Usual care consisting of medication and case-management.
Usual care consisted of medication and case management: Case management consisted of provider meetings with Veterans at least once per month and monitoring medications, if prescribed."
288257|NCT00112294|B1|Baseline|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288367|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288232|NCT00120627|P1|Participant Flow|Arm 1: Mantram + Usual Care|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
288233|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288234|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.
The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal."
288235|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288236|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.
The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal."
288237|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288238|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program (MRP) for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.
The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources."
288239|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288240|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
288241|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288242|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
288243|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288368|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288621|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288244|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
288245|NCT00120627|O2|Outcome|Arm 2: Meds & Case Management (Usual Care Alone)|"Usual Care defined as receiving medication management and case management, as needed.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288246|NCT00120627|O1|Outcome|Arm 1: Mantram + Meds & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
288247|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288248|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting.."
288249|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288250|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
288251|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care Alone)|"Usual Care defined as receiving medication management and case management, as needed.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288252|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
288253|NCT00120627|E2|Reported Event|Arm 2|"Usual Care defined as receiving medication management and case management, as needed.
Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
288254|NCT00120627|E1|Reported Event|Arm 1|"he MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
288255|NCT00112294|B3|Baseline|Total|Total of all reporting groups
288256|NCT00112294|B2|Baseline|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288258|NCT00112294|P2|Participant Flow|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288259|NCT00112294|P1|Participant Flow|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288260|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288261|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288262|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288263|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288264|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288265|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288266|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288267|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288268|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288269|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288270|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288271|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288272|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288273|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288274|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288363|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288275|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288276|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288277|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288278|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288279|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288280|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288281|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288282|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288283|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288284|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288285|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288286|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288287|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288288|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288289|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288290|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288364|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
328464|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
288291|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288292|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288293|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
288294|NCT00112294|E2|Reported Event|Taxane+Carboplatin|
288295|NCT00112294|E1|Reported Event|Cetuximab+Taxane+Carboplatin|
288296|NCT00112359|B3|Baseline|Total|Total of all reporting groups
288297|NCT00112359|B2|Baseline|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288298|NCT00112359|B1|Baseline|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288299|NCT00112359|P2|Participant Flow|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288300|NCT00112359|P1|Participant Flow|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288301|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288302|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288303|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288304|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288305|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288306|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288307|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288308|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288309|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288310|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288311|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288312|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288313|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288314|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288315|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288316|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288317|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288318|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288319|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288320|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288321|NCT00112359|E2|Reported Event|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
288322|NCT00112359|E1|Reported Event|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
288323|NCT00112385|B3|Baseline|Total|Total of all reporting groups
288324|NCT00112385|B2|Baseline|Placebo|Subjects will be given syringes containing placebo
288325|NCT00112385|B1|Baseline|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288326|NCT00112385|P2|Participant Flow|Placebo|Subjects will be given syringes containing placebo
288327|NCT00112385|P1|Participant Flow|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288328|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288329|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288330|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288331|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288332|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288333|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288334|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288335|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288336|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288337|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288338|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288339|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288340|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288341|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288342|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288343|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288344|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288345|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288346|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288347|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288348|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288349|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288350|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288351|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288352|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288353|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288354|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288355|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288356|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288357|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288358|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288359|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288360|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288361|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288362|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
328465|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
288369|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288370|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288371|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288372|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288373|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288374|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288375|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288376|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288377|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288378|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288379|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288380|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288381|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288382|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288383|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288384|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288385|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288386|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288387|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288388|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288389|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288390|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288391|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288392|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288393|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288394|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288395|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288396|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288397|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288398|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288399|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288400|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288401|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288402|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288403|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288404|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288405|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288406|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288407|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288408|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288409|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288410|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
288411|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288412|NCT00112385|E2|Reported Event|Placebo|Subjects will be given syringes containing placebo
288413|NCT00112385|E1|Reported Event|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
288414|NCT00112437|B6|Baseline|Total|Total of all reporting groups
288415|NCT00112437|B5|Baseline|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288416|NCT00112437|B4|Baseline|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288417|NCT00112437|B3|Baseline|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288418|NCT00112437|B2|Baseline|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288419|NCT00112437|B1|Baseline|Placebo|Placebo 1 tablet once a week
288420|NCT00112437|P15|Participant Flow|MK0822 50 mg / MK0822 50 mg|"12 Month Extension (Year 3)
During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table
during 3 years."
288611|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288421|NCT00112437|P14|Participant Flow|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288422|NCT00112437|P13|Participant Flow|MK0822 25 mg / MK0822 50 mg|"12 Month Extension (Year 3)
During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year."
288423|NCT00112437|P12|Participant Flow|MK0822 25 mg / Placebo|"12 Month Extension (Year 3)
During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year."
288424|NCT00112437|P11|Participant Flow|MK0822 10 mg / MK0822 50 mg|"12 Month Extension (Year 3)
During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year."
288425|NCT00112437|P10|Participant Flow|MK0822 10 mg / Placebo|"12 Month Extension (Year 3)
During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg
tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year."
288426|NCT00112437|P9|Participant Flow|MK0822 3 mg / MK0822 50 mg|"12 Month Extension (Year 3)
During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year."
288427|NCT00112437|P8|Participant Flow|MK0822 3 mg / Placebo|"12 Month Extension (Year 3)
During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year."
288428|NCT00112437|P7|Participant Flow|Placebo / MK0822 50 mg|"12 Month Extension (Year 3)
During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year."
288429|NCT00112437|P6|Participant Flow|Placebo / Placebo|"12 Month Extension (Year 3)
During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years."
288430|NCT00112437|P5|Participant Flow|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288431|NCT00112437|P4|Participant Flow|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288432|NCT00112437|P3|Participant Flow|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288433|NCT00112437|P2|Participant Flow|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288434|NCT00112437|P1|Participant Flow|Placebo|Placebo 1 tablet once a week.
288435|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288436|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288437|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288438|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288439|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288440|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288441|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288442|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288443|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288444|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288445|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288612|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288446|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288447|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288448|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288449|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288450|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288451|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288452|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288453|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288454|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288455|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288456|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288457|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288458|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288459|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288460|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288461|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288462|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288463|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288464|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288465|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288466|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288467|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288613|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288468|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288469|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288470|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288471|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288472|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288473|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288474|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288475|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288476|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288477|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288478|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288479|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288480|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288481|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288482|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288483|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288484|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288485|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288486|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288487|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288488|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288489|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288490|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288491|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288492|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288493|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288494|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288495|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288496|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288497|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288498|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288499|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288500|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288501|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288502|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288503|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288504|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288505|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288506|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288507|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288508|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288509|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288510|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288511|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288512|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288513|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288514|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288515|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288516|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288517|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288518|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288519|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288520|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288521|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288522|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288523|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288524|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288525|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288526|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288527|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288528|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288529|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288530|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288531|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288532|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288533|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288534|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288535|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288536|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288537|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288538|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288539|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288540|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288541|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288542|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288543|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288544|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288545|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288546|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288547|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288548|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288549|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288550|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288551|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288552|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288553|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288554|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288555|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288614|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288556|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288557|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288558|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288559|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288560|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288561|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
288562|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288563|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288564|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288565|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288566|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288567|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288568|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288569|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288570|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288571|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288572|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288573|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288574|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288575|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288576|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288577|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288578|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288579|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288580|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288581|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288582|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288583|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288584|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288585|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288586|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288587|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288588|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288589|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288590|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288591|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288592|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288593|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288594|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288595|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288596|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288597|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288598|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288599|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288600|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288601|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288602|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288603|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288604|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288605|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288606|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288607|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288608|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288609|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288610|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288622|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288623|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288624|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288625|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288626|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288627|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288628|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288629|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288630|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288631|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288632|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288633|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288634|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288635|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288636|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288637|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288638|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288639|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288640|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288641|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288642|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288643|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288644|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288645|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288646|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288647|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288648|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288649|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288650|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288651|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288652|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288653|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288654|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288655|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288656|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288657|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288658|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288659|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288660|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288661|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288662|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288663|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288664|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288665|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288666|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288667|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288668|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288669|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288670|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288671|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288672|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288673|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288674|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
288675|NCT00112437|E15|Reported Event|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
288676|NCT00112437|E14|Reported Event|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288677|NCT00112437|E13|Reported Event|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288678|NCT00112437|E12|Reported Event|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
288679|NCT00112437|E11|Reported Event|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
288680|NCT00112437|E10|Reported Event|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
288681|NCT00112437|E9|Reported Event|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
289400|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
288682|NCT00112437|E8|Reported Event|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
288683|NCT00112437|E7|Reported Event|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
288684|NCT00112437|E6|Reported Event|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
288685|NCT00112437|E5|Reported Event|MK0822 50 mg|50 mg MK0822 1 tablet once a week
288686|NCT00112437|E4|Reported Event|MK0822 25 mg|25 mg MK0822 1 tablet once a week
288687|NCT00112437|E3|Reported Event|MK0822 10 mg|10 mg MK0822 1 tablet once a week
288688|NCT00112437|E2|Reported Event|MK0822 3 mg|3 mg MK0822 1 tablet once a week
288689|NCT00112437|E1|Reported Event|Placebo|Placebo 1 tablet once a week
288690|NCT00112463|B1|Baseline|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
288691|NCT00112463|P1|Participant Flow|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
288692|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
288693|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|"Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
romidepsin: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting."
288694|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
288695|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
288696|NCT00112463|E1|Reported Event|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
288697|NCT00112489|B1|Baseline|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
288698|NCT00112489|P1|Participant Flow|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
288699|NCT00112489|O1|Outcome|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
288700|NCT00112489|E1|Reported Event|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
288701|NCT00112593|B1|Baseline|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
cyclosporine: Given IV or PO
mycophenolate mofetil: Given IV or PO
laboratory biomarker analysis: Correlative studies"
288702|NCT00112593|P1|Participant Flow|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
cyclosporine: Given IV or PO
mycophenolate mofetil: Given IV or PO
laboratory biomarker analysis: Correlative studies"
288756|NCT00112736|O1|Outcome|Phase 1 - 50mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
288703|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
cyclosporine: Given IV or PO
mycophenolate mofetil: Given IV or PO
laboratory biomarker analysis: Correlative studies"
288704|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
cyclosporine: Given IV or PO
mycophenolate mofetil: Given IV or PO
laboratory biomarker analysis: Correlative studies"
288705|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
cyclosporine: Given IV or PO
mycophenolate mofetil: Given IV or PO
laboratory biomarker analysis: Correlative studies"
288706|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
cyclosporine: Given IV or PO
mycophenolate mofetil: Given IV or PO
laboratory biomarker analysis: Correlative studies"
288707|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
cyclosporine: Given IV or PO
mycophenolate mofetil: Given IV or PO
laboratory biomarker analysis: Correlative studies"
288708|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
cyclosporine: Given IV or PO
mycophenolate mofetil: Given IV or PO
laboratory biomarker analysis: Correlative studies"
288709|NCT00112593|E1|Reported Event|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
cyclosporine: Given IV or PO
mycophenolate mofetil: Given IV or PO
laboratory biomarker analysis: Correlative studies"
288710|NCT00112671|B1|Baseline|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given orally
laboratory biomarker analysis: Correlative studies"
288711|NCT00112671|P1|Participant Flow|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given orally
laboratory biomarker analysis: Correlative studies"
289200|NCT00113841|P1|Participant Flow|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
288712|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given orally
laboratory biomarker analysis: Correlative studies"
288713|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given orally
laboratory biomarker analysis: Correlative studies"
288714|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given orally
laboratory biomarker analysis: Correlative studies"
288715|NCT00112671|E1|Reported Event|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given orally
laboratory biomarker analysis: Correlative studies"
288716|NCT00112723|B1|Baseline|Treatment (Alvocidib)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.
alvocidib: Given IV"
288717|NCT00112723|P3|Participant Flow|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
288718|NCT00112723|P2|Participant Flow|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
288719|NCT00112723|P1|Participant Flow|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
288720|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.
alvocidib: Given IV"
288721|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
288722|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
288723|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
288724|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
288725|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
288726|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
288727|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.
alvocidib: Given IV"
288728|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.
alvocidib: Given IV"
288729|NCT00112723|O3|Outcome|Cohort 4|Patients diagnosed with T Cell NHL
288730|NCT00112723|O2|Outcome|Cohort 2|Patients diagnosed with Mantle Cell NHL
288731|NCT00112723|O1|Outcome|Cohort 1|Patients diagnosed with Indolent B-cell NHL
288732|NCT00112723|O1|Outcome|Dose Levels 1, 2, 3|"Dose Level 1 (30 mg/m2 + 30 mg/m2), Dose Level 2 (30 mg/m2 + 50 mg/m2), Dose Level 3 (50 mg/m2 + 50 mg/m2)
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.
alvocidib: Given IV"
288733|NCT00112723|O3|Outcome|Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
288757|NCT00112736|O1|Outcome|Phase I - Dose Escalation|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at (dose escalation or dose de-escalation). Every 28 days until disease progression or unacceptable toxicity.
Dose levels: cohort 1 - 50mg - 3pts cohort 2 - 25mg -6pt cohort 3 - 15mg - 12pts"
288734|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
288735|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
288736|NCT00112723|O3|Outcome|Level 3 (50+50)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
288737|NCT00112723|O2|Outcome|Level 2 (30+50)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
288738|NCT00112723|O1|Outcome|Dose Level 1 (30+30)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.
alvocidib: Given IV"
288739|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
288740|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
288741|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
288742|NCT00112723|E1|Reported Event|Treatment (Alvocidib)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.
alvocidib: Given IV"
288743|NCT00112736|B4|Baseline|Total|Total of all reporting groups
288744|NCT00112736|B3|Baseline|Phase II n=43|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.
Glioblastoma
erlotinib: Given orally
temsirolimus: Given IV"
288745|NCT00112736|B2|Baseline|Phase II n=16|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.
Anaplastic Glioma
erlotinib: Given orally
temsirolimus: Given IV"
288746|NCT00112736|B1|Baseline|Phase I n=9|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.
erlotinib: Given orally
temsirolimus: Given IV"
288747|NCT00112736|P2|Participant Flow|Phase II (Erlotinib & Temsirolimus)|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.
PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies"
288748|NCT00112736|P1|Participant Flow|Phase I (Erlotinib & Temsirolimus)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.
erlotinib: Given orally
temsirolimus: Given IV
pharmacological study: Correlative studies"
288749|NCT00112736|O1|Outcome|Phase II n=43|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.
Glioblastoma
erlotinib: Given orally
temsirolimus: Given IV"
288750|NCT00112736|O3|Outcome|Phase 1 - 50mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
288751|NCT00112736|O2|Outcome|Phase 1 - 25 mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
288752|NCT00112736|O1|Outcome|Phase 1 - 15mg|PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
288753|NCT00112736|O1|Outcome|Phase I 15mg Temsirolimus (MTD Dose)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
erlotinib: Given orally
temsirolimus: Given IV"
288754|NCT00112736|O3|Outcome|Phase 1 - 15mg|PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
288755|NCT00112736|O2|Outcome|Phase 1 - 25 mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
288758|NCT00112736|E2|Reported Event|Phase II (Erlotinib & Erlotinib)|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.
PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies"
288759|NCT00112736|E1|Reported Event|Phase I (Erlotinib & Temsirolimus)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.
erlotinib: Given orally
temsirolimus: Given IV
pharmacological study: Correlative studies"
288760|NCT00112840|B4|Baseline|Total|Total of all reporting groups
288761|NCT00112840|B3|Baseline|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
288762|NCT00112840|B2|Baseline|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
288763|NCT00112840|B1|Baseline|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
288764|NCT00112840|P3|Participant Flow|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
288765|NCT00112840|P2|Participant Flow|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1= 10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
288766|NCT00112840|P1|Participant Flow|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
288767|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
288768|NCT00112840|O2|Outcome|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
288769|NCT00112840|O1|Outcome|Phase 1, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
288770|NCT00112840|O1|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
288771|NCT00112840|O1|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
288772|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
288855|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288773|NCT00112840|O2|Outcome|Phase 1, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
288774|NCT00112840|O1|Outcome|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and escalating doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
288775|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
288776|NCT00112840|O2|Outcome|Phase 1 , Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
288777|NCT00112840|O1|Outcome|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
288778|NCT00112840|E3|Reported Event|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
288779|NCT00112840|E2|Reported Event|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
288780|NCT00112840|E1|Reported Event|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
288781|NCT00112866|B3|Baseline|Total|Total of all reporting groups
288782|NCT00112866|B2|Baseline|High Dose 2000mg Group 2|"Preoperative Treatment: Patients receive high-dose 2000mg cilengitide IV over 1 hour on days -8, -4, and -1.
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
therapeutic conventional surgery: Undergo tumor resection
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
288783|NCT00112866|B1|Baseline|Low Dose 500mg Group 1|"Preoperative Treatment: Patients receive low dose 500mg cilengitide IV over 1 hour on days -8, -4, and -1.
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
therapeutic conventional surgery: Undergo tumor resection
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
288784|NCT00112866|P2|Participant Flow|High Dose 2000mg Group 2|"Preoperative Treatment: Patients receive high-dose cilengitide 2000mg IV over 1 hour on days -8, -4, and -1.
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
therapeutic conventional surgery: Undergo tumor resection
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
288785|NCT00112866|P1|Participant Flow|Low Dose 500mg Group 1|"Preoperative Treatment: Patients receive low dose cilengitide 500mg IV over 1 hour on days -8, -4, and -1.
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide 2000mg IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
therapeutic conventional surgery: Undergo tumor resection
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
288856|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288857|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288858|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288786|NCT00112866|O1|Outcome|Post-Operative Treatment 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
therapeutic conventional surgery: Undergo tumor resection
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
288787|NCT00112866|O2|Outcome|Group II (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity
cilengitide: Given IV
therapeutic conventional surgery: Undergo tumor resection
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
288788|NCT00112866|O1|Outcome|Group I (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
therapeutic conventional surgery: Undergo tumor resection
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
288789|NCT00112866|O2|Outcome|Group II High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity
cilengitide: Given IV
therapeutic conventional surgery: Undergo tumor resection
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
288790|NCT00112866|O1|Outcome|Group I (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg)
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive 2000mg high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
therapeutic conventional surgery: Undergo tumor resection
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
288791|NCT00112866|O2|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)
Resection: All patients undergo tumor resection on day 0.
cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection
laboratory biomarker analysis: Correlative studies"
288792|NCT00112866|O1|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)
Resection: All patients undergo tumor resection on day 0.
cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
288793|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)
Resection: All patients undergo tumor resection on day 0.
cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
288794|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)
Resection: All patients undergo tumor resection on day 0.
cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection
laboratory biomarker analysis: Correlative studies"
288795|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)
Resection: All patients undergo tumor resection on day 0.
cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection
laboratory biomarker analysis: Correlative studies"
288796|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)
Resection: All patients undergo tumor resection on day 0.
cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection
laboratory biomarker analysis: Correlative studies"
288797|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)
Resection: All patients undergo tumor resection on day 0.
cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
288798|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)
Resection: All patients undergo tumor resection on day 0.
cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection
laboratory biomarker analysis: Correlative studies"
288799|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)
Resection: All patients undergo tumor resection on day 0.
cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
288800|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)
Resection: All patients undergo tumor resection on day 0.
cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection
laboratory biomarker analysis: Correlative studies"
288801|NCT00112866|O1|Outcome|Post-Operative Treatment 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
pharmacological study: Correlative studies"
288908|NCT00113087|O2|Outcome|Placebo|Placebo suspension
328466|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
288802|NCT00112866|E1|Reported Event|Post-Operative 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
therapeutic conventional surgery: Undergo tumor resection
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
288803|NCT00112905|B1|Baseline|TCC Cohort|"Only eligible and treated patients are included in the analysis.
BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
288804|NCT00112905|P1|Participant Flow|TCC (Transitional Cell Carcinoma) Cohort|Sorafenib was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If sorafenib was taken with meals, patients were instructed to take sorafenib tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies. Patients were instructed to keep a pill diary and record the pills they took each day.
288805|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.
BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
288806|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.
BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
288807|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.
BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
288808|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.
BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
288809|NCT00112905|E1|Reported Event|TCC Cohort|"Only eligible and treated patients are included in the analysis.
BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
288810|NCT00112918|B4|Baseline|Total|Total of all reporting groups
288811|NCT00112918|B3|Baseline|XELOX+Bv|"Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).
Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288812|NCT00112918|B2|Baseline|FOLFOX4 + Bv|"Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288813|NCT00112918|B1|Baseline|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Observation only."
288834|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Observation only."
289010|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
288814|NCT00112918|P3|Participant Flow|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288815|NCT00112918|P2|Participant Flow|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288816|NCT00112918|P1|Participant Flow|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Observation only."
288817|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288818|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288819|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Observation only."
288820|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288821|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288822|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Observation only."
288823|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
289387|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
288824|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288825|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Observation only."
288826|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288827|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288828|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Observation only."
288829|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288830|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288831|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Observation only."
288832|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288833|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
289388|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
288835|NCT00112918|E3|Reported Event|XELOX+Bv|"Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).
Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288836|NCT00112918|E2|Reported Event|FOLFOX4 + Bv|"Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
288837|NCT00112918|E1|Reported Event|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).
Weeks 25-48: Observation only."
288838|NCT00113022|B3|Baseline|Total|Total of all reporting groups
288839|NCT00113022|B2|Baseline|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
288840|NCT00113022|B1|Baseline|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
288841|NCT00113022|P2|Participant Flow|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
288842|NCT00113022|P1|Participant Flow|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
288843|NCT00113022|O2|Outcome|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
288844|NCT00113022|O1|Outcome|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
288845|NCT00113022|E2|Reported Event|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
288846|NCT00113022|E1|Reported Event|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
288847|NCT00113087|B3|Baseline|Total|Total of all reporting groups
288848|NCT00113087|B2|Baseline|Placebo|Placebo suspension
288849|NCT00113087|B1|Baseline|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288850|NCT00113087|P2|Participant Flow|Placebo|Placebo suspension
288851|NCT00113087|P1|Participant Flow|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288852|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288853|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288854|NCT00113087|O2|Outcome|Placebo|Placebo suspension
328467|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
288859|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288860|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288861|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288862|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288863|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288864|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288865|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288866|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288867|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288868|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288869|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288870|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288871|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288872|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288873|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288874|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288875|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288876|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288877|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288878|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288879|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288880|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288881|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288882|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288883|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288884|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288885|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288886|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288887|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288888|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288889|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288890|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288891|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288892|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288893|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288894|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288895|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288896|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288897|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288898|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288899|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288900|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288901|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288902|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288903|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288904|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288905|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288906|NCT00113087|O2|Outcome|Placebo|Placebo suspension
288907|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288909|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288910|NCT00113087|E2|Reported Event|Placebo|Placebo suspension
288911|NCT00113087|E1|Reported Event|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
288912|NCT00113217|B1|Baseline|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
288913|NCT00113217|P1|Participant Flow|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
288914|NCT00113217|O1|Outcome|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
288915|NCT00113217|E1|Reported Event|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
288916|NCT00113230|B1|Baseline|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
288917|NCT00113230|P1|Participant Flow|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
288918|NCT00113230|O1|Outcome|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
288919|NCT00113230|E1|Reported Event|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
288920|NCT00113269|B5|Baseline|Total|Total of all reporting groups
288921|NCT00113269|B4|Baseline|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288922|NCT00113269|B3|Baseline|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288923|NCT00113269|B2|Baseline|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288924|NCT00113269|B1|Baseline|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288925|NCT00113269|P4|Participant Flow|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288926|NCT00113269|P3|Participant Flow|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288927|NCT00113269|P2|Participant Flow|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288928|NCT00113269|P1|Participant Flow|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288929|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288930|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288931|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288932|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288933|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288934|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288935|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288936|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288937|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288938|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288939|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288940|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288941|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288942|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
289011|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
288943|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288944|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288945|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288946|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288947|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288948|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288949|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288950|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288951|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288952|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288953|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288954|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288955|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288956|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288957|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288958|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288959|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288960|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288961|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288962|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288963|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288964|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288965|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288966|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288967|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288968|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288969|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288970|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288971|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288972|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288973|NCT00113269|E4|Reported Event|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288974|NCT00113269|E3|Reported Event|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
288975|NCT00113269|E2|Reported Event|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288976|NCT00113269|E1|Reported Event|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
288977|NCT00113295|B3|Baseline|Total|Total of all reporting groups
288978|NCT00113295|B2|Baseline|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
288979|NCT00113295|B1|Baseline|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
288980|NCT00113295|P2|Participant Flow|Placebo Augmentation of Continued Paroxetine|In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly titrated up to a maximum of 62.5 mg/day by week 10. Individuals who did not achieve remission and were randomized into the placebo group received placebo augmentation of continued paroxetine CR at the week 10 dose level.
288981|NCT00113295|P1|Participant Flow|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly tirated up to a maximum of 62.5 mg/day by week 10. Individuals who did not receive remission and were randomized to receive quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
288982|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
288983|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16(mean±SD endpoint dose=120.5±100.5 mg/day).
288984|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
288985|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
288986|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
288987|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
288988|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
288989|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16(mean±SD endpoint dose=120.5±100.5 mg/day).
288990|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
288991|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
288992|NCT00113295|E3|Reported Event|Paroxetine|Individuals received paroxetine CR for 10 weeks in Phase 1 of the study, initiated at 12.5 mg and flexibly titrated up to a maximum of 62.5 mg/day by week 8.
288993|NCT00113295|E2|Reported Event|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
288994|NCT00113295|E1|Reported Event|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
288995|NCT00113321|B1|Baseline|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
288996|NCT00113321|P1|Participant Flow|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
288997|NCT00113321|O1|Outcome|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
288998|NCT00113321|E1|Reported Event|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
288999|NCT00113334|B1|Baseline|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
289000|NCT00113334|P1|Participant Flow|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
289001|NCT00113334|O1|Outcome|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
289002|NCT00113334|E1|Reported Event|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
289003|NCT00113360|B1|Baseline|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
289004|NCT00113360|P1|Participant Flow|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
289005|NCT00113360|O1|Outcome|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
289006|NCT00113360|E1|Reported Event|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
289007|NCT00113373|B1|Baseline|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
289008|NCT00113373|P1|Participant Flow|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
289009|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
289078|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
289012|NCT00113373|E1|Reported Event|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
289013|NCT00113386|B3|Baseline|Total|Total of all reporting groups
289014|NCT00113386|B2|Baseline|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with on-study information, which is 7 patients.]
289015|NCT00113386|B1|Baseline|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery [Data is reported for eligible patients with on-study information, which is 8 patients.]
289016|NCT00113386|P2|Participant Flow|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative (induction) throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
289017|NCT00113386|P1|Participant Flow|Preoperative Cisplatin/Docetaxel|Preoperative (induction) cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery
289018|NCT00113386|O2|Outcome|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
289019|NCT00113386|O1|Outcome|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery
289020|NCT00113386|E2|Reported Event|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with adverse event information, which is 7 patients.]
289021|NCT00113386|E1|Reported Event|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with adverse event information, which is 9 patients.]
289022|NCT00113399|B3|Baseline|Total|Total of all reporting groups
289023|NCT00113399|B2|Baseline|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:
cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with on-study information, which is 7 patients.]"
289024|NCT00113399|B1|Baseline|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with on-study information, which is 6 patients.]
289025|NCT00113399|P2|Participant Flow|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:
cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with adverse event information, which is 7 patients.]"
289026|NCT00113399|P1|Participant Flow|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with adverse event information, which is 6 patients.]
289027|NCT00113399|O2|Outcome|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:
cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel"
289028|NCT00113399|O1|Outcome|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8
289029|NCT00113399|E2|Reported Event|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:
cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with adverse event information, which is 7 patients.]"
289030|NCT00113399|E1|Reported Event|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with adverse event information, which is 6 patients.]
289031|NCT00113425|B1|Baseline|Treated Group Pulsed Dye Laser Therapy and Untreated Group|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face and the contralateral side of the face remained untreated, thus serving as an internal control.
289032|NCT00113425|P1|Participant Flow|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289033|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289034|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289035|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289036|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289037|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289038|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289039|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289040|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289041|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289042|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289043|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289044|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289045|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289046|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
289047|NCT00113425|E2|Reported Event|Untreated Group Control|The contralateral side of the face remained untreated, thus serving as an internal control.
289048|NCT00113425|E1|Reported Event|Treated Group Pulsed Dye Laser Therapy|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face.
289049|NCT00113490|B3|Baseline|Total|Total of all reporting groups
289050|NCT00113490|B2|Baseline|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289051|NCT00113490|B1|Baseline|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289052|NCT00113490|P2|Participant Flow|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289053|NCT00113490|P1|Participant Flow|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289054|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289055|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289056|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289057|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289058|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289059|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289060|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289061|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289062|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289063|NCT00113490|E2|Reported Event|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289064|NCT00113490|E1|Reported Event|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
289065|NCT00113516|B1|Baseline|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
289066|NCT00113516|P2|Participant Flow|Sunitinib|Sunitinib 50 mg
289067|NCT00113516|P1|Participant Flow|Carboplatin Plus Paclitaxel|Carboplatin Plus Paclitaxel 172-225 mg/m2
289068|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
289069|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
289070|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
289071|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
289072|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
289073|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
289074|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
289075|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
289076|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
289077|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
289099|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
289100|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
289101|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
289102|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
289103|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
289104|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
289105|NCT00113516|E2|Reported Event|Sunitinib 50 mg (Part 2)|
289106|NCT00113516|E1|Reported Event|Carboplatin Plus Paclitaxel 172-225 mg/m2 (Part 1)|
289107|NCT00113529|B1|Baseline|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289108|NCT00113529|P1|Participant Flow|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 milligrams (mg) or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289109|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289110|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289111|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289112|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289113|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289114|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289115|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289116|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289199|NCT00113841|P2|Participant Flow|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
289117|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289118|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289119|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289120|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289121|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289122|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289123|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289124|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289125|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289126|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289127|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289128|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289144|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289129|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289130|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289131|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289132|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289133|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289134|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289135|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289136|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289137|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289138|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289139|NCT00113529|E1|Reported Event|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
289140|NCT00113568|B1|Baseline|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289141|NCT00113568|P1|Participant Flow|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289142|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289143|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289145|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289146|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289147|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289148|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289149|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289150|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289151|NCT00113568|E1|Reported Event|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
289152|NCT00113607|B3|Baseline|Total|Total of all reporting groups
289153|NCT00113607|B2|Baseline|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
289154|NCT00113607|B1|Baseline|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
289155|NCT00113607|P2|Participant Flow|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
289156|NCT00113607|P1|Participant Flow|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
289157|NCT00113607|O1|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
289158|NCT00113607|O1|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
289159|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
289160|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
289161|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
289162|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
289163|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
289164|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
289165|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
289166|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
289167|NCT00113607|E2|Reported Event|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
289168|NCT00113607|E1|Reported Event|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
289169|NCT00113763|B3|Baseline|Total|Total of all reporting groups
289170|NCT00113763|B2|Baseline|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289171|NCT00113763|B1|Baseline|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289172|NCT00113763|P2|Participant Flow|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289173|NCT00113763|P1|Participant Flow|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289174|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289175|NCT00113763|O1|Outcome|Panitumumab Plus Best Supportive Care|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289176|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289177|NCT00113763|O1|Outcome|Panitumumab Plus Best Supportive Care|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289178|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289179|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289180|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289181|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289182|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289183|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289184|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289185|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289186|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289187|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289188|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289189|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289190|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289191|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289192|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289193|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289194|NCT00113763|E2|Reported Event|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
289195|NCT00113763|E1|Reported Event|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
289196|NCT00113841|B3|Baseline|Total|Total of all reporting groups
289197|NCT00113841|B2|Baseline|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
289198|NCT00113841|B1|Baseline|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
289201|NCT00113841|O2|Outcome|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
289202|NCT00113841|O1|Outcome|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
289203|NCT00113841|E2|Reported Event|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
289204|NCT00113841|E1|Reported Event|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
289205|NCT00113880|B4|Baseline|Total|Total of all reporting groups
289206|NCT00113880|B3|Baseline|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289207|NCT00113880|B2|Baseline|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289208|NCT00113880|B1|Baseline|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the KP Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose. FluMist recipients served as their own controls based on the observation time after vaccination. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
289209|NCT00113880|P3|Participant Flow|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289210|NCT00113880|P2|Participant Flow|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289211|NCT00113880|P1|Participant Flow|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the KP Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose. FluMist recipients served as their own controls based on the observation time after vaccination. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
289212|NCT00113880|O3|Outcome|FluMist Recipients (18-49 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
289213|NCT00113880|O2|Outcome|FluMist Recipients (9-17 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
289214|NCT00113880|O1|Outcome|FluMist Recipients (5-8 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist.
289215|NCT00113880|O3|Outcome|FluMist Recipients (18-49 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
289216|NCT00113880|O2|Outcome|FluMist Recipients (9-17 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
289217|NCT00113880|O1|Outcome|FluMist Recipients (5-8 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist.
289218|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289219|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289389|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
289390|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289391|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
289220|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289221|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289222|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289223|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289224|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289225|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289226|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289227|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289228|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
289229|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289230|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289231|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289232|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289233|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289234|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289235|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289236|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289237|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289238|NCT00113880|O3|Outcome|Unvaccinated Controls|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289239|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289240|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289241|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289242|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289243|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289244|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289245|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289246|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289247|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289248|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
289249|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289250|NCT00113880|O4|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289392|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289251|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289252|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
289253|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289254|NCT00113880|O4|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289255|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289256|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
289257|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289258|NCT00113880|O4|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289259|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289260|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
289261|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289262|NCT00113880|O4|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
289263|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
289264|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
289393|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
289265|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
289266|NCT00113880|E1|Reported Event|FluMist Recipients|
289267|NCT00113919|B1|Baseline|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
289268|NCT00113919|P1|Participant Flow|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
289269|NCT00113919|O1|Outcome|Busulfex|
289270|NCT00113919|E1|Reported Event|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
289271|NCT00114101|B3|Baseline|Total|Total of all reporting groups
289272|NCT00114101|B2|Baseline|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
(closed as of 12/17/09)"
289273|NCT00114101|B1|Baseline|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
289274|NCT00114101|P2|Participant Flow|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
(closed as of 12/17/09)"
289275|NCT00114101|P1|Participant Flow|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
289276|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
(closed as of 12/17/09)"
289277|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
289278|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
(closed as of 12/17/09)"
289279|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
289280|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily.
(closed as of 12/17/09)"
289281|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily.
289282|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
(closed as of 12/17/09)"
289283|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
289284|NCT00114101|E2|Reported Event|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
(closed as of 12/17/09)"
289285|NCT00114101|E1|Reported Event|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
289286|NCT00114127|B3|Baseline|Total|Total of all reporting groups
289287|NCT00114127|B2|Baseline|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
289288|NCT00114127|B1|Baseline|Duloxetine 60mg/Day + Placebo for 18 Weeks(Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
289289|NCT00114127|P2|Participant Flow|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
289290|NCT00114127|P1|Participant Flow|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
289291|NCT00114127|O2|Outcome|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
289292|NCT00114127|O1|Outcome|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
289293|NCT00114127|O2|Outcome|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
289294|NCT00114127|O1|Outcome|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
289295|NCT00114127|E2|Reported Event|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
289296|NCT00114127|E1|Reported Event|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
289297|NCT00114166|B1|Baseline|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
289298|NCT00114166|P1|Participant Flow|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
289394|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289395|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
289299|NCT00114166|O1|Outcome|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
289300|NCT00114166|O1|Outcome|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
289301|NCT00114166|E2|Reported Event|Regimen II|Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
289302|NCT00114166|E1|Reported Event|Regimen I|Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
289303|NCT00114244|B3|Baseline|Total|Total of all reporting groups
289304|NCT00114244|B2|Baseline|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.
sorafenib tosylate: Given PO
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies"
289305|NCT00114244|B1|Baseline|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.
sorafenib tosylate: Given PO
laboratory biomarker analysis: Correlative studies"
289306|NCT00114244|P2|Participant Flow|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.
sorafenib tosylate: Given PO
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies"
289307|NCT00114244|P1|Participant Flow|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.
sorafenib tosylate: Given PO
laboratory biomarker analysis: Correlative studies"
289308|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.
sorafenib tosylate: Given PO
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies"
289309|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.
sorafenib tosylate: Given PO
laboratory biomarker analysis: Correlative studies"
289310|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.
sorafenib tosylate: Given PO
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies"
289311|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.
sorafenib tosylate: Given PO
laboratory biomarker analysis: Correlative studies"
289312|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.
sorafenib tosylate: Given PO
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies"
289313|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.
sorafenib tosylate: Given PO
laboratory biomarker analysis: Correlative studies"
289314|NCT00114244|E2|Reported Event|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and gemcitabine IV over 100 minutes on days 1, 8, and 15.
sorafenib tosylate: Given PO
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies"
289315|NCT00114244|E1|Reported Event|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.
sorafenib tosylate: Given PO
laboratory biomarker analysis: Correlative studies"
289316|NCT00120874|B3|Baseline|Total|Total of all reporting groups
289317|NCT00120874|B2|Baseline|Memantine|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289318|NCT00120874|B1|Baseline|Individualized Management and Memantine|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289319|NCT00120874|P2|Participant Flow|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289320|NCT00120874|P1|Participant Flow|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289321|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289322|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289323|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289396|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289397|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
289398|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289399|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
289324|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289325|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289326|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289327|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289328|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289329|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289330|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289331|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289332|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289333|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289334|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289335|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289336|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289337|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289338|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289339|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289340|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289341|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289342|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289343|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289344|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289345|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289346|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289347|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289348|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289349|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289350|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289351|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289352|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289353|NCT00120874|E2|Reported Event|Memantine|"Only Memantine
Memantine: Patients receive 10 milligrams of memantine twice daily."
289354|NCT00120874|E1|Reported Event|Individualized Management and Memantine|"Individualized Management including caregiver training and Memantine
Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
Memantine: Patients receive 10 milligrams of memantine twice daily."
289355|NCT00121472|B1|Baseline|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
289356|NCT00121472|P1|Participant Flow|HeartMate II (HMII)|HeartMate II Left Ventricular Assist System (HMII LVAS) used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP)).
289357|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
289358|NCT00121472|O1|Outcome|HMII Replacement|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
289359|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
289360|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
289361|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
289362|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
289363|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
289364|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
289365|NCT00121472|E1|Reported Event|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
289366|NCT00121485|B3|Baseline|Total|Total of all reporting groups
289367|NCT00121485|B2|Baseline|HeartMate XVE|Implantation of HeartMate XVE LVAS
289368|NCT00121485|B1|Baseline|HeartMate II|Implantation of HeartMate II LVAS
289369|NCT00121485|P2|Participant Flow|HeartMate XVE|Implantation of HeartMate XVE LVAS
289370|NCT00121485|P1|Participant Flow|HeartMate II|Implantation of HeartMate II LVAS
289371|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
289372|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289373|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
289374|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289375|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
289376|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289377|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
289378|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289379|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
289380|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289381|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
289382|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289383|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
289384|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289385|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
289386|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
289401|NCT00121485|E2|Reported Event|HeartMate XVE|Implantation of HeartMate XVE LVAS
289402|NCT00121485|E1|Reported Event|HeartMate II|Implantation of HeartMate II LVAS
289403|NCT00121641|B5|Baseline|Total|Total of all reporting groups
289404|NCT00121641|B4|Baseline|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289405|NCT00121641|B3|Baseline|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289406|NCT00121641|B2|Baseline|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289407|NCT00121641|B1|Baseline|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289408|NCT00121641|P5|Participant Flow|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289409|NCT00121641|P4|Participant Flow|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289410|NCT00121641|P3|Participant Flow|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289411|NCT00121641|P2|Participant Flow|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289412|NCT00121641|P1|Participant Flow|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT]); Metformin 500-2000 mg (as needed for rescue).
289413|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289414|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289415|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289416|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289417|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289418|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289419|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289420|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289421|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289422|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289423|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289424|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289425|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289426|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289427|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289428|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289429|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289430|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289431|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289432|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289433|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289434|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289435|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289436|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289437|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289438|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289439|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289440|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289441|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289442|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289443|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289444|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289445|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289446|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289447|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289448|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289449|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289450|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289451|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289452|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289453|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289454|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289455|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289456|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289457|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289458|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289459|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289460|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289461|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289462|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289463|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289464|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289465|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289466|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289467|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289468|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289469|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289470|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289471|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289472|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289473|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289474|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289475|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289476|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289477|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289478|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289479|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289480|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289481|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289482|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289483|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289484|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289485|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289486|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289487|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289488|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
290455|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|
289489|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289490|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289491|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289492|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289493|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289494|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289495|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289496|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289497|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289498|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289499|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289500|NCT00121641|O1|Outcome|Open-Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289501|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289502|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289503|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289504|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289505|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289506|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289507|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289508|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289509|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289510|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289511|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289512|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289513|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289514|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289515|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289516|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289517|NCT00121641|E5|Reported Event|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289518|NCT00121641|E4|Reported Event|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289519|NCT00121641|E3|Reported Event|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289520|NCT00121641|E2|Reported Event|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
289521|NCT00121641|E1|Reported Event|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
289522|NCT00121667|B5|Baseline|Total|Total of all reporting groups
289523|NCT00121667|B4|Baseline|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289524|NCT00121667|B3|Baseline|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289525|NCT00121667|B2|Baseline|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289526|NCT00121667|B1|Baseline|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289527|NCT00121667|P4|Participant Flow|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289528|NCT00121667|P3|Participant Flow|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289529|NCT00121667|P2|Participant Flow|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
290456|NCT00123682|E4|Reported Event|Reactive Referral and Self-help Materials|
289530|NCT00121667|P1|Participant Flow|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289531|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289532|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289533|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289534|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289535|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289536|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289537|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289538|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289539|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289540|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289541|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289542|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289543|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289544|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289545|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289546|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289547|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289548|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289549|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289550|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289551|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289552|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289553|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289554|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289555|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289556|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289557|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289558|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289559|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289560|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289561|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289562|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289563|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289564|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
328468|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
289565|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289566|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289567|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289568|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289569|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289570|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289571|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289572|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289573|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289574|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289575|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289576|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289577|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289578|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289579|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289580|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289581|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289582|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289583|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289584|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289585|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289586|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289587|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289588|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289589|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289590|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289591|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289592|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289593|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289594|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289595|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289596|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289597|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289598|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289599|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
290457|NCT00123682|E3|Reported Event|Proactive Referral and Self-help Materials|
289600|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289601|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289602|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289603|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289604|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289605|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289606|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289607|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289608|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289609|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289610|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289611|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289612|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289613|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289614|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289615|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289616|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289617|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289618|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289619|NCT00121667|E4|Reported Event|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289620|NCT00121667|E3|Reported Event|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289621|NCT00121667|E2|Reported Event|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289622|NCT00121667|E1|Reported Event|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
289623|NCT00121719|B15|Baseline|Total|Total of all reporting groups
289624|NCT00121719|B14|Baseline|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289625|NCT00121719|B13|Baseline|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289626|NCT00121719|B12|Baseline|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
290458|NCT00123682|E2|Reported Event|Reactive Referral and Intensive Counseling|
289627|NCT00121719|B11|Baseline|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289628|NCT00121719|B10|Baseline|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289629|NCT00121719|B9|Baseline|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289630|NCT00121719|B8|Baseline|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289631|NCT00121719|B7|Baseline|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289632|NCT00121719|B6|Baseline|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289633|NCT00121719|B5|Baseline|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289634|NCT00121719|B4|Baseline|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289635|NCT00121719|B3|Baseline|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
290459|NCT00123682|E1|Reported Event|Proactive Referral and Intensive Telephone Counseling|
289636|NCT00121719|B2|Baseline|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289637|NCT00121719|B1|Baseline|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289638|NCT00121719|P14|Participant Flow|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289639|NCT00121719|P13|Participant Flow|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289640|NCT00121719|P12|Participant Flow|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289641|NCT00121719|P11|Participant Flow|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289642|NCT00121719|P10|Participant Flow|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289643|NCT00121719|P9|Participant Flow|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289644|NCT00121719|P8|Participant Flow|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289856|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
289645|NCT00121719|P7|Participant Flow|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289646|NCT00121719|P6|Participant Flow|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289647|NCT00121719|P5|Participant Flow|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289648|NCT00121719|P4|Participant Flow|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289649|NCT00121719|P3|Participant Flow|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289650|NCT00121719|P2|Participant Flow|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289651|NCT00121719|P1|Participant Flow|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289652|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted State|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289653|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed State|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289857|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
290460|NCT00123734|B1|Baseline|Group 1|
289654|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289655|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289656|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289657|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289658|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289659|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289660|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289661|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289662|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289663|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289664|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289665|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289666|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289667|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289668|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289669|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289670|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289671|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289858|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
289859|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
289672|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289673|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289674|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289675|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289676|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289677|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289678|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289679|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289844|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
289680|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289681|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289682|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289683|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289684|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289685|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289686|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289687|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289845|NCT00121836|O2|Outcome|First Study Treatment Phase Only|"Capecitabine+Bevacizumab:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle."
289869|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
289688|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289689|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289690|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289691|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289692|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289693|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289694|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289695|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289860|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferencing modality.
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
289901|NCT00122317|P1|Participant Flow|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
289696|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289697|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289698|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289699|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289700|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289701|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289702|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289703|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289846|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
289704|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289705|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289706|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289707|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289708|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289709|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289710|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289711|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289861|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
289902|NCT00122317|O1|Outcome|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
289712|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289713|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289714|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289715|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289716|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289717|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289718|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289719|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289862|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
289863|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
289720|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289721|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289722|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289723|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289724|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289725|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289726|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289727|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289847|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
289728|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289729|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289730|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289731|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289732|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289733|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289734|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289735|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289864|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
289865|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
289736|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289737|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289738|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289739|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289740|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289741|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289742|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289743|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289866|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
289867|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
289744|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289745|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289746|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289747|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289748|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289749|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289750|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289751|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289848|NCT00121836|E1|Reported Event|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
289752|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289753|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289754|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289755|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289756|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289757|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289758|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289759|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289849|NCT00122109|B3|Baseline|Total|Total of all reporting groups
289850|NCT00122109|B2|Baseline|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferncing modality.
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
290461|NCT00123734|P1|Participant Flow|Group 1|
289760|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289761|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289762|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289763|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289764|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289765|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289766|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289767|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289851|NCT00122109|B1|Baseline|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
289903|NCT00122317|E1|Reported Event|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
289768|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289769|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289770|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289771|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289772|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289773|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289774|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289775|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289852|NCT00122109|P2|Participant Flow|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention face-to-face traditional modality as compared to the experimental condition which is the via a videoteleconferencing modality .
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
289868|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
289776|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289777|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289778|NCT00121719|O4|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
289779|NCT00121719|O3|Outcome|25 mg Lenvatinib|Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
289780|NCT00121719|O2|Outcome|12 - 20 mg Lenvatinib|Lenvatinib tablets (at the appropriate dose for a given dose level) were taken orally, once daily on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
289781|NCT00121719|O1|Outcome|0.2 - 6.4 mg Lenvatinib|Lenvatinib tablets (at the appropriate dose for a given dose level) were taken orally, once daily on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
289782|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289783|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289784|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289785|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289794|NCT00121719|O14|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289786|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289787|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289788|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289789|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289790|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289791|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289792|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289793|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289842|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
289795|NCT00121719|O13|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289796|NCT00121719|O12|Outcome|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289797|NCT00121719|O11|Outcome|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289798|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289799|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289800|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289801|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289802|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289803|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289843|NCT00121836|O2|Outcome|First Study Treatment Phase Only|"Capecitabine+Bevacizumab:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle."
289904|NCT00122369|B4|Baseline|Total|Total of all reporting groups
289804|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289805|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289806|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289807|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289808|NCT00121719|O1|Outcome|Lenvatinib|"Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib."
289809|NCT00121719|E14|Reported Event|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289810|NCT00121719|E13|Reported Event|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289811|NCT00121719|E12|Reported Event|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289812|NCT00121719|E11|Reported Event|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
289853|NCT00122109|P1|Participant Flow|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
289813|NCT00121719|E10|Reported Event|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289814|NCT00121719|E9|Reported Event|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289815|NCT00121719|E8|Reported Event|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289816|NCT00121719|E7|Reported Event|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289817|NCT00121719|E6|Reported Event|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and theMTD was determined. An additional 12 participants were treated at the MTD level.
289818|NCT00121719|E5|Reported Event|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289819|NCT00121719|E4|Reported Event|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289820|NCT00121719|E3|Reported Event|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289854|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferencing modality.
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
290066|NCT00122447|O2|Outcome|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
290067|NCT00122447|O1|Outcome|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
289821|NCT00121719|E2|Reported Event|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
289822|NCT00121719|E1|Reported Event|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
289823|NCT00121810|B3|Baseline|Total|Total of all reporting groups
289824|NCT00121810|B2|Baseline|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
289825|NCT00121810|B1|Baseline|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
289826|NCT00121810|P2|Participant Flow|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
289827|NCT00121810|P1|Participant Flow|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
289828|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
289829|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
289830|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
289831|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
289832|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
289833|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
289834|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
289835|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
289836|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
289837|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
289838|NCT00121810|E2|Reported Event|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
289839|NCT00121810|E1|Reported Event|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
289840|NCT00121836|B1|Baseline|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
289841|NCT00121836|P1|Participant Flow|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
289855|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
290068|NCT00122447|O4|Outcome|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
289870|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via the traditional face to face modality as compared to the control condition which is the experimental videoteleconferencing modality.
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
289871|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
289872|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
289873|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
289874|NCT00122109|E2|Reported Event|Face to Face AMT|"The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
289875|NCT00122109|E1|Reported Event|Videoteleconferencing AMT|"The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
289876|NCT00122135|B3|Baseline|Total|Total of all reporting groups
289877|NCT00122135|B2|Baseline|Patients Without VI|Patients who did not receive the Values History prior to their clinic appointment (usual care)
289878|NCT00122135|B1|Baseline|Patients With VI|Patients who filled out the Values History prior to their clinic appointment
289879|NCT00122135|P2|Participant Flow|Patients Without VI|Patients who did not receive the Values Inventory prior to their clinic visit
289880|NCT00122135|P1|Participant Flow|Patients With VI|"patients / surrogates who did receive the Values Inventory prior to their clinic appointment
Values history discussion w/physician & patient/surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
289881|NCT00122135|O2|Outcome|Patients Without VI|Patients who did not receive the Values History prior to their clinic appointment (usual care)
289882|NCT00122135|O1|Outcome|Patients With VI|Patients who filled out the Values History prior to their clinic appointment
289883|NCT00122135|E2|Reported Event|Patients Without VI|"Clinic encounter w/physician & patient and/or surrogate - Patients who did not receive the VI prior to their physician clinic encounter
Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
289884|NCT00122135|E1|Reported Event|Patients With VI|"Clinic encounter w/physician & patient and/or surrogate - Patients who completed the VI prior to their physician clinic encounter
Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
289885|NCT00122187|B3|Baseline|Total|Total of all reporting groups
289886|NCT00122187|B2|Baseline|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
289887|NCT00122187|B1|Baseline|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
289888|NCT00122187|P2|Participant Flow|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
289889|NCT00122187|P1|Participant Flow|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
289890|NCT00122187|O4|Outcome|Usual Care 2nd Site (2b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
289891|NCT00122187|O3|Outcome|Usual Care 1st Site (1b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
289892|NCT00122187|O2|Outcome|Electronic Consult System 2nd Site (2a)|A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
289893|NCT00122187|O1|Outcome|Electronic Consult System 1st Site (1a)|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
289894|NCT00122187|O4|Outcome|Usual Care 2nd Site (2b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
289895|NCT00122187|O3|Outcome|Usual Care 1st Site (1b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
289896|NCT00122187|O2|Outcome|Electronic Consult System 2nd Site (2a)|A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
289897|NCT00122187|O1|Outcome|Electronic Consult System 1st Site (1a)|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
289898|NCT00122187|E2|Reported Event|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
289899|NCT00122187|E1|Reported Event|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
289900|NCT00122317|B1|Baseline|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
290069|NCT00122447|O3|Outcome|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
289905|NCT00122369|B3|Baseline|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient’s anxiety, pain, or worries according to the prescriptions of the script.
289906|NCT00122369|B2|Baseline|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289907|NCT00122369|B1|Baseline|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289908|NCT00122369|P3|Participant Flow|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289909|NCT00122369|P2|Participant Flow|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289910|NCT00122369|P1|Participant Flow|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289911|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289912|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289913|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289914|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289915|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289916|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289917|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289918|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289919|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289920|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289921|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289922|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289923|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289924|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289925|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289926|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
290070|NCT00122447|O2|Outcome|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
290071|NCT00122447|O1|Outcome|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
289927|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289928|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289929|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289930|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289931|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289932|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289933|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289934|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289935|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289936|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289937|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289938|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289939|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289940|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289941|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289942|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289943|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289944|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289945|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289946|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289947|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289948|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289949|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289950|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289951|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289952|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289953|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289954|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289955|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289956|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289957|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289958|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289959|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289960|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289961|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289962|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289963|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289964|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289965|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289966|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289967|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289968|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289969|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289970|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289971|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
290072|NCT00122447|E5|Reported Event|Enrolled, But Not Yet Randomized|Enrolled into study, but not yet randomized to study medication
290073|NCT00122447|E4|Reported Event|Placebo|Aspirin placebo once a day Olmesartan placebo once a day Alpha lipoic acid placebo twice a day
289972|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289973|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289974|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289975|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289976|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289977|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289978|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289979|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289980|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289981|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289982|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289983|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289984|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289985|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289986|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289987|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289988|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289989|NCT00122369|O3|Outcome|Uncertain Diagnosis|"were in the uncertain diagnostic group, either because their result had not been communicated yet (n=54); their LCBB could not be performed for technical reasons and they were waiting for a surgical excision (n=14); or histology showed at risk lesions (n=4) or benign cells with surgery recommended for excision and final diagnosis (n=1)."
289990|NCT00122369|O2|Outcome|Known Malignant Disease|Women who were diagnosed to have malignant disease
289991|NCT00122369|O1|Outcome|Known Benign Disease|Women who were diagnosed to have benign disease
289992|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
289993|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289994|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289995|NCT00122369|E3|Reported Event|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient’s anxiety, pain, or worries according to the prescriptions of the script.
289996|NCT00122369|E2|Reported Event|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
289997|NCT00122369|E1|Reported Event|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
289998|NCT00122382|B3|Baseline|Total|Total of all reporting groups
289999|NCT00122382|B2|Baseline|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290000|NCT00122382|B1|Baseline|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290001|NCT00122382|P3|Participant Flow|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with weekly oral MTX were administered every 28 days from Month 12 to Month 24 (open-label period).
290002|NCT00122382|P2|Participant Flow|Placebo (PLA) + Methotrexate (MTX) (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX) titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12 (end of double blind period).
290003|NCT00122382|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12 (end of double blind period).
290004|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290005|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290006|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290007|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290008|NCT00122382|O2|Outcome|Year 2 Change|Year 2 Change = Day 729 (Month 24) - Day 365 (Month 12)
290009|NCT00122382|O1|Outcome|Year 1 Change|Year 1 Change = Day 365 - Day 1
290010|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290011|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290012|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
290013|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
290014|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
290015|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
290016|NCT00122382|O1|Outcome|ABA + MTX (Open-label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
290017|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
290018|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290019|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
290020|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290021|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
290022|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290023|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
290024|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
290025|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
290026|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
290027|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
290028|NCT00122382|O2|Outcome|Anti-CTLA4-T Antibody Response|
290029|NCT00122382|O1|Outcome|Anti-Abatacept Antibody Response|
290030|NCT00122382|O1|Outcome|ABA + MTX (Open Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
290031|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
290032|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290033|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290074|NCT00122447|E3|Reported Event|Alpha Lipoic Acid|Antioxidant
290075|NCT00122447|E2|Reported Event|Olmesartan|Angiotensin receptor blocker (ARB)
290034|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290035|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290036|NCT00122382|O2|Outcome|ABA + MTX Post-discontinuation|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290037|NCT00122382|O1|Outcome|ABA+ MTX On-treatment|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290038|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290039|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290040|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290041|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290042|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290043|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290044|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290045|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290046|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290047|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290048|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290049|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290050|NCT00122382|E2|Reported Event|Placebo|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
290051|NCT00122382|E1|Reported Event|Abatacept|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
290052|NCT00122447|B5|Baseline|Total|Total of all reporting groups
290053|NCT00122447|B4|Baseline|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
290054|NCT00122447|B3|Baseline|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
290055|NCT00122447|B2|Baseline|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
290056|NCT00122447|B1|Baseline|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
290057|NCT00122447|P4|Participant Flow|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
290058|NCT00122447|P3|Participant Flow|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
290059|NCT00122447|P2|Participant Flow|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
290060|NCT00122447|P1|Participant Flow|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
290061|NCT00122447|O3|Outcome|Diabetes|"After 75g OGTT:
Fasting glucose >=126 mg/dl and 2-hr glucose level >=200 mg/dl"
290062|NCT00122447|O2|Outcome|Impaired Glucose Tolerance (IGT)|"After 75g OGTT:
Fasting glucose <126 mg/dl and 2-hr glucose level 140-199 mg/dl"
290063|NCT00122447|O1|Outcome|Normal Glucose Tolerance (NGT)|Normal fasting glucose (<100 mg/dl) and normal 2-hr glucose level (<140 mg/dl) after 75g OGTT
290064|NCT00122447|O4|Outcome|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
290065|NCT00122447|O3|Outcome|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
290078|NCT00122460|B2|Baseline|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290079|NCT00122460|B1|Baseline|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290080|NCT00122460|P2|Participant Flow|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290081|NCT00122460|P1|Participant Flow|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290082|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290083|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290084|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290085|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290086|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290087|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290088|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290089|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290090|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290091|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290092|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290093|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290094|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290095|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
291350|NCT00125164|B3|Baseline|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
290096|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290097|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290098|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290099|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290100|NCT00122460|E2|Reported Event|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290101|NCT00122460|E1|Reported Event|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
290102|NCT00122681|B3|Baseline|Total|Total of all reporting groups
290103|NCT00122681|B2|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290104|NCT00122681|B1|Baseline|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290105|NCT00122681|P2|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290106|NCT00122681|P1|Participant Flow|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290107|NCT00122681|O2|Outcome|Cervarix Group With HPV-18 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 12-Month persistent infection with HPV-18.
290108|NCT00122681|O1|Outcome|Cervarix Group Without HPV-18 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 12-Month persistent infection with HPV-18.
290109|NCT00122681|O2|Outcome|Cervarix Group With HPV-18 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 12-Month persistent infection with HPV-18.
290110|NCT00122681|O1|Outcome|Cervarix Group Without HPV-18 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 12-Month persistent infection with HPV-18.
290111|NCT00122681|O2|Outcome|Cervarix Group With HPV-18 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-18.
290112|NCT00122681|O1|Outcome|Cervarix Group Without HPV-18 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-18.
290113|NCT00122681|O2|Outcome|Cervarix Group With HPV-18 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-18.
290114|NCT00122681|O1|Outcome|Cervarix Group Without HPV-18 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-18.
290115|NCT00122681|O2|Outcome|Cervarix Group With HPV-16 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, with 12 Month persistent infection with HPV-16.
290116|NCT00122681|O1|Outcome|Cervarix Group Without HPV-16 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, without 12 Month persistent infection with HPV-16.
290117|NCT00122681|O2|Outcome|Cervarix Group With HPV-16 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, with 12 Month persistent infection with HPV-16.
290118|NCT00122681|O1|Outcome|Cervarix Group Without HPV-16 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, without 12 Month persistent infection with HPV-16.
290119|NCT00122681|O2|Outcome|Cervarix Group With HPV-16 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-16.
290120|NCT00122681|O1|Outcome|Cervarix Group Without HPV-16 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-16.
290121|NCT00122681|O2|Outcome|Cervarix Group With HPV-16 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-16.
291392|NCT00125164|O1|Outcome|Untreated|Observational Group
290122|NCT00122681|O1|Outcome|Cervarix Group Without HPV-16 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-16.
290123|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290124|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290125|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290126|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290127|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290128|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290129|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290130|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290131|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290132|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290133|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290134|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290135|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290136|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290137|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290138|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290139|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290140|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290141|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290142|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290143|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290144|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290145|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290146|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290147|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290148|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290149|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290150|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290151|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290152|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290153|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290154|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290155|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290156|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290157|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290158|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290159|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290160|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290161|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290162|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290163|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290164|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290165|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290166|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290167|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290168|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290169|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290170|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290171|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290172|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290173|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290174|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290175|NCT00122681|E2|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
290176|NCT00122681|E1|Reported Event|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
290177|NCT00122954|B3|Baseline|Total|Total of all reporting groups
290178|NCT00122954|B2|Baseline|Fish Oil Concentrate|Participants receiving fish oil concentrate at a daily dose of 6 grams (2.1 grams EPA and 1.5 grams DHA)
290179|NCT00122954|B1|Baseline|Placebo|Participants receiving soybean placebo with 1% fish oil at a daily dose of 6 grams.
290180|NCT00122954|P2|Participant Flow|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
290181|NCT00122954|P1|Participant Flow|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
290182|NCT00122954|O2|Outcome|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
290183|NCT00122954|O1|Outcome|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
290184|NCT00122954|O2|Outcome|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
290185|NCT00122954|O1|Outcome|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
290186|NCT00122954|E2|Reported Event|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
290187|NCT00122954|E1|Reported Event|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
290188|NCT00122980|B3|Baseline|Total|Total of all reporting groups
290189|NCT00122980|B2|Baseline|Transfusion/Chelation|2: The Transfusion/Chelation group includes participants randomized to Standard Treatment. Participants continued to receive monthly blood transfusions designed to maintain ≤30% HbS, with local discretion regarding type of transfusion (e.g., simple or erythrocytapheresis). These participants also received daily iron chelation typically with deferasirox (Exjade®). Children already on chelation initially maintained their current dose, while those starting deferasirox received 20 mg/kg/day, with dose escalation in both groups as indicated and tolerated.
290190|NCT00122980|B1|Baseline|Hydroxyurea/Phlebotomy|1: The Hydroxyurea/Phlebotomy group includes participants randomized to Alternative Treatment. Participants commenced hydroxyurea treatment at 20 mg/kg/day with step-wise escalation to maximum tolerated dose (MTD) defined by mild myelosuppression (absolute neutrophil count 2-4 x 10^9/L). Transfusions continued for 4-9 months during an overlap phase using a modified schedule to protect against recurrent stroke during hydroxyurea dose escalation. Once MTD was reached and transfusions were discontinued, phlebotomy commenced with a target of 10 mL/kg (maximum volume 500mL) blood removed monthly to reduce iron burden. Lower phlebotomy volumes (5 mL/kg) were recommended if participants were excessively anemic (hemoglobin concentration 7.0-7.9 gm/dL); phlebotomy was not performed if the hemoglobin level was <7.0 gm/dL. The total duration of study treatment was 30 months after randomization, with a final study visit scheduled 6-months after discontinuation of study treatments.
290191|NCT00122980|P2|Participant Flow|Transfusion/Chelation|2: The Transfusion/Chelation group includes participants randomized to Standard Treatment. Participants continued to receive monthly blood transfusions designed to maintain ≤30% HbS, with local discretion regarding type of transfusion (e.g., simple or erythrocytapheresis). These participants also received daily iron chelation typically with deferasirox (Exjade®). Children already on chelation initially maintained their current dose, while those starting deferasirox received 20 mg/kg/day, with dose escalation in both groups as indicated and tolerated.
328469|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
290192|NCT00122980|P1|Participant Flow|Hydroxyurea/Phlebotomy|1: The Hydroxyurea/Phlebotomy group includes participants randomized to Alternative Treatment. Participants commenced hydroxyurea treatment at 20 mg/kg/day with step-wise escalation to maximum tolerated dose (MTD) defined by mild myelosuppression (absolute neutrophil count 2-4 x 10^9/L). Transfusions continued for 4-9 months during an overlap phase using a modified schedule to protect against recurrent stroke during hydroxyurea dose escalation. Once MTD was reached and transfusions were discontinued, phlebotomy commenced with a target of 10 mL/kg (maximum volume 500mL) blood removed monthly to reduce iron burden. Lower phlebotomy volumes (5 mL/kg) were recommended if participants were excessively anemic (hemoglobin concentration 7.0-7.9 gm/dL); phlebotomy was not performed if the hemoglobin level was <7.0 gm/dL. The total duration of study treatment was 30 months after randomization, with a final study visit scheduled 6-months after discontinuation of study treatments.
290193|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
290194|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
290195|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
290196|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
290197|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
290198|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
290199|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
290200|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
290201|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
290202|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
290203|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
290204|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
290205|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
290206|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
290207|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
290208|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
290209|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
290210|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
290211|NCT00122980|E2|Reported Event|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
290212|NCT00122980|E1|Reported Event|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
290213|NCT00123123|B4|Baseline|Total|Total of all reporting groups
290214|NCT00123123|B3|Baseline|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
290215|NCT00123123|B2|Baseline|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
290216|NCT00123123|B1|Baseline|Placebo|Vehicle control twice a day (oral rinse)
290217|NCT00123123|P3|Participant Flow|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
290218|NCT00123123|P2|Participant Flow|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
290219|NCT00123123|P1|Participant Flow|Placebo|Vehicle control twice a day (oral rinse)
290220|NCT00123123|O3|Outcome|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
290221|NCT00123123|O2|Outcome|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
290222|NCT00123123|O1|Outcome|Placebo|Vehicle control twice a day (oral rinse)
290223|NCT00123123|O3|Outcome|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
290224|NCT00123123|O2|Outcome|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
290225|NCT00123123|O1|Outcome|Placebo|Vehicle control twice a day (oral rinse)
290226|NCT00123123|E3|Reported Event|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
290227|NCT00123123|E2|Reported Event|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
290228|NCT00123123|E1|Reported Event|Placebo|Vehicle control twice a day (oral rinse)
290229|NCT00123162|B3|Baseline|Total|Total of all reporting groups
290230|NCT00123162|B2|Baseline|Placebo|A single vaginal dose of placebo.
290231|NCT00123162|B1|Baseline|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
290232|NCT00123162|P2|Participant Flow|Placebo|A single vaginal dose of placebo.
290233|NCT00123162|P1|Participant Flow|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
290234|NCT00123162|O2|Outcome|Placebo|A single vaginal dose of placebo.
290235|NCT00123162|O1|Outcome|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
290236|NCT00123162|O2|Outcome|Placebo|A single vaginal dose of placebo.
290237|NCT00123162|O1|Outcome|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
290238|NCT00123162|E2|Reported Event|Placebo|A single vaginal dose of placebo.
290239|NCT00123162|E1|Reported Event|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
290240|NCT00123409|B3|Baseline|Total|Total of all reporting groups
290241|NCT00123409|B2|Baseline|Usual Care|"Usual Care
Usual Care: Usual care"
290242|NCT00123409|B1|Baseline|Telephone Disease Management|"Telephone Based care management for reducing alcohol use
Telephone disease management: Telephone based care management"
290243|NCT00123409|P2|Participant Flow|Arm 2|"Usual Care
Usual Care: Usual care"
290244|NCT00123409|P1|Participant Flow|Arm 1|"Telephone Based care management for reducing alcohol use
Telephone disease management: Telephone based care management"
290245|NCT00123409|O2|Outcome|Arm 2|"Usual Care
Usual Care: Usual care"
290462|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
290246|NCT00123409|O1|Outcome|Arm 1|"Telephone Based care management for reducing alcohol use
Telephone disease management: Telephone based care management"
290247|NCT00123409|O2|Outcome|Usual Care|"Usual Care
Usual Care: Usual care"
290248|NCT00123409|O1|Outcome|Telephone Based Management|"Telephone Based Management used to reduce alcohol misuse
Telephone disease management: Telephone based care management"
290249|NCT00123409|E2|Reported Event|Arm 2|"Usual Care
Usual Care: Usual care"
290250|NCT00123409|E1|Reported Event|Arm 1|"Telephone Based care management for reducing alcohol use
Telephone disease management: Telephone based care management"
290251|NCT00123422|B4|Baseline|Total|Total of all reporting groups
290252|NCT00123422|B3|Baseline|Exercise|"Exercise training
Exercise: exercise training"
290253|NCT00123422|B2|Baseline|Heliox|"Exercise training with helium oxygen combination
Heliox: exercise training with a helium oxygen combination"
290254|NCT00123422|B1|Baseline|Breathing Retraining|"Exercise training with computerized training program
Breathing retraining: exercise training with computerized training program"
290255|NCT00123422|P3|Participant Flow|Exercise|"Exercise training
Exercise: exercise training"
290256|NCT00123422|P2|Participant Flow|Heliox|"Exercise training with helium oxygen combination
Heliox: exercise training with a helium oxygen combination"
290257|NCT00123422|P1|Participant Flow|Breathing Retraining|"Exercise training with computerized training program
Breathing retraining: exercise training with computerized training program"
290258|NCT00123422|O3|Outcome|Exercise|"Exercise training
Exercise: exercise training"
290259|NCT00123422|O2|Outcome|Heliox|"Exercise training with helium oxygen combination
Heliox: exercise training with a helium oxygen combination"
290260|NCT00123422|O1|Outcome|Breathing Retraining|"Exercise training with computerized training program
Breathing retraining: exercise training with computerized training program"
290261|NCT00123422|O3|Outcome|Exercise|"Exercise training
Exercise: exercise training"
290262|NCT00123422|O2|Outcome|Heliox|"Exercise training with helium oxygen combination
Heliox: exercise training with a helium oxygen combination"
290263|NCT00123422|O1|Outcome|Breathing Retraining|"Exercise training with computerized training program
Breathing retraining: exercise training with computerized training program"
290264|NCT00123422|E3|Reported Event|Exercise|"Exercise training
Exercise: exercise training"
290265|NCT00123422|E2|Reported Event|Heliox|"Exercise training with helium oxygen combination
Heliox: exercise training with a helium oxygen combination"
290266|NCT00123422|E1|Reported Event|Breathing Retraining|"Exercise training with computerized training program
Breathing retraining: exercise training with computerized training program"
290267|NCT00123474|B5|Baseline|Total|Total of all reporting groups
290268|NCT00123474|B4|Baseline|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290269|NCT00123474|B3|Baseline|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290270|NCT00123474|B2|Baseline|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290271|NCT00123474|B1|Baseline|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290272|NCT00123474|P4|Participant Flow|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290273|NCT00123474|P3|Participant Flow|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290274|NCT00123474|P2|Participant Flow|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290275|NCT00123474|P1|Participant Flow|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290276|NCT00123474|O3|Outcome|Total|Participants received study drug in any schedule or total daily dose until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290277|NCT00123474|O2|Outcome|Other Treatment Groups|Participants participated in all other treatment arms until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
290278|NCT00123474|O1|Outcome|100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290279|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290280|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290281|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290463|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
290464|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
290282|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290283|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290284|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290285|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290286|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290287|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290288|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290289|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290290|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290291|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290292|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290293|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290294|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290295|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290296|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290297|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290298|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290299|NCT00123474|O4|Outcome|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
290300|NCT00123474|O3|Outcome|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
290301|NCT00123474|O2|Outcome|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
290302|NCT00123474|O1|Outcome|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290303|NCT00123474|O4|Outcome|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
290304|NCT00123474|O3|Outcome|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
290305|NCT00123474|O2|Outcome|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
290306|NCT00123474|O1|Outcome|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290465|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
328470|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
290307|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290308|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290309|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290310|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290311|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290312|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290313|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290314|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290315|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290316|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290317|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290318|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290319|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290320|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290321|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290322|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290323|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290324|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290325|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290326|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290327|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290328|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290329|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290330|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
291393|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
290331|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290332|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290333|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290334|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290335|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290336|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290337|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290338|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290339|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290340|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290341|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290342|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290343|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290344|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290345|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290346|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290347|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290348|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290349|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290350|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290351|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290352|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
291394|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
290353|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290354|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290355|NCT00123474|O4|Outcome|Dasatinib 140 mg Total Daily Dose|Participants received 140 mg as a total daily dose (either 70 mg BID or 140 mg QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290356|NCT00123474|O3|Outcome|Dasatinib 100 mg Total Daily Dose|Participants received 100 mg as a total daily dose (either 50 mg BID or 100 mg QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290357|NCT00123474|O2|Outcome|Dasatinib BID|Participants received either 50 mg BID or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
290358|NCT00123474|O1|Outcome|Dasatinib QD|Participants received either 100 mg QD or 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290359|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) dasatinib until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290360|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) dasatinib until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
290361|NCT00123474|E4|Reported Event|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
290362|NCT00123474|E3|Reported Event|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
290363|NCT00123474|E2|Reported Event|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
290364|NCT00123474|E1|Reported Event|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
290365|NCT00123487|B3|Baseline|Total|Total of all reporting groups
290366|NCT00123487|B2|Baseline|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290367|NCT00123487|B1|Baseline|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290368|NCT00123487|P2|Participant Flow|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290369|NCT00123487|P1|Participant Flow|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290370|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290371|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290372|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290373|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290374|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290375|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290376|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290377|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290378|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290379|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290380|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290381|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290382|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290383|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290384|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290385|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290386|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290387|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290388|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290389|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290390|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290391|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290392|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290393|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290394|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290395|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290396|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290397|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290398|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290399|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290400|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290401|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290402|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290403|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290404|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
290405|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290466|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
328471|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
290406|NCT00123487|E2|Reported Event|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290407|NCT00123487|E1|Reported Event|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
290408|NCT00123604|B3|Baseline|Total|Total of all reporting groups
290409|NCT00123604|B2|Baseline|Carvedilol|Carvedilol, orally, 25mg, twice daily for five months
290410|NCT00123604|B1|Baseline|Metoprolol|Metoprolol, orally, 200mg, twice daily for five months
290411|NCT00123604|P2|Participant Flow|Carvedilol|Carvedilol, orally, 25 mg, once daily
290412|NCT00123604|P1|Participant Flow|Metoprolol|Metoprolol, orally, 200 mg, once daily
290413|NCT00123604|O2|Outcome|Metoprolol|Metoprolol, orally, 200mg, once daily
290414|NCT00123604|O1|Outcome|Carvedilol|Carvedilol, orally, 25mg, once daily
290415|NCT00123604|E2|Reported Event|Carvedilol|Carvedilol, orally, 25 mg, once daily
290416|NCT00123604|E1|Reported Event|Metoprolol|Metoprolol, orally, 200mg, once daily
290417|NCT00123630|B3|Baseline|Total|Total of all reporting groups
290418|NCT00123630|B2|Baseline|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
290419|NCT00123630|B1|Baseline|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
290420|NCT00123630|P2|Participant Flow|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
290421|NCT00123630|P1|Participant Flow|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
290422|NCT00123630|O2|Outcome|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
290423|NCT00123630|O1|Outcome|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
290424|NCT00123630|E2|Reported Event|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
290425|NCT00123630|E1|Reported Event|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
290426|NCT00123643|B3|Baseline|Total|Total of all reporting groups
290427|NCT00123643|B2|Baseline|Glyburide|
290428|NCT00123643|B1|Baseline|Rosiglitazone|
290429|NCT00123643|P2|Participant Flow|Glyburide|
290430|NCT00123643|P1|Participant Flow|Rosiglitazone|
290431|NCT00123643|O2|Outcome|Glyburide|
290432|NCT00123643|O1|Outcome|Rosiglitazone|
290433|NCT00123643|E2|Reported Event|Glyburide|
290434|NCT00123643|E1|Reported Event|Rosiglitazone|
290435|NCT00123682|B5|Baseline|Total|Total of all reporting groups
290436|NCT00123682|B4|Baseline|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
290437|NCT00123682|B3|Baseline|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
290438|NCT00123682|B2|Baseline|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
290439|NCT00123682|B1|Baseline|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
290440|NCT00123682|P4|Participant Flow|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
290441|NCT00123682|P3|Participant Flow|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
290442|NCT00123682|P2|Participant Flow|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
290443|NCT00123682|P1|Participant Flow|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
290444|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
290445|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
290446|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
290447|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
290448|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
290449|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
290450|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
290451|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
290452|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|
290453|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|
290467|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
290468|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
290469|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
290470|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
290471|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
290472|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
290473|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
290474|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
290475|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
290476|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
290477|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
290478|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
290479|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
290480|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
290481|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
290482|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
290483|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
290484|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
290485|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
290486|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
290487|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
290488|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
290489|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
290490|NCT00123734|E1|Reported Event|Group 1|
290491|NCT00123955|B3|Baseline|Total|Total of all reporting groups
290492|NCT00123955|B2|Baseline|Placebo|"Placebo
Placebo: Placebo tablet daily for 9 months"
290493|NCT00123955|B1|Baseline|Spironolactone|"Spironolactone
Spironolactone: 25mg tablet daily for 9 months"
290494|NCT00123955|P2|Participant Flow|Placebo|"Placebo
Placebo: Placebo tablet daily for 9 months"
290495|NCT00123955|P1|Participant Flow|Spironolactone|"Spironolactone
Spironolactone: 25mg tablet daily for 9 months"
290496|NCT00123955|O2|Outcome|Placebo|"Placebo
Placebo: Placebo tablet daily for 9 months"
290497|NCT00123955|O1|Outcome|Spironolactone|"Spironolactone
Spironolactone: 25mg tablet daily for 9 months"
290498|NCT00123955|E2|Reported Event|Placebo|"Placebo
Placebo: Placebo tablet daily for 9 months"
290499|NCT00123955|E1|Reported Event|Spironolactone|"Spironolactone
Spironolactone: 25mg tablet daily for 9 months"
290500|NCT00117156|B1|Baseline|Fludarabine and Rituximab|"Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab"
290501|NCT00117156|P1|Participant Flow|Fludarabine and Rituximab|"Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab"
290502|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab"
290503|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab"
290504|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab"
290505|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab"
290556|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
290557|NCT00117338|O2|Outcome|Placebo|
290558|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
290559|NCT00117338|E2|Reported Event|Placebo|
290560|NCT00117338|E1|Reported Event|Montelukast Intravenous (IV) 5.25 mg|
290506|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab"
290507|NCT00117156|E1|Reported Event|Fludarabine and Rituximab|"Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab"
290508|NCT00117286|B3|Baseline|Total|Total of all reporting groups
290509|NCT00117286|B2|Baseline|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
290510|NCT00117286|B1|Baseline|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
290511|NCT00117286|P2|Participant Flow|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
290512|NCT00117286|P1|Participant Flow|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
290513|NCT00117286|O2|Outcome|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
290514|NCT00117286|O1|Outcome|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
290515|NCT00117286|O2|Outcome|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
290516|NCT00117286|O1|Outcome|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
290517|NCT00117286|E2|Reported Event|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
290518|NCT00117286|E1|Reported Event|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
290519|NCT00117312|B5|Baseline|Total|Total of all reporting groups
290520|NCT00117312|B4|Baseline|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290521|NCT00117312|B3|Baseline|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290522|NCT00117312|B2|Baseline|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290523|NCT00117312|B1|Baseline|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290524|NCT00117312|P4|Participant Flow|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290525|NCT00117312|P3|Participant Flow|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290526|NCT00117312|P2|Participant Flow|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290527|NCT00117312|P1|Participant Flow|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290528|NCT00117312|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290529|NCT00117312|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290530|NCT00117312|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290531|NCT00117312|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290532|NCT00117312|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290533|NCT00117312|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290534|NCT00117312|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290535|NCT00117312|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290536|NCT00117312|E4|Reported Event|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290537|NCT00117312|E3|Reported Event|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290538|NCT00117312|E2|Reported Event|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290539|NCT00117312|E1|Reported Event|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290540|NCT00117338|B3|Baseline|Total|Total of all reporting groups
290541|NCT00117338|B2|Baseline|Placebo|
290542|NCT00117338|B1|Baseline|Montelukast Intravenous (IV) 5.25 mg|
290543|NCT00117338|P2|Participant Flow|Placebo|
290544|NCT00117338|P1|Participant Flow|Montelukast Intravenous (IV) 5.25 mg|
290545|NCT00117338|O2|Outcome|Placebo|
290546|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
290547|NCT00117338|O2|Outcome|Placebo|
290548|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
290549|NCT00117338|O2|Outcome|Placebo|
290550|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
290551|NCT00117338|O2|Outcome|Placebo|
290552|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
290553|NCT00117338|O2|Outcome|Placebo|
290554|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
290555|NCT00117338|O2|Outcome|Placebo|
290563|NCT00117559|B1|Baseline|TEL-CBT|"Telehealth, problem solving based treatment
Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
290564|NCT00117559|P2|Participant Flow|Treatment as Usual|Control group
290565|NCT00117559|P1|Participant Flow|TEL-CBT|"Telehealth, problem solving based treatment
Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
290566|NCT00117559|O2|Outcome|Treatment as Usual|Control group
290567|NCT00117559|O1|Outcome|TEL-CBT|"Telehealth, problem solving based treatment
Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
290568|NCT00117559|E2|Reported Event|Treatment as Ususal|Control group
290569|NCT00117559|E1|Reported Event|TEL-CBT|"Telehealth, problem solving based treatment
Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
290570|NCT00117585|B1|Baseline|Arm 1|"Stepped intervention consisting of three treatment phases
Treatment 1 :
Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist
Treatment 2 : Fludrocortisone Salt tablets
Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
290571|NCT00117585|P1|Participant Flow|Arm 1|"Stepped intervention consisting of three treatment phases
Treatment 1 :
Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist
Treatment 2 : Fludrocortisone Salt tablets
Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
290572|NCT00117585|O1|Outcome|Arm 1|"Stepped intervention consisting of three treatment phases
Treatment 1 :
Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist
Treatment 2 : Fludrocortisone Salt tablets
Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
290573|NCT00117585|E1|Reported Event|Arm 1|"Stepped intervention consisting of three treatment phases
Treatment 1 :
Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist
Treatment 2 : Fludrocortisone Salt tablets
Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
290574|NCT00117598|B4|Baseline|Total|Total of all reporting groups
290575|NCT00117598|B3|Baseline|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:
Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;
Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;
Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;
Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;
Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;
Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;
Prednisone 40 (20-60) mg/m^2 PO daily or every other day;
Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
290576|NCT00117598|B2|Baseline|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290577|NCT00117598|B1|Baseline|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290578|NCT00117598|P5|Participant Flow|Investigator's Choice Then Temsirolimus 175/75 mg|Participants received 1 single-agent treatment chosen by investigator until treatment cross over allowed (via Protocol Amendment 5), then temsirolimus 175 mg IV once weekly for 3 weeks; then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290579|NCT00117598|P4|Participant Flow|Temsirolimus 175/25 mg Then 75 mg|Temsirolimus 175 mg administered IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until treatment cross over allowed (via Protocol Amendment 5), then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290580|NCT00117598|P3|Participant Flow|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:
Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;
Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;
Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;
Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;
Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;
Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;
Prednisone 40 (20-60) mg/m^2 PO daily or every other day;
Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
290581|NCT00117598|P2|Participant Flow|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290582|NCT00117598|P1|Participant Flow|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290583|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:
Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;
Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;
Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;
Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;
Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;
Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;
Prednisone 40 (20-60) mg/m^2 PO daily or every other day;
Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
290584|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290585|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290586|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:
Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;
Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;
Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;
Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;
Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;
Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;
Prednisone 40 (20-60) mg/m^2 PO daily or every other day;
Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
290587|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290588|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290589|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:
Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;
Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;
Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;
Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;
Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;
Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;
Prednisone 40 (20-60) mg/m^2 PO daily or every other day;
Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
290590|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290591|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290592|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:
Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;
Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;
Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;
Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;
Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;
Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;
Prednisone 40 (20-60) mg/m^2 PO daily or every other day;
Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
290593|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290594|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290595|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:
Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;
Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;
Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;
Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;
Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;
Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;
Prednisone 40 (20-60) mg/m^2 PO daily or every other day;
Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
290596|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290597|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290598|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:
Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;
Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;
Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;
Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;
Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;
Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;
Prednisone 40 (20-60) mg/m^2 PO daily or every other day;
Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
290599|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290600|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290714|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290601|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:
Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;
Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;
Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;
Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;
Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;
Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;
Prednisone 40 (20-60) mg/m^2 PO daily or every other day;
Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
290602|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290603|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290604|NCT00117598|E5|Reported Event|Investigator's Choice Then Temsirolimus 175/75 mg|Participants received 1 single-agent treatment chosen by investigator until treatment cross over allowed (via Protocol Amendment 5), then temsirolimus 175 mg IV once weekly for 3 weeks; then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. AEs presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290605|NCT00117598|E4|Reported Event|Temsirolimus 175/25 mg Then 75 mg|Temsirolimus 175 mg administered IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until treatment cross over allowed (via Protocol Amendment 5), then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Adverse events (AEs) presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290606|NCT00117598|E3|Reported Event|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:
Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;
Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;
Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;
Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;
Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;
Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;
Prednisone 40 (20-60) mg/m^2 PO daily or every other day;
Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
290607|NCT00117598|E2|Reported Event|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
290608|NCT00117598|E1|Reported Event|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Includes participants who received Temsirolimus 175/75 mg prior to crossover (Protocol Amendment 5).
290609|NCT00117637|B3|Baseline|Total|Total of all reporting groups
290610|NCT00117637|B2|Baseline|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290611|NCT00117637|B1|Baseline|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290612|NCT00117637|P2|Participant Flow|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290613|NCT00117637|P1|Participant Flow|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290614|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290615|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290715|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290616|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290617|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290618|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290619|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290620|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290621|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290622|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290623|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290624|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290625|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290626|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290627|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290628|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290629|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
292653|NCT00132314|O1|Outcome|Injectable Risperidone|long-acting injectable risperidone
290630|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290631|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290632|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290633|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290634|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290635|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290636|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290637|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290638|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290639|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290640|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290641|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290642|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290643|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290716|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290644|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290645|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290646|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290647|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290648|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290649|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290650|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290651|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290652|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290653|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290654|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290655|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290656|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290657|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290717|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290658|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290659|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290660|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290661|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290662|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290663|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290664|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290665|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290666|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290667|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290668|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290669|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290670|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290671|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290718|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290672|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290673|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290674|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290675|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290676|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290677|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290678|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290679|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290680|NCT00117637|E4|Reported Event|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290681|NCT00117637|E3|Reported Event|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290682|NCT00117637|E2|Reported Event|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
290683|NCT00117637|E1|Reported Event|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
290684|NCT00117676|B3|Baseline|Total|Total of all reporting groups
290685|NCT00117676|B2|Baseline|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290686|NCT00117676|B1|Baseline|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290687|NCT00117676|P2|Participant Flow|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period.
290805|NCT00117806|O1|Outcome|Supported Employment|Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury.
290688|NCT00117676|P1|Participant Flow|TDF-TDF|Tenofovir disoproxil fumarate (TDF) 300 mg plus placebo to match adefovir dipivoxil (ADV) (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC; as part of FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet) to their treatment regimen in the open-label period.
290689|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290690|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290691|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290692|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290693|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290694|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290695|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290696|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290697|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290698|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290699|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290700|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290701|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290702|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290703|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290704|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290705|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290706|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290707|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290708|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290709|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290710|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290711|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290712|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290713|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290719|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290720|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290721|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290722|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290723|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
290724|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
290725|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290726|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290727|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290728|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290729|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290730|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290731|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290732|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290733|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290734|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290735|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290736|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290737|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290738|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290739|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290740|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290741|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290742|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290743|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290744|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
291033|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
290745|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290746|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290747|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290748|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290749|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290750|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290751|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290752|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290753|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290754|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290755|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290756|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290757|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290758|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290759|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290760|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290761|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290762|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290763|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290764|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290765|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290766|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290767|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290768|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290769|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
290770|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
292654|NCT00132314|E2|Reported Event|Oral Antipsychotic|oral antipsychotic medication
290771|NCT00117676|E3|Reported Event|Open-Label TDF|"Adverse events for this reporting group include those occurring during the open-label TDF 300 mg period (Week 49 up to Week 384), regardless of which group they were randomized to in the double-blind period.
TDF 300 mg+ADV placebo or ADV 10 mg+TDF placebo (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period."
290772|NCT00117676|E2|Reported Event|Double-Blind ADV|"Adverse events this reporting group include those occurring in the ADV-TDF group during the double-blind period only (baseline to Week 48).
ADV 10 mg plus placebo to match TDF (double-blind period)."
290773|NCT00117676|E1|Reported Event|Double-Blind TDF|"Adverse events this reporting group include those occurring in the TDF-TDF group during the double-blind period only (baseline to Week 48).
TDF 300 mg plus placebo to match ADV (double-blind period)."
290774|NCT00117715|B1|Baseline|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
290775|NCT00117715|P1|Participant Flow|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
290776|NCT00117715|O1|Outcome|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
290777|NCT00117715|O1|Outcome|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
290778|NCT00117715|O1|Outcome|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
290779|NCT00117715|E1|Reported Event|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
290780|NCT00117793|B1|Baseline|Entire Study Population|Includes participants randomized to receive PIN first and VASS first.
290781|NCT00117793|P1|Participant Flow|Entire Study Population|"This is a randomized cross-over study. Each participant wore both study prostheses: (1) a total surface bearing socket with a vacuum-assisted suspension system (VASS) and (2) a modified patellar tendon bearing socket with a pin lock suspension system (PIN).
Subjects were randomized, provided with one of two study prostheses, and asked to wear it for three weeks. Data was then collected during laboratory visit one, and, following one more week of wearing the first study prosthesis, during laboratory visit two. Participants were then provided with the second study intervention and asked to wear it for three weeks. Data was then collected during laboratory visit three, and, following one more week of wearing the second study intervention, during laboratory visit four.
Data was not collected on the order in which participants received each study intervention"
290782|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
290783|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
290784|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
290785|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
290786|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
290787|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
290788|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
290789|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
290790|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
290791|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
290792|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
290793|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
290794|NCT00117793|E1|Reported Event|Entire Study Population|Includes participants randomized to receive PIN first and VASS first.
290795|NCT00117806|B3|Baseline|Total|Total of all reporting groups
290796|NCT00117806|B2|Baseline|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
290797|NCT00117806|B1|Baseline|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury
Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
290798|NCT00117806|P2|Participant Flow|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
290799|NCT00117806|P1|Participant Flow|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury
Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
290800|NCT00117806|O2|Outcome|Arm 2|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
290801|NCT00117806|O1|Outcome|Arm 1|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury
Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
290802|NCT00117806|O2|Outcome|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
290803|NCT00117806|O1|Outcome|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury
Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
290804|NCT00117806|O2|Outcome|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
290806|NCT00117806|E2|Reported Event|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
290807|NCT00117806|E1|Reported Event|Supported Employment|"SCI-VIP: supported employment implemented for veterans with spinal cord injury
Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury."
290808|NCT00117845|B1|Baseline|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
290809|NCT00117845|P1|Participant Flow|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
290810|NCT00117845|O1|Outcome|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
290811|NCT00117845|O1|Outcome|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
290812|NCT00117845|E1|Reported Event|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
290813|NCT00117949|B5|Baseline|Total|Total of all reporting groups
290814|NCT00117949|B4|Baseline|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290815|NCT00117949|B3|Baseline|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290816|NCT00117949|B2|Baseline|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290817|NCT00117949|B1|Baseline|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290818|NCT00117949|P4|Participant Flow|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290819|NCT00117949|P3|Participant Flow|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290820|NCT00117949|P2|Participant Flow|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290821|NCT00117949|P1|Participant Flow|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290822|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290823|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290824|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290825|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290826|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290827|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290828|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290829|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290830|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290831|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290832|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290833|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290834|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290835|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290836|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290837|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290838|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290839|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290840|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290841|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290842|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290843|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290844|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290845|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290846|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290847|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290848|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290849|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290850|NCT00117949|E4|Reported Event|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
290851|NCT00117949|E3|Reported Event|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
290852|NCT00117949|E2|Reported Event|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
290853|NCT00117949|E1|Reported Event|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
290854|NCT00117962|B3|Baseline|Total|Total of all reporting groups
290855|NCT00117962|B2|Baseline|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
290856|NCT00117962|B1|Baseline|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
290857|NCT00117962|P2|Participant Flow|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
290858|NCT00117962|P1|Participant Flow|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
290859|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
290860|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
290958|NCT00124072|B2|Baseline|Simvastatin 80 mg + Folic Acid and B12|Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
290861|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
290862|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
290863|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
290864|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
290865|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
290866|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
290867|NCT00117962|E2|Reported Event|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
290868|NCT00117962|E1|Reported Event|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
290869|NCT00117988|B1|Baseline|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
290870|NCT00117988|P1|Participant Flow|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
290871|NCT00117988|O1|Outcome|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
290872|NCT00117988|E1|Reported Event|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
290873|NCT00118040|B4|Baseline|Total|Total of all reporting groups
290874|NCT00118040|B3|Baseline|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290875|NCT00118040|B2|Baseline|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290876|NCT00118040|B1|Baseline|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290877|NCT00118040|P3|Participant Flow|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290878|NCT00118040|P2|Participant Flow|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290879|NCT00118040|P1|Participant Flow|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290880|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290881|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290882|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290883|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290884|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290885|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290886|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290887|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290888|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
291034|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
290889|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290890|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290891|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290892|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290893|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290894|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290895|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290896|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290897|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290898|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290899|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290900|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290901|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290902|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290903|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290904|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290905|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290906|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290907|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290908|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290909|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290910|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290911|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290912|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290913|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290914|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290915|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290916|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290959|NCT00124072|B1|Baseline|Simvastatin 20 mg + Folic Acid and B12|Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
290917|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290918|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290919|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290920|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290921|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290922|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290923|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290924|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290925|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290926|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290927|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290928|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290929|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290930|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290931|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290932|NCT00118040|O4|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
290933|NCT00118040|O3|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290934|NCT00118040|O2|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290935|NCT00118040|O1|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
290936|NCT00118040|E3|Reported Event|Arm III (Placebo)|"Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
laboratory biomarker analysis: Correlative studies
placebo: Given orally
therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
pharmacological study: Correlative studies"
290937|NCT00118040|E2|Reported Event|Arm II (Higher Dose Genistein)|"Patients receive oral genistein as in arm I but at a higher dose. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
genistein: Given orally
laboratory biomarker analysis: Correlative studies
therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
pharmacological study: Correlative studies"
290938|NCT00118040|E1|Reported Event|Arm I (Lower Dose Genistein)|"Patients receive oral genistein twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
genistein: Given orally
laboratory biomarker analysis: Correlative studies
therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
pharmacological study: Correlative studies"
290939|NCT00118053|B1|Baseline|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.
Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.
If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
291032|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
290940|NCT00118053|P1|Participant Flow|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.
Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.
If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
290941|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.
Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.
If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
290942|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.
Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.
If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
290943|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.
Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.
If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
290944|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.
Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.
If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
290945|NCT00118053|E1|Reported Event|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.
Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.
If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
290946|NCT00124020|B3|Baseline|Total|Total of all reporting groups
290947|NCT00124020|B2|Baseline|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
290948|NCT00124020|B1|Baseline|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
290949|NCT00124020|P2|Participant Flow|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
290950|NCT00124020|P1|Participant Flow|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
290951|NCT00124020|O2|Outcome|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
290952|NCT00124020|O1|Outcome|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
290953|NCT00124020|E2|Reported Event|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
290954|NCT00124020|E1|Reported Event|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
290955|NCT00124072|B5|Baseline|Total|Total of all reporting groups
290956|NCT00124072|B4|Baseline|Simvastatin 80 mg + Placebo|Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
290957|NCT00124072|B3|Baseline|Simvastatin 20 mg + Placebo|Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
290960|NCT00124072|P4|Participant Flow|Simvastatin 80 mg + Placebo|Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
290961|NCT00124072|P3|Participant Flow|Simvastatin 20 mg + Placebo|Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
290962|NCT00124072|P2|Participant Flow|Simvastatin 80 mg + Folic Acid and B12|Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
290963|NCT00124072|P1|Participant Flow|Simvastatin 20 mg + Folic Acid and B12|Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
290964|NCT00124072|O4|Outcome|Placebo|Placebo vitamin B12/folic acid tablet once daily in the following arms: simvastatin 20 mg daily + placebo vitamin B12/folic acid; simvastatin 80 mg daily + placebo vitamin B12/folic acid
290965|NCT00124072|O3|Outcome|Folic Acid 2 mg + Vitamin B12 1 mg Daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active)
290966|NCT00124072|O2|Outcome|Simvastatin 80 mg Daily|Simvastatin 80 mg tablet once daily in the following arms: simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + placebo vitamin B12/folic acid
290967|NCT00124072|O1|Outcome|Simvastatin 20 mg Daily|Simvastatin 20 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 20 mg daily + placebo vitamin B12/folic acid
290968|NCT00124072|E4|Reported Event|Placebo|Placebo vitamin B12/folic acid tablet once daily in the following arms: simvastatin 20 mg daily + placebo vitamin B12/folic acid; simvastatin 80 mg daily + placebo vitamin B12/folic acid
290969|NCT00124072|E3|Reported Event|Folic Acid 2 mg + Vitamin B12 1 mg Daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active)
290970|NCT00124072|E2|Reported Event|Simvastatin 80 mg Daily|Simvastatin 80 mg tablet once daily in the following arms: simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + placebo vitamin B12/folic acid
290971|NCT00124072|E1|Reported Event|Simvastatin 20 mg Daily|Simvastatin 20 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 20 mg daily + placebo vitamin B12/folic acid
290972|NCT00124176|B3|Baseline|Total|Total of all reporting groups
290973|NCT00124176|B2|Baseline|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
290974|NCT00124176|B1|Baseline|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
290975|NCT00124176|P2|Participant Flow|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
290976|NCT00124176|P1|Participant Flow|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
290977|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
290978|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
290979|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
290980|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
290981|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
290982|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
290983|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
290984|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
290985|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
290986|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
290987|NCT00124176|E2|Reported Event|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
290988|NCT00124176|E1|Reported Event|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
290989|NCT00124579|B1|Baseline|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).
Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
290990|NCT00124579|P1|Participant Flow|Bortezomib With Thalidomide and Dexamethasone Induction|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).
Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
290991|NCT00124579|O1|Outcome|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).
Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
290992|NCT00124579|O1|Outcome|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).
Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
290993|NCT00124579|O1|Outcome|Bortezomib + Thal/Dex|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).
Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
292655|NCT00132314|E1|Reported Event|Injectable Risperidone|long-acting injectable risperidone
290994|NCT00124579|E1|Reported Event|Bortezomib + Thal/Dex|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).
Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
290995|NCT00124618|B1|Baseline|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
290996|NCT00124618|P1|Participant Flow|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
290997|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
290998|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
290999|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
291000|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
291001|NCT00124618|E1|Reported Event|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
291002|NCT00124657|B4|Baseline|Total|Total of all reporting groups
291003|NCT00124657|B3|Baseline|Phase II Only|39 participants were enrolled on the Phase II portion of the trial only.
291004|NCT00124657|B2|Baseline|Phase I and Phase II|5 patients participated in both the Phase I portion and the Phase II portion of the study.
291005|NCT00124657|B1|Baseline|Phase I Only|18 participants were enrolled on the Phase I portion of the trial only.
291006|NCT00124657|P3|Participant Flow|Phase II Only|39 participants were enrolled on the Phase II portion of the trial only.
291007|NCT00124657|P2|Participant Flow|Phase I and Phase II|5 patients participated in both the Phase I portion and the Phase II portion of the study.
291008|NCT00124657|P1|Participant Flow|Phase I Only|18 participants were enrolled on the Phase I portion of the trial only.
291009|NCT00124657|O2|Outcome|Grade 4 Toxicity|Grade 4 toxicity per CTCAE 3.0.
291010|NCT00124657|O1|Outcome|Grade 3 Toxicity|Grade 3 toxicity per CTCAE 3.0.
291011|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.
Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
291012|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) are not eligible for this study. Patients with spinal cord tumors will be eligible for the Phase I and Phase II component of this study, but they will not be taken into consideration to estimate PFS in the Phase II component of this trial because of their notoriously worse prognosis. Patients receive erlotinib hydrochloride.
Erlotinib hydrochloride: This study had 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib was given at the MTD during and after RT for 2 years."
291013|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.
Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
291014|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.
Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
291015|NCT00124657|O4|Outcome|Phase II GBM|Participants with a diagnosis of intracranial glioblastoma multiforme (GBM) treated with a combination of maximum safe surgical resection, local RT, and erlotinib.
291016|NCT00124657|O3|Outcome|Phase II AA|Participants with a diagnosis of intracranial anaplastic astrocytoma (AA) treated with a combination of maximum safe surgical resection, local RT, and erlotinib.
291017|NCT00124657|O2|Outcome|Phase I GBM|All participants with a diagnosis of glioblastoma multiforme (GBM) and treated on Phase I.
291018|NCT00124657|O1|Outcome|Phase I AA|All participants with a diagnosis of anaplastic astrocytoma (AA) and treated on Phase I.
291019|NCT00124657|O1|Outcome|Phase I|22 participants were analyzed for MLT over 4 dose levels.
291020|NCT00124657|O1|Outcome|Phase I|Phase I participants
291021|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
291022|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
291023|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
291024|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
291025|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
291026|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
291027|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
291028|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
291029|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
291030|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
291031|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
291035|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
291036|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
291037|NCT00124657|E5|Reported Event|Phase II|Phase II participants received 120 mg/m^2.
291038|NCT00124657|E4|Reported Event|160 mg/m^2 (Phase I)|Participants received dose of 160 mg/m^2, range of actual dose was 151.5-167 mg/m^2.
291039|NCT00124657|E3|Reported Event|120 mg/m^2 (Phase I)|Participants received dose of 120 mg/m^2, range of actual dose was 107-128 mg/m^2.
291040|NCT00124657|E2|Reported Event|90 mg/m^2 (Phase I)|Participants received dose of 90 mg/m^2, range of actual dose was 85-87.5 mg/m^2.
291041|NCT00124657|E1|Reported Event|70 mg/m^2 (Phase I)|Participants received dose of 70 mg/m^2, range of actual dose was 68-83 mg/m^2.
291042|NCT00124709|B3|Baseline|Total|Total of all reporting groups
291043|NCT00124709|B2|Baseline|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
291044|NCT00124709|B1|Baseline|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
291045|NCT00124709|P2|Participant Flow|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
291046|NCT00124709|P1|Participant Flow|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
291047|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
291048|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
291049|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
291050|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
291051|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
291052|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
291053|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
291054|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
291055|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
291056|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
291057|NCT00124709|E2|Reported Event|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
291058|NCT00124709|E1|Reported Event|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
291059|NCT00124735|B11|Baseline|Total|Total of all reporting groups
291060|NCT00124735|B10|Baseline|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291061|NCT00124735|B9|Baseline|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291062|NCT00124735|B8|Baseline|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291063|NCT00124735|B7|Baseline|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291064|NCT00124735|B6|Baseline|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291065|NCT00124735|B5|Baseline|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291066|NCT00124735|B4|Baseline|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291067|NCT00124735|B3|Baseline|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291068|NCT00124735|B2|Baseline|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291069|NCT00124735|B1|Baseline|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291070|NCT00124735|P10|Participant Flow|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291071|NCT00124735|P9|Participant Flow|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291072|NCT00124735|P8|Participant Flow|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291073|NCT00124735|P7|Participant Flow|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291074|NCT00124735|P6|Participant Flow|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291075|NCT00124735|P5|Participant Flow|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
292656|NCT00132496|B3|Baseline|Total|Total of all reporting groups
291076|NCT00124735|P4|Participant Flow|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291077|NCT00124735|P3|Participant Flow|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291078|NCT00124735|P2|Participant Flow|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291079|NCT00124735|P1|Participant Flow|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291080|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291081|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291082|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291083|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291084|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291085|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291086|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291087|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291088|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291089|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291090|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291091|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291092|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291093|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291094|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291095|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291096|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291097|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291098|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291099|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291100|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291101|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291102|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291103|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291104|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291105|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291106|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291107|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291108|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291109|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291110|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291111|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291112|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291113|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291114|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
291115|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291116|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291117|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291118|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291119|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
291120|NCT00124735|E2|Reported Event|Rocuronium Continuous Infusion Maintenance|Subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents)
291121|NCT00124735|E1|Reported Event|Rocuronium Bolus Maintenance|Subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents).
291122|NCT00124748|B3|Baseline|Total|Total of all reporting groups
291123|NCT00124748|B2|Baseline|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291124|NCT00124748|B1|Baseline|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291125|NCT00124748|P2|Participant Flow|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291126|NCT00124748|P1|Participant Flow|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291127|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291128|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291129|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291130|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291131|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291132|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291133|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291222|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291134|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291135|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291136|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291137|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291138|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291139|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291140|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291141|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291142|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291143|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291144|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291145|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291146|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291147|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291148|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291149|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291150|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291151|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291152|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291153|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291154|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291155|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291156|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291223|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291157|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291158|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291159|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291160|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291161|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291162|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291163|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291164|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291165|NCT00124748|E2|Reported Event|Imatinib 800mg|Patients randomized to receive 800 mg imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
291166|NCT00124748|E1|Reported Event|Imatinib 400mg|Oral dose of 400mg imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
291167|NCT00124943|B5|Baseline|Total|Total of all reporting groups
291168|NCT00124943|B4|Baseline|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291169|NCT00124943|B3|Baseline|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291170|NCT00124943|B2|Baseline|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291171|NCT00124943|B1|Baseline|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
291172|NCT00124943|P4|Participant Flow|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291173|NCT00124943|P3|Participant Flow|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291174|NCT00124943|P2|Participant Flow|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291175|NCT00124943|P1|Participant Flow|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
291176|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291177|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291178|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291179|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
291224|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291180|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291181|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291182|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291183|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
291184|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291185|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291186|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291187|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
291188|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291189|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291190|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291191|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
291192|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291193|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291194|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291195|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
291196|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291197|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291198|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291199|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
291200|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291201|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291344|NCT00125138|E4|Reported Event|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
291202|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291203|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
291204|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291205|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291206|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291207|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
291208|NCT00124943|E4|Reported Event|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291209|NCT00124943|E3|Reported Event|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291210|NCT00124943|E2|Reported Event|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
291211|NCT00124943|E1|Reported Event|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
291212|NCT00124982|B3|Baseline|Total|Total of all reporting groups
291213|NCT00124982|B2|Baseline|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291214|NCT00124982|B1|Baseline|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291215|NCT00124982|P3|Participant Flow|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291216|NCT00124982|P2|Participant Flow|ST-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291217|NCT00124982|P1|Participant Flow|Short Term (ST) Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291218|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291219|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291220|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291221|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291345|NCT00125138|E3|Reported Event|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
291225|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291226|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291227|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291228|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291229|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291230|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291231|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291232|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291233|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291234|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291235|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291236|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291237|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291238|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291239|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291240|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291241|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291242|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291243|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291244|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291245|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291246|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291247|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291248|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291249|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291250|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291251|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291252|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291253|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291254|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291255|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291256|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291257|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291258|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291259|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291260|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
291261|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291262|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291263|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291264|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291265|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291266|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291267|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291268|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291269|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291270|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291271|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291272|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291346|NCT00125138|E2|Reported Event|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
291273|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291274|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291275|NCT00124982|O1|Outcome|All Treated Participants|Open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291276|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291277|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291278|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291279|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291280|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291281|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291282|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291283|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291284|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291285|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291286|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291287|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291347|NCT00125138|E1|Reported Event|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
291288|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291289|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291290|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291291|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
291292|NCT00124982|E2|Reported Event|Abatacept (ST)|
291293|NCT00124982|E1|Reported Event|Abatacept (LT)|
291294|NCT00125034|B3|Baseline|Total|Total of all reporting groups
291295|NCT00125034|B2|Baseline|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291296|NCT00125034|B1|Baseline|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291297|NCT00125034|P2|Participant Flow|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291298|NCT00125034|P1|Participant Flow|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291299|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291300|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291301|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291302|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291303|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291348|NCT00125164|B5|Baseline|Total|Total of all reporting groups
291349|NCT00125164|B4|Baseline|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291304|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291305|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291306|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291307|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291308|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291309|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291310|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291311|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291312|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291313|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291314|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291315|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291316|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291317|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291318|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291319|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291320|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291321|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291322|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291323|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291324|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291325|NCT00125034|E2|Reported Event|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291326|NCT00125034|E1|Reported Event|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
291327|NCT00125138|B5|Baseline|Total|Total of all reporting groups
291328|NCT00125138|B4|Baseline|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
291329|NCT00125138|B3|Baseline|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
291330|NCT00125138|B2|Baseline|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
291331|NCT00125138|B1|Baseline|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
291332|NCT00125138|P4|Participant Flow|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
291333|NCT00125138|P3|Participant Flow|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
291334|NCT00125138|P2|Participant Flow|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
291335|NCT00125138|P1|Participant Flow|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
291336|NCT00125138|O4|Outcome|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
291337|NCT00125138|O3|Outcome|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
291338|NCT00125138|O2|Outcome|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
291339|NCT00125138|O1|Outcome|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
291340|NCT00125138|O4|Outcome|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
291341|NCT00125138|O3|Outcome|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
291342|NCT00125138|O2|Outcome|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
291343|NCT00125138|O1|Outcome|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
291351|NCT00125164|B2|Baseline|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291352|NCT00125164|B1|Baseline|Untreated|Observational Group
291353|NCT00125164|P4|Participant Flow|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291354|NCT00125164|P3|Participant Flow|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291355|NCT00125164|P2|Participant Flow|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291356|NCT00125164|P1|Participant Flow|Untreated|Observational Group
291357|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291358|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291359|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291360|NCT00125164|O1|Outcome|Untreated|Observational Group
291361|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291362|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291363|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291364|NCT00125164|O1|Outcome|Untreated|Observational Group
291365|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291366|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291367|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291368|NCT00125164|O1|Outcome|Untreated|Observational Group
291369|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291370|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291371|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291372|NCT00125164|O1|Outcome|Untreated|Observational Group
291373|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291374|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291375|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291376|NCT00125164|O1|Outcome|Untreated|Observational Group
291377|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291378|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291379|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291380|NCT00125164|O1|Outcome|Untreated|Observational Group
291381|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291382|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291383|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291384|NCT00125164|O1|Outcome|Untreated|Observational Group
291385|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291386|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291387|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291388|NCT00125164|O1|Outcome|Untreated|Observational Group
291389|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291390|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291391|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291395|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291396|NCT00125164|O1|Outcome|Untreated|Observational Group
291397|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291398|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291399|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291400|NCT00125164|O1|Outcome|Untreated|Observational Group
291401|NCT00125164|E4|Reported Event|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
291402|NCT00125164|E3|Reported Event|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
291403|NCT00125164|E2|Reported Event|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
291404|NCT00125164|E1|Reported Event|Untreated|Observational Group
291405|NCT00125190|B1|Baseline|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291406|NCT00125190|P1|Participant Flow|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291407|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291408|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291409|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291410|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291411|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291412|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291413|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291414|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291415|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291416|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291417|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291418|NCT00125190|E1|Reported Event|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
291419|NCT00125242|B3|Baseline|Total|Total of all reporting groups
291420|NCT00125242|B2|Baseline|Non Treatment Stimuli Development Participants|Participants for stimuli development provided normative data for stimuli development. e.g., Treatment items were grouped according to typicality of category membership (apple - typical fruit; coconut - atypical fruit). These participants provided the reponses that served as the basis for classifying/organizing stimuli. Because data from this group were used only for the purposes of stimuli development, no findings are reported for this group. See Cameron, R.M., Wambaugh, J.L., & Mauszycki, S. (2008). Effects of age, gender and education on semantic fluency for living and artifact categories. Aphasiology, 22(7/8), 790-801, doi: 10.1080/02687030701818018 for related findings.
291467|NCT00125593|P2|Participant Flow|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
291521|NCT00125658|O2|Outcome|Order B|Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
291421|NCT00125242|B1|Baseline|SFA Treatment Participants|Semantic Feature Analysis (SFA) is a word-retrieval treatment for aphasia. SFA entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, personal associations, associated actions). For some participants, treatment items were grouped by typicality of category membership (e.g, robin-typical bird and penguin-atypical bird). Training of atypical items may stimulate a broader semantic activation of the category and thus, may promote greater generalization. Treatment was applied sequentially to sets of items in single-subject, multiple baseline designs. Thus, replication of treatment effects could be evaluated within and across participants. Treatment was administered by SLPs three times per week until prescribed accuracy levels were met during probes or a maximum number of treatment sessions was completed.
291422|NCT00125242|P2|Participant Flow|SFA Treatment Participants|Stroke survivors who received experimental therapy
291423|NCT00125242|P1|Participant Flow|Non Treatment Stimuli Development Participants|Non-brain-injured participants who were enrolled for the purpose of stimuli development
291424|NCT00125242|O1|Outcome|SFA Treatment Participants|Stroke survivors received Semantic Feature Analysis for the treatment of word-retrieval deficits. Each SFA treatment participant received word-retrieval therapy applied sequentially to experimental lists of items. Effect sizes were calculated for each participant for each list. An average effect size was calculated for each participant and an overall average was determined for all participants as a group.
291425|NCT00125242|E2|Reported Event|NonTreatment Stimuli Development Participants|Non-brain-injured participants who were utilized to develop treatment stimuli.
291426|NCT00125242|E1|Reported Event|SFA Treatment Participants|"Stroke-survivors who received Semantic Feature Analysis therapy for aphasic word-retrieval deficits
Semantic Feature Training: The treatment is designed to stimulate the semantic feature network so that it may serve as not only a mechanism for improving disrupted lexical semantic processing, but also as a compensatory strategy during word retrieval failures."
291427|NCT00125268|B3|Baseline|Total|Total of all reporting groups
291428|NCT00125268|B2|Baseline|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
291429|NCT00125268|B1|Baseline|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
291430|NCT00125268|P2|Participant Flow|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
291431|NCT00125268|P1|Participant Flow|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
291432|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
291433|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
291434|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
291435|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
291436|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
291437|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
291438|NCT00125268|E2|Reported Event|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
291439|NCT00125268|E1|Reported Event|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
291440|NCT00125515|B4|Baseline|Total|Total of all reporting groups
291441|NCT00125515|B3|Baseline|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
291442|NCT00125515|B2|Baseline|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
291443|NCT00125515|B1|Baseline|Placebo|Placebo plus oral naltrexone
291444|NCT00125515|P3|Participant Flow|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
291445|NCT00125515|P2|Participant Flow|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
291446|NCT00125515|P1|Participant Flow|Placebo|Placebo plus oral naltrexone
291447|NCT00125515|O3|Outcome|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
291448|NCT00125515|O2|Outcome|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
291449|NCT00125515|O1|Outcome|Placebo|Placebo plus oral naltrexone
291450|NCT00125515|E3|Reported Event|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
291451|NCT00125515|E2|Reported Event|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
291452|NCT00125515|E1|Reported Event|Placebo|Placebo plus oral naltrexone
291453|NCT00125528|B3|Baseline|Total|Total of all reporting groups
291454|NCT00125528|B2|Baseline|Placebo|placebo: placebo bid
291455|NCT00125528|B1|Baseline|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
291456|NCT00125528|P2|Participant Flow|Placebo|placebo: placebo bid
291457|NCT00125528|P1|Participant Flow|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
291458|NCT00125528|O2|Outcome|Placebo|placebo: placebo bid
291459|NCT00125528|O1|Outcome|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
291460|NCT00125528|O2|Outcome|Placebo|placebo: placebo bid
291461|NCT00125528|O1|Outcome|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
291462|NCT00125528|E2|Reported Event|Placebo|placebo: placebo bid
291463|NCT00125528|E1|Reported Event|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
291464|NCT00125593|B3|Baseline|Total|Total of all reporting groups
291465|NCT00125593|B2|Baseline|Placebo|Once daily tablet
291466|NCT00125593|B1|Baseline|Simvastatin Plus Ezetimibe|Once daily tablet
291468|NCT00125593|P1|Participant Flow|Simvastatin 20mg Plus Ezetimibe 10mg|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
291469|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
291470|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
291471|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
291472|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
291473|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
291474|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
291475|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
291476|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
291477|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
291478|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
291479|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
291480|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
291481|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
291482|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
291483|NCT00125593|E2|Reported Event|Placebo|Once daily tablet
291484|NCT00125593|E1|Reported Event|Simvastatin Plus Ezetimibe|Once daily tablet
291485|NCT00125619|B3|Baseline|Total|Total of all reporting groups
291486|NCT00125619|B2|Baseline|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
291487|NCT00125619|B1|Baseline|Arm 2: Robot-assisted|"Rehabilitation for Post-stroke Hemiparesis
Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
291488|NCT00125619|P2|Participant Flow|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
291489|NCT00125619|P1|Participant Flow|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis
Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
291490|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
291552|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
291491|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis
Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
291492|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
291493|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis
Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
291494|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
291495|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis
Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
291496|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
291497|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis
Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
291498|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
291499|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis
Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
291500|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
291501|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis
Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
291502|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
291503|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation for Post-stroke Hemiparesis
Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
291504|NCT00125619|E2|Reported Event|Arm 1|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
291505|NCT00125619|E1|Reported Event|ARM2|"Rehabilitation got Post-stroke Hemiparesis
Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
291506|NCT00125658|B3|Baseline|Total|Total of all reporting groups
291507|NCT00125658|B2|Baseline|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
Single, unilateral stroke, >6 <26 months post-event."
291508|NCT00125658|B1|Baseline|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
Single, unilateral stroke, >6 <26 months post-event."
291509|NCT00125658|P2|Participant Flow|Order B (Power Prior to FTP)|Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
291510|NCT00125658|P1|Participant Flow|Order A (FTP Prior to Power)|Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
291511|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
Single, unilateral stroke, >6 <26 months post-event."
291512|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
Single, unilateral stroke, >6 <26 months post-event."
291513|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
Single, unilateral stroke, >6 <26 months post-event."
291514|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
Single, unilateral stroke, >6 <26 months post-event."
291515|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
Single, unilateral stroke, >6 <26 months post-event."
291516|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
Single, unilateral stroke, >6 <26 months post-event."
291517|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
Single, unilateral stroke, >6 <26 months post-event."
291518|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
Single, unilateral stroke, >6 <26 months post-event."
291519|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
Single, unilateral stroke, >6 <26 months post-event."
291520|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
Single, unilateral stroke, >6 <26 months post-event."
292072|NCT00129545|E2|Reported Event|WATCHMAN|Randomized to receive implantation of the WATCHMAN LAA closure Device
291522|NCT00125658|O1|Outcome|Order A|Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
291523|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
Single, unilateral stroke, >6 <26 months post-event."
291524|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
Single, unilateral stroke, >6 <26 months post-event."
291525|NCT00125658|E2|Reported Event|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
Single, unilateral stroke, >6 <26 months post-event."
291526|NCT00125658|E1|Reported Event|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
Single, unilateral stroke, >6 <26 months post-event."
291527|NCT00125931|B1|Baseline|Open Label|Open label treatment with pentazocine
291528|NCT00125931|P1|Participant Flow|Treatment Group|Open label group with pentazocine treatment.
291529|NCT00125931|O1|Outcome|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
291530|NCT00125931|O1|Outcome|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
291531|NCT00125931|E1|Reported Event|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
291532|NCT00125957|B3|Baseline|Total|Total of all reporting groups
291533|NCT00125957|B2|Baseline|Placebo-Wellbutrin|Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to Wellbutrin 100 mg twice daily (BID). At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
291534|NCT00125957|B1|Baseline|Wellbutrin-Placebo|Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg twice daily (BID) of Wellbutrin) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
291535|NCT00125957|P2|Participant Flow|Placebo First, Then Wellbutrin|Subjects randomly assigned to the Placebo first, then Wellbutrin group will receive placebo until Week 4 when they will cross-over to active drug. At Week 4, subjects will be assigned 100mg Wellbutrin BID. At Week 5, Subjects will be increased to 150mg Wellbutrin BID unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of Wellbutrin qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on bupropion 100mg BID. Subject will continue on the assigned dosage until Week 8 of study.
291536|NCT00125957|P1|Participant Flow|Wellbutrin First, Then Placebo|Subjects randomly assigned to the Wellbutrin first, then Placebo group will receive 100mg BID of Wellbutrin at the first visit following intake (Week 0).Subjects will be increased to 150mg Wellbutrin BID at Week 1 unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of bupropion qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on Wellbutrin 100mg BID. At Week 4, subjects will cross-over to placebo and will continue to take placebo until Week 8.
291537|NCT00125957|O2|Outcome|Placebo First, Then Wellbutrin|Subjects randomly assigned to Treatment B will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
291538|NCT00125957|O1|Outcome|Wellbutrin First, Then Placebo|Subjects randomly assigned to Treatment A will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
291539|NCT00125957|O2|Outcome|Placebo First, Then Wellbutrin|Subjects randomly assigned to Treatment B will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
291540|NCT00125957|O1|Outcome|Wellbutrin First, Then Placebo|Subjects randomly assigned to Treatment A will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
291541|NCT00125957|E2|Reported Event|Placebo-Bupropion|Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to bupropion 100 mg BID. At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
291542|NCT00125957|E1|Reported Event|Bupropion-Placebo|Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg BID bupropion) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
291543|NCT00126113|B3|Baseline|Total|Total of all reporting groups
291544|NCT00126113|B2|Baseline|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
291545|NCT00126113|B1|Baseline|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
291546|NCT00126113|P2|Participant Flow|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
291547|NCT00126113|P1|Participant Flow|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
291548|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
291549|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
291550|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
291551|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
292657|NCT00132496|B2|Baseline|Rabeprazole 20 mg|once daily for 8 weeks
291553|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
291554|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
291555|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
291556|NCT00126113|E2|Reported Event|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
291557|NCT00126113|E1|Reported Event|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
291558|NCT00126126|B3|Baseline|Total|Total of all reporting groups
291559|NCT00126126|B2|Baseline|Wait List Control Group|Those subjects who were randomized to the wait-list control group.
291560|NCT00126126|B1|Baseline|Intervention|Those subjects who were randomized to receive the Evidence Based Amputee Rehabilitation (EBAR) Program
291561|NCT00126126|P2|Participant Flow|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
291562|NCT00126126|P1|Participant Flow|Intervention|"Evidence Based Amputee Rehabilitation Program
Exercise: Evidence Based Amputee Rehabilitation Program"
291563|NCT00126126|O2|Outcome|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
291564|NCT00126126|O1|Outcome|Intervention|"Evidence Based Amputee Rehabilitation Program
Exercise: Evidence Based Amputee Rehabilitation Program"
291565|NCT00126126|O2|Outcome|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
291566|NCT00126126|O1|Outcome|Intervention|"Evidence Based Amputee Rehabilitation Program
Exercise: Evidence Based Amputee Rehabilitation Program"
291567|NCT00126126|E2|Reported Event|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
291568|NCT00126126|E1|Reported Event|Intervention|"Evidence Based Amputee Rehabilitation Program
Exercise: Evidence Based Amputee Rehabilitation Program"
291569|NCT00126191|B3|Baseline|Total|Total of all reporting groups
291570|NCT00126191|B2|Baseline|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
291571|NCT00126191|B1|Baseline|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
291572|NCT00126191|P2|Participant Flow|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
291573|NCT00126191|P1|Participant Flow|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
291574|NCT00126191|O2|Outcome|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
291575|NCT00126191|O1|Outcome|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
291576|NCT00126191|O2|Outcome|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
291577|NCT00126191|O1|Outcome|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
291578|NCT00126191|E2|Reported Event|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
291579|NCT00126191|E1|Reported Event|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
291580|NCT00126425|B3|Baseline|Total|Total of all reporting groups
291581|NCT00126425|B2|Baseline|AdreView--Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at no risk of heart failure.
291582|NCT00126425|B1|Baseline|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at a high risk of heart failure.
291583|NCT00126425|P2|Participant Flow|AdreView--Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
291584|NCT00126425|P1|Participant Flow|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
291585|NCT00126425|O2|Outcome|AdreView-Heart Failure Group With Low H/M Ratio|Participants in HF group who had low H/M ratio (less than 1.6)
291586|NCT00126425|O1|Outcome|AdreView-Heart Failure Group With High H/M Ratio|Participants in HF group who had high H/M ratio (more than or equal to 1.6)
291587|NCT00126425|E2|Reported Event|AdreView --Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
291588|NCT00126425|E1|Reported Event|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
291589|NCT00126438|B3|Baseline|Total|Total of all reporting groups
291590|NCT00126438|B2|Baseline|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
291591|NCT00126438|B1|Baseline|AdreView - Heart Failure|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
291592|NCT00126438|P2|Participant Flow|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
291593|NCT00126438|P1|Participant Flow|AdreView - Heart Failure Group|AdreView (123I-mIBG [meta-iodobenzylguanidine]): 10 milliCurie (mCi) as a single intravenous dose.
291594|NCT00126438|O2|Outcome|AdreView-Heart Failure Group With Low H/M Ratio|Participants in HF group who had low H/M ratio (less than 1.6).
291595|NCT00126438|O1|Outcome|AdreView-Heart Failure Group With High H/M Ratio|Participants in HF group who had high H/M ratio (more than or equal to 1.6).
291596|NCT00126438|E2|Reported Event|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
291597|NCT00126438|E1|Reported Event|AdreView - Heart Failure|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
291616|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
292658|NCT00132496|B1|Baseline|Rabeprazole 10 mg|once daily for 8 weeks
291598|NCT00126490|B1|Baseline|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
291599|NCT00126490|P1|Participant Flow|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
291600|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
291601|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
291602|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
291603|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
291604|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
291605|NCT00126490|E1|Reported Event|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
291606|NCT00126503|B3|Baseline|Total|Total of all reporting groups
291607|NCT00126503|B2|Baseline|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
291608|NCT00126503|B1|Baseline|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
291609|NCT00126503|P2|Participant Flow|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
291610|NCT00126503|P1|Participant Flow|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
291611|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1. No Phase II patients were in the Phase I cohort.
291612|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. No Phase I patients moved to the Phase II cohort.
291613|NCT00126503|O1|Outcome|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
291614|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
291615|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability.
291617|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability.
291618|NCT00126503|O1|Outcome|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3-day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
291619|NCT00126503|E2|Reported Event|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
291620|NCT00126503|E1|Reported Event|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
291621|NCT00126555|B1|Baseline|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
291622|NCT00126555|P1|Participant Flow|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
291623|NCT00126555|O4|Outcome|Maintenance Phase|Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
291624|NCT00126555|O3|Outcome|Radiation With Gefitinib|Participants received Radiation with Gefitinib therapy following evaluation for clinical response and resectability at Induction (with or without dose doubling): Resectable strata who achieved at least stable disease received surgery followed by radiation treatment and 12 additional months of Gefitinib post radiation; and the Unresectable strata who achieved at least stable disease received concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated).
291625|NCT00126555|O2|Outcome|Induction Phase With Dose Escalation|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib starting dose 250 mg/day with doubling to 500 mg/day for no response Day 15.
291626|NCT00126555|O1|Outcome|Induction Phase|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib Induction Phase dose 250 mg/day with no doubling for no response at Day 15.
291627|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
291628|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|"Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
291629|NCT00126555|O4|Outcome|Maintenance|Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
291630|NCT00126555|O3|Outcome|Radiation With Gefitinib|Participants received Radiation with Gefitinib therapy following evaluation for clinical response and resectability at Induction (with or without dose doubling): Resectable strata who achieved at least stable disease received surgery followed by radiation treatment and 12 additional months of Gefitinib post radiation; and the Unresectable strata who achieved at least stable disease received concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated).
291631|NCT00126555|O2|Outcome|Induction With Dose Escalation|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib starting dose 250 mg/day with doubling to 500 mg/day for no response Day 15.
291632|NCT00126555|O1|Outcome|Induction Phase|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib Induction Phase dose 250 mg/day with no doubling for no response at Day 15.
291633|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|"Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
328472|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
291634|NCT00126555|E1|Reported Event|Gefitinib, Radiotherapy, Surgery|"Resectable Strata: Induction Gefitinib (60 days), Surgery followed 3-6 weeks later by daily Radiotherapy 5 days a week for approximately 6-7 weeks then after 4 weeks restart Maintenance Gefitinib for up to additional 12 months post radiation.
Unresectable Strata: Concomitant Radiation/Gefitinib and post-radiation (or post-surgery if surgery is indicated) Gefitinib. Daily Radiotherapy 5 days a week for approximately 6-7 weeks concurrent with Maintenance Gefitinib dose daily up to 12 months.
Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
291635|NCT00126568|B1|Baseline|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
291636|NCT00126568|P1|Participant Flow|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
291637|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
291638|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
291639|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
291640|NCT00126568|E1|Reported Event|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
291641|NCT00126581|B3|Baseline|Total|Total of all reporting groups
291642|NCT00126581|B2|Baseline|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
291643|NCT00126581|B1|Baseline|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
291644|NCT00126581|P2|Participant Flow|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
291645|NCT00126581|P1|Participant Flow|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
291646|NCT00126581|O2|Outcome|Wild Type|
291647|NCT00126581|O1|Outcome|Mutant|
291648|NCT00126581|O2|Outcome|Wild Type|
291649|NCT00126581|O1|Outcome|Mutant|
291650|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
291651|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
291652|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
291653|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
291654|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
291655|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
291656|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
291657|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
291658|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
291659|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
291660|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
291698|NCT00126737|P4|Participant Flow|Usual Care|Usual care and non-specific health information (C). No intervention.
291661|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
291662|NCT00126581|E2|Reported Event|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
291663|NCT00126581|E1|Reported Event|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
291664|NCT00126594|B3|Baseline|Total|Total of all reporting groups
291665|NCT00126594|B2|Baseline|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
291666|NCT00126594|B1|Baseline|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
291667|NCT00126594|P2|Participant Flow|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
291668|NCT00126594|P1|Participant Flow|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
291669|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
291670|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
291671|NCT00126594|O1|Outcome|Sorafenib Tosylate or Sorafenib Plus Interferon|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28 and Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
291672|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
291673|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
291674|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
291675|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
291676|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
291677|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
291678|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
291679|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
291680|NCT00126594|E2|Reported Event|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
291681|NCT00126594|E1|Reported Event|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
291682|NCT00126659|B4|Baseline|Total|Total of all reporting groups
291683|NCT00126659|B3|Baseline|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
291684|NCT00126659|B2|Baseline|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
291685|NCT00126659|B1|Baseline|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
291686|NCT00126659|P3|Participant Flow|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
291687|NCT00126659|P2|Participant Flow|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
291688|NCT00126659|P1|Participant Flow|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
291689|NCT00126659|O3|Outcome|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
291690|NCT00126659|O2|Outcome|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
291691|NCT00126659|O1|Outcome|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
291692|NCT00126659|E1|Reported Event|Sorafenib + Cytoreductive Nephrectomy|All participants received Sorafenib 400 mg orally mouth twice a day for a total of 10 weeks over the course of the study and had surgical procedure Cytoreductive Nephrectomy before treatment with Sorafenib or in between courses of Sorafenib
291693|NCT00126737|B5|Baseline|Total|Total of all reporting groups
291694|NCT00126737|B4|Baseline|Usual Care|Usual care and non-specific health information (C). No intervention.
291695|NCT00126737|B3|Baseline|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).
Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291696|NCT00126737|B2|Baseline|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
291697|NCT00126737|B1|Baseline|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise Program (Ex+WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
292659|NCT00132496|P2|Participant Flow|Rabeprazole 20 mg|once daily for 8 weeks
291699|NCT00126737|P3|Participant Flow|Home-based Exercise Program|"Group assigned to a home-based exercise program (Ex).
Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291700|NCT00126737|P2|Participant Flow|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
291701|NCT00126737|P1|Participant Flow|Weight Control Nutritional and Home-based Exercise Program|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises"
291702|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
291703|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).
Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291704|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
291705|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291706|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
291707|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).
Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291708|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
291709|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291710|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
291711|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).
Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291712|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
291713|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise pr|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291714|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
291715|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).
Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291716|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
291717|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291718|NCT00126737|O4|Outcome|Usual Care|Usual care and non-specific health information (C). No intervention.
291719|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a home-based exercise program (Ex).
Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291720|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
291721|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291722|NCT00126737|E4|Reported Event|Usual Care|Usual Care and non-specific health information (C). No intervention.
291723|NCT00126737|E3|Reported Event|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).
Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291724|NCT00126737|E2|Reported Event|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
291725|NCT00126737|E1|Reported Event|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
291726|NCT00126750|B3|Baseline|Total|Total of all reporting groups
291727|NCT00126750|B2|Baseline|Control Arm/Group|Providers from eligible clinics that were allocated to the control arm.
291728|NCT00126750|B1|Baseline|Intervention Arm/Group|Providers from eligible clinics that were allocated to the intervention arm.
291729|NCT00126750|P2|Participant Flow|Control Group|Providers in control clinics were sent a link to an existing VA Web site that contained links to a wide range of clinical guidelines for various medical conditions.
291730|NCT00126750|P1|Participant Flow|Intervention Group|The intervention included a multicomponent Web site and pushed e-mail cues with educational content.
291731|NCT00126750|O2|Outcome|Control|Control Providers received a link to VA practice guidelines.
291732|NCT00126750|O1|Outcome|Intervention|Intervention Providers received an interactive, educational website and motivational reminders.
291733|NCT00126750|E2|Reported Event|Control Group|Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.
291734|NCT00126750|E1|Reported Event|Intervention Group|Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.
291735|NCT00126776|B3|Baseline|Total|Total of all reporting groups
291736|NCT00126776|B2|Baseline|Usual Care|usual care
291737|NCT00126776|B1|Baseline|Disease Management for COPD|disease management for COPD
291738|NCT00126776|P2|Participant Flow|Usual Care|usual care
291739|NCT00126776|P1|Participant Flow|Disease Management for COPD|disease management for COPD
291740|NCT00126776|O2|Outcome|Usual Care|usual care
291741|NCT00126776|O1|Outcome|Disease Management for COPD|disease management for COPD
291742|NCT00127036|B3|Baseline|Total|Total of all reporting groups
291743|NCT00127036|B2|Baseline|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291744|NCT00127036|B1|Baseline|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291745|NCT00127036|P2|Participant Flow|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291746|NCT00127036|P1|Participant Flow|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291747|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291748|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291749|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291750|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291751|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291752|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291753|NCT00127036|E2|Reported Event|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291754|NCT00127036|E1|Reported Event|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
291755|NCT00127101|B7|Baseline|Total|Total of all reporting groups
291756|NCT00127101|B6|Baseline|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
291757|NCT00127101|B5|Baseline|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
291758|NCT00127101|B4|Baseline|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
291759|NCT00127101|B3|Baseline|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
291760|NCT00127101|B2|Baseline|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
291761|NCT00127101|B1|Baseline|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
291762|NCT00127101|P6|Participant Flow|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
291763|NCT00127101|P5|Participant Flow|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
291764|NCT00127101|P4|Participant Flow|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
291765|NCT00127101|P3|Participant Flow|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
291766|NCT00127101|P2|Participant Flow|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
291767|NCT00127101|P1|Participant Flow|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
291768|NCT00127101|O6|Outcome|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
291769|NCT00127101|O5|Outcome|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
291770|NCT00127101|O4|Outcome|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
291771|NCT00127101|O3|Outcome|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
291772|NCT00127101|O2|Outcome|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
291773|NCT00127101|O1|Outcome|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
291774|NCT00127101|O6|Outcome|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
291775|NCT00127101|O5|Outcome|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
291776|NCT00127101|O4|Outcome|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
291777|NCT00127101|O3|Outcome|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
291778|NCT00127101|O2|Outcome|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
291779|NCT00127101|O1|Outcome|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
291780|NCT00127101|E6|Reported Event|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
291781|NCT00127101|E5|Reported Event|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
291782|NCT00127101|E4|Reported Event|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
291783|NCT00127101|E3|Reported Event|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
291784|NCT00127101|E2|Reported Event|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
291785|NCT00127101|E1|Reported Event|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
291786|NCT00121134|B5|Baseline|Total|Total of all reporting groups
291787|NCT00121134|B4|Baseline|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
291788|NCT00121134|B3|Baseline|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
291789|NCT00121134|B2|Baseline|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
291790|NCT00121134|B1|Baseline|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
291791|NCT00121134|P4|Participant Flow|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
291792|NCT00121134|P3|Participant Flow|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
291793|NCT00121134|P2|Participant Flow|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
291794|NCT00121134|P1|Participant Flow|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
291795|NCT00121134|O4|Outcome|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
291796|NCT00121134|O3|Outcome|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
291797|NCT00121134|O2|Outcome|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
291798|NCT00121134|O1|Outcome|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
291799|NCT00121134|E4|Reported Event|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
291800|NCT00121134|E3|Reported Event|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
291801|NCT00121134|E2|Reported Event|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
291802|NCT00121134|E1|Reported Event|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
291803|NCT00121186|B1|Baseline|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
291846|NCT00127192|B4|Baseline|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
292660|NCT00132496|P1|Participant Flow|Rabeprazole 10 mg|once daily for 8 weeks
291804|NCT00121186|P1|Participant Flow|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
291805|NCT00121186|O1|Outcome|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
291806|NCT00121186|O1|Outcome|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
291807|NCT00121186|E1|Reported Event|Nonmyeloablative Allogeneic Stem Cell Transplant|
291808|NCT00121199|B1|Baseline|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
291809|NCT00121199|P1|Participant Flow|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
291810|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
291811|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
291812|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
291813|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
291814|NCT00121199|E1|Reported Event|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
291815|NCT00121225|B1|Baseline|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.
vorinostat"
291816|NCT00121225|P1|Participant Flow|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.
vorinostat"
291817|NCT00121225|O1|Outcome|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.
vorinostat"
291818|NCT00121225|E1|Reported Event|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.
vorinostat"
291819|NCT00121238|B1|Baseline|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
cilengitide : Given IV
Experimental drug treatment : Correlative studies"
291820|NCT00121238|P1|Participant Flow|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
cilengitide : Given IV
Experimental drug treatment : Correlative studies"
291821|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
cilengitide : Given IV
Experimental drug treatment : Correlative studies"
291843|NCT00127166|E1|Reported Event|Montelukast|"Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks.
Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks.
Inhaled Fluticasone 100 mcg twice daily throughout the study."
291844|NCT00127192|B6|Baseline|Total|Total of all reporting groups
291845|NCT00127192|B5|Baseline|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
291822|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
cilengitide : Given IV
Experimental drug treatment : Correlative studies"
291823|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
cilengitide : Given IV
Experimental drug treatment : Correlative studies"
291824|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
cilengitide : Given IV
Experimental drug treatment : Correlative studies"
291825|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
cilengitide : Given IV
Experimental drug treatment : Correlative studies"
291826|NCT00121238|E1|Reported Event|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
cilengitide : Given IV
Experimental drug treatment : Correlative studies"
291827|NCT00127166|B3|Baseline|Total|Total of all reporting groups
291828|NCT00127166|B2|Baseline|Salmeterol / Montelukast|Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
291829|NCT00127166|B1|Baseline|Montelukast / Salmeterol|Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
291830|NCT00127166|P2|Participant Flow|Salmeterol / Montelukast|Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
291831|NCT00127166|P1|Participant Flow|Montelukast / Salmeterol|Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
291832|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
291833|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
291834|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
291835|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
291836|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
291837|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
291838|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
291839|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
291840|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
291841|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
291842|NCT00127166|E2|Reported Event|Salmeterol|"Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks.
Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks.
Inhaled Fluticasone 100 mcg twice daily throughout the study."
291943|NCT00129246|B3|Baseline|Total|Total of all reporting groups
291847|NCT00127192|B3|Baseline|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
291848|NCT00127192|B2|Baseline|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
291849|NCT00127192|B1|Baseline|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
291850|NCT00127192|P5|Participant Flow|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
291851|NCT00127192|P4|Participant Flow|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
291852|NCT00127192|P3|Participant Flow|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
291853|NCT00127192|P2|Participant Flow|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
291854|NCT00127192|P1|Participant Flow|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
291855|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
291856|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
291857|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
291858|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
291859|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
291860|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
291861|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
291862|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
291863|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
291864|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
291865|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
291866|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
291867|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
291868|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
291869|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
291870|NCT00127192|E5|Reported Event|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
291871|NCT00127192|E4|Reported Event|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
291872|NCT00127192|E3|Reported Event|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
291873|NCT00127192|E2|Reported Event|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
291874|NCT00127192|E1|Reported Event|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
291875|NCT00127218|B3|Baseline|Total|Total of all reporting groups
291876|NCT00127218|B2|Baseline|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
291877|NCT00127218|B1|Baseline|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
291878|NCT00127218|P2|Participant Flow|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
291879|NCT00127218|P1|Participant Flow|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
291880|NCT00127218|O2|Outcome|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
291881|NCT00127218|O1|Outcome|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
292073|NCT00129545|E1|Reported Event|Roll-in|Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
291882|NCT00127218|E2|Reported Event|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
291883|NCT00127218|E1|Reported Event|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
291884|NCT00127413|B5|Baseline|Total|Total of all reporting groups
291885|NCT00127413|B4|Baseline|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
291886|NCT00127413|B3|Baseline|Cognitive Behavioral Therapy-Integrated|Integrated treatment for comorbid chronic pain and PTSD
291887|NCT00127413|B2|Baseline|Cognitive Processing Therapy-PTSD|Cognitive processing therapy for PTSD
291888|NCT00127413|B1|Baseline|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
291889|NCT00127413|P4|Participant Flow|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
291890|NCT00127413|P3|Participant Flow|Cognitive Behavioral Therapy - Integrated|Integrated treatment for comorbid chronic pain and PTSD
291891|NCT00127413|P2|Participant Flow|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
291892|NCT00127413|P1|Participant Flow|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
291893|NCT00127413|O4|Outcome|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider
291894|NCT00127413|O3|Outcome|Cognitive Behavioral Therapy - Integrated|Cognitive Behavioral Therapy - Integrated treatment for pain and PTSD
291895|NCT00127413|O2|Outcome|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
291896|NCT00127413|O1|Outcome|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
291897|NCT00127413|E4|Reported Event|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
291898|NCT00127413|E3|Reported Event|Cognitive Behavioral Therapy-Integrated|Integrated treatment for comorbid chronic pain and PTSD
291899|NCT00127413|E2|Reported Event|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
291900|NCT00127413|E1|Reported Event|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
291901|NCT00129220|B4|Baseline|Total|Total of all reporting groups
291902|NCT00129220|B3|Baseline|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291903|NCT00129220|B2|Baseline|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291904|NCT00129220|B1|Baseline|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291905|NCT00129220|P3|Participant Flow|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291906|NCT00129220|P2|Participant Flow|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291907|NCT00129220|P1|Participant Flow|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291908|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291909|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291910|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291911|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291912|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291913|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291914|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291915|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291916|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291917|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291918|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291919|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291920|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291921|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291922|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291923|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291924|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291925|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291926|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291927|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291928|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291929|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291930|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291931|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291932|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day
291933|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day
291934|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291935|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291936|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291937|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291938|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291939|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291940|NCT00129220|E3|Reported Event|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
291941|NCT00129220|E2|Reported Event|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
291942|NCT00129220|E1|Reported Event|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
291944|NCT00129246|B2|Baseline|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291945|NCT00129246|B1|Baseline|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291946|NCT00129246|P2|Participant Flow|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291947|NCT00129246|P1|Participant Flow|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291948|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291949|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291950|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291951|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291952|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291953|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291954|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291955|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
292074|NCT00129623|B3|Baseline|Total|Total of all reporting groups
291956|NCT00129246|E2|Reported Event|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291957|NCT00129246|E1|Reported Event|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
291958|NCT00129259|B3|Baseline|Total|Total of all reporting groups
291959|NCT00129259|B2|Baseline|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
291960|NCT00129259|B1|Baseline|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
291961|NCT00129259|P2|Participant Flow|Diabetes Standard of Care Treatment|"Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
Iron supplementation was initiated status post treatment randomization."
291962|NCT00129259|P1|Participant Flow|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|"Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
Iron supplementation was initiated status post treatment randomization."
291963|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
291964|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
291965|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
291966|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
291967|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
291968|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
291969|NCT00129259|E2|Reported Event|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
291970|NCT00129259|E1|Reported Event|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
291971|NCT00129272|B3|Baseline|Total|Total of all reporting groups
291972|NCT00129272|B2|Baseline|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
291973|NCT00129272|B1|Baseline|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
291974|NCT00129272|P2|Participant Flow|Matching Placebo|"This arm included placebo treatment twice daily for 9 weeks. Drug and placebo were compounded to look identical, masking both drug type and dosage.
All participants (both drug and placebo groups) received a modified version of the brief office intervention program for adolescent smokers, developed by the American Medical Association. Subjects met with a research counselor for 10 consecutive weekly sessions. The initial session (baseline visit) was 60 min. while the remaining sessions were 20-30 min. Each session was individualized to the needs of the adolescent, based on information gathered at the baseline assessment. The brief office intervention materials include checklists and guidelines for each session to assist the counselor in tailoring the session to the needs of the youth. It involved motivational interviewing, incorporating stages of change, peer and parental and other social influences; negative affect and other psychological factors, addiction and self-efficacy."
291975|NCT00129272|P1|Participant Flow|Active Drug (Burpropion-SR)|"In total 172 participants were recruited, and 144 were randomized.
Using a double-blind, randomized, placebo-controlled design, participants were randomized to active drug or placebo using the modified Efron’s biased coin toss method to ensure that the drug/placebo cells are balanced with respect to severe depression, presence of nicotine dependence symptoms and gender.
Participants received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
The participants had weekly visits with the target quitting date set for Day 8. The medication checks lasted about 30-45 minutes. The focus was on elicitation of smoking status, nicotine craving and withdrawal symptoms, depressive symptoms and side effects. Body weight and vital signs were measured as well as expired air for CO and urine cotinine levels. Plasma drug levels were obtained at 5 and 9 weeks of treatment."
291976|NCT00129272|O2|Outcome|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
291977|NCT00129272|O1|Outcome|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
291978|NCT00129272|O2|Outcome|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
291979|NCT00129272|O1|Outcome|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
291980|NCT00129272|E2|Reported Event|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
291981|NCT00129272|E1|Reported Event|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
291982|NCT00129311|B3|Baseline|Total|Total of all reporting groups
291983|NCT00129311|B2|Baseline|Placebo|"Placebo
Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
291984|NCT00129311|B1|Baseline|Selegiline|"Selegiline
Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
292069|NCT00129545|O2|Outcome|Warfarin Control|"Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Warfarin: Subjects receive warfarin"
292661|NCT00132496|O2|Outcome|Rabeprazole 20 mg|once daily for 8 weeks
291985|NCT00129311|P2|Participant Flow|Placebo|"Placebo
Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
291986|NCT00129311|P1|Participant Flow|Selegiline|"Selegiline
Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
291987|NCT00129311|O2|Outcome|Placebo|"Placebo
Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
291988|NCT00129311|O1|Outcome|Selegiline|"Selegiline
Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
291989|NCT00129311|O2|Outcome|Placebo|"Placebo
Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
291990|NCT00129311|O1|Outcome|Selegiline|"Selegiline
Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
291991|NCT00129311|E2|Reported Event|Placebo|"Placebo
Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
291992|NCT00129311|E1|Reported Event|Selegiline|"Selegiline
Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
291993|NCT00129402|B3|Baseline|Total|Total of all reporting groups
291994|NCT00129402|B2|Baseline|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
291995|NCT00129402|B1|Baseline|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
291996|NCT00129402|P7|Participant Flow|Long-term Experience Ezetimbe/Simvastatin|Subjects who received long-term coadministration of ezetimibe with simvastatin once daily
291997|NCT00129402|P6|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 40|Subjects who received simvastatin monotherapy 40 mg once daily
291998|NCT00129402|P5|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 20|Subjects who received simvastatin monotherapy 20 mg once daily
291999|NCT00129402|P4|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 10|Subjects who received simvastatin monotherapy 10 mg once daily
292000|NCT00129402|P3|Participant Flow|Ezetimibe/Simvastatin 10/40|Subjects who received ezetimibe 10 mg plus simvastatin 40 mg once daily
292001|NCT00129402|P2|Participant Flow|Ezetimibe/Simvastatin 10/20|Subjects who received ezetimibe 10 mg with simvastatin 10 mg once daily
292002|NCT00129402|P1|Participant Flow|Ezetimibe/Simvastatin 10/10|Subjects who received ezetimibe 10 mg plus simvastatin 10 mg once daily
292003|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
292004|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
292005|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
292006|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
292007|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
292008|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
292009|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
292010|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
292011|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|pooled subjects who received simvastatin 10 mg monotherapy, simvastatin 20 mg monotherapy, or simvastatin 40 mg monotherapy
292012|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
292013|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
292014|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
292125|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292015|NCT00129402|E3|Reported Event|Long-term Coadministration of Ezetimibe With Simvastatin|"Column 3 provides the combined AE data collected for
all subjects that participated during Period 3. One subject who entered Period 3 did not receive study medication and was not included in the analysis."
292016|NCT00129402|E2|Reported Event|Simvastatin Monotherapy|"Column 2 provides the combined AE data collected for subjects in the simvastatin monotherapy treatment
groups during Period 1 and Period 2."
292017|NCT00129402|E1|Reported Event|Ezetimibe With Simvastatin|Column 1 provides the combined AE data collected for subjects in the ezetimibe with simvastatin treatment groups during Period 1 and Period 2
292018|NCT00129441|B3|Baseline|Total|Total of all reporting groups
292019|NCT00129441|B2|Baseline|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
292020|NCT00129441|B1|Baseline|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
292021|NCT00129441|P2|Participant Flow|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
292022|NCT00129441|P1|Participant Flow|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
292023|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
292024|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
292025|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
292026|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
292027|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
292028|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
292029|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
292030|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
292031|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
292032|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
292033|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
292034|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
292035|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
292036|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
292037|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
292038|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
292039|NCT00129441|E2|Reported Event|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
292040|NCT00129441|E1|Reported Event|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
292041|NCT00129467|B3|Baseline|Total|Total of all reporting groups
292042|NCT00129467|B2|Baseline|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
292070|NCT00129545|O1|Outcome|Implantable Device|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device
WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology"
292071|NCT00129545|E3|Reported Event|WARFARIN|Randomized to receive Warfarin control
292043|NCT00129467|B1|Baseline|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
292044|NCT00129467|P2|Participant Flow|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
292045|NCT00129467|P1|Participant Flow|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
292046|NCT00129467|O2|Outcome|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
292047|NCT00129467|O1|Outcome|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
292048|NCT00129467|E2|Reported Event|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
292049|NCT00129467|E1|Reported Event|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
292050|NCT00129480|B3|Baseline|Total|Total of all reporting groups
292051|NCT00129480|B2|Baseline|Treatment as Usual|Treatment as usual which includes standard pain care, clinician generated referrals for additional consultation and ancillary services
292052|NCT00129480|B1|Baseline|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers
Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
292053|NCT00129480|P2|Participant Flow|Treatment as Usual|Treatment as usual
292054|NCT00129480|P1|Participant Flow|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers
Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
292055|NCT00129480|O2|Outcome|Treatment as Usual|Pain treatment as usual
292056|NCT00129480|O1|Outcome|Assistance With Pain Treatment (Intervention)|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers
Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
292057|NCT00129480|E2|Reported Event|Treatment as Usual|Treatment as usual, which includes standard pain care, clinician-generated referrals for additional consultation and ancillary services
292058|NCT00129480|E1|Reported Event|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers
Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
292059|NCT00129545|B4|Baseline|Total|Total of all reporting groups
292060|NCT00129545|B3|Baseline|Roll-in|Subjects received WATCHMAN Left Atrial Appendage Closure Technology but were not included in the outcome analysis
292061|NCT00129545|B2|Baseline|Warfarin Control|Subjects were treated with current standard of care Oral Anticoagulation Therapy with Warfarin
292062|NCT00129545|B1|Baseline|WATCHMAN|WATCHMAN Left Atrial Appendage Closure Technology:
292063|NCT00129545|P3|Participant Flow|WARFARIN|Randomized to receive Warfarin control
292064|NCT00129545|P2|Participant Flow|WATCHMAN|Randomized to receive implantation of the WATCHMAN left atrial appendage (LAA) closure Technology
292065|NCT00129545|P1|Participant Flow|Roll-in|Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
292066|NCT00129545|O1|Outcome|WATCHMAN|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device
Implant of WATCHMAN Left Atrial Appendage Closure Technology"
292067|NCT00129545|O2|Outcome|Warfarin Control|"Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Warfarin: Subjects receive warfarin"
292068|NCT00129545|O1|Outcome|Implantable Device|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device
WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology"
292075|NCT00129623|B2|Baseline|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292076|NCT00129623|B1|Baseline|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292077|NCT00129623|P2|Participant Flow|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292078|NCT00129623|P1|Participant Flow|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292079|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292080|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292081|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292082|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292083|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia who were administered 150 mg IBN tablet orally (PO) once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
292084|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia who were administered matching placebo tablet PO once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
292085|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292086|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292087|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292088|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292089|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292090|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292126|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292127|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292128|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292091|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292092|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292093|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292094|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292095|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292096|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292097|NCT00129623|E2|Reported Event|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292098|NCT00129623|E1|Reported Event|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
292099|NCT00129727|B1|Baseline|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
292100|NCT00129727|P1|Participant Flow|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
292101|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
292102|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
292103|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
292104|NCT00129727|E1|Reported Event|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
292105|NCT00129766|B3|Baseline|Total|Total of all reporting groups
292106|NCT00129766|B2|Baseline|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292107|NCT00129766|B1|Baseline|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292108|NCT00129766|P2|Participant Flow|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292109|NCT00129766|P1|Participant Flow|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292110|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292111|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292112|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292113|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292114|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292115|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292116|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292117|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292118|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292119|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292120|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292121|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292122|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292123|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292124|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292129|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292130|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292131|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292132|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292133|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292134|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292135|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292136|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292137|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292138|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292139|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292140|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292141|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292142|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292143|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292144|NCT00129766|E2|Reported Event|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292145|NCT00129766|E1|Reported Event|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
292146|NCT00129961|B3|Baseline|Total|Total of all reporting groups
292147|NCT00129961|B2|Baseline|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292148|NCT00129961|B1|Baseline|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292149|NCT00129961|P2|Participant Flow|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292150|NCT00129961|P1|Participant Flow|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292151|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292217|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292152|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292153|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292154|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292155|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292156|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292157|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292158|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292218|NCT00130117|O2|Outcome|Oral Contraceptive Pills (OCPs)|"PLACEBO
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)"
292219|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292220|NCT00130117|O2|Outcome|Placebo|"placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)"
292159|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292160|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292161|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292162|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292163|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292164|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292165|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292221|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292222|NCT00130117|O2|Outcome|Placebo|"placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)"
292227|NCT00130117|O2|Outcome|Placebo|"placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)"
292166|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292167|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292168|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292169|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292170|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292171|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292172|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292223|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292224|NCT00130117|O2|Outcome|Placebo|"placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)"
292542|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292173|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292174|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292175|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292176|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292177|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292178|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292179|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292225|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292226|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292649|NCT00132314|P1|Participant Flow|Injectable Risperidone|long-acting injectable risperidone
292180|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292181|NCT00129961|E2|Reported Event|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
292182|NCT00129961|E1|Reported Event|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
292183|NCT00129974|B1|Baseline|Arm 1|Pemetrexed and Gemcitabine
292184|NCT00129974|P1|Participant Flow|Arm 1|Pemetrexed and Gemcitabine
292185|NCT00129974|O1|Outcome|Arm 1|Pemetrexed and Gemcitabine
292186|NCT00129974|O1|Outcome|Arm 1|Pemetrexed and Gemcitabine
292187|NCT00129974|E1|Reported Event|Arm 1|
292188|NCT00130039|B3|Baseline|Total|Total of all reporting groups
292189|NCT00130039|B2|Baseline|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
292190|NCT00130039|B1|Baseline|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
292191|NCT00130039|P2|Participant Flow|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
292192|NCT00130039|P1|Participant Flow|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
292193|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
292194|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
292195|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
292196|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
292197|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
292198|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
292199|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
292200|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
292201|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
292202|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
292203|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
292204|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
292205|NCT00130039|E2|Reported Event|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
292206|NCT00130039|E1|Reported Event|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
292207|NCT00130117|B3|Baseline|Total|Total of all reporting groups
292208|NCT00130117|B2|Baseline|Placebo|"placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)"
292209|NCT00130117|B1|Baseline|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292210|NCT00130117|P2|Participant Flow|Placebo|"placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)"
292211|NCT00130117|P1|Participant Flow|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292212|NCT00130117|O2|Outcome|Placebo|"placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)"
292213|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292214|NCT00130117|O2|Outcome|Placebo|"placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)"
292215|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292216|NCT00130117|O2|Outcome|Placebo|"placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)"
292228|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292229|NCT00130117|E2|Reported Event|Placebo|"placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)"
292230|NCT00130117|E1|Reported Event|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.
r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
292231|NCT00130247|B3|Baseline|Total|Total of all reporting groups
292232|NCT00130247|B2|Baseline|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
292233|NCT00130247|B1|Baseline|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
292234|NCT00130247|P2|Participant Flow|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
292235|NCT00130247|P1|Participant Flow|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
292236|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
292237|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
292238|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
292239|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
292240|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
292241|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
292242|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
292243|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
292244|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
292245|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
292246|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
292247|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
292248|NCT00130247|E2|Reported Event|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
292249|NCT00130247|E1|Reported Event|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
292250|NCT00130286|B5|Baseline|Total|Total of all reporting groups
292251|NCT00130286|B4|Baseline|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292252|NCT00130286|B3|Baseline|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292253|NCT00130286|B2|Baseline|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292254|NCT00130286|B1|Baseline|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292255|NCT00130286|P4|Participant Flow|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292256|NCT00130286|P3|Participant Flow|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292257|NCT00130286|P2|Participant Flow|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292258|NCT00130286|P1|Participant Flow|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292259|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292260|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292261|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292262|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292263|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292264|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292265|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292266|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292267|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292268|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292269|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292270|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292271|NCT00130286|E4|Reported Event|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292272|NCT00130286|E3|Reported Event|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292273|NCT00130286|E2|Reported Event|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292274|NCT00130286|E1|Reported Event|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
292275|NCT00130520|B1|Baseline|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
292276|NCT00130520|P1|Participant Flow|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
292277|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
292278|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
292279|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
292345|NCT00130923|O2|Outcome|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
292662|NCT00132496|O1|Outcome|Rabeprazole 10 mg|once daily for 8 weeks
292280|NCT00130520|E1|Reported Event|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
292281|NCT00130637|B1|Baseline|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
292282|NCT00130637|P1|Participant Flow|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
292283|NCT00130637|O1|Outcome|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
292284|NCT00130637|O1|Outcome|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
292285|NCT00130637|E1|Reported Event|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
292286|NCT00130689|B1|Baseline|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
292287|NCT00130689|P1|Participant Flow|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
292288|NCT00130689|O1|Outcome|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
292289|NCT00130689|E1|Reported Event|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
292290|NCT00130728|B3|Baseline|Total|Total of all reporting groups
292291|NCT00130728|B2|Baseline|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
292292|NCT00130728|B1|Baseline|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
292293|NCT00130728|P2|Participant Flow|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
292294|NCT00130728|P1|Participant Flow|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
292295|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
292296|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
292297|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
292298|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
292299|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
292300|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
292301|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
292302|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
292303|NCT00130728|E2|Reported Event|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
292304|NCT00130728|E1|Reported Event|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
292305|NCT00130780|B3|Baseline|Total|Total of all reporting groups
292538|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292650|NCT00132314|O2|Outcome|Oral Antipsychotic|oral antipsychotic medication
292306|NCT00130780|B2|Baseline|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab
Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
292307|NCT00130780|B1|Baseline|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy
Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
292308|NCT00130780|P2|Participant Flow|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab
Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
292309|NCT00130780|P1|Participant Flow|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy
Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
292310|NCT00130780|O2|Outcome|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab
Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
292311|NCT00130780|O1|Outcome|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy
Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
292312|NCT00130780|E2|Reported Event|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab
Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
292539|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292651|NCT00132314|O1|Outcome|Injectable Risperidone|long-acting injectable risperidone
292313|NCT00130780|E1|Reported Event|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy
Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
292314|NCT00130793|B3|Baseline|Total|Total of all reporting groups
292315|NCT00130793|B2|Baseline|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
292316|NCT00130793|B1|Baseline|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
292317|NCT00130793|P2|Participant Flow|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
292318|NCT00130793|P1|Participant Flow|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
292319|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
292320|NCT00130793|O1|Outcome|ZOSTAVAX™With PGSU|ZOSTAVAX™with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
292321|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
292322|NCT00130793|O1|Outcome|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
292323|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
292324|NCT00130793|O1|Outcome|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
292325|NCT00130793|E2|Reported Event|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
292326|NCT00130793|E1|Reported Event|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
292327|NCT00130832|B3|Baseline|Total|Total of all reporting groups
292328|NCT00130832|B2|Baseline|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
292329|NCT00130832|B1|Baseline|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
292330|NCT00130832|P2|Participant Flow|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
292331|NCT00130832|P1|Participant Flow|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
292332|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
292333|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
292334|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
292335|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
292336|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
292337|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
292338|NCT00130832|E2|Reported Event|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
292339|NCT00130832|E1|Reported Event|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
292340|NCT00130923|B3|Baseline|Total|Total of all reporting groups
292341|NCT00130923|B2|Baseline|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
292342|NCT00130923|B1|Baseline|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
292343|NCT00130923|P2|Participant Flow|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
292344|NCT00130923|P1|Participant Flow|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
292540|NCT00131664|O2|Outcome|Avandamet|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292346|NCT00130923|O1|Outcome|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
292347|NCT00130923|E2|Reported Event|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
292348|NCT00130923|E1|Reported Event|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
292349|NCT00131248|B1|Baseline|All Study Participants|
292350|NCT00131248|P2|Participant Flow|Placebo, Medications, Placebo (Group 2)|"received 3-day course placebo, followed by 7-day course anti-reflux medication, followed by 4-day course placebo.
All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes."
292351|NCT00131248|P1|Participant Flow|Medications, Placebo, Medications (Group 1)|"3-day course of anti-reflux medications, followed by 7-day course placebo, followed by 4-day course anti-reflux medications.
All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes."
292352|NCT00131248|O2|Outcome|Placebo|
292353|NCT00131248|O1|Outcome|Medications|
292354|NCT00131248|E2|Reported Event|Placebo|
292355|NCT00131248|E1|Reported Event|Medications|
292356|NCT00131352|B3|Baseline|Total|Total of all reporting groups
292357|NCT00131352|B2|Baseline|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
292358|NCT00131352|B1|Baseline|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
292359|NCT00131352|P2|Participant Flow|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the Initial Treatment Period.
292360|NCT00131352|P1|Participant Flow|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period. Participants from both treatment arms had the opportunity to receive an additional 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period.
292361|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
292362|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
292363|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
292364|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
292365|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
292366|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
292367|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
292368|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
292369|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
292370|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
292371|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
292372|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
292373|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
292374|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
292375|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
292376|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
292377|NCT00131352|E4|Reported Event|Synvisc (From Saline Control) - Repeat Treatment Period|Participants from the Saline Control Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
292378|NCT00131352|E3|Reported Event|Synvisc - Repeat Treatment Period|Participants from the Synvisc Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
292379|NCT00131352|E2|Reported Event|Saline Control - Initial Treatment Period|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the initial treatment period.
292380|NCT00131352|E1|Reported Event|Synvisc - Initial Treatment Period|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period (up to week 26).
292381|NCT00131378|B5|Baseline|Total|Total of all reporting groups
292382|NCT00131378|B4|Baseline|Male on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292383|NCT00131378|B3|Baseline|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292384|NCT00131378|B2|Baseline|Female on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292385|NCT00131378|B1|Baseline|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292386|NCT00131378|P4|Participant Flow|Male on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292387|NCT00131378|P3|Participant Flow|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292388|NCT00131378|P2|Participant Flow|Female on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292389|NCT00131378|P1|Participant Flow|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292390|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292391|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292392|NCT00131378|O2|Outcome|Female on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292393|NCT00131378|O1|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292394|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292395|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292396|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292397|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292398|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292399|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292400|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292401|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292402|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292403|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292404|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292405|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292406|NCT00131378|E4|Reported Event|Male on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292407|NCT00131378|E3|Reported Event|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292408|NCT00131378|E2|Reported Event|Female on Placebo|"Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
292409|NCT00131378|E1|Reported Event|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
292410|NCT00131456|B3|Baseline|Total|Total of all reporting groups
292411|NCT00131456|B2|Baseline|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
292412|NCT00131456|B1|Baseline|Placebo|Matched Placebo
292413|NCT00131456|P2|Participant Flow|Venlafaxine|"Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day."
292414|NCT00131456|P1|Participant Flow|Placebo|Matched Placebo
292415|NCT00131456|O2|Outcome|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
292416|NCT00131456|O1|Outcome|Placebo|Matched Placebo
292417|NCT00131456|E2|Reported Event|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
292418|NCT00131456|E1|Reported Event|Placebo|Matched Placebo
292419|NCT00131508|B3|Baseline|Total|Total of all reporting groups
292420|NCT00131508|B2|Baseline|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292421|NCT00131508|B1|Baseline|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292422|NCT00131508|P2|Participant Flow|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292423|NCT00131508|P1|Participant Flow|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292424|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292425|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292426|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292427|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292428|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292429|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292430|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292431|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292432|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292433|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292434|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292435|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292436|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292437|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292438|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292439|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292440|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292441|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292442|NCT00131508|E2|Reported Event|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
292443|NCT00131508|E1|Reported Event|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
292444|NCT00131573|B3|Baseline|Total|Total of all reporting groups
292445|NCT00131573|B2|Baseline|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
292446|NCT00131573|B1|Baseline|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
292447|NCT00131573|P2|Participant Flow|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.
Stimulation On from 45 days post 12 month visit and on."
292448|NCT00131573|P1|Participant Flow|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
292449|NCT00131573|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
292450|NCT00131573|O1|Outcome|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
292451|NCT00131573|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
292541|NCT00131664|O1|Outcome|Avandia and Amaryl|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292826|NCT00132873|B1|Baseline|Xyrem (Sodium Oxybate)|
292452|NCT00131573|O1|Outcome|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.
Stimulation On from 45 days post 12 month visit and on."
292453|NCT00131573|E2|Reported Event|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
292454|NCT00131573|E1|Reported Event|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
292455|NCT00124449|B3|Baseline|Total|Total of all reporting groups
292456|NCT00124449|B2|Baseline|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292457|NCT00124449|B1|Baseline|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292458|NCT00124449|P2|Participant Flow|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292459|NCT00124449|P1|Participant Flow|Abatacept|Abatacept by intravenous (IV) infusion, dose based on participant’s body weight at the screening visit
292460|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292461|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292462|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292463|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292464|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292465|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292466|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292467|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292468|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292469|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292470|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
292471|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292472|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
292473|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292474|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292475|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292476|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292477|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292478|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292479|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292480|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292481|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292482|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
292483|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292484|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292485|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292486|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
292487|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
292488|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
292489|NCT00124449|E2|Reported Event|Placebo|
292490|NCT00124449|E1|Reported Event|BMS-188667|
292491|NCT00124462|B3|Baseline|Total|Total of all reporting groups
292492|NCT00124462|B2|Baseline|Placebo to Realignment|"Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole.
Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear"
292493|NCT00124462|B1|Baseline|Realignment to Placebo|Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear Non realigning knee brace and flat orthodic: A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
292494|NCT00124462|P2|Participant Flow|Placebo to Realignment|"Placebo/Control Knee brace and Shoe Insert- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole.
Realignment/Experimental Knee Brace and Shoe Insert- A valgus brace, customized functional orthodic for neutral foot position and motion control footwear."
292495|NCT00124462|P1|Participant Flow|Realignment to Placebo|"Realignment/Experimental Knee Brace and Shoe Insert- A valgus brace, customized functional orthodic for neutral foot position and motion control footwear.
Placebo/Control Knee brace and Shoe Insert- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole"
292496|NCT00124462|O2|Outcome|Placebo to Realignment|"Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole.
Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear"
292497|NCT00124462|O1|Outcome|Realignment to Placebo|Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear Non realigning knee brace and flat orthodic: A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
292498|NCT00124462|O2|Outcome|Placebo to Realignment|"Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole.
Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear"
292499|NCT00124462|O1|Outcome|Realignment to Placebo|Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear Non realigning knee brace and flat orthodic: A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
292500|NCT00124462|E2|Reported Event|Placebo to Realignment|Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
292501|NCT00124462|E1|Reported Event|Realignment to Placebo|"Realigning knee brace and custom orthodic- A valgus brace, customized functional orthotic for neutral foot position and motion control footwear.
Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear"
292502|NCT00131664|B4|Baseline|Total|Total of all reporting groups
292503|NCT00131664|B3|Baseline|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292504|NCT00131664|B2|Baseline|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292505|NCT00131664|B1|Baseline|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292506|NCT00131664|P6|Participant Flow|Metformin and Amaryl|Metformin Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months.
292507|NCT00131664|P5|Participant Flow|Avandamet and Amaryl|Avandamet™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months
292508|NCT00131664|P4|Participant Flow|Avandia, Amaryl and Metformin|Avandia™ + Amaryl™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Metformin was added and titrated up to 1000 mg twice daily (BID) maximum dose for an additional 6 months.
292509|NCT00131664|P3|Participant Flow|Metformin|Metformin Arm: initial dose of 500 mg twice daily (BID) was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID.
292510|NCT00131664|P2|Participant Flow|Avandamet|Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg twice daily (BID) was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID.
292511|NCT00131664|P1|Participant Flow|Avandia and Amaryl|Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg + 1 mg once daily (OD) was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg + 2 mg OD.
292512|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292513|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292514|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292515|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292516|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292517|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292518|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292519|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292520|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292521|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292522|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292523|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292524|NCT00131664|O3|Outcome|Metformin|: 500 mg twice daily titration up to 1000 mg twice daily over 6 months
292525|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292526|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292527|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292528|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292529|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292530|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292531|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292532|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292533|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292534|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292535|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292536|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292537|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292543|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292544|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292545|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292546|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292547|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292548|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292549|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292550|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292551|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292552|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292553|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292554|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292555|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292556|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292557|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292558|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292559|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292560|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292561|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292562|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292563|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
292564|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
292565|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
292566|NCT00131664|E3|Reported Event|Metformin|Metformin Arm: initial dose of 500 mg BID was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID. At month 6 (visit 6), patients not achieving target received additional specified drug therapy: Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months.
292567|NCT00131664|E2|Reported Event|Avandamet|Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg BID was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID. At month 6, patients not achieving target received additional specified drug therapy Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months
292568|NCT00131664|E1|Reported Event|Avandia and Amaryl|Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg +1 mg OD was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg / 2 mg OD. At month 6, patients not achieving target received additional specified drug therapy: Metformin was added and titrated up to 1000 mg BID maximum dose for an additional 6 months.
292569|NCT00131677|B3|Baseline|Total|Total of all reporting groups
292570|NCT00131677|B2|Baseline|Placebo|Placebo arm--received matching placebo
292571|NCT00131677|B1|Baseline|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
292572|NCT00131677|P2|Participant Flow|Placebo|Participants received matching placebo, to be taken daily.
292573|NCT00131677|P1|Participant Flow|Tenofovir Disoproxil Fumarate|Participants received TDF 300mg orally daily for 24 months (immediate arm) or 15 months (delayed arm).
292574|NCT00131677|O2|Outcome|Placebo|Placebo arm--received matching placebo
292575|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
292576|NCT00131677|O2|Outcome|Placebo|Placebo arm--received matching placebo
292577|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
292578|NCT00131677|O1|Outcome|All Enrolled Participants|
292579|NCT00131677|O1|Outcome|Treatment Emergent Cohort|Includes all who entered treatment emergent cohort (active and placebo arms)
292580|NCT00131677|O2|Outcome|Placebo|Matching placebo daily
292581|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|TDF, 300 mg orally daily.
292582|NCT00131677|O2|Outcome|Placebo|Matching placebo daily
292583|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|TDF, 300 mg orally daily
292584|NCT00131677|E2|Reported Event|Placebo|Matching placebo daily
292585|NCT00131677|E1|Reported Event|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
292586|NCT00131885|B5|Baseline|Total|Total of all reporting groups
292587|NCT00131885|B4|Baseline|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292588|NCT00131885|B3|Baseline|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
292589|NCT00131885|B2|Baseline|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292652|NCT00132314|O2|Outcome|Oral Antipsychotic|oral antipsychotic medication
292827|NCT00132873|P1|Participant Flow|Xyrem (Sodium Oxybate)|
292590|NCT00131885|B1|Baseline|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292591|NCT00131885|P4|Participant Flow|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292592|NCT00131885|P3|Participant Flow|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
292593|NCT00131885|P2|Participant Flow|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292594|NCT00131885|P1|Participant Flow|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292595|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292596|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
292597|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292598|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292599|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292600|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
292601|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292602|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292603|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292604|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
292605|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292606|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292607|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292608|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
292609|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292610|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292611|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292612|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
292613|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292614|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292615|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292616|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
292617|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292618|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292619|NCT00131885|E4|Reported Event|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292620|NCT00131885|E3|Reported Event|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
292621|NCT00131885|E2|Reported Event|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292622|NCT00131885|E1|Reported Event|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
292623|NCT00131911|B3|Baseline|Total|Total of all reporting groups
292624|NCT00131911|B2|Baseline|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292625|NCT00131911|B1|Baseline|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292626|NCT00131911|P2|Participant Flow|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292627|NCT00131911|P1|Participant Flow|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292628|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292629|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292630|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292631|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292632|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292633|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292634|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292635|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292636|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292637|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292638|NCT00131911|E1|Reported Event|All Patients|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
292639|NCT00131937|B1|Baseline|Treatment (Sorafenib)|"Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given orally"
292640|NCT00131937|P1|Participant Flow|Treatment (Sorafenib)|"Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given orally"
292641|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given orally"
292642|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given orally"
292643|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Given orally"
292644|NCT00131937|E1|Reported Event|Treatment (Sorafenib)|All patients who received Sorafenib treatment.
292645|NCT00132314|B3|Baseline|Total|Total of all reporting groups
292646|NCT00132314|B2|Baseline|Oral Antipsychotic|oral antipsychotic medication
292647|NCT00132314|B1|Baseline|Injectable Risperidone|long-acting injectable risperidone
292648|NCT00132314|P2|Participant Flow|Oral Antipsychotic|oral antipsychotic medication
292663|NCT00132496|E2|Reported Event|Rabeprazole 20 mg|once daily for 8 weeks
292664|NCT00132496|E1|Reported Event|Rabeprazole 10 mg|once daily for 8 weeks
292665|NCT00132678|B3|Baseline|Total|Total of all reporting groups
292666|NCT00132678|B2|Baseline|Placebo|IM injection every 2 weeks
292667|NCT00132678|B1|Baseline|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
292668|NCT00132678|P3|Participant Flow|Open-Label Oral Risperidone|(flexible dosage) 1 to 6 mg/day for the first 3 weeks
292669|NCT00132678|P2|Participant Flow|Placebo|intramuscular (IM) injection every 2 weeks
292670|NCT00132678|P1|Participant Flow|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks
292671|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
292672|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
292673|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
292674|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
292675|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
292676|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
292677|NCT00132678|E4|Reported Event|Open Label RISPERDAL CONSTA|Open-label Period III. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks.
292678|NCT00132678|E3|Reported Event|Open-Label Oral Risperidone|Open-label Period II. Flexible dosage. 1 to 6 mg/day for the first 3 weeks
292679|NCT00132678|E2|Reported Event|Placebo|Double-blind Period IV. Intramuscular (IM) injection every 2 weeks
292680|NCT00132678|E1|Reported Event|RISPERDAL CONSTA|Double-blind Period IV. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks.
292681|NCT00132691|B3|Baseline|Total|Total of all reporting groups
292682|NCT00132691|B2|Baseline|Standard Systemic Treatment|Systemic corticosteroid therapy with immunosuppression as indicated
292683|NCT00132691|B1|Baseline|Flucinolone Acetonide Intraocular Implant|Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
292684|NCT00132691|P2|Participant Flow|Standard Systemic Treatment|Systemic corticosteroid therapy with immunosuppression as indicated
292685|NCT00132691|P1|Participant Flow|Flucinolone Acetonide Intraocular Implant|Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
292686|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
292687|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
292688|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
292689|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
292690|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
292691|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
292692|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
292693|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
292694|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
292695|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
292696|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
292697|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
292698|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
292699|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
292700|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
292701|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
292702|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
292703|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
292704|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
292705|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy
292706|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
292707|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
292708|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
292709|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
292710|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
292711|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
292712|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
292713|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
292714|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
292715|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
292716|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
292717|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
292828|NCT00132873|O1|Outcome|Xyrem (Sodium Oxybate)|
292829|NCT00132873|O1|Outcome|Xyrem (Sodium Oxybate)|
292830|NCT00132873|E1|Reported Event|Xyrem (Sodium Oxybate)|
292718|NCT00132691|O2|Outcome|Systemic Therapy|Oral corticosteroids supplemented with immunosuppressive drugs if indicated were given according to published guidelines developed by an expert panel. For participants with active uveitis at baseline, 1 mg/kg/day up to 60 mg/day of prednisone was given until uveitis was controlled or 4 weeks had elapsed. When control was achieved, prednisone was tapered per study guidelines. Immunosuppressive drugs were added when uveitis was not initially controlled with prednisone alone, as corticosteroid-sparing agents when prednisone could not be tapered to 10 mg/day without reactivation of uveitis and for specific uveitis syndromes. Choice of immunosuppressant was made by the study ophthalmologist; immunosuppressant administration and monitoring for toxicity was conducted according to expert guidelines.
292719|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|A fluocinolone acetonide intravitreal implant (0.59 mg) was surgically placed by a study-certified surgeon was placed in each eligible eye. The first eye was implanted within 28 days of randomization and, if eligible, the second eye within the next 28 days. Prior to implant surgery, topical, periocular or systemic corticosteroids where used as needed to quiet the anterior chamber. Post-implant, systemic corticosteroids and immunosuppressive drugs were tapered and discontinued. If the second eye was not eligible for an implant initially but later became eligible, an implant was placed in the second eye at that time. The treatment algorithm included re-implantation upon reactivation and treatment per best medical judgment for failure to achieve inflammation control, treatment-limiting toxicity and systemic disease requiring systemic therapy.
292720|NCT00132691|E2|Reported Event|Systemic Therapy|Participants randomized to receive systemic therapy.
292721|NCT00132691|E1|Reported Event|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
292722|NCT00132730|B5|Baseline|Total|Total of all reporting groups
292723|NCT00132730|B4|Baseline|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
292724|NCT00132730|B3|Baseline|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292725|NCT00132730|B2|Baseline|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292726|NCT00132730|B1|Baseline|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292727|NCT00132730|P6|Participant Flow|Usual Care|Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
292728|NCT00132730|P5|Participant Flow|MK-0873 2.5 mg + Usual Care|Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
292729|NCT00132730|P4|Participant Flow|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
292730|NCT00132730|P3|Participant Flow|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292731|NCT00132730|P2|Participant Flow|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
292732|NCT00132730|P1|Participant Flow|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
292733|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
292734|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292735|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292736|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292737|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
292738|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292739|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292740|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292741|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
292742|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292743|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292744|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292745|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
292746|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292747|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292748|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292749|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
292750|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292751|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292752|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292753|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
292754|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292755|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292756|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292757|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
292758|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292759|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292760|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292761|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
292762|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292763|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292764|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292765|NCT00132730|E8|Reported Event|Usual Care EXT2|Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
292766|NCT00132730|E7|Reported Event|MK-0873 2.5 mg + Usual Care EXT 2|Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
292767|NCT00132730|E6|Reported Event|Placebo EXT 1|Participants receive placebo tablets once daily for 12 weeks in Period III (EXT1)
292768|NCT00132730|E5|Reported Event|MK-0873 2.5 mg EXT 1|Participants receive MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292769|NCT00132730|E4|Reported Event|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
292831|NCT00133575|B8|Baseline|Total|Total of all reporting groups
292832|NCT00133575|B7|Baseline|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292770|NCT00132730|E3|Reported Event|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
292771|NCT00132730|E2|Reported Event|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
292772|NCT00132730|E1|Reported Event|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
292773|NCT00132769|B3|Baseline|Total|Total of all reporting groups
292774|NCT00132769|B2|Baseline|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292775|NCT00132769|B1|Baseline|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292776|NCT00132769|P2|Participant Flow|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292777|NCT00132769|P1|Participant Flow|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292778|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292779|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292780|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292781|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292782|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292783|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292784|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292785|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292786|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292787|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292788|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292789|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292790|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292791|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292792|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292793|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292794|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292795|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292796|NCT00132769|E2|Reported Event|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
292797|NCT00132769|E1|Reported Event|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
292798|NCT00132808|B4|Baseline|Total|Total of all reporting groups
292799|NCT00132808|B3|Baseline|Placebo|Placebo given at randomization and Month 12
292800|NCT00132808|B2|Baseline|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
292801|NCT00132808|B1|Baseline|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
292802|NCT00132808|P3|Participant Flow|Placebo|Placebo given at randomization and Month 12
292803|NCT00132808|P2|Participant Flow|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
292804|NCT00132808|P1|Participant Flow|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
292805|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
292806|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
292807|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
292808|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
292809|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
292810|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
292811|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
292812|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
292813|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
292814|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
292815|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
292816|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
292817|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
292818|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
292819|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
292820|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
292821|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
292822|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
292823|NCT00132808|E3|Reported Event|Placebo|Placebo given at randomization and Month 12
292824|NCT00132808|E2|Reported Event|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
292825|NCT00132808|E1|Reported Event|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
292833|NCT00133575|B6|Baseline|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292834|NCT00133575|B5|Baseline|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292835|NCT00133575|B4|Baseline|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292836|NCT00133575|B3|Baseline|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292837|NCT00133575|B2|Baseline|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292838|NCT00133575|B1|Baseline|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292839|NCT00133575|P7|Participant Flow|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292840|NCT00133575|P6|Participant Flow|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292841|NCT00133575|P5|Participant Flow|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292842|NCT00133575|P4|Participant Flow|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292843|NCT00133575|P3|Participant Flow|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292844|NCT00133575|P2|Participant Flow|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292845|NCT00133575|P1|Participant Flow|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292846|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292847|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292848|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292849|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292850|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292851|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292852|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292853|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292854|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292855|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292856|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292857|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292858|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292859|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292860|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292861|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292862|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292863|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292864|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292865|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292866|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292867|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292868|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292869|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292870|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292871|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292872|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292873|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292874|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292875|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292876|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292877|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292878|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292879|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292880|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292881|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292882|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292883|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292884|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292885|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292886|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292887|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292888|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292889|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292890|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292891|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292892|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292893|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292894|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292895|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292896|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292897|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292898|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292899|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292900|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292901|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292902|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292903|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292904|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292905|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292906|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292907|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292908|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292909|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292910|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
293070|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
292911|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292912|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292913|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292914|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292915|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292916|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292917|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292918|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292919|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292920|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292921|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292922|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292923|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292924|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292925|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292926|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292927|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292928|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292929|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292930|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292931|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292932|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292933|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292934|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292935|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292936|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292937|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292938|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292939|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292940|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292941|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292942|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292943|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292944|NCT00133575|E7|Reported Event|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
292945|NCT00133575|E6|Reported Event|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292946|NCT00133575|E5|Reported Event|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292947|NCT00133575|E4|Reported Event|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292948|NCT00133575|E3|Reported Event|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
292949|NCT00133575|E2|Reported Event|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
292950|NCT00133575|E1|Reported Event|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
292951|NCT00133705|B3|Baseline|Total|Total of all reporting groups
292952|NCT00133705|B2|Baseline|Placebo|Twenty women received a placebo pill daily.
292953|NCT00133705|B1|Baseline|Mifepristone 5 mg.|Twenty-two women received 5 mg. mifepristone daily.
292954|NCT00133705|P2|Participant Flow|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
292955|NCT00133705|P1|Participant Flow|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
292956|NCT00133705|O2|Outcome|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
292957|NCT00133705|O1|Outcome|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
292958|NCT00133705|E2|Reported Event|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
292959|NCT00133705|E1|Reported Event|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
292960|NCT00133809|B1|Baseline|Islet Transplant|"10 subjects were found eligible and were can be matched to an appropriate donor will receive/have received an islet transplant---1 INELIGIBLE WHILE ON WAITLIST.
Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
292961|NCT00133809|P1|Participant Flow|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant
Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
292962|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant
Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
292963|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant
Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
292964|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant
Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
292965|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant
Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
292966|NCT00133809|E1|Reported Event|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant
Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
292967|NCT00133952|B3|Baseline|Total|Total of all reporting groups
292968|NCT00133952|B2|Baseline|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292969|NCT00133952|B1|Baseline|Placebo|Taken orally daily for up to 48 months
292970|NCT00133952|P2|Participant Flow|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292971|NCT00133952|P1|Participant Flow|Placebo|Taken orally daily for up to 48 months
292972|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292973|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
292974|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292975|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
292976|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292977|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
292978|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292979|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
292980|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292981|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
292982|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292983|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
292984|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292985|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
292986|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292987|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
292988|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292989|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
292990|NCT00133952|E2|Reported Event|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
292991|NCT00133952|E1|Reported Event|Placebo|Taken orally daily for up to 48 months
292992|NCT00133978|B5|Baseline|Total|Total of all reporting groups
292993|NCT00133978|B4|Baseline|Placebo|Non-isonitrogenic, iso-caloric placebo solution
292994|NCT00133978|B3|Baseline|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
292995|NCT00133978|B2|Baseline|Antioxidants|Antioxidant supplementation
292996|NCT00133978|B1|Baseline|Glutamine|Glutamine supplementation
292997|NCT00133978|P4|Participant Flow|Placebo|Non-isonitrogenic, iso-caloric placebo solution
293071|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
293072|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
292998|NCT00133978|P3|Participant Flow|Glutamine + Antioxidants|"Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
500 ug of selenium intravenously , and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg."
292999|NCT00133978|P2|Participant Flow|Antioxidants|Antioxidant supplementation 500 ug of selenium intravenously, and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
293000|NCT00133978|P1|Participant Flow|Glutamine|Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
293001|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
293002|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
293003|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
293004|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
293005|NCT00133978|O4|Outcome|No Antioxidants|Non-isonitrogenic, iso-caloric placebo solution
293006|NCT00133978|O3|Outcome|Antioxidants|500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
293007|NCT00133978|O2|Outcome|No Glutamine|Non-isonitrogenic, iso-caloric placebo solution
293008|NCT00133978|O1|Outcome|Glutamine|0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
293009|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
293010|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
293011|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
293012|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
293013|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
293014|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
293015|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
293016|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
293017|NCT00133978|E4|Reported Event|Placebo|Non-isonitrogenic, iso-caloric placebo solution
293018|NCT00133978|E3|Reported Event|Glutamine + Antioxidants|"Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg."
293019|NCT00133978|E2|Reported Event|Antioxidants|Antioxidant supplementation 500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
293020|NCT00133978|E1|Reported Event|Glutamine|Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
293021|NCT00134004|B1|Baseline|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
293022|NCT00134004|P1|Participant Flow|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
293023|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
293024|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
293025|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
293026|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
293027|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
293028|NCT00134004|E1|Reported Event|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
293029|NCT00134043|B3|Baseline|Total|Total of all reporting groups
293030|NCT00134043|B2|Baseline|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
vorinostat: Given orally"
293073|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
293074|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
293075|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
293031|NCT00134043|B1|Baseline|DTCs (Well-differentiated Thyroid Carcinomas)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
vorinostat: Given orally"
293032|NCT00134043|P2|Participant Flow|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
vorinostat: Given orally"
293033|NCT00134043|P1|Participant Flow|DTCs (Well-differentiated Thyroid Carcinomas)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
vorinostat: Given orally"
293034|NCT00134043|O2|Outcome|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
vorinostat: Given orally"
293035|NCT00134043|O1|Outcome|DTCs (Well-differentiated Thyroid Carcinomas)|Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
293036|NCT00134043|E1|Reported Event|Arm I & Arm II|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
vorinostat: Given orally"
293037|NCT00134056|B3|Baseline|Total|Total of all reporting groups
293038|NCT00134056|B2|Baseline|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
atrasentan hydrochloride: Given orally
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally"
293039|NCT00134056|B1|Baseline|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally
placebo: Given orally"
293040|NCT00134056|P2|Participant Flow|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
atrasentan hydrochloride: Given orally
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally"
293041|NCT00134056|P1|Participant Flow|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally
placebo: Given orally"
293042|NCT00134056|O2|Outcome|Arm II: Atrasentan Hydrochloride|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
atrasentan hydrochloride: Given orally
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally"
293043|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally
placebo: Given orally"
293044|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
atrasentan hydrochloride: Given orally
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally"
293045|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally
placebo: Given orally"
293046|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
atrasentan hydrochloride: Given orally
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally"
293047|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally
placebo: Given orally"
293048|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
atrasentan hydrochloride: Given orally
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally"
293049|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally
placebo: Given orally"
293050|NCT00134056|O2|Outcome|Arm II: Atrasentan|Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
293051|NCT00134056|O1|Outcome|Arm I: Placebo|Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
293052|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
atrasentan hydrochloride: Given orally
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally"
293053|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally
placebo: Given orally"
293054|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
atrasentan hydrochloride: Given orally
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally"
293055|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally
placebo: Given orally"
293056|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
atrasentan hydrochloride: Given orally
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally"
293057|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
docetaxel: Docetaxel given IV and prednisone given orally
prednisone: Docetaxel given IV and prednisone given orally
placebo: Given orally"
293058|NCT00134056|E2|Reported Event|Arm II: Atrasentan|Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
293059|NCT00134056|E1|Reported Event|Arm I: Placebo|Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
293060|NCT00134563|B4|Baseline|Total|Total of all reporting groups
293061|NCT00134563|B3|Baseline|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
293062|NCT00134563|B2|Baseline|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
293063|NCT00134563|B1|Baseline|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
293064|NCT00134563|P3|Participant Flow|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
293065|NCT00134563|P2|Participant Flow|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
293066|NCT00134563|P1|Participant Flow|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
293067|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
293068|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
293069|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
293076|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
293077|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
293078|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
293079|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
293080|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
293081|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
293082|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
293083|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
293084|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
293085|NCT00134563|E3|Reported Event|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
293086|NCT00134563|E2|Reported Event|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
293087|NCT00134563|E1|Reported Event|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
293088|NCT00134719|B4|Baseline|Total|Total of all reporting groups
293089|NCT00134719|B3|Baseline|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293090|NCT00134719|B2|Baseline|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293091|NCT00134719|B1|Baseline|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293092|NCT00134719|P3|Participant Flow|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293093|NCT00134719|P2|Participant Flow|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293094|NCT00134719|P1|Participant Flow|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293095|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293096|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293097|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293098|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293099|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293100|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293101|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293102|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293103|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293104|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293105|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293106|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293107|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293108|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293109|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293110|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293226|NCT00134784|P4|Participant Flow|Levodopa 600 mg/Day|Levodopa 600/day, [123I]ß-CIT and SPECT imaging
293111|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293112|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293113|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293114|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293115|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293116|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293117|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293118|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293119|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293120|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293121|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293122|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293123|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293124|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293125|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293126|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293127|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293128|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293129|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293130|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293131|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293132|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293133|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293134|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293135|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293136|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293137|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293138|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293139|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293140|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293141|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293142|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293143|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293144|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293145|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293146|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293147|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293148|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293149|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293150|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293151|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293152|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293153|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293154|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293155|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293156|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293157|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293158|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293159|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293160|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293161|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293162|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293163|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293164|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293165|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293166|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293167|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293168|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293169|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293170|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293171|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293172|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293173|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293174|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293175|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293176|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293177|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293178|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293179|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293180|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293181|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293182|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293183|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293184|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293185|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293186|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293187|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293188|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293189|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293190|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293191|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293192|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293193|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293194|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293195|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293196|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293197|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293198|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293199|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293200|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293201|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293202|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293203|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293204|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293205|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293206|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293207|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293208|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293209|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293210|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293211|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293212|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293213|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293214|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293215|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293216|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293217|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293218|NCT00134719|E3|Reported Event|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
293219|NCT00134719|E2|Reported Event|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293220|NCT00134719|E1|Reported Event|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
293221|NCT00134784|B5|Baseline|Total|Total of all reporting groups
293222|NCT00134784|B4|Baseline|Levodopa 600 mg/Day|Subjects on Levodopa 600 mg/day
293223|NCT00134784|B3|Baseline|Levodopa 300 mg/Day|Subjects on 300 mg/day of Levodopa
293224|NCT00134784|B2|Baseline|Levodopa 150mg/Day|Subjects on 150mg/day of Levodopa
293225|NCT00134784|B1|Baseline|Placebo Group|Subjects on placebo
328473|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
293227|NCT00134784|P3|Participant Flow|Levodopa 300 mg/Day|Levodopa 300mg/day, [123I]ß-CIT and SPECT imaging
293228|NCT00134784|P2|Participant Flow|Levodopa 150mg/Day|Levodopa 150mg/day, [123I]ß-CIT and SPECT imaging
293229|NCT00134784|P1|Participant Flow|Placebo|Placebo group
293230|NCT00134784|O4|Outcome|Levodopa 3|Subjects on 600 mg/day of Levodopa
293231|NCT00134784|O3|Outcome|Levodopa 2|Subjects on 300 mg/day of Levodopa
293232|NCT00134784|O2|Outcome|Levodopa|Subjects on 150 mg/day of Levodopa
293233|NCT00134784|O1|Outcome|Placebo Group|Participants receiving placebo
293234|NCT00134784|E1|Reported Event|I123BCIT|[123I]ß CIT and SPECT imaging' .
293235|NCT00127530|B3|Baseline|Total|Total of all reporting groups
293236|NCT00127530|B2|Baseline|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
293237|NCT00127530|B1|Baseline|Placebo- Sugar Pill|Placebo control group
293238|NCT00127530|P2|Participant Flow|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
293239|NCT00127530|P1|Participant Flow|Placebo- Sugar Pill|Placebo control group
293240|NCT00127530|O2|Outcome|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
293241|NCT00127530|O1|Outcome|Placebo- Sugar Pill|Placebo control group
293242|NCT00127530|E2|Reported Event|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
293243|NCT00127530|E1|Reported Event|Placebo- Sugar Pill|Placebo control group
293261|NCT00127712|B3|Baseline|Total|Total of all reporting groups
293262|NCT00127712|B2|Baseline|Control|Control group
293263|NCT00127712|B1|Baseline|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
293264|NCT00127712|P2|Participant Flow|Control|Control group
293265|NCT00127712|P1|Participant Flow|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
293266|NCT00127712|O2|Outcome|Control|Control group
293267|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
293268|NCT00127712|O2|Outcome|Control|Control group
293269|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
293270|NCT00127712|O2|Outcome|Control|Control group
293271|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
293272|NCT00127712|O2|Outcome|Control|Control group
293273|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
293274|NCT00127712|E2|Reported Event|Control|Control group
293275|NCT00127712|E1|Reported Event|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
293276|NCT00127790|B5|Baseline|Total|Total of all reporting groups
293277|NCT00127790|B4|Baseline|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
293278|NCT00127790|B3|Baseline|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293279|NCT00127790|B2|Baseline|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293280|NCT00127790|B1|Baseline|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
293281|NCT00127790|P4|Participant Flow|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
293282|NCT00127790|P3|Participant Flow|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293283|NCT00127790|P2|Participant Flow|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293284|NCT00127790|P1|Participant Flow|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
293285|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
293286|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293287|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293288|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
293289|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
300769|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
293290|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293291|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293292|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
293293|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
293294|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293295|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293296|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
293297|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
293298|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293299|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293300|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
293301|NCT00127790|E4|Reported Event|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
293302|NCT00127790|E3|Reported Event|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293303|NCT00127790|E2|Reported Event|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
293304|NCT00127790|E1|Reported Event|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
293305|NCT00127803|B5|Baseline|Total|Total of all reporting groups
293306|NCT00127803|B4|Baseline|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
293843|NCT00128206|O2|Outcome|Rifampin|rifampin (600 mg orally) given daily for 4 months
293307|NCT00127803|B3|Baseline|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
293308|NCT00127803|B2|Baseline|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
293309|NCT00127803|B1|Baseline|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
293310|NCT00127803|P4|Participant Flow|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
293311|NCT00127803|P3|Participant Flow|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
293312|NCT00127803|P2|Participant Flow|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
293313|NCT00127803|P1|Participant Flow|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
293314|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
293315|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
293316|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
293317|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
293318|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
293319|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
293320|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
300770|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
293321|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
293322|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
293323|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
293324|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
293325|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
293326|NCT00127803|E4|Reported Event|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
293327|NCT00127803|E3|Reported Event|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
293328|NCT00127803|E2|Reported Event|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
293329|NCT00127803|E1|Reported Event|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
293330|NCT00127842|B1|Baseline|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293331|NCT00127842|P1|Participant Flow|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293332|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293333|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293334|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293335|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293336|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293337|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293338|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293339|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293340|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293341|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293342|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293343|NCT00127842|E1|Reported Event|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
293344|NCT00127855|B6|Baseline|Total|Total of all reporting groups
293345|NCT00127855|B5|Baseline|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293346|NCT00127855|B4|Baseline|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293347|NCT00127855|B3|Baseline|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293348|NCT00127855|B2|Baseline|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293349|NCT00127855|B1|Baseline|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293350|NCT00127855|P5|Participant Flow|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293351|NCT00127855|P4|Participant Flow|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293352|NCT00127855|P3|Participant Flow|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293353|NCT00127855|P2|Participant Flow|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293354|NCT00127855|P1|Participant Flow|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293591|NCT00128193|B3|Baseline|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293355|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293356|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293357|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293358|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293359|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293360|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293361|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293362|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293363|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293364|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293365|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293366|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293367|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293368|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293369|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293370|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293371|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293372|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293373|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293374|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293375|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
296665|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
293376|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293377|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293378|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293379|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293380|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293381|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293382|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293383|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293384|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293385|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293386|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293387|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293388|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293389|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293390|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293844|NCT00128206|O1|Outcome|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
293391|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293392|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293393|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293394|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293395|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293396|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293397|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293398|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293399|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293400|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293401|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293402|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293403|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293404|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293405|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293406|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293407|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293408|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293409|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293410|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293411|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293845|NCT00128206|E2|Reported Event|Rifampin|rifampin (600 mg orally) given daily for 4 months
293412|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293413|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293414|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293415|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293416|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293543|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1
HER2-neu negative: capecitabine + docetaxel
Duration: Four 3-week treatment cycles"
293417|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293418|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293419|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293420|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293421|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293422|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293423|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293424|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293425|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293426|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293427|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293428|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293429|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293430|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293431|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293432|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
328474|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
293433|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293434|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293435|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293436|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293437|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293438|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293439|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293440|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293441|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293442|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293443|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293444|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293445|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293446|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293447|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293448|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293449|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293450|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293451|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293452|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293453|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
328475|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
293454|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293455|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293456|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293457|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293458|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293459|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293460|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293461|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293462|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293463|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293464|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293465|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293466|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293467|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293468|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293469|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293470|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293471|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293472|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293473|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293474|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
328476|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
293475|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293476|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293477|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293478|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293479|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293480|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293481|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293482|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293483|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293484|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293485|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293486|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293487|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293488|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293489|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293490|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293491|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293492|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293493|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293494|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293495|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
294823|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
293496|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293497|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293498|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293499|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293500|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293501|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293502|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293503|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293504|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293505|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293506|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293507|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293508|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293509|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293510|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293511|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293512|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293513|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293514|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293515|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293516|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
294824|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
293517|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293518|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293519|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293520|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293521|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293522|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293523|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293524|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293525|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293526|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293527|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293528|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293529|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293530|NCT00127855|E5|Reported Event|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293531|NCT00127855|E4|Reported Event|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293532|NCT00127855|E3|Reported Event|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293533|NCT00127855|E2|Reported Event|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293534|NCT00127855|E1|Reported Event|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
293535|NCT00127933|B3|Baseline|Total|Total of all reporting groups
293536|NCT00127933|B2|Baseline|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly
HER2-neu positive: capecitabine + docetaxel + trastuzumab
Duration: Four 3-week treatment cycles"
293537|NCT00127933|B1|Baseline|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1
HER2-neu negative: capecitabine + docetaxel
Duration: Four 3-week treatment cycles"
293582|NCT00128193|B12|Baseline|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293846|NCT00128206|E1|Reported Event|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
293538|NCT00127933|P2|Participant Flow|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly
HER2-neu positive: capecitabine + docetaxel + trastuzumab
Duration: Four 3-week treatment cycles"
293539|NCT00127933|P1|Participant Flow|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1
HER2-neu negative: capecitabine + docetaxel
Duration: Four 3-week treatment cycles"
293540|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly
HER2-neu positive: capecitabine + docetaxel + trastuzumab
Duration: Four 3-week treatment cycles"
293541|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1
HER2-neu negative: capecitabine + docetaxel
Duration: Four 3-week treatment cycles"
293542|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly
HER2-neu positive: capecitabine + docetaxel + trastuzumab
Duration: Four 3-week treatment cycles"
293544|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly
HER2-neu positive: capecitabine + docetaxel + trastuzumab
Duration: Four 3-week treatment cycles"
293545|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1
HER2-neu negative: capecitabine + docetaxel
Duration: Four 3-week treatment cycles"
293546|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly
HER2-neu positive: capecitabine + docetaxel + trastuzumab
Duration: Four 3-week treatment cycles"
293547|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1
HER2-neu negative: capecitabine + docetaxel
Duration: Four 3-week treatment cycles"
293548|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly
HER2-neu positive: capecitabine + docetaxel + trastuzumab
Duration: Four 3-week treatment cycles"
293549|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1
HER2-neu negative: capecitabine + docetaxel
Duration: Four 3-week treatment cycles"
293550|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly
HER2-neu positive: capecitabine + docetaxel + trastuzumab
Duration: Four 3-week treatment cycles"
293551|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1
HER2-neu negative: capecitabine + docetaxel
Duration: Four 3-week treatment cycles"
293552|NCT00127933|E2|Reported Event|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly
HER2-neu positive: capecitabine + docetaxel + trastuzumab
Duration: Four 3-week treatment cycles"
293553|NCT00127933|E1|Reported Event|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):
Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1
HER2-neu negative: capecitabine + docetaxel
Duration: Four 3-week treatment cycles"
293554|NCT00128180|B3|Baseline|Total|Total of all reporting groups
293555|NCT00128180|B2|Baseline|Placebo|Placebo group
293556|NCT00128180|B1|Baseline|Active|Active drug
293557|NCT00128180|P2|Participant Flow|Placebo|Placebo group
293558|NCT00128180|P1|Participant Flow|Active|Active drug
293559|NCT00128180|O2|Outcome|Placebo|Placebo group
293560|NCT00128180|O1|Outcome|Active|Active drug
293561|NCT00128180|O2|Outcome|Placebo|Placebo group
293562|NCT00128180|O1|Outcome|Active|Active drug
293563|NCT00128180|O2|Outcome|Placebo|Placebo group
293564|NCT00128180|O1|Outcome|Active|Active drug
293565|NCT00128180|O2|Outcome|Placebo|Placebo group
293566|NCT00128180|O1|Outcome|Active|Active drug
293567|NCT00128180|O2|Outcome|Placebo|Placebo group
293568|NCT00128180|O1|Outcome|Active|Active drug
293569|NCT00128180|O2|Outcome|Placebo|Placebo group
293570|NCT00128180|O1|Outcome|Active|Active drug
293571|NCT00128180|O2|Outcome|Placebo|Placebo group
293572|NCT00128180|O1|Outcome|Active|Active drug
293573|NCT00128180|O2|Outcome|Placebo|Placebo group
293574|NCT00128180|O1|Outcome|Active|Active drug
293575|NCT00128180|O2|Outcome|Placebo|Placebo group
293576|NCT00128180|O1|Outcome|Active|Active drug
293577|NCT00128180|O2|Outcome|Placebo|Placebo group
293578|NCT00128180|O1|Outcome|Active|Active drug
293579|NCT00128180|E2|Reported Event|Placebo|Placebo group
293580|NCT00128180|E1|Reported Event|Active|Active drug
293581|NCT00128193|B13|Baseline|Total|Total of all reporting groups
293583|NCT00128193|B11|Baseline|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293584|NCT00128193|B10|Baseline|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293585|NCT00128193|B9|Baseline|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
293586|NCT00128193|B8|Baseline|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293587|NCT00128193|B7|Baseline|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293588|NCT00128193|B6|Baseline|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293589|NCT00128193|B5|Baseline|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293590|NCT00128193|B4|Baseline|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293686|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293592|NCT00128193|B2|Baseline|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293593|NCT00128193|B1|Baseline|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
293594|NCT00128193|P12|Participant Flow|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293595|NCT00128193|P11|Participant Flow|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293596|NCT00128193|P10|Participant Flow|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293597|NCT00128193|P9|Participant Flow|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
293598|NCT00128193|P8|Participant Flow|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293599|NCT00128193|P7|Participant Flow|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293600|NCT00128193|P6|Participant Flow|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293601|NCT00128193|P5|Participant Flow|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293602|NCT00128193|P4|Participant Flow|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293603|NCT00128193|P3|Participant Flow|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293604|NCT00128193|P2|Participant Flow|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293605|NCT00128193|P1|Participant Flow|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
293606|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293607|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293608|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293609|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293610|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293611|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293612|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293613|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293847|NCT00128219|B3|Baseline|Total|Total of all reporting groups
293614|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293615|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293616|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293617|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293618|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293619|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293620|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293621|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293622|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
300771|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
293623|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293624|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293625|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293626|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293627|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293628|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293629|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293630|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293631|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293632|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293633|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293634|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293635|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293636|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293637|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293638|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293639|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293640|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293641|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293642|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293643|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293644|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293645|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293646|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
328477|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
293647|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293648|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293649|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293650|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293651|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293652|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293653|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293654|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293856|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293655|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293656|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293657|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
293658|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293659|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293660|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293661|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293662|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293663|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293664|NCT00128193|O4|Outcome|C1 - High Dose in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293665|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293666|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293667|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293668|NCT00128193|O12|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293669|NCT00128193|O11|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293670|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293671|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
293672|NCT00128193|O8|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293673|NCT00128193|O7|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293674|NCT00128193|O6|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293675|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293676|NCT00128193|O4|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293677|NCT00128193|O3|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293678|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293839|NCT00128206|B2|Baseline|Rifampin|rifampin (600 mg orally) given daily for 4 months
293679|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
293680|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293681|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
293682|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293683|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293684|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293685|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
300772|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
293687|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293688|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293689|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293690|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293691|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293692|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293693|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293694|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293695|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293696|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293697|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293698|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293699|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293700|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293701|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293702|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293703|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293704|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293705|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293706|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293707|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293708|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293709|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
293840|NCT00128206|B1|Baseline|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
293710|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
293711|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293712|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293713|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293714|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293715|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293716|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293717|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
294084|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
293718|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293719|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293720|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
293721|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293722|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293723|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293724|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293725|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293726|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293727|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293728|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
293729|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293730|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293731|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293732|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293733|NCT00128193|O3|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293734|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293735|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293736|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293737|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293738|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293739|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293740|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293741|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293841|NCT00128206|P2|Participant Flow|Rifampin|rifampin (600 mg orally) given daily for 4 months
328478|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
293742|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293743|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293744|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293745|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293746|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293747|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293748|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293749|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293750|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293751|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293752|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293753|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293754|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293755|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293756|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293757|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293758|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293759|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293760|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293761|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293762|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293763|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293764|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293765|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293766|NCT00128193|O4|Outcome|C1 - High Dose in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293767|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
293768|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293769|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293770|NCT00128193|O12|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293771|NCT00128193|O11|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293772|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293773|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
293774|NCT00128193|O8|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293842|NCT00128206|P1|Participant Flow|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
293775|NCT00128193|O7|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293776|NCT00128193|O6|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293777|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293778|NCT00128193|O4|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293779|NCT00128193|O3|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293780|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293781|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
300773|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
293782|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293783|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293784|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293785|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293786|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293787|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293788|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293789|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293790|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293791|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293792|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293793|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293794|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293795|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293796|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
293797|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293798|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293799|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293800|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293801|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
293802|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293803|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293804|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293805|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293806|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293807|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293808|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293809|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293810|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293811|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293812|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293813|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
294778|NCT00138203|P1|Participant Flow|SAHA|Suberoylanilide Hydroxamic Acid (SAHA), 400mg orally, once daily, in a 21 day cycle.
293814|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
293815|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293816|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293817|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293818|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
293819|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293820|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293821|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293822|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293823|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
293824|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293825|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
293826|NCT00128193|E12|Reported Event|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293827|NCT00128193|E11|Reported Event|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293828|NCT00128193|E10|Reported Event|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
293829|NCT00128193|E9|Reported Event|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
293830|NCT00128193|E8|Reported Event|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293831|NCT00128193|E7|Reported Event|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293832|NCT00128193|E6|Reported Event|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293833|NCT00128193|E5|Reported Event|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
293834|NCT00128193|E4|Reported Event|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293835|NCT00128193|E3|Reported Event|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293836|NCT00128193|E2|Reported Event|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
293837|NCT00128193|E1|Reported Event|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
293838|NCT00128206|B3|Baseline|Total|Total of all reporting groups
293848|NCT00128219|B2|Baseline|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293849|NCT00128219|B1|Baseline|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293850|NCT00128219|P2|Participant Flow|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293851|NCT00128219|P1|Participant Flow|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293852|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293853|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293854|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293855|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293857|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293858|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293859|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293860|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293861|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293862|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293863|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293864|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293865|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293866|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293867|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293868|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293869|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293870|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293871|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293872|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293873|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293874|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293875|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293876|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293877|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293878|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293879|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293880|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293881|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293882|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293883|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293884|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293885|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293886|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293887|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293888|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293889|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293890|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293891|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293892|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
294779|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
293893|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293894|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293895|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293896|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293897|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293898|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293899|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293900|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293901|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293902|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293903|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293904|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293905|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293906|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293907|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293908|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293909|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293910|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293911|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293912|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293913|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293914|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293915|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293916|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293917|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293918|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293919|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
328479|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
293920|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293921|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293922|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293923|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293924|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293925|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293926|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293927|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293928|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
293929|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
293930|NCT00128219|E2|Reported Event|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine). The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.
293931|NCT00128219|E1|Reported Event|GBS III-TT Vaccine|The experimental arm received a single dose of GBS III-TT vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.
293932|NCT00128401|B3|Baseline|Total|Total of all reporting groups
293933|NCT00128401|B2|Baseline|Placebo|
293934|NCT00128401|B1|Baseline|D-cycloserine|
293935|NCT00128401|P2|Participant Flow|Placebo|"Subjects were randomized to receive cognitive behavioral therapy with augmentation of placebo administered on day of therapy session.
All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent."
293936|NCT00128401|P1|Participant Flow|D-cycloserine|Subjects were randomized to receive cognitive behavioral therapy with augmentation of D-cycloserine 50 mg administered on day of therapy session. All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent.
293937|NCT00128401|O2|Outcome|Placebo|
293938|NCT00128401|O1|Outcome|D-cycloserine|
293939|NCT00128401|O2|Outcome|Placebo|
293940|NCT00128401|O1|Outcome|D-cycloserine|
293941|NCT00128401|E3|Reported Event|Not Assigned|
293942|NCT00128401|E2|Reported Event|Placebo|
293943|NCT00128401|E1|Reported Event|D-cycloserine|
293944|NCT00128492|B3|Baseline|Total|Total of all reporting groups
293945|NCT00128492|B2|Baseline|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293946|NCT00128492|B1|Baseline|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293947|NCT00128492|P2|Participant Flow|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293948|NCT00128492|P1|Participant Flow|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293949|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293950|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293951|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293952|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293953|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293954|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293955|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293956|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293957|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293958|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293959|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293960|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293961|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293962|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293963|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293964|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293965|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293966|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293967|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293968|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293969|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293970|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293971|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293972|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293973|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293974|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293975|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293976|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293977|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
294034|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
293978|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293979|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293980|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293981|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293982|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293983|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293984|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293985|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293986|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293987|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293988|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293989|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293990|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293991|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293992|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293993|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293994|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293995|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293996|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293997|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
293998|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
293999|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
294000|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
294001|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
294035|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294002|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
294003|NCT00128492|E2|Reported Event|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
TID = three times daily"
294004|NCT00128492|E1|Reported Event|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.
BID = twice daily"
294005|NCT00128661|B3|Baseline|Total|Total of all reporting groups
294006|NCT00128661|B2|Baseline|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294007|NCT00128661|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294008|NCT00128661|P2|Participant Flow|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294780|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
294009|NCT00128661|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294010|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294011|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294012|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294013|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294014|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294015|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294016|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294017|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294018|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294019|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294020|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294021|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294022|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294023|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294024|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294025|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294026|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294027|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294028|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294029|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294030|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294031|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294032|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294033|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294036|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294037|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294038|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294039|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294040|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294041|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294042|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294043|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294044|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294045|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294046|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294047|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294048|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294049|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294050|NCT00128661|E2|Reported Event|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294051|NCT00128661|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
294052|NCT00128713|B4|Baseline|Total|Total of all reporting groups
294053|NCT00128713|B3|Baseline|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294054|NCT00128713|B2|Baseline|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294055|NCT00128713|B1|Baseline|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294056|NCT00128713|P3|Participant Flow|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294057|NCT00128713|P2|Participant Flow|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294058|NCT00128713|P1|Participant Flow|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294059|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294060|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294061|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294062|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294063|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294064|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294065|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294066|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294067|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294068|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294069|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294070|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294071|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294072|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294073|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294074|NCT00128713|E3|Reported Event|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294075|NCT00128713|E2|Reported Event|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294076|NCT00128713|E1|Reported Event|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
294077|NCT00128830|B1|Baseline|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
294078|NCT00128830|P1|Participant Flow|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
294079|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
294080|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
294081|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
294082|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
294083|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
294781|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
294085|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
294086|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
294087|NCT00128830|O2|Outcome|Viral Load Less Than 50 Copies/mL|Viral load less than 50 copies/mL at TMC125-C229 Baseline
294088|NCT00128830|O1|Outcome|Viral Load More Than or Equal to 50 Copies/mL|Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
294089|NCT00128830|O2|Outcome|Viral Load Less Than 50 Copies/mL|Viral load less than 50 copies/mL at TMC125-C229 Baseline
294090|NCT00128830|O1|Outcome|Viral Load More Than or Equal to 50 Copies/mL|Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
294091|NCT00128830|E1|Reported Event|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
294092|NCT00128921|B4|Baseline|Total|Total of all reporting groups
294093|NCT00128921|B3|Baseline|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
294094|NCT00128921|B2|Baseline|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
294095|NCT00128921|B1|Baseline|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
294096|NCT00128921|P3|Participant Flow|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
294097|NCT00128921|P2|Participant Flow|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
294098|NCT00128921|P1|Participant Flow|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
294099|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
294100|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
294101|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
294102|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
294103|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
294104|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
294105|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11).
294106|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
294107|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
294108|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
294109|NCT00128921|O2|Outcome|Cohort B|Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
294110|NCT00128921|O1|Outcome|Cohort A|Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
294111|NCT00128921|E3|Reported Event|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
294112|NCT00128921|E2|Reported Event|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
294113|NCT00128921|E1|Reported Event|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
294114|NCT00129116|B6|Baseline|Total|Total of all reporting groups
294115|NCT00129116|B5|Baseline|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294116|NCT00129116|B4|Baseline|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294117|NCT00129116|B3|Baseline|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294672|NCT00137449|B2|Baseline|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
328480|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
294118|NCT00129116|B2|Baseline|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294119|NCT00129116|B1|Baseline|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294120|NCT00129116|P5|Participant Flow|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294121|NCT00129116|P4|Participant Flow|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294122|NCT00129116|P3|Participant Flow|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294123|NCT00129116|P2|Participant Flow|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294124|NCT00129116|P1|Participant Flow|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294125|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294126|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294127|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294128|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294129|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294130|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294726|NCT00137631|E2|Reported Event|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
294131|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294132|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294133|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
300774|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
294134|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294135|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294136|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294137|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294138|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294139|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294140|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294141|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294142|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294143|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294727|NCT00137631|E1|Reported Event|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
294728|NCT00137969|B3|Baseline|Total|Total of all reporting groups
294144|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294145|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294146|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294147|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294148|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294149|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294150|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294151|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294152|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294153|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294154|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294155|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294156|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294825|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294826|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294157|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294158|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294159|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294160|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294161|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294162|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294163|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294164|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294165|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294166|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294167|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294168|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294169|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294827|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294828|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294170|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294171|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294172|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294173|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294174|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294175|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294176|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294177|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294178|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294179|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294180|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294181|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294182|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294829|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294830|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294183|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294184|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294185|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294186|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294187|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294188|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294189|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294190|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294191|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294192|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294193|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294194|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294195|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294831|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294832|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294196|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294197|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294198|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294199|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294200|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294201|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294202|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294203|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294204|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294205|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294206|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294207|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294208|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294833|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294834|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294209|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294210|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294211|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294212|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294213|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294214|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294215|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294216|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294217|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294218|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294219|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294220|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294221|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294835|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294836|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294222|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294223|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294224|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294225|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294226|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294227|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294228|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294229|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294230|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294231|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294232|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294233|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294234|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294837|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294838|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294235|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294236|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294237|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294238|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294239|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294240|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294241|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294242|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294243|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294244|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294245|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294246|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294247|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294839|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294840|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294248|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294249|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294250|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294251|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294252|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294253|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294254|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294255|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294256|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294257|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294258|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294259|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294260|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294841|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294842|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294261|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294262|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294263|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294264|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294265|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294266|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294267|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294268|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294269|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294270|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294271|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294272|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294273|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294843|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294844|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294274|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294275|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294276|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294277|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294278|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294279|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294280|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294281|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294282|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294283|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294284|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294285|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294286|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294845|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294846|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294287|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294288|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294289|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294290|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294291|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294292|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294293|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294294|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294295|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294296|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294297|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294298|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294299|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294847|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294848|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294300|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294301|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294302|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294303|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294304|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294305|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294306|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294307|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294308|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294309|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294310|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294311|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294312|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294849|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294850|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294313|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294314|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294315|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294316|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294317|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294318|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294319|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294320|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294321|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294322|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294323|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294324|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294325|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294851|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294852|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294326|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294327|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294328|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294329|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294330|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294331|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294332|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294333|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294334|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294335|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294336|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294337|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294338|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294853|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294854|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294339|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294340|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294341|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294342|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294343|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294344|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294345|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294346|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294347|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294348|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294349|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294350|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294351|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294855|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294856|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294352|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294353|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294354|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294355|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294356|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294357|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294358|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294359|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294360|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294361|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294362|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294363|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294364|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294857|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294858|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294365|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294366|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294367|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294368|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294369|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294370|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294371|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294372|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294373|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294374|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294375|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294376|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294377|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294859|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294860|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294378|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294379|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294380|NCT00129116|E5|Reported Event|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294381|NCT00129116|E4|Reported Event|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294382|NCT00129116|E3|Reported Event|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294383|NCT00129116|E2|Reported Event|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294384|NCT00129116|E1|Reported Event|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
294385|NCT00129129|B4|Baseline|Total|Total of all reporting groups
294386|NCT00129129|B3|Baseline|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294387|NCT00129129|B2|Baseline|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294388|NCT00129129|B1|Baseline|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh..
294389|NCT00129129|P5|Participant Flow|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294390|NCT00129129|P4|Participant Flow|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
294391|NCT00129129|P3|Participant Flow|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294861|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294862|NCT00138424|E4|Reported Event|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294392|NCT00129129|P2|Participant Flow|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294393|NCT00129129|P1|Participant Flow|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294394|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294395|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294396|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294397|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294398|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294399|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294400|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294401|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294402|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294863|NCT00138424|E3|Reported Event|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294403|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294404|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294415|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294782|NCT00138203|E1|Reported Event|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
300775|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
294405|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294406|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294407|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294408|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294409|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294410|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294411|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294412|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294413|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294437|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294775|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
294414|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
300776|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
294416|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294417|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294418|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
294419|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294420|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294421|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294422|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294423|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294424|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294425|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294426|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294427|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294428|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294429|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294430|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294431|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294432|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294433|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294434|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294435|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294436|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294504|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
328481|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
294438|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294439|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294440|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294441|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294442|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294443|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294444|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294445|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294446|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294447|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294448|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294673|NCT00137449|B1|Baseline|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294449|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294450|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294451|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294452|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294453|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294454|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294455|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294456|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294457|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294458|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294459|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294674|NCT00137449|P2|Participant Flow|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294460|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294461|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294507|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
296750|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
294462|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294463|NCT00129129|O3|Outcome|ActHIB/Menhibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294464|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294465|NCT00129129|O1|Outcome|Menhibrix Group|Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh.
294466|NCT00129129|O3|Outcome|ActHIB/Menhibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294467|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294468|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294469|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
294470|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294471|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294815|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294816|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294472|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294473|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294474|NCT00129129|O1|Outcome|Menhibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294475|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294476|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294477|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294478|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294479|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294480|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294481|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294482|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294505|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294483|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294904|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294484|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294485|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294486|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294487|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
294488|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294489|NCT00129129|O1|Outcome|Menhibrix Group|Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh.
294490|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294491|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294492|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294493|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294494|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294817|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294818|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294495|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294496|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294497|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294498|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294499|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294500|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294501|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294502|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294503|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294506|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294508|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294509|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294510|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294511|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294512|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294513|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294514|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294638|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
294515|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294783|NCT00138294|B1|Baseline|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
294516|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294517|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294518|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294519|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294520|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294521|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294522|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294523|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294524|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294905|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294525|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294526|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294527|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294528|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294529|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294530|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294531|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294532|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294819|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294542|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294533|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294534|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294535|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294536|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294537|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294538|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294539|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294540|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294541|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294543|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294544|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294545|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294546|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294547|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294548|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294549|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294550|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294669|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294670|NCT00137436|E1|Reported Event|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294563|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294551|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294552|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294553|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294554|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294555|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294556|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294557|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294558|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294559|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294560|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294561|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294562|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294564|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294565|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294566|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294567|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294568|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294569|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294570|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294571|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294572|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294584|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294671|NCT00137449|B3|Baseline|Total|Total of all reporting groups
294639|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
295849|NCT00141518|O4|Outcome|Total|All participants
296751|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
294573|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294574|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294575|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294576|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294577|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294578|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294579|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294580|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294581|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294582|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294583|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294695|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294585|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294586|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294587|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294588|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294589|NCT00129129|E5|Reported Event|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294590|NCT00129129|E4|Reported Event|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
294591|NCT00129129|E3|Reported Event|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
294592|NCT00129129|E2|Reported Event|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
294593|NCT00129129|E1|Reported Event|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
294594|NCT00134901|B3|Baseline|Total|Total of all reporting groups
294595|NCT00134901|B2|Baseline|Placebo|Placebo daily dose
294596|NCT00134901|B1|Baseline|Memantine|Memantine 40mg/day
294597|NCT00134901|P2|Participant Flow|Placebo|Placebo daily dose
294598|NCT00134901|P1|Participant Flow|Memantine|Memantine 40mg/day
294599|NCT00134901|O2|Outcome|Placebo|"Placebo
placebo: placebo"
294600|NCT00134901|O1|Outcome|Memantine|"Memantine
Memantine: Memantine"
294601|NCT00134901|O2|Outcome|Placebo|Placebo daily dose
294602|NCT00134901|O1|Outcome|Memantine|Memantine 40mg/day
294603|NCT00134901|E2|Reported Event|Placebo|Placebo daily dose
294604|NCT00134901|E1|Reported Event|Memantine|Memantine 40mg/day
294605|NCT00137267|B3|Baseline|Total|Total of all reporting groups
294636|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
294606|NCT00137267|B2|Baseline|Arm 2 - Health Education|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.
Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
294607|NCT00137267|B1|Baseline|Arm 1 - Time Limited Case Management (TLC)|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.
Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
294608|NCT00137267|P2|Participant Flow|Health Education|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.
Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group."
294609|NCT00137267|P1|Participant Flow|Time Limited Case Management|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.
Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
294610|NCT00137267|O2|Outcome|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.
Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
294611|NCT00137267|O1|Outcome|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.
Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
294612|NCT00137267|O2|Outcome|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.
Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
294613|NCT00137267|O1|Outcome|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.
Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
294637|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
328482|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
294614|NCT00137267|E2|Reported Event|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.
Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
294615|NCT00137267|E1|Reported Event|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.
Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
294616|NCT00137280|B3|Baseline|Total|Total of all reporting groups
294617|NCT00137280|B2|Baseline|Usual Care|Continue with usual care
294618|NCT00137280|B1|Baseline|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
294619|NCT00137280|P2|Participant Flow|Usual Care|Continue with usual care
294620|NCT00137280|P1|Participant Flow|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
294621|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
294622|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
294623|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
294624|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
294625|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
294626|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
294627|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
294628|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
294629|NCT00137280|E2|Reported Event|Usual Care|Continue with usual care
294630|NCT00137280|E1|Reported Event|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
294631|NCT00137423|B3|Baseline|Total|Total of all reporting groups
294632|NCT00137423|B2|Baseline|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
294633|NCT00137423|B1|Baseline|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
294634|NCT00137423|P2|Participant Flow|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
294635|NCT00137423|P1|Participant Flow|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
294724|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
294640|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
294641|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294642|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294643|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294644|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294645|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294646|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294647|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294648|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294649|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294650|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294651|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294652|NCT00137423|E2|Reported Event|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294653|NCT00137423|E1|Reported Event|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
294654|NCT00137436|B1|Baseline|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294655|NCT00137436|P1|Participant Flow|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|Sunitinib 37.5 milligrams (mg) plus (+) Docetaxel 75 mg per meters squared (mg/m^2) + Prednisone 5 mg given twice daily
294656|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294657|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294658|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294659|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294660|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294661|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294662|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294663|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294664|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294665|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294666|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294667|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
294668|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
328483|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
294675|NCT00137449|P1|Participant Flow|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294894|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294676|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294677|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294678|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294679|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294680|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294681|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294682|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294683|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294684|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294685|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294686|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294687|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294688|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294689|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294690|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294691|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294692|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294693|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294694|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294725|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
294696|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294697|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294698|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294699|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294700|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294701|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294702|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294703|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294704|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294705|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294706|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294707|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294708|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294709|NCT00137449|E2|Reported Event|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294710|NCT00137449|E1|Reported Event|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
294711|NCT00137631|B3|Baseline|Total|Total of all reporting groups
294712|NCT00137631|B2|Baseline|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
294713|NCT00137631|B1|Baseline|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
294714|NCT00137631|P2|Participant Flow|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
294715|NCT00137631|P1|Participant Flow|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
294716|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
294717|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
294718|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
294719|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
294720|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
294721|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
294722|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
294723|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
328484|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
294776|NCT00138151|E1|Reported Event|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
294729|NCT00137969|B2|Baseline|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294730|NCT00137969|B1|Baseline|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294731|NCT00137969|P2|Participant Flow|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294732|NCT00137969|P1|Participant Flow|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294733|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294734|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294735|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294736|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294737|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294738|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294739|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294740|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294741|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294742|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294743|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294744|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294745|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294820|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294821|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294746|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294747|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294748|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294749|NCT00137969|E2|Reported Event|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294750|NCT00137969|E1|Reported Event|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
294751|NCT00138034|B3|Baseline|Total|Total of all reporting groups
294752|NCT00138034|B2|Baseline|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
294753|NCT00138034|B1|Baseline|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
294754|NCT00138034|P2|Participant Flow|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
294755|NCT00138034|P1|Participant Flow|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
294756|NCT00138034|O2|Outcome|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
294757|NCT00138034|O1|Outcome|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
294758|NCT00138034|O2|Outcome|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
294759|NCT00138034|O1|Outcome|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
294760|NCT00138034|E2|Reported Event|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
294761|NCT00138034|E1|Reported Event|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
294762|NCT00138073|B1|Baseline|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.
Web-based waveform interpretation guide: Use of an educational website."
294763|NCT00138073|P1|Participant Flow|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.
Web-based waveform interpretation guide: Use of an educational website."
294764|NCT00138073|O1|Outcome|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.
Web-based waveform interpretation guide: Use of an educational website."
294765|NCT00138073|O1|Outcome|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.
Web-based waveform interpretation guide: Use of an educational website."
294766|NCT00138073|E1|Reported Event|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.
Web-based waveform interpretation guide: Use of an educational website."
294767|NCT00138125|B1|Baseline|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.
Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
294768|NCT00138125|P1|Participant Flow|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.
Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
294769|NCT00138125|O1|Outcome|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.
Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
294770|NCT00138125|E1|Reported Event|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.
Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
294771|NCT00138151|B1|Baseline|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
294772|NCT00138151|P1|Participant Flow|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
294773|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
294774|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
294822|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
328485|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
294784|NCT00138294|P1|Participant Flow|Intervention Cities|Eligible children 4 years of age and older whose parents provided consent (assent for children>7 years) in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
294785|NCT00138294|O1|Outcome|Influenza Vaccine|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Serious adverse events (SAEs) and MAARI adverse events within 42 days post-LAIV vaccination were captured in seasonal and pandemic LAIV vaccinated study subjects in the intervention area.
294786|NCT00138294|O2|Outcome|Comparison Cities|Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
294787|NCT00138294|O1|Outcome|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
294788|NCT00138294|O2|Outcome|Comparison Cities|Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
294789|NCT00138294|O1|Outcome|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
294790|NCT00138294|O2|Outcome|Comparison Cities|Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
294791|NCT00138294|O1|Outcome|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
294792|NCT00138294|E1|Reported Event|All Enrolled Study Participants|Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites will received their influenza vaccines (live attenuated or inactivated influenza vaccines) by the local healthcare providers
294793|NCT00138424|B5|Baseline|Total|Total of all reporting groups
294794|NCT00138424|B4|Baseline|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294795|NCT00138424|B3|Baseline|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294796|NCT00138424|B2|Baseline|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294797|NCT00138424|B1|Baseline|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294798|NCT00138424|P4|Participant Flow|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294799|NCT00138424|P3|Participant Flow|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294800|NCT00138424|P2|Participant Flow|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294801|NCT00138424|P1|Participant Flow|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294802|NCT00138424|O2|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week - days 0, 7, 21, 35, 49)
294803|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week - days 0, 7, 21, 35, 49)
294804|NCT00138424|O2|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week - days 0, 7, 21, 35, 49)
294805|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week - days 0, 7, 21, 35, 49)
294806|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294807|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294808|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294809|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294810|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294811|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294812|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294813|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294814|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
294864|NCT00138424|E2|Reported Event|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294865|NCT00138424|E1|Reported Event|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
294866|NCT00138645|B3|Baseline|Total|Total of all reporting groups
294867|NCT00138645|B2|Baseline|Healthy Diet|Healthy Diet
294868|NCT00138645|B1|Baseline|MicroDiet|MicroDiet
294869|NCT00138645|P2|Participant Flow|Healthy Diet|Healthy Diet
294870|NCT00138645|P1|Participant Flow|MicroDiet|MicroDiet
294871|NCT00138645|O2|Outcome|Healthy Diet|Healthy Diet
294872|NCT00138645|O1|Outcome|MicroDiet|MicroDiet
294873|NCT00138645|E2|Reported Event|Healthy Diet|participants randomized to the low-calorie diet.
294874|NCT00138645|E1|Reported Event|MicroDiet|Participants randomized to the MicroDiet
294895|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294896|NCT00138671|O2|Outcome|Subcutaneous Insulin|
294875|NCT00138658|B1|Baseline|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
294876|NCT00138658|P1|Participant Flow|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
294877|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
294878|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
294879|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
294880|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
294881|NCT00138658|O1|Outcome|Mean Reduction in Serum Clusterin From Baseline|The mean reduction in serum clusterin was calculated by determining the difference from baseline to the minimum post baseline level. The reduction in serum clusterin was determined for all subjects who had baseline and at least one post-baseline serum clusterin assessment (n=55).
294882|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
294883|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
294884|NCT00138658|E1|Reported Event|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
294885|NCT00138671|B3|Baseline|Total|Total of all reporting groups
294886|NCT00138671|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294887|NCT00138671|B1|Baseline|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295895|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
294888|NCT00138671|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294889|NCT00138671|P1|Participant Flow|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294890|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294891|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294892|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294893|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294897|NCT00138671|O1|Outcome|Inhaled Insulin|
294906|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294907|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294908|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294909|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294910|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294911|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294912|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294913|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294914|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294915|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294916|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294917|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294918|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294919|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294920|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294921|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294922|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294923|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294924|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294925|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294926|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294927|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294928|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294929|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294930|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294931|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294932|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294933|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294934|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294935|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294936|NCT00138671|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294937|NCT00138671|E1|Reported Event|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294938|NCT00139477|B3|Baseline|Total|Total of all reporting groups
294939|NCT00139477|B2|Baseline|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
294940|NCT00139477|B1|Baseline|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
294941|NCT00139477|P2|Participant Flow|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
294942|NCT00139477|P1|Participant Flow|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
294943|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294944|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294945|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294946|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294947|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294948|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294949|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294950|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294951|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294952|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294953|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294954|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294955|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294956|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294957|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294958|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
294959|NCT00139477|E2|Reported Event|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
294960|NCT00139477|E1|Reported Event|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
294961|NCT00139659|B3|Baseline|Total|Total of all reporting groups
294962|NCT00139659|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294963|NCT00139659|B1|Baseline|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294964|NCT00139659|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294965|NCT00139659|P1|Participant Flow|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294966|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294967|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294968|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294969|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294970|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294971|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294972|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294973|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294974|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294975|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294976|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294977|NCT00139659|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294978|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294979|NCT00139659|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294980|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294981|NCT00139659|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294982|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294983|NCT00139659|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294984|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294985|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294986|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294987|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294988|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294989|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294990|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294991|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294992|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294993|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294994|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294995|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294996|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294997|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
294998|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
294999|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295000|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295001|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295002|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295003|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295004|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295005|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295006|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295007|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295008|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295009|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295010|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295011|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295012|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295013|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295014|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295015|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295016|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295017|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295018|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295019|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295020|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295021|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295022|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295023|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295024|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295025|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295026|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295027|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295028|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295029|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295030|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295031|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295032|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295033|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295034|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295035|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295036|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295037|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295038|NCT00139659|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
295039|NCT00139659|E1|Reported Event|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
295040|NCT00132002|B1|Baseline|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
295041|NCT00132002|P1|Participant Flow|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
295042|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
295043|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
295044|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
295045|NCT00132002|E1|Reported Event|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
295046|NCT00132028|B1|Baseline|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
295047|NCT00132028|P1|Participant Flow|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
295048|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
295049|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
295050|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
295051|NCT00132028|E1|Reported Event|SAHA (Vorinostat)|
295052|NCT00132132|B3|Baseline|Total|Total of all reporting groups
295053|NCT00132132|B2|Baseline|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
295054|NCT00132132|B1|Baseline|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
295137|NCT00140842|O2|Outcome|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
295055|NCT00132132|P2|Participant Flow|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
295056|NCT00132132|P1|Participant Flow|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
295057|NCT00132132|O2|Outcome|Standard of Care/Control Group|The Standard of Care/Control group received visits to primary care provider and referral to nutritionist
295058|NCT00132132|O1|Outcome|Intervention Group|The intervention group attended monthly, 4 hour sessions for one year
295059|NCT00132132|O2|Outcome|Standard of Care/Control Group|The Standard of Care/Control group received visits to primary care provider and referral to nutritionist
295060|NCT00132132|O1|Outcome|Intervention Group|The intervention group attended monthly, 4 hour sessions for one year
295061|NCT00132132|E2|Reported Event|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
295062|NCT00132132|E1|Reported Event|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
295927|NCT00141778|E1|Reported Event|Placebo|Placebo Group
295063|NCT00139737|B1|Baseline|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
295064|NCT00139737|P1|Participant Flow|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
295065|NCT00139737|O1|Outcome|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
295066|NCT00139737|E1|Reported Event|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
295067|NCT00139776|B3|Baseline|Total|Total of all reporting groups
295068|NCT00139776|B2|Baseline|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295069|NCT00139776|B1|Baseline|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295070|NCT00139776|P4|Participant Flow|Celecoxib 200mg Intermittent Use|Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295071|NCT00139776|P3|Participant Flow|Celecoxib 200mg Continuous Use|Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295072|NCT00139776|P2|Participant Flow|Open-Label Celecoxib Run-in Period|Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study).
295073|NCT00139776|P1|Participant Flow|Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories|Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare.
295074|NCT00139776|O1|Outcome|Celecoxib 200mg Open Label|Period II run-in (2 weeks). Celecoxib 200 mg daily until resolution of screening osteoarthritis flare as defined by IVRS
295075|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295076|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295077|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295078|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295079|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295080|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295081|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295082|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295083|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295084|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295085|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295086|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295087|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295088|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295089|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295090|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295091|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295092|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295093|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295094|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295095|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295096|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295097|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295098|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295099|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295100|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295101|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295102|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295103|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295104|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295105|NCT00139776|E2|Reported Event|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
295106|NCT00139776|E1|Reported Event|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
295107|NCT00139997|B3|Baseline|Total|Total of all reporting groups
295108|NCT00139997|B2|Baseline|Inactive Intervention|Equivalent exposure to inactive negative ion generator
295109|NCT00139997|B1|Baseline|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
295110|NCT00139997|P2|Participant Flow|Inactive Intervention|Equivalent exposure to inactive negative ion generator
295111|NCT00139997|P1|Participant Flow|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
295112|NCT00139997|O2|Outcome|Inactive Intervention|Equivalent exposure to inactive negative ion generator
295113|NCT00139997|O1|Outcome|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
295114|NCT00139997|O2|Outcome|Inactive Intervention|Equivalent exposure to inactive negative ion generator
295115|NCT00139997|O1|Outcome|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
295116|NCT00139997|E2|Reported Event|Inactive Intervention|Equivalent exposure to inactive negative ion generator
295117|NCT00139997|E1|Reported Event|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
295118|NCT00140556|B1|Baseline|Entire Study Population|
295119|NCT00140556|P1|Participant Flow|Entire Study Population|
295120|NCT00140556|O1|Outcome|Entire Study Population|
295121|NCT00140556|E1|Reported Event|Entire Study Population|
295122|NCT00140621|B1|Baseline|Agalsidase Beta|Agalsidase beta 1 mg/kg intravenously once every 2 weeks up to 156 weeks.
295123|NCT00140621|P1|Participant Flow|Agalsidase Beta (Fabrazyme [Recombinant Form])|Agalsidase beta 1 milligram per kilogram (mg/kg) intravenously once every 2 weeks up to 156 weeks.
295124|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
295125|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
295126|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
295127|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
295128|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
295129|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
295130|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
295131|NCT00140621|E1|Reported Event|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
295132|NCT00140842|B3|Baseline|Total|Total of all reporting groups
295133|NCT00140842|B2|Baseline|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
295134|NCT00140842|B1|Baseline|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
295135|NCT00140842|P2|Participant Flow|Obese Girls|Obese adolescents between 12–18 years old.
295136|NCT00140842|P1|Participant Flow|Normal-weight Girls|Normal weight girls 12-18 years old
295138|NCT00140842|O1|Outcome|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
295139|NCT00140842|O2|Outcome|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
295140|NCT00140842|O1|Outcome|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
295141|NCT00140842|E2|Reported Event|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
295142|NCT00140842|E1|Reported Event|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
295143|NCT00141037|B3|Baseline|Total|Total of all reporting groups
295144|NCT00141037|B2|Baseline|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
295145|NCT00141037|B1|Baseline|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
295146|NCT00141037|P2|Participant Flow|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
295147|NCT00141037|P1|Participant Flow|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
295148|NCT00141037|O2|Outcome|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
295149|NCT00141037|O1|Outcome|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
295150|NCT00141037|O2|Outcome|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
295151|NCT00141037|O1|Outcome|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
295152|NCT00141037|E2|Reported Event|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
295199|NCT00141219|P1|Participant Flow|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295200|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295272|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295153|NCT00141037|E1|Reported Event|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
295154|NCT00141102|B3|Baseline|Total|Total of all reporting groups
295155|NCT00141102|B2|Baseline|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
295156|NCT00141102|B1|Baseline|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295157|NCT00141102|P2|Participant Flow|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295158|NCT00141102|P1|Participant Flow|Celecoxib|200 milligrams (mg) twice daily (BID) plus omeprazole placebo and diclofenac slow release (SR) placebo
295159|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295160|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295161|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295162|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295928|NCT00141817|B5|Baseline|Total|Total of all reporting groups
295163|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295164|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295165|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295166|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295167|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
295168|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295169|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295170|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295171|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
295172|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295173|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295174|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295175|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295176|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295177|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295178|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295179|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
295180|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295181|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295182|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295183|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295184|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295185|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295186|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295187|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295188|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295189|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295190|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295191|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295192|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295193|NCT00141102|E2|Reported Event|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
295194|NCT00141102|E1|Reported Event|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
295195|NCT00141219|B3|Baseline|Total|Total of all reporting groups
295196|NCT00141219|B2|Baseline|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295197|NCT00141219|B1|Baseline|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295198|NCT00141219|P2|Participant Flow|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295201|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295202|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295203|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295204|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295205|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295206|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295207|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295208|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295929|NCT00141817|B4|Baseline|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
295209|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295210|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295211|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295212|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295213|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295214|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295215|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295216|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295217|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295218|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295219|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295220|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295221|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295222|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295223|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295224|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295225|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295226|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295227|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295228|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295229|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295230|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295271|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295231|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295232|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295233|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295234|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295235|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295236|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295237|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295238|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295239|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295240|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295241|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295242|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295243|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295244|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295245|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295246|NCT00141219|E2|Reported Event|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
295247|NCT00141219|E1|Reported Event|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
295248|NCT00141271|B4|Baseline|Total|Total of all reporting groups
295249|NCT00141271|B3|Baseline|Placebo|Subjects were assigned to placebo
295250|NCT00141271|B2|Baseline|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295251|NCT00141271|B1|Baseline|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295252|NCT00141271|P3|Participant Flow|Placebo|Subjects were assigned to placebo
295253|NCT00141271|P2|Participant Flow|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295254|NCT00141271|P1|Participant Flow|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295255|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295256|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295257|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295258|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295259|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295260|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295261|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295262|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295263|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295264|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295265|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295266|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295267|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295268|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295269|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295270|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295274|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295275|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295276|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295277|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295278|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295279|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295280|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295281|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295282|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295283|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295284|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295285|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295286|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295287|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295288|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295289|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295290|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295291|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295292|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295293|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295294|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295295|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295296|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295297|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295298|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295299|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295300|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295301|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295302|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295303|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295304|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295305|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295306|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295307|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295308|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295309|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295310|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295311|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295312|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295313|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295314|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295315|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295316|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295317|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295318|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295319|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295320|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295321|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295322|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295323|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295324|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295325|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295326|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295327|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295328|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295329|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295330|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295331|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295332|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295333|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295334|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295335|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295336|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295337|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295338|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295339|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295340|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295341|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295342|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295343|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295344|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295345|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295346|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295347|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295348|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295349|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295350|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295351|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295352|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295353|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295354|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295355|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295356|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295357|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295358|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295359|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295360|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295361|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295362|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295363|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295364|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295365|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295366|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
295367|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295368|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295369|NCT00141271|E3|Reported Event|Placebo|Subjects were assigned to placebo
295370|NCT00141271|E2|Reported Event|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
295371|NCT00141271|E1|Reported Event|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
295372|NCT00141297|B3|Baseline|Total|Total of all reporting groups
295373|NCT00141297|B2|Baseline|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
328486|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
295374|NCT00141297|B1|Baseline|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295375|NCT00141297|P10|Participant Flow|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295376|NCT00141297|P9|Participant Flow|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295377|NCT00141297|P8|Participant Flow|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295378|NCT00141297|P7|Participant Flow|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295930|NCT00141817|B3|Baseline|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
295931|NCT00141817|B2|Baseline|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
295379|NCT00141297|P6|Participant Flow|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295380|NCT00141297|P5|Participant Flow|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295381|NCT00141297|P4|Participant Flow|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295382|NCT00141297|P3|Participant Flow|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295383|NCT00141297|P2|Participant Flow|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295384|NCT00141297|P1|Participant Flow|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295385|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295386|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295387|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295388|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295389|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295390|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295391|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295392|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295393|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295394|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295395|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295396|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295883|NCT00141765|O1|Outcome|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue
Stem Cell Rescue: autologous stem cell transplantation"
295397|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295398|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295399|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295400|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295401|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295932|NCT00141817|B1|Baseline|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
295402|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295403|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295404|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295405|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295406|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295407|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295408|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295409|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295410|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295411|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295412|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295413|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295414|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295415|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295416|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295417|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295418|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295419|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295420|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295896|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
295421|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295422|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295423|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295424|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295425|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295426|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295427|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295428|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295429|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295430|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295431|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295432|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295433|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295434|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295435|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295436|NCT00141297|O2|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295437|NCT00141297|O1|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295438|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295439|NCT00141297|O2|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295440|NCT00141297|O1|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295441|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295442|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295884|NCT00141765|E1|Reported Event|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue
Stem Cell Rescue: autologous stem cell transplantation"
295443|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295444|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295445|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295446|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295933|NCT00141817|P4|Participant Flow|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
295934|NCT00141817|P3|Participant Flow|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
295447|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295448|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295449|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295450|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295451|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295452|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295453|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295454|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295455|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295456|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295457|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295458|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295459|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295460|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295461|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295462|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295463|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295464|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295465|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295466|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295467|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295468|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295935|NCT00141817|P2|Participant Flow|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
295469|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295470|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295471|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295472|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295473|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295474|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295475|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295476|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295477|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295478|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295479|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295480|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295481|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295482|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295483|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295484|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295485|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295486|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295487|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295488|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295489|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295490|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
296752|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
295491|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295492|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295493|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295494|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295495|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295496|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295497|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295498|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295499|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295500|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295501|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295502|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295503|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295504|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295505|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295506|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295507|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295508|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295509|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295510|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295511|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295512|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295513|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295514|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295515|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295516|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295517|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295518|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295519|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295520|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295521|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295522|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295523|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295524|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295525|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295526|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295527|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295528|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295529|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295530|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295531|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295532|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295885|NCT00141778|B4|Baseline|Total|Total of all reporting groups
295533|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295534|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295535|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295536|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295537|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295538|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295539|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295540|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295541|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295542|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295543|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295544|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295545|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295546|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295547|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295548|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295549|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295550|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295551|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295552|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295553|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295554|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295886|NCT00141778|B3|Baseline|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295897|NCT00141778|O1|Outcome|Placebo|Placebo Group
295555|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295556|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295557|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295558|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295559|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295560|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295561|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295562|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295563|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295564|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295565|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295566|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295567|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295568|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295569|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295570|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295571|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295572|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295573|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295574|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295575|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295576|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295887|NCT00141778|B2|Baseline|Ramipril|Angiotensin-converting enzyme inhibitor group
295577|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295578|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295936|NCT00141817|P1|Participant Flow|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
296753|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
295579|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295580|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295581|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295582|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295583|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295584|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295585|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295586|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295587|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295588|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295589|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295590|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295591|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295592|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295593|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295594|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295595|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295596|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295597|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295598|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295599|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295888|NCT00141778|B1|Baseline|Placebo|Placebo Group
295600|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295601|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295937|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
295602|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295603|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295604|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295605|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295606|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295607|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295608|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295609|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295610|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295611|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295612|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295613|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295614|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295615|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295616|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295617|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295618|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295619|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295620|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295621|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295622|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295623|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
328487|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
295624|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295625|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295626|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295627|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295628|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295629|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295630|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295631|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295632|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295633|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295634|NCT00141297|O2|Outcome|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295635|NCT00141297|O1|Outcome|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295636|NCT00141297|O2|Outcome|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295637|NCT00141297|O1|Outcome|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295638|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295639|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295640|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295641|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295642|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295643|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295644|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295645|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295646|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295898|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295647|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295648|NCT00141297|E10|Reported Event|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295649|NCT00141297|E9|Reported Event|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295650|NCT00141297|E8|Reported Event|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295651|NCT00141297|E7|Reported Event|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295652|NCT00141297|E6|Reported Event|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295653|NCT00141297|E5|Reported Event|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295654|NCT00141297|E4|Reported Event|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295655|NCT00141297|E3|Reported Event|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295656|NCT00141297|E2|Reported Event|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295657|NCT00141297|E1|Reported Event|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
295658|NCT00141453|B3|Baseline|Total|Total of all reporting groups
295659|NCT00141453|B2|Baseline|Placebo Comparator|Matching placebo tablets
295660|NCT00141453|B1|Baseline|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
295661|NCT00141453|P2|Participant Flow|Placebo Comparator|Matching placebo tablets
295662|NCT00141453|P1|Participant Flow|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
295663|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
295664|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
295665|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
295666|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
295667|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
295668|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
295669|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
295670|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
295671|NCT00141453|E2|Reported Event|Placebo Comparator|Matching placebo tablets
295672|NCT00141453|E1|Reported Event|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
295673|NCT00141518|B4|Baseline|Total|Total of all reporting groups
295674|NCT00141518|B3|Baseline|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295675|NCT00141518|B2|Baseline|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295676|NCT00141518|B1|Baseline|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295677|NCT00141518|P3|Participant Flow|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295889|NCT00141778|P3|Participant Flow|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist Group.Spironolactone was given as 25 mg/day.
295678|NCT00141518|P2|Participant Flow|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
296754|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
295679|NCT00141518|P1|Participant Flow|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295680|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295681|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295682|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295683|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295684|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295685|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295686|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295687|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295688|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295689|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295690|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295691|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295899|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
295900|NCT00141778|O1|Outcome|Placebo|Placebo Group
295692|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295693|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295694|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295695|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295696|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295697|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295698|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295699|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295700|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295701|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295702|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295703|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295704|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295705|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295901|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295902|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
295706|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295707|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295708|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295709|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295710|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295711|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295712|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295713|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295714|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295715|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295716|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295717|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295718|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295719|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295903|NCT00141778|O1|Outcome|Placebo|Placebo Group
295904|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295720|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295721|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295722|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295723|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295724|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295725|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295726|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295727|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295728|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295729|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295730|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295731|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295732|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295733|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295905|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
295906|NCT00141778|O1|Outcome|Placebo|Placebo Group
295734|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295735|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295736|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295737|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295738|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295739|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295740|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295741|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295742|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295743|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295744|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295745|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295746|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295747|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295907|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295908|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
295748|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295749|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295750|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295751|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295752|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295753|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295754|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295755|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295756|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295757|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295758|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295759|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295760|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295761|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295909|NCT00141778|O1|Outcome|Placebo|Placebo Group
295910|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295762|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295763|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295764|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295765|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295766|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295767|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295768|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295769|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295770|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295771|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295772|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295773|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295774|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295775|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295911|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
295912|NCT00141778|O1|Outcome|Placebo|Placebo Group
295776|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295777|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295778|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295779|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295780|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295781|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295782|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295783|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295784|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295785|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295786|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295787|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295788|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295789|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295913|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295914|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
295790|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295791|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295792|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295793|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295794|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295795|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295796|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295797|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295798|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295799|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295800|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295801|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295802|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295803|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295915|NCT00141778|O1|Outcome|Placebo|Placebo Group
295916|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295804|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295805|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295806|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295807|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295808|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295809|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295810|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295811|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295812|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295813|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295814|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295815|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295816|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295817|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295917|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
295918|NCT00141778|O1|Outcome|Placebo|Placebo Group
295818|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295819|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295820|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295821|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295822|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295823|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295824|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295825|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295826|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295827|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295828|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295829|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295830|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295831|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295919|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295920|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
295832|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295833|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295834|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295835|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295836|NCT00141518|O1|Outcome|Total|Duodopa-naïve participants, Duodopa non-naïve participants treated with Duodopa for < 2 years, and Duodopa non-naïve participants treated with Duodopa for ≥ 2 years received Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295837|NCT00141518|O4|Outcome|Total|All participants
295838|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295839|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295840|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295841|NCT00141518|O4|Outcome|Total|All participants
295842|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295843|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295844|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295845|NCT00141518|O4|Outcome|Total|All participants
295846|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295847|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295890|NCT00141778|P2|Participant Flow|Ramipril|Angiotensin-Converting Enzyme Inhibitor Group. Ramipril was given as 2.5 mg the first 3 days followed by 5 mg/day, with the dose reduced to 2.5 mg/day on the first postoperative day only.
295891|NCT00141778|P1|Participant Flow|Placebo|Placebo Group
295892|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295848|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295850|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295851|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295852|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295853|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295854|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295855|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295856|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295857|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295858|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295859|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295860|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295861|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295862|NCT00141518|E3|Reported Event|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295893|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
295863|NCT00141518|E2|Reported Event|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
296755|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
295864|NCT00141518|E1|Reported Event|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
295865|NCT00141726|B1|Baseline|Etanercept Treatment|"Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
295866|NCT00141726|P1|Participant Flow|Etanercept Treatment|"Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
295867|NCT00141726|O1|Outcome|Etanercept Treatment|"Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
295868|NCT00141726|O1|Outcome|Etanercept Treatment|"Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
295869|NCT00141726|E1|Reported Event|Etanercept Treatment|"Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
295870|NCT00141739|B1|Baseline|GVHD Prophylaxis|"GVHD prophylaxis with etanercept
Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
295871|NCT00141739|P1|Participant Flow|GVHD Prophylaxis|"GVHD prophylaxis with etanercept
Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
295872|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept
Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
295873|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.
Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
295874|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept
Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
295875|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.
Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
295876|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept
Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
295877|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.
Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
295878|NCT00141739|O1|Outcome|GVHD Prophylaxis|"GVHD prophylaxis with etanercept
Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
295879|NCT00141739|O1|Outcome|GVHD Prophylaxis|"GVHD prophylaxis with etanercept
Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
295880|NCT00141739|E1|Reported Event|GVHD Prophylaxis|"GVHD prophylaxis with etanercept
Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
295881|NCT00141765|B1|Baseline|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue
Stem Cell Rescue: autologous stem cell transplantation"
295882|NCT00141765|P1|Participant Flow|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue
Stem Cell Rescue: autologous stem cell transplantation"
295894|NCT00141778|O1|Outcome|Placebo|Placebo Group
295922|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295923|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
295924|NCT00141778|O1|Outcome|Placebo|Placebo Group
295925|NCT00141778|E3|Reported Event|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
295926|NCT00141778|E2|Reported Event|Ramipril|Angiotensin-converting enzyme inhibitor group
295938|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
295939|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
295940|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
295941|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
295942|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
295943|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
295944|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
295945|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
295946|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
295947|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
295948|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
295949|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
295950|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
295951|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
295952|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
295953|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
295954|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
295955|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
295956|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
295957|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
295958|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
295959|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
295960|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
295961|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
295962|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
295963|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
295964|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
295965|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
295966|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
295967|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
295968|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
295969|NCT00141817|E4|Reported Event|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
295970|NCT00141817|E3|Reported Event|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
295971|NCT00141817|E2|Reported Event|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
295972|NCT00141817|E1|Reported Event|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
295973|NCT00141921|B1|Baseline|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295974|NCT00141921|P1|Participant Flow|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295975|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295976|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295977|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295978|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295979|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295980|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295981|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295982|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295983|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295984|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
296756|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
295985|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295986|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295987|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295988|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295989|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295990|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295991|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295992|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295993|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295994|NCT00141921|E1|Reported Event|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
295995|NCT00142116|B1|Baseline|All WM Patients|Waldenstrom's Macroglobulinemia Patients
295996|NCT00142116|P1|Participant Flow|All WM Patients|Waldenstrom's Macroglobulinemia Patients
295997|NCT00142116|O1|Outcome|Thalidomide and Rituximab|"Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks
Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
Thalidomide: 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.
Rituximab: Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later."
295998|NCT00142116|O1|Outcome|All WM Patients|Waldenstrom's Macroglobulinemia Patients
295999|NCT00142116|E1|Reported Event|All WM Patients|Waldenstrom's Macroglobulinemia Patients
296000|NCT00142168|B1|Baseline|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
296001|NCT00142168|P1|Participant Flow|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
296002|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
296003|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
296004|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
296005|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
296006|NCT00142168|E1|Reported Event|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
296007|NCT00142298|B11|Baseline|Total|Total of all reporting groups
296008|NCT00142298|B10|Baseline|Group C: Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296188|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296732|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296009|NCT00142298|B9|Baseline|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296010|NCT00142298|B8|Baseline|Group C: LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296011|NCT00142298|B7|Baseline|Group B: LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296012|NCT00142298|B6|Baseline|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
296013|NCT00142298|B5|Baseline|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296014|NCT00142298|B4|Baseline|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296015|NCT00142298|B3|Baseline|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296016|NCT00142298|B2|Baseline|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296017|NCT00142298|B1|Baseline|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
296018|NCT00142298|P10|Participant Flow|Group C: Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296019|NCT00142298|P9|Participant Flow|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296020|NCT00142298|P8|Participant Flow|Group C: LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296021|NCT00142298|P7|Participant Flow|Group B: LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296022|NCT00142298|P6|Participant Flow|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
296023|NCT00142298|P5|Participant Flow|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296024|NCT00142298|P4|Participant Flow|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296025|NCT00142298|P3|Participant Flow|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296026|NCT00142298|P2|Participant Flow|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296027|NCT00142298|P1|Participant Flow|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
296092|NCT00142597|O2|Outcome|Sham Treatment|"Sham acupuncture is used.
Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.
All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
296028|NCT00142298|O1|Outcome|Group C : Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296029|NCT00142298|O2|Outcome|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296030|NCT00142298|O1|Outcome|Group C : LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296031|NCT00142298|O1|Outcome|Group B : LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296100|NCT00142818|B1|Baseline|ModNal|"Nal + Mod
Naltrexone: 150 mg daily for males; 100 mg daily for females
Modafinil: 400 mg daily"
296101|NCT00142818|P4|Participant Flow|Double Placebo|"Placebo
Placebo: 400 mg and/or 100-150 mg placebo pills"
296032|NCT00142298|O1|Outcome|Group B : LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
296033|NCT00142298|O3|Outcome|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296034|NCT00142298|O2|Outcome|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296035|NCT00142298|O1|Outcome|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296036|NCT00142298|O1|Outcome|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296037|NCT00142298|O1|Outcome|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
296038|NCT00142298|E10|Reported Event|Group C : Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296039|NCT00142298|E9|Reported Event|Group C: Lam Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296040|NCT00142298|E8|Reported Event|Group C : LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
296041|NCT00142298|E7|Reported Event|Group B: Lam 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296042|NCT00142298|E6|Reported Event|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
296043|NCT00142298|E5|Reported Event|Group A: Feeder 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296044|NCT00142298|E4|Reported Event|Group A: Feeder 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296045|NCT00142298|E3|Reported Event|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296046|NCT00142298|E2|Reported Event|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
296047|NCT00142298|E1|Reported Event|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
296049|NCT00142415|B6|Baseline|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
296050|NCT00142415|B5|Baseline|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
296051|NCT00142415|B4|Baseline|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
296052|NCT00142415|B3|Baseline|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
296053|NCT00142415|B2|Baseline|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
296054|NCT00142415|B1|Baseline|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
296055|NCT00142415|P6|Participant Flow|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
296056|NCT00142415|P5|Participant Flow|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
296057|NCT00142415|P4|Participant Flow|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
296058|NCT00142415|P3|Participant Flow|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
296059|NCT00142415|P2|Participant Flow|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
296060|NCT00142415|P1|Participant Flow|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
296061|NCT00142415|O6|Outcome|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
296062|NCT00142415|O5|Outcome|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
296063|NCT00142415|O4|Outcome|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
296064|NCT00142415|O3|Outcome|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
296065|NCT00142415|O2|Outcome|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
296066|NCT00142415|O1|Outcome|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
296067|NCT00142415|O1|Outcome|Dosimetry Evaluable Analysis Set|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 to 70 mCi/m^2 of 177-Lu."
296068|NCT00142415|O6|Outcome|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
296069|NCT00142415|O5|Outcome|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
296185|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296070|NCT00142415|O4|Outcome|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
296071|NCT00142415|O3|Outcome|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
296072|NCT00142415|O2|Outcome|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
296073|NCT00142415|O1|Outcome|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
296074|NCT00142415|O6|Outcome|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
296075|NCT00142415|O5|Outcome|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
296076|NCT00142415|O4|Outcome|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
296077|NCT00142415|O3|Outcome|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
296078|NCT00142415|O2|Outcome|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
296079|NCT00142415|O1|Outcome|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
296080|NCT00142415|E7|Reported Event|Total|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 to 70 mCi/m^2 of 177-Lu."
296081|NCT00142415|E6|Reported Event|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
296082|NCT00142415|E5|Reported Event|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
296083|NCT00142415|E4|Reported Event|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
296084|NCT00142415|E3|Reported Event|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
296085|NCT00142415|E2|Reported Event|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
296086|NCT00142415|E1|Reported Event|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
296087|NCT00142597|B3|Baseline|Total|Total of all reporting groups
296088|NCT00142597|B2|Baseline|Sham Treatment|"Sham acupuncture is used.
Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.
All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
296089|NCT00142597|B1|Baseline|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.
Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.
Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.
All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
296090|NCT00142597|P2|Participant Flow|Sham Treatment|"Sham acupuncture is used.
Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.
All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
296091|NCT00142597|P1|Participant Flow|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.
Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.
Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.
All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
296093|NCT00142597|O1|Outcome|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.
Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.
Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.
All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
296094|NCT00142597|E2|Reported Event|Sham Treatment|"Sham acupuncture is used.
Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.
All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
296095|NCT00142597|E1|Reported Event|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.
Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.
Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.
All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
296096|NCT00142818|B5|Baseline|Total|Total of all reporting groups
296097|NCT00142818|B4|Baseline|Double Placebo|"Placebo
Placebo: 400 mg and/or 100-150 mg placebo pills"
296098|NCT00142818|B3|Baseline|Modafinil and Placebo|"Mod
Modafinil: 400 mg daily"
296099|NCT00142818|B2|Baseline|Naltrexone and Placebo|"Nal
Naltrexone: 150 mg daily for males; 100 mg daily for females"
296102|NCT00142818|P3|Participant Flow|Modafinil and Placebo|"Mod
Modafinil: 400 mg daily"
296103|NCT00142818|P2|Participant Flow|Naltrexone and Placebo|"Nal
Naltrexone: 150 mg daily for males; 100 mg daily for females"
296104|NCT00142818|P1|Participant Flow|ModNal|"Nal + Mod
Naltrexone: 150 mg daily for males; 100 mg daily for females
Modafinil: 400 mg daily"
296105|NCT00142818|O4|Outcome|Double Placebo|"Placebo
Placebo: 400 mg and/or 100-150 mg placebo pills"
296106|NCT00142818|O3|Outcome|Modafinil and Placebo|"Mod
Modafinil: 400 mg daily"
296107|NCT00142818|O2|Outcome|Naltrexone and Placebo|"Nal
Naltrexone: 150 mg daily for males; 100 mg daily for females"
296108|NCT00142818|O1|Outcome|ModNal|"Nal + Mod
Naltrexone: 150 mg daily for males; 100 mg daily for females
Modafinil: 400 mg daily"
296109|NCT00142818|E4|Reported Event|Double Placebo|"Placebo
Placebo: 400 mg and/or 100-150 mg placebo pills"
296110|NCT00142818|E3|Reported Event|Modafinil and Placebo|"Mod
Modafinil: 400 mg daily"
296111|NCT00142818|E2|Reported Event|Naltrexone and Placebo|"Nal
Naltrexone: 150 mg daily for males; 100 mg daily for females"
296112|NCT00142818|E1|Reported Event|ModNal|"Nal + Mod
Naltrexone: 150 mg daily for males; 100 mg daily for females
Modafinil: 400 mg daily"
296113|NCT00142909|B3|Baseline|Total|Total of all reporting groups
296114|NCT00142909|B2|Baseline|Placebo|
296115|NCT00142909|B1|Baseline|Lofexidine|
296116|NCT00142909|P2|Participant Flow|Placebo|Participants will receive daily placebo and follow the same schedule as the active intervention for 12 weeks.
296117|NCT00142909|P1|Participant Flow|Lofexidine|"Lofexidine: Study medication
Participants will receive daily lofexidine and the dosing will be initiated at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject."
296118|NCT00142909|O2|Outcome|Placebo|Placebo pill
296119|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
296120|NCT00142909|O2|Outcome|Placebo|Placebo pill
296121|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
296122|NCT00142909|O2|Outcome|Placebo|Placebo pill
296123|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
296124|NCT00142909|O2|Outcome|Placebo|Placebo pill
296125|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
296126|NCT00142909|O2|Outcome|Placebo|Placebo pill
296127|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
296128|NCT00142909|O2|Outcome|Placebo|Placebo pill
296129|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
296130|NCT00142909|E2|Reported Event|Placebo|Placebo pill
296131|NCT00142909|E1|Reported Event|Lofexidine|Lofexidine: Study medication
296132|NCT00142935|B4|Baseline|Total|Total of all reporting groups
296133|NCT00142935|B3|Baseline|MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
296134|NCT00142935|B2|Baseline|MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
296135|NCT00142935|B1|Baseline|Pre-release MMT Initiation + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
296136|NCT00142935|P3|Participant Flow|MMT Referral Post Release|Participants assigned to this arm will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with Medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.
296137|NCT00142935|P2|Participant Flow|MMT Referral Post Release + Payment|Participants assigned to this arm will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
296186|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296187|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296138|NCT00142935|P1|Participant Flow|Pre-release MMT Initiation + Referral Post Release + Payment|Participants assigned to this arm will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
296139|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
296140|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
296141|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
296142|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
296201|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296143|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
296144|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
296145|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
296146|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
296147|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
296148|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
296149|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
296150|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
296151|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
296152|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
296153|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
296154|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
296155|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
296156|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
296157|NCT00142935|E3|Reported Event|As Assigned: MMT Referral Post Release|"Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
Fatal overdose deaths are calculated using all participants assigned to Arm 3. Other adverse events are calculated using self reported data from 12 month interviews."
296158|NCT00142935|E2|Reported Event|As Assigned: MMT Referral Post Release + Payment|"Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
Fatal overdose deaths are calculated using all participants assigned to Arm 2. Other adverse events are calculated using self reported data from 12 month interviews."
296159|NCT00142935|E1|Reported Event|As Assigned: Pre-release MMT + Referral Post Release + Payment|"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
Fatal overdose deaths are calculated using all participants assigned to Arm 1. Other adverse events are calculated using self reported data from 12 month interviews."
296189|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296160|NCT00135200|B1|Baseline|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
296161|NCT00135200|P1|Participant Flow|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
296202|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296757|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296162|NCT00135200|O1|Outcome|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
296163|NCT00135200|O1|Outcome|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
296164|NCT00135200|E1|Reported Event|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
296165|NCT00135330|B4|Baseline|Total|Total of all reporting groups
296166|NCT00135330|B3|Baseline|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296167|NCT00135330|B2|Baseline|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296168|NCT00135330|B1|Baseline|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296169|NCT00135330|P3|Participant Flow|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296170|NCT00135330|P2|Participant Flow|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296171|NCT00135330|P1|Participant Flow|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296172|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296173|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296174|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296175|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296176|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296177|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296178|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296179|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296180|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296181|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296182|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296183|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296184|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296190|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296191|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296192|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296193|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296194|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296195|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296196|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296197|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296198|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296199|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296200|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296203|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296204|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296205|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296206|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296207|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296208|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296209|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296210|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296211|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296212|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296213|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296214|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296215|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296216|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296217|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296218|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296219|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296220|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296221|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296222|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296223|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296224|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296225|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296226|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296227|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296228|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296229|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296230|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296231|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296232|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296233|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296234|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296235|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296655|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296236|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296237|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296238|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296239|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296240|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296241|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296242|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296243|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296244|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296245|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296246|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296247|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296248|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296249|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296250|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296251|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296252|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296253|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296254|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296255|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296256|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296257|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296258|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296259|NCT00135330|E3|Reported Event|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
296260|NCT00135330|E2|Reported Event|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
296261|NCT00135330|E1|Reported Event|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
296262|NCT00135356|B3|Baseline|Total|Total of all reporting groups
296263|NCT00135356|B2|Baseline|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296264|NCT00135356|B1|Baseline|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296265|NCT00135356|P2|Participant Flow|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296266|NCT00135356|P1|Participant Flow|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296267|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296268|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296269|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296270|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296271|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296272|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296725|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296273|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296274|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296275|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296276|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296277|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296278|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296279|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296280|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296281|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296282|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296283|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296284|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296285|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296286|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296287|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296288|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296289|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296290|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296291|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296292|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296293|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296294|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296295|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296296|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296297|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296726|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296298|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296299|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296300|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296301|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
296302|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
296303|NCT00135356|E2|Reported Event|PI/RTV Control Arm|
296304|NCT00135356|E1|Reported Event|ATV/RTV Switch Arm|
296305|NCT00135694|B4|Baseline|Total|Total of all reporting groups
296343|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
296306|NCT00135694|B3|Baseline|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
296307|NCT00135694|B2|Baseline|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
296308|NCT00135694|B1|Baseline|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
296309|NCT00135694|P3|Participant Flow|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
296310|NCT00135694|P2|Participant Flow|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
296311|NCT00135694|P1|Participant Flow|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
296312|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
296313|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
296314|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
296315|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
296316|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
296317|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
296318|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
296319|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
296320|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
296321|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
296322|NCT00135694|O1|Outcome|All Enrolled|Subjects who underwent liver transplantation in the trial.
296323|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
296324|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
296325|NCT00135694|E3|Reported Event|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
296326|NCT00135694|E2|Reported Event|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
296327|NCT00135694|E1|Reported Event|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
296328|NCT00135798|B4|Baseline|Total|Total of all reporting groups
296329|NCT00135798|B3|Baseline|LADR Treatment: Genotypes 2 or 3|Patients in this subgroup were all assigned to LADR treatment.
296330|NCT00135798|B2|Baseline|LADR Treatment: Genotypes 1, 4, 6|Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
296331|NCT00135798|B1|Baseline|Standard Clinical Care: Genotypes 1, 4, 6|Subjects randomized to non-treatment group 1:2 compared to treatment group.
296332|NCT00135798|P3|Participant Flow|LADR Treatment: Genotypes 2 or 3|Patients in this subgroup were all assigned to LADR treatment.
296333|NCT00135798|P2|Participant Flow|LADR Treatment: Genotypes 1, 4, 6|Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
296334|NCT00135798|P1|Participant Flow|Standard Clinical Care: Genotypes 1, 4, 6|Subjects randomized to non-treatment group 1:2 compared to treatment group.
296335|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
296336|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
296337|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
296338|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
296339|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
296340|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
296341|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
296342|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
296344|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
296345|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
296346|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
296347|NCT00135798|E2|Reported Event|LADR Treatment (All Genotypes)|This group combines all who received LADR treatment (Per Protocol analysis) for all Genotypes 1,4,6 and 2,3
296348|NCT00135798|E1|Reported Event|Standard Clinical Care: Genotypes 1, 4, 6|Subjects who received no LADR treatment (Per Protocol analysis)
296349|NCT00136084|B3|Baseline|Total|Total of all reporting groups
296350|NCT00136084|B2|Baseline|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
296351|NCT00136084|B1|Baseline|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
296352|NCT00136084|P2|Participant Flow|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
296353|NCT00136084|P1|Participant Flow|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
296354|NCT00136084|O1|Outcome|Overall|17 of the 232 eligible patients
296355|NCT00136084|O2|Outcome|Arm 2:(LDAC)|Low-dose Cytarabine (Ara-C) (LDAC)
296356|NCT00136084|O1|Outcome|Arm 1: (HDAC)|High-dose Cytarabine (Ara-C) (HDAC)
296357|NCT00136084|O1|Outcome|Overall|Evaluation of all study participants
296358|NCT00136084|O1|Outcome|Overall|Post-GO Treatment MRD
296359|NCT00136084|O1|Outcome|Overall|Patients who have no response to one course of induction therapy
296360|NCT00136084|O1|Outcome|Overall|Post-GO Treatment MRD
296361|NCT00136084|O2|Outcome|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
296362|NCT00136084|O1|Outcome|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
296363|NCT00136084|E2|Reported Event|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
296364|NCT00136084|E1|Reported Event|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
296365|NCT00136318|B3|Baseline|Total|Total of all reporting groups
296366|NCT00136318|B2|Baseline|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
Peginterferon alfa-2a :
Placebo :
Ribavirin :"
296367|NCT00136318|B1|Baseline|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
Peginterferon alfa-2a :
Escitalopram :
Ribavirin :"
296368|NCT00136318|P2|Participant Flow|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
Peginterferon alfa-2a :
Placebo :
Ribavirin :"
296369|NCT00136318|P1|Participant Flow|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
Peginterferon alfa-2a :
Escitalopram :
Ribavirin :"
296370|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
Peginterferon alfa-2a :
Placebo :
Ribavirin :"
296371|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
Peginterferon alfa-2a :
Escitalopram :
Ribavirin :"
296372|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
Peginterferon alfa-2a :
Placebo :
Ribavirin :"
296373|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
Peginterferon alfa-2a :
Escitalopram :
Ribavirin :"
296374|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
Peginterferon alfa-2a :
Placebo :
Ribavirin :"
296727|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296375|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
Peginterferon alfa-2a :
Escitalopram :
Ribavirin :"
296376|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
Peginterferon alfa-2a :
Placebo :
Ribavirin :"
296377|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
Peginterferon alfa-2a :
Escitalopram :
Ribavirin :"
296378|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
Peginterferon alfa-2a :
Placebo :
Ribavirin :"
296379|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period, patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
Peginterferon alfa-2a :
Escitalopram :
Ribavirin :"
296380|NCT00136318|E2|Reported Event|Placebo|
296381|NCT00136318|E1|Reported Event|Escitalopram|
296382|NCT00136357|B3|Baseline|Total|Total of all reporting groups
297347|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
296383|NCT00136357|B2|Baseline|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
296384|NCT00136357|B1|Baseline|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
296385|NCT00136357|P2|Participant Flow|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
296386|NCT00136357|P1|Participant Flow|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
296387|NCT00136357|O2|Outcome|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
296388|NCT00136357|O1|Outcome|Mind-Body Skills Groups|"12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
Mind-Body Skills Groups: 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques."
296389|NCT00136357|E2|Reported Event|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
296390|NCT00136357|E1|Reported Event|Mind-Body Skills Groups|"12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
Mind-Body Skills Groups: 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques."
296391|NCT00136695|B3|Baseline|Total|Total of all reporting groups
296392|NCT00136695|B2|Baseline|Placebo|"placebo
anastrozole: 1 mg QD"
296393|NCT00136695|B1|Baseline|Anastrozole|"anastrozole
anastrozole: 1 mg QD"
296394|NCT00136695|P2|Participant Flow|Placebo|"placebo
anastrozole: 1 mg QD"
296395|NCT00136695|P1|Participant Flow|Anastrozole|"anastrozole
anastrozole: 1 mg QD"
296396|NCT00136695|O2|Outcome|Placebo|"placebo
anastrozole: 1 mg QD"
296397|NCT00136695|O1|Outcome|Anastrozole|"anastrozole
anastrozole: 1 mg QD"
296398|NCT00136695|E2|Reported Event|Placebo|"placebo
anastrozole: 1 mg QD"
296399|NCT00136695|E1|Reported Event|Anastrozole|"anastrozole
anastrozole: 1 mg QD"
296400|NCT00136760|B5|Baseline|Total|Total of all reporting groups
296401|NCT00136760|B4|Baseline|NR + PLA|Non-contingent reinforcement plus placebo
296402|NCT00136760|B3|Baseline|NR + BUP|Non-contingent reinforcement plus bupropion
296403|NCT00136760|B2|Baseline|CM + PLA|Contingent reinforcement plus placebo
296404|NCT00136760|B1|Baseline|CM + BUP|Contingent reinforcement plus bupropion
296405|NCT00136760|P4|Participant Flow|NR + PLA|Non-contingent reinforcement plus placebo
296406|NCT00136760|P3|Participant Flow|NR + BUP|Non-contingent reinforcement plus bupropion
296407|NCT00136760|P2|Participant Flow|CM + PLA|Contingent reinforcement plus placebo
296408|NCT00136760|P1|Participant Flow|CM + BUP|Contingent reinforcement plus bupropion
296409|NCT00136760|O4|Outcome|NR + PLA|Non-contingent reinforcement plus placebo
296410|NCT00136760|O3|Outcome|NR + BUP|Non-contingent reinforcement plus bupropion
296411|NCT00136760|O2|Outcome|CM + PLA|Contingent reinforcement plus placebo
296412|NCT00136760|O1|Outcome|CM + BUP|Contingent reinforcement plus bupropion
296413|NCT00136760|O4|Outcome|NR + PLA|Non-contingent reinforcement plus placebo
296414|NCT00136760|O3|Outcome|NR + BUP|Non-contingent reinforcement plus bupropion
296415|NCT00136760|O2|Outcome|CM + PLA|Contingent reinforcement plus placebo
296416|NCT00136760|O1|Outcome|CM + BUP|Contingent reinforcement plus bupropion
296417|NCT00136760|E4|Reported Event|NR + PLA|Non-contingent reinforcement plus placebo
296418|NCT00136760|E3|Reported Event|NR + BUP|Non-contingent reinforcement plus bupropion
296419|NCT00136760|E2|Reported Event|CM + PLA|Contingent reinforcement plus placebo
296420|NCT00136760|E1|Reported Event|CM + BUP|Contingent reinforcement plus bupropion
296421|NCT00136812|B3|Baseline|Total|Total of all reporting groups
296422|NCT00136812|B2|Baseline|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
296423|NCT00136812|B1|Baseline|Control|Usual care provided NRT during hospitalization with brief cessation advice.
296424|NCT00136812|P2|Participant Flow|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
296425|NCT00136812|P1|Participant Flow|Control|Usual care provided NRT during hospitalization with brief cessation advice.
296426|NCT00136812|O2|Outcome|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
296427|NCT00136812|O1|Outcome|Control|Usual care provided NRT during hospitalization with brief cessation advice.
296428|NCT00136812|E2|Reported Event|2: Intervention|"intervention
Tobacco Use Cessation: This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization. Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge."
296429|NCT00136812|E1|Reported Event|1: Enhanced Standard Care Control|enhanced standard care control
296457|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
300777|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
296430|NCT00136838|B1|Baseline|Study Participants|This is a within-group study design, all participant who completed the study completed 2 phases of treatment, done in random order, each lasting 5 days and separated by at least 2 weeks. During one of the phases participants were exposed to active cigarette cues (pack of cigarettes, smoke) and during the other phase they were exposed to sham control cues (water bottle and the glass)
296431|NCT00136838|P2|Participant Flow|Active Cue First, Then Neutral Cue|"Each participant receives two consecutive interventions in random order.
Cigarette cue: during this phase of treatment participants were presented with active cigarette cue
Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue"
296432|NCT00136838|P1|Participant Flow|Neutral Cue First, Then Active Cue|"Participants receives two consecutive interventions in random order.
Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
Cigarette cue: during this phase of treatment participants were presented with active cigarette cue"
296433|NCT00136838|O2|Outcome|Neutral Cue Craving|intensity of craving following cue exposure
296434|NCT00136838|O1|Outcome|Active Cue Craving|intensity of craving following cue exposure
296435|NCT00136838|O2|Outcome|Neutral Cue|During this phase of study participants were exposed to a neutral (sham) cue: a bottle of water and a glass
296436|NCT00136838|O1|Outcome|Active Cue|During this phase participants were exposed to active cigarette cues: pack of cigarettes and a cigarette smoke
296437|NCT00136838|E2|Reported Event|Active Cue|1.Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.
296438|NCT00136838|E1|Reported Event|Neutral Cue|Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
296439|NCT00136916|B3|Baseline|Total|Total of all reporting groups
296440|NCT00136916|B2|Baseline|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296441|NCT00136916|B1|Baseline|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296442|NCT00136916|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296443|NCT00136916|P1|Participant Flow|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296444|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296445|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296446|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296447|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296448|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296449|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296450|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296451|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296728|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296452|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296453|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296454|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296455|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296456|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
300778|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
296458|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296459|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296460|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296461|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296462|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296463|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296464|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296465|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296466|NCT00136916|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296467|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®) (mg)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296468|NCT00136916|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296469|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®) (mg)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296470|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296471|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296472|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296473|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296474|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296475|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296729|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296476|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296477|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296478|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296479|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296480|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296481|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296482|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296483|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296484|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296485|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296486|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296487|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296488|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296489|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296490|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296491|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296492|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296493|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296494|NCT00136916|E2|Reported Event|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
296495|NCT00136916|E1|Reported Event|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
296496|NCT00136955|B1|Baseline|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
296497|NCT00136955|P1|Participant Flow|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
296498|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
296499|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
296500|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
296501|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
296502|NCT00136955|E1|Reported Event|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
296503|NCT00137046|B3|Baseline|Total|Total of all reporting groups
296504|NCT00137046|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296505|NCT00137046|B1|Baseline|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296506|NCT00137046|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296507|NCT00137046|P1|Participant Flow|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296508|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296509|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296510|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296511|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296512|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296513|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296514|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296515|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296516|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296517|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296518|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296519|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296520|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296521|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296522|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296523|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296524|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296525|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296526|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296527|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296528|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296529|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296530|NCT00137046|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296531|NCT00137046|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296532|NCT00137046|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296533|NCT00137046|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296534|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296535|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296536|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296537|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296538|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296539|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296540|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296541|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296542|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296543|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296544|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296545|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296546|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296547|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296548|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296549|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296550|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296551|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296552|NCT00137046|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
296553|NCT00137046|E1|Reported Event|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
296554|NCT00137111|B5|Baseline|Total|Total of all reporting groups
296555|NCT00137111|B4|Baseline|Non Randomized|Patients not randomized for window study
296556|NCT00137111|B3|Baseline|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
296557|NCT00137111|B2|Baseline|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
296558|NCT00137111|B1|Baseline|Total Therapy|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
296559|NCT00137111|P4|Participant Flow|Non Randomized|Patients not randomized for window study
300779|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
296560|NCT00137111|P3|Participant Flow|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
296561|NCT00137111|P2|Participant Flow|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
296562|NCT00137111|P1|Participant Flow|Total Therapy|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
296563|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
296564|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
296565|NCT00137111|O2|Outcome|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
296566|NCT00137111|O1|Outcome|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
296567|NCT00137111|O2|Outcome|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
296568|NCT00137111|O1|Outcome|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
296569|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
296570|NCT00137111|O1|Outcome|Patients With High Risk of CNS Relapse|This is a subset of all patients enrolled. It is not a specific treatment arm.
296571|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
296572|NCT00137111|E1|Reported Event|Total Therapy|Total therapy applies to all eligible patients.
296573|NCT00143247|B1|Baseline|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296574|NCT00143247|P1|Participant Flow|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296575|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296576|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296577|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296578|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296579|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296580|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296581|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296582|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296583|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296584|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296585|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296586|NCT00143247|E1|Reported Event|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
296587|NCT00143312|B1|Baseline|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
300780|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
296588|NCT00143312|P1|Participant Flow|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
296589|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
296590|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
296591|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
296592|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
296593|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
296594|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
296595|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
296596|NCT00143312|E1|Reported Event|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
296597|NCT00143455|B5|Baseline|Total|Total of all reporting groups
296598|NCT00143455|B4|Baseline|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296599|NCT00143455|B3|Baseline|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296600|NCT00143455|B2|Baseline|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296733|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296601|NCT00143455|B1|Baseline|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296602|NCT00143455|P4|Participant Flow|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296603|NCT00143455|P3|Participant Flow|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296604|NCT00143455|P2|Participant Flow|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296664|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296605|NCT00143455|P1|Participant Flow|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296606|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296607|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296608|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296609|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296610|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296611|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296612|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296613|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296614|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296615|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296616|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296617|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296618|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296619|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296620|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296621|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296622|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296730|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296623|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296624|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296625|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296626|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
300781|NCT00160199|E2|Reported Event|Prometrium 400 mg/Day|
296627|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296628|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296629|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296630|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296631|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296632|NCT00143455|E4|Reported Event|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296633|NCT00143455|E3|Reported Event|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296634|NCT00143455|E2|Reported Event|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296635|NCT00143455|E1|Reported Event|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
296636|NCT00143507|B3|Baseline|Total|Total of all reporting groups
296637|NCT00143507|B2|Baseline|Placebo|Patients received placebo twice daily.
296638|NCT00143507|B1|Baseline|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296639|NCT00143507|P2|Participant Flow|Placebo|Patients received placebo twice daily.
296640|NCT00143507|P1|Participant Flow|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296641|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296642|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296643|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296644|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296645|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296646|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296647|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296648|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296649|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296650|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296651|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296652|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296653|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296654|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296731|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296656|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296657|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296658|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296659|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296660|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296661|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296662|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296663|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
296666|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296667|NCT00143507|E2|Reported Event|Placebo|Patients received placebo twice daily.
296668|NCT00143507|E1|Reported Event|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
296669|NCT00143598|B3|Baseline|Total|Total of all reporting groups
296670|NCT00143598|B2|Baseline|Placebo ECS|Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle.
296671|NCT00143598|B1|Baseline|Active ECS|Active Elastic Compression Stockings. 30-40 mm Hg
296672|NCT00143598|P2|Participant Flow|Placebo ECS|Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle.
296673|NCT00143598|P1|Participant Flow|Active ECS|Active Elastic Compression Stockings. 30-40 mm Hg
296674|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
296675|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
296676|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
296677|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
296678|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
296679|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
296680|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
296681|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
296682|NCT00143598|E2|Reported Event|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
296683|NCT00143598|E1|Reported Event|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
296684|NCT00143819|B3|Baseline|Total|Total of all reporting groups
296685|NCT00143819|B2|Baseline|Bilateral Comparison Group 2|"bilateral comparison
Placebo Application: Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks"
296686|NCT00143819|B1|Baseline|Bilateral Comparison Group 1|"bilateral comparison
Neuroskin Forte: Subjects will apply study drug sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks"
296687|NCT00143819|P2|Participant Flow|2 (Left Side: Placebo; Right Side: Active)|"bilateral comparison
Subjects randomized to Group 2 applied placebo sprays to the left side of the body and Neuroskin Forte study drug sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks."
296688|NCT00143819|P1|Participant Flow|1 (Left Side: Active; Right Side: Placebo)|"bilateral comparison
Subjects randomized to Group 1 applied Neuroskin Forte study drug sprays to the left side of the body and placebo sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks."
296689|NCT00143819|O2|Outcome|Placebo Spray|"bilateral comparison
Subjects were randomized to apply placebo spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
296690|NCT00143819|O1|Outcome|Neuroskin Forte Spray|"bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
296691|NCT00143819|O2|Outcome|Placebo Spray|"bilateral comparison
Subjects were randomized to apply placebo spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
296692|NCT00143819|O1|Outcome|Neuroskin Forte Spray|"bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
296693|NCT00143819|O2|Outcome|Placebo Spray (Eczema Patients)|"bilateral comparison
Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks."
296694|NCT00143819|O1|Outcome|Neuroskin Forte Spray (Eczema Patients)|"bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
296695|NCT00143819|O2|Outcome|Placebo Spray (Psoriasis Patients)|"bilateral comparison
Subjects were randomized to apply placebo spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
296696|NCT00143819|O1|Outcome|Neuroskin Forte Spray (Psoriasis Patients)|"bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
296697|NCT00143819|O2|Outcome|Placebo Spray|"bilateral comparison
Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks."
296698|NCT00143819|O1|Outcome|Neuroskin Forte Spray|"bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
296699|NCT00143819|E1|Reported Event|Bilateral Comparison: Neuroskin Forte Spray vs Placebo Spray|"bilateral comparison
Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body and placebo spray to the other side of the body, 3 times a day (with optional 4th application), for 8 weeks."
296700|NCT00143845|B1|Baseline|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
296701|NCT00143845|P1|Participant Flow|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
300782|NCT00160199|E1|Reported Event|Prometrium 300 mg/Day|
296702|NCT00143845|O1|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
296703|NCT00143845|O1|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
296704|NCT00143845|O1|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
296705|NCT00143845|E1|Reported Event|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
296706|NCT00144027|B3|Baseline|Total|Total of all reporting groups
296707|NCT00144027|B2|Baseline|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
296708|NCT00144027|B1|Baseline|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
296709|NCT00144027|P2|Participant Flow|Antipsychotic Adherence Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
296710|NCT00144027|P1|Participant Flow|Control|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
296711|NCT00144027|O2|Outcome|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
296712|NCT00144027|O1|Outcome|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
296713|NCT00144027|E2|Reported Event|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
296714|NCT00144027|E1|Reported Event|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
296715|NCT00144170|B3|Baseline|Total|Total of all reporting groups
296716|NCT00144170|B2|Baseline|Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296717|NCT00144170|B1|Baseline|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296718|NCT00144170|P2|Participant Flow|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296719|NCT00144170|P1|Participant Flow|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296720|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296721|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296722|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296723|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296724|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296734|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296735|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296736|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296737|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296738|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296739|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296740|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296741|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296742|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296743|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296744|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296745|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296746|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296747|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296748|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296749|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
300783|NCT00160251|B7|Baseline|Total|Total of all reporting groups
296758|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296759|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296760|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296761|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296762|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296763|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296764|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296765|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296766|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296767|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296768|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296769|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296770|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296771|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296772|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296773|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296774|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296775|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296776|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296777|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296778|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296779|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296780|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296781|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296782|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296783|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296784|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296785|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296786|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296787|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296788|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296789|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296790|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296791|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296792|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296793|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296794|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296795|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296796|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296797|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296798|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296799|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296800|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296801|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296802|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296803|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296804|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296805|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296806|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296807|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296808|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296810|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296811|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296812|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296813|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296814|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296815|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296816|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296817|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296818|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296819|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296820|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296821|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296822|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296823|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296824|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296825|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296826|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296827|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296828|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296829|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296830|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296831|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296832|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296833|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296834|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296835|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296836|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296837|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296838|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296839|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296840|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296841|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296842|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296843|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296844|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296845|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296846|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296847|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296848|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296849|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296850|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296851|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296852|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296853|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296854|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296855|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296856|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296857|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296858|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296859|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296860|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296861|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296862|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296863|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296864|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296865|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296866|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296867|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296868|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296869|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296870|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296871|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296872|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296873|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296874|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296875|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296876|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296877|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296878|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296879|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296880|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296881|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296882|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296883|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296884|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296886|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296887|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296888|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296889|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296890|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296891|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296892|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296893|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296894|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296895|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296896|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296897|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296898|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296899|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296900|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296901|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296902|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296903|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296904|NCT00144170|E2|Reported Event|Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
296905|NCT00144170|E1|Reported Event|Tipranavir(TPV)/Low Dose Ritonavir(r)|
296906|NCT00144300|B3|Baseline|Total|Total of all reporting groups
296907|NCT00144300|B2|Baseline|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296908|NCT00144300|B1|Baseline|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
301078|NCT00162123|B9|Baseline|Total|Total of all reporting groups
296909|NCT00144300|P2|Participant Flow|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296910|NCT00144300|P1|Participant Flow|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296911|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296912|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296913|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296914|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296915|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296916|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296917|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296918|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296919|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296920|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296921|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296922|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296923|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296924|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296925|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296926|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296927|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296928|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296929|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296930|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296931|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296932|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296933|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296934|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296935|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296936|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296937|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296938|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296939|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296940|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296941|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296942|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296943|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296944|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296945|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296946|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296947|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296948|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296949|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296950|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296951|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296952|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296953|NCT00144300|E2|Reported Event|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
296954|NCT00144300|E1|Reported Event|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
296955|NCT00144339|B3|Baseline|Total|Total of all reporting groups
296956|NCT00144339|B2|Baseline|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296957|NCT00144339|B1|Baseline|Placebo|Once daily
296958|NCT00144339|P2|Participant Flow|Tiotropium Bromide Inhalation Capsules 18 mcg|once daily
296959|NCT00144339|P1|Participant Flow|Placebo|once daily
296960|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296961|NCT00144339|O1|Outcome|Placebo|Once daily
296962|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296963|NCT00144339|O1|Outcome|Placebo|Once daily
296964|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296965|NCT00144339|O1|Outcome|Placebo|Once daily
296966|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296967|NCT00144339|O1|Outcome|Placebo|Once daily
296968|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296969|NCT00144339|O1|Outcome|Placebo|Once daily
296970|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296971|NCT00144339|O1|Outcome|Placebo|Once daily
296972|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296973|NCT00144339|O1|Outcome|Placebo|Once daily
296974|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296975|NCT00144339|O1|Outcome|Placebo|Once daily
296976|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296977|NCT00144339|O1|Outcome|Placebo|Once daily
296978|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296979|NCT00144339|O1|Outcome|Placebo|Once daily
296980|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296981|NCT00144339|O1|Outcome|Placebo|Once daily
296982|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296983|NCT00144339|O1|Outcome|Placebo|Once daily
296984|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296985|NCT00144339|O1|Outcome|Placebo|Once daily
296986|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296987|NCT00144339|O1|Outcome|Placebo|Once daily
296988|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296989|NCT00144339|O1|Outcome|Placebo|Once daily
296990|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296991|NCT00144339|O1|Outcome|Placebo|Once daily
296992|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296993|NCT00144339|O1|Outcome|Placebo|Once daily
296994|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296995|NCT00144339|O1|Outcome|Placebo|Once daily
296996|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296997|NCT00144339|O1|Outcome|Placebo|Once daily
296998|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
296999|NCT00144339|O1|Outcome|Placebo|Once daily
297000|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297001|NCT00144339|O1|Outcome|Placebo|Once daily
297002|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297003|NCT00144339|O1|Outcome|Placebo|Once daily
297004|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297005|NCT00144339|O1|Outcome|Placebo|Once daily
297006|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297007|NCT00144339|O1|Outcome|Placebo|Once daily
297008|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297009|NCT00144339|O1|Outcome|Placebo|Once daily
297010|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297011|NCT00144339|O1|Outcome|Placebo|Once daily
297012|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297013|NCT00144339|O1|Outcome|Placebo|Once daily
297014|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297015|NCT00144339|O1|Outcome|Placebo|Once daily
297016|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297017|NCT00144339|O1|Outcome|Placebo|Once daily
297018|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297019|NCT00144339|O1|Outcome|Placebo|Once daily
297020|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297021|NCT00144339|O1|Outcome|Placebo|Once daily
297022|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297023|NCT00144339|O1|Outcome|Placebo|Once daily
297024|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297025|NCT00144339|O1|Outcome|Placebo|Once daily
297026|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297027|NCT00144339|O1|Outcome|Placebo|Once daily
297028|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297029|NCT00144339|O1|Outcome|Placebo|Once daily
297030|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297031|NCT00144339|O1|Outcome|Placebo|Once daily
297032|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297033|NCT00144339|O1|Outcome|Placebo|Once daily
297034|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297035|NCT00144339|O1|Outcome|Placebo|Once daily
297036|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297037|NCT00144339|O1|Outcome|Placebo|Once daily
297038|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297039|NCT00144339|O1|Outcome|Placebo|Once daily
297040|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297041|NCT00144339|O1|Outcome|Placebo|Once daily
297042|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297043|NCT00144339|O1|Outcome|Placebo|Once daily
297044|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297045|NCT00144339|O1|Outcome|Placebo|Once daily
297046|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297047|NCT00144339|O1|Outcome|Placebo|Once daily
297048|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297049|NCT00144339|O1|Outcome|Placebo|Once daily
297050|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297051|NCT00144339|O1|Outcome|Placebo|Once daily
297052|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297053|NCT00144339|O1|Outcome|Placebo|Once daily
297054|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297055|NCT00144339|O1|Outcome|Placebo|Once daily
297056|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297057|NCT00144339|O1|Outcome|Placebo|Once daily
297058|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297059|NCT00144339|O1|Outcome|Placebo|Once daily
297060|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297061|NCT00144339|O1|Outcome|Placebo|Once daily
297062|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297063|NCT00144339|O1|Outcome|Placebo|Once daily
303108|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
297064|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297065|NCT00144339|O1|Outcome|Placebo|Once daily
297066|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297067|NCT00144339|O1|Outcome|Placebo|Once daily
297068|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297069|NCT00144339|O1|Outcome|Placebo|Once daily
297070|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297071|NCT00144339|O1|Outcome|Placebo|Once daily
297072|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297073|NCT00144339|O1|Outcome|Placebo|Once daily
297074|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297075|NCT00144339|O1|Outcome|Placebo|Once daily
297076|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297077|NCT00144339|O1|Outcome|Placebo|Once daily
297078|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297079|NCT00144339|O1|Outcome|Placebo|Once daily
297080|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297081|NCT00144339|O1|Outcome|Placebo|Once daily
297082|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297083|NCT00144339|O1|Outcome|Placebo|Once daily
297084|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297085|NCT00144339|O1|Outcome|Placebo|Once daily
297086|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297087|NCT00144339|O1|Outcome|Placebo|Once daily
297088|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297089|NCT00144339|O1|Outcome|Placebo|Once daily
297090|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297091|NCT00144339|O1|Outcome|Placebo|Once daily
297092|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297093|NCT00144339|O1|Outcome|Placebo|Once daily
297094|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297095|NCT00144339|O1|Outcome|Placebo|Once daily
297096|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297097|NCT00144339|O1|Outcome|Placebo|Once daily
297098|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297099|NCT00144339|O1|Outcome|Placebo|Once daily
297100|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297101|NCT00144339|O1|Outcome|Placebo|Once daily
297102|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297103|NCT00144339|O1|Outcome|Placebo|Once daily
297104|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297105|NCT00144339|O1|Outcome|Placebo|Once daily
297106|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297107|NCT00144339|O1|Outcome|Placebo|Once daily
297108|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297109|NCT00144339|O1|Outcome|Placebo|Once daily
297110|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297111|NCT00144339|O1|Outcome|Placebo|Once daily
297112|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297113|NCT00144339|O1|Outcome|Placebo|Once daily
297114|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297115|NCT00144339|O1|Outcome|Placebo|Once daily
297116|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297117|NCT00144339|O1|Outcome|Placebo|Once daily
297118|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297119|NCT00144339|O1|Outcome|Placebo|Once daily
297120|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297121|NCT00144339|O1|Outcome|Placebo|Once daily
328488|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
297122|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297123|NCT00144339|O1|Outcome|Placebo|Once daily
297124|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297125|NCT00144339|O1|Outcome|Placebo|Once daily
297126|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297127|NCT00144339|O1|Outcome|Placebo|Once daily
297128|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297129|NCT00144339|O1|Outcome|Placebo|Once daily
297130|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297131|NCT00144339|O1|Outcome|Placebo|Once daily
297132|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297133|NCT00144339|O1|Outcome|Placebo|Once daily
297134|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297135|NCT00144339|O1|Outcome|Placebo|Once daily
297136|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297137|NCT00144339|O1|Outcome|Placebo|Once daily
297138|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297139|NCT00144339|O1|Outcome|Placebo|Once daily
297140|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297141|NCT00144339|O1|Outcome|Placebo|Once daily
297142|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297143|NCT00144339|O1|Outcome|Placebo|Once daily
297144|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297145|NCT00144339|O1|Outcome|Placebo|Once daily
297146|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297147|NCT00144339|O1|Outcome|Placebo|Once daily
297148|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297149|NCT00144339|O1|Outcome|Placebo|Once daily
297150|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297151|NCT00144339|O1|Outcome|Placebo|Once daily
297152|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297153|NCT00144339|O1|Outcome|Placebo|Once daily
297154|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297155|NCT00144339|O1|Outcome|Placebo|Once daily
297156|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297157|NCT00144339|O1|Outcome|Placebo|Once daily
297158|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297159|NCT00144339|O1|Outcome|Placebo|Once daily
297160|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297161|NCT00144339|O1|Outcome|Placebo|Once daily
297162|NCT00144339|E2|Reported Event|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
297163|NCT00144339|E1|Reported Event|Placebo|Once daily
297164|NCT00144391|B3|Baseline|Total|Total of all reporting groups
297165|NCT00144391|B2|Baseline|Placebo|"Placebo
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
297166|NCT00144391|B1|Baseline|Transdermal Testosterone Gel|"2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
297167|NCT00144391|P2|Participant Flow|Placebo|"Placebo
placebo gel- 2 pumps per thigh per day for 6 months"
297168|NCT00144391|P1|Participant Flow|Transdermal Testosterone Gel|Transdermal Testosterone gel- 2.0 mg per pump dose 2 pumps per thigh per day for 6 months
297169|NCT00144391|O2|Outcome|Placebo|"Placebo
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
297170|NCT00144391|O1|Outcome|Transdermal Testosterone Gel|"2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
297171|NCT00144391|E2|Reported Event|Placebo|"Placebo
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
297172|NCT00144391|E1|Reported Event|Transdermal Testosterone Gel|"2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
297173|NCT00144781|B5|Baseline|Total|Total of all reporting groups
297174|NCT00144781|B4|Baseline|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
297175|NCT00144781|B3|Baseline|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
297176|NCT00144781|B2|Baseline|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
297177|NCT00144781|B1|Baseline|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
297327|NCT00145496|P1|Participant Flow|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
297178|NCT00144781|P4|Participant Flow|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
297179|NCT00144781|P3|Participant Flow|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
297180|NCT00144781|P2|Participant Flow|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
297181|NCT00144781|P1|Participant Flow|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
297182|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
297183|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
297184|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
297185|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
297186|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
297187|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
297188|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
297189|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
297190|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
297191|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
297192|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
297193|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
297194|NCT00144781|E4|Reported Event|"Aldurazyme|Weekly|1.2 mg/kg***Check Title***"|"Aldurazyme|Weekly|1.2 mg/kg***Check Description***"
297195|NCT00144781|E3|Reported Event|"Aldurazyme|Weekly|0.58 mg/kg***Check Title***"|"Aldurazyme|Weekly|0.58 mg/kg***Check Description***"
297196|NCT00144781|E2|Reported Event|"Aldurazyme|Every Other|Week 1.8 mg/kg***Check Title***"|"Aldurazyme|Every Other|Week 1.8 mg/kg***Check Description***"
297197|NCT00144781|E1|Reported Event|"Aldurazyme|Every Other|Week 1.2 mg/kg***Check Title***"|"Aldurazyme|Every Other|Week 1.2 mg/kg***Check Description***"
297198|NCT00144963|B1|Baseline|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
297199|NCT00144963|P1|Participant Flow|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
297200|NCT00144963|O1|Outcome|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
297201|NCT00144963|E1|Reported Event|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
297202|NCT00145041|B1|Baseline|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
297203|NCT00145041|P1|Participant Flow|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
297204|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
297205|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
297206|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
297207|NCT00145041|E1|Reported Event|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
297208|NCT00145119|B1|Baseline|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
297209|NCT00145119|P1|Participant Flow|Patients|
297210|NCT00145119|O1|Outcome|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
297211|NCT00145119|E1|Reported Event|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction.
297212|NCT00145249|B4|Baseline|Total|Total of all reporting groups
297213|NCT00145249|B3|Baseline|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297214|NCT00145249|B2|Baseline|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297215|NCT00145249|B1|Baseline|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297216|NCT00145249|P3|Participant Flow|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297217|NCT00145249|P2|Participant Flow|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297218|NCT00145249|P1|Participant Flow|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297219|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297220|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297221|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297222|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297348|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
297223|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297224|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297225|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297226|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297227|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297228|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297229|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297230|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297231|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297232|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297233|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297234|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297235|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297236|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297237|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297238|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297239|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297240|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297241|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297242|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297328|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
297243|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297244|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297245|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297246|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297247|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297248|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297249|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297250|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297349|NCT00145509|E2|Reported Event|Placebo|Placebo sublingually BID
297251|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297252|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297253|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297254|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297255|NCT00145249|E3|Reported Event|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
297256|NCT00145249|E2|Reported Event|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
297257|NCT00145249|E1|Reported Event|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
297258|NCT00145327|B4|Baseline|Total|Total of all reporting groups
297259|NCT00145327|B3|Baseline|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297260|NCT00145327|B2|Baseline|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297261|NCT00145327|B1|Baseline|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297262|NCT00145327|P3|Participant Flow|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297263|NCT00145327|P2|Participant Flow|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297264|NCT00145327|P1|Participant Flow|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297265|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297266|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297267|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297268|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297269|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297270|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297271|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297272|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297273|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297274|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297275|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297276|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297277|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297350|NCT00145509|E1|Reported Event|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
297278|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297279|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297280|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297281|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297282|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297283|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297284|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297285|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297286|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297287|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297288|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297289|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297290|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297291|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297292|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297293|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297294|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297295|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297296|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297329|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
297297|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297298|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297299|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297300|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297301|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297302|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297351|NCT00145574|B4|Baseline|Total|Total of all reporting groups
297352|NCT00145574|B3|Baseline|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
297303|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297304|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297305|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297306|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297307|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297308|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297309|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297310|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297311|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297312|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297313|NCT00145327|E3|Reported Event|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
297314|NCT00145327|E2|Reported Event|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
297315|NCT00145327|E1|Reported Event|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
297316|NCT00145418|B1|Baseline|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
297317|NCT00145418|P1|Participant Flow|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. Oxaliplatin:85 mg/m2 on Days 1 and 15 every 28 days Docetaxel:30 mg/m2 on Days 1 and 8 every 28 days.Doses will be calculated using actual body weight unless in the investigators opinion it would be in the patient's best interest to use ideal body weight. Cycles will be repeated every 28 days for a maximum of 6 cycles.
297318|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
297319|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
297320|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
297321|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
297322|NCT00145418|E1|Reported Event|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
297323|NCT00145496|B3|Baseline|Total|Total of all reporting groups
297324|NCT00145496|B2|Baseline|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
297325|NCT00145496|B1|Baseline|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
297326|NCT00145496|P2|Participant Flow|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
297330|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
297331|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
297332|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
297333|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
297334|NCT00145496|E2|Reported Event|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
297335|NCT00145496|E1|Reported Event|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
297336|NCT00145509|B3|Baseline|Total|Total of all reporting groups
297337|NCT00145509|B2|Baseline|Placebo|Placebo sublingually BID
297338|NCT00145509|B1|Baseline|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
297339|NCT00145509|P2|Participant Flow|Placebo|Placebo sublingually BID
297340|NCT00145509|P1|Participant Flow|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
297341|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
297342|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
297343|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
297344|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
297345|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
297346|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
297353|NCT00145574|B2|Baseline|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
297354|NCT00145574|B1|Baseline|Placebo|Placebo similar to active
297355|NCT00145574|P3|Participant Flow|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
297356|NCT00145574|P2|Participant Flow|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
297357|NCT00145574|P1|Participant Flow|Placebo|Placebo similar to active
297358|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
297359|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
297360|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
297361|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
297362|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
297363|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
297364|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
297365|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
297366|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
297367|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
297368|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
297369|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
297370|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
297371|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
297372|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
297373|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
297374|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
297375|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
297539|NCT00145626|B3|Baseline|Total|Total of all reporting groups
297376|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
297377|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
297378|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
297379|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
297380|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
297381|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
297382|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
297383|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
297384|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
297547|NCT00145626|O4|Outcome|9-12 Months After HSCT|Study participants as previously described.
297385|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
297386|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
297387|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
297388|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
297389|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
297390|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
297391|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
297392|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
297393|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
297394|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
297395|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
297396|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
297397|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
297398|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
297399|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
297400|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
297401|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
297402|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
297403|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
297404|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
297405|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
297406|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
297407|NCT00145574|E4|Reported Event|High Dose Colesevelam Open Label Extension|All participants of the Open Label Extension (weeks 8-26) took colesevelam 3.8 grams per day.
297408|NCT00145574|E3|Reported Event|High Dose Colesevelam Double Blind Period|High dose colesevelam 3.8 grams per day taken from day 1 to week 8.
297409|NCT00145574|E2|Reported Event|Low Dose Colesevelam Double Blind Period|Low dose colesevelam 1.9 grams per day taken from day 1 to week 8.
297410|NCT00145574|E1|Reported Event|Placebo Double Blind Period|Placebo taken from day 1 to week 8.
297411|NCT00145587|B3|Baseline|Total|Total of all reporting groups
297412|NCT00145587|B2|Baseline|Sibling|Genetic testing
297413|NCT00145587|B1|Baseline|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
297414|NCT00145587|P2|Participant Flow|Sibling|Genetic testing
297415|NCT00145587|P1|Participant Flow|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
297416|NCT00145587|O2|Outcome|Sibling|Genetic testing
297417|NCT00145587|O1|Outcome|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
297418|NCT00145587|E2|Reported Event|Sibling|Genetic testing
297419|NCT00145587|E1|Reported Event|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
297420|NCT00145600|B5|Baseline|Total|Total of all reporting groups
297421|NCT00145600|B4|Baseline|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:
a. Ann Arbor stage IIB, IIIB, or any IV"
297422|NCT00145600|B3|Baseline|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
297423|NCT00145600|B2|Baseline|Intermediate Risk|"Stage must be classified as one of the following:
Ann Arbor stage IB and IIIA
Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
297424|NCT00145600|B1|Baseline|Favorable Risk|"Ann Arbor stage IA or IIA with:
Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)
< 3 nodal regions involved on the same side of the diaphragm
No extranodal extension of disease"
297425|NCT00145600|P4|Participant Flow|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:
a. Ann Arbor stage IIB, IIIB, or any IV"
297426|NCT00145600|P3|Participant Flow|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
297427|NCT00145600|P2|Participant Flow|Intermediate Risk|"Stage must be classified as one of the following:
Ann Arbor stage IB and IIIA
Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
297428|NCT00145600|P1|Participant Flow|Favorable Risk|"Ann Arbor stage IA or IIA with:
Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)
< 3 nodal regions involved on the same side of the diaphragm
No extranodal extension of disease"
297429|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297430|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297431|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297432|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297433|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297434|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297435|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
304787|NCT00189475|B2|Baseline|Placebo|Treated for 4 months with placebo
297436|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297437|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297438|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297439|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297440|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297441|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297442|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297443|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297444|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297445|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297446|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297447|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297448|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297449|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297450|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297451|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297452|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297453|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297454|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297455|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297456|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297457|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297458|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297459|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297460|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297461|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297668|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.
placebo: placebo (no active drug)"
297462|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297463|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297464|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297465|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297466|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297467|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297468|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297469|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297470|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297471|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297472|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297473|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297474|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297475|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297476|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297477|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297478|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297479|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297480|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297481|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297482|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297483|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297484|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297485|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297486|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297487|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297488|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297489|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297490|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297491|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297492|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297493|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297494|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297495|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297496|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297497|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297498|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297499|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297500|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297501|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297502|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297503|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297504|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297505|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297506|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297507|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297508|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297509|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297510|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297511|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297548|NCT00145626|O3|Outcome|6-9 Months After HSCT|Study participants as previously described.
297512|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297513|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297514|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297515|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297516|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297517|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297518|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297519|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297520|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297521|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297522|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297523|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297524|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
297525|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297526|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
297527|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297528|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
297529|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297530|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
297531|NCT00145600|O4|Outcome|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:
a. Ann Arbor stage IIB, IIIB, or any IV"
297532|NCT00145600|O3|Outcome|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
297533|NCT00145600|O2|Outcome|Intermediate Risk|"Stage must be classified as one of the following:
Ann Arbor stage IB and IIIA
Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
297534|NCT00145600|O1|Outcome|Favorable Risk|"Ann Arbor stage IA or IIA with:
Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)
< 3 nodal regions involved on the same side of the diaphragm
No extranodal extension of disease"
297535|NCT00145600|E4|Reported Event|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:
a. Ann Arbor stage IIB, IIIB, or any IV"
297536|NCT00145600|E3|Reported Event|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
297537|NCT00145600|E2|Reported Event|Intermediate Risk|"Stage must be classified as one of the following:
Ann Arbor stage IB and IIIA
Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
297538|NCT00145600|E1|Reported Event|Favorable Risk|"Ann Arbor stage IA or IIA with:
Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)
< 3 nodal regions involved on the same side of the diaphragm
No extranodal extension of disease"
297540|NCT00145626|B2|Baseline|Expired|"Those participants who did not survive to at least one year post HSCT.
Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297541|NCT00145626|B1|Baseline|Alive|"Group of participants who survived to at least one year post HSCT.
Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297542|NCT00145626|P1|Participant Flow|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297543|NCT00145626|O8|Outcome|4-5 Years After HSCT|Study participants as previously described.
297544|NCT00145626|O7|Outcome|3-4 Years After HSCT|Study participants as previously described.
297545|NCT00145626|O6|Outcome|2-3 Years After HSCT|Study participants as previously described.
297546|NCT00145626|O5|Outcome|1-2 Years After HSCT|Study participants as previously described.
297549|NCT00145626|O2|Outcome|3-6 Months After HSCT|Study participants as previously described.
297550|NCT00145626|O1|Outcome|0-3 Months After HSCT|Study participants as previously described.
297551|NCT00145626|O3|Outcome|Study Participants: 5 Years Post HSCT|All study participants as previously described.
297552|NCT00145626|O2|Outcome|Study Participants: 1 Year Post HSCT|All study participants as previously described.
297553|NCT00145626|O1|Outcome|Study Participants: Before HSCT|All study participants as previously described.
297554|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297555|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297556|NCT00145626|O3|Outcome|Study Participants|"MRD data were collected on four study participants. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297557|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
297558|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
297559|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297560|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
297561|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
297562|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297563|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
297564|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
297565|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297566|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
297567|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
297669|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin"
297568|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297569|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
297570|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
297571|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297572|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
297573|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
297574|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297575|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
297576|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
297577|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297578|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297579|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297580|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297581|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297582|NCT00145626|E1|Reported Event|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.
Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
297583|NCT00145704|B3|Baseline|Total|Total of all reporting groups
297584|NCT00145704|B2|Baseline|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
297585|NCT00145704|B1|Baseline|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
297586|NCT00145704|P2|Participant Flow|Growth Hormone Only|Growth hormone only, no bisphosphonate will be used
297587|NCT00145704|P1|Participant Flow|Bisphosphonate and Growth Hormone|bisphosphonate use and growth hormone use
297588|NCT00145704|O2|Outcome|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
297589|NCT00145704|O1|Outcome|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
297590|NCT00145704|E2|Reported Event|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
297591|NCT00145704|E1|Reported Event|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
297592|NCT00145795|B3|Baseline|Total|Total of all reporting groups
297593|NCT00145795|B2|Baseline|Current Regimen|Patients in this study arm continued their current regimen.
297594|NCT00145795|B1|Baseline|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297595|NCT00145795|P2|Participant Flow|Current Regimen|Patients in this study arm continued their current regimen.
297596|NCT00145795|P1|Participant Flow|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297597|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
297598|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297599|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
297600|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297601|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
297602|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297603|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
297604|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297605|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
297606|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297607|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
297608|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297609|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
297610|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297611|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
297612|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297613|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
306203|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
297614|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297615|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
297616|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297617|NCT00145795|E2|Reported Event|Current Regimen|Patients in this study arm continued their current regimen.
297618|NCT00145795|E1|Reported Event|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
297619|NCT00140140|B4|Baseline|Total|Total of all reporting groups
297620|NCT00140140|B3|Baseline|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297621|NCT00140140|B2|Baseline|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297622|NCT00140140|B1|Baseline|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297623|NCT00140140|P3|Participant Flow|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297624|NCT00140140|P2|Participant Flow|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297625|NCT00140140|P1|Participant Flow|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297626|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297627|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297628|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297629|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
328489|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
297630|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297631|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297632|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297633|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297634|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
298171|NCT00150969|E2|Reported Event|Placebo|dummy pill identicle to vitamin k
298172|NCT00150969|E1|Reported Event|Phyloquinone|5 mg Vitamin K1
297635|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297636|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297637|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297638|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297639|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297640|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297641|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297642|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297643|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297644|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297645|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297646|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297670|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.
placebo: placebo (no active drug)"
298134|NCT00150618|E4|Reported Event|SPD503 (4 mg)|Guanfacine HCl once daily
297647|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297648|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297649|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297650|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297651|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297652|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297653|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297654|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297655|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297656|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297657|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
297658|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
297659|NCT00140140|E2|Reported Event|90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants are from study Part 2.
297660|NCT00140140|E1|Reported Event|80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants from study Parts 1 and 2 are combined.
297661|NCT00140231|B3|Baseline|Total|Total of all reporting groups
297662|NCT00140231|B2|Baseline|Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Metreleptin|"Placebo, administered in same method as active arm.
placebo: placebo (no active drug)"
297663|NCT00140231|B1|Baseline|Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo|"r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin"
297664|NCT00140231|P2|Participant Flow|Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met|"Placebo, administered in same method as active arm.
placebo: placebo (no active drug)"
297665|NCT00140231|P1|Participant Flow|Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo|"Six young, healthy, and lean women (age, 22.8,; BMI,21.7kg/m2) who were eumenor- rheic were enrolled in a clinical researchcenter– based, randomized, cross-over interventional study involving three separate 5-day-long inpatient admissions (22). Six subjects with a cross-over design, enabling paired comparisons, would provide 80% power to detect a difference of 1.4 SD between different conditionsat the conventional
a=0.05 level. In thefirst admission, the subjects were studied in the isocaloric fed state, whereas in the following two admissions the subjects were studied in the prolonged fasting state for 72 h and were randomized to receive either placebo or metreleptin at replacement doses. A cross-over to the opposite arm took place in the later admission so that all six subjects received both placebo and metreleptin.
r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin"
297666|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.
placebo: placebo (no active drug)"
297667|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin"
297671|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin"
297672|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.
placebo: placebo (no active drug)"
297673|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin"
297674|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.
placebo: placebo (no active drug)"
297675|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin"
297676|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.
placebo: placebo (no active drug)"
297677|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin"
297678|NCT00140231|E2|Reported Event|Placebo|"Placebo, administered in same method as active arm.
placebo: placebo (no active drug)"
297679|NCT00140231|E1|Reported Event|Metreleptin|"r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin"
297680|NCT00140244|B1|Baseline|All Study Participants|"r-MetHuLeptin SubQ once daily
r-metHuLeptin/placebo then placebo/r-metHuLeptin"
297681|NCT00140244|P2|Participant Flow|Placebo First, Then r-metHuLeptin|Subcutaneously once daily Placebo first, then r-metHuLeptin both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297682|NCT00140244|P1|Participant Flow|r-MetHuLeptin First, Then Placebo|r-MetHuLeptin subcutaneously once daily first, then Placebo both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
298173|NCT00151320|B3|Baseline|Total|Total of all reporting groups
297683|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297684|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297685|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297686|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297687|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297688|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297689|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297690|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297691|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297692|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297693|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297694|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297695|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297696|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297697|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297698|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297699|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297700|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297701|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297702|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297703|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297704|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297705|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297706|NCT00140244|O1|Outcome|r-metHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297707|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297708|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
297712|NCT00140413|B3|Baseline|Treatment Group 2: Control|Subjects with normal growth were randomized to treatment or to control (no intervention).
297713|NCT00140413|B2|Baseline|Treatment Group 1B: Randomized to GH|Subjects with normal growth were randomized to GH treatment or to control (no intervention).
297714|NCT00140413|B1|Baseline|Treatment Group 1A: Assigned to GH|Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care.
297715|NCT00140413|P2|Participant Flow|Treatment Group 2: Control|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with normal growth were randomized to treatment or to control. The control group received no intervention; however, control subjects were switched (crossed over) to the GH replacement group if, during the course of the study, they met criteria for growth deceleration.
297716|NCT00140413|P1|Participant Flow|Treatment Group 1: Receiving Growth Hormone Treatment|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care. Subjects with normal growth were randomized to treatment or to control (no intervention). The starting dose for GH replacement was calculated as 0.3 mg/kg/wk and subsequently modified based on observed length/height velocity and serum IGF-I levels.
297717|NCT00140413|O3|Outcome|Treatment Group 3: Control Crossed Over to Treatment|3 control subjects were switched (crossed over) to the GH replacement group during the course of the study due to growth deceleration.
298174|NCT00151320|B2|Baseline|Untreated MCL|with untreated mantle cell Non-Hodgkin’s Lymphoma
297718|NCT00140413|O2|Outcome|Treatment Group 2: Control|"Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with normal growth were randomized to treatment or to control. The control group received no intervention; however control subjects were switched (crossed over) to the GH replacement group if, during the course of the study, they met criteria for growth deceleration.
A total of 7 subjects were randomized to the control group, 3 of whom were crossed over to treatment due to growth deceleration. Outcome measures for these 3 who crossed over were analyzed separately, under Treatment Group 3."
297719|NCT00140413|O1|Outcome|Treatment Group 1: Receiving Growth Hormone Treatment|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care. Subjects with normal growth were randomized to treatment or to control (no intervention). The starting daily dose for GH replacement was calculated as 0.3 mg/kg/wk and subsequently modified based on observed length/height velocity and serum IGF-I levels.
297720|NCT00140413|E2|Reported Event|Treatment Group 2: Control|The denominator below (# at risk) is based on the number of subjects in Group 2 who received at least one dose of growth hormone. Per protocol, control subjects received no intervention; however, 3 control subjects were switched (crossed over) to the GH replacement group during the course of the study due to growth deceleration.
297721|NCT00140413|E1|Reported Event|Treatment Group 1: Receiving Growth Hormone Treatment|The denominator below (# at risk) is based on the number of subjects in Group 1 who received at least one dose of growth hormone.
297722|NCT00140426|B3|Baseline|Total|Total of all reporting groups
297723|NCT00140426|B2|Baseline|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297724|NCT00140426|B1|Baseline|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297725|NCT00140426|P2|Participant Flow|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297726|NCT00140426|P1|Participant Flow|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297727|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297728|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297729|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297730|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297731|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297732|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297733|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297734|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297735|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297736|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297737|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: this group of patients received the active study medication. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297738|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
This subject group received placebo tablets which appeared identical to risperidone"
297739|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
298175|NCT00151320|B1|Baseline|Untreated DLBCL|with untreated Diffuse Large B-cell Lymphoma (n = 40)
297740|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297741|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297742|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297743|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297744|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297745|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297746|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297747|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication.
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297748|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. This is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297749|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297750|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297751|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297752|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297753|NCT00140426|E2|Reported Event|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication
Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
297754|NCT00140426|E1|Reported Event|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
297755|NCT00149630|B3|Baseline|Total|Total of all reporting groups
297756|NCT00149630|B2|Baseline|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
297757|NCT00149630|B1|Baseline|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
297758|NCT00149630|P2|Participant Flow|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
297759|NCT00149630|P1|Participant Flow|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
297760|NCT00149630|O2|Outcome|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
298135|NCT00150618|E3|Reported Event|SPD503 (3 mg)|Guanfacine HCl once daily
297761|NCT00149630|O1|Outcome|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
297762|NCT00149630|O4|Outcome|Disulfiram CT/TT|Subjects who received Disulfiram with genotype CT/TT.
297763|NCT00149630|O3|Outcome|Disulfiram CC|Subjects who received Disulfiram with genotype CC.
297764|NCT00149630|O2|Outcome|Placebo CT/TT|Subjects who received placebo with genotype CT/TT.
297765|NCT00149630|O1|Outcome|Placebo CC|Subjects who received placebo with a genotype of CC.
297766|NCT00149630|E2|Reported Event|Placebo|Inactive medicine (placebo)with methadone during study weeks 2-13. Inactive medicine discontinued during study weeks 14-15.
297767|NCT00149630|E1|Reported Event|Disulfarim|250 mg/day with methadone daily during study weeks 2-13. Study medicine discontinued during study weeks 14-15.
297768|NCT00149643|B3|Baseline|Total|Total of all reporting groups
297769|NCT00149643|B2|Baseline|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
297770|NCT00149643|B1|Baseline|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
297771|NCT00149643|P2|Participant Flow|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
297772|NCT00149643|P1|Participant Flow|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
297773|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
297774|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
297775|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
297776|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
297777|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
297778|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
297779|NCT00149643|E2|Reported Event|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
297780|NCT00149643|E1|Reported Event|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
297781|NCT00149669|B3|Baseline|Total|Total of all reporting groups
297782|NCT00149669|B2|Baseline|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
297783|NCT00149669|B1|Baseline|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
297784|NCT00149669|P2|Participant Flow|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
297785|NCT00149669|P1|Participant Flow|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
297786|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
297787|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
297788|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
297789|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
297790|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
297791|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
297792|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
297793|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
297794|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
297795|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
297796|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
306204|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
297797|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
297798|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
297799|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
297800|NCT00149669|E2|Reported Event|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
297801|NCT00149669|E1|Reported Event|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
297802|NCT00149747|B3|Baseline|Total|Total of all reporting groups
297803|NCT00149747|B2|Baseline|Attention-Control (Health Education) Group|"Weekly general health education classes
Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
297804|NCT00149747|B1|Baseline|Exercise Group|"Regular, aerobic endurance physical activity
Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
297805|NCT00149747|P2|Participant Flow|Attention-Control (Health Education) Group|"Weekly general health education classes
Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
297806|NCT00149747|P1|Participant Flow|Exercise Group|"Regular, aerobic endurance physical activity
Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
297807|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes
Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
297808|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity
Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
297809|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes
Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
297810|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity
Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
297811|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes
Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
297812|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity
Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
297813|NCT00149747|E2|Reported Event|Attention-Control (Health Education) Group|"Weekly general health education classes
Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
298136|NCT00150618|E2|Reported Event|SPD503 (2 mg)|Guanfacine HCl once daily
298137|NCT00150618|E1|Reported Event|SPD503 (1 mg)|Guanfacine HCl once daily
297814|NCT00149747|E1|Reported Event|Exercise Group|"Regular, aerobic endurance physical activity
Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
297815|NCT00149799|B3|Baseline|Total|Total of all reporting groups
297816|NCT00149799|B2|Baseline|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
297817|NCT00149799|B1|Baseline|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
297818|NCT00149799|P3|Participant Flow|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
297819|NCT00149799|P2|Participant Flow|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
297820|NCT00149799|P1|Participant Flow|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
298442|NCT00152009|E1|Reported Event|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
297821|NCT00149799|O1|Outcome|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
297822|NCT00149799|O2|Outcome|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
297823|NCT00149799|O1|Outcome|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
297824|NCT00149799|E3|Reported Event|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
297825|NCT00149799|E2|Reported Event|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
297826|NCT00149799|E1|Reported Event|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
297827|NCT00149825|B3|Baseline|Total|Total of all reporting groups
297828|NCT00149825|B2|Baseline|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
297829|NCT00149825|B1|Baseline|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
297830|NCT00149825|P2|Participant Flow|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
297831|NCT00149825|P1|Participant Flow|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
297832|NCT00149825|O2|Outcome|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
297833|NCT00149825|O1|Outcome|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
297834|NCT00149825|O2|Outcome|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
297835|NCT00149825|O1|Outcome|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
297836|NCT00149825|E2|Reported Event|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
297837|NCT00149825|E1|Reported Event|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
297838|NCT00149890|B3|Baseline|Total|Total of all reporting groups
297839|NCT00149890|B2|Baseline|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
297840|NCT00149890|B1|Baseline|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
297841|NCT00149890|P2|Participant Flow|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
297842|NCT00149890|P1|Participant Flow|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
297843|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
297844|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
297871|NCT00150176|P2|Participant Flow|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
297845|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
297846|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
297847|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
298443|NCT00153816|B7|Baseline|Total|Total of all reporting groups
299823|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
297848|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
297849|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
297850|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
297851|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
297852|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
297853|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
297854|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
297855|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
297856|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
297857|NCT00149890|E2|Reported Event|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
297858|NCT00149890|E1|Reported Event|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
297859|NCT00149994|B3|Baseline|Total|Total of all reporting groups
297860|NCT00149994|B2|Baseline|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
297861|NCT00149994|B1|Baseline|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
297874|NCT00150176|O1|Outcome|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
299007|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
297862|NCT00149994|P2|Participant Flow|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
297863|NCT00149994|P1|Participant Flow|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
297864|NCT00149994|O2|Outcome|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
297865|NCT00149994|O1|Outcome|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
297866|NCT00149994|E2|Reported Event|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
297867|NCT00149994|E1|Reported Event|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
297868|NCT00150176|B3|Baseline|Total|Total of all reporting groups
297869|NCT00150176|B2|Baseline|Placebo|Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
297870|NCT00150176|B1|Baseline|Asenapine|Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
298138|NCT00150969|B3|Baseline|Total|Total of all reporting groups
297872|NCT00150176|P1|Participant Flow|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
297873|NCT00150176|O2|Outcome|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
297966|NCT00150462|P2|Participant Flow|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297875|NCT00150176|O2|Outcome|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
297876|NCT00150176|O1|Outcome|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
297877|NCT00150176|E3|Reported Event|Asenapine During Open-Label Phase and Not Randomized|Adverse Events for the Open-Label period. The 'Asenapine During Open-Label Phase & Not Randomized' Group includes subjects who received >= 1 dose of asenapine during the 26 week open-label phase, and did NOT continue to double-blind phase.
297878|NCT00150176|E2|Reported Event|Placebo|Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
297879|NCT00150176|E1|Reported Event|Asenapine|Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
297880|NCT00150345|B3|Baseline|Total|Total of all reporting groups
297881|NCT00150345|B2|Baseline|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297882|NCT00150345|B1|Baseline|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297883|NCT00150345|P2|Participant Flow|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297884|NCT00150345|P1|Participant Flow|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297885|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297886|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297887|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297888|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
298139|NCT00150969|B2|Baseline|Placebo|dummy pill identicle to vitamin k
297889|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297967|NCT00150462|P1|Participant Flow|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
299008|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
297890|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297891|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297892|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297893|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297894|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297895|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297896|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297897|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297898|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297899|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297900|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297957|NCT00150462|P11|Participant Flow|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
298140|NCT00150969|B1|Baseline|Phyloquinone|5 mg Vitamin K1
297901|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297902|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297903|NCT00150345|O2|Outcome|Deferred Voricoazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297904|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297905|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297906|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297907|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297908|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297909|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297910|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297911|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297912|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297958|NCT00150462|P10|Participant Flow|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
297959|NCT00150462|P9|Participant Flow|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297913|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297914|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297915|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297916|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297917|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297918|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297919|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297920|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297921|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297922|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297923|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297924|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297960|NCT00150462|P8|Participant Flow|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297961|NCT00150462|P7|Participant Flow|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297925|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297926|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297927|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297928|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297929|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297930|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297931|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297932|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297933|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297934|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297935|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297936|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297962|NCT00150462|P6|Participant Flow|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297963|NCT00150462|P5|Participant Flow|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297937|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297938|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297939|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297940|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297941|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297942|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297943|NCT00150345|E2|Reported Event|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297944|NCT00150345|E1|Reported Event|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
297945|NCT00150462|B12|Baseline|Total|Total of all reporting groups
297946|NCT00150462|B11|Baseline|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
297947|NCT00150462|B10|Baseline|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
297948|NCT00150462|B9|Baseline|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297949|NCT00150462|B8|Baseline|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297950|NCT00150462|B7|Baseline|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297951|NCT00150462|B6|Baseline|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297952|NCT00150462|B5|Baseline|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297953|NCT00150462|B4|Baseline|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297954|NCT00150462|B3|Baseline|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297955|NCT00150462|B2|Baseline|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297956|NCT00150462|B1|Baseline|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298119|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
298120|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
297964|NCT00150462|P4|Participant Flow|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297965|NCT00150462|P3|Participant Flow|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298146|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
297968|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
297969|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297970|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297971|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297972|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297973|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297974|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297975|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297976|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297977|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297978|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
297979|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297980|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297981|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297982|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297983|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297984|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297985|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297986|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297987|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297988|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
297989|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297990|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297991|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297992|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297993|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297994|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297995|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297996|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298121|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
297997|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
297998|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
297999|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
298147|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
298000|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298001|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298002|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298003|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298004|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298005|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298006|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298007|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298008|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298009|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
298010|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
298011|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298012|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298013|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298014|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298015|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298016|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298017|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298018|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298019|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298020|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
298021|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
298022|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298023|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298024|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298025|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298026|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298027|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298028|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298029|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298030|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298031|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
298032|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
298033|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298034|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298035|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298036|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298037|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298038|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298039|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298040|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298041|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298042|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
298043|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298044|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298045|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298046|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298047|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298048|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298049|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298050|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298051|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298052|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
298053|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
298054|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298055|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298056|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298057|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298058|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298059|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298060|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298122|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
298123|NCT00150618|O5|Outcome|Placebo|once daily
298061|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298062|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298148|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
298149|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
298150|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
298151|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
298063|NCT00150462|E11|Reported Event|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
298064|NCT00150462|E10|Reported Event|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
298065|NCT00150462|E9|Reported Event|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298066|NCT00150462|E8|Reported Event|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298067|NCT00150462|E7|Reported Event|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298068|NCT00150462|E6|Reported Event|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298069|NCT00150462|E5|Reported Event|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298070|NCT00150462|E4|Reported Event|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298071|NCT00150462|E3|Reported Event|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298072|NCT00150462|E2|Reported Event|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298073|NCT00150462|E1|Reported Event|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
298074|NCT00150592|B3|Baseline|Total|Total of all reporting groups
298075|NCT00150592|B2|Baseline|Placebo|
298076|NCT00150592|B1|Baseline|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
298077|NCT00150592|P2|Participant Flow|Placebo|
298078|NCT00150592|P1|Participant Flow|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
298079|NCT00150592|O2|Outcome|Placebo|
298080|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
298081|NCT00150592|O2|Outcome|Placebo|
298082|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
298083|NCT00150592|O2|Outcome|Placebo|
298084|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
298085|NCT00150592|O2|Outcome|Placebo|
298086|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
298087|NCT00150592|O2|Outcome|Placebo|
298088|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
298089|NCT00150592|O2|Outcome|Placebo|
298090|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
298091|NCT00150592|O2|Outcome|Placebo|
298092|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
298093|NCT00150592|O2|Outcome|Placebo|
298094|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
298095|NCT00150592|E2|Reported Event|Placebo|
298096|NCT00150592|E1|Reported Event|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
298097|NCT00150618|B6|Baseline|Total|Total of all reporting groups
298098|NCT00150618|B5|Baseline|Placebo|once daily
298099|NCT00150618|B4|Baseline|SPD503 (4 mg)|Guanfacine HCl once daily
298100|NCT00150618|B3|Baseline|SPD503 (3 mg)|Guanfacine HCl once daily
298101|NCT00150618|B2|Baseline|SPD503 (2 mg)|Guanfacine HCl once daily
298102|NCT00150618|B1|Baseline|SPD503 (1 mg)|Guanfacine HCl once daily
298103|NCT00150618|P5|Participant Flow|Placebo|once daily
298104|NCT00150618|P4|Participant Flow|SPD503 (4 mg)|Guanfacine HCl once daily
298105|NCT00150618|P3|Participant Flow|SPD503 (3 mg)|Guanfacine HCl once daily
298106|NCT00150618|P2|Participant Flow|SPD503 (2 mg)|Guanfacine HCl once daily
298107|NCT00150618|P1|Participant Flow|SPD503 (1 mg)|Guanfacine HCl once daily
298108|NCT00150618|O5|Outcome|Placebo|once daily
298109|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
298110|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
298111|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
298112|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
298113|NCT00150618|O5|Outcome|Placebo|once daily
298114|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
298115|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
298116|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
298117|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
298118|NCT00150618|O5|Outcome|Placebo|once daily
298141|NCT00150969|P2|Participant Flow|Placebo|dummy pill identicle to vitamin k
298142|NCT00150969|P1|Participant Flow|Phyloquinone|5 mg Vitamin K1
298143|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
298144|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
298145|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
298176|NCT00151320|P1|Participant Flow|Arm 1|"Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles
Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.
Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:
Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4"
298177|NCT00151320|O2|Outcome|Untreated MCL|with untreated mantle cell Non-Hodgkin’s Lymphoma
298178|NCT00151320|O1|Outcome|Untreated DLBCL|with untreated Diffuse Large B-cell Lymphoma (n = 40)
298179|NCT00151320|E1|Reported Event|Arm 1|"Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles
Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.
Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:
Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4"
298180|NCT00151372|B3|Baseline|Total|Total of all reporting groups
298181|NCT00151372|B2|Baseline|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
298182|NCT00151372|B1|Baseline|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
298183|NCT00151372|P2|Participant Flow|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
298184|NCT00151372|P1|Participant Flow|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
298185|NCT00151372|O2|Outcome|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
298186|NCT00151372|O1|Outcome|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
298187|NCT00151372|O2|Outcome|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
298188|NCT00151372|O1|Outcome|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
298189|NCT00151372|E2|Reported Event|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
298190|NCT00151372|E1|Reported Event|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
298191|NCT00151411|B3|Baseline|Total|Total of all reporting groups
298192|NCT00151411|B2|Baseline|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
298193|NCT00151411|B1|Baseline|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
298194|NCT00151411|P2|Participant Flow|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
298195|NCT00151411|P1|Participant Flow|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
298196|NCT00151411|O2|Outcome|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
298197|NCT00151411|O1|Outcome|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
298198|NCT00151411|E2|Reported Event|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
298199|NCT00151411|E1|Reported Event|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
298200|NCT00151476|B4|Baseline|Total|Total of all reporting groups
298201|NCT00151476|B3|Baseline|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298202|NCT00151476|B2|Baseline|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298216|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
306205|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
298203|NCT00151476|B1|Baseline|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298204|NCT00151476|P2|Participant Flow|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298205|NCT00151476|P1|Participant Flow|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298206|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298207|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298208|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298209|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298210|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298271|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298211|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298212|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298213|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298214|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298215|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
306206|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
298217|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298218|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298219|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298220|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298221|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298222|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298223|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298224|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298225|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298226|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298227|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298228|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298229|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298256|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298230|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298231|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298232|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298233|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298234|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298235|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298236|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298237|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298272|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298418|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
298238|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298239|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298240|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298241|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298255|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298242|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298243|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298244|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298245|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298246|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298247|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298248|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298249|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298250|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298273|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
328490|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
298251|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298252|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298253|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298254|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298257|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298258|NCT00151476|E1|Reported Event|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
298259|NCT00143390|B3|Baseline|Total|Total of all reporting groups
298260|NCT00143390|B2|Baseline|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298261|NCT00143390|B1|Baseline|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298262|NCT00143390|P2|Participant Flow|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298263|NCT00143390|P1|Participant Flow|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298264|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298265|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298266|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298267|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298268|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298269|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298270|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298419|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
298274|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298275|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298276|NCT00143390|E2|Reported Event|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298277|NCT00143390|E1|Reported Event|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
298278|NCT00143403|B3|Baseline|Total|Total of all reporting groups
298279|NCT00143403|B2|Baseline|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
298280|NCT00143403|B1|Baseline|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
298281|NCT00143403|P2|Participant Flow|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
298282|NCT00143403|P1|Participant Flow|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
298283|NCT00143403|O2|Outcome|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
298284|NCT00143403|O1|Outcome|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
298285|NCT00143403|O2|Outcome|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
298286|NCT00143403|O1|Outcome|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
298287|NCT00143403|E2|Reported Event|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
298288|NCT00143403|E1|Reported Event|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
298289|NCT00151775|B6|Baseline|Total|Total of all reporting groups
298391|NCT00151996|B1|Baseline|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
298290|NCT00151775|B5|Baseline|Cohort C: OM (Olmesartan Medoxomil)|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
298291|NCT00151775|B4|Baseline|Cohort B: Low Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
298292|NCT00151775|B3|Baseline|Cohort B: High Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
298293|NCT00151775|B2|Baseline|Cohort A: Low Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
298294|NCT00151775|B1|Baseline|Cohort A: High Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
298295|NCT00151775|P12|Participant Flow|Cohort C: Placebo in Period 3 (From OM in Period 2)|Subgroup of Cohort C (1-5 years old) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5).
298296|NCT00151775|P11|Participant Flow|Cohort C: OM in Periods 2, 3, 4|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period from day 0 to week 3) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period from week 3 to week 5). In Period 4 (open-label period from weeks 6-51), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
298297|NCT00151775|P10|Participant Flow|Cohort B: Period 4 Open-label OM|All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
298298|NCT00151775|P9|Participant Flow|Cohort B: Placebo in Period 3 (From Low Dose in Period 2)|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
298299|NCT00151775|P8|Participant Flow|Cohort B: Placebo in Period 3 (From High Dose in Period 2)|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan.
298300|NCT00151775|P7|Participant Flow|Cohort B: Low Dose OM in Periods 2, 3|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
328491|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
298301|NCT00151775|P6|Participant Flow|Cohort B: High Dose OM in Periods 2, 3|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
298302|NCT00151775|P5|Participant Flow|Cohort A: Period 4 Open-label OM|All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
298303|NCT00151775|P4|Participant Flow|Cohort A: Placebo in Period 3 (From Low Dose in Period 2)|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
298304|NCT00151775|P3|Participant Flow|Cohort A: Placebo in Period 3 (From High Dose in Period 2)|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan
298305|NCT00151775|P2|Participant Flow|Cohort A: Low Dose OM in Periods 2, 3|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
298306|NCT00151775|P1|Participant Flow|Cohort A: High Dose OM in Periods 2, 3|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
298326|NCT00151775|O2|Outcome|Cohort B|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
298307|NCT00151775|O1|Outcome|Cohort C: OM (Olmesartan Medoxomil)|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
298308|NCT00151775|O3|Outcome|Cohorts A + B: Period 4 Open-label OM|All members of Cohorts A + B (6-16 years old) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
298309|NCT00151775|O2|Outcome|Cohort B: Period 4 Open-label OM|All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
298310|NCT00151775|O1|Outcome|Cohort A: Period 4 Open-label OM|All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
298311|NCT00151775|O2|Outcome|Cohort C: Placebo Period 3|Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group was switched from its Period 2 olmesartan dose of 0.3 mg/kg to placebo.
298312|NCT00151775|O1|Outcome|Cohort C: OM Period 3|Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group continued on its Period 2 olmesartan dose of 0.3 mg/kg.
298313|NCT00151775|O6|Outcome|Cohorts A + B: Placebo Period 3|Cohorts A + B participants were 6-16 years old. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
298314|NCT00151775|O5|Outcome|Cohorts A + B: OM Period 3|Cohort A + B participants were 6-16 years old. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
298315|NCT00151775|O4|Outcome|Cohort B: Placebo Period 3|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
298316|NCT00151775|O3|Outcome|Cohort B: OM Period 3|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
298317|NCT00151775|O2|Outcome|Cohort A: Placebo Period 3|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
298318|NCT00151775|O1|Outcome|Cohort A: OM Period 3|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
298319|NCT00151775|O6|Outcome|Cohorts A + B: High Dose OM|Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
298414|NCT00152009|P1|Participant Flow|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
298415|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
298320|NCT00151775|O5|Outcome|Cohorts A + B: Low Dose OM|Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
298321|NCT00151775|O4|Outcome|Cohort B: High Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
298322|NCT00151775|O3|Outcome|Cohort B: Low Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
298323|NCT00151775|O2|Outcome|Cohort A: High Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
298324|NCT00151775|O1|Outcome|Cohort A: Low Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
298325|NCT00151775|O3|Outcome|Cohorts A + B|Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
298440|NCT00152009|E3|Reported Event|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
298327|NCT00151775|O1|Outcome|Cohort A|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
298328|NCT00151775|E18|Reported Event|Cohort C: Period 4 Open-label OM|Participants received an olmesartan medoxomil suspension (OM) starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
298329|NCT00151775|E17|Reported Event|Cohort C: Period 3 Placebo|The 0.3 mg/kg dose of olmesartan medoxomil suspension (OM) was discontinued for these participants. They were switched to placebo.
298330|NCT00151775|E16|Reported Event|Cohort C: Period 3 OM Dose Continued|The 0.3 mg/kg dose of OM was continued for these participants
298331|NCT00151775|E15|Reported Event|Cohort C: Period 2 Open-label OM|The dose of olmesartan medoxomil suspension (OM) was 0.3 mg/kg for all particpants who were 1 to 5 years of age.
298332|NCT00151775|E14|Reported Event|Cohort B: Period 4 Open-label OM|10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on particpant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
298333|NCT00151775|E13|Reported Event|Cohort B: Period 3 Placebo From Low Dose|Placebo was given instead of the previous low dose of olmesartan
298334|NCT00151775|E12|Reported Event|Cohort B: Period 3 OM Low Dose Continued|The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
298335|NCT00151775|E11|Reported Event|Cohort B: Period 3 Placebo From High Dose|Placebo was given instead of the previous high dose of olmesartan
298336|NCT00151775|E10|Reported Event|Cohort B: Period 3 OM High Dose Continued|The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
298337|NCT00151775|E9|Reported Event|Cohort B: Period 2 Low Dose OM|For Cohort B (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
298338|NCT00151775|E8|Reported Event|Cohort B: Period 2 High Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
298339|NCT00151775|E7|Reported Event|Cohort A: Period 4 Open-label OM|10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on participant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
298340|NCT00151775|E6|Reported Event|Cohort A: Period 3 Placebo From Low Dose|Placebo was given instead of the previous low dose of olmesartan
298341|NCT00151775|E5|Reported Event|Cohort A: Period 3 OM Low Dose Continued|The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
298342|NCT00151775|E4|Reported Event|Cohort A: Period 3 Placebo From High Dose|Placebo was given instead of the previous high dose of olmesartan
298343|NCT00151775|E3|Reported Event|Cohort A: Period 3 OM High Dose Continued|The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
298344|NCT00151775|E2|Reported Event|Cohort A: Period 2 Low Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
298345|NCT00151775|E1|Reported Event|Cohort A: Period 2 High Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
298346|NCT00151814|B4|Baseline|Total|Total of all reporting groups
298347|NCT00151814|B3|Baseline|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298416|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
328492|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
298348|NCT00151814|B2|Baseline|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298349|NCT00151814|B1|Baseline|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298350|NCT00151814|P3|Participant Flow|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298351|NCT00151814|P2|Participant Flow|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298352|NCT00151814|P1|Participant Flow|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298353|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298354|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298390|NCT00151996|B2|Baseline|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
298355|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298356|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298357|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298358|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298359|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298360|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298361|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298362|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298363|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298364|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298365|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298366|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298367|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298368|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298369|NCT00151814|E3|Reported Event|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298417|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
328493|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
298370|NCT00151814|E2|Reported Event|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298371|NCT00151814|E1|Reported Event|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
298372|NCT00151892|B3|Baseline|Total|Total of all reporting groups
298373|NCT00151892|B2|Baseline|Asacol|1.6g/day administered 800 mg BID
298374|NCT00151892|B1|Baseline|SPD476|2.4 g/day QD
298375|NCT00151892|P2|Participant Flow|Asacol|1.6g/day administered 800 mg twice daily (BID)
298376|NCT00151892|P1|Participant Flow|SPD476|2.4 g/day once daily (QD)
298377|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
298378|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
298379|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
298380|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
298381|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
298382|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
298383|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
298384|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
298385|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
298386|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
298387|NCT00151892|E2|Reported Event|Asacol|1.6g/day administered 800 mg BID
298388|NCT00151892|E1|Reported Event|SPD476|2.4 g/day QD
298389|NCT00151996|B3|Baseline|Total|Total of all reporting groups
298441|NCT00152009|E2|Reported Event|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
298392|NCT00151996|P2|Participant Flow|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
298393|NCT00151996|P1|Participant Flow|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
298394|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
298395|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
298396|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
298397|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
298398|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
298399|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
298400|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
298401|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
298402|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
298403|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
298404|NCT00151996|E2|Reported Event|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
298405|NCT00151996|E1|Reported Event|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
298406|NCT00152009|B5|Baseline|Total|Total of all reporting groups
298407|NCT00152009|B4|Baseline|Placebo|Subjects were randomized to receive Placebo once-daily.
298408|NCT00152009|B3|Baseline|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
298409|NCT00152009|B2|Baseline|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
298410|NCT00152009|B1|Baseline|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
298411|NCT00152009|P4|Participant Flow|Placebo|Subjects were randomized to receive Placebo once-daily.
298412|NCT00152009|P3|Participant Flow|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
298413|NCT00152009|P2|Participant Flow|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
298420|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
298421|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
298422|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
298423|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
298424|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
298425|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
298426|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
298427|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
298428|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
298429|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
298430|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
298431|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
298432|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
298433|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
298434|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
298435|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
298436|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
298437|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
298438|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
298439|NCT00152009|E4|Reported Event|Placebo|Subjects were randomized to receive Placebo once-daily.
298444|NCT00153816|B6|Baseline|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298445|NCT00153816|B5|Baseline|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
298446|NCT00153816|B4|Baseline|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298447|NCT00153816|B3|Baseline|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298448|NCT00153816|B2|Baseline|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
298449|NCT00153816|B1|Baseline|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day"
298450|NCT00153816|P6|Participant Flow|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298451|NCT00153816|P5|Participant Flow|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
298452|NCT00153816|P4|Participant Flow|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298453|NCT00153816|P3|Participant Flow|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298454|NCT00153816|P2|Participant Flow|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
298455|NCT00153816|P1|Participant Flow|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day"
298456|NCT00153816|O6|Outcome|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298457|NCT00153816|O5|Outcome|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
298458|NCT00153816|O4|Outcome|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298459|NCT00153816|O3|Outcome|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298460|NCT00153816|O2|Outcome|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
298461|NCT00153816|O1|Outcome|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day"
298462|NCT00153816|O6|Outcome|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298463|NCT00153816|O5|Outcome|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
298464|NCT00153816|O4|Outcome|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298465|NCT00153816|O3|Outcome|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298466|NCT00153816|O2|Outcome|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
298467|NCT00153816|O1|Outcome|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day"
298468|NCT00153816|E6|Reported Event|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298469|NCT00153816|E5|Reported Event|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
298470|NCT00153816|E4|Reported Event|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
299890|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
298471|NCT00153816|E3|Reported Event|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
298472|NCT00153816|E2|Reported Event|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
298473|NCT00153816|E1|Reported Event|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day"
298474|NCT00153920|B1|Baseline|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
298475|NCT00153920|P1|Participant Flow|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
298476|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
298477|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
298478|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
298479|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
298480|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
298481|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
298482|NCT00153920|E1|Reported Event|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
298483|NCT00153985|B1|Baseline|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
298484|NCT00153985|P1|Participant Flow|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
298485|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
298486|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
298487|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
298488|NCT00153985|E1|Reported Event|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
298489|NCT00154063|B3|Baseline|Total|Total of all reporting groups
298490|NCT00154063|B2|Baseline|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298491|NCT00154063|B1|Baseline|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298492|NCT00154063|P2|Participant Flow|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298493|NCT00154063|P1|Participant Flow|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298494|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298959|NCT00147316|P1|Participant Flow|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
298495|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298496|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298497|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298498|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298499|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298500|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298501|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298502|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298503|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298504|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298505|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298506|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298507|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298670|NCT00156065|B1|Baseline|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
298508|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298509|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298510|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298511|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298512|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298513|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298514|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298515|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298516|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
299891|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
298517|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298518|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298519|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298520|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298521|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298522|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298523|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298524|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298525|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298526|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298527|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298528|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298529|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298671|NCT00156065|P3|Participant Flow|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
328494|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
298530|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298531|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298532|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298533|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298534|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298535|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298536|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298537|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298960|NCT00147316|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
298538|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298539|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298540|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298541|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298542|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298543|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298544|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298545|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298546|NCT00154063|E2|Reported Event|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298547|NCT00154063|E1|Reported Event|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
298548|NCT00154102|B3|Baseline|Total|Total of all reporting groups
298549|NCT00154102|B2|Baseline|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298550|NCT00154102|B1|Baseline|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298551|NCT00154102|P2|Participant Flow|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298571|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298552|NCT00154102|P1|Participant Flow|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298553|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298554|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298555|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298556|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298557|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298605|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
298558|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298559|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298560|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298561|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298562|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298563|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298564|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298565|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298566|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298567|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298568|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298569|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298570|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298672|NCT00156065|P2|Participant Flow|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
328495|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
298572|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298573|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298574|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298575|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298576|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298577|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298578|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298579|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298580|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298581|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298582|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
298583|NCT00154102|E2|Reported Event|FOLFIRI Alone|"Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops.
Safety population: includes all treated subjects"
298584|NCT00154102|E1|Reported Event|Cetuximab Plus FOLFIRI|"Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops.
Safety population: includes all treated subjects."
298585|NCT00154284|B3|Baseline|Total|Total of all reporting groups
298586|NCT00154284|B2|Baseline|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298587|NCT00154284|B1|Baseline|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298588|NCT00154284|P2|Participant Flow|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
328496|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
298589|NCT00154284|P1|Participant Flow|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298590|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298591|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298646|NCT00154375|E2|Reported Event|Period With Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily.
298592|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298593|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298594|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298595|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298596|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298597|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298598|NCT00154284|E2|Reported Event|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298641|NCT00154375|O2|Outcome|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
328497|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
298599|NCT00154284|E1|Reported Event|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
298600|NCT00154297|B3|Baseline|Total|Total of all reporting groups
298601|NCT00154297|B2|Baseline|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
298602|NCT00154297|B1|Baseline|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
298603|NCT00154297|P2|Participant Flow|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
298604|NCT00154297|P1|Participant Flow|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
298606|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
298607|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
298608|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
298609|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
298610|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
298611|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
298612|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
298613|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
298614|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
298615|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
298616|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
298617|NCT00154297|E2|Reported Event|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
298618|NCT00154297|E1|Reported Event|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
298619|NCT00154310|B3|Baseline|Total|Total of all reporting groups
298620|NCT00154310|B2|Baseline|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
298621|NCT00154310|B1|Baseline|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
298669|NCT00156065|B2|Baseline|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
298820|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
298622|NCT00154310|P2|Participant Flow|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
298623|NCT00154310|P1|Participant Flow|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
298624|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
298625|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
298626|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
298877|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours, followed by normothermia.
298878|NCT00147030|E2|Reported Event|Non-cooled|Standard intensive care
298627|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
298628|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
298629|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
298630|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
298631|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
298632|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
298633|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
298634|NCT00154310|E2|Reported Event|Sandimmun Optoral|Sandimmun Optoral
298635|NCT00154310|E1|Reported Event|Certican|Certican
298636|NCT00154375|B3|Baseline|Total|Total of all reporting groups
298637|NCT00154375|B2|Baseline|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
298638|NCT00154375|B1|Baseline|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
298639|NCT00154375|P2|Participant Flow|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
298640|NCT00154375|P1|Participant Flow|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
298821|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
298642|NCT00154375|O1|Outcome|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
298643|NCT00154375|O2|Outcome|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
298644|NCT00154375|O1|Outcome|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
298645|NCT00154375|E3|Reported Event|Period After Switch to Combination|After every 6 weeks from randomization, depending on the assessment of therapeutic effect, patients were switched from Hydroxyurea (1500 mg/day p.o) to combination arm where patients were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time).
299892|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
298647|NCT00154375|E1|Reported Event|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Patients receiving a daily dose of 800 mg imatinib with 1000 mg HU were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
298648|NCT00154466|B4|Baseline|Total|Total of all reporting groups
298649|NCT00154466|B3|Baseline|Healthy Controls|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
298650|NCT00154466|B2|Baseline|Postinfarction Nontraining Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
298651|NCT00154466|B1|Baseline|Postinfarction Training Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
298652|NCT00154466|P3|Participant Flow|Healthy Controls|For comparison of myocardial perfusion and angiogenic cytokines, 19 age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.
298653|NCT00154466|P2|Participant Flow|Post-infarction Nontraining|in which patients continued their usual lifestyle.
298654|NCT00154466|P1|Participant Flow|Post-infarction Training|which underwent a 3-month cardiac rehabilitation program
298655|NCT00154466|O3|Outcome|Healthy Controls|19 age- and sex-matched healthy volunteers
298656|NCT00154466|O2|Outcome|Post-infarction Nontraining|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
298657|NCT00154466|O1|Outcome|Post-infarction Training|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
298658|NCT00154466|O2|Outcome|Post-infarction Nontraining|Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
298659|NCT00154466|O1|Outcome|Post-infarction Training|Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
298660|NCT00154466|E3|Reported Event|Healthy Controls|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
298661|NCT00154466|E2|Reported Event|Postinfarction Nontraining Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
298662|NCT00154466|E1|Reported Event|Postinfarction Training Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
298663|NCT00156013|B1|Baseline|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
298664|NCT00156013|P1|Participant Flow|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
298665|NCT00156013|O1|Outcome|Clofarabine|During the Phase I part of the study, the starting dose of clofarabine will be 4 mg/m2 administered by IVI over 1 hour for 5 consecutive days and repeated every 28 days until disease progression is observed or for a maximum of 6 cycles. Cohorts of 3 patients each will receive doses of clofarabine increased in increments of 2mg/m2. The MTD was 6mg/m2. The dose level immediately below the MTD (4mg/m2) will be used to treat patients in the Phase II part of the study.
298666|NCT00156013|E1|Reported Event|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
298667|NCT00156065|B4|Baseline|Total|Total of all reporting groups
298668|NCT00156065|B3|Baseline|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
298673|NCT00156065|P1|Participant Flow|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
298674|NCT00156065|O3|Outcome|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
298675|NCT00156065|O2|Outcome|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
298676|NCT00156065|O1|Outcome|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
298677|NCT00156065|O3|Outcome|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
298678|NCT00156065|O2|Outcome|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
298679|NCT00156065|O1|Outcome|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
298680|NCT00156065|E3|Reported Event|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
298681|NCT00156065|E2|Reported Event|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
298682|NCT00156065|E1|Reported Event|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
298683|NCT00146328|B4|Baseline|Total|Total of all reporting groups
298684|NCT00146328|B3|Baseline|Group 3 (Tipranavir naïve Patients)|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 449 patients were categorized into Group 3. Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.
299893|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
298685|NCT00146328|B2|Baseline|Group 2 (Highly Treatment Experienced Patients)|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 255 patients were categorized into Group 2. Group 2: Patients from 1182.51 who rolled over into 1182.17.
298686|NCT00146328|B1|Baseline|Group 1 (Patients With Varying Degrees of Treatment Experience|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 291 patients were categorized into Group 1. Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48.
298687|NCT00146328|P3|Participant Flow|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298688|NCT00146328|P2|Participant Flow|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298689|NCT00146328|P1|Participant Flow|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298690|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298691|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298692|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298693|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298694|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298695|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298696|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298697|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298698|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298699|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298700|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298701|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298702|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298822|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
298703|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298704|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298705|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298706|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298707|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298708|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298709|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298958|NCT00147316|B1|Baseline|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
306207|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
298710|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298711|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298712|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298713|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298714|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298715|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298716|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298717|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298718|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298719|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298720|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298721|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298722|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298723|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298724|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298725|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298726|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298727|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298728|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298729|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298824|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
298730|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298731|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298732|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298733|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298734|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298735|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298736|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298737|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298738|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298739|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298740|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298741|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298742|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298743|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298744|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298745|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298746|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298747|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298748|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298749|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298750|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298751|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298752|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298753|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298754|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298755|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298756|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298825|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
298757|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298758|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298759|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298760|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298761|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298762|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298763|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298764|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298765|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298766|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298767|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298768|NCT00146328|E3|Reported Event|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
298769|NCT00146328|E2|Reported Event|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
298770|NCT00146328|E1|Reported Event|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
298771|NCT00146757|B1|Baseline|Arms 1 and 2 Combined|
298772|NCT00146757|P2|Participant Flow|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
298773|NCT00146757|P1|Participant Flow|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
298774|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
298775|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
298776|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
298777|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
298778|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
298779|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
298780|NCT00146757|O2|Outcome|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
298781|NCT00146757|O1|Outcome|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
298782|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
298783|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
298784|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
298785|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
298786|NCT00146757|O2|Outcome|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
298787|NCT00146757|O1|Outcome|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
298788|NCT00146757|E1|Reported Event|Aldurazyme ***Check Title***|Aldurazyme ***check title***
298789|NCT00146770|B3|Baseline|Total|Total of all reporting groups
298790|NCT00146770|B2|Baseline|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment.
298791|NCT00146770|B1|Baseline|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment.
298823|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
298792|NCT00146770|P2|Participant Flow|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
298793|NCT00146770|P1|Participant Flow|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
298794|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
298795|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
298796|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
298797|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
298798|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
298799|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
298800|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
298801|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
298802|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
298803|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
298804|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
298805|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
298806|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
298807|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
298808|NCT00146770|E2|Reported Event|"Aldurazyme/|Aldurazyme***Check Title***"|"Aldurazyme/|Aldurazyme***Check Description***"
298809|NCT00146770|E1|Reported Event|"Placebo/|Aldurazyme***Check Title***"|"Placebo/|Aldurazyme***Check Description***"
298810|NCT00146848|B4|Baseline|Total|Total of all reporting groups
298811|NCT00146848|B3|Baseline|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
298812|NCT00146848|B2|Baseline|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
298813|NCT00146848|B1|Baseline|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
298814|NCT00146848|P3|Participant Flow|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
298815|NCT00146848|P2|Participant Flow|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
298816|NCT00146848|P1|Participant Flow|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
298817|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
298818|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
298819|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
328498|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
298826|NCT00146848|E3|Reported Event|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
298827|NCT00146848|E2|Reported Event|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
298828|NCT00146848|E1|Reported Event|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
298829|NCT00147030|B3|Baseline|Total|Total of all reporting groups
298830|NCT00147030|B2|Baseline|Non-cooled|Standard intensive care
298831|NCT00147030|B1|Baseline|Cooled|Whole body mild induced hypothermia 72 hours, commencing by 6 hours of age followed by re-warming to normothermia.
298832|NCT00147030|P2|Participant Flow|Non-cooled|Standard intensive care at normothermia
298833|NCT00147030|P1|Participant Flow|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298834|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298835|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298836|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298837|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298838|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298839|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298840|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298841|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298842|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298843|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298844|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298845|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298846|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298847|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298848|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298849|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298850|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298851|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298852|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298853|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298854|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298855|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours, followed by normothermia.
298856|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298857|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298858|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298859|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
298860|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298861|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
298862|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298863|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
298864|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298865|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
298866|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298867|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
298868|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298869|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
298870|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298871|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
298872|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298873|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
298874|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
298875|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
298876|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
299005|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
298879|NCT00147030|E1|Reported Event|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.
Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
298880|NCT00147199|B3|Baseline|Total|Total of all reporting groups
298881|NCT00147199|B2|Baseline|Placebo|Identical placebo inhalation solution
298882|NCT00147199|B1|Baseline|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298883|NCT00147199|P2|Participant Flow|Placebo|Identical placebo inhalation solution
298884|NCT00147199|P1|Participant Flow|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298885|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298886|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298887|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298888|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298889|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298890|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298891|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298892|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298893|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298894|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298895|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298896|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298897|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298898|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298899|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298900|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298901|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298902|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298903|NCT00147199|E2|Reported Event|Placebo|Identical placebo inhalation solution
298904|NCT00147199|E1|Reported Event|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
298905|NCT00147212|B1|Baseline|Trabectedin|Experimental arm treated with trabectedin (ET-743)
298906|NCT00147212|P1|Participant Flow|Trabectedin|Experimental arm treated with trabectedin (ET-743)
298907|NCT00147212|O1|Outcome|Trabectedin|Men with metastatic castration resistant prostate cancer (CRPC) treated with trabectedin
298908|NCT00147212|E1|Reported Event|Trabectedin|Experimental arm treated with trabectedin (ET-743)
298909|NCT00147225|B7|Baseline|Total|Total of all reporting groups
298910|NCT00147225|B6|Baseline|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
298911|NCT00147225|B5|Baseline|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
298912|NCT00147225|B4|Baseline|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
298913|NCT00147225|B3|Baseline|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
298914|NCT00147225|B2|Baseline|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
298915|NCT00147225|B1|Baseline|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
299316|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
298916|NCT00147225|P6|Participant Flow|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.
Chemotherapy :
Carboplatin [area under the concentration curve (AUC) = 11]; or
AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or
High dose Ifosfamide: 14 gm/m^2."
298917|NCT00147225|P5|Participant Flow|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.
Chemotherapy :
Carboplatin [area under the concentration curve (AUC) = 11]; or
AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or
High dose Ifosfamide: 14 gm/m^2."
298918|NCT00147225|P4|Participant Flow|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1, Chemotherapy (Control Cycle); Beginning Cycle 2, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy (post dose) of 21-28 day treatment cycle.
Chemotherapy :
Carboplatin [area under the concentration curve (AUC) = 11]; or
AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or
High dose Ifosfamide: 14 gm/m^2."
298919|NCT00147225|P3|Participant Flow|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.
Chemotherapy :
Carboplatin [area under the concentration curve (AUC) = 11]; or
AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or
High dose Ifosfamide: 14 gm/m^2."
298920|NCT00147225|P2|Participant Flow|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.
Chemotherapy :
Carboplatin [area under the concentration curve (AUC) = 11]; or
AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or
High dose Ifosfamide: 14 gm/m^2."
298921|NCT00147225|P1|Participant Flow|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.
Chemotherapy :
Carboplatin [area under the concentration curve (AUC) = 11]; or
Adriamycin /Ifosfamide (AI) regimens [Adriamycin (Doxorubicin) 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or
High dose Ifosfamide: 14 gm/m^2"
298922|NCT00147225|O6|Outcome|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
298923|NCT00147225|O5|Outcome|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
298924|NCT00147225|O4|Outcome|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
298925|NCT00147225|O3|Outcome|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
298926|NCT00147225|O2|Outcome|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
298927|NCT00147225|O1|Outcome|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
298928|NCT00147225|O6|Outcome|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
298929|NCT00147225|O5|Outcome|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
298930|NCT00147225|O4|Outcome|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
298931|NCT00147225|O3|Outcome|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
298932|NCT00147225|O2|Outcome|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
298933|NCT00147225|O1|Outcome|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
298934|NCT00147225|E6|Reported Event|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
298935|NCT00147225|E5|Reported Event|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
298936|NCT00147225|E4|Reported Event|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
298937|NCT00147225|E3|Reported Event|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
298938|NCT00147225|E2|Reported Event|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
298939|NCT00147225|E1|Reported Event|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
298940|NCT00147238|B1|Baseline|Ferumoxtran-10 MRI Contrast Agent|
298941|NCT00147238|P1|Participant Flow|Ferumoxtran-10 MRI Contrast Agent|
298942|NCT00147238|O1|Outcome|Ferumoxtran-10 MRI Contrast Agent|
298943|NCT00147238|E1|Reported Event|Ferumoxtran-10 MRI Contrast Agent|
298944|NCT00147277|B3|Baseline|Total|Total of all reporting groups
298945|NCT00147277|B2|Baseline|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
298946|NCT00147277|B1|Baseline|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
298947|NCT00147277|P2|Participant Flow|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
298948|NCT00147277|P1|Participant Flow|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
298949|NCT00147277|O2|Outcome|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
298950|NCT00147277|O1|Outcome|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
298951|NCT00147290|B3|Baseline|Total|Total of all reporting groups
298952|NCT00147290|B2|Baseline|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
298953|NCT00147290|B1|Baseline|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
298954|NCT00147290|P2|Participant Flow|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
298955|NCT00147290|P1|Participant Flow|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
298956|NCT00147290|O2|Outcome|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
298957|NCT00147290|O1|Outcome|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
299006|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
298961|NCT00147316|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
298962|NCT00147316|E1|Reported Event|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
298963|NCT00147446|B3|Baseline|Total|Total of all reporting groups
298964|NCT00147446|B2|Baseline|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
298965|NCT00147446|B1|Baseline|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for multiple sclerosis(SMT-MS)at baseline
298966|NCT00147446|P2|Participant Flow|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided afte the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop.
298967|NCT00147446|P1|Participant Flow|Stress Management Therapy for Mulitple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
298968|NCT00147446|O2|Outcome|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided afte the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop.
298969|NCT00147446|O1|Outcome|Stress Management Therapy for Mulitple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
298970|NCT00147446|O2|Outcome|Wait List Control Condition|Wait list control(WLC) provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
298971|NCT00147446|O1|Outcome|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
298972|NCT00147446|E2|Reported Event|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
298973|NCT00147446|E1|Reported Event|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for MS(SMT-MS, provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
298974|NCT00147498|B5|Baseline|Total|Total of all reporting groups
298975|NCT00147498|B4|Baseline|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
298976|NCT00147498|B3|Baseline|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
298977|NCT00147498|B2|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
298978|NCT00147498|B1|Baseline|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
298979|NCT00147498|P4|Participant Flow|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
298980|NCT00147498|P3|Participant Flow|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
298981|NCT00147498|P2|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
298982|NCT00147498|P1|Participant Flow|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
298983|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
298984|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
298985|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
298986|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
298987|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
298988|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
298989|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
298990|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
298991|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
298992|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
298993|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
298994|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
298995|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
298996|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
298997|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
298998|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
298999|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299000|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299001|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299002|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299003|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299004|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299009|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299010|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299011|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299012|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299013|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299014|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299015|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299016|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299017|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299018|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299019|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299020|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299021|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299022|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299023|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299024|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299025|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299026|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299027|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299028|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299029|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299030|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299031|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299032|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299033|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299034|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299035|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299036|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299037|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299038|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299039|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299040|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299041|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299042|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299043|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299044|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299045|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299046|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299047|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299048|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299049|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299050|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299051|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299052|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299053|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299054|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299055|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299056|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299057|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299058|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299059|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299060|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299061|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299062|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299063|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299064|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299065|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299066|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299067|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299068|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299069|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299070|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299071|NCT00147498|E4|Reported Event|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
299072|NCT00147498|E3|Reported Event|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
299073|NCT00147498|E2|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
299074|NCT00147498|E1|Reported Event|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
299075|NCT00147537|B5|Baseline|Total|Total of all reporting groups
299076|NCT00147537|B4|Baseline|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299077|NCT00147537|B3|Baseline|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299078|NCT00147537|B2|Baseline|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299079|NCT00147537|B1|Baseline|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299080|NCT00147537|P11|Participant Flow|Paclitaxel(P)+Carboplatin(C) (Phase 2)|Paclitaxel (P) 200 mg/square meter (m^2) IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299317|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
299318|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
299081|NCT00147537|P10|Participant Flow|CP-751,871(F)+Paclitaxel(P)+Carboplatin(C) (Phase 2)|Single intravenous (IV) dose of CP‑751,871 (F) 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel (P) 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299082|NCT00147537|P9|Participant Flow|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299083|NCT00147537|P8|Participant Flow|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299084|NCT00147537|P7|Participant Flow|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299085|NCT00147537|P6|Participant Flow|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299335|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
299086|NCT00147537|P5|Participant Flow|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299087|NCT00147537|P4|Participant Flow|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299088|NCT00147537|P3|Participant Flow|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299089|NCT00147537|P2|Participant Flow|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299090|NCT00147537|P1|Participant Flow|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299091|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299092|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299093|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299094|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299319|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
328499|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
299095|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299096|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299097|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299098|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299099|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299100|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299327|NCT00148109|B2|Baseline|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
299101|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299102|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299103|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299104|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299105|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299106|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299107|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299108|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299109|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299110|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299111|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299257|NCT00147537|E11|Reported Event|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299112|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299113|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299114|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299115|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299116|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299328|NCT00148109|B1|Baseline|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
299336|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
299117|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin + Additional CP-751,871 (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
299118|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299119|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299120|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299121|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299122|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299123|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299124|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299125|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299285|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
299286|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
299287|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
299126|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299127|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299128|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299129|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299130|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299131|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299132|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299133|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299134|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299135|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299136|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299137|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299138|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299288|NCT00147745|E3|Reported Event|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
299289|NCT00147745|E2|Reported Event|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
299290|NCT00147745|E1|Reported Event|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
299139|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299140|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299141|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299142|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299143|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299144|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299145|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299146|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299147|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299148|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299149|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299150|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter (mg/mL), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299151|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299291|NCT00147823|B3|Baseline|Total|Total of all reporting groups
299292|NCT00147823|B2|Baseline|Vitoss Only|Vitoss: Synthetic bone graft material alone
299293|NCT00147823|B1|Baseline|Vitoss Used With Bone Marrow Aspirate|Vitoss: Synthetic bone graft material mixed with Bone Marrow aspirate
299152|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299153|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299154|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299155|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299156|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299157|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299158|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299159|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299160|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299161|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299162|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299163|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299164|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299294|NCT00147823|P2|Participant Flow|Vitoss With Bone Marrow Aspirate|"Addition of Vitoss to the bone marrow aspirate
Vitoss : Synthetic bone graft material"
299295|NCT00147823|P1|Participant Flow|Vitoss Alone|No bone marrow aspirate used
299296|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
299165|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299166|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299167|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299168|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299169|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299170|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299171|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299172|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299173|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299174|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299175|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299176|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299177|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299297|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
299298|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
299299|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
299178|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299179|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299180|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299181|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299182|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299183|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299184|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299185|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299186|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299187|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299188|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299189|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299190|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299300|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
299301|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
299302|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
328500|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
299191|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299192|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299193|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299329|NCT00148109|P2|Participant Flow|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
299330|NCT00148109|P1|Participant Flow|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
299194|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299195|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299196|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299197|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299198|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299199|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299200|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299201|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299202|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299203|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299303|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
299304|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
299305|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
299204|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299205|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299206|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299207|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299208|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299209|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299210|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299211|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299212|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299213|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299214|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299215|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299216|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299306|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
299307|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
299308|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
299217|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299218|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299219|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299220|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299221|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299222|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299223|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299224|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299225|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299226|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299227|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299228|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299229|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299309|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
299310|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
299311|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
328501|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
299230|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299231|NCT00147537|O8|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299331|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
299332|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
299333|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
306208|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
299232|NCT00147537|O7|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299233|NCT00147537|O6|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299234|NCT00147537|O5|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299235|NCT00147537|O4|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299236|NCT00147537|O3|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299237|NCT00147537|O2|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299238|NCT00147537|O1|Outcome|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299239|NCT00147537|O8|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299240|NCT00147537|O7|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299241|NCT00147537|O6|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299242|NCT00147537|O5|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299312|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
299313|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
299314|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
299315|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate
Vitoss: Synthetic bone graft material"
299243|NCT00147537|O4|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299244|NCT00147537|O3|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299245|NCT00147537|O2|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299246|NCT00147537|O1|Outcome|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299247|NCT00147537|O2|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299248|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299249|NCT00147537|O2|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299250|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299251|NCT00147537|O1|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299252|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299253|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299254|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299255|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299256|NCT00147537|E12|Reported Event|Paclitaxel + Carboplatin + Additional CP-751,871 (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
299258|NCT00147537|E10|Reported Event|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299259|NCT00147537|E9|Reported Event|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299260|NCT00147537|E8|Reported Event|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299261|NCT00147537|E7|Reported Event|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299262|NCT00147537|E6|Reported Event|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299263|NCT00147537|E5|Reported Event|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299264|NCT00147537|E4|Reported Event|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299265|NCT00147537|E3|Reported Event|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299266|NCT00147537|E2|Reported Event|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299267|NCT00147537|E1|Reported Event|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
299268|NCT00147745|B4|Baseline|Total|Total of all reporting groups
299269|NCT00147745|B3|Baseline|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
299270|NCT00147745|B2|Baseline|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
299271|NCT00147745|B1|Baseline|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
299272|NCT00147745|P3|Participant Flow|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
299273|NCT00147745|P2|Participant Flow|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
299274|NCT00147745|P1|Participant Flow|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
299275|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
299276|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
299277|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
299278|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
299279|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
299280|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
299281|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
299282|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
299283|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
299284|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
299320|NCT00147823|E2|Reported Event|Vitoss With Bone Marrow Aspirate|subjects who received Vitoss with bone marrow aspirate
299321|NCT00147823|E1|Reported Event|Vitoss Without Bone Marrow Aspirate|subjects who received Vitoss without bone marrow aspirate
299322|NCT00147966|B1|Baseline|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
299323|NCT00147966|P1|Participant Flow|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
299324|NCT00147966|O1|Outcome|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
299325|NCT00147966|E1|Reported Event|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
299326|NCT00148109|B3|Baseline|Total|Total of all reporting groups
299334|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
299337|NCT00148109|E2|Reported Event|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
299338|NCT00148109|E1|Reported Event|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
299339|NCT00148122|B1|Baseline|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)
Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
299340|NCT00148122|P1|Participant Flow|Docetaxel and Capecitabine|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)
Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
299341|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)
Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
299342|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)
Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
299343|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)
Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
299344|NCT00148122|E1|Reported Event|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)
Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
299345|NCT00148317|B1|Baseline|Treatment Arm (All Patients)|Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
299346|NCT00148317|P1|Participant Flow|Overall Study|
299347|NCT00148317|O1|Outcome|Treatment Arm (All Patients)|Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
299348|NCT00148317|O1|Outcome|Treatment Arm - Post Bortezomib-based Mobilization|Yield of stem cell collection for the group that underwent bortezomib-based Mobilization
299349|NCT00148317|O2|Outcome|Treatment Arm - Responses Prior to Mobilization|This is the overall best response rate (ORR, ≥PR, as measured by ≥50% reduction in M-protein) to DoVeD therapy from post-primary induction (pre-DoVeD).
299350|NCT00148317|O1|Outcome|Treatment Arm - Post Mobilization|This is the response rate assessed for patients after their bortezomib-based mobilization.
299351|NCT00148317|E1|Reported Event|Treatment Arm (All Patients)|Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
299352|NCT00148668|B3|Baseline|Total|Total of all reporting groups
299353|NCT00148668|B2|Baseline|Arm 2|Taxotere/carboplatin/herceptin
299354|NCT00148668|B1|Baseline|Arm 1|Herceptin/navelbine
299355|NCT00148668|P2|Participant Flow|Taxotere/Carboplatin/Herceptin|Taxotere (75mg/kg2)/carboplatin (AUC6)/herceptin(2mg/kg)[TC q 3 weeks/H q 1 wk) x 4 cycles
299356|NCT00148668|P1|Participant Flow|Herceptin/Navelbine|Herceptin( 2mg/kg)navelbine (25mg/kg2) x 12 weeks
299357|NCT00148668|O2|Outcome|Arm 2|Taxotere/carboplatin/herceptin
299358|NCT00148668|O1|Outcome|Arm 1|Herceptin/navelbine
299359|NCT00148668|E2|Reported Event|Arm 2|Taxotere/carboplatin/herceptin
299360|NCT00148668|E1|Reported Event|Arm 1|Herceptin/navelbine
299361|NCT00148733|B3|Baseline|Total|Total of all reporting groups
299362|NCT00148733|B2|Baseline|Placebo|"Placebo
Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
299363|NCT00148733|B1|Baseline|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water
Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
299587|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299364|NCT00148733|P2|Participant Flow|Placebo|"Placebo
Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
299365|NCT00148733|P1|Participant Flow|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water
Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
299366|NCT00148733|O2|Outcome|Placebo|"Placebo
Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
299367|NCT00148733|O1|Outcome|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water
Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
299368|NCT00148733|E2|Reported Event|Placebo|"Placebo
Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
299369|NCT00148733|E1|Reported Event|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water
Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
299370|NCT00148759|B3|Baseline|Total|Total of all reporting groups
299371|NCT00148759|B2|Baseline|Group 2|Female subjects
299372|NCT00148759|B1|Baseline|Group 1|Male subjects
299373|NCT00148759|P2|Participant Flow|Female Arm|Female subjects
299374|NCT00148759|P1|Participant Flow|Male Arm|Male subjects
299375|NCT00148759|O2|Outcome|Group 2|Female subjects
299376|NCT00148759|O1|Outcome|Group 1|Male subjects
299377|NCT00148759|O2|Outcome|Group 2|Female subjects
299378|NCT00148759|O1|Outcome|Group 1|Male subjects
299379|NCT00148759|E2|Reported Event|Group 2|Female subjects
299380|NCT00148759|E1|Reported Event|Group 1|Male subjects
299381|NCT00148798|B3|Baseline|Total|Total of all reporting groups
299382|NCT00148798|B2|Baseline|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299383|NCT00148798|B1|Baseline|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299384|NCT00148798|P2|Participant Flow|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299385|NCT00148798|P1|Participant Flow|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299386|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299387|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299388|NCT00148798|O2|Outcome|Cetuximab Concentration Before Infusion Week 7|
299389|NCT00148798|O1|Outcome|Cetuximab Concentration at End of Infusion Week 1|
299522|NCT00157014|B3|Baseline|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299390|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299391|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299392|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299393|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299394|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299395|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299396|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299397|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299894|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
299398|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299399|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299400|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299401|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299402|NCT00148798|E2|Reported Event|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299403|NCT00148798|E1|Reported Event|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects."
299404|NCT00148954|B3|Baseline|Total|Total of all reporting groups
299405|NCT00148954|B2|Baseline|Medtronic Family|Selected Medtronic family devices
299406|NCT00148954|B1|Baseline|VITALITY 2|VITALITY 2 ICD
299407|NCT00148954|P2|Participant Flow|Medtronic Family|Selected Medtronic family devices
299408|NCT00148954|P1|Participant Flow|VITALITY 2|VITALITY 2 ICD
299409|NCT00148954|O2|Outcome|Medtronic Family|Selected Medtronic family devices
299410|NCT00148954|O1|Outcome|VITALITY 2|VITALITY 2 ICD
299411|NCT00148954|E2|Reported Event|Medtronic Family|This study did not collect serious adverse events
299412|NCT00148954|E1|Reported Event|VITALITY 2|This study did not collect serious adverse events
299413|NCT00149214|B3|Baseline|Total|Total of all reporting groups
299414|NCT00149214|B2|Baseline|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299415|NCT00149214|B1|Baseline|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299416|NCT00149214|P2|Participant Flow|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299417|NCT00149214|P1|Participant Flow|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299418|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299419|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299523|NCT00157014|B2|Baseline|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299420|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299421|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299422|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299423|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299424|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299425|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299426|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299427|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299895|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
299428|NCT00149214|E2|Reported Event|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299429|NCT00149214|E1|Reported Event|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
299430|NCT00149227|B3|Baseline|Total|Total of all reporting groups
299431|NCT00149227|B2|Baseline|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299432|NCT00149227|B1|Baseline|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299433|NCT00149227|P2|Participant Flow|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299434|NCT00149227|P1|Participant Flow|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299435|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299436|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299437|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299438|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299439|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299440|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299441|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299524|NCT00157014|B1|Baseline|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
328502|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
299442|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299443|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299444|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299445|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299446|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299447|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299539|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299448|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299449|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299450|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299451|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299452|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299453|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299454|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299455|NCT00149227|E2|Reported Event|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
299456|NCT00149227|E1|Reported Event|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
299457|NCT00156247|B1|Baseline|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
299458|NCT00156247|P1|Participant Flow|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
299459|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
299460|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
299461|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
299462|NCT00156247|E1|Reported Event|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
299463|NCT00156390|B3|Baseline|Total|Total of all reporting groups
299464|NCT00156390|B2|Baseline|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)
placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
299465|NCT00156390|B1|Baseline|Echo-guided LV Lead Placement|"echo-guided LV lead placement
echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
299525|NCT00157014|P4|Participant Flow|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299466|NCT00156390|P2|Participant Flow|LV Lead Placement as Per Standard of Care (Without Echo-guida|"LV lead placement as per standard of care (without echo-guidance)
placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
299467|NCT00156390|P1|Participant Flow|Echo-guided LV Lead Placement|"echo-guided LV lead placement
echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
299468|NCT00156390|O2|Outcome|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)
placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
299469|NCT00156390|O1|Outcome|Echo-guided LV Lead Placement|"echo-guided LV lead placement
echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
299470|NCT00156390|E2|Reported Event|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)
placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
299471|NCT00156390|E1|Reported Event|Echo-guided LV Lead Placement|"echo-guided LV lead placement
echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
299472|NCT00156819|B4|Baseline|Total|Total of all reporting groups
299473|NCT00156819|B3|Baseline|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299474|NCT00156819|B2|Baseline|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299475|NCT00156819|B1|Baseline|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299476|NCT00156819|P3|Participant Flow|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299477|NCT00156819|P2|Participant Flow|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299478|NCT00156819|P1|Participant Flow|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299479|NCT00156819|O3|Outcome|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299480|NCT00156819|O2|Outcome|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299481|NCT00156819|O1|Outcome|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299482|NCT00156819|E3|Reported Event|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299483|NCT00156819|E2|Reported Event|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299484|NCT00156819|E1|Reported Event|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
299485|NCT00156910|B3|Baseline|Total|Total of all reporting groups
299486|NCT00156910|B2|Baseline|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
299487|NCT00156910|B1|Baseline|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
299488|NCT00156910|P2|Participant Flow|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
299489|NCT00156910|P1|Participant Flow|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
299490|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
299491|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
299492|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
299493|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
299494|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
299495|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
299496|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
299497|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
299896|NCT00158223|E2|Reported Event|Pimozide|Participants received pimozide flexible dosing
299498|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
299499|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
299500|NCT00156910|E2|Reported Event|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
299501|NCT00156910|E1|Reported Event|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
299502|NCT00156923|B3|Baseline|Total|Total of all reporting groups
299503|NCT00156923|B2|Baseline|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
299504|NCT00156923|B1|Baseline|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
299505|NCT00156923|P2|Participant Flow|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
299506|NCT00156923|P1|Participant Flow|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
299507|NCT00156923|O2|Outcome|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
299508|NCT00156923|O1|Outcome|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
299509|NCT00156923|E2|Reported Event|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
299510|NCT00156923|E1|Reported Event|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
299511|NCT00156936|B3|Baseline|Total|Total of all reporting groups
299512|NCT00156936|B2|Baseline|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
299513|NCT00156936|B1|Baseline|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
299514|NCT00156936|P2|Participant Flow|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
299515|NCT00156936|P1|Participant Flow|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
299516|NCT00156936|O2|Outcome|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
299517|NCT00156936|O1|Outcome|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
299518|NCT00156936|E2|Reported Event|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
299519|NCT00156936|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
299520|NCT00157014|B5|Baseline|Total|Total of all reporting groups
299521|NCT00157014|B4|Baseline|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
328503|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
299526|NCT00157014|P3|Participant Flow|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299527|NCT00157014|P2|Participant Flow|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299528|NCT00157014|P1|Participant Flow|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299529|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299530|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299531|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299532|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299533|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299534|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299535|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299536|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299537|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299538|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
306209|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
299540|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299541|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299542|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299543|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299544|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299545|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299546|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299547|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299548|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299549|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299550|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299551|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299552|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299553|NCT00157014|O2|Outcome|Cyclosporine - Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299554|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299555|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299556|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299557|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299558|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299559|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299560|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299561|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299562|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299563|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299564|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299565|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299566|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299567|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299568|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299569|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299570|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299571|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
300232|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
299572|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299573|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299574|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299575|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299576|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299577|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299578|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299579|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299580|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299581|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299582|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299583|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299584|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299585|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299586|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299588|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299589|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299590|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299591|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299592|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299593|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299594|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299595|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299596|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299597|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299598|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299599|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299600|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299601|NCT00157014|E4|Reported Event|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299602|NCT00157014|E3|Reported Event|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
299603|NCT00157014|E2|Reported Event|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299604|NCT00157014|E1|Reported Event|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
299605|NCT00157157|B1|Baseline|PUPs|
299606|NCT00157157|P1|Participant Flow|Previously Untreated Patients (PUPs)|rAHF-PFM was dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator] or on–demand treatment [dose selected by investigator]). The dosing regimen used to treat bleeding episodes (BEs) was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of bleeding episodes diagnosed.
299607|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
299608|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
299609|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
299610|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
299611|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
299612|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
299613|NCT00157157|O1|Outcome|PUPs|
299614|NCT00157157|O1|Outcome|PUPs|
299615|NCT00157157|O1|Outcome|PUPs|
299616|NCT00157157|O1|Outcome|PUPs|
299617|NCT00157157|O1|Outcome|PUPs|
299618|NCT00157157|O2|Outcome|PUPs -Termination Visit|Incremental recovery at the Termination Study Visit
299619|NCT00157157|O1|Outcome|PUPs -Initial Visit|Incremental recovery at the Initial Study Visit
299620|NCT00157157|O3|Outcome|PUPs -During Perioperative Management|rAHF-PFM was administered intravenously via bolus infusion, or continuous infusion. The dosing regimen used was at the discretion of the investigator and in accordance with the institution’s standard of care.
299621|NCT00157157|O2|Outcome|PUPs -During On-Demand Treatment|The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of BE diagnosed.
299622|NCT00157157|O1|Outcome|PUPs -During Prophylaxis|rAHF-PFM was dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator]. The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of bleeding episode (BE) diagnosed.
299623|NCT00157157|O1|Outcome|PUPs|
299624|NCT00157157|O1|Outcome|PUPs|
299625|NCT00157157|O1|Outcome|PUPs|
299626|NCT00157157|O1|Outcome|PUPs|
299627|NCT00157157|E1|Reported Event|PUPs|
299628|NCT00157196|B1|Baseline|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
299629|NCT00157196|P1|Participant Flow|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 microgram (mcg) of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The best standard of care (BSC) was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
299630|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
299631|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
299632|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
299633|NCT00157196|E1|Reported Event|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
299634|NCT00157209|B3|Baseline|Total|Total of all reporting groups
299635|NCT00157209|B2|Baseline|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299636|NCT00157209|B1|Baseline|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299637|NCT00157209|P2|Participant Flow|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299638|NCT00157209|P1|Participant Flow|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299639|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299640|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
301525|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
299641|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299642|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299643|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299644|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299645|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299646|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299647|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299686|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299687|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299688|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299689|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299690|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299648|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299649|NCT00157209|E2|Reported Event|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299700|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299701|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299702|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299703|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299704|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299705|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
306210|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
299650|NCT00157209|E1|Reported Event|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
299651|NCT00157248|B5|Baseline|Total|Total of all reporting groups
299652|NCT00157248|B4|Baseline|Dabigatran Etexilate, 300 mg BID (Twice Daily)|Dosage used at study start
299653|NCT00157248|B3|Baseline|Dabigatran Etexilate, 300 mg QD (Once Daily)|Dosage used at study start
299654|NCT00157248|B2|Baseline|Dabigatran Etexilate, 150 mg BID (Twice Daily)|Dosage used at study start
299655|NCT00157248|B1|Baseline|Dabigatran Etexilate, 150 mg QD (Once Daily)|Dosage used at study start
299656|NCT00157248|P4|Participant Flow|Dabigatran Etexilate, 300 mg BID (Twice Daily)|Dosage used at study start
299657|NCT00157248|P3|Participant Flow|Dabigatran Etexilate, 300 mg QD (Once Daily)|Dosage used at study start
299658|NCT00157248|P2|Participant Flow|Dabigatran Etexilate, 150 mg BID (Twice Daily)|Dosage used at study start
299659|NCT00157248|P1|Participant Flow|Dabigatran Etexilate, 150 mg QD (Once Daily)|Dosage used at study start
299660|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299661|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299662|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299663|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299664|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299665|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299666|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299667|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299668|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299669|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299670|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299671|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299672|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299673|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299674|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299675|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299676|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299677|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299678|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299679|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299680|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299681|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299682|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299683|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299684|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299685|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299691|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299692|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299693|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299694|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299695|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299696|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299697|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299698|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299699|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299706|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299707|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299708|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299709|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299710|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299711|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299712|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299713|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299714|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299715|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299716|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299717|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299718|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299719|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299720|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299721|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299722|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299723|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299724|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299725|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299726|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299727|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299728|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299729|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299730|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299731|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299732|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299733|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299734|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299735|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299736|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299737|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299738|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299739|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299740|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299741|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299742|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299743|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299744|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299745|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299746|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299747|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299748|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299749|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299750|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299751|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299752|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299753|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299754|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299755|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299756|NCT00157248|E6|Reported Event|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
299757|NCT00157248|E5|Reported Event|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
299758|NCT00157248|E4|Reported Event|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
299759|NCT00157248|E3|Reported Event|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
299760|NCT00157248|E2|Reported Event|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
299761|NCT00157248|E1|Reported Event|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
299762|NCT00157573|B1|Baseline|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.
In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
299763|NCT00157573|P2|Participant Flow|GM-CSF, Sargramostim Cohort 2|GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and the white blood cell count.
299764|NCT00157573|P1|Participant Flow|GM-CSF, Sargramostim Cohort 1|GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
299765|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.
In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
299766|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.
In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
299767|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.
In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
299768|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.
In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
300065|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
299769|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.
In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
299770|NCT00157573|E2|Reported Event|GM-CSF, Sargramostim Cohort 2|GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count.
299771|NCT00157573|E1|Reported Event|GM-CSF, Sargramostim Cohort 1|GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
299772|NCT00157755|B3|Baseline|Total|Total of all reporting groups
299773|NCT00157755|B2|Baseline|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
299774|NCT00157755|B1|Baseline|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
299775|NCT00157755|P6|Participant Flow|Idiopathic: Not Randomized|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. These subjects exited the study prior to randomization at 1.5 months.
299776|NCT00157755|P5|Participant Flow|Idiopathic: OFF First, Then ON|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
306211|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
299777|NCT00157755|P4|Participant Flow|Idiopathic: ON First, Then OFF|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
299778|NCT00157755|P3|Participant Flow|Diabetic: Not Randomized|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. These subjects exited the study prior to randomization at 1.5 months.
299779|NCT00157755|P2|Participant Flow|Diabetic: OFF First, Then ON|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
299780|NCT00157755|P1|Participant Flow|Diabetic: ON First, Then OFF|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
299781|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
299782|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
299783|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
299784|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
299785|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
299786|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
299787|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
299788|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
299789|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
299790|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
299791|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
299792|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
299793|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
299794|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
299795|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
299796|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
299797|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
299798|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
299799|NCT00157755|E2|Reported Event|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
299800|NCT00157755|E1|Reported Event|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
299801|NCT00157820|B4|Baseline|Total|Total of all reporting groups
299802|NCT00157820|B3|Baseline|DC True Then SC Sim|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm) then programmed as Single Chamber simulated"
299803|NCT00157820|B2|Baseline|SC Simulated Then DC True|Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
299804|NCT00157820|B1|Baseline|SC True|Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
299805|NCT00157820|P3|Participant Flow|DC True Then SC Sim|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm) then programmed as Single Chamber simulated"
300062|NCT00158925|P1|Participant Flow|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
299806|NCT00157820|P2|Participant Flow|SC Simulated Then DC True|Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
299807|NCT00157820|P1|Participant Flow|SC True|Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
299808|NCT00157820|O3|Outcome|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm)"
299809|NCT00157820|O2|Outcome|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
299810|NCT00157820|O1|Outcome|SC True|Allocated to Single Chamber ICD (SC true arm)
299811|NCT00157820|O3|Outcome|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm"
299812|NCT00157820|O2|Outcome|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
299813|NCT00157820|O1|Outcome|SC True|Allocated to Single Chamber ICD (SC true arm)
299814|NCT00157820|E3|Reported Event|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm)"
299815|NCT00157820|E2|Reported Event|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated
299816|NCT00157820|E1|Reported Event|SC True|Allocated to Single Chamber ICD (SC true arm)
299817|NCT00157950|B3|Baseline|Total|Total of all reporting groups
299818|NCT00157950|B2|Baseline|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
299819|NCT00157950|B1|Baseline|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
299820|NCT00157950|P2|Participant Flow|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
299821|NCT00157950|P1|Participant Flow|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
299822|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
299824|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
299825|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
299826|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
299827|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
299828|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
299829|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
299830|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
299831|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
299832|NCT00157950|E2|Reported Event|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
299833|NCT00157950|E1|Reported Event|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
299834|NCT00158054|B3|Baseline|Total|Total of all reporting groups
299835|NCT00158054|B2|Baseline|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
299836|NCT00158054|B1|Baseline|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
299837|NCT00158054|P2|Participant Flow|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
299838|NCT00158054|P1|Participant Flow|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
299839|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
299840|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
299841|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
299952|NCT00158743|P1|Participant Flow|Digoxin Immune Fab|"Digibind treatment plus standard of care
Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
299953|NCT00158743|O2|Outcome|Placebo|sodium chloride placebo
299842|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
299843|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
299844|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
299845|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
299887|NCT00158223|B1|Baseline|Placebo|Participants received encapsulated placebo made to match active drug
299888|NCT00158223|P2|Participant Flow|Pimozide|Participants received pimozide flexible dosing
306212|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
299846|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
299847|NCT00158054|E2|Reported Event|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
299848|NCT00158054|E1|Reported Event|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
299849|NCT00158184|B3|Baseline|Total|Total of all reporting groups
299850|NCT00158184|B2|Baseline|Rx Opioid Medical Users|Prescription Opioids users without abusive patterns of use.
299851|NCT00158184|B1|Baseline|Rx Opioid Abusers|Prescription Opioids users with abusive patterns of use.
299852|NCT00158184|P2|Participant Flow|Rx Opioid Non-Abusers|The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of participants with no history of opioid abuse.
299853|NCT00158184|P1|Participant Flow|Rx Opioid Abusers|The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of recreational prescription opioid (Rx) users.
299854|NCT00158184|O2|Outcome|Rx Opioid Non-Abusers|Medical users
299855|NCT00158184|O1|Outcome|Rx Opioid Abusers|Recreation users
299856|NCT00158184|O2|Outcome|Rx Opioid Non-Abusers|Medical prescription opioid users.
299857|NCT00158184|O1|Outcome|Rx Opioid Abusers|Recreational prescription opioid users.
299858|NCT00158184|E2|Reported Event|Rx Opioid Non-Abusers|
299859|NCT00158184|E1|Reported Event|Rx Opioid Abusers|
299860|NCT00158197|B5|Baseline|Total|Total of all reporting groups
299861|NCT00158197|B4|Baseline|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
299862|NCT00158197|B3|Baseline|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.
contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299863|NCT00158197|B2|Baseline|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299954|NCT00158743|O1|Outcome|Digoxin Immune Fab|"Digibind treatment plus standard of care
Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
299955|NCT00158743|E2|Reported Event|Placebo|sodium chloride placebo
300063|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
299864|NCT00158197|B1|Baseline|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299865|NCT00158197|P4|Participant Flow|Standard|Participants assigned to the standard condition did not receive vouchers for the provision of clean urines.
299875|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299889|NCT00158223|P1|Participant Flow|Placebo|Participants received encapsulated placebo made to match active drug
299866|NCT00158197|P3|Participant Flow|Intermittent Unpredictable Schedule|"Participants in the unpredictable intermittent condition earned vouchers of the same magnitude as those in the predictable intermittent condition and at approximately the same rate (i.e., $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second week of methamphetamine-negative urines, etc). More specifically, participants in this group received a voucher for $22.00 following their first three methamphetamine-negative urine tests. Following that they were eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. This date was randomly determined and they did not know in advance what day it was.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299867|NCT00158197|P2|Participant Flow|Continuous Schedule|"Those in the continuous condition received a voucher each time they tested negative for methamphetamine. The initial voucher value was $2.50. Each consecutive instance of abstinence increased the magnitude of the voucher by $1.50. Three consecutive abstinences resulted in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression could begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299868|NCT00158197|P1|Participant Flow|Intermittent Predictable Schedule|"Those in the intermittent predictable condition earned a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition received $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There were no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299869|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
299870|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299871|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299872|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299873|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
299915|NCT00158262|O1|Outcome|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
300219|NCT00152971|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
299874|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299886|NCT00158223|B2|Baseline|Pimozide|Participants received pimozide flexible dosing
306213|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
299876|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299877|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
299878|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299879|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299880|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
299881|NCT00158197|E4|Reported Event|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
299882|NCT00158197|E3|Reported Event|Intermittent Unpredictable Schedule|Those in the intermittent unpredictable condition will be eligible to receive a contingency management voucher on one day a week. Participants in this group will receive a voucher for $22.00 following their first 3 methamphetamine-negative urine tests. They will then be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. They will receive a voucher for $35.50 for the provision of their second set of 3 consecutive instances of methamphetamine-negative urine samples, $49.00 for their third set of 3 consecutive instances, and so forth. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test. All participants will provide observed urine samples M, W, & F for 12 wks and complete measures 1x/wk.
299916|NCT00158262|O2|Outcome|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
300220|NCT00152971|P3|Participant Flow|Enoxaparin|30mg bid (twice daily) subcutaneous
299883|NCT00158197|E2|Reported Event|Intermittent Predictable Schedule|Those in the intermittent predictable condition will earn a contingency management voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
299884|NCT00158197|E1|Reported Event|Continuous Voucher Schedule|Those in the continuous condition will receive a contingency management voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
299885|NCT00158223|B3|Baseline|Total|Total of all reporting groups
299897|NCT00158223|E1|Reported Event|Placebo|Participants received encapsulated placebo made to match active drug
299898|NCT00158249|B3|Baseline|Total|Total of all reporting groups
299899|NCT00158249|B2|Baseline|Citicoline|"2 gm/day
citicoline: 2 gm/day, 8 weeks treatment"
299900|NCT00158249|B1|Baseline|Placebo|"matched capsules
placebo: matched for physical appearance"
299901|NCT00158249|P2|Participant Flow|Citicoline|"2 gm/day
citicoline: 2 gm/day, 8 weeks treatment"
299902|NCT00158249|P1|Participant Flow|Placebo|"matched capsules
placebo: matched for physical appearance"
299903|NCT00158249|O2|Outcome|Citicoline|"2 gm/day
citicoline: 2 gm/day, 8 weeks treatment"
299904|NCT00158249|O1|Outcome|Placebo|"matched capsules
placebo: matched for physical appearance"
299905|NCT00158249|O2|Outcome|Citicoline|"2 gm/day
citicoline: 2 gm/day, 8 weeks treatment"
299906|NCT00158249|O1|Outcome|Placebo|"matched capsules
placebo: matched for physical appearance"
299907|NCT00158249|E2|Reported Event|Citicoline|"2 gm/day
citicoline: 2 gm/day, 8 weeks treatment"
299908|NCT00158249|E1|Reported Event|Placebo|"matched capsules
placebo: matched for physical appearance"
299909|NCT00158262|B3|Baseline|Total|Total of all reporting groups
299910|NCT00158262|B2|Baseline|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
299911|NCT00158262|B1|Baseline|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
299912|NCT00158262|P2|Participant Flow|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
299913|NCT00158262|P1|Participant Flow|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
299914|NCT00158262|O2|Outcome|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
299951|NCT00158743|P2|Participant Flow|Placebo|sodium chloride placebo
300061|NCT00158925|B1|Baseline|EASYTRAK EPI Lead|"Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.
EASYTRAK EPI lead: EASYTRAK EPI lead"
299917|NCT00158262|O1|Outcome|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
299918|NCT00158262|O2|Outcome|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
299919|NCT00158262|O1|Outcome|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
299920|NCT00158262|E2|Reported Event|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
299921|NCT00158262|E1|Reported Event|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
299922|NCT00158379|B1|Baseline|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
301526|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
299923|NCT00158379|P1|Participant Flow|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
299924|NCT00158379|O1|Outcome|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
299925|NCT00158379|O1|Outcome|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
299926|NCT00158379|E1|Reported Event|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
299927|NCT00158600|B3|Baseline|Total|Total of all reporting groups
299928|NCT00158600|B2|Baseline|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
299929|NCT00158600|B1|Baseline|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
299930|NCT00158600|P2|Participant Flow|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
299931|NCT00158600|P1|Participant Flow|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
299932|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
299933|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
299934|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
299935|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
299936|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
299937|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
299938|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
299939|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
299940|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
299941|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
299942|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
299943|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
299944|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
299945|NCT00158600|E3|Reported Event|Overall|
299946|NCT00158600|E2|Reported Event|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
299947|NCT00158600|E1|Reported Event|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
299948|NCT00158743|B3|Baseline|Total|Total of all reporting groups
299949|NCT00158743|B2|Baseline|Placebo|sodium chloride placebo
299950|NCT00158743|B1|Baseline|Digoxin Immune Fab|"Digibind treatment plus standard of care
Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
299956|NCT00158743|E1|Reported Event|Digoxin Immune Fab|"Digibind treatment plus standard of care
Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
299957|NCT00158756|B6|Baseline|Total|Total of all reporting groups
299958|NCT00158756|B5|Baseline|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
299959|NCT00158756|B4|Baseline|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299960|NCT00158756|B3|Baseline|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299961|NCT00158756|B2|Baseline|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299962|NCT00158756|B1|Baseline|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299963|NCT00158756|P5|Participant Flow|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
299964|NCT00158756|P4|Participant Flow|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299965|NCT00158756|P3|Participant Flow|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299966|NCT00158756|P2|Participant Flow|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
306214|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
299967|NCT00158756|P1|Participant Flow|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299968|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
299969|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299970|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299971|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299972|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299973|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
299974|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299975|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299976|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299977|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299978|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
299979|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299980|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299981|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299982|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299983|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
299984|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299985|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299986|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299987|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299988|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
299989|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299990|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299991|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299992|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300306|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
299993|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299994|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299995|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299996|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
299997|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
299998|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
299999|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300000|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300001|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300002|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
300003|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300004|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300005|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300006|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300007|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
300008|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300064|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
300009|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300010|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300011|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300012|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
300013|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300014|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300015|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300016|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300017|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
300018|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300019|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300020|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300021|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300022|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
300023|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300024|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300025|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300026|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300027|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300028|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300029|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300030|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300031|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
300032|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300033|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300034|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300221|NCT00152971|P2|Participant Flow|Dabigatran 150mg|qd (once daily) oral
300035|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300036|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
300037|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300038|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300039|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300040|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300041|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
300042|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300043|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300044|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300045|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300046|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
300047|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300048|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300049|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300050|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300051|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
300052|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300053|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300054|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300055|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300056|NCT00158756|E5|Reported Event|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
300057|NCT00158756|E4|Reported Event|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300058|NCT00158756|E3|Reported Event|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300059|NCT00158756|E2|Reported Event|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
300060|NCT00158756|E1|Reported Event|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
300222|NCT00152971|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
300066|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
300067|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
300068|NCT00158925|E1|Reported Event|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
300069|NCT00152516|B1|Baseline|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300070|NCT00152516|P1|Participant Flow|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300071|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300072|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300073|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300074|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300075|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300076|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300077|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300078|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300079|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300080|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300081|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300082|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300083|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300084|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300085|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300086|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300087|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300088|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300089|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300090|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300091|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300092|NCT00152516|E1|Reported Event|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
300093|NCT00152763|B5|Baseline|Total|Total of all reporting groups
300094|NCT00152763|B4|Baseline|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300095|NCT00152763|B3|Baseline|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300096|NCT00152763|B2|Baseline|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300097|NCT00152763|B1|Baseline|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300098|NCT00152763|P4|Participant Flow|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300099|NCT00152763|P3|Participant Flow|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300100|NCT00152763|P2|Participant Flow|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300101|NCT00152763|P1|Participant Flow|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300102|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet. These data are on men and women combined within CBT.
300257|NCT00153062|B1|Baseline|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
300258|NCT00153062|P4|Participant Flow|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
301527|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
300103|NCT00152763|O1|Outcome|Usual Cardiac Care|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This includes all men and women who received UCC.
300104|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300105|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300106|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300107|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300108|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300109|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300110|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300111|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300112|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300113|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300114|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300115|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300116|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300117|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300118|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300119|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300120|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300121|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300122|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
301528|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
300123|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300124|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300125|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300126|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300127|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300128|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300129|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300130|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300131|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300132|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300133|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300134|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300135|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300136|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300223|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
300224|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
300137|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300138|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300139|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300140|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300141|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300142|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300143|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300144|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300145|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300146|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300147|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300148|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300149|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300150|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300151|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300152|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300153|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300154|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300155|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300156|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300225|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
300226|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
300157|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300158|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300159|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300160|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300161|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300162|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300163|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300164|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300165|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300166|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300167|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300168|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300169|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300170|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300171|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300172|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300173|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300174|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300175|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300176|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300227|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
300228|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
300177|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300178|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300179|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300180|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300181|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300182|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300183|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300184|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300185|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300186|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300187|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300188|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300189|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300190|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300191|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300192|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300193|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300194|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300195|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300196|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300229|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
300230|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
300197|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300198|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300199|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300200|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300201|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300202|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300203|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300204|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300205|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300206|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300207|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300208|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300209|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300210|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300211|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300212|NCT00152763|E4|Reported Event|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
300213|NCT00152763|E3|Reported Event|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300214|NCT00152763|E2|Reported Event|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
300215|NCT00152763|E1|Reported Event|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
300216|NCT00152971|B4|Baseline|Total|Total of all reporting groups
300217|NCT00152971|B3|Baseline|Enoxaparin|30mg bid (twice daily) subcutaneous
300218|NCT00152971|B2|Baseline|Dabigatran 150mg|qd (once daily) oral
300235|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
300236|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
300237|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
300238|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
300239|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
300240|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
300241|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
300242|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
300243|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
300244|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
300245|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
300246|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
300247|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
300248|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
300249|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
300250|NCT00152971|E3|Reported Event|Enoxaparin|30mg bid (twice daily) subcutaneous
300251|NCT00152971|E2|Reported Event|Dabigatran 150mg|qd (once daily) oral
300252|NCT00152971|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
300253|NCT00153062|B5|Baseline|Total|Total of all reporting groups
300254|NCT00153062|B4|Baseline|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
300255|NCT00153062|B3|Baseline|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
300256|NCT00153062|B2|Baseline|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
300259|NCT00153062|P3|Participant Flow|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
300260|NCT00153062|P2|Participant Flow|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
300261|NCT00153062|P1|Participant Flow|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
300262|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
300263|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
300264|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
300265|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
300266|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
300267|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
300268|NCT00153062|O2|Outcome|Clopidogrel|Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
300269|NCT00153062|O1|Outcome|Aspirin + Extended Release Dipyridamole|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
300270|NCT00153062|O2|Outcome|Clopidogrel|Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
300271|NCT00153062|O1|Outcome|Aspirin + Extended Release Dipyridamole|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
300272|NCT00153062|E4|Reported Event|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
300273|NCT00153062|E3|Reported Event|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
300274|NCT00153062|E2|Reported Event|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
300275|NCT00153062|E1|Reported Event|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
300276|NCT00153101|B6|Baseline|Total|Total of all reporting groups
300277|NCT00153101|B5|Baseline|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300278|NCT00153101|B4|Baseline|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300279|NCT00153101|B3|Baseline|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300280|NCT00153101|B2|Baseline|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300281|NCT00153101|B1|Baseline|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300282|NCT00153101|P5|Participant Flow|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300283|NCT00153101|P4|Participant Flow|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300284|NCT00153101|P3|Participant Flow|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300285|NCT00153101|P2|Participant Flow|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300286|NCT00153101|P1|Participant Flow|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300287|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300288|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300289|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300290|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300291|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300292|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300293|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300294|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300295|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300296|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300297|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300298|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300299|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300300|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300301|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300302|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300303|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300304|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300305|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300307|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300308|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300309|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300310|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300311|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300312|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300313|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300314|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300315|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300316|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300317|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300318|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300319|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300320|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300321|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300322|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300323|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300324|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300325|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300326|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300327|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300328|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300329|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300330|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300331|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300332|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300333|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300334|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300427|NCT00159419|E1|Reported Event|Pamidronate Treatment|Acute phase reaction with infusion
300335|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300336|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300337|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300338|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300339|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300340|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300341|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300342|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300343|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300344|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300345|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300346|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300347|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300348|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300349|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
306215|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
300350|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300351|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300352|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300353|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300354|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300355|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300356|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300357|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300358|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300359|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300360|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300361|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300362|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300363|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300364|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300365|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300366|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300367|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300368|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300369|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300370|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300371|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300372|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300373|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300374|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300375|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
301138|NCT00162136|O2|Outcome|Grade 3/4|Grade 3=Severe, Grade 4=Life-threatening or disabling
300376|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300377|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300378|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300379|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300380|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300381|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300382|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300383|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300384|NCT00153101|E5|Reported Event|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
300385|NCT00153101|E4|Reported Event|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
300386|NCT00153101|E3|Reported Event|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
300387|NCT00153101|E2|Reported Event|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
300388|NCT00153101|E1|Reported Event|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
300389|NCT00153166|B4|Baseline|Total|Total of all reporting groups
300390|NCT00153166|B3|Baseline|PAD Without Diabetes|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
306216|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
300391|NCT00153166|B2|Baseline|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
300392|NCT00153166|B1|Baseline|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
300393|NCT00153166|P3|Participant Flow|PAD (Excluding Patients With Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Excluding those patients with diabetes. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
300394|NCT00153166|P2|Participant Flow|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
300395|NCT00153166|P1|Participant Flow|Healthy Controls|Healthy individuals, non-smokers, normal CV examination. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
300396|NCT00153166|O3|Outcome|PAD (Excluding Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
300397|NCT00153166|O2|Outcome|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
300398|NCT00153166|O1|Outcome|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
300399|NCT00153166|O3|Outcome|PAD (Excluding Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
300400|NCT00153166|O2|Outcome|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
300401|NCT00153166|O1|Outcome|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
300402|NCT00153166|E4|Reported Event|Received Placebo/Placebo|Including healthy subjects and subjects with PAD
300403|NCT00153166|E3|Reported Event|Received Placebo/Pioglitazone|Including healthy subjects and subjects with PAD
300404|NCT00153166|E2|Reported Event|Received Atorvastatin/Placebo|Including healthy subjects and subjects with PAD
300405|NCT00153166|E1|Reported Event|Received Atorvastatin/Pioglitazone|Including healthy subjects and subjects with PAD
300406|NCT00153179|B3|Baseline|Total|Total of all reporting groups
300407|NCT00153179|B2|Baseline|Metabolic Syndrome|
300408|NCT00153179|B1|Baseline|Healthy Controls|
300409|NCT00153179|P4|Participant Flow|Metabolic Syndrome, Acipimox First, Then Placebo|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
300410|NCT00153179|P3|Participant Flow|Metabolic Syndrome, Placebo First, Then Acipimox|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
300411|NCT00153179|P2|Participant Flow|Healthy Controls, Acipimox First, Then Placebo|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
300412|NCT00153179|P1|Participant Flow|Healthy Controls, Placebo First, Then Acipimox|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
300413|NCT00153179|O4|Outcome|Metabolic Syndrome, Acipimox Treatment|
300414|NCT00153179|O3|Outcome|Metabolic Syndrome, Placebo Treatment|
300428|NCT00159432|B1|Baseline|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
300429|NCT00159432|P1|Participant Flow|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
300430|NCT00159432|O1|Outcome|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
300431|NCT00159432|O1|Outcome|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
300432|NCT00159432|E1|Reported Event|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
300433|NCT00159822|B1|Baseline|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300434|NCT00159822|P1|Participant Flow|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300501|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
301529|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
300435|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300436|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300437|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300438|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300439|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300440|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300441|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300442|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300547|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300443|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300444|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300445|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300470|NCT00159861|E2|Reported Event|Sildenafil/Sildenafil|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300446|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300447|NCT00159822|E1|Reported Event|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
300448|NCT00159861|B3|Baseline|Total|Total of all reporting groups
300449|NCT00159861|B2|Baseline|Sildenafil/Sildenafil|Study A1481141: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300450|NCT00159861|B1|Baseline|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300451|NCT00159861|P2|Participant Flow|Sildenafil: Core Study / Sildenafil: Extension Study|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300452|NCT00159861|P1|Participant Flow|Placebo: Core Study / Sildenafil: Extension Study|Core Study: Placebo (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration); Extension Study: Sildenafil (until last enrolled subject completed 3 years of treatment) - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300453|NCT00159861|O2|Outcome|Sldenafil/Sildenafil|Core Study A1481141: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300454|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study A1481141: Placebo TID (3 times daily); Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300455|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300456|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300457|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300458|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300459|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300460|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300461|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300462|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300548|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300463|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300464|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300465|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300466|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300467|NCT00159861|O1|Outcome|All Subjects|Core Study A1481141: Placebo or Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator.
300468|NCT00159861|O1|Outcome|All Subjects|Core Study A1481141: Placebo or Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300469|NCT00159861|E3|Reported Event|Placebo/Discontinued|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Discontinued
300471|NCT00159861|E1|Reported Event|Placebo/Sildenafil|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
300472|NCT00159874|B8|Baseline|Total|Total of all reporting groups
300473|NCT00159874|B7|Baseline|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300474|NCT00159874|B6|Baseline|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300475|NCT00159874|B5|Baseline|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300476|NCT00159874|B4|Baseline|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300477|NCT00159874|B3|Baseline|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300478|NCT00159874|B2|Baseline|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300479|NCT00159874|B1|Baseline|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300480|NCT00159874|P7|Participant Flow|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300481|NCT00159874|P6|Participant Flow|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300482|NCT00159874|P5|Participant Flow|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300483|NCT00159874|P4|Participant Flow|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300484|NCT00159874|P3|Participant Flow|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300485|NCT00159874|P2|Participant Flow|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300486|NCT00159874|P1|Participant Flow|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300487|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300488|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300489|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300490|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300549|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300491|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300492|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300493|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300494|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300495|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300496|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300497|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300498|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300499|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300500|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300502|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300503|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300504|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300505|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300506|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300507|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300508|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300509|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300510|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300511|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300512|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300513|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300514|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300515|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300516|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300517|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300518|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300519|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300520|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
301139|NCT00162136|O1|Outcome|Grade 1/2|Grade 1=Mild, Grade 2=Moderate
300521|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300522|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300523|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300524|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300525|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300526|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300527|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300528|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300529|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300530|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300531|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300532|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300533|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300534|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300535|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300536|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300537|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300538|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300539|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300540|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300541|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300542|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300543|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300544|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300545|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300546|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300933|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300550|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300551|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300552|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300553|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300554|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300555|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300556|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300557|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300558|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300559|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300560|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300561|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300562|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
301530|NCT00165698|E2|Reported Event|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
300563|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300564|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300565|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300566|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300567|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300568|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300569|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300570|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300571|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300572|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300573|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300574|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300575|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300576|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300577|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300578|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300579|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300580|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300581|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300582|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300583|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300584|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300585|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300586|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300587|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300588|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300589|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300590|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300591|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300592|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300593|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300594|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300595|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300596|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300597|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300598|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300599|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300600|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300601|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300602|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300603|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300604|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300605|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300606|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300607|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300608|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300609|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300610|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300611|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300612|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300613|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300614|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300615|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300616|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300617|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300618|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300619|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300620|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
300621|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300622|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300623|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300624|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300625|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300626|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300627|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300628|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
301531|NCT00165698|E1|Reported Event|Menatetrenone|15 mg t.i.d. orally for 12 months
300629|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300630|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300631|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300632|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300633|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300634|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300635|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300636|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300637|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300638|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300639|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300640|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300641|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300642|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300643|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
300644|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
300645|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
300646|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
300647|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
300648|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
300649|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
300650|NCT00159874|E3|Reported Event|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
300651|NCT00159874|E2|Reported Event|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
301140|NCT00162136|O6|Outcome|45 mg/m2|Ixabepilone
300652|NCT00159874|E1|Reported Event|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
300653|NCT00159913|B5|Baseline|Total|Total of all reporting groups
300654|NCT00159913|B4|Baseline|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300655|NCT00159913|B3|Baseline|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300656|NCT00159913|B2|Baseline|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300657|NCT00159913|B1|Baseline|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300658|NCT00159913|P4|Participant Flow|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300659|NCT00159913|P3|Participant Flow|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300660|NCT00159913|P2|Participant Flow|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300692|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300693|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300891|NCT00160563|O3|Outcome|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
300661|NCT00159913|P1|Participant Flow|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300662|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300663|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300664|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300665|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300666|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300667|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300668|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300669|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300670|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300671|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300672|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300673|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300674|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300675|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300676|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300677|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300678|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300679|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300680|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300681|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300682|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300683|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
301141|NCT00162136|O5|Outcome|40 mg/m2|Ixabepilone
300684|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300685|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300686|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300687|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300688|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300689|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300690|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300691|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300694|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300695|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300696|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300697|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300698|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300699|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300700|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300701|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300702|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300703|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300704|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300705|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300706|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300707|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300708|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300709|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300710|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300711|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300712|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300713|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300714|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300715|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300934|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300716|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300717|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300718|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300719|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300720|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300721|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300722|NCT00159913|E5|Reported Event|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
300723|NCT00159913|E4|Reported Event|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
300724|NCT00159913|E3|Reported Event|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300725|NCT00159913|E2|Reported Event|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
300726|NCT00159913|E1|Reported Event|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.
Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
300727|NCT00159965|B3|Baseline|Total|Total of all reporting groups
300728|NCT00159965|B2|Baseline|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300729|NCT00159965|B1|Baseline|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300730|NCT00159965|P2|Participant Flow|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300731|NCT00159965|P1|Participant Flow|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300732|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300733|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300734|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300735|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300736|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300737|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300738|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300739|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300740|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300741|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300742|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300743|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300744|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300745|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300746|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300747|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300748|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300749|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300750|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300935|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300751|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300752|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300753|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300754|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300755|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300756|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300757|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300758|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300759|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300760|NCT00159965|E2|Reported Event|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300761|NCT00159965|E1|Reported Event|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
300762|NCT00160199|B3|Baseline|Total|Total of all reporting groups
300763|NCT00160199|B2|Baseline|Prometrium 400 mg/Day|
300784|NCT00160251|B6|Baseline|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300785|NCT00160251|B5|Baseline|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300786|NCT00160251|B4|Baseline|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300787|NCT00160251|B3|Baseline|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300788|NCT00160251|B2|Baseline|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300789|NCT00160251|B1|Baseline|Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400|"Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period."
300790|NCT00160251|P8|Participant Flow|Arm 8: PEG + RBV + BOC 800|By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
300791|NCT00160251|P7|Participant Flow|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300792|NCT00160251|P6|Participant Flow|ARM 4+6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300793|NCT00160251|P5|Participant Flow|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300794|NCT00160251|P4|Participant Flow|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300795|NCT00160251|P3|Participant Flow|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300796|NCT00160251|P2|Participant Flow|Arm 1B: PEG + RBV + BOC|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300797|NCT00160251|P1|Participant Flow|Arm 1A: PEG + RBV|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300798|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300799|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300800|NCT00160251|O4|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300801|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300802|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300803|NCT00160251|O1|Outcome|Arm 1B: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300804|NCT00160251|O8|Outcome|Missing Data|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
300805|NCT00160251|O7|Outcome|Log Drop ≥5|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
300806|NCT00160251|O6|Outcome|Log Drop 4 to <5|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
300807|NCT00160251|O5|Outcome|Log Drop 3 to <4|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
300808|NCT00160251|O4|Outcome|Log Drop 2 to <3|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
300809|NCT00160251|O3|Outcome|Log Drop 1 to <2|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
301532|NCT00165776|B5|Baseline|Total|Total of all reporting groups
300810|NCT00160251|O2|Outcome|Log Drop 0 to <1|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
300811|NCT00160251|O1|Outcome|Log Drop <0|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
300812|NCT00160251|O5|Outcome|Log Drop ≥5|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
300813|NCT00160251|O4|Outcome|Log Drop 4 to <5|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
300814|NCT00160251|O3|Outcome|Log Drop 3 to <4|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
300815|NCT00160251|O2|Outcome|Log Drop 2 to <3|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
300816|NCT00160251|O1|Outcome|Log Drop 1 to <2|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
300817|NCT00160251|O6|Outcome|Log Drop ≥5|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
300818|NCT00160251|O5|Outcome|Log Drop 4 to <5|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
300819|NCT00160251|O4|Outcome|Log Drop 3 to <4|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
300936|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
301142|NCT00162136|O4|Outcome|35 mg/m2|Ixabepilone
300820|NCT00160251|O3|Outcome|Log Drop 2 to <3|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
300821|NCT00160251|O2|Outcome|Log Drop 1 to <2|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
300822|NCT00160251|O1|Outcome|Log Drop 0 to <1|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
300823|NCT00160251|O8|Outcome|Arm 8: PEG + RBV + BOC 800|By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
300824|NCT00160251|O7|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300825|NCT00160251|O6|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300826|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300827|NCT00160251|O4|Outcome|Arm 3: PEG + BOC 200|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300828|NCT00160251|O3|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300829|NCT00160251|O2|Outcome|Arm 1B: PEG + RBV + BOC 400|Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300830|NCT00160251|O1|Outcome|Arm 1A: PEG + RBV|Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
300831|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300832|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300833|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300834|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300835|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300836|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300837|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300838|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300839|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300840|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300841|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300842|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300843|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300844|NCT00160251|O5|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300845|NCT00160251|O4|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300846|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300847|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300848|NCT00160251|O1|Outcome|Arm 1A: PEG + RBV and Arm 1B: PEG + RBV + BOC 400|"Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period."
300849|NCT00160251|O3|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300850|NCT00160251|O2|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300851|NCT00160251|O1|Outcome|Arms 2, 3, 4, 6: PEG + BOC 100, 200, or 400|A single dose of PEG was given first, followed 1 week later by PEG + BOC. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300852|NCT00160251|O4|Outcome|>12 to 36 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 12 to 36.
300853|NCT00160251|O3|Outcome|>8 to 12 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 8 to 12.
300854|NCT00160251|O2|Outcome|>4 to 8 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 4 to 8.
300855|NCT00160251|O1|Outcome|0 to ≤ 4 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA within the first 4 weeks of treatment.
300856|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300857|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300858|NCT00160251|O4|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300859|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300860|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300861|NCT00160251|O1|Outcome|Arm 1B: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300862|NCT00160251|E8|Reported Event|PEG + RBV + BOC 800|Arm 8: By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
300863|NCT00160251|E7|Reported Event|PEG + BOC 800 (24 Weeks)|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300864|NCT00160251|E6|Reported Event|PEG + BOC 400 (24 + 48 Weeks)|Arms 4 + 6: A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300865|NCT00160251|E5|Reported Event|PEG + RBV + BOC 400 (48 Weeks)|Arm 5: A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300866|NCT00160251|E4|Reported Event|PEG + BOC 200 (48 Weeks)|Arm 3: A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300867|NCT00160251|E3|Reported Event|PEG + BOC 100 (48 Weeks)|Arm 2: A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300868|NCT00160251|E2|Reported Event|PEG + RBV + BOC 400 (24 Weeks)|Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
300869|NCT00160251|E1|Reported Event|PEG + RBV|Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
300870|NCT00160524|B1|Baseline|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
300871|NCT00160524|P1|Participant Flow|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
300872|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
300937|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300873|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
300874|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
300875|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
300876|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
300877|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
300878|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
300879|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
300880|NCT00160524|E1|Reported Event|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
300881|NCT00160563|B4|Baseline|Total|Total of all reporting groups
300882|NCT00160563|B3|Baseline|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
300883|NCT00160563|B2|Baseline|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
300884|NCT00160563|B1|Baseline|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
300885|NCT00160563|P3|Participant Flow|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
300886|NCT00160563|P2|Participant Flow|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
300887|NCT00160563|P1|Participant Flow|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
300888|NCT00160563|O3|Outcome|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
300889|NCT00160563|O2|Outcome|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
300890|NCT00160563|O1|Outcome|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
300892|NCT00160563|O2|Outcome|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
300893|NCT00160563|O1|Outcome|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
300894|NCT00160563|E4|Reported Event|PLC-LCTZ|Levocetirizine after having been randomized to Placebo in the preceding A00309 trial (PLC-LCTZ) erroneously (Patient 016/1709)
300895|NCT00160563|E3|Reported Event|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
300896|NCT00160563|E2|Reported Event|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
300897|NCT00160563|E1|Reported Event|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
300898|NCT00160641|B1|Baseline|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300899|NCT00160641|P1|Participant Flow|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300900|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300901|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300938|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300939|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300902|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300903|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300904|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300905|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300906|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300907|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300908|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
301079|NCT00162123|B8|Baseline|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
301114|NCT00162123|E8|Reported Event|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
300909|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300910|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300911|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300912|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300913|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300914|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300915|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300916|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300917|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300918|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300919|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300920|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300921|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300922|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300923|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300924|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300925|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300926|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300927|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300928|NCT00160641|E1|Reported Event|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
300929|NCT00160693|B1|Baseline|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300930|NCT00160693|P1|Participant Flow|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300931|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300932|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300940|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300941|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300942|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300943|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300944|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300945|NCT00160693|E1|Reported Event|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
300946|NCT00160706|B1|Baseline|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
300947|NCT00160706|P1|Participant Flow|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
300948|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
300949|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
300950|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
300951|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
300952|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
301418|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
300953|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
300954|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
300955|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
300956|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
300957|NCT00160706|E1|Reported Event|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study."
300958|NCT00161213|B1|Baseline|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.
gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
300959|NCT00161213|P1|Participant Flow|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.
gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
300960|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.
gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
300961|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.
gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
300962|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.
gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
300963|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.
gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
300964|NCT00161213|E1|Reported Event|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.
gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
300965|NCT00161382|B3|Baseline|Total|Total of all reporting groups
300966|NCT00161382|B2|Baseline|Control Group|No intervention: Control curriculum consists of standard sexual education.
300967|NCT00161382|B1|Baseline|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum
HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
300968|NCT00161382|P2|Participant Flow|Control Group|No intervention: Control curriculum consists of standard sexual education.
300969|NCT00161382|P1|Participant Flow|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum
HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
300970|NCT00161382|O2|Outcome|Control Group|No intervention: Control curriculum consists of standard sexual education.
300971|NCT00161382|O1|Outcome|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum
HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
300972|NCT00161382|E2|Reported Event|Control Group|No intervention: Control curriculum consists of standard sexual education.
301012|NCT00162097|B4|Baseline|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301769|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
300973|NCT00161382|E1|Reported Event|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum
HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
300974|NCT00161473|B3|Baseline|Total|Total of all reporting groups
300975|NCT00161473|B2|Baseline|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
300976|NCT00161473|B1|Baseline|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
300977|NCT00161473|P2|Participant Flow|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
300978|NCT00161473|P1|Participant Flow|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
300979|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
300980|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
300981|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
300982|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
300983|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
300984|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
300985|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
300986|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
300987|NCT00161473|E2|Reported Event|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
300988|NCT00161473|E1|Reported Event|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
300989|NCT00161616|B3|Baseline|Total|Total of all reporting groups
300990|NCT00161616|B2|Baseline|Standard of Care|Standard of Care: Surgical fixation only
300991|NCT00161616|B1|Baseline|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
300992|NCT00161616|P2|Participant Flow|Standard of Care|Standard of Care: Surgical fixation only
301143|NCT00162136|O3|Outcome|30 mg/m2|Ixabepilone
300993|NCT00161616|P1|Participant Flow|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
300994|NCT00161616|O2|Outcome|Standard of Care|Standard of Care: Surgical fixation only
300995|NCT00161616|O1|Outcome|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
300996|NCT00161616|O2|Outcome|Standard of Care|Standard of Care: Surgical fixation only
300997|NCT00161616|O1|Outcome|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
300998|NCT00161616|E2|Reported Event|Standard of Care|Standard of Care: Surgical fixation only
300999|NCT00161616|E1|Reported Event|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
301000|NCT00162032|B3|Baseline|Total|Total of all reporting groups
301001|NCT00162032|B2|Baseline|Adolescents (Ages 12-16)|Arm B children 12-16 years of age
301002|NCT00162032|B1|Baseline|Children (Ages 4-11)|Arm A children 4-11 years of age
301003|NCT00162032|P2|Participant Flow|Adolescents (Ages 12-16)|Arm B children 12-16 years of age
301004|NCT00162032|P1|Participant Flow|Children (Ages 4-11)|Arm A children 4-11 years of age
301005|NCT00162032|O4|Outcome|Adolescents (12-16 Years) Abnormal|sss (summed stress score >4, high risk
301006|NCT00162032|O3|Outcome|Children (4-11 Years) Abnormal|SSS (summed stress score)>4, high risk
301007|NCT00162032|O2|Outcome|Adolescents (12-16 Years) Normal|SSS (summed stress score) <4, low risk
301008|NCT00162032|O1|Outcome|Children (4 -11 Years) Normal|SSS (summed stress score) <=4, low risk
301009|NCT00162032|E2|Reported Event|Adolescents (Ages 12-16)|Arm B adolescents 12-16 years of age
301010|NCT00162032|E1|Reported Event|Children (Ages 4-11)|Arm A children 4-11 years of age
301011|NCT00162097|B5|Baseline|Total|Total of all reporting groups
301073|NCT00162097|E5|Reported Event|Not Dosed|
301013|NCT00162097|B3|Baseline|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301014|NCT00162097|B2|Baseline|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301015|NCT00162097|B1|Baseline|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301016|NCT00162097|P4|Participant Flow|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301017|NCT00162097|P3|Participant Flow|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301018|NCT00162097|P2|Participant Flow|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301088|NCT00162123|P7|Participant Flow|Extended Maintenance Only: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301144|NCT00162136|O2|Outcome|20 mg/m2|Ixabepilone
301145|NCT00162136|O1|Outcome|10 mg/m2|Ixabepilone
301019|NCT00162097|P1|Participant Flow|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301020|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301021|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301022|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301023|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301074|NCT00162097|E4|Reported Event|EFV600mg Participants With Normal Hepatic Function|
301075|NCT00162097|E3|Reported Event|EFV600mg Participants With Severe Hepatic Impairment|
301076|NCT00162097|E2|Reported Event|EFV600mg Participants With Moderate Hepatic Impairment|
301077|NCT00162097|E1|Reported Event|EFV600mg Participants With Mild Hepatic Impairment|
301024|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301025|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301026|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301027|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301028|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301029|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301030|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301089|NCT00162123|P6|Participant Flow|Extended Maintenance Only: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301031|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301032|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301033|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301034|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301035|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301036|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301037|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301038|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301039|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301040|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301041|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301042|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301090|NCT00162123|P5|Participant Flow|Extended Maintenance Only: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301043|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301044|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301045|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301046|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301047|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301048|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301049|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301050|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301051|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301052|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301053|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301054|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301091|NCT00162123|P4|Participant Flow|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
301146|NCT00162136|E6|Reported Event|Ixa 45 mg/m2|
301147|NCT00162136|E5|Reported Event|Ixa 40 mg/m2|
301148|NCT00162136|E4|Reported Event|Ixa 35 mg/m2|
301055|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301056|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301057|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301058|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301059|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301060|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301061|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301062|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301063|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301064|NCT00162097|O5|Outcome|Participants Not Dosed|Participants were enrolled in the study and discontinued prior to study drug administration
301065|NCT00162097|O4|Outcome|Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301066|NCT00162097|O3|Outcome|Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301067|NCT00162097|O2|Outcome|Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301126|NCT00162136|B3|Baseline|30 mg/m2|Ixabepilone
301127|NCT00162136|B2|Baseline|20 mg/m2|Ixabepilone
301128|NCT00162136|B1|Baseline|10 mg/m2|Ixabepilone
301149|NCT00162136|E3|Reported Event|Ixa 30 mg/m2|
301068|NCT00162097|O1|Outcome|Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301069|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
301070|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
301071|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
301072|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
301080|NCT00162123|B7|Baseline|Extended Maintenance: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301081|NCT00162123|B6|Baseline|Extended Maintenance: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301082|NCT00162123|B5|Baseline|Extended Maintenance: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301083|NCT00162123|B4|Baseline|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
301084|NCT00162123|B3|Baseline|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301085|NCT00162123|B2|Baseline|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301086|NCT00162123|B1|Baseline|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301087|NCT00162123|P8|Participant Flow|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
301129|NCT00162136|P1|Participant Flow|Ixabepilone|Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
301130|NCT00162136|O1|Outcome|All Treated Participants|
301131|NCT00162136|O1|Outcome|Treated Subjects|All treated subjects with measurement at timepoint
301092|NCT00162123|P3|Participant Flow|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301093|NCT00162123|P2|Participant Flow|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301094|NCT00162123|P1|Participant Flow|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301095|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301096|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301097|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301098|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301099|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301100|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301101|NCT00162123|O7|Outcome|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
301102|NCT00162123|O6|Outcome|Extended Maintenance: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301103|NCT00162123|O5|Outcome|Extended Maintenance: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301104|NCT00162123|O4|Outcome|Extended Maintenance: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301105|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 0.3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301106|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301132|NCT00162136|O5|Outcome|Grade 4|Life-threatening or disabling
301107|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301108|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301109|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301110|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301111|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301112|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301113|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301115|NCT00162123|E7|Reported Event|Extended Maintenance Only: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301116|NCT00162123|E6|Reported Event|Extended Maintenance Only: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301117|NCT00162123|E5|Reported Event|Extended Maintenance Only: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
301118|NCT00162123|E4|Reported Event|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
301119|NCT00162123|E3|Reported Event|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301120|NCT00162123|E2|Reported Event|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301121|NCT00162123|E1|Reported Event|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
301122|NCT00162136|B7|Baseline|Total|Total of all reporting groups
301123|NCT00162136|B6|Baseline|45 mg/m2|Ixabepilone
301124|NCT00162136|B5|Baseline|40 mg/m2|Ixabepilone
301125|NCT00162136|B4|Baseline|35 mg/m2|Ixabepilone
301153|NCT00162266|B3|Baseline|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301154|NCT00162266|B2|Baseline|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301155|NCT00162266|B1|Baseline|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301156|NCT00162266|P4|Participant Flow|Open-Label (OL) Abatacept (10 mg / kg)|Following a 5-month interim (where the placebo group was split into 2mg/kg abatacept or placebo and participants in 2 original abatacept continued at same dose), participants who enrolled in OL period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
301157|NCT00162266|P3|Participant Flow|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301158|NCT00162266|P2|Participant Flow|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301159|NCT00162266|P1|Participant Flow|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301419|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301160|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301161|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301162|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301163|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301164|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301165|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301166|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301167|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DBperiod received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately weight-tiered dose of abatacept 10 mg/kg.
301168|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301169|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301398|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301170|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301171|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301172|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301173|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301174|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301175|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301176|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301177|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301178|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301179|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301199|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301942|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
301180|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg /kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301181|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301182|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301183|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301184|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301185|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301186|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301187|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301188|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301189|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301488|NCT00165646|P2|Participant Flow|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
301190|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301191|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301192|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301193|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301194|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301195|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301196|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301197|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301198|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301420|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301200|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301201|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301202|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301203|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301204|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301205|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301206|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301207|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301208|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301209|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301230|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301489|NCT00165646|P1|Participant Flow|Placebo|once daily orally for 4 weeks
301210|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301211|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the double-blind period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301212|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301213|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301214|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301215|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301216|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301217|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301218|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301239|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301943|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
301219|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301220|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301221|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301222|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301223|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301224|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301225|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301226|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301227|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301228|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301229|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by I) infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g.
301399|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301231|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg /kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301232|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301233|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g.
301234|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
301235|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
301236|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301237|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301238|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by intravenous IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301421|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301240|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301241|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301242|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301243|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301244|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301245|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an on OL weight-tiered dose of abatacept 10 mg/kg.
301246|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301247|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301248|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301249|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301250|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
328504|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
301251|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301252|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301253|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the DBperiod received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301254|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301255|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301256|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301257|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301343|NCT00162266|O3|Outcome|DB Placebo + Methotrexate|Participants in the DB study received a placebo administered monthly IV plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate(maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301258|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301259|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301260|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301261|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301262|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301263|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301264|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301265|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301400|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301691|NCT00166036|B2|Baseline|Pravastatin 80 mg|Subject treated with oral Pravastatin 80 mg for 12 Weeks.
301266|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301267|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301268|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301269|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301270|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301522|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
301271|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301272|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301273|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301274|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301275|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301276|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301277|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301278|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301279|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301280|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
328505|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
301281|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301282|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301283|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301284|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301285|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
301286|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301415|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301287|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301288|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301289|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301290|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301291|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301292|NCT00162266|O4|Outcome|Open-Label (OL) Abatacept (10 mg / kg)|Following a 5-month interim (where the placebo group was split into 2mg/kg abatacept or placebo and participants in 2 original abatacept continued at same dose), participants who enrolled in OL period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
301293|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301294|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301295|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301296|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301297|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301298|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301299|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301300|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301416|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301301|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301302|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301303|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301304|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301305|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
301306|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
301307|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301308|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301309|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
301310|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301311|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301325|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301312|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301313|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301314|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301315|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
306217|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
301316|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301317|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301318|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301319|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301320|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301321|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301322|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301323|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301324|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301370|NCT00156533|E4|Reported Event|CTRL|Monitor only condition.
301371|NCT00156533|E3|Reported Event|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
301372|NCT00156533|E2|Reported Event|QHS Zolpidem|QHS dosing with 10mg of zolpidem
301373|NCT00156533|E1|Reported Event|Placebo|QHS dosing with placebo
301326|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301327|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301328|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301329|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301330|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301331|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301332|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301333|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301334|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301335|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301336|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301337|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301338|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301396|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301397|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
328506|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
301339|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301340|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301341|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301342|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301344|NCT00162266|O2|Outcome|DB Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered monthly IV plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301345|NCT00162266|O1|Outcome|DB Abatacept 10 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept administered monthly IV plus methotrexateParticipants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301346|NCT00162266|O3|Outcome|DB Placebo + Methotrexate|Participants in the DB study received a placebo that was administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate(maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period.
301347|NCT00162266|O2|Outcome|DB Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period.
301348|NCT00162266|O1|Outcome|DB Abatacept 10 mg/kg + Methotrexate|Participants received a weight-tiered dose of 10 mg/kg of abatacept, administered intravenously(IV) monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
301349|NCT00162266|E4|Reported Event|Placebo+MTX|
301350|NCT00162266|E3|Reported Event|Abatacept (LT)|
301351|NCT00162266|E2|Reported Event|Aba 2mg/kg+MTX|
301352|NCT00162266|E1|Reported Event|Aba 10mg/kg+MTX|
301353|NCT00156533|B5|Baseline|Total|Total of all reporting groups
301354|NCT00156533|B4|Baseline|CTRL|Monitor only condition.
301355|NCT00156533|B3|Baseline|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
301356|NCT00156533|B2|Baseline|QHS Zolpidem|QHS dosing with 10mg of zolpidem
301357|NCT00156533|B1|Baseline|Placebo|QHS dosing with placebo
301358|NCT00156533|P4|Participant Flow|CTRL|Monitor only condition.
301359|NCT00156533|P3|Participant Flow|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
301360|NCT00156533|P2|Participant Flow|QHS (Nightly) Zolpidem|Once nightly (QHS) dosing with 10mg of zolpidem
301361|NCT00156533|P1|Participant Flow|Placebo|Once nightly dosing (quaque hora somni [QHS])with placebo
301362|NCT00156533|O4|Outcome|CTRL|Monitor only condition.
301363|NCT00156533|O3|Outcome|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
301364|NCT00156533|O2|Outcome|QHS Zolpidem|QHS (i.e., nightly) dosing with 10mg of zolpidem
301365|NCT00156533|O1|Outcome|Placebo|QHS (i.e., nightly) dosing with placebo
301366|NCT00156533|O4|Outcome|CTRL|Monitor only condition (no placebo and no zolpidem).
301367|NCT00156533|O3|Outcome|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)
301368|NCT00156533|O2|Outcome|QHS Zolpidem|QHS (i.e., nightly) dosing with 10mg of zolpidem
301369|NCT00156533|O1|Outcome|Placebo|QHS (i.e., nightly) dosing with placebo
301374|NCT00156715|B1|Baseline|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
301375|NCT00156715|P1|Participant Flow|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
301376|NCT00156715|O1|Outcome|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
301377|NCT00156715|O1|Outcome|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
301417|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301523|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
301378|NCT00156715|E1|Reported Event|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
301379|NCT00162370|B1|Baseline|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.
Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
301380|NCT00162370|P1|Participant Flow|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.
Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
301381|NCT00162370|O1|Outcome|Definity|"All patients will undergo a gray scale baseline unenhanced imaging session (apical 2- or 4 chamber view), as well as a DEFINITY (Perflutren Lipid Microsphere Injectable Suspension)-enhanced rest and a DEFINITY enhanced exercise or dobutamine stress echocardiography imaging session. The unenhanced and DEFINITY-enhanced rest and stress echocardiography imaging sessions will be performed on the same day. For the DEFINITY-enhanced imaging sessions all patients will receive diluted DEFINITY intravenously (IV). Diluted DEFINITY will be prepared by mixing 1 mL of activated DEFINITY® with 9 mL of normal saline in a 10 mL syringe.
Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
301382|NCT00162370|O1|Outcome|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.
Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
301383|NCT00162370|E1|Reported Event|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.
Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
301384|NCT00163293|B4|Baseline|Total|Total of all reporting groups
301385|NCT00163293|B3|Baseline|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301386|NCT00163293|B2|Baseline|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301387|NCT00163293|B1|Baseline|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301388|NCT00163293|P3|Participant Flow|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301389|NCT00163293|P2|Participant Flow|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301390|NCT00163293|P1|Participant Flow|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301391|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301392|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301393|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301394|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301395|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301401|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301402|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301403|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301404|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301405|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301406|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301407|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301408|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301409|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301410|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301411|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301412|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301413|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301414|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301524|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
301422|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301423|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301424|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301425|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301426|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301427|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301428|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301429|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301430|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301431|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301432|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301433|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301434|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301435|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301436|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301437|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301438|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301439|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301440|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301441|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301442|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301443|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301444|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301445|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301446|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301447|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301448|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301449|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301450|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301451|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301452|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301453|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301454|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301455|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301456|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301457|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301458|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301459|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301460|NCT00163293|E3|Reported Event|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301461|NCT00163293|E2|Reported Event|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301462|NCT00163293|E1|Reported Event|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
301463|NCT00163657|B4|Baseline|Total|Total of all reporting groups
301464|NCT00163657|B3|Baseline|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
301465|NCT00163657|B2|Baseline|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
301466|NCT00163657|B1|Baseline|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
301467|NCT00163657|P3|Participant Flow|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
301468|NCT00163657|P2|Participant Flow|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
301469|NCT00163657|P1|Participant Flow|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
301470|NCT00163657|O3|Outcome|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
301471|NCT00163657|O2|Outcome|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
301472|NCT00163657|O1|Outcome|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
301473|NCT00163657|O3|Outcome|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
301474|NCT00163657|O2|Outcome|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
301475|NCT00163657|O1|Outcome|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
301476|NCT00163657|E3|Reported Event|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
301477|NCT00163657|E2|Reported Event|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
301478|NCT00163657|E1|Reported Event|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
301479|NCT00165503|B1|Baseline|Cisplatin, Sodium Thiosulfate, Alimta|Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
301480|NCT00165503|P1|Participant Flow|Cisplatin, Sodium Thiosulfate, Alimta|Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
301481|NCT00165503|O1|Outcome|Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT|Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. The adjuvant chemotherapy regimen beginning 6-10 weeks after surgery is a combination of cisplatin and Alimta each given day 1 of a 21-day cycle for 3 cycles.
301482|NCT00165503|E1|Reported Event|Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate|Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours.
301483|NCT00165646|B4|Baseline|Total|Total of all reporting groups
301484|NCT00165646|B3|Baseline|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
301485|NCT00165646|B2|Baseline|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
301486|NCT00165646|B1|Baseline|Placebo|once daily orally for 4 weeks
301487|NCT00165646|P3|Participant Flow|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
301490|NCT00165646|O3|Outcome|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
301491|NCT00165646|O2|Outcome|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
301492|NCT00165646|O1|Outcome|Placebo|once daily orally for 4 weeks
301493|NCT00165646|E3|Reported Event|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
301494|NCT00165646|E2|Reported Event|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
301495|NCT00165646|E1|Reported Event|Placebo|once daily orally for 4 weeks
301496|NCT00165672|B3|Baseline|Total|Total of all reporting groups
301497|NCT00165672|B2|Baseline|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
301498|NCT00165672|B1|Baseline|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
301499|NCT00165672|P2|Participant Flow|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
301500|NCT00165672|P1|Participant Flow|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
301501|NCT00165672|O2|Outcome|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
301502|NCT00165672|O1|Outcome|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
301503|NCT00165672|E2|Reported Event|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
301504|NCT00165672|E1|Reported Event|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
301505|NCT00165698|B3|Baseline|Total|Total of all reporting groups
301506|NCT00165698|B2|Baseline|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
301507|NCT00165698|B1|Baseline|Menatetrenone|15 mg t.i.d. orally for 12 months
301508|NCT00165698|P2|Participant Flow|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
301509|NCT00165698|P1|Participant Flow|Menatetrenone|15 mg t.i.d. orally for 12 months
301510|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
301511|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
301512|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
301513|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
301514|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
301515|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
301516|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
301517|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
301518|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
301519|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
301520|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
301521|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
301533|NCT00165776|B4|Baseline|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301534|NCT00165776|B3|Baseline|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose. One subject from the 5,000 U/2 mL did not receive treatment after randomization.
301535|NCT00165776|B2|Baseline|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301536|NCT00165776|B1|Baseline|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose. Two subjects from the placebo group did not receive treatment after randomization.
301537|NCT00165776|P4|Participant Flow|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301538|NCT00165776|P3|Participant Flow|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301539|NCT00165776|P2|Participant Flow|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301540|NCT00165776|P1|Participant Flow|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
301541|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301542|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301543|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301544|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
301545|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301546|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301547|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301548|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
301549|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301550|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301551|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301552|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
301553|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301554|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301555|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301556|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
301557|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301558|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301559|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301560|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
301561|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301562|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301563|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301564|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
301565|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301566|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301567|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301568|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
301569|NCT00165776|E4|Reported Event|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301570|NCT00165776|E3|Reported Event|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301571|NCT00165776|E2|Reported Event|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
301572|NCT00165776|E1|Reported Event|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
301573|NCT00165789|B5|Baseline|Total|Total of all reporting groups
301574|NCT00165789|B4|Baseline|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301575|NCT00165789|B3|Baseline|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301576|NCT00165789|B2|Baseline|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301577|NCT00165789|B1|Baseline|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301578|NCT00165789|P4|Participant Flow|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301579|NCT00165789|P3|Participant Flow|Cohort 2- Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301580|NCT00165789|P2|Participant Flow|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301581|NCT00165789|P1|Participant Flow|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301770|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
301582|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301583|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301584|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301585|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301586|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301587|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301588|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301589|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301590|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301591|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301592|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301593|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301594|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301595|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301596|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301597|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301598|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301599|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301600|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301601|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301602|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301603|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301604|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301605|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301606|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301607|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301608|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301609|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301610|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301611|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301612|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301613|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301614|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301615|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301616|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301617|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301618|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301619|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301620|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301621|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301771|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
301622|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301623|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301624|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301625|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301626|NCT00165789|E4|Reported Event|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
301627|NCT00165789|E3|Reported Event|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301628|NCT00165789|E2|Reported Event|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
301629|NCT00165789|E1|Reported Event|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
301630|NCT00159783|B4|Baseline|Total|Total of all reporting groups
301631|NCT00159783|B3|Baseline|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
301632|NCT00159783|B2|Baseline|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
301633|NCT00159783|B1|Baseline|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
301634|NCT00159783|P3|Participant Flow|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
301635|NCT00159783|P2|Participant Flow|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
301636|NCT00159783|P1|Participant Flow|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
301637|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
301638|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
301639|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
301640|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
301641|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
301642|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
301643|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
301644|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
301645|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
301646|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
301647|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
301648|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
301649|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
301650|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
301651|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
301652|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
301653|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
301654|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
301655|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
301656|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
301657|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
301658|NCT00159783|O1|Outcome|All Treatment Groups|Asenapine 5-10 mg twice daily for 40 weeks or Olanzapine 5-20 mg daily for 40 weeks
301659|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
301660|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
301661|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
301662|NCT00159783|E3|Reported Event|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
301663|NCT00159783|E2|Reported Event|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
301664|NCT00159783|E1|Reported Event|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
301665|NCT00165841|B3|Baseline|Total|Total of all reporting groups
301666|NCT00165841|B2|Baseline|Placebo|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
301667|NCT00165841|B1|Baseline|Rabeprazole 20 mg|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
301668|NCT00165841|P2|Participant Flow|Placebo|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
301669|NCT00165841|P1|Participant Flow|Rabeprazole 20 mg|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
301670|NCT00165841|O2|Outcome|Placebo|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
301671|NCT00165841|O1|Outcome|Rabeprazole 20 mg|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
301672|NCT00165841|E2|Reported Event|Placebo|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
301673|NCT00165841|E1|Reported Event|Rabeprazole 20 mg|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
301674|NCT00165958|B3|Baseline|Total|Total of all reporting groups
301675|NCT00165958|B2|Baseline|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
301676|NCT00165958|B1|Baseline|Punch Excision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
301677|NCT00165958|P2|Participant Flow|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
301678|NCT00165958|P1|Participant Flow|Punch Excision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
301679|NCT00165958|O2|Outcome|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
301680|NCT00165958|O1|Outcome|Punch Incision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
301681|NCT00165958|E2|Reported Event|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
301682|NCT00165958|E1|Reported Event|Punch Incision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
301683|NCT00165984|B1|Baseline|Single Ventricle Patients|Patients born with single ventricle heart disease
301684|NCT00165984|P1|Participant Flow|Single Ventricle Patients|Patients born with single ventricle heart disease
301685|NCT00165984|O3|Outcome|Heterozygotes|Transplant-free survival for patients heterozygous (G/T) at nucleotide 5665 at 7 years.
301686|NCT00165984|O2|Outcome|Homozygous for Wild-type ppET1 5665|Transplant-free survival for patients homozygous for G at nucleotide 5665 at 7 years.
301687|NCT00165984|O1|Outcome|Preproendothelin-1 (ppET1) 5665 Polymorphism Homozygotes|Transplant-free survival for patients homozygous for T at nucleotide 5665 at 7 years.
301688|NCT00165984|O1|Outcome|Incidence of Preproendothelin-1 5665 Polymorphism|Incidence of Homozygosity for mutation at nucleotide 5665
301689|NCT00165984|E1|Reported Event|Single Ventricle Patients|Patients born with single ventricle heart disease
301690|NCT00166036|B3|Baseline|Total|Total of all reporting groups
301692|NCT00166036|B1|Baseline|Atorvastatin 10 mg|Subject treated with oral Atorvastatin 10 mg for 12 Weeks.
301693|NCT00166036|P2|Participant Flow|Pravastatin 80 mg|Once Daily for 12 Weeks
301694|NCT00166036|P1|Participant Flow|Atorvastatin 10 mg|Once Daily for 12 Weeks
301695|NCT00166036|O2|Outcome|Pravastatin 80 mg|Pravastatin 80 mg daily
301696|NCT00166036|O1|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg daily
301697|NCT00166036|O2|Outcome|Pravastatin 80 mg|Pravastatin 80 mg daily
301698|NCT00166036|O1|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg taken daily
301699|NCT00166036|E2|Reported Event|Pravastatin 80 mg|Subject treated with oral Pravastatin 80 mg for 12 Weeks.
301700|NCT00166036|E1|Reported Event|Atorvastatin 10 mg|Subject treated with oral Atorvastatin 10 mg for 12 Weeks.
301701|NCT00166114|B3|Baseline|Total|Total of all reporting groups
301702|NCT00166114|B2|Baseline|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
301703|NCT00166114|B1|Baseline|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 until day 56
301704|NCT00166114|P2|Participant Flow|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
301705|NCT00166114|P1|Participant Flow|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
301706|NCT00166114|O2|Outcome|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
301707|NCT00166114|O1|Outcome|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
301708|NCT00166114|E2|Reported Event|Desipramine|25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
301709|NCT00166114|E1|Reported Event|Escitalopram|10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
301710|NCT00168038|B1|Baseline|IgPro10|All subjects treated with IgPro10
301711|NCT00168038|P1|Participant Flow|IgPro10|All subjects treated with IgPro10
301712|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
301713|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
301714|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
301715|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
301716|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
301717|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
301718|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
301719|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
301720|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
301721|NCT00168038|E1|Reported Event|IgPro10|All subjects treated with IgPro10
301722|NCT00168064|B3|Baseline|Total|Total of all reporting groups
301723|NCT00168064|B2|Baseline|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%
301772|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
301724|NCT00168064|B1|Baseline|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
301725|NCT00168064|P2|Participant Flow|AP- Mechlorethamine 0.02% Compounded in Aquaphor|Compounded Mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%
301726|NCT00168064|P1|Participant Flow|PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel|Study formulation of Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
301727|NCT00168064|O2|Outcome|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%
301728|NCT00168064|O1|Outcome|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
301729|NCT00168064|O2|Outcome|AP- Aquaphor Formulation Mechlorethamine-MCH (NM) 0.02%|Mechlorethamine-MCH (Nitrogen Mustard) compounded in Aquaphor 0.02%
301730|NCT00168064|O1|Outcome|PG- Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
301731|NCT00168064|E2|Reported Event|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%
301732|NCT00168064|E1|Reported Event|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
301733|NCT00168103|B4|Baseline|Total|Total of all reporting groups
301734|NCT00168103|B3|Baseline|Placebo|Baseline data presented here are for subjects included in the ITT population. All subjects enrolled and randomized to the Placebo arm were included in the ITT analysis population.
301735|NCT00168103|B2|Baseline|C1-INH 20 U/kg bw|Baseline data presented here are for subjects included in the ITT population. All subjects enrolled and randomized to the C1-INH 20 U/kg bw arm were included in the ITT analysis population.
301736|NCT00168103|B1|Baseline|C1-INH 10 U/kg bw|Baseline characteristics were calculated only for the intention to treat (ITT) and per protocol (PP) analysis populations, not for all enrolled subjects. Baseline data presented here are for subjects included in the ITT population. One (1) subject enrolled and randomized to the C1-INH 10 U/kg bw group was excluded from the ITT analysis population.
301737|NCT00168103|P4|Participant Flow|Not Randomized|Includes one subject enrolled who was not randomized but received treatment with 20 U/kg bw C1-INH.
301738|NCT00168103|P3|Participant Flow|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
301739|NCT00168103|P2|Participant Flow|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
301740|NCT00168103|P1|Participant Flow|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1 Esterase Inhibitor (C1-INH) 10 Units (U)/kg body weight (bw) arm.
301741|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
301742|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
301743|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
301744|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
301745|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
301746|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
301747|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
301748|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
301749|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
301750|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
301751|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
301752|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
301753|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
301754|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
301755|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
301756|NCT00168103|E3|Reported Event|Placebo|Includes subjects receiving Placebo and no rescue study medication within 4 hours after the start of the initial treatment.
301757|NCT00168103|E2|Reported Event|C1-INH 20 U/kg bw|Includes subjects receiving 20 U/kg bw C1-INH and no rescue study medication within 4 hours after the start of the initial treatment (n=43). An additional 3 subjects not randomized to but treated with 20 U/kg bw C1-INH in this time period were also included in this group for the safety analysis.
301758|NCT00168103|E1|Reported Event|C1-INH 10 U/kg bw|Includes subjects receiving 10 U/kg bw C1-INH and no rescue study medication within 4 hours after the start of the initial treatment.
301759|NCT00168298|B4|Baseline|Total|Total of all reporting groups
301760|NCT00168298|B3|Baseline|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
301761|NCT00168298|B2|Baseline|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
301762|NCT00168298|B1|Baseline|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
301763|NCT00168298|P3|Participant Flow|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
301764|NCT00168298|P2|Participant Flow|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
301765|NCT00168298|P1|Participant Flow|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
301766|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
301767|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
301768|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
301773|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
301774|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
301775|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
301776|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
301777|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
301778|NCT00168298|E3|Reported Event|Sham Injection|Sham injection on Day 0.
301779|NCT00168298|E2|Reported Event|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
301780|NCT00168298|E1|Reported Event|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
301781|NCT00168311|B3|Baseline|Total|Total of all reporting groups
301782|NCT00168311|B2|Baseline|Sham Treatment|Sham bilateral rTMS treatment
301783|NCT00168311|B1|Baseline|Active Treatment|Bilateral high frequency (10Hz) rTMS
301784|NCT00168311|P2|Participant Flow|Sham Treatment|Sham bilateral rTMS treatment
301785|NCT00168311|P1|Participant Flow|Active Treatment|Bilateral high frequency (10Hz) rTMS
301786|NCT00168311|O2|Outcome|Sham Treatment|Sham bilateral rTMS treatment
301787|NCT00168311|O1|Outcome|Active Treatment|Bilateral high frequency (10Hz) rTMS
301788|NCT00168311|E2|Reported Event|Sham Treatment|Sham bilateral rTMS treatment
301789|NCT00168311|E1|Reported Event|Active Treatment|Bilateral high frequency (10Hz) rTMS
301790|NCT00168324|B4|Baseline|Total|Total of all reporting groups
301791|NCT00168324|B3|Baseline|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
301792|NCT00168324|B2|Baseline|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
301793|NCT00168324|B1|Baseline|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
301794|NCT00168324|P3|Participant Flow|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
301795|NCT00168324|P2|Participant Flow|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
301796|NCT00168324|P1|Participant Flow|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
301797|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
301798|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
301799|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
301800|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
301801|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
301802|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
301803|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
301804|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
301805|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
301806|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
301807|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
301808|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
301809|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
301810|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
301811|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
301812|NCT00168324|E3|Reported Event|Sham Injection|Sham injection on Day 0.
301813|NCT00168324|E2|Reported Event|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
301814|NCT00168324|E1|Reported Event|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
301815|NCT00168337|B4|Baseline|Total|Total of all reporting groups
301816|NCT00168337|B3|Baseline|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301817|NCT00168337|B2|Baseline|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301818|NCT00168337|B1|Baseline|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301819|NCT00168337|P3|Participant Flow|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301820|NCT00168337|P2|Participant Flow|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301821|NCT00168337|P1|Participant Flow|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301822|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301823|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301824|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301940|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
301825|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301826|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301827|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301828|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301829|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301830|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301831|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301832|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301833|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301834|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301835|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301836|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301837|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301994|NCT00168805|E3|Reported Event|Enoxaparin|40mg qd (once daily) subcutaneous
301838|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301839|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301840|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301841|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301842|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301843|NCT00168337|E3|Reported Event|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301844|NCT00168337|E2|Reported Event|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301845|NCT00168337|E1|Reported Event|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301846|NCT00168389|B4|Baseline|Total|Total of all reporting groups
301847|NCT00168389|B3|Baseline|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301848|NCT00168389|B2|Baseline|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301849|NCT00168389|B1|Baseline|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301850|NCT00168389|P3|Participant Flow|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301851|NCT00168389|P2|Participant Flow|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301852|NCT00168389|P1|Participant Flow|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301853|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301854|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301855|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301856|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301857|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301858|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301859|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301860|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301861|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301862|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301863|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301864|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301865|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301866|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301867|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301868|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301869|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301870|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301871|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301872|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301903|NCT00168454|P6|Participant Flow|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
301873|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301874|NCT00168389|E3|Reported Event|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
301875|NCT00168389|E2|Reported Event|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301876|NCT00168389|E1|Reported Event|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
301877|NCT00168428|B3|Baseline|Total|Total of all reporting groups
301878|NCT00168428|B2|Baseline|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
301879|NCT00168428|B1|Baseline|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
301880|NCT00168428|P2|Participant Flow|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
301881|NCT00168428|P1|Participant Flow|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
301882|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
301883|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
301884|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
301885|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
301886|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
301887|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
301888|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
301941|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
301889|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
301890|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
301891|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
301892|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
301893|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
301894|NCT00168428|E2|Reported Event|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
301895|NCT00168428|E1|Reported Event|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
301896|NCT00168454|B7|Baseline|Total|Total of all reporting groups
301897|NCT00168454|B6|Baseline|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
301898|NCT00168454|B5|Baseline|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
301899|NCT00168454|B4|Baseline|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
301900|NCT00168454|B3|Baseline|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
301901|NCT00168454|B2|Baseline|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
301902|NCT00168454|B1|Baseline|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
301904|NCT00168454|P5|Participant Flow|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
301905|NCT00168454|P4|Participant Flow|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
301906|NCT00168454|P3|Participant Flow|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
301907|NCT00168454|P2|Participant Flow|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
301908|NCT00168454|P1|Participant Flow|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
301909|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
301910|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
301911|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
301912|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
301913|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
301914|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
301915|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
301916|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
301917|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
301918|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
301919|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
301920|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
301921|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
301922|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
301923|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
301924|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
301925|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
301926|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
301927|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
301928|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
301929|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
301930|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
301931|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
301932|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
301933|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
301934|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
301935|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
301936|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
301937|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
301938|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
301939|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
301944|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
301945|NCT00168454|E6|Reported Event|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
301946|NCT00168454|E5|Reported Event|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
301947|NCT00168454|E4|Reported Event|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
301948|NCT00168454|E3|Reported Event|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
301949|NCT00168454|E2|Reported Event|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
301950|NCT00168454|E1|Reported Event|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
301951|NCT00168805|B4|Baseline|Total|Total of all reporting groups
301952|NCT00168805|B3|Baseline|Enoxaparin|40mg qd (once daily) subcutaneous
301953|NCT00168805|B2|Baseline|Dabigatran 150mg|qd (once daily) oral
301954|NCT00168805|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
301955|NCT00168805|P3|Participant Flow|Enoxaparin|40mg qd (once daily) subcutaneous
301956|NCT00168805|P2|Participant Flow|Dabigatran 150mg|qd (once daily) oral
301957|NCT00168805|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
301958|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
301959|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
301960|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
301961|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
301962|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
301963|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
301964|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
301965|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
301966|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
301967|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
301968|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
301969|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
301998|NCT00168818|B3|Baseline|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
301999|NCT00168818|B2|Baseline|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302000|NCT00168818|B1|Baseline|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302001|NCT00168818|P3|Participant Flow|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302002|NCT00168818|P2|Participant Flow|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302003|NCT00168818|P1|Participant Flow|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302004|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302005|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302006|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302007|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302008|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302009|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302010|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302011|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302012|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302013|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302014|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302015|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302016|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302017|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302796|NCT00174265|B1|Baseline|Asenapine|5-10 mg sublingually twice daily for 26 weeks
302018|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302019|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302020|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302021|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302022|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302023|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302024|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302025|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302026|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302027|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302028|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302071|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302029|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302030|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302031|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302032|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302033|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302034|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302035|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302036|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302037|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302038|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302039|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302040|NCT00168818|E3|Reported Event|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
302041|NCT00168818|E2|Reported Event|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302042|NCT00168818|E1|Reported Event|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
302043|NCT00168831|B4|Baseline|Total|Total of all reporting groups
302044|NCT00168831|B3|Baseline|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302045|NCT00168831|B2|Baseline|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302046|NCT00168831|B1|Baseline|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302047|NCT00168831|P3|Participant Flow|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302048|NCT00168831|P2|Participant Flow|Tiotropium Respimat 10mcg (Tio R10)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302049|NCT00168831|P1|Participant Flow|Tiotropium Respimat 5mcg (Tio R5)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302050|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302051|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302052|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302053|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302054|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302055|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302056|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302057|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302058|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302059|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302060|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302061|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302062|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302063|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302064|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302065|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302066|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302067|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302068|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302069|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302070|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302573|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302072|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302073|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302074|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302075|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302076|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302077|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302078|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302079|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302080|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302081|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302082|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302083|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302084|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302085|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302086|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302087|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302088|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302089|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302090|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302091|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302092|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302093|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302094|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302095|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302096|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302097|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302098|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302099|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302100|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302101|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302102|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302103|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
306277|NCT00184717|B4|Baseline|Total|Total of all reporting groups
302104|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302105|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302106|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302107|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302108|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302109|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302110|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302111|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302112|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302113|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302114|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302115|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302116|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302117|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302118|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302119|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302120|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302121|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302122|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302123|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302124|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302125|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302126|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302127|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302128|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302129|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302130|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302131|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302132|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302133|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302134|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302135|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302136|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302137|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302138|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302139|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302140|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302141|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302142|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302143|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302144|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302145|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302146|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302147|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302148|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302149|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302150|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302151|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302152|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302153|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302154|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302155|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302156|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302157|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302158|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302159|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302160|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302161|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302162|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302163|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302164|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302165|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302166|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302167|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302168|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302169|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302170|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302171|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302172|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302173|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302174|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302175|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302176|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302177|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302178|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302179|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302180|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302181|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302182|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302183|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302184|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302185|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302186|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302187|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302188|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302189|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302190|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302191|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302192|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302193|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302194|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302195|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302196|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302197|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302198|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302199|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302200|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302201|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302202|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302203|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302204|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302205|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302206|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302207|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302208|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302209|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302210|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302211|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302212|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302213|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302214|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302215|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302216|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302217|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302218|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302219|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302220|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302221|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302222|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302223|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302224|NCT00168831|E3|Reported Event|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302225|NCT00168831|E2|Reported Event|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302226|NCT00168831|E1|Reported Event|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302227|NCT00168844|B4|Baseline|Total|Total of all reporting groups
302228|NCT00168844|B3|Baseline|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302229|NCT00168844|B2|Baseline|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302230|NCT00168844|B1|Baseline|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302231|NCT00168844|P3|Participant Flow|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302232|NCT00168844|P2|Participant Flow|Tiotropium Respimat 10mcg (Tio R10)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302233|NCT00168844|P1|Participant Flow|Tiotropium Respimat 5mcg (Tio R5)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302234|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302235|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302236|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302237|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302238|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302239|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302240|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302241|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302242|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302243|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302244|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302245|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302246|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302247|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302248|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302249|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302250|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302251|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302252|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302253|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302254|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302255|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302256|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302257|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302258|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302259|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302260|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302261|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302262|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302263|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302264|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302265|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302266|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302267|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302268|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302269|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302270|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302271|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302272|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302273|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302274|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302275|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302276|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302277|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302278|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302279|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302280|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302281|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302282|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302283|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302284|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302285|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302286|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302287|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302288|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302289|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302290|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302291|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302292|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302293|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302294|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302295|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302296|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302297|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302298|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302299|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302300|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302301|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302302|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302303|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302304|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302305|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302306|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302307|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302308|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302309|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302310|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302311|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302312|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302313|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302314|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302315|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302316|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302317|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302318|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302319|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302320|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302321|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302322|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302323|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302324|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302325|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302326|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302327|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302328|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302329|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302330|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302331|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302332|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302333|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302334|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302335|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302336|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302337|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302338|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302339|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302340|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302341|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302342|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302343|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302344|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302345|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302346|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302347|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302348|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302349|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302350|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302351|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302352|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302353|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302354|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302355|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302356|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302357|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302358|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302359|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302360|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302361|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302362|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302363|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302364|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302365|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302366|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302367|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302368|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302369|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302370|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302371|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302372|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302373|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302374|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302375|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302376|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302377|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302378|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302379|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302380|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302381|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302382|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302383|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302384|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302385|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302386|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302387|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302388|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302389|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302390|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302391|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302392|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302393|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302394|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302395|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302396|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302397|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302398|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302399|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302400|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302401|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302402|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302403|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302404|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302405|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302406|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302407|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302408|NCT00168844|E3|Reported Event|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
302409|NCT00168844|E2|Reported Event|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
302410|NCT00168844|E1|Reported Event|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
302411|NCT00169442|B7|Baseline|Total|Total of all reporting groups
302412|NCT00169442|B6|Baseline|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302413|NCT00169442|B5|Baseline|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302414|NCT00169442|B4|Baseline|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302415|NCT00169442|B3|Baseline|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302416|NCT00169442|B2|Baseline|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302417|NCT00169442|B1|Baseline|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302441|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
328507|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
302418|NCT00169442|P6|Participant Flow|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302419|NCT00169442|P5|Participant Flow|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302420|NCT00169442|P4|Participant Flow|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302421|NCT00169442|P3|Participant Flow|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302422|NCT00169442|P2|Participant Flow|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302423|NCT00169442|P1|Participant Flow|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302424|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302425|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
302426|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
302427|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302428|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
302429|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
302430|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302431|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
302432|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
302797|NCT00174265|P2|Participant Flow|Olanzapine|5-20 mg by mouth once daily for 26 weeks
302433|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302434|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
302435|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
302436|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302437|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302438|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302439|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302440|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302569|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302442|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302443|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302444|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302445|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302446|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302447|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302448|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302449|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302450|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302451|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302452|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302453|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302454|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302455|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302456|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302457|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302458|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302459|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302460|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302461|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302462|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302463|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302464|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302465|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302466|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302467|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302468|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302469|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302470|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302471|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302472|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302473|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302474|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302475|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302476|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302477|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302478|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302479|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302480|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302481|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302482|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302483|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302484|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302485|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302486|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302487|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302488|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302489|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302490|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302491|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302492|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302493|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302494|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302495|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302496|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302497|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302498|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302798|NCT00174265|P1|Participant Flow|Asenapine|5-10 mg sublingually twice daily for 26 weeks
302499|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302500|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302501|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302502|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302503|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302504|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302505|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302506|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302507|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302508|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302509|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302510|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302511|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302512|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302513|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302514|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302515|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302516|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302517|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302518|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302519|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302520|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302799|NCT00174265|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for 26 weeks
302800|NCT00174265|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for 26 weeks
302521|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302522|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302523|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
302524|NCT00169442|E5|Reported Event|PRP TRITANRIX-HEPB KFT. REF GROUP|Healthy male and female infants who were primed with Tritanrix ™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .
302525|NCT00169442|E4|Reported Event|PRP TRITANRIX-HEPB KFT. MIX GROUP|Healthy male and female infants who were primed with Tritanrix ™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .
302526|NCT00169442|E3|Reported Event|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
302527|NCT00169442|E2|Reported Event|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
302528|NCT00169442|E1|Reported Event|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
302529|NCT00170157|B1|Baseline|Entire Study Population|All participants initially randomized.
302570|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302571|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302572|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302530|NCT00170157|P2|Participant Flow|Androgen Ablative (AA) Then AA Therapy + MDX-010|"3 months of initial AA therapy alone
Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily."
302531|NCT00170157|P1|Participant Flow|Androgen Ablative (AA) Therapy + MDX-010|"3 months of concurrent androgen ablative (AA) therapy + MDX-010
Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.
MDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7."
302532|NCT00170157|O2|Outcome|Androgen Ablative (AA) Then AA Therapy + MDX-010|"3 months of initial AA therapy alone
Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily"
302533|NCT00170157|O1|Outcome|Androgen Ablative (AA) Therapy + MDX-010|"3 months of concurrent androgen ablative (AA) therapy + MDX-010
Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.
MDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7."
302534|NCT00170157|O1|Outcome|Entire Study Population|All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone) initially randomized (i.e., before cross-over) were grouped together for this outcome.
302535|NCT00170157|E1|Reported Event|Entire Study Population|All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone the AA Therapy + MDX-010) were grouped together for this outcome.
302536|NCT00162773|B1|Baseline|All Participants|"water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE.
OR
Other Names:
Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks omalizumab: 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE."
302537|NCT00162773|P1|Participant Flow|All Participants|"water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE.
OR
Other Names:
Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks"
302538|NCT00162773|O1|Outcome|All Participants|"water injection
Placebo: 150-375 milligrams depending on body weight and serum IgE.
OR
Other Names:
Xolair 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.
omalizumab: 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE."
302801|NCT00174265|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for 26 weeks
302539|NCT00162773|E1|Reported Event|All Participants|"water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE.
OR
Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE."
302540|NCT00162942|B3|Baseline|Total|Total of all reporting groups
302541|NCT00162942|B2|Baseline|Sham|Sham, ten apheresis sessions within 9 weeks
302542|NCT00162942|B1|Baseline|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302543|NCT00162942|P2|Participant Flow|Sham|Sham, ten apheresis sessions within 9 weeks
302544|NCT00162942|P1|Participant Flow|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302545|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302546|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302547|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302548|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302549|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302550|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302551|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302552|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302553|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302554|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302555|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302556|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302557|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302558|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302559|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302560|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302561|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302562|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302563|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302564|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302565|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302566|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302567|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302568|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302574|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302575|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302576|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302577|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302578|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302579|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302580|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302581|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302582|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302583|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302584|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302585|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302586|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302587|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302588|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302589|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
302590|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
302591|NCT00162981|B3|Baseline|Total|Total of all reporting groups
302592|NCT00162981|B2|Baseline|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
302593|NCT00162981|B1|Baseline|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
302594|NCT00162981|P2|Participant Flow|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
302595|NCT00162981|P1|Participant Flow|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
302596|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
302597|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
302598|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
302599|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
302600|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
302601|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
302602|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
302603|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
302604|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
302605|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
302606|NCT00162981|E2|Reported Event|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
302607|NCT00162981|E1|Reported Event|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
302608|NCT00163020|B3|Baseline|Total|Total of all reporting groups
302609|NCT00163020|B2|Baseline|2 - Control (Castor Oil)|Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
302610|NCT00163020|B1|Baseline|1 Test Group (170HP)|Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
302611|NCT00163020|P2|Participant Flow|2 - Control (Castor Oil)|Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
302612|NCT00163020|P1|Participant Flow|1 Test Group (170HP)|Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
302613|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302614|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302615|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302616|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302617|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302618|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302619|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302620|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302621|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302622|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302623|NCT00163020|O2|Outcome|Triplet Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Triplet Pregnancies
302624|NCT00163020|O1|Outcome|Triplet Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Triplet Pregnancies
302625|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302626|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302627|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302628|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302629|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302630|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302631|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302632|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302633|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302634|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302635|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302636|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302637|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302638|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302639|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302640|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302641|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302642|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302643|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302644|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302645|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
302646|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
302647|NCT00163020|E2|Reported Event|Control (Castor Oil)|Both Twins and Triplets in the Control Group received a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first.
302648|NCT00163020|E1|Reported Event|Test Group (170HP)|Both Twins and Triplets in the Test Group received a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first.
302649|NCT00163189|B1|Baseline|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302650|NCT00163189|P1|Participant Flow|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302651|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302652|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302802|NCT00174265|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for 26 weeks
302803|NCT00174265|E2|Reported Event|Olanzapine|5-20 mg by mouth once daily for 26 weeks
302653|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302654|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302655|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302656|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302657|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302658|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302659|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302660|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302661|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302662|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302663|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302664|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302665|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302666|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302774|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
302667|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302668|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302669|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302670|NCT00163189|E1|Reported Event|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
302671|NCT00163215|B1|Baseline|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302672|NCT00163215|P1|Participant Flow|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302673|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302674|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302675|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302676|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302677|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302678|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302679|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302680|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302681|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302682|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302804|NCT00174265|E1|Reported Event|Asenapine|5-10 mg sublingually twice daily for 26 weeks
302805|NCT00174291|B3|Baseline|Total|Total of all reporting groups
302683|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302684|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302685|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302686|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302687|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302688|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302689|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302690|NCT00163215|E1|Reported Event|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
302691|NCT00170625|B1|Baseline|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
302692|NCT00170625|P1|Participant Flow|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21 Carboplatin AUC 5 on day 3, q 21
302693|NCT00170625|O1|Outcome|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
302694|NCT00170625|O1|Outcome|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
302695|NCT00170625|E1|Reported Event|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
302696|NCT00174187|B3|Baseline|Total|Total of all reporting groups
302697|NCT00174187|B2|Baseline|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302698|NCT00174187|B1|Baseline|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302775|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
302776|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
328508|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
302699|NCT00174187|P3|Participant Flow|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302700|NCT00174187|P2|Participant Flow|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302701|NCT00174187|P1|Participant Flow|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302702|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302703|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302704|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302705|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302839|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302706|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302707|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302708|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302709|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302710|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302711|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302712|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302713|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302714|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302777|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
302854|NCT00174447|P1|Participant Flow|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
302715|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302716|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302717|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302718|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302719|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302720|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302721|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302722|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
303040|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
302723|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302724|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302725|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302726|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302727|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302728|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302729|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302730|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302731|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302732|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302733|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302734|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302735|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302736|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302737|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302738|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302739|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302740|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302741|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302742|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302743|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302744|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302745|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302746|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302747|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302748|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302749|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302750|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302751|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302752|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302753|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302754|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302755|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302756|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302757|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302758|NCT00174187|E3|Reported Event|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302759|NCT00174187|E2|Reported Event|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302760|NCT00174187|E1|Reported Event|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
302761|NCT00174252|B1|Baseline|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302762|NCT00174252|P1|Participant Flow|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302763|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302764|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302765|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302766|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302767|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302768|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302769|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302770|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
302771|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
302772|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
302773|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
302778|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302779|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302780|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302781|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302782|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302783|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302784|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302785|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302786|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302787|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302788|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302789|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302790|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302791|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302792|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302793|NCT00174252|E1|Reported Event|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
302794|NCT00174265|B3|Baseline|Total|Total of all reporting groups
302795|NCT00174265|B2|Baseline|Olanzapine|5-20 mg by mouth once daily for 26 weeks
302806|NCT00174291|B2|Baseline|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302807|NCT00174291|B1|Baseline|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302808|NCT00174291|P2|Participant Flow|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302852|NCT00174382|E1|Reported Event|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302853|NCT00174447|B1|Baseline|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
302809|NCT00174291|P1|Participant Flow|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302810|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302811|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302812|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302840|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302841|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302813|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302814|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302815|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302816|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
328509|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
302817|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302818|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302819|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302820|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302821|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302822|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302823|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302824|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
303357|NCT00167180|B2|Baseline|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
302825|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302826|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302827|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302828|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302829|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302830|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302831|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302832|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
303358|NCT00167180|B1|Baseline|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
302833|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302834|NCT00174291|E2|Reported Event|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302835|NCT00174291|E1|Reported Event|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
302836|NCT00174382|B1|Baseline|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302837|NCT00174382|P1|Participant Flow|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302838|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302842|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302843|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302844|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302845|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302846|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302847|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302848|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302849|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302850|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302851|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
302855|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
302856|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
302857|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
302858|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
302859|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
302860|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
302861|NCT00174447|E1|Reported Event|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
302862|NCT00174460|B3|Baseline|Total|Total of all reporting groups
302863|NCT00174460|B2|Baseline|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302864|NCT00174460|B1|Baseline|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302865|NCT00174460|P2|Participant Flow|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302866|NCT00174460|P1|Participant Flow|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302867|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302868|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302869|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302870|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302871|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302872|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302873|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302874|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302875|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302876|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302877|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302878|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302879|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302880|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302881|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302882|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302883|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302884|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302885|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302886|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302887|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302888|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302889|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302890|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302891|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302892|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302893|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302894|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302895|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302896|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
303036|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
302897|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302898|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302899|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302900|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302901|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302902|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302903|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302904|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302905|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
303979|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
302906|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302907|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302908|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302909|NCT00174460|E2|Reported Event|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
302910|NCT00174460|E1|Reported Event|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
302911|NCT00174785|B3|Baseline|Total|Total of all reporting groups
302912|NCT00174785|B2|Baseline|Placebo|matching placebo tablets
302913|NCT00174785|B1|Baseline|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
302914|NCT00174785|P2|Participant Flow|Placebo|matching placebo tablets
302915|NCT00174785|P1|Participant Flow|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
302916|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
302917|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
302918|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
302919|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
302920|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
302921|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
302922|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
302923|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
302924|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
302925|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
302926|NCT00174785|E2|Reported Event|Placebo|matching placebo tablets
302927|NCT00174785|E1|Reported Event|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
302928|NCT00174915|B6|Baseline|Total|Total of all reporting groups
302929|NCT00174915|B5|Baseline|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
302930|NCT00174915|B4|Baseline|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302931|NCT00174915|B3|Baseline|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302932|NCT00174915|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302933|NCT00174915|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302934|NCT00174915|P5|Participant Flow|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
303037|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303038|NCT00174941|O4|Outcome|Total Febuxostat|
302935|NCT00174915|P4|Participant Flow|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302936|NCT00174915|P3|Participant Flow|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302937|NCT00174915|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302938|NCT00174915|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302939|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
302940|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302941|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302942|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302943|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302944|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
302945|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302946|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302947|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302948|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302949|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
302950|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302951|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302952|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302953|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302954|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
302955|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302956|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302957|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302958|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302959|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
302960|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302961|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302962|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302963|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302964|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
302965|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302966|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302967|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302968|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302969|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
302970|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302971|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302972|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302973|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302974|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
302975|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302976|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302977|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302978|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302979|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
303039|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
302980|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302981|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302982|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302983|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302984|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
302985|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302986|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302987|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302988|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302989|NCT00174915|E5|Reported Event|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
302990|NCT00174915|E4|Reported Event|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
302991|NCT00174915|E3|Reported Event|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
302992|NCT00174915|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
302993|NCT00174915|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
302994|NCT00174941|B4|Baseline|Total|Total of all reporting groups
302995|NCT00174941|B3|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level
302996|NCT00174941|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level
302997|NCT00174941|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg orally, once daily, based on serum urate level.
302998|NCT00174941|P4|Participant Flow|Total Febuxostat|
302999|NCT00174941|P3|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303000|NCT00174941|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303001|NCT00174941|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303002|NCT00174941|O4|Outcome|Total Febuxostat|
303003|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303004|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303005|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303006|NCT00174941|O4|Outcome|Total Febuxostat|
303007|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303008|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303009|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303010|NCT00174941|O4|Outcome|Total Febuxostat|
303011|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303012|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303013|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303014|NCT00174941|O4|Outcome|Total Febuxostat|
303015|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303016|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303017|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303018|NCT00174941|O4|Outcome|Total Febuxostat|
303019|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303020|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303021|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303022|NCT00174941|O4|Outcome|Total Febuxostat|
303023|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303024|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303025|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303026|NCT00174941|O4|Outcome|Total Febuxostat|
303027|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303028|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303029|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303030|NCT00174941|O4|Outcome|Total Febuxostat|
303031|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303032|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303033|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303034|NCT00174941|O4|Outcome|Total Febuxostat|
303035|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303107|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303041|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303042|NCT00174941|O4|Outcome|Total Febuxostat|
303043|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303044|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303045|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303046|NCT00174941|O4|Outcome|Total Febuxostat|
303047|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303048|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303049|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303050|NCT00174941|O4|Outcome|Total Febuxostat|
303051|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303052|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303053|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303054|NCT00174941|O4|Outcome|Total Febuxostat|
303055|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303056|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303057|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303058|NCT00174941|O4|Outcome|Total Febuxostat|
303059|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303060|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303061|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303062|NCT00174941|O4|Outcome|Total Febuxostat|
303063|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
303064|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
303065|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
303066|NCT00174941|E4|Reported Event|Febuxostat Total|
303067|NCT00174941|E3|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily, based on serum urate level
303068|NCT00174941|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily, based on serum urate level
303069|NCT00174941|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg taken orally, once daily, based on serum urate level.
303070|NCT00174954|B1|Baseline|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
303071|NCT00174954|P1|Participant Flow|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
303072|NCT00174954|O1|Outcome|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
303073|NCT00174954|O1|Outcome|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
303074|NCT00174954|E1|Reported Event|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
303075|NCT00174967|B5|Baseline|Total|Total of all reporting groups
303076|NCT00174967|B4|Baseline|Placebo QD|Placebo, orally, once daily
303077|NCT00174967|B3|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303078|NCT00174967|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303079|NCT00174967|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303080|NCT00174967|P4|Participant Flow|Placebo QD|Placebo, orally, once daily
303081|NCT00174967|P3|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303082|NCT00174967|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303083|NCT00174967|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303084|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
303085|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303086|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303087|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303088|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
303089|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303090|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303091|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303092|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
303093|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303094|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303095|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303096|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
303097|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303098|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303099|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303100|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
303101|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303102|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303103|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303104|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
303105|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303106|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303109|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303110|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303111|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303112|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
303113|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303114|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303115|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303116|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
303117|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303118|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303119|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303120|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
303121|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303122|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303123|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303124|NCT00174967|E4|Reported Event|Placebo QD|Placebo, orally, once daily
303125|NCT00174967|E3|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
303126|NCT00174967|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
303127|NCT00174967|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
303128|NCT00175006|B1|Baseline|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
303129|NCT00175006|P1|Participant Flow|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
303130|NCT00175006|O1|Outcome|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
303131|NCT00175006|O1|Outcome|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
303132|NCT00175006|E1|Reported Event|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
303133|NCT00175019|B4|Baseline|Total|Total of all reporting groups
303134|NCT00175019|B3|Baseline|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303135|NCT00175019|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303136|NCT00175019|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303137|NCT00175019|P3|Participant Flow|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303138|NCT00175019|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303139|NCT00175019|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303140|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303141|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303142|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303143|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303144|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303145|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303146|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303147|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303148|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303149|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303150|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303151|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303152|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303153|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303154|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303155|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303156|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303157|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303158|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303159|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303160|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303161|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303162|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303163|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303164|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303165|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303166|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303167|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303168|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303169|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
308937|NCT00212134|B3|Baseline|Total|Total of all reporting groups
303170|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303171|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303172|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303173|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303174|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303175|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303176|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303177|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303178|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303179|NCT00175019|E3|Reported Event|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
303180|NCT00175019|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
303181|NCT00175019|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
303182|NCT00175877|B1|Baseline|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303183|NCT00175877|P1|Participant Flow|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303284|NCT00166296|B2|Baseline|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303184|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303185|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303186|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303187|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303188|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303189|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303190|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303191|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303225|NCT00176202|O1|Outcome|Divalproex|Divalproex was titrated up to 15 mg/kg/day over 3 days and serum level was measured at the end of 5 days. Divalproex dose was immediately adjusted on obtaining the serum level to aim for 80–120 μg/ml- trough, while ensuring that the dose was tolerated when increased. Serum valproate level was repeated at the end of the study.
303192|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303193|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303194|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303195|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303196|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303238|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22
Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22
Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
303350|NCT00167102|O2|Outcome|Placebo|
303197|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303198|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303199|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303200|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303201|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303202|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303203|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303204|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303205|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303206|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303207|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303208|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303209|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303239|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22
Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22
Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
303351|NCT00167102|O1|Outcome|Alefacept|
303210|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303211|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303212|NCT00175877|E1|Reported Event|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study."
303213|NCT00176202|B3|Baseline|Total|Total of all reporting groups
303214|NCT00176202|B2|Baseline|Divalproex|Divalproex sodium, also referred to as divalproex is an antiepileptic medication used for mania and is referred to as mood stabilizer. Its trade name is Depakote.
303215|NCT00176202|B1|Baseline|Risperidone|"Risperidone is an antipsychotic medication and is used to treat mania. Its trade name is Risperdal.
Aim of the study is to cross compare the relative efficacy and safety of risperidone and divalproex sodium in treating/stabilizing mania in pediatric bipolar disorder."
303216|NCT00176202|P2|Participant Flow|Divalproex Sodium|This is antiepileptic medication and is a comparator drug to see if it is as efficacious as risperidone assumption is both have equal efficacy with no difference between the two.
303217|NCT00176202|P1|Participant Flow|Risperidone|The study aimed to compare the antipsychotic medication i.e., risperidone's efficacy with that of divalproex sodium (which is an antiepileptic medication) in treating/stabilizing pediatric bipolar disorder.
303218|NCT00176202|O2|Outcome|Divalproex Sodium|Antiepileptic medication used as mood stabilizer/antimanic agent
303219|NCT00176202|O1|Outcome|Risperidone|Antipsychotic medication used as a anti manic agent
303220|NCT00176202|O2|Outcome|Divalproex Sodium|Antiepileptic medication used as mood stabilizer/antimanic agent
303221|NCT00176202|O1|Outcome|Risperidone|Antipsychotic medication used as a anti manic agent
303222|NCT00176202|O2|Outcome|Risperidone|Risperidone was initiated at 0.25 mg to 0.50 mg per day. The dose was titrated to a maximum of 2 mg per day by increments of 0.25–0.5 mg every 2 days to achieve a maximum tolerable level by day 7.
303223|NCT00176202|O1|Outcome|Divalproex|Divalproex was titrated up to 15 mg/kg/day over 3 days and serum level was measured at the end of 5 days. Divalproex dose was immediately adjusted on obtaining the serum level to aim for 80–120 μg/ml- trough, while ensuring that the dose was tolerated when increased. Serum valproate level was repeated at the end of the study.
303224|NCT00176202|O2|Outcome|Risperidone|Risperidone was initiated at 0.25 mg to 0.50 mg per day. The dose was titrated to a maximum of 2 mg per day by increments of 0.25–0.5 mg every 2 days to achieve a maximum tolerable level by day 7.
303262|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
303226|NCT00176202|E2|Reported Event|Depakote or Divalproex Sodium|"Likely side effects include gastrointestinal side effects such as stomach discomfort, weight gain, agitation and sedation, fatigue or tiredness.
Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level."
303227|NCT00176202|E1|Reported Event|Risperidone|"Likely side effects include weight gain, muscle stiffness, sedation and tiredness.
Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level."
303228|NCT00176228|B1|Baseline|Lamotrigine|upto 200 mg
303229|NCT00176228|P1|Participant Flow|Lamotrigine|upto 200 mg
303230|NCT00176228|O1|Outcome|Lamotrigine|Lamotrigine: Response on CDRS-R
303231|NCT00176228|O1|Outcome|Lamotrigine Effectiveness on YMRS (Mania Measure)|
303232|NCT00176228|E1|Reported Event|Lamotrigine|upto 200 mg
303233|NCT00176254|B1|Baseline|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22
Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22
Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
303234|NCT00176254|P1|Participant Flow|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22
Paclitaxel : 225 mg/m^2 intravenously over three hours on Days 1 and 22
Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
303235|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22
Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22
Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
303236|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22
Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22
Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
303237|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22
Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22
Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
303352|NCT00167102|O2|Outcome|Placebo|Weekly intramuscular administration of placebo 15 mg for 12 weeks
303240|NCT00176254|E1|Reported Event|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22
Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22
Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
303241|NCT00176306|B1|Baseline|Levofloxacin Arm|patients receiving levofloxacin
303242|NCT00176306|P1|Participant Flow|Levofloxacin Arm|Patients receive commercially available levofloxacin 750mg solution for intravnous use
303243|NCT00176306|O1|Outcome|Levofloxacin Arm|Subjects receiving levofloxacin
303244|NCT00176306|E1|Reported Event|Levofloxacin Arm|patients receiving levofloxacin
303245|NCT00166166|B3|Baseline|Total|Total of all reporting groups
303246|NCT00166166|B2|Baseline|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
303247|NCT00166166|B1|Baseline|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
303248|NCT00166166|P2|Participant Flow|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
303249|NCT00166166|P1|Participant Flow|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
303250|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin, fluconazole and tetraethylammonium (TEA)
303251|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and fluconazole
303252|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and Tetraethylammonium (TEA)
303253|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin
303254|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside
303255|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside
303256|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of fluconazole and Tetraethylammonium (TEA)
303257|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA) and fluconazole
303258|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA), and fluconazole
303259|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole
303260|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole.
303261|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
303390|NCT00167245|O2|Outcome|Placebo|placebo : placebo pills
303263|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
303264|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
303265|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA)
303266|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA).
303267|NCT00166166|E2|Reported Event|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
303268|NCT00166166|E1|Reported Event|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
303269|NCT00166205|B1|Baseline|Swedish Adjustable Gastric Band (SAGB)|
303270|NCT00166205|P1|Participant Flow|Swedish Adjustable Gastric Band (SAGB)|
303271|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
303272|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
303273|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
303274|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
303275|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
303276|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
303277|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
303278|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
303279|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
303280|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
303281|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
303282|NCT00166205|E1|Reported Event|Swedish Adjustable Gastric Band (SAGB)|
303283|NCT00166296|B3|Baseline|Total|Total of all reporting groups
303285|NCT00166296|B1|Baseline|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303286|NCT00166296|P2|Participant Flow|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303287|NCT00166296|P1|Participant Flow|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303288|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303289|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303290|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303291|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303292|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303293|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303294|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303295|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303296|NCT00166296|E2|Reported Event|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303297|NCT00166296|E1|Reported Event|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
303298|NCT00166361|B3|Baseline|Total|Total of all reporting groups
303299|NCT00166361|B2|Baseline|JJ Stent|Subjects assigned to this arm received a JJ stent.
303300|NCT00166361|B1|Baseline|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
303301|NCT00166361|P2|Participant Flow|JJ Stent|Subjects assigned to this arm received a JJ stent.
303302|NCT00166361|P1|Participant Flow|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
303303|NCT00166361|O2|Outcome|JJ Stent|Subjects assigned to this arm received a JJ stent.
303304|NCT00166361|O1|Outcome|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
303305|NCT00166361|E2|Reported Event|JJ Stent|Subjects assigned to this arm received a JJ stent.
303306|NCT00166361|E1|Reported Event|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
303307|NCT00166504|B3|Baseline|Total|Total of all reporting groups
303308|NCT00166504|B2|Baseline|Atorvastatin|Atorvastatin 10 mg
303309|NCT00166504|B1|Baseline|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
303310|NCT00166504|P2|Participant Flow|Atorvastatin|Atorvastatin 10 mg
303311|NCT00166504|P1|Participant Flow|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
303312|NCT00166504|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
303313|NCT00166504|O1|Outcome|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
303314|NCT00166504|E2|Reported Event|Atorvastatin|Atorvastatin 10 mg
303315|NCT00166504|E1|Reported Event|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
303316|NCT00166517|B3|Baseline|Total|Total of all reporting groups
303317|NCT00166517|B2|Baseline|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
303318|NCT00166517|B1|Baseline|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
303319|NCT00166517|P2|Participant Flow|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
303320|NCT00166517|P1|Participant Flow|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
303321|NCT00166517|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
303322|NCT00166517|O1|Outcome|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
303323|NCT00166517|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
303324|NCT00166517|O1|Outcome|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
303325|NCT00166517|E2|Reported Event|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
303326|NCT00166517|E1|Reported Event|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
303327|NCT00166712|B3|Baseline|Total|Total of all reporting groups
303328|NCT00166712|B2|Baseline|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.
If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
303353|NCT00167102|O1|Outcome|Alefacept|Weekly intramuscular administration of alefacept 15mg for 12 weeks
303329|NCT00166712|B1|Baseline|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC (Prograf) started on the 1st day after surgery, and then taken by mouth twice daily.
303330|NCT00166712|P2|Participant Flow|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.
If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
303331|NCT00166712|P1|Participant Flow|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
303332|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.
If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
303333|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
303334|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.
If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
303335|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
303336|NCT00166712|O2|Outcome|Group 2|Evaluated for rejection of their transplanted kidney with a biopsy.
303337|NCT00166712|O1|Outcome|Group 1|Evaluated for rejection of their transplanted kidney with a biopsy.
303391|NCT00167245|O1|Outcome|Topiramate|"topiramate
Topiramate : 300mg/day for 13 weeks"
303392|NCT00167245|O2|Outcome|Placebo|placebo : placebo pills
303393|NCT00167245|O1|Outcome|Topirmate|"topiramate
Topiramate : 300mg/day for 13 weeks"
303394|NCT00167245|E2|Reported Event|Placebo|placebo : placebo pills
303338|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.
If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
303339|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
303340|NCT00166712|O2|Outcome|Group 2|Evaluated for rejection of their transplanted kidney with a biopsy.
303341|NCT00166712|O1|Outcome|Groups|Evaluated for rejection of their transplanted kidney with a biopsy.
303342|NCT00166712|E3|Reported Event|Group 1: Post-conversion to Sirolimus|After conversion to Sirolimus, if no rejection of transplanted kidney within 9 months post-transplant, will be weaned off Sirolimus.
303343|NCT00166712|E2|Reported Event|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.
If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
303344|NCT00166712|E1|Reported Event|Group 1: Alemtuzumab + TAC + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
303345|NCT00167102|B3|Baseline|Total|Total of all reporting groups
303346|NCT00167102|B2|Baseline|Placebo|
303347|NCT00167102|B1|Baseline|Alefacept|
303348|NCT00167102|P2|Participant Flow|Placebo|Weekly IM administration of placebo, for 12 weeks, followed by a 12-week, posttreatment observation period.
303349|NCT00167102|P1|Participant Flow|Alefacept|Weekly IM administration of alefacept,15 mg, for 12 weeks, followed by a 12-week, posttreatment observation period.
303359|NCT00167180|P2|Participant Flow|Non-CML or CML Failing Donor Lymphocyte Infusion|"Patients with non-CML or CML who have failed DLI and will receive Induction Chemotherapy + DLI.
Induction Chemotherapy + DLI: Fludarabine 25 mg/m2 IV Cyclosphosphamide 60 mg/kg IV Donor Lymphocyte Infusion (DLI)"
303360|NCT00167180|P1|Participant Flow|Chronic Myelogenous Leukemia (CML)|"Patients who have failed or refused Gleevec (TM) therapy and will receive Donor Lymphocyte Infusion.
Donor Lymphocyte Infusion: donor cells infused over 2 hrs at cell dose of 0.5 dx 10^8 CD3+T-cells/kg"
303361|NCT00167180|O2|Outcome|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
303362|NCT00167180|O1|Outcome|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
303363|NCT00167180|O2|Outcome|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
303364|NCT00167180|O1|Outcome|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
303365|NCT00167180|O2|Outcome|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
303366|NCT00167180|O1|Outcome|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
303367|NCT00167180|O2|Outcome|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
303368|NCT00167180|O1|Outcome|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
303369|NCT00167180|O2|Outcome|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
303370|NCT00167180|O1|Outcome|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
303371|NCT00167180|E2|Reported Event|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
303372|NCT00167180|E1|Reported Event|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
303373|NCT00167206|B1|Baseline|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303374|NCT00167206|P1|Participant Flow|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303375|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303376|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303377|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303378|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303379|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303380|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303381|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303382|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303383|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303384|NCT00167206|E1|Reported Event|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
303385|NCT00167245|B3|Baseline|Total|Total of all reporting groups
303386|NCT00167245|B2|Baseline|Group 2|placebo : placebo pills
303387|NCT00167245|B1|Baseline|Group 1|"topiramate
Topiramate : 300mg/day for 13 weeks"
303388|NCT00167245|P2|Participant Flow|Placebo|placebo : placebo pills
303389|NCT00167245|P1|Participant Flow|Topiramate|"topiramate
Topiramate : 300mg/day for 13 weeks"
303395|NCT00167245|E1|Reported Event|Topiramate|"topiramate
Topiramate : 300mg/day for 13 weeks"
303396|NCT00167310|B3|Baseline|Total|Total of all reporting groups
303397|NCT00167310|B2|Baseline|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
303398|NCT00167310|B1|Baseline|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
303399|NCT00167310|P2|Participant Flow|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
303400|NCT00167310|P1|Participant Flow|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
303401|NCT00167310|O2|Outcome|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
303402|NCT00167310|O1|Outcome|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
303403|NCT00167310|O2|Outcome|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
303504|NCT00176462|O1|Outcome|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
303404|NCT00167310|O1|Outcome|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
303405|NCT00167310|E2|Reported Event|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
303406|NCT00167310|E1|Reported Event|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
303407|NCT00167388|B5|Baseline|Total|Total of all reporting groups
303408|NCT00167388|B4|Baseline|Group 4|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.
Weight >1250 at time of study and randomized to not feeding during the PRBC transfusion"
303409|NCT00167388|B3|Baseline|Group 3|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.
Weight >1250 at time of study and randomized to feeding during the PRBC transfusion"
303410|NCT00167388|B2|Baseline|Group 2|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.
Weight <1250 at time of study and randomized to not feeding during the PRBC transfusion"
303411|NCT00167388|B1|Baseline|Group 1|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.
Weight <1250 at time of study and randomized to feeding during the PRBC transfusion"
303412|NCT00167388|P4|Participant Flow|Group 4|>1250 gm at time of study, Not fed during PRBC transfusion
303413|NCT00167388|P3|Participant Flow|Group 3|>1250 gm at time of study, Fed during PRBC transfusion
303414|NCT00167388|P2|Participant Flow|Group 2|<1250 gm at time of study, Not fed during PRBC transfusion
303415|NCT00167388|P1|Participant Flow|Group 1|<1250 gm at time of study, Fed during PRBC transfusion
303416|NCT00167388|O2|Outcome|Groups 3 and 4|Infants >1250 gm, irrespective of whether they were fed or NPO during the PRBC transfusion
303417|NCT00167388|O1|Outcome|Groups 1 and 2|Infants <1250 gm, irrespective of whether they were fed or NPO during the PRBC transfusion
303418|NCT00167388|E4|Reported Event|Group 4|>1250 gm, not fed during the study
303419|NCT00167388|E3|Reported Event|Group 3|>1250 gm, fed during the study
303420|NCT00167388|E2|Reported Event|Group 2|<1250 gm, not fed during the study
303421|NCT00167388|E1|Reported Event|Group 1|< 1250 gm Fed during the study
303422|NCT00167544|B3|Baseline|Total|Total of all reporting groups
303423|NCT00167544|B2|Baseline|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
303424|NCT00167544|B1|Baseline|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
303425|NCT00167544|P2|Participant Flow|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
303451|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303426|NCT00167544|P1|Participant Flow|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
303427|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
303428|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
303429|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
303430|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
303431|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
303432|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
303433|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
303434|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
303435|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
303436|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
303437|NCT00167544|E2|Reported Event|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
303438|NCT00167544|E1|Reported Event|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
303439|NCT00167778|B1|Baseline|Amputee|Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol.
303440|NCT00167778|P1|Participant Flow|Amputee|This is a randomized cross-over study. Each participant wore both study prostheses: (1) a rigid pylon and (2) a transverse plane torsion adapter. The torsion adapter was initially set according to the manufacturer's recommendations based on body mass and activity level. After one week of acclimation, additional stiffness adjustments were made based on participant feedback. This process continued until the perceived stiffness was optimized. All participants were able to find a comfortable fit either on the first or second visit. Subjects were then randomized, provided with one of two study prostheses, and asked to wear it for 3 weeks. Data was then collected during lab visit 1, and following 1 more week, additional data was collected during lab visit 2. Subjects were then provided with the second study prosthesis and asked to wear it for 3 weeks. Data was then collected during lab visit 3, and following 1 more week, additional data was collected during lab visit 4.
303441|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303442|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303443|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303444|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303445|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303446|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303447|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303448|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303449|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303450|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303452|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303453|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303454|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303455|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303456|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303457|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303458|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303459|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303460|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303461|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303462|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303463|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303464|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303632|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
303465|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303466|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303467|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303468|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303469|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303470|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303471|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303472|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303473|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303474|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303475|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303476|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303477|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303478|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303479|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303480|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303481|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303482|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303483|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
303484|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303485|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
304129|NCT00182078|E1|Reported Event|Placebo|Placebo group who received no study medication.
303486|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
303487|NCT00167778|E1|Reported Event|Amputee|Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol.
303488|NCT00176436|B3|Baseline|Total|Total of all reporting groups
303489|NCT00176436|B2|Baseline|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
303490|NCT00176436|B1|Baseline|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
303491|NCT00176436|P2|Participant Flow|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
303492|NCT00176436|P1|Participant Flow|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
303493|NCT00176436|O2|Outcome|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
303494|NCT00176436|O1|Outcome|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
303495|NCT00176436|E2|Reported Event|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
303496|NCT00176436|E1|Reported Event|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
303497|NCT00176462|B3|Baseline|Total|Total of all reporting groups
303498|NCT00176462|B2|Baseline|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
303499|NCT00176462|B1|Baseline|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
303500|NCT00176462|P2|Participant Flow|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
303501|NCT00176462|P1|Participant Flow|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
303502|NCT00176462|O2|Outcome|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
303503|NCT00176462|O1|Outcome|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
303505|NCT00176462|E2|Reported Event|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
303506|NCT00176462|E1|Reported Event|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
303507|NCT00176488|B1|Baseline|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
epirubicin : Epirubicin (100 mg/m2) will be given on Day 1
vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
303508|NCT00176488|P1|Participant Flow|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
epirubicin : Epirubicin (100 mg/m2) will be given on Day 1
vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
Beginning on cycle 1, patients will receive G-CSF (Neupogen) at a dose of 5 mcg/kg on Day 4 of treatment for 10 days OR pegfilgrastim (Neulasta) 6 mg on Day 4 of treatment."
303509|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
epirubicin : Epirubicin (100 mg/m2) will be given on Day 1
vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
303510|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
epirubicin : Epirubicin (100 mg/m2) will be given on Day 1
vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
303511|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
epirubicin : Epirubicin (100 mg/m2) will be given on Day 1
vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
303512|NCT00176488|E1|Reported Event|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
epirubicin : Epirubicin (100 mg/m2) will be given on Day 1
vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
303513|NCT00176501|B1|Baseline|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
303514|NCT00176501|P1|Participant Flow|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
303602|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
303515|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
303516|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
303517|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
303518|NCT00176501|E1|Reported Event|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
303519|NCT00176605|B1|Baseline|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
303520|NCT00176605|P1|Participant Flow|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
303633|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
303634|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
303521|NCT00176605|O1|Outcome|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
303522|NCT00176605|O1|Outcome|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
303523|NCT00176605|E1|Reported Event|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
303524|NCT00176631|B1|Baseline|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
303525|NCT00176631|P1|Participant Flow|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
303526|NCT00176631|O1|Outcome|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
303527|NCT00176631|O1|Outcome|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
303528|NCT00176631|E1|Reported Event|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
303529|NCT00176644|B1|Baseline|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
303530|NCT00176644|P1|Participant Flow|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
303531|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
303532|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
303577|NCT00177294|B2|Baseline|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
303533|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
303534|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
303535|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
303536|NCT00176644|E1|Reported Event|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
303537|NCT00177164|B3|Baseline|Total|Total of all reporting groups
303538|NCT00177164|B2|Baseline|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)
Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
303539|NCT00177164|B1|Baseline|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)
Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
303540|NCT00177164|P2|Participant Flow|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)
Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
303541|NCT00177164|P1|Participant Flow|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)
Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
303542|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)
Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
303543|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)
Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
303544|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)
Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
303545|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)
Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
303546|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)
Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
303547|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)
Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
303548|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)
Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
303549|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)
Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
303550|NCT00177164|E2|Reported Event|Oral AAP|
303551|NCT00177164|E1|Reported Event|Risperidone LAI|
303552|NCT00177216|B4|Baseline|Total|Total of all reporting groups
303553|NCT00177216|B3|Baseline|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
303554|NCT00177216|B2|Baseline|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
303555|NCT00177216|B1|Baseline|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
303556|NCT00177216|P3|Participant Flow|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
303625|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
303635|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
303557|NCT00177216|P2|Participant Flow|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
303558|NCT00177216|P1|Participant Flow|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
303559|NCT00177216|O3|Outcome|Placebo|Participants receiving a placebo
303560|NCT00177216|O2|Outcome|Escitalopram|Participants receiving an antidepressant, escitalopram
303561|NCT00177216|O1|Outcome|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
303562|NCT00177216|O3|Outcome|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
303563|NCT00177216|O2|Outcome|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
303564|NCT00177216|O1|Outcome|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
303565|NCT00177216|O3|Outcome|Placebo|Participants receiving a placebo
303566|NCT00177216|O2|Outcome|Escitalpram|Participants receiving an antidepressant, escitalopram
303567|NCT00177216|O1|Outcome|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
303568|NCT00177216|E3|Reported Event|Placebo|Participants receiving a placebo
303569|NCT00177216|E2|Reported Event|Escitalopram|Participants receiving an antidepressant, escitalopram
303570|NCT00177216|E1|Reported Event|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
303571|NCT00177255|B1|Baseline|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22."
303603|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
303604|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
303804|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
303572|NCT00177255|P1|Participant Flow|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22."
303573|NCT00177255|O1|Outcome|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22."
303574|NCT00177255|O1|Outcome|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22."
303575|NCT00177255|E1|Reported Event|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22."
303576|NCT00177294|B3|Baseline|Total|Total of all reporting groups
303626|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
303578|NCT00177294|B1|Baseline|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
303579|NCT00177294|P2|Participant Flow|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
303580|NCT00177294|P1|Participant Flow|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
303581|NCT00177294|O2|Outcome|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
303582|NCT00177294|O1|Outcome|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
303583|NCT00177294|E2|Reported Event|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
303584|NCT00177294|E1|Reported Event|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
303585|NCT00177307|B1|Baseline|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
303605|NCT00177671|E2|Reported Event|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
303606|NCT00177671|E1|Reported Event|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
303607|NCT00177866|B3|Baseline|Total|Total of all reporting groups
303608|NCT00177866|B2|Baseline|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
303586|NCT00177307|P1|Participant Flow|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
303587|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
303588|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
303589|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
303590|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
303627|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
303628|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
303629|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
303630|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
303631|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
303591|NCT00177307|E1|Reported Event|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
303592|NCT00177671|B3|Baseline|Total|Total of all reporting groups
303593|NCT00177671|B2|Baseline|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
303594|NCT00177671|B1|Baseline|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
303595|NCT00177671|P2|Participant Flow|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
303596|NCT00177671|P1|Participant Flow|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
303597|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
303598|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
303599|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
303600|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
303601|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
303805|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
303609|NCT00177866|B1|Baseline|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks
Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
303610|NCT00177866|P2|Participant Flow|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
303611|NCT00177866|P1|Participant Flow|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks
Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
303612|NCT00177866|O2|Outcome|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
303613|NCT00177866|O1|Outcome|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks
Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
303614|NCT00177866|O2|Outcome|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
303615|NCT00177866|O1|Outcome|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks
Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
303616|NCT00177866|E2|Reported Event|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
303617|NCT00177866|E1|Reported Event|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks
Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
303618|NCT00177970|B3|Baseline|Total|Total of all reporting groups
303619|NCT00177970|B2|Baseline|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
303620|NCT00177970|B1|Baseline|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
303621|NCT00177970|P2|Participant Flow|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
303622|NCT00177970|P1|Participant Flow|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
303623|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
303624|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
303636|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
303637|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
303638|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
303639|NCT00177970|E2|Reported Event|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
303640|NCT00177970|E1|Reported Event|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
303641|NCT00178126|B3|Baseline|Total|Total of all reporting groups
303642|NCT00178126|B2|Baseline|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion
Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
303643|NCT00178126|B1|Baseline|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes
Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
303644|NCT00178126|P2|Participant Flow|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion
Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
303645|NCT00178126|P1|Participant Flow|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes
Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
303646|NCT00178126|O2|Outcome|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion
Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
303647|NCT00178126|O1|Outcome|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes
Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
303648|NCT00178126|E2|Reported Event|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion
Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
303649|NCT00178126|E1|Reported Event|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes
Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
303650|NCT00178178|B5|Baseline|Total|Total of all reporting groups
303651|NCT00178178|B4|Baseline|Placebo Comparator|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303652|NCT00178178|B3|Baseline|Drug: Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303653|NCT00178178|B2|Baseline|Drug: Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303703|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
303654|NCT00178178|B1|Baseline|Drug: Intraarticularly Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303655|NCT00178178|P4|Participant Flow|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303656|NCT00178178|P3|Participant Flow|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303657|NCT00178178|P2|Participant Flow|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303658|NCT00178178|P1|Participant Flow|Intraarticulary Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303659|NCT00178178|O4|Outcome|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303660|NCT00178178|O3|Outcome|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303661|NCT00178178|O2|Outcome|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303662|NCT00178178|O1|Outcome|Intraarticulary Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303663|NCT00178178|E4|Reported Event|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303722|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
303664|NCT00178178|E3|Reported Event|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303665|NCT00178178|E2|Reported Event|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303666|NCT00178178|E1|Reported Event|Intraartciularly Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
303667|NCT00178191|B4|Baseline|Total|Total of all reporting groups
303668|NCT00178191|B3|Baseline|Placebo|Placebo
303669|NCT00178191|B2|Baseline|300 Units Botox|300 units Botulinum-A toxin
303670|NCT00178191|B1|Baseline|200 Units Botox|200 units Botulinum-A toxin
303671|NCT00178191|P3|Participant Flow|Placebo|Placebo
303672|NCT00178191|P2|Participant Flow|300 Units Botox|300 units Botulinum-A toxin
303673|NCT00178191|P1|Participant Flow|200 Units Botox|200 units Botulinum-A toxin
303674|NCT00178191|O3|Outcome|Placebo|Placebo
303675|NCT00178191|O2|Outcome|300 Units Botox|300 units Botulinum-A toxin
303676|NCT00178191|O1|Outcome|200 Units Botox|200 units Botulinum-A toxin
303677|NCT00178191|E3|Reported Event|Placebo|Placebo
303678|NCT00178191|E2|Reported Event|300 Units Botox|300 units Botulinum-A toxin
303679|NCT00178191|E1|Reported Event|200 Units Botox|200 units Botulinum-A toxin
303680|NCT00178256|B1|Baseline|Daily RT Plus Chemo on MWF|"Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am."
303681|NCT00178256|P4|Participant Flow|Phase II Group (20mg/m2 Taxol)|"Once the MTD has been determined and confirmed with a total of six patients, up to 19 additional patients with measurable disease will be enrolled at that dose in order to obtain estimates of response rate and more information about toxicity Phase II enrollment will be in two stages. Initially 9 or 12 patients (depending on how many were tested at the MTD dose in the Phase I study) will be tested, for a total of 15 patients at the MTD. If fewer than 4 responses are observed, the study will end with 90% confidence that the true response rate is no greater than 40%, which is the minimum clinically interesting response rate.
If four or more responses are observed, additional patients will be enrolled to obtain 25 evaluable patients at the MTD. This will allow estimation of the true response rate and toxicity rates with standard errors of no more than 0.1."
303704|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
303705|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
303885|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
303682|NCT00178256|P3|Participant Flow|Third Dose Cohort (25mg/m2 Taxol) MWF and Daily RT|"A minimum of three patients will be assigned at each dose level.
If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.
If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.
Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
303683|NCT00178256|P2|Participant Flow|Second Dose Cohort (20mg/m2 Taxol) MWF and Daily RT|"On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.
A minimum of three patients will be assigned at each dose level.
If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.
If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.
Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
303684|NCT00178256|P1|Participant Flow|First Dose Cohort (15mg/m2 Taxol) MWF and Daily RT|"On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.
A minimum of three patients will be assigned at each dose level.
If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.
If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.
Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
303685|NCT00178256|O1|Outcome|All Pts Enrolled Daily RT Plus Chemo on MWF|"Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am."
303686|NCT00178256|O3|Outcome|3rd Dose Cohort --25mg/m2 Taxol Plus RT|"Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
303687|NCT00178256|O2|Outcome|2nd Dose cohort20 mg/m2 Taxol Plus Daily RT|"Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
303980|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
303688|NCT00178256|O1|Outcome|1st Dose Cohort 15mg/m2 Taxol Plus RT|"15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
303689|NCT00178256|E1|Reported Event|All Subjects Enrolled|
303690|NCT00178464|B1|Baseline|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
303691|NCT00178464|P1|Participant Flow|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
303692|NCT00178464|O1|Outcome|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
303693|NCT00178464|O1|Outcome|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
303694|NCT00178464|E1|Reported Event|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
303695|NCT00178477|B1|Baseline|Group 1|MRI with Breath Hold
303696|NCT00178477|P1|Participant Flow|Breath Hold|MRI with Breath Hold
303697|NCT00178477|O1|Outcome|Group 1|MRI with Breath Hold
303698|NCT00178477|E1|Reported Event|Group 1|MRI with Breath Hold
303699|NCT00178503|B1|Baseline|MPH Trial|24 Participants with ASD-ADHD underwent 1 week of placebo, 1 week of Low dose, 1 week of Medium dose, and 1 week of High dose in the MPH treatment phase
303700|NCT00178503|P1|Participant Flow|MPH Trial|24 participants with autism spectrum disorder and ADHD underwent a randomized, placebo-controlled, cross-over designed trial, which included: 1 week of placebo, 1 week of low dose methylphenidate, 1 week of medium dose methylphenidate, 1 week of high dose methylphenidate.
303701|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
303702|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
303706|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
303707|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|Participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
303708|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
303709|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phasephase
303710|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
303711|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
303712|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|All 24 participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
303713|NCT00178503|E4|Reported Event|MPH Trial: High Dose|Participants with ASD-ADHD who will undergo 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
303714|NCT00178503|E3|Reported Event|MPH Trial: Med Dose|Participants with ASD-ADHD who will undergo 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
303715|NCT00178503|E2|Reported Event|MPH Trial: Low Dose|Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
303716|NCT00178503|E1|Reported Event|MPH Trial-Placebo|Participants with ASD-ADHD who will undergo 1 week of placebo in the MPH treatment phase
303717|NCT00178633|B1|Baseline|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
303718|NCT00178633|P1|Participant Flow|Bariatric Surgery|
303719|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
303720|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
303721|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
303723|NCT00178633|E2|Reported Event|Bariatric Surgery, Follow up at 2 Years|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
303724|NCT00178633|E1|Reported Event|Bariatric Surgery, Follow up at 9 Months|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
303725|NCT00178685|B4|Baseline|Total|Total of all reporting groups
303726|NCT00178685|B3|Baseline|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
303727|NCT00178685|B2|Baseline|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
303728|NCT00178685|B1|Baseline|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
303729|NCT00178685|P3|Participant Flow|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
303730|NCT00178685|P2|Participant Flow|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
303731|NCT00178685|P1|Participant Flow|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
303732|NCT00178685|O3|Outcome|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
303733|NCT00178685|O2|Outcome|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
303734|NCT00178685|O1|Outcome|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
303735|NCT00178685|O3|Outcome|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
303736|NCT00178685|O2|Outcome|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
303737|NCT00178685|O1|Outcome|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
303763|NCT00178919|O2|Outcome|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
303981|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303738|NCT00178685|E3|Reported Event|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
303739|NCT00178685|E2|Reported Event|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
303740|NCT00178685|E1|Reported Event|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
303741|NCT00178711|B3|Baseline|Total|Total of all reporting groups
303742|NCT00178711|B2|Baseline|Control|Treated at normothermia
303743|NCT00178711|B1|Baseline|Hypothermia|"Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.
Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours"
303744|NCT00178711|P2|Participant Flow|Control|45 patients who had none of the second set of exclusion criteria and who has been randomized to normothermia served as the control group
303745|NCT00178711|P1|Participant Flow|Hypothermia|"There were two sets of exclusion criteria-one in the field; the other after resuscitation in the ER. In the field, patients were excluded for suspected pregnancy, systolic blood pressure <110 mm Hg, diastolic blood pressure <60 mm Hg, sustained heart rate >120 beats per minute, or failure to be reached by study-affiliated personnel within 2.5 hours of injury.
Those that did not have any of the first set of exclusion criteria were further assessed for the presence of Glasgow Coma Scale 3-8 without life-threatening associated injuries. The second set of exclusion criteria were GCS 3 with nonreactive pupils, GCS 7-8 with normal brain CT scan, inability to obtain an accurate GCS, Abbreviated Injury Severity Score >4 for organs other than brain4, systolic blood pressure <110 mm Hg or diastolic blood pressure <60 mm Hg, persistent hypoxia, (oxygen saturation < 94%), or positive pregnancy test."
303746|NCT00178711|O2|Outcome|Control|treated at normothermia
303747|NCT00178711|O1|Outcome|Hypothermia|"Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.
Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours"
303748|NCT00178711|E4|Reported Event|Randomized to Normothermia Then Excluded|Maintenance of normothermia before trauma evaluation in ED and then excluded by second set of criteria
303749|NCT00178711|E3|Reported Event|Randomized to Hypothermia and Then Excluded|Induction and maintenance of moderate hypothermia before trauma evaluation in ED and then excluded by second set of criteria
303750|NCT00178711|E2|Reported Event|Randomized to Normothermia and Normothermia Maintained|Induction and maintenance of normothermia and not excluded by second set of exclusion criteria
303751|NCT00178711|E1|Reported Event|Randomized to Hypothermia and Hypothermia Maintained|Induction and maintenance of moderate hypothermia and not excluded by second set of exclusion criteria
303752|NCT00178841|B1|Baseline|Single Arm Study|All enrolled patients received rosiglitazone in addition to oral bexarotene
303753|NCT00178841|P1|Participant Flow|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
303754|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
303755|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
303756|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|All 4 enrolled patients received rosiglitazone in addition to oral bexarotene.
303757|NCT00178841|E1|Reported Event|Rosiglitazone and Bexarotene|All enrolled patients received rosiglitazone in addition to oral bexarotene.
303758|NCT00178919|B3|Baseline|Total|Total of all reporting groups
303759|NCT00178919|B2|Baseline|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
303760|NCT00178919|B1|Baseline|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
303761|NCT00178919|P2|Participant Flow|Hypertensives and Controls|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (250, 500 mcg/kg/min) for 15 minutes each dose after acute transient pharmacological blockade of the autonomic nervous system with trimethaphan (4 mg/min) or with the autonomic nervous system intact.
303762|NCT00178919|P1|Participant Flow|Autonomic Failure Patients|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (125, 250 and 500 mcg/kg/min) until a systolic blood pressure of 150 mm Hg was reached.
303982|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303764|NCT00178919|O1|Outcome|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
303765|NCT00178919|O2|Outcome|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
303766|NCT00178919|O1|Outcome|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
303767|NCT00178919|E2|Reported Event|Hypertensives and Controls|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (250, 500 mcg/kg/min) for 15 minutes each dose after acute transient pharmacological blockade of the autonomic nervous system with trimethaphan (4 mg/min) or with the autonomic nervous system intact.
303768|NCT00178919|E1|Reported Event|Autonomic Failure Patients|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (125, 250 and 500 mcg/kg/min) until a systolic blood pressure of 150 mm Hg was reached.
303769|NCT00179309|B3|Baseline|Total|Total of all reporting groups
303770|NCT00179309|B2|Baseline|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)"
303771|NCT00179309|B1|Baseline|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V : given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV"
303772|NCT00179309|P2|Participant Flow|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin 1(MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)"
303773|NCT00179309|P1|Participant Flow|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V: given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV"
303803|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
303774|NCT00179309|O2|Outcome|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)"
303775|NCT00179309|O1|Outcome|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V : given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV"
303776|NCT00179309|O2|Outcome|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)"
303777|NCT00179309|O1|Outcome|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V : given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV"
303823|NCT00171834|B1|Baseline|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303824|NCT00171834|P7|Participant Flow|Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
303778|NCT00179309|E2|Reported Event|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)"
303779|NCT00179309|E1|Reported Event|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V : given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV"
303780|NCT00179413|B3|Baseline|Total|Total of all reporting groups
303781|NCT00179413|B2|Baseline|Colchicine|"0.6mg twice a day
Colchicine: 0.6mg twice a day"
303782|NCT00179413|B1|Baseline|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC
PEG -Intron"
303783|NCT00179413|P2|Participant Flow|Colchicine|"0.6mg twice a day
Colchicine: 0.6mg twice a day"
303784|NCT00179413|P1|Participant Flow|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC
PEG -Intron"
303785|NCT00179413|O2|Outcome|Colchicine|"0.6mg twice a day
Colchicine: 0.6mg twice a day"
303786|NCT00179413|O1|Outcome|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC
PEG -Intron"
303787|NCT00179413|O2|Outcome|Colchicine|"0.6mg twice a day
Colchicine: 0.6mg twice a day"
303788|NCT00179413|O1|Outcome|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC
PEG -Intron"
303789|NCT00179413|O2|Outcome|Colchicine|"0.6mg twice a day
Colchicine: 0.6mg twice a day"
303790|NCT00179413|O1|Outcome|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC
PEG -Intron"
303791|NCT00179413|E2|Reported Event|Colchicine|"0.6mg twice a day
Colchicine: 0.6mg twice a day"
303792|NCT00179413|E1|Reported Event|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC
PEG -Intron"
303793|NCT00171704|B3|Baseline|Total|Total of all reporting groups
303794|NCT00171704|B2|Baseline|Tam-Let|Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
303795|NCT00171704|B1|Baseline|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
303796|NCT00171704|P2|Participant Flow|Tam-Let|Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
303797|NCT00171704|P1|Participant Flow|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
303798|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
303799|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
303800|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
303801|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
303802|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
303806|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
303807|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
303808|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
303809|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
303810|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
303811|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
303812|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
303813|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
303814|NCT00171704|E2|Reported Event|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
303815|NCT00171704|E1|Reported Event|Letrozole|2.5 mg once daily q.d. orally for 5 years
303816|NCT00171834|B8|Baseline|Total|Total of all reporting groups
303817|NCT00171834|B7|Baseline|Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
303818|NCT00171834|B6|Baseline|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
303819|NCT00171834|B5|Baseline|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303820|NCT00171834|B4|Baseline|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303821|NCT00171834|B3|Baseline|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303822|NCT00171834|B2|Baseline|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303983|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
303825|NCT00171834|P6|Participant Flow|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
303826|NCT00171834|P5|Participant Flow|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303827|NCT00171834|P4|Participant Flow|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303828|NCT00171834|P3|Participant Flow|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303829|NCT00171834|P2|Participant Flow|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303830|NCT00171834|P1|Participant Flow|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303831|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
303832|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
303833|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
303834|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
303835|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
303836|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
303837|NCT00171834|O1|Outcome|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
303838|NCT00171834|O13|Outcome|Patupilone 13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303839|NCT00171834|O12|Outcome|Patupilone 12.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303840|NCT00171834|O11|Outcome|Patupilone 11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303841|NCT00171834|O10|Outcome|Patupilone 11.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303842|NCT00171834|O9|Outcome|Patupilone 10.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303843|NCT00171834|O8|Outcome|Patupilone 10.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303844|NCT00171834|O7|Outcome|Patupilone 9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303845|NCT00171834|O6|Outcome|Patupilone 9.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303846|NCT00171834|O5|Outcome|Patupilone 8.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303847|NCT00171834|O4|Outcome|Patupilone 8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303848|NCT00171834|O3|Outcome|Patupilone 7.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303849|NCT00171834|O2|Outcome|Patupilone 7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303850|NCT00171834|O1|Outcome|Patupilone 6.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303851|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
303852|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
303853|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
303854|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
303855|NCT00171834|O5|Outcome|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303856|NCT00171834|O4|Outcome|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303857|NCT00171834|O3|Outcome|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303858|NCT00171834|O2|Outcome|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303899|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
303859|NCT00171834|O1|Outcome|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303860|NCT00171834|E7|Reported Event|Patupilone 10 mg/m^2 (Phase II) NSCLC w. Brain Metastases (BM)|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
303861|NCT00171834|E6|Reported Event|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
303862|NCT00171834|E5|Reported Event|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303863|NCT00171834|E4|Reported Event|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303864|NCT00171834|E3|Reported Event|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303865|NCT00171834|E2|Reported Event|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303866|NCT00171834|E1|Reported Event|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
303867|NCT00171873|B3|Baseline|Total|Total of all reporting groups
303868|NCT00171873|B2|Baseline|Placebo|Sodium chloride intramuscularly every 28 days
303869|NCT00171873|B1|Baseline|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
303870|NCT00171873|P2|Participant Flow|Placebo|Sodium chloride intramuscularly every 28 days
303871|NCT00171873|P1|Participant Flow|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
303872|NCT00171873|O2|Outcome|Placebo|Sodium chloride intramuscularly every 28 days
303873|NCT00171873|O1|Outcome|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
303874|NCT00171873|E2|Reported Event|Placebo|Sodium chloride intramuscularly every 28 days
303875|NCT00171873|E1|Reported Event|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
303876|NCT00171925|B3|Baseline|Total|Total of all reporting groups
303877|NCT00171925|B2|Baseline|Control|No Treatment with study medication.
303878|NCT00171925|B1|Baseline|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
303879|NCT00171925|P2|Participant Flow|Control|No Treatment with study medication.
303880|NCT00171925|P1|Participant Flow|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
303881|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
303882|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
303883|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
303884|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
303886|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
303887|NCT00171925|E2|Reported Event|Control|No treatment with study medication.
303888|NCT00171925|E1|Reported Event|Zoledronic Acid|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
303889|NCT00172042|B3|Baseline|Total|Total of all reporting groups
303890|NCT00172042|B2|Baseline|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
303891|NCT00172042|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
303892|NCT00172042|P2|Participant Flow|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
303893|NCT00172042|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
303894|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
303895|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
303896|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
303897|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
303898|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
303900|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
303901|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
303902|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
303903|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
303904|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
303905|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
303906|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
303907|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
303908|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
303909|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
303910|NCT00172042|E2|Reported Event|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
303911|NCT00172042|E1|Reported Event|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
303912|NCT00172185|B5|Baseline|Total|Total of all reporting groups
303913|NCT00172185|B4|Baseline|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
303914|NCT00172185|B3|Baseline|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
303915|NCT00172185|B2|Baseline|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
303916|NCT00172185|B1|Baseline|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
303917|NCT00172185|P4|Participant Flow|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
303918|NCT00172185|P3|Participant Flow|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
303919|NCT00172185|P2|Participant Flow|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
303920|NCT00172185|P1|Participant Flow|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
303921|NCT00172185|O4|Outcome|0.10/0.10|Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
303922|NCT00172185|O3|Outcome|0.05/0.05|Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
303923|NCT00172185|O2|Outcome|Placebo/0.10|Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
303924|NCT00172185|O1|Outcome|Placebo/0.05|Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
303925|NCT00172185|O4|Outcome|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
303926|NCT00172185|O3|Outcome|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
303927|NCT00172185|O2|Outcome|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
303928|NCT00172185|O1|Outcome|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
303929|NCT00172185|E4|Reported Event|0.10/0.10|Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
303930|NCT00172185|E3|Reported Event|0.05/0.05|Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
303931|NCT00172185|E2|Reported Event|Placebo/0.10|Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
303932|NCT00172185|E1|Reported Event|Placebo/0.05|Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
303933|NCT00179517|B3|Baseline|Total|Total of all reporting groups
303934|NCT00179517|B2|Baseline|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303935|NCT00179517|B1|Baseline|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303936|NCT00179517|P2|Participant Flow|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303937|NCT00179517|P1|Participant Flow|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303978|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303938|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303939|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303940|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303941|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303942|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303943|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303944|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303945|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303946|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303947|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303948|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303949|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303950|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303951|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303952|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303953|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303954|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303955|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303956|NCT00179517|E2|Reported Event|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.
Placebo Oral Tablet"
303957|NCT00179517|E1|Reported Event|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.
Anastrozole 1mg"
303958|NCT00179621|B4|Baseline|Total|Total of all reporting groups
303959|NCT00179621|B3|Baseline|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303960|NCT00179621|B2|Baseline|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303961|NCT00179621|B1|Baseline|Placebo|Placebo matching to active study arms.
303962|NCT00179621|P4|Participant Flow|Placebo Crossover to 5 mg Open-label Period|Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
303963|NCT00179621|P3|Participant Flow|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303964|NCT00179621|P2|Participant Flow|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303965|NCT00179621|P1|Participant Flow|Placebo|Placebo matching to active study arms.
303966|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303967|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303968|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
303969|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303970|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303971|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
303972|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303973|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303974|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
303975|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303976|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303977|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
303984|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303985|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303986|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
303987|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303988|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303989|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
303990|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303991|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303992|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
303993|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303994|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303995|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
303996|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
303997|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
303998|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
303999|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
304000|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
304001|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
304002|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
304003|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
304004|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
304005|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
304006|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
304007|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
304008|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
304009|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
304010|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
304011|NCT00179621|E4|Reported Event|Placebo Crossover to 5 mg Open-label Period|Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
304012|NCT00179621|E3|Reported Event|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
304013|NCT00179621|E2|Reported Event|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
304014|NCT00179621|E1|Reported Event|Placebo|Placebo matching to active study arms.
304015|NCT00179647|B1|Baseline|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
304038|NCT00180687|B3|Baseline|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
304039|NCT00180687|B2|Baseline|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline"
304130|NCT00182091|B5|Baseline|Total|Total of all reporting groups
304016|NCT00179647|P1|Participant Flow|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
304017|NCT00179647|O1|Outcome|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
304018|NCT00179647|E1|Reported Event|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
304019|NCT00179660|B1|Baseline|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304020|NCT00179660|P1|Participant Flow|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304021|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304022|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304023|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304093|NCT00181714|O1|Outcome|OROS-Methylphenidate|
306089|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
304024|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304025|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304026|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304027|NCT00179660|E1|Reported Event|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304028|NCT00179673|B1|Baseline|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304029|NCT00179673|P1|Participant Flow|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304030|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304031|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304032|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304033|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304034|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304035|NCT00179673|E1|Reported Event|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
304036|NCT00180687|B5|Baseline|Total|Total of all reporting groups
304037|NCT00180687|B4|Baseline|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
304040|NCT00180687|B1|Baseline|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
304041|NCT00180687|P4|Participant Flow|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
304042|NCT00180687|P3|Participant Flow|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
304043|NCT00180687|P2|Participant Flow|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline"
304044|NCT00180687|P1|Participant Flow|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
304045|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
304046|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
304047|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline"
304048|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
304049|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
304050|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
304051|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline"
304052|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
304053|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
304054|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
304055|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline"
304056|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
304057|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
304058|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
304059|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline"
304060|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
304061|NCT00180687|E4|Reported Event|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
304062|NCT00180687|E3|Reported Event|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
304063|NCT00180687|E2|Reported Event|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline"
304064|NCT00180687|E1|Reported Event|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
304065|NCT00181155|B1|Baseline|Intravenous Allopurinol|We randomized patients with nonischemic cardiomyopathy in a double-blind fashion to allopurinol (300 mg intravenously) or placebo infusion, 4-to-1, the latter for purposes of blinding only. The myocardial concentrations of ATP and creatine phosphate (PCr) and the rate of adenosine triphosphate (ATP) synthesis through CK (CK flux) were determined by 31-Phosphorus (31P) magnetic resonance spectroscopy.
304066|NCT00181155|P2|Participant Flow|Placebo|Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
304067|NCT00181155|P1|Participant Flow|Allopurinol|Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
304068|NCT00181155|O1|Outcome|Intravenous Allopurinol|Infused Aloprim 300 mg in 50cc of 5% dextrose. Post infusion MRS data acquired on each subject.
304069|NCT00181155|O1|Outcome|Intravenous Allopurinol|Infused Aloprim 300 mg in 50cc 5% dextrose. Post MRS data acquired on each subject.
304070|NCT00181155|O1|Outcome|Baseline|Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
304071|NCT00181155|O1|Outcome|Baseline|Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
304072|NCT00181155|E2|Reported Event|Arm 2 - Placebo|Each participant received pre and post MRS images following infusion of 50 cc of 5% Dextrose (equivalent volume to active treatment arm).
304073|NCT00181155|E1|Reported Event|Arm 1 - Intravenous Allopurinol|Each participant received pre and post MRS images following infusion of 50 cc of Aloprim 300mg in 5% Dextrose.
304074|NCT00181610|B4|Baseline|Total|Total of all reporting groups
304128|NCT00182078|E2|Reported Event|Sertraline|Sertraline group received study medication every day for 12 weeks.
309041|NCT00214487|B3|Baseline|Total|Total of all reporting groups
304075|NCT00181610|B3|Baseline|Recombinant Human Prolactin Once Per Day|"Recombinant human prolactin alternating with placebo every 12 hours
Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours"
304076|NCT00181610|B2|Baseline|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours
Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
304077|NCT00181610|B1|Baseline|Placebo Twice Per Day|"Placebo group
Normal Saline : twice per day"
304078|NCT00181610|P3|Participant Flow|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours
Recombinant human prolactin : 60 mcg/kg given every 24 hours alternating with normal saline placebo given once every 24 hours"
304079|NCT00181610|P2|Participant Flow|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours
Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
304080|NCT00181610|P1|Participant Flow|Placebo Twice Per Day|"Placebo group
Normal Saline : twice per day"
304081|NCT00181610|O3|Outcome|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours
Recombinant human prolactin : 60 mcg/kg given every 24 hours Placebo given every 24 hours"
304082|NCT00181610|O2|Outcome|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours
Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
304083|NCT00181610|O1|Outcome|Placebo Twice Per Day|"Placebo group
Normal Saline : twice per day"
304084|NCT00181610|E3|Reported Event|Recombinant Human Prolactin Once Per Day|"Recombinant human prolactin alternating with placebo every 12 hours
Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours"
304085|NCT00181610|E2|Reported Event|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours
Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
304086|NCT00181610|E1|Reported Event|Placebo Twice Per Day|"Placebo group
Normal Saline : twice per day"
304087|NCT00181623|B1|Baseline|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin
Recombinant Human Prolactin :"
304088|NCT00181623|P1|Participant Flow|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin 60 mcg/kg
Recombinant Human Prolactin :"
304089|NCT00181623|O1|Outcome|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin
Recombinant Human Prolactin :"
304090|NCT00181623|E1|Reported Event|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin
Recombinant Human Prolactin :"
304091|NCT00181714|B1|Baseline|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
304092|NCT00181714|P1|Participant Flow|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
304094|NCT00181714|E1|Reported Event|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
304095|NCT00181766|B1|Baseline|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
304096|NCT00181766|P1|Participant Flow|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
304097|NCT00181766|O1|Outcome|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
304098|NCT00181766|O1|Outcome|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
304099|NCT00181766|E1|Reported Event|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
304100|NCT00181844|B1|Baseline|Lamotrigine|
304101|NCT00181844|P1|Participant Flow|Lamotrigine|
304102|NCT00181844|O1|Outcome|Lamotrigine|
304103|NCT00181844|E1|Reported Event|Lamotrigine|
304104|NCT00181883|B1|Baseline|Quetiapine|
304105|NCT00181883|P1|Participant Flow|Quetiapine|
304106|NCT00181883|O1|Outcome|Quetiapine|
304107|NCT00181883|E1|Reported Event|Quetiapine|
304108|NCT00182000|B3|Baseline|Total|Total of all reporting groups
304109|NCT00182000|B2|Baseline|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
304110|NCT00182000|B1|Baseline|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
304111|NCT00182000|P2|Participant Flow|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
304112|NCT00182000|P1|Participant Flow|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
304113|NCT00182000|O2|Outcome|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
304114|NCT00182000|O1|Outcome|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
304115|NCT00182000|E2|Reported Event|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
304116|NCT00182000|E1|Reported Event|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
304117|NCT00182078|B3|Baseline|Total|Total of all reporting groups
304118|NCT00182078|B2|Baseline|Sertraline|Sertraline group received study medication every day for 12 weeks.
304119|NCT00182078|B1|Baseline|Placebo|Placebo group who received no study medication.
304120|NCT00182078|P2|Participant Flow|Sertraline - Received Study Medication|The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
304121|NCT00182078|P1|Participant Flow|Placebo - Received Placebo|The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinued.
304122|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
304123|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
304124|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
304125|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
304126|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
304127|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
304131|NCT00182091|B4|Baseline|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
304132|NCT00182091|B3|Baseline|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
304133|NCT00182091|B2|Baseline|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
304134|NCT00182091|B1|Baseline|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
304135|NCT00182091|P4|Participant Flow|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
304136|NCT00182091|P3|Participant Flow|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
304137|NCT00182091|P2|Participant Flow|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
304138|NCT00182091|P1|Participant Flow|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
304139|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
304140|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
304141|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
304142|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
304143|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
304144|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
306090|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
304145|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
304146|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
304147|NCT00182091|E4|Reported Event|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
304148|NCT00182091|E3|Reported Event|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
304149|NCT00182091|E2|Reported Event|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
304150|NCT00182091|E1|Reported Event|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
304151|NCT00182637|B1|Baseline|Bortezomib|administration of bortezomib
304152|NCT00182637|P1|Participant Flow|Bortezomib|administration of bortezomib
304153|NCT00182637|O1|Outcome|Bortezomib|administration of bortezomib
304154|NCT00182637|O1|Outcome|Bortezomib|administration of bortezomib
304155|NCT00182637|O1|Outcome|Bortezomib|bortezomib
304156|NCT00182637|E1|Reported Event|Bortezomib|administration of bortezomib
304157|NCT00182689|B3|Baseline|Total|Total of all reporting groups
304158|NCT00182689|B2|Baseline|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
304159|NCT00182689|B1|Baseline|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
304160|NCT00182689|P2|Participant Flow|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
304161|NCT00182689|P1|Participant Flow|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
304162|NCT00182689|O2|Outcome|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
304163|NCT00182689|O1|Outcome|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
304164|NCT00182689|O2|Outcome|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
304165|NCT00182689|O1|Outcome|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
304166|NCT00182689|O2|Outcome|Platinum Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
304167|NCT00182689|O1|Outcome|Platinum Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
304168|NCT00182689|E2|Reported Event|Platinum Refractory|
304169|NCT00182689|E1|Reported Event|Platinum Sensitive|
304279|NCT00183274|P5|Participant Flow|Phase 3: Double-Blind Relapse Phase (Placebo After Drug)|Patients administered venlafaxine XR in Phase 2 were given a placebo in Phase 3
304170|NCT00182728|B1|Baseline|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy"
304171|NCT00182728|P1|Participant Flow|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy"
304172|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy"
304173|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy"
304174|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy"
304175|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy"
304176|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy"
304177|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy"
304178|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy"
304179|NCT00182728|E1|Reported Event|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy"
304180|NCT00182754|B3|Baseline|Total|Total of all reporting groups
304181|NCT00182754|B2|Baseline|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
304182|NCT00182754|B1|Baseline|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
304183|NCT00182754|P2|Participant Flow|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
304184|NCT00182754|P1|Participant Flow|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
304185|NCT00182754|O2|Outcome|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
304186|NCT00182754|O1|Outcome|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
304187|NCT00182754|O2|Outcome|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
304188|NCT00182754|O1|Outcome|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
304189|NCT00182754|O2|Outcome|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
304190|NCT00182754|O1|Outcome|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
304191|NCT00182754|E2|Reported Event|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
304192|NCT00182754|E1|Reported Event|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
304193|NCT00182767|B1|Baseline|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304194|NCT00182767|P5|Participant Flow|Ixabepilone: 16mg/m2 and Doxil 30 mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304195|NCT00182767|P4|Participant Flow|Ixabepilone: 13mg/m2 and Doxil 30 mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304196|NCT00182767|P3|Participant Flow|Ixabepilone: 40mg/m2 and Doxil 30 mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304197|NCT00182767|P2|Participant Flow|Ixabepilone: 32mg/m2 and Doxil 30 mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304198|NCT00182767|P1|Participant Flow|Ixabepilone: 24mg/m2 and Doxil 30 mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304199|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304200|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304201|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304202|NCT00182767|O5|Outcome|Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304203|NCT00182767|O4|Outcome|Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304204|NCT00182767|O3|Outcome|Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304205|NCT00182767|O2|Outcome|Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304206|NCT00182767|O1|Outcome|Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304207|NCT00182767|E5|Reported Event|Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304208|NCT00182767|E4|Reported Event|Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304209|NCT00182767|E3|Reported Event|Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304210|NCT00182767|E2|Reported Event|Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304211|NCT00182767|E1|Reported Event|Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV"
304245|NCT00183196|B2|Baseline|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
304246|NCT00183196|B1|Baseline|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
304766|NCT00189423|E2|Reported Event|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
304212|NCT00182793|B1|Baseline|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
304213|NCT00182793|P1|Participant Flow|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
304214|NCT00182793|O1|Outcome|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
304215|NCT00182793|O1|Outcome|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
304216|NCT00182793|E1|Reported Event|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
304217|NCT00183092|B3|Baseline|Total|Total of all reporting groups
304218|NCT00183092|B2|Baseline|Quinacrine|Quinacrine : 100mg by mouth three times a day
304219|NCT00183092|B1|Baseline|Placebo|Placebo : 100mg by mouth three times a day
304220|NCT00183092|P4|Participant Flow|Study Drug (Placebo) During Open-Label Period|Participants received Placebo during Double-Blind period and opted to continue study drug during Open-Label period
304788|NCT00189475|B1|Baseline|Montelukast|"Treated for 4 months with montelukast 4 mg per day
Montelukast"
304221|NCT00183092|P3|Participant Flow|Study Drug (Quinacrine) During Open-Label Period|Participants received Quinacrine during Double-Blind period and opted to continue study drug during Open-Label period
304222|NCT00183092|P2|Participant Flow|Placebo|Double Blind Period: 100mg Placebo by mouth three times a day. Open Label Period: Choice of study drug or Quinacrine 100mg by mouth three times a day.
304223|NCT00183092|P1|Participant Flow|Quinacrine|Double Blind Period: 100mg Quinacrine by mouth three times a day. Open Label Period: Choice of study drug or open-label Quinacrine 100mg by mouth three times a day.
304224|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
304225|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
304226|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
304227|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
304228|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
304229|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
304230|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
304231|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
304232|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
304233|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
304234|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
304235|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
304236|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
304237|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
304238|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
304239|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
304240|NCT00183092|E3|Reported Event|Quinacrine Open-label|Quinacrine: Month 2 until death = optional open-label Quinacrine 100mg by mouth three times a day
304241|NCT00183092|E2|Reported Event|Quinacrine Random Assignment|Quinacrine: 100mg by mouth three times a day. Baseline-Month 2 = random assignment (n=23), Month 2+ = optional continuation of assigned drug (n=1).
304242|NCT00183092|E1|Reported Event|Placebo Random Assignment|Placebo : 100mg by mouth three times a day, Baseline-Month 2 = random assignment (n=28), Month 2+ = optional continuation of assigned drug (n=1).
304243|NCT00183196|B4|Baseline|Total|Total of all reporting groups
304244|NCT00183196|B3|Baseline|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
306091|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
304247|NCT00183196|P3|Participant Flow|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
304248|NCT00183196|P2|Participant Flow|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
304249|NCT00183196|P1|Participant Flow|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
304250|NCT00183196|O3|Outcome|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
304251|NCT00183196|O2|Outcome|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
304252|NCT00183196|O1|Outcome|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
304253|NCT00183196|E3|Reported Event|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
304254|NCT00183196|E2|Reported Event|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
304255|NCT00183196|E1|Reported Event|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
304256|NCT00183248|B3|Baseline|Total|Total of all reporting groups
304257|NCT00183248|B2|Baseline|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
304258|NCT00183248|B1|Baseline|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
304259|NCT00183248|P2|Participant Flow|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
304260|NCT00183248|P1|Participant Flow|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
304261|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304789|NCT00189475|P2|Participant Flow|Placebo|Treated for 4 months with placebo
304262|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304263|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304264|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304265|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304266|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304267|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304268|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304298|NCT00170846|B3|Baseline|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
328510|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
304269|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304270|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304271|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304272|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304273|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304274|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
304275|NCT00183248|E2|Reported Event|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
304276|NCT00183248|E1|Reported Event|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
304277|NCT00183274|B1|Baseline|Venlafaxine XR|"Venlafaxine XR flexible dose of 75 - 225 mg/d
Venlafaxine XR : All participants will take venlafaxine for 6 months. After this initial 6 months, participants who are not randomized to placebo will continue to take venlafaxine."
304278|NCT00183274|P6|Participant Flow|Phase 3: Double-Blind Relapse Phase (Placebo After Placebo)|Patients administered placebo in Phase 2 continued to take placebo during Phase 3
304280|NCT00183274|P4|Participant Flow|Phase 3: Double-Blind Relapse Phase (Drug After Drug)|Patients administered venlafaxine XR in phase 2 continued to take the drug during phase 3
304281|NCT00183274|P3|Participant Flow|Phase 2: Double-Blind Placebo|Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in a 60:40 ratio of drug to placebo
304282|NCT00183274|P2|Participant Flow|Phase 2: Double-Blind Venlafaxine XR|Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in 60:40 ratio of drug to placebo
304283|NCT00183274|P1|Participant Flow|Phase 1: Open-Label|Patients received 75mg - 225 mg of open-label venlafaxine XR for 6 months.
304284|NCT00183274|O6|Outcome|Placebo After Placebo|after receiving drug in phases 1 and placebo in phase 2, patients received placebo in phase 3
304285|NCT00183274|O5|Outcome|Phase 3: Placebo After Drug|after receiving drug in phases 1 and 2, patients received placebo in phase 3
304286|NCT00183274|O4|Outcome|Phase 3: Double-Blind Drug After Drug|after receiving drug in phases 1 and 2, patients continued to receive drug in phase 3
304287|NCT00183274|O3|Outcome|Phase 2: Double-Blind Placebo|After receiving drug in Phase 1, patients began receiving placebo in phase 2
304288|NCT00183274|O2|Outcome|Phase 2: Double-Blind Venlafaxine XR|after receiving drug in phase 1, patients continued to receive drug in phase 2
304289|NCT00183274|O1|Outcome|Phase 1: Open-Label Venlafaxine XR|A 6-month administration of Venlafaxine XR that occurred between months 1 - 6 of study.
304290|NCT00183274|O6|Outcome|Double-Blind Placebo After Placebo|A 6-month double-blind administration of placebo that occurred between months 13 - 18.
304291|NCT00183274|O5|Outcome|Double-Blind Relapse Placebo After Drug|A 6-month double-blind administration of placebo that occurred between months 13 - 18.
304292|NCT00183274|O4|Outcome|Double-Blind Relapse Drug After Drug|A 6-month double-blind administration of Venlafaxine XR that occurred between months 13 - 18.
304293|NCT00183274|O3|Outcome|Double-Blind Placebo|A 6-month double-blind administration of placebo that occurred between months 7 - 12.
304294|NCT00183274|O2|Outcome|Double-Blind Venlafaxine XR|A 6-month double-blind administration of Venlafaxine XR that occurred between months 7 - 12.
304295|NCT00183274|O1|Outcome|Open-Label: Venlafaxine XR|A 6-month open label administration of flexible dose Venlafaxine XR that occurred between months 1 - 6 of study.
304296|NCT00183274|E1|Reported Event|Venlafaxine XR|Adverse events were expected with venlafaxine XR. AEs were reported at least once by at least 5% of the study population for all patients who entered treatment. None of the adverse events that were expected or that occurred were considered serious or life threatening.
304297|NCT00170846|B4|Baseline|Total|Total of all reporting groups
328511|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
304299|NCT00170846|B2|Baseline|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
304300|NCT00170846|B1|Baseline|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
304301|NCT00170846|P3|Participant Flow|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
304302|NCT00170846|P2|Participant Flow|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
304303|NCT00170846|P1|Participant Flow|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
304304|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
304305|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
304306|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
304307|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
304308|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
304309|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
304310|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
304311|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
304312|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
304313|NCT00170846|E3|Reported Event|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
304314|NCT00170846|E2|Reported Event|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
304315|NCT00170846|E1|Reported Event|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
304316|NCT00170950|B3|Baseline|Total|Total of all reporting groups
304317|NCT00170950|B2|Baseline|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
304318|NCT00170950|B1|Baseline|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
304319|NCT00170950|P2|Participant Flow|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
304790|NCT00189475|P1|Participant Flow|Montelukast|"Treated for 4 months with montelukast 4 mg per day
Montelukast"
304320|NCT00170950|P1|Participant Flow|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
304321|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
304322|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
304323|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
304324|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
304325|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
304326|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
304327|NCT00170950|E2|Reported Event|Benazepril / HCTZ|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1), 40/12.5 mg (Dose Level 2), and 40/25 mg (Dose Level 3) capsules for oral administration once daily
304328|NCT00170950|E1|Reported Event|Benazepril / Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1), 40/5 mg (Dose Level 2), and 40/10 mg (Dose Level 3) capsules for oral administration once daily
304329|NCT00171054|B3|Baseline|Total|Total of all reporting groups
304330|NCT00171054|B2|Baseline|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304331|NCT00171054|B1|Baseline|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
306092|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
304332|NCT00171054|P2|Participant Flow|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304333|NCT00171054|P1|Participant Flow|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304334|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304335|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304336|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304337|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304338|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304339|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304340|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304341|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304342|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304343|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304344|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304345|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304346|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304347|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304348|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304349|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304350|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304351|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304352|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304353|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304354|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304355|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304356|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304357|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304358|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304359|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304360|NCT00171054|E2|Reported Event|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304361|NCT00171054|E1|Reported Event|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
304362|NCT00171210|B3|Baseline|Total|Total of all reporting groups
304363|NCT00171210|B2|Baseline|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304364|NCT00171210|B1|Baseline|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304767|NCT00189423|E1|Reported Event|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
304365|NCT00171210|P2|Participant Flow|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304366|NCT00171210|P1|Participant Flow|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304367|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304368|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304369|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304370|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304371|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304372|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304373|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304374|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304375|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304376|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304377|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304378|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304379|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304380|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304381|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304584|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
304382|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304383|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304384|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304385|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304386|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304387|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304388|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304389|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
304390|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304391|NCT00171210|E2|Reported Event|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
304392|NCT00171210|E1|Reported Event|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study continued this treatment in the extension study. Dosage based on body weight.
304393|NCT00171301|B3|Baseline|Total|Total of all reporting groups
304394|NCT00171301|B2|Baseline|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
304395|NCT00171301|B1|Baseline|Deferasirox (Between 2 <16 Years )|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
304768|NCT00189436|B3|Baseline|Total|Total of all reporting groups
304396|NCT00171301|P2|Participant Flow|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
304397|NCT00171301|P1|Participant Flow|Deferasirox (Between 2 <16 Years )|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
304398|NCT00171301|O1|Outcome|Deferasirox (All Participants)|Participants received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
304399|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
304400|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
304401|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
304402|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
304403|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
304404|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
304447|NCT00176826|B1|Baseline|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
304405|NCT00171301|E2|Reported Event|Deferasirox (16 Years or Older)|Participants age 16 years and older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
304406|NCT00171301|E1|Reported Event|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
304407|NCT00171314|B3|Baseline|Total|Total of all reporting groups
304408|NCT00171314|B2|Baseline|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304409|NCT00171314|B1|Baseline|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304410|NCT00171314|P2|Participant Flow|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304411|NCT00171314|P1|Participant Flow|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304412|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304413|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304414|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304415|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304461|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
304416|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304417|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304418|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304419|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304420|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304421|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304422|NCT00171314|E2|Reported Event|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304423|NCT00171314|E1|Reported Event|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1
304424|NCT00171340|B3|Baseline|Total|Total of all reporting groups
304425|NCT00171340|B2|Baseline|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304426|NCT00171340|B1|Baseline|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304581|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
304427|NCT00171340|P2|Participant Flow|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304428|NCT00171340|P1|Participant Flow|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304429|NCT00171340|O2|Outcome|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304430|NCT00171340|O1|Outcome|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304431|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
304432|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
304433|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
304434|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
304435|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
304436|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
304437|NCT00171340|O2|Outcome|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304438|NCT00171340|O1|Outcome|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304439|NCT00171340|E2|Reported Event|Zolendronic Acid 4mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304440|NCT00171340|E1|Reported Event|Zoledronic Acid 4mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1 and Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
304441|NCT00176800|B1|Baseline|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
304922|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304442|NCT00176800|P1|Participant Flow|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
304443|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
304444|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
304445|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
304446|NCT00176800|E1|Reported Event|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
304582|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
304448|NCT00176826|P1|Participant Flow|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
304449|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
304450|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
304451|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
304452|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
304453|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
304454|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
304455|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
304456|NCT00176826|E1|Reported Event|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
304457|NCT00176839|B1|Baseline|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
304458|NCT00176839|P1|Participant Flow|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
304459|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
304460|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
304923|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304462|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
304463|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
304464|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
304465|NCT00176839|E1|Reported Event|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
304466|NCT00176852|B4|Baseline|Total|Total of all reporting groups
304467|NCT00176852|B3|Baseline|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304468|NCT00176852|B2|Baseline|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304469|NCT00176852|B1|Baseline|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304470|NCT00176852|P3|Participant Flow|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304471|NCT00176852|P2|Participant Flow|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304472|NCT00176852|P1|Participant Flow|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304473|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304474|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304475|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304476|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304543|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304477|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304478|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304479|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304480|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304481|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304482|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304483|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304484|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304485|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304486|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304487|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304488|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304544|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304489|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304490|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304491|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304492|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304493|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304494|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304495|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304496|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304497|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304498|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304499|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304500|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304545|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304501|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304502|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304503|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304504|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304505|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304506|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304507|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304508|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304509|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304510|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304511|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304512|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304546|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304513|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304514|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304515|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304516|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304517|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304518|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304519|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304520|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304521|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304522|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304523|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304524|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304547|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304525|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304526|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304527|NCT00176852|E3|Reported Event|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.
Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304528|NCT00176852|E2|Reported Event|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.
Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
Total Body Irradiation: 300 cGY Day -1
Stem cell infusion: Given Day 0"
304529|NCT00176852|E1|Reported Event|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.
Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
304530|NCT00176865|B4|Baseline|Total|Total of all reporting groups
304531|NCT00176865|B3|Baseline|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304583|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
304532|NCT00176865|B2|Baseline|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304533|NCT00176865|B1|Baseline|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304534|NCT00176865|P3|Participant Flow|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304535|NCT00176865|P2|Participant Flow|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304536|NCT00176865|P1|Participant Flow|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304537|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304538|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304539|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304540|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304541|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304542|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
306093|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
304548|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304549|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304550|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304551|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304552|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304553|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304554|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304555|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304556|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304791|NCT00189475|O2|Outcome|Placebo|Treated for 6 days with placebo
304557|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304558|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304559|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304560|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304561|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304562|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304563|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304564|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304565|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304566|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304567|NCT00176865|E3|Reported Event|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304698|NCT00183677|P1|Participant Flow|Open Label Escitalopram|Participants will receive treatment with escitalopram.
304699|NCT00183677|O1|Outcome|Open Label Escitalopram|Participants received open treatment with escitalopram.
304568|NCT00176865|E2|Reported Event|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304569|NCT00176865|E1|Reported Event|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor
Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells
Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
304570|NCT00176878|B1|Baseline|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
304571|NCT00176878|P1|Participant Flow|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
304572|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
304573|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
304574|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
304575|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
304576|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
304577|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
304578|NCT00176878|E1|Reported Event|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
304579|NCT00176904|B1|Baseline|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
304580|NCT00176904|P1|Participant Flow|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
304585|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
304586|NCT00176904|E1|Reported Event|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
304587|NCT00176917|B1|Baseline|Transplant Patients|Patients that received hematopoietic stem cell transplant.
304588|NCT00176917|P1|Participant Flow|Transplant Patients|Patients that received hematopoietic stem cell transplant.
304589|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
304590|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
304591|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
304592|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
304593|NCT00176917|E1|Reported Event|Transplant Patients|Patients that received hematopoietic stem cell transplant.
304594|NCT00183339|B3|Baseline|Total|Total of all reporting groups
304595|NCT00183339|B2|Baseline|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
304596|NCT00183339|B1|Baseline|Placebo|Participants will take the placebo
304597|NCT00183339|P2|Participant Flow|Fluoxetine|Participants who received liquid fluoxetine 2-20 mg (of 4mg/1ml solution) in AM using a flexible dose strategy and planned 36 week titration schedule
304598|NCT00183339|P1|Participant Flow|Placebo|Participants who received placebo solution between .5ml and 5.0ml
304599|NCT00183339|O2|Outcome|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
304600|NCT00183339|O1|Outcome|Placebo|Participants will take the placebo
304601|NCT00183339|O2|Outcome|Fluoxetine|participants who were treated with flexible dose (2-20mg/D) fluoxetine solution
304602|NCT00183339|O1|Outcome|Placebo|participants who were treated with flexible dose placebo solution
304603|NCT00183339|O2|Outcome|Fluoxetine|Participants treated with flexible dose fluoxetine solution
304604|NCT00183339|O1|Outcome|Placebo|participants who were treated with flexible dose placebo solution
304605|NCT00183339|O2|Outcome|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
304606|NCT00183339|O1|Outcome|Placebo|Participants will take the placebo
304607|NCT00183339|E2|Reported Event|Fluoxetine|participants who were treated with flexible dose fluoxetine solution, 2-20mg per day
304608|NCT00183339|E1|Reported Event|Placebo|participants who were treated with flexible dose placebo solution
304609|NCT00183430|B3|Baseline|Total|Total of all reporting groups
304610|NCT00183430|B2|Baseline|Placebo|"Participants will receive treatment with placebo plus psychotherapy
Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
306094|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
304611|NCT00183430|B1|Baseline|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy
Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
304612|NCT00183430|P2|Participant Flow|Placebo|"Participants will receive treatment with placebo plus psychotherapy
Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
304613|NCT00183430|P1|Participant Flow|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy
Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
304614|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy
Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
304615|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy
Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
304616|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy
Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
304617|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy
Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
304618|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy
Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
304619|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy
Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
304620|NCT00183430|E2|Reported Event|Placebo|"Participants will receive treatment with placebo plus psychotherapy
Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
304621|NCT00183430|E1|Reported Event|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy
Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.
Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
304622|NCT00183456|B5|Baseline|Total|Total of all reporting groups
304623|NCT00183456|B4|Baseline|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304792|NCT00189475|O1|Outcome|Montelukast|Montelukast 10mg per day for 6 days
304793|NCT00189475|E2|Reported Event|Placebo|Treated for 4 months with placebo
304624|NCT00183456|B3|Baseline|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304625|NCT00183456|B2|Baseline|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304626|NCT00183456|B1|Baseline|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304627|NCT00183456|P4|Participant Flow|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304628|NCT00183456|P3|Participant Flow|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304629|NCT00183456|P2|Participant Flow|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304630|NCT00183456|P1|Participant Flow|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304631|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304632|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304633|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304634|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304635|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304700|NCT00183677|E1|Reported Event|Open Label Escitalopram|Participants will receive treatment with escitalopram.
304701|NCT00189098|B3|Baseline|Total|Total of all reporting groups
304636|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304637|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304638|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304639|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304640|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304641|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304642|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304643|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304644|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304645|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304646|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304647|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304673|NCT00183456|E2|Reported Event|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304648|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304649|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304650|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304651|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304652|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304653|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304654|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304655|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304656|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304657|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304658|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304659|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304660|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304661|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304662|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304663|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304664|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304665|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304666|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304667|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304668|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304669|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
304670|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304671|NCT00183456|E4|Reported Event|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
304672|NCT00183456|E3|Reported Event|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
304794|NCT00189475|E1|Reported Event|Montelukast|"Treated for 4 months with montelukast 4 mg per day
Montelukast"
304795|NCT00189488|B3|Baseline|Total|Total of all reporting groups
304674|NCT00183456|E1|Reported Event|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
304675|NCT00183469|B3|Baseline|Total|Total of all reporting groups
304676|NCT00183469|B2|Baseline|Lamotrigine Plus Placebo Divalproex ER|
304677|NCT00183469|B1|Baseline|Lamotrigine Plus Divalproex ER|Enrolled subjects received lamotrigine and divalproex ER
304678|NCT00183469|P2|Participant Flow|Double-Blind Lamotrigine and Placebo Divalproex ER|Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
304679|NCT00183469|P1|Participant Flow|Double-Blind Lamotrigine and Divalproex ER|Double blind randomized participants will take active lamotrigine and active divalproex Er
304680|NCT00183469|O2|Outcome|Double-Blind Lamotrigine and Placebo Divalproex ER|Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
304681|NCT00183469|O1|Outcome|Double-Blind Lamotrigine and Divalproex ER|Double blind randomized participants will take active lamotrigine and active divalproex Er
304682|NCT00183469|E2|Reported Event|Lamotrigine Plus Placebo Divalproex ER|randomized subjects will take active lamotrigine and placebo divalproex ER
304683|NCT00183469|E1|Reported Event|Lamotrigine Plus Active Divalproex ER|randomized participants will take active lamotrigine and active divalproex Er
304684|NCT00183625|B3|Baseline|Total|Total of all reporting groups
304685|NCT00183625|B2|Baseline|Olanzapine Treatment|
304686|NCT00183625|B1|Baseline|Risperidone Treatment|
304687|NCT00183625|P4|Participant Flow|Olanzapine + Supported Employment + Skills|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
304688|NCT00183625|P3|Participant Flow|Risperidone + Supported Employment + Skills|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
304689|NCT00183625|P2|Participant Flow|Olanzapine Plus Supported Employment|Individual Placement and Support plus Olanzapine. Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
304690|NCT00183625|P1|Participant Flow|Risperidone Plus Supported Employment|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
304691|NCT00183625|O2|Outcome|Olanzapine Treatment|
304692|NCT00183625|O1|Outcome|Risperidone Treatment|
304693|NCT00183625|O2|Outcome|Individual Placement and Support With Workplace Fundamentals|Olanzapine and Risperidone Patients included.
304694|NCT00183625|O1|Outcome|Individual Placement and Support (IPS)|IPS alone for risperidone and olanzapine subjects
304695|NCT00183625|E2|Reported Event|Olanzapine Treatment|
304696|NCT00183625|E1|Reported Event|Risperidone Treatment|
304697|NCT00183677|B1|Baseline|Open Label Escitalopram|Participants will receive treatment with escitalopram.
304702|NCT00189098|B2|Baseline|Sulfamethoxazole-trimethoprim|Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
304703|NCT00189098|B1|Baseline|Placebo|Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
304704|NCT00189098|P2|Participant Flow|Sulfamethoxazole-trimethoprim|Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
304733|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
304734|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
304735|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
304705|NCT00189098|P1|Participant Flow|Placebo|Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
304706|NCT00189098|O2|Outcome|Placebo|
304707|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
304708|NCT00189098|O2|Outcome|Placebo|
304709|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
304710|NCT00189098|O2|Outcome|Placebo|
304711|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
304712|NCT00189098|O2|Outcome|Placebo|
304713|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
304714|NCT00189098|O2|Outcome|Placebo|
304715|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
304716|NCT00189098|O2|Outcome|Placebo|The children in this group received placebo orally two times a day for 6 to 12 weeks.
304717|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|The children in this group received Sulfamethoxazole-trimethoprim orally (18 mg/kg, two times a day) for 6 to 12 weeks.
304718|NCT00189098|E2|Reported Event|Placebo|
304719|NCT00189098|E1|Reported Event|Sulfamethoxazole-trimethoprim|
304720|NCT00189137|B3|Baseline|Total|Total of all reporting groups
304721|NCT00189137|B2|Baseline|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
304722|NCT00189137|B1|Baseline|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
304723|NCT00189137|P2|Participant Flow|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
304724|NCT00189137|P1|Participant Flow|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
304725|NCT00189137|O2|Outcome|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
304726|NCT00189137|O1|Outcome|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
304727|NCT00189137|O2|Outcome|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
304728|NCT00189137|O1|Outcome|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
304729|NCT00189137|E2|Reported Event|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
304730|NCT00189137|E1|Reported Event|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
304731|NCT00189202|B1|Baseline|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
304732|NCT00189202|P1|Participant Flow|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
304736|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
304737|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
304738|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
304739|NCT00189202|E1|Reported Event|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
304740|NCT00189306|B1|Baseline|Aldara|Aldara (imiquimod) cream 5%
304741|NCT00189306|P1|Participant Flow|Aldara|Aldara (imiquimod) cream 5%
304742|NCT00189306|O1|Outcome|Aldara|Aldara (imiquimod) cream 5%
304743|NCT00189306|O1|Outcome|Aldara|Aldara (imiquimod) cream 5%
304744|NCT00189306|E1|Reported Event|Aldara|Aldara (imiquimod) cream 5%
304745|NCT00189423|B3|Baseline|Total|Total of all reporting groups
304746|NCT00189423|B2|Baseline|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
304747|NCT00189423|B1|Baseline|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
304748|NCT00189423|P2|Participant Flow|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
304749|NCT00189423|P1|Participant Flow|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
304750|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
304751|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
304752|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
304753|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
304754|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
304755|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
304756|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
304757|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
304758|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
304759|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
304760|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
304761|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
304762|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
304763|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
304764|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
304765|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
304769|NCT00189436|B2|Baseline|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.
Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
304770|NCT00189436|B1|Baseline|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
304771|NCT00189436|P2|Participant Flow|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.
Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
304772|NCT00189436|P1|Participant Flow|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
304773|NCT00189436|O2|Outcome|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.
Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
304774|NCT00189436|O1|Outcome|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
304775|NCT00189436|E2|Reported Event|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.
Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
304776|NCT00189436|E1|Reported Event|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
304777|NCT00189462|B3|Baseline|Total|Total of all reporting groups
304778|NCT00189462|B2|Baseline|Placebo|Treatment with placebo for 4 months
304779|NCT00189462|B1|Baseline|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)
Montelukast"
304780|NCT00189462|P2|Participant Flow|Placebo|Treatment with placebo for 4 months
304781|NCT00189462|P1|Participant Flow|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)
Montelukast"
304782|NCT00189462|O2|Outcome|Placebo|Treatment with placebo for 4 months
304783|NCT00189462|O1|Outcome|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)
Montelukast"
304784|NCT00189462|E2|Reported Event|Placebo|Treatment with placebo for 4 months
304785|NCT00189462|E1|Reported Event|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)
Montelukast"
304786|NCT00189475|B3|Baseline|Total|Total of all reporting groups
304796|NCT00189488|B2|Baseline|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
304797|NCT00189488|B1|Baseline|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
304798|NCT00189488|P2|Participant Flow|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. Participants received conditioning therapy starting at least 24 hours after the last 60 μg dose of palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the 180 μg/kg dose of palifermin on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively
304799|NCT00189488|P1|Participant Flow|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin once prior to transplant and at least 96 hours from the previous placebo dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively.
304800|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
304801|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
304802|NCT00189488|O2|Outcome|Palifermin|PaPalifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
304803|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
304804|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
304805|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
304806|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
304807|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
304808|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
304809|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
304810|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
304811|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
304812|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
304813|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
304814|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
304815|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
304816|NCT00189488|E2|Reported Event|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
304817|NCT00189488|E1|Reported Event|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
304818|NCT00189540|B3|Baseline|Total|Total of all reporting groups
304819|NCT00189540|B2|Baseline|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
304820|NCT00189540|B1|Baseline|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
304821|NCT00189540|P2|Participant Flow|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
304822|NCT00189540|P1|Participant Flow|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
304823|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
304824|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
304825|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
304826|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
304827|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
304828|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
304829|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
304830|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
304831|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
304832|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
304833|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
304834|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
304835|NCT00189540|E2|Reported Event|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
304836|NCT00189540|E1|Reported Event|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
304837|NCT00190671|B3|Baseline|Total|Total of all reporting groups
304838|NCT00190671|B2|Baseline|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304839|NCT00190671|B1|Baseline|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304840|NCT00190671|P2|Participant Flow|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304841|NCT00190671|P1|Participant Flow|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304842|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
306095|NCT00196105|E3|Reported Event|10 mm Wallstent|10 mm Stainless Steel Wallstent
304843|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304844|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304845|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304846|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304847|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304848|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304849|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304850|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304851|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304852|NCT00190671|O1|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304853|NCT00190671|O1|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304854|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304855|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304856|NCT00190671|E2|Reported Event|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304857|NCT00190671|E1|Reported Event|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
304858|NCT00190684|B1|Baseline|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304859|NCT00190684|P1|Participant Flow|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304860|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304861|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
310396|NCT00212264|O3|Outcome|Placebo Comparator|No treatment control
304862|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304863|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304864|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304865|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304866|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304867|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304868|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304869|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304870|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
328512|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
304871|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304872|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304873|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304874|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304875|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304876|NCT00190684|E1|Reported Event|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
304877|NCT00190749|B3|Baseline|Total|Total of all reporting groups
304878|NCT00190749|B2|Baseline|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304879|NCT00190749|B1|Baseline|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304880|NCT00190749|P2|Participant Flow|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304881|NCT00190749|P1|Participant Flow|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304882|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304883|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304884|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304885|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304886|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304887|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304888|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304889|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304890|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304891|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304892|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304893|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304894|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304895|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304896|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304897|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304898|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304899|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304900|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304901|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304902|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304903|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304904|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304905|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304906|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304907|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304908|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304909|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304910|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304911|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304912|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304913|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304914|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304915|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304916|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304917|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304918|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304919|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304920|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304921|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304924|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304925|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304926|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304927|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304928|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304929|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304930|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304931|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304932|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304933|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304934|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304935|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304936|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304937|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304938|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304939|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304940|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304941|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304942|NCT00190749|E2|Reported Event|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
304943|NCT00190749|E1|Reported Event|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
304944|NCT00190775|B3|Baseline|Total|Total of all reporting groups
304945|NCT00190775|B2|Baseline|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304946|NCT00190775|B1|Baseline|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304947|NCT00190775|P2|Participant Flow|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304948|NCT00190775|P1|Participant Flow|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304949|NCT00190775|O3|Outcome|Atomoxetine|Atomoxetine for 24 weeks
304950|NCT00190775|O2|Outcome|Placebo/Atomoxetine Group 2|Placebo for 24 weeks followed by atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
304951|NCT00190775|O1|Outcome|Placebo/Atomoxetine Group 1|Placebo for 24 Weeks followed by atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 11 days
304952|NCT00190775|O3|Outcome|Placebo|Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
304953|NCT00190775|O2|Outcome|Atomoxetine Group 2|Atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
304954|NCT00190775|O1|Outcome|Atomoxetine Group 1|Atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 11 days
304955|NCT00190775|O3|Outcome|Placebo|Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
304956|NCT00190775|O2|Outcome|Atomoxetine Group 2|Atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
304957|NCT00190775|O1|Outcome|Atomoxetine Group 1|Atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 4 days
304958|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304959|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304960|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304961|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304962|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304963|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304964|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304965|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
328513|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
304966|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304967|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304968|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304969|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304970|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304971|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304972|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304973|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304974|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304975|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304976|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304977|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304978|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304979|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304980|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304981|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304982|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304983|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304984|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304985|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304986|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304987|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304988|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304989|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304990|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304991|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304992|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304993|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304994|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304995|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304996|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304997|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
304998|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
304999|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
305000|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
305001|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
305002|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
305003|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
305004|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
305005|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
305006|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
305007|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
305008|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
305009|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
305010|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
305011|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
305012|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
305013|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
305014|NCT00190775|E2|Reported Event|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
305015|NCT00190775|E1|Reported Event|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
305016|NCT00190983|B1|Baseline|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
305017|NCT00190983|P1|Participant Flow|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
305141|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
305018|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
305019|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
305020|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
305021|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
305022|NCT00190983|E1|Reported Event|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
305023|NCT00191100|B3|Baseline|Total|Total of all reporting groups
305024|NCT00191100|B2|Baseline|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week"
305025|NCT00191100|B1|Baseline|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
305026|NCT00191100|P2|Participant Flow|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week"
305027|NCT00191100|P1|Participant Flow|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
305028|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week"
305029|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
305030|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week"
305031|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
305032|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week"
305066|NCT00191113|O1|Outcome|Treated-As-Randomized Control|Patients in As-Randomized Control group who at each observed time point remained untreated with growth hormone.
305068|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305033|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
305034|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week"
305035|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
305036|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week"
305037|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
305038|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week"
305039|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
305040|NCT00191100|E2|Reported Event|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week"
305041|NCT00191100|E1|Reported Event|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
305042|NCT00191113|B3|Baseline|Total|Total of all reporting groups
306096|NCT00196105|E2|Reported Event|10 mm Zilver|10 mm Nitinol Zilver Stent
305043|NCT00191113|B2|Baseline|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
305044|NCT00191113|B1|Baseline|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
305045|NCT00191113|P2|Participant Flow|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
305046|NCT00191113|P1|Participant Flow|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
305047|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
305048|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305049|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
305050|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305051|NCT00191113|O2|Outcome|Treated-As-Randomized Humatrope|Patients in the As-Randomized Humatrope group who received Humatrope
305052|NCT00191113|O1|Outcome|Treated-As-Randomized Control|Patients in As-Randomized Control group who at each observed time point remained untreated with growth hormone.
305053|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
305054|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305055|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
305056|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305057|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
305058|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305059|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
305060|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305061|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
305062|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305063|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
305064|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305065|NCT00191113|O2|Outcome|Treated-As-Randomized Humatrope|Patients in As-Randomized Humatrope group who received Humatrope treatment
305067|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
305069|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
305070|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305071|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
305072|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305073|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
305074|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305075|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
305076|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305077|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
305078|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305079|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
305080|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
305081|NCT00191113|O2|Outcome|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
305082|NCT00191113|O1|Outcome|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
305083|NCT00191113|E2|Reported Event|Treated-As-Randomized Humatrope|Patients in the As-Randomized Humatrope group who received Humatrope
305084|NCT00191113|E1|Reported Event|Treated-As-Randomized Control|Patients in the As-Randomized Control group who at each observed time point remained untreated with growth hormone.
305085|NCT00191139|B3|Baseline|Total|Total of all reporting groups
305086|NCT00191139|B2|Baseline|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
305087|NCT00191139|B1|Baseline|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
305088|NCT00191139|P2|Participant Flow|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
305089|NCT00191139|P1|Participant Flow|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
305090|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
305091|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
305092|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
305093|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
305094|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
305095|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
305096|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
305097|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
305098|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
305099|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
305100|NCT00191139|E2|Reported Event|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
305101|NCT00191139|E1|Reported Event|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
305102|NCT00191152|B3|Baseline|Total|Total of all reporting groups
306048|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305103|NCT00191152|B2|Baseline|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID),Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.
Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
305104|NCT00191152|B1|Baseline|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.
Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO)twice a day (BID), Days 1-14, every 21 days until progressive disease (PD) at which time all treatment is discontinued."
305105|NCT00191152|P2|Participant Flow|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.
Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
305106|NCT00191152|P1|Participant Flow|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2),intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.
Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued. PD during crossover was defined as the Response Evaluation Criteria in Solid Tumors (RECIST) guideline with the tumor measurement at the start of crossover treatment (or end of initial treatment) considered as the crossover baseline, with subsequent tumor measurements during crossover treatment compared to the crossover baseline."
305107|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
305108|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth twice day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
305109|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth, twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
305142|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
305110|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, on Day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
305111|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2 intravenously, days 1 and 8, every 21 days
305112|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14, every 21 days
305113|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
305114|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
305115|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
305116|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
305117|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
305118|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
305119|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
305120|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
305121|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
305122|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
305123|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
305124|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
305125|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.
305126|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|"gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.
Treatment continues until progression of disease at which time crossover treatment begins."
312130|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
305127|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
305128|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
305129|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
305130|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
305131|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
305132|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
305133|NCT00191152|E2|Reported Event|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.
Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
305134|NCT00191152|E1|Reported Event|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.
Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued."
305135|NCT00191165|B3|Baseline|Total|Total of all reporting groups
305136|NCT00191165|B2|Baseline|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
305137|NCT00191165|B1|Baseline|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
305138|NCT00191165|P2|Participant Flow|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
305139|NCT00191165|P1|Participant Flow|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
305140|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
305143|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
305144|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
305145|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
305146|NCT00191165|E2|Reported Event|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
305147|NCT00191165|E1|Reported Event|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
305148|NCT00191191|B3|Baseline|Total|Total of all reporting groups
305149|NCT00191191|B2|Baseline|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
305150|NCT00191191|B1|Baseline|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
305151|NCT00191191|P2|Participant Flow|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
305152|NCT00191191|P1|Participant Flow|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
305153|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
305154|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
305155|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
305156|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
305157|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
305158|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
305159|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
305160|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
305161|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
305162|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
305163|NCT00191191|E2|Reported Event|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
305164|NCT00191191|E1|Reported Event|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
305165|NCT00191269|B3|Baseline|Total|Total of all reporting groups
305166|NCT00191269|B2|Baseline|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305167|NCT00191269|B1|Baseline|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305168|NCT00191269|P2|Participant Flow|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305169|NCT00191269|P1|Participant Flow|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305170|NCT00191269|O1|Outcome|Dose Normalized to 1250 Milligrams Per Square Meter|12 participants with a mean gemcitabine dose of 1120 milligrams per square meter
305171|NCT00191269|O1|Outcome|Dose Normalized to 1250 Milligrams Per Square Meter|12 participants with a mean gemcitabine dose of 1120 milligrams per square meter
305172|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
312134|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
305173|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305174|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305175|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305176|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305177|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305178|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305179|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305180|NCT00191269|E2|Reported Event|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305181|NCT00191269|E1|Reported Event|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
305182|NCT00191282|B3|Baseline|Total|Total of all reporting groups
305183|NCT00191282|B2|Baseline|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305184|NCT00191282|B1|Baseline|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305185|NCT00191282|P2|Participant Flow|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305186|NCT00191282|P1|Participant Flow|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305187|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305188|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305189|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305190|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305191|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305192|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305193|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305194|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
306049|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305195|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305196|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305197|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305198|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305199|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305200|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305201|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305260|NCT00180271|B3|Baseline|Total|Total of all reporting groups
306097|NCT00196105|E1|Reported Event|6 mm Zilver|6 mm Nitinol Zilver Stent
305202|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305203|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305204|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305205|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305206|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305207|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305208|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305209|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305210|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305211|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305212|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305213|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305214|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305215|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305216|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305217|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305338|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
306098|NCT00196196|B1|Baseline|Codman VPV System|
305218|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305219|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305220|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305221|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305222|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305223|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305224|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305225|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305226|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305227|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305228|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305229|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305230|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305231|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305232|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305233|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305417|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305234|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305235|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305236|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305237|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305238|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305239|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305240|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305241|NCT00191282|E2|Reported Event|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
305242|NCT00191282|E1|Reported Event|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
305243|NCT00191308|B1|Baseline|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
305244|NCT00191308|P1|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
305245|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
305246|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
305247|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
305248|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
305249|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
305250|NCT00191308|E1|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
305251|NCT00179959|B3|Baseline|Total|Total of all reporting groups
305252|NCT00179959|B2|Baseline|Placebo|Intranasal petrolatum ointment treatment and plain water baths
305253|NCT00179959|B1|Baseline|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
305254|NCT00179959|P2|Participant Flow|Placebo|Intranasal petrolatum ointment treatment and plain water baths
305255|NCT00179959|P1|Participant Flow|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
305256|NCT00179959|O2|Outcome|Placebo|Intranasal petrolatum ointment treatment and plain water baths
305257|NCT00179959|O1|Outcome|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
305258|NCT00179959|E2|Reported Event|Placebo|Intranasal petrolatum ointment treatment and plain water baths
305259|NCT00179959|E1|Reported Event|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
305261|NCT00180271|B2|Baseline|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
305262|NCT00180271|B1|Baseline|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
305263|NCT00180271|P2|Participant Flow|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
305264|NCT00180271|P1|Participant Flow|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
305265|NCT00180271|O2|Outcome|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
305266|NCT00180271|O1|Outcome|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
305267|NCT00180271|E2|Reported Event|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
305268|NCT00180271|E1|Reported Event|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
305269|NCT00180323|B1|Baseline|Group 1|
305270|NCT00180323|P1|Participant Flow|Group 1|
305271|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
305272|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|6 minute walktest (6 MWT) was performed before implant (baseline ), 3months and 6 months Follow-up.
305273|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
305473|NCT00194675|B1|Baseline|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
305274|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
305275|NCT00180323|E1|Reported Event|Group 1|
305276|NCT00180479|B3|Baseline|Total|Total of all reporting groups
305277|NCT00180479|B2|Baseline|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305278|NCT00180479|B1|Baseline|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305279|NCT00180479|P2|Participant Flow|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305280|NCT00180479|P1|Participant Flow|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305281|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305282|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305283|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305284|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305285|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305286|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305287|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305288|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305289|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305290|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305291|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305292|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305293|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305294|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305295|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305296|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305297|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305298|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305299|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305300|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305301|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305302|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305303|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305304|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305305|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305306|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305307|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305308|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305309|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305310|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305311|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305312|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305313|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305314|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305315|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305316|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
314331|NCT00245102|O6|Outcome|Other Histology|Sorafenib 400 mg PO BID
305317|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305318|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305319|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305320|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305321|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305322|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305323|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305324|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305325|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305326|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305327|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305328|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305329|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305330|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305331|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305332|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305333|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305334|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305335|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305336|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305337|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305339|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305340|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305341|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305342|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305343|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305344|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305345|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305346|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305347|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305348|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305349|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305350|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305351|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305352|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305353|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305354|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305355|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305356|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305357|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305358|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305359|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305360|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305361|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305362|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305363|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305364|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305365|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305366|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305367|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305368|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305369|NCT00180479|E2|Reported Event|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
305370|NCT00180479|E1|Reported Event|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
305371|NCT00191334|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
305372|NCT00191334|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
305373|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
305374|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
305375|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
305376|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
306099|NCT00196196|P1|Participant Flow|Codman VPV System|
305377|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
305378|NCT00191334|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
305379|NCT00191386|B1|Baseline|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
305380|NCT00191386|P1|Participant Flow|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
305381|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
305382|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
305383|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
305384|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
305385|NCT00191386|E1|Reported Event|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
305386|NCT00191451|B4|Baseline|Total|Total of all reporting groups
305387|NCT00191451|B3|Baseline|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305388|NCT00191451|B2|Baseline|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305389|NCT00191451|B1|Baseline|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
306050|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305390|NCT00191451|P3|Participant Flow|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305391|NCT00191451|P2|Participant Flow|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305392|NCT00191451|P1|Participant Flow|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
305393|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305394|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305395|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
305396|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305397|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305398|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
305399|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305400|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305401|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
305402|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305403|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305404|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
305474|NCT00194675|P2|Participant Flow|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
306051|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305405|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305406|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305407|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
305408|NCT00191451|E3|Reported Event|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305409|NCT00191451|E2|Reported Event|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
305410|NCT00191451|E1|Reported Event|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.
Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
305411|NCT00191477|B3|Baseline|Total|Total of all reporting groups
305412|NCT00191477|B2|Baseline|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305413|NCT00191477|B1|Baseline|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305414|NCT00191477|P2|Participant Flow|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305415|NCT00191477|P1|Participant Flow|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305416|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
306019|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
305418|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305419|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305420|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305421|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305422|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305423|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305424|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305425|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305426|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305427|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
305428|NCT00191477|E2|Reported Event|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
305429|NCT00191477|E1|Reported Event|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
305430|NCT00191646|B3|Baseline|Total|Total of all reporting groups
305431|NCT00191646|B2|Baseline|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
305432|NCT00191646|B1|Baseline|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
305433|NCT00191646|P2|Participant Flow|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
305475|NCT00194675|P1|Participant Flow|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
305434|NCT00191646|P1|Participant Flow|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
305435|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
305436|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
305437|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
305438|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
305439|NCT00191646|O4|Outcome|Paclitaxel (Crossover)|Crossover (From Gemcitabine to Paclitaxel) - If no complete response on Gemcitabine, patient crossed over to receive Paclitaxel 175 mg/m^2, IV, day 1, q 21 days until complete response, disease progression or unacceptable toxicity
305440|NCT00191646|O3|Outcome|Gemcitabine (Crossover)|Crossover (From Paclitaxel to Gemcitabine) - If no complete response on Paclitaxel, patient crossed over to receive Gemcitabine 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
305441|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin (Induction)|Paclitaxel 175 milligrams per meter square (mg/m^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21-day cycles
305442|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin (Induction)|Gemcitabine 1000 milligrams per meter square (mg/m^2) Day 1, Day 8, Carboplatin AUC 5 Day 1, six 21-day cycles
305443|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
305444|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
305445|NCT00191646|E6|Reported Event|Crossover (Gemcitabine to Paclitaxel)|Single agent Paclitaxel 175mg/m2 IV Day 1 to be repeated every 21 days.
305446|NCT00191646|E5|Reported Event|Crossover (Paclitaxel to Gemcitabine)|Single agent Gemcitabine 1000mg/m2 IV, Day 1, Day 8 to be repeated every 21 days.
305447|NCT00191646|E4|Reported Event|Consolidation (Paclitaxel to Paclitaxel)|Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
305448|NCT00191646|E3|Reported Event|Consolidation (Gemcitabine to Paclitaxel)|Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
305449|NCT00191646|E2|Reported Event|Paclitaxel/Carboplatin Induction|Paclitaxel 175 milligrams per meter square (mg/m2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, 6 21 day cycles
305450|NCT00191646|E1|Reported Event|Gemcitabine/Carboplatin Induction|Gemcitabine 1000 milligrams per meter square (mg/m2) Day 1, Day 8, Carboplatin AUC 5 Day 1, 6 21 day cycles
305451|NCT00194532|B3|Baseline|Total|Total of all reporting groups
305452|NCT00194532|B2|Baseline|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
305453|NCT00194532|B1|Baseline|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
305454|NCT00194532|P2|Participant Flow|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
305455|NCT00194532|P1|Participant Flow|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
305456|NCT00194532|O2|Outcome|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
305457|NCT00194532|O1|Outcome|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
305458|NCT00194532|O2|Outcome|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
305459|NCT00194532|O1|Outcome|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
305460|NCT00194532|E2|Reported Event|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
305461|NCT00194532|E1|Reported Event|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
305462|NCT00194610|B3|Baseline|Total|Total of all reporting groups
305463|NCT00194610|B2|Baseline|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
305464|NCT00194610|B1|Baseline|Saline|Total 2 cc injected periurethrally
305465|NCT00194610|P2|Participant Flow|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
305466|NCT00194610|P1|Participant Flow|Saline|Total 2 cc injected periurethrally
305467|NCT00194610|O2|Outcome|Experimental Intervention: Botox|Botulinum toxin 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible, but not mandatory, injections of 25 IU in each of 2 trigger points.
305468|NCT00194610|O1|Outcome|Placebo : Saline|Saline 2 cc total injected periurethrally
305469|NCT00194610|E2|Reported Event|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
305470|NCT00194610|E1|Reported Event|Saline|Total 2 cc injected periurethrally
305471|NCT00194675|B3|Baseline|Total|Total of all reporting groups
305472|NCT00194675|B2|Baseline|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
305476|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
305477|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
305478|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% gel 7.5 daily + dutasteride 0.5 mg po daily
305479|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% gel 7.5 daily + oral placebo dutasteride daily
305480|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% gel 7.5 daily + dutasteride 0.5 mg po daily
305481|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% gel 7.5 daily + oral placebo dutasteride daily
305482|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
305483|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
305484|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
305485|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
305486|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
305487|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
305488|NCT00194675|E2|Reported Event|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
305489|NCT00194675|E1|Reported Event|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
305490|NCT00194792|B1|Baseline|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description
exemestane: Given PO
triptorelin pamoate: Given IM
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
paclitaxel: Given IV
therapeutic conventional surgery: Undergo lumpectomy or mastectomy
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
305491|NCT00194792|P1|Participant Flow|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description
exemestane: Given PO
triptorelin pamoate: Given IM
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
paclitaxel: Given IV
therapeutic conventional surgery: Undergo lumpectomy or mastectomy
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
305492|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description
exemestane: Given PO
triptorelin pamoate: Given IM
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
paclitaxel: Given IV
therapeutic conventional surgery: Undergo lumpectomy or mastectomy
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
305526|NCT00195013|O2|Outcome|Placebo|"10 grams three times a day (orally) for four days and then stop
Placebo: 10 grams three times a day (orally) for four days and then stop"
305493|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description
exemestane: Given PO
triptorelin pamoate: Given IM
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
paclitaxel: Given IV
therapeutic conventional surgery: Undergo lumpectomy or mastectomy
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
305494|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description
exemestane: Given PO
triptorelin pamoate: Given IM
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
paclitaxel: Given IV
therapeutic conventional surgery: Undergo lumpectomy or mastectomy
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
305495|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description
exemestane: Given PO
triptorelin pamoate: Given IM
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
paclitaxel: Given IV
therapeutic conventional surgery: Undergo lumpectomy or mastectomy
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
305496|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description
exemestane: Given PO
triptorelin pamoate: Given IM
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
paclitaxel: Given IV
therapeutic conventional surgery: Undergo lumpectomy or mastectomy
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
305497|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description
exemestane: Given PO
triptorelin pamoate: Given IM
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
paclitaxel: Given IV
therapeutic conventional surgery: Undergo lumpectomy or mastectomy
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
305498|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description
exemestane: Given PO
triptorelin pamoate: Given IM
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
paclitaxel: Given IV
therapeutic conventional surgery: Undergo lumpectomy or mastectomy
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
305499|NCT00194792|E1|Reported Event|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description
exemestane: Given PO
triptorelin pamoate: Given IM
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
paclitaxel: Given IV
therapeutic conventional surgery: Undergo lumpectomy or mastectomy
radiation therapy: Undergo radiation therapy
laboratory biomarker analysis: Correlative studies"
305500|NCT00194896|B5|Baseline|Total|Total of all reporting groups
305501|NCT00194896|B4|Baseline|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
305541|NCT00195260|P3|Participant Flow|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
306052|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305502|NCT00194896|B3|Baseline|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
305503|NCT00194896|B2|Baseline|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
305504|NCT00194896|B1|Baseline|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
305505|NCT00194896|P4|Participant Flow|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
305506|NCT00194896|P3|Participant Flow|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
305507|NCT00194896|P2|Participant Flow|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
305508|NCT00194896|P1|Participant Flow|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
305721|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
305509|NCT00194896|O4|Outcome|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
305510|NCT00194896|O3|Outcome|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
305511|NCT00194896|O2|Outcome|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
305512|NCT00194896|O1|Outcome|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
305513|NCT00194896|O4|Outcome|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
305514|NCT00194896|O3|Outcome|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
305576|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305515|NCT00194896|O2|Outcome|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
305516|NCT00194896|O1|Outcome|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
305517|NCT00194896|E4|Reported Event|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
305518|NCT00194896|E3|Reported Event|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
305519|NCT00194896|E2|Reported Event|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
305520|NCT00194896|E1|Reported Event|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
305521|NCT00195013|B3|Baseline|Total|Total of all reporting groups
305522|NCT00195013|B2|Baseline|Placebo|"10 grams three times a day (orally) for four days and then stop
Placebo: 10 grams three times a day (orally) for four days and then stop"
305523|NCT00195013|B1|Baseline|Glutamine|"10 grams three times a day (orally) for four days and then stop
glutamine: 10 grams three times a day (orally) for four days and then stop"
305524|NCT00195013|P2|Participant Flow|Placebo|"10 grams three times a day (orally) for four days and then stop
Placebo: 10 grams three times a day (orally) for four days and then stop"
305525|NCT00195013|P1|Participant Flow|Glutamine|"10 grams three times a day (orally) for four days and then stop
glutamine: 10 grams three times a day (orally) for four days and then stop"
306100|NCT00196196|O1|Outcome|Codman VPV System|
305527|NCT00195013|O1|Outcome|Glutamine|"10 grams three times a day (orally) for four days and then stop
glutamine: 10 grams three times a day (orally) for four days and then stop"
305528|NCT00195013|E2|Reported Event|Placebo|"10 grams three times a day (orally) for four days and then stop
Placebo: 10 grams three times a day (orally) for four days and then stop"
305529|NCT00195013|E1|Reported Event|Glutamine|"10 grams three times a day (orally) for four days and then stop
glutamine: 10 grams three times a day (orally) for four days and then stop"
305530|NCT00195260|B3|Baseline|Total|Total of all reporting groups
305531|NCT00195260|B2|Baseline|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305532|NCT00195260|B1|Baseline|Part 1|Participants received bosutinib capsule orally once daily continuously in 21-day cycles in dose escalation schemes of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in (500 mg) until disease progression, unacceptable toxicity, or consent withdrawal.
305533|NCT00195260|P11|Participant Flow|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305534|NCT00195260|P10|Participant Flow|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305535|NCT00195260|P9|Participant Flow|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305536|NCT00195260|P8|Participant Flow|Maximum Tolerated Dose (MTD) lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305537|NCT00195260|P7|Participant Flow|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305538|NCT00195260|P6|Participant Flow|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305539|NCT00195260|P5|Participant Flow|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305540|NCT00195260|P4|Participant Flow|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
306053|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305542|NCT00195260|P2|Participant Flow|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305543|NCT00195260|P1|Participant Flow|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305544|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305545|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305546|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305547|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305548|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305549|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305550|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305551|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305552|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305553|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305554|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
305555|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305556|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305557|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305558|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305559|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305560|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305561|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
305562|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305563|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305564|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305565|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305566|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305567|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305568|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
305569|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305570|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305571|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305572|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305573|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305574|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305575|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
306054|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305577|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305578|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305579|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305580|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305581|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305582|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305583|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305584|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305585|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305586|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305587|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305588|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305589|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305590|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305591|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305592|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305593|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
306101|NCT00196196|O1|Outcome|Codman VPV System|
305594|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305595|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305596|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305597|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305598|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305599|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305600|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305601|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305602|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305603|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305604|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305605|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305606|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305607|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305608|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305609|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305610|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305611|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305612|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305613|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305614|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305615|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305616|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305617|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305618|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305619|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305620|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305621|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305622|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305623|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305624|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305625|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305626|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305627|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
306102|NCT00196196|E1|Reported Event|Codman VPV System|
305628|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305629|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305630|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305631|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305632|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305633|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305634|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305635|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305636|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305637|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305638|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305639|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305640|NCT00195260|O1|Outcome|All Participant|All participants who received bosutinib capsule (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in) orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305641|NCT00195260|O1|Outcome|All Participant|All participants who received bosutinib capsule (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in) orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305642|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
314332|NCT00245102|O5|Outcome|Fibrosarcoma|Sorafenib 400 mg PO BID
305643|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305644|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305645|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305646|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305647|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305648|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305649|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305650|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305651|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305652|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305653|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305654|NCT00195260|O8|Outcome|MTD lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305655|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305656|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305657|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305658|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305659|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305660|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
306020|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
305661|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305662|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305663|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305664|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305665|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305666|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305667|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305668|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305669|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305670|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305671|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305672|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305673|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305674|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305675|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305676|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305677|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305678|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305679|NCT00195260|E9|Reported Event|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305680|NCT00195260|E8|Reported Event|MTD lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305681|NCT00195260|E7|Reported Event|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305682|NCT00195260|E6|Reported Event|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305683|NCT00195260|E5|Reported Event|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305684|NCT00195260|E4|Reported Event|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305685|NCT00195260|E3|Reported Event|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305686|NCT00195260|E2|Reported Event|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305687|NCT00195260|E1|Reported Event|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
305688|NCT00195273|B3|Baseline|Total|Total of all reporting groups
305689|NCT00195273|B2|Baseline|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305722|NCT00195351|E2|Reported Event|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
305723|NCT00195351|E1|Reported Event|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
305724|NCT00195403|B1|Baseline|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
305690|NCT00195273|B1|Baseline|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305691|NCT00195273|P2|Participant Flow|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305692|NCT00195273|P1|Participant Flow|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305742|NCT00195442|P1|Participant Flow|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305743|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305744|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305745|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305693|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305694|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305695|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305696|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305697|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305725|NCT00195403|P1|Participant Flow|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
305969|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305698|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305699|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305700|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305701|NCT00195273|E2|Reported Event|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305702|NCT00195273|E1|Reported Event|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
305703|NCT00195338|B1|Baseline|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
305704|NCT00195338|P1|Participant Flow|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
305705|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
305706|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
305707|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
305708|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
305709|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
305710|NCT00195338|E1|Reported Event|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
305711|NCT00195351|B3|Baseline|Total|Total of all reporting groups
305712|NCT00195351|B2|Baseline|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
305713|NCT00195351|B1|Baseline|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
305714|NCT00195351|P2|Participant Flow|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
305715|NCT00195351|P1|Participant Flow|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
305716|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
305717|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
305718|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
305719|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
305720|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
305726|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
305727|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
305728|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
305729|NCT00195403|E1|Reported Event|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
305730|NCT00195429|B3|Baseline|Total|Total of all reporting groups
305731|NCT00195429|B2|Baseline|Sirolimus + Prednisone|
305732|NCT00195429|B1|Baseline|Sirolimus + Tacrolimus|
305733|NCT00195429|P2|Participant Flow|Sirolimus + Prednisone|
305734|NCT00195429|P1|Participant Flow|Sirolimus + Tacrolimus|
305735|NCT00195429|O2|Outcome|Sirolimus + Prednisone|
305736|NCT00195429|O1|Outcome|Sirolimus + Tacrolimus|
305737|NCT00195429|O2|Outcome|Sirolimus + Prednisone|
305738|NCT00195429|O1|Outcome|Sirolimus + Tacrolimus|
305739|NCT00195429|E2|Reported Event|Sirolimus + Prednisone|
305740|NCT00195429|E1|Reported Event|Sirolimus + Tacrolimus|
305741|NCT00195442|B1|Baseline|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
306055|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305746|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305747|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305748|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305749|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305750|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305751|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305752|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305753|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305754|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305755|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305756|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305757|NCT00195442|E1|Reported Event|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
305758|NCT00195494|B3|Baseline|Total|Total of all reporting groups
305759|NCT00195494|B2|Baseline|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).
MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
305760|NCT00195494|B1|Baseline|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.
MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
305761|NCT00195494|P6|Participant Flow|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).
MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
305762|NCT00195494|P5|Participant Flow|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.
MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
305763|NCT00195494|P4|Participant Flow|Year 1 M / Year 2 M|"Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).
No reduction of MTX dose is permitted in year two."
305764|NCT00195494|P3|Participant Flow|Year 1 E+M / Year 2 E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
305966|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
306086|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
305765|NCT00195494|P2|Participant Flow|Year 1 M / Year 2 E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).
Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
305766|NCT00195494|P1|Participant Flow|Year 1 E+M / Year 2 E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).
Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
305767|NCT00195494|O6|Outcome|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).
MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
305768|NCT00195494|O5|Outcome|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.
MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
305769|NCT00195494|O4|Outcome|Year 2 M / M|"Following a blinded transition from year one- MTX dose consistent with the ending dose of year one (usually 20 mgs).
No reduction of MTX dose is permitted in year two."
305770|NCT00195494|O3|Outcome|Year 2 E+M / E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
305771|NCT00195494|O2|Outcome|Year 2 M / E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).
Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
305772|NCT00195494|O1|Outcome|Year 2 E+M / E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).
Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
305773|NCT00195494|O2|Outcome|Year 1 E+M|etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time
305774|NCT00195494|O1|Outcome|Year 1 M|Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
305775|NCT00195494|O2|Outcome|Year 1 E+M|etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time
305776|NCT00195494|O1|Outcome|Year 1 M|Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
305863|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305777|NCT00195494|E6|Reported Event|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).
MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
305778|NCT00195494|E5|Reported Event|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.
MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
305779|NCT00195494|E4|Reported Event|Year 1 M / Year 2 M|"Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).
No reduction of MTX dose is permitted in year two."
305780|NCT00195494|E3|Reported Event|Year 1 E+M / Year 2 E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
305781|NCT00195494|E2|Reported Event|Year 1 M / Year 2 E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).
Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
305782|NCT00195494|E1|Reported Event|Year 1 E+M / Year 2 E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).
Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
305783|NCT00195507|B3|Baseline|Total|Total of all reporting groups
305784|NCT00195507|B2|Baseline|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
305785|NCT00195507|B1|Baseline|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
305786|NCT00195507|P2|Participant Flow|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
305787|NCT00195507|P1|Participant Flow|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
305788|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
305789|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
305790|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
305791|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
305792|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
305793|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
305794|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
305795|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
306016|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
305796|NCT00195507|E2|Reported Event|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
305797|NCT00195507|E1|Reported Event|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
305798|NCT00195650|B1|Baseline|Adalimumab|Open-label adalimumab 40 mg
305799|NCT00195650|P1|Participant Flow|Adalimumab|Open-label adalimumab 40 mg
305800|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
305801|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
305802|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
305803|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
305804|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
305805|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
305806|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
305807|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
305808|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
305809|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
305810|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
305811|NCT00195650|E1|Reported Event|Adalimumab|Open-label adalimumab 40 mg
305812|NCT00195663|B4|Baseline|Total|Total of all reporting groups
305813|NCT00195663|B3|Baseline|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
305814|NCT00195663|B2|Baseline|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
305815|NCT00195663|B1|Baseline|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
306044|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305816|NCT00195663|P3|Participant Flow|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
305817|NCT00195663|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
305818|NCT00195663|P1|Participant Flow|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
305819|NCT00195663|O2|Outcome|Adalimumab: HAQ Decrease ≥ 0.5|Participants with a decrease of least 0.5 in HAQ from baseline, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
305820|NCT00195663|O1|Outcome|Adalimumab: HAQ Decrease ≥ 0.22|Participants with a decrease of least 0.22 in HAQ from baseline, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
305821|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
305822|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
305823|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
305824|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
305825|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
305826|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
305827|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
305967|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305828|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
305829|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
305830|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
305831|NCT00195663|O2|Outcome|Adalimumab: DAS28 < 3.2|Participants with a DAS28 score less than 3.2, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
305832|NCT00195663|O1|Outcome|Adalimumab: DAS28 < 2.6|Participants with a DAS28 score less than 2.6, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
305833|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
305834|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
305835|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
305836|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
306195|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
305837|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
305838|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305839|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305840|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305841|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305842|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305843|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305844|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305845|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305846|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305847|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305848|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305849|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305850|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305851|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305852|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
306017|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
305853|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305854|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305855|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305856|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305857|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305858|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305859|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305860|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305861|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305862|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
306045|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305864|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305865|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305866|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305867|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305868|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305869|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305870|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305871|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305872|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305873|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305874|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305875|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305876|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305877|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305878|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305879|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305880|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305881|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305882|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305883|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305884|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305885|NCT00195663|O1|Outcome|Methotrexate Weekly|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305886|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305887|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305888|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305889|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305890|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305891|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305892|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305893|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305894|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305895|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305896|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305897|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305898|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305899|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305900|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305901|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305902|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305903|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305904|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305905|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305906|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305907|NCT00195663|E4|Reported Event|Any Adalimumab|"Participants received either methotrexate, adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
Adverse events reported include those that occurred at any time during adalimumab exposure (up to 10 years)."
305908|NCT00195663|E3|Reported Event|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305909|NCT00195663|E2|Reported Event|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
305910|NCT00195663|E1|Reported Event|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
305911|NCT00195676|B1|Baseline|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
305912|NCT00195676|P1|Participant Flow|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
305913|NCT00195676|O1|Outcome|Period R Modified Intent-to-Treat Not Relapsed in Period W|A subset of the Period R modified Intent-to-Treat (mITT) population who had not relapsed (i.e., PGA not greater than or equal to 3) in Period W after adalimumab therapy was withdrawn.
305914|NCT00195676|O1|Outcome|Period R mITT Population Relapsed in Period W|A subset of the Period R modified Intent-to-Treat (mITT) population who had relapsed in Period W after adalimumab therapy was withdrawn.
305915|NCT00195676|O1|Outcome|Period W Modified Intent-to-treat Population|Participants from Period O who entered Period W with a PGA of 0 or 1 for the last 2 consecutive visits of Period O, at least 12 weeks apart, and received adalimumab 40 mg every other week for at least 12 weeks prior to entering Period W.
306046|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305916|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
305917|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
305918|NCT00195676|O1|Outcome|Period R Modified Intent-to-Treat Population|Participants of the Period W Modified Intent-to-Treat(mITT) Population who received at least one retreatment dose of adalimumab 40 mg every other week in Period R. The Period W mITT Population had entered Period W from Period O with stable psoriasis control [i.e., had a PGA of 0 or 1 at the last 2 consecutive visits in Period O, at least 12 weeks apart, and were on adalimumab 40 mg every other week for the last 12 weeks of Period O).
305919|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
305920|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
305921|NCT00195676|E1|Reported Event|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
305922|NCT00195702|B4|Baseline|Total|Total of all reporting groups
305923|NCT00195702|B3|Baseline|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305924|NCT00195702|B2|Baseline|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305925|NCT00195702|B1|Baseline|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305926|NCT00195702|P6|Participant Flow|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
305927|NCT00195702|P5|Participant Flow|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
305928|NCT00195702|P4|Participant Flow|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
305929|NCT00195702|P3|Participant Flow|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305930|NCT00195702|P2|Participant Flow|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305931|NCT00195702|P1|Participant Flow|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305968|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305932|NCT00195702|O3|Outcome|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo every week (ew) during the double-blind (DB) phase, followed by adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
305933|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, followed by adalimumab 40 mg eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
305934|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg every week (ew) during the double-blind (DB) phase, followed by adalimumab every other week (eow) during the open-label (OL) extension, along with concomitant methotrexate (MTX).
305935|NCT00195702|O3|Outcome|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo every week (ew) during the double-blind (DB) phase, followed by adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
305936|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, followed by adalimumab 40 mg eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
305937|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg every week (ew) during the double-blind (DB) phase, followed by adalimumab every other week (eow) during the open-label (OL) extension, along with concomitant methotrexate (MTX).
305938|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305939|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305940|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305941|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305942|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
306047|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
305943|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305944|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305945|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305946|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305947|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305948|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305949|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305950|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305951|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305952|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305953|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305954|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305955|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305956|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305957|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305958|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305959|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305960|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305961|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305962|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305963|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305964|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305965|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
306018|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
305970|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305971|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305972|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305973|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305974|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305975|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305976|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305977|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305978|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305979|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305980|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305981|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305982|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305983|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305984|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305985|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305986|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305987|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305988|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305989|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305990|NCT00195702|E4|Reported Event|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
305991|NCT00195702|E3|Reported Event|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305992|NCT00195702|E2|Reported Event|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
305993|NCT00195702|E1|Reported Event|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
305994|NCT00195715|B1|Baseline|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
305995|NCT00195715|P1|Participant Flow|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
305996|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
305997|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
305998|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
305999|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306000|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306001|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306002|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306003|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306004|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306005|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306006|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306007|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306008|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306009|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306010|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306011|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306012|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306013|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306014|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306015|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306021|NCT00195715|E1|Reported Event|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
306022|NCT00195819|B1|Baseline|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306023|NCT00195819|P2|Participant Flow|Any Adalimumab|40 mg every other week (eow), subcutaneous (SC)
306024|NCT00195819|P1|Participant Flow|Placebo 40 mg Every Other Week (Eow), Subcutaneous (SC)|
306025|NCT00195819|O1|Outcome|Any Adalimumab|By duration of exposure to adalimumab 40 mg every other week, subcutaneous
306026|NCT00195819|O2|Outcome|Placebo|(Week 52 - placebo plus up to 40 weeks of adalimumab)
306027|NCT00195819|O1|Outcome|Adalimumab Exposure|Adalimumab 40 mg every other week (eow)
306028|NCT00195819|O2|Outcome|Placebo|(Week 52 - Placebo plus up to 40 weeks adalimumab)
306029|NCT00195819|O1|Outcome|Adalimumab|Adalimumab every other week (eow)
306030|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306031|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306032|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306033|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306034|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306035|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306036|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306037|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306038|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306039|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306040|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306041|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306042|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306043|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306196|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
306056|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306057|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306058|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306059|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306060|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306061|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306062|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306063|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306064|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306065|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306066|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306067|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306068|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306069|NCT00195819|O1|Outcome|Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
306070|NCT00195819|O2|Outcome|Placebo|40 mg every other week, subcutaneous
306071|NCT00195819|O1|Outcome|Adalimumab|40 mg every other week, subcutaneous
306072|NCT00195819|E1|Reported Event|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
306073|NCT00196105|B4|Baseline|Total|Total of all reporting groups
306074|NCT00196105|B3|Baseline|10 mm Wallstent|10 mm Stainless Steel Wallstent
306075|NCT00196105|B2|Baseline|10 mm Zilver|10 mm Nitinol Zilver Stent
306076|NCT00196105|B1|Baseline|6 mm Zilver|6 mm Nitinol Zilver Stent
306077|NCT00196105|P3|Participant Flow|10 mm Wallstent|10 mm Stainless Steel Wallstent
306078|NCT00196105|P2|Participant Flow|10 mm Zilver|10 mm Nitinol Zilver Stent
306079|NCT00196105|P1|Participant Flow|6 mm Zilver|6 mm Nitinol Zilver Stent
306080|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
306081|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
306082|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
306083|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
306084|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
306085|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
306107|NCT00196313|P1|Participant Flow|Seasonique|"Seasonique
, 1 tablet daily"
306108|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
306109|NCT00196313|O1|Outcome|Seasonique|Seasonique, 1 tablet daily
306110|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
306111|NCT00196313|O1|Outcome|Seasonique|"Seasonique
, 1 tablet daily"
306112|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
306113|NCT00196313|O1|Outcome|Seasonique|Seasonique, 1 tablet daily
306114|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
306115|NCT00196313|O1|Outcome|Seasonique|"Seasonique
, 1 tablet daily"
306116|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
306117|NCT00196313|O1|Outcome|Seasonique|"Seasonique
, 1 tablet daily"
306118|NCT00196313|E2|Reported Event|Placebo|Placebo, 1 tablet daily
306119|NCT00196313|E1|Reported Event|Seasonique|"Seasonique
, 1 tablet daily"
306120|NCT00196326|B1|Baseline|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
306121|NCT00196326|P1|Participant Flow|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
306122|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
306123|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
306124|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
306125|NCT00196326|E1|Reported Event|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
306126|NCT00183729|B3|Baseline|Total|Total of all reporting groups
306127|NCT00183729|B2|Baseline|Placebo (2)|"Placebo for 12 weeks
Placebo: Placebo distribution is planned to mimic the active drug."
306128|NCT00183729|B1|Baseline|Memantine (1)|"Memantine for 12 weeks
Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
306129|NCT00183729|P2|Participant Flow|Placebo (2)|"Placebo for 12 weeks
Placebo: Placebo distribution is planned to mimic the active drug."
306130|NCT00183729|P1|Participant Flow|Memantine (1)|"Memantine for 12 weeks
Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
306131|NCT00183729|O2|Outcome|Placebo (2)|"Placebo for 12 weeks
Placebo: Placebo distribution is planned to mimic the active drug."
306132|NCT00183729|O1|Outcome|Memantine (1)|"Memantine for 12 weeks
Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
306133|NCT00183729|E2|Reported Event|Placebo (2)|"Placebo for 12 weeks
Placebo: Placebo distribution is planned to mimic the active drug."
306134|NCT00183729|E1|Reported Event|Memantine (1)|"Memantine for 12 weeks
Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
306135|NCT00183794|B1|Baseline|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
306136|NCT00183794|P1|Participant Flow|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
306197|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
306198|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
306137|NCT00183794|O1|Outcome|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
306138|NCT00183794|O1|Outcome|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
306139|NCT00183794|E1|Reported Event|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
306140|NCT00183963|B5|Baseline|Total|Total of all reporting groups
306141|NCT00183963|B4|Baseline|Arm 4: High Dose Fulvestrant|
306142|NCT00183963|B3|Baseline|Arm 3: Low Dose Fulvestrant|
306143|NCT00183963|B2|Baseline|Arm 2: Tamoxifen Group|
306144|NCT00183963|B1|Baseline|Arm 1: Control Group|
306145|NCT00183963|P4|Participant Flow|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg
Fulvestrant : 500mg given on day 1, administered by IM Injection"
306146|NCT00183963|P3|Participant Flow|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg
Fulvestrant : 250mg given on day 1, administered by IM Injection"
306147|NCT00183963|P2|Participant Flow|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg
Tamoxifen : 20mg daily, by mouth x 21 days"
306148|NCT00183963|P1|Participant Flow|Arm 1: Control Group|Placebo
306149|NCT00183963|O4|Outcome|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg
Fulvestrant : 500mg given on day 1, administered by IM Injection"
306150|NCT00183963|O3|Outcome|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg
Fulvestrant : 250mg given on day 1, administered by IM Injection"
306151|NCT00183963|O2|Outcome|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg
Tamoxifen : 20mg daily, by mouth x 21 days"
306152|NCT00183963|O1|Outcome|Arm 1: Control Group|Placebo
306153|NCT00183963|O4|Outcome|Arm 4: High Dose Fulvestrant|500 mg given on day 1, administered by IM Injection
306154|NCT00183963|O3|Outcome|Arm 3: Low Dose Fulvestrant|250 mg given on day 1, administered by IM Injection
306155|NCT00183963|O2|Outcome|Arm 2: Tamoxifen Group|20 mg given by mouth daily for 21 days
306156|NCT00183963|O1|Outcome|Arm 1: Control Group|Placebo
306157|NCT00183963|E4|Reported Event|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg
Fulvestrant : 500mg given on day 1, administered by IM Injection"
306158|NCT00183963|E3|Reported Event|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg
Fulvestrant : 250mg given on day 1, administered by IM Injection"
306159|NCT00183963|E2|Reported Event|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg
Tamoxifen : 20mg daily, by mouth x 21 days"
306160|NCT00183963|E1|Reported Event|Arm 1: Control Group|Placebo
306402|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
306403|NCT00186888|O1|Outcome|Baseline|At study entry.
306161|NCT00184002|B1|Baseline|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.
On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5
1 cycle = 21 days.
Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.
Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.
Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.
Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).
Prednisone 100 mg po days 1-5.
Cycle 2 until study completion
Doxil 40 mg/m2 iv day 1
Rituxan 375 mg/m2 iv day 1
Cyclophosphamide 750 mg/m2 iv day 1"
306162|NCT00184002|P1|Participant Flow|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.
On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5
1 cycle = 21 days.
Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.
Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.
Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.
Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).
Prednisone 100 mg po days 1-5.
Cycle 2 until study completion
Doxil 40 mg/m2 iv day 1
Rituxan 375 mg/m2 iv day 1
Cyclophosphamide 750 mg/m2 iv day 1"
306163|NCT00184002|O1|Outcome|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.
On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5
1 cycle = 21 days.
Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.
Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.
Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.
Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).
Prednisone 100 mg po days 1-5.
Cycle 2 until study completion
Doxil 40 mg/m2 iv day 1
Rituxan 375 mg/m2 iv day 1
Cyclophosphamide 750 mg/m2 iv day 1"
306164|NCT00184002|O1|Outcome|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.
On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5
1 cycle = 21 days.
Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.
Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.
Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.
Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).
Prednisone 100 mg po days 1-5.
Cycle 2 until study completion
Doxil 40 mg/m2 iv day 1
Rituxan 375 mg/m2 iv day 1
Cyclophosphamide 750 mg/m2 iv day 1"
306199|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
306200|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
306201|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
306202|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
306165|NCT00184002|E1|Reported Event|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.
On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5
1 cycle = 21 days.
Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.
Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5.
Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1"
306166|NCT00184028|B1|Baseline|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
306167|NCT00184028|P1|Participant Flow|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
306168|NCT00184028|O1|Outcome|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
306169|NCT00184028|O1|Outcome|Arm 1|Single arm study
306170|NCT00184028|E1|Reported Event|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
306171|NCT00184054|B1|Baseline|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
306172|NCT00184054|P1|Participant Flow|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
306173|NCT00184054|O1|Outcome|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
306174|NCT00184054|O1|Outcome|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
306175|NCT00184054|E1|Reported Event|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
306176|NCT00184093|B1|Baseline|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation
Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
306177|NCT00184093|P1|Participant Flow|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation
Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
306178|NCT00184093|O1|Outcome|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation
Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
306179|NCT00184093|O1|Outcome|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation
Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
306180|NCT00184093|E1|Reported Event|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation
Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
306181|NCT00184548|B5|Baseline|Total|Total of all reporting groups
306182|NCT00184548|B4|Baseline|Placebo, Penetrating Trauma|
306183|NCT00184548|B3|Baseline|rFVIIa, Penetrating Trauma|
306184|NCT00184548|B2|Baseline|Placebo, Blunt Trauma|
306185|NCT00184548|B1|Baseline|rFVIIa, Blunt Trauma|
306186|NCT00184548|P4|Participant Flow|Placebo, Penetrating Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
306187|NCT00184548|P3|Participant Flow|rVIIa, Penetrating Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
306188|NCT00184548|P2|Participant Flow|Placebo, Blunt Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
306189|NCT00184548|P1|Participant Flow|rFVIIa, Blunt Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
306190|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
306191|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
306192|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
306193|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
306194|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
306218|NCT00184548|E4|Reported Event|Placebo, Penetrating Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
306219|NCT00184548|E3|Reported Event|rVIIa, Penetrating Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
306220|NCT00184548|E2|Reported Event|Placebo, Blunt Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
306221|NCT00184548|E1|Reported Event|rFVIIa, Blunt Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
306222|NCT00184600|B4|Baseline|Total|Total of all reporting groups
306291|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306223|NCT00184600|B3|Baseline|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306224|NCT00184600|B2|Baseline|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306225|NCT00184600|B1|Baseline|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306226|NCT00184600|P3|Participant Flow|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306227|NCT00184600|P2|Participant Flow|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306228|NCT00184600|P1|Participant Flow|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306352|NCT00186537|E1|Reported Event|Fenofibrate|"160 mg daily for 12 weeks
Fenofibrate"
306353|NCT00186875|B3|Baseline|Total|Total of all reporting groups
306229|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306230|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306285|NCT00184717|P1|Participant Flow|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306395|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
306396|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
306231|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306232|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306233|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306234|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306235|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306236|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306237|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306238|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306286|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306397|NCT00186888|O1|Outcome|Baseline|At study entry.
306239|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306240|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306241|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306242|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306243|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306244|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306245|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306246|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306287|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306398|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
306247|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306248|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306249|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306250|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306251|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306252|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306253|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306254|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306288|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306399|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
306400|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
306255|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306256|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306257|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306258|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306259|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306260|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306261|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306262|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306289|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
328514|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
306263|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306264|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306265|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306266|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306267|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306268|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306269|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306270|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306290|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306401|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
306271|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306272|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306273|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306274|NCT00184600|E3|Reported Event|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
306275|NCT00184600|E2|Reported Event|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
306276|NCT00184600|E1|Reported Event|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
306278|NCT00184717|B3|Baseline|No Treatment|No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
306279|NCT00184717|B2|Baseline|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306280|NCT00184717|B1|Baseline|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306281|NCT00184717|P5|Participant Flow|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306282|NCT00184717|P4|Participant Flow|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306283|NCT00184717|P3|Participant Flow|No Treatment|No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
306284|NCT00184717|P2|Participant Flow|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306292|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306293|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306294|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306295|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306296|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306297|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306298|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306299|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306300|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306301|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306302|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306303|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306304|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306305|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306306|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306307|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306308|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306309|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306310|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306311|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306312|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306313|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306314|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306315|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
306316|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306317|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
306318|NCT00184717|E4|Reported Event|0.067 mg / No Treatment|
306319|NCT00184717|E3|Reported Event|0.033 mg / No Treatment|
306320|NCT00184717|E2|Reported Event|0.067 mg / NN-220|
306321|NCT00184717|E1|Reported Event|0.033 mg / NN-220|
306322|NCT00186446|B1|Baseline|Bupropion and Smoking Cessation Behavioral Intervention|
306323|NCT00186446|P1|Participant Flow|Bupropion and Smoking Cessation Behavioral Intervention|Medication for depression and behavioral intervention for smoking cessation
306324|NCT00186446|O1|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|bupropion and behavioral intervention
306325|NCT00186446|O1|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|Medication for depression and behavioral intervention for smoking cessation
306326|NCT00186446|O1|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|
306327|NCT00186446|E1|Reported Event|Bupropion and Smoking Cessation Behavioral Intervention|
306328|NCT00186485|B1|Baseline|Right Sided Low Frequency Unilateral TMS|"Open treatment with 1Hz unilateral TMS delivered to the right DLPFC using the MagStim device
MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
306329|NCT00186485|P1|Participant Flow|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device
MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
306330|NCT00186485|O1|Outcome|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device
MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
306331|NCT00186485|O1|Outcome|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device
MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
306332|NCT00186485|O1|Outcome|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device
MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
306333|NCT00186485|E1|Reported Event|Right Sided Low Frequency Unilateral TMS|"Open treatment with 1Hz unilateral TMS delivered to the right DLPFC using the MagStim device
MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
306334|NCT00186537|B4|Baseline|Total|Total of all reporting groups
306335|NCT00186537|B3|Baseline|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks
Weight Loss"
306336|NCT00186537|B2|Baseline|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks
Rosiglitazone"
306337|NCT00186537|B1|Baseline|Fenofibrate|"160 mg daily for 12 weeks
Fenofibrate"
306338|NCT00186537|P3|Participant Flow|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks
Weight Loss"
306339|NCT00186537|P2|Participant Flow|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks
Rosiglitazone"
306340|NCT00186537|P1|Participant Flow|Fenofibrate|"160 mg daily for 12 weeks
Fenofibrate"
306341|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks
Weight Loss"
306342|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks
Rosiglitazone"
306343|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks
Fenofibrate"
306344|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks
Weight Loss"
306345|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks
Rosiglitazone"
306346|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks
Fenofibrate"
306347|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks
Weight Loss"
306348|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks
Rosiglitazone"
306349|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks
Fenofibrate"
306350|NCT00186537|E3|Reported Event|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks
Weight Loss"
306351|NCT00186537|E2|Reported Event|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks
Rosiglitazone"
315128|NCT00248170|B1|Baseline|Letrozole|2.5 mg by mouth (p.o.) once daily
306354|NCT00186875|B2|Baseline|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
306355|NCT00186875|B1|Baseline|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
306356|NCT00186875|P2|Participant Flow|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
306357|NCT00186875|P1|Participant Flow|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
306358|NCT00186875|O3|Outcome|TOTXV Participants|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy. Participants received high-dose methotrexate infusion in upfront window treatment as described in NCT00137111.
306359|NCT00186875|O2|Outcome|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
306360|NCT00186875|O1|Outcome|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
306361|NCT00186875|O3|Outcome|TOTXV Participants|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy. Participants received high-dose methotrexate infusion in upfront window treatment as described in NCT00137111.
306362|NCT00186875|O2|Outcome|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
306363|NCT00186875|O1|Outcome|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
306364|NCT00186875|O2|Outcome|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
306365|NCT00186875|O1|Outcome|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
306366|NCT00186875|O2|Outcome|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
306367|NCT00186875|O1|Outcome|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
306368|NCT00186875|E2|Reported Event|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
306369|NCT00186875|E1|Reported Event|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
306370|NCT00186888|B4|Baseline|Total|Total of all reporting groups
306371|NCT00186888|B3|Baseline|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
306372|NCT00186888|B2|Baseline|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306373|NCT00186888|B1|Baseline|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
306374|NCT00186888|P3|Participant Flow|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
306375|NCT00186888|P2|Participant Flow|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306442|NCT00186901|B1|Baseline|Placebo Group|Nutritional counseling + placebo
306443|NCT00186901|P3|Participant Flow|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
315129|NCT00248170|P2|Participant Flow|Anastrozole|1 mg p.o. once daily
306376|NCT00186888|P1|Participant Flow|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
306377|NCT00186888|O1|Outcome|5 Years|Participant age was 5 years ±3 months.
306378|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
306379|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
306380|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
306381|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
306382|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
306383|NCT00186888|O1|Outcome|Baseline|At study entry.
306384|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
306385|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
306386|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
306387|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
306388|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
306389|NCT00186888|O1|Outcome|Baseline|At study entry.
306390|NCT00186888|O2|Outcome|Occupational Therapy Did Not Recommend Rehabilitation Services|Occupational therapy evaluation did not recommend rehabilitation services.
306391|NCT00186888|O1|Outcome|Occupational Therapy Recommended Rehabilitation Services|Occupational therapy evaluation recommended rehabilitation services.
306392|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
306393|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
306394|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
306404|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306405|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306406|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306407|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306408|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306409|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306410|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306423|NCT00186888|O1|Outcome|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
307186|NCT00201006|P2|Participant Flow|Telephone Counseling|26 biweekly telephone counseling sessions
306411|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306412|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306413|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306414|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
The patients were re-classified into 2 groups of early (IC=A and B) and advanced (IC=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306458|NCT00186901|O2|Outcome|Placebo - (DXA)|39 of the 91 patients assessed at 24 months also had a DXA scan.
306459|NCT00186901|O1|Outcome|Placebo - (QCT)|91 patients were assessed at 24 months using the QCT scan.
306415|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306416|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306417|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306418|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306419|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
306420|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306421|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306422|NCT00186888|O1|Outcome|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
315410|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
306424|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306425|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306426|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306427|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306428|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306460|NCT00186901|O4|Outcome|Supplement - (DXA)|47 of the 109 patients assessed at 12 months also had a DXA scan.
306461|NCT00186901|O3|Outcome|Supplement - (QCT)|109 patients were assessed at 12 months using the QCT scan.
306429|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306430|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306431|NCT00186888|O1|Outcome|Stratum B|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
Two patients (3 eyes) in stratum B received external beam radiation therapy (EBRT), and the same 2 patients later required enucleation of the treated eye, thus the failure (event number) and censoring status were not changed for the 2 patients."
306432|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306433|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306434|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306435|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306436|NCT00186888|E3|Reported Event|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
306437|NCT00186888|E2|Reported Event|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
306438|NCT00186888|E1|Reported Event|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
306439|NCT00186901|B4|Baseline|Total|Total of all reporting groups
306440|NCT00186901|B3|Baseline|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
306441|NCT00186901|B2|Baseline|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
306444|NCT00186901|P2|Participant Flow|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
306445|NCT00186901|P1|Participant Flow|Placebo Group|Nutritional counseling + placebo
306446|NCT00186901|O3|Outcome|Bsm - bb Genotype|The bb genotype was observed in 77 (18.47%) out of 417 participants, with a median BMD Z score of -0.17.
306447|NCT00186901|O2|Outcome|Bsm - Bb Genotype|The Bb genotype was observed in 65 (15.59%) out of 417 participants, with a median BMD Z score of -0.17.
306448|NCT00186901|O1|Outcome|Bsm - BB Genotype|The BB genotype was observed in 41 (09.83%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.5.
306449|NCT00186901|O3|Outcome|Apa 1 - aa Genotype|The aa genotype was present in 49 (11.75%) out of 417 participants, with a median BMD Z score of -0.57.
306450|NCT00186901|O2|Outcome|Apa 1 - Aa Genotype|The Aa genotype was observed in 104 (24.94%) out of 417 participants, with a median BMD Z score of -0.44.
306451|NCT00186901|O1|Outcome|Apa 1 - AA Genotype|The AA genotype was observed in 68 (16.31%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.56.
306452|NCT00186901|O4|Outcome|Supplement - (DXA)|53 of the 96 patients assessed at 36 months also had a DXA scan.
306453|NCT00186901|O3|Outcome|Supplement - (QCT)|96 patients were assessed at 36 months using the QCT scan.
306454|NCT00186901|O2|Outcome|Placebo - (DXA)|36 of the 84 patients assessed at 36 months also had a DXA scan.
306455|NCT00186901|O1|Outcome|Placebo - (QCT)|84 patients were assessed at 36 months using the QCT scan.
306456|NCT00186901|O4|Outcome|Supplement - (DXA)|51 of the 97 patients assessed at 24 months also had a DXA scan.
306457|NCT00186901|O3|Outcome|Supplement - (QCT)|97 patients were assessed at 24 months using the QCT scan.
306462|NCT00186901|O2|Outcome|Placebo - (DXA)|47 of the 109 patients assessed at 12 months also had a DXA scan.
306463|NCT00186901|O1|Outcome|Placebo - (QCT)|109 patients were assessed at 12 months using the QCT scan.
306464|NCT00186901|O4|Outcome|Supplement - (DXA)|61 of the 141 baseline patients also had a DXA scan.
306465|NCT00186901|O3|Outcome|Supplement - (QCT)|141 patients were assessed at baseline using the QCT scan.
306466|NCT00186901|O2|Outcome|Placebo - (DXA)|60 of the 134 baseline patients also had a DXA scan.
306467|NCT00186901|O1|Outcome|Placebo - (QCT)|134 patients were assessed at baseline using the QCT scan.
306468|NCT00186901|O4|Outcome|Above 22 Years|113 patients greater than 22 years of age were eligible for the study
306469|NCT00186901|O3|Outcome|18 to 22 Years|74 patients between the ages of 18 and 22 were eligible for the study
306470|NCT00186901|O2|Outcome|13 to 18 Years|139 patients between the ages of 13 and 18 were eligible for the study
306471|NCT00186901|O1|Outcome|9 to 13 Years|98 patients between the ages of 9 and 13 were eligible for the study
306472|NCT00186901|O2|Outcome|Non-white|59 non-white were eligible for the study
306473|NCT00186901|O1|Outcome|White|365 white patients were eligible for the study
306474|NCT00186901|O2|Outcome|Female|206 females were eligible for the study
306475|NCT00186901|O1|Outcome|Male|218 males were eligible for the study
306476|NCT00186901|O2|Outcome|Supplement|CVD Supplement Group (Experimental 1B): Patients who received calcium and vitamin D supplementation.
306477|NCT00186901|O1|Outcome|Placebo|Placebo Group (Placebo Comparator 1A): Patients who received placebo pills.
306478|NCT00186901|E3|Reported Event|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
306479|NCT00186901|E2|Reported Event|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
306480|NCT00186901|E1|Reported Event|Placebo Group|Nutritional counseling + placebo
306481|NCT00187096|B4|Baseline|Total|Total of all reporting groups
306482|NCT00187096|B3|Baseline|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2.0 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306483|NCT00187096|B2|Baseline|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306484|NCT00187096|B1|Baseline|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Arm 1 participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306485|NCT00187096|P3|Participant Flow|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2.0 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306486|NCT00187096|P2|Participant Flow|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306487|NCT00187096|P1|Participant Flow|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|Participants with AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Arm 1 participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306488|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306547|NCT00187135|O2|Outcome|Fentanyl 0.5mcg/kg vs Placebo|Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.
306489|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).
Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.
Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
306490|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306491|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306492|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).
Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.
Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
306565|NCT00187200|E2|Reported Event|Sequential VV Pacing|V-V delay was optimized
306566|NCT00187200|E1|Reported Event|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
306493|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306494|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306495|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).
Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.
Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
306496|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306497|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306498|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).
Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.
Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
306499|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306500|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306501|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).
Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.
Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
306502|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306548|NCT00187135|O1|Outcome|Fentanyl 1mcg/kg vs Placebo|Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.
307187|NCT00201006|P1|Participant Flow|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
306503|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306504|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).
Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.
Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
306505|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306506|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306507|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).
Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.
Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
306567|NCT00187226|B7|Baseline|Total|Total of all reporting groups
306508|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306509|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306510|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).
Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.
Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
306511|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306512|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306513|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).
Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.
Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
306514|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306515|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306516|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).
Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.
Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
306517|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306518|NCT00187096|E3|Reported Event|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
306519|NCT00187096|E2|Reported Event|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).
Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.
Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
306520|NCT00187096|E1|Reported Event|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
306521|NCT00187135|B7|Baseline|Total|Total of all reporting groups
306522|NCT00187135|B6|Baseline|Fentanyl 1/Placebo/Fentanyl 0.5|
306523|NCT00187135|B5|Baseline|Fentanyl 1/Fentanyl 0.5/Placebo|
306524|NCT00187135|B4|Baseline|Placebo/Fentanyl 1/Fentanyl 0.5|
306525|NCT00187135|B3|Baseline|Placebo/Fentanyl 0.5/Fentanyl 1|
306526|NCT00187135|B2|Baseline|Fentanyl 0.5/Fentanyl 1/Placebo|
306527|NCT00187135|B1|Baseline|Fentanyl 0.5/Placebo/Fentanyl 1|
306528|NCT00187135|P6|Participant Flow|Fentanyl 1 / Placebo /Fentanyl 0.5|Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Placebo during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.
306529|NCT00187135|P5|Participant Flow|Fentanyl 1 / Fentanyl 0.5 / Placebo|Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
306530|NCT00187135|P4|Participant Flow|Placebo /Fentanyl 1 / Fentanyl 0.5|Participants assigned to receive Placebo during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.
306531|NCT00187135|P3|Participant Flow|Placebo / Fentanyl 0.5 /Fentanyl 1|Participants assigned to receive Placebo during their first visit, Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 1 micrograms per kilogram (mcg/kg) at the final visit.
306532|NCT00187135|P2|Participant Flow|Fentanyl 0.5 /Fentanyl 1 / Placebo|Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
306533|NCT00187135|P1|Participant Flow|Fentanyl 0.5 / Placebo / Fentanyl 1|Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Placebo (Pl)during their second visit, and Fentanyl 1 micrograms per kilogram at the final visit.
306534|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm.
306535|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
306536|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
306537|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm.
306538|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
306539|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
306540|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
306541|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
306542|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
306543|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
306544|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
306545|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
306546|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg vs Fentanyl 1mcg/kg|Patients who completed treatment with Fentanyl 0.5 mcg/kg and Fentanyl 1mcg/kg.
306549|NCT00187135|E3|Reported Event|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
306550|NCT00187135|E2|Reported Event|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1.0 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
306551|NCT00187135|E1|Reported Event|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
306552|NCT00187200|B3|Baseline|Total|Total of all reporting groups
306553|NCT00187200|B2|Baseline|Sequential VV Pacing|V-V delay was optimized
306554|NCT00187200|B1|Baseline|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
306555|NCT00187200|P2|Participant Flow|Sequential VV Pacing|V-V delay was optimized
306556|NCT00187200|P1|Participant Flow|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
306557|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
306558|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
306559|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
306560|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
306561|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
306562|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
306563|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized per protocol
306564|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay per protocol
306568|NCT00187226|B6|Baseline|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
306569|NCT00187226|B5|Baseline|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
306570|NCT00187226|B4|Baseline|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
306571|NCT00187226|B3|Baseline|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
306572|NCT00187226|B2|Baseline|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
306573|NCT00187226|B1|Baseline|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
306574|NCT00187226|P6|Participant Flow|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
306575|NCT00187226|P5|Participant Flow|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
306576|NCT00187226|P4|Participant Flow|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
306577|NCT00187226|P3|Participant Flow|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
306578|NCT00187226|P2|Participant Flow|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
306579|NCT00187226|P1|Participant Flow|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
306580|NCT00187226|O6|Outcome|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
306581|NCT00187226|O5|Outcome|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
306582|NCT00187226|O4|Outcome|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
306583|NCT00187226|O3|Outcome|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
306584|NCT00187226|O2|Outcome|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
306585|NCT00187226|O1|Outcome|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
306586|NCT00187226|E6|Reported Event|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
306587|NCT00187226|E5|Reported Event|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
306588|NCT00187226|E4|Reported Event|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
306589|NCT00187226|E3|Reported Event|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
306590|NCT00187226|E2|Reported Event|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
306591|NCT00187226|E1|Reported Event|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
306592|NCT00187486|B1|Baseline|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
306593|NCT00187486|P1|Participant Flow|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
306594|NCT00187486|O1|Outcome|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
307118|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
306595|NCT00187486|O1|Outcome|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
306596|NCT00187486|E1|Reported Event|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
306597|NCT00187655|B1|Baseline|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
306598|NCT00187655|P1|Participant Flow|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
306599|NCT00187655|O2|Outcome|Homozygous for OAT3-Ile305Phe Variant|2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as homozygous for the Ile305Phe variant and compared to volunteers that were heterozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.
306600|NCT00187655|O1|Outcome|Heterozygous for the Ile305Phe Variant|2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as heterozygous for the Ile305Phe variant and compared to volunteers that were homozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.
306601|NCT00187655|E1|Reported Event|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
306602|NCT00187681|B3|Baseline|Total|Total of all reporting groups
306603|NCT00187681|B2|Baseline|OCT1-reference Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
306604|NCT00187681|B1|Baseline|OCT1-variant Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
306605|NCT00187681|P2|Participant Flow|Organic Cation Transporter 1 (OCT1)-Reference Group|Subjects with OCT1-reference alleles to be dosed with 2 doses of Metformin (total 1850 mg).
306606|NCT00187681|P1|Participant Flow|Organic Cation Transporter 1 (OCT1)-Variant Group|Subjects with OCT1-variant alleles to be dosed with 2 doses of Metformin (total 1850 mg).
328515|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
306607|NCT00187681|O2|Outcome|OCT1-reference Group|Glucose lowering response to metformin (Glucose AUC) in subjects carrying the reference OCT1 genotype at all the four positions in the OCT1 gene.
306608|NCT00187681|O1|Outcome|OCT1-variant Group|Glucose lowering response to metformin (Glucose AUC) in subjects carrying variant OCT1 genotypes (ie. carries at least one of four variant alleles OCT1-R61C, G401S, 420del, and/or OCT1-G465R).
306609|NCT00187681|O2|Outcome|OCT1-reference Group|Metformin blood concentration-time profiles in subjects carrying the reference OCT1 allele at all the four positions in the OCT1 gene.
306610|NCT00187681|O1|Outcome|OCT1-variant Group|Metformin blood concentration-time profiles in subjects carrying the variant OCT1 genotypes (ie. carries at least one of the four variant alleles OCT1-R61C, G401S, 420del, and/or OCT1-G465R).
306611|NCT00187681|E2|Reported Event|OCT1-reference Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
306612|NCT00187681|E1|Reported Event|OCT1-variant Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
306613|NCT00187720|B3|Baseline|Total|Total of all reporting groups
306614|NCT00187720|B2|Baseline|OCT2-variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
306615|NCT00187720|B1|Baseline|OCT2-reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
306616|NCT00187720|P2|Participant Flow|Organic Cation Transporter 2 (OCT2)-Reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
306617|NCT00187720|P1|Participant Flow|Organic Cation Transporter 2 (OCT2)-Variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
306618|NCT00187720|O2|Outcome|OCT2-reference Group|The renal clearance of metformin in subjects homozygous for the reference OCT2 genotype (808G/G) following a single oral dose of 850 mg of metformin.
306619|NCT00187720|O1|Outcome|OCT2-variant Group|The renal clearance of metformin in subjects heterozygous for the variant OCT2 genotype (808G/T, *3D) following a single oral dose of 850 mg of metformin.
306620|NCT00187720|E2|Reported Event|OCT2-variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
306621|NCT00187720|E1|Reported Event|OCT2-reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
306622|NCT00187876|B3|Baseline|Total|Total of all reporting groups
306623|NCT00187876|B2|Baseline|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
306624|NCT00187876|B1|Baseline|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts."
306625|NCT00187876|P2|Participant Flow|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
306626|NCT00187876|P1|Participant Flow|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that are non- irradiated aseptically, processed BTB allografts."
306627|NCT00187876|O2|Outcome|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
307188|NCT00201006|O3|Outcome|Mail Contact|26 biweekly newsletters with weight management advice
306628|NCT00187876|O1|Outcome|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts."
306629|NCT00187876|E2|Reported Event|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
306630|NCT00187876|E1|Reported Event|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using asceptic patellar tendon allografts."
306631|NCT00187889|B3|Baseline|Total|Total of all reporting groups
306632|NCT00187889|B2|Baseline|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
306633|NCT00187889|B1|Baseline|Epleranone|Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks.
306634|NCT00187889|P2|Participant Flow|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
306635|NCT00187889|P1|Participant Flow|Eplerenone|Eplerenone 25 mg (1 pill) daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.
306636|NCT00187889|O2|Outcome|PLACEBO|Inert Placebo
306637|NCT00187889|O1|Outcome|EPLERENONE|Active Drug
306638|NCT00187889|O2|Outcome|PLACEBO|Inert Placebo
306639|NCT00187889|O1|Outcome|EPLERINONE|Active drug
306640|NCT00187889|E2|Reported Event|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
306641|NCT00187889|E1|Reported Event|Epleranone|Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks.
306642|NCT00196716|B1|Baseline|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
307090|NCT00200343|P1|Participant Flow|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
306643|NCT00196716|P1|Participant Flow|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
306644|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
306645|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
306646|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
306647|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
306648|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
306649|NCT00196716|E3|Reported Event|Total|
306650|NCT00196716|E2|Reported Event|0.3 mg/kg Fabrazyme|0.3 mg/kg Fabrazyme, Week 24 to Week 96.
306651|NCT00196716|E1|Reported Event|1.0 mg/kg Fabrazyme|1.0 mg/kg Fabrazyme, Week 0 to Week 24.
306652|NCT00196937|B4|Baseline|Total|Total of all reporting groups
306653|NCT00196937|B3|Baseline|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306654|NCT00196937|B2|Baseline|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306655|NCT00196937|B1|Baseline|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
306656|NCT00196937|P3|Participant Flow|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306657|NCT00196937|P2|Participant Flow|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306658|NCT00196937|P1|Participant Flow|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
306659|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306660|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306661|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
306662|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306663|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306664|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
306665|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306666|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
307189|NCT00201006|O2|Outcome|Telephone Counseling|26 biweekly telephone counseling sessions
306667|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
306668|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306669|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306670|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
306671|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306672|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306673|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
306674|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306675|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306676|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
306677|NCT00196937|O3|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
306678|NCT00196937|O2|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule
306679|NCT00196937|O1|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
306680|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306681|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306682|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
306683|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
306684|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
306685|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine)administered according to a 0, 1, 6-month schedule
306686|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306687|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306688|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
306689|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
306690|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
306691|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine)administered according to a 0, 1, 6-month schedule
306692|NCT00196937|E3|Reported Event|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306693|NCT00196937|E2|Reported Event|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
306694|NCT00196937|E1|Reported Event|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
306695|NCT00196976|B15|Baseline|Total|Total of all reporting groups
306696|NCT00196976|B14|Baseline|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
306697|NCT00196976|B13|Baseline|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
306698|NCT00196976|B12|Baseline|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306699|NCT00196976|B11|Baseline|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306986|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306700|NCT00196976|B10|Baseline|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306701|NCT00196976|B9|Baseline|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306702|NCT00196976|B8|Baseline|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306703|NCT00196976|B7|Baseline|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306704|NCT00196976|B6|Baseline|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306705|NCT00196976|B5|Baseline|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306706|NCT00196976|B4|Baseline|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
328516|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
306707|NCT00196976|B3|Baseline|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306708|NCT00196976|B2|Baseline|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306709|NCT00196976|B1|Baseline|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306710|NCT00196976|P14|Participant Flow|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
306711|NCT00196976|P13|Participant Flow|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
306712|NCT00196976|P12|Participant Flow|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306713|NCT00196976|P11|Participant Flow|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306714|NCT00196976|P10|Participant Flow|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306715|NCT00196976|P9|Participant Flow|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306716|NCT00196976|P8|Participant Flow|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306717|NCT00196976|P7|Participant Flow|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306718|NCT00196976|P6|Participant Flow|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306719|NCT00196976|P5|Participant Flow|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306720|NCT00196976|P4|Participant Flow|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306721|NCT00196976|P3|Participant Flow|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306738|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
307091|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
306722|NCT00196976|P2|Participant Flow|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306723|NCT00196976|P1|Participant Flow|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306724|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
306725|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
306726|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306727|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306728|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306729|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306730|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306731|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306987|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
307190|NCT00201006|O1|Outcome|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
306732|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306733|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306734|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306735|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306736|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306737|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306739|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306740|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306741|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306742|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306743|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306744|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306745|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306746|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306747|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306748|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306749|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306750|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306751|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306752|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306771|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
307092|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
306753|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306754|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306755|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306756|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306757|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306758|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306759|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306760|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306761|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
307251|NCT00201409|P2|Participant Flow|Placebo Group|Participants will be randomized to receive placebo.
306762|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306763|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306764|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306765|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306766|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306767|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
306768|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
306769|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306770|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306772|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
306773|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306774|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306775|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
306776|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
306777|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306778|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306779|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
306780|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
306781|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306782|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306783|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
306784|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
306785|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306786|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306787|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
306788|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
306789|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306790|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306791|NCT00196976|O5|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306971|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306792|NCT00196976|O4|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306793|NCT00196976|O3|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306794|NCT00196976|O2|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306795|NCT00196976|O1|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306796|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306797|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306798|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306799|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
307119|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
306800|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306801|NCT00196976|O5|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306802|NCT00196976|O4|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306803|NCT00196976|O3|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306804|NCT00196976|O2|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306805|NCT00196976|O1|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306806|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306807|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306808|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306809|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306810|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306811|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306812|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306813|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306814|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306815|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306988|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306816|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306817|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306818|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306819|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306820|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306821|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306822|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306972|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306823|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306824|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306825|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306826|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306827|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306828|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306829|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
307410|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
306830|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306831|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306832|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306833|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306834|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306835|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306836|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306837|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306853|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306838|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306839|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306840|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306841|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306842|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306843|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306844|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306989|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306845|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306846|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306847|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306848|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306849|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306850|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306851|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306852|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
307082|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
306854|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306855|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306856|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306857|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306858|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306859|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306990|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306860|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306861|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306862|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306863|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306864|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306865|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306866|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306867|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306868|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
307083|NCT00200057|E1|Reported Event|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
306869|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306870|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306871|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306872|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306873|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306874|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306875|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
307555|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
306876|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306877|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306878|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306879|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306880|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306881|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306882|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306883|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306884|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306885|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306886|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306887|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306888|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306889|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306991|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
315855|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
306890|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306891|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306892|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306893|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306894|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306895|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306896|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306897|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306898|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306938|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
307084|NCT00200343|B4|Baseline|Total|Total of all reporting groups
328517|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
306899|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306900|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306901|NCT00196976|E14|Reported Event|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
306902|NCT00196976|E13|Reported Event|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
306903|NCT00196976|E12|Reported Event|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306904|NCT00196976|E11|Reported Event|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
306905|NCT00196976|E10|Reported Event|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
306906|NCT00196976|E9|Reported Event|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306907|NCT00196976|E8|Reported Event|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306908|NCT00196976|E7|Reported Event|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306909|NCT00196976|E6|Reported Event|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
306910|NCT00196976|E5|Reported Event|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306911|NCT00196976|E4|Reported Event|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306912|NCT00196976|E3|Reported Event|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306913|NCT00196976|E2|Reported Event|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306939|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306940|NCT00197002|O1|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
306914|NCT00196976|E1|Reported Event|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
306915|NCT00197002|B4|Baseline|Total|Total of all reporting groups
306916|NCT00197002|B3|Baseline|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
306917|NCT00197002|B2|Baseline|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306918|NCT00197002|B1|Baseline|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306919|NCT00197002|P3|Participant Flow|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
306920|NCT00197002|P2|Participant Flow|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306921|NCT00197002|P1|Participant Flow|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
307191|NCT00201006|E3|Reported Event|Mail|received by mail 26 biweekly newsletters with weight management information
306922|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
306923|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306924|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306925|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
306926|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306927|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306928|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
306929|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306930|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306931|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
306932|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306933|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306934|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
306935|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306936|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306937|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
307085|NCT00200343|B3|Baseline|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
306941|NCT00197002|O1|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
306942|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306943|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306944|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306945|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306946|NCT00197002|O2|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
306947|NCT00197002|O1|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306948|NCT00197002|O2|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
307556|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
306949|NCT00197002|O1|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306950|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306951|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306952|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306953|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306954|NCT00197002|E3|Reported Event|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
306955|NCT00197002|E2|Reported Event|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
306956|NCT00197002|E1|Reported Event|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
306957|NCT00197015|B4|Baseline|Total|Total of all reporting groups
306958|NCT00197015|B3|Baseline|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306959|NCT00197015|B2|Baseline|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306960|NCT00197015|B1|Baseline|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306961|NCT00197015|P3|Participant Flow|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306962|NCT00197015|P2|Participant Flow|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306963|NCT00197015|P1|Participant Flow|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306964|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306965|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306966|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306967|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306968|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306969|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306970|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306973|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306974|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306975|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306976|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306977|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306978|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306979|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306980|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306981|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306982|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306983|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306984|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306985|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306992|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306993|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306994|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306995|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306996|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
306997|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
306998|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
306999|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
307000|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
307001|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
307002|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
307003|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
307004|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
307005|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
307006|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
307007|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
307008|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
307009|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
307010|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
307011|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
328518|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
307012|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
307013|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
307014|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
307015|NCT00197015|E3|Reported Event|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
307016|NCT00197015|E2|Reported Event|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
307017|NCT00197015|E1|Reported Event|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
307018|NCT00197028|B3|Baseline|Total|Total of all reporting groups
307019|NCT00197028|B2|Baseline|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307020|NCT00197028|B1|Baseline|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307021|NCT00197028|P2|Participant Flow|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307022|NCT00197028|P1|Participant Flow|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307023|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307120|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
315856|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
307024|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307025|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307026|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307027|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307028|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307029|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307030|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307031|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307032|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307086|NCT00200343|B2|Baseline|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
307087|NCT00200343|B1|Baseline|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
328519|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
307033|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307034|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307035|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307036|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307037|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307038|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307039|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307057|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307040|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307041|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307042|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307043|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307044|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307045|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307046|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307047|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307048|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307049|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307088|NCT00200343|P3|Participant Flow|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
307089|NCT00200343|P2|Participant Flow|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
307050|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307051|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307052|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307053|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307054|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307055|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307056|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307058|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307059|NCT00197028|E2|Reported Event|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307060|NCT00197028|E1|Reported Event|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
307061|NCT00199381|B1|Baseline|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
307062|NCT00199381|P1|Participant Flow|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
307063|NCT00199381|O1|Outcome|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
307064|NCT00199381|E1|Reported Event|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
307065|NCT00199914|B3|Baseline|Total|Total of all reporting groups
307066|NCT00199914|B2|Baseline|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
307067|NCT00199914|B1|Baseline|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
307068|NCT00199914|P2|Participant Flow|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
307069|NCT00199914|P1|Participant Flow|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
307070|NCT00199914|O2|Outcome|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
307071|NCT00199914|O1|Outcome|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
307072|NCT00199914|E2|Reported Event|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
307073|NCT00199914|E1|Reported Event|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
307074|NCT00200057|B1|Baseline|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
307075|NCT00200057|P1|Participant Flow|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
307076|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
307077|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
307078|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
307079|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
307080|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
307081|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
307093|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
307094|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
307095|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
307096|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
307097|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
307098|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
307099|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
307100|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
307101|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
307102|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
307103|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
307104|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
307105|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
307106|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
307107|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
307108|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
307109|NCT00200343|E3|Reported Event|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
307110|NCT00200343|E2|Reported Event|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
307111|NCT00200343|E1|Reported Event|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
307112|NCT00200356|B3|Baseline|Total|Total of all reporting groups
307113|NCT00200356|B2|Baseline|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307114|NCT00200356|B1|Baseline|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
307115|NCT00200356|P2|Participant Flow|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307116|NCT00200356|P1|Participant Flow|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
307117|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307184|NCT00201006|B1|Baseline|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
307121|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307122|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
307123|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307124|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
307125|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307126|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
307127|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307128|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
307129|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307130|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
307131|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307132|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
307133|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307134|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
307135|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307136|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
307137|NCT00200356|E2|Reported Event|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
307138|NCT00200356|E1|Reported Event|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
307139|NCT00200785|B3|Baseline|Total|Total of all reporting groups
307140|NCT00200785|B2|Baseline|Garlic Powder: No Allicin|garlic powder in boiling water
307141|NCT00200785|B1|Baseline|Garlic Powder: High Allicin|garlic powder in ambient water
307142|NCT00200785|P2|Participant Flow|Garlic Powder: No Allicin|garlic powder in boiling water
307143|NCT00200785|P1|Participant Flow|Garlic Powder: High Allicin|garlic powder in ambient water
307144|NCT00200785|O2|Outcome|Garlic Powder: No Allicin|garlic powder in boiling water
328520|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
307145|NCT00200785|O1|Outcome|Garlic Powder: High Allicin|garlic powder in ambient water
307146|NCT00200785|O2|Outcome|Garlic Powder: No Allicin|garlic powder in boiling water
307147|NCT00200785|O1|Outcome|Garlic Powder: High Allicin|garlic powder in ambient water
307148|NCT00200785|E2|Reported Event|Garlic Powder: No Allicin|garlic powder in boiling water
307149|NCT00200785|E1|Reported Event|Garlic Powder: High Allicin|garlic powder in ambient water
307150|NCT00200967|B3|Baseline|Total|Total of all reporting groups
307151|NCT00200967|B2|Baseline|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307152|NCT00200967|B1|Baseline|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307153|NCT00200967|P2|Participant Flow|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307154|NCT00200967|P1|Participant Flow|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307155|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307156|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307157|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307158|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307159|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307185|NCT00201006|P3|Participant Flow|Mail Contact|26 biweekly newsletters with weight management advice
307160|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307161|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307162|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307163|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307164|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307165|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307166|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307167|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307168|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307169|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307170|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307210|NCT00201123|E3|Reported Event|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
328521|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
307171|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307172|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307173|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307174|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307175|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307176|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307177|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307178|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307179|NCT00200967|E2|Reported Event|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307180|NCT00200967|E1|Reported Event|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
307181|NCT00201006|B4|Baseline|Total|Total of all reporting groups
307182|NCT00201006|B3|Baseline|Mail Contact|26 biweekly newsletters with weight management advice
307183|NCT00201006|B2|Baseline|Telephone Counseling|26 biweekly telephone counseling sessions
307192|NCT00201006|E2|Reported Event|Telephone|received 26 biweekly individual telephone counseling sessions
307193|NCT00201006|E1|Reported Event|Face-to-face|received 26 biweekly office-based, face-to-face group counseling sessions
307194|NCT00201123|B4|Baseline|Total|Total of all reporting groups
307195|NCT00201123|B3|Baseline|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma."
307196|NCT00201123|B2|Baseline|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
307197|NCT00201123|B1|Baseline|DOTS Control Group|"IRPE Anti-Tuberculous Therapy
IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
307198|NCT00201123|P3|Participant Flow|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
307199|NCT00201123|P2|Participant Flow|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
307200|NCT00201123|P1|Participant Flow|DOTS Control Group|"DOTS Control Group
IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
307201|NCT00201123|O3|Outcome|Subcutaneous rlFN-y|
307202|NCT00201123|O2|Outcome|Nebulized rlFN-y|
307203|NCT00201123|O1|Outcome|DOTS|
307204|NCT00201123|O3|Outcome|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma."
307205|NCT00201123|O2|Outcome|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
307206|NCT00201123|O1|Outcome|DOTS Control Group|"IRPE Anti-Tuberculous Therapy
IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
307207|NCT00201123|O3|Outcome|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
307208|NCT00201123|O2|Outcome|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
307209|NCT00201123|O1|Outcome|DOTS Control Group|"IRPE Anti-Tuberculous Therapy
IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
307580|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
307211|NCT00201123|E2|Reported Event|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
307212|NCT00201123|E1|Reported Event|DOTS Control Group|"DOTS Control Group
IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
307213|NCT00201201|B3|Baseline|Total|Total of all reporting groups
307214|NCT00201201|B2|Baseline|Control|"Control:
Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
307215|NCT00201201|B1|Baseline|Education Intervention|"PEP education intervention
Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program."
307216|NCT00201201|P2|Participant Flow|Control|"Control:
Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
307217|NCT00201201|P1|Participant Flow|Education Intervention|"PEP education intervention
Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
307218|NCT00201201|O2|Outcome|Control|"Control:
Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
307219|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention
Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
307220|NCT00201201|O2|Outcome|Control|"Control:
Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
307221|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention
Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
307250|NCT00201409|B1|Baseline|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
307222|NCT00201201|O2|Outcome|Control|"Control:
Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
307223|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention
Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
307224|NCT00201201|O2|Outcome|Control|"Control:
Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
307225|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention
Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
307226|NCT00201201|O2|Outcome|Control|"Control:
Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
307227|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention
Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
307581|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307228|NCT00201201|O2|Outcome|Control|"Control:
Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
307229|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention
Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
307230|NCT00201201|E2|Reported Event|Control|Control group without education intervention.
307231|NCT00201201|E1|Reported Event|Education|"PEP education intervention
Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension will be randomized to usual care and intervention groups. Both groups will enter medication taking behaviors on the PEP-NG and answer questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The intervention group will receive a tailored education program."
307232|NCT00201240|B1|Baseline|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307233|NCT00201240|P1|Participant Flow|T Cell Depletion|T cell depletion using Miltenyi device for patients with acute myeloid leukemia (AML) in first or second complete remission
307234|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307235|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with acute myeloid leukemia (AML) in first or second complete remission
307236|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307237|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307238|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307239|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307240|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307241|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307242|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307243|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307244|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307245|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307246|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307247|NCT00201240|E1|Reported Event|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
307248|NCT00201409|B3|Baseline|Total|Total of all reporting groups
307249|NCT00201409|B2|Baseline|Placebo Group|Participants will be randomized to receive placebo.
307252|NCT00201409|P1|Participant Flow|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
307253|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
307254|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
307255|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
307256|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
307257|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
307258|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
307259|NCT00201409|E2|Reported Event|Placebo Group|Participants will be randomized to receive placebo.
307260|NCT00201409|E1|Reported Event|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
307261|NCT00185211|B3|Baseline|Total|Total of all reporting groups
307262|NCT00185211|B2|Baseline|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307263|NCT00185211|B1|Baseline|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307264|NCT00185211|P2|Participant Flow|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307265|NCT00185211|P1|Participant Flow|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307266|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307267|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307268|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307269|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307270|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307271|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307272|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307273|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307274|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307275|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307276|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307277|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307278|NCT00185211|O1|Outcome|All Subjects|All subjects part of Intention-To-Treat (ITT) Population
307279|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307280|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307281|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307282|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307283|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307284|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307285|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307286|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307287|NCT00185211|E2|Reported Event|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
307288|NCT00185211|E1|Reported Event|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
307289|NCT00191724|B6|Baseline|Total|Total of all reporting groups
307290|NCT00191724|B5|Baseline|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307291|NCT00191724|B4|Baseline|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307292|NCT00191724|B3|Baseline|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307293|NCT00191724|B2|Baseline|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307294|NCT00191724|B1|Baseline|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307295|NCT00191724|P5|Participant Flow|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307296|NCT00191724|P4|Participant Flow|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307297|NCT00191724|P3|Participant Flow|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307298|NCT00191724|P2|Participant Flow|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307299|NCT00191724|P1|Participant Flow|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307582|NCT00192296|E4|Reported Event|MEDI-528 9 mg|
307583|NCT00192296|E3|Reported Event|MEDI-528 3 mg|
307300|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307301|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307302|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307303|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307304|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307305|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307306|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307307|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307308|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307309|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307310|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307311|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307312|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307313|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307314|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307315|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
315857|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
307316|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307317|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307318|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307319|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307320|NCT00191724|E5|Reported Event|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307321|NCT00191724|E4|Reported Event|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307322|NCT00191724|E3|Reported Event|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307323|NCT00191724|E2|Reported Event|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307324|NCT00191724|E1|Reported Event|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
307377|NCT00191906|B2|Baseline|Placebo First, Then Atomoxetine|Placebo for 4 weeks, 2 week washout, and then atomoxetine 1.2 mg/kg/day for 4 weeks.
307325|NCT00191789|B1|Baseline|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307326|NCT00191789|P1|Participant Flow|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307327|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307328|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307329|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307330|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307331|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307332|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307333|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307362|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
307557|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307334|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307335|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307336|NCT00191789|E1|Reported Event|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
307337|NCT00191815|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307338|NCT00191815|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307339|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307340|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307341|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307342|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307343|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307344|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307345|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307346|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307347|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307348|NCT00191815|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
307349|NCT00191854|B4|Baseline|Total|Total of all reporting groups
307350|NCT00191854|B3|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
307351|NCT00191854|B2|Baseline|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
307352|NCT00191854|B1|Baseline|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
307353|NCT00191854|P3|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
307354|NCT00191854|P2|Participant Flow|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
307355|NCT00191854|P1|Participant Flow|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
307356|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
307357|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
307358|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
307359|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
307360|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
307361|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
307408|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
307409|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
307363|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
307364|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
307365|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
307366|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
307367|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
307368|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
307369|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
307370|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
307371|NCT00191854|E3|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
307372|NCT00191854|E2|Reported Event|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
307373|NCT00191854|E1|Reported Event|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
307374|NCT00191906|B5|Baseline|Total|Total of all reporting groups
307375|NCT00191906|B4|Baseline|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
307376|NCT00191906|B3|Baseline|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
307584|NCT00192296|E2|Reported Event|MEDI-528 1 mg|
307378|NCT00191906|B1|Baseline|Atomoxetine First, Then Placebo|Atomoxetine 1.2 mg/kg/day for 4 weeks, 2 week washout, and then placebo for 4 weeks
307379|NCT00191906|P4|Participant Flow|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
307380|NCT00191906|P3|Participant Flow|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
307381|NCT00191906|P2|Participant Flow|Placebo First, Then Atomoxetine|Placebo every day, by mouth for 4 weeks, 2 week washout period and then cross-over to atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks.
307382|NCT00191906|P1|Participant Flow|Atomoxetine First, Then Placebo|Atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks, 2 week washout period and then cross-over to placebo, every day, by mouth for 4 weeks.
307383|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
307384|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
307385|NCT00191906|O1|Outcome|ADHD-C+RD|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
307386|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
307387|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
307388|NCT00191906|O1|Outcome|ADHD-C+ RD|atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
307389|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
307390|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
307391|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
307392|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
307393|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
307394|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
307395|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
307396|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
307397|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
307398|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
307399|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
307400|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
307401|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
307402|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
307403|NCT00191906|O2|Outcome|Placebo|
307404|NCT00191906|O1|Outcome|Atomoxetine|
307405|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
307406|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
307407|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
307411|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
307412|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
307413|NCT00191906|O1|Outcome|ADHD-C+RD|atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
307414|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
307415|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
307416|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
307417|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
307418|NCT00191906|E3|Reported Event|Open Label Atomoxetine|Patients in the Open Label extension receiving Atomoxetine
307419|NCT00191906|E2|Reported Event|As Randomized Atomoxetine (Crossover)|Patients in either Crossover Period receiving Atomoxetine
307420|NCT00191906|E1|Reported Event|As Randomized Placebo (Crossover)|Patients in either Crossover Period receiving Placebo
307421|NCT00191945|B3|Baseline|Total|Total of all reporting groups
307422|NCT00191945|B2|Baseline|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307423|NCT00191945|B1|Baseline|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307424|NCT00191945|P2|Participant Flow|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307425|NCT00191945|P1|Participant Flow|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307585|NCT00192296|E1|Reported Event|MEDI-528 0.3 mg|
307586|NCT00192647|B3|Baseline|Total|Total of all reporting groups
307426|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307427|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307428|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307429|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307430|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307431|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307432|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307433|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307434|NCT00191945|O1|Outcome|Atomoxetine|0.5 mg/kg/day QD, PO for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year
307435|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307436|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307437|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307438|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307439|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307440|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307441|NCT00191945|O1|Outcome|Atomoxetine|0.5 mg/kg/day QD, PO for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year
307442|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307443|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307444|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307445|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307446|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307447|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307448|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307449|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307450|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307451|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307452|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307453|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307517|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
307454|NCT00191945|E2|Reported Event|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307455|NCT00191945|E1|Reported Event|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
307456|NCT00191984|B1|Baseline|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
307457|NCT00191984|P1|Participant Flow|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
307458|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
307459|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
307460|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
307461|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
307462|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
307463|NCT00191984|E1|Reported Event|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
307464|NCT00192023|B3|Baseline|Total|Total of all reporting groups
307465|NCT00192023|B2|Baseline|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307466|NCT00192023|B1|Baseline|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307467|NCT00192023|P2|Participant Flow|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307468|NCT00192023|P1|Participant Flow|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307469|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307470|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307471|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307472|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307473|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307474|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307475|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307476|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307477|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307478|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307479|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307480|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307481|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307482|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307483|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307518|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
307484|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307485|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307486|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307487|NCT00192023|E2|Reported Event|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307488|NCT00192023|E1|Reported Event|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
307489|NCT00192036|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
307490|NCT00192036|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
307491|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
307492|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
307493|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
307494|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
307495|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
307496|NCT00192036|E1|Reported Event|Gemcitabine + Cisplatin|Gemcitabine: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5) Cisplatin: 80 mg/m2, IV, q 21 days x 5 cycles Radiation: 63 Gy in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
307497|NCT00192075|B3|Baseline|Total|Total of all reporting groups
307498|NCT00192075|B2|Baseline|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
307499|NCT00192075|B1|Baseline|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
307558|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307500|NCT00192075|P2|Participant Flow|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
307501|NCT00192075|P1|Participant Flow|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
307502|NCT00192075|O1|Outcome|A + FOLFOX 4 - Avastin Subgroup|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
307503|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
307504|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
307505|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
307506|NCT00192075|O1|Outcome|A+FFG - Avastin Subgrouup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
307507|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
307508|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
307509|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
307510|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
307511|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Includes patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
307512|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
307513|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
307514|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
307515|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
307516|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
307579|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
307519|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
307520|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
307521|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
307522|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
307523|NCT00192075|E2|Reported Event|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
307524|NCT00192075|E1|Reported Event|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
307525|NCT00192296|B5|Baseline|Total|Total of all reporting groups
307526|NCT00192296|B4|Baseline|MEDI-528 9 mg|
307527|NCT00192296|B3|Baseline|MEDI-528 3 mg|
307528|NCT00192296|B2|Baseline|MEDI-528 1 mg|
307529|NCT00192296|B1|Baseline|MEDI-528 0.3 mg|
307530|NCT00192296|P4|Participant Flow|MEDI-528 9 mg|
307531|NCT00192296|P3|Participant Flow|MEDI-528 3 mg|
307532|NCT00192296|P2|Participant Flow|MEDI-528 1 mg|
307533|NCT00192296|P1|Participant Flow|MEDI-528 0.3 mg|
307534|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307535|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
307536|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
307537|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307538|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307539|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
307540|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
307541|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307542|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307543|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
307544|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
307545|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307546|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307547|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
307548|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
307549|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307550|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307551|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
307552|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
307553|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307554|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307559|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
307560|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
307561|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307562|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307563|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
307564|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
307565|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307566|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307567|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
307568|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
307569|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307570|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307571|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
307572|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
307573|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307574|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307575|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
307576|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
307577|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
307578|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
307587|NCT00192647|B2|Baseline|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
307588|NCT00192647|B1|Baseline|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
307589|NCT00192647|P2|Participant Flow|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
307590|NCT00192647|P1|Participant Flow|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with peginterferon (PEG-IFN) alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
307591|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
307592|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
307593|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
307594|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
307595|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
307596|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
307597|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
307598|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
307599|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
307900|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
307600|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
307601|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
307602|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
307603|NCT00192647|E2|Reported Event|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
307604|NCT00192647|E1|Reported Event|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
307605|NCT00193037|B3|Baseline|Total|Total of all reporting groups
307606|NCT00193037|B2|Baseline|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.
Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
307722|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307607|NCT00193037|B1|Baseline|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)
Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.
Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
307608|NCT00193037|P2|Participant Flow|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.
Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria."
307609|NCT00193037|P1|Participant Flow|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)
Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.
Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided patient still met the eligibility laboratory and performance status criteria."
307610|NCT00193037|O2|Outcome|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.
Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
307611|NCT00193037|O1|Outcome|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)
Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.
Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
307612|NCT00193037|O2|Outcome|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.
Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
307613|NCT00193037|O1|Outcome|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)
Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.
Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
307614|NCT00193037|E2|Reported Event|Arm B - Docetaxel Then Liposomal Doxorubicin|Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8, and 15 followed by one week rest, administered on an every 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria.
307615|NCT00193037|E1|Reported Event|Arm A - Liposomal Doxorubicin Then Docetaxel|Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q28 days thru peripheral vein or central venous access. This will define one cycle. Patients demonstrating progression on Liposomal Doxorubicin were eligible for crossover to treatment on Docetaxel, provided patient still met the eligibility lab and performance status criteria.
307616|NCT00193050|B1|Baseline|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
307901|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
307617|NCT00193050|P1|Participant Flow|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
307618|NCT00193050|O1|Outcome|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
307619|NCT00193050|E1|Reported Event|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
307620|NCT00193063|B1|Baseline|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
307621|NCT00193063|P1|Participant Flow|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
307774|NCT00194129|B3|Baseline|Total|Total of all reporting groups
307622|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
307623|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
307624|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
307625|NCT00193063|E1|Reported Event|Intervention|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
307626|NCT00193128|B3|Baseline|Total|Total of all reporting groups
307627|NCT00193128|B2|Baseline|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.
Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
307628|NCT00193128|B1|Baseline|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
307629|NCT00193128|P2|Participant Flow|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.
Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
307630|NCT00193128|P1|Participant Flow|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
307631|NCT00193128|O2|Outcome|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.
Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
307632|NCT00193128|O1|Outcome|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
307633|NCT00193128|E2|Reported Event|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.
Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
307634|NCT00193128|E1|Reported Event|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
307635|NCT00193180|B1|Baseline|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
307636|NCT00193180|P1|Participant Flow|Intervention|All patients in this study received docetaxel 30 mg/m^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
307637|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
307638|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
307639|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
307640|NCT00193180|E1|Reported Event|Docetaxel+Imatinib|Patients received docetaxel 30mg/m2 IV weekly on days 1, 8, and 15 of each 28 day cycle. Patients received oral imatinib 400mg daily. Fifteen patients initially received oral imatinib 600mg daily but had their dose reduced to 400mg daily when they were unable to tolerate the higher dose.
307641|NCT00193206|B1|Baseline|Intervention|"Systemic Therapy
ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
307642|NCT00193206|P1|Participant Flow|Intervention|"Systemic Therapy
ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
307643|NCT00193206|O1|Outcome|Intervention|"Systemic Therapy
ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
307644|NCT00193206|E1|Reported Event|Intervention|"Systemic Therapy
ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
307645|NCT00193219|B1|Baseline|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
307646|NCT00193219|P1|Participant Flow|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
307647|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
307648|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
307667|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
307649|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
307650|NCT00193219|E1|Reported Event|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
307651|NCT00193258|B1|Baseline|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
307652|NCT00193258|P1|Participant Flow|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
307653|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
307654|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
307655|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
307775|NCT00194129|B2|Baseline|Lithium Plus Placebo|
307776|NCT00194129|B1|Baseline|Lithium Plus Divalproex|
307656|NCT00193258|E1|Reported Event|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
307657|NCT00193375|B1|Baseline|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
307658|NCT00193375|P1|Participant Flow|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
307659|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
307660|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
307661|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
307662|NCT00193375|E1|Reported Event|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
307663|NCT00193414|B1|Baseline|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
307664|NCT00193414|P1|Participant Flow|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
307665|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
307666|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
308560|NCT00209417|B2|Baseline|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL
Iopamidol 300-Arm 2"
307668|NCT00193414|E1|Reported Event|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
307669|NCT00193427|B1|Baseline|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
307670|NCT00193427|P1|Participant Flow|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
307671|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
307672|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
307673|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered.
307777|NCT00194129|P2|Participant Flow|Lithium Plus Placebo|
307778|NCT00194129|P1|Participant Flow|Lithium Plus Divalproex|
307674|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
307675|NCT00193427|E1|Reported Event|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
307676|NCT00193453|B1|Baseline|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
307677|NCT00193453|P1|Participant Flow|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
307678|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
307679|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
307680|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
307681|NCT00193453|E1|Reported Event|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
307682|NCT00193479|B1|Baseline|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
307683|NCT00193479|P1|Participant Flow|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
307684|NCT00193479|O1|Outcome|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
307685|NCT00193479|E1|Reported Event|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
307686|NCT00193492|B3|Baseline|Total|Total of all reporting groups
307708|NCT00193609|B1|Baseline|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
315858|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
307687|NCT00193492|B2|Baseline|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.
Bevacizumab
Rituximab"
307688|NCT00193492|B1|Baseline|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.
Rituximab"
307689|NCT00193492|P2|Participant Flow|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.
Bevacizumab
Rituximab"
307690|NCT00193492|P1|Participant Flow|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.
Rituximab"
307691|NCT00193492|O2|Outcome|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.
Bevacizumab
Rituximab"
307692|NCT00193492|O1|Outcome|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.
Rituximab"
307721|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307779|NCT00194129|O2|Outcome|Lithium Plus Placebo|
307693|NCT00193492|O2|Outcome|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.
Bevacizumab
Rituximab"
307694|NCT00193492|O1|Outcome|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.
Rituximab"
307695|NCT00193492|E2|Reported Event|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.
Bevacizumab
Rituximab"
307696|NCT00193492|E1|Reported Event|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.
Rituximab"
307697|NCT00193596|B3|Baseline|Total|Total of all reporting groups
307698|NCT00193596|B2|Baseline|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval"
307699|NCT00193596|B1|Baseline|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval"
307700|NCT00193596|P2|Participant Flow|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval"
307701|NCT00193596|P1|Participant Flow|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval"
307702|NCT00193596|O2|Outcome|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval"
307703|NCT00193596|O1|Outcome|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval"
307704|NCT00193596|O2|Outcome|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval"
307705|NCT00193596|O1|Outcome|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval"
307706|NCT00193596|E2|Reported Event|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval"
307707|NCT00193596|E1|Reported Event|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval"
307709|NCT00193609|P1|Participant Flow|Oxaliplatin/Capecitabine|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
307710|NCT00193609|O1|Outcome|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
307711|NCT00193609|O1|Outcome|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
307712|NCT00193609|E1|Reported Event|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
307713|NCT00194012|B3|Baseline|Total|Total of all reporting groups
307714|NCT00194012|B2|Baseline|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307715|NCT00194012|B1|Baseline|Abilify Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307716|NCT00194012|P2|Participant Flow|Placebo|placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307717|NCT00194012|P1|Participant Flow|Aripiprazole|Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307718|NCT00194012|O2|Outcome|Open-Label Extension (Placebo)|"Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.
All participants in the open-label extension were taking Abilify (aripiprazole)."
307719|NCT00194012|O1|Outcome|Open-Label Extension (Abilify)|"Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.
All participants in the open-label extension were taking Abilify (aripiprazole)."
307720|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307723|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307724|NCT00194012|O2|Outcome|Open-Label Extension (Placebo)|"Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.
All participants in the open-label extension were taking Abilify (aripiprazole)."
307725|NCT00194012|O1|Outcome|Open-Label Extension (Abilify)|"Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.
All participants in the open-label extension were taking Abilify (aripiprazole)."
307726|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307727|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307728|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307729|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307730|NCT00194012|O2|Outcome|Open-Label Extension (Placebo)|"Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.
All participants in the open-label extension were taking Abilify (aripiprazole)."
307731|NCT00194012|O1|Outcome|Open-Label Extension (Abilify)|"Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.
All participants in the open-label extension were taking Abilify (aripiprazole)."
307732|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307733|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307734|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307735|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307736|NCT00194012|O2|Outcome|Open-Label Extension (Placebo)|"Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.
All participants in the open-label extension were taking Abilify (aripiprazole)."
307737|NCT00194012|O1|Outcome|Open-Label Extension (Abilify)|"Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.
All participants in the open-label extension were taking Abilify (aripiprazole)."
307738|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307739|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307740|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307898|NCT00203047|P1|Participant Flow|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
307741|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307742|NCT00194012|O2|Outcome|Open-Label Extension (Placebo)|"Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.
All participants in the open-label extension were taking Abilify (aripiprazole)."
307743|NCT00194012|O1|Outcome|Open-Label Extension (Abilify)|"Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.
All participants in the open-label extension were taking Abilify (aripiprazole)."
307744|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307745|NCT00194012|O1|Outcome|Abilify Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307746|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307747|NCT00194012|O1|Outcome|Abilify Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307748|NCT00194012|E4|Reported Event|Open Label Extension (Placebo)|Previously randomized to placebo group.
307749|NCT00194012|E3|Reported Event|Open Label Extension (Abilify)|Previously randomized to Abilify group.
307750|NCT00194012|E2|Reported Event|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
307751|NCT00194012|E1|Reported Event|Abilify Randomized Phase|Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
307752|NCT00194025|B1|Baseline|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307753|NCT00194025|P1|Participant Flow|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307754|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307755|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307756|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307757|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307758|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307759|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307760|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307899|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
307761|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307762|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307763|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307764|NCT00194025|E1|Reported Event|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
307765|NCT00194077|B3|Baseline|Total|Total of all reporting groups
307766|NCT00194077|B2|Baseline|Placebo|Placebo (Children with Symptoms of Mania Study)
307767|NCT00194077|B1|Baseline|Aripiprazole|Abilify (Children with Symptoms of Mania Study)
307768|NCT00194077|P2|Participant Flow|Placebo|Randomized assignment to placebo
307769|NCT00194077|P1|Participant Flow|Aripiprazole|Random assignment with titrated dosing
307770|NCT00194077|O2|Outcome|Placebo|Placebo dosing to mirror active treatment
307771|NCT00194077|O1|Outcome|Aripiprazole|Aripiprazole dosing dependent upon response
307772|NCT00194077|E2|Reported Event|Placebo|Placebo (Children With Symptoms of Mania Study)
307773|NCT00194077|E1|Reported Event|Aripiprazole|Abilify (Children With Symptoms of Mania Study)
307788|NCT00201448|O2|Outcome|Towne Vaccine|"Towne vaccine given at 3000 pfu/subject
Towne CMV Vaccine: Single dose given subcutaneously"
307789|NCT00201448|O1|Outcome|Placebo (Hepatitis A)|"Placebo group
Hepatitis A Vaccine: Single dose give IM"
307790|NCT00201448|O2|Outcome|Towne CMV Vaccine|
307791|NCT00201448|O1|Outcome|(Placebo) Hepatitis a|This is the comparator group.
307792|NCT00201448|E2|Reported Event|Towne CMV Vaccine|
307793|NCT00201448|E1|Reported Event|Placebo (Hepatitis A)|
307794|NCT00201643|B3|Baseline|Total|Total of all reporting groups
307795|NCT00201643|B2|Baseline|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307796|NCT00201643|B1|Baseline|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
307797|NCT00201643|P2|Participant Flow|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307798|NCT00201643|P1|Participant Flow|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
307799|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307800|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
307801|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307802|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
307803|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307804|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
315859|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
307805|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307806|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
307807|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307808|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
307809|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307810|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
307811|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307812|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
307872|NCT00202839|P1|Participant Flow|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
328522|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
307813|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307814|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
307815|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307816|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
307817|NCT00201643|E2|Reported Event|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
307818|NCT00201643|E1|Reported Event|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
307819|NCT00201734|B3|Baseline|Total|Total of all reporting groups
307820|NCT00201734|B2|Baseline|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
307821|NCT00201734|B1|Baseline|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
307822|NCT00201734|P2|Participant Flow|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
307823|NCT00201734|P1|Participant Flow|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
307824|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
307825|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
307826|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
307827|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
307828|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
307829|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
307830|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
307831|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
307832|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
307833|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
307834|NCT00201734|O1|Outcome|Phase I Patients|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
307835|NCT00201734|E2|Reported Event|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
307836|NCT00201734|E1|Reported Event|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
307837|NCT00201773|B1|Baseline|Exemestane & Celecoxib|"Patients will received exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.
Exemestane: 25 mg orally once per day for 16 weeks.
Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day and instructed to take the drug with food.
Correlative studies"
307873|NCT00202839|O2|Outcome|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
308016|NCT00203476|E3|Reported Event|Ezetimibe|Ezetimibe added to max tolerated dose statin
307838|NCT00201773|P1|Participant Flow|Exemestane & Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.
Exemestane: 25 mg orally once per day for 16 weeks.
Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.
Correlative studies"
307839|NCT00201773|O1|Outcome|Exemestane & Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.
Exemestane: 25 mg orally once per day for 16 weeks.
Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.
Correlative studies"
307840|NCT00201773|O2|Outcome|Exemestane|Exemestane (8 weeks) vs. Baseline
307841|NCT00201773|O1|Outcome|Exemestane + Celecoxib|Exemestane + celecoxib (16 weeks) vs. Baseline
307842|NCT00201773|E2|Reported Event|Exemestane + Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.
Exemestane: 25 mg orally once per day for 16 weeks.
Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food."
307843|NCT00201773|E1|Reported Event|Exemestane Alone|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.
Exemestane: 25 mg orally once per day for 16 weeks.
Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food."
307844|NCT00202449|B4|Baseline|Total|Total of all reporting groups
307845|NCT00202449|B3|Baseline|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
307846|NCT00202449|B2|Baseline|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
307847|NCT00202449|B1|Baseline|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
307848|NCT00202449|P3|Participant Flow|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
307849|NCT00202449|P2|Participant Flow|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
307850|NCT00202449|P1|Participant Flow|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
307851|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
307852|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
307853|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
307854|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
307855|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
307856|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
307857|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
307858|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
307859|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
307860|NCT00202449|E3|Reported Event|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
307861|NCT00202449|E2|Reported Event|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
307862|NCT00202449|E1|Reported Event|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
307863|NCT00202722|B1|Baseline|Women in Labour Given Remifentanil Analgesia|Administration of remifentanil analgesia startet with cervical dilatation > 4 cm
307864|NCT00202722|P1|Participant Flow|Effect and Side Effects of Remifentanil|Analgesic efficacy and side offects of remifentanil during labour and delivery
307865|NCT00202722|O1|Outcome|Satisfaction With Remifentanil Analgesia|Patient satisfaction with remifentanil pain relief by use of questionnaire (within 24-hours after delivery)
307866|NCT00202722|O1|Outcome|Remifentanil|"Pain scores
Satisfaction"
307867|NCT00202722|E1|Reported Event|Maternal Oxygen Desaturation|Oxygen saturation lower than 92% during labour and delivery
307868|NCT00202839|B3|Baseline|Total|Total of all reporting groups
307869|NCT00202839|B2|Baseline|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
307870|NCT00202839|B1|Baseline|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
307871|NCT00202839|P2|Participant Flow|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
308015|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
307874|NCT00202839|O1|Outcome|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
307875|NCT00202839|O2|Outcome|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
307876|NCT00202839|O1|Outcome|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
307877|NCT00202839|E2|Reported Event|48-Week Treatment|
307878|NCT00202839|E1|Reported Event|24-Week Treatment|
307879|NCT00202878|B3|Baseline|Total|Total of all reporting groups
307880|NCT00202878|B2|Baseline|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
307881|NCT00202878|B1|Baseline|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
307882|NCT00202878|P2|Participant Flow|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
307883|NCT00202878|P1|Participant Flow|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
307884|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
307885|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
307886|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
307887|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
307888|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
307889|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
307890|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
307891|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
307892|NCT00202878|E2|Reported Event|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
307893|NCT00202878|E1|Reported Event|Ezetimide/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
307894|NCT00203047|B3|Baseline|Total|Total of all reporting groups
307895|NCT00203047|B2|Baseline|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
307896|NCT00203047|B1|Baseline|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
307897|NCT00203047|P2|Participant Flow|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
315860|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
307902|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
307903|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
307904|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
307905|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
307906|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
307907|NCT00203047|E2|Reported Event|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
307908|NCT00203047|E1|Reported Event|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
307909|NCT00203203|B3|Baseline|Total|Total of all reporting groups
307910|NCT00203203|B2|Baseline|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307911|NCT00203203|B1|Baseline|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307912|NCT00203203|P2|Participant Flow|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307913|NCT00203203|P1|Participant Flow|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307914|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307915|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307916|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307917|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307918|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307919|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307920|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307921|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307922|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307923|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307924|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307925|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307926|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307927|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307928|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307929|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307930|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307931|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307932|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307933|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307934|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307935|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307936|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307937|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307938|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
307939|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307940|NCT00203203|E2|Reported Event|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
308561|NCT00209417|B1|Baseline|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL
Iodixanol 320-Arm 1"
307941|NCT00203203|E1|Reported Event|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy."
307942|NCT00203216|B1|Baseline|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
307943|NCT00203216|P1|Participant Flow|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
307944|NCT00203216|O1|Outcome|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
307945|NCT00203216|E1|Reported Event|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
307946|NCT00203229|B3|Baseline|Total|Total of all reporting groups
307947|NCT00203229|B2|Baseline|Lamotrigine|The intervention type is 'drug' and this arm is the active drug created and supplied by the manufacturers of lamotrigine (Lamictal). This is an anti-seizure medication.
307948|NCT00203229|B1|Baseline|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
307949|NCT00203229|P2|Participant Flow|Lamotrigine|The intervention type is 'drug' and this arm is the active drug supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. This drug is an anti-seizure medication.
307950|NCT00203229|P1|Participant Flow|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
307951|NCT00203229|O2|Outcome|Lamotrigine|Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
307952|NCT00203229|O1|Outcome|Placebo|Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
307953|NCT00203229|E2|Reported Event|Lamotrigine|Subjects who received Lamotrigine
307954|NCT00203229|E1|Reported Event|Placebo|Subjects who received placebo
307955|NCT00203242|B1|Baseline|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
307956|NCT00203242|P1|Participant Flow|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
307957|NCT00203242|O1|Outcome|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
307958|NCT00203242|E1|Reported Event|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
307959|NCT00203268|B1|Baseline|Treatment Group|Subjects who treated a moderate to severe migraine 2 hours and 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
307960|NCT00203268|P1|Participant Flow|Treatment Group|Subjects who treated a moderate to severe migraine at 1 hour and at 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. intramuscular (IM). Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
307961|NCT00203268|O2|Outcome|Late Treatment|Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
307962|NCT00203268|O1|Outcome|Early Treatment|Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
307963|NCT00203268|E2|Reported Event|Late Treatment|Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
307964|NCT00203268|E1|Reported Event|Early Treatment|Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
307965|NCT00203294|B3|Baseline|Total|Total of all reporting groups
308609|NCT00211172|B3|Baseline|Total|Total of all reporting groups
307966|NCT00203294|B2|Baseline|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
307967|NCT00203294|B1|Baseline|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
307968|NCT00203294|P2|Participant Flow|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
307969|NCT00203294|P1|Participant Flow|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
307970|NCT00203294|O2|Outcome|Lidocaine 2% and Bupivacaine 0.25% Plus Triamcinolone 40 mg.|Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections
307971|NCT00203294|O1|Outcome|Lidocaine 2% and Bupivacaine 0.25% Plus Saline|Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections
307972|NCT00203294|E2|Reported Event|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
307973|NCT00203294|E1|Reported Event|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
307974|NCT00203307|B3|Baseline|Total|Total of all reporting groups
307975|NCT00203307|B2|Baseline|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
307976|NCT00203307|B1|Baseline|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
307977|NCT00203307|P2|Participant Flow|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
307978|NCT00203307|P1|Participant Flow|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
307979|NCT00203307|O2|Outcome|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
307980|NCT00203307|O1|Outcome|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
307981|NCT00203307|E2|Reported Event|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
307982|NCT00203307|E1|Reported Event|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
307983|NCT00203411|B1|Baseline|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
307984|NCT00203411|P1|Participant Flow|Bevacizumab Plus Capecitabine|"Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Capecitabine (Xeloda): 1000mg/m2 administered orally twice daily for two weeks followed by one week rest period
Bevacizumab: 7.5 mg/kg IV will be administered every 3 weeks"
307985|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
307986|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
307987|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
307988|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
307989|NCT00203411|E1|Reported Event|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
307990|NCT00203424|B1|Baseline|Erlotinib + Bevacizumab|Participants that entered treatment period.
308031|NCT00203892|P3|Participant Flow|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308057|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
308712|NCT00211510|B3|Baseline|Total|Total of all reporting groups
307991|NCT00203424|P1|Participant Flow|Erlotinib + Bevacizumab|27 participants were screened for the study. 4 did not meet eligibility criteria,23 were registered to treatment period. 1 withdrew consent a day after registration and did not initiate study treatment.22 participants entered treatment period. Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses. The protocol instructed that pts be treated for 6 cycles. Of the 22 pts that started treatment, 11 completed the 6 cycles and the other 11 had to stop treatment prior to administration of 6th cycle. Of the 11 pts that did not complete all 6 cycles, 5 stopped treatment due to adverse event and were entered into the follow-up period. The 6 that stopped treatment due to withdrawal of consent and progressive disease did not enter the follow-up period. So 11 pts that completed 6 cycles of treatment plus 5 pts that did not complete 6 cycles of treatment due to an adverse event gives a total of 16 patients who entered follow-up period.
307992|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
307993|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
307994|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
307995|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
307996|NCT00203424|E1|Reported Event|Erlotinib + Bevacizumab|Participants that entered treatment period.
307997|NCT00203476|B4|Baseline|Total|Total of all reporting groups
307998|NCT00203476|B3|Baseline|Ezetimibe|Ezetimibe added to max tolerated dose statin
307999|NCT00203476|B2|Baseline|Colestipol|Colestipol added to max dose statin
308000|NCT00203476|B1|Baseline|Niacin|Niacin added to max tolerated dose of statin
308001|NCT00203476|P3|Participant Flow|Ezetimibe|Ezetimibe added to max tolerated dose statin
308002|NCT00203476|P2|Participant Flow|Colestipol|Colestipol added to max dose statin
308003|NCT00203476|P1|Participant Flow|Niacin|Niacin added to max tolerated dose of statin
308004|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
308005|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
308006|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
308007|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
308008|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
308009|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
308010|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
308011|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
308012|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
308013|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
308014|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
328523|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
308017|NCT00203476|E2|Reported Event|Colestipol|Colestipol added to max dose statin
308018|NCT00203476|E1|Reported Event|Niacin|Niacin added to max tolerated dose of statin
308019|NCT00203502|B1|Baseline|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2
+ Avastin 15 mg/kg
Q 3 weeks X 4 cycles
Bevacizumab/Avastin: IV 15mg/kg 21 days
Cyclophosphamide: 500mg per meter squared, IV every 21 days
Doxorubicin: 60 mg per meter squared, IV every 21 days"
308020|NCT00203502|P1|Participant Flow|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2
+ Avastin 15 mg/kg
Q 3 weeks X 4 cycles
Bevacizumab/Avastin: IV 15mg/kg 21 days
Cyclophosphamide: 500mg per meter squared, IV every 21 days
Doxorubicin: 60 mg per meter squared, IV every 21 days"
308021|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2
+ Avastin 15 mg/kg
Q 3 weeks X 4 cycles
Bevacizumab/Avastin: IV 15mg/kg 21 days
Cyclophosphamide: 500mg per meter squared, IV every 21 days
Doxorubicin: 60 mg per meter squared, IV every 21 days"
308022|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2
+ Avastin 15 mg/kg
Q 3 weeks X 4 cycles
Bevacizumab/Avastin: IV 15mg/kg 21 days
Cyclophosphamide: 500mg per meter squared, IV every 21 days
Doxorubicin: 60 mg per meter squared, IV every 21 days"
308023|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2
+ Avastin 15 mg/kg
Q 3 weeks X 4 cycles
Bevacizumab/Avastin: IV 15mg/kg 21 days
Cyclophosphamide: 500mg per meter squared, IV every 21 days
Doxorubicin: 60 mg per meter squared, IV every 21 days"
308024|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2
+ Avastin 15 mg/kg
Q 3 weeks X 4 cycles
Bevacizumab/Avastin: IV 15mg/kg 21 days
Cyclophosphamide: 500mg per meter squared, IV every 21 days
Doxorubicin: 60 mg per meter squared, IV every 21 days"
308025|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2
+ Avastin 15 mg/kg
Q 3 weeks X 4 cycles
Bevacizumab/Avastin: IV 15mg/kg 21 days
Cyclophosphamide: 500mg per meter squared, IV every 21 days
Doxorubicin: 60 mg per meter squared, IV every 21 days"
308026|NCT00203502|E1|Reported Event|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2
+ Avastin 15 mg/kg
Q 3 weeks X 4 cycles
Bevacizumab/Avastin: IV 15mg/kg 21 days
Cyclophosphamide: 500mg per meter squared, IV every 21 days
Doxorubicin: 60 mg per meter squared, IV every 21 days"
308027|NCT00203892|B4|Baseline|Total|Total of all reporting groups
308028|NCT00203892|B3|Baseline|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308029|NCT00203892|B2|Baseline|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308030|NCT00203892|B1|Baseline|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308923|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
308032|NCT00203892|P2|Participant Flow|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308033|NCT00203892|P1|Participant Flow|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308034|NCT00203892|O3|Outcome|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308035|NCT00203892|O2|Outcome|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308036|NCT00203892|O1|Outcome|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308037|NCT00203892|O3|Outcome|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308038|NCT00203892|O2|Outcome|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308039|NCT00203892|O1|Outcome|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308096|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
328524|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
308040|NCT00203892|E3|Reported Event|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308041|NCT00203892|E2|Reported Event|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308042|NCT00203892|E1|Reported Event|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
308043|NCT00203931|B3|Baseline|Total|Total of all reporting groups
308044|NCT00203931|B2|Baseline|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
308045|NCT00203931|B1|Baseline|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
308046|NCT00203931|P2|Participant Flow|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
308047|NCT00203931|P1|Participant Flow|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
308048|NCT00203931|O2|Outcome|Good Prognosis|"VeriStrat assigned classification based on mass spectrometry-based assay of serum samples collect at baseline. Details of how this was done is provided in Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. by Taguchi et al. in J Natl Cancer Inst 2007 99(11): 838-46."
308049|NCT00203931|O1|Outcome|Poor Prognosis|"VeriStrat assigned classification based on mass spectrometry-based assay of serum samples collect at baseline. Details of how this was done is provided in Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. by Taguchi et al. in J Natl Cancer Inst 2007 99(11): 838-46."
308050|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
308051|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
308052|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
308053|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
308054|NCT00203931|O2|Outcome|No Early Rash|Absence of rash (grade 1 or higher) by day 21 of cetuximab therapy
308055|NCT00203931|O1|Outcome|Early Rash|Presence of rash (grade 1 or higher) by day 21 of cetuximab therapy
308056|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
308058|NCT00203931|E2|Reported Event|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
308059|NCT00203931|E1|Reported Event|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
308060|NCT00203996|B7|Baseline|Total|Total of all reporting groups
308061|NCT00203996|B6|Baseline|Aim 3: All Participants|Includes groups randomized to any experimental ordering in Aim 3
308062|NCT00203996|B5|Baseline|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
308063|NCT00203996|B4|Baseline|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
308064|NCT00203996|B3|Baseline|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
308065|NCT00203996|B2|Baseline|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
308066|NCT00203996|B1|Baseline|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
308067|NCT00203996|P10|Participant Flow|Aim 3: Baseline - SWS Supp - REM Frag|"Each subject was assessed under three experimental conditions in the following order.
Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.
SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed."
308068|NCT00203996|P9|Participant Flow|Aim 3: SWS Supp - REM Frag - Baseline|"Each subject was assessed under three experimental conditions in the following order.
SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention."
308069|NCT00203996|P8|Participant Flow|Aim 3: Baseline - REM Frag - SWS Supp|"Each subject was assessed under three experimental conditions in the following order.
Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.
REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed."
308070|NCT00203996|P7|Participant Flow|Aim 3: REM Frag - Baseline - SWS Supp|"Each subject was assessed under three experimental conditions in the following order.
REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.
SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed."
308071|NCT00203996|P6|Participant Flow|Aim 3: REM Frag - SWS Supp - Baseline|"Each subject was assessed under three experimental conditions in the following order.
REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention."
308072|NCT00203996|P5|Participant Flow|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
308073|NCT00203996|P4|Participant Flow|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
308074|NCT00203996|P3|Participant Flow|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
308075|NCT00203996|P2|Participant Flow|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
308076|NCT00203996|P1|Participant Flow|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
308077|NCT00203996|O2|Outcome|Aim 3: SWS Suppression|Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
308078|NCT00203996|O1|Outcome|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
308079|NCT00203996|O2|Outcome|Aim 3: SWS Suppression|Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
308080|NCT00203996|O1|Outcome|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
308081|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
308082|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
308083|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
308084|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
308085|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
308086|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
308087|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
308088|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
308089|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
308090|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
308091|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
308092|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
308093|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
308094|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
308095|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
308211|NCT00197106|B2|Baseline|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308097|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
308098|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
308099|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
308100|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
308101|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
308102|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
308103|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
308104|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
308105|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
308106|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
308107|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
308108|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
308109|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
308110|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
308111|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
308112|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
308113|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
308114|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
308115|NCT00203996|E7|Reported Event|Aim 3: SWS Suppression|SWS: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
308116|NCT00203996|E6|Reported Event|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
308117|NCT00203996|E5|Reported Event|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
308118|NCT00203996|E4|Reported Event|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
308119|NCT00203996|E3|Reported Event|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
308120|NCT00203996|E2|Reported Event|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
308121|NCT00203996|E1|Reported Event|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
308122|NCT00204373|B1|Baseline|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
308123|NCT00204373|P1|Participant Flow|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
308124|NCT00204373|O1|Outcome|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
308125|NCT00204373|O1|Outcome|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
308126|NCT00204373|E1|Reported Event|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
308127|NCT00185588|B5|Baseline|Total|Total of all reporting groups
308128|NCT00185588|B4|Baseline|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308129|NCT00185588|B3|Baseline|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308212|NCT00197106|B1|Baseline|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308130|NCT00185588|B2|Baseline|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308131|NCT00185588|B1|Baseline|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308132|NCT00185588|P4|Participant Flow|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308133|NCT00185588|P3|Participant Flow|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308134|NCT00185588|P2|Participant Flow|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308135|NCT00185588|P1|Participant Flow|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308136|NCT00185588|O4|Outcome|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308137|NCT00185588|O3|Outcome|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308138|NCT00185588|O2|Outcome|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308139|NCT00185588|O1|Outcome|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308140|NCT00185588|O4|Outcome|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308141|NCT00185588|O3|Outcome|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308142|NCT00185588|O2|Outcome|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308143|NCT00185588|O1|Outcome|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308144|NCT00185588|E4|Reported Event|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308145|NCT00185588|E3|Reported Event|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308146|NCT00185588|E2|Reported Event|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
315861|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
308147|NCT00185588|E1|Reported Event|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2"
308148|NCT00185679|B1|Baseline|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
The CliniMACS System is a cell selection device consisting of the following components:
Computer-controlled instrument;
Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
Wash buffer"
308149|NCT00185679|P1|Participant Flow|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:
Computer-controlled instrument;
Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
Wash buffer"
308150|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:
Computer-controlled instrument;
Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
Wash buffer"
308151|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:
Computer-controlled instrument;
Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
Wash buffer"
308213|NCT00197106|P3|Participant Flow|FP 200 mcg|FP 200 mcg (delivered as two 100 mcg puffs) BID via DISKUS inhaler
328525|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
308152|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:
Computer-controlled instrument;
Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
Wash buffer"
308153|NCT00185679|E1|Reported Event|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:
Computer-controlled instrument;
Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
Wash buffer"
308154|NCT00185692|B1|Baseline|Transplating of CD34+ Selected Hematopietic Cells|
308155|NCT00185692|P1|Participant Flow|Transplating of CD34+ Selected Hematopietic Cells|
308156|NCT00185692|O1|Outcome|Transplantation of CD34+ Cells|"Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.
Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.
non-myeloablative hematopoietic cell transplantation: TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.
Anti-Thymocyte Globulin: 1.5 mg/kg QD x 5, IV. Dosage will be based on body weight.
Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.
Cyclosporine: 6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).
Mycophenolate Mofetil: 15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively"
308157|NCT00185692|O1|Outcome|Transplantation of CD34+ Cells|"Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.
Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.
non-myeloablative hematopoietic cell transplantation: TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.
Anti-Thymocyte Globulin: 1.5 mg/kg QD x 5, IV. Dosage will be based on body weight.
Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.
Cyclosporine: 6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).
Mycophenolate Mofetil: 15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively"
308158|NCT00185692|E1|Reported Event|Transplating of CD34+ Selected Hematopietic Cells|
308159|NCT00185965|B3|Baseline|Total|Total of all reporting groups
308160|NCT00185965|B2|Baseline|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)
CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
308161|NCT00185965|B1|Baseline|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)
CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
308162|NCT00185965|P2|Participant Flow|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)
CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
308163|NCT00185965|P1|Participant Flow|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)
CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
308164|NCT00185965|O2|Outcome|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)
CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
308165|NCT00185965|O1|Outcome|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)
CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
308166|NCT00185965|E2|Reported Event|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)
CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
308167|NCT00185965|E1|Reported Event|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)
CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
308168|NCT00186017|B3|Baseline|Total|Total of all reporting groups
308169|NCT00186017|B2|Baseline|Placebo|"Placebo
Olanzapine/Zyprexa"
308170|NCT00186017|B1|Baseline|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa"
308171|NCT00186017|P2|Participant Flow|Placebo|"Placebo
Olanzapine/Zyprexa"
308172|NCT00186017|P1|Participant Flow|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa"
308173|NCT00186017|O2|Outcome|Placebo|Placebo
309172|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
308174|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
308175|NCT00186017|O2|Outcome|Placebo|Placebo
308176|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
308177|NCT00186017|O2|Outcome|Placebo|Placebo
308178|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
308179|NCT00186017|O2|Outcome|Placebo|Placebo up to 8 per day for 1 week
308180|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
308181|NCT00186017|E2|Reported Event|Placebo|Placebo taken in same manner as study drug up to 8 per day for 1 week
308182|NCT00186017|E1|Reported Event|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
308183|NCT00186056|B3|Baseline|Total|Total of all reporting groups
308184|NCT00186056|B2|Baseline|Placebo|"Patients received placebo for 6 days
Mifepristone: Glucocorticoid antagonist"
308185|NCT00186056|B1|Baseline|Mifepristone|"Patients received mifepristone for 6 days
Mifepristone: Glucocorticoid antagonist"
308186|NCT00186056|P2|Participant Flow|Placebo|"Patients received placebo for 6 days
Mifepristone: Glucocorticoid antagonist"
308187|NCT00186056|P1|Participant Flow|Mifepristone|"Patients received mifepristone for 6 days
Mifepristone: Glucocorticoid antagonist"
308188|NCT00186056|O2|Outcome|Placebo|"Patients received placebo for 6 days
Mifepristone: Glucocorticoid antagonist"
308189|NCT00186056|O1|Outcome|Mifepristone|"Patients received mifepristone for 6 days
Mifepristone: Glucocorticoid antagonist"
308190|NCT00186056|E2|Reported Event|Placebo|"Patients received placebo for 6 days
Mifepristone: Glucocorticoid antagonist"
308191|NCT00186056|E1|Reported Event|Mifepristone|"Patients received mifepristone for 6 days
Mifepristone: Glucocorticoid antagonist"
308192|NCT00186069|B3|Baseline|Total|Total of all reporting groups
308193|NCT00186069|B2|Baseline|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour
Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
308194|NCT00186069|B1|Baseline|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
308195|NCT00186069|P2|Participant Flow|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour
Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
308196|NCT00186069|P1|Participant Flow|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
308197|NCT00186069|O2|Outcome|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour
Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
315862|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
308198|NCT00186069|O1|Outcome|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
308199|NCT00186069|O2|Outcome|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour
Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
308200|NCT00186069|O1|Outcome|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
308201|NCT00186069|O2|Outcome|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour
Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
308202|NCT00186069|O1|Outcome|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
308203|NCT00186069|E2|Reported Event|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour
Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
308204|NCT00186069|E1|Reported Event|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
308205|NCT00186186|B1|Baseline|Depakote ER|"Depakote ER up to 1500 mg/day
Depakote ER: Depakote ER"
308206|NCT00186186|P1|Participant Flow|Depakote ER|Open-label. All subjects received Depakote extended release (ER) starting 250mg/daily at bedtime. Dose was increased every 4 days by 250mg/day as necessary and tolerated up to 1500 mg/day. All subjects took medication over a period of 7 weeks or terminated at the final visit (whichever came first).
308207|NCT00186186|O1|Outcome|Depakote ER|Open-label. All subjects received Depakote extended release (ER) starting 250mg/daily at bedtime. Dose was increased every 4 days by 250mg/day as necessary and tolerated up to 1500 mg/day. All subjects took medication over a period of 7 weeks or terminated at the final visit (whichever came first).
308208|NCT00186186|O1|Outcome|Depakote ER|Depakote ER up to 1500 mg/day
308209|NCT00186186|E1|Reported Event|Depakote ER|Depakote ER up to 1500 mg/day
308210|NCT00197106|B3|Baseline|Total|Total of all reporting groups
308214|NCT00197106|P2|Participant Flow|Salmeterol/FP 50/100 mcg Plus Placebo|One puff Salmeterol/FP 50/100 mcg plus one puff placebo (matching one puff of FP in the 200 mcg group) BID via DISKUS inhaler
308215|NCT00197106|P1|Participant Flow|Fluticasone Propionate (FP) 100 mcg|Fluticasone propionate (FP) 100 mcg (micrograms) twice daily (BID) via DISKUS inhaler
308216|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308217|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308218|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308219|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308220|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308221|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308222|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308223|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308224|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308225|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308226|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308227|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308228|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308229|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308230|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308231|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308232|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308233|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308234|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308235|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308236|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308237|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308238|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308239|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308240|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308241|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308242|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308243|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308244|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308245|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308246|NCT00197106|E2|Reported Event|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
308247|NCT00197106|E1|Reported Event|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
308248|NCT00197119|B3|Baseline|Total|Total of all reporting groups
308391|NCT00198042|B1|Baseline|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
308249|NCT00197119|B2|Baseline|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
308250|NCT00197119|B1|Baseline|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
308251|NCT00197119|P2|Participant Flow|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
308252|NCT00197119|P1|Participant Flow|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
308253|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
308254|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
308255|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
308256|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
308257|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
308258|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
308259|NCT00197119|E2|Reported Event|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
308260|NCT00197119|E1|Reported Event|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
308261|NCT00197184|B3|Baseline|Total|Total of all reporting groups
308262|NCT00197184|B2|Baseline|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308263|NCT00197184|B1|Baseline|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308264|NCT00197184|P2|Participant Flow|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308265|NCT00197184|P1|Participant Flow|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308266|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308267|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308268|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308269|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308270|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308271|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308272|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308273|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308274|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308275|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308276|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308277|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308278|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308279|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308280|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308281|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308282|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308283|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308284|NCT00197184|E2|Reported Event|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
308285|NCT00197184|E1|Reported Event|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
308286|NCT00197236|B4|Baseline|Total|Total of all reporting groups
308287|NCT00197236|B3|Baseline|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308288|NCT00197236|B2|Baseline|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308289|NCT00197236|B1|Baseline|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308290|NCT00197236|P3|Participant Flow|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308291|NCT00197236|P2|Participant Flow|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308292|NCT00197236|P1|Participant Flow|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308390|NCT00198029|E1|Reported Event|Open Label Group|Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
308293|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308294|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308295|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308296|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308297|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308298|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308299|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308300|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308301|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308302|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308303|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308304|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308305|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308306|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308307|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308308|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
309173|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
308309|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308310|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308311|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308312|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308313|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308314|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308315|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308316|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308317|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308318|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308319|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308320|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308321|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308322|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308323|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308324|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308325|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308326|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308327|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308328|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308329|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308330|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308331|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308332|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308333|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308334|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308335|NCT00197236|E3|Reported Event|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
308336|NCT00197236|E2|Reported Event|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
308337|NCT00197236|E1|Reported Event|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
308338|NCT00197392|B3|Baseline|Total|Total of all reporting groups
308339|NCT00197392|B2|Baseline|Standard EVD|
308340|NCT00197392|B1|Baseline|Bactiseal EVD|
308341|NCT00197392|P2|Participant Flow|Conventional EVD Catheter|Subjects treated with Standard EVD catheter
308342|NCT00197392|P1|Participant Flow|Bactiseal EVD|Subjects treated with Bactiseal EVD catheter
308343|NCT00197392|O2|Outcome|Standard EVD|Subjects implanted with Standard EVD catheters.
308344|NCT00197392|O1|Outcome|Bactiseal EVD|Subjects implanted with Bactiseal EVD catheters.
308345|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with a standard EVD catheter
308346|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
308347|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with a standard EVD catheter
308348|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with the Bactiseal EVD Catheter
308349|NCT00197392|O2|Outcome|Standrad EVD Catheter|Subjects implanted with standard EVD catheter
308350|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
308351|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects treated with standard EVD catheter
308352|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects treated with Bactiseal EVD Catheter
308353|NCT00197392|O1|Outcome|Bactiseal EVD Catheter and Standard EVD Cathter|Patients implanted with Bactiseal EVD Catheter or Standard EVD Catheter.
308354|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with standard EVD catheter
308355|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
308356|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with Standard EVD Catheter
308357|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
308358|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with standard EVD catheter
308359|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
308360|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with Standard EVD Catheter
308361|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
308362|NCT00197392|O2|Outcome|Standard EVD Catheter|Patient treated with Standard EVD Catheter
308363|NCT00197392|O1|Outcome|Bactiseal - EVD Catheter|Patients treated with Bactiseal EVD catheter
308364|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients treated with standard EVD catheter.
308365|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients treated with Codman Bactiseal EVD Catheter
308366|NCT00197392|O2|Outcome|Standard EVD Cathter|Patients treated with Standard EVD Catheter
308367|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients treated with Codman Bactiseal EVD Catheter
308368|NCT00197392|E2|Reported Event|Bactiseal EVD|Subjects with Bactiseal EVD
308369|NCT00197392|E1|Reported Event|Standard EVD|Subjects with standard EVD
308370|NCT00197496|B3|Baseline|Total|Total of all reporting groups
308371|NCT00197496|B2|Baseline|Control|Usual care
308372|NCT00197496|B1|Baseline|BWSTT|Body weight supported treadmill training
308373|NCT00197496|P2|Participant Flow|Control|Usual care
308374|NCT00197496|P1|Participant Flow|BWSTT|Body weight supported treadmill training
308375|NCT00197496|O2|Outcome|Control|Usual care
308376|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
308377|NCT00197496|O2|Outcome|Control|Usual care
308378|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
308379|NCT00197496|O2|Outcome|Control|Usual care
308380|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
308381|NCT00197496|O2|Outcome|Control|Usual care
308382|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
308383|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
308384|NCT00197496|E2|Reported Event|Usual Care|Usual care rehabilitation
308385|NCT00197496|E1|Reported Event|BWSTT|Body weight supported treadmill training: hip fracture patients walk on a treadmill with body weight support
308386|NCT00198029|B1|Baseline|Open Label Group|Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
308387|NCT00198029|P1|Participant Flow|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
308388|NCT00198029|O1|Outcome|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
308389|NCT00198029|O1|Outcome|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
308392|NCT00198042|P1|Participant Flow|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
308393|NCT00198042|O1|Outcome|All Patients|Tunnel expansion after ACL-R occurs early and primarily at the tunnel apertures. Expansion may not affect clinical outcome. Younger age, male sex, and delay from injury to ACL-R may be potential risks for enlargement.
308394|NCT00198042|E1|Reported Event|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
308395|NCT00198081|B3|Baseline|Total|Total of all reporting groups
308396|NCT00198081|B2|Baseline|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
308397|NCT00198081|B1|Baseline|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308398|NCT00198081|P2|Participant Flow|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
308399|NCT00198081|P1|Participant Flow|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308400|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308401|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308402|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308403|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308404|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308405|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308406|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308407|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308408|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308409|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308410|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308411|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308412|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308413|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308414|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308415|NCT00198081|O2|Outcome|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
308416|NCT00198081|O1|Outcome|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308417|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308418|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308419|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308420|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308421|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308422|NCT00198081|E2|Reported Event|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
308423|NCT00198081|E1|Reported Event|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery
COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
308424|NCT00198133|B3|Baseline|Total|Total of all reporting groups
308425|NCT00198133|B2|Baseline|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308426|NCT00198133|B1|Baseline|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308427|NCT00198133|P2|Participant Flow|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308428|NCT00198133|P1|Participant Flow|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308429|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308430|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308431|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308432|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308433|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308434|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308435|NCT00198133|E2|Reported Event|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308436|NCT00198133|E1|Reported Event|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
308437|NCT00198822|B4|Baseline|Total|Total of all reporting groups
308438|NCT00198822|B3|Baseline|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
308439|NCT00198822|B2|Baseline|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
308440|NCT00198822|B1|Baseline|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
308441|NCT00198822|P3|Participant Flow|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
308442|NCT00198822|P2|Participant Flow|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
308443|NCT00198822|P1|Participant Flow|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
308444|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
308445|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
308446|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
308447|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
308448|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
328526|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
308449|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
308450|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
308451|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
308452|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
308453|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
308454|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
308455|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
308456|NCT00198822|E3|Reported Event|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
308457|NCT00198822|E2|Reported Event|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
308458|NCT00198822|E1|Reported Event|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
308459|NCT00204932|B3|Baseline|Total|Total of all reporting groups
308460|NCT00204932|B2|Baseline|Placebo|3 grams per day of sunflower oil for 7 months
308461|NCT00204932|B1|Baseline|Conjugated Linoleic Acid|3 grams per day for 7 months
308462|NCT00204932|P2|Participant Flow|Placebo|4 grams per day of sunflower oil for 6 months
308463|NCT00204932|P1|Participant Flow|Conjugated Linoleic Acid|4 grams per day of 78% CLA for 6 months
308464|NCT00204932|O2|Outcome|Placebo|3 grams per day of sunflower oil for 7 months
308465|NCT00204932|O1|Outcome|Conjugated Linoleic Acid|3 grams per day for 7 months
308466|NCT00204932|E2|Reported Event|Placebo|4 grams per day of sunflower oil for 6 months
308467|NCT00204932|E1|Reported Event|Conjugated Linoleic Acid|4 grams of 78% active CLA per day for 6 months
308468|NCT00205049|B3|Baseline|Total|Total of all reporting groups
308469|NCT00205049|B2|Baseline|Placebo|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
308470|NCT00205049|B1|Baseline|Pentoxifylline|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
308471|NCT00205049|P2|Participant Flow|Placebo|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
308472|NCT00205049|P1|Participant Flow|Pentoxifylline|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
308473|NCT00205049|O2|Outcome|Placebo|
308474|NCT00205049|O1|Outcome|Pentoxifylline|
308475|NCT00205049|E2|Reported Event|Placebo|
308476|NCT00205049|E1|Reported Event|Pentoxifylline|
308477|NCT00209339|B1|Baseline|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308478|NCT00209339|P1|Participant Flow|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308479|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308480|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308481|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308482|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308483|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308484|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308485|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308486|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308487|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308488|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308652|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308489|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308490|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308491|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308492|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308493|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308494|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308495|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308496|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308497|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308498|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308499|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308500|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308501|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308502|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308503|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308504|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308559|NCT00209417|B3|Baseline|Total|Total of all reporting groups
308505|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308506|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308507|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308508|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308509|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308510|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308511|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308512|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308513|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308514|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308515|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308516|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308517|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308518|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308519|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308520|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308521|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308522|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308523|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308524|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308525|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308526|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308527|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308528|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308529|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308530|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308531|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308532|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308533|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308534|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308535|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308536|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308537|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308538|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308539|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308540|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308541|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308542|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308543|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308544|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308545|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308546|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308547|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308548|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308549|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308550|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308551|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308552|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308553|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308554|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308555|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308556|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308557|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308558|NCT00209339|E1|Reported Event|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
308562|NCT00209417|P2|Participant Flow|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL
Iopamidol 300-Arm 2"
308563|NCT00209417|P1|Participant Flow|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL
Iodixanol 320-Arm 1"
308564|NCT00209417|O2|Outcome|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL
Iopamidol 300-Arm 2"
308565|NCT00209417|O1|Outcome|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL
Iodixanol 320-Arm 1"
308566|NCT00209417|O2|Outcome|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL
Iopamidol 300-Arm 2"
308567|NCT00209417|O1|Outcome|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL
Iodixanol 320-Arm 1"
308568|NCT00209417|E2|Reported Event|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL
Iopamidol 300-Arm 2"
308569|NCT00209417|E1|Reported Event|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL
Iodixanol 320-Arm 1"
308570|NCT00209560|B3|Baseline|Total|Total of all reporting groups
308571|NCT00209560|B2|Baseline|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
308572|NCT00209560|B1|Baseline|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
308573|NCT00209560|P2|Participant Flow|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
308574|NCT00209560|P1|Participant Flow|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
308575|NCT00209560|O2|Outcome|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
308576|NCT00209560|O1|Outcome|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
308577|NCT00209560|O2|Outcome|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
308578|NCT00209560|O1|Outcome|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
308579|NCT00209560|E2|Reported Event|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
308580|NCT00209560|E1|Reported Event|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
308581|NCT00210470|B1|Baseline|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
308582|NCT00210470|P1|Participant Flow|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
308583|NCT00210470|O1|Outcome|IRX-2 Regimen|A 2-week course of IRX-2, an initial low dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation
308584|NCT00210470|E1|Reported Event|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
308585|NCT00210626|B3|Baseline|Total|Total of all reporting groups
308586|NCT00210626|B2|Baseline|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
308587|NCT00210626|B1|Baseline|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
308588|NCT00210626|P2|Participant Flow|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
308589|NCT00210626|P1|Participant Flow|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
308590|NCT00210626|O2|Outcome|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
308591|NCT00210626|O1|Outcome|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
308592|NCT00210626|O2|Outcome|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
308593|NCT00210626|O1|Outcome|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
308594|NCT00210626|E2|Reported Event|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
308595|NCT00210626|E1|Reported Event|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
308596|NCT00210639|B3|Baseline|Total|Total of all reporting groups
308597|NCT00210639|B2|Baseline|Comparator|Participants who received comparator in the previous studies.
308598|NCT00210639|B1|Baseline|Levofloxacin|Participants who received levofloxacin in the previous studies.
308599|NCT00210639|P2|Participant Flow|Comparator|Participants who received comparator in the previous studies.
308600|NCT00210639|P1|Participant Flow|Levofloxacin|Participants who received levofloxacin in the previous studies.
308601|NCT00210639|O2|Outcome|Comparator|Participants who received comparator in the previous studies.
308602|NCT00210639|O1|Outcome|Levofloxacin|Participants who received levofloxacin in the previous studies.
308603|NCT00210639|E2|Reported Event|Comparator|Participants who received comparator in the previous studies.
308604|NCT00210639|E1|Reported Event|Levofloxacin|Participants who received levofloxacin in the previous studies.
308605|NCT00211081|B1|Baseline|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
308606|NCT00211081|P1|Participant Flow|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
308607|NCT00211081|O1|Outcome|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
308608|NCT00211081|E1|Reported Event|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
308610|NCT00211172|B2|Baseline|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
308611|NCT00211172|B1|Baseline|Usual Care|Usual care patients were not contacted by the study.
308612|NCT00211172|P2|Participant Flow|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
308613|NCT00211172|P1|Participant Flow|Usual Care|Usual care patients were not contacted by the study.
308614|NCT00211172|O2|Outcome|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
308615|NCT00211172|O1|Outcome|Usual Care|Usual care patients were not contacted by the study.
308758|NCT00211692|E1|Reported Event|Overall|
308616|NCT00211172|E2|Reported Event|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
308617|NCT00211172|E1|Reported Event|Usual Care|Usual care patients were not contacted by the study.
308618|NCT00211237|B3|Baseline|Total|Total of all reporting groups
308619|NCT00211237|B2|Baseline|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308620|NCT00211237|B1|Baseline|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308621|NCT00211237|P3|Participant Flow|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308622|NCT00211237|P2|Participant Flow|Non-surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308623|NCT00211237|P1|Participant Flow|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308624|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308625|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308626|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308627|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308628|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308629|NCT00211237|O4|Outcome|Crossover-(AEs Collected After BKP)|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308630|NCT00211237|O3|Outcome|Crossover (AEs Collected Before BKP)|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308631|NCT00211237|O2|Outcome|Non Surgical Management|The subjects were randomized to NSM without crossing over.
308632|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects were randomized to Balloon Kyphoplasty.
308633|NCT00211237|O2|Outcome|Non Surgical Management|The subjects were randomized to NSM.
308634|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects were randomized to the Balloon Kyphoplasty.
308635|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308636|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308637|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308638|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308639|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308640|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308641|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308642|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308643|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308644|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308645|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308646|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308647|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308648|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308649|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308650|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308651|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308653|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308654|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308655|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308656|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308657|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308658|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308659|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308660|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308661|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308662|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308663|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308664|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308665|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308666|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308667|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308668|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308669|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308670|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308671|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308672|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308673|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308674|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308675|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308992|NCT00214019|O1|Outcome|Placebo/Placebo|Participants on Placebo/Placebo arm
308676|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308677|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308678|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308679|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308680|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308681|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308682|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308683|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308684|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308685|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308686|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308687|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308688|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308759|NCT00185380|B4|Baseline|Total|Total of all reporting groups
308689|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308690|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308691|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308692|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308693|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308694|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308695|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308696|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308697|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308698|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308699|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308700|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308701|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308702|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308703|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308704|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308705|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
308706|NCT00211237|O2|Outcome|Non-Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308707|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
308708|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308709|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
308710|NCT00211237|E2|Reported Event|Non Surgical Management|The subjects in this group will undergo the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
308711|NCT00211237|E1|Reported Event|Balloon Kyphoplasty|The subjects assigned to this group will undergo the treatment with Balloon kyphoplasty for their painful VCFs.
308713|NCT00211510|B2|Baseline|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
308714|NCT00211510|B1|Baseline|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
308715|NCT00211510|P2|Participant Flow|Paradigm 715 Insulin Pump|subjects with use the Paradigm 715 insulin pump for insulin infusion
308716|NCT00211510|P1|Participant Flow|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
308717|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
308718|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 711 sensor augmented pump for insulin infusion and continuous glucose monitoring
308719|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
308720|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
308721|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
308722|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects with use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
308723|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
308724|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
308725|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 pump for insulin infusion
308726|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
308727|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
308728|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
308729|NCT00211510|E2|Reported Event|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
308730|NCT00211510|E1|Reported Event|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
308731|NCT00211536|B3|Baseline|Total|Total of all reporting groups
308732|NCT00211536|B2|Baseline|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308733|NCT00211536|B1|Baseline|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308734|NCT00211536|P2|Participant Flow|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308735|NCT00211536|P1|Participant Flow|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308736|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308924|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
308925|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
308926|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
308737|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308738|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308739|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308760|NCT00185380|B3|Baseline|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
308761|NCT00185380|B2|Baseline|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
328527|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
308740|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308741|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308742|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308743|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308744|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308927|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
308928|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
308929|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
308930|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
308745|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
308746|NCT00211536|E2|Reported Event|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group. All randomized subjects were assessed for safety risk."
308747|NCT00211536|E1|Reported Event|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.
Results were analyzed for subjects that completed beyond V5, which was the end of the first 90 day period of IP insulin therapy. These were considered to be the As Treated group.
All randomized subjects were assessed for safety risk."
308748|NCT00211692|B3|Baseline|Total|Total of all reporting groups
308749|NCT00211692|B2|Baseline|Group B Duration Based on Viral Response|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
308750|NCT00211692|B1|Baseline|Group A 52 Weeks Treatment|Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
308751|NCT00211692|P2|Participant Flow|Group B Duration Based on Viral Response|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
308752|NCT00211692|P1|Participant Flow|Group A 52 Weeks Treatment|Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
308753|NCT00211692|O1|Outcome|Overall|
308754|NCT00211692|O1|Outcome|Overall|
308755|NCT00211692|O1|Outcome|Overall|
308756|NCT00211692|O2|Outcome|B (Duration Based on Viral Response)|
308757|NCT00211692|O1|Outcome|A (52 Weeks Treatment)|
308762|NCT00185380|B1|Baseline|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
308763|NCT00185380|P3|Participant Flow|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
308764|NCT00185380|P2|Participant Flow|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
308765|NCT00185380|P1|Participant Flow|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
308766|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
308767|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
308768|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
308769|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
308770|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
308771|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
308772|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
308773|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
308774|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
308775|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
308776|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
308777|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
308778|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
308779|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
308780|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
308781|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
308782|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
308783|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
308784|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
308785|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
308786|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
308787|NCT00185380|E3|Reported Event|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
308788|NCT00185380|E2|Reported Event|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
308789|NCT00185380|E1|Reported Event|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
308931|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
308932|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
308790|NCT00185458|B1|Baseline|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
308791|NCT00185458|P1|Participant Flow|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
308792|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308793|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308794|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308795|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308796|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308797|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308798|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308799|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308800|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308801|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308802|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308803|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308804|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308805|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308806|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308807|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308808|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308809|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308810|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308811|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308812|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308813|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308814|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308815|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308816|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308817|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308818|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308819|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308820|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308821|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308822|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308823|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308824|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308825|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308826|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308827|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308828|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308829|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308830|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308831|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308832|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308833|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
309109|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
308834|NCT00185458|O1|Outcome|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
308835|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
308836|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
308837|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
308838|NCT00185458|O1|Outcome|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
308839|NCT00185458|O5|Outcome|Reference Period 4 (HRT Phase)|Patient assessment within day 271 to 360 of the HRT phase
308840|NCT00185458|O4|Outcome|Reference Period 3 (HRT Phase)|Patient assessment within day 181 to 270 of the HRT phase
308841|NCT00185458|O3|Outcome|Reference Period 2 (HRT Phase)|Patient assessment within day 91 to 180 of the HRT phase
308842|NCT00185458|O2|Outcome|Reference Period 1 (HRT Phase)|Patient assessment within the first 90-days of the HRT phase
308843|NCT00185458|O1|Outcome|Reference Period -1 (Contraception Phase)|Patient assessment within the last 90-days before starting the HRT
308844|NCT00185458|O5|Outcome|Reference Period 4 (HRT Phase)|Patient assessment within day 271 to 360 of the HRT phase
308845|NCT00185458|O4|Outcome|Reference Period 3 (HRT Phase)|Patient assessment within day 181 to 270 of the HRT phase
308846|NCT00185458|O3|Outcome|Reference Period 2 (HRT Phase)|Patient assessment within day 91 to 180 of the HRT phase
308847|NCT00185458|O2|Outcome|Reference Period 1 (HRT Phase)|Patient assessment within the first 90-days of the HRT phase
308848|NCT00185458|O1|Outcome|Reference Period -1 (Contraception Phase)|Patient assessment within the last 90-days before starting the HRT
328528|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
308849|NCT00185458|E1|Reported Event|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
308850|NCT00201825|B1|Baseline|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
308851|NCT00201825|P1|Participant Flow|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
308852|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
308853|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
308854|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
308855|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
308856|NCT00201825|E1|Reported Event|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
308857|NCT00201838|B3|Baseline|Total|Total of all reporting groups
308858|NCT00201838|B2|Baseline|Control Arm|Patients received Gemcitabine alone
308859|NCT00201838|B1|Baseline|Interventional Arm|Patients received Etanercept with gemcitabine
308860|NCT00201838|P2|Participant Flow|Control Group|Patients received gemcitabine alone
308861|NCT00201838|P1|Participant Flow|Experimental Group|"combination of gemcitabine and etanercept
Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.
Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
308933|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
308934|NCT00211887|E3|Reported Event|Glatiramer|glatiramer acetate
308935|NCT00211887|E2|Reported Event|IFB-1a|Interferon beta-1a
308862|NCT00201838|O2|Outcome|Non Responders|"Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.
Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
308863|NCT00201838|O1|Outcome|Responders|"combination of gemcitabine and etanercept
Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.
Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
308864|NCT00201838|O2|Outcome|Control Group|gemcitabine alone
308865|NCT00201838|O1|Outcome|Experimental Group|"combination of gemcitabine and etanercept
Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.
Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
308866|NCT00201838|O2|Outcome|Control Group|Gemcitabine alone
308867|NCT00201838|O1|Outcome|Experimental Group|Etanercept with gemcitabine
308868|NCT00201838|O2|Outcome|Control Group|Patients received gemcitabine alone
308869|NCT00201838|O1|Outcome|Experimental Group|"combination of gemcitabine and etanercept
Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.
Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
308870|NCT00201838|O2|Outcome|Control Group|Patients received gemcitabine alone
308871|NCT00201838|O1|Outcome|Experimental Group|Patients received etanercept 25mg subcutaneously twice-weekly with gemcitabine
308872|NCT00201838|E2|Reported Event|Control Group|Patients in the control cohort received gemcitabine alone.
308873|NCT00201838|E1|Reported Event|Experimental Group|Patients in the experimental group received etancercept 25 mg subcutaneously twice-weekly with gemcitabine.
308874|NCT00201851|B4|Baseline|Total|Total of all reporting groups
308875|NCT00201851|B3|Baseline|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
308876|NCT00201851|B2|Baseline|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
328529|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
308877|NCT00201851|B1|Baseline|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
308878|NCT00201851|P3|Participant Flow|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
308879|NCT00201851|P2|Participant Flow|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
308880|NCT00201851|P1|Participant Flow|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
308881|NCT00201851|O3|Outcome|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
308882|NCT00201851|O2|Outcome|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
308883|NCT00201851|O1|Outcome|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
308936|NCT00211887|E1|Reported Event|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
308884|NCT00201851|E3|Reported Event|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
308885|NCT00201851|E2|Reported Event|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
308886|NCT00201851|E1|Reported Event|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
308887|NCT00201864|B1|Baseline|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
Exemestane: 25 mg orally per day
Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
308888|NCT00201864|P1|Participant Flow|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
Exemestane: 25 mg orally per day
Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
308889|NCT00201864|O2|Outcome|IGFBP-3|IGFBP-3-insulin-like growth factor-binding
308890|NCT00201864|O1|Outcome|IGF-1|IGF-1-insulin-like growth factor
308891|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
Exemestane: 25 mg orally per day
Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
308892|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
Exemestane: 25 mg orally per day
Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
308893|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
Exemestane: 25 mg orally per day
Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
308894|NCT00201864|E1|Reported Event|Single-arm Study|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
Exemestane: 25 mg orally per day
Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
308895|NCT00201877|B1|Baseline|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.
Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
308896|NCT00201877|P1|Participant Flow|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.
Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
308897|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.
Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
308898|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.
Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
308899|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.
Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
308900|NCT00201877|E1|Reported Event|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.
Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
308901|NCT00211809|B1|Baseline|Body Dysmorphic Disorder|Participants with body dysmorphic disorder
308902|NCT00211809|P1|Participant Flow|Body Dysmorphic Disorder|"Participants with body dysmorphic disorder
Standard Psychiatric Evaluation
Venlafaxine: start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks."
308903|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
308904|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
308905|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
308906|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
308907|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
308908|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
308909|NCT00211809|O1|Outcome|Body Dysmorphic Disorder|Participants with body dysmorphic disorder after Venlafaxine treatment up to 16 weeks
308910|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
308911|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
308912|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
308913|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
308914|NCT00211809|E1|Reported Event|Body Dysmorphic Disorder|Participants with body dysmorphic disorder
308915|NCT00211887|B4|Baseline|Total|Total of all reporting groups
308916|NCT00211887|B3|Baseline|Glatiramer|glatiramer acetate
308917|NCT00211887|B2|Baseline|IFB-1a|Interferon beta-1a
308918|NCT00211887|B1|Baseline|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
308919|NCT00211887|P3|Participant Flow|Glatiramer Acetate|glatiramer acetate 20mg daily
308920|NCT00211887|P2|Participant Flow|Interferon Beta 1a|Interferon beta-1a 30µg intramuscularly weekly
308921|NCT00211887|P1|Participant Flow|IFN + GA|Interferon beta-1a 30µg intramuscularly weekly and glatiramer acetate (GA) 20mg daily
308922|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
308938|NCT00212134|B2|Baseline|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens
INTERVENTION: aphakic intraocular lens"
308939|NCT00212134|B1|Baseline|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens
INTERVENTION: aphakic contact lens"
308940|NCT00212134|P2|Participant Flow|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens
INTERVENTION: aphakic intraocular lens"
308941|NCT00212134|P1|Participant Flow|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens
INTERVENTION: aphakic contact lens"
308942|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens
INTERVENTION: aphakic intraocular lens"
308943|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens
INTERVENTION: aphakic contact lens"
308944|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens
INTERVENTION: aphakic intraocular lens"
308945|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens
INTERVENTION: aphakic contact lens"
308946|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens
INTERVENTION: aphakic intraocular lens"
308947|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens
INTERVENTION: aphakic contact lens"
308948|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens
INTERVENTION: aphakic intraocular lens"
308949|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens
INTERVENTION: aphakic contact lens"
308950|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens
INTERVENTION: aphakic intraocular lens"
308951|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens
INTERVENTION: aphakic contact lens"
308974|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
308952|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens
INTERVENTION: At the time of surgery to remove the cataractous natural lens, an intraocular lens was implanted to correct the large hyperopic refractive error induced by the cataract surgery.
primary implantation of aphakic intraocular lens: optical correction of surgical aphakia with intraocular lens"
308953|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens
INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly.
hyperopic correction of infant surgical aphakia with Contact Lens: optical correction of infant surgical aphakia with Contact lens"
308954|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens
INTERVENTION: The refractive error induced by surgical removal of the cataractous natural lens is partially corrected by the implantation of an intraocular lens (IOL) at the time of surgery. This is deemed a permanent correction as the IOL may only be removed in a subsequent surgery."
308955|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens
INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly."
308956|NCT00212134|E2|Reported Event|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens
INTERVENTION: aphakic intraocular lens"
308957|NCT00212134|E1|Reported Event|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens
INTERVENTION: aphakic contact lens"
308958|NCT00212758|B1|Baseline|All Participants|Subjects will be randomized to either a low or standard arm. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months, re-evaluate growth velocity and then continue for another 6 months on GH.
308959|NCT00212758|P2|Participant Flow|Standard- Low- Standard GH|This group was randomized to receive 0.05 mg/kg/day of growth hormone for 7 doses given subcutaneously followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the low dose of 0.025 mg/kg/day for 7 days.
308960|NCT00212758|P1|Participant Flow|Low-standard-standard GH|This group was randomized to receive 0.025 mg/kg/day of growth hormone for 7 doses given subcutaneously, followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the standard dose of 0.05 mg/kg/day for 7 days.
308961|NCT00212758|O1|Outcome|All Participants|Subjects will be randomized to either a low or standard arm. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months, re-evaluate growth velocity and then continue for another 6 months on GH.
308962|NCT00212758|O2|Outcome|Standard Dose GH|Subjects will be randomized to either a low or standard arm. The Standard dose GH group will get 0.05 mg/kg/day of growth hormone therapy for 7 days followed by 2 week wash out and then another 7 days of GH therapy on the low dose of 0.025 mg/kg/dose given subcutaneously.
308963|NCT00212758|O1|Outcome|Low Dose GH|Subjects will be randomized to either a low or standard arm. The low dose GH group will get 0.025 mg/kg/day of growth hormone therapy for 7 days followed by 2 weeks of wash out and then another 7 days of GH therapy on the standard dose of 0.05 mg/kg/dose given subcutaneously.
308993|NCT00214019|E1|Reported Event|4 Way Cross Over|"Participants completed all 4 treatments:
Placebo Salmeterol diskus 50 mcg twice per day Placebo then Fluticasone Salmeterol then Fluticasone"
308994|NCT00214201|B3|Baseline|Total|Total of all reporting groups
308964|NCT00212758|E1|Reported Event|All Participants|There will be 2 arms in the study who will be randomized in a cross over design. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months.
308965|NCT00213135|B4|Baseline|Total|Total of all reporting groups
308966|NCT00213135|B3|Baseline|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
308967|NCT00213135|B2|Baseline|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
308968|NCT00213135|B1|Baseline|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
308969|NCT00213135|P3|Participant Flow|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
308970|NCT00213135|P2|Participant Flow|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
308971|NCT00213135|P1|Participant Flow|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
308972|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
308973|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
308975|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
308976|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
308977|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
308978|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
308979|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
308980|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
308981|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
308982|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
308983|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
308984|NCT00213135|E3|Reported Event|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
308985|NCT00213135|E2|Reported Event|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
308986|NCT00213135|E1|Reported Event|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
308987|NCT00214019|B1|Baseline|4 Way Cross Over|"Participants completed all 4 arms:
Placebo Salmeterol diskus 40 mcg twice per day Placebo then fluticasone Salmeterol then Fluticasone"
308988|NCT00214019|P1|Participant Flow|Placebo/Placebo|Placebo Diskus/Placebo Diskus 28 days
308989|NCT00214019|O4|Outcome|Salmeterol/Fluticasone|Participants on Salmeterol/Fluticasone
308990|NCT00214019|O3|Outcome|Placebo/fFuticasone|Participants on Placebo/Fluticasone arm
308991|NCT00214019|O2|Outcome|Placebo/Salmeterol|Participants on Placebo/Salmeterol arm
308995|NCT00214201|B2|Baseline|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
308996|NCT00214201|B1|Baseline|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
308997|NCT00214201|P2|Participant Flow|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
308998|NCT00214201|P1|Participant Flow|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
308999|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
309000|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
309001|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
309002|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of care CNI Immunosuppression
309003|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
309004|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
309005|NCT00214201|E2|Reported Event|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
309006|NCT00214201|E1|Reported Event|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
309007|NCT00214383|B3|Baseline|Total|Total of all reporting groups
309008|NCT00214383|B2|Baseline|Control|Control-usual care
309009|NCT00214383|B1|Baseline|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
309010|NCT00214383|P2|Participant Flow|Control|Control-usual care
309011|NCT00214383|P1|Participant Flow|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
309012|NCT00214383|O2|Outcome|Control|Control-usual care
309013|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
309014|NCT00214383|O2|Outcome|Control|Control-usual care
309015|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
309016|NCT00214383|O2|Outcome|Control|Control-usual care
309017|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
309018|NCT00214383|E2|Reported Event|Control|Control-usual care
309019|NCT00214383|E1|Reported Event|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
309020|NCT00214461|B5|Baseline|Total|Total of all reporting groups
309021|NCT00214461|B4|Baseline|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
309022|NCT00214461|B3|Baseline|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
309023|NCT00214461|B2|Baseline|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
309024|NCT00214461|B1|Baseline|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
309025|NCT00214461|P4|Participant Flow|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
309026|NCT00214461|P3|Participant Flow|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
309027|NCT00214461|P2|Participant Flow|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
309028|NCT00214461|P1|Participant Flow|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
309029|NCT00214461|O4|Outcome|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
309030|NCT00214461|O3|Outcome|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
309031|NCT00214461|O2|Outcome|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
309032|NCT00214461|O1|Outcome|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
309033|NCT00214461|O4|Outcome|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
309034|NCT00214461|O3|Outcome|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
309035|NCT00214461|O2|Outcome|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
309036|NCT00214461|O1|Outcome|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
309037|NCT00214461|E4|Reported Event|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
309038|NCT00214461|E3|Reported Event|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
309039|NCT00214461|E2|Reported Event|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
309040|NCT00214461|E1|Reported Event|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
309042|NCT00214487|B2|Baseline|Control|"Single vision soft contact lenses
Placebo Control: Single vision soft contact lenses"
309043|NCT00214487|B1|Baseline|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia
Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
309044|NCT00214487|P2|Participant Flow|Control|"Single vision soft contact lenses
Placebo Control: Single vision soft contact lenses"
309045|NCT00214487|P1|Participant Flow|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia
Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
309046|NCT00214487|O2|Outcome|Control|"Single vision soft contact lenses
Placebo Control: Single vision soft contact lenses"
309047|NCT00214487|O1|Outcome|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia
Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
309048|NCT00214487|E2|Reported Event|Control|"Single vision soft contact lenses
Placebo Control: Single vision soft contact lenses"
309049|NCT00214487|E1|Reported Event|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia
Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
309050|NCT00214526|B3|Baseline|Total|Total of all reporting groups
309051|NCT00214526|B2|Baseline|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309052|NCT00214526|B1|Baseline|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309053|NCT00214526|P2|Participant Flow|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
328530|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
309054|NCT00214526|P1|Participant Flow|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309055|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309056|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309057|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309058|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309059|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309060|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309061|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309062|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309063|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309064|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309065|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309066|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309067|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309068|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309069|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309070|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309071|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309072|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309073|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309074|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
309075|NCT00214526|E4|Reported Event|Control (Post-Treatment Period)|From 6 weeks after last Control visit through 1 year.
309076|NCT00214526|E3|Reported Event|Alair (Post-Treatment Period)|From 6 weeks after last Treatment visit through 1 year.
309077|NCT00214526|E2|Reported Event|Control (Treatment Period)|From first Control visit through 6 weeks after last Control visit.
309078|NCT00214526|E1|Reported Event|Alair (Treatment Period)|From first Treatment visit through 6 weeks after last Treatment visit.
309079|NCT00214539|B3|Baseline|Total|Total of all reporting groups
309080|NCT00214539|B2|Baseline|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
309081|NCT00214539|B1|Baseline|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
309082|NCT00214539|P2|Participant Flow|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
309132|NCT00214903|O4|Outcome|Non-oral HRT|Users of non-oral HRT preparations
309133|NCT00214903|O3|Outcome|ooHRT|Users of oral but not continuous combined HRT preparations
309083|NCT00214539|P1|Participant Flow|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
309084|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
309085|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
309086|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
309087|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
309088|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
309089|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
309090|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
309091|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
309092|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
309093|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
309094|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
309095|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
309096|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
309097|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
309098|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
309099|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
309100|NCT00214539|E6|Reported Event|Control (Steroid Wean and Reduced Steroid Phases)|
309101|NCT00214539|E5|Reported Event|Alair (Steroid Wean and Reduced Steroid Phases)|
309102|NCT00214539|E4|Reported Event|Control (Steroid Stable Phase)|
309103|NCT00214539|E3|Reported Event|Alair (Steroid Stable Phase)|
309104|NCT00214539|E2|Reported Event|Control (Treatment Period)|
309105|NCT00214539|E1|Reported Event|Alair (Treatment Period)|
309106|NCT00214786|B1|Baseline|Islet Cell|Patients with allogeneic islet cell transplantation
309107|NCT00214786|P1|Participant Flow|Islet Cell Transplantation|Patients who received islet cell transplantation. The recipients will be given islet cell preparation with more than 4000 Islet Equivalent (IE)/kg for multiple times up to 3 infusions.
309108|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
309110|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
309111|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
309112|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
309113|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
309114|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
309115|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
309116|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
309117|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
309118|NCT00214786|E1|Reported Event|Islet Cell|Patients with allogeneic islet cell transplantation
309119|NCT00214903|B5|Baseline|Total|Total of all reporting groups
309120|NCT00214903|B4|Baseline|Non-oral HRT|Users of non-oral HRT preparations
309121|NCT00214903|B3|Baseline|ooHRT|Users of oral but not continuous combined HRT preparations
309122|NCT00214903|B2|Baseline|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
309123|NCT00214903|B1|Baseline|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
309124|NCT00214903|P4|Participant Flow|Non-oral HRT|Users of non-oral HRT preparations
309125|NCT00214903|P3|Participant Flow|ooHRT|Users of oral but not continuous combined HRT preparations
309126|NCT00214903|P2|Participant Flow|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
309127|NCT00214903|P1|Participant Flow|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
309128|NCT00214903|O4|Outcome|Non-oral HRT|Users of non-oral HRT preparations
309129|NCT00214903|O3|Outcome|ooHRT|Users of oral but not continuous combined HRT preparations
309130|NCT00214903|O2|Outcome|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
309131|NCT00214903|O1|Outcome|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
309134|NCT00214903|O2|Outcome|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
309135|NCT00214903|O1|Outcome|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
309136|NCT00214903|E4|Reported Event|Non-oral HRT|Users of non-oral HRT preparations
309137|NCT00214903|E3|Reported Event|ooHRT|Users of oral but not continuous combined HRT preparations
309138|NCT00214903|E2|Reported Event|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
309139|NCT00214903|E1|Reported Event|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
309140|NCT00205374|B3|Baseline|Total|Total of all reporting groups
309141|NCT00205374|B2|Baseline|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
309142|NCT00205374|B1|Baseline|Cidofovir|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
309143|NCT00205374|P2|Participant Flow|Placebo|The placebo treatment was injection of saline solution that had a color and viscosity identical to those of the active drug. Up to 6 injections per participant were given during the study.
309144|NCT00205374|P1|Participant Flow|Cidofovir|With regard to cidofovir concentration, the FDA has allowed us to inject a concentration of 5 mg/ml into both children and adults. The injection will add less than 2 additional minutes to the surgery time and discharge time will not be affected. Because the volumes of cidofovir injected into the airway will be reasonably small (typically less than 2 mL), the total systemic dose of cidofovir administered per visit will be far below the FDA-approved systemic limit of 5 mg/kg for HIV-related CMV retinitis. No more than 6 treatments were performed per patient within the 12-month time interval of the study.
309145|NCT00205374|O2|Outcome|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
309146|NCT00205374|O1|Outcome|Cidofovir|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
309147|NCT00205374|O2|Outcome|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
309148|NCT00205374|O1|Outcome|Cidofovir|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
309149|NCT00205374|E2|Reported Event|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
309150|NCT00205374|E1|Reported Event|Cidofovir|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
309151|NCT00205504|B3|Baseline|Total|Total of all reporting groups
309152|NCT00205504|B2|Baseline|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
309153|NCT00205504|B1|Baseline|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².
Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
309154|NCT00205504|P2|Participant Flow|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
309407|NCT00205803|B3|Baseline|Total|Total of all reporting groups
309155|NCT00205504|P1|Participant Flow|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².
Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
309156|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
309157|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
309158|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
309159|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
309160|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
309161|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
309162|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
309163|NCT00205504|O1|Outcome|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².
Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
309164|NCT00205504|O2|Outcome|Lean Women|Women with BMI >25 kg/m²
309165|NCT00205504|O1|Outcome|Obese Women|Women with BMI >30 kg/m²
309166|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
309167|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
309168|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
309169|NCT00205504|O1|Outcome|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².
Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
309170|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
309171|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
309174|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
309175|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
309176|NCT00205504|E2|Reported Event|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
309177|NCT00205504|E1|Reported Event|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².
Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
309178|NCT00205712|B3|Baseline|Total|Total of all reporting groups
309179|NCT00205712|B2|Baseline|Ketamine Plus Dexmedetomidine|ketamine infusion plus dexmedetomidine
309180|NCT00205712|B1|Baseline|Ketamine Alone|ketamine without dexmedetomidine
309181|NCT00205712|P2|Participant Flow|Ketamine Plus Dexmedetomidine|Ketamine infusion plus dexmedetomidine
309182|NCT00205712|P1|Participant Flow|Ketamine Alone|Ketamine without dexmedetomidine
309183|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
309184|NCT00205712|O1|Outcome|Ketamine Alone|Ketamine without dexmedetomidine
309185|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
309186|NCT00205712|O1|Outcome|Ketamine Alone|Ketamine without dexmedetomidine
309187|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|ketamine infusion plus dexmedetomidine
309188|NCT00205712|O1|Outcome|Ketamine Alone|ketamine without dexmedetomidine
309189|NCT00205712|E2|Reported Event|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
309190|NCT00205712|E1|Reported Event|Ketamine Alone|Ketamine without dexmedetomidine
309191|NCT00205777|B5|Baseline|Total|Total of all reporting groups
309192|NCT00205777|B4|Baseline|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309193|NCT00205777|B3|Baseline|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309194|NCT00205777|B2|Baseline|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309195|NCT00205777|B1|Baseline|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309196|NCT00205777|P6|Participant Flow|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309197|NCT00205777|P5|Participant Flow|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309198|NCT00205777|P4|Participant Flow|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309199|NCT00205777|P3|Participant Flow|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309504|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309200|NCT00205777|P2|Participant Flow|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309201|NCT00205777|P1|Participant Flow|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 milligram (mg) capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309202|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309203|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309204|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309205|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309206|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309207|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309208|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
328531|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
309209|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309210|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309211|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309212|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309213|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309214|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309215|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309216|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309217|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309218|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309219|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309220|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309221|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309222|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309223|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309224|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309225|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309226|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309227|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309228|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309229|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309230|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309231|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309232|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309233|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309861|NCT00208767|O2|Outcome|Placebo|Patients received a placebo instead of Valsartan
309234|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309235|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309236|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309237|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309238|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309239|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309240|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309241|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309242|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309243|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309244|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309245|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309246|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309247|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309505|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
315863|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
309248|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309249|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309250|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309251|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309252|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309253|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309254|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309255|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309302|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309256|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309257|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309258|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309259|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309260|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309261|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309262|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309263|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309264|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309265|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309266|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309267|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309268|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309269|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309270|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309271|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309272|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309273|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309274|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309275|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309276|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309277|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309278|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309279|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309280|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309281|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309282|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309283|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309284|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309285|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309286|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309287|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309288|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309289|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309290|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309291|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309292|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309293|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309294|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309295|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309296|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309297|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309298|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309299|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309300|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309301|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309469|NCT00205881|O1|Outcome|Baseline|Testing with hearing aids in best-aided condition.
309303|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309304|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309305|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309306|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309307|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309308|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309309|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309310|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309311|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309312|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309313|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309314|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309315|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309316|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309317|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309318|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309319|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309320|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309321|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309322|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309323|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309324|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309325|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309326|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309327|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309328|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309329|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309330|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309331|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309332|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309333|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309334|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309335|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309336|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309337|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309338|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309339|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309581|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
309340|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309341|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309342|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309343|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309344|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309345|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309346|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309347|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309348|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
328532|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
309349|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309350|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309351|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309352|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309353|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309354|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309355|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309356|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309357|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309358|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309359|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309360|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309361|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309362|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309363|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309364|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309365|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309366|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309367|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309368|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309369|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309370|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
310032|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
309371|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309372|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309373|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309374|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309375|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309376|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309377|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309378|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309379|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309380|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309381|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309382|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309383|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309455|NCT00205803|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
315864|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
309384|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309385|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309386|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309387|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309388|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309389|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309390|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309391|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309392|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309393|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
328533|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
309394|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309395|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309396|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309397|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309398|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309399|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309400|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309401|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309402|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
309403|NCT00205777|E4|Reported Event|Placebo|Matching placebo capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in the core study, study extension I and II.
309404|NCT00205777|E3|Reported Event|Raloxifene 60 mg (Core Study)|Raloxifene 60 mg capsule orally once daily in the core study along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309405|NCT00205777|E2|Reported Event|Bazedoxifene 40/ 20 mg|Bazedoxifene acetate 40 mg capsule orally once daily in the core study, in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, and II along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
309406|NCT00205777|E1|Reported Event|Bazedoxifene 20 mg|Bazedoxifene acetate 20 mg capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in core study, study extension I and II.
309408|NCT00205803|B2|Baseline|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309409|NCT00205803|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309410|NCT00205803|P2|Participant Flow|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309411|NCT00205803|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309412|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309413|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309414|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309415|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309416|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309417|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309418|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309419|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309420|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309421|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309422|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
309423|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series).
309424|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309425|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309426|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309427|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309428|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309429|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309430|NCT00205803|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309431|NCT00205803|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309432|NCT00205803|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
309433|NCT00205803|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
309434|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309435|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309436|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309437|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309438|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309439|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309440|NCT00205803|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
309441|NCT00205803|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
309442|NCT00205803|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
309443|NCT00205803|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
309444|NCT00205803|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
309445|NCT00205803|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
309446|NCT00205803|O2|Outcome|7vPnc Dose 1|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
309447|NCT00205803|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
309448|NCT00205803|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
309449|NCT00205803|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
309450|NCT00205803|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
309451|NCT00205803|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
309452|NCT00205803|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
309453|NCT00205803|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
309454|NCT00205803|O2|Outcome|7vPnc Dose 1|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
315865|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
309456|NCT00205803|E6|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309457|NCT00205803|E5|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
309458|NCT00205803|E4|Reported Event|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
309459|NCT00205803|E3|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
309460|NCT00205803|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
309461|NCT00205803|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
309462|NCT00205855|B1|Baseline|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
309463|NCT00205855|P1|Participant Flow|Spinal Cord Stimulation (SCS) Group|"Upon meeting entry criteria and a baselineline evaluation all eligible subjects then receive either a temporary lead or a permanent lead (both leads are considered trial durign this phase) attached to an external stimulator for a minimum period of 48 hours. Patients who are determined to have 50% improvement in the VAS score from baseline after the trial phase were implanted with the Precision Spinal Cord Stimulation System."
309464|NCT00205855|O1|Outcome|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
309465|NCT00205855|E1|Reported Event|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
309466|NCT00205881|B1|Baseline|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
309467|NCT00205881|P1|Participant Flow|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
309468|NCT00205881|O2|Outcome|8 Months Post-device Activation|Testing conducted with bilateral implants.
309470|NCT00205881|E1|Reported Event|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
309471|NCT00206076|B3|Baseline|Total|Total of all reporting groups
309472|NCT00206076|B2|Baseline|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
309473|NCT00206076|B1|Baseline|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
309474|NCT00206076|P2|Participant Flow|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
309475|NCT00206076|P1|Participant Flow|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
309476|NCT00206076|O2|Outcome|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
309477|NCT00206076|O1|Outcome|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
309478|NCT00206076|O2|Outcome|CNI Reduction|calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment
309479|NCT00206076|O1|Outcome|CNI Discontinued|complete withdrawal of calcineurin inhibitors (CNI)
309480|NCT00206076|O2|Outcome|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
309481|NCT00206076|O1|Outcome|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
309482|NCT00206076|E2|Reported Event|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
309483|NCT00206076|E1|Reported Event|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
309484|NCT00206102|B3|Baseline|Total|Total of all reporting groups
309485|NCT00206102|B2|Baseline|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309486|NCT00206102|B1|Baseline|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309487|NCT00206102|P2|Participant Flow|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309488|NCT00206102|P1|Participant Flow|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309489|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309490|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309491|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309492|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309493|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309494|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309495|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309496|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309497|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309498|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309499|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309500|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309501|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309502|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309503|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309506|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309507|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309508|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309509|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309510|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309511|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309512|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309513|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309514|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309515|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309516|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309517|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309518|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309519|NCT00206102|E2|Reported Event|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
309520|NCT00206102|E1|Reported Event|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
309521|NCT00207090|B1|Baseline|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
328534|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
309522|NCT00207090|P1|Participant Flow|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309523|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309524|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2.
309525|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309526|NCT00207090|O1|Outcome|Ixabepilone + Rifampin|Each participant was administered an oral dose of 600 mg of rifampin while in a fasted state on Day 22 (Cycle 2). Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2.
309527|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309582|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
309583|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
309584|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
309585|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
309528|NCT00207090|O1|Outcome|All Participants|All participants who were enrolled into the study, 24 hours before ixabepilone administration on Day -1. Each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2 on Day 1 of Cycle 1. Each participant was administered an oral dose of 600 mg of rifampin while in a fasted state on Day 22 (Cycle 2). Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23 through 28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food during Cycle 2.
309529|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309530|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
309531|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309560|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309561|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
309562|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
309532|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309533|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
309534|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309535|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
309536|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309537|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
309586|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
309587|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
309588|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
309589|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
309590|NCT00207142|E3|Reported Event|Non-Randomized Participants|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
309591|NCT00207142|E2|Reported Event|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
309538|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309539|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
309540|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309541|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
309542|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309563|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309564|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309654|NCT00207740|B3|Baseline|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
309543|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309544|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309545|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309546|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
309592|NCT00207142|E1|Reported Event|Switch Regimen|ATV 400 mg QD + 2 NRTIs
309593|NCT00207714|B6|Baseline|Total|Total of all reporting groups
309610|NCT00207714|O6|Outcome|Combined: Groups II, III, IV & V|Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 Wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 Wks).
309547|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309548|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
309549|NCT00207090|E1|Reported Event|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
309550|NCT00207142|B4|Baseline|Total|Total of all reporting groups
309551|NCT00207142|B3|Baseline|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase: ATV 300 mg + RTV 100 mg QD + 2 NRTIs
309552|NCT00207142|B2|Baseline|Randomized Subjects: Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
309553|NCT00207142|B1|Baseline|Randomized Subjects: Switch Regimen|ATV 400 mg QD + 2 NRTIs
309554|NCT00207142|P4|Participant Flow|Rescue Treatment|Participants without confirmed undetectable viral load at the end of Induction Phase were not randomized, but were offered to continue on ATV 300 mg + RTV 100 mg QD + 2 NRTIs for an additional 48 weeks (continued previous NRTI).
309555|NCT00207142|P3|Participant Flow|Maintenance Treatment: Continuation Regimen|Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase) at the end of Induction Phase, who were then randomized to ATV 300 mg + RTV 100 mg QD for an additional 48 weeks (continued previous NRTI).
309556|NCT00207142|P2|Participant Flow|Maintenance Treatment: Switch Regimen|Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase), at the end of Induction Phase, who were then randomized to ATV 400 mg QD for an additional 48 weeks (continued previous NRTI).
309557|NCT00207142|P1|Participant Flow|Induction Treatment|Atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg, given once daily (QD) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) during a 26- to 30-week Induction Phase
309558|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300mg + RTV 100mg QD + 2NRTIs
309559|NCT00207142|O1|Outcome|Switch Regimen|ATV 400mg QD + 2NRTIs
309703|NCT00207883|P2|Participant Flow|Group 2 - Ultra Sound US|ultra sound assisted CVC placement
309565|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309566|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
309567|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400mg QD + 2NRTIs) or Continuation Regimen (ATV 300mg + RTV 100mg QD + 2NRTIs)
309568|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
309569|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400mg QD + 2NRTIs) or Continuation Regimen (ATV 300mg + RTV 100mg QD + 2NRTIs)
309570|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309571|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309572|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309573|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309574|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309575|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309576|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309577|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309578|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309579|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
309580|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
309594|NCT00207714|B5|Baseline|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
309595|NCT00207714|B4|Baseline|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
309596|NCT00207714|B3|Baseline|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
309597|NCT00207714|B2|Baseline|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
309598|NCT00207714|B1|Baseline|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
309599|NCT00207714|P5|Participant Flow|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
310033|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
309600|NCT00207714|P4|Participant Flow|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
309601|NCT00207714|P3|Participant Flow|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
309602|NCT00207714|P2|Participant Flow|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
309603|NCT00207714|P1|Participant Flow|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
309604|NCT00207714|O6|Outcome|Combined: Groups II, III, IV & V|Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 wks).
309605|NCT00207714|O5|Outcome|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
309606|NCT00207714|O4|Outcome|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 wks thru Wk 18 plus MTX (Weeks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Weeks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
309607|NCT00207714|O3|Outcome|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
309608|NCT00207714|O2|Outcome|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 mg SC injections every 4 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
309609|NCT00207714|O1|Outcome|Group I: Placebo Crossover to Infliximab|Placebo SC injections every 2 wks from Wk 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 wks thru Wk 44. Continue stable dose of MTX throughout the study.
309634|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
309611|NCT00207714|O5|Outcome|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
309612|NCT00207714|O4|Outcome|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
309613|NCT00207714|O3|Outcome|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
309614|NCT00207714|O2|Outcome|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 mg SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
309615|NCT00207714|O1|Outcome|Group I: Placebo Crossover to Infliximab|Placebo SC injections every 2 weeks (Wks) from week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
309616|NCT00207714|E5|Reported Event|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 milligrams (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
309651|NCT00207727|E1|Reported Event|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
309652|NCT00207740|B5|Baseline|Total|Total of all reporting groups
309653|NCT00207740|B4|Baseline|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
309617|NCT00207714|E4|Reported Event|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg subcutaneous (SC) injections every 4 weeks (Wks) thru Week (Wk) 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
309618|NCT00207714|E3|Reported Event|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 miligram (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
309619|NCT00207714|E2|Reported Event|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) subcutaneous (SC) injections every 4 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
309620|NCT00207714|E1|Reported Event|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
309621|NCT00207727|B6|Baseline|Total|Total of all reporting groups
309622|NCT00207727|B5|Baseline|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309623|NCT00207727|B4|Baseline|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309624|NCT00207727|B3|Baseline|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
309625|NCT00207727|B2|Baseline|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309626|NCT00207727|B1|Baseline|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
309627|NCT00207727|P5|Participant Flow|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309628|NCT00207727|P4|Participant Flow|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309629|NCT00207727|P3|Participant Flow|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
309630|NCT00207727|P2|Participant Flow|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309631|NCT00207727|P1|Participant Flow|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
309632|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309633|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
310050|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
309635|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309636|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
309637|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309638|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309639|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
309640|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309641|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
309642|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309643|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309644|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
309645|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309646|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
309647|NCT00207727|E5|Reported Event|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309648|NCT00207727|E4|Reported Event|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
309649|NCT00207727|E3|Reported Event|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
309650|NCT00207727|E2|Reported Event|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
310447|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
309655|NCT00207740|B2|Baseline|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
309656|NCT00207740|B1|Baseline|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
309657|NCT00207740|P4|Participant Flow|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
309658|NCT00207740|P3|Participant Flow|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
309659|NCT00207740|P2|Participant Flow|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
309660|NCT00207740|P1|Participant Flow|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
309661|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
309662|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
309663|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
309664|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
309665|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
309666|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
309667|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
309668|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
309669|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
309670|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from Wk 0 to Wk 52
309671|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
309672|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
309673|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
309674|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
309675|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from Wk 0 to Wk 52
309676|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
309677|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
309678|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
309679|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
309680|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
309681|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
309682|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
310152|NCT00217490|B2|Baseline|Counseling Only|Dietary counseling delivered by nutritionist
309683|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
309684|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
309685|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
309686|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
309687|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
309688|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
309689|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
309690|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
309691|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
309692|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
309693|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
309694|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
309695|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
309696|NCT00207740|E4|Reported Event|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 wks to Wk 52
309697|NCT00207740|E3|Reported Event|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 wks to Wk 52
309698|NCT00207740|E2|Reported Event|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 wks to Wk 52
309699|NCT00207740|E1|Reported Event|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 wks from Wk 0 to Wk 52
309700|NCT00207883|B3|Baseline|Total|Total of all reporting groups
309701|NCT00207883|B2|Baseline|Group 2 - US|ultra sound assisted CVC placement
309702|NCT00207883|B1|Baseline|Group 1 - LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
309704|NCT00207883|P1|Participant Flow|Group 1 - Traditional Anatomic Landmark- LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
309705|NCT00207883|O2|Outcome|Group 2 - US|ultra sound assisted CVC placement
309706|NCT00207883|O1|Outcome|Group 1 - LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
309707|NCT00207883|O2|Outcome|Group 2 - US|ultra sound assisted CVC placement
309708|NCT00207883|O1|Outcome|Group 1 - LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
309709|NCT00207883|E2|Reported Event|Group 2 - US|ultra sound assisted central line placement 10/118 (8.5%) had arterial puncture. None was considered serious.
309710|NCT00207883|E1|Reported Event|Group 1 - LM|"traditional anatomic landmark central line placement utilizing palpation and the Seldinger technique.
18/93 (19.4%) had arterial puncture. None was considered serious."
309711|NCT00208026|B1|Baseline|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
309712|NCT00208026|P1|Participant Flow|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
309713|NCT00208026|O1|Outcome|Pimecrolimus 1% Cream|"Treatment with drug/Elidel. Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
Pimecrolimus 1% Cream: Open label single arm"
309714|NCT00208026|E1|Reported Event|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
309715|NCT00208091|B1|Baseline|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
309716|NCT00208091|P1|Participant Flow|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
309717|NCT00208091|O1|Outcome|Post-injection Subjective Change|Subjective assessment 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
309718|NCT00208091|O2|Outcome|Note Errors, Post-injection|Note errors (related to errors in loudness) 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
309719|NCT00208091|O1|Outcome|Note Errors, Baseline|Note errors (related to errors in loudness) were calculated as a measure of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note loudness.
309720|NCT00208091|O2|Outcome|Note Errors (Related to Errors in Duration), Post-injection|Note errors 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
310051|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
309721|NCT00208091|O1|Outcome|Note Errors (Related to Errors in Duration), Baseline|Note errors (related to errors in duration) were calculated as measures of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes played. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note duration.
309722|NCT00208091|E1|Reported Event|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
309723|NCT00208325|B5|Baseline|Total|Total of all reporting groups
309724|NCT00208325|B4|Baseline|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309725|NCT00208325|B3|Baseline|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309726|NCT00208325|B2|Baseline|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309727|NCT00208325|B1|Baseline|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309728|NCT00208325|P4|Participant Flow|PFC Mobile Bearing PCL Retained|"Mobile bearing
P.F.C Sigma Mobile Bearing Total knee system: Orthopaedic implant for total knee replacement"
309729|NCT00208325|P3|Participant Flow|PFC Fixed Bearing PCL Retained|"Fixed bearing
P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement"
309730|NCT00208325|P2|Participant Flow|PFC Mobile Bearing PCL Sacrificed|"Mobile bearing
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309731|NCT00208325|P1|Participant Flow|PFC Fixed Bearing PCL Sacrificed|"Fixed bearing
P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement"
309732|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309733|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309734|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309735|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309736|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309737|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309738|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309739|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309740|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309741|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309742|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309743|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309744|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309745|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309746|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309747|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309748|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309749|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309750|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309751|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309752|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
310052|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
309753|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309754|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309755|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309756|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309757|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309758|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309759|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309760|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309761|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309762|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309763|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309764|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309765|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309766|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309858|NCT00208767|B1|Baseline|Valsartan|"Valsartan titrated up to 320 mg orally daily
Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
309767|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309768|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309769|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309770|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309771|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309772|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309773|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309774|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309775|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309776|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309777|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309778|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309779|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309780|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309781|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309782|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309783|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309784|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309785|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309786|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309787|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309788|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309789|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309790|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309791|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309792|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309793|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309794|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309795|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309796|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309797|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309798|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309859|NCT00208767|P2|Participant Flow|Placebo|Patients received a placebo instead of Valsartan
310448|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
309799|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309800|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309801|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309802|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309803|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309804|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309805|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309806|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309807|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309808|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309809|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309810|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309811|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309812|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309813|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309814|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309815|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309816|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309817|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309818|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309819|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309820|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309821|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309822|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309823|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309824|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309825|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309826|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309827|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309828|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309829|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309830|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309860|NCT00208767|P1|Participant Flow|Valsartan|"Valsartan titrated up to 320 mg orally daily
Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
309831|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309832|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309833|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309834|NCT00208325|E4|Reported Event|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309835|NCT00208325|E3|Reported Event|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309836|NCT00208325|E2|Reported Event|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
309837|NCT00208325|E1|Reported Event|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
309838|NCT00208494|B3|Baseline|Total|Total of all reporting groups
309839|NCT00208494|B2|Baseline|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
309840|NCT00208494|B1|Baseline|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
309841|NCT00208494|P2|Participant Flow|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
309842|NCT00208494|P1|Participant Flow|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
309843|NCT00208494|O2|Outcome|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
309844|NCT00208494|O1|Outcome|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
309845|NCT00208494|E2|Reported Event|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
309846|NCT00208494|E1|Reported Event|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
309847|NCT00208507|B3|Baseline|Total|Total of all reporting groups
309848|NCT00208507|B2|Baseline|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
310053|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
309849|NCT00208507|B1|Baseline|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
309850|NCT00208507|P2|Participant Flow|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
309851|NCT00208507|P1|Participant Flow|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
309852|NCT00208507|O2|Outcome|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
309853|NCT00208507|O1|Outcome|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
309854|NCT00208507|E2|Reported Event|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
309855|NCT00208507|E1|Reported Event|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
309856|NCT00208767|B3|Baseline|Total|Total of all reporting groups
309857|NCT00208767|B2|Baseline|Placebo|Patients received a placebo instead of Valsartan
309862|NCT00208767|O1|Outcome|Valsartan|"Valsartan titrated up to 320 mg orally daily
Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
309863|NCT00208767|E2|Reported Event|Placebo|Patients received a placebo instead of Valsartan
309864|NCT00208767|E1|Reported Event|Valsartan|"Valsartan titrated up to 320 mg orally daily
Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
309865|NCT00208949|B3|Baseline|Total|Total of all reporting groups
309866|NCT00208949|B2|Baseline|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
309867|NCT00208949|B1|Baseline|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
309868|NCT00208949|P2|Participant Flow|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
309869|NCT00208949|P1|Participant Flow|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
309870|NCT00208949|O2|Outcome|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
309871|NCT00208949|O1|Outcome|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day
309872|NCT00208949|O2|Outcome|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
309873|NCT00208949|O1|Outcome|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day
309874|NCT00208949|E2|Reported Event|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
309875|NCT00208949|E1|Reported Event|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
309876|NCT00208975|B1|Baseline|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
309877|NCT00208975|P1|Participant Flow|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
309878|NCT00208975|O2|Outcome|Non Hodgkin Lymphoma|"Non-Hodgkin's lymphoma, also called non-Hodgkin lymphoma, is cancer that originates in your lymphatic system, the disease-fighting network spread throughout your body. In non-Hodgkin's lymphoma, tumors develop from lymphocytes — a type of white blood cell.
Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab."
309879|NCT00208975|O1|Outcome|Chronic Lymphocytic Leukemia|"Chronic Lymphocytic Leukemia (CLL) is a condition characterized by an accumulation of abnormal lymphocytes in the blood and the bone marrow. These lymphocytes do not perform their functions as normal ones would and interfere with the production of other blood cells necessary for the normal functioning of the blood, leading to a host of complications like deficiency of the immune system, coagulation problems, swollen lymph nodes, and many other conditions.
Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab."
310054|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
309880|NCT00208975|E1|Reported Event|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
309881|NCT00209027|B3|Baseline|Total|Total of all reporting groups
309882|NCT00209027|B2|Baseline|Controls|Baseline fMRI scan
309883|NCT00209027|B1|Baseline|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
309884|NCT00209027|P2|Participant Flow|Controls|Baseline fMRI scan
309885|NCT00209027|P1|Participant Flow|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
309886|NCT00209027|O2|Outcome|Controls|Healthy males without a psychiatric diagnosis
309887|NCT00209027|O1|Outcome|Schizophrenia Subjects|Males patients with schizophrenia
309888|NCT00209027|E2|Reported Event|Controls|Baseline fMRI scan
309889|NCT00209027|E1|Reported Event|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
309890|NCT00209092|B3|Baseline|Total|Total of all reporting groups
309891|NCT00209092|B2|Baseline|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
309892|NCT00209092|B1|Baseline|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
309893|NCT00209092|P2|Participant Flow|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
309894|NCT00209092|P1|Participant Flow|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
309895|NCT00209092|O2|Outcome|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
309896|NCT00209092|O1|Outcome|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
309897|NCT00209092|O2|Outcome|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
309898|NCT00209092|O1|Outcome|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
309995|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
309899|NCT00209092|E2|Reported Event|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
309900|NCT00209092|E1|Reported Event|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
309901|NCT00209131|B3|Baseline|Total|Total of all reporting groups
309902|NCT00209131|B2|Baseline|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
309903|NCT00209131|B1|Baseline|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
309904|NCT00209131|P2|Participant Flow|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
309905|NCT00209131|P1|Participant Flow|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
309906|NCT00209131|O2|Outcome|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
309907|NCT00209131|O1|Outcome|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
309908|NCT00209131|O2|Outcome|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
309909|NCT00209131|O1|Outcome|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
309910|NCT00209131|E2|Reported Event|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
309911|NCT00209131|E1|Reported Event|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
309912|NCT00209170|B3|Baseline|Total|Total of all reporting groups
309913|NCT00209170|B2|Baseline|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
309914|NCT00209170|B1|Baseline|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
309915|NCT00209170|P2|Participant Flow|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
309916|NCT00209170|P1|Participant Flow|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
310055|NCT00216476|O1|Outcome|Aripiprazole|oral, recommended maintenance dose of 10-30 mg q.d.
309917|NCT00209170|O2|Outcome|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
309918|NCT00209170|O1|Outcome|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
309919|NCT00209170|E2|Reported Event|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
309920|NCT00209170|E1|Reported Event|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
309921|NCT00215137|B1|Baseline|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
309922|NCT00215137|P3|Participant Flow|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
309923|NCT00215137|P2|Participant Flow|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
309924|NCT00215137|P1|Participant Flow|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
309925|NCT00215137|O3|Outcome|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from beginning of the study phase sample.
309926|NCT00215137|O2|Outcome|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post beginning of the study phase sample.
309927|NCT00215137|O1|Outcome|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post baseline sample.
309996|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
309928|NCT00215137|E3|Reported Event|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
309929|NCT00215137|E2|Reported Event|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
309930|NCT00215137|E1|Reported Event|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
309931|NCT00215150|B1|Baseline|Study Treatment|8 weeks of open label treatment with sertraline followed by 8 weeks of treatment with ziprasidone/placebo for qualifying subjects
309932|NCT00215150|P1|Participant Flow|Open Label Treatment|8 weeks of open label treatment with sertraline (50-200mg/day)followed by 8 weeks of randomized, Double Blind (DB), placebo-controlled augmentation with ziprasidone (40-160mg/day)for qualifying subjects.
309933|NCT00215150|O3|Outcome|Randomization Phase for Placebo Group|The group of subjects randomized to receive placebo for the second 8 weeks
309934|NCT00215150|O2|Outcome|Randomization Phase for Ziprasidone Group|The group of subjects randomized to receive Ziprasidone for the second 8 weeks
309935|NCT00215150|O1|Outcome|Open Label Phase|The open label treatment phase for the first 8 weeks
309936|NCT00215150|E3|Reported Event|Randomization Phase for Placebo|The second phase of treatment with subjects randomized to placebo augmentation.
309937|NCT00215150|E2|Reported Event|Randomization Phase for Ziprasidone|The second phase of treatment with subjects randomized to ziprasidone augmentation.
309938|NCT00215150|E1|Reported Event|Open Label Phase|The first 8 weeks of treatment on sertraline
309939|NCT00215930|B1|Baseline|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
309940|NCT00215930|P1|Participant Flow|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression of Ribonucleotide reductase subunit 1(ERCC1) and Excision repair cross-complementing group 1 gene (RRM1). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days. DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days. DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days. GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.
309941|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
309942|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
310056|NCT00216476|O2|Outcome|Quetiapine|oral, target dose of 300-400 mg b.i.d. or t.i.d.
309943|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression. Complete Response (CR): disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive Disease (PD): at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started.
309944|NCT00215930|E1|Reported Event|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
309945|NCT00215943|B3|Baseline|Total|Total of all reporting groups
309946|NCT00215943|B2|Baseline|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
309947|NCT00215943|B1|Baseline|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
309948|NCT00215943|P2|Participant Flow|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
309949|NCT00215943|P1|Participant Flow|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
309950|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
309951|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
309997|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
310522|NCT00223678|E1|Reported Event|Rapamycin Group|
309952|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
309953|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
309954|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
309955|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
309956|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
309957|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
309958|NCT00215943|E2|Reported Event|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
310057|NCT00216476|O1|Outcome|Risperidone LAI|intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
310058|NCT00216476|E3|Reported Event|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
310153|NCT00217490|B1|Baseline|Computer Only|Dietary Counseling delivered by interactive computer
309959|NCT00215943|E1|Reported Event|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
309960|NCT00216060|B3|Baseline|Total|Total of all reporting groups
309961|NCT00216060|B2|Baseline|Placebo|daily oral placebo combined with androgen deprivation
309962|NCT00216060|B1|Baseline|Risedronate|Daily oral risedronate combined with androgen deprivation
309963|NCT00216060|P2|Participant Flow|Placebo|daily oral placebo combined with androgen deprivation
309964|NCT00216060|P1|Participant Flow|Risedronate|Daily oral risedronate combined with androgen deprivation
309965|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation"
309966|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation"
309967|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation"
309968|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation"
309969|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation"
309970|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation"
309971|NCT00216060|O2|Outcome|Placebo|daily oral placebo combined with androgen deprivation
309972|NCT00216060|O1|Outcome|Risedronate|Daily oral risedronate combined with androgen deprivation
309973|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation"
309974|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation"
309975|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation"
309976|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation"
309977|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation"
309978|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation"
309979|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation"
309980|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation"
309981|NCT00216060|E2|Reported Event|Risedronate|Daily oral risedronate combined with androgen deprivation
309982|NCT00216060|E1|Reported Event|Placebo|daily oral placebo combined with androgen deprivation
309998|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
309983|NCT00216086|B1|Baseline|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
309984|NCT00216086|P1|Participant Flow|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
309985|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
310059|NCT00216476|E2|Reported Event|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
310060|NCT00216476|E1|Reported Event|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
309986|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
309987|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
309988|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
309989|NCT00216086|E1|Reported Event|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
309990|NCT00216099|B1|Baseline|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
309991|NCT00216099|P1|Participant Flow|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
309992|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
309993|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
309994|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
309999|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
310000|NCT00216099|E1|Reported Event|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
310001|NCT00216125|B1|Baseline|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.
Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36
Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33
Radiation: Radiation 5940 cGy (180 cGy/day)"
310002|NCT00216125|P3|Participant Flow|Observation Only|Patients were followed for Observation.
310003|NCT00216125|P2|Participant Flow|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.
Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
310004|NCT00216125|P1|Participant Flow|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.
Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36
Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33
Radiation: Radiation 5940 cGy (180 cGy/day)"
310005|NCT00216125|O2|Outcome|Observation Only|Patients were followed for Observation.
310006|NCT00216125|O1|Outcome|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.
Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
310007|NCT00216125|O2|Outcome|Observation Only|Patients were followed for Observation.
310008|NCT00216125|O1|Outcome|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.
Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
310009|NCT00216125|E3|Reported Event|Observation Only|Patients were followed for Observation.
310010|NCT00216125|E2|Reported Event|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.
Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
310061|NCT00216671|B3|Baseline|Total|Total of all reporting groups
310148|NCT00217464|E1|Reported Event|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.
fulvestrant: intramuscularly"
310149|NCT00217490|B5|Baseline|Total|Total of all reporting groups
310011|NCT00216125|E1|Reported Event|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.
Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36
Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33
Radiation: Radiation 5940 cGy (180 cGy/day)
Adverse events reported in this arm consist only of participants that were not randomized into the Consolidation Docetaxel or Observation Only arms."
310012|NCT00216203|B1|Baseline|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
310013|NCT00216203|P1|Participant Flow|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
310014|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
310015|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
310016|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
310017|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
310018|NCT00216203|O1|Outcome|Investigational Treatment|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
310019|NCT00216203|E1|Reported Event|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
310020|NCT00216320|B4|Baseline|Total|Total of all reporting groups
310021|NCT00216320|B3|Baseline|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
310022|NCT00216320|B2|Baseline|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
310023|NCT00216320|B1|Baseline|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
310024|NCT00216320|P3|Participant Flow|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
310025|NCT00216320|P2|Participant Flow|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
310026|NCT00216320|P1|Participant Flow|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
310027|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
310028|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
310029|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
310030|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
310031|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
310523|NCT00223704|B4|Baseline|Total|Total of all reporting groups
310034|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
310035|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
310036|NCT00216320|O1|Outcome|Subjects Who Used Both WA and AFO|Subjects in arm 1 (wore WalkAide for 6 weeks followed by AFO for 6 weeks) and arm 2 (wore AFO for 6 weeks followed by WalkAide for 6 weeks)were given the option of continuing for 12 more weeks with their choice of device
310037|NCT00216320|E3|Reported Event|Arm 3|All subjects used AFO for all 12 weeks of study.
310038|NCT00216320|E2|Reported Event|Arm 2|All subjects used AFO for the first 6 weeks and WalkAide for the second six weeks.
310039|NCT00216320|E1|Reported Event|Arm 1|All subjects used WalkAide for the first 6 weeks and AFO for the second six weeks.
310040|NCT00216476|B3|Baseline|Total|Total of all reporting groups
310041|NCT00216476|B2|Baseline|Quetiapine|oral, target dose of 300-400 mg b.i.d. or t.i.d.
310042|NCT00216476|B1|Baseline|Risperidone LAI|intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
310043|NCT00216476|P3|Participant Flow|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
310044|NCT00216476|P2|Participant Flow|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
310045|NCT00216476|P1|Participant Flow|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
310046|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
310047|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
310048|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
310049|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
310062|NCT00216671|B2|Baseline|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
310063|NCT00216671|B1|Baseline|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
310064|NCT00216671|P2|Participant Flow|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
310065|NCT00216671|P1|Participant Flow|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
310066|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
310067|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
310068|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
310109|NCT00217087|P2|Participant Flow|Photodynamic Therapy|Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
310069|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
310070|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
310071|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
310072|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
310073|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
310074|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
310075|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
310076|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
310150|NCT00217490|B4|Baseline|Physcial Activity-computer|Physical activity counseling delivered by computer only
310077|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
310078|NCT00216671|E2|Reported Event|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
310079|NCT00216671|E1|Reported Event|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
310080|NCT00216736|B3|Baseline|Total|Total of all reporting groups
310081|NCT00216736|B2|Baseline|Dexamethasone|
310082|NCT00216736|B1|Baseline|Placebo|
310083|NCT00216736|P2|Participant Flow|Dexamethasone|
310084|NCT00216736|P1|Participant Flow|Placebo|
310085|NCT00216736|O2|Outcome|Dexamethasone|
310086|NCT00216736|O1|Outcome|Placebo|
310087|NCT00216736|O2|Outcome|Dexamethasone|
310088|NCT00216736|O1|Outcome|Placebo|
310089|NCT00216736|O2|Outcome|Dexamethasone|
310090|NCT00216736|O1|Outcome|Placebo|
310091|NCT00216736|O2|Outcome|Dexamethasone|
310092|NCT00216736|O1|Outcome|Placebo|
310093|NCT00216736|E2|Reported Event|Dexamethasone|
310094|NCT00216736|E1|Reported Event|Placebo|
310095|NCT00217022|B3|Baseline|Total|Total of all reporting groups
310096|NCT00217022|B2|Baseline|Placebo|three tablets daily
310097|NCT00217022|B1|Baseline|Budesonide|9 mg daily
310098|NCT00217022|P2|Participant Flow|Placebo|three tablets daily
310099|NCT00217022|P1|Participant Flow|Budesonide|9 mg daily
310100|NCT00217022|O2|Outcome|Placebo|three tablets daily
310101|NCT00217022|O1|Outcome|Budesonide|9 mg daily
310102|NCT00217022|O2|Outcome|Placebo|three tablets daily
310103|NCT00217022|O1|Outcome|Budesonide|9 mg daily
310104|NCT00217022|E2|Reported Event|Placebo|three tablets daily
310105|NCT00217022|E1|Reported Event|Budesonide|9 mg daily
310106|NCT00217087|B3|Baseline|Total|Total of all reporting groups
310107|NCT00217087|B2|Baseline|Photodynamic Therapy|patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
310108|NCT00217087|B1|Baseline|Endoscopic Mucosl Resection|patients will undergo endoscopic mucosal resection at time of endoscopy if indicated
310110|NCT00217087|P1|Participant Flow|Endoscopic Mucosal Resection|Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
310111|NCT00217087|O2|Outcome|Endoscopic Mucosal Resection and Photodynamic Therapy|Patients will have EMR (if indicated at time of endoscopy) followed by photodynamic therapy
310112|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection|Patients will undergo EMR at time of endoscopy if indicated.
310113|NCT00217087|O4|Outcome|Photodynamic Therapy FISH NEGATIVE|FISH cytology results prior to therapy were negative
310114|NCT00217087|O3|Outcome|Photodynamic Therapy FISH POSITIVE|FISH cytology results were positive prior to therapy
310115|NCT00217087|O2|Outcome|Endoscopic Mucosal Resection FISH Positive Positive|FISH cytology results were positive prior to therapy
310116|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection FISH Polysomy Negative|FISH cytology results prior to therapy were negative
310117|NCT00217087|O2|Outcome|Photodynamic Therapy|Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
310118|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection|Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
310119|NCT00217087|E2|Reported Event|Photodynamic Therapy|patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
310120|NCT00217087|E1|Reported Event|Endoscopic Mucosl Resection|patients will undergo endoscopic mucosal resection at time of endoscopy if indicated
310121|NCT00217399|B1|Baseline|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
310122|NCT00217399|P1|Participant Flow|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
310123|NCT00217399|O1|Outcome|Circulating Endothelial Cells|All patients received sorafenib and anastrozole. Blood was drawn prior to beginning treatment and at set time points to analyze for circulating endothelial cells by flow cytometry
310124|NCT00217399|O1|Outcome|Sorefenib and Anastrozole|All patients receive sorafenib (400mg by mouth twice daily) and anastrazole (1 mg by mouth daily)
310125|NCT00217399|O1|Outcome|Sorafenib and Anastrozole|All patients receive sorafenib and anastrozole.
310126|NCT00217399|E1|Reported Event|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
310127|NCT00217425|B1|Baseline|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
315866|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
310128|NCT00217425|P1|Participant Flow|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
310129|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
310130|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
310170|NCT00217581|B1|Baseline|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
310131|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
310132|NCT00217425|E1|Reported Event|Treatment (ACHOP Followed by MA)|Adverse events in all treated patients regardless of eligibility.
310133|NCT00217438|B3|Baseline|Total|Total of all reporting groups
310134|NCT00217438|B2|Baseline|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:
Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
310135|NCT00217438|B1|Baseline|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:
Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
310136|NCT00217438|P2|Participant Flow|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:
Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
315867|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
310137|NCT00217438|P1|Participant Flow|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:
Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
310138|NCT00217438|O2|Outcome|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:
Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
310139|NCT00217438|O1|Outcome|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:
Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
310140|NCT00217438|O2|Outcome|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:
Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
310380|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
310141|NCT00217438|O1|Outcome|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:
Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
310142|NCT00217438|E2|Reported Event|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:
Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
310143|NCT00217438|E1|Reported Event|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:
Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
310144|NCT00217464|B1|Baseline|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.
fulvestrant: intramuscularly"
310145|NCT00217464|P1|Participant Flow|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.
fulvestrant: intramuscularly"
310146|NCT00217464|O1|Outcome|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.
fulvestrant: intramuscularly"
310147|NCT00217464|O1|Outcome|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.
fulvestrant: intramuscularly"
310151|NCT00217490|B3|Baseline|Combined|Dietary counseling delivered using computer program and nutritionist
310154|NCT00217490|P4|Participant Flow|Physcial Activity-computer|Physical activity counseling delivered by computer only
310155|NCT00217490|P3|Participant Flow|Combined|Dietary counseling delivered using computer program and nutritionist
310156|NCT00217490|P2|Participant Flow|Counseling Only|Dietary counseling delivered by nutritionist
310157|NCT00217490|P1|Participant Flow|Computer Only|Dietary Counseling delivered by interactive computer
310158|NCT00217490|O4|Outcome|Physcial Activity-computer|Physical activity counseling delivered by computer only
310159|NCT00217490|O3|Outcome|Combined|Dietary counseling delivered using computer program and nutritionist
310160|NCT00217490|O2|Outcome|Counseling Only|Dietary counseling delivered by nutritionist
310161|NCT00217490|O1|Outcome|Computer Only|Dietary Counseling delivered by interactive computer
310162|NCT00217490|O4|Outcome|Physcial Activity-computer|"Physical activity counseling delivered by computer only
physical activity counseling via computer: An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan"
310163|NCT00217490|O3|Outcome|Combined|"Dietary counseling delivered using computer program and nutritionist
combined computer and nutritionist: An interactive computer program plus one on one nutrition counseling that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
310164|NCT00217490|O2|Outcome|Counseling Only|"Dietary counseling delivered by nutritionist
dietary counseling via nutritionist: A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
310165|NCT00217490|O1|Outcome|Computer Only|"Dietary Counseling delivered by interactive computer
dietary counseling via computer: An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
310166|NCT00217490|E4|Reported Event|Physcial Activity-computer|Physical activity counseling delivered by computer only
310167|NCT00217490|E3|Reported Event|Combined|Dietary counseling delivered using computer program and nutritionist
310168|NCT00217490|E2|Reported Event|Counseling Only|Dietary counseling delivered by nutritionist
310169|NCT00217490|E1|Reported Event|Computer Only|Dietary Counseling delivered by interactive computer
310188|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
310171|NCT00217581|P1|Participant Flow|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
310172|NCT00217581|O1|Outcome|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
310173|NCT00217581|E1|Reported Event|Docetaxel, Oxaliplatin & Bevacizumab|"Administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; 1st cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins.
Bevacizumab: Administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins.
Docetaxel: Must be administered 2nd after Bevacizumab then Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;"
310174|NCT00217620|B1|Baseline|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
310175|NCT00217620|P1|Participant Flow|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
310176|NCT00217620|O1|Outcome|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
310177|NCT00217620|O3|Outcome|Vascular Sarcomas|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
310178|NCT00217620|O2|Outcome|Liposarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
310179|NCT00217620|O1|Outcome|Leiomyosarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
310180|NCT00217620|O4|Outcome|Total|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
310181|NCT00217620|O3|Outcome|Vascular Sarcomas|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
310182|NCT00217620|O2|Outcome|Liposarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
310183|NCT00217620|O1|Outcome|Leiomyosarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
310184|NCT00217620|E1|Reported Event|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
310185|NCT00217672|B1|Baseline|Docetaxel + Bevacizumab|"docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
A total of 104 participants were screened for the study. Twenty six participants did not meet eligibility criteria and 2 withdrew consent.
Seventy six participants were registered to the Treatment Period, 7 to arm A and 69 to arm B. Six out of 7 participants randomized to arm A elected to cross over to arm B once bevacizumab became available. Two out of the 69 participants randomized to arm B were found ineligible and taken off study before receiving treatment. As a result, the efficacy analysis was performed on 67 patients."
310186|NCT00217672|P2|Participant Flow|Docetaxel|docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
310187|NCT00217672|P1|Participant Flow|Docetaxel+Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
310443|NCT00218634|B1|Baseline|CBT-AD|Cognitive behavioral therapy for adherence and depression
310189|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
310190|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
310191|NCT00217672|E1|Reported Event|Docetaxel and/or Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
310192|NCT00217724|B1|Baseline|Entire Study Population|Includes those randomized to Arms 1 and 2 in both course 1 and 2.
310193|NCT00217724|P2|Participant Flow|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
310194|NCT00217724|P1|Participant Flow|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
310195|NCT00217724|O2|Outcome|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
310196|NCT00217724|O1|Outcome|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
310197|NCT00217724|O2|Outcome|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
310198|NCT00217724|O1|Outcome|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
310199|NCT00217724|E2|Reported Event|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
310200|NCT00217724|E1|Reported Event|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
310201|NCT00217971|B3|Baseline|Total|Total of all reporting groups
310202|NCT00217971|B2|Baseline|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
310203|NCT00217971|B1|Baseline|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
310204|NCT00217971|P2|Participant Flow|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
310205|NCT00217971|P1|Participant Flow|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
310206|NCT00217971|O2|Outcome|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
310207|NCT00217971|O1|Outcome|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
310208|NCT00217971|E2|Reported Event|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
310209|NCT00217971|E1|Reported Event|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
310210|NCT00218023|B5|Baseline|Total|Total of all reporting groups
310211|NCT00218023|B4|Baseline|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310266|NCT00218296|B1|Baseline|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
310472|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
310212|NCT00218023|B3|Baseline|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310213|NCT00218023|B2|Baseline|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310214|NCT00218023|B1|Baseline|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310215|NCT00218023|P4|Participant Flow|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310216|NCT00218023|P3|Participant Flow|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310364|NCT00206440|E1|Reported Event|Esomeprazole|The frist dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
310217|NCT00218023|P2|Participant Flow|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310218|NCT00218023|P1|Participant Flow|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310219|NCT00218023|O4|Outcome|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310220|NCT00218023|O3|Outcome|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310221|NCT00218023|O2|Outcome|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310222|NCT00218023|O1|Outcome|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310267|NCT00218296|P2|Participant Flow|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated by using nicotine lozenge or ST brand switching resulting in reduced nicotine exposure.
310223|NCT00218023|O4|Outcome|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310224|NCT00218023|O3|Outcome|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310225|NCT00218023|O2|Outcome|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310226|NCT00218023|O1|Outcome|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310227|NCT00218023|E4|Reported Event|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310228|NCT00218023|E3|Reported Event|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310229|NCT00218023|E2|Reported Event|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310230|NCT00218023|E1|Reported Event|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
310231|NCT00218062|B5|Baseline|Total|Total of all reporting groups
310232|NCT00218062|B4|Baseline|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310233|NCT00218062|B3|Baseline|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310234|NCT00218062|B2|Baseline|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310268|NCT00218296|P1|Participant Flow|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks of nicotine patch and behavioral counseling during the 6 week intervention period.
310473|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
310235|NCT00218062|B1|Baseline|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310236|NCT00218062|P4|Participant Flow|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310237|NCT00218062|P3|Participant Flow|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310238|NCT00218062|P2|Participant Flow|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310239|NCT00218062|P1|Participant Flow|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310240|NCT00218062|O4|Outcome|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310241|NCT00218062|O3|Outcome|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310242|NCT00218062|O2|Outcome|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310243|NCT00218062|O1|Outcome|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310244|NCT00218062|O4|Outcome|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310269|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
310270|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
310474|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
310245|NCT00218062|O3|Outcome|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310246|NCT00218062|O2|Outcome|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310247|NCT00218062|O1|Outcome|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310248|NCT00218062|O4|Outcome|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310249|NCT00218062|O3|Outcome|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310250|NCT00218062|O2|Outcome|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310287|NCT00218335|B1|Baseline|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310251|NCT00218062|O1|Outcome|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310252|NCT00218062|O4|Outcome|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310253|NCT00218062|O3|Outcome|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310254|NCT00218062|O2|Outcome|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310255|NCT00218062|O1|Outcome|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310256|NCT00218062|O4|Outcome|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310257|NCT00218062|O3|Outcome|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310258|NCT00218062|O2|Outcome|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310259|NCT00218062|O1|Outcome|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310260|NCT00218062|E4|Reported Event|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310288|NCT00218335|P4|Participant Flow|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310289|NCT00218335|P3|Participant Flow|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310365|NCT00206518|B3|Baseline|Total|Total of all reporting groups
310444|NCT00218634|P2|Participant Flow|ETAU|Enhanced Treatment as Usual
328535|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
310261|NCT00218062|E3|Reported Event|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310262|NCT00218062|E2|Reported Event|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310263|NCT00218062|E1|Reported Event|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
310264|NCT00218296|B3|Baseline|Total|Total of all reporting groups
310265|NCT00218296|B2|Baseline|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
310604|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
310271|NCT00218296|O2|Outcome|Reduction Group|Reduction group subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
310272|NCT00218296|O1|Outcome|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
310273|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
310274|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
310275|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
310276|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
310277|NCT00218296|O2|Outcome|Reduction Group|Reduction group subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
310278|NCT00218296|O1|Outcome|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
310279|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
310280|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
310281|NCT00218296|E2|Reported Event|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
310282|NCT00218296|E1|Reported Event|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
310283|NCT00218335|B5|Baseline|Total|Total of all reporting groups
310284|NCT00218335|B4|Baseline|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310285|NCT00218335|B3|Baseline|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310286|NCT00218335|B2|Baseline|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310290|NCT00218335|P2|Participant Flow|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310291|NCT00218335|P1|Participant Flow|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310292|NCT00218335|O2|Outcome|Control Participants|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310293|NCT00218335|O1|Outcome|Intervention Participants|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310294|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310295|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310296|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310297|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310298|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310299|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310300|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310605|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
310301|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310302|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310303|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310304|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310305|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310306|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310307|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310308|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310309|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310310|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310311|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310312|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
328536|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
310313|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310314|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310315|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310316|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310317|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310318|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310319|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310320|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310321|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310322|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310323|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310475|NCT00222729|E1|Reported Event|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
310476|NCT00223236|B3|Baseline|Total|Total of all reporting groups
310324|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310325|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310326|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310327|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310328|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310329|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310330|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310331|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310332|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310333|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310334|NCT00218335|O2|Outcome|Control Participants|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310363|NCT00206440|E2|Reported Event|Sugar Pill|The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
310445|NCT00218634|P1|Participant Flow|CBT-AD|Cognitive behavioral therapy for adherence and depression
310335|NCT00218335|O1|Outcome|Intervention Participants|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310336|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310337|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310338|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310339|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310340|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310341|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310342|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310343|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310344|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310345|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310346|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310347|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310348|NCT00218335|E4|Reported Event|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
310349|NCT00218335|E3|Reported Event|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
310350|NCT00218335|E2|Reported Event|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
310351|NCT00218335|E1|Reported Event|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
310352|NCT00206427|B1|Baseline|GW572016 1500mg|patients received GW572016 1500mg daily
310353|NCT00206427|P1|Participant Flow|GW572016 1500mg|The study had only 1 treatment group and all patient had GW572016 1500mg daily.
310354|NCT00206427|O1|Outcome|GW572016 1500mg|patients received GW572016 1500mg daily
310355|NCT00206427|E1|Reported Event|GW572016 1500mg|patients received GW572016 1500mg daily
310356|NCT00206440|B3|Baseline|Total|Total of all reporting groups
310357|NCT00206440|B2|Baseline|Sugar Pill|Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
310358|NCT00206440|B1|Baseline|Esomeprazole|Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
310359|NCT00206440|P2|Participant Flow|Sugar Pill|Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
310360|NCT00206440|P1|Participant Flow|Esomeprazole|Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
310361|NCT00206440|O2|Outcome|Sugar Pill|The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
310362|NCT00206440|O1|Outcome|Esomeprazole|The first dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
310379|NCT00206726|P1|Participant Flow|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
310366|NCT00206518|B2|Baseline|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan"
310367|NCT00206518|B1|Baseline|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
310368|NCT00206518|P2|Participant Flow|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan"
310369|NCT00206518|P1|Participant Flow|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
310370|NCT00206518|O2|Outcome|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan"
310394|NCT00212264|O2|Outcome|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies
Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks
Biofeedback: Pelvic Floor Muscle training via biofeedback"
310371|NCT00206518|O1|Outcome|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
310372|NCT00206518|O2|Outcome|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan"
310373|NCT00206518|O1|Outcome|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
310374|NCT00206518|O2|Outcome|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan"
310375|NCT00206518|O1|Outcome|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
310376|NCT00206518|E2|Reported Event|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan"
310377|NCT00206518|E1|Reported Event|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
310378|NCT00206726|B1|Baseline|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
310381|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
310382|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
310383|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
310384|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
310385|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
310386|NCT00206726|E1|Reported Event|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
310387|NCT00212264|B4|Baseline|Total|Total of all reporting groups
310388|NCT00212264|B3|Baseline|Placebo Comparator|No treatment control
310389|NCT00212264|B2|Baseline|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies
Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks
Biofeedback: Pelvic Floor Muscle training via biofeedback"
310390|NCT00212264|B1|Baseline|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
310391|NCT00212264|P3|Participant Flow|Placebo Comparator|No treatment control
310392|NCT00212264|P2|Participant Flow|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies
Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks
Biofeedback: Pelvic Floor Muscle training via biofeedback"
310393|NCT00212264|P1|Participant Flow|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
310395|NCT00212264|O1|Outcome|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
310397|NCT00212264|O2|Outcome|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies
Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks
Biofeedback: Pelvic Floor Muscle training via biofeedback"
310398|NCT00212264|O1|Outcome|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
310399|NCT00212264|E3|Reported Event|Placebo Comparator|No treatment control
310400|NCT00212264|E2|Reported Event|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies
Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks
Biofeedback: Pelvic Floor Muscle training via biofeedback"
310401|NCT00212264|E1|Reported Event|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)
Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
310402|NCT00212355|B1|Baseline|NPC-02|"zinc acetate
NPC-02: zinc acetate"
310403|NCT00212355|P1|Participant Flow|NPC-02|"zinc acetate
NPC-02: zinc acetate"
310404|NCT00212355|O1|Outcome|NPC-02|"zinc acetate
NPC-02: zinc acetate"
310405|NCT00212355|E1|Reported Event|NPC-02|"zinc acetate
NPC-02: zinc acetate"
310406|NCT00218439|B3|Baseline|Total|Total of all reporting groups
310407|NCT00218439|B2|Baseline|Paroxetine First 4 Weeks, Then Placebo for 4 Weeks|Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
310408|NCT00218439|B1|Baseline|Placebo First 4 Weeks, Then Paroxetine for 4 Weeks|Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
310409|NCT00218439|P2|Participant Flow|Paroxetine (4 Weeks) the Placebo (4 Weeks)|Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
310410|NCT00218439|P1|Participant Flow|Placebo (4 Weeks) Then Paroxetine (4 Weeks)|Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
310411|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
310412|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
310413|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
310414|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
310446|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
310415|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
310416|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
310417|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
310418|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in diastolic blood pressure fom Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
310419|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
310420|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
310421|NCT00218439|E2|Reported Event|During 4 Weeks of Paroxetine|Participants received paroxetine 10 mg once daily for 1 week followed by 20 mg once daily for 3 weeks
310422|NCT00218439|E1|Reported Event|During 4 Weeks of Placebo|Participants receive placebo daily for 4 weeks
310423|NCT00218465|B3|Baseline|Total|Total of all reporting groups
310424|NCT00218465|B2|Baseline|Placebo|Placebo group for 5 week relapse prevention trial.
310425|NCT00218465|B1|Baseline|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
310426|NCT00218465|P2|Participant Flow|Placebo|Placebo group for 5 week relapse prevention trial.
310427|NCT00218465|P1|Participant Flow|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
310428|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
310429|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
310430|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
310431|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
310432|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
310433|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
310434|NCT00218465|E2|Reported Event|Placebo|Placebo group for 5 week relapse prevention trial.
310435|NCT00218465|E1|Reported Event|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
310436|NCT00218543|B1|Baseline|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
310437|NCT00218543|P1|Participant Flow|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
310438|NCT00218543|O1|Outcome|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
310439|NCT00218543|O1|Outcome|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
310440|NCT00218543|E1|Reported Event|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
310441|NCT00218634|B3|Baseline|Total|Total of all reporting groups
310442|NCT00218634|B2|Baseline|ETAU|Enhanced Treatment as Usual
310449|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
310450|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
310451|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
310452|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
310453|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
310454|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
310455|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
310456|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
310457|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
310458|NCT00218634|O2|Outcome|Enhanced Treatment as Usual|Enhanced treatment as usual (ETAU).
310459|NCT00218634|O1|Outcome|Cognitive Behavioral Therapy for Adherence and Depression|Cognitive behavioral therapy focusing on treating depression and adherence to medication (CBT-AD).
310460|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
310461|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
310462|NCT00218634|E2|Reported Event|ETAU|Enhanced Treatment as Usual
310463|NCT00218634|E1|Reported Event|CBT-AD|Cognitive behavioral therapy for adherence and depression
310464|NCT00222105|B1|Baseline|Arm 1|"Doxil, Thalidomide, Dexamethasone
Doxil: Doxil 40 mg/m2 IV day 1
Thalidomide: 50-100 mg day 1-28
Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
310465|NCT00222105|P1|Participant Flow|Arm 1|"Doxil, Thalidomide, Dexamethasone
Doxil: Doxil 40 mg/m2 IV day 1
Thalidomide: 50-100 mg day 1-28
Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
310466|NCT00222105|O1|Outcome|Arm 1|"Doxil, Thalidomide, Dexamethasone
Doxil: Doxil 40 mg/m2 IV day 1
Thalidomide: 50-100 mg day 1-28
Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
310467|NCT00222105|O1|Outcome|Arm 1|"Doxil, Thalidomide, Dexamethasone
Doxil: Doxil 40 mg/m2 IV day 1
Thalidomide: 50-100 mg day 1-28
Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
310468|NCT00222105|E1|Reported Event|Arm 1|"Doxil, Thalidomide, Dexamethasone
Doxil: Doxil 40 mg/m2 IV day 1
Thalidomide: 50-100 mg day 1-28
Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
310469|NCT00222729|B1|Baseline|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
310470|NCT00222729|P1|Participant Flow|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
310471|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
310477|NCT00223236|B2|Baseline|Placebo|Inactive ingredient matching the active medication in appearance
310478|NCT00223236|B1|Baseline|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
310479|NCT00223236|P2|Participant Flow|Placebo|Inactive ingredient matching the active medication in appearance
310480|NCT00223236|P1|Participant Flow|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
310481|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
310482|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
310483|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
310484|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
310485|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
310486|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
310487|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
310488|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
310489|NCT00223236|E2|Reported Event|Placebo|Inactive ingredient matching the active medication in appearance
310490|NCT00223236|E1|Reported Event|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
310491|NCT00223496|B1|Baseline|Aripiprazole|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
310492|NCT00223496|P1|Participant Flow|Aripiprazole Plus Divalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
328537|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
310493|NCT00223496|O1|Outcome|Aripiprazole Plus Divalalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
310494|NCT00223496|E1|Reported Event|Aripiprazole Plus Divalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
310495|NCT00223652|B3|Baseline|Total|Total of all reporting groups
310496|NCT00223652|B2|Baseline|Treatment as Usual|Treatment as usual control.
310497|NCT00223652|B1|Baseline|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy
Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
310498|NCT00223652|P2|Participant Flow|Treatment as Usual|Treatment as usual control.
310499|NCT00223652|P1|Participant Flow|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy
Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
310500|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
310501|NCT00223652|O1|Outcome|Telephone Cognitive Behavioral Therapy|"Telephone cognitive behavioral therapy
Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
310502|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
310503|NCT00223652|O1|Outcome|Telephone Cognitive Behavioral Therapy|"Telephone cognitive behavioral therapy
Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
310504|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
310505|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy
Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
310506|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
310563|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
310606|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
310507|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy
Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
310508|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
310509|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy
Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
310510|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
310511|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy
Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
310512|NCT00223652|E2|Reported Event|Treatment as Usual|Treatment as usual control.
310513|NCT00223652|E1|Reported Event|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy
Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
310514|NCT00223678|B3|Baseline|Total|Total of all reporting groups
310515|NCT00223678|B2|Baseline|CYA/Prograf|Patient will remain on calcineurin inhibitor,CYA/Prograf
310516|NCT00223678|B1|Baseline|Rapamycin|"pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin
Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15"
310517|NCT00223678|P2|Participant Flow|CYA/Prograf|Patient will remain on calcineurin inhibitor,CYA/Prograf
310518|NCT00223678|P1|Participant Flow|Rapamycin|"pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin
Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15"
310519|NCT00223678|O2|Outcome|CNI Group|Patient will remain on calcineurin inhibitor with a low target serum levels 50ng/ml to 125ng/mg 12 hour trough
310520|NCT00223678|O1|Outcome|Rapamycin Group|pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin.Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15
310521|NCT00223678|E2|Reported Event|CNI Group|
310524|NCT00223704|B3|Baseline|HOE 140 Group|Bradykinin B2 receptor antagonist
310525|NCT00223704|B2|Baseline|Aminocaproic Acid Group|Aminocaproic acid is an antifibrinolytic drug
310526|NCT00223704|B1|Baseline|Placebo Group|Placebo was normal saline
310527|NCT00223704|P3|Participant Flow|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
310528|NCT00223704|P2|Participant Flow|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
310529|NCT00223704|P1|Participant Flow|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
310530|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
310531|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
310532|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
310533|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
310534|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
310535|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
310536|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
310603|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
310537|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
310538|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
310539|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
310540|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
310541|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
310542|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
310543|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
310544|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
310545|NCT00223704|E3|Reported Event|HOE 140 Group|Bradykinin B2 receptor antagonist
310546|NCT00223704|E2|Reported Event|Aminocaproic Acid Group|Aminocaproic acid is an antifibrinolytic drug
310547|NCT00223704|E1|Reported Event|Placebo Group|Placebo was normal saline
310579|NCT00223821|B2|Baseline|Arm 2|"drug therapy + behavioral training
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
310580|NCT00223821|B1|Baseline|Arm 1|"drug therapy alone
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects."
310639|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
310548|NCT00223795|B1|Baseline|Baseline Characteristics All Subjects|Community-dwelling patients with unilateral knee pain on movement which they scored at >35 mm on a 100-mm visual analogue scale (VAS) for most days of the previous month. Other inclusion criteria included having a weight less than 300 pounds, no cane use for the past 30 days, fulfillment of the American College of Rheumatology criteria for knee OA , and radiographic Kellgren-Lawrence scale knee OA grade > 1. We excluded individuals who had knee trauma or surgery, including arthroscopic surgery, within the past six months, upper body weakness, injury or amputation to the lower extremity joints, symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee, poor health that would impair compliance or assessment such as shortness of breath with exertion, or neurological disease including vestibular dysfunction, or impaired vision.
310549|NCT00223795|P2|Participant Flow|Arm 2 - Cane|Single point cane first, then continue with single point cane
310550|NCT00223795|P1|Participant Flow|Arm 1 - Control/Crossover|No cane first, then single point cane
310551|NCT00223795|O2|Outcome|Arm 2- Cane Users|Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants given a cane to use at home during the first intervention period and then for four months after the first intervention period.
310552|NCT00223795|O1|Outcome|Arm 1 - Waiting Control|Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants not given a cane to use at home during the intervention period. They were given a cane to use for four months after the first intervention period
310553|NCT00223795|E3|Reported Event|Arm 2- Single Point Cane|single point cane for 8 weeks then single point cane for next 4 months
310554|NCT00223795|E2|Reported Event|Arm 1 - Intervention - Crossover to Cane|Given single point cane to use for 4 months following 8 weeks without a cane
310555|NCT00223795|E1|Reported Event|Arm 1: Intervention - no Cane for First 8 Weeks|No cane for first 8 weeks
310556|NCT00223808|B4|Baseline|Total|Total of all reporting groups
310557|NCT00223808|B3|Baseline|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
310558|NCT00223808|B2|Baseline|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
310559|NCT00223808|B1|Baseline|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
310560|NCT00223808|P3|Participant Flow|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
310561|NCT00223808|P2|Participant Flow|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
310562|NCT00223808|P1|Participant Flow|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
310689|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
310564|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
310565|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
310566|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
310567|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
310568|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
310569|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
310570|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
310571|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
310572|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
310573|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
310574|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
310575|NCT00223808|E3|Reported Event|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
310576|NCT00223808|E2|Reported Event|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
310577|NCT00223808|E1|Reported Event|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
310578|NCT00223821|B3|Baseline|Total|Total of all reporting groups
310637|NCT00224042|P1|Participant Flow|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
310638|NCT00224042|O2|Outcome|Oral Iron|
310640|NCT00224042|O2|Outcome|Oral Iron|
310581|NCT00223821|P2|Participant Flow|Drug Therapy + Behavioral Training|"drug therapy + behavioral training
Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects.
Behavior Training: Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
310582|NCT00223821|P1|Participant Flow|Drug Therapy Alone|"drug therapy alone
Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects."
310583|NCT00223821|O2|Outcome|Drug Therapy + Behavioral Training|"Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
310584|NCT00223821|O1|Outcome|Drug Therapy Alone|Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
310585|NCT00223821|O2|Outcome|Drug Therapy + Behavioral Training|"Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
310586|NCT00223821|O1|Outcome|Drug Therapy Alone|Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
310587|NCT00223821|E2|Reported Event|Arm 2|"drug therapy + behavioral training
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
310588|NCT00223821|E1|Reported Event|Arm 1|"drug therapy alone
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects."
310589|NCT00223977|B4|Baseline|Total|Total of all reporting groups
310590|NCT00223977|B3|Baseline|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
310591|NCT00223977|B2|Baseline|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
310592|NCT00223977|B1|Baseline|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
310593|NCT00223977|P3|Participant Flow|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
310594|NCT00223977|P2|Participant Flow|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
310595|NCT00223977|P1|Participant Flow|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
310596|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
310597|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
310598|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
310599|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
310600|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
310601|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
310602|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
310607|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
310608|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
310609|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
310610|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
310611|NCT00223977|E3|Reported Event|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
310612|NCT00223977|E2|Reported Event|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
310613|NCT00223977|E1|Reported Event|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
310614|NCT00224003|B1|Baseline|Sodium Ferric Gluconate Complex|
310615|NCT00224003|P1|Participant Flow|Sodium Ferric Gluconate Complex|
310616|NCT00224003|O1|Outcome|Sodium Ferric Gluconate Complex|
310617|NCT00224003|O1|Outcome|Sodium Ferric Gluconate Complex|
310618|NCT00224016|B3|Baseline|Total|Total of all reporting groups
310619|NCT00224016|B2|Baseline|Oral Oxybutynin|Oxybutynin tablets
310620|NCT00224016|B1|Baseline|Oxybutynin TDS|Oxybutynin Transdermal System
310621|NCT00224016|P2|Participant Flow|Oral Oxybutynin|Oxybutynin tablets
310622|NCT00224016|P1|Participant Flow|Oxybutynin TDS|Oxybutynin Transdermal System
310623|NCT00224016|O2|Outcome|Oral Oxybutynin|Oxybutynin tablets
310624|NCT00224016|O1|Outcome|Oxybutynin TDS|Oxybutynin Transdermal System
310625|NCT00224016|O2|Outcome|Oral Oxybutynin|Oxybutynin tablets
310626|NCT00224016|O1|Outcome|Oxybutynin TDS|Oxybutynin Transdermal System
310627|NCT00224016|E2|Reported Event|Oral Oxybutynin|Oxybutynin tablets
310628|NCT00224016|E1|Reported Event|Oxybutynin TDS|Oxybutynin Transdermal System
310629|NCT00224029|B1|Baseline|Oxybutynin Transdermal System|
310630|NCT00224029|P1|Participant Flow|Oxybutynin Transdermal System|
310631|NCT00224029|O1|Outcome|Oxybutynin Transdermal System|
310632|NCT00224029|E1|Reported Event|Oxybutynin Transdermal System|
310633|NCT00224042|B3|Baseline|Total|Total of all reporting groups
310634|NCT00224042|B2|Baseline|Oral Iron|
310635|NCT00224042|B1|Baseline|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
310636|NCT00224042|P2|Participant Flow|Oral Iron|
310641|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
310642|NCT00224042|O2|Outcome|Oral Iron|
310643|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
310644|NCT00224042|O2|Outcome|Oral Iron|
310645|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
310646|NCT00224042|E2|Reported Event|Oral Iron|
310647|NCT00224042|E1|Reported Event|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
310648|NCT00224055|B3|Baseline|Total|Total of all reporting groups
310649|NCT00224055|B2|Baseline|Oral Iron|
310650|NCT00224055|B1|Baseline|IV Iron|
310651|NCT00224055|P2|Participant Flow|Oral Iron|
310652|NCT00224055|P1|Participant Flow|IV Iron|
310653|NCT00224055|O2|Outcome|Oral Iron|
310654|NCT00224055|O1|Outcome|IV Iron|
310655|NCT00224055|O2|Outcome|Oral Iron|
310656|NCT00224055|O1|Outcome|IV Iron|
310657|NCT00224055|E2|Reported Event|Oral Iron|
310658|NCT00224055|E1|Reported Event|IV Iron|
310659|NCT00224107|B3|Baseline|Total|Total of all reporting groups
310660|NCT00224107|B2|Baseline|Placebo|Matching placebo capsule once daily with food
310661|NCT00224107|B1|Baseline|Silodosin|Silodosin 8 mg once daily with food
310662|NCT00224107|P2|Participant Flow|Placebo|Matching placebo capsule once daily with food
310663|NCT00224107|P1|Participant Flow|Silodosin|Silodosin 8 mg once daily with food
310664|NCT00224107|O2|Outcome|Placebo|Matching placebo capsule once daily with food
310665|NCT00224107|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
310666|NCT00224107|O2|Outcome|Placebo|Matching placebo capsule once daily with food
310667|NCT00224107|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
310668|NCT00224107|E2|Reported Event|Placebo|Matching placebo capsule once daily with food
310669|NCT00224107|E1|Reported Event|Silodosin|Silodosin 8 mg once daily with food
310670|NCT00215540|B4|Baseline|Total|Total of all reporting groups
310671|NCT00215540|B3|Baseline|Placebo|Sham air using 3.0 mL/kg volume of air
310672|NCT00215540|B2|Baseline|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310673|NCT00215540|B1|Baseline|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310674|NCT00215540|P3|Participant Flow|Placebo|Sham air using 3.0 mL/kg volume of air
310675|NCT00215540|P2|Participant Flow|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310676|NCT00215540|P1|Participant Flow|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310677|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
310678|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310679|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310680|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
310681|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310682|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310683|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
310684|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310685|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310686|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
310687|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310688|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310690|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310691|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310692|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
310693|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310694|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310695|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
310696|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310697|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310698|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
310699|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310700|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310701|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
310702|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310703|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310704|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
310705|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310706|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310707|NCT00215540|E3|Reported Event|Placebo|Sham air using 3.0 mL/kg volume of air
310708|NCT00215540|E2|Reported Event|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
310709|NCT00215540|E1|Reported Event|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
310710|NCT00215553|B8|Baseline|Total|Total of all reporting groups
310711|NCT00215553|B7|Baseline|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
310712|NCT00215553|B6|Baseline|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310713|NCT00215553|B5|Baseline|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310714|NCT00215553|B4|Baseline|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310715|NCT00215553|B3|Baseline|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310716|NCT00215553|B2|Baseline|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310717|NCT00215553|B1|Baseline|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
310718|NCT00215553|P7|Participant Flow|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
310719|NCT00215553|P6|Participant Flow|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310720|NCT00215553|P5|Participant Flow|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310721|NCT00215553|P4|Participant Flow|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310722|NCT00215553|P3|Participant Flow|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310723|NCT00215553|P2|Participant Flow|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310724|NCT00215553|P1|Participant Flow|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
310725|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
310726|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310727|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310728|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310729|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310730|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310731|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
310732|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
310733|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310734|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310735|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310736|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310737|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310738|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
310739|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
310740|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310741|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310742|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310743|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310892|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|
310744|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310745|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
310746|NCT00215553|E7|Reported Event|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
310747|NCT00215553|E6|Reported Event|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310748|NCT00215553|E5|Reported Event|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310749|NCT00215553|E4|Reported Event|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
310750|NCT00215553|E3|Reported Event|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310751|NCT00215553|E2|Reported Event|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
310752|NCT00215553|E1|Reported Event|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
310753|NCT00215657|B9|Baseline|Total|Total of all reporting groups
310754|NCT00215657|B8|Baseline|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
310755|NCT00215657|B7|Baseline|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
310756|NCT00215657|B6|Baseline|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
310757|NCT00215657|B5|Baseline|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
310758|NCT00215657|B4|Baseline|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
310759|NCT00215657|B3|Baseline|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
310760|NCT00215657|B2|Baseline|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
310761|NCT00215657|B1|Baseline|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
310762|NCT00215657|P8|Participant Flow|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
310763|NCT00215657|P7|Participant Flow|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
310764|NCT00215657|P6|Participant Flow|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
310765|NCT00215657|P5|Participant Flow|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
310766|NCT00215657|P4|Participant Flow|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
310767|NCT00215657|P3|Participant Flow|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
310768|NCT00215657|P2|Participant Flow|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
310769|NCT00215657|P1|Participant Flow|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
310770|NCT00215657|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
310771|NCT00215657|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
310772|NCT00215657|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
310773|NCT00215657|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
310774|NCT00215657|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
310775|NCT00215657|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
310776|NCT00215657|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
310777|NCT00215657|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
310778|NCT00215657|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
310779|NCT00215657|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
310780|NCT00215657|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
310781|NCT00215657|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
310782|NCT00215657|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
310783|NCT00215657|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
310784|NCT00215657|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
310785|NCT00215657|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
310786|NCT00215657|E8|Reported Event|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
310787|NCT00215657|E7|Reported Event|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
310788|NCT00215657|E6|Reported Event|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
310789|NCT00215657|E5|Reported Event|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
310790|NCT00215657|E4|Reported Event|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
310791|NCT00215657|E3|Reported Event|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
310792|NCT00215657|E2|Reported Event|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
310793|NCT00215657|E1|Reported Event|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
310794|NCT00215683|B4|Baseline|Total|Total of all reporting groups
310795|NCT00215683|B3|Baseline|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310796|NCT00215683|B2|Baseline|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310797|NCT00215683|B1|Baseline|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310798|NCT00215683|P3|Participant Flow|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310799|NCT00215683|P2|Participant Flow|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310800|NCT00215683|P1|Participant Flow|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310801|NCT00215683|O3|Outcome|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310802|NCT00215683|O2|Outcome|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310803|NCT00215683|O1|Outcome|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310804|NCT00215683|O3|Outcome|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310805|NCT00215683|O2|Outcome|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310806|NCT00215683|O1|Outcome|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310807|NCT00215683|E3|Reported Event|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310808|NCT00215683|E2|Reported Event|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310809|NCT00215683|E1|Reported Event|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
310810|NCT00215787|B1|Baseline|Lansoprazole|Lansoprazole 30mg BID for one year
310811|NCT00215787|P1|Participant Flow|Lansoprazole|Lansoprazole 30mg BID for one year
310812|NCT00215787|O1|Outcome|Lansoprazole|Lansoprazole 30mg BID for one year
310813|NCT00215787|E1|Reported Event|Lansoprazole|Lansoprazole 30mg BID for one year
310814|NCT00224120|B3|Baseline|Total|Total of all reporting groups
310815|NCT00224120|B2|Baseline|Placebo|Matching placebo capsule once daily with food
310816|NCT00224120|B1|Baseline|Silodosin|Silodosin 8 mg once daily with food
310817|NCT00224120|P2|Participant Flow|Placebo|Matching placebo capsule once daily with food
310818|NCT00224120|P1|Participant Flow|Silodosin|Silodosin 8 mg once daily with food
310819|NCT00224120|O2|Outcome|Placebo|Matching placebo capsule once daily with food
310820|NCT00224120|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
310821|NCT00224120|O2|Outcome|Placebo|Matching placebo capsule once daily with food
310822|NCT00224120|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
310823|NCT00224120|E2|Reported Event|Placebo|Matching placebo capsule once daily with food
310824|NCT00224120|E1|Reported Event|Silodosin|Silodosin 8 mg once daily with food
310825|NCT00224133|B1|Baseline|8 mg Silodosin Per Day With Food|
310826|NCT00224133|P1|Participant Flow|8 mg Silodosin Per Day With Food|
310827|NCT00224133|O1|Outcome|8 mg Silodosin Per Day With Food|
310828|NCT00224133|E1|Reported Event|8 mg Silodosin Per Day With Food|
310829|NCT00224289|B1|Baseline|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.
Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
310830|NCT00224289|P1|Participant Flow|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.
Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
310831|NCT00224289|O1|Outcome|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.
Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
310832|NCT00224289|O1|Outcome|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.
Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
310833|NCT00224289|E1|Reported Event|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.
Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
310834|NCT00226239|B1|Baseline|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
310835|NCT00226239|P1|Participant Flow|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
310836|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
310837|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
310838|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
310839|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
310840|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
310841|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles
310842|NCT00226239|E1|Reported Event|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
310843|NCT00226577|B1|Baseline|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
310844|NCT00226577|P1|Participant Flow|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
310953|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
310954|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
310845|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
310846|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
310847|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
310848|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
310849|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
310850|NCT00226577|E1|Reported Event|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
310851|NCT00226590|B1|Baseline|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
311020|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
310852|NCT00226590|P1|Participant Flow|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
310853|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
310854|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
310855|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
310856|NCT00226590|O1|Outcome|Induction Therapy|Tolerance of Induction Therapy prior to Chemoradiation
310857|NCT00226590|E1|Reported Event|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
310858|NCT00226655|B1|Baseline|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
310859|NCT00226655|P1|Participant Flow|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
310860|NCT00226655|O1|Outcome|hCRF|hCRF administered 1mg bid subcutaneously
310861|NCT00226655|E1|Reported Event|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
310862|NCT00226811|B1|Baseline|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
310863|NCT00226811|P1|Participant Flow|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
310864|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
310865|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
310866|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
310955|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
310867|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
310868|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
310869|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
310870|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
310871|NCT00226811|E1|Reported Event|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
310872|NCT00227019|B1|Baseline|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
310873|NCT00227019|P1|Participant Flow|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
310893|NCT00227266|O1|Outcome|Cohort 2 Experimental|"Patients in cohort 2 (SMA standers and walkers) will receive VPA + Carnitine treatment for the entire 12 month time period."
311021|NCT00227903|O1|Outcome|Brief Advice|Advice and education
310874|NCT00227019|O1|Outcome|Bevacizumab + Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
310875|NCT00227019|O1|Outcome|Bevacizumab + Pemetrexed|Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
310876|NCT00227019|O1|Outcome|Bevacizumab + Pemetrexed|Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
310877|NCT00227019|E1|Reported Event|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
310878|NCT00227266|B4|Baseline|Total|Total of all reporting groups
310879|NCT00227266|B3|Baseline|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310880|NCT00227266|B2|Baseline|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310881|NCT00227266|B1|Baseline|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
310882|NCT00227266|P3|Participant Flow|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310883|NCT00227266|P2|Participant Flow|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310989|NCT00227903|O1|Outcome|Brief Advice|Advice and education
315868|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
310884|NCT00227266|P1|Participant Flow|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
310885|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310886|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310887|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
310888|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310889|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310890|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
310891|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|
310894|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310895|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310896|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
310897|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310898|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310899|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
310900|NCT00227266|E3|Reported Event|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310901|NCT00227266|E2|Reported Event|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
310902|NCT00227266|E1|Reported Event|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
310903|NCT00227305|B1|Baseline|Quetiapine|Quetiapine 400mg/day to 800mg/day
310904|NCT00227305|P1|Participant Flow|Quetiapine|Quetiapine 400mg/day to 800mg/day
310905|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
310906|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
310907|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
310908|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
310909|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
310910|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
310911|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
310912|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
310913|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
310914|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
310915|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
310916|NCT00227305|E1|Reported Event|Quetiapine|Quetiapine 400mg/day to 800mg/day
310917|NCT00227344|B3|Baseline|Total|Total of all reporting groups
310918|NCT00227344|B2|Baseline|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
310919|NCT00227344|B1|Baseline|Catheter Ablation|Catheter Ablation
310920|NCT00227344|P2|Participant Flow|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
310921|NCT00227344|P1|Participant Flow|Catheter Ablation|Catheter Ablation
310922|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
310923|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
310924|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
310925|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
310926|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
310927|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
310928|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
310929|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
311018|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
310930|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
310931|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
310932|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
310933|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
310934|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
310935|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
310936|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
310937|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
310938|NCT00227344|E2|Reported Event|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
310939|NCT00227344|E1|Reported Event|Catheter Ablation|Catheter Ablation
310940|NCT00227370|B3|Baseline|Total|Total of all reporting groups
310941|NCT00227370|B2|Baseline|Treatment Group|Upon randomisation at 3 months, patients remained on Valganciclovir for 9 additional months.
310942|NCT00227370|B1|Baseline|Placebo Group|Upon randomisation at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis
310943|NCT00227370|P2|Participant Flow|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
310944|NCT00227370|P1|Participant Flow|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis). 3 months of Valganciclovir was the standard of care for CMV prevention at the time of study initiation. This was the prespecified placebo group/intervention arm.
310945|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
310946|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
310947|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
310948|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
310949|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
310950|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
310951|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
310952|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
315869|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
310956|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
310957|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
310958|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
310959|NCT00227370|E2|Reported Event|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
310960|NCT00227370|E1|Reported Event|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
310961|NCT00227539|B1|Baseline|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin
pemetrexed disodium
adjuvant therapy
therapeutic conventional surgery
fludeoxyglucose F 18"
310962|NCT00227539|P1|Participant Flow|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin
pemetrexed disodium
adjuvant therapy
therapeutic conventional surgery
fludeoxyglucose F 18"
310963|NCT00227539|O1|Outcome|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin
pemetrexed disodium
adjuvant therapy
therapeutic conventional surgery
fludeoxyglucose F 18"
310964|NCT00227539|O1|Outcome|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin
pemetrexed disodium
adjuvant therapy
therapeutic conventional surgery
fludeoxyglucose F 18"
310965|NCT00227539|O1|Outcome|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin
pemetrexed disodium
adjuvant therapy
therapeutic conventional surgery
fludeoxyglucose F 18"
310966|NCT00227539|E1|Reported Event|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin
pemetrexed disodium
adjuvant therapy
therapeutic conventional surgery
fludeoxyglucose F 18"
310967|NCT00227591|B1|Baseline|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
310968|NCT00227591|P1|Participant Flow|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
310969|NCT00227591|O1|Outcome|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
310970|NCT00227591|E1|Reported Event|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
310971|NCT00227721|B1|Baseline|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
310972|NCT00227721|P1|Participant Flow|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
310973|NCT00227721|O1|Outcome|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
310974|NCT00227721|E1|Reported Event|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
310975|NCT00227760|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib Maleate: Given PO
Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
310976|NCT00227760|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib Maleate: Given PO
Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
310977|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib Maleate: Given PO
Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
310978|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib Maleate: Given PO
Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
310979|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib Maleate: Given PO
Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
310980|NCT00227760|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib Maleate: Given PO
Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies"
310981|NCT00227903|B3|Baseline|Total|Total of all reporting groups
310982|NCT00227903|B2|Baseline|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
310983|NCT00227903|B1|Baseline|Brief Advice|Advice and education
310984|NCT00227903|P2|Participant Flow|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
310985|NCT00227903|P1|Participant Flow|Brief Advice|Advice and education
310986|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
310987|NCT00227903|O1|Outcome|Brief Advice|Advice and education
310988|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
310990|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
310991|NCT00227903|O1|Outcome|Brief Advice|Advice and education
310992|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
310993|NCT00227903|O1|Outcome|Brief Advice|Advice and education
310994|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
310995|NCT00227903|O1|Outcome|Brief Advice|Advice and education
310996|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
310997|NCT00227903|O1|Outcome|Brief Advice|Advice and education
310998|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
310999|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311000|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311001|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311002|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311003|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311004|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311005|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311006|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311007|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311008|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311009|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311010|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311011|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311012|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311013|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311014|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311015|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311016|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311017|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311019|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311022|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311023|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311024|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311025|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311026|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311027|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311028|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311029|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311030|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311031|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311032|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311033|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311034|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311035|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311036|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311037|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311038|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311039|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311040|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311041|NCT00227903|O1|Outcome|Brief Advice|Advice and education
311042|NCT00227903|E2|Reported Event|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
311043|NCT00227903|E1|Reported Event|Brief Advice|Advice and education
311044|NCT00227994|B3|Baseline|Total|Total of all reporting groups
311045|NCT00227994|B2|Baseline|Donepezil|"Donepezil for 12 weeks
Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
311046|NCT00227994|B1|Baseline|Galantamine|"Galantamine for 12 weeks
Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
311047|NCT00227994|P2|Participant Flow|Donepezil|"Donepezil for 12 weeks
Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
311048|NCT00227994|P1|Participant Flow|Galantamine|"Galantamine for 12 weeks
Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
311049|NCT00227994|O2|Outcome|Donepezil|"Donepezil for 12 weeks
Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
311050|NCT00227994|O1|Outcome|Galantamine|"Galantamine for 12 weeks
Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
311051|NCT00227994|O2|Outcome|Donepezil|"Donepezil for 12 weeks
Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
311052|NCT00227994|O1|Outcome|Galantamine|"Galantamine for 12 weeks
Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
311281|NCT00220727|B2|Baseline|IGIV-C, 10% - 0.14/0.08 mL/kg/Min|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
311053|NCT00227994|E2|Reported Event|Donepezil|"Donepezil for 12 weeks
Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
311054|NCT00227994|E1|Reported Event|Galantamine|"Galantamine for 12 weeks
Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
311055|NCT00228384|B3|Baseline|Total|Total of all reporting groups
311056|NCT00228384|B2|Baseline|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311057|NCT00228384|B1|Baseline|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311058|NCT00228384|P2|Participant Flow|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311059|NCT00228384|P1|Participant Flow|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311060|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311061|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311062|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311063|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311064|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311065|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311066|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311067|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311068|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311069|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311070|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311071|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311072|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311073|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311074|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311075|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311076|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311077|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311078|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311079|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311080|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311081|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311082|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311083|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311084|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311085|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311086|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311087|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311088|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311089|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311090|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311091|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311092|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
311093|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
311094|NCT00228384|E2|Reported Event|Bare Nitinol Stent|Bare Nitinol Stent
311095|NCT00228384|E1|Reported Event|GORE VIABAHN Endoprosthesis|GORE VIABAHN Endoprosthesis
311096|NCT00228553|B1|Baseline|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
312131|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
311097|NCT00228553|P1|Participant Flow|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
311098|NCT00228553|O1|Outcome|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
311099|NCT00228553|E1|Reported Event|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
311100|NCT00228566|B1|Baseline|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
311101|NCT00228566|P1|Participant Flow|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
311102|NCT00228566|O1|Outcome|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
311103|NCT00228566|E1|Reported Event|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
311104|NCT00219141|B4|Baseline|Total|Total of all reporting groups
311105|NCT00219141|B3|Baseline|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311106|NCT00219141|B2|Baseline|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311107|NCT00219141|B1|Baseline|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311108|NCT00219141|P3|Participant Flow|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311109|NCT00219141|P2|Participant Flow|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311110|NCT00219141|P1|Participant Flow|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311311|NCT00220740|E1|Reported Event|IGIV-C|"2 g/kg loading dose, followed by 1 g/kg maintenance dose.
A total of 113 subjects were exposed to IGIV-C across all three treatments/periods."
311111|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311112|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311113|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311114|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311115|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311116|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311117|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311118|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311119|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311120|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311121|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311122|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311123|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311124|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311125|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311126|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311127|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311128|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311129|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311130|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311131|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311132|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311133|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311134|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311135|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311136|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311137|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311138|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311139|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311140|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311141|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311142|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311143|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311144|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311145|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311146|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311147|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311148|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311149|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311150|NCT00219141|E3|Reported Event|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
311151|NCT00219141|E2|Reported Event|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
311152|NCT00219141|E1|Reported Event|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
311153|NCT00219284|B3|Baseline|Total|Total of all reporting groups
311154|NCT00219284|B2|Baseline|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311194|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311155|NCT00219284|B1|Baseline|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311156|NCT00219284|P2|Participant Flow|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311157|NCT00219284|P1|Participant Flow|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311158|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311159|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311312|NCT00220779|B4|Baseline|Total|Total of all reporting groups
311313|NCT00220779|B3|Baseline|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
311160|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311161|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311162|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311163|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311164|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311282|NCT00220727|B1|Baseline|IGIV-C, 10% - 0.08/0.14 mL/kg/Min|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
312132|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
311165|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311166|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311167|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311168|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311169|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311185|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311314|NCT00220779|B2|Baseline|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
311170|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311171|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311172|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311173|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311174|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311175|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311176|NCT00219284|E2|Reported Event|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311177|NCT00219284|E1|Reported Event|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
311178|NCT00219349|B1|Baseline|Cognitive-behavioral Therapy|14 weekly sessions of individual cognitive-behavioral therapy
311179|NCT00219349|P1|Participant Flow|Cognitive-behavioral Therapy|14 weekly sessions of individual cognitive-behavioral therapy
311180|NCT00219349|O1|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
311181|NCT00219349|E1|Reported Event|Group 1|all subject entered
311182|NCT00219544|B1|Baseline|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311183|NCT00219544|P2|Participant Flow|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311184|NCT00219544|P1|Participant Flow|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311315|NCT00220779|B1|Baseline|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
311186|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311187|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311188|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311189|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311190|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311191|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311192|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311193|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311195|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311196|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311197|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311198|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311199|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311200|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311201|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
311202|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311203|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311204|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311262|NCT00220701|B2|Baseline|Placebo|"inactive comparator
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311205|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311206|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311207|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311208|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
311209|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
311210|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
311211|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311212|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311213|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311214|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311215|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
311278|NCT00220701|E2|Reported Event|Placebo|"inactive comparator
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311461|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311216|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311217|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
311218|NCT00219544|E3|Reported Event|Placebo Double-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
311219|NCT00219544|E2|Reported Event|Pregabalin Double-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatent phase.
311220|NCT00219544|E1|Reported Event|Pregabalin Single-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
311221|NCT00219557|B4|Baseline|Total|Total of all reporting groups
311222|NCT00219557|B3|Baseline|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311223|NCT00219557|B2|Baseline|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311224|NCT00219557|B1|Baseline|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311225|NCT00219557|P3|Participant Flow|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311226|NCT00219557|P2|Participant Flow|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311227|NCT00219557|P1|Participant Flow|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311228|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311310|NCT00220740|E2|Reported Event|Placebo|".1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose.
A total of 95 subjects were exposed to Placebo across all three treatments/periods."
311229|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311230|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311231|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311232|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311233|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311234|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311235|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311236|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311237|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311238|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311239|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311240|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311241|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311242|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311279|NCT00220701|E1|Reported Event|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311243|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311244|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311245|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311246|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311247|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311248|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311249|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311250|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311251|NCT00219557|E3|Reported Event|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311252|NCT00219557|E2|Reported Event|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally twice daily (BID) from Day 1 of Cycle 1 (28 days) and all subsequent cycles (28 days). Gemcitabine 1000 mg/m^2 30-minute infusion on Day 1, 8 and 15 of each cycle.
311253|NCT00219557|E1|Reported Event|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
311254|NCT00220636|B1|Baseline|Aripiprazole|aripiprazole augmentation treatment
311255|NCT00220636|P1|Participant Flow|Aripiprazole|aripiprazole augmentation treatment
311256|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
311257|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
311258|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment for treatment resistant depression
311259|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
311260|NCT00220636|E1|Reported Event|Aripiprazole|aripiprazole augmentation treatment
311261|NCT00220701|B3|Baseline|Total|Total of all reporting groups
311263|NCT00220701|B1|Baseline|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311264|NCT00220701|P2|Participant Flow|Placebo|"inactive comparator
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311265|NCT00220701|P1|Participant Flow|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311266|NCT00220701|O2|Outcome|Placebo|"inactive comparator
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311267|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311268|NCT00220701|O2|Outcome|Placebo|"inactive comparator
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311269|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311270|NCT00220701|O2|Outcome|Placebo|"inactive comparator
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311271|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311272|NCT00220701|O2|Outcome|Placebo|"inactive comparator
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311273|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311274|NCT00220701|O2|Outcome|Placebo|"inactive comparator
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311275|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311276|NCT00220701|O2|Outcome|Placebo|"inactive comparator
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311277|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
311280|NCT00220727|B3|Baseline|Total|Total of all reporting groups
311283|NCT00220727|P2|Participant Flow|IGIV-C, 10% - 0.14/0.08 mL/kg/Min|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
311284|NCT00220727|P1|Participant Flow|IGIV-C, 10% - 0.08/0.14 mL/kg/Min|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
311285|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
311286|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
311287|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
311288|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
311289|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
311290|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
311291|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
311292|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
311293|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
311294|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
311295|NCT00220727|E2|Reported Event|IGIV-C, 10% - 0.14 mL/kg/Min|IGIV-C (0.14 mL/kg/min);
311296|NCT00220727|E1|Reported Event|IGIV-C, 10% - 0.08 mL/kg/Min|IGIV-C (0.08 mL/kg/min);
311297|NCT00220740|B3|Baseline|Total|Total of all reporting groups
311298|NCT00220740|B2|Baseline|Placebo|.1% albumin, 2 g/kg loading dose, followed by 1 g/kg maintenance dose
311299|NCT00220740|B1|Baseline|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
311300|NCT00220740|P2|Participant Flow|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
311301|NCT00220740|P1|Participant Flow|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
311302|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
311303|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
311304|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
311305|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
311306|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
311307|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
311308|NCT00220740|O2|Outcome|Placebo|
311309|NCT00220740|O1|Outcome|IGIV-C|
311316|NCT00220779|P3|Participant Flow|Placebo (0.1% Albumin) 4 mL/kg Body Weight/Infusion|Immune globulin (intravenous) (IGIV)
311317|NCT00220779|P2|Participant Flow|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg Body Weight)|Immune globulin (intravenous) (IGIV)
311318|NCT00220779|P1|Participant Flow|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg Body Weight)|Immune globulin (intravenous) (IGIV)
311319|NCT00220779|O3|Outcome|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
311320|NCT00220779|O2|Outcome|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
311321|NCT00220779|O1|Outcome|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
311322|NCT00220779|E3|Reported Event|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
311323|NCT00220779|E2|Reported Event|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
311324|NCT00220779|E1|Reported Event|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
311325|NCT00220805|B3|Baseline|Total|Total of all reporting groups
311326|NCT00220805|B2|Baseline|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
311327|NCT00220805|B1|Baseline|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
311328|NCT00220805|P2|Participant Flow|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
311329|NCT00220805|P1|Participant Flow|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
311330|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
311331|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
311332|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
311333|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
311334|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
311335|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
311336|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
311337|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
311338|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
311339|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
311340|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
311341|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
311342|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
311343|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
311344|NCT00220805|E2|Reported Event|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
311345|NCT00220805|E1|Reported Event|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
311346|NCT00220961|B3|Baseline|Total|Total of all reporting groups
311347|NCT00220961|B2|Baseline|Pioglitazone|"Pioglitazone tablet similar to placebo tablet
Pioglitazone: Pioglitazone tablets"
311348|NCT00220961|B1|Baseline|Placebo|"Placebo tablet similar to pioglitazone tablet
Placebo: Placebo tablets similar to pioglitazone tablets"
311349|NCT00220961|P2|Participant Flow|Pioglitazone|"Pioglitazone tablet similar to placebo tablet
Pioglitazone: Pioglitazone tablets - 45mg/day tablet"
315870|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
311350|NCT00220961|P1|Participant Flow|Placebo|"Placebo tablet similar to pioglitazone tablet
Placebo: Placebo tablets similar to pioglitazone tablets - 1 tablet/day"
311351|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet
Pioglitazone: Pioglitazone tablets"
311352|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet
Placebo: Placebo tablets similar to pioglitazone tablets"
311353|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet
Pioglitazone: Pioglitazone tablets"
311354|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet
Placebo: Placebo tablets similar to pioglitazone tablets"
311355|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet
Pioglitazone: Pioglitazone tablets"
311356|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet
Placebo: Placebo tablets similar to pioglitazone tablets"
311357|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet
Pioglitazone: Pioglitazone tablets"
311358|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet
Placebo: Placebo tablets similar to pioglitazone tablets"
311359|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet
Pioglitazone: Pioglitazone tablets"
311360|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet
Placebo: Placebo tablets similar to pioglitazone tablets"
311361|NCT00220961|E2|Reported Event|Pioglitazone|"Pioglitazone tablet similar to placebo tablet
Pioglitazone: Pioglitazone tablets"
311362|NCT00220961|E1|Reported Event|Placebo|"Placebo tablet similar to pioglitazone tablet
Placebo: Placebo tablets similar to pioglitazone tablets"
311363|NCT00221195|B3|Baseline|Total|Total of all reporting groups
311364|NCT00221195|B2|Baseline|Prophylaxis First|Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
311365|NCT00221195|B1|Baseline|On-demand First|Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
311366|NCT00221195|P2|Participant Flow|Prophylaxis First|Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
311367|NCT00221195|P1|Participant Flow|On-demand First|Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
311368|NCT00221195|O2|Outcome|Bleeds During the Prophylaxis Period|
311369|NCT00221195|O1|Outcome|Bleeds During the On-demand Period|
311370|NCT00221195|E3|Reported Event|Washout Period|
311371|NCT00221195|E2|Reported Event|Prophylaxis Period|
311372|NCT00221195|E1|Reported Event|On-demand Period|
311373|NCT00221299|B4|Baseline|Total|Total of all reporting groups
311374|NCT00221299|B3|Baseline|Parathyroid Hormone Placebo Injections and Risedronate Tables|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year
Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
311375|NCT00221299|B2|Baseline|Parathyroid Hormone Injections and Risedronate Tablets|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year
Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
311376|NCT00221299|B1|Baseline|Parathyroid Hormone Injections and Risedronate Placebo Tablets|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
311377|NCT00221299|P4|Participant Flow|Group3-rhPTH-Placebo&Risedronate|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), placebo SC injections of normal saline daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.
Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
311378|NCT00221299|P3|Participant Flow|Group2-rhPTH&Risedronate|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.
Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
311379|NCT00221299|P2|Participant Flow|Group1b-rhPTH&RisendronatePlacebo|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - continue on risedronate placebo tablets for second year.
Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
311380|NCT00221299|P1|Participant Flow|Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2)|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year.
Risedronate: One 35mg tab of risedronate/placebo taken once a week for year 1. One 35mg tab of risedronate taken once a week for year 2.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
311381|NCT00221299|O3|Outcome|Parathyroid Hormone Placebo&Risedronate|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year
Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
311462|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311463|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311382|NCT00221299|O2|Outcome|Parathyroid Hormone&Risedronate|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year
Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
311383|NCT00221299|O1|Outcome|Parathyroid Hormone&Risedronate Placebo|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
311384|NCT00221299|E3|Reported Event|Parathyroid Hormone Placebo Injections and Risedronate Tablets|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year
Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
311385|NCT00221299|E2|Reported Event|Parthyroid Hormone Injections and Risedronte Tablets|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year
Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
311386|NCT00221299|E1|Reported Event|Parathyroid Hormone Injections and Risedronate Placebo Tablets|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
311387|NCT00228813|B1|Baseline|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
311388|NCT00228813|P1|Participant Flow|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
311389|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
311390|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
311391|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
328538|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
311392|NCT00228813|E1|Reported Event|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
311393|NCT00228917|B5|Baseline|Total|Total of all reporting groups
311394|NCT00228917|B4|Baseline|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311395|NCT00228917|B3|Baseline|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311396|NCT00228917|B2|Baseline|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311397|NCT00228917|B1|Baseline|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
311398|NCT00228917|P4|Participant Flow|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311399|NCT00228917|P3|Participant Flow|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311400|NCT00228917|P2|Participant Flow|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311401|NCT00228917|P1|Participant Flow|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
311402|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311403|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311404|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311405|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
311491|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311492|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311406|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311407|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311408|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311409|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
311410|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311411|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311464|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311465|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311466|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
315871|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
311412|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311413|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
311414|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311415|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311416|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311417|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
311418|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311493|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311419|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311420|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311421|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
311422|NCT00228917|E4|Reported Event|TRITANRIX-HEPB/ TRITANRIX-HEPB GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311423|NCT00228917|E3|Reported Event|TRITANRIX-HEPB/ HIBERIX GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311467|NCT00229658|E2|Reported Event|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311468|NCT00229658|E1|Reported Event|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311469|NCT00229723|B8|Baseline|Total|Total of all reporting groups
311470|NCT00229723|B7|Baseline|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311424|NCT00228917|E2|Reported Event|HIBERIX/TRITANRIX-HEPB GROUP|Subjects vaccinated with 3 doses of Mencevax™ ACW vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311425|NCT00228917|E1|Reported Event|HIBERIX/ HIBERIX GROUP|Subjects vaccinated with 3 doses of Mencevax™ ACW vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
311426|NCT00228943|B1|Baseline|Entire Sample|"Consented subjects in the entire sample were randomized to one of two groups for the cross-over design study. One group of subjects received a full-strength tryptophan depletion drink during week 1 followed by a half-strength (control) drink week 2. The other group of subjects received a half-strength tryptophan depletion (control) drink during week 1 followed by a full-strength drink week 2.
The final analysis combined groups to compare full strength versus control."
311427|NCT00228943|P1|Participant Flow|Full Strength Acute Tryptophan Depletion and Control|Subjects were randomized to receive both a full-strength acute tryptophan depletion drink and half-strength tryptophan depletion drink (control). Some participants received the full-strength drink first for week 1 and then crossed-over to the half-strength (control) drink for week 2; the other participants received the half-strength (control) drink for week 1 and then crossed over to the full-strength drink for week 2.
311428|NCT00228943|O2|Outcome|Half-Strength Tryptophan Depletion - Control|
311429|NCT00228943|O1|Outcome|Full Strength Acute Tryptophan Depletion|
311430|NCT00228943|O2|Outcome|Half-Strength Tryptophan Depletion - Control|
311431|NCT00228943|O1|Outcome|Full Strength Acute Tryptophan Depletion|
311432|NCT00228943|E2|Reported Event|Half-Strength Tryptophan Depletion - Control|No adverse events
311433|NCT00228943|E1|Reported Event|Full Strength Acute Tryptophan Depletion|No adverse events
311434|NCT00229619|B1|Baseline|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
311435|NCT00229619|P1|Participant Flow|Rituximab Treated Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
311436|NCT00229619|O1|Outcome|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
311494|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311495|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311437|NCT00229619|E1|Reported Event|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
311438|NCT00229658|B3|Baseline|Total|Total of all reporting groups
311439|NCT00229658|B2|Baseline|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311440|NCT00229658|B1|Baseline|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311441|NCT00229658|P2|Participant Flow|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311442|NCT00229658|P1|Participant Flow|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311443|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311444|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311445|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311446|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311447|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311448|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311449|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311450|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311451|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311452|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311453|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311454|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311455|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311456|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311457|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311458|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311459|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
311460|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
311471|NCT00229723|B6|Baseline|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311472|NCT00229723|B5|Baseline|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311473|NCT00229723|B4|Baseline|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311474|NCT00229723|B3|Baseline|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311475|NCT00229723|B2|Baseline|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311476|NCT00229723|B1|Baseline|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311477|NCT00229723|P7|Participant Flow|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311478|NCT00229723|P6|Participant Flow|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311479|NCT00229723|P5|Participant Flow|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311480|NCT00229723|P4|Participant Flow|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311481|NCT00229723|P3|Participant Flow|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311482|NCT00229723|P2|Participant Flow|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311483|NCT00229723|P1|Participant Flow|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311484|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311485|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311486|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311487|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311488|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311489|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311490|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311567|NCT00230009|B2|Baseline|Brief Intervention Session|
311496|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311497|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311498|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311499|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311500|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311501|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311502|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311503|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311504|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311505|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311506|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311507|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311508|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311509|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311510|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311511|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311512|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311513|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311514|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311515|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311516|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311517|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311518|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311519|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311520|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311521|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311522|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311523|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311524|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311525|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311526|NCT00229723|E7|Reported Event|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311527|NCT00229723|E6|Reported Event|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311528|NCT00229723|E5|Reported Event|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
311529|NCT00229723|E4|Reported Event|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
311530|NCT00229723|E3|Reported Event|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311531|NCT00229723|E2|Reported Event|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311532|NCT00229723|E1|Reported Event|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
311533|NCT00229931|B3|Baseline|Total|Total of all reporting groups
311534|NCT00229931|B2|Baseline|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.
Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
311535|NCT00229931|B1|Baseline|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.
laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
311568|NCT00230009|B1|Baseline|Assessment Only|
311694|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
311536|NCT00229931|P2|Participant Flow|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.
Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
311537|NCT00229931|P1|Participant Flow|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.
laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
311538|NCT00229931|O2|Outcome|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.
Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
311539|NCT00229931|O1|Outcome|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.
laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
311540|NCT00229931|O2|Outcome|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.
Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
311541|NCT00229931|O1|Outcome|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.
laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
311542|NCT00229931|E2|Reported Event|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.
Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
311543|NCT00229931|E1|Reported Event|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.
laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
311544|NCT00229957|B3|Baseline|Total|Total of all reporting groups
311545|NCT00229957|B2|Baseline|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
311546|NCT00229957|B1|Baseline|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
311547|NCT00229957|P2|Participant Flow|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
311548|NCT00229957|P1|Participant Flow|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
311549|NCT00229957|O2|Outcome|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
311550|NCT00229957|O1|Outcome|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
311551|NCT00229957|E2|Reported Event|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
311552|NCT00229957|E1|Reported Event|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
311553|NCT00229970|B4|Baseline|Total|Total of all reporting groups
311554|NCT00229970|B3|Baseline|Placebo|Placebo Intravenous Administration
311555|NCT00229970|B2|Baseline|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
311556|NCT00229970|B1|Baseline|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
311557|NCT00229970|P3|Participant Flow|Placebo|Placebo Intravenous Administration
311558|NCT00229970|P2|Participant Flow|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
311559|NCT00229970|P1|Participant Flow|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
311560|NCT00229970|O3|Outcome|Placebo|Placebo Intravenous Administration
311561|NCT00229970|O2|Outcome|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
311562|NCT00229970|O1|Outcome|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
311563|NCT00229970|E3|Reported Event|Placebo|Placebo Intravenous Administration
311564|NCT00229970|E2|Reported Event|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
311565|NCT00229970|E1|Reported Event|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
311566|NCT00230009|B3|Baseline|Total|Total of all reporting groups
311569|NCT00230009|P2|Participant Flow|Brief Intervention Session|Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data. Plus brief therapist-delivered motivational intervention, which was tied to the results of the A-CASI assessment (results from which were viewable immediately by the therapist).
311570|NCT00230009|P1|Participant Flow|Assessment Only|Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data only.
311571|NCT00230009|O2|Outcome|Brief Intervention Session|
311572|NCT00230009|O1|Outcome|Assessment Only|
311573|NCT00230009|O2|Outcome|Brief Intervention Session|
311574|NCT00230009|O1|Outcome|Assessment Only|
311575|NCT00230009|O2|Outcome|Brief Intervention Session|
311576|NCT00230009|O1|Outcome|Assessment Only|
311577|NCT00230009|O2|Outcome|Brief Intervention Session|
311578|NCT00230009|O1|Outcome|Assessment Only|
311579|NCT00230009|O2|Outcome|Brief Intervention Session|
311580|NCT00230009|O1|Outcome|Assessment Only|
311581|NCT00230009|E2|Reported Event|Brief Intervention Session|
311582|NCT00230009|E1|Reported Event|Assessment Only|
311583|NCT00230022|B3|Baseline|Total|Total of all reporting groups
311584|NCT00230022|B2|Baseline|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
311585|NCT00230022|B1|Baseline|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
311586|NCT00230022|P2|Participant Flow|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
311587|NCT00230022|P1|Participant Flow|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
311588|NCT00230022|O2|Outcome|Assessment Only|Only assessment measures with no subsequent intervention.
311589|NCT00230022|O1|Outcome|Brief Computer-delivered Motivational Intervention|A brief assessment, plus a brief (20-minute) motivational intervention delivered solely by computer. The software was synchronously interactive and followed a traditional motivational interviewing approach.
311590|NCT00230022|E2|Reported Event|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
311591|NCT00230022|E1|Reported Event|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
311592|NCT00230048|B3|Baseline|Total|Total of all reporting groups
311593|NCT00230048|B2|Baseline|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
311594|NCT00230048|B1|Baseline|Assessment Only|This arm answered questions only, but received no intervention.
311595|NCT00230048|P2|Participant Flow|Brief Intervention|Brief computer-delivered intervention following motivational approach, adapted from Motivational Interviewing: Decisional balance, normed feedback, and optional goal-setting.
311596|NCT00230048|P1|Participant Flow|Assessment Only|This arm answered questions only, but received no intervention.
311597|NCT00230048|O2|Outcome|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
311598|NCT00230048|O1|Outcome|Assessment Only|This arm answered questions only, but received no intervention.
311599|NCT00230048|O2|Outcome|Brief Intervention|Assessment plus 20-minute interactive session with computer, designed to be maximally similar to a therapist-delivered motivational session.
311600|NCT00230048|O1|Outcome|Assessment Only|Assessment only, via computer.
311601|NCT00230048|E2|Reported Event|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
311602|NCT00230048|E1|Reported Event|Assessment Only|This arm answered questions only, but received no intervention.
311603|NCT00230100|B3|Baseline|Total|Total of all reporting groups
311604|NCT00230100|B2|Baseline|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
311605|NCT00230100|B1|Baseline|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
311606|NCT00230100|P2|Participant Flow|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
311650|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
311651|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
311652|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
311607|NCT00230100|P1|Participant Flow|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
311608|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
311609|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
311610|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
311611|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
311677|NCT00230802|B2|Baseline|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
311612|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
311613|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
311614|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
311615|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
311653|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
311654|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
328539|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
311616|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
311617|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
311618|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
311619|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
311620|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
311678|NCT00230802|B1|Baseline|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
311621|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
311622|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
311623|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
311624|NCT00230100|E2|Reported Event|Mixed-gender Group Drug Counseling|The GDC is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance dependence; 3) increase patients’ self-awareness of the problems that substance dependence has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse.
311655|NCT00230178|E3|Reported Event|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
311656|NCT00230178|E2|Reported Event|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
311657|NCT00230178|E1|Reported Event|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
311695|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
312915|NCT00237185|P2|Participant Flow|Imatinib Mesylate 600 mg|imatinib mesylate 600 mg once daily
311625|NCT00230100|E1|Reported Event|Women's Recovery Group|The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (b) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (c) help participants with skills and strategies useful in preventing relapse and promote recovery.
311626|NCT00230126|B3|Baseline|Total|Total of all reporting groups
311627|NCT00230126|B2|Baseline|Arm B: Cycle 1 - 150-200 mg/Day Depending on Body Weight|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.
Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311628|NCT00230126|B1|Baseline|Arm A: 150 mg/Day|"150 mg/day
erlotinib: Arm A: 150 mg/day Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311629|NCT00230126|P2|Participant Flow|Arm B: Erlotinib 150 to 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.
erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311630|NCT00230126|P1|Participant Flow|Arm A: Erlotinib 150 mg/Day|"150 mg/day cycles 1 - 3
erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311631|NCT00230126|O2|Outcome|B Erlotinib Cycle 1 Dose Modified According to Weight|"erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.
erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311632|NCT00230126|O1|Outcome|A Erlotinib 150 mg/Day Cycles 1 - 3|"erlotinib 150 mg/day cycles 1 - 3
erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311633|NCT00230126|O2|Outcome|B Erlotinib Cycle 1 Dose Modified According to Weight|"erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.
erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311634|NCT00230126|O1|Outcome|A Erlotinib 150 mg/Day Cycles 1 - 3|"erlotinib 150 mg/day cycles 1 - 3
erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311635|NCT00230126|O2|Outcome|Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.
erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311636|NCT00230126|O1|Outcome|Erlotinib: Arm A: 150 mg/Day Cycles 1 - 3.|"150 mg/day cycles 1 - 3
erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311637|NCT00230126|E2|Reported Event|Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.
erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311638|NCT00230126|E1|Reported Event|Arm A: 150 mg/Day Cycles 1 - 3|"150 mg/day cycles 1 - 3
erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
311639|NCT00230178|B4|Baseline|Total|Total of all reporting groups
311640|NCT00230178|B3|Baseline|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
311641|NCT00230178|B2|Baseline|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
311642|NCT00230178|B1|Baseline|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
311643|NCT00230178|P3|Participant Flow|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
311644|NCT00230178|P2|Participant Flow|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
311645|NCT00230178|P1|Participant Flow|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
311646|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
311647|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
311648|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
311649|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
312916|NCT00237185|P1|Participant Flow|Imatinib Mesylate 400 mg|imatinib mesylate 400 mg once daily
311658|NCT00230282|B1|Baseline|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
311659|NCT00230282|P1|Participant Flow|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
311660|NCT00230282|O1|Outcome|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
311661|NCT00230282|O1|Outcome|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
311662|NCT00230282|E1|Reported Event|Fludarabine, Cytoxan, Then Alemtuzumab|"Fludarabine and cyclophosphamide days 1 to 3 for six 28-day cycles. Minimal residual disease positive responders continued on-treatment to receive alemtuzumab 30 mg weekly. MRD negative responders were observed.
Alemtuzumab: 3 to 30 mg, IV
Fludarabine: [(2R,3R,4S,5R)-5-(6-amino-2-fluoro-purin-9-yl)- 3,4-dihydroxy-oxolan-2-yl]methoxyphosphonic acid
Cytoxan: (RS)-N,N-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide"
311663|NCT00230737|B4|Baseline|Total|Total of all reporting groups
311664|NCT00230737|B3|Baseline|C: Control|Placebo
311665|NCT00230737|B2|Baseline|B: High Dose|Melatonin 4.0 mg
311666|NCT00230737|B1|Baseline|A: Low Dose|Melatonin 0.4 mg
311667|NCT00230737|P3|Participant Flow|C: Control|Placebo
311668|NCT00230737|P2|Participant Flow|B: High Dose|Melatonin 4.0 mg
311669|NCT00230737|P1|Participant Flow|A: Low Dose|Melatonin 0.4 mg
311670|NCT00230737|O3|Outcome|C: Control|Placebo
311671|NCT00230737|O2|Outcome|B: High Dose|Melatonin 4.0 mg
311672|NCT00230737|O1|Outcome|A: Low Dose|Melatonin 0.4 mg
311673|NCT00230737|E3|Reported Event|C: Control|Placebo
311674|NCT00230737|E2|Reported Event|B: High Dose|Melatonin 4.0 mg
311675|NCT00230737|E1|Reported Event|A: Low Dose|Melatonin 0.4 mg
311676|NCT00230802|B3|Baseline|Total|Total of all reporting groups
311679|NCT00230802|P2|Participant Flow|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
311680|NCT00230802|P1|Participant Flow|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
311681|NCT00230802|O2|Outcome|3 Tablet Increase|"Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.
levothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week."
311682|NCT00230802|O1|Outcome|2 Tablet Increase|"Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.
levothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week"
311683|NCT00230802|O2|Outcome|3 Tablet Increase|"Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.
levothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week."
311684|NCT00230802|O1|Outcome|2 Tablet Increase|"Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.
levothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week"
311685|NCT00230802|O2|Outcome|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
311686|NCT00230802|O1|Outcome|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
311687|NCT00230802|E2|Reported Event|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
311688|NCT00230802|E1|Reported Event|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
311689|NCT00230971|B3|Baseline|Total|Total of all reporting groups
311690|NCT00230971|B2|Baseline|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
311691|NCT00230971|B1|Baseline|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
311692|NCT00230971|P2|Participant Flow|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
311693|NCT00230971|P1|Participant Flow|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
311696|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
311697|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
311698|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
311699|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
311700|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
311701|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
311702|NCT00230971|E2|Reported Event|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
311703|NCT00230971|E1|Reported Event|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
311704|NCT00231062|B1|Baseline|Balloon Dilation of Sinus Ostia|
311705|NCT00231062|P1|Participant Flow|Balloon Dilation of Sinus Ostia|
311706|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
311707|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
311708|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
311709|NCT00231062|E1|Reported Event|Balloon Dilation of Sinus Ostia|
311710|NCT00231114|B3|Baseline|Total|Total of all reporting groups
311711|NCT00231114|B2|Baseline|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311712|NCT00231114|B1|Baseline|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311713|NCT00231114|P2|Participant Flow|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311714|NCT00231114|P1|Participant Flow|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311715|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311716|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311717|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311718|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311719|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311720|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311721|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311722|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311723|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311724|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311725|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311726|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311727|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311728|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311729|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311730|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311731|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311732|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311733|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311734|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311735|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311736|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311737|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311738|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311739|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311740|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311741|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311742|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311743|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311744|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
311745|NCT00231114|E4|Reported Event|Sham (Post-Treatment Period)|Six weeks after the last bronchoscopy session until 12 Months. Sham treatment.
311746|NCT00231114|E3|Reported Event|Alair (Post-Treatment Period)|Six weeks after the last bronchoscopy session until 12 Months. Airways treated with the Alair System.
312917|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
311747|NCT00231114|E2|Reported Event|Sham (Treatment Period)|Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Sham treatment.
311748|NCT00231114|E1|Reported Event|Alair (Treatment Period)|Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Airways treated with the Alair System.
311749|NCT00231153|B3|Baseline|Total|Total of all reporting groups
311750|NCT00231153|B2|Baseline|Povidone-Iodine|
311751|NCT00231153|B1|Baseline|Omiganan 1% Gel|
311752|NCT00231153|P2|Participant Flow|Povidone-Iodine|"All treated patients: Properly consented patients who received 1 or more doses of Povidone-Iodine with any post baseline observations (Primary Safety Population).
Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication)."
311753|NCT00231153|P1|Participant Flow|Omiganan 1% Gel|"All treated patients: Properly consented patients who received 1 or more doses of omiganan 1% gel with any post baseline observations (Primary Safety Population).
Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication)."
311754|NCT00231153|O2|Outcome|Povidone-Iodine|
311755|NCT00231153|O1|Outcome|Omiganan 1% Gel|
311756|NCT00231153|O2|Outcome|Povidone-Iodine|
311757|NCT00231153|O1|Outcome|Omiganan 1% Gel|
311758|NCT00231153|O2|Outcome|Povidone-Iodine|
311759|NCT00231153|O1|Outcome|Omiganan 1% Gel|
311760|NCT00231179|B3|Baseline|Total|Total of all reporting groups
311761|NCT00231179|B2|Baseline|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
311762|NCT00231179|B1|Baseline|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
311763|NCT00231179|P2|Participant Flow|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
311764|NCT00231179|P1|Participant Flow|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
311765|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
311766|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
311767|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
311768|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
311769|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
311770|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
311771|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
311772|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
311773|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
311774|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
311775|NCT00231179|E2|Reported Event|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
311776|NCT00231179|E1|Reported Event|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
311777|NCT00231283|B1|Baseline|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
311778|NCT00231283|P1|Participant Flow|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
311779|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
311780|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
311781|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
311782|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
311783|NCT00231283|E1|Reported Event|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
311784|NCT00231309|B1|Baseline|Single Arm|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
311785|NCT00231309|P1|Participant Flow|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
311786|NCT00231309|O1|Outcome|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
311787|NCT00231309|O1|Outcome|Granulocyte-stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
311788|NCT00231309|E1|Reported Event|Single Arm|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
311789|NCT00231465|B1|Baseline|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.
docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
311790|NCT00231465|P1|Participant Flow|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|Eligible patients were treated with docetaxel 75 mg/m2 every three weeks and gefitinib 250 mg orally daily. Docetaxel and ZD1839 (gefitinib) were given for two cycles beyond maximal response. Gefitinib was continued until disease progression. Co-morbidities and activities of daily living were assessed (IADL).
311791|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.
docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
311792|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.
docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
311824|NCT00231777|E1|Reported Event|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
311825|NCT00224484|B4|Baseline|Total|Total of all reporting groups
311793|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.
docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
311794|NCT00231465|E1|Reported Event|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.
docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
311795|NCT00231478|B3|Baseline|Total|Total of all reporting groups
311796|NCT00231478|B2|Baseline|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
311797|NCT00231478|B1|Baseline|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
311798|NCT00231478|P2|Participant Flow|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
311799|NCT00231478|P1|Participant Flow|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
311800|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
311801|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
311802|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
311803|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
311804|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
311805|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
311806|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
311807|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
311808|NCT00231478|E2|Reported Event|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
311809|NCT00231478|E1|Reported Event|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
311810|NCT00231777|B3|Baseline|Total|Total of all reporting groups
311841|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
312024|NCT00225147|E1|Reported Event|100 IU/kg rhC1INH|Includes all subjects receiving 100 IU/kg Recombinant human C1 inhibitor
311811|NCT00231777|B2|Baseline|Ondansetron IV 4 mg|"On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
The formulation of MK0517 used in this study was a non polysorbate (PS80) formulation which was not further developed and is not available for use.
Data Reported is for all all participants who received active study therapy."
311812|NCT00231777|B1|Baseline|MK0517 Intravenous (IV) 40 mg|"On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
Data Reported is for all all participants who received active study therapy."
311813|NCT00231777|P2|Participant Flow|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
311814|NCT00231777|P1|Participant Flow|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
311815|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
311816|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
311817|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
311818|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
311819|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
311820|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
311821|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
311822|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
311823|NCT00231777|E2|Reported Event|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
311926|NCT00224874|B5|Baseline|Total|Total of all reporting groups
311826|NCT00224484|B3|Baseline|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311827|NCT00224484|B2|Baseline|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311828|NCT00224484|B1|Baseline|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311829|NCT00224484|P3|Participant Flow|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311830|NCT00224484|P2|Participant Flow|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311831|NCT00224484|P1|Participant Flow|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311832|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311833|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311834|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311835|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311836|NCT00224484|O2|Outcome|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups.
311837|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311838|NCT00224484|O2|Outcome|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups.
311839|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311840|NCT00224484|O2|Outcome|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups.
312918|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
311842|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311843|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311844|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311845|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311846|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311847|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311848|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311849|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311850|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311851|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311852|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311853|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311854|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311855|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311856|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311857|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311858|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311859|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311860|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311861|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311862|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311863|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311864|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311865|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311866|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311867|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311868|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311869|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311870|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
312614|NCT00235716|P3|Participant Flow|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
311871|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311872|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311873|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311874|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311875|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311876|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311877|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311878|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311879|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311880|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311881|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311882|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311883|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311884|NCT00224484|E5|Reported Event|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups, included in the Extended Safety Follow Up (ESFU) period.
311885|NCT00224484|E4|Reported Event|GD2-AS04 (ESFU) Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311886|NCT00224484|E3|Reported Event|Group Saline|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311887|NCT00224484|E2|Reported Event|Group Havrix|Female subjects aged 10-17 years, who received 3 doses of Havrix™ vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311888|NCT00224484|E1|Reported Event|Group GD2-AS04|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
311889|NCT00224770|B4|Baseline|Total|Total of all reporting groups
311890|NCT00224770|B3|Baseline|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311891|NCT00224770|B2|Baseline|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311892|NCT00224770|B1|Baseline|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311893|NCT00224770|P3|Participant Flow|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311894|NCT00224770|P2|Participant Flow|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311895|NCT00224770|P1|Participant Flow|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311896|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311948|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
311897|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311898|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311899|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311900|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311901|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311902|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311903|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311904|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311905|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311927|NCT00224874|B4|Baseline|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
311928|NCT00224874|B3|Baseline|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
312133|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
311906|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311907|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311908|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311909|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311910|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311911|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting technique as the MISTIE arm. No rt-PA administered, and in addition to best medical care.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311912|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311913|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311914|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311915|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311916|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311917|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311918|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311919|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311920|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311921|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311922|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311923|NCT00224770|E3|Reported Event|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots."
311924|NCT00224770|E2|Reported Event|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots."
311925|NCT00224770|E1|Reported Event|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
311929|NCT00224874|B2|Baseline|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311930|NCT00224874|B1|Baseline|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311931|NCT00224874|P4|Participant Flow|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
311932|NCT00224874|P3|Participant Flow|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
311933|NCT00224874|P2|Participant Flow|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311934|NCT00224874|P1|Participant Flow|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311935|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
311936|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
311937|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311938|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311939|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
311940|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
311941|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311942|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311943|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
311944|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
311945|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311946|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311947|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
312023|NCT00225147|E2|Reported Event|50 IU/kg rhC1INH|Includes all subjects receiving 50 IU/kg Recombinant human C1 inhibitor
311949|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311950|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311951|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
311952|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
311953|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311954|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311955|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
311956|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
311957|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311958|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311959|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
311960|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
311961|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311962|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311963|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
311964|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
311965|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311966|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311967|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
311968|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
311969|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311970|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311971|NCT00224874|E4|Reported Event|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
311972|NCT00224874|E3|Reported Event|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
311973|NCT00224874|E2|Reported Event|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
311974|NCT00224874|E1|Reported Event|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
311975|NCT00224952|B4|Baseline|Total|Total of all reporting groups
311976|NCT00224952|B3|Baseline|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
311977|NCT00224952|B2|Baseline|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
311978|NCT00224952|B1|Baseline|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
311979|NCT00224952|P3|Participant Flow|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
311980|NCT00224952|P2|Participant Flow|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
311981|NCT00224952|P1|Participant Flow|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
311982|NCT00224952|O3|Outcome|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
311983|NCT00224952|O2|Outcome|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
311984|NCT00224952|O1|Outcome|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
311985|NCT00224952|O3|Outcome|Valproic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
311986|NCT00224952|O2|Outcome|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
311987|NCT00224952|O1|Outcome|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
311988|NCT00224952|E3|Reported Event|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
311989|NCT00224952|E2|Reported Event|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
311990|NCT00224952|E1|Reported Event|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
311991|NCT00225017|B3|Baseline|Total|Total of all reporting groups
311992|NCT00225017|B2|Baseline|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
311993|NCT00225017|B1|Baseline|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.
Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
311994|NCT00225017|P2|Participant Flow|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
311995|NCT00225017|P1|Participant Flow|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.
Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
311996|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
311997|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.
Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
311998|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
311999|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.
Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
312000|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
312001|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.
Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
312002|NCT00225017|E2|Reported Event|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
312126|NCT00233090|B2|Baseline|Placebo|daily dose of placebo for four weeks
312003|NCT00225017|E1|Reported Event|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.
Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
312004|NCT00225147|B5|Baseline|Total|Total of all reporting groups
312005|NCT00225147|B4|Baseline|"50 IU/kg Open-label rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT)analysis population, which included all subjects who received 50 IU/kg open-label rhC1INH."
312006|NCT00225147|B3|Baseline|Placebo|"Baseline characteristics were calculated for the modified intention to treat (mITT) analysis population, which included all subjects randomized to the placebo arm."
312007|NCT00225147|B2|Baseline|"50 IU/kg rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT) and per protocol analysis populations, which included subjects who received 50 IU/kg rhC1INH. One (1) subject was randomized to the 50 IU/kg rhC1INH arm, but did not receive study drug administration and was excluded from the mITT analysis population."
312008|NCT00225147|B1|Baseline|"100 IU/kg rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT) and per protocol analysis populations, which included all subjects who received 100 IU/kg rhC1INH."
312009|NCT00225147|P4|Participant Flow|"50 IU/kg Open-label rhC1INH"|"Includes all subjects treated with 50 IU/kg open-label rhC1INH in the open-label phase."
312010|NCT00225147|P3|Participant Flow|Placebo|Includes all subjects randomized and treated with Placebo in the double-blind phase
312011|NCT00225147|P2|Participant Flow|"50 IU/kg rhC1INH"|Includes all subjects randomized and treated with 50 IU/kg Recombinant human C1 inhibitor in the double-blind phase
312012|NCT00225147|P1|Participant Flow|"100 IU/kg rhC1INH"|Includes all subjects randomized and treated with 100 IU/kg Recombinant human C1 inhibitor in the double-blind phase
312013|NCT00225147|O4|Outcome|"50 IU/kg Open-label rhC1INH"|Includes all subjects who received 50 IU/kg open-label Recombinant human C1 inhibitor
312014|NCT00225147|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Saline arm
312015|NCT00225147|O2|Outcome|"50 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 50 IU/kg Recombinant human C1 inhibitor arm
312016|NCT00225147|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 100 IU/kg Recombinant human C1 inhibitor arm
312017|NCT00225147|O4|Outcome|"50 IU/kg Open-label rhC1INH"|Includes all subjects who received 50 IU/kg open-label Recombinant human C1 inhibitor
312018|NCT00225147|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Saline arm
312019|NCT00225147|O2|Outcome|"50 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 50 IU/kg body weight recombinant human C1 Inhibitor arm
312020|NCT00225147|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 100 IU/kg body weight recombinant human C1 Inhibitor arm
312021|NCT00225147|E4|Reported Event|"50 IU/kg Open-label rhC1INH"|"Includes all subjects receiving 50 IU/kg open-label recombinant human C1 inhibitor and subjects receiving an additional dose of 50 IU/kg rhC1INH within 4 hours after initial administration."
312022|NCT00225147|E3|Reported Event|Placebo|Includes all subjects receiving Saline solution
312025|NCT00225212|B1|Baseline|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
312026|NCT00225212|P1|Participant Flow|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
312027|NCT00225212|O1|Outcome|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
312028|NCT00225212|O1|Outcome|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
312029|NCT00225212|E1|Reported Event|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
312030|NCT00225251|B3|Baseline|Total|Total of all reporting groups
312031|NCT00225251|B2|Baseline|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
312032|NCT00225251|B1|Baseline|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication"
312033|NCT00225251|P2|Participant Flow|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
312034|NCT00225251|P1|Participant Flow|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication"
312035|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
312036|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication"
312037|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
312038|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication"
312039|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
312040|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication"
312041|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
312042|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication"
312043|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
312044|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication"
312045|NCT00225251|E2|Reported Event|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
312046|NCT00225251|E1|Reported Event|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication"
312047|NCT00225277|B3|Baseline|Total|Total of all reporting groups
312048|NCT00225277|B2|Baseline|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
312049|NCT00225277|B1|Baseline|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
312050|NCT00225277|P2|Participant Flow|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
312051|NCT00225277|P1|Participant Flow|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
312052|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
312053|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
312054|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
312055|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
312056|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
312057|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
312058|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
312059|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
312060|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
312061|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
312062|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
312063|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
312064|NCT00225277|E2|Reported Event|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
312065|NCT00225277|E1|Reported Event|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
312066|NCT00225420|B1|Baseline|Overall Study|"Single Arm Docetaxel: Docetaxel will be administered per the designated cohort starting at 10, 15 or 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
312780|NCT00236080|E2|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
312067|NCT00225420|P3|Participant Flow|Docetaxel 20 mg/m2|"Single Arm
docetaxel: Docetaxel will be administered per the designated cohort starting at 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
312068|NCT00225420|P2|Participant Flow|Docetaxel 15 mg/m2|"Single Arm
docetaxel: Docetaxel will be administered per the designated cohort starting at 15 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
312069|NCT00225420|P1|Participant Flow|Docetaxel 10 mg/m2|"Single Arm
docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
radiation therapy: The total dose will be 7800 centigray (cGy) in 200 cGy per fraction for a total of 39 treatments."
312070|NCT00225420|O1|Outcome|Single Arm|"Single Arm
docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
312071|NCT00225420|O3|Outcome|Docetaxel 20 mg/m2|"Single Arm
docetaxel: Docetaxel will be administered per the designated cohort starting at 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
312072|NCT00225420|O2|Outcome|Docetaxel 15 mg/m2|"Single Arm
docetaxel: Docetaxel will be administered per the designated cohort starting at 15 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
312073|NCT00225420|O1|Outcome|Docetaxel at 10 mg/m2|"Single Arm
docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
312074|NCT00225420|E1|Reported Event|Single Arm|"Single Arm
docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
312075|NCT00225498|B1|Baseline|All Participants|Baseline characteristics for all participants prior to randomization are reported because treatment assignment information is not available. That information was not preserved when the orginally planned analyses were not conducted because the enrollment was insufficient for statistically valid results.
312076|NCT00225498|P1|Participant Flow|Ziprasidone|ziprasidone target dose is 160 mg/day
312077|NCT00225498|O1|Outcome|Ziprasidone|ziprasidone target dose is 160 mg/day
312078|NCT00225498|E1|Reported Event|Ziprasidone|
312079|NCT00225732|B3|Baseline|Total|Total of all reporting groups
312080|NCT00225732|B2|Baseline|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
312081|NCT00225732|B1|Baseline|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
312082|NCT00225732|P2|Participant Flow|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
312106|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
312165|NCT00233324|B3|Baseline|Early Surfactant and Lower Range Oxygen|Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in lower range (85-90%)
312083|NCT00225732|P1|Participant Flow|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
312084|NCT00225732|O2|Outcome|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
312085|NCT00225732|O1|Outcome|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
312086|NCT00225732|E2|Reported Event|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
312127|NCT00233090|B1|Baseline|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
312128|NCT00233090|P2|Participant Flow|Placebo|daily dose of placebo for four weeks
312129|NCT00233090|P1|Participant Flow|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
312087|NCT00225732|E1|Reported Event|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
312088|NCT00225784|B1|Baseline|Cetuximab/Gemcitabine/Radiotherapy|weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
312089|NCT00225784|P1|Participant Flow|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
312090|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
312091|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
312092|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
312093|NCT00225784|O2|Outcome|Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors|Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
312094|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy in EGFR (-) Tumors|Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR negative tumors.
312095|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
312096|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
312097|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.
312098|NCT00225784|E1|Reported Event|Cetuximab/Gemcitabine/Radiotherapy|weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
312099|NCT00231816|B3|Baseline|Total|Total of all reporting groups
312100|NCT00231816|B2|Baseline|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
312101|NCT00231816|B1|Baseline|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
312102|NCT00231816|P2|Participant Flow|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
312103|NCT00231816|P1|Participant Flow|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
312104|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
312105|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
312781|NCT00236080|E1|Reported Event|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
312107|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
312108|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
312109|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
312110|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL SC injection administered comcomitantly with 0.5 mL IM influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
312111|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
312112|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
312113|NCT00231816|E2|Reported Event|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
312114|NCT00231816|E1|Reported Event|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
312115|NCT00233064|B3|Baseline|Total|Total of all reporting groups
312116|NCT00233064|B2|Baseline|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
312117|NCT00233064|B1|Baseline|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
312118|NCT00233064|P2|Participant Flow|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
312119|NCT00233064|P1|Participant Flow|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
312120|NCT00233064|O3|Outcome|Combined Liquid/Lyophilized Palivizumab|
312121|NCT00233064|O2|Outcome|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
312122|NCT00233064|O1|Outcome|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
312123|NCT00233064|E2|Reported Event|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
312124|NCT00233064|E1|Reported Event|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
312125|NCT00233090|B3|Baseline|Total|Total of all reporting groups
312135|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
312136|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
312137|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
312138|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
312139|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
312140|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
312141|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
312142|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
312143|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
312144|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
312145|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
312146|NCT00233090|E2|Reported Event|Placebo|daily dose of placebo for four weeks
312147|NCT00233090|E1|Reported Event|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
312148|NCT00233103|B3|Baseline|Total|Total of all reporting groups
312149|NCT00233103|B2|Baseline|Placebo|Placebo for 10 weeks
312150|NCT00233103|B1|Baseline|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
312151|NCT00233103|P2|Participant Flow|Placebo|Placebo for 10 weeks
312152|NCT00233103|P1|Participant Flow|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg) for 10 weeks
312153|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
312154|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
312155|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
312156|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
312157|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
312158|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
312159|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
312160|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
312161|NCT00233103|E2|Reported Event|Placebo|Placebo for 10 weeks
312162|NCT00233103|E1|Reported Event|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
312163|NCT00233324|B5|Baseline|Total|Total of all reporting groups
312164|NCT00233324|B4|Baseline|Early Surfactant and Higher Range Oxygen|Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in higher range (91-95%)
312166|NCT00233324|B2|Baseline|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen adminstered in higher range (91-95%)
312167|NCT00233324|B1|Baseline|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen administered in lower range (85-90%)
312168|NCT00233324|P4|Participant Flow|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
312169|NCT00233324|P3|Participant Flow|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation
312170|NCT00233324|P2|Participant Flow|Early Surfactant and Higher Range Oxygen|Early Surfactant and 91-95% target oxygen saturation
312171|NCT00233324|P1|Participant Flow|Early Surfactant and Lower Range Oxygen|Early Surfactant and 85-89% target oxygen saturation
312172|NCT00233324|O4|Outcome|Higher Oxygen Saturation Target|SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
312173|NCT00233324|O3|Outcome|Lower Oxygen Saturation Target|SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
312174|NCT00233324|O2|Outcome|Surfactant|Intubation and administration of surfactant by 1 hour of age
312175|NCT00233324|O1|Outcome|CPAP|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
312176|NCT00233324|O2|Outcome|Higher Oxygen Saturation Target|SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
312177|NCT00233324|O1|Outcome|Lower Oxygen Saturation Target|SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
312178|NCT00233324|O2|Outcome|Surfactant|Intubation and administration of surfactant by 1 hour of age
312179|NCT00233324|O1|Outcome|CPAP|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
312180|NCT00233324|E4|Reported Event|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
312181|NCT00233324|E3|Reported Event|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation
312182|NCT00233324|E2|Reported Event|Surfactant and Higher Range Oxygen|Early Surfactant and 91-95% target oxygen saturation
312183|NCT00233324|E1|Reported Event|Surfactant and Lower Range Oxygen|Early Surfactant and 85-89% target oxygen saturation
312184|NCT00233402|B3|Baseline|Total|Total of all reporting groups
312185|NCT00233402|B2|Baseline|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
312186|NCT00233402|B1|Baseline|Comparator|Standard White Light Cystoscopy
312187|NCT00233402|P2|Participant Flow|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
312188|NCT00233402|P1|Participant Flow|Comparator|Standard White Light Cystoscopy
312189|NCT00233402|O1|Outcome|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
312190|NCT00233402|O2|Outcome|White Light Group|
312191|NCT00233402|O1|Outcome|Hexvix Group|
312192|NCT00233402|O2|Outcome|White Light Group|
312193|NCT00233402|O1|Outcome|Hexvix Group|
312194|NCT00233402|O2|Outcome|White Light Group|
312195|NCT00233402|O1|Outcome|Hexvix Group|The primary endpoint was assessed from patients randomized to the Hexvix group only
312196|NCT00233402|E2|Reported Event|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
312197|NCT00233402|E1|Reported Event|Comparator|Standard White Light Cystoscopy
312198|NCT00233454|B1|Baseline|Midostaurin|"100 mg midostaurin twice daily as oral capsules
Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
312199|NCT00233454|P1|Participant Flow|Midostaurin|"100 mg midostaurin twice daily as oral capsules
Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
312200|NCT00233454|O1|Outcome|Midostaurin|"100 mg midostaurin twice daily as oral capsules
Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
312201|NCT00233454|O1|Outcome|Midostaurin|"100 mg midostaurin twice daily as oral capsules
Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
312202|NCT00233454|E1|Reported Event|Midostaurin|"100 mg midostaurin twice daily as oral capsules
Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
312203|NCT00233519|B3|Baseline|Total|Total of all reporting groups
312204|NCT00233519|B2|Baseline|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
312205|NCT00233519|B1|Baseline|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
312206|NCT00233519|P2|Participant Flow|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
312207|NCT00233519|P1|Participant Flow|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
312291|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312208|NCT00233519|O2|Outcome|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
312209|NCT00233519|O1|Outcome|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
312210|NCT00233519|E2|Reported Event|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
312211|NCT00233519|E1|Reported Event|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
312212|NCT00233948|B3|Baseline|Total|Total of all reporting groups
312213|NCT00233948|B2|Baseline|Phase II|Oral Nelfinavir at 3000 mg bid
312214|NCT00233948|B1|Baseline|Phase I|Phase I dose escalation portion of the study. Initial dose of oral Nelfinavir was 1250 mg bid with escalation to the MTD at 4250 mg bid using a standard 3+3 dose escalation scheme.
312215|NCT00233948|P6|Participant Flow|Phase II|Oral Nelfinavir at 3000mg bid
312216|NCT00233948|P5|Participant Flow|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
312217|NCT00233948|P4|Participant Flow|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
312218|NCT00233948|P3|Participant Flow|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
312219|NCT00233948|P2|Participant Flow|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
312220|NCT00233948|P1|Participant Flow|Phase I: Dose Level 1|Oral Nelfinavir at 1250mg bid.
312221|NCT00233948|O1|Outcome|Phase II|Oral Nelfinavir at 3000 mg bid
312222|NCT00233948|O1|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
312223|NCT00233948|O5|Outcome|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
312224|NCT00233948|O4|Outcome|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
312225|NCT00233948|O3|Outcome|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
312226|NCT00233948|O2|Outcome|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
312227|NCT00233948|O1|Outcome|Phase I: Dose Level I|Oral Nelfinavir at 1250mg bid.
312228|NCT00233948|E6|Reported Event|Phase II|Oral Nelfinavir at 3000 mg bid
312229|NCT00233948|E5|Reported Event|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
312230|NCT00233948|E4|Reported Event|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
312231|NCT00233948|E3|Reported Event|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
312232|NCT00233948|E2|Reported Event|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
312233|NCT00233948|E1|Reported Event|Phase I: Dose Level I|Oral Nelfinavir at 1250mg bid.
312234|NCT00233987|B1|Baseline|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
312595|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
312235|NCT00233987|P1|Participant Flow|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either Total Body Irradiation(TBI)-based or 1,3-bis (2-chloroethyl)-1-nitrosourea(BCNU)-based high-dose therapy followed by infusion of at least 2 million cluster of differentiation 34 positive (CD34+) cells.
312236|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
312237|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
312238|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
312239|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
312240|NCT00233987|E1|Reported Event|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
312241|NCT00234039|B1|Baseline|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
312242|NCT00234039|P1|Participant Flow|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
312292|NCT00234078|E4|Reported Event|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312293|NCT00234078|E3|Reported Event|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312243|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
312244|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
312245|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
312246|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
312247|NCT00234039|E1|Reported Event|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
312248|NCT00234065|B3|Baseline|Total|Total of all reporting groups
312249|NCT00234065|B2|Baseline|Aspirin|Aspirin, oral tablet, 81 mg aspirin
312250|NCT00234065|B1|Baseline|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
312251|NCT00234065|P2|Participant Flow|Aspirin|Aspirin, oral tablet, 81 mg aspirin
312252|NCT00234065|P1|Participant Flow|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
312253|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
312254|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
312255|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
312256|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
312257|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
312258|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
312259|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
312260|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
312261|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
312262|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
312263|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
312264|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
312265|NCT00234065|E2|Reported Event|Aspirin|Aspirin, oral tablet, 81 mg aspirin
312266|NCT00234065|E1|Reported Event|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
312267|NCT00234078|B5|Baseline|Total|Total of all reporting groups
312268|NCT00234078|B4|Baseline|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312269|NCT00234078|B3|Baseline|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312270|NCT00234078|B2|Baseline|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312271|NCT00234078|B1|Baseline|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312272|NCT00234078|P4|Participant Flow|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312273|NCT00234078|P3|Participant Flow|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312274|NCT00234078|P2|Participant Flow|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312275|NCT00234078|P1|Participant Flow|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312276|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312277|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312278|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312279|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312280|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312281|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312282|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312283|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312284|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312285|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312286|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312287|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312288|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312289|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312290|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312294|NCT00234078|E2|Reported Event|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312295|NCT00234078|E1|Reported Event|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
312296|NCT00234104|B5|Baseline|Total|Total of all reporting groups
312297|NCT00234104|B4|Baseline|45 mg of OPC-41061|OPC-41061 45 mg/day
312298|NCT00234104|B3|Baseline|30 mg of OPC-41061|OPC-41061 30 mg/day
312299|NCT00234104|B2|Baseline|15 mg of OPC-41061|OPC-41061 15 mg/day
312300|NCT00234104|B1|Baseline|Placebo|OPC-41061 0 mg/day
312301|NCT00234104|P4|Participant Flow|45 mg of OPC-41061|OPC-41061 45 mg/day
312302|NCT00234104|P3|Participant Flow|30 mg of OPC-41061|OPC-41061 30 mg/day
312303|NCT00234104|P2|Participant Flow|15 mg of OPC-41061|OPC-41061 15 mg/day
312304|NCT00234104|P1|Participant Flow|Placebo|OPC-41061 0 mg/day
312305|NCT00234104|O4|Outcome|45 mg of OPC-41061|OPC-41061 45 mg/day
312306|NCT00234104|O3|Outcome|30 mg of OPC-41061|OPC-41061 30 mg/day
312307|NCT00234104|O2|Outcome|15 mg of OPC-41061|OPC-41061 15 mg/day
312308|NCT00234104|O1|Outcome|Placebo|OPC-41061 0 mg/day
312309|NCT00234104|E4|Reported Event|45 mg of OPC-41061|OPC-41061 45 mg/day
312310|NCT00234104|E3|Reported Event|30 mg of OPC-41061|OPC-41061 30 mg/day
312311|NCT00234104|E2|Reported Event|15 mg of OPC-41061|OPC-41061 15 mg/day
312312|NCT00234104|E1|Reported Event|Placebo|OPC-41061 0 mg/day
312313|NCT00234286|B1|Baseline|Arm 1|"Comfort care education intervention, consisting of on-site staff training together with an electronic order set for palliative care and educational materials
Comfort care education intervention: Comfort care education intervention, consisting of on-site staff training together with an electronic order set for palliative care and educational materials"
312314|NCT00234286|P1|Participant Flow|BEACON Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
312315|NCT00234286|O2|Outcome|Post-Intervention|Individuals with documented Palliative Care Consultation pre-intervention in their medical record
312316|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with documented Palliative Care Consultation pre-intervention in their medical record
312317|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Advanced Directive post-intervention based on abstraction of medical record
312318|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Advanced Directive pre-intervention based on abstraction of medical record
312319|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Pastoral Care visit post-intervention based on abstraction of medical record
312320|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Pastoral Care Visit pre-intervention based on abstraction of medical record
312321|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Sublingual administration of medication during post-intervention based on abstraction of medical record
312322|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Sublingual administration of medication during pre-intervention based on abstraction of medical record
312323|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of scopolamine (for death rattle) during post -intervention based on abstraction of medical record
312324|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of scopolamine (for death rattle) during pre-intervention based on abstraction of medical record
312325|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of benzodiazepine medication during post-intervention based on abstraction of medical record
312326|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of benzodiazepine medication during pre-intervention based on abstraction of medical record
312327|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Order for benzodiazepine medication during post-intervention period based on abstraction of medical record
312328|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Order for benzodiazepine medication during pre-intervention period based on abstraction of medical record
312329|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of antipsychotic medication post-intervention
312330|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of antipsychotic medication pre-intervention
312331|NCT00234286|O2|Outcome|Post-Intervention|Individuals with antipsychotic medication ordered post-intervention
312332|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with antipsychotic medication ordered pre-intervention
312333|NCT00234286|O2|Outcome|Post-intervention|Individuals who received opioid medication post-intervention
312334|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who received opioid medication pre-intervention
312335|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with restraints during post-intervention
312336|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with restraints during pre-intervention
312337|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with an intravenous line post-intervention
312338|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with an intravenous line pre-intervention
312339|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with a nasogastric tube post-intervention
312340|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with a nasogastric tube pre-intervention
312341|NCT00234286|O2|Outcome|Post-Intervention|Number of Patients who died in ICU Post-Intervention
312342|NCT00234286|O1|Outcome|Pre-Intervention|Number of Individuals who died in ICU Pre-Intervention
312343|NCT00234286|O2|Outcome|Post-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
312395|NCT00235326|P1|Participant Flow|Unexposed to Gastroenteritis|
312344|NCT00234286|O1|Outcome|Pre-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
312345|NCT00234286|O2|Outcome|Post-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
312346|NCT00234286|O1|Outcome|Pre-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
312347|NCT00234286|E1|Reported Event|Arm 1|Arm 1: Comfort care education intervention, consisting of intensive, on-site staff training
312348|NCT00234494|B1|Baseline|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1"
312349|NCT00234494|P1|Participant Flow|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1"
312350|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1"
312351|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1"
312352|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1"
312353|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1"
312354|NCT00234494|E1|Reported Event|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1"
312355|NCT00234832|B3|Baseline|Total|Total of all reporting groups
312356|NCT00234832|B2|Baseline|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312357|NCT00234832|B1|Baseline|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312454|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312358|NCT00234832|P2|Participant Flow|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312359|NCT00234832|P1|Participant Flow|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312360|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312361|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312362|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312363|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312364|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312365|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312366|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312367|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312368|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312369|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312370|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312371|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312372|NCT00234832|O8|Outcome|CV + DM Randomized to Placebo|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
312373|NCT00234832|O7|Outcome|CV + DM Randomized to Sibutramine|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
312374|NCT00234832|O6|Outcome|CV Only Randomized to Placebo|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
312375|NCT00234832|O5|Outcome|CV Only Randomized to Sibutramine|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
312376|NCT00234832|O4|Outcome|DM Only Randomized to Placebo|Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
312414|NCT00235391|O3|Outcome|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312377|NCT00234832|O3|Outcome|DM Only Randomized to Sibutramine|Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
312378|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312379|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
312380|NCT00234832|E3|Reported Event|Randomized Placebo|Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive placebo plus standard care for weight management during the Treatment Period of the Randomizaiton Phase, and if placebo was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
312381|NCT00234832|E2|Reported Event|Randomized Sibutramine|Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive sibutramine plus standard care for weight management during the Treatment Period of the Randomization Phase, and if sibutramine was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
312382|NCT00234832|E1|Reported Event|Lead-in Period Sibutramine|Subjects who received sibutramine 10 mg QD plus standard care for weight management during a 6-week Lead-in Period.
312383|NCT00234884|B1|Baseline|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
312384|NCT00234884|P1|Participant Flow|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
312385|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
312386|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
312387|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
312388|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
312389|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
312390|NCT00234884|E1|Reported Event|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
312391|NCT00235326|B3|Baseline|Total|Total of all reporting groups
312392|NCT00235326|B2|Baseline|Exposed to Gastroenteritis|
312393|NCT00235326|B1|Baseline|Unexposed to Gastroenteritis|
312394|NCT00235326|P2|Participant Flow|Exposed to Gastroenteritis|
312399|NCT00235391|B6|Baseline|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312400|NCT00235391|B5|Baseline|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312401|NCT00235391|B4|Baseline|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312402|NCT00235391|B3|Baseline|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312403|NCT00235391|B2|Baseline|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312404|NCT00235391|B1|Baseline|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312405|NCT00235391|P6|Participant Flow|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312406|NCT00235391|P5|Participant Flow|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312407|NCT00235391|P4|Participant Flow|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312408|NCT00235391|P3|Participant Flow|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312409|NCT00235391|P2|Participant Flow|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312410|NCT00235391|P1|Participant Flow|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312411|NCT00235391|O6|Outcome|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312412|NCT00235391|O5|Outcome|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312413|NCT00235391|O4|Outcome|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312415|NCT00235391|O2|Outcome|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312416|NCT00235391|O1|Outcome|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312417|NCT00235391|O6|Outcome|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312418|NCT00235391|O5|Outcome|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312419|NCT00235391|O4|Outcome|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312420|NCT00235391|O3|Outcome|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312421|NCT00235391|O2|Outcome|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312422|NCT00235391|O1|Outcome|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312423|NCT00235391|E1|Reported Event|All Participants|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
312424|NCT00235443|B7|Baseline|Total|Total of all reporting groups
312425|NCT00235443|B6|Baseline|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312426|NCT00235443|B5|Baseline|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312427|NCT00235443|B4|Baseline|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312428|NCT00235443|B3|Baseline|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312429|NCT00235443|B2|Baseline|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312430|NCT00235443|B1|Baseline|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312431|NCT00235443|P6|Participant Flow|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312432|NCT00235443|P5|Participant Flow|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312433|NCT00235443|P4|Participant Flow|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312434|NCT00235443|P3|Participant Flow|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312435|NCT00235443|P2|Participant Flow|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312436|NCT00235443|P1|Participant Flow|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312437|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312438|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312439|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312440|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312441|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312442|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312443|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312444|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312445|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312446|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312447|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312448|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312449|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312450|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312451|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312452|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312453|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
315872|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
312455|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312456|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312457|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312458|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312459|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312460|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312461|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312462|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312463|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312464|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312465|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312466|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312467|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312468|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312469|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312470|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312471|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312472|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312473|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312474|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312475|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312476|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312477|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312478|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312479|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312480|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312481|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312482|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312483|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312484|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312485|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312486|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312487|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312488|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312489|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312490|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312491|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312492|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312493|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312494|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312495|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312496|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312497|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312498|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312499|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312500|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312501|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312502|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312503|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312504|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312505|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312506|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312507|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312508|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312509|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312510|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312511|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312512|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312513|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312514|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312515|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312516|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312517|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312518|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312519|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312520|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312521|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312522|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312523|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312524|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312525|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312526|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312527|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312528|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312529|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312530|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312531|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312532|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312533|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312534|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312535|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312536|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312537|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312538|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312539|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312540|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312541|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312542|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312543|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312544|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312545|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312546|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312547|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312548|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312549|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312550|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312551|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312552|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312553|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312554|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312555|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312556|NCT00235443|O7|Outcome|Total|All modal dose groups combined
312557|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312558|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312559|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312560|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312561|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312562|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312563|NCT00235443|E7|Reported Event|Total|All modal dose groups combined
312564|NCT00235443|E6|Reported Event|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312565|NCT00235443|E5|Reported Event|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312566|NCT00235443|E4|Reported Event|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312567|NCT00235443|E3|Reported Event|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312568|NCT00235443|E2|Reported Event|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312569|NCT00235443|E1|Reported Event|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
312570|NCT00235456|B3|Baseline|Total|Total of all reporting groups
312571|NCT00235456|B2|Baseline|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312572|NCT00235456|B1|Baseline|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312573|NCT00235456|P2|Participant Flow|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312574|NCT00235456|P1|Participant Flow|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312593|NCT00229203|P1|Participant Flow|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
312594|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
312575|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312576|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312577|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312578|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312579|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312580|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312581|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312582|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312782|NCT00236184|B3|Baseline|Total|Total of all reporting groups
312583|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312584|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312585|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312586|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312587|NCT00235456|E2|Reported Event|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312588|NCT00235456|E1|Reported Event|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
312589|NCT00229203|B3|Baseline|Total|Total of all reporting groups
312590|NCT00229203|B2|Baseline|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
312591|NCT00229203|B1|Baseline|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
312592|NCT00229203|P2|Participant Flow|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
312596|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
312597|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
312598|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
312599|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
312600|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
312601|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
312602|NCT00229203|E2|Reported Event|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
312603|NCT00229203|E1|Reported Event|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
312604|NCT00235573|B1|Baseline|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
312605|NCT00235573|P1|Participant Flow|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
312606|NCT00235573|O1|Outcome|Vitamin B12 Group|All subjects received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
312607|NCT00235573|E1|Reported Event|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
312608|NCT00235716|B5|Baseline|Total|Total of all reporting groups
312609|NCT00235716|B4|Baseline|Placebo|Matching placebo pills for vitamin E and memantine
312610|NCT00235716|B3|Baseline|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
312611|NCT00235716|B2|Baseline|Memantine (Namenda)|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
312612|NCT00235716|B1|Baseline|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
312613|NCT00235716|P4|Participant Flow|Placebo|Matching placebo pills for vitamin E and memantine
328540|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
312615|NCT00235716|P2|Participant Flow|Memantine (Namenda)|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
312616|NCT00235716|P1|Participant Flow|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
312617|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
312618|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
312619|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
312620|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
312621|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
312622|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
312623|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
312624|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
312625|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
312626|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
312627|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
312628|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
312629|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
312630|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
312631|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
312632|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
312633|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
312634|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
312635|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
312636|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
315873|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
312637|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
312638|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
312639|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
312640|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
312641|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
312642|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
312643|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
312644|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
312645|NCT00235716|E4|Reported Event|Placebo|Matching placebo pills for vitamin E and memantine
312646|NCT00235716|E3|Reported Event|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
312647|NCT00235716|E2|Reported Event|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
312648|NCT00235716|E1|Reported Event|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
312649|NCT00235755|B4|Baseline|Total|Total of all reporting groups
312650|NCT00235755|B3|Baseline|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312651|NCT00235755|B2|Baseline|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312652|NCT00235755|B1|Baseline|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
312653|NCT00235755|P3|Participant Flow|Retigabine 300 mg TID|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the 12-week Maintenance Phase.
312654|NCT00235755|P2|Participant Flow|Retigabine 200 mg TID|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the 12-week Maintenance Phase.
312655|NCT00235755|P1|Participant Flow|Placebo|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase. Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 12-week Maintenance Phase.
312656|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312657|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312658|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312659|NCT00235755|O3|Outcome|Retigabine 300 mg TID: Maintenance Phase|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the 12-week Maintenance Phase
312660|NCT00235755|O2|Outcome|Retigabine 200 mg TID: Maintenance Phase|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the 12-week Maintenance Phase
312661|NCT00235755|O1|Outcome|Placebo: Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 12-week Maintenance Phase
312662|NCT00235755|O6|Outcome|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
312663|NCT00235755|O5|Outcome|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
315874|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
312664|NCT00235755|O4|Outcome|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
312665|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312666|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312667|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312668|NCT00235755|O6|Outcome|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
312669|NCT00235755|O5|Outcome|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
312670|NCT00235755|O4|Outcome|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
312671|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312783|NCT00236184|B2|Baseline|Rabeprazole 10 mg|oral enteric-coated tablet
312672|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312673|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312674|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312675|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312676|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312677|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312678|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312679|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312680|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312681|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312682|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312683|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312684|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312685|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312686|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312687|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312688|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312689|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312690|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312691|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312692|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312693|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312694|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312695|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312696|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312697|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312698|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312699|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312700|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312750|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
315875|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
312701|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312702|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312703|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312704|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312705|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312706|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312707|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312708|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312709|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312729|NCT00235833|P1|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312710|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312711|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312712|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312713|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312714|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312715|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
312716|NCT00235755|O3|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312717|NCT00235755|O2|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312718|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12 week Maintenance Phase
312751|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
314101|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
312719|NCT00235755|O3|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312720|NCT00235755|O2|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312721|NCT00235755|O1|Outcome|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
312722|NCT00235755|E6|Reported Event|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
312723|NCT00235755|E5|Reported Event|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
312724|NCT00235755|E4|Reported Event|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
312725|NCT00235755|E3|Reported Event|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
312726|NCT00235755|E2|Reported Event|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
312727|NCT00235755|E1|Reported Event|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
312728|NCT00235833|B1|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312730|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312731|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312732|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312733|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312734|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312735|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312736|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312737|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312738|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312739|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312740|NCT00235833|E1|Reported Event|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
312741|NCT00235872|B1|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312742|NCT00235872|P1|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312743|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312744|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312745|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312746|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312747|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312748|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312749|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312752|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312753|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312754|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312755|NCT00235872|E1|Reported Event|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
312756|NCT00236080|B6|Baseline|Total|Total of all reporting groups
312757|NCT00236080|B5|Baseline|Placebo|Matching placebo tablets once daily only on nights worked
312758|NCT00236080|B4|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
312759|NCT00236080|B3|Baseline|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
312760|NCT00236080|B2|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
312761|NCT00236080|B1|Baseline|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
312762|NCT00236080|P5|Participant Flow|Placebo|Matching placebo tablets once daily only on nights worked
312763|NCT00236080|P4|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
312764|NCT00236080|P3|Participant Flow|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
312765|NCT00236080|P2|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
312766|NCT00236080|P1|Participant Flow|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
312767|NCT00236080|O5|Outcome|Placebo|Matching placebo tablets once daily only on nights worked
312768|NCT00236080|O4|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
312769|NCT00236080|O3|Outcome|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
312770|NCT00236080|O2|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
312771|NCT00236080|O1|Outcome|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
312772|NCT00236080|O5|Outcome|Placebo|Matching placebo tablets once daily only on nights worked
312773|NCT00236080|O4|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
312774|NCT00236080|O3|Outcome|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
312775|NCT00236080|O2|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
312776|NCT00236080|O1|Outcome|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
312777|NCT00236080|E5|Reported Event|Placebo|Matching placebo tablets once daily only on nights worked
312778|NCT00236080|E4|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
312779|NCT00236080|E3|Reported Event|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
312784|NCT00236184|B1|Baseline|Placebo|oral placebo tablet
312801|NCT00236899|B4|Baseline|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312802|NCT00236899|B3|Baseline|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312803|NCT00236899|B2|Baseline|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312804|NCT00236899|B1|Baseline|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312805|NCT00236899|P4|Participant Flow|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312806|NCT00236899|P3|Participant Flow|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312807|NCT00236899|P2|Participant Flow|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312853|NCT00236951|B4|Baseline|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
312887|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
312808|NCT00236899|P1|Participant Flow|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312809|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312810|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312811|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312812|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312813|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312814|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312815|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312841|NCT00236938|P1|Participant Flow|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
312816|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312817|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312818|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312819|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312820|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312854|NCT00236951|B3|Baseline|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
312888|NCT00236977|E2|Reported Event|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
312821|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
312822|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312823|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
312824|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312825|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312826|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312842|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
328541|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
312827|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
312828|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312829|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312855|NCT00236951|B2|Baseline|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
314102|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
312830|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312831|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312832|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312833|NCT00236899|E4|Reported Event|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312834|NCT00236899|E3|Reported Event|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312835|NCT00236899|E2|Reported Event|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312836|NCT00236899|E1|Reported Event|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
312837|NCT00236938|B3|Baseline|Total|Total of all reporting groups
312838|NCT00236938|B2|Baseline|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
312839|NCT00236938|B1|Baseline|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
312840|NCT00236938|P2|Participant Flow|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
312870|NCT00236977|B2|Baseline|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
312843|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
312844|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
312845|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
312846|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
312847|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
312848|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
312849|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
312850|NCT00236938|E2|Reported Event|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
312851|NCT00236938|E1|Reported Event|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
312852|NCT00236951|B5|Baseline|Total|Total of all reporting groups
314103|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
312856|NCT00236951|B1|Baseline|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
312857|NCT00236951|P4|Participant Flow|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
312858|NCT00236951|P3|Participant Flow|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
312859|NCT00236951|P2|Participant Flow|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
312860|NCT00236951|P1|Participant Flow|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
312861|NCT00236951|O4|Outcome|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
312862|NCT00236951|O3|Outcome|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
312863|NCT00236951|O2|Outcome|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
312864|NCT00236951|O1|Outcome|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
312865|NCT00236951|E4|Reported Event|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
312866|NCT00236951|E3|Reported Event|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
312867|NCT00236951|E2|Reported Event|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
312868|NCT00236951|E1|Reported Event|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
312869|NCT00236977|B3|Baseline|Total|Total of all reporting groups
312871|NCT00236977|B1|Baseline|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
312872|NCT00236977|P2|Participant Flow|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
312873|NCT00236977|P1|Participant Flow|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
312874|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
312875|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
312876|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
312877|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
312878|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
312879|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
312880|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
312881|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
312882|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
312883|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
312884|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
312885|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
312886|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
312889|NCT00236977|E1|Reported Event|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
312890|NCT00237042|B4|Baseline|Total|Total of all reporting groups
312891|NCT00237042|B3|Baseline|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
312892|NCT00237042|B2|Baseline|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
312893|NCT00237042|B1|Baseline|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
312894|NCT00237042|P3|Participant Flow|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
312895|NCT00237042|P2|Participant Flow|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
312896|NCT00237042|P1|Participant Flow|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
312897|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
312912|NCT00237185|B3|Baseline|Total|Total of all reporting groups
312913|NCT00237185|B2|Baseline|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312914|NCT00237185|B1|Baseline|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312898|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
312899|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
312900|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
312901|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
312902|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
312903|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
312946|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312947|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312904|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
312905|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
312906|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
312907|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
312908|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
312909|NCT00237042|E3|Reported Event|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
312910|NCT00237042|E2|Reported Event|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
312911|NCT00237042|E1|Reported Event|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
312919|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312920|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312921|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312922|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312923|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312924|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312925|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312926|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312927|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312928|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312929|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312930|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312931|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312932|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312933|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312934|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312935|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312936|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312937|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312938|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312939|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg
Imatinib mesylate"
312940|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg
Imatinib mesylate"
312941|NCT00237185|E2|Reported Event|Imatinib Mesylate 600 mg|600 mg
312942|NCT00237185|E1|Reported Event|Imatinib Mesylate 400 mg|400 mg
312943|NCT00237458|B1|Baseline|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312944|NCT00237458|P1|Participant Flow|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312945|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
314104|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
312948|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312949|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312950|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312951|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312952|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312953|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312954|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312955|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312956|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312957|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312958|NCT00237458|E1|Reported Event|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
312959|NCT00237666|B1|Baseline|Ziprasidone|
312960|NCT00237666|P1|Participant Flow|Ziprasidone|Patients will receive 8 weeks of active treatment with ziprasidone, initiated at 20mg BID. Depending on tolerability and clinical response, the dosage can be titrated up to a maximum of 60mg BID per day. Dosage can be lowered or temporarily stopped if necessary because of adverse events.
312961|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
312962|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
312963|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
312964|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
312965|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
312966|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
312967|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
312968|NCT00237666|E1|Reported Event|Ziprasidone|
312969|NCT00237692|B5|Baseline|Total|Total of all reporting groups
312970|NCT00237692|B4|Baseline|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
312971|NCT00237692|B3|Baseline|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
312972|NCT00237692|B2|Baseline|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
312973|NCT00237692|B1|Baseline|Arm 1- Control|A group of hypertensive patients who receive usual care
313093|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab
D-serine : D-serine (30 mg/kg)"
328542|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
312974|NCT00237692|P4|Participant Flow|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
312975|NCT00237692|P3|Participant Flow|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
312976|NCT00237692|P2|Participant Flow|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
312977|NCT00237692|P1|Participant Flow|Arm 1- Control|A group of hypertensive patients who receive usual care
312978|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
312979|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
312980|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
312981|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
312982|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
312983|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
312984|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
312985|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
312986|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
312987|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
312988|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
312989|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
312990|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
315876|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
312991|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
312992|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
312993|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
312994|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
312995|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
312996|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
312997|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
312998|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
312999|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
313000|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
313001|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
313002|NCT00237692|E4|Reported Event|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
313003|NCT00237692|E3|Reported Event|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
313004|NCT00237692|E2|Reported Event|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
313005|NCT00237692|E1|Reported Event|Arm 1- Control|A group of hypertensive patients who receive usual care
313006|NCT00237718|B3|Baseline|Total|Total of all reporting groups
313007|NCT00237718|B2|Baseline|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
313008|NCT00237718|B1|Baseline|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
313009|NCT00237718|P2|Participant Flow|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
313010|NCT00237718|P1|Participant Flow|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
313011|NCT00237718|O2|Outcome|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
313012|NCT00237718|O1|Outcome|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
313013|NCT00237718|O2|Outcome|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
313014|NCT00237718|O1|Outcome|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
313015|NCT00237718|E2|Reported Event|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
313016|NCT00237718|E1|Reported Event|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
313017|NCT00237744|B4|Baseline|Total|Total of all reporting groups
313018|NCT00237744|B3|Baseline|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow=wrist hand
313019|NCT00237744|B2|Baseline|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist hand >shoulder/elbow
313020|NCT00237744|B1|Baseline|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.
313021|NCT00237744|P3|Participant Flow|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
313022|NCT00237744|P2|Participant Flow|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
313023|NCT00237744|P1|Participant Flow|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.
313024|NCT00237744|O3|Outcome|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
313025|NCT00237744|O2|Outcome|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
313026|NCT00237744|O1|Outcome|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.
313027|NCT00237744|O3|Outcome|Whole Arm Motor Learning Group|Interventions included whole arm motor learning, FES and Robotics.
313028|NCT00237744|O2|Outcome|Wrist/Hand FES+Whole Arm Motor Learning|The intervention provided in this group included surface FES and whole are motor learning.
313029|NCT00237744|O1|Outcome|Shoulder/Elbow Robotics+Whole Arm Motor Learning|Subjects>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
313030|NCT00237744|E3|Reported Event|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow = wrist hand.
313031|NCT00237744|E2|Reported Event|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.
313032|NCT00237744|E1|Reported Event|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist/hand> shoulder/elbow.)
313033|NCT00237770|B3|Baseline|Total|Total of all reporting groups
313034|NCT00237770|B2|Baseline|Able-bodied Controls|Systolic blood pressure responses to head-up tilt were determined in able-bodied controls following placebo administration
313035|NCT00237770|B1|Baseline|Individuals With Tetraplegia|Systolic blood pressure responses to head-up tilt were determined after placebo, L-NAME (1.0 mg/kg) and L-NAME administration (2.0 mg/kg) administration.
313036|NCT00237770|P2|Participant Flow|Control Subjects|Systolic blood pressure responses to head-up tilt were determined in non-spinal cord injured control subjects following placebo administration. Control subjects visited the laboratory for 1 visit.
313037|NCT00237770|P1|Participant Flow|Tetraplegic Subjects|All tetraplegic subjects underwent a head-up tilt maneuver to determine systolic blood pressure responses to placebo L-NAME 1.0 mg/kg and L-NAME 2.0 mg/kg. Subjects with tetraplegia visited the laboratory on 3 separate occasions.
313038|NCT00237770|O4|Outcome|Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg|Systolic blood pressure responses during head-up tilt were determined following L-NAME administration (2.0 mg/kg)
313039|NCT00237770|O3|Outcome|Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg|Systolic blood pressure responses to head-up tilt were determined following administration of L-NAME (1.0 mg/kg)
313040|NCT00237770|O2|Outcome|Control Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined in non spinal cord injured controls following placebo administration
313041|NCT00237770|O1|Outcome|Tetraplegic Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined after placebo administration in persons with tetraplegia
313042|NCT00237770|E4|Reported Event|Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg|Systolic blood pressure responses during head-up tilt were determined following L-NAME administration (2.0 mg/kg)
313043|NCT00237770|E3|Reported Event|Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg|Systolic blood pressure responses to head-up tilt were determined following administration of L-NAME (1.0 mg/kg)
313044|NCT00237770|E2|Reported Event|Control Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined in non spinal cord injured controls following placebo administration
313045|NCT00237770|E1|Reported Event|Tetraplegic Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined after placebo administration in persons with tetraplegia
313046|NCT00237796|B3|Baseline|Total|Total of all reporting groups
313047|NCT00237796|B2|Baseline|Goal Focused Supportive Contact (GFSC)|Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
328543|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
313048|NCT00237796|B1|Baseline|Cognitive Behavioral Social Skills Training (CBSST)|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
313049|NCT00237796|P2|Participant Flow|Goal Focused Supportive Contact (GFSC)|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
313050|NCT00237796|P1|Participant Flow|Cognitive Behavioral Social Skills Training (CBSST)|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
313051|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
313052|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
313053|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
313054|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
313055|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
313056|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
313057|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
313058|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
313059|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
313060|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
314091|NCT00244101|O1|Outcome|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
313061|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
313062|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
313063|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|"Goal Focused Supportive Contact
Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months."
313064|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
313065|NCT00237796|E2|Reported Event|Goal Directed Supportive Care|Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
313066|NCT00237796|E1|Reported Event|CBSST|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
313067|NCT00237809|B5|Baseline|Total|Total of all reporting groups
313068|NCT00237809|B4|Baseline|Placebo/Control|"Placebo/control
Cognitive retraining : Cog rehab"
313069|NCT00237809|B3|Baseline|D-serine/Cog Rehab|"D-serine/cog rehab
D-serine : D-serine (30 mg/kg)"
313070|NCT00237809|B2|Baseline|Placebo/Cog Rehab|"Placebo/cog rehab
Cognitive retraining : Cog rehab"
313071|NCT00237809|B1|Baseline|D-serine/Control|"D-serine/control
D-serine : D-serine (30 mg/kg)"
313072|NCT00237809|P4|Participant Flow|Placebo Drug/ Placebo CRT|Placebo/control
313073|NCT00237809|P3|Participant Flow|D-serine Drug/CRT|"D-serine/cog rehab
D-serine : D-serine (30 mg/kg)"
313074|NCT00237809|P2|Participant Flow|Placebo Drug /CRT|"Placebo/cog rehab
Cognitive retraining : Cog rehab"
313075|NCT00237809|P1|Participant Flow|D-serine Drug /CRT Placebo|"D-serine/control
D-serine : D-serine (30 mg/kg)"
313076|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control
Cognitive retraining : video"
313077|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab
D-serine : D-serine (30 mg/kg)"
313078|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab
Cognitive retraining : Cog rehab"
313079|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control
D-serine : D-serine (30 mg/kg)"
313080|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control
Cognitive retraining : video"
313081|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab
D-serine : D-serine (30 mg/kg)"
313082|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab
Cognitive retraining : Cog rehab"
313083|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control
D-serine : D-serine (30 mg/kg)"
313084|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control
Cognitive retraining : video"
313085|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab
D-serine : D-serine (30 mg/kg)"
313086|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab
Cognitive retraining : Cog rehab"
313087|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control
D-serine : D-serine (30 mg/kg)"
313088|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control
Cognitive retraining : video"
313089|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab
D-serine : D-serine (30 mg/kg)"
313090|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab
Cognitive retraining : Cog rehab"
313091|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control
D-serine : D-serine (30 mg/kg)"
313092|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control
Cognitive retraining : video"
313094|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab
Cognitive retraining : Cog rehab"
313095|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control
D-serine : D-serine (30 mg/kg)"
313096|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control
Cognitive retraining : video"
313097|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab
D-serine : D-serine (30 mg/kg)"
313098|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab
Cognitive retraining : Cog rehab"
313099|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control
D-serine : D-serine (30 mg/kg)"
313100|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control
Cognitive retraining : video"
313101|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab
D-serine : D-serine (30 mg/kg)"
313102|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab
Cognitive retraining : Cog rehab"
313103|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control
D-serine : D-serine (30 mg/kg)"
313104|NCT00237809|E4|Reported Event|Placebo/Control|"Placebo/control
Cognitive retraining : video"
313105|NCT00237809|E3|Reported Event|D-serine/Cog Rehab|"D-serine/cog rehab
D-serine : D-serine (30 mg/kg)"
313106|NCT00237809|E2|Reported Event|Placebo/Cog Rehab|"Placebo/cog rehab
Cognitive retraining : Cog rehab"
313107|NCT00237809|E1|Reported Event|D-serine/Control|"D-serine/control
D-serine : D-serine (30 mg/kg)"
313108|NCT00238108|B3|Baseline|Total|Total of all reporting groups
313109|NCT00238108|B2|Baseline|Placebo|Placebo
313110|NCT00238108|B1|Baseline|Melatonin|Melatonin
313111|NCT00238108|P2|Participant Flow|Placebo|Placebo
313112|NCT00238108|P1|Participant Flow|Melatonin|Melatonin
313113|NCT00238108|O2|Outcome|Placebo|Placebo
313114|NCT00238108|O1|Outcome|Melatonin|Melatonin
313115|NCT00238108|E2|Reported Event|Placebo|Placebo
313116|NCT00238108|E1|Reported Event|Melatonin|Melatonin
313117|NCT00238121|B3|Baseline|Total|Total of all reporting groups
313118|NCT00238121|B2|Baseline|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313119|NCT00238121|B1|Baseline|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313120|NCT00238121|P2|Participant Flow|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313121|NCT00238121|P1|Participant Flow|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313122|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313123|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313124|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313125|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313126|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313127|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313128|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313129|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
313130|NCT00238121|E1|Reported Event|Sorafenib|
313131|NCT00238238|B4|Baseline|Total|Total of all reporting groups
313132|NCT00238238|B3|Baseline|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
313133|NCT00238238|B2|Baseline|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
313134|NCT00238238|B1|Baseline|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
313135|NCT00238238|P3|Participant Flow|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
313136|NCT00238238|P2|Participant Flow|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
313137|NCT00238238|P1|Participant Flow|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
313138|NCT00238238|O3|Outcome|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
313139|NCT00238238|O2|Outcome|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
313140|NCT00238238|O1|Outcome|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
313141|NCT00238238|O3|Outcome|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
313142|NCT00238238|O2|Outcome|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
313143|NCT00238238|O1|Outcome|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
313144|NCT00238238|E3|Reported Event|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
313145|NCT00238238|E2|Reported Event|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
313146|NCT00238238|E1|Reported Event|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
313147|NCT00238264|B1|Baseline|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
313148|NCT00238264|P1|Participant Flow|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
313149|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
313150|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
313151|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
313152|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
313153|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
313154|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
313155|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
314092|NCT00244101|E3|Reported Event|NCPAP|initial management with bubble nCPAP and selective surfactant treatment
313156|NCT00238264|E1|Reported Event|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
313157|NCT00238303|B4|Baseline|Total|Total of all reporting groups
313158|NCT00238303|B3|Baseline|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313159|NCT00238303|B2|Baseline|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor"
313160|NCT00238303|B1|Baseline|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313161|NCT00238303|P3|Participant Flow|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313162|NCT00238303|P2|Participant Flow|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor"
313163|NCT00238303|P1|Participant Flow|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313164|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313165|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor"
313189|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
313190|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
313166|NCT00238303|O1|Outcome|Stratum 1 Patients That Started Treatment|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313167|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313168|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor"
313169|NCT00238303|O1|Outcome|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313170|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313171|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor"
314093|NCT00244101|E2|Reported Event|Surfactant Extubated to nCPAP|prophylactic surfactant with rapid extubation to bubble nCPAP
313172|NCT00238303|O1|Outcome|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313173|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313174|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor"
313175|NCT00238303|O1|Outcome|Stratum 1 Patients That Started Treatment|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
313176|NCT00238303|E3|Reported Event|Stratum 3 (Not Undergoing Surgery)|vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
313177|NCT00238303|E2|Reported Event|Stratum 2 (Undergoing Surgery)|surgery : Patients undergo surgery to remove tumor
313178|NCT00238303|E1|Reported Event|Stratum 1 (Not Undergoing Surgery)|vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
313179|NCT00238355|B1|Baseline|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours
Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
313180|NCT00238355|P1|Participant Flow|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours
Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
313181|NCT00238355|O1|Outcome|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours
Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
313182|NCT00238355|E1|Reported Event|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours
Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
313183|NCT00238420|B3|Baseline|Total|Total of all reporting groups
313184|NCT00238420|B2|Baseline|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
313185|NCT00238420|B1|Baseline|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
313186|NCT00238420|P2|Participant Flow|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
313187|NCT00238420|P1|Participant Flow|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
313188|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
313191|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
313192|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
313193|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
313194|NCT00238420|E2|Reported Event|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
313195|NCT00238420|E1|Reported Event|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
313196|NCT00238433|B1|Baseline|Busulfan/Melphalan/Thiotepa|"Treatment Plan:
Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Administration Growth Factor: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
313197|NCT00238433|P1|Participant Flow|Busulfan/Melphalan/Thiotepa|"Treatment:
Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Administration Growth Factor: Filgrastim 5mcg/kg intravenous piggyback (IVPB) will be administered beginning on day +5 and continued until absolute neutrophil count (ANC) > 1500 for 2 consecutive days."
313216|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
314333|NCT00245102|O4|Outcome|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
313198|NCT00238433|O1|Outcome|Busulfan/Melphalan/Thiotepa|"Treatment Plan:
Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Administration Growth Factor: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
313199|NCT00238433|O1|Outcome|Busulfan/Melphalan/Thiotepa|"Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Thiotepa: 250 mg/m2/day/iv on days -3 and -2
Procedure/Surgery: bone marrow ablation with stem cell support
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
Growth factor administration: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
313200|NCT00238433|E1|Reported Event|BuMelTT|"*For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
TREATMENT PLAN:
Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Thiotepa: 250 mg/m2/day/iv on days -3 and -2
Procedure/Surgery: bone marrow ablation with stem cell support
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
Growth factor administration: Filgrastim"
313201|NCT00232141|B3|Baseline|Total|Total of all reporting groups
313202|NCT00232141|B2|Baseline|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313203|NCT00232141|B1|Baseline|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313204|NCT00232141|P2|Participant Flow|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313205|NCT00232141|P1|Participant Flow|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313206|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313207|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313208|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313209|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313210|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313211|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313212|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313213|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313214|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313215|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313284|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313217|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313218|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313219|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313220|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313221|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313222|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313223|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313224|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313225|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313226|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313227|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313228|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313229|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313230|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313276|NCT00232180|P2|Participant Flow|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313320|NCT00232479|P1|Participant Flow|Group 1|study group receives taxotere, herceptin and carboplatin in dose dense fashion
313231|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313232|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313233|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313234|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313235|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313236|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313237|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313238|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313239|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313240|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313241|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313242|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313243|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313244|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313245|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313246|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313247|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313248|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313249|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313250|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313251|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313252|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313298|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313321|NCT00232479|O1|Outcome|Group 1|patients received herceptin, carboplatin and taxotere in a dose dense fashion.
313253|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313254|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313255|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313256|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313257|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313258|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313259|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313260|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313261|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313262|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313263|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313264|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313265|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313266|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313267|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313268|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313269|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313270|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
313271|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
313272|NCT00232180|B3|Baseline|Total|Total of all reporting groups
313273|NCT00232180|B2|Baseline|Placebo|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313274|NCT00232180|B1|Baseline|Eplerenone|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313275|NCT00232180|P3|Participant Flow|Eplerenone: Open Label Phase|Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
313277|NCT00232180|P1|Participant Flow|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313278|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313279|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313280|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313281|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313282|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313283|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313285|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313286|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313287|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313288|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313289|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313290|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313291|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313292|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313293|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313294|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313295|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313296|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313297|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313322|NCT00232479|O1|Outcome|Group 1|patients received dose dense herceptin, carboplatin and taxotere
313299|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313300|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313301|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313302|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313303|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313304|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313305|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313306|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313307|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313308|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313309|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313310|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313311|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313312|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313313|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313314|NCT00232180|E5|Reported Event|Eplerenone: Open Label Phase|Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
313315|NCT00232180|E4|Reported Event|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313316|NCT00232180|E3|Reported Event|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heartfailure therapy. Dose might have been increased at Week 4 to 50 mg once daily.For participants with an estimated glomerular filtration rate (eGFR) between 30 to49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initialdose was 25 mg orally once every other day; at Week 4, dose might have beenincreased to a maximum of 25 mg once daily based on serum potassium level.
313317|NCT00232180|E2|Reported Event|Placebo: Double-blind Phase(May 25, 2010 Data Cutoff)|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
313318|NCT00232180|E1|Reported Event|Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off)|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
313319|NCT00232479|B1|Baseline|Group 1|treat with taxotere, herceptin, carboplatin in dose dense fashion
314429|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
313323|NCT00232479|E1|Reported Event|Group 1|patients received herceptin, carboplatin, taxotere in dose dense fashion
313324|NCT00232505|B3|Baseline|Total|Total of all reporting groups
313325|NCT00232505|B2|Baseline|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
carboplatin: Given IV"
313326|NCT00232505|B1|Baseline|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.
cetuximab: Given IV"
313327|NCT00232505|P2|Participant Flow|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
carboplatin: Given IV"
313328|NCT00232505|P1|Participant Flow|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.
cetuximab: Given IV"
313329|NCT00232505|O2|Outcome|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
carboplatin: Given IV"
313330|NCT00232505|O1|Outcome|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.
cetuximab: Given IV"
313331|NCT00232505|O2|Outcome|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
carboplatin: Given IV"
313332|NCT00232505|O1|Outcome|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.
cetuximab: Given IV"
314094|NCT00244101|E1|Reported Event|Prophylactic Surfactant|Prophylactic surfactant followed by mechanical ventilation
313333|NCT00232505|O4|Outcome|Cetuximab and Carboplatin Subset|patients receiving cetuximab and carboplatin who had confirmed basal-like disease by quantitative realtime polymerase chain reaction–based intrinsic subtype assay
313334|NCT00232505|O3|Outcome|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
carboplatin: Given IV"
313335|NCT00232505|O2|Outcome|Cetuximab and Carboplatin After Cetuximab Alone|Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin
313336|NCT00232505|O1|Outcome|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.
cetuximab: Given IV"
313337|NCT00232505|E3|Reported Event|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
carboplatin: Given IV"
313338|NCT00232505|E2|Reported Event|Cetuximab and Carboplatin After Cetuximab Alone|Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin
313339|NCT00232505|E1|Reported Event|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.
cetuximab: Given IV"
313340|NCT00232544|B3|Baseline|Total|Total of all reporting groups
313341|NCT00232544|B2|Baseline|TLC-Control|A TLC system for providing general health education
313342|NCT00232544|B1|Baseline|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
313343|NCT00232544|P2|Participant Flow|TLC-Control|A TLC system for providing general health education
313344|NCT00232544|P1|Participant Flow|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
313345|NCT00232544|O2|Outcome|TLC-Control|A TLC system for providing general health education
313346|NCT00232544|O1|Outcome|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
313347|NCT00232544|O2|Outcome|TLC-Control|A TLC system for providing general health education
313348|NCT00232544|O1|Outcome|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
313349|NCT00232544|E2|Reported Event|TLC-Control|A TLC system for providing general health education
313350|NCT00232544|E1|Reported Event|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
313351|NCT00232557|B3|Baseline|Total|Total of all reporting groups
313352|NCT00232557|B2|Baseline|TLC-health Education|A TLC system for providing general health education
313353|NCT00232557|B1|Baseline|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
313354|NCT00232557|P2|Participant Flow|TLC-health Education|A TLC system for providing general health education
313355|NCT00232557|P1|Participant Flow|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
313356|NCT00232557|O2|Outcome|TLC-health Education|A TLC system for providing general health education
313357|NCT00232557|O1|Outcome|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
313358|NCT00232557|O2|Outcome|TLC-health Education|A TLC system for providing general health education
313359|NCT00232557|O1|Outcome|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
313360|NCT00232557|E2|Reported Event|Arm 2|A TLC system for providing general health education
313566|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
313361|NCT00232557|E1|Reported Event|Arm 1|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
313362|NCT00232583|B3|Baseline|Total|Total of all reporting groups
313363|NCT00232583|B2|Baseline|Metfomin, Pioglitazone & Glyburide|
313364|NCT00232583|B1|Baseline|Metfomin & Insulin|
313365|NCT00232583|P2|Participant Flow|Metfomin, Pioglitazone & Glyburide|
313366|NCT00232583|P1|Participant Flow|Metfomin & Insulin|
313367|NCT00232583|O2|Outcome|Metformin, GLyburide & Pioglitazone|
313368|NCT00232583|O1|Outcome|Metformin & Insulin|
313369|NCT00232583|E2|Reported Event|Metfomin, Pioglitazone & Glyburide|
313370|NCT00232583|E1|Reported Event|Metfomin & Insulin|
313371|NCT00232596|B3|Baseline|Total|Total of all reporting groups
313372|NCT00232596|B2|Baseline|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313373|NCT00232596|B1|Baseline|Placebo - Double-blind (DB) Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313374|NCT00232596|P2|Participant Flow|Retigabine|Titration Phase: retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID with a starting daily dose of 300 mg/day (in 3 equally divided doses). The dose increased weekly by 150 mg/day (50 mg TID) for the 6 weeks of the Titration Phase to a target daily dose of 1200 mg/day (400 mg TID) by the beginning of Week 7 of treatment. Maintenance Phase: Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks in participants who tolerated this dose. Participants who could not tolerate the 1200 mg/day dose were allowed to reduce the dose to 1050 mg/day (350 mg TID) at the end of the first week and then maintain this dose for the remainder of the 12 weeks.
313375|NCT00232596|P1|Participant Flow|Placebo|Titration Phase: matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 6 weeks. Maintenance Phase: matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks.
313376|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313377|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313378|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313379|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313380|NCT00232596|O4|Outcome|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
313381|NCT00232596|O3|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313382|NCT00232596|O2|Outcome|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
313383|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313384|NCT00232596|O4|Outcome|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
313385|NCT00232596|O3|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of the Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of the Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313386|NCT00232596|O2|Outcome|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
313387|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313388|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
328544|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
313389|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313390|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313391|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
313392|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313393|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
313394|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313395|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
313396|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313397|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313398|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313399|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
313400|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313401|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313402|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313403|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313404|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313405|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
313406|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313407|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
313408|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313409|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313410|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313411|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313412|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID), for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313413|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
313596|NCT00241280|E2|Reported Event|Test: Galyfilcon A|Subjects that were randomly assigned to wear Test lens.
328545|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
313414|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313415|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313416|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313417|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
313418|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313419|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313420|NCT00232596|E4|Reported Event|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
313470|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313421|NCT00232596|E3|Reported Event|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of the Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of the Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
313422|NCT00232596|E2|Reported Event|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
313423|NCT00232596|E1|Reported Event|Placebo - Double-blind (DB) Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
313424|NCT00232739|B1|Baseline|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313425|NCT00232739|P1|Participant Flow|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313426|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313427|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313428|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313429|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313430|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313431|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313432|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313433|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313434|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313435|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313436|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313437|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313438|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313439|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313440|NCT00232739|E1|Reported Event|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
313441|NCT00238615|B1|Baseline|Group 1|
313461|NCT00240500|B2|Baseline|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313442|NCT00238615|P1|Participant Flow|Docetaxel / Carboplatin / XRT + Surgical Resection|Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival outcomes.
313443|NCT00238615|O1|Outcome|Docetaxel+Carboplatin +Radiation+Surgery|Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival and progression free survival outcomes.These results are published PMID: 21752720.
313444|NCT00238615|O1|Outcome|Docetaxel / Carboplatin / XRT + Surgical Resection|This planned analysis of gene expression patterns was not performed.
313445|NCT00238615|O1|Outcome|Docetaxel / Carboplatin / XRT + Surgical Resection|"All patients enrolled had combined chemotherapy/radiation followed by surgical resection (other than 1 patient who had only chemotherapy/radiation) and were evaluated for a primary endpoint of 2 year overall survival. PET scans obtained pre and post 5 weeks of combined therapy were analyzed for predictive capacity relative to this endpoint.
Results were published PMID 21774104"
313446|NCT00238615|E1|Reported Event|Docetaxel / Carboplatin / XRT + Surgical Resection|Adverse events for all enrolled patients were followed. Details are published in PMID: 21752720
313447|NCT00240487|B3|Baseline|Total|Total of all reporting groups
313505|NCT00240526|O3|Outcome|ENGERIX 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
313448|NCT00240487|B2|Baseline|Delayed Nitric Oxide|Subjects received no intervention (no nitric oxide) for the first 4 hours of study participation. After which, they received 10 ppm nitric oxide for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.
313449|NCT00240487|B1|Baseline|Nitric Oxide First|Subjects received 10 ppm nitric oxide for the first 4 hours of study participation After which, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.
313450|NCT00240487|P2|Participant Flow|Delayed Nitric Oxide|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
313451|NCT00240487|P1|Participant Flow|Nitric Oxide First|Subjects who were randomized to receive Nitric Oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the initial 8 hours of study participation, subjects remained on whichever intervention (no intervention versus 10 ppm nitric oxide) they responded best to.
313452|NCT00240487|O2|Outcome|Delayed Nitric Oxide Treatment|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
313453|NCT00240487|O1|Outcome|Immediate Nitric Oxide Treatment|Subjects who were randomized to receive immediate treatment with nitric oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects received treatment standard clinical care. Blood gases were monitored once an hour for 4 hours.
313454|NCT00240487|E2|Reported Event|Delayed Treatment With Nitric Oxide|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
313455|NCT00240487|E1|Reported Event|Immediate Treatment With Nitric Oxide|Subjects who were randomized to receive immediate treatment with nitric oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours.
313456|NCT00240500|B7|Baseline|Total|Total of all reporting groups
313457|NCT00240500|B6|Baseline|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313458|NCT00240500|B5|Baseline|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313459|NCT00240500|B4|Baseline|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313460|NCT00240500|B3|Baseline|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313462|NCT00240500|B1|Baseline|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313463|NCT00240500|P6|Participant Flow|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313464|NCT00240500|P5|Participant Flow|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313465|NCT00240500|P4|Participant Flow|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313466|NCT00240500|P3|Participant Flow|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313467|NCT00240500|P2|Participant Flow|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313468|NCT00240500|P1|Participant Flow|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313469|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313745|NCT00242216|O2|Outcome|Fosamprenavir|
313746|NCT00242216|O1|Outcome|Atazanavir|
313471|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313472|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313473|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313474|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313475|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313476|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313477|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313478|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313479|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313480|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313481|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313482|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313483|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313484|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313485|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
313486|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
313487|NCT00240526|B5|Baseline|Total|Total of all reporting groups
313488|NCT00240526|B4|Baseline|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
313489|NCT00240526|B3|Baseline|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
313490|NCT00240526|B2|Baseline|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313491|NCT00240526|B1|Baseline|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313492|NCT00240526|P4|Participant Flow|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
313493|NCT00240526|P3|Participant Flow|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
313597|NCT00241280|E1|Reported Event|Control: Etafilcon A|Subjects that were randomly assigned to wear Control lens.
313494|NCT00240526|P2|Participant Flow|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313495|NCT00240526|P1|Participant Flow|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313496|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
313497|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
313498|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313499|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313500|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
313501|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
313502|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313503|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313504|NCT00240526|O4|Outcome|ENGERIX 3D GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
313747|NCT00242216|E2|Reported Event|Fosamprenavir|
313506|NCT00240526|O2|Outcome|ENGERIX 3D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313507|NCT00240526|O1|Outcome|ENGERIX 4D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313508|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
313509|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
313510|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313511|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313512|NCT00240526|O4|Outcome|ENGERIX 3D GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
313513|NCT00240526|O3|Outcome|ENGERIX 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
313514|NCT00240526|O2|Outcome|ENGERIX 3D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313515|NCT00240526|O1|Outcome|ENGERIX 4D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313516|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
313517|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
313518|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313519|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313520|NCT00240526|E4|Reported Event|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
313521|NCT00240526|E3|Reported Event|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
313522|NCT00240526|E2|Reported Event|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313523|NCT00240526|E1|Reported Event|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
313524|NCT00240539|B5|Baseline|Total|Total of all reporting groups
313525|NCT00240539|B4|Baseline|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
313526|NCT00240539|B3|Baseline|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
313527|NCT00240539|B2|Baseline|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
313528|NCT00240539|B1|Baseline|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
313529|NCT00240539|P4|Participant Flow|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
313530|NCT00240539|P3|Participant Flow|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
313531|NCT00240539|P2|Participant Flow|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
313598|NCT00241358|B4|Baseline|Total|Total of all reporting groups
313532|NCT00240539|P1|Participant Flow|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
313533|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
313534|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
313535|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
313536|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
313537|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
313538|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
313539|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
313540|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
313541|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
313542|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
313748|NCT00242216|E1|Reported Event|Atazanavir|
314095|NCT00244140|B3|Baseline|Total|Total of all reporting groups
313543|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
313544|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
313545|NCT00240539|E4|Reported Event|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
313546|NCT00240539|E3|Reported Event|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
313547|NCT00240539|E2|Reported Event|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
313548|NCT00240539|E1|Reported Event|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
313549|NCT00240981|B3|Baseline|Total|Total of all reporting groups
313550|NCT00240981|B2|Baseline|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
313551|NCT00240981|B1|Baseline|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
313552|NCT00240981|P2|Participant Flow|Placebo|
313553|NCT00240981|P1|Participant Flow|Treatment|
313554|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
313555|NCT00240981|O1|Outcome|Testosterone|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
313556|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
313557|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
313558|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
313559|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
313560|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
313561|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
313562|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
313563|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
313564|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
313565|NCT00240981|O1|Outcome|Testosterone|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
328546|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
313567|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
313568|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
313569|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
313570|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
313571|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
313572|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
313573|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
313574|NCT00240981|E2|Reported Event|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
314334|NCT00245102|O3|Outcome|Leiomyosarcoma|Sorafenib 400 mg PO BID
313575|NCT00240981|E1|Reported Event|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
313576|NCT00240994|B1|Baseline|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
313577|NCT00240994|P1|Participant Flow|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
313578|NCT00240994|O1|Outcome|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
313579|NCT00240994|E1|Reported Event|Alemtuzumab (Campath)|In this open-label, single-arm trial , participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
313580|NCT00241176|B1|Baseline|Sample|Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
313581|NCT00241176|P1|Participant Flow|Aripiprazole|Subjects received initial dose based on body weight at Visit 2: Subjects between 25-50 kg were started on 1.25 mg/day, Subjects between 50-70 kg were started on 2.5 mg/day, Subjects greater than 70 kg were started on 5 mg/day. Dosage was titrated at Visit 3, 5, 6, or 7 based on YGTSS and CGI-TS ratings at the discretion of the investigator. Subjects who showed evidence of response (reduction in CGI-TS by 1-2 points)remained on the same dose. Subjects who did not show evidence of response could be increased: Subjects between 25-50 kg were could be increased 1.25 mg/day at each titration visit, Subjects between 50-70 kg could be increased 2.5 mg/day at each titration visit, and Subjects greater than 70 kg could be increased 5 mg/day at each titration visit.
313582|NCT00241176|O2|Outcome|Group 1 - Endpoint|Sample of children and adolescents that enrolled in study to receive active medication at endpoint prior to down titration.
313583|NCT00241176|O1|Outcome|Group 1 - Baseline|Sample of children and adolescents that enrolled in study to receive active medication at baseline.
313584|NCT00241176|O2|Outcome|Group 1 - Endpoint|Sample of children and adolescents that enrolled in study to receive active medication at endpoint prior to down titration.
313585|NCT00241176|O1|Outcome|Group 1 - Baseline|Sample of children and adolescents that enrolled in study to receive active medication at baseline.
313586|NCT00241176|E1|Reported Event|Sample|Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
313587|NCT00241280|B3|Baseline|Total|Total of all reporting groups
313588|NCT00241280|B2|Baseline|Test: Galyfilcon A|Subjects that were randomized to receive the Test lens galyfilcon A
313589|NCT00241280|B1|Baseline|Control: Etafilcon A|Subjects that were randomized to receive the Control lens etafilcon A
313590|NCT00241280|P2|Participant Flow|Test: Galyfilcon A|Subjects that were randomly assigned to wear the Test lens.
313591|NCT00241280|P1|Participant Flow|Control: Etafilcon A|Subjects that were randomly assigned to wear Control lens.
313592|NCT00241280|O2|Outcome|Test: Galyfilcon A|Subjects that were randomly assigned to wear the Test lens.
313593|NCT00241280|O1|Outcome|Control: Etafilcon A|Subjects that were randomly assigned to wear the Control lens.
313594|NCT00241280|O2|Outcome|Test: Galyfilcon A|"Subjects that were randomly assigned to wear the Test lens.
It was reported that for one subject eye, that the contact lens was dirty during the visual acuity testing."
313595|NCT00241280|O1|Outcome|Control: Etafilcon A|Subjects that were randomly assigned to wear the Control lens.
328547|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
313599|NCT00241358|B3|Baseline|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313600|NCT00241358|B2|Baseline|Recipients|"Conditioning Regimen
Cyclophosphamide 60mg/kg/day on Days -3 and -2
TBI 550cGy on Day -1
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
PBSC transplant on Day 0"
313601|NCT00241358|B1|Baseline|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313602|NCT00241358|P3|Participant Flow|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313603|NCT00241358|P2|Participant Flow|Recipients|"Conditioning Regimen
Cyclophosphamide 60mg/kg/day on Days -3 and -2
TBI 550cGy on Day -1
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
PBSC transplant on Day 0"
313604|NCT00241358|P1|Participant Flow|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313605|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313606|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen
Cyclophosphamide 60mg/kg/day on Days -3 and -2
TBI 550cGy on Day -1
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
PBSC transplant on Day 0"
313607|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313608|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313609|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen
Cyclophosphamide 60mg/kg/day on Days -3 and -2
TBI 550cGy on Day -1
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
PBSC transplant on Day 0"
313610|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313611|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313612|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen
Cyclophosphamide 60mg/kg/day on Days -3 and -2
TBI 550cGy on Day -1
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
PBSC transplant on Day 0"
313613|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313614|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313615|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen
Cyclophosphamide 60mg/kg/day on Days -3 and -2
TBI 550cGy on Day -1
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
PBSC transplant on Day 0"
313616|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313617|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313618|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen
Cyclophosphamide 60mg/kg/day on Days -3 and -2
TBI 550cGy on Day -1
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
PBSC transplant on Day 0"
313619|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313620|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313621|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen
Cyclophosphamide 60mg/kg/day on Days -3 and -2
TBI 550cGy on Day -1
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
PBSC transplant on Day 0"
313622|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313623|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313669|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313624|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen
Cyclophosphamide 60mg/kg/day on Days -3 and -2
TBI 550cGy on Day -1
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
PBSC transplant on Day 0"
313625|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313626|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313627|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen
Cyclophosphamide 60mg/kg/day on Days -3 and -2
TBI 550cGy on Day -1
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
PBSC transplant on Day 0"
313628|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313629|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313630|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen
Cyclophosphamide 60mg/kg/day on Days -3 and -2
TBI 550cGy on Day -1
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
PBSC transplant on Day 0"
314335|NCT00245102|O2|Outcome|MPNST|Sorafenib 400 mg PO BID
313631|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
313632|NCT00241358|E2|Reported Event|Recipients|Stem Cell Transplantation Day 0
313633|NCT00241358|E1|Reported Event|Donors|AMD3100 SC 240 ug/kg/actual donor weight on Day 1 and possibly Day 3
313634|NCT00241644|B5|Baseline|Total|Total of all reporting groups
313635|NCT00241644|B4|Baseline|Rotarix Pooled Group|Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
313636|NCT00241644|B3|Baseline|Placebo Group|Subjects received 3 doses of placebo.
313637|NCT00241644|B2|Baseline|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313638|NCT00241644|B1|Baseline|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313639|NCT00241644|P4|Participant Flow|Rotarix Pooled Group|Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
313640|NCT00241644|P3|Participant Flow|Placebo Group|Subjects received 3 doses of placebo.
313641|NCT00241644|P2|Participant Flow|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313642|NCT00241644|P1|Participant Flow|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313643|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313644|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313645|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313646|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313647|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313648|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313649|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313650|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313651|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313652|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313653|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313654|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313655|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313656|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313657|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313658|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313659|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313660|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313661|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313662|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313663|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313664|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313665|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313666|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313667|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313668|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313670|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313671|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313672|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313673|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313674|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313675|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313676|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313677|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313678|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313679|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313680|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313681|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313682|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313683|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313684|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313685|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313686|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313687|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313688|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313689|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313690|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313691|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313692|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313693|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313694|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313695|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313696|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313697|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313698|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313699|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313700|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313701|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313702|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313703|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313704|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313705|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313706|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313707|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313708|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313709|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313710|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313711|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313712|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313713|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313714|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313715|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
313716|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313717|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313718|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313719|NCT00241644|E4|Reported Event|Placebo Group|Subjects received 3 doses of placebo.
313782|NCT00242567|P1|Participant Flow|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
313720|NCT00241644|E3|Reported Event|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
313721|NCT00241644|E2|Reported Event|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
313722|NCT00241644|E1|Reported Event|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
313723|NCT00241839|B3|Baseline|Total|Total of all reporting groups
313724|NCT00241839|B2|Baseline|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, a Placebo, having the same appearance and dosage label(300mg)as allopurinol, was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional placebo (300mg)was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313725|NCT00241839|B1|Baseline|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313850|NCT00242658|O2|Outcome|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
313726|NCT00241839|P2|Participant Flow|B(Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, a Placebo, having the same appearance and dosage label(300mg)as allopurinol, was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional placebo (300mg)was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313727|NCT00241839|P1|Participant Flow|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313728|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313729|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313730|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313731|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313732|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313733|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313734|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313735|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313736|NCT00241839|E2|Reported Event|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313737|NCT00241839|E1|Reported Event|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
313738|NCT00242216|B3|Baseline|Total|Total of all reporting groups
313739|NCT00242216|B2|Baseline|Fosamprenavir|
313740|NCT00242216|B1|Baseline|Atazanavir|
313741|NCT00242216|P2|Participant Flow|Fosamprenavir|Fosamprenavir/ritonavir (1400mg/100mg) once daily
313742|NCT00242216|P1|Participant Flow|Atazanavir|Atazanavir/ritonavir (300mg/100mg) once daily
313743|NCT00242216|O2|Outcome|Fosamprenavir|
313744|NCT00242216|O1|Outcome|Atazanavir|
313749|NCT00242385|B1|Baseline|Subjects With Severe Congenital α1-PI Deficiency|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
313750|NCT00242385|P2|Participant Flow|ARALAST Then ARALAST Fr. IV-1|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
313751|NCT00242385|P1|Participant Flow|ARALAST Fr. IV-1 Then Aralast|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
313752|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
313753|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
313754|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
313755|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
313756|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
313757|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
313758|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
313759|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
313760|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
313761|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
313762|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
313763|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
313764|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
313765|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
313766|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
313767|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
313768|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
313769|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
313770|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
313771|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
313772|NCT00242385|E2|Reported Event|ARALAST|Subjects received a single dose of ARALAST 60 mg/kg at 0.2 mL/kg/min
313773|NCT00242385|E1|Reported Event|ARALAST Fr. IV-1|Subjects received a single dose of ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min
313774|NCT00242502|B1|Baseline|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
313775|NCT00242502|P1|Participant Flow|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
313776|NCT00242502|O1|Outcome|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
313777|NCT00242502|E1|Reported Event|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
313778|NCT00242567|B3|Baseline|Total|Total of all reporting groups
313779|NCT00242567|B2|Baseline|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
313780|NCT00242567|B1|Baseline|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
313781|NCT00242567|P2|Participant Flow|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
313783|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
313784|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
313785|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
313786|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
313787|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
313788|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
313789|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
313790|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
314096|NCT00244140|B2|Baseline|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
314097|NCT00244140|B1|Baseline|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
313791|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
313792|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
313793|NCT00242567|E4|Reported Event|Delayed Group (Zometa)|Delayed Group (Zometa)
313794|NCT00242567|E3|Reported Event|Delayed Group (No Zometa)|Delayed Group (No Zometa)
313795|NCT00242567|E2|Reported Event|Delayed Group (Overall)|Delayed Group (Overall)
313796|NCT00242567|E1|Reported Event|Early Group|Early Group
313797|NCT00242580|B4|Baseline|Total|Total of all reporting groups
313798|NCT00242580|B3|Baseline|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
313799|NCT00242580|B2|Baseline|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313800|NCT00242580|B1|Baseline|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313801|NCT00242580|P3|Participant Flow|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
313802|NCT00242580|P2|Participant Flow|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313803|NCT00242580|P1|Participant Flow|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313804|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
313839|NCT00242632|P2|Participant Flow|apoE-e4+|Subjects with the apoE-e4 allele
313840|NCT00242632|P1|Participant Flow|apoE-e4-|Subjects without the apoE-e4 allele
313805|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313806|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313849|NCT00242658|P1|Participant Flow|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
314336|NCT00245102|O1|Outcome|Angiosarcoma|Sorafenib 400 mg PO BID
313807|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
313808|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313809|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313810|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
313811|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313812|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313813|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
313814|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313815|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313841|NCT00242632|O1|Outcome|T1-T2|This arm includes all 22 subjects from Time 1 to Time 2, a 6-month period.
313842|NCT00242632|O1|Outcome|T1-T2|This arm includes all 22 subjects from Time 1 to Time 2, a 6-month period.
313843|NCT00242632|E2|Reported Event|ApoE-e4-|This includes the 11 subjects who were non-carriers of the ApoE-e4 allele.
313816|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
313817|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313818|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313819|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
313820|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313821|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313822|NCT00242580|E3|Reported Event|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
313823|NCT00242580|E2|Reported Event|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313824|NCT00242580|E1|Reported Event|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
313825|NCT00242619|B3|Baseline|Total|Total of all reporting groups
313826|NCT00242619|B2|Baseline|Drop-Outs|Subjects who met all criteria, took rosiglitazone, and did not complete the study.
313827|NCT00242619|B1|Baseline|Completers|Subjects who met all criteria, took rosiglitazone, and completed the study.
313828|NCT00242619|P2|Participant Flow|Drop-Outs|Subjects who dropped out and did not complete the 12 weeks on rosiglitazone.
313829|NCT00242619|P1|Participant Flow|Completers|Subjects who completed the study and 12 weeks of taking rosiglitazone.
313830|NCT00242619|O2|Outcome|Drop-Outs|Subjects who dropped out and did not complete the 12 weeks on rosiglitazone.
313831|NCT00242619|O1|Outcome|Completers|Subjects who completed the study and 12 weeks of taking rosiglitazone.
313832|NCT00242619|O2|Outcome|Drop-Outs|Subjects who dropped out of the study.
313833|NCT00242619|O1|Outcome|Completers|Subjects who completed the study.
313834|NCT00242619|E2|Reported Event|Drop-Outs|Subjects who met all criteria, took rosiglitazone, and did not complete the study.
313835|NCT00242619|E1|Reported Event|Completers|Subjects who met all criteria, took rosiglitazone, and completed the study.
313836|NCT00242632|B3|Baseline|Total|Total of all reporting groups
313837|NCT00242632|B2|Baseline|apoE-e4+|Subjects with the apoE-e4 allele
313838|NCT00242632|B1|Baseline|apoE-e4-|Subjects without the apoE-e4 allele
313844|NCT00242632|E1|Reported Event|ApoE-e4+|This includes the 11 subjects who were carriers of the ApoE-e4 allele.
313845|NCT00242658|B3|Baseline|Total|Total of all reporting groups
313846|NCT00242658|B2|Baseline|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
313847|NCT00242658|B1|Baseline|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
313848|NCT00242658|P2|Participant Flow|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
314337|NCT00245102|E6|Reported Event|Other Histology|Sorafenib 400 mg PO BID
313851|NCT00242658|O1|Outcome|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
313852|NCT00242658|O2|Outcome|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
313853|NCT00242658|O1|Outcome|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
313854|NCT00242658|E2|Reported Event|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
313855|NCT00242658|E1|Reported Event|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
313856|NCT00242684|B1|Baseline|Transitional Care Unit Veterans|older patients admitted to a TCU unit
313857|NCT00242684|P1|Participant Flow|Transitional Care Unit Veterans|older patients admitted to a TCU unit
313858|NCT00242684|O1|Outcome|Transitional Care Unit Veterans|older patients admitted to a TCU unit
313859|NCT00242684|O1|Outcome|Transitional Care Unit Veterans|older patients admitted to a TCU unit
313860|NCT00242684|E1|Reported Event|Transitional Care Unit Veterans|older patients admitted to a TCU unit
313861|NCT00242710|B5|Baseline|Total|Total of all reporting groups
313862|NCT00242710|B4|Baseline|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313863|NCT00242710|B3|Baseline|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313864|NCT00242710|B2|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313865|NCT00242710|B1|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313866|NCT00242710|P4|Participant Flow|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313867|NCT00242710|P3|Participant Flow|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313868|NCT00242710|P2|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313927|NCT00235989|P2|Participant Flow|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
313869|NCT00242710|P1|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313870|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313871|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313872|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
314098|NCT00244140|P2|Participant Flow|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
313873|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313874|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313875|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313876|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313877|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313878|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313879|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313880|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313881|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313882|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313883|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313884|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313885|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313928|NCT00235989|P1|Participant Flow|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
328548|NCT00296374|O3|Outcome|Atorvastatin 80 mg|
313886|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313887|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313888|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313889|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313890|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313891|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313892|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313893|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313894|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313895|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313896|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313897|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313898|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313899|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313900|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313901|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313902|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313929|NCT00235989|O4|Outcome|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
313930|NCT00235989|O3|Outcome|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
313903|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313904|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313905|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313906|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313907|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313908|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313909|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313910|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313911|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313912|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313913|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313914|NCT00242710|E4|Reported Event|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313915|NCT00242710|E3|Reported Event|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313916|NCT00242710|E2|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
313917|NCT00242710|E1|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
313918|NCT00235989|B5|Baseline|Total|Total of all reporting groups
313919|NCT00235989|B4|Baseline|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
313920|NCT00235989|B3|Baseline|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
313921|NCT00235989|B2|Baseline|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
313922|NCT00235989|B1|Baseline|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
313923|NCT00235989|P6|Participant Flow|CT: IFNB-1b 500mcg|Core Treatment 500 mcg
313924|NCT00235989|P5|Participant Flow|CT: IFNB-1b 250mcg|Core Treatment 250 mcg
313925|NCT00235989|P4|Participant Flow|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
313926|NCT00235989|P3|Participant Flow|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
313931|NCT00235989|O2|Outcome|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
313932|NCT00235989|O1|Outcome|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
313933|NCT00235989|O4|Outcome|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
313934|NCT00235989|O3|Outcome|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
313935|NCT00235989|O2|Outcome|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
313936|NCT00235989|O1|Outcome|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
313937|NCT00235989|E4|Reported Event|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
313938|NCT00235989|E3|Reported Event|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
313939|NCT00235989|E2|Reported Event|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
313940|NCT00235989|E1|Reported Event|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
313941|NCT00243022|B3|Baseline|Total|Total of all reporting groups
313942|NCT00243022|B2|Baseline|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally"
314099|NCT00244140|P1|Participant Flow|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
313943|NCT00243022|B1|Baseline|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
cyanocobalamin : 50 ug/day given orally
Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
313944|NCT00243022|P2|Participant Flow|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/day given orally"
313945|NCT00243022|P1|Participant Flow|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
cyanocobalamin : 50 ug/day given orally
Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
313946|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally"
313947|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
cyanocobalamin : 50 ug/day given orally
Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
313948|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally"
313949|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
cyanocobalamin : 50 ug/day given orally
Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
313950|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally"
313951|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
cyanocobalamin : 50 ug/day given orally
Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
313952|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally"
313953|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
cyanocobalamin : 50 ug/day given orally
Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
313954|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally"
313955|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
cyanocobalamin : 50 ug/day given orally
Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
313956|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally"
313957|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
cyanocobalamin : 50 ug/day given orally
Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
313958|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally"
313959|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
cyanocobalamin : 50 ug/day given orally
Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
313960|NCT00243022|E2|Reported Event|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally"
313961|NCT00243022|E1|Reported Event|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
cyanocobalamin : 50 ug/day given orally
Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
313962|NCT00243061|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
313963|NCT00243061|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
313964|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally"
313965|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally"
313966|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally"
313967|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally"
314100|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
313968|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally"
313969|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
313970|NCT00243061|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
313971|NCT00243074|B1|Baseline|AZD2171|
313972|NCT00243074|P1|Participant Flow|AZD2171 (Cediranib Maleate)|
313973|NCT00243074|O1|Outcome|AZD2171 (Cediranib Maleate)|
313974|NCT00243074|O1|Outcome|AZD2171|
313975|NCT00243074|O1|Outcome|AZD2171|
313976|NCT00243074|O1|Outcome|AZD2171|
313977|NCT00243074|O1|Outcome|AZD2171|
313978|NCT00243074|O1|Outcome|AZD2171 (Cediranib Maleate)|
313979|NCT00243074|E1|Reported Event|AZD2171|
313980|NCT00243191|B1|Baseline|Imatinib|
313981|NCT00243191|P1|Participant Flow|Imatinib|
313982|NCT00243191|O1|Outcome|Imatinib|
313983|NCT00243191|E1|Reported Event|Imatinib|
313984|NCT00243243|B3|Baseline|Total|Total of all reporting groups
313985|NCT00243243|B2|Baseline|Control|
313986|NCT00243243|B1|Baseline|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
313987|NCT00243243|P2|Participant Flow|Control- Placebo|Intravenous infusion of a placebo
313988|NCT00243243|P1|Participant Flow|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
313989|NCT00243243|O2|Outcome|Control- Placebo|Intravenous infusion of a placebo
313990|NCT00243243|O1|Outcome|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
313991|NCT00243243|E2|Reported Event|Control|
313992|NCT00243243|E1|Reported Event|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
313993|NCT00243269|B5|Baseline|Total|Total of all reporting groups
313994|NCT00243269|B4|Baseline|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.
Patients received the same expectancy-enhancing CD given to patients in Arm 3."
313995|NCT00243269|B3|Baseline|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.
Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
313996|NCT00243269|B2|Baseline|Active Handout and Control Tape.|"Patients received two acupressure bands.
Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.
Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
313997|NCT00243269|B1|Baseline|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
313998|NCT00243269|P4|Participant Flow|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.
Patients received the same expectancy-enhancing CD given to patients in Arm 3."
313999|NCT00243269|P3|Participant Flow|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.
Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
314025|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314026|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314338|NCT00245102|E5|Reported Event|Fibrosarcoma|Sorafenib 400 mg PO BID
314000|NCT00243269|P2|Participant Flow|Active Handout and Control Tape.|"Patients received two acupressure bands.
Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.
Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
314001|NCT00243269|P1|Participant Flow|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
314002|NCT00243269|O4|Outcome|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.
Patients received the same expectancy-enhancing CD given to patients in Arm 3."
314003|NCT00243269|O3|Outcome|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.
Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
314004|NCT00243269|O2|Outcome|Active Handout and Control Tape.|"Patients received two acupressure bands.
Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.
Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
314005|NCT00243269|O1|Outcome|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
314006|NCT00243269|O4|Outcome|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.
Patients received the same expectancy-enhancing CD given to patients in Arm 3."
314007|NCT00243269|O3|Outcome|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.
Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
314008|NCT00243269|O2|Outcome|Active Handout and Control Tape.|"Patients received two acupressure bands.
Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.
Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
328549|NCT00296374|O2|Outcome|Rosuvastatin 40 mg|
314027|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314028|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
315877|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
314009|NCT00243269|O1|Outcome|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
314010|NCT00243269|E4|Reported Event|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.
Patients received the same expectancy-enhancing CD given to patients in Arm 3."
314011|NCT00243269|E3|Reported Event|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.
Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
314012|NCT00243269|E2|Reported Event|Active Handout and Control Tape.|"Patients received two acupressure bands.
Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.
Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
314013|NCT00243269|E1|Reported Event|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
314014|NCT00243919|B4|Baseline|Total|Total of all reporting groups
314015|NCT00243919|B3|Baseline|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314016|NCT00243919|B2|Baseline|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314017|NCT00243919|B1|Baseline|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314018|NCT00243919|P3|Participant Flow|Home Exercise Program|Home Exercise Program (HEP) was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314019|NCT00243919|P2|Participant Flow|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314020|NCT00243919|P1|Participant Flow|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314021|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314022|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314023|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314024|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314084|NCT00244101|B2|Baseline|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
314029|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314030|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314031|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314032|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314033|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314034|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314035|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314036|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314037|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314038|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314039|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314040|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314041|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314042|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314043|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314044|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314045|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314046|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314047|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314048|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314049|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314050|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314090|NCT00244101|O2|Outcome|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
314339|NCT00245102|E4|Reported Event|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
314051|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314052|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314053|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314054|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314055|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314056|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314057|NCT00243919|E3|Reported Event|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
314058|NCT00243919|E2|Reported Event|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
314059|NCT00243919|E1|Reported Event|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
314060|NCT00243932|B4|Baseline|Total|Total of all reporting groups
314061|NCT00243932|B3|Baseline|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
314062|NCT00243932|B2|Baseline|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
314063|NCT00243932|B1|Baseline|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
314064|NCT00243932|P3|Participant Flow|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
314065|NCT00243932|P2|Participant Flow|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
314066|NCT00243932|P1|Participant Flow|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
314067|NCT00243932|O3|Outcome|1,800 mg CoQ10|35 patients. Mean and SD are presented but this group was not included in the efficacy analysis because the 1,800 mg dose was discontinued after stage 1.
314068|NCT00243932|O2|Outcome|Placebo|40 new subjects plus 35 subjects from stage 1 receiving placebo - total 75.
314069|NCT00243932|O1|Outcome|2700mg CoQ10|"40 new subjects and 35 subjects from stage 1 all taking 2,700mg CoQ10 - total 75.
Stage 1 - 35 participants per group compared CoQ10 doses of 1,800mg and 2,700 mg/day and placebo."
314070|NCT00243932|E3|Reported Event|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
314071|NCT00243932|E2|Reported Event|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
314072|NCT00243932|E1|Reported Event|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
314073|NCT00244010|B3|Baseline|Total|Total of all reporting groups
314074|NCT00244010|B2|Baseline|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
314075|NCT00244010|B1|Baseline|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
314076|NCT00244010|P2|Participant Flow|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
314077|NCT00244010|P1|Participant Flow|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
314078|NCT00244010|O2|Outcome|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
314079|NCT00244010|O1|Outcome|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
314080|NCT00244010|E2|Reported Event|Donor|Donors were not assessed for adverse events.
314081|NCT00244010|E1|Reported Event|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
314082|NCT00244101|B4|Baseline|Total|Total of all reporting groups
314083|NCT00244101|B3|Baseline|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
314085|NCT00244101|B1|Baseline|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
314086|NCT00244101|P3|Participant Flow|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
314087|NCT00244101|P2|Participant Flow|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
314088|NCT00244101|P1|Participant Flow|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
314089|NCT00244101|O3|Outcome|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
314340|NCT00245102|E3|Reported Event|Leiomyosarcoma|Sorafenib 400 mg PO BID
314105|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
314106|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
314107|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
314108|NCT00244140|E2|Reported Event|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
314109|NCT00244140|E1|Reported Event|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
314110|NCT00244374|B1|Baseline|All Participants|Participants in pre-randomization cross-sectional study
314111|NCT00244374|P5|Participant Flow|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
314112|NCT00244374|P4|Participant Flow|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
314113|NCT00244374|P3|Participant Flow|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
314114|NCT00244374|P2|Participant Flow|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
314115|NCT00244374|P1|Participant Flow|Cross-sectional/Screening|Cross-sectional screening to determine eligibility for vaccine adherence trial
314116|NCT00244374|O1|Outcome|Screening Study Participants|Participants enrolled in the pre-randomization cross-sectional screening study completed a 60-minute survey, received client-centered risk reduction counseling, and underwent phlebotomy for viral testing. Participants were invited to return one week later for viral testing results, counseling, referrals, and subsequent enrollment in the vaccine adherence cohort study, if eligible.
314117|NCT00244374|O1|Outcome|Cross-sectional Study Participants|Participants enrolled in the pre-randomization cross-sectional screening study completed a 60-minute survey, received client-centered risk reduction counseling, and underwent phlebotomy for viral testing. Participants were invited to return one week later for viral testing results, counseling, referrals, and subsequent enrollment in the vaccine adherence cohort study, if eligible.
314118|NCT00244374|O2|Outcome|Did Not Travel in the Prior 3 Months|"Participants who answered no when asked if they had been on the road or traveling outside of San Francisco in the prior 3 months, or whose last 3 travel destinations within 30 miles of San Francisco"
314119|NCT00244374|O1|Outcome|Traveled in the Prior 3 Months|"Participants who answered yes when asked if they had been on the road or traveling outside of San Francisco in the prior 3 months, and whose last 3 travel destinations were at least 30 miles from San Francisco"
314120|NCT00244374|O2|Outcome|Anti-HCV Negative|Participants tested negative for Hepatitis C Virus (HCV) antibody
314121|NCT00244374|O1|Outcome|Anti-HCV Positive|Participants tested positive for Hepatitis C Virus (HCV) antibody
314122|NCT00244374|O4|Outcome|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
314123|NCT00244374|O3|Outcome|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
314124|NCT00244374|O2|Outcome|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
314171|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314125|NCT00244374|O1|Outcome|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
314126|NCT00244374|E4|Reported Event|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
314127|NCT00244374|E3|Reported Event|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
314128|NCT00244374|E2|Reported Event|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
314129|NCT00244374|E1|Reported Event|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
314130|NCT00244621|B4|Baseline|Total|Total of all reporting groups
314131|NCT00244621|B3|Baseline|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
314132|NCT00244621|B2|Baseline|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
314133|NCT00244621|B1|Baseline|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
314134|NCT00244621|P3|Participant Flow|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
314135|NCT00244621|P2|Participant Flow|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
314136|NCT00244621|P1|Participant Flow|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
314137|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
314138|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
314139|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
314140|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
314141|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
314142|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
314341|NCT00245102|E2|Reported Event|MPNST|Sorafenib 400 mg PO BID
314143|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
314144|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
314145|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
314146|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
314147|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
314148|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
314149|NCT00244621|E3|Reported Event|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
314150|NCT00244621|E2|Reported Event|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
314151|NCT00244621|E1|Reported Event|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
314152|NCT00244712|B3|Baseline|Total|Total of all reporting groups
314153|NCT00244712|B2|Baseline|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314154|NCT00244712|B1|Baseline|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314155|NCT00244712|P2|Participant Flow|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314156|NCT00244712|P1|Participant Flow|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314157|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314158|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314159|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314160|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314161|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314162|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314163|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314164|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314165|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314166|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314167|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314168|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314169|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314170|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314172|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314173|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314174|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314175|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314176|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314177|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314178|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314179|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314180|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314181|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314182|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314183|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314184|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314185|NCT00244712|E2|Reported Event|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
314186|NCT00244712|E1|Reported Event|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
314187|NCT00244725|B5|Baseline|Total|Total of all reporting groups
314342|NCT00245102|E1|Reported Event|Angiosarcoma|Sorafenib 400 mg PO BID
314188|NCT00244725|B4|Baseline|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314189|NCT00244725|B3|Baseline|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314190|NCT00244725|B2|Baseline|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314191|NCT00244725|B1|Baseline|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314192|NCT00244725|P4|Participant Flow|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target International Normalized Ratio (INR) of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314193|NCT00244725|P3|Participant Flow|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314194|NCT00244725|P2|Participant Flow|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314195|NCT00244725|P1|Participant Flow|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil modified release (MR) 250 mg tablet at every 12 hours interval (Q12h)for the duration of 10 ± 2 days of double-blind treatment period.
314196|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314197|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314198|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314199|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314200|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314201|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314202|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314203|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314204|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314205|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314206|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
328550|NCT00296374|O1|Outcome|Rosuvastatin 10 mg|
314207|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314208|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314209|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314210|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314211|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314212|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314213|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314214|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314215|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314216|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314217|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314218|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314219|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314220|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314221|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314222|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314223|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314224|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314225|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314226|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314227|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314228|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314229|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314230|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314231|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314232|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314233|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314234|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314235|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314236|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314237|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314430|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314238|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314239|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314240|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314241|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314242|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314243|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314244|NCT00244725|E4|Reported Event|WARFARIN INR 2.0 TO 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
314245|NCT00244725|E3|Reported Event|ODIPARCIL MR 500 MG TABLET|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314246|NCT00244725|E2|Reported Event|ODIPARCIL MR 375 MG TABLET|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314247|NCT00244725|E1|Reported Event|ODIPARCIL MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
314248|NCT00244764|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
314249|NCT00244764|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
314250|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
314251|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
314252|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
314253|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
314254|NCT00244764|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
314255|NCT00244855|B3|Baseline|Total|Total of all reporting groups
314256|NCT00244855|B2|Baseline|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies"
314257|NCT00244855|B1|Baseline|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies"
314258|NCT00244855|P2|Participant Flow|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies"
314259|NCT00244855|P1|Participant Flow|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies"
314260|NCT00244855|O2|Outcome|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies"
314261|NCT00244855|O1|Outcome|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies"
314262|NCT00244855|O2|Outcome|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies"
314263|NCT00244855|O1|Outcome|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies"
314264|NCT00244855|E2|Reported Event|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies"
314265|NCT00244855|E1|Reported Event|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies"
314266|NCT00244881|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
314267|NCT00244881|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
314268|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
314269|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
314270|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
314271|NCT00244881|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
314272|NCT00244933|B1|Baseline|Gemcitabine, Genistein (Novasoy), Tumor Biopsy|"Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days
Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)"
314273|NCT00244933|P1|Participant Flow|Gemcitabine, Genistein (Novasoy), Tumor Biopsy|"Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days
Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)"
314274|NCT00244933|O1|Outcome|Gemcitabine & Genistein|Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
314275|NCT00244933|E1|Reported Event|Gemcitabine & Genistein|Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
315119|NCT00247962|P1|Participant Flow|Etanercept|etanercept 50 mg once weekly
314276|NCT00244985|B1|Baseline|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV"
314277|NCT00244985|P1|Participant Flow|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV"
314278|NCT00244985|O1|Outcome|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV"
314279|NCT00244985|O1|Outcome|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV"
314280|NCT00244985|O1|Outcome|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV"
314281|NCT00244985|O1|Outcome|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV"
314282|NCT00244985|O1|Outcome|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV"
314283|NCT00244985|E1|Reported Event|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV"
314284|NCT00245011|B1|Baseline|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell collection. Samarium Sm153 Lexidronam Pentasodium is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of Samarium-153 is given, followed in 14 days by stem cell infusion.
Filgrastim: Filgrastim will be administered every day til count recovery Ifosfamide: Ifosfamide will be administered as part of Stem Cell transplant prep.
Peripheral blood stem cell transplantation: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.
Samarium Sm 153 lexidronam pentasodium: First dose of Sm-EDTMP administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered 7 days later."
314285|NCT00245011|P1|Participant Flow|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium (Samarium)/Stem Cell Transplant/Radiation arm: receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by collection of stem cells. Samarium is administered after collection of peripheral blood stem cells (PBCT). Once counts recover, while receiving filgrastim daily, a second, higher dose of Samarium-153 is given, followed in 14 days by infusion of the stem cells.
Filgrastim: administered daily until count recovery Ifosfamide: administered as part of Stem Cell transplant preparation. PBCT: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.
Samarium: First dose is administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered after count recover. 14 days after administration of higher dose, patient undergoes autologous stem cell infusion."
314311|NCT00245063|B1|Baseline|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO"
314312|NCT00245063|P2|Participant Flow|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO"
314431|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314286|NCT00245011|O1|Outcome|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium (^153Sm-EDTMP)/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell harvest. ^153Sm-EDTMP is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of ^153Sm-EDTMP is given, followed in 14 days by stem cell infusion.
filgrastim: Filgrastim is administered every day til count recovery.
ifosfamide: Ifosfamide is administered as part of Stem Cell transplant prep.
peripheral blood stem cell harvesting: completed before administration of ^153Sm-EDTMP, collection of autologous hematopoietic stem cells.
radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of ^153Sm-EDTMP.
^153Sm-EDTMP: First dose is administered after autologous stem cell collection. Second, higher dose, is administered 1 week later."
314287|NCT00245011|E1|Reported Event|Samarium-153|"Cytoxan+Ifosfamide, Filgrastim pre samarium.'Sm-EDTMP (low dose). once counts recover, Sm-EDTMP (high dose) given. Peripheral blood stem cell transplantation is done 14 days later.
filgrastim: Filgrastim will be administered post post chemotherapy until target WBC count is achieved.
ifosfamide: Ifosfamide administered IV.
peripheral blood stem cell transplantation: Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered
Sm-EDTMP (low dose): Sm-EDTMP (low dose) administered after autologous stem cell collection
sm-EDTMP (higher dose): Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation."
314288|NCT00245037|B1|Baseline|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
314289|NCT00245037|P1|Participant Flow|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
314290|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
314291|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
314292|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
314313|NCT00245063|P1|Participant Flow|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO"
314314|NCT00245063|O2|Outcome|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO"
314432|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
328551|NCT00296374|O3|Outcome|Atorvastatin 80mg|
314293|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
314294|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
314328|NCT00245102|P3|Participant Flow|Leiomyosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
314329|NCT00245102|P2|Participant Flow|MPNST|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
314330|NCT00245102|P1|Participant Flow|Angiosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
314295|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
314296|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
314297|NCT00245037|E1|Reported Event|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
314298|NCT00245050|B3|Baseline|Total|Total of all reporting groups
314299|NCT00245050|B2|Baseline|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
314300|NCT00245050|B1|Baseline|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
314301|NCT00245050|P2|Participant Flow|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
314302|NCT00245050|P1|Participant Flow|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
314303|NCT00245050|O2|Outcome|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
314304|NCT00245050|O1|Outcome|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
314305|NCT00245050|O2|Outcome|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
314306|NCT00245050|O1|Outcome|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
314307|NCT00245050|E2|Reported Event|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
314308|NCT00245050|E1|Reported Event|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
314309|NCT00245063|B3|Baseline|Total|Total of all reporting groups
314310|NCT00245063|B2|Baseline|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO"
314315|NCT00245063|O1|Outcome|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO"
314316|NCT00245063|E2|Reported Event|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO"
314317|NCT00245063|E1|Reported Event|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO"
314318|NCT00245102|B7|Baseline|Total|Total of all reporting groups
314319|NCT00245102|B6|Baseline|Other Histology|Sorafenib 400 mg PO BID
314320|NCT00245102|B5|Baseline|Fibrosarcoma|Sorafenib 400 mg PO BID
314321|NCT00245102|B4|Baseline|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
314322|NCT00245102|B3|Baseline|Leiomyosarcoma|Sorafenib 400 mg PO BID
314323|NCT00245102|B2|Baseline|MPNST|Sorafenib 400 mg PO BID
314324|NCT00245102|B1|Baseline|Angiosarcoma|Sorafenib 400 mg PO BID
314325|NCT00245102|P6|Participant Flow|Other Histology|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
314326|NCT00245102|P5|Participant Flow|Fibrosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
314327|NCT00245102|P4|Participant Flow|Undifferentiated Pleomorphic Sarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
314343|NCT00245128|B1|Baseline|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
314344|NCT00245128|P1|Participant Flow|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
314345|NCT00245128|O1|Outcome|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
314346|NCT00245128|E1|Reported Event|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
314347|NCT00245219|B4|Baseline|Total|Total of all reporting groups
314348|NCT00245219|B3|Baseline|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
314349|NCT00245219|B2|Baseline|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
314350|NCT00245219|B1|Baseline|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
314351|NCT00245219|P3|Participant Flow|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
314352|NCT00245219|P2|Participant Flow|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
314353|NCT00245219|P1|Participant Flow|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
328552|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
314354|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
314355|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
314356|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
314357|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
314358|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
314359|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
314360|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
314466|NCT00245960|B2|Baseline|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
314361|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
314362|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
314363|NCT00245219|E3|Reported Event|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
314364|NCT00245219|E2|Reported Event|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
314365|NCT00245219|E1|Reported Event|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
314366|NCT00245466|B4|Baseline|Total|Total of all reporting groups
314367|NCT00245466|B3|Baseline|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314368|NCT00245466|B2|Baseline|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314369|NCT00245466|B1|Baseline|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314370|NCT00245466|P3|Participant Flow|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314371|NCT00245466|P2|Participant Flow|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314372|NCT00245466|P1|Participant Flow|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314373|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314374|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314375|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314376|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314377|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314378|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314379|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314380|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314381|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314382|NCT00245466|E3|Reported Event|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314383|NCT00245466|E2|Reported Event|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314384|NCT00245466|E1|Reported Event|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
314385|NCT00245557|B3|Baseline|Total|Total of all reporting groups
314386|NCT00245557|B2|Baseline|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
314387|NCT00245557|B1|Baseline|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
314388|NCT00245557|P2|Participant Flow|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
314389|NCT00245557|P1|Participant Flow|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
314390|NCT00245557|O3|Outcome|Post-treatment Depressed|
314391|NCT00245557|O2|Outcome|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
314392|NCT00245557|O1|Outcome|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
314393|NCT00245557|O2|Outcome|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
314394|NCT00245557|O1|Outcome|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
314395|NCT00245557|O2|Outcome|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
314396|NCT00245557|O1|Outcome|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
314397|NCT00245557|E2|Reported Event|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
314398|NCT00245557|E1|Reported Event|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
314399|NCT00245570|B1|Baseline|Overall Study Population|All randomized patients
314422|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314423|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
314424|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314425|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314426|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
314427|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314428|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314400|NCT00245570|P6|Participant Flow|Placebo/ Salmeterol/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
314401|NCT00245570|P5|Participant Flow|Placebo/ Montelukast/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo
inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
314402|NCT00245570|P4|Participant Flow|Salmeterol/ Placebo/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
314456|NCT00245635|E1|Reported Event|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.
Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
314457|NCT00245856|B1|Baseline|All DVT Treated Patients|Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
314458|NCT00245856|P2|Participant Flow|Dalteparin Only|200 units/kg for one month At month one, dosage reduction based on weight
314459|NCT00245856|P1|Participant Flow|Dalteparin + Warfarin|"200 units per kg with transition Warfarin titrated to INR 2-3
This arm was completed and new treatment regimen was substituted for the remainder of the study."
314403|NCT00245570|P3|Participant Flow|Salmeterol / Montelukast/ Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
314404|NCT00245570|P2|Participant Flow|Montelukast/ Placebo/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
314405|NCT00245570|P1|Participant Flow|Montelukast/ Salmeterol/Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
314406|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314407|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314408|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
314409|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314410|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314411|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
314412|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314413|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314414|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
314415|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314416|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314417|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
314418|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314419|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314420|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
314421|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314433|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314434|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314435|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
314436|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314437|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314438|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
314439|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
314440|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
314441|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
314442|NCT00245570|E6|Reported Event|Placebo/ Salmeterol/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
314460|NCT00245856|O1|Outcome|Dalteparin + Warfarin/Dalteparin Alone|Major bleeding rates
314461|NCT00245856|O1|Outcome|Dalteparin + Warfarin or Dalteparin Alone|Patients with arm DVT who received either 3 months of dalteparin + warfarin (INR 2-3) or Dalteparin alone
314462|NCT00245856|O1|Outcome|All DVT Treated Patients|Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
314463|NCT00245856|E2|Reported Event|Dalteparin Only|200 units/kg for one month At month one, dosage reduction based on weight
314464|NCT00245856|E1|Reported Event|Dalteparin + Warfarin|"200 units per kg with transition Warfarin titrated to INR 2-3
This arm was completed and new treatment regimen was substituted for the remainder of the study."
314443|NCT00245570|E5|Reported Event|Placebo/ Montelukast/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo
inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
314444|NCT00245570|E4|Reported Event|Salmeterol/ Placebo/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
314445|NCT00245570|E3|Reported Event|Salmeterol / Montelukast/ Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
314446|NCT00245570|E2|Reported Event|Montelukast/ Placebo/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
314447|NCT00245570|E1|Reported Event|Montelukast/ Salmeterol/Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.
Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.
During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.
Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.
During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
314448|NCT00245635|B3|Baseline|Total|Total of all reporting groups
314449|NCT00245635|B2|Baseline|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.
Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
314450|NCT00245635|B1|Baseline|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.
Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
328553|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
314451|NCT00245635|P2|Participant Flow|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.
Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
314452|NCT00245635|P1|Participant Flow|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.
Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
314453|NCT00245635|O2|Outcome|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.
Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
314454|NCT00245635|O1|Outcome|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.
Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
314455|NCT00245635|E2|Reported Event|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.
Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
314465|NCT00245960|B3|Baseline|Total|Total of all reporting groups
314600|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314467|NCT00245960|B1|Baseline|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
314468|NCT00245960|P2|Participant Flow|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
314469|NCT00245960|P1|Participant Flow|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
314470|NCT00245960|O2|Outcome|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
314471|NCT00245960|O1|Outcome|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
314472|NCT00245960|O2|Outcome|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
314473|NCT00245960|O1|Outcome|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
314474|NCT00245960|E2|Reported Event|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
314475|NCT00245960|E1|Reported Event|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
314476|NCT00246012|B10|Baseline|Total|Total of all reporting groups
314477|NCT00246012|B9|Baseline|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314478|NCT00246012|B8|Baseline|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314479|NCT00246012|B7|Baseline|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314480|NCT00246012|B6|Baseline|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314639|NCT00246025|E4|Reported Event|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314481|NCT00246012|B5|Baseline|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314482|NCT00246012|B4|Baseline|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314483|NCT00246012|B3|Baseline|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
314484|NCT00246012|B2|Baseline|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314485|NCT00246012|B1|Baseline|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314486|NCT00246012|P9|Participant Flow|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314487|NCT00246012|P8|Participant Flow|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
315120|NCT00247962|O2|Outcome|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
314488|NCT00246012|P7|Participant Flow|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314489|NCT00246012|P6|Participant Flow|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314490|NCT00246012|P5|Participant Flow|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314491|NCT00246012|P4|Participant Flow|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314492|NCT00246012|P3|Participant Flow|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
314493|NCT00246012|P2|Participant Flow|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314494|NCT00246012|P1|Participant Flow|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314554|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
314495|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314496|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314497|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314498|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314499|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
314500|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314501|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314601|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314602|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
315121|NCT00247962|O1|Outcome|Etanercept|etanercept 50 mg once weekly
314502|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314503|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314504|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314505|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314506|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314507|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314555|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314508|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314509|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314510|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314511|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314512|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314603|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
315122|NCT00247962|O2|Outcome|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
314513|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314514|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314515|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314516|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314517|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314518|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314519|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314520|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314521|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314690|NCT00246337|B10|Baseline|Total|Total of all reporting groups
314522|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314523|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314524|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314525|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314526|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314527|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314604|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314528|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314529|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314530|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314531|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314532|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314533|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314534|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314535|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314536|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314537|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314538|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314539|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314540|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314541|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314542|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314543|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314544|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314545|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314546|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314547|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314548|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314549|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314550|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314551|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314552|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314553|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314556|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314557|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
314558|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314559|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314560|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
314561|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314562|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314563|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
314564|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314565|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314566|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
314567|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314568|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314569|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
314570|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314635|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314636|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314571|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314572|NCT00246012|O5|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314573|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314574|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
314575|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314605|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314606|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
314576|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314577|NCT00246012|E9|Reported Event|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314578|NCT00246012|E8|Reported Event|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314579|NCT00246012|E7|Reported Event|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
314580|NCT00246012|E6|Reported Event|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
314581|NCT00246012|E5|Reported Event|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314582|NCT00246012|E4|Reported Event|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
314583|NCT00246012|E3|Reported Event|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
314584|NCT00246012|E2|Reported Event|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314637|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314638|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
314585|NCT00246012|E1|Reported Event|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
314586|NCT00246025|B5|Baseline|Total|Total of all reporting groups
314587|NCT00246025|B4|Baseline|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314588|NCT00246025|B3|Baseline|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314589|NCT00246025|B2|Baseline|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314590|NCT00246025|B1|Baseline|Treatment Group With Placebo|Patients were treated with matching Placebo.
314591|NCT00246025|P4|Participant Flow|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314592|NCT00246025|P3|Participant Flow|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314593|NCT00246025|P2|Participant Flow|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314594|NCT00246025|P1|Participant Flow|Treatment Group With Placebo|Patients were treated with matching Placebo.
314595|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314596|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314597|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314598|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
314599|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
315123|NCT00247962|O1|Outcome|Etanercept|etanercept 50 mg once weekly
314607|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314608|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314609|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314610|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
314611|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314612|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314613|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314614|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
314615|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314616|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314617|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314618|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
314619|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314620|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314621|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314622|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
314623|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314624|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314625|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314626|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
314627|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314628|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314629|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314630|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
314631|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
314632|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314633|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314634|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
328554|NCT00296374|O3|Outcome|Atorvastatin 80mg|
314640|NCT00246025|E3|Reported Event|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
314641|NCT00246025|E2|Reported Event|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
314642|NCT00246025|E1|Reported Event|Treatment Group With Placebo|Patients were treated with matching Placebo.
314643|NCT00246090|B1|Baseline|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
314644|NCT00246090|P1|Participant Flow|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
314645|NCT00246090|O1|Outcome|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
314646|NCT00246090|O1|Outcome|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
314647|NCT00246090|E1|Reported Event|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
314648|NCT00246259|B3|Baseline|Total|Total of all reporting groups
314649|NCT00246259|B2|Baseline|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314650|NCT00246259|B1|Baseline|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314651|NCT00246259|P2|Participant Flow|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314652|NCT00246259|P1|Participant Flow|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314653|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314654|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314655|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314656|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314657|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314658|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314659|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314660|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314661|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314662|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314663|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314664|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314665|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314666|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314722|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314667|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314668|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314669|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314670|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314671|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314672|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314673|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314674|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314675|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314676|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314677|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314678|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314679|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314680|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314681|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314682|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314683|NCT00246259|E2|Reported Event|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
314684|NCT00246259|E1|Reported Event|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
314685|NCT00246324|B1|Baseline|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
314686|NCT00246324|P1|Participant Flow|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
314687|NCT00246324|O1|Outcome|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
314688|NCT00246324|O1|Outcome|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
314689|NCT00246324|E1|Reported Event|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
314691|NCT00246337|B9|Baseline|Rizatriptan 10 mg|"Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study."
314692|NCT00246337|B8|Baseline|MK0974 600 mg|"MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study."
314693|NCT00246337|B7|Baseline|MK0974 400 mg|"MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study."
314694|NCT00246337|B6|Baseline|MK0974 300 mg|"MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study."
314695|NCT00246337|B5|Baseline|MK0974 200 mg|"MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study."
314696|NCT00246337|B4|Baseline|MK0974 100 mg|"MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study."
314697|NCT00246337|B3|Baseline|MK0974 50 mg|"MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study."
314698|NCT00246337|B2|Baseline|MK0974 25 mg|"MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study."
314699|NCT00246337|B1|Baseline|Placebo|"Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study."
314700|NCT00246337|P9|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314701|NCT00246337|P8|Participant Flow|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314702|NCT00246337|P7|Participant Flow|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314703|NCT00246337|P6|Participant Flow|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314704|NCT00246337|P5|Participant Flow|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314705|NCT00246337|P4|Participant Flow|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314706|NCT00246337|P3|Participant Flow|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314707|NCT00246337|P2|Participant Flow|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314708|NCT00246337|P1|Participant Flow|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
314709|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314710|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314711|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314712|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314713|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314714|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314715|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314716|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314717|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
314718|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314719|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314720|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314721|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
328555|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
314723|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314724|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314725|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314726|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
314727|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314728|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314729|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314730|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314731|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314732|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314733|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314734|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314735|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
314736|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314737|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314738|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314739|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314812|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314740|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314741|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314742|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314743|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314744|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
314745|NCT00246337|E9|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314746|NCT00246337|E8|Reported Event|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314747|NCT00246337|E7|Reported Event|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314748|NCT00246337|E6|Reported Event|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314749|NCT00246337|E5|Reported Event|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314750|NCT00246337|E4|Reported Event|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314751|NCT00246337|E3|Reported Event|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314752|NCT00246337|E2|Reported Event|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
314753|NCT00246337|E1|Reported Event|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
314754|NCT00239005|B3|Baseline|Total|Total of all reporting groups
314755|NCT00239005|B2|Baseline|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
314756|NCT00239005|B1|Baseline|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
314757|NCT00239005|P2|Participant Flow|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
314758|NCT00239005|P1|Participant Flow|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
328556|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
314759|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
314760|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
314761|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
314762|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
314763|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
314764|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
314765|NCT00239005|E2|Reported Event|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
314766|NCT00239005|E1|Reported Event|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
314767|NCT00239226|B5|Baseline|Total|Total of all reporting groups
314768|NCT00239226|B4|Baseline|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
314769|NCT00239226|B3|Baseline|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
314770|NCT00239226|B2|Baseline|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
314771|NCT00239226|B1|Baseline|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
314772|NCT00239226|P4|Participant Flow|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
314773|NCT00239226|P3|Participant Flow|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
314774|NCT00239226|P2|Participant Flow|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
314775|NCT00239226|P1|Participant Flow|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
315124|NCT00247962|E2|Reported Event|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
314776|NCT00239226|O4|Outcome|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
314777|NCT00239226|O3|Outcome|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
314778|NCT00239226|O2|Outcome|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
314779|NCT00239226|O1|Outcome|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
314780|NCT00239226|E4|Reported Event|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
314781|NCT00239226|E3|Reported Event|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
314782|NCT00239226|E2|Reported Event|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
314783|NCT00239226|E1|Reported Event|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
314784|NCT00239356|B3|Baseline|Total|Total of all reporting groups
314785|NCT00239356|B2|Baseline|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314786|NCT00239356|B1|Baseline|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314787|NCT00239356|P2|Participant Flow|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314788|NCT00239356|P1|Participant Flow|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314789|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314790|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314791|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314792|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314793|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314794|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314795|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314796|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314797|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314798|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314799|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314800|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314801|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314802|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314803|NCT00239356|E2|Reported Event|Schizophrenia 10 - 30 mg QD|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314804|NCT00239356|E1|Reported Event|Bipolar I Disorder 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
314805|NCT00239642|B4|Baseline|Total|Total of all reporting groups
314806|NCT00239642|B3|Baseline|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314807|NCT00239642|B2|Baseline|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314808|NCT00239642|B1|Baseline|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314809|NCT00239642|P3|Participant Flow|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314810|NCT00239642|P2|Participant Flow|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314811|NCT00239642|P1|Participant Flow|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314813|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314814|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314815|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314816|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314817|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314818|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314819|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314820|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314821|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314822|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314823|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314824|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314825|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314826|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314827|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314828|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314829|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314830|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314831|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314832|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314833|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314834|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314835|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314836|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314837|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314838|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314839|NCT00239642|E3|Reported Event|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314840|NCT00239642|E2|Reported Event|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314841|NCT00239642|E1|Reported Event|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
314842|NCT00239681|B3|Baseline|Total|Total of all reporting groups
314843|NCT00239681|B2|Baseline|Placebo|Placebo once daily
314844|NCT00239681|B1|Baseline|Rosuvastatin|Rosuvastatin 20 mg once daily
314845|NCT00239681|P2|Participant Flow|Placebo|Placebo once daily
314846|NCT00239681|P1|Participant Flow|Rosuvastatin|Rosuvastatin 20 mg once daily
314847|NCT00239681|O2|Outcome|Placebo|Placebo once daily
314848|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
314849|NCT00239681|O2|Outcome|Placebo|Placebo once daily
314850|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
314851|NCT00239681|O2|Outcome|Placebo|Placebo once daily
314852|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
314853|NCT00239681|O2|Outcome|Placebo|Placebo once daily
314854|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
314855|NCT00239681|O2|Outcome|Placebo|Placebo once daily
314856|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
314857|NCT00239681|O2|Outcome|Placebo|Placebo once daily
314858|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
314859|NCT00239681|E2|Reported Event|ROSUVASTATIN 20 MG|
314860|NCT00239681|E1|Reported Event|PLACEBO|
314861|NCT00239720|B3|Baseline|Total|Total of all reporting groups
314862|NCT00239720|B2|Baseline|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
314863|NCT00239720|B1|Baseline|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
314864|NCT00239720|P2|Participant Flow|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
314865|NCT00239720|P1|Participant Flow|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
314866|NCT00239720|O2|Outcome|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
314867|NCT00239720|O1|Outcome|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
314868|NCT00239720|E2|Reported Event|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
314869|NCT00239720|E1|Reported Event|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
314870|NCT00239733|B1|Baseline|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.
Anti-D: 30-minute infusion administered in an outpatient setting"
314871|NCT00239733|P1|Participant Flow|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.
Anti-D: 30-minute infusion administered in an outpatient setting"
314872|NCT00239733|O1|Outcome|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.
Anti-D: 30-minute infusion administered in an outpatient setting"
314873|NCT00239733|O1|Outcome|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.
Anti-D: 30-minute infusion administered in an outpatient setting"
314874|NCT00239733|E1|Reported Event|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.
Anti-D: 30-minute infusion administered in an outpatient setting"
314875|NCT00239837|B3|Baseline|Total|Total of all reporting groups
314876|NCT00239837|B2|Baseline|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
314877|NCT00239837|B1|Baseline|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
314919|NCT00240097|E3|Reported Event|Regimen A Overall Toxicity|Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
314954|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
314878|NCT00239837|P2|Participant Flow|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
314879|NCT00239837|P1|Participant Flow|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
314880|NCT00239837|O2|Outcome|Foster Care Services as Usual|Foster Care Services as Usual: Participants continue with usual foster care
314881|NCT00239837|O1|Outcome|Middle School Success Intervention (MSS)|"Middle School Success Intervention (MSS): Participants receive the preventative intervention
Middle School Success Intervention (MSS): This is a 10-month, psychosocial intervention for foster parents and girls, with administration of the intervention beginning the summer before entry into middle school. The intervention consists of: (1) six summer Pride groups for the girls, (2) six summer parenting intervention sessions for the foster parents; (3) weekly foster parent training and support sessions for foster parents during the first year of middle school; and (4) weekly individual skills training for the girls during the first year of middle school."
314930|NCT00240110|O1|Outcome|Lithium Carbonate Add on Placebo|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo
314931|NCT00240110|E2|Reported Event|Lithium Carbonate Add on Valproate|Lithium carbonate as standard treatment add on double blind valproate
314932|NCT00240110|E1|Reported Event|Lithium Carbonate Add on Placebo|Lithium carbonate as standard treatment add on double blind placebo
314980|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
315125|NCT00247962|E1|Reported Event|Etanercept|etanercept 50 mg once weekly
314882|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
314883|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
314884|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
314885|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
314886|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
314953|NCT00240331|O2|Outcome|Placebo|Matching placebo
314887|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
314888|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
314933|NCT00240162|B1|Baseline|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
314981|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
314982|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
315126|NCT00248170|B3|Baseline|Total|Total of all reporting groups
314889|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
314890|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
314891|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
314892|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
314893|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
314894|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
314895|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
314896|NCT00239837|E2|Reported Event|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
314897|NCT00239837|E1|Reported Event|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
314898|NCT00239928|B1|Baseline|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
314899|NCT00239928|P1|Participant Flow|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
314900|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
314901|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
314902|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
314903|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
314904|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
314905|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
314906|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
314907|NCT00239928|E1|Reported Event|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
314908|NCT00240071|B1|Baseline|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
314909|NCT00240071|P1|Participant Flow|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
314910|NCT00240071|O1|Outcome|Avastin (Bevacizumab) Plus Hormone|All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.
314911|NCT00240071|E1|Reported Event|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
314912|NCT00240097|B1|Baseline|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks.
314913|NCT00240097|P1|Participant Flow|Regimen A and B|"Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)"
314914|NCT00240097|O1|Outcome|Part II - After Relapse|Study dosing with A and B based on relapse
314915|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
314916|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
314917|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
314918|NCT00240097|E4|Reported Event|Regimen B Overall Toxicity|Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
314920|NCT00240097|E2|Reported Event|Regimen B First Cycle|Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
314921|NCT00240097|E1|Reported Event|Regimen A First Cycle|Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
314922|NCT00240110|B3|Baseline|Total|Total of all reporting groups
314923|NCT00240110|B2|Baseline|Lithium Carbonate Add on Valproate|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
314924|NCT00240110|B1|Baseline|Lithium Carbonate Add on Placebo|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo
314925|NCT00240110|P2|Participant Flow|Lithium Carbonate Add on Valproate|Lithium carbonate started and participants randomized to valproate
314926|NCT00240110|P1|Participant Flow|Lithium Carbonate Add on Placebo|Lithium started and then participants randomized to placebo
314927|NCT00240110|O2|Outcome|Lithium Carbonate Add on Valproate|Open label lithium carbonate as standard treatment and double blinded valproate
314928|NCT00240110|O1|Outcome|Lithium Carbonate Add on Placebo|Open label lithium carbonate as standard treatment and double blinded placebo
314929|NCT00240110|O2|Outcome|Lithium Carbonate Add on Valproate|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
315127|NCT00248170|B2|Baseline|Anastrozole|1 mg p.o. once daily
314934|NCT00240162|P1|Participant Flow|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
314935|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
314936|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
314937|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
314938|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
314939|NCT00240162|E1|Reported Event|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
314940|NCT00240227|B1|Baseline|All Study Paricipants|"Placebo no active medication
placebo
Prazosin
FDA approved medication for hypertension"
314941|NCT00240227|P1|Participant Flow|All Study Participants|"Placebo no active medication
placebo
Prazosin flexible dose titration up to 12 mg per day.
Prazosin: FDA approved medication for hypertension"
314942|NCT00240227|O2|Outcome|Prazosin|"Prazosin flexible dose titration up to 12 mg per day.
Prazosin: FDA approved medication for hypertension"
314943|NCT00240227|O1|Outcome|Placebo|"Placebo no active medication
placebo"
314944|NCT00240227|E2|Reported Event|Prazosin|"Prazosin flexible dose titration up to 12 mg per day.
Prazosin: FDA approved medication for hypertension"
314945|NCT00240227|E1|Reported Event|Placebo|"Placebo no active medication
placebo"
314946|NCT00240331|B3|Baseline|Total|Total of all reporting groups
314947|NCT00240331|B2|Baseline|Placebo|Matching placebo
314948|NCT00240331|B1|Baseline|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
314949|NCT00240331|P2|Participant Flow|Placebo|Matching placebo
314950|NCT00240331|P1|Participant Flow|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
314951|NCT00240331|O2|Outcome|Placebo|Matching placebo
314952|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
314956|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
314957|NCT00240331|O2|Outcome|Placebo|Matching placebo
314958|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
314959|NCT00240331|O2|Outcome|Placebo|Matching placebo
314960|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
314961|NCT00240331|O2|Outcome|Placebo|Matching placebo
314962|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
314963|NCT00240331|O2|Outcome|Placebo|Matching placebo
314964|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
314965|NCT00240331|E2|Reported Event|Placebo|Matching placebo
314966|NCT00240331|E1|Reported Event|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
314967|NCT00246376|B6|Baseline|Total|Total of all reporting groups
314968|NCT00246376|B5|Baseline|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
314969|NCT00246376|B4|Baseline|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
314970|NCT00246376|B3|Baseline|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
314971|NCT00246376|B2|Baseline|Group 2: Diet / Exercise|Diet, exercise, and two placebos
314972|NCT00246376|B1|Baseline|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
314973|NCT00246376|P5|Participant Flow|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
314974|NCT00246376|P4|Participant Flow|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
314975|NCT00246376|P3|Participant Flow|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
314976|NCT00246376|P2|Participant Flow|Group 2: Diet / Exercise|Diet, exercise, and two placebos
314977|NCT00246376|P1|Participant Flow|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
314978|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
314979|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
315081|NCT00247611|O4|Outcome|Intervention (On Protocol)|152 (55%) of the ITT included intervention arm participants
314983|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
314984|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
314985|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
314986|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
314987|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
314988|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
314989|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
314990|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
314991|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
314992|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
314993|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
314994|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
314995|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
314996|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
314997|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
314998|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|
314999|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|
315000|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|
315001|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise|
315002|NCT00246376|O1|Outcome|Group 1 - Usual Care|
315003|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|
315004|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|
315005|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|
315006|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|
315007|NCT00246376|O1|Outcome|Group 1 - Usual Care|
315008|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
315009|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
315010|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
315011|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
315159|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
315012|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
315013|NCT00246376|E5|Reported Event|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
315014|NCT00246376|E4|Reported Event|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
315015|NCT00246376|E3|Reported Event|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
315016|NCT00246376|E2|Reported Event|Group 2: Diet / Exercise|Diet, exercise, and two placebos
315017|NCT00246376|E1|Reported Event|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
315018|NCT00246519|B3|Baseline|Total|Total of all reporting groups
315019|NCT00246519|B2|Baseline|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
315020|NCT00246519|B1|Baseline|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
315021|NCT00246519|P2|Participant Flow|Hydrochlorothiazide (HCTZ) + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
315022|NCT00246519|P1|Participant Flow|Atenolol + Hydroclorothiazide (HCTZ) Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
315023|NCT00246519|O2|Outcome|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
315024|NCT00246519|O1|Outcome|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
315025|NCT00246519|E2|Reported Event|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
315026|NCT00246519|E1|Reported Event|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
315027|NCT00246571|B3|Baseline|Total|Total of all reporting groups
315028|NCT00246571|B2|Baseline|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315029|NCT00246571|B1|Baseline|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315030|NCT00246571|P2|Participant Flow|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315031|NCT00246571|P1|Participant Flow|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315032|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315033|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315034|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315035|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315051|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315160|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
328557|NCT00296374|O3|Outcome|Atorvastatin 80mg|
315036|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315037|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315038|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315039|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315040|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315041|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315042|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315043|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315044|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315045|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315046|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315047|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315048|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315049|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315050|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315101|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315052|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315053|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315054|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315055|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315056|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315057|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315058|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315059|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315060|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315061|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315062|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315063|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315064|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315102|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
328558|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
315065|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315066|NCT00246571|E2|Reported Event|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
315067|NCT00246571|E1|Reported Event|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
315068|NCT00247611|B3|Baseline|Total|Total of all reporting groups
315069|NCT00247611|B2|Baseline|Intervention|Participants will receive the LifeWindows Intervention sessions
315070|NCT00247611|B1|Baseline|Control|Participants will receive the control condition
315071|NCT00247611|P2|Participant Flow|Intervention|Participants will receive the LifeWindows Intervention sessions
315072|NCT00247611|P1|Participant Flow|Control|Participants will receive the control condition
315073|NCT00247611|O2|Outcome|Total Excluded From OP Sample|ITT sample excluded from the post-hoc analysis of the participants provided >=6 assessments with no ART receipt interruptions (ITT - OP sample)
315074|NCT00247611|O1|Outcome|On Protocol (OP) Sample|Post-hoc analysis of the participants provided >=6 assessments with no ART receipt interruptions
315075|NCT00247611|O4|Outcome|Intervention (On Protocol Sample)|152 (55%) of the ITT included intervention arm participants
315076|NCT00247611|O3|Outcome|Control (On Protocol Sample)|176 (61%) of the ITT included control arm participants
315077|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
315078|NCT00247611|O1|Outcome|Control (ITT Sample)|287 (94%) of the 304 randomized to control
315079|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
315080|NCT00247611|O1|Outcome|Control (ITT Sample)|287 (94%) of the 304 randomized to control
315082|NCT00247611|O3|Outcome|Control (On Protocol Sample)|176 (61%) of the ITT included control arm participants
315083|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
315084|NCT00247611|O1|Outcome|Control (ITT Sample %)|287 (94%) of the 304 randomized to control
315085|NCT00247611|E2|Reported Event|Intervention|Participants will receive the LifeWindows Intervention sessions
315086|NCT00247611|E1|Reported Event|Control|Participants will receive the control condition
315087|NCT00247676|B1|Baseline|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315088|NCT00247676|P1|Participant Flow|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315089|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315090|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315091|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315092|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315093|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315094|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315095|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315096|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315097|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315098|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315099|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315100|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315103|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315104|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315105|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315106|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315107|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315108|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315109|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315110|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315111|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315112|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315113|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315114|NCT00247676|E1|Reported Event|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
315115|NCT00247962|B3|Baseline|Total|Total of all reporting groups
315116|NCT00247962|B2|Baseline|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
315117|NCT00247962|B1|Baseline|Etanercept|etanercept 50 mg once weekly
315118|NCT00247962|P2|Participant Flow|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
315130|NCT00248170|P1|Participant Flow|Letrozole|2.5 mg by mouth (p.o.) once daily
315131|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
315132|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
315133|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
315134|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
315135|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
315136|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
315137|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
315138|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
315139|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
315140|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
315141|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
315142|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
315143|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
315144|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
315145|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
315146|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
315147|NCT00248170|E2|Reported Event|Anastrozole|Anastrozole
315148|NCT00248170|E1|Reported Event|Letrozole|Letrozole
315149|NCT00248287|B3|Baseline|Total|Total of all reporting groups
315150|NCT00248287|B2|Baseline|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
315151|NCT00248287|B1|Baseline|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
315152|NCT00248287|P2|Participant Flow|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
315153|NCT00248287|P1|Participant Flow|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
315154|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
315155|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
315156|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
315157|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
315158|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
328559|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
315161|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
315162|NCT00248287|E2|Reported Event|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
315163|NCT00248287|E1|Reported Event|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
315164|NCT00248495|B1|Baseline|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses
cisplatin: Given IV
pemetrexed disodium: Given IV
adjuvant therapy: Metastasis prevention/control
conventional surgery: Undergoing tissue removal
neoadjuvant therapy: Tumor Reduction"
315165|NCT00248495|P1|Participant Flow|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses
cisplatin: Given IV
pemetrexed disodium: Given IV
adjuvant therapy: Metastasis prevention/control
conventional surgery: Undergoing tissue removal
neoadjuvant therapy: Tumor Reduction"
315166|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses
cisplatin: Given IV
pemetrexed disodium: Given IV
adjuvant therapy: Metastasis prevention/control
conventional surgery: Undergoing tissue removal
neoadjuvant therapy: Tumor Reduction"
315167|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses
cisplatin: Given IV
pemetrexed disodium: Given IV
adjuvant therapy: Metastasis prevention/control
conventional surgery: Undergoing tissue removal
neoadjuvant therapy: Tumor Reduction"
315168|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses
cisplatin: Given IV
pemetrexed disodium: Given IV
adjuvant therapy: Metastasis prevention/control
conventional surgery: Undergoing tissue removal
neoadjuvant therapy: Tumor Reduction"
315169|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses
cisplatin: Given IV
pemetrexed disodium: Given IV
adjuvant therapy: Metastasis prevention/control
conventional surgery: Undergoing tissue removal
neoadjuvant therapy: Tumor Reduction"
315170|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses
cisplatin: Given IV
pemetrexed disodium: Given IV
adjuvant therapy: Metastasis prevention/control
conventional surgery: Undergoing tissue removal
neoadjuvant therapy: Tumor Reduction"
315171|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses
cisplatin: Given IV
pemetrexed disodium: Given IV
adjuvant therapy: Metastasis prevention/control
conventional surgery: Undergoing tissue removal
neoadjuvant therapy: Tumor Reduction"
315172|NCT00248495|E1|Reported Event|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses
cisplatin: Given IV
pemetrexed disodium: Given IV
adjuvant therapy: Metastasis prevention/control
conventional surgery: Undergoing tissue removal
neoadjuvant therapy: Tumor Reduction"
315173|NCT00248547|B3|Baseline|Total|Total of all reporting groups
315174|NCT00248547|B2|Baseline|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
315175|NCT00248547|B1|Baseline|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
315176|NCT00248547|P2|Participant Flow|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
315177|NCT00248547|P1|Participant Flow|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
315178|NCT00248547|O2|Outcome|Placebo (Sugar Pill)|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
315179|NCT00248547|O1|Outcome|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
315180|NCT00248547|E2|Reported Event|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
315181|NCT00248547|E1|Reported Event|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
315182|NCT00248560|B1|Baseline|Gemcitabine, Docetaxel|"docetaxel
gemcitabine hydrochloride"
315183|NCT00248560|P1|Participant Flow|Gemcitabine, Docetaxel|"docetaxel
gemcitabine hydrochloride"
315184|NCT00248560|O1|Outcome|Gemcitabine Hydrochloride, Docetaxel|Gemcitabine hydrochloride given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine hydrochloride.
315185|NCT00248560|E1|Reported Event|Gemcitabine, Docetaxel|"docetaxel
gemcitabine hydrochloride"
315186|NCT00248612|B5|Baseline|Total|Total of all reporting groups
315187|NCT00248612|B4|Baseline|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315188|NCT00248612|B3|Baseline|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
315189|NCT00248612|B2|Baseline|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315190|NCT00248612|B1|Baseline|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
315191|NCT00248612|P4|Participant Flow|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315192|NCT00248612|P3|Participant Flow|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
315193|NCT00248612|P2|Participant Flow|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315194|NCT00248612|P1|Participant Flow|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper. They will also receive tailored cognitive behavioral training (CBT)
315195|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315196|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
315197|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315198|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
315199|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315200|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
315201|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315202|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
315203|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315204|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
315205|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315206|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
315207|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315208|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
315209|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315409|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315210|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
315211|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315212|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
315213|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315214|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
315215|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315216|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
315217|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315218|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
315219|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315220|NCT00248612|O3|Outcome|Venlafaxine & PMR|Placebo medication and PMR (progressive muscle relaxation therapy).
315221|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315294|NCT00248781|P2|Participant Flow|Attention Control Group|attention control (health education)
315295|NCT00248781|P1|Participant Flow|Automated Exercise Group|Telecommunications system for exercise
315222|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
315223|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315224|NCT00248612|O3|Outcome|Venlafaxine & PMR|Placebo medication and PMR (progressive muscle relaxation therapy).
315225|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315226|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
315227|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315228|NCT00248612|O3|Outcome|Venlafaxine & PMR|Placebo medication and PMR (progressive muscle relaxation therapy).
315229|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315230|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
315231|NCT00248612|E4|Reported Event|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
315232|NCT00248612|E3|Reported Event|Venlafaxine & PMR|Venlafaxine medication and PMR (progressive muscle relaxation therapy).
315233|NCT00248612|E2|Reported Event|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
315234|NCT00248612|E1|Reported Event|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
315235|NCT00248625|B3|Baseline|Total|Total of all reporting groups
315236|NCT00248625|B2|Baseline|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
315237|NCT00248625|B1|Baseline|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
315276|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
315354|NCT00248807|O2|Outcome|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug
315238|NCT00248625|P2|Participant Flow|N-acetylcysteine (NAC)|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization.
N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge."
315239|NCT00248625|P1|Participant Flow|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to placebo consisting of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, liver transplantation, or death within 7 days of randomization.
Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications."
315240|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
315241|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
315242|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
315243|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
315296|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
315244|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
315245|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
315246|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
315247|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
315248|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
315249|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
315250|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
315251|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
315252|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
315253|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
315254|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
315255|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
315256|NCT00248625|E2|Reported Event|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization."
315257|NCT00248625|E1|Reported Event|N-acetylcysteine (NAC)|"Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days
N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge."
315258|NCT00248638|B3|Baseline|Total|Total of all reporting groups
315259|NCT00248638|B2|Baseline|Standard|Participants given standard nutrition without glutamine dipeptide
315260|NCT00248638|B1|Baseline|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
315261|NCT00248638|P2|Participant Flow|Standard|Participants given standard nutrition without glutamine dipeptide
315262|NCT00248638|P1|Participant Flow|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
315290|NCT00248651|E1|Reported Event|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
315291|NCT00248781|B3|Baseline|Total|Total of all reporting groups
315292|NCT00248781|B2|Baseline|Arm 2|attention control (health education)
315293|NCT00248781|B1|Baseline|Arm 1|Telecommunications system for exercise
315263|NCT00248638|O2|Outcome|Standard|"Participants given standard nutrition without glutamine dipeptide
Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.
Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
315264|NCT00248638|O1|Outcome|Glutamine Dipeptide|"Glutamine dipeptide supplemented nutrition to be given to participants.
Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.
Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
315265|NCT00248638|O2|Outcome|Standard|Participants given standard nutrition without glutamine dipeptide
315266|NCT00248638|O1|Outcome|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
315267|NCT00248638|E2|Reported Event|Standard|Participants given standard nutrition without glutamine dipeptide
315268|NCT00248638|E1|Reported Event|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
315269|NCT00248651|B4|Baseline|Total|Total of all reporting groups
315270|NCT00248651|B3|Baseline|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
315271|NCT00248651|B2|Baseline|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
315272|NCT00248651|B1|Baseline|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
315273|NCT00248651|P3|Participant Flow|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
315274|NCT00248651|P2|Participant Flow|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
315275|NCT00248651|P1|Participant Flow|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
315277|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
315278|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
315279|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
315280|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
315281|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
315282|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
315283|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
315284|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
315285|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
315286|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
315287|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
315288|NCT00248651|E3|Reported Event|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
315289|NCT00248651|E2|Reported Event|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
315297|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
315298|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
315299|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
315300|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
315301|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
315302|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
315303|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
315304|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
315305|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
315306|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
315307|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
315308|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
315309|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
315310|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
315311|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
315312|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
315313|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
315314|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
315315|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
315316|NCT00248781|E2|Reported Event|Attention Control Group|attention control (health education)
315317|NCT00248781|E1|Reported Event|Automated Exercise Group|Telecommunications system for exercise
315318|NCT00248794|B4|Baseline|Total|Total of all reporting groups
315319|NCT00248794|B3|Baseline|Skills Group Only|Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks
315320|NCT00248794|B2|Baseline|ICBCR + Skills Group|Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks
315321|NCT00248794|B1|Baseline|CRT +Skills Group|Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks
315322|NCT00248794|P3|Participant Flow|Skills Group Control|Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
315323|NCT00248794|P2|Participant Flow|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation
Participants received up to 5 hours of ICBRC and weekly skills group"
315324|NCT00248794|P1|Participant Flow|CRT + Skills Training|"Cognitive Remediation therapy+ skills training
Participants received up to 5 hours of CRT and weekly skills training group"
315325|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
315326|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.
Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
315407|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315327|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.
Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
315328|NCT00248794|O3|Outcome|Skills Group Control|Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks
315329|NCT00248794|O2|Outcome|ICBCR and Skills Training|Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks
315330|NCT00248794|O1|Outcome|CRT + Skills Training|Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks
315331|NCT00248794|O3|Outcome|Skills Group Control|Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
315332|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation
Participants received up to 5 hours of ICBRC and weekly skills group"
315333|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy+ skills training
Participants received up to 5 hours of CRT and weekly skills training group"
315334|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
315335|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.
Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
315336|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.
Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
315337|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
315338|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.
Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
315339|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.
Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
315340|NCT00248794|E3|Reported Event|Skills Group + Generic Contact|Life skills group + up to five individual contacts with research staff without active cognitive training
315341|NCT00248794|E2|Reported Event|ICBCR + Skills Group|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.
Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
315342|NCT00248794|E1|Reported Event|CRT+Skills Group|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.
Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
315343|NCT00248807|B3|Baseline|Total|Total of all reporting groups
315344|NCT00248807|B2|Baseline|Non-spinal Cord Injured Subjects|Non-spinal cord injured subjects underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
315345|NCT00248807|B1|Baseline|Subjects With Spinal Cord Injury|Subjects with spinal cord injury underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
315346|NCT00248807|P2|Participant Flow|Subjects Without SCI (Non-SCI)|Subjects without SCI (non-SCI) underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
315347|NCT00248807|P1|Participant Flow|Subjects With Spinal Cord Injury (SCI)|Subjects with SCI underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
315348|NCT00248807|O4|Outcome|ARM 4|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
315349|NCT00248807|O3|Outcome|ARM 3|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
315350|NCT00248807|O2|Outcome|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug.
315351|NCT00248807|O1|Outcome|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug.
315352|NCT00248807|O4|Outcome|ARM 4|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
315353|NCT00248807|O3|Outcome|ARM 3|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
315408|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315355|NCT00248807|O1|Outcome|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug
315356|NCT00248807|E4|Reported Event|ARM 4|1.25 mg enalaprilat IV and 45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied controls.
315357|NCT00248807|E3|Reported Event|ARM 3|1.25 mg enalaprilat IV and 45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury.
315358|NCT00248807|E2|Reported Event|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied controls.
315359|NCT00248807|E1|Reported Event|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury.
315360|NCT00249002|B1|Baseline|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315361|NCT00249002|P1|Participant Flow|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315362|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315363|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315364|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315365|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315366|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315367|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315368|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315369|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315370|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315470|NCT00249496|B3|Baseline|Total|Total of all reporting groups
315371|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315372|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315373|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315374|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315375|NCT00249002|E1|Reported Event|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
315376|NCT00249249|B5|Baseline|Total|Total of all reporting groups
315377|NCT00249249|B4|Baseline|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315378|NCT00249249|B3|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315379|NCT00249249|B2|Baseline|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315380|NCT00249249|B1|Baseline|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315381|NCT00249249|P4|Participant Flow|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315382|NCT00249249|P3|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315383|NCT00249249|P2|Participant Flow|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315384|NCT00249249|P1|Participant Flow|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315385|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315386|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315387|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315388|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315389|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315390|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315391|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315392|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315393|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315394|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315395|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315396|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315397|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315398|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315399|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315400|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315401|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315402|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315403|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315404|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315405|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315406|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315411|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315412|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315413|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315414|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315415|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315416|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315417|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315418|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315419|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315420|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315421|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315422|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315423|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315424|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315425|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315426|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315427|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315428|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315429|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315430|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315431|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315432|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315433|NCT00249249|E4|Reported Event|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
315434|NCT00249249|E3|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
315435|NCT00249249|E2|Reported Event|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
315436|NCT00249249|E1|Reported Event|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
315437|NCT00249288|B3|Baseline|Total|Total of all reporting groups
315438|NCT00249288|B2|Baseline|Folate|Patients underwent a 12 week trial of folate 2 mg/d
315439|NCT00249288|B1|Baseline|Placebo|Participants received 2 mg/daily of placebo, for 12 weeks
315440|NCT00249288|P2|Participant Flow|Placebo|
315441|NCT00249288|P1|Participant Flow|Folate|Participants receiving 2 mg/daily of folate, for 12 weeks
315442|NCT00249288|O2|Outcome|Placebo|"Participants will receive a 2 mg/ day dose of placebo, for 12 weeks
Placebo: Placebo taken by mouth daily as 2, 1mg capsule daily for 12 weeks"
315443|NCT00249288|O1|Outcome|Folate|"Participants will receive a 2 mg/ day dose of folate, for 12 weeks
Folate: Folic acid taken as 2, 1mg capsule daily for 12 weeks"
315444|NCT00249288|E2|Reported Event|Placebo|Participants receiving 2mg/daily of placebo, for 12 weeks
315445|NCT00249288|E1|Reported Event|Folate|Participants receiving 2 mg/daily of folate, for 12 weeks
315446|NCT00249379|B3|Baseline|Total|Total of all reporting groups
315447|NCT00249379|B2|Baseline|Control|No specific intervention, monitored for outcomes
315448|NCT00249379|B1|Baseline|Acamprosate|Criminal justice supervisees given acamprosate for alcohol dependence
315449|NCT00249379|P2|Participant Flow|Control|No specific intervention, received standard Drug Court counseling, monitored for outcomes
315450|NCT00249379|P1|Participant Flow|Acamprosate|Criminal justice supervisees given acamprosate 333 mg, 2 tablets orally 3 times daily for alcohol dependence for a 12-week period
315451|NCT00249379|O2|Outcome|Control|
315452|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
315453|NCT00249379|O2|Outcome|Control|
315454|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
315455|NCT00249379|O2|Outcome|Control|
315456|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
315457|NCT00249379|O2|Outcome|Control|
315458|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
315459|NCT00249379|E2|Reported Event|Control|No specific intervention, monitored for outcomes
315460|NCT00249379|E1|Reported Event|Acamprosate|Criminal justice supervisees given acamprosate for alcohol dependence
315461|NCT00249470|B3|Baseline|Total|Total of all reporting groups
315462|NCT00249470|B2|Baseline|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
315463|NCT00249470|B1|Baseline|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
315464|NCT00249470|P2|Participant Flow|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
315564|NCT00243386|P3|Participant Flow|Standard Prophylaxis|The standard prophylactic regimen was dosed at 20 to 40 IU/kg of rAHF-PFM every 48 ±6 hours
315878|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315465|NCT00249470|P1|Participant Flow|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
315466|NCT00249470|O2|Outcome|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
315467|NCT00249470|O1|Outcome|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
315468|NCT00249470|E2|Reported Event|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
315469|NCT00249470|E1|Reported Event|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
315471|NCT00249496|B2|Baseline|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
315472|NCT00249496|B1|Baseline|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
315473|NCT00249496|P2|Participant Flow|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
315474|NCT00249496|P1|Participant Flow|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
315475|NCT00249496|O2|Outcome|Contingency Management|Participants in the Contingency Management group were employed for one year in a Therapeutic Workplace business and had to provide drug-free urine samples to work and earn salary.
315476|NCT00249496|O1|Outcome|Employment Only|Employment Only participants were offered employment for one year, but these participants did not have to provide drug-free urine samples to work.
315477|NCT00249496|O2|Outcome|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
315478|NCT00249496|O1|Outcome|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
315479|NCT00249496|O2|Outcome|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
315480|NCT00249496|O1|Outcome|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
315481|NCT00249496|O2|Outcome|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
315482|NCT00249496|O1|Outcome|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
315483|NCT00249496|O2|Outcome|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
315484|NCT00249496|O1|Outcome|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
315485|NCT00249496|E2|Reported Event|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
315486|NCT00249496|E1|Reported Event|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
315487|NCT00249613|B3|Baseline|Total|Total of all reporting groups
315488|NCT00249613|B2|Baseline|Mixed-Gender Treatment 139 Subjects|Out-patient substance abuse treatment for women and men
315489|NCT00249613|B1|Baseline|Women-Only Treatment 152 Subjects|Out-patient gender-responsive substance abuse treatment for women only
315490|NCT00249613|P2|Participant Flow|Mixed-Gender Treatment 139 Subjects|Out-patient substance abuse treatment that included both women and men
315491|NCT00249613|P1|Participant Flow|Women-Only Treatment 152 Subjects|Out patient gender-responsive substance abuse treatment for women only
315492|NCT00249613|O1|Outcome|Group Status (Women-Only Compared to Mixed-Gender|Comparison of outcome in Women-Only vs. Mixed-Gender treatment
315493|NCT00249613|O1|Outcome|Group Status (Women-Only Compared to Mixed-Gender)|Outpatient gender-responsive substance abuse treatment for women only vs. outpatient mixed-gender substance abuse treatment
315494|NCT00249613|O1|Outcome|Women-Only Compared to Mixed-Gender|Outpatient gender-responsive substance abuse treatment for women only compared to outpatient substance abuse treatment for women and men
315495|NCT00249613|O2|Outcome|Mixed-Gender|Substance abuse treatment program for both women and men
315496|NCT00249613|O1|Outcome|Women-Only|"Substance abuse treatment program for women only
Women-Only: Gender-responsive treatment for women only"
315497|NCT00249613|E2|Reported Event|Mixed-Gender|Outpatient mixed-gender substance abuse treatment
315498|NCT00249613|E1|Reported Event|Women-Only|Outpatient gender-responsive substance abuse treatment for women only
315499|NCT00249795|B3|Baseline|Total|Total of all reporting groups
315500|NCT00249795|B2|Baseline|Placebo|matching placebo up to final follow-up visit
315501|NCT00249795|B1|Baseline|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
315502|NCT00249795|P2|Participant Flow|Placebo|matching placebo up to final follow-up visit
315503|NCT00249795|P1|Participant Flow|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
315504|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
315505|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
315506|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
315507|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
315508|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
315509|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
315510|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
315511|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
315512|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
315513|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
315514|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
315515|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
315516|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
315517|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
315518|NCT00249795|E2|Reported Event|Placebo|matching placebo up to final follow-up visit
315519|NCT00249795|E1|Reported Event|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
315520|NCT00249821|B3|Baseline|Total|Total of all reporting groups
315521|NCT00249821|B2|Baseline|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
315522|NCT00249821|B1|Baseline|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
315523|NCT00249821|P2|Participant Flow|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
315524|NCT00249821|P1|Participant Flow|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
315525|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
315526|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
315527|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
315528|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
315529|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
315530|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
315531|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
315532|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
315533|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
315534|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
315535|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
315536|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
315537|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
315538|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
315539|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
315540|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
328560|NCT00296374|O3|Outcome|Atorvastatin 80mg|
315541|NCT00249821|E2|Reported Event|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
315542|NCT00249821|E1|Reported Event|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
315543|NCT00249873|B3|Baseline|Total|Total of all reporting groups
315544|NCT00249873|B2|Baseline|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
315545|NCT00249873|B1|Baseline|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
315546|NCT00249873|P2|Participant Flow|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
315547|NCT00249873|P1|Participant Flow|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
315548|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
315549|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
315550|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
315551|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
315552|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
315553|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
315554|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
315555|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
315556|NCT00249873|E2|Reported Event|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
315557|NCT00249873|E1|Reported Event|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
315558|NCT00243347|B1|Baseline|Cediranib 30 mg|Cediranib 30mg/Day
315559|NCT00243347|P1|Participant Flow|Cediranib 30 mg|Cediranib 30mg/Day
315560|NCT00243347|O1|Outcome|Cediranib 30 mg|Cediranib 30mg/Day
315561|NCT00243347|O1|Outcome|Cediranib 30 mg|Cediranib 30mg/Day
315562|NCT00243347|E1|Reported Event|Cediranib 30 mg|Cediranib 30mg/Day
315563|NCT00243386|B1|Baseline|All Study Participants|Participants first underwent an open-label evaluation of rAHF-PFM PK. 48 hours after the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1). After completing the on-demand treatment, participants were randomized to 1 of 2 prophylactic regimens for 12 months ±2 weeks (Part 2). The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
315565|NCT00243386|P2|Participant Flow|PK-Driven Prophylaxis|The PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg of rAHF-PFM every 72 ±6 hours
315566|NCT00243386|P1|Participant Flow|All Study Participants|Participants first underwent an open-label pharmacokinetic (PK) evaluation of rAHF-PFM. 48 hours after the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1). After completing the on-demand treatment, participants were randomized to 1 of 2 prophylactic regimens for 12 months ±2 weeks (Part 2). The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
315567|NCT00243386|O4|Outcome|Any Prophylaxis|Either Standard or PK-driven Prophylaxis
315568|NCT00243386|O3|Outcome|PK-driven Prophylaxis|Dosed at 20 to 80 IU/kg every 72 ±6 hours for 12 months (Part 2)
315569|NCT00243386|O2|Outcome|Standard Prophylaxis|Dosed at 20 to 40 IU/kg every 48 ±6 hours for 12 months (Part 2)
315570|NCT00243386|O1|Outcome|On-Demand Regimen|After the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1)
315571|NCT00243386|O1|Outcome|≥14 Years of Age|After an on-demand treatment period, participants were randomized to 1 of 2 prophylactic regimens for 12 months. The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
315572|NCT00243386|O1|Outcome|≥14 Years of Age|After an on-demand treatment period, participants were randomized to 1 of 2 prophylactic regimens for 12 months. The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
315573|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
315574|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
315575|NCT00243386|O3|Outcome|On-Demand to Any Prophylaxis Treatment|
315576|NCT00243386|O2|Outcome|On-Demand to PK-Driven Prophylaxis|
315577|NCT00243386|O1|Outcome|On-Demand to Standard Prophylaxis|
315578|NCT00243386|O4|Outcome|Any Prophylaxis Treatment|Any Prophylaxis Treatment (either Standard Prophylaxis or PK-Driven Prophylaxis) Standard Prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator PK-Driven Prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
315579|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
315580|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
328561|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
315581|NCT00243386|O1|Outcome|On-Demand Treatment|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours
315582|NCT00243386|O1|Outcome|Assessed Before Treatment|
315583|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
315584|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
315585|NCT00243386|O1|Outcome|On-Demand|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours
315586|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to investigational product (IP)
315587|NCT00243386|O4|Outcome|SAEs Outside of the 3 Treatment Arms|Participants with SAEs that occurred after exposure to investigational product, but outside of the three treatment arms
315588|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
315589|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
315590|NCT00243386|O1|Outcome|On-Demand|
315591|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
315592|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
315593|NCT00243386|O1|Outcome|On-Demand|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
315594|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to IP
315595|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to IP
315596|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to Investigational Product (IP)
315597|NCT00243386|O2|Outcome|<14 Years of Age|
315598|NCT00243386|O1|Outcome|≥14 Years of Age|
315599|NCT00243386|O2|Outcome|<14 Years of Age|
315600|NCT00243386|O1|Outcome|≥14 Years of Age|
315601|NCT00243386|O2|Outcome|<14 Years of Age|
315602|NCT00243386|O1|Outcome|≥14 Years of Age|
315603|NCT00243386|O2|Outcome|<14 Years of Age|
315604|NCT00243386|O1|Outcome|≥14 Years of Age|
315605|NCT00243386|O2|Outcome|<14 Years of Age|
315606|NCT00243386|O1|Outcome|≥14 Years of Age|
315607|NCT00243386|O2|Outcome|<14 Years of Age|
315608|NCT00243386|O1|Outcome|≥14 Years of Age|
315609|NCT00243386|O2|Outcome|<14 Years of Age|
315610|NCT00243386|O1|Outcome|≥14 Years of Age|
315611|NCT00243386|O2|Outcome|<14 Years of Age|
315612|NCT00243386|O1|Outcome|≥14 Years of Age|
315613|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
315614|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
315615|NCT00243386|O1|Outcome|On-Demand Regimen|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
315616|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
315617|NCT00243386|O2|Outcome|Standard Prophylaxis Treatment|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
315618|NCT00243386|O1|Outcome|On-Demand Treatment|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
315619|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
315620|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
315621|NCT00243386|O1|Outcome|On-Demand Versus Any Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
Prophylaxis:
Standard prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
PK-driven prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor"
315622|NCT00243386|O1|Outcome|On-Demand Versus PK-Driven Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
PK-driven prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor"
315623|NCT00243386|O1|Outcome|On-Demand Versus Standard Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, Gastrointestinal (GI), and intracranial (60-100 IU/kg every 8-12 hours)
Standard Prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator"
315624|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
315625|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
315626|NCT00243386|E4|Reported Event|SAEs Outside of the 3 Treatment Arms|Participants with SAEs that occurred after exposure to investigational product, but outside of the three treatment arms
315627|NCT00243386|E3|Reported Event|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg (every 72 ±6 hours) exact regimen to be determined by the sponsor
315628|NCT00243386|E2|Reported Event|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg (every 48 ±6 hours), exact regimen to be determined by the investigator
315629|NCT00243386|E1|Reported Event|On-Demand|On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
315630|NCT00243412|B3|Baseline|Total|Total of all reporting groups
315631|NCT00243412|B2|Baseline|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315632|NCT00243412|B1|Baseline|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315633|NCT00243412|P2|Participant Flow|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion, For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315634|NCT00243412|P1|Participant Flow|Arm A: 500 mg Rituximab|Rituximab: 1000 mg intravenous (IV) on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315766|NCT00250276|E4|Reported Event|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315635|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315636|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315637|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315638|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315639|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315640|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315641|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315642|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315643|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315644|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315645|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315646|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315647|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315648|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315649|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315815|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
315816|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
315650|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315651|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315652|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315653|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315654|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315655|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315656|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315684|NCT00243659|E1|Reported Event|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
315685|NCT00250276|B5|Baseline|Total|Total of all reporting groups
315998|NCT00251225|O1|Outcome|Hormone Refractory Prostate Cancer Patients|Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
315657|NCT00243412|E2|Reported Event|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315658|NCT00243412|E1|Reported Event|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
315659|NCT00243503|B1|Baseline|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315660|NCT00243503|P1|Participant Flow|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315661|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315662|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315663|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315664|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315665|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315666|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315667|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315668|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315669|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315670|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315671|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles
315672|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315673|NCT00243503|E1|Reported Event|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
315674|NCT00243659|B3|Baseline|Total|Total of all reporting groups
315675|NCT00243659|B2|Baseline|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
315676|NCT00243659|B1|Baseline|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
315677|NCT00243659|P2|Participant Flow|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
315678|NCT00243659|P1|Participant Flow|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
315679|NCT00243659|O2|Outcome|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
315680|NCT00243659|O1|Outcome|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
315681|NCT00243659|O2|Outcome|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
315682|NCT00243659|O1|Outcome|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
315683|NCT00243659|E2|Reported Event|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
315686|NCT00250276|B4|Baseline|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315687|NCT00250276|B3|Baseline|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315688|NCT00250276|B2|Baseline|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315689|NCT00250276|B1|Baseline|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315690|NCT00250276|P4|Participant Flow|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315691|NCT00250276|P3|Participant Flow|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315692|NCT00250276|P2|Participant Flow|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315693|NCT00250276|P1|Participant Flow|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315817|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
315818|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
315819|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
315694|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315695|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315696|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315697|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315698|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315699|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315700|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315701|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315702|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315703|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315704|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315705|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315706|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315707|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315708|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315709|NCT00250276|O2|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured at lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315710|NCT00250276|O1|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315711|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315712|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315820|NCT00250497|E2|Reported Event|Control Group|All Girls PE Control Group
315821|NCT00250497|E1|Reported Event|Intervention Group|New Moves Intervention Group
315822|NCT00250588|B4|Baseline|Total|Total of all reporting groups
315713|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315714|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315715|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315716|NCT00250276|O2|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured at lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315717|NCT00250276|O1|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315718|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315719|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315720|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315721|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315722|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315793|NCT00250484|B2|Baseline|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.
Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
315723|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315724|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315725|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315726|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315727|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315728|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315729|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315730|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315823|NCT00250588|B3|Baseline|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
315731|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315732|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315733|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315734|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315735|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315736|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315737|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315738|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315739|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315740|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315741|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
328562|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
315742|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315743|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315744|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315745|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315746|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315747|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315748|NCT00250276|O4|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315844|NCT00250679|B1|Baseline|Formoterol 12 Mcg 2x/Day|
315845|NCT00250679|P3|Participant Flow|Arformoterol 25 Mcg 2x/Day|
315846|NCT00250679|P2|Participant Flow|Arformoterol 15 Mcg 2x/Day|
315749|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315750|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315751|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315752|NCT00250276|O4|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315753|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315754|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315755|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315756|NCT00250276|O4|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315757|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315758|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315794|NCT00250484|B1|Baseline|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.
Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
328563|NCT00296374|O3|Outcome|Atorvastatin 80mg|
315759|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315760|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315761|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
315762|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315763|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315764|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315765|NCT00250276|E5|Reported Event|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315767|NCT00250276|E3|Reported Event|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315768|NCT00250276|E2|Reported Event|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315769|NCT00250276|E1|Reported Event|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
315770|NCT00250432|B3|Baseline|Total|Total of all reporting groups
315771|NCT00250432|B2|Baseline|Caspofungin 150 mg|Caspofungin 150 mg IV daily
315772|NCT00250432|B1|Baseline|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
315773|NCT00250432|P2|Participant Flow|Caspofungin 150 mg|Caspofungin 150 mg IV daily
315774|NCT00250432|P1|Participant Flow|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
315775|NCT00250432|O2|Outcome|Caspofungin 150 mg|Caspofungin 150 mg IV daily
315776|NCT00250432|O1|Outcome|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
315777|NCT00250432|O2|Outcome|Caspofungin 150 mg|Caspofungin 150 mg IV daily
315778|NCT00250432|O1|Outcome|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
315779|NCT00250432|E2|Reported Event|Caspofungin 150 mg|Caspofungin 150 mg IV daily
315780|NCT00250432|E1|Reported Event|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
315781|NCT00250458|B3|Baseline|Total|Total of all reporting groups
315782|NCT00250458|B2|Baseline|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
315783|NCT00250458|B1|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
315784|NCT00250458|P2|Participant Flow|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
315785|NCT00250458|P1|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
315786|NCT00250458|O2|Outcome|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
315787|NCT00250458|O1|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
315788|NCT00250458|O2|Outcome|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
315789|NCT00250458|O1|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
315790|NCT00250458|E2|Reported Event|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
315791|NCT00250458|E1|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
315792|NCT00250484|B3|Baseline|Total|Total of all reporting groups
315896|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315795|NCT00250484|P2|Participant Flow|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.
Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
315796|NCT00250484|P1|Participant Flow|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.
Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
315797|NCT00250484|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.
Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
315798|NCT00250484|O1|Outcome|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.
Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
315799|NCT00250484|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.
Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
315800|NCT00250484|O1|Outcome|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.
Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
315801|NCT00250484|E2|Reported Event|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.
Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
315802|NCT00250484|E1|Reported Event|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.
Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
315803|NCT00250497|B3|Baseline|Total|Total of all reporting groups
315804|NCT00250497|B2|Baseline|Control Group|All Girls PE Control Group
315805|NCT00250497|B1|Baseline|Intervention Group|New Moves Intervention
315806|NCT00250497|P2|Participant Flow|Control Group|All Girls PE Control group
315807|NCT00250497|P1|Participant Flow|Intervention Group|New Moves Intervention
315808|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
315809|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
315810|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
315811|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
315812|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
315813|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
315814|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
315824|NCT00250588|B2|Baseline|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework – identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework – defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework – implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
315825|NCT00250588|B1|Baseline|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor’s level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
315826|NCT00250588|P3|Participant Flow|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
315827|NCT00250588|P2|Participant Flow|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
315897|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315898|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315828|NCT00250588|P1|Participant Flow|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
315829|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
315830|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
315831|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
315832|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
315847|NCT00250679|P1|Participant Flow|Formoterol 12 Mcg 2x/Day|
315848|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315849|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315850|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315851|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315852|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315853|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315854|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315833|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
315834|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
315835|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
315836|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
315899|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315900|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315901|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315902|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315903|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315904|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315905|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315906|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315907|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315908|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315909|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315837|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
315838|NCT00250588|E3|Reported Event|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
315839|NCT00250588|E2|Reported Event|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
315840|NCT00250588|E1|Reported Event|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
315841|NCT00250679|B4|Baseline|Total|Total of all reporting groups
315842|NCT00250679|B3|Baseline|Arformoterol 25 Mcg 2x/Day|
315843|NCT00250679|B2|Baseline|Arformoterol 15 Mcg 2x/Day|
315879|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315880|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315881|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315882|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315883|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315884|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315885|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315886|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315887|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315888|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315889|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315890|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315891|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315892|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315893|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
315894|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
315895|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
315944|NCT00250705|B1|Baseline|Aripiprazole Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
315945|NCT00250705|P1|Participant Flow|Aripiprazole Treatment of Conduct Disorde|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000). The initial aripiprazole dose depending on the weight of the patient was: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose was individualized based on the response and tolerance to the drug with a maximum aripiprazole dose of 20 mg/d. Current psychotropic medications were not washed out of the patients at the beginning of the study due to the exploratory stage of use of the drug for the conduct disorder indication.
315946|NCT00250705|O1|Outcome|Aripiprazole Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
315947|NCT00250705|O1|Outcome|Adolescent Conduct Disorder Males|"All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.
Aripiprazole: The initial dose depending on the weight of the patient will be as follows: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. The dose was individualized based on response and tolerance with a maximum of 20 mg per day."
315948|NCT00250705|O1|Outcome|Aripiprazole Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
315949|NCT00250705|O1|Outcome|Adolescent Conduct Disorder Males|"All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.
Aripiprazole: The initial dose depending on the weight of the patient will be as follows: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. The dose was individualized based on response and tolerance with a maximum of 20 mg per day."
315950|NCT00250705|O1|Outcome|Aripiprazole Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 10 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000). The initial aripiprazole dose depending on the weight of the patient was: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose was individualized based on the response and tolerance to the drug with a maximum aripiprazole dose of 20 mg/d. Current psychotropic medications were not washed out of the patients at the beginning of the study due to the exploratory stage of use of the drug for the conduct disorder indication.
315951|NCT00250705|E1|Reported Event|Aripiprazole in the Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
315952|NCT00250718|B1|Baseline|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily
One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
315953|NCT00250718|P1|Participant Flow|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily
One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
315954|NCT00250718|O1|Outcome|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily
One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
315955|NCT00250718|O1|Outcome|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily
One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
316174|NCT00251758|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
315956|NCT00250718|E1|Reported Event|Arm 1 Combination Treatment|"VP-16 50mg/d PO x14 days q 28 days + Chlorambucil 0.1mg/kg/d PO x14 days q 28 days + Vincristine 2mg IV x14 days + Dexamethasone 200mg IV q 24 days + Rituxan (rituximab) 375 mg/m2 IVI x14 days + Levofloxacin 500 mg PO qd + Diflucan 200 mg PO qd
Vincristine: should be administered intravenously through a freely-running IV at 2mg q 14 days.
VP-16: The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. Dose and schedule 50 mg/d P.O. x14 days q 28 days.
Rituximab: The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted.
Dexamethasone: Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
Levofloxacin: Levofloxacin will be administ"
315999|NCT00251225|O1|Outcome|Hormone Refractory Prostate Cancer Patients|Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
316000|NCT00251225|E1|Reported Event|Hormone Refractory Prostate Cancer Patients|Patients with hormone refractory prostate cancer treated with Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
315957|NCT00250835|B1|Baseline|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.
Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).
Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.
Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
315958|NCT00250835|P1|Participant Flow|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.
Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).
Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.
Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
315959|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.
Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).
Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.
Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
315960|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.
Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).
Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.
Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
315961|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.
Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).
Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.
Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
315962|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.
Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).
Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.
Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
315963|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.
Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).
Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.
Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
315964|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.
Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).
Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.
Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
315965|NCT00250835|E1|Reported Event|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.
Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).
Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.
Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
315966|NCT00250926|B1|Baseline|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
316112|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
315967|NCT00250926|P1|Participant Flow|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
315968|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|"A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
Bortezomib: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
Dexamethasone: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
Rituximab: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles"
315983|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315969|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|"A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
Bortezomib: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
Dexamethasone: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
Rituximab: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles"
315970|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
315971|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
315972|NCT00250926|E1|Reported Event|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
315973|NCT00251004|B4|Baseline|Total|Total of all reporting groups
315974|NCT00251004|B3|Baseline|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315975|NCT00251004|B2|Baseline|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315976|NCT00251004|B1|Baseline|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315977|NCT00251004|P3|Participant Flow|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315978|NCT00251004|P2|Participant Flow|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315979|NCT00251004|P1|Participant Flow|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
316041|NCT00251589|P2|Participant Flow|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
315980|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315981|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315982|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
316001|NCT00251238|B3|Baseline|Total|Total of all reporting groups
315984|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315985|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315986|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315987|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315988|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315989|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315990|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315991|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
316042|NCT00251589|P1|Participant Flow|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
316361|NCT00252239|O2|Outcome|TNK 0.25 mg/kg|Medium dose tenecteplase
315992|NCT00251004|E3|Reported Event|Control Group|"1.44 g Mycophenolic Acid (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315993|NCT00251004|E2|Reported Event|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315994|NCT00251004|E1|Reported Event|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
315995|NCT00251225|B1|Baseline|Hormone Refractory Prostate Cancer Patients|Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
315996|NCT00251225|P1|Participant Flow|Hormone Refractory Prostate Cancer Patients|Patients with hormone refractory prostate cancer treated with Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
315997|NCT00251225|O1|Outcome|Hormone Refractory Prostate Cancer Patients|Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
316003|NCT00251238|B1|Baseline|Intervention Group|active treatment group, receiving film coated 120 mg Ginkgo Biloba special extract (EGb 761) two times a day for 10 weeks
316004|NCT00251238|P2|Participant Flow|Placebo Group|receiving matching placebo
316005|NCT00251238|P1|Participant Flow|Intervention Group|active treatment group, receiving oral film-coated tablet of 120-mg Ginkgo Biloba special extract (EGb 761) 2 times a day for 10 weeks, after an initial 2-week run-in phase
316006|NCT00251238|O2|Outcome|Placebo Group|receiving placebo
316007|NCT00251238|O1|Outcome|Intervention Group|active treatment group (EGb 761)
316008|NCT00251238|O2|Outcome|Placebo Group|receiving placebo
316009|NCT00251238|O1|Outcome|Intervention Group|active treatment group (EGb 761)
316010|NCT00251238|O2|Outcome|Placebo Group|receiving placebo
316011|NCT00251238|O1|Outcome|Intervention Group|active treatment group (EGb 761)
316012|NCT00251238|E2|Reported Event|Placebo Group|receiving placebo
316013|NCT00251238|E1|Reported Event|Intervention Group|active treatment group (EGb 761)
316014|NCT00251303|B3|Baseline|Total|Total of all reporting groups
316015|NCT00251303|B2|Baseline|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.
Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
316016|NCT00251303|B1|Baseline|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.
Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
316017|NCT00251303|P2|Participant Flow|Placebo|Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms.
316018|NCT00251303|P1|Participant Flow|Riluzole|Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day.
316019|NCT00251303|O2|Outcome|Placebo|Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms.
316020|NCT00251303|O1|Outcome|Riluzole|Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day.
316021|NCT00251303|O2|Outcome|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.
Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
316043|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
316113|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316022|NCT00251303|O1|Outcome|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.
Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
316023|NCT00251303|E2|Reported Event|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.
Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
316024|NCT00251303|E1|Reported Event|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.
Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
316025|NCT00251316|B3|Baseline|Total|Total of all reporting groups
316026|NCT00251316|B2|Baseline|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
316027|NCT00251316|B1|Baseline|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
316132|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316028|NCT00251316|P2|Participant Flow|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
316029|NCT00251316|P1|Participant Flow|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
316030|NCT00251316|O2|Outcome|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
316031|NCT00251316|O1|Outcome|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
316032|NCT00251316|E2|Reported Event|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
316033|NCT00251316|E1|Reported Event|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
316034|NCT00251589|B5|Baseline|Total|Total of all reporting groups
316035|NCT00251589|B4|Baseline|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
316036|NCT00251589|B3|Baseline|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316037|NCT00251589|B2|Baseline|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316038|NCT00251589|B1|Baseline|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
316039|NCT00251589|P4|Participant Flow|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
316040|NCT00251589|P3|Participant Flow|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316044|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
316045|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316046|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316047|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
316126|NCT00251719|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316127|NCT00251719|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316048|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
316049|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316050|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316051|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
316052|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
316053|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316054|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316055|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
316056|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
316057|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316058|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316059|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
316060|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
316061|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316111|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316062|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316063|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
316064|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
316065|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316066|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316128|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316067|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
316068|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
316069|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316070|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316071|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
316072|NCT00251589|E4|Reported Event|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
316073|NCT00251589|E3|Reported Event|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316074|NCT00251589|E2|Reported Event|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
316075|NCT00251589|E1|Reported Event|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
316076|NCT00251641|B3|Baseline|Total|Total of all reporting groups
316077|NCT00251641|B2|Baseline|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
316078|NCT00251641|B1|Baseline|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
316079|NCT00251641|P2|Participant Flow|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
316080|NCT00251641|P1|Participant Flow|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
316362|NCT00252239|O1|Outcome|TNK 0.1 mg/kg|Lowest dose tenecteplase
316081|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
316082|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
316083|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
316084|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
316129|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316130|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316131|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316085|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
316086|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
316087|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
316088|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
316089|NCT00251641|E4|Reported Event|Participants Who Switched From Methotrexate to Infliximab|Adverse events reported for participants who switched from methotrexate to infliximab at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
316090|NCT00251641|E3|Reported Event|Participants Who Switched From Infliximab to Methotrexate|Adverse events reported for participants who switched from infliximab to methotrexate at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
316091|NCT00251641|E2|Reported Event|Methotrexate|Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
316092|NCT00251641|E1|Reported Event|Infliximab|Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
316093|NCT00251693|B4|Baseline|Total|Total of all reporting groups
316094|NCT00251693|B3|Baseline|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316095|NCT00251693|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316096|NCT00251693|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316097|NCT00251693|P3|Participant Flow|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316098|NCT00251693|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316099|NCT00251693|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316100|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316101|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316102|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316103|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316104|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316105|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316106|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316107|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316108|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316109|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316110|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316114|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316115|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316116|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316117|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316118|NCT00251693|E3|Reported Event|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316119|NCT00251693|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316120|NCT00251693|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316121|NCT00251719|B4|Baseline|Total|Total of all reporting groups
316122|NCT00251719|B3|Baseline|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316123|NCT00251719|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316124|NCT00251719|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316125|NCT00251719|P3|Participant Flow|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316133|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316134|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316135|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316136|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316137|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316138|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316139|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316140|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316141|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316142|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316143|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316144|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316145|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316146|NCT00251719|E3|Reported Event|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
316147|NCT00251719|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
316148|NCT00251719|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
316149|NCT00251745|B4|Baseline|Total|Total of all reporting groups
316150|NCT00251745|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316151|NCT00251745|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316152|NCT00251745|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316153|NCT00251745|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316154|NCT00251745|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316155|NCT00251745|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316156|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316157|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316158|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316159|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316160|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316161|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316162|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316163|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316164|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316165|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316166|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316167|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316168|NCT00251745|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316169|NCT00251745|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316170|NCT00251745|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316171|NCT00251758|B4|Baseline|Total|Total of all reporting groups
316172|NCT00251758|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316173|NCT00251758|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316175|NCT00251758|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316176|NCT00251758|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316177|NCT00251758|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316178|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316179|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316180|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316181|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316182|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316183|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316184|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316185|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316186|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316187|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316188|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316189|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316190|NCT00251758|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
316191|NCT00251758|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
316192|NCT00251758|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
316193|NCT00251862|B4|Baseline|Total|Total of all reporting groups
316194|NCT00251862|B3|Baseline|Control|Standard Care
316195|NCT00251862|B2|Baseline|DA Alone|Decision aid alone
316196|NCT00251862|B1|Baseline|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
316197|NCT00251862|P3|Participant Flow|Control|Standard Care
316198|NCT00251862|P2|Participant Flow|DA Alone|Decision aid alone
316199|NCT00251862|P1|Participant Flow|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
316200|NCT00251862|O3|Outcome|Control|Standard Care
316201|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
316202|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
316203|NCT00251862|O3|Outcome|Control|Standard Care
316204|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
316205|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
316206|NCT00251862|O3|Outcome|Control|Standard Care
316207|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
316208|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
316209|NCT00251862|O3|Outcome|Control|Standard Care
316210|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
316211|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
316212|NCT00251862|E3|Reported Event|Control|Standard Care
316213|NCT00251862|E2|Reported Event|DA Alone|Decision aid alone
316214|NCT00251862|E1|Reported Event|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
316215|NCT00251927|B3|Baseline|Total|Total of all reporting groups
316216|NCT00251927|B2|Baseline|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316217|NCT00251927|B1|Baseline|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316218|NCT00251927|P2|Participant Flow|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316219|NCT00251927|P1|Participant Flow|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316220|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316221|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316222|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316223|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316224|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316225|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316226|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316227|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316509|NCT00252967|P1|Participant Flow|Placebo|
316228|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316229|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316230|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316231|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316232|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316233|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316234|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316372|NCT00252499|B4|Baseline|Total|Total of all reporting groups
316235|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316236|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316237|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316238|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316239|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316240|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316241|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316242|NCT00251927|E3|Reported Event|Non-Surgical Arm|This group of patients was randomized to receive surgery but were on operated on and were followed for safety purposes
316243|NCT00251927|E2|Reported Event|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
316244|NCT00251927|E1|Reported Event|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
316245|NCT00251979|B3|Baseline|Total|Total of all reporting groups
316246|NCT00251979|B2|Baseline|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316247|NCT00251979|B1|Baseline|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316248|NCT00251979|P2|Participant Flow|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316249|NCT00251979|P1|Participant Flow|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316250|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316251|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316252|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316253|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316254|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316255|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316256|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316257|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316258|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316259|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316260|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316261|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316262|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316263|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316264|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316265|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316266|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316267|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316268|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316269|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316270|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316271|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316272|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316273|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316274|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316275|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316276|NCT00251979|E2|Reported Event|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316277|NCT00251979|E1|Reported Event|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
316278|NCT00252057|B3|Baseline|Total|Total of all reporting groups
316279|NCT00252057|B2|Baseline|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
316280|NCT00252057|B1|Baseline|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
316281|NCT00252057|P2|Participant Flow|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
316282|NCT00252057|P1|Participant Flow|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
316283|NCT00252057|O2|Outcome|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
316284|NCT00252057|O1|Outcome|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
316285|NCT00252057|E2|Reported Event|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
316286|NCT00252057|E1|Reported Event|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
316287|NCT00252174|B4|Baseline|Total|Total of all reporting groups
316288|NCT00252174|B3|Baseline|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316289|NCT00252174|B2|Baseline|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316290|NCT00252174|B1|Baseline|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316291|NCT00252174|P3|Participant Flow|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316292|NCT00252174|P2|Participant Flow|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316293|NCT00252174|P1|Participant Flow|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316294|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316295|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316355|NCT00252239|P4|Participant Flow|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA
tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
316356|NCT00252239|P3|Participant Flow|TNK 0.4 mg/kg|Highest dose tenecteplase
316510|NCT00252967|O2|Outcome|Atorvastatin|
316296|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316297|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316298|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316373|NCT00252499|B3|Baseline|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
316374|NCT00252499|B2|Baseline|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
316375|NCT00252499|B1|Baseline|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
316299|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316300|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316301|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316302|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316303|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316304|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316305|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316306|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316307|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316308|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316309|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316310|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316311|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316376|NCT00252499|P3|Participant Flow|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
316377|NCT00252499|P2|Participant Flow|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
316380|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
316312|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316313|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316314|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316315|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316316|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316317|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316318|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316319|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316320|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316357|NCT00252239|P2|Participant Flow|TNK 0.25 mg/kg|Medium dose tenecteplase
316358|NCT00252239|P1|Participant Flow|TNK 0.1 mg/kg|Lowest dose tenecteplase
316359|NCT00252239|O4|Outcome|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA
tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
316360|NCT00252239|O3|Outcome|TNK 0.4 mg/kg|Highest dose tenecteplase
316321|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316322|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316323|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316324|NCT00252174|E3|Reported Event|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316378|NCT00252499|P1|Participant Flow|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
316379|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
316325|NCT00252174|E2|Reported Event|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule
Dosage frequency and duration for the control arm (4 subjects):
Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
316326|NCT00252174|E1|Reported Event|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule
Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
316327|NCT00252187|B3|Baseline|Total|Total of all reporting groups
316328|NCT00252187|B2|Baseline|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
316329|NCT00252187|B1|Baseline|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
316330|NCT00252187|P2|Participant Flow|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
316331|NCT00252187|P1|Participant Flow|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
316332|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
316333|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
316334|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
316335|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
316336|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
316337|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
316338|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
316339|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
316340|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
316341|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
316342|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
316343|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
316344|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
316345|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
316346|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
316347|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
316348|NCT00252187|E2|Reported Event|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks
316349|NCT00252187|E1|Reported Event|BPN Group|BNP (nesiritide) administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
316350|NCT00252239|B5|Baseline|Total|Total of all reporting groups
316351|NCT00252239|B4|Baseline|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA
tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
316352|NCT00252239|B3|Baseline|TNK 0.4 mg/kg|Highest dose tenecteplase
316353|NCT00252239|B2|Baseline|TNK 0.25 mg/kg|Medium dose tenecteplase
316354|NCT00252239|B1|Baseline|TNK 0.1 mg/kg|Lowest dose tenecteplase
316363|NCT00252239|E4|Reported Event|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA
tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
316364|NCT00252239|E3|Reported Event|TNK 0.4 mg/kg|Highest dose tenecteplase
316365|NCT00252239|E2|Reported Event|TNK 0.25 mg/kg|Medium dose tenecteplase
316366|NCT00252239|E1|Reported Event|TNK 0.1 mg/kg|Lowest dose tenecteplase
316367|NCT00252382|B1|Baseline|Total|Open label administration of SNS-595 48 mg/m2 treatment on day one of 21 day cycles, up to 6 cycles.
316368|NCT00252382|P1|Participant Flow|Treatment With 48 mg/m2 of SNS-595|"Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC)
SNS-595 Injection: Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis."
316369|NCT00252382|O1|Outcome|Total|SNS-595 48 mg/m2
316370|NCT00252382|O1|Outcome|Total|SNS-595 48 mg/m2
316371|NCT00252382|E1|Reported Event|Total|SNS-595 48 mg/m2
316381|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
316382|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
316383|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
316384|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
316385|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
316386|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
316387|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
316388|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
316389|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
316390|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
316391|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
316392|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
316393|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
316394|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
316395|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
316396|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
316397|NCT00252499|E3|Reported Event|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
316398|NCT00252499|E2|Reported Event|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
316399|NCT00252499|E1|Reported Event|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
316400|NCT00252512|B3|Baseline|Total|Total of all reporting groups
316401|NCT00252512|B2|Baseline|Placebo|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
316402|NCT00252512|B1|Baseline|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
316403|NCT00252512|P2|Participant Flow|Placebo|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
316404|NCT00252512|P1|Participant Flow|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
316405|NCT00252512|O2|Outcome|Arm 2|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
316406|NCT00252512|O1|Outcome|Arm 1|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
316407|NCT00252512|E2|Reported Event|Baseline|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
316424|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
316511|NCT00252967|O1|Outcome|Placebo|
316512|NCT00252967|O2|Outcome|Atorvastatin|
316408|NCT00252512|E1|Reported Event|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
316409|NCT00252538|B1|Baseline|Group 1|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol."
316410|NCT00252538|P2|Participant Flow|Group 2 Non MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
316532|NCT00253019|B2|Baseline|Depo Provera|Participants self-selected to receive Depo Provera
316411|NCT00252538|P1|Participant Flow|Group 1 MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
316412|NCT00252538|O2|Outcome|Group 2- no MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
316413|NCT00252538|O1|Outcome|Group 1- MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
316414|NCT00252538|E1|Reported Event|Group 1|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol."
316415|NCT00252564|B3|Baseline|Total|Total of all reporting groups
316416|NCT00252564|B2|Baseline|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
316417|NCT00252564|B1|Baseline|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle"
316418|NCT00252564|P2|Participant Flow|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
316419|NCT00252564|P1|Participant Flow|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle"
316420|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
316421|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle"
316422|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
316423|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle"
316504|NCT00252733|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
316505|NCT00252967|B3|Baseline|Total|Total of all reporting groups
316506|NCT00252967|B2|Baseline|Atorvastatin|
316425|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle"
316426|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
316427|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle"
316428|NCT00252564|E2|Reported Event|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
316429|NCT00252564|E1|Reported Event|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle"
316430|NCT00252590|B4|Baseline|Total|Total of all reporting groups
328564|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
316431|NCT00252590|B3|Baseline|Control - Treatment as Usual|"No added treatment control
Control - treatment as usual: Control group with no additional intervention"
316432|NCT00252590|B2|Baseline|Health Education|"Non-personalized didactic health-related education
Health Education: Generalized health education related to alcohol use"
316433|NCT00252590|B1|Baseline|Health Motivational Feedback|"Personalized health-related feedback
Health Motivational Feedback: Personalized feedback on health status"
316434|NCT00252590|P3|Participant Flow|Control - Treatment as Usual|"No added treatment control
Control - treatment as usual: Control group with no additional intervention"
316435|NCT00252590|P2|Participant Flow|Health Education|"Non-personalized didactic health-related education
Health Education: Generalized health education related to alcohol use provided in four once monthly 45-minute sessions. Topics for sessions include sleep, pain, cardiovascular health, and gastrointestinal health."
316436|NCT00252590|P1|Participant Flow|Health Motivational Feedback|"Personalized health-related feedback
Health Motivational Feedback: Personalized feedback on health status provided in four once monthly 45 minute sessions. Information for feedback was attained with assessments and blood serum testing."
316437|NCT00252590|O3|Outcome|Control - Treatment as Usual|"No added treatment control
Control - treatment as usual: Control group with no additional intervention"
316438|NCT00252590|O2|Outcome|Health Education|"Non-personalized didactic health-related education
Health Education: Generalized health education related to alcohol use"
316439|NCT00252590|O1|Outcome|Health Motivational Feedback|"Personalized health-related feedback
Health Motivational Feedback: Personalized feedback on health status"
316440|NCT00252590|O3|Outcome|Control - Treatment as Usual|"No added treatment control
Control - treatment as usual: Control group with no additional intervention"
316441|NCT00252590|O2|Outcome|Health Education|"Non-personalized didactic health-related education
Health Education: Generalized health education related to alcohol use"
316442|NCT00252590|O1|Outcome|Health Motivational Feedback|"Personalized health-related feedback
Health Motivational Feedback: Personalized feedback on health status"
316443|NCT00252590|E3|Reported Event|Control - Treatment as Usual|"No added treatment control
Control - treatment as usual: Control group with no additional intervention"
316444|NCT00252590|E2|Reported Event|Health Education|"Non-personalized didactic health-related education
Health Education: Generalized health education related to alcohol use"
316445|NCT00252590|E1|Reported Event|Health Motivational Feedback|"Personalized health-related feedback
Health Motivational Feedback: Personalized feedback on health status"
316446|NCT00252629|B4|Baseline|Total|Total of all reporting groups
316447|NCT00252629|B3|Baseline|Healthy Asymptomatic Control|"Eleven male veterans of first gulf war were screened for fatigue, pain and cognitive dysfunction by self report instrument.
They all score below the clinical thershold and assigned as healthy asymptomatic"
316448|NCT00252629|B2|Baseline|Sham Nasal CPAP|The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness.
316449|NCT00252629|B1|Baseline|Therapeutic Nasal CPAP|The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness.
316450|NCT00252629|P3|Participant Flow|Comparison of IFL During Sleep in GWS and Healthy|"We recruited 18 male veterans with GWS (same group that were randomized to receive CPAP treatment) and 11 asymptomatic male veterans of the first Gulf war.
All veterans had a polysomnography to determine the presence of sleep disordered breathing.
We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups."
316451|NCT00252629|P2|Participant Flow|Sham Nasal CPAP|"Nine participants assigned to receive 3 weeks of treatment during sleep with sham nasal CPAP.
Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.
We compared the change of veterans reported outcomes symptoms change before and after 3 weeks treatment period on sham nasal CPAP."
316452|NCT00252629|P1|Participant Flow|Therapeutic Nasal CPAP|"Nine participants assigned to receive 3 weeks of treatment during sleep with therapeutic nasal CPAP.
Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.
We compared the change of veterans reported outcomes symptoms change before and after 3 weeks treatment period on therapeutic nasal CPAP."
316507|NCT00252967|B1|Baseline|Placebo|
316508|NCT00252967|P2|Participant Flow|Atorvastatin|
316453|NCT00252629|O2|Outcome|Asymptomatic Male Veterans of Gulf War.|"A group of 11 asymptomatic male veterans of gulf war were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.
Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.
Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.
The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples."
316454|NCT00252629|O1|Outcome|GWS Male Group|"A group of18 male veterans with GWS were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.
Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.
Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.
The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples."
316455|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment on sham nasal CPAP
316588|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316456|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment of therapeutic nasal CPAP
316457|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of pain complaint before and after treatment of 3 weeks on sham nasal CPAP
316458|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of pain complaint before and after 3 weeks treatment of therapeutic nasal CPAP
316459|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of fatigue complaint before and after treatment of 3 weeks on sham nasal CPAP
316460|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of fatigue complaint before and after 3 weeks treatment of therapeutic nasal CPAP
316461|NCT00252629|E3|Reported Event|Comparison of IFL During Sleep in GWS and Healthy|"We recruited 11 asymptomatic male veterans of the first Gulf war. In addition to our 18 male veterans with GWS (same group that were randomized to receive CPAP treatment).
All veterans had a polysomnography to determine the presence of sleep disordered breathing.
We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups."
316462|NCT00252629|E2|Reported Event|Sham Nasal CPAP|Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on sham nasal CPAP with change of symptoms on therapeutic nasal CPAP
316463|NCT00252629|E1|Reported Event|Therapeutic Nasal CPAP|Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on therapeutic nasal CPAP with change of symptoms on sham nasal CPAP
316464|NCT00252694|B3|Baseline|Total|Total of all reporting groups
316465|NCT00252694|B2|Baseline|Placebo|Placebo Comparator
316466|NCT00252694|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
316467|NCT00252694|P2|Participant Flow|Placebo|Placebo Comparator
316468|NCT00252694|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
316469|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
316470|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
316471|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
316472|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
316473|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
316474|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
316475|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
316476|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
316477|NCT00252694|E2|Reported Event|Placebo|Placebo Comparator
316478|NCT00252694|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
316479|NCT00252720|B3|Baseline|Total|Total of all reporting groups
316480|NCT00252720|B2|Baseline|Placebo|Placebo Comparator
316481|NCT00252720|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
316482|NCT00252720|P2|Participant Flow|Placebo|Placebo Comparator
316483|NCT00252720|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
316484|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
316485|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
316486|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
316487|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
316488|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
316489|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
316490|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
316491|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
316492|NCT00252720|E2|Reported Event|Placebo|Placebo Comparator
316493|NCT00252720|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
316494|NCT00252733|B3|Baseline|Total|Total of all reporting groups
316495|NCT00252733|B2|Baseline|Placebo|Placebo Comparator
316496|NCT00252733|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
316497|NCT00252733|P2|Participant Flow|Placebo|Placebo Comparator
316498|NCT00252733|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
316499|NCT00252733|O2|Outcome|Placebo|Placebo Comparator
316500|NCT00252733|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
316501|NCT00252733|O2|Outcome|Placebo|Placebo Comparator
316502|NCT00252733|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
316503|NCT00252733|E2|Reported Event|Placebo|Placebo Comparator
316513|NCT00252967|O1|Outcome|Placebo|
316514|NCT00252967|O2|Outcome|Atorvastatin|
316515|NCT00252967|O1|Outcome|Placebo|
316516|NCT00252967|O2|Outcome|Atorvastatin|
316517|NCT00252967|O1|Outcome|Placebo|
316518|NCT00252967|O2|Outcome|Atorvastatin|
316519|NCT00252967|O1|Outcome|Placebo|
316520|NCT00252967|O2|Outcome|Atorvastatin|
316521|NCT00252967|O1|Outcome|Placebo|
316522|NCT00252967|O2|Outcome|Atorvastatin|
316523|NCT00252967|O1|Outcome|Placebo|
316524|NCT00252967|O2|Outcome|Atorvastatin|
316525|NCT00252967|O1|Outcome|Placebo|
316526|NCT00252967|O2|Outcome|Atorvastatin|
316527|NCT00252967|O1|Outcome|Placebo|
316528|NCT00252967|E2|Reported Event|Atorvastatin|
316529|NCT00252967|E1|Reported Event|Placebo|
316530|NCT00253019|B4|Baseline|Total|Total of all reporting groups
316531|NCT00253019|B3|Baseline|Ortho Evra|Participants self-selected to receive Ortho Evra.
316533|NCT00253019|B1|Baseline|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
316534|NCT00253019|P3|Participant Flow|Ortho Evra|Participants self-selected to receive Ortho Evra.
316535|NCT00253019|P2|Participant Flow|Depo Provera|Participants self-selected to receive Depo Provera
316536|NCT00253019|P1|Participant Flow|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
316537|NCT00253019|O3|Outcome|Ortho Evra|Participants self-selected to receive Ortho Evra.
316538|NCT00253019|O2|Outcome|Depo Provera|Participants self-selected to receive Depo Provera
316539|NCT00253019|O1|Outcome|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
316540|NCT00253019|E3|Reported Event|Ortho Evra|participants self-selected to receive ortho evra
316541|NCT00253019|E2|Reported Event|Depo Provera|Participants self-selected to use depo provera
316542|NCT00253019|E1|Reported Event|Oral Contraceptives|participants self-selected to take oral contraceptives
316543|NCT00246753|B1|Baseline|Single Arm Trial|"Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression"
316544|NCT00246753|P1|Participant Flow|Single Arm Trial|"Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression"
316545|NCT00246753|O1|Outcome|Single Arm Trial|"Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression"
316546|NCT00246753|O1|Outcome|Single Arm Trial|"Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression"
316547|NCT00246753|O1|Outcome|Single Arm Trial|"Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression"
316548|NCT00246753|E1|Reported Event|Single Arm Trial|"Single Arm Trial
lapatinib ditosylate: 1500 mg, daily until disease progression"
316549|NCT00246805|B3|Baseline|Total|Total of all reporting groups
316550|NCT00246805|B2|Baseline|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
316551|NCT00246805|B1|Baseline|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
316552|NCT00246805|P2|Participant Flow|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
316553|NCT00246805|P1|Participant Flow|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
316554|NCT00246805|O2|Outcome|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
316555|NCT00246805|O1|Outcome|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
316556|NCT00246805|E2|Reported Event|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
316557|NCT00246805|E1|Reported Event|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
316558|NCT00247273|B3|Baseline|Total|Total of all reporting groups
316559|NCT00247273|B2|Baseline|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316560|NCT00247273|B1|Baseline|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316561|NCT00247273|P2|Participant Flow|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316562|NCT00247273|P1|Participant Flow|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316563|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316564|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316565|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316566|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316567|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316568|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316569|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316570|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316571|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316572|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316573|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316574|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316575|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316576|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316577|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316578|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316579|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316580|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316581|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316582|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316583|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316584|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316585|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316586|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316587|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316589|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316590|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316591|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316592|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316593|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316594|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316595|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316596|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316597|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316598|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316599|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316600|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316601|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316602|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316603|NCT00247273|E2|Reported Event|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
316604|NCT00247273|E1|Reported Event|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
316605|NCT00247377|B3|Baseline|Total|Total of all reporting groups
316606|NCT00247377|B2|Baseline|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316607|NCT00247377|B1|Baseline|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316608|NCT00247377|P2|Participant Flow|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316609|NCT00247377|P1|Participant Flow|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316610|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316611|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316612|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316613|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316614|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316615|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316616|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316617|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316618|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316619|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316620|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316621|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316622|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316623|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316624|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316625|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316626|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316627|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316628|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316629|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316630|NCT00247377|E2|Reported Event|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
316631|NCT00247377|E1|Reported Event|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
316632|NCT00247416|B3|Baseline|Total|Total of all reporting groups
316686|NCT00254072|B3|Baseline|Total|Total of all reporting groups
316687|NCT00254072|B2|Baseline|Larger Stapler|4.8 mm Circular Stapler
316688|NCT00254072|B1|Baseline|Smaller Stapler|3.5 mm Circular Stapler
316633|NCT00247416|B2|Baseline|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
316634|NCT00247416|B1|Baseline|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
316635|NCT00247416|P2|Participant Flow|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
316636|NCT00247416|P1|Participant Flow|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
316703|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316704|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
316637|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
316638|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
316639|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
316640|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
316641|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
316642|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
316643|NCT00247416|O2|Outcome|2 Dex|"Dexamethasone
Gemcitabine: Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.
Dexamethasone: 16 mg bid for 4 days prior to each chemotherapy start.
Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5."
316644|NCT00247416|O1|Outcome|1 No Dex|"No Dexamethasone
Gemcitabine: Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.
Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5."
316645|NCT00247416|E2|Reported Event|2 Dexamethasone|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
316646|NCT00247416|E1|Reported Event|1 No Dexamethasone|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
316647|NCT00253747|B3|Baseline|Total|Total of all reporting groups
316648|NCT00253747|B2|Baseline|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
316649|NCT00253747|B1|Baseline|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
316650|NCT00253747|P2|Participant Flow|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316651|NCT00253747|P1|Participant Flow|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316652|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316653|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316654|NCT00253747|O10|Outcome|Methylphenidate (OROS-MPH) - Placebo-Week 9|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316689|NCT00254072|P2|Participant Flow|Larger Stapler|4.8 mm Circular Stapler
316690|NCT00254072|P1|Participant Flow|Smaller Stapler|3.5 mm Circular Stapler
316655|NCT00253747|O9|Outcome|Release Methylphenidate (OROS-MPH)-Week 9|OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316656|NCT00253747|O8|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 7|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316657|NCT00253747|O7|Outcome|Release Methylphenidate (OROS-MPH)-Week 7|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316658|NCT00253747|O6|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 4|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316705|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316706|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
316659|NCT00253747|O5|Outcome|Release Methylphenidate (OROS-MPH)-Week 4|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316660|NCT00253747|O4|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 11|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316661|NCT00253747|O3|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)-Week 11|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316662|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Baseline|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316663|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)-Baseline|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316664|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316665|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
316666|NCT00253747|E2|Reported Event|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
316667|NCT00253747|E1|Reported Event|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
316668|NCT00253890|B3|Baseline|Total|Total of all reporting groups
316669|NCT00253890|B2|Baseline|Placebo|1-3 at bedtime
316670|NCT00253890|B1|Baseline|Trazodone|50-150mg at bedtime
316671|NCT00253890|P2|Participant Flow|Placebo|1-3 capsules at bedtime
316672|NCT00253890|P1|Participant Flow|Trazodone|50-150mg at bedtime
316673|NCT00253890|O2|Outcome|Placebo|1-3 capsules at bedtime
316674|NCT00253890|O1|Outcome|Trazodone|50-150mg at bedtime
316675|NCT00253890|E2|Reported Event|Placebo|1-3 at bedtime
316676|NCT00253890|E1|Reported Event|Trazodone|50-150mg at bedtime
316677|NCT00253981|B3|Baseline|Total|Total of all reporting groups
316678|NCT00253981|B2|Baseline|Control|The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
316679|NCT00253981|B1|Baseline|Experimental|The experimental group received the monochromatic light infrared energy treatment (MIRE).
316680|NCT00253981|P2|Participant Flow|Standard of Care|Standard of care was characterized by the use of standard medical treatment to include medication.
316681|NCT00253981|P1|Participant Flow|Infrared Light Therapy|Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
316682|NCT00253981|O2|Outcome|Standard of Care|Standard of care was characterized by the use of standard medical treatment to include medication.
316683|NCT00253981|O1|Outcome|Infrared Light Therapy|Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
316684|NCT00253981|E2|Reported Event|Control|The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
316685|NCT00253981|E1|Reported Event|Experimental|The experimental group received the monochromatic light infrared red energy treatment (MIRE).
316691|NCT00254072|O2|Outcome|Larger Stapler|4.8 mm Circular Stapler
316692|NCT00254072|O1|Outcome|Smaller Stapler|3.5 mm Circular Stapler
316693|NCT00254072|E2|Reported Event|Larger Stapler|4.8 mm Circular Stapler
316694|NCT00254072|E1|Reported Event|Smaller Stapler|3.5 mm Circular Stapler
316695|NCT00254163|B3|Baseline|Total|Total of all reporting groups
316696|NCT00254163|B2|Baseline|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
316697|NCT00254163|B1|Baseline|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316698|NCT00254163|P2|Participant Flow|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
316699|NCT00254163|P1|Participant Flow|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316700|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
316701|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316702|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
328565|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
316707|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316708|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
316709|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316710|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
316711|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316712|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
316713|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316714|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
316715|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316716|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
316717|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316718|NCT00254163|E2|Reported Event|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
316719|NCT00254163|E1|Reported Event|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
316720|NCT00254293|B7|Baseline|Total|Total of all reporting groups
316721|NCT00254293|B6|Baseline|Placebo|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants were rolled over to a variable dose of abatacept SC administered weekly following an IV loading dose of abatacept on Day 85.
316722|NCT00254293|B5|Baseline|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
316723|NCT00254293|B4|Baseline|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
316724|NCT00254293|B3|Baseline|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
316725|NCT00254293|B2|Baseline|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
316726|NCT00254293|B1|Baseline|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
316727|NCT00254293|P7|Participant Flow|Fixed Dose 125 mg Abatacept|Participants who completed the variable dose long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (75, 125, 200 mg SC) were rolled over into the LTE with fixed dose, irrespective of body weight: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
316728|NCT00254293|P6|Participant Flow|Placebo|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), by body weight. Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
316729|NCT00254293|P5|Participant Flow|Group 5: 1000 mg IV/200 mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo; body weight > 100 kg. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
316747|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316730|NCT00254293|P4|Participant Flow|Group 4: 1000mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo; Body weight > 100 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period); variable long term for 125 mg SC: body weight <60 to >100 kg) . Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
316731|NCT00254293|P3|Participant Flow|Group 3 : 750 mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo (body weight 60-100 kg). Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
316954|NCT00255034|O1|Outcome|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
316732|NCT00254293|P2|Participant Flow|Group 2: 500 mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo;body weight < 60 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
316733|NCT00254293|P1|Participant Flow|Group 1: 500 mg IV/75 mg SC|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); body weight < 60 kg. Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
316734|NCT00254293|O6|Outcome|LTE (Variable and Fixed Dosing Abatacept)|Long term extension (LTE) consisted of 2 periods: variable dosing of abatacept combined with DMARDS and fixed dosing abatacept combined with DMARDS. Participants were weighed prior to starting LTE (variable dosing) and dosing was assigned per body weight category. Variable dosing period required an IV loading dose prior to starting SC dosing (if participant had been randomized to placebo in the short term period). Variable dosing: 500 mg IV/75 mg SC and 500 mg IV/125 mg SC in participants less than (<)60 kg body weight; 750 mg IV/125 mg SC in participants between 60 and 100 kg body weight; 1000 mg IV/125 mg SC and 1000 mg IV/200 mg SC in participants greater than (>) 100 kg body weight. Participants were rolled over into a fixed SC dose of 125 mg per week in the fixed dosing period prior to their Year 2 anniversary visit for the study (as early as Day 533).
316735|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
316736|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
316737|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
316738|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
316739|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks)
316740|NCT00254293|O1|Outcome|SC Abatacept|Overall summary of all participants in the LTE. LTE Period consisted of a variable dose (75 mg, 125 mg, 200 mg abatacept) phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight.
316741|NCT00254293|O1|Outcome|All Treated Participants|ECG Heart Rate change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period
316742|NCT00254293|O3|Outcome|200 mg SC Abatacept|200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight >100kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
316743|NCT00254293|O2|Outcome|125 mg SC Abatacept|125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
316744|NCT00254293|O1|Outcome|75 mg SC Abatacept|variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight <60kg. At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
316745|NCT00254293|O1|Outcome|All Treated Participants|ECG change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period.
316746|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
316748|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316749|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316750|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316751|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316955|NCT00255034|E2|Reported Event|48 Weeks of Therapy|
316956|NCT00255034|E1|Reported Event|24 Weeks of Therapy|
316752|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
316753|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316754|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316755|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316756|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316757|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316758|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
316759|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316760|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316761|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316762|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316763|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316764|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
316765|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316766|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316767|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316768|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316769|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316770|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
316771|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
316772|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
316773|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
316774|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
316775|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks).
318073|NCT00263211|O2|Outcome|Observation Only|
316776|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
316777|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 200 mg SC (once weekly for 12 weeks).
316778|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
316779|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an IV loading dose of abatacept on Day 1 of 750 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
316780|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
316957|NCT00255047|B5|Baseline|Total|Total of all reporting groups
328566|NCT00296374|E3|Reported Event|Atorvastatin 80mg|
316781|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 75 mg SC (once weekly for 12 weeks).
316782|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
316783|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316784|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316785|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316786|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316787|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316788|NCT00254293|O3|Outcome|200 mg SC Abatacept (Body Weight > 100 kg)|200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (1000 mg IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
316789|NCT00254293|O2|Outcome|125 mg SC Abatacept (Body Weight <60 to >100 kg)|Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
316790|NCT00254293|O1|Outcome|75 mg SC Abatacept (Body Weight < 60 kg)|Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly), or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
316791|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
316792|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
316793|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
316794|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
316882|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316795|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
316796|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
316893|NCT00254566|E1|Reported Event|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316894|NCT00254592|B1|Baseline|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
317355|NCT00257686|E1|Reported Event|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
316797|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
316798|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
316799|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
316800|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
316801|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316802|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316803|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316804|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316805|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
316806|NCT00254293|E7|Reported Event|Placebo (ST)|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
316807|NCT00254293|E6|Reported Event|Abatacept (LT) 125 mg SC|Participants who completed the long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (as described in Groups 1 - 5) were rolled over into the LTE with fixed dose: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
316808|NCT00254293|E5|Reported Event|Abatacept 750mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
316809|NCT00254293|E4|Reported Event|Abatacept 500mg IV/75mg SC|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
316995|NCT00255086|E2|Reported Event|Control|Participants were given matching placebo
316810|NCT00254293|E3|Reported Event|Abatacept 500mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
316811|NCT00254293|E2|Reported Event|Abatacept 1000mg IV/200mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
316895|NCT00254592|P1|Participant Flow|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
316958|NCT00255047|B4|Baseline|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316812|NCT00254293|E1|Reported Event|Abatacept 1000mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
316813|NCT00254462|B3|Baseline|Total|Total of all reporting groups
316814|NCT00254462|B2|Baseline|Placebo|Recommended dosing once daily, divided dosing at investigator discretion.
316815|NCT00254462|B1|Baseline|Atomoxetine|Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.
316816|NCT00254462|P2|Participant Flow|Placebo|Recommended dosing of once per day, with divided dosing allowed at investigators discretion.
316817|NCT00254462|P1|Participant Flow|Atomoxetine|Recommended dosing of once per day, with divided dosing allowed at investigators discretion. Maximum dose of 1.8 mg/kg/day.
316818|NCT00254462|O2|Outcome|Placebo|Recommended dosing once daily, divided dose at investigator discretion.
316819|NCT00254462|O1|Outcome|Atomoxetine|Recommended dosing once daily, divided dose at investigator discretion. Maximum daily dose of 1.8 mg/kg/day.
316820|NCT00254462|O2|Outcome|Placebo|Recommended dosing once daily, allowed to give in divided dose at investigator discretion.
316821|NCT00254462|O1|Outcome|Atomoxetine|Recommended dosing once daily, allowed to give in divided dose at investigator discretion. Maximum dose of 1.8 mg/kg/day.
316822|NCT00254462|E2|Reported Event|Placebo|Recommended dosing once daily, divided dosing at investigator discretion.
316823|NCT00254462|E1|Reported Event|Atomoxetine|Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.
316824|NCT00254501|B3|Baseline|Total|Total of all reporting groups
316825|NCT00254501|B2|Baseline|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
316826|NCT00254501|B1|Baseline|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
316827|NCT00254501|P2|Participant Flow|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
316828|NCT00254501|P1|Participant Flow|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
316829|NCT00254501|O2|Outcome|EMPOWER|Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care.
316830|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
316831|NCT00254501|O2|Outcome|Pharmacists Consults Plus Out-of-pocket Cost Waiver|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
316832|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
316833|NCT00254501|O2|Outcome|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
316834|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
316877|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316996|NCT00255086|E1|Reported Event|Memantine|10mg Memantine
316835|NCT00254501|O2|Outcome|Pharmacists Consults Plus Out-of-pocket Cost Waiver|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
316836|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
316837|NCT00254501|E2|Reported Event|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
316838|NCT00254501|E1|Reported Event|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
316839|NCT00254540|B3|Baseline|Total|Total of all reporting groups
316896|NCT00254592|O1|Outcome|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
316897|NCT00254592|E1|Reported Event|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
316898|NCT00254982|B3|Baseline|Total|Total of all reporting groups
316840|NCT00254540|B2|Baseline|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316841|NCT00254540|B1|Baseline|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316842|NCT00254540|P2|Participant Flow|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316843|NCT00254540|P1|Participant Flow|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316844|NCT00254540|O1|Outcome|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
316845|NCT00254540|O1|Outcome|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
316846|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316847|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316848|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316878|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316879|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316880|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316849|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316850|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316851|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316899|NCT00254982|B2|Baseline|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
316852|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316853|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316854|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316855|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316856|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316857|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316858|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316881|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316997|NCT00255125|B3|Baseline|Total|Total of all reporting groups
316859|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316860|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316861|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316862|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316863|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316864|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316865|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316866|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316867|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
316868|NCT00254540|E1|Reported Event|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
316869|NCT00254566|B3|Baseline|Total|Total of all reporting groups
316870|NCT00254566|B2|Baseline|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316871|NCT00254566|B1|Baseline|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316872|NCT00254566|P2|Participant Flow|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316873|NCT00254566|P1|Participant Flow|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316874|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316875|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316876|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316883|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316884|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316885|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316886|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316887|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316888|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316889|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316890|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316891|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
316892|NCT00254566|E2|Reported Event|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
316900|NCT00254982|B1|Baseline|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
316901|NCT00254982|P2|Participant Flow|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
316902|NCT00254982|P1|Participant Flow|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
316903|NCT00254982|O2|Outcome|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
316904|NCT00254982|O1|Outcome|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
316905|NCT00254982|E2|Reported Event|Group 2 (Low-need)|
316906|NCT00254982|E1|Reported Event|Group 1 (High-need)|
316907|NCT00254995|B3|Baseline|Total|Total of all reporting groups
316908|NCT00254995|B2|Baseline|Control Group|"Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0–30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.
Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study."
316909|NCT00254995|B1|Baseline|Menactra Vaccine Recipients|"Kaiser Permanente members who received Menactra vaccine during the study period.
Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study."
316910|NCT00254995|P2|Participant Flow|Control Group|"Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0–30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.
Kaiser Permanente databases were used; Menactra and control vaccine were administered according to routine clinical practice."
316911|NCT00254995|P1|Participant Flow|Menactra Vaccine Recipients|"Kaiser Permanente members who received Menactra vaccine during the study period.
Kaiser Permanente databases were used; Menactra vaccine was administered according to routine clinical practice."
316912|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
316913|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study"
316914|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
316915|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study"
317338|NCT00257686|O6|Outcome|Pravastatin 40 mg|Pravastatin 40 mg once daily
316916|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
316917|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study"
316918|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
316919|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study"
316920|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
316921|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study"
316922|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
316923|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study"
316924|NCT00254995|O2|Outcome|Control Group|Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination.
316925|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study"
316926|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
316927|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study"
316928|NCT00254995|O2|Outcome|Control Group|"The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination.
The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals."
316929|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study"
316930|NCT00254995|E1|Reported Event|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
None administered in this study: N/A in this study"
316931|NCT00255008|B5|Baseline|Total|Total of all reporting groups
316932|NCT00255008|B4|Baseline|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
316933|NCT00255008|B3|Baseline|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
316934|NCT00255008|B2|Baseline|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
316935|NCT00255008|B1|Baseline|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
316936|NCT00255008|P4|Participant Flow|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
316937|NCT00255008|P3|Participant Flow|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
316938|NCT00255008|P2|Participant Flow|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
316939|NCT00255008|P1|Participant Flow|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
316940|NCT00255008|O4|Outcome|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
316941|NCT00255008|O3|Outcome|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
316942|NCT00255008|O2|Outcome|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
316943|NCT00255008|O1|Outcome|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
316944|NCT00255008|E4|Reported Event|Genotype 6,7,8,9 SEA PEG-IFN/RIB 48w|
316945|NCT00255008|E3|Reported Event|Genotype 6,7,8,9 SEA PEG-IFN/RIB 24w|
316946|NCT00255008|E2|Reported Event|Genotype 1 Caucasian PEG-IFN/RIB 48w|
316947|NCT00255008|E1|Reported Event|Genotype 1 SEA PEG-IFN/RIB 48w|
316948|NCT00255034|B3|Baseline|Total|Total of all reporting groups
316949|NCT00255034|B2|Baseline|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
316950|NCT00255034|B1|Baseline|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
316951|NCT00255034|P2|Participant Flow|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
316952|NCT00255034|P1|Participant Flow|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
316953|NCT00255034|O2|Outcome|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
316959|NCT00255047|B3|Baseline|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
316960|NCT00255047|B2|Baseline|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316961|NCT00255047|B1|Baseline|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
316962|NCT00255047|P4|Participant Flow|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316963|NCT00255047|P3|Participant Flow|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
316964|NCT00255047|P2|Participant Flow|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316965|NCT00255047|P1|Participant Flow|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
316966|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316967|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
316968|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316969|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
316970|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316971|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
316972|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316973|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
316974|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316975|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
316976|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316977|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
316978|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316979|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
316980|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316981|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
316982|NCT00255047|E4|Reported Event|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316983|NCT00255047|E3|Reported Event|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
316984|NCT00255047|E2|Reported Event|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
316985|NCT00255047|E1|Reported Event|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
316986|NCT00255086|B3|Baseline|Total|Total of all reporting groups
316987|NCT00255086|B2|Baseline|Control|10mg Placebo pill
316988|NCT00255086|B1|Baseline|Memantine|"10mg Memantine
Memantine"
316989|NCT00255086|P2|Participant Flow|Control|Participants were given Placebo
316990|NCT00255086|P1|Participant Flow|Memantine|"10mg Memantine
Memantine"
316991|NCT00255086|O2|Outcome|Control|10mg Placebo pill
316992|NCT00255086|O1|Outcome|Memantine|"10mg Memantine
Memantine"
316993|NCT00255086|O2|Outcome|Control|Participants were given Placebo
316994|NCT00255086|O1|Outcome|Memantine|"10mg Memantine
Memantine"
316998|NCT00255125|B2|Baseline|Arm Soy Supplement|"Soy Supplement
Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
316999|NCT00255125|B1|Baseline|Arm Placebo|"Placebo
Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
317000|NCT00255125|P2|Participant Flow|Arm Soy Supplement|"Soy Supplement
Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
317001|NCT00255125|P1|Participant Flow|Arm Placebo|"Placebo
Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
317050|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317002|NCT00255125|O2|Outcome|Arm Soy Supplement|"Soy Supplement
Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
317003|NCT00255125|O1|Outcome|Arm Placebo|"Placebo
Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
317004|NCT00255125|E2|Reported Event|Arm Soy Supplement|"Soy Supplement
Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
317005|NCT00255125|E1|Reported Event|Arm Placebo|"Placebo
Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
317006|NCT00255151|B4|Baseline|Total|Total of all reporting groups
317007|NCT00255151|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317008|NCT00255151|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317009|NCT00255151|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317010|NCT00255151|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317011|NCT00255151|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317012|NCT00255151|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317013|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317014|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317015|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317016|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317017|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317018|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317019|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317020|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317021|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317022|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317023|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317024|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317025|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317026|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317027|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317028|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317029|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317030|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317031|NCT00255151|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317032|NCT00255151|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317033|NCT00255151|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317034|NCT00255164|B4|Baseline|Total|Total of all reporting groups
317035|NCT00255164|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317036|NCT00255164|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317037|NCT00255164|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317038|NCT00255164|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317339|NCT00257686|O5|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
317039|NCT00255164|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317040|NCT00255164|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317041|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317042|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317043|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317044|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317045|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317046|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317047|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317048|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317049|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317221|NCT00257309|B3|Baseline|Total|Total of all reporting groups
317051|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317052|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317053|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317054|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317055|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317056|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317057|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317058|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317059|NCT00255164|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
317060|NCT00255164|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
317061|NCT00255164|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
317062|NCT00255177|B5|Baseline|Total|Total of all reporting groups
317063|NCT00255177|B4|Baseline|VGX-410 300mg Twice Daily|
317064|NCT00255177|B3|Baseline|VGX-410 300mg Daily|
317065|NCT00255177|B2|Baseline|VGX-410 150mg Daily|
317066|NCT00255177|B1|Baseline|Placebo|
317067|NCT00255177|P4|Participant Flow|VGX-410 300mg Twice Daily|
317068|NCT00255177|P3|Participant Flow|VGX-410 300mg Daily|
317069|NCT00255177|P2|Participant Flow|VGX-410 150mg Daily|
317070|NCT00255177|P1|Participant Flow|Placebo|
317071|NCT00255177|O4|Outcome|VGX-410 300mg Twice Daily|
317072|NCT00255177|O3|Outcome|VGX-410 300mg Daily|
317073|NCT00255177|O2|Outcome|VGX-410 150mg Daily|
317074|NCT00255177|O1|Outcome|Placebo|
317075|NCT00255177|E4|Reported Event|VGX-410 300mg Twice Daily|
317076|NCT00255177|E3|Reported Event|VGX-410 300mg Daily|
317077|NCT00255177|E2|Reported Event|VGX-410 150mg Daily|
317078|NCT00255177|E1|Reported Event|Placebo|
317079|NCT00255190|B3|Baseline|Total|Total of all reporting groups
317080|NCT00255190|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317081|NCT00255190|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317082|NCT00255190|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317083|NCT00255190|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317084|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317085|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317086|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317087|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317088|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317089|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317090|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317091|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317092|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317093|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317094|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317095|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317096|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317097|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317098|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317099|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317100|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317101|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317102|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317103|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317104|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317105|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317106|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317107|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317108|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317109|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317110|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317111|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317112|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317113|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317114|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317115|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317116|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317117|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317118|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317119|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317120|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317121|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317122|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317123|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317124|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317125|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317126|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317127|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317128|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317129|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317130|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317131|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317132|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317133|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317134|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317135|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317136|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317137|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317138|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317139|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317140|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317141|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317142|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317143|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317144|NCT00255190|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
317145|NCT00255190|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
317146|NCT00255684|B1|Baseline|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
graft-versus-tumor prophylaxis therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy"
317147|NCT00255684|P1|Participant Flow|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
graft-versus-tumor prophylaxis therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy"
317148|NCT00255684|O1|Outcome|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
graft-versus-tumor prophylaxis therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy"
317182|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
317183|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
317340|NCT00257686|O4|Outcome|Pravastatin 20 mg|Pravastatin 20 mg once daily
317149|NCT00255684|O1|Outcome|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
graft-versus-tumor prophylaxis therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy"
317150|NCT00255684|E1|Reported Event|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
graft-versus-tumor prophylaxis therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy"
317151|NCT00255723|B3|Baseline|Total|Total of all reporting groups
317152|NCT00255723|B2|Baseline|Arm B|Augmented ICE x 2 cycles (2 risk factors)
317153|NCT00255723|B1|Baseline|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
317154|NCT00255723|P2|Participant Flow|Arm B|Augmented ICE x 2 cycles (2 risk factors)
317155|NCT00255723|P1|Participant Flow|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
317156|NCT00255723|O2|Outcome|Arm B|Augmented ICE x 2 cycles (2 risk factors)
317157|NCT00255723|O1|Outcome|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
317158|NCT00255723|E2|Reported Event|Arm B|Augmented ICE x 2 cycles (2 risk factors)
317159|NCT00255723|E1|Reported Event|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
317160|NCT00255840|B3|Baseline|Total|Total of all reporting groups
317222|NCT00257309|B2|Baseline|Primary Angioplasty|"Primary angioplasty
Primary angioplasty"
317161|NCT00255840|B2|Baseline|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:
Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
Lamivudine (150mg twice daily) and
Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
317162|NCT00255840|B1|Baseline|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:
Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
Lamivudine (150mg twice daily) and
Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
317163|NCT00255840|P2|Participant Flow|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:
Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
Lamivudine (150mg twice daily) and
Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
317164|NCT00255840|P1|Participant Flow|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:
Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
Lamivudine (150mg twice daily) and
Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
317165|NCT00255840|O2|Outcome|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:
Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
Lamivudine (150mg twice daily) and
Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
317166|NCT00255840|O1|Outcome|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:
Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
Lamivudine (150mg twice daily) and
Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
317167|NCT00255840|E2|Reported Event|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:
Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
Lamivudine (150mg twice daily) and
Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
317168|NCT00255840|E1|Reported Event|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:
Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
Lamivudine (150mg twice daily) and
Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
317169|NCT00255970|B3|Baseline|Total|Total of all reporting groups
317170|NCT00255970|B2|Baseline|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
317171|NCT00255970|B1|Baseline|Regenafil|Regenafil graft
317172|NCT00255970|P2|Participant Flow|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
317173|NCT00255970|P1|Participant Flow|Regenafil|Regenafil graft
317174|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
317175|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
317176|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
317177|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
317178|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
317179|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
317180|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
317181|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
317184|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
317185|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
317186|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
317187|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
317188|NCT00255970|E2|Reported Event|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
317189|NCT00255970|E1|Reported Event|Regenafil|Regenafil graft
317190|NCT00256204|B5|Baseline|Total|Total of all reporting groups
317191|NCT00256204|B4|Baseline|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
317192|NCT00256204|B3|Baseline|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
317193|NCT00256204|B2|Baseline|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
317194|NCT00256204|B1|Baseline|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
317195|NCT00256204|P4|Participant Flow|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
317196|NCT00256204|P3|Participant Flow|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
317356|NCT00257894|B3|Baseline|Total|Total of all reporting groups
317197|NCT00256204|P2|Participant Flow|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
317198|NCT00256204|P1|Participant Flow|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
317199|NCT00256204|O4|Outcome|2mg Delayed Start|+1mg Delayed Start: see 1st column
317200|NCT00256204|O3|Outcome|2mg Early Start|2mg early start active treatment arm (72 weeks active)
317201|NCT00256204|O2|Outcome|1mg Early Start|1mg early start active treatment arm (72 weeks active)
317202|NCT00256204|O1|Outcome|1mg Delayed Start|+ 2 mg Delayed Start: 36 week combined placebo group.
317203|NCT00256204|O4|Outcome|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
317204|NCT00256204|O3|Outcome|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
317205|NCT00256204|O2|Outcome|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
317206|NCT00256204|O1|Outcome|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
317207|NCT00256204|E3|Reported Event|2mg Active Treatment|2mg Active & 2mg Delayed. This group includes those patients who received 2mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 2mg Delayed start treatment arm (36 weeks active treatment)
317208|NCT00256204|E2|Reported Event|1mg Active Treatment|1mg Active & 1mg Delayed. This group includes those patients who received 1mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 1mg Delayed start treatment arm (36 weeks active treatment)
317209|NCT00256204|E1|Reported Event|Placebo Combined Group|1mg & 2mg combined placebo group includes those patients in 1mg Delayed start and the 2mg Delayed start arms who received placebo for the first 36 weeks.
317210|NCT00256243|B1|Baseline|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)
This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
317211|NCT00256243|P1|Participant Flow|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (day 2-6)
This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
317212|NCT00256243|O1|Outcome|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)
This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
317213|NCT00256243|O1|Outcome|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.
317214|NCT00256243|E1|Reported Event|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)
This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
317215|NCT00256295|B1|Baseline|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.
Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days
Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
317336|NCT00257686|P2|Participant Flow|Pravastatin 10 mg|Pravastatin 10 mg once daily
317216|NCT00256295|P1|Participant Flow|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.
Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days
Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
317217|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.
Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days
Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
317218|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.
Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days
Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
317219|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.
Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days
Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
317220|NCT00256295|E1|Reported Event|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.
Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days
Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
317223|NCT00257309|B1|Baseline|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin
Tenecteplase + UFH (+ clopidogrel, since 01/97)"
317224|NCT00257309|P2|Participant Flow|Primary Angioplasty|"Primary angioplasty
Primary angioplasty"
317225|NCT00257309|P1|Participant Flow|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin
Tenecteplase + UFH (+ clopidogrel, since 01/97)"
317226|NCT00257309|O2|Outcome|Primary Angioplasty|"Primary angioplasty
Primary angioplasty"
317227|NCT00257309|O1|Outcome|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin
Tenecteplase + UFH (+ clopidogrel, since 01/97)"
317228|NCT00257309|O2|Outcome|Primary Angioplasty|"Primary angioplasty
Primary angioplasty"
317229|NCT00257309|O1|Outcome|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin
Tenecteplase + UFH (+ clopidogrel, since 01/97)"
317230|NCT00257309|E2|Reported Event|Primary Angioplasty|"Primary angioplasty
Primary angioplasty"
317231|NCT00257309|E1|Reported Event|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin
Tenecteplase + UFH (+ clopidogrel, since 01/97)"
317232|NCT00257322|B1|Baseline|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
317233|NCT00257322|P1|Participant Flow|Chemo Therapy and GM-CSF|Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m^2 SQ QD with a cap of 500mcg SQ QD
317234|NCT00257322|O1|Outcome|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
317235|NCT00257322|O1|Outcome|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
317236|NCT00257322|E1|Reported Event|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
317237|NCT00257556|B3|Baseline|Total|Total of all reporting groups
317238|NCT00257556|B2|Baseline|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317239|NCT00257556|B1|Baseline|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317240|NCT00257556|P2|Participant Flow|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317241|NCT00257556|P1|Participant Flow|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317242|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317243|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317244|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317245|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317246|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317247|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317248|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317249|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317250|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317251|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317252|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317253|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317254|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317255|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317256|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317257|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317258|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317259|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317260|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317261|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317262|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317263|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317264|NCT00257556|E2|Reported Event|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
317265|NCT00257556|E1|Reported Event|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
317266|NCT00257608|B3|Baseline|Total|Total of all reporting groups
317267|NCT00257608|B2|Baseline|Bevacizumab + Erlotinib|Participants received Bevacizumab 15 mg/kg IV on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily
317268|NCT00257608|B1|Baseline|Bevacizumab + Placebo|Participants received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily
317269|NCT00257608|P3|Participant Flow|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
317270|NCT00257608|P2|Participant Flow|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
317299|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317271|NCT00257608|P1|Participant Flow|Bevacizumab + Chemotherapy|Participants received one of six chemotherapy regimens (Carboplatin + Paclitaxel or Carboplatin + Gemcitabine or Carboplatin + Docetaxel or Cisplatin + Gemcitabine or Cisplatin + Docetaxel / Cisplatin + vinorelbine) followed by Bevacizumab on Day 1 of each cycle up to 4 cycles.
317272|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
317273|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
317274|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
317275|NCT00257608|O1|Outcome|Bevacizumab + Placebo|"Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib.
orally daily."
317276|NCT00257608|O5|Outcome|Other|Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles.
317277|NCT00257608|O4|Outcome|Cisplatin + Gemcitabine|Participants received IV dose of Cisplatin 80 mg/m^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
317278|NCT00257608|O3|Outcome|Carboplatin + Docetaxel|Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
317279|NCT00257608|O2|Outcome|Carboplatin + Gemcitabine|Participants received IV dose of Carboplatin at a dose based on the AUC of 5 mg/mL × min on Day 1 of each 21-day cycle and Gemcitabine 1200 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
317280|NCT00257608|O1|Outcome|Carboplatin + Paclitaxel|Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
317281|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
317282|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
317283|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
317284|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
317285|NCT00257608|O5|Outcome|Other|Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles.
317286|NCT00257608|O4|Outcome|Cisplatin + Gemcitabine|Participants received IV dose of Cisplatin 80 mg/m^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
317287|NCT00257608|O3|Outcome|Carboplatin + Docetaxel|Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
317288|NCT00257608|O2|Outcome|Carboplatin + Gemcitabine|Participants received IV dose of Carboplatin at a dose based on the AUC of 5 mg/mL × min on Day 1 of each 21-day cycle and Gemcitabine 1200 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
317289|NCT00257608|O1|Outcome|Carboplatin + Paclitaxel|Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration-time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
317337|NCT00257686|P1|Participant Flow|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
317290|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
317291|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
317292|NCT00257608|E2|Reported Event|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
317293|NCT00257608|E1|Reported Event|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
317294|NCT00257660|B3|Baseline|Total|Total of all reporting groups
317295|NCT00257660|B2|Baseline|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317296|NCT00257660|B1|Baseline|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317297|NCT00257660|P2|Participant Flow|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317298|NCT00257660|P1|Participant Flow|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317300|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317301|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317302|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317303|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317304|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317305|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317306|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317307|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317308|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317309|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317310|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317311|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317312|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317313|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317314|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317315|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317316|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317317|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317318|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317319|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317320|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317321|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317322|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317323|NCT00257660|E2|Reported Event|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317324|NCT00257660|E1|Reported Event|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
317325|NCT00257686|B7|Baseline|Total|Total of all reporting groups
317326|NCT00257686|B6|Baseline|Pravastatin 40 mg|Pravastatin 40 mg once daily
317327|NCT00257686|B5|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
317328|NCT00257686|B4|Baseline|Pravastatin 20 mg|Pravastatin 20 mg once daily
317329|NCT00257686|B3|Baseline|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
317330|NCT00257686|B2|Baseline|Pravastatin 10 mg|Pravastatin 10 mg once daily
317331|NCT00257686|B1|Baseline|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
317332|NCT00257686|P6|Participant Flow|Pravastatin 40 mg|Pravastatin 40 mg once daily
317333|NCT00257686|P5|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
317334|NCT00257686|P4|Participant Flow|Pravastatin 20 mg|Pravastatin 20 mg once daily
317335|NCT00257686|P3|Participant Flow|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
317341|NCT00257686|O3|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
317342|NCT00257686|O2|Outcome|Pravastatin 10 mg|Pravastatin 10 mg once daily
317343|NCT00257686|O1|Outcome|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
317344|NCT00257686|O6|Outcome|Pravastatin 40 mg|Pravastatin 40 mg once daily
317345|NCT00257686|O5|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
317346|NCT00257686|O4|Outcome|Pravastatin 20 mg|Pravastatin 20 mg once daily
317347|NCT00257686|O3|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
317348|NCT00257686|O2|Outcome|Pravastatin 10 mg|Pravastatin 10 mg once daily
317349|NCT00257686|O1|Outcome|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
317350|NCT00257686|E6|Reported Event|Pravastatin 40 mg|Pravastatin 40 mg once daily
317351|NCT00257686|E5|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
317352|NCT00257686|E4|Reported Event|Pravastatin 20 mg|Pravastatin 20 mg once daily
317353|NCT00257686|E3|Reported Event|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
317354|NCT00257686|E2|Reported Event|Pravastatin 10 mg|Pravastatin 10 mg once daily
317357|NCT00257894|B2|Baseline|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
317358|NCT00257894|B1|Baseline|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
317359|NCT00257894|P2|Participant Flow|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
317360|NCT00257894|P1|Participant Flow|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
317361|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
317362|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
317363|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
317364|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
317365|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
317366|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
317367|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
317368|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
317369|NCT00257894|E2|Reported Event|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
317370|NCT00257894|E1|Reported Event|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
317371|NCT00257920|B3|Baseline|Total|Total of all reporting groups
317372|NCT00257920|B2|Baseline|Hectorol First|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
317373|NCT00257920|B1|Baseline|Zemplar First|6 mcg Zemplar Injection QOD for 6 doses in Period 1 and 3.6 mcg Hectorol Injection QOD for 6 doses in Period 2
317374|NCT00257920|P2|Participant Flow|Hectorol First|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
317375|NCT00257920|P1|Participant Flow|Zemplar First|6 mcg Zemplar Injection every other day (QOD) for 6 doses in Period 1 and 3.6 mcg Hectorol Injection for 6 doses in Period 2
317376|NCT00257920|O2|Outcome|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
317377|NCT00257920|O1|Outcome|Zemplar|6 mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2
317378|NCT00257920|O2|Outcome|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2.
317379|NCT00257920|O1|Outcome|Zemplar|6 mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2
317380|NCT00257920|E2|Reported Event|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
317381|NCT00257920|E1|Reported Event|Zemplar|6mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2.
317382|NCT00257933|B3|Baseline|Total|Total of all reporting groups
317383|NCT00257933|B2|Baseline|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
317384|NCT00257933|B1|Baseline|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
317385|NCT00257933|P2|Participant Flow|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
317386|NCT00257933|P1|Participant Flow|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
317387|NCT00257933|O2|Outcome|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
317388|NCT00257933|O1|Outcome|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
317389|NCT00257933|E2|Reported Event|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
317390|NCT00257933|E1|Reported Event|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
317391|NCT00258011|B1|Baseline|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
317392|NCT00258011|P1|Participant Flow|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
317393|NCT00258011|O1|Outcome|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
317394|NCT00258011|O1|Outcome|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
317395|NCT00258011|E1|Reported Event|Aldurazyme|Aldurazyme
317396|NCT00258154|B3|Baseline|Total|Total of all reporting groups
317397|NCT00258154|B2|Baseline|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317398|NCT00258154|B1|Baseline|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317399|NCT00258154|P2|Participant Flow|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317400|NCT00258154|P1|Participant Flow|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317401|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317402|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317403|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317404|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317405|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317406|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317407|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317408|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317409|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317410|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317411|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317412|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317413|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317414|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317415|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317416|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317417|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317418|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317419|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317420|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317421|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317422|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317423|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317424|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317425|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317426|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317427|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317428|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317429|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317430|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317431|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317432|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317433|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317434|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317435|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317436|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317437|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317438|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317439|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317440|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317441|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317442|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317443|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317444|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317445|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317446|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317447|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317448|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317449|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317450|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317451|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317452|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317453|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317454|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317455|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317456|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317457|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317458|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317459|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317460|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317461|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317462|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317463|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
318074|NCT00263211|O1|Outcome|Plavix and Aspirin|
317464|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317465|NCT00258154|E2|Reported Event|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
317466|NCT00258154|E1|Reported Event|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
317467|NCT00258206|B1|Baseline|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
317468|NCT00258206|P1|Participant Flow|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
317577|NCT00258830|B3|Baseline|Total|Total of all reporting groups
328567|NCT00296374|E2|Reported Event|Rosuvastatin 40mg|
317469|NCT00258206|O1|Outcome|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
317470|NCT00258206|E1|Reported Event|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
317471|NCT00258310|B1|Baseline|Capecitabine|"Capecitabine 1000mg/day for one year
capecitabine
adjuvant therapy"
317472|NCT00258310|P1|Participant Flow|Capecitabine|"Capecitabine 1000mg/day for one year
capecitabine
adjuvant therapy"
317473|NCT00258310|O1|Outcome|Capecitabine|"Capecitabine 1000mg/day for one year
capecitabine
adjuvant therapy"
317474|NCT00258310|E1|Reported Event|Capcitabine|"Caoecutabube 1000mg/day for one year
capecitabine
adjuvant therapy"
317475|NCT00258349|B1|Baseline|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.
317476|NCT00258349|P1|Participant Flow|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.
317477|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
317478|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
317479|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|"Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks;
Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle"
317480|NCT00258349|E2|Reported Event|Vorinostat +Trastuzumab (Phase I)|phase I patients for identify maximum tolerated dose
317481|NCT00258349|E1|Reported Event|Vorinostat +Trastuzumab (Phase II)|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
317482|NCT00258362|B1|Baseline|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. This group excludes those patients with recurrent endometrial cancer.
317483|NCT00258362|P1|Participant Flow|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
317484|NCT00258362|O1|Outcome|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
317485|NCT00258362|O1|Outcome|Patients With Endometrial Cancer|Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
317486|NCT00258362|E1|Reported Event|Patients With Endometrial Cancer|Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
317487|NCT00258440|B4|Baseline|Total|Total of all reporting groups
317488|NCT00258440|B3|Baseline|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
317489|NCT00258440|B2|Baseline|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
317490|NCT00258440|B1|Baseline|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
317491|NCT00258440|P3|Participant Flow|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
317492|NCT00258440|P2|Participant Flow|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
317493|NCT00258440|P1|Participant Flow|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
317494|NCT00258440|O3|Outcome|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
317495|NCT00258440|O2|Outcome|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
317496|NCT00258440|O1|Outcome|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
317497|NCT00258440|O3|Outcome|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
317498|NCT00258440|O2|Outcome|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
317499|NCT00258440|O1|Outcome|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
317500|NCT00258440|E3|Reported Event|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
317501|NCT00258440|E2|Reported Event|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
317502|NCT00258440|E1|Reported Event|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
317503|NCT00258674|B4|Baseline|Total|Total of all reporting groups
317504|NCT00258674|B3|Baseline|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317505|NCT00258674|B2|Baseline|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317506|NCT00258674|B1|Baseline|Claims|Physician feedback of patient process measures using Medicare claims data
317507|NCT00258674|P3|Participant Flow|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317508|NCT00258674|P2|Participant Flow|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317509|NCT00258674|P1|Participant Flow|Claims|Physician feedback of patient process measures using Medicare claims data
317510|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317511|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317512|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317513|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317514|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317515|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317516|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317517|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317518|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317519|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317520|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317521|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317522|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317523|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317524|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317525|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317526|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317527|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317528|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
318075|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
317529|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317530|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317531|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317532|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317533|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317534|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317535|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317536|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317578|NCT00258830|B2|Baseline|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317537|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317538|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317539|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317540|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317541|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317542|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317543|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317544|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317545|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317546|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317547|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317548|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317549|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317550|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317551|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317552|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317553|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317554|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317555|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317556|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317557|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317558|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317559|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317560|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
317561|NCT00258674|E3|Reported Event|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
317562|NCT00258674|E2|Reported Event|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
317563|NCT00258674|E1|Reported Event|Claims|Physician feedback of patient process measures using Medicare claims data
317564|NCT00258817|B3|Baseline|Total|Total of all reporting groups
317565|NCT00258817|B2|Baseline|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
317566|NCT00258817|B1|Baseline|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
317567|NCT00258817|P2|Participant Flow|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
317568|NCT00258817|P1|Participant Flow|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
318767|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
317569|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
317570|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
317571|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
317572|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
317573|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
317574|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
317575|NCT00258817|E2|Reported Event|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
317576|NCT00258817|E1|Reported Event|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
317579|NCT00258830|B1|Baseline|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317580|NCT00258830|P2|Participant Flow|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317581|NCT00258830|P1|Participant Flow|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317582|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317583|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317584|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317585|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317586|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317587|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317588|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317589|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317590|NCT00258830|E2|Reported Event|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317591|NCT00258830|E1|Reported Event|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
317592|NCT00258856|B5|Baseline|Total|Total of all reporting groups
317593|NCT00258856|B4|Baseline|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
317594|NCT00258856|B3|Baseline|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
317595|NCT00258856|B2|Baseline|Menactra® Group 2|"Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
317596|NCT00258856|B1|Baseline|Menactra® Group 1|"Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
317597|NCT00258856|P4|Participant Flow|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.
317598|NCT00258856|P3|Participant Flow|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
317599|NCT00258856|P2|Participant Flow|Menactra® Group 2|"Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
317600|NCT00258856|P1|Participant Flow|Menactra® Group 1|"Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
317601|NCT00258856|O4|Outcome|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
317602|NCT00258856|O3|Outcome|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
317603|NCT00258856|O2|Outcome|Menactra® Group 2|"Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
317604|NCT00258856|O1|Outcome|Menactra® Group 1|"Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
317605|NCT00258856|E4|Reported Event|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
317606|NCT00258856|E3|Reported Event|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
317640|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
317607|NCT00258856|E2|Reported Event|Menactra® Group 2|"Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
317608|NCT00258856|E1|Reported Event|Menactra® Group 1|"Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
317609|NCT00258882|B3|Baseline|Total|Total of all reporting groups
317610|NCT00258882|B2|Baseline|Control Groups|Non-pregnant individuals matched by age to individuals who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier.
317611|NCT00258882|B1|Baseline|Adacel Vaccine Group|"Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination.
Each non-pregnant recipient served as their own control for evaluation of acute events. Rates of events occurring during Day 0 to 60 following vaccination were compared to rates of events occurring during Day 61 to 120 following vaccination (Short-term surveillance)"
317612|NCT00258882|P2|Participant Flow|Control Groups|For each pregnant individual receiving Adacel vaccine, 3 control individuals not given Adacel vaccine were matched on age and month of their first positive pregnancy test. For non-pregnant individuals, age-matched individuals were identified who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier.
317613|NCT00258882|P1|Participant Flow|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination.
317614|NCT00258882|O2|Outcome|Control Groups|Age matched pregnant controls who did not receive Adacel vaccine.
317615|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period and were pregnant at the time of vaccination or became pregnant within 28 days after vaccination
317616|NCT00258882|O2|Outcome|Control Groups|Age matched pregnant controls who did not receive Adacel vaccine.
317617|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period and were pregnant at the time of vaccination or became pregnant within 28 days after vaccination.
317618|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
317619|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
317620|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
317621|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
317622|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
317623|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
317624|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
317625|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
317626|NCT00258882|E1|Reported Event|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period. They are sub-grouped as those pregnant at the time of vaccination with Adacel or who became pregnant within 28 days after vaccination and other recipients are classified by age at vaccination.
317627|NCT00258895|B3|Baseline|Total|Total of all reporting groups
317628|NCT00258895|B2|Baseline|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
317629|NCT00258895|B1|Baseline|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
317630|NCT00258895|P2|Participant Flow|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
317631|NCT00258895|P1|Participant Flow|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
317632|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
317633|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
317634|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
317635|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
317636|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
317637|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
317638|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
317639|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
317641|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
317642|NCT00258895|E2|Reported Event|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
317643|NCT00258895|E1|Reported Event|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
317644|NCT00258908|B1|Baseline|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
317645|NCT00258908|P1|Participant Flow|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
317646|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
317647|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
317648|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
317649|NCT00258908|E1|Reported Event|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
317650|NCT00259012|B3|Baseline|Total|Total of all reporting groups
318040|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
317651|NCT00259012|B2|Baseline|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317652|NCT00259012|B1|Baseline|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317653|NCT00259012|P2|Participant Flow|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317654|NCT00259012|P1|Participant Flow|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317655|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317656|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317657|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317658|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317659|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317660|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317661|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317662|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317663|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317664|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317665|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317666|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317667|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317668|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317669|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317670|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317671|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317708|NCT00259272|B1|Baseline|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
318083|NCT00263211|E2|Reported Event|Observation Only|Observation by treating physician
317672|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317673|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317674|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317675|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317676|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317677|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317678|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317679|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317680|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317681|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317682|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317683|NCT00259012|E2|Reported Event|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
317684|NCT00259012|E1|Reported Event|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
317685|NCT00259090|B4|Baseline|Total|Total of all reporting groups
317686|NCT00259090|B3|Baseline|Anastrozole|Anastrozole 1 mg once daily tablet
317687|NCT00259090|B2|Baseline|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
317688|NCT00259090|B1|Baseline|Fulvestrant|Fulvestrant 500 mg once monthly injection
317689|NCT00259090|P3|Participant Flow|Anastrozole|Anastrozole 1 mg once daily tablet
317690|NCT00259090|P2|Participant Flow|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
317691|NCT00259090|P1|Participant Flow|Fulvestrant|Fulvestrant 500 mg once monthly injection
317692|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
317693|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
317694|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
317695|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
319211|NCT00265395|E1|Reported Event|Standard Therapy (48-week Treatment)|
317696|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
317697|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
317698|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
317699|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
317700|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
317701|NCT00259090|E3|Reported Event|Anastrozole|Anastrozole 1 mg once daily tablet
317702|NCT00259090|E2|Reported Event|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
317703|NCT00259090|E1|Reported Event|Fulvestrant|Fulvestrant 500 mg once monthly injection
317704|NCT00259272|B5|Baseline|Total|Total of all reporting groups
317705|NCT00259272|B4|Baseline|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317706|NCT00259272|B3|Baseline|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317707|NCT00259272|B2|Baseline|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
318328|NCT00264004|P3|Participant Flow|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
317709|NCT00259272|P4|Participant Flow|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317710|NCT00259272|P3|Participant Flow|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317711|NCT00259272|P2|Participant Flow|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317712|NCT00259272|P1|Participant Flow|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317713|NCT00259272|O3|Outcome|Cumulative|
317714|NCT00259272|O2|Outcome|Proportion|
317715|NCT00259272|O1|Outcome|Eigen Value|
317716|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317717|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317718|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317719|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317720|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317721|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317722|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317723|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317724|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317725|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317726|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317727|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317728|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317729|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317730|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317731|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317732|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
317733|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
317734|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
317735|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
317736|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
317737|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
317738|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
317739|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
317740|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
317741|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
317742|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
317743|NCT00259272|O1|Outcome|Thymic Hypo-Reactive|As assessed by the investigator according to his clinical experience.
317744|NCT00259272|O1|Outcome|Weight Gain Subgroup|Patients who gained more than 7% of body weight during the study.
317745|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317746|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317747|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317748|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317749|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317750|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317751|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317752|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317753|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317754|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317755|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317756|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317757|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317758|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317759|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317760|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317761|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317762|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317763|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317764|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317765|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317766|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317767|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317768|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317769|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317770|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317771|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317772|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317773|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317774|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317775|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317776|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317777|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317778|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317779|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317780|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317781|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
317782|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317783|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
317784|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
317785|NCT00259272|E1|Reported Event|Olanzapine|Olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
317786|NCT00259285|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
317787|NCT00259285|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
317788|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
317789|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
317790|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
317791|NCT00259285|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
317792|NCT00259298|B1|Baseline|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
328568|NCT00296374|E1|Reported Event|Rosuvastatin 10mg|
317793|NCT00259298|P1|Participant Flow|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
317794|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
317795|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
317796|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
317797|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
317798|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
317799|NCT00259298|E1|Reported Event|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
317800|NCT00259610|B5|Baseline|Total|Total of all reporting groups
317801|NCT00259610|B4|Baseline|MTX + Placebo SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
317802|NCT00259610|B3|Baseline|MTX + Placebo Entaneracept|methotrexate (MTX) or MTX + Etanercept
317803|NCT00259610|B2|Baseline|MTX+ Active SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
317804|NCT00259610|B1|Baseline|MTX + Active Etanercept|Methotrexate (MTX) + etanercept
317805|NCT00259610|P4|Participant Flow|MTX + Placebo SSZ + HCQ(ST)|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth
317806|NCT00259610|P3|Participant Flow|MTX + Placebo Entaneracept|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + Etanercept(Placebo) 50mg/qw by injection
317807|NCT00259610|P2|Participant Flow|MTX+ Active SSZ +HCQ|methotrexate (MTX)20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth
317808|NCT00259610|P1|Participant Flow|MTX + Active Etanercept|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + etanercept 50mg/qw by injection
317809|NCT00259610|O4|Outcome|MTX + Step-up SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
317810|NCT00259610|O3|Outcome|MTX + Step-up Etanercept|methotrexate (MTX) or MTX + Etanercept
317811|NCT00259610|O2|Outcome|MTX+ Immediate SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
317812|NCT00259610|O1|Outcome|MTX + Immediate Etanercept|Methotrexate (MTX) + etanercept
317813|NCT00259610|O4|Outcome|MTX + Step-up SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
317814|NCT00259610|O3|Outcome|MTX + Step-up Etanercept|methotrexate (MTX) or MTX + Etanercept
317815|NCT00259610|O2|Outcome|MTX+ Immediate SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
317816|NCT00259610|O1|Outcome|MTX + Immediate Etanercept|Methotrexate (MTX) + etanercept
317817|NCT00259610|E4|Reported Event|MTX + Placebo SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
317818|NCT00259610|E3|Reported Event|MTX + Placebo Entaneracept|methotrexate (MTX) or MTX + Etanercept
317819|NCT00259610|E2|Reported Event|MTX+ Active SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
317820|NCT00259610|E1|Reported Event|MTX + Active Etanercept|Methotrexate (MTX) + etanercept
317821|NCT00259649|B1|Baseline|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
317822|NCT00259649|P1|Participant Flow|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
317823|NCT00259649|O1|Outcome|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
317824|NCT00259649|E1|Reported Event|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
317825|NCT00259740|B3|Baseline|Total|Total of all reporting groups
317826|NCT00259740|B2|Baseline|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
317857|NCT00253435|E2|Reported Event|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
317827|NCT00259740|B1|Baseline|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
317828|NCT00259740|P2|Participant Flow|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
317829|NCT00259740|P1|Participant Flow|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
317830|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
317831|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
317832|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
317833|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
317834|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
317835|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
317836|NCT00259740|E2|Reported Event|Denosumab 120 mg Q4W - Plateau-Phase|
317837|NCT00259740|E1|Reported Event|Denosumab 120 mg Q4W - Relapsed|
317838|NCT00253370|B1|Baseline|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV"
317839|NCT00253370|P1|Participant Flow|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 400 mg twice daily on days 1-21. Patients also receive docetaxel IV, 75mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV"
317840|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV"
317841|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV"
317842|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV"
317843|NCT00253370|E1|Reported Event|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV"
317844|NCT00253435|B3|Baseline|Total|Total of all reporting groups
317845|NCT00253435|B2|Baseline|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
317846|NCT00253435|B1|Baseline|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
317847|NCT00253435|P2|Participant Flow|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
317848|NCT00253435|P1|Participant Flow|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
317849|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
317850|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
317851|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
317852|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
317853|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
317854|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
317855|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
317856|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
317858|NCT00253435|E1|Reported Event|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
317859|NCT00253448|B1|Baseline|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
317860|NCT00253448|P1|Participant Flow|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
317861|NCT00253448|O1|Outcome|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
317862|NCT00253448|E1|Reported Event|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
317863|NCT00253513|B1|Baseline|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
317864|NCT00253513|P1|Participant Flow|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
317865|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
317866|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
317867|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
317868|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
317869|NCT00253513|E1|Reported Event|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
317870|NCT00253643|B5|Baseline|Total|Total of all reporting groups
317871|NCT00253643|B4|Baseline|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day
placebo: Given olive oil placebo orally 3 times/day
placebo: Given green tea placebo orally 2 times/day"
317872|NCT00253643|B3|Baseline|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day
fish oil: Given orally 3 times/day
placebo: Given green tea placebo orally 2 times/day"
317873|NCT00253643|B2|Baseline|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day
green tea catechin extract: Given orally 2 times/day
placebo: Given olive oil placebo orally 3 times/day"
317874|NCT00253643|B1|Baseline|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day
green tea catechin extract: Given orally 2 times/day
fish oil: Given orally 3 times/day"
317875|NCT00253643|P4|Participant Flow|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day
placebo: Given olive oil placebo orally 3 times/day
placebo: Given green tea placebo orally 2 times/day
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies"
317876|NCT00253643|P3|Participant Flow|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day
fish oil: Given orally 3 times/day
placebo: Given green tea placebo orally 2 times/day
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies"
317877|NCT00253643|P2|Participant Flow|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day
green tea catechin extract: Given orally 2 times/day
placebo: Given olive oil placebo orally 3 times/day
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies"
317878|NCT00253643|P1|Participant Flow|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day
green tea catechin extract: Given orally 2 times/day
fish oil: Given orally 3 times/day
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies"
317879|NCT00253643|O4|Outcome|Arm IV|Fish oil placebo, Green Tea placebo
317880|NCT00253643|O3|Outcome|Arm III|Fish oil, Green Tea placebo
317881|NCT00253643|O2|Outcome|Arm II|Fish oil placebo, Green Tea catechin extract
317882|NCT00253643|O1|Outcome|Arm I|Fish oil, Green Tea catechin extract
317883|NCT00253643|O4|Outcome|Arm IV|Fish oil placebo, Green Tea placebo
317884|NCT00253643|O3|Outcome|Arm III|Fish oil, Green Tea placebo
317885|NCT00253643|O2|Outcome|Arm II|Fish oil placebo, Green Tea catechin extract
317886|NCT00253643|O1|Outcome|Arm I|Fish oil, Green Tea catechin extract
317887|NCT00253643|E4|Reported Event|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day
placebo: Given olive oil placebo orally 3 times/day
placebo: Given green tea placebo orally 2 times/day"
317888|NCT00253643|E3|Reported Event|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day
fish oil: Given orally 3 times/day
placebo: Given green tea placebo orally 2 times/day"
318390|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
317889|NCT00253643|E2|Reported Event|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day
green tea catechin extract: Given orally 2 times/day
placebo: Given olive oil placebo orally 3 times/day"
317890|NCT00253643|E1|Reported Event|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day
green tea catechin extract: Given orally 2 times/day
fish oil: Given orally 3 times/day"
317891|NCT00253708|B4|Baseline|Total|Total of all reporting groups
317892|NCT00253708|B3|Baseline|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
317893|NCT00253708|B2|Baseline|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317894|NCT00253708|B1|Baseline|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.
Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
318041|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
317895|NCT00253708|P3|Participant Flow|Usual Care (Control)|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
317896|NCT00253708|P2|Participant Flow|No Touch Intervention (Control)|The authors wanted to separate out the effect of interacting with a massage therapist from massage itself, so the therapists performed no-touch control interventions, which had no healing intention. Although most of the therapists had experience with energy healing, the therapists were trained to avoid ‘‘healing intention’’ in the no-touch group by using distraction if necessary, created by counting backwards. For the no-touch control intervention, therapists were instructed to be with the patients between 15 and 45 minutes, depending on the patient’s tolerance, and to hold their hands about 12 inches over the patient’s body. In the usual-care control group, patients completed the same questionnaires but did not receive any visits from the massage therapists.
317897|NCT00253708|P1|Participant Flow|Touch Intervention (Massage Therapy)|Patients received three visits by the professional massage therapists over the first week after the enrollment. Massage treatments were scheduled based on patient preferences, and the duration was between 15 and 45 minutes; both the duration and the amount of pressure was modified depending on patient comfort. A limited scope of practice was provided to the massage therapists that specified the allowed and disallowed massage modalities and techniques. Allowed techniques were both Swedish and non-Swedish massage including gliding/effleurage, gentle kneading/petrissage, compression, gentle stretching, rocking, light myofascial release, active and/or passive range of motion, warm or cool applications, and use of acupressure points as well as craniosacral holds thought to have calming and centering effects. No forms of friction, deep-tissue massage, or bodywork forms that required movement by the patients were allowed.
317898|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
317899|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317900|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.
Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317901|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
317902|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317903|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.
Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317904|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
317905|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317906|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.
Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317907|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
317908|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317909|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.
Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317910|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
317911|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317935|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
318042|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
317912|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.
Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317913|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
317914|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317915|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.
Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317916|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
317917|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317918|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.
Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317919|NCT00253708|E3|Reported Event|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
317920|NCT00253708|E2|Reported Event|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317921|NCT00253708|E1|Reported Event|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.
Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
management of therapy complications
massage therapy
pain therapy
psychosocial assessment and care
quality-of-life assessment"
317922|NCT00259857|B3|Baseline|Total|Total of all reporting groups
317923|NCT00259857|B2|Baseline|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
317924|NCT00259857|B1|Baseline|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
317925|NCT00259857|P2|Participant Flow|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
317926|NCT00259857|P1|Participant Flow|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
317927|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
318250|NCT00263666|P1|Participant Flow|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
317928|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
317929|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
317930|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
317931|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
317932|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
317933|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
317934|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
328569|NCT00296400|B4|Baseline|Total|Total of all reporting groups
317936|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
317937|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
317938|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
317939|NCT00259857|E2|Reported Event|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
317940|NCT00259857|E1|Reported Event|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
317941|NCT00260065|B1|Baseline|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
317942|NCT00260065|P1|Participant Flow|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
317943|NCT00260065|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
317944|NCT00260065|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
317945|NCT00260065|E1|Reported Event|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
317946|NCT00262730|B1|Baseline|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy
poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)
temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)
radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
317947|NCT00262730|P1|Participant Flow|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy
poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)
temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)
radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
317948|NCT00262730|O1|Outcome|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy
poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)
temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)
radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
317949|NCT00262730|E1|Reported Event|Treatment Arm All Subjects|"poly ICLC, TMZ, RT: poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles) TMX : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant) RT : RT: 60 Gy (6 weeks) concomitant therapy
AEs Grades 4 with Attributions of Possible, probably or definitely related to TMZ AND poly-ICLI"
317950|NCT00262743|B3|Baseline|Total|Total of all reporting groups
317951|NCT00262743|B2|Baseline|Phase II Polyphenon E|2000mg twice daily for 6 months
317952|NCT00262743|B1|Baseline|Phase I Polyphenon E|Dose ranging from 400 to 1,800 mg orally twice daily for 6 months
317953|NCT00262743|P2|Participant Flow|Phase II Polyphenon E|2000mg orally twice daily for 6 months
317954|NCT00262743|P1|Participant Flow|Phase I Polyphenon E|Dose ranging from 400 to 1,800 mg orally twice a day for 6 months
317955|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
317956|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
317957|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
317958|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
317959|NCT00262743|E1|Reported Event|Phase II Polyphenon E|2000mg orally twice daily for 6 months
317960|NCT00262821|B3|Baseline|Total|Total of all reporting groups
317961|NCT00262821|B2|Baseline|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
318251|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
317962|NCT00262821|B1|Baseline|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
317963|NCT00262821|P2|Participant Flow|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
317964|NCT00262821|P1|Participant Flow|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
317965|NCT00262821|O2|Outcome|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
317966|NCT00262821|O1|Outcome|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
317967|NCT00262821|O2|Outcome|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
317968|NCT00262821|O1|Outcome|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
317969|NCT00262821|O2|Outcome|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
317970|NCT00262821|O1|Outcome|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
317971|NCT00262821|E2|Reported Event|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
317972|NCT00262821|E1|Reported Event|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
317973|NCT00262834|B3|Baseline|Total|Total of all reporting groups
317974|NCT00262834|B2|Baseline|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
317975|NCT00262834|B1|Baseline|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
317976|NCT00262834|P2|Participant Flow|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
317977|NCT00262834|P1|Participant Flow|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
317978|NCT00262834|O2|Outcome|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
317979|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
317980|NCT00262834|O2|Outcome|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
317981|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
317982|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
317983|NCT00262834|E1|Reported Event|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
317984|NCT00262847|B4|Baseline|Total|Total of all reporting groups
317985|NCT00262847|B3|Baseline|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
317986|NCT00262847|B2|Baseline|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
317987|NCT00262847|B1|Baseline|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
317988|NCT00262847|P3|Participant Flow|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
317989|NCT00262847|P2|Participant Flow|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
317990|NCT00262847|P1|Participant Flow|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
317991|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
317992|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
317993|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
317994|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
317995|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
317996|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
317997|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
317998|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
317999|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
318000|NCT00262847|E3|Reported Event|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
318001|NCT00262847|E2|Reported Event|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
318002|NCT00262847|E1|Reported Event|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks."
318003|NCT00262860|B1|Baseline|Bortezomib, Gemcitabine Hydrochloride|"bortezomib
gemcitabine hydrochloride
Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
318004|NCT00262860|P1|Participant Flow|Bortezomib, Gemcitabine Hydrochloride|"bortezomib
gemcitabine hydrochloride
Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
318005|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib
gemcitabine hydrochloride
Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
318006|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib
gemcitabine hydrochloride
Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
318007|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib
gemcitabine hydrochloride
Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
318008|NCT00262860|E1|Reported Event|Bortezomib, Gemcitabine Hydrochloride|"bortezomib
gemcitabine hydrochloride
Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
318009|NCT00262873|B1|Baseline|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
318010|NCT00262873|P1|Participant Flow|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
318011|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
318012|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
318013|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
318014|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
318015|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
318016|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
318017|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
318018|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
318019|NCT00262873|E1|Reported Event|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
318020|NCT00262925|B1|Baseline|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
318037|NCT00262964|P1|Participant Flow|NAFLD - Niacin|subjects diagnosed with NAFLD were randomized to a sixteen week regimen of niacin.
318038|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin.
318039|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with elevated intrahepatic triglyceride given an eight week course of fenofibrate
318021|NCT00262925|P1|Participant Flow|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
318022|NCT00262925|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"Detailed Description Section
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
alemtuzumab: Given subcutaneously
asparaginase: Given IM
methotrexate: Given IV or orally
dexamethasone: Given orally
leucovorin calcium: Given IV
mercaptopurine tablet: Given orally
vincristine sulfate: Given IV
laboratory biomarker analysis: Correlative studies"
318023|NCT00262925|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
318024|NCT00262925|E2|Reported Event|MOAD+Campath-Step 2|"Campath 10 mg dose
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
318025|NCT00262925|E1|Reported Event|MOAD+Campath-Step 1|"Campath 5mg dose
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
318026|NCT00262951|B1|Baseline|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
318027|NCT00262951|P1|Participant Flow|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
318028|NCT00262951|O1|Outcome|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients will be given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
318072|NCT00263211|O1|Outcome|Plavix and Aspirin|"Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
Plavix"
318029|NCT00262951|O1|Outcome|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients will be given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
318030|NCT00262951|E1|Reported Event|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
318031|NCT00262964|B3|Baseline|Total|Total of all reporting groups
318032|NCT00262964|B2|Baseline|NAFLD|Subjects diagnosed with Non-Alcoholic Fatty Liver Disease(NAFLD). Determination of NAFLD was by magnetic resonance spectroscopy of intra-hepatic triglyceride content (defined by greater than 10% lipid to water signal). This group included subjects later randomized into the NAFLD-Niacin, NAFLD-Fenofibrate, and NAFLD-no intervention arms.
318033|NCT00262964|B1|Baseline|Controls|Subjects with normal intra-hepatic triglyceride content (defined by less than 10% lipid to water signal in magnetic resonance spectroscopy).
318034|NCT00262964|P4|Participant Flow|NAFLD - no Drug|Subjects with elevated intrahepatic triglyceride (IHTG) levels (>10%) who were measured only once (baseline). These subjects did not undergo drug therapy, in contrast to the NAFLD-niacin and NAFLD-fenofibrate group subjects. IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0.
318035|NCT00262964|P3|Participant Flow|Controls|Subjects with normal intrahepatic fat triglyceride(IHTG) levels (<10%). IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0.
318036|NCT00262964|P2|Participant Flow|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
328570|NCT00296400|B3|Baseline|Atorvastatin 80 mg|
318043|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
318044|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given Niacin for 16 weeks
318045|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
318046|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride (>10% signal by MR spectroscopy) given a 16 week course of niacin
318047|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy receiving fenofibrate for eight weeks.
318048|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin
318049|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy given an eight week course of fenofibrate
318050|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given Niacin for 16 weeks
318051|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
318052|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
318053|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
318054|NCT00262964|O2|Outcome|Controls|subjects with normal intrahepatic triglyceride levels
318055|NCT00262964|O1|Outcome|NAFLD|Subjects with elevated intrahepatic triglyceride (>10% signal compared to H2O) measured by MR Spectroscopy.
318056|NCT00262964|O2|Outcome|Controls|subjects with normal levels of intra-hepatic trigleceride
318057|NCT00262964|O1|Outcome|NAFLD|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy
318058|NCT00262964|O2|Outcome|Controls|subjects with normal levels of intra-hepatic trigleceride
318059|NCT00262964|O1|Outcome|NAFLD|Subjects with intrahepatic triglyceride content greater than 10% per Magnetic Resonance Spectroscopy
318060|NCT00262964|O2|Outcome|Controls|subjects with normal intra-hepatic triglyceride levels
318061|NCT00262964|O1|Outcome|NAFLD|subjects with intra-hepatic triglyceride content greater than 10%.
318062|NCT00262964|E4|Reported Event|Controls|subjects with normal hepatic triglyceride.
318063|NCT00262964|E3|Reported Event|NAFLD - no Drug|subjects with elevated hepatic triglyceride who did not receive any drug intervention
318064|NCT00262964|E2|Reported Event|NAFLD - Niacin|subjects with intra-hepatic triglyceride signal greater than 10% placed on daily niacin for 16 weeks. The dose of medication will be gradually increased according to the protocol of most clinical trials (59): 500 mg/day during wk 1, 1000 mg/day during wk 2, 1500 mg/day during wks 3, and 2000mg/day during wks 4-16.
318065|NCT00262964|E1|Reported Event|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an weight week regimen of fenofibrate
318066|NCT00263211|B3|Baseline|Total|Total of all reporting groups
318067|NCT00263211|B2|Baseline|Observation Only|Observation by treating physician
318068|NCT00263211|B1|Baseline|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
318069|NCT00263211|P2|Participant Flow|Observation Only|Observation by treating physician
318070|NCT00263211|P1|Participant Flow|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
318071|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
318076|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
318077|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
318078|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
318079|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
318080|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
318081|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
318082|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
318084|NCT00263211|E1|Reported Event|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
318085|NCT00263328|B4|Baseline|Total|Total of all reporting groups
318086|NCT00263328|B3|Baseline|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318087|NCT00263328|B2|Baseline|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318088|NCT00263328|B1|Baseline|Tofacitinib|Participants received tacrolimus BID, administered according to standard institutional practice. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318089|NCT00263328|P3|Participant Flow|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318090|NCT00263328|P2|Participant Flow|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318091|NCT00263328|P1|Participant Flow|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months posttransplant. Thereafter, steroids may have been discontinued at the investigator’s discretion.
318252|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318253|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318092|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318093|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318094|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318329|NCT00264004|P2|Participant Flow|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
318330|NCT00264004|P1|Participant Flow|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
318095|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318096|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318097|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318098|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318099|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318100|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318254|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318255|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318256|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318101|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318102|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318103|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318104|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318105|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318106|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318107|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318108|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318109|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318110|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318111|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318112|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318113|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318114|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318331|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
318115|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator’s discretion.
318116|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318117|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318118|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318119|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318257|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318258|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318259|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318260|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318120|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318121|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318122|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318123|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318332|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
318333|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
318334|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
318335|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
318336|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
318124|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318125|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318126|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318127|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318128|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318261|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
321616|NCT00274469|P2|Participant Flow|Anastrozole 1 mg|Anastrozole 1 mg
318129|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318130|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318131|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318132|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318133|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318337|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
318134|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318135|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318136|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318137|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318262|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318263|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318264|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318265|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318138|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318139|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318140|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318141|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318142|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318143|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318144|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318145|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318146|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318266|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318267|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318268|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318269|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
321620|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
318147|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318148|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318149|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318150|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318151|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318152|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318171|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318153|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318154|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318155|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318156|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318157|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318158|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318159|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318160|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318161|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318280|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318281|NCT00263666|O1|Outcome|Rotarix Group 1|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318282|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318283|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
328571|NCT00296400|B2|Baseline|Rosuvastatin 40 mg|
318162|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318163|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318164|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318165|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318166|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318167|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318168|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318169|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318170|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318284|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318285|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318286|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318172|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318173|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318174|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318175|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318176|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318177|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318178|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318179|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318180|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318287|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318288|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318289|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318290|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
328572|NCT00296400|B1|Baseline|Rosuvastatin 10 mg|
318181|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318182|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318183|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318184|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318185|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318186|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318187|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318188|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318189|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318291|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318292|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318293|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318294|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
328573|NCT00296400|P3|Participant Flow|Atorvastatin 80 mg|
318190|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318191|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318192|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318193|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318194|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318195|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318196|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318197|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318198|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318295|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318296|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318297|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318298|NCT00263666|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
328574|NCT00296400|P2|Participant Flow|Rosuvastatin 40 mg|
318199|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318200|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318201|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318202|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318203|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318204|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318205|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318206|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318207|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318299|NCT00263666|E1|Reported Event|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318300|NCT00263757|B3|Baseline|Total|Total of all reporting groups
318301|NCT00263757|B2|Baseline|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
318302|NCT00263757|B1|Baseline|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
318303|NCT00263757|P2|Participant Flow|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
318208|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318209|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318210|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318211|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318212|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318213|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318214|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318215|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318216|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318304|NCT00263757|P1|Participant Flow|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
318305|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
318306|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
318307|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
328575|NCT00296400|P1|Participant Flow|Rosuvastatin 10 mg|
318217|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318218|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318219|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318220|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318221|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318222|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318223|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318224|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318225|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318308|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
318309|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
318310|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
318311|NCT00263757|E2|Reported Event|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
328576|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
318226|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318227|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318228|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318229|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318230|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318231|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318232|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318233|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318234|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318312|NCT00263757|E1|Reported Event|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
318313|NCT00263887|B3|Baseline|Total|Total of all reporting groups
318314|NCT00263887|B2|Baseline|Placebo|
318315|NCT00263887|B1|Baseline|Prolastin (60 mg/kg Body Weight)|
318316|NCT00263887|P2|Participant Flow|Placebo|
318317|NCT00263887|P1|Participant Flow|Prolastin (60 mg/kg Body Weight)|
318318|NCT00263887|O2|Outcome|Placebo|
318319|NCT00263887|O1|Outcome|Prolastin (60 mg/kg Body Weight)|
318320|NCT00263887|E2|Reported Event|Placebo|
318235|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318236|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318237|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318238|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318239|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318240|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318241|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318242|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318243|NCT00263328|E3|Reported Event|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318321|NCT00263887|E1|Reported Event|Prolastin (60 mg/kg Body Weight)|
318322|NCT00264004|B5|Baseline|Total|Total of all reporting groups
318323|NCT00264004|B4|Baseline|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
318324|NCT00264004|B3|Baseline|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
318325|NCT00264004|B2|Baseline|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
318326|NCT00264004|B1|Baseline|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
318327|NCT00264004|P4|Participant Flow|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
318244|NCT00263328|E2|Reported Event|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318245|NCT00263328|E1|Reported Event|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
318246|NCT00263666|B3|Baseline|Total|Total of all reporting groups
318247|NCT00263666|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318248|NCT00263666|B1|Baseline|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318249|NCT00263666|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318389|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
318270|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318271|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318272|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318273|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318274|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318275|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318276|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318277|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318278|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318279|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
318338|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
318339|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
318340|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
318341|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
318342|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
318343|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
318344|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
318345|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
318346|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
318347|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
318348|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
318349|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
318350|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
318351|NCT00264004|E4|Reported Event|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
318352|NCT00264004|E3|Reported Event|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
318353|NCT00264004|E2|Reported Event|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
318354|NCT00264004|E1|Reported Event|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
318355|NCT00264147|B6|Baseline|Total|Total of all reporting groups
318356|NCT00264147|B5|Baseline|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
318357|NCT00264147|B4|Baseline|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
318358|NCT00264147|B3|Baseline|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
318359|NCT00264147|B2|Baseline|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
318360|NCT00264147|B1|Baseline|Placebo|Treatment I: Placebo orally once daily
318361|NCT00264147|P6|Participant Flow|Diclofenac 150 mg (Treatment II)|Treatment II: Diclofenac 75 mg orally twice daily
318362|NCT00264147|P5|Participant Flow|Etoricoxib 90 mg|Treatment I and II: Etoricoxib 90 mg orally once daily
318363|NCT00264147|P4|Participant Flow|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
318364|NCT00264147|P3|Participant Flow|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
318365|NCT00264147|P2|Participant Flow|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
318366|NCT00264147|P1|Participant Flow|Placebo|Treatment I: Placebo orally once daily
318367|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
318368|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
318369|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
318370|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
318371|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
318372|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
318373|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
318374|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
318375|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
318376|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
318377|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
318378|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
318379|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
318380|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
318381|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
318382|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
318383|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
318384|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
318385|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
318386|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
318387|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
318388|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
318391|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
318392|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
318393|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
318394|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
318395|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
318396|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
318397|NCT00264147|E7|Reported Event|Diclofenac 150 mg Treatment II Period|Treatment II: Diclofenac 75 mg orally twice daily
318398|NCT00264147|E6|Reported Event|Etoricoxib 90 mg Treatment II Period|Treatment II: Etoricoxib 90 mg orally once daily
318399|NCT00264147|E5|Reported Event|Etoricoxib 90 mg Treatment I Period|Treatment I: Etoricoxib 90 mg orally once daily
318400|NCT00264147|E4|Reported Event|Etoricoxib 60 mg Treatment I Period|Treatment I: Etoricoxib 60 mg orally once daily
318401|NCT00264147|E3|Reported Event|Etoricoxib 30 mg Treatment I Period|Treatment I: Etoricoxib 30 mg orally once daily
318402|NCT00264147|E2|Reported Event|Etoricoxib 10 mg Treatment I Period|Treatment I: Etoricoxib 10 mg orally once daily
318403|NCT00264147|E1|Reported Event|Placebo Treatment I Period|Treatment I: Placebo orally once daily
318404|NCT00264238|B1|Baseline|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.
Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
318405|NCT00264238|P1|Participant Flow|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.
Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
318406|NCT00264238|O2|Outcome|Non-Responders: Memantine Open Label|Participants who did not respond to memantine as adjunctive therapy
318407|NCT00264238|O1|Outcome|Responders: Memantine Open Label|"Participants who respond to memantine as adjunctive therapy; that is, Y-BOCS decrease of greater than or equal to 25% from baseline and a CGI0I rating of much or very much improved."
318408|NCT00264238|O2|Outcome|Non-Responders: Memantine Open Label|Participants who did not respond to memantine as adjunctive therapy
318409|NCT00264238|O1|Outcome|Responders: Memantine Open Label|"Participants who respond to memantine as adjunctive therapy defined as Y-BOCS decrease of greater than or equal to 25% from baseline and a CGI-I rating of much or very much improved."
318410|NCT00264238|E1|Reported Event|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.
Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
318411|NCT00264290|B3|Baseline|Total|Total of all reporting groups
318412|NCT00264290|B2|Baseline|Valganciclovir|"900mg PO qd
Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
318413|NCT00264290|B1|Baseline|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
318414|NCT00264290|P2|Participant Flow|Valganciclovir|"900mg PO qd
Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone."
318415|NCT00264290|P1|Participant Flow|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
318416|NCT00264290|O2|Outcome|Valganciclovir|"900mg PO qd
Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
318417|NCT00264290|O1|Outcome|Placebo|placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
318418|NCT00264290|E2|Reported Event|Valganciclovir|"900mg PO qd
Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
318419|NCT00264290|E1|Reported Event|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
318420|NCT00264303|B3|Baseline|Total|Total of all reporting groups
318421|NCT00264303|B2|Baseline|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
318422|NCT00264303|B1|Baseline|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
318423|NCT00264303|P2|Participant Flow|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
318424|NCT00264303|P1|Participant Flow|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
318425|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
318426|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
318427|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
318428|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
318429|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
318430|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
318431|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
318432|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
318433|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
318434|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
318435|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
318436|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
318437|NCT00264303|E2|Reported Event|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
318438|NCT00264303|E1|Reported Event|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
318439|NCT00264381|B3|Baseline|Total|Total of all reporting groups
318440|NCT00264381|B2|Baseline|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
+ additional 7 days of same therapy based on results of ultrasound at day 7"
318566|NCT00264641|B2|Baseline|Low RAS Activity|Low RAS activity is defined in the protocol
318441|NCT00264381|B1|Baseline|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
+ additional 7 days of same therapy based on result of ultrasound at day 7"
318442|NCT00264381|P2|Participant Flow|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
+ additional 7 days of same therapy based on results of ultrasound at day 7"
318443|NCT00264381|P1|Participant Flow|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
+ additional 7 days of same therapy based on result of ultrasound at day 7"
318444|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
+ additional 7 days of same therapy based on results of ultrasound at day 7"
318445|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
+ additional 7 days of same therapy based on result of ultrasound at day 7"
318446|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
+ additional 7 days of same therapy based on results of ultrasound at day 7"
319251|NCT00267098|B6|Baseline|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
318447|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
+ additional 7 days of same therapy based on result of ultrasound at day 7"
318448|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
+ additional 7 days of same therapy based on results of ultrasound at day 7"
318449|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
+ additional 7 days of same therapy based on result of ultrasound at day 7"
318450|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
+ additional 7 days of same therapy based on results of ultrasound at day 7"
318451|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
+ additional 7 days of same therapy based on result of ultrasound at day 7"
318452|NCT00264381|E2|Reported Event|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
+ additional 7 days of same therapy based on results of ultrasound at day 7"
318453|NCT00264381|E1|Reported Event|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
+ additional 7 days of same therapy based on result of ultrasound at day 7"
318454|NCT00264498|B3|Baseline|Total|Total of all reporting groups
318455|NCT00264498|B2|Baseline|Experimental|Gefitinib
318456|NCT00264498|B1|Baseline|Active Comparator|Gemcitabine + Carboplatin
318457|NCT00264498|P2|Participant Flow|Experimental|Gefitinib
318458|NCT00264498|P1|Participant Flow|Active Comparator|Gemcitabine + Carboplatin
318459|NCT00264498|O2|Outcome|Experimental|Gefitinib
318460|NCT00264498|O1|Outcome|Active Comparator|Gemcitabine + Carboplatin
318461|NCT00264498|E2|Reported Event|Experimental|Gefitinib
318462|NCT00264498|E1|Reported Event|Active Comparator|Gemcitabine + Carboplatin
318463|NCT00264537|B5|Baseline|Total|Total of all reporting groups
318464|NCT00264537|B4|Baseline|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318465|NCT00264537|B3|Baseline|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318466|NCT00264537|B2|Baseline|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318467|NCT00264537|B1|Baseline|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318468|NCT00264537|P4|Participant Flow|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318469|NCT00264537|P3|Participant Flow|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318567|NCT00264641|B1|Baseline|High RAS Activity|High RAS activity is defined in the protocol
321621|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
318470|NCT00264537|P2|Participant Flow|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318471|NCT00264537|P1|Participant Flow|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318472|NCT00264537|O5|Outcome|Combined: Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
318473|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
319252|NCT00267098|B5|Baseline|CRT-P: Not Randomized|Subjects successfully implanted with a CRT-P device who were not randomized
318474|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318475|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318476|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318477|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
318478|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318479|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318480|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318481|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318482|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
318483|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate (MTX)|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318484|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318485|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318486|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318487|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
318488|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318489|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318732|NCT00265122|E5|Reported Event|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
318490|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318491|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318492|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
318493|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318494|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318495|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318496|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318497|NCT00264537|E3|Reported Event|Group C: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2, Group 3 and Group 4, who received Golimumab 50 mg and 100 mg SC Injections.
318498|NCT00264537|E2|Reported Event|Group B: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2 and Group 4, who received only Golimumab 100 mg SC Injections.
318499|NCT00264537|E1|Reported Event|Group A: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study. Participants were included from Group 1 and Group 3, who received only Golimumab 50 mg SC Injections.
318500|NCT00264550|B5|Baseline|Total|Total of all reporting groups
318501|NCT00264550|B4|Baseline|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318568|NCT00264641|P2|Participant Flow|Low RAS Activity|Low RAS was defined as serum ACE and plasma angiotensinogen concentration in the lowest quartiles in the population combined with AT2 receptor genotype G
318569|NCT00264641|P1|Participant Flow|High RAS Activity|High RAS was defined as serum ACE and plasma angiotensinogen concentration in the highest quartiles in the population combined with AT2 receptor genotype A
318502|NCT00264550|B3|Baseline|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318503|NCT00264550|B2|Baseline|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318504|NCT00264550|B1|Baseline|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318505|NCT00264550|P4|Participant Flow|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318786|NCT00256724|E2|Reported Event|Active ITD|active impedance threshold device
318787|NCT00256724|E1|Reported Event|Sham ITD|sham Impedance Threshold Device
318506|NCT00264550|P3|Participant Flow|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318507|NCT00264550|P2|Participant Flow|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318508|NCT00264550|P1|Participant Flow|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318509|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
318510|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318511|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318512|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318513|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318514|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
318515|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318516|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
319290|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
318517|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318518|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318519|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
318520|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318521|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318788|NCT00256750|B4|Baseline|Total|Total of all reporting groups
328577|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
318522|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318523|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318524|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
318525|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318526|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318527|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318528|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318529|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
318530|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318531|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318532|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318533|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318534|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
318535|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318536|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318537|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318972|NCT00257010|E1|Reported Event|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
318538|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
318539|NCT00264550|E3|Reported Event|Group 3: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study.
318540|NCT00264550|E2|Reported Event|Group 2: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study.
318541|NCT00264550|E1|Reported Event|Group 1: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study.
318542|NCT00264576|B3|Baseline|Total|Total of all reporting groups
318543|NCT00264576|B2|Baseline|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
318544|NCT00264576|B1|Baseline|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
318545|NCT00264576|P2|Participant Flow|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
318546|NCT00264576|P1|Participant Flow|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
318547|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
318548|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
318549|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
318550|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
318551|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
318552|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
318553|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
318554|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell- culture-derived trivalent influenza vaccine (cTIV).
318555|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
318556|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
318557|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
318558|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
318559|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
318560|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
318561|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
318562|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
318563|NCT00264576|E2|Reported Event|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
318564|NCT00264576|E1|Reported Event|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
318565|NCT00264641|B3|Baseline|Total|Total of all reporting groups
318570|NCT00264641|O1|Outcome|All Study Participants|From a screening population ten subjects with high RAS activity – defined as serum ACE and plasma angiotensinogen concentrations in the highest quartile in the population combined with presence of AT2 receptor genotype A corresponding to low expression of the receptor (maximum stimulation via the AT1 receptor) – were selected And 10 males with low RAS activity – defined as serum ACE and plasma angiotensinogen concentrations in the lowest quartile in the population combined with the presence of AT2 receptor genotype G corresponding to high expression of the receptor (58) (minimum stimulation via the AT1 receptor) were selected
318571|NCT00264641|E2|Reported Event|Low RAS Activity|Low RAS activity is described in the protocol
318572|NCT00264641|E1|Reported Event|High RAS Activity|High RAS activity is described in the protocol
318573|NCT00264797|B3|Baseline|Total|Total of all reporting groups
318574|NCT00264797|B2|Baseline|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318973|NCT00257166|B3|Baseline|Total|Total of all reporting groups
318974|NCT00257166|B2|Baseline|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
318575|NCT00264797|B1|Baseline|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318576|NCT00264797|P2|Participant Flow|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318577|NCT00264797|P1|Participant Flow|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318578|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318579|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318580|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318581|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318582|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318583|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318601|NCT00264849|B1|Baseline|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318584|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318585|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318586|NCT00264797|E2|Reported Event|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318607|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
328578|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
318587|NCT00264797|E1|Reported Event|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
318588|NCT00264810|B3|Baseline|Total|Total of all reporting groups
318589|NCT00264810|B2|Baseline|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
318590|NCT00264810|B1|Baseline|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
318591|NCT00264810|P2|Participant Flow|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
318592|NCT00264810|P1|Participant Flow|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
318593|NCT00264810|O2|Outcome|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
318594|NCT00264810|O1|Outcome|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
318595|NCT00264810|O1|Outcome|Implanted Subjects|Subjects implanted with the RNS® System.
318596|NCT00264810|O1|Outcome|Implanted Subjects|Subjects implanted with the RNS® System
318597|NCT00264810|E2|Reported Event|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
318598|NCT00264810|E1|Reported Event|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
318599|NCT00264849|B3|Baseline|Total|Total of all reporting groups
318600|NCT00264849|B2|Baseline|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318639|NCT00264875|E1|Reported Event|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
318602|NCT00264849|P2|Participant Flow|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318603|NCT00264849|P1|Participant Flow|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318604|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318605|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318606|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318677|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
318608|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318609|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318610|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318611|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318612|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318613|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318614|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318615|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318616|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318617|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318618|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318619|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318620|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318621|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318622|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318623|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318624|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318625|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318678|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
318626|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318627|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318628|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318629|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318630|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318631|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318632|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318633|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318634|NCT00264849|E2|Reported Event|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
318635|NCT00264849|E1|Reported Event|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
318636|NCT00264875|B1|Baseline|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
318637|NCT00264875|P1|Participant Flow|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
318638|NCT00264875|O1|Outcome|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
318640|NCT00265083|B4|Baseline|Total|Total of all reporting groups
321622|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
318641|NCT00265083|B3|Baseline|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
318642|NCT00265083|B2|Baseline|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318643|NCT00265083|B1|Baseline|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318644|NCT00265083|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
318645|NCT00265083|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318646|NCT00265083|P1|Participant Flow|Group 1: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318647|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
318648|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
318649|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318650|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318651|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
318652|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
318653|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318654|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318655|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
318656|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
318657|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318658|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318659|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
318660|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
318661|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318662|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
318663|NCT00265083|E3|Reported Event|Group 3: Golimumab 50 and 100 mg|Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
318664|NCT00265083|E2|Reported Event|Group 2: Golimumab 100 mg|Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.
318665|NCT00265083|E1|Reported Event|Group 1: Golimumab 50 mg|Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.
318666|NCT00265096|B4|Baseline|Total|Total of all reporting groups
318667|NCT00265096|B3|Baseline|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
318668|NCT00265096|B2|Baseline|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318669|NCT00265096|B1|Baseline|Group 1: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318670|NCT00265096|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
318766|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
318671|NCT00265096|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318672|NCT00265096|P1|Participant Flow|Group 1: Placebo|Group 1: Placebo Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318673|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
318674|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
318675|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318676|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318679|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318680|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318681|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
318682|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
318683|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318684|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318685|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
318686|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
318687|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318688|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318689|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
318690|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
318691|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318692|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318693|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
318694|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
318695|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318696|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
318697|NCT00265096|E3|Reported Event|Group 3: Golimumab 50 and 100 mg|Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
318698|NCT00265096|E2|Reported Event|Group 2: Golimumab 100 mg|Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.
318699|NCT00265096|E1|Reported Event|Group 1: Golimumab 50 mg|Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.
318700|NCT00265109|B1|Baseline|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
318701|NCT00265109|P1|Participant Flow|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
318702|NCT00265109|O1|Outcome|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
319253|NCT00267098|B4|Baseline|CRT-P: Right Ventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
318703|NCT00265109|E1|Reported Event|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
318704|NCT00265122|B7|Baseline|Total|Total of all reporting groups
318705|NCT00265122|B6|Baseline|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
318706|NCT00265122|B5|Baseline|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
318707|NCT00265122|B4|Baseline|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
318708|NCT00265122|B3|Baseline|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
318709|NCT00265122|B2|Baseline|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
318710|NCT00265122|B1|Baseline|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
318711|NCT00265122|P6|Participant Flow|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
318712|NCT00265122|P5|Participant Flow|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
318713|NCT00265122|P4|Participant Flow|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
318714|NCT00265122|P3|Participant Flow|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
318715|NCT00265122|P2|Participant Flow|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
318716|NCT00265122|P1|Participant Flow|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
318717|NCT00265122|O6|Outcome|Population 1: Ustekinumab SC and IV Combined|All participants who received Ustekinumab SC and Ustekinumab IV
318718|NCT00265122|O5|Outcome|Population 1: Placebo SC and IV Combined|All participants who received Placebo SC and Placebo IV
318719|NCT00265122|O4|Outcome|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
318720|NCT00265122|O3|Outcome|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
318721|NCT00265122|O2|Outcome|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
318722|NCT00265122|O1|Outcome|Population 1:Placebo SC Followed by Ustekinumab 90 mg SC|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 1, 2, 3 (Intervention Period 1: Weeks 0-8), and 90 mg ustekinumab SC at Weeks 8, 9, 10 and 11 (Intervention Period 2: Weeks 8-28)
318723|NCT00265122|O2|Outcome|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
318724|NCT00265122|O1|Outcome|Population 2: Ustekinumab 90 SC|Paticipants received ustekinumab 90 mg subcutaneously (SC) at Weeks 0, 1, 2, and 3 (Intervention Period 1: Weeks 0-8), and did not receive any study agent from Week 8 onward (Intervention Period 2: Weeks 8-28)
318725|NCT00265122|O6|Outcome|Population 1: Ustekinumab SC and IV Combined|All participants who received Ustekinumab 90 mg SC and Ustekinumab 4.5 mg/kg IV
318726|NCT00265122|O5|Outcome|Population 1: Placebo SC and IV Combined|All particpants who received Placebo SC and Placebo IV
318727|NCT00265122|O4|Outcome|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
318728|NCT00265122|O3|Outcome|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
318729|NCT00265122|O2|Outcome|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
318730|NCT00265122|O1|Outcome|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
318731|NCT00265122|E6|Reported Event|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
318733|NCT00265122|E4|Reported Event|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|"Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 26 participants randomized to this treatment group + 1 participant randomized to treatment with Placebo IV followed by Ustekinumab 4.5 mg/kg IV who received ustekinumab IV at Week 0 was included in the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below."
318734|NCT00265122|E3|Reported Event|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|"Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 8 of 27 participants randomized to this treatment group were excluded from the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below for the following reasons: 7 participants received placebo only were excluded from the analysis of adverse events and 1 participant received ustekinumab IV at Week 0 and was included in the analysis of adverse events in the treatment group labelled Ustekinumab 4.5 mg/kg IV followed by Placebo IV."
318735|NCT00265122|E2|Reported Event|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
318736|NCT00265122|E1|Reported Event|Population 1: Placebo SC Followed by Ustekinumab SC|"Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2. NOTE: 4 of 26 participants randomized to this treatment group received placebo only and were excluded from the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below."
318737|NCT00265200|B1|Baseline|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
318738|NCT00265200|P1|Participant Flow|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
318739|NCT00265200|O1|Outcome|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
318740|NCT00265200|E1|Reported Event|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
318741|NCT00265239|B3|Baseline|Total|Total of all reporting groups
318742|NCT00265239|B2|Baseline|Placebo Group|Placebo Group
318743|NCT00265239|B1|Baseline|Edaravone Group|"Edaravone Group
edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
318744|NCT00265239|P2|Participant Flow|Placebo Group|Placebo Group
318745|NCT00265239|P1|Participant Flow|Edaravone Group|"Edaravone Group
edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
318746|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
318747|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group
edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
318748|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
318749|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group
edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
318750|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
318751|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group
edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
318752|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
318753|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group
edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
318754|NCT00265239|E2|Reported Event|Placebo Group|Placebo Group
318755|NCT00265239|E1|Reported Event|Edaravone Group|"Edaravone Group
edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
318756|NCT00256698|B3|Baseline|Total|Total of all reporting groups
318757|NCT00256698|B2|Baseline|Anastrozole|Anastrozole 1 mg
318758|NCT00256698|B1|Baseline|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
318759|NCT00256698|P2|Participant Flow|Anastrozole|Anastrozole 1 mg
318760|NCT00256698|P1|Participant Flow|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
318761|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
318762|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
318763|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
318764|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
318765|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
318768|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
318769|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
318770|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
318771|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
318772|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
318773|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
318774|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
318775|NCT00256698|E2|Reported Event|Anastrozole|Anastrozole 1 mg
318776|NCT00256698|E1|Reported Event|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
318777|NCT00256724|B3|Baseline|Total|Total of all reporting groups
318778|NCT00256724|B2|Baseline|Active ITD|active impedance threshold device
318779|NCT00256724|B1|Baseline|Sham ITD|sham Impedance Threshold Device
318780|NCT00256724|P2|Participant Flow|Active ITD|active impedance threshold device
318781|NCT00256724|P1|Participant Flow|Sham ITD|sham Impedance Threshold Device
318782|NCT00256724|O2|Outcome|Active ITD|active impedance threshold device
318783|NCT00256724|O1|Outcome|Sham ITD|sham Impedance Threshold Device
318784|NCT00256724|O2|Outcome|Active ITD|active impedance threshold device
318785|NCT00256724|O1|Outcome|Sham ITD|sham Impedance Threshold Device
318789|NCT00256750|B3|Baseline|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318790|NCT00256750|B2|Baseline|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318791|NCT00256750|B1|Baseline|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318792|NCT00256750|P3|Participant Flow|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318793|NCT00256750|P2|Participant Flow|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318794|NCT00256750|P1|Participant Flow|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318795|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318796|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318797|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318798|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318799|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318800|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318801|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318802|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318803|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318804|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318805|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318806|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318807|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
319044|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
318808|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318809|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318810|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318811|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318812|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318813|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318814|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318815|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318816|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318817|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318818|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318819|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318820|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318821|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318822|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318823|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318824|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318825|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318826|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318827|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318828|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318829|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318830|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318831|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318832|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318833|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318834|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318835|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318836|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318837|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318838|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318839|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318840|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
319535|NCT00267774|P1|Participant Flow|FFR Guided PCI|Fractional flow reserve
318841|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318842|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318843|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318844|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318845|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318846|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318847|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318848|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318849|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318850|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318851|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318852|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318853|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318854|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318855|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318856|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318857|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318858|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318859|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318860|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318861|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318862|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318863|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318864|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318865|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318866|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
319257|NCT00267098|P8|Participant Flow|CRT-D: Not Randomized|Subjects successfully implanted with a CRT-D device who were not randomized
318867|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318868|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318869|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318870|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318871|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318872|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318873|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318874|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318875|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318876|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318877|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318878|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318879|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318880|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318881|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318882|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318883|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318884|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318885|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
321623|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
318886|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318887|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318888|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318889|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318890|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318891|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318892|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
319054|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
318893|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318894|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318895|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318896|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318897|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318898|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318899|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318900|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318901|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318902|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318903|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318904|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318905|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318906|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318907|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318908|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318909|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318910|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318911|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318912|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318913|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318914|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318915|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318916|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318917|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318918|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
319055|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
318919|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318920|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318921|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318922|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318923|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318924|NCT00256750|E3|Reported Event|Belatacept - MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318925|NCT00256750|E2|Reported Event|Belatacept - LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
318926|NCT00256750|E1|Reported Event|Cyclosporine|"Cyclosporine (CsA): tablet, oral
1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
318927|NCT00256984|B1|Baseline|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
318928|NCT00256984|P1|Participant Flow|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
318929|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
318930|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
318931|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
318932|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
318933|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
318934|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
318935|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
318936|NCT00256984|E1|Reported Event|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
318937|NCT00256997|B3|Baseline|Total|Total of all reporting groups
319212|NCT00265473|B1|Baseline|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
318938|NCT00256997|B2|Baseline|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
318939|NCT00256997|B1|Baseline|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318940|NCT00256997|P2|Participant Flow|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
318941|NCT00256997|P1|Participant Flow|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318942|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
318943|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318944|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
319254|NCT00267098|B3|Baseline|CRT-P: Biventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
318945|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318946|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
318947|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318948|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
318949|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318950|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
318951|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318952|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
318953|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318954|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
318955|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318956|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
318957|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318958|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
318959|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318960|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
319291|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
318961|NCT00256997|O1|Outcome|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318962|NCT00256997|E2|Reported Event|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
318963|NCT00256997|E1|Reported Event|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
318964|NCT00257010|B1|Baseline|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
318965|NCT00257010|P1|Participant Flow|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
318966|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
318967|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
318968|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
318969|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
318970|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
318971|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
318975|NCT00257166|B1|Baseline|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
318976|NCT00257166|P2|Participant Flow|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
318977|NCT00257166|P1|Participant Flow|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
318978|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
318979|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
318980|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
318981|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
318982|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
318983|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
318984|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
319041|NCT00265317|P1|Participant Flow|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
319292|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
318985|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
318986|NCT00257166|E2|Reported Event|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
318987|NCT00257166|E1|Reported Event|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
318988|NCT00257192|B3|Baseline|Total|Total of all reporting groups
318989|NCT00257192|B2|Baseline|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319056|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319057|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
318990|NCT00257192|B1|Baseline|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
318991|NCT00257192|P2|Participant Flow|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
318992|NCT00257192|P1|Participant Flow|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
318993|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
318994|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
318995|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
318996|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
318997|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319042|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
318998|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
318999|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319000|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319001|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319002|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319058|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319308|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319003|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319004|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319005|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319006|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319007|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319008|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319009|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319010|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319011|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319012|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319013|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319014|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319015|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319059|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319536|NCT00267774|O2|Outcome|Angio-guided PCI|Angio-guided PCI
319016|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319017|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319018|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319019|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319020|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319021|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319022|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319023|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319024|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319025|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319026|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319027|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319028|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319060|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319309|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319029|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319030|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319031|NCT00257192|E2|Reported Event|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319032|NCT00257192|E1|Reported Event|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
319033|NCT00265317|B5|Baseline|Total|Total of all reporting groups
319034|NCT00265317|B4|Baseline|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319035|NCT00265317|B3|Baseline|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
319036|NCT00265317|B2|Baseline|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
319037|NCT00265317|B1|Baseline|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
319038|NCT00265317|P4|Participant Flow|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319039|NCT00265317|P3|Participant Flow|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
319040|NCT00265317|P2|Participant Flow|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
319043|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319045|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319046|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319047|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319048|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319049|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319050|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319051|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319052|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319053|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319255|NCT00267098|B2|Baseline|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
319061|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319062|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319063|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319064|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319065|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319066|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319067|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319068|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319069|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319070|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319071|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319072|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319073|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319074|NCT00265317|O1|Outcome|All Participants|All participants in all phases.
319075|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319076|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319077|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319078|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319079|NCT00265317|O1|Outcome|All Participants|All participants in all phases
319080|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319081|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319082|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319213|NCT00265473|P1|Participant Flow|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
319083|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319084|NCT00265317|O1|Outcome|All Participants|All participants in all phases.
319085|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319086|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319087|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319088|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319089|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319090|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319091|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319092|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319093|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319094|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319095|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319096|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319097|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319098|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319099|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319100|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319101|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319102|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319103|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319104|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319105|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319106|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319107|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319108|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319109|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
319110|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
319111|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
319112|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
319113|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
319114|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
319214|NCT00265473|O1|Outcome|Experimental|Islet infusion
319215|NCT00265473|O1|Outcome|Experimental|Islet infusion
319115|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319116|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319117|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319118|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
319119|NCT00265317|O2|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319120|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days)and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
319121|NCT00265317|O2|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
319122|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
319123|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319124|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
319310|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319125|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319126|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319127|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319128|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
319129|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319130|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319131|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319132|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
319133|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319134|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319135|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
319136|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
319137|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319138|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319139|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319140|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319141|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319142|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319143|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319144|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319145|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319146|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319147|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319148|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
319149|NCT00265317|E4|Reported Event|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
319150|NCT00265317|E3|Reported Event|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
319151|NCT00265317|E2|Reported Event|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
319152|NCT00265317|E1|Reported Event|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
319153|NCT00265330|B1|Baseline|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319311|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319154|NCT00265330|P1|Participant Flow|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319155|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319156|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319157|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319158|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319159|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319160|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319161|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319162|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319163|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319164|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319216|NCT00265473|O1|Outcome|Experimental|Islet infusion
319165|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319166|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319167|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319168|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319169|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319170|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319256|NCT00267098|B1|Baseline|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
319171|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319172|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319173|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319174|NCT00265330|E1|Reported Event|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
319175|NCT00265343|B3|Baseline|Total|Total of all reporting groups
319176|NCT00265343|B2|Baseline|Olanzapine|5-20 mg daily (QD) orally (PO)
319177|NCT00265343|B1|Baseline|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
319178|NCT00265343|P2|Participant Flow|Olanzapine|5-20 mg daily (QD) orally (PO)
319179|NCT00265343|P1|Participant Flow|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
319180|NCT00265343|O2|Outcome|Olanzapine|5-20 mg daily (QD) orally (PO)
319181|NCT00265343|O1|Outcome|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
319182|NCT00265343|O2|Outcome|Olanzapine|5-20 mg daily (QD) orally (PO)
319183|NCT00265343|O1|Outcome|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
319184|NCT00265343|E2|Reported Event|Olanzapine|
319185|NCT00265343|E1|Reported Event|Asenapine|
319186|NCT00265382|B1|Baseline|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319187|NCT00265382|P1|Participant Flow|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319188|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319189|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319210|NCT00265395|O1|Outcome|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
319190|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319191|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319192|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319193|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319194|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319195|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319196|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319227|NCT00265512|E2|Reported Event|Arm 2|"Continuing Care as Usual
Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.
SAEs were tracked, but AEs were not tracked."
319197|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319198|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319199|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319200|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319201|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319202|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319203|NCT00265382|E1|Reported Event|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
319204|NCT00265395|B3|Baseline|Total|Total of all reporting groups
319205|NCT00265395|B2|Baseline|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
319206|NCT00265395|B1|Baseline|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
319207|NCT00265395|P2|Participant Flow|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
319208|NCT00265395|P1|Participant Flow|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
319209|NCT00265395|O2|Outcome|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
319217|NCT00265473|O1|Outcome|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
319218|NCT00265473|O1|Outcome|Experimental|Islet infusion
319219|NCT00265473|E1|Reported Event|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
319220|NCT00265512|B3|Baseline|Total|Total of all reporting groups
319221|NCT00265512|B2|Baseline|Arm 2|"Continuing Care as Usual
Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
319222|NCT00265512|B1|Baseline|Arm 1|"Telephone Case Monitoring Aftercare
Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
319223|NCT00265512|P2|Participant Flow|Arm 2|"Continuing Care as Usual
Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
319224|NCT00265512|P1|Participant Flow|Arm 1|"Telephone Case Monitoring Aftercare
Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
319225|NCT00265512|O2|Outcome|Arm 2|"Continuing Care as Usual
Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
319226|NCT00265512|O1|Outcome|Arm 1|"Telephone Case Monitoring Aftercare
Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
319250|NCT00267098|B7|Baseline|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
319228|NCT00265512|E1|Reported Event|Arm 1|"Telephone Case Monitoring Aftercare
Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
SAEs were tracked, but AEs were not tracked."
319229|NCT00267046|B3|Baseline|Total|Total of all reporting groups
319230|NCT00267046|B2|Baseline|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):
AI = Doxorubicin (Adriamycin) + Ifosfamide:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
319231|NCT00267046|B1|Baseline|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);
AI = Doxorubicin (Adriamycin) + Ifosfamide:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
319232|NCT00267046|P2|Participant Flow|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):
AI = Doxorubicin (Adriamycin) + Ifosfamide:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
319233|NCT00267046|P1|Participant Flow|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);
AI = Doxorubicin (Adriamycin) + Ifosfamide:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
319234|NCT00267046|O2|Outcome|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):
AI = Doxorubicin (Adriamycin) + Ifosfamide:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
319235|NCT00267046|O1|Outcome|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);
AI = Doxorubicin (Adriamycin) + Ifosfamide:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
319236|NCT00267046|O2|Outcome|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):
AI = Doxorubicin (Adriamycin) + Ifosfamide:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
319237|NCT00267046|O1|Outcome|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);
AI = Doxorubicin (Adriamycin) + Ifosfamide:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
319287|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319288|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319289|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319411|NCT00267150|E1|Reported Event|All Patients|All patients
319238|NCT00267046|E2|Reported Event|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):
AI = Doxorubicin (Adriamycin) + Ifosfamide:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
319239|NCT00267046|E1|Reported Event|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);
AI = Doxorubicin (Adriamycin) + Ifosfamide:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
319240|NCT00267059|B1|Baseline|Lenalidomide|10 mg/day, orally once a day for 28 days
319241|NCT00267059|P1|Participant Flow|Lenalidomide|10 mg/day, orally once a day for 28 days
319242|NCT00267059|O1|Outcome|Lenalidomide|10 mg/day, orally once a day for 28 days
319243|NCT00267059|E1|Reported Event|Lenalidomide|10 mg/day, orally once a day for 28 days
319244|NCT00267085|B1|Baseline|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
319245|NCT00267085|P1|Participant Flow|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
319246|NCT00267085|O1|Outcome|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
319247|NCT00267085|E1|Reported Event|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
319248|NCT00267098|B9|Baseline|Total|Total of all reporting groups
319249|NCT00267098|B8|Baseline|CRT-D: Not Randomized|Subjects successfully implanted with a CRT-D device who were not randomized
319312|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319258|NCT00267098|P7|Participant Flow|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
319259|NCT00267098|P6|Participant Flow|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
319260|NCT00267098|P5|Participant Flow|CRT-P: Not Randomized|Subjects successfully implanted with a CRT-P device who were not randomized
319261|NCT00267098|P4|Participant Flow|CRT-P: Right Ventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
319262|NCT00267098|P3|Participant Flow|CRT-P: Biventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
319263|NCT00267098|P2|Participant Flow|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
319264|NCT00267098|P1|Participant Flow|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
319265|NCT00267098|O2|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
319266|NCT00267098|O1|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
319267|NCT00267098|O2|Outcome|Subjects With a CRT-D Implant Attempt|Subjects who underwent an implant attempt for a CRT-D device
319268|NCT00267098|O1|Outcome|Subjects With a CRT-P Implant Attempt|Subjects who underwent an implant attempt for a CRT-P device
319269|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure
319270|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure
319271|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure
319272|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure
319273|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure
319274|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure
319275|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319276|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319277|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319278|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319279|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319280|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319281|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319282|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319283|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319284|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319285|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319286|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319412|NCT00267189|B3|Baseline|Total|Total of all reporting groups
319293|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319294|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319295|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319296|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319297|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319298|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319299|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319300|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319301|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319302|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319303|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319304|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319305|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319306|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319307|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319313|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319314|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319315|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319316|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319317|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319318|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319319|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319320|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319321|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319322|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319323|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319324|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319325|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319326|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319327|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319328|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319329|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319330|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319331|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319332|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319333|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319334|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319335|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319336|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319337|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319338|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319339|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319340|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319341|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319342|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319343|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319344|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319345|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319346|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319347|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319348|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319349|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319350|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319351|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319352|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319353|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319354|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319355|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319356|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319357|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319358|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319359|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319360|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319361|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319362|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319363|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319364|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319365|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319366|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319367|NCT00267098|O4|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
319368|NCT00267098|O3|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
319369|NCT00267098|O2|Outcome|CRT-P: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
319370|NCT00267098|O1|Outcome|CRT-P: Biventricular Pacing Arm|Subjects implanted with a CRT-P device and randomized to receive biventricular pacing
319371|NCT00267098|O4|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
319372|NCT00267098|O3|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
319373|NCT00267098|O2|Outcome|CRT-P: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
319374|NCT00267098|O1|Outcome|CRT-P: Biventricular Pacing Arm|Subjects implanted with a CRT-P device and randomized to receive biventricular pacing
319375|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319376|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319377|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319378|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319379|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319380|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319381|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319382|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319383|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319384|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319385|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319386|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319387|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319388|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319389|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
319390|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
319391|NCT00267098|E5|Reported Event|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
319392|NCT00267098|E4|Reported Event|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
319393|NCT00267098|E3|Reported Event|CRT: Not Randomized|Subjects successfully implanted with a CRT device who were not randomized
319394|NCT00267098|E2|Reported Event|Right Ventricular Pacing Arm|Subjects who were implanted with a CRT device and randomized to receive right ventricular pacing
319395|NCT00267098|E1|Reported Event|Biventricular Pacing Arm|Subjects who were implanted with a CRT device and randomized to receive biventricular pacing
319396|NCT00267111|B3|Baseline|Total|Total of all reporting groups
319397|NCT00267111|B2|Baseline|Placebo Group|1 g Eucerin plus was used as a placebo.
319398|NCT00267111|B1|Baseline|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
319399|NCT00267111|P2|Participant Flow|Placebo Group|1 g Eucerin plus was used as a placebo.
319400|NCT00267111|P1|Participant Flow|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
319401|NCT00267111|O2|Outcome|Placebo Group|1 g Eucerin plus was used as a placebo
319402|NCT00267111|O1|Outcome|Amethocaine Gel 4% Group|1 g Amethocaine gel 4% was used as the active drug
319403|NCT00267111|O2|Outcome|Placebo Group|1 g Eucerin plus was used as a placebo
319404|NCT00267111|O1|Outcome|1 g Amethocaine Gel 4%|1 g Amethocaine gel 4% was used as the active drug
319405|NCT00267111|E2|Reported Event|Placebo Group|1 g Eucerin plus was used as a placebo.
319406|NCT00267111|E1|Reported Event|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
319407|NCT00267150|B1|Baseline|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
319408|NCT00267150|P1|Participant Flow|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
319409|NCT00267150|O1|Outcome|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
319410|NCT00267150|O1|Outcome|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
319413|NCT00267189|B2|Baseline|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
319414|NCT00267189|B1|Baseline|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
319415|NCT00267189|P2|Participant Flow|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
319416|NCT00267189|P1|Participant Flow|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
319417|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
319418|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
319419|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
319420|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
319421|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
319422|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
319423|NCT00267189|E2|Reported Event|Group 2 (Control)|Standard calcineurin inhibitor dose ± mycophenolate acid/azathioprine ± steroids
319424|NCT00267189|E1|Reported Event|Group 1 (Everolimus)|Reduced calcineurin inhibitor dose + everolimus (1.5 mg twice daily) ± steroids
319426|NCT00267202|B2|Baseline|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319427|NCT00267202|B1|Baseline|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319428|NCT00267202|P2|Participant Flow|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319429|NCT00267202|P1|Participant Flow|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319430|NCT00267202|O3|Outcome|All Patients|
319431|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319432|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319433|NCT00267202|O3|Outcome|All Patients|
319434|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319435|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319436|NCT00267202|O3|Outcome|All Patients|
319437|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319438|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319439|NCT00267202|O3|Outcome|All Patients|
319440|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319441|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319442|NCT00267202|O3|Outcome|All Patients|
319443|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319444|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319445|NCT00267202|E2|Reported Event|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319493|NCT00267670|P1|Participant Flow|Pentoxifylline|This group was given pentoxifylline 400mg thrice daily (tid) for 1 year
321624|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
319446|NCT00267202|E1|Reported Event|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
319447|NCT00267293|B4|Baseline|Total|Total of all reporting groups
319448|NCT00267293|B3|Baseline|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
319449|NCT00267293|B2|Baseline|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
319450|NCT00267293|B1|Baseline|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
319451|NCT00267293|P3|Participant Flow|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
319452|NCT00267293|P2|Participant Flow|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
319453|NCT00267293|P1|Participant Flow|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
319454|NCT00267293|O3|Outcome|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
319537|NCT00267774|O1|Outcome|FFR Guided PCI|Fractional flow reserve
319455|NCT00267293|O2|Outcome|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
319456|NCT00267293|O1|Outcome|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
319457|NCT00267293|E3|Reported Event|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
319458|NCT00267293|E2|Reported Event|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
319459|NCT00267293|E1|Reported Event|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
319460|NCT00267488|B1|Baseline|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
319461|NCT00267488|P1|Participant Flow|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
319462|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
319463|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
319464|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
319465|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
319466|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
319467|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
319468|NCT00267488|E1|Reported Event|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
319469|NCT00267631|B3|Baseline|Total|Total of all reporting groups
319470|NCT00267631|B2|Baseline|Normal Body Weight|Children with a BMI of 25 to 75%
319471|NCT00267631|B1|Baseline|At Risk Body Weight|Children with BMI greater adn equal to 85%
319472|NCT00267631|P2|Participant Flow|NOrmal Body Weight|Children with BMI of 25-75%
319473|NCT00267631|P1|Participant Flow|At Risk Body Weight|Children with BMI greater and equal to 85%
319474|NCT00267631|O2|Outcome|Normal Body Weight|Children with BMI of 25-75%
319475|NCT00267631|O1|Outcome|At Risk Body Weight|Children with BMI greater and equal to 85%
319476|NCT00267631|E2|Reported Event|Normal Body Weight|Children with a BMI of 25 to 75%
319477|NCT00267631|E1|Reported Event|At Risk Body Weight|Children with a BMI greater and equal to 85%
319478|NCT00267644|B3|Baseline|Total|Total of all reporting groups
319479|NCT00267644|B2|Baseline|Controls|
319480|NCT00267644|B1|Baseline|Cases|
319481|NCT00267644|P2|Participant Flow|Controls|Hydrated Pediatric Patients
319482|NCT00267644|P1|Participant Flow|Cases|Dehydrated Pediatric Patients
319483|NCT00267644|O2|Outcome|Controls|Hydrated Pediatric Patients
319484|NCT00267644|O1|Outcome|Cases|Dehydrated Pediatric Patients
319485|NCT00267644|O2|Outcome|Controls|Pediatric Patients that were hydrated
319486|NCT00267644|O1|Outcome|Cases|Pediatric Patients who were dehydrated
319487|NCT00267644|E2|Reported Event|Controls|
319488|NCT00267644|E1|Reported Event|Cases|
319489|NCT00267670|B3|Baseline|Total|Total of all reporting groups
319490|NCT00267670|B2|Baseline|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
319491|NCT00267670|B1|Baseline|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
319492|NCT00267670|P2|Participant Flow|Placebo|This group was given a capsule identical to pentoxifylline that contained sucrose.
319494|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
319495|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
319496|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
319497|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
319498|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
319499|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
319500|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
319501|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
319502|NCT00267670|E2|Reported Event|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
319503|NCT00267670|E1|Reported Event|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
319538|NCT00267774|E2|Reported Event|Angio-guided PCI|Angio-guided PCI
319539|NCT00267774|E1|Reported Event|FFR Guided PCI|Fractional flow reserve
319540|NCT00267956|B3|Baseline|Total|Total of all reporting groups
319504|NCT00267696|B1|Baseline|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administred on day 1 and day 15 of a 28 day cycle
Carboplatin"
319505|NCT00267696|P1|Participant Flow|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Carboplatin"
319506|NCT00267696|O1|Outcome|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Carboplatin"
319507|NCT00267696|O1|Outcome|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Carboplatin"
319508|NCT00267696|E1|Reported Event|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Carboplatin"
319509|NCT00267748|B4|Baseline|Total|Total of all reporting groups
319510|NCT00267748|B3|Baseline|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
319511|NCT00267748|B2|Baseline|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
319512|NCT00267748|B1|Baseline|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
319513|NCT00267748|P3|Participant Flow|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
319514|NCT00267748|P2|Participant Flow|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
319515|NCT00267748|P1|Participant Flow|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
319516|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
319517|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
319518|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
319519|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
319520|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
319521|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
319522|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
319523|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
321625|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
319524|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
319525|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
319526|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
319527|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
319528|NCT00267748|E3|Reported Event|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
319529|NCT00267748|E2|Reported Event|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
319530|NCT00267748|E1|Reported Event|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
319531|NCT00267774|B3|Baseline|Total|Total of all reporting groups
319532|NCT00267774|B2|Baseline|Angio-guided PCI|Angio-guided PCI
319541|NCT00267956|B2|Baseline|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
319542|NCT00267956|B1|Baseline|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
319543|NCT00267956|P4|Participant Flow|Ustekinumab x 4 (After CP)|After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
319544|NCT00267956|P3|Participant Flow|Placebo -> Ustekinumab (After CP)|After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16
319545|NCT00267956|P2|Participant Flow|Ustekinumab x 4 (CP)|Controlled period (Week 0-12) - Ustekinumab x 4 Group
319546|NCT00267956|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
319547|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
319548|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
319549|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
319550|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
319551|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
319552|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
319553|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
319554|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
319555|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
319556|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
319587|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
321626|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
319557|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
319558|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
319559|NCT00267956|E4|Reported Event|Ustekinumab x 4 (After CP)|After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
319560|NCT00267956|E3|Reported Event|Placebo -> Ustekinumab (After CP)|After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16
319561|NCT00267956|E2|Reported Event|Ustekinumab x 4 (CP)|Controlled period (Week 0-12) - Ustekinumab (CNTO 1275) x 4 Group
319562|NCT00267956|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
319563|NCT00267969|B4|Baseline|Total|Total of all reporting groups
319564|NCT00267969|B3|Baseline|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
319565|NCT00267969|B2|Baseline|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
321025|NCT00262600|P2|Participant Flow|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
319566|NCT00267969|B1|Baseline|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
319567|NCT00267969|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
319568|NCT00267969|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
319569|NCT00267969|P5|Participant Flow|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
319570|NCT00267969|P4|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
319571|NCT00267969|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
319572|NCT00267969|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
319573|NCT00267969|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
319574|NCT00267969|O6|Outcome|Group 6: Combined Ustekinumab Every 12 Weeks|Groups 2 and 4 (Combined Ustekinumab every 12 weeks)
319575|NCT00267969|O5|Outcome|Group 5: Withdrawal Combined Group|Groups 1 and 3 (Withdrawal Combined)
319576|NCT00267969|O4|Outcome|Group 4: Ustekinumab 90 mg Every 12 Weeks|Patients received ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40.
319577|NCT00267969|O3|Outcome|Group 3: Ustekinumab 90 mg Withdrawal|Patients received ustekinumab 90 mg at Weeks 0, 4, 16 and 28.
319578|NCT00267969|O2|Outcome|Group 2: Ustekinumab 45 mg Every 12 Weeks|Patients received ustekinumab 45 mg at Weeks 0, 4, 16, 28 and 40.
319579|NCT00267969|O1|Outcome|Group 1: Ustekinumab 45 mg Withdrawal Group|Patients received ustekinumab 45 mg at Weeks 0, 4, 16 and 28.
319580|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
319581|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
319582|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
319583|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
319584|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
319585|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
319586|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
321627|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
319588|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
319589|NCT00267969|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
319590|NCT00267969|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
319591|NCT00267969|E5|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
319592|NCT00267969|E4|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
319593|NCT00267969|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
319594|NCT00267969|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
319595|NCT00267969|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
319596|NCT00268203|B1|Baseline|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
319597|NCT00268203|P1|Participant Flow|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
319598|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
319599|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
319600|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
319609|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.
Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours
Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
320315|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
319601|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
319602|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
319615|NCT00268242|E1|Reported Event|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.
Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours
Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
319616|NCT00268346|B3|Baseline|Total|Total of all reporting groups
320825|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
319603|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
319604|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
319605|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
319606|NCT00268203|E1|Reported Event|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
319607|NCT00268242|B1|Baseline|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.
Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours
Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
319608|NCT00268242|P1|Participant Flow|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.
Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours
Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
320350|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
319610|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.
Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours
Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
319611|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.
Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours
Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
319612|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.
Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours
Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
319613|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.
Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours
Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
319614|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.
Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours
Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
320826|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
319617|NCT00268346|B2|Baseline|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
319618|NCT00268346|B1|Baseline|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
319619|NCT00268346|P2|Participant Flow|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
319620|NCT00268346|P1|Participant Flow|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
319621|NCT00268346|O2|Outcome|Prior Chemotherapy|All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
319622|NCT00268346|O1|Outcome|No Prior Therapy|All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
319623|NCT00268346|E2|Reported Event|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
319624|NCT00268346|E1|Reported Event|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
319625|NCT00268437|B1|Baseline|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation >
> carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. >
> Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. >
> conventional surgery >
> neoadjuvant therapy >
> radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field)."
319626|NCT00268437|P1|Participant Flow|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
Conventional surgery"
319627|NCT00268437|O1|Outcome|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
Conventional surgery"
319628|NCT00268437|O1|Outcome|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
conventional surgery"
319629|NCT00268437|E1|Reported Event|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
Conventional surgery"
319630|NCT00268463|B3|Baseline|Total|Total of all reporting groups
319631|NCT00268463|B2|Baseline|Floxuridine + Oxaliplatin + Capecitabine|Floxuridine + Oxaliplatin + Capecitabine
319632|NCT00268463|B1|Baseline|Capecitabine + Oxaliplatin|Capecitabine + Oxaliplatin
320351|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
319633|NCT00268463|P2|Participant Flow|Arm 2: Floxuridine + Oxaliplatin + Capecitabine|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles
Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles
Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles"
319634|NCT00268463|P1|Participant Flow|Arm 1: Capecitabine + Oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1
Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1"
319635|NCT00268463|O2|Outcome|Arm 2: Floxuridine + Oxaliplatin + Capecitabine|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles
Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles
Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles"
319636|NCT00268463|O1|Outcome|Arm 1: Capecitabine + Oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1
Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1"
319637|NCT00268463|E2|Reported Event|Floxuridine + Oxaliplatin + Capecitabine|Floxuridine + Oxaliplatin + Capecitabine
319638|NCT00268463|E1|Reported Event|Capecitabine + Oxaliplatin|Capecitabine + Oxaliplatin
319639|NCT00268762|B1|Baseline|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
319640|NCT00268762|P1|Participant Flow|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target partial thromboplastin time (PTT) of 1.75 times the patient's baseline.
319641|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
319642|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
319643|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
319644|NCT00268762|E1|Reported Event|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
319645|NCT00268892|B4|Baseline|Total|Total of all reporting groups
319646|NCT00268892|B3|Baseline|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319647|NCT00268892|B2|Baseline|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319648|NCT00268892|B1|Baseline|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319649|NCT00268892|P3|Participant Flow|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319650|NCT00268892|P2|Participant Flow|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319651|NCT00268892|P1|Participant Flow|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319652|NCT00268892|O3|Outcome|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319653|NCT00268892|O2|Outcome|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319654|NCT00268892|O1|Outcome|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319655|NCT00268892|O3|Outcome|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319656|NCT00268892|O2|Outcome|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319657|NCT00268892|O1|Outcome|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319893|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319658|NCT00268892|E3|Reported Event|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319659|NCT00268892|E2|Reported Event|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319660|NCT00268892|E1|Reported Event|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
319661|NCT00268905|B4|Baseline|Total|Total of all reporting groups
319662|NCT00268905|B3|Baseline|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
319663|NCT00268905|B2|Baseline|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
319664|NCT00268905|B1|Baseline|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
319665|NCT00268905|P3|Participant Flow|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
319666|NCT00268905|P2|Participant Flow|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
319667|NCT00268905|P1|Participant Flow|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
319668|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
321026|NCT00262600|P1|Participant Flow|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
319669|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
319670|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
319671|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
319672|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
319673|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
319674|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
319675|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
319676|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
319677|NCT00268905|E3|Reported Event|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
319678|NCT00268905|E2|Reported Event|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
319679|NCT00268905|E1|Reported Event|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
319680|NCT00268983|B3|Baseline|Total|Total of all reporting groups
319681|NCT00268983|B2|Baseline|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319682|NCT00268983|B1|Baseline|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319683|NCT00268983|P2|Participant Flow|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319684|NCT00268983|P1|Participant Flow|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319685|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319686|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319687|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319688|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
320316|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
319689|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319690|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319691|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319692|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319693|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319694|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319695|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319696|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319697|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
321027|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
319698|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319699|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319700|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319701|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319702|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319703|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319704|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319705|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319706|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319707|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319708|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319709|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319710|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319711|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319712|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319894|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319713|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319714|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319715|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319716|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319717|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319718|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319719|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319720|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319721|NCT00268983|E2|Reported Event|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;
Therapeutic dose, Given only once between Day 7 and Day 14:
450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
319722|NCT00268983|E1|Reported Event|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
319723|NCT00269113|B3|Baseline|Total|Total of all reporting groups
319724|NCT00269113|B2|Baseline|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319725|NCT00269113|B1|Baseline|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319726|NCT00269113|P2|Participant Flow|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319727|NCT00269113|P1|Participant Flow|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1 and 2, chlorambucil 3 times (x) 3 mg/m^2, by mouth (PO), every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a complete remission (CR) or partial remission (PR) following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with interferon (IFN) alpha 3 x 4.5 million international units (IU) per week, subcutaneously (SC), until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319772|NCT00269477|O2|Outcome|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
319773|NCT00269477|O1|Outcome|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
319728|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319729|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319730|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319731|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319763|NCT00269477|B3|Baseline|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
321017|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
319732|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319733|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319734|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319735|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
320028|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
319736|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319737|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319738|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319739|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319764|NCT00269477|B2|Baseline|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
319864|NCT00260689|E1|Reported Event|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
319865|NCT00260832|B3|Baseline|Total|Total of all reporting groups
319740|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319741|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319742|NCT00269113|E2|Reported Event|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319774|NCT00269477|O4|Outcome|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
319775|NCT00269477|O3|Outcome|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
320064|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
319743|NCT00269113|E1|Reported Event|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
319744|NCT00269152|B3|Baseline|Total|Total of all reporting groups
319745|NCT00269152|B2|Baseline|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
319746|NCT00269152|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
319747|NCT00269152|P2|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
319748|NCT00269152|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
319749|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
319750|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
319751|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
319752|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
319753|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
319754|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
319755|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
319756|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
319757|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
319758|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
319759|NCT00269152|E2|Reported Event|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
319760|NCT00269152|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
319761|NCT00269477|B5|Baseline|Total|Total of all reporting groups
319762|NCT00269477|B4|Baseline|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
319765|NCT00269477|B1|Baseline|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
319766|NCT00269477|P4|Participant Flow|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
319767|NCT00269477|P3|Participant Flow|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
319768|NCT00269477|P2|Participant Flow|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
319769|NCT00269477|P1|Participant Flow|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
319770|NCT00269477|O4|Outcome|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
319771|NCT00269477|O3|Outcome|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
320344|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
319776|NCT00269477|O2|Outcome|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
319777|NCT00269477|O1|Outcome|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
319778|NCT00269477|E4|Reported Event|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
319779|NCT00269477|E3|Reported Event|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
319780|NCT00269477|E2|Reported Event|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
319781|NCT00269477|E1|Reported Event|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
319782|NCT00260195|B3|Baseline|Total|Total of all reporting groups
319783|NCT00260195|B2|Baseline|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
319784|NCT00260195|B1|Baseline|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
319785|NCT00260195|P2|Participant Flow|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
319786|NCT00260195|P1|Participant Flow|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
319787|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
321018|NCT00262522|E2|Reported Event|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
319788|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
319789|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
319790|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
319791|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
319792|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
319793|NCT00260195|O2|Outcome|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
319794|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
319795|NCT00260195|E2|Reported Event|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
319796|NCT00260195|E1|Reported Event|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
319797|NCT00260208|B3|Baseline|Total|Total of all reporting groups
319798|NCT00260208|B2|Baseline|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319799|NCT00260208|B1|Baseline|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319876|NCT00260962|B1|Baseline|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
319800|NCT00260208|P2|Participant Flow|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319801|NCT00260208|P1|Participant Flow|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319802|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319803|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319804|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319805|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319806|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319861|NCT00260689|O1|Outcome|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
319862|NCT00260689|E3|Reported Event|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
319863|NCT00260689|E2|Reported Event|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
319807|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319808|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319809|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319810|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319811|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319812|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319892|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319813|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319814|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319815|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319816|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319817|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319818|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319819|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319820|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
321028|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
319821|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319822|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319823|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319824|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319825|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319826|NCT00260208|E2|Reported Event|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
319827|NCT00260208|E1|Reported Event|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
319828|NCT00260429|B3|Baseline|Total|Total of all reporting groups
319829|NCT00260429|B2|Baseline|Placebo|
319830|NCT00260429|B1|Baseline|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
319831|NCT00260429|P2|Participant Flow|Placebo|
319832|NCT00260429|P1|Participant Flow|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
319833|NCT00260429|O2|Outcome|Placebo|
319834|NCT00260429|O1|Outcome|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
319835|NCT00260429|E2|Reported Event|Placebo|
319836|NCT00260429|E1|Reported Event|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
319837|NCT00260533|B3|Baseline|Total|Total of all reporting groups
319838|NCT00260533|B2|Baseline|Placebo|Placebo
319839|NCT00260533|B1|Baseline|Atomoxetine|Atomoxetine
319840|NCT00260533|P2|Participant Flow|Placebo|Placebo (matched capsules to atomoxetine)
319841|NCT00260533|P1|Participant Flow|Atomoxetine|Atomoxetine 40-100 mg per day
319842|NCT00260533|O2|Outcome|Placebo|Placebo
319843|NCT00260533|O1|Outcome|Atomoxetine|Atomoxetine
319844|NCT00260533|E2|Reported Event|Placebo|Placebo
319845|NCT00260533|E1|Reported Event|Atomoxetine|Atomoxetine
319846|NCT00260689|B4|Baseline|Total|Total of all reporting groups
319847|NCT00260689|B3|Baseline|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
319848|NCT00260689|B2|Baseline|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
319849|NCT00260689|B1|Baseline|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
319850|NCT00260689|P3|Participant Flow|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
319851|NCT00260689|P2|Participant Flow|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
319852|NCT00260689|P1|Participant Flow|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
319853|NCT00260689|O3|Outcome|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
319854|NCT00260689|O2|Outcome|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
319855|NCT00260689|O1|Outcome|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
319856|NCT00260689|O3|Outcome|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
319857|NCT00260689|O2|Outcome|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
319858|NCT00260689|O1|Outcome|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
319859|NCT00260689|O3|Outcome|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
319860|NCT00260689|O2|Outcome|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
319866|NCT00260832|B2|Baseline|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
319867|NCT00260832|B1|Baseline|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
319868|NCT00260832|P2|Participant Flow|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
319869|NCT00260832|P1|Participant Flow|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
319870|NCT00260832|O2|Outcome|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
319871|NCT00260832|O1|Outcome|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
319872|NCT00260832|E2|Reported Event|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
319873|NCT00260832|E1|Reported Event|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
319874|NCT00260962|B3|Baseline|Total|Total of all reporting groups
319875|NCT00260962|B2|Baseline|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
320345|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
319877|NCT00260962|P2|Participant Flow|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
319878|NCT00260962|P1|Participant Flow|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
319879|NCT00260962|O2|Outcome|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
319880|NCT00260962|O1|Outcome|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
319881|NCT00260962|O2|Outcome|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
319910|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320044|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
319882|NCT00260962|O1|Outcome|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
319883|NCT00260962|E2|Reported Event|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
319884|NCT00260962|E1|Reported Event|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
319885|NCT00261443|B3|Baseline|Total|Total of all reporting groups
319886|NCT00261443|B2|Baseline|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319887|NCT00261443|B1|Baseline|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319888|NCT00261443|P3|Participant Flow|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
319889|NCT00261443|P2|Participant Flow|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
319890|NCT00261443|P1|Participant Flow|Pre-Randomized Participants|Phase 1 (2 to 8 Week Screening, Washout and Confirmation of Partial Nonresponse Phase): lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml. Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
319891|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320346|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
319895|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319896|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319897|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319898|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319899|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319900|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319901|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319902|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319903|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319904|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319905|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319906|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319907|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319908|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319909|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
328579|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
319911|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319912|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319913|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319914|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319915|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319916|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319917|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319918|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319919|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319920|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319921|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319922|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319923|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319924|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319925|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319926|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319927|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319928|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319929|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319930|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319931|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319932|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319933|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319934|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319935|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319936|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319937|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319938|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319939|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319940|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319941|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
319942|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
319943|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
321029|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
319944|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319945|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319946|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319947|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319948|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319949|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319950|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319951|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319952|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319953|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319954|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319955|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319956|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319957|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319958|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319959|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319960|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319961|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319962|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319963|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319964|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319965|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319966|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319967|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319968|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319969|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319970|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319971|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319972|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319973|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319974|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319975|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319976|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
328580|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
319977|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319978|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319979|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319980|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319981|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319982|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319983|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319984|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319985|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319986|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319987|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319988|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319989|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319990|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319991|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319992|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319993|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319994|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319995|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319996|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319997|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319998|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
319999|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320000|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320001|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320002|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320003|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320004|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320005|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320006|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320007|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320008|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320009|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
328581|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
320010|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320011|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320012|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320013|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320014|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320015|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320016|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320017|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320018|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320019|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320020|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320021|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320022|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320023|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320024|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320025|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320026|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320027|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320029|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320030|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320031|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320032|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320033|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320034|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320035|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320036|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320037|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320038|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320039|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320040|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320041|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320042|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320043|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
328582|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
320045|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320046|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320047|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320048|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320049|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320050|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320051|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320052|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320053|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320054|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320055|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320056|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320057|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320058|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320059|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320060|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320061|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320062|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320063|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320347|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320065|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320066|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320067|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320068|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320069|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320070|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320071|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320072|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320073|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320074|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320075|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320076|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320077|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320078|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320079|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320080|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320081|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320082|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320083|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320084|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320085|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320086|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320087|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320088|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320089|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320090|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320091|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320092|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320093|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320094|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320095|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320096|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320097|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320098|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320099|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320100|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320101|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320102|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320103|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320104|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320105|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320106|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320107|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320108|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320109|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320110|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320111|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320112|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320113|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
321030|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
320114|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320115|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320116|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320117|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320118|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320119|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320120|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320121|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320122|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320123|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320124|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320125|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320126|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320127|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320128|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320129|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
320130|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
320131|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320132|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320348|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320133|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320134|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320135|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320136|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320137|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320138|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
320139|NCT00261443|E5|Reported Event|Extension Phase Aripiprazole|Phase 4 (Extension Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
320140|NCT00261443|E4|Reported Event|Extension Phase Placebo|Phase 4 (Extension Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
320141|NCT00261443|E3|Reported Event|Double-Blind Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
320142|NCT00261443|E2|Reported Event|Double-Blind Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
320143|NCT00261443|E1|Reported Event|Single-Blind Aripiprazole|Phase 1 (2 to 8 Week Screening, Washout and Confirmation of Partial Nonresponse Phase): lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml. Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
320144|NCT00261495|B3|Baseline|Total|Total of all reporting groups
320145|NCT00261495|B2|Baseline|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320146|NCT00261495|B1|Baseline|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320369|NCT00261846|B6|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320147|NCT00261495|P2|Participant Flow|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320148|NCT00261495|P1|Participant Flow|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320149|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320150|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320151|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320152|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320153|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320154|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320155|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320156|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320157|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320158|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320159|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320160|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320161|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320162|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320163|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320349|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320164|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320165|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320166|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320167|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320168|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320169|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320170|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320171|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320172|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320173|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320174|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320175|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320176|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320177|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
328583|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
320178|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320179|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320180|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320181|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320182|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320183|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320184|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320185|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320186|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320187|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320188|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320189|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320190|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320191|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320192|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320193|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320194|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320195|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320196|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320197|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320198|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320199|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320200|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320201|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320202|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320203|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320204|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320205|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320206|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320207|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320208|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
328584|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
320209|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320210|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320211|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320212|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320213|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320214|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320215|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320216|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320217|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320218|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320219|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320220|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320221|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320222|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320223|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320224|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320225|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320226|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320227|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320228|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320229|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320230|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320231|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320232|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320233|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320234|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320235|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320236|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320237|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320238|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320239|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
328585|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
320240|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320241|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320242|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320243|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320244|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320245|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320246|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320247|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320248|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320249|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320250|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320251|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320252|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320253|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320254|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320255|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320256|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320257|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320258|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320259|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320260|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320261|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320262|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320263|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320264|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320265|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320266|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320267|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320268|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320269|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320270|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
328586|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
320271|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320272|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320273|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320274|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320275|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320276|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320277|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320278|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320279|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320280|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320281|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320282|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320283|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320284|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320285|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320286|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320287|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320288|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320289|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320290|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320291|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320292|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320293|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320294|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320295|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320296|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320297|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320298|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320299|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320300|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320301|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
328587|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
320302|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320303|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320304|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320305|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320306|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320307|NCT00261495|E2|Reported Event|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
320308|NCT00261495|E1|Reported Event|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
320309|NCT00261716|B3|Baseline|Total|Total of all reporting groups
320310|NCT00261716|B2|Baseline|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
320311|NCT00261716|B1|Baseline|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
320312|NCT00261716|P2|Participant Flow|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
320313|NCT00261716|P1|Participant Flow|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
320314|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
320317|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
320318|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
320319|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
320320|NCT00261716|O2|Outcome|IPS and IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching
IPS: Individual Placement and Support Evidence based supported employment
IE: Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
320321|NCT00261716|O1|Outcome|IPS and VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching
IPS: Individual Placement and Support Evidence based supported employment
VOMI: Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
320322|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
320323|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
320324|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
320370|NCT00261846|B5|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320325|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
320326|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
320327|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
320328|NCT00261716|E2|Reported Event|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
320329|NCT00261716|E1|Reported Event|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching
Individual Placement and Support (IPS): Evidence based supported employment
Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
320330|NCT00261833|B3|Baseline|Total|Total of all reporting groups
320331|NCT00261833|B2|Baseline|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320332|NCT00261833|B1|Baseline|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320333|NCT00261833|P2|Participant Flow|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320334|NCT00261833|P1|Participant Flow|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320335|NCT00261833|O2|Outcome|Placebo|Placebo: Lyophilized preparation: 60 mg/kg body weight/week intravenous
320336|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320337|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320338|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320339|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320340|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320341|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320342|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320343|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
321628|NCT00274469|E2|Reported Event|Anastrozole 1 mg|Anastrozole 1 mg
320352|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320353|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320354|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320355|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320356|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320357|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320358|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320359|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320360|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320361|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320362|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320363|NCT00261833|E2|Reported Event|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
320364|NCT00261833|E1|Reported Event|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
320365|NCT00261846|B10|Baseline|Total|Total of all reporting groups
320366|NCT00261846|B9|Baseline|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320367|NCT00261846|B8|Baseline|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
320368|NCT00261846|B7|Baseline|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
320371|NCT00261846|B4|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320372|NCT00261846|B3|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320373|NCT00261846|B2|Baseline|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320374|NCT00261846|B1|Baseline|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320375|NCT00261846|P12|Participant Flow|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320376|NCT00261846|P11|Participant Flow|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
320377|NCT00261846|P10|Participant Flow|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
320378|NCT00261846|P9|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320379|NCT00261846|P8|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320380|NCT00261846|P7|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320381|NCT00261846|P6|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320382|NCT00261846|P5|Participant Flow|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320383|NCT00261846|P4|Participant Flow|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320384|NCT00261846|P3|Participant Flow|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase (AP) CML Part 2 of the study.
320385|NCT00261846|P2|Participant Flow|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320386|NCT00261846|P1|Participant Flow|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line (CP2L) chronic myelogenous leukemia (CML) Part 2 of the study.
320387|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320388|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
320389|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
320390|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320391|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320392|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320393|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320394|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320395|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320396|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320397|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
320398|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
320399|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320400|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320401|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320402|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
321031|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
320403|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320404|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320405|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320406|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
320407|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320408|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
320409|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320410|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320411|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320412|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320413|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320414|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320415|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320416|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320417|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
320418|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
320419|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320420|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320421|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320422|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320423|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320424|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320425|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
321500|NCT00273793|O5|Outcome|Fixed Value Incentives Are Used in Smokers With Early Success|
320426|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
320427|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
320428|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320429|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320430|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320431|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320432|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320433|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320434|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320435|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
320436|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
320437|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320438|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320439|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320440|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320441|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320442|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320443|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320444|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
320445|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
320446|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320447|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320448|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320449|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320450|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320451|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320452|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320453|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
320454|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
320455|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320456|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320457|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320458|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320459|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320804|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320460|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320461|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320462|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
320463|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320464|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
320465|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320466|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320467|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320468|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320469|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320470|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
328588|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
320471|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320472|NCT00261846|O5|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320473|NCT00261846|O4|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
320474|NCT00261846|O3|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320475|NCT00261846|O2|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
320476|NCT00261846|O1|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320477|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320478|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
320479|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320480|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
320481|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320482|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320483|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320484|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320485|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320486|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320487|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320488|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320489|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
320490|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320491|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
320492|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320493|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320494|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320495|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320496|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320497|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320498|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320499|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320500|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
320501|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320502|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
320503|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
328589|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
320504|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320505|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320506|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320507|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320508|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320509|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320510|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320511|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
320512|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320513|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
320514|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320515|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320516|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320517|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320518|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320519|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320520|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320521|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320522|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
320523|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320524|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
320525|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320526|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320527|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320528|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320529|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320530|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320531|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320532|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320533|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
320534|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320535|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
320536|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
321019|NCT00262522|E1|Reported Event|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
320537|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320538|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320539|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320540|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320541|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320542|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320543|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320544|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
320545|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320546|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
320547|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320548|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320549|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320550|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320551|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320552|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320553|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320554|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320555|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
320556|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320557|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
320558|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320559|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320560|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320561|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320562|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320563|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320564|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320565|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320566|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320567|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320568|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
321020|NCT00262600|B4|Baseline|Total|Total of all reporting groups
320569|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320570|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320571|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320572|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
320573|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320574|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320575|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320576|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320577|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320578|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320579|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320580|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320581|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320582|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320583|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320584|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
321501|NCT00273793|O4|Outcome|Ascending Incentive Values Used in Smokers With Early Success|
320585|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320586|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320587|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320588|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320589|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320590|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320591|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320592|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320593|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320594|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320595|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320596|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320597|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320598|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320599|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320600|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320601|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320602|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320603|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320604|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320605|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320606|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320607|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320608|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320609|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320610|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320611|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320612|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320613|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320614|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320615|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320616|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320617|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320618|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320619|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320620|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320621|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320622|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320623|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320624|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320625|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320626|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320627|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320628|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320629|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320630|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
320631|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320632|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
320633|NCT00261846|E9|Reported Event|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
320634|NCT00261846|E8|Reported Event|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
320635|NCT00261846|E7|Reported Event|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
320636|NCT00261846|E6|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
320637|NCT00261846|E5|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
320638|NCT00261846|E4|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
321021|NCT00262600|B3|Baseline|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
320639|NCT00261846|E3|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
320640|NCT00261846|E2|Reported Event|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320641|NCT00261846|E1|Reported Event|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
320642|NCT00261950|B1|Baseline|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320643|NCT00261950|P1|Participant Flow|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320644|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320645|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320646|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320647|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320648|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320649|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320650|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320651|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320652|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320653|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320654|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320805|NCT00262028|O6|Outcome|MenACWY-PS (6-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
320655|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320656|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320657|NCT00261950|E1|Reported Event|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
320658|NCT00262002|B8|Baseline|Total|Total of all reporting groups
320659|NCT00262002|B7|Baseline|CA24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320660|NCT00262002|B6|Baseline|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320661|NCT00262002|B5|Baseline|CA24+ (MenACWY Ad+ at 2,4m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320662|NCT00262002|B4|Baseline|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320663|NCT00262002|B3|Baseline|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
321022|NCT00262600|B2|Baseline|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
320664|NCT00262002|B2|Baseline|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320665|NCT00262002|B1|Baseline|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320666|NCT00262002|P7|Participant Flow|CA24- (MenACWY Ad- at 2,4m)|"Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320667|NCT00262002|P6|Participant Flow|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320668|NCT00262002|P5|Participant Flow|CA24+ (MenACWY Ad+ at 2,4m)|"Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320669|NCT00262002|P4|Participant Flow|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320670|NCT00262002|P3|Participant Flow|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
320671|NCT00262002|P2|Participant Flow|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320672|NCT00262002|P1|Participant Flow|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320673|NCT00262002|O10|Outcome|CA24- (MenACWY Ad- at 2, 4 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320674|NCT00262002|O9|Outcome|CA24- (MenACWY Ad- at 2, 4 m) - ACWY|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320675|NCT00262002|O8|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320676|NCT00262002|O7|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320677|NCT00262002|O6|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m) - ACWY|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320678|NCT00262002|O5|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320679|NCT00262002|O4|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m) - No Treatment|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320680|NCT00262002|O3|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
320681|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320682|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320683|NCT00262002|O7|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320684|NCT00262002|O6|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320685|NCT00262002|O5|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
321023|NCT00262600|B1|Baseline|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
320686|NCT00262002|O4|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320687|NCT00262002|O3|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
320688|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320689|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320690|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320691|NCT00262002|O4|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320692|NCT00262002|O3|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320693|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320694|NCT00262002|O1|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
320695|NCT00262002|O6|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320696|NCT00262002|O5|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320697|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320698|NCT00262002|O3|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320806|NCT00262028|O5|Outcome|MenACWY-CRM (6-10 Years)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320699|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320700|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320701|NCT00262002|O6|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320702|NCT00262002|O5|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320703|NCT00262002|O4|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320704|NCT00262002|O3|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320705|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320706|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320725|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320707|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320708|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320709|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320710|NCT00262002|O3|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320711|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320712|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320713|NCT00262002|O2|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320714|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320715|NCT00262002|O2|Outcome|CA24- (MenACWY Ad- at 2, 4m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320716|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320717|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2, 4,6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320807|NCT00262028|O4|Outcome|MenACWY-PS (2-5 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
320718|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2,4,6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320719|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320720|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320721|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320722|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
320723|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320724|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320776|NCT00262028|P7|Participant Flow|MenACWY (16-23 Months)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
320726|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320727|NCT00262002|O1|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
320728|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320729|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad+ vaccine or one reduced dose ( of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320730|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320731|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320732|NCT00262002|O1|Outcome|UKMenC (Menjugate 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
320733|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320734|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320735|NCT00262002|O3|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320736|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320737|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320738|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320739|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320740|NCT00262002|O3|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320741|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320742|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320743|NCT00262002|O4|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320744|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320745|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320746|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320747|NCT00262002|O4|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320748|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
320775|NCT00262028|P8|Participant Flow|MenACWY+DTaP (16-23 Months)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) vaccine.
320749|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.
One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
320750|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
320751|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320752|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320753|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320754|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320755|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320756|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
320757|NCT00262002|E7|Reported Event|CA24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320758|NCT00262002|E6|Reported Event|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was to be given at 12 months of age.
320759|NCT00262002|E5|Reported Event|CA24+ (MenACWY Ad+ at 2,4m)|Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
320808|NCT00262028|O3|Outcome|MenACWY-CRM (2-5 Years)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320809|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
320760|NCT00262002|E4|Reported Event|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were to be given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was to be administered one dose of MMR (and Prevnar, if available) at 12 months of age.
320761|NCT00262002|E3|Reported Event|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate® were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
320762|NCT00262002|E2|Reported Event|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
320763|NCT00262002|E1|Reported Event|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were to be given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was to be given at 12 months of age.
320764|NCT00262028|B10|Baseline|Total|Total of all reporting groups
320765|NCT00262028|B9|Baseline|MenACWY+PS (3-5 YearsOld)|Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
320766|NCT00262028|B8|Baseline|MenACWY+DTaP (16-23 Months Old)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
320767|NCT00262028|B7|Baseline|MenACWY (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
320768|NCT00262028|B6|Baseline|MenACWY-PnC (12-15 Months Old)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
320769|NCT00262028|B5|Baseline|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
320770|NCT00262028|B4|Baseline|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
320771|NCT00262028|B3|Baseline|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320772|NCT00262028|B2|Baseline|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
320773|NCT00262028|B1|Baseline|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
320774|NCT00262028|P9|Participant Flow|MenACWY-PS (3-5 Years Old)|Children aged 3 to 5 years receiving MenACWY- polysaccharide (PS) vaccine from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
320777|NCT00262028|P6|Participant Flow|MenACWY+PnC (12-15 Months)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine (PnC).
320778|NCT00262028|P5|Participant Flow|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
320779|NCT00262028|P4|Participant Flow|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
320780|NCT00262028|P3|Participant Flow|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
320781|NCT00262028|P2|Participant Flow|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
320782|NCT00262028|P1|Participant Flow|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-cross-reactive material (CRM) conjugate vaccine.
320783|NCT00262028|O4|Outcome|MenACWY-CRM + DTaP (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with DTaP
320784|NCT00262028|O3|Outcome|MenACWY-CRM (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
320785|NCT00262028|O2|Outcome|MenACWY-CRM + PnC (12-15 Months Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with PnC
320786|NCT00262028|O1|Outcome|MenACWY-CRM (12-15 Months Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
320787|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
320788|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
320789|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
320790|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
320791|NCT00262028|O4|Outcome|MenACWY-CRM + DTaP (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with DTaP
320792|NCT00262028|O3|Outcome|MenACWY-CRM (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
320793|NCT00262028|O2|Outcome|MenACWY-CRM + PnC (12-15 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with PnC
320794|NCT00262028|O1|Outcome|MenACWY-CRM (12-15 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
320795|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
320796|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
320797|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
320798|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
320799|NCT00262028|O6|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
320800|NCT00262028|O5|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320801|NCT00262028|O4|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
320802|NCT00262028|O3|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320803|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
320810|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320811|NCT00262028|O2|Outcome|MenACWY-PS (3-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine This group was a subset of the Licensed comparator (2-5 year old) cohort that received one dose of licensed MenACWY-PS vaccine.
320812|NCT00262028|O1|Outcome|MenACWY-CRM (12-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320813|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of MenACWY-PS vaccine
320814|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of MenACWY-CRM conjugate vaccine
320815|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the MenACWY-PS vaccine
320816|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320817|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
320818|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320819|NCT00262028|O2|Outcome|MenACWY-PS (3-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine. This group was a subset of the licensed comparator (2-5 years old) cohort that received one dose of licensed MenACWY-PS vaccine
320820|NCT00262028|O1|Outcome|MenACWY-CRM (12-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320821|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
320822|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM vaccine
320823|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
320824|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
320827|NCT00262028|E9|Reported Event|MenACWY-PS (3-5 Years Old)|Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune not licensed in US in children under 2 years of ages) served as controls for the 12-23-months-old part two toddlers.
320828|NCT00262028|E8|Reported Event|MenACWY+DTaP (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
320829|NCT00262028|E7|Reported Event|MenACWY (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
320830|NCT00262028|E6|Reported Event|MenACWY-PnC (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
320831|NCT00262028|E5|Reported Event|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
320832|NCT00262028|E4|Reported Event|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-CRM polysaccharide vaccine.
320833|NCT00262028|E3|Reported Event|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
320834|NCT00262028|E2|Reported Event|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
320835|NCT00262028|E1|Reported Event|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
320836|NCT00262041|B5|Baseline|Total|Total of all reporting groups
320837|NCT00262041|B4|Baseline|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
320838|NCT00262041|B3|Baseline|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
320839|NCT00262041|B2|Baseline|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
320840|NCT00262041|B1|Baseline|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
320841|NCT00262041|P3|Participant Flow|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
320842|NCT00262041|P2|Participant Flow|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
320843|NCT00262041|P1|Participant Flow|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
320844|NCT00262041|O4|Outcome|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2)
320845|NCT00262041|O3|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
320846|NCT00262041|O2|Outcome|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1)
320847|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
320848|NCT00262041|O2|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
320849|NCT00262041|O1|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
320850|NCT00262041|O2|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
320851|NCT00262041|O1|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
320852|NCT00262041|O3|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
320853|NCT00262041|O2|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
320854|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
320855|NCT00262041|O3|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
320856|NCT00262041|O2|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
320857|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
320858|NCT00262041|E4|Reported Event|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
321502|NCT00273793|O3|Outcome|Non Contingent Incentives Available to Hard-to-Treat Smokers|
320859|NCT00262041|E3|Reported Event|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
320860|NCT00262041|E2|Reported Event|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
320861|NCT00262041|E1|Reported Event|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
320862|NCT00262067|B5|Baseline|Total|Total of all reporting groups
320863|NCT00262067|B4|Baseline|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320864|NCT00262067|B3|Baseline|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320865|NCT00262067|B2|Baseline|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320866|NCT00262067|B1|Baseline|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320867|NCT00262067|P4|Participant Flow|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320868|NCT00262067|P3|Participant Flow|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320869|NCT00262067|P2|Participant Flow|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
321024|NCT00262600|P3|Participant Flow|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
320870|NCT00262067|P1|Participant Flow|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320871|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320872|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320873|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320874|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320875|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320876|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320877|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320878|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320879|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320880|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320881|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320882|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320883|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320884|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320885|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320886|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320887|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320888|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
321629|NCT00274469|E1|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
320889|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320890|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320891|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320892|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320893|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320894|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320895|NCT00262067|E4|Reported Event|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320896|NCT00262067|E3|Reported Event|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
320897|NCT00262067|E2|Reported Event|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320938|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320898|NCT00262067|E1|Reported Event|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
320899|NCT00262080|B4|Baseline|Total|Total of all reporting groups
320900|NCT00262080|B3|Baseline|Ecallantide (Repeat-Dosing Part Only)|"Patients not treated in the double-blind part but treated with ecallantide in the repeat-dosing part.
One patient was omitted from analysis in the intent-to-treat and per-protocol populations due to the loss of the data for the 4-hour post-dose assessments during treatment episode 1."
320901|NCT00262080|B2|Baseline|Placebo / Ecallantide|Patients treated with placebo in the double-blind part (ITT as treated) and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
320902|NCT00262080|B1|Baseline|Ecallantide / Ecallantide|Patients treated with ecallantide in the double-blind part (ITT as treated) and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
320903|NCT00262080|P3|Participant Flow|Ecallantide (Repeat Dose Only)|Patients not treated in the double-blind part but treated with ecallantide in the repeat-dosing part.
320904|NCT00262080|P2|Participant Flow|Placebo / Ecallantide|Patients treated with placebo in the double-blind part and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
320905|NCT00262080|P1|Participant Flow|Ecallantide / Ecallantide|Patients treated with ecallantide in the double-blind part and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
320906|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
320907|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
320908|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
320909|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
320910|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
320911|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
320912|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
320913|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
320914|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
320915|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
320916|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
320917|NCT00262080|E3|Reported Event|Repeat-Dosing Ecallantide|All patients treated with ecallantide in the repeat-dosing part, regardless of whether they were treated previously in the double-blind part or not. All adverse events reported in all repeat-dosing episodes are included. Patients reporting more than 1 AE with the same preferred term are counted only once for that preferred term.
320918|NCT00262080|E2|Reported Event|Double-Blind Placebo|Patients treated with placebo in the double-blind part only.
320919|NCT00262080|E1|Reported Event|Double Blind - Ecallantide|Patients treated with ecallantide in the double-blind part only.
320920|NCT00262119|B4|Baseline|Total|Total of all reporting groups
320921|NCT00262119|B3|Baseline|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320922|NCT00262119|B2|Baseline|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320923|NCT00262119|B1|Baseline|Control Group|"PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320924|NCT00262119|P3|Participant Flow|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320925|NCT00262119|P2|Participant Flow|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320926|NCT00262119|P1|Participant Flow|Control Group|"PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320927|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320928|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320929|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320930|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320931|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320932|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320933|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320934|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320935|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320936|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320937|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320939|NCT00262119|E3|Reported Event|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320940|NCT00262119|E2|Reported Event|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320941|NCT00262119|E1|Reported Event|Control Group|"PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
320942|NCT00262223|B3|Baseline|Total|Total of all reporting groups
320943|NCT00262223|B2|Baseline|2) Seeking Safety + Placebo|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill placebo
320944|NCT00262223|B1|Baseline|1) Seeking Safety + Sertraline|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
320945|NCT00262223|P2|Participant Flow|2) Seeking Safety + Placebo|"Seeking Safety + Placebo;
Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type"
320946|NCT00262223|P1|Participant Flow|1) Seeking Safety + Sertraline|"Seeking Safety + Sertraline
Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type"
320947|NCT00262223|O2|Outcome|2) Seeking Safety + Placebo|Seeking Safety + Placebo;
320948|NCT00262223|O1|Outcome|1) Seeking Safety + Sertraline|Seeking Safety + Sertraline
320949|NCT00262223|O2|Outcome|2) Seeking Safety + Placebo|Seeking Safety + Placebo
320950|NCT00262223|O1|Outcome|1) Seeking Safety + Sertraline|Seeking Safety + Sertraline
320951|NCT00262223|E2|Reported Event|Seeking Seeking + Placebo|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill Placebo
320952|NCT00262223|E1|Reported Event|Seeking Safety + Sertraline|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders, + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
320953|NCT00262301|B4|Baseline|Total|Total of all reporting groups
320954|NCT00262301|B3|Baseline|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
320955|NCT00262301|B2|Baseline|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
320956|NCT00262301|B1|Baseline|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
320957|NCT00262301|P3|Participant Flow|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received, 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase. Patients received 1 vial initially and could receive an additional 1-2 vials within 4 hours at the investigator's discretion."
320958|NCT00262301|P2|Participant Flow|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
320959|NCT00262301|P1|Participant Flow|"100 IU/kg rhC1INH"|Includes all subjects randomized and who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
320960|NCT00262301|O3|Outcome|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
320961|NCT00262301|O2|Outcome|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
320962|NCT00262301|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
320963|NCT00262301|O3|Outcome|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
320964|NCT00262301|O2|Outcome|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
320965|NCT00262301|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
320966|NCT00262301|E3|Reported Event|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
320967|NCT00262301|E2|Reported Event|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
320968|NCT00262301|E1|Reported Event|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
320969|NCT00262314|B1|Baseline|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320970|NCT00262314|P1|Participant Flow|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320971|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320972|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320973|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320974|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320975|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320976|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320977|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320978|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320979|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320980|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320981|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320982|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320983|NCT00262314|E1|Reported Event|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
320984|NCT00262509|B3|Baseline|Total|Total of all reporting groups
320985|NCT00262509|B2|Baseline|First Intervention, Then Baseline|"Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes.
Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes."
320986|NCT00262509|B1|Baseline|First Baseline, Then Intervention|"Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes.
Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes."
320987|NCT00262509|P2|Participant Flow|Intervention First, Then Baseline|"Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes.
Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes."
320988|NCT00262509|P1|Participant Flow|Baseline First, Then Intervention|"Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes.
Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes."
320989|NCT00262509|O2|Outcome|Baseline|All Blind Participants, in two separate trials, are walked into a building to a specific location, and then are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is calculated as the average of the trial times.
320990|NCT00262509|O1|Outcome|Intervention|All Blind Participants are trained for 15 minutes in the use of the egress device, then for two separate trials are walked into a building to a specific location, and are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is obtained by averaging the two trial times
320991|NCT00262509|E2|Reported Event|Baseline Egress|Blind subjects are walked into a building to different locations in two separate trials and then asked to find their way out of the building.
320992|NCT00262509|E1|Reported Event|Egress Badge Intervention|Blind Participants are trained for 15 minutes in the use of the egress badge, then for two separate trials they are walked into a building to a different locations, and are asked to find their way out of the building.
320993|NCT00262522|B5|Baseline|Total|Total of all reporting groups
320994|NCT00262522|B4|Baseline|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
320995|NCT00262522|B3|Baseline|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
320996|NCT00262522|B2|Baseline|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
320997|NCT00262522|B1|Baseline|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
320998|NCT00262522|P4|Participant Flow|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
320999|NCT00262522|P3|Participant Flow|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
321000|NCT00262522|P2|Participant Flow|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
321001|NCT00262522|P1|Participant Flow|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
321002|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
321003|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
321004|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
321005|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
321006|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
321007|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
321008|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
321009|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
321010|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
321011|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
321012|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
321013|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
321014|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
321015|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
321016|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
321032|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
321033|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
321034|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
321035|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
321036|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
321037|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
321038|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
321039|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
321040|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
321041|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
321042|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
321043|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
321044|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
321045|NCT00262600|E3|Reported Event|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
321046|NCT00262600|E2|Reported Event|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
321047|NCT00262600|E1|Reported Event|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
321048|NCT00262639|B5|Baseline|Total|Total of all reporting groups
321049|NCT00262639|B4|Baseline|High CIWAar Flumazenil/Gabapentin|
321050|NCT00262639|B3|Baseline|High CIWAar Placebo|
321051|NCT00262639|B2|Baseline|Low CIWAar Flumazenil/Gabapentin|
321052|NCT00262639|B1|Baseline|Low CIWAar Placebo|
321053|NCT00262639|P4|Participant Flow|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
321054|NCT00262639|P3|Participant Flow|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
321055|NCT00262639|P2|Participant Flow|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
321056|NCT00262639|P1|Participant Flow|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
321057|NCT00262639|O4|Outcome|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
321058|NCT00262639|O3|Outcome|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
321059|NCT00262639|O2|Outcome|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
321060|NCT00262639|O1|Outcome|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
321061|NCT00262639|O4|Outcome|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
321503|NCT00273793|O2|Outcome|Fixed Criterion Intervention for Hard-to-Treat Smokers|
321062|NCT00262639|O3|Outcome|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
321063|NCT00262639|O2|Outcome|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
321064|NCT00262639|O1|Outcome|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
321065|NCT00262639|E4|Reported Event|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
321066|NCT00262639|E3|Reported Event|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
321067|NCT00262639|E2|Reported Event|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
321068|NCT00262639|E1|Reported Event|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
321069|NCT00269633|B3|Baseline|Total|Total of all reporting groups
321070|NCT00269633|B2|Baseline|Blue Light Box|"467 nm
Blue Light Box: 467 nm Blue LED Light"
321071|NCT00269633|B1|Baseline|Red Light Box|"657 nm
Red Light Box: 657 nm Red LED Light"
321072|NCT00269633|P2|Participant Flow|Blue Light Box 467 nm|LED Blue Light Box 467 nm
321073|NCT00269633|P1|Participant Flow|Red Light Box 657 nm|LED Red Light Box 657 nm
321074|NCT00269633|O2|Outcome|Blue Light Box 467 nm|LED Blue Light Box 467 nm
321075|NCT00269633|O1|Outcome|Red Light Box 657 nm|LED Red Light Box 657 nm
321076|NCT00269633|E2|Reported Event|Blue Light Box|"467 nm
Blue Light Box: 467 nm Blue LED Light"
321077|NCT00269633|E1|Reported Event|Red Light Box|Red Light Box: 657 nm Blue LED Light
321078|NCT00269919|B1|Baseline|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321079|NCT00269919|P1|Participant Flow|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly (into a muscle) depending on Investigator’s discretion every 2 weeks for 2 years.
321080|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321081|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321082|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg had been administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321083|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321084|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321085|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321086|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321087|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321088|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321089|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321090|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321091|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321092|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321093|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321094|NCT00269919|E1|Reported Event|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
321095|NCT00272779|B3|Baseline|Total|Total of all reporting groups
321096|NCT00272779|B2|Baseline|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321630|NCT00274625|B3|Baseline|Total|Total of all reporting groups
321097|NCT00272779|B1|Baseline|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321098|NCT00272779|P2|Participant Flow|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321099|NCT00272779|P1|Participant Flow|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321100|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321101|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321102|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321318|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321429|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321103|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321104|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321105|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321106|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321107|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321108|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321109|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321110|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321111|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321112|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321113|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321114|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321308|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321504|NCT00273793|O1|Outcome|Shaping Intervention for Hard-to-Treat Smokers|
321115|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321116|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321117|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321118|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321119|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321120|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321121|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321430|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
328590|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
321122|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321123|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321124|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321125|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321126|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321127|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321128|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321129|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321130|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321131|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321132|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321133|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321134|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321135|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321136|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321137|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321138|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321139|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321140|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321431|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321141|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321142|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321143|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321144|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321145|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321146|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321147|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321148|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321149|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321150|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321151|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321152|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321153|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321154|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321155|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321156|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321157|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321158|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321159|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321432|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
328591|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
321160|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321161|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321162|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321163|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321164|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321165|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321166|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321167|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321168|NCT00272779|O1|Outcome|All Participants With Pharmacogenetic Blood Samples|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321169|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321170|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321171|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321172|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321173|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321174|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321175|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321176|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321177|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321178|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321341|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321179|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321180|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321181|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321182|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321183|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321184|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321185|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321186|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321187|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321188|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321189|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321332|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321190|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321191|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321192|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321193|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321194|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321195|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321196|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321197|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321420|NCT00273052|B1|Baseline|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321198|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321199|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321200|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321201|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321202|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321203|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321204|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321205|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321206|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321207|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321208|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
323675|NCT00283439|B5|Baseline|Total|Total of all reporting groups
321209|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321210|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321211|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321212|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321213|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321214|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321215|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321216|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321421|NCT00273052|P2|Participant Flow|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321639|NCT00274651|B3|Baseline|Total|Total of all reporting groups
321217|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321218|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321219|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321220|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321221|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321222|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321223|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321224|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321225|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321226|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321246|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321227|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321228|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321229|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321230|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321231|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321232|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321233|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321234|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321235|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321422|NCT00273052|P1|Participant Flow|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321236|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321237|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321238|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321239|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321240|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321241|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321242|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321243|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321244|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321245|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321247|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321248|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321249|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321250|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321251|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321252|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321253|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321254|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321423|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
328592|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
321255|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321256|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321257|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321258|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321259|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321260|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321261|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321262|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321263|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321264|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321284|NCT00272792|O2|Outcome|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
321265|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321266|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321267|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321268|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321269|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321270|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321271|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321272|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321273|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321424|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321274|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321275|NCT00272779|E2|Reported Event|LPV/RTV/Tenofovir/Emtricitabine|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
321276|NCT00272779|E1|Reported Event|ATV/RTV/Tenofovir/Emtricitabine|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
321277|NCT00272792|B3|Baseline|Total|Total of all reporting groups
321278|NCT00272792|B2|Baseline|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
321279|NCT00272792|B1|Baseline|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
321280|NCT00272792|P2|Participant Flow|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
321281|NCT00272792|P1|Participant Flow|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
321282|NCT00272792|O2|Outcome|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
321283|NCT00272792|O1|Outcome|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
321307|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321285|NCT00272792|O1|Outcome|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
321286|NCT00272792|E2|Reported Event|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
321287|NCT00272792|E1|Reported Event|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
321288|NCT00272961|B6|Baseline|Total|Total of all reporting groups
321289|NCT00272961|B5|Baseline|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321290|NCT00272961|B4|Baseline|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321291|NCT00272961|B3|Baseline|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321292|NCT00272961|B2|Baseline|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321293|NCT00272961|B1|Baseline|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321294|NCT00272961|P5|Participant Flow|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
328593|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
321295|NCT00272961|P4|Participant Flow|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321296|NCT00272961|P3|Participant Flow|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321297|NCT00272961|P2|Participant Flow|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321298|NCT00272961|P1|Participant Flow|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321299|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321300|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321301|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321302|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321303|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321304|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321305|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321306|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321309|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321310|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321311|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321312|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321313|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321314|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321315|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321316|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321317|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
328594|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
321319|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321320|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321321|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321322|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321323|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321324|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321325|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321326|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321327|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321328|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321329|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321330|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321331|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321333|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321334|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321335|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321336|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321337|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321338|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321339|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321340|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321425|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321342|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321343|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321344|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321345|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321346|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321347|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321348|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321349|NCT00272961|E5|Reported Event|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
321350|NCT00272961|E4|Reported Event|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
321351|NCT00272961|E3|Reported Event|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321352|NCT00272961|E2|Reported Event|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
321353|NCT00272961|E1|Reported Event|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
321354|NCT00272987|B4|Baseline|Total|Total of all reporting groups
321355|NCT00272987|B3|Baseline|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321453|NCT00273182|B1|Baseline|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
321356|NCT00272987|B2|Baseline|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321357|NCT00272987|B1|Baseline|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321358|NCT00272987|P3|Participant Flow|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321359|NCT00272987|P2|Participant Flow|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321360|NCT00272987|P1|Participant Flow|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321361|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321362|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321363|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321364|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321365|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321366|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321367|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321368|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321369|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321611|NCT00274456|E2|Reported Event|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
323816|NCT00283842|B6|Baseline|Total|Total of all reporting groups
321370|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321371|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321372|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321373|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321374|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321375|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321426|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
322518|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
321376|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321377|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321378|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321379|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321380|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321381|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321382|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321454|NCT00273182|P1|Participant Flow|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
323817|NCT00283842|B5|Baseline|Placebo|
321383|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321384|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321385|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321386|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321387|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321388|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321389|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321427|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321390|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321391|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321392|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321393|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321394|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321395|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321396|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321617|NCT00274469|P1|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
321397|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321398|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321399|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321400|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321401|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321402|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321403|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321428|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
322519|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
321404|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321405|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321406|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321407|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321408|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321409|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321455|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
321618|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
321410|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321411|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321412|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321413|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321414|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321415|NCT00272987|E3|Reported Event|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
321416|NCT00272987|E2|Reported Event|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
321417|NCT00272987|E1|Reported Event|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
321418|NCT00273052|B3|Baseline|Total|Total of all reporting groups
321419|NCT00273052|B2|Baseline|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321433|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321434|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321435|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321436|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321437|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321438|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321439|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321440|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321441|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321442|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321443|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321444|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321445|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321446|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321447|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321448|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321449|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
321450|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
321451|NCT00273052|E2|Reported Event|Toprol XL|Results include only treatment emergent events.
321452|NCT00273052|E1|Reported Event|Coreg CR|Results include only treatment emergent events.
321498|NCT00273793|O1|Outcome|Shaping Intervention for Hard-to-Treat Smokers|
321499|NCT00273793|O6|Outcome|Non Contingent Incentives Are Available to Smokers With Early|
321619|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
321456|NCT00273182|O1|Outcome|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
321457|NCT00273182|O1|Outcome|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
321458|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
321459|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
321460|NCT00273182|E1|Reported Event|All Patients|The analysis included data from all subjects enrolled in the InSync Registry study.
321461|NCT00273754|B3|Baseline|Total|Total of all reporting groups
321462|NCT00273754|B2|Baseline|Caffeine|Caffeine benzoate
321463|NCT00273754|B1|Baseline|Placebo|Normal Saline
321464|NCT00273754|P2|Participant Flow|Caffeine|Caffeine benzoate
321465|NCT00273754|P1|Participant Flow|Placebo|Normal Saline
321466|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
321467|NCT00273754|O1|Outcome|Placebo|Normal Saline
321468|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
321469|NCT00273754|O1|Outcome|Placebo|Normal Saline
321470|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
321471|NCT00273754|O1|Outcome|Placebo|Normal Saline
321472|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
321473|NCT00273754|O1|Outcome|Placebo|Normal Saline
321474|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
321475|NCT00273754|O1|Outcome|Placebo|Normal Saline
321476|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
321477|NCT00273754|O1|Outcome|Placebo|Normal Saline
321478|NCT00273754|E2|Reported Event|Caffeine|Caffeine benzoate
321479|NCT00273754|E1|Reported Event|Placebo|Normal Saline
321480|NCT00273793|B7|Baseline|Total|Total of all reporting groups
321481|NCT00273793|B6|Baseline|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
321482|NCT00273793|B5|Baseline|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
321483|NCT00273793|B4|Baseline|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
321484|NCT00273793|B3|Baseline|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
321485|NCT00273793|B2|Baseline|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
321486|NCT00273793|B1|Baseline|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
321487|NCT00273793|P6|Participant Flow|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
321488|NCT00273793|P5|Participant Flow|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
321489|NCT00273793|P4|Participant Flow|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
321490|NCT00273793|P3|Participant Flow|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
321491|NCT00273793|P2|Participant Flow|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
321492|NCT00273793|P1|Participant Flow|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
321493|NCT00273793|O6|Outcome|Non Contingent Incentives Are Available to Smokers With Early|
321494|NCT00273793|O5|Outcome|Fixed Value Incentives Are Used in Smokers With Early Success|
321495|NCT00273793|O4|Outcome|Ascending Incentive Values Used in Smokers With Early Success|
321496|NCT00273793|O3|Outcome|Non Contingent Incentives Available to Hard-to-Treat Smokers|
321497|NCT00273793|O2|Outcome|Fixed Criterion Intervention for Hard-to-Treat Smokers|
321505|NCT00273793|E6|Reported Event|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
321506|NCT00273793|E5|Reported Event|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
321507|NCT00273793|E4|Reported Event|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
321508|NCT00273793|E3|Reported Event|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
321509|NCT00273793|E2|Reported Event|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
321510|NCT00273793|E1|Reported Event|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
321511|NCT00273858|B1|Baseline|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
321512|NCT00273858|P1|Participant Flow|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
321513|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
321514|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
321515|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
321516|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
321517|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
321518|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
321519|NCT00273858|E1|Reported Event|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
321520|NCT00273910|B7|Baseline|Total|Total of all reporting groups
321521|NCT00273910|B6|Baseline|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
321522|NCT00273910|B5|Baseline|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321523|NCT00273910|B4|Baseline|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
321524|NCT00273910|B3|Baseline|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321525|NCT00273910|B2|Baseline|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
321526|NCT00273910|B1|Baseline|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321527|NCT00273910|P6|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
321528|NCT00273910|P5|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321529|NCT00273910|P4|Participant Flow|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
321530|NCT00273910|P3|Participant Flow|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321531|NCT00273910|P2|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
321532|NCT00273910|P1|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321612|NCT00274456|E1|Reported Event|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321533|NCT00273910|O6|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
321534|NCT00273910|O5|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321535|NCT00273910|O4|Outcome|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
321536|NCT00273910|O3|Outcome|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321537|NCT00273910|O2|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
321538|NCT00273910|O1|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321539|NCT00273910|O6|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
321540|NCT00273910|O5|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321541|NCT00273910|O4|Outcome|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
322520|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
321542|NCT00273910|O3|Outcome|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321543|NCT00273910|O2|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
321544|NCT00273910|O1|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321545|NCT00273910|E6|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
321546|NCT00273910|E5|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321547|NCT00273910|E4|Reported Event|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
321548|NCT00273910|E3|Reported Event|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321549|NCT00273910|E2|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
321550|NCT00273910|E1|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
321551|NCT00274261|B3|Baseline|Total|Total of all reporting groups
321552|NCT00274261|B2|Baseline|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
321553|NCT00274261|B1|Baseline|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
321554|NCT00274261|P2|Participant Flow|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
321555|NCT00274261|P1|Participant Flow|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
321556|NCT00274261|O2|Outcome|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
321557|NCT00274261|O1|Outcome|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
321558|NCT00274261|E2|Reported Event|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
321559|NCT00274261|E1|Reported Event|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
321560|NCT00274287|B1|Baseline|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
321613|NCT00274469|B3|Baseline|Total|Total of all reporting groups
321614|NCT00274469|B2|Baseline|Anastrozole 1 mg|Anastrozole 1 mg
321615|NCT00274469|B1|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
321561|NCT00274287|P1|Participant Flow|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
321562|NCT00274287|O1|Outcome|GM-CSF (Leukine)|Taxotere is given at 75 mg/m2 on day 1 intravenously over 60 minutes with appropriate and standard pre-medications. Patients are eligible to receive growth factor support with G-CSF or Neulasta on day 2 at the investigator's discretion.
321563|NCT00274287|E1|Reported Event|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
321564|NCT00274456|B5|Baseline|Total|Total of all reporting groups
321565|NCT00274456|B4|Baseline|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321566|NCT00274456|B3|Baseline|ABI-007 150 mg/m^2|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest.
321567|NCT00274456|B2|Baseline|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321568|NCT00274456|B1|Baseline|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321569|NCT00274456|P4|Participant Flow|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321570|NCT00274456|P3|Participant Flow|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321571|NCT00274456|P2|Participant Flow|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321572|NCT00274456|P1|Participant Flow|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321573|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321574|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321575|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321576|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321577|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321578|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321579|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
328595|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
321580|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321581|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321582|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321583|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321584|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321585|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321586|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321587|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321588|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321589|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321590|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321591|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321592|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321593|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321594|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321595|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321596|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321597|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321598|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321599|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321600|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321601|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321602|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321603|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321604|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321605|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321606|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321607|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321608|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
321609|NCT00274456|E4|Reported Event|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
321610|NCT00274456|E3|Reported Event|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
321631|NCT00274625|B2|Baseline|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
321632|NCT00274625|B1|Baseline|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
321633|NCT00274625|P2|Participant Flow|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
321634|NCT00274625|P1|Participant Flow|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
321635|NCT00274625|O2|Outcome|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
321636|NCT00274625|O1|Outcome|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
321637|NCT00274625|E2|Reported Event|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
321638|NCT00274625|E1|Reported Event|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
321640|NCT00274651|B2|Baseline|PTCL (ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321641|NCT00274651|B1|Baseline|CTCL (ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321642|NCT00274651|P2|Participant Flow|Arm B (PTCL, ITT Population)|PXD101 1000 mg/m2 once daily for 5 days every 21 days
321643|NCT00274651|P1|Participant Flow|Arm A (CTCL, ITT Population)|PXD101 1000 mg/m2 once daily for 5 days every 21 days
321644|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321645|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321646|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321647|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321648|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321649|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321650|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321651|NCT00274651|O1|Outcome|PTCL (ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321652|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321653|NCT00274651|E2|Reported Event|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321654|NCT00274651|E1|Reported Event|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV
belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
321655|NCT00274716|B7|Baseline|Total|Total of all reporting groups
321656|NCT00274716|B6|Baseline|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321657|NCT00274716|B5|Baseline|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321658|NCT00274716|B4|Baseline|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321659|NCT00274716|B3|Baseline|High BMI:MK-0916 6mg→MK-0916 6mg|Participants who received MK-0916 6 mg in Phase A and continued on MK-0916 6 mg for 12 weeks in Phase B
321660|NCT00274716|B2|Baseline|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321661|NCT00274716|B1|Baseline|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321662|NCT00274716|P6|Participant Flow|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321663|NCT00274716|P5|Participant Flow|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321664|NCT00274716|P4|Participant Flow|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321665|NCT00274716|P3|Participant Flow|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321666|NCT00274716|P2|Participant Flow|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321667|NCT00274716|P1|Participant Flow|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321668|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321669|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321670|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321671|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321672|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321673|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321674|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321675|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321676|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321677|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321678|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321679|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321680|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
328596|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
321681|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321682|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321683|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321684|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321685|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321686|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321687|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321688|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321689|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321690|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321691|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321692|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
321693|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
321694|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
321695|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
321696|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
321697|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
321698|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
321699|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
321700|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
321701|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
321702|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
321703|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
321704|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
321705|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
321706|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
321707|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
321708|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
321709|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
321710|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
321711|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
321712|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
321713|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
321714|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
321715|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
321716|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
321717|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
321718|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
321719|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
321720|NCT00274716|E6|Reported Event|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321721|NCT00274716|E5|Reported Event|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321722|NCT00274716|E4|Reported Event|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321723|NCT00274716|E3|Reported Event|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
321724|NCT00274716|E2|Reported Event|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321725|NCT00274716|E1|Reported Event|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
321726|NCT00274742|B7|Baseline|Total|Total of all reporting groups
321727|NCT00274742|B6|Baseline|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321728|NCT00274742|B5|Baseline|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
321729|NCT00274742|B4|Baseline|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321730|NCT00274742|B3|Baseline|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321731|NCT00274742|B2|Baseline|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321732|NCT00274742|B1|Baseline|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321733|NCT00274742|P6|Participant Flow|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321734|NCT00274742|P5|Participant Flow|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
321735|NCT00274742|P4|Participant Flow|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321736|NCT00274742|P3|Participant Flow|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321737|NCT00274742|P2|Participant Flow|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321738|NCT00274742|P1|Participant Flow|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321739|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321740|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
321741|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321742|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321743|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321744|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321745|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321746|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
321747|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321748|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321749|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321750|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321751|NCT00274742|O5|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
321752|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d|Participants received blinatumomab 60 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
321753|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion in hte first treatment cycle.
321754|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants who received blinatumomab 15 µg/m²/day as continuous intravenous infusion in the first treatment cyle.
321755|NCT00274742|O1|Outcome|Blinatumomab 5 µg/m²/d|Participants who received blinatumomab 5 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
322003|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
321756|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321757|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
321758|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321759|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321760|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321761|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321762|NCT00274742|E7|Reported Event|Blinatumomab Overall|All participants who received any dose of blinatumomab
321763|NCT00274742|E6|Reported Event|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321764|NCT00274742|E5|Reported Event|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
321765|NCT00274742|E4|Reported Event|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321766|NCT00274742|E3|Reported Event|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321767|NCT00274742|E2|Reported Event|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321768|NCT00274742|E1|Reported Event|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
321769|NCT00274768|B1|Baseline|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
321770|NCT00274768|P1|Participant Flow|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
321771|NCT00274768|O1|Outcome|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
321772|NCT00274768|E1|Reported Event|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
321773|NCT00274781|B1|Baseline|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
321774|NCT00274781|P1|Participant Flow|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
321775|NCT00274781|O1|Outcome|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
321776|NCT00274781|O1|Outcome|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
321777|NCT00274781|O1|Outcome|ATO + GO|"Arsenic Trioxide 0.25 mg/kg D1-5 Week 1/Twice Weekly W2-12 + Gemtuzumab Ozogamicin 3 mg/m^2 D8 for 1 or 2 Cycles of 12 Weeks each
arsenic trioxide: Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12).
gemtuzumab ozogamicin: Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion"
321778|NCT00274781|E1|Reported Event|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
321779|NCT00274846|B1|Baseline|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
321780|NCT00274846|P1|Participant Flow|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
321781|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
321782|NCT00274846|O1|Outcome|Patients Achieving Complete Remission - Responders|Patients who achieved complete remission (CR) as judged by morphological criteria; only these patients can be judged for time to relapse.
321783|NCT00274846|O1|Outcome|Patients Achieving Complete Remission - Responders|Patients who achieved complete remission (CR) as judged by morphological criteria; only these patients can be judged for time to relapse.
321784|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
321785|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
321786|NCT00274846|E1|Reported Event|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
321787|NCT00265616|B3|Baseline|Total|Total of all reporting groups
321788|NCT00265616|B2|Baseline|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321789|NCT00265616|B1|Baseline|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321790|NCT00265616|P2|Participant Flow|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG); no maximum doses defined.
321791|NCT00265616|P1|Participant Flow|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG);no maximum doses defined.
321792|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321793|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321794|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321795|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321796|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321797|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321798|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321799|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321800|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321801|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321802|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321803|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321804|NCT00265616|E2|Reported Event|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321805|NCT00265616|E1|Reported Event|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
321806|NCT00265759|B7|Baseline|Total|Total of all reporting groups
321807|NCT00265759|B6|Baseline|Cohort B Arm III: Week 2 Ki67 No Invasive Disease Present|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
321808|NCT00265759|B5|Baseline|Cohort B Arm II: Week 2 Ki67 >10%|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
321809|NCT00265759|B4|Baseline|Cohort B Arm I: Week 2 Ki67 <=10%|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
321810|NCT00265759|B3|Baseline|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321811|NCT00265759|B2|Baseline|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321812|NCT00265759|B1|Baseline|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321813|NCT00265759|P4|Participant Flow|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
321814|NCT00265759|P3|Participant Flow|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
322383|NCT00266825|E3|Reported Event|DHA Capsule - Mother|"DHA capsule
DHA: 600 mg DHA"
321815|NCT00265759|P2|Participant Flow|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
321816|NCT00265759|P1|Participant Flow|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
321817|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321818|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321819|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321934|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
328597|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
321820|NCT00265759|O1|Outcome|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
321821|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321822|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321823|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321824|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321825|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321826|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321827|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321828|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321829|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321830|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321831|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321832|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321833|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321834|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321835|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321836|NCT00265759|O1|Outcome|Cohort B Arm II: Week 2 Ki67 > 10%|Patients who after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy had a tumor Ki67 level of greater than 10% and switched to neoadjuvant chemotherapy.
321837|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321838|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321839|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321840|NCT00265759|E4|Reported Event|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
324079|NCT00285207|O2|Outcome|A007|Experimental A007
321841|NCT00265759|E3|Reported Event|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321842|NCT00265759|E2|Reported Event|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321843|NCT00265759|E1|Reported Event|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
321844|NCT00265785|B1|Baseline|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
321845|NCT00265785|P1|Participant Flow|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
322021|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
321846|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
321847|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
321848|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
321849|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
321850|NCT00265785|E1|Reported Event|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
321851|NCT00265798|B1|Baseline|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
321852|NCT00265798|P1|Participant Flow|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
321853|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
321854|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
321855|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
321856|NCT00265798|E1|Reported Event|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
321857|NCT00265850|B4|Baseline|Total|Total of all reporting groups
321858|NCT00265850|B3|Baseline|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321859|NCT00265850|B2|Baseline|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321882|NCT00266032|P3|Participant Flow|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
321925|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321860|NCT00265850|B1|Baseline|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321861|NCT00265850|P3|Participant Flow|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321935|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321936|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321862|NCT00265850|P2|Participant Flow|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321863|NCT00265850|P1|Participant Flow|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321864|NCT00265850|O3|Outcome|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321865|NCT00265850|O2|Outcome|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321866|NCT00265850|O1|Outcome|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321883|NCT00266032|P2|Participant Flow|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
321926|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
323058|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
321867|NCT00265850|O3|Outcome|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321868|NCT00265850|O2|Outcome|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321869|NCT00265850|O1|Outcome|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321937|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
322022|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322023|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
321870|NCT00265850|E2|Reported Event|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321871|NCT00265850|E1|Reported Event|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
321872|NCT00265889|B1|Baseline|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
321873|NCT00265889|P1|Participant Flow|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
321874|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
321875|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
321876|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
321877|NCT00265889|E1|Reported Event|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
321878|NCT00266032|B4|Baseline|Total|Total of all reporting groups
321879|NCT00266032|B3|Baseline|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
321880|NCT00266032|B2|Baseline|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
321881|NCT00266032|B1|Baseline|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321923|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321884|NCT00266032|P1|Participant Flow|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321885|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321886|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321887|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
322024|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322025|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
321888|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321889|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
321890|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
321891|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321892|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
321893|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
321894|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321895|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
321896|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
321924|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
322000|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
321897|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321898|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
321899|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
321900|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321901|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321938|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321902|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321903|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321904|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321905|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
321906|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
321907|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321908|NCT00266032|E3|Reported Event|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
321909|NCT00266032|E2|Reported Event|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
323059|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
321910|NCT00266032|E1|Reported Event|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
321911|NCT00266110|B1|Baseline|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion
sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.
therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.
trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
321912|NCT00266110|P1|Participant Flow|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion
Sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.
Therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed dendritic cells (DCs) given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.
Trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
321939|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321940|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321913|NCT00266110|O1|Outcome|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion
sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.
therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.
trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
321914|NCT00266110|E1|Reported Event|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion
sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.
therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.
trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
321915|NCT00266227|B3|Baseline|Total|Total of all reporting groups
321916|NCT00266227|B2|Baseline|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321917|NCT00266227|B1|Baseline|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321918|NCT00266227|P3|Participant Flow|Rituximab-Not Randomized to Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.
321919|NCT00266227|P2|Participant Flow|Arm B: Placebo Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
321920|NCT00266227|P1|Participant Flow|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321921|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321922|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
322001|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
323105|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
321927|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321928|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321929|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321930|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321931|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321932|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321933|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
322019|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322020|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
321941|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321942|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321943|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321944|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321945|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321946|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321947|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321948|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321949|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321950|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321951|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321952|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321953|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321954|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321955|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321956|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321957|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
322002|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
321958|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321959|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
321960|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321961|NCT00266227|E3|Reported Event|Rituximab-Not Randomized to Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.
321962|NCT00266227|E2|Reported Event|Arm B: Placebo Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
321963|NCT00266227|E1|Reported Event|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
321964|NCT00266279|B1|Baseline|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.
Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):
Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
321965|NCT00266279|P1|Participant Flow|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.
Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):
Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
322191|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
321966|NCT00266279|O1|Outcome|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.
Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):
Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
321967|NCT00266279|E1|Reported Event|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.
Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):
Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
321968|NCT00266409|B5|Baseline|Total|Total of all reporting groups
321969|NCT00266409|B4|Baseline|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
321970|NCT00266409|B3|Baseline|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
321971|NCT00266409|B2|Baseline|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
321972|NCT00266409|B1|Baseline|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
321973|NCT00266409|P4|Participant Flow|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
321974|NCT00266409|P3|Participant Flow|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
321975|NCT00266409|P2|Participant Flow|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
321976|NCT00266409|P1|Participant Flow|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
321977|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
321978|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
321979|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
321980|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
321981|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
321982|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
321983|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
321984|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
321985|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
321986|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
321987|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
321988|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
321989|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
321990|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
321991|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
321992|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
321993|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
321994|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
321995|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
321996|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
321997|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
321998|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
321999|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
324080|NCT00285207|O1|Outcome|Placebo|Placebo (no treatment)
322004|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322005|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322006|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322007|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322008|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322009|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322010|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322011|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322012|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322013|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322014|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322015|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322016|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322017|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322018|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322026|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322027|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322028|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322029|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322030|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322031|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322032|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322033|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322034|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322035|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322036|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322037|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322038|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322039|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322040|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322041|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322042|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322043|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322044|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322045|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322046|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322047|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322048|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322049|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322050|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322051|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322052|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322053|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322054|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322055|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322056|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322057|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322058|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322059|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322060|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322061|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322062|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322063|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322064|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322065|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
324081|NCT00285207|E2|Reported Event|A007|Experimental A007
322066|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322067|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322068|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322069|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322070|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322071|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322072|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322073|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322074|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322075|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322076|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322077|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322078|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322079|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322080|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322247|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322081|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322082|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322083|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322084|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322085|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322086|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322087|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322088|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322089|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322090|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322091|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322092|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322093|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322094|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322095|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322096|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322097|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322098|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322099|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322100|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322101|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322102|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322103|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322104|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322105|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322106|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322107|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322108|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322109|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322110|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322111|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322112|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322113|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322114|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322115|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322116|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322117|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322118|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322119|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322120|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322121|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322122|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322123|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322124|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322125|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322126|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322127|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322128|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322129|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322130|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322131|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322132|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322133|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322134|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322135|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322421|NCT00274937|B1|Baseline|Stratum II|AJCC Stage IIb - IV
322136|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322137|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322138|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322139|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322140|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322141|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322142|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322143|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322144|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322145|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322146|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322147|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322148|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322149|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322150|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322151|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322152|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322153|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322154|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322155|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322156|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322157|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322158|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322159|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322160|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322161|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322162|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322163|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322164|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322165|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322166|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322167|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322168|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322169|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322170|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322171|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322172|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322173|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322174|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322175|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322176|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322177|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322178|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322179|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322180|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322181|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322182|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322183|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322184|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322185|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322186|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322187|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322188|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322189|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322190|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322422|NCT00274937|P1|Participant Flow|Stratum II|AJCC Stage IIb - IV
322192|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322193|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322194|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322195|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322196|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322197|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322198|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322199|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322200|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322201|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322202|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322203|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322204|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322205|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322206|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322207|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322208|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322209|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322210|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322211|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322212|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322213|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322214|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322215|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322216|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322217|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322218|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322219|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322220|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322221|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322222|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322223|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322224|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322225|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322226|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322227|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322228|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322229|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322230|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322231|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322232|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322233|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322234|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322235|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322236|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322237|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322238|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322239|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322240|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322241|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322242|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322243|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322244|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322245|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322246|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322423|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
322248|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322249|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322250|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322251|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322252|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322253|NCT00266409|E4|Reported Event|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
322254|NCT00266409|E3|Reported Event|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
322255|NCT00266409|E2|Reported Event|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
322256|NCT00266409|E1|Reported Event|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
322257|NCT00266630|B3|Baseline|Total|Total of all reporting groups
322258|NCT00266630|B2|Baseline|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322259|NCT00266630|B1|Baseline|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322260|NCT00266630|P2|Participant Flow|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322261|NCT00266630|P1|Participant Flow|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322262|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322263|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
322264|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322265|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
322266|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322267|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
322268|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322269|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
322270|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322271|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322302|NCT00266656|P1|Participant Flow|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Humatrope administered in B9R-US-GDFG (NCT00406926)."
322272|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322273|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322274|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322275|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322276|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322277|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322278|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322279|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322424|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
322425|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
322280|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322281|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322282|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322283|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322284|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322285|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322286|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
322287|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322288|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322289|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322290|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322291|NCT00266630|O1|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322292|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
322293|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
322294|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
322295|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
322296|NCT00266630|E2|Reported Event|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
322297|NCT00266630|E1|Reported Event|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
322298|NCT00266656|B3|Baseline|Total|Total of all reporting groups
322299|NCT00266656|B2|Baseline|Early Untreated|Early untreated n=33
322300|NCT00266656|B1|Baseline|Early Treated|Early treated n=36
322301|NCT00266656|P2|Participant Flow|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
322382|NCT00266825|E4|Reported Event|DHA Capsule - Infant|Infants born from Mothers in the DHA capsule group
322303|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
322304|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Humatrope administered in B9R-US-GDFG (NCT00406926)."
322305|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
322306|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Humatrope administered in B9R-US-GDFG (NCT00406926)."
322307|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
322308|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Humatrope administered in B9R-US-GDFG (NCT00406926)."
322309|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
322310|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Humatrope administered in B9R-US-GDFG (NCT00406926)."
322311|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
322426|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
322312|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Humatrope administered in B9R-US-GDFG (NCT00406926)."
322313|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
322314|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Humatrope administered in B9R-US-GDFG (NCT00406926)."
322315|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
322316|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Humatrope administered in B9R-US-GDFG (NCT00406926)."
322317|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
322318|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Humatrope administered in B9R-US-GDFG (NCT00406926)."
322319|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
322320|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.
Humatrope administered in B9R-US-GDFG (NCT00406926)."
322321|NCT00266656|E2|Reported Event|Early Untreated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.
Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
322322|NCT00266656|E1|Reported Event|Early Treated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.
Humatrope administered in B9R-US-GDFG (NCT00406926)."
322323|NCT00266695|B1|Baseline|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
322324|NCT00266695|P1|Participant Flow|Ruboxistaurin|32 milligrams (mg) given once daily as an oral tablet for 2 years.
322325|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
322326|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
322327|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
322328|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
322329|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
322330|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
322331|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
322332|NCT00266695|E1|Reported Event|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
322333|NCT00266799|B3|Baseline|Total|Total of all reporting groups
322334|NCT00266799|B2|Baseline|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
322335|NCT00266799|B1|Baseline|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
322336|NCT00266799|P2|Participant Flow|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
322337|NCT00266799|P1|Participant Flow|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
322338|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
322339|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
322340|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
322341|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
322342|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
322343|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
322344|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
322345|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
322346|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
322347|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
322516|NCT00276159|B1|Baseline|852A Treatment|Patients receiving at least 12 doses of 852A.
322348|NCT00266799|E2|Reported Event|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
322349|NCT00266799|E1|Reported Event|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
322350|NCT00266812|B3|Baseline|Total|Total of all reporting groups
322351|NCT00266812|B2|Baseline|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
322352|NCT00266812|B1|Baseline|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
322353|NCT00266812|P2|Participant Flow|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
322354|NCT00266812|P1|Participant Flow|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
322355|NCT00266812|O2|Outcome|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
322356|NCT00266812|O1|Outcome|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
322357|NCT00266812|E2|Reported Event|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
322358|NCT00266812|E1|Reported Event|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
322359|NCT00266825|B3|Baseline|Total|Total of all reporting groups
322360|NCT00266825|B2|Baseline|DHA Supplement|"DHA capsule
DHA: 600 mg DHA"
322361|NCT00266825|B1|Baseline|Placebo Capsule|"Placebo capsule
Placebo capsule: Placebo capsule"
322362|NCT00266825|P2|Participant Flow|DHA Supplement|"DHA capsule
DHA: 600 mg DHA"
322363|NCT00266825|P1|Participant Flow|Placebo Capsule|"Placebo capsule
Placebo capsule: Placebo capsule"
322364|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule
DHA: 600 mg DHA"
322365|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo capsule: Placebo capsule"
322366|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule
DHA: 600 mg DHA"
322367|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo capsule: Placebo capsule"
322368|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule
DHA: 600 mg DHA"
322369|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo capsule: Placebo capsule"
322370|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule
DHA: 600 mg DHA"
322371|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo capsule: Placebo capsule"
322372|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule
DHA: 600 mg DHA"
322373|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo capsule: Placebo capsule"
322374|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule
DHA: 600 mg DHA"
322375|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo capsule: Placebo capsule"
322376|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule
DHA: 600 mg DHA"
322377|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo capsule: Placebo capsule"
322378|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule
DHA: 600 mg DHA"
322379|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo capsule: Placebo capsule"
322380|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule
DHA: 600 mg DHA"
322381|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo capsule: Placebo capsule"
322384|NCT00266825|E2|Reported Event|Placebo Capsule - Infant|Infants born from Mothers in the Placebo capsule group
322385|NCT00266825|E1|Reported Event|Placebo Capsule - Mother|"Placebo capsule
Placebo capsule: Placebo capsule"
322386|NCT00266864|B3|Baseline|Total|Total of all reporting groups
322387|NCT00266864|B2|Baseline|No Intervention|Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.
322388|NCT00266864|B1|Baseline|Testosterone Replacement Therapy|Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
322389|NCT00266864|P2|Participant Flow|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
322390|NCT00266864|P1|Participant Flow|Testosterone Replacement Therapy|Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
322391|NCT00266864|O2|Outcome|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
322392|NCT00266864|O1|Outcome|Testosterone Replacement Therapy|Testosterone Replacement Therapy Patch 5 or 10 mg daily
322393|NCT00266864|O2|Outcome|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
322394|NCT00266864|O1|Outcome|Testosterone Replacement Therapy|Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
322395|NCT00266864|E1|Reported Event|Testosterone Replacement Therapy|A prospective, open-label, controlled drug intervention trial was performed in healthy hypogonadal and eugonadal outpatient men with chronic spinal cord injury (Treatment: serum testosterone concentration <4.0 mg/dL and Control: serum testosterone concentration ≥4.0 mg/dL). Treatment subjects received a transdermal testosterone patch (5 or 10 mg; Androderm, Watson Pharma Inc.) daily for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range. Only outcome measures were assessed for the no intervention arm; no adverse events were collected.
322396|NCT00267007|B3|Baseline|Total|Total of all reporting groups
322397|NCT00267007|B2|Baseline|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
322398|NCT00267007|B1|Baseline|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
322399|NCT00267007|P2|Participant Flow|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
322400|NCT00267007|P1|Participant Flow|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
322401|NCT00267007|O2|Outcome|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
322402|NCT00267007|O1|Outcome|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
322403|NCT00267007|O2|Outcome|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
322404|NCT00267007|O1|Outcome|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
322405|NCT00267007|E2|Reported Event|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
322406|NCT00267007|E1|Reported Event|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
322407|NCT00274924|B4|Baseline|Total|Total of all reporting groups
322408|NCT00274924|B3|Baseline|No Mid-Treatment PET|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
322409|NCT00274924|B2|Baseline|Group II (PET Negative)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
322410|NCT00274924|B1|Baseline|Group I (PET Positive)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
322411|NCT00274924|P3|Participant Flow|No Mid-Treatment PET|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
322412|NCT00274924|P2|Participant Flow|Group II (PET Negative)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
322563|NCT00276406|P2|Participant Flow|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322413|NCT00274924|P1|Participant Flow|Group I (PET Positive)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
322414|NCT00274924|O2|Outcome|Group II (PET Positive)|Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
322415|NCT00274924|O1|Outcome|Group I (PET Negative)|Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
322416|NCT00274924|O2|Outcome|Group II (PET Positive)|Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
322417|NCT00274924|O1|Outcome|Group I (PET Negative)|Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
322418|NCT00274924|E3|Reported Event|Step 2 - Mid-treatment PET Negative|Patients who were mid-treatment PET negative and who received additional R-CHOP in step 2 regardless of eligibility.
322419|NCT00274924|E2|Reported Event|Step 2 - Mid-treatment PET Positive|Patients who were mid-treatment PET positive and who received R-ICE in step 2 regardless of eligibility.
322420|NCT00274924|E1|Reported Event|Step 1 - All Treated Patients|All treated patients regardless of eligibility.
322427|NCT00274937|E1|Reported Event|Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)|"Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.
amifostine trihydrate: Given subcutaneously
fluorouracil: Given IV
cisplatin: Given IV
laboratory biomarker analysis: Correlative studies
radiation therapy: Undergo radiotherapy"
322428|NCT00275002|B3|Baseline|Total|Total of all reporting groups
322429|NCT00275002|B2|Baseline|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
322430|NCT00275002|B1|Baseline|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
322431|NCT00275002|P2|Participant Flow|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
322432|NCT00275002|P1|Participant Flow|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
322433|NCT00275002|O2|Outcome|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
322434|NCT00275002|O1|Outcome|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
322435|NCT00275002|O2|Outcome|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
322436|NCT00275002|O1|Outcome|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
322437|NCT00275002|E2|Reported Event|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
322438|NCT00275002|E1|Reported Event|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
322439|NCT00275028|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
324082|NCT00285207|E1|Reported Event|Placebo|Placebo (no treatment)
322440|NCT00275028|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
322441|NCT00275028|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
322442|NCT00275028|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
322443|NCT00275028|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
322444|NCT00276016|B7|Baseline|Total|Total of all reporting groups
322445|NCT00276016|B6|Baseline|Placebo, Pseudoephedrine, Phenylephrine|Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
322446|NCT00276016|B5|Baseline|Pseudoephedrine, Phenylephrine, Placebo|"Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release
12 mg capsules for oral administration. Placebo: Placebo capsules."
322517|NCT00276159|P1|Participant Flow|852A Treatment|Patients receiving at least 12 doses of 852A.
322447|NCT00276016|B4|Baseline|Phenylephrine, Placebo, Pseudoephedrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
322448|NCT00276016|B3|Baseline|Placebo, Phenylephrine, Pseudoephedrine|Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
322449|NCT00276016|B2|Baseline|Pseudoephedrine, Placebo, Phenylephrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
322450|NCT00276016|B1|Baseline|Phenylephrine, Pseudoephedrine, Placebo|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
322451|NCT00276016|P6|Participant Flow|Placebo, Pseudoephedrine, Phenylephrine|Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
322452|NCT00276016|P5|Participant Flow|Pseudoephedrine, Phenylephrine, Placebo|"Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release
12 mg capsules for oral administration. Placebo: Placebo capsules."
322453|NCT00276016|P4|Participant Flow|Phenylephrine, Placebo, Pseudoephedrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
322454|NCT00276016|P3|Participant Flow|Placebo, Phenylephrine, Pseudoephedrine|Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
322455|NCT00276016|P2|Participant Flow|Pseudoephedrine, Placebo, Phenylephrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
322456|NCT00276016|P1|Participant Flow|Phenylephrine, Pseudoephedrine, Placebo|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
322457|NCT00276016|O2|Outcome|Placebo|
322458|NCT00276016|O1|Outcome|Pseudoephedrine|
322459|NCT00276016|O2|Outcome|Phenylephrine|
322460|NCT00276016|O1|Outcome|Placebo|
322461|NCT00276016|E3|Reported Event|Placebo|Placebo: Placebo capsules.
322462|NCT00276016|E2|Reported Event|Pseudoephedrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
322463|NCT00276016|E1|Reported Event|Phenylephrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration.
322464|NCT00276094|B4|Baseline|Total|Total of all reporting groups
322465|NCT00276094|B3|Baseline|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322466|NCT00276094|B2|Baseline|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322467|NCT00276094|B1|Baseline|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322468|NCT00276094|P3|Participant Flow|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322469|NCT00276094|P2|Participant Flow|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322653|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
324083|NCT00275262|B3|Baseline|Total|Total of all reporting groups
322470|NCT00276094|P1|Participant Flow|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322471|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322472|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322473|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322474|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322475|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322476|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322477|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322478|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322479|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322480|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322481|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322482|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322483|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322484|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322485|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322486|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322487|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322488|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322489|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322490|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322491|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322492|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322493|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322494|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322495|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322496|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322497|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322498|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322499|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322500|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322501|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322502|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322503|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322504|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322505|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322506|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322507|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322508|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322509|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322510|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322511|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322512|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322513|NCT00276094|E3|Reported Event|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322514|NCT00276094|E2|Reported Event|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322515|NCT00276094|E1|Reported Event|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
322521|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
322522|NCT00276159|E1|Reported Event|852A Treatment|Patients receiving at least 12 doses of 852A.
322523|NCT00276250|B4|Baseline|Total|Total of all reporting groups
322524|NCT00276250|B3|Baseline|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322525|NCT00276250|B2|Baseline|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322526|NCT00276250|B1|Baseline|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322527|NCT00276250|P3|Participant Flow|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322528|NCT00276250|P2|Participant Flow|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322529|NCT00276250|P1|Participant Flow|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322530|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322531|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322532|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322533|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322534|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322535|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322536|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322537|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322538|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322539|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322540|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322541|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322542|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322543|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322544|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322545|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322546|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322547|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322548|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322549|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322550|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322551|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322552|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322553|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322554|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322555|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322556|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322557|NCT00276250|E3|Reported Event|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
322558|NCT00276250|E2|Reported Event|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
322559|NCT00276250|E1|Reported Event|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
322560|NCT00276406|B3|Baseline|Total|Total of all reporting groups
322561|NCT00276406|B2|Baseline|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322562|NCT00276406|B1|Baseline|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322564|NCT00276406|P1|Participant Flow|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322565|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322566|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322567|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322568|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322569|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322570|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322571|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322572|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322573|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322574|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322575|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322576|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322577|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322578|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322579|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322580|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322581|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322582|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322583|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322584|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322585|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322586|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322587|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322588|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322589|NCT00276406|E2|Reported Event|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
322590|NCT00276406|E1|Reported Event|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
322591|NCT00276419|B3|Baseline|Total|Total of all reporting groups
322592|NCT00276419|B2|Baseline|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
322593|NCT00276419|B1|Baseline|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
322594|NCT00276419|P2|Participant Flow|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
322595|NCT00276419|P1|Participant Flow|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
322654|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
327767|NCT00293813|O3|Outcome|Placebo|Placebo
322596|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
322597|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
322598|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
322599|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
322600|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
322601|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
322602|NCT00276419|E2|Reported Event|Diclofenac|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
322603|NCT00276419|E1|Reported Event|Placebo|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
322604|NCT00276458|B3|Baseline|Total|Total of all reporting groups
322605|NCT00276458|B2|Baseline|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322606|NCT00276458|B1|Baseline|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322607|NCT00276458|P2|Participant Flow|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322608|NCT00276458|P1|Participant Flow|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322609|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322610|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322611|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322612|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322613|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322614|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322615|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322616|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322617|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322618|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322619|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322620|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322621|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322622|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322623|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322624|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322625|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322626|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322627|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322628|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322629|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322630|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322631|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322632|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322633|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322634|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322635|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322636|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322637|NCT00276458|E2|Reported Event|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
322638|NCT00276458|E1|Reported Event|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
322639|NCT00276484|B3|Baseline|Total|Total of all reporting groups
322640|NCT00276484|B2|Baseline|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322641|NCT00276484|B1|Baseline|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322642|NCT00276484|P2|Participant Flow|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322643|NCT00276484|P1|Participant Flow|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322644|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322645|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322646|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322647|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322648|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322649|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322650|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322651|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322652|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322655|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322656|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322657|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322658|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322659|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322660|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322661|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322662|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322663|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322664|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322665|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322666|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322667|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322668|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322669|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322670|NCT00276484|E2|Reported Event|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
322671|NCT00276484|E1|Reported Event|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
322672|NCT00276549|B1|Baseline|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
322673|NCT00276549|P1|Participant Flow|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
322674|NCT00276549|O1|Outcome|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
322675|NCT00276549|O1|Outcome|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
322676|NCT00276549|E1|Reported Event|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
322677|NCT00276614|B1|Baseline|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
322678|NCT00276614|P1|Participant Flow|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
322679|NCT00276614|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
322680|NCT00276614|E1|Reported Event|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
322681|NCT00276861|B1|Baseline|Single Arm|
322682|NCT00276861|P1|Participant Flow|Oxaliplatin + Gemcitabine|
322683|NCT00276861|O1|Outcome|Oxaliplatin + Gemcitabine|
322684|NCT00276861|O1|Outcome|Single Arm|
322685|NCT00276861|E1|Reported Event|Single Arm|
322686|NCT00277095|B1|Baseline|ProACT|Implantable device
322687|NCT00277095|P1|Participant Flow|Implantable Device|ProACT Implantable device for treatment of post-prostatectomy stress urinary incontinence in males.
322688|NCT00277095|O1|Outcome|Urine Loss ( in Grams)|24 hour pad weight(in grams) demonstrating 50% reduction in urine loss (in grams)over 18th month
322689|NCT00277095|E1|Reported Event|ProACT|Implantable device
322690|NCT00277212|B1|Baseline|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
322691|NCT00277212|P3|Participant Flow|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322692|NCT00277212|P2|Participant Flow|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322693|NCT00277212|P1|Participant Flow|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
322694|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322695|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322696|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322697|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322698|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322699|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322700|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
323106|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
322701|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322702|NCT00277212|O1|Outcome|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
322703|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322704|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322705|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322706|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322707|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322708|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322709|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322710|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
328598|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
322711|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322712|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322713|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322714|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322715|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322716|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322717|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322718|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322719|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322720|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322721|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322722|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322723|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322724|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322725|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322726|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322727|NCT00277212|E3|Reported Event|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
322728|NCT00277212|E2|Reported Event|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
322729|NCT00277212|E1|Reported Event|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
322730|NCT00277355|B3|Baseline|Total|Total of all reporting groups
322731|NCT00277355|B2|Baseline|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
322732|NCT00277355|B1|Baseline|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
322733|NCT00277355|P2|Participant Flow|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization).
322734|NCT00277355|P1|Participant Flow|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
322735|NCT00277355|O2|Outcome|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization).
322736|NCT00277355|O1|Outcome|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
322737|NCT00277355|O2|Outcome|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
322738|NCT00277355|O1|Outcome|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
322739|NCT00277355|E2|Reported Event|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
322740|NCT00277355|E1|Reported Event|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
322741|NCT00277394|B3|Baseline|Total|Total of all reporting groups
322742|NCT00277394|B2|Baseline|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
322743|NCT00277394|B1|Baseline|Innohep®|innohep® 175 anti-Xa IU/kg once daily
322744|NCT00277394|P2|Participant Flow|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
322745|NCT00277394|P1|Participant Flow|Innohep®|innohep® 175 anti-Xa IU/kg once daily
322746|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
322747|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
322748|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
322749|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
322750|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
322751|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
322752|NCT00277394|E2|Reported Event|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
322753|NCT00277394|E1|Reported Event|Innohep®|innohep® 175 anti-Xa IU/kg once daily
322754|NCT00277446|B1|Baseline|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
328599|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
322755|NCT00277446|P1|Participant Flow|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
322756|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
322757|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
322758|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
322759|NCT00277446|E1|Reported Event|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
322760|NCT00277524|B1|Baseline|Overall|All patients enrolled in OMNI.
322761|NCT00277524|P4|Participant Flow|Subjects With CRT-D|Subjects implanted with a cardiac resynchronization therapy defibrillator (CRT-D).
322762|NCT00277524|P3|Participant Flow|Subjects With Dual Chamber ICD|Subjects implanted with a dual chamber implantable cardioverter defibrillator (ICD).
322763|NCT00277524|P2|Participant Flow|Subjects With Single Chamber ICD|Subjects implanted with a single chamber implantable cardioverter defibrillator (ICD).
322764|NCT00277524|P1|Participant Flow|Subjects With IPG|Subjects implanted with an implantable pulse generator (IPG).
322765|NCT00277524|O1|Outcome|ICD/CRT-D Group|Subjects implanted with Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy-Defibrillator (ICD/CRT-D).
322766|NCT00277524|O4|Outcome|48-month Follow-up|Total subjects with disease progressed at 48 months
322767|NCT00277524|O3|Outcome|36-month Follow-up|Total subjects with disease progressed at 36 months
322768|NCT00277524|O2|Outcome|24-month Follow-up|Total subjects with disease progressed at 24 months
322769|NCT00277524|O1|Outcome|12-month Follow-up|Total subjects with disease progressed at 12 months
322770|NCT00277524|O2|Outcome|"SCD-HeFT Programming"|OMNI “SCD-HeFT” definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of <320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms.
322771|NCT00277524|O1|Outcome|"PainFREE Programming"|OMNI “PainFREE” definition: programming combinations that result in ATP therapy for VT at cycle lengths <320 ms. Programming at cycle lengths ≥320 ms were not mandated.
322772|NCT00277524|O1|Outcome|ATP During Charging|Patients who had an episode and were programmed with the ATP during charging feature.
322773|NCT00277524|O2|Outcome|Patients With History of AV Block|Patients with MVP enabled and follow up data available
322774|NCT00277524|O1|Outcome|Patients Without History of AV Block|Patients with MVP enabled and follow up data available
322775|NCT00277524|O2|Outcome|ICD (N=1029)|ICD Patients with MVP enabled and follow up data available
322776|NCT00277524|O1|Outcome|IPG (N=610)|IPG Patients with MVP enabled and follow up data available
322777|NCT00277524|O1|Outcome|ICD/CRT-D Group|Subjects implanted with ICD/CRT-D
322778|NCT00277524|O1|Outcome|IPG Group|Subjects implanted with IPG
322779|NCT00277524|O1|Outcome|Implanted Subjects|All patients enrolled in OMNI.
322780|NCT00277524|E1|Reported Event||The Medtronic OMNI Study is a post-market observational study conducted in the United States (US). Adverse events were not collected as a part of the OMNI study. Sites were instructed to report applicable events in the same manner as required for any commercially available device, through the Medical Device Reporting (MDR) process.
322781|NCT00278343|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
laboratory biomarker analysis: Correlative studies"
322782|NCT00278343|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
laboratory biomarker analysis: Correlative studies"
322783|NCT00278343|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
cediranib maleate: 30mg given PO, daily"
322784|NCT00278343|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
laboratory biomarker analysis: Correlative studies"
322785|NCT00278343|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
laboratory biomarker analysis: Correlative studies"
322786|NCT00278343|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
laboratory biomarker analysis: Correlative studies"
322787|NCT00278343|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given PO
laboratory biomarker analysis: Correlative studies"
322788|NCT00278395|B1|Baseline|Vorinostat|The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
322789|NCT00278395|P1|Participant Flow|Vorinostat|The oral dose of vorinostat capsules was 300 mg two times a day for 3 consecutive days every week for 4 weeks, which constitutes on cycle of treatment. Treatment will be administered on an outpatient basis.
322790|NCT00278395|O1|Outcome|Vorinostat|The dose of Vorinostat was 300 mg BID on the first 3 days of every week on a 4-week cycle. Dose reduction was allowed for adverse events (AE). Treatment was planned until disease progression (PD), death, unacceptable toxicity, or consent withdrawal.
322791|NCT00278395|E1|Reported Event|Vorinostat|The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
322792|NCT00278473|B3|Baseline|Total|Total of all reporting groups
322793|NCT00278473|B2|Baseline|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322794|NCT00278473|B1|Baseline|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322795|NCT00278473|P2|Participant Flow|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322796|NCT00278473|P1|Participant Flow|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322797|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322798|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322799|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322800|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322801|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322802|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322803|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322804|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322805|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322806|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322807|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322808|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322809|NCT00278473|E2|Reported Event|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322810|NCT00278473|E1|Reported Event|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
322811|NCT00270205|B5|Baseline|Total|Total of all reporting groups
322812|NCT00270205|B4|Baseline|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322813|NCT00270205|B3|Baseline|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322860|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322814|NCT00270205|B2|Baseline|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322815|NCT00270205|B1|Baseline|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322816|NCT00270205|P4|Participant Flow|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322817|NCT00270205|P3|Participant Flow|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322818|NCT00270205|P2|Participant Flow|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322819|NCT00270205|P1|Participant Flow|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322820|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
323001|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
322821|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322822|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322823|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322824|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322825|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322826|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322827|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322828|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322829|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322830|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322831|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322832|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322833|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322834|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322835|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322836|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322980|NCT00270634|P1|Participant Flow|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
322837|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322838|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322839|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322840|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322841|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322842|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322843|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
323002|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
322844|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322845|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322846|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322847|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322848|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322849|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322850|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322851|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322852|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322853|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322854|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322855|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322856|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322857|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322858|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322859|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322861|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322862|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322863|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322864|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322865|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322866|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
323003|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
323004|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
322867|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322868|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322869|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322870|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322871|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322872|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322873|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322874|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322875|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322876|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322877|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322878|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322879|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322880|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322881|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322882|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322981|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
327768|NCT00293813|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
322883|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322884|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322885|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322886|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322887|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322888|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322889|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
323005|NCT00270634|O4|Outcome|Tacrolimus|Standard dose
323006|NCT00270634|O3|Outcome|Low Dose Voclosporin|Starting dose of 0.4 mg/kg
323007|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Starting dose of 0.6 mg/kg
322890|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322891|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322892|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322893|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322894|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322895|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322896|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322897|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322898|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322899|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322900|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322901|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322902|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322903|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322904|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322905|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322906|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322907|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322908|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322909|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322910|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322911|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322912|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
323008|NCT00270634|O1|Outcome|High Dose Voclosporin|Starting dose of 0.8 mg/kg
323009|NCT00270634|E4|Reported Event|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
328600|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
322913|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322914|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322915|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322916|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322917|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322918|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322919|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322920|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322921|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322922|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322923|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322924|NCT00270205|E4|Reported Event|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
322925|NCT00270205|E3|Reported Event|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
322926|NCT00270205|E2|Reported Event|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
322927|NCT00270205|E1|Reported Event|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
322928|NCT00270231|B1|Baseline|Entire Study Population|Includes subjects with both OPRM1 genotypes (Asp40 (A/G or G/G allele vs. Asn40 (A/A) allele) who started Intervention Period 1.
322929|NCT00270231|P2|Participant Flow|Placebo, Then Naltrexone|"These participants took placebo (sugar pill) during their first 4-day study period.
They received active naltrexone during the second 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg."
322930|NCT00270231|P1|Participant Flow|Naltrexone, Then Placebo|"These participants took active naltrexone during their first 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg.
They received placebo (sugar pill) during the second 4-day study period."
322931|NCT00270231|O2|Outcome|OPRM1 Genotype - A/G or G/G|Participants who have the Asp40 OPRM1=A/G or G/G
322932|NCT00270231|O1|Outcome|OPRM1 Genotype - A/A|Participants who have the Asn40 OPRM1=A/A
322933|NCT00270231|E2|Reported Event|Placebo Only|Placebo (sugar pill) recipients (taken for four days).
322934|NCT00270231|E1|Reported Event|Naltrexone Only|Active medication recipients (Naltrexone taken for 4 days).
322935|NCT00270257|B3|Baseline|Total|Total of all reporting groups
322936|NCT00270257|B2|Baseline|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.
Buprenorphine/Naloxone: Oral tablet"
322937|NCT00270257|B1|Baseline|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52
Buprenorphine/Naloxone: Oral tablet"
322938|NCT00270257|P2|Participant Flow|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.
Buprenorphine/Naloxone: Oral tablet"
322939|NCT00270257|P1|Participant Flow|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52
Buprenorphine/Naloxone: Oral tablet"
322940|NCT00270257|O2|Outcome|Thailand|Long Term and Short arms were compared
322941|NCT00270257|O1|Outcome|China|Long Term and Short arms were compared
322942|NCT00270257|O2|Outcome|Thailand|Long Term and Short arms were compared
322943|NCT00270257|O1|Outcome|China|Long Term and Short arms were compared
322944|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.
Buprenorphine/Naloxone: Oral tablet"
322945|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52
Buprenorphine/Naloxone: Oral tablet"
322946|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.
Buprenorphine/Naloxone: Oral tablet"
322947|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52
Buprenorphine/Naloxone: Oral tablet"
322948|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.
Buprenorphine/Naloxone: Oral tablet"
322949|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52
Buprenorphine/Naloxone: Oral tablet"
322950|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.
Buprenorphine/Naloxone: Oral tablet"
322951|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52
Buprenorphine/Naloxone: Oral tablet"
322952|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.
Buprenorphine/Naloxone: Oral tablet"
322953|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52
Buprenorphine/Naloxone: Oral tablet"
322954|NCT00270257|E2|Reported Event|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.
Buprenorphine/Naloxone: Oral tablet"
322982|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
322983|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
322955|NCT00270257|E1|Reported Event|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52
Buprenorphine/Naloxone: Oral tablet"
322956|NCT00270296|B4|Baseline|Total|Total of all reporting groups
322957|NCT00270296|B3|Baseline|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.
Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
322958|NCT00270296|B2|Baseline|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
322959|NCT00270296|B1|Baseline|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
322960|NCT00270296|P3|Participant Flow|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.
Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
322961|NCT00270296|P2|Participant Flow|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
323076|NCT00270998|E2|Reported Event|Behavioral Therapy|Pelvic muscle training and exercises
322962|NCT00270296|P1|Participant Flow|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
322963|NCT00270296|O3|Outcome|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.
Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
322964|NCT00270296|O2|Outcome|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
322965|NCT00270296|O1|Outcome|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
322966|NCT00270296|O3|Outcome|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.
Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
322967|NCT00270296|O2|Outcome|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
322968|NCT00270296|O1|Outcome|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
322969|NCT00270296|E3|Reported Event|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.
Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
322970|NCT00270296|E2|Reported Event|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
322971|NCT00270296|E1|Reported Event|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
322972|NCT00270634|B5|Baseline|Total|Total of all reporting groups
322973|NCT00270634|B4|Baseline|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
322974|NCT00270634|B3|Baseline|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
322975|NCT00270634|B2|Baseline|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
322976|NCT00270634|B1|Baseline|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
322977|NCT00270634|P4|Participant Flow|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
322978|NCT00270634|P3|Participant Flow|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
322979|NCT00270634|P2|Participant Flow|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
322984|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
322985|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
322986|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
322987|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
322988|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
322989|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
322990|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
322991|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
322992|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
322993|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
322994|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
322995|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
322996|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
322997|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
322998|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
322999|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
323000|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
323010|NCT00270634|E3|Reported Event|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
323011|NCT00270634|E2|Reported Event|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
323012|NCT00270634|E1|Reported Event|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
323013|NCT00270790|B1|Baseline|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.
Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation
Carboplatin: Carboplatin for 100 mg/m2
Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose
Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
323014|NCT00270790|P1|Participant Flow|AMIFOSTINE +2 Chemo Lines +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.
Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation
Carboplatin: Carboplatin for 100 mg/m2
Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose
Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
323015|NCT00270790|O1|Outcome|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.
Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation
Carboplatin: Carboplatin for 100 mg/m2
Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose
Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
323016|NCT00270790|O1|Outcome|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.
Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation
Carboplatin: Carboplatin for 100 mg/m2
Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose
Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
323017|NCT00270790|E1|Reported Event|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.
Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation
Carboplatin: Carboplatin for 100 mg/m2
Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose
Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
323018|NCT00270842|B4|Baseline|Total|Total of all reporting groups
323019|NCT00270842|B3|Baseline|Tai Chi|"Exercise Group that participated in tai chi training classes
Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
323020|NCT00270842|B2|Baseline|Functional Balance Training|"Exercise group that participated in functional balance training
Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
323021|NCT00270842|B1|Baseline|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.
Education Control group: This control group participated in 10 weeks of general health education classes."
323022|NCT00270842|P3|Participant Flow|Tai Chi|"Exercise Group that participated in tai chi training classes
Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
323023|NCT00270842|P2|Participant Flow|Functional Balance Training|"Exercise group that participated in functional balance training
Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
323024|NCT00270842|P1|Participant Flow|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.
Education Control group: This control group participated in 10 weeks of general health education classes."
323025|NCT00270842|O3|Outcome|Tai Chi|"Exercise Group that participated in tai chi training classes
Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
323026|NCT00270842|O2|Outcome|Functional Balance Training|"Exercise group that participated in functional balance training
Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
323027|NCT00270842|O1|Outcome|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.
Education Control group: This control group participated in 10 weeks of general health education classes."
323028|NCT00270842|O3|Outcome|Tai Chi|"Exercise Group that participated in tai chi training classes
Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
323029|NCT00270842|O2|Outcome|Functional Balance Training|"Exercise group that participated in functional balance training
Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
323030|NCT00270842|O1|Outcome|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.
Education Control group: This control group participated in 10 weeks of general health education classes."
323031|NCT00270842|E3|Reported Event|Tai Chi|"Exercise Group that participated in tai chi training classes
Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
323032|NCT00270842|E2|Reported Event|Functional Balance Training|"Exercise group that participated in functional balance training
Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
323033|NCT00270842|E1|Reported Event|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.
Education Control group: This control group participated in 10 weeks of general health education classes."
328601|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
323034|NCT00270894|B1|Baseline|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
323035|NCT00270894|P1|Participant Flow|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
323036|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
323037|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
323038|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
323039|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
323040|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
323041|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
323042|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
323043|NCT00270894|E1|Reported Event|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
323044|NCT00270998|B4|Baseline|Total|Total of all reporting groups
323045|NCT00270998|B3|Baseline|Combination of Pessary and Behavioral Therapy|Treatment includes a combination of both pessary and pelvic muscle exercises
323046|NCT00270998|B2|Baseline|Behavioral Therapy|Pelvic muscle training and exercises
323047|NCT00270998|B1|Baseline|Pessary|Intravaginal pessary
323048|NCT00270998|P3|Participant Flow|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
323049|NCT00270998|P2|Participant Flow|Behavioral Therapy|Pelvic muscle training and exercises
323050|NCT00270998|P1|Participant Flow|Pessary|Intravaginal incontinence pessary
323051|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
323052|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
323053|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
323054|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
323055|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
323056|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
323057|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
323060|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
323061|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
323062|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
323063|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
323064|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
323065|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
323066|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
323067|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
323068|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
323069|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
323070|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
323071|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
323072|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment includes a combination of both pessary and pelvic muscle exercises
323073|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
323074|NCT00270998|O1|Outcome|Pessary|Intravaginal pessary
323075|NCT00270998|E3|Reported Event|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
323077|NCT00270998|E1|Reported Event|Pessary|Intravaginal incontinence pessary
323078|NCT00271011|B1|Baseline|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.
Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.
Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
323079|NCT00271011|P1|Participant Flow|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.
Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.
Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
323080|NCT00271011|O1|Outcome|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.
Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.
Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
323081|NCT00271011|O1|Outcome|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.
Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.
Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
323082|NCT00271011|E1|Reported Event|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.
Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.
Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
323083|NCT00271024|B5|Baseline|Total|Total of all reporting groups
323084|NCT00271024|B4|Baseline|Placebo - FEMALE|Females receiving placebo as part of the trial
323085|NCT00271024|B3|Baseline|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
323086|NCT00271024|B2|Baseline|Placebo - MALE|Males receiving placebo as part of the trial
323087|NCT00271024|B1|Baseline|Naltrexone - MALE|Males receiving naltrexone as part of the trial
323088|NCT00271024|P4|Participant Flow|Placebo - FEMALE|Females receiving placebo as part of the trial
323089|NCT00271024|P3|Participant Flow|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
323090|NCT00271024|P2|Participant Flow|Placebo - MALE|Males receiving placebo as part of the trial
323091|NCT00271024|P1|Participant Flow|Naltrexone - MALE|Males receiving naltrexone as part of the trial
323092|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
323093|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
323094|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
323095|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
323096|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
323097|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
323098|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
323099|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
323100|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
323101|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
323102|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
323103|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
323104|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
323107|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
323108|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
323109|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
323110|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
323111|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
323112|NCT00271024|O2|Outcome|Naltrexone|Participants receiving Naltrexone as part of the trial
323113|NCT00271024|O1|Outcome|Placebo|Participants receiving Placebo as part of the trial
323114|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
323115|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
323116|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
323117|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
323118|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
323119|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
323120|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
323121|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
323122|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
323123|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
323124|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
323125|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
323126|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
323127|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
323128|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
323129|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
323130|NCT00271024|E2|Reported Event|Naltrexone|Participants receiving Naltrexone as part of the trial
323131|NCT00271024|E1|Reported Event|Placebo|Participants receiving Placebo as part of the trial
323132|NCT00271154|B3|Baseline|Total|Total of all reporting groups
323133|NCT00271154|B2|Baseline|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
323134|NCT00271154|B1|Baseline|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
323135|NCT00271154|P2|Participant Flow|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
323136|NCT00271154|P1|Participant Flow|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
323137|NCT00271154|O2|Outcome|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
323138|NCT00271154|O1|Outcome|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
323139|NCT00271154|O2|Outcome|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
323140|NCT00271154|O1|Outcome|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
323141|NCT00271154|E3|Reported Event|Not Randomized|These patients were enrolled in the study, but not randomized to CRT ON or CRT OFF. Their adverse events were collected until they exited the study.
323142|NCT00271154|E2|Reported Event|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
323143|NCT00271154|E1|Reported Event|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
323144|NCT00271219|B3|Baseline|Total|Total of all reporting groups
323145|NCT00271219|B2|Baseline|Buprenorphine|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323146|NCT00271219|B1|Baseline|Methadone|"Methadone
Methadone : daily oral dosing 20-140 mg"
323147|NCT00271219|P2|Participant Flow|Buprenorphine|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323148|NCT00271219|P1|Participant Flow|Methadone|"Methadone
Methadone : daily oral dosing 20-140 mg"
323149|NCT00271219|O2|Outcome|Buprenorphine|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323150|NCT00271219|O1|Outcome|Methadone|"Methadone
Methadone : daily oral dosing 20-140 mg"
323151|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323152|NCT00271219|O1|Outcome|A Methadone|"Methadone
Methadone : daily oral dosing 20-140 mg"
323153|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323154|NCT00271219|O1|Outcome|A Methadone|"Methadone
Methadone : daily oral dosing 20-140 mg"
323155|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323156|NCT00271219|O1|Outcome|A Methadone|"Methadone
Methadone : daily oral dosing 20-140 mg"
323157|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323158|NCT00271219|O1|Outcome|A Methadone|"Methadone
Methadone : daily oral dosing 20-140 mg"
323159|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323160|NCT00271219|O1|Outcome|A Methadone|"Methadone
Methadone : daily oral dosing 20-140 mg"
323161|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323162|NCT00271219|O1|Outcome|A Methadone|"Methadone
Methadone : daily oral dosing 20-140 mg"
323163|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323164|NCT00271219|O1|Outcome|A Methadone|"Methadone
Methadone : daily oral dosing 20-140 mg"
323165|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323166|NCT00271219|O1|Outcome|A Methadone|"Methadone
Methadone : daily oral dosing 20-140 mg"
323167|NCT00271219|E4|Reported Event|Buprenorphine: Neonates|Neonates born to mothers maintained on buprenorphine
323168|NCT00271219|E3|Reported Event|Methadone: Neonates|Neonates born to mothers maintained on methadone
323169|NCT00271219|E2|Reported Event|Buprenorphine: Mothers|"Buprenorphine
Buprenorphine : sl daily 2-32 mg"
323170|NCT00271219|E1|Reported Event|Methadone: Mothers|"Methadone
Methadone : daily oral dosing 20-140 mg"
323171|NCT00271375|B4|Baseline|Total|Total of all reporting groups
323172|NCT00271375|B3|Baseline|Control Group Usual Care|Control: Control group usual care
323173|NCT00271375|B2|Baseline|Caring for You, Caring for me + Social Worker (Educational Int|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323174|NCT00271375|B1|Baseline|Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323175|NCT00271375|P3|Participant Flow|Control Group Usual Care|Control: Control group usual care
323176|NCT00271375|P2|Participant Flow|Caring for You, Caring for me + Social Worker (Educational Int|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323177|NCT00271375|P1|Participant Flow|Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323178|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
323378|NCT00272311|B3|Baseline|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
323179|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323180|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323181|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
323182|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323183|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323184|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
323185|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323186|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323187|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
323188|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323189|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323190|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
323191|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323192|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323193|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
323194|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323195|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323196|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
323197|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323198|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323199|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
323200|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323201|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323202|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
323203|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323204|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323205|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
323206|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323207|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323208|NCT00271375|O1|Outcome|Overall Evaluation|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323209|NCT00271375|E3|Reported Event|Arm 3: Control Group Usual Care|Control: Control group usual care
323210|NCT00271375|E2|Reported Event|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
323211|NCT00271375|E1|Reported Event|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
323212|NCT00271544|B1|Baseline|4196 Lead|Subjects underwent Model 4196 left ventricular lead implant attempt
323213|NCT00271544|P1|Participant Flow|4196 Lead|Subjects underwent Model 4196 left ventricular lead implant attempt
323214|NCT00271544|O1|Outcome|4196 Lead|All enrolled subjects
323215|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode pacing impedance at 12-month
323216|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode threshold captured at 0.5ms at 12-month
323217|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode R-wave amplitude at implant
323218|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode pacing impedance at 12-month
323219|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode threshold captured at 0.5ms at 12-month
323220|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode R-wave amplitude at 12-month
328602|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
323221|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 left ventricular lead implant attempt
323222|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
323223|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
323224|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
323225|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
323226|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt
323227|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt
323228|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt with successful CS cannulation
323229|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode threshold captured at 0.5ms at 3-month
323230|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode threshold capture at 0.5ms at 1-month
323231|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 LV lead implant attempt
323232|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 left ventricular lead implant attempt
323233|NCT00271570|B3|Baseline|Total|Total of all reporting groups
323234|NCT00271570|B2|Baseline|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
323235|NCT00271570|B1|Baseline|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
323236|NCT00271570|P2|Participant Flow|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
323237|NCT00271570|P1|Participant Flow|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
323238|NCT00271570|O2|Outcome|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
323239|NCT00271570|O1|Outcome|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
323240|NCT00271570|O2|Outcome|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
323241|NCT00271570|O1|Outcome|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
323242|NCT00271570|E2|Reported Event|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
323243|NCT00271570|E1|Reported Event|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
323244|NCT00271596|B3|Baseline|Total|Total of all reporting groups
323245|NCT00271596|B2|Baseline|Placebo|Matching daily placebo
323246|NCT00271596|B1|Baseline|Citalopram|20mg daily citalopram
323247|NCT00271596|P2|Participant Flow|Placebo|Matching daily placebo
323248|NCT00271596|P1|Participant Flow|Citalopram|20mg daily citalopram
323249|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
323250|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
323251|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
323252|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
323253|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
323254|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
323255|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
323256|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
323257|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
323258|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
323259|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
323260|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
323261|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
323262|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
323263|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
323264|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
323265|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
323266|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
323267|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
323268|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
323269|NCT00271596|E2|Reported Event|Placebo|Matching daily placebo
323270|NCT00271596|E1|Reported Event|Citalopram|20mg daily citalopram
323271|NCT00271609|B3|Baseline|Total|Total of all reporting groups
323272|NCT00271609|B2|Baseline|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
323273|NCT00271609|B1|Baseline|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
323274|NCT00271609|P2|Participant Flow|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
323275|NCT00271609|P1|Participant Flow|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
323276|NCT00271609|O2|Outcome|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
323277|NCT00271609|O1|Outcome|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
323278|NCT00271609|O2|Outcome|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
323279|NCT00271609|O1|Outcome|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
323280|NCT00271609|E2|Reported Event|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
323281|NCT00271609|E1|Reported Event|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
323282|NCT00271739|B3|Baseline|Total|Total of all reporting groups
323283|NCT00271739|B2|Baseline|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
323284|NCT00271739|B1|Baseline|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
323285|NCT00271739|P2|Participant Flow|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
323379|NCT00272311|B2|Baseline|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
323286|NCT00271739|P1|Participant Flow|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
323287|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
323288|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
323289|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
323290|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
323291|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
323292|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
323293|NCT00271739|E2|Reported Event|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
323294|NCT00271739|E1|Reported Event|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
323295|NCT00271817|B4|Baseline|Total|Total of all reporting groups
323296|NCT00271817|B3|Baseline|Ezetimibe/Simvastatin + Niacin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.
(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
323297|NCT00271817|B2|Baseline|Ezetimibe/Simvastatin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
323298|NCT00271817|B1|Baseline|Niacin|(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg.
323299|NCT00271817|P3|Participant Flow|Ezetimibe/Simvastatin + Niacin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.
(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
323300|NCT00271817|P2|Participant Flow|Ezetimibe/Simvastatin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
323301|NCT00271817|P1|Participant Flow|Niacin|(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg. Patients in this treatment group were ramdomly reassigned for Part 2 of the study to one of two treatment groups- two-thirds of the patients enrolled in the niacin treatment group were randomly assigned to receive ezetimibe/simvastatin + niacin (ER) and the other one-third were randomly assigned to receive ezetimibe/simvastatin alone.
323302|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
323303|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
323304|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
323305|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
323306|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
323475|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
323476|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
323307|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
323308|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
323309|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
323310|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
323311|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
323312|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
323313|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
323314|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
323315|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
323316|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
323317|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
323318|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
323319|NCT00271817|O1|Outcome|Niacin|Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
323320|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
323321|NCT00271817|O1|Outcome|Niacin|Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
323322|NCT00271817|E5|Reported Event|Ezetimibe/Simvastatin + Niacin - Part 2|Ezetimibe/Simvastatin + Niacin group from Part 2 All-Treated Patient as Treated Population
323323|NCT00271817|E4|Reported Event|Ezetimibe/Simvastatin - Part 2|EZ/Simva group from Part 2 All-Treated Patient as Treated Population
323324|NCT00271817|E3|Reported Event|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin + Niacin group from Part 1
323325|NCT00271817|E2|Reported Event|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin group from Part 1
323326|NCT00271817|E1|Reported Event|Niacin|Niacin group from Part 1
323327|NCT00271856|B3|Baseline|Total|Total of all reporting groups
323328|NCT00271856|B2|Baseline|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
323329|NCT00271856|B1|Baseline|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
323330|NCT00271856|P2|Participant Flow|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
323331|NCT00271856|P1|Participant Flow|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
323332|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
323333|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
323334|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
323335|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
323336|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
323337|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
323338|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
323339|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
323340|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
323341|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
323342|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
323343|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
323344|NCT00271856|E2|Reported Event|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
323345|NCT00271856|E1|Reported Event|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
323346|NCT00271947|B1|Baseline|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
323347|NCT00271947|P1|Participant Flow|Autologous Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning regimen
323477|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
323348|NCT00271947|O1|Outcome|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
323349|NCT00271947|E1|Reported Event|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
323350|NCT00272038|B1|Baseline|Tarceva|Tarceva 150 mg QD
323351|NCT00272038|P1|Participant Flow|Tarceva|Tarceva 150 mg orally every day
323352|NCT00272038|O1|Outcome|Tarceva|Tarceva 150 mg QD
323353|NCT00272038|O1|Outcome|Tarceva|Tarceva 150 mg QD
323354|NCT00272038|O1|Outcome|Tarceva|Tarceva 150 mg QD
323355|NCT00272038|E1|Reported Event|Tarceva|Tarceva 150 mg QD
323356|NCT00272168|B3|Baseline|Total|Total of all reporting groups
323357|NCT00272168|B2|Baseline|Arm 2: Control|"Supportive Treatment for SMI (control)
Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
323358|NCT00272168|B1|Baseline|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)
Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
323380|NCT00272311|B1|Baseline|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
328603|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
323359|NCT00272168|P2|Participant Flow|Arm 2: Control|"Supportive Treatment for Serious Mental Illness (control)
Supportive Treatment for Serious Mental Illness (SMI): Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
323360|NCT00272168|P1|Participant Flow|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)
Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
323361|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)
Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
323362|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)
Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
323363|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)
Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
323364|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)
Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
323365|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)
Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
323366|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)
Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
323367|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)
Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
323368|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)
Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
323369|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)
Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
323370|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)
Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
323371|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)
Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
323372|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)
Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
323373|NCT00272168|E2|Reported Event|Arm 2: Control|"Supportive Treatment for SMI (control)
Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
323374|NCT00272168|E1|Reported Event|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)
Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
323375|NCT00272311|B6|Baseline|Total|Total of all reporting groups
323376|NCT00272311|B5|Baseline|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
323377|NCT00272311|B4|Baseline|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
323381|NCT00272311|P5|Participant Flow|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
323382|NCT00272311|P4|Participant Flow|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
323383|NCT00272311|P3|Participant Flow|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
323384|NCT00272311|P2|Participant Flow|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
323385|NCT00272311|P1|Participant Flow|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
323386|NCT00272311|O5|Outcome|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
323387|NCT00272311|O4|Outcome|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
323388|NCT00272311|O3|Outcome|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
323389|NCT00272311|O2|Outcome|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
323390|NCT00272311|O1|Outcome|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
323391|NCT00272311|E5|Reported Event|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
323392|NCT00272311|E4|Reported Event|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
323393|NCT00272311|E3|Reported Event|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
323394|NCT00272311|E2|Reported Event|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
323395|NCT00272311|E1|Reported Event|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
323396|NCT00272337|B6|Baseline|Total|Total of all reporting groups
323397|NCT00272337|B5|Baseline|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
323398|NCT00272337|B4|Baseline|4 of 5 Randomized Treatment Arms|650 mg Aspirin
323399|NCT00272337|B3|Baseline|3 of 5 Randomized Treatment Arms|325 mg Aspirin
323400|NCT00272337|B2|Baseline|2 of 5 Randomized Treatment Arms|162 mg Aspirin
323401|NCT00272337|B1|Baseline|1 of 5 Randomized Treatment Arms|81 mg Aspirin
323402|NCT00272337|P5|Participant Flow|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
323403|NCT00272337|P4|Participant Flow|4 of 5 Randomized Treatment Arms|650 mg Aspirin
323404|NCT00272337|P3|Participant Flow|3 of 5 Randomized Treatment Arms|325 mg Aspirin
323405|NCT00272337|P2|Participant Flow|2 of 5 Randomized Treatment Arms|162 mg Aspirin
323406|NCT00272337|P1|Participant Flow|1 of 5 Randomized Treatment Arms|81 mg Aspirin
323407|NCT00272337|O5|Outcome|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
323408|NCT00272337|O4|Outcome|4 of 5 Randomized Treatment Arms|650 mg Aspirin
323409|NCT00272337|O3|Outcome|3 of 5 Randomized Treatment Arms|325 mg Aspirin
323410|NCT00272337|O2|Outcome|2 of 5 Randomized Treatment Arms|162 mg Aspirin
323411|NCT00272337|O1|Outcome|1 of 5 Randomized Treatment Arms|81 mg Aspirin
323412|NCT00272337|E5|Reported Event|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
323413|NCT00272337|E4|Reported Event|4 of 5 Randomized Treatment Arms|650 mg Aspirin
323414|NCT00272337|E3|Reported Event|3 of 5 Randomized Treatment Arms|325 mg Aspirin
323415|NCT00272337|E2|Reported Event|2 of 5 Randomized Treatment Arms|162 mg Aspirin
323416|NCT00272337|E1|Reported Event|1 of 5 Randomized Treatment Arms|81 mg Aspirin
323417|NCT00278525|B3|Baseline|Total|Total of all reporting groups
323418|NCT00278525|B2|Baseline|Standard of Care|medication as standard of care will be given
323419|NCT00278525|B1|Baseline|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
323420|NCT00278525|P2|Participant Flow|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
323421|NCT00278525|P1|Participant Flow|Standard of Care|Cyclophosphamide will be given as approved immunosuppressive therapy
323422|NCT00278525|O2|Outcome|Standard of Care|Intravenous (IV) will be given 1000 mg/m2 cyclophosphamide monthly for 6 months.
323423|NCT00278525|O1|Outcome|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
323424|NCT00278525|O2|Outcome|Standard of Care|Intravenous (IV) will be given 1000 mg/m2 cyclophosphamide monthly for 6 months.
323425|NCT00278525|O1|Outcome|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
323426|NCT00278525|E2|Reported Event|Standard of Care|medication as standard of care will be given
323427|NCT00278525|E1|Reported Event|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
323478|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
323479|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
323428|NCT00278655|B1|Baseline|Stem Cell Transplantation|"All participants will undergo stem cell transplantation after receiving conditioning regimen.
hematopoietic stem cell transplantation : Autologous hematopoietic stem cell transplantation"
323429|NCT00278655|P1|Participant Flow|Autologous Hematopoietic Stem Cell Transplantation|Patient's own blood stem cells collected after mobilization with cyclophosphamide (2.0 gm/m²)and granulocyte colony-stimulating factor (G-CSF) (5-10mcg/kg/day.Collected stem cells given back to the patient after receiving conditioning regimen (Cyclophosphamide 50 mg/kg/day for four days and either 20 mg alemtuzumab or 6mg/kg rabbit antithymocyte globulin.
323430|NCT00278655|O1|Outcome|Autologous Hematopoietic Stem Cell Transplantation|Patient's own blood stem cells collected after mobilization with cyclophosphamide (2.0 gm/m²)and G-CSF (5-10 mcg/kg/day.Collected stem cells given back to the patient after receiving conditioning regimen (Cyclophosphamide 50 mg/kg/day for four days and either 20 mg alemtuzumab or 6mg/kg rabbit antithymocyte globulin.
323431|NCT00278655|O1|Outcome|Stem Cell Transplantation|Autologous hematopoietic stem cell transplantation Peripheral blood stem cells were mobilised with 2g per square m intravenous (IV) cyclophosphamide (CY) followed by 10 µg per kg subcutaneous filgrastim daily from day 5. After neutrophil recovery, the mobilised cells were collected by apheresis. The recovered cells were unselected and cryopreserved. There was at least three weeks between mobilisation and the conditioning regimen. The conditioning regimen used was 200 mg per kg intravenous CY , given in four equal fractions between day -5 and day -2 with IV mesna, and one 20mg dose of IV alemtuzumab (CAMPATH-1H) given on day -2 with 250 mg intravenous methyl-prednisolone as premedication. Alemtuzumab was changed to rabbit antithymocyte globulin rATG) in the last 4 patients, who received 6 mg per kg rATG over 5 days instead of alemtuzumab . Stem cells wer reinfused 36 h after completion of CY. 5 µg/kg/day filgrastim was given from day 5 until neutrophil recovery.
323594|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323432|NCT00278655|E1|Reported Event|Stem Cell Transplantation|"All participants will undergo stem cell transplantation after receiving conditioning regimen.
hematopoietic stem cell transplantation : Autologous hematopoietic stem cell transplantation"
323433|NCT00282815|B3|Baseline|Total|Total of all reporting groups
323434|NCT00282815|B2|Baseline|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
323435|NCT00282815|B1|Baseline|Active Continuous Positive Airway Pressure (CPAP)|
323436|NCT00282815|P2|Participant Flow|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
323437|NCT00282815|P1|Participant Flow|Active Continuous Positive Airway Pressure (CPAP)|
323438|NCT00282815|O2|Outcome|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
323439|NCT00282815|O1|Outcome|Active Continuous Positive Airway Pressure (CPAP)|
323440|NCT00282815|O1|Outcome|After Randomization|
323441|NCT00282815|O2|Outcome|Sham CPAP|
323442|NCT00282815|O1|Outcome|Active CPAP|
323443|NCT00282815|E2|Reported Event|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
323444|NCT00282815|E1|Reported Event|Active Continuous Positive Airway Pressure (CPAP)|
323445|NCT00282828|B4|Baseline|Total|Total of all reporting groups
323446|NCT00282828|B3|Baseline|Sertraline and Placebo|Participants will take both sertraline and placebo
323447|NCT00282828|B2|Baseline|Venlafaxine|Participants will take venlafaxine only
323448|NCT00282828|B1|Baseline|Sertraline and Clonazepam|Participants will take both sertraline and clonazepam
323449|NCT00282828|P3|Participant Flow|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
323450|NCT00282828|P2|Participant Flow|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
323451|NCT00282828|P1|Participant Flow|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
323452|NCT00282828|O3|Outcome|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
323453|NCT00282828|O2|Outcome|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
323454|NCT00282828|O1|Outcome|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
323455|NCT00282828|O3|Outcome|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
323456|NCT00282828|O2|Outcome|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
323457|NCT00282828|O1|Outcome|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
323458|NCT00282828|E3|Reported Event|Sertraline and Placebo|Participants will take both sertraline and placebo
323459|NCT00282828|E2|Reported Event|Venlafaxine|Participants will take venlafaxine only
323460|NCT00282828|E1|Reported Event|Sertraline and Clonazepam|Participants will take both sertraline and clonazepam
323461|NCT00282867|B4|Baseline|Total|Total of all reporting groups
323462|NCT00282867|B3|Baseline|Usual Care Group|target level 70 - 300 mg/dL
323463|NCT00282867|B2|Baseline|Loose Control Group|target glucose level 70 – 200 mg/dL
323464|NCT00282867|B1|Baseline|Tight Control Group|target glucose level 70-110 mg/dL
323465|NCT00282867|P3|Participant Flow|Usual Care Group|target level 70 - 300 mg/dL
323466|NCT00282867|P2|Participant Flow|Loose Control Group|target glucose level 70 – 200 mg/dL
323467|NCT00282867|P1|Participant Flow|Tight Control Group|target glucose level 70-110 mg/dL
323468|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
323469|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
323470|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
323471|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
323472|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
323473|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
323474|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
323480|NCT00282919|B1|Baseline|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323481|NCT00282919|P1|Participant Flow|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323482|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323483|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323484|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323485|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323634|NCT00283244|E3|Reported Event|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
323486|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323487|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323488|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323489|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323490|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323491|NCT00282919|E1|Reported Event|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
323492|NCT00282971|B3|Baseline|Total|Total of all reporting groups
323493|NCT00282971|B2|Baseline|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
323494|NCT00282971|B1|Baseline|Inhaled Insulin|Inhaled insulin plus oral therapy
323495|NCT00282971|P2|Participant Flow|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
323496|NCT00282971|P1|Participant Flow|Inhaled Insulin|Inhaled insulin plus oral therapy
323497|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
323498|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
323499|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
323500|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
323501|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
323502|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
323503|NCT00282971|E2|Reported Event|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
323504|NCT00282971|E1|Reported Event|Inhaled Insulin|Inhaled insulin plus oral therapy
323505|NCT00282984|B3|Baseline|Total|Total of all reporting groups
323506|NCT00282984|B2|Baseline|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323507|NCT00282984|B1|Baseline|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323508|NCT00282984|P2|Participant Flow|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323509|NCT00282984|P1|Participant Flow|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323510|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323511|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323512|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323513|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323514|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323515|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323516|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323517|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323518|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323519|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323520|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
328604|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
323521|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323522|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323523|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323524|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323525|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323526|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323527|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323528|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323529|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323530|NCT00282984|E2|Reported Event|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323531|NCT00282984|E1|Reported Event|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
323532|NCT00283049|B4|Baseline|Total|Total of all reporting groups
323533|NCT00283049|B3|Baseline|MET+SU + IG|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
323534|NCT00283049|B2|Baseline|MET + TZD + IG|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a thiazolidinedione (TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
323535|NCT00283049|B1|Baseline|SU + TZD + IG|Arm 1: Insulin glargine(IG) administered subcutaneously once daily plus a sulfonylurea and a thiazolidinedione(TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
323536|NCT00283049|P3|Participant Flow|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323537|NCT00283049|P2|Participant Flow|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323538|NCT00283049|P1|Participant Flow|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323539|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323540|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323623|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
323541|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323542|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323543|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323544|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323545|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323546|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323547|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323548|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323549|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323550|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323551|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323552|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323553|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323554|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323555|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323556|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323557|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323558|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323559|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323560|NCT00283049|E3|Reported Event|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323561|NCT00283049|E2|Reported Event|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323562|NCT00283049|E1|Reported Event|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
323563|NCT00283062|B5|Baseline|Total|Total of all reporting groups
323564|NCT00283062|B4|Baseline|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
323674|NCT00283400|E1|Reported Event|Dosage Tier 1|25% human albumin 0.625 g/kg
323565|NCT00283062|B3|Baseline|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
323566|NCT00283062|B2|Baseline|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323567|NCT00283062|B1|Baseline|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323568|NCT00283062|P4|Participant Flow|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
323569|NCT00283062|P3|Participant Flow|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
323570|NCT00283062|P2|Participant Flow|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323571|NCT00283062|P1|Participant Flow|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323572|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
323573|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
323574|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323575|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323576|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
323577|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
323578|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323579|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323580|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
323581|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
323582|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323583|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323584|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
323585|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
323586|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323587|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323622|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
323588|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
323589|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
323590|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323591|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323592|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
323593|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
328605|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
323595|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323596|NCT00283062|E4|Reported Event|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
323597|NCT00283062|E3|Reported Event|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
323598|NCT00283062|E2|Reported Event|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323599|NCT00283062|E1|Reported Event|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
323600|NCT00283075|B1|Baseline|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
323601|NCT00283075|P2|Participant Flow|16 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.
323602|NCT00283075|P1|Participant Flow|8 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
323603|NCT00283075|O2|Outcome|16 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.
323604|NCT00283075|O1|Outcome|8 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
323605|NCT00283075|O4|Outcome|Day 28|Tumor marker response at Day 28 after the first implantation.
323606|NCT00283075|O3|Outcome|Day 21|Tumor marker response at Day 21 after the first implantation.
323607|NCT00283075|O2|Outcome|Day 14|Tumor marker response at Day 14 after the first implantation.
323608|NCT00283075|O1|Outcome|Day 7|Tumor marker response at Day 7 after the first implantation.
323609|NCT00283075|O1|Outcome|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
323610|NCT00283075|O1|Outcome|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
323611|NCT00283075|E1|Reported Event|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
323612|NCT00283244|B4|Baseline|Total|Total of all reporting groups
323613|NCT00283244|B3|Baseline|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
323614|NCT00283244|B2|Baseline|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
323615|NCT00283244|B1|Baseline|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
323616|NCT00283244|P3|Participant Flow|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
323617|NCT00283244|P2|Participant Flow|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
323618|NCT00283244|P1|Participant Flow|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
323619|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
323620|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
323621|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
323624|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
323625|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
323626|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
323627|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
323628|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
323629|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
323630|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
323631|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
323632|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21
323633|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
328606|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
323635|NCT00283244|E2|Reported Event|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
323636|NCT00283244|E1|Reported Event|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
323637|NCT00283296|B1|Baseline|Endeavor Wheelchair|Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
323638|NCT00283296|P1|Participant Flow|Endeavor Wheelchair|All participants completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair three times each. Testing was completed during a one-day visit that did not exceed 2 1/2 hours. For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
323639|NCT00283296|O1|Outcome|Endeavor Wheelchair|For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
323640|NCT00283296|O1|Outcome|Endeavor Wheelchair|For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
323641|NCT00283296|O1|Outcome|Endeavor Wheelchair|All participants received an introduction to the Endeavor wheelchair, and completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
323642|NCT00283296|E1|Reported Event|Endeavor Wheelchair|Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
323643|NCT00283387|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and betaine first.
323644|NCT00283387|P2|Participant Flow|Placebo First, Then Betaine|Subjects received oral lactose placebo divided in two doses daily, for 2 months, followed by a 2 month washout period. Subjects then received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
323645|NCT00283387|P1|Participant Flow|Betaine First, Then Placebo|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old) divided in two doses daily, for 2 months, followed by a 2 month washout period. Subjects then received oral lactose placebo divided in two doses daily, for 2 months.
323646|NCT00283387|O2|Outcome|Placebo|Subjects received oral lactose placebo divided in two doses daily, for 2 months.
323647|NCT00283387|O1|Outcome|Betaine|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
323648|NCT00283387|E2|Reported Event|Placebo|Subjects received oral lactose placebo divided in two doses daily, for 2 months.
323649|NCT00283387|E1|Reported Event|Betaine|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
323650|NCT00283400|B5|Baseline|Total|Total of all reporting groups
323651|NCT00283400|B4|Baseline|Dosage Tier 4|25% human albumin 2.5 g/kg
323652|NCT00283400|B3|Baseline|Dosage Tier 3|25% human albumin 1.875 g/kg
323653|NCT00283400|B2|Baseline|Dosage Tier 2|25% human albumin 1.25 g/kg
323654|NCT00283400|B1|Baseline|Dosage Tier 1|25% human albumin 0.625 g/kg
323655|NCT00283400|P4|Participant Flow|Dosage Tier 4|25% human albumin2.5 g/kg
323656|NCT00283400|P3|Participant Flow|Dosage Tier 3|25% human albumin 1.875 g/kg
323657|NCT00283400|P2|Participant Flow|Dosage Tier 2|25% human albumin 1.25 g/kg
323658|NCT00283400|P1|Participant Flow|Dosage Tier 1|25% human albumin 0.625 g/kg
323659|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
323660|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
323661|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
323662|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
323663|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
323664|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
323665|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
323666|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
323667|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
323668|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
323669|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
323670|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
323671|NCT00283400|E4|Reported Event|Dosage Tier 4|25% human albumin 2.5 g/kg
323672|NCT00283400|E3|Reported Event|Dosage Tier 3|25% human albumin 1.875 g/kg
323673|NCT00283400|E2|Reported Event|Dosage Tier 2|25% human albumin 1.25 g/kg
323676|NCT00283439|B4|Baseline|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
323677|NCT00283439|B3|Baseline|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
323678|NCT00283439|B2|Baseline|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
323679|NCT00283439|B1|Baseline|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
323680|NCT00283439|P4|Participant Flow|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
323681|NCT00283439|P3|Participant Flow|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
323682|NCT00283439|P2|Participant Flow|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
323683|NCT00283439|P1|Participant Flow|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
323684|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
323685|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
323686|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
323687|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
323688|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
323689|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
323690|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
323691|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
323692|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
323693|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
323694|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
323695|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
323696|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
323697|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
323698|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
323699|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
323700|NCT00283439|E4|Reported Event|Romiplostim 1000 µg|
323701|NCT00283439|E3|Reported Event|Romiplostim 700 µg|
323702|NCT00283439|E2|Reported Event|Romiplostim 300 µg|
323703|NCT00283439|E1|Reported Event|Romiplostim 100 µg|
323704|NCT00283595|B3|Baseline|Total|Total of all reporting groups
323705|NCT00283595|B2|Baseline|Placebo Group|Treatment with Placebo
323706|NCT00283595|B1|Baseline|Recombinant Human Growth Hormone Group|Treatment with rHGH
323707|NCT00283595|P2|Participant Flow|Placebo (Subcutaneous Daily Injection)|Treatment with Placebo
323708|NCT00283595|P1|Participant Flow|Recombinant Human Growth Hormone(Subcutaneous Daily Injection)|Treatment with rHGH
323709|NCT00283595|O2|Outcome|Placebo Group|Treatment with Placebo
323710|NCT00283595|O1|Outcome|Recombinant Human Growth Hormone Group|Treatment with rHGH
323711|NCT00283595|O2|Outcome|Placebo Group|Treatment with Placebo
323712|NCT00283595|O1|Outcome|Recombinant Human Growth Hormone Group|Treatment with rHGH
323713|NCT00283595|E2|Reported Event|Placebo Group|Treatment with Placebo
323714|NCT00283595|E1|Reported Event|Recombinant Human Growth Hormone Group|Treatment with rHGH
323715|NCT00283686|B5|Baseline|Total|Total of all reporting groups
323716|NCT00283686|B4|Baseline|ACE-I/Placebo and Low BP|"ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
323717|NCT00283686|B3|Baseline|ACE-I/Placebo and Standard BP|"ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
323718|NCT00283686|B2|Baseline|ACE-I/ARB and Low BP|"ACE-I + ARB and low blood pressure control of 95-110/60-75 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
323719|NCT00283686|B1|Baseline|ACE-I/ARB and Standard BP|"ACE-I + ARB and standard blood pressure control of 120-130/70-80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
323720|NCT00283686|P4|Participant Flow|ACE-I/Placebo and Low BP|"ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
323721|NCT00283686|P3|Participant Flow|ACE-I/Placebo and Standard BP|"ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg
Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
325631|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
323722|NCT00283686|P2|Participant Flow|ACE-I/ARB and Low BP|"ACE-I + angiotensin-receptor blocker (ARB) and low blood pressure control of 95-110/60-75 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
323723|NCT00283686|P1|Participant Flow|ACE-I/ARB and Standard BP|"ACE-I + angiotensin-receptor blocker (ARB) and standard blood pressure control of 120-130/70-80 mm Hg
Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
323724|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
323725|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
323726|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
323727|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
323728|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
323729|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
323730|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
323731|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
328607|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
323732|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
323733|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
323734|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
323735|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
323736|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
323737|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
323738|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
323739|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
323740|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
323741|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
323742|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
323743|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
323744|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
323745|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
323746|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
323747|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
323748|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
323749|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
323750|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
323751|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
323752|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
323753|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
323754|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
323755|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
323756|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
323757|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
323758|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
323759|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
323760|NCT00283686|E4|Reported Event|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
323761|NCT00283686|E3|Reported Event|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
323762|NCT00283686|E2|Reported Event|ACE-I Alone|ACE-I monotherapy (lisinopril only)
323763|NCT00283686|E1|Reported Event|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
323764|NCT00283712|B3|Baseline|Total|Total of all reporting groups
323765|NCT00283712|B2|Baseline|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323766|NCT00283712|B1|Baseline|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323767|NCT00283712|P2|Participant Flow|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323768|NCT00283712|P1|Participant Flow|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323818|NCT00283842|B4|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
324084|NCT00275262|B2|Baseline|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
323769|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323770|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323771|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323772|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323830|NCT00283842|O2|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323831|NCT00283842|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323773|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323774|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323775|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323776|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323777|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323778|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323779|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323780|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323781|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323782|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323783|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323784|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323785|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323786|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323787|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323788|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323789|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323790|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323791|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323792|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323793|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323794|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323795|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323796|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323797|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323798|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
323799|NCT00283712|E2|Reported Event|Placebo|Subjects randomized to the Placebo group
323800|NCT00283712|E1|Reported Event|Infliximab|Subjects randomized to the Infliximab group
323801|NCT00283816|B3|Baseline|Total|Total of all reporting groups
323802|NCT00283816|B2|Baseline|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
323803|NCT00283816|B1|Baseline|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
323804|NCT00283816|P2|Participant Flow|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
323805|NCT00283816|P1|Participant Flow|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
323806|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
323807|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
323808|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
323809|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
323810|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive
323811|NCT00283816|O1|Outcome|Metformin|metformin 2000mg in addition to oral contraceptive
323812|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
323813|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
323814|NCT00283816|E2|Reported Event|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
323815|NCT00283816|E1|Reported Event|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
323819|NCT00283842|B3|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323820|NCT00283842|B2|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323821|NCT00283842|B1|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323822|NCT00283842|P5|Participant Flow|Placebo|
323823|NCT00283842|P4|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323824|NCT00283842|P3|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323825|NCT00283842|P2|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323826|NCT00283842|P1|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323827|NCT00283842|O5|Outcome|Placebo|
323828|NCT00283842|O4|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323829|NCT00283842|O3|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323833|NCT00283842|O4|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323834|NCT00283842|O3|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323835|NCT00283842|O2|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323836|NCT00283842|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323837|NCT00283842|E5|Reported Event|Placebo|
323838|NCT00283842|E4|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323839|NCT00283842|E3|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323840|NCT00283842|E2|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323841|NCT00283842|E1|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
323842|NCT00283868|B3|Baseline|Total|Total of all reporting groups
323843|NCT00283868|B2|Baseline|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
323844|NCT00283868|B1|Baseline|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
323845|NCT00283868|P2|Participant Flow|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
323846|NCT00283868|P1|Participant Flow|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
323847|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
323848|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
323849|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
323850|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
323851|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
323852|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
323853|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
323854|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
323855|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
323856|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
323857|NCT00284050|B4|Baseline|Total|Total of all reporting groups
323858|NCT00284050|B3|Baseline|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323859|NCT00284050|B2|Baseline|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323937|NCT00284180|B1|Baseline|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
324021|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
323860|NCT00284050|B1|Baseline|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323861|NCT00284050|P3|Participant Flow|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323862|NCT00284050|P2|Participant Flow|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323893|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323957|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
323863|NCT00284050|P1|Participant Flow|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323864|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323865|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323866|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323867|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323868|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323869|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323870|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323871|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323938|NCT00284180|P2|Participant Flow|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
324246|NCT00285818|B3|Baseline|Total|Total of all reporting groups
323872|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323873|NCT00284050|E3|Reported Event|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323874|NCT00284050|E2|Reported Event|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323875|NCT00284050|E1|Reported Event|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
323876|NCT00284089|B5|Baseline|Total|Total of all reporting groups
328608|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
323877|NCT00284089|B4|Baseline|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
323878|NCT00284089|B3|Baseline|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
323879|NCT00284089|B2|Baseline|Group A: Ranibizumab 0.5 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months. Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years.
323880|NCT00284089|B1|Baseline|Group A: Ranibizumab 0.3 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months. Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years.
323881|NCT00284089|P4|Participant Flow|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
323882|NCT00284089|P3|Participant Flow|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
323883|NCT00284089|P2|Participant Flow|Group A: Ranibizumab 0.5 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months. Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years.
323939|NCT00284180|P1|Participant Flow|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
325632|NCT00279591|O2|Outcome|Control Group|
323884|NCT00284089|P1|Participant Flow|Group A: Ranibizumab 0.3 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months. Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years.
323885|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323886|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323887|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323888|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323889|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323890|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323891|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323892|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323956|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
323894|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323895|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
323896|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
323897|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
323898|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
323899|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323900|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323901|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323902|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323903|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323904|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
323905|NCT00284089|E4|Reported Event|Extension Group A+B: Ranibizumab 0.5 mg|In the extension phase, all patients received an intravitreal injection of 0.5 mg ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
324019|NCT00284856|P1|Participant Flow|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324365|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
323906|NCT00284089|E3|Reported Event|Extension Group A+B: Ranibizumab 0.3 mg|In the extension phase, enrolled patients received an intravitreal injection of 0.3 mg ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
323907|NCT00284089|E2|Reported Event|Core Group A+B: Ranibizumab 0.5 mg|“Core” means Single and Multiple Dose Phases. Group A patients received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye, followed by 11 additional intravitreal injections of 0.5 mg of ranibizumab once a month. Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye.
323908|NCT00284089|E1|Reported Event|Core Group A+B: Ranibizumab 0.3 mg|“Core” means Single and Multiple Dose Phases. Group A patients received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye, followed by 11 additional intravitreal injections of 0.3 mg of ranibizumab once a month. Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye.
323909|NCT00284141|B1|Baseline|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
323910|NCT00284141|P1|Participant Flow|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
323911|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
323912|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
323913|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
323914|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
323915|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
323916|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
323917|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
323918|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
323919|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
323920|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
323921|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
323922|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
323923|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
323924|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
323925|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
323926|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
323927|NCT00284141|E1|Reported Event|4 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
323928|NCT00284154|B1|Baseline|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
323929|NCT00284154|P1|Participant Flow|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
323930|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
323931|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
323932|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
323933|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
323934|NCT00284154|E1|Reported Event|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
323935|NCT00284180|B3|Baseline|Total|Total of all reporting groups
323936|NCT00284180|B2|Baseline|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
325633|NCT00279591|O1|Outcome|Intervention Group|
323940|NCT00284180|O2|Outcome|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2
323941|NCT00284180|O1|Outcome|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
323942|NCT00284180|E2|Reported Event|Vinflunine/Trastuzumab|
323943|NCT00284180|E1|Reported Event|Vinflunine|
323944|NCT00284518|B5|Baseline|Total|Total of all reporting groups
323945|NCT00284518|B4|Baseline|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
323946|NCT00284518|B3|Baseline|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
323947|NCT00284518|B2|Baseline|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
323948|NCT00284518|B1|Baseline|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
323949|NCT00284518|P4|Participant Flow|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
323950|NCT00284518|P3|Participant Flow|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
323951|NCT00284518|P2|Participant Flow|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
323952|NCT00284518|P1|Participant Flow|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
323953|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
323954|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
323955|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
323958|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
323959|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
323960|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
323961|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
323962|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
323963|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
323964|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
323965|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
323966|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
323967|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
323968|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
323969|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
323970|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
323971|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
323972|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
323973|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
323974|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
323975|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
323976|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
323977|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
323978|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
323979|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
323980|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
323981|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
323982|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
323983|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
323984|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
323985|NCT00284518|E4|Reported Event|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
323986|NCT00284518|E3|Reported Event|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
323987|NCT00284518|E2|Reported Event|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
323988|NCT00284518|E1|Reported Event|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
323989|NCT00284557|B3|Baseline|Total|Total of all reporting groups
324020|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324366|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
323990|NCT00284557|B2|Baseline|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
323991|NCT00284557|B1|Baseline|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
323992|NCT00284557|P2|Participant Flow|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
323993|NCT00284557|P1|Participant Flow|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
323994|NCT00284557|O2|Outcome|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
323995|NCT00284557|O1|Outcome|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
324138|NCT00275561|P2|Participant Flow|Placebo|Placebo inhaler swallowed bid for 6 weeks
323996|NCT00284557|O2|Outcome|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
323997|NCT00284557|O1|Outcome|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
323998|NCT00284557|E2|Reported Event|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
323999|NCT00284557|E1|Reported Event|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
324000|NCT00284739|B3|Baseline|Total|Total of all reporting groups
324001|NCT00284739|B2|Baseline|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
324002|NCT00284739|B1|Baseline|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
324003|NCT00284739|P2|Participant Flow|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
324004|NCT00284739|P1|Participant Flow|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
324005|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
324006|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
324007|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
324008|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
324009|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
324010|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
324011|NCT00284739|E2|Reported Event|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
324012|NCT00284739|E1|Reported Event|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
324013|NCT00284856|B4|Baseline|Total|Total of all reporting groups
324014|NCT00284856|B3|Baseline|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324015|NCT00284856|B2|Baseline|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
324016|NCT00284856|B1|Baseline|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324017|NCT00284856|P3|Participant Flow|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324018|NCT00284856|P2|Participant Flow|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
325634|NCT00279591|O2|Outcome|Control Group|
324022|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324023|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324024|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
324025|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324026|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324027|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
324028|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324029|NCT00284856|E3|Reported Event|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324030|NCT00284856|E2|Reported Event|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
324031|NCT00284856|E1|Reported Event|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
324032|NCT00284934|B3|Baseline|Total|Total of all reporting groups
324048|NCT00285012|B2|Baseline|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324094|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
324033|NCT00284934|B2|Baseline|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324034|NCT00284934|B1|Baseline|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324035|NCT00284934|P2|Participant Flow|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324036|NCT00284934|P1|Participant Flow|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324037|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324038|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324039|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324040|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324041|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324073|NCT00285012|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324074|NCT00285207|B3|Baseline|Total|Total of all reporting groups
324075|NCT00285207|B2|Baseline|A007|Experimental A007
324076|NCT00285207|B1|Baseline|Placebo|Placebo (no treatment)
324042|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324043|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324044|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324045|NCT00284934|E2|Reported Event|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324046|NCT00284934|E1|Reported Event|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
324047|NCT00285012|B3|Baseline|Total|Total of all reporting groups
324049|NCT00285012|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324050|NCT00285012|P2|Participant Flow|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324051|NCT00285012|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324052|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324053|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324054|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324055|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324056|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324057|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324058|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324059|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324060|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324061|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324062|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324063|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324064|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324065|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324066|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324067|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324068|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324069|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324070|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324071|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324072|NCT00285012|E2|Reported Event|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
324077|NCT00285207|P2|Participant Flow|A007|Experimental A007
324078|NCT00285207|P1|Participant Flow|Placebo|Placebo (no treatment)
324085|NCT00275262|B1|Baseline|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
324086|NCT00275262|P2|Participant Flow|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
324087|NCT00275262|P1|Participant Flow|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
324088|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
324089|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
324090|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
324091|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
324092|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
324093|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
328609|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
324095|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
324096|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
324097|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
324098|NCT00275262|E2|Reported Event|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
324099|NCT00275262|E1|Reported Event|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
324100|NCT00275275|B4|Baseline|Total|Total of all reporting groups
324101|NCT00275275|B3|Baseline|Mirapex to Requip 24-Hour of 1:5|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
324102|NCT00275275|B2|Baseline|Mirapex to Requip 24-Hour of 1:4|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
324103|NCT00275275|B1|Baseline|Mirapex to Requip 24-Hour of 1:3|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
324104|NCT00275275|P3|Participant Flow|Mirapex to Requip 24-Hour of 1:5|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
324105|NCT00275275|P2|Participant Flow|Mirapex to Requip 24-Hour of 1:4|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
324106|NCT00275275|P1|Participant Flow|Mirapex to Requip 24-Hour of 1:3|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
324107|NCT00275275|O2|Outcome|Preferred Mirapex|This is the group that preferred Mirapex to Requip PR
324108|NCT00275275|O1|Outcome|Preferred Requip PR|This is the group of subjects that preferred Requip PR to Mirapex
324109|NCT00275275|O2|Outcome|Preferred Mirapex|This group refers to the subjects that preferred Mirapex
324110|NCT00275275|O1|Outcome|Preferred Requip PR|This group refers to the subjects that preferred Requip PR to Mirapex
324111|NCT00275275|E2|Reported Event|Preferred Mirapex|These are the subjects that preferred Mirapex to Requip PR at the end of the study
324112|NCT00275275|E1|Reported Event|Preferred Requip PR|These are the subjects that preferred Requip PR to Mirapex at the end of the study
324113|NCT00275301|B1|Baseline|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
324114|NCT00275301|P1|Participant Flow|All Subjects Took Open-label Olanzapine.|All subjects took open-label olanzapine. Subjects tritrated to up to 10mg
324115|NCT00275301|O1|Outcome|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
324116|NCT00275301|E1|Reported Event|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
324117|NCT00275340|B3|Baseline|Total|Total of all reporting groups
324118|NCT00275340|B2|Baseline|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
324119|NCT00275340|B1|Baseline|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
324120|NCT00275340|P2|Participant Flow|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
324121|NCT00275340|P1|Participant Flow|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
324122|NCT00275340|O2|Outcome|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
324123|NCT00275340|O1|Outcome|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
324124|NCT00275392|B3|Baseline|Total|Total of all reporting groups
324125|NCT00275392|B2|Baseline|Placebo|"placebo exercises plus standard balance and gait exercises
Placebo Vestibular rehabilitation: placebo vestibular exercises"
324126|NCT00275392|B1|Baseline|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises
Vestibular rehabilitation: vestibular adaptation and substitution exercises"
324127|NCT00275392|P2|Participant Flow|Placebo|"placebo exercises plus standard balance and gait exercises
Placebo Vestibular rehabilitation: placebo vestibular exercises"
324128|NCT00275392|P1|Participant Flow|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises
Vestibular rehabilitation: vestibular adaptation and substitution exercises"
324129|NCT00275392|O2|Outcome|Placebo|"placebo exercises plus standard balance and gait exercises
Placebo Vestibular rehabilitation: placebo vestibular exercises"
324130|NCT00275392|O1|Outcome|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises
Vestibular rehabilitation: vestibular adaptation and substitution exercises"
324131|NCT00275392|O2|Outcome|Placebo|"placebo exercises plus standard balance and gait exercises
Placebo Vestibular rehabilitation: placebo vestibular exercises"
324132|NCT00275392|O1|Outcome|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises
Vestibular rehabilitation: vestibular adaptation and substitution exercises"
324133|NCT00275392|E2|Reported Event|Placebo|"placebo exercises plus standard balance and gait exercises
Placebo Vestibular rehabilitation: placebo vestibular exercises"
324134|NCT00275392|E1|Reported Event|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises
Vestibular rehabilitation: vestibular adaptation and substitution exercises"
324135|NCT00275561|B3|Baseline|Total|Total of all reporting groups
324136|NCT00275561|B2|Baseline|Placebo|Placebo inhaler swallowed bid for 6 weeks
324137|NCT00275561|B1|Baseline|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
324139|NCT00275561|P1|Participant Flow|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
324140|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
324141|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
324142|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
324143|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
324144|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
324145|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
324146|NCT00275561|E2|Reported Event|Placebo|Placebo inhaler swallowed bid for 6 weeks
324147|NCT00275561|E1|Reported Event|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
324148|NCT00275821|B4|Baseline|Total|Total of all reporting groups
324149|NCT00275821|B3|Baseline|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324150|NCT00275821|B2|Baseline|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324151|NCT00275821|B1|Baseline|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324152|NCT00275821|P3|Participant Flow|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324153|NCT00275821|P2|Participant Flow|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324154|NCT00275821|P1|Participant Flow|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324155|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324156|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324157|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324158|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324159|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324247|NCT00285818|B2|Baseline|Placebo|"Patients receive a placebo pill one day before and for 5 additional days after starting ECT
Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
324367|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324160|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324161|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324162|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324163|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324164|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324326|NCT00286429|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324165|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324166|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324167|NCT00275821|E3|Reported Event|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324168|NCT00275821|E2|Reported Event|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324169|NCT00275821|E1|Reported Event|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
324170|NCT00275834|B4|Baseline|Total|Total of all reporting groups
324171|NCT00275834|B3|Baseline|Zonisamide 400 mg|
324172|NCT00275834|B2|Baseline|Zonisamide 200 mg|
324173|NCT00275834|B1|Baseline|Placebo|
324174|NCT00275834|P3|Participant Flow|Zonisamide 400 mg|
324175|NCT00275834|P2|Participant Flow|Zonisamide 200 mg|Dosing of matching placebo was identical.
324176|NCT00275834|P1|Participant Flow|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.
Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
324177|NCT00275834|O3|Outcome|Zonisamide 400 mg|
324178|NCT00275834|O2|Outcome|Zonisamide 200 mg|Dosing of matching placebo was identical.
324179|NCT00275834|O1|Outcome|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.
Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
324180|NCT00275834|O3|Outcome|Zonisamide 400 mg|
324181|NCT00275834|O2|Outcome|Zonisamide 200 mg|
324182|NCT00275834|O1|Outcome|Placebo|
324183|NCT00275834|O3|Outcome|Zonisamide 400 mg|
324184|NCT00275834|O2|Outcome|Zonisamide 200 mg|Dosing of matching placebo was identical.
324248|NCT00285818|B1|Baseline|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT
Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
324249|NCT00285818|P2|Participant Flow|Placebo|"Patients receive a placebo capsule one day before and for 5 additional days after starting ECT
Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
324368|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324185|NCT00275834|O1|Outcome|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.
Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
324186|NCT00275834|O3|Outcome|Zonisamide 400 mg|
324187|NCT00275834|O2|Outcome|Zonisamide 200 mg|
324188|NCT00275834|O1|Outcome|Placebo|
324189|NCT00275834|O3|Outcome|Zonisamide 400 mg|
324190|NCT00275834|O2|Outcome|Zonisamide 200 mg|
324191|NCT00275834|O1|Outcome|Placebo|
324192|NCT00275834|O3|Outcome|Zonisamide 400 mg|
324193|NCT00275834|O2|Outcome|Zonisamide 200 mg|
324194|NCT00275834|O1|Outcome|Placebo|
324195|NCT00275834|O3|Outcome|Zonisamide 400 mg|
324196|NCT00275834|O2|Outcome|Zonisamide 200 mg|
324197|NCT00275834|O1|Outcome|Placebo|
324198|NCT00275834|O3|Outcome|Zonisamide 400 mg|
324199|NCT00275834|O2|Outcome|Zonisamide 200 mg|
324200|NCT00275834|O1|Outcome|Placebo|
324201|NCT00275834|E3|Reported Event|Zonisamide 400 mg|
324202|NCT00275834|E2|Reported Event|Zonisamide 200 mg|
324203|NCT00275834|E1|Reported Event|Placebo|
324204|NCT00285246|B1|Baseline|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
324205|NCT00285246|P1|Participant Flow|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
324206|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
328610|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
324207|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
324208|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
324209|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
324210|NCT00285246|E1|Reported Event|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
324211|NCT00285467|B3|Baseline|Total|Total of all reporting groups
324212|NCT00285467|B2|Baseline|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
324213|NCT00285467|B1|Baseline|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
324214|NCT00285467|P2|Participant Flow|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
324215|NCT00285467|P1|Participant Flow|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
324216|NCT00285467|O2|Outcome|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
324217|NCT00285467|O1|Outcome|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
324218|NCT00285467|O2|Outcome|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
324219|NCT00285467|O1|Outcome|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
324220|NCT00285467|E2|Reported Event|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
324221|NCT00285467|E1|Reported Event|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
324222|NCT00285584|B3|Baseline|Total|Total of all reporting groups
324223|NCT00285584|B2|Baseline|Placebo|Participants in this arm received placebo.
324224|NCT00285584|B1|Baseline|Bupropion|Participants in this arm received bupropion.
324225|NCT00285584|P2|Participant Flow|Placebo|Participants in this arm received placebo.
324226|NCT00285584|P1|Participant Flow|Bupropion|Participants in this arm received bupropion.
324227|NCT00285584|O2|Outcome|Placebo|
324228|NCT00285584|O1|Outcome|Bupropion|
324229|NCT00285584|O2|Outcome|Placebo|Participants in this arm received placebo.
324230|NCT00285584|O1|Outcome|Bupropion|Participants in this arm received bupropion.
324231|NCT00285584|O2|Outcome|Placebo|
324232|NCT00285584|O1|Outcome|Bupropion|
324233|NCT00285584|O2|Outcome|Placebo|6 months
324234|NCT00285584|O1|Outcome|Bupropion|6 months
324235|NCT00285584|E2|Reported Event|Placebo|Participants in this arm received placebo.
324236|NCT00285584|E1|Reported Event|Bupropion|Participants in this arm received bupropion.
324237|NCT00285779|B3|Baseline|Total|Total of all reporting groups
324238|NCT00285779|B2|Baseline|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
324239|NCT00285779|B1|Baseline|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
324240|NCT00285779|P2|Participant Flow|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
324241|NCT00285779|P1|Participant Flow|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
324242|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
324243|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
324244|NCT00285779|E2|Reported Event|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
324245|NCT00285779|E1|Reported Event|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
324250|NCT00285818|P1|Participant Flow|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT
Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
324251|NCT00285818|O2|Outcome|Placebo|Patients receive a placebo pill one day before and for 5 additional days after starting ECT
324252|NCT00285818|O1|Outcome|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT
Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
324253|NCT00285818|E2|Reported Event|Placebo|Patients receive a placebo pill one day before and for 5 additional days after starting ECT
324254|NCT00285818|E1|Reported Event|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT
Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
324255|NCT00285857|B1|Baseline|Lovastatin|Lovastatin: 80 mg; 40 mg orally twice per day
324256|NCT00285857|P1|Participant Flow|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
324257|NCT00285857|O1|Outcome|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
324258|NCT00285857|O1|Outcome|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
324259|NCT00285857|O1|Outcome|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
324260|NCT00285857|O5|Outcome|Baseline Biopsy Acellular|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) generated a sample that was acellular
324327|NCT00286429|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324261|NCT00285857|O4|Outcome|Baseline Carcinoma in Situ or Invasive Cancer (CIS/IC)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of carcinoma in situ or invasive cancer
324262|NCT00285857|O3|Outcome|Baseline Proliferative Breast Disease With Atypia (PBD+A)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease with atypia
324263|NCT00285857|O2|Outcome|Baseline Proliferative Breast Disease Without Atypia (PBD-A)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease without atypia
324264|NCT00285857|O1|Outcome|Baseline Non-proliferative Breast Disease (NPBD)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of non-proliferative breast disease
324265|NCT00285857|E1|Reported Event|Lovastatin|Lovastatin: 80 mg; 40 mg orally twice per day
324266|NCT00286078|B3|Baseline|Total|Total of all reporting groups
324267|NCT00286078|B2|Baseline|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
Precision: Implantable neurostimulator"
324268|NCT00286078|B1|Baseline|Treatment|"Stimulation on
Precision: Implantable neurostimulator"
324269|NCT00286078|P2|Participant Flow|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
Precision: Implantable neurostimulator"
324270|NCT00286078|P1|Participant Flow|Treatment|"Stimulation on
Precision: Implantable neurostimulator"
324271|NCT00286078|O2|Outcome|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
Precision: Implantable neurostimulator"
324272|NCT00286078|O1|Outcome|Treatment|"Stimulation on
Precision: Implantable neurostimulator"
324273|NCT00286078|O2|Outcome|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
Precision: Implantable neurostimulator"
324274|NCT00286078|O1|Outcome|Treatment|"Stimulation on
Precision: Implantable neurostimulator"
324275|NCT00286078|E2|Reported Event|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
Precision: Implantable neurostimulator"
324276|NCT00286078|E1|Reported Event|Treatment|"Stimulation on
Precision: Implantable neurostimulator"
324277|NCT00286091|B3|Baseline|Total|Total of all reporting groups
324278|NCT00286091|B2|Baseline|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
324279|NCT00286091|B1|Baseline|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
324280|NCT00286091|P2|Participant Flow|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
324281|NCT00286091|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
324282|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
324283|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
324284|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
324285|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
324941|NCT00286494|B4|Baseline|Total|Total of all reporting groups
324286|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
324287|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
324288|NCT00286091|E4|Reported Event|OLE: Denosumab/ Denosumab 120 mg Q4W|Participants who received denosumab in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
324289|NCT00286091|E3|Reported Event|OLE: Placebo/ Denosumab 120 mg Q4W|Participants who received placebo in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension (OLE) phase.
324290|NCT00286091|E2|Reported Event|DB: Denosumab 120 mg Q4W|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase.
324291|NCT00286091|E1|Reported Event|DB: Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind (DB) treatment phase.
324292|NCT00286156|B4|Baseline|Total|Total of all reporting groups
324293|NCT00286156|B3|Baseline|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
324328|NCT00286429|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324294|NCT00286156|B2|Baseline|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml
Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
324295|NCT00286156|B1|Baseline|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml
Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
324296|NCT00286156|P3|Participant Flow|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
324297|NCT00286156|P2|Participant Flow|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml
Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
324298|NCT00286156|P1|Participant Flow|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml
Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
324299|NCT00286156|O3|Outcome|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
324300|NCT00286156|O2|Outcome|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml
Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
324301|NCT00286156|O1|Outcome|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml
Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
324302|NCT00286156|O3|Outcome|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
324303|NCT00286156|O2|Outcome|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml
Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
324304|NCT00286156|O1|Outcome|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml
Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
324305|NCT00286156|E3|Reported Event|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
324306|NCT00286156|E2|Reported Event|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml
Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
324307|NCT00286156|E1|Reported Event|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml
Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
324308|NCT00286182|B3|Baseline|Total|Total of all reporting groups
324309|NCT00286182|B2|Baseline|Placebo|"Placebo consists of saline injections.
Placebo: Placebo"
324310|NCT00286182|B1|Baseline|Erythropoietin Alpha|Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
324311|NCT00286182|P2|Participant Flow|Placebo|"Placebo consists of saline injections.
Placebo: Placebo"
324312|NCT00286182|P1|Participant Flow|Erythropoietin Alpha|"Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
Erythropoietin alpha: Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in"
324313|NCT00286182|O2|Outcome|Placebo|"Placebo consists of saline injections.
Placebo: Placebo"
324362|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324363|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324364|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
325635|NCT00279591|O1|Outcome|Intervention Group|
324314|NCT00286182|O1|Outcome|Erythropoietin Alpha|"Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
Erythropoietin alpha: Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in"
324315|NCT00286182|E2|Reported Event|Placebo|"Placebo consists of saline injections.
Placebo: Placebo"
324316|NCT00286182|E1|Reported Event|Erythropoietin Alpha|Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
324317|NCT00286325|B1|Baseline|Treated|Open label study subjects all treated with rituximab
324318|NCT00286325|P1|Participant Flow|Treated|Open label study subjects all treated with rituximab
324319|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
324320|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
324321|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
324322|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
324323|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
324324|NCT00286325|E1|Reported Event|Treated|Open label study subjects all treated with rituximab
324325|NCT00286429|B4|Baseline|Total|Total of all reporting groups
328611|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
324329|NCT00286429|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324330|NCT00286429|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324331|NCT00286429|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324332|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324333|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324334|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324335|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324336|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324337|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324338|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324339|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324340|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324341|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324342|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324343|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324344|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324345|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324346|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324347|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324348|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324349|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324350|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324351|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324352|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324353|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324354|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324355|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324356|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324357|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324358|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324359|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324360|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324361|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
327769|NCT00293813|O1|Outcome|Alendronate 70 mg QW|Alendronate 70 mg QW
324369|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324370|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324371|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324372|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324373|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324374|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324375|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324376|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324377|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324378|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324379|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324380|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324381|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324382|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324383|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324384|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324385|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324386|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324387|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324388|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324389|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324390|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324391|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324392|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324393|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324394|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324395|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324396|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324397|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324398|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324399|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324400|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324401|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324402|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324403|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324404|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324405|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324406|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324407|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324408|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324409|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324410|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324411|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324412|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324413|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324414|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324415|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324416|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324417|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324418|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324419|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324420|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324421|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324422|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324423|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324424|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324425|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324426|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324427|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324428|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324429|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324430|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324431|NCT00286429|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324432|NCT00286429|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
324433|NCT00286429|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
324434|NCT00286442|B4|Baseline|Total|Total of all reporting groups
324435|NCT00286442|B3|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324436|NCT00286442|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324437|NCT00286442|B1|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324438|NCT00286442|P3|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324439|NCT00286442|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324440|NCT00286442|P1|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324441|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324442|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324443|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324444|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324445|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324446|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324447|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324448|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324449|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324450|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324451|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324452|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324453|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324454|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324455|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324456|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324457|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324458|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324459|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324460|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324461|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324462|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324463|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324464|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324465|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324466|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324467|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324468|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324469|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324470|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
327770|NCT00293813|E3|Reported Event|Denosumab 60 mg Q6M|
324471|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324472|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324473|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324474|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324475|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324476|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324477|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324478|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324479|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324480|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324481|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
328612|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
324482|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324483|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324484|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324485|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324486|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324487|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324488|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324489|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324490|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324491|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324492|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324493|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324494|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324495|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324496|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324497|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324498|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324499|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324500|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324501|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324502|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324503|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324504|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324505|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324506|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324507|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324508|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324509|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324510|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324511|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324512|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324513|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324514|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324515|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324516|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324517|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324518|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324519|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324520|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
325293|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
324521|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324522|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324523|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324524|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324525|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324526|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324527|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324528|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324529|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324530|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324531|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324532|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324533|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324534|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324535|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324536|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324537|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324538|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324539|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324540|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324541|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324542|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324543|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324544|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324545|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324546|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324547|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324548|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324549|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324550|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324551|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324552|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324553|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324554|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324555|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324556|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324557|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324558|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324559|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324560|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324561|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324562|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324563|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324564|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324565|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324566|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324567|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324568|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324569|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324570|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324571|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324572|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324573|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324574|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324575|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324576|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324577|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324578|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324579|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324580|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324581|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324582|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324583|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324584|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324585|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324586|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324587|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324588|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324589|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324590|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324591|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324592|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324593|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324594|NCT00286442|E3|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
324595|NCT00286442|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324596|NCT00286442|E1|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
324597|NCT00286455|B4|Baseline|Total|Total of all reporting groups
324598|NCT00286455|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324599|NCT00286455|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324600|NCT00286455|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324601|NCT00286455|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324602|NCT00286455|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324603|NCT00286455|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324604|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324605|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324606|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324607|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324608|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324609|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324610|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324611|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324612|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324613|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324614|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324615|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324616|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324617|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324618|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324619|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324620|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324621|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324622|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324623|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324624|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324625|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324626|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324627|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324628|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324629|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324630|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324631|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324632|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324633|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324634|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324635|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324636|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324637|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324638|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324639|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324640|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324641|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324642|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324643|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324644|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324645|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324646|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324647|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324648|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324649|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324650|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324651|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324652|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324653|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324654|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324655|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324656|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324657|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324658|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324659|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324660|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324661|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324662|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324663|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324664|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324665|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324666|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324667|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324668|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324669|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324670|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324671|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324672|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324673|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324674|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324675|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324676|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324677|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324678|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324679|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324680|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324681|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324682|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324683|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324684|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324685|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324686|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324687|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324688|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324689|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324690|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324691|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324692|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324693|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324694|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324695|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324696|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324697|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324698|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324699|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324700|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324701|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324702|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324703|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324704|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324705|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324706|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324707|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324708|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324709|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324710|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324711|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324712|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324713|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324714|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324715|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324716|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324717|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324718|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324719|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324720|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324721|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324722|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324723|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324724|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324725|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324726|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324727|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324728|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324729|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324730|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324731|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324732|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324733|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324734|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324735|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324736|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324737|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324738|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324739|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324740|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324741|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324742|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324743|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324744|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324745|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324746|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324747|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324748|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324749|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324750|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324751|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324752|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324753|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324754|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324755|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324756|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324757|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324758|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324759|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324760|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324761|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324762|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324763|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324764|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324765|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324766|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324767|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324768|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324769|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324770|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324771|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324772|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324773|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324774|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324775|NCT00286455|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
324776|NCT00286455|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
324777|NCT00286455|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
324778|NCT00286468|B4|Baseline|Total|Total of all reporting groups
324779|NCT00286468|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324780|NCT00286468|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324781|NCT00286468|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324782|NCT00286468|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324783|NCT00286468|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324784|NCT00286468|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324785|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324786|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324787|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324788|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324789|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324790|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324791|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324792|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324793|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324794|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324795|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324796|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324797|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324798|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324799|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324800|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
328613|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
324801|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324802|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324803|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324804|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324805|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324806|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324807|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324808|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324809|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324810|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324811|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324812|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324813|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324814|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324815|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324816|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324817|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324818|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324819|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324820|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324821|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324822|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324823|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324824|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324825|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324826|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324827|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324828|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324829|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324830|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324831|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324832|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324833|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324834|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324835|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324836|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324837|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324838|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
325636|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
324839|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324840|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324841|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324842|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324843|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324844|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324845|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324846|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324847|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324848|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324849|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324850|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324851|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324852|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324853|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324854|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324855|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324856|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324857|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324858|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324859|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324860|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324861|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324862|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324863|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324864|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324865|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324866|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324867|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324868|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324869|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324870|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324871|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324872|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324873|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324874|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324875|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324876|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324877|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324878|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324879|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324880|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324881|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324882|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324883|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324884|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324885|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324886|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324887|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324888|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324889|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324890|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324891|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324892|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324893|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324894|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324895|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324896|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324897|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324898|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324899|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324900|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324901|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324902|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324903|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324904|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324905|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324906|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324907|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324908|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324909|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324910|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324911|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324912|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324913|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324914|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324915|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324916|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324917|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324918|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324919|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324920|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324921|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324922|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324923|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324924|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324925|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324926|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324927|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324928|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324929|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324930|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324931|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324932|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324933|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324934|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324935|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324936|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324937|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324938|NCT00286468|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324939|NCT00286468|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
324940|NCT00286468|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
324942|NCT00286494|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324943|NCT00286494|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324944|NCT00286494|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324945|NCT00286494|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324946|NCT00286494|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324947|NCT00286494|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324948|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324949|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324950|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325155|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
324951|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324952|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324953|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324954|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324955|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324956|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324957|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324958|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324959|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324960|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324961|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324962|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324963|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324964|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324965|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324966|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324967|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324968|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324969|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324970|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324971|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324972|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324973|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324974|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324975|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324976|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324977|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324978|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324979|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325294|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
324980|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324981|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324982|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324983|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324984|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324985|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324986|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324987|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324988|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324989|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
328614|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
324990|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324991|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324992|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324993|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324994|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324995|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324996|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324997|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324998|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
324999|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325000|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325001|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325002|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325003|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325004|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325005|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325006|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325007|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325008|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325009|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325010|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325011|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325012|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325013|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325014|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325015|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325016|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325017|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325018|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325019|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325020|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325021|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325022|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325023|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325024|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325025|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325026|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325027|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325028|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
328615|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
325029|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325030|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325031|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325032|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325033|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325034|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325035|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325036|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325037|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325038|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325039|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325040|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325041|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325042|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325043|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325044|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325045|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325046|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325047|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325048|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325049|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325050|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325051|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325052|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325053|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325054|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325055|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325056|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325057|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325058|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325059|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325060|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325061|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325062|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325063|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325064|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325065|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325066|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325067|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
328616|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
325068|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325069|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325070|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325071|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325072|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325073|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325074|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325075|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325076|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325077|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325078|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325079|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325080|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325081|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325082|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325083|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325084|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325085|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325086|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325087|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325088|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325089|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325090|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325091|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325092|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325093|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325094|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325095|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325096|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325097|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325098|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325099|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325100|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325101|NCT00286494|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325102|NCT00286494|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325103|NCT00286494|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
325104|NCT00286728|B3|Baseline|Total|Total of all reporting groups
325105|NCT00286728|B2|Baseline|Arm 2 Usual Care|Usual care
325106|NCT00286728|B1|Baseline|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups
Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
325107|NCT00286728|P2|Participant Flow|Arm 2 Usual Care|Usual care
325251|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325108|NCT00286728|P1|Participant Flow|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups
Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
325109|NCT00286728|O2|Outcome|Arm 2 Usual Care|Usual care
325110|NCT00286728|O1|Outcome|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups
Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
325111|NCT00286728|E2|Reported Event|Arm 2 Usual Care|Usual care
325112|NCT00286728|E1|Reported Event|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups
Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
325113|NCT00286741|B3|Baseline|Total|Total of all reporting groups
325114|NCT00286741|B2|Baseline|Arm 2|control
325115|NCT00286741|B1|Baseline|Arm 1|"Medical group visits
Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
325116|NCT00286741|P2|Participant Flow|Control|control
325117|NCT00286741|P1|Participant Flow|Medical Group Visits|"Medical group visits
Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
325118|NCT00286741|O2|Outcome|Treatment as Usual Control|control
325119|NCT00286741|O1|Outcome|Medical Group Visits|"Medical group visits
Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
325120|NCT00286741|O2|Outcome|Control|Treatment as Usual Control
325121|NCT00286741|O1|Outcome|Medical Group Visits|Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
325122|NCT00286741|E2|Reported Event|Control|Treatment as Usual Control
325123|NCT00286741|E1|Reported Event|Medical Group Visits|Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
325124|NCT00286754|B4|Baseline|Total|Total of all reporting groups
325125|NCT00286754|B3|Baseline|Usual Care (UC)|treatment as usual for hypertension
325126|NCT00286754|B2|Baseline|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
325127|NCT00286754|B1|Baseline|Stage-Matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
325128|NCT00286754|P3|Participant Flow|Usual Care (UC)|treatment as usual with no additional counseling
325129|NCT00286754|P2|Participant Flow|Health Education Intervention (HEI)|6 monthly phone calls of non-tailored counseling for diet, medication and exercise
325130|NCT00286754|P1|Participant Flow|Stage-matched Intervention (SM)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
325131|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
325132|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
325133|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
325134|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
325135|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
325136|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
325137|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual
325138|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
325139|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
325140|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
325141|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 months of non-tailored counseling for diet, medication and exercise
327771|NCT00293813|E2|Reported Event|Alendronate 70 mg QW|
325142|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
325143|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
325144|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
325145|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
325146|NCT00286754|O3|Outcome|Usual Care (UC)|Treatment as usual for hypertension with no counseling
325147|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of non-tailored education about diet, medication and exercise recommendations
325148|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly calls targeting diet, medication and exercise adherence tailored using the Transtheoretical Model
325149|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
325150|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly phone calls of nontailored counseling for diet, medication and exercise
325151|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
325152|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
325153|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
325154|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
328617|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
325156|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
325157|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
325158|NCT00286754|E3|Reported Event|Usual Care (UC)|treatment as usual for hypertension
325159|NCT00286754|E2|Reported Event|Health Education Intervention (HEI)|6 monthly phone calls of nontailored counseling for diet, medication and exercise
325160|NCT00286754|E1|Reported Event|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
325161|NCT00287053|B3|Baseline|Total|Total of all reporting groups
325162|NCT00287053|B2|Baseline|2. Active Medication|Active medication
325163|NCT00287053|B1|Baseline|1. Inactive Placebo Pill|Inactive placebo pill
325164|NCT00287053|P2|Participant Flow|2. Active Medication|Active medication
325165|NCT00287053|P1|Participant Flow|1. Inactive Placebo Pill|Inactive placebo pill
325166|NCT00287053|O2|Outcome|2. Active Medication|Active medication
325167|NCT00287053|O1|Outcome|1. Inactive Placebo Pill|Inactive placebo pill
325168|NCT00287053|E2|Reported Event|2. Active Medication|Active medication
325169|NCT00287053|E1|Reported Event|1. Inactive Placebo Pill|Inactive placebo pill
325170|NCT00287079|B3|Baseline|Total|Total of all reporting groups
325171|NCT00287079|B2|Baseline|No Treatment|Participants in this group did not receive any treatment.
325172|NCT00287079|B1|Baseline|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
325173|NCT00287079|P2|Participant Flow|No Treatment|Participants in this group did not receive any treatment.
325174|NCT00287079|P1|Participant Flow|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
325175|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
325176|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
325177|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
325178|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
325179|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
325180|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
325181|NCT00287079|E2|Reported Event|No Treatment|Participants in this group did not receive any treatment.
325182|NCT00287079|E1|Reported Event|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
325183|NCT00287222|B1|Baseline|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
325184|NCT00287222|P1|Participant Flow|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
325185|NCT00287222|O1|Outcome|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
325186|NCT00287222|E1|Reported Event|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
325187|NCT00287339|B3|Baseline|Total|Total of all reporting groups
325188|NCT00287339|B2|Baseline|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
325189|NCT00287339|B1|Baseline|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
325190|NCT00287339|P2|Participant Flow|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
325295|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325191|NCT00287339|P1|Participant Flow|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
325192|NCT00287339|O2|Outcome|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
325193|NCT00287339|O1|Outcome|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
325194|NCT00287339|E2|Reported Event|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
325195|NCT00287339|E1|Reported Event|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
325252|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325196|NCT00287365|B1|Baseline|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects
ozone: 2 hour exposure to 0.4 ppm ozone"
325197|NCT00287365|P1|Participant Flow|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects
ozone: 2 hour exposure to 0.4 ppm ozone"
325198|NCT00287365|O2|Outcome|GSTM1 Sufficient|GSTM1 sufficient mild asthmatics
325199|NCT00287365|O1|Outcome|GSTM1 Null|GSTM1 null mild asthmatics
325200|NCT00287365|O2|Outcome|GSTM Sufficient|GSTM1 sufficient mild asthmatics
325201|NCT00287365|O1|Outcome|GSTM1 Null|GSTM1 null mild asthmatics
325202|NCT00287365|E1|Reported Event|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects
ozone: 2 hour exposure to 0.4 ppm ozone"
325203|NCT00287586|B3|Baseline|Total|Total of all reporting groups
325204|NCT00287586|B2|Baseline|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325205|NCT00287586|B1|Baseline|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325206|NCT00287586|P2|Participant Flow|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325207|NCT00287586|P1|Participant Flow|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325208|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325209|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325210|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325211|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325212|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325213|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325214|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325215|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325216|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325296|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325217|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325218|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325219|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325220|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325221|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325222|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325253|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
325254|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325255|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325223|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325224|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325225|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325226|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325227|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325228|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325229|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325230|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325231|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325232|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325233|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325234|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325235|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325236|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325237|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325238|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325297|NCT00287729|E2|Reported Event|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325239|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325240|NCT00287586|E2|Reported Event|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
325241|NCT00287586|E1|Reported Event|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
325242|NCT00287716|B4|Baseline|Total|Total of all reporting groups
325243|NCT00287716|B3|Baseline|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325244|NCT00287716|B2|Baseline|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
325245|NCT00287716|B1|Baseline|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325246|NCT00287716|P3|Participant Flow|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325247|NCT00287716|P2|Participant Flow|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
325248|NCT00287716|P1|Participant Flow|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325249|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325250|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
328618|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
325256|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
325257|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325258|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325259|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
325260|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325261|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325262|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
325263|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325264|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325265|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
325266|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325267|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325268|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
325269|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325270|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325271|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
325272|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325273|NCT00287716|E3|Reported Event|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325274|NCT00287716|E2|Reported Event|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
325275|NCT00287716|E1|Reported Event|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325276|NCT00287729|B3|Baseline|Total|Total of all reporting groups
325277|NCT00287729|B2|Baseline|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325278|NCT00287729|B1|Baseline|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325279|NCT00287729|P2|Participant Flow|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325280|NCT00287729|P1|Participant Flow|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325281|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325282|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325283|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325284|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325285|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325286|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325287|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325288|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325289|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325290|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325291|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
325292|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325298|NCT00287729|E1|Reported Event|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
325299|NCT00287872|B1|Baseline|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide"
325300|NCT00287872|P1|Participant Flow|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide"
325301|NCT00287872|O1|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide"
325302|NCT00287872|O1|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide"
325303|NCT00287872|E1|Reported Event|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
bortezomib
thalidomide"
325304|NCT00288054|B1|Baseline|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
325305|NCT00288054|P1|Participant Flow|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
325306|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
325307|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
325308|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
325309|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
325310|NCT00288054|O1|Outcome|Cetuximab + Chest Radiation Therapy|
325311|NCT00288054|E1|Reported Event|Cetuximab + Chest Radiation Therapy|
325312|NCT00288067|B1|Baseline|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
pharmacological study : Correlative studies
rituximab : Given IV
fenretinide : Given PO"
325313|NCT00288067|P1|Participant Flow|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
pharmacological study : Correlative studies
rituximab : Given IV
fenretinide : Given PO"
325314|NCT00288067|O2|Outcome|Fenretinide and Rituximab (Rituximab Pre Treated)|PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
325315|NCT00288067|O1|Outcome|Fenretinide and Rituximab (Rituximab Naive)|PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
325316|NCT00288067|O1|Outcome|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
pharmacological study : Correlative studies
rituximab : Given IV
fenretinide : Given PO"
325317|NCT00288067|E1|Reported Event|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
pharmacological study : Correlative studies
rituximab : Given IV
fenretinide : Given PO"
325318|NCT00288080|B3|Baseline|Total|Total of all reporting groups
325319|NCT00288080|B2|Baseline|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
325320|NCT00288080|B1|Baseline|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
325321|NCT00288080|P2|Participant Flow|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
325322|NCT00288080|P1|Participant Flow|Androgen Suppression + Radiation Therapy (RT)|Androgen suppression (AS; luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
325323|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
325324|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
325419|NCT00278954|P1|Participant Flow|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
325420|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
325325|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
325326|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
325327|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
325328|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
325329|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
325362|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
325330|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
325331|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
325332|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
325333|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
325334|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
325335|NCT00288080|E2|Reported Event|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
325336|NCT00288080|E1|Reported Event|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
325337|NCT00278863|B3|Baseline|Total|Total of all reporting groups
325338|NCT00278863|B2|Baseline|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
325339|NCT00278863|B1|Baseline|S-1 for 2 Weeks on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
325340|NCT00278863|P2|Participant Flow|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
325341|NCT00278863|P1|Participant Flow|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
325342|NCT00278863|O2|Outcome|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
325343|NCT00278863|O1|Outcome|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
325344|NCT00278863|O2|Outcome|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
325345|NCT00278863|O1|Outcome|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
325346|NCT00278863|E2|Reported Event|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
325637|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
325347|NCT00278863|E1|Reported Event|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
325348|NCT00278876|B1|Baseline|Imatinib Mesylate|patients receiving adjuvant imatinib mesylate
325349|NCT00278876|P1|Participant Flow|Imatinib Mesylate|imatinib mesylate 400 mg daily for 2 years
325350|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate
Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
325351|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate
Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
325352|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate
Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
325353|NCT00278876|E1|Reported Event|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate
Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
325354|NCT00278889|B4|Baseline|Total|Total of all reporting groups
325355|NCT00278889|B3|Baseline|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
325356|NCT00278889|B2|Baseline|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
325357|NCT00278889|B1|Baseline|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
325358|NCT00278889|P3|Participant Flow|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
325359|NCT00278889|P2|Participant Flow|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
325360|NCT00278889|P1|Participant Flow|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
325361|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
325363|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
325364|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
325365|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
325366|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
325367|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
325368|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
325369|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
325370|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
325371|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
325372|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
325373|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
325374|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
325375|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
325376|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
325377|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
325378|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
325379|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
325380|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
325381|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
325382|NCT00278889|E3|Reported Event|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
325383|NCT00278889|E2|Reported Event|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
325384|NCT00278889|E1|Reported Event|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
325385|NCT00278915|B1|Baseline|Fulvestrant|Fulvestrant (4 mg / kg)
325386|NCT00278915|P1|Participant Flow|Fulvestrant|Fulvestrant (4 mg / kg)
325387|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325388|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325389|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325390|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325391|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325392|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325393|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325394|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325395|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325396|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325397|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325398|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325399|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325400|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325401|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325402|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325403|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325404|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325405|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325406|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325407|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325408|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325409|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325410|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325411|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325412|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325413|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325414|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325415|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325416|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
325417|NCT00278915|E1|Reported Event|Fulvestrant|Fulvestrant (4 mg / kg)
325418|NCT00278954|B1|Baseline|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
325421|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
325422|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
325423|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
325424|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
325425|NCT00278954|E1|Reported Event|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
325426|NCT00278993|B1|Baseline|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
325427|NCT00278993|P1|Participant Flow|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
325428|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
325429|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
325430|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
325431|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
325432|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
325433|NCT00278993|E1|Reported Event|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
325434|NCT00279201|B3|Baseline|Total|Total of all reporting groups
325435|NCT00279201|B2|Baseline|Lispro LM|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325436|NCT00279201|B1|Baseline|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325437|NCT00279201|P6|Participant Flow|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325438|NCT00279201|P5|Participant Flow|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325439|NCT00279201|P4|Participant Flow|Lispro Low Mix Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
325440|NCT00279201|P3|Participant Flow|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325441|NCT00279201|P2|Participant Flow|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325442|NCT00279201|P1|Participant Flow|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325443|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325444|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325445|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
325446|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325447|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325448|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325449|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325450|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325451|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325517|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325452|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325453|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
325454|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325455|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325456|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325457|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325528|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325458|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325459|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325460|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325461|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325462|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325463|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325464|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325465|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325466|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325467|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325468|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325469|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325470|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325471|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325472|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325573|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
327772|NCT00293813|E1|Reported Event|Placebo|
325473|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325474|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325475|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325476|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325477|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
325478|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325479|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325768|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
325480|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325481|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
325482|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325483|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
325484|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
325485|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
325486|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
325487|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
325488|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
325489|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
325490|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
325491|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
325492|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
325493|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
325494|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
325495|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
325496|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
325497|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
325498|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
325499|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
325500|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
325501|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
325502|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
325503|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
325504|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
325505|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
325506|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
325507|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
325508|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
325509|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
325510|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
325511|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325512|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325513|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325514|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325515|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325516|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325518|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325519|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325520|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325521|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325522|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325523|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325524|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325525|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325526|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325527|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325592|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325529|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325530|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325531|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
325532|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325533|NCT00279201|O2|Outcome|Did Not Meet Goal|
325534|NCT00279201|O1|Outcome|Met Goal|
325535|NCT00279201|O2|Outcome|Did Not Meet Goal|
325536|NCT00279201|O1|Outcome|Met Goal|
325537|NCT00279201|O2|Outcome|Did Not Meet Goal|
325538|NCT00279201|O1|Outcome|Met Goal|
325539|NCT00279201|O2|Outcome|Did Not Meet Goal|
325540|NCT00279201|O1|Outcome|Met Goal|
325541|NCT00279201|O2|Outcome|Did Not Meet Goal|
325542|NCT00279201|O1|Outcome|Met Goal|
325543|NCT00279201|O2|Outcome|Did Not Meet Goal|
325544|NCT00279201|O1|Outcome|Met Goal|
325545|NCT00279201|O2|Outcome|Did Not Meet Goal|
325546|NCT00279201|O1|Outcome|Met Goal|
325547|NCT00279201|O2|Outcome|Did Not Meet Goal|
325548|NCT00279201|O1|Outcome|Met Goal|
325549|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
325550|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
325551|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
325552|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
325553|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
325554|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
325555|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
325556|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
325557|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
325558|NCT00279201|O1|Outcome|Insulin Gargine|Insulin glargine for 24 weeks.
325559|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
325560|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
325561|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
325562|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
325563|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
325564|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
325565|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
325566|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
325567|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
325568|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
325569|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325570|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
325571|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
325572|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
325574|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
325575|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
325576|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
325577|NCT00279201|E8|Reported Event|Lispro LM Maintenance|
325578|NCT00279201|E7|Reported Event|Insulin Glargine Maintenance|
325579|NCT00279201|E6|Reported Event|Basal Bolus Prior Glargine Addendum|
325580|NCT00279201|E5|Reported Event|Basal Bolus Prior Lispro LM Addendum|
325581|NCT00279201|E4|Reported Event|Lispro LM Prior Glargine Addendum|
325582|NCT00279201|E3|Reported Event|Lispro Mid Mix Prior Lispro LM Addendum|
325583|NCT00279201|E2|Reported Event|Lispro LM Initiation|
325584|NCT00279201|E1|Reported Event|Insulin Glargine Initiation|
325585|NCT00279214|B3|Baseline|Total|Total of all reporting groups
325586|NCT00279214|B2|Baseline|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325587|NCT00279214|B1|Baseline|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325588|NCT00279214|P2|Participant Flow|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325589|NCT00279214|P1|Participant Flow|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325590|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325591|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325593|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325594|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325595|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325596|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325597|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325598|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325599|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325600|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325601|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325602|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325603|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325604|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325605|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325606|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325607|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325608|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325609|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325610|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325611|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325612|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325613|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325614|NCT00279214|E2|Reported Event|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
325615|NCT00279214|E1|Reported Event|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
325616|NCT00279305|B3|Baseline|Total|Total of all reporting groups
325617|NCT00279305|B2|Baseline|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
325618|NCT00279305|B1|Baseline|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
325619|NCT00279305|P2|Participant Flow|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
325620|NCT00279305|P1|Participant Flow|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
325621|NCT00279305|O2|Outcome|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
325622|NCT00279305|O1|Outcome|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
325623|NCT00279305|E2|Reported Event|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
325624|NCT00279305|E1|Reported Event|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
325625|NCT00279591|B3|Baseline|Total|Total of all reporting groups
325626|NCT00279591|B2|Baseline|Intervention Group|Near Continuous Blood Pressure Monitoring
325627|NCT00279591|B1|Baseline|Control Group|Oscillometric Blood Pressure Monitoring
325628|NCT00279591|P2|Participant Flow|Intervention Group|Near Continuous Blood Pressure Monitoring
325629|NCT00279591|P1|Participant Flow|Control Group|Oscillometric Blood Pressure Monitoring
325630|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
325638|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
325639|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
325640|NCT00279591|E2|Reported Event|Intervention Group|Near Continuous Blood Pressure Monitoring
325641|NCT00279591|E1|Reported Event|Control Group|Oscillometric Blood Pressure Monitoring
325642|NCT00279708|B3|Baseline|Total|Total of all reporting groups
325643|NCT00279708|B2|Baseline|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
325644|NCT00279708|B1|Baseline|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
325706|NCT00280384|P7|Participant Flow|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325645|NCT00279708|P2|Participant Flow|Control Group (Placebo)|Placebo In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
325646|NCT00279708|P1|Participant Flow|Intervention Group (Atorvastatin)|Atorvastatin Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
325647|NCT00279708|O2|Outcome|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study: Placebo vs. Atorvastatin
325648|NCT00279708|O1|Outcome|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
325649|NCT00279708|E2|Reported Event|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
325650|NCT00279708|E1|Reported Event|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
325651|NCT00279916|B3|Baseline|Total|Total of all reporting groups
325652|NCT00279916|B2|Baseline|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
325653|NCT00279916|B1|Baseline|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
325654|NCT00279916|P2|Participant Flow|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
325655|NCT00279916|P1|Participant Flow|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
325656|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
325657|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
325658|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
325659|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
325660|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
325661|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
325662|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
325663|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
325664|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
325665|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
325666|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
325667|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
325668|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
325669|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
325670|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
325671|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
325672|NCT00279916|E2|Reported Event|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
325673|NCT00279916|E1|Reported Event|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
325674|NCT00280241|B1|Baseline|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
325675|NCT00280241|P1|Participant Flow|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
325676|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
325677|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
325678|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
325894|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325679|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
325680|NCT00280241|E1|Reported Event|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
325681|NCT00280293|B3|Baseline|Total|Total of all reporting groups
325682|NCT00280293|B2|Baseline|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
328619|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
325683|NCT00280293|B1|Baseline|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325684|NCT00280293|P2|Participant Flow|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325685|NCT00280293|P1|Participant Flow|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325686|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325687|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325688|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325689|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325690|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325691|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325692|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325693|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325694|NCT00280293|E2|Reported Event|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325695|NCT00280293|E1|Reported Event|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
325696|NCT00280384|B9|Baseline|Total|Total of all reporting groups
325697|NCT00280384|B8|Baseline|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325698|NCT00280384|B7|Baseline|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325699|NCT00280384|B6|Baseline|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325700|NCT00280384|B5|Baseline|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325701|NCT00280384|B4|Baseline|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325702|NCT00280384|B3|Baseline|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325703|NCT00280384|B2|Baseline|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325704|NCT00280384|B1|Baseline|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325705|NCT00280384|P8|Participant Flow|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325766|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
325707|NCT00280384|P6|Participant Flow|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325708|NCT00280384|P5|Participant Flow|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325709|NCT00280384|P4|Participant Flow|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325710|NCT00280384|P3|Participant Flow|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325711|NCT00280384|P2|Participant Flow|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325712|NCT00280384|P1|Participant Flow|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325713|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325714|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325715|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325716|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325717|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325718|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325719|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325720|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325721|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325722|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325723|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325724|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325725|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325726|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325727|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325728|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
327773|NCT00294398|B3|Baseline|Total|Total of all reporting groups
325729|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325730|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325731|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325732|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325733|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325734|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325767|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
328620|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
325735|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325736|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325737|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325738|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325739|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325740|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325741|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325742|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325743|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325744|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325745|NCT00280384|E8|Reported Event|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325746|NCT00280384|E7|Reported Event|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325747|NCT00280384|E6|Reported Event|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325748|NCT00280384|E5|Reported Event|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
325749|NCT00280384|E4|Reported Event|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325750|NCT00280384|E3|Reported Event|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325751|NCT00280384|E2|Reported Event|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325752|NCT00280384|E1|Reported Event|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
325753|NCT00280397|B1|Baseline|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
325754|NCT00280397|P1|Participant Flow|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
325755|NCT00280397|O2|Outcome|E7080 - 20 mg Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
325756|NCT00280397|O1|Outcome|E7080 - 16 mg Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
325757|NCT00280397|O1|Outcome|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
325758|NCT00280397|O1|Outcome|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
325759|NCT00280397|E1|Reported Event|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
325760|NCT00280566|B3|Baseline|Total|Total of all reporting groups
325761|NCT00280566|B2|Baseline|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
325762|NCT00280566|B1|Baseline|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
325763|NCT00280566|P3|Participant Flow|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
325764|NCT00280566|P2|Participant Flow|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
325765|NCT00280566|P1|Participant Flow|Period 1 Open Label Ziprasidone|40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.
325769|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
325770|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
325771|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
325772|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
325773|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
325774|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
325775|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
325776|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
325777|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
325778|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
325779|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
325780|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
325781|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
325782|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
325783|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
325784|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
325785|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
325786|NCT00280566|E3|Reported Event|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
325787|NCT00280566|E2|Reported Event|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
325788|NCT00280566|E1|Reported Event|Period 1 Open Label Ziprasidone|40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.
325789|NCT00280683|B3|Baseline|Total|Total of all reporting groups
325790|NCT00280683|B2|Baseline|Placebo|Placebo intervention
325791|NCT00280683|B1|Baseline|Arginine|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study.
325792|NCT00280683|P2|Participant Flow|Placebo|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded.
325793|NCT00280683|P1|Participant Flow|Arginine|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded.
325794|NCT00280683|O2|Outcome|Placebo|Matching placebo tablets were disbursed by the Investigational Drug Service.
325795|NCT00280683|O1|Outcome|Arginine|L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study.
325796|NCT00280683|O2|Outcome|Placebo|Matching placebo tablets were made by Jarrow Formulas.
325797|NCT00280683|O1|Outcome|Arginine|The L-arginine 1g tablets were from Jarrow formulas (Los Angeles, CA). The name of these tablets is Arginine 1000.
325798|NCT00280683|E2|Reported Event|Placebo|Matching placebo tablets were purchased from Jarrow Formulas.
325799|NCT00280683|E1|Reported Event|Arginine|L-arginine 1 g tablets were made by Jarrow Formulas.
325800|NCT00280735|B1|Baseline|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
325895|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325801|NCT00280735|P1|Participant Flow|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
325802|NCT00280735|O1|Outcome|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
325803|NCT00280735|O1|Outcome|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
325804|NCT00280735|O3|Outcome|Grade 3/4 %|Percentage of patients receiving treatment who developed this toxicity
325805|NCT00280735|O2|Outcome|Grade 4 %|Percentage of patients receiving treatment who developed this toxicity
325806|NCT00280735|O1|Outcome|Grade 3 %|Percentage of patients receiving treatment who developed this toxicity
325807|NCT00280735|O1|Outcome|Single Arm Trial|Patients who relapsed
325808|NCT00280735|O1|Outcome|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
325809|NCT00280735|E1|Reported Event|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
325810|NCT00280748|B1|Baseline|Single Arm Study|"Single Arm Study
pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days
radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
325811|NCT00280748|P1|Participant Flow|Single Arm Study|"Single Arm Study
pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days
radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
325812|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study
pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days
radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
325813|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study
pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days
radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
325814|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study
pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days
radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
325815|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study
pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days
radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
325816|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study
pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days
radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
325817|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study
pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days
radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
325818|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study
pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days
radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
325819|NCT00280748|E1|Reported Event|Single Arm Study|"Single Arm Study
pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days
radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
325820|NCT00280826|B1|Baseline|Efalizumab|Treatment of cystoid macular edema due to uveitis
325821|NCT00280826|P1|Participant Flow|Efalizumab|Treatment of cystoid macular edema due to uveitis
325822|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
325823|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
325824|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
325825|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
325826|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
325827|NCT00280826|E1|Reported Event|Efalizumab|Treatment of cystoid macular edema due to uveitis
325828|NCT00280904|B1|Baseline|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
325829|NCT00280904|P1|Participant Flow|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
325830|NCT00280904|O1|Outcome|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo antibiotic impregnated (AI) or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
325831|NCT00280904|O1|Outcome|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo antibiotic impregnated(AI)or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
325832|NCT00280904|E1|Reported Event|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
325833|NCT00280917|B5|Baseline|Total|Total of all reporting groups
325834|NCT00280917|B4|Baseline|Placebo|Matching Placebo q12 hours for 12 weeks
325835|NCT00280917|B3|Baseline|CF101 4mg|CF101 4 mg q12 hours for 12 weeks
325836|NCT00280917|B2|Baseline|CF101 1mg|CF101 1 mg q12 hours for 12 weeks
325837|NCT00280917|B1|Baseline|CF101 0.1mg|CF101 0.1 mg q12 hours for 12 weeks
325838|NCT00280917|P4|Participant Flow|Placebo|Matching placebo q12 hours orally
325839|NCT00280917|P3|Participant Flow|CF101 4mg|CF101 4mg q12 hours orally
325840|NCT00280917|P2|Participant Flow|CF101 1mg|CF101 1mg q12 hours orally
325841|NCT00280917|P1|Participant Flow|CF101 0.1mg|CF101 0.1 mg q12 hours orally
325842|NCT00280917|O4|Outcome|Placebo|Matching placebo q12 hours for 12 weeks
325843|NCT00280917|O3|Outcome|CF101 4 mg|CF101 4 mg q12 hours for 12 weeks
325844|NCT00280917|O2|Outcome|CF101 1 mg|CF101 1 mg q12 hours for 12 weeks
325845|NCT00280917|O1|Outcome|CF101 0.1 mg|CF101 0.1 mg q12 hours for 12 weeks
325846|NCT00280917|E4|Reported Event|Placebo|Matching placebo
325847|NCT00280917|E3|Reported Event|CF101 4mg|CF101 4 mg given orally q12h for 12 weeks
325848|NCT00280917|E2|Reported Event|CF101 1mg|CF101 1 mg given orally q12h for 12 weeks
325849|NCT00280917|E1|Reported Event|CF101 0.1mg|CF101 0.1 mg given orally q12h for 12 weeks
328621|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
325850|NCT00281021|B1|Baseline|Erlotinib and Digoxin|"Erlotinib plus Digoxin
Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
325851|NCT00281021|P1|Participant Flow|Erlotinib and Digoxin|"Erlotinib plus Digoxin
Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
325852|NCT00281021|O1|Outcome|Erlotinib and Digoxin|"Erlotinib plus Digoxin
Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
325853|NCT00281021|E1|Reported Event|Erlotinib and Digoxin|"Erlotinib plus Digoxin
Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
325854|NCT00281099|B3|Baseline|Total|Total of all reporting groups
325855|NCT00281099|B2|Baseline|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325856|NCT00281099|B1|Baseline|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
325857|NCT00281099|P2|Participant Flow|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325858|NCT00281099|P1|Participant Flow|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
325859|NCT00281099|O1|Outcome|All Screened Patients|All Patients Screened for Possible Enrollment
325860|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325861|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325862|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325863|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325864|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325865|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325866|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325867|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325868|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325869|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325870|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325871|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325872|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325873|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325874|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325875|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325876|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325877|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325878|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325879|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325880|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325881|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325882|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325883|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325884|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325885|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325886|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325887|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325888|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325889|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325890|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325891|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325892|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325893|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
325896|NCT00281099|E2|Reported Event|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
325897|NCT00281099|E1|Reported Event|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
325898|NCT00281320|B3|Baseline|Total|Total of all reporting groups
325899|NCT00281320|B2|Baseline|Asenapine 5-10 mg BID|Asenapine 5 mg twice daily (BID) on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
325900|NCT00281320|B1|Baseline|Asenapine 2-10 mg BID|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
325901|NCT00281320|P2|Participant Flow|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
325902|NCT00281320|P1|Participant Flow|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
325903|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asenapine for Day 8.
325904|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asenapine for Day 4.
325905|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asenapine for Day 8.
325906|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asenapine for Day 4.
325907|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameters of asepanine for Day 8.
325908|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameters of asepanine for Day 4.
325909|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
325910|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
325911|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
325912|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
325913|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
325914|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
325915|NCT00281320|O2|Outcome|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
325916|NCT00281320|O1|Outcome|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
325917|NCT00281320|O2|Outcome|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
325918|NCT00281320|O1|Outcome|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
325919|NCT00281320|E2|Reported Event|Asenapine 5-10mg BID|
325920|NCT00281320|E1|Reported Event|Asenapine 2-10mg BID|
325921|NCT00281463|B1|Baseline|Pushrim Activated Power Assist Wheelchair|"Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
325922|NCT00281463|P1|Participant Flow|Pushrim Activated Power Assist Wheelchair|"Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
325923|NCT00281463|O1|Outcome|Pushrim Activated Power Assist Wheelchair|Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
325924|NCT00281463|O1|Outcome|Pushrim Activated Power Assist Wheelchair|Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
325925|NCT00281463|E1|Reported Event|Pushrim Activated Power Assist Wheelchair|"Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
325926|NCT00281528|B4|Baseline|Total|Total of all reporting groups
325927|NCT00281528|B3|Baseline|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325928|NCT00281528|B2|Baseline|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325929|NCT00281528|B1|Baseline|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325930|NCT00281528|P3|Participant Flow|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325931|NCT00281528|P2|Participant Flow|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325932|NCT00281528|P1|Participant Flow|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325933|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325934|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325935|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325936|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325937|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325938|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325939|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325940|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325941|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325942|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325943|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
326254|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
325944|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325945|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325946|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325947|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325948|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325949|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325950|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325951|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325952|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325953|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325954|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325955|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325956|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325957|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325958|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325959|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325960|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325961|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325962|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325963|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325964|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325965|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325966|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325967|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325968|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325969|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325970|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325971|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325972|NCT00281528|E3|Reported Event|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
325973|NCT00281528|E2|Reported Event|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
325974|NCT00281528|E1|Reported Event|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
325975|NCT00281580|B17|Baseline|Total|Total of all reporting groups
325976|NCT00281580|B16|Baseline|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
325977|NCT00281580|B15|Baseline|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
325978|NCT00281580|B14|Baseline|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
325979|NCT00281580|B13|Baseline|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
325980|NCT00281580|B12|Baseline|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
325981|NCT00281580|B11|Baseline|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
328362|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
325982|NCT00281580|B10|Baseline|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
325983|NCT00281580|B9|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
325984|NCT00281580|B8|Baseline|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
325985|NCT00281580|B7|Baseline|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
325986|NCT00281580|B6|Baseline|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
325987|NCT00281580|B5|Baseline|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
325988|NCT00281580|B4|Baseline|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
325989|NCT00281580|B3|Baseline|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
325990|NCT00281580|B2|Baseline|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
325991|NCT00281580|B1|Baseline|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
325992|NCT00281580|P16|Participant Flow|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
325993|NCT00281580|P15|Participant Flow|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
325994|NCT00281580|P14|Participant Flow|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
328622|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
325995|NCT00281580|P13|Participant Flow|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
325996|NCT00281580|P12|Participant Flow|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
325997|NCT00281580|P11|Participant Flow|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
325998|NCT00281580|P10|Participant Flow|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
325999|NCT00281580|P9|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326000|NCT00281580|P8|Participant Flow|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326001|NCT00281580|P7|Participant Flow|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326002|NCT00281580|P6|Participant Flow|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326003|NCT00281580|P5|Participant Flow|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326004|NCT00281580|P4|Participant Flow|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326005|NCT00281580|P3|Participant Flow|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326006|NCT00281580|P2|Participant Flow|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326007|NCT00281580|P1|Participant Flow|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326008|NCT00281580|O4|Outcome|Combination Therapy|Telmisartan 20/40/80mg tablet plus 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning
326009|NCT00281580|O3|Outcome|Amlodipine Monotherapy|encapsulated Amlodipine 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning
326010|NCT00281580|O2|Outcome|Telmisartan Monotherapy|Telmisartan 20/40/80mg tablet, QD in morning
326011|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326012|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326013|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326014|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
326015|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326016|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326017|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326018|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
326019|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326020|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326021|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326022|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
326023|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326024|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326025|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326026|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326027|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326028|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326029|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326030|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
326031|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
327453|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
326032|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326033|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326034|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
326035|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326036|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326037|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326038|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
326039|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326040|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326041|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326042|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326043|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326044|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326045|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326046|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
326047|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326048|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326049|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326050|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326051|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326052|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326053|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326054|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326055|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326056|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326057|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326058|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326059|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326060|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326061|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
326062|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326063|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326064|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326065|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326066|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326067|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326068|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326069|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326070|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326071|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326072|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326073|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326074|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
326075|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326076|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326077|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326078|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326079|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326080|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326081|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
326082|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
326083|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326084|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326085|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326086|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326087|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326088|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326089|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326090|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326091|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326092|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326093|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326094|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326095|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326096|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
328623|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
326097|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
326098|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326099|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326100|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326101|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326102|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326103|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326104|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326105|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326106|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326107|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326108|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326109|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326110|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326111|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326112|NCT00281580|O15|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326113|NCT00281580|O14|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326114|NCT00281580|O13|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326115|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326116|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326117|NCT00281580|O10|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
326118|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326119|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326120|NCT00281580|O7|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326121|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326122|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326123|NCT00281580|O4|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326124|NCT00281580|O3|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326125|NCT00281580|O2|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326126|NCT00281580|O1|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326127|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326128|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326129|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326130|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326131|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326132|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
326133|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326134|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
328363|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
326135|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326136|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326137|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326138|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326139|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326140|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326141|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326142|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326143|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326144|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326145|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326146|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326147|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326148|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
326149|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326150|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326151|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326152|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326153|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326154|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326155|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326156|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326157|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326158|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326159|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10) - Overall|Overall: including all treatment groups involving A10
326160|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5) - Overall|Overall: including all treatment groups involving A5
326161|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5) - Overall|Overall: including all treatment groups involving A2.5
326162|NCT00281580|O1|Outcome|Amlodipine 0 mg (A0) - Overall|Overall: including Pl, T20, T40, and T80 treatment groups
326163|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10) - Overall|Overall: including all treatment groups involving A10
326164|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5) - Overall|Overall: including all treatment groups involving A5
326165|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5) - Overall|Overall: including all treatment groups involving A2.5
326166|NCT00281580|O1|Outcome|Amlodipine 0 mg (A0) - Overall|Overall: including Pl, T20, T40, and T80 treatment groups
326167|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
326168|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326169|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326170|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326171|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
326172|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
326173|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
326174|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
326175|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326176|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326177|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326178|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326179|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326180|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326181|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326182|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326183|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326184|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326185|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326186|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326187|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326188|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326189|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326190|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326191|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326192|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326193|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326194|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326195|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326196|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326197|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326198|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326199|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326200|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326201|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326926|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
326202|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326203|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326204|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326205|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326206|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326207|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326208|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326209|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326210|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326211|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326212|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326213|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326214|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326215|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326216|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326217|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326218|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326219|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326220|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326221|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326222|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326223|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326224|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326225|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326226|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326227|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326228|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
326229|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326230|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326231|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326232|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326233|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326234|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326235|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326236|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326237|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326238|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326239|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326240|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326241|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326242|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326243|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326244|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
326245|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326246|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326247|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326248|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326249|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326250|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326251|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326252|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326253|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326255|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326256|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326257|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326258|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326259|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326260|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
326261|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326262|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326263|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326264|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326265|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326266|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326267|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326268|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326269|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326270|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326271|NCT00281580|O15|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326272|NCT00281580|O14|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326273|NCT00281580|O13|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326274|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326275|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326276|NCT00281580|O10|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
326277|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326278|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326279|NCT00281580|O7|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326280|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326281|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326282|NCT00281580|O4|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326283|NCT00281580|O3|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326284|NCT00281580|O2|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326285|NCT00281580|O1|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326286|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326287|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326288|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326289|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326290|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326291|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
326292|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326293|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326294|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326295|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326296|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326297|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326298|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326299|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326300|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326301|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326302|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
326303|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326304|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326305|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
326306|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
326307|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
328624|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
326308|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
326309|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
326310|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
326311|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
326312|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
326313|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
326314|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
326315|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
326316|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
326317|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326318|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
326319|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326320|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326321|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326322|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
326323|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
326324|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
326325|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
326326|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
326327|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
326328|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
326329|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
326330|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
326331|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
326332|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
326333|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
326334|NCT00281580|E16|Reported Event|Amlodipine 10 mg (A10)|
326335|NCT00281580|E15|Reported Event|Amlodipine 5 mg (A5)|
326336|NCT00281580|E14|Reported Event|Amlodipine 2.5 mg (A2.5)|
326337|NCT00281580|E13|Reported Event|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|
326338|NCT00281580|E12|Reported Event|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|
326339|NCT00281580|E11|Reported Event|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|
326340|NCT00281580|E10|Reported Event|Telmisartan 80 mg (T80)|
326341|NCT00281580|E9|Reported Event|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|
326342|NCT00281580|E8|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|
326343|NCT00281580|E7|Reported Event|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|
326344|NCT00281580|E6|Reported Event|Telmisartan 40 mg (T40)|
326345|NCT00281580|E5|Reported Event|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|
326346|NCT00281580|E4|Reported Event|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|
326347|NCT00281580|E3|Reported Event|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|
326348|NCT00281580|E2|Reported Event|Telmisartan 20 mg (T20)|
326349|NCT00281580|E1|Reported Event|PLACEBO|
326350|NCT00281632|B1|Baseline|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326351|NCT00281632|P1|Participant Flow|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326352|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326353|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326354|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326355|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326356|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326357|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326358|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326359|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326360|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326361|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326362|NCT00281632|O1|Outcome|Pazopanib 800 mg|: 800 milligrams (mg) pazopanib administered orally once daily
326363|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326364|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326365|NCT00281632|O3|Outcome|Pazopanib 800 mg All|800 milligrams (mg) pazopanib administered orally once daily All participants
326366|NCT00281632|O2|Outcome|Pazopanib 800 mg Non-Responders|800 milligrams (mg) pazopanib administered orally once daily Non-Responders
326367|NCT00281632|O1|Outcome|Pazopanib 800 mg Responders|800 milligrams (mg) pazopanib administered orally once daily Responders
326368|NCT00281632|O3|Outcome|Pazopanib 800 mg All|All participants administered 800 milligrams (mg) pazopanib administered orally once daily
326369|NCT00281632|O2|Outcome|Pazopanib 800 mg Without Measurable Disease|Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
326370|NCT00281632|O1|Outcome|Pazopanib 800 mg With Measurable Disease|Participants with measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily
326371|NCT00281632|O1|Outcome|Overall Study Arm|
326372|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326373|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326374|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326375|NCT00281632|E1|Reported Event|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
326376|NCT00281658|B3|Baseline|Total|Total of all reporting groups
326377|NCT00281658|B2|Baseline|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
326378|NCT00281658|B1|Baseline|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
326379|NCT00281658|P3|Participant Flow|Lapatinib 1500 mg|Lapatinib 1500 mg administered once daily
326380|NCT00281658|P2|Participant Flow|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
326381|NCT00281658|P1|Participant Flow|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
326382|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
326383|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
326384|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
326385|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
326386|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
326387|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
326388|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
326389|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
326390|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
326391|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
326392|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
326393|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
326394|NCT00281658|E3|Reported Event|Lapatinib 1500 mg|Lapatinib 1500 mg administered once daily. This is not a comparative treatment arm.
326395|NCT00281658|E2|Reported Event|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
326396|NCT00281658|E1|Reported Event|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
326397|NCT00281697|B3|Baseline|Total|Total of all reporting groups
326545|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
326398|NCT00281697|B2|Baseline|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
326399|NCT00281697|B1|Baseline|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
326400|NCT00281697|P2|Participant Flow|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
326401|NCT00281697|P1|Participant Flow|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
326402|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
326403|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
326404|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
326868|NCT00282672|O1|Outcome|All LGD Patients|LGD: Sham procedure group crossed over to LGD: Radiofrequency group at 12 month
326405|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
326406|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
326407|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
326408|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
326409|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
326410|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
326411|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
326412|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
326413|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
326414|NCT00281697|E2|Reported Event|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
326415|NCT00281697|E1|Reported Event|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
326416|NCT00281827|B1|Baseline|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
326417|NCT00281827|P1|Participant Flow|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
326418|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
326419|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
326420|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
326421|NCT00281827|O1|Outcome|Intent-To-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
326422|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
326423|NCT00281827|O1|Outcome|Evaluable Patients|Patients receiving 3 complete cycles of treatment (all 3 drugs over 3 - 21 day time periods).
326424|NCT00281827|E1|Reported Event|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
326496|NCT00281957|P1|Participant Flow|Sorafenib + Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
326497|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Sorafenib and Tipifarnib
326498|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Sorafenib and Temsirolimus
326425|NCT00281840|B1|Baseline|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
326426|NCT00281840|P1|Participant Flow|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
326427|NCT00281840|O1|Outcome|Bevacizumab With Docetaxel and Radiation Therapy|"bevacizumab: Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.
docetaxel: docetaxel IV over 1 hour once a week for 8 weeks
conventional surgery: 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection
radiation therapy: radiotherapy once daily, 5 days a week, for 8 weeks"
326449|NCT00281879|O6|Outcome|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
326869|NCT00282672|O4|Outcome|HGD Radiofrequency Ablation|
326428|NCT00281840|O1|Outcome|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
326429|NCT00281840|E1|Reported Event|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
326430|NCT00281879|B9|Baseline|Total|Total of all reporting groups
326431|NCT00281879|B8|Baseline|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
326432|NCT00281879|B7|Baseline|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
326433|NCT00281879|B6|Baseline|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
326434|NCT00281879|B5|Baseline|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
326470|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
328364|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
326435|NCT00281879|B4|Baseline|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
326436|NCT00281879|B3|Baseline|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
326437|NCT00281879|B2|Baseline|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
326438|NCT00281879|B1|Baseline|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
328625|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
326439|NCT00281879|P8|Participant Flow|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
326440|NCT00281879|P7|Participant Flow|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
326441|NCT00281879|P6|Participant Flow|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
326442|NCT00281879|P5|Participant Flow|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
326443|NCT00281879|P4|Participant Flow|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
326444|NCT00281879|P3|Participant Flow|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
326499|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
327454|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
326445|NCT00281879|P2|Participant Flow|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
326446|NCT00281879|P1|Participant Flow|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
326447|NCT00281879|O8|Outcome|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
326448|NCT00281879|O7|Outcome|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
326870|NCT00282672|O3|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|Crossed over to HGD: Radiofrequency
326450|NCT00281879|O5|Outcome|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
326451|NCT00281879|O4|Outcome|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
326452|NCT00281879|O3|Outcome|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
326453|NCT00281879|O2|Outcome|Busulfan and Cyclophosphamide (Cytoxan)|
326454|NCT00281879|O1|Outcome|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|
326455|NCT00281879|E8|Reported Event|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
326456|NCT00281879|E7|Reported Event|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
326471|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
328365|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
326457|NCT00281879|E6|Reported Event|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
326458|NCT00281879|E5|Reported Event|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
326459|NCT00281879|E4|Reported Event|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
326460|NCT00281879|E3|Reported Event|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
326461|NCT00281879|E2|Reported Event|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
326481|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326462|NCT00281879|E1|Reported Event|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
326463|NCT00281918|B3|Baseline|Total|Total of all reporting groups
326464|NCT00281918|B2|Baseline|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326465|NCT00281918|B1|Baseline|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326466|NCT00281918|P2|Participant Flow|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326467|NCT00281918|P1|Participant Flow|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326468|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326469|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326494|NCT00281957|B1|Baseline|Arm I: Sorafenib + Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
326495|NCT00281957|P2|Participant Flow|Sorafenib + Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
326472|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326473|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326474|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326475|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326476|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326477|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326478|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326479|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326480|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326482|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326483|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326484|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326485|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326486|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326487|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326488|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326489|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326490|NCT00281918|E2|Reported Event|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
326491|NCT00281918|E1|Reported Event|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
326492|NCT00281957|B3|Baseline|Total|Total of all reporting groups
326493|NCT00281957|B2|Baseline|Arm II: Sorafenib + Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
327455|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
326500|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
326501|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
326502|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
326503|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
326504|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
326505|NCT00281957|E2|Reported Event|Arm II|Sorafenib and Tipifarnib
326506|NCT00281957|E1|Reported Event|Arm I|Sorafenib and Temsirolimu
326507|NCT00282048|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326508|NCT00282048|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326509|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326510|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326511|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326512|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326513|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326871|NCT00282672|O2|Outcome|LGD:Radiofrequency|
328626|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
326514|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326515|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326516|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326517|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326518|NCT00282048|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
326519|NCT00282087|B1|Baseline|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
326520|NCT00282087|P1|Participant Flow|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|Gemcitabine 900 mg/m2 on days 1 and 8 intravenously over 90 minutes, followed by Docetaxel 75 mg/m2 on day 8 intravenously over 1 hour.
326521|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
326522|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
326523|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
326524|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
326525|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
326526|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
326527|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
326528|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
326529|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|Number of major toxicity events
326530|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
326531|NCT00282087|E1|Reported Event|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
326532|NCT00282113|B4|Baseline|Total|Total of all reporting groups
326533|NCT00282113|B3|Baseline|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
326534|NCT00282113|B2|Baseline|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
326535|NCT00282113|B1|Baseline|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
326536|NCT00282113|P3|Participant Flow|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
326537|NCT00282113|P2|Participant Flow|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
326538|NCT00282113|P1|Participant Flow|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
326539|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
326540|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
326541|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
326542|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
326543|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
326544|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
328366|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
326546|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
326547|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
326548|NCT00282113|E3|Reported Event|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
326549|NCT00282113|E2|Reported Event|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
326550|NCT00282113|E1|Reported Event|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
326551|NCT00282152|B3|Baseline|Total|Total of all reporting groups
326552|NCT00282152|B2|Baseline|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
326553|NCT00282152|B1|Baseline|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
326699|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326554|NCT00282152|P2|Participant Flow|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
326555|NCT00282152|P1|Participant Flow|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
326556|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
326557|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
326558|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
326559|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
326560|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
327456|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
326561|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
326562|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
326563|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
326564|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
328627|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
326565|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
326566|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive B-STN DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
326567|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
326568|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
326569|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
326570|NCT00282152|E2|Reported Event|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive B-STN DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
326571|NCT00282152|E1|Reported Event|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
327457|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
326572|NCT00282243|B1|Baseline|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326573|NCT00282243|P1|Participant Flow|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326574|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326639|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326700|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326575|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326576|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326577|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326578|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326579|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326580|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326581|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326582|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326583|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326640|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326701|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326584|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326585|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326586|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326587|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326588|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326589|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326590|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326591|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326592|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326641|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326702|NCT00282308|E6|Reported Event|Group B - Safety Follow-up Period|Patients received no treatment during the Safety Follow-up Period.
326593|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326594|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326595|NCT00282243|E1|Reported Event|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
326596|NCT00282256|B1|Baseline|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326597|NCT00282256|P1|Participant Flow|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326598|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326626|NCT00282295|B1|Baseline|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
327458|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
326599|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326600|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326601|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326602|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326603|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326642|NCT00282295|O1|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326604|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326605|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326606|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326607|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326608|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326609|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326627|NCT00282295|P3|Participant Flow|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
327054|NCT00291655|O1|Outcome|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
326610|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326611|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326612|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326613|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326614|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326615|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326703|NCT00282308|E5|Reported Event|Group A - Safety Follow-up Period|Patients received no treatment during the Safety Follow-up Period.
326616|NCT00282256|E1|Reported Event|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
326617|NCT00282282|B1|Baseline|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
326618|NCT00282282|P1|Participant Flow|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
326619|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus GVHD Prophylaxis|
326620|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus|
326621|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus|
326622|NCT00282282|E1|Reported Event|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
326623|NCT00282295|B4|Baseline|Total|Total of all reporting groups
326624|NCT00282295|B3|Baseline|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326625|NCT00282295|B2|Baseline|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326902|NCT00291161|B4|Baseline|Caregivers-Usual Care Comparison Group|Caregivers to veterans with diagnosed dementia receiving educational materials and usual care
326628|NCT00282295|P2|Participant Flow|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326629|NCT00282295|P1|Participant Flow|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326630|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326631|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326632|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326633|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326634|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326635|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326636|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326637|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326638|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326643|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326644|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326645|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326646|NCT00282295|O1|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326647|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326648|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326649|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326650|NCT00282295|O1|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326651|NCT00282295|O2|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326652|NCT00282295|O1|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326653|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326654|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326655|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326903|NCT00291161|B3|Baseline|Caregivers-PDC Group|Caregivers to veterans with diagnosed dementia receiving the PDC Intervention
328367|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
326656|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326657|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326658|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326659|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326660|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326661|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326662|NCT00282295|O1|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326663|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326664|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326665|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326666|NCT00282295|O2|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326697|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326854|NCT00282672|O3|Outcome|HGD to IMC|
326667|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326668|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326669|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326670|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326671|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326672|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326673|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326674|NCT00282295|E3|Reported Event|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326675|NCT00282295|E2|Reported Event|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
326676|NCT00282295|E1|Reported Event|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
326677|NCT00282308|B3|Baseline|Total|Total of all reporting groups
326678|NCT00282308|B2|Baseline|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326679|NCT00282308|B1|Baseline|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326904|NCT00291161|B2|Baseline|Veterans-Usual Care Comparison Group|Veterans with diagnosed dementia receiving educational materials and usual care
326680|NCT00282308|P3|Participant Flow|All Patients (Combined Groups A and B)|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab. Patients received no treatment during the Safety Follow-up Period.
326681|NCT00282308|P2|Participant Flow|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326682|NCT00282308|P1|Participant Flow|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326683|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326684|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326685|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326686|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326687|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326688|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326689|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326690|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326691|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326692|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326693|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326694|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326695|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326696|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326698|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326704|NCT00282308|E4|Reported Event|Group B - Optional Extension Re-treatment Period|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
326705|NCT00282308|E3|Reported Event|Group A - Optional Extension Re-treatment Period|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
326706|NCT00282308|E2|Reported Event|Methotrexate (Group B) - Treatment Period|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326707|NCT00282308|E1|Reported Event|Rituximab + Methotrexate (Group A) - Treatment Period|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
326708|NCT00282334|B3|Baseline|Total|Total of all reporting groups
326709|NCT00282334|B2|Baseline|Telemonitoring of Home Blood Press|
326710|NCT00282334|B1|Baseline|Conventional Blood Pressure Monitoring|
326711|NCT00282334|P2|Participant Flow|Conventional|Conventional blood pressure monitoring
326712|NCT00282334|P1|Participant Flow|Telemonitoring|Telemonitoring of home blood pressure
326713|NCT00282334|O2|Outcome|Telemonitoring of Home Blood Press|
326714|NCT00282334|O1|Outcome|Conventional Blood Pressure Monitoring|
326715|NCT00282334|E2|Reported Event|Telemonitoring of Home Blood Press|
326716|NCT00282334|E1|Reported Event|Conventional Blood Pressure Monitoring|
326717|NCT00282347|B3|Baseline|Total|Total of all reporting groups
326718|NCT00282347|B2|Baseline|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326719|NCT00282347|B1|Baseline|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326720|NCT00282347|P2|Participant Flow|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326721|NCT00282347|P1|Participant Flow|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326722|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326905|NCT00291161|B1|Baseline|Veterans-PDC Group|Veterans with diagnosed dementia receiving the PDC Intervention
326723|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326724|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326725|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326726|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326727|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326728|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326729|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326730|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326731|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326732|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326733|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326734|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326735|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326736|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326737|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326738|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326739|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326740|NCT00282347|E4|Reported Event|Placebo - B Cell Follow-up Period|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326741|NCT00282347|E3|Reported Event|Rituximab - B Cell Follow-up Period|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326742|NCT00282347|E2|Reported Event|Placebo - Treatment and Safety Follow-up Periods|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326743|NCT00282347|E1|Reported Event|Rituximab - Treatment and Safety Follow-up Periods|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
326744|NCT00282438|B3|Baseline|Total|Total of all reporting groups
326745|NCT00282438|B2|Baseline|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning
Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
326746|NCT00282438|B1|Baseline|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning
Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
326747|NCT00282438|P2|Participant Flow|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning
Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
326748|NCT00282438|P1|Participant Flow|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning
Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
326749|NCT00282438|O2|Outcome|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning
Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
326750|NCT00282438|O1|Outcome|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning
Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
326751|NCT00282438|E2|Reported Event|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning
Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
326752|NCT00282438|E1|Reported Event|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning
Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
326753|NCT00282464|B3|Baseline|Total|Total of all reporting groups
326754|NCT00282464|B2|Baseline|Placebo|
326755|NCT00282464|B1|Baseline|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326756|NCT00282464|P2|Participant Flow|Placebo|
326757|NCT00282464|P1|Participant Flow|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326758|NCT00282464|O2|Outcome|Placebo|
326759|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326760|NCT00282464|O2|Outcome|Placebo|
326761|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326762|NCT00282464|O2|Outcome|Placebo|
326763|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326764|NCT00282464|O2|Outcome|Placebo|
326765|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326766|NCT00282464|O2|Outcome|Placebo|
326855|NCT00282672|O2|Outcome|LGD to IMC|
326856|NCT00282672|O1|Outcome|LGD to HGD|
326767|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326768|NCT00282464|O2|Outcome|Placebo|
326769|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326770|NCT00282464|O2|Outcome|Placebo|
326771|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326772|NCT00282464|O2|Outcome|Placebo|
326773|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326774|NCT00282464|O2|Outcome|Placebo|
326775|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326776|NCT00282464|O2|Outcome|Placebo|
326777|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326778|NCT00282464|O2|Outcome|Placebo|
326779|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326780|NCT00282464|O2|Outcome|Placebo|
326906|NCT00291161|P4|Participant Flow|Caregivers: Usual Care Comparison|Caregivers of the Veterans assigned to the Usual Care Comparison
326781|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326782|NCT00282464|O2|Outcome|Placebo|
326783|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326784|NCT00282464|O2|Outcome|Placebo|
326785|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326786|NCT00282464|O2|Outcome|Placebo|
326787|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326788|NCT00282464|O2|Outcome|Placebo|
326789|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326790|NCT00282464|O2|Outcome|Placebo|
326791|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326792|NCT00282464|O2|Outcome|Placebo|
326793|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326794|NCT00282464|O2|Outcome|Placebo|
326795|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326796|NCT00282464|O2|Outcome|Placebo|
326857|NCT00282672|O4|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
326858|NCT00282672|O3|Outcome|HGD Radiofrequency Ablation|
326859|NCT00282672|O2|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
326797|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326798|NCT00282464|O2|Outcome|Placebo|
326799|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326800|NCT00282464|O2|Outcome|Placebo|
326801|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326802|NCT00282464|E2|Reported Event|Placebo|
326803|NCT00282464|E1|Reported Event|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
326804|NCT00282568|B1|Baseline|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326805|NCT00282568|P1|Participant Flow|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326806|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326807|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326808|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326809|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326810|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326860|NCT00282672|O1|Outcome|LGD Radiofrequency Ablation|
326861|NCT00282672|O2|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
326862|NCT00282672|O1|Outcome|HGD Radiofrequency Ablation|
326863|NCT00282672|O4|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
326864|NCT00282672|O3|Outcome|HGD Radiofrequency Ablation|
326865|NCT00282672|O2|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
326811|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326812|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326813|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326814|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326907|NCT00291161|P3|Participant Flow|Caregivers: Partners in Dementia Care Intervention|Caregivers for Veterans assigned to the Partners in Dementia Care Intervention
326908|NCT00291161|P2|Participant Flow|Veterans: Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
327459|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
326815|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326816|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326817|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326818|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326819|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326820|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326866|NCT00282672|O1|Outcome|LGD Radiofrequency Ablation|
326867|NCT00282672|O2|Outcome|All HGD Patients|HGD: Sham procedure group crossed over to HGD: Radiofrequency group at 12 month
328628|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
326821|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326822|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326823|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326824|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326825|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326826|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326827|NCT00282568|E1|Reported Event|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
326828|NCT00282672|B5|Baseline|Total|Total of all reporting groups
326829|NCT00282672|B4|Baseline|HGD Radiofrequency Ablation|
326830|NCT00282672|B3|Baseline|HGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
326831|NCT00282672|B2|Baseline|LGD Radiofrequency Ablation|
326832|NCT00282672|B1|Baseline|LGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
326833|NCT00282672|P4|Participant Flow|HGD Radiofrequency Ablation|
326834|NCT00282672|P3|Participant Flow|HGD Sham Procedure First Then HGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
326835|NCT00282672|P2|Participant Flow|LGD Radiofrequency Ablation|
326836|NCT00282672|P1|Participant Flow|LGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
326837|NCT00282672|O2|Outcome|All HGD Patients|
326838|NCT00282672|O1|Outcome|All LGD Patients|
326839|NCT00282672|O1|Outcome|All Groups|
326840|NCT00282672|O1|Outcome|All Study Participants|
326841|NCT00282672|O1|Outcome|All Groups|
326842|NCT00282672|O1|Outcome|All Groups|
326843|NCT00282672|O1|Outcome|All Groups|
326844|NCT00282672|O1|Outcome|All Groups|
326845|NCT00282672|O1|Outcome|All Groups|
326846|NCT00282672|O1|Outcome|All Groups|
326847|NCT00282672|O1|Outcome|All Groups|
326848|NCT00282672|O1|Outcome|All Groups|
326849|NCT00282672|O4|Outcome|HGD Radiofrequency Ablation|
326850|NCT00282672|O3|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
326851|NCT00282672|O2|Outcome|LGD Radiofrequency Ablation|
326852|NCT00282672|O1|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
326853|NCT00282672|O1|Outcome|All Groups|
326872|NCT00282672|O1|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|Crossed over to LGD:Radiofrequency
326873|NCT00282672|O2|Outcome|HGD:Radiofrequency|
326874|NCT00282672|O1|Outcome|LGD:Radiofrequency|
326875|NCT00282672|O2|Outcome|HGD:Radiofrequency Ablation|
326876|NCT00282672|O1|Outcome|LGD:Radiofrequency Ablation|
326877|NCT00282672|E4|Reported Event|HGD Radiofrequency Ablation|
326878|NCT00282672|E3|Reported Event|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
326879|NCT00282672|E2|Reported Event|LGD Radiofrequency Ablation|
326880|NCT00282672|E1|Reported Event|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
326881|NCT00288509|B1|Baseline|Dysport|250-1000 units
326882|NCT00288509|P1|Participant Flow|Dysport|250-1000 units
326883|NCT00288509|O1|Outcome|Dysport|250-1000 units
326884|NCT00288509|O1|Outcome|Dysport|250-1000 units
326885|NCT00288509|O1|Outcome|Dysport|250-1000 units
326886|NCT00288509|O1|Outcome|Dysport|250-1000 units
326887|NCT00288509|E1|Reported Event|Dysport|250-1000 units
326888|NCT00288574|B3|Baseline|Total|Total of all reporting groups
326889|NCT00288574|B2|Baseline|Placebo|Placebo group
326890|NCT00288574|B1|Baseline|Fluoxetine|"fluoxetine up to 80 mg per day
Fluoxetine"
326891|NCT00288574|P2|Participant Flow|Placebo|Placebo group
326892|NCT00288574|P1|Participant Flow|Fluoxetine|"fluoxetine up to 80 mg per day
Fluoxetine"
326893|NCT00288574|O2|Outcome|Placebo|Placebo group
326894|NCT00288574|O1|Outcome|Fluoxetine|"fluoxetine up to 80 mg per day
Fluoxetine"
326895|NCT00288574|E2|Reported Event|Placebo|Placebo Medication
326896|NCT00288574|E1|Reported Event|Fluoxetine|"fluoxetine up to 80 mg per day
Fluoxetine"
326897|NCT00291135|B1|Baseline|Letrozole|Letrozole, 2.5 mg daily for six months
326898|NCT00291135|P1|Participant Flow|Letrozole|Letrozole, 2.5 mg daily for six months
326899|NCT00291135|O1|Outcome|Letrozole|Letrozole, 2.5 mg daily for six months
326900|NCT00291135|E1|Reported Event|Letrozole|Letrozole, 2.5 mg daily for six months
326901|NCT00291161|B5|Baseline|Total|Total of all reporting groups
327460|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
326909|NCT00291161|P1|Participant Flow|Veterans: Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
326910|NCT00291161|O2|Outcome|Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
326911|NCT00291161|O1|Outcome|Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
326912|NCT00291161|O2|Outcome|Caregivers: Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
326913|NCT00291161|O1|Outcome|Caregivers: Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
326914|NCT00291161|E2|Reported Event|Veterans-Usual Care Comparison Group|Veterans with diagnosed dementia receiving educational materials and usual care
326915|NCT00291161|E1|Reported Event|Veterans-PDC Group|Veterans with diagnosed dementia receiving the PDC Intervention
326916|NCT00291187|B5|Baseline|Total|Total of all reporting groups
326917|NCT00291187|B4|Baseline|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
326918|NCT00291187|B3|Baseline|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
326919|NCT00291187|B2|Baseline|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
326920|NCT00291187|B1|Baseline|Placebo|Taken orally 30 minutes prior to bedtime.
326921|NCT00291187|P4|Participant Flow|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime
326922|NCT00291187|P3|Participant Flow|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime
326923|NCT00291187|P2|Participant Flow|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime
326924|NCT00291187|P1|Participant Flow|Placebo|taken orally 30 minutes prior to bedtime
326925|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
326927|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
326928|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime
326929|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
326930|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
326931|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
326932|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
326933|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime
326934|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime
326935|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime
326936|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
326937|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
326938|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
326939|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
326940|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
326941|NCT00291187|E4|Reported Event|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
326942|NCT00291187|E3|Reported Event|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
326943|NCT00291187|E2|Reported Event|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
326944|NCT00291187|E1|Reported Event|Placebo|Taken orally 30 minutes prior to bedtime.
326945|NCT00291226|B3|Baseline|Total|Total of all reporting groups
326946|NCT00291226|B2|Baseline|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.
Placebo: Placebo"
326947|NCT00291226|B1|Baseline|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.
Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.
Glycine: Glycine 0.4 g/kg bid"
326948|NCT00291226|P2|Participant Flow|Placebo Group|Glycine and placebo dosing group.
326949|NCT00291226|P1|Participant Flow|Glycine|Glycine dosing group.
327461|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
326950|NCT00291226|O2|Outcome|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.
Placebo: Placebo"
326951|NCT00291226|O1|Outcome|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.
Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.
Glycine: Glycine 0.4 g/kg bid"
326952|NCT00291226|O2|Outcome|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.
Placebo: Placebo"
326953|NCT00291226|O1|Outcome|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.
Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.
Glycine: Glycine 0.4 g/kg bid"
326954|NCT00291226|E2|Reported Event|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.
Placebo: Placebo"
327083|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
326955|NCT00291226|E1|Reported Event|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.
Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.
Glycine: Glycine 0.4 g/kg bid"
326956|NCT00291317|B1|Baseline|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
326957|NCT00291317|P1|Participant Flow|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
326958|NCT00291317|O1|Outcome|DEXA|
326959|NCT00291317|O1|Outcome|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
326960|NCT00291317|E1|Reported Event|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
326961|NCT00291330|B3|Baseline|Total|Total of all reporting groups
326962|NCT00291330|B2|Baseline|Warfarin|PRN to maintain an INR of 2.0-3.0
326963|NCT00291330|B1|Baseline|Dabigatran 150 mg|bid (twice daily) oral
326964|NCT00291330|P2|Participant Flow|Warfarin|PRN to maintain an INR of 2.0-3.0
326965|NCT00291330|P1|Participant Flow|Dabigatran 150 mg|bid (twice daily) oral
326966|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
326967|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
326968|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
326969|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
326970|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
326971|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
326972|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
326973|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
326974|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
326975|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
326976|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
326977|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
326978|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
326979|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
326980|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
326981|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
326982|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
326983|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
326984|NCT00291330|E2|Reported Event|Warfarin|PRN to maintain an INR of 2.0-3.0
326985|NCT00291330|E1|Reported Event|Dabigatran 150 mg|bid (twice daily) oral
326986|NCT00291343|B3|Baseline|Total|Total of all reporting groups
326987|NCT00291343|B2|Baseline|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
326988|NCT00291343|B1|Baseline|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
326989|NCT00291343|P2|Participant Flow|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
326990|NCT00291343|P1|Participant Flow|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
326991|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
326992|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
326993|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
326994|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327034|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
326995|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
326996|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
326997|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
326998|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
326999|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327000|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327001|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327002|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327003|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327286|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
327004|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327005|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327006|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327007|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327008|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327009|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327010|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327011|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327012|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327013|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327014|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327015|NCT00291343|E2|Reported Event|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327016|NCT00291343|E1|Reported Event|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
327017|NCT00291551|B1|Baseline|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
327018|NCT00291551|P1|Participant Flow|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
327019|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
327020|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
327021|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
327022|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
327023|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
327024|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
327025|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
327026|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
327027|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
327028|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
327029|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
327030|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
327031|NCT00291551|E1|Reported Event|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
327032|NCT00291577|B1|Baseline|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327033|NCT00291577|P1|Participant Flow|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327053|NCT00291655|O1|Outcome|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
327035|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327036|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327037|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327038|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327039|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327040|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327041|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327042|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327043|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327287|NCT00292461|E2|Reported Event|Lamotrigine|once daily orally for 16 weeks
327044|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327045|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327046|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327047|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327048|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327049|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327050|NCT00291577|E1|Reported Event|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
327051|NCT00291655|B1|Baseline|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
327052|NCT00291655|P1|Participant Flow|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
327055|NCT00291655|E1|Reported Event|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
327056|NCT00291694|B3|Baseline|Total|Total of all reporting groups
327057|NCT00291694|B2|Baseline|Placebo|Placebo for six months
327058|NCT00291694|B1|Baseline|Celecoxib|Celecoxib for six months
327059|NCT00291694|P2|Participant Flow|Celecoxib|Celecoxib for 12 months
327060|NCT00291694|P1|Participant Flow|Placebo|Placebo for 12 months
327061|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months
placebo: placebo"
327062|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months
celecoxib: Celecoxib 400 mg BID"
327063|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months
placebo: placebo"
327064|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months
celecoxib: Celecoxib 400 mg BID"
327065|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months
placebo: placebo"
327066|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months
celecoxib: Celecoxib 400 mg BID"
327067|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months
placebo: placebo"
327068|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months
celecoxib: Celecoxib 400 mg BID"
327069|NCT00291694|O2|Outcome|Placebo|Randomized to receive placebo daily for 12 months
327070|NCT00291694|O1|Outcome|Celecoxib|Randomized to receive celecoxib daily for 12 months
327071|NCT00291694|E2|Reported Event|Placebo|Randomized to receive palcebo daily for 12 months
327072|NCT00291694|E1|Reported Event|Celecoxib|Randomized to receive celecoxib daily for 12 months
327073|NCT00291876|B1|Baseline|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
327074|NCT00291876|P1|Participant Flow|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
327075|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
327076|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
327077|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
327078|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
327079|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
327080|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
327081|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
327082|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
327084|NCT00291876|E1|Reported Event|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
327085|NCT00292162|B3|Baseline|Total|Total of all reporting groups
327086|NCT00292162|B2|Baseline|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
327087|NCT00292162|B1|Baseline|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
327088|NCT00292162|P2|Participant Flow|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
327089|NCT00292162|P1|Participant Flow|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
327090|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
327091|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
327092|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
327093|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
327094|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
327116|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327517|NCT00293267|P2|Participant Flow|Placebo + OBT|
327095|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
327096|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
327097|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
327098|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
327099|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
327100|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
327101|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
327102|NCT00292162|E2|Reported Event|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
327103|NCT00292162|E1|Reported Event|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
327104|NCT00292188|B3|Baseline|Total|Total of all reporting groups
327105|NCT00292188|B2|Baseline|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327175|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327106|NCT00292188|B1|Baseline|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327107|NCT00292188|P3|Participant Flow|Double-Blind Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327108|NCT00292188|P2|Participant Flow|Double-Blind Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327109|NCT00292188|P1|Participant Flow|Single-Blind Placebo|All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
327110|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327111|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327112|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327113|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327114|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327115|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327447|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327117|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327118|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327119|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327120|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327121|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327122|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327123|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327124|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327125|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327126|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327127|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327128|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327129|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327130|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327131|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327132|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327133|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327134|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327135|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327136|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327137|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327138|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327139|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327140|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327141|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327142|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327143|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327144|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327145|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327146|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327147|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327148|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327149|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327150|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327151|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327152|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327153|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327154|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327155|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327156|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327157|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327158|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327159|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327160|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327161|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327162|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327163|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327164|NCT00292188|E3|Reported Event|Double-Blind Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
327165|NCT00292188|E2|Reported Event|Double-Blind Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).
At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
327166|NCT00292188|E1|Reported Event|Single-Blind Placebo|All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
327167|NCT00292227|B3|Baseline|Total|Total of all reporting groups
327168|NCT00292227|B2|Baseline|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327169|NCT00292227|B1|Baseline|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327170|NCT00292227|P3|Participant Flow|Placebo Patch (Infusion: Placebo-Moxifloxacin)|Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 39.
327171|NCT00292227|P2|Participant Flow|Placebo Patch (Infusion: Moxifloxacin-Placebo)|Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 32. Placebo saline solution 250 mL infused over 1 hour on Day 39.
327172|NCT00292227|P1|Participant Flow|Rotigotine Patch (Infusion: Placebo-Placebo)|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32 and on Day 39.
327173|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327174|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327176|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327177|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327178|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327179|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327180|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327181|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327182|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327183|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327184|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327185|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327186|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327187|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327188|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327189|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327190|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327191|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327192|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327193|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327194|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327195|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327196|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327197|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
327198|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
327448|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327199|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327200|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327201|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327202|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327203|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327204|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327205|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327206|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327207|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327208|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327209|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327210|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327211|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327212|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327213|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327214|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327215|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327216|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327217|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327218|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327279|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
327219|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327220|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327221|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327222|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327223|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327224|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327225|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327226|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327227|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327228|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327229|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327230|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327231|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327232|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327233|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327234|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327235|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327236|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327449|NCT00293241|O2|Outcome|MVP Off|Managed Ventricular Pacing programmed off: conventional pacing
327237|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327238|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327239|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327240|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327241|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327242|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327243|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327244|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327245|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327246|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327247|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327248|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327249|NCT00292227|E2|Reported Event|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327250|NCT00292227|E1|Reported Event|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
327251|NCT00292318|B3|Baseline|Total|Total of all reporting groups
327252|NCT00292318|B2|Baseline|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.
Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
327253|NCT00292318|B1|Baseline|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.
control group: Medical counseling and ano-sphinctal exercises."
327280|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
327281|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
327282|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
327283|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
327284|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
327254|NCT00292318|P2|Participant Flow|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.
Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
327255|NCT00292318|P1|Participant Flow|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.
control group: Medical counseling and ano-sphinctal exercises."
327256|NCT00292318|O2|Outcome|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.
Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
327257|NCT00292318|O1|Outcome|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.
control group: Medical counseling and ano-sphinctal exercises."
327258|NCT00292318|O2|Outcome|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.
Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
327259|NCT00292318|O1|Outcome|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.
control group: Medical counseling and ano-sphinctal exercises."
327260|NCT00292318|E2|Reported Event|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.
Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
327261|NCT00292318|E1|Reported Event|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.
control group: Medical counseling and ano-sphinctal exercises."
327262|NCT00292370|B4|Baseline|Total|Total of all reporting groups
327450|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327518|NCT00293267|P1|Participant Flow|Raltegravir 400 mg b.i.d. + OBT|
327263|NCT00292370|B3|Baseline|Arm 3/OL Paroxetine & Double-blind Quetiapine|"Phase II: Double-blind quetiapine
In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine in a double-blind fashion."
327264|NCT00292370|B2|Baseline|Arm 2/OL Paroxetine & Double-blind Placebo|"Phase II: Double-blind placebo
In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."
327265|NCT00292370|B1|Baseline|Arm 1/Open-Label (OL) Paroxetine|"Phase I : Open-label Paroxetine
In Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"
327266|NCT00292370|P3|Participant Flow|Arm 3/OL Paroxetine & Double-blind Quetiapine|"Phase II : Double-blind quetiapine
In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine for 8 weeks in a double-blind fashion."
327267|NCT00292370|P2|Participant Flow|Arm 2/OL Paroxetine & Double-blind Placebo|"Phase II : Double-blind placebo
In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."
327268|NCT00292370|P1|Participant Flow|Arm 1/Open-Label (OL) Paroxetine|"Phase I : Open-label Paroxetine
In Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"
327269|NCT00292370|O2|Outcome|Arm 3: OL Paroxetine + DB Quetiapine|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine"
327270|NCT00292370|O1|Outcome|Arm 2 OL Paroxetine + DB Placebo|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine"
327271|NCT00292370|E3|Reported Event|Arm 3: OL Paroxetine + DB Quetiapine|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Quetiapine: Double-blind quetiapine taken with OL paroxetine"
327272|NCT00292370|E2|Reported Event|Arm 2 OL Paroxetine + DB Placebo|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.
Open Label (OL) Paroxetine: Open-label Paroxetine
Placebo: Double-blind placebo taken with OL paroxetine"
327273|NCT00292370|E1|Reported Event|Arm 1: Open Label (OL) Paroxetine|"In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.
Open Label (OL) Paroxetine: Open-label Paroxetine"
327274|NCT00292461|B3|Baseline|Total|Total of all reporting groups
327275|NCT00292461|B2|Baseline|Lamotrigine|once daily orally for 16 weeks
327276|NCT00292461|B1|Baseline|Zonegran|once or twice daily orally for 16 weeks
327277|NCT00292461|P2|Participant Flow|Lamotrigine|once daily orally for 16 weeks
327278|NCT00292461|P1|Participant Flow|Zonegran|once or twice daily orally for 16 weeks
327288|NCT00292461|E1|Reported Event|Zonegran|once or twice daily orally for 16 weeks
327289|NCT00292591|B4|Baseline|Total|Total of all reporting groups
327290|NCT00292591|B3|Baseline|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327291|NCT00292591|B2|Baseline|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327292|NCT00292591|B1|Baseline|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327293|NCT00292591|P3|Participant Flow|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327294|NCT00292591|P2|Participant Flow|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327295|NCT00292591|P1|Participant Flow|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327296|NCT00292591|O3|Outcome|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327297|NCT00292591|O2|Outcome|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327451|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327452|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327298|NCT00292591|O1|Outcome|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327299|NCT00292591|E3|Reported Event|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327300|NCT00292591|E2|Reported Event|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327301|NCT00292591|E1|Reported Event|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day
cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
327302|NCT00292981|B1|Baseline|C1 Esterase Inhibitor|
327303|NCT00292981|P1|Participant Flow|C1 Esterase Inhibitor|
327304|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
327305|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
327306|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
327307|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
327308|NCT00292981|E1|Reported Event|C1 Esterase Inhibitor|
327309|NCT00293020|B1|Baseline|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
327310|NCT00293020|P1|Participant Flow|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
327311|NCT00293020|O1|Outcome|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
327312|NCT00293020|E1|Reported Event|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
327313|NCT00293059|B3|Baseline|Total|Total of all reporting groups
327314|NCT00293059|B2|Baseline|Placebo|Matching placebo to be taken orally daily
327315|NCT00293059|B1|Baseline|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327316|NCT00293059|P2|Participant Flow|Placebo|Matching placebo to be taken orally daily
327317|NCT00293059|P1|Participant Flow|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327318|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327319|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327320|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327321|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327322|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327323|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327324|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327325|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327326|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327327|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327328|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327329|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327330|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327331|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327332|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327333|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327334|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327335|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327336|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
328368|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
327337|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327338|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327339|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327340|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327341|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327342|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327343|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327344|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327345|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327346|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327347|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327348|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327349|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327350|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327351|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327352|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327353|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327354|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327355|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327356|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327632|NCT00279955|B3|Baseline|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
327357|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327358|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327359|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327360|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327361|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327362|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327363|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327364|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327365|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327366|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327367|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327368|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327369|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327370|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327371|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327372|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327373|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327374|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327375|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327376|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327377|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327378|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327379|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327380|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327381|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327382|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327383|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327384|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327385|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327386|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327387|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327388|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327389|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327390|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327706|NCT00280150|O1|Outcome|Overall Study|All 45 patients were included in the summary of efficacy outcomes.
327707|NCT00280150|O1|Outcome|Overall Study|This includes patients from all cohorts.
327391|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327392|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327393|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327394|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327395|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327396|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327397|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327398|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327399|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327400|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327401|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327402|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327403|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327404|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327405|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327406|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327407|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327408|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327409|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327410|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327411|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327412|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327413|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327414|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327415|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327416|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327417|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327418|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327419|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327420|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327421|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327422|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327423|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327424|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
327708|NCT00280150|O1|Outcome|Overall Study|This includes patients from all cohorts.
327709|NCT00280150|O2|Outcome|Concurrent Therapy|Percentage of all patients receiving concurrent therapy
327425|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327426|NCT00293059|E2|Reported Event|Placebo|Matching placebo to be taken orally daily
327427|NCT00293059|E1|Reported Event|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
327428|NCT00293241|B3|Baseline|Total|Total of all reporting groups
327429|NCT00293241|B2|Baseline|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327430|NCT00293241|B1|Baseline|MVP ON|Managed Ventricular Pacing programmed on
327431|NCT00293241|P2|Participant Flow|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327432|NCT00293241|P1|Participant Flow|MVP ON|Managed Ventricular Pacing programmed on
327433|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327434|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327435|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327436|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327437|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327438|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327439|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327440|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327441|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327442|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327443|NCT00293241|O2|Outcome|MVP OFF|"Managed Ventricular Pacing programmed off: conventional pacing
Managed Ventricular Pacing programmed ON/OFF: Device programming"
327444|NCT00293241|O1|Outcome|MVP ON|"Managed Ventricular Pacing programmed on
Managed Ventricular Pacing programmed ON/OFF: Device programming"
327445|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327446|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327462|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327463|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327464|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327465|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327466|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327467|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327468|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327469|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327470|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
327471|NCT00293241|E2|Reported Event|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
327472|NCT00293241|E1|Reported Event|MVP ON|Managed Ventricular Pacing programmed on
327473|NCT00293254|B3|Baseline|Total|Total of all reporting groups
327474|NCT00293254|B2|Baseline|Placebo + OBT|
327475|NCT00293254|B1|Baseline|Raltegravir 400 mg b.i.d. + OBT|
327476|NCT00293254|P2|Participant Flow|Placebo + OBT|
327477|NCT00293254|P1|Participant Flow|Raltegravir 400 mg b.i.d. + OBT|
327478|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
327479|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
327480|NCT00293254|O2|Outcome|Placebo + OBT|
327481|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327482|NCT00293254|O2|Outcome|Placebo + OBT|
327483|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327484|NCT00293254|O2|Outcome|Placebo + OBT|
327485|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327486|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
327487|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
327488|NCT00293254|O2|Outcome|Placebo + OBT|
327489|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327490|NCT00293254|O2|Outcome|Placebo + OBT|
327491|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327492|NCT00293254|O2|Outcome|Placebo + OBT|
327493|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327494|NCT00293254|O2|Outcome|Placebo + OBT|
327495|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327496|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
327497|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
327498|NCT00293254|O2|Outcome|Placebo + OBT|
327499|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327500|NCT00293254|O2|Outcome|Placebo + OBT|
327501|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327502|NCT00293254|O2|Outcome|Placebo + OBT|
327503|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327504|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
327505|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
327506|NCT00293254|O2|Outcome|Placebo + OBT|
327507|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327508|NCT00293254|O2|Outcome|Placebo + OBT|
327509|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327510|NCT00293254|O2|Outcome|Placebo + OBT|
327511|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327512|NCT00293254|E2|Reported Event|Placebo Plus OBT|Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
327513|NCT00293254|E1|Reported Event|Raltegravir 400 mg b.i.d. Plus OBT|"Includes all participants initially randomized to raltegravir, including those without virologic failure who
continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT."
327514|NCT00293267|B3|Baseline|Total|Total of all reporting groups
327515|NCT00293267|B2|Baseline|Placebo + OBT|
327516|NCT00293267|B1|Baseline|Raltegravir 400 mg b.i.d. + OBT|
327519|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
327520|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
327521|NCT00293267|O2|Outcome|Placebo + OBT|
327522|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327523|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
327524|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
327525|NCT00293267|O2|Outcome|Placebo + OBT|
327526|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327527|NCT00293267|O2|Outcome|Placebo + OBT|
327528|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327529|NCT00293267|O2|Outcome|Placebo + OBT|
327530|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327531|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
327572|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327532|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
327533|NCT00293267|O2|Outcome|Placebo + OBT|
327534|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327535|NCT00293267|O2|Outcome|Placebo + OBT|
327536|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327537|NCT00293267|O2|Outcome|Placebo + OBT|
327538|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327539|NCT00293267|O2|Outcome|Placebo + OBT|
327540|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327541|NCT00293267|O2|Outcome|Placebo + OBT|
327542|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327543|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
327544|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
327545|NCT00293267|O2|Outcome|Placebo + OBT|
327546|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327547|NCT00293267|O2|Outcome|Placebo + OBT|
327548|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327549|NCT00293267|O2|Outcome|Placebo + OBT|
327550|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327551|NCT00293267|O2|Outcome|Placebo + OBT|
327552|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
327553|NCT00293267|E2|Reported Event|Placebo Plus OBT|Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
327554|NCT00293267|E1|Reported Event|Raltegravir 400 mg b.i.d Plus OBT|"Includes all participants initially randomized to raltegravir, including those without virologic failure who
continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT."
327555|NCT00293293|B3|Baseline|Total|Total of all reporting groups
327556|NCT00293293|B2|Baseline|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327557|NCT00293293|B1|Baseline|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327558|NCT00293293|P2|Participant Flow|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327559|NCT00293293|P1|Participant Flow|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327560|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327561|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327562|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327563|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327564|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327565|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327566|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327567|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327568|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327569|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327570|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327571|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327573|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327574|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327575|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327576|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327577|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327578|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327579|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327580|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327581|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327582|NCT00293293|E2|Reported Event|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
327583|NCT00293293|E1|Reported Event|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
327584|NCT00293384|B1|Baseline|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3
Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
327585|NCT00293384|P1|Participant Flow|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3
Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
327586|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3
Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
327609|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327811|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327587|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3
Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
327588|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3
Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
327589|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3
Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
327590|NCT00293384|E1|Reported Event|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3
Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
327591|NCT00293462|B4|Baseline|Total|Total of all reporting groups
327592|NCT00293462|B3|Baseline|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
327593|NCT00293462|B2|Baseline|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327594|NCT00293462|B1|Baseline|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327595|NCT00293462|P3|Participant Flow|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327596|NCT00293462|P2|Participant Flow|Arm II: Salt & Soda Group (SS)|Arm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327597|NCT00293462|P1|Participant Flow|Arm I: GM-CSF Group (GG)|Arm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327598|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
327599|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327600|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327601|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
327602|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327603|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327604|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
327605|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327606|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327607|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
327608|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327761|NCT00293813|P3|Participant Flow|Placebo|Placebo
327762|NCT00293813|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
327610|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327611|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327612|NCT00293462|E3|Reported Event|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
327613|NCT00293462|E2|Reported Event|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327614|NCT00293462|E1|Reported Event|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
327615|NCT00293540|B3|Baseline|Total|Total of all reporting groups
327616|NCT00293540|B2|Baseline|B Mid-follicular Surgery|
327617|NCT00293540|B1|Baseline|A Mid-luteal Surgery|
327618|NCT00293540|P2|Participant Flow|B Mid-follicular Surgery|
327619|NCT00293540|P1|Participant Flow|A Mid-luteal Surgery|
327620|NCT00293540|O2|Outcome|B Mid-follicular Surgery|
327621|NCT00293540|O1|Outcome|A Mid-luteal Surgery|
327622|NCT00293540|E2|Reported Event|B Mid-follicular Surgery|
327623|NCT00293540|E1|Reported Event|A Mid-luteal Surgery|
327624|NCT00293579|B1|Baseline|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
327625|NCT00293579|P1|Participant Flow|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
327626|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
327627|NCT00293579|O1|Outcome|Pemetrexed|"pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
Pemetrexed: 500 mg/m2 IV every 3 weeks for 6 cycles"
327628|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
327629|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
327630|NCT00293579|E1|Reported Event|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
327633|NCT00279955|B2|Baseline|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327634|NCT00279955|B1|Baseline|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327635|NCT00279955|P3|Participant Flow|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
327636|NCT00279955|P2|Participant Flow|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327637|NCT00279955|P1|Participant Flow|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327638|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327639|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327640|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327641|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327642|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327643|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327644|NCT00279955|E3|Reported Event|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
327645|NCT00279955|E2|Reported Event|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327646|NCT00279955|E1|Reported Event|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
327647|NCT00280059|B3|Baseline|Total|Total of all reporting groups
327648|NCT00280059|B2|Baseline|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327649|NCT00280059|B1|Baseline|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327650|NCT00280059|P2|Participant Flow|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327651|NCT00280059|P1|Participant Flow|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327652|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327653|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327654|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327710|NCT00280150|O1|Outcome|Induction Therapy|Percentage of all patients receiving induction therapy
327711|NCT00280150|O4|Outcome|Phase II|Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
328629|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
327655|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327656|NCT00280059|O8|Outcome|Lamotrigine 500 mg/Day|Lamotrigine 500 mg/day administered BID
327657|NCT00280059|O7|Outcome|Lamotrigine 400 mg/Day|Lamotrigine 400 mg/day administered BID
327658|NCT00280059|O6|Outcome|Lamotrigine 200 mg/Day|Lamotrigine 200 mg/day administered BID
327659|NCT00280059|O5|Outcome|Lamotrigine 100 mg/Day|Lamotrigine 100 mg/day administered BID
327660|NCT00280059|O4|Outcome|Pregabalin 600 mg/Day|Pregabalin 600 mg/day administered BID
327661|NCT00280059|O3|Outcome|Pregabalin 450 mg/Day|Pregabalin 450 mg/day administered BID
327662|NCT00280059|O2|Outcome|Pregabalin 300 mg/Day|Pregabalin 300 mg/day administered BID
327663|NCT00280059|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 150 mg/day administered twice daily (BID)
327664|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327665|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327666|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327667|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327668|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327669|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327670|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327671|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327763|NCT00293813|P1|Participant Flow|Alendronate 70 mg QW|Alendronate 70 mg QW
327672|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327673|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327674|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327675|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327676|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327677|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327678|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327679|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
328630|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
327680|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327681|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327682|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327683|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327684|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327685|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327686|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327687|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327688|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327689|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327690|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327764|NCT00293813|O3|Outcome|Placebo|Placebo
327765|NCT00293813|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
327691|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327692|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327693|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327694|NCT00280059|E2|Reported Event|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327695|NCT00280059|E1|Reported Event|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
327696|NCT00280150|B5|Baseline|Total|Total of all reporting groups
327697|NCT00280150|B4|Baseline|Phase II|Bevacizumab + Erlotinib100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
327698|NCT00280150|B3|Baseline|Cohort 3|Bevacizumab + Erlotinib 150 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
327699|NCT00280150|B2|Baseline|Cohort 2|Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
327700|NCT00280150|B1|Baseline|Cohort 1|Bevacizumab 10 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
327701|NCT00280150|P4|Participant Flow|Phase II|Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
327702|NCT00280150|P3|Participant Flow|Cohort 3|Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
327703|NCT00280150|P2|Participant Flow|Cohort 2|Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
327704|NCT00280150|P1|Participant Flow|Cohort 1|Bevacizumab 10 mg + Chemoradiotherapy
327705|NCT00280150|O1|Outcome|Overall Study|This includes patients from all cohorts.
327712|NCT00280150|O3|Outcome|Cohort 3|Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
327713|NCT00280150|O2|Outcome|Cohort 2|Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
327714|NCT00280150|O1|Outcome|Cohort 1|Bevacizumab 10 mg + Chemoradiotherapy
327715|NCT00280150|E1|Reported Event|Overall Study|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients. This includes patients from all cohorts.
327716|NCT00285649|B4|Baseline|Total|Total of all reporting groups
327717|NCT00285649|B3|Baseline|Usual Medical Care|"Usual Medical Care, Active Comparator, advice, exercises and medications
Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
327718|NCT00285649|B2|Baseline|LVVA-SM|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
327719|NCT00285649|B1|Baseline|HVLA-SM|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
327720|NCT00285649|P3|Participant Flow|Usual Medical Care|"Usual Medical Care, Active Comparator, advice, exercises and medications
Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
327721|NCT00285649|P2|Participant Flow|LVVA-SM|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
327722|NCT00285649|P1|Participant Flow|HVLA-SM|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
327723|NCT00285649|O3|Outcome|Usual Medical Care|"Usual Medical Care, Active Comparator, advice, exercises and medications
Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
327724|NCT00285649|O2|Outcome|LVVA-SM|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
327725|NCT00285649|O1|Outcome|HVLA-SM|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
327726|NCT00285649|E3|Reported Event|Usual Medical Care*|"Usual Medical Care, Active Comparator, advice, exercises and medications
Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
327727|NCT00285649|E2|Reported Event|LVVA-SM*|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
327728|NCT00285649|E1|Reported Event|HVLA-SM*|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
327729|NCT00293709|B1|Baseline|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327730|NCT00293709|P1|Participant Flow|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327766|NCT00293813|O1|Outcome|Alendronate 70 mg QW|Alendronate 70 mg QW
327731|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327732|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327733|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327734|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327735|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327736|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327737|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327738|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327739|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327740|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327741|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327742|NCT00293709|E1|Reported Event|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
328053|NCT00295009|P2|Participant Flow|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
327743|NCT00293722|B1|Baseline|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327744|NCT00293722|P1|Participant Flow|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327745|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327746|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327747|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327748|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327749|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327750|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327751|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327752|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327753|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327754|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327755|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327756|NCT00293722|E1|Reported Event|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
327757|NCT00293813|B4|Baseline|Total|Total of all reporting groups
327758|NCT00293813|B3|Baseline|Placebo|Placebo
327759|NCT00293813|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
327760|NCT00293813|B1|Baseline|Alendronate 70 mg QW|Alendronate 70 mg QW
327774|NCT00294398|B2|Baseline|ICS Prescription + Standard ED Discharge Therapy|"Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age:
1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
327775|NCT00294398|B1|Baseline|Standard Asthma ED Discharge Therapy|Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and are provided a home nebulizer if needed.
327776|NCT00294398|P2|Participant Flow|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age:
1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
327777|NCT00294398|P1|Participant Flow|Standard Asthma ED Discharge Therapy|Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and were provided a home nebulizer if needed.
327778|NCT00294398|O2|Outcome|ICS Prescription + Standard Asthma ED Discharge Therapy:|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:
1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
327779|NCT00294398|O1|Outcome|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
328631|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
327780|NCT00294398|O2|Outcome|ICS Prescription + Standard Asthma ED Discharge Therapy:|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:
1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
327781|NCT00294398|O1|Outcome|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
327782|NCT00294398|E2|Reported Event|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:
1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
327783|NCT00294398|E1|Reported Event|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
327784|NCT00294515|B3|Baseline|Total|Total of all reporting groups
327785|NCT00294515|B2|Baseline|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
327786|NCT00294515|B1|Baseline|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
327787|NCT00294515|P2|Participant Flow|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
327788|NCT00294515|P1|Participant Flow|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
327789|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
327790|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
327791|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
327792|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
327793|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
327794|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
327795|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
327796|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
327797|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
327798|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
327799|NCT00294515|E2|Reported Event|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
327800|NCT00294515|E1|Reported Event|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
327801|NCT00294645|B3|Baseline|Total|Total of all reporting groups
327802|NCT00294645|B2|Baseline|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327803|NCT00294645|B1|Baseline|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327804|NCT00294645|P2|Participant Flow|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327805|NCT00294645|P1|Participant Flow|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327806|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327807|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327808|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327809|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327810|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
328082|NCT00295490|B5|Baseline|Total|Total of all reporting groups
327812|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327813|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327814|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327815|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327816|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327817|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327818|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327819|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327820|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327821|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327822|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327823|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327824|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327825|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327826|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327827|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327828|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327829|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327830|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327831|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327832|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327833|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327834|NCT00294645|E2|Reported Event|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
327835|NCT00294645|E1|Reported Event|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
327836|NCT00294658|B3|Baseline|Total|Total of all reporting groups
327837|NCT00294658|B2|Baseline|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327838|NCT00294658|B1|Baseline|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327839|NCT00294658|P2|Participant Flow|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen had been taken every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327840|NCT00294658|P1|Participant Flow|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy had been performed as soon as possible after randomization."
327841|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327842|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327843|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327844|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327845|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327846|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327847|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327848|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327849|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327850|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327851|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327852|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327853|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327854|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327855|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327856|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327857|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327858|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327859|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327860|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327861|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
328054|NCT00295009|P1|Participant Flow|1-Level Fusion|Circumferential fusion at a single lumbar level.
328632|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
327862|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327863|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327864|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327865|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327866|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327867|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327868|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327869|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327870|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327871|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327872|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327873|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327874|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327875|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327876|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327877|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327878|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327879|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327880|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327881|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327882|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327883|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327884|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
328369|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
327885|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327886|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327887|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327888|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327889|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327890|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327891|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327892|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327893|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327894|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
328633|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
327895|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327896|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327897|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327898|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327899|NCT00294658|E2|Reported Event|Prednisone Alone|"Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
327900|NCT00294658|E1|Reported Event|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization."
327901|NCT00294671|B3|Baseline|Total|Total of all reporting groups
327902|NCT00294671|B2|Baseline|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
327903|NCT00294671|B1|Baseline|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
327904|NCT00294671|P2|Participant Flow|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
327905|NCT00294671|P1|Participant Flow|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
327906|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
327907|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
327908|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
327909|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
327910|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
327911|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
327912|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
327913|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
327914|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
327915|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
327916|NCT00294671|E2|Reported Event|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
327917|NCT00294671|E1|Reported Event|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
327918|NCT00294684|B3|Baseline|Total|Total of all reporting groups
327919|NCT00294684|B2|Baseline|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327920|NCT00294684|B1|Baseline|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
328237|NCT00296036|O3|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I.
327921|NCT00294684|P2|Participant Flow|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327922|NCT00294684|P1|Participant Flow|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327923|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327976|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
328265|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
327924|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327925|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327926|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327927|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327928|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327929|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327930|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
328243|NCT00296036|O3|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I
327931|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327932|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327933|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327977|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327978|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
328634|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
327934|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327935|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327936|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327937|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327938|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327939|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327940|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327941|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327942|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327943|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327979|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
327980|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
328635|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
327944|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327945|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327946|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327947|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327948|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327949|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327950|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327951|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327952|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327953|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327981|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327982|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
328636|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
327954|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327955|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327956|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327957|NCT00294684|E2|Reported Event|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
327958|NCT00294684|E1|Reported Event|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
327959|NCT00294723|B4|Baseline|Total|Total of all reporting groups
327960|NCT00294723|B3|Baseline|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327961|NCT00294723|B2|Baseline|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
327962|NCT00294723|B1|Baseline|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327963|NCT00294723|P3|Participant Flow|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327964|NCT00294723|P2|Participant Flow|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
327965|NCT00294723|P1|Participant Flow|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327966|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327967|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
327968|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327969|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327970|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
327971|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327972|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327973|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
327974|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327975|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327983|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327984|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327985|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
327986|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327987|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327988|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
327989|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327990|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327991|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
327992|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327993|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327994|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
327995|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327996|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
327997|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
327998|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
327999|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
328000|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
328001|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
328370|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328002|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
328003|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
328004|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
328005|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
328006|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
328007|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
328008|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
328009|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
328010|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
328011|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
328012|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
328637|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328013|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
328014|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
328015|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
328016|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
328017|NCT00294723|E6|Reported Event|Glimepiride (Weeks 104-195)|Open-label glimepiride 8 mg once daily in the additional extension period (weeks 104-195)
328018|NCT00294723|E5|Reported Event|Lira 1.2 (Weeks 104-195)|Open-label liraglutide 1.2 mg once daily in the additional extension period (weeks 104-195)
328019|NCT00294723|E4|Reported Event|Lira 1.8 (Weeks 104-195)|Open-label liraglutide 1.8 mg once daily in the additional extension period (weeks 104-195)
328020|NCT00294723|E3|Reported Event|Glimepiride (Weeks 0-104)|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension period (weeks 52-104)
328021|NCT00294723|E2|Reported Event|Lira 1.2 (Weeks 0-104)|Liraglutide 1.2 mg once daily + glimepiride placebo 8mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension period (weeks 52-104)
328022|NCT00294723|E1|Reported Event|Lira 1.8 (Weeks 0-104)|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension period (weeks 52-104)
328023|NCT00294762|B3|Baseline|Total|Total of all reporting groups
328024|NCT00294762|B2|Baseline|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
328025|NCT00294762|B1|Baseline|Erlotinib|150 mg erlotinib daily
328026|NCT00294762|P2|Participant Flow|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
328027|NCT00294762|P1|Participant Flow|Erlotinib|150 mg erlotinib daily
328028|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
328029|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
328030|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
328031|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
328032|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
328033|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
328034|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
328035|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
328036|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
328037|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
328038|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
328039|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
328040|NCT00294762|E2|Reported Event|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
328041|NCT00294762|E1|Reported Event|Erlotinib|150 mg erlotinib daily
328042|NCT00295009|B7|Baseline|Total|Total of all reporting groups
328043|NCT00295009|B6|Baseline|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
328044|NCT00295009|B5|Baseline|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
328045|NCT00295009|B4|Baseline|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
328046|NCT00295009|B3|Baseline|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
328047|NCT00295009|B2|Baseline|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
328048|NCT00295009|B1|Baseline|1-Level Fusion|Circumferential fusion at a single lumbar level.
328049|NCT00295009|P6|Participant Flow|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
328050|NCT00295009|P5|Participant Flow|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
328051|NCT00295009|P4|Participant Flow|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
328052|NCT00295009|P3|Participant Flow|1-Level ProDisc (Non-Randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
328055|NCT00295009|O6|Outcome|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
328056|NCT00295009|O5|Outcome|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
328057|NCT00295009|O4|Outcome|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
328058|NCT00295009|O3|Outcome|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
328059|NCT00295009|O2|Outcome|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
328060|NCT00295009|O1|Outcome|1-Level Fusion|Circumferential fusion at a single lumbar level.
328061|NCT00295009|O6|Outcome|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
328062|NCT00295009|O5|Outcome|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
328063|NCT00295009|O4|Outcome|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
328064|NCT00295009|O3|Outcome|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
328065|NCT00295009|O2|Outcome|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
328066|NCT00295009|O1|Outcome|1-Level Fusion|Circumferential fusion at a single lumbar level.
328067|NCT00295009|E6|Reported Event|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
328068|NCT00295009|E5|Reported Event|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
328069|NCT00295009|E4|Reported Event|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
328070|NCT00295009|E3|Reported Event|1-Level ProDisc (Non-Randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
328071|NCT00295009|E2|Reported Event|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
328072|NCT00295009|E1|Reported Event|1-Level Fusion|Circumferential fusion at a single lumbar level.
328073|NCT00295061|B3|Baseline|Total|Total of all reporting groups
328074|NCT00295061|B2|Baseline|Prolastin / Alpha-1 MP|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
328075|NCT00295061|B1|Baseline|Alpha-1 MP / Prolastin|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
328076|NCT00295061|P2|Participant Flow|Prolastin / Alpha-1 MP|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
328077|NCT00295061|P1|Participant Flow|Alpha-1 MP / Prolastin|Sequential, blinded treatment periods of Alpha-1 modified process (MP) (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
328078|NCT00295061|O2|Outcome|Prolastin|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
328079|NCT00295061|O1|Outcome|Alpha-1 MP|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
328080|NCT00295061|E2|Reported Event|Prolastin|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
328081|NCT00295061|E1|Reported Event|Alpha-1 MP|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
328083|NCT00295490|B4|Baseline|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
328084|NCT00295490|B3|Baseline|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
328085|NCT00295490|B2|Baseline|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
328086|NCT00295490|B1|Baseline|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
328087|NCT00295490|P4|Participant Flow|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
328088|NCT00295490|P3|Participant Flow|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
328089|NCT00295490|P2|Participant Flow|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
328090|NCT00295490|P1|Participant Flow|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
328266|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
328091|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
328092|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
328093|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
328094|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
328095|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
328096|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
328097|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
328098|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
328099|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
328100|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
328101|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
328102|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
328103|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
328104|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
328301|NCT00296244|P2|Participant Flow|Study Group|Study group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)
328105|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
328106|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
328107|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
328108|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
328109|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
328110|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
328111|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
328112|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
328170|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328392|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328113|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
328114|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
328115|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
328116|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
328117|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
328118|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
328119|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
328120|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
328121|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
328122|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
328123|NCT00295490|E4|Reported Event|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
328124|NCT00295490|E3|Reported Event|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
328125|NCT00295490|E2|Reported Event|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
328238|NCT00296036|O2|Outcome|Arm II: (Urea/Lactic Acid + Placebo)|Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
328126|NCT00295490|E1|Reported Event|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
328127|NCT00295503|B1|Baseline|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg IV every 3 weeks
328128|NCT00295503|P1|Participant Flow|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
328129|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
328130|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed, Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
328131|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed, Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
328132|NCT00295503|E1|Reported Event|Experimental Arm|cisplatin, pemetrexed, and bevacizumab
328133|NCT00295633|B4|Baseline|Total|Total of all reporting groups
328134|NCT00295633|B3|Baseline|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328135|NCT00295633|B2|Baseline|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328136|NCT00295633|B1|Baseline|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328137|NCT00295633|P3|Participant Flow|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328138|NCT00295633|P2|Participant Flow|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328393|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328139|NCT00295633|P1|Participant Flow|Saxagliptin 2.5 mg Plus Open-label Thiazolidinedione (TZD)|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328140|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328141|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328142|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328143|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328144|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328145|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328146|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328147|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328148|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328149|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328150|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328239|NCT00296036|O1|Outcome|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
328151|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
328152|NCT00295633|E3|Reported Event|SAXA 5MG + TZD|
328153|NCT00295633|E2|Reported Event|SAXA 2.5MG + TZD|
328154|NCT00295633|E1|Reported Event|PLA + TZD|
328155|NCT00295750|B4|Baseline|Total|Total of all reporting groups
328156|NCT00295750|B3|Baseline|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328157|NCT00295750|B2|Baseline|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328158|NCT00295750|B1|Baseline|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328159|NCT00295750|P3|Participant Flow|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328160|NCT00295750|P2|Participant Flow|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328161|NCT00295750|P1|Participant Flow|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328162|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328163|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328164|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328165|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328166|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328167|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328168|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328169|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328171|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328172|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328173|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328174|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328175|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328176|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328177|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328178|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328179|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328180|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328181|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328182|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328183|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328184|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328185|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328186|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328187|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328188|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328189|NCT00295750|E3|Reported Event|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
328190|NCT00295750|E2|Reported Event|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
328191|NCT00295750|E1|Reported Event|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
328192|NCT00295854|B4|Baseline|Total|Total of all reporting groups
328240|NCT00296036|O6|Outcome|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
328193|NCT00295854|B3|Baseline|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328194|NCT00295854|B2|Baseline|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328195|NCT00295854|B1|Baseline|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328196|NCT00295854|P3|Participant Flow|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328197|NCT00295854|P2|Participant Flow|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328198|NCT00295854|P1|Participant Flow|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328199|NCT00295854|O3|Outcome|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328200|NCT00295854|O2|Outcome|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328201|NCT00295854|O1|Outcome|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328202|NCT00295854|O3|Outcome|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328203|NCT00295854|O2|Outcome|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328204|NCT00295854|O1|Outcome|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328241|NCT00296036|O5|Outcome|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
328242|NCT00296036|O4|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream and oral placebo.
328205|NCT00295854|E3|Reported Event|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328206|NCT00295854|E2|Reported Event|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328207|NCT00295854|E1|Reported Event|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
328208|NCT00295880|B1|Baseline|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
328209|NCT00295880|P1|Participant Flow|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
328210|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
328211|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
328212|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
328213|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
328214|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
328215|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
328216|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
328217|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
328264|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
328967|NCT00296647|B3|Baseline|Bupropion|
328218|NCT00295880|E1|Reported Event|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
328219|NCT00296036|B3|Baseline|Total|Total of all reporting groups
328220|NCT00296036|B2|Baseline|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
328221|NCT00296036|B1|Baseline|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
328222|NCT00296036|P6|Participant Flow|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
328223|NCT00296036|P5|Participant Flow|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
328224|NCT00296036|P4|Participant Flow|Arm IV: (Placebo + Placebo)|Patients receive placebo cream and oral placebo.
328225|NCT00296036|P3|Participant Flow|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I
328226|NCT00296036|P2|Participant Flow|Arm II: (Urea/Lactic Acid + Placebo)|Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
328227|NCT00296036|P1|Participant Flow|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
328228|NCT00296036|O6|Outcome|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
328229|NCT00296036|O5|Outcome|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
328230|NCT00296036|O4|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007).
328231|NCT00296036|O3|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007).
328232|NCT00296036|O2|Outcome|Arm II: (Urea/Lactic Acid + Placebo)|"Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
urea/lactic acid-based topical cream: Applied topically
placebo: Given orally or applied topically"
328233|NCT00296036|O1|Outcome|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
328234|NCT00296036|O6|Outcome|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
328235|NCT00296036|O5|Outcome|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
328236|NCT00296036|O4|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream as in arm III and oral placebo as in arm II.
328360|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328244|NCT00296036|O2|Outcome|Arm II: (Urea/Lactic Acid + Placebo)|Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
328245|NCT00296036|O1|Outcome|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
328246|NCT00296036|O2|Outcome|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily.
328247|NCT00296036|O1|Outcome|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.
328248|NCT00296036|O2|Outcome|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily.
328249|NCT00296036|O1|Outcome|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.
328250|NCT00296036|E2|Reported Event|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
328251|NCT00296036|E1|Reported Event|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
328252|NCT00296192|B6|Baseline|Total|Total of all reporting groups
328253|NCT00296192|B5|Baseline|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
328254|NCT00296192|B4|Baseline|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
328255|NCT00296192|B3|Baseline|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
328256|NCT00296192|B2|Baseline|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
328257|NCT00296192|B1|Baseline|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
328258|NCT00296192|P5|Participant Flow|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
328259|NCT00296192|P4|Participant Flow|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
328260|NCT00296192|P3|Participant Flow|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
328261|NCT00296192|P2|Participant Flow|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
328262|NCT00296192|P1|Participant Flow|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
328263|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
328394|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328267|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
328268|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
328269|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
328270|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
328271|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
328272|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
328273|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
328274|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
328275|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
328276|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
328277|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
328278|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
328279|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
328280|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
328281|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
328282|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
328283|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
328284|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
328285|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
328286|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
328287|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
328288|NCT00296192|E5|Reported Event|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
328289|NCT00296192|E4|Reported Event|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
328290|NCT00296192|E3|Reported Event|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
328291|NCT00296192|E2|Reported Event|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
328292|NCT00296192|E1|Reported Event|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
328293|NCT00296231|B1|Baseline|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
328294|NCT00296231|P1|Participant Flow|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
328295|NCT00296231|O1|Outcome|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
328296|NCT00296231|O1|Outcome|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
328297|NCT00296231|E1|Reported Event|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
328298|NCT00296244|B3|Baseline|Total|Total of all reporting groups
328299|NCT00296244|B2|Baseline|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
328300|NCT00296244|B1|Baseline|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
328361|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328302|NCT00296244|P1|Participant Flow|Control Group|Control group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)with steroids
328303|NCT00296244|O2|Outcome|Study Group|Study group - basiliximab, tacrolimus, EC-MPA
328304|NCT00296244|O1|Outcome|Control Group|Control group- basiliximab, tacrolimus, EC-MPA, steroids
328305|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
328306|NCT00296244|O1|Outcome|Control Group|Control group)-basiliximab, tacrolimus, EC-MPA, steroids
328307|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
328308|NCT00296244|O1|Outcome|Control Group|Control group)-basiliximab, tacrolimus, EC-MPA, steroids
328309|NCT00296244|O2|Outcome|Study Group|Study group -basiliximab, tacrolimus, EC-MPA
328310|NCT00296244|O1|Outcome|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
328311|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
328312|NCT00296244|O1|Outcome|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
328313|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
328314|NCT00296244|O1|Outcome|Control Group|Control group-basiliximab, tacrolimus, EC-MPA, steroids
328315|NCT00296244|E2|Reported Event|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
328316|NCT00296244|E1|Reported Event|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
328317|NCT00296322|B3|Baseline|Total|Total of all reporting groups
328318|NCT00296322|B2|Baseline|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
328319|NCT00296322|B1|Baseline|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
328320|NCT00296322|P2|Participant Flow|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
328321|NCT00296322|P1|Participant Flow|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
328322|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
328323|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
328324|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
328325|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
328326|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
328327|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
328328|NCT00296322|E2|Reported Event|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
328329|NCT00296322|E1|Reported Event|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
328330|NCT00296335|B3|Baseline|Total|Total of all reporting groups
328331|NCT00296335|B2|Baseline|Mitomycin, Doxifluridine and Cisplatin|Experimental armMitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
328332|NCT00296335|B1|Baseline|Mitomycin and Doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
328333|NCT00296335|P2|Participant Flow|Mitomycin, Doxifluridine and Cisplatin|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
328334|NCT00296335|P1|Participant Flow|Mitomycin and Doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
328335|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
328336|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
328337|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
328338|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
328339|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
328340|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
328341|NCT00296335|E2|Reported Event|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
328342|NCT00296335|E1|Reported Event|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
328343|NCT00296374|B4|Baseline|Total|Total of all reporting groups
328344|NCT00296374|B3|Baseline|Atorvastatin 80mg|
328345|NCT00296374|B2|Baseline|Rosuvastatin 40mg|
328346|NCT00296374|B1|Baseline|Rosuvastatin 10mg|
328347|NCT00296374|P3|Participant Flow|Atorvastatin 80mg|
328348|NCT00296374|P2|Participant Flow|Rosuvastatin 40mg|
328349|NCT00296374|P1|Participant Flow|Rosuvastatin 10mg|
328350|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328351|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328352|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328353|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328354|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328355|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328356|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328357|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328358|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328359|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328371|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328372|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328373|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328374|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328375|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328376|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328377|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328378|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328379|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328380|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328381|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328382|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328383|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328384|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328385|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328386|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328387|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328388|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328389|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
328390|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328391|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328638|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328639|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328640|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328641|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328642|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328643|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328644|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328645|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328646|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328647|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328648|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328649|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328650|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328651|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328652|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328653|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328654|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328655|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328656|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328657|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328658|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328659|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328660|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328661|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328662|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328663|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328664|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328665|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328666|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328667|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328668|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328669|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328670|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328671|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328672|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328673|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328674|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328675|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328676|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328677|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328678|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328679|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328680|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328681|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328682|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328683|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328684|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328685|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328686|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328687|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328688|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328689|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328690|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328691|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328692|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328693|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328694|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328695|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328696|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328697|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328698|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328699|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328700|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328701|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328702|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328703|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328704|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328705|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328706|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328707|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328708|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328709|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328710|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328711|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328712|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328713|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328714|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328715|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328716|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328717|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328718|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328719|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328720|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328721|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328722|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328723|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328724|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328725|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328726|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328727|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328728|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328729|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328730|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328731|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328732|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328733|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328734|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328735|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328736|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328737|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328738|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328739|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328740|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328741|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328742|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328743|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328744|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328745|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328746|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328747|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328748|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328749|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328750|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328751|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328752|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328753|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328754|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328755|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328756|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328757|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328758|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328759|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328760|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328761|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328762|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328763|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328764|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328765|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328766|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328767|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328768|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328769|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328770|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328771|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
328772|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
328773|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
328774|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
328775|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
328776|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
328777|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
328778|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
328779|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
328780|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
328781|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
328782|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
328783|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
328784|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
328785|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
328786|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
328787|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
328788|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
328789|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
328790|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
328791|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
328792|NCT00296400|E3|Reported Event|Atorvastatin 80 mg|
328793|NCT00296400|E2|Reported Event|Rosuvastatin 40 mg|
328794|NCT00296400|E1|Reported Event|Rosuvastatin 10 mg|
328795|NCT00296491|B5|Baseline|Total|Total of all reporting groups
328796|NCT00296491|B4|Baseline|Montelukast (MON)|Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
328797|NCT00296491|B3|Baseline|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
328798|NCT00296491|B2|Baseline|Fluticasone Propionate/Salmeterol (FSC)|Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
328799|NCT00296491|B1|Baseline|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
328800|NCT00296491|P4|Participant Flow|Montelukast (MON)|
328801|NCT00296491|P3|Participant Flow|Fluticasone Propionate/Salmeterol (FSC)|
328802|NCT00296491|P2|Participant Flow|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
328803|NCT00296491|P1|Participant Flow|Flut Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Flut Prop = Fluticasone Propionate.
328804|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
328805|NCT00296491|O1|Outcome|Fluticasone Propionate + Salmeterol & Montelukast (FSC+MON)|
328806|NCT00296491|O2|Outcome|Montelukast (MON)|
328807|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
328808|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
328809|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
328810|NCT00296491|O2|Outcome|Montelukast (MON)|
328811|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
328812|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
328813|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
328814|NCT00296491|O2|Outcome|Montelukast (MON)|
328815|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
328816|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
328817|NCT00296491|O1|Outcome|Flut Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)|
328818|NCT00296491|O2|Outcome|Fluticasone Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)|
328819|NCT00296491|O1|Outcome|Fluticasone Prop/Salmeterol/Montelukast (FSC+MON)|
328820|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
328821|NCT00296491|O1|Outcome|Flut Prop/Salmeterol/Montelukast (FSC+MON)|
328822|NCT00296491|O2|Outcome|Montelukast (MON)|
328823|NCT00296491|O1|Outcome|Fluticasone Prop/Salmeterol (FSC)|
328824|NCT00296491|E4|Reported Event|Montelukast (MON)|Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
328825|NCT00296491|E3|Reported Event|Fluticasone Propionate/Salmeterol (FSC)|Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
328826|NCT00296491|E2|Reported Event|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
328827|NCT00296491|E1|Reported Event|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
328828|NCT00296504|B9|Baseline|Total|Total of all reporting groups
328829|NCT00296504|B8|Baseline|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328830|NCT00296504|B7|Baseline|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328831|NCT00296504|B6|Baseline|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328832|NCT00296504|B5|Baseline|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328833|NCT00296504|B4|Baseline|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328834|NCT00296504|B3|Baseline|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
328835|NCT00296504|B2|Baseline|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
328836|NCT00296504|B1|Baseline|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
328837|NCT00296504|P9|Participant Flow|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
328838|NCT00296504|P8|Participant Flow|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328839|NCT00296504|P7|Participant Flow|Protease Inhibitor (PI)-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328840|NCT00296504|P6|Participant Flow|FPV/RTV Twice Daily (BID) Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328841|NCT00296504|P5|Participant Flow|FPV/RTV Once Daily (QD) Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328842|NCT00296504|P4|Participant Flow|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328843|NCT00296504|P3|Participant Flow|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
328844|NCT00296504|P2|Participant Flow|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received nelfinavir (NFV) in APV30001
330352|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
328845|NCT00296504|P1|Participant Flow|FPV Population (APV30001)|Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554)
328846|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328847|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328848|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328849|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328850|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328851|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
328852|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
328853|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
328854|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328855|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328856|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328857|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328858|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328859|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
328860|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
328861|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
328862|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
328863|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328864|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328865|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328866|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328867|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328868|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
328869|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
328870|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
328871|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328872|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FFPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328873|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328874|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328875|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328876|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
328877|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
328878|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
328879|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
328880|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328881|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328882|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328883|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328884|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328885|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
328886|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
328887|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
329010|NCT00288600|E1|Reported Event|Experimental Group|"Intravenous Immunoglobulin
Intravenous Immunoglobulin: Intravenous Immunoglobulin"
328888|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
328889|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328890|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328891|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328892|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328893|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328894|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
328895|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
328896|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
328897|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
328898|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328899|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328900|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328901|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328902|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328903|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
328904|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
328905|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
328906|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
328907|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328908|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328909|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328910|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328911|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328912|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
328913|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
328914|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
328915|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
328916|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328917|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328918|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328919|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328920|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328921|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
328922|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
328923|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
328924|NCT00296504|E9|Reported Event|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
328925|NCT00296504|E8|Reported Event|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
328926|NCT00296504|E7|Reported Event|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
328927|NCT00296504|E6|Reported Event|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
328928|NCT00296504|E5|Reported Event|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
328929|NCT00296504|E4|Reported Event|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
328930|NCT00296504|E3|Reported Event|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
330353|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
328931|NCT00296504|E2|Reported Event|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
328932|NCT00296504|E1|Reported Event|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
328933|NCT00296517|B3|Baseline|Total|Total of all reporting groups
328934|NCT00296517|B2|Baseline|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328935|NCT00296517|B1|Baseline|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328936|NCT00296517|P2|Participant Flow|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328937|NCT00296517|P1|Participant Flow|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328938|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328968|NCT00296647|B2|Baseline|Nicotine Lozenge|
328969|NCT00296647|B1|Baseline|Patch|
328939|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328940|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328941|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328942|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328943|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328944|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328945|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328946|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328947|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328948|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328949|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328950|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328951|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328952|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328953|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328954|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328955|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328956|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328957|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328958|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328959|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328960|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328961|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328962|NCT00296517|E2|Reported Event|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
328963|NCT00296517|E1|Reported Event|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
328964|NCT00296647|B6|Baseline|Total|Total of all reporting groups
328965|NCT00296647|B5|Baseline|Buproion + Lozenge|
328966|NCT00296647|B4|Baseline|Patch + Lozenge|
328970|NCT00296647|P5|Participant Flow|Buproion + Lozenge|
328971|NCT00296647|P4|Participant Flow|Patch + Lozenge|
328972|NCT00296647|P3|Participant Flow|Bupropion|
328973|NCT00296647|P2|Participant Flow|Nicotine Lozenge|
328974|NCT00296647|P1|Participant Flow|Patch|
328975|NCT00296647|O5|Outcome|Buproion + Lozenge|
328976|NCT00296647|O4|Outcome|Patch + Lozenge|
328977|NCT00296647|O3|Outcome|Bupropion|
328978|NCT00296647|O2|Outcome|Lozenge|
328979|NCT00296647|O1|Outcome|Patch|
328980|NCT00296647|E5|Reported Event|Buproion + Lozenge|
328981|NCT00296647|E4|Reported Event|Patch + Lozenge|
328982|NCT00296647|E3|Reported Event|Bupropion|
328983|NCT00296647|E2|Reported Event|Nicotine Lozenge|
328984|NCT00296647|E1|Reported Event|Patch|
328985|NCT00288587|B3|Baseline|Total|Total of all reporting groups
328986|NCT00288587|B2|Baseline|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
328987|NCT00288587|B1|Baseline|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
328988|NCT00288587|P2|Participant Flow|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
328989|NCT00288587|P1|Participant Flow|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
328990|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
328991|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
328992|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
328993|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
328994|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
328995|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
328996|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
328997|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
328998|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
328999|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
329000|NCT00288587|E2|Reported Event|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
329001|NCT00288587|E1|Reported Event|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
329002|NCT00288600|B3|Baseline|Total|Total of all reporting groups
329003|NCT00288600|B2|Baseline|Control Group- Normal Saline|"Normal Saline solution and Phototherapy
Normal saline solution: Normal saline solution 10 ml/Kg"
329004|NCT00288600|B1|Baseline|Experimental Group - Immunoglobulin|"Intravenous Immunoglobulin and Phototherapy
Intravenous Immunoglobulin: Intravenous Immunoglobulin"
329005|NCT00288600|P2|Participant Flow|Control Group|"Normal Saline solution
Normal saline solution: Normal saline solution 10 ml/Kg"
329006|NCT00288600|P1|Participant Flow|Experimental Group|"Intravenous Immunoglobulin
Intravenous Immunoglobulin: Intravenous Immunoglobulin"
329007|NCT00288600|O2|Outcome|Control Group|"Normal Saline solution
Normal saline solution: Normal saline solution 10 ml/Kg"
329008|NCT00288600|O1|Outcome|Experimental Group|"Intravenous Immunoglobulin
Intravenous Immunoglobulin: Intravenous Immunoglobulin"
329009|NCT00288600|E2|Reported Event|Control Group|"Normal Saline solution
Normal saline solution: Normal saline solution 10 ml/Kg"
329011|NCT00288626|B1|Baseline|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329012|NCT00288626|P1|Participant Flow|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥ 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329013|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329014|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329015|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329016|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329017|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329047|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329018|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329019|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329035|NCT00288639|P1|Participant Flow|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329020|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329021|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329022|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329023|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329024|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329025|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329026|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329036|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
330389|NCT00301262|O1|Outcome|DB Viagra Week 8|
329027|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329028|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329029|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329030|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥ 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329031|NCT00288626|O1|Outcome|HDIT and HCT|Participants received Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329032|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329033|NCT00288626|E1|Reported Event|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until > 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
329034|NCT00288639|B1|Baseline|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329037|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329038|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329039|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329040|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329041|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329042|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329043|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329044|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329045|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329046|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
330354|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
329048|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329049|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329050|NCT00288639|E1|Reported Event|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
329051|NCT00288704|B4|Baseline|Total|Total of all reporting groups
329052|NCT00288704|B3|Baseline|Open-Label Rilonacept 160 mg|57 new subjects entered the study directly into the OLE. This was not part of the double blind or randomized withdrawal portion of the results. The 44 subjects who completed Parts A and B were not included in this category for baseline characteristics. Pediatric subjects , age 7 or older, received rilonacept dosed 2.2 mg/kg weekly up to 160 mg during the OLE.
329053|NCT00288704|B2|Baseline|Rilonacept 160 mg|
329054|NCT00288704|B1|Baseline|Placebo|
329055|NCT00288704|P3|Participant Flow|Open-Label Extension (OLE) Rilonacept 160 mg|"After week 24 of study, all subjects received weekly injections of rilonacept 160 mg until the end of the study. This was not part of the double blind (Part A) or randomized withdrawal (Part B) portion of the results. Pediatric subjects received rilonacept dosed 2.2 mg/kg weekly up to 160 mg.
Study drug is administered as a 2.0 mL subcutaneous injection once a week."
329056|NCT00288704|P2|Participant Flow|Rilonacept 160 mg|"If assigned, subjects received rilonacept 160 mg during 1) the first 6 weeks of the study (Part A) or 2) during the randomized withdrawal period from weeks 15-24 (Part B). Note: Between weeks 6 and 15 (Parts A and B), all subjects received rilonacept 160 mg.
Study drug is administered as a 2.0 mL subcutaneous injection once a week. At baseline (week 0) subjects receive a loading dose of rilonacept 320 mg."
329057|NCT00288704|P1|Participant Flow|Placebo|If assigned, subjects received Placebo during 1) the first 6 weeks of the study (Part A) or 2) during the randomized withdrawal period from weeks 15-24 (Part B). No subject received Placebo during the open-label extension (after week 24). The drug is administered subcutaneously on a weekly basis.
329058|NCT00288704|O1|Outcome|Rilonacept 160 mg|
329059|NCT00288704|O1|Outcome|Rilonacept 160 mg|
329060|NCT00288704|O1|Outcome|Rilonacept 160 mg|
329061|NCT00288704|O2|Outcome|Rilonacept 160 mg|
329062|NCT00288704|O1|Outcome|Placebo|
329063|NCT00288704|O2|Outcome|Rilonacept 160 mg|
329064|NCT00288704|O1|Outcome|Placebo|
329065|NCT00288704|O2|Outcome|Rilonacept 160 mg|
329066|NCT00288704|O1|Outcome|Placebo|
329067|NCT00288704|O2|Outcome|Rilonacept 160 mg|
329068|NCT00288704|O1|Outcome|Placebo|
329069|NCT00288704|O2|Outcome|Rilonacept 160 mg|
329070|NCT00288704|O1|Outcome|Placebo|
329071|NCT00288704|O2|Outcome|Rilonacept 160 mg|
329072|NCT00288704|O1|Outcome|Placebo|
329073|NCT00288704|O2|Outcome|Rilonacept 160 mg|
329074|NCT00288704|O1|Outcome|Placebo|
329075|NCT00288704|O2|Outcome|Rilonacept 160 mg|
329076|NCT00288704|O1|Outcome|Placebo|
329077|NCT00288704|O2|Outcome|Rilonacept 160 mg|
329078|NCT00288704|O1|Outcome|Placebo|
329079|NCT00288704|O2|Outcome|Rilonacept 160 mg|
329080|NCT00288704|O1|Outcome|Placebo|
329081|NCT00288704|E2|Reported Event|Placebo|
329082|NCT00288704|E1|Reported Event|Rilonacept 160 mg|
329083|NCT00288860|B3|Baseline|Total|Total of all reporting groups
329084|NCT00288860|B2|Baseline|Treatment-As-Usual|"Treatment as usual
Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
329085|NCT00288860|B1|Baseline|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual
Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
329086|NCT00288860|P2|Participant Flow|Treatment-As-Usual|"Treatment as usual
Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
329087|NCT00288860|P1|Participant Flow|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual
Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
329088|NCT00288860|O2|Outcome|Treatment-As-Usual|"Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.
TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)"
329089|NCT00288860|O1|Outcome|Telephone Monitoring|"Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.
Telephone monitoring: Three months of biweekly telephone monitoring and support
TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)"
329090|NCT00288860|O2|Outcome|Treatment-As-Usual|"Treatment as usual
Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
329091|NCT00288860|O1|Outcome|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual
Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
329092|NCT00288860|O2|Outcome|Treatment as Usual|"Treatment as usual
Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
329394|NCT00289536|E1|Reported Event|Safety Population (26 Participants)|Participants who received at least 1 infusion of rAHF-PFM
329093|NCT00288860|O1|Outcome|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual
Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
329094|NCT00288860|E2|Reported Event|Treatment-As-Usual|"Treatment as usual
Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
329095|NCT00288860|E1|Reported Event|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual
Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
329096|NCT00288886|B3|Baseline|Total|Total of all reporting groups
329097|NCT00288886|B2|Baseline|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance
CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.
Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.
Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).
Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
329122|NCT00288912|P2|Participant Flow|Arm 2|Usual Medical Care
329123|NCT00288912|P1|Participant Flow|Arm 1|"Health Education Intervention
Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
329098|NCT00288886|B1|Baseline|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.
An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
329099|NCT00288886|P2|Participant Flow|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance
CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.
Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.
Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).
Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
329100|NCT00288886|P1|Participant Flow|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.
An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
329101|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance
CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.
Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.
Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).
Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
329102|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.
An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
329103|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance
CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.
Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.
Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).
Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
329104|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.
An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
329164|NCT00289107|E2|Reported Event|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
329165|NCT00289107|E1|Reported Event|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
329105|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance
CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.
Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.
Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).
Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
329106|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.
An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
329107|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance
CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.
Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.
Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).
Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
329179|NCT00289120|O1|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
329760|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329108|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.
An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
329109|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance
CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.
Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.
Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).
Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
329110|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.
An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
329111|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance
CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.
Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.
Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).
Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
329112|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.
An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
329113|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance
CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.
Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.
Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).
Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
329114|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.
An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
329115|NCT00288886|E2|Reported Event|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance
CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.
Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.
Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).
Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
329116|NCT00288886|E1|Reported Event|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.
An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
329117|NCT00288912|B4|Baseline|Total|Total of all reporting groups
329118|NCT00288912|B3|Baseline|Arm 3|"Osteoarthritis Self-Management
Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
329119|NCT00288912|B2|Baseline|Arm 2|Usual Medical Care
329120|NCT00288912|B1|Baseline|Arm 1|"Health Education Intervention
Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
329121|NCT00288912|P3|Participant Flow|Arm 3|"Osteoarthritis Self-Management
Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
329124|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management
Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
329125|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
329126|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention
Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
329127|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management
Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
329128|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
329129|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention
Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
329130|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management
Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
329131|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
329132|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention
Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
329133|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management
Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
329134|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
329135|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention
Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
329136|NCT00288912|E3|Reported Event|Arm 3|"Osteoarthritis Self-Management
Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
329137|NCT00288912|E2|Reported Event|Arm 2|Usual Medical Care
329138|NCT00288912|E1|Reported Event|Arm 1|"Health Education Intervention
Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
329139|NCT00289016|B1|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
329140|NCT00289016|P1|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
329631|NCT00289848|B3|Baseline|Total|Total of all reporting groups
329141|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
329142|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
329143|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
329144|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
329145|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
329342|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
329146|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
329147|NCT00289016|E1|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
329148|NCT00289094|B3|Baseline|Total|Total of all reporting groups
329149|NCT00289094|B2|Baseline|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
329150|NCT00289094|B1|Baseline|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
329151|NCT00289094|P2|Participant Flow|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
329152|NCT00289094|P1|Participant Flow|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
329153|NCT00289094|O2|Outcome|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
329154|NCT00289094|O1|Outcome|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
329155|NCT00289094|E2|Reported Event|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
329156|NCT00289094|E1|Reported Event|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
329157|NCT00289107|B3|Baseline|Total|Total of all reporting groups
329158|NCT00289107|B2|Baseline|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
329159|NCT00289107|B1|Baseline|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
329160|NCT00289107|P2|Participant Flow|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
329161|NCT00289107|P1|Participant Flow|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
329162|NCT00289107|O2|Outcome|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
329163|NCT00289107|O1|Outcome|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
329698|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329166|NCT00289120|B1|Baseline|Cola First, Then Water|"Phase 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.
There will be a 3-week wash out period before subjects enter phase 2 of the study.
Phase 2: Subjects will be given 500 cc of deionized water beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet."
329167|NCT00289120|P1|Participant Flow|Cola First, Then Water|"Phase 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.
There will be a three weeks wash-out period before patients entere phase 2 of thre study.
Phase 2: Subjects will be given 500cc of deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet."
329168|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
329169|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
329170|NCT00289120|O2|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
329171|NCT00289120|O1|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
329172|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
329173|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
329174|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
329175|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
329176|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
329177|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
329178|NCT00289120|O2|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
329180|NCT00289120|E2|Reported Event|Deionized Water Drinking Phase|"Subjects were given 500cc of regular deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.
No adverse event reported."
329181|NCT00289120|E1|Reported Event|Cola Beverage Phase|"Subjects were given 500cc of Cola twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.
There will be a three weeks interval (wash out period) before crossover to the other treatment arm.
No adverse event reported."
329182|NCT00289133|B3|Baseline|Total|Total of all reporting groups
329183|NCT00289133|B2|Baseline|XLK Poly|Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
329184|NCT00289133|B1|Baseline|GVF Poly|Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert
329185|NCT00289133|P2|Participant Flow|XLK Poly|Cross-linked polyethylene tibial component
329186|NCT00289133|P1|Participant Flow|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
329187|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
329188|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
329189|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
329190|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
329191|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
329192|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
329193|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
329194|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
329195|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
329196|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
329197|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
329198|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
329199|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene tibial component
329200|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
329201|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
329202|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
329203|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
329204|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert
329205|NCT00289133|E2|Reported Event|XLK Poly|Cross-linked polyethylene tibial component
329206|NCT00289133|E1|Reported Event|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
329207|NCT00289185|B3|Baseline|Total|Total of all reporting groups
329208|NCT00289185|B2|Baseline|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329209|NCT00289185|B1|Baseline|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329210|NCT00289185|P2|Participant Flow|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329211|NCT00289185|P1|Participant Flow|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329212|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329213|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329214|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329215|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329216|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329343|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
329712|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329217|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329218|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329219|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329220|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329221|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329222|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329223|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329224|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329225|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329226|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329227|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329269|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
329228|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329229|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329230|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329231|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329232|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329233|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329757|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329234|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329235|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329236|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329237|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329238|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329239|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329240|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329241|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329242|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329243|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329244|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329245|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329246|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329247|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
329248|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329249|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329250|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329758|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329251|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329252|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329253|NCT00289185|E2|Reported Event|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
329254|NCT00289185|E1|Reported Event|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
329255|NCT00289211|B4|Baseline|Total|Total of all reporting groups
329256|NCT00289211|B3|Baseline|Open-label C1INH-nf Only|Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only.
329257|NCT00289211|B2|Baseline|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
329258|NCT00289211|B1|Baseline|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
329259|NCT00289211|P3|Participant Flow|Open-label C1INH-nf Only|Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only.
329260|NCT00289211|P2|Participant Flow|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
329261|NCT00289211|P1|Participant Flow|C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
329262|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
329263|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
329264|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
329265|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
329266|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
329267|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
329268|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
329270|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
329271|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
329272|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
329273|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
329274|NCT00289211|E2|Reported Event|Placebo|
329275|NCT00289211|E1|Reported Event|C1INH-nf|
329276|NCT00289276|B3|Baseline|Total|Total of all reporting groups
329277|NCT00289276|B2|Baseline|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
329278|NCT00289276|B1|Baseline|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
329279|NCT00289276|P2|Participant Flow|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
329652|NCT00289874|O1|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
329653|NCT00289874|E2|Reported Event|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
329280|NCT00289276|P1|Participant Flow|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
329281|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
329282|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
329283|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
329284|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
329285|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
329286|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
329287|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
329288|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
329289|NCT00289276|E2|Reported Event|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
329290|NCT00289276|E1|Reported Event|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
329291|NCT00289289|B4|Baseline|Total|Total of all reporting groups
329292|NCT00289289|B3|Baseline|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
329293|NCT00289289|B2|Baseline|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
329294|NCT00289289|B1|Baseline|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
329390|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329295|NCT00289289|P3|Participant Flow|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
329296|NCT00289289|P2|Participant Flow|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
329297|NCT00289289|P1|Participant Flow|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
329298|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
329299|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
329300|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
329301|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
329302|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
329654|NCT00289874|E1|Reported Event|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
329655|NCT00289887|B3|Baseline|Total|Total of all reporting groups
329303|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
329304|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
329305|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
329306|NCT00289289|E3|Reported Event|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
329307|NCT00289289|E2|Reported Event|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
329308|NCT00289289|E1|Reported Event|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
329309|NCT00289341|B3|Baseline|Total|Total of all reporting groups
329310|NCT00289341|B2|Baseline|Placebo|
329311|NCT00289341|B1|Baseline|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
329312|NCT00289341|P2|Participant Flow|Placebo|
329313|NCT00289341|P1|Participant Flow|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
329314|NCT00289341|O1|Outcome|Pre-vs Post-vaccination PSA Slope|
329315|NCT00289341|O1|Outcome|Median Difference, Post-Pre Vaccination|For each antigen group, the difference between the post and pre-vaccination T cell proliferation response was calculated.
329316|NCT00289341|O2|Outcome|Placebo|12 patients receiving vehicle only
329317|NCT00289341|O1|Outcome|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
329318|NCT00289341|E4|Reported Event|Arm 1 and 2 Post-Vaccination Phase|unblinded
329319|NCT00289341|E3|Reported Event|Arm 2 Vaccine Phase|Unblinded
329320|NCT00289341|E2|Reported Event|Arm 1 Vaccine Phase|Single blind
329321|NCT00289341|E1|Reported Event|Arm 2 Placebo Phase|Single-blind
329322|NCT00289458|B4|Baseline|Total|Total of all reporting groups
329323|NCT00289458|B3|Baseline|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
329324|NCT00289458|B2|Baseline|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
329325|NCT00289458|B1|Baseline|Control Group|Continued with usual activity and care, no intervention
329326|NCT00289458|P3|Participant Flow|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
329327|NCT00289458|P2|Participant Flow|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
329328|NCT00289458|P1|Participant Flow|Control Group|Continued with usual activity and care, no intervention
329391|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329392|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329393|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329329|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
329330|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
329331|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
329332|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
329333|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
329334|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
329335|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
329336|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
329337|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
329338|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
329339|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
329340|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
329341|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
329344|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
329345|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
329346|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
329347|NCT00289458|E3|Reported Event|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
329348|NCT00289458|E2|Reported Event|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
329349|NCT00289458|E1|Reported Event|Control Group|Continued with usual activity and care, no intervention
329350|NCT00289471|B1|Baseline|Cognitive Screening|"Cognitive screening
No intervention delivered.: No intervention delivered."
329351|NCT00289471|P1|Participant Flow|Cognitive Screening|"Cognitive screening
No intervention delivered.: No intervention delivered."
329352|NCT00289471|O1|Outcome|Cognitive Screening|"Cognitive screening
No intervention delivered.: No intervention delivered."
329353|NCT00289471|E1|Reported Event|Cognitive Screening|"Cognitive screening
No intervention delivered.: No intervention delivered."
329354|NCT00289536|B1|Baseline|Treated Participants|Participants who received at least 1 infusion of rAHF-PFM.
329355|NCT00289536|P3|Participant Flow|High Dose|50 IU/kg rAHF-PFM
329356|NCT00289536|P2|Participant Flow|Medium Dose|30 IU/kg rAHF-PFM
329357|NCT00289536|P1|Participant Flow|Low Dose|15 IU/kg rAHF-PFM
329358|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329359|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329360|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329361|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329362|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329363|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329364|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329365|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329366|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329367|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329368|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329369|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329370|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329371|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329372|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329373|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329374|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329375|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329376|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329377|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329378|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329379|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329380|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329381|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329382|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329383|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329384|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329385|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329386|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329387|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
329388|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
329389|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
329395|NCT00289718|B1|Baseline|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
329396|NCT00289718|P1|Participant Flow|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
329397|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
329398|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
329399|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
329400|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
329401|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
330437|NCT00301262|O1|Outcome|DB Viagra Week 8|
329402|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
329403|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
329404|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
329405|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
329406|NCT00289718|E1|Reported Event|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
329407|NCT00289744|B1|Baseline|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
329408|NCT00289744|P3|Participant Flow|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
329409|NCT00289744|P2|Participant Flow|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
329410|NCT00289744|P1|Participant Flow|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
329411|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
329412|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
329413|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
329414|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
329415|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
329416|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
329417|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
329418|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
329419|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
329420|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
329421|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
329422|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
329423|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
329424|NCT00289744|E3|Reported Event|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
329425|NCT00289744|E2|Reported Event|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
329426|NCT00289744|E1|Reported Event|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
329427|NCT00289757|B1|Baseline|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
329428|NCT00289757|P1|Participant Flow|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
329656|NCT00289887|B2|Baseline|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
329429|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
329430|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
329431|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
329432|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
329433|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
329434|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
329435|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
329436|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
329437|NCT00289757|E1|Reported Event|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
329438|NCT00289770|B1|Baseline|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329439|NCT00289770|P1|Participant Flow|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329440|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329441|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329442|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329443|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329444|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329445|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329446|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329447|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329448|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329449|NCT00289770|E1|Reported Event|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
329450|NCT00289783|B3|Baseline|Total|Total of all reporting groups
329451|NCT00289783|B2|Baseline|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329452|NCT00289783|B1|Baseline|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329453|NCT00289783|P2|Participant Flow|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329454|NCT00289783|P1|Participant Flow|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329455|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329456|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329457|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329458|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329459|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329460|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329461|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329462|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329463|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329632|NCT00289848|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
329464|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329465|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329466|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329467|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329657|NCT00289887|B1|Baseline|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
329468|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329469|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329470|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329471|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329472|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329473|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329474|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329475|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329476|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329477|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329478|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329479|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329480|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329668|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
329481|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329482|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329483|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329484|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329485|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329486|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329487|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329488|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329489|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329490|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329491|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329492|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329493|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329658|NCT00289887|P2|Participant Flow|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
329494|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329495|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329496|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329497|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329498|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329499|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329500|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329501|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329502|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329503|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329504|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329505|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329506|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329659|NCT00289887|P1|Participant Flow|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
329507|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329508|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329509|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329510|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329511|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329512|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329513|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329514|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329515|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329516|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329517|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329518|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329519|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329660|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
329520|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329521|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329522|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329523|NCT00289783|O5|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329524|NCT00289783|O4|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329525|NCT00289783|O3|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329526|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329527|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329528|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329529|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329530|NCT00289783|O5|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329531|NCT00289783|O4|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329532|NCT00289783|O3|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329661|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
329533|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329534|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329535|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329536|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329537|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329538|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329539|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329540|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329541|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329542|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329543|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329544|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329545|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329662|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
329546|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329547|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329548|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329549|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329550|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329551|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329552|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329553|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329633|NCT00289848|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
329634|NCT00289848|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
330355|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
329554|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329555|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329556|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329557|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329558|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329663|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
329559|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329560|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329561|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329562|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329563|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329564|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329565|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329566|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329567|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329568|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329569|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329570|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329571|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329669|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
329572|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329573|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329574|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329575|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329576|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329577|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329578|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329579|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329580|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329581|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329582|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329583|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329584|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329664|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
329585|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329586|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329587|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329588|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329589|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329590|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329591|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329592|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329593|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329594|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329595|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329596|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329597|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329665|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
329598|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329599|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329600|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329601|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329602|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329603|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329604|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329605|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329606|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329607|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329608|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329609|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329610|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329666|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
329611|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329612|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329613|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329614|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329615|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329616|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329617|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329635|NCT00289848|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
329636|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
330356|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
329618|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329619|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329620|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329621|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329622|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329623|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329667|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
329624|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329625|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329626|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329627|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329628|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329629|NCT00289783|E2|Reported Event|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329630|NCT00289783|E1|Reported Event|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
329637|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
329638|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
329639|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
329640|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
329641|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
329642|NCT00289848|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
329643|NCT00289848|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
329644|NCT00289874|B3|Baseline|Total|Total of all reporting groups
329645|NCT00289874|B2|Baseline|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
329646|NCT00289874|B1|Baseline|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
329647|NCT00289874|P2|Participant Flow|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
329648|NCT00289874|P1|Participant Flow|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
329649|NCT00289874|O2|Outcome|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
329650|NCT00289874|O1|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
329651|NCT00289874|O2|Outcome|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
329670|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
329671|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
329672|NCT00289887|E2|Reported Event|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
329673|NCT00289887|E1|Reported Event|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
329674|NCT00289900|B7|Baseline|Total|Total of all reporting groups
329675|NCT00289900|B6|Baseline|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329676|NCT00289900|B5|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329677|NCT00289900|B4|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329678|NCT00289900|B3|Baseline|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329679|NCT00289900|B2|Baseline|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329680|NCT00289900|B1|Baseline|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329681|NCT00289900|P6|Participant Flow|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329682|NCT00289900|P5|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329683|NCT00289900|P4|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329684|NCT00289900|P3|Participant Flow|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329685|NCT00289900|P2|Participant Flow|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329686|NCT00289900|P1|Participant Flow|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329687|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329688|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329689|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329690|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329691|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329692|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329693|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329694|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329695|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329696|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329697|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329699|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329700|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329701|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329702|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329703|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329704|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329705|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329706|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329707|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329708|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329709|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329710|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329711|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329759|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329713|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
329714|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
329715|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329716|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329717|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329718|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329719|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329720|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329721|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329722|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329723|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329724|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329725|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329726|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329727|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329728|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329729|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329730|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329731|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329732|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329733|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329734|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329735|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329736|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329737|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329738|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329739|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329740|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329741|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329742|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329743|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
330357|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
329744|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329745|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329746|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329747|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329748|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329749|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329750|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329751|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329752|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329753|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329754|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329755|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329756|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
330438|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
329761|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329762|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329763|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329764|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329765|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329766|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329767|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329768|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329769|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329770|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329771|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329772|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329773|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329774|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329775|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329776|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329777|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329778|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329779|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329780|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329781|NCT00289900|E6|Reported Event|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
329782|NCT00289900|E5|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
329783|NCT00289900|E4|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
329784|NCT00289900|E3|Reported Event|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
329785|NCT00289900|E2|Reported Event|MK-0524B 2g/40 mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
329786|NCT00289900|E1|Reported Event|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
329787|NCT00289913|B6|Baseline|Total|Total of all reporting groups
329788|NCT00289913|B5|Baseline|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered."
329789|NCT00289913|B4|Baseline|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329790|NCT00289913|B3|Baseline|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329791|NCT00289913|B2|Baseline|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329792|NCT00289913|B1|Baseline|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329793|NCT00289913|P5|Participant Flow|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered."
329794|NCT00289913|P4|Participant Flow|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329795|NCT00289913|P3|Participant Flow|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329796|NCT00289913|P2|Participant Flow|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329797|NCT00289913|P1|Participant Flow|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329798|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered."
330215|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
329799|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329800|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329801|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329802|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329803|NCT00289913|O3|Outcome|VAQTA™/VAQTA™|All participants receiving VAQTA™ alone (from Stage II) on Day 1 and Day 24.
329804|NCT00289913|O2|Outcome|Non-concomitant VAQTA™ Separate From Infanrix™ and PedvaxHIB™|All participants receiving VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ were pooled for safety analysis; and includes participants from Groups 2: PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1); and Group 4: PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1).
329805|NCT00289913|O1|Outcome|Concomitant VAQTA™ With Infanrix™ and PedvaxHIB™ or PedvaxHIB™|All participants receiving VAQTA™ Concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ were pooled for safety analysis; and includes participants from Groups 1: VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1); and Group 3: VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1).
329806|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered."
329807|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329808|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329809|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329810|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329811|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered."
329812|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329813|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329814|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329815|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329816|NCT00289913|E5|Reported Event|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered."
329817|NCT00289913|E4|Reported Event|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage I)|"Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329920|NCT00290199|P2|Participant Flow|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
329818|NCT00289913|E3|Reported Event|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329819|NCT00289913|E2|Reported Event|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered."
329820|NCT00289913|E1|Reported Event|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered."
329821|NCT00289978|B4|Baseline|Total|Total of all reporting groups
329822|NCT00289978|B3|Baseline|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
329823|NCT00289978|B2|Baseline|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
329824|NCT00289978|B1|Baseline|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
329825|NCT00289978|P3|Participant Flow|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
329826|NCT00289978|P2|Participant Flow|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
329827|NCT00289978|P1|Participant Flow|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
329828|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
329829|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
329830|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
329831|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
329832|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
329833|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
329834|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
329835|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
329836|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
329837|NCT00289978|E3|Reported Event|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
329838|NCT00289978|E2|Reported Event|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
329839|NCT00289978|E1|Reported Event|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
329840|NCT00289991|B3|Baseline|Total|Total of all reporting groups
329841|NCT00289991|B2|Baseline|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329842|NCT00289991|B1|Baseline|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
329843|NCT00289991|P2|Participant Flow|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329844|NCT00289991|P1|Participant Flow|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen intravenous (IV) for first 24 hours: 6 milligrams per kilogram (mg/kg) of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) twice daily (BID) or 200 mg tablet or powder for oral suspension by mouth (PO) BID (subjects greater than or equal to [≥] 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects less than [<] 40 kg body weight).
329845|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329846|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
329847|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329848|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
329849|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329850|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
329851|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329852|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
329853|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329921|NCT00290199|P1|Participant Flow|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
329854|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
329855|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329856|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
329857|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329858|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
329859|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329860|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
329861|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329862|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
329863|NCT00289991|E2|Reported Event|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
329864|NCT00289991|E1|Reported Event|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
329865|NCT00290147|B3|Baseline|Total|Total of all reporting groups
329866|NCT00290147|B2|Baseline|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
329867|NCT00290147|B1|Baseline|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
329868|NCT00290147|P2|Participant Flow|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
329869|NCT00290147|P1|Participant Flow|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
329870|NCT00290147|O2|Outcome|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
329871|NCT00290147|O1|Outcome|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
329872|NCT00290147|O2|Outcome|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
329873|NCT00290147|O1|Outcome|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
329874|NCT00290147|E2|Reported Event|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
329875|NCT00290147|E1|Reported Event|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
329876|NCT00290186|B3|Baseline|Total|Total of all reporting groups
329877|NCT00290186|B2|Baseline|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329878|NCT00290186|B1|Baseline|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329879|NCT00290186|P2|Participant Flow|Hyperbaric Air Treatment (HBA)|"Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
24 Were allocated to HBA 22 Completed all 40 treatments
1 Withdrew prior to treatments
1 Withdrawn during treatments for seizures due to shunt malfunction 22 Completed post treatment testing
1 Study terminated prior to 3-month followup testing 21 Completed 3-month followup testing
1 Did not return for 6-month followup testing
1 Missed 6-month followup testing due to illness not related to study 19 Completed 6-month followup testing 22 Included in pre and post treatment analyses 21 Included in pre, post, and 3-month analyses 19 Included in pre, post, 3-month and 6-month analyses"
329922|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
329923|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
330358|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
329880|NCT00290186|P1|Participant Flow|Hyperbaric Oxygen Treatment (HBO)|"Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
25 Were allocated to HBO 24 Completed all 40 treatments
1 Withdrawn during treatments due to right ear problems and rectal bleeding 24 Completed post treatment testing
Study terminated prior to 3-month followup testing
Did not return for 3- or 6-month followup testing
1 Missed 3-month followup due to illness not related to study but returned for 6-month followup testing 20 Completed 3-month followup testing 20 Completed 6-month testing 24 Included in pre and post treatment analyses 20 Included in pre, post, and 3-month analyses 20 Included in pre, post, 3-month and 6-month analyses"
329881|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329882|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329883|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329884|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329885|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329886|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329887|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329888|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329889|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329890|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329891|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329892|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329893|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329894|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
330216|NCT00297102|E2|Reported Event|Placebo|once daily
329895|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329896|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329897|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329898|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329899|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329900|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329901|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329902|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329903|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329904|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329905|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329906|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329907|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329908|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329909|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329910|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329911|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|"14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total"
329912|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|"100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total"
329913|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329914|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329915|NCT00290186|E2|Reported Event|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329916|NCT00290186|E1|Reported Event|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
329917|NCT00290199|B3|Baseline|Total|Total of all reporting groups
329918|NCT00290199|B2|Baseline|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
329919|NCT00290199|B1|Baseline|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
329924|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
329925|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
329926|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
329927|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
329928|NCT00290199|O2|Outcome|No Foley|No transcervical foley catheter inserted to induce labor
329929|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a a transcervical foley catheter to induce labor
329930|NCT00290199|E2|Reported Event|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
329931|NCT00290199|E1|Reported Event|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
329932|NCT00290238|B3|Baseline|Total|Total of all reporting groups
329933|NCT00290238|B2|Baseline|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
329934|NCT00290238|B1|Baseline|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
329935|NCT00290238|P2|Participant Flow|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
329936|NCT00290238|P1|Participant Flow|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
330141|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
329937|NCT00290238|O2|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
329938|NCT00290238|O1|Outcome|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
329939|NCT00290238|O2|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
329940|NCT00290238|O1|Outcome|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
329941|NCT00290238|E2|Reported Event|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
329942|NCT00290238|E1|Reported Event|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
329943|NCT00290251|B1|Baseline|Eligible Women|All women who consented and were eligible
329944|NCT00290251|P3|Participant Flow|Placebo (PLC)|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
329945|NCT00290251|P2|Participant Flow|Ulipristal Acetate- 10 mg|Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.
329946|NCT00290251|P1|Participant Flow|Ulipristal Acetate - 20 mg|Women received ulipristal acetate at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.
329947|NCT00290251|O2|Outcome|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
329948|NCT00290251|O1|Outcome|Ulipristal Acetate -10 and 20mg|Women received ulipristal acetate at a daily dose of 10 or 20 mg for 90 - 102 days or three menstrual cycles.
329949|NCT00290251|O3|Outcome|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
329950|NCT00290251|O2|Outcome|Ulipristal Acetate - 10 mg|Women received ulipristal acetate at 10 mg/day for 90 - 102 days or three menstrual cycles.
329951|NCT00290251|O1|Outcome|Ulipristal Acetate -20mg|Women received ulipristal acetate at 20 mg/day for 90 - 102 days or three menstrual cycles.
329952|NCT00290251|E3|Reported Event|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
329953|NCT00290251|E2|Reported Event|CDB-2914 - 10 mg|Women received CDB-2914 at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.
329954|NCT00290251|E1|Reported Event|CDB-2914 -20mg|Women received CDB-2914 at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.
329955|NCT00290290|B3|Baseline|Total|Total of all reporting groups
329956|NCT00290290|B2|Baseline|Chlorhexidine-alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
329957|NCT00290290|B1|Baseline|Povidone-iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
329958|NCT00290290|P2|Participant Flow|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
329959|NCT00290290|P1|Participant Flow|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
329960|NCT00290290|O2|Outcome|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
329961|NCT00290290|O1|Outcome|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
329962|NCT00290290|E2|Reported Event|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
329963|NCT00290290|E1|Reported Event|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
329964|NCT00290329|B4|Baseline|Total|Total of all reporting groups
329965|NCT00290329|B3|Baseline|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329966|NCT00290329|B2|Baseline|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329967|NCT00290329|B1|Baseline|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329968|NCT00290329|P3|Participant Flow|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329969|NCT00290329|P2|Participant Flow|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329970|NCT00290329|P1|Participant Flow|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329971|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329972|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
330210|NCT00297102|O2|Outcome|Placebo|once daily
330211|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
329973|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329974|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329975|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329976|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329977|NCT00290329|O2|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329978|NCT00290329|O1|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329979|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329980|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329981|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329982|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329983|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329984|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329985|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329986|NCT00290329|E3|Reported Event|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329987|NCT00290329|E2|Reported Event|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329988|NCT00290329|E1|Reported Event|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
329989|NCT00290407|B1|Baseline|RITUXIMAB PLUS ORAL Β-GLUCAN|
329990|NCT00290407|P1|Participant Flow|RITUXIMAB PLUS ORAL Β-GLUCAN|
329991|NCT00290407|O1|Outcome|RITUXIMAB PLUS ORAL Β-GLUCAN|
329992|NCT00290407|E1|Reported Event|RITUXIMAB PLUS ORAL Β-GLUCAN|
329993|NCT00290472|B4|Baseline|Total|Total of all reporting groups
330082|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
329994|NCT00290472|B3|Baseline|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
329995|NCT00290472|B2|Baseline|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
329996|NCT00290472|B1|Baseline|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
329997|NCT00290472|P3|Participant Flow|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
329998|NCT00290472|P2|Participant Flow|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
329999|NCT00290472|P1|Participant Flow|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
330212|NCT00297102|O2|Outcome|Placebo|once daily
330213|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
330000|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
330001|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
330002|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
330003|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
330004|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
330005|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
330006|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
330007|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
330008|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
330009|NCT00290472|E1|Reported Event|Temsirolimus|All patients
330010|NCT00290537|B1|Baseline|ZD6474|Part One: three 3-week cycles 300 mg of ZD6474 daily.
330011|NCT00290537|P2|Participant Flow|Part Two: ZD6474 + Carboplatin + Paclitaxel|Second part of two part treatment, Part One /Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks.
330012|NCT00290537|P1|Participant Flow|Part One: ZD6474|First part of two part treatment, Part One: three 3-week cycles 300 mg of ZD6474 daily. Second part, Part Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks
330359|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330013|NCT00290537|O2|Outcome|ZD6474 + Carboplatin + Paclitaxel|Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
330014|NCT00290537|O1|Outcome|ZD6474|First part of treatment: three 3-week cycles 300 mg of ZD6474 daily. Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
330015|NCT00290537|E1|Reported Event|ZD6474|Part One: three 3-week cycles 300 mg of ZD6474 daily.
330016|NCT00290615|B1|Baseline|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.
Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.
Cycles are 21 days."
330017|NCT00290615|P1|Participant Flow|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.
Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.
Cycles are 21 days."
330018|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.
Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.
Cycles are 21 days."
330019|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.
Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.
Cycles are 21 days."
330049|NCT00290732|O3|Outcome|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
330214|NCT00297102|O2|Outcome|Placebo|once daily
330020|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.
Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.
Cycles are 21 days."
330021|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.
Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.
Cycles are 21 days."
330022|NCT00290615|E1|Reported Event|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.
Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.
Cycles are 21 days."
330023|NCT00290654|B1|Baseline|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
330024|NCT00290654|P1|Participant Flow|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
330025|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
330026|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
330027|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
330028|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
330029|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
330030|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
330031|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
330032|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
330033|NCT00290654|E1|Reported Event|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
330034|NCT00290693|B1|Baseline|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks
Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
330035|NCT00290693|P1|Participant Flow|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks
Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
330036|NCT00290693|O1|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks
Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
330037|NCT00290693|O1|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks
Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
330038|NCT00290693|E1|Reported Event|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks
Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
330039|NCT00290732|B3|Baseline|Total|Total of all reporting groups
330040|NCT00290732|B2|Baseline|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
330041|NCT00290732|B1|Baseline|Intraductal Arm|Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
330042|NCT00290732|P5|Participant Flow|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
330043|NCT00290732|P4|Participant Flow|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
330044|NCT00290732|P3|Participant Flow|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
330045|NCT00290732|P2|Participant Flow|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
330046|NCT00290732|P1|Participant Flow|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
330047|NCT00290732|O5|Outcome|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
330048|NCT00290732|O4|Outcome|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
330050|NCT00290732|O2|Outcome|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
330051|NCT00290732|O1|Outcome|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
330052|NCT00290732|O5|Outcome|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
330053|NCT00290732|O4|Outcome|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
330054|NCT00290732|O3|Outcome|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
330055|NCT00290732|O2|Outcome|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
330056|NCT00290732|O1|Outcome|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
330057|NCT00290732|O1|Outcome|Intraductal Arm|Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
330058|NCT00290732|E5|Reported Event|Intravenous Arm|Note: Adverse events were not collected in the intravenous group/arm; only the concentration of doxorubicin in tissue applied to this group of participants.
330059|NCT00290732|E4|Reported Event|Intraductal Arm- 10 mg PLD|
330060|NCT00290732|E3|Reported Event|Intraductal Arm- 5 mg PLD|
330061|NCT00290732|E2|Reported Event|Intraductal Arm- 2 mg PLD|
330062|NCT00290732|E1|Reported Event|Intraductal Arm- 0 mg PLD|
330063|NCT00290758|B3|Baseline|Total|Total of all reporting groups
330064|NCT00290758|B2|Baseline|Arm B|Patients receive oral placebo once daily for up to 6 months.
330065|NCT00290758|B1|Baseline|Arm A|Patients receive oral genistein once daily for up to 6 months.
330066|NCT00290758|P2|Participant Flow|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
330067|NCT00290758|P1|Participant Flow|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
330068|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
330069|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
330070|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
330071|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
330072|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
330073|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
330074|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
330075|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
330076|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
330077|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
330078|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
330079|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
330080|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
330081|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
330083|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
330084|NCT00290758|E2|Reported Event|Arm B (Placebo)|Patients take oral placebo once daily for up to 6 months.
330085|NCT00290758|E1|Reported Event|Arm A (Genistein)|Patients take oral genistein once daily for up to 6 months.
330086|NCT00290771|B3|Baseline|Total|Total of all reporting groups
330087|NCT00290771|B2|Baseline|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330088|NCT00290771|B1|Baseline|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330089|NCT00290771|P2|Participant Flow|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330090|NCT00290771|P1|Participant Flow|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330139|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330091|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
330092|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330093|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330094|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
330095|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330096|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330097|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
330098|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330099|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330120|NCT00290888|B1|Baseline|Arthroscopic Rotator Cuff Repair Without Acromioplasty|Arthroscopic rotator cuff repair without acromioplasty (ACR)
330121|NCT00290888|P2|Participant Flow|Arthorscopic Rotator Cuff Repair With Acromioplasty|"ACR-A
Acromioplasty"
330360|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
330100|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
330101|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330102|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330103|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
330104|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330105|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330106|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
330107|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330108|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330109|NCT00290771|E2|Reported Event|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330110|NCT00290771|E1|Reported Event|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
330111|NCT00290810|B1|Baseline|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
330112|NCT00290810|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
330113|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
330114|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
330115|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
330116|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
330117|NCT00290810|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
330118|NCT00290888|B3|Baseline|Total|Total of all reporting groups
330119|NCT00290888|B2|Baseline|Arthroscopic Rotator Cuff Repair With Acromioplasty|Arthroscopic rotator cuff repair with acromioplasty (ACR-A)
330122|NCT00290888|P1|Participant Flow|Arthroscopic Rotator Cuff Repair Without Acromioplasty|"ACR
Acromioplasty"
330123|NCT00290888|O2|Outcome|Arthorscopic Rotator Cuff Repair With Acromioplasty|ACR-A Acromioplasty
330124|NCT00290888|O1|Outcome|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
330125|NCT00290888|O2|Outcome|Arthroscopic Rotator Cuff Repair With Acromioplasty|"ACR-A
Acromioplasty"
330126|NCT00290888|O1|Outcome|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
330127|NCT00290888|E2|Reported Event|Arthroscopic Rotator Cuff Repair With Acromioplasty|"ACR-A
Acromioplasty"
330128|NCT00290888|E1|Reported Event|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
330129|NCT00291018|B4|Baseline|Total|Total of all reporting groups
330130|NCT00291018|B3|Baseline|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized"
330131|NCT00291018|B2|Baseline|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized"
330132|NCT00291018|B1|Baseline|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized"
330133|NCT00291018|P3|Participant Flow|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330134|NCT00291018|P2|Participant Flow|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330135|NCT00291018|P1|Participant Flow|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
330136|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330137|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330138|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
330140|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330309|NCT00301080|E2|Reported Event|D-cycloserine 250mg|
330142|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330143|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330144|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
330145|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330146|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330147|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
330148|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330149|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330150|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
330151|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330152|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330153|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
330154|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330155|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330156|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
330157|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330158|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330159|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
330160|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330161|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330162|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
330163|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330164|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330165|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
330166|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized"
330167|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized"
330168|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized"
330169|NCT00291018|E3|Reported Event|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Non-Randomized Group"
330170|NCT00291018|E2|Reported Event|Control|"Anterior Cervical Discectomy and Fusion
ACDF
Randomized Group"
330171|NCT00291018|E1|Reported Event|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Total Disc Replacement
Randomized Group"
330172|NCT00296816|B3|Baseline|Total|Total of all reporting groups
330173|NCT00296816|B2|Baseline|Oxaliplatin/Docetaxel/Bevacizumab (Non-Measurable Disease)|"Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, who did not have a measurable disease at baseline.
Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension."
330174|NCT00296816|B1|Baseline|Oxaliplatin/Docetaxel/Bevacizumab (Measurable Disease)|"Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, with a measurable disease at baseline.
Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension."
330175|NCT00296816|P1|Participant Flow|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
330176|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
330177|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
330178|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
330179|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
330180|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
330181|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
330182|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
330183|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
330184|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
330185|NCT00296816|E1|Reported Event|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
330186|NCT00297037|B3|Baseline|Total|Total of all reporting groups
330187|NCT00297037|B2|Baseline|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
330188|NCT00297037|B1|Baseline|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
330189|NCT00297037|P2|Participant Flow|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
330190|NCT00297037|P1|Participant Flow|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
330191|NCT00297037|O2|Outcome|Vehicle|During the 6 week double blind phase all patients were randomly assigned to receive either pimecrolimus 1% cream or vehicle twice daily with occlusion on the affected areas.
330192|NCT00297037|O1|Outcome|Pimecrolimus Cream|During the 6 week double blind phase all patients were randomly assigned to receive either pimecrolimus 1% cream or vehicle twice daily with occlusion on the affected areas.
330193|NCT00297037|O2|Outcome|Vehicle Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
330361|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
330194|NCT00297037|O1|Outcome|Pimecrolimus Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
330195|NCT00297037|O2|Outcome|Vehicle Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
330196|NCT00297037|O1|Outcome|Pimecrolimus Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
330197|NCT00297037|E2|Reported Event|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
330198|NCT00297037|E1|Reported Event|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
330199|NCT00297102|B3|Baseline|Total|Total of all reporting groups
330200|NCT00297102|B2|Baseline|Placebo|once daily
330201|NCT00297102|B1|Baseline|Roflumilast|500 mcg, once daily, oral administration in the morning
330202|NCT00297102|P2|Participant Flow|Placebo|once daily
330203|NCT00297102|P1|Participant Flow|Roflumilast|500 mcg, once daily, oral administration in the morning
330204|NCT00297102|O2|Outcome|Placebo|once daily
330205|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
330206|NCT00297102|O2|Outcome|Placebo|once daily
330207|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
330208|NCT00297102|O2|Outcome|Placebo|once daily
330209|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
330217|NCT00297102|E1|Reported Event|Roflumilast|500 mcg, once daily, oral administration in the morning
330218|NCT00300677|B1|Baseline|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
330219|NCT00300677|P1|Participant Flow|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
330220|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
330221|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
330222|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
330223|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
330224|NCT00300677|E1|Reported Event|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
330225|NCT00300742|B1|Baseline|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
330226|NCT00300742|P1|Participant Flow|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
330227|NCT00300742|O1|Outcome|Topiramate/BBCET|Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
330228|NCT00300742|O1|Outcome|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
330229|NCT00300742|O1|Outcome|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
330230|NCT00300742|O1|Outcome|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
330231|NCT00300742|O1|Outcome|Topiramate/BBCET|Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
330232|NCT00300742|E1|Reported Event|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
330233|NCT00300755|B4|Baseline|Total|Total of all reporting groups
330234|NCT00300755|B3|Baseline|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
330235|NCT00300755|B2|Baseline|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
330236|NCT00300755|B1|Baseline|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
330237|NCT00300755|P3|Participant Flow|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
330238|NCT00300755|P2|Participant Flow|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
330239|NCT00300755|P1|Participant Flow|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
330240|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
330362|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
330241|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
330242|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
330243|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
330244|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
330245|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
330246|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
330247|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
330248|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
330249|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
330250|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
330251|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
330310|NCT00301080|E1|Reported Event|Placebo (Original Version)|
330311|NCT00301262|B3|Baseline|Total|Total of all reporting groups
330439|NCT00301262|O3|Outcome|DB Placebo Week 8|
330440|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330252|NCT00300755|E3|Reported Event|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
330253|NCT00300755|E2|Reported Event|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
330254|NCT00300755|E1|Reported Event|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
330255|NCT00300885|B3|Baseline|Total|Total of all reporting groups
330256|NCT00300885|B2|Baseline|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
330257|NCT00300885|B1|Baseline|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
330258|NCT00300885|P2|Participant Flow|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
330259|NCT00300885|P1|Participant Flow|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
330260|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
330261|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
330262|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
330263|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
330289|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
330290|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
330264|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
330265|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
330266|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
330267|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
330268|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
330269|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
330270|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
330312|NCT00301262|B2|Baseline|Start : DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
330271|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
330272|NCT00300885|E2|Reported Event|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
330273|NCT00300885|E1|Reported Event|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
330274|NCT00301028|B1|Baseline|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
330275|NCT00301028|P1|Participant Flow|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin Area Under the Curve (AUC) 2 and Paclitaxel 135 mg/m^2 for 6 courses.
330276|NCT00301028|O1|Outcome|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
330277|NCT00301028|E1|Reported Event|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
330278|NCT00301080|B1|Baseline|All Participants (Original Version)|All 7 patients enrolled were during the original version of the study design (2 arms: d-cycloserine 250mg vs. placebo - twice daily for 4 weeks). Since the study went on to change design and then terminate prior to completing accrual, it is not useful to report baseline measures by the original arms/groups.
330279|NCT00301080|P5|Participant Flow|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 12 weeks.
330280|NCT00301080|P4|Participant Flow|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
330281|NCT00301080|P3|Participant Flow|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
330282|NCT00301080|P2|Participant Flow|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
330283|NCT00301080|P1|Participant Flow|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
330284|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
330285|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
330286|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
330287|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
330288|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
330291|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
330292|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
330293|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
330294|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
330295|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
330296|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
330297|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
330298|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
330299|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
330300|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
330301|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
330302|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
330303|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
330304|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
330305|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
330306|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
330307|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
330308|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
330313|NCT00301262|B1|Baseline|Start : DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks).
330314|NCT00301262|P2|Participant Flow|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
330315|NCT00301262|P1|Participant Flow|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
330316|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
330317|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
330318|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
330319|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330320|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
330321|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
330322|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
330323|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330324|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
330325|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
330326|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
330327|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330328|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
330329|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
330330|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
330331|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330332|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
330333|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
330334|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
330335|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330336|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
330337|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
330338|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
330339|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330340|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
330341|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
330342|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
330343|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330344|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
330345|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
330346|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
330347|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330348|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
330349|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
330350|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
330351|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330363|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330364|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
330365|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
330366|NCT00301262|O2|Outcome|DB Placebo Baseline to < Week 8|
330367|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
330368|NCT00301262|O2|Outcome|DB Placebo / OL Viagra|
330369|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
330370|NCT00301262|O2|Outcome|DB Placebo / OL Viagra|
330371|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
330372|NCT00301262|O2|Outcome|DB Placebo/ OL Viagra|
330373|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
330374|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330375|NCT00301262|O3|Outcome|DB Placebo Week 8|
330376|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330377|NCT00301262|O1|Outcome|DB Viagra Week 8|
330378|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330379|NCT00301262|O3|Outcome|DB Placebo Week 8|
330380|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330381|NCT00301262|O1|Outcome|DB Viagra Week 8|
330382|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330383|NCT00301262|O3|Outcome|DB Placebo Week 8|
330384|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330385|NCT00301262|O1|Outcome|DB Viagra Week 8|
330386|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330387|NCT00301262|O3|Outcome|DB Placebo Week 8|
330388|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330390|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
330391|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
330392|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
330393|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
330394|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
330395|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
330396|NCT00301262|O2|Outcome|DB Placebo|
330397|NCT00301262|O1|Outcome|DB Viagra|
330398|NCT00301262|O2|Outcome|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
330399|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
330400|NCT00301262|O2|Outcome|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
330401|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
330402|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
330403|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
330404|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
330405|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
330406|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
330407|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
330408|NCT00301262|O2|Outcome|Week 8 DB Placebo|
330409|NCT00301262|O1|Outcome|Week 8 DB Viagra|
330410|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
330411|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
330412|NCT00301262|O2|Outcome|Week 8 DB Placebo|
330413|NCT00301262|O1|Outcome|Week 8 DB Viagra|
330414|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
330415|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
330416|NCT00301262|O2|Outcome|Week 8 DB Placebo|
330417|NCT00301262|O1|Outcome|Week 8 DB Viagra|
330418|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330419|NCT00301262|O3|Outcome|DB Placebo Week 8|
330420|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330421|NCT00301262|O1|Outcome|DB Viagra Week 8|
330422|NCT00301262|O2|Outcome|DB Placebo|
330423|NCT00301262|O1|Outcome|DB Viagra|
330424|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330425|NCT00301262|O3|Outcome|DB Placebo Week 8|
330426|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330427|NCT00301262|O1|Outcome|DB Viagra Week 8|
330428|NCT00301262|O2|Outcome|DB Placebo|
330429|NCT00301262|O1|Outcome|DB Viagra|
330430|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330431|NCT00301262|O3|Outcome|DB Placebo Week 8|
330432|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330433|NCT00301262|O1|Outcome|DB Viagra Week 8|
330434|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330435|NCT00301262|O3|Outcome|DB Placebo Week 8|
330436|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330441|NCT00301262|O1|Outcome|DB Viagra Week 8|
330442|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330443|NCT00301262|O3|Outcome|DB Placebo Week 8|
330444|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330445|NCT00301262|O1|Outcome|DB Viagra Week 8|
330446|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330447|NCT00301262|O3|Outcome|DB Placebo Week 8|
330448|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330449|NCT00301262|O1|Outcome|DB Viagra Week 8|
330450|NCT00301262|O2|Outcome|DB Placebo|
330451|NCT00301262|O1|Outcome|DB Viagra|
330452|NCT00301262|O2|Outcome|DB Placebo|
330453|NCT00301262|O1|Outcome|DB Viagra|
330454|NCT00301262|O2|Outcome|DB Placebo|
330455|NCT00301262|O1|Outcome|DB Viagra|
330456|NCT00301262|O2|Outcome|DB Placebo|
330457|NCT00301262|O1|Outcome|DB Viagra|
330458|NCT00301262|O2|Outcome|DB Placebo|
330459|NCT00301262|O1|Outcome|DB Viagra|
330460|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330461|NCT00301262|O3|Outcome|DB Placebo Week 8|
330462|NCT00301262|O2|Outcome|DB Viagra /OL Viagra Week 14|
330463|NCT00301262|O1|Outcome|DB Viagra Week 8|
330464|NCT00301262|O2|Outcome|DB Placebo|
330465|NCT00301262|O1|Outcome|DB Viagra|
330466|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
330467|NCT00301262|O3|Outcome|DB Placebo Week 8|
330468|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
330469|NCT00301262|O1|Outcome|DB Viagra Week 8|
330470|NCT00301262|O2|Outcome|DB Placebo|
330471|NCT00301262|O1|Outcome|DB Viagra|
330472|NCT00301366|B1|Baseline|Entered Study|
330473|NCT00301366|P1|Participant Flow|Alpha-1MP Treatment Group|All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
330474|NCT00301366|O1|Outcome|Alpha-1 MP Treatment Group|
330475|NCT00301366|E1|Reported Event|Alpha-1MP Treatment Group|All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
330476|NCT00301418|B1|Baseline|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
330477|NCT00301418|P1|Participant Flow|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
330478|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
330479|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
330526|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
330527|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
330887|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
330888|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
330480|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
330481|NCT00301418|E1|Reported Event|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
330482|NCT00301756|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
330483|NCT00301756|P1|Participant Flow|Treatment (Belinostat / Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
330484|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV"
330485|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV"
330539|NCT00302055|B2|Baseline|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
330486|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV"
330487|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV"
330488|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV"
330489|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
330490|NCT00301756|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
330491|NCT00301808|B1|Baseline|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
330492|NCT00301808|P1|Participant Flow|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
330493|NCT00301808|O1|Outcome|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
330494|NCT00301808|E1|Reported Event|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
330495|NCT00301821|B1|Baseline|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
330496|NCT00301821|P1|Participant Flow|Epratuzumab + Rituximab + CHOP|One arm open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate
330497|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
330498|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
330499|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
330500|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
330501|NCT00301821|E1|Reported Event|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
330558|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330502|NCT00301834|B1|Baseline|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
330503|NCT00301834|P1|Participant Flow|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
330504|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
330505|NCT00301834|O2|Outcome|CMV Seropositive Participants|"seropositivity means the presence of anti-CMV IgG, indicating past infection by the virus"
330506|NCT00301834|O1|Outcome|CMV Seronegative Participants|"seronegativity means no detected presence of anti-CMV IgG, indicating no past infection by the virus"
330507|NCT00301834|O1|Outcome|Single Arm|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
330508|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
330509|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
330540|NCT00302055|B1|Baseline|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
330541|NCT00302055|P2|Participant Flow|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
330510|NCT00301834|E1|Reported Event|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
330511|NCT00301873|B1|Baseline|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
330512|NCT00301873|P1|Participant Flow|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
330513|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
330514|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
330515|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
330516|NCT00301873|E1|Reported Event|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
330517|NCT00301964|B1|Baseline|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies"
330518|NCT00301964|P1|Participant Flow|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies"
330519|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies"
330520|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies"
330521|NCT00301964|E1|Reported Event|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies"
330522|NCT00302003|B1|Baseline|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.
radiation therapy: Undergo radiation therapy
doxorubicin hydrochloride: Given IV
vincristine sulfate: Given IV
prednisone: Given orally
cyclophosphamide: Given IV
ifosfamide: Given IV
vinorelbine tartrate: Given IV
dexamethasone: Given IV
etoposide phosphate: Given IV
cisplatin: Given IV
cytarabine: Given IV
filgrastim: Given IV or subcutaneously"
330523|NCT00302003|P1|Participant Flow|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.
radiation therapy: Undergo radiation therapy
doxorubicin hydrochloride: Given IV
vincristine sulfate: Given IV
prednisone: Given orally
cyclophosphamide: Given IV
ifosfamide: Given IV
vinorelbine tartrate: Given IV
dexamethasone: Given IV
etoposide phosphate: Given IV
cisplatin: Given IV
cytarabine: Given IV
filgrastim: Given IV or subcutaneously"
330524|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
330525|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
330528|NCT00302003|E1|Reported Event|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.
radiation therapy: Undergo radiation therapy
doxorubicin hydrochloride: Given IV
vincristine sulfate: Given IV
prednisone: Given orally
cyclophosphamide: Given IV
ifosfamide: Given IV
vinorelbine tartrate: Given IV
dexamethasone: Given IV
etoposide phosphate: Given IV
cisplatin: Given IV
cytarabine: Given IV
filgrastim: Given IV or subcutaneously"
330529|NCT00302042|B3|Baseline|Total|Total of all reporting groups
330530|NCT00302042|B2|Baseline|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
330531|NCT00302042|B1|Baseline|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
330532|NCT00302042|P2|Participant Flow|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
330533|NCT00302042|P1|Participant Flow|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
330534|NCT00302042|O2|Outcome|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
330535|NCT00302042|O1|Outcome|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
330536|NCT00302042|E2|Reported Event|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
330537|NCT00302042|E1|Reported Event|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
330538|NCT00302055|B3|Baseline|Total|Total of all reporting groups
330542|NCT00302055|P1|Participant Flow|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
330543|NCT00302055|O2|Outcome|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
330544|NCT00302055|O1|Outcome|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
330545|NCT00302055|E2|Reported Event|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
330546|NCT00302055|E1|Reported Event|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
330547|NCT00302068|B4|Baseline|Total|Total of all reporting groups
330548|NCT00302068|B3|Baseline|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330549|NCT00302068|B2|Baseline|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330550|NCT00302068|B1|Baseline|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
330551|NCT00302068|P3|Participant Flow|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330552|NCT00302068|P2|Participant Flow|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330553|NCT00302068|P1|Participant Flow|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
330554|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330555|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330556|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
330557|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330889|NCT00294060|E1|Reported Event|Pacing Patients|Patients implanted with a pacemaker.
330559|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
330560|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330561|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330562|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
330563|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330589|NCT00302081|E2|Reported Event|PEG2b 1.0/R*(24 Weeks)|
330590|NCT00302081|E1|Reported Event|PEG2b 1.5/R*(24 Weeks)|
330591|NCT00302107|B3|Baseline|Total|Total of all reporting groups
330564|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330565|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
330566|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330567|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330568|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
330569|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects..
330570|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330571|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
330572|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330573|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330574|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
330575|NCT00302068|E3|Reported Event|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330576|NCT00302068|E2|Reported Event|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
330890|NCT00303108|B4|Baseline|Total|Total of all reporting groups
330577|NCT00302068|E1|Reported Event|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
330578|NCT00302081|B4|Baseline|Total|Total of all reporting groups
330579|NCT00302081|B3|Baseline|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
330580|NCT00302081|B2|Baseline|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
330581|NCT00302081|B1|Baseline|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
330582|NCT00302081|P3|Participant Flow|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
330583|NCT00302081|P2|Participant Flow|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
330584|NCT00302081|P1|Participant Flow|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
330585|NCT00302081|O3|Outcome|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
330586|NCT00302081|O2|Outcome|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
330587|NCT00302081|O1|Outcome|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
330588|NCT00302081|E3|Reported Event|PEG2b 1.5/R*(16 Weeks)|
330592|NCT00302107|B2|Baseline|Placebo|Placebo up to three tablets qhs
330593|NCT00302107|B1|Baseline|Mirtazapine|Mirtazapine up to 45 mg/qhs as tolerated
330594|NCT00302107|P2|Participant Flow|Placebo|Placebo up to three pills qhs
330595|NCT00302107|P1|Participant Flow|Mirtazapine|Mirtazapine up to 45mg/qhs (three 15mg pills) as tolerated.
330596|NCT00302107|O2|Outcome|Placebo|Placebo up to 3 tablets qhs
330597|NCT00302107|O1|Outcome|Mirtazapine|Mirtazapine up to 45mg/qhs as tolerated
330598|NCT00302107|E2|Reported Event|Placebo|Placebo up to 3 tablets qhs
330599|NCT00302107|E1|Reported Event|Mirtazapine|Mirtazapine up to 45mg/qhs as tolerated
330600|NCT00302133|B3|Baseline|Total|Total of all reporting groups
330601|NCT00302133|B2|Baseline|Placebo|"Placebo add on to valproate open label
Placebo add on to open label valproate for 12 weeks"
330602|NCT00302133|B1|Baseline|Naltrexone|"Naltrexone add on to valproate open label
naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
330603|NCT00302133|P2|Participant Flow|Placebo|"Placebo add on to valproate open label
Placebo one capsule daily for 12 weeks"
330604|NCT00302133|P1|Participant Flow|Naltrexone|"Naltrexone add on to valproate open label
Naltrexone Hydrochloride 50 mg daily for 12 weeks"
330605|NCT00302133|O2|Outcome|Placebo|"Placebo add on to valproate open label
Placebo add on to open label valproate for 12 weeks"
330606|NCT00302133|O1|Outcome|Naltrexone|"Naltrexone add on to valproate open label
naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
330607|NCT00302133|O2|Outcome|Placebo|"Placebo add on to valproate open label
Placebo add on to open label valproate for 12 weeks"
330608|NCT00302133|O1|Outcome|Naltrexone|"Naltrexone add on to valproate open label
naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
330609|NCT00302133|E2|Reported Event|Placebo|"Placebo add on to valproate open label
Placebo add on to open label valproate for 12 weeks"
330610|NCT00302133|E1|Reported Event|Naltrexone|"Naltrexone add on to valproate open label
naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
330611|NCT00302159|B1|Baseline|Valproic Acid|"adjuvant therapy
Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
330612|NCT00302159|P1|Participant Flow|Valproic Acid|"adjuvant therapy
Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
330613|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
adjuvant therapy
Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
330614|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
adjuvant therapy
Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
330615|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
adjuvant therapy
Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
330616|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
adjuvant therapy
Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
330617|NCT00302159|O1|Outcome|Valproic Acid|"adjuvant therapy
Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
330618|NCT00302159|O1|Outcome|Valproic Acid|"adjuvant therapy
Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
330619|NCT00302159|E1|Reported Event|Valproic Acid|"adjuvant therapy
Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
330620|NCT00302211|B4|Baseline|Total|Total of all reporting groups
330621|NCT00302211|B3|Baseline|Placebo 6×/Day + Sildenafil +/- Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
330622|NCT00302211|B2|Baseline|Iloprost 4×/Day + Placebo 2x/Day + Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
330623|NCT00302211|B1|Baseline|Iloprost(5 μg) 6×/Day Plus Sildenafil +/- Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
330624|NCT00302211|P5|Participant Flow|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
330625|NCT00302211|P4|Participant Flow|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
330626|NCT00302211|P3|Participant Flow|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
330779|NCT00294047|B3|Baseline|Total|Total of all reporting groups
330627|NCT00302211|P2|Participant Flow|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
330628|NCT00302211|P1|Participant Flow|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
330629|NCT00302211|O5|Outcome|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
330630|NCT00302211|O4|Outcome|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
330631|NCT00302211|O3|Outcome|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
330632|NCT00302211|O2|Outcome|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
330633|NCT00302211|O1|Outcome|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
330634|NCT00302211|E5|Reported Event|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
330635|NCT00302211|E4|Reported Event|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
330636|NCT00302211|E3|Reported Event|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
330637|NCT00302211|E2|Reported Event|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
330638|NCT00302211|E1|Reported Event|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
330639|NCT00302328|B4|Baseline|Total|Total of all reporting groups
330640|NCT00302328|B3|Baseline|tb Peeling|trypan blue (tb) peeling
330641|NCT00302328|B2|Baseline|ICG Peeling|indocyanine green (ICG) peeling
330642|NCT00302328|B1|Baseline|no Peeling|no peeling used
330643|NCT00302328|P3|Participant Flow|tb Peeling|trypan blue (tb) peeling
330644|NCT00302328|P2|Participant Flow|ICG Peeling|indocyanine (ICG) peeling
330645|NCT00302328|P1|Participant Flow|no Peeling|no peeling used
330646|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assisted ilm peeling
330647|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg assited ilm peeling
330648|NCT00302328|O1|Outcome|no Peeling|vitrectomy without ilm peeling
330649|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assited ilm peeling
330650|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg assited ilm peeling
330651|NCT00302328|O1|Outcome|no Peeling|vitrectomy without ilm peeling
330652|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assisted ilm peeling
330653|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg-assisted ilm peeling
330654|NCT00302328|O1|Outcome|no Peeling|Vitrectomy without peeling
330655|NCT00302328|E3|Reported Event|tb Peeling|vitrectomy with trypan blue assited ilm peeling
330656|NCT00302328|E2|Reported Event|ICG Peeling|vitrectomy with icg assited ilm peeling
330657|NCT00302328|E1|Reported Event|no Peeling|vitrectomy without ilm peeling
330658|NCT00302458|B1|Baseline|Healthy Volunteers|Healthy volunteers each received IR-MPH, OROS-MPH, and matched placebo (in four separate visits) in a four way crossover design.
330659|NCT00302458|P1|Participant Flow|Healthy Volunteers|Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
330660|NCT00302458|O5|Outcome|OROS-MPH+ IR-MPH|Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later
330661|NCT00302458|O4|Outcome|OROS-MPH+OROS-MPH|Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later
330891|NCT00303108|B3|Baseline|D+C+H|Doxil, Carboplatin, and Herceptin
331091|NCT00305448|E3|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
330662|NCT00302458|O3|Outcome|IR-MPH +IR-MPH|Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later
330663|NCT00302458|O2|Outcome|IR-MPH + OROS MPH|Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later
330664|NCT00302458|O1|Outcome|Placebo- Placebo|Healthy volunteers received a placebo, followed by a placebo four hours later
330665|NCT00302458|E1|Reported Event|Healthy Volunteers|Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
330666|NCT00302718|B5|Baseline|Total|Total of all reporting groups
330667|NCT00302718|B4|Baseline|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
330668|NCT00302718|B3|Baseline|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care
Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
330669|NCT00302718|B2|Baseline|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care
Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
330670|NCT00302718|B1|Baseline|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care
Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
331021|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
330671|NCT00302718|P4|Participant Flow|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
330672|NCT00302718|P3|Participant Flow|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care
Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
330673|NCT00302718|P2|Participant Flow|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care
Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
330674|NCT00302718|P1|Participant Flow|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care
Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
330675|NCT00302718|O2|Outcome|Intervention Group|This group is a combination of the physician and non-physician participants and the patients on the panels of the physician participants from the three intervention arms: physician-level, practice-level, and physician- and practice-level financial incentives.
330676|NCT00302718|O1|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
330677|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
330678|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care
Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
330679|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care
Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
330680|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care
Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
330681|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
330682|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care
Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
330683|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care
Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
330892|NCT00303108|B2|Baseline|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
330893|NCT00303108|B1|Baseline|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
330684|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care
Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
330685|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
330686|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care
Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
330687|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care
Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
330688|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care
Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
330689|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
330690|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care
Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
331052|NCT00305227|O2|Outcome|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
330691|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care
Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
330692|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care
Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
330693|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
330694|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care
Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
330695|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care
Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
330696|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care
Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
330697|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
330698|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care
Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
330699|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care
Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
330700|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care
Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
330701|NCT00302718|E4|Reported Event|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
330702|NCT00302718|E3|Reported Event|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care
Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
330894|NCT00303108|P3|Participant Flow|D+C+H|Doxil, Carboplatin, and Herceptin
330895|NCT00303108|P2|Participant Flow|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
330703|NCT00302718|E2|Reported Event|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care
Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
330704|NCT00302718|E1|Reported Event|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care
Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
330705|NCT00302848|B4|Baseline|Total|Total of all reporting groups
330706|NCT00302848|B3|Baseline|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
330707|NCT00302848|B2|Baseline|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
330708|NCT00302848|B1|Baseline|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
330709|NCT00302848|P3|Participant Flow|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
330710|NCT00302848|P2|Participant Flow|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
330711|NCT00302848|P1|Participant Flow|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
330712|NCT00302848|O2|Outcome|Users of LNG|Women who use authorized oral contraceptives containing LNG prescribed by their gynecologist
330713|NCT00302848|O1|Outcome|Users of DRSP|Women who use authorized oral contraceptives containing DRSP prescribed by their gynecologist
330714|NCT00302848|E3|Reported Event|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
330715|NCT00302848|E2|Reported Event|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
330716|NCT00302848|E1|Reported Event|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
330717|NCT00302952|B3|Baseline|Total|Total of all reporting groups
330780|NCT00294047|B2|Baseline|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
331193|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
330718|NCT00302952|B2|Baseline|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330719|NCT00302952|B1|Baseline|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330720|NCT00302952|P2|Participant Flow|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330721|NCT00302952|P1|Participant Flow|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330722|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330723|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330724|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330725|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330726|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330794|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330896|NCT00303108|P1|Participant Flow|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
330727|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330728|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330729|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330730|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330731|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330732|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330733|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
331051|NCT00305227|P1|Participant Flow|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
330734|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330735|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330736|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330737|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330738|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330739|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330740|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330741|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330742|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330743|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330744|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330745|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330746|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330747|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330748|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330749|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330781|NCT00294047|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330750|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330751|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330752|NCT00302952|E2|Reported Event|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
330753|NCT00302952|E1|Reported Event|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
330754|NCT00303069|B5|Baseline|Total|Total of all reporting groups
330755|NCT00303069|B4|Baseline|Placebo|Saline placebo single dose at baseline.
330756|NCT00303069|B3|Baseline|V710 90 μg|V710 90 μg single dose at baseline.
330757|NCT00303069|B2|Baseline|V710 30 μg|V710 30 μg single dose at baseline.
330758|NCT00303069|B1|Baseline|V710 5 μg|V710 5 μg single dose at baseline.
330759|NCT00303069|P4|Participant Flow|Placebo|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).
Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
330795|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330796|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330797|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330897|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
330760|NCT00303069|P3|Participant Flow|V710 90 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).
Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
330761|NCT00303069|P2|Participant Flow|V710 30 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).
Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
330762|NCT00303069|P1|Participant Flow|V710 5 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).
Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
330763|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
330764|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
330765|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
330766|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
330767|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
330768|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
330769|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
330770|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
330771|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
330772|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
330773|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
330774|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
330775|NCT00303069|E4|Reported Event|Placebo|Saline placebo single dose at baseline.
330776|NCT00303069|E3|Reported Event|V710 90 μg|V710 90 μg single dose at baseline.
330777|NCT00303069|E2|Reported Event|V710 30 μg|V710 30 μg single dose at baseline.
330778|NCT00303069|E1|Reported Event|V710 5 μg|V710 5 μg single dose at baseline.
330782|NCT00294047|P2|Participant Flow|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330783|NCT00294047|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330784|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330785|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330786|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330787|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330788|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330789|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330790|NCT00294047|O2|Outcome|Aluminium Hydroxide|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330791|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330792|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330793|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330886|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
330798|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330799|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330800|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330801|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330802|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330803|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330804|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330805|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330806|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330807|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330808|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330809|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330810|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330811|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330812|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330813|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330814|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330815|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330816|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330817|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330818|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330819|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330820|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330821|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330822|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330823|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330824|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330825|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330826|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330827|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330828|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330829|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330830|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330831|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330832|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330833|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330834|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330835|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330836|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330837|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330838|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330839|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330840|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330841|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330842|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330843|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330844|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330845|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330846|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330847|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330848|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330849|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330850|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330851|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330852|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330853|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330854|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330855|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330856|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330857|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330858|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330859|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330860|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330861|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330862|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330863|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330864|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330865|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330866|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330867|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330868|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330869|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330870|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330871|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330872|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330873|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330874|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330875|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330876|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330877|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330878|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330879|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330880|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330881|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330882|NCT00294047|E2|Reported Event|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330883|NCT00294047|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
330884|NCT00294060|B1|Baseline|Pacing Patients|Patients implanted with a pacemaker.
330885|NCT00294060|P1|Participant Flow|Pacing Patients|Patients implanted with a pacemaker.
330898|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
330899|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
330900|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
330901|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
330902|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
330903|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
330904|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
330905|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
330906|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
330907|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
330908|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
330909|NCT00303108|E2|Reported Event|D+C+H|Doxil, Carboplatin, and Herceptin
330910|NCT00303108|E1|Reported Event|D+C and Taxane Naive or Pretreated|Doxil, Carboplatin and Taxane naive or pretreated.
330911|NCT00303186|B1|Baseline|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330912|NCT00303186|P1|Participant Flow|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330913|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330914|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330915|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330916|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330917|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330918|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330919|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330920|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330921|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330922|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330923|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330924|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330925|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330926|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330927|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330928|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330929|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330930|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330931|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330932|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330933|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330934|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330935|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330936|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330937|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330938|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330939|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330940|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330941|NCT00303186|E1|Reported Event|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
330942|NCT00303316|B3|Baseline|Total|Total of all reporting groups
330943|NCT00303316|B2|Baseline|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330944|NCT00303316|B1|Baseline|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330945|NCT00303316|P2|Participant Flow|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330946|NCT00303316|P1|Participant Flow|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330947|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330948|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330949|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330950|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330951|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330952|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330953|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330984|NCT00304954|B2|Baseline|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
330954|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330955|NCT00303316|E2|Reported Event|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330956|NCT00303316|E1|Reported Event|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
330957|NCT00303329|B3|Baseline|Total|Total of all reporting groups
330958|NCT00303329|B2|Baseline|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
330959|NCT00303329|B1|Baseline|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
330960|NCT00303329|P2|Participant Flow|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
330961|NCT00303329|P1|Participant Flow|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
330962|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
330963|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
330964|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
330965|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
330966|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
330967|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
330968|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
330969|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
330970|NCT00303329|E2|Reported Event|Rare Anemias|Deferasirox (5-40 mg/kg/day)
330971|NCT00303329|E1|Reported Event|Beta-thalassemia|Deferasirox (5-40 mg/kg/day)
330972|NCT00304915|B3|Baseline|Total|Total of all reporting groups
330973|NCT00304915|B2|Baseline|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
330974|NCT00304915|B1|Baseline|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
330975|NCT00304915|P2|Participant Flow|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same 9-item Patient Health Questionnaire (PHQ-9) screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
330976|NCT00304915|P1|Participant Flow|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in VA electronic medical record. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
330977|NCT00304915|O2|Outcome|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
331087|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
331088|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
334057|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
330978|NCT00304915|O1|Outcome|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
330979|NCT00304915|E2|Reported Event|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
330980|NCT00304915|E1|Reported Event|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
330981|NCT00304954|B5|Baseline|Total|Total of all reporting groups
330982|NCT00304954|B4|Baseline|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
330983|NCT00304954|B3|Baseline|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
332913|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
330985|NCT00304954|B1|Baseline|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
330986|NCT00304954|P4|Participant Flow|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
330987|NCT00304954|P3|Participant Flow|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
330988|NCT00304954|P2|Participant Flow|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
330989|NCT00304954|P1|Participant Flow|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
330990|NCT00304954|O4|Outcome|Sixth-Month OCT - Fellow Eye|
330991|NCT00304954|O3|Outcome|Baseline OCT - Fellow Eye|
330992|NCT00304954|O2|Outcome|Sixth-Month OCT - Study Eye|
330993|NCT00304954|O1|Outcome|Baseline OCT - Study Eye|
330994|NCT00304954|O4|Outcome|Sixth-Month Vision - Fellow Eye|
330995|NCT00304954|O3|Outcome|Baseline Vision - Fellow Eye|
330996|NCT00304954|O2|Outcome|Sixth-Month Vision - Study Eye|
330997|NCT00304954|O1|Outcome|Baseline Vision - Study Eye|
330998|NCT00304954|O4|Outcome|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
330999|NCT00304954|O3|Outcome|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
331000|NCT00304954|O2|Outcome|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
331001|NCT00304954|O1|Outcome|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
331002|NCT00304954|E4|Reported Event|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
331003|NCT00304954|E3|Reported Event|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
331004|NCT00304954|E2|Reported Event|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
331005|NCT00304954|E1|Reported Event|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
331006|NCT00305162|B3|Baseline|Total|Total of all reporting groups
331007|NCT00305162|B2|Baseline|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331008|NCT00305162|B1|Baseline|Cangrelor Arm|cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
331009|NCT00305162|P2|Participant Flow|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion followed by placebo capsules post infusion
331010|NCT00305162|P1|Participant Flow|Cangrelor Arm|cangrelor arm: placebo capsules at PCI start + cangrelor bolus(30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
331011|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331089|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
331090|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
331012|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331013|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331014|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331015|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331016|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331017|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331018|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331019|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331020|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331022|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331023|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331024|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331025|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331026|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331027|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331028|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331029|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331030|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331031|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331032|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331033|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331034|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331035|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331036|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331037|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331038|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331039|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331040|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331041|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331042|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331043|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331044|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
331045|NCT00305162|E2|Reported Event|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
331046|NCT00305162|E1|Reported Event|Cangrelor Arm|cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
331047|NCT00305227|B3|Baseline|Total|Total of all reporting groups
331048|NCT00305227|B2|Baseline|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
331049|NCT00305227|B1|Baseline|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
331050|NCT00305227|P2|Participant Flow|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
331053|NCT00305227|O1|Outcome|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
331054|NCT00305227|E2|Reported Event|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
331055|NCT00305227|E1|Reported Event|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
331056|NCT00305253|B3|Baseline|Total|Total of all reporting groups
331057|NCT00305253|B2|Baseline|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
331058|NCT00305253|B1|Baseline|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
331059|NCT00305253|P2|Participant Flow|Post-Intervention|Post-intervention (NASG) period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol plus NASG.
331060|NCT00305253|P1|Participant Flow|Pre-Intervention|Pre-intervention period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol.
331061|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
331062|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
331063|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
331064|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
331065|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
331066|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
331067|NCT00305253|E2|Reported Event|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
331068|NCT00305253|E1|Reported Event|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
331069|NCT00305344|B1|Baseline|Cord Blood Recipient|Umbilical Cord Recipient
331070|NCT00305344|P1|Participant Flow|Cord Blood Recipient|Umbilical Cord Recipient
331071|NCT00305344|O1|Outcome|Recipients Receiving Cord Blood|Children with type 1 diabetes who underwent an autologous cord blood infusion
331072|NCT00305344|E1|Reported Event|Cord Blood Recipients|Children with type 1 diabetes who underwent an autologous cord blood infusion
331073|NCT00305448|B4|Baseline|Total|Total of all reporting groups
331074|NCT00305448|B3|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
331075|NCT00305448|B2|Baseline|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
331076|NCT00305448|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg
331077|NCT00305448|P3|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
331078|NCT00305448|P2|Participant Flow|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
331079|NCT00305448|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg
331080|NCT00305448|O1|Outcome|Fulvestrant|Fulvestrant
331081|NCT00305448|O1|Outcome|Fulvestrant|Fulvestrant
331082|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
331083|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
331084|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
331085|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
331086|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
331092|NCT00305448|E2|Reported Event|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
331093|NCT00305448|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg
331094|NCT00305565|B4|Baseline|Total|Total of all reporting groups
331095|NCT00305565|B3|Baseline|High Dose|Received output current 1.0-1.5 mA
331096|NCT00305565|B2|Baseline|Medium Dose|Received output current 0.5-1.0 mA
331097|NCT00305565|B1|Baseline|Low Dose|Received output current 0.25 mA
331098|NCT00305565|P3|Participant Flow|High Dose|Received output current 1.0-1.5 mA
331099|NCT00305565|P2|Participant Flow|Medium Dose|Received output current 0.5-1.0 mA
331100|NCT00305565|P1|Participant Flow|Low Dose|Received output current 0.25 milliamps (mA)
331101|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331102|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331103|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331104|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331105|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331106|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331107|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331108|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331109|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331110|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331111|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331112|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331113|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331114|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331115|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331116|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331117|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331118|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331119|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331120|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331121|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331122|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331123|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331124|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331125|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331126|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331127|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331128|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331129|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331130|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331131|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331132|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331133|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331134|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331135|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331136|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331137|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331138|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331139|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331140|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331141|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331142|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331143|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331144|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331145|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331146|NCT00305565|O1|Outcome|Log Dose-Response Regression Coefficient|All dosing groups
331147|NCT00305565|O1|Outcome|Log Dose-Response Regression Coefficient|All dosing groups
331148|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331149|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331150|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331151|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331152|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331153|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331154|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331155|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331156|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331157|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331158|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331159|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331160|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331161|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331162|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331163|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331164|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331165|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331166|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331167|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331168|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331169|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331170|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331171|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331172|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331173|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331174|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331175|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331176|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331177|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331178|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331179|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331180|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331181|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331182|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331183|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331184|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331185|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331186|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331187|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331188|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331189|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331190|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331191|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331192|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331194|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331195|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331196|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331197|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331198|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331199|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331200|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331201|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331202|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331203|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331204|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331205|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331206|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331207|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331208|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
331209|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
331210|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
331211|NCT00305565|E3|Reported Event|High Dose|Received output current 1.0-1.5 mA
331212|NCT00305565|E2|Reported Event|Medium Dose|Received output current 0.5-1.0 mA
331213|NCT00305565|E1|Reported Event|Low Dose|Received output current 0.25 mA
331214|NCT00305578|B3|Baseline|Total|Total of all reporting groups
331215|NCT00305578|B2|Baseline|Memantine|"Daily dose Memantine
Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
331216|NCT00305578|B1|Baseline|Placebo|"Placebo daily
Placebo : No active medication, only placebo"
331217|NCT00305578|P2|Participant Flow|Memantine|"Daily dose Memantine
Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
331218|NCT00305578|P1|Participant Flow|Placebo|"Placebo daily
Placebo : No active medication, only placebo"
331219|NCT00305578|O2|Outcome|Memantine|"Daily dose Memantine
Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
331220|NCT00305578|O1|Outcome|Placebo|"Placebo daily
Placebo : No active medication, only placebo"
331221|NCT00305578|E2|Reported Event|Memantine|"Daily dose Memantine
Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
331222|NCT00305578|E1|Reported Event|Placebo|"Placebo daily
Placebo : No active medication, only placebo"
331223|NCT00305604|B3|Baseline|Total|Total of all reporting groups
331224|NCT00305604|B2|Baseline|Placebo|Sitagliptin-matching placebo tablets.
331225|NCT00305604|B1|Baseline|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
331226|NCT00305604|P2|Participant Flow|Placebo|Sitagliptin-matching placebo tablets.
331227|NCT00305604|P1|Participant Flow|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
331228|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
331229|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
331230|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
331231|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
331232|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
331233|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
331234|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
331235|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
331236|NCT00305604|E2|Reported Event|Placebo|Sitagliptin-matching placebo tablets.
331237|NCT00305604|E1|Reported Event|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
331238|NCT00305643|B3|Baseline|Total|Total of all reporting groups
331239|NCT00305643|B2|Baseline|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
331240|NCT00305643|B1|Baseline|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
331241|NCT00305643|P2|Participant Flow|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
331531|NCT00306488|P2|Participant Flow|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
331242|NCT00305643|P1|Participant Flow|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
331243|NCT00305643|O2|Outcome|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
331244|NCT00305643|O1|Outcome|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
331245|NCT00305643|O2|Outcome|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
331246|NCT00305643|O1|Outcome|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
331247|NCT00305643|E2|Reported Event|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
331248|NCT00305643|E1|Reported Event|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
331249|NCT00305760|B1|Baseline|Group 1|
331250|NCT00305760|P1|Participant Flow|Group 1|
331251|NCT00305760|O1|Outcome|Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab|
331252|NCT00305760|E1|Reported Event|Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab|"Cetuximab: Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.
Pancreatic tumor vaccine: Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.
Cyclophosphamide: Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles."
331253|NCT00305773|B3|Baseline|Total|Total of all reporting groups
331254|NCT00305773|B2|Baseline|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331255|NCT00305773|B1|Baseline|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331256|NCT00305773|P2|Participant Flow|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331257|NCT00305773|P1|Participant Flow|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331258|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331259|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331260|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331261|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331262|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331263|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331264|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331511|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331265|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331266|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331267|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331268|NCT00305773|E2|Reported Event|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331269|NCT00305773|E1|Reported Event|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
331270|NCT00305864|B5|Baseline|Total|Total of all reporting groups
331271|NCT00305864|B4|Baseline|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331298|NCT00305877|E2|Reported Event|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
331681|NCT00306891|O1|Outcome|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
331272|NCT00305864|B3|Baseline|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331273|NCT00305864|B2|Baseline|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331274|NCT00305864|B1|Baseline|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331275|NCT00305864|P4|Participant Flow|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331276|NCT00305864|P3|Participant Flow|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331277|NCT00305864|P2|Participant Flow|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331278|NCT00305864|P1|Participant Flow|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331279|NCT00305864|O1|Outcome|All MGd 5mg/kg Patients (Phase I and II Arms Combined)|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331280|NCT00305864|O3|Outcome|Phase I: 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331281|NCT00305864|O2|Outcome|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331340|NCT00306202|O1|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
331282|NCT00305864|O1|Outcome|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331283|NCT00305864|E4|Reported Event|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331284|NCT00305864|E3|Reported Event|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331285|NCT00305864|E2|Reported Event|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331286|NCT00305864|E1|Reported Event|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
331287|NCT00305877|B3|Baseline|Total|Total of all reporting groups
331288|NCT00305877|B2|Baseline|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
331289|NCT00305877|B1|Baseline|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
331290|NCT00305877|P2|Participant Flow|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
331376|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331291|NCT00305877|P1|Participant Flow|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
331292|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
331293|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
331294|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
331295|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
331296|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
331297|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
331299|NCT00305877|E1|Reported Event|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
331300|NCT00305942|B1|Baseline|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
331301|NCT00305942|P1|Participant Flow|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
331302|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
331303|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
331304|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
331305|NCT00305942|E1|Reported Event|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
331306|NCT00306163|B3|Baseline|Total|Total of all reporting groups
331307|NCT00306163|B2|Baseline|Fluticasone|100 µg, twice daily
331308|NCT00306163|B1|Baseline|Ciclesonide|160 µg, once daily
331309|NCT00306163|P2|Participant Flow|Fluticasone|100 µg, twice daily
331310|NCT00306163|P1|Participant Flow|Ciclesonide|160 µg, once daily
331311|NCT00306163|O2|Outcome|Fluticasone|100 µg, twice daily
331312|NCT00306163|O1|Outcome|Ciclesonide|160 µg, once daily
331313|NCT00306163|E2|Reported Event|Fluticasone|100 µg, twice daily
331314|NCT00306163|E1|Reported Event|Ciclesonide|160 µg, once daily
331315|NCT00306189|B5|Baseline|Total|Total of all reporting groups
331316|NCT00306189|B4|Baseline|Placebo|
331317|NCT00306189|B3|Baseline|Denosumab 100 mg Q6M|
331318|NCT00306189|B2|Baseline|Denosumab 60 mg Q6M|
331319|NCT00306189|B1|Baseline|Denosumab 14 mg Q6M|
331320|NCT00306189|P4|Participant Flow|Placebo|
331321|NCT00306189|P3|Participant Flow|Denosumab 100 mg Q6M|
331322|NCT00306189|P2|Participant Flow|Denosumab 60 mg Q6M|
331323|NCT00306189|P1|Participant Flow|Denosumab 14 mg Q6M|
331324|NCT00306189|O4|Outcome|Denosumab 100 mg Q6M|
331325|NCT00306189|O3|Outcome|Denosumab 60 mg Q6M|
331326|NCT00306189|O2|Outcome|Denosumab 14 mg Q6M|
331327|NCT00306189|O1|Outcome|Placebo|
331328|NCT00306189|E4|Reported Event|Denosumab 100 mg Q6M|
331329|NCT00306189|E3|Reported Event|Denosumab 60 mg Q6M|
331330|NCT00306189|E2|Reported Event|Denosumab 14 mg Q6M|
331331|NCT00306189|E1|Reported Event|Placebo|
331332|NCT00306202|B4|Baseline|Total|Total of all reporting groups
331377|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331808|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331333|NCT00306202|B3|Baseline|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
331334|NCT00306202|B2|Baseline|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331335|NCT00306202|B1|Baseline|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
331336|NCT00306202|P3|Participant Flow|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
331337|NCT00306202|P2|Participant Flow|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331338|NCT00306202|P1|Participant Flow|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
331339|NCT00306202|O1|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
331361|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
333540|NCT00308737|O2|Outcome|Usual Care|Usual care
331341|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331342|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
331343|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
331344|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331345|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
331346|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
331347|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331348|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
331349|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
331350|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331414|NCT00306202|O3|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
331351|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
331352|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331353|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
331354|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
331355|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
331356|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331357|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331358|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
331359|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
331360|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331362|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
331363|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
331364|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331365|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331366|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
331367|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
331368|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331369|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331370|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
331371|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
331372|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331373|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331374|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
331375|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
331415|NCT00306202|O2|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
331378|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
331379|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
331380|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331381|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331382|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
331383|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
331384|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331385|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331386|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
331387|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
331423|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
331388|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331389|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331390|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.
Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
331391|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.
Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
331392|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.
Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
331393|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.
Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).
Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
331394|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.
Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
331395|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
331809|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331396|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331397|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331398|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2.
QD, as long as clinical benefit was maintained."
331399|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331400|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331401|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331402|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331424|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
331403|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331404|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331405|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331406|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331407|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331408|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331409|NCT00306202|O1|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331410|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
331411|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
331412|NCT00306202|O1|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
331413|NCT00306202|O4|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
331416|NCT00306202|O1|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331417|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331418|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331419|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331420|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331421|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331422|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331682|NCT00306891|E3|Reported Event|Cediranib 30 - 90 mg Dose Escalation|Cediranib 30 - 90 mg Dose Escalation
331425|NCT00306202|O4|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
331426|NCT00306202|O3|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331427|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331428|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331429|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331430|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331431|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331432|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 1 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331433|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331434|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331435|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331436|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331437|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331438|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331439|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331440|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331441|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Ph+ chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331442|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331443|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331527|NCT00306384|E3|Reported Event|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331683|NCT00306891|E2|Reported Event|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
331444|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331445|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Ph+ chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331446|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331447|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
331448|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
331449|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
331450|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331451|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331452|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331453|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 80 mg/m^2, as long as clinical benefit was maintained."
331454|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331455|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
331456|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
331457|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
331458|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331482|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331512|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331459|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331460|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331461|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 80 mg/m^2, as long as clinical benefit was maintained."
331462|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331463|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
331464|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
331465|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
331466|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331467|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331528|NCT00306384|E2|Reported Event|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331529|NCT00306384|E1|Reported Event|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331468|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331469|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331470|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331471|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
331472|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
331473|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
331474|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
331475|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331476|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331477|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331478|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331479|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
331480|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
331481|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
331804|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331483|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331484|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331485|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
331486|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
331487|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2, escalated/dose level 3 of 100 mg/m^2, escalated/dose level 3 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
331488|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331489|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
331490|NCT00306202|E3|Reported Event|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
331530|NCT00306488|B1|Baseline|Participant Information|
331491|NCT00306202|E2|Reported Event|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).
Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
331492|NCT00306202|E1|Reported Event|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
331493|NCT00306384|B4|Baseline|Total|Total of all reporting groups
331494|NCT00306384|B3|Baseline|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331495|NCT00306384|B2|Baseline|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331496|NCT00306384|B1|Baseline|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331497|NCT00306384|P3|Participant Flow|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331498|NCT00306384|P2|Participant Flow|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331499|NCT00306384|P1|Participant Flow|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331500|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331501|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331502|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331503|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331504|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331505|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331506|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331507|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331508|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331509|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331510|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331513|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331514|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331515|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331516|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331517|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331518|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331519|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331520|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331521|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331522|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331523|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331524|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
331525|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
331526|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
331532|NCT00306488|P1|Participant Flow|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
331533|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
331534|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
331535|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
331536|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
331537|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
331538|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
331539|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
331540|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
331541|NCT00306488|E1|Reported Event|Participant Adverse Event Information|
331542|NCT00306527|B5|Baseline|Total|Total of all reporting groups
331543|NCT00306527|B4|Baseline|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
331544|NCT00306527|B3|Baseline|Adults (cTIV\TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
331545|NCT00306527|B2|Baseline|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.
331546|NCT00306527|B1|Baseline|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.
331547|NCT00306527|P4|Participant Flow|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61years) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
331548|NCT00306527|P3|Participant Flow|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61years of age ) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
331549|NCT00306527|P2|Participant Flow|Adults (cTIV\TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
331550|NCT00306527|P1|Participant Flow|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
331551|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331552|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331553|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331554|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331555|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331556|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
331557|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331558|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
331559|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331560|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331561|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331562|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331563|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331564|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
333541|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
331565|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331566|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
331567|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331568|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331569|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331570|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331571|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331572|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
331573|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331574|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
331575|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331576|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331577|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331578|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331579|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331580|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
331581|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331582|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
331805|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331583|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331584|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331585|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331586|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331587|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331588|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
331589|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331590|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
331591|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331592|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331593|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
331684|NCT00306891|E1|Reported Event|Cediranib 45 mg Part A|Part A: Cediranib 45 mg
331685|NCT00306917|B3|Baseline|Total|Total of all reporting groups
331594|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331595|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331596|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
331597|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
331598|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
331599|NCT00306527|E4|Reported Event|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
331600|NCT00306527|E3|Reported Event|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
331601|NCT00306527|E2|Reported Event|Adults (cTIV/TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
331602|NCT00306527|E1|Reported Event|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
331603|NCT00306592|B1|Baseline|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
331604|NCT00306592|P2|Participant Flow|Natalizumab Study 101-MS-321 (NCT00297232)|Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 268 weeks. (Week 52 through Week 480 of Study 101-MS-321 (NCT00297232) is considered to be the Long-Term Treatment Period).
331605|NCT00306592|P1|Participant Flow|Natalizumab Study 101-MS-322 (NCT00306592)|Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
331606|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
331607|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
331608|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
331609|NCT00306592|E1|Reported Event|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
331610|NCT00306670|B3|Baseline|Total|Total of all reporting groups
331611|NCT00306670|B2|Baseline|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.
prednisone: <30 mg/day"
331612|NCT00306670|B1|Baseline|Rituximab|"Patients will receive rituximab.
Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies
prednisone: <30 mg/day"
331613|NCT00306670|P2|Participant Flow|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.
prednisone: <30 mg/day"
331614|NCT00306670|P1|Participant Flow|Rituximab|"Patients will receive rituximab.
Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies
prednisone: <30 mg/day"
331615|NCT00306670|O2|Outcome|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.
prednisone: <30 mg/day"
331616|NCT00306670|O1|Outcome|Rituximab|"Patients will receive rituximab.
Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies
prednisone: <30 mg/day"
331617|NCT00306670|E2|Reported Event|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.
prednisone: <30 mg/day"
331618|NCT00306670|E1|Reported Event|Rituximab|"Patients will receive rituximab.
Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies
prednisone: <30 mg/day"
331619|NCT00306787|B3|Baseline|Total|Total of all reporting groups
331620|NCT00306787|B2|Baseline|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
331621|NCT00306787|B1|Baseline|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
331622|NCT00306787|P2|Participant Flow|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
331623|NCT00306787|P1|Participant Flow|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
331624|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
331625|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
331626|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
331627|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
331628|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
331629|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
331630|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
331631|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
331632|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
331633|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
331634|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
331635|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
331636|NCT00306787|E2|Reported Event|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
331637|NCT00306787|E1|Reported Event|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
331638|NCT00306852|B3|Baseline|Total|Total of all reporting groups
331639|NCT00306852|B2|Baseline|Implant|"Baerveldt Implant
Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
331757|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331640|NCT00306852|B1|Baseline|Trabeculectomy|"Trabeculectomy with mitomycin C
Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
331641|NCT00306852|P2|Participant Flow|Implant|"Baerveldt Implant
Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
331642|NCT00306852|P1|Participant Flow|Trabeculectomy|"Trabeculectomy with mitomycin C
Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
331643|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant
Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
331644|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C
Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
331645|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant
Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
331646|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C
Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
331647|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant
Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
331648|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C
Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
331649|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant
Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
331650|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C
Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
331651|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant
Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
331652|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C
Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
331653|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant
Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
331654|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C
Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
331655|NCT00306852|E2|Reported Event|Implant|"Baerveldt Implant
Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
331806|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331807|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331656|NCT00306852|E1|Reported Event|Trabeculectomy|"Trabeculectomy with mitomycin C
Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
331657|NCT00306891|B5|Baseline|Total|Total of all reporting groups
331658|NCT00306891|B4|Baseline|Cediranib 30 to 90 mg Dose Escalation|Part B: Cediranib Dose Escalation
331659|NCT00306891|B3|Baseline|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
331660|NCT00306891|B2|Baseline|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
331661|NCT00306891|B1|Baseline|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
331662|NCT00306891|P4|Participant Flow|Cediranib 30 to 90 mg Dose Escalation|Part B: Cediranib Dose Escalation
331663|NCT00306891|P3|Participant Flow|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
331664|NCT00306891|P2|Participant Flow|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
331665|NCT00306891|P1|Participant Flow|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
331666|NCT00306891|O2|Outcome|Arm 4 - Cediranib 30-90 mg Dose Escalation|Part B: Cediranib 30-90 mg Dose Escalation
331667|NCT00306891|O1|Outcome|Arm 3 - Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
331668|NCT00306891|O2|Outcome|Arm 4 - Cediranib 30-90 mg Dose Escalation|Part B: Cediranib 30-90 mg Dose Escalation
331669|NCT00306891|O1|Outcome|Arm 3 - Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
331670|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
331671|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
331672|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
331673|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
331674|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
331675|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
331676|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
331677|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
331678|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
331679|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
331680|NCT00306891|O2|Outcome|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
331686|NCT00306917|B2|Baseline|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
331687|NCT00306917|B1|Baseline|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
331688|NCT00306917|P2|Participant Flow|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
331689|NCT00306917|P1|Participant Flow|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
331690|NCT00306917|O2|Outcome|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
331691|NCT00306917|O1|Outcome|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
331692|NCT00306917|E2|Reported Event|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
331693|NCT00306917|E1|Reported Event|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
331694|NCT00307034|B3|Baseline|Total|Total of all reporting groups
331695|NCT00307034|B2|Baseline|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331696|NCT00307034|B1|Baseline|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331697|NCT00307034|P2|Participant Flow|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331758|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331698|NCT00307034|P1|Participant Flow|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331699|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331700|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331701|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331702|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331703|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331704|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331705|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331706|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331707|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331759|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331760|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331761|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331708|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331709|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331710|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331711|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331712|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331713|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331714|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331715|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331716|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331717|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331762|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331763|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
339164|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
331718|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331719|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331720|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331721|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331722|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331723|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331724|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331725|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331726|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331727|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331764|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331765|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
339165|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
331728|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331729|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331730|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331731|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331732|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331733|NCT00307034|E2|Reported Event|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331734|NCT00307034|E1|Reported Event|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
331735|NCT00307047|B3|Baseline|Total|Total of all reporting groups
331736|NCT00307047|B2|Baseline|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331737|NCT00307047|B1|Baseline|XIENCE V®|Patients recieving the XIENCE V® stent
331738|NCT00307047|P2|Participant Flow|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331739|NCT00307047|P1|Participant Flow|XIENCE V®|Patients recieving the XIENCE V® stent
331740|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331741|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331742|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331743|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331744|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331745|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331746|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331747|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331748|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331749|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331750|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331751|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331752|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331753|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331754|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331755|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331756|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
339166|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
331766|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331767|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331768|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331769|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331770|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331771|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331772|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331773|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331774|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331775|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331776|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331777|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331778|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331779|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331780|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331781|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331782|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331783|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331784|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331785|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331786|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331787|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331788|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331789|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331790|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331791|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331792|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331793|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331794|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331795|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331796|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331797|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331798|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331799|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331800|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331801|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331802|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331803|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331810|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331811|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331812|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331813|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331814|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331815|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331816|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331817|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331818|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331819|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331820|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331821|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331822|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331823|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331824|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331825|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331826|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331827|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331828|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331829|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331830|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331831|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331832|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331833|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331834|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331835|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331836|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331837|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331838|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331839|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331840|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331841|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331842|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331843|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331844|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331845|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331846|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331847|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331848|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331849|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331850|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331851|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331852|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331853|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331854|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331855|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331856|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331857|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331858|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331859|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331860|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331861|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331862|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331863|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331864|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331865|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331866|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331867|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331868|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331869|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331870|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331871|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
331872|NCT00307047|E2|Reported Event|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
331873|NCT00307047|E1|Reported Event|XIENCE V®|Patients recieving the XIENCE V® stent
331895|NCT00307125|O1|Outcome|Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects ≤18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
332067|NCT00297427|B2|Baseline|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
331874|NCT00307086|B1|Baseline|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant
Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant
PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)
Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
331875|NCT00307086|P1|Participant Flow|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant
Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant
PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)
Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
331876|NCT00307086|O1|Outcome|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant
Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant
PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)
Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
331877|NCT00307086|E1|Reported Event|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant
Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant
PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)
Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
331878|NCT00307125|B3|Baseline|Total|Total of all reporting groups
331879|NCT00307125|B2|Baseline|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331880|NCT00307125|B1|Baseline|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331908|NCT00307151|B1|Baseline|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331881|NCT00307125|P3|Participant Flow|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331882|NCT00307125|P2|Participant Flow|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331883|NCT00307125|P1|Participant Flow|Screening Phase|Kidney (renal) transplant recipients with no detectable anti-human leukocyte antigen (HLA) antibodies prior to transplant. Participants were screened for the development of anti-HLA antibodies once every 3 months up to 36 months post-transplantation and yearly thereafter until Month 60.
331884|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331885|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331886|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331887|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331888|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331889|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331890|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331891|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331892|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331893|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331894|NCT00307125|O2|Outcome|Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject ≤18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression is site-specific."
331896|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331897|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331898|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331899|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331900|NCT00307125|O1|Outcome|Screening Phase|Participants who were analyzed during the screening phase of the study
331901|NCT00307125|O1|Outcome|Screening Phase|Participants who were analyzed during the screening phase/stage of the study
331902|NCT00307125|E2|Reported Event|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331903|NCT00307125|E1|Reported Event|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
Standard immunosuppression was site-specific."
331904|NCT00307151|B5|Baseline|Total|Total of all reporting groups
331905|NCT00307151|B4|Baseline|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
331906|NCT00307151|B3|Baseline|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
331907|NCT00307151|B2|Baseline|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331909|NCT00307151|P4|Participant Flow|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
331910|NCT00307151|P3|Participant Flow|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
331911|NCT00307151|P2|Participant Flow|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331912|NCT00307151|P1|Participant Flow|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331913|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
331914|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
331915|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331916|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331917|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
331918|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
331919|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331920|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331921|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
331922|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
331923|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331924|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331925|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
331926|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
331927|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331928|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331929|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
331930|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
331931|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331932|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331933|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
331934|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
331935|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331936|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331937|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
331938|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
331939|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331940|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331941|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
331942|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
331943|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331944|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331945|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
331946|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
331947|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331948|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331949|NCT00307151|E4|Reported Event|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen.
331950|NCT00307151|E3|Reported Event|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen.
331951|NCT00307151|E2|Reported Event|Coh I: LPV/r|Cohort II: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
331952|NCT00307151|E1|Reported Event|Coh I: NVP|Cohort II: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
331953|NCT00307164|B3|Baseline|Total|Total of all reporting groups
331954|NCT00307164|B2|Baseline|Placebo|Participants received NucleomaxX placebo through week 48
331955|NCT00307164|B1|Baseline|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331956|NCT00307164|P2|Participant Flow|Placebo|Participants received NucleomaxX placebo through week 48
331957|NCT00307164|P1|Participant Flow|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331958|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331959|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331960|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331961|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331962|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331963|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331964|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331965|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331966|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331967|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331968|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331969|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331970|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331971|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331972|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331973|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331974|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331975|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331976|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331977|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331978|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331979|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331980|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331981|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331982|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331983|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331984|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331985|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331986|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331987|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331988|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
331989|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331990|NCT00307164|E2|Reported Event|Placebo|Participants received NucleomaxX placebo through week 48
331991|NCT00307164|E1|Reported Event|NucleomaxX|Participants received NucleomaxX for uridine through week 48
331992|NCT00307294|B1|Baseline|Thalidomide and Doxil|"Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
331993|NCT00307294|P1|Participant Flow|Thalidomide and Doxil|"Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
332062|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
331994|NCT00307294|O1|Outcome|Thalidomide and Doxil|"Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
331995|NCT00307294|E1|Reported Event|Thalidomide and Doxil|"Combination of Thalidomide and Doxil
Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
331996|NCT00297115|B3|Baseline|Total|Total of all reporting groups
331997|NCT00297115|B2|Baseline|Placebo|once daily
331998|NCT00297115|B1|Baseline|Roflumilast|500 mcg, once daily, oral administration in the morning
331999|NCT00297115|P2|Participant Flow|Placebo|once daily
332000|NCT00297115|P1|Participant Flow|Roflumilast|500 mcg, once daily, oral administration in the morning
332001|NCT00297115|O2|Outcome|Placebo|once daily
332002|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
332003|NCT00297115|O2|Outcome|Placebo|once daily
332004|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
332005|NCT00297115|O2|Outcome|Placebo|once daily
332006|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
332007|NCT00297115|O2|Outcome|Placebo|once daily
332008|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
332009|NCT00297115|O2|Outcome|Placebo|once daily
332010|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
332011|NCT00297115|O2|Outcome|Placebo|once daily
332012|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
332013|NCT00297115|E2|Reported Event|Placebo|once daily
332014|NCT00297115|E1|Reported Event|Roflumilast|500 mcg, once daily, oral administration in the morning
332015|NCT00297167|B1|Baseline|Entire Study Population|Includes participants who received EUR-1008 (APT-1008) in open-label dose titration and stabilization phase; and EUR-1008 (APT-1008) first and placebo first after randomization to study treatment.
332092|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332093|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
332094|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332016|NCT00297167|P3|Participant Flow|EUR-1008 (APT-1008) (Open-label)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily at a fixed stabilized dose during open-label normalization period 1 (5 to 14 days) after first double-blind interventional period and during open-label normalization period 2 (7 days) after second double-blind interventional period.
332017|NCT00297167|P2|Participant Flow|EUR-1008 (APT-1008) First, Then Placebo|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first double-blind intervention period followed by placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
332018|NCT00297167|P1|Participant Flow|Placebo First, Then EUR-1008 (APT-1008)|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first double-blind intervention period followed by EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (lipase units/kg/day).
332019|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
332020|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
332021|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
332022|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
332063|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
332068|NCT00297427|B1|Baseline|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
332023|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
332024|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
332025|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
332026|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
332027|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
332095|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
332096|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332097|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
332098|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture twice weekly for 6 weeks
332028|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
332029|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
332030|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
332031|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
332032|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
332033|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
332034|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
332064|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
332065|NCT00297258|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
332066|NCT00297427|B3|Baseline|Total|Total of all reporting groups
332035|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
332036|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
332037|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
332038|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
332039|NCT00297167|E2|Reported Event|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
332099|NCT00297427|O1|Outcome|True Acupuncture|True Acupuncture twice weekly for 6 weeks.
332100|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332101|NCT00297427|O1|Outcome|Acupuncture|Ture acupuncture twice a week for 6 weeks
332102|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332103|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
332104|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332105|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
339167|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
332040|NCT00297167|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. Participants received EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily at a fixed stabilized dose for 5 to 14 days during open-label dose normalization period 1 and for 7 days during open-label dose normalization period 2 which was maintained after each double-blind intervention period. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (units/kg/day).
332041|NCT00297232|B1|Baseline|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
332042|NCT00297232|P1|Participant Flow|Natalizumab|300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
332043|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
332044|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
332045|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
332046|NCT00297232|E1|Reported Event|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
332047|NCT00297258|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
332048|NCT00297258|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
332049|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
332050|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
332051|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
332052|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
332053|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
332054|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
332055|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
332056|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
332057|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
332058|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
332059|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
332060|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
332061|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
332069|NCT00297427|P2|Participant Flow|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332070|NCT00297427|P1|Participant Flow|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
332071|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332072|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
332073|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332074|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
332075|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
332076|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
332077|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332078|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
332079|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture twice a week for 6 weeks
332080|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: True acupuncture twice weekly for 6 weeks
332081|NCT00297427|O2|Outcome|Non-responders|Less than a 50% reduction in incontinent episodes following true acupuncture
332082|NCT00297427|O1|Outcome|Responders|50% or greater reduction in incontinent episodes following true acupuncture
332083|NCT00297427|O2|Outcome|Non-responders|Less than a 50% reduction in incontinent episodes following true acupuncture
332084|NCT00297427|O1|Outcome|Responders|50% or greater reduction in incontinent episodes following true acupuncture
332085|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332086|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
332087|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332088|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
332089|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332090|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
332091|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
332168|NCT00298272|B3|Baseline|Total|Total of all reporting groups
332106|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332107|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
332108|NCT00297427|E2|Reported Event|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
332109|NCT00297427|E1|Reported Event|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
332110|NCT00297492|B4|Baseline|Total|Total of all reporting groups
332111|NCT00297492|B3|Baseline|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
332112|NCT00297492|B2|Baseline|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
332113|NCT00297492|B1|Baseline|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
332114|NCT00297492|P3|Participant Flow|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
332115|NCT00297492|P2|Participant Flow|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
332116|NCT00297492|P1|Participant Flow|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
332117|NCT00297492|O3|Outcome|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office; nicotine lozenges were provided for use starting on the quit date.
332118|NCT00297492|O2|Outcome|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date; nicotine lozenges were provided for use starting on the quit date.
332119|NCT00297492|O1|Outcome|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date; nicotine lozenges were provided to aid reduction prior to the quit date and for use on and following the quit date.
332120|NCT00297492|E3|Reported Event|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
332121|NCT00297492|E2|Reported Event|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
332122|NCT00297492|E1|Reported Event|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
332123|NCT00297596|B1|Baseline|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
332124|NCT00297596|P1|Participant Flow|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
332149|NCT00298233|B1|Baseline|Standarad Dose Oseltamivir|All participants that were randomized and received standard dose oseltamivir
332150|NCT00298233|P4|Participant Flow|Double Dose Oseltamivir Child Cohort|All Participants <15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
332240|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332125|NCT00297596|O1|Outcome|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
332126|NCT00297596|E1|Reported Event|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
332127|NCT00298090|B1|Baseline|StO2 Values|StO2 values pre and post arterial line placement.
332128|NCT00298090|P1|Participant Flow|StO2 Values Pre and Post Arterial Line Placement|single arm study of StO2 in subjects undergoing placement of arterial line. Measurements of StO2 will be taken before and after arterial line placement.
332129|NCT00298090|O1|Outcome|StO2 Values|StO2 pre and post catheter placement
332130|NCT00298090|E1|Reported Event|StO2|StO2 measurements pre and post arterial line catheter placement.
332131|NCT00298155|B4|Baseline|Total|Total of all reporting groups
332132|NCT00298155|B3|Baseline|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks
goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
332133|NCT00298155|B2|Baseline|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks
goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
332134|NCT00298155|B1|Baseline|Group 1|"Goserelin + dutasteride
goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
332978|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
332135|NCT00298155|P3|Participant Flow|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks
goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
332136|NCT00298155|P2|Participant Flow|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks
goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
332137|NCT00298155|P1|Participant Flow|Group 1|"Goserelin + dutasteride
goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
332138|NCT00298155|O3|Outcome|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks
goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
332139|NCT00298155|O2|Outcome|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks
goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
332140|NCT00298155|O1|Outcome|Group 1|"Goserelin + dutasteride
goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
332141|NCT00298155|O3|Outcome|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks
goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
332142|NCT00298155|O2|Outcome|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks
goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
332143|NCT00298155|O1|Outcome|Group 1|"Goserelin + dutasteride
goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
332144|NCT00298155|E3|Reported Event|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks
goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
332145|NCT00298155|E2|Reported Event|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks
goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
332146|NCT00298155|E1|Reported Event|Group 1|"Goserelin + dutasteride
goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
332147|NCT00298233|B3|Baseline|Total|Total of all reporting groups
332148|NCT00298233|B2|Baseline|Double Dose Oseltamivir|All participants that were randomized and received doubledose oseltamivir
332151|NCT00298233|P3|Participant Flow|Standard Dose Oseltamivir Child Cohort|All participants <15 years received standard dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
332152|NCT00298233|P2|Participant Flow|Double Dose Oseltamivir Adult Cohort|All Participants >= 15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
332153|NCT00298233|P1|Participant Flow|Standard Dose Oseltamivir Adult Cohort|All participants >= 15 years received standard-dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
332154|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
332155|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
332156|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
332157|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
332158|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
332159|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
332160|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
332161|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
332162|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
332163|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
332164|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
332165|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
332166|NCT00298233|E2|Reported Event|Standard Dose Oseltamivir|The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events.
332167|NCT00298233|E1|Reported Event|Double Dose Oseltamivir|The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events.
332169|NCT00298272|B2|Baseline|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332170|NCT00298272|B1|Baseline|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332171|NCT00298272|P2|Participant Flow|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332172|NCT00298272|P1|Participant Flow|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332173|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332174|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332175|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332196|NCT00298363|P3|Participant Flow|Entecavir|Participants in this group were randomized to receive DB ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
332241|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332176|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332177|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332178|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332179|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332180|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
332181|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
332213|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332182|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
332183|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
332184|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
332185|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
332186|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
332187|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
332188|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
332189|NCT00298272|E3|Reported Event|Cumulative Rituximab|The cumulative rituximab treatment group included all participants who received rituximab at any time during the study, including participants who received rituximab in the double-blind period and did not participate in the OL period, those who received placebo in the double-blind period and rituximab in the OL, and those who received rituximab in the double-blind and OL periods. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
332190|NCT00298272|E2|Reported Event|Double-Blind Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
332191|NCT00298272|E1|Reported Event|Double-Blind Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
332192|NCT00298363|B4|Baseline|Total|Total of all reporting groups
332193|NCT00298363|B3|Baseline|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332194|NCT00298363|B2|Baseline|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332195|NCT00298363|B1|Baseline|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332370|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
332197|NCT00298363|P2|Participant Flow|FTC/TDF|Participants in this group were randomized to receive DB FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
332198|NCT00298363|P1|Participant Flow|Tenofovir DF|Participants in this group were randomized to receive double-blind (DB) TDF 300 mg + FTC)/TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to open-label (OL) FTC/TDF (this study enrolled participants with decompensated liver disease, and early intervention strategies were provided if profound viral suppression was not achieved quickly).
332199|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332200|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332201|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332202|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332203|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332204|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332205|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332206|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332207|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332208|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332209|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332210|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332211|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332212|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332979|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
332214|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332215|NCT00298363|O4|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332216|NCT00298363|O3|Outcome|TDF or FTC/TDF|Participants in this group include all participants who received TDF or FTC/TDF during the study.
332217|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332218|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332219|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332220|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332221|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332222|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332223|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332224|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332225|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332226|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332227|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332228|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332229|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332230|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332231|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332232|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332233|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332234|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332235|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332236|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332237|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332238|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332239|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332242|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332243|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332244|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332245|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332246|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332247|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332248|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332249|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332250|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332251|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332252|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332253|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332254|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332255|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332256|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332257|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332258|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332848|NCT00300430|P1|Participant Flow|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332259|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332260|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332261|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332262|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332263|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332264|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332265|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332266|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332267|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332268|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332269|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332270|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332271|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332272|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332273|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332274|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332275|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332276|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332277|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332278|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332279|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332280|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332281|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332282|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332283|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332284|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332285|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332286|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332287|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332288|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332289|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332290|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332291|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332292|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332293|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332294|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332295|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332296|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332297|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332298|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332299|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332300|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332301|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332302|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332303|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332304|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332305|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332306|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332307|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332308|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332309|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332310|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332311|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332312|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332313|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332314|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332315|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332316|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332317|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332318|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332319|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332320|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332321|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332322|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332323|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332324|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332325|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332326|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332327|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332328|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332329|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332330|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332331|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332332|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332333|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332334|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332335|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332336|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332337|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332338|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332339|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332340|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
332341|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332342|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332343|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332344|NCT00298363|O4|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
332345|NCT00298363|O3|Outcome|TDF or FTC/TDF|Participants in this group include all participants who received TDF or FTC/TDF during the study.
332346|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
332347|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
332348|NCT00298363|E5|Reported Event|All TDF|Participants in this group received a TDF-containing treatment (all double-blind TDF, FTC/TDF, or open-label FTC/TDF) during the study.
332349|NCT00298363|E4|Reported Event|Open Label FTC/TDF|Participants in this group were randomized to receive TDF, FTC/TDF, or ETV at the beginning of the study, but switched to open label FTC/TDF during the study.
332980|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332350|NCT00298363|E3|Reported Event|Double Blind ETV|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo
332351|NCT00298363|E2|Reported Event|Double Blind FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo
332352|NCT00298363|E1|Reported Event|Double Blind TDF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo
332353|NCT00298558|B5|Baseline|Total|Total of all reporting groups
332354|NCT00298558|B4|Baseline|Control|This group did not complete any cognitive training interventions
332355|NCT00298558|B3|Baseline|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
332356|NCT00298558|B2|Baseline|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
332357|NCT00298558|B1|Baseline|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
332358|NCT00298558|P4|Participant Flow|Control|This group did not complete any cognitive training interventions
332359|NCT00298558|P3|Participant Flow|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
332360|NCT00298558|P2|Participant Flow|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
332361|NCT00298558|P1|Participant Flow|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
332362|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
332363|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
332364|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
332365|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
332366|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
332367|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
332368|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
332369|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
332371|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
332372|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
332373|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
332374|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
332375|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
332376|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
332377|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
332378|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
332379|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
332380|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
332381|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
332382|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
333045|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
332383|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
332384|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
332385|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
332386|NCT00298558|E4|Reported Event|Control|This group did not complete any cognitive training interventions
332387|NCT00298558|E3|Reported Event|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
332388|NCT00298558|E2|Reported Event|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
332389|NCT00298558|E1|Reported Event|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
332390|NCT00298610|B1|Baseline|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
332391|NCT00298610|P1|Participant Flow|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
332392|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
332393|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
332394|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
332395|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
332705|NCT00299702|P1|Participant Flow|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
332706|NCT00299702|O2|Outcome|Abilify|10-30 mg once daily oral for 104 weeks
332396|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
332397|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
332398|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
332399|NCT00298610|E1|Reported Event|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
332400|NCT00298766|B1|Baseline|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
332401|NCT00298766|P1|Participant Flow|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
332402|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
332403|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
332404|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
332405|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
332849|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332406|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
332407|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
332408|NCT00298766|E1|Reported Event|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
332409|NCT00299000|B3|Baseline|Total|Total of all reporting groups
332410|NCT00299000|B2|Baseline|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
332411|NCT00299000|B1|Baseline|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
332412|NCT00299000|P2|Participant Flow|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
332413|NCT00299000|P1|Participant Flow|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
332414|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
332415|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
332416|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
332417|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
332418|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
332419|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
332420|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
332421|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
332422|NCT00299000|E2|Reported Event|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
332423|NCT00299000|E1|Reported Event|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
332424|NCT00299104|B4|Baseline|Total|Total of all reporting groups
332425|NCT00299104|B3|Baseline|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332426|NCT00299104|B2|Baseline|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332427|NCT00299104|B1|Baseline|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332428|NCT00299104|P3|Participant Flow|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332707|NCT00299702|O1|Outcome|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
332429|NCT00299104|P2|Participant Flow|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332430|NCT00299104|P1|Participant Flow|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332431|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332432|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332433|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332434|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332435|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332436|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332437|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332438|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332439|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332440|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332441|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332442|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332443|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332444|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332675|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
332445|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332446|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332447|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332448|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332449|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332450|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332451|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332484|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
333267|NCT00308139|O3|Outcome|All Treatment|
332452|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332453|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332454|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332455|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332456|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332457|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332458|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332459|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332460|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332461|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332462|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332463|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332464|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332465|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332466|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332467|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332655|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
332468|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332469|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332470|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332471|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332472|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332473|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332474|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332475|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332476|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332477|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332478|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332479|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332480|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332481|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332482|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332483|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332656|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
332485|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332486|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332487|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332488|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332489|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332490|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332491|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332492|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332493|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332494|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332495|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332496|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332497|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332498|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332499|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332500|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332657|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
332501|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332502|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332503|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332504|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332505|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332506|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332507|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332508|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332509|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332510|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332511|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332512|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332513|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332514|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332515|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332516|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332658|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
332517|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332518|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332519|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332520|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332521|NCT00299104|E3|Reported Event|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332522|NCT00299104|E2|Reported Event|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
332523|NCT00299104|E1|Reported Event|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.
From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
332524|NCT00299130|B4|Baseline|Total|Total of all reporting groups
332525|NCT00299130|B3|Baseline|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332702|NCT00299702|B2|Baseline|Abilify|10-30 mg once daily oral for 104 weeks
332703|NCT00299702|B1|Baseline|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
332526|NCT00299130|B2|Baseline|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332527|NCT00299130|B1|Baseline|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332528|NCT00299130|P3|Participant Flow|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332529|NCT00299130|P2|Participant Flow|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332530|NCT00299130|P1|Participant Flow|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332659|NCT00299221|E2|Reported Event|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
332660|NCT00299221|E1|Reported Event|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
332531|NCT00299130|O1|Outcome|Rituximab + MTX|"Participants received 0.5 g or 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332532|NCT00299130|O2|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332533|NCT00299130|O1|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332534|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332535|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332536|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332537|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332538|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332539|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332540|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332541|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332661|NCT00299416|B1|Baseline|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
332662|NCT00299416|P1|Participant Flow|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
332542|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332543|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332544|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332545|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332546|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332547|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332548|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332549|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332550|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332551|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332552|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332575|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332553|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332554|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332555|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332556|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332557|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332558|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332559|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332560|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332561|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332562|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332563|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332587|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332564|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332565|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332566|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332567|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332568|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332569|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332570|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332571|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332572|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332573|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332574|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332645|NCT00299221|B2|Baseline|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
332646|NCT00299221|B1|Baseline|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
332576|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332577|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332578|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332579|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332580|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332581|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332582|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332583|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332584|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332585|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332586|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332647|NCT00299221|P2|Participant Flow|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
332648|NCT00299221|P1|Participant Flow|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
332588|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332589|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332590|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332591|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332592|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332593|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332594|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332595|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332596|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332597|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332598|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332649|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
332650|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
332599|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332600|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332601|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332602|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332603|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332604|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332605|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332606|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332607|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332608|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332609|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332651|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
332652|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
332610|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332611|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332612|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332613|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332614|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332615|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332616|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332617|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332618|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332619|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332620|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332653|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
332654|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
332621|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332622|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332623|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332624|NCT00299130|E7|Reported Event|Rituximab 2 x 1.0 g + MTX – Extended Safety Follow-up Period|Participants received no treatment during the extended safety follow-up period.
332625|NCT00299130|E6|Reported Event|Rituximab 2 x 0.5 g + MTX – Extended Safety Follow-up Period|Participants received no treatment during the extended safety follow-up period.
332626|NCT00299130|E5|Reported Event|Switch Population: Rituximab|Includes all data from the point of switch for participants who switched from Placebo + Methotrexate to treatment with rituximab.
332627|NCT00299130|E4|Reported Event|Switch Population: Placebo + MTX|Includes all data up to the point of switch for participants in the Placebo + Methotrexate treatment group who switched to treatment with rituximab after Week 24.
332628|NCT00299130|E3|Reported Event|Rituximab 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332673|NCT00299546|P1|Participant Flow|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
332629|NCT00299130|E2|Reported Event|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332630|NCT00299130|E1|Reported Event|Placebo + MTX|"Includes all data for participants who remained on placebo, and data up to the point of switch if the participant switched to treatment with rituximab.
Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
332631|NCT00299156|B4|Baseline|Total|Total of all reporting groups
332632|NCT00299156|B3|Baseline|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332633|NCT00299156|B2|Baseline|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332634|NCT00299156|B1|Baseline|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332635|NCT00299156|P3|Participant Flow|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332636|NCT00299156|P2|Participant Flow|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332637|NCT00299156|P1|Participant Flow|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332638|NCT00299156|O3|Outcome|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332639|NCT00299156|O2|Outcome|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332640|NCT00299156|O1|Outcome|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332641|NCT00299156|E3|Reported Event|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332642|NCT00299156|E2|Reported Event|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332643|NCT00299156|E1|Reported Event|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
332644|NCT00299221|B3|Baseline|Total|Total of all reporting groups
332725|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332663|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
332664|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
332665|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
332666|NCT00299416|E1|Reported Event|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
332667|NCT00299546|B4|Baseline|Total|Total of all reporting groups
332668|NCT00299546|B3|Baseline|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
332669|NCT00299546|B2|Baseline|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
332670|NCT00299546|B1|Baseline|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
332671|NCT00299546|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
332672|NCT00299546|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
332674|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
332704|NCT00299702|P2|Participant Flow|Abilify|10-30 mg once daily oral for 104 weeks
332676|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
332677|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
332678|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
332679|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
332680|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
332681|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
332682|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
332683|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
332684|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
332685|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
332686|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
339168|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
332687|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
332688|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
332689|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
332690|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
332691|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
332692|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
332693|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
332694|NCT00299546|E3|Reported Event|Group 3: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study.
332695|NCT00299546|E2|Reported Event|Group 2: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study.
332696|NCT00299546|E1|Reported Event|Group 1: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study.
332697|NCT00299689|B1|Baseline|Intervention|"Single-arm: Ontak
Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
332698|NCT00299689|P1|Participant Flow|Intervention|"Single-arm: Ontak
Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
332699|NCT00299689|O1|Outcome|Intervention|"Single-arm: Ontak
Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
332700|NCT00299689|E1|Reported Event|Intervention|"Single-arm: Ontak
Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
332701|NCT00299702|B3|Baseline|Total|Total of all reporting groups
332708|NCT00299702|O2|Outcome|Abilify|10-30 mg once daily oral for 104 weeks
332709|NCT00299702|O1|Outcome|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
332710|NCT00299702|E2|Reported Event|Abilify|10-30 mg once daily oral for 104 weeks
332711|NCT00299702|E1|Reported Event|RISPERDAL CONSTA|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
332712|NCT00299741|B1|Baseline|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
332713|NCT00299741|P1|Participant Flow|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib administered orally at a dosage of 37.5 mg once daily
332714|NCT00299741|O1|Outcome|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
332715|NCT00299741|O1|Outcome|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
332716|NCT00299741|E1|Reported Event|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
332717|NCT00299975|B4|Baseline|Total|Total of all reporting groups
332718|NCT00299975|B3|Baseline|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332719|NCT00299975|B2|Baseline|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332720|NCT00299975|B1|Baseline|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332721|NCT00299975|P3|Participant Flow|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332722|NCT00299975|P2|Participant Flow|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332723|NCT00299975|P1|Participant Flow|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332724|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332845|NCT00300430|B1|Baseline|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332726|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332727|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332728|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332729|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332730|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332731|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332732|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332733|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332734|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332735|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332736|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332737|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332738|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332739|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332740|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332741|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332742|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332743|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332744|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332745|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332746|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332747|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332748|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332749|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332750|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332751|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332752|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332753|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332754|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332755|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332756|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332757|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332758|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332759|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332760|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332761|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332762|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332763|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332764|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332765|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332766|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332767|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332768|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332769|NCT00299975|E3|Reported Event|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332770|NCT00299975|E2|Reported Event|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332771|NCT00299975|E1|Reported Event|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
332772|NCT00300235|B6|Baseline|Total|Total of all reporting groups
332773|NCT00300235|B5|Baseline|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
332774|NCT00300235|B4|Baseline|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
332775|NCT00300235|B3|Baseline|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
332776|NCT00300235|B2|Baseline|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
332777|NCT00300235|B1|Baseline|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
332778|NCT00300235|P5|Participant Flow|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
332779|NCT00300235|P4|Participant Flow|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
332780|NCT00300235|P3|Participant Flow|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
332781|NCT00300235|P2|Participant Flow|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
332782|NCT00300235|P1|Participant Flow|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
332783|NCT00300235|O5|Outcome|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
332784|NCT00300235|O4|Outcome|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
332785|NCT00300235|O3|Outcome|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
332786|NCT00300235|O2|Outcome|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
332787|NCT00300235|O1|Outcome|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
332788|NCT00300235|E5|Reported Event|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
332789|NCT00300235|E4|Reported Event|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
332790|NCT00300235|E3|Reported Event|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
332791|NCT00300235|E2|Reported Event|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
332792|NCT00300235|E1|Reported Event|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
332793|NCT00300274|B4|Baseline|Total|Total of all reporting groups
332794|NCT00300274|B3|Baseline|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332795|NCT00300274|B2|Baseline|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332796|NCT00300274|B1|Baseline|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332797|NCT00300274|P3|Participant Flow|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332798|NCT00300274|P2|Participant Flow|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332912|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
332799|NCT00300274|P1|Participant Flow|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332800|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332801|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332802|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332803|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332804|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332805|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332806|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332807|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332808|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332809|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332810|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332884|NCT00300456|B2|Baseline|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
332811|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332812|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332813|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332814|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332815|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332816|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332817|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332818|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332846|NCT00300430|P3|Participant Flow|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332847|NCT00300430|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332819|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332820|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332821|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332822|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332823|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332824|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332825|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332826|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332827|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332828|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332829|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332830|NCT00300274|E3|Reported Event|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
332831|NCT00300274|E2|Reported Event|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
332832|NCT00300274|E1|Reported Event|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
332833|NCT00300365|B3|Baseline|Total|Total of all reporting groups
332834|NCT00300365|B2|Baseline|Active Pioglitazone + Open-Label Niacin + Asprin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
332835|NCT00300365|B1|Baseline|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
332836|NCT00300365|P2|Participant Flow|Active Pioglitazone + Open-Label Niacin + Aspirin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and aspirin 325 mg. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
332837|NCT00300365|P1|Participant Flow|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and aspirin 325 mg
332838|NCT00300365|O2|Outcome|Active Pioglitazone + Open-Label Niacin + Asprin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
332839|NCT00300365|O1|Outcome|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
332840|NCT00300365|E2|Reported Event|Active Pioglitazone + Open-Label Niacin + Asprin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
332841|NCT00300365|E1|Reported Event|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
332842|NCT00300430|B4|Baseline|Total|Total of all reporting groups
332843|NCT00300430|B3|Baseline|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332844|NCT00300430|B2|Baseline|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332850|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332851|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332852|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332853|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332854|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332855|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332856|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332857|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332858|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332859|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332860|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332861|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332862|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332863|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332864|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332865|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332866|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332867|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332868|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332869|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332870|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332871|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332872|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332873|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332874|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332875|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332876|NCT00300430|E3|Reported Event|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
332877|NCT00300430|E2|Reported Event|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
332878|NCT00300430|E1|Reported Event|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
332879|NCT00300456|B7|Baseline|Total|Total of all reporting groups
332880|NCT00300456|B6|Baseline|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
332881|NCT00300456|B5|Baseline|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
332882|NCT00300456|B4|Baseline|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
332883|NCT00300456|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
332885|NCT00300456|B1|Baseline|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
332886|NCT00300456|P6|Participant Flow|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
332887|NCT00300456|P5|Participant Flow|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
332888|NCT00300456|P4|Participant Flow|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
332889|NCT00300456|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
332890|NCT00300456|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
332891|NCT00300456|P1|Participant Flow|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
332892|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
332893|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
332894|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
332895|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332896|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
332897|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
332898|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
332899|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
332900|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
332901|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332902|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
332903|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
332904|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
332905|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
332906|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
332907|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332908|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
332909|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
332910|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
332911|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
332914|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
332915|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
332916|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
332917|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
332918|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
332919|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332920|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
332921|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
332922|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
332923|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
332924|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
332925|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332926|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
332927|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
332928|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
332929|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
332930|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
332931|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332932|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
332933|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
332934|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
332935|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
332936|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
332937|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332938|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
332939|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
332940|NCT00300456|E6|Reported Event|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
332941|NCT00300456|E5|Reported Event|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
332942|NCT00300456|E4|Reported Event|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
332943|NCT00300456|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
332944|NCT00300456|E2|Reported Event|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
332945|NCT00300456|E1|Reported Event|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
332946|NCT00300469|B7|Baseline|Total|Total of all reporting groups
332947|NCT00300469|B6|Baseline|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
332948|NCT00300469|B5|Baseline|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
332949|NCT00300469|B4|Baseline|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
332950|NCT00300469|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
333157|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
332951|NCT00300469|B2|Baseline|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
332952|NCT00300469|B1|Baseline|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
332953|NCT00300469|P6|Participant Flow|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
332954|NCT00300469|P5|Participant Flow|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
332955|NCT00300469|P4|Participant Flow|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
332956|NCT00300469|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
332957|NCT00300469|P2|Participant Flow|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
332958|NCT00300469|P1|Participant Flow|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
332959|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
332960|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
332961|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
332962|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332963|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
332964|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
332965|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
332966|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
332967|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
332968|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332969|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
332970|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
332971|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
332972|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
332973|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
332974|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332975|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
332976|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
332977|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
332981|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
332982|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
332983|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
332984|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
332985|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
332986|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332987|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
332988|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
332989|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
332990|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
332991|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
332992|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332993|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
332994|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
332995|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
332996|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
332997|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
332998|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
332999|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
333000|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
333001|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
333002|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
333003|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
333004|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
333005|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
333006|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
333007|NCT00300469|E6|Reported Event|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
333008|NCT00300469|E5|Reported Event|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
333009|NCT00300469|E4|Reported Event|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
333010|NCT00300469|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
333011|NCT00300469|E2|Reported Event|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
333012|NCT00300469|E1|Reported Event|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
333013|NCT00300482|B7|Baseline|Total|Total of all reporting groups
333014|NCT00300482|B6|Baseline|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
333015|NCT00300482|B5|Baseline|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
333016|NCT00300482|B4|Baseline|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
333017|NCT00300482|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
333018|NCT00300482|B2|Baseline|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
333019|NCT00300482|B1|Baseline|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
333020|NCT00300482|P6|Participant Flow|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
333021|NCT00300482|P5|Participant Flow|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
333022|NCT00300482|P4|Participant Flow|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
333023|NCT00300482|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
333024|NCT00300482|P2|Participant Flow|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
333025|NCT00300482|P1|Participant Flow|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
333026|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
333027|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
333028|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
333029|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
333030|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
333031|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
333032|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
333033|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
333034|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
333035|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
333036|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
333037|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
333038|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
333039|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
333040|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
333041|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
333042|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
333043|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
333044|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
333046|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
333047|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
333048|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
333049|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
333050|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
333051|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
333052|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
333053|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
333054|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
333055|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
333056|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
333057|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
333058|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
333059|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
333060|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
333061|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
333062|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
333063|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
333064|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
333065|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
333066|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
333067|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
333068|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
333069|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
333070|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
333071|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
333072|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
333073|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
333074|NCT00300482|E6|Reported Event|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
333075|NCT00300482|E5|Reported Event|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
333076|NCT00300482|E4|Reported Event|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
333077|NCT00300482|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
333078|NCT00300482|E2|Reported Event|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
333079|NCT00300482|E1|Reported Event|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
333080|NCT00300495|B3|Baseline|Total|Total of all reporting groups
333081|NCT00300495|B2|Baseline|2 - Control|"Control arm, standard care with no perioperative amiodarone
Control arm, standard care: Control"
333082|NCT00300495|B1|Baseline|1 - Amiodarone|"Perioperative amiodarone
Amiodarone: Perioperative orally administered"
333083|NCT00300495|P2|Participant Flow|2 - Control|"Control arm, standard care with no perioperative amiodarone
Control arm, standard care: Control"
333084|NCT00300495|P1|Participant Flow|1 - Amiodarone|"Perioperative amiodarone
Amiodarone: Perioperative orally administered
Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
333085|NCT00300495|O2|Outcome|2 - Control|"Control arm, standard care with no perioperative amiodarone
Control arm, standard care: Control"
333086|NCT00300495|O1|Outcome|1 - Amiodarone|"Perioperative amiodarone
Amiodarone: Perioperative orally administered
Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
333087|NCT00300495|O2|Outcome|2 - Control|"Control arm, standard care with no perioperative amiodarone
Control arm, standard care: Control"
333088|NCT00300495|O1|Outcome|1 - Amiodarone|"Perioperative amiodarone
Amiodarone: Perioperative orally administered
Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
333089|NCT00300495|E2|Reported Event|2 - Control|"Control arm, standard care with no perioperative amiodarone
Control arm, standard care: Control"
333090|NCT00300495|E1|Reported Event|1 - Amiodarone|"Perioperative amiodarone
Amiodarone: Perioperative orally administered
Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
333091|NCT00307333|B3|Baseline|Total|Total of all reporting groups
333092|NCT00307333|B2|Baseline|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
333093|NCT00307333|B1|Baseline|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
333094|NCT00307333|P2|Participant Flow|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
333095|NCT00307333|P1|Participant Flow|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
333096|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
333097|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
333098|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
333344|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333099|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
333100|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
333101|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
333102|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
333103|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
333104|NCT00307333|E2|Reported Event|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
333105|NCT00307333|E1|Reported Event|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
333106|NCT00307437|B4|Baseline|Total|Total of all reporting groups
333107|NCT00307437|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
333108|NCT00307437|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal to 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
333109|NCT00307437|B1|Baseline|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
333110|NCT00307437|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244.
333111|NCT00307437|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
333112|NCT00307437|P5|Participant Flow|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244.
333113|NCT00307437|P4|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 12 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
333114|NCT00307437|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
333115|NCT00307437|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
333116|NCT00307437|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
333117|NCT00307437|O6|Outcome|Group 6: Combined (12 Week Dosing)|Combined Groups 2 and 4 (dosing every 12 weeks)
333118|NCT00307437|O5|Outcome|Group 5: Combined (8 Week Dosing)|Combined Groups 1 and 3 (dosing every 8 weeks)
333247|NCT00308139|O3|Outcome|All Treatment|
333119|NCT00307437|O4|Outcome|Group 4: Ustekinumab 90 mg Every 12 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40.
333120|NCT00307437|O3|Outcome|Group 3: Ustekinumab 90 mg Every 8 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 4, 16., 28, 36 and 44.
333121|NCT00307437|O2|Outcome|Group 2: Ustekinumab 45mg Every 12 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 4, 16, 28 and 40.
333122|NCT00307437|O1|Outcome|Group 1: Ustekinumab 45mg Every 8 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 4, 16, 28, 36 and 44.
333123|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
333124|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
333125|NCT00307437|O1|Outcome|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
333126|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Partcipants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal to 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
333127|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Partcipants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
333128|NCT00307437|O1|Outcome|Group I: Placebo|Placebo partcipants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
333129|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Partcipants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
333412|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333130|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Partcipants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
333131|NCT00307437|O1|Outcome|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
333132|NCT00307437|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244.
333133|NCT00307437|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
333134|NCT00307437|E5|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244.
333135|NCT00307437|E4|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 12 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
333136|NCT00307437|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
333137|NCT00307437|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
333138|NCT00307437|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
333139|NCT00307489|B3|Baseline|Total|Total of all reporting groups
333140|NCT00307489|B2|Baseline|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333141|NCT00307489|B1|Baseline|Tenofovir DF|tenofovir DF 300 mg QD
333142|NCT00307489|P2|Participant Flow|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333143|NCT00307489|P1|Participant Flow|Tenofovir DF|tenofovir DF 300 mg QD
333144|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333145|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333146|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333147|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333148|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333149|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333150|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333151|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333152|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333153|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333154|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333155|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333156|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333158|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333159|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333160|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333161|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333162|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333163|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333164|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333165|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333166|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333167|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333168|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333169|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333170|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333171|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333172|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333173|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333174|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333175|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333176|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333177|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333178|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333179|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333180|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333181|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
333182|NCT00307489|E2|Reported Event|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
333183|NCT00307489|E1|Reported Event|Tenofovir DF|tenofovir DF 300 mg QD
333184|NCT00308113|B5|Baseline|Total|Total of all reporting groups
333185|NCT00308113|B4|Baseline|Enhanced Standard of Care|Enhanced standard of care.
333186|NCT00308113|B3|Baseline|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.
Prednisone : Prednisone 0/75 mg/kg/day."
333187|NCT00308113|B2|Baseline|Prednisone Alone|"Prednisone taken once a day each morning by mouth
Prednisone : Prednisone 0/75 mg/kg/day."
333188|NCT00308113|B1|Baseline|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
333189|NCT00308113|P4|Participant Flow|Enhanced Standard of Care|Enhanced standard of care.
333190|NCT00308113|P3|Participant Flow|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.
Prednisone : Prednisone 0/75 mg/kg/day."
333191|NCT00308113|P2|Participant Flow|Prednisone Alone|"Prednisone taken once a day each morning by mouth
Prednisone : Prednisone 0/75 mg/kg/day."
333192|NCT00308113|P1|Participant Flow|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
333193|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
333194|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.
Prednisone : Prednisone 0/75 mg/kg/day."
333195|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth
Prednisone : Prednisone 0/75 mg/kg/day."
333196|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
333197|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
333198|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.
Prednisone : Prednisone 0/75 mg/kg/day."
333199|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth
Prednisone : Prednisone 0/75 mg/kg/day."
333200|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
333201|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
333202|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.
Prednisone : Prednisone 0/75 mg/kg/day."
333203|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth
Prednisone : Prednisone 0/75 mg/kg/day."
333204|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
333205|NCT00308113|E4|Reported Event|Enhanced Standard of Care|Enhanced standard of care.
333206|NCT00308113|E3|Reported Event|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.
Prednisone : Prednisone 0/75 mg/kg/day."
333207|NCT00308113|E2|Reported Event|Prednisone Alone|"Prednisone taken once a day each morning by mouth
Prednisone : Prednisone 0/75 mg/kg/day."
333208|NCT00308113|E1|Reported Event|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.
Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
333209|NCT00308139|B3|Baseline|Total|Total of all reporting groups
333379|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333210|NCT00308139|B2|Baseline|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333211|NCT00308139|B1|Baseline|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333212|NCT00308139|P2|Participant Flow|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333213|NCT00308139|P1|Participant Flow|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333214|NCT00308139|O5|Outcome|Exenatide Once Weekly With Non-SU|Subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
333215|NCT00308139|O4|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly With Non-SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364.
333216|NCT00308139|O3|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly With Non-SU|Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364
333217|NCT00308139|O2|Outcome|Exenatide Twice Daily With Non-SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) not using concomitant SU at screening. Week 0 to week 30.
333218|NCT00308139|O1|Outcome|Exenatide Once Weekly With Non-SU|Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 0 to week 30.
333219|NCT00308139|O5|Outcome|Exenatide Once Weekly With SU|Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
333220|NCT00308139|O4|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
333221|NCT00308139|O3|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly With SU|Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364
333343|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333222|NCT00308139|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) using concomitant SU at screening. Week 0 to week 30.
333223|NCT00308139|O1|Outcome|Exenatide Once Weekly With SU|Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 0 to week 30.
333224|NCT00308139|O3|Outcome|All Treatment|
333225|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333226|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333227|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
333228|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333229|NCT00308139|O3|Outcome|All Treatment|
333230|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333231|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333232|NCT00308139|O3|Outcome|All Treatment|
333233|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333234|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333235|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
333236|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333237|NCT00308139|O3|Outcome|All Treatment|
333238|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333239|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333240|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
333241|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333242|NCT00308139|O3|Outcome|All Treatment|
333243|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once WeeklyEdit|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333244|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333245|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
333246|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333248|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333249|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333250|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
333251|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333252|NCT00308139|O3|Outcome|All Treatment|
333253|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333254|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333255|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 week).
333256|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333257|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
333258|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333259|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333260|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
333261|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333262|NCT00308139|O3|Outcome|All Treatmeat|
333263|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333264|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333265|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
333266|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333268|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333269|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333270|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
333271|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333272|NCT00308139|O3|Outcome|All Treatment|
333273|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333274|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333275|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333276|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
333277|NCT00308139|E5|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
333278|NCT00308139|E4|Reported Event|Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364)|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
333279|NCT00308139|E3|Reported Event|Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364)|Subcutaneous injection of 2 mg exenatide, once a week.
333280|NCT00308139|E2|Reported Event|Exenatide Twice Daily (WK 0-30)|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
333281|NCT00308139|E1|Reported Event|Exenatide Once Weekly (WK 0-30)|Subcutaneous injection of 2 mg exenatide, once a week.
333282|NCT00308230|B4|Baseline|Total|Total of all reporting groups
333283|NCT00308230|B3|Baseline|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
333284|NCT00308230|B2|Baseline|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
333285|NCT00308230|B1|Baseline|Control|Structurally normal heart without heart disease
333286|NCT00308230|P3|Participant Flow|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
333287|NCT00308230|P2|Participant Flow|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
333288|NCT00308230|P1|Participant Flow|Control Group|Structurally normal heart without heart disease.
333289|NCT00308230|O3|Outcome|Heart Failure|Left ventricular failure
333290|NCT00308230|O2|Outcome|Congenital Heart Disease|TOF, DTGA, CCTGA-tetralogy of Fallot, the transposition of the great arteries, congenitally corrected transposition
333291|NCT00308230|O1|Outcome|Control Group|Structurally normal hearts
333292|NCT00308230|E3|Reported Event|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
333293|NCT00308230|E2|Reported Event|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
333294|NCT00308230|E1|Reported Event|Control Group|Structurally normal heart without heart disease
333295|NCT00308308|B3|Baseline|Total|Total of all reporting groups
333296|NCT00308308|B2|Baseline|Insulin Aspart + Insulin Glargine|Comparator
333297|NCT00308308|B1|Baseline|TI + Insulin Glargine|TI + Insulin glargine
333298|NCT00308308|P2|Participant Flow|Insulin Aspart + Insulin Glargine|Comparator
333299|NCT00308308|P1|Participant Flow|TI + Insulin Glargine|TI + Insulin glargine
333300|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
333301|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
333302|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
333303|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
333304|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
333305|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
333306|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
333307|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
333308|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
333309|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
333310|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
333311|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
333312|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
333313|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
333314|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
333315|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
333316|NCT00308308|E2|Reported Event|Insulin Aspart + Insulin Glargine|Comparator
333317|NCT00308308|E1|Reported Event|TI + Insulin Glargine|TI + Insulin glargine
333318|NCT00308516|B3|Baseline|Total|Total of all reporting groups
333319|NCT00308516|B2|Baseline|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.
Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
333537|NCT00308737|O2|Outcome|Usual Care|Usual care
333320|NCT00308516|B1|Baseline|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.
At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
333321|NCT00308516|P2|Participant Flow|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.
Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
333322|NCT00308516|P1|Participant Flow|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.
At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
333323|NCT00308516|O2|Outcome|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.
Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
333324|NCT00308516|O1|Outcome|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.
At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
333380|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333381|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333382|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333383|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333325|NCT00308516|E2|Reported Event|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.
Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
333326|NCT00308516|E1|Reported Event|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.
At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
333327|NCT00308555|B3|Baseline|Total|Total of all reporting groups
333328|NCT00308555|B2|Baseline|Oxycontin|Patients using oxycodone hydrochloride (OxyContin)every 12 hours for chronic pain
333329|NCT00308555|B1|Baseline|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain
333330|NCT00308555|P2|Participant Flow|Oxycontin|Patients using oxycodone hydrochloride (OxyContin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
333331|NCT00308555|P1|Participant Flow|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
333332|NCT00308555|O2|Outcome|Oxycodone|Participants on oxycodone treatment
333333|NCT00308555|O1|Outcome|MS Contin|Participants on morphine treatment
333334|NCT00308555|E2|Reported Event|Oxycontin|Patients using oxycodone hydrochloride (OxyContin)every 12 hours for cancer pain
333335|NCT00308555|E1|Reported Event|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for cancer pain
333336|NCT00308581|B1|Baseline|Overall|Overall Induction
333337|NCT00308581|P3|Participant Flow|Overall|Overall Induction
333338|NCT00308581|P2|Participant Flow|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333339|NCT00308581|P1|Participant Flow|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333340|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333341|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333342|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333538|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
333345|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333346|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333347|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333348|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333349|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333350|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333351|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333352|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333353|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333354|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333355|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333356|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333357|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333358|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333359|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333360|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333361|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333362|NCT00308581|O1|Outcome|Overall|Overall Induction
333363|NCT00308581|O1|Outcome|Overall|Overall Induction
333364|NCT00308581|O1|Outcome|Overall|Overall Induction
333365|NCT00308581|O1|Outcome|Overall|Overall Induction
333366|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333367|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333368|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333369|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333370|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333371|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333372|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333373|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333374|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333375|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333376|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333377|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333378|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333384|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333385|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333386|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333387|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333388|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333389|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333390|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333391|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333392|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333393|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333394|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333395|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333396|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333397|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333398|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333399|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333400|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333401|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333402|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333403|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333404|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333405|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333406|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333407|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333408|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333409|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333410|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333411|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333413|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333414|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333415|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333416|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333417|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333418|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333419|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333420|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333421|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333422|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333423|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333424|NCT00308581|O1|Outcome|Overall|Overall Induction
333425|NCT00308581|O1|Outcome|Overall|Overall Induction
333426|NCT00308581|O1|Outcome|Overall|Overall Induction
333427|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333428|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333429|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333430|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333431|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333432|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333433|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333434|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333435|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333436|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333437|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333438|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333439|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333440|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333441|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333442|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333443|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333444|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333445|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333446|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333447|NCT00308581|O1|Outcome|Overall|Overall Induction
333448|NCT00308581|O1|Outcome|Overall|Overall Induction
333449|NCT00308581|O1|Outcome|Overall|Overall Induction
333450|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333451|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333452|NCT00308581|O1|Outcome|Overall|Overall Induction
333453|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333454|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333455|NCT00308581|O1|Outcome|Overall|Overall Induction
333456|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
333457|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
333458|NCT00308581|O1|Outcome|Overall|Overall Induction
333459|NCT00308581|E3|Reported Event|Induction Phase|Overall population in the Induction phase + safety follow-up period following induction phase.
333460|NCT00308581|E2|Reported Event|Q2W Regimen|Subjects who were randomized to and received Q2W regimen (every 2 weeks: 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.
333461|NCT00308581|E1|Reported Event|Q4W Regimen|Subjects who were randomized to and received Q4W regimen (every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.
333462|NCT00308620|B4|Baseline|Total|Total of all reporting groups
333463|NCT00308620|B3|Baseline|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
333464|NCT00308620|B2|Baseline|Placebo|Placebo once daily for 8 weeks
333465|NCT00308620|B1|Baseline|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
333466|NCT00308620|P3|Participant Flow|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
333467|NCT00308620|P2|Participant Flow|Placebo|Placebo once daily for 8 weeks
333468|NCT00308620|P1|Participant Flow|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
333469|NCT00308620|O2|Outcome|Placebo|Placebo orally once daily for 8 weeks
333470|NCT00308620|O1|Outcome|Chloroquine 250mg or 500mg|Chloroquine 500mg orally once daily x 8 weeks
333471|NCT00308620|O2|Outcome|Placebo|Placebo orally once daily for 8 weeks
333472|NCT00308620|O1|Outcome|Chloroquine 250mg or 500mg|Chloroquine 250mg or 500mg orally once daily x 8 weeks. n=6 for 250mg; n=3 for 500mg
333473|NCT00308620|E3|Reported Event|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
333474|NCT00308620|E2|Reported Event|Placebo|Placebo once daily for 8 weeks
333475|NCT00308620|E1|Reported Event|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
333476|NCT00308711|B4|Baseline|Total|Total of all reporting groups
333477|NCT00308711|B3|Baseline|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333539|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
333478|NCT00308711|B2|Baseline|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333479|NCT00308711|B1|Baseline|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333480|NCT00308711|P3|Participant Flow|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333481|NCT00308711|P2|Participant Flow|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333482|NCT00308711|P1|Participant Flow|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333483|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333484|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333485|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333486|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333487|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333488|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333489|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333490|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333491|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333492|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333493|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333494|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333495|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333496|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333497|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333498|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333499|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333500|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333501|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333502|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333503|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333504|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333505|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333506|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333507|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333508|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333509|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333510|NCT00308711|E3|Reported Event|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
333511|NCT00308711|E2|Reported Event|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
333512|NCT00308711|E1|Reported Event|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
333513|NCT00308737|B4|Baseline|Total|Total of all reporting groups
333514|NCT00308737|B3|Baseline|Non-diabetes|Subjects without abnormalities in glucose control
333515|NCT00308737|B2|Baseline|Usual Care|Usual care
333516|NCT00308737|B1|Baseline|Technosphere® Insulin|Technosphere Insulin
333517|NCT00308737|P3|Participant Flow|Non-diabetes|Subjects without abnormalities in glucose control
333518|NCT00308737|P2|Participant Flow|Usual Care|Usual care may consist of oral anti-diabetic medications, basal insulin, subcutaneous prandial insulin, or any combination of the previous.
333519|NCT00308737|P1|Participant Flow|Technosphere® Insulin|Technosphere Insulin with or without basal insulin, or oral anti-diabetic medications, or any combination of the previous.
333520|NCT00308737|O2|Outcome|Usual Care|Usual care
333521|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
333522|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
333523|NCT00308737|O2|Outcome|Usual Care|Usual care
333524|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
333525|NCT00308737|O2|Outcome|Usual Care|Usual care
333526|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
333527|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
333528|NCT00308737|O2|Outcome|Usual Care|Usual care
333529|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
333530|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
333531|NCT00308737|O2|Outcome|Usual Care|Usual care
333532|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
333533|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
333534|NCT00308737|O2|Outcome|Usual Care|Usual care
333535|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
333536|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
333542|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
333543|NCT00308737|O2|Outcome|Usual Care|Usual care
333544|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
333545|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
333546|NCT00308737|O2|Outcome|Usual Care|Usual care
333547|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
333548|NCT00308737|O2|Outcome|Usual Care|Usual care
333549|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
333550|NCT00308737|O2|Outcome|Usual Care|Usual care
333551|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
333552|NCT00308737|E3|Reported Event|Non-diabetes|Subjects without abnormalities in glucose control
333553|NCT00308737|E2|Reported Event|Usual Care|Usual care (taking insulin)
333554|NCT00308737|E1|Reported Event|Technosphere® Insulin|Technosphere Insulin
333555|NCT00308997|B3|Baseline|Total|Total of all reporting groups
333556|NCT00308997|B2|Baseline|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333557|NCT00308997|B1|Baseline|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333558|NCT00308997|P2|Participant Flow|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333559|NCT00308997|P1|Participant Flow|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333560|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333561|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333585|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
333562|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333563|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333564|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333565|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333566|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333567|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333568|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333735|NCT00309777|O4|Outcome|Simvastatin 40 mg|Simvastatn 40 mg once daily
333569|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333570|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333571|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333572|NCT00308997|E2|Reported Event|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333573|NCT00308997|E1|Reported Event|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
333574|NCT00309244|B3|Baseline|Total|Total of all reporting groups
333575|NCT00309244|B2|Baseline|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
333576|NCT00309244|B1|Baseline|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
333577|NCT00309244|P2|Participant Flow|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart subcutaneous injection (rDNA origin), administered twice daily (before breakfast and before main evening meal). Doses are individualized for each patient.
333578|NCT00309244|P1|Participant Flow|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder (administered at each meal) + subcutaneous insulin glargine (administered once daily at bedtime). Doses are individualized for each patient.
333579|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
333580|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
333581|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
333582|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
333583|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
333584|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
334058|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
333586|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
333587|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
333588|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
333589|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
333590|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
333591|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
333592|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
333593|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
333594|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
333595|NCT00309244|E2|Reported Event|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
333596|NCT00309244|E1|Reported Event|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
333597|NCT00309387|B3|Baseline|Total|Total of all reporting groups
333598|NCT00309387|B2|Baseline|Placebo|
333599|NCT00309387|B1|Baseline|Treatment|
333600|NCT00309387|P2|Participant Flow|Placebo|
333601|NCT00309387|P1|Participant Flow|Treatment|
333602|NCT00309387|O2|Outcome|Placebo|Placebo
333603|NCT00309387|O1|Outcome|Treatment|Centrum
333604|NCT00309387|O2|Outcome|Placebo|Placebo
333605|NCT00309387|O1|Outcome|Treatment|Centrum
333606|NCT00309387|O2|Outcome|Placebo|Placebo
333607|NCT00309387|O1|Outcome|Treatment|Centrum
333608|NCT00309387|O2|Outcome|Placebo|placebo
333609|NCT00309387|O1|Outcome|Treatment|Centrum
333610|NCT00309387|O2|Outcome|Placebo|Placebo
333611|NCT00309387|O1|Outcome|Treatment|Centrum
333612|NCT00309387|O2|Outcome|Placebo|Placebo
333613|NCT00309387|O1|Outcome|Treatment|Centrum
333614|NCT00309387|E2|Reported Event|Placebo|
333615|NCT00309387|E1|Reported Event|Treatment|
333616|NCT00309452|B3|Baseline|Total|Total of all reporting groups
333665|NCT00309465|E5|Reported Event|Call Physician (Insulin Glargine Plus Bolus Group)|Subjects called physician for the insulin glargine dose to administer on the evening before surgery.
333666|NCT00309465|E4|Reported Event|Take 80% (Insuling Glargine Plus Bolus Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
333617|NCT00309452|B2|Baseline|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333618|NCT00309452|B1|Baseline|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333619|NCT00309452|P2|Participant Flow|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333620|NCT00309452|P1|Participant Flow|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333621|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333622|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333649|NCT00309465|B3|Baseline|Dose Table (Insulin Glargine Only Group)|Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual fasting blood glucose range was > or = 150 mg/dl.
333650|NCT00309465|B2|Baseline|Call Physician (Insulin Glargine Only Group)|Subjects were instructed to call their physician for the insulin glargine dose to administer the evening before surgery.
333623|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333624|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333625|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333626|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333627|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333628|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333730|NCT00309777|P1|Participant Flow|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
333731|NCT00309777|O4|Outcome|Simvastatin 40 mg|Simvastatn 40 mg once daily
339169|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
333629|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333630|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333631|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333632|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333633|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333634|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333635|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333636|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333637|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333638|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333639|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333640|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333732|NCT00309777|O3|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
333733|NCT00309777|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg once daily
333734|NCT00309777|O1|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
333641|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333642|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333643|NCT00309452|E2|Reported Event|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
333644|NCT00309452|E1|Reported Event|Treatment as Usual|"Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
333645|NCT00309465|B7|Baseline|Total|Total of all reporting groups
333646|NCT00309465|B6|Baseline|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl.
333647|NCT00309465|B5|Baseline|Call Physician (Insulin Glargine Plus Bolus Group|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
333648|NCT00309465|B4|Baseline|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
333651|NCT00309465|B1|Baseline|Take 80% (Insulin Glargine Only Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
334059|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
333652|NCT00309465|P6|Participant Flow|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose value was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl.
333653|NCT00309465|P5|Participant Flow|Call Physician (Insulin Glargine Plus Bolus Group|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
333654|NCT00309465|P4|Participant Flow|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
333655|NCT00309465|P3|Participant Flow|Dose Table (Insulin Glargine Only Group)|Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose value was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was > or = 150 mg/dl.
333656|NCT00309465|P2|Participant Flow|Call Physician (Insulin Glargine Only Group)|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
333657|NCT00309465|P1|Participant Flow|Take 80% (Insulin Glargine Only Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
333658|NCT00309465|O6|Outcome|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects administered: (a) 80% of their usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of their usual insulin glargine dose if midpoint of self-reported usual fasting blood glucose ragne was > or = 150 mg/dl
333659|NCT00309465|O5|Outcome|Call Physician (Insulin Glargine Plus Bolus Group|Subjects called their own physicians for the insulin glargine dose to administer on the evening before surgery
333660|NCT00309465|O4|Outcome|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects self-administered 80% of the usual insulin glargine dose on the evening before surgery
333661|NCT00309465|O3|Outcome|Dose Table (Insulin Glargine Only Group)|Subjects administered: (a) 50% of their usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was > or = 150 mg/dl
333662|NCT00309465|O2|Outcome|Call Physician (Insulin Glargine Only Group)|Subjects called their own physicians for insulin glargine dose on the evening before surgery
333663|NCT00309465|O1|Outcome|Take 80% (Insulin Glargine Only Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
333664|NCT00309465|E6|Reported Event|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects administered: (a) 80% of usual insulin glargine if midpoint of usual self-reported fasting blood glucose was <150 mg/dl or (b) 100% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose was < or =150 mg/dl.
333667|NCT00309465|E3|Reported Event|Dose Table (Insulin Glargine Only Group)|Subjects administered: (a) 50% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose > or =150 mg/dl
333668|NCT00309465|E2|Reported Event|Call Physician (Insulin Glargine Only Group)|Subjects called physician for the insulin glargine dose on the evening before surgery.
333669|NCT00309465|E1|Reported Event|Take 80% (Insulin Glargine Only Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
333670|NCT00309608|B6|Baseline|Total|Total of all reporting groups
333671|NCT00309608|B5|Baseline|Glimepiride|Patients randomized to receive treatment with Glimepiride
333672|NCT00309608|B4|Baseline|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
333673|NCT00309608|B3|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
333674|NCT00309608|B2|Baseline|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
333675|NCT00309608|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
333676|NCT00309608|P5|Participant Flow|Glimepiride|Patients randomized to receive treatment with Glimepiride
333677|NCT00309608|P4|Participant Flow|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
333678|NCT00309608|P3|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
333679|NCT00309608|P2|Participant Flow|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
333680|NCT00309608|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
333681|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
333682|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
333683|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
333684|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
333685|NCT00309608|O5|Outcome|Glimepiride|Patients randomized to receive treatment with Glimepiride
333686|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
333687|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
333688|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
333689|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
333690|NCT00309608|O5|Outcome|Glimepiride|Patients randomized to receive treatment with Glimepiride
333691|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
333692|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
333693|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
333694|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
333695|NCT00309608|E5|Reported Event|Glimepiride|Patients randomized to receive treatment with Glimepiride
333696|NCT00309608|E4|Reported Event|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
333697|NCT00309608|E3|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
333698|NCT00309608|E2|Reported Event|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
333699|NCT00309608|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
333700|NCT00309738|B3|Baseline|Total|Total of all reporting groups
333701|NCT00309738|B2|Baseline|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
333702|NCT00309738|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
333703|NCT00309738|P2|Participant Flow|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
333704|NCT00309738|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
333705|NCT00309738|O2|Outcome|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
333706|NCT00309738|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
333707|NCT00309738|O2|Outcome|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
333708|NCT00309738|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
333709|NCT00309738|E2|Reported Event|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
333710|NCT00309738|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
333711|NCT00309751|B3|Baseline|Total|Total of all reporting groups
333712|NCT00309751|B2|Baseline|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
333713|NCT00309751|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
333714|NCT00309751|P2|Participant Flow|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
333715|NCT00309751|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
333716|NCT00309751|O2|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
333717|NCT00309751|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
333718|NCT00309751|O2|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
333719|NCT00309751|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
333720|NCT00309751|E2|Reported Event|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
333721|NCT00309751|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
333722|NCT00309777|B5|Baseline|Total|Total of all reporting groups
333723|NCT00309777|B4|Baseline|Simvastatin 40 mg|Simvastatn 40 mg once daily
333724|NCT00309777|B3|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
333725|NCT00309777|B2|Baseline|Simvastatin 20 mg|Simvastatin 20 mg once daily
333726|NCT00309777|B1|Baseline|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
333727|NCT00309777|P4|Participant Flow|Simvastatin 40 mg|Simvastatn 40 mg once daily
333728|NCT00309777|P3|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
333729|NCT00309777|P2|Participant Flow|Simvastatin 20 mg|Simvastatin 20 mg once daily
333736|NCT00309777|O3|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
333737|NCT00309777|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg once daily
333738|NCT00309777|O1|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
333739|NCT00309777|E4|Reported Event|Simvastatin 40 mg|Simvastatn 40 mg once daily
333740|NCT00309777|E3|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
333741|NCT00309777|E2|Reported Event|Simvastatin 20 mg|Simvastatin 20 mg once daily
333742|NCT00309777|E1|Reported Event|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
333743|NCT00309907|B1|Baseline|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.
etanercept: Given IV and subcutaneously
methylprednisolone: Given IV and orally"
333744|NCT00309907|P1|Participant Flow|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.
etanercept: Given IV and subcutaneously
methylprednisolone: Given IV and orally"
333745|NCT00309907|O1|Outcome|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.
etanercept: Given IV and subcutaneously
methylprednisolone: Given IV and orally"
333746|NCT00309907|E1|Reported Event|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.
etanercept: Given IV and subcutaneously
methylprednisolone: Given IV and orally"
333747|NCT00309946|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
333852|NCT00310375|O1|Outcome|Overall Study|
333748|NCT00309946|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
333749|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
333750|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
333751|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
333752|NCT00309946|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
333753|NCT00309985|B3|Baseline|Total|Total of all reporting groups
333754|NCT00309985|B2|Baseline|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
333755|NCT00309985|B1|Baseline|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
333756|NCT00309985|P2|Participant Flow|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
333757|NCT00309985|P1|Participant Flow|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
333758|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
333883|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
333885|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
333759|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
333760|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
333761|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
333762|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
333763|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
333764|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
333765|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
333766|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
333767|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
333768|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
333769|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
334060|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
333770|NCT00309985|E2|Reported Event|Arm B|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
333771|NCT00309985|E1|Reported Event|Arm A|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
333772|NCT00310076|B1|Baseline|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
333773|NCT00310076|P1|Participant Flow|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
333774|NCT00310076|O1|Outcome|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
333775|NCT00310076|E1|Reported Event|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
333776|NCT00310310|B3|Baseline|Total|Total of all reporting groups
333777|NCT00310310|B2|Baseline|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333778|NCT00310310|B1|Baseline|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333779|NCT00310310|P2|Participant Flow|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333780|NCT00310310|P1|Participant Flow|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333781|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333782|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333783|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333784|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333785|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333786|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333884|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
333787|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333788|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333789|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333790|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333791|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333792|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333793|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333794|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333795|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333796|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333797|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333798|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333799|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333800|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333801|NCT00310310|E2|Reported Event|Self-Management|"sleep apnea self-management program - 4 sessions, group-based
Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
333802|NCT00310310|E1|Reported Event|Usual Care|"Usual sleep apnea and cpap care
Usual care: Usual sleep apnea and cpap care"
333803|NCT00310362|B4|Baseline|Total|Total of all reporting groups
333804|NCT00310362|B3|Baseline|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
333805|NCT00310362|B2|Baseline|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures..
333806|NCT00310362|B1|Baseline|Usual Care|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
333807|NCT00310362|P3|Participant Flow|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
333808|NCT00310362|P2|Participant Flow|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
333809|NCT00310362|P1|Participant Flow|Usual Care|Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.
333810|NCT00310362|O3|Outcome|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
333811|NCT00310362|O2|Outcome|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
333812|NCT00310362|O1|Outcome|Usual Care|Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.
333813|NCT00310362|E3|Reported Event|IVR7|Arm 2 (IVR3) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
333814|NCT00310362|E2|Reported Event|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
333815|NCT00310362|E1|Reported Event|Usual Care|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
333816|NCT00310375|B3|Baseline|Total|Total of all reporting groups
333817|NCT00310375|B2|Baseline|Retigabine in Parent Study|
333818|NCT00310375|B1|Baseline|Placebo in Parent Study|
333819|NCT00310375|P2|Participant Flow|Retigabine in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm.
333820|NCT00310375|P1|Participant Flow|Placebo in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or Thrice daily [TID]) as an adjunct therapy to their ongoing antiepileptic drugs (AEDs) with or without vagal nerve stimulation (VNS) until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm.
333821|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333822|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333823|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333824|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333825|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333826|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333827|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333828|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333829|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333830|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
334061|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334062|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
333831|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333832|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333833|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333834|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333835|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333836|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333837|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333838|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333839|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333840|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333841|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333842|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333843|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333844|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333845|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333846|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333847|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333848|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333849|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333850|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333851|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333853|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333854|NCT00310375|O1|Outcome|Overall Study|
333855|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333856|NCT00310375|E1|Reported Event|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
333857|NCT00310401|B3|Baseline|Total|Total of all reporting groups
333858|NCT00310401|B2|Baseline|Saline|
333859|NCT00310401|B1|Baseline|Albuterol|
333860|NCT00310401|P2|Participant Flow|Saline|
333861|NCT00310401|P1|Participant Flow|Albuterol|
333862|NCT00310401|O2|Outcome|Saline|
333863|NCT00310401|O1|Outcome|Albuterol|
333864|NCT00310401|E2|Reported Event|Saline|
333865|NCT00310401|E1|Reported Event|Albuterol|
333866|NCT00310427|B3|Baseline|Total|Total of all reporting groups
333867|NCT00310427|B2|Baseline|Placebo|Subjects received placebo orally on a daily basis.
333868|NCT00310427|B1|Baseline|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
333869|NCT00310427|P2|Participant Flow|Placebo|Subjects received placebo orally on a daily basis.
333870|NCT00310427|P1|Participant Flow|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
333871|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
333872|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
333873|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
333874|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
333875|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
333876|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
333877|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
333878|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
333879|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
333880|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
333881|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
333882|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
333886|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
333887|NCT00310427|E2|Reported Event|Placebo|Subjects received placebo orally on a daily basis.
333888|NCT00310427|E1|Reported Event|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
333889|NCT00310440|B3|Baseline|Total|Total of all reporting groups
333890|NCT00310440|B2|Baseline|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
333891|NCT00310440|B1|Baseline|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333892|NCT00310440|P2|Participant Flow|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
333893|NCT00310440|P1|Participant Flow|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333894|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
333895|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333896|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
334009|NCT00297830|B2|Baseline|Placebo Infusion and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
334063|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
333897|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333898|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
333899|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333900|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
333901|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333902|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
333903|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333904|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
333905|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333906|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
339170|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
333907|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333908|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
333909|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333910|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
333911|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333912|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
333913|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333914|NCT00310440|E2|Reported Event|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
333915|NCT00310440|E1|Reported Event|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
333916|NCT00310466|B3|Baseline|Total|Total of all reporting groups
333917|NCT00310466|B2|Baseline|Placebo|Corresponding placebo for sublingual administration
333918|NCT00310466|B1|Baseline|SLITone Birch|Birch pollen extract for sublingual administration
333919|NCT00310466|P2|Participant Flow|Placebo|Corresponding placebo for sublingual administration
333920|NCT00310466|P1|Participant Flow|SLITone Birch|Birch pollen extract for sublingual administration
333921|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
333922|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
333923|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
333924|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
333925|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
333926|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
333927|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
333928|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
333929|NCT00310466|E2|Reported Event|Placebo|Corresponding placebo for sublingual administration
333930|NCT00310466|E1|Reported Event|SLITone Birch|Birch pollen extract for sublingual administration
333931|NCT00297648|B1|Baseline|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333932|NCT00297648|P1|Participant Flow|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333933|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333982|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333983|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333984|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333934|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333935|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333936|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333937|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333938|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333939|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333940|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333941|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333942|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333943|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333944|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333945|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333946|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333985|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333986|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333947|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333948|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333949|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333950|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333951|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333952|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333953|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333954|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333955|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333956|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333957|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333958|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333959|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333987|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333988|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333960|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333961|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333962|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333963|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333964|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333965|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333966|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333967|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333968|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333969|NCT00297648|E1|Reported Event|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
333970|NCT00297778|B3|Baseline|Total|Total of all reporting groups
333971|NCT00297778|B2|Baseline|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333972|NCT00297778|B1|Baseline|Placebo|Placebo tablet matching active treatment
333973|NCT00297778|P2|Participant Flow|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333974|NCT00297778|P1|Participant Flow|Placebo|Placebo tablet matching active treatment
333975|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333976|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333977|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333978|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333979|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333980|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333981|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333989|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333990|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333991|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333992|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333993|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333994|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333995|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333996|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333997|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
333998|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
333999|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
334000|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
334001|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
334002|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
334003|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
334004|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
334005|NCT00297778|E2|Reported Event|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
334006|NCT00297778|E1|Reported Event|Placebo|Placebo tablet matching active treatment
334007|NCT00297830|B4|Baseline|Total|Total of all reporting groups
334008|NCT00297830|B3|Baseline|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
334055|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334056|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334010|NCT00297830|B1|Baseline|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
334011|NCT00297830|P3|Participant Flow|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
334012|NCT00297830|P2|Participant Flow|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
334013|NCT00297830|P1|Participant Flow|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
334014|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
334015|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
334016|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
334017|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
334018|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
334019|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
334020|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
334021|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
334022|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
334023|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
334024|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
334025|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
334026|NCT00297830|E3|Reported Event|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
334027|NCT00297830|E2|Reported Event|Placebo Infusion and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.https://register.clinicaltrials.gov/prs/html/results_definitions.html#Result_ParticipantFlow_Period_title
334028|NCT00297830|E1|Reported Event|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
334029|NCT00303446|B3|Baseline|Total|Total of all reporting groups
334030|NCT00303446|B2|Baseline|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334031|NCT00303446|B1|Baseline|Placebo|Matched placebo, one tablet daily
334032|NCT00303446|P2|Participant Flow|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334033|NCT00303446|P1|Participant Flow|Placebo|Matched placebo, one tablet daily
334034|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334035|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334036|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334037|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334038|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334039|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334040|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334041|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334042|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334043|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334044|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334045|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334046|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334047|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334048|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334049|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334050|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334051|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334052|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334053|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
334054|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334064|NCT00303446|E2|Reported Event|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
334065|NCT00303446|E1|Reported Event|Placebo|Matched placebo, one tablet daily
334066|NCT00303459|B3|Baseline|Total|Total of all reporting groups
334067|NCT00303459|B2|Baseline|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334068|NCT00303459|B1|Baseline|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334069|NCT00303459|P2|Participant Flow|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334070|NCT00303459|P1|Participant Flow|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet, twice a day (b.i.d.) for 4 weeks then bosentan/125 mg tablet/b.i.d."
334071|NCT00303459|O2|Outcome|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334072|NCT00303459|O1|Outcome|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334073|NCT00303459|O2|Outcome|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334074|NCT00303459|O1|Outcome|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334075|NCT00303459|O2|Outcome|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334076|NCT00303459|O1|Outcome|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334077|NCT00303459|O2|Outcome|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334078|NCT00303459|O1|Outcome|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334079|NCT00303459|O2|Outcome|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334080|NCT00303459|O1|Outcome|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet, b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334081|NCT00303459|O2|Outcome|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334082|NCT00303459|O1|Outcome|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334083|NCT00303459|O2|Outcome|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334084|NCT00303459|O1|Outcome|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334085|NCT00303459|O2|Outcome|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334086|NCT00303459|O1|Outcome|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334087|NCT00303459|O2|Outcome|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334088|NCT00303459|O1|Outcome|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334089|NCT00303459|O2|Outcome|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334090|NCT00303459|O1|Outcome|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334091|NCT00303459|E2|Reported Event|Placebo|"Placebo
placebo: Matching bosentan placebo/b.i.d."
334092|NCT00303459|E1|Reported Event|Bosentan|"Bosentan
bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
334093|NCT00303472|B8|Baseline|Total|Total of all reporting groups
334094|NCT00303472|B7|Baseline|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334095|NCT00303472|B6|Baseline|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334096|NCT00303472|B5|Baseline|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334097|NCT00303472|B4|Baseline|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334098|NCT00303472|B3|Baseline|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334099|NCT00303472|B2|Baseline|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334100|NCT00303472|B1|Baseline|Part A: 300 µg Romiplostim|Cohort 1 in Part A, participants received romiplostim 300 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334101|NCT00303472|P7|Participant Flow|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334102|NCT00303472|P6|Participant Flow|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334103|NCT00303472|P5|Participant Flow|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334104|NCT00303472|P4|Participant Flow|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334180|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334105|NCT00303472|P3|Participant Flow|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334106|NCT00303472|P2|Participant Flow|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334107|NCT00303472|P1|Participant Flow|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334108|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334109|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334110|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334111|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334112|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334113|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334114|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334115|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334116|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334117|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334118|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334119|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334120|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334121|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334122|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334123|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334124|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334125|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334126|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334127|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334128|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334129|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334130|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334131|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334132|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334133|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334134|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334135|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334136|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334137|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334138|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334139|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334164|NCT00303485|B3|Baseline|Total|Total of all reporting groups
334140|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334141|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334142|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334143|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334144|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334145|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334146|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334147|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334148|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334149|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334150|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334151|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334152|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334153|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334154|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334155|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334156|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334157|NCT00303472|E7|Reported Event|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
334158|NCT00303472|E6|Reported Event|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
334159|NCT00303472|E5|Reported Event|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334160|NCT00303472|E4|Reported Event|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334161|NCT00303472|E3|Reported Event|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334162|NCT00303472|E2|Reported Event|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334163|NCT00303472|E1|Reported Event|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
334165|NCT00303485|B2|Baseline|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334166|NCT00303485|B1|Baseline|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334167|NCT00303485|P2|Participant Flow|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334168|NCT00303485|P1|Participant Flow|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334169|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334170|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334171|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334172|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334173|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334174|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334175|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334176|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334177|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334178|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334179|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334181|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334182|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334183|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334184|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334185|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334186|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334187|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334188|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334189|NCT00303485|E2|Reported Event|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
334190|NCT00303485|E1|Reported Event|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
334191|NCT00303511|B1|Baseline|ACHD With Pacemaker|
334192|NCT00303511|P1|Participant Flow|ACHD With Pacemaker|
334193|NCT00303511|O1|Outcome|Cohort|
334194|NCT00303511|E1|Reported Event|ACHD With Pacemaker|
334195|NCT00303602|B3|Baseline|Total|Total of all reporting groups
334196|NCT00303602|B2|Baseline|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334197|NCT00303602|B1|Baseline|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334198|NCT00303602|P2|Participant Flow|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334199|NCT00303602|P1|Participant Flow|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334200|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334201|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334202|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334203|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334204|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334205|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334206|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334207|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334208|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334209|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334210|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334211|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334212|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334213|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334214|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334215|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
335112|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
334216|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334217|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334218|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334219|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334220|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334221|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334222|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334223|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334224|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334225|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334226|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334227|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334228|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334229|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334230|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334231|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334232|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334233|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334234|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334235|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334236|NCT00303602|E2|Reported Event|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
334237|NCT00303602|E1|Reported Event|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
334238|NCT00303628|B3|Baseline|Total|Total of all reporting groups
334239|NCT00303628|B2|Baseline|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
bevacizumab: Given IV"
334240|NCT00303628|B1|Baseline|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV"
334241|NCT00303628|P2|Participant Flow|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
bevacizumab: Given IV"
334242|NCT00303628|P1|Participant Flow|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV"
334243|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
bevacizumab: Given IV"
334244|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV"
334245|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
bevacizumab: Given IV"
335113|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
334246|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV"
334247|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
bevacizumab: Given IV"
334248|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV"
334249|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
bevacizumab: Given IV"
334250|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV"
334251|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
bevacizumab: Given IV"
334252|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV"
334253|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
bevacizumab: Given IV"
334254|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.
oxaliplatin: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV"
334255|NCT00303628|E2|Reported Event|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I
334256|NCT00303628|E1|Reported Event|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses* in the absence of disease progression or unacceptable toxicity.
334257|NCT00303667|B3|Baseline|Total|Total of all reporting groups
334258|NCT00303667|B2|Baseline|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334259|NCT00303667|B1|Baseline|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334260|NCT00303667|P2|Participant Flow|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334261|NCT00303667|P1|Participant Flow|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334262|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334263|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334264|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334265|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334297|NCT00303862|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
335114|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
334266|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334267|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334268|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334269|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334270|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334271|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334272|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334273|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334274|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334275|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334276|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334277|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334278|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334279|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334280|NCT00303667|E2|Reported Event|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334281|NCT00303667|E1|Reported Event|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
334282|NCT00303823|B3|Baseline|Total|Total of all reporting groups
334283|NCT00303823|B2|Baseline|Placebo|
334284|NCT00303823|B1|Baseline|Polyphenon E|
334285|NCT00303823|P2|Participant Flow|Placebo|Patients receive oral placebo once daily for 16 weeks
334286|NCT00303823|P1|Participant Flow|Polyphenon E (Defined Green Tea Catechin Extract)|Patients receive oral Polyphenon E daily for 16 weeks
334287|NCT00303823|O2|Outcome|Placebo|
334288|NCT00303823|O1|Outcome|Polyphenon E|
334289|NCT00303823|O2|Outcome|Placebo|
334290|NCT00303823|O1|Outcome|Polyphenon E|
334291|NCT00303823|O2|Outcome|Placebo|
334292|NCT00303823|O1|Outcome|Polyphenon E|
334293|NCT00303823|O2|Outcome|Placebo|
334294|NCT00303823|O1|Outcome|Polyphenon E|
334295|NCT00303823|E2|Reported Event|Placebo|
334296|NCT00303823|E1|Reported Event|Polyphenon E|
334440|NCT00310791|E2|Reported Event|Active|
334298|NCT00303862|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
334299|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
334300|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
334301|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
334302|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
334303|NCT00303862|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
334304|NCT00303901|B1|Baseline|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography"
334305|NCT00303901|P1|Participant Flow|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography"
334306|NCT00303901|O1|Outcome|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography"
334307|NCT00303901|O1|Outcome|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography"
334308|NCT00303901|E1|Reported Event|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography"
334309|NCT00303953|B1|Baseline|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
334310|NCT00303953|P1|Participant Flow|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
334311|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
334312|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
334313|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
334314|NCT00303953|E1|Reported Event|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
334315|NCT00303966|B1|Baseline|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
334316|NCT00303966|P1|Participant Flow|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
334317|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
334318|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
334319|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
334320|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
334321|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
334322|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
334323|NCT00303966|E1|Reported Event|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
334324|NCT00303979|B4|Baseline|Total|Total of all reporting groups
334325|NCT00303979|B3|Baseline|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point
Evidence based guidelines and tools : Education, guidelines, tools"
334326|NCT00303979|B2|Baseline|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point
Evidence based guidelines and tools : Education, guidelines, tools"
334327|NCT00303979|B1|Baseline|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months
Evidence based guidelines and tools : Education, guidelines, tools"
334441|NCT00310791|E1|Reported Event|Placebo|
334328|NCT00303979|P3|Participant Flow|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point
Evidence based guidelines and tools : Education, guidelines, tools"
334329|NCT00303979|P2|Participant Flow|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point
Evidence based guidelines and tools : Education, guidelines, tools"
334330|NCT00303979|P1|Participant Flow|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months
Evidence based guidelines and tools : Education, guidelines, tools"
334331|NCT00303979|O1|Outcome|Cohort C (18 Month)|The number of sites in Cohort C.
334332|NCT00303979|O1|Outcome|Cohort B (6 Month)|Number of sites in Cohort B (6 Month).
334333|NCT00303979|O1|Outcome|Corhort A (Longitudinal)|The number of sites in Cohort A.
334334|NCT00303979|O1|Outcome|Corhort A (Longitudinal)|The number of sites in Cohort A.
334335|NCT00303979|O1|Outcome|Cohort A (Longitudinal)|"For this longitudinal cohort, data are collected at baseline, 12 months and 24 months after the principle investigator and HF nurse attend an educational workshop. All longitudinal analyses will be performed on this cohort of patients. There will be two analysis sets from this cohort:
All Patients: All patients with baseline data Completers: Patients who have a qualifying visit at both baseline and 24 months who were living at the 24 month chart review and are qualified for at least one performance measure at 24 months."
334336|NCT00303979|E3|Reported Event|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point
Evidence based guidelines and tools : Education, guidelines, tools"
334337|NCT00303979|E2|Reported Event|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point
Evidence based guidelines and tools : Education, guidelines, tools"
334338|NCT00303979|E1|Reported Event|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months
Evidence based guidelines and tools : Education, guidelines, tools"
334339|NCT00304031|B4|Baseline|Total|Total of all reporting groups
334340|NCT00304031|B3|Baseline|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
334341|NCT00304031|B2|Baseline|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
334342|NCT00304031|B1|Baseline|No Adjuvant TMZ (Not Randomized )|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
334343|NCT00304031|P3|Participant Flow|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
334344|NCT00304031|P2|Participant Flow|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
334612|NCT00318929|E1|Reported Event|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
334345|NCT00304031|P1|Participant Flow|No Adjuvant TMZ (Not Randomized)|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
334346|NCT00304031|O2|Outcome|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
334347|NCT00304031|O1|Outcome|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
334348|NCT00304031|E3|Reported Event|Dose-dense Adjuvant TMZ|"Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.
Concurrent radiation therapy: 60 Gy in 2 Gy fractions
75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle: Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide."
334349|NCT00304031|E2|Reported Event|Conventional Adjuvant TMZ|"Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.
Concurrent radiation therapy: 60 Gy in 2 Gy fractions
100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle: Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide."
334350|NCT00304031|E1|Reported Event|No Adjuvant TMZ (Not Randomized)|"Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.
Concurrent radiation therapy: 60 Gy in 2 Gy fractions"
334351|NCT00304070|B4|Baseline|Total|Total of all reporting groups
334352|NCT00304070|B3|Baseline|Stratum 3|Stage III OR IV Disease (chemotherapy)
334353|NCT00304070|B2|Baseline|Stratum 2|Stage II Disease (surgery, observation)
334354|NCT00304070|B1|Baseline|Stratum 1|Stage I Disease (surgery, observation)
334355|NCT00304070|P3|Participant Flow|Stratum 3|Stage III OR IV Disease (chemotherapy)
334356|NCT00304070|P2|Participant Flow|Stratum 2|Stage II Disease (surgery, observation)
334357|NCT00304070|P1|Participant Flow|Stratum 1|Stage I Disease (surgery, observation)
334358|NCT00304070|O1|Outcome|All Patients|The number of eligible patients who have surgical resection of the primary tumor and have tumor spillage at the time of resection.
334359|NCT00304070|O1|Outcome|All Patients|Regardless of Arm/Group assignment, the number of eligible patients who had surgery at study enrollment and have A43 del33bp mutation of (beta)-catenins.
334360|NCT00304070|O1|Outcome|All Patients|Regardless of Arm/Group assignment, the number of eligible patients from whom blood was obtained as well as the frequency of the relevant mutation in each group.
334361|NCT00304070|O1|Outcome|All Patients|Regardless of Arm/Group assignment, the frequency reflects the total number of patients who had lymph node involvement by imaging at study enrollment.
334362|NCT00304070|O1|Outcome|All Patients|The complication rate is estimated as the proportion of evaluable patients that have a complication as it relates to surgery.
334363|NCT00304070|O1|Outcome|Stratum 3|Stage III OR IV Disease (chemotherapy)
334364|NCT00304070|O3|Outcome|Stratum 3|Stage III OR IV Disease (chemotherapy)
334365|NCT00304070|O2|Outcome|Stratum 2|Stage II Disease (surgery, observation)
334366|NCT00304070|O1|Outcome|Stratum 1|Stage I Disease (surgery, observation)
334367|NCT00304070|E1|Reported Event|Stratum 3|Stage III OR IV Disease (chemotherapy)
334368|NCT00304096|B3|Baseline|Total|Total of all reporting groups
334369|NCT00304096|B2|Baseline|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
334370|NCT00304096|B1|Baseline|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
334371|NCT00304096|P2|Participant Flow|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
334372|NCT00304096|P1|Participant Flow|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
334373|NCT00304096|O2|Outcome|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
334374|NCT00304096|O1|Outcome|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
334375|NCT00304096|O2|Outcome|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
334376|NCT00304096|O1|Outcome|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
334377|NCT00304096|E2|Reported Event|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
334378|NCT00304096|E1|Reported Event|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
334379|NCT00304161|B3|Baseline|Total|Total of all reporting groups
334380|NCT00304161|B2|Baseline|Placebo|Participants will receive placebo treatment
334381|NCT00304161|B1|Baseline|Atomoxetine|Participants will receive atomoxetine treatment
334382|NCT00304161|P2|Participant Flow|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
334383|NCT00304161|P1|Participant Flow|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
334384|NCT00304161|O2|Outcome|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
334385|NCT00304161|O1|Outcome|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
334386|NCT00304161|O2|Outcome|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
334387|NCT00304161|O1|Outcome|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
334388|NCT00304161|E2|Reported Event|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
334389|NCT00304161|E1|Reported Event|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
334390|NCT00304187|B3|Baseline|Total|Total of all reporting groups
334391|NCT00304187|B2|Baseline|Placebo|"Participants will take matched placebo.
Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
334392|NCT00304187|B1|Baseline|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.
Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
334393|NCT00304187|P2|Participant Flow|Placebo|"Participants will take matched placebo.
Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
334394|NCT00304187|P1|Participant Flow|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.
Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
334395|NCT00304187|O2|Outcome|Placebo|"Participants will take matched placebo.
Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
334396|NCT00304187|O1|Outcome|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.
Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
334397|NCT00304187|E2|Reported Event|Placebo|"Participants will take matched placebo.
Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
334398|NCT00304187|E1|Reported Event|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.
Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
334399|NCT00304265|B3|Baseline|Total|Total of all reporting groups
334400|NCT00304265|B2|Baseline|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
334401|NCT00304265|B1|Baseline|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
334402|NCT00304265|P2|Participant Flow|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
334442|NCT00310804|B3|Baseline|Total|Total of all reporting groups
334443|NCT00310804|B2|Baseline|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
334403|NCT00304265|P1|Participant Flow|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
334404|NCT00304265|O2|Outcome|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
334405|NCT00304265|O1|Outcome|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
334406|NCT00304265|E2|Reported Event|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
334407|NCT00304265|E1|Reported Event|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
334408|NCT00304278|B1|Baseline|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:
Drug: Erlotinib (Tarceva)
150 mg daily X 7 weeks
Other Names:
Tarceva
Drug: Intra-arterial Cisplatin (PLAT)
1 dose (150 mg/sq) per week X 4 weeks
Other Names:
Cisplatin
Radiation: Radiation Therapy (RAD)
5 days per week X 7 weeks
Erlotinib (Tarceva): 150 mg daily X 7 weeks
Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks
Radiation Therapy (RAD): 5 days per week X 7 weeks"
334409|NCT00304278|P1|Participant Flow|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:
Drug: Erlotinib (Tarceva)
150 mg daily X 7 weeks
Other Names:
Tarceva
Drug: Intra-arterial Cisplatin (PLAT)
1 dose (150 mg/sq) per week X 4 weeks
Other Names:
Cisplatin
Radiation: Radiation Therapy (RAD)
5 days per week X 7 weeks
Erlotinib (Tarceva): 150 mg daily X 7 weeks
Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks
Radiation Therapy (RAD): 5 days per week X 7 weeks"
334410|NCT00304278|O1|Outcome|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:
Drug: Erlotinib (Tarceva)
150 mg daily X 7 weeks
Other Names:
Tarceva
Drug: Intra-arterial Cisplatin (PLAT)
1 dose (150 mg/sq) per week X 4 weeks
Other Names:
Cisplatin
Radiation: Radiation Therapy (RAD)
5 days per week X 7 weeks
Erlotinib (Tarceva): 150 mg daily X 7 weeks
Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks
Radiation Therapy (RAD): 5 days per week X 7 weeks"
334411|NCT00304278|O1|Outcome|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:
Drug: Erlotinib (Tarceva)
150 mg daily X 7 weeks
Other Names:
Tarceva
Drug: Intra-arterial Cisplatin (PLAT)
1 dose (150 mg/sq) per week X 4 weeks
Other Names:
Cisplatin
Radiation: Radiation Therapy (RAD)
5 days per week X 7 weeks
Erlotinib (Tarceva): 150 mg daily X 7 weeks
Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks
Radiation Therapy (RAD): 5 days per week X 7 weeks"
334412|NCT00304278|E1|Reported Event|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:
Drug: Erlotinib (Tarceva)
150 mg daily X 7 weeks
Other Names:
Tarceva
Drug: Intra-arterial Cisplatin (PLAT)
1 dose (150 mg/sq) per week X 4 weeks
Other Names:
Cisplatin
Radiation: Radiation Therapy (RAD)
5 days per week X 7 weeks
Erlotinib (Tarceva): 150 mg daily X 7 weeks
Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks
Radiation Therapy (RAD): 5 days per week X 7 weeks"
334413|NCT00304707|B3|Baseline|Total|Total of all reporting groups
334414|NCT00304707|B2|Baseline|Placebo|"placebo
placebo: placebo"
334415|NCT00304707|B1|Baseline|Bupropion 300-mg Capsules|"participants in this arm receive bupropion
Bupropion: 300 mg QD"
334416|NCT00304707|P2|Participant Flow|Placebo|"placebo
placebo: placebo"
334417|NCT00304707|P1|Participant Flow|Bupropion 300-mg Capsules|"participants in this arm receive bupropion
Bupropion: 300 mg QD"
334418|NCT00304707|O2|Outcome|Placebo|"placebo
placebo: placebo"
334419|NCT00304707|O1|Outcome|Bupropion 300-mg Capsules|"participants in this arm receive bupropion
Bupropion: 300 mg QD"
334420|NCT00304707|E2|Reported Event|Placebo|"placebo
placebo: placebo"
334421|NCT00304707|E1|Reported Event|Bupropion 300-mg Capsules|"participants in this arm receive bupropion
Bupropion: 300 mg QD"
334422|NCT00304746|B3|Baseline|Total|Total of all reporting groups
334423|NCT00304746|B2|Baseline|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
334424|NCT00304746|B1|Baseline|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
334425|NCT00304746|P2|Participant Flow|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
334426|NCT00304746|P1|Participant Flow|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
334427|NCT00304746|O2|Outcome|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
334428|NCT00304746|O1|Outcome|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
334429|NCT00304746|O2|Outcome|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
334430|NCT00304746|O1|Outcome|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
334431|NCT00304746|E2|Reported Event|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
334432|NCT00304746|E1|Reported Event|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
334433|NCT00310791|B3|Baseline|Total|Total of all reporting groups
334434|NCT00310791|B2|Baseline|Active|
334435|NCT00310791|B1|Baseline|Placebo|
334436|NCT00310791|P2|Participant Flow|Active|
334437|NCT00310791|P1|Participant Flow|Placebo|
334438|NCT00310791|O2|Outcome|Active|DHEA+HRT
334439|NCT00310791|O1|Outcome|Placebo|Sugar Pill
334444|NCT00310804|B1|Baseline|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
334445|NCT00310804|P2|Participant Flow|TIV Group|Subjects in this group received one dose of Egg derived Trivalent Subunit Influenza Vaccine (TIV).
334446|NCT00310804|P1|Participant Flow|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
334447|NCT00310804|O4|Outcome|TIV Group Day 23 to Day 181|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
334448|NCT00310804|O3|Outcome|TIV Group Day 1 to Day 22|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
334449|NCT00310804|O2|Outcome|cTIV (Combined) Day 23 to Day 181|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
334450|NCT00310804|O1|Outcome|cTIV (Combined) Day 1 to Day 22|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot 1, Lot2 or Lot3).
334451|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
334452|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
334453|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
334454|NCT00310804|O2|Outcome|cTIV_lot2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
334455|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
334456|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
334457|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
334458|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from lot 3.
334459|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
334460|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
334461|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
334462|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
334463|NCT00310804|O3|Outcome|cTIV_lot 3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
334464|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
334465|NCT00310804|O1|Outcome|cTIV_lot 1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
334466|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg-Derived Trivalent Subunit Influenza Vaccine(TIV).
334467|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
334468|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
334469|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
334470|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
334471|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
334472|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
334473|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
334474|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
334475|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell-Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
334476|NCT00310804|E2|Reported Event|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
334477|NCT00310804|E1|Reported Event|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
334478|NCT00310817|B5|Baseline|Total|Total of all reporting groups
334479|NCT00310817|B4|Baseline|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
334480|NCT00310817|B3|Baseline|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
334481|NCT00310817|B2|Baseline|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
334482|NCT00310817|B1|Baseline|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
334483|NCT00310817|P4|Participant Flow|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
334484|NCT00310817|P3|Participant Flow|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
335845|NCT00328172|E5|Reported Event|Metformin|Patients randomized to receive treatment with metformin
334485|NCT00310817|P2|Participant Flow|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
334486|NCT00310817|P1|Participant Flow|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
334487|NCT00310817|O4|Outcome|MenACWY-PS 36 to 59 Months|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
334488|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
334489|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
334490|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
334491|NCT00310817|O4|Outcome|MenACWY-PS 36 to 59 Months|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
334492|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
334493|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
334494|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
334495|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334496|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334497|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334498|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334499|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334500|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334501|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
334502|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
334613|NCT00319020|B3|Baseline|Total|Total of all reporting groups
334503|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
334504|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
334505|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MEnACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
334506|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MEnACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
334507|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
334508|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
334509|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
334510|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
334511|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
334512|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
334513|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
334514|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
334515|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
334516|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
334517|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) (12-35M12- )|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
334518|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
334519|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
334520|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
334521|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
334522|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
334523|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
334524|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
334525|NCT00310817|O2|Outcome|MenACWY-CRM (Ad-)12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334526|NCT00310817|O1|Outcome|MenACWY-CRM (Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334527|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334528|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334529|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334530|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
334531|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
334532|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine with on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
334533|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
334534|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
334535|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
334536|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
334537|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).
334538|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
334539|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
335318|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
334540|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
334541|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).
334542|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) on day 169 (6 months after first vaccination).
334543|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
334544|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
334545|NCT00310817|O4|Outcome|MeMenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
334546|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
334547|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
334548|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
334549|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
334550|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
334551|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
334552|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
334553|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
334554|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
334555|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
334556|NCT00310817|O1|Outcome|MenACWY-CRM(Ad)- (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
334907|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
334557|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
334558|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
334559|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
334560|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
334561|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
334562|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.
334563|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
334564|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337
334565|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.
334566|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.
334567|NCT00310817|E4|Reported Event|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
334568|NCT00310817|E3|Reported Event|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 169 or day 337.
334569|NCT00310817|E2|Reported Event|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
334570|NCT00310817|E1|Reported Event|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+)vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
334571|NCT00310856|B4|Baseline|Total|Total of all reporting groups
334572|NCT00310856|B3|Baseline|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).
Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
334573|NCT00310856|B2|Baseline|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
334574|NCT00310856|B1|Baseline|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
334575|NCT00310856|P3|Participant Flow|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).
Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
334576|NCT00310856|P2|Participant Flow|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).
334577|NCT00310856|P1|Participant Flow|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).
334578|NCT00310856|O3|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).
Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
334579|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
334580|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
334581|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).
Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
334582|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).
Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
334583|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).
Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
334584|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).
Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
334585|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).
Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
334586|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).
Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
337544|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
334587|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
334588|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
334589|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
334590|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
334591|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
334592|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
334593|NCT00310856|E3|Reported Event|MenC-CRM_12M_MenACWY-CRM_18M|Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib- IPV (at 18 months)
334594|NCT00310856|E2|Reported Event|MenACWY-CRM_12M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)
334595|NCT00310856|E1|Reported Event|MenACWY-CRM_6-12M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)
334596|NCT00318812|B3|Baseline|Total|Total of all reporting groups
334597|NCT00318812|B2|Baseline|Iron Sucrose|Iron Sucrose q month IV x 6 months
334598|NCT00318812|B1|Baseline|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
334599|NCT00318812|P2|Participant Flow|Iron Sucrose|Iron Sucrose q month IV x 6 months
334600|NCT00318812|P1|Participant Flow|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
334601|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
334602|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
334603|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
334604|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
334605|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
334606|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
334607|NCT00318812|E2|Reported Event|Iron Sucrose|Iron Sucrose q month IV x 6 months
334608|NCT00318812|E1|Reported Event|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
334609|NCT00318929|B1|Baseline|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
334610|NCT00318929|P1|Participant Flow|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
334611|NCT00318929|O1|Outcome|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
334614|NCT00319020|B2|Baseline|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.
Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
334615|NCT00319020|B1|Baseline|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
334616|NCT00319020|P2|Participant Flow|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.
Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
334617|NCT00319020|P1|Participant Flow|Patients With Previous Bosentan|"This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 (initiatied at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
334618|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
334619|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.
Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
337545|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
334620|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
334621|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
334622|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.
Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
334623|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
334624|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
334625|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.
Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
334626|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
334627|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
334628|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.
Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
334653|NCT00319098|B4|Baseline|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334629|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
334630|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
334631|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.
Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
334632|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
334633|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
334634|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.
Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
334635|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
334636|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
334637|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.
Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
334638|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
334639|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
334640|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.
Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
334641|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
334642|NCT00319020|E3|Reported Event|Single Arm Bosentan_Total|All patients included in Future 1 / FUTURE 2 whether they received bosentan or not bosentan before enrollment in FUTURE 1
334643|NCT00319020|E2|Reported Event|Bosentan_naive Patients|Patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2
334644|NCT00319020|E1|Reported Event|Patients With Previous Bosentan|Patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2
334645|NCT00319046|B1|Baseline|Miglustat|miglustat oral capsules 100mg three times a day
334646|NCT00319046|P1|Participant Flow|Miglustat|miglustat oral capsules 100mg three times a day
334647|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
334648|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
334649|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
334650|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
334651|NCT00319046|E1|Reported Event|Miglustat|miglustat oral capsules 100mg three times a day
334652|NCT00319098|B5|Baseline|Total|Total of all reporting groups
334654|NCT00319098|B3|Baseline|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334655|NCT00319098|B2|Baseline|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334656|NCT00319098|B1|Baseline|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334657|NCT00319098|P2|Participant Flow|Fluarix+Placebo Group|Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses.
334658|NCT00319098|P1|Participant Flow|GSK1562902A Group|Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses.
334659|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334660|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334661|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334662|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334663|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334664|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334665|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334666|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334667|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334668|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334669|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334670|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334671|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334672|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334673|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334674|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334675|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334676|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334677|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334678|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334679|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334680|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334681|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334682|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334683|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
335320|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
334684|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334685|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334686|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334687|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334688|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334689|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334690|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334691|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334692|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334693|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334694|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334695|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334696|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334697|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334698|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334699|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334700|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334701|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334702|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334703|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334704|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334705|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334706|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334707|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334708|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334709|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334710|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334711|NCT00319098|E4|Reported Event|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334712|NCT00319098|E3|Reported Event|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
334713|NCT00319098|E2|Reported Event|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334853|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334714|NCT00319098|E1|Reported Event|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
334715|NCT00319111|B1|Baseline|Bosentan|"Oral bosentan
Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
334716|NCT00319111|P1|Participant Flow|Bosentan|"Oral bosentan
Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
334717|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan
Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
334718|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan
Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
334719|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan
Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
334720|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan
Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
334721|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan
Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
334722|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan
Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
334723|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan
Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
334724|NCT00319111|E1|Reported Event|Bosentan|"Oral bosentan
Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
334725|NCT00319254|B1|Baseline|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334726|NCT00319254|P1|Participant Flow|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334727|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
335150|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
334728|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334729|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334730|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334731|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334732|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334733|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334734|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334735|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334736|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334737|NCT00319254|E1|Reported Event|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
334738|NCT00319436|B3|Baseline|Total|Total of all reporting groups
334739|NCT00319436|B2|Baseline|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
334740|NCT00319436|B1|Baseline|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child’s emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child’s emotional needs.
334741|NCT00319436|P2|Participant Flow|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
334742|NCT00319436|P1|Participant Flow|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
334743|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
335151|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
334744|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
334745|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
334746|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
334747|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
334776|NCT00319501|P1|Participant Flow|Diazepam|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
334854|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
335817|NCT00328094|E2|Reported Event|Intermittent Insulin Bolus|Intermittent insulin boluses group
334748|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
334749|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
334750|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
334751|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
334752|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
334753|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
334754|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
334777|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
334797|NCT00319501|E2|Reported Event|Diazepam (Open-label Period)|Participants received an age- and weight-appropriate dose of placebo solution administered using a spring-driven, pressure-activated, prefilled autoinjector. Additional doses were permissible as needed.
334755|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
334756|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
334757|NCT00319436|E2|Reported Event|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
337546|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
334758|NCT00319436|E1|Reported Event|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child’s emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child’s emotional needs.
334759|NCT00319449|B3|Baseline|Total|Total of all reporting groups
334760|NCT00319449|B2|Baseline|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334761|NCT00319449|B1|Baseline|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334762|NCT00319449|P2|Participant Flow|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334763|NCT00319449|P1|Participant Flow|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334764|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334765|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334766|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334767|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334768|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334769|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334770|NCT00319449|E2|Reported Event|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334771|NCT00319449|E1|Reported Event|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
334772|NCT00319501|B3|Baseline|Total|Total of all reporting groups
334773|NCT00319501|B2|Baseline|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
334774|NCT00319501|B1|Baseline|Diazepam|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
334775|NCT00319501|P2|Participant Flow|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
335024|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
334778|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
334779|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
334780|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
334781|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
334782|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
334783|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
334784|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
334785|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
334786|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
334787|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
334788|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
334789|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
334790|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
334791|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
334792|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
334793|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
334794|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
334795|NCT00319501|E4|Reported Event|Placebo (Double-blind Period)|Participants received a single dose of diazepam-matching solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
334796|NCT00319501|E3|Reported Event|Diazepam (Open-label Extension)|Participants continued to receive diazepam in an age- and weight-appropriate dose of administered using a spring-driven, pressure-activated, prefilled autoinjector. Additional doses were permissible as needed at the onset of an ARS episode. Participants were to continue until drug became marketed.
334852|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334798|NCT00319501|E1|Reported Event|Diazepam (Double-blind Period)|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
334799|NCT00319553|B3|Baseline|Total|Total of all reporting groups
334800|NCT00319553|B2|Baseline|Boostrix® Vaccine Group|
334801|NCT00319553|B1|Baseline|Adacel® Vaccine Group|
334802|NCT00319553|P2|Participant Flow|Boostrix® Vaccine Group|
334803|NCT00319553|P1|Participant Flow|Adacel® Vaccine Group|
334804|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
334805|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
334806|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
334807|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
334808|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
334809|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
334810|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
334811|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
334812|NCT00319553|E2|Reported Event|Boostrix® Vaccine Group|
334813|NCT00319553|E1|Reported Event|Adacel® Vaccine Group|
334814|NCT00319592|B3|Baseline|Total|Total of all reporting groups
334815|NCT00319592|B2|Baseline|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
334816|NCT00319592|B1|Baseline|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
334817|NCT00319592|P2|Participant Flow|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
334818|NCT00319592|P1|Participant Flow|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
334819|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
334820|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
334821|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
334822|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
334823|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
334824|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
334825|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
334826|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
334827|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
334828|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
334829|NCT00319592|E2|Reported Event|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
334830|NCT00319592|E1|Reported Event|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
334831|NCT00319644|B3|Baseline|Total|Total of all reporting groups
334832|NCT00319644|B2|Baseline|Tracheal Aspirates|No intervention. Standard of care in ICU.
334833|NCT00319644|B1|Baseline|Minibal Arm|Using Mini bronchoalveolar lavage
334834|NCT00319644|P2|Participant Flow|Minibal Arm|Using Mini bronchoalveolar lavage
334835|NCT00319644|P1|Participant Flow|Tracheal Aspirates|No intervention. Standard of care in ICU.
334836|NCT00319644|O2|Outcome|Tracheal Aspirates|No intervention. Standard of care in ICU. the aspirates were sent for micro culture.
334837|NCT00319644|O1|Outcome|Mini-BAL|BAL for quantitative culture as TA group.
334838|NCT00319644|O2|Outcome|Tracheal Aspirates|No intervention. Standard of care in ICU. the aspirates were sent for micro culture.
334839|NCT00319644|O1|Outcome|Mini-BAL|BAL for quantitative culture as TA group.
334840|NCT00319644|E2|Reported Event|Tracheal Aspirates|No intervention. Standard of care in ICU.
334841|NCT00319644|E1|Reported Event|Minibal Arm|Using Mini bronchoalveolar lavage
334842|NCT00319696|B1|Baseline|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334843|NCT00319696|P1|Participant Flow|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334844|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334845|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334846|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334847|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334848|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334849|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334850|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334851|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
335025|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
334855|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334856|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334857|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334858|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334859|NCT00319696|O6|Outcome|At Least 5 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
334860|NCT00319696|O5|Outcome|At Least 4 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
334861|NCT00319696|O4|Outcome|At Least 3 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
334862|NCT00319696|O3|Outcome|At Least 2 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
334863|NCT00319696|O2|Outcome|At Least 1 New Ulcer|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
334864|NCT00319696|O1|Outcome|0 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
334865|NCT00319696|E1|Reported Event|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
334866|NCT00319735|B1|Baseline|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334908|NCT00319982|E2|Reported Event|II- Placebo|"Placebo Comparator
Placebo: Placebo comparator (double-blind allocation of study medication)"
334867|NCT00319735|P1|Participant Flow|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334868|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334869|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334870|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334871|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334872|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334873|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.
Subjects who consent will provide tissue samples.
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334874|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334875|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.
Subjects who consent will provide tissue samples.
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334946|NCT00320216|B6|Baseline|Total|Total of all reporting groups
334876|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334877|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.
Subjects who consent will provide tissue samples.
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334878|NCT00319735|E1|Reported Event|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
334879|NCT00319748|B1|Baseline|Patients Treated With 852A Study Drug|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
334880|NCT00319748|P1|Participant Flow|Patients Treated With 852A|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
334881|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of TNF-a in patients treated with 852A.
334882|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of sCD40L in patients treated with 852A.
334883|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of MIP-1b in patients treated with 852A.
334884|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for Macrophage Inflammatory Protein-1 Alpha (cytokine) level in patients treated with 852A.
334885|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of IP-10 in patients treated with 852A.
334886|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of IL1ra in patients treated with 852A.
334887|NCT00319748|O1|Outcome|Patients With Ovarian Cancer|Participants with ovarian cancer who received all 24 doses of 852A.
334888|NCT00319748|E1|Reported Event|Patients Treated With 852A Study Drug|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
334889|NCT00319982|B3|Baseline|Total|Total of all reporting groups
334890|NCT00319982|B2|Baseline|II- Placebo|"Placebo Comparator
Placebo: Placebo comparator (double-blind allocation of study medication)"
334891|NCT00319982|B1|Baseline|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
334892|NCT00319982|P2|Participant Flow|II- Placebo|"Placebo Comparator
Placebo: Placebo comparator (double-blind allocation of study medication)"
334893|NCT00319982|P1|Participant Flow|I- Diltiazem (Active Arm)|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
334894|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator
Placebo: Placebo comparator (double-blind allocation of study medication)"
334895|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
334896|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator
Placebo: Placebo comparator (double-blind allocation of study medication)"
334897|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
334898|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator
Placebo: Placebo comparator (double-blind allocation of study medication)"
334899|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
334900|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator
Placebo: Placebo comparator (double-blind allocation of study medication)"
334901|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
334902|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator
Placebo: Placebo comparator (double-blind allocation of study medication)"
334903|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
334904|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator
Placebo: Placebo comparator (double-blind allocation of study medication)"
334905|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
334906|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator
Placebo: Placebo comparator (double-blind allocation of study medication)"
334909|NCT00319982|E1|Reported Event|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
334910|NCT00320112|B3|Baseline|Total|Total of all reporting groups
334911|NCT00320112|B2|Baseline|Nurse Case Management|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
334912|NCT00320112|B1|Baseline|Receiprocal Peer Support|"participants in the intervention arm are paired with a peer
Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.
group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
334913|NCT00320112|P2|Participant Flow|Nurse Case Management|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts. particpants were also provided information about nurse case managements services and encouraged to use the service regularly.
334914|NCT00320112|P1|Participant Flow|Reciprocal Diabetes Peer Support Program (RPS)|"participants in the intervention arm are paired with a peer
Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.
group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
334915|NCT00320112|O2|Outcome|Nurse Case Management Grouop|patients were provided an educational session and discussed nurse case management services. participants were encouraged to meet wit their case manager regularly.
334916|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|patients were age-matched and assigned to a peer. they were asked to make weekly calls using a telephone support system to check in and discuss their diabetes
334917|NCT00320112|O2|Outcome|Nurse Case Management Group|participants in the nurse case management group receive initial educational session on diabetes and information bout case management services. they are encouraged to contact their nurse case manager regularly.
334918|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|participants are age-matched with a peer and asked to talk with each other weekly using a telephone support sytem
334919|NCT00320112|O2|Outcome|Change in Systsolic at 6 Months for Nurse Mgt Group|change in systolic blood pressure from baseline to six months in the nurse case management group
334920|NCT00320112|O1|Outcome|Change in Systolic BP at 6 Months for Peer Support Group|change in systolic blood pressure from baseline to six months among participants in the peer support group
334921|NCT00320112|O2|Outcome|Nurse Case Management Group|Nurse Case Management group was offered an educational session with nurse case managers on diabetes and informed of case management services. they were encouraged to utilize this service regularly.
334922|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|"participants in the intervention arm are paired with a peer
Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.
group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
334923|NCT00320112|E2|Reported Event|Nurse Case Management Intervention|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
335818|NCT00328094|E1|Reported Event|Continuous Insulin Infusion|Tight glucose group with insulin infusion
334924|NCT00320112|E1|Reported Event|Reciprocal Peer Support Intervention|"participants in the intervention arm are paired with a peer
Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.
group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
334925|NCT00320190|B3|Baseline|Total|Total of all reporting groups
334926|NCT00320190|B2|Baseline|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
334927|NCT00320190|B1|Baseline|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
334928|NCT00320190|P2|Participant Flow|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
334929|NCT00320190|P1|Participant Flow|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
334930|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
334931|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
334932|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
334933|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
334934|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
334935|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
334936|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
334937|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
334938|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
334939|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
334940|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
334941|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
334942|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
334943|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
334944|NCT00320190|E2|Reported Event|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily
334945|NCT00320190|E1|Reported Event|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
334947|NCT00320216|B5|Baseline|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334948|NCT00320216|B4|Baseline|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334949|NCT00320216|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334950|NCT00320216|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334951|NCT00320216|B1|Baseline|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
334952|NCT00320216|P5|Participant Flow|Ustekinumab 90 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
334953|NCT00320216|P4|Participant Flow|Ustekinumab 45 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
334954|NCT00320216|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
334955|NCT00320216|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
334956|NCT00320216|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.
334957|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334958|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334959|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334960|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334961|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
334962|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334963|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334964|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334965|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334966|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
334967|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334968|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334969|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334970|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334971|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
334972|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334973|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334974|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334975|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
334976|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
334977|NCT00320216|E10|Reported Event|Ustekinumab 90 mg Weekly for 4 Weeks (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg.
334978|NCT00320216|E9|Reported Event|Ustekinumab 45 mg Weekly for 4 Weeks (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg.
334979|NCT00320216|E8|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg.
334980|NCT00320216|E7|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg.
334981|NCT00320216|E6|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 20-36) - receiving placebo at Weeks 0, 1, 2, 3 and 16 -> receiving ustekinumab 90 mg at Week 20.
334982|NCT00320216|E5|Reported Event|Ustekinumab 90 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
334983|NCT00320216|E4|Reported Event|Ustekinumab 45 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
334984|NCT00320216|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
334985|NCT00320216|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
334986|NCT00320216|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.
334987|NCT00320242|B1|Baseline|All Study Participants Who Completed Protocol|This analysis includes all study participants who completed the protocol (n = 26)
335819|NCT00328172|B6|Baseline|Total|Total of all reporting groups
334988|NCT00320242|P2|Participant Flow|2 Month Baseline Before Visual Cue|2 month baseline using the laserlight visual cue, followed by 1 additional month using the laserlight visual cue. This group served as an active comparator control for comparison with Group 1during the 2nd month, when group 1 did use the visual cue but group 2 continued without the visual cue.
334989|NCT00320242|P1|Participant Flow|1 mo Baseline Before Visual Cue|1 mo baseline using the cane/walker without the laserlight visual cue, followed by additional time using the visual cue
334990|NCT00320242|O1|Outcome|1 or 2 Month Baseline Before Use of Laserlight Visual Cue|subjects had a 1 month baseline before use of laserlight visual cue
334991|NCT00320242|O1|Outcome|All Study Participants Who Completed Protocol|All 26 Study Participants who completed protocol. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue.
334992|NCT00320242|O1|Outcome|All Study Participants Who Completed Protocol|All 26 subjects who entered the study and completed the study protocol.
334993|NCT00320242|O1|Outcome|1 Month Baseline Before Use of Laserlight Visual Cue|subjects had a 1 month baseline before use of laserlight visual cue
334994|NCT00320242|E1|Reported Event|All Study Participants|
334995|NCT00320255|B7|Baseline|Total|Total of all reporting groups
334996|NCT00320255|B6|Baseline|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
334997|NCT00320255|B5|Baseline|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
334998|NCT00320255|B4|Baseline|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
334999|NCT00320255|B3|Baseline|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335000|NCT00320255|B2|Baseline|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335001|NCT00320255|B1|Baseline|Cohort 1: Placebo|Participants received placebo tablets once daily
335002|NCT00320255|P6|Participant Flow|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335003|NCT00320255|P5|Participant Flow|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335004|NCT00320255|P4|Participant Flow|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335005|NCT00320255|P3|Participant Flow|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335006|NCT00320255|P2|Participant Flow|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335007|NCT00320255|P1|Participant Flow|Cohort 1: Placebo|Participants received placebo tablets once daily
335008|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335009|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335010|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335011|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335012|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335013|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
335014|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335015|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335016|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335017|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335018|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335019|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
335020|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335021|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335022|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335023|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335820|NCT00328172|B5|Baseline|Metformin|Patients randomized to receive treatment with metformin
335026|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335027|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335028|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335029|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335030|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335031|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
335032|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335033|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335034|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335035|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335036|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335037|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
335038|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335111|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
335039|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335040|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335041|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335042|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335043|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
335044|NCT00320255|O6|Outcome|Cohort 2: Apixiban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335045|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335046|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335047|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335048|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335049|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
335050|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335051|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335052|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335053|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335054|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335055|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
335056|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335057|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335058|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335059|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335060|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335061|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
335319|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335062|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335063|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335064|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335065|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335066|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335067|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
335068|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335069|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335070|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335071|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335072|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335073|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
335074|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335075|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335076|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335077|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335078|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335079|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
335080|NCT00320255|E6|Reported Event|Cohort : Apixaban, 5 mg|:Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
335081|NCT00320255|E5|Reported Event|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
335082|NCT00320255|E4|Reported Event|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
335083|NCT00320255|E3|Reported Event|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
335084|NCT00320255|E2|Reported Event|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
335085|NCT00320255|E1|Reported Event|Cohort 1: Placebo|Participants received placebo tablets once daily
335086|NCT00320281|B3|Baseline|Total|Total of all reporting groups
335087|NCT00320281|B2|Baseline|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
335088|NCT00320281|B1|Baseline|Group 1-Botox A Group|This group received the active drug, botox a injections.
335089|NCT00320281|P2|Participant Flow|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
335090|NCT00320281|P1|Participant Flow|Group 1-Botox A Group|This group received the active drug, botox a injections.
335091|NCT00320281|O2|Outcome|Group 2-saline Group|Those randomized to this treatment group received injections based on treatment plan devised by study PI and study physical therapist. 25 cc of saline were used for these injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
335092|NCT00320281|O1|Outcome|Group 1-Botox A Group|Those randomized to this treatment group received injections based on treatment plan designed by PI and study physical therapist. Botulism toxin A was diluted in 25 cc of saline for the injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
335093|NCT00320281|E2|Reported Event|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
335094|NCT00320281|E1|Reported Event|Group 1-Botox A Group|This group received the active drug, botox a injections.
335095|NCT00320372|B4|Baseline|Total|Total of all reporting groups
335096|NCT00320372|B3|Baseline|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy. Subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the TAU study arm.
335176|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335097|NCT00320372|B2|Baseline|VNS Therapy D-21 Rollover|Subjects that entered the TRD Registry, having previously participated in the D-21 study and still being treated with VNS Therapy treatment were included within the VNS Therapy group. Based on the duration from initial implant to enrollment date, the D-21 rollover patients entered at the appropriate D-23 follow-up interval (i.e., patient enrolls at 24 months post implant for their first D-23 follow up visit. This 24 month visit corresponds to the 24 month follow up in the TRD Registry). Starting with the first TRD Registry visit, the D-21 long-term patients were to follow the same data collection schedule as other Original VNS and TAU Registry patients.
335098|NCT00320372|B1|Baseline|VNS Therapy D-23 Original|Subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the VNS Therapy study arm.
335099|NCT00320372|P2|Participant Flow|Treatment as Usual (TAU)|Disposition of study patients from baseline to the end of the study. The TAU arm were subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the TAU study arm.
335100|NCT00320372|P1|Participant Flow|VNS Therapy|Disposition of study patients from baseline to the end of the study. The VNS Therapy arm, was comprised of D-23 Original patients (Patients that entered the TRD Registry without previous VNS Therapy treatment and selected the VNS Therapy study arm) and D-21 Rollover patients (Patients that entered the TRD Registry, having previously participated in the D-21 study-NCT00305565 and still being treated with VNS Therapy).
335101|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
335102|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
335103|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
335104|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|Change from Baseline Score
335105|NCT00320372|O1|Outcome|VNS Therapy|Change from Baseline Score
335106|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
335107|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
335108|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
335109|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
335110|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
335115|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
335116|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
335117|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|MADRS % Remitters (Percentage of Subjects in Remission)
335118|NCT00320372|O1|Outcome|VNS Therapy|MADRS % Remitters (Percentage of Subjects in Remission)
335119|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|Time until recurrence based on the MADRS
335120|NCT00320372|O1|Outcome|VNS Therapy|Time until recurrence based on the MADRS
335121|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|MADRS % Responders (Percentage of Responders)
335122|NCT00320372|O1|Outcome|VNS Therapy|MADRS % Responders (Percentage of Responders)
335123|NCT00320372|E1|Reported Event|Safety Events|N/A (not collected)
335124|NCT00320385|B3|Baseline|Total|Total of all reporting groups
335125|NCT00320385|B2|Baseline|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
335126|NCT00320385|B1|Baseline|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
335127|NCT00320385|P2|Participant Flow|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
335128|NCT00320385|P1|Participant Flow|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
335129|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
335130|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
335131|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
335132|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
335133|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
335134|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
335135|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
335315|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335136|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
335137|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
335138|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
335139|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
335140|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
335141|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
335142|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
335143|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
335144|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
335145|NCT00320385|E2|Reported Event|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
335146|NCT00320385|E1|Reported Event|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
335147|NCT00320411|B1|Baseline|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335148|NCT00320411|P1|Participant Flow|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335149|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335152|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335153|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335154|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335155|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335156|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335157|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335158|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335159|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335160|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335161|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335162|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335163|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335164|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335165|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335166|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335167|NCT00320411|E1|Reported Event|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
335168|NCT00320489|B3|Baseline|Total|Total of all reporting groups
335169|NCT00320489|B2|Baseline|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335170|NCT00320489|B1|Baseline|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335171|NCT00320489|P2|Participant Flow|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335172|NCT00320489|P1|Participant Flow|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335173|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335174|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335175|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335177|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335178|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335179|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335180|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335181|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335182|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335183|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335184|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335185|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335186|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335187|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335188|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335189|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335190|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335191|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335192|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335193|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335194|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335195|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335196|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335197|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335198|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335199|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335200|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335201|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335202|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335203|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335204|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335205|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335206|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335207|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335208|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335209|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335210|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335211|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335212|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335213|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335214|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335215|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335216|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335217|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335218|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335219|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335220|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335221|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335407|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
335408|NCT00320788|O6|Outcome|Total|
335222|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335223|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335224|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335225|NCT00320489|E2|Reported Event|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
335226|NCT00320489|E1|Reported Event|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
335227|NCT00320515|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
335228|NCT00320515|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
335229|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
335230|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
335231|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
335232|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
335233|NCT00320515|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
335234|NCT00320528|B4|Baseline|Total|Total of all reporting groups
335235|NCT00320528|B3|Baseline|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335236|NCT00320528|B2|Baseline|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335237|NCT00320528|B1|Baseline|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335316|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
335238|NCT00320528|P3|Participant Flow|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335239|NCT00320528|P2|Participant Flow|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335240|NCT00320528|P1|Participant Flow|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335241|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335242|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335243|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335244|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335245|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335246|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335247|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335409|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0mg of aflibercept injection at 12 week intervals through Week 12.
335248|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335249|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335250|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335251|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335252|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335253|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335254|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335255|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335256|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335257|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335258|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335259|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335260|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335261|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335262|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335263|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335264|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335265|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335266|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335267|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335268|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335269|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335270|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335271|NCT00320528|E3|Reported Event|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335272|NCT00320528|E2|Reported Event|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335273|NCT00320528|E1|Reported Event|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
335274|NCT00320541|B3|Baseline|Total|Total of all reporting groups
335275|NCT00320541|B2|Baseline|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335276|NCT00320541|B1|Baseline|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335277|NCT00320541|P2|Participant Flow|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335278|NCT00320541|P1|Participant Flow|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335279|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335280|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335281|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335282|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335283|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335317|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335284|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335285|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335286|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335287|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335288|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335289|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335290|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335291|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335292|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335367|NCT00320749|P2|Participant Flow|Dose Level 2|Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
335293|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335294|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335295|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335296|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335297|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335298|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335299|NCT00320541|E2|Reported Event|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335300|NCT00320541|E1|Reported Event|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
335301|NCT00320593|B3|Baseline|Total|Total of all reporting groups
335302|NCT00320593|B2|Baseline|Single Vision Lenses (SVLs)|Standard single vision lenses
335303|NCT00320593|B1|Baseline|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335304|NCT00320593|P2|Participant Flow|Single Vision Lenses (SVLs)|Standard single vision lenses
335305|NCT00320593|P1|Participant Flow|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335306|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
335307|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335308|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
335309|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335310|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
335311|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335312|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
335313|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335314|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
335321|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335322|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
335323|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335324|NCT00320593|E2|Reported Event|Single Vision Lenses (SVLs)|Standard single vision lenses
335325|NCT00320593|E1|Reported Event|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
335326|NCT00320606|B1|Baseline|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
335327|NCT00320606|P1|Participant Flow|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
335328|NCT00320606|O1|Outcome|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
335329|NCT00320606|E1|Reported Event|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
335330|NCT00320671|B3|Baseline|Total|Total of all reporting groups
335331|NCT00320671|B2|Baseline|Participants Will Take Risperidone|"Participants will take risperidone
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end."
335332|NCT00320671|B1|Baseline|Participants Will Take Aripiprazole|"Participants will take aripiprazole
Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end."
335333|NCT00320671|P2|Participant Flow|Participants Will Take Risperidone Arm 2|-96 participants were randomized to to Arm 2
335334|NCT00320671|P1|Participant Flow|Participants Will Take Aripiprazole Arm 1|-102 were allocated to Arm 1.
335335|NCT00320671|O2|Outcome|Percentage of Participants That Reposonded to Risperidone|Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
335336|NCT00320671|O1|Outcome|Percentage of Participants That Reposonded to Aripiprazole|Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
335337|NCT00320671|E2|Reported Event|Participants Will Take Risperidone|Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
335338|NCT00320671|E1|Reported Event|Participants Will Take Aripiprazole|Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
335339|NCT00320710|B4|Baseline|Total|Total of all reporting groups
335340|NCT00320710|B3|Baseline|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
335341|NCT00320710|B2|Baseline|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
335342|NCT00320710|B1|Baseline|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
335343|NCT00320710|P3|Participant Flow|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
335344|NCT00320710|P2|Participant Flow|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
335345|NCT00320710|P1|Participant Flow|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
335346|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
335347|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
335348|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
335349|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
335350|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
335351|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
335352|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
335353|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
338557|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
335354|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
335355|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
335356|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
335357|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
335358|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
335359|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
335360|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
335361|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
335362|NCT00320710|E3|Reported Event|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
335363|NCT00320710|E2|Reported Event|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
335364|NCT00320710|E1|Reported Event|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
335365|NCT00320749|B1|Baseline|Capecitabine, Gemcitabine and Docetaxel|Docetaxel i.v. over 30 min on days 1 and 8; Capecitabine p.o. in split doses bid on days 8-21, Gemcitabine i.v. over 75 min on days 8 and 15.
335366|NCT00320749|P3|Participant Flow|Dose Level 3|Docetaxel at 36 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
335516|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335368|NCT00320749|P1|Participant Flow|Dose Level 1|Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 500 mg/m2/12 hours on days 8-21
335369|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
335370|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
335371|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|"Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
Capecitabine: Will be give on days 8-21
Docetaxel: Will be given on days 1 and 8,
Gemcitabine: A fixed dose rate will be give on days 8 and 15."
335372|NCT00320749|E1|Reported Event|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
335373|NCT00320788|B6|Baseline|Total|Total of all reporting groups
335374|NCT00320788|B5|Baseline|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
335375|NCT00320788|B4|Baseline|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
335376|NCT00320788|B3|Baseline|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
335377|NCT00320788|B2|Baseline|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
335378|NCT00320788|B1|Baseline|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
335379|NCT00320788|P5|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12|Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
335380|NCT00320788|P4|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
335381|NCT00320788|P3|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
335382|NCT00320788|P2|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
335383|NCT00320788|P1|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
335384|NCT00320788|O6|Outcome|Total|
335385|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
335386|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
335387|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
335388|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
335389|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
335390|NCT00320788|O6|Outcome|Total|
335391|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0mg of aflibercept injection at 12 week intervals through Week 12.
335392|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0mg of aflibercept injection at 12 week intervals through Week 12.
335393|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0mg of aflibercept injection at 4 week intervals through Week 12.
335394|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
335395|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
335396|NCT00320788|O6|Outcome|Total|
335397|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
335398|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
335399|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
335400|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
335401|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
335402|NCT00320788|O6|Outcome|Total|
335403|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
335404|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
335405|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
335406|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
335410|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0mg of aflibercept injection at 12 week intervals through Week 12.
335411|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0mg of aflibercept injection at 4 week intervals through Week 12.
335412|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5mg of aflibercept injection at 12 week intervals through Week 12.
335413|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5mg of aflibercept injection at 4 week intervals through Week 12.
335414|NCT00320788|O6|Outcome|Total|
335415|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
335416|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
335417|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
335418|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
335419|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
335420|NCT00320788|E5|Reported Event|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
335421|NCT00320788|E4|Reported Event|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
335422|NCT00320788|E3|Reported Event|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
335423|NCT00320788|E2|Reported Event|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
335424|NCT00320788|E1|Reported Event|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
335425|NCT00320801|B3|Baseline|Total|Total of all reporting groups
335426|NCT00320801|B2|Baseline|Double-blind BTDS 20|Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
335427|NCT00320801|B1|Baseline|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
335428|NCT00320801|P4|Participant Flow|Extension Phase|Subjects received open-label buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear for up to 52 weeks.
335429|NCT00320801|P3|Participant Flow|Double-blind BTDS 20|Test treatment: buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
335430|NCT00320801|P2|Participant Flow|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
335431|NCT00320801|P1|Participant Flow|Run-in Period|(≤14 days). The run-in period was designed to select subjects who tolerated and responded to BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
335432|NCT00320801|O4|Outcome|Overall BTDS Exposure|Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
335433|NCT00320801|O3|Outcome|Run-in Period|The run-in period was designed to determine tolerability of BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
338558|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
335434|NCT00320801|O2|Outcome|Double-blind BTDS 20|Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
335435|NCT00320801|O1|Outcome|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
335436|NCT00320801|E4|Reported Event|Overall BTDS Exposure|Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
335437|NCT00320801|E3|Reported Event|Open-label Run-in Period|The run-in period (14 days) was designed to identify subjects whose pain was controlled with and who tolerated BTDS 20. Open-label BTDS 10 or 20 mcg/h applied for 7-day wear to qualify for randomization into the double-blind phase.
335438|NCT00320801|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
335439|NCT00320801|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
335440|NCT00321269|B3|Baseline|Total|Total of all reporting groups
335441|NCT00321269|B2|Baseline|8-Week Phone-based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping
CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
335442|NCT00321269|B1|Baseline|8-week Phone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure
Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
335443|NCT00321269|P2|Participant Flow|8-week Phone Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping
CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
335444|NCT00321269|P1|Participant Flow|8-week Phone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure
Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
335445|NCT00321269|O2|Outcome|8-Week Phone-Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping
CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
335446|NCT00321269|O1|Outcome|8-Week Phone-Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure
Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
335447|NCT00321269|O2|Outcome|8-week Phone-based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping
CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
335448|NCT00321269|O1|Outcome|8-week Phone-based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure
Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
335449|NCT00321269|E2|Reported Event|8-Week Phone Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping
CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
335450|NCT00321269|E1|Reported Event|8-week Telephone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure
Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
335451|NCT00307684|B1|Baseline|Overall Study Population|Prolonged release (PR) Osmotic Release Oral Systems (OROS) MPH 18 to 90 mg once daily during the OL phase. Subjects who had received at 52 weeks of uninterrupted treatment with PR OROS MPH and provided consent for the DB phase were randomly assigned to placebo or their previous dose of PR OROS MPH (18 to 90 mg once daily)
335452|NCT00307684|P3|Participant Flow|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
335453|NCT00307684|P2|Participant Flow|Placebo|matching placebo
335454|NCT00307684|P1|Participant Flow|Active|PR OROS MPH 18 to 90 mg once daily
335455|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
335456|NCT00307684|O2|Outcome|Placebo|matching placebo
335457|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
335458|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
335459|NCT00307684|O2|Outcome|Placebo|matching placebo
335460|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
335461|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
335462|NCT00307684|O2|Outcome|Placebo|matching placebo
335463|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
335464|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
335465|NCT00307684|O2|Outcome|Placebo|matching placebo
335466|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
335467|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
335468|NCT00307684|O2|Outcome|Placebo|matching placebo
335469|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
335470|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
335471|NCT00307684|O2|Outcome|Placebo|matching placebo
335472|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
335473|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
335474|NCT00307684|O2|Outcome|Placebo|matching placebo
335475|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
335476|NCT00307684|E3|Reported Event|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
335477|NCT00307684|E2|Reported Event|Placebo|matching placebo
335478|NCT00307684|E1|Reported Event|Active|PR OROS MPH 18 to 90 mg once daily
335479|NCT00307736|B1|Baseline|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|All patients receive chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib.
335501|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335480|NCT00307736|P4|Participant Flow|Phase II (100mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
335481|NCT00307736|P3|Participant Flow|Phase 1 (150mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
335482|NCT00307736|P2|Participant Flow|Phase 1 (100mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
335483|NCT00307736|P1|Participant Flow|Phase 1 (Erlotinib 50mg)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
335484|NCT00307736|O3|Outcome|Treated at MTD|"Patients who were treated with erlotinib at maximum tolerated dose, along with standard study therapy.
All patients receive chemoradiation with continuous infusion of 5-fluorouracil, bevacizumab and erlotinib."
335485|NCT00307736|O2|Outcome|Underwent Resection|"Patients who underwent R0 resection following study therapy
All patients receive chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib."
335486|NCT00307736|O1|Outcome|Completed Study Therapy|"Patients who had pathologic complete response following completion of study therapy.
All patients receive chemo-radiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib."
335517|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335518|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335846|NCT00328172|E4|Reported Event|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
335487|NCT00307736|O1|Outcome|Surgery, 5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Patients undergoing R0 resection following chemotherapy and radiation.
Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
335488|NCT00307736|O1|Outcome|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
335489|NCT00307736|O2|Outcome|Grade 4|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
335490|NCT00307736|O1|Outcome|Grade 3|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
335491|NCT00307736|O1|Outcome|5-FU, Bevacizumab, Erlotinib and Radiation|All patients received chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib. (phase 1 participants)
335492|NCT00307736|E1|Reported Event|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.
5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
335493|NCT00307801|B3|Baseline|Total|Total of all reporting groups
335494|NCT00307801|B2|Baseline|Placebo|Matching placebo to be taken orally daily.
335495|NCT00307801|B1|Baseline|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335496|NCT00307801|P2|Participant Flow|Placebo|Matching placebo to be taken orally daily
335497|NCT00307801|P1|Participant Flow|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335498|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
335499|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335500|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
335502|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335503|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335504|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335505|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335506|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335507|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335508|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335509|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335510|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335511|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335512|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335513|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335514|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335515|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335519|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335520|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335521|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335522|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335523|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335524|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335525|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335526|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335527|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335528|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335529|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335530|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335531|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335532|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335533|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335534|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335535|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335536|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335637|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
335638|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
335537|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335538|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335539|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335540|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335541|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335542|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335543|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335544|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335545|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335546|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335547|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335548|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335549|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335550|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335551|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335552|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335553|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335554|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335555|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335556|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335557|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335558|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335559|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335560|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335561|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335562|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335563|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335564|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335565|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335566|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335567|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335568|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335569|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335570|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335639|NCT00308074|E1|Reported Event|Aripiprazole|aripiprazole monotherapy
335640|NCT00308087|B3|Baseline|Total|Total of all reporting groups
335571|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335572|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335573|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335574|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335575|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335576|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335577|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335578|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335579|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335580|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335581|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335582|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335583|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335584|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335585|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335586|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335587|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335588|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335589|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335590|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335591|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335592|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335593|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335594|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335595|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335596|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335597|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335598|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335599|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335600|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335601|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335602|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
335603|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335604|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
335712|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
338559|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
335605|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335606|NCT00307801|E2|Reported Event|Placebo|Matching placebo to be taken orally daily
335607|NCT00307801|E1|Reported Event|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
335608|NCT00307931|B1|Baseline|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335609|NCT00307931|P1|Participant Flow|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335610|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335611|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335612|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335613|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335614|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335615|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335616|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335617|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335618|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335619|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335620|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335621|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335622|NCT00307931|E1|Reported Event|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
335623|NCT00308061|B3|Baseline|Total|Total of all reporting groups
335624|NCT00308061|B2|Baseline|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
335625|NCT00308061|B1|Baseline|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
335626|NCT00308061|P2|Participant Flow|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
335627|NCT00308061|P1|Participant Flow|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
335628|NCT00308061|O1|Outcome|Geometric Mean Titer|Geometric Mean Titer (GMT)
335629|NCT00308061|O2|Outcome|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
335630|NCT00308061|O1|Outcome|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
335631|NCT00308061|E2|Reported Event|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
335632|NCT00308061|E1|Reported Event|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
335633|NCT00308074|B1|Baseline|Aripiprazole|aripiprazole monotherapy
335634|NCT00308074|P1|Participant Flow|Aripiprazole|"aripiprazole monotherapy
Aripiprazole will be started at 2.5 or 5mg depending on clinical impression and severity of aggression and agitation. The dose will be evaluated weekly, according to clinical impression and adjusted if deemed appropriate, in not more than 5mg increments . The lowest effective dose will be used."
335635|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
335636|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
335641|NCT00308087|B2|Baseline|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
335642|NCT00308087|B1|Baseline|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
335643|NCT00308087|P2|Participant Flow|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
335644|NCT00308087|P1|Participant Flow|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
335645|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
335646|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
335647|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
335648|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
335649|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
335650|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
335651|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
335652|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
335653|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
335654|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
335837|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
335655|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
335656|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
335657|NCT00308087|E2|Reported Event|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
335658|NCT00308087|E1|Reported Event|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
335659|NCT00321321|B1|Baseline|Sulfonylurea|
335660|NCT00321321|P1|Participant Flow|Sulfonylurea|
335661|NCT00321321|O1|Outcome|Sulfonylurea|
335662|NCT00321321|E1|Reported Event|Sulfonylurea|Sulfonylurea-treated patients
335663|NCT00321373|B4|Baseline|Total|Total of all reporting groups
335664|NCT00321373|B3|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335665|NCT00321373|B2|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335666|NCT00321373|B1|Baseline|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335667|NCT00321373|P3|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335668|NCT00321373|P2|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335669|NCT00321373|P1|Participant Flow|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335670|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335671|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335672|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335673|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335674|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335675|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335676|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335677|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335678|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335679|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335680|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335681|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335682|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335683|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335684|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335685|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335838|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
335686|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335687|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335688|NCT00321373|E3|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335689|NCT00321373|E2|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335690|NCT00321373|E1|Reported Event|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
335691|NCT00321464|B3|Baseline|Total|Total of all reporting groups
335692|NCT00321464|B2|Baseline|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
335693|NCT00321464|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
335694|NCT00321464|P2|Participant Flow|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
335695|NCT00321464|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
335696|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
335697|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
335698|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
335699|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
335700|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
335701|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
335702|NCT00321464|E2|Reported Event|Denosumab 120 mg Q4W|
335703|NCT00321464|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
335704|NCT00321620|B3|Baseline|Total|Total of all reporting groups
335705|NCT00321620|B2|Baseline|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
335706|NCT00321620|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
335707|NCT00321620|P2|Participant Flow|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
335708|NCT00321620|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
335709|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
335710|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
335711|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
335814|NCT00328094|O1|Outcome|Continuous Insulin Infusion|Tight glucose group with insulin infusion
335713|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
335714|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
335715|NCT00321620|E2|Reported Event|Denosumab 120 mg Q4W|
335716|NCT00321620|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
335717|NCT00327392|B1|Baseline|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
335718|NCT00327392|P1|Participant Flow|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
335719|NCT00327392|O1|Outcome|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
335720|NCT00327392|E1|Reported Event|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
335721|NCT00327444|B3|Baseline|Total|Total of all reporting groups
335722|NCT00327444|B2|Baseline|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
335723|NCT00327444|B1|Baseline|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
335724|NCT00327444|P2|Participant Flow|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
335839|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
335840|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
335725|NCT00327444|P1|Participant Flow|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
335726|NCT00327444|O2|Outcome|Open-Label (OL) Period|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
335727|NCT00327444|O1|Outcome|Double Blind (DB) Period|Participants with advanced ovarian cancer administered placebo or 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period.
335728|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
335729|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
335730|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
335731|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
335732|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
335733|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
335734|NCT00327444|E2|Reported Event|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
335735|NCT00327444|E1|Reported Event|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
335736|NCT00327470|B3|Baseline|Total|Total of all reporting groups
335737|NCT00327470|B2|Baseline|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335738|NCT00327470|B1|Baseline|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335739|NCT00327470|P2|Participant Flow|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335740|NCT00327470|P1|Participant Flow|Early Age-related Macular Degeneration (AMD)|Subjects with early choroidal neovascularization (CNV) lesions were distinguished from subjects with established CNV lesions based on the stage of evolution of their CNV as determined by fluorescein angiography and, where available, indocyanine green angiography as assessed by the investigator at Baseline. Subjects with early CNV lesions were treated in the study eye with Macugen (0.3 milligram [mg]) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335741|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335742|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335743|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335744|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335745|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335746|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
337535|NCT00329238|B1|Baseline|Dabigatran|150 mg twice daily, total daily dose 300 mg
335747|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335748|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335749|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335750|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335751|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335752|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335753|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335754|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335755|NCT00327470|E2|Reported Event|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335756|NCT00327470|E1|Reported Event|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
335757|NCT00327717|B3|Baseline|Total|Total of all reporting groups
335758|NCT00327717|B2|Baseline|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335759|NCT00327717|B1|Baseline|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335760|NCT00327717|P2|Participant Flow|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335761|NCT00327717|P1|Participant Flow|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335762|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335763|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335764|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335765|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335766|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335841|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
335842|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
335767|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335768|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335769|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335770|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335771|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335772|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335773|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335774|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335775|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335776|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335777|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335778|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335779|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335780|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335781|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335782|NCT00327717|E2|Reported Event|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
335815|NCT00328094|O2|Outcome|Intermittent Insulin Bolus|Intermittent insulin boluses group
335816|NCT00328094|O1|Outcome|Continuous Insulin Infusion|Tight glucose group with insulin infusion
335783|NCT00327717|E1|Reported Event|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
335784|NCT00328016|B3|Baseline|Total|Total of all reporting groups
335785|NCT00328016|B2|Baseline|Control Group|The Control Group were instructed to sit in the same matter, passively attend to their breathing, and silently repeat 'one' during each exhalation. If thoughts came to mind, they were instructed to calmly refocus attention on breathing. Following two sessions of practice of passive attention to breathing, blood pressure and breathing parameters of each subject were also monitored during a 10 min baseline, 15 min passive attention to breathing and 10 min recovery period.
335786|NCT00328016|B1|Baseline|Device Guided Breathing|The Device Guided Breathing (DGB) group were instructed to sit comfortably with eyes closed and arms and legs uncrossed. Individual breathing rate was initially determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphone. Each subject was instructed to inspire during ascending tones and expire during descending tones, following two training sessions, respiration, blood pressure and breathing parameters were monitored during a 10 min rest period, a 15 min guided breathing task period, and a 10 min recovery period.
335787|NCT00328016|P2|Participant Flow|Control Group|The Control Group were instructed to sit in the same matter, passively attend to their breathing, and silently repeat 'one' during each exhalation. If thoughts came to mind, they were instructed to calmly refocus attention on breathing. Following two sessions of practice of passive attention to breathing, blood pressure and breathing parameters of each subject were also monitored during a 10 min baseline, 15 min passive attention to breathing and 10 min recovery period.
335843|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
335844|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
335788|NCT00328016|P1|Participant Flow|Device Guided Breathing|The Device Guided Breathing (DGB) group were instructed to sit comfortably with eyes closed and arms and legs uncrossed. Individual breathing rate was initially determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphone. Each subject was instructed to inspire during ascending tones and expire during descending tones, following two training sessions, respiration, blood pressure and breathing parameters were monitored during a 10 min rest period, a 15 min guided breathing task period, and a 10 min recovery period.
335789|NCT00328016|O2|Outcome|Control Group|Practiced passive attention to breathing
335790|NCT00328016|O1|Outcome|Device Guided Breathing|Practiced slow breathing using guided breathing device
335791|NCT00328016|O2|Outcome|Control Group|Practiced passive attention to breathing
335792|NCT00328016|O1|Outcome|Device Guided Breathing|Practiced slow breathing using guided breathing device
335793|NCT00328016|O2|Outcome|Control Group|Practiced passive attention to breathing
335794|NCT00328016|O1|Outcome|Device Guided Breathing|Practiced slow breathing using Guided Breathing Device
335795|NCT00328016|E2|Reported Event|Control Group|The Control Group were instructed to sit in the same matter, passively attend to their breathing, and silently repeat 'one' during each exhalation. If thoughts came to mind, they were instructed to calmly refocus attention on breathing. Following two sessions of practice of passive attention to breathing, blood pressure and breathing parameters of each subject were also monitored during a 10 min baseline, 15 min passive attention to breathing and 10 min recovery.
335796|NCT00328016|E1|Reported Event|Device Guided Breathing|The Device Guided Breathing (DGB) group were instructed to sit comfortably with eyes closed and arms and legs uncrossed. Individual breathing rate was initially determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphone. Each subject was instructed to inspire during ascending tones and expire during descending tones, following two training sessions, respiration, blood pressure and breathing parameters were monitored during a 10 min rest period, a 15 min guided breathing task period, and a 10 min recovery period during an experimental session on a subsequent day.
335797|NCT00328042|B3|Baseline|Total|Total of all reporting groups
335798|NCT00328042|B2|Baseline|Arm 2|Self-management self-study: This is an individual self-paced at home study program.
335799|NCT00328042|B1|Baseline|Arm 1|Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
335800|NCT00328042|P2|Participant Flow|Information Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
335801|NCT00328042|P1|Participant Flow|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
335802|NCT00328042|O2|Outcome|Information Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
335803|NCT00328042|O1|Outcome|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
335804|NCT00328042|O2|Outcome|Arm 2|Self-management self-study: This is an individual self-paced at home study program.
335805|NCT00328042|O1|Outcome|Arm 1|Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
335806|NCT00328042|E2|Reported Event|Information-Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
335807|NCT00328042|E1|Reported Event|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
335808|NCT00328094|B3|Baseline|Total|Total of all reporting groups
335809|NCT00328094|B2|Baseline|Intermittent Insulin Bolus|Intermittent insulin boluses group
335810|NCT00328094|B1|Baseline|Continuous Insulin Infusion|Tight glucose group with insulin infusion
335811|NCT00328094|P2|Participant Flow|Intermittent Insulin Bolus|Intermittent insulin boluses group
335812|NCT00328094|P1|Participant Flow|Continuous Insulin Infusion|Tight glucose group with insulin infusion
335813|NCT00328094|O2|Outcome|Intermittent Insulin Bolus|Intermittent insulin boluses group
335821|NCT00328172|B4|Baseline|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
335822|NCT00328172|B3|Baseline|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
335823|NCT00328172|B2|Baseline|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
335824|NCT00328172|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
335825|NCT00328172|P5|Participant Flow|Metformin|Patients randomized to receive treatment with metformin
335826|NCT00328172|P4|Participant Flow|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
335827|NCT00328172|P3|Participant Flow|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
335828|NCT00328172|P2|Participant Flow|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
335829|NCT00328172|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
335830|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
335831|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
335832|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
335833|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
335834|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
335835|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
335836|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
335847|NCT00328172|E3|Reported Event|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
335848|NCT00328172|E2|Reported Event|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
335849|NCT00328172|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
335850|NCT00328198|B1|Baseline|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
335851|NCT00328198|P1|Participant Flow|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
335852|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
335853|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
335854|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
335855|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
335856|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
335857|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
335858|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
335859|NCT00328198|E1|Reported Event|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
335860|NCT00328263|B3|Baseline|Total|Total of all reporting groups
335861|NCT00328263|B2|Baseline|Placebo|98g/day of placebo (devoid of microorganisms)
335862|NCT00328263|B1|Baseline|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
335863|NCT00328263|P2|Participant Flow|Placebo|98g/day of placebo (devoid of microorganisms)
335864|NCT00328263|P1|Participant Flow|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
335865|NCT00328263|O2|Outcome|Placebo|98g/day of placebo (devoid of microorganisms)
335866|NCT00328263|O1|Outcome|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
335867|NCT00328263|E2|Reported Event|Placebo|98g/day of placebo (devoid of microorganisms)
335868|NCT00328263|E1|Reported Event|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
335869|NCT00328510|B3|Baseline|Total|Total of all reporting groups
335870|NCT00328510|B2|Baseline|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
335871|NCT00328510|B1|Baseline|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
335872|NCT00328510|P2|Participant Flow|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
335873|NCT00328510|P1|Participant Flow|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
335874|NCT00328510|O2|Outcome|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
335875|NCT00328510|O1|Outcome|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
335876|NCT00328510|E2|Reported Event|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
335877|NCT00328510|E1|Reported Event|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
335878|NCT00328562|B1|Baseline|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:
Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
Level 3: 63.0 Gy in 15 fractions of 4.2 Gy
ZD1839 (Iressa)
Thoracic Radiotherapy"
335879|NCT00328562|P1|Participant Flow|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:
Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
Level 3: 63.0 Gy in 15 fractions of 4.2 Gy"
335880|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:
Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
Level 3: 63.0 Gy in 15 fractions of 4.2 Gy
ZD1839 (Iressa)
Thoracic Radiotherapy"
335881|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:
Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
Level 3: 63.0 Gy in 15 fractions of 4.2 Gy
ZD1839 (Iressa)
Thoracic Radiotherapy"
335882|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:
Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
Level 3: 63.0 Gy in 15 fractions of 4.2 Gy
ZD1839 (Iressa)
Thoracic Radiotherapy"
335883|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:
Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
Level 3: 63.0 Gy in 15 fractions of 4.2 Gy
ZD1839 (Iressa)
Thoracic Radiotherapy"
335884|NCT00328562|E1|Reported Event|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:
Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
Level 3: 63.0 Gy in 15 fractions of 4.2 Gy
ZD1839 (Iressa)
Thoracic Radiotherapy"
335885|NCT00328614|B7|Baseline|Total|Total of all reporting groups
335886|NCT00328614|B6|Baseline|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335887|NCT00328614|B5|Baseline|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335888|NCT00328614|B4|Baseline|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335889|NCT00328614|B3|Baseline|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335890|NCT00328614|B2|Baseline|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335891|NCT00328614|B1|Baseline|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335892|NCT00328614|P6|Participant Flow|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335893|NCT00328614|P5|Participant Flow|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335894|NCT00328614|P4|Participant Flow|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335895|NCT00328614|P3|Participant Flow|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335896|NCT00328614|P2|Participant Flow|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335897|NCT00328614|P1|Participant Flow|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335898|NCT00328614|O1|Outcome|Samarium-153|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335899|NCT00328614|E6|Reported Event|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335900|NCT00328614|E5|Reported Event|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335901|NCT00328614|E4|Reported Event|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335902|NCT00328614|E3|Reported Event|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335903|NCT00328614|E2|Reported Event|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335904|NCT00328614|E1|Reported Event|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
335905|NCT00328627|B13|Baseline|Total|Total of all reporting groups
335906|NCT00328627|B12|Baseline|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335907|NCT00328627|B11|Baseline|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335908|NCT00328627|B10|Baseline|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335909|NCT00328627|B9|Baseline|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335910|NCT00328627|B8|Baseline|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335911|NCT00328627|B7|Baseline|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335912|NCT00328627|B6|Baseline|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335913|NCT00328627|B5|Baseline|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335914|NCT00328627|B4|Baseline|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335915|NCT00328627|B3|Baseline|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335916|NCT00328627|B2|Baseline|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335917|NCT00328627|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335918|NCT00328627|P12|Participant Flow|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335919|NCT00328627|P11|Participant Flow|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335920|NCT00328627|P10|Participant Flow|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335921|NCT00328627|P9|Participant Flow|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335922|NCT00328627|P8|Participant Flow|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335923|NCT00328627|P7|Participant Flow|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335924|NCT00328627|P6|Participant Flow|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335925|NCT00328627|P5|Participant Flow|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335926|NCT00328627|P4|Participant Flow|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335927|NCT00328627|P3|Participant Flow|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335928|NCT00328627|P2|Participant Flow|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335929|NCT00328627|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335930|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335931|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335932|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335933|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335934|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335935|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335936|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335937|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335938|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335939|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335940|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335941|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335942|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335943|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335944|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335945|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335946|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335947|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335948|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335949|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335950|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335951|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335952|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335953|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335954|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
335955|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
335956|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
335957|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335958|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335959|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335960|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335961|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335962|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335963|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335964|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335965|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335966|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335967|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335968|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335969|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335970|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335971|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335972|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335973|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335974|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335975|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335976|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335977|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335978|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335979|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336519|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
335980|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335981|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
335982|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
335983|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
335984|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335985|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335986|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335987|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335988|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335989|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
335990|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335991|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335992|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
335993|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335994|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335995|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
335996|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335997|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335998|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
335999|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336000|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336001|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336002|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336003|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336004|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336005|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336006|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336007|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336008|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336009|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336010|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336011|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336012|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336013|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336014|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336015|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336016|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336017|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336018|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
338560|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
336019|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336020|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336021|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336022|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336023|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336024|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336025|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336026|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336027|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336028|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336029|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336030|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336031|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336032|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336033|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336034|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336035|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336036|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336037|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336038|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336039|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336040|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336041|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336042|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336043|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336044|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336045|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336046|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336047|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336048|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336049|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336050|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336051|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336052|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336053|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336054|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336055|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336056|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336520|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336057|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336058|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336059|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336060|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336061|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336062|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336063|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336064|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336065|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336066|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336067|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336068|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336069|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336070|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336071|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336072|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336073|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337536|NCT00329238|P2|Participant Flow|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
336074|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336075|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336076|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336077|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336078|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336079|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336080|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336081|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336082|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336083|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336084|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336085|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336086|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336087|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336088|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336089|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336090|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336091|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336092|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336093|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336094|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336095|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
338561|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
336096|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336097|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336098|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336099|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336100|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336101|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336102|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336103|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336104|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336105|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336106|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336107|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336108|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336109|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336110|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336111|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336112|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336113|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336114|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336115|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336116|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336117|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336118|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336119|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336120|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336121|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336122|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336123|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336124|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336125|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336126|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336127|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336128|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336129|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336130|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336131|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336132|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336133|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
338562|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
336134|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336135|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336136|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336137|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336138|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336139|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336140|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336141|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336142|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336143|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336144|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336145|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336146|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336147|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336148|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336149|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336150|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336151|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336152|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336153|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336154|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336155|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336156|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336157|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336158|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336159|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336160|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336161|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336162|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336163|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336164|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336165|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336166|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336167|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336168|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336169|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336170|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336171|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336172|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
338563|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
336173|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336174|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336175|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336176|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336177|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336178|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336179|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336180|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336181|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336182|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336183|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336184|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336185|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336186|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336187|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336188|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336189|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336190|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336191|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336192|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336193|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336194|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336195|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336196|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336197|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336198|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336199|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336200|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336201|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336202|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336203|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336204|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336205|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336206|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336207|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336208|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336209|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336210|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
338564|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
336211|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336212|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336213|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336214|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336215|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336216|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336217|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336218|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336219|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336220|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336221|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336222|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336223|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336224|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336225|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336226|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336227|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336228|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336229|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336230|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336231|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336232|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336233|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336234|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336235|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336236|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336237|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336238|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336239|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336240|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336241|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336242|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336243|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336244|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336245|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336246|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336247|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336248|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
338565|NCT00311376|E3|Reported Event|Placebo|Normal saline (placebo)
336249|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336250|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336251|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336252|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336253|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336254|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336255|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336256|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336257|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336258|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336259|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336260|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336261|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336262|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336263|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336264|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336265|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336266|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336267|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336268|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336269|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336270|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336271|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336272|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336273|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336274|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336275|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336276|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336277|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336278|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336279|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336280|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336281|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336282|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336283|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336284|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336285|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336286|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336287|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
338566|NCT00311376|E2|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
336288|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336289|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336290|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336291|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336292|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336293|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336294|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336295|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336296|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336297|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336298|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336299|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336300|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336301|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336302|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336303|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336304|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336305|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336306|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336307|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336308|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336309|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336310|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336311|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336312|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336313|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336314|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336315|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336316|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336317|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336318|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336319|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336320|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336321|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336322|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336323|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336324|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336325|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
338567|NCT00311376|E1|Reported Event|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
336326|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336327|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336328|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336329|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336330|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336331|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336332|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336333|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336334|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336335|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336336|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336337|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336338|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336339|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336340|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336341|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336342|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336343|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336344|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336345|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336346|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336347|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336348|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336349|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336350|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336351|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336352|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336353|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336354|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336355|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336356|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336357|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336358|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336359|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336360|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336361|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336362|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336363|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336364|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
338568|NCT00311402|B3|Baseline|Total|Total of all reporting groups
336365|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336366|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336367|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336368|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336369|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336370|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336371|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336372|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336373|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336374|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336375|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336376|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336377|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336378|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336379|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336380|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336381|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336382|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336383|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336384|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336385|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336386|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336387|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336388|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336389|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336390|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336391|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336392|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336393|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336394|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336395|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336396|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336397|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336398|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336399|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336400|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336401|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336402|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336403|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336404|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336405|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336406|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336407|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336408|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336409|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336410|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336411|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336412|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336413|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336414|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336415|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336416|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336417|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336418|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337537|NCT00329238|P1|Participant Flow|Dabigatran|150 mg twice daily, total daily dose 300 mg
336419|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336420|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336421|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336422|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336423|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336424|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336425|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336426|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336427|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336428|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336429|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336430|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336431|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336432|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336433|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336434|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336435|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336436|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336437|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336438|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336439|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336440|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336441|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
338569|NCT00311402|B2|Baseline|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
336442|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336443|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336444|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336445|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336446|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336447|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336448|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336449|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336450|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336451|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336452|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336453|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336454|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336455|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336456|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336457|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336458|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336459|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336460|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336461|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336462|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336463|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336464|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336465|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336466|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336467|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336468|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336469|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336470|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336471|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336472|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336473|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336474|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336475|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336476|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336477|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336478|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336479|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
338571|NCT00311402|P2|Participant Flow|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
336480|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336481|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336482|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336483|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336484|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336485|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336486|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336487|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336488|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336489|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336490|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336491|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336492|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336493|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336494|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336495|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336496|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336497|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336498|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336499|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336500|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336501|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336502|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336503|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336504|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336505|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336506|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336507|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336508|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336509|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336510|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336511|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336512|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336513|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336514|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336515|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336516|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336517|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336518|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336521|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336522|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336523|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336524|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336525|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336526|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336527|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336528|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336529|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336530|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336531|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336532|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336533|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336534|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336535|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336536|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336537|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336538|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336539|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336540|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336541|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336542|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336543|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336544|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336545|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336546|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336547|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336548|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336549|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336550|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336551|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336552|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336553|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336554|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336555|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336556|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336557|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336558|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336559|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336560|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336561|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336562|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336563|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336564|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336565|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336566|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336567|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336568|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336569|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336570|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336571|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336572|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336573|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336574|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336575|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336576|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336577|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336578|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336579|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336580|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336581|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336582|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336583|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336584|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336585|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336586|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336587|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336588|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336589|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336590|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336591|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336592|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336593|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336594|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336595|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336596|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
339105|NCT00314951|E1|Reported Event|Vancomycin|125 mg administered 4 times daily (q6hr)
336597|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336598|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336599|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336600|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336601|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336602|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336603|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336604|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336605|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336606|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336607|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336608|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336609|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336610|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336611|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336612|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336613|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336614|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336615|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336616|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336617|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336618|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336619|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336620|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336621|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336622|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336623|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336624|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336625|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336626|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336627|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336628|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336629|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336630|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336631|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336632|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336633|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336634|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336635|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336636|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336637|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336638|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336639|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336640|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336641|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336642|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336643|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336644|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336645|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336646|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336647|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336648|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336649|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336650|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336651|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336652|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336653|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336654|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336655|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336656|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336657|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336658|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336659|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336660|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336661|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336662|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336663|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336664|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336665|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336666|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336667|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336668|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336669|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336670|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336671|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336672|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
339106|NCT00315055|B3|Baseline|Total|Total of all reporting groups
336673|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336674|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336675|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336676|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336677|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336678|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336679|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336680|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336681|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336682|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336683|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336684|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336685|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336686|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336687|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336688|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336689|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336690|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336691|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336692|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336693|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336694|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336695|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336696|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336697|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336698|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336699|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336700|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336701|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336702|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336703|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336704|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336705|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336706|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336707|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336708|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336709|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336710|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336711|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336712|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336713|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336714|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336715|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336716|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336717|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336718|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336719|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336720|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336721|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336722|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336723|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336724|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336725|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336726|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336727|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336728|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336729|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336730|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336731|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336732|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336733|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336734|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336735|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336736|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336737|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336738|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336739|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336740|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336741|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336742|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336743|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336744|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336745|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336746|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336747|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336748|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
339134|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
336749|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336750|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336751|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336752|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336753|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336754|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336755|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336756|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336757|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336758|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336759|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336760|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336761|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336762|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336763|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336764|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336765|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336766|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336767|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336768|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336769|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336770|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336771|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336772|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336773|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336774|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336775|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336776|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336777|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336778|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336779|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336780|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336781|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336782|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336783|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336784|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336785|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336786|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336787|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336788|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336789|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336790|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336791|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336792|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336793|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336794|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336795|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336796|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336797|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336798|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336799|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336800|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336801|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336802|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336803|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336804|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336805|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336806|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336807|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336808|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336809|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336810|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336811|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336812|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336813|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336814|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336815|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336816|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336817|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336818|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336819|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336820|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336821|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336822|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336823|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336824|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
339135|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
336825|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336826|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336827|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336828|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336829|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336830|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336831|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336832|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336833|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336834|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336835|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336836|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336837|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336838|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336839|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336840|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336841|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336842|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336843|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336844|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336845|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336846|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336847|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336848|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336849|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336850|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336851|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336852|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336853|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336854|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336855|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336856|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336857|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336858|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336859|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336860|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336861|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336862|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336863|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336864|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336865|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336866|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336867|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336868|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336869|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336870|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336871|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336872|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336873|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336874|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336875|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336876|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336877|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336878|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336879|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336880|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336881|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336882|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336883|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336884|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336885|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336886|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336887|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336888|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336889|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336890|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336891|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336892|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336893|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336894|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336895|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336896|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336897|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336898|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336899|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336900|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
339136|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
336901|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336902|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336903|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336904|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336905|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336906|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336907|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336908|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336909|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336910|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336911|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336912|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336913|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336914|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336915|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336916|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336917|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336918|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336919|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336920|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336921|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336922|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336923|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336924|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336925|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336926|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336927|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336928|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336929|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336930|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336931|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336932|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336933|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336934|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336935|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336936|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336937|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336938|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336939|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336940|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336941|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336942|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336943|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336944|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336945|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336946|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336947|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336948|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336949|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336950|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336951|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336952|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336953|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336954|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336955|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336956|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336957|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336958|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336959|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336960|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336961|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336962|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336963|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336964|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336965|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336966|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336967|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336968|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
336969|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
336970|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
336971|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336972|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336973|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336974|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336975|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336976|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
339137|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
336977|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336978|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336979|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336980|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336981|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336982|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336983|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336984|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336985|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336986|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336987|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336988|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336989|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336990|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336991|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
336992|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336993|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336994|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
336995|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336996|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336997|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
336998|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
336999|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337000|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337001|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337002|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337003|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337004|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337005|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337006|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337007|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337008|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337009|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337010|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337011|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337012|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337013|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337014|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337015|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337016|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337017|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337018|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337019|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337020|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337021|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337022|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337023|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337024|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337025|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337026|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337027|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337028|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337029|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337030|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337031|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337032|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337033|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337034|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337035|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337036|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337037|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337038|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337039|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337040|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337041|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337042|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337043|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337044|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337045|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337046|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337047|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337048|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337049|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337050|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337051|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337052|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
339138|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
337053|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337054|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337055|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337056|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337057|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337058|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337059|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337060|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337061|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337062|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337063|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337064|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337065|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337066|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337067|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337068|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337069|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337070|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337071|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337072|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337073|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337074|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337075|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337076|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337077|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337078|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337079|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337080|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337081|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337082|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337083|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337084|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337085|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337086|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337087|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337088|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337089|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337090|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337091|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337092|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337093|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337094|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337095|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337096|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337097|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337098|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337099|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337100|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337101|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337102|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337103|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337104|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337105|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337106|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337107|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337108|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337109|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337110|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337111|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337112|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337113|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337114|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337115|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337116|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337117|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337118|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337119|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337120|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337121|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337122|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337123|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337124|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337125|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337126|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337127|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337128|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
339139|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
337129|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337130|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337131|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337132|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337133|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337134|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337135|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337136|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337137|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337138|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337139|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337140|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337141|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337142|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337143|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337144|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337145|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337146|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337147|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337148|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337149|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337150|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337151|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337152|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337153|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337154|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337155|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337156|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337157|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337158|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337159|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337160|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337161|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337162|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337163|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337164|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337165|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337166|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337167|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
339140|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
337168|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337169|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337170|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337171|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337172|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337173|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337174|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337175|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337176|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337177|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337178|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337179|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337180|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337181|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337182|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337183|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337184|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337185|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337186|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337187|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337188|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337189|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337190|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337191|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337192|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337193|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337194|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337195|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337196|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337197|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337198|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337199|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337200|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337201|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337202|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337203|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337204|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337205|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337206|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337207|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
339141|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
337208|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337209|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337210|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337211|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337212|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337213|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337214|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337215|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337216|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337217|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337218|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337219|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337220|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337221|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337222|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337223|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337224|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337225|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337226|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337227|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337228|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337229|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337230|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337231|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337232|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337233|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337234|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337235|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337236|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337237|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337238|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337239|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337240|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337241|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337242|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337243|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337244|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337245|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337246|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
339142|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
337247|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337248|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337249|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337250|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337251|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337252|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337253|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337254|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337255|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337256|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337257|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337258|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337259|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337260|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337261|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337262|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337263|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337264|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337265|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337266|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337267|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337268|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337269|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337270|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337271|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337272|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337273|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337274|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337275|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337276|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337277|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337278|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337279|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337280|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337281|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337282|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337283|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337284|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337285|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
339143|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
337286|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337287|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337288|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337289|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337290|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337291|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337292|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337293|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337294|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337295|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337296|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337297|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337298|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337299|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337300|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337301|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337302|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337303|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337304|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337305|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337306|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337307|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337308|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337309|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337310|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337311|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337312|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337313|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337314|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337315|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337316|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337317|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337318|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337319|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337320|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337321|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337322|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337323|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337324|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337325|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337326|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337327|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337328|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337329|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337330|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337331|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337332|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337333|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337334|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337335|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337336|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337337|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337338|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337339|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337340|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337341|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337342|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337343|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337344|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337345|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337346|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337347|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337348|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337349|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337350|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337351|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337352|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337353|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337354|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337355|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337356|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337357|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337358|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337359|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337360|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337361|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337362|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337363|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337364|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337365|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337366|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337367|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337368|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337369|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337370|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337371|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337372|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337373|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337374|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337375|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337376|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337538|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337377|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337378|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337379|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337380|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337381|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337382|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337383|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337384|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337385|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337386|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337387|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337388|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337389|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337390|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337391|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337392|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337393|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337394|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337395|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337396|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337397|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337398|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337399|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
339144|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
337400|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337401|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337402|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337403|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337404|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337405|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337406|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337407|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337408|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337409|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337410|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337411|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337412|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337413|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337414|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337415|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337416|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337417|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337418|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337419|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337420|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337421|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337422|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337423|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337424|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337425|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337426|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337427|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
337428|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
337429|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
337430|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|"Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
This combination group includes participants from the following three treatment arms:
Alogliptin 25 mg + Pioglitazone 15 mg
Alogliptin 25 mg + Pioglitazone 30 mg
Alogliptin 25 mg + Pioglitazone 45 mg"
337431|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|"Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
This combination group includes participants from the following three treatment arms:
Alogliptin 12.5 mg + Pioglitazone 15 mg
Alogliptin 12.5 mg + Pioglitazone 30 mg
Alogliptin 12.5 mg + Pioglitazone 45 mg"
337432|NCT00328627|O1|Outcome|Pioglitazone Alone|"Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
This combination group includes participants from the following three treatment arms:
Placebo + Pioglitazone 15 mg
Placebo + Pioglitazone 30 mg
Placebo + Pioglitazone 45 mg"
337433|NCT00328627|E12|Reported Event|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337434|NCT00328627|E11|Reported Event|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
337435|NCT00328627|E10|Reported Event|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
339145|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
337436|NCT00328627|E9|Reported Event|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337437|NCT00328627|E8|Reported Event|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337438|NCT00328627|E7|Reported Event|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
337439|NCT00328627|E6|Reported Event|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337440|NCT00328627|E5|Reported Event|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337441|NCT00328627|E4|Reported Event|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
337442|NCT00328627|E3|Reported Event|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337443|NCT00328627|E2|Reported Event|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337444|NCT00328627|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
337445|NCT00328770|B1|Baseline|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
337446|NCT00328770|P1|Participant Flow|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
337447|NCT00328770|O1|Outcome|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
337448|NCT00328770|O1|Outcome|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
337449|NCT00328770|O1|Outcome|Patient Survival|1 and 4 year patient survival
337450|NCT00328770|E1|Reported Event|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
337451|NCT00328783|B1|Baseline|Active Breathing Coordinator|"Patients breathe through the ABC device
Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
337452|NCT00328783|P1|Participant Flow|Active Breathing Coordinator|"Patients breathe through the ABC device
Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
337453|NCT00328783|O1|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device
Active Breathing Coordinator (ABC): The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
337454|NCT00328783|O1|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device
Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
337455|NCT00328783|E1|Reported Event|Active Breathing Coordinator|"Patients breathe through the ABC device
Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
337456|NCT00328861|B3|Baseline|Total|Total of all reporting groups
337457|NCT00328861|B2|Baseline|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
337458|NCT00328861|B1|Baseline|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
337459|NCT00328861|P2|Participant Flow|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
337460|NCT00328861|P1|Participant Flow|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
337461|NCT00328861|O2|Outcome|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
337462|NCT00328861|O1|Outcome|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
337463|NCT00328861|O2|Outcome|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
337579|NCT00329420|B2|Baseline|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337464|NCT00328861|O1|Outcome|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
337465|NCT00328861|E2|Reported Event|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
337466|NCT00328861|E1|Reported Event|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
337467|NCT00328926|B4|Baseline|Total|Total of all reporting groups
337468|NCT00328926|B3|Baseline|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337469|NCT00328926|B2|Baseline|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337470|NCT00328926|B1|Baseline|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337471|NCT00328926|P3|Participant Flow|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337472|NCT00328926|P2|Participant Flow|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337473|NCT00328926|P1|Participant Flow|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337474|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337527|NCT00329160|P1|Participant Flow|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
338386|NCT00329901|P3|Participant Flow|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
337475|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337476|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337477|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337539|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337540|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337541|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337478|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337479|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337480|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337481|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337482|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337483|NCT00328926|E3|Reported Event|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
339146|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
337484|NCT00328926|E2|Reported Event|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337485|NCT00328926|E1|Reported Event|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
337486|NCT00329030|B3|Baseline|Total|Total of all reporting groups
337487|NCT00329030|B2|Baseline|R-BEAM|Rituxan/BEAM
337488|NCT00329030|B1|Baseline|B-BEAM|Bexxar/BEAM
337489|NCT00329030|P2|Participant Flow|R-BEAM|Patients received Rituxan/BEAM, with Rituxan 375 mg/m2 IV Days -19 and -12, BCNU 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
337542|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337543|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337490|NCT00329030|P1|Participant Flow|B-BEAM|Patients received Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive carmustine (BCNU) 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
337491|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337492|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337493|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337494|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337495|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337496|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337497|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337498|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337499|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337500|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337501|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337502|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337503|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337504|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337505|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337506|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337507|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337508|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337509|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337510|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337511|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337512|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337513|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
337514|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
337515|NCT00329030|E2|Reported Event|R-BEAM|Rituxan/BEAM
337516|NCT00329030|E1|Reported Event|B-BEAM|Bexxar/BEAM
337517|NCT00329108|B3|Baseline|Total|Total of all reporting groups
337518|NCT00329108|B2|Baseline|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
337519|NCT00329108|B1|Baseline|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
337520|NCT00329108|P2|Participant Flow|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
337521|NCT00329108|P1|Participant Flow|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
337522|NCT00329108|O2|Outcome|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
337523|NCT00329108|O1|Outcome|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
337524|NCT00329108|E2|Reported Event|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
337525|NCT00329108|E1|Reported Event|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
337526|NCT00329160|B1|Baseline|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
338387|NCT00329901|P2|Participant Flow|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
337528|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
337529|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
337530|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
337531|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
337532|NCT00329160|E1|Reported Event|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
337533|NCT00329238|B3|Baseline|Total|Total of all reporting groups
337534|NCT00329238|B2|Baseline|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337547|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337548|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337549|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337550|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337551|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337552|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337553|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337554|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337555|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337556|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337557|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337558|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337559|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337560|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337561|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337562|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337563|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337564|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337565|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337566|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337567|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
337568|NCT00329238|E4|Reported Event|Post Warfarin|
337569|NCT00329238|E3|Reported Event|Post Dabigatran|
337570|NCT00329238|E2|Reported Event|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
337571|NCT00329238|E1|Reported Event|Dabigatran|150 mg twice daily, total daily dose 300 mg
337572|NCT00329407|B1|Baseline|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
337573|NCT00329407|P1|Participant Flow|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
337574|NCT00329407|O1|Outcome|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
337575|NCT00329407|O1|Outcome|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
337576|NCT00329407|E1|Reported Event|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
337577|NCT00329420|B4|Baseline|Total|Total of all reporting groups
337578|NCT00329420|B3|Baseline|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337580|NCT00329420|B1|Baseline|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337581|NCT00329420|P3|Participant Flow|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337582|NCT00329420|P2|Participant Flow|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337583|NCT00329420|P1|Participant Flow|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337584|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337585|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337586|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337587|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337588|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337589|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337590|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337591|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337592|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338241|NCT00329602|O2|Outcome|Double-blind Placebo|Matching placebo tablets
338242|NCT00329602|O1|Outcome|Overall Study|
337593|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337594|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337595|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337596|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337597|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337598|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337599|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337600|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337601|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337602|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337603|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337604|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337605|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337606|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337607|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338003|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337608|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337609|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337610|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337611|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337612|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337613|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337614|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337615|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337616|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337617|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337618|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337619|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337620|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337621|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337622|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337623|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337624|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337625|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337626|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337627|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337628|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337629|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337630|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337631|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337632|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337633|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337634|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337635|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338006|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337636|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337637|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337638|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337639|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337640|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337641|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337642|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337643|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337644|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337645|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337646|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337647|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337648|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337649|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337650|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337651|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337652|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337653|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337654|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337655|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337656|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337657|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337658|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337659|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337660|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337661|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337662|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337663|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337664|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337665|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337666|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337667|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337668|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337669|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337670|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337671|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337672|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337673|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337674|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337675|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337676|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337677|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337678|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337679|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337680|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337681|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337682|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337683|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337684|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337685|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337686|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337687|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337688|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337689|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337690|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337691|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337692|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338069|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337693|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337694|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337695|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337696|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337697|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337698|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337699|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337700|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337701|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337702|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337703|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337704|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337705|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337706|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337707|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337708|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337709|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337710|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337711|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337712|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337713|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337714|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337715|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337716|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337717|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337718|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337719|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337720|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337721|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337722|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337723|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337724|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337725|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337726|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337727|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337728|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337729|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337730|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337731|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337732|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337733|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337734|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337735|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337736|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337737|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337738|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337739|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337740|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337741|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337742|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337743|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337744|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337745|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337746|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337747|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337748|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337749|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338132|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337750|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337751|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337752|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337753|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337754|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337755|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337756|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337757|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337758|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337759|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337760|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337761|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337762|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337763|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337764|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337765|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337766|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337767|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337768|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337769|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337770|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337771|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337772|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337773|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337774|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337775|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337776|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337777|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337778|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337779|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337780|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337781|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337782|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337783|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337784|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337785|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337786|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337787|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337788|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337789|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337790|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337791|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337792|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337793|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337794|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337795|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337796|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337797|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337798|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337799|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337800|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337801|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337802|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337803|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337804|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337805|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337806|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338195|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337807|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337808|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337809|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337810|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337811|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337812|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337813|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337814|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337815|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337816|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337817|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337818|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337819|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337820|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337821|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337822|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337823|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337824|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337825|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337826|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337827|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337828|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337829|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337830|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337831|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337832|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337833|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337834|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337835|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337836|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337837|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337838|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337839|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337840|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337841|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337842|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337843|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337844|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337845|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337846|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337847|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337848|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337849|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337850|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337851|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337852|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337853|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337854|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337855|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337856|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337857|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337858|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337859|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337860|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337861|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337862|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337863|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338322|NCT00329771|B1|Baseline|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
339147|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
337864|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337865|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337866|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337867|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337868|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337869|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337870|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337871|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337872|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337873|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337874|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337875|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337876|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337877|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337878|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337879|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337880|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337881|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337882|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337883|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337884|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337885|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337886|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337887|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337888|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337889|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337890|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337891|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337892|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337893|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337894|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337895|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337896|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337897|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337898|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337899|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337900|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337901|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337902|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337903|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337904|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337905|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337906|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337907|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337908|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337909|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337910|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337911|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337912|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337913|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337914|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337915|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337916|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337917|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337918|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337919|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337920|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338323|NCT00329771|P1|Participant Flow|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
339148|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
337921|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337922|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337923|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337924|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337925|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337926|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337927|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337928|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337929|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337930|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337931|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337932|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337933|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337934|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337935|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337936|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337937|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337938|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337939|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337940|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337941|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337942|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337943|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337944|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337945|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337946|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337947|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337948|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337949|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337950|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337951|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337952|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337953|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337954|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337955|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337956|NCT00329420|E5|Reported Event|Total 2 (Treatment With CZP in Main Study and Extension Study)|This includes all adverse event data from the 6-week double-blind main study (N00291668) and this extension study for all 46 subjects who entered this extension study C87048, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.
337957|NCT00329420|E4|Reported Event|Total 1 (This Extension Study Only)|This includes all adverse event data collected in this extension study for all 46 subjects who entered this extension study.
337958|NCT00329420|E3|Reported Event|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337959|NCT00329420|E2|Reported Event|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337960|NCT00329420|E1|Reported Event|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337961|NCT00329433|B3|Baseline|Total|Total of all reporting groups
337962|NCT00329433|B2|Baseline|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
337963|NCT00329433|B1|Baseline|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
337964|NCT00329433|P2|Participant Flow|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
337965|NCT00329433|P1|Participant Flow|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
337966|NCT00329433|O2|Outcome|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
337967|NCT00329433|O1|Outcome|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
337968|NCT00329433|E2|Reported Event|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
337969|NCT00329433|E1|Reported Event|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
337970|NCT00329524|B1|Baseline|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
337971|NCT00329524|P1|Participant Flow|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
337972|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
337973|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
337974|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
338004|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338005|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337975|NCT00329524|E1|Reported Event|Active Versus Sham Treatment|"Subjects randomly assigned to active and sham TMS separated by one week interval.
Repetitive Transcranial Magnetic Stimulation (rTMS): TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectiv"
337976|NCT00329550|B4|Baseline|Total|Total of all reporting groups
337977|NCT00329550|B3|Baseline|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337978|NCT00329550|B2|Baseline|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337979|NCT00329550|B1|Baseline|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337980|NCT00329550|P3|Participant Flow|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337981|NCT00329550|P2|Participant Flow|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337982|NCT00329550|P1|Participant Flow|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337983|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337984|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337985|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338798|NCT00313703|O1|Outcome|Migraine|met International Headache Society migraine criteria
337986|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337987|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337988|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337989|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337990|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337991|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337992|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337993|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337994|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337995|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337996|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337997|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337998|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
337999|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338000|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338001|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338002|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338324|NCT00329771|O1|Outcome|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
338007|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338008|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338009|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338010|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338011|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338012|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338013|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338014|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338015|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338016|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338017|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338018|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338019|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338020|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338021|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338022|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338023|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338024|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338025|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338026|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338027|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338028|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338029|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338030|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338031|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338032|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338033|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338034|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338035|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338036|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338037|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338325|NCT00329771|E1|Reported Event|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
338038|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338039|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338040|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338041|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338042|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338043|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338044|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338045|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338046|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338047|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338048|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338049|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338050|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338051|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338052|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338053|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338054|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338055|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338056|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338057|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338058|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338059|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338060|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338061|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338062|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338063|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338064|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338065|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338066|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338067|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338068|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338326|NCT00329784|B5|Baseline|Total|Total of all reporting groups
338070|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338071|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338072|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338073|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338074|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338075|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338076|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338077|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338078|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338079|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338080|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338081|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338082|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338083|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338084|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338085|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338086|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338087|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338088|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338089|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338090|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338091|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338092|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338093|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338094|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338095|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338096|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338097|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338098|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338099|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338100|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
339149|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
338101|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338102|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338103|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338104|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338105|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338106|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338107|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338108|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338109|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338110|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338111|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338112|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338113|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338114|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338115|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338116|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338117|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338118|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338119|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338120|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338121|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338122|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338123|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338124|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338125|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338126|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338127|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338128|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338129|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338130|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338131|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
339150|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
338133|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338134|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338135|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338136|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338137|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338138|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338139|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338140|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338141|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338142|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338143|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338144|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338145|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338146|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338147|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338148|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338149|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338150|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338151|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338152|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338153|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338154|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338155|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338156|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338157|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338158|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338159|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338160|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338161|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338162|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338163|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
339151|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
338164|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338165|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338166|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338167|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338168|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338169|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338170|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338171|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338172|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338173|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338174|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338175|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338176|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338177|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338178|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338179|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338180|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338181|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338182|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338183|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338184|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338185|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338186|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338187|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338188|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338189|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338190|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338191|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338192|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338193|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338194|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
339152|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
338196|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338197|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338198|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338199|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338200|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338201|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338202|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338203|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338204|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338205|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338206|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338207|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338208|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338209|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338210|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338211|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338212|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338213|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338214|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338215|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338216|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338217|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338218|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338219|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338220|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338221|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338222|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338223|NCT00329550|E5|Reported Event|Total 2 (Treatment With CZP in Main Study and Extension Study)|This includes all adverse event data from the 6-week double-blind main study (NCT00291668) and this extension study for all 40 subjects who entered this extension study, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.
338224|NCT00329550|E4|Reported Event|Total 1 (This Extension Study Only)|This includes all adverse event data collected in this extension study for all 40 subjects who entered this extension study.
338225|NCT00329550|E3|Reported Event|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
339153|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
338226|NCT00329550|E2|Reported Event|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338227|NCT00329550|E1|Reported Event|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
338228|NCT00329602|B3|Baseline|Total|Total of all reporting groups
338229|NCT00329602|B2|Baseline|Double-Blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338230|NCT00329602|B1|Baseline|Double-Blind Placebo|Matching placebo tablets
338231|NCT00329602|P3|Participant Flow|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338232|NCT00329602|P2|Participant Flow|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338233|NCT00329602|P1|Participant Flow|Double-blind Placebo|Matching placebo tablets
338234|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Double-Blind Ropinirole participants (receiving Ropinirole IR [immediate release] tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day) who were not excluded from the IRLS post-hoc analysis
338235|NCT00329602|O1|Outcome|Double-blind Placebo|Double-Blind Placebo participants (receiving matching placebo tablets) who were not excluded from the IRLS post-hoc analysis
338236|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Double-Blind Ropinirole participants (receiving Ropinirole IR [immediate release] tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day) who were not in the center groups with the highest or lowest treatment effects
338237|NCT00329602|O1|Outcome|Double-blind Placebo|Double-Blind Placebo participants (receiving matching placebo tablets) who were not in the center groups with the highest or lowest treatment effects
338238|NCT00329602|O1|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338239|NCT00329602|O4|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338240|NCT00329602|O3|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338243|NCT00329602|O1|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338244|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338245|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
338246|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338247|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
338248|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338249|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
338250|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338251|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
338252|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338253|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
338254|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338255|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
338256|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338257|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
338258|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338259|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
338260|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338261|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
338262|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338263|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
338264|NCT00329602|E3|Reported Event|Open-Label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
339154|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
338265|NCT00329602|E2|Reported Event|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
338266|NCT00329602|E1|Reported Event|Double-blind Placebo|Matching placebo tablets
338267|NCT00329641|B1|Baseline|Sorafenib, Carboplatin, Paclitaxel|
338268|NCT00329641|P1|Participant Flow|Sorafenib, Carboplatin, Paclitaxel|Standard carboplatin and paclitaxel doses with the addition of sorafenib (800 mg daily)
338269|NCT00329641|O1|Outcome|Intervention|Sorafenib, Carboplatin, Paclitaxel
338270|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
338271|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
338272|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
338273|NCT00329641|E1|Reported Event|Intervention|Sorafenib, Carboplatin, Paclitaxel
338274|NCT00329719|B5|Baseline|Total|Total of all reporting groups
338275|NCT00329719|B4|Baseline|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)
Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338276|NCT00329719|B3|Baseline|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)
Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV
conventional surgery: Undergo surgery"
338277|NCT00329719|B2|Baseline|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)
Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338278|NCT00329719|B1|Baseline|Phase I, Arm A|"Phase I, Arm A, Dose Escalation
Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338279|NCT00329719|P4|Participant Flow|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)
Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338297|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)
Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338408|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
338280|NCT00329719|P3|Participant Flow|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)
Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV
conventional surgery: Undergo surgery"
338281|NCT00329719|P2|Participant Flow|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)
Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338282|NCT00329719|P1|Participant Flow|Phase I, Arm A|"Phase I, Arm A, Dose Escalation
Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338283|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)
Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338284|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)
Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV
conventional surgery: Undergo surgery"
338285|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)
Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338286|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation
Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338287|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)
Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338288|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)
Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV
conventional surgery: Undergo surgery"
338289|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)
Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338327|NCT00329784|B4|Baseline|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338290|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation
Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338291|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)
Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338292|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)
Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV
conventional surgery: Undergo surgery"
338293|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)
Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338294|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation
Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338295|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)
Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338296|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)
Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV
conventional surgery: Undergo surgery"
338298|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation
Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338299|NCT00329719|E4|Reported Event|Phase II, Arm D|"Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338300|NCT00329719|E3|Reported Event|Phase II, Arm C|"Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV
conventional surgery: Undergo surgery"
338301|NCT00329719|E2|Reported Event|Phase II, Arm B|"Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338302|NCT00329719|E1|Reported Event|Phase I, Arm A|"Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
sorafenib tosylate: Given PO
temsirolimus: Given IV"
338303|NCT00329732|B3|Baseline|Total|Total of all reporting groups
338304|NCT00329732|B2|Baseline|Saline (Placebo)|
338305|NCT00329732|B1|Baseline|Lidocaine/Bupivicaine|
338306|NCT00329732|P2|Participant Flow|Saline (Placebo)|
338307|NCT00329732|P1|Participant Flow|Lidocaine/Bupivicaine|
338308|NCT00329732|O1|Outcome|Lidocaine/Bupivicaine|
338309|NCT00329732|E2|Reported Event|Saline (Placebo)|
338310|NCT00329732|E1|Reported Event|Lidocaine/Bupivicaine|
338311|NCT00329745|B3|Baseline|Total|Total of all reporting groups
338312|NCT00329745|B2|Baseline|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
338313|NCT00329745|B1|Baseline|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
338314|NCT00329745|P2|Participant Flow|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
338315|NCT00329745|P1|Participant Flow|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
338316|NCT00329745|O2|Outcome|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
338317|NCT00329745|O1|Outcome|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
338318|NCT00329745|O2|Outcome|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
338319|NCT00329745|O1|Outcome|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
338320|NCT00329745|E2|Reported Event|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
338321|NCT00329745|E1|Reported Event|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
338328|NCT00329784|B3|Baseline|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
338329|NCT00329784|B2|Baseline|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338330|NCT00329784|B1|Baseline|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
338331|NCT00329784|P4|Participant Flow|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338332|NCT00329784|P3|Participant Flow|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
338333|NCT00329784|P2|Participant Flow|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338334|NCT00329784|P1|Participant Flow|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
338335|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338336|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
338337|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338338|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
338339|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338340|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
338341|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338342|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
338343|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338344|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
338345|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338346|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
338347|NCT00329784|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338348|NCT00329784|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
338383|NCT00329901|B3|Baseline|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
338384|NCT00329901|B2|Baseline|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
338385|NCT00329901|B1|Baseline|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338349|NCT00329784|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338350|NCT00329784|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
338351|NCT00329784|E4|Reported Event|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338352|NCT00329784|E3|Reported Event|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
338353|NCT00329784|E2|Reported Event|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
338354|NCT00329784|E1|Reported Event|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
338355|NCT00329836|B1|Baseline|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
338356|NCT00329836|P1|Participant Flow|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
338357|NCT00329836|O1|Outcome|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
338799|NCT00313703|E4|Reported Event|Other|Met other International Headache Society criteria
338358|NCT00329836|E1|Reported Event|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
338359|NCT00329849|B3|Baseline|Total|Total of all reporting groups
338360|NCT00329849|B2|Baseline|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
338361|NCT00329849|B1|Baseline|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
338362|NCT00329849|P2|Participant Flow|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
338363|NCT00329849|P1|Participant Flow|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
338364|NCT00329849|O4|Outcome|MenACWY-PS_6 to 10 Years|Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
338365|NCT00329849|O3|Outcome|MenACWY-CRM_6 to 10 Years|Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
338366|NCT00329849|O2|Outcome|MenACWY-PS_2 to 5 Years|Subjects ≥2 to ≤5 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
338367|NCT00329849|O1|Outcome|MenACWY-CRM_2 to 5 Years|Subjects ≥2 to ≤5 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
338368|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
338369|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
338370|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
338371|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
338372|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
338373|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
338374|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
338375|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
338376|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
338377|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
338378|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
338379|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
338380|NCT00329849|E2|Reported Event|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
338381|NCT00329849|E1|Reported Event|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
338382|NCT00329901|B4|Baseline|Total|Total of all reporting groups
339155|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
338388|NCT00329901|P1|Participant Flow|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338389|NCT00329901|O3|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
338390|NCT00329901|O2|Outcome|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
338391|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338392|NCT00329901|O2|Outcome|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
338393|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338394|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
338395|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338396|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
338397|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338398|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
338399|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338400|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
338401|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338402|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
338403|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338404|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
338405|NCT00329901|O1|Outcome|Tdap+ MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338406|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
338407|NCT00329901|O1|Outcome|Tdap+ MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338409|NCT00329901|O1|Outcome|Tdap+MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338410|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
338411|NCT00329901|O1|Outcome|Tdap+MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
338412|NCT00329901|E3|Reported Event|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
338413|NCT00329901|E2|Reported Event|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
338414|NCT00329901|E1|Reported Event|Tdap + MenACWY-CRM|Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms
338415|NCT00311155|B1|Baseline|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
338416|NCT00311155|P1|Participant Flow|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
338417|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
338418|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
338419|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
338508|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338509|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338420|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
338421|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
338422|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
338423|NCT00311155|E1|Reported Event|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
338424|NCT00311181|B1|Baseline|Group 1|
338425|NCT00311181|P1|Participant Flow|Group 1|
338426|NCT00311181|O1|Outcome|Group 1|
338427|NCT00311181|O1|Outcome|Group 1|
338428|NCT00311181|O1|Outcome|Group 1|
338429|NCT00311181|E1|Reported Event|Group 1|
338430|NCT00311311|B3|Baseline|Total|Total of all reporting groups
338490|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338431|NCT00311311|B2|Baseline|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338432|NCT00311311|B1|Baseline|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338433|NCT00311311|P2|Participant Flow|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to cyclosporine (CsA) (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338434|NCT00311311|P1|Participant Flow|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 nanogram per milliliter [ng/mL] by 3-6 months post-transplant) plus mycophenolate mofetil (MMF) (greater than or equal to [>=] 500 milligram per day [mg/day]) or mycophenolate sodium (MPS) (>= 360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or azathioprine (AZA) (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338435|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338436|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338510|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338511|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338437|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338438|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338439|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338440|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338489|NCT00311363|P1|Participant Flow|Single-blind (SB) GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn).
338997|NCT00314249|P1|Participant Flow|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
338441|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338442|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338443|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338444|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338445|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338446|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338447|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338512|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338513|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338448|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338449|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338450|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338451|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338452|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338453|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338454|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338455|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338456|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338457|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338458|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338570|NCT00311402|B1|Baseline|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338459|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338460|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338461|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338462|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338463|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338464|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338465|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338466|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338467|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338468|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338469|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338514|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338515|NCT00311363|O2|Outcome|DB GEn 1200mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338470|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338471|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338472|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338473|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338474|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338475|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338476|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338477|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338478|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338479|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338480|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338553|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
338554|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
338481|NCT00311311|E2|Reported Event|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
338482|NCT00311311|E1|Reported Event|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
338483|NCT00311363|B4|Baseline|Total|Total of all reporting groups
338484|NCT00311363|B3|Baseline|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet.
338485|NCT00311363|B2|Baseline|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet.
338486|NCT00311363|B1|Baseline|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn).
338487|NCT00311363|P3|Participant Flow|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet.
338488|NCT00311363|P2|Participant Flow|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet.
338491|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338492|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338493|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338494|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338495|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338496|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338497|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338498|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338499|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338500|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338501|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338502|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338503|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338504|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338505|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338506|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338507|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338555|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
338556|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
338516|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338517|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338518|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338519|NCT00311363|O2|Outcome|GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338520|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338521|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338522|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338523|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338524|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338525|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338526|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338527|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338528|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338529|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338530|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338531|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338532|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338533|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338534|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338535|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338536|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338537|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338538|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338539|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338540|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338541|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338542|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338543|NCT00311363|E3|Reported Event|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
338544|NCT00311363|E2|Reported Event|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
338545|NCT00311363|E1|Reported Event|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
338546|NCT00311376|B4|Baseline|Total|Total of all reporting groups
338547|NCT00311376|B3|Baseline|Placebo|Normal saline (placebo)
338548|NCT00311376|B2|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
338549|NCT00311376|B1|Baseline|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
338550|NCT00311376|P3|Participant Flow|Placebo|Normal saline (placebo)
338551|NCT00311376|P2|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
338552|NCT00311376|P1|Participant Flow|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
338572|NCT00311402|P1|Participant Flow|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338573|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
338574|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338575|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
338576|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338577|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
338578|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338579|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
338580|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338581|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
338582|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338583|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
338584|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338585|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
338586|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338587|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
338588|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338589|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
338590|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338591|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
338592|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338593|NCT00311402|E2|Reported Event|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
338594|NCT00311402|E1|Reported Event|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
338595|NCT00311584|B3|Baseline|Total|Total of all reporting groups
338596|NCT00311584|B2|Baseline|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
irinotecan hydrochloride : Given IV
temozolomide : Given IV"
338597|NCT00311584|B1|Baseline|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
irinotecan hydrochloride : Given IV
temozolomide : Given IV"
338598|NCT00311584|P2|Participant Flow|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
irinotecan hydrochloride : Given IV
temozolomide : Given IV"
338599|NCT00311584|P1|Participant Flow|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
irinotecan hydrochloride : Given IV
temozolomide : Given IV"
338600|NCT00311584|O2|Outcome|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
irinotecan hydrochloride : Given IV
temozolomide : Given IV"
338601|NCT00311584|O1|Outcome|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
irinotecan hydrochloride : Given IV
temozolomide : Given IV"
338602|NCT00311584|E2|Reported Event|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
irinotecan hydrochloride : Given IV
temozolomide : Given IV"
338603|NCT00311584|E1|Reported Event|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
irinotecan hydrochloride : Given IV
temozolomide : Given IV"
338604|NCT00311766|B3|Baseline|Total|Total of all reporting groups
339156|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
338605|NCT00311766|B2|Baseline|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days
Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
338606|NCT00311766|B1|Baseline|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days
Placebo : Topical administration, 0.00% qd up to 56 days"
338607|NCT00311766|P2|Participant Flow|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days
Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
338608|NCT00311766|P1|Participant Flow|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days
Placebo : Topical administration, 0.00% qd up to 56 days"
338609|NCT00311766|O2|Outcome|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days
Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
338610|NCT00311766|O1|Outcome|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days
Placebo : Topical administration, 0.00% qd up to 56 days"
338611|NCT00311766|O2|Outcome|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days
Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
338612|NCT00311766|O1|Outcome|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days
Placebo : Topical administration, 0.00% qd up to 56 days"
338613|NCT00311766|E2|Reported Event|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days
Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
338614|NCT00311766|E1|Reported Event|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days
Placebo : Topical administration, 0.00% qd up to 56 days"
338615|NCT00312195|B3|Baseline|Total|Total of all reporting groups
338616|NCT00312195|B2|Baseline|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
338617|NCT00312195|B1|Baseline|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
338618|NCT00312195|P2|Participant Flow|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
338619|NCT00312195|P1|Participant Flow|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
338620|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
338621|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
338622|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
338623|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
338624|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
338625|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
338626|NCT00312195|O3|Outcome|Total|Placebo and BTDS combined.
338627|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
338628|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
338629|NCT00312195|E3|Reported Event|Open-label Run-in Period BTDS 5, 10 or 20|Buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
338630|NCT00312195|E2|Reported Event|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
338631|NCT00312195|E1|Reported Event|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
338632|NCT00312208|B3|Baseline|Total|Total of all reporting groups
338633|NCT00312208|B2|Baseline|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
338634|NCT00312208|B1|Baseline|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
338635|NCT00312208|P2|Participant Flow|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
338636|NCT00312208|P1|Participant Flow|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
338637|NCT00312208|O2|Outcome|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
338638|NCT00312208|O1|Outcome|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
338639|NCT00312208|O2|Outcome|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
338703|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338640|NCT00312208|O1|Outcome|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
338641|NCT00312208|E2|Reported Event|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
338642|NCT00312208|E1|Reported Event|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
338643|NCT00312221|B4|Baseline|Total|Total of all reporting groups
338644|NCT00312221|B3|Baseline|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
338645|NCT00312221|B2|Baseline|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
338646|NCT00312221|B1|Baseline|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
338647|NCT00312221|P4|Participant Flow|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
338648|NCT00312221|P3|Participant Flow|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
338649|NCT00312221|P2|Participant Flow|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
338650|NCT00312221|P1|Participant Flow|Run-in Period|The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
338651|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
338652|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
338653|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
338654|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
338655|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
338656|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
338657|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
338658|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
338659|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
338660|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
338661|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
338662|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
338663|NCT00312221|E4|Reported Event|Run-in, Open-label BTDS 10 and 20|The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
338664|NCT00312221|E3|Reported Event|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours) during the 12-week double-blind phase.
338665|NCT00312221|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
338666|NCT00312221|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear during the 12-week double-blind phase
338667|NCT00313300|B6|Baseline|Total|Total of all reporting groups
338668|NCT00313300|B5|Baseline|Apixaban 20 mg QD|"Tablet of apixaban, oral, for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B, this treatment group was terminated."
338669|NCT00313300|B4|Baseline|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B, this treatment group was terminated"
338670|NCT00313300|B3|Baseline|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338671|NCT00313300|B2|Baseline|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338672|NCT00313300|B1|Baseline|Placebo|Tablet of Placebo for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338673|NCT00313300|P5|Participant Flow|Apixaban 20 mg QD|"Phase B of the Study: Tablet of Apixaban 20 mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B, the DSMB recommended that the apixaban 20 mg QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."
338674|NCT00313300|P4|Participant Flow|Apixaban 10mg BID|"Phase B of the Study: Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B, the DSMB recommended that the 10 mg BID QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the 10 mg BID apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."
338675|NCT00313300|P3|Participant Flow|Apixaban 10mg QD|In both Phase A and Phase B of the study: Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
338676|NCT00313300|P2|Participant Flow|Apixaban 2.5mg BID|In both Phase A and Phase B of the study: Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
338677|NCT00313300|P1|Participant Flow|Placebo|Study was conducted in 2 Phases (A and B). A tablet of Placebo along with ≤ 165 mg of aspirin was given daily for 26 weeks. 75 mg of clopidogrel once a day (QD) was allowed at the investigator’s discretion. After 547 subjects were randomized to Phase A, an independent Data and Safety Monitoring Board (DSMB) recommended expanding the randomization to 2 higher doses of apixaban (10 mg BID and 20 mg QD) in Phase B of the study. Approximately 6 months after the start of Phase B, the DSMB recommended apixaban high dose groups be terminated due to excess bleeding in those participants receiving aspirin and clopidogrel concomitantly with high dose apixaban. Treatment and any new randomization into these 2 groups was halted, while randomization and treatment in the placebo and lower dose apixaban groups continued. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
338678|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated."
338679|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated."
338680|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338681|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338682|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338683|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated."
338684|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated."
338685|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338686|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338687|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338688|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated."
338689|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated."
338690|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338691|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338692|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338693|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated."
338694|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated."
338695|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338696|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338697|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo, oral, for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338698|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated."
338699|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
Approximately 6 months after the start of Phase B this treatment group was terminated."
338700|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338701|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338702|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338750|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
338704|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338705|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338706|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338707|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338708|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338709|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338710|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338711|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338712|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338713|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338714|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338715|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338716|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
338717|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
339599|NCT00316017|B1|Baseline|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
338718|NCT00313300|E8|Reported Event|Phase B Placebo|Participants treated with at least one dose of Placebo during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
338719|NCT00313300|E7|Reported Event|Phase B Apixaban 2.5mg BID|Participants treated with at least one dose of 2.5 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
338720|NCT00313300|E6|Reported Event|Phase B Apixaban 20mg QD|Participants treated with at least one dose of 20 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
338721|NCT00313300|E5|Reported Event|Phase B Apixaban 10mg QD|Participants treated with at least one dose of 10 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
338722|NCT00313300|E4|Reported Event|Phase B Apixaban 10mg BID|Participants treated with at least one dose of 10 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
338723|NCT00313300|E3|Reported Event|Phase A+B Placebo|Total Phase A and Phase B participants combined who received at least 1 dose of placebo during the study.
338724|NCT00313300|E2|Reported Event|Phase A+B Apixaban 2.5mg BID|Total Phase A and Phase B participants combined who received at least 1 dose of 2.5 mg BID apixaban during the study.
338725|NCT00313300|E1|Reported Event|Phase A+B Apixaban 10mg QD|Total Phase A and Phase B participants combined who received at least 1 dose of 10 mg QD apixaban during the study.
338726|NCT00313313|B4|Baseline|Total|Total of all reporting groups
338727|NCT00313313|B3|Baseline|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
338728|NCT00313313|B2|Baseline|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338729|NCT00313313|B1|Baseline|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338730|NCT00313313|P3|Participant Flow|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
338731|NCT00313313|P2|Participant Flow|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338751|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
338752|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
338732|NCT00313313|P1|Participant Flow|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338733|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
338734|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338735|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338736|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
338737|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338766|NCT00313586|O3|Outcome|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
338738|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338739|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
338740|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338741|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338742|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
338743|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338744|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338745|NCT00313313|E3|Reported Event|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338746|NCT00313313|E2|Reported Event|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
338747|NCT00313313|E1|Reported Event|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
338748|NCT00313443|B1|Baseline|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
338749|NCT00313443|P1|Participant Flow|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
339157|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
338753|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
338754|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
338755|NCT00313443|E1|Reported Event|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
338756|NCT00313586|B5|Baseline|Total|Total of all reporting groups
338757|NCT00313586|B4|Baseline|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
338758|NCT00313586|B3|Baseline|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
338759|NCT00313586|B2|Baseline|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
338760|NCT00313586|B1|Baseline|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
338761|NCT00313586|P4|Participant Flow|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
338762|NCT00313586|P3|Participant Flow|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
338763|NCT00313586|P2|Participant Flow|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
338764|NCT00313586|P1|Participant Flow|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
338765|NCT00313586|O4|Outcome|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
338767|NCT00313586|O2|Outcome|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
338768|NCT00313586|O1|Outcome|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
338769|NCT00313586|E2|Reported Event|Arm B (Azacitidine + Entinostat)|Patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
338770|NCT00313586|E1|Reported Event|Arm A (Azacitidine)|Patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
338771|NCT00313612|B3|Baseline|Total|Total of all reporting groups
338772|NCT00313612|B2|Baseline|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV"
338773|NCT00313612|B1|Baseline|Treatment Stratum I: (Oxaliplatin Plus Topotecan)|"Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV"
338774|NCT00313612|P2|Participant Flow|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV"
338775|NCT00313612|P1|Participant Flow|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV"
338776|NCT00313612|O2|Outcome|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV"
338777|NCT00313612|O1|Outcome|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV"
338778|NCT00313612|O2|Outcome|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV"
338779|NCT00313612|O1|Outcome|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV"
339158|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
338780|NCT00313612|E2|Reported Event|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV"
338781|NCT00313612|E1|Reported Event|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV"
338782|NCT00313703|B5|Baseline|Total|Total of all reporting groups
338783|NCT00313703|B4|Baseline|Other|Met other International Headache Society criteria
338784|NCT00313703|B3|Baseline|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
338785|NCT00313703|B2|Baseline|Tension-type Headache|met International Headache Society tension-type headache criteria
338786|NCT00313703|B1|Baseline|Migraine|met International Headache Society migraine criteria
338787|NCT00313703|P4|Participant Flow|Other|Met other International Headache Society criteria
338788|NCT00313703|P3|Participant Flow|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
338789|NCT00313703|P2|Participant Flow|Tension-type Headache|met International Headache Society tension-type headache criteria
338790|NCT00313703|P1|Participant Flow|Migraine|met International Headache Society migraine criteria
338791|NCT00313703|O4|Outcome|Other|Met other International Headache Society criteria
338792|NCT00313703|O3|Outcome|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
338793|NCT00313703|O2|Outcome|Tension-type Headache|met International Headache Society tension-type headache criteria
338794|NCT00313703|O1|Outcome|Migraine|met International Headache Society migraine criteria
338795|NCT00313703|O4|Outcome|Other|Met other International Headache Society criteria
338796|NCT00313703|O3|Outcome|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
338797|NCT00313703|O2|Outcome|Tension-type Headache|met International Headache Society tension-type headache criteria
338800|NCT00313703|E3|Reported Event|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
338801|NCT00313703|E2|Reported Event|Tension-type Headache|met International Headache Society tension-type headache criteria
338802|NCT00313703|E1|Reported Event|Migraine|met International Headache Society migraine criteria
338803|NCT00313716|B7|Baseline|Total|Total of all reporting groups
338804|NCT00313716|B6|Baseline|Placebo/TT10 Arm|Patients received saline and transfused to keep hemoglobin concentration at least 10 g/dl
338805|NCT00313716|B5|Baseline|Epo2/TT10 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 10 g/dl
338806|NCT00313716|B4|Baseline|Epo1/TT10 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 10 g/dl
338807|NCT00313716|B3|Baseline|Placebo/TT7 Arm|Patients received saline and transfused to keep hemoglobin concentration at least 7 g/dl
338808|NCT00313716|B2|Baseline|Epo2/TT7 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 7 g/dl
338809|NCT00313716|B1|Baseline|Epo1/TT7 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 7 g/dl
338810|NCT00313716|P6|Participant Flow|Placebo/TT10 Arm|Placebo (patients received saline) and hemoglobin transfusion threshold 10 gm/dl
338811|NCT00313716|P5|Participant Flow|Epo2/TT10 Arm|Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
338812|NCT00313716|P4|Participant Flow|Epo1/TT10 Arm|High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
338813|NCT00313716|P3|Participant Flow|Placebo/TT7 Arm|Placebo (patients received saline) and hemoglobin transfusion threshold 7 gm/dl
338814|NCT00313716|P2|Participant Flow|Epo2/TT7 Arm|Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
338815|NCT00313716|P1|Participant Flow|Epo1/TT7 Arm|High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
338816|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 group, Epo2/TT10 group, and Placebo/TT10 group combined)
338817|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
338818|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
338819|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
338820|NCT00313716|O5|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
338821|NCT00313716|O4|Outcome|TT7 Group|Patients had hemoglobin maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
338822|NCT00313716|O3|Outcome|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
338823|NCT00313716|O2|Outcome|Epo2 Group|Patients received 500 IU/kg within 6 hrs after injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
338824|NCT00313716|O1|Outcome|Epo1 Group|Patients received 500 IU/kg erythropoietin within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
338825|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
338826|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
338827|NCT00313716|O5|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
338828|NCT00313716|O4|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
338829|NCT00313716|O3|Outcome|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
338830|NCT00313716|O2|Outcome|Epo2 Group|Patients received erythropoietin 500 IU/kg within 6hrs of injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
338831|NCT00313716|O1|Outcome|Epo1 Group|Patients received erythropoietin 500 IU/kg within 6hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
338832|NCT00313716|E5|Reported Event|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
338833|NCT00313716|E4|Reported Event|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
338834|NCT00313716|E3|Reported Event|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
338835|NCT00313716|E2|Reported Event|Epo2 Group|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
338836|NCT00313716|E1|Reported Event|Epo1 Group|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
338837|NCT00313781|B3|Baseline|Total|Total of all reporting groups
338838|NCT00313781|B2|Baseline|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
338862|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
338839|NCT00313781|B1|Baseline|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338840|NCT00313781|P3|Participant Flow|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
338841|NCT00313781|P2|Participant Flow|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
338842|NCT00313781|P1|Participant Flow|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion intravenously (IV) over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21 days cycle, up to 17 cycles.
338843|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
338844|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338845|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
338846|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338847|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
338848|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338849|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
338850|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338851|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
338852|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
338853|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338854|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
338855|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
338856|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338857|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
338858|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338859|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
338860|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338861|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
339600|NCT00316017|P3|Participant Flow|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
338863|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338864|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
338865|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338866|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
338867|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
338868|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338869|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
338870|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
338871|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338872|NCT00313781|E3|Reported Event|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
338873|NCT00313781|E2|Reported Event|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
338874|NCT00313781|E1|Reported Event|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
338875|NCT00313820|B3|Baseline|Total|Total of all reporting groups
338876|NCT00313820|B2|Baseline|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
339159|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
339160|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
338877|NCT00313820|B1|Baseline|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338878|NCT00313820|P2|Participant Flow|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338879|NCT00313820|P1|Participant Flow|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338880|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338881|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338936|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338882|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338883|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338884|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338885|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338886|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338887|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338888|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338889|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338890|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338891|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338892|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338893|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338894|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338895|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338896|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338897|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338898|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338899|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338900|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338901|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338902|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338903|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338904|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338905|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338906|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338907|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338908|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338909|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338910|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338911|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338912|NCT00313820|E2|Reported Event|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338913|NCT00313820|E1|Reported Event|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
338914|NCT00313846|B3|Baseline|Total|Total of all reporting groups
338915|NCT00313846|B2|Baseline|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
338916|NCT00313846|B1|Baseline|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
338917|NCT00313846|P2|Participant Flow|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
338918|NCT00313846|P1|Participant Flow|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
338919|NCT00313846|O2|Outcome|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
338920|NCT00313846|O1|Outcome|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
338921|NCT00313846|O2|Outcome|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
338922|NCT00313846|O1|Outcome|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
338923|NCT00313846|E3|Reported Event|Open-label Run-in Period BTDS 5, 10, or 20|Open-label Run-in Period (less than or equal to 21 days): All subjects began treatment on BTDS 5 and titrated to a maximum of BTDS 20 to achieve effective pain control. Subjects were treated for a minimum of 3 days with any given dose of BTDS before up-titration to the next strength patch was considered. One down-titration was permitted. Subjects meeting protocol-defined criteria for adequate analgesia within 21 days were eligible for entry into the double-blind phase.
338924|NCT00313846|E2|Reported Event|Double-blind BTDS 5, 10, or 20|Test treatments in the double-blind phase
338925|NCT00313846|E1|Reported Event|Double-blind Placebo Patch 5, 10, or 20|Reference treatment in the double-blind phase
338926|NCT00313911|B3|Baseline|Total|Total of all reporting groups
338927|NCT00313911|B2|Baseline|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338928|NCT00313911|B1|Baseline|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338929|NCT00313911|P2|Participant Flow|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338930|NCT00313911|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338931|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338932|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338933|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338934|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338935|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
339601|NCT00316017|P2|Participant Flow|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
338937|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338938|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338939|NCT00313911|E2|Reported Event|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338940|NCT00313911|E1|Reported Event|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
338941|NCT00314106|B3|Baseline|Total|Total of all reporting groups
338942|NCT00314106|B2|Baseline|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
338943|NCT00314106|B1|Baseline|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
338944|NCT00314106|P2|Participant Flow|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
338945|NCT00314106|P1|Participant Flow|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
338946|NCT00314106|O2|Outcome|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
338947|NCT00314106|O1|Outcome|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
338948|NCT00314106|O2|Outcome|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
338949|NCT00314106|O1|Outcome|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
338950|NCT00314106|E2|Reported Event|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
338994|NCT00314249|B2|Baseline|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
338995|NCT00314249|B1|Baseline|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
338996|NCT00314249|P2|Participant Flow|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
338951|NCT00314106|E1|Reported Event|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
338952|NCT00314132|B3|Baseline|Total|Total of all reporting groups
338953|NCT00314132|B2|Baseline|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
338954|NCT00314132|B1|Baseline|Placebo|Participants received a single injection of placebo on Day 0.
338955|NCT00314132|P2|Participant Flow|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
338956|NCT00314132|P1|Participant Flow|Placebo|Participants received a single injection of placebo on Day 0.
338957|NCT00314132|O2|Outcome|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
338958|NCT00314132|O1|Outcome|Placebo|Participants received a single injection of placebo on Day 0.
338959|NCT00314132|O2|Outcome|ChimeriVax™-JE 4 log10 PFU Vaccine|All participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
338960|NCT00314132|O1|Outcome|Placebo|All subjects received a single injection of placebo on Day 0.
338961|NCT00314132|E2|Reported Event|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
338962|NCT00314132|E1|Reported Event|Placebo|Participants received a single injection of placebo on Day 0.
338963|NCT00314145|B3|Baseline|Total|Total of all reporting groups
338964|NCT00314145|B2|Baseline|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
338965|NCT00314145|B1|Baseline|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
338966|NCT00314145|P2|Participant Flow|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
338967|NCT00314145|P1|Participant Flow|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
338968|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
338969|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
338970|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
338971|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
338972|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
338973|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
339161|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
339162|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
338974|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
338975|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
338976|NCT00314145|E2|Reported Event|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
338977|NCT00314145|E1|Reported Event|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
338978|NCT00314236|B3|Baseline|Total|Total of all reporting groups
338979|NCT00314236|B2|Baseline|Control|Microfracture alone
338980|NCT00314236|B1|Baseline|Experimental|BST-CarGel applied to a Microfractured lesion
338981|NCT00314236|P2|Participant Flow|Control|Microfracture alone
338982|NCT00314236|P1|Participant Flow|Experimental|BST-CarGel applied to a Microfractured lesion
338983|NCT00314236|O2|Outcome|Control|Microfracture alone
338984|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
338985|NCT00314236|O2|Outcome|Control|Microfracture alone
338986|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
338987|NCT00314236|O2|Outcome|Control|Microfracture alone
338988|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
338989|NCT00314236|O2|Outcome|Control|Microfracture alone
338990|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
338991|NCT00314236|E2|Reported Event|Control|Microfracture alone
338992|NCT00314236|E1|Reported Event|Experimental|BST-CarGel applied to a Microfractured lesion
338993|NCT00314249|B3|Baseline|Total|Total of all reporting groups
338998|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
338999|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
339000|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
339001|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
339002|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
339003|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
339004|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
339005|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
339006|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
339007|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
339008|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
339009|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
339010|NCT00314249|E2|Reported Event|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
339011|NCT00314249|E1|Reported Event|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
339012|NCT00314262|B1|Baseline|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.
Celecoxib given 400 mg orally BID continuously for 6 months."
339013|NCT00314262|P1|Participant Flow|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.
Celecoxib given 400 mg orally BID continuously for 6 months."
339014|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.
Celecoxib given 400 mg orally BID continuously for 6 months."
339015|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.
Celecoxib given 400 mg orally BID continuously for 6 months."
339016|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.
Celecoxib given 400 mg orally BID continuously for 6 months."
339017|NCT00314262|E1|Reported Event|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.
Celecoxib given 400 mg orally BID continuously for 6 months."
339039|NCT00314366|B1|Baseline|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339163|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
339018|NCT00314327|B1|Baseline|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
339019|NCT00314327|P1|Participant Flow|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
339020|NCT00314327|O1|Outcome|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
339021|NCT00314327|E1|Reported Event|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
339022|NCT00314340|B1|Baseline|Prescription Opioid Abusers|The subjective effects of the study drug were evaluated with the short form of the Addiction Research Center Inventory (ARCI. This inventory consists of 49 true/ false questions which survey major domains of drug effects. Participants indicated the pleasurable effects or desirability of the medications on 4 locally developed drug-liking ratings: craving, liking, strong desire, and “want more pain medication.” Ratings were made on a 100-mm VAS anchored with 0 at the low end and 10 at the high end. Participants also responded to 11 locally developed drug-effect ratings to assess psychoactive effects. Ratings were again made on a 100-mmVAS anchoredwith 0 at the lowend and 10 at the high end for:“on cloud 9,” “high,” “good drug effect,” “bad drug effect,” “impaired,”“stoned,” “sedated,” “confused,” “nauseated from,” “anxious,” and “down”. The rating levels over a six hour period were examined to explore the timing of these effects.
339023|NCT00314340|P1|Participant Flow|All Participants|All participants were randomized to receive the ER morphine tablets, 45 mg, hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg, or placebo in a 3 way cross over design.
339024|NCT00314340|O3|Outcome|Placebo|
339025|NCT00314340|O2|Outcome|Hydrocodone 30 mg Plus N-acetyl-para-aminophenol 975 mg|These findings all argue against the hypothesis that the hydrocodone product induced a greater euphoric or reinforcing effect than that of ER morphine.
339026|NCT00314340|O1|Outcome|ER Morphine Tablets, 45mg|Scores of the 5 Addiction Research Center Inventory dimensions did not change significantly between baseline and 300 min under any treatment condition.
339027|NCT00314340|E1|Reported Event|Prescription Opioid Abusers|The subjective effects of the study drug were evaluated with the short form of the Addiction Research Center Inventory (ARCI. This inventory consists of 49 true/ false questions which survey major domains of drug effects. Participants indicated the pleasurable effects or desirability of the medications on 4 locally developed drug-liking ratings: craving, liking, strong desire, and “want more pain medication.” Ratings were made on a 100-mm VAS anchored with 0 at the low end and 10 at the high end. Participants also responded to 11 locally developed drug-effect ratings to assess psychoactive effects. Ratings were again made on a 100-mmVAS anchoredwith 0 at the lowend and 10 at the high end for:“on cloud 9,” “high,” “good drug effect,” “bad drug effect,” “impaired,”“stoned,” “sedated,” “confused,” “nauseated from,” “anxious,” and “down”. The rating levels over a six hour period were examined to explore the timing of these effects.
339028|NCT00314353|B3|Baseline|Total|Total of all reporting groups
339029|NCT00314353|B2|Baseline|Capecitabine, Irinotecan, Bevacizumab|
339030|NCT00314353|B1|Baseline|Capecitabine, Oxaliplatin, Bevacizumab|
339031|NCT00314353|P2|Participant Flow|Capecitabine, Irinotecan, Bevacizumab|
339032|NCT00314353|P1|Participant Flow|Capecitabine, Oxaliplatin, Bevacizumab|
339033|NCT00314353|O2|Outcome|Capecitabine, Irinotecan, Bevacizumab|
339034|NCT00314353|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab|
339035|NCT00314353|E2|Reported Event|Capecitabine, Irinotecan, Bevacizumab|
339036|NCT00314353|E1|Reported Event|Capecitabine, Oxaliplatin, Bevacizumab|
339037|NCT00314366|B3|Baseline|Total|Total of all reporting groups
339038|NCT00314366|B2|Baseline|Control|"Control (Placebo) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339101|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
339102|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
339040|NCT00314366|P2|Participant Flow|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339041|NCT00314366|P1|Participant Flow|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339042|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339043|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339044|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339045|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339046|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339047|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339048|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339049|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339050|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339051|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339052|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339053|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339054|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339055|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339056|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339057|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339058|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339103|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
339059|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339060|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
At 6 months, subject is offered stem cell therapy and then followed for 12 months.
Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339061|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339062|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339063|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339064|NCT00314366|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
339065|NCT00314366|O1|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
At 6 months, subject is offered stem cell therapy and then followed for 12 months.
Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339066|NCT00314366|E2|Reported Event|Control|"Placebo (control) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.
Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
339067|NCT00314366|E1|Reported Event|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.
Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
339068|NCT00314574|B3|Baseline|Total|Total of all reporting groups
339069|NCT00314574|B2|Baseline|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339070|NCT00314574|B1|Baseline|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339071|NCT00314574|P2|Participant Flow|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339072|NCT00314574|P1|Participant Flow|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339073|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339074|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339075|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339104|NCT00314951|E2|Reported Event|Fidaxomicin|200 mg administered twice daily (q12hr)
339076|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339077|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339078|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339079|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339080|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339248|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339249|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339081|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339082|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339083|NCT00314574|E2|Reported Event|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339084|NCT00314574|E1|Reported Event|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.
Participants were permitted to use albuterol as rescue medicine throughout the study."
339085|NCT00314808|B1|Baseline|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
339086|NCT00314808|P1|Participant Flow|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
339087|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
339088|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
339089|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
339090|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
339091|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
339092|NCT00314808|E1|Reported Event|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
339093|NCT00314951|B3|Baseline|Total|Total of all reporting groups
339094|NCT00314951|B2|Baseline|Fidaxomicin|200 mg administered twice daily (q12hr)
339095|NCT00314951|B1|Baseline|Vancomycin|125 mg administered 4 times daily (q6hr)
339096|NCT00314951|P2|Participant Flow|Fidaxomicin|200 mg administered twice daily (q12hr)
339097|NCT00314951|P1|Participant Flow|Vancomycin|125 mg administered 4 times daily (q6hr)
339098|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
339099|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
339100|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
339107|NCT00315055|B2|Baseline|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339108|NCT00315055|B1|Baseline|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339109|NCT00315055|P2|Participant Flow|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339110|NCT00315055|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339111|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339112|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339113|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP IPV PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX®) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339250|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339602|NCT00316017|P1|Participant Flow|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339114|NCT00315055|O1|Outcome|DTaP-IPV-HB-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP IPV Hep B PRP T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339115|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP IPV PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX®) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339116|NCT00315055|O1|Outcome|DTaP-IPV-HB-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP IPV Hep B PRP T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339117|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339118|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339119|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339120|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339121|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX® PEDIATRIC|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339122|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339123|NCT00315055|E2|Reported Event|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339124|NCT00315055|E1|Reported Event|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
339125|NCT00315120|B5|Baseline|Total|Total of all reporting groups
339126|NCT00315120|B4|Baseline|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound physical therapy
339127|NCT00315120|B3|Baseline|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound physical therapy
339128|NCT00315120|B2|Baseline|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound physical therapy
339129|NCT00315120|B1|Baseline|OMT + UST|Active osteopathic manipulation and active ultrasound physical therapy
339130|NCT00315120|P4|Participant Flow|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound physical therapy
339131|NCT00315120|P3|Participant Flow|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound physical therapy
339132|NCT00315120|P2|Participant Flow|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound physical therapy
339133|NCT00315120|P1|Participant Flow|OMT + UST|Active osteopathic manipulation and active ultrasound physical therapy
339171|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
339172|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
339173|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
339174|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound therapy
339175|NCT00315120|O1|Outcome|Active UST|Active ultrasound therapy
339176|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
339177|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
339178|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
339179|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
339180|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
339181|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
339182|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
339183|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
339184|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
339185|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
339186|NCT00315120|E4|Reported Event|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound therapy
339187|NCT00315120|E3|Reported Event|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound therapy
339188|NCT00315120|E2|Reported Event|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound therapy
339189|NCT00315120|E1|Reported Event|OMT + UST|Active osteopathic manipulation and active ultrasound therapy
339190|NCT00315146|B5|Baseline|Total|Total of all reporting groups
339251|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339252|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339191|NCT00315146|B4|Baseline|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
339192|NCT00315146|B3|Baseline|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
339193|NCT00315146|B2|Baseline|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
339194|NCT00315146|B1|Baseline|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
339195|NCT00315146|P4|Participant Flow|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
339230|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339231|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339232|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339233|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339196|NCT00315146|P3|Participant Flow|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
339197|NCT00315146|P2|Participant Flow|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
339603|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339198|NCT00315146|P1|Participant Flow|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
339199|NCT00315146|O4|Outcome|Hypocaloric Diet,Resistance Training, Pioglitazone/Actos™|"Pioglitazone
Resistance exercise training to maximize muscle power
Hypocaloric diet"
339200|NCT00315146|O3|Outcome|Hypocaloric Diet and a PPAR- γ Agonist (Pioglitazone/Actos™)|"Pioglitazone
Hypocaloric diet"
339201|NCT00315146|O2|Outcome|Hypocaloric Diet, Resist. Training to Maximize Power, Placebo|"Resistance exercise training to maximize muscle power
Hypocaloric diet
Placebo"
339202|NCT00315146|O1|Outcome|Hypocaloric Diet (and Placebo)|"Hypocaloric diet
Placebo"
339203|NCT00315146|O4|Outcome|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
339204|NCT00315146|O3|Outcome|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
339205|NCT00315146|O2|Outcome|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
339206|NCT00315146|O1|Outcome|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
339234|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339235|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339236|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339207|NCT00315146|E4|Reported Event|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
339208|NCT00315146|E3|Reported Event|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
339209|NCT00315146|E2|Reported Event|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
339210|NCT00315146|E1|Reported Event|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
339211|NCT00315302|B5|Baseline|Total|Total of all reporting groups
339212|NCT00315302|B4|Baseline|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339213|NCT00315302|B3|Baseline|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339214|NCT00315302|B2|Baseline|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339215|NCT00315302|B1|Baseline|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339216|NCT00315302|P4|Participant Flow|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339217|NCT00315302|P3|Participant Flow|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339218|NCT00315302|P2|Participant Flow|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339219|NCT00315302|P1|Participant Flow|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339220|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339221|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339222|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339223|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339224|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339225|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339226|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339227|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339228|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339229|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339237|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339238|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339239|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339240|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339241|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339242|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339243|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339244|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339245|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339246|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339247|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339253|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339254|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339255|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339256|NCT00315302|E4|Reported Event|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
339257|NCT00315302|E3|Reported Event|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
339258|NCT00315302|E2|Reported Event|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339259|NCT00315302|E1|Reported Event|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
339260|NCT00315328|B5|Baseline|Total|Total of all reporting groups
339261|NCT00315328|B4|Baseline|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339262|NCT00315328|B3|Baseline|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339263|NCT00315328|B2|Baseline|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339264|NCT00315328|B1|Baseline|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339265|NCT00315328|P4|Participant Flow|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339266|NCT00315328|P3|Participant Flow|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339267|NCT00315328|P2|Participant Flow|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339268|NCT00315328|P1|Participant Flow|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339269|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339270|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339271|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339272|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339273|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339342|NCT00315445|B4|Baseline|Total|Total of all reporting groups
339274|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339275|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339276|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339277|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339278|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339279|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339280|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339281|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339282|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339283|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339284|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339285|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339286|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339287|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339288|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339289|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339290|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339291|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339292|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339293|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339294|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339295|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339296|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339297|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339298|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339299|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339300|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339301|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339302|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339303|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339304|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339305|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339306|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339307|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339308|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339309|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339310|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339311|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339312|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339313|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339314|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339315|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339316|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339317|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339318|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339319|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339320|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339321|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339604|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339322|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339323|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339324|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339325|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339326|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339327|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339328|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339329|NCT00315328|E4|Reported Event|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
339330|NCT00315328|E3|Reported Event|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
339331|NCT00315328|E2|Reported Event|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
339332|NCT00315328|E1|Reported Event|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
339333|NCT00315341|B3|Baseline|Total|Total of all reporting groups
339334|NCT00315341|B2|Baseline|Methadone|
339335|NCT00315341|B1|Baseline|Buprenorphine/Nx|
339336|NCT00315341|P2|Participant Flow|Methadone|The mean dose of methadone was 93.2 mg.
339337|NCT00315341|P1|Participant Flow|Buprenorphine/Nx|Participants received medication for 24 weeks in the active phase of the study. The mean dose of buprenorphine was 22.3 mg. Blood samples for measurement of liver function were taken at baseline and at Weeks 1, 2, 4 8, 12, 16, 20, and 24 with follow-up at Week 32.
339338|NCT00315341|O2|Outcome|Methadone|
339339|NCT00315341|O1|Outcome|Buprenorphine/Nx|
339340|NCT00315341|E2|Reported Event|Methadone|For the MET group, all participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant’s clinical need with no specific upper limit. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.
339341|NCT00315341|E1|Reported Event|Buprenorphine/Nx|For the BUP/NX group, all participants will receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg buprenorphine increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant’s clinical need. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.
339343|NCT00315445|B3|Baseline|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339344|NCT00315445|B2|Baseline|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339345|NCT00315445|B1|Baseline|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339346|NCT00315445|P3|Participant Flow|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339347|NCT00315445|P2|Participant Flow|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339348|NCT00315445|P1|Participant Flow|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339349|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339350|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339351|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339352|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339353|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339354|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339355|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339356|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339357|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339358|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339359|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339360|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339361|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339362|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339363|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339364|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339365|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339366|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339367|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339368|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339369|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339370|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339371|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339372|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339373|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339374|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339375|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339376|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339377|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339378|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339379|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339380|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339381|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339382|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339383|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339384|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339385|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339386|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339387|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339388|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339389|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339390|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339391|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339392|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339393|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339394|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339395|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339396|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339397|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339398|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339399|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339400|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339401|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339402|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339403|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339404|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339405|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339406|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339407|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339408|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339409|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339410|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339605|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339411|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339412|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339413|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339414|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339415|NCT00315445|E3|Reported Event|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
339416|NCT00315445|E2|Reported Event|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
339417|NCT00315445|E1|Reported Event|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
339418|NCT00315458|B3|Baseline|Total|Total of all reporting groups
339419|NCT00315458|B2|Baseline|Double-blind BTDS|Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
339420|NCT00315458|B1|Baseline|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
339421|NCT00315458|P4|Participant Flow|Extension Phase BTDS 5/10/20|Subjects who finished the entire 12-week (84-day) double-blind phase were eligible to participate in the open-label extension phase. Subjects began treatment with BTDS 5 and their doses were titrated to BTDS 10 or BTDS 20 as needed.
339422|NCT00315458|P3|Participant Flow|Run-in Period BTDS 5/10/20|All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.
339423|NCT00315458|P2|Participant Flow|Double-blind BTDS 10/20|Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
339424|NCT00315458|P1|Participant Flow|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
339425|NCT00315458|O4|Outcome|Overall BTDS Exposure|Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.
339426|NCT00315458|O3|Outcome|Run-in Period|All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.
339427|NCT00315458|O2|Outcome|Double-blind BTDS|Test treatment buprenoprhine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
339428|NCT00315458|O1|Outcome|Double-blind Placebo|Reference treatment placebo 10 or 20 applied for 7-day wear
339429|NCT00315458|E4|Reported Event|Overall BTDS Exposure|Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.
339430|NCT00315458|E3|Reported Event|Run-in Period|Open-label Run-in period (BTDS 5, 10, or 20) applied for 7-day wear
339431|NCT00315458|E2|Reported Event|Double-blind BTDS 10/20|Test treatment buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
339432|NCT00315458|E1|Reported Event|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
339433|NCT00315588|B1|Baseline|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant
339434|NCT00315588|P1|Participant Flow|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant.
339435|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with a previous kidney transplant
339436|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant.
339437|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with a previous kidney transplant.
339438|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant.
339439|NCT00315588|E1|Reported Event|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant
339440|NCT00315614|B1|Baseline|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
339441|NCT00315614|P1|Participant Flow|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
339442|NCT00315614|O1|Outcome|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
339443|NCT00315614|O1|Outcome|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
339444|NCT00315614|O1|Outcome|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
339445|NCT00315614|O1|Outcome|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
339446|NCT00315614|E1|Reported Event|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
339447|NCT00315627|B1|Baseline|Islet Transplantation|Islet transplantation: Islet transplantation
339448|NCT00315627|P1|Participant Flow|Islet Transplantation|Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
339449|NCT00315627|O1|Outcome|Islet Transplantation|Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
339450|NCT00315627|O1|Outcome|Islet Transplantation|"Islet Alone Transplantation under Alentuzumab (Campath1H) induction.
Islet transplantation: Islet transplantation"
339451|NCT00315627|O1|Outcome|Islet Transplantation|Islet Alone Transplantation under Alentuzumab (Campath1H) induction.
339452|NCT00315627|O1|Outcome|Islet Transplantation|Islet Alone Transplantation under Alentuzumab (Campath1H) induction.
339606|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339453|NCT00315627|O1|Outcome|Islet Transplantation|Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
339454|NCT00315627|E1|Reported Event|Islet Transplantation|Islet transplantation alone under alentuzumab (Campath1H) induction.
339455|NCT00315705|B3|Baseline|Total|Total of all reporting groups
339456|NCT00315705|B2|Baseline|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
339457|NCT00315705|B1|Baseline|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
339458|NCT00315705|P1|Participant Flow|Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2. > Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
339459|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
339460|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
339461|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
339462|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
339463|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
339464|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
339465|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
339466|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
339467|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
339468|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
339469|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
339470|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
339471|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
339472|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339473|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339474|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339475|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
339476|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
339477|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339478|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339479|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339480|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
339481|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
339482|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339483|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339484|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339485|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
339486|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
339487|NCT00315705|E7|Reported Event|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
339488|NCT00315705|E6|Reported Event|Phase 1 - Total|All participants from Cohorts 1-5 in Phase 1
339489|NCT00315705|E5|Reported Event|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339490|NCT00315705|E4|Reported Event|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339491|NCT00315705|E3|Reported Event|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
339492|NCT00315705|E2|Reported Event|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
339493|NCT00315705|E1|Reported Event|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
339494|NCT00315731|B1|Baseline|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339495|NCT00315731|P1|Participant Flow|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339496|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339497|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339498|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339499|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339500|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339501|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339521|NCT00315822|B2|Baseline|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen
80% oxygen: Supplemental oxygen will be administered during surgery"
339522|NCT00315822|B1|Baseline|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen
30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
339502|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339503|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339504|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339505|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339506|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339557|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339558|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
365790|NCT00402987|O3|Outcome|Placebo|
339507|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339508|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339509|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339523|NCT00315822|P2|Participant Flow|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen
80% oxygen: Supplemental oxygen will be administered during surgery"
339524|NCT00315822|P1|Participant Flow|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen
30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
339525|NCT00315822|O2|Outcome|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen
80% oxygen: Supplemental oxygen will be administered during surgery"
339510|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339511|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339512|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339513|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339514|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339515|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339516|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339517|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339518|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339519|NCT00315731|E1|Reported Event|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
339520|NCT00315822|B3|Baseline|Total|Total of all reporting groups
339526|NCT00315822|O1|Outcome|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen
30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
339527|NCT00315822|E2|Reported Event|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen
80% oxygen: Supplemental oxygen will be administered during surgery"
339528|NCT00315822|E1|Reported Event|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen
30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
339529|NCT00315939|B3|Baseline|Total|Total of all reporting groups
339530|NCT00315939|B2|Baseline|Experimental: Group B Order: IBMF-1, IBMF-2, SMBG|Group B will begin with level 2, followed by level 3 and then level 1. Each level will continue for 3 months.
339531|NCT00315939|B1|Baseline|Experimental: Group A Order: SMBG, IBMF-1, IBMF-2|Group A will perform routine SMBG alone (level 1), followed sequentially by levels 2 and 3. Each level continued for 3 months.
339532|NCT00315939|P2|Participant Flow|Experimental: Group B Order: IBMF-1, IBMF-2, SMBG|Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 followed by IBMF-2, level 3 and then SMBG only. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
339533|NCT00315939|P1|Participant Flow|Experimental: Group A Order: SMBG, IBMF-1, IBMF-2|Self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 and IBMF-2, level 3. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
339534|NCT00315939|O1|Outcome|Experimental Groups A and B|"Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.
Each level continued for 3 months.
IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.
IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure."
339636|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
375767|NCT00425698|B2|Baseline|Placebo|
339535|NCT00315939|O1|Outcome|Experimental Groups A and B|"Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.
Each level continued for 3 months.
IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.
IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure."
339536|NCT00315939|E2|Reported Event|IBMF-2|IBMF-2 retains level 2, but the HHC asks subjects to provide symptom ratings when BG (blood glucose) is low and at an equal number of matching euglycemic readings. From these data, the HHC estimates a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
339537|NCT00315939|E1|Reported Event|IBMF-1|IBMF-1 will use the OneTouch® UltraSmart® glucometer (LifeScan, Milpitas, CA) to collect routine SMBG data and the subject transfers the blood glucose (BG) value into a hand-held computer (HHC) for processing. As the subject checks BG on a daily basis, the IBMF-1 software calculates an estimate of HbA1c, acute risk for hypoglycemia and chronic risk for hypoglycemia. This information will be presented back to the subject. Specifically, (i) alarms for immediate action if BG<50 mg/dL is registered; (ii) a running HbA1c estimate (71); (iii) a warning to be more careful and measure BG more frequently over the next 24 hours if elevated acute risk for hypoglycemia is found, and (iv) an indication of the subject's chronic risk for hypoglycemia in one of 4 categories (minimal, low, moderate, and high). At moderate and high risk the subject will be prompted to consider altering his/her behavior. HbA1c and chronic risk change slowly (2-3 weeks), while acute risk can change daily.
339538|NCT00316004|B4|Baseline|Total|Total of all reporting groups
339539|NCT00316004|B3|Baseline|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339540|NCT00316004|B2|Baseline|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339598|NCT00316017|B2|Baseline|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339607|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339541|NCT00316004|B1|Baseline|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339542|NCT00316004|P3|Participant Flow|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339543|NCT00316004|P2|Participant Flow|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339544|NCT00316004|P1|Participant Flow|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339545|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339546|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339547|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339548|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339549|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339550|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339551|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339552|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339553|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339554|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339555|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339556|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339637|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
380370|NCT00415597|O1|Outcome|ALO-01|
339559|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339560|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339561|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339562|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339563|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339564|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339565|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339566|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339567|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339568|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339569|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339570|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339571|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339572|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339573|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339574|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339575|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339576|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339577|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339578|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339579|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339580|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339581|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339582|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339583|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339584|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339585|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339638|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339639|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339586|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339587|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339588|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339589|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339590|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339591|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339592|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339593|NCT00316004|E3|Reported Event|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339594|NCT00316004|E2|Reported Event|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339595|NCT00316004|E1|Reported Event|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
339596|NCT00316017|B4|Baseline|Total|Total of all reporting groups
339597|NCT00316017|B3|Baseline|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339608|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339609|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339610|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339611|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339612|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339613|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339614|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339615|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339616|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339617|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339618|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339619|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339620|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339621|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339622|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339623|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339624|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339625|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339626|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339627|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339628|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339629|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339630|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339631|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339632|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339633|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339634|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339635|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339640|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339641|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339642|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339643|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339644|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339645|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339646|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339647|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339648|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339649|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339650|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339651|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339652|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339653|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339654|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339655|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339656|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339657|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339658|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339659|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339660|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339661|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339662|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339663|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339664|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339665|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339666|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339667|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339668|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339669|NCT00316017|E3|Reported Event|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
339670|NCT00316017|E2|Reported Event|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
339671|NCT00316017|E1|Reported Event|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
339672|NCT00316303|B3|Baseline|Total|Total of all reporting groups
339730|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339673|NCT00316303|B2|Baseline|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
339674|NCT00316303|B1|Baseline|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
339675|NCT00316303|P2|Participant Flow|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
339676|NCT00316303|P1|Participant Flow|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
339677|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
339678|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
339679|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
339680|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
339681|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
339682|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
340308|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
339683|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A and hepatitis B immunizations, and any necessary treatments.
339684|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
339685|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
339686|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
339687|NCT00316303|E2|Reported Event|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
339688|NCT00316303|E1|Reported Event|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
339689|NCT00316355|B3|Baseline|Total|Total of all reporting groups
339690|NCT00316355|B2|Baseline|Stepped-Care CBT|"Stepped-care CBT
Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
339691|NCT00316355|B1|Baseline|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
Traditional CBT: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
339692|NCT00316355|P2|Participant Flow|Stepped-Care CBT|"Stepped-care CBT
Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
339693|NCT00316355|P1|Participant Flow|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
339731|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339694|NCT00316355|O2|Outcome|Stepped-Care CBT|"Stepped-care CBT
Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
339695|NCT00316355|O1|Outcome|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
339696|NCT00316355|O2|Outcome|Stepped-Care CBT|"Stepped-care CBT
Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
339697|NCT00316355|O1|Outcome|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
339698|NCT00316355|E2|Reported Event|Stepped-Care CBT|"Stepped-care CBT
Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
339699|NCT00316355|E1|Reported Event|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
339700|NCT00316693|B3|Baseline|Total|Total of all reporting groups
339701|NCT00316693|B2|Baseline|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339702|NCT00316693|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339703|NCT00316693|P2|Participant Flow|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339704|NCT00316693|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339705|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339706|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339707|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339859|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339708|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339709|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339710|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339711|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339712|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339713|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339714|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339715|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339716|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339717|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339718|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339719|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339720|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339721|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339722|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339723|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339724|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339725|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339726|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339727|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339728|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339729|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339732|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339733|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339734|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339735|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339736|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339737|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339738|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339739|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339740|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339741|NCT00316693|E2|Reported Event|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
339742|NCT00316693|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
339743|NCT00316706|B3|Baseline|Total|Total of all reporting groups
339744|NCT00316706|B2|Baseline|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
339745|NCT00316706|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
339746|NCT00316706|P2|Participant Flow|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
339747|NCT00316706|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
339748|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
339749|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
339750|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
339751|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
339752|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
339753|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
339754|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
339755|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
339756|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
339757|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
339758|NCT00316706|E2|Reported Event|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
339759|NCT00316706|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
339760|NCT00316719|B3|Baseline|Total|Total of all reporting groups
339761|NCT00316719|B2|Baseline|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339762|NCT00316719|B1|Baseline|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339763|NCT00316719|P2|Participant Flow|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339764|NCT00316719|P1|Participant Flow|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339765|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339766|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339767|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339768|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339769|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339770|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339771|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339772|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339773|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339774|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
340498|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
339775|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339776|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339777|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339778|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339779|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339780|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339781|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339782|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339783|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339784|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339785|NCT00316719|E2|Reported Event|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
339786|NCT00316719|E1|Reported Event|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
339787|NCT00316862|B1|Baseline|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
339788|NCT00316862|P1|Participant Flow|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
339816|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339817|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339789|NCT00316862|O1|Outcome|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
339790|NCT00316862|O1|Outcome|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
339791|NCT00316862|O1|Outcome|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
339792|NCT00316862|E1|Reported Event|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
339793|NCT00316888|B3|Baseline|Total|Total of all reporting groups
339832|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339833|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339794|NCT00316888|B2|Baseline|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339795|NCT00316888|B1|Baseline|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339796|NCT00316888|P2|Participant Flow|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339797|NCT00316888|P1|Participant Flow|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339798|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339799|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339818|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339800|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339801|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339802|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339803|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339804|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339834|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339835|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339805|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339806|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339807|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339808|NCT00316888|E2|Reported Event|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339809|NCT00316888|E1|Reported Event|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
cisplatin: Given IV
fluorouracil: Given IV
radiation therapy: Given once daily 5 days a week for 5 weeks"
339810|NCT00316914|B3|Baseline|Total|Total of all reporting groups
339811|NCT00316914|B2|Baseline|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339812|NCT00316914|B1|Baseline|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339813|NCT00316914|P2|Participant Flow|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339814|NCT00316914|P1|Participant Flow|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339815|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339860|NCT00317044|O3|Outcome|Placebo|Placebo
339819|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339820|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339821|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339822|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339823|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339824|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339825|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339826|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339827|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339828|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339829|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339830|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339831|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339836|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339837|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339838|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339839|NCT00316914|E2|Reported Event|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339840|NCT00316914|E1|Reported Event|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
339841|NCT00317044|B4|Baseline|Total|Total of all reporting groups
339842|NCT00317044|B3|Baseline|Placebo|Placebo
339843|NCT00317044|B2|Baseline|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339844|NCT00317044|B1|Baseline|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339845|NCT00317044|P3|Participant Flow|Placebo|Placebo
339846|NCT00317044|P2|Participant Flow|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339847|NCT00317044|P1|Participant Flow|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339848|NCT00317044|O3|Outcome|Placebo|Placebo
339849|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339850|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339851|NCT00317044|O3|Outcome|Placebo|Placebo
339852|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339853|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339854|NCT00317044|O3|Outcome|Placebo|Placebo
339855|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339856|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339857|NCT00317044|O3|Outcome|Placebo|Placebo
339858|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
340309|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
339861|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339862|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339863|NCT00317044|O3|Outcome|Placebo|Placebo
339864|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339865|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339866|NCT00317044|O3|Outcome|Placebo|Placebo
339867|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339868|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339869|NCT00317044|O3|Outcome|Placebo|Placebo
339870|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339871|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339872|NCT00317044|O3|Outcome|Placebo|Placebo
339873|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339874|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339875|NCT00317044|O3|Outcome|Placebo|Placebo
339876|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339877|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339878|NCT00317044|O3|Outcome|Placebo|Placebo
339879|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339880|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339881|NCT00317044|O3|Outcome|Placebo|Placebo
339882|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339883|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339884|NCT00317044|O3|Outcome|Placebo|Placebo
339885|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339886|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339887|NCT00317044|E3|Reported Event|Placebo|Placebo
339888|NCT00317044|E2|Reported Event|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
339889|NCT00317044|E1|Reported Event|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
339890|NCT00317109|B3|Baseline|Total|Total of all reporting groups
339933|NCT00317239|B1|Baseline|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
339891|NCT00317109|B2|Baseline|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339892|NCT00317109|B1|Baseline|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339893|NCT00317109|P2|Participant Flow|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339894|NCT00317109|P1|Participant Flow|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339895|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339896|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339947|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
415198|NCT00525174|O2|Outcome|Patching|
339897|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339898|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339899|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339900|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339901|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339902|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339934|NCT00317239|P2|Participant Flow|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
339935|NCT00317239|P1|Participant Flow|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
339936|NCT00317239|O2|Outcome|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
345238|NCT00344487|O1|Outcome|Kaletra|
339903|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339904|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339905|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339906|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339907|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339908|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339909|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339963|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339910|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339911|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339912|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339913|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339914|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339915|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339916|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339917|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339918|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339919|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339920|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339921|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339922|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339979|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
415199|NCT00525174|O1|Outcome|Bangerter|
339923|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339924|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339925|NCT00317109|E2|Reported Event|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339926|NCT00317109|E1|Reported Event|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
339927|NCT00317226|B1|Baseline|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
339928|NCT00317226|P1|Participant Flow|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
339929|NCT00317226|O1|Outcome|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
339930|NCT00317226|E1|Reported Event|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
339931|NCT00317239|B3|Baseline|Total|Total of all reporting groups
339932|NCT00317239|B2|Baseline|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
359119|NCT00381303|O1|Outcome|Female|
339937|NCT00317239|O1|Outcome|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
339938|NCT00317239|E2|Reported Event|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
339939|NCT00317239|E1|Reported Event|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
339940|NCT00317642|B3|Baseline|Total|Total of all reporting groups
339941|NCT00317642|B2|Baseline|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339942|NCT00317642|B1|Baseline|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339943|NCT00317642|P2|Participant Flow|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339944|NCT00317642|P1|Participant Flow|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339945|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339946|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340310|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
415200|NCT00525174|O2|Outcome|Patching|
339948|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339949|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339950|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339951|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339952|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339953|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339954|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339955|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339956|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339957|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339958|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339959|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339960|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339961|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339962|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340311|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
340312|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
339964|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339965|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339966|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339967|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339968|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339969|NCT00317642|O2|Outcome|Placebo and Cytarabine (FAS)|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339970|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine (FAS)|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339971|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339972|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339973|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339974|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339975|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339976|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339977|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339978|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340313|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
340314|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
339980|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339981|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339982|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339983|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339984|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339985|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339986|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339987|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339988|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339989|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339990|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339991|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339992|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339993|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339994|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340039|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
339995|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339996|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339997|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
339998|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
339999|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
340000|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340001|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
340002|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340003|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
340004|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340005|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
340006|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340007|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
340008|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340009|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
340040|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340315|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
340010|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340011|NCT00317642|O2|Outcome|Placebo and Cytarabine (FAS)|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
340012|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine (FAS)|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340013|NCT00317642|E3|Reported Event|Overall|Combined total for the two Arms/Groups
340014|NCT00317642|E2|Reported Event|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
340015|NCT00317642|E1|Reported Event|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
340016|NCT00317720|B1|Baseline|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg given orally daily.
340017|NCT00317720|P2|Participant Flow|BIDMC/DFCI Trastuzumab + RAD001|"Phase I: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 5 or 10 mg by mouth daily.
Phase II: RAD001 10 mg/kg daily
ClinicalTrials.gov ID NCT00458237"
340018|NCT00317720|P1|Participant Flow|MDACC Trastuzumab + RAD001|"Phase I: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 (Everolimus) 10 mg orally (PO) daily.
Phase II: RAD001 10 mg/kg daily + Trastuzumab 6 mg/kg maintenance dose
ClinicalTrials.gov ID: NCT00317720"
340019|NCT00317720|O1|Outcome|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
340020|NCT00317720|O1|Outcome|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
340229|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
359120|NCT00381303|O7|Outcome|Other|
340021|NCT00317720|E1|Reported Event|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
340022|NCT00317941|B3|Baseline|Total|Total of all reporting groups
340023|NCT00317941|B2|Baseline|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340024|NCT00317941|B1|Baseline|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340025|NCT00317941|P3|Participant Flow|Group C: IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340026|NCT00317941|P2|Participant Flow|Group B: IFNB-1b 250 Mcg (Betaseron) Via Betaject Light|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
340027|NCT00317941|P1|Participant Flow|Group A: IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
340028|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340029|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340030|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340031|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340032|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340033|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
340034|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340035|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
340036|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340037|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
340038|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340041|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340042|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340043|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340044|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340045|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340046|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340047|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340048|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340049|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340050|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340051|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340052|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340053|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340054|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340055|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340056|NCT00317941|O3|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340057|NCT00317941|O2|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject Light|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
340230|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
340058|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
340059|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340060|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340061|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340062|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340063|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
340064|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
340065|NCT00317941|E2|Reported Event|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II. Participants at risk from Group C in Participant flow.
340066|NCT00317941|E1|Reported Event|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light. Participants at risk from Group A and Group B in Participant flow.
340067|NCT00318136|B1|Baseline|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
340068|NCT00318136|P1|Participant Flow|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
340069|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
340070|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
340071|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
340072|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
340316|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
340073|NCT00318136|E1|Reported Event|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
340074|NCT00318292|B3|Baseline|Total|Total of all reporting groups
340075|NCT00318292|B2|Baseline|Placebo|Placebo for preemptive local analgesia.
340076|NCT00318292|B1|Baseline|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
340077|NCT00318292|P2|Participant Flow|Placebo|Placebo for preemptive local analgesia.
340078|NCT00318292|P1|Participant Flow|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
340079|NCT00318292|O2|Outcome|Placebo|Placebo for preemptive local analgesia.
340080|NCT00318292|O1|Outcome|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
340081|NCT00318292|E2|Reported Event|Placebo|Placebo for preemptive local analgesia.
340082|NCT00318292|E1|Reported Event|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
340083|NCT00318370|B1|Baseline|Far Only and Chemo Plus Far and Maintenance Far Only|"Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far."
340084|NCT00318370|P3|Participant Flow|Maintenance Far Only|Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed Period 2, Chemo Plus Far.
340085|NCT00318370|P2|Participant Flow|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
340086|NCT00318370|P1|Participant Flow|Far Only|Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
340087|NCT00318370|O1|Outcome|Chemo Plus Far Plus Maintenance Far Only|"Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
Maintenace Far Only: farletuzumab, 100 mg/m2"
340088|NCT00318370|O1|Outcome|Chemo Plus Far Plus Maintenance Far Only|"Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
Maintenace Far Only: farletuzumab, 100 mg/m2"
340089|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
340134|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340090|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
340091|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
340092|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
340093|NCT00318370|O1|Outcome|Far Only|Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
340094|NCT00318370|E1|Reported Event|Far Only and Chemo Plus Far and Maintenance Far Only|"Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far."
340095|NCT00318409|B3|Baseline|Total|Total of all reporting groups
340096|NCT00318409|B2|Baseline|Placebo|Placebo 300mg daily
340097|NCT00318409|B1|Baseline|Bupropion|Bupropion XL 300mg daily
340098|NCT00318409|P2|Participant Flow|Placebo|Placebo 300mg daily
340099|NCT00318409|P1|Participant Flow|Bupropion|Bupropion XL 300mg daily
340100|NCT00318409|O2|Outcome|Placebo|
340101|NCT00318409|O1|Outcome|Bupropion|
340102|NCT00318409|O2|Outcome|Placebo|
340103|NCT00318409|O1|Outcome|Bupropion|
340104|NCT00318409|O2|Outcome|Placebo|
340105|NCT00318409|O1|Outcome|Bupropion|
340106|NCT00318409|O2|Outcome|Placebo|
340107|NCT00318409|O1|Outcome|Bupropion|
340108|NCT00318409|O2|Outcome|Placebo|
340109|NCT00318409|O1|Outcome|Bupropion|
340110|NCT00318409|O2|Outcome|Placebo|
340111|NCT00318409|O1|Outcome|Bupropion|
340112|NCT00318409|O2|Outcome|Placebo|
340113|NCT00318409|O1|Outcome|Bupropion|
340114|NCT00318409|O1|Outcome|Persons Screened|
340115|NCT00318409|E2|Reported Event|Placebo|
340116|NCT00318409|E1|Reported Event|Bupropion|
340117|NCT00318461|B6|Baseline|Total|Total of all reporting groups
340118|NCT00318461|B5|Baseline|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340119|NCT00318461|B4|Baseline|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340120|NCT00318461|B3|Baseline|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340317|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
415201|NCT00525174|O1|Outcome|Bangerter|
340121|NCT00318461|B2|Baseline|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340122|NCT00318461|B1|Baseline|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340123|NCT00318461|P5|Participant Flow|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340124|NCT00318461|P4|Participant Flow|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340125|NCT00318461|P3|Participant Flow|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340126|NCT00318461|P2|Participant Flow|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340127|NCT00318461|P1|Participant Flow|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340128|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340129|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340130|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340131|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340132|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340133|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340135|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340136|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340137|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340138|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340139|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340140|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340141|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340142|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340143|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340144|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340145|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340146|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340147|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340148|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340318|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
415202|NCT00525174|O2|Outcome|Patching|
340149|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340150|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340151|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340152|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340153|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340154|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340155|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340156|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340157|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340158|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340159|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340160|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340161|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340162|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340163|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340164|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340165|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340166|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340167|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340168|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340169|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340170|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340171|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340172|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340173|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340174|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340175|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340176|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340319|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
340320|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
340177|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340178|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340179|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340180|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340181|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340182|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340183|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340184|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340185|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340186|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340187|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340188|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340189|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340190|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340191|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340192|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340193|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340194|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340195|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340196|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340197|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340198|NCT00318461|E5|Reported Event|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340199|NCT00318461|E4|Reported Event|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340200|NCT00318461|E3|Reported Event|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340201|NCT00318461|E2|Reported Event|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340202|NCT00318461|E1|Reported Event|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
340203|NCT00318474|B3|Baseline|Total|Total of all reporting groups
340204|NCT00318474|B2|Baseline|Placebo|Subjects receive ACEi and FOS and placebo.
340205|NCT00318474|B1|Baseline|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.
Mycophenolate Mofetil (MMF)"
340206|NCT00318474|P2|Participant Flow|Placebo|Subjects receive ACEi and FOS and placebo.
340207|NCT00318474|P1|Participant Flow|Mycophenolate Mofetil (MMF)|"Subjects receive angiotensin-converting enzyme inhibitors (ACEi), fish oil supplements (FOS), and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.
Mycophenolate Mofetil (MMF)"
340208|NCT00318474|O2|Outcome|Placebo|Subjects receive ACEi and FOS and placebo.
340209|NCT00318474|O1|Outcome|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.
Mycophenolate Mofetil (MMF)"
340210|NCT00318474|E2|Reported Event|Placebo|Subjects receive ACEi and FOS and placebo.
340211|NCT00318474|E1|Reported Event|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.
Mycophenolate Mofetil (MMF)"
340212|NCT00318565|B1|Baseline|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
340213|NCT00318565|P1|Participant Flow|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
340214|NCT00318565|O1|Outcome|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
340215|NCT00318565|O1|Outcome|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
340216|NCT00318565|E1|Reported Event|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
340217|NCT00318591|B3|Baseline|Total|Total of all reporting groups
340218|NCT00318591|B2|Baseline|Conveen Uncoated|Uncoated intermittent catheter
340219|NCT00318591|B1|Baseline|SpeediCath|Hydrophilic coated intermittent catheter
340220|NCT00318591|P2|Participant Flow|Conveen Uncoated|Uncoated intermittent catheter
340221|NCT00318591|P1|Participant Flow|SpeediCath|Hydrophilic coated intermittent catheter
340222|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
340223|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
340224|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
340225|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
340226|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
340227|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
340228|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
340231|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
340232|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
340233|NCT00318591|O1|Outcome|SpeediCath Catheter|Hydrophilic coated intermittent catheter
340234|NCT00318591|O2|Outcome|Conveen Uncoated|uncoated intermittent catheter
340235|NCT00318591|O1|Outcome|SpeediCath Catheter|Hydrophilic coated intermittent catheter
340236|NCT00318591|E2|Reported Event|Conveen Uncoated|Uncoated intermittent catheter
340237|NCT00318591|E1|Reported Event|SpeediCath|Hydrophilic coated intermittent catheter
340238|NCT00318656|B3|Baseline|Total|Total of all reporting groups
340239|NCT00318656|B2|Baseline|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340240|NCT00318656|B1|Baseline|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340241|NCT00318656|P2|Participant Flow|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340242|NCT00318656|P1|Participant Flow|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of Rosiglitazone (RSG) and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340256|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340321|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
340322|NCT00312377|E2|Reported Event|Placebo Plus Docetaxel|Placebo plus docetaxel
340552|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
340243|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340244|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340245|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340246|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340247|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340248|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340276|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340277|NCT00318708|B3|Baseline|Total|Total of all reporting groups
340249|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340250|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340251|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340252|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340253|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340254|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340255|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
415203|NCT00525174|O1|Outcome|Bangerter|
340257|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340258|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340259|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340260|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340261|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340262|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340263|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340264|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340265|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340266|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340267|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340268|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340269|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
415204|NCT00525174|O2|Outcome|Patching|
340270|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340271|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340272|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340273|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340274|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
340275|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study
Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
340278|NCT00318708|B2|Baseline|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
340279|NCT00318708|B1|Baseline|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
340280|NCT00318708|P2|Participant Flow|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
340281|NCT00318708|P1|Participant Flow|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
340282|NCT00318708|O2|Outcome|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
340283|NCT00318708|O1|Outcome|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
340284|NCT00318708|E2|Reported Event|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
340285|NCT00318708|E1|Reported Event|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
340286|NCT00312338|B3|Baseline|Total|Total of all reporting groups
340287|NCT00312338|B2|Baseline|Healthy Subjects|Healthy Subjects
340288|NCT00312338|B1|Baseline|Infected Patients|Infected Patients
340289|NCT00312338|P2|Participant Flow|Healthy Subjects|Healthy Subjects
340290|NCT00312338|P1|Participant Flow|Infected Patients|Infected Patients
340291|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
340292|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
340293|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
340294|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
340295|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
340296|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
340297|NCT00312338|E2|Reported Event|Healthy Subjects|Healthy Subjects
340298|NCT00312338|E1|Reported Event|Infected Patients|Infected Patients
340299|NCT00312377|B3|Baseline|Total|Total of all reporting groups
340300|NCT00312377|B2|Baseline|Placebo Plus Docetaxel|Placebo plus docetaxel
340301|NCT00312377|B1|Baseline|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
340302|NCT00312377|P2|Participant Flow|Placebo Plus Docetaxel|Placebo tablet taken once daily plus docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
340303|NCT00312377|P1|Participant Flow|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg oral tablet taken once daily in combination with docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
340304|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
340305|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
340306|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
340307|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
340323|NCT00312377|E1|Reported Event|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
340324|NCT00312494|B4|Baseline|Total|Total of all reporting groups
340325|NCT00312494|B3|Baseline|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340326|NCT00312494|B2|Baseline|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340327|NCT00312494|B1|Baseline|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340328|NCT00312494|P3|Participant Flow|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340329|NCT00312494|P2|Participant Flow|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340330|NCT00312494|P1|Participant Flow|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340331|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340332|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340333|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340334|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340335|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340336|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340337|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340338|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340339|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340340|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340341|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340342|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340343|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340344|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340345|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340346|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340347|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340348|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340349|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340350|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340351|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340499|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
340352|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340353|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340354|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340355|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340356|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340357|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340358|NCT00312494|E3|Reported Event|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
340359|NCT00312494|E2|Reported Event|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
340360|NCT00312494|E1|Reported Event|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
340361|NCT00312572|B3|Baseline|Total|Total of all reporting groups
340362|NCT00312572|B2|Baseline|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
340363|NCT00312572|B1|Baseline|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
340364|NCT00312572|P2|Participant Flow|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
340365|NCT00312572|P1|Participant Flow|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
340366|NCT00312572|O3|Outcome|Combined Total|Combined percentages from BTDS 10/20 and BTDS 20
340367|NCT00312572|O2|Outcome|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
340368|NCT00312572|O1|Outcome|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
340369|NCT00312572|E3|Reported Event|Open-label Run-in Period - Vicodin|N = 266 subjects received a stable regimen of Vicodin® in the Run-in period and were eligible for randomization if they reported a daily “average pain over the last 24 hours” score of 0 = none or 1 = mild on at least 5 of the 7 days; and used ≤ 2 doses of supplemental analgesic per day for their osteoarthritic (OA) pain. N = 204 completed the run-in.
340470|NCT00312923|O1|Outcome|Treatment Group|"20 mg daily of policosanol
Policosanol : 20 mg of policosanol in capsular form daily"
415205|NCT00525174|O1|Outcome|Bangerter|
340370|NCT00312572|E2|Reported Event|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
340371|NCT00312572|E1|Reported Event|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
340372|NCT00312728|B1|Baseline|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
340373|NCT00312728|P1|Participant Flow|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
340374|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
340375|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
340376|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
340377|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
340378|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
340379|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
340380|NCT00312728|E1|Reported Event|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
340381|NCT00312845|B3|Baseline|Total|Total of all reporting groups
340382|NCT00312845|B2|Baseline|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
340383|NCT00312845|B1|Baseline|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
340384|NCT00312845|P2|Participant Flow|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
340385|NCT00312845|P1|Participant Flow|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
340386|NCT00312845|O2|Outcome|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
359121|NCT00381303|O6|Outcome|Asian|
340387|NCT00312845|O1|Outcome|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
340388|NCT00312845|O2|Outcome|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
340389|NCT00312845|O1|Outcome|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
340390|NCT00312845|E2|Reported Event|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
340391|NCT00312845|E1|Reported Event|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
340392|NCT00312858|B3|Baseline|Total|Total of all reporting groups
340393|NCT00312858|B2|Baseline|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340394|NCT00312858|B1|Baseline|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340395|NCT00312858|P2|Participant Flow|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340396|NCT00312858|P1|Participant Flow|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340397|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340398|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340399|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340400|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340401|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340402|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340403|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340404|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340405|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340406|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340407|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340450|NCT00312884|P2|Participant Flow|Usual Care|Received usual hospital care with no Telemonitoring
340500|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
340501|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
340502|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
340408|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340409|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340410|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340411|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340412|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340413|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340414|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340415|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340416|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340417|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340418|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340471|NCT00312923|E2|Reported Event|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
340419|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340420|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340421|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340422|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340423|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340424|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340425|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340426|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340427|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340428|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340429|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340430|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340431|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340432|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340433|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340434|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340435|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340436|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340437|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340438|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340472|NCT00312923|E1|Reported Event|Treatment Group|"20 mg daily of policosanol
Policosanol : 20 mg of policosanol in capsular form daily"
340439|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340440|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340441|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340442|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340443|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340444|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340445|NCT00312858|E2|Reported Event|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
340446|NCT00312858|E1|Reported Event|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
340447|NCT00312884|B3|Baseline|Total|Total of all reporting groups
340448|NCT00312884|B2|Baseline|Intervention Arm|Received daily home monitoring
340449|NCT00312884|B1|Baseline|Usual Care|Recieved usual follow-up care
359122|NCT00381303|O5|Outcome|Hispanic|
340451|NCT00312884|P1|Participant Flow|Intervention Arm|Recieved home telemonitoring daily HomMed Telemonitoring System: The HomeMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
340452|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring
HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
340453|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care
HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
340454|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring
HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
340455|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care
HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
340456|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring
HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
340457|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care
HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
340458|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring
HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
340459|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care
HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
340460|NCT00312884|E2|Reported Event|Intervention Arm|Recieved telemonitoring daily via the HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
340461|NCT00312884|E1|Reported Event|Usual Care|Recieved usual hospital care
340462|NCT00312923|B3|Baseline|Total|Total of all reporting groups
340463|NCT00312923|B2|Baseline|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
340464|NCT00312923|B1|Baseline|Treatment Group|"20 mg daily of policosanol
Policosanol : 20 mg of policosanol in capsular form daily"
340465|NCT00312923|P2|Participant Flow|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
340466|NCT00312923|P1|Participant Flow|Treatment Group|"20 mg daily of policosanol
Policosanol : 20 mg of policosanol in capsular form daily"
340467|NCT00312923|O2|Outcome|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
340468|NCT00312923|O1|Outcome|Treatment Group|"20 mg daily of policosanol
Policosanol : 20 mg of policosanol in capsular form daily"
340469|NCT00312923|O2|Outcome|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
340473|NCT00313014|B4|Baseline|Total|Total of all reporting groups
340474|NCT00313014|B3|Baseline|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
340475|NCT00313014|B2|Baseline|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
340476|NCT00313014|B1|Baseline|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
340477|NCT00313014|P3|Participant Flow|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
340478|NCT00313014|P2|Participant Flow|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
340479|NCT00313014|P1|Participant Flow|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
340480|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
340481|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
340482|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
340483|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
340484|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
340485|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
340486|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
340487|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
340488|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
340489|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
340490|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
340491|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
340492|NCT00313014|E4|Reported Event|Open-label Run-in Period, BTDS 10/20|Open-label BTDS 10 or 20 mcg/h applied for 7-day wear
340493|NCT00313014|E3|Reported Event|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
340494|NCT00313014|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
340495|NCT00313014|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
340496|NCT00313144|B1|Baseline|Overall Study|
340497|NCT00313144|P1|Participant Flow|Overall Study|Participants were treated with ARALAST according to dose and frequency of infusions recommended by their physician.
340503|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
340504|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
340505|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
340506|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
340507|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
340508|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
340509|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
340510|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
340511|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
340512|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
340513|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340514|NCT00313144|O1|Outcome|Year Prior to Baseline|
340515|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
340516|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
340517|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
340518|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340519|NCT00313144|O1|Outcome|Year Prior to Baseline|
340520|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
340521|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
340522|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
340523|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340524|NCT00313144|O1|Outcome|Year Prior to Baseline|
340525|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
340526|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
340527|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
340528|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340529|NCT00313144|O1|Outcome|Year Prior to Baseline|
340530|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
340531|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
340532|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
340533|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
340534|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
340535|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
340536|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
340537|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
340538|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
340539|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
340540|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
340541|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340542|NCT00313144|O1|Outcome|Year Prior to Baseline|
340543|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
340544|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
340545|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
340546|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
340547|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
340548|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
340549|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
340550|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340551|NCT00313144|O1|Outcome|Baseline|
340553|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
340554|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340555|NCT00313144|O1|Outcome|Baseline|
340556|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
340557|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340558|NCT00313144|O1|Outcome|Baseline|
340559|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340560|NCT00313144|O1|Outcome|Baseline|
340561|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340562|NCT00313144|O1|Outcome|Baseline|
340563|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340564|NCT00313144|O1|Outcome|Baseline|
340565|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340566|NCT00313144|O1|Outcome|Baseline|
340567|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340568|NCT00313144|O1|Outcome|Baseline|
340569|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340570|NCT00313144|O1|Outcome|Baseline|
340571|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340572|NCT00313144|O1|Outcome|Baseline|
340573|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340574|NCT00313144|O1|Outcome|Baseline|
340575|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340576|NCT00313144|O1|Outcome|Baseline|
340577|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
340578|NCT00313144|O1|Outcome|Baseline|
340579|NCT00313144|E1|Reported Event|Overall Study|
340580|NCT00313170|B4|Baseline|Total|Total of all reporting groups
340581|NCT00313170|B3|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
340582|NCT00313170|B2|Baseline|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
340583|NCT00313170|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg
340584|NCT00313170|P3|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
340585|NCT00313170|P2|Participant Flow|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
340586|NCT00313170|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg
340587|NCT00313170|O1|Outcome|Fulvestrant|Fulvestrant arms pooled
340588|NCT00313170|O1|Outcome|Fulvestrant|Fulvestrant arms pooled
340589|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
340590|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
340591|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
340592|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
340593|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
340594|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
340595|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
340596|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
340597|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
359123|NCT00381303|O4|Outcome|Caucasian|
340598|NCT00313170|E3|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
340599|NCT00313170|E2|Reported Event|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
340600|NCT00313170|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg
340601|NCT00313209|B3|Baseline|Total|Total of all reporting groups
340602|NCT00313209|B2|Baseline|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340603|NCT00313209|B1|Baseline|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340604|NCT00313209|P2|Participant Flow|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340605|NCT00313209|P1|Participant Flow|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340606|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340607|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340608|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340609|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340610|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340611|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340612|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340613|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340614|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340615|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340616|NCT00313209|E2|Reported Event|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340617|NCT00313209|E1|Reported Event|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
340618|NCT00330161|B1|Baseline|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
340691|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
340692|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
340619|NCT00330161|P1|Participant Flow|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
340620|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
340621|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
340622|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
340623|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
340653|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
340654|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
340655|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
340656|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
340657|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
340658|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
340659|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
340624|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
340625|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
340626|NCT00330161|E1|Reported Event|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
340627|NCT00330174|B3|Baseline|Total|Total of all reporting groups
340628|NCT00330174|B2|Baseline|Placebo|Matching placebo tablets
340629|NCT00330174|B1|Baseline|Acamprosate|Acamprosate tablets
340630|NCT00330174|P2|Participant Flow|Placebo|Matching placebo tablets
340631|NCT00330174|P1|Participant Flow|Acamprosate|Acamprosate tablets
340632|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
340633|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
340634|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
340635|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
340636|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
340637|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
340638|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
340639|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
340640|NCT00330174|E2|Reported Event|Placebo|Matching placebo tablets
340641|NCT00330174|E1|Reported Event|Acamprosate|Acamprosate tablets
340642|NCT00330421|B1|Baseline|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.
laboratory biomarker analysis : Correlative studies
sorafenib tosylate : Given PO
pharmacological study : Correlative studies
computed tomography : Correlative studies
dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
340693|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
340748|NCT00330876|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
340749|NCT00330876|E2|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
340643|NCT00330421|P2|Participant Flow|Group I (Sarcomas of Extremity)|Patients receive oral sorafenib twice daily on days 1-14. Patients undergo surgical resection of the tumor on approximately day 15. Once patients recover from surgery (and radiotherapy if indicated), patients who demonstrate a clinically and pathologically significant response (≥ 25% reduction in tumor size or ≥ 25% necrosis in the surgical specimen) may continue sorafenib as above for a maximum of 6 months in the absence of disease progression or unacceptable toxicity and at the discretion of the principal investigator. Biopsy tissue and blood samples are examined for biomarkers and interstitial fluid pressure (IFP) is measured at baseline and immediately before surgery.
340644|NCT00330421|P1|Participant Flow|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.
laboratory biomarker analysis : Correlative studies
sorafenib tosylate : Given PO
pharmacological study : Correlative studies
computed tomography : Correlative studies
dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
340645|NCT00330421|O1|Outcome|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.
laboratory biomarker analysis : Correlative studies
sorafenib tosylate : Given PO
pharmacological study : Correlative studies
computed tomography : Correlative studies
dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
340646|NCT00330421|E1|Reported Event|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.
laboratory biomarker analysis : Correlative studies
sorafenib tosylate : Given PO
pharmacological study : Correlative studies
computed tomography : Correlative studies
dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
340647|NCT00330460|B3|Baseline|Total|Total of all reporting groups
340648|NCT00330460|B2|Baseline|Denosumab 60 mg Q6M|
340649|NCT00330460|B1|Baseline|Alendronate 70 mg QW|
340650|NCT00330460|P2|Participant Flow|Denosumab 60 mg Q6M|
340651|NCT00330460|P1|Participant Flow|Alendronate 70 mg QW|
340652|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
340660|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
340661|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
340662|NCT00330460|E2|Reported Event|Denosumab 60 mg Q6M|
340663|NCT00330460|E1|Reported Event|Alendronate 70 mg QW|
340664|NCT00330564|B1|Baseline|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
340665|NCT00330564|P1|Participant Flow|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
340666|NCT00330564|O1|Outcome|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
340667|NCT00330564|O1|Outcome|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
340668|NCT00330564|E1|Reported Event|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
340669|NCT00330616|B1|Baseline|Bupropion SR|
340670|NCT00330616|P1|Participant Flow|Bupropion SR|Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
340671|NCT00330616|O1|Outcome|Bupropion SR|
340672|NCT00330616|O1|Outcome|Bupropion SR|
340673|NCT00330616|O1|Outcome|Bupropion SR|
340674|NCT00330616|O1|Outcome|Bupropion SR|
340675|NCT00330616|O1|Outcome|Bupropion SR|
340676|NCT00330616|O1|Outcome|Bupropion SR|
340677|NCT00330616|O1|Outcome|Bupropion SR|
340678|NCT00330616|O1|Outcome|Bupropion SR|
340679|NCT00330616|O1|Outcome|Bupropion SR|
340680|NCT00330616|O1|Outcome|Bupropion SR|
340681|NCT00330616|O1|Outcome|Bupropion SR|
340682|NCT00330616|O1|Outcome|Bupropion SR|
340683|NCT00330616|O1|Outcome|Bupropion SR|
340684|NCT00330616|O1|Outcome|Bupropion SR|
340685|NCT00330616|O1|Outcome|Bupropion SR|
340686|NCT00330616|O1|Outcome|Bupropion SR|
340687|NCT00330616|E1|Reported Event|Bupropion SR|Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
340688|NCT00330668|B1|Baseline|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
340689|NCT00330668|P1|Participant Flow|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
340690|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
340747|NCT00330876|O2|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
340694|NCT00330668|E1|Reported Event|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
340695|NCT00330681|B3|Baseline|Total|Total of all reporting groups
340696|NCT00330681|B2|Baseline|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340697|NCT00330681|B1|Baseline|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340698|NCT00330681|P2|Participant Flow|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340699|NCT00330681|P1|Participant Flow|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340700|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340701|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340702|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340703|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340704|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340705|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340706|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340707|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340708|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340709|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340710|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340711|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340712|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340713|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340714|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340715|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340716|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340717|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340718|NCT00330681|E2|Reported Event|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
340719|NCT00330681|E1|Reported Event|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
340720|NCT00330733|B3|Baseline|Total|Total of all reporting groups
340721|NCT00330733|B2|Baseline|Arm 2|"Salsalate
Salsalate: Salsalate therapy, double-masked"
340722|NCT00330733|B1|Baseline|Arm 1|"Matching placebo
Placebo: Matching placebo"
340723|NCT00330733|P2|Participant Flow|Arm 2|"Salsalate
Salsalate: Salsalate therapy"
340724|NCT00330733|P1|Participant Flow|Arm 1|"Matching placebo
Placebo: Matching placebo
Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication"
340725|NCT00330733|O2|Outcome|Arm 2|"Salsalate
Salsalate: Salsalate therapy"
340726|NCT00330733|O1|Outcome|Arm 1|"Matching placebo
Placebo: Matching placebo"
340727|NCT00330733|E2|Reported Event|Arm 2|"Salsalate
Salsalate: Salsalate therapy The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded > mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred."
340728|NCT00330733|E1|Reported Event|Arm 1|"Matching placebo
Placebo: Matching placebo The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded > mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred."
340729|NCT00330759|B3|Baseline|Total|Total of all reporting groups
340730|NCT00330759|B2|Baseline|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
340731|NCT00330759|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
340732|NCT00330759|P2|Participant Flow|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
340733|NCT00330759|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
340734|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
340735|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
340736|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
340737|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
340738|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
340739|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
340740|NCT00330759|E2|Reported Event|Denosumab 120 mg Q4W|
340741|NCT00330759|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
340742|NCT00330876|B1|Baseline|Safety Population|Subjects who received at least one dose of Pitavastatin 2 or 4 mg once daily
340743|NCT00330876|P2|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
340744|NCT00330876|P1|Participant Flow|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
340745|NCT00330876|O2|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
340746|NCT00330876|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
415206|NCT00525174|O2|Outcome|Patching|
340750|NCT00330876|E1|Reported Event|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
340751|NCT00330915|B1|Baseline|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
340752|NCT00330915|P1|Participant Flow|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
340753|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
340754|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
340755|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
340756|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
340757|NCT00330915|E1|Reported Event|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
340758|NCT00330928|B1|Baseline|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
340759|NCT00330928|P1|Participant Flow|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
340760|NCT00330928|O1|Outcome|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
340761|NCT00330928|O1|Outcome|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
340762|NCT00330928|E1|Reported Event|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
340763|NCT00330967|B3|Baseline|Total|Total of all reporting groups
340764|NCT00330967|B2|Baseline|Group 2|"Femoral Intralipid infusion subjects
20% Intralipid: lipid infusion"
340765|NCT00330967|B1|Baseline|Group 1|"Systemic Intralipid infusion subjects
20% Intralipid: lipid infusion"
340766|NCT00330967|P2|Participant Flow|Group 2|"Femoral arterial Intralipid infusion subjects
20% Intralipid: lipid infusion"
340767|NCT00330967|P1|Participant Flow|Group 1|"Systemic Intralipid infusion subjects
20% Intralipid: lipid infusion"
340768|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
340769|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
340770|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
340771|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
340772|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
340773|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
340774|NCT00330967|O1|Outcome|Group 2|"Femoral Intralipid infusion subjects
20% Intralipid: lipid infusion"
340775|NCT00330967|E2|Reported Event|Group 2|"Femoral Intralipid infusion group
20% Intralipid: lipid infusion"
340776|NCT00330967|E1|Reported Event|Group 1|"Systemic Intralipid infusion group
20% Intralipid: lipid infusion"
340777|NCT00331006|B1|Baseline|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
340778|NCT00331006|P1|Participant Flow|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
340952|NCT00332241|E2|Reported Event|Placebo|
340779|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
340780|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
340781|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
340782|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
340783|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
340784|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
340785|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
340786|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
340787|NCT00331006|E1|Reported Event|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
340788|NCT00331409|B1|Baseline|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth
Imatinib Mesylate: 600 mg daily by mouth"
340789|NCT00331409|P1|Participant Flow|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth
Imatinib Mesylate: 600 mg daily by mouth"
340790|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth
Imatinib Mesylate: 600 mg daily by mouth"
340791|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth
Imatinib Mesylate: 600 mg daily by mouth"
340792|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth
Imatinib Mesylate: 600 mg daily by mouth"
340793|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth
Imatinib Mesylate: 600 mg daily by mouth"
340794|NCT00331409|E1|Reported Event|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth
Imatinib Mesylate: 600 mg daily by mouth"
340795|NCT00331422|B1|Baseline|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
340796|NCT00331422|P1|Participant Flow|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
340797|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
340798|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
340971|NCT00332488|B1|Baseline|TI Inhalation Powder Alone|
341079|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
340799|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
340800|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
340801|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
340802|NCT00331422|O1|Outcome|Evaluable Patients (Received 4 Cycles of Therapy and Surgery)|Includes patients treated with 4 cycles of study chemotherapy regimen and surgery.
340803|NCT00331422|E1|Reported Event|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
340804|NCT00331552|B3|Baseline|Total|Total of all reporting groups
340805|NCT00331552|B2|Baseline|Phase II: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340806|NCT00331552|B1|Baseline|Phase I: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340807|NCT00331552|P2|Participant Flow|Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340823|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
flavopiridol: Given IV
docetaxel: Given IV"
340953|NCT00332241|E1|Reported Event|Aripiprazole|
340808|NCT00331552|P1|Participant Flow|Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340809|NCT00331552|O2|Outcome|Less Heavily Pre-treated|no regimens for advanced disease
340810|NCT00331552|O1|Outcome|Heavily Pre-treated|1 or more regimens for advanced disease
340811|NCT00331552|O1|Outcome|Phase II: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340812|NCT00331552|O1|Outcome|Phase II: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340813|NCT00331552|O1|Outcome|Phase II: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340814|NCT00331552|O2|Outcome|Doxil 35 mg/m^2|"Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340815|NCT00331552|O1|Outcome|Doxil 30 mg/m^2|"Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340816|NCT00331552|O1|Outcome|Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
341080|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341081|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
340817|NCT00331552|O1|Outcome|Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340818|NCT00331552|O1|Outcome|Phase I: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340819|NCT00331552|E2|Reported Event|Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340820|NCT00331552|E1|Reported Event|Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV"
340821|NCT00331682|B1|Baseline|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
flavopiridol: Given IV
docetaxel: Given IV"
340822|NCT00331682|P1|Participant Flow|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
alvocidib: Given IV
docetaxel: Given IV"
340858|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340824|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
flavopiridol: Given IV
docetaxel: Given IV"
340825|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
flavopiridol: Given IV
docetaxel: Given IV"
340826|NCT00331682|E1|Reported Event|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
flavopiridol: Given IV
docetaxel: Given IV"
340827|NCT00331760|B3|Baseline|Total|Total of all reporting groups
340828|NCT00331760|B2|Baseline|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
340829|NCT00331760|B1|Baseline|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
340830|NCT00331760|P2|Participant Flow|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
340831|NCT00331760|P1|Participant Flow|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
340832|NCT00331760|O2|Outcome|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
340833|NCT00331760|O1|Outcome|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
340834|NCT00331760|E2|Reported Event|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
340835|NCT00331760|E1|Reported Event|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
340836|NCT00331773|B3|Baseline|Total|Total of all reporting groups
340837|NCT00331773|B2|Baseline|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340838|NCT00331773|B1|Baseline|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340839|NCT00331773|P2|Participant Flow|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340840|NCT00331773|P1|Participant Flow|Conventional 3D-CRT|Conventional 3D-CRT or intensity-modulated radiotherapy (IMRT): Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340841|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340842|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340843|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
415207|NCT00525174|O1|Outcome|Bangerter|
340844|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340845|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340846|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340847|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340848|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340849|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340850|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340851|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340852|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340853|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340854|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340855|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340856|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340857|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
359124|NCT00381303|O3|Outcome|Black|
340859|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340860|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340861|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340862|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340863|NCT00331773|E2|Reported Event|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
340864|NCT00331773|E1|Reported Event|Conventional 3D-CRT|CConventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
340865|NCT00331799|B1|Baseline|Open Label Treatment|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
340866|NCT00331799|P1|Participant Flow|Open Label Treatment With Duloxetine|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg / day .
340867|NCT00331799|O1|Outcome|Duloxetine|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
340868|NCT00331799|E1|Reported Event|Open Label Treatment|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
340869|NCT00331864|B3|Baseline|Total|Total of all reporting groups
340870|NCT00331864|B2|Baseline|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340871|NCT00331864|B1|Baseline|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340872|NCT00331864|P2|Participant Flow|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340873|NCT00331864|P1|Participant Flow|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
341579|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
340874|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340875|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340876|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340877|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340878|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340879|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340880|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
359125|NCT00381303|O2|Outcome|Male|
340881|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340882|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340883|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340884|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340885|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340886|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340887|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340888|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340972|NCT00332488|P3|Participant Flow|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder administered prior to each meal (dose individualized for each subject) & Metformin (>= 1,000 mg/day or maximum tolerate dose)
342742|NCT00325234|B3|Baseline|Total|Total of all reporting groups
415208|NCT00525174|O2|Outcome|Patching|
340889|NCT00331864|E2|Reported Event|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340890|NCT00331864|E1|Reported Event|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
340891|NCT00332163|B3|Baseline|Total|Total of all reporting groups
340892|NCT00332163|B2|Baseline|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340893|NCT00332163|B1|Baseline|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340894|NCT00332163|P2|Participant Flow|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340895|NCT00332163|P1|Participant Flow|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340896|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340946|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
340947|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
340948|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
340897|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340898|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340899|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340900|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340901|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340902|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340903|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340904|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340905|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340906|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340907|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340908|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340909|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340910|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340911|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340912|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340913|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340914|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340949|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
340950|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
340951|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
340915|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340916|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340917|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340918|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340919|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340920|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340921|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340922|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340923|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340924|NCT00332163|E2|Reported Event|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
340925|NCT00332163|E1|Reported Event|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
340926|NCT00332189|B1|Baseline|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
340927|NCT00332189|P1|Participant Flow|Total Patient Population|Phenoptin will be taken orally once daily as the number of tablets equivalent to that of the last prescribed dose of the previous study (PKU-004 NCT00225615 or PKU-006 NCT00272792). Subjects who participated in PKU-006 NCT00272792 will receive Phenoptin as the number of tablets equivalent to 20 mg/kg/day at enrollment. The Phenoptin dose may be adjusted up or down as needed at the discretion of the investigator in increments of approximately 5 mg/kg/day within a range of 5 mg/kg/day to 20 mg/kg/day to control blood Phe to levels consistent with local clinical site recommendations for blood Phe control.
340928|NCT00332189|O1|Outcome|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
340929|NCT00332189|O1|Outcome|Total Patient Population|The safety analysis population includes all subjects who received at least one dose of study drug during the study.
340930|NCT00332189|E1|Reported Event|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
340931|NCT00332241|B3|Baseline|Total|Total of all reporting groups
340932|NCT00332241|B2|Baseline|Aripiprazole|oral aripiprazole 2 to 15 mg QD
340933|NCT00332241|B1|Baseline|Placebo|oral placebo once daily (QD)
340934|NCT00332241|P2|Participant Flow|Aripiprazole|oral aripiprazole 2 to 15 mg QD
340935|NCT00332241|P1|Participant Flow|Placebo|oral placebo once daily (QD)
340936|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
340937|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
340938|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
340939|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
340940|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
340941|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
340942|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
340943|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
340944|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
340945|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
359126|NCT00381303|O1|Outcome|Female|
340954|NCT00332332|B1|Baseline|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
340955|NCT00332332|P1|Participant Flow|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
340956|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
340957|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
340958|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
340959|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
340960|NCT00332332|E1|Reported Event|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
340961|NCT00332462|B1|Baseline|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
340962|NCT00332462|P1|Participant Flow|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
340963|NCT00332462|O2|Outcome|6 Months After Transplantation|
340964|NCT00332462|O1|Outcome|3 Months After Transplantation|
340965|NCT00332462|O1|Outcome|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
340966|NCT00332462|E2|Reported Event|Cyclosporine (Sandimmun® Optoral)|Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
340967|NCT00332462|E1|Reported Event|Cyclosporine (Sandimmun® i.v.)|Cyclosporine (Sandimmun®) intravenous (i.v) given 2 times daily as an infusion over a four hour period staring at a dose of 2 X 200 mg/day and continuing for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
340968|NCT00332488|B4|Baseline|Total|Total of all reporting groups
340969|NCT00332488|B3|Baseline|TI Inhalation Powder + Metformin|
340970|NCT00332488|B2|Baseline|Metformin & Secretagogues|
415209|NCT00525174|O1|Outcome|Bangerter|
340973|NCT00332488|P2|Participant Flow|Metformin & Secretagogues|Metformin (>= 1,000 mg/day or maximum tolerate dose) & Secretagogue (Sulfonylurea or meglitinide at >= half maximum manufacturer recommended dose or maximum tolerated dose)
340974|NCT00332488|P1|Participant Flow|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder administered prior to each meal without any other anti-diabetic treatment; dose individualized for each subject
340975|NCT00332488|O3|Outcome|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
340976|NCT00332488|O2|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
340977|NCT00332488|O1|Outcome|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
340978|NCT00332488|O2|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
340979|NCT00332488|O1|Outcome|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
340980|NCT00332488|O2|Outcome|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
340981|NCT00332488|O1|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
340982|NCT00332488|E3|Reported Event|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
340983|NCT00332488|E2|Reported Event|Metformin & Secretagogues|Metformin & Secretagogues
340984|NCT00332488|E1|Reported Event|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
340985|NCT00332579|B3|Baseline|Total|Total of all reporting groups
340986|NCT00332579|B2|Baseline|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
340987|NCT00332579|B1|Baseline|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
340988|NCT00332579|P2|Participant Flow|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
340989|NCT00332579|P1|Participant Flow|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
340990|NCT00332579|O2|Outcome|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
340991|NCT00332579|O1|Outcome|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
340992|NCT00332579|E2|Reported Event|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
340993|NCT00332579|E1|Reported Event|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
340994|NCT00332605|B4|Baseline|Total|Total of all reporting groups
340995|NCT00332605|B3|Baseline|Placebo|
340996|NCT00332605|B2|Baseline|N-Acetyl Cysteine|600mg tablets taken by mouth daily
359127|NCT00381303|O5|Outcome|Other|
340997|NCT00332605|B1|Baseline|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
340998|NCT00332605|P3|Participant Flow|Placebo|
340999|NCT00332605|P2|Participant Flow|N-Acetyl Cysteine|600mg tablets taken by mouth daily
341000|NCT00332605|P1|Participant Flow|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
341001|NCT00332605|O3|Outcome|Placebo|Placebo capsules
341002|NCT00332605|O2|Outcome|N-Acetyl Cysteine|600mg tablets, daily
341003|NCT00332605|O1|Outcome|Naltrexone|Naltrexone tablets
341004|NCT00332605|E3|Reported Event|Placebo|
341005|NCT00332605|E2|Reported Event|N-Acetyl Cysteine|600mg tablets taken by mouth daily
341006|NCT00332605|E1|Reported Event|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
341007|NCT00332644|B7|Baseline|Total|Total of all reporting groups
341008|NCT00332644|B6|Baseline|Placebo Control|placebo control (no active medication) treatment
341009|NCT00332644|B5|Baseline|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
341010|NCT00332644|B4|Baseline|Bupropion|bupropion alone treatment
341011|NCT00332644|B3|Baseline|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
341012|NCT00332644|B2|Baseline|Nicotine Lozenge|nicotine lozenge alone treatment
341013|NCT00332644|B1|Baseline|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
341014|NCT00332644|P6|Participant Flow|Placebo Control|placebo control (no active medication) treatment
341015|NCT00332644|P5|Participant Flow|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
341016|NCT00332644|P4|Participant Flow|Bupropion|bupropion alone treatment
341017|NCT00332644|P3|Participant Flow|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
341018|NCT00332644|P2|Participant Flow|Nicotine Lozenge|nicotine lozenge alone treatment
341019|NCT00332644|P1|Participant Flow|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
341020|NCT00332644|O6|Outcome|Placebo Control|placebo control (no active medication) treatment
341021|NCT00332644|O5|Outcome|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
341022|NCT00332644|O4|Outcome|Bupropion|bupropion alone treatment
341023|NCT00332644|O3|Outcome|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
341024|NCT00332644|O2|Outcome|Nicotine Lozenge|nicotine lozenge alone treatment
341025|NCT00332644|O1|Outcome|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
341026|NCT00332644|E6|Reported Event|Placebo Control|placebo control (no active medication) treatment
341027|NCT00332644|E5|Reported Event|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
341028|NCT00332644|E4|Reported Event|Bupropion|bupropion alone treatment
341029|NCT00332644|E3|Reported Event|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
341030|NCT00332644|E2|Reported Event|Nicotine Lozenge|nicotine lozenge alone treatment
341031|NCT00332644|E1|Reported Event|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
341032|NCT00332696|B3|Baseline|Total|Total of all reporting groups
341077|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
341078|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341033|NCT00332696|B2|Baseline|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341034|NCT00332696|B1|Baseline|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341035|NCT00332696|P2|Participant Flow|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341036|NCT00332696|P1|Participant Flow|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341037|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341038|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341039|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341406|NCT00321737|B4|Baseline|Total|Total of all reporting groups
341040|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341041|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341042|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341043|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341044|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341045|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341046|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341047|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341048|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341049|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341050|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341051|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341052|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341053|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341054|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341055|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341056|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341057|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341058|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341059|NCT00332696|E2|Reported Event|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341060|NCT00332696|E1|Reported Event|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
341061|NCT00332709|B3|Baseline|Total|Total of all reporting groups
341062|NCT00332709|B2|Baseline|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341063|NCT00332709|B1|Baseline|Letrozole|Letrozole 2.5 mg/day for 3 years
341064|NCT00332709|P2|Participant Flow|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341065|NCT00332709|P1|Participant Flow|Letrozole|Letrozole 2.5 mg/day for 3 years
341066|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341067|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
341068|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341069|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
341070|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341071|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
341072|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341073|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
341074|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341075|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
341076|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341082|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341083|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
341084|NCT00332709|E2|Reported Event|Letrozole + Zolendronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
341085|NCT00332709|E1|Reported Event|Letrozole|Letrozole orally 2.5 mg/day for 3 years
341086|NCT00332722|B3|Baseline|Total|Total of all reporting groups
341087|NCT00332722|B2|Baseline|Group 2 - With Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
341088|NCT00332722|B1|Baseline|Group 1- Without Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
341089|NCT00332722|P2|Participant Flow|Group 2 With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
341090|NCT00332722|P1|Participant Flow|Group 1 Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
341091|NCT00332722|O2|Outcome|Group 2 - With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
341092|NCT00332722|O1|Outcome|Group 1 - Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
341093|NCT00332722|O2|Outcome|Group 2 - With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
341094|NCT00332722|O1|Outcome|Group 1 - Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
341095|NCT00332722|E2|Reported Event|Group 2 - With Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
341096|NCT00332722|E1|Reported Event|Group 1- Without Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
341097|NCT00332839|B3|Baseline|Total|Total of all reporting groups
341098|NCT00332839|B2|Baseline|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
341099|NCT00332839|B1|Baseline|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
341100|NCT00332839|P2|Participant Flow|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
341101|NCT00332839|P1|Participant Flow|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
341102|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
341103|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
341104|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
341105|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
341106|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
341107|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
341108|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
341109|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
341110|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
341111|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
341112|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
341113|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
341114|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
341115|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
341116|NCT00332839|E2|Reported Event|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
341117|NCT00332839|E1|Reported Event|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
341118|NCT00316082|B6|Baseline|Total|Total of all reporting groups
341119|NCT00316082|B5|Baseline|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
341120|NCT00316082|B4|Baseline|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
341121|NCT00316082|B3|Baseline|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
341122|NCT00316082|B2|Baseline|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
341123|NCT00316082|B1|Baseline|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
341124|NCT00316082|P5|Participant Flow|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
341125|NCT00316082|P4|Participant Flow|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
341126|NCT00316082|P3|Participant Flow|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
341127|NCT00316082|P2|Participant Flow|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
341128|NCT00316082|P1|Participant Flow|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
341129|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
341130|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
341131|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
341132|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
341133|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
341134|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
341135|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
341136|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
341137|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
341138|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
341139|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
341140|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
341141|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
341142|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
341143|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
341144|NCT00316082|O2|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
341145|NCT00316082|O1|Outcome|Saxagliptin 5 mg QPM|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
341146|NCT00316082|O4|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
341147|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
341148|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
341149|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg QAM|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
341150|NCT00316082|E5|Reported Event|Saxagliptin 5 mg QPM|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
341151|NCT00316082|E4|Reported Event|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
341152|NCT00316082|E3|Reported Event|Saxagliptin 2.5 mg QAM|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
341874|NCT00322309|O1|Outcome|Mirtazepine|"Mirtazapine daily:
Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
341153|NCT00316082|E2|Reported Event|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
341154|NCT00316082|E1|Reported Event|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
341155|NCT00316121|B3|Baseline|Total|Total of all reporting groups
341156|NCT00316121|B2|Baseline|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
341157|NCT00316121|B1|Baseline|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.
The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
341158|NCT00316121|P2|Participant Flow|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
341159|NCT00316121|P1|Participant Flow|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.
The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
341183|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
359128|NCT00381303|O4|Outcome|Asian|
341160|NCT00316121|O2|Outcome|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
341161|NCT00316121|O1|Outcome|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.
The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
341162|NCT00316121|E2|Reported Event|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
341163|NCT00316121|E1|Reported Event|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.
The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
341164|NCT00316173|B3|Baseline|Total|Total of all reporting groups
341165|NCT00316173|B2|Baseline|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
341166|NCT00316173|B1|Baseline|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
341167|NCT00316173|P2|Participant Flow|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
341168|NCT00316173|P1|Participant Flow|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
341169|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
341170|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
341271|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
342965|NCT00325897|B1|Baseline|Azithromycin|Azithromycin, 250 mg
341171|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
341172|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
341173|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
341174|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
341175|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
341176|NCT00316173|E2|Reported Event|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
341177|NCT00316173|E1|Reported Event|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
341178|NCT00316186|B1|Baseline|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
341179|NCT00316186|P1|Participant Flow|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
341180|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
341181|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
341182|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
342072|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
341184|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
341185|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
341186|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
341187|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
341188|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
341189|NCT00316186|E1|Reported Event|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
341190|NCT00316199|B1|Baseline|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.
Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
341191|NCT00316199|P1|Participant Flow|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.
Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
341192|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.
Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
341193|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.
Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
341194|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.
Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
341195|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.
Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
341196|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.
Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
341197|NCT00316199|E1|Reported Event|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.
Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
341198|NCT00316225|B1|Baseline|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
341199|NCT00316225|P1|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
341200|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
341201|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
341202|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
341203|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
341204|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
341205|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
341206|NCT00316225|E1|Reported Event|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
341207|NCT00316264|B4|Baseline|Total|Total of all reporting groups
341208|NCT00316264|B3|Baseline|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
342966|NCT00325897|P2|Participant Flow|Placebo|Inactive sugar pill
341209|NCT00316264|B2|Baseline|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341210|NCT00316264|B1|Baseline|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341211|NCT00316264|P3|Participant Flow|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341212|NCT00316264|P2|Participant Flow|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341213|NCT00316264|P1|Participant Flow|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341214|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341215|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341216|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341217|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341218|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341219|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341220|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341407|NCT00321737|B3|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
341221|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341222|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341223|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341224|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341225|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341226|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341227|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341228|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341229|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341230|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341231|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341232|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341233|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341234|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341235|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341236|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341237|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341238|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341239|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341240|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341241|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341242|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341243|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341244|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341245|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341246|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341247|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341248|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341249|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341250|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341251|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
359129|NCT00381303|O3|Outcome|Hispanic|
341252|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341253|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341254|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341255|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341256|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341257|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341258|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341259|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341260|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341261|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341262|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341263|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341264|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341265|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341266|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341267|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341268|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341269|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341270|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
415210|NCT00525174|O2|Outcome|Patching|
341272|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341273|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341274|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341275|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341276|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341277|NCT00316264|E3|Reported Event|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341278|NCT00316264|E2|Reported Event|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
341279|NCT00316264|E1|Reported Event|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
341280|NCT00316277|B3|Baseline|Total|Total of all reporting groups
341281|NCT00316277|B2|Baseline|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
341282|NCT00316277|B1|Baseline|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
359130|NCT00381303|O2|Outcome|Caucasian|
341283|NCT00316277|P2|Participant Flow|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
341284|NCT00316277|P1|Participant Flow|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
341285|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
341286|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
341287|NCT00316277|O2|Outcome|Success in Phase 2 Among Participants Without Heroin Use|
341288|NCT00316277|O1|Outcome|Success in Phase 2 Among Participants With Heroin Use|
341289|NCT00316277|O2|Outcome|Success in Phase 1 Among Participants Without Heroin Use|
341290|NCT00316277|O1|Outcome|Success in Phase 1 Among Participants With Heroin Use|
341291|NCT00316277|O2|Outcome|Success in Phase 2 Among Participants Without Chronic Pain|
341292|NCT00316277|O1|Outcome|Success in Phase 2 Among Participants With Chronic Pain|"Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."
341293|NCT00316277|O2|Outcome|Success in Phase 1 Among Participants Without Chronic Pain|
341294|NCT00316277|O1|Outcome|Success in Phase 1 Among Participants With Chronic Pain|"Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."
341295|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
341296|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
341297|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
341298|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
341299|NCT00316277|E2|Reported Event|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
341300|NCT00316277|E1|Reported Event|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
341301|NCT00321646|B1|Baseline|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
341302|NCT00321646|P1|Participant Flow|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
341303|NCT00321646|O1|Outcome|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
341323|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341408|NCT00321737|B2|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
343621|NCT00334633|B4|Baseline|Total|Total of all reporting groups
341304|NCT00321646|O1|Outcome|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
341305|NCT00321646|E1|Reported Event|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy
Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
341306|NCT00321672|B5|Baseline|Total|Total of all reporting groups
341307|NCT00321672|B4|Baseline|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341308|NCT00321672|B3|Baseline|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
341309|NCT00321672|B2|Baseline|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341310|NCT00321672|B1|Baseline|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
341311|NCT00321672|P4|Participant Flow|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341312|NCT00321672|P3|Participant Flow|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
341313|NCT00321672|P2|Participant Flow|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341314|NCT00321672|P1|Participant Flow|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
341315|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341316|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
341875|NCT00322309|O2|Outcome|Placebo|Subjects received matched placebo capsules
341317|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341318|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
341319|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341320|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
341321|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341322|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
341324|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
341325|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341326|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
341327|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341328|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
341329|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341330|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
341331|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341332|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
341333|NCT00321672|E6|Reported Event|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341334|NCT00321672|E5|Reported Event|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
341335|NCT00321672|E4|Reported Event|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341336|NCT00321672|E3|Reported Event|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
341580|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
415211|NCT00525174|O1|Outcome|Bangerter|
341337|NCT00321672|E2|Reported Event|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
341338|NCT00321672|E1|Reported Event|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
341339|NCT00321685|B1|Baseline|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
341340|NCT00321685|P1|Participant Flow|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.
radiation therapy: Patients undergo 3-dimensional conformal radiation therapy once daily 5 days"
341341|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
341342|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
341343|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
341344|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
341345|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
341388|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341389|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341346|NCT00321685|E1|Reported Event|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
341347|NCT00321698|B6|Baseline|Total|Total of all reporting groups
341348|NCT00321698|B5|Baseline|Phase II, MTD Dose|"Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341349|NCT00321698|B4|Baseline|Phase I, Dose 3|"Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341350|NCT00321698|B3|Baseline|Phase I, Dose 2|"Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341351|NCT00321698|B2|Baseline|Phase I, Dose 1|"Drug: docetaxel
4 groups of men in phase I study.
Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341401|NCT00321711|E5|Reported Event|Part B Romiplostim 750 µg|
341402|NCT00321711|E4|Reported Event|Part B Placebo|
359131|NCT00381303|O1|Outcome|Black|
341352|NCT00321698|B1|Baseline|Phase I, Radiation Only|"Drug: N/A
4 groups of men in phase I study.
Group 1=radiation only
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341353|NCT00321698|P5|Participant Flow|Phase II, MTD Dose|"MTD=Docetaxel IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation plus external beam radiation, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341354|NCT00321698|P4|Participant Flow|Phase I, Dose 3|"Group 4=IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation;
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
341355|NCT00321698|P3|Participant Flow|Phase I, Dose 2|"Group 3=IV over 30mins, 20mg/m2 weekly x 5 weeks starting on day one of radiation;
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
341356|NCT00321698|P2|Participant Flow|Phase I, Dose 1|"Group 2=IV over 30mins, 10mg/m2 weekly x 5 weeks starting on day one of radiation;
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
341357|NCT00321698|P1|Participant Flow|Phase I, Radiation Only|"Group 1=radiation only;
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341358|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.
Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
341359|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.
Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
341360|NCT00321698|O2|Outcome|Phase II MTD Dose|"Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341361|NCT00321698|O1|Outcome|Phase I Dose 1-4|"Group 1=radiation only; Group 2=Docetaxel IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=Docetaxel IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341390|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341391|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341362|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.
Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
341363|NCT00321698|O1|Outcome|Phase II MTD Dose|"Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341364|NCT00321698|O1|Outcome|Phase I Dose 1-4|"4 groups of men in phase I study.
Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation."
341365|NCT00321698|E5|Reported Event|Phase II, MTD Dose|"Drug: docetaxel
Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341366|NCT00321698|E4|Reported Event|Phase I, Dose 3|"Drug: docetaxel
4 groups of men in phase I study.
Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341403|NCT00321711|E3|Reported Event|Part A Romiplostim 750 µg|
341404|NCT00321711|E2|Reported Event|Part A Romiplostim 500 µg|
341405|NCT00321711|E1|Reported Event|Part A Placebo|
341367|NCT00321698|E3|Reported Event|Phase I, Dose 2|"Drug: docetaxel
4 groups of men in phase I study.
Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341368|NCT00321698|E2|Reported Event|Phase I, Dose 1|"Drug: docetaxel
4 groups of men in phase I study.
Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341369|NCT00321698|E1|Reported Event|Phase I, Radiation Only|"Drug: N/A
4 groups of men in phase I study.
Group 1=radiation only
Radiation: radiation therapy
All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
341370|NCT00321711|B6|Baseline|Total|Total of all reporting groups
341371|NCT00321711|B5|Baseline|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341372|NCT00321711|B4|Baseline|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341373|NCT00321711|B3|Baseline|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341374|NCT00321711|B2|Baseline|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341375|NCT00321711|B1|Baseline|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341376|NCT00321711|P5|Participant Flow|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341377|NCT00321711|P4|Participant Flow|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341378|NCT00321711|P3|Participant Flow|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341379|NCT00321711|P2|Participant Flow|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341380|NCT00321711|P1|Participant Flow|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341381|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341382|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341383|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341384|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341385|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341386|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341387|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341575|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341392|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341393|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341394|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341395|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341396|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341397|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
341398|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341399|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341400|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
341409|NCT00321737|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
341410|NCT00321737|P3|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
341411|NCT00321737|P2|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
341412|NCT00321737|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
341413|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
341414|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
341415|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
341416|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
341417|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
341418|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
341419|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
341420|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
341421|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
341422|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
341423|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
341424|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
341425|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
341426|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
341427|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
341428|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
341429|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
341430|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
341431|NCT00321737|E3|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
341432|NCT00321737|E2|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
341433|NCT00321737|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
341434|NCT00321763|B5|Baseline|Total|Total of all reporting groups
341435|NCT00321763|B4|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341436|NCT00321763|B3|Baseline|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341437|NCT00321763|B2|Baseline|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341581|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341438|NCT00321763|B1|Baseline|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341439|NCT00321763|P4|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341440|NCT00321763|P3|Participant Flow|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341441|NCT00321763|P2|Participant Flow|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341442|NCT00321763|P1|Participant Flow|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341443|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341444|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341445|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341446|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341447|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341448|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341449|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341450|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341451|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341452|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341453|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341454|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341455|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341456|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341457|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341458|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341459|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341460|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341461|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341462|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341576|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
342967|NCT00325897|P1|Participant Flow|Azithromycin|Azithromycin, 250 mg
341463|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341464|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341465|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341466|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341467|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341468|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341469|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341470|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341471|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341472|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341473|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341474|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341475|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341476|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341477|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341478|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341479|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341480|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341481|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341482|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341483|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341484|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341485|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341486|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341487|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341488|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341489|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341490|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341491|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341492|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341493|NCT00321763|E5|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341494|NCT00321763|E4|Reported Event|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
341495|NCT00321763|E3|Reported Event|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341496|NCT00321763|E2|Reported Event|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341497|NCT00321763|E1|Reported Event|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
341498|NCT00321789|B3|Baseline|Total|Total of all reporting groups
341599|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341499|NCT00321789|B2|Baseline|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341500|NCT00321789|B1|Baseline|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341501|NCT00321789|P2|Participant Flow|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341502|NCT00321789|P1|Participant Flow|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341503|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341504|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341505|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341506|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341507|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341508|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341509|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341510|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341511|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341577|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341635|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341512|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341513|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341514|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341515|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341516|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341517|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341518|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
343784|NCT00335452|B5|Baseline|Total|Total of all reporting groups
341519|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341520|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341521|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341522|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341523|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341524|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341525|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341526|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341527|NCT00321789|E2|Reported Event|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
341528|NCT00321789|E1|Reported Event|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
341529|NCT00321828|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
341530|NCT00321828|P1|Participant Flow|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
341531|NCT00321828|O1|Outcome|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
341532|NCT00321828|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
341533|NCT00321854|B3|Baseline|Total|Total of all reporting groups
341534|NCT00321854|B2|Baseline|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341535|NCT00321854|B1|Baseline|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341578|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
343767|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
341536|NCT00321854|P2|Participant Flow|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
341537|NCT00321854|P1|Participant Flow|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
341538|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
341539|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
341540|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
341541|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
341542|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
341600|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
343785|NCT00335452|B4|Baseline|Clopidogrel 600/150/75 mg + ASA High Dose|
341543|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
341544|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
341545|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
341546|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341547|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341548|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341549|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341550|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341551|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341552|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341553|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341554|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341555|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341556|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341557|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341558|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341559|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341560|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341561|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341562|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341563|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341564|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341565|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341566|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341567|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341568|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341569|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341570|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341571|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341572|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341573|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341574|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341582|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341583|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341584|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341585|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341586|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341587|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341588|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341589|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341590|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341591|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341592|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341593|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341594|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341595|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341596|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341597|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341598|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341601|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341602|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341603|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341604|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341605|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341606|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341607|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341608|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341609|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341610|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341611|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341612|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341613|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341614|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341615|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341616|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341617|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341618|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341619|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341620|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341621|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341622|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341623|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341624|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341625|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341626|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341627|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341628|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341629|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341630|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341631|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341632|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341633|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341634|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
415212|NCT00525174|O2|Outcome|Patching|
341636|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341637|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341638|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341639|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341640|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341641|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341642|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341643|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341644|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341645|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341646|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341647|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341648|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341649|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341650|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341651|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341652|NCT00321854|E2|Reported Event|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
341653|NCT00321854|E1|Reported Event|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
341654|NCT00321893|B3|Baseline|Total|Total of all reporting groups
359132|NCT00381303|O7|Outcome|Other|
341655|NCT00321893|B2|Baseline|Arm II: Placebo|Inhaled placebo twice daily for 1 year
341656|NCT00321893|B1|Baseline|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
341657|NCT00321893|P2|Participant Flow|Arm II: Placebo|Inhaled placebo twice daily for 1 year
341658|NCT00321893|P1|Participant Flow|Arm I: Budesonide|Inhaled Budesonide 800 micrograms (ug) twice daily for 1 year
341659|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
341660|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
341661|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
341662|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
341663|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
341664|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
341665|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
341666|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
341667|NCT00321893|E2|Reported Event|Arm II: Placebo|Inhaled placebo twice daily for 1 year
341668|NCT00321893|E1|Reported Event|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
341669|NCT00321906|B3|Baseline|Total|Total of all reporting groups
341670|NCT00321906|B2|Baseline|Sirolimus|tacrolimus/sirolimus/prednisone
341671|NCT00321906|B1|Baseline|Azathioprine|(tacrolimus,azathioprine/prednisone)
341672|NCT00321906|P2|Participant Flow|Sirolimus|tacrolimus/sirolimus/prednisone
341673|NCT00321906|P1|Participant Flow|Azathioprine|(tacrolimus,azathioprine/prednisone)
341674|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
341675|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
341676|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
341677|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
341678|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
341679|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
341680|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
341681|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
341682|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
341683|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
341684|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
341685|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
341686|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
341687|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
341688|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
341689|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
341690|NCT00321906|E2|Reported Event|Sirolimus|tacrolimus/sirolimus/prednisone
341691|NCT00321906|E1|Reported Event|Azathioprine|(tacrolimus,azathioprine/prednisone)
341692|NCT00321919|B3|Baseline|Total|Total of all reporting groups
341693|NCT00321919|B2|Baseline|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341694|NCT00321919|B1|Baseline|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341695|NCT00321919|P2|Participant Flow|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL has occurred in order to reach a target Hb of 10.5-11.5 g/dL.
342968|NCT00325897|O2|Outcome|Placebo|"Inactive
Placebo: Placebo taken on a daily basis"
341696|NCT00321919|P1|Participant Flow|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hemoglobin (Hb) level of 13-15 gram/decilitre (g/dL) with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341697|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341698|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341699|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341700|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341701|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341702|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341703|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341761|NCT00321984|B3|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
343786|NCT00335452|B3|Baseline|Clopidogrel 600/150/75 mg + ASA Low Dose|
341704|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341705|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341706|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341707|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341708|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341709|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341710|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341711|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341712|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341713|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341714|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341715|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341716|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months
341717|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341718|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341719|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341720|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
343768|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
341721|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341722|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341723|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341724|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341725|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341726|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341727|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341728|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341729|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341730|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341731|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341732|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341733|NCT00321919|E2|Reported Event|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
341734|NCT00321919|E1|Reported Event|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
341735|NCT00321932|B3|Baseline|Total|Total of all reporting groups
341736|NCT00321932|B2|Baseline|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341737|NCT00321932|B1|Baseline|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
341738|NCT00321932|P2|Participant Flow|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341739|NCT00321932|P1|Participant Flow|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
341740|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341741|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
341742|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341743|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
341744|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341745|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
341746|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341747|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
341748|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341749|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
344402|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
341750|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341751|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
341752|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341753|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
341754|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV)( over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341755|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
341756|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341757|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
341758|NCT00321932|E2|Reported Event|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
341759|NCT00321932|E1|Reported Event|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
341760|NCT00321984|B4|Baseline|Total|Total of all reporting groups
341762|NCT00321984|B2|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
341763|NCT00321984|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
341764|NCT00321984|P3|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
341765|NCT00321984|P2|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
341766|NCT00321984|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
341767|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
341768|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
341769|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
341770|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
341771|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
341772|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
341773|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
341774|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
341775|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
341776|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
341777|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
341778|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
341779|NCT00321984|E3|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
341780|NCT00321984|E2|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
341781|NCT00321984|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
341782|NCT00322049|B5|Baseline|Total|Total of all reporting groups
341783|NCT00322049|B4|Baseline|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
341784|NCT00322049|B3|Baseline|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341785|NCT00322049|B2|Baseline|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341786|NCT00322049|B1|Baseline|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341787|NCT00322049|P4|Participant Flow|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
341788|NCT00322049|P3|Participant Flow|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341789|NCT00322049|P2|Participant Flow|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341790|NCT00322049|P1|Participant Flow|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341791|NCT00322049|O2|Outcome|Nested PCR|Scheduled phlebotomy and unscheduled phlebotomy when a subject was ill during the study revealed dengue viremia
341792|NCT00322049|O1|Outcome|RT-PCR|Scheduled phlebotomy and unscheduled phlebotomy when a subject was ill during the study revealed dengue viremia
341793|NCT00322049|O5|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full dose dengue vaccine at study months 0 and 6
341794|NCT00322049|O4|Outcome|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341795|NCT00322049|O3|Outcome|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341796|NCT00322049|O2|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341797|NCT00322049|O1|Outcome|Control Group|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
341798|NCT00322049|O3|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341799|NCT00322049|O2|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341800|NCT00322049|O1|Outcome|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
341801|NCT00322049|O4|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full dose dengue vaccine at study months 0 and 6
341802|NCT00322049|O3|Outcome|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341803|NCT00322049|O2|Outcome|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341804|NCT00322049|O1|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341805|NCT00322049|O4|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full dose dengue vaccine at study months 0 and 6
341806|NCT00322049|O3|Outcome|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341807|NCT00322049|O2|Outcome|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341808|NCT00322049|O1|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341809|NCT00322049|O3|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341810|NCT00322049|O2|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341811|NCT00322049|O1|Outcome|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
341812|NCT00322049|O3|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341813|NCT00322049|O2|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
341814|NCT00322049|O1|Outcome|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
341815|NCT00322049|E4|Reported Event|Control Group|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
341816|NCT00322049|E3|Reported Event|Cohort C: Dengue Vaccine - Full Dose (T-DEN F17 )|Dengue vaccine at Months 0 and 6 and booster follow-up at 3 years
341817|NCT00322049|E2|Reported Event|Cohort B: Full Dose (T-DEN F17 )|Control vaccines: Hemophilus influenza type b (Hib) vaccine and varicella vaccine
341818|NCT00322049|E1|Reported Event|Cohort A: Dengue Vaccine- 1/10 Dose (T-DEN F17 )|Dengue vaccine at Months 0 and 6 and booster follow-up at 3 years;
341819|NCT00322101|B3|Baseline|Total|Total of all reporting groups
341820|NCT00322101|B2|Baseline|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
341821|NCT00322101|B1|Baseline|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
341822|NCT00322101|P2|Participant Flow|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
341823|NCT00322101|P1|Participant Flow|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
343074|NCT00326196|O2|Outcome|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
341824|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
341825|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
341826|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
341827|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
341828|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
341829|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
341830|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
341831|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
341832|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
341833|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
341834|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
341870|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:
Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
341871|NCT00322309|O2|Outcome|Placebo|Matched placebo given daily days 1-84
341872|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:
Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
341873|NCT00322309|O2|Outcome|Placebo|Matched placebo capsules
415213|NCT00525174|O1|Outcome|Bangerter|
341835|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
341836|NCT00322101|E2|Reported Event|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.
Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.
Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.
TRANSPLANTATION: Patients undergo PBSC infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
341837|NCT00322101|E1|Reported Event|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
341838|NCT00322153|B3|Baseline|Total|Total of all reporting groups
341839|NCT00322153|B2|Baseline|Memantine ER|28mg once daily oral administration for 24 weeks.
341840|NCT00322153|B1|Baseline|Placebo|Matching placebo oral administration once daily for 24 weeks.
341841|NCT00322153|P2|Participant Flow|Memantine ER|28mg once daily oral administration for 24 weeks.
341842|NCT00322153|P1|Participant Flow|Placebo|Matching placebo oral administration once daily for 24 weeks.
359133|NCT00381303|O6|Outcome|Asian|
341843|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
341844|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
341845|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
341846|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
341847|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
341848|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
341849|NCT00322153|E2|Reported Event|Memantine ER|28mg once daily oral administration for 24 weeks.
341850|NCT00322153|E1|Reported Event|Placebo|Matching placebo oral administration once daily for 24 weeks.
341851|NCT00322231|B3|Baseline|Total|Total of all reporting groups
341852|NCT00322231|B2|Baseline|Placebo / ZOSTAVAX™|0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
341853|NCT00322231|B1|Baseline|ZOSTAVAX™ / Placebo|0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
341854|NCT00322231|P2|Participant Flow|Placebo / ZOSTAVAX™|0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
341855|NCT00322231|P1|Participant Flow|ZOSTAVAX™ / Placebo|0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
341856|NCT00322231|O2|Outcome|Placebo|Participants included in this analysis were those who received Placebo in Placebo /ZOSTAVAX™ group (on Day 1). Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group were excluded in order to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
341857|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group are included. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
341858|NCT00322231|O2|Outcome|Placebo|Participants who received placebo (at Day 1) in Placebo / ZOSTAVAX™ group. Participants who received ZOSTAVAX™ at (Day 1) in the ZOSTAVAX™ / Placebo group were excluded to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements.
341859|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included.
341860|NCT00322231|O2|Outcome|Placebo|Participants who received placebo in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ Group (see participant flow section) are included.
341861|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included
341862|NCT00322231|E2|Reported Event|Placebo|All participants that received Placebo in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™. Five participants that received placebo were lost to follow up and not included in the analysis.
341863|NCT00322231|E1|Reported Event|ZOSTAVAX™|All participants that received ZOSTAVAX™ from both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group. Two participants that received ZOSTAVAX™ were lost to follow up and not included in the analysis.
341864|NCT00322309|B3|Baseline|Total|Total of all reporting groups
341865|NCT00322309|B2|Baseline|Placebo|Subjects received matched placebo capsules
341866|NCT00322309|B1|Baseline|Mirtazapine|"Mirtazapine daily:
Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
341867|NCT00322309|P2|Participant Flow|Placebo|Matched placebo given daily days 1-84
341868|NCT00322309|P1|Participant Flow|Mirtazapine|"Mirtazapine daily:
Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
341869|NCT00322309|O2|Outcome|Placebo|Matched placebo given daily days 1-84
415214|NCT00525174|O2|Outcome|Patching|
341876|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:
Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
341877|NCT00322309|O2|Outcome|Placebo|Subjects received matched placebo capsules
341878|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:
Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
341879|NCT00322309|E2|Reported Event|Placebo|Matched placebo
341880|NCT00322309|E1|Reported Event|Mirtazapine Daily: Days 1-4 15mg Days 5-9 30mg Mirtazapine|"Mirtazapine daily:
Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
341881|NCT00322335|B4|Baseline|Total|Total of all reporting groups
341882|NCT00322335|B3|Baseline|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341883|NCT00322335|B2|Baseline|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341957|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
343787|NCT00335452|B2|Baseline|Clopidogrel 300/75/75 mg + ASA High Dose|
341884|NCT00322335|B1|Baseline|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341885|NCT00322335|P3|Participant Flow|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341886|NCT00322335|P2|Participant Flow|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341887|NCT00322335|P1|Participant Flow|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341888|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341889|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341890|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341891|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341941|NCT00322348|E2|Reported Event|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
341942|NCT00322348|E1|Reported Event|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
341943|NCT00322374|B4|Baseline|Total|Total of all reporting groups
341944|NCT00322374|B3|Baseline|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
342498|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
341892|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341893|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341894|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341958|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
343788|NCT00335452|B1|Baseline|Clopidogrel 300/75/75 mg + ASA Low Dose|
341895|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341896|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341897|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341898|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341899|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341900|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341901|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341902|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341903|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341945|NCT00322374|B2|Baseline|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341904|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341905|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341906|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341907|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341908|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341909|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341910|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341911|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341912|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341913|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341914|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341915|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341946|NCT00322374|B1|Baseline|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341916|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341917|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341918|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341919|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341920|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341921|NCT00322335|E3|Reported Event|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
341922|NCT00322335|E2|Reported Event|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341923|NCT00322335|E1|Reported Event|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
341924|NCT00322348|B3|Baseline|Total|Total of all reporting groups
341925|NCT00322348|B2|Baseline|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
341926|NCT00322348|B1|Baseline|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
341927|NCT00322348|P2|Participant Flow|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
341928|NCT00322348|P1|Participant Flow|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
341929|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
341930|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
341931|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
341932|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
341933|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
341934|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
341935|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
341936|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
341937|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
341938|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
341939|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
341940|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
341947|NCT00322374|P4|Participant Flow|All Participants|
341948|NCT00322374|P3|Participant Flow|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341949|NCT00322374|P2|Participant Flow|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341950|NCT00322374|P1|Participant Flow|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341951|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with a best response of either CR or PR.
341952|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants with measurable disease and with a best tumor response of either CR or PR.
341953|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with a best response of either CR or PR.
341954|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants with measurable disease and with a best tumor response of either CR or PR.
341955|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with measurable disease at baseline per RECIST
341956|NCT00322374|O1|Outcome|All Participants With Measurable Disease|Participants with measurable disease at baseline per RECIST
342068|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
341959|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341960|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341961|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341962|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341963|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341964|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341965|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341966|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341967|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341968|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341969|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341970|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341971|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341972|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341973|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341974|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341975|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341976|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341977|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341978|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341979|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341980|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341981|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341982|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341983|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341984|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341985|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341986|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341987|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341988|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341989|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341990|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants received Ixabepilone administered as a 3-hour IV infusion following a 3- to 5-minute IV infusion of Epirubicin every 21 days.
359134|NCT00381303|O5|Outcome|Hispanic|
341991|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341992|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341993|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341994|NCT00322374|E3|Reported Event|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341995|NCT00322374|E2|Reported Event|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341996|NCT00322374|E1|Reported Event|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
341997|NCT00322387|B3|Baseline|Total|Total of all reporting groups
341998|NCT00322387|B2|Baseline|Multiple Myeloma (MM)|Participants with multiple myeloma were assigned to any of the 4 treatment arms.
341999|NCT00322387|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.
342000|NCT00322387|P2|Participant Flow|Multiple Myeloma (MM)|Participants with multiple myeloma were assigned to any of the 4 treatment arms.
342001|NCT00322387|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.
342002|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.
Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
342003|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
342004|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
342005|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
342030|NCT00322387|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
415215|NCT00525174|O1|Outcome|Bangerter|
342006|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.
Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
342007|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
342008|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
342197|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
359135|NCT00381303|O4|Outcome|Caucasian|
342009|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.
Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
342010|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
342011|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
342012|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
342013|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.
Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
342014|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
342015|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
342016|NCT00322387|O8|Outcome|All Participants|
342017|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.
Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
342055|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342056|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
343075|NCT00326196|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous coronary intervention
342018|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
342019|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
342020|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
345048|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
342021|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.
Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
342022|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
342023|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
342024|NCT00322387|E7|Reported Event|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen.
Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
342025|NCT00322387|E6|Reported Event|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|"Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen.
Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was adminstered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days."
342026|NCT00322387|E5|Reported Event|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
342027|NCT00322387|E4|Reported Event|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
342028|NCT00322387|E3|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen.
Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
342029|NCT00322387|E2|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
342031|NCT00322439|B1|Baseline|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342032|NCT00322439|P1|Participant Flow|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342033|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342069|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342070|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342071|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
359136|NCT00381303|O3|Outcome|Black|
342034|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342035|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342036|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342037|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342038|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342039|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342040|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342041|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342042|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342043|NCT00322439|E1|Reported Event|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
342044|NCT00322452|B3|Baseline|Total|Total of all reporting groups
342045|NCT00322452|B2|Baseline|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342046|NCT00322452|B1|Baseline|Gefitinib|Gefitinib 250mg daily
342047|NCT00322452|P2|Participant Flow|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342048|NCT00322452|P1|Participant Flow|Gefitinib|Gefitinib 250mg daily
342049|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342050|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342051|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342052|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342053|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342054|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
347074|NCT00349908|O1|Outcome|Group 1|Atherosclerosis Arm
342057|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342058|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342059|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342060|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342061|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342062|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342063|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342064|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342065|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342066|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342067|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
359137|NCT00381303|O2|Outcome|Male|
342073|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342074|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342075|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342076|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342077|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342078|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342079|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342080|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
342081|NCT00322452|E2|Reported Event|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
342082|NCT00322452|E1|Reported Event|Gefitinib|Gefitinib 250mg daily
342083|NCT00322465|B5|Baseline|Total|Total of all reporting groups
342084|NCT00322465|B4|Baseline|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342085|NCT00322465|B3|Baseline|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342086|NCT00322465|B2|Baseline|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342087|NCT00322465|B1|Baseline|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342088|NCT00322465|P4|Participant Flow|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342089|NCT00322465|P3|Participant Flow|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342090|NCT00322465|P2|Participant Flow|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342091|NCT00322465|P1|Participant Flow|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342092|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342093|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342094|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342095|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342096|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342097|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342098|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342099|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342100|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342101|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342102|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342103|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342104|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342105|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342106|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342107|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342108|NCT00322465|O1|Outcome|All Participants Analyzed|
342109|NCT00322465|O1|Outcome|All Participants Analyzed|
342110|NCT00322465|O1|Outcome|All Participants Analyzed|
342111|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342112|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342198|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
342199|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
342113|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342114|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342115|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342116|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342117|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342118|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342119|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342120|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342121|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342122|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342123|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342124|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342125|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342126|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342127|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342128|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342129|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342130|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342131|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342132|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342133|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342134|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342135|NCT00322465|O2|Outcome|Azithromycin + (Azithromycin + Tinidazole)|Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
342136|NCT00322465|O1|Outcome|Doxycycline + (Doxycycline + Tinidazole)|Doxycycline 100 mg PO BID (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin PO single dose and placebo tinidazole + (Doxycycline 100 mg PO BID for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm PO single dose (4 tablets at 500 mg each)).
342499|NCT00323609|E2|Reported Event|Vertebroplasty|This group of patients has received vertebroplasty procedure.
347395|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
342137|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342138|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342139|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342140|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342141|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342142|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342143|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342144|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342145|NCT00322465|E4|Reported Event|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
342146|NCT00322465|E3|Reported Event|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
342147|NCT00322465|E2|Reported Event|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
342148|NCT00322465|E1|Reported Event|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
342149|NCT00322491|B3|Baseline|Total|Total of all reporting groups
342150|NCT00322491|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342151|NCT00322491|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342152|NCT00322491|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342153|NCT00322491|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342154|NCT00322491|O3|Outcome|All Participants|
342155|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342156|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342157|NCT00322491|O3|Outcome|All Participants|
342158|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342159|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342160|NCT00322491|O3|Outcome|All Participants|
342161|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342162|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342163|NCT00322491|O3|Outcome|All Participants|
342164|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342165|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342166|NCT00322491|O3|Outcome|All Participants|
342167|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342200|NCT00322621|O4|Outcome|Rescue Arm|duloxetine 120 mg once daily
342201|NCT00322621|O3|Outcome|Maintenance Arm (Later Dose Increase)|duloxetine 60 mg once daily and then increasing to 120 mg once daily
342202|NCT00322621|O2|Outcome|Maintenance Arm (No Dose Increase)|duloxetine 60 mg once daily
342168|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342169|NCT00322491|O3|Outcome|All Participants|
342170|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342171|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342172|NCT00322491|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342173|NCT00322491|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342174|NCT00322556|B1|Baseline|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
342175|NCT00322556|P1|Participant Flow|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
342176|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
342177|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
342178|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
342179|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
342180|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
342181|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
342182|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
342183|NCT00322556|O3|Outcome|IgPro10 (> 8 to ≤ 12 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (> 8 and ≤ 12 mg/kg/min) for old subjects.
342184|NCT00322556|O2|Outcome|IgPro10 (≤ 8 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.
342185|NCT00322556|O1|Outcome|IgPro10 (≤ 4 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the maximum infusion rate (≤ 4 mg/kg/min) for new subjects.
342186|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
342187|NCT00322556|E1|Reported Event|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
415216|NCT00525174|O2|Outcome|Patching|
342188|NCT00322621|B1|Baseline|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
342189|NCT00322621|P3|Participant Flow|Rescue Arm|Duloxetine: 120 milligrams once daily.
342190|NCT00322621|P2|Participant Flow|Maintenance Arm|Duloxetine: 60 milligrams once daily.
342191|NCT00322621|P1|Participant Flow|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months.
342192|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
342193|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
342194|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
342195|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
342196|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
342203|NCT00322621|O1|Outcome|All Maintenance / Rescue Participants|Total of the Maintenance (No Dose Increase), Maintenance (Later Dose Increase) and Rescue arms. Depending on the group the patient was in, they either received duloxetine 60 mg once daily; 60 mg once daily and then increased to 120 mg once daily; or 120 mg once daily.
342204|NCT00322621|O1|Outcome|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
342205|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342206|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342207|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342208|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342209|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342210|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342211|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342212|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342213|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342214|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342215|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342216|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342217|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342218|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342219|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342220|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342221|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342222|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342223|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342224|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342225|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342226|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342227|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342228|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342229|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342230|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342231|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342232|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342233|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342234|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342235|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342236|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342237|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
342238|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342239|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
342240|NCT00322621|E2|Reported Event|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
342241|NCT00322621|E1|Reported Event|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
342242|NCT00322712|B1|Baseline|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
342243|NCT00322712|P1|Participant Flow|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
342244|NCT00322712|O1|Outcome|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
342500|NCT00323609|E1|Reported Event|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342245|NCT00322712|E1|Reported Event|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
342246|NCT00322777|B3|Baseline|Total|Total of all reporting groups
342247|NCT00322777|B2|Baseline|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
342248|NCT00322777|B1|Baseline|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
342249|NCT00322777|P2|Participant Flow|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
342250|NCT00322777|P1|Participant Flow|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
342251|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
342401|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
342252|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
342253|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
342254|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
342255|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
342256|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
342257|NCT00322777|E2|Reported Event|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
342258|NCT00322777|E1|Reported Event|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
342259|NCT00322842|B3|Baseline|Total|Total of all reporting groups
342260|NCT00322842|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342261|NCT00322842|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342262|NCT00322842|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342263|NCT00322842|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342264|NCT00322842|O3|Outcome|All Participants|
342265|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342266|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342267|NCT00322842|O3|Outcome|All Participants|
342268|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342501|NCT00323622|B9|Baseline|Total|Total of all reporting groups
343076|NCT00326196|E2|Reported Event|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
342269|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342270|NCT00322842|O3|Outcome|All Participants|
342271|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342272|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342273|NCT00322842|O3|Outcome|All Participants|
342274|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342275|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342276|NCT00322842|O3|Outcome|All Participants|
342277|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342278|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342279|NCT00322842|O3|Outcome|All Participants|
342280|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342281|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342282|NCT00322842|O3|Outcome|All Participants|
342283|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342284|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342285|NCT00322842|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342286|NCT00322842|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
342287|NCT00322855|B1|Baseline|Chart Review|patients diagnosed with soft tissue sarcoma
342288|NCT00322855|P1|Participant Flow|Chart Review|patients diagnosed with soft tissue sarcoma
342289|NCT00322855|O1|Outcome|Chart Review|patients diagnosed with soft tissue sarcoma
342290|NCT00322855|E1|Reported Event|Chart Review|patients diagnosed with soft tissue sarcoma
342291|NCT00322881|B1|Baseline|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
342292|NCT00322881|P1|Participant Flow|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
342672|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342293|NCT00322881|O1|Outcome|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
342294|NCT00322881|E1|Reported Event|Carboplatin/Paclitaxel|"Paclitaxel: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)
Carboplatin: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)"
342295|NCT00323037|B3|Baseline|Total|Total of all reporting groups
342296|NCT00323037|B2|Baseline|Coreg Controlled Release|
342297|NCT00323037|B1|Baseline|Coreg Immediate Release|
342298|NCT00323037|P2|Participant Flow|Coreg Controlled Release|
342299|NCT00323037|P1|Participant Flow|Coreg Immediate Release|
342300|NCT00323037|O2|Outcome|Coreg Controlled Release|
342301|NCT00323037|O1|Outcome|Coreg Immediate Release|
342302|NCT00323115|B1|Baseline|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
342303|NCT00323115|P1|Participant Flow|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
342304|NCT00323115|O1|Outcome|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
342305|NCT00323115|O1|Outcome|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
342306|NCT00323115|E1|Reported Event|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
342307|NCT00323193|B3|Baseline|Total|Total of all reporting groups
342308|NCT00323193|B2|Baseline|Control Group|The control condition offers basic information about diet and exercise on a monthly basis.
342309|NCT00323193|B1|Baseline|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.
MOVE!: group based psychoeducation, motivation and support"
342310|NCT00323193|P2|Participant Flow|Control Group|The control group offers basic information about diet and exercise every month for six months.
342311|NCT00323193|P1|Participant Flow|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.
MOVE!: group based psychoeducation, motivation and support"
342312|NCT00323193|O2|Outcome|Control Group|The control group offers basic information about diet and exercise every month for six months.
342313|NCT00323193|O1|Outcome|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.
MOVE!: group based psychoeducation, motivation and support"
342314|NCT00323193|O2|Outcome|Control Group|The control group offers basic information about diet and exercise every month for six months.
342315|NCT00323193|O1|Outcome|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.
MOVE!: group based psychoeducation, motivation and support"
342316|NCT00323193|E2|Reported Event|Control Group|The control condition offers basic information about diet and exercise on a monthly basis.
342317|NCT00323193|E1|Reported Event|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.
MOVE!: group based psychoeducation, motivation and support"
342318|NCT00323258|B3|Baseline|Total|Total of all reporting groups
342319|NCT00323258|B2|Baseline|Usual Care|"The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
342320|NCT00323258|B1|Baseline|Intervention Arm|"Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
342361|NCT00323297|P1|Participant Flow|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
348131|NCT00351819|B3|Baseline|Total|Total of all reporting groups
342321|NCT00323258|P2|Participant Flow|Usual Care|"The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
342322|NCT00323258|P1|Participant Flow|Intervention Arm|"Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
342399|NCT00323427|P1|Participant Flow|Group Aural Rehabilitation|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
342400|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
342323|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
342324|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
342325|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
342326|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
342327|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
342328|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
342329|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
342330|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
342331|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
342332|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
342333|NCT00323258|E2|Reported Event|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
342334|NCT00323258|E1|Reported Event|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
342335|NCT00323271|B3|Baseline|Total|Total of all reporting groups
342336|NCT00323271|B2|Baseline|Educational Intervention|"Interventional: Educational intervention
Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
342391|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
348239|NCT00352612|E2|Reported Event|Clindamycin|
342337|NCT00323271|B1|Baseline|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy
Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
342338|NCT00323271|P2|Participant Flow|Educational Intervention|"Interventional: Educational intervention
Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
342365|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
342941|NCT00325819|B2|Baseline|Placebo|Subjects who were randomized to receive placebo
342339|NCT00323271|P1|Participant Flow|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy
Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
342340|NCT00323271|O2|Outcome|Educational Intervention|"Interventional: Educational intervention
Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
342341|NCT00323271|O1|Outcome|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy
Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
342342|NCT00323271|O2|Outcome|Educational Intervention|"Interventional: Educational intervention
Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
342343|NCT00323271|O1|Outcome|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy
Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
342344|NCT00323271|E2|Reported Event|Educational Intervention|"Interventional: Educational intervention
Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
342345|NCT00323271|E1|Reported Event|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy
Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
342346|NCT00323284|B3|Baseline|Total|Total of all reporting groups
342347|NCT00323284|B2|Baseline|B--Cataract Surgery Only|Cataract Surgery only
342348|NCT00323284|B1|Baseline|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
342349|NCT00323284|P2|Participant Flow|B--Cataract Surgery Only|Cataract Surgery only
342350|NCT00323284|P1|Participant Flow|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
342351|NCT00323284|O2|Outcome|B--Cataract Surgery Only|Cataract Surgery only
342352|NCT00323284|O1|Outcome|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
342353|NCT00323284|O2|Outcome|B--Cataract Surgery Only|Cataract Surgery only
342354|NCT00323284|O1|Outcome|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
342355|NCT00323284|E2|Reported Event|B--Cataract Surgery Only|Cataract Surgery only
342356|NCT00323284|E1|Reported Event|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
342357|NCT00323297|B3|Baseline|Total|Total of all reporting groups
342358|NCT00323297|B2|Baseline|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
342359|NCT00323297|B1|Baseline|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
342360|NCT00323297|P2|Participant Flow|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
348240|NCT00352612|E1|Reported Event|Cephalexin|
342362|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
342363|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
342364|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
342366|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
342367|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
342368|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
342369|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
342370|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
342371|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
342372|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
342373|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
342374|NCT00323297|E2|Reported Event|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
342375|NCT00323297|E1|Reported Event|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.
In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
342376|NCT00323310|B1|Baseline|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342377|NCT00323310|P1|Participant Flow|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342378|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342379|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342380|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342381|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342382|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342383|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342384|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342385|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342386|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342387|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342388|NCT00323310|E1|Reported Event|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
342389|NCT00323362|B1|Baseline|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
342390|NCT00323362|P1|Participant Flow|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
415217|NCT00525174|O1|Outcome|Bangerter|
342392|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
342393|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
342394|NCT00323362|E1|Reported Event|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
342395|NCT00323427|B3|Baseline|Total|Total of all reporting groups
342396|NCT00323427|B2|Baseline|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
342397|NCT00323427|B1|Baseline|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
342398|NCT00323427|P2|Participant Flow|Hearing Aids|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
342942|NCT00325819|B1|Baseline|Acetaminophen|Subjects who were randomized to receive acetaminophen
342402|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
342403|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
342404|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
342405|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
342406|NCT00323427|E2|Reported Event|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
342407|NCT00323427|E1|Reported Event|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
342408|NCT00323479|B1|Baseline|Anastrozole 1 mg|Anastrozole 1 mg once daily
342409|NCT00323479|P1|Participant Flow|Anastrozole 1 mg|Anastrozole 1 mg once daily
342410|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
342411|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
342412|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
342413|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
342414|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
342415|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
342416|NCT00323479|E1|Reported Event|Anastrozole 1 mg|Anastrozole 1 mg once daily
342417|NCT00323492|B3|Baseline|Total|Total of all reporting groups
342418|NCT00323492|B2|Baseline|Maintain Baseline Regimen|Maintain baseline regimen.
342419|NCT00323492|B1|Baseline|Truvada|Truvada + NNRTI or PI.
342420|NCT00323492|P3|Participant Flow|Delayed Truvada|Truvada + NNRTI or PI (participants from the control group who switched NRTIs to Truvada during Study Phase 2).
342421|NCT00323492|P2|Participant Flow|Maintain Baseline Regimen|Maintain baseline regimen.
342422|NCT00323492|P1|Participant Flow|Truvada|Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
342423|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342424|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342425|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342426|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342427|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342428|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342429|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342430|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342431|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342432|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342433|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342434|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342435|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342436|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342437|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342438|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342439|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342440|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342441|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342442|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342443|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342444|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342445|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342446|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342447|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
342448|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
342449|NCT00323492|E3|Reported Event|All Truvada|"Truvada + NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups). The number of participants at risk is the number who started the study by switching to Truvada (Truvada group), plus those who started the study by maintaining their baseline regimen but who switched to Truvada during the study (Delayed Truvada group). The number of participants at risk increases over time (from 47 at baseline to 72 when the last switch to Truvada took place; 25 participants switched to Truvada from the maintain baseline regimen group in Study Phase 2)."
342450|NCT00323492|E2|Reported Event|Maintain Baseline Regimen|Maintain baseline regimen. The number of participants at risk is the number who started the study by maintaining their baseline regimen. Per protocol, participants in this group were allowed to switch to Truvada after Week 12 (Delayed TVD group), therefore the number of participants at risk declines over time (from 45 at baseline to 17 who completed Study Phase 2; with most participants switching to Truvada at Week 12).
342451|NCT00323492|E1|Reported Event|Truvada|Truvada + NNRTI or PI. The number of participants at risk is the number who started the study by switching to Truvada. Participants in this group were to remain on Truvada for 48 weeks (duration of the study). The number at risk was reduced only by study discontinuation (from 47 at baseline to 40 who completed Study Phase 2).
342452|NCT00323557|B3|Baseline|Total|Total of all reporting groups
342453|NCT00323557|B2|Baseline|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
342454|NCT00323557|B1|Baseline|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
342455|NCT00323557|P2|Participant Flow|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
342456|NCT00323557|P1|Participant Flow|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
342457|NCT00323557|O3|Outcome|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0. No CM-CSF.
342984|NCT00326001|B3|Baseline|Total|Total of all reporting groups
342458|NCT00323557|O2|Outcome|Pneumococcal Vaccine + Post Vaccine GM-CSF|Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given Day 0 (day of pneumococcal vaccine), and post vaccination at Day +3 and Day +7.
342459|NCT00323557|O1|Outcome|Pneumococcal Vaccine + Pre Vaccine GM-CSF|Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given pre vaccination Day -7, Day -1 and Day 0 (day of pneumococcal vaccine).
342460|NCT00323557|E2|Reported Event|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
342461|NCT00323557|E1|Reported Event|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
342462|NCT00323609|B3|Baseline|Total|Total of all reporting groups
342463|NCT00323609|B2|Baseline|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342464|NCT00323609|B1|Baseline|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342465|NCT00323609|P4|Participant Flow|Vertebroplasty Not Treated Patients|Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
342466|NCT00323609|P3|Participant Flow|Kyphoplasty Not Treated Patients|Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
342467|NCT00323609|P2|Participant Flow|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342468|NCT00323609|P1|Participant Flow|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342469|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342470|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342471|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342472|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342473|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342474|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342475|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342476|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342477|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342478|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342479|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342480|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342481|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342482|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342483|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342484|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342485|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342486|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342487|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342488|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342489|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342490|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342491|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342492|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342493|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342494|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342495|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342496|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
342497|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
342502|NCT00323622|B8|Baseline|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342503|NCT00323622|B7|Baseline|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342504|NCT00323622|B6|Baseline|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342505|NCT00323622|B5|Baseline|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342506|NCT00323622|B4|Baseline|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342507|NCT00323622|B3|Baseline|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342508|NCT00323622|B2|Baseline|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342509|NCT00323622|B1|Baseline|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342510|NCT00323622|P8|Participant Flow|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study
342511|NCT00323622|P7|Participant Flow|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342512|NCT00323622|P6|Participant Flow|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342513|NCT00323622|P5|Participant Flow|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342547|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
348241|NCT00352664|B3|Baseline|Total|Total of all reporting groups
342514|NCT00323622|P4|Participant Flow|Cohort 2-RTS,S/AS02A≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342515|NCT00323622|P3|Participant Flow|Cohort 2-RTS,S/AS02A<24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342516|NCT00323622|P2|Participant Flow|Cohort 1-RTS,S/AS02A≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342517|NCT00323622|P1|Participant Flow|Cohort 1-RTS,S/AS02A<24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection
342518|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
342519|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
342520|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
342521|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
342522|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
342523|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
342524|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
342525|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
342526|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
342527|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
342550|NCT00323622|E6|Reported Event|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
345049|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
342528|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
342529|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
342530|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
342531|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
342532|NCT00323622|O4|Outcome|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342533|NCT00323622|O3|Outcome|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342534|NCT00323622|O2|Outcome|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342535|NCT00323622|O1|Outcome|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342548|NCT00323622|E8|Reported Event|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342673|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342536|NCT00323622|O4|Outcome|Cohort 2-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-Engerix-B ≥24M and Cohort 2-Prevnar-Hiberix <24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342581|NCT00324857|B4|Baseline|Arm 4/ DA and MI|Decision aid and MI
342582|NCT00324857|B3|Baseline|Arm 3/ Motivational Interview (MI)|Motivational Interviewing
342583|NCT00324857|B2|Baseline|Arm 2/Decision Aid (DA)|Decision Aid video
345050|NCT00333814|O3|Outcome|Sham|Sham
342537|NCT00323622|O3|Outcome|Cohort 2-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-RTS,S/AS02A <24M and Cohort 2-RTS,S/AS02A ≥24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342538|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
342539|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
342540|NCT00323622|O8|Outcome|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342541|NCT00323622|O7|Outcome|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342542|NCT00323622|O6|Outcome|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342543|NCT00323622|O5|Outcome|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342544|NCT00323622|O4|Outcome|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342545|NCT00323622|O3|Outcome|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342546|NCT00323622|O2|Outcome|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342674|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342675|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342549|NCT00323622|E7|Reported Event|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342584|NCT00324857|B1|Baseline|Arm 1/Attention Control|Attention control
342832|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342551|NCT00323622|E5|Reported Event|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342552|NCT00323622|E4|Reported Event|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342553|NCT00323622|E3|Reported Event|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
342554|NCT00323622|E2|Reported Event|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342555|NCT00323622|E1|Reported Event|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
342556|NCT00323635|B3|Baseline|Total|Total of all reporting groups
342557|NCT00323635|B2|Baseline|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
342558|NCT00323635|B1|Baseline|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
342559|NCT00323635|P2|Participant Flow|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
342560|NCT00323635|P1|Participant Flow|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
342561|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
342562|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
342563|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
342564|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
342565|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
342566|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
342567|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
342568|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
342569|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
342570|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
342571|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
342572|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
342573|NCT00323635|E2|Reported Event|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
342574|NCT00323635|E1|Reported Event|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
342575|NCT00323739|B1|Baseline|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
342576|NCT00323739|P1|Participant Flow|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
342676|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
343077|NCT00326196|E1|Reported Event|Percutaneous Coronary Intervention|Percutaneous coronary intervention
342577|NCT00323739|O1|Outcome|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
342578|NCT00323739|O1|Outcome|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
342579|NCT00323739|E1|Reported Event|Bevacizumab + Everolimus|
342580|NCT00324857|B5|Baseline|Total|Total of all reporting groups
359138|NCT00381303|O1|Outcome|Female|
342585|NCT00324857|P4|Participant Flow|Arm 4/ DA and MI|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.
Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain"
342586|NCT00324857|P3|Participant Flow|Arm 3/ Motivational Interview (MI)|Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
342587|NCT00324857|P2|Participant Flow|Arm 2/Decision Aid (DA)|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
342588|NCT00324857|P1|Participant Flow|Arm 1/Attention Control|Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
342589|NCT00324857|O4|Outcome|Arm 4/ DA and MI|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.
Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain"
342590|NCT00324857|O3|Outcome|Arm 3/ Motivational Interview (MI)|Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
342591|NCT00324857|O2|Outcome|Arm 2/Decision Aid (DA)|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
342592|NCT00324857|O1|Outcome|Arm 1/Attention Control|Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
342593|NCT00324857|E4|Reported Event|Arm 4/ DA and MI|Decision Aid and MI
342594|NCT00324857|E3|Reported Event|Arm 3/ Motivational Interview (MI)|Motivational Interviewing
342595|NCT00324857|E2|Reported Event|Arm 2/Decision Aid (DA)|Decision Aid
342596|NCT00324857|E1|Reported Event|Arm 1/Attention Control|Attention Control
342597|NCT00324870|B1|Baseline|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.
vorinostat: Given orally
bevacizumab: Given IV"
342598|NCT00324870|P1|Participant Flow|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.
vorinostat: Given orally
bevacizumab: Given IV"
342643|NCT00325078|B3|Baseline|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
342737|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
342599|NCT00324870|O1|Outcome|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.
vorinostat: Given orally
bevacizumab: Given IV"
342600|NCT00324870|E1|Reported Event|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.
vorinostat: Given orally
bevacizumab: Given IV"
342601|NCT00324896|B3|Baseline|Total|Total of all reporting groups
342602|NCT00324896|B2|Baseline|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
342603|NCT00324896|B1|Baseline|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime
eszopiclone : eszopiclone"
342604|NCT00324896|P2|Participant Flow|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
342605|NCT00324896|P1|Participant Flow|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime
eszopiclone : eszopiclone"
342606|NCT00324896|O2|Outcome|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
342607|NCT00324896|O1|Outcome|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime
eszopiclone : eszopiclone"
342608|NCT00324896|O2|Outcome|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
342609|NCT00324896|O1|Outcome|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime
eszopiclone : eszopiclone"
342610|NCT00324896|E2|Reported Event|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
342611|NCT00324896|E1|Reported Event|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime
eszopiclone : eszopiclone"
342612|NCT00324961|B1|Baseline|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
342613|NCT00324961|P1|Participant Flow|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
342614|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
342615|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV|10 mg ADV tablets once daily for 104 weeks
342616|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
342617|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
342618|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
342619|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
342620|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
342621|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
342622|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
342623|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
342624|NCT00324961|E1|Reported Event|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
342625|NCT00325039|B3|Baseline|Total|Total of all reporting groups
342626|NCT00325039|B2|Baseline|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
342627|NCT00325039|B1|Baseline|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
342628|NCT00325039|P2|Participant Flow|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
342629|NCT00325039|P1|Participant Flow|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
342630|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
342631|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
342632|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
342633|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
342634|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
342635|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
342636|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
342637|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
342638|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
342639|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
342640|NCT00325039|E2|Reported Event|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
342641|NCT00325039|E1|Reported Event|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
342642|NCT00325078|B4|Baseline|Total|Total of all reporting groups
342644|NCT00325078|B2|Baseline|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
342645|NCT00325078|B1|Baseline|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.
Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
342646|NCT00325078|P3|Participant Flow|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
342647|NCT00325078|P2|Participant Flow|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
342684|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342685|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342648|NCT00325078|P1|Participant Flow|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.
Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
342649|NCT00325078|O2|Outcome|Observation|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
342650|NCT00325078|O1|Outcome|Treatment|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.
Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
342651|NCT00325078|O3|Outcome|Control Volunteers|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
342652|NCT00325078|O2|Outcome|Observation|Subjects with IBD without TNFa inhibitor treatment
342653|NCT00325078|O1|Outcome|Treatment|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.
Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
342654|NCT00325078|E3|Reported Event|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
342655|NCT00325078|E2|Reported Event|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
342656|NCT00325078|E1|Reported Event|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.
Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
342657|NCT00325130|B3|Baseline|Total|Total of all reporting groups
342658|NCT00325130|B2|Baseline|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342659|NCT00325130|B1|Baseline|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342660|NCT00325130|P2|Participant Flow|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342661|NCT00325130|P1|Participant Flow|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342662|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342663|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342664|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342665|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342666|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342667|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342668|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342669|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342670|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342671|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342738|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
342677|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342678|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342679|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342680|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342681|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342682|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342683|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
345051|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
342686|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342687|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342688|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342689|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342690|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342691|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342692|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342693|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342694|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342695|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342696|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342697|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342698|NCT00325130|E2|Reported Event|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342699|NCT00325130|E1|Reported Event|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
342700|NCT00325143|B1|Baseline|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
342701|NCT00325143|P1|Participant Flow|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
342702|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
342703|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
342704|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
342739|NCT00325195|E3|Reported Event|Placebo|placebo infusion every 2 weeks
342740|NCT00325195|E2|Reported Event|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
342741|NCT00325195|E1|Reported Event|q2 Wks|8 mg pegloticase every 2 weeks
342705|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
342706|NCT00325143|E1|Reported Event|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
345052|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
342707|NCT00325156|B1|Baseline|Infanrix-IPV+ Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
342708|NCT00325156|P1|Participant Flow|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
342709|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
342710|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
342711|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
342712|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
342713|NCT00325156|E1|Reported Event|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
342714|NCT00325195|B4|Baseline|Total|Total of all reporting groups
342715|NCT00325195|B3|Baseline|Placebo|placebo infusion every 2 weeks
342716|NCT00325195|B2|Baseline|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
342717|NCT00325195|B1|Baseline|q2 Wks|8 mg pegloticase every 2 weeks
342718|NCT00325195|P3|Participant Flow|Placebo|placebo infusion every 2 weeks
342719|NCT00325195|P2|Participant Flow|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
342720|NCT00325195|P1|Participant Flow|q2 Wks|8 mg pegloticase every 2 weeks
342721|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
342722|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
342723|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
342724|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
342725|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
342726|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
342727|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
342728|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
342729|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
342730|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
342731|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
342732|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
342733|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
342734|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
342735|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
342736|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
342743|NCT00325234|B2|Baseline|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
342744|NCT00325234|B1|Baseline|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
342745|NCT00325234|P2|Participant Flow|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
342746|NCT00325234|P1|Participant Flow|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
342747|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
342748|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
342749|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
342750|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
342751|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
342752|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
342753|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
342754|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
342755|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
342756|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
342757|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
342758|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.
342759|NCT00325234|E2|Reported Event|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
342760|NCT00325234|E1|Reported Event|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
342761|NCT00325403|B3|Baseline|Total|Total of all reporting groups
342762|NCT00325403|B2|Baseline|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population
342763|NCT00325403|B1|Baseline|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342764|NCT00325403|P2|Participant Flow|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.
342765|NCT00325403|P1|Participant Flow|Placebo|These subjects were randomly allocated to receive matching oral placebo twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.
342766|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
342767|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
343078|NCT00326417|B3|Baseline|Total|Total of all reporting groups
342768|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
342769|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
342770|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
342771|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
342772|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
342773|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
342774|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342775|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342937|NCT00325780|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
342776|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342777|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342778|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342779|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342780|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342781|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342782|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342783|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342784|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342785|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342786|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342787|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342788|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342789|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342790|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342791|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342792|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342793|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342794|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342795|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342796|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342797|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342798|NCT00325403|E2|Reported Event|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
342799|NCT00325403|E1|Reported Event|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
342800|NCT00325416|B3|Baseline|Total|Total of all reporting groups
342801|NCT00325416|B2|Baseline|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342802|NCT00325416|B1|Baseline|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342821|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342822|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342823|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
415218|NCT00525174|O2|Outcome|Patching|
342803|NCT00325416|P2|Participant Flow|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342804|NCT00325416|P1|Participant Flow|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342938|NCT00325780|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
342805|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342806|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342807|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342808|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342809|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342810|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342811|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342812|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342813|NCT00325416|E2|Reported Event|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342814|NCT00325416|E1|Reported Event|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
Phase II: Treatment at maximum tolerated dose (MTD)
Autologous Stem Cell Rescue: Day 0"
342815|NCT00325442|B3|Baseline|Total|Total of all reporting groups
342816|NCT00325442|B2|Baseline|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342817|NCT00325442|B1|Baseline|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342818|NCT00325442|P2|Participant Flow|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342819|NCT00325442|P1|Participant Flow|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342820|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342824|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342825|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342826|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342827|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342828|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342829|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342830|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342831|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
359139|NCT00381303|O5|Outcome|Other|
342833|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342834|NCT00325442|O3|Outcome|3.5 - 16 mg|Subjects in this group received 3.5 to 16 mg oral treprostinil twice daily.
342835|NCT00325442|O2|Outcome|1.25 - 3.25 mg|Subjects in this group recieved 1.25 to 3.25 mg oral treprostinil twice daily.
342836|NCT00325442|O1|Outcome|Less Than 1 mg or Discontinuation Due to Adverse Events|Subjects in this group received less than or equal to 1 mg oral treprostinil twice daily or discontinued treatment due to adverse events.
342837|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342838|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342839|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342840|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342841|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342842|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342843|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342844|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342845|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342846|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342847|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342848|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342849|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342850|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342851|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342852|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342853|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342854|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342855|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342856|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342857|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342858|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342859|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342860|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342861|NCT00325442|E2|Reported Event|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
342862|NCT00325442|E1|Reported Event|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
342863|NCT00325468|B6|Baseline|Total|Total of all reporting groups
342864|NCT00325468|B5|Baseline|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
342865|NCT00325468|B4|Baseline|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
342866|NCT00325468|B3|Baseline|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
342867|NCT00325468|B2|Baseline|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
342868|NCT00325468|B1|Baseline|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
342869|NCT00325468|P5|Participant Flow|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
342963|NCT00325897|B3|Baseline|Total|Total of all reporting groups
342870|NCT00325468|P4|Participant Flow|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
342871|NCT00325468|P3|Participant Flow|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
342872|NCT00325468|P2|Participant Flow|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
342873|NCT00325468|P1|Participant Flow|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
342874|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
342875|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
342876|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
342877|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
342878|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
342879|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
342880|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
342881|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
342882|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
342883|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
342884|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
342885|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
342886|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
342887|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
342888|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
342889|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
342890|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
342891|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
342892|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
342893|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
342964|NCT00325897|B2|Baseline|Placebo|Inactive sugar pill
342894|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
342895|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
342896|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
342939|NCT00325780|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
342940|NCT00325819|B3|Baseline|Total|Total of all reporting groups
342897|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
342898|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
342899|NCT00325468|E6|Reported Event|All Participants|
342900|NCT00325468|E5|Reported Event|Alendronate 70 mg QW|
342901|NCT00325468|E4|Reported Event|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
342902|NCT00325468|E3|Reported Event|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
342903|NCT00325468|E2|Reported Event|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
342904|NCT00325468|E1|Reported Event|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
342905|NCT00325598|B3|Baseline|Total|Total of all reporting groups
342906|NCT00325598|B2|Baseline|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)"
342907|NCT00325598|B1|Baseline|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)"
342908|NCT00325598|P2|Participant Flow|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)"
342909|NCT00325598|P1|Participant Flow|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)"
342910|NCT00325598|O2|Outcome|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)"
342911|NCT00325598|O1|Outcome|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)"
342912|NCT00325598|O2|Outcome|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)"
342913|NCT00325598|O1|Outcome|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)"
342914|NCT00325598|E4|Reported Event|Cohort 2 (40 Gy) Late Toxicities|"40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 91 through end of follow-up"
342915|NCT00325598|E3|Reported Event|Cohort 2 (40 Gy) Acute Toxicities|"40 Gy in 10 fractions BID over 5 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 91 through end of follow-up"
342916|NCT00325598|E2|Reported Event|Cohort 1 (36 Gy) Late Toxicities|"36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 1 through Day 90"
342917|NCT00325598|E1|Reported Event|Cohort 1 (36 Gy) Acute Toxicities|"36 Gy in 9 fractions BID x 4 1/2 treatment days
Partial Breast Irradiation (PBI)
Follow toxicities from Day 1 through Day 90"
342918|NCT00325754|B3|Baseline|Total|Total of all reporting groups
342919|NCT00325754|B2|Baseline|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
342920|NCT00325754|B1|Baseline|E-Cylinder|"22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
342921|NCT00325754|P2|Participant Flow|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
342922|NCT00325754|P1|Participant Flow|E-Cylinder|"22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
342923|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
342924|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
342925|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
342926|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
342927|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
342928|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
342929|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
342930|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
415219|NCT00525174|O1|Outcome|Bangerter|
342931|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
342932|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
342933|NCT00325754|E2|Reported Event|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
342934|NCT00325754|E1|Reported Event|E-Cylinder|"22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
342935|NCT00325780|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
342936|NCT00325780|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
359140|NCT00381303|O4|Outcome|Asian|
342943|NCT00325819|P2|Participant Flow|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination.
342944|NCT00325819|P1|Participant Flow|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
342945|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
342946|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
342947|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
342948|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
342949|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
342950|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
342951|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
342952|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
342953|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
342954|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
342955|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
342956|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
342957|NCT00325819|O2|Outcome|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
342958|NCT00325819|O1|Outcome|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
342959|NCT00325819|O2|Outcome|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
342960|NCT00325819|O1|Outcome|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
342961|NCT00325819|E2|Reported Event|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination.
342962|NCT00325819|E1|Reported Event|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
342969|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)
Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
342970|NCT00325897|O2|Outcome|Placebo|"Inactive
Placebo: Placebo taken on a daily basis"
342971|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)
Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
342972|NCT00325897|O2|Outcome|Placebo|"Inactive
Placebo: Placebo taken on a daily basis"
342973|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)
Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
342974|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
342975|NCT00325897|O1|Outcome|Azithromycin|Azithromycin 250 mg
342976|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
342977|NCT00325897|O1|Outcome|Azithromycin|Azithromycin, 250 mg
342978|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
342979|NCT00325897|O1|Outcome|Azithromycin|Azithromycin, 250 mg
342980|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
342981|NCT00325897|O1|Outcome|Azithromycin|Azithromycin 250 mg
342982|NCT00325897|E2|Reported Event|Placebo|Inactive sugar pill
342983|NCT00325897|E1|Reported Event|Azithromycin|Azithromycin, 250 mg
342985|NCT00326001|B2|Baseline|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
342986|NCT00326001|B1|Baseline|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
342987|NCT00326001|P2|Participant Flow|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
342988|NCT00326001|P1|Participant Flow|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
342989|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
342990|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
342991|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
342992|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
342993|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
342994|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
342995|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
342996|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
342997|NCT00326001|E2|Reported Event|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
342998|NCT00326001|E1|Reported Event|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
342999|NCT00326118|B3|Baseline|Total|Total of all reporting groups
343000|NCT00326118|B2|Baseline|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343001|NCT00326118|B1|Baseline|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343002|NCT00326118|P2|Participant Flow|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343003|NCT00326118|P1|Participant Flow|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343004|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343005|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343006|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343007|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343008|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343009|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343072|NCT00326196|P2|Participant Flow|Coronary Artery Bypass Graft|Initial revascularization with Coronary artery bypass graft (CABG). Multiple arterial conduits for suitable target vessels will be encouraged in the surgical treatment.
415220|NCT00525174|O2|Outcome|Patching|
343010|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343011|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343012|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343013|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343090|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
343091|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
343014|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343015|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343016|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343017|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343018|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343019|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343020|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343021|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343022|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343023|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343024|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343025|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343026|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm
343027|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343028|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343029|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343073|NCT00326196|P1|Participant Flow|Percutaneous Coronary Intervention|"Initial revascularization with Percutaneous coronary intervention. Whenever possible, drug-eluting stents will be used in the percutaneous treatment. The use of multiple stents to achieve a complete revascularization will be encouraged in the PCI treatment"
343030|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343031|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343032|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343033|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343034|NCT00326118|E2|Reported Event|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343035|NCT00326118|E1|Reported Event|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
343036|NCT00326170|B1|Baseline|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
343037|NCT00326170|P1|Participant Flow|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
343038|NCT00326170|O1|Outcome|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
343039|NCT00326170|E1|Reported Event|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
343040|NCT00326183|B3|Baseline|Total|Total of all reporting groups
343041|NCT00326183|B2|Baseline|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343042|NCT00326183|B1|Baseline|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343043|NCT00326183|P2|Participant Flow|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343044|NCT00326183|P1|Participant Flow|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343045|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343046|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343047|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343048|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343049|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343050|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343051|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343052|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343053|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343054|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343055|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343056|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343057|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343058|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343059|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343060|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343061|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343062|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343063|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343064|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343065|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343066|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343067|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
343068|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
343069|NCT00326196|B3|Baseline|Total|Total of all reporting groups
343070|NCT00326196|B2|Baseline|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
343071|NCT00326196|B1|Baseline|Percutaneous Coronary Intervention|Percutaneous coronary intervention
348242|NCT00352664|B2|Baseline|Placebo|Oral Placebo tablet daily x 7 days
343079|NCT00326417|B2|Baseline|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
343080|NCT00326417|B1|Baseline|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
343081|NCT00326417|P4|Participant Flow|Fludarabine|Fludarabine only (no Cyclophosphamide administered)
343082|NCT00326417|P3|Participant Flow|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
343083|NCT00326417|P2|Participant Flow|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
343084|NCT00326417|P1|Participant Flow|Cyclophosphamide 150mg|Fludarabine plus 150 mg/kg Cyclophosphamide (total dose)
343085|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
343086|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
343087|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
343088|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
343089|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
343092|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
343093|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
343094|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
343095|NCT00326417|E4|Reported Event|Fludarabine|Fludarabine only (no Cyclophosphamide administered)
343096|NCT00326417|E3|Reported Event|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
343097|NCT00326417|E2|Reported Event|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
343098|NCT00326417|E1|Reported Event|Cyclophosphamide 150mg|Fludarabine plus 150 mg/kg Cyclophosphamide (total dose)
343099|NCT00326495|B1|Baseline|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
343100|NCT00326495|P1|Participant Flow|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
343101|NCT00326495|O1|Outcome|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
343102|NCT00326495|O1|Outcome|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
343103|NCT00326495|E1|Reported Event|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)
BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.
Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
343104|NCT00326599|B5|Baseline|Total|Total of all reporting groups
343105|NCT00326599|B4|Baseline|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343106|NCT00326599|B3|Baseline|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343769|NCT00335283|E2|Reported Event|Placebo (Sugar Pill)|one tablet twice a day
415221|NCT00525174|O1|Outcome|Bangerter|
343107|NCT00326599|B2|Baseline|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343108|NCT00326599|B1|Baseline|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343109|NCT00326599|P4|Participant Flow|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343110|NCT00326599|P3|Participant Flow|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343111|NCT00326599|P2|Participant Flow|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343112|NCT00326599|P1|Participant Flow|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343113|NCT00326599|O1|Outcome|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343114|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343115|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343116|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343117|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343118|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343119|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343120|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343121|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343122|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343123|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343124|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343125|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343126|NCT00326599|E4|Reported Event|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343127|NCT00326599|E3|Reported Event|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343128|NCT00326599|E2|Reported Event|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343611|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
343129|NCT00326599|E1|Reported Event|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
343130|NCT00326612|B3|Baseline|Total|Total of all reporting groups
343131|NCT00326612|B2|Baseline|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
343132|NCT00326612|B1|Baseline|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
343133|NCT00326612|P2|Participant Flow|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
343134|NCT00326612|P1|Participant Flow|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
343135|NCT00326612|O2|Outcome|Rectal Diazepam|Includes intubation
343136|NCT00326612|O1|Outcome|Intranasal Midazolam|Patients who required oxygen at discharge from the Emergency Department
343137|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
343138|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
343139|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
343140|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
343141|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
343142|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
343143|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
343144|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
343145|NCT00326612|O2|Outcome|Rectal Diazepam|Includes intubation
343146|NCT00326612|O1|Outcome|Intranasal Midazolam|Patients who required oxygen at discharge from the Emergency Department
343147|NCT00326612|O2|Outcome|Rectal Diazepam|Median time to seizure cessation from medication administration to seizures stop time.
343148|NCT00326612|O1|Outcome|Intranasal Midazolam|Median time to seizure cessation from medication administration to seizures stop time.
343149|NCT00326612|E2|Reported Event|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
343150|NCT00326612|E1|Reported Event|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
343151|NCT00326716|B3|Baseline|Total|Total of all reporting groups
343152|NCT00326716|B2|Baseline|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343153|NCT00326716|B1|Baseline|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343154|NCT00326716|P4|Participant Flow|Infants ATV 400 mg / RTV 100 mg|Infants born to mothers receiving treatment with ATV 400 mg / RTV 100 mg during the third trimester of pregnancy.
343155|NCT00326716|P3|Participant Flow|Infants ATV 300 mg / RTV 100 mg|Infants born to mothers receiving treatment with ATV 300 mg / RTV 100 mg during the third trimester of pregnancy.
343156|NCT00326716|P2|Participant Flow|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343157|NCT00326716|P1|Participant Flow|Mother ATV 300 mg / RTV 100 mg|Mothers receiving atazanavir (ATV) / ritonavir (RTV) 300/100 mg once daily (QD) + lamivudine (ZDV) / zidovudine (3TC) 300/150 mg twice daily (BID) during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343158|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343159|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343160|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343161|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343162|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343163|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343505|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343164|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343165|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343166|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343167|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343258|NCT00326898|B1|Baseline|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
343168|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343169|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343170|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343171|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|Infansts of mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343172|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|Infants of mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343173|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg|Infants born to mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343174|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343175|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343176|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343177|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343178|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343179|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343180|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343181|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343182|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343183|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343506|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343184|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343185|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343186|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343187|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343188|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343189|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343190|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343191|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343192|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343193|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343194|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343195|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343196|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343197|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343198|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343199|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343200|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343201|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343202|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
343203|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
343204|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343612|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
343205|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343206|NCT00326716|O2|Outcome|All Infants|Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
343207|NCT00326716|O1|Outcome|All Treated Mothers|Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
343208|NCT00326716|O2|Outcome|All Infants|Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
343209|NCT00326716|O1|Outcome|All Treated Mothers|Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
343210|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|
343211|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|
343212|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343213|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343214|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343215|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343216|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343217|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343218|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343219|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343220|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343221|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343222|NCT00326716|E4|Reported Event|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343223|NCT00326716|E3|Reported Event|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
343224|NCT00326716|E2|Reported Event|Infant ATV 400 mg / RTV 100 mg|Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
343225|NCT00326716|E1|Reported Event|Infant ATV 300 mg / RTV 100 mg|Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
343226|NCT00326781|B3|Baseline|Total|Total of all reporting groups
343227|NCT00326781|B2|Baseline|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
343228|NCT00326781|B1|Baseline|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
343229|NCT00326781|P2|Participant Flow|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
343230|NCT00326781|P1|Participant Flow|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
343252|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
343231|NCT00326781|O2|Outcome|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
343232|NCT00326781|O1|Outcome|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
343233|NCT00326781|O2|Outcome|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
343234|NCT00326781|O1|Outcome|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
345053|NCT00333814|E3|Reported Event|Sham|Sham
343235|NCT00326781|E2|Reported Event|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
343236|NCT00326781|E1|Reported Event|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
343237|NCT00326872|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
343238|NCT00326872|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
343239|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
343240|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
343241|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
343242|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
343243|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
343244|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
343245|NCT00326872|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
343246|NCT00326885|B1|Baseline|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
343247|NCT00326885|P1|Participant Flow|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
343248|NCT00326885|O1|Outcome|Full Analysis Set|
343249|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
343250|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
343251|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
343507|NCT00333229|E2|Reported Event|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343253|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
343254|NCT00326885|E1|Reported Event|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
343255|NCT00326898|B4|Baseline|Total|Total of all reporting groups
343256|NCT00326898|B3|Baseline|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
343257|NCT00326898|B2|Baseline|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
343622|NCT00334633|B3|Baseline|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
343259|NCT00326898|P3|Participant Flow|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
343260|NCT00326898|P2|Participant Flow|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
343261|NCT00326898|P1|Participant Flow|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
343262|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
343263|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
343264|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
343265|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
343266|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
343267|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
343268|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
343269|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
343270|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
343271|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
343272|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
343273|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
343274|NCT00326898|E3|Reported Event|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
343275|NCT00326898|E2|Reported Event|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
343276|NCT00326898|E1|Reported Event|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
343277|NCT00326911|B3|Baseline|Total|Total of all reporting groups
343278|NCT00326911|B2|Baseline|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343292|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343279|NCT00326911|B1|Baseline|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343280|NCT00326911|P2|Participant Flow|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343337|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
345239|NCT00344487|E1|Reported Event|Group 1|
343281|NCT00326911|P1|Participant Flow|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343282|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343283|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343284|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343285|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343286|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343287|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343288|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343289|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343290|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343291|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343745|NCT00335257|O1|Outcome|OC DRSP-24d|24-day regimen of DRSP/EE
343293|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343294|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
345240|NCT00344500|B3|Baseline|Total|Total of all reporting groups
343295|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343296|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343297|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343298|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343299|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343300|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343301|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343302|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343303|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343304|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343305|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343746|NCT00335257|O5|Outcome|No Use|No (hormonal) contraception at last contact
343770|NCT00335283|E1|Reported Event|Lansoprazole|40 mg twice a day
343306|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343307|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343308|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343309|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343310|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343311|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343312|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343313|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343314|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343315|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343316|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343317|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343318|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343508|NCT00333229|E1|Reported Event|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343319|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343320|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343321|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343322|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343323|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343324|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343325|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343326|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343327|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343328|NCT00326911|E2|Reported Event|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343329|NCT00326911|E1|Reported Event|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
343330|NCT00326950|B1|Baseline|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
343331|NCT00326950|P1|Participant Flow|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
343332|NCT00326950|O1|Outcome|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, 2.0 mg/m^2.
343333|NCT00326950|O1|Outcome|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, 2.0 mg/m^2.
343334|NCT00326950|E1|Reported Event|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
343509|NCT00333359|B3|Baseline|Total|Total of all reporting groups
343771|NCT00335322|B4|Baseline|Total|Total of all reporting groups
343335|NCT00326963|B1|Baseline|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343336|NCT00326963|P1|Participant Flow|Enfuvirtide+PI+ARV’s|Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½” needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
343623|NCT00334633|B2|Baseline|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
343624|NCT00334633|B1|Baseline|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
343338|NCT00326963|O1|Outcome|Enfuride+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343339|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343340|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343341|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343342|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343343|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343344|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343345|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343346|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343347|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343348|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343349|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343350|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343351|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343352|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343353|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343354|NCT00326963|E1|Reported Event|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
343355|NCT00327015|B5|Baseline|Total|Total of all reporting groups
344274|NCT00324259|B2|Baseline|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
343356|NCT00327015|B4|Baseline|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
343357|NCT00327015|B3|Baseline|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
343358|NCT00327015|B2|Baseline|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343512|NCT00333359|P2|Participant Flow|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
359141|NCT00381303|O3|Outcome|Hispanic|
343359|NCT00327015|B1|Baseline|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343360|NCT00327015|P4|Participant Flow|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
343361|NCT00327015|P3|Participant Flow|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
343362|NCT00327015|P2|Participant Flow|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343363|NCT00327015|P1|Participant Flow|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343364|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
343365|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343366|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343367|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
343368|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343369|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343370|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
343371|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343372|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343373|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
343374|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343375|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343376|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
343377|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343510|NCT00333359|B2|Baseline|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343378|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343379|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
343539|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343380|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343381|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343382|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
343383|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343384|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343385|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
343386|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343387|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343388|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
343389|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343390|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343391|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
343392|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343393|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343394|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
343395|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343396|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343397|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
343398|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343399|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343608|NCT00334295|B1|Baseline|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
348376|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
343400|NCT00327015|E4|Reported Event|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343617|NCT00334542|P1|Participant Flow|Simvastatin|Simvastatin 40 mg for 24-28 weeks
343618|NCT00334542|O1|Outcome|Simvastatin|Simvastatin 40 mg for 24-28 weeks
343619|NCT00334542|O1|Outcome|Simvastatin|Simvastatin 40 mg for 24-28 weeks
343401|NCT00327015|E3|Reported Event|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
343402|NCT00327015|E2|Reported Event|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
343403|NCT00327015|E1|Reported Event|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
343404|NCT00327171|B3|Baseline|Total|Total of all reporting groups
343405|NCT00327171|B2|Baseline|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343406|NCT00327171|B1|Baseline|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343407|NCT00327171|P2|Participant Flow|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343408|NCT00327171|P1|Participant Flow|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343409|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343410|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343411|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343412|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343413|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343414|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343415|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343416|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343417|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343418|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343419|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343420|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343421|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343422|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343423|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343424|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343425|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343426|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343427|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343428|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343429|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343430|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343431|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343432|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343433|NCT00327171|E2|Reported Event|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
343434|NCT00327171|E1|Reported Event|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
343435|NCT00327340|B3|Baseline|Total|Total of all reporting groups
343459|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343460|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343436|NCT00327340|B2|Baseline|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
343437|NCT00327340|B1|Baseline|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
343438|NCT00327340|P2|Participant Flow|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
343439|NCT00327340|P1|Participant Flow|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
343440|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
343441|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
343442|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
343443|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
343444|NCT00327340|O2|Outcome|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
343445|NCT00327340|O1|Outcome|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
343446|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
343447|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
343448|NCT00327340|E2|Reported Event|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
343449|NCT00327340|E1|Reported Event|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
343450|NCT00333138|B4|Baseline|Total|Total of all reporting groups
343451|NCT00333138|B3|Baseline|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343452|NCT00333138|B2|Baseline|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343453|NCT00333138|B1|Baseline|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343454|NCT00333138|P3|Participant Flow|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343455|NCT00333138|P2|Participant Flow|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343456|NCT00333138|P1|Participant Flow|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343457|NCT00333138|O2|Outcome|FTY720 5.0 mg/Day|Patients randomized to fingolimod 5.0 mg/d in the core study who received fingolimod 5.0 mg/d in the dose-blind period of the extension study. All patients received fingolimod 1.25 mg/d initially in the open-label period and were later converted to fingolimod 0.5 mg/d.
343458|NCT00333138|O1|Outcome|FTY720 1.25 mg/Day|Patients randomized to fingolimod 1.25 mg/d in the core study who received fingolimod 1.25 mg/d in the dose-blind period of the extension study and initially in the open-label period and were later converted to fingolimod 0.5 mg/d.
343503|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343461|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343462|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343463|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343464|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343465|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343466|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343467|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343468|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343469|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343470|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343471|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343472|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343473|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343474|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343475|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343476|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343477|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343478|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343504|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343511|NCT00333359|B1|Baseline|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
359142|NCT00381303|O2|Outcome|Caucasian|
343479|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343480|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343481|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343482|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343483|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343484|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343485|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343486|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343487|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343488|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343489|NCT00333138|E3|Reported Event|Fingolimod (FTY720) 5.0 mg|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343490|NCT00333138|E2|Reported Event|Fingolimod (FTY720) 1.25 mg|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343491|NCT00333138|E1|Reported Event|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
343492|NCT00333229|B3|Baseline|Total|Total of all reporting groups
343493|NCT00333229|B2|Baseline|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343494|NCT00333229|B1|Baseline|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343495|NCT00333229|P2|Participant Flow|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343496|NCT00333229|P1|Participant Flow|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343497|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343498|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343499|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343500|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343501|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
343502|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
359143|NCT00381303|O1|Outcome|Black|
343513|NCT00333359|P1|Participant Flow|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343514|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343515|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343516|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343517|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343518|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343519|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343520|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343521|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343522|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343523|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343524|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343525|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343526|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343527|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343528|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343529|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343530|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343531|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343532|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343533|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343534|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343535|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343536|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
344275|NCT00324259|B1|Baseline|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
343537|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343538|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343540|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343541|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343542|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343543|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343544|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343545|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343546|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343547|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343548|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343549|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343550|NCT00333359|E3|Reported Event|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343551|NCT00333359|E2|Reported Event|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343552|NCT00333359|E1|Reported Event|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
343553|NCT00334061|B1|Baseline|Penumbra System|
343554|NCT00334061|P1|Participant Flow|Penumbra System|
343555|NCT00334061|O1|Outcome|Penumbra System|
343556|NCT00334061|O1|Outcome|Penumbra System|
343557|NCT00334061|O1|Outcome|Penumbra System|
343558|NCT00334061|O1|Outcome|Penumbra System|
343559|NCT00334061|O1|Outcome|Penumbra System|
343560|NCT00334061|O1|Outcome|Penumbra System|
343561|NCT00334061|E1|Reported Event|Penumbra System|
343562|NCT00334074|B1|Baseline|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.
343563|NCT00334074|P1|Participant Flow|Clofarabine and Cytarabine|5 consecutive days of Clofarabine 40 mg/m^2 intravenous infusion over 1 hour followed 4 hours later by cytarabine 1000mg/m^2 intravenous infusion over 2 hours.Next cycle will start approximately 4 weeks after Day 1 of previous cycle. Patients will receive a maximum of 4 cycles of study treatment.
343564|NCT00334074|O1|Outcome|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.
343565|NCT00334074|O1|Outcome|Clofarabine Plus Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Four hours post clofarabine infusion,Give cytarabine 1000 mg/m2 IV infusion over 2 hours.Patients will receive a maximum upto 4 cycles of study treatment.Next cycle will start approximately 4 weeks after Day 1 of previous cycle.
343566|NCT00334074|E1|Reported Event|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 intravenous infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 intravenous infusion 4 hours post clofarabine IVI.
343567|NCT00334113|B3|Baseline|Total|Total of all reporting groups
343568|NCT00334113|B2|Baseline|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
343609|NCT00334295|P1|Participant Flow|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
343610|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
348380|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
343569|NCT00334113|B1|Baseline|TLC-PED|"Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program."
343620|NCT00334542|E1|Reported Event|Simvastatin|Simvastatin 40 mg for 24-28 weeks
343570|NCT00334113|P2|Participant Flow|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
343571|NCT00334113|P1|Participant Flow|TLC-PED|"Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program."
343572|NCT00334113|O2|Outcome|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
343573|NCT00334113|O1|Outcome|TLC-PED|Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
343574|NCT00334113|E2|Reported Event|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
343575|NCT00334113|E1|Reported Event|TLC-PED|Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
343576|NCT00334204|B1|Baseline|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
343577|NCT00334204|P1|Participant Flow|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
343578|NCT00334204|O1|Outcome|Measure Platelet Function Analyser-100 (PFA-100)|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
343579|NCT00334204|O1|Outcome|Measure Platelet Function Analyser-100 (PFA-100)|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
343580|NCT00334204|O1|Outcome|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
343581|NCT00334204|E1|Reported Event|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
343582|NCT00334282|B3|Baseline|Total|Total of all reporting groups
343583|NCT00334282|B2|Baseline|Placebo|Matching Placebo administered once a day
343584|NCT00334282|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
343585|NCT00334282|P2|Participant Flow|Placebo|Matching Placebo administered orally once a day
343586|NCT00334282|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
343587|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
343588|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
343589|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered once daily
343590|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
343591|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
343592|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
343593|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
343594|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
343595|NCT00334282|O1|Outcome|Pazopanib|Pazopanib 800 mg (tablets) administered orally once a day
343596|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
343597|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
343598|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
343599|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
343600|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered orally once a day
343601|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
343602|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered orally once a day
343603|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
343604|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered once a day
343605|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
343606|NCT00334282|E2|Reported Event|Placebo|Matching Placebo administered orally once a day
343607|NCT00334282|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
344276|NCT00324259|P2|Participant Flow|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
343613|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
343614|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
343615|NCT00334295|E1|Reported Event|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
343616|NCT00334542|B1|Baseline|Simvastatin|Simvastatin 40 mg for 24-28 weeks
343625|NCT00334633|P3|Participant Flow|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
343626|NCT00334633|P2|Participant Flow|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
343627|NCT00334633|P1|Participant Flow|Metronidazole|metronidazole 500 twice a day (BID) for 7 days; 197 participants
343628|NCT00334633|O3|Outcome|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
343629|NCT00334633|O2|Outcome|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
343630|NCT00334633|O1|Outcome|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
343631|NCT00334633|E3|Reported Event|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
343632|NCT00334633|E2|Reported Event|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
343633|NCT00334633|E1|Reported Event|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
343634|NCT00334802|B3|Baseline|Total|Total of all reporting groups
343635|NCT00334802|B2|Baseline|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343636|NCT00334802|B1|Baseline|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343637|NCT00334802|P2|Participant Flow|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343638|NCT00334802|P1|Participant Flow|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343639|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
343640|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
343641|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
343642|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
343643|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
343644|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
343645|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343646|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343647|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343648|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343649|NCT00334802|O1|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343650|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343651|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343652|NCT00334802|E2|Reported Event|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343653|NCT00334802|E1|Reported Event|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
343654|NCT00334815|B3|Baseline|Total|Total of all reporting groups
343655|NCT00334815|B2|Baseline|High Risk Patient Stratum|
343656|NCT00334815|B1|Baseline|Low Risk Patient Stratum|
343657|NCT00334815|P2|Participant Flow|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC"
350452|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
343658|NCT00334815|P1|Participant Flow|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC"
343659|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC"
343695|NCT00335140|O1|Outcome|Rituximab + Standard Chemotherapy|"rituximab
cytarabine
dexamethasone
leucovorin calcium
methotrexate
procarbazine hydrochloride
vincristine sulfate"
343835|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
343660|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC"
343661|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC"
343662|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC"
343663|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC"
343664|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.
Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
cisplatin: Given IV
etoposide: Given IV
radiation therapy: Undergo thoracic radiotherapy
docetaxel: Given IV
filgrastim: Given SC
pegfilgrastim: Given SC"
343665|NCT00334815|O2|Outcome|Consolidation Therapy With Docetaxel and Bevacizumab.|
343666|NCT00334815|O1|Outcome|Concurrent Chemotherapy and Radiotherapy|
343667|NCT00334815|E2|Reported Event|Consolidation Therapy With Docetaxel and Bevacizumab|All eligible patients, both low-risk and high-risk strata combined, who received consolidation therapy with Docetaxel and Bevacizumab.
343668|NCT00334815|E1|Reported Event|Concurrent Chemotherapy and Radiotherapy|All eligible patients, both low-risk and high-risk strata combined, who received concurrent chemotherapy and radiotherapy.
343669|NCT00334893|B3|Baseline|Total|Total of all reporting groups
343670|NCT00334893|B2|Baseline|Platinum-Sensitive Cohort|Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
343671|NCT00334893|B1|Baseline|Platinum-Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV"
343672|NCT00334893|P2|Participant Flow|Platinum Sensitive Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV"
343673|NCT00334893|P1|Participant Flow|Platinum Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV"
343674|NCT00334893|O2|Outcome|Platinum-Sensitive Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV"
343675|NCT00334893|O1|Outcome|Platinum-Resistant Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV"
343676|NCT00334893|E2|Reported Event|Platinum-Sensitive Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV"
343677|NCT00334893|E1|Reported Event|Platinum-Resistant Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV"
343678|NCT00334958|B3|Baseline|Total|Total of all reporting groups
343747|NCT00335257|O4|Outcome|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)
343748|NCT00335257|O3|Outcome|OCs Non-DRSP|Users of OCs containing other progestins than DRSP
343749|NCT00335257|O2|Outcome|OC DRSP-21d|21-day regimen of DRSP/EE
343679|NCT00334958|B2|Baseline|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
343680|NCT00334958|B1|Baseline|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
343777|NCT00335322|P1|Participant Flow|TDF/FTC+EFV|
343681|NCT00334958|P2|Participant Flow|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
343682|NCT00334958|P1|Participant Flow|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
343683|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
343684|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
343685|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
343686|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
343687|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
343688|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
343689|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
343690|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
343691|NCT00334958|E2|Reported Event|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
343750|NCT00335257|O1|Outcome|OC DRSP-24d|24-day regimen of DRSP/EE
343751|NCT00335257|E5|Reported Event|No Use|No (hormonal) contraception)
343692|NCT00334958|E1|Reported Event|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
343693|NCT00335140|B1|Baseline|Rituximab + Standard Chemotherapy|"rituximab
cytarabine
dexamethasone
leucovorin calcium
methotrexate
procarbazine hydrochloride
vincristine sulfate"
343694|NCT00335140|P1|Participant Flow|Rituximab + Standard Chemotherapy|"rituximab
cytarabine
dexamethasone
leucovorin calcium
methotrexate
procarbazine hydrochloride
vincristine sulfate"
343778|NCT00335322|O3|Outcome|TDF/FTC+AZT+ABC|
343779|NCT00335322|O2|Outcome|TDF/FTC+r/ATV|
343696|NCT00335140|E1|Reported Event|Rituximab + Standard Chemotherapy|Rituximab + high dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine. Patients with meningeal involvement will receive additional methotrexate and leucovorin.
343697|NCT00335153|B1|Baseline|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343698|NCT00335153|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive levodopa-carbidopa intestinal gel (LCIG), via the nasojejunal (NJ) tube during the NJ Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343699|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343700|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343701|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343702|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343703|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343704|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343752|NCT00335257|E4|Reported Event|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or patches)
343753|NCT00335257|E3|Reported Event|OCs Non-DRSP|Users of OCs containing other progestins
343754|NCT00335257|E2|Reported Event|DRSP-21d|21-day regimen of DRSP/EE
343705|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343780|NCT00335322|O1|Outcome|TDF/FTC+EFV|
343781|NCT00335322|E3|Reported Event|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
343782|NCT00335322|E2|Reported Event|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
343783|NCT00335322|E1|Reported Event|TDF/FTC+EFV|
343706|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343707|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343708|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343709|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343710|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343711|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343712|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343713|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343714|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343755|NCT00335257|E1|Reported Event|DRSP-24d|24-day regimen of DRSP/EE
343756|NCT00335283|B3|Baseline|Total|Total of all reporting groups
343757|NCT00335283|B2|Baseline|Placebo (Sugar Pill)|one tablet twice a day
343758|NCT00335283|B1|Baseline|Lansoprazole|40 mg twice a day
343759|NCT00335283|P2|Participant Flow|Placebo (Sugar Pill)|one tablet twice a day
343760|NCT00335283|P1|Participant Flow|Lansoprazole|40 mg twice a day
343715|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343716|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343717|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343718|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343719|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343720|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343721|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343722|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343723|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343724|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343761|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
343762|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
343763|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
343764|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
343765|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
343766|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
343725|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343726|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343727|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343728|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343729|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343730|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343731|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343732|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343733|NCT00335153|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.
The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
343734|NCT00335257|B4|Baseline|Total|Total of all reporting groups
343735|NCT00335257|B3|Baseline|OCs Non-DRSP|Users of OCs containing other progestins
343736|NCT00335257|B2|Baseline|OC DRSP-21d|OCs containing DRSP (Yasmin®, 21 day regimen)
343737|NCT00335257|B1|Baseline|OC DRSP-24d|OCs containing DRSP (Yaz®, 24 day regimen )
343738|NCT00335257|P3|Participant Flow|OCs Non-DRSP|Users of OCs containing other progestins
343739|NCT00335257|P2|Participant Flow|OC DRSP-21d|OCs containing DRSP (Yasmin®, 21 day regimen)
343740|NCT00335257|P1|Participant Flow|OC DRSP-24d|OCs containing DRSP (Yaz®, 24 day regimen)
343741|NCT00335257|O5|Outcome|No Use|No (hormonal) contraception
343742|NCT00335257|O4|Outcome|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)
343743|NCT00335257|O3|Outcome|OCs Non-DRSP|Users of OCs containing other progestins
343744|NCT00335257|O2|Outcome|OC DRSP-21d|21-day regimen of DRSP/EE
343772|NCT00335322|B3|Baseline|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
343773|NCT00335322|B2|Baseline|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
343774|NCT00335322|B1|Baseline|TDF/FTC+EFV|
343775|NCT00335322|P3|Participant Flow|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
343776|NCT00335322|P2|Participant Flow|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
343789|NCT00335452|P4|Participant Flow|Clopidogrel 600/150/75 mg + ASA High Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
343790|NCT00335452|P3|Participant Flow|Clopidogrel 600/150/75 mg + ASA Low Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
343791|NCT00335452|P2|Participant Flow|Clopidogrel 300/75/75 mg + ASA High Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
343792|NCT00335452|P1|Participant Flow|Clopidogrel 300/75/75 mg + ASA Low Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
343793|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
343794|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
343795|NCT00335452|O2|Outcome|Clopidogrel + ASA High Dose|Patients treated with ASA high dose irrespective of the Clopidogrel treatment regimen
343796|NCT00335452|O1|Outcome|Clopidogrel + ASA Low Dose|Patients treated with ASA low dose irrespective of the Clopidogrel treatment regimen
343797|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
343798|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
343799|NCT00335452|O4|Outcome|Clopidogrel 600/150/75 mg + ASA High Dose|
343800|NCT00335452|O3|Outcome|Clopidogrel 600/150/75 mg + ASA Low Dose|
343801|NCT00335452|O2|Outcome|Clopidogrel 300/75/75 mg + ASA High Dose|
343802|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA Low Dose|
343803|NCT00335452|O2|Outcome|Clopidogrel + ASA High Dose|Patients treated with ASA high dose irrespective of the Clopidogrel treatment regimen
343804|NCT00335452|O1|Outcome|Clopidogrel + ASA Low Dose|Patients treated with ASA low dose irrespective of the Clopidogrel treatment regimen
343805|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose.
343806|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
343807|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
343808|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
343809|NCT00335452|E4|Reported Event|Clopidogrel 600/150/75 mg + ASA High Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
343810|NCT00335452|E3|Reported Event|Clopidogrel 600/150/75 mg + ASA Low Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
343811|NCT00335452|E2|Reported Event|Clopidogrel 300/75/75 mg + ASA High Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
343812|NCT00335452|E1|Reported Event|Clopidogrel 300/75/75 mg + ASA Low Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
343813|NCT00335478|B1|Baseline|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
343814|NCT00335478|P1|Participant Flow|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
343815|NCT00335478|O1|Outcome|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
343816|NCT00335478|E1|Reported Event|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
343817|NCT00335504|B5|Baseline|Total|Total of all reporting groups
343818|NCT00335504|B4|Baseline|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
343819|NCT00335504|B3|Baseline|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
343820|NCT00335504|B2|Baseline|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
343821|NCT00335504|B1|Baseline|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
343822|NCT00335504|P4|Participant Flow|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
343823|NCT00335504|P3|Participant Flow|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
343824|NCT00335504|P2|Participant Flow|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
343825|NCT00335504|P1|Participant Flow|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
343826|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
343827|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
343828|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
343829|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
343830|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
343831|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
343832|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
343833|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
343834|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
343836|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
343837|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
343838|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
343839|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
343840|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
343841|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
343842|NCT00335504|E4|Reported Event|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
343843|NCT00335504|E3|Reported Event|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
343844|NCT00335504|E2|Reported Event|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
343845|NCT00335504|E1|Reported Event|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
343846|NCT00335517|B1|Baseline|Injection|DepoDur Injection
343847|NCT00335517|P1|Participant Flow|Injection|DepoDur Injection
343848|NCT00335517|O1|Outcome|Injection|DepoDur Injection
343849|NCT00335517|E1|Reported Event|Injection|DepoDur Injection
343850|NCT00335556|B7|Baseline|Total|Total of all reporting groups
343851|NCT00335556|B6|Baseline|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
343852|NCT00335556|B5|Baseline|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
343853|NCT00335556|B4|Baseline|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
343854|NCT00335556|B3|Baseline|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
343855|NCT00335556|B2|Baseline|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
343856|NCT00335556|B1|Baseline|Surgery|Surgery Only
343857|NCT00335556|P6|Participant Flow|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
343858|NCT00335556|P5|Participant Flow|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
343859|NCT00335556|P4|Participant Flow|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
343860|NCT00335556|P3|Participant Flow|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
343861|NCT00335556|P2|Participant Flow|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
343862|NCT00335556|P1|Participant Flow|Surgery|Surgery Only
343863|NCT00335556|O4|Outcome|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT
343864|NCT00335556|O3|Outcome|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
343865|NCT00335556|O2|Outcome|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
343866|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide;x 30 weeks; XRT.
343867|NCT00335556|O2|Outcome|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
343868|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
343869|NCT00335556|O1|Outcome|Combined UH-2, UH-1, Window/UH-1|Combined UH-1, UH-2, and Window/UH-1 for revised-UH toxicity monitoring
343870|NCT00335556|O1|Outcome|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
343871|NCT00335556|O1|Outcome|Combined Window/UH-1 and UH-2|Combine window/UH-1 and UH-2 for response rate monitoring for window therapy.
343872|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphamide; x 30 weeks; XRT.
343873|NCT00335556|O3|Outcome|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
350542|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
343874|NCT00335556|O2|Outcome|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
343875|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
343876|NCT00335556|E6|Reported Event|Regimen DD-4A|"Vincristine/dactinomycin/doxorubicin x25 weeks; XRT"
343877|NCT00335556|E5|Reported Event|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT
343878|NCT00335556|E4|Reported Event|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
343879|NCT00335556|E3|Reported Event|Window/UH-1|"Window therapy of vincristine/irinotecan; Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT"
343880|NCT00335556|E2|Reported Event|UH-1|Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT
343881|NCT00335556|E1|Reported Event|Surgery|Surgery Only
343882|NCT00335725|B3|Baseline|Total|Total of all reporting groups
343883|NCT00335725|B2|Baseline|Gonal-f|
343884|NCT00335725|B1|Baseline|Fostimon|
343885|NCT00335725|P2|Participant Flow|Gonal-f|Recombinant FSH
343886|NCT00335725|P1|Participant Flow|Fostimon|Highly purified FSH
343887|NCT00335725|O2|Outcome|Gonal-F|
343888|NCT00335725|O1|Outcome|Fostimon|
343889|NCT00335725|O2|Outcome|Gonal-f|
343890|NCT00335725|O1|Outcome|Fostimon|
343891|NCT00335725|E2|Reported Event|Gonal-F|
343892|NCT00335725|E1|Reported Event|Fostimon|
343893|NCT00335777|B1|Baseline|Migranal: All Subjects|All subjects enrolled in study
343894|NCT00335777|P1|Participant Flow|Migranal: All Subjects|All subjects enrolled in study
343895|NCT00335777|O2|Outcome|Migranal Late Treatment|Treated a headache at greater or equal to 3.5 hours after onset of throbbing
343896|NCT00335777|O1|Outcome|Migranal: Early Treatment|Treated headache within 1.25 hours of onset of throbbing
343897|NCT00335777|E1|Reported Event|Migranal: All Subjects|All subjects enrolled in study
343898|NCT00335829|B1|Baseline|Single Arm, Received Bevacizumab and TACE|"bevacizumab
chemotherapy
embolization therapy
hepatic artery infusion"
343899|NCT00335829|P1|Participant Flow|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343900|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343901|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343902|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343903|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343904|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343905|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343906|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343907|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343908|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343909|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343910|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
343911|NCT00335829|E1|Reported Event|Single Arm, Received Bevacizumab and TACE|"bevacizumab
chemotherapy
embolization therapy
hepatic artery infusion"
343912|NCT00335959|B1|Baseline|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
343959|NCT00336323|P1|Participant Flow|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
344277|NCT00324259|P1|Participant Flow|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
343913|NCT00335959|P1|Participant Flow|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
343914|NCT00335959|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
343915|NCT00335959|O1|Outcome|Chemotherapy, Chemoradiation and Surgery|Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
343916|NCT00335959|E1|Reported Event|Chemotherapy, Chemoradiation and Surgery|Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
343917|NCT00335972|B3|Baseline|Total|Total of all reporting groups
344293|NCT00324259|E2|Reported Event|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
343918|NCT00335972|B2|Baseline|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
343919|NCT00335972|B1|Baseline|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical
Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
343920|NCT00335972|P2|Participant Flow|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
343921|NCT00335972|P1|Participant Flow|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical
Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
343922|NCT00335972|O2|Outcome|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
343923|NCT00335972|O1|Outcome|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical
Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
343924|NCT00335972|O2|Outcome|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
343925|NCT00335972|O1|Outcome|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical
Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
343960|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343961|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343962|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343963|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343926|NCT00335972|O2|Outcome|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
343927|NCT00335972|O1|Outcome|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical
Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
343971|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
343972|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
344004|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
343928|NCT00335972|E2|Reported Event|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
343929|NCT00335972|E1|Reported Event|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical
Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
343930|NCT00336232|B1|Baseline|Diet Intervention|"5 day baseline vitamin K
Vitamin K: phylloquinone (vitamin K1) 200 mcg daily
28 day diet low vitamin K
Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days
treatment started day 6, completed day 33
28 day diet high vitamin K
Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month
treatment started day 34, ended day 61"
343931|NCT00336232|P1|Participant Flow|Vitamin K Diet Intervention|"5 day baseline vitamin K
Vitamin K: phylloquinone (vitamin K1) 200 mcg daily
28 day diet low vitamin K
Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days
treatment started day 6, completed day 33
28 day diet high vitamin K
Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month
treatment started day 34, ended day 61"
343932|NCT00336232|O1|Outcome|Diet Intervention|"5 day baseline vitamin K
Vitamin K: phylloquinone (vitamin K1) 200 mcg daily
28 day diet low vitamin K
Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days
treatment started day 6, completed day 33
28 day diet high vitamin K
Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month
treatment started day 34, ended day 61"
343933|NCT00336232|E1|Reported Event|Diet Intervention|"5 day baseline vitamin K
Vitamin K: phylloquinone (vitamin K1) 200 mcg daily
28 day diet low vitamin K
Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days
treatment started day 6, completed day 33
28 day diet high vitamin K
Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month
treatment started day 34, ended day 61"
343934|NCT00336284|B3|Baseline|Total|Total of all reporting groups
343935|NCT00336284|B2|Baseline|Conventional|Home Monitoring programmed OFF
343936|NCT00336284|B1|Baseline|Home Monitoring|Home Monitoring programmed ON
343937|NCT00336284|P2|Participant Flow|Conventional|Home Monitoring programmed OFF
343938|NCT00336284|P1|Participant Flow|Home Monitoring|Home Monitoring programmed ON
343939|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
343940|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
343941|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
343942|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
343943|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
343944|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
343945|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
343946|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
343947|NCT00336284|E2|Reported Event|Conventional|Home Monitoring programmed OFF
343948|NCT00336284|E1|Reported Event|Home Monitoring|Home Monitoring programmed ON
343949|NCT00336323|B6|Baseline|Total|Total of all reporting groups
343950|NCT00336323|B5|Baseline|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
343951|NCT00336323|B4|Baseline|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
343952|NCT00336323|B3|Baseline|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343953|NCT00336323|B2|Baseline|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343954|NCT00336323|B1|Baseline|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
343955|NCT00336323|P5|Participant Flow|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
343956|NCT00336323|P4|Participant Flow|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
343957|NCT00336323|P3|Participant Flow|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343958|NCT00336323|P2|Participant Flow|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
344395|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
343964|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343965|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343966|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343967|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343968|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343969|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
343970|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
343973|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343974|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343975|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343976|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343977|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343978|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343979|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343980|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343981|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343982|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343983|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343984|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343985|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343986|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343987|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
343988|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
343989|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
343990|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343991|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343992|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
343993|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
343994|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
343995|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343996|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
343997|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
343998|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
343999|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
344000|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
344001|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
344002|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
344003|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
345315|NCT00345839|B3|Baseline|Total|Total of all reporting groups
344005|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
344006|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
344007|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
344008|NCT00336323|E5|Reported Event|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
344009|NCT00336323|E4|Reported Event|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
344010|NCT00336323|E3|Reported Event|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
344011|NCT00336323|E2|Reported Event|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
344012|NCT00336323|E1|Reported Event|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
344013|NCT00336479|B5|Baseline|Total|Total of all reporting groups
344014|NCT00336479|B4|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
344015|NCT00336479|B3|Baseline|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
344016|NCT00336479|B2|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
344017|NCT00336479|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
344018|NCT00336479|P4|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
344019|NCT00336479|P3|Participant Flow|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
344020|NCT00336479|P2|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
344021|NCT00336479|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
344022|NCT00336479|O1|Outcome|Telaprevir|All Subjects from “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week”, “Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week”, and “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week” reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks.
344023|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
344024|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
344025|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
344026|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
344045|NCT00336492|B2|Baseline|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
344027|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
344028|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
344029|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
344030|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
344031|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
344032|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
344033|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
344034|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
344035|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
344036|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
344037|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
344038|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
344039|NCT00336479|E4|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
344396|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344040|NCT00336479|E3|Reported Event|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
344041|NCT00336479|E2|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
344042|NCT00336479|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
344043|NCT00336492|B4|Baseline|Total|Total of all reporting groups
344044|NCT00336492|B3|Baseline|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
344046|NCT00336492|B1|Baseline|Not Randomized Group|Participants who were not randomized at Week 8
344047|NCT00336492|P3|Participant Flow|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
344048|NCT00336492|P2|Participant Flow|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
344049|NCT00336492|P1|Participant Flow|Not Randomized Group|Participants who were not randomized at Week 8
344050|NCT00336492|O2|Outcome|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
344051|NCT00336492|O1|Outcome|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
344052|NCT00336492|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg group
344053|NCT00336492|E3|Reported Event|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
344054|NCT00336492|E2|Reported Event|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
344055|NCT00336492|E1|Reported Event|Not Randomized Group|Participants who were not randomized at Week 8
344056|NCT00336505|B3|Baseline|Total|Total of all reporting groups
344057|NCT00336505|B2|Baseline|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344058|NCT00336505|B1|Baseline|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344059|NCT00336505|P2|Participant Flow|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344060|NCT00336505|P1|Participant Flow|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344061|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344062|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344063|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344064|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344065|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344066|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344067|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344068|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344069|NCT00336505|E2|Reported Event|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344070|NCT00336505|E1|Reported Event|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344071|NCT00336544|B3|Baseline|Total|Total of all reporting groups
344072|NCT00336544|B2|Baseline|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344073|NCT00336544|B1|Baseline|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344074|NCT00336544|P2|Participant Flow|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344075|NCT00336544|P1|Participant Flow|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344076|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344077|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344078|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344079|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344080|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344081|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344082|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344083|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344084|NCT00336544|E2|Reported Event|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
344085|NCT00336544|E1|Reported Event|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
344086|NCT00336583|B1|Baseline|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
344236|NCT00324168|B2|Baseline|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344087|NCT00336583|P1|Participant Flow|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
344088|NCT00336583|O1|Outcome|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
344089|NCT00336583|O1|Outcome|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
344090|NCT00336583|E1|Reported Event|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
344091|NCT00323869|B1|Baseline|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:
15 mg/kg bevacizumab Day 1 of each cycle
1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
Carboplatin (AUC of 5 every 3 weeks)"
344140|NCT00323882|O6|Outcome|All Treated Participants|All participants in all treatment arms combined.
344243|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344092|NCT00323869|P1|Participant Flow|Bevacizumab + Carboplatin + Gemcitabine|"Bevacizumab in combination with carboplatin and gemcitabine
Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity Gemcitabine, administered 1000 mg/m2 IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles
Carboplatin was administered before gemcitabine infusion.
Bevacizumab was administered 1 hour after end of all chemotherapy infusions.
Bevacizumab: Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody
Gemcitabine: Nucleoside analog
Carboplatin: Alkylating agent"
344093|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:
15 mg/kg bevacizumab Day 1 of each cycle
1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
Carboplatin (AUC of 5 every 3 weeks)"
344094|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:
15 mg/kg bevacizumab Day 1 of each cycle
1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
Carboplatin (AUC of 5 every 3 weeks)"
344095|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:
15 mg/kg bevacizumab Day 1 of each cycle
1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
Carboplatin (AUC of 5 every 3 weeks)"
344096|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:
15 mg/kg bevacizumab Day 1 of each cycle
1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
Carboplatin (AUC of 5 every 3 weeks)"
344097|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:
15 mg/kg bevacizumab Day 1 of each cycle
1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
Carboplatin (AUC of 5 every 3 weeks)"
344098|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:
15 mg/kg bevacizumab Day 1 of each cycle
1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
Carboplatin (AUC of 5 every 3 weeks)"
344099|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:
15 mg/kg bevacizumab Day 1 of each cycle
1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
Carboplatin (AUC of 5 every 3 weeks)"
344100|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:
15 mg/kg bevacizumab Day 1 of each cycle
1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
Carboplatin (AUC of 5 every 3 weeks)"
344101|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:
15 mg/kg bevacizumab Day 1 of each cycle
1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
Carboplatin (AUC of 5 every 3 weeks)"
344102|NCT00323869|E1|Reported Event|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:
15 mg/kg bevacizumab Day 1 of each cycle
1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
Carboplatin (AUC of 5 every 3 weeks)"
344103|NCT00323882|B6|Baseline|Total|Total of all reporting groups
344104|NCT00323882|B5|Baseline|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344105|NCT00323882|B4|Baseline|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344106|NCT00323882|B3|Baseline|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344271|NCT00324233|E2|Reported Event|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
344107|NCT00323882|B2|Baseline|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344108|NCT00323882|B1|Baseline|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344244|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344294|NCT00324259|E1|Reported Event|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
344109|NCT00323882|P5|Participant Flow|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344110|NCT00323882|P4|Participant Flow|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to Response Evaluation Criteria in Solid Tumors (RECIST), target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344111|NCT00323882|P3|Participant Flow|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344112|NCT00323882|P2|Participant Flow|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses (maintenance). The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344113|NCT00323882|P1|Participant Flow|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of the induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344114|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344115|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344116|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344237|NCT00324168|B1|Baseline|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344397|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344117|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344118|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344295|NCT00324272|B5|Baseline|Total|Total of all reporting groups
344119|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344120|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344121|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344122|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344123|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344124|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344125|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344126|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344127|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344398|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344128|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344223|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
344291|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
344129|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344130|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344131|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344132|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344133|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344134|NCT00323882|O6|Outcome|All Treated Participants|All treatment groups are combined to show total overall survival at completion of Follow Up.
344135|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344136|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344137|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344138|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344238|NCT00324168|P2|Participant Flow|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344399|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344139|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344141|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344142|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344143|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344144|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344145|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344146|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344147|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344148|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344149|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344150|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344222|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
344151|NCT00323882|O3|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|In those participants with no prior chemotherapy, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344152|NCT00323882|O2|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|In those who received chemotherapy prior to enrolling in this study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344153|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344154|NCT00323882|O3|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|In those participants who had received no chemotherapy prior to the study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344155|NCT00323882|O2|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|In those who received chemotherapy prior to enrolling in this study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344156|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344157|NCT00323882|O6|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344158|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344239|NCT00324168|P1|Participant Flow|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344272|NCT00324233|E1|Reported Event|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
344159|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344160|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344161|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344162|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344163|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344164|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344165|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344166|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344167|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344168|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344220|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression, (PD) unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
344169|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344170|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344171|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344172|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344173|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344174|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344175|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344176|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344177|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344178|NCT00323882|E5|Reported Event|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344221|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
344267|NCT00324233|P2|Participant Flow|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
344273|NCT00324259|B3|Baseline|Total|Total of all reporting groups
344179|NCT00323882|E4|Reported Event|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344180|NCT00323882|E3|Reported Event|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344181|NCT00323882|E2|Reported Event|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344182|NCT00323882|E1|Reported Event|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
344183|NCT00324038|B3|Baseline|Total|Total of all reporting groups
344184|NCT00324038|B2|Baseline|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
344185|NCT00324038|B1|Baseline|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
344186|NCT00324038|P2|Participant Flow|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
344187|NCT00324038|P1|Participant Flow|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
344188|NCT00324038|O2|Outcome|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
344189|NCT00324038|O1|Outcome|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
344190|NCT00324038|E2|Reported Event|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
344191|NCT00324038|E1|Reported Event|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
344192|NCT00324116|B1|Baseline|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
344193|NCT00324116|P1|Participant Flow|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
344194|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
344195|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
344196|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
344197|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
344198|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
344199|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
344200|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
344201|NCT00324116|E1|Reported Event|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
344202|NCT00324155|B3|Baseline|Total|Total of all reporting groups
344203|NCT00324155|B2|Baseline|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
344204|NCT00324155|B1|Baseline|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
344205|NCT00324155|P2|Participant Flow|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
344268|NCT00324233|P1|Participant Flow|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
344206|NCT00324155|P1|Participant Flow|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
344207|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
344208|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
344209|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
344210|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
344211|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
344212|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10m g/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
344213|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
344214|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
344215|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
344216|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
344217|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
344218|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In maintenance phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
344219|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
344269|NCT00324233|O2|Outcome|SpediCath Compact Male|
344270|NCT00324233|O1|Outcome|SpeediCath|
344224|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1e dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
344225|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
344226|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
344227|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
344228|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
344229|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
344230|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
344231|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
344232|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
344233|NCT00324155|E2|Reported Event|Placebo + Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
344234|NCT00324155|E1|Reported Event|10 mg/kg Ipilimumab + Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.
Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.
In Maintenance Phase: Only Ipilimumab: 10mg/kg, every 12 wks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
344235|NCT00324168|B3|Baseline|Total|Total of all reporting groups
344240|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344241|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344242|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344292|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
344245|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344246|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344247|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344248|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344249|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344250|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344251|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344252|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344253|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344254|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344255|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344256|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344257|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344258|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344259|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344260|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344261|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344262|NCT00324168|E2|Reported Event|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344263|NCT00324168|E1|Reported Event|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
344264|NCT00324233|B3|Baseline|Total|Total of all reporting groups
344265|NCT00324233|B2|Baseline|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
344266|NCT00324233|B1|Baseline|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
344400|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344278|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol) and Arm 2 (30 mg Estradiol)|"Arm 1 = 6 mg of estradiol daily (2 mg tid).
Arm 2 = 30 mg of estradiol. (10 mg tid)"
344279|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
344280|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
344281|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
344282|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
344283|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
344284|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
344285|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
344286|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
344287|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
344288|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
344289|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
344290|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
344296|NCT00324272|B4|Baseline|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344297|NCT00324272|B3|Baseline|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344298|NCT00324272|B2|Baseline|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344299|NCT00324272|B1|Baseline|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344300|NCT00324272|P4|Participant Flow|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344301|NCT00324272|P3|Participant Flow|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344302|NCT00324272|P2|Participant Flow|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344303|NCT00324272|P1|Participant Flow|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344401|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344304|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344305|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344306|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344421|NCT00324701|O2|Outcome|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
344307|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344308|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344309|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344310|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344311|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344312|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344313|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344314|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344339|NCT00324350|P2|Participant Flow|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344315|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344316|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344328|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344317|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344318|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344319|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344320|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344321|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344322|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344323|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344324|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344325|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344326|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344327|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344329|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344330|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344331|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344332|NCT00324272|E4|Reported Event|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344333|NCT00324272|E3|Reported Event|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344334|NCT00324272|E2|Reported Event|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344335|NCT00324272|E1|Reported Event|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
344336|NCT00324350|B3|Baseline|Total|Total of all reporting groups
344337|NCT00324350|B2|Baseline|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344338|NCT00324350|B1|Baseline|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344393|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344340|NCT00324350|P1|Participant Flow|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344341|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344342|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344343|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344344|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%) in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344345|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344420|NCT00324701|O1|Outcome|Telepsychology|therapy done at patients house using in-home video conferencing technology
344518|NCT00342355|B3|Baseline|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
344346|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344347|NCT00324350|E2|Reported Event|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344348|NCT00324350|E1|Reported Event|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
344349|NCT00324415|B1|Baseline|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
344350|NCT00324415|P1|Participant Flow|Combined Modality Therapy|Combined modality therapy consists of cisplatin, 5-flourouracil, and irradiation plus cetuximab
344351|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
344352|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
344353|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
344354|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
344355|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
344356|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
344357|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
344358|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
344359|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
344360|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
344361|NCT00324415|E1|Reported Event|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
344362|NCT00324649|B3|Baseline|Total|Total of all reporting groups
344363|NCT00324649|B2|Baseline|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344364|NCT00324649|B1|Baseline|Truvada|Truvada + NNRTI or PI.
344365|NCT00324649|P2|Participant Flow|Zidovudine/Lamivudine|Zidovudine/lamivudine + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
344366|NCT00324649|P1|Participant Flow|Truvada|Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
344367|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344368|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344369|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344370|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344371|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344372|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344373|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344374|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344375|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344376|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344377|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344378|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344379|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344380|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344381|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344382|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344383|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344384|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344385|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344386|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344387|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344388|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344389|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344390|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344391|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344392|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344394|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
344403|NCT00324649|E2|Reported Event|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
344404|NCT00324649|E1|Reported Event|Truvada|Truvada + NNRTI or PI.
344405|NCT00324675|B3|Baseline|Total|Total of all reporting groups
344406|NCT00324675|B2|Baseline|Placebo|
344407|NCT00324675|B1|Baseline|Rosiglitazone|
344408|NCT00324675|P2|Participant Flow|Placebo|
344409|NCT00324675|P1|Participant Flow|Rosiglitazone|
344410|NCT00324675|O2|Outcome|Placebo|
344411|NCT00324675|O1|Outcome|Rosiglitazone|
344412|NCT00324675|E2|Reported Event|Placebo|
344413|NCT00324675|E1|Reported Event|Rosiglitazone|
344414|NCT00324701|B3|Baseline|Total|Total of all reporting groups
344415|NCT00324701|B2|Baseline|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
344416|NCT00324701|B1|Baseline|Telepsychology|therapy done at patients house using in-home video conferencing technology
344417|NCT00324701|P2|Participant Flow|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
344418|NCT00324701|P1|Participant Flow|Telepsychology|therapy done at patients house using in-home video conferencing technology
344419|NCT00324701|O2|Outcome|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
344422|NCT00324701|O1|Outcome|Telepsychology|therapy done at patients house using in-home video conferencing technology
344423|NCT00324701|E2|Reported Event|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
344424|NCT00324701|E1|Reported Event|Telepsychology|therapy done at patients house using in-home video conferencing technology
344425|NCT00324740|B1|Baseline|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally"
344426|NCT00324740|P3|Participant Flow|Dose Level 3: Vorinostat (300mg) and Isotretinoin (0.5 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.5 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally"
344427|NCT00324740|P2|Participant Flow|Dose Level 2 Vorinostat (300mg) and Isotretinoin (0.375 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.375 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally"
344428|NCT00324740|P1|Participant Flow|Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.25 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally"
344429|NCT00324740|O1|Outcome|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally"
344430|NCT00324740|O3|Outcome|Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.5 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally"
344431|NCT00324740|O2|Outcome|Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.375 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally"
344432|NCT00324740|O1|Outcome|Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally"
344433|NCT00324740|E1|Reported Event|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally"
344434|NCT00330343|B1|Baseline|Group 1|
344435|NCT00330343|P1|Participant Flow|Naloxone|
344436|NCT00330343|O1|Outcome|Naloxone|
344437|NCT00330343|E1|Reported Event|Group 1|
344438|NCT00330382|B3|Baseline|Total|Total of all reporting groups
344439|NCT00330382|B2|Baseline|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
344440|NCT00330382|B1|Baseline|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies"
344441|NCT00330382|P2|Participant Flow|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
344442|NCT00330382|P1|Participant Flow|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies"
344443|NCT00330382|O1|Outcome|Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups|"Patients receive oral Bowman-Birk inhibitor concentrate or Placebo twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally Placebo: Given orally laboratory biomarker analysis: Correlative studies"
344444|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
350624|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
344445|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies"
344446|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
344447|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies"
344448|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
344449|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies"
344450|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
344451|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies"
344452|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
345754|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
344453|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies"
344454|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
344455|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies"
344456|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
344457|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies"
344458|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
344459|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies"
344460|NCT00330382|E2|Reported Event|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies"
344461|NCT00330382|E1|Reported Event|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies"
344462|NCT00336700|B1|Baseline|Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
344463|NCT00336700|P1|Participant Flow|Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
344464|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
344465|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
344466|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
344467|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
344468|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
344469|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
344470|NCT00336700|E1|Reported Event|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|
344471|NCT00336817|B3|Baseline|Total|Total of all reporting groups
344472|NCT00336817|B2|Baseline|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344473|NCT00336817|B1|Baseline|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344474|NCT00336817|P2|Participant Flow|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344475|NCT00336817|P1|Participant Flow|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344572|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
344476|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344477|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344478|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344479|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344480|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344481|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344482|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days
Results: 2 participants in the CellCept group discontinued drug use"
344483|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days
Results: 1 participant in the Myfortic arm left at 6 weeks into the study to start hemodialysis"
346096|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
344484|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days
Results: 2 participants in the CellCept group discontinued drug use"
344485|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days
Results: 1 participant in the Myfortic arm left at 6 weeks into the study to start hemodialysis"
344486|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344487|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344488|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344489|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344490|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344491|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344492|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344493|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344494|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344495|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344496|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344497|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344498|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344499|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344500|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344501|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344502|NCT00336817|E2|Reported Event|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
CellCept: CellCept 500mg or 1000mg BID for 90 days"
344503|NCT00336817|E1|Reported Event|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
344504|NCT00336856|B1|Baseline|IRINOTECAN AND CETUXIMAB|Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC who received Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV), followed by 500 mg/m2 every 2 weeks IV
344505|NCT00336856|P1|Participant Flow|IRINOTECAN AND CETUXIMAB|Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC
344506|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.
Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
344507|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.
Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
344508|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.
Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
344573|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
344509|NCT00336856|E1|Reported Event|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.
Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
344510|NCT00336895|B1|Baseline|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
344511|NCT00336895|P1|Participant Flow|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
344512|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
344513|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
344514|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
344515|NCT00336895|E1|Reported Event|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
344516|NCT00342355|B5|Baseline|Total|Total of all reporting groups
344517|NCT00342355|B4|Baseline|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
344519|NCT00342355|B2|Baseline|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
344520|NCT00342355|B1|Baseline|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
344521|NCT00342355|P4|Participant Flow|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
344522|NCT00342355|P3|Participant Flow|d4T + 3TC + EFV|Stavudine + Lamivudine + Efavirenz
344523|NCT00342355|P2|Participant Flow|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
344524|NCT00342355|P1|Participant Flow|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
344525|NCT00342355|O4|Outcome|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
344526|NCT00342355|O3|Outcome|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
344527|NCT00342355|O2|Outcome|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
344528|NCT00342355|O1|Outcome|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
344529|NCT00342355|O4|Outcome|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
344530|NCT00342355|O3|Outcome|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
344531|NCT00342355|O2|Outcome|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
344532|NCT00342355|O1|Outcome|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
344533|NCT00342355|E4|Reported Event|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
344534|NCT00342355|E3|Reported Event|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
344535|NCT00342355|E2|Reported Event|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
344536|NCT00342355|E1|Reported Event|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
344537|NCT00342563|B5|Baseline|Total|Total of all reporting groups
344538|NCT00342563|B4|Baseline|Placebo- Non-Smoker|
344539|NCT00342563|B3|Baseline|Placebo-Smoker|Placebo: Placebo
344540|NCT00342563|B2|Baseline|Mecamylamine-Non-Smoker|
344541|NCT00342563|B1|Baseline|Mecamylamine-Smoker|mecamylamine: mecamylamine 10mg/day
344542|NCT00342563|P4|Participant Flow|Placebo Non-Smoker|
344543|NCT00342563|P3|Participant Flow|Placebo Smoker|
344544|NCT00342563|P2|Participant Flow|Mecamylamine Non-Smoker|
344545|NCT00342563|P1|Participant Flow|Mecamylamine- Smoker|mecamylamine: mecamylamine 10mg/day
344546|NCT00342563|O2|Outcome|Placebo|Placebo: Placebo
344547|NCT00342563|O1|Outcome|Mecamylamine|mecamylamine: mecamylamine 10mg/day
344548|NCT00342563|O2|Outcome|Placebo|Placebo: Placebo
344549|NCT00342563|O1|Outcome|Mecamylamine|mecamylamine: mecamylamine 10mg/day
344550|NCT00342563|O2|Outcome|Placebo|Placebo: Placebo
344551|NCT00342563|O1|Outcome|Mecamylamine|mecamylamine: mecamylamine 10mg/day
344552|NCT00342563|O4|Outcome|Placebo- Non-Smoker|
344553|NCT00342563|O3|Outcome|Placebo-Smoker|Placebo
344554|NCT00342563|O2|Outcome|Mecamylamine- Non-Smoker|mecamylamine: mecamylamine 10mg/day
344555|NCT00342563|O1|Outcome|Mecamylamine- Smokers|mecamylamine: mecamylamine 10mg/day
344556|NCT00342563|E4|Reported Event|Placebo Non-Smoker|Placebo: Placebo
344557|NCT00342563|E3|Reported Event|Placebo Smoker|Placebo: Placebo
344558|NCT00342563|E2|Reported Event|Mecamylamine Non-Smoker|mecamylamine: mecamylamine 10mg/day
344559|NCT00342563|E1|Reported Event|Mecamylamine Smoker|mecamylamine: mecamylamine 10mg/day
344560|NCT00342628|B4|Baseline|Total|Total of all reporting groups
344561|NCT00342628|B3|Baseline|DTP Vaccines|DTP at 2, 4, and 6 months of age
344562|NCT00342628|B2|Baseline|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
344563|NCT00342628|B1|Baseline|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
344564|NCT00342628|P3|Participant Flow|DTP Vaccines|DTP at 2, 4, and 6 months of age
344565|NCT00342628|P2|Participant Flow|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
344566|NCT00342628|P1|Participant Flow|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
344567|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
344568|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
344569|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
344570|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
344571|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
344574|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
344575|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
344576|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
344577|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
344578|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
344579|NCT00342628|E3|Reported Event|DTP Vaccines|DTP at 2, 4, and 6 months of age
344580|NCT00342628|E2|Reported Event|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
344581|NCT00342628|E1|Reported Event|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
344582|NCT00343044|B1|Baseline|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
344583|NCT00343044|P1|Participant Flow|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
344781|NCT00343564|B2|Baseline|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
344584|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
344585|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
344586|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
344587|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
344588|NCT00343044|E1|Reported Event|Arm 1|Patients (N=40)
344589|NCT00343083|B1|Baseline|Cetuximab (ERBITUX) and Concurrent Carboplatin|
344590|NCT00343083|P1|Participant Flow|Cetuximab (ERBITUX) and Concurrent Carboplatin|". Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy. Chemotherapy will be given every week for a total of 8 weeks. Paclitaxel will be given at a dose of 40 mg/m2 as a 1 hour infusion dose followed by cetuximab and then carboplatin AUC = 2/week.
The initial dose of cetuximab is 400 mg/m2 IV on day 1, followed by weekly infusions at 250 mg/m2 IV."
344591|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
344592|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
344593|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
344594|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
344595|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
344596|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
344597|NCT00343083|E1|Reported Event|Cetuximab (ERBITUX) and Concurrent Carboplatin|
344598|NCT00343252|B3|Baseline|Total|Total of all reporting groups
344599|NCT00343252|B2|Baseline|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344600|NCT00343252|B1|Baseline|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344601|NCT00343252|P2|Participant Flow|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344602|NCT00343252|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344603|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344604|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344605|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344606|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344607|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344608|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344609|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344610|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344611|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344612|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344613|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344614|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344615|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344616|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344617|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344618|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344619|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344620|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344621|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344622|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344623|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344624|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344625|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344626|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344627|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344628|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344629|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344630|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344631|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344632|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344633|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344634|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344635|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344636|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344637|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344638|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344639|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344640|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344641|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344642|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344643|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344644|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344645|NCT00343252|E2|Reported Event|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
344646|NCT00343252|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
344647|NCT00343291|B3|Baseline|Total|Total of all reporting groups
344648|NCT00343291|B2|Baseline|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Cycles 1-3:
Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles
Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344649|NCT00343291|B1|Baseline|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Paclitaxel 200mg/m² on day 1 of every 3 week cycle
Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle
Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344650|NCT00343291|P2|Participant Flow|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Cycles 1-3:
Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles
Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344664|NCT00343382|B4|Baseline|Total|Total of all reporting groups
344665|NCT00343382|B3|Baseline|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
344666|NCT00343382|B2|Baseline|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
344717|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344651|NCT00343291|P1|Participant Flow|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Paclitaxel 200mg/m² on day 1 of every 3 week cycle
Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle
Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344652|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Cycles 1-3:
Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles
Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344653|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Paclitaxel 200mg/m² on day 1 of every 3 week cycle
Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle
Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344677|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
344654|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Cycles 1-3:
Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles
Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344655|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Paclitaxel 200mg/m² on day 1 of every 3 week cycle
Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle
Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344656|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Cycles 1-3:
Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles
Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344657|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Paclitaxel 200mg/m² on day 1 of every 3 week cycle
Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle
Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344658|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Cycles 1-3:
Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles
Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344659|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Paclitaxel 200mg/m² on day 1 of every 3 week cycle
Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle
Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344660|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Cycles 1-3:
Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles
Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344661|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Paclitaxel 200mg/m² on day 1 of every 3 week cycle
Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle
Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344662|NCT00343291|E2|Reported Event|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Cycles 1-3:
Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles
Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344663|NCT00343291|E1|Reported Event|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:
Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
Paclitaxel 200mg/m² on day 1 of every 3 week cycle
Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle
Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
344667|NCT00343382|B1|Baseline|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
344668|NCT00343382|P3|Participant Flow|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
344669|NCT00343382|P2|Participant Flow|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
344670|NCT00343382|P1|Participant Flow|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
344671|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
344672|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
344673|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
344674|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
344675|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
344676|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
346177|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
344678|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
344679|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
344680|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
344681|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
344682|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
344683|NCT00343382|E3|Reported Event|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
344684|NCT00343382|E2|Reported Event|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
344685|NCT00343382|E1|Reported Event|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
344686|NCT00343460|B7|Baseline|Total|Total of all reporting groups
344687|NCT00343460|B6|Baseline|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344688|NCT00343460|B5|Baseline|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344689|NCT00343460|B4|Baseline|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344690|NCT00343460|B3|Baseline|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344691|NCT00343460|B2|Baseline|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344692|NCT00343460|B1|Baseline|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344693|NCT00343460|P3|Participant Flow|Aloxi 0.25 mg|Aloxi 0.25 mg - Safety Population
344694|NCT00343460|P2|Participant Flow|APF530 10 mg|APF530 10 mg - Safety Population
344695|NCT00343460|P1|Participant Flow|APF530 5 mg|APF530 5 mg - Safety Population
344696|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344697|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344698|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344699|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344700|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344701|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344702|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344703|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344704|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344705|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344706|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344707|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344708|NCT00343460|O4|Outcome|Cycles 1, 2, 3, and 4 - Highly|APF530 10 mg
344709|NCT00343460|O3|Outcome|Cycles 1, 2, 3 and 4 - Highly|APF530 5 mg
344710|NCT00343460|O2|Outcome|Cycles 1, 2, 3, and 4 - Moderately|APF530 10 mg
344711|NCT00343460|O1|Outcome|Cycles 1, 2, 3 and 4 - Moderately|APF530 5 mg
344712|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344713|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344714|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344715|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344716|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344921|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
344718|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344719|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344720|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344721|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344722|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344723|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344724|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344725|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344726|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344727|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344728|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344729|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344730|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344731|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344732|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344733|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344734|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344735|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344736|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344737|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344738|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344739|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344740|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344741|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344742|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344743|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344744|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344745|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344746|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344747|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344748|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344749|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344750|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344751|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344752|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344753|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344754|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344755|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344756|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Highly"
344757|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344758|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344759|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population
Emetogenic Status: Moderately"
344760|NCT00343460|E5|Reported Event|Cycle 2-4 APF530 10 mg|Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
344761|NCT00343460|E4|Reported Event|Cycles 2-4 APF530 5 mg|Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
344762|NCT00343460|E3|Reported Event|Cycle 1 Aloxi 0.25 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
344763|NCT00343460|E2|Reported Event|Cycle 1 APF530 10 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
344764|NCT00343460|E1|Reported Event|Cycle 1 APF530 5 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
344765|NCT00343512|B1|Baseline|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
344766|NCT00343512|P1|Participant Flow|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
350625|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
344767|NCT00343512|O1|Outcome|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
344768|NCT00343512|O1|Outcome|Therapeutic Intervention|
344769|NCT00343512|O1|Outcome|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
344770|NCT00343512|E1|Reported Event|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
344771|NCT00343564|B12|Baseline|Total|Total of all reporting groups
344772|NCT00343564|B11|Baseline|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
344773|NCT00343564|B10|Baseline|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
344774|NCT00343564|B9|Baseline|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
344775|NCT00343564|B8|Baseline|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
344776|NCT00343564|B7|Baseline|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
344777|NCT00343564|B6|Baseline|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
344778|NCT00343564|B5|Baseline|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
344779|NCT00343564|B4|Baseline|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
344780|NCT00343564|B3|Baseline|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
344782|NCT00343564|B1|Baseline|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
344783|NCT00343564|P11|Participant Flow|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
344784|NCT00343564|P10|Participant Flow|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
344785|NCT00343564|P9|Participant Flow|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
344786|NCT00343564|P8|Participant Flow|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
344787|NCT00343564|P7|Participant Flow|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
344788|NCT00343564|P6|Participant Flow|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
344789|NCT00343564|P5|Participant Flow|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
344790|NCT00343564|P4|Participant Flow|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
344791|NCT00343564|P3|Participant Flow|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
344792|NCT00343564|P2|Participant Flow|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
344793|NCT00343564|P1|Participant Flow|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
344794|NCT00343564|O2|Outcome|Dose Escalation Cohorts 7-11 (w/ GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support (cohorts 7,8,9,10 and 11)
344795|NCT00343564|O1|Outcome|Dose Escalation Cohorts 1-6 (w/o GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support (cohorts 1,2,3,4,5 and 6).
344796|NCT00343564|E11|Reported Event|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
344797|NCT00343564|E10|Reported Event|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
344798|NCT00343564|E9|Reported Event|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
344799|NCT00343564|E8|Reported Event|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
344800|NCT00343564|E7|Reported Event|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
344801|NCT00343564|E6|Reported Event|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
344802|NCT00343564|E5|Reported Event|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
344803|NCT00343564|E4|Reported Event|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
344804|NCT00343564|E3|Reported Event|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
344805|NCT00343564|E2|Reported Event|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
344806|NCT00343564|E1|Reported Event|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
344807|NCT00343785|B1|Baseline|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
344808|NCT00343785|P1|Participant Flow|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
344809|NCT00343785|O1|Outcome|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
344810|NCT00343785|O1|Outcome|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
344872|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
350626|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
344811|NCT00343785|O1|Outcome|Patients Receive a Conditioning Regimen Comprising Cyclophosph|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
344812|NCT00343785|E1|Reported Event|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
344813|NCT00343863|B3|Baseline|Total|Total of all reporting groups
344814|NCT00343863|B2|Baseline|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344815|NCT00343863|B1|Baseline|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344935|NCT00333437|E1|Reported Event|Treatment|Study subjects receive standard mycophenolate dosing.
344816|NCT00343863|P2|Participant Flow|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344817|NCT00343863|P1|Participant Flow|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344818|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
344819|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
344820|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344821|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344822|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344823|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344824|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344825|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344826|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344827|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344828|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344829|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344830|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344831|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344832|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344833|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344834|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344835|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344920|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
344836|NCT00343863|E2|Reported Event|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344837|NCT00343863|E1|Reported Event|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
344838|NCT00343889|B3|Baseline|Total|Total of all reporting groups
344839|NCT00343889|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
344840|NCT00343889|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
344841|NCT00343889|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
344842|NCT00343889|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
344936|NCT00333619|B3|Baseline|Total|Total of all reporting groups
345054|NCT00333814|E2|Reported Event|Dexamethasone 700 µg|Dexamethasone 700 µg
344843|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
344844|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
344845|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
344846|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
344847|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
344848|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
344849|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
344850|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
344851|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
344852|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
344853|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
344854|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
344855|NCT00343889|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
344856|NCT00343889|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
344857|NCT00343915|B3|Baseline|Total|Total of all reporting groups
344858|NCT00343915|B2|Baseline|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
344859|NCT00343915|B1|Baseline|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344860|NCT00343915|P2|Participant Flow|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
344861|NCT00343915|P1|Participant Flow|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344862|NCT00343915|O2|Outcome|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
344863|NCT00343915|O1|Outcome|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344864|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
344865|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344866|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively
344867|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344868|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
344869|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344870|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
344871|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
350627|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
344873|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344874|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
344875|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344876|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively
344877|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344878|NCT00343915|O2|Outcome|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
344879|NCT00343915|O1|Outcome|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344880|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
344881|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344882|NCT00343915|E2|Reported Event|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
344883|NCT00343915|E1|Reported Event|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
344884|NCT00344019|B4|Baseline|Total|Total of all reporting groups
344885|NCT00344019|B3|Baseline|Screening|# patients who signed consent form prior to angiography. 74 did not continue, 23 completed the study. It is believed that most of the 74 did not continue due to the fact that no PCI was indicated at time of angiography
344886|NCT00344019|B2|Baseline|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS
Placebo Oral Tablet: placebo pre-PCI for ACS"
344887|NCT00344019|B1|Baseline|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS
Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
344888|NCT00344019|P3|Participant Flow|Screening|Patients that signed consent to participate. Of 97 patients that consented, only 23 completed the study. 74 patients did not continue likely due to no PCI indicated at time of angiogram. Individual subject data no longer available.
344889|NCT00344019|P2|Participant Flow|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS
Placebo Oral Tablet: placebo pre-PCI for ACS"
344890|NCT00344019|P1|Participant Flow|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS
Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
344891|NCT00344019|O2|Outcome|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS
Placebo Oral Tablet: placebo pre-PCI for ACS"
344892|NCT00344019|O1|Outcome|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS
Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
344893|NCT00344019|E3|Reported Event|Screening|97 patients screened 23 patients completed study in 1:1 randomization scheme. Randomization assignment not known. Data no longer available. No data analyzed
344894|NCT00344019|E2|Reported Event|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS
Placebo Oral Tablet: placebo pre-PCI for ACS"
344895|NCT00344019|E1|Reported Event|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS
Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
344896|NCT00344032|B3|Baseline|Total|Total of all reporting groups
344897|NCT00344032|B2|Baseline|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
344898|NCT00344032|B1|Baseline|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
344899|NCT00344032|P2|Participant Flow|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
344900|NCT00344032|P1|Participant Flow|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
344901|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
344902|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
344903|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
344904|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
344905|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
344906|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
344907|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
344908|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
344909|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
344910|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
344911|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
344912|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
344913|NCT00344032|E2|Reported Event|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
344914|NCT00344032|E1|Reported Event|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
344915|NCT00344175|B3|Baseline|Total|Total of all reporting groups
344916|NCT00344175|B2|Baseline|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
344917|NCT00344175|B1|Baseline|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
344918|NCT00344175|P2|Participant Flow|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
344919|NCT00344175|P1|Participant Flow|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
344922|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
344923|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
344924|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
344925|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
344926|NCT00344175|E2|Reported Event|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
344927|NCT00344175|E1|Reported Event|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
344928|NCT00333437|B1|Baseline|Treatment|Study subjects receive standard mycophenolate dosing.
344929|NCT00333437|P1|Participant Flow|Single-group Study Treatment|Study subjects receive standard mycophenolate dosing 2 grams/day.
344930|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
344931|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
344932|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
344933|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing 2 grams/day.
344934|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
345044|NCT00333814|O3|Outcome|Sham|Sham
344937|NCT00333619|B2|Baseline|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
344938|NCT00333619|B1|Baseline|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
344939|NCT00333619|P2|Participant Flow|Active Control|Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
344940|NCT00333619|P1|Participant Flow|Nonpharmacological Sleep Intervention|The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
344941|NCT00333619|O2|Outcome|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
344942|NCT00333619|O1|Outcome|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
344943|NCT00333619|O2|Outcome|Active Control|Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
344944|NCT00333619|O1|Outcome|Nonpharmacological Sleep Intervention|The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
344945|NCT00333619|E2|Reported Event|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
344946|NCT00333619|E1|Reported Event|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
344947|NCT00333710|B4|Baseline|Total|Total of all reporting groups
344948|NCT00333710|B3|Baseline|Control Condition/Treatment as Usual|"Control condition/treatment as usual.
No active treatment"
344949|NCT00333710|B2|Baseline|Individual Telephone Contact|"Individual telephone contact treatment
Telehealth Intervention: Individual telephone contact with educational and goal setting components"
344950|NCT00333710|B1|Baseline|Individual Face-to-face Contact|"Individual face-to-face contact treatment
Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
344951|NCT00333710|P3|Participant Flow|Control Condition/Treatment as Usual|Control condition/treatment as usual
344952|NCT00333710|P2|Participant Flow|Individual Telephone Contact|"Individual telephone contact treatment
Telehealth Intervention: Individual telephone contact with educational and goal setting components"
344953|NCT00333710|P1|Participant Flow|Individual Face-to-face Contact|"Individual face-to-face contact treatment
Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
344954|NCT00333710|O3|Outcome|Control Condition/Treatment as Usual|Control condition/treatment as usual
345013|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344955|NCT00333710|O2|Outcome|Individual Telephone Contact|"Individual telephone contact treatment
Telehealth Intervention: Individual telephone contact with educational and goal setting components"
344956|NCT00333710|O1|Outcome|Individual Face-to-face Contact|"Individual face-to-face contact treatment
Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
344957|NCT00333710|E3|Reported Event|Control Condition/Treatment as Usual|Control condition/treatment as usual
344958|NCT00333710|E2|Reported Event|Individual Telephone Contact|"Individual telephone contact treatment
Telehealth Intervention: Individual telephone contact with educational and goal setting components"
344959|NCT00333710|E1|Reported Event|Individual Face-to-face Contact|"Individual face-to-face contact treatment
Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
344960|NCT00333762|B1|Baseline|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs
Smart Wheelchair Component System (SWCS) :
Smart Power Assistance Module (SPAM) :"
344961|NCT00333762|P1|Participant Flow|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs
Smart Wheelchair Component System (SWCS) :
Smart Power Assistance Module (SPAM) :"
344962|NCT00333762|O1|Outcome|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs
Smart Wheelchair Component System (SWCS) :
Smart Power Assistance Module (SPAM) :"
344963|NCT00333762|E1|Reported Event|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs
Smart Wheelchair Component System (SWCS) :
Smart Power Assistance Module (SPAM) :"
344964|NCT00333775|B4|Baseline|Total|Total of all reporting groups
344965|NCT00333775|B3|Baseline|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344966|NCT00333775|B2|Baseline|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344967|NCT00333775|B1|Baseline|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344968|NCT00333775|P3|Participant Flow|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344969|NCT00333775|P2|Participant Flow|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344970|NCT00333775|P1|Participant Flow|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344971|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344972|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344973|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344974|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344975|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344976|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344977|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344978|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
345014|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344979|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344980|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344981|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344982|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
345045|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
345046|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
344983|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344984|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344985|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344986|NCT00333775|E3|Reported Event|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344987|NCT00333775|E2|Reported Event|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344988|NCT00333775|E1|Reported Event|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
344989|NCT00333788|B1|Baseline|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344990|NCT00333788|P1|Participant Flow|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344991|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344992|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344993|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344994|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344995|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344996|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344997|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344998|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
344999|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345000|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345001|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345002|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345003|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345004|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345005|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345006|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345007|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345008|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345009|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345010|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345011|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345012|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
350628|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
345015|NCT00333788|E1|Reported Event|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
345016|NCT00333801|B3|Baseline|Total|Total of all reporting groups
345017|NCT00333801|B2|Baseline|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
345018|NCT00333801|B1|Baseline|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
345019|NCT00333801|P2|Participant Flow|Individual Placement and Support (IPS)|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
345047|NCT00333814|O3|Outcome|Sham|Sham
345020|NCT00333801|P1|Participant Flow|Vocational Rehabilitation Program (VRP)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist
345021|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
345022|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
345023|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
345024|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
345025|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
345026|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
345027|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
345028|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
345029|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
345030|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
345031|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
345032|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
345033|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
345034|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
345035|NCT00333801|E2|Reported Event|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
345036|NCT00333801|E1|Reported Event|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
345037|NCT00333814|B4|Baseline|Total|Total of all reporting groups
345038|NCT00333814|B3|Baseline|Sham|Sham
345039|NCT00333814|B2|Baseline|Dexamethasone 700 µg|Dexamethasone 700 µg
345040|NCT00333814|B1|Baseline|Dexamethasone 350 µg|Dexamethasone 350 µg
345041|NCT00333814|P3|Participant Flow|Sham|Sham
345042|NCT00333814|P2|Participant Flow|Dexamethasone 700 µg|Dexamethasone 700 µg
345043|NCT00333814|P1|Participant Flow|Dexamethasone 350 µg|Dexamethasone 350 µg
345055|NCT00333814|E1|Reported Event|Dexamethasone 350 µg|Dexamethasone 350 µg
345056|NCT00333840|B3|Baseline|Total|Total of all reporting groups
345057|NCT00333840|B2|Baseline|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (CSI151). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
345058|NCT00333840|B1|Baseline|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
345059|NCT00333840|P4|Participant Flow|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
345060|NCT00333840|P3|Participant Flow|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
345061|NCT00333840|P2|Participant Flow|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
345062|NCT00333840|P1|Participant Flow|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
345063|NCT00333840|O1|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
345092|NCT00333866|P3|Participant Flow|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345093|NCT00333866|P2|Participant Flow|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
350629|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
345064|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
345065|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
345066|NCT00333840|O2|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
345079|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
345067|NCT00333840|O1|Outcome|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 mu/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injection for 10 days every month in the second-line treatment period.
345068|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
345069|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
345070|NCT00333840|O2|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
345071|NCT00333840|O1|Outcome|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
345072|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
345073|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
345074|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
345075|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C) in the second-line treatment period. Maximum study duration was 11.5 years.
345094|NCT00333866|P1|Participant Flow|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345076|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
345077|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
345078|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (CSI151). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
345080|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
345081|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
345082|NCT00333840|E4|Reported Event|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
345083|NCT00333840|E3|Reported Event|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
345084|NCT00333840|E2|Reported Event|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
345085|NCT00333840|E1|Reported Event|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C) in the second-line treatment period. Maximum study duration was 11.5 years.
345086|NCT00333866|B5|Baseline|Total|Total of all reporting groups
345087|NCT00333866|B4|Baseline|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345088|NCT00333866|B3|Baseline|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345089|NCT00333866|B2|Baseline|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345090|NCT00333866|B1|Baseline|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345091|NCT00333866|P4|Participant Flow|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345095|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345096|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345097|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345098|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345099|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345100|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345101|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345102|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345170|NCT00333983|P2|Participant Flow|Planar + Vertical Robot|Robot-assisted planar and robot-assisted vertical reaching x 60 minutes
345171|NCT00333983|P1|Participant Flow|Planar Robot|Robot-assisted planar reaching x 60 minutes
345103|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345104|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345105|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345106|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345107|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345108|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345109|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345110|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345111|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345112|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345113|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345114|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345115|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345116|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345117|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345118|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345119|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345120|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345121|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345122|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345152|NCT00333879|P1|Participant Flow|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
345123|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345124|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345125|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345126|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345127|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345128|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345129|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345130|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345131|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345132|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345133|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345134|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345135|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345136|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345137|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345138|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345139|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345140|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345141|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345142|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345143|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345144|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345145|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345146|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345147|NCT00333866|E4|Reported Event|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
345148|NCT00333866|E3|Reported Event|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
345149|NCT00333866|E2|Reported Event|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
345150|NCT00333866|E1|Reported Event|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
345151|NCT00333879|B1|Baseline|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
345153|NCT00333879|O1|Outcome|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
345154|NCT00333879|O1|Outcome|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
345155|NCT00333879|E1|Reported Event|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
345156|NCT00333970|B3|Baseline|Total|Total of all reporting groups
345157|NCT00333970|B2|Baseline|Arm 2|treatment as usual
345158|NCT00333970|B1|Baseline|Arm 1|"cognitive remediation
cognitive remediation: individual cognitive training"
345159|NCT00333970|P2|Participant Flow|Arm 2|treatment as usual
345160|NCT00333970|P1|Participant Flow|Arm 1|"cognitive remediation
cognitive remediation: individual cognitive training"
345161|NCT00333970|O2|Outcome|Arm 2|treatment as usual
345162|NCT00333970|O1|Outcome|Arm 1|"cognitive remediation
cognitive remediation: individual cognitive training"
345163|NCT00333970|E2|Reported Event|Arm 2|treatment as usual
345164|NCT00333970|E1|Reported Event|Arm 1|"cognitive remediation
cognitive remediation: individual cognitive training"
345165|NCT00333983|B4|Baseline|Total|Total of all reporting groups
345166|NCT00333983|B3|Baseline|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
345167|NCT00333983|B2|Baseline|Planar + Vertical Robot|Robot-assisted planar and robot-assisted vertical reaching x 60 minutes.
345168|NCT00333983|B1|Baseline|Planar Robot|Robot-assisted planar reaching x 60 minutes.
345169|NCT00333983|P3|Participant Flow|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activites, range of motion and arm ergometer x 60 minutes.
345172|NCT00333983|O3|Outcome|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
345173|NCT00333983|O2|Outcome|Planar + Vertical|Planar + Vertical Robot Exercise x 60 minutes.
345174|NCT00333983|O1|Outcome|Planar Robot|Planar Robot Exercise x 60 minutes.
345175|NCT00333983|E3|Reported Event|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion and arm ergometer training.
345176|NCT00333983|E2|Reported Event|Planar + Vertical Robot|Planar + Vertical Robot Exercise Group
345177|NCT00333983|E1|Reported Event|Planar Robot|Planar Robot Exercise Group
345178|NCT00344305|B3|Baseline|Total|Total of all reporting groups
345179|NCT00344305|B2|Baseline|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345180|NCT00344305|B1|Baseline|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345181|NCT00344305|P2|Participant Flow|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345182|NCT00344305|P1|Participant Flow|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345183|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345184|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345185|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345186|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345224|NCT00344370|O1|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
345225|NCT00344370|E2|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
345226|NCT00344370|E1|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
345227|NCT00344448|B3|Baseline|Total|Total of all reporting groups
345187|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345188|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345189|NCT00344305|O1|Outcome|All Participants|Participants between 6 to < 60 months age received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345190|NCT00344305|O1|Outcome|All Participants|Participants between 6 to < 60 months age received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345191|NCT00344305|O1|Outcome|All Participants|Participants between 6 to < 60 months age received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345192|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345193|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345194|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345195|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345196|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345197|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345198|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345199|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345200|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345201|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345228|NCT00344448|B2|Baseline|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
345509|NCT00346632|O5|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
345202|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345203|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345204|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345205|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345206|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345207|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345208|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345209|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345210|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345211|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345212|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345213|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345214|NCT00344305|E2|Reported Event|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345215|NCT00344305|E1|Reported Event|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
345216|NCT00344370|B3|Baseline|Total|Total of all reporting groups
345217|NCT00344370|B2|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
345218|NCT00344370|B1|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
345219|NCT00344370|P2|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
345220|NCT00344370|P1|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
345221|NCT00344370|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
345222|NCT00344370|O1|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
345223|NCT00344370|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
345229|NCT00344448|B1|Baseline|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
345230|NCT00344448|P2|Participant Flow|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
345231|NCT00344448|P1|Participant Flow|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
345232|NCT00344448|O2|Outcome|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
345233|NCT00344448|O1|Outcome|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
345234|NCT00344448|E2|Reported Event|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
345235|NCT00344448|E1|Reported Event|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
345236|NCT00344487|B1|Baseline|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mgby mouth twice a day for 48 weeks
345237|NCT00344487|P1|Participant Flow|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mg by mouth twice a day for 48 weeks.
345241|NCT00344500|B2|Baseline|Lifestyle Balance|Weight management education and counseling
345242|NCT00344500|B1|Baseline|Usual Care|Usual Care control group
345243|NCT00344500|P3|Participant Flow|Changeover|Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
345244|NCT00344500|P2|Participant Flow|Lifestyle Balance|"Weight management education and counseling
Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient
Be given a 7% weight loss goal
Be assisted in obtaining a 500 calorie reduction per day
Exercise for at least 30 min/day, at least 5 days a week
Maintain weekly food and exercise diaries
Be quizzed on their knowledge of healthy eating habits and nutrition"
345245|NCT00344500|P1|Participant Flow|Usual Care|Usual Care control group
345246|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
345247|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
345248|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
345249|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
345250|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
345251|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
345252|NCT00344500|E3|Reported Event|Changeover|Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
345253|NCT00344500|E2|Reported Event|Lifestyle Balance|"Weight management education and counseling
Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient
Be given a 7% weight loss goal
Be assisted in obtaining a 500 calorie reduction per day
Exercise for at least 30 min/day, at least 5 days a week
Maintain weekly food and exercise diaries
Be quizzed on their knowledge of healthy eating habits and nutrition"
345254|NCT00344500|E1|Reported Event|Usual Care|Usual Care control group
345255|NCT00345631|B4|Baseline|Total|Total of all reporting groups
345256|NCT00345631|B3|Baseline|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345257|NCT00345631|B2|Baseline|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345258|NCT00345631|B1|Baseline|Roll-In|Roll-In patients were device training patients
345259|NCT00345631|P3|Participant Flow|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345260|NCT00345631|P2|Participant Flow|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345261|NCT00345631|P1|Participant Flow|Roll-In|Roll-In patients were device training patients
345262|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345263|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345264|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
345265|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345344|NCT00345878|B1|Baseline|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
345266|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345267|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
345268|NCT00345631|O3|Outcome|Manual Compression (Not Applicable for Device Success)|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345269|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345270|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
345271|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345272|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345273|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
345274|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345275|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345276|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
345277|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345531|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
345278|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345279|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
345280|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345281|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345282|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
345283|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345284|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345285|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
345286|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345287|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345288|NCT00345631|O1|Outcome|Roll-In|patients were device training patients
345289|NCT00345631|E3|Reported Event|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
345290|NCT00345631|E2|Reported Event|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
345291|NCT00345631|E1|Reported Event|Roll-In|Roll-In patients were device training patients
345292|NCT00345683|B3|Baseline|Total|Total of all reporting groups
345293|NCT00345683|B2|Baseline|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345294|NCT00345683|B1|Baseline|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345295|NCT00345683|P2|Participant Flow|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345296|NCT00345683|P1|Participant Flow|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
350630|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
345297|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345298|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345299|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345300|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345316|NCT00345839|B2|Baseline|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345317|NCT00345839|B1|Baseline|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345301|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345302|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345303|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345304|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345305|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345306|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345307|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345308|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345309|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345310|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345345|NCT00345878|P2|Participant Flow|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
350631|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
345311|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345312|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345313|NCT00345683|E2|Reported Event|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345314|NCT00345683|E1|Reported Event|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
345318|NCT00345839|P2|Participant Flow|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345319|NCT00345839|P1|Participant Flow|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345320|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345321|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345322|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345323|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345324|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345325|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345326|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345327|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345328|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345329|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345330|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345331|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345332|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345333|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345334|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345335|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345336|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345337|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345338|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
345339|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345340|NCT00345839|E2|Reported Event|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
345341|NCT00345839|E1|Reported Event|Placebo|
345342|NCT00345878|B3|Baseline|Total|Total of all reporting groups
345343|NCT00345878|B2|Baseline|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
350632|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
345346|NCT00345878|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
345347|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
345348|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
345349|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
345350|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
345351|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
345352|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
345353|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
345354|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
345355|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
345356|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
345357|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
345358|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
345359|NCT00345878|E2|Reported Event|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
345360|NCT00345878|E1|Reported Event|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
345391|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
345361|NCT00346034|B1|Baseline|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
345362|NCT00346034|P1|Participant Flow|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
345363|NCT00346034|O1|Outcome|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
345364|NCT00346034|O1|Outcome|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
345365|NCT00346034|E1|Reported Event|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
345366|NCT00346151|B1|Baseline|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345367|NCT00346151|P1|Participant Flow|Belatacept|Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
345368|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345369|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345370|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345371|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345372|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345373|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345374|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345375|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345376|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345377|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345378|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345505|NCT00346632|O9|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
345379|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345380|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345381|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345382|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345383|NCT00346151|E1|Reported Event|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
345384|NCT00346216|B4|Baseline|Total|Total of all reporting groups
345385|NCT00346216|B3|Baseline|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
345386|NCT00346216|B2|Baseline|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
345387|NCT00346216|B1|Baseline|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
345388|NCT00346216|P3|Participant Flow|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
345389|NCT00346216|P2|Participant Flow|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
345390|NCT00346216|P1|Participant Flow|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
345392|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
345393|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
345394|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
345395|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
345396|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
345397|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
345398|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
345399|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
345400|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
345401|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
345402|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
345403|NCT00346216|E3|Reported Event|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
345404|NCT00346216|E2|Reported Event|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
345405|NCT00346216|E1|Reported Event|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
345406|NCT00346268|B3|Baseline|Total|Total of all reporting groups
345407|NCT00346268|B2|Baseline|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345408|NCT00346268|B1|Baseline|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345409|NCT00346268|P2|Participant Flow|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345410|NCT00346268|P1|Participant Flow|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345411|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345412|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345413|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345414|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345415|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345416|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345417|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345418|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345419|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
346178|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
345420|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345421|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345422|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345423|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345424|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345425|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345426|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345427|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345428|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345429|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345430|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345431|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345432|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345433|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345506|NCT00346632|O8|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
345507|NCT00346632|O7|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
345434|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345435|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345436|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345437|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345438|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345439|NCT00346268|E2|Reported Event|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345526|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
345527|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
345528|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
345440|NCT00346268|E1|Reported Event|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
345441|NCT00346333|B3|Baseline|Total|Total of all reporting groups
345442|NCT00346333|B2|Baseline|Lutein Plus Vitamin A|12mg Lutein plus 15,000IU Vitamin A palmitate daily
345443|NCT00346333|B1|Baseline|Control Plus Vitamin A|cornstarch control plus 15,000IU Vitamin A palmitate daily
345444|NCT00346333|P2|Participant Flow|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
345445|NCT00346333|P1|Participant Flow|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
345446|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
345447|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
345448|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
345449|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
345450|NCT00346333|O2|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
345451|NCT00346333|O1|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
345452|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
345453|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
345454|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
345455|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
345456|NCT00346333|E2|Reported Event|Lutein Plus Vitamin A|12mg Lutein plus 15,000IU Vitamin A daily.
345457|NCT00346333|E1|Reported Event|Control Plus Vitamin A|Daily intake of cornstarch control plus 15,000IU Vitamin A palmitate
345458|NCT00346398|B3|Baseline|Total|Total of all reporting groups
345459|NCT00346398|B2|Baseline|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345460|NCT00346398|B1|Baseline|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345461|NCT00346398|P2|Participant Flow|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345462|NCT00346398|P1|Participant Flow|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345463|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345464|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345508|NCT00346632|O6|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
345465|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345466|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345467|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345468|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345529|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
345530|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
346179|NCT00337571|O1|Outcome|Placebo|
345469|NCT00346398|E2|Reported Event|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345470|NCT00346398|E1|Reported Event|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
345471|NCT00346476|B1|Baseline|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
345472|NCT00346476|P1|Participant Flow|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
345473|NCT00346476|O1|Outcome|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
345474|NCT00346476|O1|Outcome|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
345475|NCT00346476|E1|Reported Event|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
345476|NCT00346632|B3|Baseline|Total|Total of all reporting groups
345477|NCT00346632|B2|Baseline|Arm B: KW-2449 28-day Regimen|Sequential ascending oral doses of KW-2449 given for 28-day cycles
345478|NCT00346632|B1|Baseline|Arm A: KW-2449 14-day Regimen|Sequential ascending oral doses of KW-2449 given for 14-day cycles
345479|NCT00346632|P10|Participant Flow|100 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
345480|NCT00346632|P9|Participant Flow|50 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
345481|NCT00346632|P8|Participant Flow|25 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
345482|NCT00346632|P7|Participant Flow|500 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
345483|NCT00346632|P6|Participant Flow|400 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
345484|NCT00346632|P5|Participant Flow|300 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
345485|NCT00346632|P4|Participant Flow|200 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
345486|NCT00346632|P3|Participant Flow|100 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
345487|NCT00346632|P2|Participant Flow|50 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
345488|NCT00346632|P1|Participant Flow|25 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
345489|NCT00346632|O12|Outcome|Arm B - Total|Total Patients in Treatment Arm B
345490|NCT00346632|O11|Outcome|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
345491|NCT00346632|O10|Outcome|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
345492|NCT00346632|O9|Outcome|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
345493|NCT00346632|O8|Outcome|Arm A - Total|Total Patients in Treatment Arm A
345494|NCT00346632|O7|Outcome|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
345495|NCT00346632|O6|Outcome|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
345496|NCT00346632|O5|Outcome|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
345497|NCT00346632|O4|Outcome|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
345498|NCT00346632|O3|Outcome|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
345499|NCT00346632|O2|Outcome|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
345500|NCT00346632|O1|Outcome|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
345501|NCT00346632|O13|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
345502|NCT00346632|O12|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
345503|NCT00346632|O11|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
345504|NCT00346632|O10|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
345510|NCT00346632|O4|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
345511|NCT00346632|O3|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
345512|NCT00346632|O2|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
345513|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
345514|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
345515|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
345516|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
345517|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
345518|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
345519|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
345520|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
345521|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
345522|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
345523|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
345524|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
345525|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
345532|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
345533|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
345534|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
345535|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
345536|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
345537|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
345538|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
345539|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
345540|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
345541|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
345542|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
345543|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
345544|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
345545|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
345546|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
345547|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
345548|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
345549|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
345550|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
345551|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
345552|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
345553|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
345554|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
345555|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
345556|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
345557|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
345558|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
345559|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
345560|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
345561|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
345562|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
345563|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
345564|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
345565|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
345566|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
345567|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
345568|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
345569|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
345570|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
345571|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
345572|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
345573|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
345574|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
350633|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
345575|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
345576|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
345577|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
345578|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
345579|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
345580|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
345581|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
345582|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
345583|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
345584|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
345585|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
345586|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
345587|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
345588|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
345589|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
345590|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
345591|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
345592|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
345593|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
345594|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
345595|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
345596|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
345597|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
345598|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
345599|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
345600|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
345601|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
345602|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
345603|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
345604|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
345605|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
345606|NCT00346632|O12|Outcome|Arm B - Total|Total Patients in Treatment Arm B
345607|NCT00346632|O11|Outcome|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
345608|NCT00346632|O10|Outcome|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
345609|NCT00346632|O9|Outcome|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
345610|NCT00346632|O8|Outcome|Arm A - Total|Total Patients in Treatment Arm A
345611|NCT00346632|O7|Outcome|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
345612|NCT00346632|O6|Outcome|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
345613|NCT00346632|O5|Outcome|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
345614|NCT00346632|O4|Outcome|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
345615|NCT00346632|O3|Outcome|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
345616|NCT00346632|O2|Outcome|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
345617|NCT00346632|O1|Outcome|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
345618|NCT00346632|E12|Reported Event|Arm B - Total|Total Patients in Treatment Arm B
345619|NCT00346632|E11|Reported Event|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
345620|NCT00346632|E10|Reported Event|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
345621|NCT00346632|E9|Reported Event|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
345622|NCT00346632|E8|Reported Event|Arm A - Total|Total Patients in Treatment Arm A
345623|NCT00346632|E7|Reported Event|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
345624|NCT00346632|E6|Reported Event|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
345625|NCT00346632|E5|Reported Event|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
345626|NCT00346632|E4|Reported Event|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
345627|NCT00346632|E3|Reported Event|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
345628|NCT00346632|E2|Reported Event|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
345629|NCT00346632|E1|Reported Event|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
345630|NCT00346697|B3|Baseline|Total|Total of all reporting groups
345631|NCT00346697|B2|Baseline|Placebo|Corn oil placebo, plus dietary counselling
345632|NCT00346697|B1|Baseline|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345633|NCT00346697|P2|Participant Flow|Placebo|Corn oil placebo, plus dietary counselling
345634|NCT00346697|P1|Participant Flow|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345635|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
345636|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345637|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
345638|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345639|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
345640|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345641|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
350634|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
345642|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345643|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
345644|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345645|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
345646|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345647|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
345648|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345649|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
345650|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345651|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
345652|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345653|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345654|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345655|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345656|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345657|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345658|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345659|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345660|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345661|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345662|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345663|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
345664|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
345665|NCT00346697|E2|Reported Event|Placebo|"Corn oil placebo, plus dietary counselling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345666|NCT00346697|E1|Reported Event|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling
Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
345667|NCT00346905|B1|Baseline|Group 1|Patients experiencing moderate GERD
345668|NCT00346905|P1|Participant Flow|Group 1|Patients that are GERD responsive and requiring daily PPI therapy
345669|NCT00346905|O1|Outcome|Enteryx Treatment|"Those receiving Enteryx treatment
Enteryx"
345670|NCT00346905|E1|Reported Event|Group 1 - Single Arm|Those experiencing GERD
345671|NCT00347009|B1|Baseline|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345672|NCT00347009|P1|Participant Flow|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345673|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345674|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345675|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345676|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345677|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345678|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345679|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345680|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345681|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345682|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345683|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345684|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345685|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345686|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345687|NCT00347009|E1|Reported Event|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
345688|NCT00347022|B3|Baseline|Total|Total of all reporting groups
345689|NCT00347022|B2|Baseline|Visipaque|Patient will be injected with Visipaque 270
345690|NCT00347022|B1|Baseline|Xenetix|Patient will be injected with Xenetix 300
345691|NCT00347022|P2|Participant Flow|Visipaque|Patient will receive one injection of Visipaque 270
345692|NCT00347022|P1|Participant Flow|Xenetix|Patient will receive one injection of Xenetix 300
345693|NCT00347022|O2|Outcome|Visipaque|Patient will receive one injection of Visipaque 270
345694|NCT00347022|O1|Outcome|Xenetix|Patient will receive one injection of Xenetix 300
345695|NCT00347022|E2|Reported Event|Vispaque|Patient will be injected with Visipaque 270
345696|NCT00347022|E1|Reported Event|Xenetix|Patient will be injected with Xenetix 300
345697|NCT00347269|B3|Baseline|Total|Total of all reporting groups
345698|NCT00347269|B2|Baseline|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)
Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
345734|NCT00347360|P7|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345699|NCT00347269|B1|Baseline|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--
CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.
Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose
Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
345700|NCT00347269|P2|Participant Flow|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)
Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
345701|NCT00347269|P1|Participant Flow|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--
CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.
Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose
Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
345702|NCT00347269|O2|Outcome|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)
Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
345750|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345751|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345752|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345753|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
345703|NCT00347269|O1|Outcome|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--
CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.
Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose
Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
345704|NCT00347269|E2|Reported Event|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)
Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
345705|NCT00347269|E1|Reported Event|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--
CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.
Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose
Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
345706|NCT00347308|B1|Baseline|Group 1|All patients entered into the study
345707|NCT00347308|P1|Participant Flow|Group 1|All patients entered into the study
345708|NCT00347308|O1|Outcome|Group 1|All patients entered into the study
345709|NCT00347308|E1|Reported Event|Group 1|All patients entered into the study
345710|NCT00347360|B16|Baseline|Total|Total of all reporting groups
345711|NCT00347360|B15|Baseline|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345712|NCT00347360|B14|Baseline|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345713|NCT00347360|B13|Baseline|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345714|NCT00347360|B12|Baseline|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345715|NCT00347360|B11|Baseline|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345716|NCT00347360|B10|Baseline|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345717|NCT00347360|B9|Baseline|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345718|NCT00347360|B8|Baseline|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345719|NCT00347360|B7|Baseline|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345720|NCT00347360|B6|Baseline|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345721|NCT00347360|B5|Baseline|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345722|NCT00347360|B4|Baseline|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345723|NCT00347360|B3|Baseline|Lisinopril 40|lisinopril 40 mg once daily
345724|NCT00347360|B2|Baseline|Lisinopril 20|lisinopril 20 mg once daily
345725|NCT00347360|B1|Baseline|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345726|NCT00347360|P15|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345727|NCT00347360|P14|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345728|NCT00347360|P13|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345729|NCT00347360|P12|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345730|NCT00347360|P11|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345731|NCT00347360|P10|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345732|NCT00347360|P9|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345733|NCT00347360|P8|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345735|NCT00347360|P6|Participant Flow|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345736|NCT00347360|P5|Participant Flow|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345737|NCT00347360|P4|Participant Flow|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345738|NCT00347360|P3|Participant Flow|Lisinopril 40|lisinopril 40 mg once daily
345739|NCT00347360|P2|Participant Flow|Lisinopril 20|lisinopril 20 mg once daily
345740|NCT00347360|P1|Participant Flow|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345741|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345742|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345743|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345744|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345745|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345746|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345747|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345748|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345749|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345755|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345756|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345757|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345758|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345759|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345760|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345761|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345762|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345763|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345764|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345765|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345766|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345767|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345768|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
345769|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
345770|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345771|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345772|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345773|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345774|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345775|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345776|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345777|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345778|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345779|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345780|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345781|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345782|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345783|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
345784|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
345785|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345786|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345787|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345788|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345789|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345790|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345791|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
346608|NCT00340379|P1|Participant Flow|Ziprasidone|Target dosage of 120-160mg/day based on tolerance.
345792|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345793|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345794|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345795|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345796|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345797|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345798|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
345799|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
345800|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345801|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345802|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345803|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345804|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345805|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345806|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345807|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345808|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345809|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345810|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345811|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345812|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345813|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
345814|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
345815|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345816|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345817|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345818|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345819|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345820|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345821|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345822|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345823|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345824|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345825|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345826|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345827|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345828|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
345829|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
345830|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345831|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345832|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345833|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345834|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345835|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345836|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345837|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345838|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345839|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345840|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345841|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345842|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345843|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
345844|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
345845|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345846|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345847|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345848|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345849|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345850|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345851|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345852|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345853|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345854|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345855|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345856|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345857|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345858|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
345859|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
345860|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345861|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345862|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345863|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345864|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345865|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345866|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345867|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345868|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345869|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345870|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345871|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345872|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345873|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
345874|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
345875|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345876|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345877|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345878|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345879|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345880|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345881|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345882|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345883|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345884|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345885|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345886|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345887|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345888|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
345889|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
345890|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345891|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345892|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345893|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345894|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345895|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345896|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345897|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345898|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345899|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345900|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345901|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345902|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345903|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
345904|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
345905|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345906|NCT00347360|E15|Reported Event|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
345907|NCT00347360|E14|Reported Event|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
345908|NCT00347360|E13|Reported Event|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
345909|NCT00347360|E12|Reported Event|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
345910|NCT00347360|E11|Reported Event|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
345911|NCT00347360|E10|Reported Event|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
345912|NCT00347360|E9|Reported Event|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
345913|NCT00347360|E8|Reported Event|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
345914|NCT00347360|E7|Reported Event|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
345915|NCT00347360|E6|Reported Event|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
345916|NCT00347360|E5|Reported Event|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
345917|NCT00347360|E4|Reported Event|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
345918|NCT00347360|E3|Reported Event|Lisinopril 40|lisinopril 40 mg once daily
345919|NCT00347360|E2|Reported Event|Lisinopril 20|lisinopril 20 mg once daily
345920|NCT00347360|E1|Reported Event|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
345921|NCT00347438|B1|Baseline|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
345922|NCT00347438|P1|Participant Flow|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
345923|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
345924|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
345925|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
345926|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
345927|NCT00347438|E1|Reported Event|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
345928|NCT00347776|B4|Baseline|Total|Total of all reporting groups
345929|NCT00347776|B3|Baseline|Intervention2|Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
345930|NCT00347776|B2|Baseline|Intervention1|Oral azithromycin,single 1g dose to subject Antibiotic : Oral azithromycin (1 g)
345931|NCT00347776|B1|Baseline|Control|Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks
345932|NCT00347776|P3|Participant Flow|Intervention 2|Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
345933|NCT00347776|P2|Participant Flow|Intervention 1|Oral azithromycin,single 1g dose to subject only Antibiotic : Oral azithromycin (1 g)
345934|NCT00347776|P1|Participant Flow|Control|Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks
345935|NCT00347776|O2|Outcome|Intervention|"The two azithromycin groups combined
Antibiotic: Oral Azithromycin"
345936|NCT00347776|O1|Outcome|Control|"Topical tetracycline
Antibiotic:Topical tetracycline"
345937|NCT00347776|O2|Outcome|Intervention|"The two azithromycin groups combined
Antibiotic: Oral Azithromycin"
345938|NCT00347776|O1|Outcome|Control|"Topical tetracycline
Antibiotic:Topical tetracycline"
345939|NCT00347776|O2|Outcome|Intervention2|Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
345940|NCT00347776|O1|Outcome|Intervention1|Oral azithromycin,single 1g dose to subject Antibiotic : Oral azithromycin (1 g)
345941|NCT00347776|O2|Outcome|Intervention|"The two azithromycin groups combined
Antibiotic: Oral Azithromycin"
345942|NCT00347776|O1|Outcome|Control|"Topical tetracycline
Antibiotic:Topical tetracycline"
345943|NCT00347776|E2|Reported Event|Intervention|"The two azithromycin groups combined
Antibiotic: Oral Azithromycin"
345944|NCT00347776|E1|Reported Event|Control|"Topical tetracycline
Antibiotic:Topical tetracycline"
345945|NCT00347919|B4|Baseline|Total|Total of all reporting groups
345946|NCT00347919|B3|Baseline|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
345947|NCT00347919|B2|Baseline|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
345948|NCT00347919|B1|Baseline|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
345949|NCT00347919|P3|Participant Flow|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
345950|NCT00347919|P2|Participant Flow|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
345951|NCT00347919|P1|Participant Flow|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
345952|NCT00347919|O1|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
345953|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
345954|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
345955|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
345956|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/ Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
345957|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
345958|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
345959|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
346609|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
345960|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
345961|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
345962|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
345963|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
345964|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
345965|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
345966|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
345967|NCT00347919|E3|Reported Event|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
345968|NCT00347919|E2|Reported Event|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
345969|NCT00347919|E1|Reported Event|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
345970|NCT00347932|B3|Baseline|Total|Total of all reporting groups
345971|NCT00347932|B2|Baseline|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345972|NCT00347932|B1|Baseline|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345973|NCT00347932|P2|Participant Flow|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345974|NCT00347932|P1|Participant Flow|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345975|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345976|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345977|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345978|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345979|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345980|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345981|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345982|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345983|NCT00347932|E2|Reported Event|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345984|NCT00347932|E1|Reported Event|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
345985|NCT00347958|B1|Baseline|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
345986|NCT00347958|P1|Participant Flow|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
345987|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
345988|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
345989|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
345990|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
345991|NCT00347958|E1|Reported Event|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
345992|NCT00336973|B1|Baseline|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
345993|NCT00336973|P1|Participant Flow|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
345994|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
345995|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
345996|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
345997|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
345998|NCT00337077|B4|Baseline|Total|Total of all reporting groups
345999|NCT00337077|B3|Baseline|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346610|NCT00340379|O1|Outcome|Ziprasidone|
346611|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
346000|NCT00337077|B2|Baseline|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346001|NCT00337077|B1|Baseline|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346002|NCT00337077|P3|Participant Flow|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346003|NCT00337077|P2|Participant Flow|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346004|NCT00337077|P1|Participant Flow|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346005|NCT00337077|O3|Outcome|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346006|NCT00337077|O2|Outcome|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346007|NCT00337077|O1|Outcome|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346097|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
346008|NCT00337077|O3|Outcome|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346009|NCT00337077|O2|Outcome|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346010|NCT00337077|O1|Outcome|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
346011|NCT00337077|E1|Reported Event|Eribulin Mesylate|All treated patients are evaluated for toxicities except for one patient who died soon after starting treatment and was not assessed for toxicity.
346012|NCT00337103|B3|Baseline|Total|Total of all reporting groups
346013|NCT00337103|B2|Baseline|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
346014|NCT00337103|B1|Baseline|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
346015|NCT00337103|P2|Participant Flow|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
346016|NCT00337103|P1|Participant Flow|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
346017|NCT00337103|O2|Outcome|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
346018|NCT00337103|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
346019|NCT00337103|O2|Outcome|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
346020|NCT00337103|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
346021|NCT00337103|E2|Reported Event|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
346022|NCT00337103|E1|Reported Event|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
346023|NCT00337129|B1|Baseline|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
346024|NCT00337129|P1|Participant Flow|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
346025|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
346026|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
346027|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
346028|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
346029|NCT00337129|E1|Reported Event|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle. Includes only patients who received drug.
346030|NCT00337168|B1|Baseline|Induction|
346031|NCT00337168|P1|Participant Flow|Induction|Clofarabine (40 mg per meters squared per day) and cytarabine (1 g per meters squared per day)
346032|NCT00337168|O1|Outcome|Induction|Up to two induction cycles with clofarabine and cytarabine
346033|NCT00337168|O1|Outcome|Induction|
346034|NCT00337168|O1|Outcome|Induction|
346035|NCT00337168|O1|Outcome|Induction|
346036|NCT00337168|E1|Reported Event|Induction|Up to two induction cycles with clofarabine and cytarabine
346037|NCT00337194|B3|Baseline|Total|Total of all reporting groups
346078|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
346079|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
346612|NCT00340379|O1|Outcome|Ziprasidone|
346038|NCT00337194|B2|Baseline|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346039|NCT00337194|B1|Baseline|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346098|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
346099|NCT00337350|E2|Reported Event|Placebo|matched placebo for rosiglitazone 4mg/day
346100|NCT00337350|E1|Reported Event|Rosiglitazone|rosiglitazone 4mg/day
346101|NCT00337428|B3|Baseline|Total|Total of all reporting groups
346102|NCT00337428|B2|Baseline|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346180|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
346181|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
346040|NCT00337194|P2|Participant Flow|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346041|NCT00337194|P1|Participant Flow|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346042|NCT00337194|O2|Outcome|Non-responders|Subset of patients who did not achieve an overall response, as defined in primary outcome measure 1
346043|NCT00337194|O1|Outcome|Responders|Subset of patients who achieved an overall response, as describer in primary outcome measure 1.
346044|NCT00337194|O2|Outcome|Non-responders|Subset of patients who did not achieve an overall response, as defined in primary outcome measure 1
346045|NCT00337194|O1|Outcome|Responders|Subset of patients who achieved an overall response, as describer in primary outcome measure 1.
346046|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346047|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346048|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346049|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346080|NCT00337272|E2|Reported Event|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
346081|NCT00337272|E1|Reported Event|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
346082|NCT00337285|B1|Baseline|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
346050|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346051|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346052|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346053|NCT00337194|E2|Reported Event|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
placebo: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharma"
346054|NCT00337194|E1|Reported Event|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
monoclonal antibody SGN-30: Given IV
vinorelbine tartrate: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
gemcitabine hydrochloride: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
346055|NCT00337207|B1|Baseline|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
346056|NCT00337207|P1|Participant Flow|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
346057|NCT00337207|O1|Outcome|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
346058|NCT00337207|E1|Reported Event|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
346059|NCT00337272|B3|Baseline|Total|Total of all reporting groups
346060|NCT00337272|B2|Baseline|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
346061|NCT00337272|B1|Baseline|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
346062|NCT00337272|P2|Participant Flow|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
346063|NCT00337272|P1|Participant Flow|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
346064|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
346065|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
346066|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
346067|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
346068|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
346069|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
346070|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
346071|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
346072|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
346073|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
346074|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
346075|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
346076|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
346077|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
346613|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
346083|NCT00337285|P1|Participant Flow|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
346084|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
346085|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
346086|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
346087|NCT00337285|E1|Reported Event|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
346088|NCT00337350|B3|Baseline|Total|Total of all reporting groups
346089|NCT00337350|B2|Baseline|Placebo|matched placebo for rosiglitazone 4mg/day
346090|NCT00337350|B1|Baseline|Rosiglitazone|rosiglitazone 4mg/day
346091|NCT00337350|P2|Participant Flow|Placebo|matched placebo for rosiglitazone 4mg/day
346092|NCT00337350|P1|Participant Flow|Rosiglitazone|rosiglitazone 4mg/day
346093|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
346094|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
346095|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
346103|NCT00337428|B1|Baseline|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346104|NCT00337428|P2|Participant Flow|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346105|NCT00337428|P1|Participant Flow|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346106|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346107|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346108|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346109|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346110|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346111|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346112|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346113|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346114|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346115|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346116|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346117|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346118|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346119|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346120|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346121|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346122|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346123|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346614|NCT00340379|O1|Outcome|Ziprasidone|
346615|NCT00340379|E2|Reported Event|Sertraline/Haloperidol|
346124|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346125|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346126|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346127|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346128|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346129|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346130|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346131|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346132|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346133|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346134|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346135|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346136|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346137|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346138|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346139|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346140|NCT00337428|E2|Reported Event|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
346141|NCT00337428|E1|Reported Event|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
346142|NCT00337467|B1|Baseline|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346143|NCT00337467|P1|Participant Flow|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346144|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346145|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346146|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346147|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346148|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346149|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346150|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346151|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346152|NCT00337467|O1|Outcome|Proportion of Participants|Proportion of participants without virologic rebound at the end of interval
346153|NCT00337467|O1|Outcome|Proportion of Participants|Proportion of participants without treatment failure at the end of interval
346154|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346155|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346156|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346157|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346158|NCT00337467|E1|Reported Event|ATV/RTV Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
346159|NCT00337571|B5|Baseline|Total|Total of all reporting groups
346160|NCT00337571|B4|Baseline|Aripiprazole 15 mg|
346161|NCT00337571|B3|Baseline|Aripiprazole 10 mg|
346162|NCT00337571|B2|Baseline|Aripiprazole 5 mg|
346163|NCT00337571|B1|Baseline|Placebo|
346164|NCT00337571|P4|Participant Flow|Aripiprazole 15 mg|
346165|NCT00337571|P3|Participant Flow|Aripiprazole 10 mg|
346166|NCT00337571|P2|Participant Flow|Aripiprazole 5 mg|
346167|NCT00337571|P1|Participant Flow|Placebo|
346168|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
346169|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
346170|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
346171|NCT00337571|O1|Outcome|Placebo|
346172|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
346173|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
346174|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
346175|NCT00337571|O1|Outcome|Placebo|
346176|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
346182|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
346183|NCT00337571|O1|Outcome|Placebo|
346184|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
346185|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
346186|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
346187|NCT00337571|O1|Outcome|Placebo|
346188|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
346189|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
346190|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
346191|NCT00337571|O1|Outcome|Placebo|
346192|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
346193|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
346194|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
346195|NCT00337571|O1|Outcome|Placebo|
346196|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
346197|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
346198|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
346199|NCT00337571|O1|Outcome|Placebo|
346200|NCT00337571|E4|Reported Event|Placebo|
346201|NCT00337571|E3|Reported Event|Aripiprazole 5 mg|
346202|NCT00337571|E2|Reported Event|Aripiprazole 15 mg|
346203|NCT00337571|E1|Reported Event|Aripiprazole 10 mg|
346204|NCT00337610|B3|Baseline|Total|Total of all reporting groups
346205|NCT00337610|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346206|NCT00337610|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346207|NCT00337610|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346208|NCT00337610|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346209|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346210|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346211|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346212|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346213|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346214|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346215|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346216|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346217|NCT00337610|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346218|NCT00337610|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
346219|NCT00337662|B4|Baseline|Total|Total of all reporting groups
346220|NCT00337662|B3|Baseline|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346221|NCT00337662|B2|Baseline|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346222|NCT00337662|B1|Baseline|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346223|NCT00337662|P4|Participant Flow|Risperiodone Open-Label Lead-In|"All patients completed a 2-week open-label risperidone lead-in period. This group contains all patients who started Study Period II.
Risperidone: 2-6 mg, oral, daily"
346224|NCT00337662|P3|Participant Flow|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346225|NCT00337662|P2|Participant Flow|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346226|NCT00337662|P1|Participant Flow|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346227|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346228|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346229|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346230|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346231|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346232|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346233|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346234|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346235|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346236|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346237|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346238|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346239|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346240|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346241|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346242|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346243|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346244|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346245|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346246|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346247|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346248|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346249|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346250|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346251|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346252|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346253|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346254|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346255|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346256|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346257|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346258|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346259|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346260|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346261|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346262|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346263|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346264|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346265|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346266|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346267|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346268|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346269|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346270|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
346271|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346272|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346273|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
346274|NCT00337662|E3|Reported Event|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
346275|NCT00337662|E2|Reported Event|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
346276|NCT00337662|E1|Reported Event|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks.
346277|NCT00337675|B4|Baseline|Total|Total of all reporting groups
346335|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346784|NCT00340834|E5|Reported Event|EXT FTY720 0.5 mg|EXT FTY720 0.5 mg
346278|NCT00337675|B3|Baseline|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346279|NCT00337675|B2|Baseline|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346280|NCT00337675|B1|Baseline|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346281|NCT00337675|P3|Participant Flow|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346282|NCT00337675|P2|Participant Flow|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346283|NCT00337675|P1|Participant Flow|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346284|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346285|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346286|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346287|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346288|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346325|NCT00337818|P2|Participant Flow|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
346289|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346290|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346291|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346292|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346293|NCT00337675|E3|Reported Event|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346785|NCT00340834|E4|Reported Event|EXT FTY720 1.25 mg|EXT FTY720 1.25 mg
346294|NCT00337675|E2|Reported Event|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346295|NCT00337675|E1|Reported Event|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
346296|NCT00337727|B3|Baseline|Total|Total of all reporting groups
346297|NCT00337727|B2|Baseline|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
346298|NCT00337727|B1|Baseline|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
346299|NCT00337727|P2|Participant Flow|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
346300|NCT00337727|P1|Participant Flow|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
346301|NCT00337727|O2|Outcome|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
346302|NCT00337727|O1|Outcome|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
346303|NCT00337727|O2|Outcome|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
346304|NCT00337727|O1|Outcome|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
346305|NCT00337727|E2|Reported Event|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
346306|NCT00337727|E1|Reported Event|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
346307|NCT00337779|B3|Baseline|Total|Total of all reporting groups
346308|NCT00337779|B2|Baseline|Glatiramer Acetate 40 mg|
346309|NCT00337779|B1|Baseline|Glatiramer Acetate 20 mg|
346310|NCT00337779|P2|Participant Flow|Glatiramer Acetate 40 mg|
346311|NCT00337779|P1|Participant Flow|Glatiramer Acetate 20 mg|
346312|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
346313|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
346314|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
346315|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
346316|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
346317|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
346318|NCT00337779|E2|Reported Event|Glatiramer Acetate 40 mg|
346319|NCT00337779|E1|Reported Event|Glatiramer Acetate 20 mg|
346320|NCT00337818|B4|Baseline|Total|Total of all reporting groups
346321|NCT00337818|B3|Baseline|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346322|NCT00337818|B2|Baseline|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
346323|NCT00337818|B1|Baseline|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346324|NCT00337818|P3|Participant Flow|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346394|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
346326|NCT00337818|P1|Participant Flow|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346327|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346328|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
346329|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346330|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346331|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
346332|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346333|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346334|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
346786|NCT00340834|E3|Reported Event|COR Interferon Beta-1a|COR Interferon beta-1a
346336|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346337|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
346338|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346339|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346340|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
346341|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346342|NCT00337818|E3|Reported Event|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346343|NCT00337818|E2|Reported Event|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
346344|NCT00337818|E1|Reported Event|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
346345|NCT00337935|B3|Baseline|Total|Total of all reporting groups
346346|NCT00337935|B2|Baseline|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
346347|NCT00337935|B1|Baseline|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
346348|NCT00337935|P2|Participant Flow|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
346349|NCT00337935|P1|Participant Flow|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
346350|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
346351|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs). Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.
346352|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
346353|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
346354|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
346355|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
346356|NCT00337935|E2|Reported Event|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
346357|NCT00337935|E1|Reported Event|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
346358|NCT00337987|B1|Baseline|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
346359|NCT00337987|P1|Participant Flow|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
346360|NCT00337987|O1|Outcome|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
346361|NCT00337987|O1|Outcome|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
346362|NCT00337987|E1|Reported Event|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
346363|NCT00338039|B1|Baseline|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
346364|NCT00338039|P1|Participant Flow|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 intravenous (IV)/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Grey delivered in 28 fractions.
346405|NCT00338962|B1|Baseline|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day"
346787|NCT00340834|E2|Reported Event|COR FTY720 0.5 mg|COR FTY720 0.5 mg
346365|NCT00338039|O1|Outcome|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
346366|NCT00338039|O1|Outcome|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
346367|NCT00338039|E1|Reported Event|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
346368|NCT00338104|B4|Baseline|Total|Total of all reporting groups
346369|NCT00338104|B3|Baseline|80% Group|Glargine at 80% of insulin drip rate
346370|NCT00338104|B2|Baseline|60% Group|Glargine at 60% of insulin drip rate
346371|NCT00338104|B1|Baseline|40% Group|Glargine at 40% of insulin drip rate
346372|NCT00338104|P3|Participant Flow|80% Group|Glargine at 80% of insulin drip rate
346373|NCT00338104|P2|Participant Flow|60% Group|Glargine at 60% of insulin drip rate
346374|NCT00338104|P1|Participant Flow|40% Group|Glargine at 40% of insulin drip rate
346375|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
346376|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
346377|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
346378|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
346379|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
346380|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
346381|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
346382|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
346383|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
346384|NCT00338286|B3|Baseline|Total|Total of all reporting groups
346385|NCT00338286|B2|Baseline|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
346386|NCT00338286|B1|Baseline|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
346387|NCT00338286|P2|Participant Flow|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
346388|NCT00338286|P1|Participant Flow|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
346389|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
346390|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
346391|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
346392|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
346393|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
346616|NCT00340379|E1|Reported Event|Ziprasidone|
346395|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
346396|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
346397|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
346398|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
346399|NCT00338286|E2|Reported Event|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
346400|NCT00338286|E1|Reported Event|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
346401|NCT00338962|B5|Baseline|Total|Total of all reporting groups
346402|NCT00338962|B4|Baseline|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo"
346403|NCT00338962|B3|Baseline|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day"
346404|NCT00338962|B2|Baseline|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo"
346788|NCT00340834|E1|Reported Event|COR FTY720 1.25 mg|COR FTY720 1.25 mg
346406|NCT00338962|P4|Participant Flow|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo"
346407|NCT00338962|P3|Participant Flow|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day"
346408|NCT00338962|P2|Participant Flow|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo"
346409|NCT00338962|P1|Participant Flow|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day"
346410|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo"
346411|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day"
346412|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo"
346413|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day"
346414|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo"
346415|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day"
346416|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo"
346417|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day"
346418|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo"
346419|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day"
346420|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo"
346421|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day"
346422|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo"
346423|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day"
346617|NCT00340678|B5|Baseline|Total|Total of all reporting groups
347075|NCT00349908|E2|Reported Event|Group 2: Aneurysm Arm|This is the events from the Aneurysm Arm
346424|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo"
346425|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day"
346426|NCT00338962|E4|Reported Event|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo"
346427|NCT00338962|E3|Reported Event|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day"
346428|NCT00338962|E2|Reported Event|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo"
346429|NCT00338962|E1|Reported Event|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day"
346430|NCT00338988|B1|Baseline|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
346431|NCT00338988|P1|Participant Flow|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
346432|NCT00338988|O1|Outcome|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
346433|NCT00338988|E2|Reported Event|Stratum 2: No Prior Therapy|Previously untreated. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14.
346434|NCT00338988|E1|Reported Event|Stratum: 1 Prior Regimen|Received prior therapy. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14.
346435|NCT00339040|B3|Baseline|Total|Total of all reporting groups
346436|NCT00339040|B2|Baseline|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
346437|NCT00339040|B1|Baseline|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
346438|NCT00339040|P2|Participant Flow|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
346439|NCT00339040|P1|Participant Flow|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
346440|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
346441|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
346442|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
346443|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
346444|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
346445|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
346446|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
346447|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
346448|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
346449|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
346450|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
346451|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
346452|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
346453|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
346454|NCT00339040|E2|Reported Event|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
350635|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
346455|NCT00339040|E1|Reported Event|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
346456|NCT00339079|B5|Baseline|Total|Total of all reporting groups
346457|NCT00339079|B4|Baseline|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when administered alone in the other arms.
346458|NCT00339079|B3|Baseline|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter.
346459|NCT00339079|B2|Baseline|Placebo|Patients only received placebo pills
346460|NCT00339079|B1|Baseline|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
346461|NCT00339079|P4|Participant Flow|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
346462|NCT00339079|P3|Participant Flow|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
346463|NCT00339079|P2|Participant Flow|Placebo|Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office
346464|NCT00339079|P1|Participant Flow|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
346465|NCT00339079|O4|Outcome|Combined CBT and Fluoxetine|"Patients arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
Fluoxetine: Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.
Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes wi"
346466|NCT00339079|O3|Outcome|Fluoxetine|"Patients received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
Fluoxetine: Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.
Supportiv"
346467|NCT00339079|O2|Outcome|Placebo|"Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
Supportive Therapy: The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.
Placebo: Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter."
346468|NCT00339079|O1|Outcome|Cognitive Behavioral Therapy (CBT)|"Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length."
346469|NCT00339079|O4|Outcome|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
346470|NCT00339079|O3|Outcome|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
346471|NCT00339079|O2|Outcome|Placebo|Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office
346472|NCT00339079|O1|Outcome|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
346473|NCT00339079|E4|Reported Event|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
346474|NCT00339079|E3|Reported Event|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
346475|NCT00339079|E2|Reported Event|Placebo|"Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
Supportive Therapy: The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.
Placebo: Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter."
346476|NCT00339079|E1|Reported Event|Cognitive Behavioral Therapy (CBT)|"Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length."
346477|NCT00339144|B4|Baseline|Total|Total of all reporting groups
346789|NCT00348283|B3|Baseline|Total|Total of all reporting groups
346478|NCT00339144|B3|Baseline|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346479|NCT00339144|B2|Baseline|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346480|NCT00339144|B1|Baseline|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346481|NCT00339144|P3|Participant Flow|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346482|NCT00339144|P2|Participant Flow|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346483|NCT00339144|P1|Participant Flow|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346484|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346485|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346486|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
347124|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
346487|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346488|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346489|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346624|NCT00340678|P2|Participant Flow|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
346796|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
346797|NCT00348283|O1|Outcome|Placebo|
346798|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
346490|NCT00339144|O1|Outcome|Dasatinib (Total)|Dasatinib(100 mg, 150 mg, 200 mg) was administered once daily via oral route for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose would be escalated to next higher level. If a DLT was observed among one of three treated participants in the first course at a dose level, 3 participants would be additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose might be escalated to next higher dose level.
346491|NCT00339144|O1|Outcome|Dasatinib (Total)|Dasatinib(100 mg, 150 mg, 200 mg) was administered once daily via oral route for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose would be escalated to next higher level. If a DLT was observed among one of three treated participants in the first course at a dose level, 3 participants would be additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose might be escalated to next higher dose level.
346492|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346493|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346494|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346495|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346496|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346497|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346498|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346499|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346500|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346501|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346502|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346503|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346504|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346505|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346506|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346507|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346508|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346509|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346510|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346511|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346588|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346589|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
347076|NCT00349908|E1|Reported Event|Group 1: Atherosclerosis Arm|This is the events from the Atherosclerosis Arm
346512|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346513|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346514|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346515|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346516|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346517|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346518|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346519|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346520|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346521|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346522|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346523|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346590|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346591|NCT00339183|E2|Reported Event|FOLFIRI Alone|Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346618|NCT00340678|B4|Baseline|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
346524|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346525|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346526|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346527|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346528|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346529|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346530|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346531|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346532|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346533|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346534|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346535|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346592|NCT00339183|E1|Reported Event|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
346593|NCT00339833|B3|Baseline|Total|Total of all reporting groups
346594|NCT00339833|B2|Baseline|Placebo|Identical placebo for 7 days
346595|NCT00339833|B1|Baseline|Salsalate|Salsalate (3g/day) for 7 days
346536|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346537|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346538|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346539|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346540|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346541|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346542|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346543|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346544|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346545|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346546|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346547|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346596|NCT00339833|P2|Participant Flow|Placebo|Placebo for 7 days.
346597|NCT00339833|P1|Participant Flow|Salsalate|The intervention was salsalate (3g/day) for 7 days
346598|NCT00339833|O2|Outcome|Placebo|Identical placebo for 7 days
346599|NCT00339833|O1|Outcome|Salsalate|Salsalate (3g/day) for 7 days
346600|NCT00339833|O2|Outcome|Placebo|Identical placebo for 7 days
346601|NCT00339833|O1|Outcome|Salsalate|Salsalate (3g/day) for 7 days
346548|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346549|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346550|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346551|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346552|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346553|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346554|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346555|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346556|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346557|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346558|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346559|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346602|NCT00339833|E2|Reported Event|Placebo|Identical placebo for 7 days
346603|NCT00339833|E1|Reported Event|Salsalate|Salsalate (3g/day) for 7 days
346604|NCT00340379|B3|Baseline|Total|Total of all reporting groups
346605|NCT00340379|B2|Baseline|Sertraline/Haloperidol|
346606|NCT00340379|B1|Baseline|Ziprasidone|
346607|NCT00340379|P2|Participant Flow|Sertraline/Haloperidol|Target dosage of 150-200mg/day for sertraline and 6-8mg/day for haloperidol.
346560|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346561|NCT00339144|E3|Reported Event|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
346625|NCT00340678|P1|Participant Flow|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
346626|NCT00340678|O4|Outcome|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
346799|NCT00348283|O1|Outcome|Placebo|
346800|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
346562|NCT00339144|E2|Reported Event|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346563|NCT00339144|E1|Reported Event|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
346564|NCT00339183|B3|Baseline|Total|Total of all reporting groups
346565|NCT00339183|B2|Baseline|FOLFIRI Alone|Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
346566|NCT00339183|B1|Baseline|Panitumumab Plus FOLFIRI|Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
346567|NCT00339183|P2|Participant Flow|FOLFIRI Alone|Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
346568|NCT00339183|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
346569|NCT00339183|O2|Outcome|FOLFIRI Alone|Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346570|NCT00339183|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
346571|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346572|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346573|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346574|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346575|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346576|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346577|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346578|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346579|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346580|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346581|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346582|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346583|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346584|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346585|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346586|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346587|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
346619|NCT00340678|B3|Baseline|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
346620|NCT00340678|B2|Baseline|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
346621|NCT00340678|B1|Baseline|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
346622|NCT00340678|P4|Participant Flow|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
346623|NCT00340678|P3|Participant Flow|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
346627|NCT00340678|O3|Outcome|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
346628|NCT00340678|O2|Outcome|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
346629|NCT00340678|O1|Outcome|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
346630|NCT00340678|O4|Outcome|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
346631|NCT00340678|O3|Outcome|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
346632|NCT00340678|O2|Outcome|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
346633|NCT00340678|O1|Outcome|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
346634|NCT00340678|E2|Reported Event|Placebo|Subjects received placebo
346635|NCT00340678|E1|Reported Event|Losartan|Subjects received losartan
346636|NCT00340704|B10|Baseline|Total|Total of all reporting groups
346637|NCT00340704|B9|Baseline|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
346638|NCT00340704|B8|Baseline|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
346639|NCT00340704|B7|Baseline|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
346640|NCT00340704|B6|Baseline|Tamsulosin - High Dose Level (Group D-Denovo)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
347022|NCT00349713|O2|Outcome|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
346641|NCT00340704|B5|Baseline|Tamsulosin - Medium Dose Level (Group D-Denovo)|Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
346790|NCT00348283|B2|Baseline|Adalimumab 40 mg Every Other Week|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow.
346791|NCT00348283|B1|Baseline|Placebo|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow.
346792|NCT00348283|P2|Participant Flow|Adalimumab|40 mg SC eow
346793|NCT00348283|P1|Participant Flow|Placebo|SC dosing eow
346642|NCT00340704|B4|Baseline|Tamsulosin - Low Dose Level (Group D-Denovo)|Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
346643|NCT00340704|B3|Baseline|Tamsulosin - High Dose Level (PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
346644|NCT00340704|B2|Baseline|Tamsulosin - Medium Dose Level (PK Study)|Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
346645|NCT00340704|B1|Baseline|Tamsulosin - Low Dose Level (PK Study)|Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
346646|NCT00340704|P9|Participant Flow|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346647|NCT00340704|P8|Participant Flow|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346648|NCT00340704|P7|Participant Flow|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346777|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346649|NCT00340704|P6|Participant Flow|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346794|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
346650|NCT00340704|P5|Participant Flow|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346651|NCT00340704|P4|Participant Flow|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346652|NCT00340704|P3|Participant Flow|Tamsulosin - High Dose Level (PK Study)|"Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.
In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346653|NCT00340704|P2|Participant Flow|Tamsulosin - Medium Dose Level (PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346654|NCT00340704|P1|Participant Flow|Tamsulosin - Low Dose Level (PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346655|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346656|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
347023|NCT00349713|O1|Outcome|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
346657|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346795|NCT00348283|O1|Outcome|Placebo|
346658|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346659|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
346660|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346661|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346662|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
346663|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346664|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
347077|NCT00349921|B5|Baseline|Total|Total of all reporting groups
347125|NCT00350207|O3|Outcome|Placebo|Matching Placebo
346673|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346665|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
346666|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346667|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346668|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
346669|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346670|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346671|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
346672|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346801|NCT00348283|O1|Outcome|Placebo|
346674|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
346675|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346676|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346677|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
346678|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346679|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346680|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
346681|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346682|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346683|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
346684|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346685|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346686|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
346687|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346688|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
347078|NCT00349921|B4|Baseline|Adenosine First, Then Placebo|adenosine given in first injection placebo given in second injection
346697|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346689|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
346690|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346691|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.
Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346692|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
346693|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
346694|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
346695|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346696|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346778|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
346779|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
347122|NCT00350207|O3|Outcome|Placebo|Matching Placebo
346698|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346699|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346700|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346701|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346702|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346703|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346704|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
347123|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
346713|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346705|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346706|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346707|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346708|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346709|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346710|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346711|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346712|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346714|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346715|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346716|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346717|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346718|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346719|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346720|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346721|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346722|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346723|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346724|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346725|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346726|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346727|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346728|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
347393|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
346745|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346729|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346730|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346731|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346732|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346733|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346734|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346735|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346736|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346737|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346738|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346739|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346740|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346741|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.
Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
346742|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.
Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346743|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346744|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.
In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.
Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
346746|NCT00340704|E9|Reported Event|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
346747|NCT00340704|E8|Reported Event|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
346748|NCT00340704|E7|Reported Event|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
346749|NCT00340704|E6|Reported Event|Tamsulosin - High Dose Level (Group D-Denovo)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
346750|NCT00340704|E5|Reported Event|Tamsulosin - Medium Dose Level (Group D-Denovo)|Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
346751|NCT00340704|E4|Reported Event|Tamsulosin - Low Dose Level (Group D-Denovo)|Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
346752|NCT00340704|E3|Reported Event|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
346780|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
350636|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
346781|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
346782|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346783|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346753|NCT00340704|E2|Reported Event|Tamsulosin - Medium Dose Level (Steady State - PK Study)|Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
346754|NCT00340704|E1|Reported Event|Tamsulosin - Low Dose Level (Steady State - PK Study)|Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
346755|NCT00340834|B6|Baseline|Total|Total of all reporting groups
346756|NCT00340834|B5|Baseline|Interferon β-1a/Fingolimod 0.5 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
346757|NCT00340834|B4|Baseline|Interferon β-1a/Fingolimod 1.25 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
346758|NCT00340834|B3|Baseline|Interferon β-1a 30 µg|Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
346759|NCT00340834|B2|Baseline|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346760|NCT00340834|B1|Baseline|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346761|NCT00340834|P5|Participant Flow|Interferon β-1a/Fingolimod 0.5 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
346762|NCT00340834|P4|Participant Flow|Interferon β-1a/Fingolimod 1.25 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
346763|NCT00340834|P3|Participant Flow|Interferon β-1a 30 µg|Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
346764|NCT00340834|P2|Participant Flow|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346765|NCT00340834|P1|Participant Flow|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346766|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
346767|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346768|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346769|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
346770|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346771|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346772|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
346773|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346774|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
346775|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
346776|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
347024|NCT00349713|E3|Reported Event|Cohort 3: Rabies Vaccine (RabAvert)|Rabies vaccine, All events reports instead of AE's per vaccination group 20 subjects (10 from Cohort 1 and 10 from Cohort 2)
346802|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
346803|NCT00348283|O1|Outcome|Placebo|
346804|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
346805|NCT00348283|O1|Outcome|Placebo|
346806|NCT00348283|E2|Reported Event|Adalimumab|All subjects (135 subjects) enrolled in the study received adalimumab 160 mg at Baseline followed by adalimumab 80 mg at Week 2 (Induction dose).
346807|NCT00348283|E1|Reported Event|Placebo|
346808|NCT00348348|B3|Baseline|Total|Total of all reporting groups
346809|NCT00348348|B2|Baseline|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
346810|NCT00348348|B1|Baseline|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
346811|NCT00348348|P2|Participant Flow|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
346812|NCT00348348|P1|Participant Flow|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
346813|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
346814|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
346815|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
346816|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
346817|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
346818|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
346819|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
346820|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
346821|NCT00348348|E2|Reported Event|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
346822|NCT00348348|E1|Reported Event|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
346823|NCT00348374|B3|Baseline|Total|Total of all reporting groups
346824|NCT00348374|B2|Baseline|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346825|NCT00348374|B1|Baseline|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346826|NCT00348374|P2|Participant Flow|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346827|NCT00348374|P1|Participant Flow|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346879|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
347025|NCT00349713|E2|Reported Event|Cohort 2: 50 ug FMP2.1 / AS02A|50 ug FMP2.1 / AS02A
347026|NCT00349713|E1|Reported Event|Cohort 1: 25 ug FMP2.1 / AS02|25 ug FMPs.1 / AS02
346828|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346829|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346830|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346831|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346832|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346833|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346834|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346835|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346836|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346837|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346838|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346839|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346840|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346841|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346842|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346843|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346844|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
346845|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346846|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346847|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346848|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346849|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346850|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346851|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346852|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346853|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346854|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346855|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346856|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346857|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346858|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346859|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346860|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
347019|NCT00349713|O2|Outcome|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
346861|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346862|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346863|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346864|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346865|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346866|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346867|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346868|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346869|NCT00348374|E2|Reported Event|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
346870|NCT00348374|E1|Reported Event|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
346871|NCT00349336|B3|Baseline|Total|Total of all reporting groups
346872|NCT00349336|B2|Baseline|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
346873|NCT00349336|B1|Baseline|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
346874|NCT00349336|P2|Participant Flow|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
346875|NCT00349336|P1|Participant Flow|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
346876|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
346877|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
346878|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
347027|NCT00349752|B3|Baseline|Total|Total of all reporting groups
346880|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
346881|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
346882|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
346883|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
346884|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
346885|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
346886|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
346887|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
346888|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
346889|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
346890|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
346891|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
346892|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
346893|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
346894|NCT00349336|E2|Reported Event|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
346895|NCT00349336|E1|Reported Event|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
346896|NCT00349349|B4|Baseline|Total|Total of all reporting groups
346897|NCT00349349|B3|Baseline|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346898|NCT00349349|B2|Baseline|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346899|NCT00349349|B1|Baseline|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
347020|NCT00349713|O1|Outcome|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
346900|NCT00349349|P3|Participant Flow|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346901|NCT00349349|P2|Participant Flow|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346902|NCT00349349|P1|Participant Flow|2000 mg Ofatumumab + DR|Ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The independent endpoint review committee (IRC) classified these participants as double refractory (DR), defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346903|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
346904|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
346905|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
346906|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined
346967|NCT00349388|B1|Baseline|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day
Asacol: Asacol is given once a day versus twice or three times a day"
346907|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
346908|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346909|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346910|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346911|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346912|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346913|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346914|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346915|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346916|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346917|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346918|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346919|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
347021|NCT00349713|O3|Outcome|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
346920|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346921|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346922|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346923|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346924|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346925|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346968|NCT00349388|P2|Participant Flow|Asacol BID/TID Dosing|"Asacol total dose split BID or TID
Asacol: Asacol is given once a day versus twice or three times a day"
347697|NCT00351533|B3|Baseline|Total|Total of all reporting groups
346926|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346927|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346928|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346929|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346930|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346931|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346932|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346933|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346934|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346935|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346936|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346937|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346938|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346939|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346940|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346941|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346942|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346943|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346944|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346945|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346946|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346947|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346948|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346949|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346950|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346951|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346952|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346953|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346954|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346955|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346956|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346957|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346958|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346959|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346960|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346961|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346962|NCT00349349|E3|Reported Event|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
346963|NCT00349349|E2|Reported Event|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
346964|NCT00349349|E1|Reported Event|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
346965|NCT00349388|B3|Baseline|Total|Total of all reporting groups
346966|NCT00349388|B2|Baseline|Asacol BID/TID Dosing|"Asacol total dose split BID or TID
Asacol: Asacol is given once a day versus twice or three times a day"
347150|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
346969|NCT00349388|P1|Participant Flow|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day
Asacol: Asacol is given once a day versus twice or three times a day"
346970|NCT00349388|O2|Outcome|Asacol BID/TID Dosing|"Asacol total dose split BID or TID
Asacol: Asacol is given once a day versus twice or three times a day"
346971|NCT00349388|O1|Outcome|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day
Asacol: Asacol is given once a day versus twice or three times a day"
346972|NCT00349388|E2|Reported Event|Asacol BID/TID Dosing|"Asacol total dose split BID or TID
Asacol: Asacol is given once a day versus twice or three times a day"
346973|NCT00349388|E1|Reported Event|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day
Asacol: Asacol is given once a day versus twice or three times a day"
346974|NCT00349466|B3|Baseline|Total|Total of all reporting groups
346975|NCT00349466|B2|Baseline|Placebo|Placebo tablets q12 hours for 12 weeks
346976|NCT00349466|B1|Baseline|CF101 1 mg|CF101 1 mg q12 hours
346977|NCT00349466|P2|Participant Flow|Placebo|Placebo tablets q12 hours for 12 weeks
346978|NCT00349466|P1|Participant Flow|CF101 1 mg|CF101 1 mg q12 hours
346979|NCT00349466|O2|Outcome|Placebo BID|Oral tablets given every 12 hours for 12 weeks
346980|NCT00349466|O1|Outcome|CF101 1 mg BID|Oral tablets given every 12 hours for 12 weeks
346981|NCT00349466|E2|Reported Event|Placebo|Placebo tablets q12 hours for 12 weeks
346982|NCT00349466|E1|Reported Event|CF101 1 mg|CF101 1 mg q12 hours
346983|NCT00349622|B3|Baseline|Total|Total of all reporting groups
346984|NCT00349622|B2|Baseline|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
346985|NCT00349622|B1|Baseline|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
346986|NCT00349622|P2|Participant Flow|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
346987|NCT00349622|P1|Participant Flow|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
346988|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
346989|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
346990|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
346991|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
347070|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
347071|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
346992|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
346993|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
346994|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
346995|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
346996|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
346997|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
347037|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
346998|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
346999|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
347000|NCT00349622|E2|Reported Event|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
347001|NCT00349622|E1|Reported Event|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
347002|NCT00349713|B4|Baseline|Total|Total of all reporting groups
347003|NCT00349713|B3|Baseline|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
347004|NCT00349713|B2|Baseline|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
347005|NCT00349713|B1|Baseline|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
347006|NCT00349713|P3|Participant Flow|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
347007|NCT00349713|P2|Participant Flow|Cohort 2: FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
347008|NCT00349713|P1|Participant Flow|Cohort 1: FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
347009|NCT00349713|O3|Outcome|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
347010|NCT00349713|O2|Outcome|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
347011|NCT00349713|O1|Outcome|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
347012|NCT00349713|O3|Outcome|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
347013|NCT00349713|O2|Outcome|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
347014|NCT00349713|O1|Outcome|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
347015|NCT00349713|O3|Outcome|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
347016|NCT00349713|O2|Outcome|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
347017|NCT00349713|O1|Outcome|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
347018|NCT00349713|O3|Outcome|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
347072|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
347073|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
347028|NCT00349752|B2|Baseline|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347029|NCT00349752|B1|Baseline|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347030|NCT00349752|P2|Participant Flow|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347031|NCT00349752|P1|Participant Flow|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347032|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347033|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347034|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347035|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347036|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347038|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347039|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347040|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347041|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347042|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347043|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347044|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347045|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347046|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347047|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347048|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347049|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347050|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347051|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347052|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347053|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347054|NCT00349752|E2|Reported Event|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347055|NCT00349752|E1|Reported Event|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
347056|NCT00349908|B3|Baseline|Total|Total of all reporting groups
347057|NCT00349908|B2|Baseline|Atherosclerosis Arm|Symptomatic stenosis in intracranial arteries
347058|NCT00349908|B1|Baseline|Aneurysm Arm|Intracranial wide-necked aneurysms
347059|NCT00349908|P2|Participant Flow|Atherosclerosis Arm|Symptomatic stenosis in intracranial arteries
347060|NCT00349908|P1|Participant Flow|Aneurysm Arm|Intracranial wide-necked aneurysms
347061|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
347062|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
347063|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
347064|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
347065|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
347066|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
347067|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
347068|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
347069|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
347079|NCT00349921|B3|Baseline|Clonidine Given First, Then Placebo|clonidine given first placebo given in second injection
347080|NCT00349921|B2|Baseline|Adenosine Given First, Then Clonidine|adenosine given in first injection clonidine given in second injection
347081|NCT00349921|B1|Baseline|Clonidine First, Then Adenosine|clonidine given in first injection adenosine given in second injection
347082|NCT00349921|P4|Participant Flow|Adenosine First, Then Placebo|Adenosine given during the first period and placebo given during the second
347083|NCT00349921|P3|Participant Flow|Clonidine First, Then Placebo|Clonidine given as during the first period, then placebo during the second
347084|NCT00349921|P2|Participant Flow|Adenosine First, Then Clonidine|Adenosine given during the first period and adenosine given during the second
347085|NCT00349921|P1|Participant Flow|Clonidine First, Then Adenosine|Clonidine given during the first period and adenosine given during the second period
347086|NCT00349921|O3|Outcome|Placebo|Placebo received as either first or second injection
347087|NCT00349921|O2|Outcome|Adenosine|Adenosine received as either first or second injection
347088|NCT00349921|O1|Outcome|Clonidine|clonidine received as either first or second injection
347089|NCT00349921|E4|Reported Event|Adenosine First, Then Placebo|adenosine given in first injection placebo given in second injection
347090|NCT00349921|E3|Reported Event|Clonidine First, Then Placebo|clonidine given first placebo given in second injection
347091|NCT00349921|E2|Reported Event|Adenosine First, Then Clonidine|adenosine given in first injection clonidine given in second injection
347092|NCT00349921|E1|Reported Event|Clonidine First, Then Adenosine|clonidine given in first injection adenosine given in second injection
347093|NCT00350025|B3|Baseline|Total|Total of all reporting groups
347094|NCT00350025|B2|Baseline|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
347095|NCT00350025|B1|Baseline|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
347096|NCT00350025|P2|Participant Flow|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
347097|NCT00350025|P1|Participant Flow|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
347098|NCT00350025|O2|Outcome|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
347099|NCT00350025|O1|Outcome|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
347100|NCT00350025|O2|Outcome|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
347101|NCT00350025|O1|Outcome|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
347102|NCT00350025|E2|Reported Event|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
347103|NCT00350025|E1|Reported Event|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
347104|NCT00350142|B1|Baseline|SBRT|25 Gy single fraction dose using Trilogy linear accelerator
347105|NCT00350142|P1|Participant Flow|Stereotactic Body Radiotherapy|"patients that received a single fraction of 25 Gy Stereotactic Body Radiotherapy followed by weekly Gemcitabine administered at 1000mg/m2 over 100 minutes.
Patients will be followed at 4-6 weeks, 3 months, 6 months, 9 months and 1 year, in year 2 follow up will be every 4 months and in year 3 follow up will be every 6 months."
347106|NCT00350142|O1|Outcome|Stereotactic Body Radiotherapy|"single fraction 25 Gy dose Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine
Stereotactic Body Radiotherapy: Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator
Gemcitabine: Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes"
347107|NCT00350142|O1|Outcome|Stereotactic Radiosurgery|patients w/ pancreas Cancer receiving Stereotactic Radiosurgery and Gemcitabine
347108|NCT00350142|E1|Reported Event|SBRT With Gem|patient with locally advanced pancreas cancer receiving Gem + SBRT
347109|NCT00350207|B4|Baseline|Total|Total of all reporting groups
347110|NCT00350207|B3|Baseline|Placebo|Matching Placebo
347111|NCT00350207|B2|Baseline|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347112|NCT00350207|B1|Baseline|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347113|NCT00350207|P3|Participant Flow|Placebo|Matching Placebo
347114|NCT00350207|P2|Participant Flow|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347115|NCT00350207|P1|Participant Flow|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347116|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347117|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347118|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347119|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347120|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347121|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347126|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347127|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347128|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347129|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347130|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347131|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347132|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347133|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347134|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347135|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347136|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347137|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347138|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347139|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347140|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347141|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347142|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347143|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347144|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347145|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347146|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347147|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347148|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347149|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347151|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347152|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347153|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347154|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347155|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347156|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347157|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347158|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347159|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347160|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347161|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347162|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347163|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347164|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347165|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347166|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347167|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347168|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347169|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347170|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347171|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347172|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347173|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347174|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347175|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347176|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347177|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347178|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347179|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347180|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347181|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347182|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347183|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347184|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347185|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347186|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347187|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347188|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347189|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347190|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347191|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347192|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347193|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347194|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347195|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347196|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347197|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347198|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347199|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347200|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347201|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347202|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347203|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347204|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347205|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347206|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347207|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347208|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347209|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347210|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347211|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347212|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347213|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347214|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347215|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347216|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347217|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347218|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347219|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347220|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347221|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347222|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347223|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347224|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347225|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347226|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347227|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347228|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347229|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347230|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347231|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347232|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347233|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347234|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347235|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347236|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347237|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347238|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347239|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347240|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347241|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347242|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347243|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347244|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347245|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347246|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347247|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347248|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347249|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347250|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347251|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347252|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347253|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347254|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347255|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347256|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347257|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347258|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347259|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347260|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347261|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347262|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347263|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347264|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347265|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347266|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347267|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347268|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347269|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347270|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347271|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347272|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347273|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347274|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347275|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347276|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347277|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347278|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347279|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347280|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347281|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347282|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347283|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347284|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347285|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347286|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347287|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347288|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347289|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347290|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347291|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347292|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347293|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347294|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347295|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347296|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347297|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347298|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347299|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347300|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347301|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347302|NCT00350207|O3|Outcome|Placebo|Matching Placebo
347303|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347304|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347305|NCT00350207|E3|Reported Event|Placebo|Matching Placebo
347306|NCT00350207|E2|Reported Event|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
347307|NCT00350207|E1|Reported Event|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
347308|NCT00350220|B3|Baseline|Total|Total of all reporting groups
347309|NCT00350220|B2|Baseline|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
347310|NCT00350220|B1|Baseline|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
347311|NCT00350220|P2|Participant Flow|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
347312|NCT00350220|P1|Participant Flow|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
347313|NCT00350220|O2|Outcome|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
347314|NCT00350220|O1|Outcome|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
347315|NCT00350220|O2|Outcome|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
347316|NCT00350220|O1|Outcome|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
347317|NCT00350220|E2|Reported Event|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
347318|NCT00350220|E1|Reported Event|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
347319|NCT00350272|B3|Baseline|Total|Total of all reporting groups
347320|NCT00350272|B2|Baseline|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
347321|NCT00350272|B1|Baseline|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
347322|NCT00350272|P2|Participant Flow|Lamivudine,Efavirenz,Tenofovir|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
347323|NCT00350272|P1|Participant Flow|Elvucitabine, Efavirenz,Tenofovir|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
347324|NCT00350272|O2|Outcome|Lamivudine,Efavirenz,Tenofovir|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
347325|NCT00350272|O1|Outcome|Elvucitabine, Efavirenz,Tenofovir|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
350637|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
347326|NCT00350272|O2|Outcome|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
347327|NCT00350272|O1|Outcome|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
347328|NCT00350272|E2|Reported Event|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
347329|NCT00350272|E1|Reported Event|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
347330|NCT00350363|B1|Baseline|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
347331|NCT00350363|P1|Participant Flow|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
347332|NCT00350363|O1|Outcome|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
347333|NCT00350363|E1|Reported Event|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
347334|NCT00350402|B3|Baseline|Total|Total of all reporting groups
347335|NCT00350402|B2|Baseline|Sham MST|Low intensity muscle strength training (5% MIP)
347336|NCT00350402|B1|Baseline|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
347337|NCT00350402|P2|Participant Flow|Sham MST|Low intensity muscle strength training (5% MIP)
347338|NCT00350402|P1|Participant Flow|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
347339|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"This intervention is identical in all ways to real treatment, except that training device requires less inspiratory effort. The training device is set at 5% MIP. )"
347340|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|Same as previously described. This intervention involves high intensity respiratory muscle strength training over 4 week period, 5 days a week, with training device set at 75% maximal inspiratory pressure (MIP). The MIP is determined weekly and the training device recalibrated to take into account changes.
347341|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|Low intensity muscle strength training (5% MIP)
347342|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|high intensity respiratory muscle strength training, 75% MIP
347343|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"Same as previously described. The Sham IMST intervention was identical to the real intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training."
347344|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|"Same as previously described. High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take deep breaths and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff."
347345|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"The Sham IMST intervention was identical to the real intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training."
347346|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|"High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take deep breaths and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff."
347347|NCT00350402|E2|Reported Event|Sham MST|Low intensity muscle strength training (5% MIP)
347348|NCT00350402|E1|Reported Event|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
347349|NCT00350519|B3|Baseline|Total|Total of all reporting groups
347350|NCT00350519|B2|Baseline|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
347351|NCT00350519|B1|Baseline|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
347352|NCT00350519|P2|Participant Flow|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
347353|NCT00350519|P1|Participant Flow|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
347354|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
347355|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
347356|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
347357|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
347358|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
347394|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
347359|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
347360|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
347361|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
347362|NCT00350519|E2|Reported Event|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
347363|NCT00350519|E1|Reported Event|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
347364|NCT00350532|B3|Baseline|Total|Total of all reporting groups
347365|NCT00350532|B2|Baseline|Healthy Subjects|Healthy subjects with no existing pain conditions. Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.
347366|NCT00350532|B1|Baseline|Neuropathic Pain Subjects|Subjects with existing neuropathic pain Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.
347367|NCT00350532|P2|Participant Flow|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
347368|NCT00350532|P1|Participant Flow|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
347369|NCT00350532|O2|Outcome|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
347370|NCT00350532|O1|Outcome|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
347371|NCT00350532|E2|Reported Event|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
347372|NCT00350532|E1|Reported Event|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
347373|NCT00350623|B4|Baseline|Total|Total of all reporting groups
347374|NCT00350623|B3|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347375|NCT00350623|B2|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347376|NCT00350623|B1|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347377|NCT00350623|P3|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347378|NCT00350623|P2|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347379|NCT00350623|P1|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347380|NCT00350623|O3|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347381|NCT00350623|O2|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347382|NCT00350623|O1|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347383|NCT00350623|E3|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347384|NCT00350623|E2|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347385|NCT00350623|E1|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
347386|NCT00350636|B3|Baseline|Total|Total of all reporting groups
347387|NCT00350636|B2|Baseline|Placebo Topical Gel|1 g placebo topical gel
347388|NCT00350636|B1|Baseline|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
347389|NCT00350636|P2|Participant Flow|Placebo Topical Gel|1 g placebo topical gel
347390|NCT00350636|P1|Participant Flow|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
347391|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
347392|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
347396|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
347397|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
347398|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
347399|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
347400|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
347401|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
347402|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
347403|NCT00350636|E2|Reported Event|Placebo Topical Gel|1 g placebo topical gel
347404|NCT00350636|E1|Reported Event|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
347405|NCT00350727|B4|Baseline|Total|Total of all reporting groups
347406|NCT00350727|B3|Baseline|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347407|NCT00350727|B2|Baseline|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347408|NCT00350727|B1|Baseline|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
347409|NCT00350727|P3|Participant Flow|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347410|NCT00350727|P2|Participant Flow|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347411|NCT00350727|P1|Participant Flow|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
347412|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347413|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347414|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347415|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed EGFRvIII and/or PTEN.
347416|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347417|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347418|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347419|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347420|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347421|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347422|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347423|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed EGFRvIII and/or PTEN.
347424|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347425|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347426|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347427|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347428|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347429|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347430|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347431|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347432|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347433|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347434|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347435|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347436|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347437|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347438|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347439|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347440|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347441|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347442|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347443|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347444|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347445|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347446|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347447|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347448|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347449|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347450|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347451|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347452|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347453|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347454|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347455|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347456|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347457|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347458|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347459|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347460|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347461|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347462|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347463|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347464|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347465|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347466|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347467|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347468|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347469|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347470|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347471|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347472|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347473|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347474|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347475|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347476|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg /Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347477|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg /Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347478|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347479|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347480|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347481|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347482|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347483|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347484|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347485|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347486|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347487|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347488|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347489|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347490|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347491|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347492|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347493|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347494|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347495|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347496|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347497|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347498|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347499|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347500|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347501|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347502|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347503|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347504|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347505|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347506|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347507|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347508|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
347509|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
347510|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
347511|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
347512|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg /Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
347513|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg /Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
347514|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347515|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347516|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347517|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347518|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347519|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347520|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347521|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347522|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347523|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347524|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347525|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347526|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347527|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347528|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347628|NCT00351273|P1|Participant Flow|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
347629|NCT00351273|O3|Outcome|Placebo|Participants will receive placebo
347529|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347530|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347531|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347532|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347533|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347534|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347535|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347536|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347537|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347538|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347539|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347540|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347541|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347542|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
347543|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347544|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347545|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
347546|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347547|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347548|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
347549|NCT00350727|E3|Reported Event|Phase II: Biomarker Negative|All participants received pazopanib 400 mg QD and lapatinib 1000 mg QD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
347550|NCT00350727|E2|Reported Event|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (QD) and lapatinib 1000 mg QD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
347551|NCT00350727|E1|Reported Event|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
347552|NCT00350779|B3|Baseline|Total|Total of all reporting groups
347553|NCT00350779|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347630|NCT00351273|O2|Outcome|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
350638|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
347554|NCT00350779|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347555|NCT00350779|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347556|NCT00350779|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347557|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347558|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347559|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347588|NCT00350870|B2|Baseline|Disulfiram|"Disulfiram (plus CBT)
disulfiram: 250mg per day of Disulfiram plus CBT"
347589|NCT00350870|B1|Baseline|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo: Placebo plus CBT"
349557|NCT00359021|O3|Outcome|All Participants|DUET Placebo + DUET TMC125
347560|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347561|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347562|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347563|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347564|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347565|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347566|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347567|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347568|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347569|NCT00350779|E4|Reported Event|Placebo Data Through Week 54|
347570|NCT00350779|E3|Reported Event|Sitagliptin 100 mg Data Through Week 54|
347571|NCT00350779|E2|Reported Event|Placebo Data Through Week 18|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347572|NCT00350779|E1|Reported Event|Sitagliptin 100 mg Data Through Week 18|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
347573|NCT00350792|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
347574|NCT00350792|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
347575|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
347576|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
347577|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
347578|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
347579|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
347580|NCT00350792|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
347581|NCT00350844|B1|Baseline|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
347582|NCT00350844|P1|Participant Flow|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
347583|NCT00350844|O1|Outcome|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
347584|NCT00350844|E1|Reported Event|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
347585|NCT00350870|B5|Baseline|Total|Total of all reporting groups
347586|NCT00350870|B4|Baseline|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
347587|NCT00350870|B3|Baseline|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
347590|NCT00350870|P4|Participant Flow|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
347591|NCT00350870|P3|Participant Flow|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
347592|NCT00350870|P2|Participant Flow|Disulfiram|"Disulfiram (plus CBT)
disulfiram: 250mg per day of Disulfiram plus CBT"
347593|NCT00350870|P1|Participant Flow|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo: Placebo plus CBT"
347594|NCT00350870|O4|Outcome|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
347595|NCT00350870|O3|Outcome|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
347596|NCT00350870|O2|Outcome|Disulfiram|"Disulfiram (plus CBT)
disulfiram: 250mg per day of Disulfiram plus CBT"
347597|NCT00350870|O1|Outcome|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo: Placebo plus CBT"
347598|NCT00350870|O4|Outcome|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
347599|NCT00350870|O3|Outcome|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
347600|NCT00350870|O2|Outcome|Disulfiram|"Disulfiram (plus CBT)
disulfiram: 250mg per day of Disulfiram plus CBT"
347601|NCT00350870|O1|Outcome|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo: Placebo plus CBT"
347602|NCT00350870|E4|Reported Event|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
347603|NCT00350870|E3|Reported Event|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
347604|NCT00350870|E2|Reported Event|Disulfiram|"Disulfiram (plus CBT)
disulfiram: 250mg per day of Disulfiram plus CBT"
347605|NCT00350870|E1|Reported Event|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)
Placebo: Placebo plus CBT"
347606|NCT00351000|B1|Baseline|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
347607|NCT00351000|P1|Participant Flow|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
347608|NCT00351000|O2|Outcome|Olanzapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dose will be unchanged during the trial.
347609|NCT00351000|O1|Outcome|Clozapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dose will be unchanged during the trial.
347631|NCT00351273|O1|Outcome|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
347610|NCT00351000|O2|Outcome|Olanzapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's olanzapine dosage will be unchanged during the trial.
347611|NCT00351000|O1|Outcome|Clozapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dosage will be unchanged during the trial.
347612|NCT00351000|E1|Reported Event|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
347613|NCT00351039|B1|Baseline|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:
Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
347614|NCT00351039|P1|Participant Flow|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:
Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
347696|NCT00351468|E1|Reported Event|Eltrombopag, Treatment + 1 Day|Eltrombopag, Treatment + 1 day
347615|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:
Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
347616|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:
Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
347617|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:
Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
347618|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:
Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
347619|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:
Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
347620|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:
Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
347621|NCT00351039|E1|Reported Event|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:
Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
347622|NCT00351273|B4|Baseline|Total|Total of all reporting groups
347623|NCT00351273|B3|Baseline|Placebo|Participants will receive placebo
347624|NCT00351273|B2|Baseline|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
347625|NCT00351273|B1|Baseline|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
347626|NCT00351273|P3|Participant Flow|Placebo|Participants will receive placebo
347627|NCT00351273|P2|Participant Flow|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
347632|NCT00351273|E3|Reported Event|Placebo|Participants will receive placebo
347633|NCT00351273|E2|Reported Event|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
347634|NCT00351273|E1|Reported Event|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
347635|NCT00351299|B3|Baseline|Total|Total of all reporting groups
347636|NCT00351299|B2|Baseline|Standard of Care|Standard of care per treating physician preference
347637|NCT00351299|B1|Baseline|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine
Dexmedetomidine: dexmedetomidine infusion titrated to effect"
347638|NCT00351299|P2|Participant Flow|Standard of Care|Standard of care per treating physician preference
347639|NCT00351299|P1|Participant Flow|Infusion of Dexmedetomidine|"infusion 0.2-0.7 dexmedetomidine
Dexmedetomidine: dexmedetomidine infusion titrated to effect"
347640|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per treating physician's preference
347641|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine
Dexmedetomidine: dexmedetomidine infusion titrated to effect"
347642|NCT00351299|O2|Outcome|Standard of Care|Standard of care per attending physician's preference
347643|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine
Dexmedetomidine: dexmedetomidine infusion titrated to effect"
347644|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per attending physician preference
347645|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine
Dexmedetomidine: dexmedetomidine infusion titrated to effect"
347646|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per treating physician preference
347647|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine
Dexmedetomidine: dexmedetomidine infusion titrated to effect"
347648|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per treating attending physician preference
347649|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine
Dexmedetomidine: dexmedetomidine infusion titrated to effect"
347650|NCT00351299|E2|Reported Event|Standard of Care|Standard of care per treating physician preference
347651|NCT00351299|E1|Reported Event|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine
Dexmedetomidine: dexmedetomidine infusion titrated to effect"
347652|NCT00351351|B3|Baseline|Total|Total of all reporting groups
347653|NCT00351351|B2|Baseline|Currently Available Lithotripsy Techology|"Currently available lithotripsy technology
single probe ultrasonic : FDA-approved - single probe ultrasonic"
347654|NCT00351351|B1|Baseline|Cyberwand|"Cyberwand
Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
347655|NCT00351351|P2|Participant Flow|Currently Available Lithotripsy Technology|"Currently available lithotripsy technology
single probe ultrasonic : FDA-approved - single probe ultrasonic"
347656|NCT00351351|P1|Participant Flow|Cyberwand|"Cyberwand
Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
347657|NCT00351351|O2|Outcome|Currently Available Lithotripsy Techology|"Currently available lithotripsy technology
single probe ultrasonic : FDA-approved - single probe ultrasonic"
347658|NCT00351351|O1|Outcome|Cyberwand|"Cyberwand
Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
347659|NCT00351351|E2|Reported Event|Currently Available Lithotripsy Technology|"Currently available lithotripsy technology
single probe ultrasonic : FDA-approved - single probe ultrasonic"
347660|NCT00351351|E1|Reported Event|Cyberwand|"Cyberwand
Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
347661|NCT00351377|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347662|NCT00351377|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347663|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347664|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347665|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347666|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347667|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347668|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347669|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347670|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347671|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347672|NCT00351377|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
347673|NCT00351416|B3|Baseline|Total|Total of all reporting groups
347674|NCT00351416|B2|Baseline|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
347675|NCT00351416|B1|Baseline|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
347676|NCT00351416|P2|Participant Flow|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
347677|NCT00351416|P1|Participant Flow|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
347678|NCT00351416|O2|Outcome|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
347679|NCT00351416|O1|Outcome|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
347680|NCT00351416|E2|Reported Event|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
347681|NCT00351416|E1|Reported Event|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
347682|NCT00351468|B1|Baseline|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347683|NCT00351468|P1|Participant Flow|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347684|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347685|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347686|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347687|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347688|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347689|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
350639|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
347690|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347691|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347692|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347693|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347694|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
347695|NCT00351468|E2|Reported Event|Eltrombopag, >1 to 30 Days Post-Therapy|Eltrombopag, >1 to 30 Days Post-Therapy
347698|NCT00351533|B2|Baseline|Enteral Saline|7.5cc 0.9% saline every 6 hours
347699|NCT00351533|B1|Baseline|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347700|NCT00351533|P2|Participant Flow|Enteral Saline|7.5cc 0.9% saline every 6 hours
347701|NCT00351533|P1|Participant Flow|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347702|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347703|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347704|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347705|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347706|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347707|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347708|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347709|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347710|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347711|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347712|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347713|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347714|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347715|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347716|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347717|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347718|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347719|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347720|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347721|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347722|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347723|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347724|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347725|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347726|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347727|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347728|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347729|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347730|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347731|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347732|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347733|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347734|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347735|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347736|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347737|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347738|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347790|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.
placebo"
347739|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347740|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347741|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347742|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347743|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347744|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347745|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347746|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347747|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347748|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347749|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347750|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347751|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347752|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347753|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347754|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347755|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347756|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
347757|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347758|NCT00351533|E2|Reported Event|Enteral Saline|7.5cc 0.9% saline every 6 hours
347759|NCT00351533|E1|Reported Event|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
347760|NCT00338455|B3|Baseline|Total|Total of all reporting groups
347761|NCT00338455|B2|Baseline|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347762|NCT00338455|B1|Baseline|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347763|NCT00338455|P2|Participant Flow|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347764|NCT00338455|P1|Participant Flow|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347765|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347766|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347767|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347768|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347769|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347770|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347771|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347772|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347773|NCT00338455|E2|Reported Event|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347774|NCT00338455|E1|Reported Event|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
347775|NCT00338598|B3|Baseline|Total|Total of all reporting groups
347776|NCT00338598|B2|Baseline|Placebo|"placebo will be administered.
placebo"
347777|NCT00338598|B1|Baseline|Glycine|"Glycine, 0.8 gr per kg given in two daily doses
Glycine: Glycine, 0.8 gr per kg given in two daily doses"
347778|NCT00338598|P2|Participant Flow|Placebo|"placebo will be administered.
placebo"
347779|NCT00338598|P1|Participant Flow|Glycine|"Glycine, 0.8 gr per kg given in two daily doses
Glycine: Glycine, 0.8 gr per kg given in two daily doses"
347780|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.
placebo"
347781|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses
Glycine: Glycine, 0.8 gr per kg given in two daily doses"
347782|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.
placebo"
347783|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses
Glycine: Glycine, 0.8 gr per kg given in two daily doses"
347784|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.
placebo"
347785|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses
Glycine: Glycine, 0.8 gr per kg given in two daily doses"
347786|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.
placebo"
347787|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses
Glycine: Glycine, 0.8 gr per kg given in two daily doses"
347788|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.
placebo"
347789|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses
Glycine: Glycine, 0.8 gr per kg given in two daily doses"
347791|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses
Glycine: Glycine, 0.8 gr per kg given in two daily doses"
347792|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.
placebo"
347793|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses
Glycine: Glycine, 0.8 gr per kg given in two daily doses"
347794|NCT00338598|E2|Reported Event|Placebo|"placebo will be administered.
placebo"
347795|NCT00338598|E1|Reported Event|Glycine|"Glycine, 0.8 gr per kg given in two daily doses
Glycine: Glycine, 0.8 gr per kg given in two daily doses"
347796|NCT00338741|B3|Baseline|Total|Total of all reporting groups
347797|NCT00338741|B2|Baseline|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
347798|NCT00338741|B1|Baseline|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
347799|NCT00338741|P2|Participant Flow|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
347800|NCT00338741|P1|Participant Flow|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
347801|NCT00338741|O2|Outcome|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
347802|NCT00338741|O1|Outcome|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
347803|NCT00338741|O2|Outcome|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
347804|NCT00338741|O1|Outcome|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
347805|NCT00338741|E2|Reported Event|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
347806|NCT00338741|E1|Reported Event|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
347807|NCT00338806|B3|Baseline|Total|Total of all reporting groups
347808|NCT00338806|B2|Baseline|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347809|NCT00338806|B1|Baseline|IPT- Prevention for Adolescents|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347810|NCT00338806|P2|Participant Flow|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347811|NCT00338806|P1|Participant Flow|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347812|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347813|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347814|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347815|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347816|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347817|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347818|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347819|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347820|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347845|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
348243|NCT00352664|B1|Baseline|Donepezil|Oral Donepezil 5 mg daily x 7 days
347821|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347822|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347823|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347824|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347825|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347826|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347827|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347828|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347829|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347830|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347831|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347832|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347833|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347834|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347835|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347836|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347837|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347838|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347839|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347840|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347841|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347842|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347843|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347844|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347984|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
347846|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347847|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347848|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347849|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347850|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347851|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347852|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347853|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347854|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347855|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347856|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347857|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347858|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347859|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347860|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347861|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347862|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347863|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347864|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347865|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347866|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
347867|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
347868|NCT00338806|E2|Reported Event|Educational Clinical Monitoring|"Participants will receive educational clinical monitoring
Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
347869|NCT00338806|E1|Reported Event|Interpersonal Psychotherapy for Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents
Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
347870|NCT00338884|B1|Baseline|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347871|NCT00338884|P1|Participant Flow|Sunitinib|37.5 milligrams (mg) oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347872|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
348244|NCT00352664|P2|Participant Flow|Placebo|Oral Placebo tablet daily x 7 days
347873|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347874|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347875|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347876|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347877|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347878|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347879|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347880|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347881|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347882|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347883|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347884|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347885|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347886|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347887|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347888|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347889|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347890|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347891|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347892|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347893|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347894|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347895|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347896|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347897|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347898|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347899|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347900|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347901|NCT00338884|E1|Reported Event|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
347902|NCT00344682|B3|Baseline|Total|Total of all reporting groups
347903|NCT00344682|B2|Baseline|Memantine|memantine : memantine 5mg - 20mg PO daily
347904|NCT00344682|B1|Baseline|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
347905|NCT00344682|P2|Participant Flow|Memantine|memantine : memantine 5mg - 20mg PO daily
347906|NCT00344682|P1|Participant Flow|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
347907|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
347908|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
347909|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
347910|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
347911|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
347912|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
347913|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
347914|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
347915|NCT00344682|E2|Reported Event|Memantine|memantine : memantine 5mg - 20mg PO daily
347916|NCT00344682|E1|Reported Event|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
347917|NCT00344773|B1|Baseline|Gefitinib|Gefitinib 250mg tablet
347918|NCT00344773|P1|Participant Flow|Gefitinib|Gefitinib 250mg tablet
347919|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
347920|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
347921|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
347922|NCT00344773|E1|Reported Event|Gefitinib|Gefitinib 250mg tablet
347923|NCT00344968|B4|Baseline|Total|Total of all reporting groups
347924|NCT00344968|B3|Baseline|0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
347925|NCT00344968|B2|Baseline|0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
347926|NCT00344968|B1|Baseline|Sham Comparator|Procedure: Standard of care laser photocoagulation
347927|NCT00344968|P3|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
347928|NCT00344968|P2|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
347929|NCT00344968|P1|Participant Flow|Sham Comparator|Procedure: Standard of care laser photocoagulation
347930|NCT00344968|O3|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
347931|NCT00344968|O2|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
347932|NCT00344968|O1|Outcome|Sham Comparator|Procedure: Standard of care laser photocoagulation
347933|NCT00344968|O3|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
347934|NCT00344968|O2|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
347935|NCT00344968|O1|Outcome|Sham Comparator|Procedure: Standard of care laser photocoagulation
347936|NCT00344968|E3|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
347937|NCT00344968|E2|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
347938|NCT00344968|E1|Reported Event|Sham Comparator|Standard of care laser photocoagulation
347939|NCT00345033|B3|Baseline|Total|Total of all reporting groups
347940|NCT00345033|B2|Baseline|Placebo|Participants will take placebo for 8 weeks.
347941|NCT00345033|B1|Baseline|Aripiprazole|Participants will take aripiprazole for 8 weeks.
347942|NCT00345033|P2|Participant Flow|Placebo|Participants will take placebo for 8 weeks.
347943|NCT00345033|P1|Participant Flow|Aripiprazole|Participants will take aripiprazole for 8 weeks.
347944|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
347945|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
347946|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
347947|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
347948|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
347949|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
347950|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
347951|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
347952|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
347953|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
347954|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
347955|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
347956|NCT00345033|E2|Reported Event|Placebo|Participants will take placebo for 8 weeks.
347957|NCT00345033|E1|Reported Event|Aripiprazole|Participants will take aripiprazole for 8 weeks.
347958|NCT00345046|B4|Baseline|Total|Total of all reporting groups
347959|NCT00345046|B3|Baseline|Prednisolone Acetate|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
347960|NCT00345046|B2|Baseline|EconoPred Plus|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
347961|NCT00345046|B1|Baseline|Pred Forte|"Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
Pred Forte: Four drops daily decreasing to once daily over four weeks."
347962|NCT00345046|P3|Participant Flow|Prednisolone Acetate 1%|Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
347963|NCT00345046|P2|Participant Flow|EconPred Plus 1%|EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
347964|NCT00345046|P1|Participant Flow|Pred Forte 1%|Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
347965|NCT00345046|O3|Outcome|Predisolone Acetate 1%|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
347966|NCT00345046|O2|Outcome|Econo Pred Plus 1%|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
347967|NCT00345046|O1|Outcome|Pred Forte 1%|Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
347968|NCT00345046|E3|Reported Event|Prednisolone Acetate 1%|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
347969|NCT00345046|E2|Reported Event|EconoPred Plus 1%|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
347970|NCT00345046|E1|Reported Event|Pred Forte 1%|"Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
Pred Forte: Four drops daily decreasing to once daily over four weeks."
347971|NCT00345176|B5|Baseline|Total|Total of all reporting groups
347972|NCT00345176|B4|Baseline|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
347973|NCT00345176|B3|Baseline|DHA/EPA|DHA (350 mg)/EPA (650 mg)
347974|NCT00345176|B2|Baseline|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
347975|NCT00345176|B1|Baseline|Placebo/Control|Considered control because all participants received the AREDS formulation
347976|NCT00345176|P4|Participant Flow|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
347977|NCT00345176|P3|Participant Flow|DHA/EPA|DHA (350 mg)/EPA (650 mg)
347978|NCT00345176|P2|Participant Flow|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
347979|NCT00345176|P1|Participant Flow|Placebo/Control|Considered control because all participants received the AREDS formulation
347980|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|Lutein main effect - includes all participants who received Lutein/Zeaxanthin
347981|NCT00345176|O1|Outcome|No Lutein/Zeaxanthin|Lutein main effect - includes participants who did not receive Lutein/Zeaxanthin
347982|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
347983|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
347985|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
347986|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
347987|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
347988|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
347989|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
347990|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
347991|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
347992|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
347993|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
347994|NCT00345176|E4|Reported Event|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
347995|NCT00345176|E3|Reported Event|DHA/EPA|DHA (350 mg)/EPA (650 mg)
347996|NCT00345176|E2|Reported Event|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
347997|NCT00345176|E1|Reported Event|Placebo/Control|Considered control because all participants received the AREDS formulation
347998|NCT00345254|B3|Baseline|Total|Total of all reporting groups
347999|NCT00345254|B2|Baseline|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
348000|NCT00345254|B1|Baseline|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
348001|NCT00345254|P2|Participant Flow|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
351565|NCT00355082|B3|Baseline|Total|Total of all reporting groups
348002|NCT00345254|P1|Participant Flow|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
348003|NCT00345254|O2|Outcome|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
348004|NCT00345254|O1|Outcome|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
348005|NCT00345254|E2|Reported Event|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
348006|NCT00345254|E1|Reported Event|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
348007|NCT00345293|B1|Baseline|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
348008|NCT00345293|P2|Participant Flow|DC/PC3- Adherent|3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using the adherence method.
348009|NCT00345293|P1|Participant Flow|DC/PC3 Vaccine-selected|3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using antibodies.
348010|NCT00345293|O1|Outcome|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
348011|NCT00345293|O2|Outcome|DC/PC3- Adherent|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).
Dendritic cells were made from the adherent subset of peripheral blood mononuclear cells."
348012|NCT00345293|O1|Outcome|DC/PC3 Vaccine- Selected|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).
Dendritic cells were made from antibody selected cells."
348050|NCT00345397|O2|Outcome|SCI-Specific QoL Evaluation in Subjects Receiving PEC Tube|SCI-Specific QoL evaluation before and after device placement
348051|NCT00345397|O1|Outcome|Global SCI-QoL Score in Subjects Receiving PEC Tube|Global SCI-QoL Score before and after device placement
348052|NCT00345397|E1|Reported Event|Subjects Receiving PEC Tube|QoL evaluation before and after device placement
348013|NCT00345293|O1|Outcome|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
348014|NCT00345293|E1|Reported Event|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
348015|NCT00345332|B3|Baseline|Total|Total of all reporting groups
348016|NCT00345332|B2|Baseline|Botox Group|BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
348017|NCT00345332|B1|Baseline|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
348018|NCT00345332|P2|Participant Flow|Botox Group|Botox (BTX) was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
348091|NCT00345605|B1|Baseline|High-dose Arginine vs Low-dose Arginine Plus Buphenyl|
348019|NCT00345332|P1|Participant Flow|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
348020|NCT00345332|O2|Outcome|Botox Group|BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
348021|NCT00345332|O1|Outcome|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
348022|NCT00345332|O2|Outcome|Botox Group|BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
348023|NCT00345332|O1|Outcome|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
348024|NCT00345332|E2|Reported Event|Botox Group|BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
348025|NCT00345332|E1|Reported Event|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
348026|NCT00345371|B3|Baseline|Total|Total of all reporting groups
348027|NCT00345371|B2|Baseline|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet"
348028|NCT00345371|B1|Baseline|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate"
348029|NCT00345371|P2|Participant Flow|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet"
348030|NCT00345371|P1|Participant Flow|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate"
348031|NCT00345371|O2|Outcome|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet"
348032|NCT00345371|O1|Outcome|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate"
348033|NCT00345371|O2|Outcome|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet"
348034|NCT00345371|O1|Outcome|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate"
348035|NCT00345371|E2|Reported Event|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet"
348036|NCT00345371|E1|Reported Event|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate"
348037|NCT00345384|B3|Baseline|Total|Total of all reporting groups
348038|NCT00345384|B2|Baseline|Dexmedetomidine|titrated IV for 24 hours post ICU
348039|NCT00345384|B1|Baseline|Normal Saline|Standard of care
348040|NCT00345384|P2|Participant Flow|Dexmedetomidine|Received Dexmedetomidine for 24 hours
348041|NCT00345384|P1|Participant Flow|Normal Saline|Blinded Normal saline infusion titrated as if study drug
348042|NCT00345384|O2|Outcome|Dexmedetomidine|"Study group to receive a continuous infusion of dexmedetomidine titrated from 0.1 - 0.5 mics/kg/h to control pain for up to 30 hours after they are admitted to an open nursing unit after discharge from the PACU or ICU
Dexmedetomidine: Dexmedetomidine titrated over 24 hours"
348043|NCT00345384|O1|Outcome|Placebo|Control group to receive a normal saline infusion, set at a rate as if it were the active drug.
348044|NCT00345384|O2|Outcome|Dexmedetomidine|Patient group to receive Dexmedetomidine.
348045|NCT00345384|O1|Outcome|Placebo|Patient group to receive placebo (saline).
348046|NCT00345384|E2|Reported Event|Study Drug Group|Dexmedetomidine titrated IV from 0.1 microgram/kg/h upto 0.5 microgram/kg/h to control pain for 24 hours post ICU
348047|NCT00345384|E1|Reported Event|Normal Saline Group|Normal saline infused at calculated rate as if it were study drug
348048|NCT00345397|B1|Baseline|Subjects Receiving Percutaneous Endoscopic Colostomy (PEC)|Quality of Life (QOL) evaluation before and after device placement
348049|NCT00345397|P1|Participant Flow|Subjects Receiving PEC Tube|All Enrolled Subjects receiving PEC Placement
348127|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
348053|NCT00345540|B1|Baseline|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
348054|NCT00345540|P1|Participant Flow|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
348055|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
348056|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
348057|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
348058|NCT00345540|E1|Reported Event|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
348059|NCT00345579|B3|Baseline|Total|Total of all reporting groups
348060|NCT00345579|B2|Baseline|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348061|NCT00345579|B1|Baseline|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348062|NCT00345579|P2|Participant Flow|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348063|NCT00345579|P1|Participant Flow|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348064|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348065|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348066|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348067|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348068|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348069|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348070|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348128|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
348129|NCT00351741|E2|Reported Event|Conventional|Low-tidal volume ventilation
348130|NCT00351741|E1|Reported Event|High Frequency|Intervention with high frequency percussive ventilation
348071|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348072|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348073|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348074|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348092|NCT00345605|P2|Participant Flow|Low Dose First|low dose arm 3 day wash-out followed by 7 days of: Arg 100 mg/kg/d or 2 g/m2 BSA NaPBA 500 mg/kg/d or 10 g/m2 BSA interval then: Arg 500 mg/kg/d or 10 g/m2 BSA Placebo instead of NaPBA
348075|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348076|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348077|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348078|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348079|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348080|NCT00345579|E2|Reported Event|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348081|NCT00345579|E1|Reported Event|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
348082|NCT00345592|B3|Baseline|Total|Total of all reporting groups
348083|NCT00345592|B2|Baseline|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.
Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device
Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
348084|NCT00345592|B1|Baseline|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
348085|NCT00345592|P2|Participant Flow|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.
Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device
Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
348086|NCT00345592|P1|Participant Flow|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
348087|NCT00345592|O2|Outcome|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.
Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device
Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
348088|NCT00345592|O1|Outcome|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
348089|NCT00345592|E2|Reported Event|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.
Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device
Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
348090|NCT00345592|E1|Reported Event|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
348093|NCT00345605|P1|Participant Flow|High Dose First|High dose arm 3 day wash-out followed by 7 days of: Arg 500 mg/kg/d or 10 g/m2 BSA Placebo instead of NaPBA interval then: Arg 100 mg/kg/d or 2 g/m2 BSA NaPBA 500 mg/kg/d or 10 g/m2 BSA
348094|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
348095|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
348096|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
348097|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
348098|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
348099|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
348100|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
348101|NCT00345605|O1|Outcome|High-dose Arginine Alone|
348102|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
348103|NCT00345605|O1|Outcome|High-dose Arginine Alone|
348104|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
348105|NCT00345605|O1|Outcome|High-dose Arginine Alone|
348106|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
348107|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
348108|NCT00345605|E2|Reported Event|Low-dose Arginine Plus Buphenyl|
348109|NCT00345605|E1|Reported Event|High-dose Arginine Alone|
348110|NCT00351741|B3|Baseline|Total|Total of all reporting groups
348111|NCT00351741|B2|Baseline|Conventional|Low-tidal volume ventilation
348112|NCT00351741|B1|Baseline|High Frequency|Intervention with high frequency percussive ventilation
348113|NCT00351741|P2|Participant Flow|Conventional|Low-tidal volume ventilation
348114|NCT00351741|P1|Participant Flow|High Frequency|Intervention with high frequency percussive ventilation
348115|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
348116|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
348117|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
348118|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
348119|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
348120|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
348121|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
348122|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
348123|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
348124|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
348125|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
348126|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
348132|NCT00351819|B2|Baseline|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348133|NCT00351819|B1|Baseline|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348134|NCT00351819|P2|Participant Flow|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348135|NCT00351819|P1|Participant Flow|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348136|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348137|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348138|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348139|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348140|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348141|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348142|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348143|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348144|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348189|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
348145|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348146|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348147|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348148|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348149|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348150|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348151|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348152|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348153|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348154|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348155|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348156|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348157|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348158|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348159|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348160|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348161|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348162|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348163|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348164|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348165|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348166|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348167|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348168|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348169|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348170|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348171|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348172|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348173|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348174|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
350640|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
348175|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348176|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348177|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348178|NCT00351819|O2|Outcome|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348179|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348180|NCT00351819|E2|Reported Event|Placebo|"Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
348181|NCT00351819|E1|Reported Event|Androgel (Testosterone Gel)|"Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
348182|NCT00352365|B1|Baseline|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
348183|NCT00352365|P1|Participant Flow|Lenalidomide|Induction Therapy: Oral lenalidomide once daily on days 1-14, 1-21, or 1-28. Maintenance Therapy: Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
348184|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
348185|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
348186|NCT00352365|O2|Outcome|Nonresponders|Eligible and evaluable patients who did not achieve CR/CRi/PR
348187|NCT00352365|O1|Outcome|Responders|Eligible and evaluable patients who achieved CR/CRi/PR
348188|NCT00352365|O2|Outcome|Maintenance Therapy|Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
348190|NCT00352365|E2|Reported Event|Maintenance Therapy|Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
348191|NCT00352365|E1|Reported Event|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
348192|NCT00352417|B3|Baseline|Total|Total of all reporting groups
348193|NCT00352417|B2|Baseline|Matching Placebo|Placebo Dose
348194|NCT00352417|B1|Baseline|VIA-2291|100-mg dose
348195|NCT00352417|P2|Participant Flow|Matching Placebo|Placebo Dose
348196|NCT00352417|P1|Participant Flow|VIA-2291|100-mg dose
348197|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
348198|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
348199|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
348200|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
348201|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
348202|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
348203|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
348204|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
348205|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
348206|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
348207|NCT00352417|E2|Reported Event|Matching Placebo|Placebo Dose
348208|NCT00352417|E1|Reported Event|VIA-2291|100-mg dose
348209|NCT00352534|B3|Baseline|Total|Total of all reporting groups
348210|NCT00352534|B2|Baseline|Stage III|Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.
348211|NCT00352534|B1|Baseline|Stage I or II|Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment.
348212|NCT00352534|P7|Participant Flow|High Risk|Treatment arm. High risk.
348213|NCT00352534|P6|Participant Flow|Standard Risk, Stage III|Treatment arm. Standard Risk, Stage III.
348214|NCT00352534|P5|Participant Flow|Standard Risk, Stage I or II With LOH|Treatment arm. Standard Risk, Stage I or II with LOH.
348215|NCT00352534|P4|Participant Flow|Low Risk, Stage I or II, no LOH|Treatment arm. Low risk, stage I or II, no loss of heterozygosity (LOH).
348216|NCT00352534|P3|Participant Flow|Very Low Risk Disease|Treatment arm. Nephrectomy and re-evaluation,very low-risk disease.
348217|NCT00352534|P2|Participant Flow|Stage III|Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.
348218|NCT00352534|P1|Participant Flow|Stage I/II|Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment
348219|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
348220|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
348221|NCT00352534|O3|Outcome|Standard Risk, Stage III|Standard Risk, Stage III
348222|NCT00352534|O2|Outcome|Standard Risk, Stage I or II, With LOH|Standard Risk, Stage I or II, with LOH
348223|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
348224|NCT00352534|O3|Outcome|Standard Risk, Stage III|Standard Risk, Stage III
348225|NCT00352534|O2|Outcome|Standard Risk, Stage I or II, With LOH|Standard Risk, Stage I or II, with LOH
348226|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
348227|NCT00352534|E5|Reported Event|High Risk|High risk.
348228|NCT00352534|E4|Reported Event|Standard Risk, Stage III|Nephrectomy/Biopsy, Chemotherapy
348229|NCT00352534|E3|Reported Event|Standard Risk, Stage I or II, With LOH|Standard Risk, Stage I or II, with loss of heterozygosity (LOH).
348230|NCT00352534|E2|Reported Event|Low Risk, Stage I or II, no LOH|Low risk, stage I or II, no loss of heterozygosity (LOH).
348231|NCT00352534|E1|Reported Event|Very Low Risk Disease|Nephrectomy and Re-evaluation
348232|NCT00352612|B3|Baseline|Total|Total of all reporting groups
348233|NCT00352612|B2|Baseline|Group 2|clindamycin arm
348234|NCT00352612|B1|Baseline|Group 1|cephalexin arm
348235|NCT00352612|P2|Participant Flow|Clindamycin|those who received clindamycin
348236|NCT00352612|P1|Participant Flow|Cephalexin|patients who received cephalexin
348237|NCT00352612|O2|Outcome|Clindamycin|those patients who received clindamycin
348238|NCT00352612|O1|Outcome|Cephalexin|those patients who received cephalexin
348245|NCT00352664|P1|Participant Flow|Donepezil|Oral Donepezil 5 mg daily x 7 days
348246|NCT00352664|O2|Outcome|Placebo|Oral Placebo tablet daily x 7 days
348247|NCT00352664|O1|Outcome|Donepezil|Oral Donepezil 5 mg daily x 7 days
348248|NCT00352664|E2|Reported Event|Placebo|Oral Placebo tablet daily x 7 days
348249|NCT00352664|E1|Reported Event|Donepezil|Oral Donepezil 5 mg daily x 7 days
348250|NCT00352690|B3|Baseline|Total|Total of all reporting groups
348251|NCT00352690|B2|Baseline|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348252|NCT00352690|B1|Baseline|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348253|NCT00352690|P2|Participant Flow|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348254|NCT00352690|P1|Participant Flow|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348255|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348256|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348257|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348258|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348259|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348260|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348261|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348316|NCT00353119|O1|Outcome|Etanercept After Placebo|Group 1 patients that crossed over to etanercept 50mg twice weekly for weeks 12 to 24 after having initiated the study with placebo for the first 12 weeks
348377|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
348262|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348263|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348264|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348265|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348266|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348267|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348268|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348269|NCT00352690|E2|Reported Event|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348270|NCT00352690|E1|Reported Event|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
348271|NCT00352755|B1|Baseline|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy
IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
348272|NCT00352755|P1|Participant Flow|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy
IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
348273|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy
IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
348274|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy
IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
348317|NCT00353119|O1|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
348378|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
348379|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
348275|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy
IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
348276|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy
IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
348277|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy
IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
348278|NCT00352755|E1|Reported Event|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy
IP 5FU 600 mg/m2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m2 over 2 hours with leucovorin at 400 mg/m2 and IV 5-FU at 2400 mg/m2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
348279|NCT00352781|B1|Baseline|Nicotine Replacement Therapy (NRT)|Open-label Nicotine Replacement Therapy + counseling
348280|NCT00352781|P1|Participant Flow|Nicotine Replacement Therapy + Counseling|Up to 10 weeks of open-label nicotine replacement therapy (as per product monograph) + counseling
348281|NCT00352781|O1|Outcome|Nicotine Replacement Therapy|Open-label nicotine replacement therapy (as per product monograph) plus counseling
348282|NCT00352781|O1|Outcome|Nicotine Replacement Therapy|Open-label nicotine replacement therapy (as per product monograph) plus counseling
348283|NCT00352781|E1|Reported Event|Nicotine Replacement Therapy + Counseling|Up to 10 weeks of open-label nicotine replacement therapy + counseling
348284|NCT00352846|B3|Baseline|Total|Total of all reporting groups
348285|NCT00352846|B2|Baseline|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
348286|NCT00352846|B1|Baseline|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
348287|NCT00352846|P2|Participant Flow|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
348288|NCT00352846|P1|Participant Flow|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
348289|NCT00352846|O2|Outcome|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
348290|NCT00352846|O1|Outcome|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
348291|NCT00352846|E2|Reported Event|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
348292|NCT00352846|E1|Reported Event|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
348293|NCT00352885|B3|Baseline|Total|Total of all reporting groups
348294|NCT00352885|B2|Baseline|Placebo|Participants will receive placebo and IL-2 treatment
348295|NCT00352885|B1|Baseline|Escitalopram|Participants will receive escitalopram and IL-2 treatment
348296|NCT00352885|P2|Participant Flow|Placebo|Participants will receive placebo 2 weeks before and during IL-2 treatment
348297|NCT00352885|P1|Participant Flow|Escitalopram|Participants will receive escitalopram 10-20 mg/day 2 weeks before and during IL-2 treatment
348298|NCT00352885|O2|Outcome|Placebo|Participants will receive placebo and IL-2 treatment
348299|NCT00352885|O1|Outcome|Escitalopram|Participants will receive escitalopram and IL-2 treatment
348300|NCT00352885|E2|Reported Event|Placebo|Participants will receive placebo and IL-2 treatment
348301|NCT00352885|E1|Reported Event|Escitalopram|Participants will receive escitalopram and IL-2 treatment
348302|NCT00352911|B3|Baseline|Total|Total of all reporting groups
348303|NCT00352911|B2|Baseline|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
348304|NCT00352911|B1|Baseline|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
348305|NCT00352911|P2|Participant Flow|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
348306|NCT00352911|P1|Participant Flow|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
348307|NCT00352911|O2|Outcome|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
348308|NCT00352911|O1|Outcome|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
348309|NCT00352911|E2|Reported Event|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
348310|NCT00352911|E1|Reported Event|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
348311|NCT00353119|B3|Baseline|Total|Total of all reporting groups
348312|NCT00353119|B2|Baseline|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
348313|NCT00353119|B1|Baseline|Placebo Then Etanercept|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24
348314|NCT00353119|P2|Participant Flow|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
348315|NCT00353119|P1|Participant Flow|Placebo Then Etanercept|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24
348318|NCT00353119|O2|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND Patients that crossed over to etanercept 50 mg subcutanously twice weekly after taking placebo for the first 12 weeks.
348319|NCT00353119|O1|Outcome|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1
348320|NCT00353119|O2|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
348321|NCT00353119|O1|Outcome|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1
348322|NCT00353119|E2|Reported Event|Etanercept|Patients randomized to etanercept who received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND patients who crossed over to etanercept 50 mg subcutaneously twice a week for 12 weeks.
348323|NCT00353119|E1|Reported Event|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks
348324|NCT00353262|B1|Baseline|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348387|NCT00353431|P1|Participant Flow|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
348325|NCT00353262|P1|Participant Flow|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348326|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348327|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348328|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348329|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348368|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
348369|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
348370|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
348371|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
348372|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
348373|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
348374|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
348375|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
348330|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348331|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348414|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
348332|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348333|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348334|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348335|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348336|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348337|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348338|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348339|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348340|NCT00353262|E1|Reported Event|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
348341|NCT00353275|B3|Baseline|Total|Total of all reporting groups
348342|NCT00353275|B2|Baseline|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
348343|NCT00353275|B1|Baseline|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
348344|NCT00353275|P2|Participant Flow|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
348345|NCT00353275|P1|Participant Flow|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
348346|NCT00353275|O2|Outcome|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
348347|NCT00353275|O1|Outcome|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
348348|NCT00353275|E2|Reported Event|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
348349|NCT00353275|E1|Reported Event|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
348350|NCT00353301|B1|Baseline|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
348351|NCT00353301|P1|Participant Flow|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
348352|NCT00353301|O1|Outcome|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
348353|NCT00353301|O1|Outcome|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
348354|NCT00353301|E1|Reported Event|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
348355|NCT00353366|B1|Baseline|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
348356|NCT00353366|P1|Participant Flow|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
348357|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
348358|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
348359|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
348360|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
348361|NCT00353366|E1|Reported Event|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
348362|NCT00353418|B3|Baseline|Total|Total of all reporting groups
348363|NCT00353418|B2|Baseline|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
348364|NCT00353418|B1|Baseline|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
348365|NCT00353418|P2|Participant Flow|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
348366|NCT00353418|P1|Participant Flow|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
348367|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
348381|NCT00353418|E2|Reported Event|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
348382|NCT00353418|E1|Reported Event|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
348383|NCT00353431|B3|Baseline|Total|Total of all reporting groups
348384|NCT00353431|B2|Baseline|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
348385|NCT00353431|B1|Baseline|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
348386|NCT00353431|P2|Participant Flow|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
348415|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
348388|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
348389|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
348390|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
348391|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
348392|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
348393|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
348394|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
348395|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
348396|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
348397|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
348398|NCT00353431|E2|Reported Event|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
348399|NCT00353431|E1|Reported Event|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
348400|NCT00353496|B3|Baseline|Total|Total of all reporting groups
348401|NCT00353496|B2|Baseline|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
348402|NCT00353496|B1|Baseline|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
348403|NCT00353496|P2|Participant Flow|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
349489|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
348404|NCT00353496|P1|Participant Flow|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
348405|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
348406|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
348407|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
348408|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
348409|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
348410|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
348411|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
348412|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
348413|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
348416|NCT00353496|E2|Reported Event|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
348417|NCT00353496|E1|Reported Event|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
348418|NCT00353652|B7|Baseline|Total|Total of all reporting groups
348419|NCT00353652|B6|Baseline|Spironolactone|Spironolactone: 25-75 mg taken orally, once daily
348420|NCT00353652|B5|Baseline|Chlorthalidone|Chlorthalidone: 12.5-25 mg taken orally, once daily
348421|NCT00353652|B4|Baseline|Irbesartan|"Drug: Irbesartan
150 mg taken orally, once daily"
348422|NCT00353652|B3|Baseline|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily
Irbesartan: 150 mg taken orally, once daily"
348423|NCT00353652|B2|Baseline|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily
Spironolactone: 50-75 mg taken orally, once daily"
348424|NCT00353652|B1|Baseline|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
348425|NCT00353652|P6|Participant Flow|Spironolactone|Spironolactone 25-75 mg taken orally daily
348426|NCT00353652|P5|Participant Flow|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally daily
348427|NCT00353652|P4|Participant Flow|Irbesartan|"Drug: Irbesartan
150 mg taken orally, once daily"
348428|NCT00353652|P3|Participant Flow|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily
Irbesartan: 150 mg taken orally, once daily"
348429|NCT00353652|P2|Participant Flow|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily
Spironolactone: 50-75 mg taken orally, once daily"
348430|NCT00353652|P1|Participant Flow|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
348431|NCT00353652|O6|Outcome|Irbesartan|Irbesartan 150 mg taken orally once a day
348432|NCT00353652|O5|Outcome|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally
348433|NCT00353652|O4|Outcome|Spironolactone|Spironolactone 25-50 mg taken orally daily
348434|NCT00353652|O3|Outcome|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily
Irbesartan: 150 mg taken orally, once daily"
348435|NCT00353652|O2|Outcome|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily
Spironolactone: 50-75 mg taken orally, once daily"
348436|NCT00353652|O1|Outcome|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
348437|NCT00353652|E6|Reported Event|Spironolactone|Spironolactone 25-75 mg taken orally daily
348438|NCT00353652|E5|Reported Event|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally daily
348439|NCT00353652|E4|Reported Event|Irbesartan|Drug: Irbesartan 150 mg taken orally, once daily
348440|NCT00353652|E3|Reported Event|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily
Irbesartan: 150 mg taken orally, once daily"
348441|NCT00353652|E2|Reported Event|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily
Spironolactone: 50-75 mg taken orally, once daily"
348442|NCT00353652|E1|Reported Event|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
348443|NCT00353704|B3|Baseline|Total|Total of all reporting groups
348444|NCT00353704|B2|Baseline|Placebo|
348445|NCT00353704|B1|Baseline|Pregabalin|
348446|NCT00353704|P2|Participant Flow|Placebo|
348447|NCT00353704|P1|Participant Flow|Pregabalin|
348448|NCT00353704|O2|Outcome|Placebo|
348449|NCT00353704|O1|Outcome|Pregabalin|
348450|NCT00353704|O2|Outcome|Placebo|
348451|NCT00353704|O1|Outcome|Pregabalin|
348452|NCT00353704|E2|Reported Event|Placebo|
348453|NCT00353704|E1|Reported Event|Pregabalin|
348454|NCT00353795|B1|Baseline|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
348455|NCT00353795|P1|Participant Flow|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
348513|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348456|NCT00353795|O1|Outcome|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
348457|NCT00353795|E1|Reported Event|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
348458|NCT00353873|B3|Baseline|Total|Total of all reporting groups
348459|NCT00353873|B2|Baseline|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348460|NCT00353873|B1|Baseline|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348461|NCT00353873|P2|Participant Flow|Salmeterol/Fluticasone Propionate (SFC) 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348462|NCT00353873|P1|Participant Flow|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348463|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348464|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348465|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348466|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348467|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348468|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348469|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348470|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348471|NCT00353873|E2|Reported Event|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348472|NCT00353873|E1|Reported Event|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
348473|NCT00353977|B1|Baseline|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
348474|NCT00353977|P1|Participant Flow|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
348475|NCT00353977|O1|Outcome|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
348476|NCT00353977|E1|Reported Event|Alvac pp65 Vaccine|Subjects received 1, 2 or 3 doses of the vaccine
348477|NCT00354029|B3|Baseline|Total|Total of all reporting groups
348478|NCT00354029|B2|Baseline|Placebo|
348479|NCT00354029|B1|Baseline|S (+) Ketamine|
348480|NCT00354029|P2|Participant Flow|Placebo|
348481|NCT00354029|P1|Participant Flow|S (+) Ketamine|
348482|NCT00354029|O2|Outcome|Placebo|
348483|NCT00354029|O1|Outcome|S (+) Ketamine|
348484|NCT00354029|E2|Reported Event|Placebo|
348485|NCT00354029|E1|Reported Event|S (+) Ketamine|
348486|NCT00354107|B1|Baseline|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).
Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
348487|NCT00354107|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).
Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
348525|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
348526|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348763|NCT00354835|O2|Outcome|VAC (Weeks 31 - 43)|Reporting period 3 (late)
348488|NCT00354107|O1|Outcome|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).
Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
348489|NCT00354107|E1|Reported Event|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).
Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
348490|NCT00354159|B3|Baseline|Total|Total of all reporting groups
348491|NCT00354159|B2|Baseline|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348492|NCT00354159|B1|Baseline|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348493|NCT00354159|P2|Participant Flow|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348494|NCT00354159|P1|Participant Flow|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348495|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348496|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348497|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348498|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348499|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system
348500|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system
348501|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348502|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348503|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348504|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348505|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348506|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348507|NCT00354159|O2|Outcome|Heart Failure Event Control Subjects|Subjects randomized to the Control Arm that had a heart failure event during the 12-month randomized period
348508|NCT00354159|O1|Outcome|Heart Failure Event Free Control Subjects|Subjects randomized to the Control Arm that did not have a heart failure related event during the 12-month randomized period
348509|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348510|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348511|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348512|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348514|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348515|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348516|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348517|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348518|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348519|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
348520|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348521|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
348522|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348523|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
348524|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348764|NCT00354835|O1|Outcome|VAC (Weeks 1-15)|Reporting period 1 (acute)
348527|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
348528|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348529|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348530|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348531|NCT00354159|O1|Outcome|Chronicle IHM Implanted Subjects|Analysis cohort includes the one subject with a Chronicle IHM implant attempt
348532|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.
348533|NCT00354159|E3|Reported Event|Enrolled, Not Randomized|42 subjects were enrolled but exited the study prior to randomization
348534|NCT00354159|E2|Reported Event|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
348535|NCT00354159|E1|Reported Event|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
348536|NCT00354172|B1|Baseline|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348537|NCT00354172|P1|Participant Flow|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348538|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348539|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348540|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348541|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348542|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348543|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348544|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348545|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348546|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348547|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348548|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348549|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348550|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348551|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348552|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348553|NCT00354172|E1|Reported Event|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
348554|NCT00354341|B3|Baseline|Total|Total of all reporting groups
348555|NCT00354341|B2|Baseline|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
348556|NCT00354341|B1|Baseline|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
348557|NCT00354341|P2|Participant Flow|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was less than (<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
348579|NCT00354432|P3|Participant Flow|Arm III - Venlafaxine|Patients receive oral venlafaxine pill and oral placebo powder once daily.
348580|NCT00354432|P2|Participant Flow|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
352338|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
348558|NCT00354341|P1|Participant Flow|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
348559|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
348560|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
348561|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
348562|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
348563|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
348564|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
348565|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
348566|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
348567|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
348568|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
348569|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
348570|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
348571|NCT00354341|E2|Reported Event|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
348572|NCT00354341|E1|Reported Event|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
348573|NCT00354432|B5|Baseline|Total|Total of all reporting groups
348574|NCT00354432|B4|Baseline|Arm IV - Soy + Venlafaxine|Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
348575|NCT00354432|B3|Baseline|Arm III - Venlafaxine|Patients receive oral venlafaxine pill and oral placebo powder once daily.
348576|NCT00354432|B2|Baseline|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
348577|NCT00354432|B1|Baseline|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
348578|NCT00354432|P4|Participant Flow|Arm IV - Soy + Venlafaxin|Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
348581|NCT00354432|P1|Participant Flow|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
348582|NCT00354432|O4|Outcome|Arm IV - Soy + Venlafaxine|Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
348583|NCT00354432|O3|Outcome|Arm III - Venlafaxine|Patients receive oral Venlafaxine pill and placebo powder once daily.
348584|NCT00354432|O2|Outcome|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
348585|NCT00354432|O1|Outcome|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
348586|NCT00354432|O4|Outcome|Arm IV - Soy + Venlafaxine|Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
348587|NCT00354432|O3|Outcome|Arm III - Venlafaxine|Patients receive oral Venlafaxine pill and placebo powder once daily.
348588|NCT00354432|O2|Outcome|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
348589|NCT00354432|O1|Outcome|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
348590|NCT00354432|E4|Reported Event|Arm IV - Soy + Venlafaxine|Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
348591|NCT00354432|E3|Reported Event|Arm III - Venlafaxine|Patients receive oral Venlafaxine pill and placebo powder once daily.
348592|NCT00354432|E2|Reported Event|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
348593|NCT00354432|E1|Reported Event|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
348594|NCT00354484|B3|Baseline|Total|Total of all reporting groups
348595|NCT00354484|B2|Baseline|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
348596|NCT00354484|B1|Baseline|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
348597|NCT00354484|P2|Participant Flow|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
348598|NCT00354484|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
348599|NCT00354484|O2|Outcome|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
348600|NCT00354484|O1|Outcome|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
348601|NCT00354484|E2|Reported Event|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
348602|NCT00354484|E1|Reported Event|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
348603|NCT00354601|B1|Baseline|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
348604|NCT00354601|P1|Participant Flow|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
348605|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
348606|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
348607|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
348608|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
348609|NCT00354601|E1|Reported Event|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
348610|NCT00354614|B1|Baseline|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
348611|NCT00354614|P1|Participant Flow|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
348612|NCT00354614|O1|Outcome|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
348613|NCT00354614|E1|Reported Event|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
348645|NCT00348673|P1|Participant Flow|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348614|NCT00354640|B1|Baseline|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis
pharmacological study : laboratory analysis
simvastatin : 40 milligram tablet PO QD for 14 days
anastrozole : 1 milligram tablet PO QD for 14 days"
348615|NCT00354640|P1|Participant Flow|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis
pharmacological study : laboratory analysis
simvastatin : 40 milligram tablet PO QD for 14 days
anastrozole : 1 milligram tablet PO QD for 14 days"
348616|NCT00354640|O1|Outcome|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis
pharmacological study : laboratory analysis
simvastatin : 40 milligram tablet PO QD for 14 days
anastrozole : 1 milligram tablet PO QD for 14 days"
348617|NCT00354640|O1|Outcome|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis
pharmacological study : laboratory analysis
simvastatin : 40 milligram tablet PO QD for 14 days
anastrozole : 1 milligram tablet PO QD for 14 days"
348618|NCT00354640|E1|Reported Event|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis
pharmacological study : laboratory analysis
simvastatin : 40 milligram tablet PO QD for 14 days
anastrozole : 1 milligram tablet PO QD for 14 days"
348619|NCT00354679|B1|Baseline|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
348620|NCT00354679|P1|Participant Flow|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
348621|NCT00354679|O1|Outcome|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
348757|NCT00354835|O2|Outcome|UGT1A1 Genotype 6/7|
348622|NCT00354679|E1|Reported Event|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
348623|NCT00348556|B1|Baseline|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
348624|NCT00348556|P1|Participant Flow|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
348625|NCT00348556|O1|Outcome|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
348626|NCT00348556|O1|Outcome|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
348627|NCT00348556|E1|Reported Event|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
348628|NCT00348673|B9|Baseline|Total|Total of all reporting groups
348629|NCT00348673|B8|Baseline|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348630|NCT00348673|B7|Baseline|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
348631|NCT00348673|B6|Baseline|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348632|NCT00348673|B5|Baseline|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
348633|NCT00348673|B4|Baseline|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
348634|NCT00348673|B3|Baseline|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348635|NCT00348673|B2|Baseline|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348636|NCT00348673|B1|Baseline|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348637|NCT00348673|P9|Participant Flow|Placebo Once/Twice Daily (Stage 2)|Three placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348638|NCT00348673|P8|Participant Flow|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
348639|NCT00348673|P7|Participant Flow|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348640|NCT00348673|P6|Participant Flow|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
348641|NCT00348673|P5|Participant Flow|Placebo Once/Twice Daily (Stage 1)|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348642|NCT00348673|P4|Participant Flow|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
348643|NCT00348673|P3|Participant Flow|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348644|NCT00348673|P2|Participant Flow|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
349490|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
348646|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
348647|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348648|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
348649|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
348650|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348651|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348652|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348653|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
348758|NCT00354835|O1|Outcome|UGT1A1 Genotype 6/6|
348654|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348655|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
348656|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
348657|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348658|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348659|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348660|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
348661|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348662|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
348663|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
348664|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348665|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348666|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348667|NCT00348673|O8|Outcome|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348668|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
348669|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348670|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
348671|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
348672|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348673|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348674|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348675|NCT00348673|O8|Outcome|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348676|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
348730|NCT00348933|E1|Reported Event|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
348677|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348678|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
348679|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
348680|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348681|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348682|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348683|NCT00348673|E8|Reported Event|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348759|NCT00354835|O2|Outcome|% Change in SUVmax From Baseline to Week 15 >= 40%|
348684|NCT00348673|E7|Reported Event|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
348685|NCT00348673|E6|Reported Event|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
348686|NCT00348673|E5|Reported Event|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
348687|NCT00348673|E4|Reported Event|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
348688|NCT00348673|E3|Reported Event|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348689|NCT00348673|E2|Reported Event|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348690|NCT00348673|E1|Reported Event|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
348691|NCT00348686|B1|Baseline|Candesartan|
348692|NCT00348686|P1|Participant Flow|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
348693|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
348694|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
348695|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
348696|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
348697|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
348698|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
348699|NCT00348686|E1|Reported Event|Candesartan|
348700|NCT00348790|B1|Baseline|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months."
348701|NCT00348790|P1|Participant Flow|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months."
348702|NCT00348790|O1|Outcome|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months."
348703|NCT00348790|O1|Outcome|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months."
348799|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
348704|NCT00348790|E1|Reported Event|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
vatalanib"
348705|NCT00348816|B1|Baseline|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Adjuvant therapy: radical prostatectomy as part of standard care
Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
348706|NCT00348816|P1|Participant Flow|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Adjuvant therapy: radical prostatectomy as part of standard care
Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
348707|NCT00348816|O1|Outcome|Docetaxel (Single Arm)|Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD. Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
348708|NCT00348816|O1|Outcome|Docetaxel (Single Arm)|Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD. Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
348709|NCT00348816|E1|Reported Event|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Adjuvant therapy: radical prostatectomy as part of standard care
Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
348710|NCT00348881|B3|Baseline|Total|Total of all reporting groups
348711|NCT00348881|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
348712|NCT00348881|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
348713|NCT00348881|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
348714|NCT00348881|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
348715|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
348716|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
348717|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
348718|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
348719|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/Hib™ Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
348720|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP-T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
348721|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with OPV vaccines at 6, 10 and 14 weeks of age.
348722|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
348723|NCT00348881|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
348724|NCT00348881|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
348725|NCT00348933|B1|Baseline|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
348726|NCT00348933|P1|Participant Flow|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
348727|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betaine/B12)|
348728|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betain/B12)|All participants received treatment. Compared to a placebo group from a previous study.
348729|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betaine/B12)|
348800|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
348731|NCT00354744|B1|Baseline|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
348732|NCT00354744|P1|Participant Flow|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
348760|NCT00354835|O1|Outcome|% Change in SUVmax From Baseline to Week 15 < 40%|
348761|NCT00354835|O2|Outcome|% Change in SUVmax From Baseline to Week 4 >= 40%|
348762|NCT00354835|O1|Outcome|% Change in SUVmax From Baseline to Week 4 < 40%|
348733|NCT00354744|O1|Outcome|High_Risk_Rhabdomyosarcoma|Patients with parameningeal (without intracranial extension) and paraspinal tumors should receive chemotherapy beginning Week 1 and begin radiation therapy at Week 20. Weeks 1-6 vincristine sulfate (VCR) & irinotecan hydrochloride (IRIN), Weeks 7-34 vincristine sulfate (VCR), Cyclophosphamide (CPM) with MESNA, Doxorubicin hydrochloride (DOX), Etoposide (ETOP), Ifosfamide (IFOS) with MESNA. Weeks 35-54 vincristine sulfate (VCR), Dactinomycin (DACT) and Cyclophosphamide (CPM) with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
348734|NCT00354744|O1|Outcome|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients
348735|NCT00354744|E1|Reported Event|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
348736|NCT00354770|B3|Baseline|Total|Total of all reporting groups
348737|NCT00354770|B2|Baseline|Placebo|Placebo pills
348738|NCT00354770|B1|Baseline|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
348739|NCT00354770|P2|Participant Flow|Placebo|Placebo pills
348740|NCT00354770|P1|Participant Flow|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
348741|NCT00354770|O2|Outcome|Placebo|Placebo pills
348742|NCT00354770|O1|Outcome|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
348743|NCT00354770|E2|Reported Event|Placebo|Placebo pills
348744|NCT00354770|E1|Reported Event|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
348745|NCT00354835|B3|Baseline|Total|Total of all reporting groups
348746|NCT00354835|B2|Baseline|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348747|NCT00354835|B1|Baseline|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348748|NCT00354835|P2|Participant Flow|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348749|NCT00354835|P1|Participant Flow|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|"Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies"
348750|NCT00354835|O2|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
349491|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
348751|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348752|NCT00354835|O2|Outcome|PAX7|Fusion positive with PAX7 partner
348753|NCT00354835|O1|Outcome|PAX3|Fusion positive with PAX3 partner
348754|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|
348755|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348756|NCT00354835|O3|Outcome|UGT1A1 Genotype 7/7|
348765|NCT00354835|O2|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348766|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348767|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348768|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348769|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348770|NCT00354835|O2|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348771|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348772|NCT00354835|O2|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348773|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
348774|NCT00354835|O2|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
350641|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
348775|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|"Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies"
348776|NCT00354835|E2|Reported Event|VAC Alternating With VI|"Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Irinotecan Hydrochloride: Given IV
Dactinomycin: Given IV
Cyclophosphamide: Given IV
Vincristine Sulfate: Given IV
Radiation Therapy: Undergo radiotherapy
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies"
348807|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
348808|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
348865|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
348777|NCT00354835|E1|Reported Event|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|"Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Dactinomycin: Given IV
Cyclophosphamide: Given IV
Vincristine Sulfate: Given IV
Radiation Therapy: Undergo radiotherapy
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies"
348778|NCT00354887|B1|Baseline|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
348779|NCT00354887|P1|Participant Flow|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
348780|NCT00354887|O1|Outcome|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
348781|NCT00354887|E1|Reported Event|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
348782|NCT00354913|B1|Baseline|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
348783|NCT00354913|P1|Participant Flow|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
348784|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
348785|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
348786|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
348787|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
348788|NCT00354913|E1|Reported Event|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
348789|NCT00354978|B1|Baseline|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
348790|NCT00354978|P1|Participant Flow|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
348791|NCT00354978|O1|Outcome|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
348792|NCT00354978|E1|Reported Event|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
348793|NCT00355030|B3|Baseline|Total|Total of all reporting groups
348794|NCT00355030|B2|Baseline|Somatropin|0.05mg/kg/day subcutaneous somatropin only
348795|NCT00355030|B1|Baseline|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
348796|NCT00355030|P2|Participant Flow|Somatropin: Experimental Arm 2|0.05mg/kg/day subcutaneous somatropin only
348797|NCT00355030|P1|Participant Flow|Somatropin and Leuprorelin: Experimental Arm 1|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
348798|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
350642|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
348801|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
348802|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
348803|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
348804|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
348805|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
348806|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
348863|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
348864|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
348809|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
348810|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
348811|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
348812|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
348813|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
348814|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
348815|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
348816|NCT00355030|E2|Reported Event|Somatropin|Somatropin n=45
348817|NCT00355030|E1|Reported Event|Somatropin and Leuprorelin|Somatropin and leuprorelin n=46
348818|NCT00357110|B3|Baseline|Total|Total of all reporting groups
348819|NCT00357110|B2|Baseline|Anastrozole|anastrozole 1 mg
348820|NCT00357110|B1|Baseline|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
348821|NCT00357110|P2|Participant Flow|Anastrozole|anastrozole 1 mg
348822|NCT00357110|P1|Participant Flow|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
348823|NCT00357110|O2|Outcome|Anastrozole|anastrozole 1 mg
348824|NCT00357110|O1|Outcome|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
348825|NCT00357110|E2|Reported Event|Anastrozole|anastrozole 1 mg
348826|NCT00357110|E1|Reported Event|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
348827|NCT00357162|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
348828|NCT00357162|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
348829|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
348830|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
348831|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
348832|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
348833|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
348834|NCT00357162|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
348835|NCT00357331|B3|Baseline|Total|Total of all reporting groups
348836|NCT00357331|B2|Baseline|Potassium Citrate|
348837|NCT00357331|B1|Baseline|Placebo|
348838|NCT00357331|P2|Participant Flow|Placebo|"Placebo
Placebo 20 meq by mouth in capsule form twice daily"
348839|NCT00357331|P1|Participant Flow|Potassium Citrate|"Potassium Citrate 20 meq twice daily
potassium citrate: 20 meq by mouth in capsule form twice daily"
348840|NCT00357331|O2|Outcome|Potassium Citrate|
348841|NCT00357331|O1|Outcome|Placebo|
348842|NCT00357331|O2|Outcome|Potassium Citrate|
348843|NCT00357331|O1|Outcome|Placebo|
348844|NCT00357331|O2|Outcome|Potassium Citrate|
348845|NCT00357331|O1|Outcome|Placebo|
348846|NCT00357331|E2|Reported Event|Placebo|"Placebo
potassium citrate: 20 meq by mouth in capsule form twice daily"
348847|NCT00357331|E1|Reported Event|Potassium Citrate|"Potassium Citrate 20 meq twice daily
potassium citrate: 20 meq by mouth in capsule form twice daily"
348848|NCT00357370|B4|Baseline|Total|Total of all reporting groups
348849|NCT00357370|B3|Baseline|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
348850|NCT00357370|B2|Baseline|Placebo|Tablets, oral, once daily for 12 weeks
348851|NCT00357370|B1|Baseline|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
348852|NCT00357370|P3|Participant Flow|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
348853|NCT00357370|P2|Participant Flow|Placebo|Tablets, oral, once daily for 12 weeks
348854|NCT00357370|P1|Participant Flow|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
348855|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
348856|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
348857|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
348858|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
348859|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
348860|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
348861|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
348862|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
348866|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
348867|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
348868|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
348869|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
348870|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
348871|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
348872|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
348873|NCT00357370|E3|Reported Event|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
348874|NCT00357370|E2|Reported Event|Placebo|Tablets, oral, once daily for 12 weeks
348875|NCT00357370|E1|Reported Event|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
348876|NCT00357396|B3|Baseline|Total|Total of all reporting groups
348877|NCT00357396|B2|Baseline|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
348878|NCT00357396|B1|Baseline|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
348879|NCT00357396|P2|Participant Flow|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
348880|NCT00357396|P1|Participant Flow|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
348881|NCT00357396|O1|Outcome|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
348882|NCT00357396|E2|Reported Event|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
348883|NCT00357396|E1|Reported Event|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
348884|NCT00357500|B1|Baseline|5-drug Metronmic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
348885|NCT00357500|P1|Participant Flow|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
348886|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
348990|NCT00357877|O1|Outcome|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
348887|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
348888|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
348919|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
348889|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
348890|NCT00357500|E1|Reported Event|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
348891|NCT00357552|B1|Baseline|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
348892|NCT00357552|P1|Participant Flow|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
348893|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
348894|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
348895|NCT00357552|O1|Outcome|LPV/r Monotherapy|"Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) once a day will be added to their regimen.
Emtricitabine/Tenofovir disoproxil fumarate: Once daily
Lopinavir/Ritonavir: Twice daily"
348896|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
348897|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
348898|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen. The study is ongoing. Results from entry to week 24 are posted. They will be updated upon completion of study duration of 104 weeks.
348899|NCT00357552|O1|Outcome|Virologic Failures by Week 24.|Subjects who met virologic failure criteria by week 24, for whom a sequence could be obtained.
348900|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
348901|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
348902|NCT00357552|O1|Outcome|All Screened Subjects With Available Sequences|All screened individuals, for whom a sequence could be obtained, regardless of whether they enrolled or not.
348903|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
348904|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
348905|NCT00357552|E1|Reported Event|LPV/r|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
348906|NCT00357656|B3|Baseline|Total|Total of all reporting groups
348907|NCT00357656|B2|Baseline|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
348908|NCT00357656|B1|Baseline|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
348909|NCT00357656|P2|Participant Flow|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
348910|NCT00357656|P1|Participant Flow|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
348911|NCT00357656|O3|Outcome|Safety Analysis Set|All participants treated with at least one ADVATE (rAHF-PFM) dose
348912|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
348913|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
348914|NCT00357656|O3|Outcome|Safety Analysis Set|All participants treated with at least one ADVATE (rAHF-PFM) dose.
348915|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
348916|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
348917|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
348918|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
349038|NCT00357955|B3|Baseline|Total|Total of all reporting groups
348920|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
348921|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
348922|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
348923|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
348924|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
348925|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
348926|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
348927|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
348928|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
348929|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
348930|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
348931|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of rAHF-PFM
348932|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of rAHF-PFM
348933|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
348934|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
348935|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
348936|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
348937|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
348938|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
348939|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
348940|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
348941|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
348942|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
348943|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
348944|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
348945|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
348946|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
348947|NCT00357656|O2|Outcome|Contiuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
348948|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
348949|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
348950|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
348951|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
348952|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
348953|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
348954|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
348955|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
348956|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
348957|NCT00357656|E3|Reported Event|Not Assigned Participants|All participants who were not assigned to either bolus infusion or continuous infusion but received at least one ADVATE (rAHF-PFM) dose during pharmacokinetic evaluation. A total of 9 participants received only the pharmacokinetic infusion and were not randomized.
348958|NCT00357656|E2|Reported Event|Continuous Infusion|All participants who were randomized to receive continuous infusion (CI) of ADVATE (rAHF-PFM). At total of 32 participants were randomized and received at least one ADVATE (rAHF-PFM) dose.
348959|NCT00357656|E1|Reported Event|Bolus Infusion|All participants who were randomized to receive bolus infusion (BI) of ADVATE (rAHF-PFM). At total of 31 participants were randomized and received at least one ADVATE (rAHF-PFM) dose.
348960|NCT00357734|B1|Baseline|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
348961|NCT00357734|P1|Participant Flow|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
348962|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
348963|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
348964|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
348965|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
348966|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
348967|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
348968|NCT00357734|E1|Reported Event|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
348969|NCT00357760|B3|Baseline|Total|Total of all reporting groups
348970|NCT00357760|B2|Baseline|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
348971|NCT00357760|B1|Baseline|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
348972|NCT00357760|P2|Participant Flow|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
348973|NCT00357760|P1|Participant Flow|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
348974|NCT00357760|O2|Outcome|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
348975|NCT00357760|O1|Outcome|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
348976|NCT00357760|O2|Outcome|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
348977|NCT00357760|O1|Outcome|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
348978|NCT00357760|O2|Outcome|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
348979|NCT00357760|O1|Outcome|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
348980|NCT00357760|E2|Reported Event|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
348981|NCT00357760|E1|Reported Event|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
348982|NCT00357877|B3|Baseline|Total|Total of all reporting groups
348983|NCT00357877|B2|Baseline|Active Dental Coating|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition
348984|NCT00357877|B1|Baseline|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
348985|NCT00357877|P2|Participant Flow|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
348986|NCT00357877|P1|Participant Flow|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
348987|NCT00357877|O2|Outcome|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
348988|NCT00357877|O1|Outcome|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
348989|NCT00357877|O2|Outcome|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
348991|NCT00357877|O2|Outcome|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
348992|NCT00357877|O1|Outcome|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
348993|NCT00357877|O2|Outcome|Active|Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
348994|NCT00357877|O1|Outcome|Placebo|Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
348995|NCT00357877|E2|Reported Event|Active|Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
348996|NCT00357877|E1|Reported Event|Placebo|Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
348997|NCT00357903|B3|Baseline|Total|Total of all reporting groups
348998|NCT00357903|B2|Baseline|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
348999|NCT00357903|B1|Baseline|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349000|NCT00357903|P2|Participant Flow|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349039|NCT00357955|B2|Baseline|Usual Care|usual care
352339|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
349001|NCT00357903|P1|Participant Flow|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349002|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349003|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349004|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349005|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349006|NCT00357903|O1|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349007|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349008|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349009|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349010|NCT00357903|O1|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349011|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349012|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349013|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349014|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349015|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349016|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349017|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349018|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349019|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349020|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349021|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349022|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349023|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349024|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349025|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349026|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349027|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349492|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
349028|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349029|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349030|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349031|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349032|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349033|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349034|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
349035|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
349036|NCT00357903|E2|Reported Event|Pediatric Subjects|
349037|NCT00357903|E1|Reported Event|Total Adults|
349040|NCT00357955|B1|Baseline|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction
Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms
Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention
Role modeling : learning from peers with similar disease and problems
Interactive Education : interactive lectures with hands-on learning"
349041|NCT00357955|P2|Participant Flow|Usual Care|usual care
349042|NCT00357955|P1|Participant Flow|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction
Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms
Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention
Role modeling : learning from peers with similar disease and problems
Interactive Education : interactive lectures with hands-on learning"
349043|NCT00357955|O2|Outcome|Usual Care|The standard of care to patients with type 2 diabetes is provided by primary care providers at the VA Medical Center through individual clinic visits. The frequency of these visits for patients with diabetes averages approximately 4 months.usual care
349044|NCT00357955|O1|Outcome|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction
Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention
Interactive Education: interactive lectures with hands-on learning
Role modeling: learning from peers with similar disease and problems
Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms"
349045|NCT00357955|E2|Reported Event|Usual Care|usual care
349046|NCT00357955|E1|Reported Event|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction
Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention
Interactive Education: interactive lectures with hands-on learning
Role modeling: learning from peers with similar disease and problems
Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms"
349047|NCT00357968|B3|Baseline|Total|Total of all reporting groups
349048|NCT00357968|B2|Baseline|Clopidogrel to Prasugrel|One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) for 14 days. Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
349049|NCT00357968|B1|Baseline|Prasugrel to Clopidogrel|One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days. Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
349050|NCT00357968|P2|Participant Flow|Clopidogrel to Prasugrel|One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
349051|NCT00357968|P1|Participant Flow|Prasugrel to Clopidogrel|One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
349052|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
349053|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
349173|NCT00358150|E1|Reported Event|Eliglustat 50 mg BID|Participants who received eliglustat capsule as single 50 mg dose on Day 1 followed by eliglustat 50 mg BID from Day 2 to Year 9.
349054|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
349055|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
349056|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
349057|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
349058|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
349059|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
349296|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349060|NCT00357968|O2|Outcome|Clopidogrel|Includes total number of evaluable samples from patients who received clopidogrel in each maintenance dose period (52 from the first maintenance dose period and 51 from the second maintenance dose period).
349061|NCT00357968|O1|Outcome|Prasugrel|Includes the total number of evaluable samples from patients who received prasugrel in each maintenance dose period (50 from the first maintenance dose period and 50 from the second maintenance dose period)
349062|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
349063|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
349064|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose.
349065|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose
349066|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose.
349067|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
349068|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
349069|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
349070|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
349071|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
349072|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
349073|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
349074|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) for the next 14 days.
349075|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) for the next 14 days.
349174|NCT00358215|B3|Baseline|Total|Total of all reporting groups
349493|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
349076|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
349077|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
349078|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
349079|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
349426|NCT00358644|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
349080|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
349081|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
349082|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
349083|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
349084|NCT00357968|O2|Outcome|Clopidogrel|Includes total number of evaluable samples from patients who received clopidogrel in each maintenance dose period (46 from the first maintenance dose period and 40 from the second maintenance dose period).
349085|NCT00357968|O1|Outcome|Prasugrel|Includes total number of evaluable samples from patients who received prasugrel in each maintenance dose period (40 in the first maintenance period and 45 in the second maintenance period).
349086|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
349087|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
349088|NCT00357968|E4|Reported Event|Clopidogrel After Cross-over|Clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days after cross-over from one time loading dose of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10 mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
349089|NCT00357968|E3|Reported Event|Prasugrel After Cross-over|Prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose)once daily for 14 days after cross-over from one time loading dose of clopidogrel 600 mg and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days
349090|NCT00357968|E2|Reported Event|Clopidogrel Before Cross-over|One time oral loading dose of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days.
349091|NCT00357968|E1|Reported Event|Prasugrel Before Cross-over|One time oral loading dose (LD) of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
349092|NCT00357994|B3|Baseline|Total|Total of all reporting groups
349093|NCT00357994|B2|Baseline|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349094|NCT00357994|B1|Baseline|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349095|NCT00357994|P2|Participant Flow|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349096|NCT00357994|P1|Participant Flow|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349097|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349098|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349099|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349100|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349101|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349180|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
349102|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349103|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349104|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349105|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349106|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349107|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349108|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349109|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349110|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349111|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349112|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349113|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349114|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349115|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349116|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349117|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349118|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349119|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349120|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349121|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349122|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349123|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349124|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349125|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349126|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349127|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349128|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349129|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349130|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349131|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349132|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349133|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349134|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349135|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349136|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349137|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349138|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349139|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349140|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349141|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349142|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349143|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349144|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349145|NCT00357994|E2|Reported Event|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
349146|NCT00357994|E1|Reported Event|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
349147|NCT00358007|B1|Baseline|Cone Beam CT|Undergo a cone beam CT scan
349148|NCT00358007|P1|Participant Flow|Cone Beam CT|Undergo a cone beam CT scan
349149|NCT00358007|O1|Outcome|Cone Beam CT|PTV Reduction: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
349150|NCT00358007|O1|Outcome|Cone Beam CT|PTV Reduction: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
349151|NCT00358007|E1|Reported Event|Cone Beam CT|Undergo a cone beam CT scan
349152|NCT00358150|B1|Baseline|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349153|NCT00358150|P1|Participant Flow|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 milligram (mg) dose on Day 1 then eliglustat 50 mg twice daily (BID) from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 nanogram per milliliter [ng/mL] on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme), and if all other causes for lack of treatment effect had been evaluated and ruled out).
349154|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349155|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349175|NCT00358215|B2|Baseline|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
349176|NCT00358215|B1|Baseline|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
349585|NCT00359216|B3|Baseline|Total|Total of all reporting groups
349156|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 8. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349181|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
349182|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
349157|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349158|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349159|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349160|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349161|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349162|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349163|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349164|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349165|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349166|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349167|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349168|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349169|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349170|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
349171|NCT00358150|E3|Reported Event|Eliglustat|Participants who received eliglustat capsule as a single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID or eliglustat 100 mg BID from Day 20 to Year 9. Participants who discontinued prior to Day 20 dose had their dose group set to missing and are only included in the all participants group. The Eliglustat group contains all participants who were treated with Eliglustat, including 2 participants dosed with 50 mg QD and 1 participant dosed with 150 mg BID for majority of study. Participants who had dose adjustment will be presented in dose group they received for majority of study.
349172|NCT00358150|E2|Reported Event|Eliglustat 100 mg BID|Participants who received eliglustat capsule as single 50 mg dose on Day 1 followed by eliglustat 50 mg capsule BID from Day 2 to Day 19 and then eliglustat 100 mg capsule BID from Day 20 to Year 9.
349177|NCT00358215|P2|Participant Flow|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
349178|NCT00358215|P1|Participant Flow|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
349179|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
349295|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349183|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
349184|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
349185|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
349186|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
349187|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
349188|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
349189|NCT00358215|E2|Reported Event|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
349190|NCT00358215|E1|Reported Event|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
349191|NCT00358332|B5|Baseline|Total|Total of all reporting groups
349192|NCT00358332|B4|Baseline|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349193|NCT00358332|B3|Baseline|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349194|NCT00358332|B2|Baseline|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349195|NCT00358332|B1|Baseline|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349196|NCT00358332|P4|Participant Flow|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349197|NCT00358332|P3|Participant Flow|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349198|NCT00358332|P2|Participant Flow|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349199|NCT00358332|P1|Participant Flow|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349200|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349201|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349202|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349203|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349204|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349205|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349206|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349207|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349208|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349209|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349210|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349211|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349212|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349213|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349214|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349510|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
349215|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349216|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349217|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349218|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349219|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349220|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349221|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349222|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349223|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349224|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349225|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349226|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349227|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349228|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349229|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349230|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349231|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349232|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349233|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349234|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349235|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349236|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349237|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349238|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349239|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349240|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349488|NCT00358826|P1|Participant Flow|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
349241|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349242|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349243|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349244|NCT00358332|E4|Reported Event|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
349245|NCT00358332|E3|Reported Event|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349246|NCT00358332|E2|Reported Event|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349247|NCT00358332|E1|Reported Event|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
349248|NCT00358436|B3|Baseline|Total|Total of all reporting groups
349249|NCT00358436|B2|Baseline|Placebo|Placebo by inhalation
349250|NCT00358436|B1|Baseline|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
349251|NCT00358436|P2|Participant Flow|Placebo|Placebo by inhalation
349252|NCT00358436|P1|Participant Flow|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
349253|NCT00358436|O2|Outcome|Placebo|Once daily administered via inhalation
349254|NCT00358436|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
349255|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
349256|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
349257|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
349258|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
349259|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
349260|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
349261|NCT00358436|E2|Reported Event|Placebo|Placebo by inhalation
349262|NCT00358436|E1|Reported Event|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
349263|NCT00358449|B4|Baseline|Total|Total of all reporting groups
349264|NCT00358449|B3|Baseline|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349265|NCT00358449|B2|Baseline|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349266|NCT00358449|B1|Baseline|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
349267|NCT00358449|P3|Participant Flow|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349268|NCT00358449|P2|Participant Flow|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349269|NCT00358449|P1|Participant Flow|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
349270|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349271|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349272|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349273|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349274|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349275|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349276|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349277|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349278|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349279|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349280|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349281|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349282|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349283|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349284|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349285|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349286|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
350643|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
349287|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349288|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349289|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349290|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349291|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349292|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349293|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349294|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349297|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349298|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349299|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349300|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349301|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349302|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349303|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349304|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349305|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349306|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349307|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349308|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349309|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349310|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349311|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349312|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349313|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349314|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349315|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349316|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349317|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349318|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349319|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349320|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349321|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349322|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349323|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349324|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349325|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349326|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349327|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349328|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349329|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349330|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
350644|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
349331|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349332|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349333|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349334|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349335|NCT00358449|O1|Outcome|Mepolizumab 0.55/ 2.5/ 10 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349336|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349337|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349338|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349339|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349340|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349341|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349342|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349343|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349344|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349345|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349346|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349347|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349348|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349349|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349350|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349351|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349352|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349353|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349354|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349355|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349356|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349357|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349358|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349359|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349360|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349361|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349362|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349363|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349364|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349365|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
349366|NCT00358449|E3|Reported Event|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349367|NCT00358449|E2|Reported Event|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
349368|NCT00358449|E1|Reported Event|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
349369|NCT00358462|B3|Baseline|Total|Total of all reporting groups
349370|NCT00358462|B2|Baseline|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
349371|NCT00358462|B1|Baseline|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
349372|NCT00358462|P2|Participant Flow|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
349373|NCT00358462|P1|Participant Flow|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
349374|NCT00358462|O2|Outcome|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
350645|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
349375|NCT00358462|O1|Outcome|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
349376|NCT00358462|O2|Outcome|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
349377|NCT00358462|O1|Outcome|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
349378|NCT00358462|E2|Reported Event|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
349379|NCT00358462|E1|Reported Event|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
349380|NCT00358501|B3|Baseline|Total|Total of all reporting groups
349381|NCT00358501|B2|Baseline|Historical Control|The control group was selected from the historical medical charts of patients undergoing hematopoietic stem cell transplant (HSCT).
349382|NCT00358501|B1|Baseline|Defibrotide|"Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
349383|NCT00358501|P2|Participant Flow|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
349427|NCT00358644|E1|Reported Event|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
349384|NCT00358501|P1|Participant Flow|Defibrotide|"Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
349385|NCT00358501|O1|Outcome|Historical Control|
349386|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
349387|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
349388|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
349389|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
349390|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
349391|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
349392|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
349393|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
349394|NCT00358501|E2|Reported Event|Historical Control|
349395|NCT00358501|E1|Reported Event|Defibrotide|"Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
349396|NCT00358527|B3|Baseline|Total|Total of all reporting groups
349397|NCT00358527|B2|Baseline|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
349398|NCT00358527|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
349399|NCT00358527|P2|Participant Flow|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
349400|NCT00358527|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
349401|NCT00358527|O2|Outcome|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
349402|NCT00358527|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
349403|NCT00358527|O2|Outcome|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
349404|NCT00358527|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
349405|NCT00358527|E2|Reported Event|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
349406|NCT00358527|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
349407|NCT00358579|B3|Baseline|Total|Total of all reporting groups
349408|NCT00358579|B2|Baseline|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349409|NCT00358579|B1|Baseline|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349410|NCT00358579|P2|Participant Flow|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349411|NCT00358579|P1|Participant Flow|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349412|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349413|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349414|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349415|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349416|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349417|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
350646|NCT00359801|E2|Reported Event|Non-Exubera®|Usual diabetes care
349418|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349419|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349420|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349421|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349422|NCT00358579|E2|Reported Event|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349423|NCT00358579|E1|Reported Event|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
349424|NCT00358644|B1|Baseline|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
349425|NCT00358644|P1|Participant Flow|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
349428|NCT00358670|B3|Baseline|Total|Total of all reporting groups
349429|NCT00358670|B2|Baseline|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
349430|NCT00358670|B1|Baseline|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
349431|NCT00358670|P2|Participant Flow|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in Psoriasis Area and Severity Index (PASI) from the Study P04271 (NCT00251641) Baseline
349432|NCT00358670|P1|Participant Flow|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
349433|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
349434|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
349435|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
349436|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
349437|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
349438|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
349439|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
349440|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
349441|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
349442|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
349443|NCT00358670|E2|Reported Event|Intermittent Infliximab|
349444|NCT00358670|E1|Reported Event|Maintenance Infliximab|
349445|NCT00358735|B3|Baseline|Total|Total of all reporting groups
349446|NCT00358735|B2|Baseline|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349447|NCT00358735|B1|Baseline|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349448|NCT00358735|P2|Participant Flow|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349449|NCT00358735|P1|Participant Flow|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349450|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349451|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349452|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349453|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349454|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349455|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349456|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349457|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349458|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349459|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349460|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349461|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349462|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349463|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349464|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349465|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349466|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349467|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349468|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349469|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349470|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349471|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349472|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349473|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349474|NCT00358735|E2|Reported Event|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
349475|NCT00358735|E1|Reported Event|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
349476|NCT00358826|B5|Baseline|Total|Total of all reporting groups
349477|NCT00358826|B4|Baseline|Placebo|Matching Placebo, oral dosing, 12 weeks
349478|NCT00358826|B3|Baseline|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
349479|NCT00358826|B2|Baseline|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
349480|NCT00358826|B1|Baseline|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
349481|NCT00358826|P8|Participant Flow|Placebo MDCT Substudy|Matching Placebo, 24 weeks
349482|NCT00358826|P7|Participant Flow|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
349483|NCT00358826|P6|Participant Flow|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
349484|NCT00358826|P5|Participant Flow|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
349485|NCT00358826|P4|Participant Flow|Placebo|Matching Placebo, 12 weeks
349486|NCT00358826|P3|Participant Flow|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
349487|NCT00358826|P2|Participant Flow|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
349494|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
349495|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
349496|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
349497|NCT00358826|O4|Outcome|Placebo MDCT Substudy|Matching Placebo, oral dosing, 24 weeks
349498|NCT00358826|O3|Outcome|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
349499|NCT00358826|O2|Outcome|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
349500|NCT00358826|O1|Outcome|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
349501|NCT00358826|O4|Outcome|Placebo MDCT Substudy|Matching Placebo, oral dosing, 24 weeks
349502|NCT00358826|O3|Outcome|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
349503|NCT00358826|O2|Outcome|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
349504|NCT00358826|O1|Outcome|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
349505|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
349506|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
349507|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
349508|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
349509|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
349511|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
349512|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
349513|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
349514|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
349515|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
349516|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
349517|NCT00358826|E4|Reported Event|Placebo|Matching Placebo, oral dosing, 12 weeks
349518|NCT00358826|E3|Reported Event|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
349519|NCT00358826|E2|Reported Event|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
349520|NCT00358826|E1|Reported Event|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
349521|NCT00358917|B3|Baseline|Total|Total of all reporting groups
349522|NCT00358917|B2|Baseline|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
349523|NCT00358917|B1|Baseline|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
349524|NCT00358917|P2|Participant Flow|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 milligram (mg) twice daily (BID) tablet
349525|NCT00358917|P1|Participant Flow|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 milligram (mg) once daily (QD) tablet
349526|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
349527|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
349528|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet; 81% NNRTI-experienced, 45% PI-experienced (20% nelfinavir, 17% indinavir, 13% atazanavir).
349529|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet; 88% NNRTI-experienced, 47% PI-experienced (24% nelfinavir, 19% indinavir, 13% atazanavir).
349530|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
349531|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
349532|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
349533|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
349534|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
349535|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
349536|NCT00358917|E2|Reported Event|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
349537|NCT00358917|E1|Reported Event|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
349538|NCT00358956|B1|Baseline|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
349539|NCT00358956|P1|Participant Flow|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
349540|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
349541|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
349542|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
349543|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
349544|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
349545|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
349546|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
349547|NCT00358956|E1|Reported Event|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
349548|NCT00359021|B3|Baseline|Total|Total of all reporting groups
349549|NCT00359021|B2|Baseline|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
349550|NCT00359021|B1|Baseline|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
349616|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
351093|NCT00362466|B1|Baseline|Dasatinib|100 mg QD
349551|NCT00359021|P2|Participant Flow|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
349552|NCT00359021|P1|Participant Flow|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
349553|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
349554|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
349555|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
349556|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
349558|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
349559|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
349560|NCT00359021|E3|Reported Event|All Participants|Participants who received placebo or TMC125 in a previous DUET study (DUET Placebo + DUET TMC125).
349561|NCT00359021|E2|Reported Event|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
349562|NCT00359021|E1|Reported Event|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
349563|NCT00359138|B4|Baseline|Total|Total of all reporting groups
349564|NCT00359138|B3|Baseline|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349565|NCT00359138|B2|Baseline|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349566|NCT00359138|B1|Baseline|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349567|NCT00359138|P3|Participant Flow|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349568|NCT00359138|P2|Participant Flow|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349569|NCT00359138|P1|Participant Flow|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349570|NCT00359138|O3|Outcome|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349571|NCT00359138|O2|Outcome|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349572|NCT00359138|O1|Outcome|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349573|NCT00359138|E3|Reported Event|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349574|NCT00359138|E2|Reported Event|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349575|NCT00359138|E1|Reported Event|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
349576|NCT00359203|B3|Baseline|Total|Total of all reporting groups
349577|NCT00359203|B2|Baseline|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
349578|NCT00359203|B1|Baseline|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
349579|NCT00359203|P2|Participant Flow|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
349580|NCT00359203|P1|Participant Flow|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
349581|NCT00359203|O2|Outcome|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
349582|NCT00359203|O1|Outcome|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
349583|NCT00359203|E2|Reported Event|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
349584|NCT00359203|E1|Reported Event|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
349586|NCT00359216|B2|Baseline|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
349587|NCT00359216|B1|Baseline|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
349588|NCT00359216|P2|Participant Flow|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
349589|NCT00359216|P1|Participant Flow|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
349590|NCT00359216|O2|Outcome|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
349625|NCT00359281|O6|Outcome|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
352340|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
349591|NCT00359216|O1|Outcome|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
349592|NCT00359216|E2|Reported Event|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
349593|NCT00359216|E1|Reported Event|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
349594|NCT00359281|B10|Baseline|Total|Total of all reporting groups
349595|NCT00359281|B9|Baseline|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
349596|NCT00359281|B8|Baseline|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
349597|NCT00359281|B7|Baseline|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
349598|NCT00359281|B6|Baseline|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
349599|NCT00359281|B5|Baseline|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
349600|NCT00359281|B4|Baseline|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
349601|NCT00359281|B3|Baseline|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
349602|NCT00359281|B2|Baseline|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
349603|NCT00359281|B1|Baseline|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
349604|NCT00359281|P9|Participant Flow|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
349605|NCT00359281|P8|Participant Flow|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
349606|NCT00359281|P7|Participant Flow|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
349607|NCT00359281|P6|Participant Flow|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
349608|NCT00359281|P5|Participant Flow|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
349609|NCT00359281|P4|Participant Flow|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
349610|NCT00359281|P3|Participant Flow|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
349611|NCT00359281|P2|Participant Flow|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
349612|NCT00359281|P1|Participant Flow|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
349613|NCT00359281|O1|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
349614|NCT00359281|O1|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
349615|NCT00359281|O1|Outcome|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
349617|NCT00359281|O1|Outcome|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
349618|NCT00359281|O1|Outcome|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
349619|NCT00359281|O1|Outcome|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
349620|NCT00359281|O1|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
349621|NCT00359281|O1|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
349622|NCT00359281|O9|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
349623|NCT00359281|O8|Outcome|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
349624|NCT00359281|O7|Outcome|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
352341|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
349626|NCT00359281|O5|Outcome|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
349627|NCT00359281|O4|Outcome|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
349628|NCT00359281|O3|Outcome|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
349629|NCT00359281|O2|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
349630|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
349631|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
349632|NCT00359281|E9|Reported Event|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
349633|NCT00359281|E8|Reported Event|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
349634|NCT00359281|E7|Reported Event|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
349635|NCT00359281|E6|Reported Event|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
349636|NCT00359281|E5|Reported Event|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
349637|NCT00359281|E4|Reported Event|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
349638|NCT00359281|E3|Reported Event|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
349639|NCT00359281|E2|Reported Event|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
349640|NCT00359281|E1|Reported Event|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
349641|NCT00359424|B3|Baseline|Total|Total of all reporting groups
349642|NCT00359424|B2|Baseline|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349643|NCT00359424|B1|Baseline|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349644|NCT00359424|P2|Participant Flow|IV Rt-PA Alone|IV rt-PA alone (group one) received the standard dose (.9mg per kilogram with 10% as a bolus and the remainder as an infusion over 1 hour -maximum dose 90mg) of intravenous (IV) rt-PA alone.
349645|NCT00359424|P1|Participant Flow|Endovascular Therapy|Endovascular therapy (group two) received a lower dose (0.09mg per kg bolus and 0.54mg/kilogram infusion over 40 minutes, maximum dose 53.6mg) or after Amendment #5, a standard dose of IV rt-PA (.9mg/kg with 10% as a bolus and the remainder over one hour) and then underwent an angiogram test (cerebral angiography) right after the medicine was given to check for blood clots. If a clot was not seen, then no more treatment was given. If a clot was seen, the neurointerventionalist chose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that would be most effective in reopening the blocked artery.
349646|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349668|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349752|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349753|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349647|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349648|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349649|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349650|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349651|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349652|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349653|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349654|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349655|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349656|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349657|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349658|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349659|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349660|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349661|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349662|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349663|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349664|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349665|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349666|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349667|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349859|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349669|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349670|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349671|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
349672|NCT00359424|E2|Reported Event|IV Only|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
349673|NCT00359424|E1|Reported Event|Endovascular|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) rightafter the medicine is given to check for blood clots. If a clot is not seenthen no more treatment will be given. If a clot is seen, theneurointerventionalist will then choose (based on the location andextent of the blood clot) a protocol approved endovascular treatmentgiven directly in the brain artery that will be most effective inreopening the blocked artery.
349674|NCT00351936|B1|Baseline|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
349675|NCT00351936|P1|Participant Flow|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
349676|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
349677|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
349678|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
349679|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
349680|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
349681|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
349682|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
349683|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
349684|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
349685|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
349686|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
349687|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
349688|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
349689|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
349690|NCT00351936|E1|Reported Event|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
349691|NCT00352027|B1|Baseline|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349692|NCT00352027|P1|Participant Flow|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349749|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349750|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
350453|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
349693|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349694|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349695|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349696|NCT00352027|O8|Outcome|HOD99 - Grade 5|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
349697|NCT00352027|O7|Outcome|HOD99 - Grade 4|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
349698|NCT00352027|O6|Outcome|HOD99 - Grade 3|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
349699|NCT00352027|O5|Outcome|HOD99 - Grade 2|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
349700|NCT00352027|O4|Outcome|HOD05 - Grade 5|Participants in current study.
349701|NCT00352027|O3|Outcome|HOD05 - Grade 4|Participants in current study.
349702|NCT00352027|O2|Outcome|HOD05 - Grade 3|Participants in current study.
349703|NCT00352027|O1|Outcome|HOD05 - Grade 2|Participants in current study.
349704|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:
EITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).
Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
349705|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:
EITHER Ann Arbor stage IB and IIIA,
OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).
Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349706|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:
EITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).
Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
349707|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:
EITHER Ann Arbor stage IB and IIIA,
OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).
Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349708|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:
EITHER Ann Arbor stage IB and IIIA,
OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).
Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
349751|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349709|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:
EITHER Ann Arbor stage IB and IIIA,
OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).
Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349710|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349711|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349712|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349713|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349714|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349715|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349716|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349717|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349718|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349719|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349720|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349721|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349722|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349723|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349724|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
349725|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349726|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349727|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349728|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349729|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349730|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349731|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349732|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349733|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349734|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349735|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349736|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349737|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349738|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349739|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349740|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349741|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349742|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349743|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349744|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349745|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349746|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349747|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349748|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349754|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349755|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349756|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349757|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349758|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349759|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349760|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349761|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349762|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349763|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349764|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349765|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349766|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349767|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349768|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349769|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349770|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349771|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349772|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349773|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349774|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349775|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349776|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349777|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349778|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349779|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349780|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349781|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349782|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349783|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349784|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349785|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349786|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349787|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349788|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349789|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349790|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349791|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349792|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349793|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349794|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349795|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349796|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
349797|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349798|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349799|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
349800|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349801|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349802|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349803|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349804|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349805|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349806|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349807|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349808|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349809|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349810|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349811|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349812|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349813|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349814|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349815|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
352342|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
349816|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349817|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349818|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349819|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349820|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349821|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349822|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349823|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349824|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349825|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349826|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349827|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349828|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349829|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349830|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349831|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349832|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349833|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349834|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349835|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349836|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349837|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349838|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349839|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349840|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349841|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349842|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349843|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349844|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349845|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349846|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349847|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349848|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349849|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349850|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349851|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349852|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349853|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349854|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349855|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349856|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349857|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349858|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349860|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349861|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349862|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349863|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349864|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349865|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349866|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349867|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349868|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349869|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349870|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349871|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349872|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349873|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349874|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349875|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349876|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349877|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349878|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349879|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349880|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349881|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349882|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349883|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349884|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349885|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349886|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349887|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349888|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349889|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349890|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349891|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349892|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349893|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349894|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349895|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349896|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349897|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349898|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349899|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349900|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349901|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349902|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349903|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349904|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349905|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349906|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349907|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349908|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349909|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349910|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349911|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349912|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349913|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349914|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349915|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349916|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
350454|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
349917|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349918|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349919|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349920|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349921|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349922|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349923|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349924|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349925|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349926|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349927|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349928|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349929|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349930|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349931|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349932|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349933|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349934|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349935|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349936|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349937|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349938|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349939|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349940|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349941|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349942|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349943|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349944|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349945|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349946|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349947|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349948|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349949|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349950|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
349951|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
349952|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
349953|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
349954|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
349955|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349956|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349957|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349958|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349959|NCT00352027|E1|Reported Event|Stanford V Chemotherapy|"Intermediate risk single arm study defined as
EITHER Ann Arbor stage IB and IIIA,
OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).
Participants receive 12 weeks of Stanford V chemotherapy:
Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)
After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
349960|NCT00352053|B3|Baseline|Total|Total of all reporting groups
349961|NCT00352053|B2|Baseline|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
349962|NCT00352053|B1|Baseline|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
349963|NCT00352053|P2|Participant Flow|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
350389|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
349964|NCT00352053|P1|Participant Flow|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablets plus a genotype-guided optimized background regimen (OBR; 3 minimum (min.)/5 maximum (max.) antiretroviral agents (ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
349965|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
349966|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
349967|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349968|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349969|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
349970|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349971|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349972|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
349973|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349974|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349975|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
349976|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349977|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349978|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
349979|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350151|NCT00359619|B6|Baseline|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
349980|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349981|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
349982|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349983|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349984|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350390|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
349985|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349986|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349987|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
349988|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
349989|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349990|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349991|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
349992|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
349993|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349994|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349995|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
349996|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349997|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
349998|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
349999|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350000|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350455|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350001|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350002|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350003|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350004|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350005|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA >= 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350006|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350007|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350008|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350009|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350010|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350011|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350012|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350013|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350014|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350015|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350016|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350017|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350018|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350019|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350020|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350021|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350309|NCT00359736|E2|Reported Event|Sildenafil|sildenafil : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
350022|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350023|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350024|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350025|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350026|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350027|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350028|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350029|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350030|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350031|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350032|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350033|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350034|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350035|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350036|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350037|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350038|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350039|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350040|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350041|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350042|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350310|NCT00359736|E1|Reported Event|Placebo|Control group
350311|NCT00359762|B3|Baseline|Total|Total of all reporting groups
350456|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350043|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350044|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350045|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350046|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350349|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350047|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350048|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350049|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350050|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350051|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350052|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350053|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350054|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350055|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350056|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350057|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350058|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350059|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350060|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350061|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350062|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350063|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350312|NCT00359762|B2|Baseline|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350064|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350065|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350066|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350067|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350068|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350069|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350070|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350071|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350072|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350073|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350074|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350075|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350076|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350077|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350078|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350079|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350080|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350081|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350082|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350083|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350084|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350457|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350085|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350086|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350087|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350088|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350384|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350385|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350089|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350090|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350091|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350092|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350093|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350094|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350095|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350096|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350097|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350098|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350099|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350100|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350101|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350102|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350103|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350104|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350105|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350458|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350459|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350106|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350107|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350108|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350154|NCT00359619|B3|Baseline|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350109|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350110|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350111|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350112|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350113|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350114|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
350115|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350116|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350117|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350118|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350119|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350120|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
350121|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350122|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350123|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350124|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350125|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350126|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
350127|NCT00352053|E3|Reported Event|All TDF|"Adverse events reported for the All TDF group include those reported during the double-blind phase and/or extension phase for subjects who were randomized to TDF group plus adverse events reported during the extension phase only for subjects who switched from placebo to open-label TDF.
Tenofovir DF 300-mg tablets in participants initially randomized to the Tenofovir DF group, and in those initially randomized to the Placebo group who later switched to open-label TDF 300 mg."
350128|NCT00352053|E2|Reported Event|Placebo|"Adverse events occurring in the double-blind phase are presented for this reporting group.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks."
350386|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350387|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350129|NCT00352053|E1|Reported Event|Tenofovir DF|"Adverse events occurring in the double-blind phase are presented for this reporting group.
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks."
350130|NCT00352105|B1|Baseline|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
350131|NCT00352105|P1|Participant Flow|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
350132|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
350133|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
350134|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
350135|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
350136|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
350137|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
350138|NCT00352105|E1|Reported Event|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
350139|NCT00352118|B1|Baseline|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
350140|NCT00352118|P1|Participant Flow|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
350141|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
350142|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
350143|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
350144|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
350145|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
350146|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
350147|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
350148|NCT00352118|E1|Reported Event|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
350149|NCT00359619|B8|Baseline|Total|Total of all reporting groups
350150|NCT00359619|B7|Baseline|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350313|NCT00359762|B1|Baseline|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350152|NCT00359619|B5|Baseline|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350153|NCT00359619|B4|Baseline|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350348|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350155|NCT00359619|B2|Baseline|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350156|NCT00359619|B1|Baseline|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350157|NCT00359619|P7|Participant Flow|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350158|NCT00359619|P6|Participant Flow|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350159|NCT00359619|P5|Participant Flow|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350160|NCT00359619|P4|Participant Flow|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350161|NCT00359619|P3|Participant Flow|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350162|NCT00359619|P2|Participant Flow|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350163|NCT00359619|P1|Participant Flow|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350164|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350165|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350166|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350167|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350168|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350169|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350170|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350171|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350172|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350173|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350174|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350175|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350176|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350450|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350177|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350178|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350179|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350388|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350180|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350181|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350182|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350183|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350184|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350185|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350186|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350187|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350188|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350189|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350190|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350191|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350192|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350193|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350194|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350195|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350196|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350197|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350198|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350199|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350200|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350201|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350202|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350203|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350204|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350205|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350206|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350207|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350208|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350209|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350210|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350211|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350212|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350213|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350214|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350215|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350216|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350217|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350218|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350219|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350220|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350221|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350222|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350223|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350224|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350225|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350226|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350227|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350228|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350229|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350230|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350231|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350232|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350233|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350234|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350235|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350236|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350237|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350238|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350239|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350240|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350241|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350242|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350243|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350244|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350245|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350246|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350247|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350248|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350249|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350250|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350251|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350252|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350253|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350254|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350255|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350256|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350257|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350258|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350259|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350260|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350261|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350262|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350263|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350264|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350265|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350266|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350267|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350268|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350269|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350270|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350271|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350272|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350273|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350274|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350275|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350276|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350277|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350278|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350279|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350280|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350281|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350282|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350283|NCT00359619|E7|Reported Event|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350284|NCT00359619|E6|Reported Event|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350285|NCT00359619|E5|Reported Event|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350286|NCT00359619|E4|Reported Event|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350287|NCT00359619|E3|Reported Event|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350288|NCT00359619|E2|Reported Event|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350289|NCT00359619|E1|Reported Event|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
350290|NCT00359632|B3|Baseline|Total|Total of all reporting groups
350291|NCT00359632|B2|Baseline|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
350292|NCT00359632|B1|Baseline|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
350293|NCT00359632|P2|Participant Flow|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
350294|NCT00359632|P1|Participant Flow|Linezolid|Participants received linezolid either as tablets, by mouth (PO) or as an intravenous (IV) infusion at a dose of 600 milligrams (mg), twice daily (BID). Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
350295|NCT00359632|O1|Outcome|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
350296|NCT00359632|O2|Outcome|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
350297|NCT00359632|O1|Outcome|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
350298|NCT00359632|E2|Reported Event|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
350299|NCT00359632|E1|Reported Event|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
350300|NCT00359736|B3|Baseline|Total|Total of all reporting groups
350301|NCT00359736|B2|Baseline|Placebo|Identical Placebo: 20 mg TID orally
350302|NCT00359736|B1|Baseline|Sildenafil|Sildenafil 20 mg TID orally: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
350303|NCT00359736|P2|Participant Flow|Placebo|Control group: Identical Placebo 20 mg TID orally
350304|NCT00359736|P1|Participant Flow|Sildenafil|Sildenafil 20 mg TID orally : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
350305|NCT00359736|O2|Outcome|Placebo|Identical Placebo 20mg tid orally
350306|NCT00359736|O1|Outcome|Sildenafil|Sildenafil 20 mg tid orally
350307|NCT00359736|O2|Outcome|Placebo|Identical Placebo 20 mg tid
350308|NCT00359736|O1|Outcome|Sildenafil|"Sildenafil 20 mg tid
sildenafil: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients."
350460|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350314|NCT00359762|P5|Participant Flow|Period II, Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350315|NCT00359762|P4|Participant Flow|Period III, Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
350316|NCT00359762|P3|Participant Flow|Period III, Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
350317|NCT00359762|P2|Participant Flow|Period III, Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
350318|NCT00359762|P1|Participant Flow|Period II, Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350319|NCT00359762|O3|Outcome|Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
350320|NCT00359762|O2|Outcome|Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
350321|NCT00359762|O1|Outcome|Exen + Metformin + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
350322|NCT00359762|O1|Outcome|Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
350323|NCT00359762|O2|Outcome|Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
350324|NCT00359762|O1|Outcome|Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
350325|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350326|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350327|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350328|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350329|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350330|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350331|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350332|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350333|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350334|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350335|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350336|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350337|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350338|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350339|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350340|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350341|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350342|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350343|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350344|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350345|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350346|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350347|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350350|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350351|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350352|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350353|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350354|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350355|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350356|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350357|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350358|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350359|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350360|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350361|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350362|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350363|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350364|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350365|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350366|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350367|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350368|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350369|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350370|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350371|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350372|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350373|NCT00359762|E5|Reported Event|Period II, Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
350374|NCT00359762|E4|Reported Event|Period III, Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
350451|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350375|NCT00359762|E3|Reported Event|Period III, Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
350376|NCT00359762|E2|Reported Event|Period III, Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
350377|NCT00359762|E1|Reported Event|Period II, Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
350378|NCT00359788|B3|Baseline|Total|Total of all reporting groups
350379|NCT00359788|B2|Baseline|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350380|NCT00359788|B1|Baseline|Tiotropium|18 mcg once daily
350381|NCT00359788|P2|Participant Flow|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350382|NCT00359788|P1|Participant Flow|Tiotropium|18 mcg once daily
350383|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350391|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350392|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350393|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350394|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350395|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350396|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350397|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350398|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350399|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350400|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350401|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350402|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350403|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350404|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350405|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350406|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350407|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350408|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350409|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350410|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350411|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350412|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350413|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350414|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350415|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350416|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350417|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350418|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350419|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350420|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350421|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350422|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350423|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350424|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350425|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350426|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350427|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350428|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350429|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350430|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350431|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350432|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350433|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350434|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350435|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350436|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350437|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350438|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350439|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350440|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350441|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350442|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350443|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350444|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350445|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350446|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350447|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350448|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350449|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350461|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350462|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350463|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350464|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350465|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350466|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350467|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350468|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350469|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350470|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350471|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350472|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350473|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350474|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350475|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350476|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350477|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350478|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350479|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350480|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350481|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350482|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350483|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350484|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350485|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350486|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350487|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350488|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350489|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350490|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350491|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350492|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350493|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350494|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350495|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350496|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350497|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350498|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350499|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350500|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350501|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350502|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350503|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350504|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350505|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350506|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350507|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350508|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350509|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350510|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350511|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350512|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350513|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350514|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350515|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350516|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350517|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350518|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350519|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350520|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350521|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350522|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350523|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350524|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350525|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350526|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350527|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350528|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350529|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350530|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350531|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350532|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350533|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350534|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350535|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350536|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350537|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350538|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350539|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350540|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350541|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350543|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350544|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350545|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350546|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350547|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350548|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350549|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350550|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350551|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350552|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350553|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350554|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350555|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350556|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350557|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350558|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350559|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350560|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350561|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350562|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350563|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350564|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350565|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350566|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350567|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350568|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350569|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350570|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350571|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350572|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350573|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350574|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350575|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350576|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350577|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350578|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350579|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350580|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350581|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350582|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350583|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350584|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350585|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350586|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350587|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350588|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350589|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350590|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350591|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350592|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350593|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350594|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350595|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350596|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350597|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350598|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350599|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350600|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350601|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350602|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350603|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350604|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350605|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350606|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350607|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350608|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350609|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350610|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
350611|NCT00359788|E2|Reported Event|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
350612|NCT00359788|E1|Reported Event|Tiotropium|18 mcg once daily
350613|NCT00359801|B3|Baseline|Total|Total of all reporting groups
350614|NCT00359801|B2|Baseline|Non-Exubera®|Usual diabetes care
350615|NCT00359801|B1|Baseline|Exubera®|Exubera® plus usual diabetes care
350616|NCT00359801|P2|Participant Flow|Non-Exubera®|Usual diabetes care
350617|NCT00359801|P1|Participant Flow|Exubera®|Exubera® plus usual diabetes care
350618|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
350619|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
350620|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
350621|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
350622|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
350623|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
350647|NCT00359801|E1|Reported Event|Exubera®|Exubera® plus usual diabetes care
350648|NCT00359944|B4|Baseline|Total|Total of all reporting groups
350649|NCT00359944|B3|Baseline|Placebo|Sugar Pill twice daily
350650|NCT00359944|B2|Baseline|AC-3933, 20 mg|AC-3933, 20 mg twice daily
350651|NCT00359944|B1|Baseline|AC-3933|AC-3933, 5mg twice daily
350652|NCT00359944|P3|Participant Flow|Placebo|Sugar Pill twice daily
350653|NCT00359944|P2|Participant Flow|AC-3933, 20 mg|AC-3933, 20 mg twice daily
350654|NCT00359944|P1|Participant Flow|AC-3933, 5 mg|AC-3933, 5mg twice daily
350655|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
350656|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
350657|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
350658|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
350659|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
350660|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
350661|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
350662|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
350663|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
350664|NCT00359944|E3|Reported Event|Placebo|Sugar Pill twice daily
350665|NCT00359944|E2|Reported Event|AC-3933, 20 mg|AC-3933, 20 mg twice daily
350666|NCT00359944|E1|Reported Event|AC-3933, 5 mg|AC-3933, 5mg twice daily
350667|NCT00361972|B3|Baseline|Total|Total of all reporting groups
350668|NCT00361972|B2|Baseline|Placebo|placebo comparator to lansoprazole 30 mg twice daily for 6 weeks
350669|NCT00361972|B1|Baseline|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
350670|NCT00361972|P2|Participant Flow|Placebo|placebo comparator to lansoprazole, 30 mg, twice a day for 6 weeks
350671|NCT00361972|P1|Participant Flow|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
350672|NCT00361972|O2|Outcome|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
350673|NCT00361972|O1|Outcome|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
350674|NCT00361972|O2|Outcome|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
350675|NCT00361972|O1|Outcome|Lansoprazole|lansoprazole: 30 mg lansoprazole twice daily for 6 weeks
350676|NCT00361972|E2|Reported Event|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
350677|NCT00361972|E1|Reported Event|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
350678|NCT00362115|B8|Baseline|Total|Total of all reporting groups
350679|NCT00362115|B7|Baseline|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350680|NCT00362115|B6|Baseline|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350681|NCT00362115|B5|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350682|NCT00362115|B4|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350683|NCT00362115|B3|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350684|NCT00362115|B2|Baseline|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350685|NCT00362115|B1|Baseline|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350686|NCT00362115|P7|Participant Flow|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350687|NCT00362115|P6|Participant Flow|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350688|NCT00362115|P5|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350689|NCT00362115|P4|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350690|NCT00362115|P3|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350691|NCT00362115|P2|Participant Flow|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350692|NCT00362115|P1|Participant Flow|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350693|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350694|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350695|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350696|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350697|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350698|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350699|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350700|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350701|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350702|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350703|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350704|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350705|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350706|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350707|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350708|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350709|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350710|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350711|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350712|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350713|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350714|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350715|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350716|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350717|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350718|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350719|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350720|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350721|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350722|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350723|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350724|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350725|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350726|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350727|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350728|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350729|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350730|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350731|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350732|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350733|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350734|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350735|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350736|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350737|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350738|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350739|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350740|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350741|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350742|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350743|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350744|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350745|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350746|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350747|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350748|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350749|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350750|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350751|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350752|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350753|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350754|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350755|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350756|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350757|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350758|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350759|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350760|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350761|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350762|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350763|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350764|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350765|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350766|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350767|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350768|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350769|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350770|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350771|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350772|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350773|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350774|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350775|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350776|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350777|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350778|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350779|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350780|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350781|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350782|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350783|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350784|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350785|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350786|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350787|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350788|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350789|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350790|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350791|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
351051|NCT00362440|O1|Outcome|Leptin|"Leptin replacement therapy
Leptin+pioglitazone"
350792|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350793|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350794|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350795|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350796|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350797|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350798|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350799|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350800|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350801|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350802|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
351566|NCT00355082|B2|Baseline|Treatment Phase: LTG XR, 250 mg|LTG XR, 250 mg/day in the Treatment phase
350803|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350804|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350805|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350806|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350807|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350808|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350809|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350810|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350811|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350812|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350813|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350814|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350815|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350816|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350817|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350818|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350819|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350820|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350821|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350822|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350823|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350824|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350825|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350826|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350827|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350828|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350829|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350830|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350831|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350832|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350833|NCT00362115|E7|Reported Event|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
350834|NCT00362115|E6|Reported Event|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350835|NCT00362115|E5|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350836|NCT00362115|E4|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350837|NCT00362115|E3|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350838|NCT00362115|E2|Reported Event|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350839|NCT00362115|E1|Reported Event|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
350840|NCT00362128|B1|Baseline|Observational|The study design was a cross-sectional observational cohort design.
350841|NCT00362128|P1|Participant Flow|Observational|The study design was a cross-sectional observational cohort design.
350842|NCT00362128|O1|Outcome|Observational|The study design was a cross-sectional observational cohort design.
350843|NCT00362128|E1|Reported Event|Observational|The study design was a cross-sectional observational cohort design.
350844|NCT00362180|B10|Baseline|Total|Total of all reporting groups
350845|NCT00362180|B9|Baseline|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350943|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350846|NCT00362180|B8|Baseline|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350847|NCT00362180|B7|Baseline|Cohort F: no Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
350848|NCT00362180|B6|Baseline|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
350849|NCT00362180|B5|Baseline|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
350850|NCT00362180|B4|Baseline|Cohort D: Placebo|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
350851|NCT00362180|B3|Baseline|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350852|NCT00362180|B2|Baseline|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
350853|NCT00362180|B1|Baseline|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350854|NCT00362180|P9|Participant Flow|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350855|NCT00362180|P8|Participant Flow|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350856|NCT00362180|P7|Participant Flow|Cohort F: no Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
350857|NCT00362180|P6|Participant Flow|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
350858|NCT00362180|P5|Participant Flow|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
350859|NCT00362180|P4|Participant Flow|Cohort D: Placebo|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
350860|NCT00362180|P3|Participant Flow|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350861|NCT00362180|P2|Participant Flow|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
350862|NCT00362180|P1|Participant Flow|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350863|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350864|NCT00362180|O7|Outcome|Cohort G: Placebo Follwed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350865|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
350866|NCT00362180|O5|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
350867|NCT00362180|O4|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
350868|NCT00362180|O3|Outcome|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350869|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350870|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
350871|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350872|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350873|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
350874|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
350875|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
350876|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350877|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350878|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
351001|NCT00362375|B3|Baseline|Total|Total of all reporting groups
351329|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
350879|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350880|NCT00362180|O7|Outcome|Cohort G: Placebo Follwed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350881|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
350882|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
350883|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
350884|NCT00362180|O3|Outcome|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350885|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350886|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
350887|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350888|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350889|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
350890|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
350891|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
350892|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350893|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350894|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
350895|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350896|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350897|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
350898|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
350899|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
350900|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350901|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350902|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
350903|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350904|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
351052|NCT00362440|O2|Outcome|Pioglitazone or Metformin|"Diabetes treatment therapy
Pioglitazone+placebo"
350905|NCT00362180|O6|Outcome|Cohort F: no Study Intervention|Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
350906|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
350907|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
350908|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350909|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350910|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
350911|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350912|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
350913|NCT00362180|O6|Outcome|Cohort F: no Study Intervention|Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
350914|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
350915|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
350916|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350917|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
350918|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
350919|NCT00362180|E3|Reported Event|Not Treated|Not Treated
350920|NCT00362180|E2|Reported Event|Mipomersen|Mipomersen
350921|NCT00362180|E1|Reported Event|Placebo|Placebo
350922|NCT00362232|B3|Baseline|Total|Total of all reporting groups
350923|NCT00362232|B2|Baseline|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350924|NCT00362232|B1|Baseline|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350925|NCT00362232|P2|Participant Flow|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350926|NCT00362232|P1|Participant Flow|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350927|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350928|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350929|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350930|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350931|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350932|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350933|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350934|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350935|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350936|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350937|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350938|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350939|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350940|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350941|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350942|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350944|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350945|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350946|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350947|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350948|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350949|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350950|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350951|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350952|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350953|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350954|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350955|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350956|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350957|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350958|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350959|NCT00362232|E2|Reported Event|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
350960|NCT00362232|E1|Reported Event|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
350961|NCT00362297|B3|Baseline|Total|Total of all reporting groups
350962|NCT00362297|B2|Baseline|High-dose|
350963|NCT00362297|B1|Baseline|Standard Dose|
350964|NCT00362297|P2|Participant Flow|High-dose|
350965|NCT00362297|P1|Participant Flow|Standard Dose|
350966|NCT00362297|O2|Outcome|High Dose Acyclovir|
350967|NCT00362297|O1|Outcome|Standardy Dose Valacyclovir|
350968|NCT00362297|E2|Reported Event|High-dose|
350969|NCT00362297|E1|Reported Event|Standard Dose|
350970|NCT00362336|B4|Baseline|Total|Total of all reporting groups
351053|NCT00362440|O1|Outcome|Leptin|"Leptin replacement therapy
Leptin+pioglitazone"
351094|NCT00362466|P2|Participant Flow|Imatinib|600 mg QD
350971|NCT00362336|B3|Baseline|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350972|NCT00362336|B2|Baseline|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350973|NCT00362336|B1|Baseline|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
352343|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
350974|NCT00362336|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350975|NCT00362336|P2|Participant Flow|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350976|NCT00362336|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350977|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350978|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350979|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350980|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350981|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350982|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350983|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
351054|NCT00362440|O2|Outcome|Pioglitazone or Metformin|"Diabetes treatment therapy
Pioglitazone+placebo"
351055|NCT00362440|O1|Outcome|Leptin|"Leptin replacement therapy
Leptin+pioglitazone"
351056|NCT00362440|E2|Reported Event|Pioglitazone or Metformin|"Diabetes treatment therapy
Pioglitazone+placebo"
350984|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350985|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP-T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350986|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350987|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350988|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP-T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350989|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350990|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350991|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350992|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350993|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350994|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350995|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350996|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350997|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350998|NCT00362336|E3|Reported Event|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
350999|NCT00362336|E2|Reported Event|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
351000|NCT00362336|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
351002|NCT00362375|B2|Baseline|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
351003|NCT00362375|B1|Baseline|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
351004|NCT00362375|P2|Participant Flow|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
351005|NCT00362375|P1|Participant Flow|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
351006|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
351007|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
351008|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
351009|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
351010|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
351011|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
351012|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
351013|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
351014|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
351057|NCT00362440|E1|Reported Event|Leptin|"Leptin replacement therapy
Leptin+pioglitazone"
351058|NCT00362453|B3|Baseline|Total|Total of all reporting groups
351095|NCT00362466|P1|Participant Flow|Dasatinib|100 mg once daily (QD)
351015|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
351016|NCT00362375|E2|Reported Event|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
351017|NCT00362375|E1|Reported Event|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
351018|NCT00362401|B4|Baseline|Total|Total of all reporting groups
351019|NCT00362401|B3|Baseline|St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
351020|NCT00362401|B2|Baseline|Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
351021|NCT00362401|B1|Baseline|ATS (Open Pivot® Standard)|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
351022|NCT00362401|P3|Participant Flow|St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
351023|NCT00362401|P2|Participant Flow|Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
351024|NCT00362401|P1|Participant Flow|ATS (Open Pivot® Standard)|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
351025|NCT00362401|O3|Outcome|Group 3 - St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
351026|NCT00362401|O2|Outcome|Group 2- Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
351027|NCT00362401|O1|Outcome|Group 1 - ATS|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
351028|NCT00362414|B1|Baseline|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
351029|NCT00362414|P1|Participant Flow|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
351030|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
351031|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
351032|NCT00362414|O1|Outcome|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
351033|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
351034|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
351035|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
351036|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
351037|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
351038|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
351039|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
351040|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
351041|NCT00362414|O1|Outcome|Two Growth Factors|double growth factors
351042|NCT00362414|O1|Outcome|Dual Growth Factor|"All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.
Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation
30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation"
351043|NCT00362414|O1|Outcome|Dual Growth Factor|"All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.
Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation
30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation"
351044|NCT00362414|E1|Reported Event|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
351045|NCT00362440|B3|Baseline|Total|Total of all reporting groups
351046|NCT00362440|B2|Baseline|Pioglitazone or Metformin|"Diabetes treatment therapy
Pioglitazone+placebo"
351047|NCT00362440|B1|Baseline|Leptin|"Leptin replacement therapy
Leptin+pioglitazone"
351048|NCT00362440|P2|Participant Flow|Pioglitazone or Metformin|"Diabetes treatment therapy
Pioglitazone+placebo"
351049|NCT00362440|P1|Participant Flow|Leptin|"Leptin replacement therapy
Leptin+pioglitazone"
351050|NCT00362440|O2|Outcome|Pioglitazone or Metformin|"Diabetes treatment therapy
Pioglitazone+placebo"
351059|NCT00362453|B2|Baseline|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351060|NCT00362453|B1|Baseline|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351061|NCT00362453|P2|Participant Flow|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351062|NCT00362453|P1|Participant Flow|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351063|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351064|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351065|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351567|NCT00355082|B1|Baseline|Treatment Phase: LTG XR, 300 mg|LTG XR, 300 mg/day in the Treatment phase
351066|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351067|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351068|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351069|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351070|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351071|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351072|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351073|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351074|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351075|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351076|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351077|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351078|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351079|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351080|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351081|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351082|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351083|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351084|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351085|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351086|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351087|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351088|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351089|NCT00362453|E2|Reported Event|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
351090|NCT00362453|E1|Reported Event|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
351091|NCT00362466|B3|Baseline|Total|Total of all reporting groups
351092|NCT00362466|B2|Baseline|Imatinib|600 mg QD
351096|NCT00362466|O2|Outcome|Imatinib|600 mg QD
351097|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
351098|NCT00362466|O2|Outcome|Imatinib|600 mg QD
351099|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
351100|NCT00362466|O2|Outcome|Imatinib|600 mg QD
351101|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
351102|NCT00362466|O2|Outcome|Imatinib|600 mg QD
351103|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
351104|NCT00362466|O2|Outcome|Imatinib|600 mg QD
351105|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
351106|NCT00362466|O2|Outcome|Imatinib|600 mg QD
351107|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
351108|NCT00362466|O2|Outcome|Imatinib|600 mg QD
351109|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
351110|NCT00362466|O2|Outcome|Imatinib|600 mg QD
351111|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
351112|NCT00362466|E2|Reported Event|Imatinib|600 mg QD
351113|NCT00362466|E1|Reported Event|Dasatinib|100 mg once daily (QD)
351114|NCT00362609|B3|Baseline|Total|Total of all reporting groups
351115|NCT00362609|B2|Baseline|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
351734|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide
351116|NCT00362609|B1|Baseline|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
351117|NCT00362609|P2|Participant Flow|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
351118|NCT00362609|P1|Participant Flow|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
351119|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
351120|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
351121|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
351122|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
351123|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
351124|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
351125|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
351126|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
351127|NCT00362609|E2|Reported Event|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
351128|NCT00362609|E1|Reported Event|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
351129|NCT00362648|B5|Baseline|Total|Total of all reporting groups
351130|NCT00362648|B4|Baseline|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351131|NCT00362648|B3|Baseline|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351132|NCT00362648|B2|Baseline|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351133|NCT00362648|B1|Baseline|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351134|NCT00362648|P4|Participant Flow|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351135|NCT00362648|P3|Participant Flow|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351136|NCT00362648|P2|Participant Flow|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351137|NCT00362648|P1|Participant Flow|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351138|NCT00362648|O2|Outcome|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351139|NCT00362648|O1|Outcome|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351140|NCT00362648|O2|Outcome|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351141|NCT00362648|O1|Outcome|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351142|NCT00362648|O4|Outcome|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351143|NCT00362648|O3|Outcome|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351144|NCT00362648|O2|Outcome|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351145|NCT00362648|O1|Outcome|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
351146|NCT00362648|E6|Reported Event|Placebo - Kenya Safety Cohort|A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
351330|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351147|NCT00362648|E5|Reported Event|RotaTeq™ - Kenya Safety Cohort|A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
351148|NCT00362648|E4|Reported Event|Placebo, Placebo, RotaTeq™|"Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.
Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination."
351149|NCT00362648|E3|Reported Event|RotaTeq™, Placebo, RotaTeq™|"Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.
Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination."
351150|NCT00362648|E2|Reported Event|Placebo|"Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
SAEs were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).
Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination."
351151|NCT00362648|E1|Reported Event|RotaTeq™|"Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).
Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination."
351152|NCT00362817|B1|Baseline|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin
temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.
carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
351153|NCT00362817|P1|Participant Flow|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin
temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.
carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
351154|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin
temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.
carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
351155|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin
temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.
carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
351156|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin
temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.
carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
351157|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin
carboplatin: IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.
temozolomide: 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks."
351158|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin
temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.
carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
351159|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin
temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.
carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
351160|NCT00362817|E1|Reported Event|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin
temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.
carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
351161|NCT00362882|B3|Baseline|Total|Total of all reporting groups
351201|NCT00363077|P2|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351162|NCT00362882|B2|Baseline|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351163|NCT00362882|B1|Baseline|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351164|NCT00362882|P2|Participant Flow|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351205|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351165|NCT00362882|P1|Participant Flow|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351166|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351167|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351168|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351169|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351170|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351171|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351172|NCT00362882|E2|Reported Event|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351173|NCT00362882|E1|Reported Event|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.
docetaxel: Given IV
bortezomib: Given IV
laboratory biomarker analysis: correlative study
immunoenzyme technique: correlative study
immunohistochemistry staining method: correlative study
pharmacological study: correlative study"
351174|NCT00363038|B1|Baseline|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
351175|NCT00363038|P1|Participant Flow|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum United States Pharmacopeia (USP) as placebo.
351176|NCT00363038|O1|Outcome|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
351177|NCT00363038|E1|Reported Event|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
351178|NCT00363051|B3|Baseline|Total|Total of all reporting groups
351179|NCT00363051|B2|Baseline|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
351180|NCT00363051|B1|Baseline|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
351181|NCT00363051|P2|Participant Flow|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
351801|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351182|NCT00363051|P1|Participant Flow|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
351183|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
351325|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351184|NCT00363051|O2|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
351185|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
351186|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
351187|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
351188|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
351189|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
351190|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
351191|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
351192|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
351193|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
351194|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
351195|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
351196|NCT00363051|E2|Reported Event|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
351197|NCT00363051|E1|Reported Event|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
351198|NCT00363077|B3|Baseline|Total|Total of all reporting groups
351199|NCT00363077|B2|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351200|NCT00363077|B1|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351802|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351202|NCT00363077|P1|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351203|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351204|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351735|NCT00355394|O1|Outcome|Placebo|Placebo
351206|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351207|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351208|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351209|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351210|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351211|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351212|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351213|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351214|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351215|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351216|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351217|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351218|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351219|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351220|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351221|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351222|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351223|NCT00363077|E2|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351224|NCT00363077|E1|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
351225|NCT00363129|B3|Baseline|Total|Total of all reporting groups
351226|NCT00363129|B2|Baseline|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351227|NCT00363129|B1|Baseline|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351228|NCT00363129|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351229|NCT00363129|P1|Participant Flow|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351230|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351231|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351232|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351233|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351234|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351235|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351326|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351236|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351237|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351238|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351239|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351240|NCT00363129|E2|Reported Event|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351241|NCT00363129|E1|Reported Event|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
351242|NCT00363142|B3|Baseline|Total|Total of all reporting groups
351243|NCT00363142|B2|Baseline|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351244|NCT00363142|B1|Baseline|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351245|NCT00363142|P2|Participant Flow|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351246|NCT00363142|P1|Participant Flow|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351247|NCT00363142|O3|Outcome|FPV/RTV 700/100 mg BID|Twice daily FPV regimen boosted with a reduced dose of RTV 100 mg
351248|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700/100mg twice a day [BID] or 1400/200mg QD)
351249|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400/100mg once a day (QD)
351250|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351251|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351252|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351253|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351254|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351255|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351256|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351257|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351258|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351259|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351260|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351261|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351262|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351263|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351264|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351265|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351266|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351267|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351268|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351269|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351270|NCT00363142|E2|Reported Event|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
351271|NCT00363142|E1|Reported Event|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
351272|NCT00363168|B3|Baseline|Total|Total of all reporting groups
351273|NCT00363168|B2|Baseline|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
351274|NCT00363168|B1|Baseline|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
351275|NCT00363168|P2|Participant Flow|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
351276|NCT00363168|P1|Participant Flow|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
351277|NCT00363168|O2|Outcome|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
351278|NCT00363168|O1|Outcome|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
351279|NCT00363168|O2|Outcome|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
351280|NCT00363168|O1|Outcome|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
351281|NCT00363168|E2|Reported Event|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
351282|NCT00363168|E1|Reported Event|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
351283|NCT00363246|B1|Baseline|Group 1|Older veterans who use a wheelchair for their primary means of mobility.
351284|NCT00363246|P1|Participant Flow|Group 1|Older veterans who use a wheelchair for their primary means of mobility.
351285|NCT00363246|O1|Outcome|Wheelchair-using Veterans|Older Veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
351286|NCT00363246|O1|Outcome|Wheelchair-using Veterans|Older veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
351287|NCT00363246|E1|Reported Event|Elderly Veterans Using Wheelchairs for Mobility|Older veterans who use a wheelchair for their primary means of mobility. This was an observational study. There was no intervention and thus no adverse events were collected as part of the study. Sometimes we learned of a death from a relative when we called monthly.
351288|NCT00363298|B3|Baseline|Total|Total of all reporting groups
351327|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351328|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351289|NCT00363298|B2|Baseline|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
351290|NCT00363298|B1|Baseline|D-amphetamine|"Dextro-amphetamine: dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.
Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
351291|NCT00363298|P2|Participant Flow|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
351292|NCT00363298|P1|Participant Flow|D-amphetamine|"Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.
Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
351293|NCT00363298|O2|Outcome|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
351294|NCT00363298|O1|Outcome|D-amphetamine|"Dextro-amphetamine: dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.
Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
351295|NCT00363298|O2|Outcome|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
351296|NCT00363298|O1|Outcome|D-amphetamine|"Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.
Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
351297|NCT00363298|E2|Reported Event|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
351298|NCT00363298|E1|Reported Event|D-amphetamine|Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.
351299|NCT00363311|B3|Baseline|Total|Total of all reporting groups
351300|NCT00363311|B2|Baseline|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351301|NCT00363311|B1|Baseline|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351302|NCT00363311|P2|Participant Flow|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351303|NCT00363311|P1|Participant Flow|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 milligrams (mg) administered orally once daily for 156 weeks
351304|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351305|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351306|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351307|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351308|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351309|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351310|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351311|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351312|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351313|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351314|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351315|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351316|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351317|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351318|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351319|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351320|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351321|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351322|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351323|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351324|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351736|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide
351331|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351332|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351333|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351334|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351335|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351336|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351337|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351338|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351339|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351340|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351341|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351342|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351343|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351344|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351345|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351346|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351347|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351348|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351349|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351350|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351351|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351352|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351353|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351354|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351355|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351356|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351357|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351358|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351359|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351360|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351361|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351362|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351363|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351364|NCT00363311|E2|Reported Event|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
351365|NCT00363311|E1|Reported Event|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
351366|NCT00363415|B3|Baseline|Total|Total of all reporting groups
351367|NCT00363415|B2|Baseline|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351368|NCT00363415|B1|Baseline|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351369|NCT00363415|P2|Participant Flow|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351803|NCT00355615|O4|Outcome|Placebo|placebo
351370|NCT00363415|P1|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351371|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351372|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351373|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351374|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351375|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351516|NCT00364156|B2|Baseline|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
351376|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351377|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351378|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351379|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351380|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351381|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351382|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
351383|NCT00363415|E2|Reported Event|Etoposide + Carboplatin|"Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
(Participants who received at least one dose of study drug)"
351384|NCT00363415|E1|Reported Event|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles (Participants who received at least one dose of study drug)
351385|NCT00363467|B1|Baseline|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
351386|NCT00363467|P1|Participant Flow|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
351387|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
351388|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
351389|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
351390|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
351391|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
351392|NCT00363467|E1|Reported Event|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
351393|NCT00363545|B3|Baseline|Total|Total of all reporting groups
351394|NCT00363545|B2|Baseline|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351395|NCT00363545|B1|Baseline|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351396|NCT00363545|P2|Participant Flow|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351397|NCT00363545|P1|Participant Flow|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351398|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351399|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351400|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351401|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351402|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351403|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351804|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351404|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351405|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351406|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351407|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351408|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351409|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351410|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351411|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351412|NCT00363545|E2|Reported Event|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351413|NCT00363545|E1|Reported Event|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
351414|NCT00363675|B1|Baseline|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
351415|NCT00363675|P1|Participant Flow|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
351416|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
351417|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
351418|NCT00363675|O1|Outcome|Normal as Defined by Hand Therapist.|Children were administered hand assessments to measure function after hand burns by a trained therapist.
351419|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
351420|NCT00363675|E1|Reported Event|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
351421|NCT00363779|B1|Baseline|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
351422|NCT00363779|P1|Participant Flow|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
351423|NCT00363779|O1|Outcome|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
351424|NCT00363779|O1|Outcome|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
351425|NCT00363779|E1|Reported Event|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
351426|NCT00363805|B4|Baseline|Total|Total of all reporting groups
351427|NCT00363805|B3|Baseline|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
351428|NCT00363805|B2|Baseline|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
351429|NCT00363805|B1|Baseline|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
351430|NCT00363805|P3|Participant Flow|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
351431|NCT00363805|P2|Participant Flow|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
351432|NCT00363805|P1|Participant Flow|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
351433|NCT00363805|O3|Outcome|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
351434|NCT00363805|O2|Outcome|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
351435|NCT00363805|O1|Outcome|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
351436|NCT00363805|O3|Outcome|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
351437|NCT00363805|O2|Outcome|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
351438|NCT00363805|O1|Outcome|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
351439|NCT00363805|E3|Reported Event|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
351440|NCT00363805|E2|Reported Event|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
351441|NCT00363805|E1|Reported Event|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
351442|NCT00363883|B1|Baseline|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
351443|NCT00363883|P1|Participant Flow|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
351444|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
351445|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
351446|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
351447|NCT00363883|E1|Reported Event|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
351448|NCT00363896|B3|Baseline|Total|Total of all reporting groups
351449|NCT00363896|B2|Baseline|Placebo|Placebo by inhalation
351450|NCT00363896|B1|Baseline|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
351451|NCT00363896|P2|Participant Flow|Placebo|Placebo by inhalation
351452|NCT00363896|P1|Participant Flow|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
351453|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
351454|NCT00363896|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
351455|NCT00363896|O2|Outcome|Placebo|Placebo by inhalation
351456|NCT00363896|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
351457|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
351458|NCT00363896|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
351459|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
351460|NCT00363896|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
351461|NCT00363896|E2|Reported Event|Placebo|Placebo by inhalation
351462|NCT00363896|E1|Reported Event|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
351463|NCT00364013|B3|Baseline|Total|Total of all reporting groups
351464|NCT00364013|B2|Baseline|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351465|NCT00364013|B1|Baseline|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351466|NCT00364013|P2|Participant Flow|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351467|NCT00364013|P1|Participant Flow|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351468|NCT00364013|O2|Outcome|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351469|NCT00364013|O1|Outcome|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351470|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351471|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351472|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351473|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351474|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351475|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351476|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351477|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351805|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351478|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351479|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351480|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351481|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351482|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351483|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351484|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351485|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351486|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351487|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351488|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351489|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351490|NCT00364013|E2|Reported Event|FOLFOX Alone|Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
351491|NCT00364013|E1|Reported Event|Panitumumab Plus FOLFOX|Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
351492|NCT00364130|B3|Baseline|Total|Total of all reporting groups
351493|NCT00364130|B2|Baseline|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
351494|NCT00364130|B1|Baseline|Active|"Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
351495|NCT00364130|P2|Participant Flow|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
351496|NCT00364130|P1|Participant Flow|Active|"Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
351497|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
351498|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
351499|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
351500|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
351501|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
351502|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
351503|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
351504|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
351505|NCT00364130|O2|Outcome|Inactive Low Magnitude Mechanical Stimulus|"Inactive, or placebo low magnitude mechanical stimulus
Placebo (inactive) low magnitude mechanical stimulus: 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device"
351506|NCT00364130|O1|Outcome|Active Low Magnitude Mechanical Stimulus|"Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus: 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
351507|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
351508|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
351509|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
351806|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351510|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
351511|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
351512|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
351513|NCT00364130|E2|Reported Event|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
351514|NCT00364130|E1|Reported Event|Active|"Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
351515|NCT00364156|B3|Baseline|Total|Total of all reporting groups
351564|NCT00364286|E1|Reported Event|Dasatinib|Dasatinib 50mg Orally twice daily.
351517|NCT00364156|B1|Baseline|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
351518|NCT00364156|P2|Participant Flow|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
351519|NCT00364156|P1|Participant Flow|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
351520|NCT00364156|O2|Outcome|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
351521|NCT00364156|O1|Outcome|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
351522|NCT00364156|E2|Reported Event|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
351523|NCT00364156|E1|Reported Event|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
351524|NCT00364182|B4|Baseline|Total|Total of all reporting groups
351525|NCT00364182|B3|Baseline|BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion.
351526|NCT00364182|B2|Baseline|BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion.
351527|NCT00364182|B1|Baseline|Pre-Randomization|Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized.
351528|NCT00364182|P3|Participant Flow|BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion.
351529|NCT00364182|P2|Participant Flow|BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion.
351530|NCT00364182|P1|Participant Flow|Pre-Randomization|Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized.
351531|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
351532|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
351533|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
351534|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
351535|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
351536|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
351537|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
351538|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
351539|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
351540|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
351541|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
351542|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
351543|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
351544|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
351545|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
351546|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
351547|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
351548|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
351549|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
351550|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
351551|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
351552|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
351553|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
351554|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
351555|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
351556|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
351557|NCT00364182|E4|Reported Event|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
351558|NCT00364182|E3|Reported Event|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
351559|NCT00364182|E2|Reported Event|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
351560|NCT00364182|E1|Reported Event|BeneFIX OD1|BeneFIX in an on-demand IV bolus infusion for 16 weeks (first intervention)
351561|NCT00364286|B1|Baseline|Dasatinib|Dasatinib 50mg Orally twice daily.
351562|NCT00364286|P1|Participant Flow|Dasatinib|Dasatinib 50mg Orally twice daily.
351563|NCT00364286|O1|Outcome|Dasatinib|Dasatinib 50mg Orally twice daily.
351568|NCT00355082|P3|Participant Flow|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
351569|NCT00355082|P2|Participant Flow|LTG XR, 250 mg|LTG XR, 250 mg/day
351570|NCT00355082|P1|Participant Flow|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day. In the Continuation phase, Treatment phase participants received LTG XR, 300 mg/day.
351571|NCT00355082|O2|Outcome|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
351572|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|Treatment phase participants; LTG XR, 300 mg/day
351573|NCT00355082|O2|Outcome|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
351574|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|Treatment phase participants; LTG XR, 300 mg/day
351575|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
351576|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
351577|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
351578|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
351579|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
351580|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
351581|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
351582|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
351583|NCT00355082|O1|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
351584|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
351585|NCT00355082|E4|Reported Event|Continuation Phase: Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
351586|NCT00355082|E3|Reported Event|Continuation Phase: LTG XR, 300 mg|Treatment phase participants; LTG XR, 300 mg/day
351587|NCT00355082|E2|Reported Event|Treatment Phase: LTG XR, 250 mg|LTG XR, 250 mg/day in the Treatment phase
351588|NCT00355082|E1|Reported Event|Treatment Phase: LTG XR, 300 mg|LTG XR, 300 mg/day in the Treatment phase
351589|NCT00355121|B4|Baseline|Total|Total of all reporting groups
351590|NCT00355121|B3|Baseline|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
351591|NCT00355121|B2|Baseline|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
351592|NCT00355121|B1|Baseline|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
351593|NCT00355121|P3|Participant Flow|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
351594|NCT00355121|P2|Participant Flow|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
351595|NCT00355121|P1|Participant Flow|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
351596|NCT00355121|O3|Outcome|Group 3: DAPTACEL on Day 30 (Visit 2)|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
351597|NCT00355121|O2|Outcome|Group 2: IPOL on Day 30 (Visit 2)|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
351724|NCT00355394|P2|Participant Flow|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
351598|NCT00355121|O1|Outcome|Group 1: Menactra on Day 30 (Visit 2)|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
351599|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
351600|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
351601|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
351737|NCT00355394|O1|Outcome|Placebo|Placebo
351738|NCT00355394|E2|Reported Event|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
352344|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
351602|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
351603|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
351604|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
351605|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
351606|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
351607|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
351608|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
351609|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
351610|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
351611|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
351612|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
351613|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
351614|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
351615|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
351616|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
351617|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
351807|NCT00355615|O4|Outcome|Placebo|placebo
351808|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351618|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
351619|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
351620|NCT00355121|E3|Reported Event|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
351739|NCT00355394|E1|Reported Event|Placebo|Placebo group received standard care including IVF but not metoclopramide.
351740|NCT00355472|B1|Baseline|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
351621|NCT00355121|E2|Reported Event|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
351622|NCT00355121|E1|Reported Event|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
351623|NCT00355134|B6|Baseline|Total|Total of all reporting groups
351624|NCT00355134|B5|Baseline|Extension: Fingolimod 0.5 mg|Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.
351625|NCT00355134|B4|Baseline|Extension: Fingolimod 1.25 mg|Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351626|NCT00355134|B3|Baseline|Placebo (Core)|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351627|NCT00355134|B2|Baseline|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351628|NCT00355134|B1|Baseline|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351629|NCT00355134|P5|Participant Flow|Extension: Fingolimod 0.5 mg|Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.
351630|NCT00355134|P4|Participant Flow|Extension: Fingolimod 1.25 mg|Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351631|NCT00355134|P3|Participant Flow|Placebo (Core)|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351632|NCT00355134|P2|Participant Flow|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351633|NCT00355134|P1|Participant Flow|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351634|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351635|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351636|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351637|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351638|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351639|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351725|NCT00355394|P1|Participant Flow|Placebo|Placebo group received standard care including IVF but not metoclopramide.
351726|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
351809|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351640|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351641|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351642|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351643|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351644|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351645|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351646|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351647|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351648|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351649|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351650|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351651|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351652|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351653|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351654|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351655|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351656|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351657|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351658|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351659|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351660|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351661|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351662|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351663|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351664|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351665|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
351666|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351667|NCT00355134|E5|Reported Event|Extension: Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day in the Extension phase.
351668|NCT00355134|E4|Reported Event|Extension: Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351669|NCT00355134|E3|Reported Event|Core: Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
351670|NCT00355134|E2|Reported Event|Core: Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase.
351671|NCT00355134|E1|Reported Event|Core: Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
351672|NCT00355147|B3|Baseline|Total|Total of all reporting groups
351673|NCT00355147|B2|Baseline|Attention Control Group|Received Phone Calls from Staff to Control for Attention
351674|NCT00355147|B1|Baseline|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support
Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors
Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/Transcient Ischemic Attack"
351675|NCT00355147|P2|Participant Flow|Arm 2 Control Group|Received usual care, follow up telephone calls to control for contact, and educational materials
351676|NCT00355147|P1|Participant Flow|Arm 1 Stroke Prevention Intervention|Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support.
351677|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
351678|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support
Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors
Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/Transcient Ischemic Attack"
351679|NCT00355147|O2|Outcome|Arm 2 Control Group|Received usual care, follow up telephone calls to control for contact, and educational materials
351680|NCT00355147|O1|Outcome|Arm 1 Stroke Prevention Intervention|Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support.
351681|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
351682|NCT00355147|O1|Outcome|Arm 1 Secondary Risk Factor Management|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence
Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors
Stroke Self Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
351683|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
351727|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
351810|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351684|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support
Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors
Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
351685|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
351741|NCT00355472|P1|Participant Flow|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CC chemokine 4 receptor (CCR4) positive Adult T-Cell Leukemia-Lymphoma (ATL) or CCR4 positive Peripheral T-Cell Lymphoma (PTCL)
351686|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support
Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors
Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
351687|NCT00355147|E2|Reported Event|Attention Control Group|Received Phone Calls from Staff to Control for Attention
351688|NCT00355147|E1|Reported Event|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support
Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors
Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
351689|NCT00355199|B3|Baseline|Total|Total of all reporting groups
351690|NCT00355199|B2|Baseline|R-CHOP|"Rituximab-CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone).
Rituximab-CHOP: Rituximab-CHOP"
351691|NCT00355199|B1|Baseline|R-HDS|"R-HDS : Rituximab supplemented high-dose (Cyclophosphamide,Ara-C, Methotrexate, Etoposide, Cis-Platin) sequential chemotherapy with autografting.
Rituximab-HDS: Rituximab-HDS"
351692|NCT00355199|P2|Participant Flow|R-CHOP 14|Patients enrolled into the control arm R-CHOP (rituximab 375 mg/m2 i.v., cyclophosphamide 750 mg/m2 i.v., doxorubicin 50 mg/m2 i.v., vincristine 1.4 mg/m2 i.v. given on day 1 and 100 mg/d of prednisone p.o. on days 1–5), given every 14 days x 8 cycles. The neutropenic phase was supported by G-CSF (filgrastrim 5μg/kg s.c. daily or Pegfilgrastim s.c. given once on day +1 of each cycle). CNS prophylaxis with intrathecal chemotherapy (MTX, ARAC, steroids) was given to high risk patients who, at diagnosis, had infiltration of the bone marrow, testes, Waldeyer ring, cranial air sinuses (including nasal), salivary glands and epidural space. In R-CHOP, 33 patients (27%) received intrathecal prophylaxis. Patients with initial bulky or residual lesions received IFRT within 2-3 months after chemotherapy program.
351693|NCT00355199|P1|Participant Flow|R-HDS|R-HDS: 3 APO: first Doxorubicin at 50 mg/m2 iv, then at 75 mg/m2 iv days 14, 28; Vincristine 1.4 mg/m2 iv days 1,14,28; Prednisone p.o 40 mg/m2 days1-28). Subsequently:high-dose (hd) Cyclophosphamide 7 g/m2 iv, day 1+ Rituximab 375 mg/m2 iv days +3;+11, harvest of peripheral blood progenitor cells (PBPC); hd-Cytarabine 2 g/m2 iv bid for 6 days. Day 7:infusion 1.5-2x10^6 autologous CD34+ cells/kg, Rituximab 375 mg/m2 iv day+8;+16; hd-Etoposide 2.4 g/m2 iv day +1, Cisplatin 100 mg/m2 iv day+2; PBPC (2x10^6 CD34+ cells/Kg) reinfused following etoposide/cisplatin. ASCT conditioned with mitoxantrone 60 mg/m2 iv day -5 and melphalan 180 mg/m2 iv day –2 or BEAM (BCNU 300 mg/m2 iv day -6, Etoposide 200 mg/m2 iv days -5 to –2, Ara-C 200 mg/m2 iv every 12 h x8 doses, days from -5 to -2, Melphalan 140 mg/m2 iv day-1),supported by PBPC autograft day 0. Two Rituximab days +14;+24 after ASCT. Patients with initial bulky or residual lesions received IFRT within 2-3 months after chemotherapy program.
351694|NCT00355199|O2|Outcome|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
351695|NCT00355199|O1|Outcome|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
351696|NCT00355199|O2|Outcome|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
351697|NCT00355199|O1|Outcome|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
351698|NCT00355199|O2|Outcome|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
351699|NCT00355199|O1|Outcome|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
351700|NCT00355199|O2|Outcome|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
351701|NCT00355199|O1|Outcome|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
351702|NCT00355199|O2|Outcome|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
351703|NCT00355199|O1|Outcome|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
351704|NCT00355199|E2|Reported Event|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
351705|NCT00355199|E1|Reported Event|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
351706|NCT00355368|B3|Baseline|Total|Total of all reporting groups
351707|NCT00355368|B2|Baseline|Rocuronium|0.6mg/kg
351708|NCT00355368|B1|Baseline|Succinylcholine|1mg/kg
351709|NCT00355368|P2|Participant Flow|Rocuronium|0.6mg/kg
351710|NCT00355368|P1|Participant Flow|Succinylcholine|1mg/kg
351711|NCT00355368|O2|Outcome|Rocuronium|
351712|NCT00355368|O1|Outcome|Succinylcholine|
351713|NCT00355368|O2|Outcome|Rocuronium|
351714|NCT00355368|O1|Outcome|Succinylcholine|
351715|NCT00355368|O2|Outcome|Rocuronium|
351716|NCT00355368|O1|Outcome|Succinylcholine|
351717|NCT00355368|O2|Outcome|Rocuronium|
351718|NCT00355368|O1|Outcome|Succinylcholine|
351719|NCT00355368|E2|Reported Event|Rocuronium|0.6mg/kg
351720|NCT00355368|E1|Reported Event|Succinylcholine|1mg/kg
351721|NCT00355394|B3|Baseline|Total|Total of all reporting groups
351722|NCT00355394|B2|Baseline|Metoclopramide|Metoclopramide group received standard care including IVF AND metoclopramide.
351723|NCT00355394|B1|Baseline|Placebo|Placebo group received standard care including IVF but not metoclopramide.
351728|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
351729|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
351730|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
351731|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
351732|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
351733|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
351742|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL.
351743|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
351744|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
351745|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
351746|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
351747|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
351748|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
351749|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
351750|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
351751|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
351752|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
351753|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
351754|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
351755|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
351756|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
351757|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
351758|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
351759|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
351760|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
351761|NCT00355472|E4|Reported Event|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
351762|NCT00355472|E3|Reported Event|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
351763|NCT00355472|E2|Reported Event|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
351764|NCT00355472|E1|Reported Event|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
351765|NCT00355615|B5|Baseline|Total|Total of all reporting groups
351766|NCT00355615|B4|Baseline|Placebo|placebo
351767|NCT00355615|B3|Baseline|Rosuva 20|rosuvastatin 20 mg
351768|NCT00355615|B2|Baseline|Rosuva 10|rosuvastatin 10 mg
351769|NCT00355615|B1|Baseline|Rosuva 5|rosuvastatin 5 mg
351770|NCT00355615|P5|Participant Flow|Rosuva ol|rosuvastatin open label
351771|NCT00355615|P4|Participant Flow|Placebo|placebo
351772|NCT00355615|P3|Participant Flow|Rosuva 20|rosuvastatin 20 mg
351773|NCT00355615|P2|Participant Flow|Rosuva 10|rosuvastatin 10 mg
351774|NCT00355615|P1|Participant Flow|Rosuva 5|rosuvastatin 5 mg
351775|NCT00355615|O4|Outcome|Placebo|placebo
351776|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351777|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351778|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351779|NCT00355615|O4|Outcome|Placebo|placebo
351780|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351781|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351782|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351783|NCT00355615|O4|Outcome|Placebo|placebo
351784|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351785|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351786|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351787|NCT00355615|O4|Outcome|Placebo|placebo
351788|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351789|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351790|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351791|NCT00355615|O4|Outcome|Placebo|placebo
351792|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351793|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351794|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351795|NCT00355615|O4|Outcome|Placebo|placebo
351796|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351797|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351798|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351799|NCT00355615|O4|Outcome|Placebo|placebo
351800|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351811|NCT00355615|O4|Outcome|Placebo|placebo
351812|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351813|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351814|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351815|NCT00355615|O4|Outcome|Placebo|placebo
351816|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351817|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351818|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351819|NCT00355615|O4|Outcome|Placebo|placebo
351820|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351821|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351822|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351823|NCT00355615|O4|Outcome|Placebo|placebo
351824|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
351825|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
351826|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
351827|NCT00355615|E5|Reported Event|Rosuva ol|rosuvastatin open label
351828|NCT00355615|E4|Reported Event|Placebo|placebo
351829|NCT00355615|E3|Reported Event|Rosuva 20|rosuvastatin 20 mg
351830|NCT00355615|E2|Reported Event|Rosuva 10|rosuvastatin 10 mg
351831|NCT00355615|E1|Reported Event|Rosuva 5|rosuvastatin 5 mg
351832|NCT00355706|B3|Baseline|Total|Total of all reporting groups
351833|NCT00355706|B2|Baseline|Group II - With Bupivacaine and Steroid|Group II - Thoracic medial branch blocks with bupivacaine and steroid
351834|NCT00355706|B1|Baseline|Group I - With Local Anesthetics|Group I - Thoracic medial branch blocks with local anesthetics
351835|NCT00355706|P2|Participant Flow|Group II - With Steroids|Group II - Thoracic medial branch blocks with bupivacaine and steroid
351836|NCT00355706|P1|Participant Flow|Group I - Without Steroids|Group I - Thoracic medial branch blocks with local anesthetics
351837|NCT00355706|O2|Outcome|Group II - With Steroids|Thoracic medial branch blocks with bupivacaine and steroid
351838|NCT00355706|O1|Outcome|Group I - Without Steroids|Thoracic medial branch blocks with local anesthetics
351839|NCT00355706|O2|Outcome|Group II - With Steroids|Thoracic medial branch blocks with bupivacaine and steroid
351840|NCT00355706|O1|Outcome|Group I - Without Steroids|Thoracic medial branch blocks with local anesthetics
351841|NCT00355706|O2|Outcome|Group II With Steroid|Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Steroids (0.15 mg of non-particulate betamethasone)
351842|NCT00355706|O1|Outcome|Group I Without Steroids|Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine)
351843|NCT00355706|E2|Reported Event|Group II - With Bupivacaine and Steroid|Group II - Thoracic medial branch blocks with bupivacaine and steroid
351844|NCT00355706|E1|Reported Event|Group I - With Local Anesthetics|Group I - Thoracic medial branch blocks with local anesthetics
351845|NCT00355784|B4|Baseline|Total|Total of all reporting groups
351846|NCT00355784|B3|Baseline|High Growth Hormone Treatment|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone.
351847|NCT00355784|B2|Baseline|Growth Hormone Treatment|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351848|NCT00355784|B1|Baseline|Control|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
351849|NCT00355784|P3|Participant Flow|High Growth Hormone Treatment|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
351850|NCT00355784|P2|Participant Flow|Growth Hormone Treatment|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351851|NCT00355784|P1|Participant Flow|Control|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
351852|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
351853|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351854|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
351855|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
351875|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
351856|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351857|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
351858|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
351859|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351860|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
352345|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
351861|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
351862|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351863|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
351864|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
351865|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351866|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
351867|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
351868|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351869|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
351870|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
351871|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351872|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
351873|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
351874|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351911|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
351912|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
351876|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
351877|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351878|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
351879|NCT00355784|E3|Reported Event|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
352346|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
351880|NCT00355784|E2|Reported Event|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
351881|NCT00355784|E1|Reported Event|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
351882|NCT00355797|B4|Baseline|Total|Total of all reporting groups
351883|NCT00355797|B3|Baseline|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
351884|NCT00355797|B2|Baseline|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
351885|NCT00355797|B1|Baseline|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
351886|NCT00355797|P3|Participant Flow|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
351887|NCT00355797|P2|Participant Flow|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
351888|NCT00355797|P1|Participant Flow|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
351889|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
351890|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
351891|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
351892|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
351893|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
351894|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
351895|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
351896|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
351897|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
351898|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
351899|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
351900|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
351901|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
351902|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
351903|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
351904|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
351905|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
351906|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
351907|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
351908|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
351909|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
351910|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
351913|NCT00355797|E3|Reported Event|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
351914|NCT00355797|E2|Reported Event|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
351915|NCT00355797|E1|Reported Event|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
351916|NCT00355914|B3|Baseline|Total|Total of all reporting groups
351917|NCT00355914|B2|Baseline|Group II With Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic with steroids
351918|NCT00355914|B1|Baseline|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
351919|NCT00355914|P2|Participant Flow|Group II With Steroids|Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and Steroids (0.15 mg of non-particulate betamethasone)
351920|NCT00355914|P1|Participant Flow|Group 1 Without Steroids|Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
351921|NCT00355914|O2|Outcome|Group II With Steroids|Facet Joint Nerve Blocks Local anesthetic with steroids
351922|NCT00355914|O1|Outcome|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
351923|NCT00355914|O2|Outcome|Group II|Local anesthetic with steroids
351924|NCT00355914|O1|Outcome|Group I|Local anesthetic without steroids
351925|NCT00355914|E2|Reported Event|Group II With Steroids|Facet Joint Nerve Blocks Local anesthetic with steroids
351926|NCT00355914|E1|Reported Event|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
351927|NCT00356031|B1|Baseline|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
351928|NCT00356031|P1|Participant Flow|Experimental: Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
351929|NCT00356031|O1|Outcome|Experimental: Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
351930|NCT00356031|O1|Outcome|Experimental: Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
351931|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
351947|NCT00356122|B1|Baseline|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of
70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,
100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,
15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
351973|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351932|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy."
351950|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of
70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,
100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,
15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
351951|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of
70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,
100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,
15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
351933|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
351934|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
351935|NCT00356031|E1|Reported Event|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
351936|NCT00356057|B4|Baseline|Total|Total of all reporting groups
351937|NCT00356057|B3|Baseline|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
351938|NCT00356057|B2|Baseline|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
351939|NCT00356057|B1|Baseline|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
351940|NCT00356057|P3|Participant Flow|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
351941|NCT00356057|P2|Participant Flow|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
351942|NCT00356057|P1|Participant Flow|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
351943|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
351944|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
351945|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
351946|NCT00356057|E1|Reported Event|All Groups|
352071|NCT00356408|O2|Outcome|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
351948|NCT00356122|P1|Participant Flow|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of
70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,
100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,
15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
351949|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of
70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,
100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,
15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
352170|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
351952|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of
70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,
100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,
15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
351953|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of
70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,
100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,
15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
351954|NCT00356122|E1|Reported Event|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of
70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,
100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,
15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
351955|NCT00356135|B4|Baseline|Total|Total of all reporting groups
351956|NCT00356135|B3|Baseline|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351957|NCT00356135|B2|Baseline|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
351958|NCT00356135|B1|Baseline|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351959|NCT00356135|P3|Participant Flow|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351960|NCT00356135|P2|Participant Flow|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
351961|NCT00356135|P1|Participant Flow|Prasgurel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351962|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351963|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
351964|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351965|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351966|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
351967|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351968|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351969|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
351970|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351971|NCT00356135|O2|Outcome|No Clopidogrel Use|Patients with no clopidogrel use at the time of qualifying ACS event.
351972|NCT00356135|O1|Outcome|Clopidogrel Use|Patients with clopidogrel use at the time of qualifying ACS event.
353296|NCT00360269|B1|Baseline|Atomoxetine|Flexible dose up to 100mg/day
351974|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
351975|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351976|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351977|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
351978|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
352076|NCT00356408|E2|Reported Event|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
351979|NCT00356135|E3|Reported Event|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351980|NCT00356135|E2|Reported Event|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
351981|NCT00356135|E1|Reported Event|Prasgurel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
351982|NCT00356148|B3|Baseline|Total|Total of all reporting groups
351983|NCT00356148|B2|Baseline|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
351984|NCT00356148|B1|Baseline|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
351985|NCT00356148|P2|Participant Flow|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
351986|NCT00356148|P1|Participant Flow|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
351987|NCT00356148|O2|Outcome|No Prophylaxis Group|Patients who are BMI over 25 and not receiving antibiotic prophylaxis
351988|NCT00356148|O1|Outcome|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
351989|NCT00356148|O2|Outcome|No Prophylaxis Group|Patients who are BMI over 25 and not receive antibiotic prophylaxis
351990|NCT00356148|O1|Outcome|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
351991|NCT00356148|E2|Reported Event|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
351992|NCT00356148|E1|Reported Event|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
351993|NCT00356200|B3|Baseline|Total|Total of all reporting groups
351994|NCT00356200|B2|Baseline|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
351995|NCT00356200|B1|Baseline|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
351996|NCT00356200|P2|Participant Flow|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
351997|NCT00356200|P1|Participant Flow|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
351998|NCT00356200|O4|Outcome|Cohort 2, Placebo Treated Lesion|Cohort 2 lesion treated with placebo
351999|NCT00356200|O3|Outcome|Cohort 2, 100 ug/ml Fluphenazine Treated Lesion|Cohort 2 100 ug/ml Fluphenazine decanoate treated lesion
352000|NCT00356200|O2|Outcome|Cohort 1, Placebo Treated Lesion|Cohort 1 lesion treated with placebo
352001|NCT00356200|O1|Outcome|Cohort 1, 10 ug/ml Fluphenazine Treated Lesion|Cohort 1 10 ug/ml Fluphenazine decanoate treated lesion
352002|NCT00356200|O4|Outcome|Cohort 2, Placebo Treated Lesion|lesion treated with placebo (Cohort 2)
352003|NCT00356200|O3|Outcome|Cohort 2, 100 ug/ml Fluphenazine Treated Lesion|lesion receiving 100 ug/ml Fluphenazine decanoate (Cohort 2)
352004|NCT00356200|O2|Outcome|Cohort 1, Placebo Treated Lesion|lesion treated with placebo (Cohort 1)
352005|NCT00356200|O1|Outcome|Cohort 1, 10 ug/ml Fluphenazine Treated Lesion|lesion receiving 10 ug/ml Fluphenazine decanoate (Cohort 1)
352006|NCT00356200|E2|Reported Event|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
352007|NCT00356200|E1|Reported Event|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
352008|NCT00356278|B4|Baseline|Total|Total of all reporting groups
352009|NCT00356278|B3|Baseline|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352010|NCT00356278|B2|Baseline|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352072|NCT00356408|O1|Outcome|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
352011|NCT00356278|B1|Baseline|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352012|NCT00356278|P3|Participant Flow|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352013|NCT00356278|P2|Participant Flow|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352014|NCT00356278|P1|Participant Flow|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352015|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352016|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352017|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352018|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352019|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352020|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352021|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352022|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352023|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352024|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352025|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352026|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352070|NCT00356408|O3|Outcome|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
352117|NCT00356434|B3|Baseline|Total|Total of all reporting groups
352027|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352028|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352029|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352030|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352031|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352032|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352033|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352034|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352035|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352036|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352037|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352038|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352039|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352040|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352041|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352042|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352043|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352044|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352045|NCT00356278|E3|Reported Event|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
Placebo: Placebo will be administered in the same manner as the active drugs."
352077|NCT00356408|E1|Reported Event|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
352078|NCT00356421|B3|Baseline|Total|Total of all reporting groups
352171|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352046|NCT00356278|E2|Reported Event|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352047|NCT00356278|E1|Reported Event|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
352048|NCT00356304|B3|Baseline|Total|Total of all reporting groups
352049|NCT00356304|B2|Baseline|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
352050|NCT00356304|B1|Baseline|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
352051|NCT00356304|P2|Participant Flow|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
352052|NCT00356304|P1|Participant Flow|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
352053|NCT00356304|O2|Outcome|Treatment as Usual|
352054|NCT00356304|O1|Outcome|Motivational Enhancement Therapy for Antidepressants|
352055|NCT00356304|O2|Outcome|Treatment as Usual|
352056|NCT00356304|O1|Outcome|Motivational Enhancement Therapy for Antidepressants|
352057|NCT00356304|E2|Reported Event|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
352058|NCT00356304|E1|Reported Event|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
352059|NCT00356408|B5|Baseline|Total|Total of all reporting groups
352060|NCT00356408|B4|Baseline|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
352061|NCT00356408|B3|Baseline|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
352062|NCT00356408|B2|Baseline|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
352063|NCT00356408|B1|Baseline|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
352064|NCT00356408|P1|Participant Flow|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn’s disease indication in the patient’s country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
352065|NCT00356408|O4|Outcome|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
352066|NCT00356408|O3|Outcome|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
352067|NCT00356408|O2|Outcome|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
352068|NCT00356408|O1|Outcome|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
352069|NCT00356408|O4|Outcome|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
352389|NCT00364533|E3|Reported Event|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352073|NCT00356408|E5|Reported Event|CDP870 400 mg (Overall)|Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn’s disease indication in the patient’s country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
352074|NCT00356408|E4|Reported Event|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
352075|NCT00356408|E3|Reported Event|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
352079|NCT00356421|B2|Baseline|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352080|NCT00356421|B1|Baseline|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352081|NCT00356421|P2|Participant Flow|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352082|NCT00356421|P1|Participant Flow|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352083|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352084|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352085|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352086|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352087|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352088|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352089|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352090|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352091|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352092|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352093|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352094|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352095|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352096|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352097|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352098|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352099|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352100|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352101|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352102|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352103|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352104|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352105|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352106|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352107|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352108|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352109|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352110|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352111|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352112|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352113|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352114|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352115|NCT00356421|E2|Reported Event|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
352116|NCT00356421|E1|Reported Event|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
352118|NCT00356434|B2|Baseline|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT
Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352119|NCT00356434|B1|Baseline|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT
Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352120|NCT00356434|P2|Participant Flow|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT
Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352142|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
352121|NCT00356434|P1|Participant Flow|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT)
Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352122|NCT00356434|O2|Outcome|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT
Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352123|NCT00356434|O1|Outcome|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT)
Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352124|NCT00356434|O2|Outcome|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT
Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352125|NCT00356434|O1|Outcome|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT)
Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352126|NCT00356434|O2|Outcome|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT
Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352127|NCT00356434|O1|Outcome|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT
Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352128|NCT00356434|E2|Reported Event|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT
Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352129|NCT00356434|E1|Reported Event|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT
Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
352130|NCT00356525|B5|Baseline|Total|Total of all reporting groups
352131|NCT00356525|B4|Baseline|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352132|NCT00356525|B3|Baseline|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
352133|NCT00356525|B2|Baseline|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352134|NCT00356525|B1|Baseline|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
352135|NCT00356525|P4|Participant Flow|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352136|NCT00356525|P3|Participant Flow|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
352137|NCT00356525|P2|Participant Flow|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352138|NCT00356525|P1|Participant Flow|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
352139|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352140|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
352141|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352169|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352347|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
352143|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352144|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
352145|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352146|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
352147|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352148|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
352149|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352150|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
352151|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352152|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
352153|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352154|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
352155|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352156|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
352157|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352158|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
352159|NCT00356525|E4|Reported Event|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352160|NCT00356525|E3|Reported Event|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
352282|NCT00357032|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies"
352161|NCT00356525|E2|Reported Event|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
352162|NCT00356525|E1|Reported Event|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
352163|NCT00356590|B1|Baseline|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352164|NCT00356590|P1|Participant Flow|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352165|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352166|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352167|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352168|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352172|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352173|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352174|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352175|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352176|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352177|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352178|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352179|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352180|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352181|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352182|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352183|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352184|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352185|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352186|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352187|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352188|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352189|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352190|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352191|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352192|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352193|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
352194|NCT00356590|E1|Reported Event|Enbrel|
352195|NCT00356811|B1|Baseline|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352196|NCT00356811|P1|Participant Flow|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel, administered as a 1-hour intravenous (IV) infusion at a dose of 80 mg/meters squared (m^2) on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352197|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352198|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352199|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352200|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352201|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352202|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352324|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352203|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352204|NCT00356811|O1|Outcome|Overall Study Arm|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352205|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352206|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352335|NCT00364351|P1|Participant Flow|Vandetanib|Vandetanib 300 mg tablet taken once daily plus a placebo for erlotinib
352336|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
352207|NCT00356811|E1|Reported Event|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
352208|NCT00356863|B3|Baseline|Total|Total of all reporting groups
352209|NCT00356863|B2|Baseline|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352210|NCT00356863|B1|Baseline|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352211|NCT00356863|P2|Participant Flow|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352212|NCT00356863|P1|Participant Flow|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352213|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352214|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352215|NCT00356863|O2|Outcome|No Education (Control) About Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352216|NCT00356863|O1|Outcome|Educational (Intervention) on Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352217|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352218|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352219|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352220|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352221|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352222|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352280|NCT00357032|P1|Participant Flow|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies"
352223|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352224|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352225|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352242|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
352226|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352227|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352228|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352229|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352230|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352231|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352232|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352233|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about CR and were giving the usual care.
352234|NCT00356863|O1|Outcome|Education (Intervention) on Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352235|NCT00356863|E2|Reported Event|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
352236|NCT00356863|E1|Reported Event|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
352237|NCT00356889|B1|Baseline|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
352238|NCT00356889|P1|Participant Flow|Bevacizumab and Erlotinib Hydrochloride|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels."
352239|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
352281|NCT00357032|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies"
352325|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352240|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels."
352241|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
352337|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
352243|NCT00356889|E1|Reported Event|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
352244|NCT00356915|B4|Baseline|Total|Total of all reporting groups
352245|NCT00356915|B3|Baseline|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
352246|NCT00356915|B2|Baseline|Itraconazole Capsules|Itraconazole 100 mg capsules
352247|NCT00356915|B1|Baseline|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
352248|NCT00356915|P3|Participant Flow|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
352249|NCT00356915|P2|Participant Flow|Itraconazole Capsules|Itraconazole 100 mg capsules
352250|NCT00356915|P1|Participant Flow|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
352251|NCT00356915|O2|Outcome|Placebo Tablets|
352252|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
352253|NCT00356915|O2|Outcome|Itraconazole Capsules|Itraconazole 100mg capsules
352254|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
352255|NCT00356915|O3|Outcome|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
352256|NCT00356915|O2|Outcome|Itraconazole Capsules|Itraconazole 100 mg capsules
352257|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
352258|NCT00356915|O2|Outcome|Placebo Tablets|
352259|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
352260|NCT00356915|E6|Reported Event|Placebo Tablets - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
352261|NCT00356915|E5|Reported Event|Itraconazole Capsules - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
352262|NCT00356915|E4|Reported Event|Itraconazole Tablets - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
352263|NCT00356915|E3|Reported Event|Placebo Tablets|Adverse events that occurred during the Treatment Period are reported here.
352264|NCT00356915|E2|Reported Event|Itraconazole Capsules|Itraconazole 100mg capsules Adverse events that occurred during the Treatment Period are reported here.
352265|NCT00356915|E1|Reported Event|Itraconazole Tablets - Treatment Period|Itraconazole 200mg tablets Adverse events that occurred during the Treatment Period are reported here.
352266|NCT00357006|B4|Baseline|Total|Total of all reporting groups
352267|NCT00357006|B3|Baseline|Placebo|
352268|NCT00357006|B2|Baseline|Adjunctive 100 mcg Transdermal Estradiol|
352269|NCT00357006|B1|Baseline|Adjunctive 200 mcg Transdermal Estradiol|
352270|NCT00357006|P3|Participant Flow|Placebo|Participants received daily transdermal placebo for 56 days.
352271|NCT00357006|P2|Participant Flow|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100mcg transdermal estradiol for 56 days.
352272|NCT00357006|P1|Participant Flow|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200mcg transdermal estradiol for 56 days.
352273|NCT00357006|O3|Outcome|Placebo|Participants received daily transdermal placebo for 56 days.
352274|NCT00357006|O2|Outcome|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100 mcg transdermal estradiol for 56 days.
352275|NCT00357006|O1|Outcome|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200 mcg transdermal estradiol for 56 days.
352276|NCT00357006|E3|Reported Event|Placebo|Participants received daily transdermal placebo for 8 weeks (56 days).
352277|NCT00357006|E2|Reported Event|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100mcg transdermal estradiol for 8 weeks (56 days).
352278|NCT00357006|E1|Reported Event|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200mcg transdermal estradiol for 8 weeks (56 days).
352279|NCT00357032|B1|Baseline|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies"
352388|NCT00364533|E4|Reported Event|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
352283|NCT00357032|E1|Reported Event|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies"
352284|NCT00357097|B3|Baseline|Total|Total of all reporting groups
352285|NCT00357097|B2|Baseline|Placebo|Subjects who took no investigational product.
352286|NCT00357097|B1|Baseline|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352287|NCT00357097|P2|Participant Flow|Placebo|Subjects who took no investigational product.
352288|NCT00357097|P1|Participant Flow|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352289|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352334|NCT00364351|P2|Participant Flow|Erlotinib|Erlotinib 150 mg tablet taken once daily plus a placebo for vandetanib
352290|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352291|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352292|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352293|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352294|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352295|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352296|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352297|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352298|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352299|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352300|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352301|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352302|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352303|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352304|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352305|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352306|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352307|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352308|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352309|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352310|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352311|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352312|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352313|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352314|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352315|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352316|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352317|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352318|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352319|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352320|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352321|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352322|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352323|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352326|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352327|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
352328|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352329|NCT00357097|E2|Reported Event|Placebo|Subjects who took no investigational product.
352330|NCT00357097|E1|Reported Event|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
352331|NCT00364351|B3|Baseline|Total|Total of all reporting groups
352332|NCT00364351|B2|Baseline|Erlotinib|Erlotinib
352333|NCT00364351|B1|Baseline|Vandetanib|Vandetanib 300 mg
352348|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
352349|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
352350|NCT00364351|E2|Reported Event|Erlotinib|Erlotinib
352351|NCT00364351|E1|Reported Event|Vandetanib|Vandetanib 300 mg
352352|NCT00364377|B3|Baseline|Total|Total of all reporting groups
352353|NCT00364377|B2|Baseline|Placebo|People with impaired fasting glucose treated with placebo once daily.
352354|NCT00364377|B1|Baseline|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
352355|NCT00364377|P2|Participant Flow|Placebo|People with impaired fasting glucose treated with placebo once daily.
352356|NCT00364377|P1|Participant Flow|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
352357|NCT00364377|O2|Outcome|Placebo|People with impaired fasting glucose treated with placebo once daily.
352358|NCT00364377|O1|Outcome|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
352359|NCT00364377|E2|Reported Event|Placebo|People with impaired fasting glucose treated with placebo once daily.
352360|NCT00364377|E1|Reported Event|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
352361|NCT00364533|B6|Baseline|Total|Total of all reporting groups
352362|NCT00364533|B5|Baseline|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
352363|NCT00364533|B4|Baseline|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
352364|NCT00364533|B3|Baseline|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352365|NCT00364533|B2|Baseline|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352366|NCT00364533|B1|Baseline|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352367|NCT00364533|P5|Participant Flow|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
352368|NCT00364533|P4|Participant Flow|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
352369|NCT00364533|P3|Participant Flow|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352370|NCT00364533|P2|Participant Flow|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352371|NCT00364533|P1|Participant Flow|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352372|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
352373|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
352374|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352375|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352376|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352377|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
352378|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
352379|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352380|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352381|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352382|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
352383|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
352384|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352385|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352386|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352387|NCT00364533|E5|Reported Event|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
355515|NCT00364949|B2|Baseline|PCOS|Polycystic Ovary Syndrome
352390|NCT00364533|E2|Reported Event|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352391|NCT00364533|E1|Reported Event|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
352392|NCT00364611|B3|Baseline|Total|Total of all reporting groups
352393|NCT00364611|B2|Baseline|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352394|NCT00364611|B1|Baseline|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352395|NCT00364611|P2|Participant Flow|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352396|NCT00364611|P1|Participant Flow|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352397|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352398|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352460|NCT00365859|B3|Baseline|Rollover Aripiprazole|As previously described in Participant Flow
352399|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352400|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352401|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352402|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352403|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352404|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352405|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352406|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352407|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352408|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352409|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352410|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352411|NCT00364611|E2|Reported Event|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352412|NCT00364611|E1|Reported Event|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
352413|NCT00365716|B6|Baseline|Total|Total of all reporting groups
352414|NCT00365716|B5|Baseline|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352444|NCT00365768|O2|Outcome|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
Placebo: Administered orally twice daily for 21 days"
352415|NCT00365716|B4|Baseline|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352416|NCT00365716|B3|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352417|NCT00365716|B2|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352418|NCT00365716|B1|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352461|NCT00365859|B2|Baseline|Rollover Placebo|As previously described in Participant Flow
352419|NCT00365716|P7|Participant Flow|Extension 2|This group includes 17 subjects from the United States, who received placebo during the base study and received 3 doses of qHPV vaccine during the Extension, or received less than 3 doses of the qHPV Vaccine during the base study and completed the dose regimen during the Extension.
352420|NCT00365716|P6|Participant Flow|Extension 1|This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.
352421|NCT00365716|P5|Participant Flow|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352422|NCT00365716|P4|Participant Flow|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352423|NCT00365716|P3|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352424|NCT00365716|P2|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352425|NCT00365716|P1|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352426|NCT00365716|O2|Outcome|Placebo (mcg) (Aluminum Adjuvant) 225 or 450 Combined|For the purposes of this outcome measure, the placebo groups (225 mcg and 450 mcg) were combined.
352427|NCT00365716|O1|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352428|NCT00365716|O5|Outcome|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352445|NCT00365768|O1|Outcome|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
Glutamine: Administered orally twice daily for 21 days"
352496|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
355516|NCT00364949|B1|Baseline|Control|Control
352429|NCT00365716|O4|Outcome|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352430|NCT00365716|O3|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352431|NCT00365716|O2|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352432|NCT00365716|O1|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352433|NCT00365716|E6|Reported Event|Extensions|"This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.
Serious Adverse Events (SAEs) were collected during Extension 1 and Extension 2. Note that the N includes only the 241 subjects vaccinated during the Extension Periods; of the 258 subjects that entered either Extension, 17 subjects discontinued before being vaccinated and therefore are not included in this table."
352434|NCT00365716|E5|Reported Event|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352435|NCT00365716|E4|Reported Event|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352436|NCT00365716|E3|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
352437|NCT00365716|E2|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
There were 2 patients from the 40/40/40/40 group that were randomized, but were never vaccinated. As such, these 2 patients are not included in this table."
352438|NCT00365716|E1|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
There was one subject randomized to the quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine 20/40/40/20 mcg group who received the 225 mcg aluminum adjuvant placebo at the third vaccination visit. This subject was not included in the counts reported in the Adverse Event tables. No SAEs were reported for this subject.
There was 1 patient that was randomized, but never vaccinated. As such, that patient is not included in this table."
352439|NCT00365768|B3|Baseline|Total|Total of all reporting groups
352440|NCT00365768|B2|Baseline|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
Placebo: Administered orally twice daily for 21 days"
352441|NCT00365768|B1|Baseline|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
Glutamine: Administered orally twice daily for 21 days"
352442|NCT00365768|P2|Participant Flow|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
Placebo: Administered orally twice daily for 21 days"
352443|NCT00365768|P1|Participant Flow|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
Glutamine: Administered orally twice daily for 21 days"
352495|NCT00365859|O4|Outcome|Total|
352446|NCT00365768|O2|Outcome|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
Placebo: Administered orally twice daily for 21 days"
352447|NCT00365768|O1|Outcome|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
Glutamine: Administered orally twice daily for 21 days"
352448|NCT00365768|E2|Reported Event|Arm II|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
Placebo: Administered orally twice daily for 21 days"
352449|NCT00365768|E1|Reported Event|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
Glutamine: Administered orally twice daily for 21 days"
352450|NCT00365846|B1|Baseline|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
352451|NCT00365846|P1|Participant Flow|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
352452|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
352453|NCT00365846|O1|Outcome|Group 1Campath 1H Induction w/ Sirolimus Immunosuppression|Campath 1H induction w/ Sirolimus immunosuppression
352454|NCT00365846|O1|Outcome|Campath 1H Induction w/ Sirolimus Immunosuppression|Campath 1H induction on Day -1 and 0 of renal transplant followed w/ Sirolimus maintenance immunosuppression
352455|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
352456|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
352457|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
352458|NCT00365846|E1|Reported Event|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
352459|NCT00365859|B4|Baseline|Total|Total of all reporting groups
353524|NCT00360555|B5|Baseline|Total|Total of all reporting groups
352462|NCT00365859|B1|Baseline|De Novo|As previously described in Participant Flow
352463|NCT00365859|P4|Participant Flow|Total|
352464|NCT00365859|P3|Participant Flow|Rollover Aripiprazole|Participants who completed participation in protocol CN138-178 [NCT00332241] or CN138-179 [NCT00337571] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
352465|NCT00365859|P2|Participant Flow|Rollover Placebo|Participants who completed participation in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
352466|NCT00365859|P1|Participant Flow|De Novo|De novo participants (those who did not participate in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
352467|NCT00365859|O4|Outcome|Total|
352468|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352469|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352470|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352471|NCT00365859|O4|Outcome|Total|
352472|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352473|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352474|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352475|NCT00365859|O4|Outcome|Total|
352476|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352477|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352478|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352479|NCT00365859|O4|Outcome|Total|
352480|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352481|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352482|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352483|NCT00365859|O4|Outcome|Total|
352484|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352485|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352486|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352487|NCT00365859|O4|Outcome|Total|
352488|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352489|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352490|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352491|NCT00365859|O4|Outcome|Total|
352492|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352493|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352494|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352497|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352498|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352499|NCT00365859|O4|Outcome|Total|
352500|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352501|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352502|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352503|NCT00365859|O4|Outcome|Total|
352504|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352505|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352506|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352507|NCT00365859|O4|Outcome|Total|
352508|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352509|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352510|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352511|NCT00365859|O4|Outcome|Total|
352512|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352513|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352514|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352515|NCT00365859|O4|Outcome|Total|
352516|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352517|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352518|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352519|NCT00365859|O4|Outcome|Total|
352520|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352521|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352522|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352523|NCT00365859|O4|Outcome|Total|
352524|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352525|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352526|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352527|NCT00365859|O4|Outcome|Total|
352528|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352529|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352530|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352531|NCT00365859|O4|Outcome|Total|
352532|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352533|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352534|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352535|NCT00365859|O4|Outcome|Total|
352536|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352537|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352538|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352539|NCT00365859|O4|Outcome|Total|
352540|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352541|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352542|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352543|NCT00365859|O4|Outcome|Total|
352544|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352545|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352546|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352547|NCT00365859|O4|Outcome|Total|
352548|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
352549|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
352550|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
352551|NCT00365859|E3|Reported Event|Roll Over Placebo|
352552|NCT00365859|E2|Reported Event|Roll Over Aripiprazole|
352553|NCT00365859|E1|Reported Event|De Novo|
352554|NCT00365872|B4|Baseline|Total|Total of all reporting groups
352555|NCT00365872|B3|Baseline|COHORT 3: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.
Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.
Radiation was delivered 5 days per week (Monday-Friday).
Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
352556|NCT00365872|B2|Baseline|COHORT 2: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.
Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.
Radiation was delivered 5 days per week (Monday-Friday).
Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
352619|NCT00366249|B2|Baseline|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
352557|NCT00365872|B1|Baseline|COHORT 1: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.
Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.
Radiation was delivered 5 days per week (Monday-Friday).
Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
352558|NCT00365872|P3|Participant Flow|COHORT 3: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.
Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.
Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
352576|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352577|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352578|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352579|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352580|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352581|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352559|NCT00365872|P2|Participant Flow|COHORT 2: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.
Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.
Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
352560|NCT00365872|P1|Participant Flow|COHORT 1: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.
Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.
Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
352561|NCT00365872|O3|Outcome|Single Arm - Cohort 3|DC injection # 4 given 72 hours prior to surgery
352562|NCT00365872|O2|Outcome|Single Arm - Cohort 2|DC injection # 4 given 48 hours prior to surgery
352563|NCT00365872|O1|Outcome|Single Arm - Cohort 1|DC injection # 4 given 24 hours prior to surgery
352564|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.
Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.
Radiation was delivered 5 days per week (Monday-Friday).
Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
352565|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.
Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.
Radiation was delivered 5 days per week (Monday-Friday).
Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
352566|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.
Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.
Radiation was delivered 5 days per week (Monday-Friday).
Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
352567|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.
Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.
Radiation was delivered 5 days per week (Monday-Friday).
Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
352620|NCT00366249|B1|Baseline|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
352621|NCT00366249|P2|Participant Flow|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
352622|NCT00366249|P1|Participant Flow|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
352568|NCT00365872|E1|Reported Event|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.
Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.
Radiation was delivered 5 days per week (Monday-Friday).
Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
352569|NCT00365976|B3|Baseline|Total|Total of all reporting groups
352570|NCT00365976|B2|Baseline|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352571|NCT00365976|B1|Baseline|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352572|NCT00365976|P2|Participant Flow|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352573|NCT00365976|P1|Participant Flow|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352574|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352575|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352582|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352583|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352584|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352585|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352586|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352587|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352588|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352589|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352590|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352591|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352592|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352593|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352594|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352595|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352596|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352597|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352598|NCT00365976|E2|Reported Event|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
352599|NCT00365976|E1|Reported Event|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
352600|NCT00366028|B3|Baseline|Total|Total of all reporting groups
352601|NCT00366028|B2|Baseline|Data Feedback|"Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.
Data Feedback Only Model: The research team will periodically interview the facilities and provide them with reported hand hygiene data."
352602|NCT00366028|B1|Baseline|Organizational Model|"Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.
Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
352603|NCT00366028|P2|Participant Flow|Data Feedback|"This arm is considered the control arm. Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.
Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
352604|NCT00366028|P1|Participant Flow|Organizational Model|"This arm is considered the intervention arm. Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.
Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two."
352623|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
352624|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
352625|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
352605|NCT00366028|O2|Outcome|Data Feedback|"Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model.
Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data.
The Control Arm included 9 study sites (medical centers) in total. Only 5 of the study sites are included in analysis of this outcome measure due to incomplete hand hygiene data at 4 of the study sites. Of the 5 study sites included, there were 2 sites with high fidelity to the Organization Model and 3 sites with low fidelity to the Organizational model, even though the model was not specifically introduced to the control arm."
352606|NCT00366028|O1|Outcome|Organizational Model|"Participants in this arm of the study received information regarding the organizational model and worked closely with the research team throughout the project to implement various aspects of the model.
Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.
The Intervention Arm included 7 study sites (medical centers). Of the 7 sites there were 4 with high fidelity to the Organizational Model and 3 with low fidelity to the Organizational Model."
352607|NCT00366028|O2|Outcome|Data Feedback|"Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model.
Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data.
The Control Arm included 735 individual participants across 9 study sites (medical centers) in total. Only 5 of the study sites are included in the reporting of outcome data due to incomplete data at 4 of the study sites."
352663|NCT00366340|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
353357|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
352608|NCT00366028|O1|Outcome|Organizational Model|"Participants in this arm of the study received information regarding the organizational model and worked closely with the research team throughout the project to implement various aspects of the model.
Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.
The Intervention Arm included 889 individual participants across 7 study sites (medical centers)."
352609|NCT00366028|E2|Reported Event|Data Feedback|"This arm is considered the control arm. Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.
Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
352610|NCT00366028|E1|Reported Event|Organizational Model|"This arm is considered the intervention arm. Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.
Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.
Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
352611|NCT00366106|B1|Baseline|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
352612|NCT00366106|P1|Participant Flow|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
352613|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
352614|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
352615|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
352616|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
352617|NCT00366106|E1|Reported Event|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
352618|NCT00366249|B3|Baseline|Total|Total of all reporting groups
355517|NCT00364949|P2|Participant Flow|PCOS|Polycystic Ovary Syndrome
352626|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
352627|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
352628|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
352629|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
352630|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
352631|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
352632|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
352633|NCT00366249|E2|Reported Event|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
352634|NCT00366249|E1|Reported Event|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
352707|NCT00366340|E6|Reported Event|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
352635|NCT00366275|B1|Baseline|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
352636|NCT00366275|P1|Participant Flow|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
352637|NCT00366275|O1|Outcome|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
352638|NCT00366275|E1|Reported Event|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
352639|NCT00366301|B5|Baseline|Total|Total of all reporting groups
352640|NCT00366301|B4|Baseline|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
352641|NCT00366301|B3|Baseline|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
352642|NCT00366301|B2|Baseline|Metformin Pill|Metformin pill
352643|NCT00366301|B1|Baseline|Placebo Pill|Placebo pill
352644|NCT00366301|P4|Participant Flow|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
352645|NCT00366301|P3|Participant Flow|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
352646|NCT00366301|P2|Participant Flow|Metformin Pill|Metformin pill
352647|NCT00366301|P1|Participant Flow|Placebo Pill|Placebo pill
352648|NCT00366301|O4|Outcome|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
352649|NCT00366301|O3|Outcome|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
352650|NCT00366301|O2|Outcome|Metformin Pill|Metformin pill
352651|NCT00366301|O1|Outcome|Placebo Pill|Placebo pill
352652|NCT00366301|E4|Reported Event|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
352653|NCT00366301|E3|Reported Event|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
352654|NCT00366301|E2|Reported Event|Metformin Pill|Metformin pill
352655|NCT00366301|E1|Reported Event|Placebo Pill|Placebo pill
352656|NCT00366340|B3|Baseline|Total|Total of all reporting groups
352657|NCT00366340|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
352784|NCT00366548|E2|Reported Event|13vPnC - P 80 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352658|NCT00366340|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
352659|NCT00366340|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
352660|NCT00366340|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
352661|NCT00366340|O2|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
352662|NCT00366340|O1|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
352664|NCT00366340|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
352665|NCT00366340|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
352666|NCT00366340|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
352667|NCT00366340|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
352668|NCT00366340|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
352669|NCT00366340|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
352670|NCT00366340|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
352671|NCT00366340|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
352672|NCT00366340|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
352673|NCT00366340|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
352674|NCT00366340|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
352675|NCT00366340|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
352676|NCT00366340|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
352677|NCT00366340|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
352678|NCT00366340|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
352679|NCT00366340|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
352680|NCT00366340|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
352681|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
352682|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
352683|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
352684|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
352685|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
352686|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
352687|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
352688|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
352689|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
352690|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
352691|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
352692|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
352693|NCT00366340|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
352694|NCT00366340|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
352695|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
352696|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
352697|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
352698|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
352699|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
352700|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
353158|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
352701|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
352702|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
352703|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
352704|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
352705|NCT00366340|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
352706|NCT00366340|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
352708|NCT00366340|E5|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
352709|NCT00366340|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected from approximately one month after dose 3 to toddler dose.
352710|NCT00366340|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from approximately one month after dose 3 to toddler dose.
352711|NCT00366340|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
352712|NCT00366340|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
352713|NCT00366444|B3|Baseline|Total|Total of all reporting groups
352714|NCT00366444|B2|Baseline|Placebo|Oral placebo capsule, every 6 hours
352715|NCT00366444|B1|Baseline|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352716|NCT00366444|P2|Participant Flow|Placebo|Oral placebo capsule, every 6 hours
352717|NCT00366444|P1|Participant Flow|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352718|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
352719|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352720|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
352721|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352722|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
352723|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352724|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
352725|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352726|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
352727|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352728|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
352729|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352730|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
352731|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352732|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
352733|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352734|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
352735|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352736|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
352737|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352738|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
352739|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352740|NCT00366444|E2|Reported Event|Placebo|Oral placebo capsule, every 6 hours
352741|NCT00366444|E1|Reported Event|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
352742|NCT00366457|B1|Baseline|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
352743|NCT00366457|P1|Participant Flow|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
352744|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
352745|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
352764|NCT00366548|O2|Outcome|13vPnC - P 80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).
352890|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352746|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
352747|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
352748|NCT00366457|E1|Reported Event|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
352749|NCT00366548|B3|Baseline|Total|Total of all reporting groups
352750|NCT00366548|B2|Baseline|13vPnC Without (-) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
352751|NCT00366548|B1|Baseline|13vPnC With (+) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
352752|NCT00366548|P2|Participant Flow|13vPnC Without (-) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
352753|NCT00366548|P1|Participant Flow|13vPnC With (+) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
352754|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at the 2 month visit, Pentaxim at the 3 and 4 month visits, and Priorix at 12 months of age (toddler dose).
352755|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant doses), and Priorix at 12 months of age (toddler dose).
352756|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352823|NCT00366678|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
352757|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352758|NCT00366548|O8|Outcome|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352759|NCT00366548|O7|Outcome|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352760|NCT00366548|O6|Outcome|13vPnC - P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
352761|NCT00366548|O5|Outcome|13vPnC + P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
352762|NCT00366548|O4|Outcome|13vPnC - P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
352763|NCT00366548|O3|Outcome|13vPnC + P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
353525|NCT00360555|B4|Baseline|Placebo|flibanserin: placebo
352765|NCT00366548|O1|Outcome|13vPnC + P80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age(infant series, Dose 1).
352766|NCT00366548|O8|Outcome|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
352767|NCT00366548|O7|Outcome|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
352768|NCT00366548|O6|Outcome|13vPnC - P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
352769|NCT00366548|O5|Outcome|13vPnC + P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
352770|NCT00366548|O4|Outcome|13vPnC - P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
352771|NCT00366548|O3|Outcome|13vPnC + P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
352772|NCT00366548|O2|Outcome|13vPnC - P 80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).
352773|NCT00366548|O1|Outcome|13vPnC + P80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age(infant series, Dose 1).
352774|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at the 2 month visit, Pentaxim at the 3 and 4 month visits, and Priorix at 12 months of age (toddler dose).
352775|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant doses), and Priorix at 12 months of age (toddler dose).
352776|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352777|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352778|NCT00366548|E8|Reported Event|13vPnC - P80 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352779|NCT00366548|E7|Reported Event|13vPnC + P80 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352780|NCT00366548|E6|Reported Event|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352781|NCT00366548|E5|Reported Event|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352782|NCT00366548|E4|Reported Event|13vPnC - P80 Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352783|NCT00366548|E3|Reported Event|13vPnC + P80 Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352952|NCT00367133|P3|Participant Flow|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352785|NCT00366548|E1|Reported Event|13vPnC + P80 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
352786|NCT00366626|B3|Baseline|Total|Total of all reporting groups
352787|NCT00366626|B2|Baseline|Placebo|
352788|NCT00366626|B1|Baseline|Naltrexone|
352789|NCT00366626|P2|Participant Flow|Placebo|
352790|NCT00366626|P1|Participant Flow|Naltrexone|
352791|NCT00366626|O4|Outcome|Placebo (asp40)|Subjects with asp40 OPRM1 SNP who got Placebo during he study
352792|NCT00366626|O3|Outcome|Placebo (asn40asn )|Subjects with asn40asn OPRM1 SNP who got Placebo during he study
352793|NCT00366626|O2|Outcome|Naltrexone (asp40)|Subjects with asp40 OPRM1 SNP who got Naltrexone during he study
352794|NCT00366626|O1|Outcome|Naltrexone (asn40asn)|Subjects with asn40asn OPRM1 SNP who got Naltrexone during he study
352795|NCT00366626|O4|Outcome|Placebo (asp40)|Subjects with asp40 OPRM1 SNP who got Placebo during he study
352796|NCT00366626|O3|Outcome|Placebo (asn40asn )|Subjects with asn40asn OPRM1 SNP who got Placebo during he study
352797|NCT00366626|O2|Outcome|Naltrexone (asp40)|Subjects with asp40 OPRM1 SNP who got Naltrexone during he study
352798|NCT00366626|O1|Outcome|Naltrexone (asn40asn)|Subjects with asn40asn OPRM1 SNP who got Naltrexone during he study
352799|NCT00366626|E2|Reported Event|Placebo|
352800|NCT00366626|E1|Reported Event|Naltrexone|
352801|NCT00366678|B3|Baseline|Total|Total of all reporting groups
352889|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352802|NCT00366678|B2|Baseline|7vPnC/7vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352803|NCT00366678|B1|Baseline|13vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352804|NCT00366678|P3|Participant Flow|7vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC)coadministered with Pentavac at 12 months of age (toddler dose).
352805|NCT00366678|P2|Participant Flow|7vPnC/7vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352806|NCT00366678|P1|Participant Flow|13vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352807|NCT00366678|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
352808|NCT00366678|O9|Outcome|7vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
352809|NCT00366678|O8|Outcome|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
352810|NCT00366678|O7|Outcome|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
352811|NCT00366678|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
352812|NCT00366678|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
352813|NCT00366678|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
352814|NCT00366678|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
352815|NCT00366678|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
352816|NCT00366678|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
352817|NCT00366678|O9|Outcome|7vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
352818|NCT00366678|O8|Outcome|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
352819|NCT00366678|O7|Outcome|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
352820|NCT00366678|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
352821|NCT00366678|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
352822|NCT00366678|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
353159|NCT00368069|O2|Outcome|Placebo|placebo
352824|NCT00366678|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
352825|NCT00366678|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
352826|NCT00366678|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
352827|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352828|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352829|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352830|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352831|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
354901|NCT00371540|E1|Reported Event|I Rountine Care|
352832|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352833|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352834|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352835|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352836|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352837|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352838|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352839|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
352840|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
352841|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
352842|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
352843|NCT00366678|O2|Outcome|7vPnC/13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
352844|NCT00366678|O1|Outcome|13vPnC/13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, 4, and 12 months of age.
352845|NCT00366678|O2|Outcome|7vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
352846|NCT00366678|O1|Outcome|13vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352847|NCT00366678|O6|Outcome|7vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
352848|NCT00366678|O5|Outcome|7vPnC/13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
352849|NCT00366678|O4|Outcome|7vPnC/7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
352850|NCT00366678|O3|Outcome|7vPnC/7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352851|NCT00366678|O2|Outcome|13vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
352852|NCT00366678|O1|Outcome|13vPnC/13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
353160|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
352853|NCT00366678|O3|Outcome|7vPnC Infant Series / 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
352854|NCT00366678|O2|Outcome|7vPnC Infant Series / 7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352855|NCT00366678|O1|Outcome|13vPnC Infant Series / 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352856|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352857|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352858|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352859|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
352860|NCT00366678|E10|Reported Event|7vPnC / 13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and at 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
352861|NCT00366678|E9|Reported Event|7vPnC / 7vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
352862|NCT00366678|E8|Reported Event|13vPnC / 13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
352863|NCT00366678|E7|Reported Event|7vPnC/ 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
352864|NCT00366678|E6|Reported Event|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
352865|NCT00366678|E5|Reported Event|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
352866|NCT00366678|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
352867|NCT00366678|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
352868|NCT00366678|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
352869|NCT00366678|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
352870|NCT00366899|B3|Baseline|Total|Total of all reporting groups
352871|NCT00366899|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
352872|NCT00366899|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
352873|NCT00366899|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
352874|NCT00366899|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
352875|NCT00366899|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
352876|NCT00366899|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
352877|NCT00366899|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352878|NCT00366899|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352879|NCT00366899|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
353161|NCT00368069|O2|Outcome|Placebo|placebo
352880|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352881|NCT00366899|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352882|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352883|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352884|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352885|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352886|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352887|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352888|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352891|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352892|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352893|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352894|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352895|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352896|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352897|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352898|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352899|NCT00366899|O2|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352900|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352901|NCT00366899|O2|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352902|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352903|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352904|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352905|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352906|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352907|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352908|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
352909|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352910|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
352911|NCT00366899|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
352912|NCT00366899|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
352913|NCT00366899|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
352914|NCT00366899|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
352915|NCT00366899|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
352916|NCT00366899|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
352917|NCT00366899|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
352953|NCT00367133|P2|Participant Flow|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352918|NCT00366899|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
352919|NCT00366899|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
352920|NCT00366899|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
352921|NCT00366899|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
352922|NCT00366899|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
352923|NCT00366899|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
352924|NCT00366899|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
352925|NCT00366899|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5mL dose of 7vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
352926|NCT00366899|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5mL dose of 13vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
352927|NCT00366899|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
352928|NCT00366899|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
352929|NCT00366899|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
352930|NCT00366899|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
352931|NCT00367055|B3|Baseline|Total|Total of all reporting groups
352932|NCT00367055|B2|Baseline|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
352933|NCT00367055|B1|Baseline|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
352934|NCT00367055|P2|Participant Flow|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
352935|NCT00367055|P1|Participant Flow|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
352936|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
352937|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
352938|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
352939|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
352940|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
352941|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
352942|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
352943|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
352944|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
352945|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
352946|NCT00367055|E2|Reported Event|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
352947|NCT00367055|E1|Reported Event|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
352948|NCT00367133|B4|Baseline|Total|Total of all reporting groups
352949|NCT00367133|B3|Baseline|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352950|NCT00367133|B2|Baseline|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352951|NCT00367133|B1|Baseline|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
353155|NCT00368069|O2|Outcome|Placebo|placebo
352954|NCT00367133|P1|Participant Flow|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352955|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352956|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352957|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352958|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352959|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352960|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352961|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352962|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352963|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352964|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352965|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352966|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352967|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352968|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352969|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352970|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352971|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352972|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352973|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352974|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352975|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352976|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352977|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352978|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352979|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352980|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352981|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352982|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352983|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352984|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352985|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352986|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352987|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352988|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352989|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352990|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352991|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352992|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352993|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352994|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352995|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352996|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
352997|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
352998|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
352999|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
353000|NCT00367133|E3|Reported Event|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
353001|NCT00367133|E2|Reported Event|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
353002|NCT00367133|E1|Reported Event|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
353003|NCT00367237|B3|Baseline|Total|Total of all reporting groups
353004|NCT00367237|B2|Baseline|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
353156|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
353005|NCT00367237|B1|Baseline|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
353006|NCT00367237|P2|Participant Flow|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
353007|NCT00367237|P1|Participant Flow|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
353008|NCT00367237|O2|Outcome|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
353009|NCT00367237|O1|Outcome|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
353010|NCT00367237|E2|Reported Event|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
353011|NCT00367237|E1|Reported Event|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
353012|NCT00367341|B3|Baseline|Total|Total of all reporting groups
353013|NCT00367341|B2|Baseline|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
353014|NCT00367341|B1|Baseline|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
353015|NCT00367341|P2|Participant Flow|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
353016|NCT00367341|P1|Participant Flow|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
353017|NCT00367341|O2|Outcome|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
353018|NCT00367341|O1|Outcome|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
353019|NCT00367341|O2|Outcome|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
353020|NCT00367341|O1|Outcome|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
353021|NCT00367341|E2|Reported Event|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
353022|NCT00367341|E1|Reported Event|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
353023|NCT00367380|B4|Baseline|Total|Total of all reporting groups
353024|NCT00367380|B3|Baseline|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL
418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
353025|NCT00367380|B2|Baseline|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR
414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
353026|NCT00367380|B1|Baseline|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM
413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
353027|NCT00367380|P3|Participant Flow|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL
418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
353028|NCT00367380|P2|Participant Flow|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR
414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
353029|NCT00367380|P1|Participant Flow|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM
413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
353030|NCT00367380|O3|Outcome|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL
418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
353031|NCT00367380|O2|Outcome|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR
414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
353032|NCT00367380|O1|Outcome|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM
413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
353033|NCT00367380|E3|Reported Event|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL
418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
353034|NCT00367380|E2|Reported Event|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR
414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
353035|NCT00367380|E1|Reported Event|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM
413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
353036|NCT00367432|B1|Baseline|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
353037|NCT00367432|P2|Participant Flow|Levetiracetam N01020 [NCT00160615]|N01020 [NCT00160615] was an open-label follow-up study to evaluate safety and efficacy of Levetiracetam.
353038|NCT00367432|P1|Participant Flow|Levetiracetam N01221 [NCT00280696]|N01221 [NCT00280696] was a double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluate the efficacy and safety of Levetiracetam.
353039|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
353040|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
353041|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
353042|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
353043|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
353044|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
353045|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
353046|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
353047|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
353048|NCT00367432|E1|Reported Event|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
353049|NCT00367484|B1|Baseline|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
353050|NCT00367484|P1|Participant Flow|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
353051|NCT00367484|O1|Outcome|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
353052|NCT00367484|E1|Reported Event|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
354902|NCT00371566|B3|Baseline|Total|Total of all reporting groups
353053|NCT00367601|B1|Baseline|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Erlotinib: Erlotinib 150 mg qd days 1-21
Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
353054|NCT00367601|P1|Participant Flow|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Erlotinib: Erlotinib 150 mg qd days 1-21
Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
353055|NCT00367601|O1|Outcome|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Erlotinib: Erlotinib 150 mg qd days 1-21
Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
353056|NCT00367601|O1|Outcome|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Erlotinib: Erlotinib 150 mg qd days 1-21
Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
353057|NCT00367601|O1|Outcome|Single Arm|Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
353058|NCT00367601|E1|Reported Event|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Erlotinib: Erlotinib 150 mg qd days 1-21
Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
353059|NCT00367640|B5|Baseline|Total|Total of all reporting groups
353060|NCT00367640|B4|Baseline|Placebo|Placebo tablet
353061|NCT00367640|B3|Baseline|500 IR|500 IR grass pollen allergen extract tablet
353062|NCT00367640|B2|Baseline|300 IR|300 IR grass pollen allergen extract tablet
353063|NCT00367640|B1|Baseline|100 IR|100 IR grass pollen allergen extract tablet
353064|NCT00367640|P4|Participant Flow|Placebo|Placebo tablet
353065|NCT00367640|P3|Participant Flow|500 IR|500 IR grass pollen allergen extract tablet
353066|NCT00367640|P2|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
353067|NCT00367640|P1|Participant Flow|100 IR|100 IR grass pollen allergen extract tablet
353068|NCT00367640|O4|Outcome|Placebo|Placebo tablet
353069|NCT00367640|O3|Outcome|500 IR|500 IR grass pollen allergen extract tablet
353070|NCT00367640|O2|Outcome|300 IR|300 IR grass pollen allergen extract tablet
353071|NCT00367640|O1|Outcome|100 IR|100 IR grass pollen allergen extract tablet
353072|NCT00367640|E4|Reported Event|Placebo|Placebo tablet
353073|NCT00367640|E3|Reported Event|100 IR|100 IR grass pollen allergen extract tablet
353074|NCT00367640|E2|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
353075|NCT00367640|E1|Reported Event|500 IR|500 IR grass pollen allergen extract tablet
353076|NCT00367679|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353077|NCT00367679|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353078|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353079|NCT00367679|O1|Outcome|Overall Study Arm|
353080|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353081|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353082|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353083|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353084|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
353085|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353086|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
353087|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
353088|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
353157|NCT00368069|O2|Outcome|Placebo|placebo
353089|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353090|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353091|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353092|NCT00367679|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
353093|NCT00367744|B3|Baseline|Total|Total of all reporting groups
353094|NCT00367744|B2|Baseline|Placebo|Placebo arm
353095|NCT00367744|B1|Baseline|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then the dose increased to 4mg twice daily for the remainder of the study (44 weeks)
353096|NCT00367744|P2|Participant Flow|Placebo|Placebo arm for the whole duration of the study
353097|NCT00367744|P1|Participant Flow|Rosiglitazone|Rosiglitazone 4 mg daily for 4 weeks then the dose was increased to 4mg twice daily for the remainder of the study (44 weeks)
353098|NCT00367744|O2|Outcome|Placebo|Placebo arm
353099|NCT00367744|O1|Outcome|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
353100|NCT00367744|O2|Outcome|Placebo|Placebo arm
353101|NCT00367744|O1|Outcome|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then BID for 44 weeks
353102|NCT00367744|E2|Reported Event|Placebo|Placebo arm
353103|NCT00367744|E1|Reported Event|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
353104|NCT00367770|B1|Baseline|Overall Study Arm|
353105|NCT00367770|P1|Participant Flow|Tracleer|The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
353106|NCT00367770|O1|Outcome|Overall Study Arm|
353107|NCT00367770|O1|Outcome|Overall Study Arm|
353108|NCT00367770|O1|Outcome|Overall Study Arm|
353109|NCT00367770|E1|Reported Event|Tracleer|The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
353110|NCT00367835|B3|Baseline|Total|Total of all reporting groups
353111|NCT00367835|B2|Baseline|Placebo|
353112|NCT00367835|B1|Baseline|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353113|NCT00367835|P2|Participant Flow|Placebo|
353114|NCT00367835|P1|Participant Flow|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353115|NCT00367835|O2|Outcome|Placebo|
353116|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353117|NCT00367835|O2|Outcome|Placebo|
353118|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353119|NCT00367835|O2|Outcome|Placebo|
353120|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353121|NCT00367835|O2|Outcome|Placebo|
353122|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353123|NCT00367835|O2|Outcome|Placebo|
353124|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353125|NCT00367835|O2|Outcome|Placebo|
353126|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353127|NCT00367835|O2|Outcome|Placebo|
353128|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353129|NCT00367835|O2|Outcome|Placebo|
353130|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353131|NCT00367835|O2|Outcome|Placebo|
353132|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353133|NCT00367835|O2|Outcome|Placebo|
353134|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353135|NCT00367835|O2|Outcome|Placebo|
353136|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353137|NCT00367835|E2|Reported Event|Placebo|
353138|NCT00367835|E1|Reported Event|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
353139|NCT00367991|B3|Baseline|Total|Total of all reporting groups
353140|NCT00367991|B2|Baseline|Placebo|Normal saline volume to match active treatment IV daily for 3 days
353141|NCT00367991|B1|Baseline|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
353142|NCT00367991|P2|Participant Flow|Placebo|Normal saline volume to match active treatment IV daily for 3 days
353143|NCT00367991|P1|Participant Flow|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
353144|NCT00367991|O2|Outcome|rHuEPO|recombinant human erythropoietin
353145|NCT00367991|O1|Outcome|Placebo|normal saline
353146|NCT00367991|E2|Reported Event|Placebo|Normal saline volume to match active treatment IV daily for 3 days
353147|NCT00367991|E1|Reported Event|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
353148|NCT00368069|B3|Baseline|Total|Total of all reporting groups
353149|NCT00368069|B2|Baseline|Placebo|placebo
353150|NCT00368069|B1|Baseline|Keppra®|Keppra® extended release formulation (XR)
353151|NCT00368069|P2|Participant Flow|Placebo|placebo
353152|NCT00368069|P1|Participant Flow|Keppra®|Keppra® extended release formulation (XR)
353153|NCT00368069|O2|Outcome|Placebo|placebo
353154|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
353162|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
353163|NCT00368069|O2|Outcome|Placebo|placebo
353164|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
353165|NCT00368069|E2|Reported Event|Placebo|placebo
353166|NCT00368069|E1|Reported Event|Keppra®|Keppra® extended release formulation (XR)
353167|NCT00368108|B4|Baseline|Total|Total of all reporting groups
353168|NCT00368108|B3|Baseline|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
353169|NCT00368108|B2|Baseline|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
353170|NCT00368108|B1|Baseline|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
353171|NCT00368108|P3|Participant Flow|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
353172|NCT00368108|P2|Participant Flow|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
353173|NCT00368108|P1|Participant Flow|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
353174|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
353175|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
353176|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
353177|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
353178|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
353179|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
353180|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
353181|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
353182|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
353183|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
353184|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
353185|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
353186|NCT00368108|E3|Reported Event|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
353187|NCT00368108|E2|Reported Event|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
353188|NCT00368108|E1|Reported Event|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
353189|NCT00359983|B4|Baseline|Total|Total of all reporting groups
353190|NCT00359983|B3|Baseline|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353191|NCT00359983|B2|Baseline|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353192|NCT00359983|B1|Baseline|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353294|NCT00360269|B3|Baseline|Total|Total of all reporting groups
353193|NCT00359983|P3|Participant Flow|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353194|NCT00359983|P2|Participant Flow|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353195|NCT00359983|P1|Participant Flow|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353196|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353197|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353198|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353355|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353199|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353200|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353201|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353202|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353203|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353204|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353205|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353206|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353207|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353208|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353209|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353210|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353211|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353212|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353213|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353214|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353215|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353216|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353295|NCT00360269|B2|Baseline|Placebo|Flexible dose up to 100mg/day
353217|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353218|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353219|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353220|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353221|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353222|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
356088|NCT00373334|B3|Baseline|Conservative Measures Only|
353223|NCT00359983|E3|Reported Event|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353224|NCT00359983|E2|Reported Event|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353225|NCT00359983|E1|Reported Event|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
353226|NCT00360009|B4|Baseline|Total|Total of all reporting groups
353227|NCT00360009|B3|Baseline|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353228|NCT00360009|B2|Baseline|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353229|NCT00360009|B1|Baseline|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353230|NCT00360009|P3|Participant Flow|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353231|NCT00360009|P2|Participant Flow|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353232|NCT00360009|P1|Participant Flow|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353233|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353234|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353235|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353236|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353237|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353238|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353239|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353240|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353241|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353242|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353243|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353244|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353245|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353246|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353247|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353248|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353249|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353250|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353251|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353252|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353253|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353254|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353255|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353256|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353257|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353258|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353259|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353356|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353260|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353261|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353262|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353263|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353264|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353265|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353266|NCT00360009|E3|Reported Event|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
353267|NCT00360009|E2|Reported Event|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
353268|NCT00360009|E1|Reported Event|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
353269|NCT00360126|B1|Baseline|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
353270|NCT00360126|P1|Participant Flow|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
353271|NCT00360126|O1|Outcome|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
353272|NCT00360126|E1|Reported Event|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
353273|NCT00360243|B5|Baseline|Total|Total of all reporting groups
353274|NCT00360243|B4|Baseline|Placebo|"twice daily for 24 weeks
placebo: placebo"
353275|NCT00360243|B3|Baseline|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks
flibanserin: Experimental: flibanserin 50mg b.i.d."
353276|NCT00360243|B2|Baseline|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks
flibanserin: Experimental: flibanserin 50mg qhs"
353277|NCT00360243|B1|Baseline|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks
flibanserin: Experimental: flibanserin 25 mg b.i.d"
353278|NCT00360243|P4|Participant Flow|Placebo|"twice daily for 24 weeks
placebo: placebo"
353279|NCT00360243|P3|Participant Flow|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks
flibanserin: Experimental: flibanserin 50mg b.i.d."
353280|NCT00360243|P2|Participant Flow|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks
flibanserin: Experimental: flibanserin 50mg qhs"
353281|NCT00360243|P1|Participant Flow|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks
flibanserin: Experimental: flibanserin 25 mg b.i.d"
353282|NCT00360243|O4|Outcome|Placebo|"twice daily for 24 weeks
placebo: placebo"
353283|NCT00360243|O3|Outcome|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks
flibanserin: Experimental: flibanserin 50mg b.i.d."
353284|NCT00360243|O2|Outcome|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks
flibanserin: Experimental: flibanserin 50mg qhs"
353285|NCT00360243|O1|Outcome|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks
flibanserin: Experimental: flibanserin 25 mg b.i.d"
353286|NCT00360243|O4|Outcome|Placebo|"twice daily for 24 weeks
placebo: placebo"
353287|NCT00360243|O3|Outcome|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks
flibanserin: Experimental: flibanserin 50mg b.i.d."
353288|NCT00360243|O2|Outcome|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks
flibanserin: Experimental: flibanserin 50mg qhs"
353289|NCT00360243|O1|Outcome|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks
flibanserin: Experimental: flibanserin 25 mg b.i.d"
353290|NCT00360243|E4|Reported Event|Placebo|"twice daily for 24 weeks
placebo: placebo"
353291|NCT00360243|E3|Reported Event|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks
flibanserin: Experimental: flibanserin 50mg b.i.d."
353292|NCT00360243|E2|Reported Event|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks
flibanserin: Experimental: flibanserin 50mg qhs"
353293|NCT00360243|E1|Reported Event|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks
flibanserin: Experimental: flibanserin 25 mg b.i.d"
353297|NCT00360269|P2|Participant Flow|Placebo|Flexible dose up to 100mg/day
353298|NCT00360269|P1|Participant Flow|Atomoxetine|Flexible dose up to 100mg/day
353299|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
353300|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
353301|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
353302|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
353303|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
353304|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
353305|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
353306|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
353307|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
353308|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
353309|NCT00360269|E2|Reported Event|Placebo|Flexible dose up to 100mg/day
353310|NCT00360269|E1|Reported Event|Atomoxetine|Flexible dose up to 100mg/day
353311|NCT00360282|B1|Baseline|All Study Participants|Includes participants (migraineurs) with and without vertigo
353312|NCT00360282|P4|Participant Flow|Without Vertigo; Rizatriptan - Placebo|These participants suffered from migraine without associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
356089|NCT00373334|B2|Baseline|Nizatidine 5.0 mg/kg b.i.d.|
353313|NCT00360282|P3|Participant Flow|With Vertigo; Rizatriptan - Placebo|These participants suffered from migraine and had associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
353314|NCT00360282|P2|Participant Flow|Without Vertigo; Placebo - Rizatriptan|These participants suffered from migraines but did not have associated dizziness/vertigo. This group received placebo on visit 1 and Rizatriptan on visit 2.
353315|NCT00360282|P1|Participant Flow|With Vertigo; Placebo-Rizatriptan|These participants suffered from migraines with associated dizziness/vertigo. They were given placebo on visit one and Rizatriptan on visit 2.
353316|NCT00360282|O2|Outcome|Placebo Visit|Participants were pre-treated with placebo prior to vestibular stimulation.
353317|NCT00360282|O1|Outcome|Rizatriptan Visit|Subjects were pre-treated with Rizatriptan prior to vestibular stimulation.
353318|NCT00360282|O2|Outcome|Placebo Visit|Participants were pre-treated with placebo prior to vestibular stimulation.
353319|NCT00360282|O1|Outcome|Rizatriptan Visit|Subjects were pre-treated with Rizatriptan prior to vestibular stimulation.
353320|NCT00360282|E4|Reported Event|With Vertigo; Rizatriptan|These participants suffered from migraines with associated dizziness/vertigo. They received Rizatriptan on one of the visits.
353321|NCT00360282|E3|Reported Event|With Vertigo; Placebo|These participants suffered from migraines with associated dizziness/vertigo. They received Placebo on one of the visits.
353322|NCT00360282|E2|Reported Event|Without Vertigo; Rizatriptan|These participants suffered from migraines but did not have associated dizziness/vertigo. They received Rizatriptan on one of the visits.
353323|NCT00360282|E1|Reported Event|Without Vertigo; Placebo|These participants suffered from migraines but did not have associated dizziness/vertigo. They received Placebo on one of the visits.
353324|NCT00360308|B4|Baseline|Total|Total of all reporting groups
353325|NCT00360308|B3|Baseline|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
353326|NCT00360308|B2|Baseline|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
353327|NCT00360308|B1|Baseline|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
353328|NCT00360308|P3|Participant Flow|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
353329|NCT00360308|P2|Participant Flow|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
353330|NCT00360308|P1|Participant Flow|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
353331|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
353332|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
353333|NCT00360308|O1|Outcome|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
353334|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
353335|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
353336|NCT00360308|O1|Outcome|Placebo|The total number of subjects reflects 1 fewer subject due to inavailability of the data
353337|NCT00360308|O3|Outcome|Perampanel|The total number of subjects reflects 3 fewer subjects due to inavailability of the data
353338|NCT00360308|O2|Outcome|Entacapone|The total number of subjects reflects 5 fewer subjects due to inavailability of the data
353339|NCT00360308|O1|Outcome|Placebo|The total number of subjects reflects 3 fewer subjects due to inavailability of the data
353340|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
353341|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
353342|NCT00360308|O1|Outcome|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
353343|NCT00360308|E3|Reported Event|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
353344|NCT00360308|E2|Reported Event|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
353345|NCT00360308|E1|Reported Event|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
353346|NCT00360334|B3|Baseline|Total|Total of all reporting groups
353347|NCT00360334|B2|Baseline|Insulin Glargine|dosing based on treat to target protocol
353348|NCT00360334|B1|Baseline|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353349|NCT00360334|P2|Participant Flow|Insulin Glargine|dosing based on treat to target protocol
353350|NCT00360334|P1|Participant Flow|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353351|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353352|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353353|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353354|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353358|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353359|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353360|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353361|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353362|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353363|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353364|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353365|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353366|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353367|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353368|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353369|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353370|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353371|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353372|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353373|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353374|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353375|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353376|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353377|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353378|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353379|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353380|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353381|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353382|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353383|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353384|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353385|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353386|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353387|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353388|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353389|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353390|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353391|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353392|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353393|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353394|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353395|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353396|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353397|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353398|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353399|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353400|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353401|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353402|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353403|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353404|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353405|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
353406|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353407|NCT00360334|E2|Reported Event|Insulin Glargine|dosing based on treat to target protocol
353408|NCT00360334|E1|Reported Event|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
353409|NCT00360360|B1|Baseline|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
353410|NCT00360360|P1|Participant Flow|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
353411|NCT00360360|O1|Outcome|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
353412|NCT00360360|O1|Outcome|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
353413|NCT00360360|E1|Reported Event|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
353414|NCT00360399|B4|Baseline|Total|Total of all reporting groups
353415|NCT00360399|B3|Baseline|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
353416|NCT00360399|B2|Baseline|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
353417|NCT00360399|B1|Baseline|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
353418|NCT00360399|P3|Participant Flow|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
353419|NCT00360399|P2|Participant Flow|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
353420|NCT00360399|P1|Participant Flow|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
353421|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
353422|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
353423|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
353424|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
353425|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
353426|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
353427|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
353428|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
353429|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
353430|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
353431|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
353432|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
353433|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
353434|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
353435|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
353436|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
353437|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
353438|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
353439|NCT00360399|E3|Reported Event|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
353440|NCT00360399|E2|Reported Event|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
353441|NCT00360399|E1|Reported Event|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
353442|NCT00360412|B3|Baseline|Total|Total of all reporting groups
353443|NCT00360412|B2|Baseline|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353444|NCT00360412|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353445|NCT00360412|P2|Participant Flow|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353446|NCT00360412|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353467|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353468|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353522|NCT00360529|E2|Reported Event|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
353447|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353448|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353449|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353450|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353451|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353452|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353453|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353454|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353455|NCT00360412|E2|Reported Event|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353456|NCT00360412|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
353457|NCT00360490|B3|Baseline|Total|Total of all reporting groups
353458|NCT00360490|B2|Baseline|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353459|NCT00360490|B1|Baseline|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353460|NCT00360490|P2|Participant Flow|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353461|NCT00360490|P1|Participant Flow|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353462|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353463|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353464|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353465|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353466|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353521|NCT00360529|E3|Reported Event|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
353469|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353470|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353471|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353472|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353473|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353474|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353475|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353476|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353477|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353478|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353479|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353480|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353481|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353482|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353483|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353484|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353485|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353486|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353487|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353488|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353489|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353490|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353491|NCT00360490|E2|Reported Event|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
353492|NCT00360490|E1|Reported Event|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
353493|NCT00360529|B4|Baseline|Total|Total of all reporting groups
353494|NCT00360529|B3|Baseline|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
353495|NCT00360529|B2|Baseline|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
353496|NCT00360529|B1|Baseline|Placebo|placebo at bedtime
353497|NCT00360529|P3|Participant Flow|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
353498|NCT00360529|P2|Participant Flow|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
353499|NCT00360529|P1|Participant Flow|Placebo|placebo at bedtime
353500|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
353501|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
353502|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
353503|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
353504|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
353505|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
353506|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
353507|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
353508|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
353509|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
353510|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
353511|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
353512|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
353513|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
353514|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
353515|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
353516|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
353517|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
353518|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
353519|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
353520|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
353523|NCT00360529|E1|Reported Event|Placebo|placebo at bedtime
353526|NCT00360555|B3|Baseline|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
353527|NCT00360555|B2|Baseline|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
353528|NCT00360555|B1|Baseline|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
353529|NCT00360555|P4|Participant Flow|Placebo|flibanserin: placebo
353530|NCT00360555|P3|Participant Flow|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
353531|NCT00360555|P2|Participant Flow|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
353532|NCT00360555|P1|Participant Flow|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
353533|NCT00360555|O4|Outcome|Placebo|flibanserin: placebo
353534|NCT00360555|O3|Outcome|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
353535|NCT00360555|O2|Outcome|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
353536|NCT00360555|O1|Outcome|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
353537|NCT00360555|O4|Outcome|Placebo|flibanserin: placebo
353538|NCT00360555|O3|Outcome|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
353539|NCT00360555|O2|Outcome|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
353540|NCT00360555|O1|Outcome|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
353541|NCT00360555|E4|Reported Event|Placebo|flibanserin: placebo
353542|NCT00360555|E3|Reported Event|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
353543|NCT00360555|E2|Reported Event|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
353544|NCT00360555|E1|Reported Event|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
353545|NCT00360568|B3|Baseline|Total|Total of all reporting groups
353546|NCT00360568|B2|Baseline|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353547|NCT00360568|B1|Baseline|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353548|NCT00360568|P2|Participant Flow|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353667|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
353668|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
353669|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus And Methotrexate
355518|NCT00364949|P1|Participant Flow|Control|Control
353549|NCT00360568|P1|Participant Flow|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received levodopa-carbidopa intestinal gel (LCIG), delivered through a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J), administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353550|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353551|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
356090|NCT00373334|B1|Baseline|Nizatidine 2.5 mg/kg b.i.d.|
353552|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353553|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353554|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353555|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353556|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353557|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353558|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353559|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353560|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353561|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
356168|NCT00373490|B3|Baseline|Total|Total of all reporting groups
353562|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353563|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353564|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353565|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353566|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353567|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353568|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353670|NCT00360685|E2|Reported Event|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
355519|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
353569|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353570|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353571|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353572|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353573|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353574|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353575|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353576|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353577|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353578|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353579|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353580|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353581|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353582|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353583|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353584|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353585|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353586|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353587|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353588|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
355520|NCT00364949|O1|Outcome|Control|Control
353589|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353590|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353591|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353592|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353593|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353594|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353595|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353596|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353597|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353598|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353671|NCT00360685|E1|Reported Event|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
353672|NCT00360698|B3|Baseline|Total|Total of all reporting groups
353599|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353600|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353601|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353602|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353603|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353604|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353605|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353606|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353607|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353608|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353609|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353610|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353611|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353612|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353613|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353614|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353615|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353616|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353617|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353618|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
355521|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
353619|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353620|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353621|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353622|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353623|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353624|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353625|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353626|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353627|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353628|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353789|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours
Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
353629|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353630|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353631|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353632|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353633|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353634|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353635|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353636|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353637|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353638|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353639|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353640|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353641|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353642|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353643|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353644|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353645|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353646|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353647|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353648|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
355522|NCT00364949|O1|Outcome|Control|Control
353649|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353650|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353651|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353652|NCT00360568|E3|Reported Event|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
353653|NCT00360568|E2|Reported Event|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
353654|NCT00360568|E1|Reported Event|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
353655|NCT00360672|B1|Baseline|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
353656|NCT00360672|P1|Participant Flow|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
353657|NCT00360672|O1|Outcome|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
353658|NCT00360672|E1|Reported Event|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
353659|NCT00360685|B3|Baseline|Total|Total of all reporting groups
353660|NCT00360685|B2|Baseline|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
353661|NCT00360685|B1|Baseline|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
353662|NCT00360685|P2|Participant Flow|Tacrolimus And Mycophenolate Mofetil|"All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day –3. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14).
MMF 30 mg/kg/day IV in 2 divided doses beginning day 0. Dosing should be based on the lesser of adjusted ideal body weight or actual body weight. The IV dose will be converted to the oral formulation when spatient is able to tolerate oral medications. Oral dosing may be capped at 1 gram twice daily. In the absence of GVHD a tapering schedule will begin on day +240 (+14) and be completed on day +360 (+14)."
353663|NCT00360685|P1|Participant Flow|Tacrolimus And Methotrexate|"All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day –3 (day 0 being the anticipated day of hematopoietic stem cell infusion). Tacrolimus dosing should be based on ideal body weight. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing at a 1:3 (IV:PO) ratio. The daily oral dose will be divided into twice daily dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14).
MTX 15 mg/m2 IV day +1 then 10 mg/m2 IV on days +3, +6, and +11."
353664|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
353665|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
353666|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
353673|NCT00360698|B2|Baseline|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353674|NCT00360698|B1|Baseline|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353675|NCT00360698|P2|Participant Flow|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353676|NCT00360698|P1|Participant Flow|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353677|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353678|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353679|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353809|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353810|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353680|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353681|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353682|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353683|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353684|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353685|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353686|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353687|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353688|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353689|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353690|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353691|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353692|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353693|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353694|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353695|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353696|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353697|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353698|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353790|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours
Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
353699|NCT00360698|E2|Reported Event|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353700|NCT00360698|E1|Reported Event|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
353701|NCT00360724|B3|Baseline|Total|Total of all reporting groups
353702|NCT00360724|B2|Baseline|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
353703|NCT00360724|B1|Baseline|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353704|NCT00360724|P2|Participant Flow|Placebo Treatment|placebo treatment, treatment with matching capsules of placebo
353705|NCT00360724|P1|Participant Flow|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353706|NCT00360724|O2|Outcome|Placebo Treatment|"placebo treatment: treatment with placebo capsules that match active medication capsules
Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day"
353707|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|"Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine
Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day"
353708|NCT00360724|O2|Outcome|Placebo Treatment|"placebo treatment: treatment with placebo capsules that match active medication capsules
Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day"
353709|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|"Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine
Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day"
353710|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
353711|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353712|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
353713|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353714|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
353715|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353716|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
353717|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353718|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
353719|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353720|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
353721|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353722|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
353723|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353724|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment, with capsules matching the duloxetine medication
353725|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353726|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment, with capsules matching the duloxetine medication
353727|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353728|NCT00360724|E2|Reported Event|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
353729|NCT00360724|E1|Reported Event|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
353730|NCT00360828|B1|Baseline|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
353731|NCT00360828|P1|Participant Flow|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
353732|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
353733|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
353734|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
353735|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
353736|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
353737|NCT00360828|E1|Reported Event|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
353738|NCT00360971|B3|Baseline|Total|Total of all reporting groups
353739|NCT00360971|B2|Baseline|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
353740|NCT00360971|B1|Baseline|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
353741|NCT00360971|P2|Participant Flow|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
353742|NCT00360971|P1|Participant Flow|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
353743|NCT00360971|O2|Outcome|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
353744|NCT00360971|O1|Outcome|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
353745|NCT00360971|E2|Reported Event|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
353746|NCT00360971|E1|Reported Event|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
353747|NCT00361140|B4|Baseline|Total|Total of all reporting groups
353748|NCT00361140|B3|Baseline|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
353749|NCT00361140|B2|Baseline|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
353750|NCT00361140|B1|Baseline|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
353751|NCT00361140|P3|Participant Flow|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
353752|NCT00361140|P2|Participant Flow|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
353753|NCT00361140|P1|Participant Flow|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
353754|NCT00361140|O3|Outcome|AUC 9000|Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
353755|NCT00361140|O2|Outcome|AUC 7500|Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
353756|NCT00361140|O1|Outcome|AUC 6000|Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
353757|NCT00361140|O3|Outcome|AUC 9000|Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
353758|NCT00361140|O2|Outcome|AUC 7500|Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
353759|NCT00361140|O1|Outcome|AUC 6000|Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
353760|NCT00361140|E3|Reported Event|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
353761|NCT00361140|E2|Reported Event|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
353762|NCT00361140|E1|Reported Event|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
353763|NCT00361218|B1|Baseline|Open-label SSRI|"citalopram or escitalopram
open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
353764|NCT00361218|P1|Participant Flow|Open-label Selective Serotonin Reuptake Inhibitor (SSRI)|"citalopram or escitalopram
open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
353765|NCT00361218|O1|Outcome|Open-label Selective Serotonin Reuptake Inhibitor (SSRI)|"citalopram or escitalopram
open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
353791|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353792|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353793|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353766|NCT00361218|E1|Reported Event|Open-label SSRI|"citalopram or escitalopram
open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
353767|NCT00361231|B1|Baseline|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects."
353811|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353812|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353813|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353814|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353815|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353816|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353768|NCT00361231|P1|Participant Flow|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects."
353769|NCT00361231|O1|Outcome|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of studytreatment.
Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Oxaliplatin"
353770|NCT00361231|O1|Outcome|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of studytreatment.
Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Oxaliplatin"
353771|NCT00361231|E1|Reported Event|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side eff"
353772|NCT00361257|B3|Baseline|Total|Total of all reporting groups
353773|NCT00361257|B2|Baseline|Matching Placebo|Placebo taken orally every 12 hours
353774|NCT00361257|B1|Baseline|Minocycline|100 mg orally every 12 hours
353775|NCT00361257|P2|Participant Flow|Matching Placebo|Placebo taken orally every 12 hours
353776|NCT00361257|P1|Participant Flow|Minocycline|100 mg orally every 12 hours
353777|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353778|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353779|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353780|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353781|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353782|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353783|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours
Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
353784|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours
Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
353785|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours
Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
353786|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours
Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
353787|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours
Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
353788|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours
Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
353794|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353795|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353796|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353797|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353798|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353799|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353800|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353801|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353802|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353803|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353804|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353805|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353806|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353807|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353808|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353817|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353818|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353819|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353820|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353821|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353822|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353823|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
353824|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
353825|NCT00361257|E2|Reported Event|Matching Placebo|Placebo taken orally every 12 hours
353826|NCT00361257|E1|Reported Event|Minocycline|100 mg orally every 12 hours
353827|NCT00361270|B5|Baseline|Total|Total of all reporting groups
353828|NCT00361270|B4|Baseline|Arm 4|"Single-site study at MEDVA-Houston
EMG Biofeedback without hypnotic suggestion: 8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion"
353829|NCT00361270|B3|Baseline|Arm 3|"Single-site study at MEDVA-Houston
Home practice with hypnosis CDs: 2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs"
353830|NCT00361270|B2|Baseline|Arm 2|"Single-site study at MEDVA-Houston
Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis with home practice with hypnosis CDs"
353831|NCT00361270|B1|Baseline|Arm 1|"Single-site study at MEDVA-Houston
Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis"
353832|NCT00361270|P4|Participant Flow|Biofeedback - 8|8 sessions biofeedback
353833|NCT00361270|P3|Participant Flow|Hypnosis Practice 2|2 sessions of hypnosis with practice cds
353834|NCT00361270|P2|Participant Flow|Hypnosis-Practice 8|8 sessions hypnosis with practice cds
353835|NCT00361270|P1|Participant Flow|Hypnosis-8|8 sessions of hypnosis with no practice cds
353836|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback no recordings
353837|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist and audio recordings
353838|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapist and audio recordings
353839|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis without audio recordings
353840|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback without recordings
353841|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist with audio recordings
353842|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapists with audio recordings
353843|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis with hypnotherapist without recordings
353844|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback
353845|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions of hypnosis with audio recordings
353846|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions of hypnosis with audio recordings
353847|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis without audio recordings
353848|NCT00361270|E4|Reported Event|Biofeedback - 8|8 1-hour sessions of EMG biofeedback without recordings
353849|NCT00361270|E3|Reported Event|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist with audio recordings
353850|NCT00361270|E2|Reported Event|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapist with audio recordings
353851|NCT00361270|E1|Reported Event|Hypnosis-8|8 1-hour sessions with hypnotherapist
353852|NCT00361283|B1|Baseline|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
353853|NCT00361283|P1|Participant Flow|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
353854|NCT00361283|O1|Outcome|Atorvastatin 80 MG/Day|Atorvastatin 80 MG/day
353855|NCT00361283|E1|Reported Event|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
353856|NCT00361335|B6|Baseline|Total|Total of all reporting groups
353878|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
353879|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
355523|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
353857|NCT00361335|B5|Baseline|IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
353858|NCT00361335|B4|Baseline|4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
353859|NCT00361335|B3|Baseline|4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
353860|NCT00361335|B2|Baseline|2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
353887|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
353861|NCT00361335|B1|Baseline|2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
353862|NCT00361335|P7|Participant Flow|EE/DRA -> 4mg/kg Golimumab + MTX|At Week 16 and Week 24 participants entered EE and DRA, respectively, depending on joint assessment results and received IV infusions of 4mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
353863|NCT00361335|P6|Participant Flow|EE/DRA -> 2mg/kg Golimumab + MTX|At Week 16 and Week 24 participants entered early escape (EE) and dose regimen adjustment (DRA), respectively, depending on joint assessment results and received IV infusions of 2mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
353864|NCT00361335|P5|Participant Flow|IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
353865|NCT00361335|P4|Participant Flow|4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
353866|NCT00361335|P3|Participant Flow|4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
353867|NCT00361335|P2|Participant Flow|2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
353868|NCT00361335|P1|Participant Flow|2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
353869|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
353870|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
353871|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
353872|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
353873|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
353874|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
353875|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
353876|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
353877|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
354384|NCT00369967|B3|Baseline|Total|Total of all reporting groups
353880|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
353881|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
353882|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
353883|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
353884|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
353885|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
353886|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
354055|NCT00368316|B3|Baseline|Total|Total of all reporting groups
353888|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
353889|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
353890|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
353891|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
353892|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
353893|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
353894|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
353895|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
353896|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
353897|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
353898|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
353899|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
353900|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
353901|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
353902|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
353903|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
353904|NCT00361335|E7|Reported Event|SC Period: 50mg Golimumab Only|Participants who received 50mg golimumab only. Participants must not have received any MTX while receiving 50mg SC golimumab.
353905|NCT00361335|E6|Reported Event|SC Period: 50mg Golimumab + MTX|Participants who received 50mg SC golimumab and MTX.
353906|NCT00361335|E5|Reported Event|IV Period: Placebo + MTX|Participants who received IV placebo and MTX only. Follow-up time was counted in this group until the participant started to receive IV golimumab.
353907|NCT00361335|E4|Reported Event|IV Period: 4mg/kg Golimumab Only|Participants who received at least one 4mg/kg IV golimumab dose. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 4mg/kg IV golimumab.
353908|NCT00361335|E3|Reported Event|IV Period: 4mg/kg Golimumab + MTX|Participants who received at least one 4 mg/kg IV golimumab dose and MTX. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 4mg/kg IV golimumab.
353909|NCT00361335|E2|Reported Event|IV Period: 2mg/kg Golimumab Only|Participants who received 2mg/kg IV golimumab only. Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 2mg/kg IV golimumab.
353910|NCT00361335|E1|Reported Event|IV Period: 2mg/kg Golimumab+ MTX|Participants who received 2mg/kg IV golimumab and methotrexate (MTX). Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 2mg/kg IV golimumab and before receiving 4mg/kg IV golimumab
353911|NCT00361374|B4|Baseline|Total|Total of all reporting groups
353912|NCT00361374|B3|Baseline|Placebo|"Placebo capsule (980mg soybean oil)
Placebo: 980 milligram/day"
353913|NCT00361374|B2|Baseline|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day
docosahexaenoic acid: 1 gram/day"
353914|NCT00361374|B1|Baseline|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day
eicosapentaenoic acid: 1 gram/day"
353915|NCT00361374|P3|Participant Flow|Placebo|"Placebo capsule (980mg soybean oil)
Placebo: 980 milligram/day"
353916|NCT00361374|P2|Participant Flow|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day
docosahexaenoic acid: 1 gram/day"
353917|NCT00361374|P1|Participant Flow|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day
eicosapentaenoic acid: 1 gram/day"
353918|NCT00361374|O3|Outcome|Placebo|"Placebo capsule (980mg soybean oil)
Placebo: 980 milligram/day"
353919|NCT00361374|O2|Outcome|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day
docosahexaenoic acid: 1 gram/day"
353920|NCT00361374|O1|Outcome|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day
eicosapentaenoic acid: 1 gram/day"
353921|NCT00361374|E3|Reported Event|Placebo|"Placebo capsule (980mg soybean oil)
Placebo: 980 milligram/day"
353922|NCT00361374|E2|Reported Event|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day
docosahexaenoic acid: 1 gram/day"
353923|NCT00361374|E1|Reported Event|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day
eicosapentaenoic acid: 1 gram/day"
353924|NCT00361439|B3|Baseline|Total|Total of all reporting groups
353925|NCT00361439|B2|Baseline|Placebo|2 puffs of placebo spray once daily
353926|NCT00361439|B1|Baseline|Mometasone|Active intranasal steroid therapy daily for 2 weeks
353927|NCT00361439|P2|Participant Flow|Placebo|2 puffs of placebo spray once daily
353928|NCT00361439|P1|Participant Flow|Mometasone|Active intranasal steroid therapy daily for 2 weeks
353929|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
353930|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
353931|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
353932|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
353933|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
353934|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
353935|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
353936|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
353937|NCT00361439|E2|Reported Event|Placebo|2 puffs of placebo spray once daily
353938|NCT00361439|E1|Reported Event|Mometasone|Active intranasal steroid therapy daily for 2 weeks
353939|NCT00361504|B3|Baseline|Total|Total of all reporting groups
353940|NCT00361504|B2|Baseline|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
353941|NCT00361504|B1|Baseline|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
353942|NCT00361504|P2|Participant Flow|Oxycodone|Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.
353943|NCT00361504|P1|Participant Flow|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year
353944|NCT00361504|O2|Outcome|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
353945|NCT00361504|O1|Outcome|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
353946|NCT00361504|O2|Outcome|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
353947|NCT00361504|O1|Outcome|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
353948|NCT00361504|E2|Reported Event|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
353949|NCT00361504|E1|Reported Event|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
353950|NCT00361569|B5|Baseline|Total|Total of all reporting groups
353951|NCT00361569|B4|Baseline|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353952|NCT00361569|B3|Baseline|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353953|NCT00361569|B2|Baseline|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353954|NCT00361569|B1|Baseline|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353955|NCT00361569|P4|Participant Flow|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353956|NCT00361569|P3|Participant Flow|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353957|NCT00361569|P2|Participant Flow|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353958|NCT00361569|P1|Participant Flow|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353959|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353960|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353961|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353962|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353963|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353964|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353965|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353966|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353967|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353968|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353969|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353970|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353971|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353972|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353973|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353974|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353975|NCT00361569|E4|Reported Event|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353976|NCT00361569|E3|Reported Event|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353977|NCT00361569|E2|Reported Event|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
353978|NCT00361569|E1|Reported Event|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
353979|NCT00361595|B1|Baseline|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
353980|NCT00361595|P1|Participant Flow|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
353981|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
353982|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
353983|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
353984|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
353985|NCT00361595|E1|Reported Event|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
353986|NCT00361634|B1|Baseline|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353987|NCT00361634|P1|Participant Flow|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353988|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353989|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353990|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353991|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353992|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353993|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353994|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353995|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353996|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353997|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353998|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
353999|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
354000|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
354001|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
354002|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
354003|NCT00361634|E1|Reported Event|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
354004|NCT00368251|B4|Baseline|Total Title|
354005|NCT00368251|B3|Baseline|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
354006|NCT00368251|B2|Baseline|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
354007|NCT00368251|B1|Baseline|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
354008|NCT00368251|P3|Participant Flow|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
354009|NCT00368251|P2|Participant Flow|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
354010|NCT00368251|P1|Participant Flow|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
354011|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
354012|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
354013|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
354014|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
354015|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
354016|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
354017|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
354018|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
354019|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
354020|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
354021|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
354022|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
354023|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
354024|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
354025|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
354026|NCT00368251|E3|Reported Event|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
354027|NCT00368251|E2|Reported Event|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
354028|NCT00368251|E1|Reported Event|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
354029|NCT00368277|B3|Baseline|Total|Total of all reporting groups
354030|NCT00368277|B2|Baseline|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
354031|NCT00368277|B1|Baseline|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
354032|NCT00368277|P2|Participant Flow|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
354033|NCT00368277|P1|Participant Flow|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
354034|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
354035|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
354036|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
354037|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
354038|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
354039|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
354040|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
354041|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
354042|NCT00368277|E2|Reported Event|Ramipril|Ramipril based regimen
354043|NCT00368277|E1|Reported Event|Aliskiren|Aliskiren based regimen
354044|NCT00368290|B3|Baseline|Total|Total of all reporting groups
354045|NCT00368290|B2|Baseline|Placebo|"placebo plus CBT
placebo: placebo pills for 8 weeks
Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
354046|NCT00368290|B1|Baseline|Modafinil|"modafinil plus CBT
Modafinil: 300mg a day for 8 weeks
Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
354047|NCT00368290|P2|Participant Flow|Placebo|"placebo plus CBT
placebo: placebo pills for 8 weeks
Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
354048|NCT00368290|P1|Participant Flow|Modafinil|"modafinil plus CBT
Modafinil: 300mg a day for 8 weeks
Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
354049|NCT00368290|O2|Outcome|Placebo|"placebo plus CBT
placebo: placebo pills for 8 weeks
Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
354050|NCT00368290|O1|Outcome|Modafinil|"modafinil plus CBT
Modafinil: 300mg a day for 8 weeks
Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
354051|NCT00368290|O2|Outcome|Placebo|"placebo plus CBT
placebo: placebo pills for 8 weeks
Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
354052|NCT00368290|O1|Outcome|Modafinil|"modafinil plus CBT
Modafinil: 300mg a day for 8 weeks
Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
354053|NCT00368290|E2|Reported Event|Placebo|"placebo plus CBT
placebo: placebo pills for 8 weeks
Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
354054|NCT00368290|E1|Reported Event|Modafinil|"modafinil plus CBT
Modafinil: 300mg a day for 8 weeks
Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
354056|NCT00368316|B2|Baseline|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354057|NCT00368316|B1|Baseline|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354058|NCT00368316|P2|Participant Flow|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354059|NCT00368316|P1|Participant Flow|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354060|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354061|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354062|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354063|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354064|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354065|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354066|NCT00368316|E2|Reported Event|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354067|NCT00368316|E1|Reported Event|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
354068|NCT00369681|B1|Baseline|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
354069|NCT00369681|P1|Participant Flow|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
354070|NCT00369681|O1|Outcome|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
354071|NCT00369681|O2|Outcome|Re-emergence of Clone|Participants who did have re-emergence of clonal CD27(+) ALDH(+) B cells
354072|NCT00369681|O1|Outcome|No Clone|Participants who did not have re-emergence of clonal CD27(+) ALDH(+) B cells
354073|NCT00369681|E1|Reported Event|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
354074|NCT00369746|B3|Baseline|Total|Total of all reporting groups
354075|NCT00369746|B2|Baseline|Major Depression Only|Major Depression without alcohol abuse disorder
354076|NCT00369746|B1|Baseline|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence
354077|NCT00369746|P2|Participant Flow|Major Depression Only|Major Depression without alcohol abuse disorder
354078|NCT00369746|P1|Participant Flow|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence and Major Depression
354079|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
354080|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
354081|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
354082|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
354083|NCT00369746|O2|Outcome|Major Depression Only|citalopram (Non alcoholic)
354084|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
354085|NCT00369746|E2|Reported Event|Major Depression Only|Major Depression without alcohol abuse disorder
354086|NCT00369746|E1|Reported Event|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence
354087|NCT00369785|B3|Baseline|Total|Total of all reporting groups
354088|NCT00369785|B2|Baseline|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day
Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
354089|NCT00369785|B1|Baseline|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day
donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
354090|NCT00369785|P2|Participant Flow|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day
Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
354091|NCT00369785|P1|Participant Flow|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day
donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
354092|NCT00369785|O2|Outcome|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day
Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
354137|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354093|NCT00369785|O1|Outcome|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day
donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
354094|NCT00369785|O2|Outcome|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day
Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
354095|NCT00369785|O1|Outcome|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day
donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
354096|NCT00369785|E2|Reported Event|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day
Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
354097|NCT00369785|E1|Reported Event|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day
donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
354098|NCT00369824|B7|Baseline|Total|Total of all reporting groups
354099|NCT00369824|B6|Baseline|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354100|NCT00369824|B5|Baseline|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354101|NCT00369824|B4|Baseline|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354102|NCT00369824|B3|Baseline|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354103|NCT00369824|B2|Baseline|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354104|NCT00369824|B1|Baseline|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354105|NCT00369824|P6|Participant Flow|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354106|NCT00369824|P5|Participant Flow|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354107|NCT00369824|P4|Participant Flow|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354108|NCT00369824|P3|Participant Flow|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354109|NCT00369824|P2|Participant Flow|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354110|NCT00369824|P1|Participant Flow|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354111|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354112|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354113|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354114|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354115|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354116|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354117|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354118|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354119|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354120|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354121|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354122|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354123|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354124|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354125|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354126|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354127|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354128|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354129|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354130|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354131|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354132|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354133|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354134|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354135|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354136|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354138|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354139|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354140|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354141|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354142|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354143|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354144|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354145|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354146|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354147|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354148|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354149|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354150|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354151|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354152|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354153|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354154|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354155|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354156|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354157|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354158|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354159|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354160|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354161|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354162|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354163|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354164|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354165|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354166|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354167|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354168|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354169|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354170|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354171|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354172|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354173|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354174|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354175|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354176|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354177|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354178|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354179|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354180|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354181|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354182|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354183|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354184|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354185|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354186|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354187|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354188|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354189|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354190|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354191|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354192|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354193|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354194|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354195|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354196|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354197|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354198|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354199|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354200|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354201|NCT00369824|E6|Reported Event|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
354202|NCT00369824|E5|Reported Event|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
354203|NCT00369824|E4|Reported Event|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
354204|NCT00369824|E3|Reported Event|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
354205|NCT00369824|E2|Reported Event|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
354206|NCT00369824|E1|Reported Event|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
354207|NCT00369915|B3|Baseline|Total|Total of all reporting groups
354208|NCT00369915|B2|Baseline|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
354209|NCT00369915|B1|Baseline|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
354210|NCT00369915|P2|Participant Flow|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
354211|NCT00369915|P1|Participant Flow|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
354212|NCT00369915|O2|Outcome|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
354213|NCT00369915|O1|Outcome|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
354214|NCT00369915|O2|Outcome|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
354385|NCT00369967|B2|Baseline|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
354215|NCT00369915|O1|Outcome|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
354216|NCT00369915|E2|Reported Event|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
354217|NCT00369915|E1|Reported Event|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
354218|NCT00369928|B4|Baseline|Total|Total of all reporting groups
354219|NCT00369928|B3|Baseline|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
354220|NCT00369928|B2|Baseline|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
354221|NCT00369928|B1|Baseline|Placebo|Placebo, oral dose, BID
354222|NCT00369928|P3|Participant Flow|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
354223|NCT00369928|P2|Participant Flow|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
354224|NCT00369928|P1|Participant Flow|Placebo|Placebo, oral dose, BID
354225|NCT00369928|O3|Outcome|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
354226|NCT00369928|O2|Outcome|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
354227|NCT00369928|O1|Outcome|Placebo|Placebo, oral dose, BID
354228|NCT00369928|E3|Reported Event|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
354229|NCT00369928|E2|Reported Event|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
354230|NCT00369928|E1|Reported Event|Placebo|Placebo, oral dose, BID
354231|NCT00369941|B3|Baseline|Total|Total of all reporting groups
354645|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354232|NCT00369941|B2|Baseline|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354233|NCT00369941|B1|Baseline|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354234|NCT00369941|P2|Participant Flow|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354235|NCT00369941|P1|Participant Flow|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354236|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354237|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354238|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354239|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354240|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354241|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354242|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
355524|NCT00364949|O1|Outcome|Control|Control
354243|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354244|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354245|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354438|NCT00370071|E1|Reported Event|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354439|NCT00370149|B3|Baseline|Total|Total of all reporting groups
354646|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354246|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354247|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354248|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354249|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354250|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354251|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354252|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354253|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354254|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354255|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354256|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354386|NCT00369967|B1|Baseline|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
354387|NCT00369967|P2|Participant Flow|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
354388|NCT00369967|P1|Participant Flow|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
355525|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
354257|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354258|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354259|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354260|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354261|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354262|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354263|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354264|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354265|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354266|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354267|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354268|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354269|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354270|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354389|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
354390|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
354391|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
355526|NCT00364949|O1|Outcome|Control|Control
354271|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354272|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354273|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354274|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354275|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354276|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354277|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354278|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354279|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354280|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354281|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354282|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354283|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354284|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354392|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
354393|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
354394|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
355527|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
354285|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354286|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354287|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354288|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354289|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354290|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354291|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354292|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354293|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354294|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354295|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354296|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354297|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354298|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354395|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
354396|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
354397|NCT00369967|O2|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
355528|NCT00364949|O1|Outcome|Control|Control
354299|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354300|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354301|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354302|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354303|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354304|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354305|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354306|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354307|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354308|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354309|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354310|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354311|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354312|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354398|NCT00369967|O1|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
354399|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception
354400|NCT00369967|O1|Outcome|Quick Start|"Start method day of enrollment
NuvaRing: Initiation of NuvaRing for contraception"
355529|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
354313|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354314|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354315|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354316|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354317|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354318|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354319|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354320|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354321|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354322|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354323|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354324|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354325|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354326|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354401|NCT00369967|E2|Reported Event|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
354402|NCT00369967|E1|Reported Event|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
354403|NCT00370032|B3|Baseline|Total|Total of all reporting groups
355502|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
354327|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354328|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354329|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354330|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354331|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354332|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354333|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354334|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354335|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354336|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354337|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354338|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354339|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354340|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354404|NCT00370032|B2|Baseline|Healthy Volunteers|Volunteers without clinical disease. This group was randomize to EITHER 0.5 mb BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another wash out period and a 7 day follow up period.
354341|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354342|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354343|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
356757|NCT00369226|B3|Baseline|Total|Total of all reporting groups
354344|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354345|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354346|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354347|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354348|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354349|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354350|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354351|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354352|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354353|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354354|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354405|NCT00370032|B1|Baseline|d-IBS|Diarrhea-predominant irritable bowel syndrome. This group was randomize to EITHER 0.5 mb BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another wash out period and a 7 day follow up period.
355530|NCT00364949|O1|Outcome|Control|Control
354355|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354356|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354357|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354358|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354359|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354360|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354361|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354362|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354363|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354364|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354365|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354366|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354367|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354368|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354406|NCT00370032|P2|Participant Flow|Healthy Volunteers|Subjects with no clinical disease. This group was randomize to EITHER 0.5 mg BID Alosetron or Placebo for 6 days followed by flexible sigmoidoscopy then had a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
354369|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354370|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354371|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
356758|NCT00369226|B2|Baseline|Phase II|
354372|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354373|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354374|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354375|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354376|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354377|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354378|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354379|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354380|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354381|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354382|NCT00369941|E2|Reported Event|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg taken by mouth on an empty stomach preferably at bedtime (q.h.s.), and placebo to MK-0518 taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354383|NCT00369941|E1|Reported Event|MK-0518 400 mg b.i.d.|MK-0518 400 mg taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, taken PO (q.h.s.) on an empty stomach preferably at bedtime (q.h.s.). All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) daily with food with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
354407|NCT00370032|P1|Participant Flow|d-IBS (Diarrhea Predominant - Irritable Bowel Syndrome)|Subjects with diarrhea-predominant irritable bowel syndrome. This group was randomize to EITHER 0.5 mg BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by a flexible sigmoidoscopy then had a 7 day follow up period.
354408|NCT00370032|O4|Outcome|Healthy Volunteers Placebo - Rectal|Subjects without clinical disease. Modified per protocol. Subjects Rectal Mucosal blow flow under placebo.
354409|NCT00370032|O3|Outcome|Healthy Volunteers Placebo - Left Colon|Subjects without Clinical disease. Modified per protocol. Subjects Left Colon Mucosal blow flow under placebo.
354410|NCT00370032|O2|Outcome|d-IBS Placebo - Rectal|Subjects with diarrhea-predominant irritable bowel syndrome. Modified per protocol. Subjects Rectal Mucosal blow flow under placebo.
354411|NCT00370032|O1|Outcome|d-IBS Placebo - Left Colon|Subjects with diarrhea-predominant irritable bowel syndrome . Modified per protocol. Subjects Left Colon Mucosal blow flow under placebo.
354562|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354412|NCT00370032|O4|Outcome|Healthy Volunteers Alosetron|Subjects without clinical disease. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then,in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
354413|NCT00370032|O3|Outcome|Healthy Volunteers Placebo|Subjects without Clinical disease. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
354414|NCT00370032|O2|Outcome|d-IBS Alosetron|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
354415|NCT00370032|O1|Outcome|d-IBS Placebo|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
354416|NCT00370032|O4|Outcome|Healthy Volunteers Alosetron|Subjects without clinical disease. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then,in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
354417|NCT00370032|O3|Outcome|Healthy Volunteers Placebo|Subjects without Clinical disease. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
354418|NCT00370032|O2|Outcome|d-IBS Alosetron|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1, this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
354419|NCT00370032|O1|Outcome|d-IBS Placebo|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
354420|NCT00370032|E4|Reported Event|Healthy Volunteers Alosetron|Volunteers without clinical disease. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
354421|NCT00370032|E3|Reported Event|Healthy Volunteers Placebo|Volunteers without clinical disease. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
354422|NCT00370032|E2|Reported Event|d-IBS Alosetron|Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
354423|NCT00370032|E1|Reported Event|d-IBS Placebo|Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
354424|NCT00370071|B1|Baseline|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 micrograms (8 MIU [million international units]) subcutaneously every other day.
354425|NCT00370071|P1|Participant Flow|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354426|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354427|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354428|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354429|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354430|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
355503|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
354431|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354432|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354433|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354434|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354435|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354436|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354437|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
354647|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354440|NCT00370149|B2|Baseline|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), or 5 Fr., 12 cm long, (C-UDLM-501J RSC).
354441|NCT00370149|B1|Baseline|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were sized to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM) and C-UDLM-401J-ABRM-HC), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC).
354442|NCT00370149|P2|Participant Flow|Conventional Non-impregnated Catheters (C/S)|Randomization to 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to this arm had the conventional Central Venous Catheter (C/S) with no antibiotic coating inserted intraoperatively. The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), and 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
354443|NCT00370149|P1|Participant Flow|Antibiotic Impregnated Catheters (M/R)|Randomization to the 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to M/R had the catheter impregnated with minocycline and rifampin (M/R) inserted intraoperatively. The specific Central Venous Catheters are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
354444|NCT00370149|O2|Outcome|Conventional Non-impegnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J) 5 Fr.,12 cm long, (C-UDLM-501J-RSC).
354445|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), ), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC) or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
354446|NCT00370149|O2|Outcome|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
354447|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), ), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC) or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
354448|NCT00370149|O2|Outcome|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), or 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
354449|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr. 8 cm long, (C-UDLM-501J-ABRM-HC), or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
354450|NCT00370149|E2|Reported Event|Conventional Non-impregnated Catheters (C/S)|Randomization to 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if there was a therapeutic difference between the M/R and C/S catheters. Patients randomized to this arm had the C/S inserted intra-operatively. Patients receiving this catheter were enrolled in the study.The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), 5 Fr., 12 cm long, (C-UDLM-501J-RSC). Patients were followed for adverse device affects and adverse events through their hospitalization stay
354495|NCT00370552|B1|Baseline|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354451|NCT00370149|E1|Reported Event|Antibiotic Impregnated Catheters (M/R)|Randomization to the 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if a therapeutic difference existed between M/R and C/S catheters. Patients randomized to this Arm had the M/R catheter inserted intra-operatively. Patients receiving this Catheter were enrolled in the study. The specific CVCs are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC). Patients were followed for adverse device affects and adverse events through their hospitalization stay.
354452|NCT00370292|B3|Baseline|Total|Total of all reporting groups
354453|NCT00370292|B2|Baseline|Pemetrexed - After Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
354454|NCT00370292|B1|Baseline|Pemetrexed - Before Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
354648|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354455|NCT00370292|P1|Participant Flow|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
354456|NCT00370292|O3|Outcome|hENT - Cycle 3|Mean hENT expression evaluated at Cycle 3.
354457|NCT00370292|O2|Outcome|hENT - Cycle 2|Mean hENT expression evaluated at Cycle 2.
354458|NCT00370292|O1|Outcome|hENT - Cycle 1|Mean hENT expression evaluated at Cycle 1.
354459|NCT00370292|O2|Outcome|Pemetrexed - After Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
354460|NCT00370292|O1|Outcome|Pemetrexed - Before Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
354461|NCT00370292|O3|Outcome|dCK - Cycle 3|Mean dCK expression evaluated at Cycle 3.
354462|NCT00370292|O2|Outcome|dCK - Cycle 2|Mean dCK expression evaluated at Cycle 2.
354463|NCT00370292|O1|Outcome|dCK - Cycle 1|Mean dCK expression evaluated at Cycle 1.
354464|NCT00370292|E1|Reported Event|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
354465|NCT00370331|B3|Baseline|Total|Total of all reporting groups
354466|NCT00370331|B2|Baseline|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354467|NCT00370331|B1|Baseline|Placebo|Matching placebo tablets taken once a day
354468|NCT00370331|P2|Participant Flow|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354469|NCT00370331|P1|Participant Flow|Placebo|Matching placebo tablets taken once a day
354470|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354471|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
354472|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354473|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
354474|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354475|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
354476|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354477|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
354478|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354479|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
354480|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354481|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
354482|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354483|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
354484|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354485|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
354486|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354487|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
354488|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354489|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
354490|NCT00370331|E2|Reported Event|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
354491|NCT00370331|E1|Reported Event|Placebo|Matching placebo tablets taken once a day
354492|NCT00370552|B4|Baseline|Total|Total of all reporting groups
354493|NCT00370552|B3|Baseline|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354494|NCT00370552|B2|Baseline|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354633|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354634|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354496|NCT00370552|P3|Participant Flow|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354497|NCT00370552|P2|Participant Flow|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
356570|NCT00368641|P2|Participant Flow|Standard Therapy|Standard therapy for CHF
354498|NCT00370552|P1|Participant Flow|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354499|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354500|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354501|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354502|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354503|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354504|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354505|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354506|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354507|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354557|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354635|NCT00371150|O3|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354508|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354509|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
356759|NCT00369226|B1|Baseline|Phase I|
354510|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354511|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354512|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354513|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354514|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354515|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354516|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354517|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354518|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354519|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354520|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354521|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354563|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354649|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354522|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354523|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354524|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354525|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354526|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354527|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354528|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354529|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354530|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354531|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354532|NCT00370552|E3|Reported Event|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354558|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354559|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354533|NCT00370552|E2|Reported Event|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity. After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone, as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354534|NCT00370552|E1|Reported Event|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone, as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
354535|NCT00370682|B4|Baseline|Total|Total of all reporting groups
354536|NCT00370682|B3|Baseline|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354537|NCT00370682|B2|Baseline|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354538|NCT00370682|B1|Baseline|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354539|NCT00370682|P3|Participant Flow|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354540|NCT00370682|P2|Participant Flow|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354541|NCT00370682|P1|Participant Flow|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354542|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354543|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354544|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354545|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354546|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354547|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354548|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354549|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354550|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354551|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354552|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354553|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354554|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354555|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354556|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354560|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354561|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354564|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354565|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354566|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354567|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354568|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354569|NCT00370682|O4|Outcome|PII (M9)|Post dose 2, Month 9
354570|NCT00370682|O3|Outcome|PII (M7)|Post dose 2, Month 7
354571|NCT00370682|O2|Outcome|PI (M1)|Post dose1 , Month 1
354572|NCT00370682|O1|Outcome|PRE Dose|Pre-dose 1
354573|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354574|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354575|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354576|NCT00370682|E3|Reported Event|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354577|NCT00370682|E2|Reported Event|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354578|NCT00370682|E1|Reported Event|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
354579|NCT00370838|B3|Baseline|Total|Total of all reporting groups
354580|NCT00370838|B2|Baseline|Clonidine First, Then Levetiracetam|"Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).
In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).
Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.
Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
354581|NCT00370838|B1|Baseline|Levetiracetam First, Then Clonidine|"Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).
In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).
Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.
Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
354582|NCT00370838|P2|Participant Flow|Clonidine First, Then Levetiracetam|"Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).
In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).
Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.
Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
354583|NCT00370838|P1|Participant Flow|First Levetiracetam Then Clonidine|"Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).
In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).
Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.
Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
354640|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354641|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354584|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354585|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354586|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354587|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354588|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354589|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354590|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354591|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354592|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354593|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354594|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354595|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354631|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354632|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354596|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354642|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354643|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354644|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354597|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354598|NCT00370838|E2|Reported Event|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354599|NCT00370838|E1|Reported Event|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
354600|NCT00370994|B3|Baseline|Total|Total of all reporting groups
354601|NCT00370994|B2|Baseline|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
354602|NCT00370994|B1|Baseline|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
354603|NCT00370994|P2|Participant Flow|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
354604|NCT00370994|P1|Participant Flow|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution.
354605|NCT00370994|O2|Outcome|Intervention Group|adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
354606|NCT00370994|O1|Outcome|Control Group|caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.
354607|NCT00370994|O2|Outcome|Intervention Group|adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
354608|NCT00370994|O1|Outcome|Control Group|caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.
354609|NCT00370994|E2|Reported Event|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
354610|NCT00370994|E1|Reported Event|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
354611|NCT00371137|B4|Baseline|Total|Total of all reporting groups
354612|NCT00371137|B3|Baseline|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
354613|NCT00371137|B2|Baseline|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
354614|NCT00371137|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
354615|NCT00371137|P3|Participant Flow|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
354616|NCT00371137|P2|Participant Flow|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
354617|NCT00371137|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
354618|NCT00371137|O3|Outcome|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
354619|NCT00371137|O2|Outcome|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
354620|NCT00371137|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
354621|NCT00371137|E3|Reported Event|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
354622|NCT00371137|E2|Reported Event|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
354623|NCT00371137|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
354624|NCT00371150|B3|Baseline|Total|Total of all reporting groups
354625|NCT00371150|B2|Baseline|Hispanic|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354626|NCT00371150|B1|Baseline|Black/ African American|Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354627|NCT00371150|P2|Participant Flow|Hispanic|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354628|NCT00371150|P1|Participant Flow|Black/ African American|Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354629|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354630|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354636|NCT00371150|O2|Outcome|Hispanic|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354637|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354638|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354639|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
356760|NCT00369226|P2|Participant Flow|Phase II (45 Days)|
354650|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354651|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354652|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354653|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354654|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354655|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354656|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
354657|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
354658|NCT00371150|E1|Reported Event|Entecavir (ETV)|Entecavir tablets, Oral, 0.5 mg, once daily, up to 48 weeks (Includes 6 participants of the Hispanic cohort)
354659|NCT00371176|B3|Baseline|Total|Total of all reporting groups
354660|NCT00371176|B2|Baseline|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354661|NCT00371176|B1|Baseline|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354662|NCT00371176|P2|Participant Flow|Placebo Plus Exposure|Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a placebo pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
354663|NCT00371176|P1|Participant Flow|D-Cycloserine Plus Exposure|Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a 50 mg DCS pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
354664|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354665|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354666|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354667|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354668|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354669|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354670|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354671|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354672|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354673|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354674|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354675|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354676|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354677|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354678|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354679|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354680|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354681|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354682|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354683|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354684|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354685|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354686|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354687|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354688|NCT00371176|E2|Reported Event|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
354689|NCT00371176|E1|Reported Event|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
354690|NCT00371254|B3|Baseline|Total|Total of all reporting groups
354691|NCT00371254|B2|Baseline|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354692|NCT00371254|B1|Baseline|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354693|NCT00371254|P2|Participant Flow|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354770|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354694|NCT00371254|P1|Participant Flow|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354695|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354696|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354697|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354698|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354699|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354700|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354701|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354702|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354703|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354704|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354705|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354706|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354707|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354708|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354709|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354710|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354711|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354712|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354713|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354714|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354715|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354716|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354717|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354718|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354719|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354720|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354721|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354722|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354723|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354724|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354725|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354726|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354727|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354728|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354729|NCT00371254|O3|Outcome|Dasatinib 50 mg BID|Participants were administered an oral dose of 50 mg dasatinib tablet twice daily for a total daily dose (TDD) of 100 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354730|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354731|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354732|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354733|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354734|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354735|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354736|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354737|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354738|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354739|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354740|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354771|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
354797|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
354741|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354742|NCT00371254|E1|Reported Event|All Participants|All treated participants who were administered a twice-daily oral dose of either 100 mg (TDD 200 mg) or 70 mg (TDD 140 mg) dasatinib tablet. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
354743|NCT00371267|B3|Baseline|Total|Total of all reporting groups
354744|NCT00371267|B2|Baseline|Arm 2|"Telephone-delivered patient education regarding management of chronic pain
Pain Education: Telephone-delivered education regarding chronic pain"
354745|NCT00371267|B1|Baseline|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management
Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
354746|NCT00371267|P2|Participant Flow|Arm 2|"Telephone-delivered patient education regarding management of chronic pain
Pain Education: Telephone-delivered education regarding chronic pain"
354747|NCT00371267|P1|Participant Flow|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management
Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
354748|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain
Pain Education: Telephone-delivered education regarding chronic pain"
354749|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management
Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
354750|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain
Pain Education: Telephone-delivered education regarding chronic pain"
354751|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management
Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
354752|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain
Pain Education: Telephone-delivered education regarding chronic pain"
354753|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management
Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
354754|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain
Pain Education: Telephone-delivered education regarding chronic pain"
354755|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management
Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
354756|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain
Pain Education: Telephone-delivered education regarding chronic pain"
354757|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management
Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
354758|NCT00371267|E2|Reported Event|Arm 2|"Telephone-delivered patient education regarding management of chronic pain
Pain Education: Telephone-delivered education regarding chronic pain"
354759|NCT00371267|E1|Reported Event|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management
Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
354760|NCT00371293|B4|Baseline|Total|Total of all reporting groups
354761|NCT00371293|B3|Baseline|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354762|NCT00371293|B2|Baseline|Weight Loss|"Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
354763|NCT00371293|B1|Baseline|CPAP|"Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354764|NCT00371293|P3|Participant Flow|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354765|NCT00371293|P2|Participant Flow|Weight Loss|"Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
354766|NCT00371293|P1|Participant Flow|CPAP|"Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
355504|NCT00364858|E3|Reported Event|Total|
354767|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354768|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
354769|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
357214|NCT00376363|B3|Baseline|Total|Total of all reporting groups
354772|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354773|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354774|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
354775|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354776|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354777|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will receive take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
354778|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354779|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354780|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
354781|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354782|NCT00371293|E3|Reported Event|Weight Loss|"Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
354783|NCT00371293|E2|Reported Event|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354784|NCT00371293|E1|Reported Event|CPAP|"Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
354785|NCT00371345|B3|Baseline|Total|Total of all reporting groups
354786|NCT00371345|B2|Baseline|ER and/or PgR Positive Tumor Type|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354787|NCT00371345|B1|Baseline|Her2/Neu-amplified Tumor Type|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354788|NCT00371345|P2|Participant Flow|ER and/or PgR Positive Tumor Type|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354789|NCT00371345|P1|Participant Flow|Her2/Neu-amplified Tumor Type|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354790|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
354791|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
355025|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID) plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
354792|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354793|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354794|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354795|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354796|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
354798|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
354799|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
354800|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
354801|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
354802|NCT00371345|O3|Outcome|Dasatinib 50 mg|Dasatinib was administered orally at a starting dose of 70 mg BID. Dose adjustment was made according to tolerance, with reduction to 50 mg BID. Participants continued study treatment until PD or unacceptable toxicity. Dasatinib dose was adjusted so that drug-related toxicities were either Grade 0 - 1 or were Grade 2 toxicities that were adequately managed with outpatient therapy or deemed clinically acceptable.
354803|NCT00371345|O2|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
354804|NCT00371345|O1|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
354805|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
354806|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
354807|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
354808|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
354809|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
354810|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
354811|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
354812|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
354813|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
354814|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
354815|NCT00371345|O3|Outcome|Participant CA180088-29-88085, ER and/or PgR Group|Participant with ER and PgR–amplified tumor type who received 70 mg dasatinib BID
354816|NCT00371345|O2|Outcome|Participant CA180088-16-88002, ER and/or PgR Group|Participant with ER and PgR–amplified tumor type who received 100 mg dasatinib BID
354817|NCT00371345|O1|Outcome|Participant CA180088-18-88009, HER-2 Group|Participant with Human epidermal growth factor (Her2/neu)–amplified tumor type (also positive for ER and PgR) who received 100 mg dasatinib BID.
354818|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354819|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354820|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354821|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354822|NCT00371345|O2|Outcome|ER and/or PgR Positive Tumor|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally dasatinib twice daily (BID).
354823|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally dasatinib twice daily (BID).
354824|NCT00371345|O3|Outcome|All Participants|Dasatinib was administered orally at 70 mg BID (TDD=140 mg) or 100 mg BID (TDD=200 mg).
355505|NCT00364858|E2|Reported Event|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
354825|NCT00371345|O2|Outcome|ER and/or PgR Positive Tumor|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally dasatinib twice daily (BID).
354826|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally dasatinib twice daily (BID).
354827|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354828|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354829|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
356571|NCT00368641|P1|Participant Flow|Intervention Group|Addition of peritoneal ultrafiltration
354830|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354831|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354832|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354833|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354834|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354835|NCT00371345|O5|Outcome|All Response-evaluable Participants|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).
354836|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354837|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354838|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354839|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354840|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354841|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354842|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
354843|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
354844|NCT00371345|E1|Reported Event|Dasatinib|Dasatinib was administered orally at 70 mg BID (TDD=140 mg) or 100 mg BID (TDD=200 mg).
354845|NCT00371397|B1|Baseline|Overall Study|Women were exposed to each of the conditions (yoga, movement control, and passive-video control) during three separate visits. The order of the visits was randomized per participant. 52 total participants enrolled.
354846|NCT00371397|P12|Participant Flow|Novice: Video Then Hatha Yoga Then Movement Control|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning."
354847|NCT00371397|P11|Participant Flow|Novice: Hatha Yoga Then Movement Control Then Video|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.
For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity."
354858|NCT00371397|O2|Outcome|Expert|Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
356572|NCT00368641|O2|Outcome|Standard Therapy|Standard therapy for CHF
354848|NCT00371397|P10|Participant Flow|Novice: Movement Control Then Video Then Hatha Yoga|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
354849|NCT00371397|P9|Participant Flow|Novice: Video Then Movement Control Then Hatha Yoga|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
354850|NCT00371397|P8|Participant Flow|Novice: Hatha Yoga Then Video Then Movement Control|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning."
354851|NCT00371397|P7|Participant Flow|Novice: Movement Control Then Hatha Yoga Then Video|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
354852|NCT00371397|P6|Participant Flow|Expert: Video Then Hatha Yoga Then Movement Control|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning."
354853|NCT00371397|P5|Participant Flow|Expert: Hatha Yoga Then Movement Control Then Video|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
354854|NCT00371397|P4|Participant Flow|Expert: Movement Control Then Video Then Hatha Yoga|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
354855|NCT00371397|P3|Participant Flow|Expert: Video Then Movement Control Then Hatha Yoga|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 3, participants completed the Hatha Yoga Class in 1 day and a 30 minute follow-up session the next morning."
354886|NCT00371462|O1|Outcome|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
354887|NCT00371462|E2|Reported Event|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
354856|NCT00371397|P2|Participant Flow|Expert: Hatha Yoga Then Video Then Movement Control|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
For Session 1, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning."
354857|NCT00371397|P1|Participant Flow|Expert: Movement Control Then Hatha Yoga Then Video|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 2, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
354859|NCT00371397|O1|Outcome|Novice|Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
354860|NCT00371397|E2|Reported Event|Expert|Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
354861|NCT00371397|E1|Reported Event|Novice|Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
354862|NCT00371436|B3|Baseline|Total|Total of all reporting groups
354863|NCT00371436|B2|Baseline|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
354864|NCT00371436|B1|Baseline|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
354865|NCT00371436|P2|Participant Flow|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
354866|NCT00371436|P1|Participant Flow|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
354867|NCT00371436|O2|Outcome|Arm 2|"Usual Care
Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic."
354868|NCT00371436|O1|Outcome|Arm 1|"Tinnitus Progressive Management
Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
354869|NCT00371436|E2|Reported Event|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
354870|NCT00371436|E1|Reported Event|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
354871|NCT00371449|B1|Baseline|Hearing Aid Users|Hearing aid users
354872|NCT00371449|P1|Participant Flow|Hearing-Aid Users|Individuals who wore hearing aids for > 3 months and at their current setting for at least 1 month
354873|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
354874|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
354875|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
354876|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
354877|NCT00371449|O1|Outcome|Hearing-aid Users|hearing aid users
354878|NCT00371449|O1|Outcome|Group 1|hearing aid users
354879|NCT00371449|E1|Reported Event|Hearing-aid Users|
354880|NCT00371462|B3|Baseline|Total|Total of all reporting groups
354881|NCT00371462|B2|Baseline|Arm 2|"MOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment)
MOVE! level 2 group weight loss counseling: Participants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months."
354882|NCT00371462|B1|Baseline|Arm 1|"MOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care);
Use of PDA + support to reduce weight and pain: participants will attend the MOVE! group, record their food, activity, mood, pain, and weight daily via a PDA. Participants will be assigned a coach to help them set physical activity and calorie goals in order to produce a weight loss of .5%-1% per week on average over the course of 6 months. Participants will continue to log using the PDA during the 2nd 6-months for follow-up. They will also be asked to attend assessments at 3, 6, 9, and 12 months."
354883|NCT00371462|P2|Participant Flow|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
354884|NCT00371462|P1|Participant Flow|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
354885|NCT00371462|O2|Outcome|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
355531|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
354888|NCT00371462|E1|Reported Event|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
354889|NCT00371540|B3|Baseline|Total|Total of all reporting groups
354890|NCT00371540|B2|Baseline|II Home Visits|"Follow-up in clinic every 3 months, home visits monthly
Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly."
354891|NCT00371540|B1|Baseline|I Routine Care|Routine care in the clinic
354892|NCT00371540|P2|Participant Flow|II Home Visits|"Follow-up in clinic every 3 months, home visits monthly
Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly."
354893|NCT00371540|P1|Participant Flow|I Routine Care|Routine care in the clinic
354894|NCT00371540|O2|Outcome|II Home Visits|
354895|NCT00371540|O1|Outcome|I Rountine Care|
354896|NCT00371540|O2|Outcome|II Home Visits|
354897|NCT00371540|O1|Outcome|I Rountine Care|
354898|NCT00371540|O2|Outcome|II Home Visits|
354899|NCT00371540|O1|Outcome|I Rountine Care|
354900|NCT00371540|E2|Reported Event|II Home Visits|
354903|NCT00371566|B2|Baseline|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354904|NCT00371566|B1|Baseline|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354905|NCT00371566|P2|Participant Flow|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354906|NCT00371566|P1|Participant Flow|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the institutions standard of care)
354907|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354908|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354909|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354910|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354911|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354912|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354913|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354914|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354915|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354916|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354917|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354918|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354919|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354920|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354921|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
355532|NCT00364949|O1|Outcome|Control|Control
354922|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354923|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354924|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354925|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354926|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354927|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
356573|NCT00368641|O1|Outcome|Intervention Group|Addition of peritoneal ultrafiltration
354928|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354929|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354930|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354931|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354932|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354933|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354934|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354935|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354936|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354937|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354938|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354939|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354940|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354941|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354942|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354943|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354944|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354945|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354946|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
355021|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355533|NCT00364949|E2|Reported Event|PCOS|Polycystic Ovary Syndrome
354947|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354948|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354949|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354950|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354951|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354952|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354953|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354954|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354955|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354956|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354957|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354958|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354959|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354960|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354961|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354962|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354963|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354964|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354965|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354966|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354967|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354968|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354969|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354970|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354971|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
355022|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
354972|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354973|NCT00371566|E2|Reported Event|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of mor than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
354974|NCT00371566|E1|Reported Event|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
354975|NCT00371631|B1|Baseline|Treatment Arm|"insertion of E. coli coated catheter
Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
354976|NCT00371631|P1|Participant Flow|Treatment Arm|"insertion of E. coli coated catheter
Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
354977|NCT00371631|O1|Outcome|Treatment Arm|"insertion of E. coli coated catheter
Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
354978|NCT00371631|O1|Outcome|Treatment Arm|"insertion of E. coli coated catheter
Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
354979|NCT00371631|E1|Reported Event|Treatment Arm|"insertion of E. coli coated catheter
Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
354980|NCT00371644|B3|Baseline|Total|Total of all reporting groups
354981|NCT00371644|B2|Baseline|Arm 2|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).
Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
354982|NCT00371644|B1|Baseline|Arm 1|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).
Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
354983|NCT00371644|P2|Participant Flow|Present Centered Therapy (PCT)|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).
Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
354984|NCT00371644|P1|Participant Flow|Cognitive Processing Therapy (CPT)|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).
Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
354985|NCT00371644|O2|Outcome|Present Centered Therapy (PCT)|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).
Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
354986|NCT00371644|O1|Outcome|Cognitive Processing Therapy (CPT)|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).
Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
354987|NCT00371644|E2|Reported Event|Arm 2|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).
Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
355023|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355024|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
354988|NCT00371644|E1|Reported Event|Arm 1|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).
Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
354989|NCT00371683|B3|Baseline|Total|Total of all reporting groups
354990|NCT00371683|B2|Baseline|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
354991|NCT00371683|B1|Baseline|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
355036|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ±2 days.
354992|NCT00371683|P2|Participant Flow|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug(day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
354993|NCT00371683|P1|Participant Flow|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug (day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
354994|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ±2 days.
354995|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
354996|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
354997|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days,± 2 days.
354998|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
354999|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID) plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355000|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
355001|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days,± 2 days.
355002|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
355003|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
355004|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, plus or minus 2 days.
355005|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
355006|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, plus or minus 2 days.
355007|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
355008|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
355009|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
355010|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
355011|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355012|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ±2 days.
355013|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355014|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
355015|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355016|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
355017|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355018|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
355019|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355020|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
355534|NCT00364949|E1|Reported Event|Control|Control
355026|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days,± 2 days.
355027|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355028|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
355029|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355030|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
355031|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355032|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ±2 days.
355033|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355034|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
355035|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355037|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355038|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus placebo tablets BID for 12 days, ± 2 days.
355039|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
355040|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
355041|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, ± 2 days.
355042|NCT00371683|E2|Reported Event|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
355043|NCT00371683|E1|Reported Event|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
355044|NCT00371761|B3|Baseline|Total|Total of all reporting groups
355045|NCT00371761|B2|Baseline|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
355046|NCT00371761|B1|Baseline|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
355047|NCT00371761|P2|Participant Flow|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
355048|NCT00371761|P1|Participant Flow|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
355049|NCT00371761|O2|Outcome|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
355050|NCT00371761|O1|Outcome|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
355051|NCT00371761|E2|Reported Event|Adefovir|
355052|NCT00371761|E1|Reported Event|PegIntron|
355053|NCT00371787|B3|Baseline|Total|Total of all reporting groups
355054|NCT00371787|B2|Baseline|Control Group|normal non-lens wearers
355055|NCT00371787|B1|Baseline|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
355056|NCT00371787|P2|Participant Flow|Control Group|normal non-lens wearers
355057|NCT00371787|P1|Participant Flow|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
355058|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
355059|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
355060|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
355061|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
355062|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
355063|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
355064|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
355065|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
355066|NCT00371787|E2|Reported Event|Control Group|normal non-lens wearers
355067|NCT00371787|E1|Reported Event|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
355068|NCT00371826|B4|Baseline|Total|Total of all reporting groups
355197|NCT00371839|B2|Baseline|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)
Study performance on cognitive and hearing tests
Audiological Evaluation: Tests of hearing, cognition, and speech perception"
355198|NCT00371839|B1|Baseline|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)
Study performance on cognitive and hearing tests
Audiological Evaluation: Tests of hearing, cognition, and speech perception"
355199|NCT00371839|P3|Participant Flow|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)
Study performance on cognitive and hearing tests
Audiological Evaluation: Tests of hearing, cognition, and speech perception"
355506|NCT00364858|E1|Reported Event|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
356517|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
355069|NCT00371826|B3|Baseline|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355070|NCT00371826|B2|Baseline|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355219|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
355220|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
355071|NCT00371826|B1|Baseline|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355072|NCT00371826|P3|Participant Flow|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355073|NCT00371826|P2|Participant Flow|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355074|NCT00371826|P1|Participant Flow|Calcineurin Inhibitor (CNI) Withdrawal|Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day
355075|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355076|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355077|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355200|NCT00371839|P2|Participant Flow|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)
Study performance on cognitive and hearing tests
Audiological Evaluation: Tests of hearing, cognition, and speech perception"
355507|NCT00364923|B1|Baseline|Full Population|All patients who received at least one dose of pralatrexate
355078|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355079|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355080|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355081|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355082|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355083|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355084|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355085|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355086|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355201|NCT00371839|P1|Participant Flow|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)
Study performance on cognitive and hearing tests
Audiological Evaluation: Tests of hearing, cognition, and speech perception"
356518|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
355087|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355088|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355089|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355090|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355091|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355092|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355093|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355094|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355095|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355202|NCT00371839|O3|Outcome|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)
Study performance on cognitive and hearing tests
Audiological Evaluation: Tests of hearing, cognition, and speech perception"
356519|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
355096|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355097|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355098|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355099|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355100|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355101|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355102|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355103|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355104|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355203|NCT00371839|O2|Outcome|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)
Study performance on cognitive and hearing tests
Audiological Evaluation: Tests of hearing, cognition, and speech perception"
355779|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
355105|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355106|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355107|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355108|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355109|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355110|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355111|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355112|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355113|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355204|NCT00371839|O1|Outcome|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)
Study performance on cognitive and hearing tests
Audiological Evaluation: Tests of hearing, cognition, and speech perception"
355780|NCT00365599|E1|Reported Event|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
355114|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355115|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355116|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355117|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355118|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355119|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355120|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355121|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355122|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355205|NCT00371839|E1|Reported Event|Arm 1|"Study performance on cognitive and hearing tests
Audiological Evaluation: Tests of hearing, cognition, and speech perception"
355206|NCT00371865|B3|Baseline|Total|Total of all reporting groups
355781|NCT00372385|B5|Baseline|Total|Total of all reporting groups
355123|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355124|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355125|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355126|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355127|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355128|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355129|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355130|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355131|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355207|NCT00371865|B2|Baseline|Acceptance-Based Therapy|"8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
356520|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
355132|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355133|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355134|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355135|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355136|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355137|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355138|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355139|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355140|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355208|NCT00371865|B1|Baseline|Cognitive Behavioral Therapy|"8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
356521|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
355141|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355142|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355143|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355144|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355145|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355146|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355147|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355148|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355149|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355209|NCT00371865|P2|Participant Flow|Acceptance-Based Therapy|"8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
356522|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
355150|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355151|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355152|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355153|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355154|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355155|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355156|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355157|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355158|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355210|NCT00371865|P1|Participant Flow|Cognitive Behavioral Therapy|"8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
356523|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
355159|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355160|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355161|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355162|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355163|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355164|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355165|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355166|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355167|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355211|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
356524|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
355168|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355169|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355170|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355171|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355172|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355173|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355174|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355175|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355176|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355212|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
356525|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
355177|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355178|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355179|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355180|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355181|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355182|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355183|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355184|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355185|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355213|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
356526|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
355186|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355187|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355188|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355189|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355190|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355191|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355192|NCT00371826|E3|Reported Event|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
355193|NCT00371826|E2|Reported Event|CNI+MPA+ Steroid|"Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
355194|NCT00371826|E1|Reported Event|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
355195|NCT00371839|B4|Baseline|Total|Total of all reporting groups
355196|NCT00371839|B3|Baseline|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)
Study performance on cognitive and hearing tests
Audiological Evaluation: Tests of hearing, cognition, and speech perception"
355214|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
355215|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
355216|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
355217|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
355218|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
361073|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
355221|NCT00371865|E2|Reported Event|Arm 2|"8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
355222|NCT00371865|E1|Reported Event|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
355223|NCT00372060|B3|Baseline|Total|Total of all reporting groups
355224|NCT00372060|B2|Baseline|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
355225|NCT00372060|B1|Baseline|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
355226|NCT00372060|P2|Participant Flow|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
355227|NCT00372060|P1|Participant Flow|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
355228|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily and who received at least one dose of sitagliptin and were in the CP. This column of data reflects the change from Week 12 at Week 52.
355229|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) orally once daily who were in the CP. This column of data reflects the change from Week 0 at Week 52.
355230|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
355231|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
355414|NCT00364832|P11|Participant Flow|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered SC RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355232|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
355233|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
355416|NCT00364832|P9|Participant Flow|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355754|NCT00365456|E2|Reported Event|Risedronate|Trial Period II SAEs and Trial Period III SAEs for subjects receiving risedronate
355234|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
355235|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
355236|NCT00372060|E3|Reported Event|Pooled Sitagliptin (Data Through Week 52)|The Pooled Sitagliptin group includes data from all patients who took sitagliptin in either treatment group. Includes data from Week 0 to Week 52 for patients in the Sitagliptin/Sitagliptin group and data from Week 12 to Week 52 for patients in the Placebo/Sitagliptin group. Includes patients (from either group) who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
355237|NCT00372060|E2|Reported Event|Placebo/Sitagliptin (Data Through Week 12)|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily. This column of data includes only Weeks 0-12.
355238|NCT00372060|E1|Reported Event|Sitagliptin/Sitagliptin (Data Through Week 12)|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin orally once daily (Weeks 0-52). This column of data includes only Weeks 0-12.
355239|NCT00372190|B3|Baseline|Total|Total of all reporting groups
355240|NCT00372190|B2|Baseline|Conventional|"Classical vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
355241|NCT00372190|B1|Baseline|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)
Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
355242|NCT00372190|P2|Participant Flow|Conventional|"Classical vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
99 randomized to conventional surgery, 1 refused surgery for comorbidity, 1 died prior to surgery; 97 underwent conventional surgery"
355243|NCT00372190|P1|Participant Flow|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)
Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit.
95 randomized for mesh, 2 refused surgery; 93 underwent mesh insertion"
355244|NCT00372190|O2|Outcome|Conventional|"Classical vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
355245|NCT00372190|O1|Outcome|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)
Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
355246|NCT00372190|O2|Outcome|Conventional|"Classical vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
355247|NCT00372190|O1|Outcome|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)
Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
355248|NCT00372190|O2|Outcome|Conventional|"Classical vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
355249|NCT00372190|O1|Outcome|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)
Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
355250|NCT00372190|O2|Outcome|Conventional|"Classical vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
99 randomized to conventional surgery, 1 refused surgery for comorbidity, 1 died prior to surgery; 97 underwent conventional surgery"
355251|NCT00372190|O1|Outcome|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)
Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit.
95 randomized for mesh, 2 refused surgery; 93 underwent mesh insertion"
355252|NCT00372190|E2|Reported Event|Conventional|"Classical vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
355253|NCT00372190|E1|Reported Event|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)
Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
355254|NCT00364793|B5|Baseline|Total|Total of all reporting groups
356527|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
355255|NCT00364793|B4|Baseline|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355417|NCT00364832|P8|Participant Flow|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355755|NCT00365456|E1|Reported Event|PTH (1-84)|Trial Period I SAEs and Trial Period III SAEs for subjects receiving PTH (1-84)
355256|NCT00364793|B3|Baseline|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355257|NCT00364793|B2|Baseline|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355258|NCT00364793|B1|Baseline|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355259|NCT00364793|P4|Participant Flow|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355260|NCT00364793|P3|Participant Flow|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355261|NCT00364793|P2|Participant Flow|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355262|NCT00364793|P1|Participant Flow|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and emtricitabine (FTC) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355263|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355264|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355508|NCT00364923|P1|Participant Flow|Full Population|All patients who received at least one dose of pralatrexate. Patients continued pralatrexate until protocol defined criteria for discontinuation or 24 months of treatment.
355265|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355266|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355267|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355268|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355269|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355270|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355271|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355272|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355273|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355274|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355275|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
356528|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
355276|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355277|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355278|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355279|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355280|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355281|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355282|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355283|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355284|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355285|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355286|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
356529|NCT00368459|E2|Reported Event|Placebo|identical appearing oral placebo
355287|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355288|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355289|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355290|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355291|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355292|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355293|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355294|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355295|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355431|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355315|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355296|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355297|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355298|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355299|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355300|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355301|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355302|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355303|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355304|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355509|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
355305|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355306|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355307|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355308|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355309|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355310|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355311|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355312|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355313|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355314|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355510|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
357489|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
355316|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355317|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355318|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355319|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355320|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355321|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355322|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355323|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355324|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355325|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
356530|NCT00368459|E1|Reported Event|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
355326|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355327|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355328|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355329|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355330|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355331|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355332|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355333|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355334|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355335|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355336|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
357287|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
355337|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355338|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355339|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355340|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355341|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355342|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355343|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355344|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355345|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355346|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355347|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355511|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
355348|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355349|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355350|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355351|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355352|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355353|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355354|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355355|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355356|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355357|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355358|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355512|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
355359|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355360|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355361|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355362|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355363|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355364|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355365|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355366|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355367|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355368|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355369|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
357288|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
355381|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355370|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355371|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355372|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355373|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355374|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355375|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355376|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355377|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355378|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355379|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355380|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355382|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355383|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355384|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355385|NCT00364793|O5|Outcome|Total Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
355386|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355387|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355388|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355389|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355390|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355391|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355392|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355513|NCT00364923|E1|Reported Event|Full Population|All patients who received at least one dose of pralatrexate
355393|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355394|NCT00364793|E1|Reported Event|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
355395|NCT00364819|B1|Baseline|Open Label Study Arm|"Primary Biliary Cirrhosis
rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
355396|NCT00364819|P1|Participant Flow|Open Label Study Arm|"Primary Biliary Cirrhosis
rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
355397|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis
rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
355398|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis
rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
355399|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis
rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
355400|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis
rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
355401|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis
rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
355402|NCT00364819|E1|Reported Event|Open Label Study Arm|"Primary Biliary Cirrhosis
rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
355403|NCT00364832|B10|Baseline|Total|Total of all reporting groups
355404|NCT00364832|B9|Baseline|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355405|NCT00364832|B8|Baseline|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355406|NCT00364832|B7|Baseline|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355407|NCT00364832|B6|Baseline|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355408|NCT00364832|B5|Baseline|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355409|NCT00364832|B4|Baseline|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355410|NCT00364832|B3|Baseline|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355411|NCT00364832|B2|Baseline|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355412|NCT00364832|B1|Baseline|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355413|NCT00364832|P12|Participant Flow|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered SC RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355432|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355514|NCT00364949|B3|Baseline|Total|Total of all reporting groups
355415|NCT00364832|P10|Participant Flow|RO0503821 (1x/ Week)|Eligible participants were administered SC RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kilogram of the previous weekly ESA dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355756|NCT00365508|B3|Baseline|Total|Total of all reporting groups
355418|NCT00364832|P7|Participant Flow|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355419|NCT00364832|P6|Participant Flow|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355420|NCT00364832|P5|Participant Flow|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355421|NCT00364832|P4|Participant Flow|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355422|NCT00364832|P3|Participant Flow|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355423|NCT00364832|P2|Participant Flow|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355424|NCT00364832|P1|Participant Flow|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneous (SC) using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355425|NCT00364832|O3|Outcome|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355426|NCT00364832|O2|Outcome|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355427|NCT00364832|O1|Outcome|RO0503821 (1x/ Week)|Eligible participants were administered subcutaneous (SC) RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355428|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355429|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355430|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355497|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
355433|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355434|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355435|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355822|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
355436|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355437|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355438|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355439|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355440|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355441|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355442|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355443|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355444|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355445|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355446|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355447|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355448|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355449|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355450|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355498|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
355499|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
355451|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355452|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355453|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355454|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355455|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355456|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355457|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355458|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355459|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355460|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355461|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355462|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355463|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355464|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355465|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355466|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355467|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355468|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355500|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
355501|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
355469|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355470|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355471|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355472|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355473|NCT00364832|E3|Reported Event|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355474|NCT00364832|E2|Reported Event|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355475|NCT00364832|E1|Reported Event|RO0503821 (1x/ Week)|Eligible participants were administered subcutaneous (SC) RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
355476|NCT00364845|B3|Baseline|Total|Total of all reporting groups
355477|NCT00364845|B2|Baseline|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
355478|NCT00364845|B1|Baseline|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
355479|NCT00364845|P2|Participant Flow|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
355480|NCT00364845|P1|Participant Flow|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
355481|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
355482|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
355483|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
355484|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
355485|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
355486|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
355487|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
355488|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
355489|NCT00364845|E2|Reported Event|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
355490|NCT00364845|E1|Reported Event|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
355491|NCT00364858|B3|Baseline|Total|Total of all reporting groups
355492|NCT00364858|B2|Baseline|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
355493|NCT00364858|B1|Baseline|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
355494|NCT00364858|P2|Participant Flow|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
355495|NCT00364858|P1|Participant Flow|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
355496|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
355535|NCT00365053|B1|Baseline|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies"
355536|NCT00365053|P1|Participant Flow|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies"
355537|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies"
355538|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies"
355539|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies"
355540|NCT00365053|E1|Reported Event|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies"
355541|NCT00365105|B3|Baseline|Total|Total of all reporting groups
355542|NCT00365105|B2|Baseline|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
355543|NCT00365105|B1|Baseline|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
355544|NCT00365105|P2|Participant Flow|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
355545|NCT00365105|P1|Participant Flow|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
355546|NCT00365105|O2|Outcome|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
355547|NCT00365105|O1|Outcome|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
355548|NCT00365105|E2|Reported Event|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
355549|NCT00365105|E1|Reported Event|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
355550|NCT00365144|B1|Baseline|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
355551|NCT00365144|P1|Participant Flow|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
355552|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
355553|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
355554|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
355555|NCT00365144|E1|Reported Event|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
355556|NCT00365209|B1|Baseline|Curcumin|"Stage 1: Patients receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Patients receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355557|NCT00365209|P1|Participant Flow|Curcumin|"Stage 1: Particpants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Particpants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355558|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355559|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355560|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355561|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
359367|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
355562|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355563|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355630|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355564|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355565|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355566|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355567|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355568|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355569|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355570|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355571|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355572|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355573|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355574|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355575|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355576|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355650|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355577|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355578|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355579|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355580|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355581|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355582|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355583|NCT00365209|E2|Reported Event|Stage2 4 g Curcumin|"Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355584|NCT00365209|E1|Reported Event|Stage1 2 g Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
curcumin: Given orally"
355585|NCT00365261|B3|Baseline|Total|Total of all reporting groups
355586|NCT00365261|B2|Baseline|Placebo|receipt of placebo
355587|NCT00365261|B1|Baseline|Eszopiclone|receipt of active drug
355588|NCT00365261|P2|Participant Flow|Placebo|receipt of placebo
355589|NCT00365261|P1|Participant Flow|Eszopiclone|receipt of active drug
355590|NCT00365261|O2|Outcome|Placebo|placebo
355591|NCT00365261|O1|Outcome|Eszopiclone|active drug
355592|NCT00365261|O2|Outcome|Placebo|"placebo
Placebo: placebo 2 to 3 mg po at bedtime"
355593|NCT00365261|O1|Outcome|Eszopiclone|"active drug
Eszopiclone: eszopiclone 2 to 3 mg po at bedtime"
355594|NCT00365261|O2|Outcome|Placebo|placebo
355595|NCT00365261|O1|Outcome|Eszopiclone|active drug
355596|NCT00365261|E2|Reported Event|Placebo|receipt of placebo
355597|NCT00365261|E1|Reported Event|Eszopiclone|receipt of active drug
355598|NCT00365274|B1|Baseline|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.
SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
355599|NCT00365274|P1|Participant Flow|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.
SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
355600|NCT00365274|O1|Outcome|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.
SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
355601|NCT00365274|E1|Reported Event|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.
SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
355602|NCT00365300|B3|Baseline|Total|Total of all reporting groups
355603|NCT00365300|B2|Baseline|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
359368|NCT00382993|O1|Outcome|Placebo|
355604|NCT00365300|B1|Baseline|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
355605|NCT00365300|P2|Participant Flow|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
355606|NCT00365300|P1|Participant Flow|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
355607|NCT00365300|O2|Outcome|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
355608|NCT00365300|O1|Outcome|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
355609|NCT00365300|E5|Reported Event|Follow-up|
355610|NCT00365300|E4|Reported Event|Placebo (Double-blind Phase)|
355611|NCT00365300|E3|Reported Event|Pantoprazole Sodium Granules (Double-blind Phase)|
355612|NCT00365300|E2|Reported Event|Pantoprazole Sodium Granules (Open-Label Phase)|
355613|NCT00365300|E1|Reported Event|Screening|
355614|NCT00365352|B4|Baseline|Total|Total of all reporting groups
355615|NCT00365352|B3|Baseline|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355616|NCT00365352|B2|Baseline|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355617|NCT00365352|B1|Baseline|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355618|NCT00365352|P3|Participant Flow|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355619|NCT00365352|P2|Participant Flow|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355620|NCT00365352|P1|Participant Flow|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355621|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355622|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355623|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355624|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355625|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355626|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355627|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355747|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
356430|NCT00374803|P2|Participant Flow|Myfortic 720 mg Twice Daily|Myfortic 720 mg twice daily (1440 mg/day).
355628|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355629|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355752|NCT00365456|O2|Outcome|Risedronate|Regimen 2 = PTH (1-84) → Risedronate → Risedronate
355753|NCT00365456|O1|Outcome|PTH (1-84)|Regimen 1 = PTH (1-84) → Risedronate → PTH (1-84)
361074|NCT00386334|O1|Outcome|Placebo|Placebo tablets
355631|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355632|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355633|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355634|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355635|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355636|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355637|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355638|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355639|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355640|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355641|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355642|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355643|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355644|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355645|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355646|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355647|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355648|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355649|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355775|NCT00365599|B1|Baseline|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
359369|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
355651|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355652|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355653|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355654|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355655|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355656|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355657|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355658|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355659|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355660|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355661|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355662|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355663|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355664|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355665|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355666|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355667|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355668|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355669|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355670|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355671|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355672|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355776|NCT00365599|P1|Participant Flow|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
355777|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
355673|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355674|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355675|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355676|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355677|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355678|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355679|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355680|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355681|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355682|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355683|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355684|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg Taken Orally Once a Day|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355685|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 Milligrams(mg) Taken Orally|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355686|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355687|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355688|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355689|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355690|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355691|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355692|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355693|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355694|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355695|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355696|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
355697|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355698|NCT00365352|E3|Reported Event|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
361075|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
355699|NCT00365352|E2|Reported Event|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355700|NCT00365352|E1|Reported Event|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
355701|NCT00365365|B4|Baseline|Total|Total of all reporting groups
355702|NCT00365365|B3|Baseline|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered
docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by
bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355703|NCT00365365|B2|Baseline|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered
docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355704|NCT00365365|B1|Baseline|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered
doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by
docetaxel (T) + bevacizumab for 4 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355705|NCT00365365|P3|Participant Flow|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered
docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by
bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355706|NCT00365365|P2|Participant Flow|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered
docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355707|NCT00365365|P1|Participant Flow|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered
doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by
docetaxel (T) + bevacizumab for 4 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355708|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered
docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by
bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355709|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered
docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355710|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered
doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by
docetaxel (T) + bevacizumab for 4 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355711|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered
docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by
bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355712|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered
docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355713|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered
doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by
docetaxel (T) + bevacizumab for 4 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355714|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered
docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by
bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355715|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered
docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355716|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered
doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by
docetaxel (T) + bevacizumab for 4 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355717|NCT00365365|E3|Reported Event|TCH + Bevacizumab|"All HER2-positive participants administered
docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by
bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355718|NCT00365365|E2|Reported Event|TAC + Bevacizumab|"HER2-negative participants administered
docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
357289|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
355719|NCT00365365|E1|Reported Event|AC->T + Bevacizumab|"HER2-negative participants administered
doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by
docetaxel (T) + bevacizumab for 4 cycles followed by
bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
355720|NCT00365378|B3|Baseline|Total|Total of all reporting groups
355721|NCT00365378|B2|Baseline|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
355722|NCT00365378|B1|Baseline|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
355723|NCT00365378|P3|Participant Flow|Extension|This group includes 400 subjects who received Monovalent HPV 16 L1 VLP vaccine or placebo during the base study. This includes subjects who previously discontinued from the study.
355724|NCT00365378|P2|Participant Flow|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)"
355725|NCT00365378|P1|Participant Flow|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)"
355726|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
355727|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
355728|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
355729|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
355730|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
355731|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
355732|NCT00365378|E3|Reported Event|Extension|This group includes 400 subjects who received Monovalent HPV 16 L1 VLP vaccine or placebo during the base study. This includes subjects who previously discontinued from the study.
355733|NCT00365378|E2|Reported Event|Placebo (Group 2)|The number of subjects who actually received the vaccine material corresponding to the indicated vaccination group. There was one subject randomized to the HPV 16 L1 VLP vaccine group who received placebo and then discontinued study participation. There was 1 subject randomized to the placebo group who received one vaccination of HPV 16 L1 VLP vaccine and then discontinued study participation. These 2 subjects were included in the counts reported in the Adverse Event tables. There were 2 subjects randomized to the HPV 16 L1 VLP vaccine group and 2 subjects randomized to the placebo group and who received mixed vaccine material. These 4 subjects were not included in the counts reported in this table. Therefore, this table reports N=1191 (1193 minus 2) subjects vaccinated with HPV 16 L1 VLP vaccine and N=1196 (1198 minus 2) subjects vaccinated with placebo.
355734|NCT00365378|E1|Reported Event|HPV 16 L1 VLP (Group 1)|The number of subjects who actually received the vaccine material corresponding to the indicated vaccination group. There was one subject randomized to the HPV 16 L1 VLP vaccine group who received placebo and then discontinued study participation. There was 1 subject randomized to the placebo group who received one vaccination of HPV 16 L1 VLP vaccine and then discontinued study participation. These 2 subjects were included in the counts reported in the Adverse Event tables. There were 2 subjects randomized to the HPV 16 L1 VLP vaccine group and 2 subjects randomized to the placebo group and who received mixed vaccine material. These 4 subjects were not included in the counts reported in this table. Therefore, this table reports N=1191 (1193 minus 2) subjects vaccinated with HPV 16 L1 VLP vaccine and N=1196 (1198 minus 2) subjects vaccinated with placebo.
355778|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
355735|NCT00365391|B1|Baseline|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
355736|NCT00365391|P1|Participant Flow|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine epidermal growth factor receptor (EGFR) and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by immuno-histochemistry (IHC) for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, mitogen-activated protein kinase (MAPK), and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
355737|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
355738|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
355739|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
355740|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
355741|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
355742|NCT00365391|E1|Reported Event|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
355743|NCT00365417|B1|Baseline|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
355744|NCT00365417|P1|Participant Flow|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
355745|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
355746|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
357290|NCT00376675|E2|Reported Event|Placebo|Patients receive oral placebo daily on days 1-28.
355748|NCT00365417|E1|Reported Event|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
355749|NCT00365456|B1|Baseline|PTH(1-84) or Risedronate|"PTH(1-84) received by 405 participants in Trial Period I
of those 405 participants, 282 received Risedronate in Trial Period II
of those 282 participants, 268 participant remained and 136 received PTH(1-84) and 132 received Risedronate in Trial Period III"
355750|NCT00365456|P2|Participant Flow|Risedronate|
355751|NCT00365456|P1|Participant Flow|PTH (1-84)|
355757|NCT00365508|B2|Baseline|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
355758|NCT00365508|B1|Baseline|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
355759|NCT00365508|P2|Participant Flow|Nicotine Lozenge|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
355760|NCT00365508|P1|Participant Flow|Nicotine Patch|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
355761|NCT00365508|O2|Outcome|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
355762|NCT00365508|O1|Outcome|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
355763|NCT00365508|O2|Outcome|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
355764|NCT00365508|O1|Outcome|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
355765|NCT00365508|E2|Reported Event|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
355766|NCT00365508|E1|Reported Event|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
355767|NCT00365547|B1|Baseline|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
355768|NCT00365547|P1|Participant Flow|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
355769|NCT00365547|O1|Outcome|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
355770|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).
355771|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).
355772|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Only patients that remained in the study for at least 2 months and had the tumor measurements necessary to meet RECIST criteria are included.
355773|NCT00365547|O1|Outcome|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab) given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
355774|NCT00365547|E1|Reported Event|Safety Population|Patients who received treatment with weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
355782|NCT00372385|B4|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
355783|NCT00372385|B3|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
355784|NCT00372385|B2|Baseline|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
356024|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
355785|NCT00372385|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
355786|NCT00372385|P4|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
355787|NCT00372385|P3|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
355788|NCT00372385|P2|Participant Flow|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
355789|NCT00372385|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
355790|NCT00372385|O1|Outcome|Telaprevir|All Subjects from “Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week” and “Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week” reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks.
355791|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
355792|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
355793|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
355794|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
355795|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
355796|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
355797|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
355798|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
355799|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
356020|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
356021|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
355800|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
355801|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
356025|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
356026|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
355802|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
355803|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
355804|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
355805|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
355806|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
355807|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
355808|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
355809|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
355810|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
355811|NCT00372385|E4|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
355812|NCT00372385|E3|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
355813|NCT00372385|E2|Reported Event|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
355814|NCT00372385|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
355815|NCT00372411|B4|Baseline|Total|Total of all reporting groups
355816|NCT00372411|B3|Baseline|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
355817|NCT00372411|B2|Baseline|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
355818|NCT00372411|B1|Baseline|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
355819|NCT00372411|P3|Participant Flow|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
357430|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
355820|NCT00372411|P2|Participant Flow|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
355821|NCT00372411|P1|Participant Flow|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
355823|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
355824|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
355825|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
355826|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
355827|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
355828|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
355829|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
355830|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
355831|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
355832|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
355833|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
355834|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
355835|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
355836|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
355837|NCT00372411|E3|Reported Event|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
355838|NCT00372411|E2|Reported Event|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
355839|NCT00372411|E1|Reported Event|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
355840|NCT00372424|B1|Baseline|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
356022|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
356023|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
355841|NCT00372424|P1|Participant Flow|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
356027|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
356169|NCT00373490|B2|Baseline|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
355842|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
355843|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
355844|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
355845|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
355846|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
355847|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
355848|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
355849|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
355850|NCT00372424|E1|Reported Event|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
359370|NCT00382993|O1|Outcome|Placebo|
355851|NCT00372489|B1|Baseline|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
356028|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
355852|NCT00372489|P1|Participant Flow|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
355853|NCT00372489|O1|Outcome|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
355854|NCT00372489|E1|Reported Event|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
355855|NCT00372528|B1|Baseline|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
355856|NCT00372528|P1|Participant Flow|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
355857|NCT00372528|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
355858|NCT00372528|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
355859|NCT00372528|E1|Reported Event|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
355860|NCT00372593|B4|Baseline|Total|Total of all reporting groups
355861|NCT00372593|B3|Baseline|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355862|NCT00372593|B2|Baseline|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355863|NCT00372593|B1|Baseline|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355864|NCT00372593|P3|Participant Flow|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
356364|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356029|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
356030|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
356031|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
356574|NCT00368641|E2|Reported Event|Standard Therapy|Standard therapy for CHF
355865|NCT00372593|P2|Participant Flow|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355866|NCT00372593|P1|Participant Flow|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355867|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355868|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355869|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355870|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355871|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355950|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355872|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355873|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355874|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355875|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355876|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355877|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355878|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355935|NCT00372697|B2|Baseline|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355879|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355880|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355881|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355882|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355883|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355884|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355885|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355936|NCT00372697|B1|Baseline|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
359371|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
355886|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355887|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355888|NCT00372593|E3|Reported Event|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355889|NCT00372593|E2|Reported Event|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355890|NCT00372593|E1|Reported Event|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
355891|NCT00372619|B8|Baseline|Total|Total of all reporting groups
355892|NCT00372619|B7|Baseline|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355893|NCT00372619|B6|Baseline|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355937|NCT00372697|P2|Participant Flow|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355894|NCT00372619|B5|Baseline|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355895|NCT00372619|B4|Baseline|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355896|NCT00372619|B3|Baseline|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355897|NCT00372619|B2|Baseline|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355898|NCT00372619|B1|Baseline|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355899|NCT00372619|P7|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355900|NCT00372619|P6|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355901|NCT00372619|P5|Participant Flow|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
356365|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
355902|NCT00372619|P4|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355903|NCT00372619|P3|Participant Flow|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355904|NCT00372619|P2|Participant Flow|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355905|NCT00372619|P1|Participant Flow|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355906|NCT00372619|O7|Outcome|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355907|NCT00372619|O6|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355908|NCT00372619|O5|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355909|NCT00372619|O4|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
356366|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
355910|NCT00372619|O3|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355911|NCT00372619|O2|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355912|NCT00372619|O1|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355913|NCT00372619|O7|Outcome|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355914|NCT00372619|O6|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355915|NCT00372619|O5|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355916|NCT00372619|O4|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355917|NCT00372619|O3|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
356367|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
359372|NCT00382993|O1|Outcome|Placebo|
355918|NCT00372619|O2|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355919|NCT00372619|O1|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355920|NCT00372619|O7|Outcome|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355921|NCT00372619|O6|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355922|NCT00372619|O5|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355923|NCT00372619|O4|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355924|NCT00372619|O3|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355925|NCT00372619|O2|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
356368|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
359373|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
355926|NCT00372619|O1|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355927|NCT00372619|E7|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355928|NCT00372619|E6|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355929|NCT00372619|E5|Reported Event|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355930|NCT00372619|E4|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355931|NCT00372619|E3|Reported Event|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355932|NCT00372619|E2|Reported Event|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355933|NCT00372619|E1|Reported Event|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.
clofarabine: Given IV for 5 days
cytarabine: Given IV
methotrexate: Given intrathecally or IT age based dosage
laboratory biomarker analysis"
355934|NCT00372697|B3|Baseline|Total|Total of all reporting groups
359374|NCT00382993|O1|Outcome|Placebo|
355938|NCT00372697|P1|Participant Flow|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355939|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355940|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355941|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355942|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355943|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355944|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355945|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355946|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355947|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355948|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355949|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355951|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355952|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355953|NCT00372697|E2|Reported Event|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355954|NCT00372697|E1|Reported Event|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
355955|NCT00372775|B1|Baseline|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355956|NCT00372775|P1|Participant Flow|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355957|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355958|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355959|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355960|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355961|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355962|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355963|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355964|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355965|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355966|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355967|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355968|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355969|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355970|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355971|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355972|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355973|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355974|NCT00372775|E1|Reported Event|Sunitinib|Sunitinib 37.5 mg oral capsule daily
355975|NCT00372970|B3|Baseline|Total|Total of all reporting groups
355976|NCT00372970|B2|Baseline|Placebo|Received 5 cc saline injected into pyloric sphincter endoscopically.
355977|NCT00372970|B1|Baseline|Botulinum Toxin|Received 200U of Botox injected into pyloric sphincter endoscopically.
355978|NCT00372970|P2|Participant Flow|Placebo|Received 5 cc saline injected into pyloric sphincter endoscopically.
355979|NCT00372970|P1|Participant Flow|Botulinum Toxin|Received 200U of Botox injected into pyloric sphincter endoscopically.
355980|NCT00372970|O2|Outcome|Placebo|saline Injection into pylorus
355981|NCT00372970|O1|Outcome|Botox|Botox injection into pylorus
355982|NCT00372970|E2|Reported Event|Placebo|saline Injection into pylorus
355983|NCT00372970|E1|Reported Event|Botox|Botox injection into pylorus
355984|NCT00372996|B3|Baseline|Total|Total of all reporting groups
355985|NCT00372996|B2|Baseline|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
355986|NCT00372996|B1|Baseline|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
355987|NCT00372996|P4|Participant Flow|Exemestane/CP-751,871 + Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
355988|NCT00372996|P3|Participant Flow|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356018|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
355989|NCT00372996|P2|Participant Flow|CP-751,871 + Exemestane/CP-751,871 + Fulvestrant|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
355990|NCT00372996|P1|Participant Flow|CP-751,871 Plus (+) Exemestane|Participants received CP-751,871 20 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle as an intravenous (IV) infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
355991|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
355992|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
355993|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
355994|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
355995|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
355996|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
355997|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
355998|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
355999|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356000|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356001|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356002|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356003|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356004|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356005|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356006|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356007|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356008|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356009|NCT00372996|E4|Reported Event|CP-751,871 + Exemestane (After Exemestane)|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
356010|NCT00372996|E3|Reported Event|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356011|NCT00372996|E2|Reported Event|CP-751,871 + Fulvestrant (After CP-751,871+Exemestane)|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
356012|NCT00372996|E1|Reported Event|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
356013|NCT00373113|B3|Baseline|Total|Total of all reporting groups
356014|NCT00373113|B2|Baseline|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
356015|NCT00373113|B1|Baseline|Sunitinib|37.5 mg daily, continuous dosing
356016|NCT00373113|P2|Participant Flow|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
356017|NCT00373113|P1|Participant Flow|Sunitinib|37.5 milligrams (mg) daily, continuous dosing
356019|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
356032|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
356033|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
356034|NCT00373113|E2|Reported Event|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
356035|NCT00373113|E1|Reported Event|Sunitinib|37.5 mg daily, continuous dosing
356036|NCT00373256|B3|Baseline|Total|Total of all reporting groups
356037|NCT00373256|B2|Baseline|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356038|NCT00373256|B1|Baseline|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356039|NCT00373256|P2|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab 10 milligrams per kilogram (mg/kg); infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356040|NCT00373256|P1|Participant Flow|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 milligrams (mg) daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 milligrams per square meter (mg/m^2), at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356041|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356042|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356043|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356044|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356045|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356046|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356047|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356048|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356049|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356050|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356051|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356052|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356053|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356086|NCT00373295|E1|Reported Event|Baclofen 60, Marijuana|"baclofen (60 mg)/day
Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo
Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
356054|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356055|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356056|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356057|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356058|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356059|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356060|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356061|NCT00373256|E2|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356062|NCT00373256|E1|Reported Event|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
356063|NCT00373269|B3|Baseline|Total|Total of all reporting groups
356064|NCT00373269|B2|Baseline|Hyperglycemic|Subjects with acute ischemic stroke and hyperglycemia.
356065|NCT00373269|B1|Baseline|Normoglycemic|Subjects with acute ischemic stroke and normal blood glucose.
356066|NCT00373269|P2|Participant Flow|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
356067|NCT00373269|P1|Participant Flow|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
356068|NCT00373269|O2|Outcome|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
356069|NCT00373269|O1|Outcome|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
356070|NCT00373269|O2|Outcome|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
356071|NCT00373269|O1|Outcome|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
356072|NCT00373269|E2|Reported Event|Normoglycemic Control|Subjects with acute stroke and normal blood glucose.
356073|NCT00373269|E1|Reported Event|Diabetic Subject|Subjects with acute stroke, hyperglycemia and history of diabetes.
356074|NCT00373295|B1|Baseline|All Study Participants|Participants received placebo, baclofen (60mg) and baclofen (90mg) and smoked Marijuana (5.3% THC).
356075|NCT00373295|P6|Participant Flow|Placebo, Baclofen 60 mg, Baclofen 90 mg|participants received placebo for 8 days, followed by baclofen (60mg/day) for 8 days, then baclofen (90mg/day) for 8 days.
356076|NCT00373295|P5|Participant Flow|Placebo, Baclofen 90 mg, Baclofen 60 mg|participants received placebo for 8 days, followed by baclofen (90mg/day) for 8 days, then baclofen (60mg/day) for 8 days.
356077|NCT00373295|P4|Participant Flow|Baclofen 90 mg, Baclofen 60 mg, Placebo|participants received baclofen (90mg/day) for 8 days, followed by baclofen (60mg/day) for 8 days, and then placebo for 8 days.
356078|NCT00373295|P3|Participant Flow|Baclofen 60 mg, Baclofen 90 mg, Placebo|participants received baclofen (60mg/day) for 8 days, followed by baclofen (90mg/day) for 8 days, then placebo for 8 days.
356079|NCT00373295|P2|Participant Flow|Baclofen 90 mg, Placebo, Baclofen 60 mg|participants received baclofen (90mg/day) for 8 days, followed by placebo for 8 days, then baclofen (60mg/day) for 8 days.
356080|NCT00373295|P1|Participant Flow|Baclofen 60 mg, Placebo, Baclofen 90 mg|participants received baclofen (60 mg/day) for 8 days, followed by placebo for 8 days, then baclofen (90mg/day) for 8 days.
356369|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356081|NCT00373295|O3|Outcome|Baclofen 90, Marijuana|"baclofen (90 mg)/day
Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo
Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
356082|NCT00373295|O2|Outcome|Placebo, Marijuana|
356083|NCT00373295|O1|Outcome|Baclofen 60, Marijuana|"baclofen (60 mg)/day
Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo
Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
356084|NCT00373295|E3|Reported Event|Placebo, Marijuana|Marijuana: measured baclofen's effects on marijuana withdrawal and relapse
356085|NCT00373295|E2|Reported Event|Baclofen 90, Marijuana|"baclofen (90 mg)/day
Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo
Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
356087|NCT00373334|B4|Baseline|Total|Total of all reporting groups
356091|NCT00373334|P3|Participant Flow|Placebo|"Placebo plus Conservative Measures
Conservative Measures included:
Hypoallergenic formula thickened with dry rice cereal Avoidance of seated and supine positioning Elimination of tobacco smoke exposure"
356092|NCT00373334|P2|Participant Flow|Nizatidine 5.0 mg/kg Twice Daily|high dose nizatidine plus Conservative Measures
356093|NCT00373334|P1|Participant Flow|Nizatidine 2.5 mg/kg Twice Daily|low dose nizatidine plus Conservative Measures
356094|NCT00373334|O3|Outcome|Conservative Measures Only|
356095|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
356096|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
356097|NCT00373334|O3|Outcome|Conservative Measures Only|
356098|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
356099|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
356100|NCT00373334|O3|Outcome|Conservative Measures Only|
356101|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
356102|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
356103|NCT00373334|E3|Reported Event|Conservative Measures Only|
356104|NCT00373334|E2|Reported Event|Nizatidine 5.0 mg/kg b.i.d.|
356105|NCT00373334|E1|Reported Event|Nizatidine 2.5 mg/kg b.i.d.|
356106|NCT00373360|B1|Baseline|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356107|NCT00373360|P1|Participant Flow|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356108|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356109|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356110|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356111|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356112|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356113|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356114|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356115|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356116|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356117|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356118|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356119|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356120|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356121|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356122|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356123|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356124|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356125|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356126|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356127|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356128|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356129|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356130|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356131|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356132|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356133|NCT00373360|E1|Reported Event|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
356134|NCT00373425|B6|Baseline|Total|Total of all reporting groups
356135|NCT00373425|B5|Baseline|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
356136|NCT00373425|B4|Baseline|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
356137|NCT00373425|B3|Baseline|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
356138|NCT00373425|B2|Baseline|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356139|NCT00373425|B1|Baseline|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356140|NCT00373425|P5|Participant Flow|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
356170|NCT00373490|B1|Baseline|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
361076|NCT00386334|O1|Outcome|Placebo|Placebo tablets
356141|NCT00373425|P4|Participant Flow|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
356142|NCT00373425|P3|Participant Flow|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
356143|NCT00373425|P2|Participant Flow|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356144|NCT00373425|P1|Participant Flow|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356145|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356146|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356147|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356148|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356149|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356150|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356151|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356152|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356153|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356154|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356155|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356156|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356157|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356158|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356159|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356160|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356161|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356162|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356163|NCT00373425|E5|Reported Event|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
356370|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356371|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356164|NCT00373425|E4|Reported Event|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
356165|NCT00373425|E3|Reported Event|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
356166|NCT00373425|E2|Reported Event|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356167|NCT00373425|E1|Reported Event|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
356171|NCT00373490|P2|Participant Flow|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
356172|NCT00373490|P1|Participant Flow|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
356173|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
356174|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
356175|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
356176|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
356177|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
356178|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
356179|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
356180|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
356181|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
356182|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
356183|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
356184|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
356185|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
356186|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
356187|NCT00373490|E2|Reported Event|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
356188|NCT00373490|E1|Reported Event|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
356189|NCT00373529|B1|Baseline|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
356190|NCT00373529|P1|Participant Flow|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
356191|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
356192|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
356193|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
356194|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
356195|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
356196|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
356372|NCT00374244|E2|Reported Event|Active Pimozide|Half of the subjects are randomized to the active drug.
356373|NCT00374244|E1|Reported Event|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356197|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
356198|NCT00373529|E1|Reported Event|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
356199|NCT00373685|B3|Baseline|Total|Total of all reporting groups
356200|NCT00373685|B2|Baseline|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356201|NCT00373685|B1|Baseline|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356202|NCT00373685|P2|Participant Flow|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356203|NCT00373685|P1|Participant Flow|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356204|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356205|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356206|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356207|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356208|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356209|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356210|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356211|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356212|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356213|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356214|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356215|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356216|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356217|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356218|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356219|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356220|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356221|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356222|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356223|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356224|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356225|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356226|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356227|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356228|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356229|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356230|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356231|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356232|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356233|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356234|NCT00373685|E2|Reported Event|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
356235|NCT00373685|E1|Reported Event|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
356236|NCT00373698|B3|Baseline|Total|Total of all reporting groups
356237|NCT00373698|B2|Baseline|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
356238|NCT00373698|B1|Baseline|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
356239|NCT00373698|P2|Participant Flow|Usual Care|"Participants randomized to Usual Care received care at the VA provider's discretion and could include referral to mental health specialty care."
356374|NCT00374322|B3|Baseline|Total|Total of all reporting groups
357180|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
356240|NCT00373698|P1|Participant Flow|Three Component Model of Collaborative Care and Usual Care|"Participants randomized to this arm received the Three Component Model of Collaborative Care (3CM) as well as usual care. 3CM model consists of 1) education and tools for primary care clinicians and staff including content regarding PTSD; 2) telephone care management by a centrally located care manager (the purpose of the calls was to identify barriers to adherance with the primary care provider's plan, aid participant to overcome them, and measure treatment response. Calls occurred 1, 4, and 8 weeks after the initial visit and then every 4 weeks for 6 months or until a participant acheived 30% reduction in PTSD symptoms as measure by the PCL); 3) support from a psychiatrist who supervises care managers by telephone, provides consultation to primary care clinicians, and facilitates mental health referral. Participant's Usual Care is at the VA provider's discretion and could include referral to mental health specialty care.specialty care."
356241|NCT00373698|O2|Outcome|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
356242|NCT00373698|O1|Outcome|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
356243|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
356575|NCT00368641|E1|Reported Event|Intervention Group|Addition of peritoneal ultrafiltration
356244|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
356245|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
356246|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
356247|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
356248|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
356249|NCT00373698|E2|Reported Event|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
356250|NCT00373698|E1|Reported Event|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
356251|NCT00373958|B3|Baseline|Total|Total of all reporting groups
356252|NCT00373958|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356253|NCT00373958|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356254|NCT00373958|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356255|NCT00373958|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356256|NCT00373958|O4|Outcome|7vPnC After the Toddler Dose|Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
356257|NCT00373958|O3|Outcome|13vPnC After the Toddler Dose|Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
356258|NCT00373958|O2|Outcome|7vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
356259|NCT00373958|O1|Outcome|13vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
356260|NCT00373958|O4|Outcome|7vPnC After Toddler Dose|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
356261|NCT00373958|O3|Outcome|13vPnC After Toddler Dose|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
356262|NCT00373958|O2|Outcome|7vPnC After Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
357282|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
356263|NCT00373958|O1|Outcome|13vPnC After Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
356264|NCT00373958|O8|Outcome|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356265|NCT00373958|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356266|NCT00373958|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
356576|NCT00368745|B3|Baseline|Total|Total of all reporting groups
361077|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
356267|NCT00373958|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
356268|NCT00373958|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
356269|NCT00373958|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
356270|NCT00373958|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
356271|NCT00373958|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
356272|NCT00373958|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356273|NCT00373958|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356274|NCT00373958|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
356275|NCT00373958|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
356276|NCT00373958|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
356277|NCT00373958|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
356278|NCT00373958|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
356279|NCT00373958|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
356280|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356375|NCT00374322|B2|Baseline|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356431|NCT00374803|P1|Participant Flow|Myfortic 1080mg BID, 720mg BID|Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
359375|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
356281|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356282|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356283|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356284|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356285|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356286|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356287|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356288|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356289|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356290|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356291|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356401|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356292|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356293|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356294|NCT00373958|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
356295|NCT00373958|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
356296|NCT00373958|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356297|NCT00373958|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
356298|NCT00373958|E4|Reported Event|7vPnC Post Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
356299|NCT00373958|E3|Reported Event|13vPnC Post Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
356300|NCT00373958|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
356301|NCT00373958|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
356302|NCT00374088|B3|Baseline|Total|Total of all reporting groups
356303|NCT00374088|B2|Baseline|N-acetylcysteine|Patients treated with N-acetylcysteine
356304|NCT00374088|B1|Baseline|Placebo|Patients not treated with N-acetylcysteine
356305|NCT00374088|P2|Participant Flow|N-acetylcysteine|Patients treated with N-acetylcysteine
356306|NCT00374088|P1|Participant Flow|Placebo|Patients not treated with N-acetylcysteine
356307|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
356308|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
356309|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
356310|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
356311|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
356312|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
356313|NCT00374088|E2|Reported Event|N-acetylcysteine|Patients treated with N-acetylcysteine
356314|NCT00374088|E1|Reported Event|Placebo|Patients not treated with N-acetylcysteine
356315|NCT00374140|B1|Baseline|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
356316|NCT00374140|P1|Participant Flow|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
356317|NCT00374140|O1|Outcome|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
356318|NCT00374140|E1|Reported Event|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
356319|NCT00374231|B1|Baseline|Tacrolimus and Mycophenolate Mofetil|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
356320|NCT00374231|P1|Participant Flow|Corticosteroid Withdrawal|Discontinue prednisone at 90 days or longer post liver transplant if rejection free previous 30 days.
356376|NCT00374322|B1|Baseline|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356377|NCT00374322|P2|Participant Flow|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356321|NCT00374231|O1|Outcome|Corticosteroid Withdrawal|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
356380|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356535|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
356322|NCT00374231|O1|Outcome|Corticosteroid Withdrawal|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
356323|NCT00374231|O1|Outcome|Corticosteroid Withdrawa.|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
356324|NCT00374231|E1|Reported Event|Tacrolimus and Mycophenolate Mofetil|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
356325|NCT00374244|B3|Baseline|Total|Total of all reporting groups
356326|NCT00374244|B2|Baseline|Active Pimozide|Half of the subjects are randomized to the active drug.
356327|NCT00374244|B1|Baseline|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356328|NCT00374244|P2|Participant Flow|Active Pimozide|Half of the subjects are randomized to the active drug.
356329|NCT00374244|P1|Participant Flow|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356330|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356331|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356332|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356333|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356334|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356335|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356336|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356337|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356338|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356339|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356340|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356341|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356342|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356343|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356344|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356345|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356346|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356347|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356348|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356349|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356350|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356351|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356352|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356353|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356354|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356355|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356356|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356357|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356358|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356359|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356360|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356361|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
356362|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
356363|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
359376|NCT00382993|O1|Outcome|Placebo|
356378|NCT00374322|P1|Participant Flow|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356379|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356381|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356382|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356383|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356384|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356385|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356386|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356387|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356388|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356389|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356390|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356391|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356392|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356393|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal
356394|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356395|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356396|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356397|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356398|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356399|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356400|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356510|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
356402|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356403|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356404|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356405|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356406|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356407|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356408|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356409|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356410|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356411|NCT00374322|E2|Reported Event|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356412|NCT00374322|E1|Reported Event|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
356413|NCT00374335|B1|Baseline|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
356414|NCT00374335|P1|Participant Flow|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
356415|NCT00374335|O1|Outcome|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
356416|NCT00374335|O1|Outcome|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
356417|NCT00374335|E1|Reported Event|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
356418|NCT00374543|B3|Baseline|Total|Total of all reporting groups
356419|NCT00374543|B2|Baseline|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
356420|NCT00374543|B1|Baseline|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
356421|NCT00374543|P2|Participant Flow|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
356422|NCT00374543|P1|Participant Flow|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
356423|NCT00374543|O2|Outcome|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
356424|NCT00374543|O1|Outcome|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
356425|NCT00374543|E2|Reported Event|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
356426|NCT00374543|E1|Reported Event|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
356427|NCT00374803|B3|Baseline|Total|Total of all reporting groups
356428|NCT00374803|B2|Baseline|Myfortic 720 mg Twice Daily|Myfortic 720 mg twice daily (1440 mg/day).
356429|NCT00374803|B1|Baseline|Myfortic 1080mg BID, 720mg BID|Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
356511|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
356432|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
356433|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
356434|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
356569|NCT00368641|B1|Baseline|Intervention Group|Addition of peritoneal ultrafiltration
356435|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
356436|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
356437|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
356438|NCT00374803|O2|Outcome|Mycophenolic Acid (Myfortic) Standard|"Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).
Mycophenolic Acid (Myfortic): • Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
• Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
356439|NCT00374803|O1|Outcome|Mycophenolic Acid (Myfortic) Preload|"Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
Mycophenolic Acid (Myfortic): • Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
• Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
356440|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
356441|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
356442|NCT00374803|E2|Reported Event|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
356443|NCT00374803|E1|Reported Event|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
356444|NCT00374842|B4|Baseline|Total|Total of all reporting groups
356445|NCT00374842|B3|Baseline|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356446|NCT00374842|B2|Baseline|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356447|NCT00374842|B1|Baseline|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356448|NCT00374842|P3|Participant Flow|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356449|NCT00374842|P2|Participant Flow|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356450|NCT00374842|P1|Participant Flow|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356451|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356452|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356453|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
356454|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356455|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356512|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
356513|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
356514|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
356456|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356457|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356533|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
356458|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356459|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
356460|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356461|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356462|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
356463|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356464|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
356465|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
356466|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356467|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356468|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
356469|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356470|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356471|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
356472|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356473|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356474|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
356475|NCT00374842|E3|Reported Event|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
356476|NCT00374842|E2|Reported Event|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356477|NCT00374842|E1|Reported Event|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
356478|NCT00374868|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
356515|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
356516|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
356479|NCT00374868|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
356534|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
356480|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
356481|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
356482|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
356483|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
356484|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
356485|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
356486|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
356487|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
356488|NCT00374868|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
356489|NCT00374907|B3|Baseline|Total|Total of all reporting groups
356490|NCT00374907|B2|Baseline|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
356491|NCT00374907|B1|Baseline|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
356492|NCT00374907|P2|Participant Flow|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, up to 104 weeks starting at Week 12 (end of ST period). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
356493|NCT00374907|P1|Participant Flow|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
356494|NCT00374907|O2|Outcome|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
356495|NCT00374907|O1|Outcome|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
356496|NCT00374907|O2|Outcome|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
356497|NCT00374907|O1|Outcome|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
356498|NCT00374907|O2|Outcome|Short Term Period: Placebo|Tablet, Oral, 0 mg, once daily, up to 12 weeks
356499|NCT00374907|O1|Outcome|Short Term Period: Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks
356500|NCT00374907|O2|Outcome|Short Term Period: Placebo|Tablet, Oral, 0 mg, once daily, up to 12 weeks
356501|NCT00374907|O1|Outcome|Short Term Period: Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks
356502|NCT00374907|E2|Reported Event|SAXAGLIPTIN 5 MG|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short term); Tablet, Oral, 5 mg, once daily, up to 104 weeks (long term)
356503|NCT00374907|E1|Reported Event|PLACEBO/METFORMIN|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks (short term); Metformin Tablet, Oral, 500 mg titrated to 1000 mg, once daily, up to 104 weeks (long term)
356504|NCT00368459|B3|Baseline|Total|Total of all reporting groups
356505|NCT00368459|B2|Baseline|Placebo|identical appearing oral placebo
356506|NCT00368459|B1|Baseline|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
356507|NCT00368459|P2|Participant Flow|Placebo|identical appearing oral placebo
356508|NCT00368459|P1|Participant Flow|Raloxifene|"oral raloxifene 120 mg once daily
raloxifene"
356509|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
356531|NCT00368472|B1|Baseline|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
356532|NCT00368472|P1|Participant Flow|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
356536|NCT00368472|E1|Reported Event|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
356537|NCT00368537|B3|Baseline|Total|Total of all reporting groups
356538|NCT00368537|B2|Baseline|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
356539|NCT00368537|B1|Baseline|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
356540|NCT00368537|P2|Participant Flow|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
356541|NCT00368537|P1|Participant Flow|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
356542|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
356543|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
356544|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
356545|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
356546|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
356547|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
356548|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
356549|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
356550|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
356551|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
356552|NCT00368537|E2|Reported Event|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
356553|NCT00368537|E1|Reported Event|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
356554|NCT00368550|B3|Baseline|Total|Total of all reporting groups
356555|NCT00368550|B2|Baseline|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
356556|NCT00368550|B1|Baseline|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
356557|NCT00368550|P2|Participant Flow|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
356558|NCT00368550|P1|Participant Flow|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
356559|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
356560|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
356561|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
356562|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
357072|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
356563|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
356564|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
356565|NCT00368550|E2|Reported Event|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
356566|NCT00368550|E1|Reported Event|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
356567|NCT00368641|B3|Baseline|Total|Total of all reporting groups
356568|NCT00368641|B2|Baseline|Standard Therapy|Standard therapy for CHF
356577|NCT00368745|B2|Baseline|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356578|NCT00368745|B1|Baseline|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356579|NCT00368745|P2|Participant Flow|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356580|NCT00368745|P1|Participant Flow|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356581|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356582|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356583|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356584|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356664|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356585|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356586|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356587|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356588|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356589|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356590|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356591|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356592|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356593|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356594|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356595|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356665|NCT00368966|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
356596|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356597|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356598|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356599|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356600|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356601|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356602|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356603|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356604|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356605|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356606|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356666|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
356607|NCT00368745|E2|Reported Event|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
356608|NCT00368745|E1|Reported Event|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
356609|NCT00368849|B1|Baseline|All Participants|Age, sex, and region of enrollment were available for all 20 participants.
356610|NCT00368849|P2|Participant Flow|Placebo (4 Weeks) Then Atomoxetine (4 Weeks)|Participants received twice a day matching placebo for four weeks. After a two week washout, they then received 40 milligram twice a day atomoxetine for four weeks.
356611|NCT00368849|P1|Participant Flow|Atomoxetine (4 Weeks) Then Placebo (4 Weeks)|Participants received 40 milligram twice a day atomoxetine for four weeks. After a two week wash out, they then received twice a day matching placebo for four weeks.
356612|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
356613|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
356614|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
356615|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
356616|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
356617|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
356618|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
356619|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
356620|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
356621|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine
356622|NCT00368849|E2|Reported Event|Matching Placebo|Individuals in this arm received twice a day matching placebo.
356623|NCT00368849|E1|Reported Event|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
356624|NCT00368875|B1|Baseline|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.
Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
356625|NCT00368875|P2|Participant Flow|Phase II|"Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
356626|NCT00368875|P1|Participant Flow|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
356627|NCT00368875|O1|Outcome|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
356628|NCT00368875|O1|Outcome|Vorinostat, Paclitaxel, Bevacizumab|"Vorinostat BID on days 1-3, 8-10, and 15-17, paclitaxel IV over 1 hour on days 2, 9, and 16, bevacizumab IV over 30-90 minutes on days 2 and 16, repeat every 28 days.
vorinostat: Given orally
paclitaxel: Given IV
bevacizumab: Given IV"
356629|NCT00368875|O1|Outcome|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.
Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
356667|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
357116|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
356630|NCT00368875|O1|Outcome|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.
Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
356631|NCT00368875|O1|Outcome|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
356653|NCT00368940|O2|Outcome|ST-CI|"Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
356632|NCT00368875|E1|Reported Event|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.
Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.
All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
356633|NCT00368927|B3|Baseline|Total|Total of all reporting groups
356634|NCT00368927|B2|Baseline|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
356635|NCT00368927|B1|Baseline|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
356636|NCT00368927|P2|Participant Flow|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
356637|NCT00368927|P1|Participant Flow|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
356638|NCT00368927|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
356639|NCT00368927|O1|Outcome|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
356640|NCT00368927|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
356641|NCT00368927|O1|Outcome|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
356642|NCT00368927|E2|Reported Event|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
356643|NCT00368927|E1|Reported Event|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
356644|NCT00368940|B3|Baseline|Total|Total of all reporting groups
356645|NCT00368940|B2|Baseline|ST-CI|"Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
356646|NCT00368940|B1|Baseline|PATH|"Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
356647|NCT00368940|P2|Participant Flow|ST-CI|"Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
356648|NCT00368940|P1|Participant Flow|PATH|"Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
356649|NCT00368940|O2|Outcome|ST-CI|"Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
356650|NCT00368940|O1|Outcome|PATH|"Participants will receive PATH for 12 weeks
PATH: PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
356651|NCT00368940|O2|Outcome|ST-CI|"Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
356652|NCT00368940|O1|Outcome|PATH|"Participants will receive PATH for 12 weeks
PATH: PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
356676|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356677|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
356654|NCT00368940|O1|Outcome|PATH|"Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
356655|NCT00368940|O2|Outcome|ST-CI|"Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
356656|NCT00368940|O1|Outcome|PATH|"Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
356657|NCT00368940|E2|Reported Event|ST-CI|"Participants will receive ST-CI for 12 weeks
ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
356658|NCT00368940|E1|Reported Event|PATH|"Participants will receive PATH for 12 weeks
PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
356659|NCT00368966|B3|Baseline|Total|Total of all reporting groups
356660|NCT00368966|B2|Baseline|7vPnC|Subjects received 1 dose (0.5 mL) of 7vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 7vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 7vPnC and Infanrix-IPV+Hib, Meningitec.
356661|NCT00368966|B1|Baseline|13vPnC|Subjects received 1 dose (0.5 mL) of 13vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 13vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 13vPnC and Infanrix-IPV+Hib, Meningitec.
356662|NCT00368966|P2|Participant Flow|7vPnC|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
356663|NCT00368966|P1|Participant Flow|13vPnC|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
356668|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356669|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
356670|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
356671|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356672|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356673|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
356674|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
356675|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356678|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
356679|NCT00368966|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months.
356680|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356681|NCT00368966|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
356682|NCT00368966|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
356683|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356684|NCT00368966|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
356685|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months (infant series).
356686|NCT00368966|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356687|NCT00368966|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356688|NCT00368966|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
356689|NCT00368966|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
356690|NCT00368966|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
356691|NCT00368966|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
356692|NCT00368966|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
356693|NCT00368966|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
356694|NCT00368966|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356695|NCT00368966|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356696|NCT00368966|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
356697|NCT00368966|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
356698|NCT00368966|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
356699|NCT00368966|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
356700|NCT00368966|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
356701|NCT00368966|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
356702|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
357176|NCT00376168|P2|Participant Flow|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
356703|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356704|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356705|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months(toddler dose).
356736|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
356737|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
356738|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
356706|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356707|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
356708|NCT00368966|E8|Reported Event|7vPnC 6-Month Follow-up|Assessment was done approximately 6 months after 7vPnC toddler dose at 21 months of age.
356709|NCT00368966|E7|Reported Event|13vPnC 6-Month Follow-up|Assessment was done approximately 6 months after 13vPnC toddler dose at 21 months of age.
356710|NCT00368966|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
356711|NCT00368966|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
356712|NCT00368966|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age.
356713|NCT00368966|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series), assessment was done approximately one month after dose 3 at 7 months of age.
356714|NCT00368966|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
356715|NCT00368966|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
356716|NCT00368979|B3|Baseline|Total|Total of all reporting groups
356717|NCT00368979|B2|Baseline|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356718|NCT00368979|B1|Baseline|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356719|NCT00368979|P2|Participant Flow|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356720|NCT00368979|P1|Participant Flow|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356721|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356722|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356723|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356724|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356725|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356726|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356727|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356728|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356729|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356730|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356731|NCT00368979|E2|Reported Event|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356732|NCT00368979|E1|Reported Event|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
356733|NCT00368992|B1|Baseline|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
356734|NCT00368992|P1|Participant Flow|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|"This was a single arm Phase II trial. Patients were treated with induction therapy cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients who were not removed due to unacceptable toxicity or disease progression were then treated with maintenance therapy cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
356735|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
356739|NCT00368992|E1|Reported Event|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
356740|NCT00369122|B1|Baseline|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.
Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
356741|NCT00369122|P1|Participant Flow|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.
Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
356742|NCT00369122|O1|Outcome|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.
Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
356743|NCT00369122|E1|Reported Event|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.
Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
Data is reported for all patients who received study treatment, which is 59 patients."
356744|NCT00369161|B3|Baseline|Total|Total of all reporting groups
356745|NCT00369161|B2|Baseline|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
356746|NCT00369161|B1|Baseline|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
356747|NCT00369161|P2|Participant Flow|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
359377|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
356748|NCT00369161|P1|Participant Flow|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
356749|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
356750|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
356751|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
356752|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
356753|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
356754|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
356791|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
356792|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
356902|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
359378|NCT00382993|O1|Outcome|Placebo|
356755|NCT00369161|E2|Reported Event|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
356756|NCT00369161|E1|Reported Event|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
356761|NCT00369226|P1|Participant Flow|Phase I (45 Days)|Bortezomib plus tacrolimus and methotrexate after mismatched allogeneic non-myeloablative hematopoietic stem cell transplantation (HSCT).
356762|NCT00369226|O2|Outcome|Overall Survival (OS)|This reports on all treated patients across both phase I and phase II (n=45)
356763|NCT00369226|O1|Outcome|Progression-free Survival (PFS)|This reports on all treated patients across both phase I and phase II (n=45)
356764|NCT00369226|O1|Outcome|Phase I and Phase II|This reports on all treated patients across both phase I and phase II (n=45)
356765|NCT00369226|O1|Outcome|Phase I and Phase II|Engraftment is determined for all treated patients across both phase I and phase II (n=45) who are evaluable for this endpoint (n=35)
356766|NCT00369226|O1|Outcome|Phase I and Phase II|This reports on all treated patients across both phase I and phase II (n=45)
356767|NCT00369226|O1|Outcome|Combined Phase I Plus Phase II|This reports on the total phase I plus phase II patients who were evaluable for chimerism endpoint (37 of the 45 patients).
356768|NCT00369226|O1|Outcome|Phase I|
356769|NCT00369226|E1|Reported Event|Phase I-II|
356770|NCT00369265|B3|Baseline|Total|Total of all reporting groups
356771|NCT00369265|B2|Baseline|Lansoprazole|Lansoprazole 30 mg twice daily
356772|NCT00369265|B1|Baseline|Sugar Pill|Placebo for Lansoprazole twice daily
356773|NCT00369265|P2|Participant Flow|Lansoprazole|Lansoprazole 30 mg twice daily
356774|NCT00369265|P1|Participant Flow|Sugar Pill|Placebo for Lansoprazole twice daily
356775|NCT00369265|O2|Outcome|Lansoprazole|Lansoprazole 30 mg twice daily
356776|NCT00369265|O1|Outcome|Sugar Pill|Placebo for Lansoprazole twice daily
356777|NCT00369265|E2|Reported Event|Lansoprazole|Lansoprazole 30 mg twice daily
356778|NCT00369265|E1|Reported Event|Sugar Pill|Placebo for Lansoprazole twice daily
356779|NCT00369278|B3|Baseline|Total|Total of all reporting groups
356780|NCT00369278|B2|Baseline|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
356781|NCT00369278|B1|Baseline|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
356782|NCT00369278|P2|Participant Flow|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
356783|NCT00369278|P1|Participant Flow|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
356784|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
356785|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
356786|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
356787|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
356788|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
356789|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
356790|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
356903|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
356793|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
356794|NCT00369278|E2|Reported Event|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study (month 6): 1440 mg/day (2 x 720 mg)
356795|NCT00369278|E1|Reported Event|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
356796|NCT00369317|B1|Baseline|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I
INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM
daunorubicin hydrochloride: Given IV
cytarabine: Given IV or IT
thioguanine: Given orally
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
356856|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
361078|NCT00386334|O1|Outcome|Placebo|Placebo tablets
356797|NCT00369317|P1|Participant Flow|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I
INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM
daunorubicin hydrochloride: Given IV
cytarabine: Given IV or IT
thioguanine: Given orally
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
356798|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.
COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
356799|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I
INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM
daunorubicin hydrochloride: Given IV
cytarabine: Given IV or IT
thioguanine: Given orally
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
356800|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I
INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM
daunorubicin hydrochloride: Given IV
cytarabine: Given IV or IT
thioguanine: Given orally
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
356801|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.
COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
356802|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.
COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
359379|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
356803|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.
COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
356813|NCT00369343|P2|Participant Flow|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356913|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
356914|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
356804|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.
COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
356805|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.
COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
356806|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.
COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
356807|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.
COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
356808|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.
COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
356809|NCT00369317|E1|Reported Event|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I
INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
asparaginase: Given IM
daunorubicin hydrochloride: Given IV
cytarabine: Given IV or IT
thioguanine: Given orally
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
356810|NCT00369343|B3|Baseline|Total|Total of all reporting groups
356811|NCT00369343|B2|Baseline|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356904|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
357177|NCT00376168|P1|Participant Flow|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
356812|NCT00369343|B1|Baseline|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356915|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
356814|NCT00369343|P1|Participant Flow|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356815|NCT00369343|O3|Outcome|200 mg|DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
356816|NCT00369343|O2|Outcome|100 mg|DVS SR 100mg dosage was reduced to DVS SR 50mg for 7 days.
356817|NCT00369343|O1|Outcome|0 mg|Placebo
356818|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
356819|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
356820|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
356821|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
356822|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
356823|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
356824|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
356825|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
356826|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
356827|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
356828|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
356829|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
356830|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356831|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356832|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356833|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356834|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356852|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356835|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356836|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356837|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356838|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356839|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356840|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356841|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
356842|NCT00369343|E4|Reported Event|Open-label Placebo/DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
356843|NCT00369343|E3|Reported Event|Open-label DVS SR/ DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
356844|NCT00369343|E2|Reported Event|Double-blind Placebo|Placebo administered daily for 8 weeks
356845|NCT00369343|E1|Reported Event|Double-blind DVS SR|"Days 1 to 7:
Patients will be instructed to take 1-50mg tablet per day
Days 8 to 14:
Patients will be instructed to take 1-100mg tablet per day
Days 15 to 56:
At the discretion of the investigator, patients may be assigned to 100mg or 200mg tablets per day"
356846|NCT00369382|B3|Baseline|Total|Total of all reporting groups
356847|NCT00369382|B2|Baseline|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356848|NCT00369382|B1|Baseline|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356849|NCT00369382|P2|Participant Flow|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356850|NCT00369382|P1|Participant Flow|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356851|NCT00369382|O1|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356900|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
356853|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356854|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356855|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356857|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356858|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356859|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356860|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356861|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356862|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356863|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356864|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356865|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356866|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356867|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356868|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356869|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356870|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356901|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
359380|NCT00382993|O1|Outcome|Placebo|
356871|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356872|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356873|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356874|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356875|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356876|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356877|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356878|NCT00369382|E2|Reported Event|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
356879|NCT00369382|E1|Reported Event|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
356880|NCT00369486|B6|Baseline|Total|Total of all reporting groups
356881|NCT00369486|B5|Baseline|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
356882|NCT00369486|B4|Baseline|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
356883|NCT00369486|B3|Baseline|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
356884|NCT00369486|B2|Baseline|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
356885|NCT00369486|B1|Baseline|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
356886|NCT00369486|P5|Participant Flow|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
356887|NCT00369486|P4|Participant Flow|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
356888|NCT00369486|P3|Participant Flow|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
356889|NCT00369486|P2|Participant Flow|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
356890|NCT00369486|P1|Participant Flow|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
356891|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
356892|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
356893|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
356894|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
356895|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
356896|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
356897|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
356898|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
356899|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
359381|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
356905|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
356906|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
356907|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
356908|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
356909|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
356910|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
356911|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
356912|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
356916|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
356917|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
356918|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
356919|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
356920|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
356921|NCT00369486|E5|Reported Event|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
356922|NCT00369486|E4|Reported Event|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
356923|NCT00369486|E3|Reported Event|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
356924|NCT00369486|E2|Reported Event|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
356925|NCT00369486|E1|Reported Event|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
356926|NCT00369512|B1|Baseline|Erlotinib|Erlotinib therapy for 2 weeks (150 mg once per day)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg once per day).
356927|NCT00369512|P1|Participant Flow|Erlotinib|Erlotinib therapy for 2 weeks (150 mg by mouth (PO) every day(QD))(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
356928|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
356929|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
356930|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
356931|NCT00369512|E1|Reported Event|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
356932|NCT00369564|B3|Baseline|Total|Total of all reporting groups
356933|NCT00369564|B2|Baseline|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
356934|NCT00369564|B1|Baseline|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
356935|NCT00369564|P2|Participant Flow|Arm II Placebo|"Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Placebo capsules are identical in appearance to the active oral glutamic acid capsules but instead each capsule contains 324 mg of microcrystalline cellulose as a filler, 3 mg of magnesium stearate as a lubricant and 3 mg silicone dioxide as a drying agent for a total fill weight of 330 mg. The manufacturer has certified that the placebo contains no active agent.
Patients with a body surface area (BSA) less than 1.0 m^2 will receive a 1 capsule of placebo 3 times daily (total 3 capsules daily). Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a 2 placebo capsules 3 times daily (total 6 capsules daily). ."
356936|NCT00369564|P1|Participant Flow|Arm I Glutamic Acid|Patients receive oral l-glutamic acid hydrocloride 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Patients with a body surface area (BSA) less than 1.0 m^2 will receive a total of 750 mg/day of oral glutamic acid . Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a total of 1500 mg/day of oral glutamic acid .
359382|NCT00382993|O1|Outcome|Placebo|
356937|NCT00369564|O2|Outcome|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
356938|NCT00369564|O1|Outcome|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
356939|NCT00369564|E2|Reported Event|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
356940|NCT00369564|E1|Reported Event|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
356941|NCT00369590|B3|Baseline|Total|Total of all reporting groups
356942|NCT00369590|B2|Baseline|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356943|NCT00369590|B1|Baseline|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356965|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
357133|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
356944|NCT00369590|P2|Participant Flow|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356945|NCT00369590|P1|Participant Flow|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356946|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356947|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356948|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356949|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356950|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356951|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356952|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356953|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356954|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356955|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356956|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356957|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
357283|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
356958|NCT00369590|E1|Reported Event|All Study Patients|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis.
ziv-aflibercept: Given IV
pharmacological study: correlative studies
laboratory biomarker analysis: correlative studies"
356959|NCT00369655|B1|Baseline|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
356960|NCT00369655|P1|Participant Flow|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
356961|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
356962|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
356963|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
356964|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
357134|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
356966|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
356967|NCT00369655|E1|Reported Event|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
356968|NCT00369668|B4|Baseline|Total|Total of all reporting groups
356969|NCT00369668|B3|Baseline|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
356970|NCT00369668|B2|Baseline|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
356971|NCT00369668|B1|Baseline|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
356972|NCT00369668|P3|Participant Flow|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
356973|NCT00369668|P2|Participant Flow|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
356974|NCT00369668|P1|Participant Flow|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
356975|NCT00369668|O3|Outcome|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
356976|NCT00369668|O2|Outcome|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
356977|NCT00369668|O1|Outcome|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
356978|NCT00369668|O3|Outcome|Control|Bilateral movements coupled with sham neuromuscular electrical stimulation. Two times per week for two weeks.
356979|NCT00369668|O2|Outcome|Low Intensity|Bilateral movements coupled with neuromuscular electrical stimulation. Two times per week for two weeks.
356980|NCT00369668|O1|Outcome|High Intensity|Bilateral movements coupled with neuromuscular electrical stimulation. Four times per week for two weeks.
356981|NCT00369668|O3|Outcome|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
356982|NCT00369668|O2|Outcome|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
356983|NCT00369668|O1|Outcome|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
356984|NCT00369668|E3|Reported Event|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
356985|NCT00369668|E2|Reported Event|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
356986|NCT00369668|E1|Reported Event|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
356987|NCT00375219|B4|Baseline|Total|Total of all reporting groups
356988|NCT00375219|B3|Baseline|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
356989|NCT00375219|B2|Baseline|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
356990|NCT00375219|B1|Baseline|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357069|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
356991|NCT00375219|P3|Participant Flow|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
356992|NCT00375219|P2|Participant Flow|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
356993|NCT00375219|P1|Participant Flow|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357080|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357081|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
356994|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
356995|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
356996|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
356997|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
356998|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
356999|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357000|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357001|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357002|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357003|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357004|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357284|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
357005|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357006|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357007|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357008|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357009|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357010|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357011|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357012|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357013|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357014|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357015|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357016|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357017|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357018|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357178|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
357019|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357020|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357021|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357022|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357023|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357024|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357025|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357026|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357027|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357028|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357029|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357030|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357031|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357032|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357179|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
357033|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357034|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357035|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357131|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357036|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357037|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357038|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357039|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357040|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357041|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357042|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357043|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357044|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357045|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357046|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357070|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357071|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
359383|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
357047|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357048|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357049|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357050|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357051|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357052|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357053|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357054|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357055|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357056|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
357057|NCT00375219|E1|Reported Event|Omacetaxine|Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
357058|NCT00375674|B3|Baseline|Total|Total of all reporting groups
357059|NCT00375674|B2|Baseline|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357060|NCT00375674|B1|Baseline|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357061|NCT00375674|P2|Participant Flow|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357062|NCT00375674|P1|Participant Flow|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357063|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357064|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357065|NCT00375674|O2|Outcome|Placebo|"Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
Note: n= number of participants with observation of interest"
357066|NCT00375674|O1|Outcome|Sunitinib|"Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
Note: n= number of participants with observation of interest"
357067|NCT00375674|O2|Outcome|Placebo|"Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
Note: n = number of participants with observation of interest"
357068|NCT00375674|O1|Outcome|Sunitinib|"Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
Note: n = number of participants with observation of interest"
357073|NCT00375674|O2|Outcome|Placebo|"Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
Note: n = number of participants with observation of interest"
357074|NCT00375674|O1|Outcome|Sunitinib|"Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
Note: n = number of participants with observation of interest"
357075|NCT00375674|O2|Outcome|Placebo|"Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
n = Number of participants with any AEs of special interest (11)"
357076|NCT00375674|O1|Outcome|Sunitinib|"Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
n = Number of participants with any AEs of special interest (63) Note: One participant could have reported more than 1 AESI."
357077|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357078|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357079|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357132|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
357082|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357083|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357084|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357085|NCT00375674|E2|Reported Event|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357086|NCT00375674|E1|Reported Event|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
357087|NCT00375713|B3|Baseline|Total|Total of all reporting groups
357088|NCT00375713|B2|Baseline|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
357089|NCT00375713|B1|Baseline|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
357090|NCT00375713|P2|Participant Flow|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
357091|NCT00375713|P1|Participant Flow|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
357092|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
357093|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
357094|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
357095|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
357096|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
357097|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
357098|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
357099|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
357100|NCT00375713|E2|Reported Event|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
357101|NCT00375713|E1|Reported Event|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
357102|NCT00375752|B3|Baseline|Total|Total of all reporting groups
357103|NCT00375752|B2|Baseline|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
357104|NCT00375752|B1|Baseline|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
357105|NCT00375752|P2|Participant Flow|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
357106|NCT00375752|P1|Participant Flow|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
357107|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
357108|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
357109|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
357110|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
357111|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
357112|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
357113|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
357114|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
357115|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
359384|NCT00382993|O1|Outcome|Placebo|
357117|NCT00375752|E2|Reported Event|Letrozole Plus Zoledronic Acid|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
357118|NCT00375752|E1|Reported Event|Letrozole|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
357119|NCT00375934|B3|Baseline|Total|Total of all reporting groups
357120|NCT00375934|B2|Baseline|Placebo|Oral placebo capsule, every 6 hours
357121|NCT00375934|B1|Baseline|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357122|NCT00375934|P2|Participant Flow|Placebo|Oral placebo capsule, every 6 hours
357123|NCT00375934|P1|Participant Flow|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357124|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
357125|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357126|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
357127|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357128|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
357129|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357130|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
357135|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357136|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
357137|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357138|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
357139|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357140|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
357141|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357142|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
357143|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357144|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
357145|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357146|NCT00375934|E2|Reported Event|Placebo|Oral placebo capsule, every 6 hours
357147|NCT00375934|E1|Reported Event|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
357148|NCT00375973|B3|Baseline|Total|Total of all reporting groups
357149|NCT00375973|B2|Baseline|Placebo|"Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine"
357150|NCT00375973|B1|Baseline|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
357151|NCT00375973|P2|Participant Flow|Placebo|"Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine"
357152|NCT00375973|P1|Participant Flow|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
357153|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine"
357154|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
357155|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine"
357156|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
357157|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine"
357158|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
357159|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine"
357160|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
357161|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine"
357162|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
357163|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine"
357164|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
357165|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine"
357166|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
357167|NCT00375973|E2|Reported Event|Placebo|"Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine"
357168|NCT00375973|E1|Reported Event|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
357169|NCT00375999|B1|Baseline|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
357170|NCT00375999|P1|Participant Flow|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
357171|NCT00375999|O1|Outcome|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
357172|NCT00375999|E1|Reported Event|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
357173|NCT00376168|B3|Baseline|Total|Total of all reporting groups
357174|NCT00376168|B2|Baseline|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
357175|NCT00376168|B1|Baseline|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
357181|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
357182|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
357183|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
357184|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
357185|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
357186|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
357187|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
357188|NCT00376168|E2|Reported Event|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
357189|NCT00376168|E1|Reported Event|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
357190|NCT00376220|B3|Baseline|Total|Total of all reporting groups
357191|NCT00376220|B2|Baseline|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
357192|NCT00376220|B1|Baseline|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
357193|NCT00376220|P2|Participant Flow|Inactive/ Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
357194|NCT00376220|P1|Participant Flow|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take twice daily (BID). At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID [two capsules in the morning (qAM), two capsules in the evening (qHS)]. If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
357195|NCT00376220|O2|Outcome|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
357196|NCT00376220|O1|Outcome|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
357197|NCT00376220|E2|Reported Event|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
357198|NCT00376220|E1|Reported Event|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
357199|NCT00376259|B3|Baseline|Total|Total of all reporting groups
357200|NCT00376259|B2|Baseline|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
357201|NCT00376259|B1|Baseline|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
357202|NCT00376259|P2|Participant Flow|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
357203|NCT00376259|P1|Participant Flow|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
357204|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
357205|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
357206|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
357207|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
357208|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
357209|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
357210|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
357211|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
357212|NCT00376259|E2|Reported Event|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
357213|NCT00376259|E1|Reported Event|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
357215|NCT00376363|B2|Baseline|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control
Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
357216|NCT00376363|B1|Baseline|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control
Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
357217|NCT00376363|P2|Participant Flow|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control
Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
357218|NCT00376363|P1|Participant Flow|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control
Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
357219|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control
Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
357220|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control
Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
357221|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control
Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
357222|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control
Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
357223|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control
Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
357224|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control
Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
357225|NCT00376363|E2|Reported Event|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control
Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
357226|NCT00376363|E1|Reported Event|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control
Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
357227|NCT00376506|B3|Baseline|Total|Total of all reporting groups
357228|NCT00376506|B2|Baseline|Intramuscular|An implanted neurostimulator device used for swallowing retraining
357229|NCT00376506|B1|Baseline|Vibrotactile|An external vibrotactile device used for swallowing retraining
357230|NCT00376506|P2|Participant Flow|Intramuscular|An implanted neurostimulator device used for swallowing retraining
357231|NCT00376506|P1|Participant Flow|Vibrotactile|An external vibrotactile device used for swallowing retraining
357232|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing retraining. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
357233|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
357234|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
357235|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
357236|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
357237|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
357285|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
357286|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
357238|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing retraining. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
357239|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
357240|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.retraining
357241|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
357242|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
357243|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
361079|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
357244|NCT00376506|E2|Reported Event|Intramuscular|An implanted neurostimulator device used for swallowing retraining
357245|NCT00376506|E1|Reported Event|Vibrotactile|An external vibrotactile device used for swallowing retraining
357246|NCT00376532|B3|Baseline|Total|Total of all reporting groups
357247|NCT00376532|B2|Baseline|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
357248|NCT00376532|B1|Baseline|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
357249|NCT00376532|P2|Participant Flow|No ICD Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
357250|NCT00376532|P1|Participant Flow|ICD Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
357251|NCT00376532|O2|Outcome|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
357252|NCT00376532|O1|Outcome|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
357253|NCT00376532|O2|Outcome|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
357254|NCT00376532|O1|Outcome|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
357255|NCT00376532|E2|Reported Event|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
357256|NCT00376532|E1|Reported Event|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
357257|NCT00376558|B3|Baseline|Total|Total of all reporting groups
357258|NCT00376558|B2|Baseline|Control Subjects|Healthy controls who undergo scans
357259|NCT00376558|B1|Baseline|Cocaine Users|Cocaine users receiving CRA
357260|NCT00376558|P2|Participant Flow|Control Subjects|Healthy controls who undergo scans
357261|NCT00376558|P1|Participant Flow|Cocaine Users|Cocaine users receiving CRA
357262|NCT00376558|O1|Outcome|Cocaine Abuser Undergoing CM With CRA Treatment|Participants receive voucher points for each urine sample that tested negative for benzoylecgonine. Failure to submit a scheduled sample was treated as cocaine +. Voucher points have a monetary value that can be redeemed for goods/services that are approved by the therapist. Points ($0.25) were acquired on an escalating schedule that started at 10 points for the 1st cocaine-free sample, and each subsequent cocaine-free sample increased the value by 5 points. A bonus of 40 points ($10.00) for every 3 consecutive negative sample. Abstinence was confirmed by onsite urine test (Abuscreen On-Trak system, Roche Diagnostics). Missed clinic visits and urine samples that are considered + reset the points to the initial $2.50 value and the escalation schedule resume. Submission of 5 consecutive - samples after a + urine returns the voucher points to the value prior to reset. Points earned are never lost. A maximum of $997.50 is earned for submitting negative samples at all treatment visits.
357263|NCT00376558|O2|Outcome|Control Subjects|Healthy controls who undergo scans
357264|NCT00376558|O1|Outcome|Cocaine Users|Cocaine users receiving CRA
357265|NCT00376558|E2|Reported Event|Control Subjects|Healthy controls who undergo scans
357266|NCT00376558|E1|Reported Event|Cocaine Users|Cocaine users receiving CRA
357267|NCT00376675|B3|Baseline|Total|Total of all reporting groups
357268|NCT00376675|B2|Baseline|Placebo|Patients receive oral placebo daily on days 1-28.
357269|NCT00376675|B1|Baseline|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
357270|NCT00376675|P2|Participant Flow|Placebo|Patients receive oral placebo daily on days 1-28.
357271|NCT00376675|P1|Participant Flow|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
357272|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
357273|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
357274|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
357275|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
357276|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
357277|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
357278|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
357279|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
357280|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
357281|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
357291|NCT00376675|E1|Reported Event|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
357292|NCT00376688|B1|Baseline|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Temsirolimus: Given IV"
357293|NCT00376688|P1|Participant Flow|Temsirolimus|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Temsirolimus: Given IV"
357294|NCT00376688|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Temsirolimus: Given IV"
357295|NCT00376688|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Temsirolimus: Given IV"
357296|NCT00376805|B1|Baseline|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
357297|NCT00376805|P1|Participant Flow|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
357328|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357298|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
357299|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
357300|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
357301|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
357302|NCT00376805|E1|Reported Event|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
357303|NCT00376935|B5|Baseline|Total|Total of all reporting groups
357304|NCT00376935|B4|Baseline|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357305|NCT00376935|B3|Baseline|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357306|NCT00376935|B2|Baseline|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357307|NCT00376935|B1|Baseline|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357308|NCT00376935|P4|Participant Flow|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357309|NCT00376935|P3|Participant Flow|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357310|NCT00376935|P2|Participant Flow|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357311|NCT00376935|P1|Participant Flow|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357312|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357313|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357314|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357315|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357316|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357317|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357318|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357319|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357320|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357431|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357321|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357322|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357323|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357324|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357325|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357326|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357327|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357329|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357330|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357331|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357332|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357333|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357334|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357335|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357336|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357337|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357338|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357339|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357340|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357341|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357342|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357343|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357344|NCT00376935|E4|Reported Event|Palifermin (60 Mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357345|NCT00376935|E3|Reported Event|Palifermin (40 Mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357346|NCT00376935|E2|Reported Event|Palifermin (20 Mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357347|NCT00376935|E1|Reported Event|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
357348|NCT00376948|B1|Baseline|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28
genistein
erlotinib hydrochloride
gemcitabine hydrochloride"
357349|NCT00376948|P1|Participant Flow|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28
genistein
erlotinib hydrochloride
gemcitabine hydrochloride"
357350|NCT00376948|O1|Outcome|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28
genistein
erlotinib hydrochloride
gemcitabine hydrochloride"
361026|NCT00386334|O1|Outcome|Placebo|Placebo tablets
357351|NCT00376948|O1|Outcome|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28
genistein
erlotinib hydrochloride
gemcitabine hydrochloride"
357352|NCT00376948|E1|Reported Event|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28
genistein
erlotinib hydrochloride
gemcitabine hydrochloride"
357353|NCT00376961|B1|Baseline|Rituximab-CHOP-Bortezomib (R-CHOP-V)|R-CHOP-V will be administered for 6 cycles (one cycle is defined as a single 21-day course of treatment).
357354|NCT00376961|P2|Participant Flow|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
357355|NCT00376961|P1|Participant Flow|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle = 21 days)
357356|NCT00376961|O2|Outcome|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
357357|NCT00376961|O1|Outcome|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle = 21 days)
357384|NCT00377234|P1|Participant Flow|Sequence A|Ibandronate followed by risedronate
357385|NCT00377234|O2|Outcome|Sequence B|risedronate followed by ibandronate
357358|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 dyas). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
357359|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 days). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
357360|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 days). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
357361|NCT00376961|E2|Reported Event|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
357362|NCT00376961|E1|Reported Event|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle= 21 days)
357363|NCT00377156|B3|Baseline|Total|Total of all reporting groups
357364|NCT00377156|B2|Baseline|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >
> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
357365|NCT00377156|B1|Baseline|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
357366|NCT00377156|P2|Participant Flow|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >
> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
357367|NCT00377156|P1|Participant Flow|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
357368|NCT00377156|O2|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >>
>> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
357369|NCT00377156|O1|Outcome|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
357370|NCT00377156|O2|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >
> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
357371|NCT00377156|O1|Outcome|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
357372|NCT00377156|O2|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >
> >
> > Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
357373|NCT00377156|O1|Outcome|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
357374|NCT00377156|O2|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >
> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
357432|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357375|NCT00377156|O1|Outcome|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
357376|NCT00377156|O2|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >
> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
357377|NCT00377156|O1|Outcome|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
357378|NCT00377156|E2|Reported Event|Arm II (SRS+WBRT)|Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.
357379|NCT00377156|E1|Reported Event|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
357380|NCT00377234|B3|Baseline|Total|Total of all reporting groups
357381|NCT00377234|B2|Baseline|Sequence B|Risedronate followed by ibandronate
357382|NCT00377234|B1|Baseline|Sequence A|Ibandronate followed by risedronate
357383|NCT00377234|P2|Participant Flow|Sequence B|Risedronate followed by ibandronate
357386|NCT00377234|O1|Outcome|Sequence A|ibandronate followed by risedronate
357387|NCT00377234|O2|Outcome|Sequence B|risedronate followed by ibandronate
357388|NCT00377234|O1|Outcome|Sequence A|ibandronate followed by risedronate
357389|NCT00377234|O2|Outcome|Risedronate|While being treated with risendronate
357390|NCT00377234|O1|Outcome|Ibandronate|While being treated with ibandronate
357391|NCT00377234|O3|Outcome|Total|During period 1 + during period 2
357392|NCT00377234|O2|Outcome|During Sequence B|Risedronate followed by ibandronate
357393|NCT00377234|O1|Outcome|During Sequence A|Ibandronate followed by risedronate
357394|NCT00377234|O3|Outcome|Total|During period 1 + during period 2
357395|NCT00377234|O2|Outcome|During Sequence B|Risendronate followed by ibandronate
357396|NCT00377234|O1|Outcome|During Sequence A|Ibandronate followed by risedronate
357397|NCT00377234|E2|Reported Event|Risedronate|Risendronate adverse events
357398|NCT00377234|E1|Reported Event|Ibandronate|Ibandronate adverse events
357399|NCT00377260|B3|Baseline|Total|Total of all reporting groups
357400|NCT00377260|B2|Baseline|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357401|NCT00377260|B1|Baseline|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357402|NCT00377260|P2|Participant Flow|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357403|NCT00377260|P1|Participant Flow|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357404|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357405|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357406|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357407|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357408|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357409|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357410|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357411|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357412|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357413|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357414|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357415|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357416|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357417|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357418|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357419|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357420|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357421|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357422|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357423|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357424|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357425|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357426|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357427|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357428|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357429|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357433|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357434|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357435|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357436|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357437|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357438|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357439|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357440|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357441|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357442|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357443|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357444|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357445|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357446|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357509|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
357447|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357448|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357449|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357450|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357451|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357452|NCT00377260|E2|Reported Event|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
357453|NCT00377260|E1|Reported Event|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
357454|NCT00377299|B3|Baseline|Total|Total of all reporting groups
357455|NCT00377299|B2|Baseline|Placebo|
357456|NCT00377299|B1|Baseline|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
357457|NCT00377299|P2|Participant Flow|Placebo|Placebo identical in appearance to the medication was given beginning at one tablet with an increase to two tablets at week 2, three tablets at week 4 and four tablets at week 6. Patients remained on four tables throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects.
357458|NCT00377299|P1|Participant Flow|Citicoline|Citicoline add-on therapy was given beginning at one tablet(500mg/day) with an increase to two tablets(1000mg/day) at week 2, three tablets(1500mg/day)at week 4 and four tablets (2000mg/day) at week 6. Patients remained on 2000mg/day throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects.
357459|NCT00377299|O2|Outcome|Placebo|Placebo.
357460|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
357461|NCT00377299|O2|Outcome|Placebo|Placebo matching Citicoline.
357462|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
357463|NCT00377299|O2|Outcome|Placebo|Placebo matching Citicoline.
357464|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
357465|NCT00377299|O2|Outcome|Placebo|Placebo.
357466|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
357467|NCT00377299|O2|Outcome|Placebo|Placebo.
357468|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
357469|NCT00377299|E2|Reported Event|Placebo|
357470|NCT00377299|E1|Reported Event|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
357471|NCT00377312|B3|Baseline|Total|Total of all reporting groups
357472|NCT00377312|B2|Baseline|Parathyroid Hormone(1-34) - 4 Picomoles/kg/hr|Subjects received Parathyroid Hormone (1-34)intravenously at 4 picomoles/kg/hr.
357473|NCT00377312|B1|Baseline|Parathyroid Hormone - 2 Picomoles/kg/hr.|Subjects initially entering the study receive study drug Parathyroid Hormone (1-34) in intravenous doses beginning at 2 picomoles/kg/hr. Doses will be slowly and safely escalated in groups of 3 subjects.
357474|NCT00377312|P2|Participant Flow|Group 2|PTH (1-34) 4 picomoles (pmols)/kg/hr
357475|NCT00377312|P1|Participant Flow|Group 1|PTH (1-34) 2 picomoles (pmols)/kg/hr
357476|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357477|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357478|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357479|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357480|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357481|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357482|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357483|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357484|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357485|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357486|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357487|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357488|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357490|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357491|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357492|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357493|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357494|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357495|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357496|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357497|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357498|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357499|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357500|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
357501|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
357502|NCT00377312|E2|Reported Event|Group 2|PTH (1-34) 4 picomoles (pmols)/kg/hr
357503|NCT00377312|E1|Reported Event|Group 1|PTH (1-34) 2 picomoles (pmols)/kg/hr
357504|NCT00377364|B3|Baseline|Total|Total of all reporting groups
357505|NCT00377364|B2|Baseline|Placebo|Matching Placebo.
357506|NCT00377364|B1|Baseline|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
357507|NCT00377364|P2|Participant Flow|Placebo|Matching Placebo.
357508|NCT00377364|P1|Participant Flow|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
357510|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
357511|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
357512|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
357513|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
357514|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
357515|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
357516|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
357517|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
357518|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
357519|NCT00377364|O2|Outcome|Placebo|Matching placebo.
357520|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
357521|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
357522|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
357523|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
357524|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
357525|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
357526|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
357527|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
357528|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
357529|NCT00377364|E2|Reported Event|Placebo|Matching Placebo.
357530|NCT00377364|E1|Reported Event|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
357531|NCT00377403|B3|Baseline|Total|Total of all reporting groups
357532|NCT00377403|B2|Baseline|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
357533|NCT00377403|B1|Baseline|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
357534|NCT00377403|P2|Participant Flow|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
357535|NCT00377403|P1|Participant Flow|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
357536|NCT00377403|O2|Outcome|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
357537|NCT00377403|O1|Outcome|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
357538|NCT00377403|E2|Reported Event|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
357539|NCT00377403|E1|Reported Event|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
357540|NCT00377429|B1|Baseline|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
357541|NCT00377429|P1|Participant Flow|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
357542|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
357543|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
357544|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
357545|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
357546|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
357547|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
357548|NCT00377429|E1|Reported Event|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
357549|NCT00377455|B1|Baseline|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
357550|NCT00377455|P1|Participant Flow|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
357551|NCT00377455|O1|Outcome|Bosentan/Placebo|Outcomes not available, due to early termination of study
357552|NCT00377455|E1|Reported Event|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
357553|NCT00377520|B1|Baseline|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
357554|NCT00377520|P1|Participant Flow|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
357555|NCT00377520|O1|Outcome|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
357556|NCT00377520|O1|Outcome|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
357557|NCT00377520|E1|Reported Event|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
357558|NCT00377572|B3|Baseline|Total|Total of all reporting groups
357559|NCT00377572|B2|Baseline|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357560|NCT00377572|B1|Baseline|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357561|NCT00377572|P2|Participant Flow|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357562|NCT00377572|P1|Participant Flow|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357563|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357564|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357565|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357566|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357567|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357568|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357569|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357570|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357571|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357699|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
357572|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357573|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357574|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357603|NCT00377637|B1|Baseline|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
358739|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
357575|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357576|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357577|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357578|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357579|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357580|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357581|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357582|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357583|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357584|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357626|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
357627|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
357585|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357586|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357587|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357588|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357589|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357590|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357591|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357592|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357593|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357594|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357595|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357596|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357597|NCT00377572|E2|Reported Event|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357628|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
357629|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
357598|NCT00377572|E1|Reported Event|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
357599|NCT00377637|B5|Baseline|Total|Total of all reporting groups
357600|NCT00377637|B4|Baseline|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
357601|NCT00377637|B3|Baseline|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
357602|NCT00377637|B2|Baseline|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
357657|NCT00377741|B1|Baseline|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
357604|NCT00377637|P4|Participant Flow|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
357605|NCT00377637|P3|Participant Flow|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
357606|NCT00377637|P2|Participant Flow|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
357607|NCT00377637|P1|Participant Flow|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
357608|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
357609|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
357610|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
357611|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
357612|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
357613|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
357614|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
357615|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
357616|NCT00377637|O2|Outcome|Azathioprine (AZA)|Azathioprine (AZA) 2.0 mg/kg/day along with placebo matching MMF (1.0 g BID), plus corticosteroid for 36 months of therapy
357617|NCT00377637|O1|Outcome|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil (MMF) 1.0 g twice daily (BID) along with placebo matching AZA (2.0 mg/kg/day), plus corticosteroid, until 36 months of therapy.
357618|NCT00377637|O2|Outcome|Azathioprine (AZA)|Azathioprine (AZA) 2 mg/kg/day orally once a day + Placebo to MMF orally twice a day + Corticosteroid for 36 months.
357619|NCT00377637|O1|Outcome|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil (MMF) 1.0 g orally twice a day + Placebo to Azathioprine orally once a day + Corticosteroid for 36 months
357620|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
357621|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
357622|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
357623|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
357624|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
357625|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
357698|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
357630|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
357631|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
357632|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
357633|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
357634|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
357635|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
357658|NCT00377741|P2|Participant Flow|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
361080|NCT00386334|O1|Outcome|Placebo|Placebo tablets
357636|NCT00377637|E4|Reported Event|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
357637|NCT00377637|E3|Reported Event|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
357638|NCT00377637|E2|Reported Event|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
357639|NCT00377637|E1|Reported Event|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
357640|NCT00377676|B3|Baseline|Total|Total of all reporting groups
357641|NCT00377676|B2|Baseline|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357642|NCT00377676|B1|Baseline|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357643|NCT00377676|P2|Participant Flow|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357644|NCT00377676|P1|Participant Flow|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357645|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357646|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357647|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357648|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357649|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357650|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357651|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
361027|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
357652|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357653|NCT00377676|E2|Reported Event|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357654|NCT00377676|E1|Reported Event|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
357655|NCT00377741|B3|Baseline|Total|Total of all reporting groups
357656|NCT00377741|B2|Baseline|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
357659|NCT00377741|P1|Participant Flow|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
357660|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
357661|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
357662|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
357663|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
357664|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
357665|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
357666|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
357667|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
357668|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
357669|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
357670|NCT00377741|E2|Reported Event|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
357671|NCT00377741|E1|Reported Event|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
357672|NCT00377819|B3|Baseline|Total|Total of all reporting groups
357673|NCT00377819|B2|Baseline|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
357674|NCT00377819|B1|Baseline|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
357675|NCT00377819|P2|Participant Flow|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
357676|NCT00377819|P1|Participant Flow|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
357677|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
357678|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
357679|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
357680|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
357681|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
357682|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
357683|NCT00377819|E2|Reported Event|Denosumab 60 mg Q6M|
357684|NCT00377819|E1|Reported Event|Alendronate 70 mg QW|
357685|NCT00377832|B3|Baseline|Total|Total of all reporting groups
357686|NCT00377832|B2|Baseline|Acetaminophen 975 mg Once|
357687|NCT00377832|B1|Baseline|No Medication|
357688|NCT00377832|P2|Participant Flow|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
357689|NCT00377832|P1|Participant Flow|In Labor With a Fever Will Give no Medication|
357690|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
357691|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
357692|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
357693|NCT00377832|O1|Outcome|In Labor With a Fever Will Get no Medication|
357694|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
357695|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
357696|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
357697|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
361028|NCT00386334|O1|Outcome|Placebo|Placebo tablets
357700|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
357701|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
357702|NCT00377832|O2|Outcome|Acetaminophen 975 mg Once|
357703|NCT00377832|O1|Outcome|No Medication|
357704|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
357705|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
357706|NCT00377832|E2|Reported Event|Acetaminophen 975 mg Once|In labor, fever is identified, consent and randomization occurs, then acetaminophen is given.
357707|NCT00377832|E1|Reported Event|No Medication|In labor, fever is identified, consent and randomization occurs, then no medication is given.
357708|NCT00377858|B3|Baseline|Total|Total of all reporting groups
357709|NCT00377858|B2|Baseline|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357710|NCT00377858|B1|Baseline|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357711|NCT00377858|P2|Participant Flow|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357712|NCT00377858|P1|Participant Flow|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357713|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357714|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357715|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357716|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357717|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357718|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357719|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357720|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357721|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357722|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357723|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357724|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357725|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357726|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357727|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357728|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357729|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357730|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357731|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357732|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357733|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357734|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357735|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357736|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357737|NCT00377858|E2|Reported Event|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
357738|NCT00377858|E1|Reported Event|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
357739|NCT00377962|B3|Baseline|Total|Total of all reporting groups
357740|NCT00377962|B2|Baseline|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357741|NCT00377962|B1|Baseline|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357742|NCT00377962|P2|Participant Flow|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357743|NCT00377962|P1|Participant Flow|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357744|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
358094|NCT00379288|E4|Reported Event|F/SC MDI 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
357745|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357746|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357747|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357748|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357790|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
361081|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
357749|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357750|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357751|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357752|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357753|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357754|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357755|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357756|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357757|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357758|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357759|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357760|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357761|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357762|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357924|NCT00378378|O2|Outcome|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
357763|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357764|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357765|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357766|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
357767|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
357768|NCT00377962|E8|Reported Event|Everolimus + CNI Reduction: 24 Month Lung|"Subgroup of everolimus + CNI reduction group with lung patients at 24 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
357769|NCT00377962|E7|Reported Event|Control: 24 Month Lung|"Subgroup of Control group with lung patients at 24 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
357770|NCT00377962|E6|Reported Event|Everolimus + CNI Reduction: 24 Month Heart|"Subgroup of everolimus + CNI reduction group with heart patients at 24 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
357771|NCT00377962|E5|Reported Event|Control: 24 Month Heart|"Subgroup of Control group with heart patients at 24 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
357772|NCT00377962|E4|Reported Event|Everolimus+CNI Reduction: 12 Month Lung|"Subgroup of everolimus + CNI reduction group with lung patients at 12 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
357773|NCT00377962|E3|Reported Event|Control: 12 Month Lung|"Subgroup of control group with lung patients at 12 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
357774|NCT00377962|E2|Reported Event|Everolimus + CNI Reduction: 12 Month Heart|"Subgroup of everolimus + CNI reduction group with heart patients at 12 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
357775|NCT00377962|E1|Reported Event|Control: 12 Month Heart|"Subgroup of Control group with heart patients at 12 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
357776|NCT00378014|B3|Baseline|Total|Total of all reporting groups
357777|NCT00378014|B2|Baseline|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357778|NCT00378014|B1|Baseline|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357779|NCT00378014|P2|Participant Flow|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357780|NCT00378014|P1|Participant Flow|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357781|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357782|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357783|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357784|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357785|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357786|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357787|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357788|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357789|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357791|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357792|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357793|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357794|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357795|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357796|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357797|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357798|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357799|NCT00378014|E4|Reported Event|Extension Period - CNI|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357800|NCT00378014|E3|Reported Event|Extension Period - Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357801|NCT00378014|E2|Reported Event|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
357802|NCT00378014|E1|Reported Event|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
357803|NCT00378079|B4|Baseline|Total|Total of all reporting groups
357804|NCT00378079|B3|Baseline|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
357805|NCT00378079|B2|Baseline|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
357806|NCT00378079|B1|Baseline|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
357807|NCT00378079|P3|Participant Flow|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
357808|NCT00378079|P2|Participant Flow|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
357809|NCT00378079|P1|Participant Flow|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
357810|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
357811|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
357812|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
357813|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
357814|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
357815|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
357816|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
358034|NCT00379236|B3|Baseline|Total|Total of all reporting groups
357817|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
357818|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
357819|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
357820|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
357821|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
357822|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
357823|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
357824|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
357931|NCT00378378|E1|Reported Event|MFNS 100 or 200 mcg QD|
357932|NCT00378703|B5|Baseline|Total|Total of all reporting groups
357825|NCT00378079|E3|Reported Event|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
357826|NCT00378079|E2|Reported Event|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
357827|NCT00378079|E1|Reported Event|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
357828|NCT00378105|B3|Baseline|Total|Total of all reporting groups
357829|NCT00378105|B2|Baseline|Phase 2 Population|
357830|NCT00378105|B1|Baseline|Phase 1 Population|
357831|NCT00378105|P2|Participant Flow|Phase 2 Pupulation|Each subject received the maximum planned dose of 1.3 mg/m2/IV bortezomib daily Days 1, 4, 8 and 11 followed by a 10-day rest period, 20 mg PO dexamethasone single daily oral dose Days 1, 2, 4, 5, 8, 9, 11, 12 and25 mg/PO/QD (every day)lenalidomide daily Days 1-14 followed by 7-day rest every 21 days x 4 cycles and then at 10 mg/day on the same schedule for cycles 5 – 8. Each cycle of treatment consisted of 21 days.
357832|NCT00378105|P1|Participant Flow|Phase 1 Population|"Four levels of dose were evaluated and a standard 3+3 dose escalation schema was used to determine the MTD and additional patients were evaluated on the MTD level.
Level 1 1 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days
Level 2 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days
Level 3 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 20 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days
Level 4 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 25 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days"
357833|NCT00378105|O1|Outcome|All Patients|
357834|NCT00378105|O1|Outcome|All Patients|
357835|NCT00378105|O1|Outcome|All Patients|
357836|NCT00378105|O3|Outcome|Total|
357837|NCT00378105|O2|Outcome|Phase II Population|
357838|NCT00378105|O1|Outcome|Phase 1 Population|
357839|NCT00378105|E1|Reported Event|All Patients|
357840|NCT00372567|B4|Baseline|Total|Total of all reporting groups
357841|NCT00372567|B3|Baseline|Sunitinib (Phase 1)|Single 37.5 mg dose administered 24 hours after the last dose of imatinib
357842|NCT00372567|B2|Baseline|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357843|NCT00372567|B1|Baseline|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357844|NCT00372567|P3|Participant Flow|Sunitinib (Phase 1)|Single 37.5 mg dose administered 24 hours after the last dose of imatinib
357845|NCT00372567|P2|Participant Flow|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357846|NCT00372567|P1|Participant Flow|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357847|NCT00372567|O1|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357848|NCT00372567|O1|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357849|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357850|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357851|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357852|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357853|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357854|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357855|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357856|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357857|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357858|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357859|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357860|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357861|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357862|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357863|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357864|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357865|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357866|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357867|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357868|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357869|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
357870|NCT00372567|O1|Outcome|Sunitinib|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
357871|NCT00372567|E2|Reported Event|Imatinib|All participants who received Imatinib
357872|NCT00372567|E1|Reported Event|All Participants Who Received Sunitinib|Participants in Phase 1 sub- study and Phase 3 study
357873|NCT00378209|B1|Baseline|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.
Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
357874|NCT00378209|P1|Participant Flow|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.
Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
357875|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|
357876|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.
Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
357877|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.
Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
357922|NCT00378378|P1|Participant Flow|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
357923|NCT00378378|O3|Outcome|Pooled Placebo|All placebo groups were combined
357878|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.
Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
357933|NCT00378703|B4|Baseline|Arm D (Sorafenib and Temsirolimus)|Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
357934|NCT00378703|B3|Baseline|Arm C (Bevacizumab and Sorafenib)|Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
357935|NCT00378703|B2|Baseline|Arm B (Bevacizumab and Temsirolimus)|Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
357936|NCT00378703|B1|Baseline|Arm A (Bevacizumab)|Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
357879|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.
Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
357880|NCT00378209|E1|Reported Event|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.
Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
357881|NCT00378326|B1|Baseline|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
357882|NCT00378326|P1|Participant Flow|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
357883|NCT00378326|O1|Outcome|Tacrolimus|Tacrolimus at doses of 0.15-0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
357884|NCT00378326|O2|Outcome|Post-treatment|White blood cell (WBC) count in CSF post-treatment
357885|NCT00378326|O1|Outcome|Pre-treatment|White blood cell (WBC) count in CSF pre-treatment
357886|NCT00378326|E1|Reported Event|All Patients|All patients enrolled
357887|NCT00378352|B3|Baseline|Total|Total of all reporting groups
357888|NCT00378352|B2|Baseline|Placebo|Dose escalation and efficacy phases
357889|NCT00378352|B1|Baseline|Epoetin Alfa|Dose escalation and efficacy phases
357890|NCT00378352|P6|Participant Flow|Efficacy Phase Placebo|Single dose placebo
357891|NCT00378352|P5|Participant Flow|Efficacy Phase 60,000 Units Epoetin Alfa|Prospective, randomized, double-blind, placebo-controlled trial Single dose 60000 U of epoetin alfa
357892|NCT00378352|P4|Participant Flow|Dose Escalation Placebo|
357893|NCT00378352|P3|Participant Flow|Dose Escalation 60,000 Units Epoetin Alfa|
357894|NCT00378352|P2|Participant Flow|Dose Escalation 30,000 Units Epoetin Alfa|
357895|NCT00378352|P1|Participant Flow|Dose Escalation 15,000 Units Epoetin Alfa|
357896|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
357897|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
357898|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
357899|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
357900|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
357901|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
357902|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
357903|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
357904|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
357905|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
357906|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
357907|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
357908|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
357909|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
357910|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
357911|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
357912|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
357913|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
357914|NCT00378352|E2|Reported Event|Placebo|Patients who received placebo
357915|NCT00378352|E1|Reported Event|Epoetin Alfa|Patients who received active study medication
357916|NCT00378378|B4|Baseline|Total|Total of all reporting groups
357917|NCT00378378|B3|Baseline|Pooled Placebo|All placebo groups were combined
357918|NCT00378378|B2|Baseline|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
357919|NCT00378378|B1|Baseline|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
357920|NCT00378378|P3|Participant Flow|Pooled Placebo|All placebo groups were combined
357921|NCT00378378|P2|Participant Flow|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
357925|NCT00378378|O1|Outcome|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
357926|NCT00378378|O3|Outcome|Pooled Placebo|All placebo groups were combined
357927|NCT00378378|O2|Outcome|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
357928|NCT00378378|O1|Outcome|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
357929|NCT00378378|E3|Reported Event|Placebo|
357930|NCT00378378|E2|Reported Event|MFNS 100 or 200 mcg BID|
357937|NCT00378703|P4|Participant Flow|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
Sorafenib: Given PO
temsirolimus: Given IV"
357938|NCT00378703|P3|Participant Flow|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
Sorafenib: Given PO
bevacizumab: Given IV"
357939|NCT00378703|P2|Participant Flow|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
temsirolimus: Given IV
bevacizumab: Given IV"
357940|NCT00378703|P1|Participant Flow|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
bevacizumab: Given IV"
357941|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
Sorafenib: Given PO
temsirolimus: Given IV"
357942|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
Sorafenib: Given PO
bevacizumab: Given IV"
357943|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
temsirolimus: Given IV
bevacizumab: Given IV"
357944|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
bevacizumab: Given IV"
357945|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
Sorafenib: Given PO
temsirolimus: Given IV"
357946|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
Sorafenib: Given PO
bevacizumab: Given IV"
357947|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
temsirolimus: Given IV
bevacizumab: Given IV"
357948|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
bevacizumab: Given IV"
357949|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
Sorafenib: Given PO
temsirolimus: Given IV"
357950|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
Sorafenib: Given PO
bevacizumab: Given IV"
357951|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
temsirolimus: Given IV
bevacizumab: Given IV"
357952|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
bevacizumab: Given IV"
357953|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
Sorafenib: Given PO
temsirolimus: Given IV"
357954|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
Sorafenib: Given PO
bevacizumab: Given IV"
357955|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
temsirolimus: Given IV
bevacizumab: Given IV"
357956|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
bevacizumab: Given IV"
357957|NCT00378703|E4|Reported Event|Arm D (Sorafenib and Temsirolimus)|Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
357958|NCT00378703|E3|Reported Event|Arm C (Bevacizumab and Sorafenib)|Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
357959|NCT00378703|E2|Reported Event|Arm B (Bevacizumab and Temsirolimus)|Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
357960|NCT00378703|E1|Reported Event|Arm A (Bevacizumab)|Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
357961|NCT00378898|B3|Baseline|Total|Total of all reporting groups
361029|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
357962|NCT00378898|B2|Baseline|EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
357963|NCT00378898|B1|Baseline|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement
Fluoroscopy: one time xray to determine evacuation of bravo"
357964|NCT00378898|P2|Participant Flow|EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
357965|NCT00378898|P1|Participant Flow|EGD With BRAVO Capsule|"Bravo PH capsule:egd with bravo placement
Fluoroscopy: one time xray to determine evacuation of bravo"
357966|NCT00378898|O2|Outcome|EGD With Sham BRAVO Capsule Placement|"Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
sham BRAVO capsule placement"
357967|NCT00378898|O1|Outcome|EGD With Proximal BRAVO Capsule|"Subjects have a second BRAVO capsule placed 10cm proximal to prior BRAVO capsule placement. Fluoroscopy is used to confirm detachment of the monitor 7 days after investigational deployment.
BRAVO capsule
Fluoroscopy: one time xray to determine evacuation of bravo"
357968|NCT00378898|O2|Outcome|Sham Comparator: EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
357969|NCT00378898|O1|Outcome|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement
Fluoroscopy: one time xray to determine evacuation of bravo"
361082|NCT00386334|O1|Outcome|Placebo|Placebo tablets
357970|NCT00378898|E2|Reported Event|EGS With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed. Analysis is for participants who completed the study.
357971|NCT00378898|E1|Reported Event|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement. Analysis is for participants who completed the study.
Fluoroscopy: one time xray to determine evacuation of bravo"
357972|NCT00379080|B4|Baseline|Total|Total of all reporting groups
357973|NCT00379080|B3|Baseline|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.
600mg was the determined MTD in Dose Escalation
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
357974|NCT00379080|B2|Baseline|Arm 2 - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
tandutinib: Given orally
pharmacological study: Correlative studies"
357975|NCT00379080|B1|Baseline|Arm 1 - Phase 0|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
conventional surgery
oral tandutinib
Pharmacological study
Tissue samples"
357976|NCT00379080|P3|Participant Flow|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.
600mg was the determined MTD in Dose Escalation
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
357977|NCT00379080|P2|Participant Flow|Arm 2 - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
tandutinib: Given orally
pharmacological study: Correlative studies"
357978|NCT00379080|P1|Participant Flow|Arm 1- Phase 0|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
conventional surgery
oral tandutinib
Pharmacological study
Tissue samples"
357979|NCT00379080|O10|Outcome|Association Between PFS Biomarker Day 28 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation
oral tandutinib
tandutinib: Given orally
pharmacological study: Correlative studies
Peripheral blood"
357980|NCT00379080|O9|Outcome|Association Between OS and Biomarker Day 28 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation
oral tandutinib
tandutinib: Given orally
pharmacological study: Correlative studies
Peripheral blood"
357981|NCT00379080|O8|Outcome|Association Between PFS Biomarker Day 10 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation
oral tandutinib
tandutinib: Given orally
pharmacological study: Correlative studies
Peripheral blood"
357982|NCT00379080|O7|Outcome|Association Between OS and Biomarker Day 10 /BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation
oral tandutinib
tandutinib: Given orally
pharmacological study: Correlative studies
Peripheral blood"
357983|NCT00379080|O6|Outcome|Association Between PFS Biomarker Day 8 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation
oral tandutinib
tandutinib: Given orally
pharmacological study: Correlative studies
Peripheral blood"
357984|NCT00379080|O5|Outcome|Association Between OS and Biomarker Day 8 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation
oral tandutinib
tandutinib: Given orally
pharmacological study: Correlative studies
Peripheral blood"
357985|NCT00379080|O4|Outcome|Association Between PFS Biomarker Day 2 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation
oral tandutinib
tandutinib: Given orally
pharmacological study: Correlative studies
Peripheral blood"
357986|NCT00379080|O3|Outcome|Association Between OS and Biomarker Day 2 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation
oral tandutinib
tandutinib: Given orally
pharmacological study: Correlative studies
Peripheral blood"
357987|NCT00379080|O2|Outcome|Baseline (BL) - Progression Free Survival (PFS)|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation
oral tandutinib
tandutinib: Given orally
pharmacological study: Correlative studies
Peripheral blood"
357988|NCT00379080|O1|Outcome|Baseline (BL) - Overall Survival (OS)|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation
oral tandutinib
tandutinib: Given orally
pharmacological study: Correlative studies
Peripheral blood"
357989|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.
600mg was the determined MTD in Dose Escalation
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
357990|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.
600mg was the determined MTD in Dose Escalation
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
357991|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.
600mg was the determined MTD in Dose Escalation
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
357992|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.
600mg was the determined MTD in Dose Escalation
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
357993|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 700mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358611|NCT00379912|O2|Outcome|Arm B Azacitidine|"Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
357994|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.
600mg was the determined MTD in Dose Escalation
dose for tandtinib is 600mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
357995|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 500mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
357996|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 700mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
357997|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.
600mg was the determined MTD in Dose Escalation
dose for tandtinib is 600mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
357998|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 500mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
357999|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 700mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358000|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.
600mg was the determined MTD in Dose Escalation
dose for tandtinib is 600mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358001|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 500mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358089|NCT00379288|P1|Participant Flow|MF/F 200/10 mcg BID|mometasone furoate/formoterol (MF/F) 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
358002|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 700mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358003|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.
600mg was the determined MTD in Dose Escalation
dose for tandtinib is 600mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358102|NCT00379340|B2|Baseline|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
358004|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 500mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358005|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 700mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358006|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.
600mg was the determined MTD in Dose Escalation
dose for tandtinib is 600mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358007|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 500mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358008|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 700mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358009|NCT00379080|O2|Outcome|Level 2 - 600mg BID (Phase 1 & Phase 2)|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.
600mg was the determined MTD in Dose Escalation
dose for tandtinib is 600mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358010|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 500mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358011|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.
600mg was the determined MTD in Dose Escalation
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358012|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 700mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358090|NCT00379288|O4|Outcome|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
358091|NCT00379288|O3|Outcome|F/SC 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
358013|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 600mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358014|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
dose for tandtinib is 500mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358152|NCT00379353|E1|Reported Event|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
358015|NCT00379080|O1|Outcome|Arm I - Feasibility|"Participants receive oral tandutinib 500 mg twice daily for 7 days prior to surgery. Patients then undergo biopsy or surgery to remove the tumor. Tissue collected for tumor/plasma ratio.
Post surgery, within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. (not necessary for feasibility)
conventional surgery
oral tandutinib
Pharmacological study
Tissue samples
conventional surgery: Undergo surgery
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358016|NCT00379080|O1|Outcome|Reporting Group - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. All dose Levels
tandutinib: Given orally
pharmacological study: Correlative studies"
358017|NCT00379080|E3|Reported Event|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.
600mg was the determined MTD in Dose Escalation
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358018|NCT00379080|E2|Reported Event|Arm 2 - Dose Escalation (Phase 1)|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
the starting dose for tandtinib is 500mg BID
oral tandutinib
Pharmacological study
Tissue samples
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358019|NCT00379080|E1|Reported Event|Arm I - Feasibility|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
conventional surgery
oral tandutinib
Pharmacological study
Tissue samples
conventional surgery: Undergo surgery
tandutinib: Given orally
pharmacological study: Correlative studies
Tissue samples: Correlative studies"
358020|NCT00379197|B1|Baseline|Naltrexone|"Naltrexone hydrochloride 50 mg will be taken once a day every day of a 28 day treatment course. Positron-emission tomography (PET) / computed tomography (CT) given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG).
naltrexone hydrochloride: Naltrexone should be taken with water or food, and it can be taken at any time day. Naltrexone 50 mg will be taken once a day every day of a 28 day treatment course.
Positron-emission tomography (PET) / computed tomography (CT): Given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). Follow-up scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up."
358021|NCT00379197|P1|Participant Flow|Naltrexone|Naltrexone 50 mg taken orally once daily for 2 28-day cycles with an option to continue on Naltrexone at the discretion of the treating physician.
358022|NCT00379197|O1|Outcome|Naltrexone|"Naltrexone 50 mg will be taken orally once a day every day of a 28 day treatment course (cycle 1) and continue for another identical 28 day treatment (cycle 2) . PET scan will be performed after cycle 1 and cycle 2 complete.
naltrexone: Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval.
PET scan: Patients will receive PET scan approximately one hour after being injected with 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). PET scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up."
358023|NCT00379197|O1|Outcome|Naltrexone Treatment|Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed as baseline level at the beginning of study and after the completion of cycle 1 and cycle 2.
358024|NCT00379197|E1|Reported Event|Naltrexone Treatment|Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up compared to the baseline level of FDG uptake.
358025|NCT00379210|B3|Baseline|Total|Total of all reporting groups
358026|NCT00379210|B2|Baseline|Nutrition Education Group|Nutrition education group - received information about nutrition
358027|NCT00379210|B1|Baseline|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
358028|NCT00379210|P2|Participant Flow|Nutrition Education Group|Nutrition education group - received information about nutrition
358029|NCT00379210|P1|Participant Flow|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
358030|NCT00379210|O2|Outcome|Nutrition Education Group|Nutrition education group - received information about nutrition
358031|NCT00379210|O1|Outcome|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
358032|NCT00379210|E2|Reported Event|Nutrition Education Group|Nutrition education group - received information about nutrition
358033|NCT00379210|E1|Reported Event|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
358035|NCT00379236|B2|Baseline|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358036|NCT00379236|B1|Baseline|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358037|NCT00379236|P3|Participant Flow|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
358038|NCT00379236|P2|Participant Flow|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358153|NCT00379574|B1|Baseline|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
358039|NCT00379236|P1|Participant Flow|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358040|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
358041|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
358042|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
358043|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
358044|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358045|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358046|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358047|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358048|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358049|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358050|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358051|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358052|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358053|NCT00379236|O1|Outcome|EUFLEXXA™ Double Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358054|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358055|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358056|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358057|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358058|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
358092|NCT00379288|O2|Outcome|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
358093|NCT00379288|O1|Outcome|MF/F 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
358059|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
358060|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
358061|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
358740|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358741|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358062|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358063|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358064|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358065|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358066|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358067|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358068|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358069|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358070|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358071|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358072|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358073|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358074|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358075|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358076|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358077|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358078|NCT00379236|E3|Reported Event|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
358079|NCT00379236|E2|Reported Event|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358080|NCT00379236|E1|Reported Event|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
358081|NCT00379288|B5|Baseline|Total|Total of all reporting groups
358082|NCT00379288|B4|Baseline|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
358083|NCT00379288|B3|Baseline|F/SC 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
358084|NCT00379288|B2|Baseline|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
358085|NCT00379288|B1|Baseline|MF/F 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
358086|NCT00379288|P4|Participant Flow|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
358087|NCT00379288|P3|Participant Flow|F/SC 250/50 mcg BID|fluticasone/salmeterol combination (F/SC) 250/50 twice daily for 1 year
358088|NCT00379288|P2|Participant Flow|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
358095|NCT00379288|E3|Reported Event|F/SC MDI 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
358096|NCT00379288|E2|Reported Event|MF/F MDI 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
358097|NCT00379288|E1|Reported Event|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
358098|NCT00379340|B6|Baseline|Total|Total of all reporting groups
358099|NCT00379340|B5|Baseline|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
358100|NCT00379340|B4|Baseline|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
358101|NCT00379340|B3|Baseline|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
358103|NCT00379340|B1|Baseline|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
358104|NCT00379340|P5|Participant Flow|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
358105|NCT00379340|P4|Participant Flow|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
358106|NCT00379340|P3|Participant Flow|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
358107|NCT00379340|P2|Participant Flow|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
358108|NCT00379340|P1|Participant Flow|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
358109|NCT00379340|O2|Outcome|Lung Mets > 1cm|Lung mets > 1cm
358110|NCT00379340|O1|Outcome|Lung Mets <= 1cm|Lung mets <= 1cm
358111|NCT00379340|O2|Outcome|Stage IV With Non-lung Disease Treated With Regimen M|"Stage IV with non-lung disease treated with Regimen M
doxorubicin hydrochloride: Given IV
liposomal vincristine sulfate: Given IV
conventional surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
etoposide: Given IV"
358112|NCT00379340|O1|Outcome|Stage III/IV With LOH 1p and 16q Treated With Regimen M|"Stage III/IV with LOH 1p and 16q treated with Regimen M
doxorubicin hydrochloride: Given IV
liposomal vincristine sulfate: Given IV
conventional surgery
3-dimensional conformal radiation therapy
dactinomycin: Given IV
cyclophosphamide: Given IV
etoposide: Given IV"
358113|NCT00379340|O1|Outcome|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|"Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A
doxorubicin hydrochloride: Given IV
liposomal vincristine sulfate: Given IV
conventional surgery
3-dimensional conformal radiation therapy
dactinomycin: Given IV
cyclophosphamide: Given IV
etoposide: Given IV"
358114|NCT00379340|O1|Outcome|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
358115|NCT00379340|E5|Reported Event|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
358116|NCT00379340|E4|Reported Event|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
358117|NCT00379340|E3|Reported Event|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
358118|NCT00379340|E2|Reported Event|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
358119|NCT00379340|E1|Reported Event|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
358120|NCT00379353|B3|Baseline|Total|Total of all reporting groups
358121|NCT00379353|B2|Baseline|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
358122|NCT00379353|B1|Baseline|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
358123|NCT00379353|P2|Participant Flow|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
358124|NCT00379353|P1|Participant Flow|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
358125|NCT00379353|O4|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
358126|NCT00379353|O3|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
358127|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days
358128|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days
358129|NCT00379353|O6|Outcome|Placebo (Day 29)|Two placebo capsules orally, once a day for 14 days.
358130|NCT00379353|O5|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
358131|NCT00379353|O4|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
358132|NCT00379353|O3|Outcome|Thalidomide (Day 29)|Thalidomide 100 mg capsules orally, once a day for 14 days.
358133|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days.
358134|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days.
358135|NCT00379353|O6|Outcome|Placebo (Day 29)|Two placebo capsules orally, once a day for 14 days.
358136|NCT00379353|O5|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
358137|NCT00379353|O4|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
358138|NCT00379353|O3|Outcome|Thalidomide (Day 29)|Thalidomide 100 mg capsules orally, once a day for 14 days.
358139|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days.
358140|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days.
358141|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
358142|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
358143|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
358144|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
358145|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
358146|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
358147|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
358148|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
358149|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
358150|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
358151|NCT00379353|E2|Reported Event|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
358154|NCT00379574|P1|Participant Flow|Bortezomib + CHOP Every 2 Weeks|"Phase I Bortezomib 1.0, 1/3, and 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5
Phase II Bortezomib 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5"
358155|NCT00379574|O1|Outcome|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
358156|NCT00379574|O1|Outcome|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
358157|NCT00379574|E1|Reported Event|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
358158|NCT00379587|B1|Baseline|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
358159|NCT00379587|P1|Participant Flow|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
358160|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
358161|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
358162|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
358163|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
358164|NCT00379587|E1|Reported Event|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
358165|NCT00379639|B6|Baseline|Total|Total of all reporting groups
358166|NCT00379639|B5|Baseline|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358167|NCT00379639|B4|Baseline|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
358168|NCT00379639|B3|Baseline|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358169|NCT00379639|B2|Baseline|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358170|NCT00379639|B1|Baseline|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358171|NCT00379639|P5|Participant Flow|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358172|NCT00379639|P4|Participant Flow|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
358173|NCT00379639|P3|Participant Flow|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358174|NCT00379639|P2|Participant Flow|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358175|NCT00379639|P1|Participant Flow|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358176|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358177|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
358178|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358179|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358180|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358181|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358182|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
358183|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358184|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358185|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358186|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358187|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
358188|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358189|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358190|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358191|NCT00379639|E5|Reported Event|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358192|NCT00379639|E4|Reported Event|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
358193|NCT00379639|E3|Reported Event|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
358194|NCT00379639|E2|Reported Event|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358195|NCT00379639|E1|Reported Event|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
358196|NCT00379769|B5|Baseline|Total|Total of all reporting groups
358197|NCT00379769|B4|Baseline|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358198|NCT00379769|B3|Baseline|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358199|NCT00379769|B2|Baseline|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358200|NCT00379769|B1|Baseline|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358201|NCT00379769|P6|Participant Flow|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358202|NCT00379769|P5|Participant Flow|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358203|NCT00379769|P4|Participant Flow|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358204|NCT00379769|P3|Participant Flow|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358205|NCT00379769|P2|Participant Flow|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358206|NCT00379769|P1|Participant Flow|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358207|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358208|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358209|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358210|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358211|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358212|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358213|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358214|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358607|NCT00379912|O2|Outcome|Arm B Azacitidine|"Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
358215|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358216|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358217|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358218|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
361083|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
358219|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358220|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358221|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358222|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358223|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358224|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358225|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358226|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358227|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358228|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358229|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358230|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358231|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358232|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358233|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358234|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358235|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358647|NCT00380081|B5|Baseline|Zolpidem 1.75/Placebo/Zolpidem 3.5|Cross-over interventions administered in the order listed.
358728|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358236|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358237|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358238|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358239|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358240|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358241|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358242|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358243|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358244|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358245|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358246|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
358247|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358248|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
358249|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358250|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
358251|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358252|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
358268|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358648|NCT00380081|B4|Baseline|Zolpidem 3.5/Zolpidem 1.75/Placebo|Cross-over interventions administered in the order listed.
358649|NCT00380081|B3|Baseline|Zolpidem 3.5/Placebo/Zolpidem 1.75|Cross-over interventions administered in the order listed.
358253|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358254|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
358309|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358255|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358256|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
358257|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358258|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
358259|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358260|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
358261|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358262|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
358263|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358264|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
358265|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358266|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358267|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358420|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358269|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358270|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358310|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358271|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358272|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358273|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358274|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358275|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358276|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358277|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358278|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358279|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358280|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358281|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358282|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358283|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358284|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358285|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358286|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358287|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358288|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
361030|NCT00386334|O1|Outcome|Placebo|Placebo tablets
358289|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358290|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358291|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358292|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358293|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358294|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358295|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358296|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358297|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358298|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358299|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358300|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358301|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358302|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358303|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358304|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358305|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358306|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358307|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358421|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
361031|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
358308|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358423|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
361084|NCT00386334|O1|Outcome|Placebo|Placebo tablets
358311|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358312|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358313|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358314|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358315|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358316|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358317|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358318|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358319|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358320|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358321|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358322|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358323|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358324|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358325|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358326|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358546|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358547|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358327|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358328|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358424|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358329|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358330|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358331|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358332|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358333|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358334|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358335|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358336|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358337|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358338|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358339|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358340|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358341|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358342|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358343|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358344|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358548|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358650|NCT00380081|B2|Baseline|Placebo/Zolpidem 1.75/Zolpidem 3.5|Cross-over interventions administered in the order listed.
358345|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358346|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358347|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358348|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358349|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358350|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358351|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358352|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358353|NCT00379769|E6|Reported Event|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358354|NCT00379769|E5|Reported Event|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
358355|NCT00379769|E4|Reported Event|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358356|NCT00379769|E3|Reported Event|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358357|NCT00379769|E2|Reported Event|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358358|NCT00379769|E1|Reported Event|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
358359|NCT00379795|B6|Baseline|Total|Total of all reporting groups
358360|NCT00379795|B5|Baseline|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were previously enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594), FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or in this extension study (FVF3426g).
358361|NCT00379795|B4|Baseline|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injections in previous studies FVF2428g, study FVF2587g or this extension study.
358651|NCT00380081|B1|Baseline|Placebo/Zolpidem 3.5/Zolpidem 1.75|Cross-over interventions administered in the order listed.
358362|NCT00379795|B3|Baseline|RanibizumabTreated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5mg intravitreal injections in previous study FVF2598g or in this extension study.
358425|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358363|NCT00379795|B2|Baseline|RanibizumabTreated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injections in combination with photodynamic therapy in Study FVF2428g.
358364|NCT00379795|B1|Baseline|RanibizumabTreated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab 0.5 mg monotherapy, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
358365|NCT00379795|P5|Participant Flow|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) FVF2598g (NCT0056823) but did not receive Ranibizumab intravitreal injections in that study or in this extension study (FVF3426g).
358366|NCT00379795|P4|Participant Flow|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab intravitreal injections in study FVF2428g, study FVF2587g or this study.
358367|NCT00379795|P3|Participant Flow|RanibizumabTreated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab intravitreal injections in study FVF2598g or this extension study.
358368|NCT00379795|P2|Participant Flow|RanibizumabTreated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab in combination with photodynamic therapy in Study FVF2428g
358369|NCT00379795|P1|Participant Flow|RanibizumabTreated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab monotherapy (Mono) in previous studies, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
358370|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
358371|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
358372|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
358373|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
358374|NCT00379795|O4|Outcome|Total|All enrolled subjects
358375|NCT00379795|O3|Outcome|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.
358652|NCT00380081|P6|Participant Flow|Zolpidem 1.75/Zolpidem 3.5/Placebo|Cross-over interventions administered in the order listed.
358376|NCT00379795|O2|Outcome|Ranibizumab Crossover Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in the initial study or this extension study.
361085|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
358377|NCT00379795|O1|Outcome|Ranibizumab Initial Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
358378|NCT00379795|O4|Outcome|Total|All enrolled subjects
358379|NCT00379795|O3|Outcome|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.
358380|NCT00379795|O2|Outcome|Ranibizumab Crossover Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in that initial study or this extension study.
358381|NCT00379795|O1|Outcome|Ranibizumab Initial Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
358382|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
358383|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
358384|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
358385|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
358386|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
358387|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
358388|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
358389|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
361032|NCT00386334|O1|Outcome|Placebo|Placebo tablets
358422|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358517|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358390|NCT00379795|E4|Reported Event|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
358391|NCT00379795|E3|Reported Event|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g or this extension study.
358392|NCT00379795|E2|Reported Event|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
358393|NCT00379795|E1|Reported Event|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
358394|NCT00379808|B1|Baseline|All Participants|Patients were randomized in a crossover design, but baseline characteristics were presented for all participants. Likewise data are not separated by order of treatment because there were no order effects
358395|NCT00379808|P2|Participant Flow|Montelukast Then Placebo|Patients were randomized in a crossover design to placebo or montelukast. Patients in this arm got montelukast for 4 weeks and then placebo for 4 weeks. There was no washout period
358396|NCT00379808|P1|Participant Flow|Placebo Then Montelukast|Patients were randomized in a crossover design to placebo or montelukast. Patients int this randomization arm received 4 weeks of placebo then 4 weeks of montelukast. There was no washout between crossover
358397|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
358398|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
358399|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
358400|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
358401|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
358402|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
358403|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
358404|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
358405|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
358406|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
358407|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
358408|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
358409|NCT00379808|E2|Reported Event|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
358410|NCT00379808|E1|Reported Event|Placebo|This is all participants who received placebo, whether in first or second intervention
358411|NCT00379821|B5|Baseline|Total|Total of all reporting groups
358412|NCT00379821|B4|Baseline|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358413|NCT00379821|B3|Baseline|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358414|NCT00379821|B2|Baseline|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358415|NCT00379821|B1|Baseline|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358416|NCT00379821|P4|Participant Flow|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358417|NCT00379821|P3|Participant Flow|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358418|NCT00379821|P2|Participant Flow|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358419|NCT00379821|P1|Participant Flow|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358729|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358426|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358427|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358428|NCT00379821|O1|Outcome|All Groups|Participants Receiving Any Treatment in the Study
358429|NCT00379821|O2|Outcome|Participants Who Did Not Travel and Sleep Outside the City|At enrollment, participants were asked if they travelled and slept outside the city within the previous 4 weeks. This group indicated no.
358430|NCT00379821|O1|Outcome|Participants Who Traveled and Slept Outside the City|At enrollment, participants were asked if they travelled and slept outside the city within the previous 4 weeks. This group indicated yes.
358431|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358432|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358433|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358434|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358435|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358436|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358437|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358438|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358439|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358440|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358441|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358442|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358443|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358444|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358445|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358446|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358447|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358448|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358449|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358450|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358451|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358452|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358653|NCT00380081|P5|Participant Flow|Zolpidem 1.75/Placebo/Zolpidem 3.5|Cross-over interventions administered in the order listed.
358453|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358454|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358455|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358518|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
361086|NCT00386334|O1|Outcome|Placebo|Placebo tablets
358456|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358457|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358458|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358459|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358460|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358461|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358462|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358463|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358464|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358465|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358466|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358467|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358468|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358469|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358470|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358471|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358472|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358473|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358474|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358475|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358476|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358477|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358478|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358479|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358480|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358481|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358482|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358483|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358606|NCT00379912|O1|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
358484|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358485|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358742|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358486|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358487|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358488|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358489|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358490|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358491|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358492|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358493|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358494|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358495|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358496|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358497|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358498|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358499|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358500|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358501|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358502|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358503|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358504|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358505|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358506|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358507|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358508|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358509|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358510|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358511|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358512|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358513|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358514|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
361033|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
358515|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358516|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358519|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358520|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358521|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358522|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358523|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358524|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358525|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358526|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358527|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358528|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358529|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358530|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358531|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358532|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358533|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Subjects receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358534|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Subjects receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358535|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358536|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358537|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358538|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358539|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358540|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358541|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358542|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358543|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358544|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358545|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
361034|NCT00386334|O1|Outcome|Placebo|Placebo tablets
358549|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358550|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358551|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358552|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358553|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358554|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358555|NCT00379821|E4|Reported Event|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
358556|NCT00379821|E3|Reported Event|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
358557|NCT00379821|E2|Reported Event|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
358558|NCT00379821|E1|Reported Event|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
358559|NCT00379834|B1|Baseline|Cosopt|Cosopt BID OU
358560|NCT00379834|P1|Participant Flow|Cosopt|Cosopt BID OU
358561|NCT00379834|O1|Outcome|Cosopt|Cosopt twice daily in both eyes
358562|NCT00379834|E1|Reported Event|Cosopt|Cosopt twice daily in both eyes
358563|NCT00379899|B3|Baseline|Total|Total of all reporting groups
358564|NCT00379899|B2|Baseline|Control|Flexible vitamin D dosing
358565|NCT00379899|B1|Baseline|Cinacalcet|Cinacalcet plus low dose vitamin D
358566|NCT00379899|P2|Participant Flow|Control|Flexible vitamin D dosing
358567|NCT00379899|P1|Participant Flow|Cinacalcet|Cinacalcet plus low dose vitamin D
358568|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358569|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358570|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358571|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358572|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358573|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358574|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358575|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358576|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358577|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358578|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358579|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358580|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358581|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358582|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358583|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358584|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358585|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358586|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358587|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358588|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358589|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358590|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
358591|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
358592|NCT00379899|E2|Reported Event|Control Group|
358593|NCT00379899|E1|Reported Event|Cinacalcet|
358594|NCT00379912|B3|Baseline|Total|Total of all reporting groups
358595|NCT00379912|B2|Baseline|Arm B Azacitidine|"Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
358596|NCT00379912|B1|Baseline|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
358597|NCT00379912|P2|Participant Flow|Arm B Azacitidine|"Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
358598|NCT00379912|P1|Participant Flow|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
358599|NCT00379912|O2|Outcome|Non-Responders|Non-Responders
358600|NCT00379912|O1|Outcome|Responders|Responders
358601|NCT00379912|O2|Outcome|Non-Responders|Non-Responders
358602|NCT00379912|O1|Outcome|Responders|Responders
358603|NCT00379912|O2|Outcome|Non-Responders|Non-Responders
358604|NCT00379912|O1|Outcome|Responders|Responders
358605|NCT00379912|O2|Outcome|Arm B Azacitidine|"Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
358730|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358608|NCT00379912|O1|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
358609|NCT00379912|O2|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
358610|NCT00379912|O1|Outcome|Arm B Azacitidine|"Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
358743|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358612|NCT00379912|O1|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
358613|NCT00379912|E2|Reported Event|Arm B Azacitidine|"Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
358614|NCT00379912|E1|Reported Event|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
358615|NCT00380029|B1|Baseline|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT
Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression
Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
358616|NCT00380029|P1|Participant Flow|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT
Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression
Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
358617|NCT00380029|O2|Outcome|Adjuvant Erlotinib|Patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression.
358618|NCT00380029|O1|Outcome|Neoadjuvant Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT
Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
358619|NCT00380029|O1|Outcome|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT
Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression
Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
358620|NCT00380029|O1|Outcome|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT
Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression
Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
358621|NCT00380029|O1|Outcome|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT
Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression
Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
358622|NCT00380029|O2|Outcome|Not-downstaged|transurethral resection of a bladder tumor, (TURBT) tumors resected from participants treated with neo-adjuvant erlotinib which were considered to be not-downstaged ( pathologic stage at cystectomy >=pT2 or node positive (N1 or N2))
358623|NCT00380029|O1|Outcome|Downstaged Tumors|transurethral resection of a bladder tumor, (TURBT) tumors resected from participants treated with neo-adjuvant erlotinib which were considered to be downstaged ( pathologic tumor stage at cystectomy <pT2 and N0)
358624|NCT00380029|E1|Reported Event|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT
Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression
Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
358625|NCT00380068|B1|Baseline|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358626|NCT00380068|P1|Participant Flow|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358627|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358654|NCT00380081|P4|Participant Flow|Zolpidem 3.5/Zolpidem 1.75/Placebo|Cross-over interventions administered in the order listed.
358628|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358629|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358744|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358630|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358631|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358632|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358633|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358634|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358635|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358636|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358637|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358638|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358639|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358640|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358641|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358642|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358643|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358644|NCT00380068|E1|Reported Event|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
358645|NCT00380081|B7|Baseline|Total|Total of all reporting groups
358646|NCT00380081|B6|Baseline|Zolpidem 1.75/Zolpidem 3.5/Placebo|Cross-over interventions administered in the order listed.
358655|NCT00380081|P3|Participant Flow|Zolpidem 3.5/Placebo/Zolpidem 1.75|Cross-over interventions administered in the order listed.
358656|NCT00380081|P2|Participant Flow|Placebo/Zolpidem 1.75/Zolpidem 3.5|Cross-over interventions administered in the order listed.
358657|NCT00380081|P1|Participant Flow|Placebo/Zolpidem 3.5/Zolpidem 1.75|Cross-over interventions administered in the order listed.
358658|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358688|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358659|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358660|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358661|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358662|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358663|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358664|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358665|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358666|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358667|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358668|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358669|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358670|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358671|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358672|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358673|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358674|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358675|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358676|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358677|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358678|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358679|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358680|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358681|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358682|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358683|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358684|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358685|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358686|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358687|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358738|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358689|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358690|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358691|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358692|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358693|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358694|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358695|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358696|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358697|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358698|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358699|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358700|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358701|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358702|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358703|NCT00380081|E3|Reported Event|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358704|NCT00380081|E2|Reported Event|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358705|NCT00380081|E1|Reported Event|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
358706|NCT00380250|B3|Baseline|Total|Total of all reporting groups
358707|NCT00380250|B2|Baseline|Placebo Study Period I|Subjects who received placebo
358708|NCT00380250|B1|Baseline|Lubiprostone Study Period I|Subjects who received active drug
358709|NCT00380250|P2|Participant Flow|Placebo Study Period I|Subjects who received placebo
358710|NCT00380250|P1|Participant Flow|Lubiprostone Study Period I|Subjects who received active drug
358711|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358712|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358713|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358714|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358715|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358716|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358717|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358718|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358719|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358720|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358721|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358722|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358723|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358724|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358725|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358726|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358727|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
361035|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
358731|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358732|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358733|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358734|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358735|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358736|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358737|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358745|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358746|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358747|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358748|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358749|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358750|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358751|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358752|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358753|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358754|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358755|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358756|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358757|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358758|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358759|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358760|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358761|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358762|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358763|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358764|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358765|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358766|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358767|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
358768|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
358769|NCT00380250|E2|Reported Event|Placebo Study Period I|Matching placebo capsules twice daily (BID)
358770|NCT00380250|E1|Reported Event|Lubiprostone Study Period I|8 mcg capsules twice daily (BID)
358771|NCT00380367|B1|Baseline|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
358772|NCT00380367|P1|Participant Flow|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
358773|NCT00380367|O1|Outcome|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
358774|NCT00380367|O1|Outcome|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
358775|NCT00380367|E1|Reported Event|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
358776|NCT00380588|B3|Baseline|Total|Total of all reporting groups
358777|NCT00380588|B2|Baseline|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
358778|NCT00380588|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
358779|NCT00380588|P2|Participant Flow|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
358780|NCT00380588|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
358876|NCT00380874|E2|Reported Event|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
358781|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
358782|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
358783|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
358784|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
359029|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
358785|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
358786|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
358787|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
358788|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
358789|NCT00380588|E2|Reported Event|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
358790|NCT00380588|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
358791|NCT00380692|B3|Baseline|Total|Total of all reporting groups
358792|NCT00380692|B2|Baseline|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358793|NCT00380692|B1|Baseline|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358794|NCT00380692|P2|Participant Flow|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358795|NCT00380692|P1|Participant Flow|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358796|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358797|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358798|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358799|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358800|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358801|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358802|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358803|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358804|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358805|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358806|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358807|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358808|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358809|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358810|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358811|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358812|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358813|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358814|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358815|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358816|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358817|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358818|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358819|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358820|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358821|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358822|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358823|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358824|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358825|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358826|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358827|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358828|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358829|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358830|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358831|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358832|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358833|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358834|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358835|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358836|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358837|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358838|NCT00380692|E2|Reported Event|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
358839|NCT00380692|E1|Reported Event|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
358840|NCT00380718|B1|Baseline|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
358841|NCT00380718|P1|Participant Flow|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
358842|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
358843|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
359024|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
358844|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
358845|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
358846|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
358847|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
358848|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
358849|NCT00380718|E1|Reported Event|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
358850|NCT00380861|B3|Baseline|Total|Total of all reporting groups
358851|NCT00380861|B2|Baseline|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
358852|NCT00380861|B1|Baseline|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
358853|NCT00380861|P2|Participant Flow|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
358854|NCT00380861|P1|Participant Flow|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
358855|NCT00380861|O2|Outcome|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
358856|NCT00380861|O1|Outcome|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
358857|NCT00380861|E2|Reported Event|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
358858|NCT00380861|E1|Reported Event|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
358859|NCT00380874|B3|Baseline|Total|Total of all reporting groups
358860|NCT00380874|B2|Baseline|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
358861|NCT00380874|B1|Baseline|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
358862|NCT00380874|P2|Participant Flow|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
358863|NCT00380874|P1|Participant Flow|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
358864|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
358865|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
358866|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
358867|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
358868|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
358869|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
358870|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
358871|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
358872|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
358873|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
358874|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
358875|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
361036|NCT00386334|O1|Outcome|Placebo|Placebo tablets
358877|NCT00380874|E1|Reported Event|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
358878|NCT00380978|B3|Baseline|Total|Total of all reporting groups
358879|NCT00380978|B2|Baseline|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
358880|NCT00380978|B1|Baseline|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
359030|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
361087|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
358881|NCT00380978|P2|Participant Flow|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
358882|NCT00380978|P1|Participant Flow|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
358883|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
358884|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
358885|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
358886|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
358887|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
358888|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
358889|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
358890|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
358891|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
358892|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
358893|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
358894|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
358895|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
358896|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
358897|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
358898|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
358899|NCT00380978|E2|Reported Event|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
358900|NCT00380978|E1|Reported Event|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
358922|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358901|NCT00381004|B1|Baseline|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
358902|NCT00381004|P1|Participant Flow|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
359110|NCT00381303|O3|Outcome|Black|
359111|NCT00381303|O2|Outcome|Male|
358903|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
358904|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
358905|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
358906|NCT00381004|E1|Reported Event|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
358907|NCT00381043|B3|Baseline|Total|Total of all reporting groups
358908|NCT00381043|B2|Baseline|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358909|NCT00381043|B1|Baseline|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358910|NCT00381043|P2|Participant Flow|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358911|NCT00381043|P1|Participant Flow|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358912|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358913|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358914|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358915|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358916|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358917|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358918|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358919|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358920|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358921|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358923|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358924|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358925|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
359112|NCT00381303|O1|Outcome|Female|
358926|NCT00381043|E2|Reported Event|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358927|NCT00381043|E1|Reported Event|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
358928|NCT00381095|B3|Baseline|Total|Total of all reporting groups
358929|NCT00381095|B2|Baseline|Placebo|Matching placebo capsules orally twice per day
358930|NCT00381095|B1|Baseline|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358931|NCT00381095|P2|Participant Flow|Placebo|Matching placebo capsules orally twice per day
358932|NCT00381095|P1|Participant Flow|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358933|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358934|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358935|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358936|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358937|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358938|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358939|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358940|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358941|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358942|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358943|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358944|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358945|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358946|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358947|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358948|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358949|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358950|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358951|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358952|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358953|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358954|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358955|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
358956|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358957|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
359097|NCT00381303|O2|Outcome|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
358958|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358959|NCT00381095|E2|Reported Event|Placebo|Matching placebo capsules orally twice per day
358960|NCT00381095|E1|Reported Event|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
358961|NCT00375427|B3|Baseline|Total|Total of all reporting groups
359113|NCT00381303|O7|Outcome|Other|
359114|NCT00381303|O6|Outcome|Asian|
358962|NCT00375427|B2|Baseline|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
358963|NCT00375427|B1|Baseline|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358964|NCT00375427|P2|Participant Flow|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
358965|NCT00375427|P1|Participant Flow|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358966|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
358967|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358968|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
358969|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358970|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
358971|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358972|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
358973|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358974|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
358975|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358976|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
358977|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358978|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
358979|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358980|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
358981|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358982|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
359115|NCT00381303|O5|Outcome|Hispanic|
358983|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358984|NCT00375427|E2|Reported Event|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions
358985|NCT00375427|E1|Reported Event|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
358986|NCT00375492|B3|Baseline|Total|Total of all reporting groups
358987|NCT00375492|B2|Baseline|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
358988|NCT00375492|B1|Baseline|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
358989|NCT00375492|P2|Participant Flow|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
358990|NCT00375492|P1|Participant Flow|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
358991|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
358992|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
358993|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
358994|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
358995|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
358996|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
358997|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
358998|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
358999|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
359000|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
359001|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
359002|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
359003|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
359004|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
359005|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
359006|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
359007|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
359008|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
359009|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
359010|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
359011|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
359012|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
359013|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
359014|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
359015|NCT00375492|E2|Reported Event|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
359016|NCT00375492|E1|Reported Event|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
359017|NCT00375505|B3|Baseline|Total|Total of all reporting groups
359018|NCT00375505|B2|Baseline|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359019|NCT00375505|B1|Baseline|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359020|NCT00375505|P2|Participant Flow|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359021|NCT00375505|P1|Participant Flow|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359022|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359023|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359025|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359026|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359027|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359028|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359031|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359032|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359033|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359034|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359035|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359036|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359037|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359038|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359039|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359040|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359041|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359042|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359043|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359044|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359045|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359046|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359047|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359048|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359049|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359050|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359051|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359052|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359053|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359054|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359055|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359056|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359057|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359058|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359059|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359060|NCT00375505|E2|Reported Event|Zometa|Zometa
359061|NCT00375505|E1|Reported Event|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
359062|NCT00375518|B3|Baseline|Total|Total of all reporting groups
359063|NCT00375518|B2|Baseline|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
359064|NCT00375518|B1|Baseline|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
359065|NCT00375518|P2|Participant Flow|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
359066|NCT00375518|P1|Participant Flow|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
359067|NCT00375518|O2|Outcome|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
359171|NCT00382408|B3|Baseline|Total|Total of all reporting groups
359068|NCT00375518|O1|Outcome|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
359069|NCT00375518|E2|Reported Event|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
359070|NCT00375518|E1|Reported Event|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
359116|NCT00381303|O4|Outcome|Caucasian|
359117|NCT00381303|O3|Outcome|Black|
359118|NCT00381303|O2|Outcome|Male|
359071|NCT00381238|B1|Baseline|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359072|NCT00381238|P1|Participant Flow|RSG XR, 8 mg|The study duration was of 50-week (Wk), which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received Rosiglitazone (RSG) extended release (XR), 4 milligram (mg) tablets once daily (od), orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359073|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359074|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359075|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359076|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359077|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359078|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359079|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359080|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359081|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359082|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359083|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359084|NCT00381238|E1|Reported Event|RSG XR, 8 MG|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
359085|NCT00381303|B3|Baseline|Total|Total of all reporting groups
359086|NCT00381303|B2|Baseline|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
359087|NCT00381303|B1|Baseline|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
359088|NCT00381303|P2|Participant Flow|Male|darunavir 600 mg twice bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
359089|NCT00381303|P1|Participant Flow|Female|darunavir 600 milligram (mg) twice daily dosing (bid) for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
359090|NCT00381303|O7|Outcome|Other|
359091|NCT00381303|O6|Outcome|Asian|
359092|NCT00381303|O5|Outcome|Hispanic|
359093|NCT00381303|O4|Outcome|Caucasian|
359094|NCT00381303|O3|Outcome|Black|
359095|NCT00381303|O2|Outcome|Male|
359096|NCT00381303|O1|Outcome|Female|
359311|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359098|NCT00381303|O1|Outcome|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
359099|NCT00381303|O7|Outcome|Other|
359100|NCT00381303|O6|Outcome|Asian|
359101|NCT00381303|O5|Outcome|Hispanic|
359102|NCT00381303|O4|Outcome|Caucasian|
359103|NCT00381303|O3|Outcome|Black|
359104|NCT00381303|O2|Outcome|Male|
359105|NCT00381303|O1|Outcome|Female|
359106|NCT00381303|O7|Outcome|Other|
359107|NCT00381303|O6|Outcome|Asian|
359108|NCT00381303|O5|Outcome|Hispanic|
359109|NCT00381303|O4|Outcome|Caucasian|
359144|NCT00381303|O2|Outcome|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
359145|NCT00381303|O1|Outcome|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
359146|NCT00381303|E2|Reported Event|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
359147|NCT00381303|E1|Reported Event|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
359148|NCT00381381|B1|Baseline|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
359149|NCT00381381|P1|Participant Flow|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
359150|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
359151|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
359152|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
359153|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
359154|NCT00381381|E1|Reported Event|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
359155|NCT00382291|B4|Baseline|Total|Total of all reporting groups
359156|NCT00382291|B3|Baseline|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
359157|NCT00382291|B2|Baseline|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
359158|NCT00382291|B1|Baseline|Placebo|Placebo plus cognitive behavior therapy.
359159|NCT00382291|P3|Participant Flow|Slow Sertraline Titration Plus CBT|Slow titration of sertraline (SloSert)plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
359160|NCT00382291|P2|Participant Flow|Regular Sertraline Titration Plus CBT|Regular titration of sertraline (RegSert) plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
359161|NCT00382291|P1|Participant Flow|Placebo Plus CBT|Placebo plus cognitive behavior therapy (CBT).
359162|NCT00382291|O3|Outcome|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
359163|NCT00382291|O2|Outcome|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
359164|NCT00382291|O1|Outcome|Placebo|Placebo plus cognitive behavior therapy.
359165|NCT00382291|O3|Outcome|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
359166|NCT00382291|O2|Outcome|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
359167|NCT00382291|O1|Outcome|Placebo|Placebo plus cognitive behavior therapy.
359168|NCT00382291|E3|Reported Event|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
359169|NCT00382291|E2|Reported Event|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
359170|NCT00382291|E1|Reported Event|Placebo|Placebo plus cognitive behavior therapy.
359172|NCT00382408|B2|Baseline|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359173|NCT00382408|B1|Baseline|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359174|NCT00382408|P2|Participant Flow|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359175|NCT00382408|P1|Participant Flow|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359176|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359177|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359178|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359179|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359180|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359181|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359182|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359183|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359184|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359185|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359186|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359187|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359262|NCT00382863|B2|Baseline|Control|Optimal Medical/Device Therapy alone
359188|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359189|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359190|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359191|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359192|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359193|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359194|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359195|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359196|NCT00382408|E2|Reported Event|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359197|NCT00382408|E1|Reported Event|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
359198|NCT00382590|B3|Baseline|Total|Total of all reporting groups
359199|NCT00382590|B2|Baseline|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
359200|NCT00382590|B1|Baseline|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
359201|NCT00382590|P2|Participant Flow|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
359202|NCT00382590|P1|Participant Flow|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
359203|NCT00382590|O2|Outcome|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
359204|NCT00382590|O1|Outcome|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
359205|NCT00382590|E2|Reported Event|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
359206|NCT00382590|E1|Reported Event|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
359207|NCT00382720|B4|Baseline|Total|Total of all reporting groups
359208|NCT00382720|B3|Baseline|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
359209|NCT00382720|B2|Baseline|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
359210|NCT00382720|B1|Baseline|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
359211|NCT00382720|P3|Participant Flow|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
359242|NCT00382733|O1|Outcome|Metronomic Oral Topotecan|All subjects received metronomic oral topotecan daily at the assigned dose level.
359212|NCT00382720|P2|Participant Flow|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
359213|NCT00382720|P1|Participant Flow|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
359214|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
359215|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
359216|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
359217|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
359218|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
359219|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
359263|NCT00382863|B1|Baseline|Treatment|HeartNet and Optimal Medical/Device Therapy
359264|NCT00382863|P2|Participant Flow|Control|Optimal Medical/Device Therapy alone
361088|NCT00386334|O1|Outcome|Placebo|Placebo tablets
359220|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
359221|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
359222|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
359223|NCT00382720|E3|Reported Event|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
359224|NCT00382720|E2|Reported Event|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
359225|NCT00382720|E1|Reported Event|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
359226|NCT00382733|B1|Baseline|Metronomic Oral Topotecan|All subjects received metronomic oral topotecan daily at the assigned dose level.
359227|NCT00382733|P5|Participant Flow|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
359228|NCT00382733|P4|Participant Flow|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
359229|NCT00382733|P3|Participant Flow|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
359230|NCT00382733|P2|Participant Flow|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
359231|NCT00382733|P1|Participant Flow|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
359232|NCT00382733|O5|Outcome|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
359233|NCT00382733|O4|Outcome|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
359234|NCT00382733|O3|Outcome|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
359235|NCT00382733|O2|Outcome|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
359236|NCT00382733|O1|Outcome|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
359237|NCT00382733|O5|Outcome|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
359238|NCT00382733|O4|Outcome|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
359239|NCT00382733|O3|Outcome|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
359240|NCT00382733|O2|Outcome|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
359241|NCT00382733|O1|Outcome|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
359312|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359243|NCT00382733|E5|Reported Event|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
359244|NCT00382733|E4|Reported Event|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
359245|NCT00382733|E3|Reported Event|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
359246|NCT00382733|E2|Reported Event|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
359247|NCT00382733|E1|Reported Event|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
359248|NCT00382785|B3|Baseline|Total|Total of all reporting groups
359249|NCT00382785|B2|Baseline|Non-facilitated (Peer-led)|12-week online support in a peer-led format
359250|NCT00382785|B1|Baseline|Moderated Group|one 12-week online support group led by a professional healthcare provider
359251|NCT00382785|P2|Participant Flow|Non-facilitated (Peer-led)|12-week online support in a peer-led format
359252|NCT00382785|P1|Participant Flow|Moderated Group|one 12-week online support group led by a professional healthcare provider
359253|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
359254|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
359255|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
359256|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
359257|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
359258|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
359259|NCT00382785|E2|Reported Event|Peer-led|peer-led group
359260|NCT00382785|E1|Reported Event|Moderated|
359261|NCT00382863|B3|Baseline|Total|Total of all reporting groups
359265|NCT00382863|P1|Participant Flow|Treatment|HeartNet and Optimal Medical/Device Therapy
359266|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359267|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359268|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359269|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359270|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359271|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359272|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359273|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359274|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359275|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359276|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359277|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359278|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359279|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359280|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359281|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359282|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359283|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359284|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359285|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359286|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359287|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359288|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359289|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359290|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359291|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359292|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359293|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359294|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359295|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359296|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359297|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359298|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359299|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359300|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359301|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359302|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359303|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359304|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359305|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359306|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359307|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359308|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359309|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359310|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359313|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359314|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
359315|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
359316|NCT00382863|E2|Reported Event|Control|Optimal Medical/Device Therapy alone
359317|NCT00382863|E1|Reported Event|Treatment|HeartNet and Optimal Medical/Device Therapy
359318|NCT00382928|B3|Baseline|Total|Total of all reporting groups
359319|NCT00382928|B2|Baseline|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
359320|NCT00382928|B1|Baseline|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
359321|NCT00382928|P2|Participant Flow|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
359322|NCT00382928|P1|Participant Flow|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention
359323|NCT00382928|O2|Outcome|Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
359324|NCT00382928|O1|Outcome|AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
359325|NCT00382928|O2|Outcome|No Intervention: Standard of Care|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
359326|NCT00382928|O1|Outcome|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
359327|NCT00382928|O2|Outcome|Standard of Care|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
359328|NCT00382928|O1|Outcome|AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
359329|NCT00382928|O2|Outcome|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
359330|NCT00382928|O1|Outcome|Experimental: AECD Monitoring + Stand of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
359331|NCT00382928|E2|Reported Event|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
359332|NCT00382928|E1|Reported Event|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
359333|NCT00382967|B3|Baseline|Total|Total of all reporting groups
359334|NCT00382967|B2|Baseline|Control Arm|No (Injection) Intervention
359335|NCT00382967|B1|Baseline|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
359336|NCT00382967|P2|Participant Flow|Control Arm|No (Injection) Intervention
359337|NCT00382967|P1|Participant Flow|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
359338|NCT00382967|O2|Outcome|Control Arm|No (Injection) Intervention
359339|NCT00382967|O1|Outcome|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
359340|NCT00382967|O2|Outcome|Control Arm|No (Injection) Intervention
359341|NCT00382967|O1|Outcome|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
359342|NCT00382967|E2|Reported Event|Control Arm|No (Injection) Intervention
359343|NCT00382967|E1|Reported Event|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
359344|NCT00382993|B1|Baseline|Safety Population|Safety Population – Participants who were randomized and who treated at least 1 migraine attack with investigational product.
359345|NCT00382993|P2|Participant Flow|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
359346|NCT00382993|P1|Participant Flow|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
359347|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
359348|NCT00382993|O1|Outcome|Placebo|
359349|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
359350|NCT00382993|O1|Outcome|Placebo|
359351|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
359352|NCT00382993|O1|Outcome|Placebo|
359353|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
359354|NCT00382993|O1|Outcome|Placebo|
359355|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
359356|NCT00382993|O1|Outcome|Placebo|
359357|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
359358|NCT00382993|O1|Outcome|Placebo|
359359|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
359360|NCT00382993|O1|Outcome|Placebo|
359361|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
359362|NCT00382993|O1|Outcome|Placebo|
359363|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
359364|NCT00382993|O1|Outcome|Placebo|
359365|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
359366|NCT00382993|O1|Outcome|Placebo|
359385|NCT00382993|E2|Reported Event|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
359386|NCT00382993|E1|Reported Event|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
359387|NCT00383019|B3|Baseline|Total|Total of all reporting groups
359388|NCT00383019|B2|Baseline|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359389|NCT00383019|B1|Baseline|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359390|NCT00383019|P2|Participant Flow|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359391|NCT00383019|P1|Participant Flow|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359392|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359393|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359394|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359395|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359396|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359397|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359398|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359399|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359571|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
359400|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359401|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359402|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359403|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359404|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359405|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359406|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359407|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359408|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359409|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359410|NCT00383019|E2|Reported Event|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
359411|NCT00383019|E1|Reported Event|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
359412|NCT00383071|B5|Baseline|Total|Total of all reporting groups
359413|NCT00383071|B4|Baseline|90 mcg|90 mcg IM every 4 weeks for 4 vaccinations
359414|NCT00383071|B3|Baseline|180 mcg Cohort 4|180 mcg IM every 4 weeks for 2 vaccinations
359415|NCT00383071|B2|Baseline|180 mcg|180 mcg IM every 4 weeks for 4 vaccinations
359416|NCT00383071|B1|Baseline|120 mcg|120 mcg IM every 4 weeks for 4 vaccinations
359417|NCT00383071|P4|Participant Flow|Cohort 1: 90 mcg|180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
359418|NCT00383071|P3|Participant Flow|Cohort 4: 180 mcg|120 mcg every 28 days x 2 doses. Subjects randomized to receive vaccination in arm or buttock.
359419|NCT00383071|P2|Participant Flow|Cohort 3: 180 mcg|180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
359420|NCT00383071|P1|Participant Flow|Cohort 2: 120 mcg|120 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
359421|NCT00383071|O4|Outcome|180 mcg Cohort 4|120 mcg IM every 4 weeks for 2 vaccinations
359422|NCT00383071|O3|Outcome|180 mcg|180 mcg IM every 4 weeks for 4 vaccinations
359423|NCT00383071|O2|Outcome|120 mcg|120 mcg IM every 4 weeks for 4 vaccinations
359424|NCT00383071|O1|Outcome|90 mcg|90 mcg IM every 4 weeks for 4 vaccinations
359425|NCT00383071|E4|Reported Event|90 mcg|90 mcg every 28 days x 4 doses
359426|NCT00383071|E3|Reported Event|180 mcg Cohort 4|180 mcg every 28 days x 2 doses
359427|NCT00383071|E2|Reported Event|180 mcg|180 mcg every 28 days x 4 doses
359428|NCT00383071|E1|Reported Event|120 mcg|120 mcg every 28 days x 4 doses
359429|NCT00383084|B3|Baseline|Total|Total of all reporting groups
359430|NCT00383084|B2|Baseline|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
359549|NCT00383240|B2|Baseline|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
361037|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
359431|NCT00383084|B1|Baseline|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
359432|NCT00383084|P2|Participant Flow|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
359433|NCT00383084|P1|Participant Flow|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
359434|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
359435|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
359436|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
359437|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
359438|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
359572|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
359439|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
359440|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
359441|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
359442|NCT00383084|E2|Reported Event|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
359443|NCT00383084|E1|Reported Event|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
359444|NCT00383110|B3|Baseline|Total|Total of all reporting groups
359445|NCT00383110|B2|Baseline|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
359446|NCT00383110|B1|Baseline|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359447|NCT00383110|P2|Participant Flow|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
359448|NCT00383110|P1|Participant Flow|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359449|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359450|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359451|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359452|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359453|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359454|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359455|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359456|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359457|NCT00383110|O2|Outcome|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
359458|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359459|NCT00383110|O2|Outcome|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
359460|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359461|NCT00383110|E2|Reported Event|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
359462|NCT00383110|E1|Reported Event|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
359463|NCT00383123|B3|Baseline|Total|Total of all reporting groups
359464|NCT00383123|B2|Baseline|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359551|NCT00383240|P4|Participant Flow|Placebo BID|Placebo MDI BID for 26 weeks
359465|NCT00383123|B1|Baseline|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359466|NCT00383123|P2|Participant Flow|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359467|NCT00383123|P1|Participant Flow|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359468|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359469|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359470|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359471|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359472|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359473|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359474|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359475|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359476|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359477|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359478|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359479|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359480|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359481|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359482|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359483|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359484|NCT00383123|E2|Reported Event|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359485|NCT00383123|E1|Reported Event|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
1:1 in 6 months to < 36 months
1:1 in 3 to < 5 years
3:1 in 5 to < 18 years"
359486|NCT00383149|B1|Baseline|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359487|NCT00383149|P1|Participant Flow|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359488|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359489|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359490|NCT00383149|O2|Outcome|Cetuximab|All participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359491|NCT00383149|O1|Outcome|Ixabepilone|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks.
359492|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359493|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359550|NCT00383240|B1|Baseline|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
359494|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359495|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359496|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359497|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359498|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359499|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359500|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359573|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
360219|NCT00384865|O3|Outcome|Simvastatin 40 mg|Simvastatin 40 mg, taken orally, once a day for 6 months
359501|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359502|NCT00383149|E1|Reported Event|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
359503|NCT00383162|B1|Baseline|Safety Population|Safety Population – Participants who were randomized and who treated at least 1 migraine attack with investigational product.
359504|NCT00383162|P2|Participant Flow|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
359505|NCT00383162|P1|Participant Flow|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
359506|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359507|NCT00383162|O1|Outcome|Placebo|
359508|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359509|NCT00383162|O1|Outcome|Placebo|
359510|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359511|NCT00383162|O1|Outcome|Placebo|
359512|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359513|NCT00383162|O1|Outcome|Placebo|
359514|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359515|NCT00383162|O1|Outcome|Placebo|
359516|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359517|NCT00383162|O1|Outcome|Placebo|
359518|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359519|NCT00383162|O1|Outcome|Placebo|
359520|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359521|NCT00383162|O1|Outcome|Placebo|
359522|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359523|NCT00383162|O1|Outcome|Placebo|
359524|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359525|NCT00383162|O1|Outcome|Placebo|
359526|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359527|NCT00383162|O1|Outcome|Placebo|
359528|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359529|NCT00383162|O1|Outcome|Placebo|
359530|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359531|NCT00383162|O1|Outcome|Placebo|
359532|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359533|NCT00383162|O1|Outcome|Placebo|
359534|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359535|NCT00383162|O1|Outcome|Placebo|
359536|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359537|NCT00383162|O1|Outcome|Placebo|
359538|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359539|NCT00383162|O1|Outcome|Placebo|
359540|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359541|NCT00383162|O1|Outcome|Placebo|
359542|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
359543|NCT00383162|O1|Outcome|Placebo|
359544|NCT00383162|E2|Reported Event|Sumatriptan-Naproxen Sodium|Subjects who were randomized to take Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 1, then a one week wash-out period without any drugs, and then given Placebo during Migraine period 2.
359545|NCT00383162|E1|Reported Event|Placebo|Subjects who were randomized to take Placebo during Migraine period 1, then a one week wash-out period without any drugs, and then given Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 2.
359546|NCT00383240|B5|Baseline|Total|Total of all reporting groups
359547|NCT00383240|B4|Baseline|Placebo BID|Placebo MDI BID for 26 weeks
359548|NCT00383240|B3|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
359762|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
359552|NCT00383240|P3|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
359553|NCT00383240|P2|Participant Flow|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
359554|NCT00383240|P1|Participant Flow|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
359555|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
359556|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
359557|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
359558|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
359559|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
359560|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
359561|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
359562|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
359563|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
359564|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
359565|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
359566|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
359567|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
359568|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
359569|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
359570|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
359574|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
359575|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
359576|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
359577|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
359578|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
359579|NCT00383240|E5|Reported Event|PLACEBO|
359580|NCT00383240|E4|Reported Event|F MDI 10 MCG BID|
359581|NCT00383240|E3|Reported Event|MF MDI 200 MCG BID|
359582|NCT00383240|E2|Reported Event|MF/F MDI 200/10 MCG BID|
359583|NCT00383240|E1|Reported Event|OL MF MDI 200 MCG BID|Participants received 2 to 3 weeks (approximately) of open-label (OL), run-in medication with MF MDI 200 mcg BID prior to the 26-week double-blind treatment period.
359584|NCT00383266|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m2 IV over 10 minutes
Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
Each cycle will last 21 days."
359585|NCT00383266|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes
Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
Each cycle will last 21 days."
359586|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes
Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
Each cycle will last 21 days."
359587|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes
Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
Each cycle will last 21 days."
359588|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes
Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
Each cycle will last 21 days."
359589|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes
Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
Each cycle will last 21 days."
359590|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes
Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
Each cycle will last 21 days."
359591|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes
Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
Each cycle will last 21 days."
359592|NCT00383266|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes
Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
Each cycle will last 21 days."
359593|NCT00383331|B3|Baseline|Total|Total of all reporting groups
359594|NCT00383331|B2|Baseline|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
359595|NCT00383331|B1|Baseline|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
359596|NCT00383331|P2|Participant Flow|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
359597|NCT00383331|P1|Participant Flow|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
359598|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
359599|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
359600|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
359601|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
359602|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
359603|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
359604|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
359605|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
359606|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
359607|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
359608|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
359609|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
359610|NCT00383331|E2|Reported Event|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
359611|NCT00383331|E1|Reported Event|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
359612|NCT00383435|B6|Baseline|Total|Total of all reporting groups
359613|NCT00383435|B5|Baseline|Placebo|Placebo MDI BID for 26 weeks
359614|NCT00383435|B4|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
359615|NCT00383435|B3|Baseline|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
359616|NCT00383435|B2|Baseline|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
359617|NCT00383435|B1|Baseline|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
359618|NCT00383435|P5|Participant Flow|Placebo|Placebo MDI BID for 26 weeks
359619|NCT00383435|P4|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
359620|NCT00383435|P3|Participant Flow|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
359621|NCT00383435|P2|Participant Flow|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
359622|NCT00383435|P1|Participant Flow|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
359623|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
359624|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
359625|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
359626|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
359627|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
359628|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
359629|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
359630|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
359631|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
359632|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
359633|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
359634|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
359635|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
359636|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
359637|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
359638|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
359639|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
359640|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
359641|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
359642|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
359643|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
359644|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
359645|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
359646|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
359647|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
359648|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
359649|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
359650|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
359651|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
359652|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
359653|NCT00383435|E5|Reported Event|PLACEBO|
359654|NCT00383435|E4|Reported Event|F MDI 10 MCG BID|
359655|NCT00383435|E3|Reported Event|MF MDI 400 MCG BID|
359656|NCT00383435|E2|Reported Event|MF/F MDI 400/10 MCG BID|
359657|NCT00383435|E1|Reported Event|MF/F MDI 200/10 MCG BID|
359658|NCT00383500|B4|Baseline|Total|Total of all reporting groups
359659|NCT00383500|B3|Baseline|Group III|This is the control group; they will receive no treatment
359660|NCT00383500|B2|Baseline|Group II|This group of patients will receive prophylactic MLD
359661|NCT00383500|B1|Baseline|Group I|This group of patients will receive the device.
359662|NCT00383500|P3|Participant Flow|No Intervention Control|No intervention observational control
359663|NCT00383500|P2|Participant Flow|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic massage therapy
359664|NCT00383500|P1|Participant Flow|Flexitouch Device|Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
359665|NCT00383500|O3|Outcome|No Intervention Control|No intervention observational control
359666|NCT00383500|O2|Outcome|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic massage therapy
359667|NCT00383500|O1|Outcome|Flexitouch Device|Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
359668|NCT00383500|O3|Outcome|No Intervention Control|No intervention observational control
359669|NCT00383500|O2|Outcome|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic drainage therapy
359670|NCT00383500|O1|Outcome|Flexitouch Device|Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
359671|NCT00383500|E3|Reported Event|Observational Control (no Intervention)|Control group, no intervention. No Flexitouch or manual massage therapy
359672|NCT00383500|E2|Reported Event|Manual Lymphatic Drainage (MLD)|Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment.
359673|NCT00383500|E1|Reported Event|Flexitouch Device|Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
359674|NCT00383552|B5|Baseline|Total|Total of all reporting groups
359675|NCT00383552|B4|Baseline|Placebo BID|Placebo twice daily (BID)
359676|NCT00383552|B3|Baseline|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
359677|NCT00383552|B2|Baseline|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
359678|NCT00383552|B1|Baseline|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
359679|NCT00383552|P4|Participant Flow|Placebo BID|Placebo twice daily (BID)
359680|NCT00383552|P3|Participant Flow|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
359681|NCT00383552|P2|Participant Flow|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
359682|NCT00383552|P1|Participant Flow|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
359683|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
359684|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
359685|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
359686|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
359687|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
359688|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
359689|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
359690|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
359691|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
359692|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
359693|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
359694|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
359695|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
359696|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
359697|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
359698|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
359699|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
359700|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
359701|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
359702|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
359703|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID).
359704|NCT00383552|O3|Outcome|F MDI 10 Mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID).
359705|NCT00383552|O2|Outcome|MF MDI 100 Mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID).
359706|NCT00383552|O1|Outcome|MF/F MDI 100/10 Mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID).
359707|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
359708|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
359709|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
359710|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
359711|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
359712|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
359713|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
359714|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
359715|NCT00383552|E5|Reported Event|PLACEBO|
359716|NCT00383552|E4|Reported Event|F MDI 10 MCG BID|
359717|NCT00383552|E3|Reported Event|MF MDI 100 MCG BID|
359718|NCT00383552|E2|Reported Event|MF/F MDI 100/10 MCG BID|
359763|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
359719|NCT00383552|E1|Reported Event|OL MF MDI 100 MCG BID|Open-label (OL) mometasone furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID). Participants received 2- to 3-weeks (approximately) of open-label run-in with MF MDI 100 mcg BID prior to the 26-week double-blind Treatment Period.
359720|NCT00383565|B1|Baseline|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
359721|NCT00383565|P1|Participant Flow|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
359722|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
359723|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
359724|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
359725|NCT00383565|E1|Reported Event|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
359726|NCT00383643|B4|Baseline|Total|Total of all reporting groups
359727|NCT00383643|B3|Baseline|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
359728|NCT00383643|B2|Baseline|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
359729|NCT00383643|B1|Baseline|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
359730|NCT00383643|P3|Participant Flow|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
359731|NCT00383643|P2|Participant Flow|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
359732|NCT00383643|P1|Participant Flow|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
359733|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
359734|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
359735|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
359736|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
359737|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
359738|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
359739|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
359740|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
359741|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
359742|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
359743|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
359744|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
359745|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
359746|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
359747|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
359748|NCT00383643|E3|Reported Event|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
359749|NCT00383643|E2|Reported Event|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
359750|NCT00383643|E1|Reported Event|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
359751|NCT00383721|B6|Baseline|Total|Total of all reporting groups
359752|NCT00383721|B5|Baseline|Placebo|Placebo MDI BID for 26 weeks.
359753|NCT00383721|B4|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
359754|NCT00383721|B3|Baseline|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
359755|NCT00383721|B2|Baseline|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
359756|NCT00383721|B1|Baseline|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
359757|NCT00383721|P5|Participant Flow|Placebo|Placebo MDI BID for 26 weeks.
359758|NCT00383721|P4|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
359759|NCT00383721|P3|Participant Flow|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
359760|NCT00383721|P2|Participant Flow|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
359761|NCT00383721|P1|Participant Flow|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
359764|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
359765|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
359766|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
359767|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
359768|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
359769|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
359770|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
359771|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
359772|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
359773|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
359774|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
359775|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
359776|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
359777|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
359778|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
359779|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
359780|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
359781|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
359782|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
359783|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
359784|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
359785|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
359786|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
359787|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
359788|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
359789|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
359790|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
359791|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
359792|NCT00383721|E5|Reported Event|Placebo|Placebo MDI BID for 26 weeks.
359793|NCT00383721|E4|Reported Event|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
359794|NCT00383721|E3|Reported Event|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
359795|NCT00383721|E2|Reported Event|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
359796|NCT00383721|E1|Reported Event|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
359797|NCT00383747|B3|Baseline|Total|Total of all reporting groups
359798|NCT00383747|B2|Baseline|Controls|
359799|NCT00383747|B1|Baseline|Non Smokers With Schizophrenia|
359800|NCT00383747|P4|Participant Flow|Controls: Placebo (V1) Then Nicotine Patch (V2)|Non-smoking adults without psychiatric illness received placebo patch then nicotine patch 14mg transdermal nicotine application
359801|NCT00383747|P3|Participant Flow|Controls: Nicotine Patch (V1) Then Placebo (V2)|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch
359802|NCT00383747|P2|Participant Flow|Nonsmokers w/Schizophr: Placebo (V1) Then Nicotine Patch (V2)|Non smokers with schizophrenia received Placebo patch application then Nicotine patch: 14mg transdermal nicotine
359803|NCT00383747|P1|Participant Flow|Non-smokers w/Schizophr: Nicotine Patch (V1) Then Placebo (V2)|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch
359804|NCT00383747|O4|Outcome|Control + Placebo|Non-smoking adults without psychiatric illness received placebo patch
359805|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
359806|NCT00383747|O2|Outcome|Nonsmokers With Schizophrenia + Placebo|Non smokers with schizophrenia received Placebo patch application
359807|NCT00383747|O1|Outcome|Non-smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
359808|NCT00383747|O4|Outcome|Control + Placebo|Non-smoking adults without psychiatric illness received placebo patch
359809|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
359810|NCT00383747|O2|Outcome|Nonsmokers With Schizophrenia + Placebo|Non smokers with schizophrenia received Placebo patch application
359811|NCT00383747|O1|Outcome|Non-smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
359812|NCT00383747|O4|Outcome|Control + Placebo|Non-smoking adults without psychiatric illness received placebo patch
359813|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
359814|NCT00383747|O2|Outcome|Nonsmokers With Schizophrenia +, Placebo|Non smokers with schizophrenia received Placebo patch application
359815|NCT00383747|O1|Outcome|Non-smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
359816|NCT00383747|O4|Outcome|Controls + Placebo Nicotine Patch|Non-smoking adults without psychiatric illness + placebo transdermal nicotine patch: 14mg transdermal nicotine application
359817|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness + transdermal nicotine patch: 14mg transdermal nicotine application
359818|NCT00383747|O2|Outcome|Non Smokers With Schizophrenia + Placebo Nicotine Patch|Non smokers with schizophrenia + Placebo transdermal nicotine patch: 14mg transdermal nicotine application
359819|NCT00383747|O1|Outcome|Non Smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication + transdermal nicotine patch: 14mg transdermal nicotine application
359820|NCT00383747|E2|Reported Event|Controls|
359821|NCT00383747|E1|Reported Event|Non Smokers With Schizophrenia|
359822|NCT00383760|B1|Baseline|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: 1.4mg/m2 given IV weekly day 1,8 every 21 days (1 cycle)."
359823|NCT00383760|P1|Participant Flow|E7389|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359824|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359825|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359826|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359827|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359828|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359829|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359830|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359831|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359832|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
361089|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
359833|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359834|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359835|NCT00383760|E1|Reported Event|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.
eribulin mesylate: Given IV"
359836|NCT00383786|B3|Baseline|Total|Total of all reporting groups
359837|NCT00383786|B2|Baseline|Placebo|sugar pill
359838|NCT00383786|B1|Baseline|GR205171|selective neurokinin-1 receptor antagonist
359839|NCT00383786|P2|Participant Flow|Placebo|sugar pill administered daily for a period of 8 weeks
359840|NCT00383786|P1|Participant Flow|GR205171|selective neurokinin-1 receptor antagonist, 5mg/day for a period of 8 weeks
359841|NCT00383786|O2|Outcome|Placebo|
359842|NCT00383786|O1|Outcome|GR205171|
359843|NCT00383786|E2|Reported Event|Placebo|sugar pill
359844|NCT00383786|E1|Reported Event|GR205171|selective neurokinin-1 receptor antagonist
359845|NCT00383942|B3|Baseline|Total|Total of all reporting groups
359846|NCT00383942|B2|Baseline|EASI|Patients randomized to this arm receive extra amniotic saline infusion via a catheter that is placed in the uterus
359847|NCT00383942|B1|Baseline|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
359848|NCT00383942|P2|Participant Flow|EASI|Patients randomized to this arm receive an extra amniotic saline infusion via catheter that is placed in the uterus
359849|NCT00383942|P1|Participant Flow|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
359850|NCT00383942|O2|Outcome|EASI|Patients randomized to this arm recieve extra amniotic saline infusion (EASI) via a catheter that is placed in the uterus
359851|NCT00383942|O1|Outcome|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
359852|NCT00383942|E2|Reported Event|EASI|Patients assigned to this arm received extra amniotic saline infusion via a catheter that is placed in the uterus
359853|NCT00383942|E1|Reported Event|Misoprostol|Patients assigned to this arm received 25 micrograms of misoprostol every 4 hours
359854|NCT00384033|B5|Baseline|Total|Total of all reporting groups
359855|NCT00384033|B4|Baseline|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
359856|NCT00384033|B3|Baseline|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359857|NCT00384033|B2|Baseline|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359858|NCT00384033|B1|Baseline|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359859|NCT00384033|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
359881|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359860|NCT00384033|P3|Participant Flow|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359861|NCT00384033|P2|Participant Flow|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359862|NCT00384033|P1|Participant Flow|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359863|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
359864|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359865|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359866|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359867|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
361090|NCT00386334|O1|Outcome|Placebo|Placebo tablets
359868|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359869|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359870|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359871|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
359872|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359873|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359874|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359875|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
359876|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359877|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359878|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359879|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
359880|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359971|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
359882|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359883|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
359884|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359885|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359886|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359887|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
359888|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359889|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359890|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359891|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
359892|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359893|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359894|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359895|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
359896|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359897|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359898|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359899|NCT00384033|E4|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
359900|NCT00384033|E3|Reported Event|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359901|NCT00384033|E2|Reported Event|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359902|NCT00384033|E1|Reported Event|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
359903|NCT00384059|B3|Baseline|Total|Total of all reporting groups
359972|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
359904|NCT00384059|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359905|NCT00384059|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359906|NCT00384059|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359907|NCT00384059|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
361091|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
359908|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359909|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359910|NCT00384059|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
359911|NCT00384059|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
359912|NCT00384059|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
359913|NCT00384059|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
359914|NCT00384059|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
359915|NCT00384059|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
359916|NCT00384059|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
359917|NCT00384059|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
359918|NCT00384059|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
359919|NCT00384059|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
359920|NCT00384059|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
359921|NCT00384059|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
359922|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
359923|NCT00384059|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
359924|NCT00384059|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
359925|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
359926|NCT00384059|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
359927|NCT00384059|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
359928|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359929|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359930|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359931|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359932|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359933|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359934|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359935|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359936|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359937|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359938|NCT00384059|O4|Outcome|7vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
359939|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
359940|NCT00384059|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
359941|NCT00384059|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
359942|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359943|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359944|NCT00384059|E8|Reported Event|7vPnC 6-Month Follow-up|Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit(assessment at 18 months of age, 6 months after the toddler dose).
359945|NCT00384059|E7|Reported Event|13vPnC 6-Month Follow-up|Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) & Meningococcal C Vaccine (Menitorix) at the 12-month visit (assessment at 18 months of age, 6 months after the toddler dose).
359946|NCT00384059|E6|Reported Event|7vPnC Toddler Series|Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
359947|NCT00384059|E5|Reported Event|13vPnC Toddler Series|Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
360105|NCT00384332|O2|Outcome|Arm 2- SOT|"regular olanzapine
regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
360220|NCT00384865|O2|Outcome|Aspirin Placebo|Placebo, taken orally, once a day for 6 months
359948|NCT00384059|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
359949|NCT00384059|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
359950|NCT00384059|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
359951|NCT00384059|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
359952|NCT00384085|B4|Baseline|Total|Total of all reporting groups
359953|NCT00384085|B3|Baseline|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
359954|NCT00384085|B2|Baseline|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
359955|NCT00384085|B1|Baseline|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
359956|NCT00384085|P3|Participant Flow|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
359957|NCT00384085|P2|Participant Flow|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
359958|NCT00384085|P1|Participant Flow|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
359959|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
359960|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
359961|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
359962|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
359963|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
359964|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
359965|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
359966|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
359967|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
359968|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
359969|NCT00384085|O1|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
359970|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
361038|NCT00386334|O1|Outcome|Placebo|Placebo tablets
359973|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
359974|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
359975|NCT00384085|O1|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
359976|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
359977|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
359978|NCT00384085|E3|Reported Event|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
359979|NCT00384085|E2|Reported Event|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
359980|NCT00384085|E1|Reported Event|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
359981|NCT00384176|B4|Baseline|Total|Total of all reporting groups
359982|NCT00384176|B3|Baseline|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359983|NCT00384176|B2|Baseline|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360106|NCT00384332|O1|Outcome|Arm 1- ODT|"Orally disintegrating olanzapine
orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
359984|NCT00384176|B1|Baseline|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359985|NCT00384176|P3|Participant Flow|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359986|NCT00384176|P2|Participant Flow|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359987|NCT00384176|P1|Participant Flow|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359988|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359989|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359990|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359991|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359992|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359993|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360094|NCT00384293|O1|Outcome|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
359994|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359995|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359996|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359997|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360107|NCT00384332|E2|Reported Event|Arm 2- SOT|"regular olanzapine
regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
360108|NCT00384332|E1|Reported Event|Arm 1- ODT|"Orally disintegrating olanzapine
orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
359998|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
359999|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360000|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360001|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360002|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360003|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360004|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360005|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360006|NCT00384176|E3|Reported Event|1Bevacizumab 5mg/kg|Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
360007|NCT00384176|E2|Reported Event|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360008|NCT00384176|E1|Reported Event|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
360009|NCT00384189|B5|Baseline|Total|Total of all reporting groups
360010|NCT00384189|B4|Baseline|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360261|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360011|NCT00384189|B3|Baseline|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360012|NCT00384189|B2|Baseline|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360013|NCT00384189|B1|Baseline|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360014|NCT00384189|P4|Participant Flow|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360109|NCT00384397|B4|Baseline|Total|Total of all reporting groups
360110|NCT00384397|B3|Baseline|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
360015|NCT00384189|P3|Participant Flow|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360016|NCT00384189|P2|Participant Flow|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360017|NCT00384189|P1|Participant Flow|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360018|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360019|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360020|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360021|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360022|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360023|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360024|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360025|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360026|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360027|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360028|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360095|NCT00384293|E3|Reported Event|Placebo (Postrandomization Period)|Patients who were randomized to placebo
360262|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
360029|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360030|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360031|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360032|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360033|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360034|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360035|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360036|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360037|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360038|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360039|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360040|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360041|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360042|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360043|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360044|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360045|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360046|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360096|NCT00384293|E2|Reported Event|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
360047|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360048|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360049|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360050|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360051|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360052|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360053|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360054|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360055|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360056|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360057|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360058|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360059|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360060|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360061|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360062|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360063|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360064|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360132|NCT00384670|P1|Participant Flow|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
360065|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360066|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360067|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360068|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360069|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360070|NCT00384189|E4|Reported Event|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360071|NCT00384189|E3|Reported Event|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360072|NCT00384189|E2|Reported Event|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360073|NCT00384189|E1|Reported Event|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
360074|NCT00384241|B3|Baseline|Total|Total of all reporting groups
360075|NCT00384241|B2|Baseline|Parents|African American and Caucasian parents, age 18-65.
360076|NCT00384241|B1|Baseline|Children|African American and Caucasian children age 15-19.
360077|NCT00384241|P2|Participant Flow|Parents|Buccal swabs from the Parents of 500 subjects in the children arm were collected and analyzed for genetic variations. Some parents submitted duplicate swabs if more than 1 child was represented in the 500 subjects.
360078|NCT00384241|P1|Participant Flow|Children|Genotyping and IL-6 levels of 500 children enrolled in two previous studies were collected in the current study. Other phenotype data: Baseline blood pressure, stress blood pressure, and recovery blood pressure; Baseline stress and recovery urinary sodium excretion that were collected in two previous studies were utilized in the current study.
360079|NCT00384241|O1|Outcome|Children|500 children age 15-19, self reported as African American or of European origin, healthy, non-smoker with normal blood pressure that participated in two previous studies
360080|NCT00384241|O1|Outcome|Children|500 children age 15-19, self reported as African American or of European origin, healthy, non-smoker with normal blood pressure that participated in two previous studies
360081|NCT00384241|E2|Reported Event|Parents|African American and Caucasian parents age 18 - 65
360082|NCT00384241|E1|Reported Event|Children|African American and Caucasian children age 15 - 19.
360083|NCT00384293|B3|Baseline|Total|Total of all reporting groups
360084|NCT00384293|B2|Baseline|Placebo (Postrandomization Period)|Patients who were randomized to placebo
360085|NCT00384293|B1|Baseline|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
360086|NCT00384293|P3|Participant Flow|Placebo (Postrandomization Period)|Patients who were randomized to placebo
360087|NCT00384293|P2|Participant Flow|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
360088|NCT00384293|P1|Participant Flow|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
360089|NCT00384293|O3|Outcome|Placebo (Postrandomization Period)|Patients who were randomized to placebo
360090|NCT00384293|O2|Outcome|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
360091|NCT00384293|O1|Outcome|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
360092|NCT00384293|O3|Outcome|Placebo (Postrandomization Period)|Patients who were randomized to placebo
360093|NCT00384293|O2|Outcome|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
360263|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360264|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
360097|NCT00384293|E1|Reported Event|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
360098|NCT00384332|B3|Baseline|Total|Total of all reporting groups
360099|NCT00384332|B2|Baseline|Arm 2|"regular olanzapine
regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
360100|NCT00384332|B1|Baseline|Arm 1|"Orally disintegrating olanzapine
orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
360101|NCT00384332|P2|Participant Flow|Arm 2- SOT|"regular olanzapine
regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
360102|NCT00384332|P1|Participant Flow|Arm 1- ODT|"Orally disintegrating olanzapine
orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
360103|NCT00384332|O2|Outcome|Arm 2|"regular olanzapine
regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
360104|NCT00384332|O1|Outcome|Arm 1|"Orally disintegrating olanzapine
orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
360221|NCT00384865|O1|Outcome|Aspirin 81 mg|Aspirin 81 mg, taken orally, once a day for 6 months
360111|NCT00384397|B2|Baseline|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
360112|NCT00384397|B1|Baseline|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
360113|NCT00384397|P3|Participant Flow|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
360114|NCT00384397|P2|Participant Flow|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
360115|NCT00384397|P1|Participant Flow|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
360116|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
360117|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
360118|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
360119|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
360120|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
360121|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
360122|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
360123|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
360124|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
360125|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
360126|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
360127|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
360128|NCT00384397|E3|Reported Event|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
360129|NCT00384397|E2|Reported Event|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
360130|NCT00384397|E1|Reported Event|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
360131|NCT00384670|B1|Baseline|Dengue Vaccine and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
360265|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
361039|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
360133|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
360134|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
360135|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
360136|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
360137|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
360138|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
360139|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
360140|NCT00384670|E1|Reported Event|Dengue Vaccine and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
360141|NCT00378508|B3|Baseline|Total|Total of all reporting groups
360142|NCT00378508|B2|Baseline|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360175|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360143|NCT00378508|B1|Baseline|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360144|NCT00378508|P2|Participant Flow|Teplizumab Infusion (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360145|NCT00378508|P1|Participant Flow|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360146|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360147|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360148|NCT00378508|O2|Outcome|Saline Infusion (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360149|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360150|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360151|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360152|NCT00378508|O2|Outcome|Saline Infusion (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360153|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360154|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360155|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360156|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360157|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360158|NCT00378508|E2|Reported Event|Teplizumab Infusion (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360159|NCT00378508|E1|Reported Event|Saline Infusions (Placebo)|The course of a saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
360160|NCT00378534|B1|Baseline|Hematologic Survival Using Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse at day +200.
360161|NCT00378534|P1|Participant Flow|CD34 Selection|"T cell depletion
Miltenyi Clinimax CD34 Reagent System: T cell depletion"
360204|NCT00384813|P1|Participant Flow|1: Home-based Family Intervention|"Home-based family intervention
Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
360266|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360162|NCT00378534|O1|Outcome|Hematologic Survival Using Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse at day +200.
360163|NCT00378534|E1|Reported Event|Transplant Recipients|"T cell depletion
Miltenyi Clinimax CD34 Reagent System: T cell depletion"
360164|NCT00378560|B3|Baseline|Total|Total of all reporting groups
360165|NCT00378560|B2|Baseline|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360166|NCT00378560|B1|Baseline|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360167|NCT00378560|P2|Participant Flow|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360168|NCT00378560|P1|Participant Flow|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360169|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360170|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360171|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360172|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360173|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360174|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360176|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360177|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360178|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360179|NCT00378560|E2|Reported Event|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360180|NCT00378560|E1|Reported Event|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
360181|NCT00378573|B1|Baseline|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
360182|NCT00378573|P1|Participant Flow|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
360183|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
360184|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
360185|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
360186|NCT00378573|E1|Reported Event|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
360187|NCT00378599|B1|Baseline|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
360188|NCT00378599|P1|Participant Flow|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
360189|NCT00378599|O1|Outcome|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
360190|NCT00378599|E1|Reported Event|Pegylated Interferon Alfa-2b and Ribavirin|
360191|NCT00384748|B3|Baseline|Total|Total of all reporting groups
360192|NCT00384748|B2|Baseline|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.
Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.
Usual care: Routine VA care."
360205|NCT00384813|O2|Outcome|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)
Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
360267|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
360268|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360193|NCT00384748|B1|Baseline|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.
The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
360194|NCT00384748|P2|Participant Flow|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.
Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.
Usual care: Routine VA care."
360215|NCT00384865|P3|Participant Flow|Placebo + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months
Placebo: Placebo, taken orally, once a day for 6 months"
360216|NCT00384865|P2|Participant Flow|Aspirin 81 mg + Placebo|"Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months
Placebo: Placebo, taken orally, once a day for 6 months"
360217|NCT00384865|P1|Participant Flow|Aspirin 81 mg + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months
Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months"
360218|NCT00384865|O4|Outcome|Simvastatin Placebo|Placebo, taken orally, once a day for 6 months
360195|NCT00384748|P1|Participant Flow|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.
The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
360196|NCT00384748|O2|Outcome|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.
Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.
Usual care: Routine VA care."
360197|NCT00384748|O1|Outcome|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.
The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
360198|NCT00384748|E2|Reported Event|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.
Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.
Usual care: Routine VA care."
360199|NCT00384748|E1|Reported Event|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.
The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
360200|NCT00384813|B3|Baseline|Total|Total of all reporting groups
360201|NCT00384813|B2|Baseline|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)
Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
360202|NCT00384813|B1|Baseline|1: Home-based Family Intervention|"Home-based family intervention
Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
360203|NCT00384813|P2|Participant Flow|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)
Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
360260|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
361040|NCT00386334|O1|Outcome|Placebo|Placebo tablets
360206|NCT00384813|O1|Outcome|1: Home-based Family Intervention|"Home-based family intervention
Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
360207|NCT00384813|E2|Reported Event|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)
Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
360208|NCT00384813|E1|Reported Event|1: Home-based Family Intervention|"Home-based family intervention
Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
360209|NCT00384865|B5|Baseline|Total|Total of all reporting groups
360210|NCT00384865|B4|Baseline|Placebo + Placebo|Placebo: Placebo, taken orally, once a day for 6 months
360211|NCT00384865|B3|Baseline|Placebo + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months
Placebo: Placebo, taken orally, once a day for 6 months"
360212|NCT00384865|B2|Baseline|Aspirin 81 mg + Placebo|"Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months
Placebo: Placebo, taken orally, once a day for 6 months"
360213|NCT00384865|B1|Baseline|Aspirin 81 mg + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months
Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months"
360214|NCT00384865|P4|Participant Flow|Placebo + Placebo|Placebo: Placebo, taken orally, once a day for 6 months
360222|NCT00384865|O4|Outcome|Simvastatin Placebo|Placebo, taken orally, once a day for 6 months
360223|NCT00384865|O3|Outcome|Simvastatin 40 mg|Simvastatin 40 mg, taken orally, once a day for 6 months
360224|NCT00384865|O2|Outcome|Aspirin Placebo|Placebo, taken orally, once a day for 6 months
360225|NCT00384865|O1|Outcome|Aspirin 81 mg|Aspirin 81 mg, taken orally, once a day for 6 months
360226|NCT00384865|O4|Outcome|Simvastatin Placebo|Placebo, taken orally, once a day for 6 months
360227|NCT00384865|O3|Outcome|Simvastatin 40 mg|Simvastatin 40 mg, taken orally, once a day for 6 months
360228|NCT00384865|O2|Outcome|Aspirin Placebo|Placebo, taken orally, once a day for 6 months
360229|NCT00384865|O1|Outcome|Aspirin 81 mg|Aspirin 81 mg, taken orally, once a day for 6 months
360230|NCT00384865|E4|Reported Event|Simvastatin Placebo|Placebo, taken orally, once a day for 6 months
360231|NCT00384865|E3|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg, taken orally, once a day for 6 months
360232|NCT00384865|E2|Reported Event|Aspirin Placebo|Placebo, taken orally, once a day for 6 months
360233|NCT00384865|E1|Reported Event|Aspirin 81 mg|Aspirin 81 mg, taken orally, once a day for 6 months
360234|NCT00384930|B6|Baseline|Total|Total of all reporting groups
360235|NCT00384930|B5|Baseline|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
360236|NCT00384930|B4|Baseline|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360237|NCT00384930|B3|Baseline|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
360238|NCT00384930|B2|Baseline|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360239|NCT00384930|B1|Baseline|Placebo|placebo tablet by mouth once a day for twelve weeks
360240|NCT00384930|P5|Participant Flow|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
360241|NCT00384930|P4|Participant Flow|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360242|NCT00384930|P3|Participant Flow|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
360243|NCT00384930|P2|Participant Flow|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360244|NCT00384930|P1|Participant Flow|Placebo|placebo tablet by mouth once a day for twelve weeks
360245|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
360246|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360247|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
360248|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360249|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
360250|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
360251|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360252|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
360253|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360254|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
360255|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
360256|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360257|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
360258|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360259|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
360269|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
360270|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
360271|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360272|NCT00384930|O3|Outcome|5.0 mg Tadalafil|5.0 mg tadalafil tablet by mouth once a day for twelve weeks
360273|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360274|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
360275|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
360276|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360277|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
360278|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360279|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
360280|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
360281|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360282|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
360283|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360284|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
360285|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
360286|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360287|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
360288|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360289|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
360290|NCT00384930|O2|Outcome|5 mg Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
360291|NCT00384930|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360292|NCT00384930|E5|Reported Event|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
361092|NCT00386334|O1|Outcome|Placebo|Placebo tablets
360293|NCT00384930|E4|Reported Event|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
360294|NCT00384930|E3|Reported Event|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
360295|NCT00384930|E2|Reported Event|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
360296|NCT00384930|E1|Reported Event|Placebo|placebo tablet by mouth once a day for twelve weeks
360297|NCT00384956|B1|Baseline|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360298|NCT00384956|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360299|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360300|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360301|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360302|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360303|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360304|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360305|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360306|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360457|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
361041|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
360307|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360308|NCT00384956|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
360309|NCT00385515|B3|Baseline|Total|Total of all reporting groups
360310|NCT00385515|B2|Baseline|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
360311|NCT00385515|B1|Baseline|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
360312|NCT00385515|P2|Participant Flow|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
360313|NCT00385515|P1|Participant Flow|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
360314|NCT00385515|O2|Outcome|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
360315|NCT00385515|O1|Outcome|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
360316|NCT00385515|O2|Outcome|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
360317|NCT00385515|O1|Outcome|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
360318|NCT00385541|B3|Baseline|Total|Total of all reporting groups
360319|NCT00385541|B2|Baseline|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
360320|NCT00385541|B1|Baseline|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
360321|NCT00385541|P2|Participant Flow|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
360322|NCT00385541|P1|Participant Flow|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
360323|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
360324|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
360325|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
360326|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
360327|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
360328|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
360329|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
360330|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
360331|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
360332|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
360333|NCT00385541|E2|Reported Event|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
360334|NCT00385541|E1|Reported Event|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
360335|NCT00385580|B3|Baseline|Total|Total of all reporting groups
360336|NCT00385580|B2|Baseline|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360337|NCT00385580|B1|Baseline|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360338|NCT00385580|P2|Participant Flow|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360339|NCT00385580|P1|Participant Flow|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360458|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360340|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (X dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360341|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (X dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360342|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (50 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360343|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (50 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360432|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
360433|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
361093|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
360344|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (50 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360345|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (50 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360346|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (70 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360347|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (70 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360348|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (70 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360349|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (70 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360350|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (70 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360351|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (70 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360459|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360460|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360635|NCT00385736|P3|Participant Flow|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
360352|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360353|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (100 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360354|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (100 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360355|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360356|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (100 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360357|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (100 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360358|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360359|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360360|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360361|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360362|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360363|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360461|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360462|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360364|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360365|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360366|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360367|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360368|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360369|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360370|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360371|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360372|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360373|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360374|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360375|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360463|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360464|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360376|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360377|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360378|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360379|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360380|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360381|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360382|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360383|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360384|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360385|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360386|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360387|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360465|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360466|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
361042|NCT00386334|O1|Outcome|Placebo|Placebo tablets
360388|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360389|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360390|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360391|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360392|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360393|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360394|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360395|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360396|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360397|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360398|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360399|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360467|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360468|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360400|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360401|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360402|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360403|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360404|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360405|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360406|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360407|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360408|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360409|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360410|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360411|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360469|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360470|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360412|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360413|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360414|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360415|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360416|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360417|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360418|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360419|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360420|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360421|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360422|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360423|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360471|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360472|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
361043|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
360424|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360425|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
360426|NCT00385580|E1|Reported Event|Dasatinib|All treated participants
360427|NCT00385593|B3|Baseline|Total|Total of all reporting groups
360428|NCT00385593|B2|Baseline|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
360429|NCT00385593|B1|Baseline|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
360430|NCT00385593|P2|Participant Flow|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
360431|NCT00385593|P1|Participant Flow|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
361094|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361095|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
360434|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
360435|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
360436|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
360437|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
360438|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
360439|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
360440|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
360441|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
360442|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
360443|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
360444|NCT00385593|E2|Reported Event|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
360445|NCT00385593|E1|Reported Event|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
360446|NCT00385671|B4|Baseline|Total|Total of all reporting groups
360447|NCT00385671|B3|Baseline|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360448|NCT00385671|B2|Baseline|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360449|NCT00385671|B1|Baseline|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360450|NCT00385671|P3|Participant Flow|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360451|NCT00385671|P2|Participant Flow|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360452|NCT00385671|P1|Participant Flow|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360453|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360454|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360455|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360456|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
361044|NCT00386334|O1|Outcome|Placebo|Placebo tablets
360473|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360474|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360475|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360476|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360477|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360478|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360479|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360480|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360481|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360482|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360483|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360484|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360485|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360486|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360487|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360488|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360489|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360490|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360491|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360492|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360493|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360494|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360495|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360496|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360497|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360498|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360499|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360500|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360501|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360502|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360503|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360504|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360505|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360506|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360943|NCT00386152|B2|Baseline|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
360507|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360508|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360509|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360510|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360511|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360512|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360513|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360514|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360515|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360516|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360517|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360518|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360519|NCT00385671|O1|Outcome|Ordinary Coefficient|Beta-coefficient from regression analyses estimating direct and indirect treatment effects expressed in the observed scale of measurement of the dependent variable.
360520|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360521|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360522|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360523|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360524|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360525|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360526|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360527|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360528|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360529|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360530|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360531|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360532|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360533|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360534|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360535|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360536|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360537|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360538|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360539|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360540|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360636|NCT00385736|P2|Participant Flow|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
360541|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360542|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360543|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360544|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360545|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360546|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360547|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360548|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360549|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360550|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360551|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360552|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360553|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360554|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360555|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360556|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360557|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360558|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360559|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360560|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360561|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360562|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360563|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360564|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360565|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360566|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360567|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360568|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360569|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360570|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360571|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360572|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360573|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360574|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360575|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360576|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360577|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360578|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360579|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360580|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360581|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360582|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360583|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360584|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360585|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360586|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360587|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360588|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360589|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360590|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360591|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360592|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360593|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360594|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360595|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360596|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360597|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360598|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360599|NCT00385671|O1|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360600|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360601|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360602|NCT00385671|E3|Reported Event|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
360603|NCT00385671|E2|Reported Event|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
360604|NCT00385671|E1|Reported Event|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
360605|NCT00385684|B1|Baseline|ALL STUDY PARTICIPANTS|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.
Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
360634|NCT00385736|B1|Baseline|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360606|NCT00385684|P2|Participant Flow|A2 THEN A1 Then Phase B|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.
Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
360607|NCT00385684|P1|Participant Flow|A1 and Then A2 Then Phase B|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.
Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
360608|NCT00385684|O1|Outcome|Phase B: Open Label|Those participants for whom the study medication was tolerated during Phase A (i.e., the closed label, double-blind phase of the trial) entered a six-week open-label phase.
360650|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360651|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
361096|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361097|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
360609|NCT00385684|O2|Outcome|Placebo Comparator: A2|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.
Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
360610|NCT00385684|O1|Outcome|Experimental: A1|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.
Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
360611|NCT00385684|E1|Reported Event|ALL STUDY PARTICIPANTS|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.
Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
360612|NCT00385723|B4|Baseline|Total|Total of all reporting groups
360613|NCT00385723|B3|Baseline|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
360614|NCT00385723|B2|Baseline|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
360615|NCT00385723|B1|Baseline|Placebo|Placebo : matching placebo capsule daily for 4 months
360616|NCT00385723|P3|Participant Flow|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
360617|NCT00385723|P2|Participant Flow|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
360618|NCT00385723|P1|Participant Flow|Placebo|Placebo : matching placebo capsule daily for 4 months
360619|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
360620|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
360621|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
360622|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
360623|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
360624|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
360625|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
360626|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
360627|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
360628|NCT00385723|E3|Reported Event|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
360629|NCT00385723|E2|Reported Event|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
360630|NCT00385723|E1|Reported Event|Placebo|Placebo : matching placebo capsule daily for 4 months
360631|NCT00385736|B4|Baseline|Total|Total of all reporting groups
360632|NCT00385736|B3|Baseline|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
360633|NCT00385736|B2|Baseline|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
361023|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
360637|NCT00385736|P1|Participant Flow|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360638|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
360639|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
360640|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
360641|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
360642|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
360643|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
360644|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
360645|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
360646|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
360647|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
360648|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360649|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
360652|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360653|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
360654|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360655|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
360656|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360657|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
360658|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360659|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
360660|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360661|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
360662|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360663|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
360664|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360665|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
360666|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360667|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
360668|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360669|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
360670|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360671|NCT00385736|O3|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
360672|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
360802|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360673|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
360674|NCT00385736|E4|Reported Event|Any Adalimumab|Treatment group received at least 1 dose of adalimumab during the study. Adverse events include those reported from the first dose of adalimumab during the double-blind or open-label period.
360675|NCT00385736|E3|Reported Event|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.
360676|NCT00385736|E2|Reported Event|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.
360677|NCT00385736|E1|Reported Event|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6. Adverse events include those reported prior to dosing at Week 8.
360678|NCT00385762|B1|Baseline|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
360679|NCT00385762|P1|Participant Flow|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
360680|NCT00385762|O1|Outcome|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
360681|NCT00385762|O1|Outcome|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
360682|NCT00385762|O1|Outcome|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
360909|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360683|NCT00385762|O1|Outcome|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
360684|NCT00385762|E1|Reported Event|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
360685|NCT00385801|B3|Baseline|Total|Total of all reporting groups
360686|NCT00385801|B2|Baseline|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
360687|NCT00385801|B1|Baseline|Placebo|Identical placebo tablets and injections
360688|NCT00385801|P2|Participant Flow|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
360689|NCT00385801|P1|Participant Flow|Placebo|Identical placebo tablets and injections
360690|NCT00385801|O2|Outcome|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
360691|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
360692|NCT00385801|O2|Outcome|Risperidone|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
360693|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
360694|NCT00385801|O2|Outcome|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
360695|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
360696|NCT00385801|O2|Outcome|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
360697|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
360698|NCT00385801|E2|Reported Event|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
360699|NCT00385801|E1|Reported Event|Placebo|Identical placebo tablets and injections
360700|NCT00385827|B4|Baseline|Total|Total of all reporting groups
360701|NCT00385827|B3|Baseline|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360702|NCT00385827|B2|Baseline|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360703|NCT00385827|B1|Baseline|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
360704|NCT00385827|P3|Participant Flow|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360705|NCT00385827|P2|Participant Flow|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360803|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
361024|NCT00386334|O1|Outcome|Placebo|Placebo tablets
360706|NCT00385827|P1|Participant Flow|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
360707|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360708|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360709|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
360710|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360711|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360712|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
360713|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360714|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360715|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
360716|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360717|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360718|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
360898|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360719|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360720|NCT00385827|O1|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360721|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
360722|NCT00385827|E3|Reported Event|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
361098|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361099|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
360723|NCT00385827|E2|Reported Event|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
360724|NCT00385827|E1|Reported Event|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
360725|NCT00385840|B3|Baseline|Total|Total of all reporting groups
360726|NCT00385840|B2|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360727|NCT00385840|B1|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360728|NCT00385840|P2|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360729|NCT00385840|P1|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360730|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360731|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360732|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360733|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360734|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360735|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360736|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360804|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360941|NCT00386152|B4|Baseline|Total|Total of all reporting groups
360737|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360738|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360739|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360740|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360741|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360742|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360910|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360743|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360744|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360745|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360746|NCT00385840|E2|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360747|NCT00385840|E1|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
360748|NCT00385918|B3|Baseline|Total|Total of all reporting groups
360749|NCT00385918|B2|Baseline|Home Stretching Then Lokomat Exercise|"Patients will participate in a home stretching program for 3 months. They will then be crossed over to Lokomat treatment for an additional 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm."
360750|NCT00385918|B1|Baseline|Lokomat Exercise|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360751|NCT00385918|P3|Participant Flow|Baseline and Feasibility Testing|All subjects were screened and underwent baseline testing prior to randomization into either the Lokomat training or the Home stretching then Lokomat training group.
360752|NCT00385918|P2|Participant Flow|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.
After 3 months the participants will be switched to a 3 month period of Lokomat training the same as that offered to the patients randomized to the Lokomat Training arm of the study."
360753|NCT00385918|P1|Participant Flow|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360754|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.
The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
360755|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360805|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360806|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
361025|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
360756|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.
The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
360757|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360758|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.
The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
360814|NCT00385944|E5|Reported Event|Prasugrel 10 mg - Crossover From Clopidogrel 150 mg|Once daily MD of prasugrel 10 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of clopidogrel 150 mg and 100 mg aspirin during the 1st MD period.
361100|NCT00386334|O1|Outcome|Placebo|Placebo tablets
360759|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360760|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.
The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
360761|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360762|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.
The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
360763|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360764|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.
The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
360765|NCT00385918|O1|Outcome|Lokomat Treatment|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360766|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.
The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
360767|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360768|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.
The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
360769|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360863|NCT00386009|E2|Reported Event|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360770|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.
The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
360771|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360772|NCT00385918|E2|Reported Event|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.
Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.This group will switch to the 3-month robotic intervention after completing the home-based training program."
360907|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360773|NCT00385918|E1|Reported Event|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
360774|NCT00385944|B3|Baseline|Total|Total of all reporting groups
360775|NCT00385944|B2|Baseline|Clopidogrel/Prasugrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
360776|NCT00385944|B1|Baseline|Prasugrel/Clopidogrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
360777|NCT00385944|P3|Participant Flow|Loading Dose|Clopidogrel 900-mg Loading Dose (a single or cumulative dose)
360778|NCT00385944|P2|Participant Flow|Clopidogrel/Prasugrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
360779|NCT00385944|P1|Participant Flow|Prasugrel/Clopidogrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
360780|NCT00385944|O1|Outcome|Intent-to-treat Population|Both clopidogrel and prasugrel combined population
360781|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360782|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360783|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360784|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360785|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD) or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
360786|NCT00385944|O1|Outcome|Prasugrel/Clopidogrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
360787|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD) or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
360788|NCT00385944|O1|Outcome|Prasugrel/Clopidogrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
360789|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD)or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
360790|NCT00385944|O1|Outcome|Prasugrel/Clopidgrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
360791|NCT00385944|O1|Outcome|Clopidogrel 900 mg|Clopidogrel 900 mg LD (a single or cumulative dose)
360792|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360793|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360794|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360795|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360796|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360797|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360798|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360799|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360800|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360801|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360864|NCT00386009|E1|Reported Event|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360807|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360808|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360809|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360810|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360811|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360812|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
360813|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
360908|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360815|NCT00385944|E4|Reported Event|Clopidogrel 150 mg - Crossover From Prasugrel 10 mg|Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of prasugrel 10 mg and 100 mg aspirin during the 1st MD period.
360816|NCT00385944|E3|Reported Event|Clopidogrel 150 mg - 1st MD|Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days.
360817|NCT00385944|E2|Reported Event|Prasugrel 10 mg - 1st MD|Once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days.
360818|NCT00385944|E1|Reported Event|Clopidogrel 900 mg LD|One time oral loading dose (LD) of 900-mg clopidogrel
360819|NCT00385996|B1|Baseline|Erlotinib|Erlotinib 150 mg po daily
360820|NCT00385996|P1|Participant Flow|Erlotinib|Erlotinib 150 mg po daily.
360821|NCT00385996|O1|Outcome|Erlotinib|Erlotinib 150 mg po daily
360822|NCT00385996|O1|Outcome|Erlotinib|Erlotinib 150 mg po daily
360823|NCT00385996|E1|Reported Event|Erlotinib|Erlotinib 150 mg po daily.
360824|NCT00386009|B3|Baseline|Total|Total of all reporting groups
360825|NCT00386009|B2|Baseline|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360826|NCT00386009|B1|Baseline|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360827|NCT00386009|P2|Participant Flow|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360828|NCT00386009|P1|Participant Flow|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360829|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360830|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360831|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360832|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360833|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360834|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360835|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360836|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360837|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360838|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360839|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360840|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360841|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360842|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360843|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360844|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360845|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360846|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360847|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360848|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360849|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360850|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360851|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360852|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360853|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360854|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360855|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360856|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360857|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360858|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360859|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360860|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360861|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
360862|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
360865|NCT00386022|B3|Baseline|Total|Total of all reporting groups
360866|NCT00386022|B2|Baseline|Older PMW|"Postmenopausal women (PMW) 70-80 years old receiving the following series of treatments:
A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
360867|NCT00386022|B1|Baseline|Younger PMW|"Postmenopausal women (PMW) 45-55 years old receiving the following series of treatments:
A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
360868|NCT00386022|P2|Participant Flow|Older PMW|"Postmenopausal women (PMW) 70-80 years old receiving the following series of treatments:
A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
360869|NCT00386022|P1|Participant Flow|Younger PMW|"Postmenopausal women (PMW) 45-55 years old receiving the following series of treatments:
A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
361101|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
360870|NCT00386022|O2|Outcome|Older Postmenopausal Women|"Postmenopausal women aged 70-80 years studied after 1 month of transdermal estrogen 0.05 mg/day using the following interventions:
A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
360871|NCT00386022|O1|Outcome|Young Postmenopausal Women|"Postmenopausal women aged 45-55 years studied after 1 month of transdermal estrogen 0.05 mg/day using the following interventions:
A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
360872|NCT00386022|O2|Outcome|Older PMW|"Postmenopausal women aged 70-80 years studied at baseline using the following interventions:
A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
360873|NCT00386022|O1|Outcome|Younger PMW|"Postmenopausal women aged 45-55 years studied at baseline using the following interventions:
A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
360874|NCT00386022|E2|Reported Event|Older PMW|"Postmenopausal women aged 70-80 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:
A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
360875|NCT00386022|E1|Reported Event|Younger PMW|"Postmenopausal women aged 45-55 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:
A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
360876|NCT00386100|B3|Baseline|Total|Total of all reporting groups
360877|NCT00386100|B2|Baseline|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360878|NCT00386100|B1|Baseline|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360879|NCT00386100|P2|Participant Flow|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360880|NCT00386100|P1|Participant Flow|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360881|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360882|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360883|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360884|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360885|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360886|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360887|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360888|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360889|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360890|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360891|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360892|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360893|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360894|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360895|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360896|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360897|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360942|NCT00386152|B3|Baseline|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
360899|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360900|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360901|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360902|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360903|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360904|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360905|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360906|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360958|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
360911|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360912|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360913|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360914|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360915|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360916|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360917|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360918|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360919|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360920|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360921|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360922|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360923|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360924|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360925|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360926|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360927|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360928|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360929|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360930|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360931|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360932|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360933|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360934|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360935|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360936|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360937|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360938|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360939|NCT00386100|E2|Reported Event|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
360940|NCT00386100|E1|Reported Event|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
360944|NCT00386152|B1|Baseline|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
360945|NCT00386152|P3|Participant Flow|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
360946|NCT00386152|P2|Participant Flow|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
360947|NCT00386152|P1|Participant Flow|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
360948|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
360949|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
360950|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
360951|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
360952|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
360953|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
360954|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
360955|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
360956|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
360957|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
360959|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
360960|NCT00386152|E3|Reported Event|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
360961|NCT00386152|E2|Reported Event|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
360962|NCT00386152|E1|Reported Event|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
360963|NCT00386243|B3|Baseline|Total|Total of all reporting groups
360964|NCT00386243|B2|Baseline|Arm 2|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy"
360965|NCT00386243|B1|Baseline|Arm 1|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
360966|NCT00386243|P2|Participant Flow|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy"
360967|NCT00386243|P1|Participant Flow|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
360968|NCT00386243|O2|Outcome|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy"
360969|NCT00386243|O1|Outcome|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
360970|NCT00386243|O2|Outcome|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy"
360971|NCT00386243|O1|Outcome|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
360972|NCT00386243|E2|Reported Event|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
Co-Analgesic Therapy"
360973|NCT00386243|E1|Reported Event|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
360974|NCT00386256|B5|Baseline|Total|Total of all reporting groups
360975|NCT00386256|B4|Baseline|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
360976|NCT00386256|B3|Baseline|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
360977|NCT00386256|B2|Baseline|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
360978|NCT00386256|B1|Baseline|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
360979|NCT00386256|P4|Participant Flow|Telephone Inpatient|
360980|NCT00386256|P3|Participant Flow|Health Buddy Inpatient|
360981|NCT00386256|P2|Participant Flow|Telephone Outpatient|
361070|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361071|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361072|NCT00386334|O1|Outcome|Placebo|Placebo tablets
360982|NCT00386256|P1|Participant Flow|Health Buddy Outpatient|Health Buddy(R), Home telehealth technology : Exercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety.
360983|NCT00386256|O4|Outcome|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
360984|NCT00386256|O3|Outcome|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
360985|NCT00386256|O2|Outcome|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
360986|NCT00386256|O1|Outcome|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
360987|NCT00386256|O4|Outcome|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
360988|NCT00386256|O3|Outcome|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
360989|NCT00386256|O2|Outcome|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
360990|NCT00386256|O1|Outcome|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
360991|NCT00386256|E4|Reported Event|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
360992|NCT00386256|E3|Reported Event|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
360993|NCT00386256|E2|Reported Event|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
360994|NCT00386256|E1|Reported Event|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
360995|NCT00386308|B3|Baseline|Total|Total of all reporting groups
360996|NCT00386308|B2|Baseline|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
360997|NCT00386308|B1|Baseline|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
360998|NCT00386308|P2|Participant Flow|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
360999|NCT00386308|P1|Participant Flow|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
361000|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
361001|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
361002|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
361003|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
361004|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
361005|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
361006|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
361007|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
361008|NCT00386308|E2|Reported Event|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
361009|NCT00386308|E1|Reported Event|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
361010|NCT00386334|B3|Baseline|Total|Total of all reporting groups
361011|NCT00386334|B2|Baseline|Eszopiclone|Eszopiclone 2 mg tablets
361012|NCT00386334|B1|Baseline|Placebo|Placebo tablets
361013|NCT00386334|P2|Participant Flow|Eszopiclone|Eszopiclone 2 mg tablets
361014|NCT00386334|P1|Participant Flow|Placebo|Placebo tablets
361015|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361016|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361017|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361018|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361019|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361020|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361021|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361022|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361045|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361046|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361047|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361048|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361049|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361050|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361051|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361052|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361053|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361054|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361055|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361056|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361057|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361058|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361059|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361060|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361061|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361062|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361063|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361064|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361065|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361066|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361067|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361068|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361069|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361102|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361103|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361104|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361105|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361106|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361107|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361108|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361109|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361110|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361111|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361112|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361113|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361114|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361115|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361116|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361117|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361118|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361119|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361120|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361121|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361122|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361123|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361124|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361125|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361126|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361127|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361128|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361129|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361130|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361131|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361132|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361133|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361134|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361135|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361136|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361137|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361138|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361139|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361140|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361141|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361142|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361143|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361144|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361145|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361146|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361147|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361148|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361149|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361150|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361151|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
361152|NCT00386334|O1|Outcome|Placebo|Placebo tablets
361153|NCT00386334|E2|Reported Event|Eszopiclone|Eszopiclone 2 mg tablets
361154|NCT00386334|E1|Reported Event|Placebo|Placebo tablets
361155|NCT00386360|B3|Baseline|Total|Total of all reporting groups
361156|NCT00386360|B2|Baseline|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361157|NCT00386360|B1|Baseline|Placebo|Placebo, 1 tablet weekly on the same day
361158|NCT00386360|P2|Participant Flow|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361159|NCT00386360|P1|Participant Flow|Placebo|Placebo, 1 tablet weekly on the same day
361160|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361161|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361162|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361163|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361164|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361165|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361166|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361167|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361168|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361169|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361170|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361171|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361172|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361173|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361174|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361175|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361176|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361177|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361178|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361179|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361180|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361181|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361182|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361183|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361184|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361185|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361186|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361187|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
361188|NCT00386360|E2|Reported Event|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
361189|NCT00386360|E1|Reported Event|Placebo|Placebo, 1 tablet weekly on the same day
361190|NCT00386425|B4|Baseline|Total|Total of all reporting groups
361191|NCT00386425|B3|Baseline|Randomized Non-ITT Population|
361192|NCT00386425|B2|Baseline|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
361193|NCT00386425|B1|Baseline|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
361194|NCT00386425|P3|Participant Flow|Randomized Non-ITT Population|Participants were randomized to either the Standard or Alternative Therapy and received 24 mcg/kg/hr during the first 24 hours (common therapy period); however, they did not continue on to receive the actual randomized therapy.
361195|NCT00386425|P2|Participant Flow|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
361196|NCT00386425|P1|Participant Flow|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
361197|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
361198|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
361199|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
361200|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
361201|NCT00386425|O2|Outcome|Did Not Normalize Protein C|
361202|NCT00386425|O1|Outcome|Normalized Protein C|
361203|NCT00386425|O4|Outcome|Alternative Therapy - Moderate Deficiency|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
361204|NCT00386425|O3|Outcome|Alternative Therapy - Severe Deficiency|Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
361205|NCT00386425|O2|Outcome|Standard Therapy - Moderate Deficiency|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
361206|NCT00386425|O1|Outcome|Standard Therapy - Severe Deficiency|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
361207|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
361208|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
361209|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
361210|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
361211|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
361212|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
361213|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
361214|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
361215|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
361216|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
361217|NCT00386425|E2|Reported Event|Alternative Therapy|Participants assigned to alternative therapy (Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours) who received any amount of study drug.
361218|NCT00386425|E1|Reported Event|Standard Therapy|Participants assigned to standard therapy (24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours) who received any amount of study drug.
361219|NCT00386477|B3|Baseline|Total|Total of all reporting groups
361220|NCT00386477|B2|Baseline|Control|No vaginal cleansing or sham wash performed.
361221|NCT00386477|B1|Baseline|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
361222|NCT00386477|P2|Participant Flow|Control|No vaginal cleansing or sham wash performed.
361223|NCT00386477|P1|Participant Flow|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
361224|NCT00386477|O2|Outcome|Control|No vaginal cleansing or sham wash performed.
361225|NCT00386477|O1|Outcome|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
361226|NCT00386477|E2|Reported Event|Control|No vaginal cleansing or sham wash performed.
361227|NCT00386477|E1|Reported Event|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
361228|NCT00386607|B1|Baseline|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
361229|NCT00386607|P2|Participant Flow|Extension Treatment|"For patients entering into extension, those previously treated with HCTZ (12.5 or 25 mg) in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension.
Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.
The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the msSBP was ≥140 mmHg and/or the msDBP was ≥90 mmHg for 2 consecutive visits."
361230|NCT00386607|P1|Participant Flow|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
361231|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
361232|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
361233|NCT00386607|O1|Outcome|Core and Extension Treatment - Aliskiren/Valsartan/HCTZ|All patients receiving aliskiren / valsartan / HCTZ during either core or extension study.
361234|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
361235|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
361313|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361236|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
361237|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
361238|NCT00386607|O1|Outcome|Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
361239|NCT00386607|E6|Reported Event|Core and Extension: Total|Core and Extension: Total includes all study patients, treated with Aliskiren/Valsartan or Aliskiren//valsartan/HCTZ during core or extension.
361240|NCT00386607|E5|Reported Event|Core and Extension: Aliskiren / Valsartan / HCTZ 25 mg|Core and Extension: Aliskiren/Valsartan/HCTZ 25 mg
361241|NCT00386607|E4|Reported Event|Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg|Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
361242|NCT00386607|E3|Reported Event|Core Period: Aliskiren / Valsartan|Core Period: Aliskiren/Valsartan
361243|NCT00386607|E2|Reported Event|Core Period: Aliskiren 300 mg / Valsartan 320 mg Alone|Core Period: Aliskiren 300 mg /Valsartan 320 mg alone
361244|NCT00386607|E1|Reported Event|Core Period: Aliskiren 150 mg / Valsartan 160 mg Alone|Core Period: Aliskiren 150 mg /Valsartan 160 mg alone
361245|NCT00386776|B1|Baseline|Experimental|The intervention is a computer-based medical interview, which contains 232 primary questions that are asked of all respondents, and over 6000 frames (questions, explanations, suggestions, recommendations, and words of encouragement) that are available for presentation as determined by the patient's responses and the branching logic of the program.
361246|NCT00386776|P1|Participant Flow|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
361247|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
361248|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
361249|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
361250|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
361251|NCT00386776|O1|Outcome|Computer-based Medical History|"The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses Yes, No, Uncertain (Don't Know, Maybe), Don't understand, and I'd rather not answer; 10 have other sets of multiple choices, one response permitted; five have multiple choices with more than one response permitted, and two have numerical responses. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,"
361252|NCT00386776|O1|Outcome|Computer-based Medical History|A computer-based medical history to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like.
361253|NCT00386776|O1|Outcome|Computer-based Medical History|A computer-based medical history to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like.
361254|NCT00386776|E1|Reported Event|Computer-based Medical History|"The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses Yes, No, Uncertain (Don't Know, Maybe), Don't understand, and I'd rather not answer; 10 have other sets of multiple choices, one response permitted; five have multiple choices with more than one response permitted, and two have numerical responses. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,"
361255|NCT00386880|B1|Baseline|Subjects With Episodic Migraine|Subjects with less than 8 distict migraine episodes per month.
361256|NCT00386880|P2|Participant Flow|Subjects With Episodic Migraine Without Allodynia|These are the subjects with episodic migraine without allodynia.
361257|NCT00386880|P1|Participant Flow|Subjects With Episodic Migraine With Allodynia|These are the subjects with episodic migraine with allodynia.
361258|NCT00386880|O2|Outcome|Subjects With Episodic Migraine Without Allodynia|These are subjects with episodic migraine without allodynia
361259|NCT00386880|O1|Outcome|Subjects With Episodic Migraine With Allodynia|These are subjects with episodic migraine with allodynia
361260|NCT00386880|E1|Reported Event|Subjects With Episodic Migraine|
361261|NCT00387010|B1|Baseline|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361262|NCT00387010|P1|Participant Flow|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361263|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361264|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361265|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361266|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361267|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361268|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361269|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
364160|NCT00394472|E2|Reported Event|Placebo|Placebo capsules bid
361270|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361271|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361272|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361273|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361274|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361275|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361276|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361277|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361278|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361314|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361279|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361280|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361281|NCT00387010|E1|Reported Event|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
361282|NCT00387023|B1|Baseline|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
361283|NCT00387023|P1|Participant Flow|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 millicurie (mCi)/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
361284|NCT00387023|O1|Outcome|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
361285|NCT00387023|E1|Reported Event|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
361286|NCT00387036|B1|Baseline|Entire Study Population|
361287|NCT00387036|P2|Participant Flow|Placebo Then Fluticasone Propionate|Following 1 week Placebo run-in period (Period I), patients were randomized to receive placebo 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week fluticasone propionate 250 mcg HFA 2 inhalations twice daily (Period IV).
361288|NCT00387036|P1|Participant Flow|Fluticasone Propionate Then Placebo|Following 1 week Placebo run-in period (Period I), patients were randomized to receive fluticasone propionate 250 mcg Hydrofluoroalkane (HFA) 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week placebo 2 inhalations twice daily (Period IV).
361289|NCT00387036|O2|Outcome|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
361290|NCT00387036|O1|Outcome|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
361291|NCT00387036|O2|Outcome|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
361292|NCT00387036|O1|Outcome|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
361293|NCT00387036|E2|Reported Event|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
361294|NCT00387036|E1|Reported Event|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
361295|NCT00387088|B3|Baseline|Total|Total of all reporting groups
361296|NCT00387088|B2|Baseline|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361297|NCT00387088|B1|Baseline|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361298|NCT00387088|P2|Participant Flow|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361942|NCT00382174|O2|Outcome|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
361299|NCT00387088|P1|Participant Flow|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361300|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361301|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361302|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361303|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361304|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361305|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361306|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361307|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361308|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361309|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361310|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361311|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361312|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361385|NCT00387153|B1|Baseline|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
361315|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361316|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361317|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361318|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361319|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361320|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361321|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361322|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361323|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361324|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361325|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361326|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361327|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361328|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361329|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361330|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361331|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361332|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361333|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361334|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361335|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361336|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361337|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361338|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361339|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361340|NCT00387088|E2|Reported Event|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361341|NCT00387088|E1|Reported Event|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
361342|NCT00387127|B3|Baseline|Total|Total of all reporting groups
361343|NCT00387127|B2|Baseline|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361344|NCT00387127|B1|Baseline|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361386|NCT00387153|P1|Participant Flow|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
361387|NCT00387153|O1|Outcome|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
361424|NCT00387426|P1|Participant Flow|Sunitinib|37.5 mg orally daily for 6-week cycle
361345|NCT00387127|P2|Participant Flow|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361346|NCT00387127|P1|Participant Flow|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361347|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361348|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361349|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361405|NCT00387348|B3|Baseline|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
361406|NCT00387348|B2|Baseline|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
361407|NCT00387348|B1|Baseline|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
361619|NCT00381563|B1|Baseline|Intervention to Placebo|Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.
361350|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361351|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361352|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361353|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361354|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361355|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361356|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361357|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361358|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361359|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361360|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361361|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361362|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361363|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361364|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361365|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361366|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361367|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361368|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361369|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361370|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361371|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361372|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361373|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361374|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361375|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361376|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361377|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361378|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361379|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361380|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361381|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction &lt;2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361382|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361383|NCT00387127|E2|Reported Event|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
361384|NCT00387127|E1|Reported Event|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
361388|NCT00387153|E1|Reported Event|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
361389|NCT00387335|B3|Baseline|Total|Total of all reporting groups
361390|NCT00387335|B2|Baseline|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
361391|NCT00387335|B1|Baseline|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
361392|NCT00387335|P2|Participant Flow|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.ECOG Performance Status 2.
361393|NCT00387335|P1|Participant Flow|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
361394|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
361395|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
361396|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
361397|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
361398|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
361399|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
361400|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
361401|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
361402|NCT00387335|E2|Reported Event|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
361403|NCT00387335|E1|Reported Event|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
361404|NCT00387348|B4|Baseline|Total|Total of all reporting groups
361408|NCT00387348|P3|Participant Flow|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
361409|NCT00387348|P2|Participant Flow|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
361410|NCT00387348|P1|Participant Flow|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks.
361411|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
361412|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
361413|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
361414|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
361415|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
361416|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
361417|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram f10 mg once daily by mouth or the first 4 weeks and placebo once daily by mouth for the second 4 weeks
361418|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
361419|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo oncedaily by mouth for the second 4 weeks
361420|NCT00387348|E3|Reported Event|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
361421|NCT00387348|E2|Reported Event|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
361422|NCT00387348|E1|Reported Event|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
361423|NCT00387426|B1|Baseline|Sunitinib|37.5 mg orally daily for 6-week cycle
361425|NCT00387426|O1|Outcome|Sunitinib|37.5 mg orally daily for 6-week cycle
361426|NCT00387426|E1|Reported Event|Sunitinib|37.5 mg orally daily for 6-week cycle
361427|NCT00387621|B4|Baseline|Total|Total of all reporting groups
361428|NCT00387621|B3|Baseline|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
361429|NCT00387621|B2|Baseline|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
361430|NCT00387621|B1|Baseline|Control Group (Normals)|Healthy volunteers without heart disease
361431|NCT00387621|P2|Participant Flow|Nesiritide First, Then Placebo (Arm B)|In the first intervention period the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.
361432|NCT00387621|P1|Participant Flow|Placebo First, Then Nesiritide (Arm A)|In the first intervention period the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.
361433|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
361434|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
361435|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
361436|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
361437|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
361438|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
361439|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
361440|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
361441|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
361442|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
361443|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
361444|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
361445|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361465|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
364161|NCT00394472|E1|Reported Event|AZD3355|AZD3355 capsules 65 mg bid
361446|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361447|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361448|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361449|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361450|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361451|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361452|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361453|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361513|NCT00387751|B1|Baseline|Bevacizumab and Sorafenib|
361514|NCT00387751|P1|Participant Flow|Bevacizumab and Sorafenib|
361563|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
361454|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361455|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361456|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361457|NCT00387621|O1|Outcome|Control Group|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) and Nesiritide First, then Placebo (Arm B).
361458|NCT00387621|O1|Outcome|Control Group|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
361459|NCT00387621|E2|Reported Event|Nesiritide|The first 10 subjects in each group received a dose of 5 ug/kg and the next 10 subjects received a dose of 10 ug/kg. As this was a cross over study, all participants received placebo and nesiritide.
361460|NCT00387621|E1|Reported Event|Placebo|The pharmacy created a placebo subcutaneous injection volume to match the volume of the nesiritide dose. As this was a cross over study, all participants received placebo and nesiritide.
361461|NCT00387647|B1|Baseline|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
361462|NCT00387647|P1|Participant Flow|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
361463|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
361464|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
361620|NCT00381563|P2|Participant Flow|Placebo to Intervention|Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
361466|NCT00387647|E1|Reported Event|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
361467|NCT00387660|B3|Baseline|Total|Total of all reporting groups
361468|NCT00387660|B2|Baseline|Arm B|Relapsed small cell lung cancer with previous chemotherapy
361469|NCT00387660|B1|Baseline|Arm A|Metastatic small cell lung cancer with no previous chemotherapy
361470|NCT00387660|P2|Participant Flow|Arm B - Relapsed SCLC (Previous Chemo)|Relapsed small cell lung cancer with previous chemotherapy
361471|NCT00387660|P1|Participant Flow|Arm A - Metastatic SCLC (no Previous Chemo)|Extensive small cell lung cancer with no previous chemotherapy
361472|NCT00387660|O2|Outcome|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
361473|NCT00387660|O1|Outcome|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
361474|NCT00387660|O2|Outcome|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
361475|NCT00387660|O1|Outcome|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
361476|NCT00387660|O2|Outcome|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
361477|NCT00387660|O1|Outcome|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
361478|NCT00387660|E2|Reported Event|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
361479|NCT00387660|E1|Reported Event|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
361480|NCT00387673|B1|Baseline|Effect of Prolonged Electrical Stimulation on Neural Plastici|
361481|NCT00387673|P3|Participant Flow|Arm 3|"a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training
Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
361559|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
361560|NCT00387881|O1|Outcome|Placebo|
361561|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
361562|NCT00387881|O1|Outcome|Placebo|
361482|NCT00387673|P2|Participant Flow|Arm 2|"a 6-week period of 2 hours somatosensory stimulation of the hand, without training
Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
361483|NCT00387673|P1|Participant Flow|Arm 1|"6 weeks of upper extremity training for 3 sessions/week, as follows: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session);
Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
361484|NCT00387673|O3|Outcome|Arm 3|"a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training
Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
361485|NCT00387673|O2|Outcome|Arm 2|"a 6-week period of 2 hours somatosensory stimulation of the hand, without training
Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
361582|NCT00387959|O1|Outcome|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
361684|NCT00381628|B5|Baseline|Total|Total of all reporting groups
361486|NCT00387673|O1|Outcome|Arm 1|"6 weeks of upper extremity training for 3 sessions/week, as follows: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session);
Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
361487|NCT00387673|E1|Reported Event|Project Closed|
361488|NCT00387725|B5|Baseline|Total|Total of all reporting groups
361489|NCT00387725|B4|Baseline|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
361490|NCT00387725|B3|Baseline|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
361491|NCT00387725|B2|Baseline|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
361492|NCT00387725|B1|Baseline|Twinrix|Given on a 0, 1-, 6- month schedule
361493|NCT00387725|P4|Participant Flow|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
361494|NCT00387725|P3|Participant Flow|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
361495|NCT00387725|P2|Participant Flow|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
361496|NCT00387725|P1|Participant Flow|Twinrix|Given on a 0, 1-, 6- month schedule
361497|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
361498|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
361499|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
361500|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
361501|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
361502|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
361503|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
361504|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
361505|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
361506|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
361507|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
361508|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
361509|NCT00387725|E4|Reported Event|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
361510|NCT00387725|E3|Reported Event|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
361511|NCT00387725|E2|Reported Event|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
361512|NCT00387725|E1|Reported Event|Twinrix|Given on a 0, 1-, 6- month schedule
361564|NCT00387881|O1|Outcome|Placebo|
361515|NCT00387751|O1|Outcome|Bevacizumab and Sorafenib|"Bevacizumab was administered as a 5 mg/kg intravenous dose every 2 weeks. The dose was based on the patient's actual body weight; the dose recalculated if there was a weight change of >10% from baseline.
Sorafenib was administered as a 200 mg oral dose twice daily, for 5 days every 7 days. Courses will be defined as 28-day treatment periods and will be repeated without interruption until development of progressive disease or development of serious drug related toxicities."
361516|NCT00387751|E1|Reported Event|Bevacizumab and Sorafenib|
361517|NCT00387764|B1|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361518|NCT00387764|P1|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361519|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361520|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361521|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361522|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361523|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361524|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361525|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361526|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361527|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361528|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361529|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361530|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361531|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361532|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361533|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361534|NCT00387764|E1|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
361535|NCT00387790|B1|Baseline|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
364162|NCT00397462|B4|Baseline|Total|Total of all reporting groups
361536|NCT00387790|P1|Participant Flow|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
361537|NCT00387790|O1|Outcome|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
361538|NCT00387790|E1|Reported Event|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
361539|NCT00387829|B3|Baseline|Total|Total of all reporting groups
361540|NCT00387829|B2|Baseline|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
361541|NCT00387829|B1|Baseline|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
361542|NCT00387829|P2|Participant Flow|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
361543|NCT00387829|P1|Participant Flow|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
361544|NCT00387829|O2|Outcome|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
361545|NCT00387829|O1|Outcome|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
361546|NCT00387829|O2|Outcome|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
361547|NCT00387829|O1|Outcome|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
361548|NCT00387829|E2|Reported Event|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
361549|NCT00387829|E1|Reported Event|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
361550|NCT00387881|B3|Baseline|Total|Total of all reporting groups
361551|NCT00387881|B2|Baseline|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet. Baseline Characteristics used the Safety Population. Not the Randomised Population
361552|NCT00387881|B1|Baseline|Placebo|Baseline Characteristics used the Safety Population. Not the Randomised Population
361553|NCT00387881|P2|Participant Flow|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
361554|NCT00387881|P1|Participant Flow|Placebo|
361555|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
361556|NCT00387881|O1|Outcome|Placebo|
361557|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
361558|NCT00387881|O1|Outcome|Placebo|
361565|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
361566|NCT00387881|O1|Outcome|Placebo|
361567|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
361568|NCT00387881|O1|Outcome|Placebo|
361569|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
361570|NCT00387881|O1|Outcome|Placebo|
361571|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
361572|NCT00387881|O1|Outcome|Placebo|
361573|NCT00387881|E2|Reported Event|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
361574|NCT00387881|E1|Reported Event|Placebo|
361575|NCT00387894|B1|Baseline|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
361576|NCT00387894|P1|Participant Flow|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|Tarceva self-administered in an open-label, unblinded manner to all patients enrolled. During the treatment period, patients who are not receiving enzyme-inducing antiepileptic drugs (EIAED) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days from 150 to 200 mg/day or from 600 to 650 mg/day assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.
361577|NCT00387894|O1|Outcome|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
361578|NCT00387894|O1|Outcome|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
361579|NCT00387894|E1|Reported Event|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
361580|NCT00387959|B1|Baseline|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
361581|NCT00387959|P1|Participant Flow|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
361838|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
361583|NCT00387959|E1|Reported Event|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
361584|NCT00388037|B1|Baseline|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO
laboratory biomarker analysis: Correlative studies"
361585|NCT00388037|P1|Participant Flow|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO
laboratory biomarker analysis: Correlative studies"
361586|NCT00388037|O1|Outcome|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO
laboratory biomarker analysis: Correlative studies"
361587|NCT00388037|E1|Reported Event|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO
laboratory biomarker analysis: Correlative studies"
361588|NCT00381485|B4|Baseline|Total|Total of all reporting groups
361589|NCT00381485|B3|Baseline|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
361590|NCT00381485|B2|Baseline|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361591|NCT00381485|B1|Baseline|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361592|NCT00381485|P4|Participant Flow|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
361593|NCT00381485|P3|Participant Flow|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361594|NCT00381485|P2|Participant Flow|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361595|NCT00381485|P1|Participant Flow|Open-Label MF MDI 400 mcg BID|Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
361596|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
361597|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361598|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361599|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
361600|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361601|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361602|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
361603|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361604|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361605|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
361606|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361607|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361608|NCT00381485|E4|Reported Event|Open-Label MF MDI 400 mcg BID|Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
361609|NCT00381485|E3|Reported Event|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
361610|NCT00381485|E2|Reported Event|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361611|NCT00381485|E1|Reported Event|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
361612|NCT00381550|B1|Baseline|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
361613|NCT00381550|P1|Participant Flow|Triapine and Fludarabine Phosphate|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
361614|NCT00381550|O1|Outcome|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
361615|NCT00381550|O1|Outcome|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
361616|NCT00381550|E1|Reported Event|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
361617|NCT00381563|B3|Baseline|Total|Total of all reporting groups
361618|NCT00381563|B2|Baseline|Placebo to Intervention|Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
361839|NCT00381849|E2|Reported Event|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
361621|NCT00381563|P1|Participant Flow|Intervention to Placebo|Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.
361622|NCT00381563|O1|Outcome|Intervention Brace|"All participants who completed the trial (n=67) are re-grouped into the intervention brace group."
361623|NCT00381563|O1|Outcome|Intervention Brace|"All participants who completed the trial (n=67) are re-grouped into the intervention brace group."
361624|NCT00381563|O1|Outcome|Intervention Brace|"All participants who completed the trial (n=67) are re-grouped into the intervention brace group."
361625|NCT00381563|E2|Reported Event|Placebo to Intervention|Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
361626|NCT00381563|E1|Reported Event|Intervention to Placebo|Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.
361627|NCT00381615|B5|Baseline|Total|Total of all reporting groups
361628|NCT00381615|B4|Baseline|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
361629|NCT00381615|B3|Baseline|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
361630|NCT00381615|B2|Baseline|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361631|NCT00381615|B1|Baseline|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361632|NCT00381615|P4|Participant Flow|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
361633|NCT00381615|P3|Participant Flow|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
361634|NCT00381615|P2|Participant Flow|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361635|NCT00381615|P1|Participant Flow|rMenB|"Infants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without Outer Membrane Vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of diphtheria-tetanus-acellular pertussis vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months)."
361636|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361637|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361638|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361639|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361640|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
361641|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
361642|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361643|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361840|NCT00381849|E1|Reported Event|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
361943|NCT00382174|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
364163|NCT00397462|B3|Baseline|Control|No use of the intervention
361644|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361645|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361646|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
361647|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
361648|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361649|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361650|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
361651|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
361652|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361653|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361654|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
362036|NCT00388973|B3|Baseline|Total|Total of all reporting groups
361655|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
361656|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361657|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361658|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
361659|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
361660|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361661|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361662|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
361663|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
361944|NCT00382174|E3|Reported Event|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
361664|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361665|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361666|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
361667|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
361668|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361669|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361670|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
361671|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
361672|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361673|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361674|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361709|NCT00381680|O2|Outcome|Regimen B|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
361710|NCT00381680|O1|Outcome|Regimen A|Standard VCR dosing (1.5 mg/m^2, max 2mg)
361675|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361676|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
361677|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
361678|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361679|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361680|NCT00381615|E4|Reported Event|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
361681|NCT00381615|E3|Reported Event|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
361682|NCT00381615|E2|Reported Event|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361683|NCT00381615|E1|Reported Event|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
361685|NCT00381628|B4|Baseline|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361686|NCT00381628|B3|Baseline|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361687|NCT00381628|B2|Baseline|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361688|NCT00381628|B1|Baseline|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361689|NCT00381628|P4|Participant Flow|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361690|NCT00381628|P3|Participant Flow|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361711|NCT00381680|O2|Outcome|Regimen B|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
361712|NCT00381680|O1|Outcome|Regimen A|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
361691|NCT00381628|P2|Participant Flow|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361692|NCT00381628|P1|Participant Flow|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361693|NCT00381628|O4|Outcome|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361694|NCT00381628|O3|Outcome|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361695|NCT00381628|O2|Outcome|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
364679|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
361696|NCT00381628|O1|Outcome|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361697|NCT00381628|E4|Reported Event|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361698|NCT00381628|E3|Reported Event|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361699|NCT00381628|E2|Reported Event|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361700|NCT00381628|E1|Reported Event|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.
epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
361701|NCT00381680|B3|Baseline|Total|Total of all reporting groups
361702|NCT00381680|B2|Baseline|Arm B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
361703|NCT00381680|B1|Baseline|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
361704|NCT00381680|P2|Participant Flow|Regimen B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
361705|NCT00381680|P1|Participant Flow|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
361706|NCT00381680|O1|Outcome|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
361707|NCT00381680|O2|Outcome|Regimen B|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
361708|NCT00381680|O1|Outcome|Regimen A|Standard VCR dosing (1.5 mg/m^2, max 2mg)
361713|NCT00381680|O2|Outcome|Arm B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
361714|NCT00381680|O1|Outcome|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
361715|NCT00381680|O1|Outcome|All Patients|This analysis looks at all eligible patients with CC or CT genotypes as well as all eligible patients with the high-risk CEP72 genotype (TT at rs924607).
361716|NCT00381680|O1|Outcome|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
361717|NCT00381680|E2|Reported Event|Arm B: Randomized High Dose Vincristine Regimen|"See detailed description. Closed to accrual as of 09/2010).
vincristine sulfate: Given IV
prednisone: Given PO
doxorubicin hydrochloride: Given IV
pegaspargase: Given IM
cytarabine: Given IT or IV
methotrexate: Given IT or IV
dexamethasone: Given PO
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV or PO
filgrastim: Given IV or SC
asparaginase: Given IM
mercaptopurine: Given PO"
361718|NCT00381680|E1|Reported Event|Regimen A: Standard Vincristine Dosing|"See detailed description.
vincristine sulfate: Given IV
prednisone: Given PO
doxorubicin hydrochloride: Given IV
pegaspargase: Given IM
cytarabine: Given IT or IV
methotrexate: Given IT or IV
dexamethasone: Given PO
etoposide: Given IV
cyclophosphamide: Given IV
leucovorin calcium: Given IV or PO
filgrastim: Given IV or SC
asparaginase: Given IM
mercaptopurine: Given PO"
361719|NCT00381693|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
361720|NCT00381693|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
361721|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
361722|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
361723|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
361724|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
361725|NCT00381693|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
361726|NCT00381706|B7|Baseline|Total|Total of all reporting groups
361727|NCT00381706|B6|Baseline|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
361841|NCT00381862|B1|Baseline|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
Palonosetron: 0.25 mg IV push on day 1 only"
361728|NCT00381706|B5|Baseline|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361729|NCT00381706|B4|Baseline|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361730|NCT00381706|B3|Baseline|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
361731|NCT00381706|B2|Baseline|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361732|NCT00381706|B1|Baseline|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361733|NCT00381706|P3|Participant Flow|ARM C (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
361734|NCT00381706|P2|Participant Flow|Arm B (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361816|NCT00381810|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
362037|NCT00388973|B2|Baseline|Placebo|Placebo
361735|NCT00381706|P1|Participant Flow|Arm A (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361736|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
361737|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361738|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361739|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
361740|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361741|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361742|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
361743|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361744|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361745|NCT00381706|O3|Outcome|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
361746|NCT00381706|O2|Outcome|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361817|NCT00381810|P1|Participant Flow|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
361837|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
361747|NCT00381706|O1|Outcome|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361748|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
361749|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361750|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361842|NCT00381862|P1|Participant Flow|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
Palonosetron: 0.25 mg IV push on day 1 only"
361843|NCT00381862|O1|Outcome|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
Palonosetron: 0.25 mg IV push on day 1 only"
361844|NCT00381862|E1|Reported Event|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
Palonosetron: 0.25 mg IV push on day 1 only"
361751|NCT00381706|E6|Reported Event|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
361752|NCT00381706|E5|Reported Event|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361753|NCT00381706|E4|Reported Event|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361754|NCT00381706|E3|Reported Event|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
361755|NCT00381706|E2|Reported Event|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361756|NCT00381706|E1|Reported Event|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
361757|NCT00381797|B6|Baseline|Total|Total of all reporting groups
361758|NCT00381797|B5|Baseline|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361818|NCT00381810|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
361819|NCT00381810|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
361759|NCT00381797|B4|Baseline|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361760|NCT00381797|B3|Baseline|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361845|NCT00381888|B1|Baseline|Patients Enrolled and Consented|This number includes all patients that were consented and enrolled in the study and received at least one dose of study drug.
361846|NCT00381888|P1|Participant Flow|Patients Enrolled and Consented|This number includes all patients consented and enrolled in this study.
361847|NCT00381888|O1|Outcome|Fondaparinux Patients Who Completed Study|This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
361761|NCT00381797|B2|Baseline|Brain Stem Tumors|Recurrent,progressive or refractory intrinsic brain stem tumors (Stratum B): The only patients with Recurrent,progressive or refractory intrinsic brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361762|NCT00381797|B1|Baseline|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361763|NCT00381797|P5|Participant Flow|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361764|NCT00381797|P4|Participant Flow|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361765|NCT00381797|P3|Participant Flow|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361766|NCT00381797|P2|Participant Flow|Brain Stem Tumors|Recurrent,progressive or refractory intrinsic brain stem tumors (Stratum B): The only patients with Recurrent,progressive or refractory intrinsic brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361820|NCT00381849|B3|Baseline|Total|Total of all reporting groups
361821|NCT00381849|B2|Baseline|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
361822|NCT00381849|B1|Baseline|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
363421|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
361767|NCT00381797|P1|Participant Flow|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361848|NCT00381888|O1|Outcome|Fondaparinux Patients Who Completed Study|This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
361849|NCT00381888|E1|Reported Event|All Patients Who Received at Least One Dose of Fondaparinux|This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux.
361945|NCT00382174|E2|Reported Event|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
361946|NCT00382174|E1|Reported Event|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
362014|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
361768|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361769|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361770|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361771|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361772|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361773|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361774|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361823|NCT00381849|P2|Participant Flow|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
361824|NCT00381849|P1|Participant Flow|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
361775|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
364887|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
361776|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent, progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361777|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361778|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361779|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361780|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361781|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361782|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361825|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
361826|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
363422|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
361850|NCT00381940|B1|Baseline|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.
ifosfamide: Given IV
bortezomib: Given IV
vinorelbine ditartrate: Given IV
filgrastim: Given IV or SC"
361783|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors (Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361784|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361785|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent,progressive or refractory instrinsic brain stem tumors(Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361786|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361787|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361788|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361789|NCT00381797|O4|Outcome|Low Grade Glioma|Recurrent low grade glioma(Stratum E):The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361790|NCT00381797|O3|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361827|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
361828|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
361829|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
361791|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361792|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361793|NCT00381797|O3|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361794|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory Brain Stem Tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361795|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361796|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with Recurrent, progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361797|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with Recurrent or progressive Medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361798|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361830|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
361831|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
361832|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
361799|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361800|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E): The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361801|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361802|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with Recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361803|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361804|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361805|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361806|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361833|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
361834|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
361835|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
363423|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
361807|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361808|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361809|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A): The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361810|NCT00381797|O1|Outcome|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361811|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361812|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361813|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors (Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361814|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
361815|NCT00381797|E1|Reported Event|PBTC-022|Children with recurrent,progressive,or refractory malignant gliomas, diffuse/intrinsic brain stem gliomas, medulloblastomas and low grade gliomas
361836|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
363424|NCT00392678|O1|Outcome|Placebo|Placebo
361851|NCT00381940|P1|Participant Flow|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.
ifosfamide: Given IV
bortezomib: Given IV
vinorelbine ditartrate: Given IV
filgrastim: Given IV or SC"
361852|NCT00381940|O1|Outcome|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.
ifosfamide: Given IV
bortezomib: Given IV
vinorelbine ditartrate: Given IV
filgrastim: Given IV or SC"
361853|NCT00381940|E1|Reported Event|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.
ifosfamide: Given IV
bortezomib: Given IV
vinorelbine ditartrate: Given IV
filgrastim: Given IV or SC"
361854|NCT00382018|B5|Baseline|Total|Total of all reporting groups
361855|NCT00382018|B4|Baseline|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
361856|NCT00382018|B3|Baseline|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
361857|NCT00382018|B2|Baseline|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
361858|NCT00382018|B1|Baseline|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
361859|NCT00382018|P4|Participant Flow|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
361922|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361860|NCT00382018|P3|Participant Flow|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
361861|NCT00382018|P2|Participant Flow|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
361862|NCT00382018|P1|Participant Flow|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
361863|NCT00382018|O3|Outcome|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
361864|NCT00382018|O2|Outcome|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
361865|NCT00382018|O1|Outcome|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|
361866|NCT00382018|O3|Outcome|Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
361867|NCT00382018|O2|Outcome|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
361868|NCT00382018|O1|Outcome|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
361869|NCT00382018|O3|Outcome|Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
361870|NCT00382018|O2|Outcome|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
361933|NCT00382174|B2|Baseline|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
361934|NCT00382174|B1|Baseline|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
361871|NCT00382018|O1|Outcome|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
361872|NCT00382018|O2|Outcome|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
361873|NCT00382018|O1|Outcome|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
361874|NCT00382018|O2|Outcome|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
361875|NCT00382018|O1|Outcome|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
361876|NCT00382018|E3|Reported Event|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
361877|NCT00382018|E2|Reported Event|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
361878|NCT00382018|E1|Reported Event|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|
361879|NCT00382031|B3|Baseline|Total|Total of all reporting groups
361880|NCT00382031|B2|Baseline|Control|Best Supportive Care
361881|NCT00382031|B1|Baseline|Zalutumumab|Zalutumumab in combination with Best Supportive Care
361882|NCT00382031|P2|Participant Flow|Control|Best Supportive Care
361883|NCT00382031|P1|Participant Flow|Zalutumumab|Zalutumumab in combination with Best Supportive Care. Patients received weekly infusions of zalutumumab. After a loading dose of 8 mg/kg the dose was reduced to 4 mg/kg and individual dose titration based on skin rash evaluation was performed.
361884|NCT00382031|O2|Outcome|Control|Best Supportive Care
361885|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
361886|NCT00382031|O2|Outcome|Control|Best Supportive Care
361887|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
361888|NCT00382031|O2|Outcome|Control|Best Supportive Care
361889|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
361890|NCT00382031|O2|Outcome|Control|Best Supportive Care
361891|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
361892|NCT00382031|E2|Reported Event|Control|Best Supportive Care
361893|NCT00382031|E1|Reported Event|Zalutumumab|Zalutumumab in combination with Best Supportive Care
361894|NCT00382109|B3|Baseline|Total|Total of all reporting groups
361895|NCT00382109|B2|Baseline|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
362038|NCT00388973|B1|Baseline|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
361896|NCT00382109|B1|Baseline|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
361897|NCT00382109|P2|Participant Flow|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
361935|NCT00382174|P3|Participant Flow|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
361936|NCT00382174|P2|Participant Flow|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
361937|NCT00382174|P1|Participant Flow|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
361938|NCT00382174|O3|Outcome|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
361939|NCT00382174|O2|Outcome|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
361940|NCT00382174|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
361941|NCT00382174|O3|Outcome|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
361898|NCT00382109|P1|Participant Flow|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
361899|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
361900|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
361901|NCT00382109|O1|Outcome|All Patients|Relative contribution of ALL blasts to the donor immune response as a cause of relapse pre transplantation (MRD)
361902|NCT00382109|O1|Outcome|All Patients|Relative contribution of ALL blasts to the donor immune response as a cause of relapse post transplantation (correlating development of aGVHD with relapse).
361903|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
361904|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
361905|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
361906|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
361907|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
361908|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
361909|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
361910|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
361911|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
361912|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
361913|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
361914|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
361915|NCT00382109|E2|Reported Event|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
361916|NCT00382109|E1|Reported Event|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
361917|NCT00382148|B3|Baseline|Total|Total of all reporting groups
361918|NCT00382148|B2|Baseline|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361919|NCT00382148|B1|Baseline|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361920|NCT00382148|P2|Participant Flow|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361921|NCT00382148|P1|Participant Flow|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
362039|NCT00388973|P2|Participant Flow|Placebo|Placebo
361923|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361924|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361925|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361926|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361927|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361928|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361929|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361930|NCT00382148|E2|Reported Event|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361931|NCT00382148|E1|Reported Event|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
361932|NCT00382174|B3|Baseline|Total|Total of all reporting groups
361947|NCT00388154|B1|Baseline|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
361948|NCT00388154|P1|Participant Flow|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
361949|NCT00388154|O1|Outcome|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
361950|NCT00388154|O1|Outcome|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
361951|NCT00388154|E1|Reported Event|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
361952|NCT00388349|B1|Baseline|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
361953|NCT00388349|P2|Participant Flow|1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
361954|NCT00388349|P1|Participant Flow|1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
361955|NCT00388349|O1|Outcome|1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine 1250 mg/m2 administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
361956|NCT00388349|O1|Outcome|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine (1250 or 1500 mg/m2) as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
361957|NCT00388349|O1|Outcome|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine (1250 or 1500 mg/m2) as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
361958|NCT00388349|O1|Outcome|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine (1250 or 1500 mg/m2) administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
361959|NCT00388349|O2|Outcome|1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
361989|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361960|NCT00388349|O1|Outcome|1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
361961|NCT00388349|E1|Reported Event|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
361962|NCT00388362|B1|Baseline|Sirolimus|Administration of Sirolimus and Prednisone
361963|NCT00388362|P1|Participant Flow|Sirolimus Therapy|Administration of Sirolimus and Prednisone
361964|NCT00388362|O1|Outcome|Sirolimus Therapy|Administration of Sirolimus and Prednisone
361965|NCT00388362|O1|Outcome|Sirolimus Therapy|Administration of Sirolimus and Prednisone
361966|NCT00388362|E1|Reported Event|Sirolimus Therapy|Administration of Sirolimus and Prednisone
361967|NCT00388505|B3|Baseline|Total|Total of all reporting groups
361968|NCT00388505|B2|Baseline|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361969|NCT00388505|B1|Baseline|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361970|NCT00388505|P2|Participant Flow|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361971|NCT00388505|P1|Participant Flow|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361972|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361973|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361974|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361975|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361976|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361977|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361978|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361979|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361980|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361981|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361982|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361983|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361984|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361985|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361986|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361987|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361988|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361990|NCT00388505|E2|Reported Event|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361991|NCT00388505|E1|Reported Event|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
361992|NCT00388583|B3|Baseline|Total|Total of all reporting groups
361993|NCT00388583|B2|Baseline|Fluzone IM Vaccine Group|Participants received a dose (0.5 mL) of Fluzone intramuscular vaccine on Day 0.
361994|NCT00388583|B1|Baseline|Fluzone ID Vaccine Group|Participants received a dose (0.1 mL) of Fluzone intradermal vaccine on Day 0.
361995|NCT00388583|P2|Participant Flow|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
361996|NCT00388583|P1|Participant Flow|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
361997|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
361998|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
361999|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
362000|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
362001|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
362002|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
362003|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
362004|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
362005|NCT00388583|E2|Reported Event|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
362006|NCT00388583|E1|Reported Event|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
362007|NCT00388726|B3|Baseline|Total|Total of all reporting groups
362008|NCT00388726|B2|Baseline|Treatment of Physician's Choice|Treatment of Physician's Choice
362009|NCT00388726|B1|Baseline|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
362010|NCT00388726|P2|Participant Flow|Treatment of Physician's Choice|Treatment of Physician's Choice
362011|NCT00388726|P1|Participant Flow|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
362012|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
362013|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
362015|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
362016|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
362017|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
362018|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
362019|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
362020|NCT00388726|E2|Reported Event|Treatment of Physician's Choice|Treatment of Physician's Choice
362021|NCT00388726|E1|Reported Event|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
362022|NCT00388804|B3|Baseline|Total|Total of all reporting groups
362023|NCT00388804|B2|Baseline|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
362024|NCT00388804|B1|Baseline|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
362025|NCT00388804|P2|Participant Flow|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
362026|NCT00388804|P1|Participant Flow|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
362027|NCT00388804|O2|Outcome|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
362028|NCT00388804|O1|Outcome|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
362029|NCT00388804|E2|Reported Event|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
362030|NCT00388804|E1|Reported Event|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
362031|NCT00388947|B1|Baseline|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
362032|NCT00388947|P1|Participant Flow|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
362033|NCT00388947|O1|Outcome|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
362034|NCT00388947|O1|Outcome|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
362035|NCT00388947|E1|Reported Event|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
362040|NCT00388973|P1|Participant Flow|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
362041|NCT00388973|O2|Outcome|Placebo|Placebo
362042|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
362043|NCT00388973|O2|Outcome|Placebo|Placebo
362044|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
362045|NCT00388973|O2|Outcome|Placebo|Placebo
362046|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
362047|NCT00388973|O2|Outcome|Placebo|Placebo
362048|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
362049|NCT00388973|O2|Outcome|Placebo|Placebo
362050|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
362051|NCT00388973|O2|Outcome|Placebo|Placebo
362052|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
362053|NCT00388973|O2|Outcome|Placebo|Placebo
362054|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
362055|NCT00388973|O2|Outcome|Placebo|Placebo
362056|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
362057|NCT00388973|E2|Reported Event|Placebo|Placebo
362058|NCT00388973|E1|Reported Event|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
362059|NCT00389064|B3|Baseline|Total|Total of all reporting groups
362060|NCT00389064|B2|Baseline|Placebo|
362061|NCT00389064|B1|Baseline|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362062|NCT00389064|P2|Participant Flow|Placebo|
362063|NCT00389064|P1|Participant Flow|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362064|NCT00389064|O2|Outcome|Placebo|
362065|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362066|NCT00389064|O2|Outcome|Placebo|
362067|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362068|NCT00389064|O2|Outcome|Placebo|
362069|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362070|NCT00389064|O2|Outcome|Placebo|
362071|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362072|NCT00389064|O2|Outcome|Placebo|
362073|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362074|NCT00389064|O2|Outcome|Placebo|
362075|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362076|NCT00389064|O2|Outcome|Placebo|
362077|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362078|NCT00389064|O2|Outcome|Placebo|
362079|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362080|NCT00389064|O2|Outcome|Placebo|
364888|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
362081|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362082|NCT00389064|O2|Outcome|Placebo|
362083|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362084|NCT00389064|O2|Outcome|Placebo|
362085|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362086|NCT00389064|E2|Reported Event|Placebo|
362087|NCT00389064|E1|Reported Event|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
362088|NCT00389168|B3|Baseline|Total|Total of all reporting groups
362089|NCT00389168|B2|Baseline|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362090|NCT00389168|B1|Baseline|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362091|NCT00389168|P2|Participant Flow|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg
362092|NCT00389168|P1|Participant Flow|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg
362093|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362094|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362095|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362096|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362097|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362098|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362099|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362100|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362101|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362102|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
363425|NCT00392678|O4|Outcome|Placebo|Placebo
362103|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362104|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362105|NCT00389168|E2|Reported Event|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362106|NCT00389168|E1|Reported Event|Irbesratan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
362107|NCT00389207|B4|Baseline|Total|Total of all reporting groups
362108|NCT00389207|B3|Baseline|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362109|NCT00389207|B2|Baseline|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362110|NCT00389207|B1|Baseline|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362111|NCT00389207|P3|Participant Flow|Atazanvir/Ritonavir|Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada®
362112|NCT00389207|P2|Participant Flow|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362113|NCT00389207|P1|Participant Flow|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362114|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362115|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362116|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
362117|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362118|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362119|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
362120|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362121|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362122|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
362123|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362124|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362125|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
362126|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362127|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362181|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362128|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
362129|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362130|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362131|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
362132|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362133|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362134|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
362135|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362136|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362137|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
362138|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362139|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362140|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
362141|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362142|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362143|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362144|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362145|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362146|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362147|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362148|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362149|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362150|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362151|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362152|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362153|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362154|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362155|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362357|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362156|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362157|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362158|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362159|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362160|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362161|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362162|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362163|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362164|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362165|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362166|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362167|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362168|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362169|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362170|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362171|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362172|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362173|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362174|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362175|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362176|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362177|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362178|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362179|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362180|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362182|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362183|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362184|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362185|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362186|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362187|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362188|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362189|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362190|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362191|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362192|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362193|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362194|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362195|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362196|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362197|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362198|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362199|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362200|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362201|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362202|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362203|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362204|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362205|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362206|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362207|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362208|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
362209|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
363426|NCT00392678|O3|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
362210|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
362211|NCT00389207|E3|Reported Event|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
362212|NCT00389207|E2|Reported Event|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
362213|NCT00389207|E1|Reported Event|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
362214|NCT00389324|B1|Baseline|Safety Population|The safety population included all subjects who received any amount of study medication (IGIV-C) via intravenous (IV) and/or subcutaneous (SC) routes of administration. As such, the safety population included all study participants combined (who received any dose), whether they entered the study in the Run-In or Intravenous Phase.
362215|NCT00389324|P1|Participant Flow|IGIV-C|"21 subjects were required to enter a Run-In Phase (3 to 4 months) and received IGIV-C between 200 and 600 mg/kg by intravenous infusion every 3 or 4 weeks. 18 subjects completed the Run-In Phase and entered the Intravenous Phase.
A total of 32 subjects entered the IV Phase: 14 subjects who had received IV IGIV-C prior to screening directly entered the IV Phase and 18 subjects who had completed the Run-in Phase continued in the study to enter the IV Phase. Subjects in the IV Phase received two IV infusions at the same dose (200-600 mg/kg) and frequency (every 3 or 4 weeks) as their regular dose at screening or during the Run-In Phase. All 32 subjects completed the IV Phase and entered the SC Phase.
A total of 32 subjects who completed the IV Phase entered the SC Phase. Subjects in the SC Phase received IGIV-C via weekly SC administration for 24 weeks total at a dose that was calculated using a conversion factor and their established IV dose. 25 subjects completed the SC Phase."
362216|NCT00389324|O2|Outcome|Gamunex Subcutaneous (SC) Administration|Subjects who received Gamunex via SC administration.
362217|NCT00389324|O1|Outcome|Gamunex Intravenous (IV) Administration|Subjects who received Gamunex via IV administration.
362218|NCT00389324|E3|Reported Event|Subcutaneous Phase|All subjects who participated in the Subcutaneous Phase.
362219|NCT00389324|E2|Reported Event|Intravenous Phase|All subjects who participated in the Intravenous Phase.
362220|NCT00389324|E1|Reported Event|Run-In Phase|All subjects who participated in the Run-In Phase.
362221|NCT00389441|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
362222|NCT00389441|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
362223|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
362224|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
362225|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
362226|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
362227|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
362228|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
362229|NCT00389441|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
362230|NCT00389467|B5|Baseline|Total|Total of all reporting groups
362231|NCT00389467|B4|Baseline|Standard Care, Nonpenumbral|Treatment assignment = standard medical care, imaging pattern = nonpenumbral
362232|NCT00389467|B3|Baseline|Embolectomy, Nonpenumbral|Treatment assignment = embolectomy, imaging pattern = nonpenumbral
362233|NCT00389467|B2|Baseline|Standard Care, Penumbral|Treatment assignment = standard medical care, imaging pattern = penumbral
362234|NCT00389467|B1|Baseline|Embolectomy, Penumbral|Treatment assignment = embolectomy, imaging pattern = penumbral
362235|NCT00389467|P4|Participant Flow|Standard Care, Nonpenumbral|"Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
362236|NCT00389467|P3|Participant Flow|Embolectomy, Nonpenumbral|"Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
362358|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362237|NCT00389467|P2|Participant Flow|Standard Care, Penumbral|"Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
362238|NCT00389467|P1|Participant Flow|Embolectomy, Penumbral|"Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
362239|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
362240|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
362241|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
362242|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
362243|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
362244|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
362321|NCT00389532|O2|Outcome|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
362245|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
362246|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
362247|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
362248|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
362249|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
362250|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
362251|NCT00389467|E5|Reported Event|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
362252|NCT00389467|E4|Reported Event|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
362253|NCT00389467|E3|Reported Event|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
362359|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
363427|NCT00392678|O2|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
362254|NCT00389467|E2|Reported Event|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
362255|NCT00389467|E1|Reported Event|Total Cohort|
362256|NCT00389493|B4|Baseline|Total|Total of all reporting groups
362257|NCT00389493|B3|Baseline|Treatment With Pill Placebo|"Participants will receive treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone."
362258|NCT00389493|B2|Baseline|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
362259|NCT00389493|B1|Baseline|Treatment With Risperidone|"Participants will receive treatment with risperidone
Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
362260|NCT00389493|P3|Participant Flow|Treatment With Pill Placebo|"Participants will receive treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone."
362261|NCT00389493|P2|Participant Flow|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
362262|NCT00389493|P1|Participant Flow|Treatment With Risperidone|"Participants will receive treatment with risperidone
Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
362263|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants will receive treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone."
362264|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
362265|NCT00389493|O1|Outcome|Treatment With Risperidone|"Participants will receive treatment with risperidone
Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
362266|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants will receive treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone."
362322|NCT00389532|O1|Outcome|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
364889|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
362267|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
362268|NCT00389493|O1|Outcome|Treatment With Risperidone|"Participants will receive treatment with risperidone
Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
362269|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
Mean Y-BOCS score measured at week 8"
362270|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
Mean Y-BOCS score measured at week 8"
362271|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
362272|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
Mean Y-BOCS score measured at week 8"
362273|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
Mean Y-BOCS score measured at week 8"
362274|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
362275|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
Mean Y-BOCS score measured at week 8"
362276|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
Mean Y-BOCS score measured at week 8"
362277|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
362278|NCT00389493|E3|Reported Event|Treatment With Pill Placebo|"Participants received treatment with the placebo
Placebo : Placebo capsules will be identical in appearance to those of risperidone.
Mean Y-BOCS score measured at week 8"
362279|NCT00389493|E2|Reported Event|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy
Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
Mean Y-BOCS score measured at week 8"
362280|NCT00389493|E1|Reported Event|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
362281|NCT00389519|B5|Baseline|Total|Total of all reporting groups
362282|NCT00389519|B4|Baseline|Ramipril High Dose|
362283|NCT00389519|B3|Baseline|Ramipril Mid Dose|
362284|NCT00389519|B2|Baseline|Ramipril Low Dose|
362285|NCT00389519|B1|Baseline|Placebo|
362286|NCT00389519|P4|Participant Flow|Ramipril High Dose|
362287|NCT00389519|P3|Participant Flow|Ramipril Mid Dose|
362288|NCT00389519|P2|Participant Flow|Ramipril Low Dose|
362289|NCT00389519|P1|Participant Flow|Placebo|
362290|NCT00389519|O4|Outcome|Ramipril High Dose|
362291|NCT00389519|O3|Outcome|Ramipril Mid Dose|
362292|NCT00389519|O2|Outcome|Ramipril Low Dose|
362293|NCT00389519|O1|Outcome|Placebo|
362294|NCT00389519|O4|Outcome|Ramipril High Dose|
362295|NCT00389519|O3|Outcome|Ramipril Mid Dose|
362296|NCT00389519|O2|Outcome|Ramipril Low Dose|
362297|NCT00389519|O1|Outcome|Placebo|
362298|NCT00389519|O4|Outcome|Ramipril High Dose|
362299|NCT00389519|O3|Outcome|Ramipril Mid Dose|
362300|NCT00389519|O2|Outcome|Ramipril Low Dose|
362301|NCT00389519|O1|Outcome|Placebo|
362302|NCT00389519|O4|Outcome|Ramipril High Dose|
362303|NCT00389519|O3|Outcome|Ramipril Mid Dose|
362304|NCT00389519|O2|Outcome|Ramipril Low Dose|
362305|NCT00389519|O1|Outcome|Placebo|
362306|NCT00389519|O4|Outcome|Ramipril High Dose|
362307|NCT00389519|O3|Outcome|Ramipril Mid Dose|
362308|NCT00389519|O2|Outcome|Ramipril Low Dose|
362309|NCT00389519|O1|Outcome|Placebo|
362310|NCT00389519|E4|Reported Event|Ramipril High Dose|
362311|NCT00389519|E3|Reported Event|Ramipril Mid Dose|
362312|NCT00389519|E2|Reported Event|Ramipril Low Dose|
362313|NCT00389519|E1|Reported Event|Placebo|
362314|NCT00389532|B3|Baseline|Total|Total of all reporting groups
362315|NCT00389532|B2|Baseline|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
362316|NCT00389532|B1|Baseline|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
362317|NCT00389532|P2|Participant Flow|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
362318|NCT00389532|P1|Participant Flow|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
362319|NCT00389532|O2|Outcome|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
362320|NCT00389532|O1|Outcome|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
362323|NCT00389532|E2|Reported Event|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
362324|NCT00389532|E1|Reported Event|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
362325|NCT00389597|B5|Baseline|Total|Total of all reporting groups
362326|NCT00389597|B4|Baseline|2 Level ACDF|
362327|NCT00389597|B3|Baseline|2 Level TDR|
362328|NCT00389597|B2|Baseline|1 Level ACDF|
362329|NCT00389597|B1|Baseline|1 Level TDR|
362330|NCT00389597|P4|Participant Flow|2 Level ACDF Arm|2 level control procedure (ACDF)
362331|NCT00389597|P3|Participant Flow|2 Level TDR Arm|Cervical artificial disc (investigational device) at 2 levels
362332|NCT00389597|P2|Participant Flow|1 Level ACDF Arm|1 level control procedure (ACDF)
362333|NCT00389597|P1|Participant Flow|1 Level TDR Arm|Cervical artificial disc (investigational device) at 1 level
362334|NCT00389597|O4|Outcome|2 Level TDR|control procedure (ACDF) at two levels
362335|NCT00389597|O3|Outcome|2 Level ACDF|Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
362336|NCT00389597|O2|Outcome|1 Level TDR|Cervical artificial disc (investigational device) at 1 level
362337|NCT00389597|O1|Outcome|1 Level ACDF|control procedure (ACDF) at one level
362338|NCT00389597|E4|Reported Event|2 Level ACDF Arm|
362339|NCT00389597|E3|Reported Event|2 Level TDR Arm|Cervical artificial disc (investigational device) at 2 levels
362340|NCT00389597|E2|Reported Event|1 Level ACDF Arm|
362341|NCT00389597|E1|Reported Event|1 Level TDR Arm|Cervical artificial disc (investigational device) at 1 level
362342|NCT00389805|B3|Baseline|Total|Total of all reporting groups
362343|NCT00389805|B2|Baseline|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362344|NCT00389805|B1|Baseline|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362345|NCT00389805|P2|Participant Flow|Arm B|Pemetrexed on day 1 (500 -600 mg/m2 IV) and bortezomib twice weekly (0.7-1.3mg/m2) on days 1 and 8 every 21 days
362346|NCT00389805|P1|Participant Flow|Arm A|Pemetrexed on day 1 (500 -600 mg/m2 IV) and bortezomib twice weekly (0.7-1.3mg/m3) on days 1, 4, 8, and 11 every 21 days
362347|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362348|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362349|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362350|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362351|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362352|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362353|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362354|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362355|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362356|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
363428|NCT00392678|O1|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
362360|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362361|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362362|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362363|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362364|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362365|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362366|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362367|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362368|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362369|NCT00389805|E2|Reported Event|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
362370|NCT00389805|E1|Reported Event|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
362371|NCT00389818|B1|Baseline|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
362372|NCT00389818|P1|Participant Flow|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
362373|NCT00389818|O1|Outcome|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
362374|NCT00389818|E1|Reported Event|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
362375|NCT00389831|B3|Baseline|Total|Total of all reporting groups
362376|NCT00389831|B2|Baseline|Rotigotine Nasal Spray|Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
362377|NCT00389831|B1|Baseline|Placebo|Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
362378|NCT00389831|P2|Participant Flow|Rotigotine Nasal Spray|Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
362379|NCT00389831|P1|Participant Flow|Placebo|Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
362380|NCT00389831|O8|Outcome|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
362381|NCT00389831|O7|Outcome|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
362504|NCT00390468|B1|Baseline|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
362382|NCT00389831|O6|Outcome|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
362383|NCT00389831|O5|Outcome|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
362384|NCT00389831|O4|Outcome|Placebo - Day 4|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.
362385|NCT00389831|O3|Outcome|Placebo - Day 3|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.
362386|NCT00389831|O2|Outcome|Placebo - Day 2|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.
362387|NCT00389831|O1|Outcome|Placebo - Day 1|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.
362388|NCT00389831|O8|Outcome|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
362389|NCT00389831|O7|Outcome|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
362390|NCT00389831|O6|Outcome|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
362391|NCT00389831|O5|Outcome|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
362392|NCT00389831|O4|Outcome|Placebo - Day 4|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.
362393|NCT00389831|O3|Outcome|Placebo - Day 3|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.
362394|NCT00389831|O2|Outcome|Placebo - Day 2|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.
362395|NCT00389831|O1|Outcome|Placebo - Day 1|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.
362396|NCT00389831|E8|Reported Event|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
362397|NCT00389831|E7|Reported Event|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
362398|NCT00389831|E6|Reported Event|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
362399|NCT00389831|E5|Reported Event|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
362400|NCT00389831|E4|Reported Event|Placebo - Day 4|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 4.
362401|NCT00389831|E3|Reported Event|Placebo - Day 3|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 3.
362402|NCT00389831|E2|Reported Event|Placebo - Day 2|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 2.
362403|NCT00389831|E1|Reported Event|Placebo - Day 1|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 1.
362404|NCT00389857|B3|Baseline|Total|Total of all reporting groups
362405|NCT00389857|B2|Baseline|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
362406|NCT00389857|B1|Baseline|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
362407|NCT00389857|P2|Participant Flow|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
362408|NCT00389857|P1|Participant Flow|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
362409|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
362410|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
362411|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
362412|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
362413|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
362414|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
362415|NCT00389857|E2|Reported Event|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
362416|NCT00389857|E1|Reported Event|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
362417|NCT00389974|B1|Baseline|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
sunitinib malate: Given PO"
362418|NCT00389974|P1|Participant Flow|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
sunitinib malate: Given PO"
362419|NCT00389974|O1|Outcome|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
sunitinib malate: Given PO"
362505|NCT00390468|P1|Participant Flow|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
364890|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
362420|NCT00389974|E1|Reported Event|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
sunitinib malate: Given PO"
362421|NCT00390013|B4|Baseline|Total|Total of all reporting groups
362422|NCT00390013|B3|Baseline|Placebo (Phase 1)|
362423|NCT00390013|B2|Baseline|Gabapentin (Phase 1)|
362424|NCT00390013|B1|Baseline|All Cross Over Participants|"Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)
Gabapentin: 300 mg. capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
day 1 you will take 1 capsule for the day
day 2 you will take 1 capsule 2 times for that day
days 3-6 you will take 1 capsule 3 times for those days
days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
days 13-14 you will take 2 capsules 3 times each day
continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
at completion of study treatment you will titrate off study drug over a weeks time.
Placebo:
Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (Gabapentin)."
362425|NCT00390013|P4|Participant Flow|Placebo Control Arm|1 phase Placebo
362426|NCT00390013|P3|Participant Flow|Treatment Only (Gabapentin)|1st phase (placebo controlled study) gabapentin 1800 mg max dose
362427|NCT00390013|P2|Participant Flow|Placebo Oral Capsule First Then Gabapentin Crossover|"Placebo titration and dosing for total of 8 weeks (Cross over)
Placebo oral capsule: Placebo capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
day 1 you will take 1 capsule for the day
day 2 you will take 1 capsule 2 times for that day
days 3-6 you will take 1 capsule 3 times for those days
days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
days 13-14 you will take 2 capsules 3 times each day
continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2.
at completion of study treatment (week 11) you will titrate off study drug over a weeks time.
Gabapentin: 300 mg. capsules Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (placebo)."
362428|NCT00390013|P1|Participant Flow|Gabapentin First Then Placebo Crossover|"Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)
Gabapentin: 300 mg. capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
day 1 you will take 1 capsule for the day
day 2 you will take 1 capsule 2 times for that day
days 3-6 you will take 1 capsule 3 times for those days
days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
days 13-14 you will take 2 capsules 3 times each day
continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
at completion of cross-over period 1 you will titrate off study drug over a weeks time.
Placebo:
Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (gabapentin)."
362429|NCT00390013|O2|Outcome|Placebo|
362430|NCT00390013|O1|Outcome|Gabapentin|
362466|NCT00390234|P1|Participant Flow|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
362467|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV"
362635|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362431|NCT00390013|E2|Reported Event|Placebo Oral Capsule|"Placebo titration and dosing for total of 8 weeks (Cross over)
Placebo oral capsule: Placebo capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
day 1 you will take 1 capsule for the day
day 2 you will take 1 capsule 2 times for that day
days 3-6 you will take 1 capsule 3 times for those days
days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
days 13-14 you will take 2 capsules 3 times each day
continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
at completion of study treatment you will titrate off study drug over a weeks time."
362432|NCT00390013|E1|Reported Event|Gabapentin|"Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)
Gabapentin: 300 mg. capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
day 1 you will take 1 capsule for the day
day 2 you will take 1 capsule 2 times for that day
days 3-6 you will take 1 capsule 3 times for those days
days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
days 13-14 you will take 2 capsules 3 times each day
continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
at completion of study treatment you will titrate off study drug over a weeks time."
362433|NCT00390182|B1|Baseline|Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra|
362434|NCT00390182|P1|Participant Flow|Gem(1250mg/m2, d1, 8) +LDFRT (60cGy/fx BID, d1,2,8,9)|4 cycles (1 cycle = 21 days): Gemcitabine 1250/m2 given IV Day 1 and Day 8; with concurrent Low Dose Fractionated Radiation Therapy (LDFRT). The total Radiation dose would be 19.2 Gy divided over 32 fractions. Treatment will be given in 2 fractions with a minimum 4 hr inter-fraction interval, not to exceed 6 hours. Radiotherapy given after the initiation of Gemcitabine Days 1,2,8, and 9.
362435|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
362436|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
362506|NCT00390468|O1|Outcome|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
363024|NCT00391625|O4|Outcome|GA-GCB-48 Months|15-60 U/kg, every other week Intravenously
362437|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
362438|NCT00390182|E1|Reported Event|Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra|
362439|NCT00390221|B4|Baseline|Total|Total of all reporting groups
362440|NCT00390221|B3|Baseline|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362441|NCT00390221|B2|Baseline|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362442|NCT00390221|B1|Baseline|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
362443|NCT00390221|P3|Participant Flow|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362444|NCT00390221|P2|Participant Flow|150 mg DAC HYP|150 mg Daclizumab High Yield Process (DAC HYP) administered as 3 SC injections every 4 weeks for up to 52 weeks
362445|NCT00390221|P1|Participant Flow|Placebo|Placebo administered as 3 subcutaneous (SC) injections every 4 weeks for up to 52 weeks
362446|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362447|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362448|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
362449|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362450|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362451|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
362452|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362453|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362454|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
362455|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362456|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362457|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
362458|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362459|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362460|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
362461|NCT00390221|E4|Reported Event|Total Active|150 mg or 300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362462|NCT00390221|E3|Reported Event|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362463|NCT00390221|E2|Reported Event|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
362464|NCT00390221|E1|Reported Event|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
362465|NCT00390234|B1|Baseline|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
362531|NCT00390572|B3|Baseline|Total|Total of all reporting groups
362468|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV"
362469|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV"
362470|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV"
362471|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
362472|NCT00390234|E1|Reported Event|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
362473|NCT00390364|B1|Baseline|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
362474|NCT00390364|P1|Participant Flow|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
362475|NCT00390364|O1|Outcome|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
362507|NCT00390468|E1|Reported Event|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
362508|NCT00390546|B3|Baseline|Total|Total of all reporting groups
364891|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
362476|NCT00390364|E1|Reported Event|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
362477|NCT00390416|B1|Baseline|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
362478|NCT00390416|P1|Participant Flow|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|"Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin: Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes"
362479|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
362480|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
362481|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
362482|NCT00390416|E1|Reported Event|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
362483|NCT00390455|B3|Baseline|Total|Total of all reporting groups
362484|NCT00390455|B2|Baseline|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
362485|NCT00390455|B1|Baseline|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
362486|NCT00390455|P2|Participant Flow|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
362487|NCT00390455|P1|Participant Flow|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
362488|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
362489|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
362490|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
362491|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
362492|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
362532|NCT00390572|B2|Baseline|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
362493|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
362494|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
362495|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
362496|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
362497|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
362498|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
362499|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
362500|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
362501|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
362502|NCT00390455|E2|Reported Event|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
362503|NCT00390455|E1|Reported Event|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
362509|NCT00390546|B2|Baseline|Propranolol|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
362510|NCT00390546|B1|Baseline|Digoxin|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
362511|NCT00390546|P2|Participant Flow|Propranolol|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
362512|NCT00390546|P1|Participant Flow|Digoxin|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
362513|NCT00390546|O2|Outcome|Propranolol|Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
362514|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
362515|NCT00390546|O2|Outcome|Propranolol|Single dose administered orally at 0.5/kg per dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
362516|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
362517|NCT00390546|O2|Outcome|Propranolol|Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
362518|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
362519|NCT00390546|E2|Reported Event|Propranolol|
362520|NCT00390546|E1|Reported Event|Digoxin|
362521|NCT00390559|B1|Baseline|All Participants|In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.
362522|NCT00390559|P1|Participant Flow|All Participants|In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.
362523|NCT00390559|O4|Outcome|PlaceboP/PlaceboC|0 mg patch/no nicotine cigarette
362524|NCT00390559|O3|Outcome|Active P/PlaceboC|21 mg patch/no nicotine cigarette
362525|NCT00390559|O2|Outcome|PlaceboP/ActiveC|0 mg patch/nicotine-containing cigarette
362526|NCT00390559|O1|Outcome|ActiveP/ActiveC|21 mg patch/Nicotine-containing cigarette
362527|NCT00390559|E4|Reported Event|PlaceboP/PlaceboC|0 mg patch/no nicotine cigarette
362528|NCT00390559|E3|Reported Event|Active P/PlaceboC|21 mg patch/no nicotine cigarette
362529|NCT00390559|E2|Reported Event|PlaceboP/ActiveC|0 mg patch/nicotine-containing cigarette
362530|NCT00390559|E1|Reported Event|ActiveP/ActiveC|21 mg patch/Nicotine-containing cigarette
362533|NCT00390572|B1|Baseline|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study
Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
362534|NCT00390572|P2|Participant Flow|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
362535|NCT00390572|P1|Participant Flow|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study
Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants' primary care providers."
362536|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
362537|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study
Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
362538|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
362563|NCT00390689|B4|Baseline|Total|Total of all reporting groups
362656|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362657|NCT00390780|E2|Reported Event|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362539|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study
Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
362540|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
362541|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study
Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
362542|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
362543|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study
Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
362544|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
362545|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study
Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
362546|NCT00390572|E2|Reported Event|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
362547|NCT00390572|E1|Reported Event|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study
Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
362548|NCT00390611|B3|Baseline|Total|Total of all reporting groups
362549|NCT00390611|B2|Baseline|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin"
362550|NCT00390611|B1|Baseline|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Sorafenib
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin"
362551|NCT00390611|P2|Participant Flow|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
362552|NCT00390611|P1|Participant Flow|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
362553|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
362554|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
362555|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
362556|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
362557|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
362558|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
362559|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin"
362560|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Sorafenib
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin"
362561|NCT00390611|E2|Reported Event|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin"
362562|NCT00390611|E1|Reported Event|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Sorafenib
Paclitaxel: Paclitaxel
Carboplatin: Carboplatin"
362564|NCT00390689|B3|Baseline|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362565|NCT00390689|B2|Baseline|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362566|NCT00390689|B1|Baseline|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362567|NCT00390689|P3|Participant Flow|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362578|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362636|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362568|NCT00390689|P2|Participant Flow|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362569|NCT00390689|P1|Participant Flow|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362570|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362649|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362650|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
364892|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
362571|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362572|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362573|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362574|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362575|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362576|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362577|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362632|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362579|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362580|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362581|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362651|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362652|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362653|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362654|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362582|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362583|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362584|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362585|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362586|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362587|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362588|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362589|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
363080|NCT00391768|P4|Participant Flow|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
362590|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362591|NCT00390689|O3|Outcome|Pramipexole 0.50mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362592|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362593|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362594|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362595|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362596|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362597|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362598|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362599|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362633|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362634|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362600|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362601|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362655|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362602|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362603|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362604|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362605|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362606|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362607|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362608|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362609|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362610|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362611|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362612|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362613|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362614|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362615|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362616|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362617|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
364893|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
362618|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily
Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362619|NCT00390689|E7|Reported Event|Pramipexole 0.75mg (Open Label)|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362620|NCT00390689|E6|Reported Event|Pramipexole 0.50mg (Open Label)|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362621|NCT00390689|E5|Reported Event|Pramipexole 0.25mg (Open Label)|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362622|NCT00390689|E4|Reported Event|Pramipexole 0.125mg (Open Label)|"Open-label period:
Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.
The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
362623|NCT00390689|E3|Reported Event|Pramipexole 0.75mg (Double-blind)|"Double-blind period: 0.75 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily"
362624|NCT00390689|E2|Reported Event|Pramipexole 0.50mg (Double-blind)|"Double-blind period: 0.5 mg randomised group
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily"
362625|NCT00390689|E1|Reported Event|Pramipexole 0.25mg (Double-blind)|"Double-blind period: 0.25 mg randomised group.
Administration as follows:
Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily"
362626|NCT00390780|B3|Baseline|Total|Total of all reporting groups
362627|NCT00390780|B2|Baseline|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362628|NCT00390780|B1|Baseline|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362629|NCT00390780|P2|Participant Flow|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day, for 14 days
362630|NCT00390780|P1|Participant Flow|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362631|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362637|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362638|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362639|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362640|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362641|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362642|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362643|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362644|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362645|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362646|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362647|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
362648|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
364894|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
362658|NCT00390780|E1|Reported Event|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
362659|NCT00390806|B3|Baseline|Total|Total of all reporting groups
362660|NCT00390806|B2|Baseline|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362661|NCT00390806|B1|Baseline|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362662|NCT00390806|P2|Participant Flow|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362663|NCT00390806|P1|Participant Flow|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362664|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362665|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362666|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362667|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362668|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362669|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362670|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362671|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362672|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362673|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362674|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362675|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362676|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362677|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362678|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362679|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362680|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362681|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362682|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362742|NCT00390858|E1|Reported Event|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
362743|NCT00390884|B3|Baseline|Total|Total of all reporting groups
362683|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362684|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362685|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362686|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362687|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362688|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362689|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362690|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362691|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362692|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362693|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362694|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362695|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362696|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362744|NCT00390884|B2|Baseline|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362834|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
362697|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362698|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362699|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362700|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362701|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362702|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362703|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362704|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362705|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362706|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362707|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362708|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362709|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362710|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362745|NCT00390884|B1|Baseline|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362835|NCT00385216|E2|Reported Event|Placebo|Sterile saline nasal spray was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
362711|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362712|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362713|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362714|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362715|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362716|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362717|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362718|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362719|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362720|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362721|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362722|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362723|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362724|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362746|NCT00390884|P2|Participant Flow|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362836|NCT00385216|E1|Reported Event|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
362725|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362726|NCT00390806|E2|Reported Event|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
362727|NCT00390806|E1|Reported Event|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
362728|NCT00390858|B3|Baseline|Total|Total of all reporting groups
362729|NCT00390858|B2|Baseline|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362730|NCT00390858|B1|Baseline|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362783|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
363025|NCT00391625|O3|Outcome|GA-GCB: 36 Months|15-60 U/kg, every other week Intravenously
362731|NCT00390858|P2|Participant Flow|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362732|NCT00390858|P1|Participant Flow|Children ( < 12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362733|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362734|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362735|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362736|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362737|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362738|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362739|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362740|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
362741|NCT00390858|E2|Reported Event|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
362837|NCT00385268|B3|Baseline|Total|Total of all reporting groups
362747|NCT00390884|P1|Participant Flow|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362748|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362749|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362750|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362751|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362752|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362753|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362754|NCT00390884|E2|Reported Event|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362755|NCT00390884|E1|Reported Event|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
362756|NCT00385138|B3|Baseline|Total|Total of all reporting groups
362757|NCT00385138|B2|Baseline|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362966|NCT00391222|O1|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
362758|NCT00385138|B1|Baseline|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362759|NCT00385138|P2|Participant Flow|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362760|NCT00385138|P1|Participant Flow|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362761|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362762|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362763|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362764|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362765|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362766|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362767|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362768|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362769|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362770|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362771|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362772|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362773|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362833|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
362774|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362775|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362776|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362777|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362778|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362779|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362780|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362781|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362782|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362784|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362785|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362786|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362787|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362788|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362789|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362790|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362791|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362792|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362793|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362794|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362795|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362796|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362797|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362798|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362799|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362800|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362801|NCT00385138|E2|Reported Event|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
362802|NCT00385138|E1|Reported Event|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
362803|NCT00385203|B3|Baseline|Total|Total of all reporting groups
362804|NCT00385203|B2|Baseline|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day: 10 patients with Soft Tissue Sarcomas (STS) randomised
362805|NCT00385203|B1|Baseline|Cediranib 45 mg/Day GIST|Cediranib 45 mg/Day: 25 patients with Gastrointestinal Stromal Tumour (GIST) randomised
362806|NCT00385203|P2|Participant Flow|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
362807|NCT00385203|P1|Participant Flow|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
362808|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
362809|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
362810|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
362811|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
362812|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
363023|NCT00391625|O5|Outcome|GA-GCB: 60 Months|15-60 U/kg, every other week Intravenously
362813|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
362814|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
362815|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
362816|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
362817|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
362818|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
362819|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
362820|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment
362821|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
362822|NCT00385203|E2|Reported Event|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment.
362823|NCT00385203|E1|Reported Event|Cediranib 45 mg/Day GIST|Cediranib 45 mg/Day patients with Gastrointestinal Stromal Tumour (GIST): 24 patients randomised and received at least one dose of treatment (1 patient was not randomised or dosed and a further 1 patient was randomised but not dosed due to Incorrect enrolmentCediranib)
362824|NCT00385216|B1|Baseline|Entire Study Population|The baseline characteristics for the entire study population are presented here. The nicotine and placebo study populations were identical.
362825|NCT00385216|P2|Participant Flow|Placebo Spray First, Then Nicotine|At the first intervention, the subject will receive a placebo nasal spray, 0 mg, one application. At the second intervention, the subject will receive a nicotine nasal spray, 3 mg, one application.
362826|NCT00385216|P1|Participant Flow|Nicotine Nasal Spray First, Then Placebo|At the first intervention, the subject will receive a nicotine nasal spray, 3 mg, one application. At the second intervention, the subject will receive a placebo nasal spray, 0 mg, one application.
362827|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
362828|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
362829|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
362830|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
362831|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
362832|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
362838|NCT00385268|B2|Baseline|Placebo|"placebo pills for 8 weeks
Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.
placebo : placebo pills"
362839|NCT00385268|B1|Baseline|Acamprosate|"1998mg/day for 8 weeks
Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.
acamprosate : 1998 mg/dau fpr 8 weeks"
362840|NCT00385268|P2|Participant Flow|Placebo|"placebo pills for 8 weeks
Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.
placebo : placebo pills"
362841|NCT00385268|P1|Participant Flow|Acamprosate|"1998mg/day for 8 weeks
Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.
acamprosate : 1998 mg/dau fpr 8 weeks"
362842|NCT00385268|O2|Outcome|Placebo|"placebo pills for 8 weeks
Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.
placebo : placebo pills"
362843|NCT00385268|O1|Outcome|Acamprosate|"1998mg/day for 8 weeks
Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.
acamprosate : 1998 mg/dau fpr 8 weeks"
362844|NCT00385268|E2|Reported Event|Placebo|"placebo pills for 8 weeks
Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.
placebo : placebo pills"
362845|NCT00385268|E1|Reported Event|Acamprosate|"1998mg/day for 8 weeks
Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.
acamprosate : 1998 mg/dau fpr 8 weeks"
362846|NCT00391027|B3|Baseline|Total|Total of all reporting groups
362847|NCT00391027|B2|Baseline|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362859|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362848|NCT00391027|B1|Baseline|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362849|NCT00391027|P2|Participant Flow|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362850|NCT00391027|P1|Participant Flow|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362851|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362852|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362853|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362854|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362855|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362901|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
362902|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
362856|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362857|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362858|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362919|NCT00391079|P2|Participant Flow|Placebo|Range of 8-12 sprays per day of placebo spray.
362920|NCT00391079|P1|Participant Flow|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
362921|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
362860|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362861|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362862|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362863|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362864|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362865|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362866|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362867|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362903|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
362904|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
362868|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362869|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362870|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362871|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362872|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362873|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362874|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362875|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362876|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362877|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362878|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362879|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362905|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
362999|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
362880|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362881|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362882|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362883|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362884|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362885|NCT00391027|E2|Reported Event|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
362886|NCT00391027|E1|Reported Event|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
362887|NCT00391053|B5|Baseline|Total|Total of all reporting groups
362888|NCT00391053|B4|Baseline|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
362889|NCT00391053|B3|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
362890|NCT00391053|B2|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
362891|NCT00391053|B1|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
362892|NCT00391053|P4|Participant Flow|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
362893|NCT00391053|P3|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
362894|NCT00391053|P2|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
362895|NCT00391053|P1|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
362896|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
362897|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
362898|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
362899|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
362900|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
363075|NCT00391768|B2|Baseline|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
362906|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
362907|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
362908|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
362909|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
362910|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
362911|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
362912|NCT00391053|E4|Reported Event|Standad Dose Inactivated, Split-Virion Influenza Vaccine|
362913|NCT00391053|E3|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|
362914|NCT00391053|E2|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|
362915|NCT00391053|E1|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|
362916|NCT00391079|B3|Baseline|Total|Total of all reporting groups
362917|NCT00391079|B2|Baseline|Placebo|Range of 8-12 sprays per day of placebo spray.
362918|NCT00391079|B1|Baseline|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
362922|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
362923|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
362924|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
362925|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
362926|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
362927|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
362928|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
362929|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
362930|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
362931|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
362932|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
362933|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
362934|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
362935|NCT00391079|E2|Reported Event|Placebo|Range of 8-12 sprays of placebo per day
362936|NCT00391079|E1|Reported Event|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
362937|NCT00391092|B3|Baseline|Total|Total of all reporting groups
362938|NCT00391092|B2|Baseline|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
362939|NCT00391092|B1|Baseline|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
362940|NCT00391092|P2|Participant Flow|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
362996|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
362997|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
362941|NCT00391092|P1|Participant Flow|Trastuzumab + Docetaxel|Trastuzumab 8 milligrams per kilogram (mg/kg) loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 milligrams per square meter (mg/m^2) on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
362942|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
362943|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
362944|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
362945|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
362965|NCT00391222|P1|Participant Flow|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
362946|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
362947|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
362948|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
362949|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
362950|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
362951|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
362952|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
362953|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
362954|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
362998|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
363076|NCT00391768|B1|Baseline|Cohort IA|12 - 23 months of age, 30 mg
362955|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
362956|NCT00391092|E2|Reported Event|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
362957|NCT00391092|E1|Reported Event|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
362958|NCT00391222|B4|Baseline|Total|Total of all reporting groups
362959|NCT00391222|B3|Baseline|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine 10 mg/day
362960|NCT00391222|B2|Baseline|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
362961|NCT00391222|B1|Baseline|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable intramuscular every 14 days and oral placebo daily
362962|NCT00391222|P4|Participant Flow|Open-label Risperidone LAI|Open-label Period II: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days
362963|NCT00391222|P3|Participant Flow|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
362964|NCT00391222|P2|Participant Flow|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
364895|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
362967|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
362968|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
362969|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
362970|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
362971|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
362972|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
362973|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
362974|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
362975|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
362976|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
362977|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
362978|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
362979|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
362980|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
362981|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
362982|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
362983|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
362984|NCT00391222|E4|Reported Event|Open-label Risperidone LAI|risperidone 25, 37.5, or 50 mg intramuscular every 14 days
362985|NCT00391222|E3|Reported Event|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
362986|NCT00391222|E2|Reported Event|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
362987|NCT00391222|E1|Reported Event|Risperidone LAI|Double-blind Period III: risperidone LAI 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
362988|NCT00391274|B3|Baseline|Total|Total of all reporting groups
362989|NCT00391274|B2|Baseline|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
362990|NCT00391274|B1|Baseline|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
362991|NCT00391274|P2|Participant Flow|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
362992|NCT00391274|P1|Participant Flow|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
362993|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
362994|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
362995|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
363077|NCT00391768|P7|Participant Flow|Cohort V|0 to 2 months of age, 3 mg/kg body weight
363000|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
363001|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
363002|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
363003|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
363004|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
363005|NCT00391274|E2|Reported Event|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
363006|NCT00391274|E1|Reported Event|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
363007|NCT00391625|B1|Baseline|GA-GCB|15-60 U/kg every other week via intravenous infusion
363008|NCT00391625|P1|Participant Flow|GA-GCB|15-60 U/kg every other week via intravenous infusion
363009|NCT00391625|O6|Outcome|GA-GCB: Month 81|15-60 U/kg, every other week Intravenously
363010|NCT00391625|O5|Outcome|GA-GCB: Month 69|15-60 U/kg, every other week Intravenously
363011|NCT00391625|O4|Outcome|GA-GCB: Month 57|15-60 U/kg, every other week Intravenously
363012|NCT00391625|O3|Outcome|GA-GCB: Month 45|15-60 U/kg, every other week Intravenously
363013|NCT00391625|O2|Outcome|GA-GCB: Month 33|15-60 U/kg, every other week Intravenously
363014|NCT00391625|O1|Outcome|GA-GCB: Month 24|15-60 U/kg, every other week Intravenously
363015|NCT00391625|O6|Outcome|GA-GCB: Month 81|15-60 U/kg, every other week Intravenously
363016|NCT00391625|O5|Outcome|GA-GCB: Month 69|15-60 U/kg, every other week Intravenously
363017|NCT00391625|O4|Outcome|GA-GCB: Month 57|15-60 U/kg, every other week Intravenously
363018|NCT00391625|O3|Outcome|GA-GCB: Month 45|15-60 U/kg, every other week Intravenously
363019|NCT00391625|O2|Outcome|GA-GCB: Month 33|15-60 U/kg, every other week Intravenously
363020|NCT00391625|O1|Outcome|GA-GCB: Month 24|15-60 U/kg, every other week Intravenously
363021|NCT00391625|O7|Outcome|GA-GCB: 84 Months|15-60 U/kg, every other week Intravenously
363022|NCT00391625|O6|Outcome|GA-GCB: 72 Months|15-60 U/kg, every other week Intravenously
363026|NCT00391625|O2|Outcome|GA-GCB: 24 Months|15-60 U/kg, every other week Intravenously
363027|NCT00391625|O1|Outcome|GA-GCB: 12 Months|15-60 U/kg, every other week Intravenously
363028|NCT00391625|O7|Outcome|GA-GCB: 84 Months|15-60 U/kg, every other week Intravenously
363029|NCT00391625|O6|Outcome|GA-GCB: 72 Months|15-60 U/kg, every other week Intravenously
363030|NCT00391625|O5|Outcome|GA-GCB: 60 Months|15-60 U/kg, every other week Intravenously
363031|NCT00391625|O4|Outcome|GA-GCB-48 Months|15-60 U/kg, every other week Intravenously
363032|NCT00391625|O3|Outcome|GA-GCB: 36 Months|15-60 U/kg, every other week Intravenously
363033|NCT00391625|O2|Outcome|GA-GCB: 24 Months|15-60 U/kg, every other week Intravenously
363034|NCT00391625|O1|Outcome|GA-GCB: 12 Months|15-60 U/kg, every other week Intravenously
363035|NCT00391625|O11|Outcome|# Deaths|
363036|NCT00391625|O10|Outcome|# Discontinued Due to an AE|15-60 U/kg, every other week Intravenously
363037|NCT00391625|O9|Outcome|# Experienced at Least 1 Drug-related Serious AE|15-60 U/kg, every other week Intravenously
363038|NCT00391625|O8|Outcome|# Experienced at Least 1 Serious AE|15-60 U/kg, every other week Intravenously
363039|NCT00391625|O7|Outcome|# Experienced at Least 1 Life-threatening AE|15-60 U/kg, every other week Intravenously
363040|NCT00391625|O6|Outcome|# Experienced at Least 1 Drug-related Severe AE|15-60 U/kg, every other week Intravenously
363041|NCT00391625|O5|Outcome|# Experienced at Least 1 Severe AE|15-60 U/kg, every other week Intravenously
363042|NCT00391625|O4|Outcome|# Experienced at Least 1 Infusion-related AE|15-60 U/kg, every other week Intravenously
363043|NCT00391625|O3|Outcome|# Experienced at Least 1 Drug-related AE|15-60 U/kg, every other week Intravenously
363044|NCT00391625|O2|Outcome|# Experienced at Least 1 AE|15-60 U/kg, every other week Intravenously
363045|NCT00391625|O1|Outcome|Number (#) Experienced no Adverse Event (AE)|15-60 U/kg every other week via intravenous infusion
363046|NCT00391625|E1|Reported Event|GA-GCB|
363047|NCT00391716|B4|Baseline|Total|Total of all reporting groups
363048|NCT00391716|B3|Baseline|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules"
363049|NCT00391716|B2|Baseline|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
363050|NCT00391716|B1|Baseline|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
363051|NCT00391716|P3|Participant Flow|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules"
363078|NCT00391768|P6|Participant Flow|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
363079|NCT00391768|P5|Participant Flow|Cohort III|6 to 8 months of age, 3 mg/kg body weight
363052|NCT00391716|P2|Participant Flow|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
363053|NCT00391716|P1|Participant Flow|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
363054|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules"
363055|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
363056|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
363057|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules"
363058|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
363102|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
363103|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
363104|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
363059|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
363060|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules"
363061|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
363062|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
363063|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules"
363064|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
363065|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
363066|NCT00391716|E3|Reported Event|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules"
363067|NCT00391716|E2|Reported Event|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
363068|NCT00391716|E1|Reported Event|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
363069|NCT00391768|B8|Baseline|Total|Total of all reporting groups
363070|NCT00391768|B7|Baseline|Cohort V|0 to 2 months of age, 3 mg/kg body weight
363071|NCT00391768|B6|Baseline|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
363072|NCT00391768|B5|Baseline|Cohort III|6 to 8 months of age, 3 mg/kg body weight
363073|NCT00391768|B4|Baseline|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
363074|NCT00391768|B3|Baseline|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
363081|NCT00391768|P3|Participant Flow|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
363082|NCT00391768|P2|Participant Flow|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
363083|NCT00391768|P1|Participant Flow|Cohort IA|12 - 23 months of age, 30 mg
363084|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
363085|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
363086|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
363087|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
363088|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
363089|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
363090|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
363091|NCT00391768|O7|Outcome|Cohort V|Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
363092|NCT00391768|O6|Outcome|Cohort IV|Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
363093|NCT00391768|O5|Outcome|Cohort III|Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
363094|NCT00391768|O4|Outcome|Cohort IIB|Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
363095|NCT00391768|O3|Outcome|Cohort IIA|Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
363096|NCT00391768|O2|Outcome|Cohort IB|Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
363097|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
363098|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
363099|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
363100|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
363101|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
363105|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
363106|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
363107|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
363108|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
363109|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
363110|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
363111|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
363112|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
363113|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
363114|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
363115|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
363116|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
363117|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
363118|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
363119|NCT00391768|O7|Outcome|Cohort V|Subjects aged 0 - 2 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
363120|NCT00391768|O6|Outcome|Cohort IV|Subjects aged 3 - 5 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
363121|NCT00391768|O5|Outcome|Cohort III|Subjects aged 6 - 8 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
363122|NCT00391768|O4|Outcome|Cohort IIB|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
363123|NCT00391768|O3|Outcome|Cohort IIA|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
363124|NCT00391768|O2|Outcome|Cohort IB|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days
363125|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 30 mg of Oseltamivir twice a day times 5 days
363126|NCT00391768|O7|Outcome|Cohort V|Subjects aged 0 - 2 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
363127|NCT00391768|O6|Outcome|Cohort IV|Subjects aged 3 - 5 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
363128|NCT00391768|O5|Outcome|Cohort III|Subjects aged 6 - 8 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days.
363129|NCT00391768|O4|Outcome|Cohort IIB|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
363130|NCT00391768|O3|Outcome|Cohort IIA|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days.
363131|NCT00391768|O2|Outcome|Cohort IB|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
363132|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 30 mg of Oseltamivir twice a day times 5 days.
363169|NCT00391846|B1|Baseline|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
363133|NCT00391768|O7|Outcome|Cohort V|Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
363134|NCT00391768|O6|Outcome|Cohort IV|Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
363135|NCT00391768|O5|Outcome|Cohort III|Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
363136|NCT00391768|O4|Outcome|Cohort IIB|Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
363137|NCT00391768|O3|Outcome|Cohort IIA|Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
363138|NCT00391768|O2|Outcome|Cohort IB|Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
363139|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
363140|NCT00391768|E7|Reported Event|Cohort V|0 to 2 months of age, 3 mg/kg body weight
363141|NCT00391768|E6|Reported Event|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
363142|NCT00391768|E5|Reported Event|Cohort III|6 to 8 months of age, 3 mg/kg body weight
363143|NCT00391768|E4|Reported Event|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
363144|NCT00391768|E3|Reported Event|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
363145|NCT00391768|E2|Reported Event|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
363146|NCT00391768|E1|Reported Event|Cohort IA|12 - 23 months of age, 30 mg
363147|NCT00391807|B1|Baseline|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363148|NCT00391807|P1|Participant Flow|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363149|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363190|NCT00391872|B3|Baseline|Total|Total of all reporting groups
363191|NCT00391872|B2|Baseline|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363150|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363151|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363152|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363153|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363154|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363155|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363156|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363157|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363158|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363159|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363160|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363161|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363162|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363163|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363164|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363165|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363166|NCT00391807|E1|Reported Event|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
363167|NCT00391846|B3|Baseline|Total|Total of all reporting groups
363168|NCT00391846|B2|Baseline|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
363170|NCT00391846|P2|Participant Flow|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
363171|NCT00391846|P1|Participant Flow|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
363172|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
363173|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
363174|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
363175|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
363176|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
363177|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
363178|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
363179|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
363180|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
363181|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
363182|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
363183|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
363184|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
363185|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
363186|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
363187|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
363188|NCT00391846|E2|Reported Event|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
363189|NCT00391846|E1|Reported Event|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
363192|NCT00391872|B1|Baseline|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363193|NCT00391872|P2|Participant Flow|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363194|NCT00391872|P1|Participant Flow|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363195|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363196|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363197|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363198|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363199|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363200|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363201|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363202|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363203|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363204|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363205|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363206|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363207|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363208|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363209|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363210|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363211|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363212|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363213|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363214|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363215|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363216|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363217|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363218|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363219|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363220|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363221|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363222|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363223|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363224|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363225|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363226|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363227|NCT00391872|E2|Reported Event|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
363228|NCT00391872|E1|Reported Event|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
363229|NCT00391898|B3|Baseline|Total|Total of all reporting groups
363230|NCT00391898|B2|Baseline|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
363280|NCT00391989|E1|Reported Event|Dasatinib|All patients registered in the study.
363281|NCT00392171|B1|Baseline|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
363231|NCT00391898|B1|Baseline|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
363232|NCT00391898|P2|Participant Flow|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
363233|NCT00391898|P1|Participant Flow|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
363234|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
363235|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
363236|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
363237|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
363238|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
363239|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
363455|NCT00392808|B2|Baseline|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
363240|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
363241|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
363242|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
363243|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
363244|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
363245|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
363246|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
363247|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
363248|NCT00391898|E2|Reported Event|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
363249|NCT00391898|E1|Reported Event|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
363250|NCT00391976|B4|Baseline|Total|Total of all reporting groups
363251|NCT00391976|B3|Baseline|Non-randomized Patients|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
363252|NCT00391976|B2|Baseline|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363253|NCT00391976|B1|Baseline|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363282|NCT00392171|P1|Participant Flow|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
363254|NCT00391976|P3|Participant Flow|Non-randomized Patients|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
363255|NCT00391976|P2|Participant Flow|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363256|NCT00391976|P1|Participant Flow|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363257|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
363258|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363259|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363260|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
363261|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363262|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363329|NCT00392236|O2|Outcome|Treatment as Usual|"Participants will receive treatment as usual
Treatment as usual: Participants will receive treatment as usual."
363263|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
363264|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363265|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363266|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
363267|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363268|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363269|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
363270|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363271|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363272|NCT00391976|E5|Reported Event|Tobramycin 56 Days After Month 3|Patients received tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
363273|NCT00391976|E4|Reported Event|Tobramycin 28 Days After Month 3|Patients who received tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
363274|NCT00391976|E3|Reported Event|Non-randomized Patients up to Month 3|Patients who started the study and received tobramycin 300 mg twice a day for 28 days but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups.
363275|NCT00391976|E2|Reported Event|Tobramycin 56 Days Up To Month 3|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363276|NCT00391976|E1|Reported Event|Tobramycin 28 Days Up To Month 3|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
363277|NCT00391989|B1|Baseline|Dasatinib|All patients registered in the study.
363278|NCT00391989|P1|Participant Flow|Study Group|All patients registered in the study.
363279|NCT00391989|O1|Outcome|Study Group|All patients registered in the study.
363283|NCT00392171|O1|Outcome|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
363284|NCT00392171|E1|Reported Event|Temozolomide|
363285|NCT00392197|B3|Baseline|Total|Total of all reporting groups
363286|NCT00392197|B2|Baseline|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
363287|NCT00392197|B1|Baseline|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
363288|NCT00392197|P2|Participant Flow|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
363289|NCT00392197|P1|Participant Flow|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
363290|NCT00392197|O2|Outcome|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
363291|NCT00392197|O1|Outcome|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
363292|NCT00392197|O2|Outcome|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
363293|NCT00392197|O1|Outcome|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
363294|NCT00392197|E2|Reported Event|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
363295|NCT00392197|E1|Reported Event|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
363296|NCT00392210|B3|Baseline|Total|Total of all reporting groups
363297|NCT00392210|B2|Baseline|Back Fill Followed by Auto Fill|The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
363298|NCT00392210|B1|Baseline|Auto Fill Followed by Back Fill|The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
363299|NCT00392210|P2|Participant Flow|Back Fill Followed by Autofill|The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
363300|NCT00392210|P1|Participant Flow|Auto-fill Followed by Back Fill|The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
363301|NCT00392210|O2|Outcome|Back Fill Intervention|Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
363302|NCT00392210|O1|Outcome|Auto Fill Intervention|Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void.
363303|NCT00392210|E2|Reported Event|Back Fill|Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
363304|NCT00392210|E1|Reported Event|Auto Fill|Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void.
363305|NCT00392223|B3|Baseline|Total|Total of all reporting groups
363306|NCT00392223|B2|Baseline|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
363307|NCT00392223|B1|Baseline|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
363308|NCT00392223|P2|Participant Flow|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
363309|NCT00392223|P1|Participant Flow|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
363310|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
363311|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
363312|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
363313|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
363411|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
363314|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
363315|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
363316|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
363317|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
363318|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
363319|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
363320|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
363321|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
363322|NCT00392223|E2|Reported Event|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
363323|NCT00392223|E1|Reported Event|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
363324|NCT00392236|B3|Baseline|Total|Total of all reporting groups
363325|NCT00392236|B2|Baseline|Treatment as Usual|"Participants will receive treatment as usual
Treatment as usual: Participants will receive treatment as usual."
363326|NCT00392236|B1|Baseline|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months
2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
363327|NCT00392236|P2|Participant Flow|Treatment as Usual|"Participants will receive treatment as usual
Treatment as usual: Participants will receive treatment as usual."
363328|NCT00392236|P1|Participant Flow|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months
2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
364676|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
363330|NCT00392236|O1|Outcome|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months
2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
363331|NCT00392236|E2|Reported Event|Treatment as Usual|"Participants will receive treatment as usual
Treatment as usual: Participants will receive treatment as usual."
363332|NCT00392236|E1|Reported Event|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months
2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
363333|NCT00392288|B4|Baseline|Total|Total of all reporting groups
363334|NCT00392288|B3|Baseline|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
363335|NCT00392288|B2|Baseline|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
363336|NCT00392288|B1|Baseline|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
363337|NCT00392288|P3|Participant Flow|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
363338|NCT00392288|P2|Participant Flow|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
363339|NCT00392288|P1|Participant Flow|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
363340|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
363341|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
363342|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
363343|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
363344|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
363345|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
363346|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
363347|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
363348|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
363349|NCT00392288|E3|Reported Event|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
363350|NCT00392288|E2|Reported Event|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
363351|NCT00392288|E1|Reported Event|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
363352|NCT00392379|B3|Baseline|Total|Total of all reporting groups
363353|NCT00392379|B2|Baseline|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363412|NCT00392678|O1|Outcome|Placebo|Placebo
363413|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
363414|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
363415|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
363416|NCT00392678|O1|Outcome|Placebo|Placebo
363417|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
363354|NCT00392379|B1|Baseline|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363355|NCT00392379|P2|Participant Flow|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363356|NCT00392379|P1|Participant Flow|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363357|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363358|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363453|NCT00392808|B4|Baseline|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
363359|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363360|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363361|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363362|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363363|NCT00392379|E2|Reported Event|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363364|NCT00392379|E1|Reported Event|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
363365|NCT00392392|B1|Baseline|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
363366|NCT00392392|P1|Participant Flow|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
363418|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
363419|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
363420|NCT00392678|O1|Outcome|Placebo|Placebo
363367|NCT00392392|O1|Outcome|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
363368|NCT00392392|E1|Reported Event|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
363369|NCT00392444|B1|Baseline|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
363370|NCT00392444|P1|Participant Flow|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
363371|NCT00392444|O1|Outcome|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
363372|NCT00392444|E1|Reported Event|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
363373|NCT00392496|B1|Baseline|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
363374|NCT00392496|P1|Participant Flow|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
363375|NCT00392496|O1|Outcome|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
363376|NCT00392496|E1|Reported Event|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
363377|NCT00392665|B3|Baseline|Total|Total of all reporting groups
363378|NCT00392665|B2|Baseline|Erlotinib + Sulindac|"erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day"
363379|NCT00392665|B1|Baseline|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day"
363380|NCT00392665|P2|Participant Flow|Erlotinib + Sulindac|"erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day"
363381|NCT00392665|P1|Participant Flow|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day"
363382|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day"
363383|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day"
363384|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day"
363385|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day"
363386|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day"
363387|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day"
363388|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day"
363389|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day"
363390|NCT00392665|E2|Reported Event|Erlotinib + Sulindac|"erlotinib plus sulindac
erlotinib: Given orally once a day
Sulindac: Given orally twice a day"
363391|NCT00392665|E1|Reported Event|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab
Bevacizumab: Given intravenously on day one of each 3 week cycle
erlotinib: Given orally once a day"
363392|NCT00392678|B5|Baseline|Total|Total of all reporting groups
363393|NCT00392678|B4|Baseline|Placebo|
363394|NCT00392678|B3|Baseline|Salsalate 4.0 g/d|
363395|NCT00392678|B2|Baseline|Salsalate 3.5 g/d|
363396|NCT00392678|B1|Baseline|Salsalate 3.0 g/d|
363397|NCT00392678|P4|Participant Flow|Placebo|
363398|NCT00392678|P3|Participant Flow|Salsalate 4.0 g/d|
363399|NCT00392678|P2|Participant Flow|Salsalate 3.5 g/d|
363400|NCT00392678|P1|Participant Flow|Salsalate 3.0 g/d|
363401|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
363402|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
363403|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
363404|NCT00392678|O1|Outcome|Placebo|Placebo
363405|NCT00392678|O4|Outcome|Placebo|Placebo
363406|NCT00392678|O3|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
363407|NCT00392678|O2|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
363408|NCT00392678|O1|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
363409|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
363410|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
363429|NCT00392678|E4|Reported Event|Placebo|
363430|NCT00392678|E3|Reported Event|Salsalate 4.0 g/d|
363431|NCT00392678|E2|Reported Event|Salsalate 3.5 g/d|
363432|NCT00392678|E1|Reported Event|Salsalate 3.0 g/d|
363433|NCT00392704|B1|Baseline|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.
One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
363434|NCT00392704|P1|Participant Flow|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.
One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
363435|NCT00392704|O1|Outcome|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.
One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
363454|NCT00392808|B3|Baseline|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
363436|NCT00392704|O1|Outcome|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.
One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
363437|NCT00392704|E1|Reported Event|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.
One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
363438|NCT00392769|B1|Baseline|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
363439|NCT00392769|P1|Participant Flow|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
363440|NCT00392769|O1|Outcome|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
363441|NCT00392769|E1|Reported Event|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
363442|NCT00392782|B1|Baseline|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
363443|NCT00392782|P1|Participant Flow|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
363444|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
363445|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
363446|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
363495|NCT00392860|E2|Reported Event|Control Group|Participants will be given a new standard handrim.
363447|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
363448|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
363449|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
363450|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
363451|NCT00392782|E1|Reported Event|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
363452|NCT00392808|B5|Baseline|Total|Total of all reporting groups
363456|NCT00392808|B1|Baseline|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
363457|NCT00392808|P4|Participant Flow|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
363458|NCT00392808|P3|Participant Flow|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
363459|NCT00392808|P2|Participant Flow|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
363460|NCT00392808|P1|Participant Flow|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
363461|NCT00392808|O4|Outcome|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
363462|NCT00392808|O3|Outcome|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
363463|NCT00392808|O2|Outcome|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
363464|NCT00392808|O1|Outcome|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
363465|NCT00392808|O4|Outcome|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
363466|NCT00392808|O3|Outcome|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
363467|NCT00392808|O2|Outcome|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
363468|NCT00392808|O1|Outcome|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
363469|NCT00392808|E4|Reported Event|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
363470|NCT00392808|E3|Reported Event|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
363471|NCT00392808|E2|Reported Event|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
363472|NCT00392808|E1|Reported Event|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
363473|NCT00392821|B1|Baseline|RAD001 and Sorafenib|"RAD001 and Sorafenib
Sorafenib: Sorafenib
RAD001: RAD001"
363474|NCT00392821|P1|Participant Flow|RAD001 and Sorafenib|"RAD001 and Sorafenib
Sorafenib: Sorafenib
RAD001: RAD001"
363475|NCT00392821|O1|Outcome|RAD001 and Sorafenib|"RAD001 and Sorafenib
Sorafenib: Sorafenib
RAD001: RAD001"
363476|NCT00392821|O1|Outcome|RAD001 and Sorafenib|"RAD001 and Sorafenib
Sorafenib: Sorafenib
RAD001: RAD001"
363477|NCT00392821|E1|Reported Event|RAD001 and Sorafenib|"RAD001 and Sorafenib
Sorafenib: Sorafenib
RAD001: RAD001"
363478|NCT00392834|B3|Baseline|Total|Total of all reporting groups
363479|NCT00392834|B2|Baseline|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
363496|NCT00392860|E1|Reported Event|Natural-Fit Experiment|"Participants will have a Natural-Fit installed on their wheelchair.
Natural-Fit : Ergonomic handrim for wheelchairs"
363497|NCT00392925|B5|Baseline|Total|Total of all reporting groups
363480|NCT00392834|B1|Baseline|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
363481|NCT00392834|P2|Participant Flow|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
363482|NCT00392834|P1|Participant Flow|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
363504|NCT00392925|P2|Participant Flow|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 milligram (mg) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363596|NCT00393029|O1|Outcome|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
363597|NCT00393029|O2|Outcome|Other Metastatic Cancers|
363483|NCT00392834|O2|Outcome|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
363484|NCT00392834|O1|Outcome|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
363485|NCT00392834|E2|Reported Event|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
363486|NCT00392834|E1|Reported Event|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
363487|NCT00392860|B3|Baseline|Total|Total of all reporting groups
363488|NCT00392860|B2|Baseline|Control Group|Participants will be given a new standard handrim.
363489|NCT00392860|B1|Baseline|Natural-Fit Experiment|"Participants will have a Natural-Fit installed on their wheelchair.
Natural-Fit : Ergonomic handrim for wheelchairs"
363490|NCT00392860|P3|Participant Flow|Handrim Control Group|Participants will be given a new standard handrim.
363491|NCT00392860|P2|Participant Flow|PalmRim Experiment|"Participants will have a PalmRim handrim installed on their wheelchair. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.
Participants were to use the PalmRim handrim for a four month trial period, before returning for follow up evaluations."
363492|NCT00392860|P1|Participant Flow|Natural-Fit Experiment|"Participants will have a Natural-Fit handrim installed on their wheelchair. The Natural-Fit device was designed to directly address the shortcomings of standard handrims and to improve the standard round-tube handrims which were designed over 50 years ago.
Participants used the Natural-Fit Handrim for a four month trial period, before returning for follow up evaluations.
Natural-Fit : Ergonomic handrim for wheelchairs"
363493|NCT00392860|O2|Outcome|Handrim Control Group|Participants will be given a new standard handrim.
363494|NCT00392860|O1|Outcome|Natural-Fit Experiment|"Participants will have a Natural-Fit handrim installed on their wheelchair.
Natural-Fit : Ergonomic handrim for wheelchairs"
363498|NCT00392925|B4|Baseline|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
363499|NCT00392925|B3|Baseline|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363500|NCT00392925|B2|Baseline|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363501|NCT00392925|B1|Baseline|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363502|NCT00392925|P4|Participant Flow|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363503|NCT00392925|P3|Participant Flow|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363594|NCT00393029|P1|Participant Flow|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
363595|NCT00393029|O2|Outcome|Other Metastatic Cancers|
363505|NCT00392925|P1|Participant Flow|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered a subcutaneous injection of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not Randomized into one of the 3 treatment groups and withdrew from the study.
363506|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363507|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363508|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363509|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363510|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363511|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363512|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
363513|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363514|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363515|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363516|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
363517|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363518|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363519|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363520|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
363521|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363522|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363523|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363524|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
363525|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363526|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363527|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363528|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363529|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363530|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363531|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363532|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363533|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363534|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363535|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363536|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363537|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363625|NCT00393042|O20|Outcome|10/10 Allele: 25/30 mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
363538|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363539|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363540|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363541|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363542|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363543|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363544|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363545|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363724|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
363546|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363547|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363548|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363549|NCT00392925|O3|Outcome|Pramlintide Acetate+ Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363550|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363551|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363552|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363553|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363554|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363555|NCT00392925|O3|Outcome|Pramlintide Acetate+ Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363556|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363557|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363558|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363559|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363560|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363561|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363700|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
363562|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363563|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363564|NCT00392925|O1|Outcome|Lead-In Participants Randomized to Treatment on Day 1|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to a treatment group.
363565|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363566|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363567|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363568|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
364677|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
363569|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363570|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363571|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363572|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363573|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363574|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363575|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363576|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363577|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363578|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363579|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363580|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363581|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363582|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363583|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide Acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363584|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide Acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363626|NCT00393042|O19|Outcome|10/10 Allele: 20 mg of Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
363585|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363586|NCT00392925|E4|Reported Event|Participants Not Randomized to Group After Lead-In Period|During the 4-week lead-in period, all participants self administered a subcutaneous injection of pramlintide 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not Randomized into one of the 3 treatment groups and withdrew from the study.
363587|NCT00392925|E3|Reported Event|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363588|NCT00392925|E2|Reported Event|Pramlintide + Placebo|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363589|NCT00392925|E1|Reported Event|Placebo + Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
363590|NCT00393029|B3|Baseline|Total|Total of all reporting groups
363591|NCT00393029|B2|Baseline|Other Metastatic Cancers|
363592|NCT00393029|B1|Baseline|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
363593|NCT00393029|P2|Participant Flow|Other Metastatic Cancers|
363598|NCT00393029|O1|Outcome|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
363599|NCT00393029|O1|Outcome|Metastatic Melanoma & Other Metastatic Cancers|"Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
There are no statistical differences between the arms, therefore, they can be combined for this outcome measure."
363600|NCT00393029|E2|Reported Event|Other Metastatic Cancers|
363601|NCT00393029|E1|Reported Event|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
363602|NCT00393042|B1|Baseline|Overall Study|Participants either Adderall XR or Focalin XR for four weeks (3 dose levels and placebo) followed by four weeks (3 dose levels and placebo) of the opposite medication they received the first four weeks. Baseline Measures are based off all participants that were randomized regardless of the order they received the medication. Since we were interested in evaluating efficacy and adverse events at all dose conditions, participants were included in analysis if they received at least 2 weeks of study drug to insure that all participants had been exposed to at least one week of active drug
363603|NCT00393042|P2|Participant Flow|Adderall XR Then Focalin XR|Adderall XR first for 4 weeks (3 dose levels and placebo) then Focalin XR for 4 weeks (3 dose levels and placebo).
363604|NCT00393042|P1|Participant Flow|Focalin XR Then Adderall XR|Focalin XR first for 4 weeks (3 dose levels and placebo) then Adderall XR for 4 weeks (3 dose levels and placebo).
363605|NCT00393042|O8|Outcome|Focalin XR - 25/30mg|This is the 25/30 mg dosage week for the Focalin XR medication.
363606|NCT00393042|O7|Outcome|Focalin XR - 20 mg|This is the 20 mg dosage week for the Focalin XR medication.
363607|NCT00393042|O6|Outcome|Focalin XR - 10 mg|This is the 10 mg dosage week for the Focalin XR medication.
363608|NCT00393042|O5|Outcome|Focalin XR - Placebo|This is the Placebo dosage week for the Focalin XR medication.
363609|NCT00393042|O4|Outcome|Adderall XR - 25/30mg|This is the 25/30 mg dosage week for the Adderall XR medication.
363610|NCT00393042|O3|Outcome|Adderall XR - 20 mg|This is the 20 mg dosage week for the Adderall XR medication.
363611|NCT00393042|O2|Outcome|Adderall XR - 10 mg|This is the 10 mg dosage week for the Adderall XR medication.
363612|NCT00393042|O1|Outcome|Adderall XR - Placebo|This is the placebo dosage week for the Adderall XR medication.
363613|NCT00393042|O8|Outcome|Focalin XR - 25/30 mg|This is the 25/30 mg dosage week for the Focalin XR medication.
363614|NCT00393042|O7|Outcome|Focalin XR - 20 mg|This is the 20 mg dosage week for the Focalin XR medication.
363615|NCT00393042|O6|Outcome|Focalin - 10 mg|This is the 10 mg dosage week for the Focalin XR medication.
363616|NCT00393042|O5|Outcome|Focalin XR - Placebo|This is the placebo dosage week for the Focalin XR medication.
363617|NCT00393042|O4|Outcome|Adderall XR - 25/30 mg|This is the 25/30 mg dosage week for the Adderall XR medication.
363618|NCT00393042|O3|Outcome|Adderall XR - 20 mg|This is the 20 mg dosage week for the Adderall XR medication.
363619|NCT00393042|O2|Outcome|Adderall XR - 10 mg|This is the 10 mg dosage week for the Adderall XR medication.
363620|NCT00393042|O1|Outcome|Adderall XR - Placebo|This is the placebo dosage week for the Adderall XR medication.
363621|NCT00393042|O24|Outcome|10/10 Allele: 25/30mg of Focaling XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
363622|NCT00393042|O23|Outcome|10/10 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
363623|NCT00393042|O22|Outcome|10/10 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
363624|NCT00393042|O21|Outcome|10/10 Allele: Placebo of Focalin XR|This is the Placebo dosage of Focalin XR medication phase for the participants with the 10/10 allele
363627|NCT00393042|O18|Outcome|10/10 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
363628|NCT00393042|O17|Outcome|10/10 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 10/10 allele
363629|NCT00393042|O16|Outcome|9/10 Allele: 25/30 mg of Focalin XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
363630|NCT00393042|O15|Outcome|9/10 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
363631|NCT00393042|O14|Outcome|9/10 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
363632|NCT00393042|O13|Outcome|9/10 Allele: Placebo of Focalin XR|This is the Placebo dosage of Focalin XR medication phase for the participants with the 9/10 allele
363633|NCT00393042|O12|Outcome|9/10 Allele: 25/30 mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
363634|NCT00393042|O11|Outcome|9/10 Allele: 20 mg of Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
363635|NCT00393042|O10|Outcome|9/10 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
363636|NCT00393042|O9|Outcome|9/10 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/10 allele
363637|NCT00393042|O8|Outcome|9/9 Allele: 25/30 mg of Focalin XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
363638|NCT00393042|O7|Outcome|9/9 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
363639|NCT00393042|O6|Outcome|9/9 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
363640|NCT00393042|O5|Outcome|9/9 Allele: Placebo of Focalin XR|This is the placebo dosage of Focalin XR medication phase for the participants with the 9/9 allele
363641|NCT00393042|O4|Outcome|9/9 Allele: 25/30mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
363642|NCT00393042|O3|Outcome|9/9 Allele: 20 mg Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
364896|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
363643|NCT00393042|O2|Outcome|9/9 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
363644|NCT00393042|O1|Outcome|9/9 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/9 allele
363645|NCT00393042|O8|Outcome|Focalin XR - 25/30mg|This is the 25/30 mg dosage week for the Focalin XR medication.
363646|NCT00393042|O7|Outcome|Focalin XR - 20 mg|This is the 20 mg dosage week for the Focalin XR medication.
363647|NCT00393042|O6|Outcome|Focalin XR - 10 mg|This is the 10 mg dosage week for the Focalin XR medication.
363648|NCT00393042|O5|Outcome|Focalin XR - Placebo|This is the placebo dosage week for the Focalin XR medication.
363649|NCT00393042|O4|Outcome|Adderall XR - 25/30mg|This is the 25/30 mg dosage week for the Adderall XR medication.
363650|NCT00393042|O3|Outcome|Adderall XR - 20 mg|This is the 20 mg dosage week for the Adderall XR medication.
363651|NCT00393042|O2|Outcome|Adderall XR - 10 mg|This is the 10 mg dosage week for the Adderall XR medication.
363652|NCT00393042|O1|Outcome|Adderall XR - Placebo|This is the placebo dosage week for the Adderall XR medication.
363653|NCT00393042|O6|Outcome|Focalin XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.
363654|NCT00393042|O5|Outcome|Adderall XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.
363655|NCT00393042|O4|Outcome|25/30mg of Either Focalin XR or Adderall XR|Each participant received 25/30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.
363656|NCT00393042|O3|Outcome|20 mg of Either Focalin XR or Adderall XR|Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.
363657|NCT00393042|O2|Outcome|10mg of Either Focalin XR or Adderall XR|Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.
363658|NCT00393042|O1|Outcome|Placebo|Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.
363659|NCT00393042|O6|Outcome|Focalin XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.
363660|NCT00393042|O5|Outcome|Adderall XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.
363661|NCT00393042|O4|Outcome|25/30mg of Either Focalin XR or Adderall XR|Each participant received 25 or 30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.
363662|NCT00393042|O3|Outcome|20mg of Either Focalin XR or Adderall XR|Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.
363663|NCT00393042|O2|Outcome|10mg of Either Focalin XR or Adderall XR|Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.
363664|NCT00393042|O1|Outcome|Placebo|Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.
363665|NCT00393042|E8|Reported Event|25/30mg of Adderall XR|Each participant recieved 25/30 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
363666|NCT00393042|E7|Reported Event|20 mg of Adderall XR|Each participant recieved 20 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
363667|NCT00393042|E6|Reported Event|10mg of Adderall XR|Each participant recieved 10 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
363668|NCT00393042|E5|Reported Event|Placebo of Adderall XR|Each participant recieved placebo of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
363669|NCT00393042|E4|Reported Event|25/30mg of Focalin XR|Each participant recieved 25/30 mg (depending on weight) of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
363670|NCT00393042|E3|Reported Event|20 mg of Focalin XR|Each participant recieved 20 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
363671|NCT00393042|E2|Reported Event|10mg of Focalin XR|Each participant recieved 10 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
363672|NCT00393042|E1|Reported Event|Placebo of Focalin XR|Each participant recieved placebo of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
363673|NCT00393068|B1|Baseline|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).
Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
363674|NCT00393068|P1|Participant Flow|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).
Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
364897|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
363675|NCT00393068|O1|Outcome|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).
Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
363676|NCT00393068|E1|Reported Event|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).
Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
363677|NCT00393094|B1|Baseline|Enrollment Until Prior to Treatment|
363678|NCT00393094|P1|Participant Flow|Enrollment Until Prior to Treatment|
363679|NCT00393094|O1|Outcome|Bevacizumab & Irinotecan Glioblastoma Multiforme: Enrollment|Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Glioblastoma multiforme- is a fast growing type of central nervous system tumor that forms from glial (supportive) tissue of the brain and spinal cord and has cells that look very different from normal cells. Glioblastoma multiforme usually occurs in adults and affects the brain more often than the spinal cord. Also called GBM, glioblastoma, and grade IV astrocytoma.
363680|NCT00393094|O1|Outcome|Bevacizumab & Irinotecan Anaplastic Glioma Pts: Enrollment|Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Anaplastic gliomas are classified by the World Health Organization (WHO) as grade 3 malignant tumors and include the anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma or mixed glioma.
363681|NCT00393094|O1|Outcome|Enrollment Until Prior to Treatment|
363682|NCT00393094|O1|Outcome|Enrollment Until Prior to Treatment|
363683|NCT00393094|E1|Reported Event|Enrollment Until Prior to Treatment|
363684|NCT00393367|B3|Baseline|Total|Total of all reporting groups
363685|NCT00393367|B2|Baseline|Placebo (Saline)|standardized treatment with nebulized saline
363686|NCT00393367|B1|Baseline|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
363687|NCT00393367|P2|Participant Flow|Placebo (Saline)|standardized treatment with nebulized saline
363688|NCT00393367|P1|Participant Flow|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
363689|NCT00393367|O2|Outcome|Placebo (Saline)|standardized treatment with nebulized saline
363690|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
363691|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
363692|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
363693|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
363694|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
363695|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
363696|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
363697|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
363698|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
363699|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
363701|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
363702|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
363703|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
363704|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
363705|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
363706|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
363707|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
363708|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
363709|NCT00393367|O2|Outcome|Placebo (Saline)|standardized treatment with nebulized saline
363710|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
363711|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
363712|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
363713|NCT00393367|E2|Reported Event|Placebo (Saline)|standardized treatment with nebulized saline
363714|NCT00393367|E1|Reported Event|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
363715|NCT00393380|B1|Baseline|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
363716|NCT00393380|P1|Participant Flow|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
363717|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
363718|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
363719|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
363720|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
363721|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
363722|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
363723|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
363725|NCT00393380|E1|Reported Event|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
363726|NCT00393458|B5|Baseline|Total|Total of all reporting groups
363727|NCT00393458|B4|Baseline|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363728|NCT00393458|B3|Baseline|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363729|NCT00393458|B2|Baseline|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363730|NCT00393458|B1|Baseline|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363731|NCT00393458|P4|Participant Flow|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363732|NCT00393458|P3|Participant Flow|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363764|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363795|NCT00393523|B6|Baseline|Total|Total of all reporting groups
363733|NCT00393458|P2|Participant Flow|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363734|NCT00393458|P1|Participant Flow|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363735|NCT00393458|O4|Outcome|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363736|NCT00393458|O3|Outcome|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
364127|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
363737|NCT00393458|O2|Outcome|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363738|NCT00393458|O1|Outcome|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363739|NCT00393458|O4|Outcome|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363740|NCT00393458|O3|Outcome|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363741|NCT00393458|O2|Outcome|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363742|NCT00393458|O1|Outcome|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363743|NCT00393458|E4|Reported Event|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363861|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363744|NCT00393458|E3|Reported Event|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363745|NCT00393458|E2|Reported Event|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363746|NCT00393458|E1|Reported Event|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
363747|NCT00393484|B3|Baseline|Total|Total of all reporting groups
363748|NCT00393484|B2|Baseline|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
364012|NCT00388453|O1|Outcome|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES"
363749|NCT00393484|B1|Baseline|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363750|NCT00393484|P2|Participant Flow|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363751|NCT00393484|P1|Participant Flow|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363752|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363753|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363754|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363755|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363756|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363757|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363758|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363759|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363760|NCT00393484|O2|Outcome|Lamivudine, 100 mg|Participants received lamivudine, 100 mg, once daily for up to 240 weeks
363761|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363762|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363763|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363794|NCT00393510|E1|Reported Event|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
363765|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363766|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363767|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363768|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363769|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363770|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363771|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
364128|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
363772|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363773|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363774|NCT00393484|O2|Outcome|Lamivudine, 100 mg+ Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363775|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363776|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363777|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363778|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363779|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363780|NCT00393484|E2|Reported Event|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363781|NCT00393484|E1|Reported Event|Entecavir , 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
363782|NCT00393510|B3|Baseline|Total|Total of all reporting groups
363783|NCT00393510|B2|Baseline|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
363784|NCT00393510|B1|Baseline|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
363785|NCT00393510|P2|Participant Flow|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
363786|NCT00393510|P1|Participant Flow|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
363787|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
363788|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
363789|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
363790|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
363791|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
363792|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
363793|NCT00393510|E2|Reported Event|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
363796|NCT00393523|B5|Baseline|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
363797|NCT00393523|B4|Baseline|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
363798|NCT00393523|B3|Baseline|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
363799|NCT00393523|B2|Baseline|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
363800|NCT00393523|B1|Baseline|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
363801|NCT00393523|P5|Participant Flow|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
363880|NCT00393796|B2|Baseline|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
363802|NCT00393523|P4|Participant Flow|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
363803|NCT00393523|P3|Participant Flow|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
363804|NCT00393523|P2|Participant Flow|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
363805|NCT00393523|P1|Participant Flow|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
363806|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
363807|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
363808|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
363809|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
363810|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
363811|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
363812|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
363813|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
363814|NCT00393523|E5|Reported Event|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
363815|NCT00393523|E4|Reported Event|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
363862|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363863|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
364098|NCT00394329|B5|Baseline|Total|Total of all reporting groups
363816|NCT00393523|E3|Reported Event|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
363817|NCT00393523|E2|Reported Event|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
363818|NCT00393523|E1|Reported Event|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
363819|NCT00393705|B3|Baseline|Total|Total of all reporting groups
363820|NCT00393705|B2|Baseline|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363881|NCT00393796|B1|Baseline|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
364157|NCT00394472|O1|Outcome|AZD3355|AZD3355 capsules 65 mg bid
363821|NCT00393705|B1|Baseline|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363822|NCT00393705|P2|Participant Flow|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363823|NCT00393705|P1|Participant Flow|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363824|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363825|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363826|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363827|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363828|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363829|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363830|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363831|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363832|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363864|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363865|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363866|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363867|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363833|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363834|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363835|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363882|NCT00393796|P2|Participant Flow|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
363836|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363837|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363838|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363839|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363840|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363841|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363842|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363843|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363844|NCT00393705|E2|Reported Event|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
363845|NCT00393705|E1|Reported Event|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
363846|NCT00393718|B3|Baseline|Total|Total of all reporting groups
363847|NCT00393718|B2|Baseline|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363848|NCT00393718|B1|Baseline|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363849|NCT00393718|P2|Participant Flow|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363850|NCT00393718|P1|Participant Flow|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363851|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363852|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363853|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363854|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363855|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363856|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363857|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363858|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363859|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363860|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363868|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363869|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363870|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363871|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363872|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363873|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363874|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363875|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363876|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363877|NCT00393718|E2|Reported Event|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
363878|NCT00393718|E1|Reported Event|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
363879|NCT00393796|B3|Baseline|Total|Total of all reporting groups
363883|NCT00393796|P1|Participant Flow|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
363884|NCT00393796|O2|Outcome|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
363885|NCT00393796|O1|Outcome|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
363886|NCT00393796|E2|Reported Event|Placebo Only|"Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
28 participants were randomized to Placebo. 16 of these 28 patients later received SUTENT."
363887|NCT00393796|E1|Reported Event|SUTENT|"Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
26 participants were randomized to SUTENT and 16 participants randomized to Placebo crossed over to SUTENT during treatment so a total of 42 participants were treated with SUTENT."
363888|NCT00393848|B5|Baseline|Total|Total of all reporting groups
363889|NCT00393848|B4|Baseline|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
363890|NCT00393848|B3|Baseline|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
363891|NCT00393848|B2|Baseline|Experiment 1 - Standard of Care|Usual clinical care - no dietary intervention.
363892|NCT00393848|B1|Baseline|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
363893|NCT00393848|P4|Participant Flow|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
363894|NCT00393848|P3|Participant Flow|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
363895|NCT00393848|P2|Participant Flow|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
363896|NCT00393848|P1|Participant Flow|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
363897|NCT00393848|O2|Outcome|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
363898|NCT00393848|O1|Outcome|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
363899|NCT00393848|O4|Outcome|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
363900|NCT00393848|O3|Outcome|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
363901|NCT00393848|O2|Outcome|Experiment 1 - Standard of Care|Usual clinical care without dietary intervention
363902|NCT00393848|O1|Outcome|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
363903|NCT00393848|E4|Reported Event|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
363904|NCT00393848|E3|Reported Event|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
363905|NCT00393848|E2|Reported Event|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
363906|NCT00393848|E1|Reported Event|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement: 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
363907|NCT00393861|B1|Baseline|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
365780|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
363908|NCT00393861|P1|Participant Flow|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
363909|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
363910|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
363911|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
363912|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
363913|NCT00393861|E1|Reported Event|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
363914|NCT00393874|B4|Baseline|Total|Total of all reporting groups
363915|NCT00393874|B3|Baseline|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.
Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
364158|NCT00394472|O2|Outcome|Placebo|Placebo capsules bid
363916|NCT00393874|B2|Baseline|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
363917|NCT00393874|B1|Baseline|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
363918|NCT00393874|P3|Participant Flow|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.
Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
363919|NCT00393874|P2|Participant Flow|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
363920|NCT00393874|P1|Participant Flow|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
363945|NCT00393913|B1|Baseline|Sleep Apnea Assessment|All participants were assigned to a single Arm (and received the intervention based on whether they had sleep apnea). Participants with sleep apnea used the CPAP machine for 4 to 6 weeks every night and then returned to the sleep laboratory for assessment of daytime function. Those without sleep apnea will have the initial assessment but then will not receive the intervention.
363946|NCT00393913|P1|Participant Flow|CPAP|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
363947|NCT00393913|O1|Outcome|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
363948|NCT00393913|O1|Outcome|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
363921|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA take 4 capsules each night, and capsule will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. A placebo pill condition is included for several reasons. First, there is no approved treatment approach currently recognized as being effective for sleep disturbances associated with combat-related PTSD, and which is being withheld from subjects assigned to the placebo arm of the study. We will monitor subjects carefully and on a weekly basis.
Placebo: Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medicat"
363922|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Behavioral Sleep Intervention: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, ni"
364159|NCT00394472|O1|Outcome|AZD3355|AZD3355 capsules 65 mg bid
363923|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.
Prazosin: Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin is 10 mg. Some individuals may require doses up to 15 mg, (Murray Raskind, M.D., personal"
363924|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.
Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
363925|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
363926|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
363927|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.
Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
363928|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
364444|NCT00398216|P4|Participant Flow|Edoxaban 90mg QD|edoxaban 90mg QD PO
363929|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
363930|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.
Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
364013|NCT00388453|O3|Outcome|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
363931|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
363932|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
363933|NCT00393874|E3|Reported Event|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. A placebo pill condition is included for several reasons. First, there is no approved treatment approach currently recognized as being effective for sleep disturbances associated with combat-related PTSD, and which is being withheld from subjects assigned to the placebo arm of the study. We will monitor subjects carefully and on a weekly basis.
Placebo: Participants randomized to PLA took 4 capsules each night for eight weeks, all capsules were identical to prazosin capsules. They received a one-week medication."
363934|NCT00393874|E2|Reported Event|Behavioral|"Participants randomized to BSI received the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment was administered over 8 weeks. The intervention sessions consisted of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session was conducted on Week 5. Thirty-minute face-to-face contacts were scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that had occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).
Behavioral Sleep Intervention: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, ni"
363935|NCT00393874|E1|Reported Event|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.
Prazosin: Participants randomized to PRZ took 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin was 10 mg. Some individuals required doses up to 15 mg."
363936|NCT00393887|B3|Baseline|Total|Total of all reporting groups
363937|NCT00393887|B2|Baseline|Polypropylene Mesh|Synthetic polypropylene mesh
363938|NCT00393887|B1|Baseline|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
363939|NCT00393887|P2|Participant Flow|Polypropylene Mesh|Synthetic polypropylene mesh
363940|NCT00393887|P1|Participant Flow|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
363941|NCT00393887|O2|Outcome|Polypropylene Mesh|Inguinal hernia repair with Polypropylene mesh
363942|NCT00393887|O1|Outcome|Biodesign IHM Graft|Inguinal hernia repair with Biodesign Inguinal Hernia Matrix (IHM)
363943|NCT00393887|E2|Reported Event|Polypropylene Mesh|Synthetic polypropylene mesh
363944|NCT00393887|E1|Reported Event|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
363949|NCT00393913|O1|Outcome|Sleep Apnea|All participants with obstructive sleep apnea (and no other sleep disorder) and subjects without sleep apnea.
363950|NCT00393913|E1|Reported Event|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
363951|NCT00393939|B3|Baseline|Total|Total of all reporting groups
363952|NCT00393939|B2|Baseline|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
363953|NCT00393939|B1|Baseline|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
363954|NCT00393939|P2|Participant Flow|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
363955|NCT00393939|P1|Participant Flow|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
363956|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
364011|NCT00388453|O2|Outcome|Volunteers With History of Gastroesophageal Reflux Disease|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
363957|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
363958|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
363959|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
363960|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
363961|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
363962|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
363963|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
363964|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
363965|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
363966|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
363967|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
363968|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
363969|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
363970|NCT00393939|E2|Reported Event|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
363971|NCT00393939|E1|Reported Event|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
363972|NCT00393978|B3|Baseline|Total|Total of all reporting groups
363973|NCT00393978|B2|Baseline|Quetiapine + Topiramate|"Quetiapine + Topiramate
Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
363974|NCT00393978|B1|Baseline|Quitiapine + Placebo|"Quetiapine + Placebo
quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
363975|NCT00393978|P2|Participant Flow|Quetiapine + Topiramate|"Quetiapine + Topiramate
Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
363976|NCT00393978|P1|Participant Flow|Quitiapine + Placebo|"Quetiapine + Placebo
quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
363977|NCT00393978|O2|Outcome|Quetiapine and Topiramate|"Quetiapine and Topiramate
Quetiapine and Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
363978|NCT00393978|O1|Outcome|Quitiapine and Placebo|"Quetiapine and Placebo
Quetiapine and placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
363979|NCT00393978|O2|Outcome|Quetiapine and Topiramate|"Quetiapine and Topiramate
Quetiapine and Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
363980|NCT00393978|O1|Outcome|Quitiapine and Placebo|"Quetiapine and Placebo
Quetiapine and placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
363981|NCT00393978|E2|Reported Event|Quetiapine + Topiramate|"Quetiapine + Topiramate
Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
363982|NCT00393978|E1|Reported Event|Quitiapine + Placebo|"Quetiapine + Placebo
quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
363983|NCT00394082|B1|Baseline|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
363984|NCT00394082|P1|Participant Flow|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
363985|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
363986|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
363987|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
363988|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
363989|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
363990|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
363991|NCT00394082|E1|Reported Event|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
363992|NCT00394095|B3|Baseline|Total|Total of all reporting groups
363993|NCT00394095|B2|Baseline|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
363994|NCT00394095|B1|Baseline|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
363995|NCT00394095|P2|Participant Flow|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
363996|NCT00394095|P1|Participant Flow|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
363997|NCT00394095|O2|Outcome|Comparator Group: Placebo Group|Group receiving comparable dosage of placebo over 12 weeks.
363998|NCT00394095|O1|Outcome|Experimental Group: Topiramate Group|Change in Body Weight in kilograms over 12 weeks in the Experimental Topiramate sample (N=16) compared to the Placebo group (N=14).
363999|NCT00394095|O2|Outcome|Placebo Group|Group receiving comparable dosage of placebo over 12 weeks.
364000|NCT00394095|O1|Outcome|Experimental Group: Topiramate Group|Change in Body Weight in kilograms over 12 weeks in the Experimental Topiramate sample (N=16) compared to the Placebo group (N=14).
364001|NCT00394095|E2|Reported Event|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
364002|NCT00394095|E1|Reported Event|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
364003|NCT00388453|B4|Baseline|Total|Total of all reporting groups
364004|NCT00388453|B3|Baseline|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing,and hoarseness.
364005|NCT00388453|B2|Baseline|Volunteers With Gastroesophageal Reflux Disaese (GERD)|History of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy
364006|NCT00388453|B1|Baseline|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES"
364044|NCT00394251|P1|Participant Flow|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364045|NCT00394251|O4|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364007|NCT00388453|P3|Participant Flow|Volunteers With Laryngopharangeal Reflux (LPR)|Patients suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing and hoarseness. This group included non-smokers with unremarkable chest radiographs who had undergone extensive testing and exclusion of other common causes for their laryngeal symptoms by the Vanderbilt Allergy, Sinus and Asthma Program (ASAP), and Vanderbilt Voice Center (spirometry, methacholine challenge, sputum eosinophil count, otolaryngology exam, high-resolution computerized tomography scan of the thorax and sinuses and sinus testing).
364008|NCT00388453|P2|Participant Flow|Volunteers With History of Gastroesophageal Reflux Disease|Patients with a history of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of their symptoms with PPI use and if they had erosive esophagitis by Los Angeles classification at endoscopy.
364009|NCT00388453|P1|Participant Flow|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES"
364010|NCT00388453|O3|Outcome|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
364124|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
364014|NCT00388453|O2|Outcome|Volunteers With History of Gastroesophageal Reflux Disease|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
364015|NCT00388453|O1|Outcome|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES"
364016|NCT00388453|O3|Outcome|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
364017|NCT00388453|O2|Outcome|Volunteers With History of Gastroesophageal Reflux Disease|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
364018|NCT00388453|O1|Outcome|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES"
364019|NCT00388453|O3|Outcome|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
364020|NCT00388453|O2|Outcome|Volunteers With History of Gastroesophageal Reflux Disease|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
364021|NCT00388453|O1|Outcome|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES"
364022|NCT00388453|E3|Reported Event|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
364023|NCT00388453|E2|Reported Event|Volunteers With Gastroesphageal Reflux Disease (GERD)|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at time of endoscopy.
364024|NCT00388453|E1|Reported Event|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES"
364025|NCT00394212|B3|Baseline|Total|Total of all reporting groups
364026|NCT00394212|B2|Baseline|Sham Endoscopy|Sham Endoscopy (suturing not performed)
364027|NCT00394212|B1|Baseline|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
364028|NCT00394212|P2|Participant Flow|Sham Endoscopy|Sham Endoscopy (suturing not performed)
364029|NCT00394212|P1|Participant Flow|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
364030|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
364031|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
364032|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
364033|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
364034|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
364035|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
364036|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
364037|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
364038|NCT00394212|E2|Reported Event|Sham Endoscopy|Sham Endoscopy (suturing not performed)
364039|NCT00394212|E1|Reported Event|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
364040|NCT00394251|B3|Baseline|Total|Total of all reporting groups
364041|NCT00394251|B2|Baseline|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364042|NCT00394251|B1|Baseline|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364043|NCT00394251|P2|Participant Flow|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364046|NCT00394251|O3|Outcome|Taxol Subset|175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
364047|NCT00394251|O2|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364048|NCT00394251|O1|Outcome|ABI-007 Subset|260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
364049|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364050|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364051|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364052|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364053|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364054|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364125|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
364055|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364056|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364057|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364058|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364059|NCT00394251|O4|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364060|NCT00394251|O3|Outcome|Taxol Subset|175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
364061|NCT00394251|O2|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364062|NCT00394251|O1|Outcome|ABI-007 Subset|260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
364063|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364064|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364065|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364066|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364067|NCT00394251|E2|Reported Event|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364068|NCT00394251|E1|Reported Event|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
364069|NCT00394277|B5|Baseline|Total|Total of all reporting groups
364070|NCT00394277|B4|Baseline|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364071|NCT00394277|B3|Baseline|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364072|NCT00394277|B2|Baseline|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364073|NCT00394277|B1|Baseline|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364074|NCT00394277|P4|Participant Flow|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364075|NCT00394277|P3|Participant Flow|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364097|NCT00394277|E1|Reported Event|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364076|NCT00394277|P2|Participant Flow|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364077|NCT00394277|P1|Participant Flow|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364078|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364079|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364080|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364126|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
364081|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364082|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364083|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364084|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364085|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364086|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364087|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364088|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364089|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364090|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364091|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364092|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364093|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364094|NCT00394277|E4|Reported Event|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364095|NCT00394277|E3|Reported Event|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
364096|NCT00394277|E2|Reported Event|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
364099|NCT00394329|B4|Baseline|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
364100|NCT00394329|B3|Baseline|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
364101|NCT00394329|B2|Baseline|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
364102|NCT00394329|B1|Baseline|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
364103|NCT00394329|P4|Participant Flow|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
364104|NCT00394329|P3|Participant Flow|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
364105|NCT00394329|P2|Participant Flow|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
364106|NCT00394329|P1|Participant Flow|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
364107|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
364108|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
364109|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
364110|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
364111|NCT00394329|E4|Reported Event|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
364112|NCT00394329|E3|Reported Event|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
364113|NCT00394329|E2|Reported Event|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
364191|NCT00397514|E1|Reported Event|Pacing Protocol and RV Pacing|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
364192|NCT00397540|B3|Baseline|Total|Total of all reporting groups
364193|NCT00397540|B2|Baseline|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
364114|NCT00394329|E1|Reported Event|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
364115|NCT00394355|B5|Baseline|Total|Total of all reporting groups
364116|NCT00394355|B4|Baseline|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
364117|NCT00394355|B3|Baseline|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
364118|NCT00394355|B2|Baseline|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
364119|NCT00394355|B1|Baseline|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
364120|NCT00394355|P4|Participant Flow|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
364121|NCT00394355|P3|Participant Flow|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
364122|NCT00394355|P2|Participant Flow|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
364123|NCT00394355|P1|Participant Flow|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
364129|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
364130|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
364131|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
364132|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
364133|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
364134|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
364135|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
364136|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
364137|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
364138|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
364139|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
364140|NCT00394355|E4|Reported Event|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
364141|NCT00394355|E3|Reported Event|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
364142|NCT00394355|E2|Reported Event|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
364143|NCT00394355|E1|Reported Event|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
364144|NCT00394433|B1|Baseline|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
364145|NCT00394433|P1|Participant Flow|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
364146|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
364147|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
364194|NCT00397540|B1|Baseline|PEIT|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
364148|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
364149|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
364150|NCT00394433|E1|Reported Event|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
364151|NCT00394472|B3|Baseline|Total|Total of all reporting groups
364152|NCT00394472|B2|Baseline|Placebo|Placebo capsules bid
364153|NCT00394472|B1|Baseline|AZD3355|AZD3355 capsules 65 mg bid
364154|NCT00394472|P2|Participant Flow|Placebo|Placebo capsules bid
364155|NCT00394472|P1|Participant Flow|AZD3355|AZD3355 capsules 65 mg bid
364156|NCT00394472|O2|Outcome|Placebo|Placebo capsules bid
364164|NCT00397462|B2|Baseline|Group 2 High Use|requested that they use the intervention as much as possible during the work day
364165|NCT00397462|B1|Baseline|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
364166|NCT00397462|P3|Participant Flow|Control|No intervention
364167|NCT00397462|P2|Participant Flow|Group 2 High Use|requested that they use the intervention as much as possible during the work day
364168|NCT00397462|P1|Participant Flow|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
364169|NCT00397462|O3|Outcome|High Dose|"Request that calf muscle pump stimulation be used at least four hours per day
calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
364170|NCT00397462|O2|Outcome|Low Dose|"Request that calf muscle pump stimulation be used less than four hours per day
calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
364171|NCT00397462|O1|Outcome|Control|No change to usual behavior
364172|NCT00397462|O3|Outcome|High Dose|"Request that calf muscle pump stimulation be used at least four hours per day
calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
364173|NCT00397462|O2|Outcome|Low Dose|"Request that calf muscle pump stimulation be used less than four hours per day
calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
364174|NCT00397462|O1|Outcome|Control|No change to usual behavior
364175|NCT00397462|E3|Reported Event|Control|did not use the intervention
364176|NCT00397462|E2|Reported Event|Group 2 High Use|requested that they use the intervention as much as possible during the work day
364177|NCT00397462|E1|Reported Event|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
364178|NCT00397488|B1|Baseline|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
364179|NCT00397488|P1|Participant Flow|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
364180|NCT00397488|O1|Outcome|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
364181|NCT00397488|E1|Reported Event|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
364182|NCT00397514|B1|Baseline|Congenital Heart Disease Patients|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
364183|NCT00397514|P1|Participant Flow|Congenital Heart Disease Pts. Undergoing Biventricular Repair|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
364184|NCT00397514|O1|Outcome|Congenital Heart Disease Pts. Undergoing Biventricular Repair|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
364185|NCT00397514|O3|Outcome|RV Pacing|QRS duration when patient's extubation with 20 min. of right ventricular pacing
364186|NCT00397514|O2|Outcome|BiV Pacing|QRS duration when patient's extubation with 20 min. of biventricular pacing
364187|NCT00397514|O1|Outcome|Baseline|QRS duration at baseline
364188|NCT00397514|O3|Outcome|RV Pacing|Cardiac Index when patient's extubation with 20 min. of right ventricular pacing
364189|NCT00397514|O2|Outcome|BiV Pacing|Cardiac Index when patient's extubation with 20 min. of biventricular pacing
364190|NCT00397514|O1|Outcome|Baseline|Cardiac Index at baseline.
364195|NCT00397540|P2|Participant Flow|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
364196|NCT00397540|P1|Participant Flow|Percutaneous Ethanol Injection Therapy|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
364197|NCT00397540|O2|Outcome|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
364198|NCT00397540|O1|Outcome|PEIT|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
364199|NCT00397540|E2|Reported Event|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
364200|NCT00397540|E1|Reported Event|Percutaneous Ethanol Injection Therapy|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
364201|NCT00397631|B3|Baseline|Total|Total of all reporting groups
364202|NCT00397631|B2|Baseline|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
364203|NCT00397631|B1|Baseline|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
364204|NCT00397631|P2|Participant Flow|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
364205|NCT00397631|P1|Participant Flow|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
364248|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364898|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
364206|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
364207|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
364208|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
364209|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
364210|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
364211|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
364212|NCT00397631|E2|Reported Event|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
364213|NCT00397631|E1|Reported Event|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
364214|NCT00397839|B3|Baseline|Total|Total of all reporting groups
364215|NCT00397839|B2|Baseline|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
364216|NCT00397839|B1|Baseline|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
364217|NCT00397839|P2|Participant Flow|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
364218|NCT00397839|P1|Participant Flow|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
364219|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
364220|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
364221|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
364222|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
364223|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
364224|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
364225|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
364226|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
364227|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
364228|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
364229|NCT00397839|E2|Reported Event|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
364230|NCT00397839|E1|Reported Event|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
364231|NCT00397878|B1|Baseline|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364232|NCT00397878|P1|Participant Flow|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364233|NCT00397878|O1|Outcome|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364234|NCT00397878|E1|Reported Event|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364235|NCT00397891|B6|Baseline|Total|Total of all reporting groups
364236|NCT00397891|B5|Baseline|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364237|NCT00397891|B4|Baseline|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364238|NCT00397891|B3|Baseline|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364239|NCT00397891|B2|Baseline|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364240|NCT00397891|B1|Baseline|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364241|NCT00397891|P5|Participant Flow|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364242|NCT00397891|P4|Participant Flow|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364243|NCT00397891|P3|Participant Flow|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364244|NCT00397891|P2|Participant Flow|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364245|NCT00397891|P1|Participant Flow|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364246|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364247|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364249|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364250|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364251|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364252|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364253|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364254|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364255|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364256|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364257|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364258|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364259|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364260|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364261|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364262|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364263|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364264|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364265|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364266|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364267|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364268|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364269|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364270|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364271|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364272|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364273|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364274|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364275|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364276|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364497|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
364277|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364278|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364279|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364280|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364281|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364282|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364283|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364284|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364285|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364286|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364287|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364288|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364289|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364290|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364291|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364292|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364293|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364294|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364295|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364296|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364297|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364298|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364299|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364300|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364301|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364302|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364303|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364304|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364305|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364306|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364307|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364308|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364309|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364310|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364311|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364312|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364313|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364314|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364315|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364316|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364317|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364318|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364319|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364320|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364321|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364322|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364323|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364324|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364325|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364326|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364327|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364328|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364329|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364330|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364331|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364332|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364333|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364334|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364335|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364336|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364337|NCT00397891|E5|Reported Event|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
364338|NCT00397891|E4|Reported Event|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
364339|NCT00397891|E3|Reported Event|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
364340|NCT00397891|E2|Reported Event|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
364341|NCT00397891|E1|Reported Event|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
364359|NCT00397982|O1|Outcome|Entire Study|17 participants
364360|NCT00397982|O1|Outcome|Entire Study|17 participants
364361|NCT00397982|O1|Outcome|Entire Study|17 participants
364362|NCT00397982|O1|Outcome|Entire Study|Treatment
364342|NCT00397904|B1|Baseline|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
364343|NCT00397904|P1|Participant Flow|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
364344|NCT00397904|O1|Outcome|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
364345|NCT00397904|E1|Reported Event|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
364346|NCT00397930|B3|Baseline|Total|Total of all reporting groups
364347|NCT00397930|B2|Baseline|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
fatigue assessment and management
management of therapy complications
quality-of-life assessment"
364348|NCT00397930|B1|Baseline|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
sleep disorder therapy
yoga therapy"
364349|NCT00397930|P2|Participant Flow|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
fatigue assessment and management
management of therapy complications
quality-of-life assessment"
364350|NCT00397930|P1|Participant Flow|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
sleep disorder therapy
yoga therapy"
364351|NCT00397930|O2|Outcome|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
fatigue assessment and management
management of therapy complications
quality-of-life assessment"
364352|NCT00397930|O1|Outcome|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
sleep disorder therapy
yoga therapy"
364353|NCT00397930|E2|Reported Event|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
fatigue assessment and management
management of therapy complications
quality-of-life assessment"
364354|NCT00397930|E1|Reported Event|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
sleep disorder therapy
yoga therapy"
364355|NCT00397982|B1|Baseline|Entire Study|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV
Therapeutic Conventional Surgery: Undergo tumor resection"
364356|NCT00397982|P1|Participant Flow|Treatment (Enzyme Inhibitor, Monoclonal Antibody)|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV
Therapeutic Conventional Surgery: Undergo tumor resection"
364357|NCT00397982|O1|Outcome|Entire Study|17 participants
364358|NCT00397982|O1|Outcome|Entire Study|17 participants
364363|NCT00397982|E1|Reported Event|Entire Study|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV
Therapeutic Conventional Surgery: Undergo tumor resection"
364364|NCT00398047|B1|Baseline|Azacitidine and Darbopoietin and G-CSF|
364365|NCT00398047|P1|Participant Flow|Combination of Azacitadine and Hematopoietic Growth Factors|azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is >=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
364366|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
364367|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
364368|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
364369|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
364370|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
364371|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is >=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
364372|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
364373|NCT00398047|E1|Reported Event|Azacitidine and Darbopoietin and G-CSF|
364374|NCT00398073|B3|Baseline|Total|Total of all reporting groups
364375|NCT00398073|B2|Baseline|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine"
364376|NCT00398073|B1|Baseline|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine"
364377|NCT00398073|P2|Participant Flow|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine"
364378|NCT00398073|P1|Participant Flow|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine"
364379|NCT00398073|O2|Outcome|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine"
364380|NCT00398073|O1|Outcome|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine"
364381|NCT00398073|O2|Outcome|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine"
364382|NCT00398073|O1|Outcome|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine"
364383|NCT00398073|O2|Outcome|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine"
364384|NCT00398073|O1|Outcome|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine"
364464|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
364465|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
364385|NCT00398073|E2|Reported Event|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
mouse gp100 plasmid DNA vaccine"
364386|NCT00398073|E1|Reported Event|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
mouse gp100 plasmid DNA vaccine"
364387|NCT00398086|B4|Baseline|Total|Total of all reporting groups
364388|NCT00398086|B3|Baseline|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364389|NCT00398086|B2|Baseline|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364390|NCT00398086|B1|Baseline|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364391|NCT00398086|P3|Participant Flow|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364392|NCT00398086|P2|Participant Flow|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364393|NCT00398086|P1|Participant Flow|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364394|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364395|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364396|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364397|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364398|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364399|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364400|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364401|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364402|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364403|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364404|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364405|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364406|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364407|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364408|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364466|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
364899|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
364409|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364410|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364411|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364412|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364413|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364414|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364415|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364416|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364417|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364418|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364419|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364420|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364421|NCT00398086|E3|Reported Event|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
364422|NCT00398086|E2|Reported Event|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
364423|NCT00398086|E1|Reported Event|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
364443|NCT00398216|P5|Participant Flow|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
364424|NCT00398112|B1|Baseline|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
364425|NCT00398112|P1|Participant Flow|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
364426|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
364427|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
364428|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
364429|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
364430|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
364431|NCT00398112|E1|Reported Event|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
364467|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
364468|NCT00398216|E5|Reported Event|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
364469|NCT00398216|E4|Reported Event|Edoxaban 90mg QD|edoxaban 90mg QD PO
364470|NCT00398216|E3|Reported Event|Edoxaban 60mg QD|edoxaban 60mg QD PO
364471|NCT00398216|E2|Reported Event|Edoxaban 30mg QD|edoxaban 30mg QD PO
364472|NCT00398216|E1|Reported Event|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
364678|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364432|NCT00398138|B1|Baseline|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.
WT-1 analog peptide vaccine"
364433|NCT00398138|P1|Participant Flow|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.
WT-1 analog peptide vaccine"
364434|NCT00398138|O1|Outcome|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.
WT-1 analog peptide vaccine"
364435|NCT00398138|O1|Outcome|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.
WT-1 analog peptide vaccine"
364436|NCT00398138|E1|Reported Event|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.
WT-1 analog peptide vaccine"
364437|NCT00398216|B6|Baseline|Total|Total of all reporting groups
364438|NCT00398216|B5|Baseline|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
364439|NCT00398216|B4|Baseline|Edoxaban 90mg QD|edoxaban 90mg QD PO
364440|NCT00398216|B3|Baseline|Edoxaban 60mg QD|edoxaban 60mg QD PO
364441|NCT00398216|B2|Baseline|Edoxaban 30mg QD|edoxaban 30mg QD PO
364442|NCT00398216|B1|Baseline|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
364537|NCT00398983|O2|Outcome|No Study Drug|Continue current therapy.
364445|NCT00398216|P3|Participant Flow|Edoxaban 60mg QD|edoxaban 60mg QD PO
364446|NCT00398216|P2|Participant Flow|Edoxaban 30mg QD|edoxaban 30mg QD PO
364447|NCT00398216|P1|Participant Flow|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
364448|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
364449|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
364450|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
364451|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
364452|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
364453|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
364454|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
364455|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
364456|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
364457|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
364458|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
364459|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
364460|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
364461|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
364462|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
364463|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
364473|NCT00398320|B1|Baseline|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle
Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle
Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle
AEs reported are related and grade 3 or higher per CTCAE version 3."
364474|NCT00398320|P1|Participant Flow|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle
Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle
Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle
Adverse events (AEs) reported are related and grade 3 or higher per CTCAE version 3."
364475|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle
Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle
Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle
AEs reported are related and grade 3 or higher per CTCAE version 3."
364476|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle
Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle
Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle
AEs reported are related and grade 3 or higher per CTCAE version 3."
364477|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle
Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle
Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle
AEs reported are related and grade 3 or higher per CTCAE version 3."
364478|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle
Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle
Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle
AEs reported are related and grade 3 or higher per CTCAE version 3."
364479|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle
Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle
Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle
AEs reported are related and grade 3 or higher per CTCAE version 3."
364480|NCT00398320|E1|Reported Event|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle
Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle
Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle
AEs reported are related and grade 3 or higher per CTCAE version 3."
364481|NCT00398398|B1|Baseline|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
364482|NCT00398398|P1|Participant Flow|Xelox Plus Cetuximab|"Capecitabine, oxaliplatin and cetuximab
cetuximab : initial loading dose of 400 mg/m2, maintenance dose of 250 mg/m2 (every week) Oxaliplatin : 130 mg/m2 (every 3 weeks) capecitabine :1,000 mg/m2 (days 1–14)"
364483|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
364484|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
364485|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
364486|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
364487|NCT00398398|E1|Reported Event|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
364488|NCT00398411|B3|Baseline|Total|Total of all reporting groups
364489|NCT00398411|B2|Baseline|Placebo|identical appearing placebo
364490|NCT00398411|B1|Baseline|Moxifloxacin|moxifloxacin 400 mg tablets once daily
364491|NCT00398411|P2|Participant Flow|Placebo|identical appearing placebo
364492|NCT00398411|P1|Participant Flow|Moxifloxacin|moxifloxacin 400 mg tablets once daily
364493|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
364494|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
364495|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
364496|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
364498|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
364499|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
364500|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
364501|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
364502|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
364503|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
364504|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
364505|NCT00398411|E2|Reported Event|Placebo|identical appearing placebo
364506|NCT00398411|E1|Reported Event|Moxifloxacin|moxifloxacin 400 mg tablets once daily
364507|NCT00398632|B1|Baseline|Duloxetine|Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. study duration: 12 weeks
364508|NCT00398632|P1|Participant Flow|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)
Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
364509|NCT00398632|O1|Outcome|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)
Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
364510|NCT00398632|E1|Reported Event|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)
Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
364511|NCT00398866|B4|Baseline|Total|Total of all reporting groups
364512|NCT00398866|B3|Baseline|Hylan G-F 20|"Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
364513|NCT00398866|B2|Baseline|Triamcinolone|"Corticosteroid (trimcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
364672|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364514|NCT00398866|B1|Baseline|Bupivicaine|"Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
364515|NCT00398866|P3|Participant Flow|Hylan G-F 20|"Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
364516|NCT00398866|P2|Participant Flow|Triamcinolone|"Corticosteroid (triamcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
364517|NCT00398866|P1|Participant Flow|Bupivicaine|"Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
364518|NCT00398866|O3|Outcome|Hylan G-F 20|"Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
364519|NCT00398866|O2|Outcome|Triamcinolone|"Corticosteroid (triamcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
364520|NCT00398866|O1|Outcome|Bupivicaine|"Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
364521|NCT00398866|O3|Outcome|Hylan G-F 20|"Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
364522|NCT00398866|O2|Outcome|Triamcinolone|"Corticosteroid (trimcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
364523|NCT00398866|O1|Outcome|Bupivicaine|"Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
364524|NCT00398866|E3|Reported Event|Hylan G-F 20|"Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
364525|NCT00398866|E2|Reported Event|Triamcinolone|"Corticosteroid (triamcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
364526|NCT00398866|E1|Reported Event|Bupivicaine|"Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
364527|NCT00398918|B1|Baseline|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
364528|NCT00398918|P1|Participant Flow|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
364529|NCT00398918|O1|Outcome|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
364530|NCT00398918|O1|Outcome|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
364531|NCT00398918|E1|Reported Event|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
364532|NCT00398983|B3|Baseline|Total|Total of all reporting groups
364533|NCT00398983|B2|Baseline|No Study Drug|Continue current therapy.
364534|NCT00398983|B1|Baseline|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
364535|NCT00398983|P2|Participant Flow|No Study Drug|Continue current therapy.
364536|NCT00398983|P1|Participant Flow|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
364538|NCT00398983|O1|Outcome|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
364539|NCT00398983|E2|Reported Event|No Study Drug|Continue current therapy.
364540|NCT00398983|E1|Reported Event|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
364541|NCT00399035|B4|Baseline|Total|Total of all reporting groups
364542|NCT00399035|B3|Baseline|Cediranib 30 mg|Cediranib 30 mg/day + FOLFOX/XELOX
364543|NCT00399035|B2|Baseline|Placebo|Placebo + FOLFOX/XELOX
364544|NCT00399035|B1|Baseline|Cediranib 20 mg|Cediranib 20 mg + FOLFOX/XELOX
364545|NCT00399035|P3|Participant Flow|Placebo|[Placebo +FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
364546|NCT00399035|P2|Participant Flow|Cediranib 30 mg/Day|[Cediranib 30mg/day+FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
364673|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364547|NCT00399035|P1|Participant Flow|Cediranib 20 mg/Day|[Cediranib 20mg/day+FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
364548|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
364549|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
364550|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
364551|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
364552|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
364553|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
364554|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
364555|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
364556|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
364557|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
364558|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
364559|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
364560|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
364561|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
364562|NCT00399035|E3|Reported Event|Placebo|Placebo + Folfox/Xelox
364563|NCT00399035|E2|Reported Event|Cediranib 20mg|Cediranib 20mg/day + Folfox/Xelox
364564|NCT00399035|E1|Reported Event|Cediranib 30mg|Cediranib 30mg/day + Folfox/Xelox
364565|NCT00399308|B4|Baseline|Total|Total of all reporting groups
364566|NCT00399308|B3|Baseline|Group III - Control|Adaptic and Profore four-layer compression dressing
364567|NCT00399308|B2|Baseline|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364568|NCT00399308|B1|Baseline|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364569|NCT00399308|P3|Participant Flow|Group III - Control|Adaptic and Profore four-layer compression dressing
364570|NCT00399308|P2|Participant Flow|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364571|NCT00399308|P1|Participant Flow|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364572|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
364573|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364574|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364575|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
364576|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364577|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364578|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
364579|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364580|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364581|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
364582|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364583|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364584|NCT00399308|E3|Reported Event|Group III - Control|Adaptic and Profore four-layer compression dressing
364585|NCT00399308|E2|Reported Event|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364586|NCT00399308|E1|Reported Event|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
364587|NCT00399360|B5|Baseline|Total|Total of all reporting groups
364588|NCT00399360|B4|Baseline|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364589|NCT00399360|B3|Baseline|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364590|NCT00399360|B2|Baseline|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364591|NCT00399360|B1|Baseline|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364592|NCT00399360|P4|Participant Flow|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364593|NCT00399360|P3|Participant Flow|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364594|NCT00399360|P2|Participant Flow|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364595|NCT00399360|P1|Participant Flow|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364596|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
364597|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
364598|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
364599|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
364600|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364601|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364602|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364603|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364604|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
364605|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
364606|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
364607|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
364608|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
364609|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
364610|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
364643|NCT00399516|E1|Reported Event|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) Treatment Group
364644|NCT00399542|B3|Baseline|Total|Total of all reporting groups
364611|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
364612|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
364613|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
364614|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
364615|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|
364616|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
364617|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
364618|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
364619|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
364620|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
364621|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
364622|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
364623|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
364624|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364625|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364674|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364675|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364626|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364627|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364628|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364629|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364630|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364631|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364632|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364633|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364634|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364635|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364636|NCT00399360|E4|Reported Event|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364637|NCT00399360|E3|Reported Event|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364638|NCT00399360|E2|Reported Event|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364639|NCT00399360|E1|Reported Event|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
364640|NCT00399516|B1|Baseline|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) Treatment Group
364641|NCT00399516|P1|Participant Flow|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
364642|NCT00399516|O1|Outcome|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
364645|NCT00399542|B2|Baseline|Placebo|Subjects who received placebo
364646|NCT00399542|B1|Baseline|Lubiprostone|Subjects who received active drug
364647|NCT00399542|P2|Participant Flow|Placebo|Subjects who received placebo
364648|NCT00399542|P1|Participant Flow|Lubiprostone|Subjects who received active drug
364649|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364650|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364651|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364652|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364653|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364654|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364655|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364656|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364657|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364658|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364659|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364660|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364661|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364662|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364663|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364664|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364665|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364666|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364667|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364668|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364669|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364670|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364671|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364680|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364681|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364682|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364683|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364684|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364685|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364686|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364687|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364688|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364689|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364690|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364691|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364692|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364693|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364694|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364695|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364696|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364697|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364698|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364699|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364700|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364701|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364702|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364703|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364704|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364705|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
364706|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
364707|NCT00399542|E2|Reported Event|Placebo|Subjects who received placebo
364708|NCT00399542|E1|Reported Event|Lubiprostone|Subjects who received active drug
364709|NCT00399568|B3|Baseline|Total|Total of all reporting groups
364710|NCT00399568|B2|Baseline|IV Placebo 100 mL Solution|All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
364711|NCT00399568|B1|Baseline|IV Acetaminophen 1 g/100 mL Solution|All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
364712|NCT00399568|P2|Participant Flow|IV Placebo 100 mL Solution|All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
364713|NCT00399568|P1|Participant Flow|IV Acetaminophen 1 g/100 mL Solution|All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
364714|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
364715|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
364716|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
364717|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
364718|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|Safety Population(defined as those subjects who received any portion of a dose of IV Placebo 100 ml solution)
364719|NCT00399568|O1|Outcome|IV Acetaminophen 1g/100 ml Solution|Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 ml solution)
364720|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
364721|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
364722|NCT00399568|E2|Reported Event|IV Placebo 100 mL Solution|Safety Population (defined as those subjects who received any portion of a dose of IV Placebo 100 mL solution)
364723|NCT00399568|E1|Reported Event|IV Acetaminophen 1g/100 mL Solution|Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 mL solution)
364724|NCT00399763|B3|Baseline|Total|Total of all reporting groups
364725|NCT00399763|B2|Baseline|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
364726|NCT00399763|B1|Baseline|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
364727|NCT00399763|P2|Participant Flow|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
364728|NCT00399763|P1|Participant Flow|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
364729|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
364730|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
364731|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
364732|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
364733|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
364734|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
364735|NCT00399763|E2|Reported Event|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
364736|NCT00399763|E1|Reported Event|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
364737|NCT00399893|B3|Baseline|Total|Total of all reporting groups
364738|NCT00399893|B2|Baseline|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364739|NCT00399893|B1|Baseline|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364740|NCT00399893|P2|Participant Flow|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364741|NCT00399893|P1|Participant Flow|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364742|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364743|NCT00399893|O1|Outcome|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364744|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364745|NCT00399893|O1|Outcome|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364746|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364747|NCT00399893|O1|Outcome|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364748|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364749|NCT00399893|O1|Outcome|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364750|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364751|NCT00399893|O1|Outcome|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364752|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364753|NCT00399893|O1|Outcome|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364754|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364755|NCT00399893|O1|Outcome|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364756|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364757|NCT00399893|O1|Outcome|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364758|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364759|NCT00399893|O1|Outcome|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364760|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364761|NCT00399893|O1|Outcome|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364762|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364763|NCT00399893|O1|Outcome|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364764|NCT00399893|E2|Reported Event|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
364765|NCT00399893|E1|Reported Event|Octreotide|"Octreotide :
Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
364766|NCT00391365|B3|Baseline|Total|Total of all reporting groups
364767|NCT00391365|B2|Baseline|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
364768|NCT00391365|B1|Baseline|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
364769|NCT00391365|P2|Participant Flow|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
364770|NCT00391365|P1|Participant Flow|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
364771|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis.
364772|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
364773|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis.
364774|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
364775|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
364776|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
364777|NCT00391365|E2|Reported Event|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
364778|NCT00391365|E1|Reported Event|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
364779|NCT00391391|B5|Baseline|Total|Total of all reporting groups
364780|NCT00391391|B4|Baseline|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
364781|NCT00391391|B3|Baseline|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
364782|NCT00391391|B2|Baseline|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
364783|NCT00391391|B1|Baseline|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
364784|NCT00391391|P4|Participant Flow|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
364785|NCT00391391|P3|Participant Flow|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
364786|NCT00391391|P2|Participant Flow|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
364787|NCT00391391|P1|Participant Flow|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
364788|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
364789|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
364790|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
365781|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
364791|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
364792|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
364793|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
364794|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
364795|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
364796|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
364797|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
364798|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
364799|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
364800|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
364801|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
364802|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
364803|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
364804|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
364805|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
364806|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
364807|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
364808|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
364809|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
364900|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
364810|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
364811|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
364812|NCT00391391|E4|Reported Event|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
364813|NCT00391391|E3|Reported Event|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
364814|NCT00391391|E2|Reported Event|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
364815|NCT00391391|E1|Reported Event|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
364816|NCT00391443|B3|Baseline|Total|Total of all reporting groups
364817|NCT00391443|B2|Baseline|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
364818|NCT00391443|B1|Baseline|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
364819|NCT00391443|P2|Participant Flow|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
364820|NCT00391443|P1|Participant Flow|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
364821|NCT00391443|O2|Outcome|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
364822|NCT00391443|O1|Outcome|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
364823|NCT00391443|O2|Outcome|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
364824|NCT00391443|O1|Outcome|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
364825|NCT00391443|E2|Reported Event|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
364826|NCT00391443|E1|Reported Event|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
364827|NCT00391469|B5|Baseline|Total|Total of all reporting groups
364828|NCT00391469|B4|Baseline|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
Rapid infusion of cold normal saline"
364829|NCT00391469|B3|Baseline|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
364830|NCT00391469|B2|Baseline|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
Rapid infusion of cold normal saline"
364831|NCT00391469|B1|Baseline|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
364832|NCT00391469|P2|Participant Flow|Control|standard of care
364833|NCT00391469|P1|Participant Flow|Intervention|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
Rapid infusion of cold normal saline"
364834|NCT00391469|O4|Outcome|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
Rapid infusion of cold normal saline"
364835|NCT00391469|O3|Outcome|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
364836|NCT00391469|O2|Outcome|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
Rapid infusion of cold normal saline"
364837|NCT00391469|O1|Outcome|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
364838|NCT00391469|O4|Outcome|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
Rapid infusion of cold normal saline"
364839|NCT00391469|O3|Outcome|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
364840|NCT00391469|O2|Outcome|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
Rapid infusion of cold normal saline"
364841|NCT00391469|O1|Outcome|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
364842|NCT00391469|E2|Reported Event|Control-standard Care|standard care
364843|NCT00391469|E1|Reported Event|Intervention-hypo|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
Rapid infusion of cold normal saline"
364844|NCT00391586|B1|Baseline|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
364845|NCT00391586|P1|Participant Flow|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
364846|NCT00391586|O1|Outcome|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
364847|NCT00391586|O1|Outcome|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
364848|NCT00391586|E1|Reported Event|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
364849|NCT00391599|B3|Baseline|Total|Total of all reporting groups
364850|NCT00391599|B2|Baseline|Control Group|no preoperative intestinal preparation.
364851|NCT00391599|B1|Baseline|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section
enema"
364852|NCT00391599|P2|Participant Flow|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
364853|NCT00391599|P1|Participant Flow|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
364854|NCT00391599|O2|Outcome|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
364855|NCT00391599|O1|Outcome|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
364856|NCT00391599|O2|Outcome|Control Group|"no preoperative intestinal preparation.
enema"
364857|NCT00391599|O1|Outcome|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section
enema"
364858|NCT00391599|O2|Outcome|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
364859|NCT00391599|O1|Outcome|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
364860|NCT00391599|E2|Reported Event|Control Group|"no preoperative intestinal preparation.
the night before cesarean section"
364861|NCT00391599|E1|Reported Event|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section
enema
the night before cesarean section"
364862|NCT00400153|B4|Baseline|Total|Total of all reporting groups
364863|NCT00400153|B3|Baseline|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364864|NCT00400153|B2|Baseline|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364865|NCT00400153|B1|Baseline|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364866|NCT00400153|P3|Participant Flow|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364867|NCT00400153|P2|Participant Flow|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364868|NCT00400153|P1|Participant Flow|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364869|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364870|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364871|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364872|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364873|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364874|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364875|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364876|NCT00400153|O3|Outcome|Ipratropium Respimat 20 Mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364877|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364878|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364879|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364880|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364881|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364882|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364883|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364884|NCT00400153|O1|Outcome|Number of Patients|Total number of patients due to rating of turning
364885|NCT00400153|O1|Outcome|Number of Patients|Total number of patients due to device preference
364886|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
364901|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
364902|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
364903|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
364904|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
364905|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
364906|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
364907|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
364908|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364909|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364910|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364911|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364912|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364913|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364914|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364915|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364916|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364917|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364918|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364919|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364920|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364921|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364922|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364923|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364924|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364925|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364926|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365782|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
364927|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364928|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364929|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364930|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364931|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364932|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364933|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364934|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364935|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364936|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364937|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364938|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364939|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364940|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364941|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364942|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364943|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364944|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364945|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364946|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364947|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364948|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364949|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364950|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364951|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364952|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364953|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364954|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364955|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364956|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364957|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364958|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364959|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364960|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364961|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364962|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364963|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364964|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364965|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364966|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364967|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364968|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364969|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364970|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364971|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364972|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364973|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364974|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364975|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364976|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364977|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364978|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364979|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364980|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364981|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364982|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364983|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364984|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364985|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364986|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364987|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364988|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364989|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364990|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364991|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364992|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364993|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364994|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364995|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364996|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
364997|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
364998|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
364999|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365000|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365001|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365002|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365003|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365004|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365005|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365006|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365007|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365008|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365009|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365010|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365011|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365012|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365013|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365014|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365015|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365016|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365017|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365018|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365019|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365020|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365021|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365022|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365023|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365024|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365025|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365026|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365027|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365028|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365029|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365030|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365031|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365032|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365033|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365034|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365035|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365036|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365037|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365038|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365039|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365040|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365041|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365042|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365043|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365044|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365045|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365046|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365047|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365048|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365049|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365050|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365051|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365052|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365053|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365054|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365055|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365056|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365057|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365058|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365059|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365060|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365061|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365062|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365063|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365064|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365065|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365066|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365067|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365068|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365069|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365070|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365071|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365072|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365073|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365074|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365075|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365076|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365077|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365078|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365079|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365080|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365081|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365082|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365083|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365084|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365085|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365086|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365087|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365088|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365089|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365090|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365091|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365092|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365093|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365094|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365095|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365096|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365097|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365098|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365099|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365100|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365101|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365102|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365103|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365104|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365105|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365106|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365107|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365108|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365109|NCT00400153|E3|Reported Event|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
365110|NCT00400153|E2|Reported Event|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
365111|NCT00400153|E1|Reported Event|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
365112|NCT00400179|B3|Baseline|Total|Total of all reporting groups
365113|NCT00400179|B2|Baseline|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
365114|NCT00400179|B1|Baseline|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.
Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
365115|NCT00400179|P2|Participant Flow|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
365116|NCT00400179|P1|Participant Flow|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.
Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
365259|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365117|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
365118|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.
Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
365119|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
365120|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.
Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
365121|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
365122|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.
Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
365123|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
365144|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365218|NCT00402051|E2|Reported Event|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
365124|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.
Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
365125|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
365126|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.
Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
365127|NCT00400179|E2|Reported Event|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
365128|NCT00400179|E1|Reported Event|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.
Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
365129|NCT00400205|B1|Baseline|TPF Induction Therapy for Head and Neck Cancer|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with TPF followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
365130|NCT00400205|P1|Participant Flow|TPF Induction in Head and Neck Cancer|Phase II single arm study of TPF induction therapy in patients with head and neck cancer.
365131|NCT00400205|O1|Outcome|TPF Induction in Head and Neck Cancer|Phase II single arm study of TPF induction therapy in patients with head and neck cancer.
365132|NCT00400205|E1|Reported Event|TPF Induction Therapy for Head and Neck Cancer|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with TPF followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
365133|NCT00401973|B4|Baseline|Total|Total of all reporting groups
365134|NCT00401973|B3|Baseline|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365135|NCT00401973|B2|Baseline|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365136|NCT00401973|B1|Baseline|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365137|NCT00401973|P3|Participant Flow|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365138|NCT00401973|P2|Participant Flow|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365139|NCT00401973|P1|Participant Flow|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365140|NCT00401973|O2|Outcome|22 Weeks|"Combined treatment groups:
olanzapine plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks].
Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)].
Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)]."
365141|NCT00401973|O1|Outcome|2 Weeks|"Combined treatment groups:
olanzapine plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks].
Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)].
Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)]."
365142|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365143|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365145|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365146|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365147|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365148|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365149|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365150|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365151|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365152|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365153|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365154|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365155|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365156|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365157|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365158|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365159|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365160|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365161|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365162|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365163|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365164|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365165|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365166|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365167|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365168|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365169|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365783|NCT00402987|O3|Outcome|Placebo|
365170|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365171|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365172|NCT00401973|E3|Reported Event|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365173|NCT00401973|E2|Reported Event|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.
olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
365174|NCT00401973|E1|Reported Event|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
365175|NCT00402025|B4|Baseline|Total|Total of all reporting groups
365176|NCT00402025|B3|Baseline|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365177|NCT00402025|B2|Baseline|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365178|NCT00402025|B1|Baseline|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365179|NCT00402025|P3|Participant Flow|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365180|NCT00402025|P2|Participant Flow|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365181|NCT00402025|P1|Participant Flow|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴plaque-forming units (PFU)/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365350|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
365733|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365182|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365183|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365184|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365185|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365186|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365187|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365188|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365189|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365216|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
365217|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
365190|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365191|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365192|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365193|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365194|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365195|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365196|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365197|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365198|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365412|NCT00402337|B6|Baseline|Total|Total of all reporting groups
365413|NCT00402337|B5|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
365414|NCT00402337|B4|Baseline|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
365199|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365200|NCT00402025|E3|Reported Event|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365201|NCT00402025|E2|Reported Event|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365202|NCT00402025|E1|Reported Event|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.
At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
365203|NCT00402051|B3|Baseline|Total|Total of all reporting groups
365204|NCT00402051|B2|Baseline|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
365205|NCT00402051|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
365206|NCT00402051|P2|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
365207|NCT00402051|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
365208|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
365209|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
365210|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
365211|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
365212|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
365213|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
365214|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
365215|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
365784|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365219|NCT00402051|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
365220|NCT00402103|B3|Baseline|Total|Total of all reporting groups
365221|NCT00402103|B2|Baseline|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
365222|NCT00402103|B1|Baseline|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
365223|NCT00402103|P2|Participant Flow|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
365224|NCT00402103|P1|Participant Flow|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
365225|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
365226|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
365227|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
365228|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
365229|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
365230|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
365231|NCT00402103|O3|Outcome|Aliskiren 300mg/ Amlodipine 10mg/ HCTZ|Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
365232|NCT00402103|O2|Outcome|Aliskiren 300mg/ Amlodipine 10mg Alone|Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
365233|NCT00402103|O1|Outcome|Aliskiren 150mg/ Amlodipine 5mg Alone|Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
365234|NCT00402103|E3|Reported Event|Aliskiren 300mg/ Amlodipine 10mg/ HCTZ|Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
365235|NCT00402103|E2|Reported Event|Aliskiren 300mg/ Amlodipine 10mg Alone|Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
365236|NCT00402103|E1|Reported Event|Aliskiren 150mg/ Amlodipine 5mg Alone|Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
365237|NCT00402168|B3|Baseline|Total|Total of all reporting groups
365238|NCT00402168|B2|Baseline|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365239|NCT00402168|B1|Baseline|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365415|NCT00402337|B3|Baseline|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
365240|NCT00402168|P2|Participant Flow|Calcineurin Inhibitor (CNI)|Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365241|NCT00402168|P1|Participant Flow|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.
365242|NCT00402168|O1|Outcome|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants were allowed to switch from CNI to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.
365243|NCT00402168|O1|Outcome|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants who had been randomized to CNI were allowed to switch to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.
365244|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365245|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365246|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365247|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365248|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365249|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365271|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365376|NCT00402285|O2|Outcome|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).
men took fish oil & placebo for lycopene."
365250|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365251|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365252|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365253|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365254|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365255|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365256|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365257|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365258|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365734|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365260|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365261|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365262|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365263|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365264|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365265|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365266|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365267|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365268|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365269|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365270|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365272|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365273|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365274|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365275|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365276|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365277|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg given IV every 28 days.
365278|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365279|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365280|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365281|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365282|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm by Year 3.
365283|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.
365284|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365285|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365286|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365287|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365288|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365289|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
365290|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
365291|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg was given IV every 28 days.
365320|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365446|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
365292|NCT00402168|E3|Reported Event|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants were allowed to switch from CNI to Belatacept. For those switching to Belatacept, the CNI dose was tapered and discontinued, after which they received Belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received Belatacept 5 mg/kg IV every 28 days. Adverse events reported for participants who were switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period on or after their first Belatacept dose.
365293|NCT00402168|E2|Reported Event|Calcineurin Inhibitor (CNI)|Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to Belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the Belatacept arm. Adverse events reported for participants who were treated with only CNI for the entire study and those who were later switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period prior to their first Belatacept dose.
365294|NCT00402168|E1|Reported Event|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days. Adverse events reported for participants who were treated with only Belatacept throughout the study.
365295|NCT00402194|B3|Baseline|Total|Total of all reporting groups
365296|NCT00402194|B2|Baseline|Placebo|Placebo
365297|NCT00402194|B1|Baseline|Treatment|Treatment with 100mg of losartan daily or placebo. Outcomes measured before and after 3 months of treatment.
365298|NCT00402194|P2|Participant Flow|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
365299|NCT00402194|P1|Participant Flow|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
365300|NCT00402194|O2|Outcome|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
365301|NCT00402194|O1|Outcome|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
365302|NCT00402194|O2|Outcome|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
365303|NCT00402194|O1|Outcome|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
365304|NCT00402194|E2|Reported Event|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
365305|NCT00402194|E1|Reported Event|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
365306|NCT00402233|B5|Baseline|Total|Total of all reporting groups
365735|NCT00402987|O3|Outcome|Placebo|
365307|NCT00402233|B4|Baseline|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365308|NCT00402233|B3|Baseline|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365309|NCT00402233|B2|Baseline|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365310|NCT00402233|B1|Baseline|Placebo|matching tablet
365311|NCT00402233|P4|Participant Flow|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365312|NCT00402233|P3|Participant Flow|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365313|NCT00402233|P2|Participant Flow|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365314|NCT00402233|P1|Participant Flow|Placebo|matching tablet
365315|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365316|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365317|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365318|NCT00402233|O1|Outcome|Placebo|matching tablet
365319|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365321|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365322|NCT00402233|O1|Outcome|Placebo|matching tablet
365323|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365324|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365325|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365326|NCT00402233|O1|Outcome|Placebo|matching tablet
365327|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365328|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365329|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365330|NCT00402233|O1|Outcome|Placebo|matching tablet
365331|NCT00402233|E4|Reported Event|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365417|NCT00402337|B1|Baseline|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
365418|NCT00402337|P5|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
365332|NCT00402233|E3|Reported Event|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365333|NCT00402233|E2|Reported Event|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
365334|NCT00402233|E1|Reported Event|Placebo|matching tablet
365335|NCT00402246|B3|Baseline|Total|Total of all reporting groups
365336|NCT00402246|B2|Baseline|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
365337|NCT00402246|B1|Baseline|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365338|NCT00402246|P2|Participant Flow|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
365339|NCT00402246|P1|Participant Flow|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365340|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
365341|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
365342|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
365343|NCT00402246|O1|Outcome|Clinicians|Clinicians who responded to the survey
365344|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
365375|NCT00402285|O3|Outcome|Placebo|men took placebo for lycopene & placebo for fish oil.
365447|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
365345|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365346|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
365347|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365348|NCT00402246|O1|Outcome|Patients With a Study CRT-D Device|Patients in either the Remote Arm or the In-office Arm who were implanted with a study CRT-D Device, as these are the only devices that have Left Ventricular leads
365349|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365351|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365352|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
365353|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365354|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
365355|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365356|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365357|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365358|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365359|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
365360|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365361|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
365416|NCT00402337|B2|Baseline|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day. One patient was randomized into the study but did not receive ≥ 1 dose of study drug, thus was not included in the Safety Population.
365362|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365363|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
365364|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365365|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
365366|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
365367|NCT00402246|E1|Reported Event|Enrolled Subjects|All enrolled subjects in the study
365368|NCT00402285|B4|Baseline|Total|Total of all reporting groups
365369|NCT00402285|B3|Baseline|Placebo|men took placebo for lycopene & placebo for fish oil.
365370|NCT00402285|B2|Baseline|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).
men took fish oil & placebo for lycopene."
365371|NCT00402285|B1|Baseline|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
365372|NCT00402285|P3|Participant Flow|Placebo|men took placebo for lycopene & placebo for fish oil.
365373|NCT00402285|P2|Participant Flow|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).
men took fish oil & placebo for lycopene."
365374|NCT00402285|P1|Participant Flow|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
365377|NCT00402285|O1|Outcome|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
365378|NCT00402285|E1|Reported Event|All Participants|
365379|NCT00402324|B3|Baseline|Total|Total of all reporting groups
365380|NCT00402324|B2|Baseline|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365381|NCT00402324|B1|Baseline|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365382|NCT00402324|P2|Participant Flow|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365383|NCT00402324|P1|Participant Flow|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365384|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365385|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365386|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365387|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365388|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365389|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365390|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365391|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365392|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365393|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365394|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365395|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365396|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365397|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365398|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365399|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365400|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365401|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365448|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
365785|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365402|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365403|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365404|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365405|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365406|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365407|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365408|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
365409|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
365410|NCT00402324|E2|Reported Event|Placebo|Placebo: placebo capsules, PO, at Q HS, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following dose achieved in Study Period I).
365411|NCT00402324|E1|Reported Event|Olanzapine|Olanzapine: 15mg, capsules, PO at Q HS, daily for 1 week followed by 5-20mg, capsules, PO at Q HS daily for 5 weeks (6 weeks total). Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following d ose achieved in Study Period I)
365419|NCT00402337|P4|Participant Flow|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
365420|NCT00402337|P3|Participant Flow|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
365421|NCT00402337|P2|Participant Flow|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
365422|NCT00402337|P1|Participant Flow|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
365423|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
365424|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
365425|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
365426|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
365427|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
365428|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
365429|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
365430|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
365431|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
365432|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
365433|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
365434|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
365435|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
365436|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
365437|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
365438|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
365439|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
365440|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
365441|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
365442|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
365443|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
365444|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
365445|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
365449|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
365450|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
365451|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
365452|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
365453|NCT00402337|E5|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
365454|NCT00402337|E4|Reported Event|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
365455|NCT00402337|E3|Reported Event|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
365456|NCT00402337|E2|Reported Event|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
365457|NCT00402337|E1|Reported Event|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
365458|NCT00402363|B5|Baseline|Total|Total of all reporting groups
365459|NCT00402363|B4|Baseline|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
365460|NCT00402363|B3|Baseline|Persistent AF, P-OM3|Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
365461|NCT00402363|B2|Baseline|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
365462|NCT00402363|B1|Baseline|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
365463|NCT00402363|P4|Participant Flow|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
365464|NCT00402363|P3|Participant Flow|Persistent AF, P-OM3|Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
365725|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365465|NCT00402363|P2|Participant Flow|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
365466|NCT00402363|P1|Participant Flow|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
365467|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365468|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
365469|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365470|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
365471|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365472|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
365473|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365474|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
365475|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365476|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
365477|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365478|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
365479|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365480|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
365786|NCT00402987|O4|Outcome|Placebo|
365481|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365482|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
365483|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365484|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
365485|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365486|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
365487|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365488|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
365489|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365490|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
365491|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365492|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
365493|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365494|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
365495|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365496|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
365497|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365498|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
365499|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365500|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
365501|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365502|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
365503|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365504|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
365505|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365506|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
365507|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365508|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
365509|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365510|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
365511|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365512|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
365513|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365514|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
365515|NCT00402363|O4|Outcome|Combined, P-OM3|Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365516|NCT00402363|O3|Outcome|Combined, Placebo|Participants with both paroxysmal and persistent AF receiving matching placebo
365517|NCT00402363|O2|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365518|NCT00402363|O1|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
365519|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365520|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
365521|NCT00402363|E2|Reported Event|Prescription Omega-3 Acid Ethyl Esters|Participants receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
365522|NCT00402363|E1|Reported Event|Placebo|Participants receiving matching placebo
365523|NCT00402597|B6|Baseline|Total|Total of all reporting groups
365524|NCT00402597|B5|Baseline|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
365787|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
365525|NCT00402597|B4|Baseline|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
365526|NCT00402597|B3|Baseline|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
365527|NCT00402597|B2|Baseline|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
365528|NCT00402597|B1|Baseline|Placebo|One placebo tablet twice daily for 6 months.
365529|NCT00402597|P5|Participant Flow|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
365530|NCT00402597|P4|Participant Flow|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
365531|NCT00402597|P3|Participant Flow|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
365532|NCT00402597|P2|Participant Flow|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
365533|NCT00402597|P1|Participant Flow|Placebo|One placebo tablet twice daily for 6 months.
365534|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
365535|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
365536|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
365537|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
365538|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
365539|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
365540|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
365541|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
365542|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
365543|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
365544|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
365545|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
365546|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
365547|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
365548|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
365549|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
365550|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
365551|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
365552|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
365553|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
365554|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
365555|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
365556|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
365557|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
365558|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
365559|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
365560|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
365561|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
365562|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
365563|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
365564|NCT00402597|E5|Reported Event|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
365565|NCT00402597|E4|Reported Event|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
365566|NCT00402597|E3|Reported Event|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
365567|NCT00402597|E2|Reported Event|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
365568|NCT00402597|E1|Reported Event|Placebo|One placebo tablet twice daily for 6 months.
365569|NCT00402649|B1|Baseline|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
365570|NCT00402649|P1|Participant Flow|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
365571|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
365572|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
365573|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
365574|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
365575|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
365576|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
365577|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
365578|NCT00402649|E1|Reported Event|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
365579|NCT00402688|B4|Baseline|Total|Total of all reporting groups
365580|NCT00402688|B3|Baseline|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
365581|NCT00402688|B2|Baseline|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
365582|NCT00402688|B1|Baseline|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
365583|NCT00402688|P3|Participant Flow|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
365584|NCT00402688|P2|Participant Flow|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
365585|NCT00402688|P1|Participant Flow|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
365586|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
365587|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
365588|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
365589|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
365590|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
365591|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
365592|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
365593|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
365594|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
365595|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
365596|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
365597|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
365598|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
365599|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
365600|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
365601|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
365602|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
365603|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
365604|NCT00402688|E3|Reported Event|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
365605|NCT00402688|E2|Reported Event|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
365606|NCT00402688|E1|Reported Event|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
365607|NCT00402714|B3|Baseline|Total|Total of all reporting groups
365608|NCT00402714|B2|Baseline|2 Pent/TBI|"Pentostatin and total body irradiation
Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
365609|NCT00402714|B1|Baseline|1 ECP and Pent/TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation
extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.
Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
365610|NCT00402714|P2|Participant Flow|Pent|"Pentostatin and total body irradiation
Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
365611|NCT00402714|P1|Participant Flow|ECP/Pent|"Extracorporeal photopheresis, pentostatin and total body irradiation
extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.
Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
365612|NCT00402714|O2|Outcome|Pento TBI|"Pentostatin and total body irradiation
Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
365613|NCT00402714|O1|Outcome|ECP Pento TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation
extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.
Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
365614|NCT00402714|O2|Outcome|2 Pent/TBI|"Pentostatin and total body irradiation
Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
365615|NCT00402714|O1|Outcome|1 ECP and Pent/TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation
extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.
Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
365616|NCT00402714|E2|Reported Event|Pent|"Pentostatin and total body irradiation
Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
365673|NCT00402987|P3|Participant Flow|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
365788|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
365617|NCT00402714|E1|Reported Event|ECP/Pent|"Extracorporeal photopheresis, pentostatin and total body irradiation
extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.
Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
365618|NCT00402727|B3|Baseline|Total|Total of all reporting groups
365619|NCT00402727|B2|Baseline|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365620|NCT00402727|B1|Baseline|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365621|NCT00402727|P2|Participant Flow|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365622|NCT00402727|P1|Participant Flow|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365623|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365624|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365625|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365626|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365627|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365628|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365629|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365630|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365726|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365727|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365631|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365632|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365633|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365634|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365635|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365636|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365637|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365638|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365639|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365640|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365641|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365642|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365674|NCT00402987|P2|Participant Flow|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
365789|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365643|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365644|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365645|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365646|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365647|NCT00402727|E2|Reported Event|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
365648|NCT00402727|E1|Reported Event|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
365649|NCT00402740|B1|Baseline|Group 1|
365650|NCT00402740|P1|Participant Flow|Group 1|
365651|NCT00402740|O1|Outcome|Group 1|
365652|NCT00402740|O1|Outcome|Group 1|
365653|NCT00402740|O1|Outcome|Group 1|
365654|NCT00402740|O3|Outcome|Emboshield Gen 3|Participants receiving Emboshield Gen 3 Emboshield Gen3 success were counted per filter.
365655|NCT00402740|O2|Outcome|Emboshield Pro Gen 5|Participants receiving Emboshield Pro Gen 5. Emboshield Pro success were counted per filter.
365656|NCT00402740|O1|Outcome|Xact Stent|The Xact stent success were counted per subject
365657|NCT00402740|O1|Outcome|Group 1|Includes only the most serious event for each subject and includes only each subject's first occurrence of the event.
365658|NCT00402740|E1|Reported Event|Group 1|
365659|NCT00402883|B1|Baseline|Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
365728|NCT00402987|O3|Outcome|Placebo|
365729|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365730|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365731|NCT00402987|O4|Outcome|Placebo|
365732|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365660|NCT00402883|P1|Participant Flow|Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab|"Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines.
Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy."
365661|NCT00402883|O1|Outcome|Intervention|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
365662|NCT00402883|E1|Reported Event|Intervention|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
365663|NCT00402896|B1|Baseline|ZD6474|300 mg/day orally for 10 weeks.
365664|NCT00402896|P1|Participant Flow|ZD6474|300 mg/day orally for 10 weeks.
365665|NCT00402896|O1|Outcome|ZD6474|300 mg/day orally for 10 weeks.
365666|NCT00402896|E1|Reported Event|ZD6474|300 mg/day orally for 10 weeks.
365667|NCT00402987|B5|Baseline|Total|Total of all reporting groups
365668|NCT00402987|B4|Baseline|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
365669|NCT00402987|B3|Baseline|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
365670|NCT00402987|B2|Baseline|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
365671|NCT00402987|B1|Baseline|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
365672|NCT00402987|P4|Participant Flow|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
365779|NCT00402987|O4|Outcome|Placebo|
365675|NCT00402987|P1|Participant Flow|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
365676|NCT00402987|O4|Outcome|Placebo|
365677|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365678|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365679|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365680|NCT00402987|O4|Outcome|Placebo|
365681|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365682|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365683|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365684|NCT00402987|O4|Outcome|Placebo|
365685|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365686|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
365687|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365688|NCT00402987|O4|Outcome|Placebo|
365689|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365690|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
365691|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365692|NCT00402987|O4|Outcome|Placebo|
365693|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365694|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365695|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365696|NCT00402987|O4|Outcome|Placebo|
365697|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365698|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365699|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365700|NCT00402987|O3|Outcome|Placebo|
365701|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365702|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365703|NCT00402987|O4|Outcome|Placebo|
365704|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365705|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365706|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365707|NCT00402987|O3|Outcome|Placebo|
365708|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365709|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365710|NCT00402987|O4|Outcome|Placebo|
365711|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365712|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
365713|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365714|NCT00402987|O3|Outcome|Placebo|
365715|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365716|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365717|NCT00402987|O4|Outcome|Placebo|
365718|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365719|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365720|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365721|NCT00402987|O3|Outcome|Placebo|
365722|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365723|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365724|NCT00402987|O4|Outcome|Placebo|
365736|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365737|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365738|NCT00402987|O4|Outcome|Placebo|
365739|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365740|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
365741|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365742|NCT00402987|O3|Outcome|Placebo|
365743|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365744|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365745|NCT00402987|O4|Outcome|Placebo|
365746|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365747|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365748|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365749|NCT00402987|O3|Outcome|Placebo|
365750|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365751|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365752|NCT00402987|O4|Outcome|Placebo|
365753|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365754|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365755|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365756|NCT00402987|O3|Outcome|Placebo|
365757|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365758|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365759|NCT00402987|O3|Outcome|Placebo|
365760|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365761|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365762|NCT00402987|O4|Outcome|Placebo|
365763|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365764|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365765|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365766|NCT00402987|O3|Outcome|Placebo|
365767|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365768|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365769|NCT00402987|O4|Outcome|Placebo|
365770|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
365771|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
365772|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365773|NCT00402987|O3|Outcome|Placebo|
365774|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365775|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365776|NCT00402987|O3|Outcome|Placebo|
365777|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365778|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365791|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
365792|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365793|NCT00402987|O3|Outcome|Placebo|
365794|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
365795|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365796|NCT00402987|O3|Outcome|Placebo|
365797|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
365798|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365799|NCT00402987|O3|Outcome|Placebo|
365800|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
365801|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365802|NCT00402987|O4|Outcome|Placebo|
365803|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
365804|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
365805|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365806|NCT00402987|O3|Outcome|Placebo|
365807|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
365808|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365809|NCT00402987|O4|Outcome|Placebo|
365810|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
365811|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
365812|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365813|NCT00402987|O3|Outcome|Placebo|
365814|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
365815|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365816|NCT00402987|O4|Outcome|Placebo|
365817|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
365818|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
365819|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365820|NCT00402987|O3|Outcome|Placebo|
365821|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
365822|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
365823|NCT00402987|O4|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
365824|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
365825|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
365826|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
365827|NCT00402987|O3|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
365828|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled
365829|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
365830|NCT00402987|O2|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
365831|NCT00402987|O1|Outcome|Celecoxib 100mg (Pooled)|Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled
365832|NCT00402987|E4|Reported Event|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
365833|NCT00402987|E3|Reported Event|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
365834|NCT00402987|E2|Reported Event|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
365835|NCT00402987|E1|Reported Event|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
365836|NCT00403130|B1|Baseline|Gemcitabine + Paclitaxel + Bevacizumab|
365837|NCT00403130|P1|Participant Flow|Gemcitabine + Paclitaxel + Bevacizumab|
365838|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
365839|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
365840|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
365841|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
365842|NCT00403130|E1|Reported Event|Gemcitabine + Paclitaxel + Bevacizumab|
365843|NCT00403234|B5|Baseline|Total|Total of all reporting groups
365844|NCT00403234|B4|Baseline|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
365845|NCT00403234|B3|Baseline|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
365846|NCT00403234|B2|Baseline|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
365847|NCT00403234|B1|Baseline|Placebo|Placebo transdermal patch applied for 7-day wear
365848|NCT00403234|P4|Participant Flow|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
365849|NCT00403234|P3|Participant Flow|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
365850|NCT00403234|P2|Participant Flow|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
365851|NCT00403234|P1|Participant Flow|Placebo|Placebo transdermal patch applied for 7-day wear.
365852|NCT00403234|O4|Outcome|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
365853|NCT00403234|O3|Outcome|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
365854|NCT00403234|O2|Outcome|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
365855|NCT00403234|O1|Outcome|Placebo|Placebo transdermal patch applied for 7-day wear
365856|NCT00403234|E4|Reported Event|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
365857|NCT00403234|E3|Reported Event|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
365858|NCT00403234|E2|Reported Event|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
365859|NCT00403234|E1|Reported Event|Placebo|Placebo transdermal patch applied for 7-day wear.
365860|NCT00403273|B3|Baseline|Total|Total of all reporting groups
365861|NCT00403273|B2|Baseline|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365862|NCT00403273|B1|Baseline|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365863|NCT00403273|P2|Participant Flow|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
366015|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
365864|NCT00403273|P1|Participant Flow|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365865|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365866|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365867|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365868|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365869|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365870|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365871|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365872|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365873|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365874|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365875|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365876|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365877|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365878|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365879|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365880|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365881|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365882|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365883|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365884|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365885|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365886|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
366255|NCT00395044|B2|Baseline|Placebo|1200mg/d of Placebo
365887|NCT00403273|E2|Reported Event|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
365888|NCT00403273|E1|Reported Event|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
365889|NCT00403403|B3|Baseline|Total|Total of all reporting groups
365890|NCT00403403|B2|Baseline|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365891|NCT00403403|B1|Baseline|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365892|NCT00403403|P2|Participant Flow|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365893|NCT00403403|P1|Participant Flow|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
366078|NCT00404092|O4|Outcome|4th Cohort|"200mg 1x/day
caspofungin : i.v."
366079|NCT00404092|O3|Outcome|3rd Cohort|"150mg 1x/day
caspofungin : i.v."
365894|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365895|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365896|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365897|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365898|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365899|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365900|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
366256|NCT00395044|B1|Baseline|Gabapentin|1200 mg/daily of Gabapentin
365901|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365902|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365903|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365904|NCT00403403|E2|Reported Event|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
365905|NCT00403403|E1|Reported Event|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
366080|NCT00404092|O2|Outcome|2nd Cohort|"100mg 1x/day
caspofungin : i.v."
365906|NCT00403455|B1|Baseline|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
365907|NCT00403455|P1|Participant Flow|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
365908|NCT00403455|O1|Outcome|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
365909|NCT00403455|E1|Reported Event|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
365910|NCT00403481|B1|Baseline|Active Treatmant Arm|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
365911|NCT00403481|P1|Participant Flow|Active Treatment Period|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
365912|NCT00403481|O1|Outcome|Overall Study Population|
365913|NCT00403481|O1|Outcome|Overall Study Population|
365914|NCT00403481|O1|Outcome|Overall Study Population|
365915|NCT00403481|O1|Outcome|Overall Study Population|
365916|NCT00403481|O1|Outcome|Overall Study Population|
365917|NCT00403481|O1|Outcome|Overall Study Population|
365918|NCT00403481|O1|Outcome|Overall Study Population|
365919|NCT00403481|O1|Outcome|Overall Study Population|
365920|NCT00403481|O1|Outcome|Overall Study Population|
365921|NCT00403481|E4|Reported Event|Olmesartan 40 mg and Hydrochlorothiazide 25 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
366246|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366257|NCT00395044|P2|Participant Flow|Placebo|Matched Placebo
365922|NCT00403481|E3|Reported Event|Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
365923|NCT00403481|E2|Reported Event|Olmesartan 40 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
365924|NCT00403481|E1|Reported Event|Olmesartan 20 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
365925|NCT00403546|B3|Baseline|Total|Total of all reporting groups
365926|NCT00403546|B2|Baseline|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365927|NCT00403546|B1|Baseline|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365928|NCT00403546|P3|Participant Flow|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
366016|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
366017|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
365929|NCT00403546|P2|Participant Flow|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365930|NCT00403546|P1|Participant Flow|Standard Treatment Ziprasidone|Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day [160 mg/d]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial. Participants who were already taking standard treatment ziprasidone for 3 weeks or longer at time of enrollment were eligible for screening, as well.
365931|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365932|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365933|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365934|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365935|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365936|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
366247|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366248|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
365937|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365938|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365939|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365940|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365941|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365942|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365943|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
366018|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
366019|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
365944|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365945|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365946|NCT00403546|O1|Outcome|High Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365947|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365948|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365949|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365950|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365951|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
366809|NCT00395850|B1|Baseline|Placebo|microcrystalline cellulose
365952|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365953|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365954|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365955|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365956|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365957|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365958|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365992|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365959|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365960|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365961|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365962|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365963|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
365964|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365965|NCT00403546|E4|Reported Event|Placebo, Standard Treatment Ziprasidone Randomized Trial|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
366051|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
365966|NCT00403546|E3|Reported Event|High-Dose Ziprasidone Randomized Trial|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
365967|NCT00403546|E2|Reported Event|Standard Treatment Ziprasidone Screening Phase|Participants who had taken standard treatment ziprasidone for 3 weeks or longer were eligible for screening to enter the randomized trial.
365968|NCT00403546|E1|Reported Event|Standard Treatment Ziprasidone Open-label Phase|Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day [160 mg/d]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial.
365969|NCT00403585|B1|Baseline|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
365970|NCT00403585|P1|Participant Flow|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
365971|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
365972|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
365973|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
365974|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
365975|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
365976|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
365977|NCT00403585|E1|Reported Event|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
365978|NCT00403754|B1|Baseline|Entire Study Population|"The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in the 4 different sequences of the core phase. Two capsules of study medication were inhaled in the morning on Day 1 of each treatment period. Following the core phase patients continued to the Salmeterol open label phase. Salmeterol was inhaled via a Diskus inhalation device 50 µg in the morning and 50 µg 12 hours post initial dose on Day 1. Patients received each treatment only once.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365979|NCT00403754|P4|Participant Flow|Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol|"In treatment period 1: patients received 2 indacaterol (Ind) 300 μg capsules; in treatment period 2: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 placebo capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t"
366074|NCT00404092|P4|Participant Flow|4th Cohort|"200mg 1x/day
caspofungin : i.v."
366075|NCT00404092|P3|Participant Flow|3rd Cohort|"150mg 1x/day
caspofungin : i.v."
365980|NCT00403754|P3|Participant Flow|Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol|"In treatment period 1: patients received 1 indacaterol (Ind) 300 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 placebo capsules; in treatment period 3: patients received 2 indacaterol 300 μg capsules; and in treatment period 4: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t"
365981|NCT00403754|P2|Participant Flow|Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol|"In treatment period 1: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 indacaterol 300 μg capsules; in treatment period 3: patients received 2 placebo capsules; and in treatment period 4: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365982|NCT00403754|P1|Participant Flow|Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol|"In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 indacaterol 300 μg capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
366249|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366250|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
365983|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365984|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365985|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365986|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365987|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365988|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365989|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365990|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365991|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
366014|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
365993|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365994|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365995|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365996|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365997|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
365998|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
366052|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
365999|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
366000|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
366001|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
366002|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
366003|NCT00403754|E5|Reported Event|Salmeterol 100 μg|Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
366004|NCT00403754|E4|Reported Event|Placebo|"2 Placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Placebo treatment period.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
366005|NCT00403754|E3|Reported Event|Indacaterol 600 μg|"2 Indacaterol 300 μg capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 600 μg treatment period.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
366006|NCT00403754|E2|Reported Event|Indacaterol 300 μg|"1 Indacaterol 300 μg capsules + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 300 μg treatment period.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
366007|NCT00403754|E1|Reported Event|Indacaterol 150 μg|"1 Indacaterol 150 μg capsule + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 150 μg treatment period.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
366008|NCT00403767|B3|Baseline|Total|Total of all reporting groups
366009|NCT00403767|B2|Baseline|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
366010|NCT00403767|B1|Baseline|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
366011|NCT00403767|P2|Participant Flow|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
366012|NCT00403767|P1|Participant Flow|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
366013|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
366020|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
366021|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
366022|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
366023|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
366024|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
366025|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
366026|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
366027|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
366028|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
366029|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
366030|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
366031|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
366032|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
366033|NCT00403767|E2|Reported Event|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
366034|NCT00403767|E1|Reported Event|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
366142|NCT00404352|P3|Participant Flow|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
366035|NCT00403845|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in 4 different sequences. Two capsules of study medication were inhaled in the morning between 8:00 and 10:00 am on Day 1 of each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366036|NCT00403845|P4|Participant Flow|Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo|In treatment period 1, patients received 2 indacaterol 300 μg capsules; in treatment period 2, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4 patients received 2 placebo capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366037|NCT00403845|P3|Participant Flow|Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg|In treatment period 1, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 placebo capsules; in treatment period 3, patients received 2 indacaterol 300 μg capsules; and in treatment period 4, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366038|NCT00403845|P2|Participant Flow|Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg|In treatment period 1, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 indacaterol 300 μg capsules; in treatment period 3, patients received 2 placebo capsules; and in treatment period 4, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366039|NCT00403845|P1|Participant Flow|Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg|In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366040|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366041|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366042|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366043|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366044|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366076|NCT00404092|P2|Participant Flow|2nd Cohort|"100mg 1x/day
caspofungin : i.v."
366077|NCT00404092|P1|Participant Flow|1st Cohort|"70mg 1x/day
caspofungin : i.v."
366045|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366046|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366047|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366048|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366049|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366050|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366251|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366053|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366054|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366055|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366056|NCT00403845|E4|Reported Event|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366057|NCT00403845|E3|Reported Event|Indacaterol 300 μg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366058|NCT00403845|E2|Reported Event|Indacaterol 150 μg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366059|NCT00403845|E1|Reported Event|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
366060|NCT00404079|B3|Baseline|Total|Total of all reporting groups
366061|NCT00404079|B2|Baseline|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
366062|NCT00404079|B1|Baseline|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
366063|NCT00404079|P2|Participant Flow|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
366064|NCT00404079|P1|Participant Flow|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
366065|NCT00404079|O2|Outcome|Glucosamine Sulphate|Glucosamine sulphate was taken daily and orally in capsule forms for 6 months
366066|NCT00404079|O1|Outcome|Placebo|Oral intake of placebo capsules
366067|NCT00404079|E2|Reported Event|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
366068|NCT00404079|E1|Reported Event|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
366069|NCT00404092|B5|Baseline|Total|Total of all reporting groups
366070|NCT00404092|B4|Baseline|4th Cohort|"200mg 1x/day
caspofungin : i.v."
366071|NCT00404092|B3|Baseline|3rd Cohort|"150mg 1x/day
caspofungin : i.v."
366072|NCT00404092|B2|Baseline|2nd Cohort|"100mg 1x/day
caspofungin : i.v."
366073|NCT00404092|B1|Baseline|1st Cohort|"70mg 1x/day
caspofungin : i.v."
366081|NCT00404092|O1|Outcome|1st Cohort|"70mg 1x/day
caspofungin : i.v."
366082|NCT00404092|O4|Outcome|4th Cohort|"200mg 1x/day
caspofungin : i.v."
366083|NCT00404092|O3|Outcome|3rd Cohort|"150mg 1x/day
caspofungin : i.v."
366084|NCT00404092|O2|Outcome|2nd Cohort|"100mg 1x/day
caspofungin : i.v."
366085|NCT00404092|O1|Outcome|1st Cohort|"70mg 1x/day
caspofungin : i.v."
366086|NCT00404092|E4|Reported Event|4th Cohort|"200mg 1x/day
caspofungin : i.v."
366087|NCT00404092|E3|Reported Event|3rd Cohort|"150mg 1x/day
caspofungin : i.v."
366088|NCT00404092|E2|Reported Event|2nd Cohort|"100mg 1x/day
caspofungin : i.v."
366089|NCT00404092|E1|Reported Event|1st Cohort|"70mg 1x/day
caspofungin : i.v."
366090|NCT00404248|B4|Baseline|Total|Total of all reporting groups
366091|NCT00404248|B3|Baseline|Arm 3 no Stratification (+EIASD or -EIASD)|"Subjects were not stratified by antiseizure drugs
Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Only dose tested: 2200.
NO intrasubject dose escalation.
PK (pharmacological study) data will be collected on day one of cycle one infusion"
366092|NCT00404248|B2|Baseline|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.
PK (pharmacological study) data will be collected on day one of cycle one infusion"
366093|NCT00404248|B1|Baseline|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.
PK (pharmacological study) data will be collected on day one of cycle one infusion"
366094|NCT00404248|P9|Participant Flow|Arm 9 - Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-sezuire medication..
Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day. New formulation TC6."
366143|NCT00404352|P2|Participant Flow|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
366095|NCT00404248|P8|Participant Flow|Arm 8 -EIASD Level 4|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion"
366096|NCT00404248|P7|Participant Flow|Arm 7 -EIASD Level 3|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation. this Arm including pts treated at the new formulation TC6 at 1700mg
PK data will be collected on day one of cycle one infusion"
366097|NCT00404248|P6|Participant Flow|Arm 6 -EIASD Level 2|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion"
366098|NCT00404248|P5|Participant Flow|Arm 5 Non-Enzyme Inducing Antiseizure Drug (-EIASD) Level 1|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion"
366099|NCT00404248|P4|Participant Flow|Arm 4 +EIASD Level 4|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation."
366100|NCT00404248|P3|Participant Flow|Arm 3 +EIASD Level 3|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation. Includes pts at the new formulation TC6 at 1700mg"
366101|NCT00404248|P2|Participant Flow|Arm 2 +EIASD Level 2|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation."
366102|NCT00404248|P1|Participant Flow|Arm 1 Enzyme Inducing Antiseizure Drug (+ EIASD) Level 1|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.
Pharmacokinetics (PK) data will be collected on day one of cycle one infusion"
366103|NCT00404248|O1|Outcome|Phase 1 Terameprocol|"subjects were either on the +EIASD antiseizure durgs: (phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine). or not on antiseizure drugs - or those effecting hepatic enzymes ( -EIASD) such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.
PK (pharmacological study) data will be collected on day one of cycle one infusion"
366104|NCT00404248|O1|Outcome|Phase 1 Terameprocol|"subjects were either on the +EIASD antiseizure durgs: (phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine). or not on antiseizure drugs - or those effecting hepatic enzymes ( -EIASD) such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.
PK (pharmacological study) data will be collected on day one of cycle one infusion"
366120|NCT00404248|O3|Outcome|ARM 3 (No Stratification)|"Subjects in this group were not stratified based on anti-sezuire medication..
Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.
New formulation TC6."
366105|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.
PK (pharmacological study) data will be collected on day one of cycle one infusion"
366106|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.
PK (pharmacological study) data will be collected on day one of cycle one infusion"
366107|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.
PK (pharmacological study) data will be collected on day one of cycle one infusion"
366108|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.
PK (pharmacological study) data will be collected on day one of cycle one infusion"
366109|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.
PK (pharmacological study) data will be collected on day one of cycle one infusion"
366110|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.
PK (pharmacological study) data will be collected on day one of cycle one infusion"
366111|NCT00404248|O9|Outcome|Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-sezuire medication..
Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.
New formulation TC6 - NONPEG or -PEG. (polyethylene glycol )"
366112|NCT00404248|O8|Outcome|-EIASD Level 4 (2200 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366113|NCT00404248|O7|Outcome|-EIASD Level 3 (1700 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation and new TC6 -PEG Formulation - Pts treated from both formulations"
366114|NCT00404248|O6|Outcome|-EIASD Level 2 (1100 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366115|NCT00404248|O5|Outcome|-EIASD Level 1 (750 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366116|NCT00404248|O4|Outcome|+EIASD Level 4 (2200 mg/dayx5D)|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366117|NCT00404248|O3|Outcome|+EIASD Level 3 (1700 mg/dayx5D)|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation; Includes patientss at the new formulation TC6 (-PEG)"
366118|NCT00404248|O2|Outcome|+EIASD Level 2 (1100 mg/dayx5D)|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366119|NCT00404248|O1|Outcome|+ EIASD Level 1 (750 mg/dayx5D)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366293|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
366121|NCT00404248|O2|Outcome|ARM 2 -EIASD (Enzyme-inducing Antizeizure Drug)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Various Dose levels 1= 750mg/dayx5; 2=1100mg/dayx5; 3=1700mg/dayx5; 4=2200mg/dayx5
NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion"
366122|NCT00404248|O1|Outcome|Arm 1 +EIASD (Enzyme-inducing Antizeizure Drug)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Various Dose levels 1= 750mg/dayx5; 2=1100mg/dayx5; 3=1700mg/dayx5; 4=2200mg/dayx5
NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion"
366123|NCT00404248|E9|Reported Event|Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-seizure medication..
Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.
New formulation TC6 - NONPEG or -PEG."
366124|NCT00404248|E8|Reported Event|-EIASD Level 4 (2200 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366125|NCT00404248|E7|Reported Event|-EIASD Level 3 (1700 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion"
366216|NCT00394953|B3|Baseline|Total|Total of all reporting groups
366252|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366253|NCT00395018|E1|Reported Event|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366126|NCT00404248|E6|Reported Event|-EIASD Level 2 (1100 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366127|NCT00404248|E5|Reported Event|-EIASD Level 1 (750 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.
Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366128|NCT00404248|E4|Reported Event|+EIASD Level 4 (2200 mg/dayx5D)|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366129|NCT00404248|E3|Reported Event|+EIASD Level 3 (1700 mg/dayx5D)|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation; Includes pts at the new formulation TC6 (-PEG)"
366130|NCT00404248|E2|Reported Event|+EIASD Level 2 (1100 mg/dayx5D)|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366131|NCT00404248|E1|Reported Event|+ EIASD Level 1 (750 mg/dayx5D)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.
Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.
PK data will be collected on day one of cycle one infusion
+PEG Formulation"
366132|NCT00404352|B4|Baseline|Total|Total of all reporting groups
366133|NCT00404352|B3|Baseline|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
366134|NCT00404352|B2|Baseline|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
366135|NCT00404352|B1|Baseline|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
366136|NCT00404352|P9|Participant Flow|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366200|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366201|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366137|NCT00404352|P8|Participant Flow|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366138|NCT00404352|P7|Participant Flow|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366139|NCT00404352|P6|Participant Flow|Placebo/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
366140|NCT00404352|P5|Participant Flow|RNF 44 Mcg Once Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
366141|NCT00404352|P4|Participant Flow|RNF 44 Mcg Three Times Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
366254|NCT00395044|B3|Baseline|Total|Total of all reporting groups
366144|NCT00404352|P1|Participant Flow|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
366145|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366146|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366147|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366148|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366149|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366150|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366151|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366294|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
366485|NCT00395486|O2|Outcome|Atorvastatin|10mg
366152|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366153|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366154|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366155|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366156|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366217|NCT00394953|B2|Baseline|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
366157|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366158|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366159|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366160|NCT00404352|O3|Outcome|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
366161|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
366162|NCT00404352|O1|Outcome|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
366163|NCT00404352|O3|Outcome|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
366164|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
366165|NCT00404352|O1|Outcome|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
366166|NCT00404352|E9|Reported Event|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366202|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366167|NCT00404352|E8|Reported Event|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366168|NCT00404352|E7|Reported Event|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
366169|NCT00404352|E6|Reported Event|Placebo/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
366170|NCT00404352|E5|Reported Event|RNF 44 Mcg Once Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
366171|NCT00404352|E4|Reported Event|RNF 44 Mcg Three Times Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
366172|NCT00404352|E3|Reported Event|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
366245|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366173|NCT00404352|E2|Reported Event|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
366174|NCT00404352|E1|Reported Event|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
366175|NCT00394524|B3|Baseline|Total|Total of all reporting groups
366176|NCT00394524|B2|Baseline|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
366177|NCT00394524|B1|Baseline|Glucommander|insulin infusion per Glucommander
366178|NCT00394524|P2|Participant Flow|Standard Insulin Infusion|standard continuous insulin infusion with columnar algorithm; dosage or rate of insulin per algorithm
366179|NCT00394524|P1|Participant Flow|Glucommander|continuous insulin infusion per Glucommander, a computer-guided device; dosage or rate of insulin per algorithm
366180|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
366181|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
366182|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
366183|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
366184|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
366185|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
366186|NCT00394524|E2|Reported Event|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
366187|NCT00394524|E1|Reported Event|Glucommander|insulin infusion per Glucommander
366188|NCT00394914|B3|Baseline|Total|Total of all reporting groups
366189|NCT00394914|B2|Baseline|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366190|NCT00394914|B1|Baseline|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366191|NCT00394914|P3|Participant Flow|Placebo|Participants were randomized to receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366192|NCT00394914|P2|Participant Flow|Pleconaril|Participants were randomized to receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366193|NCT00394914|P1|Participant Flow|All Participants (Pre-randomization)|All participants on study prior to randomization.
366194|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366195|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366196|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366197|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366198|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366199|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366290|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
366203|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366204|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366205|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366206|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366207|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366208|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366209|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366210|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366211|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366212|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366213|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366214|NCT00394914|E2|Reported Event|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
366215|NCT00394914|E1|Reported Event|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
366218|NCT00394953|B1|Baseline|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
366219|NCT00394953|P2|Participant Flow|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 to Week 52.
366220|NCT00394953|P1|Participant Flow|MIRCERA|Participants with anemia in chronic kidney disease (CKD) who were on hemodialysis received methoxy polyethylene glycol-epoetin beta (MIRCERA [RO0503821]) intravenously (IV) once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 microgram per month (mcg/month) for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
366221|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
366222|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
366223|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
366224|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
366225|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
366226|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
366227|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
366228|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
366229|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
366291|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
366292|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
366230|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
366231|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
366232|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
366233|NCT00394953|E2|Reported Event|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
366234|NCT00394953|E1|Reported Event|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
366235|NCT00395018|B1|Baseline|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366236|NCT00395018|P1|Participant Flow|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366237|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366238|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366239|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366240|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366241|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366242|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366243|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366244|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
366258|NCT00395044|P1|Participant Flow|Gabapentin|1200 mg/daily of Gabapentin
366259|NCT00395044|O2|Outcome|Placebo|Matched Placebo
366260|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
366261|NCT00395044|O2|Outcome|Placebo|Matched Placebo
366262|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
366263|NCT00395044|O2|Outcome|Placebo|Matched Placebo
366264|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
366265|NCT00395044|O2|Outcome|Placebo|Matched Placebo
366266|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
366267|NCT00395044|O2|Outcome|Placebo|Matched Placebo
366268|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
366269|NCT00395044|O2|Outcome|Placebo|Matched Placebo
366270|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
366271|NCT00395044|O2|Outcome|Placebo|Matched Placebo
366272|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
366273|NCT00395044|E2|Reported Event|Placebo|1200mg/d of Placebo
366274|NCT00395044|E1|Reported Event|Gabapentin|1200 mg/daily of Gabapentin
366275|NCT00395057|B5|Baseline|Total|Total of all reporting groups
366276|NCT00395057|B4|Baseline|Ranibizumab 500 ug|Ranibizumab 500 ug
366277|NCT00395057|B3|Baseline|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
366278|NCT00395057|B2|Baseline|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
366279|NCT00395057|B1|Baseline|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
366280|NCT00395057|P4|Participant Flow|Ranibizumab 500 ug|Ranibizumab 500 ug
366281|NCT00395057|P3|Participant Flow|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
366282|NCT00395057|P2|Participant Flow|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
366283|NCT00395057|P1|Participant Flow|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
366284|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
366285|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
366286|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
366287|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
366288|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
366289|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
366295|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
366296|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
366297|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
366298|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
366299|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
366300|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
366301|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
366302|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
366303|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
366304|NCT00395057|E4|Reported Event|Ranibizumab 500 ug|Ranibizumab 500 ug
366305|NCT00395057|E3|Reported Event|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
366306|NCT00395057|E2|Reported Event|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
366307|NCT00395057|E1|Reported Event|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
366308|NCT00395083|B3|Baseline|Total|Total of all reporting groups
366309|NCT00395083|B2|Baseline|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.
COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
366310|NCT00395083|B1|Baseline|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
366311|NCT00395083|P2|Participant Flow|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.
COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
366312|NCT00395083|P1|Participant Flow|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
366313|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.
COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
366314|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
366348|NCT00395161|P2|Participant Flow|Enteral Whey Protein, IV Saline|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
366761|NCT00395746|P2|Participant Flow|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366315|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.
COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
366316|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
366317|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.
COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
366318|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
366319|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.
COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
366320|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
366321|NCT00395083|E2|Reported Event|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.
COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
366371|NCT00395291|B1|Baseline|Entire Study Population|Includes groups randomized to placebo first and MK-0677 first.
366322|NCT00395083|E1|Reported Event|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
366323|NCT00395135|B3|Baseline|Total|Total of all reporting groups
366324|NCT00395135|B2|Baseline|Year 1 - Matching Placebo BID|matching placebo tablets
366325|NCT00395135|B1|Baseline|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
366326|NCT00395135|P5|Participant Flow|Year 2 - Placebo (Yr 1) / Placebo (Yr 2)|Patients randomized to placebo in Year 1, completed year 1 and randomized to receive placebo in Year 2.
366327|NCT00395135|P4|Participant Flow|Year 2 - Lorc 10 mg BID (Yr 1) / Placebo (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.
366328|NCT00395135|P3|Participant Flow|Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.
366329|NCT00395135|P2|Participant Flow|Year 1 - Matching Placebo BID|matching placebo tablets
366330|NCT00395135|P1|Participant Flow|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
366331|NCT00395135|O3|Outcome|Placebo (Yr 1) / Placebo (Yr 2)|Patients were randomized to placebo in Year 1 and randomized to placebo in Year 2.
366332|NCT00395135|O2|Outcome|Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.
366333|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.
366334|NCT00395135|O2|Outcome|Matching Placebo BID|matching placebo tablets
366335|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
366336|NCT00395135|O2|Outcome|Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|"Patients were randomized to lorcaserin in Year 1, completed year 1 with a Responder status and randomized to placebo in Year 2."
366337|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)|"Patients were randomized to lorcaserin in Year 1, completed year 1 study with a Responder status and randomized to lorcaserin in Year 2."
366338|NCT00395135|O2|Outcome|Matching Placebo BID|matching placebo tablets
366339|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
366340|NCT00395135|E5|Reported Event|Year 2 - Placebo (Yr 1) / Placebo (Yr 2)|matching placebo tablets
366341|NCT00395135|E4|Reported Event|Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|lorcaserin 10 mg BID tablets, matching placebo tablets
366342|NCT00395135|E3|Reported Event|Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)|lorcaserin 10 mg BID tablets
366343|NCT00395135|E2|Reported Event|Year 1 - Matching Placebo BID|matching placebo tablets
366344|NCT00395135|E1|Reported Event|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
366345|NCT00395161|B3|Baseline|Total|Total of all reporting groups
366346|NCT00395161|B2|Baseline|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
366347|NCT00395161|B1|Baseline|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
366349|NCT00395161|P1|Participant Flow|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
366350|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
366351|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
366352|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
366353|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
366354|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
366355|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
366356|NCT00395161|O2|Outcome|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
366357|NCT00395161|O1|Outcome|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
366358|NCT00395161|O2|Outcome|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
366359|NCT00395161|O1|Outcome|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
366360|NCT00395161|E2|Reported Event|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
366361|NCT00395161|E1|Reported Event|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
366362|NCT00395226|B3|Baseline|Total|Total of all reporting groups
366363|NCT00395226|B2|Baseline|Zinc Sulfate|
366364|NCT00395226|B1|Baseline|Placebo (Lactose)|
366365|NCT00395226|P2|Participant Flow|Zinc Sulfate|
366366|NCT00395226|P1|Participant Flow|Placebo (Lactose)|
366367|NCT00395226|O2|Outcome|Zinc Sulfate|
366368|NCT00395226|O1|Outcome|Placebo (Lactose)|
366369|NCT00395226|E2|Reported Event|Zinc Sulfate|
366370|NCT00395226|E1|Reported Event|Placebo (Lactose)|
366372|NCT00395291|P2|Participant Flow|Placebo First, Then MK-0677|Subjects took Placebo for at least 30 days.
366373|NCT00395291|P1|Participant Flow|MK-0677 First, Then Placebo|Subjects took 25mg of MK-0677 for at least 30 Days.
366374|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366375|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366376|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366377|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366378|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366379|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366380|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366381|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366382|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366383|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366384|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366385|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366386|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366387|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366388|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366389|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366390|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366391|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366392|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366393|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366394|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366395|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366396|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366397|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366398|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
366399|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366400|NCT00395291|E2|Reported Event|Placebo|Subjects took Placebo for at least 30 days.
366401|NCT00395291|E1|Reported Event|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
366402|NCT00395304|B1|Baseline|All Participants|All participants randomized to the six crossover sequences
366403|NCT00395304|P6|Participant Flow|1xICS + LTRA, 1xICS + LABA, 2xICS|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
366404|NCT00395304|P5|Participant Flow|1xICS + LTRA, 2xICS, 1xICS + LABA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
366453|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366405|NCT00395304|P4|Participant Flow|1xICS + LABA, 1xICS + LTRA, 2xICS|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
366406|NCT00395304|P3|Participant Flow|1xICS +LABA, 2xICS, 1xICS + LTRA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
366407|NCT00395304|P2|Participant Flow|2xICS, 1xICS + LTRA, 1xICS + LABA|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
366408|NCT00395304|P1|Participant Flow|2xICS, 1xICS + LABA, 1xICS + LTRA|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
366409|NCT00395304|O1|Outcome|All Participants|All participants randomized to the six crossover sequences
366410|NCT00395304|E1|Reported Event|All Participants|All participants randomized to the six crossover sequences
366411|NCT00395343|B3|Baseline|Total|Total of all reporting groups
366412|NCT00395343|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366413|NCT00395343|B1|Baseline|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366414|NCT00395343|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366478|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366479|NCT00395486|O2|Outcome|Atorvastatin|10mg
366480|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366415|NCT00395343|P1|Participant Flow|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366416|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366417|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366418|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366419|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366420|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366421|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366422|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366423|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366424|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366454|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366425|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366426|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366427|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366428|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366429|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366430|NCT00395343|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366431|NCT00395343|E1|Reported Event|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
366432|NCT00395447|B3|Baseline|Total|Total of all reporting groups
366433|NCT00395447|B2|Baseline|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
366434|NCT00395447|B1|Baseline|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
366481|NCT00395486|O2|Outcome|Atorvastatin|10mg
366482|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366483|NCT00395486|O2|Outcome|Atorvastatin|10mg
366484|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366435|NCT00395447|P2|Participant Flow|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
366436|NCT00395447|P1|Participant Flow|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
366437|NCT00395447|O2|Outcome|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
366438|NCT00395447|O1|Outcome|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
366439|NCT00395447|E2|Reported Event|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
366440|NCT00395447|E1|Reported Event|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
366441|NCT00395460|B3|Baseline|Total|Total of all reporting groups
366442|NCT00395460|B2|Baseline|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366443|NCT00395460|B1|Baseline|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366444|NCT00395460|P2|Participant Flow|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366445|NCT00395460|P1|Participant Flow|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366446|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366447|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366448|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366449|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366450|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366451|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366452|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366455|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366456|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366457|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366458|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366459|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366460|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366461|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366462|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366463|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366464|NCT00395460|E2|Reported Event|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
366465|NCT00395460|E1|Reported Event|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
366466|NCT00395486|B3|Baseline|Total|Total of all reporting groups
366467|NCT00395486|B2|Baseline|Atorvastatin|10mg
366468|NCT00395486|B1|Baseline|Rosuvastatin|10mg
366469|NCT00395486|P2|Participant Flow|Atorvastatin|10mg
366470|NCT00395486|P1|Participant Flow|Rosuvastatin|10mg
366471|NCT00395486|O2|Outcome|Atorvastatin|10mg
366472|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366473|NCT00395486|O2|Outcome|Atorvastatin|10mg
366474|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366475|NCT00395486|O2|Outcome|Atorvastatin|10mg
366476|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366477|NCT00395486|O2|Outcome|Atorvastatin|10mg
366486|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366487|NCT00395486|O2|Outcome|Atorvastatin|10mg
366488|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366489|NCT00395486|O2|Outcome|Atorvastatin|10mg
366490|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366491|NCT00395486|O2|Outcome|Atorvastatin|10mg
366492|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366493|NCT00395486|O2|Outcome|Atorvastatin|10mg
366494|NCT00395486|O1|Outcome|Rosuvastatin|10mg
366495|NCT00395486|E2|Reported Event|Atorvastatin|10mg
366496|NCT00395486|E1|Reported Event|Rosuvastatin|10mg
366497|NCT00395512|B5|Baseline|Total|Total of all reporting groups
366498|NCT00395512|B4|Baseline|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366499|NCT00395512|B3|Baseline|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366500|NCT00395512|B2|Baseline|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366501|NCT00395512|B1|Baseline|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366502|NCT00395512|P4|Participant Flow|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366503|NCT00395512|P3|Participant Flow|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366504|NCT00395512|P2|Participant Flow|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366505|NCT00395512|P1|Participant Flow|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366506|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366507|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366508|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366509|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366510|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366511|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366512|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366513|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366514|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
371205|NCT00410813|O1|Outcome|BAP at Baseline|
366515|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366516|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366517|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366518|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366519|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366520|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366521|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366522|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366523|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366524|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366525|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366526|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366527|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366528|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366529|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366530|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366843|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
366531|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366532|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366533|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366534|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366535|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366536|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366537|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366538|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366539|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366540|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366541|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366542|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366543|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366544|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366545|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366546|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366547|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366548|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366549|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366550|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366551|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366552|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366553|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366554|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366555|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366556|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366557|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366558|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366559|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366560|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366561|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366562|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366563|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366564|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366565|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366566|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366567|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366568|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366844|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
366569|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366570|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366571|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366572|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366573|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366574|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366575|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366576|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366577|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366578|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366579|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366580|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366581|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366582|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366583|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366584|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366585|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366586|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366587|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366588|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366589|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366590|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366591|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366592|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366593|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366594|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366595|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366596|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366597|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366598|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366599|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366600|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366601|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366602|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366603|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366604|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366605|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366606|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366845|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
366607|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366608|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366609|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366610|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366611|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366612|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366613|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366614|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366615|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366616|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366617|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366618|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366619|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366620|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366621|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366622|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366623|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366624|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366625|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366626|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366627|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366628|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366629|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366630|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366631|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366632|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366633|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366634|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366635|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366636|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366637|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366638|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366639|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366640|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366641|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366642|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366643|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366644|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366846|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
366645|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366646|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366647|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366648|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366649|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366650|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366651|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366652|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366653|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366654|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366655|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366656|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366657|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366658|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366659|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366660|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366661|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366662|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366663|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366664|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366665|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366666|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366667|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366668|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366669|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366670|NCT00395512|E4|Reported Event|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366671|NCT00395512|E3|Reported Event|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
366672|NCT00395512|E2|Reported Event|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
366673|NCT00395512|E1|Reported Event|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
366674|NCT00395629|B4|Baseline|Total|Total of all reporting groups
366675|NCT00395629|B3|Baseline|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366676|NCT00395629|B2|Baseline|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366677|NCT00395629|B1|Baseline|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366678|NCT00395629|P3|Participant Flow|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366679|NCT00395629|P2|Participant Flow|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366680|NCT00395629|P1|Participant Flow|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366681|NCT00395629|O3|Outcome|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366682|NCT00395629|O2|Outcome|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366683|NCT00395629|O1|Outcome|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366684|NCT00395629|O3|Outcome|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366685|NCT00395629|O2|Outcome|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366686|NCT00395629|O1|Outcome|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366687|NCT00395629|E6|Reported Event|Deferasirox (ICL670) 15 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366688|NCT00395629|E5|Reported Event|Deferasirox (ICL670) 10 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366689|NCT00395629|E4|Reported Event|Deferasirox (ICL670) 5 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366690|NCT00395629|E3|Reported Event|Deferasirox (ICL670) 15 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366691|NCT00395629|E2|Reported Event|Deferasirox (ICL670) 10 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366692|NCT00395629|E1|Reported Event|Deferasirox (ICL670) 5 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
366693|NCT00395642|B1|Baseline|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
366694|NCT00395642|P1|Participant Flow|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
366695|NCT00395642|O1|Outcome|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
366696|NCT00395642|E1|Reported Event|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
366697|NCT00395694|B3|Baseline|Total|Total of all reporting groups
366810|NCT00395850|P4|Participant Flow|Disulfiram 500|Disulfiram at 500 mg/day
366698|NCT00395694|B2|Baseline|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366699|NCT00395694|B1|Baseline|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
366700|NCT00395694|P2|Participant Flow|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366701|NCT00395694|P1|Participant Flow|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
366780|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366702|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366703|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366704|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366705|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
366730|NCT00395694|E1|Reported Event|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
366731|NCT00395733|B3|Baseline|Total|Total of all reporting groups
366706|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366707|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366708|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366709|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366742|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366781|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366710|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
366711|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366712|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366713|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
366762|NCT00395746|P1|Participant Flow|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366714|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366715|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366716|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
366717|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366718|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366841|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
366719|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
366720|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366721|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366732|NCT00395733|B2|Baseline|Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol|Period 1: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
366808|NCT00395850|B2|Baseline|Disulfiram 250|disulfiram at 250 mg/day
366722|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366723|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366724|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
366725|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366726|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366743|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366744|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366842|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
366727|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
366728|NCT00395694|E3|Reported Event|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366729|NCT00395694|E2|Reported Event|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
366760|NCT00395746|P3|Participant Flow|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366733|NCT00395733|B1|Baseline|Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine|Period 1: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
366734|NCT00395733|P2|Participant Flow|Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol|Period 1: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadobutrol 0.2 - 0.3 mmol/kg BW (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
366735|NCT00395733|P1|Participant Flow|Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine|Period 1: Gadobutrol 0.2 - 0.3 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
366736|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366737|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366738|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366739|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366740|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366741|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366745|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366746|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366747|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366748|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366749|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366750|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366751|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366752|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366753|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366754|NCT00395733|E2|Reported Event|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366755|NCT00395733|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
366756|NCT00395746|B4|Baseline|Total|Total of all reporting groups
366757|NCT00395746|B3|Baseline|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366758|NCT00395746|B2|Baseline|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366759|NCT00395746|B1|Baseline|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366763|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366764|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366765|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366766|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366767|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366768|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366769|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366770|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366771|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366772|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366773|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366774|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366775|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366776|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366777|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366778|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366779|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366782|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366783|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366784|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366785|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366786|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366787|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366788|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366789|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366790|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366791|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366792|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366793|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366794|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366795|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366796|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366797|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366798|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366799|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366800|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366801|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366802|NCT00395746|E3|Reported Event|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366803|NCT00395746|E2|Reported Event|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366804|NCT00395746|E1|Reported Event|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
366805|NCT00395850|B5|Baseline|Total|Total of all reporting groups
366806|NCT00395850|B4|Baseline|Disulfiram 500|Disulfiram at 500 mg/day
366807|NCT00395850|B3|Baseline|Disulfiram 375|Disulfiram at 375 mg/day
366811|NCT00395850|P3|Participant Flow|Disulfiram 375|Disulfiram at 375 mg/day
366812|NCT00395850|P2|Participant Flow|Disulfiram 250|disulfiram at 250 mg/day
366813|NCT00395850|P1|Participant Flow|Placebo|microcrystalline cellulose
366814|NCT00395850|O4|Outcome|Disulfiram 500|Disulfiram at 500 mg/day
366815|NCT00395850|O3|Outcome|Disulfiram 375|Disulfiram at 375 mg/day
366816|NCT00395850|O2|Outcome|Disulfiram 250|disulfiram at 250 mg/day
366817|NCT00395850|O1|Outcome|Placebo|microcrystalline cellulose
366818|NCT00395850|O4|Outcome|Disulfiram 500|Disulfiram at 500 mg/day
366819|NCT00395850|O3|Outcome|Disulfiram 375|Disulfiram at 375 mg/day
366820|NCT00395850|O2|Outcome|Disulfiram 250|disulfiram at 250 mg/day
366821|NCT00395850|O1|Outcome|Placebo|microcrystalline cellulose
366822|NCT00395850|E4|Reported Event|Disulfiram 500|Disulfiram at 500 mg/day
366823|NCT00395850|E3|Reported Event|Disulfiram 375|Disulfiram at 375 mg/day
366824|NCT00395850|E2|Reported Event|Disulfiram 250|disulfiram at 250 mg/day
366825|NCT00395850|E1|Reported Event|Placebo|microcrystalline cellulose
366826|NCT00395863|B3|Baseline|Total|Total of all reporting groups
366827|NCT00395863|B2|Baseline|Magnevist, Then MultiHance|0.1 mmol/kg injection of each product
366828|NCT00395863|B1|Baseline|MultiHance, Then Magnevist|0.1 mmol/kg injection of each product
366829|NCT00395863|P2|Participant Flow|Magnevist, Then MultiHance|0.1 mmol/kg injection of each product
366830|NCT00395863|P1|Participant Flow|MultiHance, Then Magnevist|0.1 mmol/kg injection of each product
366831|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
366832|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
366833|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
366834|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
366835|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
366836|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
366837|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
366838|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
366839|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
366840|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
366847|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
366848|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
366849|NCT00395863|O3|Outcome|Reader 3|
366850|NCT00395863|O2|Outcome|Reader 2|
366851|NCT00395863|O1|Outcome|Reader 1|
366852|NCT00395863|O3|Outcome|Reader 3|
366853|NCT00395863|O2|Outcome|Reader 2|
366854|NCT00395863|O1|Outcome|Reader 1|
366855|NCT00395863|O3|Outcome|Reader 3|
366856|NCT00395863|O2|Outcome|Reader 2|
366857|NCT00395863|O1|Outcome|Reader 1|
366858|NCT00395863|E2|Reported Event|Magnevist|Adverse events experienced by patients occurred relative to the administration of Magnevist.
366859|NCT00395863|E1|Reported Event|MultiHance|Adverse events experienced by patients occurred relative to the administration of MultiHance.
366860|NCT00395876|B3|Baseline|Total|Total of all reporting groups
366861|NCT00395876|B2|Baseline|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366862|NCT00395876|B1|Baseline|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366863|NCT00395876|P2|Participant Flow|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366864|NCT00395876|P1|Participant Flow|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366902|NCT00395993|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
366903|NCT00395993|O2|Outcome|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
366904|NCT00395993|O1|Outcome|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
366865|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366866|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366867|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366868|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366889|NCT00395967|B1|Baseline|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
366977|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
366869|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366870|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366871|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366872|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366873|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366905|NCT00395993|E2|Reported Event|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
366906|NCT00395993|E1|Reported Event|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
366907|NCT00396006|B1|Baseline|Participants Treated With ARALAST Fr. IV-1|
366874|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366875|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366876|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366877|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366878|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366972|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366973|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
366879|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366880|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366881|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366882|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366883|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366884|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366885|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366886|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366887|NCT00395876|E2|Reported Event|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366888|NCT00395876|E1|Reported Event|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).
If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
366974|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
366975|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366890|NCT00395967|P1|Participant Flow|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
366891|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
366892|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
366893|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
366894|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
366895|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
366896|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
366897|NCT00395967|E1|Reported Event|All Patients|All patients (3 NHL, 1 MM, and 1 HD).
366898|NCT00395993|B3|Baseline|Total|Total of all reporting groups
366899|NCT00395993|B2|Baseline|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
366900|NCT00395993|B1|Baseline|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
366901|NCT00395993|P2|Participant Flow|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
371206|NCT00410813|O3|Outcome|NTx at 8 Weeks|
366908|NCT00396006|P1|Participant Flow|Participants Treated With ARALAST Fraction IV-1 (Fr. IV-1)|Weekly infusions of ARALAST Fr. IV-1 were administered to participants at a dosage of 60 mg/kg
366909|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
366910|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
366911|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
366912|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
366913|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
366914|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
366915|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
366916|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
366917|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
366918|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
366919|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
366920|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
366976|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366921|NCT00396006|E1|Reported Event|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
366922|NCT00396032|B3|Baseline|Total|Total of all reporting groups
366923|NCT00396032|B2|Baseline|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366924|NCT00396032|B1|Baseline|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366925|NCT00396032|P2|Participant Flow|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366926|NCT00396032|P1|Participant Flow|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366927|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366928|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366929|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366930|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366931|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366932|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366933|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366934|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366935|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366936|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366937|NCT00396032|E2|Reported Event|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366938|NCT00396032|E1|Reported Event|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
366939|NCT00396084|B7|Baseline|Total|Total of all reporting groups
366940|NCT00396084|B6|Baseline|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366941|NCT00396084|B5|Baseline|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
366942|NCT00396084|B4|Baseline|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
366943|NCT00396084|B3|Baseline|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
366944|NCT00396084|B2|Baseline|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
366945|NCT00396084|B1|Baseline|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
366946|NCT00396084|P6|Participant Flow|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366947|NCT00396084|P5|Participant Flow|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
366948|NCT00396084|P4|Participant Flow|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
366949|NCT00396084|P3|Participant Flow|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
366950|NCT00396084|P2|Participant Flow|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
366951|NCT00396084|P1|Participant Flow|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
366952|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
366953|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid 600 mg/day x 7 days
366954|NCT00396084|O1|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366955|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
366956|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
366957|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366958|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
366959|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
366960|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366961|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
366962|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
366963|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366964|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
366965|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
366966|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366967|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
366968|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
366969|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366970|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
366971|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
366978|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7 days
366979|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
366980|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366981|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
366982|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
366983|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
366984|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
366985|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
366986|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366987|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366988|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
366989|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7 days
366990|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
366991|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366992|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
366993|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
366994|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
366995|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
366996|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
366997|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
366998|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
366999|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
367000|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
367001|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
367002|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
367003|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
367004|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
367005|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
367006|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
367007|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
367008|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
367009|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
367010|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
367011|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
367012|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
367013|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
367014|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
367015|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
367016|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
367017|NCT00396084|E6|Reported Event|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
367018|NCT00396084|E5|Reported Event|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
367019|NCT00396084|E4|Reported Event|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
367020|NCT00396084|E3|Reported Event|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
367021|NCT00396084|E2|Reported Event|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
367022|NCT00396084|E1|Reported Event|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
367023|NCT00396097|B3|Baseline|Total|Total of all reporting groups
367024|NCT00396097|B2|Baseline|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
367025|NCT00396097|B1|Baseline|Standard Dose Arm|The participants received subcutaneous genotropin daily, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
367026|NCT00396097|P2|Participant Flow|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
367027|NCT00396097|P1|Participant Flow|Standard Dose Arm|The participants received subcutaneous genotropin, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
367028|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
367029|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
367056|NCT00396162|P2|Participant Flow|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
367057|NCT00396162|P1|Participant Flow|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
367058|NCT00396162|O2|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
367030|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
367031|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
367032|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24/mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
367033|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
367034|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
367035|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
367036|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
367037|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
367038|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
367039|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
367040|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
367041|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
367042|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
367043|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
367044|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
367045|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
367046|NCT00396097|E2|Reported Event|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
367047|NCT00396097|E1|Reported Event|Standard Dose Arm|The participants received subcutaneous genotropin daily, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
367048|NCT00396136|B1|Baseline|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
367049|NCT00396136|P1|Participant Flow|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
367050|NCT00396136|O1|Outcome|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
367051|NCT00396136|O1|Outcome|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
367052|NCT00396136|E1|Reported Event|Group 1|
367053|NCT00396162|B3|Baseline|Total|Total of all reporting groups
367054|NCT00396162|B2|Baseline|Placebo Pill|"Placebo pills on same schedule as active intervention.
probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
367055|NCT00396162|B1|Baseline|Probiotic|"drug
probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
367059|NCT00396162|O1|Outcome|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
367060|NCT00396162|O2|Outcome|Active Intervention|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
367061|NCT00396162|O1|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
367062|NCT00396162|O2|Outcome|Probiotic|"L. rhamnosus R0011 strain
probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
367063|NCT00396162|O1|Outcome|Placebo Pill|"Placebo pills on same schedule as active intervention.
Placebo: Placebo pill"
367064|NCT00396162|O2|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
367065|NCT00396162|O1|Outcome|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
367066|NCT00396162|E2|Reported Event|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
367067|NCT00396162|E1|Reported Event|Active Intervention|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
367068|NCT00396201|B1|Baseline|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367069|NCT00396201|P1|Participant Flow|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin's disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with granulocyte-colony stimulating factor (G-CSF) [10 µg/kg each day (QD)] and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367070|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367071|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367220|NCT00396409|P1|Participant Flow|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367362|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
367072|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367073|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367074|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367075|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367076|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367077|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367078|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367452|NCT00397189|P2|Participant Flow|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
367079|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367080|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367081|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367082|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367083|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367084|NCT00396201|E1|Reported Event|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
367085|NCT00396253|B1|Baseline|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367086|NCT00396253|P1|Participant Flow|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367221|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367222|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367087|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367088|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367089|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367090|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367091|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367092|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367390|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367093|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367094|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367095|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367096|NCT00396253|E1|Reported Event|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
367097|NCT00396266|B3|Baseline|Total|Total of all reporting groups
367098|NCT00396266|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367099|NCT00396266|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367100|NCT00396266|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367274|NCT00396565|E3|Reported Event|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
367101|NCT00396266|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367102|NCT00396266|O1|Outcome|PD Subgroup|Subgroup of 4 patients (3 MM and 1 NHL) for which a pharmacodynamic (PD) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
367103|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
367104|NCT00396266|O3|Outcome|Total|All patients.
367105|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367106|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367107|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
367108|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
367109|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
367110|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
367111|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
367391|NCT00397033|O1|Outcome|Placebo|
368138|NCT00406107|P1|Participant Flow|Pegaptanib Sodium 0.3mg (Macugen)|
367112|NCT00396266|O1|Outcome|Non-hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367113|NCT00396266|O3|Outcome|Total|All patients.
367114|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367115|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367116|NCT00396266|O3|Outcome|Total|All patients.
367117|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367118|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367119|NCT00396266|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367120|NCT00396266|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
367121|NCT00396279|B1|Baseline|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
367122|NCT00396279|P1|Participant Flow|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
367123|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
367124|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
367125|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
367126|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
367127|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
367128|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
367453|NCT00397189|P1|Participant Flow|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
367129|NCT00396279|E1|Reported Event|Denosumab 120 mg Q4W|Participants received a dose loading regimen of 3 subcutaneous injections of denosumab 120 mg every week for 3 weeks (study Days 1, 8, and 15), followed by a week of rest, and then 120 mg denosumab once every 4 weeks (Q4W) from Day 29.
367130|NCT00396292|B3|Baseline|Total|Total of all reporting groups
367131|NCT00396292|B2|Baseline|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
367132|NCT00396292|B1|Baseline|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
367133|NCT00396292|P2|Participant Flow|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
367134|NCT00396292|P1|Participant Flow|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
367135|NCT00396292|O2|Outcome|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
367136|NCT00396292|O1|Outcome|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
367137|NCT00396292|E2|Reported Event|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
367138|NCT00396292|E1|Reported Event|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
367139|NCT00396318|B1|Baseline|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
367159|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367424|NCT00397033|O1|Outcome|Placebo|
367140|NCT00396318|P1|Participant Flow|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
367141|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
367142|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
367143|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
367241|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367392|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367144|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
367145|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
367146|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
367275|NCT00396565|E2|Reported Event|Placebo|Two placebo tablets once daily for 6 weeks
367147|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
367148|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
367149|NCT00396318|E1|Reported Event|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
367150|NCT00396331|B5|Baseline|Total|Total of all reporting groups
367151|NCT00396331|B4|Baseline|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367152|NCT00396331|B3|Baseline|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367242|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367243|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367153|NCT00396331|B2|Baseline|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367154|NCT00396331|B1|Baseline|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367155|NCT00396331|P1|Participant Flow|G-CSF Plus Plerixafor|Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367156|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367157|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367158|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367356|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
367160|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367161|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367162|NCT00396331|O5|Outcome|All Patients|
367163|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367164|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367165|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367166|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367167|NCT00396331|O5|Outcome|All Patients|
367168|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367169|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367170|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367171|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367172|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367173|NCT00396331|O5|Outcome|All Patients|
367174|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367175|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367176|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367177|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367178|NCT00396331|O5|Outcome|All Patients|
367179|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367180|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367181|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367182|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367183|NCT00396331|O5|Outcome|All Patients|
367184|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367185|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367186|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367187|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367188|NCT00396331|O5|Outcome|All Patients|
367646|NCT00404547|E2|Reported Event|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
367189|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367190|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367191|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367192|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367193|NCT00396331|O5|Outcome|All Patients|
367194|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367195|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367196|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367197|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367198|NCT00396331|O5|Outcome|All Patients|
367199|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367200|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367201|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367202|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367203|NCT00396331|E4|Reported Event|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367204|NCT00396331|E3|Reported Event|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367205|NCT00396331|E2|Reported Event|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367244|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367206|NCT00396331|E1|Reported Event|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
367207|NCT00396383|B1|Baseline|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
367208|NCT00396383|P1|Participant Flow|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
367209|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
367210|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
367211|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
367212|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
367213|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
367214|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
367215|NCT00396383|E1|Reported Event|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
367216|NCT00396409|B3|Baseline|Total|Total of all reporting groups
367217|NCT00396409|B2|Baseline|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367218|NCT00396409|B1|Baseline|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367219|NCT00396409|P2|Participant Flow|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367223|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367224|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367225|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367226|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367227|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367228|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367229|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367230|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367231|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367232|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367233|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367234|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367235|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367236|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367237|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367238|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367239|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367240|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367647|NCT00404547|E1|Reported Event|Alvesco|320 mcg/day or 640 mcg/day
367245|NCT00396409|E4|Reported Event|Depigoid + Placebo 2008|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367246|NCT00396409|E3|Reported Event|Depigoid + Placebo 2007|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
367247|NCT00396409|E2|Reported Event|Depigoid + Omalizumab 2008|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367248|NCT00396409|E1|Reported Event|Depigoid + Omalizumab 2007|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
367249|NCT00396565|B4|Baseline|Total|Total of all reporting groups
367250|NCT00396565|B3|Baseline|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
367251|NCT00396565|B2|Baseline|Placebo|Two placebo tablets once daily for 6 weeks
367252|NCT00396565|B1|Baseline|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
367253|NCT00396565|P3|Participant Flow|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
367254|NCT00396565|P2|Participant Flow|Placebo|Two placebo tablets once daily for 6 weeks
367255|NCT00396565|P1|Participant Flow|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
367256|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
367257|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
367258|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
367259|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
367260|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
367261|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
367262|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
367263|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
367264|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
367265|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
367266|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
367267|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
367268|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
367269|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
367270|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
367271|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
367272|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
367273|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
367276|NCT00396565|E1|Reported Event|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
367277|NCT00396591|B1|Baseline|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
367278|NCT00396591|P1|Participant Flow|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
367279|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
367280|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
367281|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
367282|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
367283|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
367284|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
367285|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
367286|NCT00396591|E1|Reported Event|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
367287|NCT00396630|B3|Baseline|Total|Total of all reporting groups
367288|NCT00396630|B2|Baseline|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367289|NCT00396630|B1|Baseline|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367290|NCT00396630|P2|Participant Flow|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367387|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367291|NCT00396630|P1|Participant Flow|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367292|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367293|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367294|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367295|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367296|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367297|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367298|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367299|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367300|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367301|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367302|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367303|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367304|NCT00396630|O1|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367305|NCT00396630|E2|Reported Event|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367357|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
367358|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
367306|NCT00396630|E1|Reported Event|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
367307|NCT00396656|B1|Baseline|Entire Study Population|Includes patients that received valsartan followed by atenolol + hydrochlorothiazide and patients that received atenolol + hydrochlorothiazide followed by valsartan.
367308|NCT00396656|P2|Participant Flow|Atenolol + Hydrochlorothiazide (HCTZ) Followed by Valsartan|"After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.
After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning"
367309|NCT00396656|P1|Participant Flow|Valsartan Followed by Atenolol + Hydrochlorothiazide (HCTZ)|"After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning."
367310|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
367311|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
367312|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
367388|NCT00397033|O1|Outcome|Placebo|
367313|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
367314|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
367315|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
367316|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
367317|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
367318|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
367319|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
367320|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
367321|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
367359|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
367360|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
367361|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
367322|NCT00396656|E2|Reported Event|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
367323|NCT00396656|E1|Reported Event|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
367324|NCT00396812|B1|Baseline|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
367325|NCT00396812|P1|Participant Flow|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
367326|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
367327|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
367328|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
367329|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
367330|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
367331|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
367332|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
367389|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367333|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
367334|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
367335|NCT00396812|E1|Reported Event|Rituximab|Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2. Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid.
367336|NCT00396877|B3|Baseline|Total|Total of all reporting groups
367337|NCT00396877|B2|Baseline|Clopidogrel 0.2 mg/kg/Day|
367338|NCT00396877|B1|Baseline|Placebo|
367339|NCT00396877|P2|Participant Flow|Clopidogrel 0.2 mg/kg/Day|"Reconstituted solution using Clopidogrel powder administered once daily with a graduated syringe in the mouth or via a feeding tube.
Route: oral or enteric
Frequency: once daily
Dose: daily dose adjusted for weight"
367340|NCT00396877|P1|Participant Flow|Placebo|Reconstituted solution using Clopidogrel matching placebo powder administered once daily with a graduated syringe in the mouth or via a feeding tube.
367341|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
367342|NCT00396877|O1|Outcome|Placebo|
367343|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
367344|NCT00396877|O1|Outcome|Placebo|
367345|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
367346|NCT00396877|O1|Outcome|Placebo|
367347|NCT00396877|E2|Reported Event|Clopidogrel 0.2mg/kg/Day|
367348|NCT00396877|E1|Reported Event|Placebo|
367349|NCT00396981|B3|Baseline|Total|Total of all reporting groups
367350|NCT00396981|B2|Baseline|GDC® Coils for Endovascular Aneurysm Occlusion|"GDC® Coils for endovascular aneurysm occlusion
GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
367351|NCT00396981|B1|Baseline|Matrix 2® Coils for Endovascular Aneurysm Occlusion|"Matrix 2® Coils for endovascular aneurysm occlusion
Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
367352|NCT00396981|P2|Participant Flow|GDC® Coils for Endovascular Aneurysm Occlusion|"GDC® Coils for endovascular aneurysm occlusion
GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
367353|NCT00396981|P1|Participant Flow|Matrix 2® Coils for Endovascular Aneurysm Occlusion|"Matrix 2® Coils for endovascular aneurysm occlusion
Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
367354|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
367355|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
371207|NCT00410813|O2|Outcome|NTx at 4 Weeks|
367363|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
367364|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
367365|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
367366|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
367367|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
367368|NCT00396981|E2|Reported Event|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
367369|NCT00396981|E1|Reported Event|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
367370|NCT00397033|B4|Baseline|Total|Total of all reporting groups
367371|NCT00397033|B3|Baseline|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367372|NCT00397033|B2|Baseline|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367373|NCT00397033|B1|Baseline|Placebo|
367374|NCT00397033|P3|Participant Flow|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367375|NCT00397033|P2|Participant Flow|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367376|NCT00397033|P1|Participant Flow|Placebo|
367377|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367378|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367379|NCT00397033|O1|Outcome|Placebo|
367380|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367381|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367382|NCT00397033|O1|Outcome|Placebo|
367383|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367384|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367385|NCT00397033|O1|Outcome|Placebo|
367386|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367393|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367394|NCT00397033|O1|Outcome|Placebo|
367395|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367396|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367397|NCT00397033|O1|Outcome|Placebo|
367398|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367399|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367400|NCT00397033|O1|Outcome|Placebo|
367401|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367402|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367403|NCT00397033|O1|Outcome|Placebo|
367404|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367405|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367406|NCT00397033|O1|Outcome|Placebo|
367407|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367408|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367409|NCT00397033|O1|Outcome|Placebo|
367410|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367411|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367412|NCT00397033|O1|Outcome|Placebo|
367413|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367414|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367415|NCT00397033|O1|Outcome|Placebo|
367416|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367417|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367418|NCT00397033|O1|Outcome|Placebo|
367419|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367420|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367421|NCT00397033|O1|Outcome|Placebo|
367422|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367423|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367425|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367426|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367427|NCT00397033|O1|Outcome|Placebo|
367428|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367429|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367430|NCT00397033|O1|Outcome|Placebo|
367431|NCT00397033|E3|Reported Event|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
367432|NCT00397033|E2|Reported Event|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
367433|NCT00397033|E1|Reported Event|Placebo|
367434|NCT00397150|B3|Baseline|Total|Total of all reporting groups
367435|NCT00397150|B2|Baseline|No Intervention|Standard of care
367436|NCT00397150|B1|Baseline|Intervention|Peer-counselling for exclusive breastfeeding
367437|NCT00397150|P2|Participant Flow|No Intervention|Standard of care
367438|NCT00397150|P1|Participant Flow|Intervention|Peer-counselling for exclusive breastfeeding
367439|NCT00397150|O2|Outcome|No Intervention|Standard of care
367440|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
367441|NCT00397150|O2|Outcome|No Intervention|Standard of care
367442|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
367443|NCT00397150|O2|Outcome|No Intervention|Standard of care
367444|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
367445|NCT00397150|O2|Outcome|No Intervention|Standard of care
367446|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
367447|NCT00397150|E2|Reported Event|Standard of Care|
367448|NCT00397150|E1|Reported Event|Peer Counselling for Exclusive Breastfeeding|
367449|NCT00397189|B3|Baseline|Total|Total of all reporting groups
367450|NCT00397189|B2|Baseline|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
367451|NCT00397189|B1|Baseline|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
367454|NCT00397189|O2|Outcome|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
367455|NCT00397189|O1|Outcome|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
367456|NCT00397189|E2|Reported Event|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
367457|NCT00397189|E1|Reported Event|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
367458|NCT00397215|B5|Baseline|Total|Total of all reporting groups
367459|NCT00397215|B4|Baseline|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367460|NCT00397215|B3|Baseline|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367461|NCT00397215|B2|Baseline|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367462|NCT00397215|B1|Baseline|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367463|NCT00397215|P4|Participant Flow|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367464|NCT00397215|P3|Participant Flow|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367465|NCT00397215|P2|Participant Flow|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367466|NCT00397215|P1|Participant Flow|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367467|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367468|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367469|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367470|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367471|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367472|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367473|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367474|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367475|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367476|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367477|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367478|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367479|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367480|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367481|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367482|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367483|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367648|NCT00404651|B5|Baseline|Total|Total of all reporting groups
367484|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367485|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367486|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367487|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367488|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367489|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367490|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367491|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367492|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367493|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367494|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367495|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367496|NCT00397215|O3|Outcome|GSK1562902A 3 Group|GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367497|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367498|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367499|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367779|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
367500|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367501|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367502|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367503|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367504|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367505|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367506|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367507|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367508|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367509|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367510|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367696|NCT00405509|E2|Reported Event|Unconfirmed Respiratory Infection|
367697|NCT00405509|E1|Reported Event|Confirmed Respiratory Virus|
367511|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367512|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367513|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367514|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367515|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367516|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367517|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367518|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367519|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367520|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367521|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367522|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367523|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367524|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367525|NCT00397215|O2|Outcome|GSK1562902A 2 Group|GSK1562902A 2 Group Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367526|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367527|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367528|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367529|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367530|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367531|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367532|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367533|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367534|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367535|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367536|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367537|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367698|NCT00405548|B3|Baseline|Total|Total of all reporting groups
367699|NCT00405548|B2|Baseline|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
367538|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367539|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367540|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367541|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367542|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367543|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367544|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367545|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367546|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367547|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367548|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367549|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367550|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367551|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367552|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367553|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367554|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367555|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367556|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367557|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367558|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367559|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367560|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367561|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367562|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367563|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367564|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367700|NCT00405548|B1|Baseline|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
369461|NCT00400946|O3|Outcome|CNS-3|CNS-3: more than 5 WBC on CSF cell count, with blasts on cytospin
367565|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367566|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367567|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367568|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367569|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367570|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367571|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367572|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367573|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367574|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367575|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367576|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367577|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367578|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367579|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367580|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367581|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367582|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367583|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367584|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367585|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367586|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367587|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367588|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367589|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367590|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367591|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367592|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367593|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367594|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367595|NCT00397215|E4|Reported Event|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367596|NCT00397215|E3|Reported Event|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
367597|NCT00397215|E2|Reported Event|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367598|NCT00397215|E1|Reported Event|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
367599|NCT00397254|B1|Baseline|Baseline Period - Rizatriptan 9 Tablets|Prior to randomization at Visit 2 (to rizatriptan 9 tablets or rizatriptan 27 tablets), all subjects in Baseline were provided with 9 tablets of rizatriptan.
367600|NCT00397254|P2|Participant Flow|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
367601|NCT00397254|P1|Participant Flow|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
367602|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
367603|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
367604|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
367605|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
367606|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
367817|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
367607|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
367608|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
367609|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
367610|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
367611|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
367612|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
367613|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
367614|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
367615|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
367616|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
367701|NCT00405548|P2|Participant Flow|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
371180|NCT00410813|B3|Baseline|Total|Total of all reporting groups
367617|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
367618|NCT00404495|B3|Baseline|Total|Total of all reporting groups
367619|NCT00404495|B2|Baseline|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
367620|NCT00404495|B1|Baseline|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
367621|NCT00404495|P2|Participant Flow|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
367622|NCT00404495|P1|Participant Flow|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
367623|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
367624|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
367625|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
367626|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
367627|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
367628|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
367718|NCT00405587|P4|Participant Flow|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
367629|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
367630|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
367631|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
367632|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
367633|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
367634|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
367635|NCT00404495|E2|Reported Event|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
367636|NCT00404495|E1|Reported Event|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
367637|NCT00404547|B3|Baseline|Total|Total of all reporting groups
367638|NCT00404547|B2|Baseline|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
367639|NCT00404547|B1|Baseline|Alvesco|320 mcg/day or 640 mcg/day
367640|NCT00404547|P2|Participant Flow|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
367641|NCT00404547|P1|Participant Flow|Alvesco|320 mcg/day or 640 mcg/day
367642|NCT00404547|O2|Outcome|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
367643|NCT00404547|O1|Outcome|Alvesco|320 mcg/day or 640 mcg/day
367644|NCT00404547|O2|Outcome|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
367645|NCT00404547|O1|Outcome|Alvesco|320 mcg/day or 640 mcg/day
371350|NCT00405288|B3|Baseline|Total|Total of all reporting groups
367649|NCT00404651|B4|Baseline|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
367650|NCT00404651|B3|Baseline|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367651|NCT00404651|B2|Baseline|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367652|NCT00404651|B1|Baseline|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
367653|NCT00404651|P4|Participant Flow|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
367654|NCT00404651|P3|Participant Flow|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367655|NCT00404651|P2|Participant Flow|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367656|NCT00404651|P1|Participant Flow|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
367657|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
367777|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation – 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
367658|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367659|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367660|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
367661|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
367662|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367663|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367664|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
367665|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
367666|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367667|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367668|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
367669|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
367670|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367671|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367672|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
367673|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
367674|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367675|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367676|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
367677|NCT00404651|E4|Reported Event|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
367678|NCT00404651|E3|Reported Event|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367679|NCT00404651|E2|Reported Event|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
367680|NCT00404651|E1|Reported Event|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
367681|NCT00405509|B3|Baseline|Total|Total of all reporting groups
367682|NCT00405509|B2|Baseline|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
367683|NCT00405509|B1|Baseline|Confirmed Respiratory Infection|participants who had the type of viral infection confirmed by assay
367684|NCT00405509|P2|Participant Flow|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
367685|NCT00405509|P1|Participant Flow|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
367686|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
367687|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
367688|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
367689|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
367690|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
367691|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
367692|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
367693|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
367694|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
367695|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
367702|NCT00405548|P1|Participant Flow|BNP (Nesiritide)|Brain Natriuretic Peptide (BNP) 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
367703|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
367704|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
367705|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
367706|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
367707|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
367708|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
367709|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
367710|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
367711|NCT00405548|E2|Reported Event|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
367712|NCT00405548|E1|Reported Event|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
367713|NCT00405587|B5|Baseline|Total|Total of all reporting groups
367714|NCT00405587|B4|Baseline|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
367715|NCT00405587|B3|Baseline|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
367716|NCT00405587|B2|Baseline|Dose Escalation: MBP Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules/tablets in MBP formulation at a starting dose of 160 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 MBP formulation for 4 weeks. Dose escalation was continued up to unacceptable toxicity or disease progression occurred.
367717|NCT00405587|B1|Baseline|Dose Escalation: Original Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules in original (crystalline) formulation at a starting dose of 200 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 original formulation for 4 weeks. Dose escalation was continued up to 1600 mg BID dose level.
367778|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation – 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
367719|NCT00405587|P3|Participant Flow|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
367720|NCT00405587|P2|Participant Flow|Dose Escalation: MBP Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules/tablets in MBP formulation at a starting dose of 160 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 MBP formulation for 4 weeks. Dose escalation was continued up to unacceptable toxicity or disease progression occurred.
367721|NCT00405587|P1|Participant Flow|Dose Escalation: Original Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules in original (crystalline) formulation at a starting dose of 200 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 original formulation for 4 weeks. Dose escalation was continued up to 1600 mg BID dose level.
367722|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation and Extension: BRAFV600E- Pos|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules in MBP formulation at a dose of 960 mg BID , or 960 mg BID dose escalation
367723|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 80 mg Capsule|Participants received RO5185426 capsules in MBP formulation at a dose of 320 mg BID dose escalation/paired biopsy cohort, or 720 mg BID dose escalation/paired biopsy cohort, or 1120 mg BID dose escalation for 4 weeks.
367724|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation and Extension: BRAFV600E- Pos|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules in MBP formulation at a dose of 960 mg BID , or 960 mg BID dose escalation
367725|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 80 mg Capsule|Participants received RO5185426 capsules in MBP formulation at a dose of 320 mg BID dose escalation/paired biopsy cohort, or 720 mg BID dose escalation/paired biopsy cohort, or 1120 mg BID dose escalation for 4 weeks.
367726|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367727|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367728|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367757|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation – 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
369462|NCT00400946|O2|Outcome|CNS-2|CNS-2: 5 or fewer WBC on CSF cell count, with blasts on cytospin
367729|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367730|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367731|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367732|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation –1120 mg|Participants received RO5185426 hard gelatin capsules at a dose of 1120 mg BID for 4 weeks.
367733|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation –720 mg|Participants received RO5185426 hard gelatin capsules at a dose of 720 mg BID for 4 weeks.
367734|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation –360 mg|Participants received RO5185426 hard gelatin capsules at a dose of 360 mg BID for 4 weeks.
367735|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation –320 mg|Participants received RO5185426 hard gelatin capsules at a dose of 320 mg BID for 4 weeks.
367736|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation –240 mg|Participants received RO5185426 hard gelatin capsules at a dose of 240 mg BID for 4 weeks.
367737|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation –160 mg|Participants received RO5185426 hard gelatin capsules at a dose of 160 mg BID for 4 weeks.
367738|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
367739|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
367740|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
367741|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
367742|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367743|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367744|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367745|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367746|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367747|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367748|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367749|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367750|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367751|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367752|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367753|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367754|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367755|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367756|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
367758|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation – 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
367759|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation – 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
367760|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation – 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
367761|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
367762|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
367763|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation – 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
367764|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation – 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
367765|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation – 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
367766|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation – 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
367767|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
367768|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
367769|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation – 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
367770|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation – 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
367771|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation – 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
367772|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation – 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
367773|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
367774|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
367775|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation – 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
367776|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation – 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
367856|NCT00405704|B3|Baseline|Total|Total of all reporting groups
367780|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367781|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367782|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
367783|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation - 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
367784|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation - 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
367785|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation - 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
367786|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation - 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
367787|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation - 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
367788|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
367789|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation - 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
367790|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation - 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
367791|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation - 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
367792|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation - 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
367793|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation - 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
367794|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
367795|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation - 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
367796|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation - 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
367797|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation - 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
367798|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation - 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
367799|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation - 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
367800|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
367801|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
367802|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
367803|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
367804|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
367805|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
367806|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
367807|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
367808|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
367809|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
367810|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
367811|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
367812|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
367813|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
367814|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
367815|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
367816|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
367857|NCT00405704|B2|Baseline|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
367818|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
367819|NCT00405587|O1|Outcome|Dose Escalation Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
367820|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
367821|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
367822|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
367823|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
367824|NCT00405587|E12|Reported Event|Extension: BRAFV600E-Positive CRC|Participants with CRC that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185246 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367825|NCT00405587|E11|Reported Event|Extension: BRAFV600E-Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185246 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
367826|NCT00405587|E10|Reported Event|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
367827|NCT00405587|E9|Reported Event|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
367828|NCT00405587|E8|Reported Event|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
367829|NCT00405587|E7|Reported Event|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
367830|NCT00405587|E6|Reported Event|Dose Escalation: MBP Formulation - 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
367831|NCT00405587|E5|Reported Event|Dose Escalation: MBP Formulation - 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
367832|NCT00405587|E4|Reported Event|Dose Escalation: MBP Formulation - 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
367833|NCT00405587|E3|Reported Event|Dose Escalation: MBP Formulation - 320 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 320 mg BID for 4 weeks.
367834|NCT00405587|E2|Reported Event|Dose Escalation: MBP Formulation - 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
367835|NCT00405587|E1|Reported Event|Dose Escalation: MBP Formulation - 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
367836|NCT00405639|B3|Baseline|Total|Total of all reporting groups
367837|NCT00405639|B2|Baseline|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367838|NCT00405639|B1|Baseline|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367839|NCT00405639|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367840|NCT00405639|P1|Participant Flow|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367841|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367858|NCT00405704|B1|Baseline|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
367859|NCT00405704|P2|Participant Flow|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
369754|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
367842|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367843|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367844|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367845|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367846|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367847|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367878|NCT00405704|E1|Reported Event|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
367848|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367849|NCT00405639|E2|Reported Event|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367850|NCT00405639|E1|Reported Event|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
367851|NCT00405652|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
367852|NCT00405652|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
367853|NCT00405652|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
367854|NCT00405652|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
367855|NCT00405652|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
367860|NCT00405704|P1|Participant Flow|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
367861|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
367862|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
367863|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
367864|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
367865|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
367866|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
367867|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
367868|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
367869|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
367870|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
367871|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
367872|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
367873|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
367874|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
367875|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
367876|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
367877|NCT00405704|E2|Reported Event|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
367879|NCT00405756|B4|Baseline|Total|Total of all reporting groups
367880|NCT00405756|B3|Baseline|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367881|NCT00405756|B2|Baseline|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367882|NCT00405756|B1|Baseline|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367883|NCT00405756|P3|Participant Flow|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367884|NCT00405756|P2|Participant Flow|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367885|NCT00405756|P1|Participant Flow|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367886|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367887|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367888|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367889|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367890|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367984|NCT00405821|E1|Reported Event|Acyclovir 400mg Tablet Twice Daily|
367985|NCT00405912|B4|Baseline|Total|Total of all reporting groups
369755|NCT00401752|E2|Reported Event|Ranitidine|ranitidine 150 mg capsule bid oral administration
367891|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367892|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367893|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367894|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367895|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367896|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367897|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367898|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367899|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367900|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
368036|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
367901|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367902|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367903|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367904|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367905|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367906|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367907|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367908|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367909|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367910|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367911|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367912|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367913|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367914|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367915|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367916|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367917|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367918|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367919|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367920|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367921|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367999|NCT00405912|E2|Reported Event|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
367922|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367923|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367924|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367925|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367926|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367927|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367928|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367929|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367930|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367931|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367932|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367933|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367934|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367935|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367936|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367937|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367938|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367939|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367940|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367941|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367942|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
368033|NCT00406029|P1|Participant Flow|Preladenant 1 mg BID|Participants received preladenant 1 mg twice daily (BID) during the 12-week treatment period.
367943|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367944|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367945|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367946|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367947|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367948|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367949|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367950|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367951|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367952|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367953|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367954|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367955|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367956|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367957|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367958|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367959|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367960|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367961|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367962|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367963|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
368034|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
367964|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367965|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367966|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367967|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367968|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367969|NCT00405756|E3|Reported Event|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367970|NCT00405756|E2|Reported Event|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367971|NCT00405756|E1|Reported Event|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
367972|NCT00405821|B3|Baseline|Total|Total of all reporting groups
367973|NCT00405821|B2|Baseline|Placebo Tablet Twice Daily|
367974|NCT00405821|B1|Baseline|Acyclovir 400mg Tablet Twice Daily|
367975|NCT00405821|P2|Participant Flow|Placebo Tablet Twice Daily|
367976|NCT00405821|P1|Participant Flow|Acyclovir 400mg Tablet Twice Daily|
367977|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
367978|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
367979|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
367980|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
367981|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
367982|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
367983|NCT00405821|E2|Reported Event|Placebo Tablet Twice Daily|
367986|NCT00405912|B3|Baseline|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
367987|NCT00405912|B2|Baseline|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
367988|NCT00405912|B1|Baseline|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
367989|NCT00405912|P3|Participant Flow|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
367990|NCT00405912|P2|Participant Flow|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
367991|NCT00405912|P1|Participant Flow|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
367992|NCT00405912|O3|Outcome|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
367993|NCT00405912|O2|Outcome|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
367994|NCT00405912|O1|Outcome|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
367995|NCT00405912|O3|Outcome|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
367996|NCT00405912|O2|Outcome|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
367997|NCT00405912|O1|Outcome|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
367998|NCT00405912|E3|Reported Event|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
368035|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368000|NCT00405912|E1|Reported Event|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
368001|NCT00405938|B3|Baseline|Total|Total of all reporting groups
368002|NCT00405938|B2|Baseline|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
368003|NCT00405938|B1|Baseline|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
368004|NCT00405938|P2|Participant Flow|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
368005|NCT00405938|P1|Participant Flow|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
368006|NCT00405938|O2|Outcome|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
368007|NCT00405938|O1|Outcome|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
368008|NCT00405938|E2|Reported Event|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
368009|NCT00405938|E1|Reported Event|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
368010|NCT00405964|B3|Baseline|Total|Total of all reporting groups
368011|NCT00405964|B2|Baseline|Placebo Tablet|Matching placebo, orally daily.
368012|NCT00405964|B1|Baseline|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
368013|NCT00405964|P2|Participant Flow|Placebo Tablet|Matching placebo, orally daily.
368014|NCT00405964|P1|Participant Flow|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
368015|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
368016|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
368017|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
368018|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
368019|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
368020|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
368021|NCT00405964|E2|Reported Event|Placebo Tablet|Matching placebo, orally daily.
368022|NCT00405964|E1|Reported Event|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
368023|NCT00406029|B6|Baseline|Total|Total of all reporting groups
368024|NCT00406029|B5|Baseline|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368025|NCT00406029|B4|Baseline|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368026|NCT00406029|B3|Baseline|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368027|NCT00406029|B2|Baseline|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368028|NCT00406029|B1|Baseline|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368029|NCT00406029|P5|Participant Flow|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368030|NCT00406029|P4|Participant Flow|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368031|NCT00406029|P3|Participant Flow|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368032|NCT00406029|P2|Participant Flow|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368037|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368038|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368039|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368040|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368041|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368042|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368043|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368044|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368045|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368046|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368047|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368048|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368049|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368050|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368051|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368052|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368053|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368054|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368055|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368056|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368057|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368058|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368059|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368060|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368061|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368062|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368063|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368064|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368065|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368066|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368067|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368068|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368069|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368070|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368071|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368072|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368073|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368074|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368075|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368076|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368077|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368078|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368079|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368080|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368081|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368082|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368083|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368084|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368085|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368086|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368087|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368088|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368089|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368090|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368091|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368092|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368093|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368094|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368095|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368096|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368097|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368098|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368099|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368100|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368101|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368102|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368103|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368104|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368105|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368106|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368107|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368108|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368109|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368110|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368111|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368112|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368113|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368114|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368115|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368116|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368117|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368118|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368119|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368120|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368121|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368122|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368123|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368124|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368125|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368126|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368127|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368128|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368129|NCT00406029|E5|Reported Event|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
368130|NCT00406029|E4|Reported Event|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
368131|NCT00406029|E3|Reported Event|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
368132|NCT00406029|E2|Reported Event|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
368133|NCT00406029|E1|Reported Event|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
368134|NCT00406107|B3|Baseline|Total|Total of all reporting groups
368135|NCT00406107|B2|Baseline|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0 mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
368136|NCT00406107|B1|Baseline|Pegaptanib Sodium 0.3mg (Macugen)|Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
368137|NCT00406107|P2|Participant Flow|Pegaptanib Sodium 1 mg (Macugen)|
368139|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
368140|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
368141|NCT00406107|O2|Outcome|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
368142|NCT00406107|O1|Outcome|Pegaptanib Sodium 0.3mg (Macugen)|Patients experiencing an ocular adverse event, in this case a retinal detachment
368143|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
368144|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
368145|NCT00406107|E2|Reported Event|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
368146|NCT00406107|E1|Reported Event|Pegaptanib Sodium 0.3mg (Macugen)|Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
368147|NCT00406133|B5|Baseline|Total|Total of all reporting groups
368148|NCT00406133|B4|Baseline|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
368149|NCT00406133|B3|Baseline|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
368150|NCT00406133|B2|Baseline|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
368151|NCT00406133|B1|Baseline|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
368152|NCT00406133|P4|Participant Flow|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
368153|NCT00406133|P3|Participant Flow|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
368154|NCT00406133|P2|Participant Flow|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
368155|NCT00406133|P1|Participant Flow|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
368156|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
368157|NCT00406133|O1|Outcome|CGM Group|Participants who were randomized to CGM use
368158|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
368159|NCT00406133|O1|Outcome|CGM Group|Participants who were randomized to CGM use
368160|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
368161|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
368162|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
368163|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
368164|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
368165|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
368166|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368167|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368168|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368169|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368170|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HBA1c >=7.0% who were randomized to standard care
368171|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368172|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368173|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368174|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
368175|NCT00406133|O1|Outcome|CGM Group|Participants randomized to CGM Use
368176|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
368177|NCT00406133|O1|Outcome|CGM Group|Participants who were randomized to CGM use
368178|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
368179|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
368180|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
368181|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
368182|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
368183|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
368184|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368185|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368186|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368187|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368188|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
368189|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
368190|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
368191|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
368192|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
368193|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
368194|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368195|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368196|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368197|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368198|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
368199|NCT00406133|O1|Outcome|Primary Cohort RT-CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
368200|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368201|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368202|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368203|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368204|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368205|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368206|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368207|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368208|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
368209|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
368210|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
368211|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
368212|NCT00406133|E4|Reported Event|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
368213|NCT00406133|E3|Reported Event|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
368214|NCT00406133|E2|Reported Event|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
368215|NCT00406133|E1|Reported Event|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
368355|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368216|NCT00406276|B1|Baseline|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
368217|NCT00406276|P1|Participant Flow|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
368218|NCT00406276|O1|Outcome|Docetaxel/RAD001|
368219|NCT00406276|O1|Outcome|Docetaxel/RAD001|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
368220|NCT00406276|E1|Reported Event|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
368221|NCT00406315|B1|Baseline|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368222|NCT00406315|P1|Participant Flow|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368223|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368224|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368225|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368247|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368867|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368226|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368227|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368228|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368229|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368230|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368231|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368232|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368233|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
371208|NCT00410813|O1|Outcome|NTx at Baseline|
368234|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368235|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368236|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368237|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368238|NCT00406315|E1|Reported Event|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
368239|NCT00406354|B4|Baseline|Total|Total of all reporting groups
368240|NCT00406354|B3|Baseline|Placebo|matching placebo daily dose taken orally
368241|NCT00406354|B2|Baseline|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368242|NCT00406354|B1|Baseline|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368243|NCT00406354|P3|Participant Flow|Placebo|matching placebo daily dose taken orally
368244|NCT00406354|P2|Participant Flow|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368245|NCT00406354|P1|Participant Flow|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368246|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
371989|NCT00413400|B3|Baseline|Total|Total of all reporting groups
368248|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368249|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368250|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368251|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368252|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368253|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368254|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368255|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368256|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368257|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368258|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368259|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368260|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368261|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368262|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368263|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368264|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368265|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368266|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368267|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368268|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368269|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368270|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368271|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368272|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368273|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368274|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368275|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368276|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368277|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368278|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368279|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368280|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368281|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368282|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368283|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368284|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368285|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368286|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368287|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368288|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368289|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368290|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368291|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368868|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368292|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368293|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368294|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368295|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368296|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368297|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368298|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368299|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368300|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368301|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368302|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368303|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368304|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368305|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368306|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368307|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368308|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368309|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
368310|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
368311|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368312|NCT00406354|E3|Reported Event|Placebo|matching placebo daily dose taken orally
368313|NCT00406354|E2|Reported Event|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
371282|NCT00404924|B3|Baseline|Total|Total of all reporting groups
368314|NCT00406354|E1|Reported Event|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
368315|NCT00406367|B3|Baseline|Total|Total of all reporting groups
368316|NCT00406367|B2|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
368317|NCT00406367|B1|Baseline|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
368318|NCT00406367|P2|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
368319|NCT00406367|P1|Participant Flow|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
368320|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
368321|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
368322|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
368323|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
368324|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
368325|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
368326|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
368327|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
368328|NCT00406367|E2|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
372611|NCT00414206|O2|Outcome|0.3% Mecamylamine|
368329|NCT00406367|E1|Reported Event|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
368330|NCT00406393|B3|Baseline|Total|Total of all reporting groups
368331|NCT00406393|B2|Baseline|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368332|NCT00406393|B1|Baseline|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368333|NCT00406393|P2|Participant Flow|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368334|NCT00406393|P1|Participant Flow|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368335|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368336|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368337|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368338|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368339|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368340|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368341|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368342|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368343|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368344|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368345|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368346|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368347|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368348|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368349|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368350|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368351|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368352|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368353|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368354|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
371283|NCT00404924|B2|Baseline|Placebo|Placebo plus best supportive care
368356|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368357|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368358|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368359|NCT00406393|E2|Reported Event|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
368360|NCT00406393|E1|Reported Event|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
368361|NCT00406640|B3|Baseline|Total|Total of all reporting groups
368362|NCT00406640|B2|Baseline|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
368363|NCT00406640|B1|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
368364|NCT00406640|P2|Participant Flow|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
372612|NCT00414206|O1|Outcome|1% Mecamylamine|
368365|NCT00406640|P1|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
368366|NCT00406640|O2|Outcome|Escitalopram (ESC)|Taper Phase Day 239 or at discontinuation: If patients taking escitalopram 20 mg/day, then decrease to 10 mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10 mg/day decreased to matching escitalopram placebo/day for 7 days.
368367|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
368368|NCT00406640|O2|Outcome|ESC Non-Responders / DVS SR OL|Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
368369|NCT00406640|O1|Outcome|DVS SR Non-Responders / DVS SR OL|Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
368370|NCT00406640|O2|Outcome|ESC Non-Responders / DVS SR OL|Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
368371|NCT00406640|O1|Outcome|DVS SR Non-Responders / DVS SR OL|Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
368372|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
368373|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
368431|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368374|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
368375|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
368376|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
368377|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
368378|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
368379|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
368405|NCT00406653|P1|Participant Flow|Abatacept (ABA) 30/~10 mg/kg, Induction Period (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368406|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
368407|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
368380|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
368381|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
368382|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
368383|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
368384|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
368385|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
368386|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
368387|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
368408|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
368388|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
368389|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
368390|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
368391|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
368392|NCT00406640|E2|Reported Event|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
368393|NCT00406640|E1|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
368394|NCT00406653|B5|Baseline|Total|Total of all reporting groups
368395|NCT00406653|B4|Baseline|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368396|NCT00406653|B3|Baseline|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
368397|NCT00406653|B2|Baseline|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
368398|NCT00406653|B1|Baseline|ABA 30/~10 mg/kg, Induction Period (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368399|NCT00406653|P7|Participant Flow|ABA ~10 mg/kg, Open-Label Period (OL)|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
368400|NCT00406653|P6|Participant Flow|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368401|NCT00406653|P5|Participant Flow|ABA ~10 mg/kg, Maintenance Period (MP)|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368402|NCT00406653|P4|Participant Flow|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368403|NCT00406653|P3|Participant Flow|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
368404|NCT00406653|P2|Participant Flow|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
372613|NCT00414206|E3|Reported Event|Placebo|
368409|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
368410|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
368411|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368412|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368413|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368414|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368415|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368416|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368417|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368418|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368419|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368420|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368421|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368422|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368423|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368424|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368425|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
368426|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368427|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368428|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368429|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368430|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
369756|NCT00401752|E1|Reported Event|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
368432|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368433|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368434|NCT00406653|O4|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368435|NCT00406653|O3|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
368436|NCT00406653|O2|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
368437|NCT00406653|O1|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368438|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368439|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
368440|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
368441|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368442|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368443|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
368444|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
368445|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368446|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
368447|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
368869|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368448|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368449|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368450|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
368451|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
368452|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368453|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368454|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
368455|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
368456|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368457|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368458|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
368459|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
368460|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368461|NCT00406653|O4|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368462|NCT00406653|O3|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
368820|NCT00394589|B1|Baseline|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
368463|NCT00406653|O2|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
368464|NCT00406653|O1|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368465|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368466|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
368467|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
368468|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368469|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
368470|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368471|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368472|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368473|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
368474|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
368475|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368476|NCT00406653|E7|Reported Event|Placebo (MP)|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
368477|NCT00406653|E6|Reported Event|Placebo (IP)|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
368478|NCT00406653|E5|Reported Event|ABA ~10mg/kg (OL)|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
368479|NCT00406653|E4|Reported Event|ABA ~10mg/kg (MP)|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
368480|NCT00406653|E3|Reported Event|ABA ~10mg/kg (IP)|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
368481|NCT00406653|E2|Reported Event|ABA 3mg/kg (IP)|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
368870|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368482|NCT00406653|E1|Reported Event|ABA 30/~10mg/kg (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
368483|NCT00406692|B1|Baseline|Zonisamide|400 mg daily
368484|NCT00406692|P1|Participant Flow|Zonisamide|400 mg daily
368485|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
368486|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
368487|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
368488|NCT00406692|E1|Reported Event|Zonisamide|400 mg daily
368489|NCT00406718|B4|Baseline|Total|Total of all reporting groups
368490|NCT00406718|B3|Baseline|Standard Treatment|"Participants will receive standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
368491|NCT00406718|B2|Baseline|Med-eMonitor|"Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
368492|NCT00406718|B1|Baseline|PharmCAT|"Participants will receive PharmCAT
PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
368493|NCT00406718|P3|Participant Flow|Treatment as Usual|"standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
368494|NCT00406718|P2|Participant Flow|Med-eMonitor|"Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
368495|NCT00406718|P1|Participant Flow|Pharm CAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
368670|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368496|NCT00406718|O3|Outcome|Treatment as Usual|"standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
368497|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
368498|NCT00406718|O1|Outcome|Pharm CAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
368499|NCT00406718|O3|Outcome|Standard|"Participants will receive standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
368500|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
368501|NCT00406718|O1|Outcome|PharmCAT|"Participants will receive PharmCAT
PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
368502|NCT00406718|O3|Outcome|Standard|"Participants will receive standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
368503|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
368504|NCT00406718|O1|Outcome|PharmCAT|"Participants will receive PharmCAT
PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
368505|NCT00406718|E3|Reported Event|Standard Treatment|"Participants will receive standard treatment
Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
368506|NCT00406718|E2|Reported Event|Med-eMonitor|"Participants will receive the Med-eMonitor™
Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
368507|NCT00406718|E1|Reported Event|PharmCAT|"Participants will receive PharmCAT
PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
368508|NCT00406783|B3|Baseline|Total|Total of all reporting groups
368509|NCT00406783|B2|Baseline|Placebo Tablet|placebo tablet, once daily for 15 days
368510|NCT00406783|B1|Baseline|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
368511|NCT00406783|P2|Participant Flow|Placebo Tablet|placebo tablet, once daily for 15 days
368512|NCT00406783|P1|Participant Flow|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
368513|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
368514|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
368515|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
368516|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
368517|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
368518|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
368519|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
368520|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
368521|NCT00406783|E2|Reported Event|Placebo Tablet|placebo tablet, once daily for 15 days
368522|NCT00406783|E1|Reported Event|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
368523|NCT00406848|B3|Baseline|Total|Total of all reporting groups
368524|NCT00406848|B2|Baseline|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
369757|NCT00401778|B4|Baseline|Total|Total of all reporting groups
368525|NCT00406848|B1|Baseline|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368526|NCT00406848|P2|Participant Flow|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368527|NCT00406848|P1|Participant Flow|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368528|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368529|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368530|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368531|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368532|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368871|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368872|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368533|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368534|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368535|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368536|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368537|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368538|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368626|NCT00407355|O2|Outcome|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
375510|NCT00425100|O1|Outcome|Open Label Baseline|
368539|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368540|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368541|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368542|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368543|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368544|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368545|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368546|NCT00406848|O3|Outcome|Placebo Rescue|Participants who were randomized to placebo at baseline and for whom rescue treatment was required during the continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they were rescued to duloxetine 60 milligrams (mg) orally once daily (QD) beginning with duloxetine 30 mg QD orally for one week followed by duloxetine 60 mg QD orally until completing or discontinuing from the study.
368547|NCT00406848|O2|Outcome|Placebo Non-rescue|Participants who were randomized to placebo at baseline and for whom treatment rescue was not required during continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they continued to receive placebo until completing or discontinuing from the study.
372614|NCT00414206|E2|Reported Event|0.3% Mecamylamine|
368548|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368549|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368550|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368551|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368552|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368553|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368554|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368555|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368556|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368557|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368558|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368559|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368560|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368561|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368562|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
369800|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
368563|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368564|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368565|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368566|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368567|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368568|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368569|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368570|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368571|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368572|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368573|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368574|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368575|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368576|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368577|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
372615|NCT00414206|E1|Reported Event|1% Mecamylamine|
368578|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368579|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368580|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368581|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368582|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368583|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
368584|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368585|NCT00406848|E3|Reported Event|Rescued Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants were rescued to duloxetine 60 milligrams (mg) orally once daily (QD) beginning with duloxetine 30 mg QD orally for one week followed by duloxetine 60 mg QD orally for the remainder of the study. Results are for the randomized placebo patients who were rescued to duloxetine and reported events while they were on duloxetine.
368586|NCT00406848|E2|Reported Event|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity. Results are for the randomized placebo patients who reported events while they were on placebo.
368587|NCT00406848|E1|Reported Event|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
368588|NCT00407030|B4|Baseline|Total|Total of all reporting groups
368589|NCT00407030|B3|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
368590|NCT00407030|B2|Baseline|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
368591|NCT00407030|B1|Baseline|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
368592|NCT00407030|P3|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
368593|NCT00407030|P2|Participant Flow|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
368594|NCT00407030|P1|Participant Flow|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
368873|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
372616|NCT00414310|B3|Baseline|Total|Total of all reporting groups
368595|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
368596|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
368597|NCT00407030|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
368598|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
368599|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
368600|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
368601|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
368602|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
368668|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368603|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
368604|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
368605|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
368606|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
368607|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
368608|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
368609|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
368610|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
368611|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
368612|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
368613|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
368614|NCT00407030|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
368615|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
368689|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368616|NCT00407030|E3|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
368617|NCT00407030|E2|Reported Event|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
368618|NCT00407030|E1|Reported Event|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
368619|NCT00407355|B3|Baseline|Total|Total of all reporting groups
368620|NCT00407355|B2|Baseline|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
368621|NCT00407355|B1|Baseline|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
368622|NCT00407355|P2|Participant Flow|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
368623|NCT00407355|P1|Participant Flow|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
368624|NCT00407355|O2|Outcome|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
368625|NCT00407355|O1|Outcome|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
368627|NCT00407355|O1|Outcome|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
368628|NCT00407355|E2|Reported Event|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
368629|NCT00407355|E1|Reported Event|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
368630|NCT00407381|B4|Baseline|Total|Total of all reporting groups
368631|NCT00407381|B3|Baseline|Laser With RBZ|"Laser following intravitreal injection of RBZ
Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.
Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
368632|NCT00407381|B2|Baseline|Laser Only|"Laser photocoagulation
Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
368633|NCT00407381|B1|Baseline|Ranibizumab Only|"RBZ intravitreal injection alone
Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
368634|NCT00407381|P3|Participant Flow|Laser With Ranibizumab (RBZ)|"Laser following intravitreal injection of RBZ
Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.
Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
368635|NCT00407381|P2|Participant Flow|Laser Only|"Laser photocoagulation
Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
368636|NCT00407381|P1|Participant Flow|Ranibizumab Only|"Ranibizumab (RBZ) intravitreal injection alone
Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria."
368637|NCT00407381|O3|Outcome|Laser With RBZ|"Laser following intravitreal injection of RBZ
Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.
Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
368638|NCT00407381|O2|Outcome|Laser Alone|"Laser photocoagulation
Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
368639|NCT00407381|O1|Outcome|RBZ Alone|"RBZ intravitreal injection alone
Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
368640|NCT00407381|E3|Reported Event|Laser With Ranibizumab|"Laser following intravitreal injection of RBZ
Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.
Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
368641|NCT00407381|E2|Reported Event|Laser Only|"Laser photocoagulation
Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
368642|NCT00407381|E1|Reported Event|Ranibizumab Only|"RBZ intravitreal injection alone
Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
368643|NCT00407485|B1|Baseline|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
pharmacological study: Correlative studies"
368644|NCT00407485|P1|Participant Flow|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
pharmacological study: Correlative studies"
368874|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
373556|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
368645|NCT00407485|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
pharmacological study: Correlative studies"
368646|NCT00407485|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
pharmacological study: Correlative studies"
368647|NCT00407485|E1|Reported Event|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
pharmacological study: Correlative studies"
368648|NCT00407511|B1|Baseline|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368649|NCT00407511|P1|Participant Flow|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368650|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368669|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368818|NCT00394589|B3|Baseline|Control|Continuation of infliximab 3 mg/kg every 8 weeks
375511|NCT00425100|O1|Outcome|Open Label Week 12|
368651|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368652|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368653|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368654|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368655|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368656|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368657|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368658|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368659|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368690|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
373557|NCT00420017|O2|Outcome|Control|Control usual care
368660|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368661|NCT00407511|E1|Reported Event|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
368662|NCT00407537|B3|Baseline|Total|Total of all reporting groups
368663|NCT00407537|B2|Baseline|Usual Care as Assigned|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368664|NCT00407537|B1|Baseline|Caduet as Assigned|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368665|NCT00407537|P2|Participant Flow|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368666|NCT00407537|P1|Participant Flow|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368667|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368671|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368672|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368673|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368674|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368675|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368676|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368677|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368678|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368679|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368680|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368681|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368682|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368683|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368684|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368685|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368686|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368687|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368688|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368691|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368692|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368693|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368694|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368695|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368696|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368697|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368698|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368699|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368700|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368701|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368702|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368819|NCT00394589|B2|Baseline|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
375512|NCT00425100|O2|Outcome|Open Label Week 12|
368703|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368704|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368705|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368706|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368707|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368708|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368709|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368710|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368711|NCT00407537|E2|Reported Event|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
368712|NCT00407537|E1|Reported Event|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
368713|NCT00407550|B3|Baseline|Total|Total of all reporting groups
368714|NCT00407550|B2|Baseline|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
368715|NCT00407550|B1|Baseline|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
368716|NCT00407550|P2|Participant Flow|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
368717|NCT00407550|P1|Participant Flow|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
368718|NCT00407550|O2|Outcome|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
368719|NCT00407550|O1|Outcome|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
368720|NCT00407550|E2|Reported Event|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
368721|NCT00407550|E1|Reported Event|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
368722|NCT00407563|B1|Baseline|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
368723|NCT00407563|P1|Participant Flow|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
368724|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
369801|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
368725|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
368726|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
368727|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
368728|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
368729|NCT00407563|E1|Reported Event|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
368730|NCT00407654|B1|Baseline|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
368731|NCT00407654|P1|Participant Flow|VEGF Trap IV Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given intravenously
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
368732|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
aflibercept: Given intravenously"
368733|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
aflibercept: Given intravenously"
368821|NCT00394589|P3|Participant Flow|Control|Continuation of infliximab 3 mg/kg every 8 weeks
368734|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
aflibercept: Given intravenously"
368735|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
aflibercept: Given intravenously"
368736|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
aflibercept: Given intravenously"
368737|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
aflibercept: Given intravenously"
368738|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given intravenously
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
368739|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
aflibercept: Given intravenously"
368740|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given intravenously
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
368741|NCT00407654|E1|Reported Event|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
368742|NCT00407745|B3|Baseline|Total|Total of all reporting groups
368743|NCT00407745|B2|Baseline|Placebo|Placebo matching study treatment.
368744|NCT00407745|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368745|NCT00407745|P2|Participant Flow|Placebo|Placebo matching study treatment.
368746|NCT00407745|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368747|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368748|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368749|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368857|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368750|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368751|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368752|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368753|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368754|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368755|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368756|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368757|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368758|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368759|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368760|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368761|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368762|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368763|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368764|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368765|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368766|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368767|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368768|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368769|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368858|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368859|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368860|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368770|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368771|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368772|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368773|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368774|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368775|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368776|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368777|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368778|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368779|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368780|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368781|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368782|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368783|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368784|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368785|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368786|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368787|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368788|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368789|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368861|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368862|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368863|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368790|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368791|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368792|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368793|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368794|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368795|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368796|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368797|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368798|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368799|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368800|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368801|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368802|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368803|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368804|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368805|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368806|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368807|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368808|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368809|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368864|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368865|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368866|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368810|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368811|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368812|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368813|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
368814|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368815|NCT00407745|E2|Reported Event|Placebo|Placebo matching study treatment.
368816|NCT00407745|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
368817|NCT00394589|B4|Baseline|Total|Total of all reporting groups
368822|NCT00394589|P2|Participant Flow|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
368823|NCT00394589|P1|Participant Flow|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
368824|NCT00394589|O3|Outcome|Control|Continuation of infliximab 3 mg/kg every 8 weeks
368825|NCT00394589|O2|Outcome|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
368826|NCT00394589|O1|Outcome|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
368827|NCT00394589|E3|Reported Event|Control*Infliximab*3mg/kg Q8W|
368828|NCT00394589|E2|Reported Event|Infliximab*3mg/kg Q6W|
368829|NCT00394589|E1|Reported Event|Infliximab*3mg/kg+1*Vial Q8W|
368830|NCT00394654|B3|Baseline|Total|Total of all reporting groups
368831|NCT00394654|B2|Baseline|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368832|NCT00394654|B1|Baseline|PLACEBO|
368833|NCT00394654|P2|Participant Flow|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368834|NCT00394654|P1|Participant Flow|PLACEBO|
368835|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368836|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368837|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368838|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368839|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368840|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368841|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368842|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368843|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368844|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368845|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368846|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368847|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368848|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368849|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368850|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368851|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368852|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368853|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368854|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368855|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368856|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
373558|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
368875|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368876|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368877|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368878|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368879|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368880|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368881|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368882|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368883|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368884|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368885|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368886|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368887|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368888|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368889|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368890|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368891|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368892|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
368893|NCT00394654|E2|Reported Event|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
368894|NCT00394654|E1|Reported Event|PLACEBO|
368895|NCT00394706|B9|Baseline|Total|Total of all reporting groups
368896|NCT00394706|B8|Baseline|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
368897|NCT00394706|B7|Baseline|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
368945|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368898|NCT00394706|B6|Baseline|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
368899|NCT00394706|B5|Baseline|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
368900|NCT00394706|B4|Baseline|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
368901|NCT00394706|B3|Baseline|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
368902|NCT00394706|B2|Baseline|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
368903|NCT00394706|B1|Baseline|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
368904|NCT00394706|P8|Participant Flow|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
368905|NCT00394706|P7|Participant Flow|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
368906|NCT00394706|P6|Participant Flow|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
368907|NCT00394706|P5|Participant Flow|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
368908|NCT00394706|P4|Participant Flow|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
368961|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
369066|NCT00394901|P1|Participant Flow|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
368909|NCT00394706|P3|Participant Flow|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
368910|NCT00394706|P2|Participant Flow|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
368911|NCT00394706|P1|Participant Flow|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
368912|NCT00394706|O4|Outcome|Sham ITD|Sham ITD used by EMS providers in the pre-hospital setting.
368913|NCT00394706|O3|Outcome|Active ITD|Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
368914|NCT00394706|O2|Outcome|Analyze Later|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
368915|NCT00394706|O1|Outcome|Analyze Early|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
368916|NCT00394706|O4|Outcome|Sham ITD|Sham ITD used by EMS providers in the pre-hospital setting.
368917|NCT00394706|O3|Outcome|Active ITD|Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
368918|NCT00394706|O2|Outcome|Analyze Later|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
368919|NCT00394706|O1|Outcome|Analyze Early|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
375513|NCT00425100|O1|Outcome|Open Label Baseline|
368920|NCT00394706|E8|Reported Event|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
368921|NCT00394706|E7|Reported Event|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
368922|NCT00394706|E6|Reported Event|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
368923|NCT00394706|E5|Reported Event|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
368924|NCT00394706|E4|Reported Event|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
368925|NCT00394706|E3|Reported Event|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
368926|NCT00394706|E2|Reported Event|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
368927|NCT00394706|E1|Reported Event|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
368928|NCT00394771|B5|Baseline|Total|Total of all reporting groups
368929|NCT00394771|B4|Baseline|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368930|NCT00394771|B3|Baseline|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368931|NCT00394771|B2|Baseline|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368932|NCT00394771|B1|Baseline|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368933|NCT00394771|P4|Participant Flow|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368934|NCT00394771|P3|Participant Flow|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368935|NCT00394771|P2|Participant Flow|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368936|NCT00394771|P1|Participant Flow|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368937|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368938|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368939|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368940|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368941|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368942|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368943|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368944|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368946|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368947|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368948|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368949|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368950|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368951|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368952|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368953|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368954|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368955|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368956|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368957|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368958|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368959|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368960|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
369802|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
368962|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368963|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368964|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368965|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368966|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368967|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368968|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368969|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368970|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368971|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368972|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368973|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368974|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368975|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368976|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368977|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368978|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368979|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368980|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368981|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368982|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368983|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368984|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368985|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368986|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368987|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368988|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
369065|NCT00394901|P2|Participant Flow|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
368989|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368990|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368991|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368992|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368993|NCT00394771|E4|Reported Event|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
368994|NCT00394771|E3|Reported Event|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368995|NCT00394771|E2|Reported Event|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368996|NCT00394771|E1|Reported Event|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
368997|NCT00394836|B3|Baseline|Total|Total of all reporting groups
368998|NCT00394836|B2|Baseline|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
368999|NCT00394836|B1|Baseline|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369000|NCT00394836|P2|Participant Flow|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new Follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
370167|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
369001|NCT00394836|P1|Participant Flow|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
369002|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369003|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369004|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369005|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369006|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369007|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369008|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369009|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369010|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369011|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369012|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369013|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369014|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369015|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369016|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369017|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369018|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369019|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369020|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369021|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369022|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369023|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369024|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369025|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369026|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369027|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369028|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369029|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369030|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369031|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369032|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369033|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369034|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369035|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369036|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369037|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369038|NCT00394836|E4|Reported Event|Ofatumumab 1000 mg: Extended Follow-up Phase|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new Follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
369039|NCT00394836|E3|Reported Event|Ofatumumab 500 mg: Extended Follow-up Phase|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
369040|NCT00394836|E2|Reported Event|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
369041|NCT00394836|E1|Reported Event|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
369042|NCT00394888|B4|Baseline|Total|Total of all reporting groups
369043|NCT00394888|B3|Baseline|Multiple Hemangiomas|Patients with multiple hemangiomas
369044|NCT00394888|B2|Baseline|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
369045|NCT00394888|B1|Baseline|Facial Hemangioma|Patients with large facial hemangioma.
369046|NCT00394888|P3|Participant Flow|Multiple Hemangiomas|Patients with multiple hemangiomas
369047|NCT00394888|P2|Participant Flow|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
369048|NCT00394888|P1|Participant Flow|Facial Hemangioma|Patients with large facial hemangioma.
369049|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
369050|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
369051|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
369052|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
369053|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
369054|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
369055|NCT00394888|E3|Reported Event|Multiple Hemangiomas|Patients with multiple hemangiomas
369056|NCT00394888|E2|Reported Event|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
369057|NCT00394888|E1|Reported Event|Facial Hemangioma|Patients with large facial hemangioma.
369058|NCT00394901|B5|Baseline|Total|Total of all reporting groups
369059|NCT00394901|B4|Baseline|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369060|NCT00394901|B3|Baseline|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369061|NCT00394901|B2|Baseline|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369062|NCT00394901|B1|Baseline|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369063|NCT00394901|P4|Participant Flow|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369064|NCT00394901|P3|Participant Flow|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369067|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369068|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369069|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369070|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369071|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369072|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369073|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369074|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369075|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369076|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369077|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369078|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369079|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369080|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369081|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369082|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369083|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369084|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369085|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369086|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369087|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369088|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369089|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369090|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369091|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369092|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369093|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369094|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369095|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369096|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369097|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369098|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369099|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369100|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369101|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369102|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369103|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369104|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369105|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369106|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369107|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369108|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369109|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369110|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369111|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369112|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369113|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369114|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369115|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369116|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369117|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369118|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369119|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369120|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369121|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369122|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369123|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369124|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
375514|NCT00425100|O2|Outcome|Open Label Week 12|
369125|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369126|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369127|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369128|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369129|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369130|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369131|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369132|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369133|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369134|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369135|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369136|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369137|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369138|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369139|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369140|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369141|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369142|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369143|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369144|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369145|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369146|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369147|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369148|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
373559|NCT00420017|E2|Reported Event|Control|Control usual care
369149|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369150|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369151|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369152|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369153|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369154|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369155|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369156|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369157|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369158|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369159|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369160|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369161|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369162|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369163|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369164|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369165|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369166|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369167|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369168|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369169|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369170|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369171|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369172|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369173|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369174|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369175|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369176|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369177|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369178|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369179|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369180|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369181|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369182|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369183|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369184|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369185|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369186|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369187|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369188|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369189|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369190|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369191|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369192|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369193|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369194|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369195|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369196|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369197|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369198|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369199|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369200|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369201|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369202|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369203|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369204|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369205|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369206|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369288|NCT00394901|E2|Reported Event|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369207|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369208|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369209|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369210|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369211|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369212|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369213|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369214|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369215|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369216|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369217|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369218|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369219|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369220|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369221|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369222|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369223|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369224|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369225|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369226|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369227|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369228|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369229|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369230|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369231|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369232|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369233|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369234|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369235|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369236|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369237|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369238|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369239|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369240|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369241|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369242|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369243|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369244|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369245|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369246|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369247|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369248|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369249|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369250|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369251|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369252|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369253|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369254|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369255|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369256|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369257|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369258|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369259|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369260|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369261|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369262|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369263|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369264|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369265|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369266|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369267|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369268|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369269|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369270|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369271|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369272|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
373560|NCT00420017|E1|Reported Event|Amiodarone|Intravenous amiodarone
369273|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369274|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369275|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369276|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369277|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369278|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369279|NCT00394901|O3|Outcome|Expected Pregabalin Exposure of 600 mg/Day|Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 300 mg/day and subjects who received pregabalin 600 mg/day.
369280|NCT00394901|O2|Outcome|Expected Pregabalin Exposure of 300 mg/Day|Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 150 mg/day and subjects with normal CLcr (> 60 mL/min) who received pregabalin 300 mg/day.
369281|NCT00394901|O1|Outcome|Placebo|Subjects who received matching placebo during a 13-week double-blind treatment phase.
369282|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369283|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
369284|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
369285|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369286|NCT00394901|E4|Reported Event|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
369287|NCT00394901|E3|Reported Event|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
370470|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
369289|NCT00394901|E1|Reported Event|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
369290|NCT00400400|B3|Baseline|Total|Total of all reporting groups
369291|NCT00400400|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369292|NCT00400400|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369293|NCT00400400|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369294|NCT00400400|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369295|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369296|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369297|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369298|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369321|NCT00400569|E1|Reported Event|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
369322|NCT00400634|B3|Baseline|Total|Total of all reporting groups
369299|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369300|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369301|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369302|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369303|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369335|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
370473|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
369304|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369305|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369306|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369307|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369308|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369309|NCT00400400|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369310|NCT00400400|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
369311|NCT00400569|B1|Baseline|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
369312|NCT00400569|P1|Participant Flow|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
369313|NCT00400569|O1|Outcome|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
369314|NCT00400569|O3|Outcome|Malignant Fibrous Histiocytoma (MFH) Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
369315|NCT00400569|O2|Outcome|Leiomyosarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
369316|NCT00400569|O1|Outcome|Liposarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
369317|NCT00400569|O3|Outcome|Malignant Fibrous Histiocytoma (MFH) Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
369318|NCT00400569|O2|Outcome|Leiomyosarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
369319|NCT00400569|O1|Outcome|Liposarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
369320|NCT00400569|O1|Outcome|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
369323|NCT00400634|B2|Baseline|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
369324|NCT00400634|B1|Baseline|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
369325|NCT00400634|P2|Participant Flow|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
369326|NCT00400634|P1|Participant Flow|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
369327|NCT00400634|O2|Outcome|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
369328|NCT00400634|O1|Outcome|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
369329|NCT00400634|O2|Outcome|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
369330|NCT00400634|O1|Outcome|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
369331|NCT00400634|E2|Reported Event|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
369332|NCT00400634|E1|Reported Event|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
369333|NCT00400686|B1|Baseline|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
369334|NCT00400686|P1|Participant Flow|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
369446|NCT00400881|E2|Reported Event|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
369336|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
369337|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
369338|NCT00400686|E1|Reported Event|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
369339|NCT00400712|B3|Baseline|Total|Total of all reporting groups
369340|NCT00400712|B2|Baseline|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation"
369341|NCT00400712|B1|Baseline|Control|natural progression post-stroke
369342|NCT00400712|P2|Participant Flow|Intervention|two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months (and one year)
369343|NCT00400712|P1|Participant Flow|Control|no intervention, natural history following stroke
369344|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation"
369345|NCT00400712|O1|Outcome|Control|natural progression post-stroke
369346|NCT00400712|O2|Outcome|Intervention|two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months .
369347|NCT00400712|O1|Outcome|Control|no intervention, natural progression post-stroke
369348|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation"
369349|NCT00400712|O1|Outcome|Control|natural progression post-stroke
369350|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation"
369351|NCT00400712|O1|Outcome|Control|natural progression post-stroke
369352|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation"
369353|NCT00400712|O1|Outcome|Control|natural progression post-stroke
369354|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation"
369355|NCT00400712|O1|Outcome|Control|natural progression post-stroke
369356|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation"
369357|NCT00400712|O1|Outcome|Control|natural progression post-stroke
369358|NCT00400712|E2|Reported Event|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation"
369359|NCT00400712|E1|Reported Event|Control|natural progression post-stroke
369360|NCT00400764|B6|Baseline|Total|Total of all reporting groups
369361|NCT00400764|B5|Baseline|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369362|NCT00400764|B4|Baseline|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369363|NCT00400764|B3|Baseline|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369364|NCT00400764|B2|Baseline|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369365|NCT00400764|B1|Baseline|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369366|NCT00400764|P5|Participant Flow|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369367|NCT00400764|P4|Participant Flow|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369368|NCT00400764|P3|Participant Flow|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369369|NCT00400764|P2|Participant Flow|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369370|NCT00400764|P1|Participant Flow|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369447|NCT00400881|E1|Reported Event|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
369371|NCT00400764|O2|Outcome|Phase II Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants may also have received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369372|NCT00400764|O1|Outcome|Phase Ib Dulanermin|Participants received 4.0 mg/kg/day or 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369373|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369374|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369375|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369376|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369377|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369378|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369379|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369380|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369381|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369382|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369383|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369384|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369385|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369386|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369432|NCT00400829|P1|Participant Flow|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV"
369387|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369388|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369389|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369390|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369391|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369392|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369393|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369394|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369395|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369448|NCT00400946|B6|Baseline|Total|Total of all reporting groups
370661|NCT00410072|E1|Reported Event|ETV 0.5 mg|ETV 0.5 mg monotherapy given QD for 100 weeks
369396|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369397|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369398|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369399|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369400|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369401|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369402|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369403|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369404|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369405|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369406|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369407|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369408|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369409|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369410|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369411|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369412|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369459|NCT00400946|O5|Outcome|Traumatic Tap Without Blasts|Traumatic Tap without Blasts: without blast cells and >100 RBCs on a wet prep
369413|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369414|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369415|NCT00400764|E5|Reported Event|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
369416|NCT00400764|E4|Reported Event|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369417|NCT00400764|E3|Reported Event|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
369418|NCT00400764|E2|Reported Event|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
369419|NCT00400764|E1|Reported Event|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
370662|NCT00410124|B3|Baseline|Total|Total of all reporting groups
369420|NCT00400803|B1|Baseline|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
369421|NCT00400803|P1|Participant Flow|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
369422|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
369423|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
369424|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
369425|NCT00400803|O4|Outcome|Progressive Disease|At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
369426|NCT00400803|O3|Outcome|Stable Disease|Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval.
369427|NCT00400803|O2|Outcome|Partial Response|At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.
369428|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine, Carboplatin and Avastin IV every 14 days.
369429|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
369430|NCT00400803|E1|Reported Event|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
369431|NCT00400829|B1|Baseline|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV"
369460|NCT00400946|O4|Outcome|Traumatic Tap With Blasts|Traumatic Tap with Blasts: with blast cells and >100 RBCs on a wet prep
373863|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
369433|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV"
369434|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV"
369435|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV"
369436|NCT00400829|E1|Reported Event|Arm I|"Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV"
369437|NCT00400881|B3|Baseline|Total|Total of all reporting groups
369438|NCT00400881|B2|Baseline|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
369439|NCT00400881|B1|Baseline|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
369440|NCT00400881|P2|Participant Flow|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
369441|NCT00400881|P1|Participant Flow|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
369442|NCT00400881|O2|Outcome|ATC (AT Comp)|Automatic Tube Compensation
369443|NCT00400881|O1|Outcome|CPAP|Continuous Positive Airway Pressure
369444|NCT00400881|O2|Outcome|ATC (ATComp)|Automatic Tube Compensation
369445|NCT00400881|O1|Outcome|CPAP|Continuous Positive Airway Pressure
375515|NCT00425100|O1|Outcome|Open Label Baseline|
369449|NCT00400946|B5|Baseline|Expansion Cohort|Patients were enrolled in an expansion cohort to determine the prognostic significance of response to remission induction chemotherapy as measured by morphologic and minimal residual disease (MRD), and to further evaluate the efficacy of patients by final risk classification.
369450|NCT00400946|B4|Baseline|Ineligible for Randomization|All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who did not achieve complete remission and were not assigned a final risk group by the end of the induction phase of treatment were not eligible for randomization. Patients who developed severe pancreatitis (defined as symptoms persisting for >72 h) during induction were not eligible for randomization and received no further doses of asparaginase. Patients who had hypersensitivity to intravenous PEG-asparaginase during induction were also ineligible for randomization, but received twice-weekly IM-EC (25 000 IU/m2) during the post-induction treatment phases.
369451|NCT00400946|B3|Baseline|IM-EC [Directly Assigned]|Ph+ ALL patients did not participate in asparaginase randomization but were directly assigned to receive intramuscular E coli L-asparaginase during post-induction therapy. Patients who were eligible but declined randomization were also directly assigned to receive intramuscular E coli L-asparaginase.
369452|NCT00400946|B2|Baseline|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369453|NCT00400946|B1|Baseline|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369454|NCT00400946|P5|Participant Flow|Expansion Cohort|Patients were enrolled in an expansion cohort to determine the prognostic significance of response to remission induction chemotherapy as measured by morphologic and minimal residual disease (MRD), and to further evaluate the efficacy of patients by final risk classification.
369455|NCT00400946|P4|Participant Flow|Ineligible for Randomization|All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who did not achieve complete remission and were not assigned a final risk group by the end of the induction phase of treatment were not eligible for randomization. Patients who developed severe pancreatitis (defined as symptoms persisting for >72 h) during induction were not eligible for randomization and received no further doses of asparaginase. Patients who had hypersensitivity to intravenous PEG-asparaginase during induction were also ineligible for randomization, but received twice-weekly IM-EC (25 000 IU/m2) during the post-induction treatment phases.
369456|NCT00400946|P3|Participant Flow|IM-EC [Directly Assigned]|Ph+ ALL patients did not participate in asparaginase randomization but were directly assigned to receive intramuscular E coli L-asparaginase during post-induction therapy. Patients who were eligible but declined randomization were also directly assigned to receive intramuscular E coli L-asparaginase.
369457|NCT00400946|P2|Participant Flow|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369458|NCT00400946|P1|Participant Flow|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369463|NCT00400946|O1|Outcome|CNS-1|CNS-1: no blast cells in cytospin, regardless of cerebrospinal fluid (CSF) count
369464|NCT00400946|O3|Outcome|Hypocellular Day 18 Bone Marrow Status|Hypocellular marrow morphology at day 18 was defined as empty blasts.
369465|NCT00400946|O2|Outcome|M2/M3 Day 18 Bone Marrow Status|M2 marrow morphology at day 18 was defined as 5-24% blasts. M3 marrow morphology at day 18 was defined as >25% blasts.
369466|NCT00400946|O1|Outcome|M1 Day 18 Bone Marrow Status|M1 marrow morphology at day 18 was defined as <5% blasts.
369467|NCT00400946|O2|Outcome|High Day 32 MRD Level|High end-induction (day 32) minimal residual disease (MRD) evaluated was defined as >/=0.001. This MRD classification was one component of determining final risk classification. Peripheral blood samples were collected for evaluation of MRD using PCR methods
369468|NCT00400946|O1|Outcome|Low Day 32 MRD Level|Low end-induction (day 32) minimal residual disease (MRD) evaluated was defined as <0.001. This MRD classification was one component of determining final risk classification. Peripheral blood samples were collected for evaluation of MRD using PCR methods.
369469|NCT00400946|O1|Outcome|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
369518|NCT00401245|P1|Participant Flow|DVS 25 mg, Then 100 mg|Desvenlafaxine succinate (DVS) 25 milligram (mg) tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week open label (OL) phase.
375516|NCT00425100|O2|Outcome|Open Label Week 12|
369470|NCT00400946|O1|Outcome|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
369471|NCT00400946|O1|Outcome|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
369472|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369473|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369474|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369475|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369476|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369477|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369509|NCT00401245|B2|Baseline|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369478|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369479|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369480|NCT00400946|E3|Reported Event|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
369519|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
369481|NCT00400946|E2|Reported Event|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369482|NCT00400946|E1|Reported Event|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
369483|NCT00401102|B1|Baseline|Group 1|All participants recieved Interpersonal psychotherapy
369484|NCT00401102|P1|Participant Flow|Group 1|All participants recieved Interpersonal psychotherapy
369485|NCT00401102|O1|Outcome|Group 1|All participants recieved Interpersonal psychotherapy
369486|NCT00401102|E1|Reported Event|Group 1|All participants recieved Interpersonal psychotherapy
369487|NCT00401193|B4|Baseline|Total|Total of all reporting groups
369488|NCT00401193|B3|Baseline|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
369489|NCT00401193|B2|Baseline|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
369490|NCT00401193|B1|Baseline|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
369491|NCT00401193|P3|Participant Flow|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
369492|NCT00401193|P2|Participant Flow|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
369493|NCT00401193|P1|Participant Flow|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
369494|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
369495|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
369496|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
369497|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
369498|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
369499|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
369500|NCT00401193|O3|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
369501|NCT00401193|O2|Outcome|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
369502|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
369503|NCT00401193|E3|Reported Event|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
369504|NCT00401193|E2|Reported Event|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
369505|NCT00401193|E1|Reported Event|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
369506|NCT00401245|B5|Baseline|Total|Total of all reporting groups
369507|NCT00401245|B4|Baseline|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369508|NCT00401245|B3|Baseline|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369803|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369510|NCT00401245|B1|Baseline|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369511|NCT00401245|P8|Participant Flow|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
369512|NCT00401245|P7|Participant Flow|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
369513|NCT00401245|P6|Participant Flow|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
369514|NCT00401245|P5|Participant Flow|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally every other day (QOD) alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
369515|NCT00401245|P4|Participant Flow|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369516|NCT00401245|P3|Participant Flow|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369517|NCT00401245|P2|Participant Flow|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
375517|NCT00425100|O1|Outcome|Open Label Baseline|
369520|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
369521|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
369522|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
369523|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
369524|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
369525|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
369526|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
369527|NCT00401245|O1|Outcome|DVS 100 mg|DVS 100 mg tablet taken orally daily for 15 weeks (OL phase).
369528|NCT00401245|O1|Outcome|DVS 100 mg|DVS 100 mg tablet taken orally daily for 15 weeks (OL phase).
369529|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
369530|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
369531|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
369532|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
369533|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369534|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369535|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369536|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369537|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
369538|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
369539|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
369540|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
369541|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
373864|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
369542|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
369543|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
369544|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
369545|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
369546|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
369547|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
369548|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
369549|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369550|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369673|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369551|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369552|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369553|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369554|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369555|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369556|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369557|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
369558|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
369559|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
369560|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
369561|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
369562|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
369563|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
369564|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
369565|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
369566|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
369567|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
369568|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
369569|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369570|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369571|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
369572|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
373865|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
369573|NCT00401245|E9|Reported Event|Placebo (Tapering Phase)|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
369574|NCT00401245|E8|Reported Event|DVS 50 mg/Placebo (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
369575|NCT00401245|E7|Reported Event|DVS 50/25 mg (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
369576|NCT00401245|E6|Reported Event|DVS 50 mg QOD (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
369577|NCT00401245|E5|Reported Event|DVS 100 mg (OL Phase)|After 1 week of double blind titration phase, DVS 100 mg tablet taken orally daily for 15 weeks.
369578|NCT00401245|E4|Reported Event|DVS 100 mg (Titration Phase)|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase).
369579|NCT00401245|E3|Reported Event|DVS 50 mg (Titration Phase)|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase).
369580|NCT00401245|E2|Reported Event|DVS 25/50 mg (Titration Phase)|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase).
369581|NCT00401245|E1|Reported Event|DVS 25 mg (Titration Phase)|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase).
369709|NCT00401622|O2|Outcome|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
369582|NCT00401258|B1|Baseline|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
369583|NCT00401258|P1|Participant Flow|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
369584|NCT00401258|O1|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
369585|NCT00401258|E1|Reported Event|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
369586|NCT00401401|B5|Baseline|Total|Total of all reporting groups
369587|NCT00401401|B4|Baseline|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
369588|NCT00401401|B3|Baseline|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
369589|NCT00401401|B2|Baseline|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
369590|NCT00401401|B1|Baseline|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
369591|NCT00401401|P4|Participant Flow|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
369592|NCT00401401|P3|Participant Flow|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
369593|NCT00401401|P2|Participant Flow|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
369594|NCT00401401|P1|Participant Flow|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
369595|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
369596|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
369597|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
369598|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
369599|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
369600|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
369601|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
369602|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
369603|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
369604|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
369605|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
369606|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
369607|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|
369608|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|
369609|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|
369610|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|
369611|NCT00401401|E4|Reported Event|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
369612|NCT00401401|E3|Reported Event|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
369613|NCT00401401|E2|Reported Event|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
369614|NCT00401401|E1|Reported Event|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
369615|NCT00401414|B4|Baseline|Total|Total of all reporting groups
369616|NCT00401414|B3|Baseline|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
369658|NCT00401531|E1|Reported Event|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369659|NCT00401544|B5|Baseline|Total|Total of all reporting groups
373866|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
369617|NCT00401414|B2|Baseline|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
369618|NCT00401414|B1|Baseline|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.
Doses were subsequently adjusted based on serial INR measurements."
369671|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369710|NCT00401622|O1|Outcome|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
369619|NCT00401414|P3|Participant Flow|Dosing Algorithm C|Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin’s PD effect as evident in the acquired patient data. Simulations using Algorithm C were repeated using the clinical endpoints described above to derive the optimal starting warfarin doses and titration scheme that was tested prospectively in subsequent patients enrolled in the CROWN study.
369620|NCT00401414|P2|Participant Flow|Dosing Algorithm B|Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
369621|NCT00401414|P1|Participant Flow|Dosing Algorithm A|"Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.
Doses were subsequently adjusted based on serial INR measurements."
369622|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
369623|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
369624|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.
Doses were subsequently adjusted based on serial INR measurements."
369625|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
369660|NCT00401544|B4|Baseline|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369661|NCT00401544|B3|Baseline|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369662|NCT00401544|B2|Baseline|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369804|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369626|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
369627|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.
Doses were subsequently adjusted based on serial INR measurements."
369628|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
369629|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
369630|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.
Doses were subsequently adjusted based on serial INR measurements."
369631|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
369632|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
369633|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.
Doses were subsequently adjusted based on serial INR measurements."
369634|NCT00401414|O3|Outcome|Dosing Algorithm C|
369635|NCT00401414|O2|Outcome|Dosing Algorithm B|
369663|NCT00401544|B1|Baseline|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369664|NCT00401544|P4|Participant Flow|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369805|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369636|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.
Doses were subsequently adjusted based on serial INR measurements."
369637|NCT00401414|E3|Reported Event|Dosing Algorithm C|
369638|NCT00401414|E2|Reported Event|Dosing Algorithm B|
369639|NCT00401414|E1|Reported Event|Dosing Algorithm A|
369640|NCT00401531|B3|Baseline|Total|Total of all reporting groups
369641|NCT00401531|B2|Baseline|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369672|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369642|NCT00401531|B1|Baseline|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369643|NCT00401531|P2|Participant Flow|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369644|NCT00401531|P1|Participant Flow|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369645|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369646|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369647|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369648|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369649|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369650|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369651|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369652|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369653|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369654|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369655|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369656|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369657|NCT00401531|E2|Reported Event|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
369665|NCT00401544|P3|Participant Flow|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369666|NCT00401544|P2|Participant Flow|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369667|NCT00401544|P1|Participant Flow|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369668|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369669|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369670|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
375518|NCT00425100|O2|Outcome|Open Label Week 12|
369674|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369675|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369676|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369677|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369678|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369679|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369680|NCT00401544|O4|Outcome|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369681|NCT00401544|O3|Outcome|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369682|NCT00401544|O2|Outcome|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369683|NCT00401544|O1|Outcome|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369684|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369685|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369686|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369687|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369688|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369689|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369690|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369691|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369692|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369693|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369694|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369695|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369696|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369697|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369799|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369698|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369699|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369700|NCT00401544|E4|Reported Event|Darbepoetin Alfa 500 µg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369701|NCT00401544|E3|Reported Event|Darbepoetin Alfa 500 µg (Without Iron)|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369702|NCT00401544|E2|Reported Event|Darbepoetin Alfa 300 µg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369703|NCT00401544|E1|Reported Event|Darbepoetin Alfa 300 µg (Without IV Iron)|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
369704|NCT00401622|B3|Baseline|Total|Total of all reporting groups
369705|NCT00401622|B2|Baseline|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
369706|NCT00401622|B1|Baseline|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
369707|NCT00401622|P2|Participant Flow|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
369708|NCT00401622|P1|Participant Flow|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
369711|NCT00401622|O2|Outcome|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
369712|NCT00401622|O1|Outcome|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
369713|NCT00401622|E2|Reported Event|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
369714|NCT00401622|E1|Reported Event|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
369715|NCT00401726|B3|Baseline|Total|Total of all reporting groups
369716|NCT00401726|B2|Baseline|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
369717|NCT00401726|B1|Baseline|Venlafaxine Extended Release (ER)|75-225 mg per day
369718|NCT00401726|P2|Participant Flow|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
369719|NCT00401726|P1|Participant Flow|Venlafaxine Extended Release (ER)|75-225 mg per day
369720|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|"Venlafaxine ER 75-225 mg per day plus Dialogues Time to Talk program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication."
369721|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
369722|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
369723|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
369724|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
369725|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
369726|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
369727|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
369728|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
369729|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
369730|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
369731|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
369732|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
369733|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
369734|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
369735|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
369736|NCT00401726|E2|Reported Event|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
369737|NCT00401726|E1|Reported Event|Venlafaxine Extended Release (ER)|75-225 mg per day
369738|NCT00401752|B3|Baseline|Total|Total of all reporting groups
369739|NCT00401752|B2|Baseline|Ranitidine|ranitidine 150 mg capsule bid oral administration
369740|NCT00401752|B1|Baseline|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
369741|NCT00401752|P2|Participant Flow|Ranitidine|ranitidine 150 mg capsule bid oral administration
369742|NCT00401752|P1|Participant Flow|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
369743|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
369744|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
369745|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
369746|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
369747|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
369748|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
369749|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
369750|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
369751|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
369752|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
369753|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
369758|NCT00401778|B3|Baseline|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
369759|NCT00401778|B2|Baseline|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
369760|NCT00401778|B1|Baseline|Control|No everolimus taken.
369761|NCT00401778|P3|Participant Flow|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
369762|NCT00401778|P2|Participant Flow|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
369763|NCT00401778|P1|Participant Flow|Control|No everolimus taken.
369764|NCT00401778|O2|Outcome|Everolimus 5 or 10 mg|Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
369765|NCT00401778|O1|Outcome|Control|No everolimus taken.
369766|NCT00401778|O3|Outcome|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
369767|NCT00401778|O2|Outcome|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
369768|NCT00401778|O1|Outcome|Control|No everolimus taken.
369769|NCT00401778|O3|Outcome|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
369770|NCT00401778|O2|Outcome|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
369771|NCT00401778|O1|Outcome|Control|No everolimus taken.
369772|NCT00401778|E2|Reported Event|Everolimus 5 & 10 mg|Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
369773|NCT00401778|E1|Reported Event|Control|No everolimus taken.
369774|NCT00401830|B3|Baseline|Total|Total of all reporting groups
369775|NCT00401830|B2|Baseline|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369776|NCT00401830|B1|Baseline|Placebo|Matching placebo tablet (administered twice daily)
369777|NCT00401830|P2|Participant Flow|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369778|NCT00401830|P1|Participant Flow|Placebo|Matching placebo tablet (administered twice daily)
369779|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369780|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369781|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369782|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369783|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369784|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369785|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369786|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369787|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369788|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369789|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369790|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369791|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369792|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369793|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369794|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369795|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369796|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369797|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369798|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369806|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
369807|NCT00401830|E2|Reported Event|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
369808|NCT00401830|E1|Reported Event|Placebo|Matching placebo tablet (administered twice daily)
369809|NCT00401843|B4|Baseline|Total|Total of all reporting groups
369810|NCT00401843|B3|Baseline|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.
Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
369811|NCT00401843|B2|Baseline|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.
Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
369812|NCT00401843|B1|Baseline|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
369834|NCT00401882|P1|Participant Flow|Additional Doses of Epinephrine|Epinephrine: additional doses Epinephrine (1 mg) IV given as part of standard of care in cardiac arrest
370697|NCT00410150|P2|Participant Flow|Control Group|Subjects randomized to the control arm of the study
369813|NCT00401843|P3|Participant Flow|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.
Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
369814|NCT00401843|P2|Participant Flow|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.
Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
369815|NCT00401843|P1|Participant Flow|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
369816|NCT00401843|O3|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
369817|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
369818|NCT00401843|O1|Outcome|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
369819|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
370227|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
369820|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
369821|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
369835|NCT00401882|O2|Outcome|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
369836|NCT00401882|O1|Outcome|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
369837|NCT00401882|O2|Outcome|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
369838|NCT00401882|O1|Outcome|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
369822|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
369823|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
369824|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
369825|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
369826|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
369827|NCT00401843|E3|Reported Event|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.
Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
369867|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369868|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
370282|NCT00409344|O1|Outcome|Saline|This group will recive saline
369828|NCT00401843|E2|Reported Event|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.
Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
369829|NCT00401843|E1|Reported Event|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
369830|NCT00401882|B3|Baseline|Total|Total of all reporting groups
369831|NCT00401882|B2|Baseline|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
369832|NCT00401882|B1|Baseline|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
369833|NCT00401882|P2|Participant Flow|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol: Metoprolol 5 mg IV (up to two times) instead of additional doses of epinephrine
369839|NCT00401882|O2|Outcome|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
369840|NCT00401882|O1|Outcome|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
369841|NCT00401882|O2|Outcome|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol: Metoprolol 5mg IV (up to two times only) instead of additional epinephrine doses
369842|NCT00401882|O1|Outcome|Additional Doses of Epinephrine|Epinephrine: Additional doses of epinephrine IV (1 mg) given as part of standard of care in cardiac arrest
369843|NCT00401882|O2|Outcome|Metoprolol Instead of Additional Epinephrine Doses|"IV metoprolol 5 mg. (up to 2 times only) during cardiac arrest will be given instead of additional Epinephrine doses
Metoprolol: Metoprolol 5 mg IV (up to two times only) instead of epinephrine additional doses"
369844|NCT00401882|O1|Outcome|Additional Epinephrine Doses|"Additional doses of Epinephrine (1 mg) given as part of standard of care during cardiac arrest
Epinephrine: Epinephrine (1 mg) IV additional doses"
369845|NCT00401882|O2|Outcome|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol 5 mg IV (up to 2 times) instead of additional epinephrine doses
369846|NCT00401882|O1|Outcome|Additional Doses of Epinephrine|Epinephrine: Additional doses of epinephrine (1 mg IV) given as part of standard of care during cardiac arrest
369847|NCT00401882|E2|Reported Event|Metoprolol Instead of Additional Doses of Epinephrine|Metoprolol: Metoprolol 5 mg IV (up to two times) instead of additional epinephrine doses
369848|NCT00401882|E1|Reported Event|Additional Doses of Epinephrine|Epinephrine: Additional doses epinephrine (1 mg IV) as part of standard of care during cardiac arrest
369849|NCT00401960|B3|Baseline|Total|Total of all reporting groups
369850|NCT00401960|B2|Baseline|Standard of Care Group|as per study description
369851|NCT00401960|B1|Baseline|Adjunctive Daptomycin Group|please see study description for study enrollment
369852|NCT00401960|P2|Participant Flow|Standard of Care Group|as per study description
369853|NCT00401960|P1|Participant Flow|Adjunctive Daptomycin Group|please see study description for study enrollment
369854|NCT00401960|O2|Outcome|Standard of Care|Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician
369855|NCT00401960|O1|Outcome|Daptomycin Adjunctive Group|"Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving
Daptomycin: daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis"
369856|NCT00401960|O2|Outcome|Standard of Care Group|as per study description
369857|NCT00401960|O1|Outcome|Adjunctive Daptomycin Group|please see study description for study enrollment
369858|NCT00401960|E2|Reported Event|Standard of Care Group|as per study description
369859|NCT00401960|E1|Reported Event|Adjunctive Daptomycin Group|please see study description for study enrollment
369860|NCT00407797|B1|Baseline|Pregabalin|150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
369861|NCT00407797|P1|Participant Flow|Pregabalin|150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
369862|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369863|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369864|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369865|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369866|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369869|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369870|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369871|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369872|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369873|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369874|NCT00407797|E1|Reported Event|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
369914|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369915|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369916|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370283|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
369883|NCT00407966|B1|Baseline|Arm A|Flavopiridol, ara-C, mitoxantrone
369884|NCT00407966|P1|Participant Flow|Arm A|Flavopiridol, ara-C, mitoxantrone
369885|NCT00407966|O1|Outcome|Arm A|Flavopiridol, ara-C, mitoxantrone
369886|NCT00407966|E1|Reported Event|Arm A|Flavopiridol, ara-C, mitoxantrone
369887|NCT00408070|B1|Baseline|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
369888|NCT00408070|P1|Participant Flow|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
369889|NCT00408070|O1|Outcome|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
369890|NCT00408070|E1|Reported Event|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
369891|NCT00408876|B5|Baseline|Total|Total of all reporting groups
369892|NCT00408876|B4|Baseline|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369893|NCT00408876|B3|Baseline|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369894|NCT00408876|B2|Baseline|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369895|NCT00408876|B1|Baseline|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369896|NCT00408876|P4|Participant Flow|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369897|NCT00408876|P3|Participant Flow|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369898|NCT00408876|P2|Participant Flow|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369899|NCT00408876|P1|Participant Flow|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369900|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369901|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369902|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369903|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369904|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369905|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369906|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369907|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369908|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369909|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369910|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369911|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369912|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369913|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370284|NCT00409344|O1|Outcome|Saline|This group will recive saline
369917|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369918|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369919|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369920|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369921|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369922|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369923|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369924|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369925|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369926|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369927|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369928|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369929|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369930|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369931|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369932|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369933|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369934|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369935|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369936|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369937|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369938|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369939|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369940|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369941|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369942|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369943|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369944|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369945|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369946|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369947|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369948|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369949|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369950|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369951|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369952|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369953|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369954|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369955|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369956|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369957|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369958|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369959|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369960|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369961|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369962|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369963|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369964|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
373867|NCT00420303|E2|Reported Event|Placebo|Subcutaneously once weekly
369965|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369966|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369967|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369968|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369969|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369970|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369971|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369972|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369973|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369974|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369975|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369976|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369977|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369978|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369979|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369980|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369981|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369982|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369983|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369984|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369985|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369986|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369987|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369988|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369989|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369990|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369991|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369992|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369993|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369994|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369995|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
369996|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
369997|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
369998|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
369999|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370000|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370001|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370002|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370003|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370004|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370005|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370006|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370007|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370008|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370009|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370010|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370011|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370012|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
374274|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
370013|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370014|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370015|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370016|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370017|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370018|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370019|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370020|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370021|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370022|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370023|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370024|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370025|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370026|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370027|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370028|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370029|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370030|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370031|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370032|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370033|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370034|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370035|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370036|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370037|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370038|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370039|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370040|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370041|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370042|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370043|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370044|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370045|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370046|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370047|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370048|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370049|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370050|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370051|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370052|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370053|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370054|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370055|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370056|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370057|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370058|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370059|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370060|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
374275|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
370061|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370062|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370063|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370064|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370065|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370066|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370067|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370068|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370069|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370070|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370071|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370072|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370073|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370074|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370075|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370076|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370077|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370078|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370079|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370080|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370081|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370082|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370083|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370084|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370085|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370086|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370087|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370088|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370089|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370090|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370091|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370092|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370093|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370094|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370095|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370096|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370097|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370098|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370099|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370100|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370101|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370102|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370103|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370104|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370105|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370106|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370107|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370108|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
374276|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
370109|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370110|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370111|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370112|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370113|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370114|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370115|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370116|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370117|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370118|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370119|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370120|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370121|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370122|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370123|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370124|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370125|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370126|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370127|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370128|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370129|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370130|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370131|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370132|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370133|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370134|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370135|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370136|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370137|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370138|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370139|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370140|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370141|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370142|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370143|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370144|NCT00408876|E4|Reported Event|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
370145|NCT00408876|E3|Reported Event|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
370146|NCT00408876|E2|Reported Event|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
370147|NCT00408876|E1|Reported Event|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
370148|NCT00408902|B1|Baseline|TandutinibTreatment|Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
370149|NCT00408902|P1|Participant Flow|TandutinibTreatment|Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
370150|NCT00408902|O1|Outcome|TandutinibTreatment|Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
370151|NCT00408902|O1|Outcome|TandutinibTreatment|Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
370152|NCT00408902|E1|Reported Event|TandutinibTreatment|"Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
tandutinib: Given orally
laboratory biomarker analysis: Correlative studies"
370224|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
374277|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
370153|NCT00408928|B1|Baseline|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
370154|NCT00408928|P1|Participant Flow|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
370155|NCT00408928|O1|Outcome|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
370156|NCT00408928|O1|Outcome|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
370157|NCT00408928|E1|Reported Event|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
370158|NCT00408993|B3|Baseline|Total|Total of all reporting groups
370159|NCT00408993|B2|Baseline|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370160|NCT00408993|B1|Baseline|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370161|NCT00408993|P2|Participant Flow|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370162|NCT00408993|P1|Participant Flow|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370163|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370164|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370165|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370166|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370168|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370169|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370170|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370171|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370172|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370173|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370174|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370175|NCT00408993|O4|Outcome|Placebo - Evening Dosing|Placebo QD, PO for 12 weeks
370176|NCT00408993|O3|Outcome|Placebo - Morning Dosing|Placebo QD, PO for 12 weeks
370177|NCT00408993|O2|Outcome|Duloxetine - Evening Dosing|60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370178|NCT00408993|O1|Outcome|Duloxetine - Morning Dosing|60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370179|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370180|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370181|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370182|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370183|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370184|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370185|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370186|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370187|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370188|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370189|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
370190|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
370191|NCT00408993|E2|Reported Event|Duloxetine 60/120 mg QD|Duloxetine 60/120 mg QD
370192|NCT00408993|E1|Reported Event|Placebo|Placebo
370193|NCT00409006|B3|Baseline|Total|Total of all reporting groups
370194|NCT00409006|B2|Baseline|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
370225|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370226|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370195|NCT00409006|B1|Baseline|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
370196|NCT00409006|P2|Participant Flow|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
370197|NCT00409006|P1|Participant Flow|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
370198|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
370199|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
370200|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
370201|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
370471|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370202|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
370203|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
370204|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
370205|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
370206|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
370207|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
370208|NCT00409006|E2|Reported Event|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
370209|NCT00409006|E1|Reported Event|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
370210|NCT00409175|B3|Baseline|Total|Total of all reporting groups
370211|NCT00409175|B2|Baseline|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370212|NCT00409175|B1|Baseline|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370213|NCT00409175|P2|Participant Flow|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370214|NCT00409175|P1|Participant Flow|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370215|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370216|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370217|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370218|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370219|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370220|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370221|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370222|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370223|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370228|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370229|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370230|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370231|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370232|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370233|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370234|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370235|NCT00409175|E2|Reported Event|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
370236|NCT00409175|E1|Reported Event|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
370237|NCT00409188|B3|Baseline|Total|Total of all reporting groups
370238|NCT00409188|B2|Baseline|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
370239|NCT00409188|B1|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
370472|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
375519|NCT00425100|O1|Outcome|Open Label Baseline|
370240|NCT00409188|P2|Participant Flow|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
370241|NCT00409188|P1|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
370242|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
370243|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
370244|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
370245|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
370246|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
370247|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
370248|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
370285|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
370286|NCT00409344|O1|Outcome|Saline|This group will recive saline
370287|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
370288|NCT00409344|O1|Outcome|Saline|This group will recive saline
370249|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
370250|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
370251|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
370252|NCT00409188|E2|Reported Event|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
370307|NCT00409539|B3|Baseline|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370253|NCT00409188|E1|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
370254|NCT00409240|B3|Baseline|Total|Total of all reporting groups
370255|NCT00409240|B2|Baseline|Usual Care|Patient continued on usual care
370256|NCT00409240|B1|Baseline|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
370257|NCT00409240|P2|Participant Flow|Usual Care|Patient continued on usual care
370258|NCT00409240|P1|Participant Flow|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
370259|NCT00409240|O2|Outcome|Usual Care|Patient continued on usual care
370260|NCT00409240|O1|Outcome|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
370261|NCT00409240|E2|Reported Event|Usual Care|Patient continued on usual care
370262|NCT00409240|E1|Reported Event|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
370263|NCT00409292|B1|Baseline|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
370264|NCT00409292|P1|Participant Flow|RAD001|"RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.
Four weeks of study drug was considered to be one cycle of treatment."
370265|NCT00409292|O1|Outcome|RAD001|"RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.
Four weeks of study drug was considered to be one cycle of treatment.
RAD001: Taken orally daily for as long as the participant continues to receive a benefit."
370266|NCT00409292|O1|Outcome|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
370267|NCT00409292|O1|Outcome|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
370268|NCT00409292|O1|Outcome|RAD001|RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.
370269|NCT00409292|E1|Reported Event|RAD001|
370270|NCT00409331|B1|Baseline|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
370271|NCT00409331|P1|Participant Flow|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
370272|NCT00409331|O1|Outcome|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
370273|NCT00409331|E1|Reported Event|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
370274|NCT00409344|B3|Baseline|Total|Total of all reporting groups
370275|NCT00409344|B2|Baseline|Dexmedetomidine|This group will receive dexmedetomidine
370276|NCT00409344|B1|Baseline|Saline|This group will recive saline
370277|NCT00409344|P2|Participant Flow|Dexmedetomidine|This group will receive dexmedetomidine
370278|NCT00409344|P1|Participant Flow|Saline|This group will recive saline
370279|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
370280|NCT00409344|O1|Outcome|Saline|This group will recive saline
370281|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
370289|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
370290|NCT00409344|O1|Outcome|Saline|This group will recive saline
370291|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
370292|NCT00409344|O1|Outcome|Saline|This group will recive saline
370293|NCT00409344|E2|Reported Event|Dexmedetomidine|This group will receive dexmedetomidine
370294|NCT00409344|E1|Reported Event|Saline|This group will recive saline
370295|NCT00409409|B3|Baseline|Total|Total of all reporting groups
370296|NCT00409409|B2|Baseline|Placebo|Placebo tablet
370297|NCT00409409|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
370298|NCT00409409|P2|Participant Flow|Placebo|Placebo tablet
370299|NCT00409409|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
370300|NCT00409409|O2|Outcome|Placebo|Placebo tablet
370301|NCT00409409|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
370302|NCT00409409|E2|Reported Event|Placebo|Placebo tablet
370303|NCT00409409|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
370304|NCT00409539|B6|Baseline|Total|Total of all reporting groups
370305|NCT00409539|B5|Baseline|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370306|NCT00409539|B4|Baseline|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370308|NCT00409539|B2|Baseline|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370309|NCT00409539|B1|Baseline|Placebo|"Placebo run-in phase. 2 week duration.
Placebo: Placebo, 2 week duration."
370310|NCT00409539|P5|Participant Flow|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370311|NCT00409539|P4|Participant Flow|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370312|NCT00409539|P3|Participant Flow|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370313|NCT00409539|P2|Participant Flow|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370314|NCT00409539|P1|Participant Flow|Placebo|"Placebo run-in phase. 2 week duration.
Placebo: Placebo, 2 week duration."
370315|NCT00409539|O5|Outcome|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370316|NCT00409539|O4|Outcome|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370317|NCT00409539|O3|Outcome|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370318|NCT00409539|O2|Outcome|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370319|NCT00409539|O1|Outcome|Placebo|"Placebo run-in phase. 2 week duration.
Placebo: Placebo, 2 week duration."
370320|NCT00409539|O5|Outcome|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370321|NCT00409539|O4|Outcome|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370322|NCT00409539|O3|Outcome|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370323|NCT00409539|O2|Outcome|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370324|NCT00409539|O1|Outcome|Placebo|"Placebo run-in phase. 2 week duration.
Placebo: Placebo, 2 week duration."
370325|NCT00409539|E5|Reported Event|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370326|NCT00409539|E4|Reported Event|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370327|NCT00409539|E3|Reported Event|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370443|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370328|NCT00409539|E2|Reported Event|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
370329|NCT00409539|E1|Reported Event|Placebo|"Placebo run-in phase. 2 week duration.
Placebo: Placebo, 2 week duration."
370330|NCT00409565|B1|Baseline|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
370331|NCT00409565|P1|Participant Flow|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
370332|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
370333|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
370334|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
370335|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
370336|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
370337|NCT00409565|E1|Reported Event|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab
Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
370338|NCT00409578|B5|Baseline|Total|Total of all reporting groups
370339|NCT00409578|B4|Baseline|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370340|NCT00409578|B3|Baseline|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
370341|NCT00409578|B2|Baseline|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370342|NCT00409578|B1|Baseline|Placebo|Placebo tablets and capsules
370343|NCT00409578|P4|Participant Flow|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370344|NCT00409578|P3|Participant Flow|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
370345|NCT00409578|P2|Participant Flow|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370346|NCT00409578|P1|Participant Flow|Placebo|Placebo tablets and capsules
370347|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370348|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
370349|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370350|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
370444|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370445|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370446|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370351|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370352|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
370353|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370354|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
370355|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370356|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
370357|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370358|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
375520|NCT00425100|O1|Outcome|Open Label Week 12|
370359|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370360|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
370361|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370362|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
370363|NCT00409578|E4|Reported Event|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370364|NCT00409578|E3|Reported Event|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
370365|NCT00409578|E2|Reported Event|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
370366|NCT00409578|E1|Reported Event|Placebo|Placebo tablets and capsules
370367|NCT00409617|B1|Baseline|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370368|NCT00409617|P1|Participant Flow|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370369|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370370|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370447|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370448|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370371|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370372|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370373|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370464|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370465|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370374|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370375|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370376|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370377|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370378|NCT00409617|E1|Reported Event|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
370379|NCT00409682|B4|Baseline|Total|Total of all reporting groups
370380|NCT00409682|B3|Baseline|Low-Dose Adalimumab: 20 mg or 10 mg (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
370381|NCT00409682|B2|Baseline|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
370382|NCT00409682|B1|Baseline|Open-label Adalimumab (Week 0 to Week 4)|All subjects received an open-label adalimumab induction regimen. Subjects weighing greater than or equal to 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing less than 40 kg at Baseline received 80 mg at Week 0 and 40mg at Week 2.
370449|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370450|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
374278|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
370383|NCT00409682|P3|Participant Flow|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 20 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
370384|NCT00409682|P2|Participant Flow|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 10 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
370385|NCT00409682|P1|Participant Flow|Open-label Adalimumab (Week 0 to Week 4)|All subjects received an open-label adalimumab induction regimen. Subjects weighing ≥ 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing < 40 kg at Baseline received 80 mg at Week 0 and 40 mg at Week 2.
370466|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370467|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
375521|NCT00425100|O2|Outcome|Open Label Week 12|
370386|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
370387|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
370388|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
370389|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
370390|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
370391|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
370392|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
370393|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
370451|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370452|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370394|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
370395|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
370468|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370469|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370396|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
370397|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
370398|NCT00409682|E3|Reported Event|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|
370399|NCT00409682|E2|Reported Event|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|
370400|NCT00409682|E1|Reported Event|Open-label Adalimumab (Week 0 to Week 4)|
370401|NCT00409708|B3|Baseline|Total|Total of all reporting groups
370402|NCT00409708|B2|Baseline|Behavior Therapy|0 mg/day Ritalin LA
370403|NCT00409708|B1|Baseline|Ritalin LA Plus Behavior Therapy|10-60 mg/day
370404|NCT00409708|P2|Participant Flow|Behavior Therapy|0 mg/day Ritalin LA
370405|NCT00409708|P1|Participant Flow|Ritalin LA Plus Behavior Therapy|10-60 mg/day
370406|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
370407|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
370408|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
370409|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
370410|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
370411|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
370412|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
370413|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
370414|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
370415|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
370416|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
370417|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
370418|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
370419|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
370420|NCT00409708|E2|Reported Event|Behavior|Behavior
370421|NCT00409708|E1|Reported Event|Ritalin+Behavior|Ritalin+Behavior
370422|NCT00409747|B1|Baseline|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
370423|NCT00409747|P1|Participant Flow|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
370424|NCT00409747|O1|Outcome|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
370425|NCT00409747|O1|Outcome|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
370426|NCT00409747|E1|Reported Event|Overall Study/Minocycline|
370427|NCT00409773|B6|Baseline|Total|Total of all reporting groups
370428|NCT00409773|B5|Baseline|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370429|NCT00409773|B4|Baseline|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370430|NCT00409773|B3|Baseline|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370431|NCT00409773|B2|Baseline|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370432|NCT00409773|B1|Baseline|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370433|NCT00409773|P5|Participant Flow|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370434|NCT00409773|P4|Participant Flow|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370435|NCT00409773|P3|Participant Flow|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370436|NCT00409773|P2|Participant Flow|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370437|NCT00409773|P1|Participant Flow|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370438|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370439|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370440|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370441|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370442|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370453|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370454|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370455|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370456|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370457|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370458|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370459|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370460|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370461|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370462|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370463|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
375522|NCT00425100|O1|Outcome|Open Label Baseline|
370474|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370475|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370476|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370477|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370478|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370479|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370480|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370481|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370482|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370483|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370484|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370485|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370486|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370487|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370488|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370489|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370490|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370491|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370492|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370493|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370494|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370495|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370496|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370497|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370498|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370499|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370500|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370501|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370502|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370503|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370504|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370505|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370506|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370507|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370508|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370509|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370510|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370511|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370512|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370513|NCT00409773|E5|Reported Event|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
370514|NCT00409773|E4|Reported Event|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
370515|NCT00409773|E3|Reported Event|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
370516|NCT00409773|E2|Reported Event|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
370517|NCT00409773|E1|Reported Event|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
370518|NCT00409786|B1|Baseline|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
370519|NCT00409786|P1|Participant Flow|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
370520|NCT00409786|O1|Outcome|Group 1|All participants
370521|NCT00409786|E1|Reported Event|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
370522|NCT00409825|B1|Baseline|AUC1 vs AUC2|"AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.
AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection."
370523|NCT00409825|P1|Participant Flow|AUC1 vs AUC2|"AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.
AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection."
370524|NCT00409825|O1|Outcome|Part 1|Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection.
370525|NCT00409825|E1|Reported Event|Part 1|Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection. A subject in whom Part 2 is performed during the last scheduled injection of 17-OHPC (at or around 35 0/7 weeks) will have the option to participate in Part 4, in which 10 cc of blood will be drawn serially over 21 days after completing Part 2. Blood will be drawn on days 9, 11, 14, 17, 20, 24, 28 after the last injection. Part 3: At the time of labor and delivery, subject will have 10cc of blood removed from a maternal peripheral vein. 10cc of blood will be collected from the placenta/umbilical cord after delivery.
370526|NCT00409838|B3|Baseline|Total|Total of all reporting groups
370527|NCT00409838|B2|Baseline|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370528|NCT00409838|B1|Baseline|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370529|NCT00409838|P2|Participant Flow|Placebo|Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).
370530|NCT00409838|P1|Participant Flow|Abatacept, 10 mg/kg|"Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).
Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg."
370531|NCT00409838|O2|Outcome|Placebo|Short-term Period. Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370532|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370533|NCT00409838|O2|Outcome|Placebo|Short-term Period. Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370534|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370535|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370536|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370537|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370538|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370539|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370540|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370541|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370542|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370543|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370698|NCT00410150|P1|Participant Flow|Heliox Group|Patients randomized to the Heliox arm of the study
370544|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370545|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370546|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
370547|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
370548|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Abatacept administered IV in a body-weight tiered dose approximating 10 mg/kg. Study medication was administered on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
370549|NCT00409838|O1|Outcome|All Treated|Abatacept was administered intravenously monthly at a fixed dose of approximately 10 mg/kg in the LTE period on a background of methotrexate
370550|NCT00409838|O1|Outcome|All Treated|Abatacept, administered intravenously IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months in the LTE period on a background of methotrexate
370551|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370552|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370553|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370554|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370555|NCT00409838|O1|Outcome|Abatacept + Background Methotrexate|Dosage: 500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370556|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
370557|NCT00409838|O2|Outcome|Abatacept 750 mg|
370558|NCT00409838|O1|Outcome|Abatacept 500 mg|
370559|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
370560|NCT00409838|O2|Outcome|Abatacept 750 mg|
370561|NCT00409838|O1|Outcome|Abatacept 500 mg|
370562|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
370563|NCT00409838|O2|Outcome|Abatacept 750 mg|
370564|NCT00409838|O1|Outcome|Abatacept 500 mg|
370565|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
370566|NCT00409838|O2|Outcome|Abatacept 750 mg|
370567|NCT00409838|O1|Outcome|Abatacept 500 mg|
370568|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
370569|NCT00409838|O2|Outcome|Abatacept 750 mg|
370570|NCT00409838|O1|Outcome|Abatacept 500 mg|
370571|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
370572|NCT00409838|O2|Outcome|Abatacept 750 mg|
370573|NCT00409838|O1|Outcome|Abatacept 500 mg|
370574|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370575|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370576|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370577|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370578|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370579|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370580|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370581|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370582|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370583|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370584|NCT00409838|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
370585|NCT00409838|O1|Outcome|Abatacept|Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
370586|NCT00409838|O2|Outcome|Placebo|Participants received placebo IV on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
370587|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
370588|NCT00409838|E2|Reported Event|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370589|NCT00409838|E1|Reported Event|Abatacept 10 mg/kg|500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
370590|NCT00410046|B1|Baseline|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370591|NCT00410046|P1|Participant Flow|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370592|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370593|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370594|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370595|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370596|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370597|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370598|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370599|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370600|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370601|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370602|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
374279|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
370603|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370604|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370605|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370606|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370607|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370608|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370609|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370610|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370611|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370699|NCT00410150|O2|Outcome|Control Group|Subjects randomized to the control arm of the study
370612|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370613|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370614|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370615|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370616|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370617|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370618|NCT00410046|E1|Reported Event|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
370619|NCT00410059|B1|Baseline|Erlotinib|150 mg orally day for 28 days.
370620|NCT00410059|P1|Participant Flow|Erlotinib|150 mg orally day for 28 days.
370621|NCT00410059|O1|Outcome|Erlotinib|150 mg orally day for 28 days.
370622|NCT00410059|E1|Reported Event|Erlotinib|150 mg orally day for 28 days.
370623|NCT00410072|B3|Baseline|Total|Total of all reporting groups
370624|NCT00410072|B2|Baseline|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370625|NCT00410072|B1|Baseline|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370626|NCT00410072|P2|Participant Flow|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370627|NCT00410072|P1|Participant Flow|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370628|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370629|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370630|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370631|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370632|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370633|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370634|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370635|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370636|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370637|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370638|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370639|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370640|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370641|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370642|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370643|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370644|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370645|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370646|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370647|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370648|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370649|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370650|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370651|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370652|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370653|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370654|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370655|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370656|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370657|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370658|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
370659|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
370660|NCT00410072|E2|Reported Event|ETV/TDF 0.5 mg +TDF 300 mg|ETV 0.5 mg plus TDF 300 mg combination therapy given once daily (QD) for 100 weeks
370663|NCT00410124|B2|Baseline|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370664|NCT00410124|B1|Baseline|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370665|NCT00410124|P2|Participant Flow|Placebo + BSC / RAD001|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370666|NCT00410124|P1|Participant Flow|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370667|NCT00410124|O1|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
370668|NCT00410124|O1|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
370669|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
370670|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
370671|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
370672|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
370673|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
370674|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
370675|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
370676|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
370769|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370867|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
374280|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
370677|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370678|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370679|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370680|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370700|NCT00410150|O1|Outcome|Heliox Group|Patients randomized to the Heliox arm of the study
370701|NCT00410150|E2|Reported Event|Control Group|Subjects randomized to the control arm of the study
370681|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370682|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370683|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370684|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370685|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370686|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370687|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370688|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370689|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370714|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370866|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370690|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370691|NCT00410124|E3|Reported Event|Randomized to Placebo + BSC (Double Blind Only)|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care.
370692|NCT00410124|E2|Reported Event|Randomized to Placebo + BSC (Open Label)|With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370693|NCT00410124|E1|Reported Event|Randomized to RAD001+ BSC ( Blinded + Open Label)|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
370694|NCT00410150|B3|Baseline|Total|Total of all reporting groups
370695|NCT00410150|B2|Baseline|Control Group|Subjects randomized to the control arm of the study
370696|NCT00410150|B1|Baseline|Heliox Group|Patients randomized to the Heliox arm of the study
370702|NCT00410150|E1|Reported Event|Heliox Group|Patients randomized to the Heliox arm of the study
370703|NCT00410163|B3|Baseline|Total|Total of all reporting groups
370704|NCT00410163|B2|Baseline|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370705|NCT00410163|B1|Baseline|Ofatumumab 500 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370706|NCT00410163|P2|Participant Flow|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses. After the last infusion, the disease status of the participants was evaluated every 3 months up to 18 months during the Follow-up Period. Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative CLL therapy was initiated, or until Month 60.
370707|NCT00410163|P1|Participant Flow|Ofatumumab 500 mg + Fludarabine and Cyclophosphamide (FC)|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses. After the last infusion, the disease status of the participants was evaluated every 3 months up to 18 months during the Follow-up Period. Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative Chronic Lymphocyte Leukemia (CLL) therapy was initiated, or until Month 60.
370708|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370709|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370710|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370711|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370712|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370713|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370767|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
370715|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370716|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370717|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370718|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370719|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370720|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370721|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370886|NCT00410384|P3|Participant Flow|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370722|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370723|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370724|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370725|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370726|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370727|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370728|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370729|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370730|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370731|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370732|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370733|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370734|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370735|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370736|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370737|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370738|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370739|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370740|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370741|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370742|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370743|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370744|NCT00410163|E4|Reported Event|Ofatumumab 1000 mg + FC: Extended Follow-up Phase|Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative CLL therapy was initiated, or until Month 60.
370745|NCT00410163|E3|Reported Event|Ofatumumab 500 mg + FC: Extended Follow-up Phase|Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative Chronic Lymphocyte Leukemia (CLL) therapy was initiated, or until Month 60.
370746|NCT00410163|E2|Reported Event|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370747|NCT00410163|E1|Reported Event|Ofatumumab 500 mg + Fludarabine and Cyclophosphamide (FC)|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
370748|NCT00410189|B1|Baseline|ZD6474|ZD6474 300 mg by mouth daily.
370749|NCT00410189|P1|Participant Flow|ZD6474|ZD6474 300 mg by mouth daily.
370750|NCT00410189|O1|Outcome|ZD6474|ZD6474 300 mg by mouth daily.
370751|NCT00410189|O1|Outcome|ZD6474|ZD6474 300 mg by mouth daily.
370752|NCT00410189|E1|Reported Event|ZD6474|ZD6474 300 mg by mouth daily.
370753|NCT00410202|B4|Baseline|Total|Total of all reporting groups
370754|NCT00410202|B3|Baseline|Adefovir + Lamivudine (ADV+LVD) Combination Therapy|ADV 10 mg + LVD 100 mg; Combination therapy given QD for 100 weeks
370755|NCT00410202|B2|Baseline|Entecavir (ETV) Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370756|NCT00410202|B1|Baseline|Entecavir + Adefovir (ETV+ADV) Combination Therapy|ETV 1.0 mg + ADV 10 mg; Combination therapy given once daily (QD) for 100 weeks
370757|NCT00410202|P3|Participant Flow|Adefovir + Lamivudine (ADV+LVD) Combination Therapy|ADV 10 mg + LVD 100 mg; Combination therapy given QD for 100 weeks
370758|NCT00410202|P2|Participant Flow|Entecavir (ETV) Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370759|NCT00410202|P1|Participant Flow|Entecavir + Adefovir (ETV+ADV) Combination Therapy|ETV 1.0 mg + ADV 10 mg; Combination therapy given once daily (QD) for 100 weeks
370760|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370761|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370762|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
370763|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370764|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
370765|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
370766|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370768|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
370770|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370771|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370772|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370773|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370774|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370775|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370776|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
370777|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370778|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370779|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
370780|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370781|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370782|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370783|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370784|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
371284|NCT00404924|B1|Baseline|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
370785|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
370786|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370787|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370788|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370789|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370790|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370791|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370792|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370793|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370794|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370795|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370796|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370797|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370798|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370799|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370800|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370801|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370802|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370803|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
370804|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370805|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370806|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370807|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370808|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370809|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370810|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370811|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370812|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370813|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370814|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370815|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370816|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370817|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370818|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370819|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370820|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370821|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370822|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370823|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370824|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370825|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370826|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370827|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370828|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370829|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370830|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370831|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370832|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370833|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370834|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370835|NCT00410202|E3|Reported Event|ETV + ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
370836|NCT00410202|E2|Reported Event|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
370837|NCT00410202|E1|Reported Event|ADV + LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
370838|NCT00410280|B3|Baseline|Total|Total of all reporting groups
370839|NCT00410280|B2|Baseline|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370840|NCT00410280|B1|Baseline|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370841|NCT00410280|P2|Participant Flow|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370842|NCT00410280|P1|Participant Flow|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370843|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370844|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370845|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370846|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370847|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370848|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370849|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370850|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370851|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370852|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370853|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370854|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370855|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370856|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370857|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370858|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370859|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370860|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370861|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370862|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370863|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370864|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370865|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370868|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370869|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370870|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370871|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370872|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370873|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370874|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370875|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370876|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370877|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370878|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370879|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370880|NCT00410280|E2|Reported Event|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
370881|NCT00410280|E1|Reported Event|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
370882|NCT00410384|B4|Baseline|Total|Total of all reporting groups
370883|NCT00410384|B3|Baseline|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370884|NCT00410384|B2|Baseline|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370885|NCT00410384|B1|Baseline|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370887|NCT00410384|P2|Participant Flow|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370888|NCT00410384|P1|Participant Flow|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370889|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370890|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370891|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370892|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370893|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370894|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370895|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370896|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370897|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370898|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370899|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370900|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370901|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370902|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370903|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370904|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370905|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370906|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370907|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370908|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370909|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370910|NCT00410384|E3|Reported Event|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
374281|NCT00421174|E2|Reported Event|Placebo|Placebo plus Corticosteroids
370911|NCT00410384|E2|Reported Event|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370912|NCT00410384|E1|Reported Event|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
370913|NCT00410410|B7|Baseline|Total|Total of all reporting groups
370914|NCT00410410|B6|Baseline|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
370915|NCT00410410|B5|Baseline|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
370916|NCT00410410|B4|Baseline|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
370917|NCT00410410|B3|Baseline|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
370918|NCT00410410|B2|Baseline|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
370919|NCT00410410|B1|Baseline|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
370920|NCT00410410|P9|Participant Flow|ABA ~10 mg/kg, Open-Label Period (OL)|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
370921|NCT00410410|P8|Participant Flow|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370922|NCT00410410|P7|Participant Flow|ABA ~10 mg/kg, Maintenance Period (MP)|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370923|NCT00410410|P6|Participant Flow|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
370963|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370924|NCT00410410|P5|Participant Flow|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370925|NCT00410410|P4|Participant Flow|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
370926|NCT00410410|P3|Participant Flow|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
370927|NCT00410410|P2|Participant Flow|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
370928|NCT00410410|P1|Participant Flow|Induction Period Cohort 1 (IP1C)-Abatacept (ABA) 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370929|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
370930|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
370931|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
370932|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370933|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370934|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370935|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370936|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370937|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
370938|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
370939|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370940|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370941|NCT00410410|O2|Outcome|ABA ~10 mg/kg, MP|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370942|NCT00410410|O1|Outcome|ABA 30/~10 mg/kg, MP|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
370943|NCT00410410|O2|Outcome|ABA ~10 mg/kg, MP|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370944|NCT00410410|O1|Outcome|ABA 30/~10 mg/kg, MP|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
370945|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370946|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370947|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370948|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370949|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370950|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370951|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370952|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370953|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370954|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370955|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370956|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370957|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370958|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370959|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370960|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370961|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370962|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370964|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370965|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370966|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370967|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370968|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370969|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370970|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370971|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370972|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370973|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370974|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370975|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370976|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370977|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
370978|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
370979|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
370980|NCT00410410|O2|Outcome|IP1C+IP2C: ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370981|NCT00410410|O1|Outcome|IP1C+IP2C: ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
370982|NCT00410410|O2|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370983|NCT00410410|O1|Outcome|IP2C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
370984|NCT00410410|O2|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370985|NCT00410410|O1|Outcome|IP2C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
370986|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
370987|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
371115|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
374341|NCT00412061|B3|Baseline|Total|Total of all reporting groups
370988|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370989|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
370990|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
370991|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
370992|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370993|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
370994|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
370995|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
370996|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370997|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
371066|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
370998|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
370999|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371000|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371001|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
371002|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371003|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
371004|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371005|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371006|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371007|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
371008|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371009|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
371010|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371011|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371012|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371013|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
371014|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371015|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
371016|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371017|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
371018|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
371116|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371019|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371020|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
371021|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
371022|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371023|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
371024|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
371025|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371026|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
371027|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
371028|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371029|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
371030|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
371285|NCT00404924|P2|Participant Flow|Placebo|Placebo plus best supportive care
371031|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371032|NCT00410410|O4|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
371033|NCT00410410|O3|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371034|NCT00410410|O2|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
371035|NCT00410410|O1|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371036|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371037|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
371038|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
371039|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371040|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371041|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
371042|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
371043|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371044|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371045|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
371046|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
371047|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371048|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371049|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
371050|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
371051|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371052|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371053|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
371054|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
374655|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
371055|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
371056|NCT00410410|O4|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
371057|NCT00410410|O3|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371058|NCT00410410|O2|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
371059|NCT00410410|O1|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371060|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371061|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
371062|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
371063|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371064|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371065|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
371067|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371068|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371069|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
371070|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371071|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
371072|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371073|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
371074|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
371075|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371076|NCT00410410|E9|Reported Event|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
371077|NCT00410410|E8|Reported Event|Placebo, IP1C|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
371078|NCT00410410|E7|Reported Event|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
371079|NCT00410410|E6|Reported Event|ABA ~10mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
371080|NCT00410410|E5|Reported Event|ABA ~10mg/kg,IP2C|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
371081|NCT00410410|E4|Reported Event|ABA ~10 mg/kg,IP1C|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
371082|NCT00410410|E3|Reported Event|ABA 3 mg/kg,IP1C|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
371083|NCT00410410|E2|Reported Event|ABA 30/~10mg/kg,IP2C|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg.
371084|NCT00410410|E1|Reported Event|ABA 30/~10 mg/kg,IP1C|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
371085|NCT00410488|B3|Baseline|Total|Total of all reporting groups
371086|NCT00410488|B2|Baseline|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
371117|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371118|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
372190|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
371087|NCT00410488|B1|Baseline|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
371088|NCT00410488|P2|Participant Flow|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
371089|NCT00410488|P1|Participant Flow|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
371134|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371135|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371090|NCT00410488|O2|Outcome|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
371091|NCT00410488|O1|Outcome|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
371092|NCT00410488|E1|Reported Event|Palonosetron|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0) and Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
371093|NCT00410514|B4|Baseline|Total|Total of all reporting groups
371094|NCT00410514|B3|Baseline|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371095|NCT00410514|B2|Baseline|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371096|NCT00410514|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371097|NCT00410514|P3|Participant Flow|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371098|NCT00410514|P2|Participant Flow|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371099|NCT00410514|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371100|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371101|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371102|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371103|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371104|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371105|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371106|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371107|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371108|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371109|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371110|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371111|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371112|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371113|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371114|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371119|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371120|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371121|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371122|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371123|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371124|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371125|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371126|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371127|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371128|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371129|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371130|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371131|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371132|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371133|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371136|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371137|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371138|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371139|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371140|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371141|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371142|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371143|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371144|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371145|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371146|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371147|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371148|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371149|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371150|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371151|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371152|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371153|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371154|NCT00410514|E3|Reported Event|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
371155|NCT00410514|E2|Reported Event|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
371156|NCT00410514|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
371157|NCT00410761|B3|Baseline|Total|Total of all reporting groups
371158|NCT00410761|B2|Baseline|Placebo|Placebo daily
371159|NCT00410761|B1|Baseline|Vandetanib 300 mg|Vandetanib (300 mg daily)
371160|NCT00410761|P2|Participant Flow|Placebo|Placebo daily
371161|NCT00410761|P1|Participant Flow|Vandetanib 300 mg|Vandetanib (300 mg daily)
371162|NCT00410761|O2|Outcome|Placebo|Placebo daily
371163|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
371164|NCT00410761|O2|Outcome|Placebo|Placebo daily
371165|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
371166|NCT00410761|O2|Outcome|Placebo|Placebo daily
371167|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
371168|NCT00410761|O2|Outcome|Placebo|Placebo daily
371169|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
371170|NCT00410761|O2|Outcome|Placebo|Placebo daily
371171|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
371172|NCT00410761|O2|Outcome|Placebo|Placebo daily
371173|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
371174|NCT00410761|O2|Outcome|Placebo|Placebo daily
371175|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
371176|NCT00410761|O2|Outcome|Placebo|Placebo daily
371177|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
371178|NCT00410761|E2|Reported Event|Placebo|Placebo daily
371179|NCT00410761|E1|Reported Event|Vandetanib 300 mg|Vandetanib (300 mg daily)
371181|NCT00410813|B2|Baseline|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
371182|NCT00410813|B1|Baseline|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
371183|NCT00410813|P2|Participant Flow|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
371184|NCT00410813|P1|Participant Flow|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
371185|NCT00410813|O4|Outcome|Dasatinib - Week 24|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
371186|NCT00410813|O3|Outcome|Dasatinib - Week 16|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
371187|NCT00410813|O2|Outcome|Dasatinib - Week 8|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
371188|NCT00410813|O1|Outcome|Dasatinib - Baseline|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
371189|NCT00410813|O2|Outcome|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
371190|NCT00410813|O1|Outcome|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
371191|NCT00410813|O3|Outcome|TRAP at 8 Weeks|
371192|NCT00410813|O2|Outcome|TRAP at 4 Weeks|
371193|NCT00410813|O1|Outcome|TRAP at Baseline|
371194|NCT00410813|O3|Outcome|OPG at 8 Weeks|
371195|NCT00410813|O2|Outcome|OPG at 4 Weeks|
371196|NCT00410813|O1|Outcome|OPG at Baseline|
371197|NCT00410813|O3|Outcome|OC at 8 Weeks|
371198|NCT00410813|O2|Outcome|OC at 4 Weeks|
371199|NCT00410813|O1|Outcome|OC at Baseline|
371200|NCT00410813|O3|Outcome|Serum Biomarker at 8 Weeks|
371201|NCT00410813|O2|Outcome|Serum Biomarker at 4 Weeks|
371202|NCT00410813|O1|Outcome|Serum Biomarker at Baseline|
371203|NCT00410813|O3|Outcome|BAP at 8 Weeks|
371204|NCT00410813|O2|Outcome|BAP at 4 Weeks|
371209|NCT00410813|O1|Outcome|Dasatinib|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
371210|NCT00410813|O2|Outcome|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
371211|NCT00410813|O1|Outcome|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
371212|NCT00410813|O2|Outcome|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
371213|NCT00410813|O1|Outcome|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
371214|NCT00410813|O2|Outcome|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
371215|NCT00410813|O1|Outcome|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
371216|NCT00410813|E2|Reported Event|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
371217|NCT00410813|E1|Reported Event|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
371218|NCT00410826|B3|Baseline|Total|Total of all reporting groups
371219|NCT00410826|B2|Baseline|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
371220|NCT00410826|B1|Baseline|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
371221|NCT00410826|P2|Participant Flow|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
371222|NCT00410826|P1|Participant Flow|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
371223|NCT00410826|O2|Outcome|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
371224|NCT00410826|O1|Outcome|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
371225|NCT00410826|O2|Outcome|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
371226|NCT00410826|O1|Outcome|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
371227|NCT00410826|E2|Reported Event|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
371228|NCT00410826|E1|Reported Event|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
371229|NCT00410891|B1|Baseline|Topical Antibiotic|"topical gatifloxacin 4 times per day
gatifloxacin"
371230|NCT00410891|P1|Participant Flow|Topical Antibiotic|"topical gatifloxacin 4 times per day
gatifloxacin"
371231|NCT00410891|O1|Outcome|Topical Antibiotic|"topical gatifloxacin 4 times per day
gatifloxacin"
371232|NCT00410891|E1|Reported Event|Topical Antibiotic|"topical gatifloxacin 4 times per day
gatifloxacin"
371233|NCT00410904|B3|Baseline|Total|Total of all reporting groups
371234|NCT00410904|B2|Baseline|Arm I Cohort B - Prior Bevacizumab (Avastin)|Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
371235|NCT00410904|B1|Baseline|Arm I Cohort A- No Prior Bevacizumab (Avastin)|Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
371236|NCT00410904|P2|Participant Flow|Arm I Cohort B- Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
371237|NCT00410904|P1|Participant Flow|Arm I Cohort A- No Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
371238|NCT00410904|O2|Outcome|Arm I - Cohort B, Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
371239|NCT00410904|O1|Outcome|Arm I - Cohort A, no Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
371240|NCT00410904|E2|Reported Event|Arm I - Cohort B|"This is a one arm study with two cohorts.
Cohort B: Prior bevacizumab before entering into this trial
Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
371241|NCT00410904|E1|Reported Event|Arm I - Cohort A|"This is a one arm study with two cohorts.
Cohort A: No prior bevacizumab before entering into this trial
Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
371242|NCT00411151|B1|Baseline|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
371243|NCT00411151|P1|Participant Flow|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
371244|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
371245|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
371246|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
371247|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
371248|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
371249|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
371250|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
371251|NCT00411151|E1|Reported Event|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
371252|NCT00411216|B3|Baseline|Total|Total of all reporting groups
371253|NCT00411216|B2|Baseline|Control Exercises|Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
371254|NCT00411216|B1|Baseline|Exercises for Gaze Stabilization|Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
371255|NCT00411216|P2|Participant Flow|Control Exercises|"Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
Control exercises: saccadic eye movements against a plain background; no head movements"
371256|NCT00411216|P1|Participant Flow|Exercises for Gaze Stabilization|"Experimental group performed vestibular adaptation and substitution exercises
gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements"
371257|NCT00411216|O2|Outcome|Control Exercises|"Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
Control exercises: saccadic eye movements against a plain background; no head movements"
371258|NCT00411216|O1|Outcome|Exercises for Gaze Stabilization|"Experimental group performed vestibular adaptation and substitution exercises
gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements"
371259|NCT00411216|E2|Reported Event|Control Exercises|Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
371260|NCT00411216|E1|Reported Event|Exercises for Gaze Stabilization|Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
371261|NCT00404820|B3|Baseline|Total|Total of all reporting groups
371432|NCT00411463|O2|Outcome|Medication|Patients taking Quetiapine (Seroquel) during 12 weeks of active treatment.
371262|NCT00404820|B2|Baseline|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371263|NCT00404820|B1|Baseline|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371264|NCT00404820|P2|Participant Flow|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371265|NCT00404820|P1|Participant Flow|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371266|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371286|NCT00404924|P1|Participant Flow|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
371287|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
371288|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
371289|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
371267|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371268|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371269|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371270|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371271|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371272|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371273|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371274|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371275|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371276|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371433|NCT00411463|O1|Outcome|Psychotherapy|Patients assigned to talk therapy (IPSRT) intervention during 12 weeks of active enrollment in study.
371277|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371278|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371279|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371280|NCT00404820|E2|Reported Event|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371281|NCT00404820|E1|Reported Event|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
371290|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
371291|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
371292|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
371293|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
371294|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
371295|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
371296|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
371297|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
371298|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
371299|NCT00404924|E2|Reported Event|Placebo|Placebo
371300|NCT00404924|E1|Reported Event|Vandetanib|Vandetanib 300 mg
371301|NCT00405067|B4|Baseline|Total|Total of all reporting groups
371302|NCT00405067|B3|Baseline|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371303|NCT00405067|B2|Baseline|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371304|NCT00405067|B1|Baseline|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371305|NCT00405067|P3|Participant Flow|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371306|NCT00405067|P2|Participant Flow|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371307|NCT00405067|P1|Participant Flow|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371308|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371309|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371310|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371311|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371312|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371313|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371314|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371461|NCT00411645|O1|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
375768|NCT00425698|B1|Baseline|Erythropoietin|
371315|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371316|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371317|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371318|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371319|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371320|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371321|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371322|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371323|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371324|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371325|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371326|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371327|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371328|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371329|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371330|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371331|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371332|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371333|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371334|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371335|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371336|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371337|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371338|NCT00405067|E3|Reported Event|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
371339|NCT00405067|E2|Reported Event|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371340|NCT00405067|E1|Reported Event|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
371341|NCT00405275|B3|Baseline|Total|Total of all reporting groups
371342|NCT00405275|B2|Baseline|Etanercept|Etanercept and Methotrexate
371343|NCT00405275|B1|Baseline|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
371344|NCT00405275|P2|Participant Flow|Etanercept|"Etanercept (50mg subcutaneous injections weekly); Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, triple: placebo hydroxychloroquine (tablets daily) and placebo sulfasalazine (tablets daily).
Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Triple. This is denoted in results table below as switch. No switch participants remained on Etanercept therapy throughout the trial."
371345|NCT00405275|P1|Participant Flow|Triple|"Hydroxychloroquine (400mg daily); Sulfasalazine (1g daily for 6 weeks, then increased to 2g daily; Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, etanercept (subcutaneous injection).
Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Etanercept at 24 weeks. This is denoted in results table below as switch. No switch participants remained on Triple therapy throughout the trial."
371346|NCT00405275|O2|Outcome|Etanercept|Etanercept and Methotrexate
371347|NCT00405275|O1|Outcome|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
371348|NCT00405275|E2|Reported Event|Etanercept|Etanercept and Methotrexate
371349|NCT00405275|E1|Reported Event|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
371351|NCT00405288|B2|Baseline|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371352|NCT00405288|B1|Baseline|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371353|NCT00405288|P2|Participant Flow|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371354|NCT00405288|P1|Participant Flow|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371355|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371356|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371357|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371358|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371359|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371360|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371361|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371362|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371363|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371364|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371365|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371366|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371367|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371368|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371369|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371370|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371371|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371372|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371373|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371374|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371375|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371376|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371377|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
371378|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371379|NCT00405288|E2|Reported Event|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
375769|NCT00425698|P2|Participant Flow|Placebo|
371380|NCT00405288|E1|Reported Event|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
371381|NCT00411398|B1|Baseline|Memantine|Memantine tablets
371382|NCT00411398|P1|Participant Flow|Memantine|Memantine tablets
371383|NCT00411398|O1|Outcome|Memantine|Memantine tablets
371384|NCT00411398|E1|Reported Event|Memantine|Memantine tablets
371385|NCT00411411|B3|Baseline|Total|Total of all reporting groups
371386|NCT00411411|B2|Baseline|Januvia|Active treatment
371387|NCT00411411|B1|Baseline|Placebo|Placebo treatment
371388|NCT00411411|P2|Participant Flow|Januvia|Active treatment
371389|NCT00411411|P1|Participant Flow|Placebo|Placebo treatment
371390|NCT00411411|O2|Outcome|Januvia|"Active treatment
Januvia: 200 mg t.i.d"
371391|NCT00411411|O1|Outcome|Placebo|"Placebo treatment, administered as tablets.
Placebo: Placebo"
371392|NCT00411411|O2|Outcome|Januvia|"Active treatment
Januvia: 200 mg t.i.d"
371393|NCT00411411|O1|Outcome|Placebo|Placebo: Placebo
371394|NCT00411411|E2|Reported Event|Januvia|Active treatment. No adverse events recorded
371395|NCT00411411|E1|Reported Event|Placebo|No adverse events recorded
371396|NCT00411450|B1|Baseline|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
371397|NCT00411450|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
371398|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
371399|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
371400|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371484|NCT00411671|P1|Participant Flow|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
371401|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371402|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371403|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371404|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371405|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371406|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371407|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371408|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371409|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371410|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371411|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371412|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371413|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371414|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371415|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371416|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371417|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371418|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
371419|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371420|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
371421|NCT00411450|E1|Reported Event|Panitumumab + FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
371422|NCT00411463|B3|Baseline|Total|Total of all reporting groups
371423|NCT00411463|B2|Baseline|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
371424|NCT00411463|B1|Baseline|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
371787|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371425|NCT00411463|P2|Participant Flow|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
371426|NCT00411463|P1|Participant Flow|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
371427|NCT00411463|O2|Outcome|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
371428|NCT00411463|O1|Outcome|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
371429|NCT00411463|O3|Outcome|Total|Total number of participants
371430|NCT00411463|O2|Outcome|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
371431|NCT00411463|O1|Outcome|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
371434|NCT00411463|O2|Outcome|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
371435|NCT00411463|O1|Outcome|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
371436|NCT00411463|E2|Reported Event|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
371437|NCT00411463|E1|Reported Event|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
371438|NCT00411554|B3|Baseline|Total|Total of all reporting groups
371439|NCT00411554|B2|Baseline|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
371440|NCT00411554|B1|Baseline|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
371441|NCT00411554|P2|Participant Flow|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
371442|NCT00411554|P1|Participant Flow|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
371443|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
371444|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
371445|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
371446|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
371447|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
371448|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
371449|NCT00411554|E2|Reported Event|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
371450|NCT00411554|E1|Reported Event|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
371451|NCT00411619|B1|Baseline|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
371452|NCT00411619|P1|Participant Flow|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
371453|NCT00411619|O1|Outcome|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
371454|NCT00411619|O1|Outcome|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus. The initial starting dose was to be 3.0 mg/m2/day taken either daily or every other day with titration to achieve target trough concentrations of 5 to 15 ng/mL, subject to tolerability. Study drug was self-administered orally (or administered by a caregiver) at the same time each day.
371455|NCT00411619|E1|Reported Event|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
371456|NCT00411645|B3|Baseline|Total|Total of all reporting groups
371457|NCT00411645|B2|Baseline|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371458|NCT00411645|B1|Baseline|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
371459|NCT00411645|P2|Participant Flow|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371460|NCT00411645|P1|Participant Flow|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
372278|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
371462|NCT00411645|O1|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371463|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371464|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
371465|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371466|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
371467|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371468|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
371469|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371470|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
371471|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371472|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
371473|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371474|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
371475|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371476|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
371477|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371478|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
371479|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371480|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
371481|NCT00411645|E2|Reported Event|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
371482|NCT00411645|E1|Reported Event|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
371483|NCT00411671|B1|Baseline|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
371485|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
371486|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
371487|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
371488|NCT00411671|E1|Reported Event|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
371489|NCT00412737|B3|Baseline|Total|Total of all reporting groups
371490|NCT00412737|B2|Baseline|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
371491|NCT00412737|B1|Baseline|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
371492|NCT00412737|P2|Participant Flow|Oseltamivir|Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.
371493|NCT00412737|P1|Participant Flow|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
371494|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
371495|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
371496|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
371497|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
371498|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
371499|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
371500|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
371501|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
371502|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
371503|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
371504|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
371505|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
371506|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
371507|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
371508|NCT00412737|E2|Reported Event|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
371509|NCT00412737|E1|Reported Event|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
371510|NCT00412750|B4|Baseline|Total|Total of all reporting groups
371511|NCT00412750|B3|Baseline|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
371512|NCT00412750|B2|Baseline|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
371513|NCT00412750|B1|Baseline|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
371514|NCT00412750|P3|Participant Flow|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
371515|NCT00412750|P2|Participant Flow|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
375770|NCT00425698|P1|Participant Flow|Erythropoietin|
371516|NCT00412750|P1|Participant Flow|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
371517|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
371518|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
371519|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
371520|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
371521|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
371522|NCT00412750|O2|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
371523|NCT00412750|O1|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
371524|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
371525|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
371526|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
371527|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
371528|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
371529|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
371530|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
371531|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
371532|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
375523|NCT00425100|O2|Outcome|Open Label Week 12|
371533|NCT00412750|O2|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
371534|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
371535|NCT00412750|E3|Reported Event|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
371536|NCT00412750|E2|Reported Event|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
371537|NCT00412750|E1|Reported Event|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
371538|NCT00412841|B3|Baseline|Total|Total of all reporting groups
371539|NCT00412841|B2|Baseline|Placebo|
371540|NCT00412841|B1|Baseline|Atorvastatin|Atorvastatin 40mg
371541|NCT00412841|P2|Participant Flow|Placebo|
371542|NCT00412841|P1|Participant Flow|Atorvastatin|40 mg
371543|NCT00412841|O2|Outcome|Placebo|
371544|NCT00412841|O1|Outcome|Atorvastatin|Atorvastatin 40mg
371545|NCT00412841|O2|Outcome|Placebo|
371546|NCT00412841|O1|Outcome|Atorvastatin|Atorvastatin 40mg
371547|NCT00412841|E2|Reported Event|Placebo|Placebo
371548|NCT00412841|E1|Reported Event|Atorvastatin|Atorvastatin 40mg
371549|NCT00412854|B3|Baseline|Total|Total of all reporting groups
371550|NCT00412854|B2|Baseline|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371551|NCT00412854|B1|Baseline|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371552|NCT00412854|P2|Participant Flow|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371553|NCT00412854|P1|Participant Flow|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371554|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371555|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371556|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371557|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371727|NCT00413036|E1|Reported Event|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
371728|NCT00413049|B3|Baseline|Total|Total of all reporting groups
371558|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371559|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371560|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371561|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371562|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371563|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371564|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371565|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371566|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371788|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371789|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371567|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371568|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371569|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371570|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371571|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371572|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371573|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371574|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371575|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371576|NCT00412854|E2|Reported Event|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
371577|NCT00412854|E1|Reported Event|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
371578|NCT00412867|B1|Baseline|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
371579|NCT00412867|P1|Participant Flow|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
371580|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
371581|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
371582|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
371583|NCT00412867|E2|Reported Event|Alteplase (Haemorrhage)|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
371584|NCT00412867|E1|Reported Event|Alteplase (Non-Haemorrhage)|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
371585|NCT00412893|B3|Baseline|Total|Total of all reporting groups
371586|NCT00412893|B2|Baseline|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371587|NCT00412893|B1|Baseline|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371588|NCT00412893|P2|Participant Flow|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371589|NCT00412893|P1|Participant Flow|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371590|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371591|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371592|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371790|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371593|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371594|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371595|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371596|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371597|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371598|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371599|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371600|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371601|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371602|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371603|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371604|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371605|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371879|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371606|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371607|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371608|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371609|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371610|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371611|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371612|NCT00412893|E2|Reported Event|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
371613|NCT00412893|E1|Reported Event|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
371614|NCT00412932|B1|Baseline|Active Treatment Period|All participants started the active treatment period with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40 mg Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
371615|NCT00412932|P1|Participant Flow|Active Treatment Period|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
371616|NCT00412932|O1|Outcome|Overall Study|
371617|NCT00412932|O1|Outcome|Overall Study|
371618|NCT00412932|O1|Outcome|Overall Study|
371619|NCT00412932|O1|Outcome|Overall Study|
371620|NCT00412932|O1|Outcome|Overall Study|
371621|NCT00412932|O1|Outcome|Overall Study|
371622|NCT00412932|O1|Outcome|Overall Study|
371623|NCT00412958|B5|Baseline|Total|Total of all reporting groups
371624|NCT00412958|B4|Baseline|Placebo|Intravitreal injection of placebo.
371625|NCT00412958|B3|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
371626|NCT00412958|B2|Baseline|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
371627|NCT00412958|B1|Baseline|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection
371628|NCT00412958|P4|Participant Flow|Placebo|Intravitreal injection of placebo.
371629|NCT00412958|P3|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
371630|NCT00412958|P2|Participant Flow|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
371631|NCT00412958|P1|Participant Flow|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection.
371632|NCT00412958|O4|Outcome|Placebo|Intravitreal injection of placebo.
371633|NCT00412958|O3|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
371634|NCT00412958|O2|Outcome|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
371635|NCT00412958|O1|Outcome|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection.
371636|NCT00412958|E4|Reported Event|Placebo|Intravitreal injection of placebo.
371637|NCT00412958|E3|Reported Event|Ocriplasmin 125µg|125µg of ocriplasmin intravitreal injection.
371638|NCT00412958|E2|Reported Event|Ocriplasmin 75µg|75µg of ocriplasmin intravitreal injection.
371639|NCT00412958|E1|Reported Event|Ocriplasmin 25µg|25µg of ocriplasmin intravitreal injection.
371640|NCT00412971|B3|Baseline|Total|Total of all reporting groups
371641|NCT00412971|B2|Baseline|White Light|Standard White light cystoscopy
371642|NCT00412971|B1|Baseline|Hexvix Cystoscopy Group|
371643|NCT00412971|P2|Participant Flow|White Light|Standard White light cystoscopy
371644|NCT00412971|P1|Participant Flow|Hexvix Cystoscopy Group|
371645|NCT00412971|O2|Outcome|White Light|Standard White light cystoscopy
371646|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
371647|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
371648|NCT00412971|O2|Outcome|White Light|Standard White light cystoscopy
371649|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
371650|NCT00412971|E2|Reported Event|White Light|Standard White light cystoscopy
371651|NCT00412971|E1|Reported Event|Hexvix Cystoscopy Group|
371652|NCT00412984|B3|Baseline|Total|Total of all reporting groups
375771|NCT00425698|O2|Outcome|Placebo|
371653|NCT00412984|B2|Baseline|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371654|NCT00412984|B1|Baseline|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371655|NCT00412984|P2|Participant Flow|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371656|NCT00412984|P1|Participant Flow|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371657|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371791|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371792|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371658|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371659|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371660|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371661|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371662|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371663|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371664|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371665|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371666|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371667|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371702|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
375772|NCT00425698|O1|Outcome|Erythropoietin|
371668|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371669|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371670|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371671|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371672|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371673|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371674|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371675|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371676|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371677|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371678|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371679|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371680|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371681|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371682|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371725|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
371726|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
372366|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
371683|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371684|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371685|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371686|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371687|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371688|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371689|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371690|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371691|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371692|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371693|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
371694|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
371695|NCT00412984|E2|Reported Event|Apixaban|
371696|NCT00412984|E1|Reported Event|Warfarin|
371697|NCT00413010|B3|Baseline|Total|Total of all reporting groups
371698|NCT00413010|B2|Baseline|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371699|NCT00413010|B1|Baseline|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371700|NCT00413010|P2|Participant Flow|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371701|NCT00413010|P1|Participant Flow|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371703|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371704|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371705|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371706|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371707|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371793|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371794|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371708|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371709|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371710|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371711|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371712|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371713|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371714|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371715|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371716|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371717|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371718|NCT00413010|E2|Reported Event|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371719|NCT00413010|E1|Reported Event|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
371720|NCT00413036|B1|Baseline|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
371721|NCT00413036|P1|Participant Flow|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
371722|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
371723|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
371724|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
371729|NCT00413049|B2|Baseline|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371730|NCT00413049|B1|Baseline|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371731|NCT00413049|P2|Participant Flow|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371732|NCT00413049|P1|Participant Flow|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371733|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371734|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371795|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371735|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371736|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371737|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371738|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371739|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371740|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371741|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371742|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371743|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371744|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371745|NCT00413049|E2|Reported Event|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371746|NCT00413049|E1|Reported Event|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
371747|NCT00413062|B3|Baseline|Total|Total of all reporting groups
371748|NCT00413062|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371749|NCT00413062|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371750|NCT00413062|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371751|NCT00413062|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371752|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371753|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371754|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371755|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371756|NCT00413062|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
371796|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371797|NCT00413153|E2|Reported Event|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371757|NCT00413062|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
371758|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371759|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371760|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371761|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371762|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371763|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371764|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371765|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371766|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371767|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371768|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371769|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371770|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371771|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371772|NCT00413062|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371880|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371773|NCT00413062|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
371774|NCT00413153|B3|Baseline|Total|Total of all reporting groups
371775|NCT00413153|B2|Baseline|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371776|NCT00413153|B1|Baseline|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371777|NCT00413153|P2|Participant Flow|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371778|NCT00413153|P1|Participant Flow|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371779|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371780|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371781|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371782|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371783|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371784|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371785|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
371786|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371798|NCT00413153|E1|Reported Event|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
371799|NCT00413192|B5|Baseline|Total|Total of all reporting groups
371800|NCT00413192|B4|Baseline|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371801|NCT00413192|B3|Baseline|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371802|NCT00413192|B2|Baseline|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371803|NCT00413192|B1|Baseline|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371804|NCT00413192|P4|Participant Flow|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371805|NCT00413192|P3|Participant Flow|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371806|NCT00413192|P2|Participant Flow|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371807|NCT00413192|P1|Participant Flow|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371808|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371809|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371810|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371811|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371812|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371813|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371814|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371897|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
375524|NCT00425100|O1|Outcome|Open Label Baseline|
371815|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371816|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371817|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371818|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371819|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371820|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371821|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371822|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371823|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371824|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
375773|NCT00425698|E2|Reported Event|Placebo|
371825|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371826|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371827|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371828|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371829|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371830|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371831|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371832|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371833|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371834|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371835|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371836|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371837|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371838|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371839|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371840|NCT00413192|E4|Reported Event|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371841|NCT00413192|E3|Reported Event|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371842|NCT00413192|E2|Reported Event|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371843|NCT00413192|E1|Reported Event|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
371844|NCT00413218|B3|Baseline|Total|Total of all reporting groups
371845|NCT00413218|B2|Baseline|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371846|NCT00413218|B1|Baseline|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
371862|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
371847|NCT00413218|P2|Participant Flow|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371848|NCT00413218|P1|Participant Flow|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
371849|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371850|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
371851|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371852|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
371853|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371854|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic participants could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole once daily.
371855|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371856|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
371881|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371882|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
375774|NCT00425698|E1|Reported Event|Erythropoietin|
371857|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371858|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
371859|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371860|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
371861|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371863|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371864|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
371865|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371866|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
371867|NCT00413218|E2|Reported Event|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
371868|NCT00413218|E1|Reported Event|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole once daily.
371869|NCT00413231|B1|Baseline|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371870|NCT00413231|P1|Participant Flow|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371871|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371872|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371873|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371874|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371875|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371876|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371877|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371878|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371984|NCT00413374|B1|Baseline|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
371883|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371884|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371885|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371886|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371887|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371888|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371889|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371890|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371891|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371892|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371893|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371894|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371895|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
371896|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|"160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.
There were no other arms for this study.
Valiant Thoracic Stent Graft System: Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm)."
371898|NCT00413231|E1|Reported Event|Valiant Thoracic Stent Graft System|"160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.
There were no other arms for this study."
371899|NCT00413244|B3|Baseline|Total|Total of all reporting groups
371900|NCT00413244|B2|Baseline|Placebo|Matching Placebo
371901|NCT00413244|B1|Baseline|Androgel|Androgel 5 grams
371902|NCT00413244|P2|Participant Flow|Placebo|Matching Placebo
371903|NCT00413244|P1|Participant Flow|Androgel|Androgel 5 grams
371904|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371905|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371906|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371907|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371908|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371909|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371910|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371911|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371912|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371913|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371914|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371915|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371916|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371917|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371918|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371919|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371920|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371921|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371922|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371923|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371924|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371925|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371926|NCT00413244|O2|Outcome|Placebo|Matching Placebo
371927|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
371928|NCT00413244|E2|Reported Event|Placebo|Matching Placebo
371929|NCT00413244|E1|Reported Event|Androgel|Androgel 5 grams
371930|NCT00413283|B5|Baseline|Total|Total of all reporting groups
371931|NCT00413283|B4|Baseline|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371932|NCT00413283|B3|Baseline|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371933|NCT00413283|B2|Baseline|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371985|NCT00413374|P1|Participant Flow|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
371990|NCT00413400|B2|Baseline|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
371934|NCT00413283|B1|Baseline|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371935|NCT00413283|P4|Participant Flow|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371936|NCT00413283|P3|Participant Flow|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371937|NCT00413283|P2|Participant Flow|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371938|NCT00413283|P1|Participant Flow|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371939|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371940|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371941|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371942|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371943|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371944|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371945|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371946|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371947|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371948|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371986|NCT00413374|O1|Outcome|Recurrent Venous Thromboembolism|Participants receiving Enoxaparin once daily who developed a VTE (either a DVT or PE) within 30 days.
371991|NCT00413400|B1|Baseline|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
371949|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371950|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371951|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371952|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371953|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371954|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371955|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371956|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371957|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371958|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371959|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371960|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371961|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371962|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371963|NCT00413283|E4|Reported Event|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371987|NCT00413374|O1|Outcome|Major Bleeding Complication|Study participants receiving Enoxaparin once daily who developed a major bleeding complication within 30 days.
371988|NCT00413374|E1|Reported Event|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
371964|NCT00413283|E3|Reported Event|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371965|NCT00413283|E2|Reported Event|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371966|NCT00413283|E1|Reported Event|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
371967|NCT00413335|B3|Baseline|Total|Total of all reporting groups
371968|NCT00413335|B2|Baseline|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.
Placebo : Subject receives placebo."
371969|NCT00413335|B1|Baseline|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.
Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
371970|NCT00413335|P2|Participant Flow|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.
Placebo : Subject receives placebo."
372010|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
372065|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
371971|NCT00413335|P1|Participant Flow|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.
Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
371972|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.
Placebo : Subject receives placebo."
371973|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.
Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
371974|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.
Placebo : Subject receives placebo."
371975|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.
Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
371976|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.
Placebo : Subject receives placebo."
371977|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.
Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
371978|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.
Placebo : Subject receives placebo."
371979|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.
Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
371980|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.
Placebo : Subject receives placebo."
371981|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.
Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
371982|NCT00413335|E2|Reported Event|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.
Placebo : Subject receives placebo."
371983|NCT00413335|E1|Reported Event|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.
Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
371992|NCT00413400|P2|Participant Flow|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
371993|NCT00413400|P1|Participant Flow|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
371994|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
371995|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
371996|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
371997|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
371998|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
371999|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
372000|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
372001|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
372002|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
372003|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
372004|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
372005|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
372006|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
372007|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
372008|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
372009|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
372011|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
372012|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
372013|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
372014|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
372015|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
372016|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
372017|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
372018|NCT00413400|E2|Reported Event|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
372019|NCT00413400|E1|Reported Event|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
372020|NCT00413413|B4|Baseline|Total|Total of all reporting groups
372021|NCT00413413|B3|Baseline|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372022|NCT00413413|B2|Baseline|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372023|NCT00413413|B1|Baseline|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
372024|NCT00413413|P3|Participant Flow|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372025|NCT00413413|P2|Participant Flow|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372026|NCT00413413|P1|Participant Flow|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
372027|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372028|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372029|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
372030|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372031|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372032|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
372033|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372034|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372035|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
372036|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372037|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372038|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
372039|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372040|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372041|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
372042|NCT00413413|E3|Reported Event|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372043|NCT00413413|E2|Reported Event|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
372044|NCT00413413|E1|Reported Event|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
372045|NCT00413478|B1|Baseline|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
372046|NCT00413478|P1|Participant Flow|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
372047|NCT00413478|O1|Outcome|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
372048|NCT00413478|E1|Reported Event|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
372049|NCT00413582|B3|Baseline|Total|Total of all reporting groups
372050|NCT00413582|B2|Baseline|PCA Group|IV narcotic analgesia arm of study
372051|NCT00413582|B1|Baseline|Epidural Group|Epidural analgesia arm of study
372052|NCT00413582|P2|Participant Flow|PCA Group|IV narcotic analgesia arm of study
372053|NCT00413582|P1|Participant Flow|Epidural Group|Epidural analgesia arm of study
372054|NCT00413582|O2|Outcome|PCA Group|IV narcotic analgesia arm of study
372055|NCT00413582|O1|Outcome|Epidural Group|Epidural analgesia arm of study
372056|NCT00413582|O2|Outcome|PCA Group|IV narcotic analgesia arm of study
372057|NCT00413582|O1|Outcome|Epidural Group|Epidural analgesia arm of study
372058|NCT00413582|E2|Reported Event|PCA Group|IV narcotic analgesia arm of study
372059|NCT00413582|E1|Reported Event|Epidural Group|Epidural analgesia arm of study
372060|NCT00413634|B3|Baseline|Total|Total of all reporting groups
372061|NCT00413634|B2|Baseline|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372062|NCT00413634|B1|Baseline|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372063|NCT00413634|P2|Participant Flow|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372064|NCT00413634|P1|Participant Flow|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372066|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372067|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372068|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372069|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
372070|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
372071|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
372072|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
372073|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
372074|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
372075|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
372076|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
372077|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
372078|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
372079|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
372080|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
372081|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372082|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372083|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372084|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372085|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372086|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372087|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372088|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372089|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372090|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372091|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372092|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372093|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372094|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372095|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372096|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372097|NCT00413634|E2|Reported Event|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
372098|NCT00413634|E1|Reported Event|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
372099|NCT00413660|B8|Baseline|Total|Total of all reporting groups
372100|NCT00413660|B7|Baseline|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372130|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372101|NCT00413660|B6|Baseline|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372102|NCT00413660|B5|Baseline|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372103|NCT00413660|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372104|NCT00413660|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372105|NCT00413660|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372106|NCT00413660|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372107|NCT00413660|P11|Participant Flow|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372108|NCT00413660|P10|Participant Flow|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372109|NCT00413660|P9|Participant Flow|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372110|NCT00413660|P8|Participant Flow|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372111|NCT00413660|P7|Participant Flow|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372112|NCT00413660|P6|Participant Flow|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372113|NCT00413660|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372114|NCT00413660|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372115|NCT00413660|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372116|NCT00413660|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372117|NCT00413660|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372118|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372119|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372120|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372121|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372122|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372123|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372124|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372125|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372126|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372127|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372128|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372129|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
376004|NCT00426751|B3|Baseline|Total|Total of all reporting groups
372131|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372132|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372133|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372134|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372135|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372136|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372137|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372138|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372139|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372140|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372141|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372142|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372143|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372144|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372145|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372146|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372147|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372148|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372149|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372150|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372151|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372152|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372153|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372154|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372155|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372156|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372157|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372158|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372159|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372160|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372161|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372162|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372163|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372164|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372165|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372166|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372167|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372168|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372169|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372170|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372171|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372172|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372173|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372174|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372175|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372176|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372177|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372178|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372179|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372180|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372181|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372182|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372183|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372184|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372185|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372186|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372187|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372188|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372189|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
376896|NCT00427804|P1|Participant Flow|Healthy Control|
372191|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372192|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372193|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372194|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372195|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372196|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372197|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372198|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372199|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372200|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372201|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372202|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372203|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372204|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372205|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372206|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372207|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372208|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372209|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372210|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372211|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372212|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372213|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372214|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372215|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372216|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372217|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372218|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372553|NCT00413972|B1|Baseline|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
372219|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372220|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372221|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372222|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372223|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372224|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372225|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372226|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372227|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372228|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372229|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372230|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372231|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372232|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372233|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372234|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372235|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372236|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372237|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372238|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372239|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372240|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372241|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372242|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372243|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372244|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372245|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372246|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372247|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372248|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372249|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372250|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372251|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372252|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372253|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372254|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372255|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372256|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372257|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372258|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372259|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372260|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372261|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372262|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372263|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372264|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372265|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372266|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372267|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372268|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372269|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372270|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372271|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372272|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372273|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372274|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372275|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372276|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372277|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372554|NCT00413972|P4|Participant Flow|Placebo|
372279|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372280|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372281|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372282|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372283|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372284|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372285|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372286|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372287|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372288|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372289|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372290|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372291|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372292|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372293|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372294|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372295|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372296|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372297|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372298|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372299|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372300|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372301|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372302|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372303|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372304|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372305|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372306|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372555|NCT00413972|P3|Participant Flow|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
372307|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372308|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372309|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372310|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372311|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372312|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372313|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372314|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372315|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372316|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372317|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372318|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372319|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372320|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372321|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372322|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372323|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372324|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372325|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372326|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372327|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372328|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372329|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372330|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372331|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372332|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372333|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372334|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372335|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372336|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372337|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372338|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372339|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372340|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372341|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372342|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372343|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372344|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372345|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372346|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372347|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372348|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372349|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372350|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372351|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372352|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372353|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372354|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372355|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372356|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372357|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372358|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372359|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372360|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372361|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372362|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372363|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372364|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372365|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
377832|NCT00421993|E4|Reported Event|Gel Vehicle|Topical Gel Vehicle
372367|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372368|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372369|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372370|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372371|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372372|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372373|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372374|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372375|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372376|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372377|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372378|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372379|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372380|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372381|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372382|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372383|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372384|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372385|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372386|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372387|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372388|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372389|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372390|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372391|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372392|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372393|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372394|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372556|NCT00413972|P2|Participant Flow|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
372395|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372396|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372397|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372398|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372399|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372400|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372401|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372402|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372403|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372404|NCT00413660|O7|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372467|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372405|NCT00413660|O6|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372406|NCT00413660|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372407|NCT00413660|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372408|NCT00413660|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372409|NCT00413660|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372410|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372411|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372412|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372413|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372414|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372415|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372416|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372417|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372418|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372419|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372420|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372421|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372422|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372423|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372557|NCT00413972|P1|Participant Flow|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
372424|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372425|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372426|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372427|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372428|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372429|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372430|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372431|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372432|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372433|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
375525|NCT00425100|O2|Outcome|Open Label Week 12|
372434|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372435|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372436|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372437|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372438|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372439|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372440|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372441|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372442|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
372443|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372444|NCT00413660|O7|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
372445|NCT00413660|O6|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
372446|NCT00413660|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
372447|NCT00413660|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
372448|NCT00413660|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
372449|NCT00413660|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
372450|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
372451|NCT00413660|E11|Reported Event|Placebo to CP-690,550 5 mg (R)|Matching placebo tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
372452|NCT00413660|E10|Reported Event|Placebo|Matching placebo tablet orally twice daily up to Week 24.
372453|NCT00413660|E9|Reported Event|CP-690,550 20 mg to CP-690,550 5 mg (R)|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 12 followed by CP-690,550 5 mg tablet orally twice daily up to Week 24.
372558|NCT00413972|O4|Outcome|Placebo|
372454|NCT00413660|E8|Reported Event|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 24.
372455|NCT00413660|E7|Reported Event|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24.
372456|NCT00413660|E6|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24.
372457|NCT00413660|E5|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24.
372458|NCT00413660|E4|Reported Event|CP-690,550 3 mg to CP-690,550 5 mg (R)|CP-690,550 3 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
372459|NCT00413660|E3|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24.
372460|NCT00413660|E2|Reported Event|CP-690,550 1 mg to CP-690,550 5 mg (R)|CP-690,550 1 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
372461|NCT00413660|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24.
372462|NCT00413777|B3|Baseline|Total|Total of all reporting groups
372463|NCT00413777|B2|Baseline|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372464|NCT00413777|B1|Baseline|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372465|NCT00413777|P2|Participant Flow|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372466|NCT00413777|P1|Participant Flow|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
373712|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
372468|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372469|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372470|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372471|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372472|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372473|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372474|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372475|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372476|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372477|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372478|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372479|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372480|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372481|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372482|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372483|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372484|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372485|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372486|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372487|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372488|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372489|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372490|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372491|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372492|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372493|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372494|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372495|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372496|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372890|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
372497|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372498|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372499|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372500|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372501|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372502|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372503|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372504|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372505|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372506|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372507|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372508|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372509|NCT00413777|E2|Reported Event|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372510|NCT00413777|E1|Reported Event|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
372511|NCT00413894|B1|Baseline|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372512|NCT00413894|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta (C.E.R.A)|During screening (Month -2 to -1), participants received their previous ESA (Erythropoiesis Stimulating Agent) (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 micrograms per month (μg/month) administered once monthly intravenously (IV). Doses were subsequently adjusted by investigator according to participant’s hemoglobin (Hb) values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372559|NCT00413972|O3|Outcome|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
372513|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372514|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372515|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372516|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372572|NCT00414050|B4|Baseline|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
372517|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372518|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372519|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372520|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372521|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372522|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372523|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372524|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372548|NCT00413959|E1|Reported Event|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
372549|NCT00413972|B5|Baseline|Total|Total of all reporting groups
372550|NCT00413972|B4|Baseline|Placebo|
372551|NCT00413972|B3|Baseline|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
372525|NCT00413894|E1|Reported Event|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
372526|NCT00413920|B3|Baseline|Total|Total of all reporting groups
372527|NCT00413920|B2|Baseline|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
372528|NCT00413920|B1|Baseline|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
372529|NCT00413920|P2|Participant Flow|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
372530|NCT00413920|P1|Participant Flow|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
372573|NCT00414050|B3|Baseline|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
372891|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
372531|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
372532|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
372533|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
372534|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
372535|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
372536|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
372537|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
372538|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
372539|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
372540|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
372541|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
372542|NCT00413920|E2|Reported Event|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
372543|NCT00413920|E1|Reported Event|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
372544|NCT00413959|B1|Baseline|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
372545|NCT00413959|P1|Participant Flow|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
372546|NCT00413959|O1|Outcome|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
372547|NCT00413959|O1|Outcome|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
372552|NCT00413972|B2|Baseline|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
372560|NCT00413972|O2|Outcome|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
372561|NCT00413972|O1|Outcome|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
372562|NCT00413972|E4|Reported Event|Placebo|
372563|NCT00413972|E3|Reported Event|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
372564|NCT00413972|E2|Reported Event|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
372565|NCT00413972|E1|Reported Event|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
372566|NCT00414011|B1|Baseline|Moxifloxacin/Gatifloxacin Treatment|"Both eyes were treated. Each participant was randomly assigned to either:
Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye
Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye
Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery"
372567|NCT00414011|P1|Participant Flow|Moxifloxacin/Gatifloxacin Treatment|"Both eyes were treated. Each participant was randomly assigned to either:
Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye
Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye
Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery"
372568|NCT00414011|O2|Outcome|Gatifloxacin|Gatifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
372569|NCT00414011|O1|Outcome|Moxifloxacin|Moxifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
372570|NCT00414011|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
372571|NCT00414050|B5|Baseline|Total|Total of all reporting groups
374543|NCT00412425|E2|Reported Event|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
372574|NCT00414050|B2|Baseline|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
372575|NCT00414050|B1|Baseline|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
372576|NCT00414050|P4|Participant Flow|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
372577|NCT00414050|P3|Participant Flow|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
372578|NCT00414050|P2|Participant Flow|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
372579|NCT00414050|P1|Participant Flow|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
372580|NCT00414050|O4|Outcome|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
372581|NCT00414050|O3|Outcome|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
372582|NCT00414050|O2|Outcome|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
372583|NCT00414050|O1|Outcome|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
372584|NCT00414050|O4|Outcome|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
372585|NCT00414050|O3|Outcome|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
372586|NCT00414050|O2|Outcome|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
372587|NCT00414050|O1|Outcome|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
372588|NCT00414050|E4|Reported Event|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
372589|NCT00414050|E3|Reported Event|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
372590|NCT00414050|E2|Reported Event|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
372591|NCT00414050|E1|Reported Event|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
372592|NCT00414167|B3|Baseline|Total|Total of all reporting groups
372593|NCT00414167|B2|Baseline|Placebo|"Placebo
Placebo : Placebo"
372594|NCT00414167|B1|Baseline|Bupropion|"Bupropion
bupropion : 300 mg per day for 8 weeks"
372595|NCT00414167|P2|Participant Flow|Placebo|"Placebo
Placebo : Placebo"
372596|NCT00414167|P1|Participant Flow|Bupropion (300 mg/d)|"Bupropion
bupropion : 300 mg per day for 8 weeks"
372597|NCT00414167|O2|Outcome|Placebo|"Placebo
Placebo : Placebo"
372598|NCT00414167|O1|Outcome|Bupropion|"Bupropion
bupropion : 300 mg per day for 8 weeks"
372599|NCT00414167|O2|Outcome|Placebo|
372600|NCT00414167|O1|Outcome|Bupropion|
372601|NCT00414167|E2|Reported Event|Placebo|
372602|NCT00414167|E1|Reported Event|Bupropion|
372603|NCT00414206|B4|Baseline|Total|Total of all reporting groups
372604|NCT00414206|B3|Baseline|Placebo|
372605|NCT00414206|B2|Baseline|0.3% Mecamylamine|
372606|NCT00414206|B1|Baseline|1% Mecamylamine|
372607|NCT00414206|P3|Participant Flow|Placebo|
372608|NCT00414206|P2|Participant Flow|0.3% Mecamylamine|
372609|NCT00414206|P1|Participant Flow|1% Mecamylamine|
372610|NCT00414206|O3|Outcome|Placebo|
372617|NCT00414310|B2|Baseline|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
372618|NCT00414310|B1|Baseline|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
372619|NCT00414310|P2|Participant Flow|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
372620|NCT00414310|P1|Participant Flow|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
372621|NCT00414310|O2|Outcome|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
372622|NCT00414310|O1|Outcome|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
372623|NCT00414310|E2|Reported Event|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
372624|NCT00414310|E1|Reported Event|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
372625|NCT00414388|B1|Baseline|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
372626|NCT00414388|P1|Participant Flow|Single Agent Sorafenib|Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (docetaxel or mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m^2 and mitoxantrone was given at 12 mg/m^2, both once every 21 days and both combined with prednisone at 5mg twice daily. A maximum of 6 cycles of sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive sorafenib monotherapy until disease progression.
372655|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating schedule"
372892|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
372627|NCT00414388|O1|Outcome|Sorafenib|Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (Docetaxel or Mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m2 and Mitoxantrone was given at 12 mg/m2, both once every 21 days and both combined with Prednisone at 5mg twice daily. A maximum of 6 cycles of Sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive Sorafenib monotherapy until disease progression.
372628|NCT00414388|O1|Outcome|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
372629|NCT00414388|O1|Outcome|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
372630|NCT00414388|E1|Reported Event|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
372631|NCT00414440|B3|Baseline|Total|Total of all reporting groups
372632|NCT00414440|B2|Baseline|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
372633|NCT00414440|B1|Baseline|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
372634|NCT00414440|P2|Participant Flow|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
372635|NCT00414440|P1|Participant Flow|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
372636|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
372637|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
372638|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
372639|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
372640|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
372641|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
372642|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
372643|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
372644|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
372645|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
372646|NCT00414440|E2|Reported Event|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses
372647|NCT00414440|E1|Reported Event|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
372648|NCT00414453|B1|Baseline|Lidocaine 5% + Placebo Patch, ER + Placebo Pills|"5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off
placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches
placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372679|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating schedule"
372649|NCT00414453|P1|Participant Flow|Lidocaine 5% + Placebo Patch, ER + Placebo Pills|"5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off
placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches
placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372650|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372651|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating schedule"
372652|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm
Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
372653|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention
Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
372654|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372988|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
372656|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm
Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
372657|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention
Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
372658|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372659|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating schedule"
372660|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm
Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
372661|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention
Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
372662|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372663|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating schedule"
372664|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm
Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
372665|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention
Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
372666|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372667|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating schedule"
372668|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm
Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
372669|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention
Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
372670|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372671|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating schedule"
372672|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm
Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
372673|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention
Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
372674|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372675|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating schedule"
372676|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm
Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
372677|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention
Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
372678|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372818|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
372680|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm
Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
372681|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention
Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
372682|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372683|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating schedule"
372684|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm
Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
372685|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention
Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
372686|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372687|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating schedule"
372688|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm
Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
372689|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention
Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
372690|NCT00414453|E4|Reported Event|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group
Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
372691|NCT00414453|E3|Reported Event|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period
Extended-release oxycodone: extended-release oxycodone titrating schedule"
372692|NCT00414453|E2|Reported Event|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm
Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
372693|NCT00414453|E1|Reported Event|Lidocaine Patch 5%|"5% lidocaine patch used as intervention
Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
372694|NCT00414466|B5|Baseline|Total|Total of all reporting groups
372695|NCT00414466|B4|Baseline|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372696|NCT00414466|B3|Baseline|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372697|NCT00414466|B2|Baseline|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372698|NCT00414466|B1|Baseline|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
372699|NCT00414466|P4|Participant Flow|4 Gabapentin High (30mg/Day)|Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372700|NCT00414466|P3|Participant Flow|3 Gabapentin Medium (6mg/Day)|Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372701|NCT00414466|P2|Participant Flow|2 Gabapentin Low (1mg/Day)|Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372702|NCT00414466|P1|Participant Flow|1 Placebo (0mg/Day)|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
372703|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372704|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372705|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372706|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
372707|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372708|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372709|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372710|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
372711|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372712|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372713|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372714|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
372715|NCT00414466|E4|Reported Event|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
378733|NCT00423332|E3|Reported Event|Cediranib OL|Open Label part
372716|NCT00414466|E3|Reported Event|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372717|NCT00414466|E2|Reported Event|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
372718|NCT00414466|E1|Reported Event|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
372719|NCT00414518|B3|Baseline|Total|Total of all reporting groups
372720|NCT00414518|B2|Baseline|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
372721|NCT00414518|B1|Baseline|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
372722|NCT00414518|P2|Participant Flow|CD4 T Cell Guided Therapy|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
372723|NCT00414518|P1|Participant Flow|Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
372724|NCT00414518|O2|Outcome|CD4 T Cell Guided Therapy|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
372725|NCT00414518|O1|Outcome|12 Week Treatment Folllowed by Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
372726|NCT00414518|O2|Outcome|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
372727|NCT00414518|O1|Outcome|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
372728|NCT00414518|O2|Outcome|CD4 T Cell Guided Therapyh|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
372729|NCT00414518|O1|Outcome|12 Week Treatment Arm Followed by Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
372730|NCT00414518|E2|Reported Event|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
372731|NCT00414518|E1|Reported Event|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
372732|NCT00414544|B1|Baseline|CosmetaLife vs Restylane|Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
372733|NCT00414544|P1|Participant Flow|CosmetaLife vs Restylane|Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
372734|NCT00414544|O2|Outcome|Restylane (Control)|Restylane (Control) injected nasolabial fold contralateral side
372735|NCT00414544|O1|Outcome|CosmetaLife|CosmetaLife injected nasolabial fold side
372736|NCT00414544|E2|Reported Event|Restylane (Control)|
372737|NCT00414544|E1|Reported Event|CosmetaLife|
372738|NCT00414596|B1|Baseline|DRX Group|Patients using the device DRX9000™.
372739|NCT00414596|P1|Participant Flow|DRX Group|Patients using the device DRX9000™.
372740|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
372741|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
372742|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
372743|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
372744|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
372745|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
372746|NCT00414596|E1|Reported Event|DRX Group|Patients using the device DRX9000™.
372747|NCT00414609|B3|Baseline|Total|Total of all reporting groups
372748|NCT00414609|B2|Baseline|Aliskiren|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
372749|NCT00414609|B1|Baseline|Placebo|Placebo for 36 weeks once daily in the morning
372750|NCT00414609|P3|Participant Flow|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.
Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
372751|NCT00414609|P2|Participant Flow|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
372752|NCT00414609|P1|Participant Flow|Placebo_Core|Placebo for 36 weeks once daily in the morning
372782|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
372753|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.
Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
372754|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.
Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
372755|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.
Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
372756|NCT00414609|O1|Outcome|Aliskiren_Extension|150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study.
372788|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
374544|NCT00412425|E1|Reported Event|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
372757|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.
Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
372758|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.
Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
372759|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
372760|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
372761|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
372762|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
372763|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
372764|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
372765|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
372766|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
372767|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
372768|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
372769|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
372770|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
372771|NCT00414609|E3|Reported Event|Aliskiren_extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.
Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
372772|NCT00414609|E2|Reported Event|Aliskiren_core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
372773|NCT00414609|E1|Reported Event|Placebo_core|Placebo for 36 weeks once daily in the morning
372774|NCT00414635|B3|Baseline|Total|Total of all reporting groups
372775|NCT00414635|B2|Baseline|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
372776|NCT00414635|B1|Baseline|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
372777|NCT00414635|P2|Participant Flow|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
372778|NCT00414635|P1|Participant Flow|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
372779|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
372780|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
372781|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
372783|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
372784|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
372785|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
372786|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
372787|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
372887|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
372789|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
372790|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
372791|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
372792|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
372793|NCT00414635|E2|Reported Event|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
372794|NCT00414635|E1|Reported Event|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
372795|NCT00414661|B5|Baseline|Total|Total of all reporting groups
372796|NCT00414661|B4|Baseline|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
372797|NCT00414661|B3|Baseline|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
372798|NCT00414661|B2|Baseline|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
372799|NCT00414661|B1|Baseline|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
372800|NCT00414661|P4|Participant Flow|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
372801|NCT00414661|P3|Participant Flow|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
372802|NCT00414661|P2|Participant Flow|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
372803|NCT00414661|P1|Participant Flow|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
372804|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
372805|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
372806|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
372807|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
372808|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
372809|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
372810|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
372811|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
372812|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
372813|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
372814|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
372815|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
372816|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
372817|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
372819|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
372820|NCT00414661|E4|Reported Event|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
372821|NCT00414661|E3|Reported Event|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
372822|NCT00414661|E2|Reported Event|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
372823|NCT00414661|E1|Reported Event|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
372824|NCT00414700|B3|Baseline|Total|Total of all reporting groups
372825|NCT00414700|B2|Baseline|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
372826|NCT00414700|B1|Baseline|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
372888|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
372889|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
372827|NCT00414700|P2|Participant Flow|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
372828|NCT00414700|P1|Participant Flow|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
372829|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
372830|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
372831|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
372832|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
372833|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
372834|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
372835|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
372836|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
372837|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
372838|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
372839|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
372840|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
372841|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
372842|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
372843|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
372844|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
372845|NCT00414700|E2|Reported Event|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
372874|NCT00414908|P2|Participant Flow|Placebo (DB)|Placebo group given during the Double-Blind period
372846|NCT00414700|E1|Reported Event|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
372847|NCT00414726|B3|Baseline|Total|Total of all reporting groups
372848|NCT00414726|B2|Baseline|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
372849|NCT00414726|B1|Baseline|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
372850|NCT00414726|P2|Participant Flow|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
372851|NCT00414726|P1|Participant Flow|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
372852|NCT00414726|O2|Outcome|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
372853|NCT00414726|O1|Outcome|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
372854|NCT00414726|O2|Outcome|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
372855|NCT00414726|O1|Outcome|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
372856|NCT00414726|E2|Reported Event|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
372857|NCT00414726|E1|Reported Event|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
372858|NCT00414817|B3|Baseline|Total|Total of all reporting groups
372859|NCT00414817|B2|Baseline|Usual Care|usual care participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
372860|NCT00414817|B1|Baseline|Automated Phone-Based Refill Reminders|Intervention arm participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
372861|NCT00414817|P2|Participant Flow|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
372862|NCT00414817|P1|Participant Flow|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.
Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
372863|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
372864|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.
Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
372865|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
372866|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.
Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
372867|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
372868|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.
Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
372869|NCT00414817|E2|Reported Event|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
372870|NCT00414817|E1|Reported Event|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.
Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
372871|NCT00414908|B3|Baseline|Total|Total of all reporting groups
372872|NCT00414908|B2|Baseline|Placebo (DB)|Placebo group given during the Double-Blind period
372873|NCT00414908|B1|Baseline|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
378734|NCT00423332|E2|Reported Event|Placebo DB|Double Blind part
372875|NCT00414908|P1|Participant Flow|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
372876|NCT00414908|O1|Outcome|Pancrelipase (OL)|Pancrelipase delayed during Open-label. Dosing is directed by the investigator.
372877|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
372878|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
372879|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
372880|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
372881|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
372882|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
372883|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
372884|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
372885|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
372886|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
372893|NCT00414908|E3|Reported Event|Pancrelipase (OL)|Pancrelipase delayed capsules received by the patients during the 6-month Open Label. The dosing was directed by the investigator.
372894|NCT00414908|E2|Reported Event|Placebo (DB)|Placebo group meaning the treatment received during the 7-days double-blind period
372895|NCT00414908|E1|Reported Event|Pancrelipase (DB)|Pancrelipase delayed release capsules meaning the treatment received during the 7-days double-blind period
372896|NCT00414973|B5|Baseline|Total|Total of all reporting groups
372897|NCT00414973|B4|Baseline|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
372898|NCT00414973|B3|Baseline|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
372899|NCT00414973|B2|Baseline|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
372900|NCT00414973|B1|Baseline|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
372901|NCT00414973|P4|Participant Flow|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
372902|NCT00414973|P3|Participant Flow|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
372903|NCT00414973|P2|Participant Flow|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
372904|NCT00414973|P1|Participant Flow|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
372905|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
372906|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
372907|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
372908|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
372909|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
372910|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
372911|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
372912|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
372913|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
372914|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
372915|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
372916|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
372917|NCT00414973|E4|Reported Event|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
372918|NCT00414973|E3|Reported Event|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
372919|NCT00414973|E2|Reported Event|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
372920|NCT00414973|E1|Reported Event|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
372921|NCT00415051|B1|Baseline|Single Group Assignment|"RVF MP-12
RVF MP-12: Administer 1 ml SQ"
372922|NCT00415051|P1|Participant Flow|Single Group Assignment|"RVF MP-12
RVF MP-12: Administer 1 ml SQ"
372923|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12
RVF MP-12: Administer 1 ml SQ"
372924|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12
RVF MP-12: Administer 1 ml SQ"
372925|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12
RVF MP-12: Administer 1 ml SQ"
372926|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12
RVF MP-12: Administer 1 ml SQ"
372927|NCT00415051|E1|Reported Event|Single Group Assignment|"RVF MP-12
RVF MP-12: Administer 1 ml SQ"
372928|NCT00415168|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
372929|NCT00415168|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
372930|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
372931|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
372932|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
373038|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
372933|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
372934|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
372935|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
372936|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
372937|NCT00415168|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
372938|NCT00415194|B3|Baseline|Total|Total of all reporting groups
372939|NCT00415194|B2|Baseline|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372940|NCT00415194|B1|Baseline|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372941|NCT00415194|P2|Participant Flow|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372942|NCT00415194|P1|Participant Flow|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372943|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372944|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372945|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372946|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372947|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372948|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372949|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372950|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372951|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
373118|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373153|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
372952|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372953|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372954|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.
Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.
Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.
Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
372955|NCT00415194|E2|Reported Event|Placebo/Cisplatin|Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
372956|NCT00415194|E1|Reported Event|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meter square (mg/m2) administered intravenously (IV) plus cisplatin 75 mg/m2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
372957|NCT00408200|B3|Baseline|Total|Total of all reporting groups
372958|NCT00408200|B2|Baseline|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.
Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.
propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
372959|NCT00408200|B1|Baseline|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.
Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
372960|NCT00408200|P2|Participant Flow|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.
Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.
propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
372961|NCT00408200|P1|Participant Flow|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.
Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
372962|NCT00408200|O2|Outcome|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.
Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.
propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
372963|NCT00408200|O1|Outcome|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.
Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
372964|NCT00408200|O2|Outcome|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.
Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.
propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
373152|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
372965|NCT00408200|O1|Outcome|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.
Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
372966|NCT00408200|E2|Reported Event|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.
Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.
propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
372967|NCT00408200|E1|Reported Event|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.
Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
372968|NCT00408317|B1|Baseline|Entire Study Population|Includes all participants who received Ultrase® MT20 first and placebo first.
372969|NCT00408317|P2|Participant Flow|Placebo First, Then Ultrase®MT20|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in the first intervention period followed by Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in the second intervention period. Break period of 3 to 6 days and fixed dose second stabilization period of 4 days was maintained after first intervention period.
372970|NCT00408317|P1|Participant Flow|Ultrase® MT20 First, Then Placebo|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in the first intervention period followed by placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in the second intervention period. Break period of 3 to 6 days and fixed dose second stabilization period of 4 days was maintained after first intervention period.
372971|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
372972|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
372973|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
372974|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
372975|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
372976|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
372977|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
372978|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
372979|NCT00408317|E2|Reported Event|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
372980|NCT00408317|E1|Reported Event|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion,for 6 to 7 days in either first intervention period or second intervention period.
372981|NCT00408421|B3|Baseline|Total|Total of all reporting groups
373039|NCT00408421|O2|Outcome|Group 3 - Duloxetine 120mg|
373040|NCT00408421|O1|Outcome|Group 2 - Duloxetine 60mg|
373207|NCT00418938|P1|Participant Flow|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
372982|NCT00408421|B2|Baseline|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
372983|NCT00408421|B1|Baseline|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
372984|NCT00408421|P3|Participant Flow|Duloxetine 120 mg|Beginning at Week 7, patients receiving duloxetine 60 mg daily (QD) were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD
372985|NCT00408421|P2|Participant Flow|Duloxetine 60 mg|Patients randomly assigned to duloxetine 60 mg daily (QD) started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning at Week 7, patients on duloxetine 60 mg QD were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD.
372986|NCT00408421|P1|Participant Flow|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
372987|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
372989|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
372990|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
372991|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
372992|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
372993|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
372994|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
372995|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
372996|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
372997|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
372998|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
372999|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373000|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373001|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373002|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373003|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373004|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373005|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373006|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373007|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373008|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373009|NCT00408421|O2|Outcome|Group 3 - Duloxetine 120mg|
373010|NCT00408421|O1|Outcome|Group 2 - Duloxetine 60mg|
373320|NCT00419263|P3|Participant Flow|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
373011|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373012|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373013|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373014|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373015|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373016|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373217|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
373017|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373018|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373019|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373020|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373021|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373022|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373023|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373024|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373025|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373026|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373027|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373028|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373029|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373030|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373031|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373032|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373033|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373034|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373035|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373036|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373037|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
378735|NCT00423332|E1|Reported Event|Cediranib DB|Double Blind part
373041|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373042|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373043|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373044|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373045|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373046|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373047|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373048|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373049|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373050|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373051|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373052|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373053|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373054|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373055|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
373056|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
373057|NCT00408421|E2|Reported Event|Duloxetine 60/120 mg QD|Duloxetine 60/120 mg QD
373058|NCT00408421|E1|Reported Event|Placebo|Placebo
373059|NCT00408460|B1|Baseline|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given PO
paclitaxel: Given IV
immunohistochemistry staining method: Optional correlative studies"
373060|NCT00408460|P1|Participant Flow|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given PO
paclitaxel: Given IV
immunohistochemistry staining method: Optional correlative studies"
373061|NCT00408460|O1|Outcome|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given PO
paclitaxel: Given IV
immunohistochemistry staining method: Optional correlative studies"
373062|NCT00408460|O1|Outcome|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given PO
paclitaxel: Given IV
immunohistochemistry staining method: Optional correlative studies"
373063|NCT00408460|O1|Outcome|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given PO
paclitaxel: Given IV
immunohistochemistry staining method: Optional correlative studies"
373064|NCT00408460|E1|Reported Event|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given PO
paclitaxel: Given IV
immunohistochemistry staining method: Optional correlative studies"
373109|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373110|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373454|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
373065|NCT00408499|B1|Baseline|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
373066|NCT00408499|P5|Participant Flow|Phase II- Dose Expansion|Phase II dose expansion at determined MTD
373067|NCT00408499|P4|Participant Flow|Dose Level 4|150 mg Erlotinib, 250 mg/m2 Cetuximab
373068|NCT00408499|P3|Participant Flow|Dose Level 3|100 mg Erlotinib, 250 mg/m2 Cetuximab
373069|NCT00408499|P2|Participant Flow|Dose Level 2|100 mg Erlotinib, 200 mg/m2 Cetuximab
373070|NCT00408499|P1|Participant Flow|Dose Level 1|100 mg Erlotinib, 150 mg/m2 Cetuximab
373071|NCT00408499|O1|Outcome|Phase II Expansion|44 Patients at dose level 4 phase II expansion: 150 mg Erlotinib, 250 mg/m2 Cetuximab
373255|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
374545|NCT00412451|B5|Baseline|Total|Total of all reporting groups
373072|NCT00408499|O1|Outcome|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
373073|NCT00408499|O4|Outcome|Dose Level 4|150 mg Erlotinib, 250 mg/m2 Cetuximab
373074|NCT00408499|O3|Outcome|Dose Level 3|100 mg Erlotinib, 250 mg/m2 Cetuximab
373075|NCT00408499|O2|Outcome|Dose Level 2|100 mg Erlotinib, 200 mg/m2 Cetuximab
373076|NCT00408499|O1|Outcome|Dose Level 1|100 mg Erlotinib, 150 mg/m2 Cetuximab
373077|NCT00408499|E1|Reported Event|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
373078|NCT00408603|B4|Baseline|Total|Total of all reporting groups
373079|NCT00408603|B3|Baseline|75 mg/m2|75 mg/m2 every 28 days
373080|NCT00408603|B2|Baseline|60 mg/m2|60 mg/m2 every 28 days
373081|NCT00408603|B1|Baseline|48 mg/m2|48 mg/m2 every 21 days
373082|NCT00408603|P3|Participant Flow|Stage 75 mg/m2|Following safety of 60 mg/m2 group, next Stage is 75 mg/m2 at 28 day periods up to 6 cycles.
373083|NCT00408603|P2|Participant Flow|Stage 60 mg/m2|Following safety of 48 mg/m2 group, next Stagel is 60mg/m2 at 28 day periods up to 6 cycles.
373084|NCT00408603|P1|Participant Flow|Stage 48 mg/m2|"All Stage 1 patients will receive voreloxin injection
Voreloxin Injection: All Stage 1 patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles."
373085|NCT00408603|O4|Outcome|Total|Overall
373086|NCT00408603|O3|Outcome|75 mg/m2|75 mg/m2 every 28 days
373087|NCT00408603|O2|Outcome|60 mg/m2|60 mg/m2 every 28 days
373088|NCT00408603|O1|Outcome|48 mg/m2|48 mg/m2 every 21 days
373089|NCT00408603|O4|Outcome|Total|Overall
373090|NCT00408603|O3|Outcome|75 mg/m2|75 mg/m2 every 28 days
373091|NCT00408603|O2|Outcome|60 mg/m2|60 mg/m2 every 28 days
373092|NCT00408603|O1|Outcome|48 mg/m2|48 mg/m2 every 21 days
373093|NCT00408603|E4|Reported Event|Total|Overall
373094|NCT00408603|E3|Reported Event|75 mg/m2|75 mg/m2 every 28 days
373095|NCT00408603|E2|Reported Event|60 mg/m2|60 mg/m2 every 28 days
373096|NCT00408603|E1|Reported Event|48 mg/m2|48 mg/m2 every 21 days
373097|NCT00408629|B3|Baseline|Total|Total of all reporting groups
373098|NCT00408629|B2|Baseline|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373099|NCT00408629|B1|Baseline|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373100|NCT00408629|P2|Participant Flow|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373101|NCT00408629|P1|Participant Flow|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373102|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373103|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373104|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373105|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373106|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373107|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373108|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373111|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373112|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373113|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373114|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373115|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373116|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373117|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373119|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373120|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373121|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373122|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373123|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373124|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373125|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373126|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373127|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373128|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373129|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373130|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373131|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373132|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373133|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373134|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
373135|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373136|NCT00408629|E3|Reported Event|Any Adalimumab|During the Double-Blind period, only the Adalimumab treatment group received active study drug (dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 [160/80/40 mg]). After the switch to open-label treatment, participants in both treatment groups received adalimumab 40 mg eow, unless they dose-escalated, in which case they received adalimumab 40 mg every week (ew). Consequently, this analysis set combined adalimumab exposure from both the Double-Blind and Open-Label periods.
373137|NCT00408629|E2|Reported Event|Placebo Group - Double-Blind Period|The placebo treatment group received placebo throughout the Double-Blind period.
373138|NCT00408629|E1|Reported Event|Adalimumab Group - Double-Blind Period|During the Double-Blind period, the Adalimumab treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
373139|NCT00408681|B1|Baseline|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373140|NCT00408681|P1|Participant Flow|Treated Patients|Patients receive oral lithium carbonate once or twice daily orally. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373141|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373142|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373143|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373144|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373552|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
373145|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373146|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373147|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373148|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373149|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373150|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373151|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373154|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373155|NCT00408681|E1|Reported Event|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
373156|NCT00408694|B1|Baseline|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.
ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
373157|NCT00408694|P1|Participant Flow|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.
ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
373158|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.
ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
373159|NCT00408694|E1|Reported Event|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.
ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Data is reported for eligible patients with adverse event data who started study treatment, which is 44 patients."
373160|NCT00415493|B3|Baseline|Total|Total of all reporting groups
373161|NCT00415493|B2|Baseline|Controls|normal subjects
373162|NCT00415493|B1|Baseline|Cases|non-allergic rhinitis subjects
373163|NCT00415493|P2|Participant Flow|Warm-moist Air Followed by Cold-dry Air|To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Warm-moist air followed (on a separate day) by Cold-dry air. Exposures lasted 15 minutes, with a one-hour follow-up period.
373164|NCT00415493|P1|Participant Flow|Cold-dry Air Followed by Warm-moist Air|To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Cold-dry air followed (on a separate day) by Warm-moist air. Exposures lasted 15 minutes, with a one-hour follow-up period.
373165|NCT00415493|O2|Outcome|Controls|normal subjects
373166|NCT00415493|O1|Outcome|Cases|non-allergic rhinitis subjects
373167|NCT00415493|E2|Reported Event|Controls|normal subjects
373168|NCT00415493|E1|Reported Event|Cases|non-allergic rhinitis subjects
373169|NCT00415506|B3|Baseline|Total|Total of all reporting groups
373170|NCT00415506|B2|Baseline|Orbital Inflammation|Subjects with Orbital Inflammation
373171|NCT00415506|B1|Baseline|Scleritis|Subjects with Scleritis
373206|NCT00418938|P2|Participant Flow|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
373172|NCT00415506|P2|Participant Flow|Orbital Inflammation|Patients with non-infectious orbital inflammatory disease, and is a phase I, prospective clinical trial to examine the safety of the 2 infusions of rituximab intravenously, 2 weeks apart, in the treatment of non-infectious orbital inflammation. The first 5 patients will receive 1000 mg of rituximab at each infusion, any additional patients will be randomized to receive either 500 mg or 1000 mg of rituximab.
373173|NCT00415506|P1|Participant Flow|Scleritis|Patients with non-infectious scleritis and is a phase II, randomized, double-blinded, prospective clinical trial of two different doses of rituximab to compare the safety and efficacy of these 2 doses. Patients will be randomized to either 500 mg or 1000 mg of rituximab administered intravenously two weeks apart.
373174|NCT00415506|O2|Outcome|Orbital Inflammation|Subjects with Orbital Inflammation
373175|NCT00415506|O1|Outcome|Scleritis|Subjects with Scleritis
373176|NCT00415506|O2|Outcome|Orbital Inflammation|Subjects with Orbital Inflammation
373177|NCT00415506|O1|Outcome|Scleritis|Subjects with Scleritis
373178|NCT00415506|E2|Reported Event|Scleritis|Subjects with Scleritis
373179|NCT00415506|E1|Reported Event|Orbital Inflammation|Subjects with Orbital Inflammation
373180|NCT00415532|B3|Baseline|Total|Total of all reporting groups
373181|NCT00415532|B2|Baseline|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
373182|NCT00415532|B1|Baseline|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
373183|NCT00415532|P2|Participant Flow|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
373184|NCT00415532|P1|Participant Flow|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
373185|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
373186|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
373187|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
373188|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
373189|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
373190|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
373191|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
373192|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
373193|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
373194|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
373195|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
373196|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
373197|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
373198|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
373199|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
373200|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
373201|NCT00415532|E2|Reported Event|AMG 531|
373202|NCT00415532|E1|Reported Event|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
373203|NCT00418938|B3|Baseline|Total|Total of all reporting groups
373204|NCT00418938|B2|Baseline|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
373205|NCT00418938|B1|Baseline|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
373208|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
373209|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
373210|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
373211|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
373212|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
373213|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
373214|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
373215|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
373216|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
373256|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
373218|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
373219|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
373220|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
373221|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
373222|NCT00418938|E2|Reported Event|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
373223|NCT00418938|E1|Reported Event|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
373224|NCT00418951|B4|Baseline|Total|Total of all reporting groups
373225|NCT00418951|B3|Baseline|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
373226|NCT00418951|B2|Baseline|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
373227|NCT00418951|B1|Baseline|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
373228|NCT00418951|P3|Participant Flow|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
373229|NCT00418951|P2|Participant Flow|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
373230|NCT00418951|P1|Participant Flow|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
373231|NCT00418951|O3|Outcome|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
373232|NCT00418951|O2|Outcome|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
373233|NCT00418951|O1|Outcome|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
373234|NCT00418951|E3|Reported Event|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
373235|NCT00418951|E2|Reported Event|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
373236|NCT00418951|E1|Reported Event|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
373237|NCT00418964|B4|Baseline|Total|Total of all reporting groups
373238|NCT00418964|B3|Baseline|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
373239|NCT00418964|B2|Baseline|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
373240|NCT00418964|B1|Baseline|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
373241|NCT00418964|P3|Participant Flow|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
373242|NCT00418964|P2|Participant Flow|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
373243|NCT00418964|P1|Participant Flow|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
373244|NCT00418964|O3|Outcome|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
373245|NCT00418964|O2|Outcome|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
373246|NCT00418964|O1|Outcome|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
373247|NCT00418964|E3|Reported Event|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
373248|NCT00418964|E2|Reported Event|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
373249|NCT00418964|E1|Reported Event|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
373250|NCT00418977|B3|Baseline|Total|Total of all reporting groups
373251|NCT00418977|B2|Baseline|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
373252|NCT00418977|B1|Baseline|Family Based Therapy|Participants received family based therapy (FBT)
373277|NCT00419003|E2|Reported Event|Placebo|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
373361|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373253|NCT00418977|P2|Participant Flow|Individual Supportive Psychotherapy|"Participants received individual supportive psychotherapy (ISP)
Individual Supportive Psychotherapy: The goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment."
373254|NCT00418977|P1|Participant Flow|Family Based Therapy|"Participants received family based therapy (FBT)
Family-Based Therapy (Maudsley Method): The goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction."
375526|NCT00425100|O1|Outcome|Open Label Baseline|
373257|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
373258|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
373259|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
373260|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
373261|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
373262|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
373263|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
373264|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
373265|NCT00418977|E2|Reported Event|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
373266|NCT00418977|E1|Reported Event|Family Based Therapy|Participants received family based therapy (FBT)
373267|NCT00419003|B3|Baseline|Total|Total of all reporting groups
373268|NCT00419003|B2|Baseline|Placebo Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
373269|NCT00419003|B1|Baseline|Lamotrigine Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
373270|NCT00419003|P2|Participant Flow|Placebo Pre-Treatment (Phase I)/Placebo (Phase II)|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)
373271|NCT00419003|P1|Participant Flow|Lamotrigine Pre-Treatment (Phase I)/Riluzole (Phase II)|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)
373272|NCT00419003|O2|Outcome|Placebo|Patients who responded (n=14) to the ketamine infusion (in either the lamotrigine or placebo pre-treatment groups) were randomized into phase II for treatment with either riluzole or placebo.
373273|NCT00419003|O1|Outcome|Riluzole Group|Patients who responded (n=14) to the ketamine infusion (in either the lamotrigine or placebo pre-treatment groups) were randomized into phase II for treatment with either riluzole or placebo. One patient in the riluzole group was discontinued/withdrew consent before completing the study.
373274|NCT00419003|E5|Reported Event|Placebo Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
373275|NCT00419003|E4|Reported Event|Lamotrigine Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
373276|NCT00419003|E3|Reported Event|Ketamine|IV infusion of 0.5 mg/kg of Ketamine Hydrochloride
373553|NCT00420017|O2|Outcome|Control|Control usual care
373278|NCT00419003|E1|Reported Event|Riluzole Group|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
373279|NCT00419094|B3|Baseline|Total|Total of all reporting groups
373280|NCT00419094|B2|Baseline|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
373281|NCT00419094|B1|Baseline|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
373282|NCT00419094|P2|Participant Flow|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
373283|NCT00419094|P1|Participant Flow|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
373284|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
373285|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
373286|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
373287|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
373288|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
373289|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
373290|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
373291|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
373292|NCT00419094|E2|Reported Event|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
373293|NCT00419094|E1|Reported Event|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
373294|NCT00419120|B1|Baseline|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
373295|NCT00419120|P1|Participant Flow|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
373296|NCT00419120|O1|Outcome|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
373297|NCT00419120|O1|Outcome|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
373298|NCT00419120|E1|Reported Event|Safety Population|All patients undergoing screeing and meeting inclusion/exclusion criteria
373299|NCT00419159|B3|Baseline|Total|Total of all reporting groups
373300|NCT00419159|B2|Baseline|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373301|NCT00419159|B1|Baseline|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373302|NCT00419159|P2|Participant Flow|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373303|NCT00419159|P1|Participant Flow|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373304|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373305|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373306|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373307|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373308|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373309|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373310|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373311|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373312|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373313|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373314|NCT00419159|E2|Reported Event|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373315|NCT00419159|E1|Reported Event|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
373316|NCT00419263|B4|Baseline|Total|Total of all reporting groups
373317|NCT00419263|B3|Baseline|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
373318|NCT00419263|B2|Baseline|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
373319|NCT00419263|B1|Baseline|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
373452|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
373321|NCT00419263|P2|Participant Flow|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
373322|NCT00419263|P1|Participant Flow|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
373323|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
373324|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
373325|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
373326|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
373327|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
373328|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
373329|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
373330|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
373331|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
375527|NCT00425113|B3|Baseline|Total|Total of all reporting groups
373332|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
373333|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
373334|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
373335|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
373336|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
373337|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
373338|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
373339|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
373340|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
373341|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
373342|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
373343|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
373344|NCT00419263|E4|Reported Event|Total|Total number of subjects who received at least 1 dose of study drug
373345|NCT00419263|E3|Reported Event|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
373346|NCT00419263|E2|Reported Event|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
373347|NCT00419263|E1|Reported Event|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
373348|NCT00419315|B3|Baseline|Total|Total of all reporting groups
373349|NCT00419315|B2|Baseline|Arm 2|"Usual care
Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
373350|NCT00419315|B1|Baseline|Arm 1|"Care management for alcohol dependence
Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
373351|NCT00419315|P2|Participant Flow|Arm 2|"Usual care
Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
373352|NCT00419315|P1|Participant Flow|Arm 1|"Care management for alcohol dependence
Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
373353|NCT00419315|O2|Outcome|Arm 2|"Usual care
Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
373354|NCT00419315|O1|Outcome|Arm 1|"Care management for alcohol dependence
Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
373355|NCT00419315|O2|Outcome|Arm 2|"Usual care
Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
373356|NCT00419315|O1|Outcome|Arm 1|"Care management for alcohol dependence
Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
373357|NCT00419315|E2|Reported Event|Arm 2|"Usual care
Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
373358|NCT00419315|E1|Reported Event|Arm 1|"Care management for alcohol dependence
Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
373359|NCT00419341|B1|Baseline|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373360|NCT00419341|P1|Participant Flow|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373453|NCT00419757|O2|Outcome|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
373362|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373363|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373364|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373365|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373366|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373367|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373368|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373369|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373370|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373371|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373372|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
374546|NCT00412451|B4|Baseline|Sham Injection|"Sham injection
Sham injection : Sham intravitreal injection"
373373|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373374|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373375|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373376|NCT00419341|O2|Outcome|IVIG (Privigen; Previous Study)|Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
373377|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373378|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373379|NCT00419341|E1|Reported Event|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
373380|NCT00419380|B3|Baseline|Total|Total of all reporting groups
373381|NCT00419380|B2|Baseline|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
373382|NCT00419380|B1|Baseline|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
373383|NCT00419380|P2|Participant Flow|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
373384|NCT00419380|P1|Participant Flow|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
373385|NCT00419380|O2|Outcome|Ofloxin|Ofloxin: 5 drops twice daily for 7 days to the affected ear. Right ear n=11; Left ear n=12
373386|NCT00419380|O1|Outcome|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): 5 drops twice daily for 7 days to the affected ear. Right ear n=8; Left ear n= 15
373387|NCT00419380|O2|Outcome|Ofloxin|Ofloxin: 5 drops twice daily for 7 days to the affected ear. Right ear n=11; Left ear n=12
373388|NCT00419380|O1|Outcome|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): 5 drops twice daily for 7 days to the affected ear. Right ear n=8; Left ear n= 15
373389|NCT00419380|E2|Reported Event|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
373390|NCT00419380|E1|Reported Event|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
373391|NCT00419393|B1|Baseline|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
373392|NCT00419393|P1|Participant Flow|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
373393|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
373394|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
373395|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
373396|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
373397|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
373398|NCT00419393|E1|Reported Event|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
373399|NCT00419445|B4|Baseline|Total|Total of all reporting groups
373400|NCT00419445|B3|Baseline|150 mg Tid|
373401|NCT00419445|B2|Baseline|75 mg Tid|
373402|NCT00419445|B1|Baseline|25 mg Tid|
373403|NCT00419445|P3|Participant Flow|150 mg Tid|
373404|NCT00419445|P2|Participant Flow|75 mg Tid|
373405|NCT00419445|P1|Participant Flow|25 mg Tid|
373406|NCT00419445|O3|Outcome|150 mg Tid|
373407|NCT00419445|O2|Outcome|75 mg Tid|
373408|NCT00419445|O1|Outcome|25 mg Tid|
373409|NCT00419445|E3|Reported Event|150 mg Tid|
373410|NCT00419445|E2|Reported Event|75 mg Tid|
373411|NCT00419445|E1|Reported Event|25 mg Tid|
373412|NCT00419744|B4|Baseline|Total|Total of all reporting groups
373413|NCT00419744|B3|Baseline|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
373414|NCT00419744|B2|Baseline|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
373415|NCT00419744|B1|Baseline|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
373416|NCT00419744|P3|Participant Flow|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
375132|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
373417|NCT00419744|P2|Participant Flow|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
373418|NCT00419744|P1|Participant Flow|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
373419|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
373420|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
373421|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
373422|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
373423|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
373424|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
373425|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
373426|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
373427|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
373428|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
373429|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
373430|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
373431|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
373432|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
373433|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
373434|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
373435|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
373436|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
373437|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
373438|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
373439|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
373440|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
373441|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
373442|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
373443|NCT00419744|E3|Reported Event|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
373444|NCT00419744|E2|Reported Event|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
373445|NCT00419744|E1|Reported Event|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
373446|NCT00419757|B3|Baseline|Total|Total of all reporting groups
373447|NCT00419757|B2|Baseline|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373448|NCT00419757|B1|Baseline|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373449|NCT00419757|P2|Participant Flow|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373450|NCT00419757|P1|Participant Flow|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373451|NCT00419757|O2|Outcome|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
373455|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373456|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373457|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373458|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373459|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373460|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373461|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373462|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373463|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373464|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373465|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373466|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373467|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373468|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
375528|NCT00425113|B2|Baseline|Placebo|
373469|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373470|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373471|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373472|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373473|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373474|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373475|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373476|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373477|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373478|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373479|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373480|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373481|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
373482|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
373483|NCT00419757|E2|Reported Event|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
373484|NCT00419757|E1|Reported Event|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
373485|NCT00419770|B3|Baseline|Total|Total of all reporting groups
373486|NCT00419770|B2|Baseline|Placebo|Placebo control plus background liposomal amphotericin
373487|NCT00419770|B1|Baseline|Deferasirox|Deferasirox plus liposomal amphotericin
373488|NCT00419770|P2|Participant Flow|Placebo|Placebo control plus background liposomal amphotericin
373489|NCT00419770|P1|Participant Flow|Deferasirox|Deferasirox plus liposomal amphotericin
373490|NCT00419770|O2|Outcome|Placebo|Placebo control plus background liposomal amphotericin
373491|NCT00419770|O1|Outcome|Deferasirox|Deferasirox plus liposomal amphotericin
373492|NCT00419770|E2|Reported Event|Placebo|Placebo control plus background liposomal amphotericin
373493|NCT00419770|E1|Reported Event|Deferasirox|Deferasirox plus liposomal amphotericin
373494|NCT00419926|B3|Baseline|Total|Total of all reporting groups
373495|NCT00419926|B2|Baseline|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
373496|NCT00419926|B1|Baseline|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
373497|NCT00419926|P2|Participant Flow|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
373498|NCT00419926|P1|Participant Flow|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
373499|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
373500|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
373501|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
373554|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
373555|NCT00420017|O2|Outcome|Control|Control usual care
373502|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
373503|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
373504|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
373505|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
373506|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
373507|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
378108|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
373508|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
373509|NCT00419926|E2|Reported Event|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
373510|NCT00419926|E1|Reported Event|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
373511|NCT00419952|B3|Baseline|Total|Total of all reporting groups
373512|NCT00419952|B2|Baseline|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373513|NCT00419952|B1|Baseline|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373514|NCT00419952|P2|Participant Flow|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373515|NCT00419952|P1|Participant Flow|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373516|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373517|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373518|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373519|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373520|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373521|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373522|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373523|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373524|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373525|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373526|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373527|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373528|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373529|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373530|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373531|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373532|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373533|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373534|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373535|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373536|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373537|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373538|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373539|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373540|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373541|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373542|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373543|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373544|NCT00419952|E2|Reported Event|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
373545|NCT00419952|E1|Reported Event|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
373546|NCT00420017|B3|Baseline|Total|Total of all reporting groups
373547|NCT00420017|B2|Baseline|Control|Control usual care
373548|NCT00420017|B1|Baseline|Amiodarone|Intravenous amiodarone
373549|NCT00420017|P2|Participant Flow|Control|Control usual care
373550|NCT00420017|P1|Participant Flow|Amiodarone|Intravenous amiodarone
373551|NCT00420017|O2|Outcome|Control|Control usual care
373561|NCT00420056|B1|Baseline|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373562|NCT00420056|P1|Participant Flow|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373563|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373564|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373565|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373566|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373567|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373568|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373569|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373570|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373571|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373572|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373573|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373574|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373575|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373576|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373752|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373577|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373578|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373579|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373580|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373581|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373582|NCT00420056|E1|Reported Event|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
373583|NCT00420095|B3|Baseline|Total|Total of all reporting groups
373584|NCT00420095|B2|Baseline|Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70|Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
373585|NCT00420095|B1|Baseline|Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix|Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
373586|NCT00420095|P2|Participant Flow|Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70|Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
373587|NCT00420095|P1|Participant Flow|Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix|Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
373588|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373589|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373590|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373591|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373592|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373593|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373594|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373595|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373596|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373597|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373598|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373599|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373600|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373601|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373602|NCT00420095|E2|Reported Event|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373603|NCT00420095|E1|Reported Event|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
373604|NCT00420147|B3|Baseline|Total|Total of all reporting groups
373605|NCT00420147|B2|Baseline|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a wedged in-shoe orthosis as their treatment.
373606|NCT00420147|B1|Baseline|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a neutral (non-wedged) in-shoe orthosis as their treatment.
373607|NCT00420147|P2|Participant Flow|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis and were prescribed a laterally wedged in shoe orthosis
373608|NCT00420147|P1|Participant Flow|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis and were prescribed a neutral in shoe orthosis
373609|NCT00420147|O2|Outcome|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis
373610|NCT00420147|O1|Outcome|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis
373611|NCT00420147|O2|Outcome|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis
373862|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
373612|NCT00420147|O1|Outcome|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis
373613|NCT00420147|E2|Reported Event|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis. They were prescribed and wore a laterally wedged in-shoe orthosis.
373614|NCT00420147|E1|Reported Event|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis. They were prescribed and wore a neutral in-shoe orthosis.
373615|NCT00420199|B3|Baseline|Total|Total of all reporting groups
373616|NCT00420199|B2|Baseline|Placebo (PLA) + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
373617|NCT00420199|B1|Baseline|Abatacept (ABA) + Methotrexate (MTX)|Abatacept was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg.
373618|NCT00420199|P2|Participant Flow|Placebo (PLA) + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
373710|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373711|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373619|NCT00420199|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX)|Abatacept was administered intravenously (IV) on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg.
373620|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373621|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373622|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373623|NCT00420199|O2|Outcome|Placebo (PLA) + MTX|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
373624|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373625|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373626|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373627|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373628|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373629|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373630|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373631|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373632|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373633|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373634|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373635|NCT00420199|O2|Outcome|Placebo (PLA) + MTX|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373636|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373698|NCT00420212|E2|Reported Event|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
373637|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373638|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373639|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373640|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373641|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373642|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373643|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373644|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373645|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373646|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373647|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373648|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373649|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373650|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373651|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373652|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373653|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373654|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373655|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373656|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373657|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373658|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373659|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373660|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373661|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
373662|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373663|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373664|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373665|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
373666|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373667|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
373668|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
373669|NCT00420199|E2|Reported Event|PLA + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
373670|NCT00420199|E1|Reported Event|ABA + MTX|Abatacept was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
373671|NCT00420212|B4|Baseline|Total|Total of all reporting groups
373672|NCT00420212|B3|Baseline|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
373673|NCT00420212|B2|Baseline|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
373674|NCT00420212|B1|Baseline|Placebo|Participants received two placebo capsules orally three times daily (TID)
373675|NCT00420212|P3|Participant Flow|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
373676|NCT00420212|P2|Participant Flow|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
373677|NCT00420212|P1|Participant Flow|Placebo|Participants received two placebo capsules orally three times daily (TID)
373678|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
373679|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
373680|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
373681|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
373682|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
373683|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
373684|NCT00420212|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
373685|NCT00420212|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
373686|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
373687|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
373688|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
373689|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
373690|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
373691|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
373692|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
373693|NCT00420212|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
373694|NCT00420212|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
373695|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
373696|NCT00420212|E4|Reported Event|Total BG00012|Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
373697|NCT00420212|E3|Reported Event|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
373751|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373699|NCT00420212|E1|Reported Event|Placebo|Participants received two placebo capsules orally three times daily (TID)
373700|NCT00420238|B3|Baseline|Total|Total of all reporting groups
373701|NCT00420238|B2|Baseline|Placebo|Subcutaneously (SC), once weekly
373702|NCT00420238|B1|Baseline|Etanercept|50 mg subcutaneously (SC), once weekly
373703|NCT00420238|P2|Participant Flow|Placebo/Etanercept|Placebo subcutaneously (SC), once weekly; Etanercept 50 mg SC, once weekly
373704|NCT00420238|P1|Participant Flow|Etanercept/Etanercept|Etanercept 50 mg subcutaneously (SC) once weekly
373705|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373706|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373707|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373708|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373709|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373713|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373714|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373715|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373716|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373717|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373718|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373719|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373720|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373721|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373722|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373723|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373724|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373725|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373726|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373727|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373728|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373729|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373730|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373731|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373732|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373733|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373734|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373735|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373736|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373737|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373738|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373739|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373740|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373741|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373742|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373743|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373744|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373745|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373746|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373747|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373748|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373749|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373750|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373753|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373754|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373755|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373756|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373757|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373758|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373759|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373760|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373761|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373762|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373763|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373764|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373765|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373766|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373767|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373768|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373769|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373770|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373771|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373772|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373773|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373774|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373775|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
373776|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373777|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373778|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373779|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373780|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373781|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373782|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373783|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373784|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373785|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373786|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373787|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373788|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373789|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373790|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373791|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373792|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373793|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373794|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373795|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373796|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373797|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373798|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373799|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373800|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373801|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373802|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373803|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373804|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373805|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373806|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373807|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373808|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373809|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
373810|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373811|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373812|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373813|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373814|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373815|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
373816|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373817|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373818|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373819|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
373820|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373821|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373822|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373823|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
373824|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373825|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373826|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373827|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
373828|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: etanercept 50 mg subcutaneously (SC), once weekly
373829|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373830|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373831|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373832|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373833|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
373834|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
373835|NCT00420238|E4|Reported Event|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
373836|NCT00420238|E3|Reported Event|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
373837|NCT00420238|E2|Reported Event|Placebo|Double-blind Period 1: placebo subcutaneously (SC), once weekly
373838|NCT00420238|E1|Reported Event|Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly
373839|NCT00420290|B3|Baseline|Total|Total of all reporting groups
373840|NCT00420290|B2|Baseline|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373841|NCT00420290|B1|Baseline|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373842|NCT00420290|P2|Participant Flow|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373843|NCT00420290|P1|Participant Flow|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373844|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373845|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373846|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373847|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373848|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373849|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373850|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373851|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373852|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373853|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373854|NCT00420290|E2|Reported Event|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373855|NCT00420290|E1|Reported Event|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
373856|NCT00420303|B3|Baseline|Total|Total of all reporting groups
373857|NCT00420303|B2|Baseline|Placebo|Subcutaneously once weekly
373858|NCT00420303|B1|Baseline|Etanercept|50mg subcutaneously once weekly
373859|NCT00420303|P2|Participant Flow|Placebo|Subcutaneously once weekly
373860|NCT00420303|P1|Participant Flow|Etanercept|50mg subcutaneously once weekly
373861|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
373868|NCT00420303|E1|Reported Event|Etanercept|50mg subcutaneously once weekly
373869|NCT00420316|B3|Baseline|Total|Total of all reporting groups
373870|NCT00420316|B2|Baseline|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373871|NCT00420316|B1|Baseline|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373872|NCT00420316|P2|Participant Flow|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373873|NCT00420316|P1|Participant Flow|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373874|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373875|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373876|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373877|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373878|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373879|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373880|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373881|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373882|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373883|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373884|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373885|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373886|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373887|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373888|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373889|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373924|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373890|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373891|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373892|NCT00420316|E2|Reported Event|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373893|NCT00420316|E1|Reported Event|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
373894|NCT00420342|B4|Baseline|Total|Total of all reporting groups
373895|NCT00420342|B3|Baseline|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373896|NCT00420342|B2|Baseline|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
379734|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
373897|NCT00420342|B1|Baseline|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373898|NCT00420342|P3|Participant Flow|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373899|NCT00420342|P2|Participant Flow|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373900|NCT00420342|P1|Participant Flow|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373901|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373902|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373903|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373904|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373905|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373906|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373907|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373908|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373909|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373910|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373911|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373912|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373913|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373914|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373915|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373916|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373917|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373918|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373919|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373920|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373921|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373922|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373923|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
378736|NCT00423358|B3|Baseline|Total|Total of all reporting groups
373925|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373926|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373927|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373928|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373929|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373930|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373931|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373932|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373933|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
378416|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
373934|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373935|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373936|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373937|NCT00420342|E3|Reported Event|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373938|NCT00420342|E2|Reported Event|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373939|NCT00420342|E1|Reported Event|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
373940|NCT00420407|B3|Baseline|Total|Total of all reporting groups
373941|NCT00420407|B2|Baseline|Vasopressin|"Vasopressin
vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
373942|NCT00420407|B1|Baseline|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added
normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
373943|NCT00420407|P2|Participant Flow|Vasopressin|"Vasopressin
vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
373944|NCT00420407|P1|Participant Flow|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added
normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
373945|NCT00420407|O2|Outcome|Vasopressin|
373946|NCT00420407|O1|Outcome|Normal Saline|
373947|NCT00420407|E2|Reported Event|Vasopressin|"Vasopressin
vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
373948|NCT00420407|E1|Reported Event|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added
normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
373949|NCT00420420|B3|Baseline|Total|Total of all reporting groups
373950|NCT00420420|B2|Baseline|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
373951|NCT00420420|B1|Baseline|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
373952|NCT00420420|P2|Participant Flow|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
373953|NCT00420420|P1|Participant Flow|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
373954|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
373955|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
373956|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
373957|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
373958|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
373959|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
373960|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
373961|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
373962|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
373963|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
373964|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
373965|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
373966|NCT00420420|E2|Reported Event|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
373967|NCT00420420|E1|Reported Event|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
380371|NCT00415597|E1|Reported Event|ALO-01|
373968|NCT00420459|B1|Baseline|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
373969|NCT00420459|P1|Participant Flow|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole, mean final dose was 9.8 mg /day.
373970|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
373971|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
373972|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
373973|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
373974|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole, mean final dose was 9.8 mg /day.
373975|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole. Mean final dose was 9.8 mg/day
373976|NCT00420459|E1|Reported Event|Aripiprazole|
373977|NCT00420511|B3|Baseline|Total|Total of all reporting groups
373978|NCT00420511|B2|Baseline|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
373979|NCT00420511|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
373980|NCT00420511|P2|Participant Flow|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
373981|NCT00420511|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
373982|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
373983|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
373984|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
373985|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
373986|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (orally administered)
373987|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (orally administered)
373988|NCT00420511|E2|Reported Event|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
373989|NCT00420511|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
373990|NCT00420628|B3|Baseline|Total|Total of all reporting groups
373991|NCT00420628|B2|Baseline|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
373992|NCT00420628|B1|Baseline|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
373993|NCT00420628|P2|Participant Flow|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
373994|NCT00420628|P1|Participant Flow|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
373995|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
373996|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
373997|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
373998|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
373999|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
374000|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
374001|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
374002|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
374003|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
374004|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
374005|NCT00420628|E2|Reported Event|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
374006|NCT00420628|E1|Reported Event|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
374007|NCT00420745|B3|Baseline|Total|Total of all reporting groups
374008|NCT00420745|B2|Baseline|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374009|NCT00420745|B1|Baseline|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374010|NCT00420745|P2|Participant Flow|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374011|NCT00420745|P1|Participant Flow|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374012|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374013|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374014|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374015|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374016|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374139|NCT00420927|P1|Participant Flow|ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
374017|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374018|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374019|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374020|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374021|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374022|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374023|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374024|NCT00420745|E2|Reported Event|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374025|NCT00420745|E1|Reported Event|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
374026|NCT00420784|B5|Baseline|Total|Total of all reporting groups
385858|NCT00448123|B1|Baseline|Placebo|Placebo Group
374027|NCT00420784|B4|Baseline|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374028|NCT00420784|B3|Baseline|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
374029|NCT00420784|B2|Baseline|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374030|NCT00420784|B1|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
374031|NCT00420784|P4|Participant Flow|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374032|NCT00420784|P3|Participant Flow|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
374033|NCT00420784|P2|Participant Flow|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374034|NCT00420784|P1|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
374035|NCT00420784|O1|Outcome|Telaprevir|"All subjects who received single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week reporting group and for 24 weeks in Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week and Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week reporting groups."
374036|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374037|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
374038|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374039|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
374040|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374268|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
374041|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
374042|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374043|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
374044|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
388829|NCT00447382|B3|Baseline|Total|Total of all reporting groups
374045|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
374046|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374047|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
374048|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374049|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
374050|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374051|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
374052|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374053|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
374054|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374055|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
374056|NCT00420784|E4|Reported Event|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374057|NCT00420784|E3|Reported Event|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
374058|NCT00420784|E2|Reported Event|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
374130|NCT00420927|B3|Baseline|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374059|NCT00420784|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
374060|NCT00420849|B1|Baseline|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
374061|NCT00420849|P1|Participant Flow|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
374221|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374062|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374063|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374064|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374065|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374066|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374067|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374068|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374069|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374070|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374071|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374072|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374269|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
374073|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374074|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374145|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374146|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374075|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374076|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374077|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374078|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374079|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374080|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374081|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374082|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374083|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374084|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374085|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374131|NCT00420927|B2|Baseline|PBO+MTX|Methotrexate (MTX) monotherapy plus blinded placebo(PBO) during Period 1
374132|NCT00420927|B1|Baseline|ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
374133|NCT00420927|P7|Participant Flow|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374086|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374087|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374088|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374089|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374090|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374091|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374092|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374093|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374094|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374095|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374096|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374097|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374098|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374134|NCT00420927|P6|Participant Flow|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374135|NCT00420927|P5|Participant Flow|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374270|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
374099|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374100|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374101|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374102|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374103|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374104|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374105|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374106|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374107|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374108|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374109|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374110|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374111|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374136|NCT00420927|P4|Participant Flow|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374137|NCT00420927|P3|Participant Flow|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374271|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
374112|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374113|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374114|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374115|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374116|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
374117|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
374118|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
374119|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
374120|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
374121|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
374122|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
374123|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
374124|NCT00420849|E1|Reported Event|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
374125|NCT00420927|B8|Baseline|Total|Total of all reporting groups
374126|NCT00420927|B7|Baseline|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374127|NCT00420927|B6|Baseline|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374128|NCT00420927|B5|Baseline|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374129|NCT00420927|B4|Baseline|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374138|NCT00420927|P2|Participant Flow|PBO+MTX|Methotrexate (MTX) monotherapy plus blinded placebo during Period 1
374140|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374141|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374142|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374143|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374144|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
378417|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
374147|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374148|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374149|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374150|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374151|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374152|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374153|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374154|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374155|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374156|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374157|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374158|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374159|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374160|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374161|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374162|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374163|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374164|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374165|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374166|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374167|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374168|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374169|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374170|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374171|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374172|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374173|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374174|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374175|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374176|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374272|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
374177|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374178|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374179|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374180|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374181|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374182|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374183|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374184|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374185|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374186|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374187|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374188|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374189|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374190|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374191|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374192|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374193|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374194|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374195|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374196|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374197|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374198|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374199|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374200|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374201|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374202|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374203|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374204|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374205|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374206|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374207|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374208|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374209|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374210|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374211|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374212|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374213|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374273|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
374214|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374215|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374216|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374217|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374218|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374219|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374220|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374222|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374223|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374224|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374225|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374226|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374227|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374228|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374229|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374230|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
374231|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
374232|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
374233|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
374234|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
374235|NCT00420927|E7|Reported Event|Period 1 PBO+MTX|Combination therapy with methotrexate (MTX) and blinded placebo (PBO) during Period 1
374236|NCT00420927|E6|Reported Event|Period 1 ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
374237|NCT00420927|E5|Reported Event|PBO+MTX/OL ADA+MTX (Arm 5)|Blinded MTX monotherapy during Period 1, open-label combination therapy during Period 2
374238|NCT00420927|E4|Reported Event|PBO+MTX/PBO+MTX (Arm 4)|Blinded MTX monotherapy during Period 1 and Period 2
374239|NCT00420927|E3|Reported Event|ADA+MTX/OL ADA+MTX (Arm 3)|Blinded combination therapy during Period 1, open-label combination therapy during Period 2
374240|NCT00420927|E2|Reported Event|ADA+MTX/ADA+MTX (Arm 2)|Blinded combination ADA+MTX therapy during Period 1 and Period 2
374241|NCT00420927|E1|Reported Event|ADA+MTX/PBO+MTX (Arm 1)|Blinded combination ADA+MTX therapy during Period 1 and blinded MTX monotherapy during Period 2
374242|NCT00420992|B3|Baseline|Total|Total of all reporting groups
374243|NCT00420992|B2|Baseline|Placebo|
374244|NCT00420992|B1|Baseline|ALO-01|
374245|NCT00420992|P2|Participant Flow|Placebo|
374246|NCT00420992|P1|Participant Flow|ALO-01|
374247|NCT00420992|O2|Outcome|Placebo|
374248|NCT00420992|O1|Outcome|ALO-01|
374249|NCT00420992|E3|Reported Event|Titration ALO-01|Open-label ALO-01
374250|NCT00420992|E2|Reported Event|Placebo|
374251|NCT00420992|E1|Reported Event|ALO-01|
374252|NCT00421174|B3|Baseline|Total|Total of all reporting groups
374253|NCT00421174|B2|Baseline|Placebo|Placebo plus Corticosteroids
374254|NCT00421174|B1|Baseline|Etanercept|Etanercept plus corticosteroids
374255|NCT00421174|P2|Participant Flow|Placebo|Placebo plus Corticosteroids
374256|NCT00421174|P1|Participant Flow|Etanercept|Etanercept plus corticosteroids
374257|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
374258|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
374259|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
374260|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
374261|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
374262|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
374263|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
374264|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
374265|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
374266|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
374267|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
374282|NCT00421174|E1|Reported Event|Etanercept|Etanercept plus corticosteroids
374283|NCT00421343|B1|Baseline|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
374284|NCT00421343|P1|Participant Flow|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
374285|NCT00421343|O1|Outcome|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
374286|NCT00421343|E1|Reported Event|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
374287|NCT00421408|B3|Baseline|Total|Total of all reporting groups
374288|NCT00421408|B2|Baseline|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).
Whey protein supplement : 40-g whey protein supplement daily for 18 months"
374289|NCT00421408|B1|Baseline|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).
Placebo : Placebo supplement daily for 18 months"
374290|NCT00421408|P2|Participant Flow|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).
Whey protein supplement : 40-g whey protein supplement daily for 18 months"
378418|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
374291|NCT00421408|P1|Participant Flow|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).
Placebo : Placebo supplement daily for 18 months"
374292|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).
Whey protein supplement : 40-g whey protein supplement daily for 18 months"
374293|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).
Placebo : Placebo supplement daily for 18 months"
374294|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).
Whey protein supplement : 40-g whey protein supplement daily for 18 months"
374295|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).
Placebo : Placebo supplement daily for 18 months"
374296|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).
Whey protein supplement : 40-g whey protein supplement daily for 18 months"
374297|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).
Placebo : Placebo supplement daily for 18 months"
374298|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).
Whey protein supplement : 40-g whey protein supplement daily for 18 months"
374299|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).
Placebo : Placebo supplement daily for 18 months"
374300|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).
Whey protein supplement : 40-g whey protein supplement daily for 18 months"
374301|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).
Placebo : Placebo supplement daily for 18 months"
374302|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).
Whey protein supplement : 40-g whey protein supplement daily for 18 months"
374303|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).
Placebo : Placebo supplement daily for 18 months"
374304|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).
Whey protein supplement : 40-g whey protein supplement daily for 18 months"
374305|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).
Placebo : Placebo supplement daily for 18 months"
374306|NCT00421408|E2|Reported Event|Protein Powder 40 g Daily|
374307|NCT00421408|E1|Reported Event|Placebo Carbohydrate Powder 40 g Daily|
374308|NCT00411749|B3|Baseline|Total|Total of all reporting groups
374309|NCT00411749|B2|Baseline|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
374310|NCT00411749|B1|Baseline|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
374311|NCT00411749|P2|Participant Flow|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
374312|NCT00411749|P1|Participant Flow|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
374313|NCT00411749|O4|Outcome|V501-HPV 18|HPV 18 serum antibody titer measured in V501 vaccination group
374314|NCT00411749|O3|Outcome|V501-HPV 16|HPV 16 serum antibody titer measured in V501 vaccination group
374315|NCT00411749|O2|Outcome|V501-HPV 11|HPV 11 serum antibody titer measured in V501 vaccination group
374316|NCT00411749|O1|Outcome|V501-HPV 6|HPV 6 serum antibody titer measured in V501 vaccination group
374317|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
374318|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
374319|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
374320|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
374321|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
374322|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
374323|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
374599|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
374324|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
374325|NCT00411749|E2|Reported Event|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
374326|NCT00411749|E1|Reported Event|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
374327|NCT00411762|B1|Baseline|PHY906 Administration|PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
374328|NCT00411762|P1|Participant Flow|PHY906 Administration|"PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
Capecitabine
PHY906"
374329|NCT00411762|O1|Outcome|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
374330|NCT00411762|O1|Outcome|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
374331|NCT00411762|E1|Reported Event|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
374359|NCT00412061|E3|Reported Event|Everolimus Open Label|Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
374332|NCT00411788|B1|Baseline|Rapamycin and Trastuzumab|Patients received oral rapamycin/sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
374333|NCT00411788|P1|Participant Flow|Rapamycin and Trastuzumab|Patients received oral rapamycin/sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
374334|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
374335|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
374336|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
374337|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
374338|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
374339|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
374340|NCT00411788|E1|Reported Event|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
374342|NCT00412061|B2|Baseline|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
374343|NCT00412061|B1|Baseline|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
374379|NCT00412074|E2|Reported Event|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
374344|NCT00412061|P2|Participant Flow|Octreotide+ Placebo Followed by Open Label Arm|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
374345|NCT00412061|P1|Participant Flow|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
374346|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
374347|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
374348|NCT00412061|O1|Outcome|Everolimus Open Label Arm|Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
374349|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
374350|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
374351|NCT00412061|O2|Outcome|Octreotide+ Placebo Followed by Open Label Arm|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
374352|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
374353|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
374354|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
374355|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
374356|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
374425|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374357|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
374358|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
374360|NCT00412061|E2|Reported Event|Placebo + Octreotide|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
374361|NCT00412061|E1|Reported Event|Everolimus + Octreotide|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
374362|NCT00412074|B4|Baseline|Total|Total of all reporting groups
374363|NCT00412074|B3|Baseline|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
374364|NCT00412074|B2|Baseline|2400 Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
374365|NCT00412074|B1|Baseline|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
374366|NCT00412074|P3|Participant Flow|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
374367|NCT00412074|P2|Participant Flow|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
374368|NCT00412074|P1|Participant Flow|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
374369|NCT00412074|O3|Outcome|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
6400 IU Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
374370|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
2400 IU Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
374371|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
400 IU Vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant"
374372|NCT00412074|O3|Outcome|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
6400 IU Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
374373|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
2400 IU Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
374374|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
400 IU Vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant"
374375|NCT00412074|O3|Outcome|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
374426|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374600|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
374376|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
374377|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
374378|NCT00412074|E3|Reported Event|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
374536|NCT00412425|B3|Baseline|Total|Total of all reporting groups
374380|NCT00412074|E1|Reported Event|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
374381|NCT00412087|B3|Baseline|Total|Total of all reporting groups
374382|NCT00412087|B2|Baseline|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day
cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
374383|NCT00412087|B1|Baseline|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.
cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
374384|NCT00412087|P2|Participant Flow|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day
cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
374385|NCT00412087|P1|Participant Flow|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.
cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
374386|NCT00412087|O2|Outcome|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day
cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
374387|NCT00412087|O1|Outcome|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.
cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
374388|NCT00412087|O2|Outcome|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day
cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
374389|NCT00412087|O1|Outcome|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.
cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
374390|NCT00412087|E2|Reported Event|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day
cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
374427|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374428|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374391|NCT00412087|E1|Reported Event|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.
cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
374392|NCT00412113|B3|Baseline|Total|Total of all reporting groups
374393|NCT00412113|B2|Baseline|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374394|NCT00412113|B1|Baseline|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374395|NCT00412113|P2|Participant Flow|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374537|NCT00412425|B2|Baseline|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
390475|NCT00459316|B5|Baseline|Total|Total of all reporting groups
374396|NCT00412113|P1|Participant Flow|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374397|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374398|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374399|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374400|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374401|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374402|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374403|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374404|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374405|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374406|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374407|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374408|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374409|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374410|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374411|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374412|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374413|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374414|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374415|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374416|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374417|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374418|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374419|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374420|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374421|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374422|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374423|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374424|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374429|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374430|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374431|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374432|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374433|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374434|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374538|NCT00412425|B1|Baseline|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
374435|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374436|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374437|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374438|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374439|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374440|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374441|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374442|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374443|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374444|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374445|NCT00412113|E2|Reported Event|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
374446|NCT00412113|E1|Reported Event|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
374447|NCT00412217|B3|Baseline|Total|Total of all reporting groups
374448|NCT00412217|B2|Baseline|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
374449|NCT00412217|B1|Baseline|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
374450|NCT00412217|P2|Participant Flow|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
374451|NCT00412217|P1|Participant Flow|Erlotinib|Participants with histologically confirmed advanced squamous cell carcinoma (SCC) of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 milligrams (mg) once daily for 1 year until disease progression or intolerable toxicity.
374452|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
374453|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
374454|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
374455|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
374456|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
374457|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
374458|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
380372|NCT00415610|B4|Baseline|Total|Total of all reporting groups
374459|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
374460|NCT00412217|E2|Reported Event|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
374461|NCT00412217|E1|Reported Event|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
374462|NCT00412243|B1|Baseline|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days
Clofarabine : 40 mg/m^2 Daily for 3 Days
Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
374463|NCT00412243|P1|Participant Flow|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days
Clofarabine : 40 mg/m^2 Daily for 3 Days
Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
374464|NCT00412243|O1|Outcome|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days
Clofarabine : 40 mg/m^2 Daily for 3 Days
Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
374465|NCT00412243|E1|Reported Event|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days
Clofarabine : 40 mg/m^2 Daily for 3 Days
Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
374466|NCT00412360|B3|Baseline|Total|Total of all reporting groups
374467|NCT00412360|B2|Baseline|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374468|NCT00412360|B1|Baseline|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374469|NCT00412360|P2|Participant Flow|Double UCB Transplant|Double Cord Blood Unit Transplantation: Unrelated donor, double cord blood unit
374470|NCT00412360|P1|Participant Flow|Single UCB Transplant|Single Cord Blood Unit Transplantation: Unrelated donor, single cord blood unit
374471|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374472|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374473|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374474|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374475|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374476|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374477|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374478|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374479|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374480|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374481|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374482|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374483|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374484|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374485|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374486|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374487|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374488|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374489|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374490|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374491|NCT00412360|E2|Reported Event|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
374492|NCT00412360|E1|Reported Event|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
374493|NCT00412373|B3|Baseline|Total|Total of all reporting groups
374494|NCT00412373|B2|Baseline|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374495|NCT00412373|B1|Baseline|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374496|NCT00412373|P2|Participant Flow|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374497|NCT00412373|P1|Participant Flow|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374588|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
374589|NCT00412516|E3|Reported Event|Group 3|Measles vaccine followed by SA 14-14-2 one month later
374601|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
380400|NCT00415623|O2|Outcome|Week 4|
374498|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374499|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374539|NCT00412425|P2|Participant Flow|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
374540|NCT00412425|P1|Participant Flow|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
374541|NCT00412425|O2|Outcome|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
374542|NCT00412425|O1|Outcome|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
374500|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374501|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374502|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374503|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374504|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374505|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374506|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374507|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374508|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374509|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374510|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374511|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374512|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374513|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374514|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374515|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374590|NCT00412516|E2|Reported Event|Group 2|"Measles and SA 14-14-2 given concurrently
Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
374591|NCT00412516|E1|Reported Event|Group 1|SA 14-14-2 followed by measles vaccine one month later
374592|NCT00412529|B3|Baseline|Total|Total of all reporting groups
374593|NCT00412529|B2|Baseline|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
374516|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374517|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374518|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374519|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374520|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374521|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374522|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374523|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374524|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374525|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374526|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374527|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374528|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374529|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374530|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374531|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374532|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374533|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374594|NCT00412529|B1|Baseline|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
374595|NCT00412529|P2|Participant Flow|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
374596|NCT00412529|P1|Participant Flow|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
374597|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
374598|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
374534|NCT00412373|E2|Reported Event|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
374535|NCT00412373|E1|Reported Event|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
374547|NCT00412451|B3|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
374548|NCT00412451|B2|Baseline|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
374549|NCT00412451|B1|Baseline|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
374550|NCT00412451|P4|Participant Flow|Sham Injection|Sham intravitreal injection
374551|NCT00412451|P3|Participant Flow|0criplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
374552|NCT00412451|P2|Participant Flow|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
374553|NCT00412451|P1|Participant Flow|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injections versus sham injection
374554|NCT00412451|O4|Outcome|Sham Injection|"Sham injection
Sham injection : Sham intravitreal injection"
374555|NCT00412451|O3|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
374556|NCT00412451|O2|Outcome|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
374557|NCT00412451|O1|Outcome|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
374558|NCT00412451|E4|Reported Event|Sham Injection|"Sham injection
Sham injection : Sham intravitreal injection"
374559|NCT00412451|E3|Reported Event|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
374560|NCT00412451|E2|Reported Event|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
374561|NCT00412451|E1|Reported Event|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
374562|NCT00412464|B1|Baseline|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
374563|NCT00412464|P1|Participant Flow|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
374564|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
374565|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
374566|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
374567|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
374568|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
374569|NCT00412464|E1|Reported Event|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
374570|NCT00412516|B4|Baseline|Total|Total of all reporting groups
374571|NCT00412516|B3|Baseline|Group 3|Measles vaccine followed by SA 14-14-2 one month later
374572|NCT00412516|B2|Baseline|Group 2|Measles and SA 14-14-2 given concurrently
374573|NCT00412516|B1|Baseline|Group 1|SA 14-14-2 followed by measles vaccine one month later
374574|NCT00412516|P3|Participant Flow|Group 3|Measles vaccine followed by SA 14-14-2 one month later
374575|NCT00412516|P2|Participant Flow|Group 2|"Measles and SA 14-14-2 given concurrently
Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
374576|NCT00412516|P1|Participant Flow|Group 1|SA 14-14-2 followed by measles vaccine one month later
374577|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
374578|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently
Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
374579|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
374580|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
374581|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently
Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
374582|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
374583|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
374584|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently
Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
374585|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
374586|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
374587|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently
Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
374602|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
374603|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
374604|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
374605|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
374606|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
374607|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
374608|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
374609|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
374610|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
374611|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
374612|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
374613|NCT00412529|E2|Reported Event|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
374614|NCT00412529|E1|Reported Event|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
374615|NCT00412542|B3|Baseline|Total|Total of all reporting groups
374616|NCT00412542|B2|Baseline|Anaplastic Gliomas: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
374617|NCT00412542|B1|Baseline|Glioblastoma Multiforme: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
378419|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
374618|NCT00412542|P2|Participant Flow|Anaplastic Gliomas: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
374619|NCT00412542|P1|Participant Flow|Glioblastoma Multiforme: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
374620|NCT00412542|O1|Outcome|Participants With Recurrent Malignant Gliomas|The endpoints combined results of all strata (Arm 1 of Glioblastoma Multiforme: Thalidomide + CPT-11 and Arm 2 of Anaplastic Gliomas: Thalidomide + CPT-11).
374621|NCT00412542|E1|Reported Event|Patients With Recurrent Malignant Gliomas|The endpoints combined results of all strata
374622|NCT00412607|B1|Baseline|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
374623|NCT00412607|P1|Participant Flow|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
374624|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
374625|NCT00412607|O3|Outcome|Reported No Recurrence|Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
374626|NCT00412607|O2|Outcome|Reported Recurrence|Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
374627|NCT00412607|O1|Outcome|Total|Total number of subjects who completed 12-month, 2-year, and 3-year follow-up respectively.
374628|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
374629|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
374630|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
374631|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
374632|NCT00412607|E1|Reported Event|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
374633|NCT00421603|B3|Baseline|Total|Total of all reporting groups
374634|NCT00421603|B2|Baseline|Placebo|Placebo daily dose
374635|NCT00421603|B1|Baseline|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
374636|NCT00421603|P2|Participant Flow|Placebo|Placebo daily dose
374637|NCT00421603|P1|Participant Flow|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
374638|NCT00421603|O2|Outcome|Placebo|Placebo daily dose
374639|NCT00421603|O1|Outcome|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
374640|NCT00421603|E2|Reported Event|Placebo|Placebo daily dose
374641|NCT00421603|E1|Reported Event|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
374642|NCT00421733|B4|Baseline|Total|Total of all reporting groups
374643|NCT00421733|B3|Baseline|Placebo|Two placebo capsules per dose
374644|NCT00421733|B2|Baseline|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
374645|NCT00421733|B1|Baseline|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
374646|NCT00421733|P3|Participant Flow|Placebo|Two placebo capsules per dose
374647|NCT00421733|P2|Participant Flow|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
374648|NCT00421733|P1|Participant Flow|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
374649|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
374650|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
374651|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
374652|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
374653|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
374654|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
374656|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
374657|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
374658|NCT00421733|O4|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
374659|NCT00421733|O3|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
374660|NCT00421733|O2|Outcome|Combined Paricalcitol 1 Mcg and 2 Mcg|Combined participants in the 1 mcg and 2 mcg paricalcitol groups (N=92+92=184).
374661|NCT00421733|O1|Outcome|Placebo|Two placebo capsules per dose (N=88)
374662|NCT00421733|E3|Reported Event|Placebo|Two placebo capsules per dose
374663|NCT00421733|E2|Reported Event|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
374664|NCT00421733|E1|Reported Event|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
374665|NCT00424255|B3|Baseline|Total|Total of all reporting groups
374666|NCT00424255|B2|Baseline|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
392122|NCT00462670|B3|Baseline|Total|Total of all reporting groups
374667|NCT00424255|B1|Baseline|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374668|NCT00424255|P2|Participant Flow|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374669|NCT00424255|P1|Participant Flow|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374670|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374671|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374672|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374673|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374674|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374735|NCT00424294|P1|Participant Flow|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374675|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374676|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374740|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374934|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
393882|NCT00471068|B3|Baseline|Total|Total of all reporting groups
374677|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374678|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374679|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374680|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374681|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374682|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374683|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374684|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374685|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374736|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374686|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374687|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374688|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374689|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374690|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374691|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374692|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374693|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374694|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374695|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374696|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374758|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374697|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374698|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
393883|NCT00471068|B2|Baseline|Cosopt|
374699|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374700|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374701|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374702|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374703|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374704|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374705|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374706|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374707|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374780|NCT00424294|E2|Reported Event|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374708|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374709|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374710|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374711|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374712|NCT00424255|E2|Reported Event|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374713|NCT00424255|E1|Reported Event|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
374714|NCT00424268|B3|Baseline|Total|Total of all reporting groups
374715|NCT00424268|B2|Baseline|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
374716|NCT00424268|B1|Baseline|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
374717|NCT00424268|P2|Participant Flow|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
374718|NCT00424268|P1|Participant Flow|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
374719|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
374720|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
374721|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
374722|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
374723|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
374724|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
374725|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
374726|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
374727|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
374728|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
374729|NCT00424268|E2|Reported Event|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
374730|NCT00424268|E1|Reported Event|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
374731|NCT00424294|B3|Baseline|Total|Total of all reporting groups
374732|NCT00424294|B2|Baseline|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374733|NCT00424294|B1|Baseline|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374734|NCT00424294|P2|Participant Flow|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374922|NCT00424398|P2|Participant Flow|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
376297|NCT00417417|O2|Outcome|Placebo|Placebo subcutaneous injection x 4 over 8 weeks
374737|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374738|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374739|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374932|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374741|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374742|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374743|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374744|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374745|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374746|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374747|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374748|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374749|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374750|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374751|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374752|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374753|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374754|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374755|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374756|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374757|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374923|NCT00424398|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374759|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374760|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374761|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374762|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374763|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374764|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374765|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374766|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374767|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374768|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374769|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374770|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374771|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374772|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374773|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374774|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374775|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374776|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374777|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374778|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
374779|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374924|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374781|NCT00424294|E1|Reported Event|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
374782|NCT00424346|B5|Baseline|Total|Total of all reporting groups
374783|NCT00424346|B4|Baseline|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374784|NCT00424346|B3|Baseline|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374969|NCT00424476|B1|Baseline|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374785|NCT00424346|B2|Baseline|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374786|NCT00424346|B1|Baseline|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374787|NCT00424346|P4|Participant Flow|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374788|NCT00424346|P3|Participant Flow|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374789|NCT00424346|P2|Participant Flow|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374790|NCT00424346|P1|Participant Flow|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks. Participants in this treatment group who participated in the Extension Phase are represented in the 'Canakinumab 300 mg q2wk' treatment group in the Extension Phase table below.
374791|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374792|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374793|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374794|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374795|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374796|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374797|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374798|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374799|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374925|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374800|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374801|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374802|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
393884|NCT00471068|B1|Baseline|Travatan|
374803|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374804|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374805|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374806|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374807|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374808|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374809|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374810|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374811|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374812|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374813|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374814|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374815|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374816|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374817|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374818|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374819|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374820|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374821|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374822|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374823|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374824|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374825|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374826|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374827|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374828|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374829|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
374830|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374831|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374832|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374833|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374834|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374835|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374836|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374837|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374838|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374839|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374840|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
375044|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
374841|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374842|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374843|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374844|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374845|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374846|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374847|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374848|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374849|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374850|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374851|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374852|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374853|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374854|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374855|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374856|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374926|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
385513|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
374857|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374858|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374859|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374860|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374861|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374862|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374863|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374864|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374865|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374866|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374867|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374868|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374869|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374870|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374871|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374872|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374873|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374874|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374875|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374927|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374876|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374877|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374878|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374879|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374880|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374881|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374882|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374883|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374884|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374885|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374886|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374887|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374888|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374889|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374890|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374891|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374892|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374893|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374894|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374928|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
376298|NCT00417417|O1|Outcome|Rilonacept|Rilonacept 320 mg subcutaneously x4 over 8 weeks
374895|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374896|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
374933|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
375045|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
374897|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
374898|NCT00424346|E4|Reported Event|Placebo|Placebo
374899|NCT00424346|E3|Reported Event|ACZ885 150mg sc q4wk|ACZ885 150mg sc q4wk
374900|NCT00424346|E2|Reported Event|ACZ885 300mg sc q2wk|ACZ885 300mg sc q2wk
374901|NCT00424346|E1|Reported Event|ACZ885 600mg iv + 300mg sc q2wk|ACZ885 600mg iv + 300mg sc q2wk
374902|NCT00424372|B1|Baseline|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
374903|NCT00424372|P1|Participant Flow|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
374904|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
374905|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
374906|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
374907|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
374908|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
374909|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
374910|NCT00424385|B1|Baseline|Arm 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
374911|NCT00424385|P1|Participant Flow|Imatinib + Sorafenib|"Both drugs, Gleevec + Sorafenib are given to all patients on study. There are 4 potential cohorts. Each will enroll 3 evaluable (patients that complete 2 cycles of treatment) patients. If a Dose Limiting Toxicity is demonstrated in a cohort, an additional 3 evaluable patients can be enrolled in that cohort.
Cohort 0 was 400mg Sorafenib every day (QD)and 300mg of Imatinib QD. Cohort 1 was 400mg Sorafenib two times a day and 300mg QD Imatinib."
374912|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0 & 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
374913|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0 & 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
374914|NCT00424385|O2|Outcome|Imatinib + Sorafenib Cohort 1|300mg every day (QD) Imatinib + 400mg twice daily (BID)Sorafenib, by mouth
374915|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0|300mg every day (QD)Imatinib + 400mg every day (QD) Sorafenib, by mouth
374916|NCT00424385|E1|Reported Event|Arm 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
374917|NCT00424398|B4|Baseline|Total|Total of all reporting groups
374918|NCT00424398|B3|Baseline|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374919|NCT00424398|B2|Baseline|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374920|NCT00424398|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374921|NCT00424398|P3|Participant Flow|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374929|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374930|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374931|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
375046|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
374935|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374936|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374937|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374938|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374939|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374940|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374941|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374942|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374943|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374944|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374945|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374946|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374947|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374948|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374949|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374950|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374951|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374952|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374953|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374954|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374955|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374956|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374957|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374958|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374959|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374960|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374961|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374962|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
375002|NCT00424502|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
374963|NCT00424398|E3|Reported Event|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374964|NCT00424398|E2|Reported Event|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374965|NCT00424398|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
374966|NCT00424476|B4|Baseline|Total|Total of all reporting groups
374967|NCT00424476|B3|Baseline|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374968|NCT00424476|B2|Baseline|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
375047|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
374970|NCT00424476|P3|Participant Flow|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374971|NCT00424476|P2|Participant Flow|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374972|NCT00424476|P1|Participant Flow|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374973|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374974|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374975|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374976|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374977|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374978|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374979|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374980|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374981|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374982|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374983|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374984|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374985|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374986|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374987|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374988|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374989|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374990|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374991|NCT00424476|E3|Reported Event|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374992|NCT00424476|E2|Reported Event|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374993|NCT00424476|E1|Reported Event|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
374994|NCT00424502|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
374995|NCT00424502|P1|Participant Flow|Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg intravenously (IV) and methylprednisolone 100 mg IV on Days 0 and 14.
374996|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
374997|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
374998|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
374999|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
375000|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
375001|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
375003|NCT00424515|B3|Baseline|Total|Total of all reporting groups
375004|NCT00424515|B2|Baseline|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375005|NCT00424515|B1|Baseline|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375006|NCT00424515|P2|Participant Flow|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375048|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375007|NCT00424515|P1|Participant Flow|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375008|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375009|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375010|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375011|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375012|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375013|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375014|NCT00424515|E2|Reported Event|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375015|NCT00424515|E1|Reported Event|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
375016|NCT00424528|B4|Baseline|Total|Total of all reporting groups
375017|NCT00424528|B3|Baseline|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375018|NCT00424528|B2|Baseline|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375019|NCT00424528|B1|Baseline|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375020|NCT00424528|P3|Participant Flow|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375021|NCT00424528|P2|Participant Flow|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375022|NCT00424528|P1|Participant Flow|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375023|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375024|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375025|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375026|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375027|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375028|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375029|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375030|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375031|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375032|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375033|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375034|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
376299|NCT00417417|O2|Outcome|Placebo|Placebo x 4 injections over 8 weeks
375035|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375036|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375037|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375038|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375039|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375040|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375041|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375042|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375043|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375049|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375050|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375051|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375052|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375053|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375054|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375055|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375056|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375057|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375058|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375059|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375060|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375061|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375062|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375063|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375064|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375065|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375066|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375067|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375068|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375069|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375070|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375071|NCT00424528|E3|Reported Event|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
375072|NCT00424528|E2|Reported Event|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
375073|NCT00424528|E1|Reported Event|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
375074|NCT00424554|B3|Baseline|Total|Total of all reporting groups
375075|NCT00424554|B2|Baseline|No Intervention|No pre-surgery treatment with temozolomide
375076|NCT00424554|B1|Baseline|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
375077|NCT00424554|P2|Participant Flow|No Intervention|No pre-surgery treatment with temozolomide
375078|NCT00424554|P1|Participant Flow|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
375079|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
375080|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
375081|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
375082|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
375083|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
375084|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
375085|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
375170|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375086|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
375087|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
375088|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
375089|NCT00424554|E2|Reported Event|No Intervention|No pre-surgery treatment with temozolomide
375090|NCT00424554|E1|Reported Event|Temozolomide|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
375091|NCT00424593|B3|Baseline|Total|Total of all reporting groups
375092|NCT00424593|B2|Baseline|Placebo|every day (QD), by mouth (PO), 13 weeks
375093|NCT00424593|B1|Baseline|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375094|NCT00424593|P2|Participant Flow|Placebo|every day (QD), by mouth (PO), 13 weeks
375095|NCT00424593|P1|Participant Flow|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
393885|NCT00471068|P2|Participant Flow|Cosopt|
375096|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375097|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375098|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375099|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375100|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375101|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375102|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375103|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375104|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375105|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375106|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375107|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375108|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375109|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375110|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375111|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375112|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375113|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375114|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375115|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375116|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375117|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375118|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375119|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375120|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375121|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375122|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375123|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375124|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375125|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375126|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375127|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375128|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375129|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375130|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375131|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375133|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375134|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
375135|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375136|NCT00424593|E2|Reported Event|Placebo|every day (QD), by mouth (PO), 13 weeks
375137|NCT00424593|E1|Reported Event|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
375138|NCT00424619|B4|Baseline|Total|Total of all reporting groups
375139|NCT00424619|B3|Baseline|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375140|NCT00424619|B2|Baseline|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375141|NCT00424619|B1|Baseline|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375142|NCT00424619|P3|Participant Flow|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375143|NCT00424619|P2|Participant Flow|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375144|NCT00424619|P1|Participant Flow|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375145|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375146|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375147|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375148|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375149|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375150|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375151|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375152|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375153|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375154|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375155|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375156|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375157|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375158|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375159|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375160|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375161|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375162|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375163|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375164|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375165|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375166|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375167|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375168|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375169|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375171|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375172|NCT00424619|E3|Reported Event|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
375173|NCT00424619|E2|Reported Event|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375174|NCT00424619|E1|Reported Event|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
375175|NCT00424632|B3|Baseline|Total|Total of all reporting groups
375176|NCT00424632|B2|Baseline|PF-03814735 (Schedule B)|Participants received daily dosing of PF-03814735 of 40, 50, or 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375177|NCT00424632|B1|Baseline|PF-03814735 (Schedule A)|Participants received daily dosing of PF-03814735 of 5, 10, 20, 40, 60, 80, or 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375178|NCT00424632|P10|Participant Flow|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375179|NCT00424632|P9|Participant Flow|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375180|NCT00424632|P8|Participant Flow|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
393886|NCT00471068|P1|Participant Flow|Travatan|
375181|NCT00424632|P7|Participant Flow|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375182|NCT00424632|P6|Participant Flow|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375183|NCT00424632|P5|Participant Flow|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375184|NCT00424632|P4|Participant Flow|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375185|NCT00424632|P3|Participant Flow|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375186|NCT00424632|P2|Participant Flow|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375187|NCT00424632|P1|Participant Flow|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375188|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375189|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375190|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375191|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375192|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375193|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375194|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375195|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375196|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375197|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375198|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375199|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375200|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375201|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375317|NCT00424645|B3|Baseline|Total|Total of all reporting groups
375318|NCT00424645|B2|Baseline|Placebo|Placebo administered IV following Voraxaze arm.
375202|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375203|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375204|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375205|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375206|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375207|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375208|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375407|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
393887|NCT00471068|O2|Outcome|Cosopt|
375209|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375210|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375211|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375212|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375213|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375214|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375215|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375216|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375217|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375218|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375219|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375220|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375221|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375222|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375223|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375224|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375225|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375226|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375227|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375228|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375229|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375230|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375319|NCT00424645|B1|Baseline|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
375231|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
375232|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375233|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375234|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375235|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375236|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375408|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375237|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375238|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375239|NCT00424632|O3|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375240|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375241|NCT00424632|O1|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375242|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375243|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375244|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375245|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
375246|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375247|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375248|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375249|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375250|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375251|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375252|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375253|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375254|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375255|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375256|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
375257|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375258|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375320|NCT00424645|P2|Participant Flow|Placebo|Placebo administered IV following Voraxaze arm.
375259|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375260|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375261|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375262|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375263|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375264|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
378420|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
375265|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375266|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375267|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
375268|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375269|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375270|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375271|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375272|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375273|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375274|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375275|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375276|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375277|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375278|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
375279|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375280|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375281|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375282|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375283|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375284|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375285|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375286|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375287|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375288|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375289|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
375290|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375291|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375292|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375409|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375293|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375294|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375295|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375296|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375297|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375298|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375299|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375300|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375301|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375302|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375303|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375304|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375305|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375306|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375307|NCT00424632|E10|Reported Event|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375308|NCT00424632|E9|Reported Event|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375309|NCT00424632|E8|Reported Event|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
375310|NCT00424632|E7|Reported Event|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375311|NCT00424632|E6|Reported Event|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375312|NCT00424632|E5|Reported Event|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375313|NCT00424632|E4|Reported Event|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375314|NCT00424632|E3|Reported Event|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375315|NCT00424632|E2|Reported Event|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375316|NCT00424632|E1|Reported Event|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
375321|NCT00424645|P1|Participant Flow|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
375322|NCT00424645|O2|Outcome|Placebo|Placebo administered IV following Voraxaze arm.
375323|NCT00424645|O1|Outcome|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
375324|NCT00424645|E2|Reported Event|Placebo|Placebo administered IV following Voraxaze arm.
375325|NCT00424645|E1|Reported Event|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
375326|NCT00424749|B1|Baseline|Rituximab|375 mg/m^2/week for 4 weeks
375327|NCT00424749|P1|Participant Flow|Rituximab|375 mg/m^2/week for 4 weeks
375328|NCT00424749|O1|Outcome|Rituximab|The remission induction regimen included oral prednisone and rituximab. Prednisone was started at 1 mg/kg/day for 4 weeks followed by a taper to 0 mg by 6 months. Rituximab 375 mg/m2 intravenously, once a week for 4 weeks was given within 2 weeks of starting steroid therapy.
375506|NCT00425100|O2|Outcome|Open Label Week 12|
375507|NCT00425100|O1|Outcome|Open Label Baseline|
375329|NCT00424749|O1|Outcome|Rituximab|The remission induction regimen included oral prednisone and rituximab. Prednisone was started at 1 mg/kg/day for 4 weeks followed by a taper to 0 mg by 6 months. Rituximab 375 mg/m2 intravenously, once a week for 4 weeks was given within 2 weeks of starting steroid therapy.
375330|NCT00424749|E1|Reported Event|Rituximab|375 mg/m^2/week for 4 weeks
375331|NCT00424762|B3|Baseline|Total|Total of all reporting groups
375332|NCT00424762|B2|Baseline|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
375333|NCT00424762|B1|Baseline|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
375334|NCT00424762|P2|Participant Flow|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
375335|NCT00424762|P1|Participant Flow|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
375336|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
375337|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
375338|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
375339|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
375340|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
375341|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
375342|NCT00424762|E2|Reported Event|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
375343|NCT00424762|E1|Reported Event|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
375344|NCT00424775|B1|Baseline|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
375345|NCT00424775|P2|Participant Flow|Vorinostat (400 mg)|This group includes data from all participants who are treated with vorinostat 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle. However, no participants received vorinostat 400 mg once daily due to early discontinuation of the study based on the dose limited toxicity on vorinostat 300 mg once daily.
375346|NCT00424775|P1|Participant Flow|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.
375347|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
375348|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
375349|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
375350|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
375351|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
375352|NCT00424775|E1|Reported Event|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
375353|NCT00424827|B1|Baseline|This Was a Prospective, Single Arm, Open Label Pilot Phase II|"A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil, and Radiation Therapy in Locally Advanced Nonmetastatic Pancreatic Adenocarcinoma
This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
Locally advanced pancreatic cancer is defined as surgically unresectable, but has no evidence of distant metastases. The purpose of this study is to evaluate the efficacy and safety of cetuximab in combination with gemcitabine and 5-FU along with radiation therapy in locally advanced non-resectable, pancreatic adenocarcinoma, using progression free survival as the primary end point."
375396|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375397|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375398|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375354|NCT00424827|P1|Participant Flow|Single Arm|"This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
Gemcitabine/Fluorouracil with External Beam Radiation: This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma."
375355|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
375356|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
375357|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
375358|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
375359|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|Progression-free survival
375360|NCT00424827|E1|Reported Event|Gemcitabine/Fluorouracil With External Beam Radiation|antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
375361|NCT00425061|B8|Baseline|Total|Total of all reporting groups
375362|NCT00425061|B7|Baseline|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375363|NCT00425061|B6|Baseline|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375364|NCT00425061|B5|Baseline|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375365|NCT00425061|B4|Baseline|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375366|NCT00425061|B3|Baseline|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375367|NCT00425061|B2|Baseline|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375368|NCT00425061|B1|Baseline|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375369|NCT00425061|P7|Participant Flow|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375370|NCT00425061|P6|Participant Flow|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375371|NCT00425061|P5|Participant Flow|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375372|NCT00425061|P4|Participant Flow|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375373|NCT00425061|P3|Participant Flow|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375374|NCT00425061|P2|Participant Flow|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375375|NCT00425061|P1|Participant Flow|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375376|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375377|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375378|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375379|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375380|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375381|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375382|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375383|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375384|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375385|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375386|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375387|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375388|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375389|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375390|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375391|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375392|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375393|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375394|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375395|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375399|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375400|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375401|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375402|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375403|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375404|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375405|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375406|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375410|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375411|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375412|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375413|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375414|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375415|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375416|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375417|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375418|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375419|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375420|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375421|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375422|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375423|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375424|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375425|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375426|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375427|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375428|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375429|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375430|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375431|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375432|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375433|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375434|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375435|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375436|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375437|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375438|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375439|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375440|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375441|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375442|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375443|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
376300|NCT00417417|O1|Outcome|Rilonacept|rilonacept 320 mg x 4 administrations over 8 weeks.
375444|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375445|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375446|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375447|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375448|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375449|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375450|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375451|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375452|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375453|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375508|NCT00425100|O1|Outcome|Open Label Week 12|
375509|NCT00425100|O2|Outcome|Open Label Week 12|
375454|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375455|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375456|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375457|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375458|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375459|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375460|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375461|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375462|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375463|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375464|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375465|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375466|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375467|NCT00425061|O2|Outcome|Placebo|Included all participants who received placebo matched to IMA-638 subcutaneous injection during Stage 1, 2 or 3.
375468|NCT00425061|O1|Outcome|IMA-638|Included participants who received any dose of IMA-638 subcutaneous injection during Stage 1, 2 or 3.
375469|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375470|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375471|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375472|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375473|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375474|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375475|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375476|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375477|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375478|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375479|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375480|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375481|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375482|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375483|NCT00425061|E7|Reported Event|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375484|NCT00425061|E6|Reported Event|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
375485|NCT00425061|E5|Reported Event|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
375486|NCT00425061|E4|Reported Event|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375487|NCT00425061|E3|Reported Event|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375488|NCT00425061|E2|Reported Event|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
385514|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
375489|NCT00425061|E1|Reported Event|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
375490|NCT00425100|B1|Baseline|Open Label-fesoterodine|All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
375491|NCT00425100|P1|Participant Flow|Open Label-fesoterodine|All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
375492|NCT00425100|O1|Outcome|Open Label Week 12|
375493|NCT00425100|O2|Outcome|Open Label Week 12|
375494|NCT00425100|O1|Outcome|Open Label Baseline|
375495|NCT00425100|O1|Outcome|Open Label Week 12|
375496|NCT00425100|O2|Outcome|Open Label Week 12|
375497|NCT00425100|O1|Outcome|Open Label Baseline|
375498|NCT00425100|O2|Outcome|Open Label Week 12|
375499|NCT00425100|O1|Outcome|Open Label Baseline|
375500|NCT00425100|O2|Outcome|Open Label Week 12|
375501|NCT00425100|O1|Outcome|Open Label Baseline|
375502|NCT00425100|O2|Outcome|Open Label Week 12|
375503|NCT00425100|O1|Outcome|Open Label Baseline|
375504|NCT00425100|O2|Outcome|Open Label Week 12|
375505|NCT00425100|O1|Outcome|Open Label Baseline|
375529|NCT00425113|B1|Baseline|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
375530|NCT00425113|P2|Participant Flow|Placebo|
375531|NCT00425113|P1|Participant Flow|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
375532|NCT00425113|O2|Outcome|Placebo|
375533|NCT00425113|O1|Outcome|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
375534|NCT00425113|O2|Outcome|Placebo|
375535|NCT00425113|O1|Outcome|Metronidazole|Subjects were randomized to receive metronidazole 500 mg three times daily or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
375536|NCT00425113|E2|Reported Event|Placebo|
375537|NCT00425113|E1|Reported Event|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
375538|NCT00425269|B3|Baseline|Total|Total of all reporting groups
375539|NCT00425269|B2|Baseline|Control|Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
375540|NCT00425269|B1|Baseline|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375541|NCT00425269|P2|Participant Flow|Control|Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
375542|NCT00425269|P1|Participant Flow|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375543|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375561|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375579|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
376301|NCT00417417|E2|Reported Event|Placebo|placebo injected every two weeks for two months
375544|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375545|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375546|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375547|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375548|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375549|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375550|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
393888|NCT00471068|O1|Outcome|Travatan|
375551|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375552|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375553|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375554|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375555|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375556|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375557|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375558|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375559|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375560|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375562|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375563|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375564|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375565|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375566|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375567|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375568|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375569|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375570|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375571|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375572|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375573|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375574|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375575|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375576|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375577|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375578|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375580|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375581|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375582|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375583|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375584|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375585|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375586|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375587|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375588|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375589|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375590|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375591|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375592|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375593|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375594|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375595|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375596|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375597|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375598|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375599|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375600|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375601|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375602|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375603|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375621|NCT00425308|P1|Participant Flow|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
378421|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
375604|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375605|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375606|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375607|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375608|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375609|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375610|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375611|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375612|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375613|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375635|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
376302|NCT00417417|E1|Reported Event|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
375614|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375615|NCT00425269|E2|Reported Event|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
375616|NCT00425269|E1|Reported Event|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.
The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
375617|NCT00425308|B3|Baseline|Total|Total of all reporting groups
375618|NCT00425308|B2|Baseline|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375619|NCT00425308|B1|Baseline|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375620|NCT00425308|P2|Participant Flow|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
378422|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
375622|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375623|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375624|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375625|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375626|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375627|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375628|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375629|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375630|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375631|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375632|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375633|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375634|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375671|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375636|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375637|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375638|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375639|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375640|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375641|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375642|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375643|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375644|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375645|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375646|NCT00425308|E2|Reported Event|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
375647|NCT00425308|E1|Reported Event|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
375648|NCT00425373|B10|Baseline|Total|Total of all reporting groups
375649|NCT00425373|B9|Baseline|Placebo|4 tablet and 2 capsule placebos taken once daily
375650|NCT00425373|B8|Baseline|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375651|NCT00425373|B7|Baseline|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375652|NCT00425373|B6|Baseline|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375653|NCT00425373|B5|Baseline|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375654|NCT00425373|B4|Baseline|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375655|NCT00425373|B3|Baseline|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375656|NCT00425373|B2|Baseline|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375657|NCT00425373|B1|Baseline|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375658|NCT00425373|P9|Participant Flow|Placebo|4 tablet and 2 capsule placebos taken once daily
375659|NCT00425373|P8|Participant Flow|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375660|NCT00425373|P7|Participant Flow|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375661|NCT00425373|P6|Participant Flow|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375662|NCT00425373|P5|Participant Flow|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375663|NCT00425373|P4|Participant Flow|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375664|NCT00425373|P3|Participant Flow|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375665|NCT00425373|P2|Participant Flow|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375666|NCT00425373|P1|Participant Flow|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375667|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
375668|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375669|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375670|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375672|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375673|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375674|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375675|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375676|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
375677|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375678|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375679|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375680|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375681|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375682|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375683|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375684|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375685|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
375686|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375687|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375688|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375689|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375690|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375691|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375692|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375693|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375694|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
375695|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375696|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375697|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375698|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375699|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375700|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375701|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375702|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375703|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
375704|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375705|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375706|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375707|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375708|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375709|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375710|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375711|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375712|NCT00425373|E9|Reported Event|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375713|NCT00425373|E8|Reported Event|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375714|NCT00425373|E7|Reported Event|Amlodipine 5 mg|Amlodipine 2.5 mg 2 capsules plus 4 tablet placebos taken once daily
375715|NCT00425373|E6|Reported Event|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375716|NCT00425373|E5|Reported Event|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375717|NCT00425373|E4|Reported Event|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
375718|NCT00425373|E3|Reported Event|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375719|NCT00425373|E2|Reported Event|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
375720|NCT00425373|E1|Reported Event|Placebo|4 tablet and 2 capsule placebos taken once daily
375721|NCT00425386|B1|Baseline|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
150 mg/day, continuous daily
Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
375722|NCT00425386|P1|Participant Flow|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
150 mg/day, continuous daily
Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
375723|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
150 mg/day, continuous daily
Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
375724|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
150 mg/day, continuous daily
Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
375725|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
150 mg/day, continuous daily
Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
375726|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
150 mg/day, continuous daily
Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
375727|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
150 mg/day, continuous daily
Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
375728|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
150 mg/day, continuous daily
Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
375729|NCT00425386|E1|Reported Event|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
150 mg/day, continuous daily
Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
375730|NCT00425438|B3|Baseline|Total|Total of all reporting groups
375783|NCT00425854|B1|Baseline|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
393889|NCT00471068|E2|Reported Event|Cosopt|
375731|NCT00425438|B2|Baseline|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375732|NCT00425438|B1|Baseline|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375733|NCT00425438|P2|Participant Flow|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 grams per square meter (g/m^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (/mm^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375734|NCT00425438|P1|Participant Flow|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375735|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375736|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375748|NCT00425438|E1|Reported Event|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375737|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375738|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375739|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375740|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
376111|NCT00416520|E1|Reported Event|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated
375741|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375742|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375743|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375744|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375745|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375746|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375747|NCT00425438|E2|Reported Event|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
375766|NCT00425698|B3|Baseline|Total|Total of all reporting groups
375749|NCT00425503|B1|Baseline|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
375750|NCT00425503|P1|Participant Flow|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
375751|NCT00425503|O1|Outcome|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
375752|NCT00425503|E1|Reported Event|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
375753|NCT00425607|B1|Baseline|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 fo patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo.
375754|NCT00425607|P1|Participant Flow|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 for patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo.
375755|NCT00425607|O1|Outcome|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 for patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo.
376112|NCT00416572|B4|Baseline|Total|Total of all reporting groups
375756|NCT00425607|E1|Reported Event|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 fo patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo. Patients were monitored for liver, kidney, and hematological toxicity each month for the first 3 mo by their local physicians and every 4 mo in Boston for the duration of the study. Adverse events were monitored and recorded throughout the study.
375757|NCT00425672|B1|Baseline|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ONTAK: Given IV
flow cytometry: Correlative studies
immunohistochemistry staining method: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
laboratory biomarker analysis: Correlative studies
protein expression analysis: Correlative studies"
375758|NCT00425672|P1|Participant Flow|ONTAK|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ONTAK: Given IV
flow cytometry: Correlative studies
immunohistochemistry staining method: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
laboratory biomarker analysis: Correlative studies
protein expression analysis: Correlative studies"
375759|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ONTAK: Given IV
flow cytometry: Correlative studies
immunohistochemistry staining method: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
laboratory biomarker analysis: Correlative studies
protein expression analysis: Correlative studies"
375760|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ONTAK: Given IV
flow cytometry: Correlative studies
immunohistochemistry staining method: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
laboratory biomarker analysis: Correlative studies
protein expression analysis: Correlative studies"
375761|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ONTAK: Given IV
flow cytometry: Correlative studies
immunohistochemistry staining method: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
laboratory biomarker analysis: Correlative studies
protein expression analysis: Correlative studies"
375762|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ONTAK: Given IV
flow cytometry: Correlative studies
immunohistochemistry staining method: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
laboratory biomarker analysis: Correlative studies
protein expression analysis: Correlative studies"
375763|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ONTAK: Given IV
flow cytometry: Correlative studies
immunohistochemistry staining method: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
laboratory biomarker analysis: Correlative studies
protein expression analysis: Correlative studies"
375764|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ONTAK: Given IV
flow cytometry: Correlative studies
immunohistochemistry staining method: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
laboratory biomarker analysis: Correlative studies
protein expression analysis: Correlative studies"
375765|NCT00425672|E1|Reported Event|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ONTAK: Given IV
flow cytometry: Correlative studies
immunohistochemistry staining method: Correlative studies
enzyme-linked immunosorbent assay: Correlative studies
laboratory biomarker analysis: Correlative studies
protein expression analysis: Correlative studies"
375775|NCT00425750|B1|Baseline|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
375776|NCT00425750|P1|Participant Flow|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
375777|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
375778|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
375779|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
375780|NCT00425750|E1|Reported Event|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
375781|NCT00425854|B3|Baseline|Total|Total of all reporting groups
375782|NCT00425854|B2|Baseline|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
376113|NCT00416572|B3|Baseline|Control Condition|Participants received care as usual.
375784|NCT00425854|P2|Participant Flow|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
375785|NCT00425854|P1|Participant Flow|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
375786|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
375787|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
375788|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
375789|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
375790|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
375791|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
375792|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
375793|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
375794|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
375795|NCT00425854|O1|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
375796|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
375797|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
375798|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
375799|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
375800|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
375801|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
375802|NCT00425854|O1|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
375803|NCT00425854|E2|Reported Event|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
375804|NCT00425854|E1|Reported Event|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
375805|NCT00425945|B3|Baseline|Total|Total of all reporting groups
375806|NCT00425945|B2|Baseline|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375807|NCT00425945|B1|Baseline|Pine Bark Extract|200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily. Pine Bark Extract (Flavangenol�) : Flavangenol 200 mg per day. Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks.
375808|NCT00425945|P2|Participant Flow|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375809|NCT00425945|P1|Participant Flow|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375810|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375811|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375812|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375813|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375814|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
376136|NCT00416624|B5|Baseline|Total|Total of all reporting groups
375815|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375816|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375817|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375818|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375819|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375820|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375821|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375822|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375823|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375824|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375825|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375826|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375827|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375828|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
376303|NCT00417482|B4|Baseline|Total|Total of all reporting groups
375829|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375830|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375831|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375832|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375833|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375834|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375835|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
378423|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
375836|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375837|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375838|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375839|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375840|NCT00425945|O2|Outcome|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375841|NCT00425945|O1|Outcome|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375842|NCT00425945|E2|Reported Event|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
375843|NCT00425945|E1|Reported Event|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.
Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
375844|NCT00426127|B1|Baseline|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg
Docetaxel
Liposomal Doxorubicin
Enoxaparin"
375845|NCT00426127|P1|Participant Flow|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg
Docetaxel
Liposomal Doxorubicin
Enoxaparin"
375846|NCT00426127|O1|Outcome|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg
Docetaxel
Liposomal Doxorubicin
Enoxaparin"
375847|NCT00426127|O1|Outcome|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg
Docetaxel
Liposomal Doxorubicin
Enoxaparin"
375848|NCT00426127|O1|Outcome|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg
Docetaxel
Liposomal Doxorubicin
Enoxaparin"
375849|NCT00426127|E1|Reported Event|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg
Docetaxel
Liposomal Doxorubicin
Enoxaparin"
375850|NCT00426153|B3|Baseline|Total|Total of all reporting groups
375851|NCT00426153|B2|Baseline|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
375852|NCT00426153|B1|Baseline|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
375853|NCT00426153|P2|Participant Flow|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
375854|NCT00426153|P1|Participant Flow|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
375855|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
385515|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
375856|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
375857|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
375858|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
375859|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
375860|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
375861|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
375862|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
375863|NCT00426153|E2|Reported Event|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
375864|NCT00426153|E1|Reported Event|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
375865|NCT00426231|B3|Baseline|Total|Total of all reporting groups
375866|NCT00426231|B2|Baseline|Information Control|"Information control
Information control : Information about medication access programs provided to the participant and their healthcare provider"
375867|NCT00426231|B1|Baseline|Patient Navigator Intervention|"Patient Navigator intervention
Navigation by a health worker : Help provided by health worker to navigate medication access programs"
375868|NCT00426231|P2|Participant Flow|Information Control|"Information control
Information control : Information about medication access programs provided to the participant and their healthcare provider"
375869|NCT00426231|P1|Participant Flow|Patient Navigator Intervention|"Patient Navigator intervention
Navigation by a health worker : Help provided by health worker to navigate medication access programs"
375870|NCT00426231|O2|Outcome|Information Control|"Information control
Information control : Information about medication access programs provided to the participant and their healthcare provider"
375871|NCT00426231|O1|Outcome|Patient Navigator Intervention|"Patient Navigator intervention
Navigation by a health worker : Help provided by health worker to navigate medication access programs"
375872|NCT00426231|O2|Outcome|Information Control|"Information control
Information control : Information about medication access programs provided to the participant and their healthcare provider"
375873|NCT00426231|O1|Outcome|Patient Navigator Intervention|"Patient Navigator intervention
Navigation by a health worker : Help provided by health worker to navigate medication access programs"
375874|NCT00426231|E2|Reported Event|Information Control|"Information control
Information control : Information about medication access programs provided to the participant and their healthcare provider"
375875|NCT00426231|E1|Reported Event|Patient Navigator Intervention|"Patient Navigator intervention
Navigation by a health worker : Help provided by health worker to navigate medication access programs"
375876|NCT00426270|B1|Baseline|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
375877|NCT00426270|P1|Participant Flow|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
375878|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
375879|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
375880|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
375881|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
375882|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
375883|NCT00426270|E1|Reported Event|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
375884|NCT00426283|B3|Baseline|Total|Total of all reporting groups
375885|NCT00426283|B2|Baseline|Placebo 1760 mcg|Placebo : 1760 mcg daily
375886|NCT00426283|B1|Baseline|Flovent 1760 mcg|"Drug
Flovent : 1760 mcg daily"
375887|NCT00426283|P2|Participant Flow|Placebo 1760 mcg|Placebo : 1760 mcg daily
375888|NCT00426283|P1|Participant Flow|Flovent 1760 mcg|"Drug
Flovent : 1760 mcg daily"
375889|NCT00426283|O2|Outcome|Placebo 1760 mcg|Placebo : 1760 mcg daily
375890|NCT00426283|O1|Outcome|Flovent 1760 mcg|"Drug
Flovent : 1760 mcg daily"
375891|NCT00426283|E2|Reported Event|Placebo 1760 mcg|Placebo : 1760 mcg daily
375892|NCT00426283|E1|Reported Event|Flovent 1760 mcg|"Drug
Flovent : 1760 mcg daily"
375893|NCT00426361|B4|Baseline|Total|Total of all reporting groups
375894|NCT00426361|B3|Baseline|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375895|NCT00426361|B2|Baseline|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375896|NCT00426361|B1|Baseline|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375897|NCT00426361|P3|Participant Flow|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375898|NCT00426361|P2|Participant Flow|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375899|NCT00426361|P1|Participant Flow|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
376166|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
375900|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375901|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375902|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375903|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375904|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375905|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375906|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375907|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375908|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375909|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375910|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375911|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
378424|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
375912|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375913|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375914|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375915|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375916|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375917|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375918|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375919|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375920|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375921|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375922|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375923|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375924|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375925|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375926|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375927|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375928|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375929|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375930|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375931|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375932|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375933|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375934|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375935|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375936|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
376167|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
375937|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375938|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375939|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375940|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375941|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375942|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375943|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375944|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375945|NCT00426361|E3|Reported Event|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
375946|NCT00426361|E2|Reported Event|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
375947|NCT00426361|E1|Reported Event|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
375948|NCT00426556|B5|Baseline|Total|Total of all reporting groups
378425|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
375949|NCT00426556|B4|Baseline|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375950|NCT00426556|B3|Baseline|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
375951|NCT00426556|B2|Baseline|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375952|NCT00426556|B1|Baseline|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375953|NCT00426556|P4|Participant Flow|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375954|NCT00426556|P3|Participant Flow|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
375955|NCT00426556|P2|Participant Flow|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375956|NCT00426556|P1|Participant Flow|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375957|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375958|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
375959|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375960|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375961|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375962|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
375963|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375964|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375965|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375966|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
375967|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375968|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375969|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375970|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
375971|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375972|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375973|NCT00426556|E4|Reported Event|Phase II - Everolimus 10mg Daily + PT|Phase II - Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375974|NCT00426556|E3|Reported Event|Phase I - Everolimus 30mg Weekly + PT|Phase I - Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375975|NCT00426556|E2|Reported Event|Phase I - Everolimus 10mg Daily + PT|Phase I - Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375976|NCT00426556|E1|Reported Event|Phase I - Everolimus 5mg Daily + PT|Phase I - Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
375977|NCT00426660|B1|Baseline|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375978|NCT00426660|P1|Participant Flow|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375979|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375980|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375981|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375982|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375983|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375984|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
393890|NCT00471068|E1|Reported Event|Travatan|
375985|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375986|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375987|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375988|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375989|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375990|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375991|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375992|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375993|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375994|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375995|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375996|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375997|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375998|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
375999|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
376000|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
376001|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
376002|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
376003|NCT00426660|E1|Reported Event|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
376005|NCT00426751|B2|Baseline|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376006|NCT00426751|B1|Baseline|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376007|NCT00426751|P2|Participant Flow|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376008|NCT00426751|P1|Participant Flow|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376009|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376010|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376011|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376012|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376013|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376014|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376015|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376016|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376017|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376018|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376019|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376020|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376021|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376022|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376023|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376024|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376025|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376026|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376027|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376028|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376029|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376030|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376031|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376168|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376032|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376033|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376034|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376035|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376036|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376037|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376038|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376039|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376040|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376041|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376042|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376043|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376044|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376045|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376046|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376047|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376048|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376049|NCT00426751|E2|Reported Event|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
376050|NCT00426751|E1|Reported Event|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
376051|NCT00426764|B1|Baseline|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376052|NCT00426764|P1|Participant Flow|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376053|NCT00426764|O6|Outcome|Best ECOG = 4|Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376054|NCT00426764|O5|Outcome|Best ECOG = 3|Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376259|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376055|NCT00426764|O4|Outcome|Best ECOG = 2|Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376056|NCT00426764|O3|Outcome|Best ECOG = 1|Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376057|NCT00426764|O2|Outcome|Best ECOG = 0|Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376058|NCT00426764|O1|Outcome|Missing|Participants with a missing best on study ECOG performance score, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376059|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376060|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376061|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376062|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376063|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376064|NCT00426764|E1|Reported Event|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
376065|NCT00416455|B3|Baseline|Total|Total of all reporting groups
376066|NCT00416455|B2|Baseline|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376067|NCT00416455|B1|Baseline|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376068|NCT00416455|P2|Participant Flow|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376069|NCT00416455|P1|Participant Flow|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376070|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376071|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376072|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376073|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376074|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376075|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376076|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376077|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376078|NCT00416455|E2|Reported Event|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376079|NCT00416455|E1|Reported Event|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
376080|NCT00416494|B3|Baseline|Total|Total of all reporting groups
376081|NCT00416494|B2|Baseline|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
376082|NCT00416494|B1|Baseline|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
376083|NCT00416494|P2|Participant Flow|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
376084|NCT00416494|P1|Participant Flow|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
376085|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
376086|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
376087|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
376088|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
376089|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
376090|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
376091|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
376092|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
376093|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
376094|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
376095|NCT00416494|E2|Reported Event|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
376096|NCT00416494|E1|Reported Event|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
376097|NCT00416520|B3|Baseline|Total|Total of all reporting groups
376098|NCT00416520|B2|Baseline|Sevelamer (Open-label Period)|
376099|NCT00416520|B1|Baseline|MCI-196 (Open-label Period)|
376100|NCT00416520|P4|Participant Flow|Placebo (Placebo-controlled Withdrawal Period)|"dose level at the end of dose titration in the flexible dose period
There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants One subject did not take any study medication and excluded from Baseline Participants."
376101|NCT00416520|P3|Participant Flow|MCI-196 (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
376127|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
376128|NCT00416572|E3|Reported Event|Control Condition|Participants received care as usual.
376102|NCT00416520|P2|Participant Flow|Sevelamer (Open-label Period)|"2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
There was a gap of 2 subjects between STARTED and Overall Number of Baseline Participants.
Three subjects in Sevelamer group were randomised in error and did not take any study medication. These 3 subjects were excluded from Baseline Participants of Sevelamer group.
However, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for STARTED but counted as Sevelamer group for Baseline Participants."
376103|NCT00416520|P1|Participant Flow|MCI-196 (Open-label Period)|"3, 6, 9, 12, or 15g/day as titrated
There was a gap of 3 subjects between STARTED and Overall Number of Baseline Participants.
Two subjects were randomised to receive MCI-196, but did not take study medication. These 2 subjects were excluded from Baseline Participants of MCI-196 group.
In addition, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for STARTED but counted as Sevelamer group for Baseline Participants."
376104|NCT00416520|O2|Outcome|Sevelamer (Open-label Period)|2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
376105|NCT00416520|O1|Outcome|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated
376106|NCT00416520|O2|Outcome|Placebo (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
376107|NCT00416520|O1|Outcome|MCI-196 (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
376108|NCT00416520|E4|Reported Event|Placebo (Placebo-Controlled Period)|dose level at the end of dose titration in the flexible dose period
376109|NCT00416520|E3|Reported Event|MCI-196 (Placebo-Controlled Period)|dose level at the end of dose titration in the flexible dose period
376110|NCT00416520|E2|Reported Event|Sevelamer (Open-label Period)|2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
376114|NCT00416572|B2|Baseline|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
376115|NCT00416572|B1|Baseline|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
376116|NCT00416572|P3|Participant Flow|Control Condition|Participants received care as usual.
376117|NCT00416572|P2|Participant Flow|Nutrition Education Intervention|"Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it."
376118|NCT00416572|P1|Participant Flow|Education Intervention|"Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read."
376119|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
376120|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
376121|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
376122|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
376123|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
376124|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
376125|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
376126|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
376165|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
385516|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
376129|NCT00416572|E2|Reported Event|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
376130|NCT00416572|E1|Reported Event|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
376131|NCT00416598|B1|Baseline|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
376132|NCT00416598|P1|Participant Flow|Treatment (Chemotherapy, PBSC or Bone Marrow Transplantation)|"See Detailed Description:
Patients undergo induction therapy comprising cytarabine and daunorubicin hydrochloride. Patient with RD undergo second induction therapy comprising cytarabine, daunorubicin hydrochloride, and etoposide. Patients with CR and favorable cytogenetics who achieve CR receive intensification therapy comprising high-dose cytarabine. Patients with UC receive etoposide, high-dose cytarabine, G-CSF., and busulfan and proceed to PBSC or bone marrow transplantation. Patients with UC and unable to undergo transplantation receive etoposide, high-dose cytarabine, and G-CSF. Patients then receive decitabine as maintenance therapy."
376133|NCT00416598|O1|Outcome|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
376134|NCT00416598|O1|Outcome|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
376135|NCT00416598|E1|Reported Event|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
376137|NCT00416624|B4|Baseline|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376138|NCT00416624|B3|Baseline|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376139|NCT00416624|B2|Baseline|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376140|NCT00416624|B1|Baseline|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376141|NCT00416624|P4|Participant Flow|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376142|NCT00416624|P3|Participant Flow|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376143|NCT00416624|P2|Participant Flow|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376144|NCT00416624|P1|Participant Flow|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376145|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376146|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376147|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376148|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376149|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376150|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376151|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376152|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376153|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376154|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376155|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376156|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376157|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376158|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376159|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376160|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376161|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376162|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376163|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376164|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
385517|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
376169|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376170|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376171|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376172|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376173|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376174|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376175|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376176|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376177|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376178|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376179|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376180|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376181|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376182|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376183|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376184|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376185|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376186|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376187|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376188|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376189|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376190|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376191|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376192|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376193|NCT00416624|E4|Reported Event|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
376194|NCT00416624|E3|Reported Event|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376195|NCT00416624|E2|Reported Event|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
376196|NCT00416624|E1|Reported Event|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
376197|NCT00416715|B1|Baseline|Treatment (Letrozole)|"Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
letrozole: Given PO
calcium carbonate: Given PO
laboratory biomarker analysis: Optional correlative studies
calcium citrate: Given PO
calcium glucarate: Given PO
calcium gluconate: Given PO
cholecalciferol: Given PO
assessment of therapy complications: Ancillary studies
musculoskeletal complications management/prevention: Correlative studies"
376198|NCT00416715|P1|Participant Flow|Treatment (Letrozole)|"Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
letrozole: Given PO
calcium carbonate: Given PO
laboratory biomarker analysis: Optional correlative studies
calcium citrate: Given PO
calcium glucarate: Given PO
calcium gluconate: Given PO
cholecalciferol: Given PO
assessment of therapy complications: Ancillary studies
musculoskeletal complications management/prevention: Correlative studies"
376199|NCT00416715|O2|Outcome|Post Vitamin D Repletion (1 Month)|Those receiving Letrezole + vitamin D3
376200|NCT00416715|O1|Outcome|Baseline|Those receiving Letrozole + vitamin D3
376201|NCT00416715|O2|Outcome|Post Vitamin D Repletion (1 Month)|Patients with vitamin D deficiency who experience myalgias, arthralgias and/or joint stiffness.
376202|NCT00416715|O1|Outcome|Baseline|All patients that are evaluable for joint aches and vitamin D levels.
376203|NCT00416715|E1|Reported Event|Treatment (Letrezole)|"Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
letrozole: Given PO
calcium carbonate: Given PO
laboratory biomarker analysis: Optional correlative studies
calcium citrate: Given PO
calcium glucarate: Given PO
calcium gluconate: Given PO
cholecalciferol: Given PO
assessment of therapy complications: Ancillary studies
musculoskeletal complications management/prevention: Correlative studies"
376204|NCT00416793|B1|Baseline|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
376205|NCT00416793|P1|Participant Flow|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
376206|NCT00416793|O1|Outcome|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
376207|NCT00416793|E1|Reported Event|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
376208|NCT00416884|B1|Baseline|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
376209|NCT00416884|P1|Participant Flow|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
376210|NCT00416884|O1|Outcome|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
376211|NCT00416884|E1|Reported Event|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
376212|NCT00417027|B4|Baseline|Total|Total of all reporting groups
376213|NCT00417027|B3|Baseline|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
378426|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
376214|NCT00417027|B2|Baseline|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376215|NCT00417027|B1|Baseline|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
376216|NCT00417027|P3|Participant Flow|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376217|NCT00417027|P2|Participant Flow|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376218|NCT00417027|P1|Participant Flow|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
376219|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376220|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376221|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
376222|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376223|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376224|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
376225|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376226|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376227|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
376228|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376229|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376230|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
376231|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376232|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376233|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
376234|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376235|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376236|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
376237|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376238|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376239|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
376240|NCT00417027|E3|Reported Event|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376241|NCT00417027|E2|Reported Event|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
376242|NCT00417027|E1|Reported Event|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
376243|NCT00417079|B3|Baseline|Total|Total of all reporting groups
376244|NCT00417079|B2|Baseline|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376245|NCT00417079|B1|Baseline|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376246|NCT00417079|P2|Participant Flow|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376247|NCT00417079|P1|Participant Flow|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376248|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376249|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376250|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376251|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376252|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376253|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376254|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376255|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376256|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376257|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376258|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376260|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376261|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376262|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376263|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376264|NCT00417079|E2|Reported Event|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376265|NCT00417079|E1|Reported Event|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
376266|NCT00417170|B3|Baseline|Total|Total of all reporting groups
376267|NCT00417170|B2|Baseline|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
376268|NCT00417170|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
376269|NCT00417170|P2|Participant Flow|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
376270|NCT00417170|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
376271|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
376272|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
376273|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
376274|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
376275|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
393891|NCT00471107|B4|Baseline|Total|Total of all reporting groups
376276|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
376277|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
376278|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
376279|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
376280|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
376281|NCT00417170|E2|Reported Event|Amlodipine 5mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
376282|NCT00417170|E1|Reported Event|Aliskiren 300mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
376283|NCT00417248|B1|Baseline|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
376284|NCT00417248|P1|Participant Flow|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
376285|NCT00417248|O1|Outcome|Investigational Treatment|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
376286|NCT00417248|O1|Outcome|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
376287|NCT00417248|E1|Reported Event|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
376288|NCT00417274|B1|Baseline|Quinacrine Treatment|Uncontrolled treatment arm
376289|NCT00417274|P1|Participant Flow|Quinacrine Treatment|100 mg once a day
376290|NCT00417274|O1|Outcome|Quinacrine Treatment|100 mg once a day
376291|NCT00417274|E1|Reported Event|Quinacrine Treatment|Uncontrolled treatment arm
376292|NCT00417417|B3|Baseline|Total|Total of all reporting groups
376293|NCT00417417|B2|Baseline|Placebo|placebo injected every two weeks for two months
376294|NCT00417417|B1|Baseline|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
376295|NCT00417417|P2|Participant Flow|Placebo|placebo injected every two weeks x 4 administrations
376296|NCT00417417|P1|Participant Flow|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
376304|NCT00417482|B3|Baseline|Phase B Arm 3: Placebo-Placebo|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
376305|NCT00417482|B2|Baseline|Phase B Arm 2: Risperidone -Placebo|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
376306|NCT00417482|B1|Baseline|Phase B Arm 1: Risperidone-Risperidone|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
376337|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
396445|NCT00467753|B3|Baseline|Total|Total of all reporting groups
376307|NCT00417482|P3|Participant Flow|Phase B Arm 3: Placebo-Placebo|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).
Phase B Arm 3: Patients were randomized to placebo for 32 weeks."
376308|NCT00417482|P2|Participant Flow|Phase B Arm 2: Risperidone-Placebo|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).
Phase B Arm 2: Risperidone for 16 weeks followed by placebo for 16 weeks;"
376309|NCT00417482|P1|Participant Flow|Arm 1: Risperidone-Risperidone|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).
Phase B Arm 1: Risperidone for 16 weeks followed by risperidone for 16 weeks; Risperidone open label flexible dose was administered at a dose of 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for the randomized trial"
376310|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
376311|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
376312|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
376313|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
376314|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
376315|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
376316|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
376317|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
376318|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
376319|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
376320|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
376321|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
376322|NCT00417482|O2|Outcome|Arm 2: Risperidone - Placebo|Subjects in Arm 2 who did not relapse or terminate from the study in the first 16 weeks of Phase B received placebo in the second 16 weeks of Phase B.
376323|NCT00417482|O1|Outcome|Arm 1: Risperidone - Risperidone|Subjects in Arm 1 who did not relapse or terminate from the study in the first 16 weeks of Phase B continued to receive risperidone in the second 16 weeks of Phase B.
376324|NCT00417482|O3|Outcome|Phase B Arm 3: Placebo-Placebo|"40 patients randomized to Phase B Arm 3 received placebo for 32 weeks. For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C."
376325|NCT00417482|O2|Outcome|Phase B Arm 2: Risperidone -Placebo|"38 patients randomized to Phase B Arm 2 received risperidone therapy for 16 weeks followed by placebo for 16 weeks.
In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C."
376326|NCT00417482|O1|Outcome|Phase B Arm 1: Risperidone-Risperidone|32 patients randomized to Phase B Arm 1 received continuation risperidone for another 32 weeks.
376327|NCT00417482|E5|Reported Event|Wek 17-32 Phase B Arm 3: Placebo -Placebo|13 patients completed Week 0-16 of Phase B Arm 3 and entered Week 17-32 were they were given placebo for another 16 weeks.
376328|NCT00417482|E4|Reported Event|Wk 17-32 Phase B Arm 2: Risperdone-Placebo|27 patients completed Wk 0-16 of Phase B Arm 2 and entered Week 17-32 of Phase B Arm 2 where they receive placebo for 16 weeks.
376329|NCT00417482|E3|Reported Event|Wk 17-32 Phase B Arm 1: Risperdone-Risperdone|13 patients completed Wk 0-16 of Phase 2 Arm 1 and entered Wk 17-32 where they received risperidone for another 16 weeks.
376330|NCT00417482|E2|Reported Event|Wk 0-16 Phase B Arm 3: Placebo -Placebo|40 patients randomized to Phase B Arm 3 received placebo for 32 weeks.
376331|NCT00417482|E1|Reported Event|Wk0-16 Phase B Arm 1 (Risp-Risp) & Arm 2 (Risp-Pla)|32 patients randomized to Phase B Arm 1 received continuation risperidone for another 32 weeks; 38 patients randomized to Phase B Arm 2 received risperidone for 16 weeks followed by placebo for 16 weeks. Therefore there were a total of 70 patients in this group.
376332|NCT00417612|B3|Baseline|Total|Total of all reporting groups
376333|NCT00417612|B2|Baseline|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
376334|NCT00417612|B1|Baseline|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376335|NCT00417612|P2|Participant Flow|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
376336|NCT00417612|P1|Participant Flow|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce Parathyroid Hormone (PTH) level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376338|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376339|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
376340|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce parathyroid hormone (PTH) level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376341|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
376342|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376343|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
376344|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376345|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
376346|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376347|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
376348|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376349|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
376350|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376351|NCT00417612|O3|Outcome|Paricalcitol (Children Ages 9-17)|Pediatric patients ages 9-17 given paricalcitol
376352|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
376353|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376354|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
376355|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376356|NCT00417612|E2|Reported Event|Placebo|"Participants given placebo capsule to match for comparison
Placebo: Placebo sugar pill"
376357|NCT00417612|E1|Reported Event|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level
Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
376358|NCT00417885|B1|Baseline|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
376359|NCT00417885|P1|Participant Flow|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
376360|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
385518|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
376361|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
376362|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
376363|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
376364|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
376365|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
376366|NCT00417885|E1|Reported Event|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
376367|NCT00417963|B1|Baseline|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
376368|NCT00417963|P1|Participant Flow|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
376369|NCT00417963|O2|Outcome|6 Month Restenosis|Number of participants with restenosis at 6 months from implantation.
376370|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|placement of a bare metal stent for treatment of carotid artery stenosis
376371|NCT00417963|O1|Outcome|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
376372|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|placement of a bare metal stent for treatment of carotid artery stenosis
376373|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
376374|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
376375|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
376376|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
376377|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
376378|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
376379|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
376380|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
376381|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
376382|NCT00417963|O1|Outcome|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
376383|NCT00417963|E1|Reported Event|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
376384|NCT00417976|B1|Baseline|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.
Bevacizumab : 10 mg/kg every 2 weeks.
Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
376385|NCT00417976|P1|Participant Flow|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.
Bevacizumab : 10 mg/kg every 2 weeks.
Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
376386|NCT00417976|O1|Outcome|Bevacizumab|"Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.
Bevacizumab: 10 mg/kg every 2 weeks.
Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks."
376387|NCT00417976|O1|Outcome|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.
Bevacizumab : 10 mg/kg every 2 weeks.
Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
376388|NCT00417976|E1|Reported Event|Bevacizumab|"Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.
Bevacizumab: 10 mg/kg every 2 weeks.
Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks."
376389|NCT00417989|B3|Baseline|Total|Total of all reporting groups
376390|NCT00417989|B2|Baseline|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
376391|NCT00417989|B1|Baseline|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
376392|NCT00417989|P2|Participant Flow|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
376393|NCT00417989|P1|Participant Flow|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
376394|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
376395|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
376396|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
376397|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
376398|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
376399|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
376400|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
376401|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
376402|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
376403|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
376404|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
376405|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
376406|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
376407|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
376408|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
376409|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
376410|NCT00417989|E2|Reported Event|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
376411|NCT00417989|E1|Reported Event|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
376412|NCT00418015|B5|Baseline|Total|Total of all reporting groups
376413|NCT00418015|B4|Baseline|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
376414|NCT00418015|B3|Baseline|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
376415|NCT00418015|B2|Baseline|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
376416|NCT00418015|B1|Baseline|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
376417|NCT00418015|P4|Participant Flow|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
378427|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
376418|NCT00418015|P3|Participant Flow|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
376419|NCT00418015|P2|Participant Flow|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
376420|NCT00418015|P1|Participant Flow|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
376421|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
376422|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
376423|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
376424|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
376425|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
376426|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
376427|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
376428|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
376429|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
376430|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
376431|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
376432|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
376433|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
376434|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
376435|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
376436|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
376437|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
376438|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
376439|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
376440|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
376482|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|One additional subject left the study
376441|NCT00418015|E4|Reported Event|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
376442|NCT00418015|E3|Reported Event|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
376443|NCT00418015|E2|Reported Event|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
376444|NCT00418015|E1|Reported Event|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
376445|NCT00418093|B1|Baseline|Group 1|
376446|NCT00418093|P1|Participant Flow|Chemotherapy Group|Oxaliplatin plus Gemcitabine plus Bevacizumab
376447|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
376448|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
376449|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
376450|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
376451|NCT00418093|E1|Reported Event|Group 1|
376452|NCT00418145|B1|Baseline|Total Study Participants|Overall study participants - Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data.
376453|NCT00418145|P1|Participant Flow|Total Study Participants|Overall study participants. Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data.
376454|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days
IV methylprednisolone: 1000 mg/qd/5 days"
378428|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
376455|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days
megadose oral methylprednisolone: 1400 mg qd/5 days"
376456|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days
IV methylprednisolone: 1000 mg/qd/5 days"
376457|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days
megadose oral methylprednisolone: 1400 mg qd/5 days"
376458|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days
IV methylprednisolone: 1000 mg/qd/5 days"
376459|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days
megadose oral methylprednisolone: 1400 mg qd/5 days"
376460|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days
IV methylprednisolone: 1000 mg/qd/5 days"
376461|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days
megadose oral methylprednisolone: 1400 mg qd/5 days"
376462|NCT00418145|E2|Reported Event|IV Methylprednisolone|"1000 mg/qd/5 days
IV methylprednisolone: 1000 mg/qd/5 days"
376463|NCT00418145|E1|Reported Event|Megadose Oral Methylprednisolone|"1400 mg qd/5 days
megadose oral methylprednisolone: 1400 mg qd/5 days"
376464|NCT00418184|B3|Baseline|Total|Total of all reporting groups
376465|NCT00418184|B2|Baseline|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
376466|NCT00418184|B1|Baseline|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
376467|NCT00418184|P2|Participant Flow|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
376468|NCT00418184|P1|Participant Flow|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
376469|NCT00418184|O2|Outcome|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
376470|NCT00418184|O1|Outcome|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
376471|NCT00418184|O2|Outcome|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
376472|NCT00418184|O1|Outcome|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
376473|NCT00418184|E2|Reported Event|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
376474|NCT00418184|E1|Reported Event|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
376475|NCT00418262|B1|Baseline|Atomoxetine HCL (Strattera)|The subjects will receive atomoxetine at 0.5 mg/kg/day for the first week. The children will be seen weekly for assessment for 4 weeks, every month for two months, then every three months until the 12 month treatment period is complete. After one week of treatment response will be reassessed and the dose will be increased to 1.0 mg/kg/d unless there are excessive side effects. If there are mild side effects the dose will be held the same. If there are excessive side effects the dose will be split to 0.25 mg/kg-d BID. At visit 3 the dose will be increased to 1.0 or 1.4 mg/kg-d, depending on the previous dose, if there are not excessive side effects. This “titration” will occur at each visit.
376476|NCT00418262|P1|Participant Flow|Atomoxetine HCL (Strattera)|The subjects will receive atomoxetine at 0.5 mg/kg/day for the first week. The children will be seen weekly for assessment for 4 weeks, every month for two months, then every three months until the 12 month treatment period is complete. After one week of treatment response will be reassessed and the dose will be increased to 1.0 mg/kg/d unless there are excessive side effects. If there are mild side effects the dose will be held the same. If there are excessive side effects the dose will be split to 0.25 mg/kg-d BID. At visit 3 the dose will be increased to 1.0 or 1.4 mg/kg-d, depending on the previous dose, if there are not excessive side effects. This titration will occur at each visit.
376477|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|"Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
atomoxetine hydrochloride: Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food."
376478|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
376479|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
376480|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
376481|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
376483|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
376484|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|"Visit 1
One additional subject left the study"
376485|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
376486|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
376487|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|One additional subject left the study
376488|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|"Visit 1
One additional subject left the study"
376489|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
376490|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
376491|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
376492|NCT00418262|E1|Reported Event|Atomoxetine HCL (Strattera)|The subjects received 7 days of atomoxetine at 0.5 mg/kg/day. The children were seen weekly for assessment for 4 weeks then every two weeks until the eight week double blind period was completed. After each week of treatment, response was reassessed and the dose was increased to 1.0 then 1.4 mg/kg/d unless there were excessive side effects. The subjects were then invited to continue for 1 year to assess safety and efficacy
376493|NCT00418314|B3|Baseline|Total|Total of all reporting groups
376494|NCT00418314|B2|Baseline|Control|Empiric programming or one-time optimization using a non-IEGM method.
376495|NCT00418314|B1|Baseline|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
376496|NCT00418314|P2|Participant Flow|Control|Empiric programming or one-time optimization using a non-IEGM method.
376497|NCT00418314|P1|Participant Flow|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
376498|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
376499|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
376500|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
376501|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
376502|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
376503|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
376504|NCT00418314|E2|Reported Event|Control|Empiric programming or one-time optimization using a non-IEGM method.
376505|NCT00418314|E1|Reported Event|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
376506|NCT00418379|B4|Baseline|Total|Total of all reporting groups
376507|NCT00418379|B3|Baseline|Placebo|Placebo tablet
376508|NCT00418379|B2|Baseline|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
376509|NCT00418379|B1|Baseline|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
376510|NCT00418379|P3|Participant Flow|Placebo|Placebo tablet
376511|NCT00418379|P2|Participant Flow|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
376512|NCT00418379|P1|Participant Flow|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
376513|NCT00418379|O3|Outcome|Placebo|Placebo tablet
376514|NCT00418379|O2|Outcome|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
376515|NCT00418379|O1|Outcome|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
376516|NCT00418379|E3|Reported Event|Placebo|Placebo tablet
376517|NCT00418379|E2|Reported Event|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
376518|NCT00418379|E1|Reported Event|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
376519|NCT00418522|B3|Baseline|Total|Total of all reporting groups
376520|NCT00418522|B2|Baseline|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376521|NCT00418522|B1|Baseline|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376522|NCT00418522|P2|Participant Flow|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376523|NCT00418522|P1|Participant Flow|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376524|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376525|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376526|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376527|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376528|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376529|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376530|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376531|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376532|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376533|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376534|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376535|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376536|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376537|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
377353|NCT00428597|B1|Baseline|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
376538|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376539|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376540|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376541|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376542|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376543|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376544|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376545|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376546|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376547|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376548|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376549|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376550|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376551|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376552|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376553|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376554|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376555|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376556|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376557|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376558|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376559|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376560|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
385519|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
376561|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376562|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376563|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376564|NCT00418522|E2|Reported Event|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
376565|NCT00418522|E1|Reported Event|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
376566|NCT00418561|B4|Baseline|Total|Total of all reporting groups
376567|NCT00418561|B3|Baseline|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376568|NCT00418561|B2|Baseline|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376642|NCT00418574|P2|Participant Flow|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
377354|NCT00428597|P2|Participant Flow|Placebo|Matching placebo.
376569|NCT00418561|B1|Baseline|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376570|NCT00418561|P3|Participant Flow|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376571|NCT00418561|P2|Participant Flow|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376572|NCT00418561|P1|Participant Flow|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376573|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376574|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376575|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376576|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376577|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376578|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376579|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376580|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376581|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376582|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376583|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376584|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376585|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376586|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376587|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376588|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376589|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376590|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376591|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376592|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376593|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376594|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376595|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376596|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376597|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376598|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376599|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376600|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376601|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376602|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376603|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376604|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376605|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376606|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376607|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376608|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376609|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376610|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376611|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376612|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376613|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376614|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376615|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376616|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376617|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376618|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376619|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376620|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376621|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376622|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376623|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376624|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376625|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376626|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376627|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376628|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376629|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376630|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376631|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376632|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376633|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376634|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376635|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376636|NCT00418561|E3|Reported Event|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376637|NCT00418561|E2|Reported Event|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376638|NCT00418561|E1|Reported Event|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
376639|NCT00418574|B3|Baseline|Total|Total of all reporting groups
376640|NCT00418574|B2|Baseline|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376641|NCT00418574|B1|Baseline|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376785|NCT00426842|O3|Outcome|Midodrine 10 mg|
376643|NCT00418574|P1|Participant Flow|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376644|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376645|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376646|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376647|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376648|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376649|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376650|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376651|NCT00418574|E2|Reported Event|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376652|NCT00418574|E1|Reported Event|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
376653|NCT00418665|B4|Baseline|Total|Total of all reporting groups
376654|NCT00418665|B3|Baseline|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376655|NCT00418665|B2|Baseline|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376656|NCT00418665|B1|Baseline|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376657|NCT00418665|P3|Participant Flow|Romiplostim (AMG 531) 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376658|NCT00418665|P2|Participant Flow|Romiplostim (AMG 531) 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376659|NCT00418665|P1|Participant Flow|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376660|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376661|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376662|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376663|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376664|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376665|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376666|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376667|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376668|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376669|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376670|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376671|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
376672|NCT00418665|E3|Reported Event|Romiplostim 750 µg|
376673|NCT00418665|E2|Reported Event|Romiplostim 500 µg|
376674|NCT00418665|E1|Reported Event|Placebo|
376675|NCT00418691|B4|Baseline|Total|Total of all reporting groups
376676|NCT00418691|B3|Baseline|Modafinil|18 mg PO once daily for 4 weeks
376677|NCT00418691|B2|Baseline|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
376678|NCT00418691|B1|Baseline|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
376679|NCT00418691|P3|Participant Flow|Modafinil|18 mg PO once daily for 4 weeks
376680|NCT00418691|P2|Participant Flow|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
376681|NCT00418691|P1|Participant Flow|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
376682|NCT00418691|O3|Outcome|Modafinil|18 mg PO once daily for 4 weeks
376683|NCT00418691|O2|Outcome|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
376684|NCT00418691|O1|Outcome|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
376685|NCT00418691|E3|Reported Event|Modafinil|18 mg PO once daily for 4 weeks
376686|NCT00418691|E2|Reported Event|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
376687|NCT00418691|E1|Reported Event|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
376688|NCT00418717|B1|Baseline|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)
Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
376689|NCT00418717|P1|Participant Flow|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)
Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
376690|NCT00418717|O1|Outcome|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)
Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
376786|NCT00426842|O2|Outcome|Midodrine 5 mg|
376787|NCT00426842|O1|Outcome|No-drug|
376691|NCT00418717|O1|Outcome|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)
Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
376692|NCT00418717|E1|Reported Event|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)
Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
376693|NCT00418834|B3|Baseline|Total|Total of all reporting groups
376694|NCT00418834|B2|Baseline|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376695|NCT00418834|B1|Baseline|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376696|NCT00418834|P2|Participant Flow|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376697|NCT00418834|P1|Participant Flow|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376698|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376699|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376700|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376701|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376702|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376703|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376704|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376705|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376706|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376707|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376708|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376709|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376710|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376711|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376712|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376713|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376714|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376715|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376716|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376717|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376718|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376719|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376720|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376721|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376722|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376723|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376724|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376725|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376726|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376727|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376728|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376729|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376730|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376731|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376732|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376733|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376734|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376735|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376736|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376737|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376738|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376739|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376740|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376741|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376742|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376743|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376744|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376745|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376746|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376747|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376748|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376749|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376750|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376751|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376752|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376753|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376754|NCT00418834|E2|Reported Event|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
376755|NCT00418834|E1|Reported Event|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
376756|NCT00418886|B3|Baseline|Total|Total of all reporting groups
376757|NCT00418886|B2|Baseline|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376758|NCT00418886|B1|Baseline|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376759|NCT00418886|P2|Participant Flow|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376760|NCT00418886|P1|Participant Flow|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376761|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376762|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376763|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376764|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376765|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376766|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376767|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376768|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376769|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376770|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376771|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376772|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376773|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376774|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
385520|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
376775|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376776|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376777|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376778|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376779|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376780|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376781|NCT00418886|E2|Reported Event|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376782|NCT00418886|E1|Reported Event|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
376783|NCT00426842|B1|Baseline|Arm 1|Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
376784|NCT00426842|P1|Participant Flow|All Participants|All participants underwent a head-up tilt maneuver following no-drug, midodrine 5 mg and midodrine 10 mg, in that order, on seperate study visits. Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
376788|NCT00426842|E1|Reported Event|All Participants|Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
376789|NCT00426855|B1|Baseline|Group 1|Bortezomib, Bendamustin, combination chemotherapy in nhl
376790|NCT00426855|P1|Participant Flow|Group 1|Bortezomib, Bendamustine, NHL, combination chemotherapy
376791|NCT00426855|O1|Outcome|Group 1|NHL treated with combination chemotherapy of bendamustin and bortezomib
376792|NCT00426855|E1|Reported Event|Group 1|NHL Patients treated with combination of bendamustine and bortezomib
376793|NCT00427011|B1|Baseline|Perampanel|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
376794|NCT00427011|P1|Participant Flow|Perampanel|Subjects entered this open-label extension study from the double-blind core study E2007-A001-214 (NCT00165789), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
376795|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
376796|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
376797|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
376798|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
376799|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
376800|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
376801|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
376824|NCT00427349|E1|Reported Event|MG 706+Octreotide|AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment. Each cycle was defined as 28 days. AMG 706 was started within 7 working days of registration, given on the same day as the octreotide-LAR.
376802|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
376803|NCT00427011|E1|Reported Event|Perampanel|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
376804|NCT00427037|B3|Baseline|Total|Total of all reporting groups
376805|NCT00427037|B2|Baseline|Cholecalciferol|This is vitamin D3 or Cholecalciferol
376806|NCT00427037|B1|Baseline|Placebo|This is a matching placebo
376807|NCT00427037|P2|Participant Flow|Cholecalciferol|This is vitamin D3 or Cholecalciferol
376808|NCT00427037|P1|Participant Flow|Placebo|This is a matching placebo
376809|NCT00427037|O2|Outcome|Cholecalciferol|This is vitamin D3 or Cholecalciferol
376810|NCT00427037|O1|Outcome|Placebo|This is a matching placebo
376811|NCT00427037|O2|Outcome|Cholecalciferol|"D3
Cholecalciferol: 50,000 IU weekly by mouth"
376812|NCT00427037|O1|Outcome|Placebo|"Placebo
Placebo: identical placebo pill orally by mouth"
376813|NCT00427037|E2|Reported Event|Cholecalciferol|This is vitamin D3 or Cholecalciferol
376814|NCT00427037|E1|Reported Event|Placebo|This is a matching placebo
376815|NCT00427336|B1|Baseline|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
376816|NCT00427336|P1|Participant Flow|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
376817|NCT00427336|O1|Outcome|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
376818|NCT00427336|E1|Reported Event|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
376819|NCT00427349|B1|Baseline|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.
octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
376820|NCT00427349|P1|Participant Flow|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.
octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
376821|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.
octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
376851|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376852|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376853|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376822|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.
octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
376823|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.
octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
376825|NCT00427557|B1|Baseline|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
376826|NCT00427557|P1|Participant Flow|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
376827|NCT00427557|O1|Outcome|Fludarabine + Melphalan + Umbilical Cord Blood Unit|Fludarabine 30 mg/m^2 given daily for four days. Melphalan 140 mg/m^2 given for one day. Umbilical Cord Blood Unit given on one day.
376828|NCT00427557|E1|Reported Event|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
376829|NCT00427635|B3|Baseline|Total|Total of all reporting groups
376830|NCT00427635|B2|Baseline|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376831|NCT00427635|B1|Baseline|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376832|NCT00427635|P2|Participant Flow|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376833|NCT00427635|P1|Participant Flow|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376834|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376835|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376836|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376837|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376838|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376839|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376840|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376841|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376842|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376843|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376844|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376845|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376846|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376847|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376848|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376849|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376850|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376894|NCT00427804|B1|Baseline|Healthy Control|
376895|NCT00427804|P2|Participant Flow|Crohn's Disease|Subjects with stable Crohn's disease
376854|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376855|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376856|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376857|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376858|NCT00427635|E2|Reported Event|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376859|NCT00427635|E1|Reported Event|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
376860|NCT00427661|B1|Baseline|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
376861|NCT00427661|P1|Participant Flow|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
376862|NCT00427661|O1|Outcome|Experimental|Busulfan, Fludarabine, Cyclosporine, MMF
376863|NCT00427661|O1|Outcome|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
376864|NCT00427661|O1|Outcome|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
376865|NCT00427661|E1|Reported Event|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
376866|NCT00427700|B3|Baseline|Total|Total of all reporting groups
376867|NCT00427700|B2|Baseline|Clomiphene|"Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle"
376868|NCT00427700|B1|Baseline|Raloxifene|"Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
raloxifene: 100mg PO on days 5-9 of the menstrual cycle"
376869|NCT00427700|P2|Participant Flow|Raloxiphene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
376870|NCT00427700|P1|Participant Flow|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
376871|NCT00427700|O2|Outcome|Raloxiphene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
376872|NCT00427700|O1|Outcome|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
376873|NCT00427700|O2|Outcome|Raloxifene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
376874|NCT00427700|O1|Outcome|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
376875|NCT00427700|E2|Reported Event|Raloxifene|"Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
raloxifene: 100mg PO on days 5-9 of the menstrual cycle
Two cases: one woman had nausea, and the other woman had nausea, headache, and pelvic pain. All mild"
376876|NCT00427700|E1|Reported Event|Clomiphene Citrate|"Use of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle
One woman in the CC group had nausea, headache, and abdominal bloating."
376877|NCT00427765|B1|Baseline|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
376878|NCT00427765|P1|Participant Flow|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
376879|NCT00427765|O1|Outcome|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
376880|NCT00427765|E1|Reported Event|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
376881|NCT00427791|B3|Baseline|Total|Total of all reporting groups
376882|NCT00427791|B2|Baseline|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
376883|NCT00427791|B1|Baseline|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
376884|NCT00427791|P2|Participant Flow|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
376885|NCT00427791|P1|Participant Flow|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
376886|NCT00427791|O2|Outcome|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
376887|NCT00427791|O1|Outcome|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
376888|NCT00427791|O2|Outcome|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
376889|NCT00427791|O1|Outcome|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
376890|NCT00427791|E2|Reported Event|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
376891|NCT00427791|E1|Reported Event|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
376892|NCT00427804|B3|Baseline|Total|Total of all reporting groups
376893|NCT00427804|B2|Baseline|Crohn's Disease|Subjects with stable Crohn's disease
376897|NCT00427804|O2|Outcome|Crohn's Disease|Subjects with stable Crohn's disease
376898|NCT00427804|O1|Outcome|Healthy Control|
376899|NCT00427804|E2|Reported Event|Crohn's Disease|Subjects with stable Crohn's disease
376900|NCT00427804|E1|Reported Event|Healthy Control|
376901|NCT00427895|B5|Baseline|Total|Total of all reporting groups
376902|NCT00427895|B4|Baseline|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376903|NCT00427895|B3|Baseline|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376904|NCT00427895|B2|Baseline|23vPS, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376905|NCT00427895|B1|Baseline|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
376906|NCT00427895|P8|Participant Flow|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
376907|NCT00427895|P7|Participant Flow|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
376908|NCT00427895|P6|Participant Flow|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
376909|NCT00427895|P5|Participant Flow|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
376910|NCT00427895|P4|Participant Flow|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
376911|NCT00427895|P3|Participant Flow|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1) at baseline.
376912|NCT00427895|P2|Participant Flow|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
376913|NCT00427895|P1|Participant Flow|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at baseline.
376914|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
376915|NCT00427895|O3|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose of open-label 23vPS (Vaccination 2) at Year 3 to 4.
376916|NCT00427895|O2|Outcome|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
376917|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
376918|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376919|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1) Year 0.
376920|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1) at Year 0.
376921|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at Year 0.
376922|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
376923|NCT00427895|O3|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
376924|NCT00427895|O2|Outcome|23vPS/23vPS, Cohort 1|Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
376925|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
376926|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376927|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1).
376928|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1).
376929|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
376930|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
376931|NCT00427895|O3|Outcome|23vPs/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
376932|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376995|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
376933|NCT00427895|O1|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
376934|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
376935|NCT00427895|O3|Outcome|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
376936|NCT00427895|O2|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
376937|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
376938|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376939|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376940|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376941|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
376942|NCT00427895|O3|Outcome|23vPs/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
376943|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376944|NCT00427895|O1|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
376945|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376946|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
376947|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376948|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1).
376949|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
376950|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
376951|NCT00427895|E16|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 3|Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
376952|NCT00427895|E15|Reported Event|13vPnC, Cohort 3|Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
376953|NCT00427895|E14|Reported Event|13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2|Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
376954|NCT00427895|E13|Reported Event|13vPnC/13vPnC, Cohort 2|Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
376955|NCT00427895|E12|Reported Event|23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
376956|NCT00427895|E11|Reported Event|23vPS/23vPS, Cohort 1|Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
376957|NCT00427895|E10|Reported Event|13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
376958|NCT00427895|E9|Reported Event|13vPnC/23vPS, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
376959|NCT00427895|E8|Reported Event|13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
376960|NCT00427895|E7|Reported Event|13vPnC/13vPnC, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
376961|NCT00427895|E6|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 2|Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
376962|NCT00427895|E5|Reported Event|13vPnC, Cohort 2|Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
377487|NCT00428974|O1|Outcome|CF101 1 mg BID|Oral tablets given every 12 hours for 12 weeks
376963|NCT00427895|E4|Reported Event|23vPS: 6 Month Follow-up After Vax 1, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
376964|NCT00427895|E3|Reported Event|23vPS, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
376965|NCT00427895|E2|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 1|Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
376966|NCT00427895|E1|Reported Event|13vPnC, Cohort 1|Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1 [Vax1]), reported after vaccination.
376967|NCT00427921|B1|Baseline|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376968|NCT00427921|P1|Participant Flow|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
377005|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
376969|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376970|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376971|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376972|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376973|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376974|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376975|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376976|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376977|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376978|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376979|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376980|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376981|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376982|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376983|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376984|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376985|NCT00427921|E1|Reported Event|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
376986|NCT00427934|B5|Baseline|Total|Total of all reporting groups
376987|NCT00427934|B4|Baseline|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
376988|NCT00427934|B3|Baseline|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
376989|NCT00427934|B2|Baseline|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
376990|NCT00427934|B1|Baseline|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
376991|NCT00427934|P4|Participant Flow|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
376992|NCT00427934|P3|Participant Flow|Maraviroc 300 mg BID (Proof-of-Concept [POC])|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
376993|NCT00427934|P2|Participant Flow|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
376994|NCT00427934|P1|Participant Flow|Maraviroc 150 mg BID (Pharmacokinetic [PK])|150 mg tablet was administered by mouth twice a day (BID) for 4 weeks with stable weekly doses of methotrexate (MTX).
376996|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
376997|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
376998|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
376999|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377000|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377001|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377002|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377003|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377004|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
399610|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
377006|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377007|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377008|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377009|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377010|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377011|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377012|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377013|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377014|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377015|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377016|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377017|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377018|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377019|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377020|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377021|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377022|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377023|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377024|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377025|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377026|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377027|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377028|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377029|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377030|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377031|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377032|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377033|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377034|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377035|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377036|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377037|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377038|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
385521|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
377039|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377040|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377041|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377042|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377043|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377044|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377045|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377046|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377047|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
378429|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
377048|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377049|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377050|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377051|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377052|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377053|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377054|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377055|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377056|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377057|NCT00427934|E4|Reported Event|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377058|NCT00427934|E3|Reported Event|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
377059|NCT00427934|E2|Reported Event|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377060|NCT00427934|E1|Reported Event|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
377061|NCT00427960|B3|Baseline|Total|Total of all reporting groups
377062|NCT00427960|B2|Baseline|Atorvastatin|atorvastatin 10 mg
377063|NCT00427960|B1|Baseline|Rosuvastatin|rosuvastatin 5 mg
377064|NCT00427960|P2|Participant Flow|Atorvastatin|atorvastatin 10 mg
377065|NCT00427960|P1|Participant Flow|Rosuvastatin|rosuvastatin 5 mg
377066|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377067|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377068|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377069|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377070|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377071|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377072|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377073|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377074|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377075|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377076|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377077|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377078|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377079|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377080|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377081|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377082|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377083|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377084|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377085|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377086|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377087|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377088|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377089|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377090|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377091|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377092|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377093|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377094|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
377095|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
377096|NCT00427960|E2|Reported Event|Atorvastatin|atorvastatin 10 mg
377097|NCT00427960|E1|Reported Event|Rosuvastatin|rosuvastatin 5 mg
377115|NCT00428077|P1|Participant Flow|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
377488|NCT00428974|O4|Outcome|Placebo|Oral tablets given every 12 hours for 12 weeks
377098|NCT00427973|B1|Baseline|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study"
377099|NCT00427973|P1|Participant Flow|Singe Arm Open Label Study With AZD2171 at 30 mg Daily.|Patients will receive AZD2171 by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies.
377120|NCT00428090|B3|Baseline|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377100|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study"
377101|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study"
377102|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study"
377103|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study"
377104|NCT00427973|E1|Reported Event|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) at 30 mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study"
377105|NCT00427999|B1|Baseline|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
377106|NCT00427999|P1|Participant Flow|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
377107|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
377108|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
377109|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
377110|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
377111|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
377112|NCT00427999|E2|Reported Event|STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Ext)|Extension follow-up
377113|NCT00427999|E1|Reported Event|STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Core)|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks (Core)
377114|NCT00428077|B1|Baseline|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
377489|NCT00428974|O3|Outcome|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
377116|NCT00428077|O1|Outcome|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients with Philadelphia Chromosome (Ph+) or Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL),positive Chronic Myeloid Leukemia(CML), in cytogenetic remission, with minimal residual disease.
377117|NCT00428077|E1|Reported Event|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
377118|NCT00428090|B5|Baseline|Total|Total of all reporting groups
377119|NCT00428090|B4|Baseline|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377121|NCT00428090|B2|Baseline|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377122|NCT00428090|B1|Baseline|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377123|NCT00428090|P4|Participant Flow|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377124|NCT00428090|P3|Participant Flow|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377125|NCT00428090|P2|Participant Flow|RSG XR 2 mg|Par. in this arm received rosiglitazone extended release (RSGXR) 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377126|NCT00428090|P1|Participant Flow|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377127|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377128|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377129|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377130|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377131|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377132|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377133|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377134|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377135|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377136|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377137|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
385522|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
377138|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377139|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377140|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377141|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
378430|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
377142|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377143|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377144|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377145|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377146|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377147|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377148|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377149|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377150|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377151|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377152|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377153|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377154|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377155|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377156|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377157|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377158|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377247|NCT00428116|O1|Outcome|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
377159|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377160|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377161|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377162|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377163|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377164|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377165|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377166|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377167|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4Wof treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377168|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377169|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377170|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377171|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377172|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377173|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377174|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377175|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377176|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377177|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377178|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377179|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377341|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
377180|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377181|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377182|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377183|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377184|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377185|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377186|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377187|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377188|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377189|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377190|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377191|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377192|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377193|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377194|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377195|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377196|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377197|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377198|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377199|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377200|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377490|NCT00428974|O2|Outcome|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
377201|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377202|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377203|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377204|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377205|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377206|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377207|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377208|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377209|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377210|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377211|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377212|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377213|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377214|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377215|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377216|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377217|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377218|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377219|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377220|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377221|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
385523|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
377222|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377223|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377224|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377348|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
399611|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
377225|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377226|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377227|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377228|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377229|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377230|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377231|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377232|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377233|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377234|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377235|NCT00428090|E4|Reported Event|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377236|NCT00428090|E3|Reported Event|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
377237|NCT00428090|E2|Reported Event|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377238|NCT00428090|E1|Reported Event|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
377239|NCT00428116|B3|Baseline|Total|Total of all reporting groups
377240|NCT00428116|B2|Baseline|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
377241|NCT00428116|B1|Baseline|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
377242|NCT00428116|P2|Participant Flow|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
377243|NCT00428116|P1|Participant Flow|Continued HAART|After 24 months of HAART, infants were continued on HAART.
377244|NCT00428116|O2|Outcome|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
377245|NCT00428116|O1|Outcome|Continue HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
377246|NCT00428116|O2|Outcome|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
377248|NCT00428116|E2|Reported Event|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
377249|NCT00428116|E1|Reported Event|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
377250|NCT00428207|B1|Baseline|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.
Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization.
insulin pump :"
377349|NCT00428584|E2|Reported Event|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
377251|NCT00428207|P2|Participant Flow|Insulin Aspart|"Subjects will be randomly assigned to one of the two insulins (insulin Aspart) by the statistician working in the study via random number generation.
First Intervention- four weeks using insulin Aspart in the pump. Subjects will use their current basal rates, insulin to carb ratios and correction factors to dose insulin.
After the four weeks of the first intervention have been completed subjects will be switched to insulin lispro, for the second intervention period.
The sequence of interventions may be reversed due to random assignment of treatment."
377252|NCT00428207|P1|Participant Flow|Insulin Lispro|"Subjects will be randomly assigned to one of the two insulins (insulin Lispro) by the statistician working in the study via random number generation.
First Intervention- four weeks using insulin Aspart in the pump. Subjects will use their current basal rates, insulin to carb ratios and correction factors to dose insulin.
After the four weeks of the first intervention have been completed subjects will be switched to insulin lispro, for the second intervention period.
The sequence of interventions may be reversed due to random assignment of treatment."
377253|NCT00428207|O1|Outcome|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.
Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization.
insulin pump :"
377254|NCT00428207|O2|Outcome|Insulin Lispro Versus Insulin Aspart|"Insulin lispro will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Dose will be adjusted as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Aspart).
Insulin Lispro versus Insulin Aspart: Subjects will be randomly assigned to insulin lispro versus insulin aspart via random number generation. Half of the patients will begin with insulin lispro, and then will be crossed over to insulin aspart. The insulin sequence will be reversed for the other half of the patients."
377255|NCT00428207|O1|Outcome|Insulin Aspart Versus Insulin Lispro|"Insulin aspart will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Insulin aspart doses will be adjusted by the principal investigator as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Lispro).
Insulin Aspart versus Insulin Lispro: Subjects will be randomly assigned to insulin aspart versus insulin lispro via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients."
377256|NCT00428207|E1|Reported Event|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.
Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization."
377257|NCT00428220|B1|Baseline|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
377258|NCT00428220|P1|Participant Flow|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
377259|NCT00428220|O11|Outcome|Sunitinib 11|Parent Study: A6181170
377260|NCT00428220|O10|Outcome|Sunitinib 10|Parent Study: A6181126
377261|NCT00428220|O9|Outcome|Sunitinib 9|Parent Study: A6181120
377262|NCT00428220|O8|Outcome|Sunitinib 8|Parent Study: A6181113
377263|NCT00428220|O7|Outcome|Sunitinib 7|Parent Study: A6181112
377264|NCT00428220|O6|Outcome|Sunitinib 6|Parent Study: A6181111
377265|NCT00428220|O5|Outcome|Sunitinib 5|Parent Study: A6181110
377266|NCT00428220|O4|Outcome|Sunitinib 4|Parent Study: A6181107
377267|NCT00428220|O3|Outcome|Sunitinib 3|Parent Study: A6181094
377268|NCT00428220|O2|Outcome|Sunitinib 2|Parent Study: A6181087
377269|NCT00428220|O1|Outcome|Sunitinib 1|Parent Study: A6181078
377342|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
377343|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
377491|NCT00428974|O1|Outcome|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
377270|NCT00428220|O1|Outcome|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
377271|NCT00428220|O1|Outcome|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
377272|NCT00428220|E1|Reported Event|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
377273|NCT00428246|B4|Baseline|Total|Total of all reporting groups
377274|NCT00428246|B3|Baseline|3|Placebo
377275|NCT00428246|B2|Baseline|2|2 mcg paricalcitol
377276|NCT00428246|B1|Baseline|1|1 mcg paricalcitol
377277|NCT00428246|P3|Participant Flow|3|Placebo
377278|NCT00428246|P2|Participant Flow|2|2 mcg paricalcitol
377279|NCT00428246|P1|Participant Flow|1|1 mcg paricalcitol
377280|NCT00428246|O3|Outcome|3|Placebo
377281|NCT00428246|O2|Outcome|2|2 mcg paricalcitol
377282|NCT00428246|O1|Outcome|1|1 mcg paricalcitol
377283|NCT00428246|E3|Reported Event|3|Placebo
377284|NCT00428246|E2|Reported Event|2|2 mcg paricalcitol
377285|NCT00428246|E1|Reported Event|1|1 mcg paricalcitol
377286|NCT00428298|B3|Baseline|Total|Total of all reporting groups
377287|NCT00428298|B2|Baseline|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
377288|NCT00428298|B1|Baseline|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
377289|NCT00428298|P2|Participant Flow|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
377290|NCT00428298|P1|Participant Flow|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
377291|NCT00428298|O2|Outcome|Inactive Treatment Group - Placebo|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
377292|NCT00428298|O1|Outcome|Active Treatment Group - Valcyclovir|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
377293|NCT00428298|O2|Outcome|Inactive Treatment Group - Placebo|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
377294|NCT00428298|O1|Outcome|Active Treatment Group - Valcyclovir|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
377295|NCT00428298|O2|Outcome|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
377296|NCT00428298|O1|Outcome|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
377297|NCT00428298|E2|Reported Event|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
377298|NCT00428298|E1|Reported Event|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
377299|NCT00428389|B3|Baseline|Total|Total of all reporting groups
377300|NCT00428389|B2|Baseline|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377301|NCT00428389|B1|Baseline|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377302|NCT00428389|P2|Participant Flow|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377303|NCT00428389|P1|Participant Flow|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377304|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377350|NCT00428584|E1|Reported Event|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
377351|NCT00428597|B3|Baseline|Total|Total of all reporting groups
377305|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377306|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377307|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377308|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377309|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377310|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377311|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377312|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377313|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377314|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377315|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377316|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377317|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377318|NCT00428389|E2|Reported Event|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377319|NCT00428389|E1|Reported Event|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
377320|NCT00428441|B1|Baseline|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
377321|NCT00428441|P1|Participant Flow|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
377322|NCT00428441|O1|Outcome|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
377323|NCT00428441|E1|Reported Event|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
377324|NCT00428584|B3|Baseline|Total|Total of all reporting groups
377325|NCT00428584|B2|Baseline|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
377326|NCT00428584|B1|Baseline|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
377327|NCT00428584|P2|Participant Flow|Betaseron|
377328|NCT00428584|P1|Participant Flow|New Formulation of Rebif|The new formulation of rebif is not approved and under investigation in the US
377329|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
377330|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
377331|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
377332|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
377333|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
377334|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
377335|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
377336|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
377337|NCT00428584|O2|Outcome|Betaseron to New Formulation of Rebif|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
377338|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, new formualation of rebif- 44 mcg, subcutaneous injection, three times a week
377339|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
377340|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
377344|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
377345|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
377346|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
377347|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
377352|NCT00428597|B2|Baseline|Placebo|Matching placebo.
377355|NCT00428597|P1|Participant Flow|Sunitinib|Oral sunitinib 37.5 milligrams (mg) once daily on a continuous daily dosing schedule.
377356|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377357|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377358|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377359|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377360|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377361|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377362|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377363|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377364|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377365|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377366|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377367|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377368|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377369|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377370|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377371|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377372|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377373|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377374|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377375|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377376|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377377|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377378|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377379|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377380|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377381|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377382|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377383|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377384|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377385|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377386|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377387|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377388|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377389|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377390|NCT00428597|O2|Outcome|Placebo|Matching placebo.
377391|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377392|NCT00428597|E2|Reported Event|Placebo|Matching placebo.
377393|NCT00428597|E1|Reported Event|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
377394|NCT00428792|B3|Baseline|Total|Total of all reporting groups
377395|NCT00428792|B2|Baseline|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377396|NCT00428792|B1|Baseline|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377397|NCT00428792|P2|Participant Flow|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377492|NCT00428974|E4|Reported Event|Placebo|Oral tablets given every 12 hours for 12 weeks
377398|NCT00428792|P1|Participant Flow|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377399|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377400|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377401|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377402|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377403|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377404|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377405|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377406|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377407|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377408|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377409|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377410|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377411|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377412|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377438|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
377413|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377414|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377415|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
399613|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
377416|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377417|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377418|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377419|NCT00428792|E2|Reported Event|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
377420|NCT00428792|E1|Reported Event|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
377421|NCT00428844|B4|Baseline|Total|Total of all reporting groups
377422|NCT00428844|B3|Baseline|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
377423|NCT00428844|B2|Baseline|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377424|NCT00428844|B1|Baseline|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377425|NCT00428844|P3|Participant Flow|Comparator|Vancomycin was administered at 1 gram (gm)every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
377426|NCT00428844|P2|Participant Flow|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
377427|NCT00428844|P1|Participant Flow|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg every 24 hours [q24h]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
377428|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377429|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377430|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377431|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377432|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
377433|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377434|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377435|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
377436|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377437|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377439|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377440|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377441|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
377442|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377443|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377444|NCT00428844|E3|Reported Event|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
377445|NCT00428844|E2|Reported Event|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377446|NCT00428844|E1|Reported Event|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
377770|NCT00421928|P1|Participant Flow|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
377447|NCT00428922|B1|Baseline|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
377448|NCT00428922|P1|Participant Flow|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
377449|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
377450|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
377451|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
377452|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
377453|NCT00428922|E1|Reported Event|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
377454|NCT00428948|B3|Baseline|Total|Total of all reporting groups
377455|NCT00428948|B2|Baseline|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
377456|NCT00428948|B1|Baseline|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
377457|NCT00428948|P2|Participant Flow|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
377458|NCT00428948|P1|Participant Flow|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
377459|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
377460|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
377461|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
377462|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
377463|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
377464|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
377465|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
377466|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
377467|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
377468|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
377469|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
377470|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
377471|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
377472|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
377473|NCT00428948|E2|Reported Event|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
377474|NCT00428948|E1|Reported Event|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
377475|NCT00428974|B5|Baseline|Total|Total of all reporting groups
377476|NCT00428974|B4|Baseline|Placebo|Oral tablets given every 12 hours for 12 weeks
377477|NCT00428974|B3|Baseline|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
377478|NCT00428974|B2|Baseline|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
377479|NCT00428974|B1|Baseline|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
377480|NCT00428974|P4|Participant Flow|Placebo|Oral tablets given every 12 hours for 12 weeks
377481|NCT00428974|P3|Participant Flow|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
377482|NCT00428974|P2|Participant Flow|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
377483|NCT00428974|P1|Participant Flow|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
377484|NCT00428974|O4|Outcome|Placebo|Oral tablets given every 12 hours for 12 weeks
377485|NCT00428974|O3|Outcome|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
377486|NCT00428974|O2|Outcome|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
377493|NCT00428974|E3|Reported Event|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
377494|NCT00428974|E2|Reported Event|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
377495|NCT00428974|E1|Reported Event|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
377496|NCT00429026|B1|Baseline|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
377497|NCT00429026|P1|Participant Flow|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
377498|NCT00429026|O1|Outcome|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
377499|NCT00429026|E1|Reported Event|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
377500|NCT00429104|B1|Baseline|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
377771|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
377501|NCT00429104|P1|Participant Flow|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
377502|NCT00429104|O1|Outcome|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
377503|NCT00429104|O1|Outcome|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
377504|NCT00429104|E1|Reported Event|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
377505|NCT00429143|B1|Baseline|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
377506|NCT00429143|P1|Participant Flow|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
377507|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
377508|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
377509|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
377510|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
377511|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
377512|NCT00429143|E1|Reported Event|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
377513|NCT00429169|B3|Baseline|Total|Total of all reporting groups
377514|NCT00429169|B2|Baseline|Bupropion|Participants will receive bupropion for 8 weeks
377515|NCT00429169|B1|Baseline|Paroxetine|Participants will receive paroxetine for 8 weeks
377516|NCT00429169|P2|Participant Flow|Bupropion|Participants will receive bupropion for 8 weeks
377517|NCT00429169|P1|Participant Flow|Paroxetine|Participants will receive paroxetine for 8 weeks
377518|NCT00429169|O2|Outcome|Bupropion|Participants will receive bupropion for 8 weeks
377519|NCT00429169|O1|Outcome|Paroxetine|Participants will receive paroxetine for 8 weeks
377520|NCT00429169|O2|Outcome|Bupropion|Bupropion acute treatment for 8 weeks.
377521|NCT00429169|O1|Outcome|Paroxetine|Paroxetine acute treatment for 8 weeks.
377522|NCT00429169|O2|Outcome|Bupropion|Participants will receive bupropion for 8 weeks
377523|NCT00429169|O1|Outcome|Paroxetine|Participants will receive paroxetine for 8 weeks
377524|NCT00429169|E2|Reported Event|Bupropion|Participants will receive bupropion for 8 weeks
377525|NCT00429169|E1|Reported Event|Paroxetine|Participants will receive paroxetine for 8 weeks
377526|NCT00429182|B1|Baseline|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa
Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Stem Cell Transplant : Stem Cell Transplant on Day 0.
Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
377527|NCT00429182|P1|Participant Flow|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa
Carboplatin : Target area under the curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Stem Cell Transplant : Stem Cell Transplant on Day 0.
Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
377528|NCT00429182|O1|Outcome|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa
Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Stem Cell Transplant : Stem Cell Transplant on Day 0.
Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
377529|NCT00429182|O1|Outcome|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa
Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Stem Cell Transplant : Stem Cell Transplant on Day 0.
Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
377530|NCT00429182|E1|Reported Event|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa
Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Stem Cell Transplant : Stem Cell Transplant on Day 0.
Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
377531|NCT00429273|B4|Baseline|Total|Total of all reporting groups
377532|NCT00429273|B3|Baseline|Group 3: Guan-Guan+DMPH (Comb)|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb)
377533|NCT00429273|B2|Baseline|Group 2: Placebo-Placebo+DMPH|weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
377534|NCT00429273|B1|Baseline|Group 1: Guan-Guan+Placebo|weeks 1-4: Guanfacine weeks 5-8: Guanfacine +Placebo
377535|NCT00429273|P3|Participant Flow|Group 3: Guan-Guan+DMPH|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb)
377536|NCT00429273|P2|Participant Flow|Group 2: Placebo-Placebo+DMPH|weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
377537|NCT00429273|P1|Participant Flow|Group 1: Guan-Guan+Placebo|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+Placebo
377538|NCT00429273|O3|Outcome|Estimated Difference Between Placebo and Combo|Contrasts based on all observations of patients treated with combo and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for DMPH are based on the guan-combo arm at 8 weeks. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
377772|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
377539|NCT00429273|O2|Outcome|Estimated Difference Between DMPH and Placebo|Contrasts based on all observations of patients treated with dmph and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for DMPH are based on the placebo-guan arm at 8 weeks. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
377540|NCT00429273|O1|Outcome|Estimated Difference Between Guan and Placebo|Contrasts based on all observations of patients treated with guam and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for guan are based on the guan-guan arm both at 4 weeks and 8 weeks, and the guan-combo arm at 4 weeks only. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
377541|NCT00429273|E3|Reported Event|Group 3: Guan-Guan+DMPH|week 1-4: Guanfacine week 5-8: Guanfacine+DMPH (comb)
377542|NCT00429273|E2|Reported Event|Group 2: Placebo-Placebo+DMPH|week 1-4: Placebo week 5-8: Placebo+DMPH
377543|NCT00429273|E1|Reported Event|Group 1: Guan-Guan+Placebo|week 1-4: Guanfacine weeks 5-8: Guanfacine+Placebo
377544|NCT00429299|B4|Baseline|Total|Total of all reporting groups
377545|NCT00429299|B3|Baseline|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
377546|NCT00429299|B2|Baseline|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
377547|NCT00429299|B1|Baseline|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
377548|NCT00429299|P3|Participant Flow|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
377549|NCT00429299|P2|Participant Flow|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
377550|NCT00429299|P1|Participant Flow|Chemotherapy (CT) Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
377582|NCT00429364|P1|Participant Flow|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377551|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
377657|NCT00429494|E1|Reported Event|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
377552|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
377553|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
377554|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
377555|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
377556|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
377557|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
377558|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
377559|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
377583|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377584|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377585|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377833|NCT00421993|E3|Reported Event|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
377560|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
377561|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
377562|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
377563|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
377564|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
377565|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
377566|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
377567|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
377568|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
377586|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377587|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377588|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377569|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
377570|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
377571|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
377572|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
377573|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.
Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
377574|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
377575|NCT00429299|E3|Reported Event|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
377576|NCT00429299|E2|Reported Event|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
377577|NCT00429299|E1|Reported Event|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
377578|NCT00429364|B3|Baseline|Total|Total of all reporting groups
377579|NCT00429364|B2|Baseline|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377580|NCT00429364|B1|Baseline|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377581|NCT00429364|P2|Participant Flow|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377589|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377590|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377591|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377655|NCT00429494|P1|Participant Flow|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.
377592|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377593|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377594|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377595|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377596|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377597|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377598|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377599|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377600|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377601|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377602|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377603|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377604|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377605|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377606|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377607|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377608|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377609|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377610|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377611|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377612|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377613|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377614|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377615|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377616|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377617|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377618|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377619|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377834|NCT00421993|E2|Reported Event|Adapalene Gel|Adapalene Topical Gel
377835|NCT00421993|E1|Reported Event|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
377620|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377621|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377656|NCT00429494|O1|Outcome|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
377622|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377623|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377624|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377625|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377626|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377627|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377628|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377629|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377630|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377631|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377632|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377633|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377634|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377635|NCT00429364|E2|Reported Event|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
377636|NCT00429364|E1|Reported Event|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
377637|NCT00429403|B3|Baseline|Total|Total of all reporting groups
377638|NCT00429403|B2|Baseline|No Goserelin|
377639|NCT00429403|B1|Baseline|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
377640|NCT00429403|P2|Participant Flow|No Goserelin|
377641|NCT00429403|P1|Participant Flow|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
377642|NCT00429403|O2|Outcome|No Goserelin|
377643|NCT00429403|O1|Outcome|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
377644|NCT00429403|E2|Reported Event|No Goserelin|
377645|NCT00429403|E1|Reported Event|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
377646|NCT00429416|B1|Baseline|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
377647|NCT00429416|P1|Participant Flow|LLME to Decrease GVHD Following HSC T|"To determine if an experimental agent, L-leucyl-L-leucine Methyl Ester (LLME), can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
Treatment Outline:
Day -6: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV Day -5: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -4: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -3: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -2: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -1: Rest day Day 0: CD34 selected allogeneic stem cell infusion with 5x104/kg untreated T cells Day 1: Infusion of LLME treated donor CD34 – cells"
377648|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
377649|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
377650|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
377651|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
377652|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
377836|NCT00422032|B3|Baseline|Total|Total of all reporting groups
377653|NCT00429416|E1|Reported Event|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
377654|NCT00429494|B1|Baseline|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
377658|NCT00429507|B1|Baseline|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
377659|NCT00429507|P1|Participant Flow|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
377660|NCT00429507|O1|Outcome|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
377661|NCT00429507|E1|Reported Event|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
377662|NCT00429572|B1|Baseline|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
377663|NCT00429572|P1|Participant Flow|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
377664|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
377665|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
377666|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
377667|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
377668|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
377669|NCT00429572|E1|Reported Event|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
377670|NCT00429663|B3|Baseline|Total|Total of all reporting groups
377671|NCT00429663|B2|Baseline|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment
locking periarticular plate: Standard of care device for femur fractures"
377672|NCT00429663|B1|Baseline|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment
reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
377673|NCT00429663|P2|Participant Flow|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment
locking periarticular plate: Standard of care device for femur fractures"
377674|NCT00429663|P1|Participant Flow|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment
reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
377675|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment
locking periarticular plate: Standard of care device for femur fractures"
377676|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment
reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
377677|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment
locking periarticular plate: Standard of care device for femur fractures"
377678|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment
reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
377679|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment
locking periarticular plate: Standard of care device for femur fractures"
377680|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment
reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
377681|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment
locking periarticular plate: Standard of care device for femur fractures"
377682|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment
reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
377683|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment
locking periarticular plate: Standard of care device for femur fractures"
377684|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment
reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
377685|NCT00429663|E2|Reported Event|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment
locking periarticular plate: Standard of care device for femur fractures"
377686|NCT00429663|E1|Reported Event|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment
reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
377687|NCT00429702|B3|Baseline|Total|Total of all reporting groups
385524|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
377688|NCT00429702|B2|Baseline|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.
Decadron®: Given IV
ondansetron hydrochloride: Given IV"
377689|NCT00429702|B1|Baseline|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.
Decadron®: Given IV
Benadryl®: Given IV
Ativan®: Given IV
ondansetron hydrochloride: Given IV"
377765|NCT00421928|B3|Baseline|Placebo|Matching Placebo twice daily (BID)
377766|NCT00421928|B2|Baseline|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
399614|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
377690|NCT00429702|P2|Participant Flow|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.
Decadron®: Given IV
ondansetron hydrochloride: Given IV"
377691|NCT00429702|P1|Participant Flow|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.
Decadron®: Given IV
Benadryl®: Given IV
Ativan®: Given IV
ondansetron hydrochloride: Given IV"
377692|NCT00429702|O2|Outcome|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.
Decadron®: Given IV
ondansetron hydrochloride: Given IV"
377693|NCT00429702|O1|Outcome|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.
Decadron®: Given IV
Benadryl®: Given IV
Ativan®: Given IV
ondansetron hydrochloride: Given IV"
377694|NCT00429702|O2|Outcome|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.
Decadron®: Given IV
ondansetron hydrochloride: Given IV"
377695|NCT00429702|O1|Outcome|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.
Decadron®: Given IV
Benadryl®: Given IV
Ativan®: Given IV
ondansetron hydrochloride: Given IV"
377696|NCT00429702|E2|Reported Event|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.
Decadron®: Given IV
ondansetron hydrochloride: Given IV"
377697|NCT00429702|E1|Reported Event|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.
Decadron®: Given IV
Benadryl®: Given IV
Ativan®: Given IV
ondansetron hydrochloride: Given IV"
377698|NCT00429793|B1|Baseline|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
377699|NCT00429793|P1|Participant Flow|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
377700|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
377701|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
377702|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
377703|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
377704|NCT00429793|E1|Reported Event|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
377705|NCT00421889|B10|Baseline|Total|Total of all reporting groups
377706|NCT00421889|B9|Baseline|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
377707|NCT00421889|B8|Baseline|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
377708|NCT00421889|B7|Baseline|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
377709|NCT00421889|B6|Baseline|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377710|NCT00421889|B5|Baseline|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377837|NCT00422032|B2|Baseline|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
377711|NCT00421889|B4|Baseline|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377712|NCT00421889|B3|Baseline|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377767|NCT00421928|B1|Baseline|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
377713|NCT00421889|B2|Baseline|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377714|NCT00421889|B1|Baseline|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377715|NCT00421889|P9|Participant Flow|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
377716|NCT00421889|P8|Participant Flow|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
377717|NCT00421889|P7|Participant Flow|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
377718|NCT00421889|P6|Participant Flow|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377719|NCT00421889|P5|Participant Flow|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377720|NCT00421889|P4|Participant Flow|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377721|NCT00421889|P3|Participant Flow|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377722|NCT00421889|P2|Participant Flow|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377723|NCT00421889|P1|Participant Flow|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 (area under the curve) administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377724|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
377725|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
377726|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
377727|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
377728|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
377729|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
377730|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
377731|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
377732|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
377733|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
377734|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
377735|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
377736|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
377737|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
377738|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
377739|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
377740|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
377762|NCT00421889|E2|Reported Event|Part B: Ovarian Cancer MTD (N=35)|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377741|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
377768|NCT00421928|P3|Participant Flow|Placebo|Matching Placebo twice daily (BID)
377769|NCT00421928|P2|Participant Flow|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
377742|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377743|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
377744|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
377745|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377746|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
377747|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
377748|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377749|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
377750|NCT00421889|O9|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
377751|NCT00421889|O8|Outcome|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
377752|NCT00421889|O7|Outcome|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
377753|NCT00421889|O6|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377754|NCT00421889|O5|Outcome|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377755|NCT00421889|O4|Outcome|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377756|NCT00421889|O3|Outcome|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377757|NCT00421889|O2|Outcome|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377758|NCT00421889|O1|Outcome|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377759|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
377760|NCT00421889|E4|Reported Event|Part D: Bladder Cancer MTD (N=15)|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
377761|NCT00421889|E3|Reported Event|Part C: 3-6 Hours Infusion (N=7)|PXD: 1000 mg/m² was administered as a 3 or 6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
377831|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
377763|NCT00421889|E1|Reported Event|Part A: Dose Escalation (N=23)|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
377764|NCT00421928|B4|Baseline|Total|Total of all reporting groups
377773|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
377774|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
377775|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
377776|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
377777|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
377778|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
377779|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
377780|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
377781|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
377782|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
377783|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
377784|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
377785|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
377786|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
377787|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
377788|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
377789|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
377790|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
377791|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
377792|NCT00421928|E3|Reported Event|Placebo|Matching Placebo twice daily (BID)
377793|NCT00421928|E2|Reported Event|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
377794|NCT00421928|E1|Reported Event|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
377795|NCT00421954|B1|Baseline|Ziprasidone|Ziprasidone: subjects will use ziprasidone
377796|NCT00421954|P1|Participant Flow|Ziprasidone|Ziprasidone: subjects will use ziprasidone
377797|NCT00421954|O1|Outcome|Ziprasidone|Ziprasidone: subjects will use ziprasidone
377798|NCT00421954|E1|Reported Event|Ziprasidone|Ziprasidone: subjects will use ziprasidone
377799|NCT00421993|B5|Baseline|Total|Total of all reporting groups
377800|NCT00421993|B4|Baseline|Gel Vehicle|Topical Gel Vehicle
377801|NCT00421993|B3|Baseline|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
377802|NCT00421993|B2|Baseline|Adapalene Gel|Adapalene Topical Gel
377803|NCT00421993|B1|Baseline|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
377804|NCT00421993|P4|Participant Flow|Gel Vehicle|Topical Gel Vehicle
377805|NCT00421993|P3|Participant Flow|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
377806|NCT00421993|P2|Participant Flow|Adapalene Gel|Adapalene Topical Gel
377807|NCT00421993|P1|Participant Flow|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
377808|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
377809|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
377810|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
377811|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
377812|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
377813|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
377814|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
377815|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
377816|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
377817|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
377818|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
377819|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
377820|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
377821|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
377822|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
377823|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
377824|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
377825|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
377826|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
377827|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
377828|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
377829|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
377830|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
377838|NCT00422032|B1|Baseline|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
377839|NCT00422032|P2|Participant Flow|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
377840|NCT00422032|P1|Participant Flow|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
377841|NCT00422032|O2|Outcome|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
377842|NCT00422032|O1|Outcome|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
377843|NCT00422032|E2|Reported Event|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
377844|NCT00422032|E1|Reported Event|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
377845|NCT00422058|B7|Baseline|Total|Total of all reporting groups
378104|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
377846|NCT00422058|B6|Baseline|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377847|NCT00422058|B5|Baseline|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377848|NCT00422058|B4|Baseline|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377849|NCT00422058|B3|Baseline|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377850|NCT00422058|B2|Baseline|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377851|NCT00422058|B1|Baseline|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377852|NCT00422058|P6|Participant Flow|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377853|NCT00422058|P5|Participant Flow|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377854|NCT00422058|P4|Participant Flow|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377855|NCT00422058|P3|Participant Flow|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377856|NCT00422058|P2|Participant Flow|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377857|NCT00422058|P1|Participant Flow|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377858|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377859|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377860|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377861|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377862|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377863|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377864|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
378088|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
377865|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377866|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377867|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
378105|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
378106|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
377868|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377869|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377870|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377871|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377872|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377873|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377874|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377875|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377876|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377877|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377878|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377879|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377880|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377881|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377882|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377883|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377884|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377885|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377886|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377887|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
378089|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
377888|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377889|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377890|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377891|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377892|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377893|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377894|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377895|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377896|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377897|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377898|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377899|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377900|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377901|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377902|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377903|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377904|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377905|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377906|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377907|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377908|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377909|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377910|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
378094|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
385525|NCT00438451|E3|Reported Event|Lamotrigine|Lamotrigine 25mg
377911|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377912|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377936|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377913|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377914|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377915|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377916|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377917|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377918|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377919|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377920|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377921|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377922|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377923|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377924|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377925|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377926|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377927|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377928|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377929|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377930|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377931|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377932|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377933|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
378095|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
377934|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377935|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377937|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377938|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377939|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377940|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377941|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377942|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377943|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377944|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377945|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377946|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377947|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377948|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377949|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377950|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377951|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377952|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377953|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377954|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377955|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377956|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
378096|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
377957|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377958|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377959|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377960|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377961|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377962|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377963|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377964|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377965|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377966|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377967|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377968|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377969|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377970|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377971|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377972|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377973|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377974|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377975|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377976|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377977|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377978|NCT00422058|E6|Reported Event|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
377979|NCT00422058|E5|Reported Event|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
378097|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
377980|NCT00422058|E4|Reported Event|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377981|NCT00422058|E3|Reported Event|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377982|NCT00422058|E2|Reported Event|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377983|NCT00422058|E1|Reported Event|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
377984|NCT00422097|B7|Baseline|Total|Total of all reporting groups
377985|NCT00422097|B6|Baseline|Ixabepilone, 30 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 30 mg, on Days 1 through 5 every 21 days.
377986|NCT00422097|B5|Baseline|Ixabepilone, 25 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 25 mg, on Days 1 through 5 every 21 days.
377987|NCT00422097|B4|Baseline|Ixabepilone, 20 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 20 mg, on Days 1 through 5 every 21 days.
377988|NCT00422097|B3|Baseline|Ixabepilone, 15 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 15 mg, on Days 1 through 5 every 21 days.
377989|NCT00422097|B2|Baseline|Ixabepilone, 10 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 10 mg, on Days 1 through 5 every 21 days.
377990|NCT00422097|B1|Baseline|Ixabepilone, 5 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 5 mg, on Days 1 through 5 every 21 days.
377991|NCT00422097|P8|Participant Flow|Ixabepilone, MTD (25 mg), With Food|Cohort opened for Cycle 2, after ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, once daily in an oral dose on Days 1 through 5. On all dosing days in Cycle 1, participants fasted at least 4 hours before and 4 hours after dosing. Then participants crossed over to Cycle 2. On Day 1 of Cycle 2, participants allowed a low-fat meal. Participants ingest the specified meal within a 30-minute period and receive ixabepilone, 25 mg, 30 minutes after start of the meal. For the duration of Cycle 2, participants fast 1 hour before and 2 hours after ixabepilone dose.
377992|NCT00422097|P7|Participant Flow|Ixabepilone, MTD (25 mg), With Famotidine|Cohort opened for Cycle 2, once ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, alone, orally once per day on Days 1 through 21. Then participants crossed over to receive famotidine wirh ixabepilone in Cycle 2. Prior to dosing on Day 1 of Cycle 2, famotidine, 40 mg, administered in an oral dose 2 hours before ixabepilone 25-mg dose.
377993|NCT00422097|P6|Participant Flow|Ixabepilone, 30 mg/d|Ixabepilone, 30 mg, given daily orally on Days 1 through 5 every 21 days. If 2 or more of the first 3 participants experience a DLT within the first 21-day course, this dose level will be considered above the MTD. If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD (the maximum dose that can be given to 6 participants without producing a DLT in more than 1 [or fewer than 1/3 if more than 6 participants in cohort)]. On all dosing days in Cycle 1, participants to fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
377994|NCT00422097|P5|Participant Flow|Ixabepilone, 25 mg/d|Ixabepilone, 25 mg/d, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT in the first 21-day course, a new cohort is opened at the next dose level (30 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD. The MTD is the maximum dose that can be given to 6 participants without producing a DLT in more than 1 participant (or fewer than 1/3 if the cohort has more than 6 participants). More participants may be enrolled at any level to provide additional safety data. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
377995|NCT00422097|P4|Participant Flow|Ixabepilone, 20 mg/d|Ixabepilone, 20 mg, given daily in oral doses on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (25 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
377996|NCT00422097|P3|Participant Flow|Ixabepilone, 15 mg/d|Ixabepilone, 15 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (20 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
377997|NCT00422097|P2|Participant Flow|Ixabepilone, 10 mg/d|Ixabepilone, 10 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (15 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
378090|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
385526|NCT00438451|E2|Reported Event|Carbamazepine|Carbamazepine 100mg
377998|NCT00422097|P1|Participant Flow|Ixabepilone, 5 mg/d|Ixabepilone, 5 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a dose-limiting toxicity (DLT) in the first 21-day course, a new cohort is opened at the next dose level (10 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
377999|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378103|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378000|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378001|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378002|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378003|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378004|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378005|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378006|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|Participants who received MTD (25 mg) ixabepilone without famotidine and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine. Fasted/Fed criteria: Cycle 1: Dose 1 administered after a minimum of a 4-hour fast. Cycle 2: Dose 1 administered with a low-fat meal to crossover cohort.
378007|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|Participants received MTD (25 mg) ixabepilone without famotidine (Cycle 1) and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone (with famotidine (Cycle 2). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after ixabepilone treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
378008|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
378009|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
378010|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
378011|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
378012|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378013|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378014|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378015|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378016|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378017|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378018|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378019|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378020|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378091|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378411|NCT00422734|B1|Baseline|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
378021|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378022|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378107|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
378023|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378024|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378025|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378026|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378027|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378028|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378029|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378030|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
378031|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
378032|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
378033|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
378034|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
378035|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
378036|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378037|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378038|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378039|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378040|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378041|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378042|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378043|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378044|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378092|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378045|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378046|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378047|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378048|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378049|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
378050|NCT00422097|E6|Reported Event|Ixabepilone, 30 mg|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days
378051|NCT00422097|E5|Reported Event|Ixabepilone, 25 mg|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days
378052|NCT00422097|E4|Reported Event|Ixabepilone, 20 mg|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days
378053|NCT00422097|E3|Reported Event|Ixabepilone, 15 mg|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days
378054|NCT00422097|E2|Reported Event|Ixabepilone, 10 mg|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days
378055|NCT00422097|E1|Reported Event|Ixabepilone, 5 mg|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days
378056|NCT00422162|B3|Baseline|Total|Total of all reporting groups
378057|NCT00422162|B2|Baseline|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378058|NCT00422162|B1|Baseline|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378059|NCT00422162|P2|Participant Flow|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378060|NCT00422162|P1|Participant Flow|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378061|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378062|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378063|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378064|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378065|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378066|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378067|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378068|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378069|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378070|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378071|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378072|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378073|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
378074|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
378075|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
378076|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
378077|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responders|60mg BID for 8 weeks (placebo added at Week 4)
378078|NCT00422162|O3|Outcome|Duloxetine 120 mg Responders|60mg BID for 8 weeks
378079|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responders|60mg QD for 4 weeks then 60mg BID for 4 weeks
378080|NCT00422162|O1|Outcome|Duloxetine 60 mg Responders|60mg QD for 8 weeks
378081|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responders|60mg BID for 8 weeks (placebo added at Week 4)
378082|NCT00422162|O3|Outcome|Duloxetine 120 mg Responders|60mg BID for 8 weeks
378083|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responders|60mg QD for 4 weeks then 60mg BID for 4 weeks
378084|NCT00422162|O1|Outcome|Duloxetine 60 mg Responders|60mg QD for 8 weeks
378085|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378086|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378087|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378093|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
378098|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378099|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
378100|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
378101|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
378102|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
378109|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378110|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378111|NCT00422162|E2|Reported Event|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
378112|NCT00422162|E1|Reported Event|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
378113|NCT00422201|B1|Baseline|Mifepristone|"Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.
This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
378114|NCT00422201|P1|Participant Flow|Single Arm Mifepristone|"Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.
This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
378115|NCT00422201|O1|Outcome|Mifepristone|"Single arm. Study medication was administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.
This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
378116|NCT00422201|E1|Reported Event|Mifepristone|"Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.
This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
378117|NCT00422227|B3|Baseline|Total|Total of all reporting groups
378118|NCT00422227|B2|Baseline|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378119|NCT00422227|B1|Baseline|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378120|NCT00422227|P2|Participant Flow|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378121|NCT00422227|P1|Participant Flow|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378122|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378123|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378124|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378125|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378126|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378127|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378128|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378129|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378130|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378131|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378431|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
378132|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378133|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378134|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378135|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378136|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378137|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378138|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378139|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378140|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378141|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378142|NCT00422227|E2|Reported Event|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
378143|NCT00422227|E1|Reported Event|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
378144|NCT00422279|B3|Baseline|Total|Total of all reporting groups
378145|NCT00422279|B2|Baseline|Extraction Sites|bone inductive implants placed in tooth extraction sites
378146|NCT00422279|B1|Baseline|Supralveolar Position|bone inductive implants placed in supraalveolar position
378147|NCT00422279|P2|Participant Flow|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
378148|NCT00422279|P1|Participant Flow|Supraalveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
378149|NCT00422279|O2|Outcome|Extraction Sites|bone inductive implants placed in tooth extraction sockets with a total of 2 patients with 4 implants ( two implants in each patient)
378150|NCT00422279|O1|Outcome|Supraalveloar Postion|bone inductive implants placed in supraalveolar position a total of 2 patients with 4 implants ( two implants in each patient)
378151|NCT00422279|O2|Outcome|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
378152|NCT00422279|O1|Outcome|Supra Aleveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
378153|NCT00422279|E2|Reported Event|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sites
378154|NCT00422279|E1|Reported Event|Supralveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
378155|NCT00422292|B5|Baseline|Total|Total of all reporting groups
378156|NCT00422292|B4|Baseline|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378157|NCT00422292|B3|Baseline|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378158|NCT00422292|B2|Baseline|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
378159|NCT00422292|B1|Baseline|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
378160|NCT00422292|P4|Participant Flow|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378161|NCT00422292|P3|Participant Flow|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378432|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
403008|NCT00490945|E1|Reported Event|Placebo|Randomized to Placebo
378162|NCT00422292|P2|Participant Flow|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
378163|NCT00422292|P1|Participant Flow|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
378164|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378165|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378166|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
378167|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
378168|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378169|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378170|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
378171|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
378172|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378173|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378174|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
378175|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
378176|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378177|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378178|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
378179|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
378180|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378181|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378182|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
378183|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
378184|NCT00422292|E4|Reported Event|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378185|NCT00422292|E3|Reported Event|Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
378186|NCT00422292|E2|Reported Event|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
378187|NCT00422292|E1|Reported Event|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
378188|NCT00422383|B6|Baseline|Total|Total of all reporting groups
378396|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
378737|NCT00423358|B2|Baseline|Placebo|"matching placebo tablet
placebo: matching placebo"
378189|NCT00422383|B5|Baseline|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378433|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
378434|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
378435|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
403009|NCT00490971|B3|Baseline|Total|Total of all reporting groups
378190|NCT00422383|B4|Baseline|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378191|NCT00422383|B3|Baseline|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378192|NCT00422383|B2|Baseline|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378193|NCT00422383|B1|Baseline|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378194|NCT00422383|P5|Participant Flow|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378195|NCT00422383|P4|Participant Flow|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378196|NCT00422383|P3|Participant Flow|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378197|NCT00422383|P2|Participant Flow|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378198|NCT00422383|P1|Participant Flow|Rituximab Low Dose Plus (+) Methotrexate|Participants received rituximab, 0.5 grams (g), intravenously (IV), on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 milligrams (mg), IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 milligrams per milliliter (mg/mL), orally (PO) or parenterally, as prescribed. Participants also received a stable dose of folate greater than or equal to (≥) 5 milligrams per week (mg/week) given either as a single dose or as a divided weekly dose.
378199|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378397|NCT00422669|E1|Reported Event|Subjects With Implant|All 198 subjects with implant were included in this group.
378200|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378201|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378202|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378203|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378204|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378205|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378206|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378207|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378208|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378209|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378210|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378398|NCT00422695|B3|Baseline|Total|Total of all reporting groups
378399|NCT00422695|B2|Baseline|Healthy Controls|HIV -ve subjects
378400|NCT00422695|B1|Baseline|HIV +|Groups divided according to CD4 counts
378211|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378436|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
378212|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378213|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378214|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378215|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378216|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378217|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378218|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378219|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378220|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378221|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378222|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378401|NCT00422695|P2|Participant Flow|Healthy Controls|HIV -free subjects 38 Healthy Controls
378402|NCT00422695|P1|Participant Flow|HIV +|Groups divided according to CD4 counts 105 HIV subjects
378403|NCT00422695|O2|Outcome|Healthy Controls|HIV -free subjects 38 Healthy Controls
378404|NCT00422695|O1|Outcome|HIV +|Groups divided according to CD4 counts 105 HIV subjects
378223|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378224|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378225|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378226|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378227|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378228|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378229|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378230|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378231|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378232|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378233|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378234|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378405|NCT00422695|O2|Outcome|Healthy Controls|HIV -free subjects 38 Healthy Controls
378235|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378236|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378237|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378238|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378239|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378240|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378241|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378242|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378243|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378244|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378245|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378258|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378259|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378246|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378247|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378248|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378249|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378250|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378251|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378252|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378253|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378254|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378255|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378256|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378257|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378381|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
378382|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
378260|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378261|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378262|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378263|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378264|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378265|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378266|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378267|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378268|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378269|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378270|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378383|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
378384|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
378406|NCT00422695|O1|Outcome|HIV +|Groups divided according to CD4 counts 105 HIV subjects
378271|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378272|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378273|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378274|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378275|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378276|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378277|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378278|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378279|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378280|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378281|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378282|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378385|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
378386|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
378407|NCT00422695|E2|Reported Event|Healthy Controls|HIV -free subjects 38 Healthy Controls
378283|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378284|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378285|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378286|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378287|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378288|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378289|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378290|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378291|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378292|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378293|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378387|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
378388|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
378408|NCT00422695|E1|Reported Event|HIV +|Groups divided according to CD4 counts 105 HIV subjects
378342|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378294|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378295|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378296|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378297|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378298|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378299|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378300|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378301|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378302|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378303|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378304|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378305|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378389|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
378390|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
378409|NCT00422734|B3|Baseline|Total|Total of all reporting groups
378306|NCT00422383|O2|Outcome|Rituximab Escalated Dose Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378307|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378308|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378309|NCT00422383|O2|Outcome|Rituximab Escalated Dose Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378310|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378311|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378312|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378313|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378314|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378315|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378316|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378317|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378391|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
378318|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378319|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378320|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378321|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378322|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378323|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378324|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378325|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378326|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378327|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378328|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378329|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378392|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
378393|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
378410|NCT00422734|B2|Baseline|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
378330|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378331|NCT00422383|E5|Reported Event|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378332|NCT00422383|E4|Reported Event|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
378333|NCT00422383|E3|Reported Event|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378334|NCT00422383|E2|Reported Event|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378335|NCT00422383|E1|Reported Event|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
378336|NCT00422422|B1|Baseline|Brivaracetam (ES)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378337|NCT00422422|P1|Participant Flow|Brivaracetam (ES)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378338|NCT00422422|O1|Outcome|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378339|NCT00422422|O1|Outcome|Brivaracetam (FAS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378340|NCT00422422|O1|Outcome|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378341|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378394|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
378395|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
385527|NCT00438451|E1|Reported Event|Levetiracetam|Levetiracetam 250mg
378343|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378344|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378345|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378346|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378347|NCT00422422|E1|Reported Event|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:
For subjects ≥8 years:
0.4 mg/kg bid for Week 1
0.8 mg/kg bid for Week 2
1.6 mg/kg bid for Week 3
For subjects <8 years:
0.5 mg/kg bid for Week 1
1.0 mg/kg bid for Week 2
2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
0.8 mg/kg bid for Week 4
0.4 mg/kg bid for Week 5
For subjects <8 years:
1.0 mg/kg bid for Week 4
0.5 mg/kg bid for Week 5"
378348|NCT00422448|B1|Baseline|Nevi|with or without BRAF and NRAS
378349|NCT00422448|P1|Participant Flow|Nevi|with or without BRAF and NRAS
378350|NCT00422448|O1|Outcome|Nevi|with or without BRAF and NRAS
378351|NCT00422448|O1|Outcome|Nevi|with or without BRAF and NRAS
378352|NCT00422448|E1|Reported Event|Nevi|with or without BRAF and NRAS
378353|NCT00422513|B3|Baseline|Total|Total of all reporting groups
378354|NCT00422513|B2|Baseline|Epoetin Alfa|As prescribed, (iv), 3 times weekly
378355|NCT00422513|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
378356|NCT00422513|P2|Participant Flow|Epoetin Alfa|As prescribed, (iv), 3 times weekly
378357|NCT00422513|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms intravenous (iv) monthly, starting dose
378358|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
378359|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
378360|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
378361|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
378362|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
378363|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
378364|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
378365|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
378366|NCT00422513|E2|Reported Event|Epoetin Alfa|As prescribed, (iv), 3 times weekly
378367|NCT00422513|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
378368|NCT00422656|B1|Baseline|Perifosine|This is a one armed study, all participants receive daily perifosine at 150mg orally.
378369|NCT00422656|P1|Participant Flow|Perifosine|This is a one armed study, all participants receive daily perifosine at 150mg orally.
378370|NCT00422656|O1|Outcome|Perifosine Single Arm Study|Daily perifosine at 150mg orally
378371|NCT00422656|E1|Reported Event|Perifosine|This is a one armed study, all participants receive daily perifosine at 150mg orally.
378372|NCT00422669|B4|Baseline|Total|Total of all reporting groups
378373|NCT00422669|B3|Baseline|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
378374|NCT00422669|B2|Baseline|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
378375|NCT00422669|B1|Baseline|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
378376|NCT00422669|P3|Participant Flow|Not Randomized|7 of the 205 subjects did not meet inclusion/exclusion criteria.
378377|NCT00422669|P2|Participant Flow|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
378378|NCT00422669|P1|Participant Flow|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
378379|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
378380|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
385528|NCT00438464|B3|Baseline|Total|Total of all reporting groups
378412|NCT00422734|P2|Participant Flow|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
378413|NCT00422734|P1|Participant Flow|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
378414|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
378415|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
378437|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
378438|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
378439|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
378440|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
378441|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
378442|NCT00422734|E2|Reported Event|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
378443|NCT00422734|E1|Reported Event|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
378444|NCT00422903|B3|Baseline|Total|Total of all reporting groups
378445|NCT00422903|B2|Baseline|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery
378446|NCT00422903|B1|Baseline|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378447|NCT00422903|P2|Participant Flow|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378448|NCT00422903|P1|Participant Flow|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378449|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378450|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378451|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378452|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378453|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378454|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378455|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378456|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378457|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378458|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378459|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378460|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378461|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378462|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378463|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378464|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378465|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378466|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378467|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378468|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378469|NCT00422903|E2|Reported Event|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
378470|NCT00422903|E1|Reported Event|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
378471|NCT00422942|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378692|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378472|NCT00422942|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or as needed (PRN) if retreatment criteria were not met; premedication with methylprednisolone (MP) 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg per week (mg/week; oral or parenteral) for up to 48 weeks and folate (greater than or equal to [≥]5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378473|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378474|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378475|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378476|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378477|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378478|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378479|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378480|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378481|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378482|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378483|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378484|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378485|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378693|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378486|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378487|NCT00422942|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
378488|NCT00423046|B3|Baseline|Total|Total of all reporting groups
378489|NCT00423046|B2|Baseline|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378490|NCT00423046|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378491|NCT00423046|P2|Participant Flow|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378492|NCT00423046|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378493|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378494|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378495|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378496|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378497|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378498|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378499|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378500|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378570|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
378501|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378502|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378503|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378504|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378505|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378506|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378507|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378508|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378694|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378509|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378510|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378511|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378512|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378513|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378514|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378515|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378516|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378517|NCT00423046|O2|Outcome|Gardasil Group|Gardasil Group Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378518|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378519|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378520|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378521|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378522|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378523|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378524|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378525|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378526|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378527|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378528|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378529|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378530|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378531|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378532|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378533|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378534|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378535|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378536|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378537|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378538|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378539|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378540|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378541|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378542|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378543|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378544|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378545|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378546|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378547|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378548|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378549|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378550|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378551|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378552|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378553|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378554|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378555|NCT00423046|E2|Reported Event|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378556|NCT00423046|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
378557|NCT00423085|B4|Baseline|Total|Total of all reporting groups
378558|NCT00423085|B3|Baseline|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378559|NCT00423085|B2|Baseline|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378560|NCT00423085|B1|Baseline|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
378561|NCT00423085|P4|Participant Flow|Open-label Extension|"All participants started treatment with daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period). A predetermined allowed adjustment scheme was followed in patients who required dose adjustment due to low tolerability."
378562|NCT00423085|P3|Participant Flow|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378563|NCT00423085|P2|Participant Flow|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378564|NCT00423085|P1|Participant Flow|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
378565|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
378566|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
378567|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
378568|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378569|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378571|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378572|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378573|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
378574|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378575|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378576|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
378577|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378578|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378579|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
378580|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378581|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378582|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
378583|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378584|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378585|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
378586|NCT00423085|E4|Reported Event|Open-Label Extension (52 Weeks)|"All participants started treatment with daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period). A predetermined allowed adjustment scheme was followed in patients who required dose adjustment due to low tolerability."
378587|NCT00423085|E3|Reported Event|Rivastigmine 10 cm^2 (24 Weeks)|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 patch for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378617|NCT00423150|B1|Baseline|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
378739|NCT00423358|P2|Participant Flow|Placebo|"matching placebo tablet
placebo: matching placebo"
378588|NCT00423085|E2|Reported Event|Rivastigmine 5 cm^2 (24 Weeks)|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and thereafter daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
378589|NCT00423085|E1|Reported Event|Placebo (24 Weeks)|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
378590|NCT00423098|B3|Baseline|Total|Total of all reporting groups
378591|NCT00423098|B2|Baseline|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378592|NCT00423098|B1|Baseline|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378593|NCT00423098|P2|Participant Flow|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
403455|NCT00492336|E2|Reported Event|Inactive Pill|Treatment with Placebo
378594|NCT00423098|P1|Participant Flow|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378595|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378596|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378597|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378598|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378599|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378600|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378601|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378602|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378618|NCT00423150|P1|Participant Flow|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
378738|NCT00423358|B1|Baseline|Vitamin D|"ergocalciferol 50,000 IU Twice monthly
Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
378603|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378604|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378605|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378606|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378695|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378607|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378608|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378609|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378610|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378611|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378612|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378613|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378614|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378615|NCT00423098|E2|Reported Event|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378616|NCT00423098|E1|Reported Event|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
378728|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
378729|NCT00423332|O2|Outcome|Placebo|Placebo/Day
378619|NCT00423150|O1|Outcome|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
378620|NCT00423150|E1|Reported Event|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
378621|NCT00423176|B3|Baseline|Total|Total of all reporting groups
378622|NCT00423176|B2|Baseline|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
378623|NCT00423176|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
378624|NCT00423176|P2|Participant Flow|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
378625|NCT00423176|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
378626|NCT00423176|O2|Outcome|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
403456|NCT00492336|E1|Reported Event|Rasagiline|Treatment with Rasagiline
378627|NCT00423176|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
378628|NCT00423176|O2|Outcome|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
378629|NCT00423176|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
378630|NCT00423176|E2|Reported Event|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
378631|NCT00423176|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
378632|NCT00423189|B4|Baseline|Total|Total of all reporting groups
378633|NCT00423189|B3|Baseline|Arm 3|20% fluence photodynamic therapy - procedure
378634|NCT00423189|B2|Baseline|Arm 2|40% fluence photodynamic therapy - procedure
378635|NCT00423189|B1|Baseline|Arm 1|drug - intravitreal ranibizumab
378636|NCT00423189|P3|Participant Flow|Ranibizumab and 20% Fluence PDT(Procedure)|20% fluence photodynamic therapy - procedure
378637|NCT00423189|P2|Participant Flow|Ranibizumab and 40% Fluence PDT(Procedure)|40% fluence photodynamic therapy - procedure
378638|NCT00423189|P1|Participant Flow|Ranibizumab Only|drug - intravitreal ranibizumab
378639|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab - procedure
378640|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy/combined with ranibizumab - procedure
378641|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
378642|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
378643|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
378644|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
378645|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
378646|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
378647|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
378648|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
378649|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
378650|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
378651|NCT00423189|O3|Outcome|20% Fluence PDT/Ranibizumab|20% Fluence PDT with IVT Ranibizumab
378652|NCT00423189|O2|Outcome|40% Fluence PDT/Ranibizumab|40% Fluence PDT WITH ivt Ranibizumab
378653|NCT00423189|O1|Outcome|Ranibizumab Only|IVT Ranibizumab only
378654|NCT00423189|E3|Reported Event|20% PDT Fluence Combined With Ranibizumab|Subjects who received 20% with as needed ranibizumab
378655|NCT00423189|E2|Reported Event|40% Fluence PDT Combined With Ranibizumab|Subjects who have received 40% fluence PDT combined with as needed dosing with ranibizumab
378656|NCT00423189|E1|Reported Event|Ranibizumab Only|subject only received ranibizumab
378657|NCT00423267|B3|Baseline|Total|Total of all reporting groups
378658|NCT00423267|B2|Baseline|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
378730|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
378659|NCT00423267|B1|Baseline|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
378660|NCT00423267|P2|Participant Flow|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
378661|NCT00423267|P1|Participant Flow|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months. One subject from period A declined to participate in the amended protocol and discontinued study treatment after 12 months of study drug administration.
378662|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
378696|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378663|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
378664|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
378665|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
378666|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
378667|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
378668|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
378669|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
378670|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
378671|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
378672|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
378673|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
378674|NCT00423267|E3|Reported Event|Posaconazole Period B|
378675|NCT00423267|E2|Reported Event|Fluconazole Period A|
378676|NCT00423267|E1|Reported Event|Posaconazole Period A|
378677|NCT00423293|B1|Baseline|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
378678|NCT00423293|P1|Participant Flow|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
378679|NCT00423293|O1|Outcome|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
378680|NCT00423293|E1|Reported Event|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
378681|NCT00423319|B3|Baseline|Total|Total of all reporting groups
378682|NCT00423319|B2|Baseline|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378731|NCT00423332|O2|Outcome|Placebo|Placebo/Day
378732|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
378683|NCT00423319|B1|Baseline|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378684|NCT00423319|P2|Participant Flow|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378685|NCT00423319|P1|Participant Flow|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378686|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378687|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378688|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378689|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378690|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378691|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378697|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378698|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378699|NCT00423319|O1|Outcome|Apixiban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378700|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378701|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378702|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378703|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378704|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378705|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378706|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378707|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378708|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378709|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378710|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378711|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378712|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378713|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378714|NCT00423319|E2|Reported Event|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
378715|NCT00423319|E1|Reported Event|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
378716|NCT00423332|B3|Baseline|Total|Total of all reporting groups
378717|NCT00423332|B2|Baseline|Placebo|Placebo/Day
378718|NCT00423332|B1|Baseline|AZD2171 45 mg|AZD2171 45mg/Day
378719|NCT00423332|P2|Participant Flow|Placebo|Placebo / Day: 18 patients randomised
378720|NCT00423332|P1|Participant Flow|AZD2171 45 mg|AZD2171 45mg/Day: 53 patients randomised
378721|NCT00423332|O2|Outcome|Placebo|Placebo/Day
378722|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
378723|NCT00423332|O2|Outcome|Placebo|Placebo/Day
378724|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
378725|NCT00423332|O2|Outcome|Placebo|Placebo/Day
378726|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
378727|NCT00423332|O2|Outcome|Placebo|Placebo/Day
378740|NCT00423358|P1|Participant Flow|Vitamin D|"ergocalciferol 50,000 IU Twice monthly
Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
378741|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet
placebo: matching placebo"
378742|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly
Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
378743|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet
placebo: matching placebo"
378744|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly
Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
378745|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet
placebo: matching placebo"
378746|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly
Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
378747|NCT00423358|E2|Reported Event|Placebo, n=11|"matching placebo tablet
placebo: matching placebo"
378748|NCT00423358|E1|Reported Event|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly
Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
378749|NCT00423436|B3|Baseline|Total|Total of all reporting groups
378750|NCT00423436|B2|Baseline|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
378751|NCT00423436|B1|Baseline|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
378752|NCT00423436|P2|Participant Flow|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
378753|NCT00423436|P1|Participant Flow|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
378754|NCT00423436|O2|Outcome|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
378755|NCT00423436|O1|Outcome|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
378756|NCT00423436|E2|Reported Event|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
403493|NCT00492557|B3|Baseline|Total|Total of all reporting groups
378757|NCT00423436|E1|Reported Event|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
378758|NCT00423449|B1|Baseline|All Participants|Vorinostat + Gemcitabine + Cisplatin
378759|NCT00423449|P5|Participant Flow|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378760|NCT00423449|P4|Participant Flow|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378761|NCT00423449|P3|Participant Flow|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378762|NCT00423449|P2|Participant Flow|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378763|NCT00423449|P1|Participant Flow|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378764|NCT00423449|O1|Outcome|All Participants|Vorinostat + Gemcitabine + Cisplatin
378765|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378766|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378767|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378768|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378769|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378770|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378771|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378772|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378773|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378774|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378932|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378775|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378776|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378777|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378778|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378779|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
378780|NCT00423449|E5|Reported Event|MK-0683 400 mg 14d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
378781|NCT00423449|E4|Reported Event|MK-0683 400 mg 10d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
378782|NCT00423449|E3|Reported Event|MK-0683 400 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
378783|NCT00423449|E2|Reported Event|MK-0683 300 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
378784|NCT00423449|E1|Reported Event|MK-0683 300 mg x 7d/21d + Gemcitabine 1000 mg/m^2 + Cisplatin|
378785|NCT00423488|B3|Baseline|Total|Total of all reporting groups
378786|NCT00423488|B2|Baseline|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
378787|NCT00423488|B1|Baseline|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
378788|NCT00423488|P2|Participant Flow|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
378789|NCT00423488|P1|Participant Flow|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
378790|NCT00423488|O2|Outcome|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
378791|NCT00423488|O1|Outcome|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
378792|NCT00423488|E2|Reported Event|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
378793|NCT00423488|E1|Reported Event|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
378794|NCT00423579|B3|Baseline|Total|Total of all reporting groups
378795|NCT00423579|B2|Baseline|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
378796|NCT00423579|B1|Baseline|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
378797|NCT00423579|P2|Participant Flow|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
378798|NCT00423579|P1|Participant Flow|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
378799|NCT00423579|O2|Outcome|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
378800|NCT00423579|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
378801|NCT00423579|E2|Reported Event|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
378802|NCT00423579|E1|Reported Event|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
378803|NCT00423592|B1|Baseline|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
379237|NCT00429923|O1|Outcome|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
378804|NCT00423592|P1|Participant Flow|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378805|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378806|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378807|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378808|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378809|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378810|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378811|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
379735|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
378812|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378813|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378814|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378815|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378816|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378817|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378818|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378819|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378820|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378821|NCT00423592|E1|Reported Event|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
378822|NCT00423605|B1|Baseline|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
378823|NCT00423605|P1|Participant Flow|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
378824|NCT00423605|O1|Outcome|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
378825|NCT00423605|E1|Reported Event|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
378826|NCT00423657|B3|Baseline|Total|Total of all reporting groups
378827|NCT00423657|B2|Baseline|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
378828|NCT00423657|B1|Baseline|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
378829|NCT00423657|P2|Participant Flow|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
378830|NCT00423657|P1|Participant Flow|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
386445|NCT00449865|O1|Outcome|Placebo|placebo: an inactive substance
378831|NCT00423657|O2|Outcome|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
378832|NCT00423657|O1|Outcome|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
378833|NCT00423657|E2|Reported Event|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
378834|NCT00423657|E1|Reported Event|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
378835|NCT00423670|B8|Baseline|Total|Total of all reporting groups
378836|NCT00423670|B7|Baseline|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378837|NCT00423670|B6|Baseline|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378838|NCT00423670|B5|Baseline|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
378839|NCT00423670|B4|Baseline|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
378840|NCT00423670|B3|Baseline|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
378841|NCT00423670|B2|Baseline|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
378898|NCT00423670|E7|Reported Event|PEG +Low-dose RBV + BOC for 48 Wks (Part II)|Arm 7. PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378842|NCT00423670|B1|Baseline|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
378843|NCT00423670|P8|Participant Flow|Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)|Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
378844|NCT00423670|P7|Participant Flow|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378845|NCT00423670|P6|Participant Flow|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378846|NCT00423670|P5|Participant Flow|Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
378847|NCT00423670|P4|Participant Flow|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
378848|NCT00423670|P3|Participant Flow|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
378849|NCT00423670|P2|Participant Flow|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
378850|NCT00423670|P1|Participant Flow|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks."
378851|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378852|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378853|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
378854|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
378855|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
378856|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
378857|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
378858|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378859|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378890|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378860|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
378861|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
378862|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
378863|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
378864|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
378865|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378866|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378867|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
378868|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
379419|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
378869|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
378870|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
378871|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
378872|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378873|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378874|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
378875|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
378876|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
378877|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
378878|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
378879|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378880|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378881|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
378882|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
378883|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
378884|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
378885|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
378886|NCT00423670|O2|Outcome|Arm 2 and Arm 3. PEG + RBV + BOC (28 Weeks)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 28 weeks.
378887|NCT00423670|O1|Outcome|Arm 4 and Arm 5. PEG + RBV + BOC (48 Weeks)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 48 weeks.
378888|NCT00423670|O2|Outcome|Arm 2 and Arm 4. PEG + RBV + BOC|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
378889|NCT00423670|O1|Outcome|Arm 3 and Arm 5. PEG + RBV + BOC (From Wk 4)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
378891|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378892|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
378893|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
378894|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
378895|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
378896|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
378897|NCT00423670|E8|Reported Event|PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)|Arm 8. Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
379420|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
378899|NCT00423670|E6|Reported Event|PEG + RBV + BOC for 48 Wks (Part II)|Arm 6. PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
378900|NCT00423670|E5|Reported Event|PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)|Arm 5. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
378901|NCT00423670|E4|Reported Event|PEG +RBV + BOC for 48 Wks (Part I)|Arm 4. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
378902|NCT00423670|E3|Reported Event|PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|Arm 3. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
378903|NCT00423670|E2|Reported Event|PEG + RBV + BOC for 28 Wks (Part I)|Arm 2. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
378904|NCT00423670|E1|Reported Event|PEG +RBV for 48 Wks (Part I)|"Arm 1. PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks.
Adverse events for 36 participants after they crossed over to Arm 8 are not included."
378905|NCT00423683|B3|Baseline|Total|Total of all reporting groups
378906|NCT00423683|B2|Baseline|1- Arixtra Alone|Arixtra treatment without inferior vena cava filter
378907|NCT00423683|B1|Baseline|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
378908|NCT00423683|P2|Participant Flow|1-Arixtra Alone|Arixtra treatment without inferior vena cava filter
378909|NCT00423683|P1|Participant Flow|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
378910|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
378911|NCT00423683|O1|Outcome|Arm 1 Arixtra|
378912|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
378913|NCT00423683|O1|Outcome|Arm 1 Arixtra|
378914|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
378915|NCT00423683|O1|Outcome|Arm 1 Arixtra|
378916|NCT00423683|O2|Outcome|Arixtra and Filter|
378917|NCT00423683|O1|Outcome|Arixtra|
378918|NCT00423683|E2|Reported Event|Arixtra Alone|Arixtra anti coagulation alone
378919|NCT00423683|E1|Reported Event|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
378920|NCT00423722|B3|Baseline|Total|Total of all reporting groups
378921|NCT00423722|B2|Baseline|Placebo: Lower Saline|Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378922|NCT00423722|B1|Baseline|Hydration: Normal Saline (Salt Water)|Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378923|NCT00423722|P2|Participant Flow|Placebo: Lower Saline|Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378924|NCT00423722|P1|Participant Flow|Hydration: Normal Saline (Salt Water)|Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378925|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378926|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378927|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378928|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378929|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378930|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378931|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
386446|NCT00449865|E2|Reported Event|Creatine|creatine 5 grams twice daily
378933|NCT00423722|O2|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378934|NCT00423722|O1|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378935|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378936|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378937|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378938|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378939|NCT00423722|O2|Outcome|Placebo|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378940|NCT00423722|O1|Outcome|Hydration|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
378941|NCT00423722|E2|Reported Event|Placebo|Change Between Day 4 and Baseline
378942|NCT00423722|E1|Reported Event|Hydration|Change Between Day 4 and Baseline
378943|NCT00423735|B4|Baseline|Total|Total of all reporting groups
378944|NCT00423735|B3|Baseline|Stage 2: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
379196|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
378945|NCT00423735|B2|Baseline|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
378946|NCT00423735|B1|Baseline|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
378947|NCT00423735|P3|Participant Flow|Stage 2: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
378948|NCT00423735|P2|Participant Flow|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
378949|NCT00423735|P1|Participant Flow|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
378950|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
378951|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
378952|NCT00423735|O2|Outcome|Progressive Disease|"Patients with best tumor response of progressive disease by six months. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased."
378953|NCT00423735|O1|Outcome|Stable Disease|"Patients with best response of stable disease by six months. Stable disease (SD): Does not qualify for CR, PR, or PD. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased."
378954|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
378955|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
378956|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
378957|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
378958|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
378959|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
378960|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
378961|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
379238|NCT00429949|B1|Baseline|Dasatinib|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
378962|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
378963|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
378964|NCT00423735|O3|Outcome|Stage 2:|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity
378965|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
378966|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
378967|NCT00423735|E2|Reported Event|Stage 1B: Dasatinib up to 400mg/Day|"Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
dasatinib: Given orally"
379556|NCT00432237|B5|Baseline|Total|Total of all reporting groups
378968|NCT00423735|E1|Reported Event|Stage 1: Dasatinib 200mg/Day|"Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
dasatinib: Given orally"
378969|NCT00423800|B3|Baseline|Total|Total of all reporting groups
378970|NCT00423800|B2|Baseline|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
378971|NCT00423800|B1|Baseline|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
378972|NCT00423800|P2|Participant Flow|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
378973|NCT00423800|P1|Participant Flow|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
378974|NCT00423800|O2|Outcome|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
378975|NCT00423800|O1|Outcome|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
378976|NCT00423800|O2|Outcome|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
378977|NCT00423800|O1|Outcome|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
378978|NCT00423800|E3|Reported Event|Pegetron® - 48 Weeks|Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 40 weeks of treatment.
378979|NCT00423800|E2|Reported Event|Pegetron® - 24 Weeks|Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 16 weeks of treatment.
378980|NCT00423800|E1|Reported Event|Screen Failures|Two participants on commercial Pegetron® who were screen fails and were never randomized had SAEs. Both SAEs were are reported here.
378981|NCT00423813|B4|Baseline|Total|Total of all reporting groups
378982|NCT00423813|B3|Baseline|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
378983|NCT00423813|B2|Baseline|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
378984|NCT00423813|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
378985|NCT00423813|P3|Participant Flow|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
378986|NCT00423813|P2|Participant Flow|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
378987|NCT00423813|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
378988|NCT00423813|O3|Outcome|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
378989|NCT00423813|O2|Outcome|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
378990|NCT00423813|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
378991|NCT00423813|E3|Reported Event|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
378992|NCT00423813|E2|Reported Event|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
378993|NCT00423813|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
378994|NCT00423852|B1|Baseline|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.
filgrastim
carboplatin
ifosfamide
paclitaxel
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
378995|NCT00423852|P1|Participant Flow|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.
filgrastim
carboplatin
ifosfamide
paclitaxel
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
379239|NCT00429949|P1|Participant Flow|Dasatinib|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
380159|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
378996|NCT00423852|O1|Outcome|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.
filgrastim
carboplatin
ifosfamide
paclitaxel
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
378997|NCT00423852|O1|Outcome|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.
filgrastim
carboplatin
ifosfamide
paclitaxel
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
379018|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
378998|NCT00423852|E1|Reported Event|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.
filgrastim
carboplatin
ifosfamide
paclitaxel
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
378999|NCT00423878|B3|Baseline|Total|Total of all reporting groups
379000|NCT00423878|B2|Baseline|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
379001|NCT00423878|B1|Baseline|Switch Group|Participants will switch to aripiprazole.
379002|NCT00423878|P2|Participant Flow|Stay Group|Participants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day.
379003|NCT00423878|P1|Participant Flow|Switch Group|Participants will switch to aripiprazole with a cross-titration from the current antipsychotic over 3-4 weeks. Allowed final dosage range for aripiprazole was 5-30 mg/day.
379004|NCT00423878|O2|Outcome|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
379005|NCT00423878|O1|Outcome|Switch Group|Participants will switch to aripiprazole.
379006|NCT00423878|O2|Outcome|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
379007|NCT00423878|O1|Outcome|Switch Group|Participants will switch to aripiprazole.
379008|NCT00423878|E2|Reported Event|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
379009|NCT00423878|E1|Reported Event|Switch Group|Participants will switch to aripiprazole.
379010|NCT00423891|B4|Baseline|Total|Total of all reporting groups
379011|NCT00423891|B3|Baseline|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379012|NCT00423891|B2|Baseline|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379013|NCT00423891|B1|Baseline|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379014|NCT00423891|P3|Participant Flow|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379015|NCT00423891|P2|Participant Flow|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379119|NCT00424021|P3|Participant Flow|5 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379982|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379016|NCT00423891|P1|Participant Flow|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379017|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379019|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379020|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379021|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379022|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379023|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379024|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379025|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379026|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379120|NCT00424021|P2|Participant Flow|2.5 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
379027|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379028|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379029|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379726|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
379030|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379031|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379032|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379033|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379034|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379035|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379036|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379037|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379121|NCT00424021|P1|Participant Flow|1 mg|The optimized final dose from the open-label period of AMB 220 (given once daily [QD] by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
379038|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379039|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379040|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379041|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379042|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379043|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379044|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379045|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379046|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379047|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379048|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379122|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379049|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379050|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379051|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379052|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379053|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379054|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379055|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379056|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379057|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379058|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379059|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379240|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
379060|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379061|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379062|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379063|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379064|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379065|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379066|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379067|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379068|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379069|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379070|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379278|NCT00431626|E2|Reported Event|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
379983|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
379071|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379072|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379092|NCT00423930|B1|Baseline|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.
bevacizumab
cisplatin
conventional surgery
intensity-modulated radiation therapy"
379197|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
379073|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379074|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379075|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379076|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379077|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379078|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379079|NCT00423891|E3|Reported Event|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
379080|NCT00423891|E2|Reported Event|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379123|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379124|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
380264|NCT00433654|B3|Baseline|Total|Total of all reporting groups
379081|NCT00423891|E1|Reported Event|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
379093|NCT00423930|P1|Participant Flow|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.
bevacizumab
cisplatin
conventional surgery
intensity-modulated radiation therapy"
379198|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
379082|NCT00423917|B1|Baseline|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
379083|NCT00423917|P1|Participant Flow|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
379084|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
379085|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
379086|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
379087|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
379088|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
379089|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
379090|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
379279|NCT00431626|E1|Reported Event|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient
Dutasteride (Avodart)"
379091|NCT00423917|E1|Reported Event|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
379094|NCT00423930|O1|Outcome|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.
bevacizumab
cisplatin
conventional surgery
intensity-modulated radiation therapy"
379095|NCT00423930|O1|Outcome|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.
bevacizumab
cisplatin
conventional surgery
intensity-modulated radiation therapy"
379096|NCT00423930|E1|Reported Event|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.
bevacizumab
cisplatin
conventional surgery
intensity-modulated radiation therapy"
379097|NCT00424008|B3|Baseline|Total|Total of all reporting groups
379098|NCT00424008|B2|Baseline|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
379099|NCT00424008|B1|Baseline|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
379100|NCT00424008|P2|Participant Flow|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
379101|NCT00424008|P1|Participant Flow|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
379102|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
379103|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
379104|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
379105|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
379106|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
379107|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
379108|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
379109|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
379110|NCT00424008|E3|Reported Event|F/SC DPI * 250/50 MCG BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
379111|NCT00424008|E2|Reported Event|MF/F MDI * 200/10 MCG * BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
379112|NCT00424008|E1|Reported Event|Open-label (OL) MF MDI * 200 MCG BID|Mometasone furoate 200 mcg taken twice daily (BID) via a metered-dose inhaler (MDI).
379113|NCT00424021|B5|Baseline|Total|Total of all reporting groups
379114|NCT00424021|B4|Baseline|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379115|NCT00424021|B3|Baseline|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379116|NCT00424021|B2|Baseline|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
379117|NCT00424021|B1|Baseline|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
379118|NCT00424021|P4|Participant Flow|10 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379125|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
379126|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379127|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379128|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
379129|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
379162|NCT00424047|B2|Baseline|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
379130|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379131|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379132|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379133|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379134|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379135|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379136|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379137|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
379138|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379139|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379140|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379141|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379280|NCT00431834|B1|Baseline|Entire Cohort|All subjects enrolled and treated with the Cardioblate Surgical Ablation System
389566|NCT00455702|P1|Participant Flow|D-cycloserine|50 mg d-cycloserine
379142|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
379143|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379194|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
379144|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379145|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379146|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379147|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
379148|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379149|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379150|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379151|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
379152|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
379153|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379154|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379155|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
379156|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
379157|NCT00424021|E4|Reported Event|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379232|NCT00429923|P3|Participant Flow|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
379158|NCT00424021|E3|Reported Event|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
379159|NCT00424021|E2|Reported Event|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
379160|NCT00424021|E1|Reported Event|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
379161|NCT00424047|B3|Baseline|Total|Total of all reporting groups
379727|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
379163|NCT00424047|B1|Baseline|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379164|NCT00424047|P2|Participant Flow|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.
Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.
Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.
After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
379165|NCT00424047|P1|Participant Flow|Lenalidomide Plus Dexamethasone (Len/Dex)|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379166|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.
After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
379167|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379168|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.
After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
379169|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379170|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
379171|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379172|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.
Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
379173|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379174|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
379233|NCT00429923|P2|Participant Flow|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
379234|NCT00429923|P1|Participant Flow|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
379175|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379176|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
379177|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379195|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
379178|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.
After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
379179|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379180|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.
Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.
After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
379181|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379182|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.
Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
379183|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379184|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.
Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.
After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
379185|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379186|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.
Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
379187|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379188|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.
Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
379189|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379190|NCT00424047|E2|Reported Event|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
379235|NCT00429923|O3|Outcome|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
379236|NCT00429923|O2|Outcome|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
379191|NCT00424047|E1|Reported Event|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.
Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
379192|NCT00424177|B1|Baseline|Overall Study Population|Male and female participants greater than or equal to 18 years of age with previously treated chronic ITP, as defined according to the American Society of Hematology/British Committee for Standards in Hematology guidelines, who had platelet counts between greater than or equal to 20 gi/L and less than or equal to 50 Gi/L, on the Day 1 visit (or within 24 hours prior to dosing on Day 1).
379193|NCT00424177|P1|Participant Flow|Treatment Period|Three cycles of treatment. A cycle is defined as an on-therapy period of up to 6 weeks and an off-therapy period of up to 4 weeks.
379728|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
379199|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
379200|NCT00424177|O1|Outcome|Overall Study|
379201|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
379202|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
379203|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
379204|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
379205|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
379206|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
379207|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
379208|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
379209|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
379210|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
379211|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
379212|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
379213|NCT00424177|E6|Reported Event|All Cycles|Participants who reported an AE anytime during 3 cycles of treatment. A cycle consisted of once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy.
379214|NCT00424177|E5|Reported Event|More Than 30 Days After Last Dose|Adverse events >30 days after last dose (Post-therapy)
379215|NCT00424177|E4|Reported Event|More Than 1 to 30 Days After Last Dose|Adverse events >1 to 30 days after last dose (Post-therapy)
379216|NCT00424177|E3|Reported Event|Cycle 3|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
379217|NCT00424177|E2|Reported Event|Cycle 2|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
379218|NCT00424177|E1|Reported Event|Cycle 1|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
379219|NCT00424190|B3|Baseline|Total|Total of all reporting groups
379220|NCT00424190|B2|Baseline|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
379221|NCT00424190|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
379222|NCT00424190|P2|Participant Flow|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
379223|NCT00424190|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
379224|NCT00424190|O2|Outcome|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
379225|NCT00424190|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
379226|NCT00424190|E2|Reported Event|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
379227|NCT00424190|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
379228|NCT00429923|B4|Baseline|Total|Total of all reporting groups
379229|NCT00429923|B3|Baseline|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
379230|NCT00429923|B2|Baseline|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
379231|NCT00429923|B1|Baseline|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
379241|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
379242|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
379243|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
379244|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
379245|NCT00429949|O2|Outcome|Dasatinib 100 mg BID|In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
379246|NCT00429949|O1|Outcome|Dasatinib 70 mg BID|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
379247|NCT00429949|E1|Reported Event|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
379248|NCT00430027|B1|Baseline|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
379249|NCT00430027|P1|Participant Flow|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
379250|NCT00430027|O1|Outcome|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
379251|NCT00430027|E1|Reported Event|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
379252|NCT00430092|B4|Baseline|Total|Total of all reporting groups
379253|NCT00430092|B3|Baseline|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
379254|NCT00430092|B2|Baseline|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
379255|NCT00430092|B1|Baseline|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
379256|NCT00430092|P3|Participant Flow|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
379257|NCT00430092|P2|Participant Flow|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
379258|NCT00430092|P1|Participant Flow|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
379259|NCT00430092|O3|Outcome|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
379260|NCT00430092|O2|Outcome|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
379261|NCT00430092|O1|Outcome|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
379262|NCT00431496|B1|Baseline|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
379263|NCT00431496|P1|Participant Flow|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was > 31.8 pmol/L (300 pg/mL), unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was < 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase.
379264|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
379265|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
379266|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
379267|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
379268|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
379269|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
379270|NCT00431496|E1|Reported Event|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
379271|NCT00431626|B3|Baseline|Total|Total of all reporting groups
379272|NCT00431626|B2|Baseline|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
379273|NCT00431626|B1|Baseline|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient
Dutasteride (Avodart)"
379274|NCT00431626|P2|Participant Flow|Placebo|
379275|NCT00431626|P1|Participant Flow|Treatment|
379276|NCT00431626|O2|Outcome|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
379277|NCT00431626|O1|Outcome|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient
Dutasteride (Avodart)"
379281|NCT00431834|P1|Participant Flow|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 3 subjects died, 7 subjects withdrew from the study, 2 subjects missed the endpoint visit, and 1 subject was lost to follow-up.
379282|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|
379283|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects who were enrolled and were treated with the Cardioblate surgical ablation system with at least 6-month post-operative follow-up or an MAE prior to the end of the 6th month window were included in the analysis.
379284|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who completed 6 month follow-up and had a 24-hour Holter assessment.
379285|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who completed a Holter assessment at 6 month follow-up.
379286|NCT00431834|E1|Reported Event|Study Completion Cohort|75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 4 subjects died, 8 subjects withdrew from the study, and 1 subject was lost to follow-up.
379287|NCT00431847|B5|Baseline|Total|Total of all reporting groups
379288|NCT00431847|B4|Baseline|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379289|NCT00431847|B3|Baseline|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379290|NCT00431847|B2|Baseline|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379291|NCT00431847|B1|Baseline|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379292|NCT00431847|P5|Participant Flow|Unknown Treatment Status|No patient data on exposure to Regional Anesthesia
379293|NCT00431847|P4|Participant Flow|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379294|NCT00431847|P3|Participant Flow|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379295|NCT00431847|P2|Participant Flow|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379296|NCT00431847|P1|Participant Flow|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379297|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379298|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379299|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379300|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379301|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379302|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379303|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379304|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379305|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379306|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379307|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379308|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379309|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379310|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379408|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379311|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379312|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379313|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379314|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379315|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379316|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379317|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379729|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
379318|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379319|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379320|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379321|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379322|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379323|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379324|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379325|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379326|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379327|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379328|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379329|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379330|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379331|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379332|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379333|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379334|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379335|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379336|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379337|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379338|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379409|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379339|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379340|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379341|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379342|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379343|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379344|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379345|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379346|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379347|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379348|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379349|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379350|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379351|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379352|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379353|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379354|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379355|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379356|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379357|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379358|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379359|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379360|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379361|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379362|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
379363|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379364|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379365|NCT00431847|E4|Reported Event|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
379366|NCT00431847|E3|Reported Event|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
380265|NCT00433654|B2|Baseline|Control Group|The control group waited for one hour (did not have an MRI scan) at 9-12 weeks post-implant.
379367|NCT00431847|E2|Reported Event|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
379368|NCT00431847|E1|Reported Event|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
379369|NCT00431951|B5|Baseline|Total|Total of all reporting groups
379370|NCT00431951|B4|Baseline|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
379371|NCT00431951|B3|Baseline|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379372|NCT00431951|B2|Baseline|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379373|NCT00431951|B1|Baseline|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379374|NCT00431951|P4|Participant Flow|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
379730|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
379375|NCT00431951|P3|Participant Flow|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379376|NCT00431951|P2|Participant Flow|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379377|NCT00431951|P1|Participant Flow|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379378|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
379379|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379380|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379381|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379382|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
379383|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379384|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379385|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379386|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
379387|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379388|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379389|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379390|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
379391|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379392|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379393|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379394|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
379395|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379396|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379397|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379398|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
379399|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379400|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379401|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379402|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
379403|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379404|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379405|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379406|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
379407|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
390066|NCT00450723|O1|Outcome|Sentinel Lymph Node Biopsy|
379410|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
379411|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379412|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379413|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379414|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
379415|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379416|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379417|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379418|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
379736|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
379421|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379422|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
379423|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379424|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379425|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379426|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
379427|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379428|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379429|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379430|NCT00431951|E4|Reported Event|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
379431|NCT00431951|E3|Reported Event|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379432|NCT00431951|E2|Reported Event|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
379433|NCT00431951|E1|Reported Event|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
379434|NCT00431964|B3|Baseline|Total|Total of all reporting groups
379435|NCT00431964|B2|Baseline|Placebo|"placebo tablets (matched to active drug in appearance)
placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs
*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
379436|NCT00431964|B1|Baseline|Active|"azithromycin 250 mg tablets
azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs
*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
379437|NCT00431964|P2|Participant Flow|Placebo|"placebo tablets (matched to active drug in appearance)
placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs
*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
379438|NCT00431964|P1|Participant Flow|Active|"azithromycin 250 mg tablets
azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs
*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
379439|NCT00431964|O2|Outcome|Placebo|"placebo tablets (matched to active drug in appearance)
placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs
*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
379440|NCT00431964|O1|Outcome|Active|"azithromycin 250 mg tablets
azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs
*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
379441|NCT00431964|E2|Reported Event|Placebo|"placebo tablets (matched to active drug in appearance)
placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs
*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
379442|NCT00431964|E1|Reported Event|Active|"azithromycin 250 mg tablets
azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs
*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
379443|NCT00432159|B6|Baseline|Total|Total of all reporting groups
379444|NCT00432159|B5|Baseline|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379445|NCT00432159|B4|Baseline|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379984|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379446|NCT00432159|B3|Baseline|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379447|NCT00432159|B2|Baseline|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379448|NCT00432159|B1|Baseline|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379449|NCT00432159|P5|Participant Flow|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379450|NCT00432159|P4|Participant Flow|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379731|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
379451|NCT00432159|P3|Participant Flow|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379452|NCT00432159|P2|Participant Flow|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379453|NCT00432159|P1|Participant Flow|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379454|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379455|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379456|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379457|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379458|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379459|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379460|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379461|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379462|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379463|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379464|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379465|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379466|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379985|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379467|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379468|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379469|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379470|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379471|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379472|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379473|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379474|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379475|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379476|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379477|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379478|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379479|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379480|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379481|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379482|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379483|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379484|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379485|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379486|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379487|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379584|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
379488|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379489|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379490|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379491|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379492|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379493|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379494|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379495|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379496|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379497|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379498|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379499|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379500|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379501|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379502|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379503|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379504|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379505|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379506|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379507|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379508|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379582|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
379509|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379510|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379511|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379512|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379513|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379514|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379515|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379516|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379517|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379518|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379519|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379520|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379521|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379522|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379523|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379524|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379525|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379526|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379527|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379528|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379529|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379976|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379530|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379531|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379532|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379533|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379534|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379535|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379536|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379537|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379538|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379539|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379540|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379541|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379542|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379543|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379544|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379545|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379546|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379547|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379548|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379549|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379550|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379583|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
379551|NCT00432159|E5|Reported Event|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379552|NCT00432159|E4|Reported Event|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379553|NCT00432159|E3|Reported Event|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379554|NCT00432159|E2|Reported Event|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
379555|NCT00432159|E1|Reported Event|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
379557|NCT00432237|B4|Baseline|Placebo|"Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
The reported number of participants are all patients randomized who received study drug and completed the study."
379558|NCT00432237|B3|Baseline|MK0974 300 mg|"MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
The reported number of participants are all patients randomized who received study drug and completed the study."
379559|NCT00432237|B2|Baseline|MK0974 150 mg|"MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
The reported number of participants are all patients randomized who received study drug and completed the study."
379560|NCT00432237|B1|Baseline|MK0974 50 mg|"MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
The reported number of participants are all patients randomized who received study drug and completed the study."
379561|NCT00432237|P4|Participant Flow|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
379562|NCT00432237|P3|Participant Flow|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
379563|NCT00432237|P2|Participant Flow|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
379564|NCT00432237|P1|Participant Flow|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
379565|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
379566|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
379567|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
379568|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
379569|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
379570|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
379571|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
379572|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
379573|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
379574|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
379575|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
379576|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
379577|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
379578|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
379579|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
379580|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
379581|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
379977|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
390067|NCT00450723|O1|Outcome|Sentinel Lymph Node Biopsy|
379585|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
379586|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
379587|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
379588|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
379589|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
379590|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
379591|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
379592|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
379593|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
379594|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
379595|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
379596|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
379597|NCT00432237|E4|Reported Event|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
379598|NCT00432237|E3|Reported Event|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
379599|NCT00432237|E2|Reported Event|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
379600|NCT00432237|E1|Reported Event|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
379601|NCT00432276|B3|Baseline|Total|Total of all reporting groups
379602|NCT00432276|B2|Baseline|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379603|NCT00432276|B1|Baseline|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379604|NCT00432276|P2|Participant Flow|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379605|NCT00432276|P1|Participant Flow|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379606|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379607|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379608|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379609|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379610|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379611|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379612|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379613|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379614|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379615|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379616|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379978|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379617|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379618|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379619|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379620|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379621|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379622|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379732|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
379733|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
379623|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379624|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379625|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379626|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379627|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379628|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379629|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379630|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379631|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379632|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379633|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379634|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379635|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379636|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379637|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379638|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379639|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379640|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379641|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379642|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379643|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379644|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
390068|NCT00450723|E1|Reported Event|Single Arm|
379645|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379646|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379647|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379648|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379649|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379650|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379651|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379652|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379653|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379654|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379655|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379656|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379657|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379658|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379659|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379660|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379661|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379662|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379663|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379664|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379665|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379666|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379667|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379668|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379669|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379670|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379671|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379672|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
390069|NCT00450749|B4|Baseline|Total|Total of all reporting groups
379673|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379674|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379675|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379676|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379677|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379678|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379679|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379680|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379681|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379682|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379683|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379684|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379685|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379686|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379687|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379688|NCT00432276|E2|Reported Event|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379689|NCT00432276|E1|Reported Event|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
379690|NCT00432341|B3|Baseline|Total|Total of all reporting groups
379691|NCT00432341|B2|Baseline|Dysport®|Botulinum toxin type A (Dysport®)
379692|NCT00432341|B1|Baseline|BOTOX®|Botulinum toxin type A (BOTOX®)
379693|NCT00432341|P2|Participant Flow|Dysport®|Botulinum toxin type A (Dysport®)
379694|NCT00432341|P1|Participant Flow|BOTOX®|Botulinum toxin type A (BOTOX®)
379695|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
379696|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
379697|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
379698|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
379699|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
379700|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
379701|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
379702|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
379703|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
379704|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
379705|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
379706|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
379707|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
379708|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
379709|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
379710|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
379711|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
379712|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
379713|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
379714|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
379715|NCT00432341|E2|Reported Event|Dysport®|Botulinum toxin type A (Dysport®)
379716|NCT00432341|E1|Reported Event|BOTOX®|Botulinum toxin type A (BOTOX®)
379717|NCT00432445|B1|Baseline|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
390901|NCT00460239|O1|Outcome|Placebo 0 mg|
379718|NCT00432445|P1|Participant Flow|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
379719|NCT00432445|O1|Outcome|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
379720|NCT00432445|E1|Reported Event|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
379721|NCT00432458|B3|Baseline|Total|Total of all reporting groups
379722|NCT00432458|B2|Baseline|Arm II: ZLD|Zoledronic acid (ZLD)
379723|NCT00432458|B1|Baseline|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
379724|NCT00432458|P2|Participant Flow|Arm II: ZLD|Zoledronic acid (ZLD)
379725|NCT00432458|P1|Participant Flow|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
379737|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
379738|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
379739|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
379740|NCT00432458|E2|Reported Event|Arm II: ZLD|Zoledronic acid (ZLD)
379741|NCT00432458|E1|Reported Event|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
379742|NCT00432562|B3|Baseline|Total|Total of all reporting groups
379743|NCT00432562|B2|Baseline|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
379744|NCT00432562|B1|Baseline|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
379745|NCT00432562|P2|Participant Flow|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
379746|NCT00432562|P1|Participant Flow|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
379747|NCT00432562|O2|Outcome|Navelbine|
379748|NCT00432562|O1|Outcome|ANX-530|
379749|NCT00432562|O2|Outcome|Navelbine|
379750|NCT00432562|O1|Outcome|ANX-530|
379751|NCT00432562|O2|Outcome|Navelbine|
379752|NCT00432562|O1|Outcome|ANX-530|
379753|NCT00432562|O2|Outcome|Navelbine|
379754|NCT00432562|O1|Outcome|ANX-530|
379755|NCT00432562|O2|Outcome|Navelbine|
379756|NCT00432562|O1|Outcome|ANX-530|
379757|NCT00432562|O2|Outcome|Navelbine|
379758|NCT00432562|O1|Outcome|ANX-530|
379759|NCT00432562|O2|Outcome|Navelbine|
379760|NCT00432562|O1|Outcome|ANX-530|
379761|NCT00432562|O2|Outcome|Navelbine|
379762|NCT00432562|O1|Outcome|ANX-530|
379763|NCT00432562|O2|Outcome|Navelbine|
379764|NCT00432562|O1|Outcome|ANX-530|
379765|NCT00432562|O2|Outcome|Navelbine|
379766|NCT00432562|O1|Outcome|ANX-530|
379767|NCT00432562|E2|Reported Event|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
379768|NCT00432562|E1|Reported Event|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
379769|NCT00432601|B3|Baseline|Total|Total of all reporting groups
379770|NCT00432601|B2|Baseline|Arm 2|"Patients will receive National Comprehensive Cancer Network decision aid.
type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
379771|NCT00432601|B1|Baseline|Arm 1|"Patients will receive Michigan Cancer Consortium decision aid.
type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
379772|NCT00432601|P2|Participant Flow|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.
type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
379986|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
379773|NCT00432601|P1|Participant Flow|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.
type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
379774|NCT00432601|O2|Outcome|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.
type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
379775|NCT00432601|O1|Outcome|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.
type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
379776|NCT00432601|E2|Reported Event|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.
type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
379777|NCT00432601|E1|Reported Event|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.
type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
379778|NCT00432666|B3|Baseline|Total|Total of all reporting groups
379779|NCT00432666|B2|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379780|NCT00432666|B1|Baseline|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379781|NCT00432666|P2|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379782|NCT00432666|P1|Participant Flow|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
380128|NCT00433199|B1|Baseline|Placebo|Placebo comparator administered during the Double-Blind period only
379783|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379784|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379785|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379786|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379787|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379788|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379789|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379790|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379791|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379792|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379793|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379794|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379795|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379796|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379797|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379798|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379799|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379800|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379801|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
380772|NCT00434993|E2|Reported Event|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
379802|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379803|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379804|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379805|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379806|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379807|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379808|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379809|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379810|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379811|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379812|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379813|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379814|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379815|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379816|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379817|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379818|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379819|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379820|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379821|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379822|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379823|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379824|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379825|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379826|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379827|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379828|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379829|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379830|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379979|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379831|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379832|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379833|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379834|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379835|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379836|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379837|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379838|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379839|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379840|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379841|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379842|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379843|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379844|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379845|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379846|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379847|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379848|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379849|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379850|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379851|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379852|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379853|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379854|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379855|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379856|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379857|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379858|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379859|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379980|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
379860|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379861|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379862|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379863|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379864|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379865|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379866|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379867|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379868|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379869|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379870|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379871|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379872|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379873|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379874|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379875|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379876|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379877|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379878|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379879|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379880|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379881|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379882|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379883|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379884|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379885|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379886|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379887|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379888|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379981|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379889|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379890|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379891|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379892|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379893|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379894|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379895|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379896|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379897|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379898|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379899|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379900|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379901|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379902|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379903|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379904|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379905|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379906|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379907|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379908|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379909|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379910|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379911|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379912|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379913|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379914|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379915|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379916|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379917|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
380853|NCT00435162|P1|Participant Flow|Low Dose in Both Periods|Valsartan 0.25 mg/kg in both periods
379918|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379919|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379920|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379921|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379922|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379923|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379924|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379925|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379926|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379927|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379928|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379929|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379930|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379931|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379932|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379933|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379934|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379935|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379936|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379937|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379938|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379939|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379940|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379941|NCT00432666|E2|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
379942|NCT00432666|E1|Reported Event|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
379943|NCT00432744|B3|Baseline|Total|Total of all reporting groups
379944|NCT00432744|B2|Baseline|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)
CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.
Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
379945|NCT00432744|B1|Baseline|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)
Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.
CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
380854|NCT00435162|O2|Outcome|Placebo|
379946|NCT00432744|P2|Participant Flow|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)
CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.
Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
379947|NCT00432744|P1|Participant Flow|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)
Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.
CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
379948|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)
CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.
Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
379949|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)
Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.
CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
379950|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)
CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.
Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
382074|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
379951|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)
Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.
CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
379952|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)
CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.
Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
379953|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)
Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.
CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
379954|NCT00432744|E2|Reported Event|Placebo|Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group. (Either in Period 1 or Period 2)
379955|NCT00432744|E1|Reported Event|CoenzymeQ10|CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed. (Either in Period 1 or Period 2)
379956|NCT00432809|B4|Baseline|Total|Total of all reporting groups
379957|NCT00432809|B3|Baseline|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379958|NCT00432809|B2|Baseline|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379959|NCT00432809|B1|Baseline|Medical Therapy|Intensive medical therapy for diabetes
379960|NCT00432809|P3|Participant Flow|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379961|NCT00432809|P2|Participant Flow|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379962|NCT00432809|P1|Participant Flow|Medical Therapy|Intensive medical therapy for diabetes
379963|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379964|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379965|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
379966|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379967|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379968|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
379969|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379970|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379971|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
379972|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379973|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379974|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
379975|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
380855|NCT00435162|O1|Outcome|Valsartan|pooled across all dosage levels
379987|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379988|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379989|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
379990|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379991|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379992|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
379993|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379994|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379995|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
379996|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
379997|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
379998|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
379999|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
380000|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
380001|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
380002|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
409602|NCT00510692|B3|Baseline|Total|Total of all reporting groups
380003|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
380004|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
380005|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
380006|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
380007|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
380008|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
380009|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
380010|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
380011|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
380012|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
380013|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
380014|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
380015|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
380016|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
380017|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
380018|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
380019|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
380020|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
380021|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
380022|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
380023|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
380024|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
380025|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
380026|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
380027|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
380028|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
380029|NCT00432809|E3|Reported Event|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
380030|NCT00432809|E2|Reported Event|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
380031|NCT00432809|E1|Reported Event|Medical Therapy|Intensive medical therapy for diabetes
380032|NCT00432835|B3|Baseline|Total|Total of all reporting groups
380033|NCT00432835|B2|Baseline|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
380110|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380111|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380034|NCT00432835|B1|Baseline|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
380035|NCT00432835|P2|Participant Flow|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
380036|NCT00432835|P1|Participant Flow|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
380037|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
380038|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
380291|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380039|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
380040|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
380041|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
380042|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
380043|NCT00432835|E2|Reported Event|Gastric StimulationNotActivated|Sham stimulation
380044|NCT00432835|E1|Reported Event|Gastric Stimactivated|Gastric Electrical Stimulation
380045|NCT00432991|B3|Baseline|Total|Total of all reporting groups
380046|NCT00432991|B2|Baseline|IM Ephedrine|"IM Ephedrine
Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
380047|NCT00432991|B1|Baseline|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
380048|NCT00432991|P2|Participant Flow|IM Ephedrine|"IM Ephedrine
Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
380049|NCT00432991|P1|Participant Flow|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
380050|NCT00432991|O2|Outcome|IM Ephedrine|"IM Ephedrine
Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
380051|NCT00432991|O1|Outcome|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
380052|NCT00432991|O2|Outcome|IM Ephedrine|"IM Ephedrine
Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
380053|NCT00432991|O1|Outcome|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
380054|NCT00432991|O2|Outcome|IM Ephedrine|"IM Ephedrine
Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
380055|NCT00432991|O1|Outcome|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
380056|NCT00432991|E2|Reported Event|IM Ephedrine|"IM Ephedrine
Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
380057|NCT00432991|E1|Reported Event|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
380058|NCT00433017|B3|Baseline|Total|Total of all reporting groups
380059|NCT00433017|B2|Baseline|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380060|NCT00433017|B1|Baseline|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380061|NCT00433017|P2|Participant Flow|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380062|NCT00433017|P1|Participant Flow|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380063|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380064|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380065|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380066|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380067|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380068|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380069|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380070|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380856|NCT00435162|O2|Outcome|Placebo|
380071|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380072|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380073|NCT00433017|E2|Reported Event|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380074|NCT00433017|E1|Reported Event|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
380075|NCT00433160|B3|Baseline|Total|Total of all reporting groups
380076|NCT00433160|B2|Baseline|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380077|NCT00433160|B1|Baseline|Teriparatide|20 micrograms for 104 weeks
380078|NCT00433160|P2|Participant Flow|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380079|NCT00433160|P1|Participant Flow|Teriparatide|20 micrograms for 104 weeks
380080|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380081|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380082|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380083|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380084|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380085|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380086|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380087|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380088|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380089|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380090|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380091|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380092|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380093|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380094|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380095|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380096|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380097|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380098|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380099|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380100|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380101|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380102|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380103|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380104|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380105|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380106|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380107|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380108|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380109|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380112|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380113|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380114|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380115|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380116|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380117|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380118|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380119|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
380120|NCT00433160|E6|Reported Event|Placebo (During 104 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380121|NCT00433160|E5|Reported Event|Teriparatide (During 104 Weeks)|20 micrograms for 104 weeks
380122|NCT00433160|E4|Reported Event|Placebo (During 76 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380123|NCT00433160|E3|Reported Event|Teriparatide (During 76 Weeks)|20 micrograms for 104 weeks
380124|NCT00433160|E2|Reported Event|Placebo (During 52 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
380125|NCT00433160|E1|Reported Event|Teriparatide (During 52 Weeks)|20 micrograms for 104 weeks
380126|NCT00433199|B3|Baseline|Total|Total of all reporting groups
380127|NCT00433199|B2|Baseline|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
380129|NCT00433199|P2|Participant Flow|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
380130|NCT00433199|P1|Participant Flow|Placebo|Placebo comparator administered during the Double-Blind period only
380131|NCT00433199|O3|Outcome|Combined (CA and FP)|Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
380132|NCT00433199|O2|Outcome|Formerly Placebo (FP)|Placebo given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
380133|NCT00433199|O1|Outcome|Continuing Active T-Gel 1.62% (CA)|Testosterone gel 1.62% given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
380134|NCT00433199|O3|Outcome|Combined (CA and FP)|Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
380135|NCT00433199|O2|Outcome|Formerly Placebo (FP)|Placebo group given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
380136|NCT00433199|O1|Outcome|Continuing Active T-Gel 1.62% (CA)|Testosterone gel 1.62% given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
380137|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
380138|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
380139|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
380140|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
380141|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
380142|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
380143|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
380144|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
380145|NCT00433199|E2|Reported Event|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
380146|NCT00433199|E1|Reported Event|Placebo|Placebo comparator administered during the Double-Blind period only
380147|NCT00433290|B3|Baseline|Total|Total of all reporting groups
380148|NCT00433290|B2|Baseline|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380149|NCT00433290|B1|Baseline|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380150|NCT00433290|P2|Participant Flow|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380151|NCT00433290|P1|Participant Flow|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380152|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380153|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380154|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380155|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380156|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380157|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380158|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380160|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380161|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380162|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380163|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380164|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380165|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380166|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380167|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380168|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380169|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380170|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380171|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
413936|NCT00522925|E1|Reported Event|1- Placebo|Placebo
380172|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380173|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380174|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380175|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380176|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380177|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380178|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380179|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380180|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380181|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380182|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380183|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380184|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380185|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380186|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380187|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380188|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380189|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380190|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380191|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380192|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380193|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380194|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380195|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380196|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380197|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380266|NCT00433654|B1|Baseline|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380857|NCT00435162|O1|Outcome|Valsartan|pooled across all dosage levels
380198|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380199|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380200|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380201|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380202|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380203|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380204|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380205|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380206|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380207|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380208|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380209|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380210|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380211|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380212|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380213|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380214|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380215|NCT00433290|E2|Reported Event|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
380216|NCT00433290|E1|Reported Event|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
380217|NCT00433329|B1|Baseline|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
380218|NCT00433329|P1|Participant Flow|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
380219|NCT00433329|O1|Outcome|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
380220|NCT00433329|E1|Reported Event|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
380221|NCT00433381|B3|Baseline|Total|Total of all reporting groups
380222|NCT00433381|B2|Baseline|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
380223|NCT00433381|B1|Baseline|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
380224|NCT00433381|P2|Participant Flow|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
380225|NCT00433381|P1|Participant Flow|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
380226|NCT00433381|O1|Outcome|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
380227|NCT00433381|O1|Outcome|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as definted by stable or responding tumor.
380228|NCT00433381|E2|Reported Event|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 57 patients.
380267|NCT00433654|P2|Participant Flow|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
380229|NCT00433381|E1|Reported Event|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 60.
380230|NCT00433446|B1|Baseline|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
380231|NCT00433446|P1|Participant Flow|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
380232|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
380233|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
380234|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
380235|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
380236|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
380237|NCT00433446|E1|Reported Event|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
380238|NCT00433537|B1|Baseline|Step 1 - VcR-CVAD Induction|All eligible patients who received VcR-CVAD induction.
380239|NCT00433537|P3|Participant Flow|VcR-CVAD Induction Then Off Study|Patients received VcR-CVAD induction but did not proceed to step 2 treatment for various reasons.
380252|NCT00433550|B1|Baseline|Group 1 (6/6 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15
414146|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
380240|NCT00433537|P2|Participant Flow|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
380241|NCT00433537|P1|Participant Flow|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneous (SC) or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
380242|NCT00433537|O2|Outcome|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
380243|NCT00433537|O1|Outcome|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
380244|NCT00433537|O2|Outcome|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
380268|NCT00433654|P1|Participant Flow|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380269|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
380270|NCT00433654|O1|Outcome|5086 MRI Lead|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380271|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
380272|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380273|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
380245|NCT00433537|O1|Outcome|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
380246|NCT00433537|O1|Outcome|VcR-CVAD Induction|All eligible patients who received VcR-CVAD induction.
380247|NCT00433537|E2|Reported Event|Step 2 - Maintenance Rituximab|All patients who received maintenance rituximab.
380248|NCT00433537|E1|Reported Event|Step 1 - VcR-CVAD Induction|All patients who received VcR-CVAD induction.
380249|NCT00433550|B4|Baseline|Total|Total of all reporting groups
380250|NCT00433550|B3|Baseline|Group 3 (7/7 UGT1A1 Genotype)|Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
380251|NCT00433550|B2|Baseline|Group 2 (6/7 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
380253|NCT00433550|P3|Participant Flow|Group 3 (7/7 UGT1A1 Genotype)|Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
380254|NCT00433550|P2|Participant Flow|Group 2 (6/7 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
380255|NCT00433550|P1|Participant Flow|Group 1 (6/6 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15
380256|NCT00433550|O1|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15 > > Group 2 (6/7 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15. >
> Group 3 (7/7 UGT1A1 genotype): > Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
380257|NCT00433550|O1|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15 > > Group 2 (6/7 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15. >
> Group 3 (7/7 UGT1A1 genotype): > Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
380258|NCT00433550|O1|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype):
> Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15
>
>
Group 2 (6/7 UGT1A1 genotype):
> Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15.
>
>
Group 3 (7/7 UGT1A1 genotype):
> Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
380259|NCT00433550|O1|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15 > > Group 2 (6/7 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15. >
> Group 3 (7/7 UGT1A1 genotype): > Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
380260|NCT00433550|O1|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype):
Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15
Group 2 (6/7 UGT1A1 genotype):
Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15.
Group 3 (7/7 UGT1A1 genotype):
Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
380261|NCT00433550|E3|Reported Event|Group 3 (7/7 UGT1A1 Genotype)|Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
380262|NCT00433550|E2|Reported Event|Group 2 (6/7 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
380263|NCT00433550|E1|Reported Event|Group 1 (6/6 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15
380274|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380275|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
380276|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380277|NCT00433654|O1|Outcome|5086 MRI Lead|The 5086 MRI lead was used by all subjects in this study
380278|NCT00433654|O1|Outcome|5086 MRI Lead|The 5086 MRI lead was used by all subjects in this study
380279|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
380280|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380281|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
380282|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380283|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380284|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380285|NCT00433654|O1|Outcome|Implanted Subjects|All subjects undergoing an implant attempt
380286|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
380287|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380288|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
380289|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380290|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
380292|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
380293|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380294|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380295|NCT00433654|E3|Reported Event|Non-randomized|Some subjects were enrolled, but either did not receive a system, or received only a partial system, and were not randomized. Their adverse events were collected until they exited the study.
380296|NCT00433654|E2|Reported Event|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
380297|NCT00433654|E1|Reported Event|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
380298|NCT00433745|B1|Baseline|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
380299|NCT00433745|P1|Participant Flow|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
380300|NCT00433745|O1|Outcome|WT1 Peptide Vaccine|"All 4 patients who were accrued went on to receive the vaccine.
Complete Response (CR): defined as an absolute neutrophil count of ≥500/µL, platelet count of ≥75,000/µL, no leukemic blasts in the blood nor evidence of extramedullary leukemia, bone marrow (BM) with a cellularity of more than 20%, maturation of all three cell lineages, no Auer rods, and less than 5% bone marrow blast cells.
Partial response (PR): 50% reduction in marrow blasts, with an absolute neutrophil count (ANC) greater than 500/µL, and platelet count greater than 75000/µL.
No response: subjects who did not meet the above response criteria were defined as non-responders."
380301|NCT00433745|O1|Outcome|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
380302|NCT00433745|E1|Reported Event|WT1 Peptide Vaccine|All 4 patients who were accrued went on to receive the vaccine
380303|NCT00433771|B1|Baseline|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380304|NCT00433771|P1|Participant Flow|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380305|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380306|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380307|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380308|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380309|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380310|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380311|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380312|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380313|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380314|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380315|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380316|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380317|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380318|NCT00433771|E1|Reported Event|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
380319|NCT00433836|B3|Baseline|Total|Total of all reporting groups
380320|NCT00433836|B2|Baseline|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
380321|NCT00433836|B1|Baseline|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
380322|NCT00433836|P2|Participant Flow|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
380323|NCT00433836|P1|Participant Flow|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
380324|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
380325|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
380326|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
380327|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
380328|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
380329|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
380330|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
380331|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
380332|NCT00433836|E2|Reported Event|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
380333|NCT00433836|E1|Reported Event|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
380334|NCT00433914|B3|Baseline|Total|Total of all reporting groups
380335|NCT00433914|B2|Baseline|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380336|NCT00433914|B1|Baseline|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
442781|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
380337|NCT00433914|P2|Participant Flow|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380338|NCT00433914|P1|Participant Flow|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380339|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380340|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380341|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380342|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380343|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380344|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380345|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380346|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380347|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380348|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380349|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380350|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380351|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380352|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380353|NCT00433914|E2|Reported Event|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380354|NCT00433914|E1|Reported Event|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
380355|NCT00433992|B3|Baseline|Total|Total of all reporting groups
380356|NCT00433992|B2|Baseline|TDF/FTC|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
380357|NCT00433992|B1|Baseline|ABC/3TC|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
380358|NCT00433992|P2|Participant Flow|TDF/FTC|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
380359|NCT00433992|P1|Participant Flow|ABC/3TC|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
380360|NCT00433992|O4|Outcome|ATV/r +ABC/3TC|HIV-infected subjects taking atazanavir-ritonavir with abacavir-lamivudine at baseline
380361|NCT00433992|O3|Outcome|ATV/r +TDF/FTC|HIV infected subjects taking atazanavir-ritonavir with tenofovir DF-emtricitabine at baseline
380362|NCT00433992|O2|Outcome|TDF/FTC+EFV|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with Efavirenz at baseline
380363|NCT00433992|O1|Outcome|ABC/3TC+EFV|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC) with Efavirenz at baseline
380364|NCT00433992|E2|Reported Event|TDF/FTC|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
380365|NCT00433992|E1|Reported Event|ABC/3TC|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
380366|NCT00415597|B1|Baseline|ALO-01|
380367|NCT00415597|P1|Participant Flow|ALO-01|
380368|NCT00415597|O1|Outcome|ALO-01|
380369|NCT00415597|O1|Outcome|ALO-01|
380373|NCT00415610|B3|Baseline|Tier 3|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 110 to 140 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.
nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
380374|NCT00415610|B2|Baseline|Tier 2|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 140 to 170 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.
nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
380411|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
380412|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
442782|NCT00594425|O3|Outcome|Vehicle PDT|
380375|NCT00415610|B1|Baseline|Tier 1|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 170 to 200 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.
nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
380376|NCT00415610|P3|Participant Flow|Tier 3|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
380377|NCT00415610|P2|Participant Flow|Tier 2|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
380378|NCT00415610|P1|Participant Flow|Tier 1|"Dose escalation: Initial range
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
380379|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
380380|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
380381|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
380401|NCT00415623|O1|Outcome|Baseline|After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
380402|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
380403|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
380382|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
380383|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
380413|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
380414|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
384850|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
380384|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
380385|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
380386|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
380387|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
380388|NCT00415610|E3|Reported Event|Tier 3|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
380389|NCT00415610|E2|Reported Event|Tier 2|"Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
380390|NCT00415610|E1|Reported Event|Tier 1|"Dose escalation: Initial range
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg
Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.
The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
380391|NCT00415623|B3|Baseline|Total|Total of all reporting groups
380392|NCT00415623|B2|Baseline|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
380393|NCT00415623|B1|Baseline|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
380394|NCT00415623|P2|Participant Flow|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
380395|NCT00415623|P1|Participant Flow|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
380396|NCT00415623|O3|Outcome|Week 8|
380397|NCT00415623|O2|Outcome|Week 4|
380398|NCT00415623|O1|Outcome|Baseline|After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
380399|NCT00415623|O3|Outcome|Week 8|
380404|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
380405|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
380406|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
380407|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
380408|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
380409|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
380410|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
380613|NCT00434161|E2|Reported Event|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380415|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
380416|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
380417|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
380418|NCT00415857|B3|Baseline|Total|Total of all reporting groups
380419|NCT00415857|B2|Baseline|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
380420|NCT00415857|B1|Baseline|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
380421|NCT00415857|P2|Participant Flow|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
380422|NCT00415857|P1|Participant Flow|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
380423|NCT00415857|O2|Outcome|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
380424|NCT00415857|O1|Outcome|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
380425|NCT00415857|O2|Outcome|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
380426|NCT00415857|O1|Outcome|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
380427|NCT00415857|E2|Reported Event|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
380428|NCT00415857|E1|Reported Event|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
380429|NCT00415870|B3|Baseline|Total|Total of all reporting groups
380430|NCT00415870|B2|Baseline|PACE: Intervention - SMS Messages and Lifestyle Counseling|
380431|NCT00415870|B1|Baseline|Control: Enhanced Usual Care|
380432|NCT00415870|P2|Participant Flow|PACE|"Received text messages and counseling calls
Food Monitoring : Food Monitoring
Text Message : Text Message
Cell phone will serve as a self monitoring device : Cell phone will serve as a self monitoring device
Diet Goals via Cell Phone : Diet Goals via Cell Phone
Weekly Weighing : Weekly Weighing
Printed Material : Printed Material"
380433|NCT00415870|P1|Participant Flow|Control|
380434|NCT00415870|O2|Outcome|PACE: Intervention - SMS Messages|
380435|NCT00415870|O1|Outcome|Control:Enhanced Usual Care|
380593|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
390902|NCT00460239|E3|Reported Event|Buprenorphine Intervention|
380436|NCT00415870|E2|Reported Event|PACE|"Received text messages and counseling calls
Food Monitoring : Food Monitoring
Text Message : Text Message
Cell phone will serve as a self monitoring device : Cell phone will serve as a self monitoring device
Diet Goals via Cell Phone : Diet Goals via Cell Phone
Weekly Weighing : Weekly Weighing
Printed Material : Printed Material"
380437|NCT00415870|E1|Reported Event|Control|
380438|NCT00415909|B1|Baseline|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy
Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.
TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
380439|NCT00415909|P1|Participant Flow|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy. Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.
T Acute Lymphoblastic Leukemia/Lymphoma (TALL)-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
380440|NCT00415909|O1|Outcome|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy
Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.
TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
380441|NCT00415909|E1|Reported Event|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy
Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.
TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
380442|NCT00416078|B3|Baseline|Total|Total of all reporting groups
380443|NCT00416078|B2|Baseline|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year customary care
380444|NCT00416078|B1|Baseline|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
380445|NCT00416078|P2|Participant Flow|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
380446|NCT00416078|P1|Participant Flow|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
380447|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
380448|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
380449|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
380450|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
380451|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
380452|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
380453|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
380454|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
380455|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
380456|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
380457|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
380458|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
380459|NCT00416078|E2|Reported Event|Caregiver Brief Supportive Phone Calls|caregiver brief supportive telephone calls for 6 months embedded in one year of customary care
380460|NCT00416078|E1|Reported Event|Caregiver Website Support|caregiver access to website support for 6 months embedded in one year of customary care
380461|NCT00416182|B3|Baseline|Total|Total of all reporting groups
380462|NCT00416182|B2|Baseline|Placebo|2.5 mL of placebo comparator
380463|NCT00416182|B1|Baseline|Pulmozyme (Dornase Alfa)|2.5 mg/2.5 mL of intranasal Pulmozyme
380464|NCT00416182|P2|Participant Flow|Placebo|2.5mg/2.5mL placebo administered intranasally once daily
380465|NCT00416182|P1|Participant Flow|Pulmozyme (Dornase Alfa)|2.5 mg/2.5mL of Pulmozyme administered intranasally once daily
380466|NCT00416182|O2|Outcome|Placebo|Percent predicted forced expiratory volume in 1 second recorded
380467|NCT00416182|O1|Outcome|Pulmozyme|Percent predicted for forced expiratory volume in 1 second recorded
380468|NCT00416182|O2|Outcome|Placebo|Scores from the Chronic Sinusitis Survey recorded
380469|NCT00416182|O1|Outcome|Pulmozyme|Scores from the Chronic Sinusitis Survey
380470|NCT00416182|O2|Outcome|Placebo|endoscopic photos of sinuses by ENT surgeon, independently and blindly scored by two surgeons. Scores of 0,1,2 based on disease severity.
380471|NCT00416182|O1|Outcome|Pulmozyme|endoscopic photos of sinuses by ENT surgeon independently and blindly scored by two surgeons with scale of 0,1,2 to indicate severity of disease
380472|NCT00416182|O2|Outcome|Placebo|Patients receiving intranasal placebo once daily
380473|NCT00416182|O1|Outcome|Pulmozyme|Patients receiving 2.5 mg intranasal Pulmozyme once daily
380474|NCT00416182|E2|Reported Event|Placebo|patients receiving once daily intranasal placebo
380475|NCT00416182|E1|Reported Event|Pulmozyme|patients receiving once daily intranasal Pulmozyme
380476|NCT00416195|B3|Baseline|Total|Total of all reporting groups
380594|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
390903|NCT00460239|E2|Reported Event|Morphine Intervention|
380477|NCT00416195|B2|Baseline|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
380478|NCT00416195|B1|Baseline|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
380479|NCT00416195|P2|Participant Flow|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
380480|NCT00416195|P1|Participant Flow|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
380481|NCT00416195|O2|Outcome|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
380482|NCT00416195|O1|Outcome|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
384930|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
380483|NCT00416195|O2|Outcome|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
380484|NCT00416195|O1|Outcome|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
380485|NCT00416195|E2|Reported Event|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
380486|NCT00416195|E1|Reported Event|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
380487|NCT00434018|B3|Baseline|Total|Total of all reporting groups
380488|NCT00434018|B2|Baseline|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
380489|NCT00434018|B1|Baseline|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
380490|NCT00434018|P2|Participant Flow|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
380491|NCT00434018|P1|Participant Flow|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
380492|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
380493|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
380494|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
380495|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
380496|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
380497|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
380498|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
380499|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
380500|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
380595|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
380596|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
380501|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
380502|NCT00434018|O2|Outcome|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
380503|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
380504|NCT00434018|E2|Reported Event|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
380505|NCT00434018|E1|Reported Event|Wheelchair Skills Training|Wheelchair Skills Training: Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.
380506|NCT00434057|B1|Baseline|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
381012|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
380507|NCT00434057|P1|Participant Flow|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
380508|NCT00434057|O1|Outcome|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
380509|NCT00434057|E1|Reported Event|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
380510|NCT00434109|B1|Baseline|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
380511|NCT00434109|P1|Participant Flow|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
380512|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
380513|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
380514|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
380515|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
380516|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
380517|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
380518|NCT00434109|E1|Reported Event|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
380519|NCT00434122|B3|Baseline|Total|Total of all reporting groups
380520|NCT00434122|B2|Baseline|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
380521|NCT00434122|B1|Baseline|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
380522|NCT00434122|P2|Participant Flow|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
380523|NCT00434122|P1|Participant Flow|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
380524|NCT00434122|O3|Outcome|Ganirelix, 0.25 mg|Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
380525|NCT00434122|O2|Outcome|Degarelix Follicular, 2.5 mg|Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6
380526|NCT00434122|O1|Outcome|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
380527|NCT00434122|O2|Outcome|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
380528|NCT00434122|O1|Outcome|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
380529|NCT00434122|E2|Reported Event|Ganirelix, 0.25 mg|Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
380530|NCT00434122|E1|Reported Event|Degarelix, 2.5 mg|"Combination of these two groups: Degarelix Mid-luteal 2.5 mg and Degarelix Follicular 2.5 mg.
Degarelix Mid-luteal, 2.5 mg: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
Degarelix Follicular, 2.5 mg: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6."
380531|NCT00434148|B3|Baseline|Total|Total of all reporting groups
380532|NCT00434148|B2|Baseline|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380612|NCT00434161|E3|Reported Event|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). A total of 115 subjects were randomized to treatment and 113 received at least one dose of study treatment. Due to protocol deviations additional 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 109 subjects were included in this safety analysis set.
380533|NCT00434148|B1|Baseline|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380534|NCT00434148|P2|Participant Flow|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380535|NCT00434148|P1|Participant Flow|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380536|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380537|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380538|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380539|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380540|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380541|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380597|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380598|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
380599|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380542|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380543|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380544|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380545|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380546|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380547|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380548|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380549|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380550|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380551|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380552|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380600|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
380601|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380858|NCT00435162|O3|Outcome|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
380553|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380554|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380555|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380556|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380557|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380558|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380559|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380560|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380561|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380562|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380563|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380602|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
380603|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
380564|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380565|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
380566|NCT00434148|E2|Reported Event|Pasireotide 900 ug|At randomization, participants received 900 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380567|NCT00434148|E1|Reported Event|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
380568|NCT00434161|B4|Baseline|Total|Total of all reporting groups
380569|NCT00434161|B3|Baseline|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
380570|NCT00434161|B2|Baseline|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380571|NCT00434161|B1|Baseline|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
380572|NCT00434161|P3|Participant Flow|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy
380573|NCT00434161|P2|Participant Flow|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of placebo as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy.
380574|NCT00434161|P1|Participant Flow|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and placebo on Days 0, 1 and 2 after high dose chemotherapy.
380575|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380576|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
380577|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380578|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
380579|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380580|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
380581|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
380582|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380583|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380584|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
380585|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy
380586|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380587|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy
380588|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
380589|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
380590|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
380591|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
380592|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
380604|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380605|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
380606|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
380607|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380608|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
380609|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy
380610|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
380611|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy
380614|NCT00434161|E1|Reported Event|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). A total of 109 subjects were randomized to treatment and 107 received at least one dose of study treatment. Due to protocol deviations 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 111 subjects were included in this safety analysis set.
380615|NCT00434213|B1|Baseline|Daytrana|Methylphenidate Transdermal System (MTS)
380616|NCT00434213|P1|Participant Flow|Daytrana|Methylphenidate Transdermal System (MTS)
380617|NCT00434213|O1|Outcome|Daytrana|Methylphenidate Transdermal System (MTS)
380618|NCT00434213|O1|Outcome|Daytrana|Methylphenidate Transdermal System (MTS)
380619|NCT00434213|E1|Reported Event|Daytrana|Methylphenidate Transdermal System (MTS)
380620|NCT00434226|B3|Baseline|Total|Total of all reporting groups
380621|NCT00434226|B2|Baseline|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
380622|NCT00434226|B1|Baseline|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
380623|NCT00434226|P2|Participant Flow|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
380624|NCT00434226|P1|Participant Flow|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
380625|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
380626|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
380627|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
380628|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
380629|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
380630|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
380631|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
380632|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
380633|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
380634|NCT00434252|B3|Baseline|Total|Total of all reporting groups
380635|NCT00434252|B2|Baseline|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
380636|NCT00434252|B1|Baseline|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
384094|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
380637|NCT00434252|P2|Participant Flow|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
380638|NCT00434252|P1|Participant Flow|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
380639|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
380640|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
380641|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
384931|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
380642|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
380643|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
380644|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
380645|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
380646|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
380647|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
380648|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
380649|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
380650|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
380651|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
380652|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
380653|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
380654|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
380655|NCT00434252|E2|Reported Event|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
380656|NCT00434252|E1|Reported Event|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
380657|NCT00434278|B3|Baseline|Total|Total of all reporting groups
380658|NCT00434278|B2|Baseline|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
380659|NCT00434278|B1|Baseline|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
380660|NCT00434278|P2|Participant Flow|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
380661|NCT00434278|P1|Participant Flow|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
380662|NCT00434278|O2|Outcome|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
380663|NCT00434278|O1|Outcome|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
380664|NCT00434278|O2|Outcome|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
380665|NCT00434278|O1|Outcome|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
380666|NCT00434278|E2|Reported Event|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
380667|NCT00434278|E1|Reported Event|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
380668|NCT00434304|B1|Baseline|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380669|NCT00434304|P1|Participant Flow|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380670|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380671|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380672|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380673|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380674|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380675|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380676|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380677|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380678|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380679|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380702|NCT00434304|E2|Reported Event|Ropinirole PR/XR (Taper Phase)|The dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380781|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
381013|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
380680|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380681|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380682|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380683|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380684|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380685|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380686|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380687|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380688|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380717|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380773|NCT00434993|E1|Reported Event|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380689|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380690|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380691|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380692|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380693|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380694|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380695|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380696|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380697|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380698|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380699|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380718|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380774|NCT00435019|B3|Baseline|Total|Total of all reporting groups
384095|NCT00441480|O2|Outcome|Control|Corn oil
380700|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380701|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
380703|NCT00434304|E1|Reported Event|Ropinirole PR/XR (Treatment Phase)|Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 mg as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52.
380704|NCT00434330|B7|Baseline|Total|Total of all reporting groups
380705|NCT00434330|B6|Baseline|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380706|NCT00434330|B5|Baseline|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380707|NCT00434330|B4|Baseline|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380708|NCT00434330|B3|Baseline|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380709|NCT00434330|B2|Baseline|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380710|NCT00434330|B1|Baseline|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380711|NCT00434330|P6|Participant Flow|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380712|NCT00434330|P5|Participant Flow|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380713|NCT00434330|P4|Participant Flow|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380714|NCT00434330|P3|Participant Flow|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380715|NCT00434330|P2|Participant Flow|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380716|NCT00434330|P1|Participant Flow|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380769|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380770|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380719|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380720|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380721|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380870|NCT00435188|B3|Baseline|Total|Total of all reporting groups
380871|NCT00435188|B2|Baseline|Arm 2|Usual care
380722|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380723|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380724|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380725|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380726|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380727|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380728|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380729|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380730|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380731|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380732|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380733|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380734|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380735|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380771|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380736|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380737|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380738|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
381438|NCT00436852|B3|Baseline|Total|Total of all reporting groups
380739|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380740|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380741|NCT00434330|E6|Reported Event|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380742|NCT00434330|E5|Reported Event|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380743|NCT00434330|E4|Reported Event|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380744|NCT00434330|E3|Reported Event|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
380745|NCT00434330|E2|Reported Event|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380746|NCT00434330|E1|Reported Event|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
380747|NCT00434993|B3|Baseline|Total|Total of all reporting groups
380748|NCT00434993|B2|Baseline|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380749|NCT00434993|B1|Baseline|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380750|NCT00434993|P2|Participant Flow|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380751|NCT00434993|P1|Participant Flow|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380752|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380753|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380754|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380755|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380756|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380757|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380758|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380759|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380760|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380761|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380762|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380763|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380764|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380765|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380766|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380767|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
380768|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
380775|NCT00435019|B2|Baseline|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
380776|NCT00435019|B1|Baseline|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
380777|NCT00435019|P2|Participant Flow|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
380778|NCT00435019|P1|Participant Flow|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
380779|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
380780|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
380782|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
380783|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
380784|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
380785|NCT00435019|E2|Reported Event|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
380786|NCT00435019|E1|Reported Event|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
380787|NCT00435045|B3|Baseline|Total|Total of all reporting groups
380788|NCT00435045|B2|Baseline|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380789|NCT00435045|B1|Baseline|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380790|NCT00435045|P2|Participant Flow|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380791|NCT00435045|P1|Participant Flow|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380792|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380793|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380794|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380795|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380796|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380797|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380798|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380799|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380800|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380801|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380851|NCT00435162|P3|Participant Flow|Medium Dose in Both Periods|Valsartan 1.0 mg/kg in both periods
380802|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380803|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380804|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380805|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380911|NCT00435188|E2|Reported Event|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
380806|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380807|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380808|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380809|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380810|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380811|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380812|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380813|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380814|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380815|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380816|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380817|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380818|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380819|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380820|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380821|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380822|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380823|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380852|NCT00435162|P2|Participant Flow|Low Dose, Then Placebo|Valsartan 0.25 mg/kg, then placebo
390904|NCT00460239|E1|Reported Event|Placebo Intervention|
380824|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380825|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380826|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380827|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380828|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380829|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380830|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380831|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380832|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380833|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380834|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380835|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380836|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380837|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380838|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380839|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380840|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380841|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380842|NCT00435045|E2|Reported Event|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
380843|NCT00435045|E1|Reported Event|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
380844|NCT00435162|B4|Baseline|Total|Total of all reporting groups
380845|NCT00435162|B3|Baseline|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
380846|NCT00435162|B2|Baseline|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
380847|NCT00435162|B1|Baseline|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
380848|NCT00435162|P6|Participant Flow|High Dose, Then Placebo|Valsartan 4.0 mg/kg, then placebo
380849|NCT00435162|P5|Participant Flow|High Dose in Both Periods|Valsartan 1.0 mg/kg, then placebo
380850|NCT00435162|P4|Participant Flow|Medium Dose, Then Placebo|Valsartan 1.0 mg/kg, then placebo
380859|NCT00435162|O2|Outcome|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
380860|NCT00435162|O1|Outcome|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
380861|NCT00435162|O3|Outcome|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
380862|NCT00435162|O2|Outcome|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
380863|NCT00435162|O1|Outcome|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
380864|NCT00435162|E6|Reported Event|High Dose, Then Placebo|Valsartan 4.0 mg/kg, then Placebo
380865|NCT00435162|E5|Reported Event|High Dose in Both Periods|Valsartan 4.0 mg/kg in both periods
380866|NCT00435162|E4|Reported Event|Medium Dose, Then Placebo|Valsartan 1.0 mg/kg, then Placebo
380867|NCT00435162|E3|Reported Event|Medium Dose in Both Periods|Valsartan 1.0 mg/kg in both periods
380868|NCT00435162|E2|Reported Event|Low Dose, Then Placebo|Valsartan 0.25 mg/kg, then Placebo
380869|NCT00435162|E1|Reported Event|Low Dose in Both Periods|Valsartan 0.25 mg/kg in both periods
380872|NCT00435188|B1|Baseline|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic vis
380873|NCT00435188|P2|Participant Flow|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
380874|NCT00435188|P1|Participant Flow|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380875|NCT00435188|O2|Outcome|Arm 2|Usual care
380876|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380877|NCT00435188|O2|Outcome|Arm 2|Usual care
380878|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380879|NCT00435188|O2|Outcome|Arm 2|Usual care
380880|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380881|NCT00435188|O2|Outcome|Arm 2|Usual care
380882|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380883|NCT00435188|O2|Outcome|Arm 2|Usual care
380884|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380885|NCT00435188|O2|Outcome|Arm 2|Usual care
380886|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380887|NCT00435188|O2|Outcome|Arm 2|Usual care
380936|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
384096|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
380888|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380889|NCT00435188|O2|Outcome|Arm 2|Usual care
380890|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380891|NCT00435188|O2|Outcome|Arm 2|Usual care
442783|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
380892|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380893|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
380894|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380895|NCT00435188|O2|Outcome|Arm 2|Usual care
380896|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380897|NCT00435188|O2|Outcome|Arm 2|Usual care
380898|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380899|NCT00435188|O2|Outcome|Arm 2|Usual care
380900|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380901|NCT00435188|O2|Outcome|Arm 2|Usual care
380902|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380903|NCT00435188|O2|Outcome|Arm 2|Usual care
380904|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380905|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
380906|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380907|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
380908|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380909|NCT00435188|O2|Outcome|Arm 2|Usual care
380910|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
442784|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
380912|NCT00435188|E1|Reported Event|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
380913|NCT00435370|B3|Baseline|Total|Total of all reporting groups
380914|NCT00435370|B2|Baseline|Placebo|Placebo + risperidone (6mg/day)
380915|NCT00435370|B1|Baseline|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
380916|NCT00435370|P2|Participant Flow|Placebo|Placebo + risperidone (6mg/day)
380917|NCT00435370|P1|Participant Flow|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
380918|NCT00435370|O2|Outcome|Placebo|Placebo + risperidone (6mg/day)
380919|NCT00435370|O1|Outcome|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
380920|NCT00435370|E2|Reported Event|Placebo|Placebo + risperidone (6mg/day)
380921|NCT00435370|E1|Reported Event|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
380922|NCT00435409|B3|Baseline|Total|Total of all reporting groups
380923|NCT00435409|B2|Baseline|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
380924|NCT00435409|B1|Baseline|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
380925|NCT00435409|P3|Participant Flow|Capecitabine, Crossover to Sunitinib|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
380926|NCT00435409|P2|Participant Flow|Capecitabine, no Crossover|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks.
380927|NCT00435409|P1|Participant Flow|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 milligrams (mg) once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 milligrams per square meter (mg/m^2) per day (1000 mg/m^2 twice daily [BID]) from Days 1-14 every 3 weeks.
380928|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
380929|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
380930|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
380931|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
380932|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
380933|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
380934|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
380935|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
381000|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
384097|NCT00441480|E2|Reported Event|Control|Corn oil
380937|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
380938|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
380939|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
380940|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
380941|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
442785|NCT00594425|O3|Outcome|Vehicle PDT|
380942|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
380943|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
380944|NCT00435409|E2|Reported Event|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
380945|NCT00435409|E1|Reported Event|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
380946|NCT00435487|B3|Baseline|Total|Total of all reporting groups
380947|NCT00435487|B2|Baseline|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380948|NCT00435487|B1|Baseline|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380949|NCT00435487|P2|Participant Flow|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380950|NCT00435487|P1|Participant Flow|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380951|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380952|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380953|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380954|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380955|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380956|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380957|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380958|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
381001|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
380959|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380960|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380961|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380962|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
384932|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
380963|NCT00435487|E2|Reported Event|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380964|NCT00435487|E1|Reported Event|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
380965|NCT00435539|B6|Baseline|Total|Total of all reporting groups
380966|NCT00435539|B5|Baseline|Sham Injection|sham injection
380967|NCT00435539|B4|Baseline|Ocriplasmin 125µg Multiple Injections|ocriplasmin 125µg multiple injections Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
380968|NCT00435539|B3|Baseline|Ocriplasmin 175µg Single Injection|ocriplasmin 175µg single injection versus sham injection
380969|NCT00435539|B2|Baseline|Ocriplasmin 125µg Single Injection|ocriplasmin 125µg single injection versus sham injection
380970|NCT00435539|B1|Baseline|Ocriplasmin 75µg Single Injection|ocriplasmin 75µg single injection versus sham injection
380971|NCT00435539|P5|Participant Flow|Sham Injection|sham injection
380972|NCT00435539|P4|Participant Flow|Ocriplasmin 125µg Multiple Injections|ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
380973|NCT00435539|P3|Participant Flow|Ocriplasmin 175µg Single Injection|ocriplasmin 175µg single injection versus sham injection
380974|NCT00435539|P2|Participant Flow|Ocriplasmin 125µg Single Injection|ocriplasmin 125µg single injection versus sham injection
380975|NCT00435539|P1|Participant Flow|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
380976|NCT00435539|O4|Outcome|Sham Injection|sham injection
380977|NCT00435539|O3|Outcome|Ocriplasmin 125µg Pooled|Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection
380978|NCT00435539|O2|Outcome|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
380979|NCT00435539|O1|Outcome|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
380980|NCT00435539|O4|Outcome|Sham Injection|sham injection
380981|NCT00435539|O3|Outcome|Ocriplasmin 125µg Pooled|Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection
380982|NCT00435539|O2|Outcome|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
380983|NCT00435539|O1|Outcome|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
380984|NCT00435539|E5|Reported Event|Sham Injection|Sham injection
380985|NCT00435539|E4|Reported Event|Ocriplasmin 125µg Multiple Injection|Ocriplasmin 125µg multiple injection versus sham injection
380986|NCT00435539|E3|Reported Event|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
380987|NCT00435539|E2|Reported Event|Ocriplasmin 125µg Single Injection|Ocriplasmin 125µg single injection versus sham injection
380988|NCT00435539|E1|Reported Event|Ocriplasmin 75µg|Ocriplasmin 75µg single injection versus sham injection
380989|NCT00435591|B5|Baseline|Total|Total of all reporting groups
380990|NCT00435591|B4|Baseline|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
380991|NCT00435591|B3|Baseline|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
380992|NCT00435591|B2|Baseline|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
380993|NCT00435591|B1|Baseline|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
380994|NCT00435591|P4|Participant Flow|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
380995|NCT00435591|P3|Participant Flow|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
380996|NCT00435591|P2|Participant Flow|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
380997|NCT00435591|P1|Participant Flow|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
380998|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
380999|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
390905|NCT00460265|B3|Baseline|Total|Total of all reporting groups
381002|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20mg)+20mg/day continuous infusion conivaptan per premix bag
381003|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag
381004|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
381005|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
381006|NCT00435591|O1|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
381007|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
381008|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
381009|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
381010|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
381011|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
381014|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
381015|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
381016|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
381017|NCT00435591|E4|Reported Event|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
381018|NCT00435591|E3|Reported Event|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
381019|NCT00435591|E2|Reported Event|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
381020|NCT00435591|E1|Reported Event|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
381021|NCT00435825|B5|Baseline|Total|Total of all reporting groups
381022|NCT00435825|B4|Baseline|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381023|NCT00435825|B3|Baseline|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381024|NCT00435825|B2|Baseline|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381025|NCT00435825|B1|Baseline|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381026|NCT00435825|P4|Participant Flow|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381027|NCT00435825|P3|Participant Flow|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381028|NCT00435825|P2|Participant Flow|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381029|NCT00435825|P1|Participant Flow|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381030|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381031|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381032|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381033|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381034|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381035|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381036|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381037|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381038|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381039|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381040|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381041|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381042|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381043|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381044|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381045|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381046|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381047|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
391636|NCT00461292|B3|Baseline|Placebo|Normal saline (placebo)
381048|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381049|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381050|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381051|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381052|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381053|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381054|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381055|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381056|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381473|NCT00436969|B2|Baseline|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381057|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381058|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381059|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381060|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381061|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381062|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381063|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381064|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381065|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381066|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381067|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381068|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381069|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381070|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381071|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381072|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381073|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381074|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381075|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381076|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381077|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381078|NCT00435825|E4|Reported Event|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381079|NCT00435825|E3|Reported Event|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
381080|NCT00435825|E2|Reported Event|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381081|NCT00435825|E1|Reported Event|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
381082|NCT00435929|B3|Baseline|Total|Total of all reporting groups
381083|NCT00435929|B2|Baseline|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381084|NCT00435929|B1|Baseline|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381085|NCT00435929|P2|Participant Flow|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381086|NCT00435929|P1|Participant Flow|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381087|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381088|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
393622|NCT00469274|B3|Baseline|Total|Total of all reporting groups
381089|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381090|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381091|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381092|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381093|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381094|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381095|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381096|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381097|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381098|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381099|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381100|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381101|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381102|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381103|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381104|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381105|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381106|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381107|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381108|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381109|NCT00435929|E2|Reported Event|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
381110|NCT00435929|E1|Reported Event|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
381111|NCT00435994|B4|Baseline|Total|Total of all reporting groups
381112|NCT00435994|B3|Baseline|Bronchiolitis|Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
381113|NCT00435994|B2|Baseline|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
381114|NCT00435994|B1|Baseline|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
381115|NCT00435994|P3|Participant Flow|Bronchiolitis-Nasal Wash Only|Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
381116|NCT00435994|P2|Participant Flow|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
381117|NCT00435994|P1|Participant Flow|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
381118|NCT00435994|O2|Outcome|Bronchiolitis and Respiratory Syncytial Virus-Nasal Wash Only|Infants 2 months to 24 months who were diagnosed with bronchiolitis and respiratory syncytial virus received nasal wash only.
381119|NCT00435994|O1|Outcome|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
381120|NCT00435994|O2|Outcome|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
381121|NCT00435994|O1|Outcome|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity had spirometry performed under sedation.
381122|NCT00435994|E3|Reported Event|Bronchiolitis|
381123|NCT00435994|E2|Reported Event|Respiratory Syncytial Virus|
381124|NCT00435994|E1|Reported Event|Healthy Control|
381125|NCT00436007|B4|Baseline|Total|Total of all reporting groups
381517|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381126|NCT00436007|B3|Baseline|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381127|NCT00436007|B2|Baseline|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381477|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381128|NCT00436007|B1|Baseline|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381129|NCT00436007|P3|Participant Flow|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381130|NCT00436007|P2|Participant Flow|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381131|NCT00436007|P1|Participant Flow|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381132|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381133|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381134|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381135|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381181|NCT00436046|P1|Participant Flow|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
384098|NCT00441480|E1|Reported Event|PS-FO|plant sterols esterified to fish oil fatty acids
381136|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381137|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381138|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381139|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381140|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381141|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381142|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381143|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381144|NCT00436007|O1|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381145|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381182|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
381183|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
381146|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381147|NCT00436007|O2|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381148|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381149|NCT00436007|O2|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381150|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381151|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381152|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381153|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381154|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381155|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381184|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
383019|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
381156|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381157|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381158|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381159|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381160|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381161|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381162|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381163|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania
381164|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381165|NCT00436007|O1|Outcome|GSK 257049 1 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381185|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
381186|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
381166|NCT00436007|O1|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381167|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381168|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381169|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381170|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381171|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381172|NCT00436007|E3|Reported Event|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381173|NCT00436007|E2|Reported Event|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
381174|NCT00436007|E1|Reported Event|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.
The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
381175|NCT00436046|B4|Baseline|Total|Total of all reporting groups
381176|NCT00436046|B3|Baseline|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
381177|NCT00436046|B2|Baseline|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
381178|NCT00436046|B1|Baseline|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
381179|NCT00436046|P3|Participant Flow|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
381180|NCT00436046|P2|Participant Flow|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
384099|NCT00441545|B1|Baseline|Entire Study Population|
381187|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
381188|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
381189|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
381190|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
381191|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
381192|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
381193|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
442786|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
381194|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
381195|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
381196|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
381197|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
381198|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
381199|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
381200|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
381201|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
381202|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
381203|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
381204|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
381205|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
381206|NCT00436046|E3|Reported Event|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
381207|NCT00436046|E2|Reported Event|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
381208|NCT00436046|E1|Reported Event|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
381209|NCT00436163|B1|Baseline|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
381210|NCT00436163|P1|Participant Flow|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously once per week for 48 weeks.
381211|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
381212|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
381213|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
381214|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys)180 mcg subcutaneously once per week for 48 weeks.
381215|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys)180 mcg subcutaneously once per week for 48 weeks.
381216|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
381217|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
381218|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
381219|NCT00436163|E1|Reported Event|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
381220|NCT00436215|B1|Baseline|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
381221|NCT00436215|P1|Participant Flow|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
381222|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
381223|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
381224|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
394403|NCT00473824|B3|Baseline|Total|Total of all reporting groups
381225|NCT00436215|E1|Reported Event|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
381226|NCT00436332|B1|Baseline|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
381227|NCT00436332|P1|Participant Flow|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
381228|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
381229|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
381230|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
381231|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
381232|NCT00436332|E1|Reported Event|Erlotinib and Bevacizumab|Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1.
381233|NCT00436345|B3|Baseline|Total|Total of all reporting groups
381234|NCT00436345|B2|Baseline|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381235|NCT00436345|B1|Baseline|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381236|NCT00436345|P2|Participant Flow|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381237|NCT00436345|P1|Participant Flow|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381238|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381239|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381240|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381241|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381242|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381243|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381244|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381245|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381246|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per killograms per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381247|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381518|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
383020|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
381248|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381249|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381250|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
442787|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
381251|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381252|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381253|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381254|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381255|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381256|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381257|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381258|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381259|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381260|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381261|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381262|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381263|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381264|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381265|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381519|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381520|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381266|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381267|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381268|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381269|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381270|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381271|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381272|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381273|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381274|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381275|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381276|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381277|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381278|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381279|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381280|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381281|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381282|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381283|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381521|NCT00436969|E2|Reported Event|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381522|NCT00436969|E1|Reported Event|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone).
381284|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381285|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381286|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381287|NCT00436345|E2|Reported Event|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
381288|NCT00436345|E1|Reported Event|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
381289|NCT00436436|B1|Baseline|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide"
381290|NCT00436436|P1|Participant Flow|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide"
381291|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide"
381292|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide"
381293|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide"
381294|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide"
381295|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide"
381296|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide"
381297|NCT00436436|E1|Reported Event|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide"
381298|NCT00436501|B3|Baseline|Total|Total of all reporting groups
381299|NCT00436501|B2|Baseline|Phase II VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
381300|NCT00436501|B1|Baseline|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
381301|NCT00436501|P2|Participant Flow|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
381302|NCT00436501|P1|Participant Flow|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
381303|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
381304|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
381305|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
381306|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
381307|NCT00436501|O2|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
381308|NCT00436501|O1|Outcome|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
381309|NCT00436501|O1|Outcome|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
381310|NCT00436501|E2|Reported Event|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
381311|NCT00436501|E1|Reported Event|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
381312|NCT00436553|B4|Baseline|Total|Total of all reporting groups
381474|NCT00436969|B1|Baseline|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381313|NCT00436553|B3|Baseline|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
381314|NCT00436553|B2|Baseline|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381315|NCT00436553|B1|Baseline|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381316|NCT00436553|P3|Participant Flow|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
381317|NCT00436553|P2|Participant Flow|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381318|NCT00436553|P1|Participant Flow|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381319|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381523|NCT00436982|B3|Baseline|Total|Total of all reporting groups
381320|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
384933|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
381321|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
381322|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381323|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381324|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
381325|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381326|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381327|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
381336|NCT00436566|B1|Baseline|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
381328|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
442788|NCT00594425|O3|Outcome|Vehicle PDT|
381329|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381330|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
381331|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381332|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381333|NCT00436553|E3|Reported Event|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
381334|NCT00436553|E2|Reported Event|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381335|NCT00436553|E1|Reported Event|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
381524|NCT00436982|B2|Baseline|Duracon|30 patients randomized into the Duracon arm
381525|NCT00436982|B1|Baseline|Triathlon|30 patients randomized into the Triathlon arm
381337|NCT00436566|P1|Participant Flow|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
381338|NCT00436566|O1|Outcome|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
381475|NCT00436969|P2|Participant Flow|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381339|NCT00436566|E1|Reported Event|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
381340|NCT00436605|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
381341|NCT00436605|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
381342|NCT00436605|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
381343|NCT00436605|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
381344|NCT00436605|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
381345|NCT00436618|B4|Baseline|Total|Total of all reporting groups
381346|NCT00436618|B3|Baseline|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381347|NCT00436618|B2|Baseline|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381348|NCT00436618|B1|Baseline|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381349|NCT00436618|P3|Participant Flow|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381350|NCT00436618|P2|Participant Flow|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381351|NCT00436618|P1|Participant Flow|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381352|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381353|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381354|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381355|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381356|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381357|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381358|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381359|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381360|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
442789|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
381361|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381362|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381363|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381364|NCT00436618|E3|Reported Event|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381365|NCT00436618|E2|Reported Event|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381366|NCT00436618|E1|Reported Event|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
381367|NCT00436644|B1|Baseline|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
381368|NCT00436644|P1|Participant Flow|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
381369|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
381370|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
381371|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
381372|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
381373|NCT00436644|E1|Reported Event|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
381374|NCT00436748|B3|Baseline|Total|Total of all reporting groups
381375|NCT00436748|B2|Baseline|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381376|NCT00436748|B1|Baseline|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381377|NCT00436748|P2|Participant Flow|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381378|NCT00436748|P1|Participant Flow|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381379|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381628|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381380|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381476|NCT00436969|P1|Participant Flow|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
442790|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
381381|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381382|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381383|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381384|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381385|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381386|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381387|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381388|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381389|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381390|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381391|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381392|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381393|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381648|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381394|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381395|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381396|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381397|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381398|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381399|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381400|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381401|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381402|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381403|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381404|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381405|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381406|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381407|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381668|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381408|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381409|NCT00436748|E2|Reported Event|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381410|NCT00436748|E1|Reported Event|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
381411|NCT00436826|B3|Baseline|Total|Total of all reporting groups
381412|NCT00436826|B2|Baseline|Placebo, IFN-beta|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks. After completing DB period, participants entered in OL extension period. In OL extension period, participant who met eligibility criteria received OL oral cladribine 3.5 mg/kg and participants participants who did not meet the eligibility criteria received IFN-beta only and were followed for safety only.
381413|NCT00436826|B1|Baseline|Cladribine 3.5 mg/kg, IFN-beta|Participants received cladribine tablets orally as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks. After completing DB period, participants entered in OL extension period. In OL extension period, participant who met eligibility criteria received OL oral cladribine 3.5 mg/kg and participants who did not meet the eligibility criteria received IFN-beta only and were followed for safety only.
381414|NCT00436826|P6|Participant Flow|Placebo, IFN-beta (Safety Follow up)|Participants who received placebo initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
381415|NCT00436826|P5|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta (Safety Follow up)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
381416|NCT00436826|P4|Participant Flow|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
381417|NCT00436826|P3|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
381418|NCT00436826|P2|Participant Flow|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381419|NCT00436826|P1|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks.
381420|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381421|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381469|NCT00436956|O1|Outcome|All Participants- AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
381422|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
442791|NCT00594425|O3|Outcome|Vehicle PDT|
381423|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381424|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381425|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381426|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381427|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381428|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381429|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381430|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381431|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381432|NCT00436826|E6|Reported Event|Placebo, IFN-beta (Safety Follow up)|Participants who received placebo initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
381433|NCT00436826|E5|Reported Event|Cladribine 3.5 mg/kg, IFN-beta (Safety Follow up)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
381434|NCT00436826|E4|Reported Event|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
381435|NCT00436826|E3|Reported Event|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
381436|NCT00436826|E2|Reported Event|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381470|NCT00436956|O1|Outcome|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
381437|NCT00436826|E1|Reported Event|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
381439|NCT00436852|B2|Baseline|Measurable Disease by CT or MRI Scan (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
381440|NCT00436852|B1|Baseline|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
381441|NCT00436852|P2|Participant Flow|Measurable Disease by CT or MRI Scan (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
381442|NCT00436852|P1|Participant Flow|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
381443|NCT00436852|O2|Outcome|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
381444|NCT00436852|O1|Outcome|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
381445|NCT00436852|O2|Outcome|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
381446|NCT00436852|O1|Outcome|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
381447|NCT00436852|E2|Reported Event|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
381448|NCT00436852|E1|Reported Event|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
381449|NCT00436904|B1|Baseline|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
381450|NCT00436904|P1|Participant Flow|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
381451|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
381452|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
381453|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
381454|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
381455|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
381456|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
381457|NCT00436904|E1|Reported Event|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
381458|NCT00436917|B1|Baseline|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
381459|NCT00436917|P1|Participant Flow|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
381460|NCT00436917|O1|Outcome|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
381461|NCT00436917|E1|Reported Event|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
381462|NCT00436956|B1|Baseline|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
381463|NCT00436956|P2|Participant Flow|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
381464|NCT00436956|P1|Participant Flow|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
381465|NCT00436956|O2|Outcome|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
381466|NCT00436956|O1|Outcome|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
381467|NCT00436956|O2|Outcome|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
381468|NCT00436956|O1|Outcome|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
381516|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
384839|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
381471|NCT00436956|E1|Reported Event|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
381472|NCT00436969|B3|Baseline|Total|Total of all reporting groups
442792|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
381478|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381479|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381480|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381481|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381482|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381483|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381484|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381485|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381486|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381487|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381488|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381489|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381490|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381491|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381492|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381493|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381494|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381495|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381496|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381497|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381498|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381499|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381500|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381501|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381502|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381503|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381504|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381505|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381506|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381507|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381508|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381509|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381510|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381511|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381512|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381513|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381514|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
381515|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
381526|NCT00436982|P2|Participant Flow|Duracon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Duracon total knee system: Orthopaedic implant"
381527|NCT00436982|P1|Participant Flow|Cemented Triathlon Total Knee System|"30 patients were randomized into the Triathlon total knee system arm. TheTriathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Cemented Triathlon total knee system: Orthopaedic implant"
381528|NCT00436982|O2|Outcome|Duracon|30 patients randomized into the Duracon arm
381529|NCT00436982|O1|Outcome|Triathlon|30 patients randomized into the Triathlon arm
381530|NCT00436982|E2|Reported Event|Duracon|30 patients randomized into the Duracon arm
381531|NCT00436982|E1|Reported Event|Triathlon|30 patients randomized into the Triathlon arm
382322|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
381532|NCT00437034|B1|Baseline|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
aflibercept: Given IV"
381533|NCT00437034|P1|Participant Flow|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
aflibercept: Given IV"
381534|NCT00437034|O1|Outcome|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
aflibercept: Given IV"
381535|NCT00437034|E1|Reported Event|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
aflibercept: Given IV"
381536|NCT00437073|B3|Baseline|Total|Total of all reporting groups
381537|NCT00437073|B2|Baseline|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381538|NCT00437073|B1|Baseline|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381539|NCT00437073|P2|Participant Flow|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381540|NCT00437073|P1|Participant Flow|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381541|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381542|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381543|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381544|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381545|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381546|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
382058|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
381547|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381548|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
382533|NCT00430755|E1|Reported Event|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
381549|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381550|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381551|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381552|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381553|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381554|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381555|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381556|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381557|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381558|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381559|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381560|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381561|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
383021|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
381562|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381563|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381564|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381565|NCT00437073|E2|Reported Event|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
381566|NCT00437073|E1|Reported Event|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
381567|NCT00437125|B1|Baseline|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381568|NCT00437125|P1|Participant Flow|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381569|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381570|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381571|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381572|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381573|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381574|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381575|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381576|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381577|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381578|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381579|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381580|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381581|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381582|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381583|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381584|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381585|NCT00437125|E1|Reported Event|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
381586|NCT00437203|B11|Baseline|Total|Total of all reporting groups
381587|NCT00437203|B10|Baseline|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381588|NCT00437203|B9|Baseline|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381589|NCT00437203|B8|Baseline|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
382059|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
381590|NCT00437203|B7|Baseline|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381591|NCT00437203|B6|Baseline|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
382534|NCT00430768|B4|Baseline|Total|Total of all reporting groups
381592|NCT00437203|B5|Baseline|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381593|NCT00437203|B4|Baseline|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381594|NCT00437203|B3|Baseline|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381595|NCT00437203|B2|Baseline|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381596|NCT00437203|B1|Baseline|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381597|NCT00437203|P10|Participant Flow|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381598|NCT00437203|P9|Participant Flow|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381599|NCT00437203|P8|Participant Flow|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381600|NCT00437203|P7|Participant Flow|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381601|NCT00437203|P6|Participant Flow|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381602|NCT00437203|P5|Participant Flow|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381603|NCT00437203|P4|Participant Flow|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381604|NCT00437203|P3|Participant Flow|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381605|NCT00437203|P2|Participant Flow|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381606|NCT00437203|P1|Participant Flow|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 milligram (mg) 3 hours (hrs) infusion intravenously (IV) on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg per square meter (mg/m^2) 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381607|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381608|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
383022|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
381609|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381610|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381611|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381612|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381613|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381614|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381615|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381616|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381617|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381618|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381619|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381620|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381621|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381622|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381623|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381624|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381625|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381626|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381627|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
382674|NCT00431444|E1|Reported Event|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
381629|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381630|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381631|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381632|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381633|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381634|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381635|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381636|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381637|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381638|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381639|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381640|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381641|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381642|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381643|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381644|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381645|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381646|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381647|NCT00437203|O7|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
382675|NCT00437645|B3|Baseline|Total|Total of all reporting groups
395359|NCT00475306|B5|Baseline|Total|Total of all reporting groups
381649|NCT00437203|O5|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381650|NCT00437203|O4|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381651|NCT00437203|O3|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381652|NCT00437203|O2|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381653|NCT00437203|O1|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381654|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381655|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381656|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381657|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381658|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381659|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381660|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381661|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381662|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381663|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381664|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381665|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381666|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381667|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
382967|NCT00439608|E1|Reported Event|Treatment|Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
381669|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381670|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381671|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381672|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381673|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381674|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381675|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381676|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381677|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381678|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381679|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381680|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381681|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381682|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381683|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381684|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381685|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381686|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381687|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
382968|NCT00439647|B3|Baseline|Total|Total of all reporting groups
395599|NCT00475865|B4|Baseline|Total|Total of all reporting groups
381688|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381689|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
382323|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
381690|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381691|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381692|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381693|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381694|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381695|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381696|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381697|NCT00437203|O2|Outcome|PF-00477736 + Gemcitabine 1000 mg/m^2|PF-00477736 infusion 180 mg or 225 mg IV administered over 24 hrs on Days 2 and 9 of each cycle (21 days cycle) along with gemcitabine infusion 1000 mg/m^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381698|NCT00437203|O1|Outcome|PF-00477736 + Gemcitabine 750 mg/m^2|PF-00477736 infusion 50 mg, 65 mg or 80 mg IV administered over 3 hrs on Days 1 and 8 of Cycle 0 (21 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle), or PF-00477736 infusion 80 mg, 120 mg, 180 mg, 270 mg or 340 mg IV administered over 24 hrs on Days 1 and 8 of Cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 750 mg/m^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381699|NCT00437203|E10|Reported Event|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381700|NCT00437203|E9|Reported Event|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
381701|NCT00437203|E8|Reported Event|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381702|NCT00437203|E7|Reported Event|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381703|NCT00437203|E6|Reported Event|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381704|NCT00437203|E5|Reported Event|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381705|NCT00437203|E4|Reported Event|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381706|NCT00437203|E3|Reported Event|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
382319|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
381707|NCT00437203|E2|Reported Event|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
382324|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
381708|NCT00437203|E1|Reported Event|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
381709|NCT00437281|B21|Baseline|Total|Total of all reporting groups
381710|NCT00437281|B20|Baseline|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381711|NCT00437281|B19|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381712|NCT00437281|B18|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381713|NCT00437281|B17|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381714|NCT00437281|B16|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381715|NCT00437281|B15|Baseline|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381716|NCT00437281|B14|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381717|NCT00437281|B13|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381718|NCT00437281|B12|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381719|NCT00437281|B11|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381720|NCT00437281|B10|Baseline|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381721|NCT00437281|B9|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381722|NCT00437281|B8|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381723|NCT00437281|B7|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381724|NCT00437281|B6|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
442793|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
381725|NCT00437281|B5|Baseline|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381726|NCT00437281|B4|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381727|NCT00437281|B3|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381728|NCT00437281|B2|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381729|NCT00437281|B1|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381730|NCT00437281|P20|Participant Flow|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381731|NCT00437281|P19|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381732|NCT00437281|P18|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381733|NCT00437281|P17|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381734|NCT00437281|P16|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381735|NCT00437281|P15|Participant Flow|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381736|NCT00437281|P14|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381737|NCT00437281|P13|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381738|NCT00437281|P12|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381739|NCT00437281|P11|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382360|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
381740|NCT00437281|P10|Participant Flow|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381741|NCT00437281|P9|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381742|NCT00437281|P8|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381743|NCT00437281|P7|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381744|NCT00437281|P6|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381745|NCT00437281|P5|Participant Flow|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381746|NCT00437281|P4|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381747|NCT00437281|P3|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381748|NCT00437281|P2|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381749|NCT00437281|P1|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381750|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381751|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381752|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381753|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381754|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381755|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382361|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
381756|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381757|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381758|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381759|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381760|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381761|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381762|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381763|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381764|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381765|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381766|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381767|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381768|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381769|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381770|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381771|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382060|NCT00437489|E2|Reported Event|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
396088|NCT00467285|E1|Reported Event|Pioglitazone|Subjects on pioglitazone
381772|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381773|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381774|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381775|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381776|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381777|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381778|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381779|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381780|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381781|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381782|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381783|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381784|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381785|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381786|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381787|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381788|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381789|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381790|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381791|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381792|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381793|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381794|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381795|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381796|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381797|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381798|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381799|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381800|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381801|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381802|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381803|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381804|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382061|NCT00437489|E1|Reported Event|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
382062|NCT00430248|B4|Baseline|Total|Total of all reporting groups
381805|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
442794|NCT00594425|O3|Outcome|Vehicle PDT|
381806|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381807|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381808|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381809|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381810|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381811|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381812|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381813|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381814|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381815|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381816|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381817|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381818|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381819|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381820|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381821|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381822|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381823|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381824|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381825|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381826|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381827|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381828|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381829|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381830|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381831|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381832|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381833|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381834|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381835|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381836|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381837|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382063|NCT00430248|B3|Baseline|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
381838|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381839|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381840|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381841|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381842|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381843|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381844|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381845|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381846|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381847|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381848|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381849|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381850|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381851|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381852|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381853|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381854|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381855|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381856|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381857|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381858|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381859|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381860|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381861|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381862|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381863|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381864|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381865|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381866|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381867|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381868|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381869|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381870|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382064|NCT00430248|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382065|NCT00430248|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382362|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|145 females participants were analyzed.
381871|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381872|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381873|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381874|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381875|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381876|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381877|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381878|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381879|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381880|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381881|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381882|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381883|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381884|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381885|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381886|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381887|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381888|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381889|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381890|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381891|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381892|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381893|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381894|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381895|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381896|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381897|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381898|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381899|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381900|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381901|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381902|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381903|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382066|NCT00430248|P3|Participant Flow|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382363|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
381904|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381905|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381906|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381907|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381908|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381909|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381910|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381911|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381912|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381913|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381914|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381915|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381916|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381917|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381918|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381919|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381920|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382072|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382073|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
381921|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381922|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381923|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381924|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381925|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381926|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381927|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381928|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381929|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381930|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381931|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381932|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381933|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381934|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381935|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381936|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382067|NCT00430248|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382068|NCT00430248|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
384840|NCT00445432|O1|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
381937|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381938|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381939|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381940|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381941|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381942|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381943|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381944|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381945|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381946|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381947|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381948|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381949|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381950|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381951|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381952|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382069|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382070|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
381953|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381954|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381955|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381956|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381957|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381958|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381959|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381960|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381961|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381962|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381963|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381964|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381965|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381966|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381967|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381968|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382071|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
396089|NCT00467363|B3|Baseline|Total|Total of all reporting groups
381969|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381970|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381971|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381972|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381973|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381974|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381975|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381976|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381977|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381978|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381979|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381980|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381981|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381982|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381983|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381984|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382112|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382113|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
381985|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381986|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381987|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381988|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381989|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381990|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381991|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381992|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381993|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381994|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381995|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381996|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381997|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381998|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
381999|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382000|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382245|NCT00430352|E1|Reported Event|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382001|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382002|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382003|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382004|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382005|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382006|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382007|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382008|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382009|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382010|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382011|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382012|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382013|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382014|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382015|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382016|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382246|NCT00430495|B5|Baseline|Total|Total of all reporting groups
384841|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
382017|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382018|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382019|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382020|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382021|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382022|NCT00437281|E20|Reported Event|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382023|NCT00437281|E19|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382024|NCT00437281|E18|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382025|NCT00437281|E17|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382026|NCT00437281|E16|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382027|NCT00437281|E15|Reported Event|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382028|NCT00437281|E14|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382029|NCT00437281|E13|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382030|NCT00437281|E12|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382031|NCT00437281|E11|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382032|NCT00437281|E10|Reported Event|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
383015|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
382033|NCT00437281|E9|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382034|NCT00437281|E8|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382035|NCT00437281|E7|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382036|NCT00437281|E6|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382037|NCT00437281|E5|Reported Event|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382038|NCT00437281|E4|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382039|NCT00437281|E3|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382040|NCT00437281|E2|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382041|NCT00437281|E1|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
382042|NCT00437398|B1|Baseline|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
382043|NCT00437398|P1|Participant Flow|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
382044|NCT00437398|O1|Outcome|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
382045|NCT00437398|O1|Outcome|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
382046|NCT00437398|E1|Reported Event|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
382047|NCT00437489|B3|Baseline|Total|Total of all reporting groups
382048|NCT00437489|B2|Baseline|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
382049|NCT00437489|B1|Baseline|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
382050|NCT00437489|P2|Participant Flow|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
382051|NCT00437489|P1|Participant Flow|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
382052|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
382053|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
382054|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
382055|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
382056|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
382057|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
383016|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
382075|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382076|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382077|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382078|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382079|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382080|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382081|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382082|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382083|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382084|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382085|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382086|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382087|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382088|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382089|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382090|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382091|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382092|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382093|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382094|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382095|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382096|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382097|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382098|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382099|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382100|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382101|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382102|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382103|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382104|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382105|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382106|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382107|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382108|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382109|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382110|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382111|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382114|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382115|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382116|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382117|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382118|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382119|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382120|NCT00430248|E3|Reported Event|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
382121|NCT00430248|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
382122|NCT00430248|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
382123|NCT00430300|B5|Baseline|Total|Total of all reporting groups
382124|NCT00430300|B4|Baseline|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382125|NCT00430300|B3|Baseline|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382126|NCT00430300|B2|Baseline|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382127|NCT00430300|B1|Baseline|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382128|NCT00430300|P4|Participant Flow|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382129|NCT00430300|P3|Participant Flow|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382130|NCT00430300|P2|Participant Flow|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382131|NCT00430300|P1|Participant Flow|UK-432,097 150 Mcg|UK-432,097 150 microgram (mcg) capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide metered dose inhaler (MDI) 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382132|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382133|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382134|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382135|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382136|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382137|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382535|NCT00430768|B3|Baseline|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg
Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg"
382138|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382139|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382140|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382141|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382142|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382143|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382144|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382145|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382146|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382147|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382148|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382149|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382150|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382151|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382152|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382153|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
397150|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily
382154|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382155|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382156|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382157|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382158|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382159|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382160|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382161|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382162|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382163|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382164|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382165|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382166|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382167|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382168|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382169|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382170|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
397458|NCT00477269|O1|Outcome|STI571|STI571
382171|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382172|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382173|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382174|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382175|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382176|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382177|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382178|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382179|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382180|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382181|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382182|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382183|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382184|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382185|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382186|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382187|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
397459|NCT00477269|O2|Outcome|Placebo|Placebo
382188|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382189|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382190|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382191|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382192|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382193|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382194|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382195|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382196|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382197|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382198|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382199|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382200|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382201|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382202|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382203|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382204|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
397460|NCT00477269|O1|Outcome|STI571|STI571
382205|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382206|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382207|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382208|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382209|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382210|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382211|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382212|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382213|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382214|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382215|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382216|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382217|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382218|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382219|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382220|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382221|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
397461|NCT00477269|O1|Outcome|All Patients|Open label extension
382222|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382223|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382224|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382225|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382226|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382227|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382228|NCT00430300|E4|Reported Event|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382229|NCT00430300|E3|Reported Event|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382230|NCT00430300|E2|Reported Event|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382231|NCT00430300|E1|Reported Event|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
382232|NCT00430352|B1|Baseline|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382233|NCT00430352|P1|Participant Flow|Rituximab 375 Milligrams Per Square Meter (mg/m^2)|Participants received rituximab 375 mg/m^2 intravenously (IV) once every 8 weeks for a total 12 infusions until progression, relapse, start of a new treatment, death, or toxicity.
382234|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382235|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382236|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382237|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382238|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382239|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382240|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382241|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382242|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382243|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382244|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
382247|NCT00430495|B4|Baseline|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
382248|NCT00430495|B3|Baseline|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
382249|NCT00430495|B2|Baseline|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
382250|NCT00430495|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
382251|NCT00430495|P4|Participant Flow|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
382252|NCT00430495|P3|Participant Flow|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
382253|NCT00430495|P2|Participant Flow|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
382254|NCT00430495|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
382255|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
382256|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
382257|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
382258|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
382259|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
382260|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
382261|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
382262|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
382263|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
382264|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
382265|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
382266|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
382267|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
382268|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
382269|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
382270|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
382271|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
382272|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
382273|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
382274|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
382275|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
382276|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
382277|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
382278|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
382279|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
382280|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
382281|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
382282|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
442795|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
382283|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
382284|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
382285|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
382286|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
382287|NCT00430495|E4|Reported Event|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
382288|NCT00430495|E3|Reported Event|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
382289|NCT00430495|E2|Reported Event|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
382290|NCT00430495|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
382291|NCT00430508|B5|Baseline|Total|Total of all reporting groups
382292|NCT00430508|B4|Baseline|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
382293|NCT00430508|B3|Baseline|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
382294|NCT00430508|B2|Baseline|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
382295|NCT00430508|B1|Baseline|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
382296|NCT00430508|P4|Participant Flow|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
382297|NCT00430508|P3|Participant Flow|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
382298|NCT00430508|P2|Participant Flow|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
382299|NCT00430508|P1|Participant Flow|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
382300|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382301|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
382302|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382303|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382304|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382305|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
382306|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382307|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382308|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382309|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
382310|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382311|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382312|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382313|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
382314|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382315|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382316|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382317|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
382318|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382320|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382321|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
382325|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
382326|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382327|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382328|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382329|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
382330|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382331|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
382332|NCT00430625|B3|Baseline|Total|Total of all reporting groups
382333|NCT00430625|B2|Baseline|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382334|NCT00430625|B1|Baseline|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382335|NCT00430625|P2|Participant Flow|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382336|NCT00430625|P1|Participant Flow|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382337|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382338|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382339|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382340|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382341|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382342|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382343|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382344|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382345|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382346|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382347|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382348|NCT00430625|O1|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382349|NCT00430625|E2|Reported Event|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382350|NCT00430625|E1|Reported Event|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
382351|NCT00430638|B3|Baseline|Total|Total of all reporting groups
382352|NCT00430638|B2|Baseline|Placebo Group|Participants were randomized to a placebo (Pbo) group. The Pbo participants remained in the pbo group for the entire 12 weeks of treatment.
382353|NCT00430638|B1|Baseline|Olmesartan Group|Participants were randomized to an olmesartan (Olm) based active treatment group. After 3,6,and 9 weeks of treatment participants were titrated to the next regiment if their blood pressure was greater than 120/80 mmHg. The active treatment group received olm 20 mg (weeks 1-3), olm 40 mg (weeks 4-6), olm 40 mg + 12.5 mg hydrchlorothiazide (HCTZ) (weeks 7-9), and olm 40 mg + 25 mg HCTZ (weeks 10-12).
382354|NCT00430638|P2|Participant Flow|Olmesartan Group|140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
382355|NCT00430638|P1|Participant Flow|Placebo (Pbo) Group|138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.
382356|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
382357|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
382358|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
382359|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
382364|NCT00430638|O2|Outcome|Olmesartan Group|Participants received olmesartan medoxomil tablets + hydrochlorothiazide tablets, if necessary, once daily for the duration of the 12-week active treatment period.
382365|NCT00430638|O1|Outcome|Placebo Group|Patient received placebo tablets throughout the 12-week active treatment period.
382366|NCT00430638|O2|Outcome|Olmesartan Group|Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
382367|NCT00430638|O1|Outcome|Placebo|Patient received placebo tablets.
382403|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382536|NCT00430768|B2|Baseline|Group 2 Middle Dose|"2.1 x 10e13 vector genomes
Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg"
382368|NCT00430638|E2|Reported Event|Olmesartan Group|140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
382369|NCT00430638|E1|Reported Event|Placebo (Pbo) Group|138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.
382370|NCT00430677|B4|Baseline|Total|Total of all reporting groups
382371|NCT00430677|B3|Baseline|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382372|NCT00430677|B2|Baseline|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382373|NCT00430677|B1|Baseline|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382374|NCT00430677|P3|Participant Flow|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382375|NCT00430677|P2|Participant Flow|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382376|NCT00430677|P1|Participant Flow|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382377|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382378|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382379|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382380|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382381|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382382|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382383|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382584|NCT00430937|P2|Participant Flow|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
382384|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382404|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382385|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382386|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382387|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
382388|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) Short-term period: by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
382389|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
382390|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
382391|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
382392|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
382393|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
382394|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382395|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382396|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382397|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382398|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382399|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382400|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382401|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382402|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382405|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382406|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382407|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382408|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382409|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382410|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382411|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382412|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382413|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382414|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382415|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382416|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382417|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382418|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382419|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382420|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382421|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382422|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382423|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382424|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382425|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382426|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382427|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382428|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382429|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382430|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382431|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382432|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382433|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382434|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382435|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382436|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382437|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382438|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382439|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382440|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382441|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382442|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382443|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382444|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382445|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382446|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382447|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382448|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382449|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382450|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382451|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382585|NCT00430937|P1|Participant Flow|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
382452|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382453|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382454|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382455|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382456|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382457|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382458|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382459|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382460|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382461|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382462|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382463|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382464|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382465|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382466|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382467|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382468|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382469|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382470|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382471|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382472|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382473|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382474|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382475|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382476|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
384842|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
382477|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382478|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382479|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382480|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382481|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382482|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382483|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382484|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382485|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382486|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382487|NCT00430677|O3|Outcome|Placebo|Placebo (dextrose 5% in water) or normal saline by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382488|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycofenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
382489|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382490|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382491|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382492|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
382493|NCT00430677|E3|Reported Event|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
382494|NCT00430677|E2|Reported Event|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: Participants received abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent.
382495|NCT00430677|E1|Reported Event|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: In the double-blind period, participants received abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57. In the open-label period, participants received abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
382496|NCT00430716|B4|Baseline|Total|Total of all reporting groups
382497|NCT00430716|B3|Baseline|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
382498|NCT00430716|B2|Baseline|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382499|NCT00430716|B1|Baseline|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382500|NCT00430716|P3|Participant Flow|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
382501|NCT00430716|P2|Participant Flow|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382672|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382502|NCT00430716|P1|Participant Flow|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382503|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
382504|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382505|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382506|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
382507|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382508|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382509|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
382510|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382511|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382512|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
382513|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382514|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382515|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
382516|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382517|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382518|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
382519|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382520|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382521|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
382522|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382523|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382524|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
382525|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382526|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382527|NCT00430716|E3|Reported Event|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
382528|NCT00430716|E2|Reported Event|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382529|NCT00430716|E1|Reported Event|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
382530|NCT00430755|B1|Baseline|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
382531|NCT00430755|P1|Participant Flow|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
382532|NCT00430755|O1|Outcome|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
442796|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
382537|NCT00430768|B1|Baseline|Group 1 Low Dose|"6.9 x10e12 vector genomes
Group 1 receives rAAV1-CB-hAAT 6.9 x1012 vg (vector genomes), e"
382538|NCT00430768|P3|Participant Flow|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg
Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg"
382539|NCT00430768|P2|Participant Flow|Group 2 Middle Dose|"2.1 x 10e13 vector genomes; 2.2 x 10e13 vector genomes
Group 2, 1 subject received rAAV1-CB-hAAT 2.1 x10e13 vg; 202 and 203 received rAAV1-CB-hAAT 2.2 x10e13 vg"
382540|NCT00430768|P1|Participant Flow|Group 1 Low Dose|"6.9 x10e12 vector genomes (vg)
Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg."
382541|NCT00430768|O6|Outcome|303 (High Dose)|Subject 303 M-specific AAT Level
382542|NCT00430768|O5|Outcome|302 (High Dose)|Subject 302 M-specific AAT Level
382543|NCT00430768|O4|Outcome|301 (High Dose)|Subject 301M-specific AAT Level
382544|NCT00430768|O3|Outcome|203 (Medium Dose)|Subject 203 M-specific AAT Level
382545|NCT00430768|O2|Outcome|202 (Medium Dose)|Subject 202 M-specific AAT Level
382546|NCT00430768|O1|Outcome|201 (Medium Dose)|Subject 201 M-specific AAT Level
382547|NCT00430768|O3|Outcome|Group 3 High Dose|
382548|NCT00430768|O2|Outcome|Group 2 Middle Dose|
382549|NCT00430768|O1|Outcome|Group 1 Low Dose|
382550|NCT00430768|E3|Reported Event|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg
Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg"
382551|NCT00430768|E2|Reported Event|Group 2 Middle Dose|"2.2 x 10e13 vector genomes
Group 2 receives rAAV1-CB-hAAT 2.1 x10e13 vg"
382552|NCT00430768|E1|Reported Event|Group 1 Low Dose|"6.9 x10e12 vector genomes
e. Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg (vector genomes)"
382553|NCT00430781|B4|Baseline|Total|Total of all reporting groups
382554|NCT00430781|B3|Baseline|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
382555|NCT00430781|B2|Baseline|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
382556|NCT00430781|B1|Baseline|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
382557|NCT00430781|P3|Participant Flow|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
382558|NCT00430781|P2|Participant Flow|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
382559|NCT00430781|P1|Participant Flow|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
382560|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
382561|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
382562|NCT00430781|O3|Outcome|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
382563|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
382564|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
382565|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
382566|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
382567|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
382568|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
382569|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
382570|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
382571|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
382572|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
382573|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
382574|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
382575|NCT00430781|O3|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
382576|NCT00430781|O2|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
382577|NCT00430781|O1|Outcome|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
382578|NCT00430781|E3|Reported Event|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
382579|NCT00430781|E2|Reported Event|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
382580|NCT00430781|E1|Reported Event|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
382581|NCT00430937|B3|Baseline|Total|Total of all reporting groups
382582|NCT00430937|B2|Baseline|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
382583|NCT00430937|B1|Baseline|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
382673|NCT00431444|E2|Reported Event|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382586|NCT00430937|O2|Outcome|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
382587|NCT00430937|O1|Outcome|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
382588|NCT00430937|O2|Outcome|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
382589|NCT00430937|O1|Outcome|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
382590|NCT00430937|E2|Reported Event|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
382591|NCT00430937|E1|Reported Event|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
382592|NCT00430950|B3|Baseline|Total|Total of all reporting groups
382593|NCT00430950|B2|Baseline|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
382594|NCT00430950|B1|Baseline|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
382595|NCT00430950|P2|Participant Flow|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
382596|NCT00430950|P1|Participant Flow|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
382597|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
382598|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
382599|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
382600|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
382601|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
382602|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
382603|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
382604|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
382605|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
382606|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
382607|NCT00430950|E2|Reported Event|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
382608|NCT00430950|E1|Reported Event|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
382609|NCT00431041|B3|Baseline|Total|Total of all reporting groups
382610|NCT00431041|B2|Baseline|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
382611|NCT00431041|B1|Baseline|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
382612|NCT00431041|P2|Participant Flow|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
382613|NCT00431041|P1|Participant Flow|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
382614|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
382615|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
382616|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
382617|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
382618|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
382619|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
382620|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
382621|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
382622|NCT00431041|E2|Reported Event|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
382623|NCT00431041|E1|Reported Event|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
382624|NCT00431067|B1|Baseline|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
382625|NCT00431067|P1|Participant Flow|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
382626|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
382627|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
382628|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
382629|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
382630|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
382631|NCT00431067|E1|Reported Event|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
382632|NCT00431132|B1|Baseline|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
382633|NCT00431132|P1|Participant Flow|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
382634|NCT00431132|O1|Outcome|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
382635|NCT00431132|O1|Outcome|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
382636|NCT00431132|E1|Reported Event|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
382637|NCT00431184|B3|Baseline|Total|Total of all reporting groups
442797|NCT00594425|O3|Outcome|Vehicle PDT|
382638|NCT00431184|B2|Baseline|Lorazepam Then Pentazocine|In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
382639|NCT00431184|B1|Baseline|Pentazocine Then Lorazepam|In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
382640|NCT00431184|P2|Participant Flow|Lorazepam Then Pentazocine|In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
382641|NCT00431184|P1|Participant Flow|Pentazocine Then Lorazepam|In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
382642|NCT00431184|O2|Outcome|Lorazepam|The results below represent the mean change in YMRS scores for all 19 subjects following administration of Lorazepam.
382643|NCT00431184|O1|Outcome|Pentazocine|The results below represent the mean change in YMRS scores for all 19 subjects following administration of Pentazocine.
382644|NCT00431184|O2|Outcome|Lorazepam|Subjects received 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later
382645|NCT00431184|O1|Outcome|Pentazocine|Subjects received 50mg of pentazocine
382646|NCT00431184|E2|Reported Event|Lorazepam|All subjects receive 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later on either Day 1 or Day 2.
382647|NCT00431184|E1|Reported Event|Pentazocine|All subjects receive 50mg of pentazocine followed by a second dose of 50mg two hours later on either Day 1 or Day 2.
382648|NCT00431444|B3|Baseline|Total|Total of all reporting groups
382649|NCT00431444|B2|Baseline|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382650|NCT00431444|B1|Baseline|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382651|NCT00431444|P2|Participant Flow|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382652|NCT00431444|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382653|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382654|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382655|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382656|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382657|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382658|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382659|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382660|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382661|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382662|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382663|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382664|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382665|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382666|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382667|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382668|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382669|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382670|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
382671|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
382676|NCT00437645|B2|Baseline|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382716|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
383025|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
382677|NCT00437645|B1|Baseline|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382678|NCT00437645|P2|Participant Flow|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382679|NCT00437645|P1|Participant Flow|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382680|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382681|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382682|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382683|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382684|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382685|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382686|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382687|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
397462|NCT00477269|O2|Outcome|Placebo|Placebo
382688|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382689|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382690|NCT00437645|E2|Reported Event|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382691|NCT00437645|E1|Reported Event|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
382692|NCT00438932|B5|Baseline|Total|Total of all reporting groups
382693|NCT00438932|B4|Baseline|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
382694|NCT00438932|B3|Baseline|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
382695|NCT00438932|B2|Baseline|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
382696|NCT00438932|B1|Baseline|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
382697|NCT00438932|P4|Participant Flow|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
382698|NCT00438932|P3|Participant Flow|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
382699|NCT00438932|P2|Participant Flow|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
382700|NCT00438932|P1|Participant Flow|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
382701|NCT00438932|O4|Outcome|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
382702|NCT00438932|O3|Outcome|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
382703|NCT00438932|O2|Outcome|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
382704|NCT00438932|O1|Outcome|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
382705|NCT00438932|O4|Outcome|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
382706|NCT00438932|O3|Outcome|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
382707|NCT00438932|O2|Outcome|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
382708|NCT00438932|O1|Outcome|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
382709|NCT00438932|E4|Reported Event|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
382710|NCT00438932|E3|Reported Event|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
382711|NCT00438932|E2|Reported Event|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
382712|NCT00438932|E1|Reported Event|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
382713|NCT00438971|B1|Baseline|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
382744|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
382714|NCT00438971|P1|Participant Flow|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
382715|NCT00438971|O1|Outcome|Duloxetine|
382748|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
382717|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
382718|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
382719|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
382720|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
382721|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
382722|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
382723|NCT00438971|E1|Reported Event|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
382724|NCT00439140|B4|Baseline|Total|Total of all reporting groups
382725|NCT00439140|B3|Baseline|Placebo/Botulinum Toxin Type A|Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable).
382726|NCT00439140|B2|Baseline|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
382727|NCT00439140|B1|Baseline|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
382728|NCT00439140|P3|Participant Flow|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1. (If applicable after 12 weeks, participants received either botulinum toxin Type A 200U or 300U in Treatment Cycle 2.)
382729|NCT00439140|P2|Participant Flow|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
382730|NCT00439140|P1|Participant Flow|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
382731|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
382732|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
382733|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
382734|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
382735|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
382736|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
382737|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
382738|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
382739|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
382740|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
382741|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
382742|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
382743|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
383017|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
382745|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
382746|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
382747|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
382749|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
382750|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
382751|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
382752|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
382753|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
382754|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
382755|NCT00439140|E3|Reported Event|Placebo/Botulinum Toxin Type A|Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable).
382756|NCT00439140|E2|Reported Event|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
382757|NCT00439140|E1|Reported Event|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
382758|NCT00439179|B5|Baseline|Total|Total of all reporting groups
382759|NCT00439179|B4|Baseline|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
382760|NCT00439179|B3|Baseline|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
382761|NCT00439179|B2|Baseline|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
382762|NCT00439179|B1|Baseline|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
382763|NCT00439179|P4|Participant Flow|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day.(combination)
382764|NCT00439179|P3|Participant Flow|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day. (combination)
382765|NCT00439179|P2|Participant Flow|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day. (combination)
382766|NCT00439179|P1|Participant Flow|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day. (combination)
382767|NCT00439179|O4|Outcome|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
382768|NCT00439179|O3|Outcome|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
382769|NCT00439179|O2|Outcome|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
382770|NCT00439179|O1|Outcome|Cohorts 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
382771|NCT00439179|O4|Outcome|Cohort 4|GEMOX+ GW572016 1500mg/day
382772|NCT00439179|O3|Outcome|Cohort 3|GEMOX+ GW572016 1000mg day
382773|NCT00439179|O2|Outcome|Cohort 2|weekly gem+ GW572016, 1500mg/day
382774|NCT00439179|O1|Outcome|Cohorts 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
382775|NCT00439179|E4|Reported Event|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
382776|NCT00439179|E3|Reported Event|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
382777|NCT00439179|E2|Reported Event|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
382778|NCT00439179|E1|Reported Event|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
382779|NCT00439218|B1|Baseline|Subject Enrollments (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
382780|NCT00439218|P1|Participant Flow|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
382781|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
382795|NCT00439244|B3|Baseline|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
397463|NCT00477269|O1|Outcome|STI571|STI571
382782|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
382840|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382783|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
382784|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
382785|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
382786|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
382787|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
382788|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
382789|NCT00439218|E1|Reported Event|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
382790|NCT00439231|B1|Baseline|CLL Subjects Response to Lenalidomide (Revlimid)|To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL) using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
382791|NCT00439231|P1|Participant Flow|CLL Subjects Response to Lenalidomide (Revlimid)|To establish a response rate to lenalidomide (Revlimid) in subjects with CLL/SLL using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
382792|NCT00439231|O1|Outcome|CLL Subject Response Rate After Lenalidomide Therapy|To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) using a 3 week on, 3 week off dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
382793|NCT00439231|E1|Reported Event|CLL Subjects Treated With Lenalidomide (Revlimid)|
382794|NCT00439244|B4|Baseline|Total|Total of all reporting groups
382796|NCT00439244|B2|Baseline|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
383018|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
382797|NCT00439244|B1|Baseline|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382917|NCT00439413|B3|Baseline|Total|Total of all reporting groups
383026|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
382798|NCT00439244|P3|Participant Flow|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382799|NCT00439244|P2|Participant Flow|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
382800|NCT00439244|P1|Participant Flow|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382801|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382802|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
382803|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382804|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382805|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
382806|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382807|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382808|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
382809|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382810|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382811|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
382812|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382813|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382814|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
382914|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382815|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382816|NCT00439244|E3|Reported Event|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382817|NCT00439244|E2|Reported Event|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
382818|NCT00439244|E1|Reported Event|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
382819|NCT00439270|B6|Baseline|Total|Total of all reporting groups
382820|NCT00439270|B5|Baseline|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382821|NCT00439270|B4|Baseline|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382822|NCT00439270|B3|Baseline|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382823|NCT00439270|B2|Baseline|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382824|NCT00439270|B1|Baseline|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382825|NCT00439270|P5|Participant Flow|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382826|NCT00439270|P4|Participant Flow|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382827|NCT00439270|P3|Participant Flow|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382828|NCT00439270|P2|Participant Flow|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382829|NCT00439270|P1|Participant Flow|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.
382830|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382831|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382832|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382833|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382834|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382835|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382836|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382837|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382838|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382864|NCT00439270|E3|Reported Event|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.
382839|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
383027|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
382841|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382842|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382843|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382844|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382845|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382846|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382847|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382848|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382849|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
382850|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382851|NCT00439270|O1|Outcome|All Treated|Participants received dasatinib, 50, 70, 100, or 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 or 75 mg/m^2.
382852|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 (Phase 2 )|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382853|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382854|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382855|NCT00439270|O1|Outcome|All Treated (Phase 1)|Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If, for a dose level combination, 2 or more DLTs were observed, the maximum tolerated dose was defined as the previous dose level combination.
382856|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382857|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382858|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382859|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382860|NCT00439270|O1|Outcome|All Treated (Phase 1)|Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If 2 or more DLTs were observed for a dose level combination, the MTD was defined as the previous dose level combination.
382861|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382862|NCT00439270|E5|Reported Event|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382863|NCT00439270|E4|Reported Event|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
384843|NCT00445432|O3|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
382865|NCT00439270|E2|Reported Event|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382866|NCT00439270|E1|Reported Event|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
382867|NCT00439309|B3|Baseline|Total|Total of all reporting groups
442798|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
382868|NCT00439309|B2|Baseline|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
382869|NCT00439309|B1|Baseline|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
382870|NCT00439309|P2|Participant Flow|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
382871|NCT00439309|P1|Participant Flow|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
382872|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
382873|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
382874|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
382875|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
382876|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
382877|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
382878|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
382879|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
382880|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
382913|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382881|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
383028|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
382882|NCT00439309|E2|Reported Event|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
382883|NCT00439309|E1|Reported Event|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
382884|NCT00439335|B3|Baseline|Total|Total of all reporting groups
382885|NCT00439335|B2|Baseline|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382886|NCT00439335|B1|Baseline|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382887|NCT00439335|P2|Participant Flow|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382888|NCT00439335|P1|Participant Flow|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382889|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382890|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382891|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382892|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382893|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382894|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382895|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382896|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382897|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382898|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382899|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382900|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382901|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382902|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382903|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382904|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382905|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382906|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382907|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382908|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382909|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382910|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382911|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382912|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382915|NCT00439335|E2|Reported Event|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
382916|NCT00439335|E1|Reported Event|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
382918|NCT00439413|B2|Baseline|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
382919|NCT00439413|B1|Baseline|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
382920|NCT00439413|P2|Participant Flow|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
382921|NCT00439413|P1|Participant Flow|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
382922|NCT00439413|O2|Outcome|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
382923|NCT00439413|O1|Outcome|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
382924|NCT00439413|O2|Outcome|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.
During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks.
Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
382925|NCT00439413|O1|Outcome|Selegiline Transdermal System|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.
During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks.
Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
382926|NCT00439413|E2|Reported Event|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.
During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks.
Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
382927|NCT00439413|E1|Reported Event|Selegiline Transdermal System|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.
During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks.
Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
382928|NCT00439517|B3|Baseline|Total|Total of all reporting groups
382929|NCT00439517|B2|Baseline|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382930|NCT00439517|B1|Baseline|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382931|NCT00439517|P2|Participant Flow|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382932|NCT00439517|P1|Participant Flow|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382933|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382934|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382935|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382936|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382937|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382938|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382939|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382940|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382941|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382942|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382943|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382944|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382945|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382946|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382947|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382948|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382949|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382950|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382951|NCT00439517|E2|Reported Event|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
382952|NCT00439517|E1|Reported Event|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
382966|NCT00439608|O1|Outcome|Treatment|Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
384844|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
382969|NCT00439647|B2|Baseline|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
384934|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
382953|NCT00439569|B1|Baseline|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
382954|NCT00439569|P1|Participant Flow|Subjects Enrolled|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1. Two new subjects were then enrolled in Cohort 2.
382955|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
382956|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
382957|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
382958|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
382959|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
382960|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
382961|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
382962|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
382963|NCT00439569|E1|Reported Event|Cohorts 1 & 2 (500 mg/kg/Day)|Cohort 1 was assigned a dosage of 500 mg/kg/day. One subject was replaced due to an allergic reaction and four subjects due to less than 80 percent study drug compliance. Due to these replacements, more than 3 subjects were enrolled in the first cohort. Cohort 2 was assigned a dosage of 500 mg/kg/day by the MCRM and approved by the SMC due to dose-limiting toxicities experienced in Cohort 1. For the purpose of reporting adverse events, these two cohorts were combined for a total of 9 enrolled subjects.
382964|NCT00439608|B1|Baseline|Treatment|
382965|NCT00439608|P1|Participant Flow|Treatment|"Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
Patients received cetuximab, 400 mg/mg2 over 2 h on Day 1 then 250 mg/m2/week over 1 h, for 5 additional weeks. Patients also received paclitaxel, 50 mg/m2/week, over 1 h and carboplatin AUC (area under the curve) = 2/week, over 30 min, for 6 weeks. Cetuximab was administered first. Patients were then monitored for 1 h. Paclitaxel was then administered followed by carboplatin. Radiation was generally administered after chemotherapy. Dexamethasone 20 mg intravenously (IV), diphenhydramine 50 mg IV, and ranitidine 50 mg IV were given 30 min before treatment. Dosages of dexamethasone and diphenhydramine could be reduced in subsequent weeks if no hypersensitivity reactions were observed."
382970|NCT00439647|B1|Baseline|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382971|NCT00439647|P2|Participant Flow|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382972|NCT00439647|P1|Participant Flow|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382973|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382974|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382975|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382976|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382977|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382978|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382979|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382980|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382981|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382982|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382983|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382984|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382985|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382986|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382987|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382988|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382989|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382990|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382991|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382992|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382993|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382994|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382995|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382996|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382997|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382998|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
382999|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
383000|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
383001|NCT00439647|E2|Reported Event|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year
383002|NCT00439647|E1|Reported Event|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year
383003|NCT00439725|B3|Baseline|Total|Total of all reporting groups
383004|NCT00439725|B2|Baseline|Placebo|Participants were to receive matching placebo oral tablet once daily
383005|NCT00439725|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383006|NCT00439725|P2|Participant Flow|Placebo|Participants were to receive matching placebo oral tablet once daily
383007|NCT00439725|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383008|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383009|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383010|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383011|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383012|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383013|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383014|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383023|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383024|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
384935|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
383029|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383030|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383031|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383032|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383033|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383034|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383035|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383036|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383037|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383038|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383039|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383040|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383041|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383042|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383043|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383044|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383045|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383046|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
383047|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383048|NCT00439725|E2|Reported Event|Placebo|Participants were to receive matching placebo oral tablet once daily
383049|NCT00439725|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
383050|NCT00439738|B3|Baseline|Total|Total of all reporting groups
383051|NCT00439738|B2|Baseline|HCTZ +Amlodipine|
383052|NCT00439738|B1|Baseline|Valsartan/HCTZ (Hydrochlorothiazide)|
383053|NCT00439738|P2|Participant Flow|HCTZ +Amlodipine|
383054|NCT00439738|P1|Participant Flow|Valsartan/HCTZ (Hydrochlorothiazide)|
383055|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
383056|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
383057|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
383058|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
383059|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
383060|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
383061|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
383062|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
383063|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
383064|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
383065|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
383066|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
383067|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
383068|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
383069|NCT00439777|B3|Baseline|Total|Total of all reporting groups
383070|NCT00439777|B2|Baseline|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383071|NCT00439777|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383072|NCT00439777|P2|Participant Flow|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383073|NCT00439777|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383074|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383075|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383076|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383077|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383149|NCT00440050|E2|Reported Event|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
383078|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383079|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383080|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
384936|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
383081|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383082|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383083|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383084|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383085|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383086|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383087|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383088|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383089|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383090|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383091|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383092|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383093|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383094|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383095|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383096|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383097|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383098|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383099|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383100|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383101|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383102|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383103|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383104|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383105|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383106|NCT00439777|E2|Reported Event|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
383107|NCT00439777|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
383108|NCT00439946|B1|Baseline|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383109|NCT00439946|P1|Participant Flow|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil initiated to deliver a dose 20% higher than the epoprostenol dose on a ng/kg/min basis. IV treprostinil dosing was titrated without restriction during the eight week follow-up period per the investigator's judgment to optimize the dose for symptomatic benefit based on clinical signs / symptoms, exercise capacity and tolerability.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383153|NCT00440115|B2|Baseline|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
383110|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383111|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383112|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383113|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383114|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383115|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383116|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383117|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383118|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383119|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383120|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383121|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383122|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383123|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383124|NCT00439946|E1|Reported Event|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
383125|NCT00440011|B3|Baseline|Total|Total of all reporting groups
383126|NCT00440011|B2|Baseline|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
383127|NCT00440011|B1|Baseline|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
383128|NCT00440011|P2|Participant Flow|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
383129|NCT00440011|P1|Participant Flow|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
383130|NCT00440011|O2|Outcome|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
383131|NCT00440011|O1|Outcome|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
383132|NCT00440011|O2|Outcome|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
383133|NCT00440011|O1|Outcome|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
383134|NCT00440011|E2|Reported Event|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
383135|NCT00440011|E1|Reported Event|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
383136|NCT00440050|B3|Baseline|Total|Total of all reporting groups
383137|NCT00440050|B2|Baseline|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
383138|NCT00440050|B1|Baseline|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
383139|NCT00440050|P2|Participant Flow|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
383140|NCT00440050|P1|Participant Flow|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
383141|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
383142|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
383143|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
383144|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
383145|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
383146|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
383147|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
383148|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
383150|NCT00440050|E1|Reported Event|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
383151|NCT00440115|B4|Baseline|Total|Total of all reporting groups
383152|NCT00440115|B3|Baseline|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
383322|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383154|NCT00440115|B1|Baseline|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
383155|NCT00440115|P3|Participant Flow|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
383156|NCT00440115|P2|Participant Flow|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
383157|NCT00440115|P1|Participant Flow|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
383158|NCT00440115|O3|Outcome|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
383159|NCT00440115|O2|Outcome|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
383160|NCT00440115|O1|Outcome|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
383161|NCT00440115|O3|Outcome|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
383162|NCT00440115|O2|Outcome|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
383163|NCT00440115|O1|Outcome|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
383164|NCT00440115|O3|Outcome|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
383165|NCT00440115|O2|Outcome|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
383166|NCT00440115|O1|Outcome|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
383167|NCT00440115|E3|Reported Event|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
383168|NCT00440115|E2|Reported Event|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
383169|NCT00440115|E1|Reported Event|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
383170|NCT00440180|B3|Baseline|Total|Total of all reporting groups
383171|NCT00440180|B2|Baseline|Anastrozole|1 milligram daily
383172|NCT00440180|B1|Baseline|Placebo|Placebo once daily
383173|NCT00440180|P2|Participant Flow|Anastrozole|1 milligram daily
383174|NCT00440180|P1|Participant Flow|Placebo|Placebo once daily
383175|NCT00440180|O2|Outcome|Anastrozole|1 milligram daily
383176|NCT00440180|O1|Outcome|Placebo|Placebo once daily
383177|NCT00440180|E2|Reported Event|Anastrozole|1 milligram daily
383178|NCT00440180|E1|Reported Event|Placebo|Placebo once daily
383179|NCT00440193|B3|Baseline|Total|Total of all reporting groups
383180|NCT00440193|B2|Baseline|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383181|NCT00440193|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383182|NCT00440193|P2|Participant Flow|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383183|NCT00440193|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383184|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383185|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383186|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383187|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383188|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383189|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383190|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383191|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383192|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383193|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
384937|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
383194|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383195|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383196|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383197|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383198|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383199|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383200|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383201|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383202|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383203|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383204|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383205|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383206|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383207|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383208|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383209|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383210|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383211|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383212|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383213|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383214|NCT00440193|E2|Reported Event|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
383215|NCT00440193|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
383216|NCT00440232|B3|Baseline|Total|Total of all reporting groups
383217|NCT00440232|B2|Baseline|Placebo|
383218|NCT00440232|B1|Baseline|Frovatriptan|5.0 mg of Frovatriptan given as single dose
383219|NCT00440232|P2|Participant Flow|Placebo|
383220|NCT00440232|P1|Participant Flow|Frovatriptan|5.0 mg of Frovatriptan given as single dose
383221|NCT00440232|O2|Outcome|Placebo|
383222|NCT00440232|O1|Outcome|Frovatriptan|5.0 mg of Frovatriptan given as single dose
383223|NCT00440232|O2|Outcome|Placebo|
383224|NCT00440232|O1|Outcome|Frovatriptan|5.0 mg of Frovatriptan given as single dose
383225|NCT00440232|E2|Reported Event|Placebo|
383226|NCT00440232|E1|Reported Event|Frovatriptan|5.0 mg of Frovatriptan given as single dose
383227|NCT00440271|B3|Baseline|Total|Total of all reporting groups
383228|NCT00440271|B2|Baseline|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383229|NCT00440271|B1|Baseline|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383323|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383324|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
383230|NCT00440271|P2|Participant Flow|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383231|NCT00440271|P1|Participant Flow|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383232|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383233|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383234|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383235|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383236|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383237|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383238|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383239|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383240|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383241|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383242|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383243|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383244|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383245|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383246|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383247|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383248|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383249|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383250|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383251|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383252|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383253|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383254|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383255|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383256|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383257|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383258|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383259|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383260|NCT00440271|E2|Reported Event|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
383261|NCT00440271|E1|Reported Event|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
383262|NCT00440297|B3|Baseline|Total|Total of all reporting groups
383263|NCT00440297|B2|Baseline|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
383264|NCT00440297|B1|Baseline|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
383265|NCT00440297|P2|Participant Flow|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
383266|NCT00440297|P1|Participant Flow|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
383267|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
383268|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
383269|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
383270|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
383271|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
383272|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
383273|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
383274|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
383275|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
383276|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
383277|NCT00440297|E2|Reported Event|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
383278|NCT00440297|E1|Reported Event|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
383279|NCT00440310|B3|Baseline|Total|Total of all reporting groups
383280|NCT00440310|B2|Baseline|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
383320|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383321|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
397464|NCT00477269|E3|Reported Event|Extension - STI571|Extension - STI571
383325|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383326|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383281|NCT00440310|B1|Baseline|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
383282|NCT00440310|P2|Participant Flow|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
383283|NCT00440310|P1|Participant Flow|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
383284|NCT00440310|O2|Outcome|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
383285|NCT00440310|O1|Outcome|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
383286|NCT00440310|E2|Reported Event|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
383287|NCT00440310|E1|Reported Event|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
383288|NCT00440401|B3|Baseline|Total|Total of all reporting groups
383289|NCT00440401|B2|Baseline|Standard Treatment|
383290|NCT00440401|B1|Baseline|TachoSil®|
383291|NCT00440401|P2|Participant Flow|Comparator|Standard haemostatic treatment in cardiovascular surgery
383292|NCT00440401|P1|Participant Flow|TachoSil®|Absorbable sponge for intra-operative topical application
383293|NCT00440401|O2|Outcome|Standard Treatment|
383294|NCT00440401|O1|Outcome|TachoSil®|
383295|NCT00440401|O2|Outcome|Standard Treatment|
383296|NCT00440401|O1|Outcome|TachoSil®|
383297|NCT00440401|E2|Reported Event|Standard Treatment|
383298|NCT00440401|E1|Reported Event|TachoSil®|
383299|NCT00440466|B4|Baseline|Total|Total of all reporting groups
383300|NCT00440466|B3|Baseline|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
383301|NCT00440466|B2|Baseline|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383302|NCT00440466|B1|Baseline|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383303|NCT00440466|P3|Participant Flow|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
383304|NCT00440466|P2|Participant Flow|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383305|NCT00440466|P1|Participant Flow|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383306|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
383307|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383308|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383309|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
383310|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383311|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383312|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
383313|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383314|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383315|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
383316|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383317|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383318|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
383319|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383327|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
383328|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383329|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383330|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
383331|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383332|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383333|NCT00440466|E3|Reported Event|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
383334|NCT00440466|E2|Reported Event|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
383335|NCT00440466|E1|Reported Event|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
383336|NCT00440505|B1|Baseline|Entire Study Population|
383337|NCT00440505|P6|Participant Flow|Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg|Nicotine 10 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
383338|NCT00440505|P5|Participant Flow|Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo|Nicotine 10 mg patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
383339|NCT00440505|P4|Participant Flow|Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg|Nicotine 5 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
383340|NCT00440505|P3|Participant Flow|Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo|Nicotine 5 mg patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
383341|NCT00440505|P2|Participant Flow|Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg|Placebo patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
383342|NCT00440505|P1|Participant Flow|Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg|Placebo patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
383343|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
383344|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
383345|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
383346|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
383347|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
383348|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
383349|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
383350|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
383351|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
383352|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
383353|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
383354|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
383355|NCT00440505|E3|Reported Event|Nicotine 10mg|Non-smokers with the Nicotine 10mg patch
383356|NCT00440505|E2|Reported Event|Nicotine 5mg|Non-smokers with the Nicotine 5mg patch
383357|NCT00440505|E1|Reported Event|Placebo|Non-smokers with the placebo patch
383358|NCT00440518|B4|Baseline|Total|Total of all reporting groups
383359|NCT00440518|B3|Baseline|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383360|NCT00440518|B2|Baseline|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383361|NCT00440518|B1|Baseline|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
383362|NCT00440518|P3|Participant Flow|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383363|NCT00440518|P2|Participant Flow|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
384845|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
383364|NCT00440518|P1|Participant Flow|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
383365|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383366|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383367|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
383368|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383369|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383370|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
383371|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383372|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383373|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
383374|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383375|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383376|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
383377|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383378|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383379|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
383380|NCT00440518|E3|Reported Event|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383381|NCT00440518|E2|Reported Event|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
383382|NCT00440518|E1|Reported Event|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
383383|NCT00440531|B4|Baseline|Total|Total of all reporting groups
383384|NCT00440531|B3|Baseline|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
383385|NCT00440531|B2|Baseline|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
383386|NCT00440531|B1|Baseline|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
383387|NCT00440531|P3|Participant Flow|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
383388|NCT00440531|P2|Participant Flow|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
383389|NCT00440531|P1|Participant Flow|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
383390|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
383391|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
383392|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
383393|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
383394|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
383395|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
383396|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
383397|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
383398|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
383399|NCT00440531|O1|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
383400|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
383401|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
383402|NCT00440557|B4|Baseline|Total|Total of all reporting groups
383403|NCT00440557|B3|Baseline|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
383404|NCT00440557|B2|Baseline|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
383405|NCT00440557|B1|Baseline|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
383406|NCT00440557|P3|Participant Flow|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
383407|NCT00440557|P2|Participant Flow|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
383408|NCT00440557|P1|Participant Flow|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
383409|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
383410|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
383411|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
383412|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
383413|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
383566|NCT00441064|E1|Reported Event|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet.
383414|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
383415|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
383416|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
442799|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
383417|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
383418|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
383419|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
383420|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
383421|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
383422|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
383423|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
383424|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
383425|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
383426|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
383427|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
383428|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
383429|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
383430|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
383431|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
383432|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
383433|NCT00440557|E3|Reported Event|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
383434|NCT00440557|E2|Reported Event|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
383435|NCT00440557|E1|Reported Event|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
383436|NCT00440700|B4|Baseline|Total|Total of all reporting groups
383437|NCT00440700|B3|Baseline|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
383438|NCT00440700|B2|Baseline|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
383439|NCT00440700|B1|Baseline|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
383440|NCT00440700|P3|Participant Flow|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
383441|NCT00440700|P2|Participant Flow|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
383442|NCT00440700|P1|Participant Flow|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
383443|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
383444|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
383445|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
383446|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
383447|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
383448|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
383449|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
383450|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
383451|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
383452|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
383453|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
383490|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
383454|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
383455|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
383456|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
383457|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
383458|NCT00440700|E3|Reported Event|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
383459|NCT00440700|E2|Reported Event|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
383460|NCT00440700|E1|Reported Event|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
383461|NCT00440830|B5|Baseline|Total|Total of all reporting groups
383462|NCT00440830|B4|Baseline|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
383463|NCT00440830|B3|Baseline|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
383464|NCT00440830|B2|Baseline|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
383465|NCT00440830|B1|Baseline|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
383466|NCT00440830|P4|Participant Flow|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
383467|NCT00440830|P3|Participant Flow|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
383468|NCT00440830|P2|Participant Flow|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
383469|NCT00440830|P1|Participant Flow|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
383470|NCT00440830|O4|Outcome|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
383471|NCT00440830|O3|Outcome|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
383472|NCT00440830|O2|Outcome|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
383473|NCT00440830|O1|Outcome|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
383474|NCT00440830|O4|Outcome|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
383475|NCT00440830|O3|Outcome|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
383476|NCT00440830|O2|Outcome|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
383477|NCT00440830|O1|Outcome|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
383478|NCT00440830|E4|Reported Event|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
383479|NCT00440830|E3|Reported Event|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
383480|NCT00440830|E2|Reported Event|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
383481|NCT00440830|E1|Reported Event|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
383482|NCT00440947|B1|Baseline|ABC/3TC + ATV/r|All participants starting the Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
383483|NCT00440947|P5|Participant Flow|ABC/3TC + ATV/r: Extension Phase|Continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
383484|NCT00440947|P4|Participant Flow|ABC/3TC + ATV: Extension Phase|Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
383485|NCT00440947|P3|Participant Flow|ABC/3TC + ATV/r: Randomization Phase|Continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
383486|NCT00440947|P2|Participant Flow|ABC/3TC + ATV: Randomization Phase|Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with 400 mg ATV QD
383487|NCT00440947|P1|Participant Flow|ABC/3TC + ATV/r: Induction Phase|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
383488|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
383567|NCT00441103|B3|Baseline|Total|Total of all reporting groups
383489|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
384938|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
383491|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
383492|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
383493|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
383494|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
383495|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
383496|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
383497|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
383498|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
383499|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
383500|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
383501|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
383502|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
383503|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
383504|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
383505|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
383506|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
383507|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
383508|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
383509|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
383510|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
383511|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
383512|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
383513|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
383514|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
383515|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
383516|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
383517|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
383518|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
383519|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
383520|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
383521|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
383522|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
383523|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
383524|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
383525|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
383526|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
383527|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
383528|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
383529|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
383530|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
383531|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
383532|NCT00440947|E5|Reported Event|ABC/3TC + ATV/r: Extension Phase|participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
383533|NCT00440947|E4|Reported Event|ABC/3TC + ATV: Extension Phase|Extension Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
383534|NCT00440947|E3|Reported Event|ABC/3TC + ATV/r: Randomization Phase|Randomization Phase: participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD; includes SAEs that occurred during induction phase
383535|NCT00440947|E2|Reported Event|ABC/3TC + ATV: Randomization Phase|Randomization Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD; includes serious adverse events (SAEs) that occurred during induction phase
383536|NCT00440947|E1|Reported Event|ABC/3TC + ATV/r: Induction Phase|Induction Phase: participants in the Safety Population (participants exposed to at least one dose of investigational product) receiving abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
383537|NCT00441012|B3|Baseline|Total|Total of all reporting groups
383538|NCT00441012|B2|Baseline|COMVAX™|"COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
3 participants in the COMVAX™ group vaccinated but not randomized; overall N is 276, not 273 - due to issues randomizing via IVRS, in violation, all 3 participants were vaccinated as randomly assigned by the Investigator."
383539|NCT00441012|B1|Baseline|Modified Process Vaccine|"Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
1 participant randomized but not vaccinated in the Modified Process Vaccine group; overall N is 269, not 270."
383540|NCT00441012|P2|Participant Flow|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
383541|NCT00441012|P1|Participant Flow|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
383542|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
383543|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
383544|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
383545|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
383546|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
383547|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
383548|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
383549|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
383550|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
383551|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
383552|NCT00441012|E2|Reported Event|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
383553|NCT00441012|E1|Reported Event|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
383554|NCT00441064|B3|Baseline|Total|Total of all reporting groups
383555|NCT00441064|B2|Baseline|Diet Sequence High/Low Sodium|Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and on low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]
383556|NCT00441064|B1|Baseline|Diet Sequence Low/High Sodium|Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks and high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
383557|NCT00441064|P2|Participant Flow|Diet Sequence High/Low Sodium|Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and crossed over to the low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]
383558|NCT00441064|P1|Participant Flow|Diet Sequence Low/High Sodium|Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks who crossed over to the high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
383559|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
383560|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
383561|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
383562|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
383563|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
383564|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
383565|NCT00441064|E2|Reported Event|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet.
383568|NCT00441103|B2|Baseline|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
383569|NCT00441103|B1|Baseline|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
442800|NCT00594425|O3|Outcome|Vehicle PDT|
383570|NCT00441103|P2|Participant Flow|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
383571|NCT00441103|P1|Participant Flow|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 microgram (mcg) administered subcutaneously three times a week for 40 weeks.
383572|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
383573|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
383574|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
383575|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
383576|NCT00441103|O1|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
383577|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
383578|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
383579|NCT00441103|E2|Reported Event|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
383580|NCT00441103|E1|Reported Event|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
383581|NCT00441116|B3|Baseline|Total|Total of all reporting groups
383582|NCT00441116|B2|Baseline|Placebo|Subjects who were given no Investigational product.
383583|NCT00441116|B1|Baseline|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383584|NCT00441116|P2|Participant Flow|Placebo|Subjects who were given no Investigational product.
383585|NCT00441116|P1|Participant Flow|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383586|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383587|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383588|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383589|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383590|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383591|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383592|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383593|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383594|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383595|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383596|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383597|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383598|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383599|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383600|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383601|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383602|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383603|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383604|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383605|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383606|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383607|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383608|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383609|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383610|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383611|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383612|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383613|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383614|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383615|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383616|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383617|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383618|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383619|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383620|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383621|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383622|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383623|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383624|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383625|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383626|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383627|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383628|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383629|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383630|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383631|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383632|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383633|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383634|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383635|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383636|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383637|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383638|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383639|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383640|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383641|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383642|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383643|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383644|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
397465|NCT00477269|E2|Reported Event|Core - Placebo|Core - Placebo
383645|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383646|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
383647|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383648|NCT00441116|E2|Reported Event|Placebo|Subjects who were given no Investigational product.
383649|NCT00441116|E1|Reported Event|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
383650|NCT00441142|B5|Baseline|Total|Total of all reporting groups
383651|NCT00441142|B4|Baseline|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383652|NCT00441142|B3|Baseline|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
383653|NCT00441142|B2|Baseline|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383654|NCT00441142|B1|Baseline|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383655|NCT00441142|P4|Participant Flow|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383656|NCT00441142|P3|Participant Flow|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
383657|NCT00441142|P2|Participant Flow|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383679|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
384141|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
383658|NCT00441142|P1|Participant Flow|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383659|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383660|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
383661|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383662|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383663|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383664|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
383665|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383678|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
383666|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383667|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383668|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
383669|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383670|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383671|NCT00441142|E2|Reported Event|Phase II-Arm A Pts (Control Group): RT + TMZ|"The Induction Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
383672|NCT00441142|E1|Reported Event|Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib|"The Induction Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the Maintenance Phase:
12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
383673|NCT00441168|B3|Baseline|Total|Total of all reporting groups
383674|NCT00441168|B2|Baseline|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
383675|NCT00441168|B1|Baseline|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
383676|NCT00441168|P2|Participant Flow|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
383677|NCT00441168|P1|Participant Flow|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
383739|NCT00441285|O1|Outcome|Carbamazepine|Area Under the Curve of Praziquantel in Patients Receiving Carbamazepine
383680|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
383681|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
383682|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
383683|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
383684|NCT00441168|E2|Reported Event|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
383685|NCT00441168|E1|Reported Event|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
383686|NCT00441259|B3|Baseline|Total|Total of all reporting groups
383687|NCT00441259|B2|Baseline|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
383688|NCT00441259|B1|Baseline|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
383689|NCT00441259|P2|Participant Flow|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
383690|NCT00441259|P1|Participant Flow|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
383691|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
383692|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
383693|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
383694|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
383695|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
383696|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
383697|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
383698|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
383699|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
383700|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
383701|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
383702|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
383703|NCT00441259|E2|Reported Event|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
383704|NCT00441259|E1|Reported Event|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
383705|NCT00441272|B3|Baseline|Total|Total of all reporting groups
383706|NCT00441272|B2|Baseline|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
383707|NCT00441272|B1|Baseline|Placebo|Those participants receiving placebo for 48 weeks
383708|NCT00441272|P2|Participant Flow|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
383709|NCT00441272|P1|Participant Flow|Placebo|Those participants receiving placebo for 48 weeks
383710|NCT00441272|O2|Outcome|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
383711|NCT00441272|O1|Outcome|Placebo|Those participants receiving placebo for 48 weeks
383712|NCT00441272|E2|Reported Event|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
383713|NCT00441272|E1|Reported Event|Placebo|Those participants receiving placebo for 48 weeks
383714|NCT00441285|B6|Baseline|Total|Total of all reporting groups
383715|NCT00441285|B5|Baseline|Phase III Trial Standard ABZ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
A placebo of ABZ was added to complete the doses to the dosage in the Increased ABZ arm
Praziquantel placebo was given in two daily doses, morning and evening,for 10 days."
383886|NCT00434590|O2|Outcome|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
384006|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
383716|NCT00441285|B4|Baseline|Phase III Trial Increased ABZ|"Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d , for 10 days.
Praziquantel placebo was given in two daily doses, morning and evening,for 10 days."
383717|NCT00441285|B3|Baseline|Phase III Trial ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
A placebo of ABZ was added to complete to the doses in the Increased ABZ arm
Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 10 days."
383718|NCT00441285|B2|Baseline|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
383719|NCT00441285|B1|Baseline|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
383720|NCT00441285|P5|Participant Flow|Phase III Trial - Standard ABZ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)
Placebo of Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
383721|NCT00441285|P4|Participant Flow|Phase III Trial - Increased ABZ|"Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d, for 10 days.
Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
383722|NCT00441285|P3|Participant Flow|Phase III Trial - ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)
Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
383723|NCT00441285|P2|Participant Flow|PK Substudy ABZ+Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
383724|NCT00441285|P1|Participant Flow|PK Substudy ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
383725|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
383726|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
383727|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
383728|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
383729|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
383730|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
383731|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
383732|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
383733|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
383734|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
383735|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
383736|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
383737|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
383738|NCT00441285|O2|Outcome|Phenytoin|Area Under the Curve of Praziquantel in Patients Receiving Phenytoin
383972|NCT00434967|B5|Baseline|Total|Total of all reporting groups
383740|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg/kg/day, divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg/day, for 10 days.
Praziquantel was given at 50 mg/kg/day, divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g/day,for 9 1/2 days."
383741|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
383742|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
383743|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
383744|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
383745|NCT00441285|E2|Reported Event|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
383746|NCT00441285|E1|Reported Event|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.
Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
383747|NCT00441337|B5|Baseline|Total|Total of all reporting groups
383748|NCT00441337|B4|Baseline|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383749|NCT00441337|B3|Baseline|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383750|NCT00441337|B2|Baseline|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383751|NCT00441337|B1|Baseline|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383752|NCT00441337|P4|Participant Flow|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383753|NCT00441337|P3|Participant Flow|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383766|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383754|NCT00441337|P2|Participant Flow|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383755|NCT00441337|P1|Participant Flow|0.3 mg/kg Nivolumab|0.3 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg) was administered in a single intravenous (IV) infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383756|NCT00441337|O3|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383757|NCT00441337|O2|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383758|NCT00441337|O1|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383759|NCT00441337|O3|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383760|NCT00441337|O2|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383761|NCT00441337|O1|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383762|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383763|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383764|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383765|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383854|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
383767|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383768|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383769|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383770|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383771|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383772|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383773|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383774|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383775|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383776|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383777|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383778|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383855|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
383973|NCT00434967|B4|Baseline|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383779|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383780|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383781|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383782|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383783|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383784|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383785|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383786|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383787|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383788|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383789|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383790|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383856|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
384005|NCT00441441|O1|Outcome|No Spacer|Participants who did not use spacer and were in either treatment group
383791|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383792|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383793|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383794|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383795|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383796|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383797|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383798|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383799|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383800|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383801|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383802|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383857|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
383974|NCT00434967|B3|Baseline|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
383803|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383804|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383805|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383806|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383807|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383808|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383809|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383810|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383811|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383812|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383813|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383814|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383858|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
384038|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
383815|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383816|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383817|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383818|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383819|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383820|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383821|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383822|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383823|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
383824|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383825|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383826|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383859|NCT00434356|E2|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
384089|NCT00441480|O2|Outcome|Control|Corn oil
383827|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383828|NCT00441337|E4|Reported Event|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383829|NCT00441337|E3|Reported Event|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383830|NCT00441337|E2|Reported Event|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383831|NCT00441337|E1|Reported Event|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
383832|NCT00441363|B3|Baseline|Total|Total of all reporting groups
383833|NCT00441363|B2|Baseline|Placebo|matching placebo
383834|NCT00441363|B1|Baseline|Cycloset|0.8 mg tablet
383835|NCT00441363|P2|Participant Flow|Placebo|matching placebo
383836|NCT00441363|P1|Participant Flow|Cycloset|0.8 mg tablet
383837|NCT00441363|O2|Outcome|Placebo|matching placebo
383838|NCT00441363|O1|Outcome|Cycloset|0.8 mg tablet
383839|NCT00441363|O2|Outcome|Placebo|matching placebo
383840|NCT00441363|O1|Outcome|Cycloset|0.8 mg tablet
383841|NCT00441363|E2|Reported Event|Placebo|matching placebo
383842|NCT00441363|E1|Reported Event|Cycloset|0.8 mg tablet
383843|NCT00434356|B3|Baseline|Total|Total of all reporting groups
383844|NCT00434356|B2|Baseline|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
383845|NCT00434356|B1|Baseline|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
383846|NCT00434356|P2|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
383847|NCT00434356|P1|Participant Flow|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
383848|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
383849|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
383850|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
383851|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
383852|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
383853|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
397466|NCT00477269|E1|Reported Event|Core - STI571|Core - STI571
383860|NCT00434356|E1|Reported Event|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
383861|NCT00434421|B1|Baseline|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
383862|NCT00434421|P1|Participant Flow|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
383863|NCT00434421|O1|Outcome|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
383864|NCT00434421|E1|Reported Event|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
383865|NCT00434434|B4|Baseline|Total|Total of all reporting groups
383866|NCT00434434|B3|Baseline|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383867|NCT00434434|B2|Baseline|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383868|NCT00434434|B1|Baseline|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383869|NCT00434434|P3|Participant Flow|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383870|NCT00434434|P2|Participant Flow|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383871|NCT00434434|P1|Participant Flow|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383872|NCT00434434|O3|Outcome|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383873|NCT00434434|O2|Outcome|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383874|NCT00434434|O1|Outcome|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383875|NCT00434434|O3|Outcome|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383876|NCT00434434|O2|Outcome|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383877|NCT00434434|O1|Outcome|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383878|NCT00434434|E3|Reported Event|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383879|NCT00434434|E2|Reported Event|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383880|NCT00434434|E1|Reported Event|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
383881|NCT00434590|B3|Baseline|Total|Total of all reporting groups
383882|NCT00434590|B2|Baseline|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
383883|NCT00434590|B1|Baseline|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
383884|NCT00434590|P2|Participant Flow|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
383885|NCT00434590|P1|Participant Flow|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
383887|NCT00434590|O1|Outcome|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
383888|NCT00434590|E2|Reported Event|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
383889|NCT00434590|E1|Reported Event|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
383890|NCT00434642|B3|Baseline|Total|Total of all reporting groups
383891|NCT00434642|B2|Baseline|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
383892|NCT00434642|B1|Baseline|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
383893|NCT00434642|P2|Participant Flow|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
383894|NCT00434642|P1|Participant Flow|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
383895|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
383896|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
383897|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
383898|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
383899|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
383900|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
383901|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
384090|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384091|NCT00441480|O2|Outcome|Control|Corn oil
383902|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
383903|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
383904|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
383905|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
383906|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
383907|NCT00434642|E2|Reported Event|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
383908|NCT00434642|E1|Reported Event|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
383909|NCT00434759|B3|Baseline|Total|Total of all reporting groups
383910|NCT00434759|B2|Baseline|Standardtherapy|standard therapy (therapist-guided intervention only)
383911|NCT00434759|B1|Baseline|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
383912|NCT00434759|P2|Participant Flow|Standardtherapy|standard therapy (therapist-guided intervention only)
383913|NCT00434759|P1|Participant Flow|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
383914|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
383915|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
383916|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
383917|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
383918|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
383919|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
383920|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
383921|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
383922|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only; 16 sessions)
383923|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to 24 sessions)
383924|NCT00434759|E2|Reported Event|Standardtherapy|standard therapy (therapist-guided intervention only)
383925|NCT00434759|E1|Reported Event|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
383926|NCT00434876|B3|Baseline|Total|Total of all reporting groups
383927|NCT00434876|B2|Baseline|Placebo|Placebo
383928|NCT00434876|B1|Baseline|Quetiapine|Quetiapine XR
383975|NCT00434967|B2|Baseline|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383929|NCT00434876|P2|Participant Flow|Placebo|The matching placebo pills were similarly taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
383930|NCT00434876|P1|Participant Flow|Quetiapine XR|The pills were taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
383931|NCT00434876|O2|Outcome|Placebo|Placebo
383932|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
383933|NCT00434876|O2|Outcome|Placebo|Placebo
383934|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
383935|NCT00434876|O2|Outcome|Placebo|Placebo
383936|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
383937|NCT00434876|O2|Outcome|Placebo|Placebo
383938|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
383939|NCT00434876|E2|Reported Event|Placebo|Placebo
383940|NCT00434876|E1|Reported Event|Quetiapine|Quetiapine XR
383941|NCT00434954|B3|Baseline|Total|Total of all reporting groups
383942|NCT00434954|B2|Baseline|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383943|NCT00434954|B1|Baseline|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383944|NCT00434954|P2|Participant Flow|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383945|NCT00434954|P1|Participant Flow|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383946|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383947|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383948|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383949|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383950|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383951|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383952|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383953|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383954|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383955|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383956|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383957|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383958|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383959|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383960|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383961|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383962|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383963|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383964|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383965|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383966|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383967|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383968|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383969|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383970|NCT00434954|E2|Reported Event|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
383971|NCT00434954|E1|Reported Event|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
383976|NCT00434967|B1|Baseline|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
383977|NCT00434967|P4|Participant Flow|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383978|NCT00434967|P3|Participant Flow|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
383979|NCT00434967|P2|Participant Flow|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383980|NCT00434967|P1|Participant Flow|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
383981|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383982|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
383983|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383984|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
383985|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383986|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
383987|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383988|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
383989|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383990|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
383991|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383992|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
383993|NCT00434967|E4|Reported Event|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383994|NCT00434967|E3|Reported Event|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
383995|NCT00434967|E2|Reported Event|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
383996|NCT00434967|E1|Reported Event|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
383997|NCT00441441|B3|Baseline|Total|Total of all reporting groups
383998|NCT00441441|B2|Baseline|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
383999|NCT00441441|B1|Baseline|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384000|NCT00441441|P2|Participant Flow|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384001|NCT00441441|P1|Participant Flow|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA)|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384002|NCT00441441|O2|Outcome|No Spacer|Participants who required a spacer and were in either treatment group
384003|NCT00441441|O1|Outcome|Spacer|Participants who did not use spacer and were in either treatment group
384004|NCT00441441|O2|Outcome|Spacer|Participants who required a spacer and were in either treatment group
384007|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384008|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384009|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384010|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384011|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384012|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384013|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384014|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384015|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384016|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384017|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384018|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384019|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384020|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384021|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384022|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
384023|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
384024|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
384025|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
384026|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
384027|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
384028|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
384029|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
384030|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
384031|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
384032|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
384033|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
384034|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384035|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384036|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384037|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384092|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384093|NCT00441480|O2|Outcome|Control|Corn oil
384140|NCT00441701|P1|Participant Flow|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) once daily (QD) for up to 12 weeks
384039|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384040|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384041|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384042|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384043|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384044|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384045|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384046|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone propionate 100 µg HFA (2inhalations of 50 µg), twice daily for 12 weeks.
384047|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg), twice daily for 12 weeks.
384048|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384049|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg), twice daily for 12 weeks.
384050|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384051|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384052|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384053|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384054|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384055|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384056|NCT00441441|E2|Reported Event|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
384057|NCT00441441|E1|Reported Event|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
384058|NCT00441467|B1|Baseline|Glufosfamide|"Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
384059|NCT00441467|P1|Participant Flow|Glufosfamide|"Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
384060|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
384061|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
384062|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
384063|NCT00441467|E1|Reported Event|Glufosfamide|"Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
384064|NCT00441480|B3|Baseline|Total|Total of all reporting groups
384065|NCT00441480|B2|Baseline|Control|Corn oil
384066|NCT00441480|B1|Baseline|PS-FO|plant sterols esterified to fish oil fatty acids
384067|NCT00441480|P2|Participant Flow|Control|Corn oil
384068|NCT00441480|P1|Participant Flow|PS-FO|plant sterols esterified to fish oil fatty acids
384069|NCT00441480|O2|Outcome|Control|Corn oil
384070|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384071|NCT00441480|O2|Outcome|Control|Corn oil
384072|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384073|NCT00441480|O2|Outcome|Control|Corn oil
384074|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384075|NCT00441480|O2|Outcome|Control|Corn oil
384076|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384077|NCT00441480|O2|Outcome|Control|Corn oil
384078|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384079|NCT00441480|O2|Outcome|Control|Corn oil
384080|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384081|NCT00441480|O2|Outcome|Control|Corn oil
384082|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384083|NCT00441480|O2|Outcome|Control|Corn oil
384084|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384085|NCT00441480|O2|Outcome|Control|Corn oil
384086|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384087|NCT00441480|O2|Outcome|Control|Corn oil
384088|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
384100|NCT00441545|P2|Participant Flow|Sevelamer HCl First|Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above).
384101|NCT00441545|P1|Participant Flow|Fosrenol First|Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below).
384102|NCT00441545|O2|Outcome|Sevelamer HCl|
384103|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
384104|NCT00441545|O2|Outcome|Sevelamer HCl|
384105|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
384106|NCT00441545|O2|Outcome|Sevelamer HCl|
384107|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
384108|NCT00441545|O2|Outcome|Sevelamer HCl|
384109|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
384110|NCT00441545|E2|Reported Event|Sevelamer HCl|Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above).
384111|NCT00441545|E1|Reported Event|Fosrenol|Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below).
384112|NCT00441558|B1|Baseline|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
384113|NCT00441558|P1|Participant Flow|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
384114|NCT00441558|O1|Outcome|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
384115|NCT00441558|E1|Reported Event|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
384116|NCT00441584|B1|Baseline|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
384117|NCT00441584|P1|Participant Flow|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
384118|NCT00441584|O1|Outcome|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
384119|NCT00441584|E1|Reported Event|PegIntron Plus REBETOL|
384120|NCT00441701|B11|Baseline|Total|Total of all reporting groups
384121|NCT00441701|B10|Baseline|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384122|NCT00441701|B9|Baseline|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384123|NCT00441701|B8|Baseline|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384124|NCT00441701|B7|Baseline|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384125|NCT00441701|B6|Baseline|Part 1: Placebo to Navarixin 30 mg|Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384126|NCT00441701|B5|Baseline|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384127|NCT00441701|B4|Baseline|Part 1: Placebo to Navarixin 10 mg|Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384128|NCT00441701|B3|Baseline|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384129|NCT00441701|B2|Baseline|Part 1: Placebo to Navarixin 3 mg|Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384130|NCT00441701|B1|Baseline|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384131|NCT00441701|P10|Participant Flow|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384132|NCT00441701|P9|Participant Flow|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384133|NCT00441701|P8|Participant Flow|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384134|NCT00441701|P7|Participant Flow|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384135|NCT00441701|P6|Participant Flow|Part 1: Placebo to Navarixin 30 mg|Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384136|NCT00441701|P5|Participant Flow|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384137|NCT00441701|P4|Participant Flow|Part 1: Placebo to Navarixin 10 mg|Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384138|NCT00441701|P3|Participant Flow|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384139|NCT00441701|P2|Participant Flow|Part 1: Placebo to Navarixin 3 mg|Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384846|NCT00445432|O3|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
384142|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384143|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384144|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384145|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384146|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384147|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384148|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384149|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384150|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384151|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384152|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384153|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384154|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384155|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384156|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384157|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384158|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384159|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384160|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384161|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384162|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384163|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384164|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384165|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384166|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384167|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384168|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384169|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384170|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384171|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384172|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384173|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384174|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384175|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384176|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384177|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384178|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384179|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384180|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384181|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384182|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384183|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384184|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384185|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384186|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384187|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384188|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384189|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384190|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384191|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384192|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384193|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384194|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384195|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384196|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384197|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384198|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384199|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384200|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384201|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384202|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384203|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384204|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384205|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384206|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384207|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384208|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384209|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384210|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384211|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384212|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384213|NCT00441701|E8|Reported Event|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384214|NCT00441701|E7|Reported Event|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384215|NCT00441701|E6|Reported Event|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384216|NCT00441701|E5|Reported Event|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384217|NCT00441701|E4|Reported Event|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
384218|NCT00441701|E3|Reported Event|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
384219|NCT00441701|E2|Reported Event|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
384220|NCT00441701|E1|Reported Event|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
384221|NCT00444457|B5|Baseline|Total|Total of all reporting groups
384222|NCT00444457|B4|Baseline|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384309|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384847|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
384313|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384223|NCT00444457|B3|Baseline|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384224|NCT00444457|B2|Baseline|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384225|NCT00444457|B1|Baseline|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384226|NCT00444457|P4|Participant Flow|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384227|NCT00444457|P3|Participant Flow|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384228|NCT00444457|P2|Participant Flow|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384229|NCT00444457|P1|Participant Flow|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384230|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384231|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384707|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
384232|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384233|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384234|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384235|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384236|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384237|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384238|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384239|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384240|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384241|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384242|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384243|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384244|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384310|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384708|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384245|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384246|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384247|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384248|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384249|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384250|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384251|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384252|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384253|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384254|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384255|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384256|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384257|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
384311|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384834|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
384258|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384259|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384260|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384261|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384262|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384263|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384264|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384265|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384266|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384835|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
384267|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384268|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384269|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384270|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384271|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384272|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384273|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384274|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384275|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384312|NCT00444587|O2|Outcome|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
384276|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384277|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384278|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384279|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
384280|NCT00444457|E10|Reported Event|Post Toddler Dose 6-Month Follow-up 7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).
384281|NCT00444457|E9|Reported Event|Post Toddler Dose 6-Month Follow-up Combined 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).
384282|NCT00444457|E8|Reported Event|Toddler Dose 7vPnC|"Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=75; systematic (solicited) Local Reactions N=83; systematic (solicited) Systemic Events N=128."
384283|NCT00444457|E7|Reported Event|Toddler Dose Combined 13vPnC|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=434; systematic (solicited) Local Reactions N=473; systematic (solicited) Systemic Events N=771."
384284|NCT00444457|E6|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).
384285|NCT00444457|E5|Reported Event|After the Infant Series Combined 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).
384438|NCT00444626|E6|Reported Event|Non-NLF: Repeat Treatment Period|Adverse events that did not occur at the nasolabial folds, and occurred during the Repeat Treatment Period regardless to relationship to DGE treatment.
384286|NCT00444457|E4|Reported Event|Infant Series 7vPnC|"Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=207; systematic (solicited) Local Reactions N=142; systematic (solicited) Systemic Events N=198."
384287|NCT00444457|E3|Reported Event|Infant Series 13vPnC (Manufacturing Lot)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=402; systematic (solicited) Local Reactions N=250; systematic (solicited) Systemic Events N=386."
384288|NCT00444457|E2|Reported Event|Infant Series 13vPnC (Pilot Lot 2)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=394; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=364."
384289|NCT00444457|E1|Reported Event|Infant Series 13vPnC (Pilot Lot 1)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=407; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=373."
384290|NCT00444535|B1|Baseline|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
384291|NCT00444535|P1|Participant Flow|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
384292|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
384293|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
384294|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
384295|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
384296|NCT00444535|E1|Reported Event|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
384297|NCT00444587|B3|Baseline|Total|Total of all reporting groups
384298|NCT00444587|B2|Baseline|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
384299|NCT00444587|B1|Baseline|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
384300|NCT00444587|P2|Participant Flow|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
384301|NCT00444587|P1|Participant Flow|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab (Herceptin) 6 milligrams per kilograms (mg/kg) of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous (IV) infusion every three weeks until disease progression, unacceptable toxicities, or withdrawal from study, in combination with second line chemotherapy.
384302|NCT00444587|O2|Outcome|Only Chemotherapy|Eligible participants received second line chemotherapy according to the investigator's decision.
384303|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384304|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384305|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384306|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384307|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384308|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
397467|NCT00477295|B3|Baseline|Total|Total of all reporting groups
384314|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384315|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384316|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384317|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
384318|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
384319|NCT00444587|E2|Reported Event|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
384320|NCT00444587|E1|Reported Event|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
384321|NCT00444600|B5|Baseline|Total|Total of all reporting groups
384322|NCT00444600|B4|Baseline|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384323|NCT00444600|B3|Baseline|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384324|NCT00444600|B2|Baseline|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384325|NCT00444600|B1|Baseline|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384326|NCT00444600|P4|Participant Flow|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384327|NCT00444600|P3|Participant Flow|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384328|NCT00444600|P2|Participant Flow|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384329|NCT00444600|P1|Participant Flow|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384330|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384331|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384332|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384333|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384334|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384335|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384336|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
397817|NCT00478036|B4|Baseline|Total|Total of all reporting groups
384337|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384338|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384339|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384340|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384341|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384342|NCT00444600|O3|Outcome|Triamcinolone|
384343|NCT00444600|O2|Outcome|Ranibizumab|
384344|NCT00444600|O1|Outcome|Sham|
384345|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384346|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384347|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384348|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384349|NCT00444600|O3|Outcome|Triamcinolone|
384350|NCT00444600|O2|Outcome|Ranibizumab|
384351|NCT00444600|O1|Outcome|Sham|
384352|NCT00444600|O3|Outcome|Triamcinolone|
384353|NCT00444600|O2|Outcome|Ranibizumab|
384354|NCT00444600|O1|Outcome|Sham|
384355|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384356|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384357|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384358|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384359|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384360|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384361|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384362|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384363|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384364|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384365|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384366|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384478|NCT00444912|E2|Reported Event|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384836|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
384367|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384368|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384369|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384370|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384371|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384372|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384373|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384374|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384375|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384376|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384377|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384378|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384379|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384380|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384381|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384382|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384383|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384384|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384385|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384386|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384387|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384388|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384389|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384479|NCT00444912|E1|Reported Event|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384390|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384391|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384392|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384393|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384394|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384395|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384396|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384397|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384398|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384399|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384400|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384401|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384402|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384403|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384404|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384405|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384406|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384407|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384408|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
384409|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384410|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
384411|NCT00444600|E7|Reported Event|Sham + Triamcinolone + Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
384480|NCT00444925|B4|Baseline|Total|Total of all reporting groups
384481|NCT00444925|B3|Baseline|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384439|NCT00444626|E5|Reported Event|Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period|Adverse events that occurred at the nasolabial fold that was treated with Restylane in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.
384412|NCT00444600|E6|Reported Event|Sham + Ranibizumab + Deferred Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
384413|NCT00444600|E5|Reported Event|Sham + Ranibizumab + Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
384414|NCT00444600|E4|Reported Event|Triamcinolone + Prompt Laser|4 mg intravitreal triamcinolone plus prompt (within 3–10 days after injection) focal/grid photocoagulation
384415|NCT00444600|E3|Reported Event|Ranibizumab + Deferred Laser|0.5 mg intravitreal ranibizumab with deferred (24 weeks) focal/grid photocoagulation
384416|NCT00444600|E2|Reported Event|Ranibizumab + Prompt Laser|0.5 mg intravitreal ranibizumab plus prompt (within 3–10 days after injection) focal/grid photocoagulation
384417|NCT00444600|E1|Reported Event|Sham + Prompt Laser|Laser was given within 3 to 10 days after sham injections, Laser = Focal/grid photocoagulation
384418|NCT00444626|B1|Baseline|Combined Arms|Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
384419|NCT00444626|P1|Participant Flow|Combined Arm|Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
384420|NCT00444626|O3|Outcome|Non-NLF|Adverse events that did not occur at the nasolabial folds
384421|NCT00444626|O2|Outcome|Restylane - Dermal Gel Extra (DGE)|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. In the Repeat Treatment Period, participants received DGE on both sides of their face. This represents the experience with DGE for the side of the face that was originally treated with Restylane.
384422|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
384423|NCT00444626|O3|Outcome|Non-NLF|Adverse events that did not occur at the nasolabial folds
384424|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
384425|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
384426|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
384427|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
384428|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
384429|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
384430|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
384431|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
384432|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
384433|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
384434|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
384435|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
384436|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
384437|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
384482|NCT00444925|B2|Baseline|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384440|NCT00444626|E4|Reported Event|Dermal Gel Extra (DGE) - Repeat Treatment Period|Adverse events that occurred at the nasolabial fold that was treated with DGE in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.
384441|NCT00444626|E3|Reported Event|Non-NLF: Initial Treatment Period|Adverse events that did not occur at the nasolabial folds, and occurred during the Initial Treatment Period regardless to relationship to either DGE or Restylane treatment.
384442|NCT00444626|E2|Reported Event|Restylane: Initial Treatment Period|Adverse events that occurred at the nasolabial fold treated with Restylane, and occurred during the Initial Treatment Period regardless of relationship to Restylane treatment.
384443|NCT00444626|E1|Reported Event|Dermal Gel Extra (DGE): Initial Treatment Period|Adverse events that occurred at the nasolabial fold treated with DGE, and occurred during the Initial Treatment Period regardless of relationship to DGE treatment.
384444|NCT00444795|B1|Baseline|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
384445|NCT00444795|P1|Participant Flow|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
384446|NCT00444795|O1|Outcome|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
384447|NCT00444795|O1|Outcome|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
384448|NCT00444795|E1|Reported Event|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
384449|NCT00444912|B3|Baseline|Total|Total of all reporting groups
384450|NCT00444912|B2|Baseline|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384451|NCT00444912|B1|Baseline|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384452|NCT00444912|P2|Participant Flow|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384453|NCT00444912|P1|Participant Flow|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384454|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384455|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384456|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384457|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384458|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384459|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384460|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384461|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384462|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384463|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384464|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384465|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384466|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384467|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384468|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384469|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384470|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384471|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384472|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384473|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384474|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384475|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
384476|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
384477|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
397818|NCT00478036|B3|Baseline|Predforte Group|Used predforte eye drops
384483|NCT00444925|B1|Baseline|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
442801|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
384484|NCT00444925|P3|Participant Flow|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384485|NCT00444925|P2|Participant Flow|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384486|NCT00444925|P1|Participant Flow|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384487|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384488|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384489|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384490|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384491|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384492|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384493|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384494|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384495|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384496|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384497|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384498|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384499|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384500|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384501|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384502|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384503|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384504|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384505|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384506|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384507|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384508|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384509|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384510|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384511|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384512|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384513|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384514|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384515|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384516|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384517|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384518|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384519|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384520|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384521|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384522|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384523|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384524|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384525|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384526|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384527|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384528|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384529|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384530|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384531|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384532|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384533|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384534|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384535|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384536|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384537|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384538|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384539|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384540|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384541|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384542|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384543|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384544|NCT00444925|E3|Reported Event|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
384545|NCT00444925|E2|Reported Event|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
384546|NCT00444925|E1|Reported Event|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
384547|NCT00444951|B4|Baseline|Total|Total of all reporting groups
384548|NCT00444951|B3|Baseline|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
384549|NCT00444951|B2|Baseline|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
384550|NCT00444951|B1|Baseline|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
384551|NCT00444951|P3|Participant Flow|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
384552|NCT00444951|P2|Participant Flow|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
384553|NCT00444951|P1|Participant Flow|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
384554|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
384555|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
384556|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
384557|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
384558|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
384559|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
384560|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
384605|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384709|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384561|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
384562|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
384563|NCT00444951|E3|Reported Event|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
384564|NCT00444951|E2|Reported Event|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
384565|NCT00444951|E1|Reported Event|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
384566|NCT00445003|B4|Baseline|Total|Total of all reporting groups
384567|NCT00445003|B3|Baseline|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
384568|NCT00445003|B2|Baseline|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
384569|NCT00445003|B1|Baseline|Sham Injection|Sham injection at baseline and 4 weeks
384570|NCT00445003|P3|Participant Flow|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
384571|NCT00445003|P2|Participant Flow|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
384572|NCT00445003|P1|Participant Flow|Sham Injection|Sham injection at baseline and 4 weeks
384573|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
384574|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
384575|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
384576|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
384577|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
384578|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
384579|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
384580|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
384581|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
384582|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
384583|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
384584|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
384585|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
384586|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
384587|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
384588|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
384589|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
384590|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
384591|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
384592|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
384593|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
384594|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
384595|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
384596|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
384597|NCT00445003|E3|Reported Event|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
384598|NCT00445003|E2|Reported Event|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
384599|NCT00445003|E1|Reported Event|Sham Injection|Sham injection at baseline and 4 weeks
384600|NCT00445146|B1|Baseline|EVG+RTV|EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2.
384601|NCT00445146|P1|Participant Flow|EVG+RTV|"Elvitegravir (EVG) 85 or 150 mg tablet boosted with ritonavir (RTV; r/) 100 mg capsule once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384602|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384603|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384604|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384606|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384607|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384608|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384609|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384610|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384611|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384612|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384613|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384614|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384615|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384616|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384617|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384618|NCT00445146|E1|Reported Event|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule administered orally once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.
Some participants may have received EVG 300 mg during the course of protocol amendment 2."
384619|NCT00445211|B3|Baseline|Total|Total of all reporting groups
384620|NCT00445211|B2|Baseline|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin
Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
384621|NCT00445211|B1|Baseline|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin
Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
384622|NCT00445211|P2|Participant Flow|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin
Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
384623|NCT00445211|P1|Participant Flow|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin
Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
384624|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin
Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
384625|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin
Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
384626|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin
Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
384627|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin
Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
384628|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin
Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
384629|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin
Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
384630|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin
Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
384631|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin
Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
384632|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin
Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
384633|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin
Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
384634|NCT00445211|E2|Reported Event|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin
Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
384635|NCT00445211|E1|Reported Event|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin
Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
384636|NCT00445224|B3|Baseline|Total|Total of all reporting groups
384637|NCT00445224|B2|Baseline|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384638|NCT00445224|B1|Baseline|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384639|NCT00445224|P2|Participant Flow|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384640|NCT00445224|P1|Participant Flow|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384641|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384642|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384643|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384644|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384645|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384646|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384647|NCT00445224|E2|Reported Event|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384648|NCT00445224|E1|Reported Event|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
384649|NCT00445263|B3|Baseline|Total|Total of all reporting groups
384650|NCT00445263|B2|Baseline|Delayed Invasive Strategy|Coronarography after six hours
384651|NCT00445263|B1|Baseline|Early Invasive Strategy|Tirofiban and coronarography within six hours
384652|NCT00445263|P2|Participant Flow|Delayed Invasive Strategy|Coronarography after six hours
384653|NCT00445263|P1|Participant Flow|Early Invasive Strategy|Tirofiban and coronarography within six hours
384654|NCT00445263|O2|Outcome|Delayed Invasive Strategy|Coronarography after six hours
384655|NCT00445263|O1|Outcome|Early Invasive Strategy|Tirofiban and coronarography within six hours
384656|NCT00445263|E2|Reported Event|Delayed Invasive Strategy|Coronarography after six hours
384657|NCT00445263|E1|Reported Event|Early Invasive Strategy|Tirofiban and coronarography within six hours
384658|NCT00445302|B5|Baseline|Total|Total of all reporting groups
384659|NCT00445302|B4|Baseline|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384660|NCT00445302|B3|Baseline|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384661|NCT00445302|B2|Baseline|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384662|NCT00445302|B1|Baseline|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384663|NCT00445302|P4|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384664|NCT00445302|P3|Participant Flow|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384665|NCT00445302|P2|Participant Flow|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384666|NCT00445302|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384667|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384668|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384669|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384670|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384671|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384672|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384706|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384673|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384674|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384675|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384676|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384677|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384678|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384679|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384680|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384681|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384682|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384683|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384684|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384685|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384686|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384687|NCT00445302|E4|Reported Event|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384688|NCT00445302|E3|Reported Event|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384689|NCT00445302|E2|Reported Event|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384690|NCT00445302|E1|Reported Event|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
384691|NCT00445315|B6|Baseline|Total|Total of all reporting groups
384692|NCT00445315|B5|Baseline|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
384693|NCT00445315|B4|Baseline|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384694|NCT00445315|B3|Baseline|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384695|NCT00445315|B2|Baseline|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384696|NCT00445315|B1|Baseline|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384697|NCT00445315|P5|Participant Flow|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
384698|NCT00445315|P4|Participant Flow|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384699|NCT00445315|P3|Participant Flow|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384700|NCT00445315|P2|Participant Flow|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384701|NCT00445315|P1|Participant Flow|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384702|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
384703|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384704|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384705|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384837|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
384710|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384711|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384712|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
384713|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384714|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384715|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384716|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384717|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
384718|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384719|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384720|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384721|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384722|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
384723|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384724|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384725|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384726|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384727|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384728|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384729|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384730|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384731|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384732|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384733|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384734|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384735|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384736|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384737|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384738|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384739|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384740|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384741|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384742|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384743|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384744|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384745|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384746|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384747|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384748|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384749|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384750|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384751|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384752|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384753|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384754|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384755|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384756|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384757|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384758|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384759|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384760|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384761|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384762|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384763|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384764|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384765|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384766|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384767|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384768|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384769|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384770|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384771|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384772|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384773|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384774|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384775|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384776|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384777|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384778|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384779|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384780|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384781|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384782|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384783|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384784|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384785|NCT00445315|E5|Reported Event|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
384786|NCT00445315|E4|Reported Event|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384787|NCT00445315|E3|Reported Event|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
384838|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
384788|NCT00445315|E2|Reported Event|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384789|NCT00445315|E1|Reported Event|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
384790|NCT00445328|B3|Baseline|Total|Total of all reporting groups
384791|NCT00445328|B2|Baseline|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
384792|NCT00445328|B1|Baseline|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
384793|NCT00445328|P2|Participant Flow|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
384794|NCT00445328|P1|Participant Flow|Dalteparin|5000 IU (International Units) dalteparin in 0.2 mL (milliliters) subcutaneously once a day (Arm A)
384795|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
384796|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
384797|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
384798|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
384799|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
384800|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
384801|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
384802|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
384803|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
384804|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
384805|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
384806|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
384807|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
384808|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
384809|NCT00445328|E2|Reported Event|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
384810|NCT00445328|E1|Reported Event|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
384811|NCT00445341|B1|Baseline|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
384812|NCT00445341|P1|Participant Flow|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
384813|NCT00445341|O1|Outcome|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
384814|NCT00445341|O1|Outcome|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
384815|NCT00445341|E1|Reported Event|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
384816|NCT00445432|B4|Baseline|Total|Total of all reporting groups
384817|NCT00445432|B3|Baseline|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
384818|NCT00445432|B2|Baseline|Placebo Eow|Double-blind adalimumab placebo every other week
384819|NCT00445432|B1|Baseline|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
384820|NCT00445432|P4|Participant Flow|Any Adalimumab|All participants in NCT00445432 (Study M06-837) who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
384821|NCT00445432|P3|Participant Flow|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
384822|NCT00445432|P2|Participant Flow|Placebo Eow|Double-blind adalimumab placebo every other week
384823|NCT00445432|P1|Participant Flow|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
384824|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
384825|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
384826|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
384827|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
384828|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
384829|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
384830|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
384831|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
384832|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
384833|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
384848|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
384849|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
384851|NCT00445432|E4|Reported Event|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
384852|NCT00445432|E3|Reported Event|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
384853|NCT00445432|E2|Reported Event|Placebo Eow|Double-blind adalimumab placebo every other week
384854|NCT00445432|E1|Reported Event|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
384855|NCT00445484|B3|Baseline|Total|Total of all reporting groups
384856|NCT00445484|B2|Baseline|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384857|NCT00445484|B1|Baseline|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384858|NCT00445484|P2|Participant Flow|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384859|NCT00445484|P1|Participant Flow|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384860|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384861|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384862|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384863|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384864|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384865|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384866|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384867|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384868|NCT00445484|E2|Reported Event|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384869|NCT00445484|E1|Reported Event|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
pneumococcal polyvalent vaccine: Given intramuscularly
lenalidomide: Given orally"
384870|NCT00445549|B1|Baseline|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
384871|NCT00445549|P1|Participant Flow|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
384872|NCT00445549|O1|Outcome|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
384873|NCT00445549|O1|Outcome|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
384874|NCT00445549|E1|Reported Event|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
384927|NCT00445705|P3|Participant Flow|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
384928|NCT00445705|P2|Participant Flow|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
384929|NCT00445705|P1|Participant Flow|Placebo|Part A: Placebo every 12 hours for 4 weeks
384875|NCT00445588|B1|Baseline|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study
erlotinib hydrochloride: 150mg Given orally once daily
sorafenib tosylate: 400mg Given orally twice daily
pharmacological study: Correlative studies"
384876|NCT00445588|P1|Participant Flow|Treatment|"Patients receive oral erlotinib hydrochloride 150 mg once daily and oral sorafenib tosylate 400 mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study
erlotinib hydrochloride 150mg: Given orally once daily
sorafenib tosylate 400mg: Given orally twice daily
pharmacological study: Correlative studies"
384877|NCT00445588|O1|Outcome|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study
erlotinib hydrochloride: 150mg Given orally once daily
sorafenib tosylate: 400mg Given orally twice daily
pharmacological study: Correlative studies"
384878|NCT00445588|O1|Outcome|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study
erlotinib hydrochloride 150mg: Given orally once daily
sorafenib tosylate 400mg: Given orally twice daily
pharmacological study: Correlative studies"
384879|NCT00445588|E1|Reported Event|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study
erlotinib hydrochloride: 150mg Given orally once daily
sorafenib tosylate: 400mg Given orally twice daily
pharmacological study: Correlative studies"
384880|NCT00445679|B5|Baseline|Total|Total of all reporting groups
384881|NCT00445679|B4|Baseline|Paroxetine 20|Paroxetine 20 mg/day
384882|NCT00445679|B3|Baseline|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
384883|NCT00445679|B2|Baseline|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
384884|NCT00445679|B1|Baseline|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
384885|NCT00445679|P4|Participant Flow|Paroxetine 20|Paroxetine 20 mg/day
384886|NCT00445679|P3|Participant Flow|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
384887|NCT00445679|P2|Participant Flow|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
384888|NCT00445679|P1|Participant Flow|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
384889|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
384890|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
384891|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
384892|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
384893|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
384894|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
384895|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
384896|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
384897|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
384898|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
384899|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
384900|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
384901|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
384902|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
384903|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
384904|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
384905|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
384906|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
384907|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
384908|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
384909|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
384910|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
384911|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
384912|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
384913|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
384914|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
384915|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
384916|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
384917|NCT00445679|E4|Reported Event|Paroxetine 20|Paroxetine 20 mg/day
384918|NCT00445679|E3|Reported Event|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
384919|NCT00445679|E2|Reported Event|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
384920|NCT00445679|E1|Reported Event|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
384921|NCT00445705|B5|Baseline|Total|Total of all reporting groups
384922|NCT00445705|B4|Baseline|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
384923|NCT00445705|B3|Baseline|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
384924|NCT00445705|B2|Baseline|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
384925|NCT00445705|B1|Baseline|Placebo|Part A: Placebo every 12 hours for 4 weeks
384926|NCT00445705|P4|Participant Flow|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
384939|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
384940|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
384941|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
384942|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
384943|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
384944|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
384945|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
384946|NCT00445705|E4|Reported Event|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
384947|NCT00445705|E3|Reported Event|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
384948|NCT00445705|E2|Reported Event|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
384949|NCT00445705|E1|Reported Event|Placebo|Part A: Placebo every 12 hours for 4 weeks
384950|NCT00445770|B4|Baseline|Total|Total of all reporting groups
384951|NCT00445770|B3|Baseline|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384952|NCT00445770|B2|Baseline|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384953|NCT00445770|B1|Baseline|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384954|NCT00445770|P3|Participant Flow|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384955|NCT00445770|P2|Participant Flow|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384956|NCT00445770|P1|Participant Flow|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384957|NCT00445770|O2|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384958|NCT00445770|O1|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384959|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384960|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384961|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384962|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384963|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384964|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384965|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384966|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384967|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384968|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384969|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384970|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384971|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384972|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384973|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384974|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384975|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384976|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384977|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
397819|NCT00478036|B2|Baseline|Acular Group|Used acular LS
384978|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384979|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384980|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384981|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384982|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384983|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384984|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
385026|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
384985|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384986|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384987|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384988|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384989|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384990|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384991|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384992|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384993|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384994|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384995|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384996|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
384997|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
384998|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
384999|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
385000|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
385001|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
385002|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
385003|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
385004|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
385005|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
385006|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
385007|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
385008|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
385009|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
385010|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
385011|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
385012|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
385013|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
385014|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
385015|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
385016|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
385017|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
385018|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
385019|NCT00445770|E3|Reported Event|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
386447|NCT00449865|E1|Reported Event|Placebo|placebo: an inactive substance
385020|NCT00445770|E2|Reported Event|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
385021|NCT00445770|E1|Reported Event|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
385022|NCT00445848|B1|Baseline|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
385023|NCT00445848|P1|Participant Flow|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
385024|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
385025|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
385859|NCT00448123|P2|Participant Flow|Tamsulosin|Tamsulosin orally 0.4 mg/daily for up to 10 days.
385027|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
385028|NCT00445848|E1|Reported Event|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
385029|NCT00445939|B4|Baseline|Total|Total of all reporting groups
385030|NCT00445939|B3|Baseline|Placebo|Placebo at Week 0, placebo Week 2
385031|NCT00445939|B2|Baseline|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
385032|NCT00445939|B1|Baseline|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
385033|NCT00445939|P4|Participant Flow|Adalimumab 40mg /40 mg|Non-responders continued after 4 weeks, Adalimumab 160 at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6; Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6.
385034|NCT00445939|P3|Participant Flow|Placebo|Placebo at Week 0, placebo at Week 2
385035|NCT00445939|P2|Participant Flow|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
385036|NCT00445939|P1|Participant Flow|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
385037|NCT00445939|O3|Outcome|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
385038|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
385039|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
385040|NCT00445939|O3|Outcome|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, placebo at Week 2, adalimumab 160 mg at Week 4, and adalimumab 80 mg at Week 6
385041|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6
385042|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6
385043|NCT00445939|O3|Outcome|Placebo|Placebo at Week 0, placebo at Week 2,
385044|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
385045|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
385046|NCT00445939|O3|Outcome|Placebo + 160/80 mg|Placebo at Week 0, placebo at Week 2
385047|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
385048|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
385049|NCT00445939|O3|Outcome|Placebo|Placebo at Week 0, placebo at Week 2
385050|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
385051|NCT00445939|O1|Outcome|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
385052|NCT00445939|E6|Reported Event|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, Placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
385053|NCT00445939|E5|Reported Event|80/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
385054|NCT00445939|E4|Reported Event|Adalimumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
385055|NCT00445939|E3|Reported Event|Placebo|Placebo at Week 0, placebo at Week 2
385056|NCT00445939|E2|Reported Event|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
385057|NCT00445939|E1|Reported Event|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
385058|NCT00446030|B3|Baseline|Total|Total of all reporting groups
385059|NCT00446030|B2|Baseline|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
385060|NCT00446030|B1|Baseline|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
385061|NCT00446030|P2|Participant Flow|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
385062|NCT00446030|P1|Participant Flow|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
385063|NCT00446030|O2|Outcome|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
385064|NCT00446030|O1|Outcome|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
386448|NCT00449930|B3|Baseline|Total|Total of all reporting groups
385065|NCT00446030|O2|Outcome|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
385066|NCT00446030|O1|Outcome|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
385067|NCT00446030|E2|Reported Event|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
385068|NCT00446030|E1|Reported Event|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
385069|NCT00446095|B6|Baseline|Total|Total of all reporting groups
385070|NCT00446095|B5|Baseline|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
385071|NCT00446095|B4|Baseline|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
385072|NCT00446095|B3|Baseline|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
385073|NCT00446095|B2|Baseline|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
385074|NCT00446095|B1|Baseline|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
385075|NCT00446095|P5|Participant Flow|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
385076|NCT00446095|P4|Participant Flow|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
385077|NCT00446095|P3|Participant Flow|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
385078|NCT00446095|P2|Participant Flow|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
385079|NCT00446095|P1|Participant Flow|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
385080|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
385081|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
385082|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
385083|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
385084|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
385085|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
385086|NCT00446095|O4|Outcome|Phase 1: 200mg and 250mg R788 BID|Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
385087|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
385088|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
385089|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
385090|NCT00446095|O4|Outcome|Phase 1: 200mg and 250mg R788 BID|Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
385091|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
385092|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
385093|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
385094|NCT00446095|E5|Reported Event|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
385095|NCT00446095|E4|Reported Event|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
385096|NCT00446095|E3|Reported Event|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
385097|NCT00446095|E2|Reported Event|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
385098|NCT00446095|E1|Reported Event|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
385099|NCT00446134|B5|Baseline|Total|Total of all reporting groups
385100|NCT00446134|B4|Baseline|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385101|NCT00446134|B3|Baseline|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385102|NCT00446134|B2|Baseline|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385103|NCT00446134|B1|Baseline|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
386604|NCT00442338|O2|Outcome|Montelukast 14 mg|Montelukast 14 mg IV Administration
385104|NCT00446134|P4|Participant Flow|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385105|NCT00446134|P3|Participant Flow|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385106|NCT00446134|P2|Participant Flow|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385107|NCT00446134|P1|Participant Flow|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385108|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385109|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385110|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385111|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385112|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385113|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385114|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385115|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385116|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385117|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385118|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385119|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385120|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385121|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385122|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385123|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385124|NCT00446134|E4|Reported Event|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385125|NCT00446134|E3|Reported Event|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385126|NCT00446134|E2|Reported Event|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385127|NCT00446134|E1|Reported Event|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
385128|NCT00446147|B3|Baseline|Total|Total of all reporting groups
385129|NCT00446147|B2|Baseline|Pyridoxine|"100 mg twice per day
Pyridoxine: 100mg BID/daily, Per oral"
385130|NCT00446147|B1|Baseline|Placebo|"one tablet twice per day, which is identical to pyridoxine
Placebo: placebo 100mg BID/daily, Per oral"
385131|NCT00446147|P2|Participant Flow|Pyridoxine|"100 mg twice per day
Pyridoxine: 100mg BID/daily, Per oral"
385132|NCT00446147|P1|Participant Flow|Placebo|"one tablet twice per day, which is identical to pyridoxine
Placebo: placebo 100mg BID/daily, Per oral"
385133|NCT00446147|O2|Outcome|Pyridoxine|"100 mg twice per day
Pyridoxine: 100mg BID/daily, Per oral"
385134|NCT00446147|O1|Outcome|Placebo|"one tablet twice per day, which is identical to pyridoxine
Placebo: placebo 100mg BID/daily, Per oral"
385135|NCT00446147|O2|Outcome|Pyridoxine|"100 mg twice per day
Pyridoxine: 100mg BID/daily, Per oral"
385136|NCT00446147|O1|Outcome|Placebo|"one tablet twice per day, which is identical to pyridoxine
Placebo: placebo 100mg BID/daily, Per oral"
385137|NCT00446147|E2|Reported Event|Pyridoxine|"100 mg twice per day
Pyridoxine: 100mg BID/daily, Per oral"
385138|NCT00446147|E1|Reported Event|Placebo|"one tablet twice per day, which is identical to pyridoxine
Placebo: placebo 100mg BID/daily, Per oral"
385139|NCT00446199|B5|Baseline|Total|Total of all reporting groups
399156|NCT00479557|B8|Baseline|Total|Total of all reporting groups
385140|NCT00446199|B4|Baseline|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385141|NCT00446199|B3|Baseline|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385142|NCT00446199|B2|Baseline|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385143|NCT00446199|B1|Baseline|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385144|NCT00446199|P4|Participant Flow|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385145|NCT00446199|P3|Participant Flow|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385146|NCT00446199|P2|Participant Flow|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385860|NCT00448123|P1|Participant Flow|Placebo|None active placebo orally per day for up to 10 days.
385147|NCT00446199|P1|Participant Flow|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385148|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385149|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385150|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385151|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385152|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385153|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385154|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385155|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385156|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385157|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385158|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385159|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385160|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385161|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385162|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385163|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385164|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385165|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385166|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385167|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385168|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385169|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385170|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385171|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385172|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385173|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385174|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385175|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385176|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385177|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385178|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385179|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385180|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385181|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385182|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385529|NCT00438464|B2|Baseline|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385183|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385184|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385185|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385186|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385187|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385188|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385189|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385190|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385191|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385192|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385193|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385194|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385195|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385196|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385197|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385198|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385199|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385200|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385201|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385202|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385203|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385204|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385205|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385206|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385207|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385208|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385209|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385210|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385211|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385212|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385213|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385214|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385215|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385216|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385217|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
385218|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385219|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385220|NCT00446199|E4|Reported Event|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
385221|NCT00446199|E3|Reported Event|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle)
385222|NCT00446199|E2|Reported Event|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385223|NCT00446199|E1|Reported Event|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
385224|NCT00446251|B1|Baseline|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
385583|NCT00438490|B3|Baseline|Total|Total of all reporting groups
385225|NCT00446251|P1|Participant Flow|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
385226|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
385227|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
385228|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
385229|NCT00446251|E1|Reported Event|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
385230|NCT00446264|B1|Baseline|Single Arm Group|Islet Allotransplantation Group
385231|NCT00446264|P1|Participant Flow|Single Arm Group|Islet Allotransplantation Group
385232|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
385233|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
385234|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
385235|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
385236|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
385237|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
385238|NCT00446264|E1|Reported Event|Single Arm Group|Islet Allotransplantation Group
385239|NCT00446290|B1|Baseline|DXP Arm|Docetaxel, capecitabine and oxaliplatin
385240|NCT00446290|P1|Participant Flow|DXO Arm|"Docetaxel, capecitabine and oxaliplatin
Dose level Docetaxel(mg/m2) Capecitabine(mg/m2, twice daily) Oxaliplatin(mg/m2)
45 800 100
60 800 100
60 1,000 100
60 800 130
60 1,000 130"
385241|NCT00446290|O1|Outcome|DXO Arm|Docetaxel, capecitabine and oxaliplatin
385242|NCT00446290|E1|Reported Event|DXO Arm|Docetaxel, capecitabine and oxaliplatin
385243|NCT00446446|B1|Baseline|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
385244|NCT00446446|P1|Participant Flow|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
385245|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
385246|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
385247|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
385248|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
385249|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
385250|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
385251|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
385252|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
385253|NCT00446446|E1|Reported Event|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
385254|NCT00446459|B1|Baseline|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
385255|NCT00446459|P1|Participant Flow|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
385256|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
385257|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
385258|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
385259|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
385260|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
385261|NCT00446459|E1|Reported Event|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
385262|NCT00446511|B5|Baseline|Total|Total of all reporting groups
385263|NCT00446511|B4|Baseline|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385264|NCT00446511|B3|Baseline|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385265|NCT00446511|B2|Baseline|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385266|NCT00446511|B1|Baseline|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385267|NCT00446511|P4|Participant Flow|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385268|NCT00446511|P3|Participant Flow|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385269|NCT00446511|P2|Participant Flow|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385270|NCT00446511|P1|Participant Flow|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385271|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385272|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385273|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385274|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385275|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385276|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385277|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385278|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385279|NCT00446511|O2|Outcome|Non-CKD Patients: Enalapril|All non-CKD patients assigned to enalapril in the core study (CVAL489K2302) continued their monotherapy treatment of enalapril 10/20/40 mg stratified by weight.
385280|NCT00446511|O1|Outcome|Non-CKD Patients: Valsartan|All non-CKD patients assigned to valsartan in the core study (CVAL489K2302) continued their monotherapy treatment of valsartan 80/160/320 mg stratified by weight.
385281|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385282|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385303|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385283|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385284|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385285|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385286|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385287|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385288|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385289|NCT00446511|E4|Reported Event|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385290|NCT00446511|E3|Reported Event|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385291|NCT00446511|E2|Reported Event|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385292|NCT00446511|E1|Reported Event|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
385293|NCT00446563|B3|Baseline|Total|Total of all reporting groups
385294|NCT00446563|B2|Baseline|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385295|NCT00446563|B1|Baseline|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385296|NCT00446563|P2|Participant Flow|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385297|NCT00446563|P1|Participant Flow|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385298|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385299|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385300|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385301|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385302|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385304|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385305|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385306|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
442802|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
385307|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385308|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385309|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385310|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385311|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385312|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385313|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385314|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385315|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385316|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385317|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385318|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385319|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385320|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385321|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385322|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385323|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385324|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385325|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385326|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385327|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385328|NCT00446563|E2|Reported Event|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385329|NCT00446563|E1|Reported Event|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
385330|NCT00446641|B3|Baseline|Total|Total of all reporting groups
385331|NCT00446641|B2|Baseline|Placebo|matching placebo to cilostazol
385332|NCT00446641|B1|Baseline|Cilostazol|Cilostazol 100mg twice per day
385333|NCT00446641|P2|Participant Flow|Placebo|matching placebo to cilostazol
385334|NCT00446641|P1|Participant Flow|Cilostazol|Cilostazol 100mg twice per day
385335|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
385336|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
385337|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
385338|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
385339|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
385340|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
385341|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
385342|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
385343|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
385344|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
385345|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
385346|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
385347|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
385348|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
385349|NCT00446641|E2|Reported Event|Placebo|matching placebo to cilostazol
385350|NCT00446641|E1|Reported Event|Cilostazol|Cilostazol 100mg twice per day
385351|NCT00446654|B3|Baseline|Total|Total of all reporting groups
385352|NCT00446654|B2|Baseline|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
385353|NCT00446654|B1|Baseline|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
385354|NCT00446654|P2|Participant Flow|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
385355|NCT00446654|P1|Participant Flow|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
385356|NCT00446654|O2|Outcome|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
385357|NCT00446654|O1|Outcome|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
385358|NCT00446654|E2|Reported Event|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
385359|NCT00446654|E1|Reported Event|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
385360|NCT00446797|B3|Baseline|Total|Total of all reporting groups
385361|NCT00446797|B2|Baseline|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385362|NCT00446797|B1|Baseline|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385363|NCT00446797|P2|Participant Flow|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385364|NCT00446797|P1|Participant Flow|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385365|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385366|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385367|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385368|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385369|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385464|NCT00438360|E1|Reported Event|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
385370|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385371|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385372|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385373|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385374|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385375|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385376|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385377|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385378|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385379|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385380|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385381|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385382|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385383|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385384|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385385|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385386|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385387|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385388|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385389|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385390|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385511|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
385391|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385392|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385393|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385394|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385395|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385396|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385397|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385398|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385399|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385400|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385401|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385402|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385403|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385404|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385405|NCT00446797|E2|Reported Event|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
385406|NCT00446797|E1|Reported Event|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
385407|NCT00437983|B3|Baseline|Total|Total of all reporting groups
385408|NCT00437983|B2|Baseline|Placebo|Cellulose tainted with fishy odor
385409|NCT00437983|B1|Baseline|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
385410|NCT00437983|P2|Participant Flow|Placebo|Cellulose tainted with fishy odor
385411|NCT00437983|P1|Participant Flow|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
385412|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
385413|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
385414|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
385415|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
385416|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
385417|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
385418|NCT00437983|E2|Reported Event|Placebo|Cellulose tainted with fishy odor
385419|NCT00437983|E1|Reported Event|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
385420|NCT00438100|B3|Baseline|Total|Total of all reporting groups
385421|NCT00438100|B2|Baseline|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
385422|NCT00438100|B1|Baseline|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
385423|NCT00438100|P2|Participant Flow|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
385424|NCT00438100|P1|Participant Flow|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
385425|NCT00438100|O2|Outcome|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
385426|NCT00438100|O1|Outcome|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
385427|NCT00438100|E2|Reported Event|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
385465|NCT00438399|B4|Baseline|Total|Total of all reporting groups
385428|NCT00438100|E1|Reported Event|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
385429|NCT00438191|B3|Baseline|Total|Total of all reporting groups
385430|NCT00438191|B2|Baseline|Full Time Splinting|Subjects who wear the splint as much as possible
385431|NCT00438191|B1|Baseline|As-Desired Splinting|Subjects who wear the splint as desired
385432|NCT00438191|P2|Participant Flow|Full Time Splinting|Subjects who wear the splint as much as possible
385433|NCT00438191|P1|Participant Flow|As-Desired Splinting|Subjects who wear the splint as desired
385434|NCT00438191|O2|Outcome|Full Time Splinting|Subjects who wear the splint as much as possible
385435|NCT00438191|O1|Outcome|As-Desired Splinting|Subjects who wear the splint as desired
385436|NCT00438191|O2|Outcome|Full Time Splinting|Subjects who wear the splint as much as possible
385437|NCT00438191|O1|Outcome|As-Desired Splinting|Subjects who wear the splint as desired
385438|NCT00438191|O2|Outcome|Full Time Splinting|Subjects who wear the splint as much as possible
385439|NCT00438191|O1|Outcome|As-Desired Splinting|Subjects who wear the splint as desired
385440|NCT00438191|O2|Outcome|Full Time Splinting|Subjects who wear the splint as much as possible
385441|NCT00438191|O1|Outcome|As-Desired Splinting|Subjects who wear the splint as desired
385442|NCT00438191|E2|Reported Event|Full Time Splinting|Subjects who wear the splint as much as possible
385443|NCT00438191|E1|Reported Event|As-Desired Splinting|Subjects who wear the splint as desired
385444|NCT00438204|B1|Baseline|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
385445|NCT00438204|P1|Participant Flow|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
385446|NCT00438204|O1|Outcome|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
385447|NCT00438204|E1|Reported Event|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
385448|NCT00438360|B3|Baseline|Total|Total of all reporting groups
385449|NCT00438360|B2|Baseline|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
385450|NCT00438360|B1|Baseline|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
385451|NCT00438360|P2|Participant Flow|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
385452|NCT00438360|P1|Participant Flow|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
385453|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
385454|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
385455|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
385456|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
385457|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
385458|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
385459|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
385512|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
385460|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
385461|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
385462|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
385463|NCT00438360|E2|Reported Event|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
385466|NCT00438399|B3|Baseline|C. Propionate Compared to Corticosteroid 3|C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily
385467|NCT00438399|B2|Baseline|C. Propionate Compared to Corticosteroid 2|C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily
385468|NCT00438399|B1|Baseline|C. Propionate Compared to Corticosteroid 1|C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily
385469|NCT00438399|P6|Participant Flow|Corticosteroid 3-Wash Out-C. Propionate|Corticosteroid 3 first, then Clobetasol propionate
385470|NCT00438399|P5|Participant Flow|C. Propionate -Wash Out-Corticosteroid 3|Clobetasol propionate shampoo first then Corticosteroid 3
385471|NCT00438399|P4|Participant Flow|Corticosteroid 2-Wash Out-C. Propionate|Corticosteroid 2 first, then Clobetasol propionate shampoo
385472|NCT00438399|P3|Participant Flow|C. Propionate-Wash Out-Corticosteroid 2|Clobetasol propionate Shampoo first, then Corticosteroid 2
385473|NCT00438399|P2|Participant Flow|Corticosteroid 1-Wash Out-C. Propionate|Corticosteroid 1 first then Clobetasol propionate Shampoo
385474|NCT00438399|P1|Participant Flow|C. Propionate-Wash Out-Corticosteroid 1|Clobetasol propionate Shampoo first, then Corticosteroid 1
385475|NCT00438399|O3|Outcome|C. Propionate Compared to Corticosteroid 3|C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily
385476|NCT00438399|O2|Outcome|C. Propionate Compared to Corticosteroid 2|C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily
385477|NCT00438399|O1|Outcome|C. Propionate Compared to Corticosteroid 1|C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily
385478|NCT00438399|E4|Reported Event|Clobetasol Propionate Shampoo|All subjects having used Clobetasol propionate shampoo
385479|NCT00438399|E3|Reported Event|Corticosteroid 3|All subjects having used Corticosteroid 3
385480|NCT00438399|E2|Reported Event|Corticosteroid 2|All subjects having used Corticosteroid 2
385481|NCT00438399|E1|Reported Event|Corticosteroid 1|All subjects having used Corticosteroid 1
385482|NCT00438451|B4|Baseline|Total|Total of all reporting groups
385483|NCT00438451|B3|Baseline|Lamotrigine|Lamotrigine 25mg
385484|NCT00438451|B2|Baseline|Carbamazepine|Carbamazepine 100mg
385485|NCT00438451|B1|Baseline|Levetiracetam|Levetiracetam 250mg
385486|NCT00438451|P3|Participant Flow|Lamotrigine|Lamotrigine 25mg: capsules, each containing one Lamotrigine 25mg tablet. During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed.
385487|NCT00438451|P2|Participant Flow|Carbamazepine|"Carbamazepine 100mg: capsules, each containing half of one Carbamazepine 200mg slow release tablet.
During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed."
385488|NCT00438451|P1|Participant Flow|Levetiracetam|"Levetiracetam 250mg: capsules, each containing one Levetiracetam 250mg film-coated tablet.
During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed."
385489|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
385490|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
385491|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
385492|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
385493|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
385494|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
385495|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
385496|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
385497|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
385498|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
385499|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
385500|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
385501|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
385502|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
385503|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
385504|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
385505|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
385506|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
385507|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
385508|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
385509|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
385510|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
385530|NCT00438464|B1|Baseline|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385531|NCT00438464|P2|Participant Flow|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385532|NCT00438464|P1|Participant Flow|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385533|NCT00438464|O2|Outcome|Within GG4, Placebo Arm|Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
385534|NCT00438464|O1|Outcome|Within GG3, Placebo Arm|Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
385535|NCT00438464|O2|Outcome|Within GG4, Finasteride Arm|Participants with GG4 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
385536|NCT00438464|O1|Outcome|Within GG3, Finasteride Arm|Participants with GG3 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
442803|NCT00594425|O3|Outcome|Vehicle PDT|
385537|NCT00438464|O2|Outcome|GG4, Within Placebo Arm|Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
385538|NCT00438464|O1|Outcome|GG3, Within Placebo Arm|Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
385539|NCT00438464|O2|Outcome|GG4, Within Finasteride Arm|Participants with GG4 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
385540|NCT00438464|O1|Outcome|GG3, Within Finasteride Arm|Participants with GG3 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
385541|NCT00438464|O2|Outcome|Placebo Arm Within GG4|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385542|NCT00438464|O1|Outcome|Finasteride Arm Within GG4|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385543|NCT00438464|O2|Outcome|Placebo Arm Within GG3|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385544|NCT00438464|O1|Outcome|Finasteride Arm Within GG3|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385545|NCT00438464|O2|Outcome|Placebo Arm Within GG4|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385546|NCT00438464|O1|Outcome|Finasteride Arm Within GG4|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385547|NCT00438464|O2|Outcome|Placebo Arm Within GG3|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385548|NCT00438464|O1|Outcome|Finasteride Arm Within GG3|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385549|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385550|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385551|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385552|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385553|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385554|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385555|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385556|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385557|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385558|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385559|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385560|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385561|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385562|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385563|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385564|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385565|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385566|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385567|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385568|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385569|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385570|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385571|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385572|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385573|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385574|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385575|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385576|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385577|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385578|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385579|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385580|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385581|NCT00438464|E2|Reported Event|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
385582|NCT00438464|E1|Reported Event|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
385584|NCT00438490|B2|Baseline|Recombinant Human Prolactin|"RhProlactin once daily
Recombinant Human Prolactin :"
385585|NCT00438490|B1|Baseline|Placebo|
385586|NCT00438490|P2|Participant Flow|Recombinant Human Prolactin|Recombinant Human Prolactin 60 mcg/kg once daily
385587|NCT00438490|P1|Participant Flow|Placebo|Normal Saline Placebo once daily
385588|NCT00438490|O2|Outcome|Recombinant Human Prolactin|"RhProlactin once daily
Recombinant Human Prolactin :"
385589|NCT00438490|O1|Outcome|Placebo|
385590|NCT00438490|E2|Reported Event|Recombinant Human Prolactin|"RhProlactin once daily
Recombinant Human Prolactin :"
385591|NCT00438490|E1|Reported Event|Placebo|
385592|NCT00438659|B3|Baseline|Total|Total of all reporting groups
385593|NCT00438659|B2|Baseline|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
385714|NCT00447057|B5|Baseline|Total|Total of all reporting groups
385594|NCT00438659|B1|Baseline|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385595|NCT00438659|P2|Participant Flow|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
385596|NCT00438659|P1|Participant Flow|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385597|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
385598|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385599|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
385600|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385601|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
385602|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385603|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
385604|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385605|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
385606|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385607|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
385608|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385609|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
385610|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385611|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
385612|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385613|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
385614|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385615|NCT00438659|E2|Reported Event|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
385616|NCT00438659|E1|Reported Event|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
385617|NCT00438672|B3|Baseline|Total|Total of all reporting groups
385618|NCT00438672|B2|Baseline|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
385619|NCT00438672|B1|Baseline|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
385620|NCT00438672|P2|Participant Flow|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
385621|NCT00438672|P1|Participant Flow|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
385622|NCT00438672|O2|Outcome|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
385623|NCT00438672|O1|Outcome|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
385624|NCT00438672|O2|Outcome|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
385625|NCT00438672|O1|Outcome|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
385626|NCT00438672|E2|Reported Event|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
385627|NCT00438672|E1|Reported Event|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
385628|NCT00438750|B3|Baseline|Total|Total of all reporting groups
385629|NCT00438750|B2|Baseline|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
385630|NCT00438750|B1|Baseline|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
385631|NCT00438750|P2|Participant Flow|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
385632|NCT00438750|P1|Participant Flow|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
385633|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
385634|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
385635|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
385636|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
385637|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
385638|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
385639|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
385640|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
385641|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
385642|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
385643|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
385644|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
385645|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
385646|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
385647|NCT00438750|E2|Reported Event|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
385648|NCT00438750|E1|Reported Event|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
385649|NCT00438815|B1|Baseline|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
385650|NCT00438815|P1|Participant Flow|Open-label C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
385651|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
385652|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
385653|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
385654|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
385655|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
385656|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
385657|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
385658|NCT00438815|E1|Reported Event|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
385659|NCT00438854|B1|Baseline|Group 1|
385660|NCT00438854|P1|Participant Flow|Group 1|
385661|NCT00438854|O1|Outcome|Dasatinib|Treatment arm/dasatinib pill
385662|NCT00438854|E1|Reported Event|Group 1|
385663|NCT00438880|B3|Baseline|Total|Total of all reporting groups
385664|NCT00438880|B2|Baseline|Phase II|"Phase II patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385665|NCT00438880|B1|Baseline|Phase I|"Phase I patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1
10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385666|NCT00438880|P2|Participant Flow|Phase II|"Phase II patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385667|NCT00438880|P1|Participant Flow|Phase I|"Phase I patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1
10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385743|NCT00447590|B1|Baseline|LAP-BAND|All subjects who received the LAP-BAND System.
385668|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385669|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1
10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385861|NCT00448123|O2|Outcome|Tamsulosin|"Intervention - Tamsulosin
Tamsulosin: Study Drug"
385670|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385671|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1
10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385672|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385673|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1
10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385674|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385675|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1
10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385676|NCT00438880|E2|Reported Event|Phase II|"Phase II patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385677|NCT00438880|E1|Reported Event|Phase I|"Phase I patients will receive the following treatment:
250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1
10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
385678|NCT00446849|B1|Baseline|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase. A total of 208 subjects entered the maintenance phase (152 whose UC was quiescent at screening + 56 whose UC was quiescent after the acute phase).
385679|NCT00446849|P1|Participant Flow|Multi-Matrix System (MMX) Mesalamine|Subjects whose ulcerative colitis (UC) was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed orally once-daily [QD] at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
385680|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
385681|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
385682|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
385744|NCT00447590|P1|Participant Flow|LAP-BAND|All subjects who received the LAP-BAND System.
385745|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
385746|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
385683|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
385684|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
385685|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
385686|NCT00446849|E2|Reported Event|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
385687|NCT00446849|E1|Reported Event|MMX Mesalamine (Acute Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day).
385688|NCT00446992|B1|Baseline|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385689|NCT00446992|P1|Participant Flow|Antipsychotic-Naive Patients|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385690|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385691|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385692|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385693|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385694|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385695|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385696|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385697|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385698|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385699|NCT00446992|E1|Reported Event|Open Follow Up Group|"The patients were newly diagnosed with psychosis and this is their first exposure to an antipsychotic.
Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
385747|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
385748|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
385749|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
385700|NCT00447005|B1|Baseline|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385715|NCT00447057|B4|Baseline|Pemetrexed + Erlotinib (Squamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle"
385862|NCT00448123|O1|Outcome|Placebo|"Placebo
Placebo: Placebo"
385701|NCT00447005|P1|Participant Flow|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385702|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385703|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385704|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385705|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385706|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385707|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385708|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385709|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385710|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385711|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385712|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385750|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
385751|NCT00447590|E1|Reported Event|LAP-BAND|All subjects who received the LAP-BAND System.
385752|NCT00447603|B1|Baseline|All Enrolled|Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
385713|NCT00447005|E1|Reported Event|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.
Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
385716|NCT00447057|B3|Baseline|Pemetrexed (Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
385717|NCT00447057|B2|Baseline|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
385718|NCT00447057|B1|Baseline|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
385719|NCT00447057|P4|Participant Flow|Pemetrexed + Erlotinib (Squamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle"
385720|NCT00447057|P3|Participant Flow|Pemetrexed (Squamous)|Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
385721|NCT00447057|P2|Participant Flow|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle"
385722|NCT00447057|P1|Participant Flow|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression or unacceptable toxicity
385723|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous and Squamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
385724|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous and Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
385725|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
385726|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
385727|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
385728|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
385729|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
385730|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
385731|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
385732|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
385733|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
385734|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
385735|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
385736|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
385737|NCT00447057|E2|Reported Event|Pemetrexed + Erlotinib (Nonsquamous and Squamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
385738|NCT00447057|E1|Reported Event|Pemetrexed (Nonsquamous and Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
385739|NCT00447122|B1|Baseline|Treatment|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
385740|NCT00447122|P1|Participant Flow|Lapatinib and Gemcitabine|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
385741|NCT00447122|O1|Outcome|Lapatinib and Gemcitabine|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
385742|NCT00447122|E1|Reported Event|Treatment|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
385753|NCT00447603|P3|Participant Flow|Losartan 50 Mg-100 mg (Filter Period)|Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
385754|NCT00447603|P2|Participant Flow|Losartan 25 Mg-50 mg (Filter Period)|Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks
385755|NCT00447603|P1|Participant Flow|All Enrolled|Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
385756|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
385863|NCT00448123|O2|Outcome|Tamsulosin|Tamsulosin orally 0.4 mg/daily for up to 10 days.
385757|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
385758|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
385759|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
385760|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
385761|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
385762|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
385763|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
385764|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
385765|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
385766|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
385767|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
385768|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
385769|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
385770|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
385771|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
385772|NCT00447603|E2|Reported Event|Losartan 50 Mg-100 mg (Filter Period)|Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
385773|NCT00447603|E1|Reported Event|Losartan 25 Mg-50 mg (Filter Period)|Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks
385774|NCT00447876|B3|Baseline|Total Title|
385775|NCT00447876|B2|Baseline|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385776|NCT00447876|B1|Baseline|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385777|NCT00447876|P2|Participant Flow|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385778|NCT00447876|P1|Participant Flow|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385779|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385817|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385780|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385820|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
442804|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
385781|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385782|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385783|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385784|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385785|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385786|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385787|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385788|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385789|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385790|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385791|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385792|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385793|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385794|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385816|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385795|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385796|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385797|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385798|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385799|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385800|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385801|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385802|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385803|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385804|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385805|NCT00447876|E2|Reported Event|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385806|NCT00447876|E1|Reported Event|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
385807|NCT00447902|B3|Baseline|Total|Total of all reporting groups
385808|NCT00447902|B2|Baseline|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385809|NCT00447902|B1|Baseline|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385810|NCT00447902|P2|Participant Flow|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385811|NCT00447902|P1|Participant Flow|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385812|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385813|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385814|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385815|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385818|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385819|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385821|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385822|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385823|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385824|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385825|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385826|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385827|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385828|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385829|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385830|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385831|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385832|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385833|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385834|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385835|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385836|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385837|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385838|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385839|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385840|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385841|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385842|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385843|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385844|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385845|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385846|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385847|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385848|NCT00447902|E2|Reported Event|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
385849|NCT00447902|E1|Reported Event|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
385850|NCT00448019|B1|Baseline|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
385851|NCT00448019|P1|Participant Flow|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
385852|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
385853|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
385854|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
385855|NCT00448019|E1|Reported Event|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
385856|NCT00448123|B3|Baseline|Total|Total of all reporting groups
385857|NCT00448123|B2|Baseline|Tamsulosin|"Intervention - Tamsulosin
Tamsulosin: Study Drug"
385864|NCT00448123|O1|Outcome|Placebo|Active placebo orally per day for up to 10 days.
385865|NCT00448123|O2|Outcome|Tamsulosin|"Intervention - Tamsulosin
Tamsulosin: Study Drug"
385866|NCT00448123|O1|Outcome|Placebo|Placebo Group
385867|NCT00448123|E2|Reported Event|Tamsulosin|"Intervention - Tamsulosin
Tamsulosin: Study Drug"
385868|NCT00448123|E1|Reported Event|Placebo|Placebo Group
385869|NCT00448136|B3|Baseline|Total|Total of all reporting groups
385870|NCT00448136|B2|Baseline|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385871|NCT00448136|B1|Baseline|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385872|NCT00448136|P2|Participant Flow|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, orally (PO), twice daily (BID) on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385873|NCT00448136|P1|Participant Flow|Bevacizumab + 5-fluorouracil (5-FU) + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 22; 5-FU 400 mg per square meter per day (mg/m^2/day) IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385874|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385875|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385876|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385877|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385878|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385879|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385880|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385881|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385882|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385883|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385884|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385885|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385934|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385886|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385887|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385888|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385889|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
442805|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
385890|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385891|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385892|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385893|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385894|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385895|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385896|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385897|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385898|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385899|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385900|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385901|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385902|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385903|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385904|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385905|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385906|NCT00448136|E2|Reported Event|Bevacizumab + Capecitabine|Cycles 1-9 (21-Day cycle): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 2000 mg/m^2 tablets PO in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
385907|NCT00448136|E1|Reported Event|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
385908|NCT00448175|B3|Baseline|Total|Total of all reporting groups
385909|NCT00448175|B2|Baseline|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
399604|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
385910|NCT00448175|B1|Baseline|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
385911|NCT00448175|P2|Participant Flow|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
385912|NCT00448175|P1|Participant Flow|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
385913|NCT00448175|O2|Outcome|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
385938|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385914|NCT00448175|O1|Outcome|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
385915|NCT00448175|E2|Reported Event|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
385916|NCT00448175|E1|Reported Event|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
385917|NCT00448201|B1|Baseline|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
385918|NCT00448201|P1|Participant Flow|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
385919|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
385920|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
385921|NCT00448201|O2|Outcome|Day 90|90 days post-transplant
385922|NCT00448201|O1|Outcome|Day 60|60 days post-transplant
385923|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
385924|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
385925|NCT00448201|E1|Reported Event|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
385926|NCT00448227|B1|Baseline|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385927|NCT00448227|P1|Participant Flow|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385928|NCT00448227|O4|Outcome|Total|
385929|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385930|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385931|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385932|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385933|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
399605|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
385935|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385936|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385937|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
386014|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
385939|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385940|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385941|NCT00448227|O4|Outcome|Total|
385942|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385943|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385944|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385945|NCT00448227|O4|Outcome|Total|
385946|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385947|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385948|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385949|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385950|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385951|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385952|NCT00448227|E1|Reported Event|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
385953|NCT00448279|B3|Baseline|Total|Total of all reporting groups
385954|NCT00448279|B2|Baseline|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
385955|NCT00448279|B1|Baseline|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
385956|NCT00448279|P2|Participant Flow|Chemotherapy Plus (+) Trastuzumab|Participants received trastuzumab at either 2 milligrams per kilogram (mg/kg), intravenously (IV), every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
385957|NCT00448279|P1|Participant Flow|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
385958|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
385959|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
386211|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
385960|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
385961|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
442806|NCT00594425|O3|Outcome|Vehicle PDT|
385962|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
385963|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
385964|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
385965|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
385966|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
385967|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
385968|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
385969|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
385970|NCT00448279|E2|Reported Event|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
385971|NCT00448279|E1|Reported Event|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
385972|NCT00448344|B3|Baseline|Total|Total of all reporting groups
385973|NCT00448344|B2|Baseline|Arm 2|"Standard smoking cessation
Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
385974|NCT00448344|B1|Baseline|Arm 1|"Family-supported smoking cessation
Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
385975|NCT00448344|P2|Participant Flow|Standard Smoking Cessation|"Standard smoking cessation
Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
385976|NCT00448344|P1|Participant Flow|Family-supported Smoking Cessation|"Family-supported smoking cessation
Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
385977|NCT00448344|O2|Outcome|Arm 2|"Standard smoking cessation
Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
385978|NCT00448344|O1|Outcome|Arm 1|"Family-supported smoking cessation
Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
385979|NCT00448344|O2|Outcome|Arm 2|"Standard smoking cessation
Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
385980|NCT00448344|O1|Outcome|Arm 1|"Family-supported smoking cessation
Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
385981|NCT00448344|E2|Reported Event|Arm 2|"Standard smoking cessation
Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
386015|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
385982|NCT00448344|E1|Reported Event|Arm 1|"Family-supported smoking cessation
Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
385983|NCT00448357|B1|Baseline|Experimental: GVHD Prophylaxis|"Experimental: GVHD prophylaxis
Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine .
Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
385984|NCT00448357|P1|Participant Flow|Experimental: GVHD Prophylaxis|"Experimental: GVHD prophylaxis
Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine .
Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
385985|NCT00448357|O3|Outcome|High Busulfan AUC Tertile (7605)|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
385986|NCT00448357|O2|Outcome|Intermediate Busulfan AUC Tertile (6372)|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
385987|NCT00448357|O1|Outcome|Low Busulfan AUC Tertile (5078)|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
385988|NCT00448357|O1|Outcome|Experimental: GVHD Prophylaxis|"Matched related donor (MRD) subjects receive Graft Vs Host Disease (GVHD )prophylaxis with Methotrexate alone Subjects also receive busulfan, fludarabine, and tacrolimus and may receive Alemtuzumab.
Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
385989|NCT00448357|O3|Outcome|High Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
385990|NCT00448357|O2|Outcome|Intermediate Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
385991|NCT00448357|O1|Outcome|Low Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
385992|NCT00448357|O5|Outcome|Dose Level 5|Target AUC/24 hrs of 8363 uM-min+/- 15%
385993|NCT00448357|O4|Outcome|Dose Level 4|Target AUC/24 hrs of 7603 uM-min+/- 15%
385994|NCT00448357|O3|Outcome|Dose Level 3|Target AUC/24 hrs of 6912 uM-min +/- 15%
385995|NCT00448357|O2|Outcome|Dose Level 2|Target AUC/24 hrs of 5760 uM-min +/- 15%
385996|NCT00448357|O1|Outcome|Dose Level 1|Target AUC/24 hrs of 4800 uM-min +/-15%
385997|NCT00448357|O5|Outcome|Dose Level 5|Target AUC/24 hrs of 8363 uM-min+/- 15%
385998|NCT00448357|O4|Outcome|Dose Level 4|Target AUC/24 hrs of 7603 uM-min+/- 15%
385999|NCT00448357|O3|Outcome|Dose Level 3|Target AUC/24 hrs of 6912 uM-min +/- 15%
386000|NCT00448357|O2|Outcome|Dose Level 2|Target AUC/24 hrs of 5760 uM-min +/- 15%
386001|NCT00448357|O1|Outcome|Dose Level 1|Target AUC/24 hrs of 4800 micrometer (uM)-min +/-15%
386002|NCT00448357|O3|Outcome|High Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
386003|NCT00448357|O2|Outcome|Intermediate Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
386004|NCT00448357|O1|Outcome|Low Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
386005|NCT00448357|E1|Reported Event|Experimental: GVHD Prophylaxis|"Experimental: GVHD prophylaxis
Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine .
Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
386006|NCT00448435|B1|Baseline|Overall Study Population|Randomized Population
386007|NCT00448435|P2|Participant Flow|SLM 50 Mcg + FP 100 Mcg/Day First|SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in first intervention period and GW815SF (SFC; Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in second intervention period (after washout period).
386008|NCT00448435|P1|Participant Flow|SFC 50/100 Mcg/Day First|GW815SF (SFC; Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in first intervention period and SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in second intervention period (after washout period).
386009|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
386010|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
400374|NCT00487279|B2|Baseline|Control Group|Medical therapy alone
386011|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
386012|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
386013|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
386016|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
386017|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
386018|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
386019|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
386020|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
386021|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
386022|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
386023|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
386024|NCT00448435|O2|Outcome|SLM 50mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily
386025|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
386026|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
386027|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
386028|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
386029|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
386030|NCT00448435|E3|Reported Event|SFC 50/100mcg/Day (Extension Period)|Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period
386031|NCT00448435|E2|Reported Event|SLM 50 + FP 100 Mcg/Day|Safety Population who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
386032|NCT00448435|E1|Reported Event|SFC 50/100 Mcg/Day|Safety Population who received GW815SF (SFC, Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
386033|NCT00448448|B3|Baseline|Total|Total of all reporting groups
386034|NCT00448448|B2|Baseline|Observation|Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
386035|NCT00448448|B1|Baseline|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
Brace: Brace (TLSO) prescribed for at least 18 hours per day. Wear time measured using a temperature monitor. Orthotic evaluations are conducted every 6 months and as necessary to maintain brace fit and function."
386036|NCT00448448|P2|Participant Flow|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
Observation: Clinical, radiographic, and self-report follow-up every 6 months."
386037|NCT00448448|P1|Participant Flow|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.
Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
386038|NCT00448448|O2|Outcome|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
Observation: Clinical, radiographic, and self-report follow-up every 6 months."
386039|NCT00448448|O1|Outcome|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.
Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
386040|NCT00448448|E2|Reported Event|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
Observation: Clinical, radiographic, and self-report follow-up every 6 months."
386041|NCT00448448|E1|Reported Event|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.
Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
386042|NCT00448539|B3|Baseline|Total|Total of all reporting groups
386084|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
386362|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
442807|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
386043|NCT00448539|B2|Baseline|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
386044|NCT00448539|B1|Baseline|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
386045|NCT00448539|P2|Participant Flow|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study,during the 12-18 day open-label Titration Phase, subjects receiving 2400-3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400-3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
386046|NCT00448539|P1|Participant Flow|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400-3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400-3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
386047|NCT00448539|O2|Outcome|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
386048|NCT00448539|O1|Outcome|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
386049|NCT00448539|E2|Reported Event|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study,during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
386083|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
386355|NCT00449540|B2|Baseline|Sham TMS Device|Simulated Sham treatment without TMS
386356|NCT00449540|B1|Baseline|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
386085|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
386363|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
386050|NCT00448539|E1|Reported Event|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
386051|NCT00448591|B1|Baseline|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
386052|NCT00448591|P1|Participant Flow|Bevacizumab|Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy or in combination with other chemotherapy as prescribed.
386053|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
386054|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
386055|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
386056|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
386057|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
386058|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
386059|NCT00448591|E1|Reported Event|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
386060|NCT00448630|B1|Baseline|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
386061|NCT00448630|P1|Participant Flow|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
386062|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
386063|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
386064|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
386065|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
386066|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
386067|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
386068|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
386069|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
386070|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
386071|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
386072|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
386073|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
386074|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
386075|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
386076|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
386077|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
386078|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
386079|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
386080|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
386081|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
386082|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
386178|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
400523|NCT00487942|B5|Baseline|Total|Total of all reporting groups
386086|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
386087|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
386088|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
386089|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
386090|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
386091|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
386092|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
386093|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
386094|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
386095|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
386096|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
386097|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
386098|NCT00448630|E7|Reported Event|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
386099|NCT00448630|E6|Reported Event|Amisulpride|amisulpride as prescribed by subject's physician
386100|NCT00448630|E5|Reported Event|Aripiprazole|aripiprazole as prescribed by subject's physician
386101|NCT00448630|E4|Reported Event|Olanzipine|olanzipine as prescribed by subject's physician
386102|NCT00448630|E3|Reported Event|Quetiapine|quetiapine as prescribed by subject's physician
386103|NCT00448630|E2|Reported Event|Risperidone|risperidone as prescribed by subject's physician
386104|NCT00448630|E1|Reported Event|Ziprasidone|ziprasidone as prescribed by subject's physician
386105|NCT00448682|B1|Baseline|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:
Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.
Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).
There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
386106|NCT00448682|P1|Participant Flow|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:
Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.
Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).
There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
386107|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:
Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.
Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).
There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
386108|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:
Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.
Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).
There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
400981|NCT00488319|B4|Baseline|Total|Total of all reporting groups
386109|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:
Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.
Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).
There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
386364|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
386110|NCT00448682|E1|Reported Event|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:
Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.
Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).
There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
386111|NCT00448708|B3|Baseline|Total|Total of all reporting groups
386112|NCT00448708|B2|Baseline|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
386113|NCT00448708|B1|Baseline|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
386114|NCT00448708|P2|Participant Flow|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
386115|NCT00448708|P1|Participant Flow|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
386116|NCT00448708|O2|Outcome|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
386117|NCT00448708|O1|Outcome|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
386118|NCT00448708|O2|Outcome|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
386119|NCT00448708|O1|Outcome|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
386120|NCT00448708|E2|Reported Event|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
386121|NCT00448708|E1|Reported Event|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
386122|NCT00448760|B1|Baseline|Single Arm|5-Fluorodeoxyuridine, Leucovorin, Oxaliplatin and Docetaxel
386123|NCT00448760|P1|Participant Flow|Neoadjuvant + Adjuvant Chemotherapy|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
386124|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
386125|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
386126|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
386127|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
386128|NCT00448760|E1|Reported Event|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
Conventional surgery : Surgical removal of tumor for correlative studies
reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy
Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
Microarray analysis : Analysis of tumor for pathologic response to protocol therapy
Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
386129|NCT00448864|B4|Baseline|Total|Total of all reporting groups
386130|NCT00448864|B3|Baseline|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
386131|NCT00448864|B2|Baseline|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
386357|NCT00449540|P3|Participant Flow|Sham TMS Device|Device which does not deliver TMS pulse
386132|NCT00448864|B1|Baseline|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
386181|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386133|NCT00448864|P3|Participant Flow|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
386134|NCT00448864|P2|Participant Flow|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
386135|NCT00448864|P1|Participant Flow|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours.
386136|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
386137|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
386138|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
386139|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
386140|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
386141|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
386142|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
386143|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
386144|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
386145|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
386146|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. Intravenous (IV) infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
386147|NCT00448864|E3|Reported Event|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
386148|NCT00448864|E2|Reported Event|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
386358|NCT00449540|P2|Participant Flow|Active TMS|Active Transcranial Magnetic Stimulation Device
386180|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386486|NCT00441974|O1|Outcome|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
386149|NCT00448864|E1|Reported Event|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
386150|NCT00448916|B5|Baseline|Total|Total of all reporting groups
386151|NCT00448916|B4|Baseline|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386152|NCT00448916|B3|Baseline|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386153|NCT00448916|B2|Baseline|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386154|NCT00448916|B1|Baseline|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386155|NCT00448916|P4|Participant Flow|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386156|NCT00448916|P3|Participant Flow|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386157|NCT00448916|P2|Participant Flow|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386158|NCT00448916|P1|Participant Flow|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386159|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386160|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386161|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386162|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386163|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386164|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386165|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386166|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386167|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386168|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386169|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386170|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386171|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386172|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386173|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386174|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386175|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386176|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386177|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386179|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386182|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386183|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386184|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386185|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386186|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386187|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386188|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386189|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386190|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386191|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386192|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386193|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386194|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386195|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386196|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386197|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386198|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386199|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386200|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386201|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386202|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386203|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386204|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386205|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386206|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386207|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
386208|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386209|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386210|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386440|NCT00449865|B2|Baseline|Creatine|creatine 5 grams twice daily
386441|NCT00449865|B1|Baseline|Placebo|placebo: an inactive substance
386212|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386213|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386214|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386215|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386216|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386217|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386218|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386219|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386220|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386221|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386222|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386223|NCT00448916|E5|Reported Event|Overall|This arm summarizes the AE data from all the treatment groups.
386224|NCT00448916|E4|Reported Event|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386225|NCT00448916|E3|Reported Event|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
386226|NCT00448916|E2|Reported Event|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
386227|NCT00448916|E1|Reported Event|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
386228|NCT00449033|B3|Baseline|Total|Total of all reporting groups
386229|NCT00449033|B2|Baseline|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386230|NCT00449033|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386231|NCT00449033|P2|Participant Flow|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386232|NCT00449033|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386233|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386234|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386235|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386236|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386237|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386238|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386239|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386240|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386241|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386242|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386243|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386244|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386245|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386246|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386247|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386442|NCT00449865|P2|Participant Flow|Creatine|creatine monohydrate (10 gram /day)
386248|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386249|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386250|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386251|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386252|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386253|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386254|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386255|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386256|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386257|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386258|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386259|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386260|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
406280|NCT00502593|B13|Baseline|Total|Total of all reporting groups
386261|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
442808|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
386262|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386263|NCT00449033|E2|Reported Event|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
386264|NCT00449033|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
386265|NCT00449046|B1|Baseline|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
386266|NCT00449046|P1|Participant Flow|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
386267|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
386268|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
386269|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
386270|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
386271|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
386272|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
386273|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
386274|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
386275|NCT00449046|E1|Reported Event|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
386276|NCT00449072|B3|Baseline|Total|Total of all reporting groups
386277|NCT00449072|B2|Baseline|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication"
386278|NCT00449072|B1|Baseline|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication"
386279|NCT00449072|P2|Participant Flow|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication"
386280|NCT00449072|P1|Participant Flow|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication"
386281|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386282|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386283|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386284|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386443|NCT00449865|P1|Participant Flow|Placebo|placebo: an inactive substance
386285|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386359|NCT00449540|P1|Participant Flow|30 Day Lead in Phase|some particpants did not experience migrain in the 30 days allotted and therefore were not moved to the treatment phase
386286|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386287|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386288|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386289|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386290|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386291|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386292|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386293|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386294|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386295|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386296|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386297|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386298|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386299|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386300|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication."
386301|NCT00449072|E2|Reported Event|TAA-AQ|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
TAA-AQ in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication"
386302|NCT00449072|E1|Reported Event|Placebo|"3 to 9 year old participants with PAR administered
Placebo (once to demonstrate IP administration in the baseline/screening period)
Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication"
386303|NCT00449150|B4|Baseline|Total|Total of all reporting groups
386304|NCT00449150|B3|Baseline|Placebo|Placebo on Week 0, 2 26 and 28
386305|NCT00449150|B2|Baseline|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
386306|NCT00449150|B1|Baseline|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
386307|NCT00449150|P3|Participant Flow|Placebo|Placebo on Week 0, 2 26 and 28
386308|NCT00449150|P2|Participant Flow|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
386309|NCT00449150|P1|Participant Flow|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
386310|NCT00449150|O3|Outcome|Placebo|Placebo on Week 0, 2 26 and 28
386311|NCT00449150|O2|Outcome|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
386312|NCT00449150|O1|Outcome|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
386313|NCT00449150|E3|Reported Event|Placebo|Placebo on Week 0, 2 26 and 28
386314|NCT00449150|E2|Reported Event|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
386315|NCT00449150|E1|Reported Event|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
386444|NCT00449865|O2|Outcome|Creatine|creatine monohydrate (10 grams/day)
386360|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
386361|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
442809|NCT00594425|O3|Outcome|Vehicle PDT|
386316|NCT00449163|B1|Baseline|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;
Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;
Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
386317|NCT00449163|P1|Participant Flow|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;
Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;
Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
386318|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;
Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;
Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
386319|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;
Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;
Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
386320|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;
Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;
Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
386321|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;
Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;
Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
386322|NCT00449163|E1|Reported Event|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;
Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;
Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
386323|NCT00449176|B4|Baseline|Total|Total of all reporting groups
386324|NCT00449176|B3|Baseline|Placebo|Matching Placebo twice daily(BID)
386325|NCT00449176|B2|Baseline|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
386326|NCT00449176|B1|Baseline|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
386327|NCT00449176|P3|Participant Flow|Placebo|Matching Placebo twice daily(BID)
386328|NCT00449176|P2|Participant Flow|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
386329|NCT00449176|P1|Participant Flow|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
386330|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
386331|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
386332|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
386333|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
386334|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
386335|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
386336|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
386337|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
386338|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
386339|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
386340|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
386341|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
386342|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
386343|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
386344|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
386345|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
386346|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
386347|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
386348|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
386349|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
386350|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
386351|NCT00449176|E3|Reported Event|Placebo|Matching Placebo twice daily(BID)
386352|NCT00449176|E2|Reported Event|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
386353|NCT00449176|E1|Reported Event|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
386354|NCT00449540|B3|Baseline|Total|Total of all reporting groups
386365|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
386366|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
386367|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
386368|NCT00449540|E4|Reported Event|Sham TMS Device - Not Treatment Related|Sham TMS Device - events that are not treatment related
386369|NCT00449540|E3|Reported Event|Active TMS - Not Treatment Related|Active Transcranial Magnetic Stimulation Device Treatment - Not treatment related
386370|NCT00449540|E2|Reported Event|Sham TMS Device - Treatment Related|Simulated Sham treatment without TMS
386371|NCT00449540|E1|Reported Event|Active TMS Device - Treatment Related|Active Transcranial Magnetic Stimulation Device Treatment - Treatment related
386372|NCT00449644|B5|Baseline|Total|Total of all reporting groups
386373|NCT00449644|B4|Baseline|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
386374|NCT00449644|B3|Baseline|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
386375|NCT00449644|B2|Baseline|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
386376|NCT00449644|B1|Baseline|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
386377|NCT00449644|P4|Participant Flow|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
386378|NCT00449644|P3|Participant Flow|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
386379|NCT00449644|P2|Participant Flow|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
386380|NCT00449644|P1|Participant Flow|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
386381|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
386382|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
386383|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week.
386384|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
386385|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
386386|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
386387|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
386388|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
386389|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
386390|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
386391|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
386392|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
386487|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
386488|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
386393|NCT00449644|E4|Reported Event|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
386394|NCT00449644|E3|Reported Event|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
386395|NCT00449644|E2|Reported Event|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
386396|NCT00449644|E1|Reported Event|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
386397|NCT00449696|B3|Baseline|Total|Total of all reporting groups
386398|NCT00449696|B2|Baseline|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386399|NCT00449696|B1|Baseline|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386400|NCT00449696|P2|Participant Flow|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386401|NCT00449696|P1|Participant Flow|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386402|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386403|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386404|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386405|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386406|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386407|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386408|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386409|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386410|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386411|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386412|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386413|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386414|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386415|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386416|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386417|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386418|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386419|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386420|NCT00449696|E2|Reported Event|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
386421|NCT00449696|E1|Reported Event|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
386422|NCT00449748|B1|Baseline|RAD001|Oral RAD001 10 mg daily for 30 days
386423|NCT00449748|P1|Participant Flow|RAD001|Oral RAD001 10 mg daily for 30 days
386424|NCT00449748|O1|Outcome|RAD001|Oral RAD001 10 mg daily for 30 days
386425|NCT00449748|E1|Reported Event|RAD001|Oral RAD001 10 mg daily for 30 days
386426|NCT00449787|B3|Baseline|Total|Total of all reporting groups
386427|NCT00449787|B2|Baseline|Naproxen|Naproxen 500 mg tablet
386428|NCT00449787|B1|Baseline|Sumatriptan|Sumatriptan 100 mg tablet
386429|NCT00449787|P2|Participant Flow|Naproxen|Naproxen 500 mg tablet
386430|NCT00449787|P1|Participant Flow|Sumatriptan|Sumatriptan 100 mg tablet
386431|NCT00449787|O2|Outcome|Naproxen|Naproxen 500 mg tablet
386432|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100 mg tablet
386433|NCT00449787|O2|Outcome|Naproxen|Naproxen 500mg tablet
386434|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100mg tablet
386435|NCT00449787|O2|Outcome|Naproxen|Naproxen 500mg tablet
386436|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100mg tablet
386437|NCT00449787|E2|Reported Event|Naproxen|Naproxen 500 mg tablet
386438|NCT00449787|E1|Reported Event|Sumatriptan|Sumatriptan 100 mg tablet
386439|NCT00449865|B3|Baseline|Total|Total of all reporting groups
386449|NCT00449930|B2|Baseline|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
386450|NCT00449930|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
386862|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386451|NCT00449930|P2|Participant Flow|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
386452|NCT00449930|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
386453|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
386454|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
386455|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
386456|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
386457|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
386458|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
386459|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
386460|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
386461|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
386462|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
386463|NCT00449930|E2|Reported Event|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
386464|NCT00449930|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
386465|NCT00449956|B4|Baseline|Total|Total of all reporting groups
386466|NCT00449956|B3|Baseline|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
386467|NCT00449956|B2|Baseline|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
386468|NCT00449956|B1|Baseline|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
386469|NCT00449956|P3|Participant Flow|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
386470|NCT00449956|P2|Participant Flow|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
386471|NCT00449956|P1|Participant Flow|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
386472|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
386473|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
386474|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
386475|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
386476|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
386477|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
386478|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
386479|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
386480|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
386481|NCT00449956|E3|Reported Event|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
386482|NCT00449956|E2|Reported Event|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
386483|NCT00449956|E1|Reported Event|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
386484|NCT00441974|B1|Baseline|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
386485|NCT00441974|P1|Participant Flow|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
386489|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
386490|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
386491|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
386492|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
386493|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
386494|NCT00441974|O3|Outcome|Total|Total of HBeAg+ and HBeAg- participants
386495|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
386496|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
386497|NCT00441974|E1|Reported Event|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
386498|NCT00442013|B3|Baseline|Total|Total of all reporting groups
386499|NCT00442013|B2|Baseline|Placebo Group|Matching placebo
386500|NCT00442013|B1|Baseline|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
386501|NCT00442013|P2|Participant Flow|Placebo Group|Matching placebo with no active ingredients. Either 1 or 2 tablets per day, depending on weight, in the evening before a meal
386502|NCT00442013|P1|Participant Flow|Lansoprazole Group|15 mg/day by mouth for children weighing less than 30kg, one tablet per day in the evening before a meal 30 mg/day by mouth for children weighing 30 kg or more, two tablets per day in the evening before a meal
386503|NCT00442013|O2|Outcome|Placebo Group|matching placebo
386504|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
386505|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
386506|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
386507|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
386508|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
386509|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
386510|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
386511|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
386512|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
386513|NCT00442013|O2|Outcome|Placebo Group|matching placebo
386514|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
386515|NCT00442013|E2|Reported Event|Placebo Group|Matching placebo
386516|NCT00442013|E1|Reported Event|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
386517|NCT00442117|B3|Baseline|Total|Total of all reporting groups
386518|NCT00442117|B2|Baseline|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
386519|NCT00442117|B1|Baseline|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
386520|NCT00442117|P2|Participant Flow|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
386521|NCT00442117|P1|Participant Flow|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
386522|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
386523|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
386524|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
386525|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
386526|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
386527|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
386528|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
386529|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
386530|NCT00442117|E2|Reported Event|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
386531|NCT00442117|E1|Reported Event|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
386532|NCT00442169|B7|Baseline|Total|Total of all reporting groups
386533|NCT00442169|B6|Baseline|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386605|NCT00442338|O1|Outcome|Montelukast 7 mg|Montelukast 7 mg IV Administration
386534|NCT00442169|B5|Baseline|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
386535|NCT00442169|B4|Baseline|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386536|NCT00442169|B3|Baseline|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386537|NCT00442169|B2|Baseline|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
386538|NCT00442169|B1|Baseline|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
386539|NCT00442169|P6|Participant Flow|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386540|NCT00442169|P5|Participant Flow|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
386541|NCT00442169|P4|Participant Flow|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386542|NCT00442169|P3|Participant Flow|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386543|NCT00442169|P2|Participant Flow|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
386544|NCT00442169|P1|Participant Flow|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
386545|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386546|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
386547|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386548|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386549|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
386550|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
386551|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386552|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
386553|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386554|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386555|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
386556|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
386557|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386558|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
386559|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386560|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386561|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
386562|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
386563|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386564|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
386565|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386566|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386567|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
386568|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
386569|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386570|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
386571|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386572|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386573|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
386574|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
386575|NCT00442169|E6|Reported Event|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386576|NCT00442169|E5|Reported Event|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
386577|NCT00442169|E4|Reported Event|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
386578|NCT00442169|E3|Reported Event|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
387071|NCT00443118|B1|Baseline|T-Piece|Subjects assigned to be resuscitated with T-Piece
386579|NCT00442169|E2|Reported Event|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
386580|NCT00442169|E1|Reported Event|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
386581|NCT00442286|B4|Baseline|Total|Total of all reporting groups
386582|NCT00442286|B3|Baseline|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
386583|NCT00442286|B2|Baseline|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
386584|NCT00442286|B1|Baseline|Roll-In|Subjects that were not included in endpoint analyses
386585|NCT00442286|P2|Participant Flow|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
386586|NCT00442286|P1|Participant Flow|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
386587|NCT00442286|O2|Outcome|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
386588|NCT00442286|O1|Outcome|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
386589|NCT00442286|O1|Outcome|All Implanted or Attempted Patients|All Implanted or Attempted patients active at 30 days post-implant. Excludes roll-in patients.
386590|NCT00442286|O1|Outcome|All Implanted or Attempted Patients|All Implanted or Attempted patients enrolled in the study. Roll-ins were excluded.
386591|NCT00442286|O1|Outcome|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
386592|NCT00442286|O2|Outcome|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
386593|NCT00442286|O1|Outcome|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
386594|NCT00442286|E2|Reported Event|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
386595|NCT00442286|E1|Reported Event|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
386596|NCT00442338|B4|Baseline|Total|Total of all reporting groups
386597|NCT00442338|B3|Baseline|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
386598|NCT00442338|B2|Baseline|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
386599|NCT00442338|B1|Baseline|Montelukast 7 mg|Montelukast 7 mg IV Administration
386600|NCT00442338|P3|Participant Flow|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
386601|NCT00442338|P2|Participant Flow|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
386602|NCT00442338|P1|Participant Flow|Montelukast 7 mg|Montelukast 7 mg IV Administration
386603|NCT00442338|O3|Outcome|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
386606|NCT00442338|E3|Reported Event|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
386607|NCT00442338|E2|Reported Event|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
386608|NCT00442338|E1|Reported Event|Montelukast 7 mg|Montelukast 7 mg IV Administration
386609|NCT00442351|B3|Baseline|Total|Total of all reporting groups
386610|NCT00442351|B2|Baseline|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
386611|NCT00442351|B1|Baseline|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
442810|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
386612|NCT00442351|P2|Participant Flow|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
386613|NCT00442351|P1|Participant Flow|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
386614|NCT00442351|O2|Outcome|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
386615|NCT00442351|O1|Outcome|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
386616|NCT00442351|E2|Reported Event|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
386617|NCT00442351|E1|Reported Event|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
386618|NCT00442364|B1|Baseline|Safety Evaluable|patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
386619|NCT00442364|P1|Participant Flow|Polidocanol 1% Injectable Microfoam|polidocanol injectable microfoam 1%
386620|NCT00442364|O1|Outcome|Safety Evaluable Population|polidocanol injectable foam 1% with circulating MCA bubbles present at MRI
386621|NCT00442364|E1|Reported Event|Safety Evaluable|patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
386622|NCT00442416|B3|Baseline|Total|Total of all reporting groups
386623|NCT00442416|B2|Baseline|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386624|NCT00442416|B1|Baseline|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386625|NCT00442416|P2|Participant Flow|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386626|NCT00442416|P1|Participant Flow|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386627|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386628|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386629|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386630|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386631|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386632|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386660|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
387067|NCT00443053|E1|Reported Event|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
386633|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386634|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386635|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386636|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386637|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386638|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386639|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386640|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386641|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386642|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386643|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386644|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386658|NCT00442468|B1|Baseline|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386659|NCT00442468|P1|Participant Flow|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
387426|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
386661|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
387068|NCT00443118|B4|Baseline|Total|Total of all reporting groups
386645|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386646|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386647|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386648|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386649|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386650|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386651|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386652|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386653|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386654|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386655|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386656|NCT00442416|E2|Reported Event|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
386657|NCT00442416|E1|Reported Event|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
386860|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386662|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386663|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386664|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386665|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386666|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386667|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386668|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386669|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386670|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386671|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386672|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386673|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386674|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386675|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386676|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386677|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386678|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386679|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386680|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386681|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386682|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386683|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386684|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386685|NCT00442468|E1|Reported Event|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
386686|NCT00442507|B1|Baseline|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
386687|NCT00442507|P1|Participant Flow|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
387140|NCT00443352|O1|Outcome|Duloxetine|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
386688|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
386689|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
386690|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
386691|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
386692|NCT00442507|E1|Reported Event|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
386693|NCT00442546|B4|Baseline|Total|Total of all reporting groups
386694|NCT00442546|B3|Baseline|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386695|NCT00442546|B2|Baseline|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386696|NCT00442546|B1|Baseline|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386697|NCT00442546|P3|Participant Flow|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386698|NCT00442546|P2|Participant Flow|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386699|NCT00442546|P1|Participant Flow|Pregabalin (150 Milligrams [mg])|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on Post-Operative Day 1 (POD 1).
386700|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386701|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386702|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386703|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386704|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386705|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386706|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386707|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386708|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386709|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386898|NCT00442611|B2|Baseline|IV Fluid|"The placebo arm will receive matched intravenous fluids.
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386710|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
387069|NCT00443118|B3|Baseline|Self Inflating Bag Without PEEP|Subjects allocated to Self Inflating Bag without PEEP
386711|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386712|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386713|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386714|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386715|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386716|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386717|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386718|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386719|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386720|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386721|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386722|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386723|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386724|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386725|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386726|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386727|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386728|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386729|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386730|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386731|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386732|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386733|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386734|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386735|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386736|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386737|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386738|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386739|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386740|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386741|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386742|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386743|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386744|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386745|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386746|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386747|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386748|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386749|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386750|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386751|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386752|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386753|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386754|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386755|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386756|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386757|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386758|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386759|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386760|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386761|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386762|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386763|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386764|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386765|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386766|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386767|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386768|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386769|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386770|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386771|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386772|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386773|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386774|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386775|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386776|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386777|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386778|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386779|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386780|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386781|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386782|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386783|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386784|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386785|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386786|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386787|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386788|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386789|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386790|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386791|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386792|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386793|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386794|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386795|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386796|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386797|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386798|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386799|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386800|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386801|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386802|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386803|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386804|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386805|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386806|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386807|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386808|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386809|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386810|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386811|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386812|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386813|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386814|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386815|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386816|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386817|NCT00442546|E3|Reported Event|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
386818|NCT00442546|E2|Reported Event|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386819|NCT00442546|E1|Reported Event|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
386820|NCT00442559|B3|Baseline|Total|Total of all reporting groups
386821|NCT00442559|B2|Baseline|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386822|NCT00442559|B1|Baseline|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386823|NCT00442559|P2|Participant Flow|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386824|NCT00442559|P1|Participant Flow|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386825|NCT00442559|O4|Outcome|Daily Allergic Rhinitis Symptom Score 12 Weeks - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386826|NCT00442559|O3|Outcome|Daily Allergic Rhinitis Symptom Score at Baseline - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386827|NCT00442559|O2|Outcome|Daily Allergic Rhinitis Symptom Score at 12 Weeks- Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386828|NCT00442559|O1|Outcome|Daily Allergic Rhinitis Symptom Score at Baseline- Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386829|NCT00442559|O4|Outcome|Daytime Asthma Symptom Score at 12 Weeks - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386830|NCT00442559|O3|Outcome|Daytime Asthma Symptom Score at Baseline - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
387058|NCT00443053|O2|Outcome|Placebo|Matching placebo
386861|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386831|NCT00442559|O2|Outcome|Daytime Asthma Symptom Score at 12 Weeks - Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386832|NCT00442559|O1|Outcome|Daytime Asthma Symptom Score at Baseline - Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386833|NCT00442559|E2|Reported Event|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386834|NCT00442559|E1|Reported Event|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
386835|NCT00442572|B3|Baseline|Total|Total of all reporting groups
386836|NCT00442572|B2|Baseline|No Intervention|Participants were on non- specific anti-viral treatment.
386837|NCT00442572|B1|Baseline|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386838|NCT00442572|P2|Participant Flow|No Intervention|Participants were on non- specific anti-viral treatment.
386839|NCT00442572|P1|Participant Flow|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a (PEGASYS®). Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms (µg) in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously (SC) and followed by 12 weeks period without treatment.
386840|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386841|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386842|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386843|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386844|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386845|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386846|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386847|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386848|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386849|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386850|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386851|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386852|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386853|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386854|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386855|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386856|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386857|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386858|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386859|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386863|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386864|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386865|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386866|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386867|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386868|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386869|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386870|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386871|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
386872|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
386873|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment..
386874|NCT00442572|E2|Reported Event|No Intervention|Participants were on non- specific anti-viral treatment.
386875|NCT00442572|E1|Reported Event|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.
386876|NCT00442598|B4|Baseline|Total|Total of all reporting groups
386877|NCT00442598|B3|Baseline|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386878|NCT00442598|B2|Baseline|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386879|NCT00442598|B1|Baseline|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide"
386880|NCT00442598|P3|Participant Flow|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386881|NCT00442598|P2|Participant Flow|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386882|NCT00442598|P1|Participant Flow|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide"
386883|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386884|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386885|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide"
386886|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386887|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386888|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide"
386889|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386890|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386891|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide"
386892|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386893|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386894|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide"
386895|NCT00442598|E2|Reported Event|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide"
386896|NCT00442598|E1|Reported Event|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide"
386897|NCT00442611|B3|Baseline|Total|Total of all reporting groups
387059|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
386899|NCT00442611|B1|Baseline|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.
Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386900|NCT00442611|P2|Participant Flow|IV Fluid|"The placebo arm will receive matched intravenous fluids.
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386901|NCT00442611|P1|Participant Flow|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.
Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386902|NCT00442611|O2|Outcome|IV Fluid|"The placebo arm will receive matched intravenous fluids.
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386903|NCT00442611|O1|Outcome|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.
Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386904|NCT00442611|O2|Outcome|IV Fluid|"The placebo arm will receive matched intravenous fluids.
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386905|NCT00442611|O1|Outcome|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.
Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386906|NCT00442611|O2|Outcome|IV Fluid|"The placebo arm will receive matched intravenous fluids.
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386907|NCT00442611|O1|Outcome|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.
Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386908|NCT00442611|E2|Reported Event|IV Fluid|"The placebo arm will receive matched intravenous fluids.
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386909|NCT00442611|E1|Reported Event|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.
Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion
Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
386910|NCT00442689|B4|Baseline|Total|Total of all reporting groups
386911|NCT00442689|B3|Baseline|Placebo - 3|Placebo
386912|NCT00442689|B2|Baseline|Flutamide - 2|"Flutamide
Flutamide: 250 mg twice daily"
386913|NCT00442689|B1|Baseline|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
386914|NCT00442689|P3|Participant Flow|Placebo - 3|Placebo only
386915|NCT00442689|P2|Participant Flow|Flutamide - 2|"Flutamide
Flutamide: 250 mg twice daily"
386916|NCT00442689|P1|Participant Flow|Oral Contraceptive - 1|"Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week"
386917|NCT00442689|O3|Outcome|Placebo - 3|Placebo
386918|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide
Flutamide: 250 mg twice daily"
386919|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
386920|NCT00442689|O3|Outcome|Placebo - 3|Placebo
386921|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide
Flutamide: 250 mg twice daily"
386922|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
386923|NCT00442689|O3|Outcome|Placebo - 3|Placebo
386924|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide
Flutamide: 250 mg twice daily"
386925|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
386926|NCT00442689|O3|Outcome|Placebo - 3|Placebo
386927|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide
Flutamide: 250 mg twice daily"
386928|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
386929|NCT00442689|O3|Outcome|Placebo - 3|Placebo
386930|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide
Flutamide: 250 mg twice daily"
386931|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
386932|NCT00442689|O3|Outcome|Placebo - 3|Placebo
386933|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide
Flutamide: 250 mg twice daily"
386934|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
386935|NCT00442689|O3|Outcome|Placebo - 3|Placebo
386936|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide
Flutamide: 250 mg twice daily"
386937|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
386938|NCT00442689|E3|Reported Event|Placebo - 3|Placebo only
386939|NCT00442689|E2|Reported Event|Flutamide - 2|"Flutamide
Flutamide: 250 mg twice daily"
386940|NCT00442689|E1|Reported Event|Oral Contraceptive - 1|"Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week"
386941|NCT00442702|B3|Baseline|Total|Total of all reporting groups
386942|NCT00442702|B2|Baseline|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
387072|NCT00443118|P3|Participant Flow|SIB-Without PEEP Valve|Self inflating bag without PEEP valve
386943|NCT00442702|B1|Baseline|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
386944|NCT00442702|P2|Participant Flow|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
386945|NCT00442702|P1|Participant Flow|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
386946|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
386947|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
386948|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
386949|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
386950|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
386951|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
386952|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
386953|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
386954|NCT00442702|E2|Reported Event|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
386955|NCT00442702|E1|Reported Event|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
386956|NCT00442897|B3|Baseline|Total|Total of all reporting groups
386957|NCT00442897|B2|Baseline|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
386958|NCT00442897|B1|Baseline|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
386959|NCT00442897|P2|Participant Flow|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
386960|NCT00442897|P1|Participant Flow|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
386961|NCT00442897|O2|Outcome|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
388734|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
386962|NCT00442897|O1|Outcome|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
386963|NCT00442897|O2|Outcome|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
386964|NCT00442897|O1|Outcome|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
386965|NCT00442897|E2|Reported Event|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
386966|NCT00442897|E1|Reported Event|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
386967|NCT00442936|B5|Baseline|Total|Total of all reporting groups
386968|NCT00442936|B4|Baseline|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386969|NCT00442936|B3|Baseline|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386970|NCT00442936|B2|Baseline|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
386971|NCT00442936|B1|Baseline|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
386972|NCT00442936|P4|Participant Flow|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386973|NCT00442936|P3|Participant Flow|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386974|NCT00442936|P2|Participant Flow|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
386975|NCT00442936|P1|Participant Flow|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
386976|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386977|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386978|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
386979|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
387060|NCT00443053|O2|Outcome|Placebo|Matching placebo
387576|NCT00450073|P1|Participant Flow|Vitamin D3|vitamin D3 50,000 IU weekly
387070|NCT00443118|B2|Baseline|Self Inflating Bag With PEEP|Subjects allocated to Self Inflating Bag with PEEP
386980|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386981|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386982|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
386983|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
386984|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386985|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386986|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
386987|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
386988|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386989|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386990|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
386991|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
386992|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386993|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386994|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
386995|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
386996|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
387061|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
387062|NCT00443053|O2|Outcome|Placebo|Matching placebo
387063|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
386997|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
386998|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
386999|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
387000|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
387001|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
387002|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
387003|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
387004|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
387005|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
387006|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
387007|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
387008|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
387009|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
387010|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
387011|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
387012|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
387013|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
387064|NCT00443053|O2|Outcome|Placebo|Matching placebo
387065|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
387066|NCT00443053|E2|Reported Event|Placebo|Matching placebo
387014|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
387015|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
387016|NCT00442936|E4|Reported Event|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
387017|NCT00442936|E3|Reported Event|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
387018|NCT00442936|E2|Reported Event|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
387019|NCT00442936|E1|Reported Event|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
387020|NCT00442962|B1|Baseline|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387021|NCT00442962|P1|Participant Flow|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387022|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387023|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387024|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387025|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387026|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387027|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387028|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387029|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387030|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387031|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387032|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387033|NCT00442962|E1|Reported Event|EFV+FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
387034|NCT00443040|B4|Baseline|Total|Total of all reporting groups
387035|NCT00443040|B3|Baseline|Placebo|Matching Placebo
387036|NCT00443040|B2|Baseline|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
387037|NCT00443040|B1|Baseline|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
387038|NCT00443040|P3|Participant Flow|Placebo|Matching Placebo
387039|NCT00443040|P2|Participant Flow|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
387040|NCT00443040|P1|Participant Flow|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
387041|NCT00443040|O3|Outcome|Placebo|Matching Placebo
387042|NCT00443040|O2|Outcome|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
387043|NCT00443040|O1|Outcome|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
387044|NCT00443040|E3|Reported Event|Placebo|Matching Placebo
387045|NCT00443040|E2|Reported Event|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
387046|NCT00443040|E1|Reported Event|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
387047|NCT00443053|B3|Baseline|Total|Total of all reporting groups
387048|NCT00443053|B2|Baseline|Placebo|Matching placebo
387049|NCT00443053|B1|Baseline|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
387050|NCT00443053|P2|Participant Flow|Placebo|Matching placebo
387051|NCT00443053|P1|Participant Flow|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
387052|NCT00443053|O2|Outcome|Placebo|Matching placebo
387053|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
387054|NCT00443053|O2|Outcome|Placebo|Matching placebo
387055|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
387056|NCT00443053|O2|Outcome|Placebo|Matching placebo
387057|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
387073|NCT00443118|P2|Participant Flow|SIB - With PEEP Valve|Subjects allocated to SIB with a PEEP valve attached
387074|NCT00443118|P1|Participant Flow|T-Piece|Subjects assigned to be resuscitated with T-Piece
387075|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to be resuscitated with Self Inflating Bag Without PEEP valve
387076|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
387077|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387078|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve
387079|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Without PEEP valve
387080|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387081|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocate to SIB Without PEEP valve
387082|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve
387083|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387084|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocated to SIB-Without PEEP valve
387085|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
387086|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387087|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocated to SIB-Without PEEP valve
387088|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
387089|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387090|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve
387091|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
387092|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387093|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Self Inflating Bag without PEEP valve
387094|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
387095|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387096|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag Without PEEP valve
387097|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
387098|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387099|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects Allocated to SIB without PEEP valve
387100|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve
387101|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387102|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag without PEEP valve
387103|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with a PEEP valve attached
387104|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387105|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Sujects allocated to be ventilated with Self Inflating Bag Without PEEP valve
387106|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to be ventilated using a Self Inlfating Bag with PEEP valve
387107|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387108|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag withouth a PEEP valve
387109|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
387110|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387111|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve attached
387112|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve attached
387113|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
387114|NCT00443118|E3|Reported Event|SIB Without PEEP|Subjects allocated to be ventilated with Self Inflating Bag without PEEP valve
387115|NCT00443118|E2|Reported Event|SIB - Self Inflating Bag With PEEP|Subjects allocated to be ventilated with Self Inflating Bag with PEEP valve
387116|NCT00443118|E1|Reported Event|T-Piece|Subjects assigned to be resuscitated with T-Piece
387117|NCT00443209|B3|Baseline|Total|Total of all reporting groups
387118|NCT00443209|B2|Baseline|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
387119|NCT00443209|B1|Baseline|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
387139|NCT00443352|P1|Participant Flow|Duloxetine|Duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
387577|NCT00450073|O3|Outcome|Sunlamp|Weekly use of a sunlamp
387120|NCT00443209|P2|Participant Flow|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
387143|NCT00443430|B2|Baseline|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
387121|NCT00443209|P1|Participant Flow|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
387122|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
387123|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
387124|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
387125|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
387126|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
387127|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
387128|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
387129|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
387130|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
387131|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
387132|NCT00443209|E2|Reported Event|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
387133|NCT00443209|E1|Reported Event|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
387134|NCT00443261|B1|Baseline|1: SCCHN|"Azacitidine and cisplatin
Azacitidine: SC azacitidine
Cisplatin: cisplatin 75 mg/m2 day 8 every 28 days"
387135|NCT00443261|P1|Participant Flow|Arm 1: SCCHN|"Intervention:
Azacitidine: SC daily X 5 every 28 days azacitidine at assigned dose ranging from 37 to 110 mg/M^2/day.
Cisplatin: cisplatin 75 mg/m^2 day 8 every 28 days"
387136|NCT00443261|O1|Outcome|Arm 1: SCCHN|"Azacitidine and cisplatin
Azacitidine: SC azacitidine
Cisplatin: cisplatin 75 mg/m^2 day 8 every 28 days"
387137|NCT00443261|E1|Reported Event|1: SCCHN|"Azacitidine and cisplatin
Azacitidine: SC azacitidine
Cisplatin: cisplatin 75 mg/m2 day 8 every 28 days"
387138|NCT00443352|B1|Baseline|Duloxetine Completers|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
387578|NCT00450073|O2|Outcome|Vitamin D2|vitamin D2 50,000 IU weekly
387141|NCT00443352|E1|Reported Event|Duloxetine|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
387142|NCT00443430|B3|Baseline|Total|Total of all reporting groups
387144|NCT00443430|B1|Baseline|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
387145|NCT00443430|P2|Participant Flow|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
387146|NCT00443430|P1|Participant Flow|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
387147|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
387148|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
387149|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
387150|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
387151|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
387152|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
387153|NCT00443430|E2|Reported Event|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
387154|NCT00443430|E1|Reported Event|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
387155|NCT00443456|B1|Baseline|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
387156|NCT00443456|P1|Participant Flow|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
387157|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
387158|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
387159|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
387160|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
387161|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
387162|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
387163|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
387164|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
387165|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
387166|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
387167|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
387168|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
387169|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
387170|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
387171|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
387172|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
387173|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
387174|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
387175|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
387176|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
387177|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
387178|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
387179|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
387180|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
387181|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
387182|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
387183|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
387184|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
387185|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
387186|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
387187|NCT00443456|E1|Reported Event|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study
387188|NCT00443534|B1|Baseline|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
387189|NCT00443534|P1|Participant Flow|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
387190|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
387191|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
387192|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
387193|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
387194|NCT00443534|E1|Reported Event|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
387195|NCT00443560|B3|Baseline|Total|Total of all reporting groups
387196|NCT00443560|B2|Baseline|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
387197|NCT00443560|B1|Baseline|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
387198|NCT00443560|P2|Participant Flow|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
387199|NCT00443560|P1|Participant Flow|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
387200|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
387201|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
387202|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
387203|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
387204|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
387205|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
387206|NCT00443560|E2|Reported Event|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
387207|NCT00443560|E1|Reported Event|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
387208|NCT00443599|B3|Baseline|Total|Total of all reporting groups
387209|NCT00443599|B2|Baseline|Standard Care|Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.
387210|NCT00443599|B1|Baseline|Tight Glycemic Control|Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
387211|NCT00443599|P2|Participant Flow|Standard Care|Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.
387212|NCT00443599|P1|Participant Flow|Tight Glycemic Control|Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
387213|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387214|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387215|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387216|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387217|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387218|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387219|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387220|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387221|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387222|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387223|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387224|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387427|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
387225|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387226|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387227|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387228|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387229|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387230|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387231|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387232|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387233|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387234|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387235|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387236|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387237|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387238|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387239|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.
Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
387240|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.
Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
387241|NCT00443599|E2|Reported Event|Usual Care|Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control.
387242|NCT00443599|E1|Reported Event|Insulin|Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
387243|NCT00443651|B3|Baseline|Total|Total of all reporting groups
387244|NCT00443651|B2|Baseline|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387245|NCT00443651|B1|Baseline|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387428|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
387246|NCT00443651|P2|Participant Flow|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
388735|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
387247|NCT00443651|P1|Participant Flow|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387248|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387249|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387250|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387251|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387252|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387253|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387254|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387255|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387256|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387257|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387276|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387429|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
387258|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387259|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387260|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387261|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387262|NCT00443651|E2|Reported Event|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387263|NCT00443651|E1|Reported Event|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
387264|NCT00443703|B3|Baseline|Total|Total of all reporting groups
387265|NCT00443703|B2|Baseline|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387266|NCT00443703|B1|Baseline|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387267|NCT00443703|P2|Participant Flow|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387268|NCT00443703|P1|Participant Flow|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387269|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387270|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387271|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387272|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387273|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387274|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387275|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387277|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387389|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387278|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387279|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387280|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387281|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387282|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387283|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387284|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387285|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387286|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387287|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387288|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387289|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387290|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387291|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387292|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387293|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387294|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387295|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387296|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387297|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387424|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
387298|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387299|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387300|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387301|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387302|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387303|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387304|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387305|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387306|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387307|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387308|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387309|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387310|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387311|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387312|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387313|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387314|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387315|NCT00443703|E2|Reported Event|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387316|NCT00443703|E1|Reported Event|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387317|NCT00443729|B3|Baseline|Total|Total of all reporting groups
387318|NCT00443729|B2|Baseline|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387319|NCT00443729|B1|Baseline|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387320|NCT00443729|P2|Participant Flow|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387321|NCT00443729|P1|Participant Flow|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387322|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387323|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387324|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387325|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387326|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387327|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387328|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387329|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387330|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387331|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387332|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387333|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387334|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387335|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387336|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387337|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387338|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387339|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387340|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387430|NCT00443820|E4|Reported Event|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
387341|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387342|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387343|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387344|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387345|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387346|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387347|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387348|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387349|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387350|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387351|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387352|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387353|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387354|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387355|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387356|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387357|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387358|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387359|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387360|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387361|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387425|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
387362|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387363|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387364|NCT00443729|E2|Reported Event|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387365|NCT00443729|E1|Reported Event|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
387366|NCT00443755|B3|Baseline|Total|Total of all reporting groups
387367|NCT00443755|B2|Baseline|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387368|NCT00443755|B1|Baseline|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387369|NCT00443755|P2|Participant Flow|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387370|NCT00443755|P1|Participant Flow|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387371|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387372|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387373|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387374|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387375|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387376|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387377|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387378|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387379|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387380|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387381|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387382|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387383|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387384|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387385|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387386|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387387|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387388|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387581|NCT00450073|E2|Reported Event|Vitamin D2|vitamin D2 50,000 IU weekly
387390|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387391|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387392|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387393|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387394|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387395|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387396|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387397|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387398|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387399|NCT00443755|E2|Reported Event|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
387400|NCT00443755|E1|Reported Event|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
387401|NCT00443781|B1|Baseline|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
387402|NCT00443781|P1|Participant Flow|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
387403|NCT00443781|O1|Outcome|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
387404|NCT00443781|E1|Reported Event|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
387405|NCT00443820|B5|Baseline|Total|Total of all reporting groups
387406|NCT00443820|B4|Baseline|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
387407|NCT00443820|B3|Baseline|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
387408|NCT00443820|B2|Baseline|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
387409|NCT00443820|B1|Baseline|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
387410|NCT00443820|P4|Participant Flow|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
387411|NCT00443820|P3|Participant Flow|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
387412|NCT00443820|P2|Participant Flow|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
387413|NCT00443820|P1|Participant Flow|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
387414|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
387415|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
387416|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
387417|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
387418|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
387419|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
387420|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
387421|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
387422|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
387423|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
387579|NCT00450073|O1|Outcome|Vitamin D3|vitamin D3 50,000 IU weekly
387431|NCT00443820|E3|Reported Event|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
387432|NCT00443820|E2|Reported Event|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
387433|NCT00443820|E1|Reported Event|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
387582|NCT00450073|E1|Reported Event|Vitamin D3|vitamin D3 50,000 IU weekly
387434|NCT00443872|B1|Baseline|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
387435|NCT00443872|P1|Participant Flow|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
387436|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (MMSE)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
387437|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (BAI)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
387438|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (BDI)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
387439|NCT00443872|O1|Outcome|All Subjects PDQ-39|This includes all patients in the study. They all received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks which was increased to 2.5 mg once daily if tolerated.
387440|NCT00443872|O1|Outcome|All Subjects With DA Related AEs (UPDRS Data)|For all completed subjects (60) UPDRS activities of daily living scores and motor scores were collected. All patients received 1.25 mg once daily orally disintegrating selegiline for 6 weeks which was increased to 2.5mg once daily at 12 weeks if tolerated.
387441|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Impulse Control Disorder)|Patients who are experiencing dopamine agonist (DA) related adverse effect (AE) of impulse control disorder (ICD) received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks after which it was increased to 2.5mg once daily if tolerated.
387442|NCT00443872|O1|Outcome|PD Patiens With DA Related AE (Pedal Edema)|Patients who are experiencing a dopamine agonist (DA) related AE of pedal edema received 1.25mg once daily of orally disintegrating selegiline for 6 weeks after which there was an increase to 2.5 mg once daily if tolerated.
387443|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Hallucinations)|Patients who are experiencing the dopamine agonist (DA) related adverse effect of hallucinations. The participants received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks after which it was increased to 2.5 mg once daily if tolerated.
387444|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Daytime Sleepiness)|Patients who are experiencing a dopamine agonist (DA) related adverse effect (AE) of daytime sleepiness received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for the remaining 6 weeks if tolerated.
387445|NCT00443872|O1|Outcome|PD Patients With DA Related AE|Patients who are experiencing a dopamine agonist (DA) related adverse effect (AE) of either one or more of the following: excessive daytime sleepiness, hallucinations, pedal edema, impulse control disorder, received 1.25 mg once daily orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for remaining 6 weeks if tolerated.
387446|NCT00443872|E1|Reported Event|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
387447|NCT00443898|B5|Baseline|Total|Total of all reporting groups
387448|NCT00443898|B4|Baseline|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
387449|NCT00443898|B3|Baseline|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
387450|NCT00443898|B2|Baseline|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
387451|NCT00443898|B1|Baseline|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
387452|NCT00443898|P4|Participant Flow|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
387453|NCT00443898|P3|Participant Flow|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
387454|NCT00443898|P2|Participant Flow|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
387455|NCT00443898|P1|Participant Flow|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
387456|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
387457|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
387458|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
387459|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
387460|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
387461|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
387462|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
387463|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
387464|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
387465|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
387466|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
387467|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
387468|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
387469|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
387470|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
387580|NCT00450073|E3|Reported Event|Sunlamp|Weekly use of a sunlamp
387471|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
387472|NCT00443898|E4|Reported Event|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
387583|NCT00450112|B3|Baseline|Total|Total of all reporting groups
387473|NCT00443898|E3|Reported Event|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
387474|NCT00443898|E2|Reported Event|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
387475|NCT00443898|E1|Reported Event|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
387476|NCT00444067|B3|Baseline|Total|Total of all reporting groups
387477|NCT00444067|B2|Baseline|Control|Standard of care methods used as an adjunct to sutured dural repair.
387478|NCT00444067|B1|Baseline|Spinal Sealant|DuraSeal Spinal Sealant System
387479|NCT00444067|P2|Participant Flow|Control|Standard of care methods used as an adjunct to sutured dural repair.
387480|NCT00444067|P1|Participant Flow|Spinal Sealant|DuraSeal Spinal Sealant System
387481|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
387482|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
387483|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
387484|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
387485|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
387486|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
387487|NCT00444067|E2|Reported Event|Control|Standard of care methods used as an adjunct to sutured dural repair.
387488|NCT00444067|E1|Reported Event|Spinal Sealant|DuraSeal Spinal Sealant System
387489|NCT00444106|B4|Baseline|Total|Total of all reporting groups
387490|NCT00444106|B3|Baseline|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
387491|NCT00444106|B2|Baseline|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
387492|NCT00444106|B1|Baseline|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
387493|NCT00444106|P3|Participant Flow|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
387494|NCT00444106|P2|Participant Flow|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
387495|NCT00444106|P1|Participant Flow|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
387496|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin)250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
387497|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) 250mg tablets once daily for 3 days dosage dependent on body weight.
387498|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
387499|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
387500|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
387501|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
387502|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin)250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
387503|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) 250mg tablets once daily for 3 days dosage dependent on body weight.
387504|NCT00444106|O1|Outcome|Artemether-lumefantrine|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
387505|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
387506|NCT00444106|E3|Reported Event|Artesunate-Mefloquine|Artesunate-Mefloquine
387507|NCT00444106|E2|Reported Event|Atovaquone-proguanil|Atovaquone-proguanil
387508|NCT00444106|E1|Reported Event|Artemether-lumefantrine|Artemether-lumefantrine
387509|NCT00444145|B1|Baseline|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.
Prevacid: 30 mg bid for 3 months
Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
387510|NCT00444145|P1|Participant Flow|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.
Prevacid: 30 mg bid for 3 months
Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
387511|NCT00444145|O1|Outcome|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.
Prevacid: 30 mg bid for 3 months
Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
407030|NCT00504426|E2|Reported Event|OPC-249 (30IU)|30 IU of OPC-249/vial
387726|NCT00452335|O3|Outcome|24 Mch BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
388736|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
387512|NCT00444145|E1|Reported Event|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.
Prevacid: 30 mg bid for 3 months
Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
387513|NCT00444275|B4|Baseline|Total|Total of all reporting groups
387514|NCT00444275|B3|Baseline|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387515|NCT00444275|B2|Baseline|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387516|NCT00444275|B1|Baseline|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387517|NCT00444275|P5|Participant Flow|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387518|NCT00444275|P4|Participant Flow|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387519|NCT00444275|P3|Participant Flow|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387520|NCT00444275|P2|Participant Flow|Esomeprazole 40 mg Once Daily (Initial Phase)|
387521|NCT00444275|P1|Participant Flow|Esomeprazole 20 mg Once Daily (Initial Phase)|
387522|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387523|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387524|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387525|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
387526|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
387527|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387528|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387529|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387530|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
387531|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
387532|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387533|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387534|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387535|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
387536|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
387537|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387538|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387539|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387540|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
387541|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
387542|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387543|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387544|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387545|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
387546|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
387547|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387548|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387549|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387550|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
387551|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
387552|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387553|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387554|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387555|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
387556|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
387557|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387558|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387559|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387560|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
387561|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
387562|NCT00444275|O3|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387563|NCT00444275|O2|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387564|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387565|NCT00444275|E5|Reported Event|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
387566|NCT00444275|E4|Reported Event|Esomeprazole 20 mg on Demand (Maintenance Phase)|
387567|NCT00444275|E3|Reported Event|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
387568|NCT00444275|E2|Reported Event|Esomeprazole 40 mg Once Daily (Initial Phase)|
387569|NCT00444275|E1|Reported Event|Esomeprazole 20 mg Once Daily (Initial Phase)|
387570|NCT00450073|B4|Baseline|Total|Total of all reporting groups
387571|NCT00450073|B3|Baseline|Sunlamp|Use of a sunlamp 5 times a week for 12 weeks
387572|NCT00450073|B2|Baseline|Vitamin D2|vitamin D2 50,000 IU weekly
387573|NCT00450073|B1|Baseline|Vitamin D3|vitamin D3 50,000 IU weekly
387574|NCT00450073|P3|Participant Flow|Sunlamp|Use of a sunlamp 5 times a week for 12 weeks.
387575|NCT00450073|P2|Participant Flow|Vitamin D2|vitamin D2 50,000 IU weekly
387584|NCT00450112|B2|Baseline|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387585|NCT00450112|B1|Baseline|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387586|NCT00450112|P2|Participant Flow|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387587|NCT00450112|P1|Participant Flow|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387588|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387589|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387590|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387591|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387592|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387593|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387594|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387595|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387596|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387597|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387598|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387599|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387600|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387601|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387602|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387603|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387604|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387856|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387605|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387606|NCT00450112|E2|Reported Event|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
387607|NCT00450112|E1|Reported Event|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
387608|NCT00450216|B3|Baseline|Total|Total of all reporting groups
387609|NCT00450216|B2|Baseline|Ibuprofen|Ibuprofen 800mg
387610|NCT00450216|B1|Baseline|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
387611|NCT00450216|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg tablets t.i.d.
387612|NCT00450216|P1|Participant Flow|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg tablets t.i.d.
387613|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
387614|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
387615|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
387616|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
387617|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
387618|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
387619|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
387620|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
387621|NCT00450216|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
387622|NCT00450216|E1|Reported Event|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
387623|NCT00450242|B3|Baseline|Total|Total of all reporting groups
387624|NCT00450242|B2|Baseline|Placebo Cream|
387625|NCT00450242|B1|Baseline|5% Lidocaine Cream|5% topical lidocaine cream.
387626|NCT00450242|P2|Participant Flow|Placebo Cream|
387627|NCT00450242|P1|Participant Flow|5% Lidocaine Cream|5% topical lidocaine cream.
387628|NCT00450242|O2|Outcome|Placebo Cream|Topical cream vehicle.
387629|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
387630|NCT00450242|O2|Outcome|Placebo Cream|topical cream vehicle.
387631|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
387632|NCT00450242|O2|Outcome|Placebo Cream|
387633|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
387634|NCT00450242|O2|Outcome|Placebo Cream|Topical cream vehicle.
387635|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
387636|NCT00450242|E2|Reported Event|Placebo Cream|
387637|NCT00450242|E1|Reported Event|5% Lidocaine Cream|5% topical lidocaine cream.
387638|NCT00450255|B1|Baseline|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
pharmacological study: Correlative studies"
387639|NCT00450255|P1|Participant Flow|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
pharmacological study: Correlative studies"
387640|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
pharmacological study: Correlative studies"
387641|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
pharmacological study: Correlative studies"
387642|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
pharmacological study: Correlative studies"
387643|NCT00450255|E1|Reported Event|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
pharmacological study: Correlative studies"
387644|NCT00450294|B1|Baseline|Longitudinal Group|This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
387645|NCT00450294|P1|Participant Flow|Longitudinal Study Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.Measurement of Central venous pressure at event intervals during abdominal aortic aneurysm repair. Data are presented as mean +/- standard error.
387646|NCT00450294|O1|Outcome|Longitudinal Study Group|This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair.
387687|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:
Rituximab 375 mg/m2 on day 1
Cyclophosphamide 750 mg/m2 IV on day 1
Doxorubicin 50 mg/m2 on day 1
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
Prednisone 100 mg orally days 1-5, repeated every 21 days."
387857|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387688|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:
Rituximab 375 mg/m2 on day 1
Cyclophosphamide 750 mg/m2 IV on day 1
Doxorubicin 50 mg/m2 on day 1
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
Prednisone 100 mg orally days 1-5, repeated every 21 days."
387647|NCT00450294|O1|Outcome|Longitudinal Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
387648|NCT00450294|E1|Reported Event|Longitudinal Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
387649|NCT00450333|B5|Baseline|Total|Total of all reporting groups
387650|NCT00450333|B4|Baseline|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
387651|NCT00450333|B3|Baseline|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
387652|NCT00450333|B2|Baseline|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
387653|NCT00450333|B1|Baseline|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
387654|NCT00450333|P4|Participant Flow|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
387655|NCT00450333|P3|Participant Flow|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
387656|NCT00450333|P2|Participant Flow|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
387657|NCT00450333|P1|Participant Flow|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
387658|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
387659|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
387660|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
387661|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
387662|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
387663|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
387664|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
387665|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
387666|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
387667|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
387668|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
387669|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
387670|NCT00450333|E4|Reported Event|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
387671|NCT00450333|E3|Reported Event|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
387672|NCT00450333|E2|Reported Event|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
387673|NCT00450333|E1|Reported Event|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
387674|NCT00450372|B1|Baseline|Single Arm|
387675|NCT00450372|P1|Participant Flow|Single Arm|
387676|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without ASS expression in tumor
387677|NCT00450372|O1|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with ASS expression present in tumor
387678|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without ASS expression in tumor
387679|NCT00450372|O1|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with ASS expression present in tumor
387680|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without Argininosuccinate Synthetase (ASS) expression present in tumor
387681|NCT00450372|O1|Outcome|ADI-PED 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with Argininosuccinate Synthetase (ASS) expression present in tumor
387682|NCT00450372|E1|Reported Event|Single Arm|
387683|NCT00450385|B1|Baseline|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:
Rituximab 375 mg/m2 on day 1
Cyclophosphamide 750 mg/m2 IV on day 1
Doxorubicin 50 mg/m2 on day 1
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
Prednisone 100 mg orally days 1-5, repeated every 21 days."
387684|NCT00450385|P1|Participant Flow|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:
Rituximab 375 mg/m2 on day 1
Cyclophosphamide 750 mg/m2 IV on day 1
Doxorubicin 50 mg/m2 on day 1
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
Prednisone 100 mg orally days 1-5, repeated every 21 days."
387685|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:
Rituximab 375 mg/m2 on day 1
Cyclophosphamide 750 mg/m2 IV on day 1
Doxorubicin 50 mg/m2 on day 1
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
Prednisone 100 mg orally days 1-5, repeated every 21 days.
Rituximab: Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles
Cyclophosphamide: Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles
Doxorubicin: Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles
Prednisone: Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.
Vincristine: Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles"
387686|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:
Rituximab 375 mg/m2 on day 1
Cyclophosphamide 750 mg/m2 IV on day 1
Doxorubicin 50 mg/m2 on day 1
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
Prednisone 100 mg orally days 1-5, repeated every 21 days."
387689|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:
Rituximab 375 mg/m2 on day 1
Cyclophosphamide 750 mg/m2 IV on day 1
Doxorubicin 50 mg/m2 on day 1
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
Prednisone 100 mg orally days 1-5, repeated every 21 days."
387690|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:
Rituximab 375 mg/m2 on day 1
Cyclophosphamide 750 mg/m2 IV on day 1
Doxorubicin 50 mg/m2 on day 1
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
Prednisone 100 mg orally days 1-5, repeated every 21 days."
387691|NCT00450385|E1|Reported Event|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:
Rituximab 375 mg/m2 on day 1
Cyclophosphamide 750 mg/m2 IV on day 1
Doxorubicin 50 mg/m2 on day 1
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
Prednisone 100 mg orally days 1-5, repeated every 21 days."
387692|NCT00452114|B3|Baseline|Total|Total of all reporting groups
387693|NCT00452114|B2|Baseline|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
387694|NCT00452114|B1|Baseline|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
387695|NCT00452114|P2|Participant Flow|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
387696|NCT00452114|P1|Participant Flow|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
387697|NCT00452114|O2|Outcome|Particpants in the Control Group (Flutter Device)|
387698|NCT00452114|O1|Outcome|Participants in the Intervention Group (Cough In-exsufflator)|
387699|NCT00452114|E2|Reported Event|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
387700|NCT00452114|E1|Reported Event|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
387701|NCT00452335|B4|Baseline|Total|Total of all reporting groups
387702|NCT00452335|B3|Baseline|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
387703|NCT00452335|B2|Baseline|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387704|NCT00452335|B1|Baseline|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387705|NCT00452335|P3|Participant Flow|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
387706|NCT00452335|P2|Participant Flow|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387707|NCT00452335|P1|Participant Flow|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387708|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
387709|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387710|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387711|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
387712|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387713|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387714|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
387715|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387716|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387717|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
387718|NCT00452335|O2|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387719|NCT00452335|O1|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387720|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
387721|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387722|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387723|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
387724|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
389120|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
387725|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387727|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387728|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387729|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
387730|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387731|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387732|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
387733|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387734|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387735|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
387736|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387737|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387738|NCT00452335|E3|Reported Event|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
387739|NCT00452335|E2|Reported Event|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
387740|NCT00452335|E1|Reported Event|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
387741|NCT00452348|B3|Baseline|Total|Total of all reporting groups
387742|NCT00452348|B2|Baseline|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
387743|NCT00452348|B1|Baseline|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
387744|NCT00452348|P2|Participant Flow|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
387745|NCT00452348|P1|Participant Flow|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
387746|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
387747|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
387748|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
387749|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
387750|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
387751|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
387752|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
387753|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
387754|NCT00452348|E2|Reported Event|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
387755|NCT00452348|E1|Reported Event|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
387756|NCT00452361|B3|Baseline|Total|Total of all reporting groups
387757|NCT00452361|B2|Baseline|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387758|NCT00452361|B1|Baseline|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387837|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387838|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387839|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387858|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387859|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387860|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387759|NCT00452361|P2|Participant Flow|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387760|NCT00452361|P1|Participant Flow|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387761|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387762|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387763|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387764|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387765|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387766|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387767|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387768|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387840|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387841|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387842|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387843|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387769|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387770|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387771|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387772|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387773|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387774|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387775|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387776|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387777|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387778|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387844|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387845|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387846|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387847|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
407031|NCT00504426|E1|Reported Event|Placebo|Placebo of OPC-249/vial
387779|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387780|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387781|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387782|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387783|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387784|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387785|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387786|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387787|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387788|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387848|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387849|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387850|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387851|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
413927|NCT00522925|B1|Baseline|1- Placebo|Placebo
387789|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387790|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387791|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387792|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387793|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387794|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387795|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387796|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387797|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387798|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387852|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387853|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387854|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387855|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
413932|NCT00522925|O2|Outcome|2- PS433540 200mg|200mg daily for 4 weeks
387799|NCT00452361|E2|Reported Event|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
387800|NCT00452361|E1|Reported Event|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
387801|NCT00452374|B1|Baseline|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
387802|NCT00452374|P1|Participant Flow|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
387803|NCT00452374|O1|Outcome|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
387804|NCT00452374|O1|Outcome|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
387805|NCT00452374|E1|Reported Event|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
387806|NCT00452387|B1|Baseline|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
387807|NCT00452387|P1|Participant Flow|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
387808|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
387809|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
387810|NCT00452387|O2|Outcome|Imaging Response (Unfavorable)|
387811|NCT00452387|O1|Outcome|Imaging Response (Favorable)|
387812|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
387813|NCT00452387|E1|Reported Event|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
387814|NCT00452400|B6|Baseline|Total|Total of all reporting groups
387815|NCT00452400|B5|Baseline|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387816|NCT00452400|B4|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387817|NCT00452400|B3|Baseline|Olo 5 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387818|NCT00452400|B2|Baseline|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387819|NCT00452400|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387820|NCT00452400|P5|Participant Flow|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387821|NCT00452400|P4|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387822|NCT00452400|P3|Participant Flow|Olo 5 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387823|NCT00452400|P2|Participant Flow|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387824|NCT00452400|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387825|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387826|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387827|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387828|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387829|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387830|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387831|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387832|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387833|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387834|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387835|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387836|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
413933|NCT00522925|O1|Outcome|1- Placebo|Placebo
387861|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387862|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387863|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387864|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387865|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387866|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387867|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387868|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387869|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387870|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387871|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387872|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387873|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387874|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387875|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387876|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387877|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387878|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387879|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387880|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387881|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387882|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387883|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387884|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387885|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387886|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387887|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387888|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387889|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387890|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387891|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387892|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387893|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387894|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387895|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387896|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387897|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387898|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387899|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387900|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387901|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387902|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387903|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387904|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387905|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387906|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387907|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387908|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387909|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387910|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387911|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387912|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387913|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387914|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387915|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387916|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387917|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387918|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387919|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387920|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387921|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387922|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387923|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387924|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387925|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387926|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387927|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387928|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387929|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387930|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387931|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387932|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387933|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387934|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387935|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387936|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387937|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387938|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387939|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387940|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387941|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387942|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387943|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387944|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387945|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387946|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387947|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387948|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387949|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387950|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387951|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387952|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387953|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387954|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387955|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387956|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387957|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387958|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387959|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387960|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387961|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387962|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387963|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387964|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387965|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387966|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387967|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387968|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387969|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387970|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387971|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387972|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387973|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387974|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387975|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387976|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387977|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387978|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387979|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387980|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387981|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387982|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387983|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387984|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387985|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387986|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387987|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387988|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387989|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387990|NCT00452400|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
387991|NCT00452400|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
387992|NCT00452400|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
387993|NCT00452400|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
387994|NCT00452400|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
387995|NCT00452426|B3|Baseline|Total|Total of all reporting groups
387996|NCT00452426|B2|Baseline|Current Standard of Care|Site's current standard used for delivery of sedation
387997|NCT00452426|B1|Baseline|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
387998|NCT00452426|P2|Participant Flow|Current Standard of Care|Site's current standard used for delivery of sedation
387999|NCT00452426|P1|Participant Flow|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
388000|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
388001|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
388002|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
388003|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
388004|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
388005|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
388006|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
388007|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
388008|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
388009|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
388010|NCT00452426|E2|Reported Event|Current Standard of Care|Site's current standard used for delivery of sedation
388011|NCT00452426|E1|Reported Event|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
388012|NCT00452452|B4|Baseline|Total|Total of all reporting groups
388013|NCT00452452|B3|Baseline|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
388014|NCT00452452|B2|Baseline|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
388015|NCT00452452|B1|Baseline|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
388016|NCT00452452|P3|Participant Flow|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
388017|NCT00452452|P2|Participant Flow|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
388018|NCT00452452|P1|Participant Flow|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
388019|NCT00452452|O3|Outcome|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
388020|NCT00452452|O2|Outcome|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
388021|NCT00452452|O1|Outcome|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
388022|NCT00452452|O6|Outcome|13vPnC Group 1 - Dose 3|Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
388023|NCT00452452|O5|Outcome|13vPnC Group 2 - Dose 2|Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
388024|NCT00452452|O4|Outcome|13vPnC Group 1 - Dose 2|Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
388025|NCT00452452|O3|Outcome|13vPnC Group 3 - Dose 1|Participants 24 to < 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
388026|NCT00452452|O2|Outcome|13vPnC Group 2 - Dose 1|Participants 12 to < 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
388027|NCT00452452|O1|Outcome|13vPnC Group 1 - Dose 1|Participants 7 to less than (<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
388028|NCT00452452|O6|Outcome|13vPnC Group 1 - Dose 3|Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
388029|NCT00452452|O5|Outcome|13vPnC Group 2 - Dose 2|Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
388030|NCT00452452|O4|Outcome|13vPnC Group 1 - Dose 2|Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
388031|NCT00452452|O3|Outcome|13vPnC Group 3 - Dose 1|Participants 24 to < 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
388032|NCT00452452|O2|Outcome|13vPnC Group 2 - Dose 1|Participants 12 to < 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
388033|NCT00452452|O1|Outcome|13vPnC Group 1 - Dose 1|Participants 7 to less than (<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
388034|NCT00452452|O3|Outcome|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
388035|NCT00452452|O2|Outcome|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
388036|NCT00452452|O1|Outcome|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
388037|NCT00452452|E3|Reported Event|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
388038|NCT00452452|E2|Reported Event|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
388039|NCT00452452|E1|Reported Event|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
388040|NCT00452530|B3|Baseline|Total|Total of all reporting groups
388041|NCT00452530|B2|Baseline|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
388042|NCT00452530|B1|Baseline|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
388043|NCT00452530|P2|Participant Flow|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
388044|NCT00452530|P1|Participant Flow|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
388045|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
388046|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
388047|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
388048|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
388049|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
388050|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
388051|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
388052|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
388053|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
388054|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
388055|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
442811|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
388056|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
388057|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
388058|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
388059|NCT00452530|E2|Reported Event|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
388060|NCT00452530|E1|Reported Event|Apixiban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
388061|NCT00452543|B3|Baseline|Total|Total of all reporting groups
388062|NCT00452543|B2|Baseline|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
388063|NCT00452543|B1|Baseline|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
388064|NCT00452543|P2|Participant Flow|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
388065|NCT00452543|P1|Participant Flow|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
388066|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
388067|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
388068|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
388069|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
388070|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
388071|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
388072|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
388073|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
388074|NCT00452543|E2|Reported Event|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
388075|NCT00452543|E1|Reported Event|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
388076|NCT00452673|B5|Baseline|Total|Total of all reporting groups
388077|NCT00452673|B4|Baseline|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
388078|NCT00452673|B3|Baseline|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
388079|NCT00452673|B2|Baseline|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
388080|NCT00452673|B1|Baseline|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
388081|NCT00452673|P5|Participant Flow|100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Expansion)|No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for the dose expansion period in order to provide additional information regarding good tolerance of extended treatment. An additional 21 participants were treated in this arm in the Dose Expansion Period.
388082|NCT00452673|P4|Participant Flow|100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation)|Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
388083|NCT00452673|P3|Participant Flow|70 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation)|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
388084|NCT00452673|P2|Participant Flow|70 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation)|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
388120|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
388121|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
388122|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
388123|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
389567|NCT00455702|O2|Outcome|Placebo|"50 mg placebo
d-cycloserine: 50mg dose d-cycloserine v placebo"
388126|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
388127|NCT00452699|E2|Reported Event|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
388085|NCT00452673|P1|Participant Flow|50 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation)|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
388086|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
388087|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
388088|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
388089|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
388090|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
388091|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
388092|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
388093|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
388094|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
388095|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
388096|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
388097|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
388098|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
388099|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
388100|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
388124|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
389663|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
388101|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
388102|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
388103|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
388104|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
388105|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
388106|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
388107|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
388108|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
388109|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
388110|NCT00452673|E4|Reported Event|100 mg Dasatinib + 1000 mg/m^2 Capecitabine|Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
388111|NCT00452673|E3|Reported Event|70 mg Dasatinib + 1000 mg/m^2 Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
388112|NCT00452673|E2|Reported Event|70 mg Dasatinib + 825 mg/m^2 Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
388113|NCT00452673|E1|Reported Event|50 mg Dasatinib + 825 mg/m^2 Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
388114|NCT00452699|B3|Baseline|Total|Total of all reporting groups
388115|NCT00452699|B2|Baseline|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
388116|NCT00452699|B1|Baseline|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
388117|NCT00452699|P2|Participant Flow|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
388118|NCT00452699|P1|Participant Flow|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
388119|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
388125|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
388128|NCT00452699|E1|Reported Event|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
388129|NCT00452790|B3|Baseline|Total|Total of all reporting groups
388130|NCT00452790|B2|Baseline|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388131|NCT00452790|B1|Baseline|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388132|NCT00452790|P2|Participant Flow|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388133|NCT00452790|P1|Participant Flow|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388134|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388135|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388136|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388137|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388138|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388139|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388140|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388141|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388142|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388143|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388365|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388144|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388145|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388146|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388147|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388148|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388149|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388150|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388151|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388152|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388153|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388154|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388155|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388156|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388157|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388158|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388449|NCT00453999|P2|Participant Flow|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
388159|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388160|NCT00452790|E6|Reported Event|Toddler Dose 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 12 months of age (toddler dose).
388161|NCT00452790|E5|Reported Event|Toddler Dose 13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 12 months of age (toddler dose).
388162|NCT00452790|E4|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
388163|NCT00452790|E3|Reported Event|After the Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
388164|NCT00452790|E2|Reported Event|Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388165|NCT00452790|E1|Reported Event|Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
388166|NCT00452868|B1|Baseline|Donepezil|
388167|NCT00452868|P1|Participant Flow|Donepezil|Patients less than 35 kilograms(kg): Donepezil 5 milligrams (mg) orally once every alternate day. Patients greater than 35 kg Donepezil 5 mg orally once per day. If there are no adverse effects noted on review of symptoms, the dose will be increased to 5 mg daily for patients < 35 kg. And to 10 mg/day for patients > 35 kg. This evaluation and dose escalation may be done as early as week 4. For all, donepezil will be administered 24 weeks.
388168|NCT00452868|O1|Outcome|Donepezil|
388169|NCT00452868|E1|Reported Event|Donepezil|
388170|NCT00453063|B3|Baseline|Total|Total of all reporting groups
388171|NCT00453063|B2|Baseline|Placebo|Two sprays in each nostril once daily
388172|NCT00453063|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
388173|NCT00453063|P2|Participant Flow|Placebo|Two sprays in each nostril once daily
388174|NCT00453063|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
388175|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
388176|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
388177|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
388178|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
388179|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
388180|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
388181|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
388182|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
388183|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
388184|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
388185|NCT00453063|E2|Reported Event|Placebo|Two sprays in each nostril once daily
388186|NCT00453063|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
388187|NCT00453102|B1|Baseline|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
388188|NCT00453102|P1|Participant Flow|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
388362|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388489|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388189|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
388190|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
388191|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
388192|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
388193|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
388194|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
388195|NCT00453102|E1|Reported Event|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
388196|NCT00453154|B4|Baseline|Total|Total of all reporting groups
388197|NCT00453154|B3|Baseline|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle
Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
388198|NCT00453154|B2|Baseline|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle
Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
388199|NCT00453154|B1|Baseline|Phase I|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle
Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
388200|NCT00453154|P4|Participant Flow|Double Blind Sunitinib Maintenance|Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
388201|NCT00453154|P3|Participant Flow|Double Blind Placebo Maintenance With Optional Crossover|"Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
At progression, participants receiving placebo could cross over to receive open label sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
388202|NCT00453154|P2|Participant Flow|Phase II Combination Chemotherapy|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IVover 1 hour on days 1, 2, and 3 every cycle"
388203|NCT00453154|P1|Participant Flow|Phase 1B|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle
Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
388363|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388684|NCT00454532|E2|Reported Event|Level 2|20g/day
388685|NCT00454532|E1|Reported Event|Level 1|10g/day
388204|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle
Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
388205|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle
Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
388206|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle
Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
388207|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle
Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
388208|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle
Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
388209|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle
Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
388210|NCT00453154|O3|Outcome|Cohort 3|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 50 mg oral, daily days 1-14 every cycle
Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
388211|NCT00453154|O2|Outcome|Cohort 2|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 37.5 mg oral, daily days 1-14 every cycle
Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
388212|NCT00453154|O1|Outcome|Cohort 1|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):
Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle
Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
388213|NCT00453154|E2|Reported Event|Arm II (Combination Chemotherapy + Placebo Maintenance)|Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
388214|NCT00453154|E1|Reported Event|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
388215|NCT00453180|B3|Baseline|Total|Total of all reporting groups
388216|NCT00453180|B2|Baseline|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.
Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
388217|NCT00453180|B1|Baseline|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
388218|NCT00453180|P2|Participant Flow|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.
Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
388219|NCT00453180|P1|Participant Flow|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
388220|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.
Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
388221|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
388222|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.
Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
388686|NCT00454571|B3|Baseline|Total|Total of all reporting groups
388223|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
388224|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.
Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
388225|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
388226|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.
Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
388227|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
388228|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.
Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
388229|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
388230|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.
Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
388231|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
388232|NCT00453180|E2|Reported Event|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain in active ingredients.
Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
388233|NCT00453180|E1|Reported Event|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
388234|NCT00453193|B1|Baseline|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
388235|NCT00453193|P1|Participant Flow|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
388236|NCT00453193|O1|Outcome|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
388237|NCT00453193|E1|Reported Event|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
388238|NCT00453206|B1|Baseline|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
388239|NCT00453206|P1|Participant Flow|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
388240|NCT00453206|O1|Outcome|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
388241|NCT00453206|E1|Reported Event|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
388242|NCT00453310|B1|Baseline|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)
sunitinib malate"
388243|NCT00453310|P1|Participant Flow|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)
sunitinib malate"
388244|NCT00453310|O1|Outcome|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)
sunitinib malate"
388245|NCT00453310|E1|Reported Event|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)
sunitinib malate"
388364|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388725|NCT00441766|B5|Baseline|Total|Total of all reporting groups
388246|NCT00453336|B1|Baseline|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.
Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
388247|NCT00453336|P1|Participant Flow|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.
Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
388248|NCT00453336|O1|Outcome|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.
Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
388249|NCT00453336|O1|Outcome|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.
Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
388250|NCT00453336|E1|Reported Event|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.
Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
388251|NCT00453349|B3|Baseline|Total|Total of all reporting groups
388252|NCT00453349|B2|Baseline|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388253|NCT00453349|B1|Baseline|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388254|NCT00453349|P2|Participant Flow|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388255|NCT00453349|P1|Participant Flow|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388256|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388257|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388258|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388259|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388260|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388261|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388262|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388263|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388264|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388265|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388266|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388267|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388268|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388269|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388270|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388271|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388272|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388273|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388274|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388275|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388276|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388277|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388278|NCT00453349|E2|Reported Event|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
388279|NCT00453349|E1|Reported Event|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
388280|NCT00453362|B1|Baseline|Erlotinib|Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
388281|NCT00453362|P1|Participant Flow|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET (2-deoxy-2-[18F]fluoro-D-glucose-Positron Emission Tomogrpahy)and FLT-PET (3'-deoxy-3'-[18F]fluorothymidine-Positron Emission Tomogrpahy) scans.
FDG-PET intravenous injection dosage was based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose was 7 mCi."
388282|NCT00453362|O1|Outcome|Overall Study Participants|"All Participants who underwent any FLT-PET scan during the study (including screening) were included in the analysis.
FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
388283|NCT00453362|O2|Outcome|Erlotinib_FLT Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group."
388284|NCT00453362|O1|Outcome|Erlotinib_FLT Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
388285|NCT00453362|O2|Outcome|Erlotinib_ FLT Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who did not have CR/PR on FLT-PET scans at Day 56 were included in this group."
388286|NCT00453362|O1|Outcome|Erlotinib_FLT Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
388287|NCT00453362|O2|Outcome|Erlotinib_FDG Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group."
388288|NCT00453362|O1|Outcome|Erlotinib_FDG Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
388289|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
388290|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight no to exceed 15 mCi."
388291|NCT00453362|O2|Outcome|Erlotinib_ FDG Non-Responder|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group."
388292|NCT00453362|O1|Outcome|Erlotinib_FDG Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
388293|NCT00453362|O2|Outcome|Erlotinib_FLT Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group."
388294|NCT00453362|O1|Outcome|Erlotinib_FLT Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
388295|NCT00453362|O2|Outcome|Erlotinib_ FLT Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who did not have CR/PR on FLT-PET scans at Day 56 were included in this group."
388445|NCT00453999|B3|Baseline|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
388726|NCT00441766|B4|Baseline|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
388296|NCT00453362|O1|Outcome|Erlotinib_FLT Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
388297|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
388298|NCT00453362|O2|Outcome|Erlotinib_FDG Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group."
388299|NCT00453362|O1|Outcome|Erlotinib_FDG Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
388300|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi."
388301|NCT00453362|O2|Outcome|Erlotinib_ FDG Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group."
388302|NCT00453362|O1|Outcome|Erlotinib_FDG Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
388303|NCT00453362|E1|Reported Event|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
After 14 days and after 56 days of treatment with Erlotinib, participants underwent FDG-PET and FLT-PET scans. FDG-PET intravenous injection-dosage based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose of 7 mCi."
388304|NCT00453388|B5|Baseline|Total|Total of all reporting groups
388305|NCT00453388|B4|Baseline|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388306|NCT00453388|B3|Baseline|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388307|NCT00453388|B2|Baseline|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388308|NCT00453388|B1|Baseline|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388446|NCT00453999|B2|Baseline|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
388309|NCT00453388|P4|Participant Flow|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388310|NCT00453388|P3|Participant Flow|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388311|NCT00453388|P2|Participant Flow|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388312|NCT00453388|P1|Participant Flow|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388313|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388314|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388315|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388316|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388317|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
389664|NCT00456521|O2|Outcome|Placebo|Placebo
388318|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388319|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388320|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388321|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388322|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388323|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388324|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388325|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388326|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388727|NCT00441766|B3|Baseline|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
388327|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388328|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388329|NCT00453388|E4|Reported Event|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388330|NCT00453388|E3|Reported Event|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388331|NCT00453388|E2|Reported Event|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388332|NCT00453388|E1|Reported Event|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Total-Body Irradiation: Undergo TBI"
388333|NCT00453973|B3|Baseline|Pooled AF37702 Inj.|
388334|NCT00453973|B2|Baseline|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
388335|NCT00453973|B1|Baseline|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
388336|NCT00453973|P2|Participant Flow|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
388337|NCT00453973|P1|Participant Flow|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
388447|NCT00453999|B1|Baseline|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
388338|NCT00453973|O2|Outcome|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
388339|NCT00453973|O1|Outcome|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
388340|NCT00453973|E2|Reported Event|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
388341|NCT00453973|E1|Reported Event|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
388342|NCT00453986|B6|Baseline|Total|Total of all reporting groups
388343|NCT00453986|B5|Baseline|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388344|NCT00453986|B4|Baseline|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388345|NCT00453986|B3|Baseline|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388346|NCT00453986|B2|Baseline|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388347|NCT00453986|B1|Baseline|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388348|NCT00453986|P5|Participant Flow|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388349|NCT00453986|P4|Participant Flow|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388350|NCT00453986|P3|Participant Flow|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388351|NCT00453986|P2|Participant Flow|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388352|NCT00453986|P1|Participant Flow|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388353|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388354|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Group Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388355|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388356|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388357|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388358|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388359|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388360|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388361|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388728|NCT00441766|B2|Baseline|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
388366|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388367|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388368|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388369|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388370|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388371|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388372|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388373|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388374|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388375|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388376|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388377|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388378|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388379|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388380|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388381|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388382|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388383|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388384|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388385|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388386|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388387|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388388|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388389|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388390|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388448|NCT00453999|P3|Participant Flow|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
414803|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
388391|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388392|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388393|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388394|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388395|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388396|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388397|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388398|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388399|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388400|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388401|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388402|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388403|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388404|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388405|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388406|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388407|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388408|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388409|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388410|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388411|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388412|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388413|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388414|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388415|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388416|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388417|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388729|NCT00441766|B1|Baseline|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
388418|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388419|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388420|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388421|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388422|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388423|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388424|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388425|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388426|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388427|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388428|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388429|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388430|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388431|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388432|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388433|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388434|NCT00453986|O2|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of Fluarix vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388435|NCT00453986|O1|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388436|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388437|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388438|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388439|NCT00453986|E5|Reported Event|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388440|NCT00453986|E4|Reported Event|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388441|NCT00453986|E3|Reported Event|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
388442|NCT00453986|E2|Reported Event|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
388443|NCT00453986|E1|Reported Event|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
388444|NCT00453999|B4|Baseline|Total|Total of all reporting groups
388730|NCT00441766|P4|Participant Flow|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
388450|NCT00453999|P1|Participant Flow|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
388491|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388451|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
388452|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
388453|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
388454|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
388455|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
388456|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
388457|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
388458|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
388459|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
388460|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
388461|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
388462|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
388463|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
388464|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
388465|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
388466|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
388467|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
388468|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
388469|NCT00453999|E3|Reported Event|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
388470|NCT00453999|E2|Reported Event|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
388471|NCT00453999|E1|Reported Event|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
388472|NCT00454051|B3|Baseline|Total|Total of all reporting groups
388473|NCT00454051|B2|Baseline|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388474|NCT00454051|B1|Baseline|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388475|NCT00454051|P2|Participant Flow|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388476|NCT00454051|P1|Participant Flow|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388477|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388478|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388479|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388480|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388481|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388482|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388483|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388484|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388485|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388486|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388487|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388488|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388490|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388492|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388493|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388494|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388495|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388496|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388497|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388498|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388499|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388500|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388501|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388502|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388503|NCT00454051|E2|Reported Event|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
388504|NCT00454051|E1|Reported Event|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
388505|NCT00454116|B4|Baseline|Total|Total of all reporting groups
388506|NCT00454116|B3|Baseline|Placebo Plus FOLFIRI|placebo plus FOLFIRI
388507|NCT00454116|B2|Baseline|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
388508|NCT00454116|B1|Baseline|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
388509|NCT00454116|P3|Participant Flow|Placebo Plus FOLFIRI|placebo plus FOLFIRI
388510|NCT00454116|P2|Participant Flow|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
388511|NCT00454116|P1|Participant Flow|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
388512|NCT00454116|O3|Outcome|Placebo Plus FOLFIRI|placebo plus FOLFIRI
388513|NCT00454116|O2|Outcome|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
388514|NCT00454116|O1|Outcome|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
388515|NCT00454116|E3|Reported Event|Placebo Plus FOLFIRI|placebo plus FOLFIRI
388516|NCT00454116|E2|Reported Event|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
388517|NCT00454116|E1|Reported Event|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
388518|NCT00454142|B1|Baseline|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
computed tomography : Correlative studies
pharmacological study : Correlative studies
pazopanib hydrochloride : Given PO"
388519|NCT00454142|P1|Participant Flow|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
computed tomography : Correlative studies
pharmacological study : Correlative studies
pazopanib hydrochloride : Given PO"
388520|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
pharmacological study: Correlative studies
computed tomography: Correlative studies"
388521|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
pharmacological study: Correlative studies
computed tomography: Correlative studies"
388522|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
pharmacological study: Correlative studies
computed tomography: Correlative studies"
388523|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
pharmacological study: Correlative studies
computed tomography: Correlative studies"
388524|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
pharmacological study: Correlative studies
computed tomography: Correlative studies"
388525|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
pharmacological study: Correlative studies
computed tomography: Correlative studies"
388526|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
pharmacological study: Correlative studies
computed tomography: Correlative studies"
389665|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
388527|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
computed tomography : Correlative studies
pharmacological study : Correlative studies
pazopanib hydrochloride : Given PO"
388528|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
pharmacological study: Correlative studies
computed tomography: Correlative studies"
388529|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
computed tomography : Correlative studies
pharmacological study : Correlative studies
pazopanib hydrochloride : Given PO"
388530|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
computed tomography : Correlative studies
pharmacological study : Correlative studies
pazopanib hydrochloride : Given PO"
388531|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
pharmacological study: Correlative studies
computed tomography: Correlative studies"
388532|NCT00454142|E1|Reported Event|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
computed tomography : Correlative studies
pharmacological study : Correlative studies
pazopanib hydrochloride : Given PO"
388533|NCT00454181|B3|Baseline|Total|Total of all reporting groups
388534|NCT00454181|B2|Baseline|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
388535|NCT00454181|B1|Baseline|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
388536|NCT00454181|P2|Participant Flow|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
388537|NCT00454181|P1|Participant Flow|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
388538|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
388539|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
388540|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
388541|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
388542|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
388543|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
388544|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
388545|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
388546|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
388547|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
388548|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
388549|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
388550|NCT00454181|E2|Reported Event|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
388551|NCT00454181|E1|Reported Event|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
388552|NCT00454194|B3|Baseline|Total|Total of all reporting groups
388553|NCT00454194|B2|Baseline|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
388554|NCT00454194|B1|Baseline|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
388555|NCT00454194|P2|Participant Flow|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
388556|NCT00454194|P1|Participant Flow|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
388557|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
388558|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
388559|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
388560|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
388561|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
388562|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
388563|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
388564|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
388565|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
388566|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
388567|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
388568|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
388569|NCT00454194|E2|Reported Event|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
388570|NCT00454194|E1|Reported Event|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
388571|NCT00454207|B3|Baseline|Total|Total of all reporting groups
388687|NCT00454571|B2|Baseline|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
leuprolide acetate
goserelin acetate"
388737|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
388572|NCT00454207|B2|Baseline|Sildenafil: Participants Who Entered the Study From Part II|Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
388573|NCT00454207|B1|Baseline|Sildenafil: Participant Who Entered the Study From Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388574|NCT00454207|P2|Participant Flow|Sildenafil: Participants Who Entered the Study From Part II|Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
388575|NCT00454207|P1|Participant Flow|Sildenafil: Participant Who Entered the Study From Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388576|NCT00454207|O1|Outcome|Sildenafil: Part I and Part II|Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
388577|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388578|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388579|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388580|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388581|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388582|NCT00454207|O1|Outcome|Sildenafil:Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388583|NCT00454207|O1|Outcome|Sildenafil: Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388584|NCT00454207|O4|Outcome|Sildenafil: Part II, Functional Class at Baseline: IV|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were IV. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388585|NCT00454207|O3|Outcome|Sildenafil: Part II, Functional Class at Baseline: III|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were III. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388731|NCT00441766|P3|Participant Flow|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
388586|NCT00454207|O2|Outcome|Sildenafil:Part II, Functional Class at Baseline: II|Consists of participants who newly entered the study from Part II period in Week 0, and whose who functional class at baseline were II. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388587|NCT00454207|O1|Outcome|Sildenafil:Part II, Functional Class at Baseline: I|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were I. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388588|NCT00454207|O1|Outcome|Sildenafil:Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388589|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388590|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388591|NCT00454207|O4|Outcome|Sildenafil, Part I, Functional Class at Baseline:IV|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388592|NCT00454207|O3|Outcome|Sildenafil, Part I, Functional Class at Baseline: III|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388593|NCT00454207|O2|Outcome|Sildenafil:Part I, Functional Class at Baseline: II|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388594|NCT00454207|O1|Outcome|Sildenafil:Part I , Functional Class at Baseline: I|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were I. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388595|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388596|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388597|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388598|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388599|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388600|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388601|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388602|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388603|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388604|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388605|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388606|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388607|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388608|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388609|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388610|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388611|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388612|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388613|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388614|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388615|NCT00454207|O1|Outcome|Sildenafil: Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
388616|NCT00454207|E1|Reported Event|Sildenafil: Part I and Part II|Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
388617|NCT00454246|B4|Baseline|Total|Total of all reporting groups
388618|NCT00454246|B3|Baseline|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388619|NCT00454246|B2|Baseline|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388620|NCT00454246|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388621|NCT00454246|P3|Participant Flow|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388622|NCT00454246|P2|Participant Flow|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388623|NCT00454246|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388624|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388625|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388626|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388627|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388628|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388629|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388630|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388631|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388632|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388633|NCT00454246|E3|Reported Event|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388634|NCT00454246|E2|Reported Event|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388635|NCT00454246|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
388636|NCT00454324|B3|Baseline|Total|Total of all reporting groups
388637|NCT00454324|B2|Baseline|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388638|NCT00454324|B1|Baseline|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388639|NCT00454324|P2|Participant Flow|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
389666|NCT00456521|O2|Outcome|Placebo|Placebo
388640|NCT00454324|P1|Participant Flow|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of Area Under the Curve (AUC)=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388641|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388642|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388643|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388644|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388645|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388646|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388647|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388648|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388649|NCT00454324|E2|Reported Event|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388650|NCT00454324|E1|Reported Event|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles
Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle
Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
388651|NCT00454363|B3|Baseline|Total|Total of all reporting groups
388652|NCT00454363|B2|Baseline|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
388653|NCT00454363|B1|Baseline|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
388654|NCT00454363|P2|Participant Flow|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
388655|NCT00454363|P1|Participant Flow|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
388656|NCT00454363|O2|Outcome|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
388657|NCT00454363|O1|Outcome|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
388658|NCT00454363|O2|Outcome|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
388659|NCT00454363|O1|Outcome|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
388660|NCT00454363|E1|Reported Event|Pazopanib|Oral pazopanib hydrochloride once daily on days 1-28.
388661|NCT00454532|B5|Baseline|Total|Total of all reporting groups
388662|NCT00454532|B4|Baseline|Level 4|40g/day
388663|NCT00454532|B3|Baseline|Level 3|30g/day
388664|NCT00454532|B2|Baseline|Level 2|20g/day
388665|NCT00454532|B1|Baseline|Level 1|10g/day
388666|NCT00454532|P4|Participant Flow|Level 4|40g/day
388667|NCT00454532|P3|Participant Flow|Level 3|30g/day
388668|NCT00454532|P2|Participant Flow|Level 2|20g/day
388669|NCT00454532|P1|Participant Flow|Level 1|10g/day
388670|NCT00454532|O4|Outcome|Level 4|40g/day
388671|NCT00454532|O3|Outcome|Level 3|30g/day
388672|NCT00454532|O2|Outcome|Level 2|20g/day
388673|NCT00454532|O1|Outcome|Level 1|10g/day
388674|NCT00454532|O4|Outcome|Level 4|40g/day
388675|NCT00454532|O3|Outcome|Level 3|30g/day
388676|NCT00454532|O2|Outcome|Level 2|20g/day
388677|NCT00454532|O1|Outcome|Level 1|10g/day
388678|NCT00454532|O4|Outcome|Level 4|40g/day
388679|NCT00454532|O3|Outcome|Level 3|30g/day
388680|NCT00454532|O2|Outcome|Level 2|20g/day
388681|NCT00454532|O1|Outcome|Level 1|10g/day
388682|NCT00454532|E4|Reported Event|Level 4|40g/day
388683|NCT00454532|E3|Reported Event|Level 3|30g/day
388688|NCT00454571|B1|Baseline|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
leuprolide acetate
goserelin acetate"
388689|NCT00454571|P2|Participant Flow|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
leuprolide acetate
goserelin acetate"
388690|NCT00454571|P1|Participant Flow|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
leuprolide acetate
goserelin acetate"
388691|NCT00454571|O2|Outcome|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
leuprolide acetate
goserelin acetate"
388692|NCT00454571|O1|Outcome|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
leuprolide acetate
goserelin acetate"
388693|NCT00454571|O2|Outcome|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
leuprolide acetate
goserelin acetate"
388694|NCT00454571|O1|Outcome|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
leuprolide acetate
goserelin acetate"
388695|NCT00454571|E2|Reported Event|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
leuprolide acetate
goserelin acetate"
388696|NCT00454571|E1|Reported Event|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
leuprolide acetate
goserelin acetate"
388697|NCT00441727|B4|Baseline|Total|Total of all reporting groups
388698|NCT00441727|B3|Baseline|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
388699|NCT00441727|B2|Baseline|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
388700|NCT00441727|B1|Baseline|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388701|NCT00441727|P3|Participant Flow|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
388702|NCT00441727|P2|Participant Flow|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
388703|NCT00441727|P1|Participant Flow|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388704|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
388705|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
388706|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388707|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388708|NCT00441727|O2|Outcome|Esomeproazole 20 mg|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (acetylsalicyclic acid) (75-325 mg)
388709|NCT00441727|O1|Outcome|Esomeprazole 40 mg|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388710|NCT00441727|O3|Outcome|Placbo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388711|NCT00441727|O2|Outcome|Esomeprazole 20 mg|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388712|NCT00441727|O1|Outcome|Esomeprazole 40 mg|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388713|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
388714|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
388715|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388716|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
388717|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
388718|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388719|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
388720|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
388721|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388722|NCT00441727|E3|Reported Event|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
388723|NCT00441727|E2|Reported Event|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
388724|NCT00441727|E1|Reported Event|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
388732|NCT00441766|P2|Participant Flow|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
388733|NCT00441766|P1|Participant Flow|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
388738|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
388739|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
388740|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
388741|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
388742|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
388743|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
388744|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
388745|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
388746|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
388747|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
388748|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
388749|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
388750|NCT00441766|E4|Reported Event|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
388751|NCT00441766|E3|Reported Event|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
388752|NCT00441766|E2|Reported Event|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
388753|NCT00441766|E1|Reported Event|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
388754|NCT00441792|B3|Baseline|Total|Total of all reporting groups
388755|NCT00441792|B2|Baseline|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
388756|NCT00441792|B1|Baseline|Midazolam|Patients received either etomidate or midazolam.
388757|NCT00441792|P2|Participant Flow|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
388758|NCT00441792|P1|Participant Flow|Midazolam|Patients received either etomidate or midazolam.
388759|NCT00441792|O2|Outcome|Etomidate|Patients received etomidate (0.3 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
388760|NCT00441792|O1|Outcome|Midazolam|Patients received midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
388761|NCT00441792|O2|Outcome|Etomidate|Patients received etomidate (0.3 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
388803|NCT00447278|O1|Outcome|Pearson Correlation Coefficient|Correlation Coefficient between parent-rated and patient-rated CHIP T-score domains.
388804|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
389117|NCT00454779|P1|Participant Flow|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
388805|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
388806|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
388807|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
389121|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
388762|NCT00441792|O1|Outcome|Midazolam|Patients received midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
388763|NCT00441792|E2|Reported Event|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
388764|NCT00441792|E1|Reported Event|Midazolam|Patients received either etomidate or midazolam.
388765|NCT00447226|B1|Baseline|All Participants|All participants treated in the open-label phase (1500 milligrams [mg] lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
388766|NCT00447226|P2|Participant Flow|Lapatinib 1500 Milligrams (mg)|Lapatinib 1500 mg orally, once a day
388767|NCT00447226|P1|Participant Flow|Placebo|Identical matching placebo orally, once a day
388768|NCT00447226|O1|Outcome|All Screened Participants|All screened participants
388769|NCT00447226|O1|Outcome|Screened Participants With Gastric Cancer|Screened participants with gastric cancer
388770|NCT00447226|O1|Outcome|All Participants With Ovarian Cancer|All participants with ovarian cancer treated in the open-label phase (1500 mg lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
388771|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day: up to end of Stage 2
388772|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day: up to end of Stage 2
388773|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day: up to end of Stage 1
388774|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day
388775|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
388776|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day
388777|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day
388778|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
388779|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day
388780|NCT00447226|O2|Outcome|Placebo|Identical matching placebo orally, once a day
388781|NCT00447226|O1|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
388782|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 Milligrams (mg)|Open-label lapatinib 1500 mg orally, once a day
388783|NCT00447226|E1|Reported Event|All Participants|All participants treated in the open-label phase (1500 mg lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
388784|NCT00447265|B1|Baseline|Etanercept|Participant self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks. She continued receiving her usual treatment with corticosteroids and mycophenolate mofetil.
388785|NCT00447265|P2|Participant Flow|Placebo|Participants (or their caretaker) would administer 50 mg placebo subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.
388786|NCT00447265|P1|Participant Flow|Etanercept|Participants (or their caretaker) would administer 50 mg etanercept subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.
388787|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
388788|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
388789|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
388790|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
388791|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
388792|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
388793|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
388794|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
388795|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
388796|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
388797|NCT00447265|E1|Reported Event|Etanercept|Participant received self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks while continuing to receive her usual lupus treatment of corticosteroids and mycophenolate mofetil.
388798|NCT00447278|B3|Baseline|Total|Total of all reporting groups
388799|NCT00447278|B2|Baseline|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
388800|NCT00447278|B1|Baseline|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
388801|NCT00447278|P2|Participant Flow|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
388802|NCT00447278|P1|Participant Flow|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
414804|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
388808|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
388809|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
388810|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
388811|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
388812|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
388813|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
388814|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
388815|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
388816|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
388817|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
388818|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
388819|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
388820|NCT00447278|E2|Reported Event|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
388821|NCT00447278|E1|Reported Event|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
388822|NCT00447330|B1|Baseline|1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
388823|NCT00447330|P1|Participant Flow|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
388824|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
388825|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
388826|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
388827|NCT00447330|O1|Outcome|1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
388854|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
414805|NCT00524745|E4|Reported Event|Standard (0,2,6 Month) Schedule|
388828|NCT00447330|E1|Reported Event|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
388830|NCT00447382|B2|Baseline|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388831|NCT00447382|B1|Baseline|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388832|NCT00447382|P2|Participant Flow|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388833|NCT00447382|P1|Participant Flow|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388834|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388835|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388836|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388837|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388838|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388839|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388840|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388841|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388842|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388843|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388844|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388845|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388846|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388847|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388848|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388849|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388850|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388851|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388852|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388853|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388855|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388856|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
389122|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
388857|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388858|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388859|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388860|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388861|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388862|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388863|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388864|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388865|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388866|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388867|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388868|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388869|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388870|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388871|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388872|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388873|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388874|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388875|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388876|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388877|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388878|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388879|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388880|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
389118|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
388881|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388882|NCT00447382|E2|Reported Event|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388883|NCT00447382|E1|Reported Event|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
388884|NCT00447421|B1|Baseline|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
388885|NCT00447421|P1|Participant Flow|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
388886|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
388887|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
388888|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
388889|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
388890|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
388891|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
388892|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
388893|NCT00447421|E1|Reported Event|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
388894|NCT00447499|B1|Baseline|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
388895|NCT00447499|P1|Participant Flow|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
388896|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
388897|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
388898|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
388899|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)|Somatuline Autogel (lanreotide acetate) Injection/Switch Patient
388900|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)/Switch Patient|
388901|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)/Switch Patient|
388902|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
388903|NCT00447499|E1|Reported Event|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
388904|NCT00454584|B4|Baseline|Total|Total of all reporting groups
388905|NCT00454584|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388906|NCT00454584|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388907|NCT00454584|B1|Baseline|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
389123|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
388908|NCT00454584|P6|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40.
388909|NCT00454584|P5|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40.
388910|NCT00454584|P4|Participant Flow|Etanercept (After CP)|After Controlled period (Week 12- 64) – receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40
388911|NCT00454584|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
388912|NCT00454584|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
388913|NCT00454584|P1|Participant Flow|Etanercept (CP)|Controlled period (Week 0-12) - Etanercept group
388914|NCT00454584|O2|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388915|NCT00454584|O1|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388916|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388917|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388918|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388919|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388920|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388921|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388922|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388923|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388924|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
388925|NCT00454584|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40.
388926|NCT00454584|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40.
388927|NCT00454584|E5|Reported Event|Etanercept -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg upon becoming a nonresponder during Week 12 and Week 40. This group is a subpopulation of Etanercept (after CP).
388928|NCT00454584|E4|Reported Event|Etanercept (After CP)|After Controlled period (Week 12-64) – receiving etanercept at Weeks 0 -> prior to being treated with ustekinumab
388929|NCT00454584|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
388930|NCT00454584|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
388931|NCT00454584|E1|Reported Event|Etanercept (CP)|Controlled period (Week 0-12) - Etanercept group
388932|NCT00454636|B5|Baseline|Total|Total of all reporting groups
388933|NCT00454636|B4|Baseline|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
388934|NCT00454636|B3|Baseline|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
389124|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
388935|NCT00454636|B2|Baseline|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388936|NCT00454636|B1|Baseline|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
388937|NCT00454636|P4|Participant Flow|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
388938|NCT00454636|P3|Participant Flow|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388939|NCT00454636|P2|Participant Flow|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388940|NCT00454636|P1|Participant Flow|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
388941|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
388942|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388943|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388944|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
388945|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
388946|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388947|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388948|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
388949|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
388950|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388951|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388952|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
388953|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
388954|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388955|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388956|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
388957|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
388958|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
389017|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
414806|NCT00524745|E3|Reported Event|0,12,24 Month Schedule|
388959|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388960|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
388961|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
388962|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388963|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388964|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
388965|NCT00454636|E4|Reported Event|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
388966|NCT00454636|E3|Reported Event|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388967|NCT00454636|E2|Reported Event|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
388968|NCT00454636|E1|Reported Event|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
388969|NCT00454649|B11|Baseline|Total|Total of all reporting groups
388970|NCT00454649|B10|Baseline|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
388971|NCT00454649|B9|Baseline|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
388972|NCT00454649|B8|Baseline|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
388973|NCT00454649|B7|Baseline|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
388974|NCT00454649|B6|Baseline|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
388975|NCT00454649|B5|Baseline|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
388976|NCT00454649|B4|Baseline|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
388977|NCT00454649|B3|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
388978|NCT00454649|B2|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
388979|NCT00454649|B1|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
389018|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
389125|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389126|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
442812|NCT00594425|E3|Reported Event|Vehicle PDT|
388980|NCT00454649|P10|Participant Flow|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
388981|NCT00454649|P9|Participant Flow|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
388982|NCT00454649|P8|Participant Flow|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
388983|NCT00454649|P7|Participant Flow|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
388984|NCT00454649|P6|Participant Flow|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
388985|NCT00454649|P5|Participant Flow|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
388986|NCT00454649|P4|Participant Flow|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
388987|NCT00454649|P3|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
388988|NCT00454649|P2|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
388989|NCT00454649|P1|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
388990|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
388991|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 18 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
388992|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
388993|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
388994|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
388995|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
388996|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389019|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
388997|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
388998|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/meter square (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
388999|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389000|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389001|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389002|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389003|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389004|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389005|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389006|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389007|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389008|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389009|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389010|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389011|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389012|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389013|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389014|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
389015|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
389016|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
389119|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389020|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389021|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389022|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389023|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389024|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389025|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389026|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389027|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389028|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389029|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389030|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389031|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389032|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389033|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389034|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
389035|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
389036|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
389037|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
389038|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
389039|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
389040|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
389041|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
389042|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
389043|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
389044|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
389045|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
389046|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
389047|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
389048|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
389049|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389050|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389051|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389052|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389053|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
389054|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
389055|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389056|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389057|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
389058|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389059|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389060|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389061|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389062|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
414807|NCT00524745|E2|Reported Event|0,6,12 Month Schedule|
389063|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
389064|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389065|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389066|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
389067|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389068|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389069|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389070|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389071|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
389072|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
389073|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389074|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389075|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
389076|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389077|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389078|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389079|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389096|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389080|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
389081|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
389082|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389083|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389084|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
389085|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 administered as infusion on Day 1 Cycle 1 and all subsequent cycles.
389086|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval. Cisplatin 80 mg/m^2 administered as infusion on Day 1 of Cycle 1 and all subsequent cycles. Gemcitabine 1250 mg/m^2 administered as infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles.
389087|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1250 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
389088|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1000 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
389089|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1. AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Docetaxel 100 mg/m^2 administered as 60-minute infusion on Day 1 of every cycle.
389090|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 25 of Cycle 1 (cycle length 28 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel 90 mg/m^2 administered as 60-minute infusion on Day 1, 8, and 15 of every cycle.
389091|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
389092|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|AG-013736 3 oral tablets of 1 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
389093|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) oral tablet of 1 mg (milligram) administered twice daily (BID) as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
389094|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389095|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389097|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389098|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
389099|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
389100|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389101|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389102|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
389103|NCT00454649|E10|Reported Event|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
389104|NCT00454649|E9|Reported Event|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
389105|NCT00454649|E8|Reported Event|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389106|NCT00454649|E7|Reported Event|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
389107|NCT00454649|E6|Reported Event|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
389108|NCT00454649|E5|Reported Event|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389109|NCT00454649|E4|Reported Event|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
389110|NCT00454649|E3|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389111|NCT00454649|E2|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
389112|NCT00454649|E1|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
389113|NCT00454779|B3|Baseline|Total|Total of all reporting groups
389114|NCT00454779|B2|Baseline|Chemotherapy Alone|Docetaxel + Cisplatin, control
389115|NCT00454779|B1|Baseline|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389116|NCT00454779|P2|Participant Flow|Chemotherapy Alone|Docetaxel + Cisplatin, control
389127|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389128|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
389129|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389130|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
389131|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389132|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
389133|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389134|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
389135|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389136|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
389137|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389138|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
389139|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389140|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
389141|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389142|NCT00454779|E2|Reported Event|Chemotherapy Alone|Docetaxel + Cisplatin, control
389143|NCT00454779|E1|Reported Event|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
389144|NCT00454805|B3|Baseline|Total|Total of all reporting groups
389145|NCT00454805|B2|Baseline|Placebo|"Placebo+Fulvestrant 250 mg
Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: placebo to match cediranib (administered orally)"
389146|NCT00454805|B1|Baseline|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg
Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: cediranib 45 mg (administered orally)"
389147|NCT00454805|P2|Participant Flow|Placebo|"Placebo+Fulvestrant 250 mg
Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: placebo to match cediranib (administered orally)"
389148|NCT00454805|P1|Participant Flow|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg
Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: cediranib 45 mg (administered orally)"
389149|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg
Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: placebo to match cediranib (administered orally)"
389150|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg
Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: cediranib 45 mg (administered orally)"
389151|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg
Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: placebo to match cediranib (administered orally)"
389152|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg
Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: cediranib 45 mg (administered orally)"
389153|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg
Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: placebo to match cediranib (administered orally)"
389154|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg
Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: cediranib 45 mg (administered orally)"
389155|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg
Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: placebo to match cediranib (administered orally)"
389156|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg
Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: cediranib 45 mg (administered orally)"
389209|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389237|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389157|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg
Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: placebo to match cediranib (administered orally)"
389183|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389158|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg
Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: cediranib 45 mg (administered orally)"
389159|NCT00454805|E2|Reported Event|Placebo|"Placebo+Fulvestrant 250 mg
Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: placebo to match cediranib (administered orally)"
389160|NCT00454805|E1|Reported Event|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg
Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:
Day 1: fulvestrant 500 mg im
Day 15: fulvestrant 250 mg im
Day 29, and every 28 days thereafter: fulvestrant 250 mg im
and daily: cediranib 45 mg (administered orally)"
389161|NCT00454818|B9|Baseline|Total|Total of all reporting groups
389162|NCT00454818|B8|Baseline|Phase 2: Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389163|NCT00454818|B7|Baseline|Phase 2: MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389164|NCT00454818|B6|Baseline|Phase 2: MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389165|NCT00454818|B5|Baseline|Phase 2: MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389166|NCT00454818|B4|Baseline|Phase 1: MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389167|NCT00454818|B3|Baseline|Phase 1: MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389168|NCT00454818|B2|Baseline|Phase 1: MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389169|NCT00454818|B1|Baseline|Phase 1: MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.
389170|NCT00454818|P5|Participant Flow|Placebo|"Single dose of placebo administered by antegrade epicardial coronary artery infusion.
The placebo arm was included only in the Phase 2 randomized double-blind period."
389171|NCT00454818|P4|Participant Flow|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
389172|NCT00454818|P3|Participant Flow|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
389173|NCT00454818|P2|Participant Flow|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
389174|NCT00454818|P1|Participant Flow|MYDICAR® Very Low Dose|"Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
This arm was included only in the Phase I open-label dose-escalation period."
389175|NCT00454818|O6|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389176|NCT00454818|O5|Outcome|All MYDICAR®|All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.
389177|NCT00454818|O4|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389178|NCT00454818|O3|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389179|NCT00454818|O2|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389180|NCT00454818|O1|Outcome|MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.
389181|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389667|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389182|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
442813|NCT00594425|E2|Reported Event|80 mg/g MAL PDT|
389184|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389185|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389186|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389187|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389188|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389189|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389190|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389191|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389192|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389193|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389194|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389195|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389196|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389197|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389198|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389199|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389200|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389201|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389202|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389203|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389204|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389205|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389206|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389207|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389208|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389210|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389211|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389212|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389213|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389214|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389215|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389216|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389217|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389218|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389219|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389220|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389221|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389222|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389223|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389224|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389225|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389226|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389227|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389228|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389229|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389230|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389231|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389232|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389233|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389234|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389235|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389236|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389238|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389239|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389240|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389241|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389242|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389243|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389244|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
389245|NCT00454818|E5|Reported Event|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
389246|NCT00454818|E4|Reported Event|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
389247|NCT00454818|E3|Reported Event|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
389248|NCT00454818|E2|Reported Event|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11DRP administered by antegrade epicardial coronary artery infusion.
389249|NCT00454818|E1|Reported Event|MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11DRP administered by antegrade epicardial coronary artery infusion.
389250|NCT00454857|B1|Baseline|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389251|NCT00454857|P1|Participant Flow|Patients With ITP|Patients diagnosed with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) were followed prospectively for a period of 12 months.
389252|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389253|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389254|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389255|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389256|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389257|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389258|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389259|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389260|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389261|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389262|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389263|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389264|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389265|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
389266|NCT00454857|E1|Reported Event|Overall Study|
389267|NCT00454909|B4|Baseline|Total|Total of all reporting groups
389268|NCT00454909|B3|Baseline|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389269|NCT00454909|B2|Baseline|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389270|NCT00454909|B1|Baseline|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389271|NCT00454909|P3|Participant Flow|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389272|NCT00454909|P2|Participant Flow|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389273|NCT00454909|P1|Participant Flow|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389668|NCT00456521|O2|Outcome|Placebo|Placebo
389274|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389275|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389377|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389276|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389277|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389278|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389279|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389280|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389281|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389282|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389283|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389284|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389285|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389286|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389287|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received on dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389288|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389289|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389290|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389291|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389292|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389293|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389294|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389295|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389296|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389297|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389298|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389299|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389300|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389301|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389302|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received on dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389303|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389304|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389305|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
414808|NCT00524745|E1|Reported Event|0,3,9 Month Schedule|
389306|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389307|NCT00454909|E3|Reported Event|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389308|NCT00454909|E2|Reported Event|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389309|NCT00454909|E1|Reported Event|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
389310|NCT00455195|B3|Baseline|Total|Total of all reporting groups
389311|NCT00455195|B2|Baseline|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
389312|NCT00455195|B1|Baseline|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389313|NCT00455195|P2|Participant Flow|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
389314|NCT00455195|P1|Participant Flow|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389315|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389316|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389317|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389318|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389319|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389320|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389321|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389322|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389323|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389324|NCT00455195|E3|Reported Event|Overall|The combined alglucosidase alfa treatment experience from the two treatment groups.
389325|NCT00455195|E2|Reported Event|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double-blind study, started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
389326|NCT00455195|E1|Reported Event|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
389327|NCT00455312|B3|Baseline|Total|Total of all reporting groups
389328|NCT00455312|B2|Baseline|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389368|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389669|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389378|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389379|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389380|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
442814|NCT00594425|E1|Reported Event|40 mg/g MAL PDT|
389329|NCT00455312|B1|Baseline|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389330|NCT00455312|P2|Participant Flow|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin (ATG), total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389331|NCT00455312|P1|Participant Flow|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389332|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389333|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389334|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389335|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389336|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389337|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389369|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389370|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389371|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389372|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389338|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389339|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389340|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389341|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389342|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389343|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389344|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389345|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389346|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389373|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389374|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389375|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389376|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389347|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389348|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389349|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389350|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389351|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389352|NCT00455312|E2|Reported Event|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0.
antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.
Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
389353|NCT00455312|E1|Reported Event|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.
Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given
Stem Cell Transplantation: Infusion of stem cells on Day 0."
389354|NCT00455429|B5|Baseline|Total|Total of all reporting groups
389355|NCT00455429|B4|Baseline|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389356|NCT00455429|B3|Baseline|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389357|NCT00455429|B2|Baseline|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389358|NCT00455429|B1|Baseline|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389359|NCT00455429|P4|Participant Flow|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389360|NCT00455429|P3|Participant Flow|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389361|NCT00455429|P2|Participant Flow|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389362|NCT00455429|P1|Participant Flow|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389363|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389364|NCT00455429|O2|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389365|NCT00455429|O1|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389366|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389367|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389564|NCT00455702|B1|Baseline|D-cycloserine|50 mg d-cycloserine
389381|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389382|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389383|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389384|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389385|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389386|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389387|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389388|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389389|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389390|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389391|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389392|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389393|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389394|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389395|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389396|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389397|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389398|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389399|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389400|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389401|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389402|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389403|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389404|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389405|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389406|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389407|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389408|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389409|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389410|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389411|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389412|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389413|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389414|NCT00455429|E4|Reported Event|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
389415|NCT00455429|E3|Reported Event|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
389416|NCT00455429|E2|Reported Event|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
389417|NCT00455429|E1|Reported Event|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
389418|NCT00455455|B1|Baseline|Entire Study Group|includes groups randomized to use RepleniSH in the 1st period and ReNu in the 2nd period, and first use ReNu and use RepleniSH in the second period.
389419|NCT00455455|P2|Participant Flow|ReNu First, Then RepleniSH|Following a washout period, use ReNu for lens care in first period and RepleniSH in second period (after the second washout period)
389420|NCT00455455|P1|Participant Flow|RepleniSH First, Then ReNu|Following a washout period, use RepleniSH for lens care in first period and ReNu in second period (after the second washout period)
389421|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in the first period or the second period
389422|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in the first period and the second period
389423|NCT00455455|O2|Outcome|ReNu|Use ReNu for lens care in either first period or second period
389424|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
389425|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
389426|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
389427|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
389428|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
389429|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
389430|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
389431|NCT00455455|O2|Outcome|ReNu|Use ReNu for lens care in either first period or second period
389432|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
389433|NCT00455455|E2|Reported Event|ReNu|use ReNu for lens care in either first period or second period
389434|NCT00455455|E1|Reported Event|RepleniSH|use RepleniSH for lens care in either first period or second period
389435|NCT00455520|B3|Baseline|Total|Total of all reporting groups
389436|NCT00455520|B2|Baseline|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
389437|NCT00455520|B1|Baseline|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
389438|NCT00455520|P2|Participant Flow|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
389439|NCT00455520|P1|Participant Flow|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
389440|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
389441|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
389442|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
389443|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
389444|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
389445|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
389446|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
389447|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
389448|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
389449|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
389450|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
389451|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
389452|NCT00455520|E2|Reported Event|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
389453|NCT00455520|E1|Reported Event|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
389454|NCT00455533|B3|Baseline|Total|Total of all reporting groups
389455|NCT00455533|B2|Baseline|Paclitaxel (Randomized Population)|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389456|NCT00455533|B1|Baseline|Ixabepilone (Randomized Population)|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389457|NCT00455533|P3|Participant Flow|Paclitaxel|Paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389458|NCT00455533|P2|Participant Flow|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389459|NCT00455533|P1|Participant Flow|Doxorubicin / Cyclophosphamide (AC)|60 mg/m^2 doxorubicin and 600 mg/m^2 cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks).
389460|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389461|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389462|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389463|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389464|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389465|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389466|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389467|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389468|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389469|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389470|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389471|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389472|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389473|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389474|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389475|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389476|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389572|NCT00455702|E1|Reported Event|D-cycloserine|50 mg d-cycloserine
389477|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389478|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389479|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389480|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389481|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389482|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389483|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389484|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389485|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389486|NCT00455533|O1|Outcome|Randomized Participants|Randomized Participants with non-missing pCR and biomarker expression
389487|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389488|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389489|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389490|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389491|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389492|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389493|NCT00455533|O1|Outcome|Randomized Participants|
389494|NCT00455533|O1|Outcome|Randomized Participants|
389495|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389496|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389497|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389498|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389499|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389500|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389501|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389502|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389503|NCT00455533|E2|Reported Event|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
389504|NCT00455533|E1|Reported Event|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
389505|NCT00455650|B3|Baseline|Total|Total of all reporting groups
389506|NCT00455650|B2|Baseline|Control|Healthy volunteers were recruited through media advertisements in the greater Boston area and had no lifetime history of Axis I disorders by SCID interview and no firstdegree relatives with Axis I disorders by history
389507|NCT00455650|B1|Baseline|Schizophrenia|Study participants in the schizophrenia group were clinically stable, outpatient, non-smokers with schizophrenia on a stable, clinically determined dose of antipsychotic medication for at least 4 weeks, which were recruited from an urban community mental health clinic in Boston. Diagnoses were confirmed by clinical interview and medical record review
389508|NCT00455650|P6|Participant Flow|Control: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
389509|NCT00455650|P5|Participant Flow|Control: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389510|NCT00455650|P4|Participant Flow|Control: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389511|NCT00455650|P3|Participant Flow|Schizoph: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
389512|NCT00455650|P2|Participant Flow|Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389513|NCT00455650|P1|Participant Flow|Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389671|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389514|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
389515|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389516|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389517|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
389518|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389519|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389520|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
389521|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389522|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389523|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
389524|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389525|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389526|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
389527|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389528|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389529|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
389530|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389565|NCT00455702|P2|Participant Flow|Placebo|50 mg placebo
389531|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389672|NCT00456521|O2|Outcome|Placebo|Placebo
389532|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
389533|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389534|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389535|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
389536|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389537|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
389538|NCT00455650|E2|Reported Event|Control|Healthy volunteers were recruited through media advertisements in the greater Boston area and had no lifetime history of Axis I disorders by SCID interview and no firstdegree relatives with Axis I disorders by history
389539|NCT00455650|E1|Reported Event|Schizophrenia|Study participants in the schizophrenia group were clinically stable, outpatient, non-smokers with schizophrenia on a stable, clinically determined dose of antipsychotic medication for at least 4 weeks, which were recruited from an urban community mental health clinic in Boston. Diagnoses were confirmed by clinical interview and medical record review
389540|NCT00455663|B4|Baseline|Total|Total of all reporting groups
389541|NCT00455663|B3|Baseline|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
389542|NCT00455663|B2|Baseline|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
389543|NCT00455663|B1|Baseline|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
389544|NCT00455663|P3|Participant Flow|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
389545|NCT00455663|P2|Participant Flow|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
389546|NCT00455663|P1|Participant Flow|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
389547|NCT00455663|O3|Outcome|Treatment as Usual|Medication management and case management at a community mental health center
389548|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
389549|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
389550|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management at a community mental health center
389551|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
389552|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
389553|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management at a community mental health center
389554|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
389555|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
389556|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management in the community mental health center
389557|NCT00455663|O2|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
389558|NCT00455663|O1|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports to assist in medication and appointment adherence
389559|NCT00455663|E3|Reported Event|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
389560|NCT00455663|E2|Reported Event|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
389561|NCT00455663|E1|Reported Event|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
389562|NCT00455702|B3|Baseline|Total|Total of all reporting groups
389563|NCT00455702|B2|Baseline|Placebo|50 mg placebo
389568|NCT00455702|O1|Outcome|D-cycloserine|"50 mg d-cycloserine
d-cycloserine: 50mg dose d-cycloserine v placebo"
389569|NCT00455702|O2|Outcome|Placebo|50 mg placebo
389570|NCT00455702|O1|Outcome|D-cycloserine|50 mg d-cycloserine
389571|NCT00455702|E2|Reported Event|Placebo|50 mg placebo
389573|NCT00455858|B1|Baseline|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
389574|NCT00455858|P1|Participant Flow|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
389575|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
389576|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
389577|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
389578|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
389579|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
389580|NCT00455858|E1|Reported Event|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
389581|NCT00455962|B3|Baseline|Total|Total of all reporting groups
389582|NCT00455962|B2|Baseline|Caucasian Women|"Healthy Caucasian women 18-35 years old
Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr
Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
389583|NCT00455962|B1|Baseline|African American Women|"Healthy African-American women 18-35 years old
Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr
Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
389584|NCT00455962|P2|Participant Flow|Caucasian Women|"Healthy Caucasian women 18-35 years old
Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr
Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
389585|NCT00455962|P1|Participant Flow|African American Women|"Healthy African-American women 18-35 years old
Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr
Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
389586|NCT00455962|O2|Outcome|Caucasian Women|"Healthy Caucasian women 18-35 years old
Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr
Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
389587|NCT00455962|O1|Outcome|African American Women|"Healthy African-American women 18-35 years old
Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr
Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
389588|NCT00455962|E2|Reported Event|Caucasian Women|"Healthy Caucasian women 18-35 years old
Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr
Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
389589|NCT00455962|E1|Reported Event|African American Women|"Healthy African-American women 18-35 years old
Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr
Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
389590|NCT00455975|B3|Baseline|Total|Total of all reporting groups
389591|NCT00455975|B2|Baseline|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389592|NCT00455975|B1|Baseline|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389593|NCT00455975|P2|Participant Flow|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389594|NCT00455975|P1|Participant Flow|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389595|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389596|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389597|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389598|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389599|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389600|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389601|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389602|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389603|NCT00455975|E2|Reported Event|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389604|NCT00455975|E1|Reported Event|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Bevacizumab: Bevacizumab"
389605|NCT00456014|B1|Baseline|SSRI|The single arm of this study involves patients with current MDD who will all receive open standardized treatment with escitalopram. There are not multiple arms nor multiple patient groups.
389606|NCT00456014|P1|Participant Flow|Open Standardized Treatment|"Participants will take escitalopram through standardized dosing over an 8 week trial. Non-remitters will be offered entry into a second open treatment phase with standardized treatment with desipramine.
In phase 1, participants will receive escitalopram beginning at 10mg daily for 4 weeks, increasing to 20mg if non-response at week 4 or 6. If participants experience intolerable side-effects, they will be switched to an alternative SSRI, sertraline. Non-remitters after 8 weeks may enter a second phase of standardized treatment, switching from escitalopram to desipramine, dosed by blood level according to a treatment protocol. Those with intolerable side-effects to desipramine will be switched to an alternative tricyclic antidepressant, nortriptyline."
389607|NCT00456014|O1|Outcome|1 - SSRI|Participants will complete an 8-week trial of the SSRI escitalopram, or, if not tolerated, an 8-week trial of the SSRI sertraline.
389608|NCT00456014|O1|Outcome|Tricyclic Group|7 participants who did not remit during the SSRI phase advanced to the tricyclic phase. 4 participants completed this phase.
389609|NCT00456014|O1|Outcome|1 - SSRI|Participants will take escitalopram.
389610|NCT00456014|E1|Reported Event|1 - SSRI|Participants will take escitalopram.
389611|NCT00456261|B3|Baseline|Total|Total of all reporting groups
389612|NCT00456261|B2|Baseline|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
389613|NCT00456261|B1|Baseline|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
389614|NCT00456261|P2|Participant Flow|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
389615|NCT00456261|P1|Participant Flow|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
389616|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
389617|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
389618|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
389619|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
389670|NCT00456521|O2|Outcome|Placebo|Placebo
389673|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389674|NCT00456521|O2|Outcome|Placebo|Placebo
389675|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389676|NCT00456521|E2|Reported Event|Placebo|Placebo
389677|NCT00456521|E1|Reported Event|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389678|NCT00456547|B3|Baseline|Total|Total of all reporting groups
389620|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
389621|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
389622|NCT00456261|E2|Reported Event|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
389623|NCT00456261|E1|Reported Event|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
389624|NCT00456495|B1|Baseline|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
389625|NCT00456495|P1|Participant Flow|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
389626|NCT00456495|O1|Outcome|Open Label Treatment|Patients will receive treatment every 2-4 weeks. To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate the number of clock hours of corneal neovascularization, from baseline to month 12, and 24. To report on the number of patients with a decrease in corneal neovascularization.
389627|NCT00456495|O1|Outcome|Open Label Treatment|Patients will receive treatment every 2-4 weeks
389628|NCT00456495|E1|Reported Event|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
389629|NCT00456508|B1|Baseline|Treatment|DX-88 (ecallantide)
389630|NCT00456508|P1|Participant Flow|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
389631|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
389632|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
389633|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
389634|NCT00456508|E1|Reported Event|Treatment|DX-88 (ecallantide)
389635|NCT00456521|B3|Baseline|Total|Total of all reporting groups
389636|NCT00456521|B2|Baseline|Placebo|Placebo
389637|NCT00456521|B1|Baseline|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389638|NCT00456521|P2|Participant Flow|Placebo|Placebo
389639|NCT00456521|P1|Participant Flow|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389640|NCT00456521|O2|Outcome|Placebo|Placebo
389641|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389642|NCT00456521|O2|Outcome|Placebo|Placebo
389643|NCT00456521|O1|Outcome|NB32|"Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group behavioral lifestyle modification counseling
naltrexone SR/bupropion SR combination
Intensive group lifestyle modification counseling: Group lifestyle modification counseling"
389644|NCT00456521|O2|Outcome|Placebo|Placebo
389645|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389646|NCT00456521|O2|Outcome|Placebo|Placebo
389647|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389648|NCT00456521|O2|Outcome|Placebo|Placebo
389649|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389650|NCT00456521|O2|Outcome|Placebo|Placebo
389651|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389652|NCT00456521|O2|Outcome|Placebo|Placebo
389653|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389654|NCT00456521|O2|Outcome|Placebo|Placebo
389655|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389656|NCT00456521|O2|Outcome|Placebo|Placebo
389657|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389658|NCT00456521|O2|Outcome|Placebo|Placebo
389659|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389660|NCT00456521|O2|Outcome|Placebo|Placebo
389661|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
389662|NCT00456521|O2|Outcome|Placebo|Placebo
389679|NCT00456547|B2|Baseline|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
389680|NCT00456547|B1|Baseline|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
389681|NCT00456547|P2|Participant Flow|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
389682|NCT00456547|P1|Participant Flow|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
389683|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
389684|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
389685|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
389686|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
389687|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
389688|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
389689|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
389690|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
389691|NCT00456547|E2|Reported Event|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
389692|NCT00456547|E1|Reported Event|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
389693|NCT00456599|B1|Baseline|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
389694|NCT00456599|P1|Participant Flow|Gemcitabine and Oxaliplatin With Radiation Therapy|Gemcitabine and Oxaliplatin with radiation therapy in localized pancreatic cancer.
389695|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
389696|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
389697|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
389698|NCT00456599|E1|Reported Event|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
389699|NCT00456612|B1|Baseline|Single Arm|Single arm Phase II Study
389700|NCT00456612|P1|Participant Flow|Cyberknife|Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
389701|NCT00456612|O1|Outcome|Single Arm|Single arm Phase II Study
389702|NCT00456612|O1|Outcome|Cyberknife|"Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
CyberKnife: Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses."
389703|NCT00456612|E1|Reported Event|Single Arm Study|Single arm Phase II Study
389704|NCT00456625|B1|Baseline|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
389705|NCT00456625|P1|Participant Flow|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
389706|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
389707|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
389708|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
390070|NCT00450749|B3|Baseline|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
389709|NCT00456625|E1|Reported Event|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
389710|NCT00456755|B3|Baseline|Total|Total of all reporting groups
389711|NCT00456755|B2|Baseline|Placebo|The placebo contained brown colored starch resembling the SBL powder
389747|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389712|NCT00456755|B1|Baseline|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
389713|NCT00456755|P2|Participant Flow|Placebo|The placebo contained brown colored starch resembling the SBL powder
389714|NCT00456755|P1|Participant Flow|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
389715|NCT00456755|O2|Outcome|Placebo|The placebo contained brown colored starch resembling the SBL powder
389716|NCT00456755|O1|Outcome|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
389717|NCT00456755|O2|Outcome|Placebo|The placebo contained brown colored starch resembling the SBL powder
389718|NCT00456755|O1|Outcome|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
389719|NCT00456755|E2|Reported Event|Placebo|The placebo contained brown colored starch resembling the SBL powder
389720|NCT00456755|E1|Reported Event|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
389721|NCT00456807|B3|Baseline|Total|Total of all reporting groups
389722|NCT00456807|B2|Baseline|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
389723|NCT00456807|B1|Baseline|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
389724|NCT00456807|P2|Participant Flow|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
389725|NCT00456807|P1|Participant Flow|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
389726|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
389727|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
389728|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
389729|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
389730|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
389731|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
389732|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
389733|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
389734|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
389735|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
389736|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
389737|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
389738|NCT00456807|E2|Reported Event|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
389739|NCT00456807|E1|Reported Event|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
389740|NCT00456846|B3|Baseline|Total|Total of all reporting groups
389741|NCT00456846|B2|Baseline|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389742|NCT00456846|B1|Baseline|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389743|NCT00456846|P2|Participant Flow|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
389744|NCT00456846|P1|Participant Flow|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
389745|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389798|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389746|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
390073|NCT00450749|P3|Participant Flow|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
389748|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389749|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389750|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389751|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389752|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389753|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389754|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389755|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389756|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389757|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389758|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389759|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389760|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389761|NCT00456846|E2|Reported Event|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389762|NCT00456846|E1|Reported Event|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
389763|NCT00456989|B1|Baseline|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.
Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.
Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
389764|NCT00456989|P1|Participant Flow|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.
Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.
Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
389765|NCT00456989|O1|Outcome|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.
Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.
Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
389799|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
414809|NCT00524771|B3|Baseline|Total|Total of all reporting groups
389800|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389801|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
444933|NCT00591565|B1|Baseline|Acamprosate|acamprosate tablets
389766|NCT00456989|E1|Reported Event|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.
Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.
Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
389767|NCT00457002|B3|Baseline|Total|Total of all reporting groups
389768|NCT00457002|B2|Baseline|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389769|NCT00457002|B1|Baseline|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389770|NCT00457002|P2|Participant Flow|Enoxaparin 40 mg Subcutaneous|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389771|NCT00457002|P1|Participant Flow|Apixaban 2.5 mg Oral|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389772|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389773|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389774|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389775|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389776|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389777|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389778|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389779|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389780|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389781|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389782|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389783|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389784|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389785|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389786|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389787|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389788|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389789|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389790|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389791|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389792|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389793|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389794|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389795|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389796|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389797|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389802|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389803|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389804|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389805|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389806|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389807|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389808|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389809|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389810|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389811|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389812|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389813|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389814|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389815|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389816|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389817|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389818|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389819|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389820|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389821|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389822|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389823|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389824|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389825|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389826|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389827|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389828|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389829|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389830|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389831|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389832|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389833|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
390061|NCT00450658|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
389834|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389835|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389836|NCT00457002|E2|Reported Event|Enox 40mg QD|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
389837|NCT00457002|E1|Reported Event|Apix 2.5mg BID|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
389838|NCT00457015|B3|Baseline|Total|Total of all reporting groups
389839|NCT00457015|B2|Baseline|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
389840|NCT00457015|B1|Baseline|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
389841|NCT00457015|P2|Participant Flow|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
389842|NCT00457015|P1|Participant Flow|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
389843|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
389844|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
389845|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
389846|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
389847|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
389848|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
389849|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
389850|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
389851|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
389852|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
389853|NCT00457015|E2|Reported Event|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
389854|NCT00457015|E1|Reported Event|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
389855|NCT00457197|B3|Baseline|Total|Total of all reporting groups
389856|NCT00457197|B2|Baseline|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389857|NCT00457197|B1|Baseline|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389858|NCT00457197|P2|Participant Flow|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389859|NCT00457197|P1|Participant Flow|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389860|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389861|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389862|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389863|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389864|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389865|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389866|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389867|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389902|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
390074|NCT00450749|P2|Participant Flow|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
389868|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389869|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389870|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389871|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389872|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389873|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389874|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389875|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389876|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389877|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389878|NCT00457197|E2|Reported Event|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
389879|NCT00457197|E1|Reported Event|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Placebo: Inactive ingredient matching the active medication in appearance."
389880|NCT00457249|B3|Baseline|Total|Total of all reporting groups
389881|NCT00457249|B2|Baseline|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389882|NCT00457249|B1|Baseline|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389883|NCT00457249|P2|Participant Flow|DECAVAC® Vaccine Group|Participants received a single dose of DECAVAC® vaccine.
389884|NCT00457249|P1|Participant Flow|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389885|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389886|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389887|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389888|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389889|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of DECAVAC® vaccine.
389890|NCT00457249|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389891|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389892|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389893|NCT00457249|E2|Reported Event|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389894|NCT00457249|E1|Reported Event|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
389895|NCT00457301|B3|Baseline|Total|Total of all reporting groups
389896|NCT00457301|B2|Baseline|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
389897|NCT00457301|B1|Baseline|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
389898|NCT00457301|P2|Participant Flow|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
389899|NCT00457301|P1|Participant Flow|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
389900|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
389901|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
389903|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
389904|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
389905|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
389906|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
389907|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
389908|NCT00457301|E2|Reported Event|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
389909|NCT00457301|E1|Reported Event|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
389910|NCT00457392|B3|Baseline|Total|Total of all reporting groups
389911|NCT00457392|B2|Baseline|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
389912|NCT00457392|B1|Baseline|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
389913|NCT00457392|P2|Participant Flow|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
389914|NCT00457392|P1|Participant Flow|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
389915|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
389916|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
389917|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
389918|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
389919|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
389920|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
389921|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
389922|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
389923|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
389924|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
389925|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
389926|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
389927|NCT00457392|E2|Reported Event|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
389928|NCT00457392|E1|Reported Event|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
389929|NCT00457418|B1|Baseline|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)
3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
389930|NCT00457418|P1|Participant Flow|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)
3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
389931|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)
3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
389932|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)
3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
389933|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)
3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
389934|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)
3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
389935|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)
3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
389936|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)
3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
389937|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)
3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
389938|NCT00457418|E1|Reported Event|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)
3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
389939|NCT00450424|B3|Baseline|Total|Total of all reporting groups
417783|NCT00536731|E1|Reported Event|Symbicort pMDI|Symbicort pMDI
389957|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
444934|NCT00591565|P1|Participant Flow|Acamprosate|acamprosate tablets
389940|NCT00450424|B2|Baseline|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
389941|NCT00450424|B1|Baseline|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
389942|NCT00450424|P2|Participant Flow|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor.
389943|NCT00450424|P1|Participant Flow|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
389944|NCT00450424|O2|Outcome|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
389945|NCT00450424|O1|Outcome|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
389946|NCT00450424|E2|Reported Event|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
389947|NCT00450424|E1|Reported Event|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
389948|NCT00450437|B3|Baseline|Total|Total of all reporting groups
389949|NCT00450437|B2|Baseline|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
389950|NCT00450437|B1|Baseline|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly.
389951|NCT00450437|P4|Participant Flow|Licensed Meningococcal Vaccine (19 to 55 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
389952|NCT00450437|P3|Participant Flow|Novartis MenACWY Vaccine (19 to 55 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
389953|NCT00450437|P2|Participant Flow|Licensed Meningococcal Vaccine (11 to 18 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
389954|NCT00450437|P1|Participant Flow|Novartis MenACWY Vaccine (11 to 18 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
389955|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
389956|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
390062|NCT00450658|E1|Reported Event|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
389958|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
389959|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
389960|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
389961|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
389962|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
389963|NCT00450437|O3|Outcome|Novartis MenACWY Lot 3|One dose of the meningococcal ACWY Lot 3 conjugate vaccine was administered intramuscularly.
389964|NCT00450437|O2|Outcome|Novartis MenACWY Lot 2|One dose of the meningococcal ACWY Lot 2 conjugate vaccine was administered intramuscularly.
389965|NCT00450437|O1|Outcome|Novartis MenACWY Lot 1|One dose of the meningococcal ACWY Lot 1 conjugate vaccine was administered intramuscularly.
389966|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
389967|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
389968|NCT00450437|O2|Outcome|Licensed Meninogcoccal Vaccine|One vaccination of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
389969|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
389970|NCT00450437|O3|Outcome|Novartis MenACWY Lot 3|One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
389971|NCT00450437|O2|Outcome|Novartis MenACWY Lot 2|One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
389972|NCT00450437|O1|Outcome|Novartis MenACWY Lot 1|One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
389973|NCT00450437|E2|Reported Event|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly, 11 to 55 years of age.
389974|NCT00450437|E1|Reported Event|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine (three lots combined) was administered intramuscularly, 11 to 55 years of age.
389975|NCT00450450|B3|Baseline|Total|Total of all reporting groups
389976|NCT00450450|B2|Baseline|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389977|NCT00450450|B1|Baseline|Control BM Arm|Conventional bone marrow transplant (BM)
389978|NCT00450450|P2|Participant Flow|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389979|NCT00450450|P1|Participant Flow|Control BM Arm|Conventional bone marrow transplant (BM)
389980|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389981|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
389982|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389983|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
389984|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389985|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
389986|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389987|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
389988|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389989|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
389990|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389991|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
389992|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389993|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
389994|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389995|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
389996|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389997|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
389998|NCT00450450|E2|Reported Event|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
389999|NCT00450450|E1|Reported Event|Control BM Arm|Conventional bone marrow transplant (BM)
390000|NCT00450580|B3|Baseline|Total|Total of all reporting groups
390001|NCT00450580|B2|Baseline|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
390002|NCT00450580|B1|Baseline|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
390003|NCT00450580|P2|Participant Flow|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
390004|NCT00450580|P1|Participant Flow|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
390005|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
390063|NCT00450723|B1|Baseline|Single Arm|
390064|NCT00450723|P1|Participant Flow|Sentinel Lymph Node Biopsy|
390071|NCT00450749|B2|Baseline|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
390072|NCT00450749|B1|Baseline|Arm I Placebo|Placebo once daily for 4-7 weeks.
390006|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
390007|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
390008|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
390009|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
390010|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
390011|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
390012|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
390013|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
390014|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
390015|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
390016|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
390017|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
390018|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
390019|NCT00450580|E2|Reported Event|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
390020|NCT00450580|E1|Reported Event|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
390021|NCT00450619|B3|Baseline|Total|Total of all reporting groups
390022|NCT00450619|B2|Baseline|Arm B - 153SmEDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390023|NCT00450619|B1|Baseline|Arm A -EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390024|NCT00450619|P2|Participant Flow|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390025|NCT00450619|P1|Participant Flow|Arm A- EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390026|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390027|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390028|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390029|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390030|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390031|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390065|NCT00450723|O1|Outcome|Sentinel Lymph Node BIopsy|
390032|NCT00450619|O1|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390033|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390034|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390035|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390036|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390037|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390038|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390039|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390040|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390041|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390042|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390043|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390044|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390045|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390046|NCT00450619|E2|Reported Event|Arm B - 153SmEDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
390047|NCT00450619|E1|Reported Event|Arm A -EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
390048|NCT00450658|B3|Baseline|Total|Total of all reporting groups
390049|NCT00450658|B2|Baseline|Ibuprofen|Ibuprofen 800mg
390050|NCT00450658|B1|Baseline|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
390051|NCT00450658|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg tablets t.i.d.
390052|NCT00450658|P1|Participant Flow|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg tablets t.i.d.
390053|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
390054|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
390055|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
390056|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
390057|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
390058|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
390059|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
390060|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
390075|NCT00450749|P1|Participant Flow|Arm I Placebo|Placebo once daily for 4-7 weeks.
390076|NCT00450749|O3|Outcome|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
390077|NCT00450749|O2|Outcome|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
390078|NCT00450749|O1|Outcome|Arm I Placebo|Placebo once daily for 4-7 weeks.
390079|NCT00450749|E3|Reported Event|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
390080|NCT00450749|E2|Reported Event|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
390081|NCT00450749|E1|Reported Event|Arm I Placebo|Placebo once daily for 4-7 weeks.
390082|NCT00450801|B1|Baseline|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
390083|NCT00450801|P1|Participant Flow|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
390084|NCT00450801|O3|Outcome|Thalidomide Therapy|Number of patients experiencing adverse events during Thalidomide maintenance therapy.
390085|NCT00450801|O2|Outcome|R-IVAM Cycles|Number of patients experiencing adverse events during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
390086|NCT00450801|O1|Outcome|R-MACLO Cycles|Number of patients experiencing adverse events during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
390087|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
390088|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
390089|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
390090|NCT00450801|E3|Reported Event|Thalidomide Therapy|Adverse Events occurring during Thalidomide maintenance therapy.
390091|NCT00450801|E2|Reported Event|R-IVAM Cycles|Adverse Events occurring during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
390092|NCT00450801|E1|Reported Event|R-MACLO Cycles|Adverse Events occurring during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
390093|NCT00450866|B1|Baseline|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
390094|NCT00450866|P2|Participant Flow|Epothilone B (Group B)|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
390095|NCT00450866|P1|Participant Flow|Epothilone B (Group A)|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
390096|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
390097|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
390098|NCT00450866|O2|Outcome|Epothilone B: Group B|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
390099|NCT00450866|O1|Outcome|Epothilone B: Group A|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
390100|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
390101|NCT00450866|O2|Outcome|Epothilone B: Group B|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
390102|NCT00450866|O1|Outcome|Epothilone B: Group A|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
390103|NCT00450866|E1|Reported Event|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
390104|NCT00450983|B1|Baseline|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390105|NCT00450983|P1|Participant Flow|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390106|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390107|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390108|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390109|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390110|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390111|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390112|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390113|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390114|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390115|NCT00450983|E1|Reported Event|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
390116|NCT00451048|B1|Baseline|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.
sunitinib malate: Given orally"
390117|NCT00451048|P1|Participant Flow|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.
sunitinib malate: Given orally"
390118|NCT00451048|O1|Outcome|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.
sunitinib malate: Given orally"
390119|NCT00451048|E1|Reported Event|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.
sunitinib malate: Given orally"
390120|NCT00451191|B3|Baseline|Total|Total of all reporting groups
390121|NCT00451191|B2|Baseline|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
390122|NCT00451191|B1|Baseline|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
390123|NCT00451191|P2|Participant Flow|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
390124|NCT00451191|P1|Participant Flow|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
390125|NCT00451191|O2|Outcome|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
390126|NCT00451191|O1|Outcome|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
390174|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
390175|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
390127|NCT00451191|E2|Reported Event|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
444935|NCT00591565|O1|Outcome|Acamprosate|
390128|NCT00451191|E1|Reported Event|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
390129|NCT00451204|B3|Baseline|Total|Total of all reporting groups
390130|NCT00451204|B2|Baseline|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
390131|NCT00451204|B1|Baseline|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
390132|NCT00451204|P2|Participant Flow|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
390133|NCT00451204|P1|Participant Flow|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
390134|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo capsule, once a day, treatment duration is 2 years
390135|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol 8 mg capsule, once per day, duration of treatment is 2 years
390136|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo capsule, once a day, treatment duration is 2 years
390137|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol 8 mg capsule, once per day, duration of treatment is 2 years
390138|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
390139|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
390140|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
390141|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
390142|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
390143|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
390144|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
390145|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
390146|NCT00451204|E2|Reported Event|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
390147|NCT00451204|E1|Reported Event|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
390148|NCT00451282|B3|Baseline|Total|Total of all reporting groups
390149|NCT00451282|B2|Baseline|Usual Care|Injured children receiving usual care
390150|NCT00451282|B1|Baseline|Intervention|Injured children receiving Stepped Preventive Care intervention
390151|NCT00451282|P2|Participant Flow|Usual Care|Injured children receiving usual care
390152|NCT00451282|P1|Participant Flow|Intervention|Injured children receiving Stepped Preventive Care intervention
390153|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
390154|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
390155|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
390156|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
390157|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
390158|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
390159|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
390160|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
390161|NCT00451282|E2|Reported Event|Usual Care|Injured children receiving usual care
390162|NCT00451282|E1|Reported Event|Intervention|Injured children receiving Stepped Preventive Care intervention
390163|NCT00451451|B5|Baseline|Total|Total of all reporting groups
390164|NCT00451451|B4|Baseline|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
390165|NCT00451451|B3|Baseline|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
390166|NCT00451451|B2|Baseline|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
390167|NCT00451451|B1|Baseline|Placebo|Participants received two placebo capsules orally three times daily (TID)
390168|NCT00451451|P4|Participant Flow|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
390169|NCT00451451|P3|Participant Flow|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
390170|NCT00451451|P2|Participant Flow|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
390171|NCT00451451|P1|Participant Flow|Placebo|Participants received two placebo capsules orally three times daily (TID)
390172|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
390173|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
390176|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
390177|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
390178|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
390179|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
390180|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
390181|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
390182|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
390183|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
390184|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
390185|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
390186|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
390187|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
390188|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
390189|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
390190|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
390191|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
390192|NCT00451451|E5|Reported Event|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
390193|NCT00451451|E4|Reported Event|Total BG00012|Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
390194|NCT00451451|E3|Reported Event|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
390195|NCT00451451|E2|Reported Event|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
390196|NCT00451451|E1|Reported Event|Placebo|Participants received two placebo capsules orally three times daily (TID)
390197|NCT00451698|B3|Baseline|Total|Total of all reporting groups
390198|NCT00451698|B2|Baseline|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
390199|NCT00451698|B1|Baseline|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
390200|NCT00451698|P2|Participant Flow|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
390201|NCT00451698|P1|Participant Flow|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
390202|NCT00451698|O2|Outcome|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
390203|NCT00451698|O1|Outcome|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
390204|NCT00451698|O2|Outcome|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
390205|NCT00451698|O1|Outcome|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
390206|NCT00451698|E2|Reported Event|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
390207|NCT00451698|E1|Reported Event|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
390208|NCT00451906|B1|Baseline|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
390209|NCT00451906|P1|Participant Flow|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
390255|NCT00457691|B2|Baseline|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
390476|NCT00459316|B4|Baseline|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
390210|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
390211|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
390212|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
390213|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
390214|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
390215|NCT00451906|E1|Reported Event|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
390216|NCT00451958|B5|Baseline|Total|Total of all reporting groups
390217|NCT00451958|B4|Baseline|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390218|NCT00451958|B3|Baseline|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390381|NCT00457821|O2|Outcome|Ivacaftor|All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
390219|NCT00451958|B2|Baseline|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390220|NCT00451958|B1|Baseline|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
390221|NCT00451958|P5|Participant Flow|Leuprolide 7.5 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
When the main CS21 study was completed these patients were switched to treatment with degarelix 80 mg or 160 mg in the CS21A study."
390222|NCT00451958|P4|Participant Flow|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390223|NCT00451958|P3|Participant Flow|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390224|NCT00451958|P2|Participant Flow|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390225|NCT00451958|P1|Participant Flow|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.
390226|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390227|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390228|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390229|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390240|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390230|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390231|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390232|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390233|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390234|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Leuprolide participants who dropped out during the first year (i.e. during CS21) were all attributed to what became the leuprolide 7.5 mg / degarelix 160 mg arm.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390235|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390236|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390237|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
390238|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390239|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390241|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
417784|NCT00536744|B3|Baseline|Total|Total of all reporting groups
390242|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390243|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390244|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390245|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
390246|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390247|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390248|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390249|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
390250|NCT00451958|E4|Reported Event|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390251|NCT00451958|E3|Reported Event|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390252|NCT00451958|E2|Reported Event|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
390253|NCT00451958|E1|Reported Event|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
390254|NCT00457691|B3|Baseline|Total|Total of all reporting groups
390369|NCT00457821|O2|Outcome|150 mg Ivacaftor q12h|Subjects given 150 mg of ivacaftor q12h for 28 days.
390256|NCT00457691|B1|Baseline|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
390257|NCT00457691|P2|Participant Flow|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
390258|NCT00457691|P1|Participant Flow|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
390259|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
390260|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
390261|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
390262|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
390263|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
390264|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
390265|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
390266|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
390267|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
390268|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
390269|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
390270|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
390370|NCT00457821|O1|Outcome|Placebo|Subjects given placebo every 12 hours (q12h) for 28 days.
390371|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
390271|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
390272|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
390273|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
390274|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
390275|NCT00457691|E2|Reported Event|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
390276|NCT00457691|E1|Reported Event|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
390277|NCT00457730|B3|Baseline|Total|Total of all reporting groups
390278|NCT00457730|B2|Baseline|Placebo|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.
Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.
Placebo: Subjects are randomized to either Duloxetine or Placebo"
390279|NCT00457730|B1|Baseline|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.
Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.
Placebo: Subjects are randomized to either Duloxetine or Placebo"
390280|NCT00457730|P2|Participant Flow|Placebo|subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.
390281|NCT00457730|P1|Participant Flow|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.
Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.
Placebo: Subjects are randomized to either Duloxetine or Placebo"
390282|NCT00457730|O2|Outcome|Placebo|matched placebo medication with same periods
390283|NCT00457730|O1|Outcome|Duloxetine|Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week
390284|NCT00457730|O2|Outcome|Placebo|matched placebo medication throughout 6 week observation period
390285|NCT00457730|O1|Outcome|Duloxetine|ubjects will take 30 mg daily for 1 week, then 60 mg daily for 5 weeks, then titrate back down to 30 mg daily for 1 week.
390286|NCT00457730|O2|Outcome|Placebo|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.
Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.
Placebo: Subjects are randomized to either Duloxetine or Placebo"
390287|NCT00457730|O1|Outcome|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.
Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.
Placebo: Subjects are randomized to either Duloxetine or Placebo"
390288|NCT00457730|E2|Reported Event|Placebo|Placebo: Matching placebo drug for 7 weeks total
390289|NCT00457730|E1|Reported Event|Duloxetine|Study drug, Duloxetine, 30 mg for 1 week, titrate up to 60 mg for 5 weeks and titrate back down to 30 mg for 1 week.
390290|NCT00457743|B4|Baseline|Total|Total of all reporting groups
390291|NCT00457743|B3|Baseline|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390372|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
390373|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
390374|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
390375|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
390383|NCT00457821|E5|Reported Event|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
390384|NCT00457821|E4|Reported Event|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
444936|NCT00591565|E1|Reported Event|Acamprosate|acamprosate tablets
390292|NCT00457743|B2|Baseline|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390293|NCT00457743|B1|Baseline|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390294|NCT00457743|P3|Participant Flow|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390295|NCT00457743|P2|Participant Flow|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390296|NCT00457743|P1|Participant Flow|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390297|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390298|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390299|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390300|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390301|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390376|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
390382|NCT00457821|O1|Outcome|Placebo|All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
390302|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390303|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390304|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390305|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390306|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390307|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390308|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390309|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390310|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390311|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390377|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
390378|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
390312|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390313|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390314|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390315|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390316|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390317|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390318|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390319|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390320|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390321|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390379|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
390413|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
390322|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390323|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390324|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390325|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390326|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390327|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390328|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390329|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390330|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390331|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390380|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
418898|NCT00526097|B3|Baseline|Total|Total of all reporting groups
390332|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390333|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390334|NCT00457743|E3|Reported Event|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390335|NCT00457743|E2|Reported Event|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.
From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
390336|NCT00457743|E1|Reported Event|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.
Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.
Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
390337|NCT00457795|B1|Baseline|Brimonidine 0.1%|Brimonidine 0.1%
390338|NCT00457795|P1|Participant Flow|Brimonidine 0.1%|Brimonidine 0.1%
390339|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
390340|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
390341|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
390342|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
390343|NCT00457795|E1|Reported Event|Brimonidine 0.1%|Brimonidine 0.1%
390344|NCT00457821|B9|Baseline|Total|Total of all reporting groups
390345|NCT00457821|B8|Baseline|Part 2: Placebo|Part 2: placebo q12h; 28 days
390346|NCT00457821|B7|Baseline|Part 2: 250 mg|Part 2: Ivacaftor (250 mg) q12h; 28 days
390347|NCT00457821|B6|Baseline|Part 2: 150 mg|Part 2: Ivacaftor (150 mg) q12h; 28 days
390348|NCT00457821|B5|Baseline|Part 1: 150 mg/75 mg|Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
390349|NCT00457821|B4|Baseline|Part 1: 75 mg/150 mg|Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
390350|NCT00457821|B3|Baseline|Part 1: 75 mg/25 mg|Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
390351|NCT00457821|B2|Baseline|Part 1: 25 mg/75 mg|Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
390352|NCT00457821|B1|Baseline|Part 1: Placebo|Part 1: placebo every 12 hours (q12h); 14 days/14 days.
390353|NCT00457821|P8|Participant Flow|Part 2: Placebo|Part 2: placebo q12h; 28 days
390354|NCT00457821|P7|Participant Flow|Part 2: 250 mg|Part 2: Ivacaftor (250 mg) q12h; 28 days
390355|NCT00457821|P6|Participant Flow|Part 2: 150 mg|Part 2: Ivacaftor (150 mg) q12h; 28 days
390356|NCT00457821|P5|Participant Flow|Part 1: 150 mg/75 mg|Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
390357|NCT00457821|P4|Participant Flow|Part 1: 75 mg/150 mg|Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
390358|NCT00457821|P3|Participant Flow|Part 1: 75 mg/25 mg|Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
390359|NCT00457821|P2|Participant Flow|Part 1: 25 mg/75 mg|Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
390360|NCT00457821|P1|Participant Flow|Part 1: Placebo|Part 1: placebo every 12 hours (q12h); 14 days/14 days.
390361|NCT00457821|O2|Outcome|Ivacaftor|All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
390362|NCT00457821|O1|Outcome|Placebo|All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
390363|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
390364|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
390365|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
390366|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
390367|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
390368|NCT00457821|O3|Outcome|250 mg Ivacaftor q12h|Subjects given 250 mg of ivacaftor q12h for 28 days.
420261|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
390385|NCT00457821|E3|Reported Event|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
390386|NCT00457821|E2|Reported Event|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
390387|NCT00457821|E1|Reported Event|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
390388|NCT00458705|B1|Baseline|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
390389|NCT00458705|P1|Participant Flow|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
390390|NCT00458705|O1|Outcome|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
390391|NCT00458705|E1|Reported Event|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
390392|NCT00458822|B1|Baseline|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
390393|NCT00458822|P1|Participant Flow|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
390394|NCT00458822|O1|Outcome|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
390395|NCT00458822|E1|Reported Event|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
390396|NCT00458952|B3|Baseline|Total|Total of all reporting groups
390397|NCT00458952|B2|Baseline|>500 mCi|14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
390398|NCT00458952|B1|Baseline|=< 500 mCi Ultratrace Iobenguane I 131|7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
390399|NCT00458952|P2|Participant Flow|>500 mCi|14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
390400|NCT00458952|P1|Participant Flow|=< 500 mCi Ultratrace Iobenguane I 131|7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
390401|NCT00458952|O1|Outcome|Ultratrace Iobenguane I 131|Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
390402|NCT00458952|E1|Reported Event|Ultratrace Iobenguane I 131|Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
390403|NCT00459043|B3|Baseline|Total|Total of all reporting groups
390404|NCT00459043|B2|Baseline|Combination of Docetaxel and Zactima|
390405|NCT00459043|B1|Baseline|Docetaxel Single Agent|
390406|NCT00459043|P2|Participant Flow|2 Combination Docetaxel and ZD6474|"Docetaxel with ZD6474
Docetaxel 75 mg/m2 was administered every 21 days intravenously. ZD6474 (Vandetanib) at 100 mg was administered as a once daily tablet given orally."
390407|NCT00459043|P1|Participant Flow|1Docetaxel Single Agent|Docetaxel 75 mg/m2 was administered every 21 days intravenously.
390408|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
390409|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
390410|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
390411|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
390412|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
390414|NCT00459043|E2|Reported Event|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
390415|NCT00459043|E1|Reported Event|1Docetaxel Single Agent|Docetaxel Alone
390416|NCT00459056|B3|Baseline|Total|Total of all reporting groups
390417|NCT00459056|B2|Baseline|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCTZ for the first three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.
390418|NCT00459056|B1|Baseline|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a washout period for one month, and then were given Lisinopril + HCTZ for the final three months.
390419|NCT00459056|P2|Participant Flow|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCT for three months, then had a one month wash-out period, and then were randomized to Carvedilol CR + Lisinopril for the remaining three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, Lisinophil was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
390420|NCT00459056|P1|Participant Flow|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for three months, then had a one month wash-out period, and then were randomized to Lisinopril + HCT for the remaining three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
390421|NCT00459056|O2|Outcome|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisionopril +HCTZ for the first three months, then had a one month washout period, then were given Carvedilol CR + Lisinopril for the final three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
390422|NCT00459056|O1|Outcome|Carvedilol CR + Lisinopril, Then Lisinopril +HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a one month washout period, then were given Lisinopril + HCTZ for the final three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
390423|NCT00459056|E2|Reported Event|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCTZ for the first three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.
390424|NCT00459056|E1|Reported Event|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a washout period for one month, and then were given Lisinopril + HCTZ for the final three months.
390425|NCT00459108|B1|Baseline|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
dasatinib: Given orally"
390426|NCT00459108|P1|Participant Flow|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
dasatinib: Given orally"
390427|NCT00459108|O1|Outcome|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
dasatinib: Given orally"
390428|NCT00459108|O1|Outcome|Oral Dasatinib|"Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
dasatinib: Given orally"
390429|NCT00459108|E1|Reported Event|Oral Dasatinib|"Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
dasatinib: Given orally"
390430|NCT00459121|B1|Baseline|Zactima, Paclitaxel, Carboplatin|"Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.
Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment."
390431|NCT00459121|P1|Participant Flow|Zactima, Paclitaxel, Carboplatin|"Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.
Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment."
390432|NCT00459121|O1|Outcome|Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety|Study closed before an evaluable number of participants could be accrued. No summary of statistics will be collected for two participants, per the statistician.
390433|NCT00459121|E1|Reported Event|Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety|Study closed before an evaluable number of participants could be accrued. No summary of statistics will be collected for two participants, per the statistician.
390434|NCT00459134|B3|Baseline|Total|Total of all reporting groups
390435|NCT00459134|B2|Baseline|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily
Placebo: Given orally"
420262|NCT00529087|O3|Outcome|Placebo|Once daily
390436|NCT00459134|B1|Baseline|Arm I: ArginMax|"ArginMax® 3 pills twice daily
ArginMax: Given orally"
390437|NCT00459134|P2|Participant Flow|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily
Placebo: Given orally"
390438|NCT00459134|P1|Participant Flow|Arm I: ArginMax|"ArginMax® 3 pills twice daily
ArginMax: Given orally"
390439|NCT00459134|O2|Outcome|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily
Placebo: Given orally"
390440|NCT00459134|O1|Outcome|Arm I: ArginMax|"ArginMax® 3 pills twice daily
ArginMax: Given orally"
390441|NCT00459134|O2|Outcome|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily
Placebo: Given orally"
390442|NCT00459134|O1|Outcome|Arm I: ArginMax|"ArginMax® 3 pills twice daily
ArginMax: Given orally"
390443|NCT00459134|E2|Reported Event|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily
Placebo: Given orally"
390444|NCT00459134|E1|Reported Event|Arm I: ArginMax|"ArginMax® 3 pills twice daily
ArginMax: Given orally"
390445|NCT00459186|B1|Baseline|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
390446|NCT00459186|P1|Participant Flow|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
390447|NCT00459186|O1|Outcome|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
390448|NCT00459186|O1|Outcome|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
390449|NCT00459186|E1|Reported Event|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
390450|NCT00459290|B1|Baseline|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
390451|NCT00459290|P1|Participant Flow|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
390452|NCT00459290|O3|Outcome|>=70|
390453|NCT00459290|O2|Outcome|60 <70|
390454|NCT00459290|O1|Outcome|< 60|
390455|NCT00459290|O2|Outcome|GOG Performance Status 1|Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
390456|NCT00459290|O1|Outcome|GOG Performance Status 0|Fully active, able to carry on all pre-disease performance without restriction.
390457|NCT00459290|O2|Outcome|Platinum Sensitive|
390458|NCT00459290|O1|Outcome|Not Platinum Sensitive|
390459|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
390460|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
390461|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
390462|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
390463|NCT00459290|E1|Reported Event|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
390464|NCT00459303|B1|Baseline|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
390465|NCT00459303|P1|Participant Flow|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye.
390466|NCT00459303|O2|Outcome|Aspheric Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
390467|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
390468|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
390469|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
390470|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
390471|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
390472|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived aspherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
390473|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
390474|NCT00459303|E1|Reported Event|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
390477|NCT00459316|B3|Baseline|Group 2|Participants ≥11 to <25 years with CD4%<15
390478|NCT00459316|B2|Baseline|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
390479|NCT00459316|B1|Baseline|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%<25
390480|NCT00459316|P3|Participant Flow|Group 3: Age ≥2 to <11, CD4%≥25|"Participants ≥2 to <11 years of age with CD4% at screening ≥ 25%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.
Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
390481|NCT00459316|P2|Participant Flow|Group 2: CD4%<15, Age ≤11 to <25|"Participants ≤11 to <25 years of age with CD4% at screening <15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24.
Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
390482|NCT00459316|P1|Participant Flow|Group 1: CD4%≥15, Age ≤11 to <25|"Participants ≤11 to <25 years of age with CD4% at screening ≥15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible/randomized receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.
Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
390483|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25, 2 doses MCV4 vaccine
390484|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
390485|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
390486|NCT00459316|O2|Outcome|Group 3|Participants >=2 to <11 years of age with CD4% at screening ≥ 25%
390487|NCT00459316|O1|Outcome|Group 1|Participants ≤11 to <25 years of age with CD4% at screening ≥15%
390488|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
390489|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
390490|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
390491|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
390492|NCT00459316|O4|Outcome|Group 3: Age 6-<11|Participants 6 to <11 years with CD4%>=25
390493|NCT00459316|O3|Outcome|Group 3: Age 2-<6|Participants 2 to <6 years with CD4%>=25
390494|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
390495|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
390496|NCT00459316|O3|Outcome|Week 72|Group 2 participants at Week 72
390497|NCT00459316|O2|Outcome|Week 28|Group 2 participants at Week 28 (4 weeks after second vaccination)
390498|NCT00459316|O1|Outcome|Week 4|Group 2 participants at Week 4
390499|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
390500|NCT00459316|O2|Outcome|Group 1B|Participants aged 11 to 24 with a CD4 percentage of or greater than 15%, 2 doses MCV4 vaccine
390501|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
390502|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
390503|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
390504|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
390505|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
390506|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
390507|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
390508|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
390509|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
390510|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
390511|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
390512|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
390513|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
390514|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
390515|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
390516|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
390517|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
390518|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
390519|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
390520|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
390521|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
390522|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
390523|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
390524|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
390525|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
390526|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
390527|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
390528|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
390529|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
390530|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
390531|NCT00459316|E4|Reported Event|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
390532|NCT00459316|E3|Reported Event|Group 2|Participants ≥11 to <25 years with CD4%<15
390533|NCT00459316|E2|Reported Event|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
390534|NCT00459316|E1|Reported Event|Group 1 (15<CD4%≤25)|Participants ≥11 to <25 years with 15<CD4%≤25
390535|NCT00459342|B1|Baseline|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
390536|NCT00459342|P1|Participant Flow|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
390537|NCT00459342|O1|Outcome|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
390538|NCT00459342|O1|Outcome|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
390539|NCT00459342|E1|Reported Event|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
390540|NCT00459355|B3|Baseline|Total|Total of all reporting groups
390541|NCT00459355|B2|Baseline|Checklist|Received conventional home safety checklist
390542|NCT00459355|B1|Baseline|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
390543|NCT00459355|P2|Participant Flow|Checklist|Group receives conventional home safety checklist
390544|NCT00459355|P1|Participant Flow|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
390545|NCT00459355|O2|Outcome|Conventional Safety Checklist|Comparison group received a conventional home safety checklist
390546|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
390547|NCT00459355|O2|Outcome|Checklist|Conventional home safety checklist
390548|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
390549|NCT00459355|O2|Outcome|Checklist|non-intervention group received conventional home safety checklist
390550|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
390551|NCT00459355|E4|Reported Event|Checklist:Caregivers|Control group receives conventional list of home safety recommendations
390552|NCT00459355|E3|Reported Event|Home Safety Toolkit:Caregivers|Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
390553|NCT00459355|E2|Reported Event|Checklist:Care Recipients|Control group receives conventional list of home safety recommendations
390554|NCT00459355|E1|Reported Event|Home Safety Toolkit:Care Recipients|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
390555|NCT00459368|B3|Baseline|Total|Total of all reporting groups
390556|NCT00459368|B2|Baseline|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
390557|NCT00459368|B1|Baseline|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
390558|NCT00459368|P2|Participant Flow|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
390559|NCT00459368|P1|Participant Flow|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
390560|NCT00459368|O2|Outcome|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
420646|NCT00529555|B4|Baseline|Total|Total of all reporting groups
390586|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
390587|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
390561|NCT00459368|O1|Outcome|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
390562|NCT00459368|E2|Reported Event|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
390563|NCT00459368|E1|Reported Event|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
390564|NCT00459381|B1|Baseline|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
pazopanib hydrochloride: Given orally
laboratory biomarker analysis: Correlative studies"
390565|NCT00459381|P1|Participant Flow|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
pazopanib hydrochloride: Given orally
laboratory biomarker analysis: Correlative studies"
390566|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
pazopanib hydrochloride: Given orally
laboratory biomarker analysis: Correlative studies"
390567|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
pazopanib hydrochloride: Given orally
laboratory biomarker analysis: Correlative studies"
390568|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
pazopanib hydrochloride: Given orally
laboratory biomarker analysis: Correlative studies"
390569|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
pazopanib hydrochloride: Given orally
laboratory biomarker analysis: Correlative studies"
390570|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
pazopanib hydrochloride: Given orally
laboratory biomarker analysis: Correlative studies"
390571|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
pazopanib hydrochloride: Given orally
laboratory biomarker analysis: Correlative studies"
390572|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
pazopanib hydrochloride: Given orally
laboratory biomarker analysis: Correlative studies"
390573|NCT00459381|E1|Reported Event|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
pazopanib hydrochloride: Given orally
laboratory biomarker analysis: Correlative studies"
390574|NCT00459537|B3|Baseline|Total|Total of all reporting groups
390575|NCT00459537|B2|Baseline|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
390576|NCT00459537|B1|Baseline|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
390577|NCT00459537|P2|Participant Flow|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
390578|NCT00459537|P1|Participant Flow|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
390579|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
390580|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
390581|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
390582|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
390583|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
390584|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
390585|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
390627|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390588|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
390589|NCT00459537|E2|Reported Event|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
390590|NCT00459537|E1|Reported Event|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
390591|NCT00459667|B4|Baseline|Total|Total of all reporting groups
390592|NCT00459667|B3|Baseline|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day
*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
390593|NCT00459667|B2|Baseline|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
390594|NCT00459667|B1|Baseline|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
390595|NCT00459667|P3|Participant Flow|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day
*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
390596|NCT00459667|P2|Participant Flow|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
390597|NCT00459667|P1|Participant Flow|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
390598|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day
*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
390599|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
390600|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
390601|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day
*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
390602|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
390603|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
390604|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day
*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
390605|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
390606|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
390607|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day
*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
390608|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
390609|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
390610|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day
*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
390611|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
390612|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
390613|NCT00459667|E3|Reported Event|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day
*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
390614|NCT00459667|E2|Reported Event|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
390615|NCT00459667|E1|Reported Event|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
390616|NCT00459706|B3|Baseline|Total|Total of all reporting groups
390617|NCT00459706|B2|Baseline|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390618|NCT00459706|B1|Baseline|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390619|NCT00459706|P2|Participant Flow|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390620|NCT00459706|P1|Participant Flow|Enbrel 50 mg Autoinjector|Enbrel 50 milligram (mg) once weekly subcutaneously for 12 Weeks using autoinjector
390621|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390622|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390623|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390624|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390625|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390626|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390628|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390629|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390630|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390631|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390632|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390633|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390634|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390635|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390636|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390637|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390638|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390639|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390640|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390641|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390642|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390643|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390644|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390645|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390646|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390647|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390648|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390649|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390650|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390651|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390652|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390653|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390654|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390655|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390656|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390657|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390658|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390659|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390660|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390661|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390662|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390663|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390664|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390665|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390666|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390667|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390668|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390669|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390670|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390671|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390672|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390673|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390674|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390675|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390676|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390677|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390678|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390679|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390680|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390681|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390682|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390683|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390684|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390685|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390686|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390687|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390688|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390689|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390690|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390691|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390692|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390693|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390694|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390695|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390696|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390697|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390698|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390699|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390700|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390701|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390702|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390703|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390704|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390705|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390706|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390707|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390708|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390709|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390710|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390711|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390712|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390713|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390714|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390715|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390716|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390717|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390718|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390719|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390720|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390721|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390722|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390723|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390724|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390725|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390726|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390727|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390728|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390729|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390730|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390731|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390732|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390733|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390734|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390735|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390736|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390737|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390738|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390739|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390740|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390741|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390742|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390743|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390744|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390745|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390746|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390747|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390748|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390749|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390750|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390751|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390752|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390753|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390754|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390755|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390756|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390757|NCT00459706|E2|Reported Event|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
390758|NCT00459706|E1|Reported Event|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
390759|NCT00459732|B3|Baseline|Total|Total of all reporting groups
390760|NCT00459732|B2|Baseline|Placebo|daily capsule similar in size/color to zn was taken daily by this group
390761|NCT00459732|B1|Baseline|Zinc|25 mg of zinc as zn sulfate taken daily
390762|NCT00459732|P2|Participant Flow|Placebo|daily capsule similar in size/color to zn was taken daily by this group
390763|NCT00459732|P1|Participant Flow|Zinc|25 mg of zinc as zn sulfate taken daily
390764|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
390765|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
390766|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
390767|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
390768|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
390769|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
390770|NCT00459732|E2|Reported Event|Placebo|daily capsule similar in size/color to zn was taken daily by this group
390771|NCT00459732|E1|Reported Event|Zinc|25 mg of zinc as zn sulfate taken daily
390772|NCT00459810|B1|Baseline|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
390773|NCT00459810|P1|Participant Flow|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
390774|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
390775|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
390776|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
390777|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
390778|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
390806|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy"
390779|NCT00459810|E1|Reported Event|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
390780|NCT00459862|B1|Baseline|Arm I|Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
390781|NCT00459862|P1|Participant Flow|Arm I|Patients receive 800mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
390782|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
390783|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
390784|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
390785|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
390786|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
390787|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
390788|NCT00459862|E1|Reported Event|Arm I|Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
390789|NCT00459875|B1|Baseline|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.
sunitinib malate"
390790|NCT00459875|P1|Participant Flow|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.
sunitinib malate"
390791|NCT00459875|O1|Outcome|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.
sunitinib malate"
390792|NCT00459875|E1|Reported Event|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.
sunitinib malate"
390793|NCT00459953|B3|Baseline|Total|Total of all reporting groups
390794|NCT00459953|B2|Baseline|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
390795|NCT00459953|B1|Baseline|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy
Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
390796|NCT00459953|P2|Participant Flow|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
390797|NCT00459953|P1|Participant Flow|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy
Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
390798|NCT00459953|O2|Outcome|Control Group|Monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
390799|NCT00459953|O1|Outcome|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy
Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
390800|NCT00459953|E2|Reported Event|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
390801|NCT00459953|E1|Reported Event|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy
Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
390802|NCT00459979|B1|Baseline|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy"
390803|NCT00459979|P1|Participant Flow|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy"
390896|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
390804|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy"
390805|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy"
390807|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy"
390808|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy"
390809|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy"
390810|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy"
390811|NCT00459979|E1|Reported Event|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy"
390812|NCT00460031|B1|Baseline|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
390813|NCT00460031|P1|Participant Flow|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
390814|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
390815|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
390816|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
390817|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
390818|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
390819|NCT00460031|E1|Reported Event|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
390820|NCT00460109|B1|Baseline|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
390821|NCT00460109|P1|Participant Flow|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
390822|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
390823|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
390824|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
390825|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
390826|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
390827|NCT00460109|E1|Reported Event|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
390828|NCT00460239|B1|Baseline|All Study Participants|All Study Participants
390897|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
390898|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
390899|NCT00460239|O3|Outcome|Morphine 30 mg|
390900|NCT00460239|O2|Outcome|Morphine 15 mg|
390829|NCT00460239|P9|Participant Flow|Condition 9|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, B8, B16, B32, M30, P, B48, B60.
391643|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
390830|NCT00460239|P8|Participant Flow|Condition 8|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): P, M30, M15, B8, B16, B32, B48, B60.
390831|NCT00460239|P7|Participant Flow|Condition 7|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M30, B8, P, B16, M15, B32, B48, B60.
390832|NCT00460239|P6|Participant Flow|Condition 6|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, P, B8, M30, B16, B32, P, B48, B60.
390833|NCT00460239|P5|Participant Flow|Condition 5|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, M30, B32, P, B48, M15, B60.
390834|NCT00460239|P4|Participant Flow|Condition 4|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, M15, B16, P, B32, M30, B48, B60.
390835|NCT00460239|P3|Participant Flow|Condition 3|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, M30, B60, P, M15.
390836|NCT00460239|P2|Participant Flow|Condition 2|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, M15, B48, P, B60, M30.
390837|NCT00460239|P1|Participant Flow|Condition 1|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, B60, M15, M30, P.
390838|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
390839|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
390840|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
390841|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
390842|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
390843|NCT00460239|O3|Outcome|Morphine 30 mg|
390844|NCT00460239|O2|Outcome|Morphine 15 mg|
390845|NCT00460239|O1|Outcome|Placebo 0 mg|
390846|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
390847|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
390848|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
390849|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
390850|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
390851|NCT00460239|O3|Outcome|Morphine 30 mg|
390852|NCT00460239|O2|Outcome|Morphine 15 mg|
390853|NCT00460239|O1|Outcome|Placebo 0 mg|
390854|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
390855|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
390856|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
390857|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
390858|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
390859|NCT00460239|O3|Outcome|Morphine 30 mg|
390860|NCT00460239|O2|Outcome|Morphine 15 mg|
390861|NCT00460239|O1|Outcome|Placebo 0 mg|
390862|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
390863|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
390864|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
390865|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
390866|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
390867|NCT00460239|O3|Outcome|Morphine 30 mg|
390868|NCT00460239|O2|Outcome|Morphine 15 mg|
390869|NCT00460239|O1|Outcome|Placebo 0 mg|
390870|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
390871|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
390872|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
390873|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
390874|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
390875|NCT00460239|O3|Outcome|Morphine 30 mg|
390876|NCT00460239|O2|Outcome|Morphine 15 mg|
390877|NCT00460239|O1|Outcome|Placebo 0 mg|
390878|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
390879|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
390880|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
390881|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
390882|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
390883|NCT00460239|O3|Outcome|Morphine 30 mg|
390884|NCT00460239|O2|Outcome|Morphine 15 mg|
390885|NCT00460239|O1|Outcome|Placebo 0 mg|
390886|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
390887|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
390888|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
390889|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
390890|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
390891|NCT00460239|O3|Outcome|Morphine 30 mg|
390892|NCT00460239|O2|Outcome|Morphine 15 mg|
390893|NCT00460239|O1|Outcome|Placebo 0 mg|
390894|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
390895|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
390906|NCT00460265|B2|Baseline|Chemotherapy Alone|Consists of Cisplatin and 5-FU
390907|NCT00460265|B1|Baseline|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
390908|NCT00460265|P2|Participant Flow|Chemotherapy Alone|Consists of Cisplatin and 5-FU
444937|NCT00591578|B4|Baseline|Total|Total of all reporting groups
390909|NCT00460265|P1|Participant Flow|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
390910|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
390911|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
390912|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
390913|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
390914|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
390915|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
390916|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
390917|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
390918|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
390919|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
390920|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
390921|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
390922|NCT00460265|E2|Reported Event|Chemotherapy Alone|
390923|NCT00460265|E1|Reported Event|Panitumumab Plus Chemotherapy|
390924|NCT00460408|B5|Baseline|Total|Total of all reporting groups
390925|NCT00460408|B4|Baseline|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
390926|NCT00460408|B3|Baseline|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390927|NCT00460408|B2|Baseline|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
390928|NCT00460408|B1|Baseline|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390929|NCT00460408|P4|Participant Flow|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
390930|NCT00460408|P3|Participant Flow|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390931|NCT00460408|P2|Participant Flow|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
390932|NCT00460408|P1|Participant Flow|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390933|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
390934|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390935|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
390936|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390937|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
390938|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390939|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
390940|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
391003|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391370|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
391005|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391376|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
390941|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
390942|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390943|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
390944|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390945|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
390946|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390947|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
390948|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390949|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390950|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
390951|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390952|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
390953|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390954|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
390955|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390956|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
390957|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390958|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
390959|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390960|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
390961|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390962|NCT00460408|E4|Reported Event|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
390963|NCT00460408|E3|Reported Event|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
391004|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391637|NCT00461292|B2|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
390964|NCT00460408|E2|Reported Event|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
390965|NCT00460408|E1|Reported Event|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
390966|NCT00460421|B4|Baseline|Total|Total of all reporting groups
390967|NCT00460421|B3|Baseline|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390968|NCT00460421|B2|Baseline|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390969|NCT00460421|B1|Baseline|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390970|NCT00460421|P3|Participant Flow|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390971|NCT00460421|P2|Participant Flow|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390972|NCT00460421|P1|Participant Flow|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390973|NCT00460421|O4|Outcome|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
390974|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390975|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390976|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390977|NCT00460421|O4|Outcome|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
390978|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390979|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390980|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390981|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390982|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390983|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390984|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390985|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390986|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390987|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390988|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390989|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390990|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390991|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390992|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390993|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390994|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390995|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390996|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390997|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390998|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
390999|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391000|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391001|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391002|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391371|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
391006|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391007|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391008|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391009|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391010|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391011|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391012|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391013|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
391014|NCT00460421|E1|Reported Event|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
391015|NCT00460525|B3|Baseline|Total|Total of all reporting groups
391016|NCT00460525|B2|Baseline|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391017|NCT00460525|B1|Baseline|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391018|NCT00460525|P2|Participant Flow|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391019|NCT00460525|P1|Participant Flow|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391020|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391021|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391022|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391023|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391024|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391025|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391026|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391027|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391028|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391029|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391030|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391031|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391032|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391033|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391034|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391035|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391036|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391037|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391038|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391039|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391040|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391041|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391042|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391043|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391044|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391045|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391046|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391047|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391048|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391049|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391050|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391051|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391052|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391053|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391054|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391055|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391056|NCT00460525|E2|Reported Event|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
391057|NCT00460525|E1|Reported Event|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
391058|NCT00460551|B1|Baseline|Zalutumumab 8 mg/kg|
391059|NCT00460551|P1|Participant Flow|Zalutumumab 8 mg/kg|
391060|NCT00460551|O1|Outcome|Zalatumumab 8 mg/kg|
391061|NCT00460551|O1|Outcome|Zalatumumab 8 mg/kg|
391062|NCT00460551|E1|Reported Event|Zalutumumab 8 mg/kg|
391063|NCT00460564|B5|Baseline|Total|Total of all reporting groups
391375|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
391064|NCT00460564|B4|Baseline|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391065|NCT00460564|B3|Baseline|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391066|NCT00460564|B2|Baseline|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391067|NCT00460564|B1|Baseline|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391068|NCT00460564|P8|Participant Flow|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391069|NCT00460564|P7|Participant Flow|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391070|NCT00460564|P6|Participant Flow|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391071|NCT00460564|P5|Participant Flow|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391072|NCT00460564|P4|Participant Flow|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391073|NCT00460564|P3|Participant Flow|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391074|NCT00460564|P2|Participant Flow|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391075|NCT00460564|P1|Participant Flow|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391076|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391077|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391078|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391079|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391080|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391081|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391133|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391082|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391083|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391084|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391085|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391086|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391087|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391088|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391089|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391090|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391091|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391092|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391093|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391094|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391095|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391134|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391372|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
391096|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391097|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391098|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391099|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391100|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391101|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391102|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391103|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391104|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391105|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391106|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391107|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391108|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391109|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391135|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391638|NCT00461292|B1|Baseline|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
391110|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391111|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391112|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391113|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391114|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391115|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391116|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391117|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391118|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391119|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391120|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391121|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391122|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391123|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391124|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391125|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391126|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391127|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391128|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391129|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391130|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391131|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391132|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391373|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
391136|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391137|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391138|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391139|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391140|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391141|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391142|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391143|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391144|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391145|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391146|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391147|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391148|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391149|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391150|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391151|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391152|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391153|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391154|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391155|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391156|NCT00460564|O2|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391157|NCT00460564|O1|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391158|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391159|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391160|NCT00460564|E8|Reported Event|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391161|NCT00460564|E7|Reported Event|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391338|NCT00460746|P1|Participant Flow|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391162|NCT00460564|E6|Reported Event|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391163|NCT00460564|E5|Reported Event|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
391164|NCT00460564|E4|Reported Event|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391165|NCT00460564|E3|Reported Event|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
391166|NCT00460564|E2|Reported Event|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391167|NCT00460564|E1|Reported Event|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
391168|NCT00460577|B3|Baseline|Total|Total of all reporting groups
391169|NCT00460577|B2|Baseline|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
391170|NCT00460577|B1|Baseline|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
391171|NCT00460577|P2|Participant Flow|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
391172|NCT00460577|P1|Participant Flow|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
391173|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
391174|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
391175|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
391176|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
391177|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
391178|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
391179|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
391180|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
391181|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
391182|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
391183|NCT00460577|E2|Reported Event|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
391184|NCT00460577|E1|Reported Event|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
391185|NCT00460603|B13|Baseline|Total|Total of all reporting groups
391186|NCT00460603|B12|Baseline|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391187|NCT00460603|B11|Baseline|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391188|NCT00460603|B10|Baseline|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391309|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391374|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
391189|NCT00460603|B9|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391190|NCT00460603|B8|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391191|NCT00460603|B7|Baseline|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391192|NCT00460603|B6|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391193|NCT00460603|B5|Baseline|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391194|NCT00460603|B4|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391195|NCT00460603|B3|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391196|NCT00460603|B2|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391197|NCT00460603|B1|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)|Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391337|NCT00460746|B1|Baseline|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391639|NCT00461292|P3|Participant Flow|Placebo|Normal saline (placebo)
391198|NCT00460603|P12|Participant Flow|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391199|NCT00460603|P11|Participant Flow|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391200|NCT00460603|P10|Participant Flow|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391201|NCT00460603|P9|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391202|NCT00460603|P8|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391203|NCT00460603|P7|Participant Flow|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391204|NCT00460603|P6|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391205|NCT00460603|P5|Participant Flow|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391206|NCT00460603|P4|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391235|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391207|NCT00460603|P3|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391208|NCT00460603|P2|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391209|NCT00460603|P1|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)|Bevacizumab 1 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 milligram per square meter (mg/m^2) intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-fluorouracil (5-FU) 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391210|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391211|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391212|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391213|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391214|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391215|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391302|NCT00460655|B1|Baseline|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391303|NCT00460655|P4|Participant Flow|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391216|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391217|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391218|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391219|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391220|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391221|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391222|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391223|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391224|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391225|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391362|NCT00460811|B2|Baseline|145 µg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
391363|NCT00460811|B1|Baseline|72 µg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
391226|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391227|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391228|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391229|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391230|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391231|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391232|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391233|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391234|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391364|NCT00460811|P5|Participant Flow|Matching Placebo|Dose-matched placebo, oral administration, once per day
391365|NCT00460811|P4|Participant Flow|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
391236|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391237|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391238|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391239|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391240|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391241|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391242|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391243|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391244|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391304|NCT00460655|P3|Participant Flow|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391305|NCT00460655|P2|Participant Flow|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391245|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391246|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391247|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391248|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391249|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391250|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391251|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391252|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391253|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391306|NCT00460655|P1|Participant Flow|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391366|NCT00460811|P3|Participant Flow|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
391367|NCT00460811|P2|Participant Flow|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
391254|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391255|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391256|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391257|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391258|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391259|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391260|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391261|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391262|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391368|NCT00460811|P1|Participant Flow|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
391369|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
391263|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391264|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391265|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391266|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391267|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391268|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391269|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391270|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391271|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391307|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
421243|NCT00540124|O1|Outcome|Placebo|by mouth once a day
391272|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391273|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391274|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391275|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391276|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391277|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391278|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391279|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391280|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391308|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
421244|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
391281|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391282|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391283|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391284|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391285|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391286|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391287|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391288|NCT00460603|E12|Reported Event|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391289|NCT00460603|E11|Reported Event|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391290|NCT00460603|E10|Reported Event|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391291|NCT00460603|E9|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391292|NCT00460603|E8|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391293|NCT00460603|E7|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391294|NCT00460603|E6|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391295|NCT00460603|E5|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391296|NCT00460603|E4|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391297|NCT00460603|E3|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391298|NCT00460603|E2|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391299|NCT00460603|E1|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 1)|Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
391300|NCT00460655|B3|Baseline|Total|Total of all reporting groups
391301|NCT00460655|B2|Baseline|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391310|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391311|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391312|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391313|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391314|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391315|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391316|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391317|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391318|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391319|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391320|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391321|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391322|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391323|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391324|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391325|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391326|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391327|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391328|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391329|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391330|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391331|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391332|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391333|NCT00460655|E4|Reported Event|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391334|NCT00460655|E3|Reported Event|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
391335|NCT00460655|E2|Reported Event|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391336|NCT00460655|E1|Reported Event|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
391339|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391340|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391341|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391342|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391343|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391344|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391345|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391346|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391347|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391348|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391349|NCT00460746|E1|Reported Event|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
391350|NCT00460798|B1|Baseline|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
391351|NCT00460798|P1|Participant Flow|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
391352|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
391353|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
391354|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
391355|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
391356|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
391357|NCT00460798|E1|Reported Event|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
391358|NCT00460811|B6|Baseline|Total|Total of all reporting groups
391359|NCT00460811|B5|Baseline|Matching Placebo|Dose-matched placebo, oral administration, once per day
391360|NCT00460811|B4|Baseline|579 µg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
391361|NCT00460811|B3|Baseline|290 µg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
391377|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
391378|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
391379|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
391380|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
391381|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
391382|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
391383|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
391384|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
391385|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
391386|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
391387|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
391388|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
391389|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
391390|NCT00460811|O4|Outcome|579 ug Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
391391|NCT00460811|O3|Outcome|290 ug Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
391392|NCT00460811|O2|Outcome|145 ug Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
391393|NCT00460811|O1|Outcome|72 ug Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
391394|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
391395|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
391396|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
391397|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
391398|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
391399|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
391400|NCT00460811|O4|Outcome|579 ug Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
391401|NCT00460811|O3|Outcome|290 ug Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
391402|NCT00460811|O2|Outcome|145 ug Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
391403|NCT00460811|O1|Outcome|72 ug Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
391404|NCT00460811|E5|Reported Event|Matching Placebo|Dose-matched placebo, oral administration, once per day
391405|NCT00460811|E4|Reported Event|579 µg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
391406|NCT00460811|E3|Reported Event|290 µg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
391407|NCT00460811|E2|Reported Event|145 µg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
391408|NCT00460811|E1|Reported Event|72 µg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
391409|NCT00460993|B3|Baseline|Total|Total of all reporting groups
391410|NCT00460993|B2|Baseline|Group 2|"Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention.
Weeks 3 and 4 this Placebo group crosses over to active drug. 1 mg week 3 increasing to 2mg week 4 if sleep efficiency does not improve."
391411|NCT00460993|B1|Baseline|Group 1|Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration.
391412|NCT00460993|P2|Participant Flow|Group 2|Placebo during phase 1, then active drug phase 2. One placebo for 6 days
391413|NCT00460993|P1|Participant Flow|Group 1|Active drug during phase 1, then placebo during phase 2. Lunesta Active drug (eszopiclone) 1 mg for 3 days. If sleep efficiency does not improve in 3 three day, dose increases to 2 mg for the next three days of active drug administration.
391414|NCT00460993|O2|Outcome|Group 2|Placebo pill in phase 1, then Active drug given in phase 2. One placebo pill for 6 days
391415|NCT00460993|O1|Outcome|Group 1|Active drug given in phase 1, then Placebo pill in phase 2. Lunesta Active drug (eszopiclone) 1 mg during three days of active drug. If sleep efficiency does not improve doses increases to 2 mg for the next three days of active drug administration.
391416|NCT00460993|E2|Reported Event|Group 2|Placebo pill given in phase 1, then active drug give in phase 2. One placebo pill for 6 days.
391417|NCT00460993|E1|Reported Event|Group 1|Active drug given in phase 1, then placebo pill given in phase 2.
391418|NCT00461032|B3|Baseline|Total|Total of all reporting groups
391419|NCT00461032|B2|Baseline|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
391420|NCT00461032|B1|Baseline|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
391421|NCT00461032|P2|Participant Flow|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
391422|NCT00461032|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
391423|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
391424|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
391425|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
421245|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
391426|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
391640|NCT00461292|P2|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
391427|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
391428|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
391429|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
391430|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
391431|NCT00461032|E2|Reported Event|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
391432|NCT00461032|E1|Reported Event|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
391433|NCT00461097|B3|Baseline|Total|Total of all reporting groups
391434|NCT00461097|B2|Baseline|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
391435|NCT00461097|B1|Baseline|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
391436|NCT00461097|P2|Participant Flow|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
391437|NCT00461097|P1|Participant Flow|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
391438|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
391439|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
391463|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
391630|NCT00461253|P1|Participant Flow|Cases|Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
391641|NCT00461292|P1|Participant Flow|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
391642|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
391440|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
391441|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
391442|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
391443|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
391444|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
391445|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
391446|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
391464|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
391465|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
391631|NCT00461253|O2|Outcome|Cu-IUD|Women who currently or ever used a copper IUDs at time of breast cancer diagnosis
391447|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
391448|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
391449|NCT00461097|E3|Reported Event|Egg Oral Immunotherapy (OIT), 2-4 Years|"Subjects who failed the 1st or 2nd 10 gm OFC at month 22 or year 2 continue on their egg OIT maintenance dose of 2 gm/day of egg white solid (EWS) or are allowed to attempt escalation up to 2 gm/day for the remainder of the study. Subjects who are not considered tolerant may have a 10 gm OFC at year 3 and year 4 to assess desensitization. Subjects who pass the 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
Note: The total number of subjects assessed for non-systematic adverse events was 36 (subjects with post 2-year follow-up) and for systematic adverse events was 22 (subjects with post 2-year dosing)."
391450|NCT00461097|E2|Reported Event|Placebo, 0-2 Years|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
391451|NCT00461097|E1|Reported Event|Egg Oral Immunotherapy (OIT), 0-2 Years|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day. A 10 gm OFC to identify desensitized [1] subjects occurs at month 22. Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC at year 2. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
391452|NCT00461123|B3|Baseline|Total|Total of all reporting groups
391453|NCT00461123|B2|Baseline|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
391454|NCT00461123|B1|Baseline|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
391455|NCT00461123|P2|Participant Flow|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
391456|NCT00461123|P1|Participant Flow|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
391457|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
391458|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
391459|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
391460|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
391461|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
391462|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
391466|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
391467|NCT00461123|E2|Reported Event|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
391468|NCT00461123|E1|Reported Event|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
391469|NCT00454987|B4|Baseline|Total|Total of all reporting groups
391470|NCT00454987|B3|Baseline|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391471|NCT00454987|B2|Baseline|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391472|NCT00454987|B1|Baseline|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391473|NCT00454987|P3|Participant Flow|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391474|NCT00454987|P2|Participant Flow|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391475|NCT00454987|P1|Participant Flow|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391476|NCT00454987|O3|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391477|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391478|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391479|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391480|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391481|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391482|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391483|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391484|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391485|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391486|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391487|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391488|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391489|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
421246|NCT00540124|O1|Outcome|Placebo|by mouth once a day
391490|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391491|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391492|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391493|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391494|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391495|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391496|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391497|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391498|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391499|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391500|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391501|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391502|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391503|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391504|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391505|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391506|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391507|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391508|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391509|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391510|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391511|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391512|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391632|NCT00461253|O1|Outcome|LNG IUD|Women who currently or ever used a LNG IUDs (Mirena) at time of breast cancer diagnosis
391513|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391514|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391515|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391516|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391517|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391518|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391519|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391520|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391521|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391522|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391523|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391524|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391525|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391526|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391527|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391528|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391529|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391530|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391531|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391532|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391533|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391534|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391535|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391536|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391537|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391538|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391539|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391540|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391541|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391542|NCT00454987|E3|Reported Event|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391543|NCT00454987|E2|Reported Event|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391544|NCT00454987|E1|Reported Event|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
391545|NCT00455013|B4|Baseline|Total|Total of all reporting groups
391546|NCT00455013|B3|Baseline|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391547|NCT00455013|B2|Baseline|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391548|NCT00455013|B1|Baseline|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391549|NCT00455013|P3|Participant Flow|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF 1g BID. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1, 2, 3, 4 up to maximum dose of 6 mg/kg.
391550|NCT00455013|P2|Participant Flow|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 nanograms per milliliter (ng/mL) for first 6 months, followed by 5 - 10 ng/mL until 12 months. Participants were allowed to switch from sirolimus to MMF. Background immunosuppressive medications: methylprednisolone was administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4, up to maximum dose of 6 mg/kg.
391551|NCT00455013|P1|Participant Flow|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; intravenous infusion (IV) belatacept: 10 milligram per kilogram of weight (mg/kg) Day 1 (day of transplant) and Day 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF (mycophenolate mofetil) 1g twice daily(BID). Participants were allowed to switch from MMF to sirolimus. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1 (day of transplant), 2, 3, 4, up to maximum dose of 6 mg/kg.
391552|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391553|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391554|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391555|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391556|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391557|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391558|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391559|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391560|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391561|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391562|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391563|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391564|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391565|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391566|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391567|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391568|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391627|NCT00461253|B2|Baseline|Controls|Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
391633|NCT00461253|E2|Reported Event|Cu-IUD|Users of copper IUDs
391569|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391570|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391571|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391572|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391573|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391574|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391575|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391576|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391577|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391578|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391579|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391580|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391581|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391582|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391583|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391628|NCT00461253|B1|Baseline|Cases|Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
391634|NCT00461253|E1|Reported Event|LNG IUD|Users of LNG IUDs (Mirena)
391584|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391585|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391586|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391587|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391588|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391589|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391590|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391591|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391592|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391593|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391594|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391595|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391596|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391597|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391598|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391629|NCT00461253|P2|Participant Flow|Controls|Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
391635|NCT00461292|B4|Baseline|Total|Total of all reporting groups
391599|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391600|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391601|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391602|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391603|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391604|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391605|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391606|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391607|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391608|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391609|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
391610|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
391611|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
391612|NCT00455013|E3|Reported Event|Tacrolimus - MMF|
391613|NCT00455013|E2|Reported Event|Belatacept - SIRO|
391614|NCT00455013|E1|Reported Event|Belatacept - MMF|
391615|NCT00461175|B3|Baseline|Total|Total of all reporting groups
391616|NCT00461175|B2|Baseline|Copper IUD|New users of Copper IUD
391617|NCT00461175|B1|Baseline|LNG IUS|New users of Mirena® IUS
391618|NCT00461175|P2|Participant Flow|Copper IUD|New users of Copper IUD
391619|NCT00461175|P1|Participant Flow|LNG IUS|New users of Mirena® IUS
391620|NCT00461175|O2|Outcome|Copper IUD|New users of Copper IUD
391621|NCT00461175|O1|Outcome|LNG IUS|New users of Mirena® IUS
391622|NCT00461175|O2|Outcome|Copper IUD|New users of Copper IUD
391623|NCT00461175|O1|Outcome|LNG IUS|New users of Mirena® IUS
391624|NCT00461175|E2|Reported Event|Copper IUD|New users of Copper IUD
391625|NCT00461175|E1|Reported Event|LNG IUS|New users of Mirena® IUS
391626|NCT00461253|B3|Baseline|Total|Total of all reporting groups
391644|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
391645|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
391646|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
391647|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
391648|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
391649|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
391650|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
391651|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
391652|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
391653|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
391654|NCT00461292|E3|Reported Event|Placebo|Normal saline (placebo)
391655|NCT00461292|E2|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
391656|NCT00461292|E1|Reported Event|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
391657|NCT00461305|B3|Baseline|Total|Total of all reporting groups
391658|NCT00461305|B2|Baseline|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391659|NCT00461305|B1|Baseline|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391660|NCT00461305|P2|Participant Flow|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391661|NCT00461305|P1|Participant Flow|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391662|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391663|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391664|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391665|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391666|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391667|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391668|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391669|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391670|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391671|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391672|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391673|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391674|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391675|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391676|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391677|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391678|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391679|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
392877|NCT00464334|B7|Baseline|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
391680|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391916|NCT00462072|E2|Reported Event|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
391681|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391682|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391683|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391684|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391685|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391686|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391687|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391688|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391689|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391690|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391691|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391692|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391693|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391694|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391695|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391696|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391697|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391698|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391699|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391700|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391701|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391702|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391703|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391704|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391705|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391706|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391707|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391708|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391795|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391709|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391710|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391711|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391712|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391713|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391714|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391715|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391716|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391717|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391718|NCT00461305|E2|Reported Event|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
391719|NCT00461305|E1|Reported Event|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
391720|NCT00461331|B1|Baseline|Entire Study Population|These are the characteristics of the entire study population.
391721|NCT00461331|P2|Participant Flow|Lispro First, Washout, Then Aspart|Patients used Lispro Insulin for up to 100 hours, then entered a two week wash out period, then used Aspart insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.
391722|NCT00461331|P1|Participant Flow|Aspart First, Washout, Then Lispro|Patients used Aspart Insulin for up to 100 hours, then entered a two week wash out period, then used Lispro insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.
391723|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
391724|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
391725|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
391726|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
391727|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro first in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
391728|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
391796|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
392878|NCT00464334|B6|Baseline|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
391800|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391729|NCT00461331|E2|Reported Event|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
391730|NCT00461331|E1|Reported Event|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
391731|NCT00461500|B3|Baseline|Total|Total of all reporting groups
391732|NCT00461500|B2|Baseline|FP 100: Fluticasone Propionate.|Analysis population used in this arm is ITT population(Randomised subjects who received at least one dose of study drug and with evaluation for at least one efficacy criteria).
391733|NCT00461500|B1|Baseline|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|Analysis population used in this arm is ITT (intent-to-treat) population (Randomised subjects who received at least one dose of study drug and with evaluation for at least one efficacy criteria).
391734|NCT00461500|P2|Participant Flow|FP (Fluticasone Propionate)100|Analysis population are all randomized subjects in this arm. 100ug - one inhalation twice daily
391735|NCT00461500|P1|Participant Flow|SFC (Salmeterol Xinafoate/Fluticasone Propionate Combination)|Analysis population are all randomized subjects in this arm. 50/100ug - one inhalation twice daily
391736|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391737|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391738|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391739|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391740|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391741|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391742|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391743|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391744|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391745|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391746|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391747|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391748|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391749|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391750|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391751|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391752|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391753|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391754|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391755|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391756|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391757|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391758|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391759|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391760|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391761|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391762|NCT00461500|E2|Reported Event|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
391763|NCT00461500|E1|Reported Event|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
391764|NCT00461513|B3|Baseline|Total|Total of all reporting groups
391765|NCT00461513|B2|Baseline|Usual Care Group|Baseline characteristics of patients who enrolled and were randomized to the Usual Care Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months).Therefore the total number completed in the Usual Care Arm was 172, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 197 patients.
391766|NCT00461513|B1|Baseline|Intervention Group|Baseline characteristics of patients who enrolled and were randomized to the Intervention Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months). Therefore the total number completed in the Intervention Arm was 165, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 187 patients.
391797|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391798|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391799|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
392879|NCT00464334|B5|Baseline|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
391767|NCT00461513|P2|Participant Flow|Usual Care|Patients randomized to the usual care arm continued to receive care at the discretion of their regular VA providers (for a given patient, this could include cardiology specialty care in addition to PCP care, participation in site-specific CHF programs such as CHF patient education classes, etc.), in direct continuity with the care they were receiving prior to enrollment. Patients in the usual care group were given information sheets that outlined self-care for CHF, and provided with a scale if needed at the enrollment visit. Patients in the usual care group had the same amount of interaction with the study team as the intervention patients (i.e. complete questionnaires at the same frequency; have the same study visits). PCPs of usual care patients were notified of the results of all screening studies (patient survey results, lab tests).
391768|NCT00461513|P1|Participant Flow|Intervention|The PCDM intervention included evaluation of CHF care by the collaborative care (CC) team with treatment recommendations based on current ACC/AHA clinical practice guidelines, telemonitoring, and screening and treatment for comorbid depression. The CC team at each site included a primary care provider, cardiologist and psychiatrist, as well as nurse and pharmacist. For each intervention patient, there was initial assessment of care following the enrollment visit. Each intervention patient was re-reviewed by the CC team a minimum of 2 additional times (at 6-weeks and 6 months). In addition, patients had daily telemonitoring, and their care was reviewed if the telemonitoring data suggested clinical deterioration.
391769|NCT00461513|O2|Outcome|Usual Care|
391770|NCT00461513|O1|Outcome|Intervention|
391771|NCT00461513|E2|Reported Event|Usual Care|
391772|NCT00461513|E1|Reported Event|Intervention|
391773|NCT00461851|B1|Baseline|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone
Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.
Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.
Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
391774|NCT00461851|P1|Participant Flow|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone
Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.
Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.
Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
391775|NCT00461851|O1|Outcome|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone
Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.
Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.
Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
391776|NCT00461851|E1|Reported Event|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone
Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.
Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.
Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
391777|NCT00461981|B3|Baseline|Total|Total of all reporting groups
391778|NCT00461981|B2|Baseline|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391779|NCT00461981|B1|Baseline|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391780|NCT00461981|P2|Participant Flow|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391781|NCT00461981|P1|Participant Flow|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391782|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391783|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391784|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391785|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391786|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391787|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391788|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391789|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391790|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391791|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391792|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391793|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391794|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391801|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391802|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391803|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391804|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391805|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391806|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391807|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391808|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391809|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391810|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391811|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391812|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391813|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391814|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391815|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391816|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391817|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391818|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391819|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391820|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391821|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391822|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391823|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391824|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391825|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391826|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391827|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391828|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391829|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391830|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391831|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391832|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391833|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391834|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391835|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391836|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391837|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391838|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391839|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391840|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391841|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391842|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391843|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391844|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391845|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391846|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391847|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391848|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391849|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391850|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391851|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391852|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391853|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391854|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391855|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391856|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391857|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391858|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391859|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391860|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391861|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391862|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391863|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391864|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391865|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391866|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391867|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391868|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391869|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391870|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391871|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391872|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391873|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391874|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391875|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391876|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391877|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391878|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391879|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391880|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391881|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391882|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391883|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391884|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391885|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391886|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391887|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391888|NCT00461981|E2|Reported Event|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
391889|NCT00461981|E1|Reported Event|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
391890|NCT00462020|B3|Baseline|Total|Total of all reporting groups
391891|NCT00462020|B2|Baseline|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
391892|NCT00462020|B1|Baseline|IV Only|5 days of IV antibiotics after appendectomy
391893|NCT00462020|P2|Participant Flow|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
391894|NCT00462020|P1|Participant Flow|IV Only|5 days of IV antibiotics after appendectomy
391895|NCT00462020|O2|Outcome|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
391896|NCT00462020|O1|Outcome|IV Only|5 days of IV antibiotics after appendectomy
391897|NCT00462020|E2|Reported Event|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
391898|NCT00462020|E1|Reported Event|IV Only|5 days of IV antibiotics after appendectomy
391899|NCT00462072|B4|Baseline|Total|Total of all reporting groups
391900|NCT00462072|B3|Baseline|Psoriasis (Ps)|Ps subjects starting Infliximab
391901|NCT00462072|B2|Baseline|Psoriatic Arthritis (PsA)|PsA subjects starting Infliximab
391902|NCT00462072|B1|Baseline|Rheumatoid Arthritis (RA)|RA subject starting Infliximab
391903|NCT00462072|P3|Participant Flow|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
391904|NCT00462072|P2|Participant Flow|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
391905|NCT00462072|P1|Participant Flow|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
391906|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
391907|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
391908|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
391909|NCT00462072|O2|Outcome|Rheumatoid Arthritis|RA subjects taking Infliximab as part of their standard of care.
391910|NCT00462072|O1|Outcome|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
391911|NCT00462072|O2|Outcome|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
391912|NCT00462072|O1|Outcome|Psoriariatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
391913|NCT00462072|O2|Outcome|Rheumatoid Arthritis (RA)|RA subjects starting Infliximab as part of their standard of care.
391914|NCT00462072|O1|Outcome|Psoriatic Arthritis (PsA)|PsA subjects starting Infliximab as part of their standard of care.
421247|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
391915|NCT00462072|E3|Reported Event|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
445030|NCT00591760|E2|Reported Event|Control|Optimal CHF treatment
391917|NCT00462072|E1|Reported Event|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
391918|NCT00462228|B1|Baseline|Overall Study|All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design.
391919|NCT00462228|P1|Participant Flow|Overall Study|All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design. Five subjects were randomized to begin the study by taking memantine and crossover to placebo; seven subjects began with placebo and crossed over to memantine.
391920|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
391921|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
391922|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
391923|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
391924|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
391925|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
391926|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
391927|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
391928|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
391929|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
391930|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
391931|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
391932|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
391933|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
391934|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
391935|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
391936|NCT00462228|E3|Reported Event|No Treatment (Washout)|All 11 subjects completed a 4 week washout between memantine and placebo arms and a 4 week washout at the end of the study.
391937|NCT00462228|E2|Reported Event|Memantine|All 11 subjects completed 12 weeks of memantine treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
391938|NCT00462228|E1|Reported Event|Placebo|All 11 subjects completed 12 weeks of placebo treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
391939|NCT00462280|B5|Baseline|Total|Total of all reporting groups
391940|NCT00462280|B4|Baseline|One Large Nevi Group-Placebo|"Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391941|NCT00462280|B3|Baseline|One Large Nevi Group-Lovastatin|"Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391942|NCT00462280|B2|Baseline|Two Matched Nevi Group-Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391943|NCT00462280|B1|Baseline|Two Matched Nevi Group-Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391944|NCT00462280|P4|Participant Flow|One Large Nevi Group - Placebo|"Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391945|NCT00462280|P3|Participant Flow|One Large Nevi Group - Lovastatin|"Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391946|NCT00462280|P2|Participant Flow|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391947|NCT00462280|P1|Participant Flow|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391948|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391949|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
392020|NCT00462332|P2|Participant Flow|Low Risk Patients|Category of risk will be defined according to biological features.
392880|NCT00464334|B4|Baseline|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
391990|NCT00462280|O2|Outcome|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391950|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391951|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391952|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391953|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391954|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391955|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391956|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391957|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391958|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391959|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391960|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391961|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391962|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391963|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391964|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391965|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391966|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391967|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391968|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391969|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
392021|NCT00462332|P1|Participant Flow|High Risk Patientes|Category of risk will be defined according to biological features.
391970|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391971|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391972|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391973|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391974|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391975|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391976|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391977|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391978|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391979|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391980|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391981|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391982|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391983|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391984|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391985|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391986|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391987|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391988|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391989|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
392022|NCT00462332|O2|Outcome|Low Risk Patients|Category of risk will be defined according to biological features.
421248|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
391991|NCT00462280|O1|Outcome|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391992|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391993|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391994|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391995|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391996|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391997|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm.
Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391998|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
391999|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
392000|NCT00462280|O2|Outcome|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
392001|NCT00462280|O1|Outcome|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
392002|NCT00462280|E4|Reported Event|One Large Nevi Group-Placebo|Patients who have one large nevi receive placebo PO QD for up to 6 months
392003|NCT00462280|E3|Reported Event|One Large Nevi Group-Lovastatin|Patients who have one large nevi received lovastatin PO QD for up to 6 months
392004|NCT00462280|E2|Reported Event|Two Matched Nevi Group-Placebo|"Patients receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
392005|NCT00462280|E1|Reported Event|Two Matched Nevi Group-Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
lovastatin: Given PO
biopsy: Correlative studies
laboratory biomarker analysis: Correlative studies"
392006|NCT00462306|B3|Baseline|Total|Total of all reporting groups
392007|NCT00462306|B2|Baseline|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
392008|NCT00462306|B1|Baseline|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
392009|NCT00462306|P2|Participant Flow|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
392010|NCT00462306|P1|Participant Flow|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
392011|NCT00462306|O2|Outcome|Negative Berlin Questionnaires|Pregnant Women with Results of Berlin Questionnaire not Indicative of Sleep Disordered Breathing
392012|NCT00462306|O1|Outcome|Positive Berlin Questionaires|Pregnant Women with Berlin Questionnaire Responses Indicative of Sleep Disordered Breathing
392013|NCT00462306|O2|Outcome|Non-Pregnant Women|Non-pregnant women undergoing a surgical procedure
392014|NCT00462306|O1|Outcome|Pregnant Women|
392015|NCT00462306|E2|Reported Event|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
392016|NCT00462306|E1|Reported Event|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
392017|NCT00462332|B3|Baseline|Total|Total of all reporting groups
392018|NCT00462332|B2|Baseline|Low Risk Patients|Category of risk will be defined according to biological features.
392019|NCT00462332|B1|Baseline|High Risk Patientes|Category of risk will be defined according to biological features.
392881|NCT00464334|B3|Baseline|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
392023|NCT00462332|O1|Outcome|High Risk Patientes|Category of risk will be defined according to biological features.
392024|NCT00462332|O2|Outcome|High Risk Patients|
392025|NCT00462332|O1|Outcome|Low Risk Patients|
392026|NCT00462332|E2|Reported Event|Low Risk Patients|Category of risk will be defined according to biological features.
392027|NCT00462332|E1|Reported Event|High Risk Patientes|Category of risk will be defined according to biological features.
392028|NCT00462345|B1|Baseline|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392029|NCT00462345|P1|Participant Flow|Rituximab, Methotrexate|Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate at a stable dose of greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392030|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392031|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392032|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392033|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392034|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392035|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392036|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392037|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392038|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392084|NCT00462462|O1|Outcome|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel and for whom lesional volume measurements were available at screening and at study end
392039|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392040|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392041|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392042|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392043|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392044|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392045|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392046|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392047|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392048|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392049|NCT00462345|E1|Reported Event|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
392050|NCT00462384|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
392082|NCT00462462|P1|Participant Flow|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
392083|NCT00462462|O2|Outcome|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol and for whom lesional volume measurements were available at screening and at study end
392051|NCT00462384|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
392052|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
392053|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
392054|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
392055|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
392056|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
392057|NCT00462384|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
392058|NCT00462423|B1|Baseline|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin
Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
392059|NCT00462423|P1|Participant Flow|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin
Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
392060|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin
Avastin: Avastin 10 mg/kg IV every 2 weeks (without rest period).
Abraxane: Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle."
392061|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin
Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
392062|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin
Avastin: Avastin 10 mg/kg IV every 2 weeks (without rest period).
Abraxane: Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle."
392063|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin
Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
392064|NCT00462423|E1|Reported Event|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin
Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
392065|NCT00462449|B3|Baseline|Total|Total of all reporting groups
392066|NCT00462449|B2|Baseline|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
392067|NCT00462449|B1|Baseline|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
392068|NCT00462449|P2|Participant Flow|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
392069|NCT00462449|P1|Participant Flow|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
392070|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
392071|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
392072|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
392073|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
392074|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
392075|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
392076|NCT00462449|E2|Reported Event|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
392077|NCT00462449|E1|Reported Event|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
392078|NCT00462462|B3|Baseline|Total|Total of all reporting groups
392079|NCT00462462|B2|Baseline|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
392080|NCT00462462|B1|Baseline|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
392081|NCT00462462|P2|Participant Flow|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
392085|NCT00462462|O2|Outcome|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol and who had blood samples just before and during infusion procedure (one patient who received Absolute Ethanol was not sampled during infusion procedure).
392086|NCT00462462|O1|Outcome|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel and who had blood samples just before and during infusion procedure.
392087|NCT00462462|E2|Reported Event|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
392088|NCT00462462|E1|Reported Event|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
392089|NCT00462501|B1|Baseline|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
392090|NCT00462501|P1|Participant Flow|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
392091|NCT00462501|O1|Outcome|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
392092|NCT00462501|E1|Reported Event|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
392093|NCT00462605|B1|Baseline|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.
entinostat: Given PO
sargramostim: Given SC"
392094|NCT00462605|P1|Participant Flow|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.
entinostat: Given PO
sargramostim: Given SC"
392095|NCT00462605|O1|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.
entinostat: Given PO
sargramostim: Given SC"
392120|NCT00462644|E2|Reported Event|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
421249|NCT00540124|O1|Outcome|Placebo|by mouth once a day
392121|NCT00462644|E1|Reported Event|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
392096|NCT00462605|O1|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.
entinostat: Given PO
sargramostim: Given SC"
392097|NCT00462605|O1|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.
entinostat: Given PO
sargramostim: Given SC"
392098|NCT00462605|O1|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.
entinostat: Given PO
sargramostim: Given SC"
392099|NCT00462605|O1|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.
entinostat: Given PO
sargramostim: Given SC"
392100|NCT00462605|E1|Reported Event|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.
entinostat: Given PO
sargramostim: Given SC"
392101|NCT00462644|B3|Baseline|Total|Total of all reporting groups
392102|NCT00462644|B2|Baseline|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
392103|NCT00462644|B1|Baseline|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
392104|NCT00462644|P2|Participant Flow|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
392105|NCT00462644|P1|Participant Flow|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
392106|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
392107|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
392108|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
392109|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
392110|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
392111|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
392112|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
392113|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
392114|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
392115|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
392116|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
392117|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
392118|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
392119|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
392188|NCT00462748|E2|Reported Event|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
392123|NCT00462670|B2|Baseline|OPC-41061|15mg of OPC-41061 per day for 7days p.o. administration
392124|NCT00462670|B1|Baseline|Placebo|0 mg of OPC-41061 per day for 7days p.o. administration
392125|NCT00462670|P2|Participant Flow|OPC-41061 15mg|"15mg OPC-41061
OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
392126|NCT00462670|P1|Participant Flow|Placebo|"0mg
OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
392127|NCT00462670|O2|Outcome|OPC-41061 15mg|"15mg OPC-41061
OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
392128|NCT00462670|O1|Outcome|Placebo|"0mg
OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
392129|NCT00462670|O2|Outcome|OPC-41061 15mg|"15mg OPC-41061
OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
392130|NCT00462670|O1|Outcome|Placebo|"0mg
OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
392131|NCT00462670|E2|Reported Event|OPC-41061 15mg|15 mg of OPC-41061 per day for 7days p.o. administration
392132|NCT00462670|E1|Reported Event|Placebo|0 mg of OPC-41061 per day for 7days p.o. administration
392133|NCT00462709|B1|Baseline|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
392134|NCT00462709|P1|Participant Flow|Open-label C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV) every 3 to 7 days.
392135|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
392136|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
392137|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
392138|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
392139|NCT00462709|E1|Reported Event|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
392140|NCT00462722|B4|Baseline|Total|Total of all reporting groups
392141|NCT00462722|B3|Baseline|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392142|NCT00462722|B2|Baseline|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392143|NCT00462722|B1|Baseline|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392144|NCT00462722|P3|Participant Flow|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392145|NCT00462722|P2|Participant Flow|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392146|NCT00462722|P1|Participant Flow|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392147|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392148|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392149|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392189|NCT00462748|E1|Reported Event|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
392190|NCT00462826|B1|Baseline|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
392191|NCT00462826|P1|Participant Flow|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
392150|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392151|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392152|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392153|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392154|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392155|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392156|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392157|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392158|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392159|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392160|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392161|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392162|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392163|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392164|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392400|NCT00463229|B3|Baseline|Total|Total of all reporting groups
392165|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392166|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392167|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392168|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392169|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392170|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392171|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392172|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392173|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392174|NCT00462722|E3|Reported Event|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392175|NCT00462722|E2|Reported Event|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise
Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392176|NCT00462722|E1|Reported Event|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise
Placebo: with each exercise session (up to 5 days per week) for 9 months
musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
392177|NCT00462748|B4|Baseline|Total|Total of all reporting groups
392178|NCT00462748|B3|Baseline|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
392179|NCT00462748|B2|Baseline|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
392180|NCT00462748|B1|Baseline|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
392181|NCT00462748|P3|Participant Flow|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
392182|NCT00462748|P2|Participant Flow|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
392183|NCT00462748|P1|Participant Flow|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
392184|NCT00462748|O3|Outcome|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
392185|NCT00462748|O2|Outcome|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
392186|NCT00462748|O1|Outcome|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
392187|NCT00462748|E3|Reported Event|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
392192|NCT00462826|O1|Outcome|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
392193|NCT00462826|E1|Reported Event|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
392194|NCT00462839|B3|Baseline|Total|Total of all reporting groups
392195|NCT00462839|B2|Baseline|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392196|NCT00462839|B1|Baseline|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392197|NCT00462839|P2|Participant Flow|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392198|NCT00462839|P1|Participant Flow|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392199|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392200|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392201|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392202|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392203|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392204|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392205|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392206|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392207|NCT00462839|E2|Reported Event|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392208|NCT00462839|E1|Reported Event|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
392209|NCT00462865|B1|Baseline|Treatment|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.
Doses to be administered:
Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1
Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
392210|NCT00462865|P1|Participant Flow|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.
Doses to be administered:
Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1
Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
392211|NCT00462865|O1|Outcome|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles that lead to patients being taken off study.
Doses to be administered:
Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1
Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
392882|NCT00464334|B2|Baseline|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
392693|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
392694|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
392212|NCT00462865|E1|Reported Event|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.
Doses to be administered:
Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1
Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
392213|NCT00462917|B5|Baseline|Total|Total of all reporting groups
392214|NCT00462917|B4|Baseline|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392215|NCT00462917|B3|Baseline|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session."
392216|NCT00462917|B2|Baseline|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392217|NCT00462917|B1|Baseline|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session."
392218|NCT00462917|P4|Participant Flow|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392219|NCT00462917|P3|Participant Flow|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session."
392220|NCT00462917|P2|Participant Flow|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392221|NCT00462917|P1|Participant Flow|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session."
392222|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392223|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session."
392224|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392225|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session."
392226|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392227|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session."
392401|NCT00463229|B2|Baseline|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
392228|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392229|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session."
392230|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392231|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session."
392232|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392233|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session."
392234|NCT00462917|E4|Reported Event|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392235|NCT00462917|E3|Reported Event|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session."
392236|NCT00462917|E2|Reported Event|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session."
392237|NCT00462917|E1|Reported Event|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session."
392238|NCT00462943|B4|Baseline|Total|Total of all reporting groups
392239|NCT00462943|B3|Baseline|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392240|NCT00462943|B2|Baseline|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392241|NCT00462943|B1|Baseline|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392242|NCT00462943|P3|Participant Flow|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392243|NCT00462943|P2|Participant Flow|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392244|NCT00462943|P1|Participant Flow|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392245|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392246|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392247|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392248|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392249|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392250|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392251|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392252|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392253|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392254|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392255|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392256|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392257|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392883|NCT00464334|B1|Baseline|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
392258|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392259|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392260|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392261|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392262|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392263|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392264|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392265|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392266|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392267|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392268|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392269|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392270|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392271|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392685|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
392272|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392273|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392274|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392275|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392276|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392277|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392278|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392279|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392280|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392281|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392282|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392283|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392284|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392285|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392686|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
392687|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
392286|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392287|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392288|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392289|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392290|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392291|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392292|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392293|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392294|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392295|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392296|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392297|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392298|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392299|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392688|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
392300|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392301|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392302|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392303|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392304|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392305|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392306|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392307|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392308|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392309|NCT00462943|E1|Reported Event|Omacetaxine|Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
392310|NCT00462982|B1|Baseline|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
392311|NCT00462982|P1|Participant Flow|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
392312|NCT00462982|O1|Outcome|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
392313|NCT00462982|E1|Reported Event|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
392314|NCT00463047|B1|Baseline|Total Number of Patients|Fentanyl Buccal Tablets (FBT) and Immediate-Release Oxycodone crossover. The total number of patients (323) reflect the number that were enrolled to participate in the study prior to the first titration period. Three subjects withdrew before receiving any study drug so they are not listed as being assigned to either dosing arm in the titration studies, leaving only 320 subjects who were evenly divided between the two groups.
392315|NCT00463047|P2|Participant Flow|Immediate-Release Oxycodone First FBT Second|Patients were randomly assigned 1:1 to either titrate FBT during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased in 200 mcg increments for FBT and 15 mg increments for oxycodone. The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
392571|NCT00463567|O4|Outcome|Placebo|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392316|NCT00463047|P1|Participant Flow|FBT First Immediate Release Oxycodone Second|Patients were randomized 1:1 to titrate Fentanyl Buccal Tablet (FBT) during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased in 200 mcg increments for FBT and 15 mg increments for oxycodone. The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
392317|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392318|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392319|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392320|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392321|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392322|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392323|NCT00463047|O1|Outcome|Total|Includes all patients who participated in the double-blind treatment period and completed treatment.
392324|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392325|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392326|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392327|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392328|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392329|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392330|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392331|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392332|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392333|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392334|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392335|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392572|NCT00463567|O3|Outcome|Tiotropium 18 µg|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®).
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392336|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392337|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392338|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392339|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392340|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392341|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392342|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392343|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392344|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392345|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392346|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392347|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392348|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392349|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392350|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392351|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392352|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392353|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392354|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392355|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392356|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392357|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392629|NCT00463788|B3|Baseline|Total|Total of all reporting groups
392689|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
392358|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392359|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392360|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392361|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392362|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392363|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392364|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392365|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392366|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392367|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392368|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392369|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392370|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392371|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392372|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392373|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392374|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392375|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392376|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392377|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392378|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392379|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392690|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
392691|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
392380|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392381|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392382|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392383|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392384|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392385|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392386|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392387|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392388|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392389|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392390|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392391|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392392|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392393|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392394|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392395|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392396|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
392397|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
392398|NCT00463047|E2|Reported Event|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug. This arm represents all subjects who had exposure to at least one dose of immediate-release oxycodone either during the titration periods or double-blind periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone.
392399|NCT00463047|E1|Reported Event|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients. This group includes all subjects in this study who had taken at least one dose of FBT in the course of the study, including both titration periods and both double-blind treatment periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone.
392402|NCT00463229|B1|Baseline|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
392403|NCT00463229|P2|Participant Flow|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
392404|NCT00463229|P1|Participant Flow|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
392405|NCT00463229|O2|Outcome|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
392406|NCT00463229|O1|Outcome|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
392407|NCT00463229|E2|Reported Event|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
392408|NCT00463229|E1|Reported Event|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
392409|NCT00463346|B3|Baseline|Total|Total of all reporting groups
392410|NCT00463346|B2|Baseline|Placebo|Placebo dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
392411|NCT00463346|B1|Baseline|Acamprosate|Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
392412|NCT00463346|P2|Participant Flow|Placebo|dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
392413|NCT00463346|P1|Participant Flow|Acamprosate|Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
392414|NCT00463346|O2|Outcome|Placebo|placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
392415|NCT00463346|O1|Outcome|Acamprosate|"Acamprosate
Acamprosate: Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules."
392416|NCT00463346|O2|Outcome|Placebo|Placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
392417|NCT00463346|O1|Outcome|Acamprosate|"Acamprosate
1998 mg TID Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules."
392418|NCT00463346|E2|Reported Event|Placebo|placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
392419|NCT00463346|E1|Reported Event|Acamprosate|Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
392420|NCT00463385|B5|Baseline|Total|Total of all reporting groups
392421|NCT00463385|B4|Baseline|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392422|NCT00463385|B3|Baseline|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392423|NCT00463385|B2|Baseline|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
421250|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
392424|NCT00463385|B1|Baseline|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392425|NCT00463385|P4|Participant Flow|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392426|NCT00463385|P3|Participant Flow|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392427|NCT00463385|P2|Participant Flow|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392428|NCT00463385|P1|Participant Flow|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392429|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392430|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392431|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392432|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392433|NCT00463385|O8|Outcome|Pomalidomide 0.5 mg + Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392434|NCT00463385|O7|Outcome|Pomalidomide 2 mg + Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392435|NCT00463385|O6|Outcome|Pomalidomide 2 mg, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392436|NCT00463385|O5|Outcome|Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392437|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392438|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392439|NCT00463385|O2|Outcome|Pomalidomide 2 mg, PositiveJAK2|"Participants with a positive JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392440|NCT00463385|O1|Outcome|Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392441|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392442|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392443|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392444|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392445|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392446|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392447|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392448|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392495|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392692|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
392449|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392450|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392451|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392452|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392453|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392454|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392455|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392456|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392457|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392458|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392459|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392460|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392461|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392462|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392463|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392464|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392465|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392466|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392467|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392468|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392469|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392470|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392471|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392472|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392473|NCT00463385|E4|Reported Event|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392474|NCT00463385|E3|Reported Event|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392475|NCT00463385|E2|Reported Event|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
392476|NCT00463385|E1|Reported Event|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
392477|NCT00463437|B5|Baseline|Total|Total of all reporting groups
392478|NCT00463437|B4|Baseline|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392479|NCT00463437|B3|Baseline|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392480|NCT00463437|B2|Baseline|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392481|NCT00463437|B1|Baseline|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392482|NCT00463437|P4|Participant Flow|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392483|NCT00463437|P3|Participant Flow|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392484|NCT00463437|P2|Participant Flow|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392485|NCT00463437|P1|Participant Flow|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392486|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392487|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392488|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392489|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392490|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392491|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392492|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392493|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392494|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
421251|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
392496|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392497|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392498|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392499|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392500|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392501|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392502|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392503|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392504|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392505|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392506|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392507|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392508|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392509|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392510|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392511|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392512|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392513|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392514|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392515|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392516|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392517|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392518|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392519|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392520|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392521|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392522|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392523|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392524|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392525|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392526|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392527|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392528|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392529|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392530|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392531|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392532|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392533|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392534|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392535|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392536|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392537|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392538|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392539|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392540|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392541|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392542|NCT00463437|E4|Reported Event|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392543|NCT00463437|E3|Reported Event|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
392544|NCT00463437|E2|Reported Event|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
392545|NCT00463437|E1|Reported Event|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
392546|NCT00463567|B8|Baseline|Total|Total of all reporting groups
392547|NCT00463567|B7|Baseline|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392548|NCT00463567|B6|Baseline|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392549|NCT00463567|B5|Baseline|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392550|NCT00463567|B4|Baseline|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392551|NCT00463567|B3|Baseline|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392552|NCT00463567|B2|Baseline|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392553|NCT00463567|B1|Baseline|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392554|NCT00463567|P7|Participant Flow|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392555|NCT00463567|P6|Participant Flow|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392556|NCT00463567|P5|Participant Flow|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392557|NCT00463567|P4|Participant Flow|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392558|NCT00463567|P3|Participant Flow|Tiotropium (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392559|NCT00463567|P2|Participant Flow|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392560|NCT00463567|P1|Participant Flow|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392561|NCT00463567|O7|Outcome|Formoterol 12 µg|"In the morning, Placebo to Indacaterol delivered via SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392562|NCT00463567|O6|Outcome|Indacaterol 600 µg|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392563|NCT00463567|O5|Outcome|Indacaterol 75 µg|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392564|NCT00463567|O4|Outcome|Placebo|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392565|NCT00463567|O3|Outcome|Tiotropium 18 µg|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®).
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392566|NCT00463567|O2|Outcome|Indacaterol 300 µg|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392567|NCT00463567|O1|Outcome|Indacaterol 150 µg|"In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392568|NCT00463567|O7|Outcome|Formoterol 12 µg|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392569|NCT00463567|O6|Outcome|Indacaterol 600 µg|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392570|NCT00463567|O5|Outcome|Indacaterol 75 µg|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392573|NCT00463567|O2|Outcome|Indacaterol 300 µg|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392574|NCT00463567|O1|Outcome|Indacaterol 150 µg|"In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392575|NCT00463567|O4|Outcome|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392576|NCT00463567|O3|Outcome|Tiotropium (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392577|NCT00463567|O2|Outcome|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392578|NCT00463567|O1|Outcome|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392579|NCT00463567|O4|Outcome|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392580|NCT00463567|O3|Outcome|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392581|NCT00463567|O2|Outcome|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392582|NCT00463567|O1|Outcome|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392583|NCT00463567|E7|Reported Event|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392584|NCT00463567|E6|Reported Event|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392585|NCT00463567|E5|Reported Event|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392586|NCT00463567|E4|Reported Event|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392630|NCT00463788|B2|Baseline|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
392587|NCT00463567|E3|Reported Event|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392588|NCT00463567|E2|Reported Event|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392589|NCT00463567|E1|Reported Event|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
392590|NCT00463580|B3|Baseline|Total|Total of all reporting groups
392591|NCT00463580|B2|Baseline|Placebo|
392592|NCT00463580|B1|Baseline|Infliximab|Infliximab
392593|NCT00463580|P2|Participant Flow|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
392594|NCT00463580|P1|Participant Flow|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
392595|NCT00463580|O2|Outcome|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
392596|NCT00463580|O1|Outcome|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
392597|NCT00463580|O2|Outcome|Placebo|Normal Saline
392598|NCT00463580|O1|Outcome|Infliximab|Infliximab
392599|NCT00463580|E2|Reported Event|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
392600|NCT00463580|E1|Reported Event|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
392601|NCT00463606|B4|Baseline|Total|Total of all reporting groups
392602|NCT00463606|B3|Baseline|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
392603|NCT00463606|B2|Baseline|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
392604|NCT00463606|B1|Baseline|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392605|NCT00463606|P3|Participant Flow|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
392606|NCT00463606|P2|Participant Flow|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
392607|NCT00463606|P1|Participant Flow|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392608|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
392609|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392610|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
392611|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392612|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
392613|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392614|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
392615|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392616|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
392617|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392618|NCT00463606|O2|Outcome|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
392619|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392620|NCT00463606|O2|Outcome|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
392621|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392622|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
392623|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392624|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
392625|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392626|NCT00463606|E3|Reported Event|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
392627|NCT00463606|E2|Reported Event|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
392628|NCT00463606|E1|Reported Event|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
392631|NCT00463788|B1|Baseline|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
392632|NCT00463788|P2|Participant Flow|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
392633|NCT00463788|P1|Participant Flow|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
392634|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
392635|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
392636|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
392637|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
392638|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
392639|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
392640|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
392641|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
392642|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
392643|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
392644|NCT00463788|E3|Reported Event|Cisplatin Alone Switched to Cetuximab|On progression, participants in the cisplatin group had the option to switch to cisplatin (75 mg/m^2 IV infusion) plus cetuximab (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progressive disease was reported during the 6 cisplatin cycles or to cetuximab alone (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progression was reported after the 6 cisplatin cycles.
392645|NCT00463788|E2|Reported Event|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of progressive disease (PD), unacceptable toxicity or withdrawal of consent.
392646|NCT00463788|E1|Reported Event|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly.
392647|NCT00463801|B1|Baseline|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
392648|NCT00463801|P1|Participant Flow|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
392649|NCT00463801|O1|Outcome|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
392650|NCT00463801|E1|Reported Event|All Patients|All patients
392684|NCT00464087|P1|Participant Flow|Heparin|All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to unfractionated heparin during angioplasty and receive a minimum dose of 60 U/kg IV.
392868|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392651|NCT00463840|B1|Baseline|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:
Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;
Combined with :
5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).
Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.
Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):
Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
392652|NCT00463840|P1|Participant Flow|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:
Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;
Combined with :
5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).
Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.
Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):
Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
392653|NCT00463840|O1|Outcome|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:
Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;
Combined with :
5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).
Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.
Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):
Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
392654|NCT00463840|E1|Reported Event|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:
Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;
Combined with :
5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).
Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.
Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):
Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
392655|NCT00463866|B3|Baseline|Total|Total of all reporting groups
392656|NCT00463866|B2|Baseline|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
392657|NCT00463866|B1|Baseline|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
392658|NCT00463866|P2|Participant Flow|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
392659|NCT00463866|P1|Participant Flow|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
392660|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
392661|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
392662|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
392663|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
392664|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
392665|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
392666|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
392667|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
392668|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
392669|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
392670|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
392671|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
392672|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
392673|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
392674|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
392675|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
392676|NCT00463866|E2|Reported Event|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
392677|NCT00463866|E1|Reported Event|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
392678|NCT00464087|B4|Baseline|Total|Total of all reporting groups
392679|NCT00464087|B3|Baseline|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
392680|NCT00464087|B2|Baseline|Bivalirudin|bivalirudin during angioplasty
392681|NCT00464087|B1|Baseline|Heparin|unfrationated heparin during angioplasty
392682|NCT00464087|P3|Participant Flow|Screen Failures|These patients were enrolled because they received study drug, but did not have enough disease to require PCI.
392683|NCT00464087|P2|Participant Flow|Bivalirudin|All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to Bivalirudin during angioplasty and receive a minimum dose of bolus 0.75 mg/kg IV followed by, infusion of 1.75 mg/kg/hr for the duration of the PCI.
392869|NCT00464308|E3|Reported Event|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392695|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
392696|NCT00464087|E3|Reported Event|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
392697|NCT00464087|E2|Reported Event|Bivalirudin|bivalirudin during angioplasty
392698|NCT00464087|E1|Reported Event|Heparin|unfrationated heparin during angioplasty
392699|NCT00464204|B3|Baseline|Total|Total of all reporting groups
392700|NCT00464204|B2|Baseline|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392701|NCT00464204|B1|Baseline|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392702|NCT00464204|P2|Participant Flow|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392703|NCT00464204|P1|Participant Flow|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392704|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392705|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392706|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392707|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392708|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392709|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392710|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 % NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392711|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4 Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day.
392712|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392713|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392714|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392715|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392716|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392717|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392718|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392719|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392720|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392721|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392722|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392723|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392724|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392725|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392726|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392727|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392728|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392729|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392730|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392731|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392732|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392733|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392884|NCT00464334|P11|Participant Flow|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
392734|NCT00464204|E2|Reported Event|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
392735|NCT00464204|E1|Reported Event|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
392736|NCT00464269|B5|Baseline|Total Title|
392737|NCT00464269|B4|Baseline|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
392738|NCT00464269|B3|Baseline|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
392739|NCT00464269|B2|Baseline|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
392740|NCT00464269|B1|Baseline|Placebo|Matching Placebo tablets administered twice a day
392741|NCT00464269|P4|Participant Flow|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
392742|NCT00464269|P3|Participant Flow|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
392743|NCT00464269|P2|Participant Flow|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
392744|NCT00464269|P1|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
392745|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392746|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392747|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392748|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392749|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392750|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392751|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392752|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392753|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392754|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392755|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392756|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392885|NCT00464334|P10|Participant Flow|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
392886|NCT00464334|P9|Participant Flow|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
392757|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392758|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392759|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392760|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392761|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392762|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392763|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392764|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392765|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392766|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392767|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392768|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392769|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392770|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392771|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392870|NCT00464308|E2|Reported Event|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392772|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392773|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392774|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392775|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392776|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392777|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392778|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392779|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392780|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392781|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392782|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392783|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392784|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392785|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392786|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392871|NCT00464308|E1|Reported Event|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392787|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392788|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392789|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392790|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392791|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392792|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392793|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392794|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392795|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392796|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392797|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392798|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392799|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392800|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392801|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392872|NCT00464334|B12|Baseline|Total|Total of all reporting groups
392873|NCT00464334|B11|Baseline|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
392802|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392803|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392804|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392805|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392806|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392807|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392808|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392809|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392810|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392811|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392812|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392813|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392814|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392815|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392816|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392874|NCT00464334|B10|Baseline|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
392875|NCT00464334|B9|Baseline|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
392817|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392818|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392819|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392820|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392821|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392822|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392823|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392824|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392825|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392826|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392827|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392828|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392829|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392830|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392831|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392876|NCT00464334|B8|Baseline|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
421252|NCT00540124|O1|Outcome|Placebo|by mouth once a day
392832|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392833|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392834|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392835|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392836|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
392837|NCT00464269|E4|Reported Event|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
392838|NCT00464269|E3|Reported Event|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
392839|NCT00464269|E2|Reported Event|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
392840|NCT00464269|E1|Reported Event|Placebo|Matching Placebo tablets administered twice a day
392841|NCT00464308|B4|Baseline|Total|Total of all reporting groups
392842|NCT00464308|B3|Baseline|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392843|NCT00464308|B2|Baseline|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392844|NCT00464308|B1|Baseline|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392845|NCT00464308|P3|Participant Flow|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392846|NCT00464308|P2|Participant Flow|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392847|NCT00464308|P1|Participant Flow|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392848|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392849|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392850|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392851|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392852|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392853|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392854|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392855|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392856|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392857|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392858|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392859|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392860|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392861|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392862|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392863|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392864|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392865|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392866|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392867|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
392887|NCT00464334|P8|Participant Flow|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
392888|NCT00464334|P7|Participant Flow|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
392889|NCT00464334|P6|Participant Flow|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
392890|NCT00464334|P5|Participant Flow|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
392891|NCT00464334|P4|Participant Flow|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
392892|NCT00464334|P3|Participant Flow|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
392893|NCT00464334|P2|Participant Flow|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
392894|NCT00464334|P1|Participant Flow|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg
392895|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
392896|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
392897|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
392898|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
392899|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
392900|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
392901|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
392902|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
392903|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
392904|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
392905|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
392906|NCT00464334|O11|Outcome|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
392907|NCT00464334|O10|Outcome|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
392908|NCT00464334|O9|Outcome|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
392909|NCT00464334|O8|Outcome|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
392910|NCT00464334|O7|Outcome|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
392911|NCT00464334|O6|Outcome|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
392912|NCT00464334|O5|Outcome|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
392913|NCT00464334|O4|Outcome|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
392914|NCT00464334|O3|Outcome|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
392915|NCT00464334|O2|Outcome|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
392916|NCT00464334|O1|Outcome|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
392917|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
392918|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
392919|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
392920|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
392921|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
392922|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
392923|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
392924|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
392925|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
392926|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
392927|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
392928|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
392929|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
392930|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
392931|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
392932|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
392933|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
392934|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
392935|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
392936|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
392937|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
392938|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
392939|NCT00464334|E11|Reported Event|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
392940|NCT00464334|E10|Reported Event|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
392941|NCT00464334|E9|Reported Event|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
392942|NCT00464334|E8|Reported Event|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
392943|NCT00464334|E7|Reported Event|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
392944|NCT00464334|E6|Reported Event|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
392945|NCT00464334|E5|Reported Event|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
421253|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
392946|NCT00464334|E4|Reported Event|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
392947|NCT00464334|E3|Reported Event|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
447395|NCT00596271|O2|Outcome|IC51 and HAVRIX|
392948|NCT00464334|E2|Reported Event|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
392949|NCT00464334|E1|Reported Event|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
392950|NCT00457951|B4|Baseline|Total|Total of all reporting groups
392951|NCT00457951|B3|Baseline|ODSH Treatment Group|ODSH Treatment Group Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
392952|NCT00457951|B2|Baseline|Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride|Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
392953|NCT00457951|B1|Baseline|Open-Label|Open-Label ODSH
392954|NCT00457951|P3|Participant Flow|ODSH Treatment Group|Double-blind randomized phase: The subjects receiving ODSH in the randomized portion of the study received 0.375 mg/kg/hr continuous IV infusion of ODSH for 96 hours.
392955|NCT00457951|P2|Participant Flow|Placebo Comparator: 0.9% Sodium Chloride|Double-blind randomized phase: Normal Saline infusion: Bolus infusion followed by a 4 day continuous infusion of placebo.
392956|NCT00457951|P1|Participant Flow|Open Label|"Open Label
The original protocol called for 304 subjects with exacerbation of COPD to be enrolled into the study. Thirteen patients with exacerbation of COPD were enrolled in the initial open label portion of the study. Of these thirteen subjects, the initial seven subjects were treated with an IV bolus of ODSH at 8 mg/kg followed by a continuous infusion of ODSH at 0.5 mg/kg/hr for 72 hours.
After an ad hoc safety committee assessed the safety of the data from the first seven subjects, six more subjects were treated concomitantly treated with ODSH and enoxaparin, a low molecular weight heparin commonly used for seriously ill hospitalized patients as DVT prophylaxis."
392957|NCT00457951|O2|Outcome|Randomized, Blinded, ODSH Arm|"Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.
ODSH: Randomized, Blinded, ODSH Arm"
392958|NCT00457951|O1|Outcome|0.9% Sodium Chloride|"Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.
Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride"
392959|NCT00457951|E3|Reported Event|ODSH Treatment Group|"Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.
ODSH: Randomized, Blinded, ODSH Arm"
392960|NCT00457951|E2|Reported Event|Placebo Comparator: 0.9% Sodium Chloride|"Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.
Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride"
392961|NCT00457951|E1|Reported Event|Open Label|"Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review.
Open-Label: ODSH administered open-label"
392962|NCT00457977|B3|Baseline|Total|Total of all reporting groups
392963|NCT00457977|B2|Baseline|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
392964|NCT00457977|B1|Baseline|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
392965|NCT00457977|P2|Participant Flow|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
392966|NCT00457977|P1|Participant Flow|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
392967|NCT00457977|O2|Outcome|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
392968|NCT00457977|O1|Outcome|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
392969|NCT00457977|O2|Outcome|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
392970|NCT00457977|O1|Outcome|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
392971|NCT00457977|E2|Reported Event|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
392972|NCT00457977|E1|Reported Event|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
392973|NCT00458211|B1|Baseline|Experimental|Open label change to ziprasidone
392974|NCT00458211|P1|Participant Flow|Experimental|Open label change to ziprasidone up to 120mg twice a day with meals
392975|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
392976|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
392977|NCT00458211|O1|Outcome|Experimental|All subjects, 17 at Buffalo and 19 at Bronx were given Ziprasidone.
392978|NCT00458211|O1|Outcome|Experimental|
392979|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
392980|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
392981|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
392982|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
392983|NCT00458211|E1|Reported Event|Experimental|Open label change to ziprasidone
392984|NCT00458237|B4|Baseline|Total|Total of all reporting groups
392985|NCT00458237|B3|Baseline|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392986|NCT00458237|B2|Baseline|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
393031|NCT00458302|E1|Reported Event|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393032|NCT00458406|B3|Baseline|Total|Total of all reporting groups
393033|NCT00458406|B2|Baseline|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
393034|NCT00458406|B1|Baseline|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
392987|NCT00458237|B1|Baseline|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392988|NCT00458237|P3|Participant Flow|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392989|NCT00458237|P2|Participant Flow|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392990|NCT00458237|P1|Participant Flow|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392991|NCT00458237|O2|Outcome|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392992|NCT00458237|O1|Outcome|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392993|NCT00458237|O2|Outcome|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392994|NCT00458237|O1|Outcome|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392995|NCT00458237|E3|Reported Event|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392996|NCT00458237|E2|Reported Event|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392997|NCT00458237|E1|Reported Event|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
392998|NCT00458302|B3|Baseline|Total|Total of all reporting groups
392999|NCT00458302|B2|Baseline|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393000|NCT00458302|B1|Baseline|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393001|NCT00458302|P2|Participant Flow|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393002|NCT00458302|P1|Participant Flow|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393003|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393004|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393005|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393006|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393007|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393008|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393009|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393010|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393011|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393012|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393013|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393014|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393015|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393016|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393017|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393018|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393019|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393020|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393021|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393022|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393023|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393024|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393025|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393026|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393027|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393028|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
393029|NCT00458302|E3|Reported Event|Total|
393030|NCT00458302|E2|Reported Event|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
393035|NCT00458406|P2|Participant Flow|CPAP|"Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.
Of the N=56 assessed subjects, N=13 were enrolled into the CPAP arm."
393036|NCT00458406|P1|Participant Flow|Bi-Flex|"Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study. Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy. In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.
Of the N=56 assessed subjects, N=43 were enrolled into the Bi-Flex arm."
393037|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
393038|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
393039|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
393040|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
393041|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
393042|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
393043|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
393044|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
393045|NCT00458406|O2|Outcome|CPAP|Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
393046|NCT00458406|O1|Outcome|BiFlex|Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
393047|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
393048|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
393049|NCT00458406|O2|Outcome|CPAP|Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
393050|NCT00458406|O1|Outcome|Bi-Flex|Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
393051|NCT00458406|E2|Reported Event|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
393052|NCT00458406|E1|Reported Event|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
393053|NCT00458536|B1|Baseline|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
393054|NCT00458536|P1|Participant Flow|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
393055|NCT00458536|O1|Outcome|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
393056|NCT00458536|E1|Reported Event|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
393057|NCT00464438|B3|Baseline|Total|Total of all reporting groups
393058|NCT00464438|B2|Baseline|Moxifloxacin 0.5%|
393059|NCT00464438|B1|Baseline|Gatifloxacin 0.3%|
393060|NCT00464438|P2|Participant Flow|Moxifloxacin 0.5%|
393061|NCT00464438|P1|Participant Flow|Gatifloxacin 0.3%|
393062|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
393063|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
393064|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
393065|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
393066|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
393067|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
393068|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
393069|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
393070|NCT00464438|E2|Reported Event|Moxifloxacin 0.5%|
393071|NCT00464438|E1|Reported Event|Gatifloxacin 0.3%|
393072|NCT00464464|B3|Baseline|Total|Total of all reporting groups
393073|NCT00464464|B2|Baseline|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
393074|NCT00464464|B1|Baseline|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.
These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
393075|NCT00464464|P2|Participant Flow|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
393076|NCT00464464|P1|Participant Flow|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.
These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
393097|NCT00464542|P1|Participant Flow|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
393077|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
393078|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.
These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
393079|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
393080|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.
These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
393081|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
393082|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.
These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
393083|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
393084|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.
These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
393085|NCT00464464|E2|Reported Event|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
393086|NCT00464464|E1|Reported Event|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.
These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
393087|NCT00464490|B3|Baseline|Total|Total of all reporting groups
393088|NCT00464490|B2|Baseline|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
393089|NCT00464490|B1|Baseline|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation
Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
393090|NCT00464490|P2|Participant Flow|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
393091|NCT00464490|P1|Participant Flow|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation
Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
393092|NCT00464490|O2|Outcome|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
393093|NCT00464490|O1|Outcome|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation
Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
393094|NCT00464490|E2|Reported Event|Standard Hospital Protocol (CG)|Control. Hospital weaning per standard protocol
393095|NCT00464490|E1|Reported Event|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation
Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
393096|NCT00464542|B1|Baseline|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
393098|NCT00464542|O1|Outcome|Post-treatment MASH Cohort|Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
393099|NCT00464542|O1|Outcome|Post-treatment MASH Cohort|Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
393100|NCT00464542|E1|Reported Event|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
393101|NCT00464568|B1|Baseline|Overall Study|Eligible participants received unit dose of nasal GSK256066 1 mcg or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
393102|NCT00464568|P1|Participant Flow|Overall Study|Eligible participants received unit dose of nasal GSK256066 1 microgram (mcg) or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
393103|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393104|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393105|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393106|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393107|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
393108|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393109|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393110|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393111|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393112|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
393113|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393114|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393115|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393116|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393117|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393118|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393119|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393120|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393121|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393122|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393123|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393124|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393321|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393125|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393126|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393127|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393128|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393129|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393130|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393131|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393132|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393133|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393134|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393135|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393136|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393137|NCT00464568|O1|Outcome|Overall Study|Eligible participants received unit dose of nasal GSK256066 1 mcg or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
393138|NCT00464568|O1|Outcome|Overall Study|Eligible participants received unit dose of nasal GSK256066 1 mcg or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
393139|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393140|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393141|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393142|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393143|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
393144|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393145|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393146|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393147|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393148|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
393149|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393150|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393151|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393152|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393153|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
421254|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
393154|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393155|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393156|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393157|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393158|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
393159|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393160|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393161|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393162|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393163|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
393164|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
393165|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
393166|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
393167|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
393168|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
393169|NCT00464568|E5|Reported Event|GSK256066 200 mcg|Participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
393170|NCT00464568|E4|Reported Event|GSK256066 50 mcg|Participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
393171|NCT00464568|E3|Reported Event|GSK256066 10 mcg|Participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
393172|NCT00464568|E2|Reported Event|GSK256066 1 mcg|Participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
393173|NCT00464568|E1|Reported Event|Placebo|Participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
393174|NCT00464646|B3|Baseline|Total|Total of all reporting groups
393175|NCT00464646|B2|Baseline|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
393176|NCT00464646|B1|Baseline|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
393177|NCT00464646|P2|Participant Flow|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
393178|NCT00464646|P1|Participant Flow|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
393179|NCT00464646|O2|Outcome|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
393180|NCT00464646|O1|Outcome|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
393181|NCT00464646|E2|Reported Event|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
393182|NCT00464646|E1|Reported Event|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
393183|NCT00464672|B3|Baseline|Total|Total of all reporting groups
393184|NCT00464672|B2|Baseline|Comparator Influenza Vaccine|Injections of the comparator influenza vaccine were administered intramuscularly
393185|NCT00464672|B1|Baseline|Influenza Virus Vaccine|Injections of the investigational influenza virus vaccine were administered intramuscularly
393322|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393186|NCT00464672|P6|Participant Flow|Comparator Influenza Vaccine (3 to 8 Years)|Two injections of the comparator influenza vaccine were administered intramuscularly
447396|NCT00596271|O1|Outcome|IC51 and Placebo|
393187|NCT00464672|P5|Participant Flow|Influenza Virus Vaccine (3 to 8 Years)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
393188|NCT00464672|P4|Participant Flow|Comparator Influenza Vaccine (9 to 17 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
393189|NCT00464672|P3|Participant Flow|Influenza Virus Vaccine (9 to 17 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393190|NCT00464672|P2|Participant Flow|Comparator Influenza Vaccine (18 to 64 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
393191|NCT00464672|P1|Participant Flow|Influenza Virus Vaccine (18 to 64 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393192|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
393193|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
393194|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
393195|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393196|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393197|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393198|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (Injection 2)|Injections of the comparator influenza vaccine were administered intramuscularly.
393199|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Injection 2)|Injections of the investigational influenza virus vaccine were administered intramuscularly.
393200|NCT00464672|O2|Outcome|Comparator Influenza Vaccine (Injection 1)|Injections of the comparator influenza vaccine were administered intramuscularly.
393201|NCT00464672|O1|Outcome|Influenza Virus Vaccine (Injection 1)|Injections of the investigational influenza virus vaccine were administered intramuscularly.
393202|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
393203|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
393204|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
393205|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
393206|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
393207|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
393208|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
393209|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
393210|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
393211|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
393212|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
393213|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
393214|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
393215|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
393216|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
393217|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
393218|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
393219|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
393220|NCT00464672|O2|Outcome|Comparator Influenza Vaccine|Injection of the comparator influenza vaccine were administered intramuscularly
393221|NCT00464672|O1|Outcome|Influenza Virus Vaccine|Injection of the investigational influenza virus vaccine were administered intramuscularly
393222|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
393223|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
393224|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
393225|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393226|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393227|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393228|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
393229|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
393230|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
393231|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393232|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393233|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393234|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
393235|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
393236|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
393237|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393238|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393239|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393240|NCT00464672|O2|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza vaccine was administered intramuscularly
393241|NCT00464672|O1|Outcome|Influenza Virus Vaccine|One injection of the investigational influenza virus vaccine was administered intramuscularly
393242|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
393243|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
393244|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
393245|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393246|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393247|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393248|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
393249|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
393250|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
393251|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393252|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393253|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393254|NCT00464672|E6|Reported Event|Comparator Influenza Vaccine (3 to 8 Years)|Two injections of the comparator influenza vaccine were administered intramuscularly
393255|NCT00464672|E5|Reported Event|Influenza Virus Vaccine (3 to 8 Years)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
393256|NCT00464672|E4|Reported Event|Comparator Influenza Vaccine (9 to 17 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
393257|NCT00464672|E3|Reported Event|Influenza Virus Vaccine (9 to 17 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393258|NCT00464672|E2|Reported Event|Comparator Influenza Vaccine (18 to 64 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
393259|NCT00464672|E1|Reported Event|Influenza Virus Vaccine (18 to 64 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
393260|NCT00464685|B3|Baseline|Total|Total of all reporting groups
393261|NCT00464685|B2|Baseline|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393262|NCT00464685|B1|Baseline|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393263|NCT00464685|P2|Participant Flow|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393264|NCT00464685|P1|Participant Flow|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393265|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393266|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393267|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393323|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393324|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393325|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
448187|NCT00605475|B11|Baseline|Total|Total of all reporting groups
393268|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393269|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393270|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393271|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393272|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393273|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393274|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393275|NCT00464685|E2|Reported Event|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393276|NCT00464685|E1|Reported Event|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
393277|NCT00464698|B1|Baseline|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
393278|NCT00464698|P1|Participant Flow|All Study Participants|Duloxetine Week 1 dose: 30mg Duloxetine Weeks 2-4 dose: 60mg Duloxetine Weeks 5-17 dose: 120mg
393279|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
393280|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
393281|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
393282|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
393283|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
393284|NCT00464698|E3|Reported Event|Duloxetine Weeks 5-17 Dose: 120mg|
393285|NCT00464698|E2|Reported Event|Duloxetine Weeks 2-4 Dose: 60mg|
393286|NCT00464698|E1|Reported Event|Duloxetine: Week 1 Dose: 30mg|
393287|NCT00468845|B4|Baseline|Total|Total of all reporting groups
393288|NCT00468845|B3|Baseline|Placebo|Matching placebo capsule
393289|NCT00468845|B2|Baseline|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393290|NCT00468845|B1|Baseline|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393291|NCT00468845|P3|Participant Flow|Placebo|Matching placebo capsule
393292|NCT00468845|P2|Participant Flow|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393293|NCT00468845|P1|Participant Flow|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393294|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393295|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393296|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393297|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393298|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393299|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393300|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393301|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393302|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393303|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393304|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393305|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393306|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393307|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393308|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393309|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393310|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393311|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393312|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393313|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393314|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393315|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393316|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393317|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393318|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393319|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393320|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393326|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393327|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393328|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393329|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393330|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393331|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393332|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393333|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393334|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393335|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393336|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393337|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393338|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393339|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393340|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393341|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393342|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393343|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393344|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393345|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393346|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393347|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393348|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393349|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393350|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393351|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393352|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393353|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393354|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393355|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393356|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393357|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393358|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393359|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393360|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393361|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393362|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393363|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393364|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393365|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393366|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393367|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393368|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393369|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393370|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393371|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393372|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393373|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393374|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393375|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393376|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393377|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393378|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393379|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393380|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393381|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393382|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393383|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393384|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393385|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393386|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393387|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393388|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393389|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393390|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393391|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393392|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393393|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393394|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393395|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393396|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393397|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393398|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393399|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393400|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393401|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393402|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393403|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393404|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393405|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393406|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393407|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393408|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393409|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393410|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393411|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393412|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393413|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393414|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393415|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393416|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393417|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393418|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393419|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393420|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
393421|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393422|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393423|NCT00468845|E3|Reported Event|Placebo|Matching placebo capsule
393424|NCT00468845|E2|Reported Event|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
393425|NCT00468845|E1|Reported Event|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
393426|NCT00468858|B4|Baseline|Total|Total of all reporting groups
393427|NCT00468858|B3|Baseline|Placebo|"Control
Placebo: Lyophilized, single dose vials and sterile water for
> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
393428|NCT00468858|B2|Baseline|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose
T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393429|NCT00468858|B1|Baseline|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose
T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393430|NCT00468858|P3|Participant Flow|Placebo|"Control
Placebo: Lyophilized, single dose vials and sterile water for
> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
393431|NCT00468858|P2|Participant Flow|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose
T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393432|NCT00468858|P1|Participant Flow|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose
T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393433|NCT00468858|O36|Outcome|DEN-4, Placebo, Total|Antibody DEN-4, Placebo group, Pre-vaccination status = Total
393434|NCT00468858|O35|Outcome|DEN-4, Placebo, S+|Antibody DEN-4, Placebo group, Pre-vaccination status = S+
393435|NCT00468858|O34|Outcome|DEN-4, Placebo, S-|Antibody DEN-4, Placebo group, Pre-vaccination status = S-
393436|NCT00468858|O33|Outcome|DEN-4, F19, Total|Antibody DEN-4, Group F19, Pre-vaccination status = Total
393437|NCT00468858|O32|Outcome|DEN-4, F19, S+|Antibody DEN-4, Group F19, Pre-vaccination status = S+
393438|NCT00468858|O31|Outcome|DEN-4, F19, S-|Antibody DEN-4, Group F19, Pre-vaccination status = S-
393439|NCT00468858|O30|Outcome|DEN-4, F17, Total|Antibody DEN-4, Group F17, Pre-vaccination status = Total
393440|NCT00468858|O29|Outcome|DEN-4, F17, S+|Antibody DEN-4, Group F17, Pre-vaccination status = S+
393441|NCT00468858|O28|Outcome|DEN-4, F17, S-|Antibody DEN-4, Group F17, Pre-vaccination status = S-
393442|NCT00468858|O27|Outcome|DEN-3, Placebo, Total|Antibody DEN-3, Placebo group, Pre-vaccination status = Total
393443|NCT00468858|O26|Outcome|DEN-3, Placebo, S+|Antibody DEN-3, Placebo group, Pre-vaccination status = S+
393444|NCT00468858|O25|Outcome|DEN-3, Placebo, S-|Antibody DEN-3, Placebo group, Pre-vaccination status = S-
393445|NCT00468858|O24|Outcome|DEN-3, F19, Total|Antibody DEN-3, Group F19, Pre-vaccination status = Total
393446|NCT00468858|O23|Outcome|DEN-3, F19, S+|Antibody DEN-3, Group F19, Pre-vaccination status = S+
393447|NCT00468858|O22|Outcome|DEN-3, F19, S-|Antibody DEN-3, Group F19, Pre-vaccination status = S-
393448|NCT00468858|O21|Outcome|DEN-3, F17, Total|Antibody DEN-3, Group F17, Pre-vaccination status = Total
393449|NCT00468858|O20|Outcome|DEN-3, F17, S+|Antibody DEN-3, Group F17, Pre-vaccination status = S+
393450|NCT00468858|O19|Outcome|DEN-3, F17, S-|Antibody DEN-3, Group F17, Pre-vaccination status = S-
393451|NCT00468858|O18|Outcome|DEN-2, Placebo, Total|Antibody DEN-2, Placebo group, Pre-vaccination status = Total
393452|NCT00468858|O17|Outcome|DEN-2, Placebo, S+|Antibody DEN-2, Placebo group, Pre-vaccination status = S+
393453|NCT00468858|O16|Outcome|DEN-2, Placebo, S-|Antibody DEN-2, Placebo group, Pre-vaccination status = S-
393454|NCT00468858|O15|Outcome|DEN-2, F19, Total|Antibody DEN-2, Group F19, Pre-vaccination status = Total
393455|NCT00468858|O14|Outcome|DEN-2, F19, S+|Antibody DEN-2, Group F19, Pre-vaccination status = S+
393456|NCT00468858|O13|Outcome|DEN-2, F19, S-|Antibody DEN-2, Group F19, Pre-vaccination status = S-
393457|NCT00468858|O12|Outcome|DEN-2, F17, Total|Antibody DEN-2,. Group F17, Pre-vaccination status = Total
393458|NCT00468858|O11|Outcome|DEN-2, F17, S+|Antibody DEN-2, Group F17, Pre-vaccination status = S+
393459|NCT00468858|O10|Outcome|DEN-2, F17, S-|Antibody DEN-2, Group F17, Pre-vaccination status = S-
393460|NCT00468858|O9|Outcome|DEN-1, Placebo, Total|Antibody DEN-1, Placebo group, Pre-vaccination status = Total
393461|NCT00468858|O8|Outcome|DEN-1, Placebo, S+|Antibody DEN-1, Placebo group, Pre-vaccination status = S+
393462|NCT00468858|O7|Outcome|DEN-1, Placebo, S-|Antibody DEN-1, Placebo group, Pre-vaccination status = S-
393463|NCT00468858|O6|Outcome|DEN-1, F19, Total|Antibody DEN-1, Group F19, Pre-vaccination status = Total
393464|NCT00468858|O5|Outcome|DEN-1, F19, S+|Antibody DEN-1, Group F19, Pre-vaccination group = S+
393465|NCT00468858|O4|Outcome|DEN-1, F19, S-|Antibody DEN-1, Group F19, Pre-vaccination status = S-
393466|NCT00468858|O3|Outcome|DEN-1, F17, Total|Antibody DEN-1, Group F17, Pre-vaccination status = Total
393467|NCT00468858|O2|Outcome|DEN-1, F17, S+|Antibody DEN-1, Group F17, Pre-vaccination status = S+
393468|NCT00468858|O1|Outcome|DEN-1, F17, S-|Antibody DEN-1, Group F17, Pre-vaccination status = S-
393469|NCT00468858|O36|Outcome|DEN-4, Placebo, Total|Antibody DEN-4, Placebo group, Pre-vaccination status = Total
393470|NCT00468858|O35|Outcome|DEN-4, Placebo, S+|Antibody DEN-4, Placebo group, Pre-vaccination status = S+
393471|NCT00468858|O34|Outcome|DEN-4, Placebo, S-|Antibody DEN-4, Placebo group, Pre-vaccination status = S-
393472|NCT00468858|O33|Outcome|DEN-4, F19, Total|Antibody DEN-4, Group F19, Pre-vaccination status = Total
393473|NCT00468858|O32|Outcome|DEN-4, F19, S+|Antibody DEN-4, Group F19, Pre-vaccination status = S+
393474|NCT00468858|O31|Outcome|DEN-4, F19, S-|Antibody DEN-4, Group F19, Pre-vaccination status = S-
393475|NCT00468858|O30|Outcome|DEN-4, F17, Total|Antibody DEN-4, Group F17, Pre-vaccination status = Total
393476|NCT00468858|O29|Outcome|DEN-4, F17, S+|Antibody DEN-4, Group F17, Pre-vaccination status = S+
393477|NCT00468858|O28|Outcome|DEN-4, F17, S-|Antibody DEN-4, Group F17, Pre-vaccination status = S-
393478|NCT00468858|O27|Outcome|DEN-3, Placebo, Total|Antibody DEN-3, Placebo group, Pre-vaccination status = Total
393479|NCT00468858|O26|Outcome|DEN-3, Placebo, S+|Antibody DEN-3, Placebo group, Pre-vaccination status = S+
393480|NCT00468858|O25|Outcome|DEN-3, Placebo, S-|Antibody DEN-3, Placebo group, Pre-vaccination status = S-
393481|NCT00468858|O24|Outcome|DEN-3, F19, Total|Antibody DEN-3, Group F19, Pre-vaccination status = Total
393482|NCT00468858|O23|Outcome|DEN-3, F19, S+|Antibody DEN-3, Group F19, Pre-vaccination status = S+
393483|NCT00468858|O22|Outcome|DEN-3, F19, S-|Antibody DEN-3, Group F19, Pre-vaccination status = S-
393484|NCT00468858|O21|Outcome|DEN-3, F17, Total|Antibody DEN-3, Group F17, Pre-vaccination status = Total
393485|NCT00468858|O20|Outcome|DEN-3, F17, S+|Antibody DEN-3, Group F17, Pre-vaccination status = S+
393486|NCT00468858|O19|Outcome|DEN-3, F17, S-|Antibody DEN-3, Group F17, Pre-vaccination status = S-
393487|NCT00468858|O18|Outcome|DEN-2, Placebo, Total|Antibody DEN-2, Placebo group, Pre-vaccination status = Total
393488|NCT00468858|O17|Outcome|DEN-2, Placebo, S+|Antibody DEN-2, Placebo group, Pre-vaccination status = S+
393489|NCT00468858|O16|Outcome|DEN-2, Placebo, S-|Antibody DEN-2, Placebo group, Pre-vaccination status = S-
393490|NCT00468858|O15|Outcome|DEN-2, F19, Total|Antibody DEN-2, Group F19, Pre-vaccination status = Total
393491|NCT00468858|O14|Outcome|DEN-2, F19, S+|Antibody DEN-2, Group F19, Pre-vaccination status = S+
393492|NCT00468858|O13|Outcome|DEN-2, F19, S-|Antibody DEN-2, Group F19, Pre-vaccination status = S-
393493|NCT00468858|O12|Outcome|DEN-2, F17, Total|Antibody DEN-2,. Group F17, Pre-vaccination status = Total
393494|NCT00468858|O11|Outcome|DEN-2, F17, S+|Antibody DEN-2, Group F17, Pre-vaccination status = S+
393495|NCT00468858|O10|Outcome|DEN-2, F17, S-|Antibody DEN-2, Group F17, Pre-vaccination status = S-
393496|NCT00468858|O9|Outcome|DEN-1, Placebo, Total|Antibody DEN-1, Placebo group, Pre-vaccination status = Total
393497|NCT00468858|O8|Outcome|DEN-1, Placebo, S+|Antibody DEN-1, Placebo group, Pre-vaccination status = S+
393498|NCT00468858|O7|Outcome|DEN-1, Placebo, S-|Antibody DEN-1, Placebo group, Pre-vaccination status = S-
393499|NCT00468858|O6|Outcome|DEN-1, F19, Total|Antibody DEN-1, Group F19, Pre-vaccination status = Total
393500|NCT00468858|O5|Outcome|DEN-1, F19, S+|Antibody DEN-1, Group F19, Pre-vaccination group = S+
393501|NCT00468858|O4|Outcome|DEN-1, F19, S-|Antibody DEN-1, Group F19, Pre-vaccination status = S-
393502|NCT00468858|O3|Outcome|DEN-1, F17, Total|Antibody DEN-1, Group F17, Pre-vaccination status = Total
393503|NCT00468858|O2|Outcome|DEN-1, F17, S+|Antibody DEN-1, Group F17, Pre-vaccination status = S+
393504|NCT00468858|O1|Outcome|DEN-1, F17, S-|Antibody DEN-1, Group F17, Pre-vaccination status = S-
393505|NCT00468858|O12|Outcome|Placebo: PII (M7)|Placebo control Post-dose 2, month 7
393506|NCT00468858|O11|Outcome|Placebo: PI (M6)|Placebo control Post-dose 1, month 6
393507|NCT00468858|O10|Outcome|Placebo: PI (M3)|Placebo control Post-dose 1, month 3
393508|NCT00468858|O9|Outcome|Placebo: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
393509|NCT00468858|O8|Outcome|F19 PII (M7)|Post-Transfection F-19 Post-dose 2, month 7
393510|NCT00468858|O7|Outcome|F19 PI (M6)|Post-Transfection F-19 Post-dose 1, month 6
393511|NCT00468858|O6|Outcome|F19 PI (M3)|Post-Transfection F-19 Post-dose 1, month 3
393512|NCT00468858|O5|Outcome|F19: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
393513|NCT00468858|O4|Outcome|F17 PII (M7)|Post-Transfection F-17 Post-dose 2, month 7
393514|NCT00468858|O3|Outcome|F17 PI (M6)|Post-Transfection F-17 Post-dose 1, month 6
393515|NCT00468858|O2|Outcome|F17 PI (M3)|Post-Transfection F-17 Post-dose 1, month 3
393516|NCT00468858|O1|Outcome|F17: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
393517|NCT00468858|O12|Outcome|Placebo: PII (M7)|Placebo control Post-dose 2, month 7
393518|NCT00468858|O11|Outcome|Placebo: PI (M6)|Placebo control Post-dose 1, month 6
393519|NCT00468858|O10|Outcome|Placebo: PI (M3)|Placebo control Post-dose 1, month 3
393520|NCT00468858|O9|Outcome|Placebo: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
393521|NCT00468858|O8|Outcome|F19 PII (M7)|Post-Transfection F-19 Post-dose 2, month 7
393522|NCT00468858|O7|Outcome|F19 PI (M6)|Post-Transfection F-19 Post-dose 1, month 6
393523|NCT00468858|O6|Outcome|F19 PI (M3)|Post-Transfection F-19 Post-dose 1, month 3
393524|NCT00468858|O5|Outcome|F19: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
393525|NCT00468858|O4|Outcome|F17 PII (M7)|Post-Transfection F-17 Post-dose 2, month 7
393526|NCT00468858|O3|Outcome|F17 PI (M6)|Post-Transfection F-17 Post-dose 1, month 6
393527|NCT00468858|O2|Outcome|F17 PI (M3)|Post-Transfection F-17 Post-dose 1, month 3
393528|NCT00468858|O1|Outcome|F17: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
393529|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose
T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393530|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose
T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393531|NCT00468858|O6|Outcome|After 31-Day Post-Vaccination Period: Placebo|"Control
Placebo: Lyophilized, single dose vials and sterile water for
> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
393532|NCT00468858|O5|Outcome|After 31-Day Post Vaccination Period: F19|"Post-Transfection F19, full dose
T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393533|NCT00468858|O4|Outcome|After 31-Day Post Vaccination Period: F17|"Post-Transfection F17, full dose
T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393534|NCT00468858|O3|Outcome|During 31-Day Post Vaccination: Placebo|"Control
Placebo: Lyophilized, single dose vials and sterile water for
> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
393535|NCT00468858|O2|Outcome|During 31-Day Post Vaccination: F19|"Post-Transfection F19, full dose
T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393536|NCT00468858|O1|Outcome|During 31-Day Post Vaccination: F17|"Post-Transfection F17, full dose
T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393537|NCT00468858|O3|Outcome|Placebo|"Control
Placebo: Lyophilized, single dose vials and sterile water for
> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
393538|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose
T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393539|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose
T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393540|NCT00468858|O3|Outcome|Placebo|"Control
Placebo: Lyophilized, single dose vials and sterile water for
> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
393541|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose
T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393542|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose
T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393543|NCT00468858|O3|Outcome|Placebo|"Control
Placebo: Lyophilized, single dose vials and sterile water for
> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
393544|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose
T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393545|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose
T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393546|NCT00468858|E3|Reported Event|Placebo|"Control
Placebo: Lyophilized, single dose vials and sterile water for
> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
393547|NCT00468858|E2|Reported Event|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose
T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393548|NCT00468858|E1|Reported Event|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose
T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
393549|NCT00468910|B3|Baseline|Total|Total of all reporting groups
393550|NCT00468910|B2|Baseline|Placebo|Patients receive oral placebo once daily.
393551|NCT00468910|B1|Baseline|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
393552|NCT00468910|P2|Participant Flow|Placebo|Patients receive oral placebo once daily.
393553|NCT00468910|P1|Participant Flow|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
393554|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
393555|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
393556|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
393557|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
393558|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
393559|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
393560|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
393561|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
393562|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
393563|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) 325 mg once daily.
393564|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
393565|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) 325 mg once daily.
393669|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled Type 2 diabetic subjects.
393566|NCT00468910|E2|Reported Event|Placebo|"Patients receive oral placebo once daily.
placebo: Given orally
laboratory biomarker analysis: Correlative study"
393567|NCT00468910|E1|Reported Event|Acetylsalicylic Acid|"Patients receive oral acetylsalicylic acid (aspirin) once daily.
acetylsalicylic acid: Given orally
laboratory biomarker analysis: Correlative study"
393568|NCT00469079|B4|Baseline|Total|Total of all reporting groups
393569|NCT00469079|B3|Baseline|Assigned to Camel Snus|Camel Snus - oral tobacco product
393570|NCT00469079|B2|Baseline|Assigned to Taboka|Taboka - oral tobacco product
393571|NCT00469079|B1|Baseline|Assigned to NRT|Nicotine gum or nicotine lozenge
393572|NCT00469079|P3|Participant Flow|Assigned to Camel Snus|Camel Snus - oral tobacco product
393573|NCT00469079|P2|Participant Flow|Assigned to Taboka|Taboka - oral tobacco product
393574|NCT00469079|P1|Participant Flow|Assigned to NRT|Nicotine gum or nicotine lozenge
393575|NCT00469079|O3|Outcome|Snus|A spitless, oral tobacco pouch.
393576|NCT00469079|O2|Outcome|Taboka|A spitless, oral tobacco pouch.
393577|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or lozenge
393578|NCT00469079|O3|Outcome|Camel Snus|Camel Snus - oral tobacco product
393579|NCT00469079|O2|Outcome|Taboka|Taboka - oral tobacco product
393580|NCT00469079|O1|Outcome|Medicinal Nicotine|Nicotine gum or nicotine lozenge
393581|NCT00469079|O3|Outcome|Snus|A spitless, oral tobacco pouch.
393582|NCT00469079|O2|Outcome|Taboka|A spitless, oral tobacco pouch.
393583|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or lozenge
393584|NCT00469079|O3|Outcome|Snus|Camel Snus, a spitless oral tobacco product currently marketed as a substitute for cigarettes. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
393585|NCT00469079|O2|Outcome|Taboka|Taboka, a spitless oral tobacco product that has been discontinued. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
393586|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or nicotine lozenge
393587|NCT00469079|E3|Reported Event|Assigned to Camel Snus|Camel Snus - oral tobacco product
393588|NCT00469079|E2|Reported Event|Assigned to Taboka|Taboka - oral tobacco product
393589|NCT00469079|E1|Reported Event|Assigned to NRT|Nicotine gum or nicotine lozenge
393590|NCT00469092|B3|Baseline|Total|Total of all reporting groups
393591|NCT00469092|B2|Baseline|Glargine|Insulin glargine + metformin + glimepiride
393592|NCT00469092|B1|Baseline|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
393593|NCT00469092|P2|Participant Flow|Glargine|Insulin glargine + metformin + glimepiride
393594|NCT00469092|P1|Participant Flow|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
393595|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
393596|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
393597|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
393598|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
393599|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
393600|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
393601|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
393602|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
393603|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
393604|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
393605|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
393606|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
393607|NCT00469092|E2|Reported Event|Glargine|Insulin glargine + metformin + glimepiride
393608|NCT00469092|E1|Reported Event|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
393609|NCT00469209|B4|Baseline|Total|Total of all reporting groups
393610|NCT00469209|B3|Baseline|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393611|NCT00469209|B2|Baseline|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393612|NCT00469209|B1|Baseline|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393613|NCT00469209|P3|Participant Flow|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393614|NCT00469209|P2|Participant Flow|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393615|NCT00469209|P1|Participant Flow|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393616|NCT00469209|O3|Outcome|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393617|NCT00469209|O2|Outcome|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393618|NCT00469209|O1|Outcome|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393619|NCT00469209|E3|Reported Event|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393620|NCT00469209|E2|Reported Event|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393621|NCT00469209|E1|Reported Event|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
393623|NCT00469274|B2|Baseline|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
393624|NCT00469274|B1|Baseline|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
393625|NCT00469274|P2|Participant Flow|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
393626|NCT00469274|P1|Participant Flow|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
393627|NCT00469274|O2|Outcome|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
393628|NCT00469274|O1|Outcome|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
393629|NCT00469274|E2|Reported Event|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
393630|NCT00469274|E1|Reported Event|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
393631|NCT00469391|B3|Baseline|Total|Total of all reporting groups
393632|NCT00469391|B2|Baseline|Sham Control|Sham Procedure: Weight loss
393633|NCT00469391|B1|Baseline|GI Sleeve|"medical device that mimics gastric bypass mechanism for weight-loss
GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss"
393634|NCT00469391|P2|Participant Flow|Sham Control|Sham Procedure followed by standard-of-care diet therapy
393635|NCT00469391|P1|Participant Flow|GI Sleeve|GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss followed by standard-of-care diet therapy
393636|NCT00469391|O2|Outcome|Sham Control|Sham Procedure: Weight loss
393637|NCT00469391|O1|Outcome|GI Sleeve|"medical device that mimics gastric bypass mechanism for weight-loss
GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss"
393638|NCT00469391|E2|Reported Event|Sham Control|3 subjects withdrew before the procedure. N=26 for the ITT population.
393639|NCT00469391|E1|Reported Event|GI Sleeve|N=26 for attempted device implant procedures. There were 2 subjects who withdrew from the study before the procedure and 4 unsuccessful procedure. Thus, N=21 for ITT population ( subjects with implanted devices).
393640|NCT00469456|B3|Baseline|Total|Total of all reporting groups
393641|NCT00469456|B2|Baseline|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
393642|NCT00469456|B1|Baseline|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
393643|NCT00469456|P2|Participant Flow|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
393644|NCT00469456|P1|Participant Flow|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
393645|NCT00469456|O2|Outcome|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
393646|NCT00469456|O1|Outcome|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
393647|NCT00469456|O2|Outcome|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
393648|NCT00469456|O1|Outcome|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
393649|NCT00469456|E2|Reported Event|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
393650|NCT00469456|E1|Reported Event|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
393651|NCT00469508|B3|Baseline|Total|Total of all reporting groups
393652|NCT00469508|B2|Baseline|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
393653|NCT00469508|B1|Baseline|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
393654|NCT00469508|P2|Participant Flow|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
393655|NCT00469508|P1|Participant Flow|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
393656|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
393657|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
393658|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
393659|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
393660|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
393661|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
393662|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
393663|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
393664|NCT00469508|E2|Reported Event|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
393665|NCT00469508|E1|Reported Event|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
393666|NCT00469833|B1|Baseline|Arm 1|"Within subjects comparison; before and after treatment.
Beta-cell function measured with OGTT/hyperglycemic clamp"
393667|NCT00469833|P1|Participant Flow|Uncontrolled Type 2 Diabetic Subjects|Eligible subjects will have measures of insulin secretion measured using the OGTT/hyperglycemic clamp technique before and after 2 months of treatment to lower blood glucose.
393668|NCT00469833|O1|Outcome|Uncontrolled Type 2 Diabetic Subjects|
393670|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled Type 2 diabetic subjects.
393671|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled type 2 diabetic subjects
393672|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled Type 2 diabetic subjects
393673|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled type 2 diabetic subjects.
393674|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled type 2 diabetic subjects.
393675|NCT00469833|E1|Reported Event|Arm 1|"Within subjects comparison; before and after treatment.
Beta-cell function measured with OGTT/hyperglycemic clamp"
393676|NCT00469859|B3|Baseline|Total|Total of all reporting groups
393677|NCT00469859|B2|Baseline|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)"
393678|NCT00469859|B1|Baseline|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)"
393679|NCT00469859|P2|Participant Flow|Group 2 (Lestaurtinib: Dose 62.5 mg/m2)|"COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
cytarabine"
393680|NCT00469859|P1|Participant Flow|Group 1 (Lestaurtinib Dose 50 mg/m2)|"COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)"
393681|NCT00469859|O2|Outcome|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)"
393682|NCT00469859|O1|Outcome|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)"
393713|NCT00470106|P2|Participant Flow|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
393714|NCT00470106|P1|Participant Flow|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
393715|NCT00470106|O4|Outcome|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
393716|NCT00470106|O3|Outcome|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
393683|NCT00469859|O2|Outcome|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)"
393684|NCT00469859|O1|Outcome|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)"
393685|NCT00469859|E2|Reported Event|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)"
393686|NCT00469859|E1|Reported Event|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)"
393687|NCT00469898|B1|Baseline|Therapeutic Intervention|
393688|NCT00469898|P1|Participant Flow|Therapeutic Intervention|
393689|NCT00469898|O1|Outcome|Therapeutic Intervention|
393690|NCT00469898|O1|Outcome|Therapeutic Intervention|
393691|NCT00469898|O1|Outcome|Therapeutic Intervention|
393692|NCT00469898|O1|Outcome|Therapeutic Intervention|
393693|NCT00469898|E1|Reported Event|Therapeutic Intervention|
393694|NCT00470054|B1|Baseline|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
393695|NCT00470054|P1|Participant Flow|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
393696|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
393697|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
393698|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
393699|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
393700|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
393701|NCT00470054|E1|Reported Event|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
393702|NCT00470067|B1|Baseline|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
carboplatin: IV
pegylated liposomal doxorubicin hydrochloride: IV"
393703|NCT00470067|P1|Participant Flow|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
carboplatin: IV
pegylated liposomal doxorubicin hydrochloride: IV"
393704|NCT00470067|O1|Outcome|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
carboplatin: IV
pegylated liposomal doxorubicin hydrochloride: IV"
393705|NCT00470067|E1|Reported Event|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
carboplatin: IV
pegylated liposomal doxorubicin hydrochloride: IV"
393706|NCT00470106|B5|Baseline|Total|Total of all reporting groups
393707|NCT00470106|B4|Baseline|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
393708|NCT00470106|B3|Baseline|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
393709|NCT00470106|B2|Baseline|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
393710|NCT00470106|B1|Baseline|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
393711|NCT00470106|P4|Participant Flow|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
393712|NCT00470106|P3|Participant Flow|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
393717|NCT00470106|O2|Outcome|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
393718|NCT00470106|O1|Outcome|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
393719|NCT00470106|O4|Outcome|Skills Training|"control training
skills training: Skills training in how to identify symptoms of illness and medication side effects."
393720|NCT00470106|O3|Outcome|Hybrid Intervention|"combined social cognitive and cognitive remediation training
hybrid intervention: A combination of the two groups listed above."
393721|NCT00470106|O2|Outcome|Cognitive Remediation|"cognitive remediation
Cognitive remediation: Computer exercises in attention, memory, and speed of processing."
393722|NCT00470106|O1|Outcome|Social Cognitive Skills Training|"social cognitive skills training
Social Cognitive skills training: Group training on emotion perception, social perception, and understanding others' mental states."
393723|NCT00470106|E4|Reported Event|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
393724|NCT00470106|E3|Reported Event|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
393725|NCT00470106|E2|Reported Event|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
393726|NCT00470106|E1|Reported Event|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
393727|NCT00470158|B6|Baseline|Total|Total of all reporting groups
393728|NCT00470158|B5|Baseline|Placebo|placebo daily
393729|NCT00470158|B4|Baseline|Zinc Alone|zinc, alternating daily with placebo
393730|NCT00470158|B3|Baseline|Iron Alone|iron, alternating daily with placebo
393731|NCT00470158|B2|Baseline|Separate Iron and Zinc|iron, alternating daily with zinc
393732|NCT00470158|B1|Baseline|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
393733|NCT00470158|P5|Participant Flow|Placebo|placebo daily
393734|NCT00470158|P4|Participant Flow|Zinc Alone|zinc, alternating daily with placebo
393735|NCT00470158|P3|Participant Flow|Iron Alone|iron, alternating daily with placebo
393736|NCT00470158|P2|Participant Flow|Separate Iron and Zinc|iron, alternating daily with zinc
393737|NCT00470158|P1|Participant Flow|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
393738|NCT00470158|O5|Outcome|Placebo|placebo daily
393739|NCT00470158|O4|Outcome|Zinc Alone|zinc, alternating daily with placebo
393740|NCT00470158|O3|Outcome|Iron Alone|iron, alternating daily with placebo
393741|NCT00470158|O2|Outcome|Separate Iron and Zinc|iron, alternating daily with zinc
393742|NCT00470158|O1|Outcome|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
393743|NCT00470158|E5|Reported Event|Placebo|placebo daily
393744|NCT00470158|E4|Reported Event|Zinc Alone|zinc, alternating daily with placebo
393745|NCT00470158|E3|Reported Event|Iron Alone|iron, alternating daily with placebo
393746|NCT00470158|E2|Reported Event|Separate Iron and Zinc|iron, alternating daily with zinc
393747|NCT00470158|E1|Reported Event|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
393748|NCT00470184|B1|Baseline|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
393749|NCT00470184|P1|Participant Flow|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
393750|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
393792|NCT00470418|O2|Outcome|Placebo|"Subjects with Alzheimer's Disease
Placebo: placebo comparator"
393793|NCT00470418|O1|Outcome|NIC5-15|"Subjects with Alzheimer's Disease
NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
393794|NCT00470418|O2|Outcome|Placebo|"Subjects with Alzheimer's Disease
Placebo: placebo comparator"
393881|NCT00470847|E1|Reported Event|Dose Level 2|n=27 participants Maximum Tolerated Dose 1250 mg lapatinib daily
393751|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
393752|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
393753|NCT00470184|O1|Outcome|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
393754|NCT00470184|E1|Reported Event|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
393755|NCT00470262|B3|Baseline|Total|Total of all reporting groups
393756|NCT00470262|B2|Baseline|Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD|Treatment with Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD in subjects with pre diabetes
393757|NCT00470262|B1|Baseline|Fenofibrate 145 mg PO QD|Treatment fenofibrate 145 mg PO QD in subjects with pre diabetes
393758|NCT00470262|P2|Participant Flow|Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD|Pioglitazone and Fenofibrate: Subjects will be randomized to a combination of both fenofibrate(145mg PO QD) and pioglitazone 45 mg PO QD
393759|NCT00470262|P1|Participant Flow|Fenofibrate|Treatment with fenofibrate 145mg PO QD
393760|NCT00470262|O2|Outcome|Fenofibrate 145mg PO QD + Pioglitazone 45mg PO BID|Treatment with pioglitazone and fenofibrate in subjects with pre diabetes
393761|NCT00470262|O1|Outcome|Fenofibrate 145mg PO QD|Treatment with fenofibrate in subjects with pre diabetes
393762|NCT00470262|O2|Outcome|Fenofibrate 145 mg PO QD + Pioglitazone|Treatment with fenofibrate and pioglitazone in subjects with pre diabetes
393763|NCT00470262|O1|Outcome|Fenofibrate 145mg PO QD|Treatment with fenofibrate in subjects with pre diabetes
393764|NCT00470262|E2|Reported Event|Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD|Treatment with fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD in subjects with pre diabetes
393765|NCT00470262|E1|Reported Event|Fenofibrate 145mg PO QD|Treatment with fenofibrate 145 mg PO QD in subjects with pre diabetes
393766|NCT00470275|B1|Baseline|Cytarbine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
393767|NCT00470275|P1|Participant Flow|Cytarbine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
393768|NCT00470275|O1|Outcome|Cytarabine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
393769|NCT00470275|E1|Reported Event|Cytarabine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
393770|NCT00470301|B1|Baseline|Arm I|"See Detailed Description
tipifarnib: Given orally
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
pegfilgrastim: Given SC
conventional surgery: surgical procedures performed on patients
axillary lymph node dissection: correlative study"
393771|NCT00470301|P1|Participant Flow|Arm I|"See Detailed Description
tipifarnib: Given orally
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
pegfilgrastim: Given SC
conventional surgery: surgical procedures performed on patients
axillary lymph node dissection: correlative study"
393772|NCT00470301|O1|Outcome|Arm I|"See Detailed Description
tipifarnib: Given orally
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
pegfilgrastim: Given SC
conventional surgery: surgical procedures performed on patients
axillary lymph node dissection: correlative study"
393773|NCT00470301|E1|Reported Event|Arm I|"See Detailed Description
tipifarnib: Given orally
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
pegfilgrastim: Given SC
conventional surgery: surgical procedures performed on patients
axillary lymph node dissection: correlative study"
393774|NCT00470392|B3|Baseline|Total|Total of all reporting groups
393775|NCT00470392|B2|Baseline|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
393776|NCT00470392|B1|Baseline|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
393777|NCT00470392|P2|Participant Flow|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
393778|NCT00470392|P1|Participant Flow|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
393779|NCT00470392|O2|Outcome|Clobetasol|"Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated."
393780|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
393781|NCT00470392|O2|Outcome|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point. No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated.
393782|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
393783|NCT00470392|O2|Outcome|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point. No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated.
393784|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
393785|NCT00470392|E2|Reported Event|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
393786|NCT00470392|E1|Reported Event|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
393787|NCT00470418|B3|Baseline|Total|Total of all reporting groups
393788|NCT00470418|B2|Baseline|Placebo|"Subjects with Alzheimer's Disease
Placebo: placebo comparator"
393789|NCT00470418|B1|Baseline|NIC5-15|"Subjects with Alzheimer's Disease
NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
393790|NCT00470418|P2|Participant Flow|Placebo|"Placebo: placebo comparator identical in pill size, appearance and number
Subjects with Alzheimer's Disease"
393791|NCT00470418|P1|Participant Flow|NIC5-15|"NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects. Subjects received escalating doses of 1500, 3000 and 5000 mg daily over the course of the study.
Subjects with Alzheimer's Disease"
393795|NCT00470418|O1|Outcome|NIC5-15|"Subjects with Alzheimer's Disease
NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
393796|NCT00470418|E2|Reported Event|Placebo|"Subjects with Alzheimer's Disease
Placebo: placebo comparator"
393797|NCT00470418|E1|Reported Event|NIC5-15|"Subjects with Alzheimer's Disease
NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
393798|NCT00470470|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies"
393799|NCT00470470|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies"
393800|NCT00470470|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies"
393801|NCT00470470|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies"
393802|NCT00470470|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies"
393803|NCT00470535|B1|Baseline|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
393804|NCT00470535|P1|Participant Flow|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
393805|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
393806|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
393807|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
393808|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
393809|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
393810|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
393811|NCT00470535|E1|Reported Event|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
393812|NCT00470548|B3|Baseline|Total|Total of all reporting groups
393813|NCT00470548|B2|Baseline|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
393814|NCT00470548|B1|Baseline|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
393815|NCT00470548|P4|Participant Flow|Phase II|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
393816|NCT00470548|P3|Participant Flow|Phase I: Dose Level 3|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
393817|NCT00470548|P2|Participant Flow|Phase I: Dose Level 2|Pemetrexed 500 mg/m2 plus Abraxane 220 mg/m2
393818|NCT00470548|P1|Participant Flow|Phase I: Dose Level 1|Pemetrexed 500 mg/m2 plus Abraxane 180 mg/m2
393819|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
393820|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
393821|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
393822|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
393823|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
393824|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
393825|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
393826|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
393827|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
393828|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
393829|NCT00470548|O1|Outcome|Phase II: Pemetrexed and Abraxane|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
393830|NCT00470548|O3|Outcome|Phase I: Dose Level 3|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
393831|NCT00470548|O2|Outcome|Phase I: Dose Level 2|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 220 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
393832|NCT00470548|O1|Outcome|Phase I: Dose Level 1|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
393833|NCT00470548|E2|Reported Event|Phase II: Abraxane and Alimta|"Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 260 mg/m2 every 21 days.
Abraxane: ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)
Alimta: Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)"
393834|NCT00470548|E1|Reported Event|Phase I: Abraxane and Alimta|"Three dose levels were tested. Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 180, 220, and 260 mg/m2 every 21 days.
Abraxane: ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)
Alimta: Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)"
393835|NCT00470600|B3|Baseline|Total|Total of all reporting groups
393836|NCT00470600|B2|Baseline|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
393837|NCT00470600|B1|Baseline|Placebo|250 mL of normal saline.
393838|NCT00470600|P2|Participant Flow|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
393839|NCT00470600|P1|Participant Flow|Placebo|250 mL of normal saline.
393840|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
393841|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
393842|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
393843|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
393844|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
393845|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
393846|NCT00470600|E2|Reported Event|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
393847|NCT00470600|E1|Reported Event|Placebo|250 mL of normal saline.
393848|NCT00470626|B1|Baseline|Celect Vena Cava Filter|
393849|NCT00470626|P1|Participant Flow|Celect Vena Cava Filter|
393850|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
393851|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
393852|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
393853|NCT00470626|E1|Reported Event|Celect Vena Cava Filter|
393854|NCT00470834|B3|Baseline|Total|Total of all reporting groups
393855|NCT00470834|B2|Baseline|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393856|NCT00470834|B1|Baseline|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393857|NCT00470834|P2|Participant Flow|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393858|NCT00470834|P1|Participant Flow|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393859|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393860|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393880|NCT00470847|E2|Reported Event|Dose Level 1|n=3 participants 1000 mg lapatinib daily
421255|NCT00540124|O1|Outcome|Placebo|by mouth once a day
393861|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393862|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393863|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393864|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393865|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393866|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393867|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393868|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393869|NCT00470834|E2|Reported Event|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393870|NCT00470834|E1|Reported Event|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
393871|NCT00470847|B1|Baseline|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
393872|NCT00470847|P1|Participant Flow|Lapatinib,Whole Brain Radiation,Herceptin|Participants received lapatinib, orally, 750mg twice on day one followed by 1000mg, 1250mg, or 1500mg once daily. Whole Brain Radiation therapy (WBRT) (37.5 Gy, 15 fractions) began 1-8 days after starting lapatinib. Lapatinib was continued through WBRT. Following WBRT, patients received trastuzumab intravenously 2mg/kg weekly and lapatinib 1000mg orally once daily.
393873|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
393874|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
393875|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
393876|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
393877|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
393878|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
393879|NCT00470847|E3|Reported Event|Dose Level 3|n=5 participants 1500 mg lapatinib daily
393892|NCT00471107|B3|Baseline|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
393893|NCT00471107|B2|Baseline|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
393894|NCT00471107|B1|Baseline|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
393895|NCT00471107|P3|Participant Flow|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
393896|NCT00471107|P2|Participant Flow|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
393897|NCT00471107|P1|Participant Flow|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
393898|NCT00471107|O3|Outcome|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
393899|NCT00471107|O2|Outcome|Left Prefrontal Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
393900|NCT00471107|O1|Outcome|Left Prefrontal Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
393901|NCT00471107|E3|Reported Event|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
393902|NCT00471107|E2|Reported Event|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
393903|NCT00471107|E1|Reported Event|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
393904|NCT00471146|B3|Baseline|Total|Total of all reporting groups
393905|NCT00471146|B2|Baseline|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393906|NCT00471146|B1|Baseline|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393907|NCT00471146|P2|Participant Flow|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393908|NCT00471146|P1|Participant Flow|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) in cycles of 4 weeks. Gemcitabine 1000 mg per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393909|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393910|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393911|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393912|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393913|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393914|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393915|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393916|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393917|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393918|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393919|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393920|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
421256|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
393921|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393922|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393923|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
394113|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
393924|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393925|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393926|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393927|NCT00471146|E2|Reported Event|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393928|NCT00471146|E1|Reported Event|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
393929|NCT00471276|B1|Baseline|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393930|NCT00471276|P1|Participant Flow|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393931|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393932|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393933|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393934|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393935|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393936|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393937|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393938|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393939|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393940|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393941|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393942|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393943|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393944|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393945|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393946|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393947|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393948|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393949|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
394107|NCT00461786|B1|Baseline|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
393950|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393951|NCT00471276|E1|Reported Event|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
393952|NCT00471315|B1|Baseline|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
393953|NCT00471315|P1|Participant Flow|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
393954|NCT00471315|O1|Outcome|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
393955|NCT00471315|O1|Outcome|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
393956|NCT00471315|E1|Reported Event|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
393957|NCT00471328|B3|Baseline|Total|Total of all reporting groups
393958|NCT00471328|B2|Baseline|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
393959|NCT00471328|B1|Baseline|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
393960|NCT00471328|P2|Participant Flow|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
393961|NCT00471328|P1|Participant Flow|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
393962|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
393963|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
393964|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
393965|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
393966|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
393967|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
393968|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
393969|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
393970|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
393971|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
393972|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
393973|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
393974|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.
Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
393975|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
394108|NCT00461786|P1|Participant Flow|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
393976|NCT00471328|E3|Reported Event|Crossover Nilotinib Therapy|All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression were included in safety assessment.
393977|NCT00471328|E2|Reported Event|Control(Core + Extension)|Patients randomized to control arm, Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose before the study or at the dose of the investigator’s choice. The safety is assessed using these patient’s data from both core and extension phase of the study.
394989|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
393978|NCT00471328|E1|Reported Event|Nilotinib(Core +Extension)|Patients randomized to 400 mg Nilotinib which was taken orally twice daily. The safety is assessed using these patient’s data from both core and extension phase of the study.
393979|NCT00471354|B1|Baseline|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
393980|NCT00471354|P1|Participant Flow|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
393981|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
393982|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
393983|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
393984|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
393985|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
393986|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
393987|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
393988|NCT00471354|E1|Reported Event|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
393989|NCT00461591|B3|Baseline|Total|Total of all reporting groups
393990|NCT00461591|B2|Baseline|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
393991|NCT00461591|B1|Baseline|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
393992|NCT00461591|P2|Participant Flow|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
393993|NCT00461591|P1|Participant Flow|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
393994|NCT00461591|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
393995|NCT00461591|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
393996|NCT00461591|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
393997|NCT00461591|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
393998|NCT00461591|E2|Reported Event|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
393999|NCT00461591|E1|Reported Event|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
394000|NCT00461630|B3|Baseline|Total|Total of all reporting groups
394001|NCT00461630|B2|Baseline|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394002|NCT00461630|B1|Baseline|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394003|NCT00461630|P2|Participant Flow|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394004|NCT00461630|P1|Participant Flow|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394005|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394006|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394007|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394008|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394009|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394010|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394011|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394012|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394013|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394014|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394114|NCT00461786|E1|Reported Event|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
394015|NCT00461630|E2|Reported Event|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394016|NCT00461630|E1|Reported Event|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
394017|NCT00461682|B1|Baseline|Overall Study Arm|
394018|NCT00461682|P1|Participant Flow|Total Population|Eligible participants were planned to receive oral SB-705498 eight hundred (800) milligrams (mg) once daily or matching Placebo in a randomized manner over two treatment periods once in the study. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394019|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394020|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
394021|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394022|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
394023|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394024|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
394025|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394026|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
394027|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394028|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
394029|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394030|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
394031|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394032|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
394033|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394034|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
394035|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394036|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
394037|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394038|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
394039|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394040|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
421257|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
394041|NCT00461682|E2|Reported Event|SB-705498|Participants were planned to receive oral SB-705498 800 milligrams (mg) once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
394115|NCT00471380|B1|Baseline|Overall Study Population|
394990|NCT00474630|O2|Outcome|Placebo|Placebo
394042|NCT00461682|E1|Reported Event|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
394043|NCT00461708|B3|Baseline|Total|Total of all reporting groups
394044|NCT00461708|B2|Baseline|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394045|NCT00461708|B1|Baseline|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394046|NCT00461708|P2|Participant Flow|Erlotinib, Gemcitabine: Rash Grade Greater Than/Equal to (≥) 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394047|NCT00461708|P1|Participant Flow|Erlotinib, Gemcitabine: Rash Grade Less Than (<) 2|Participants with a rash Grade < 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (V) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394048|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394049|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394050|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394051|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394052|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394053|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394054|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394109|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
394110|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
394111|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
394983|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394167|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
448582|NCT00606489|P2|Participant Flow|800mg Intravenous Ibuprofen|
394055|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394056|NCT00461708|O3|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394057|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade 1|Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394058|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade 0|Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394059|NCT00461708|O3|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394060|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade 1|Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394061|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade 0|Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394062|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394063|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394064|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394065|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394066|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394067|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394112|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
394984|NCT00474630|O2|Outcome|Placebo|Placebo
394068|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394069|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394070|NCT00461708|E2|Reported Event|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394071|NCT00461708|E1|Reported Event|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
394072|NCT00461734|B3|Baseline|Total|Total of all reporting groups
394073|NCT00461734|B2|Baseline|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
394074|NCT00461734|B1|Baseline|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
394075|NCT00461734|P2|Participant Flow|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
394076|NCT00461734|P1|Participant Flow|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
394077|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
394078|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
394079|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
394080|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
394081|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
394082|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
394083|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
394084|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
394085|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to trat cohort)
394086|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
394087|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
394088|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
394089|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
394090|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
394091|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
394092|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
394093|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
394094|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
394095|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
394096|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
394097|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
394098|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
394099|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
394100|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
394101|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
394102|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
394103|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
394104|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
394105|NCT00461734|E2|Reported Event|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
394106|NCT00461734|E1|Reported Event|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
394116|NCT00471380|P2|Participant Flow|Crossover Group BAA|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
394117|NCT00471380|P1|Participant Flow|Crossover Group ABB|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
394118|NCT00471380|O2|Outcome|Crossover Group BAA|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
394119|NCT00471380|O1|Outcome|Crossover Group ABB|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
394120|NCT00471380|E2|Reported Event|Treatment B|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).
394121|NCT00471380|E1|Reported Event|Treatment A|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.).
394122|NCT00471445|B3|Baseline|Total|Total of all reporting groups
394123|NCT00471445|B2|Baseline|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
placebo: Applied topically"
394124|NCT00471445|B1|Baseline|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
ketamine/amitriptyline NP-H cream: Applied topically"
394125|NCT00471445|P2|Participant Flow|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
placebo: Applied topically"
394126|NCT00471445|P1|Participant Flow|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
ketamine/amitriptyline NP-H cream: Applied topically"
394127|NCT00471445|O2|Outcome|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
placebo: Applied topically"
394128|NCT00471445|O1|Outcome|Ketamine/Amitriptyline NP-H Cream|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
ketamine/amitriptyline NP-H cream: Applied topically"
394129|NCT00471445|E2|Reported Event|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
placebo: Applied topically"
394130|NCT00471445|E1|Reported Event|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
ketamine/amitriptyline NP-H cream: Applied topically"
394131|NCT00471497|B4|Baseline|Total|Total of all reporting groups
394132|NCT00471497|B3|Baseline|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
394133|NCT00471497|B2|Baseline|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
421258|NCT00540124|O1|Outcome|Placebo|by mouth once a day
394168|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394200|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
394134|NCT00471497|B1|Baseline|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
394135|NCT00471497|P3|Participant Flow|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
394136|NCT00471497|P2|Participant Flow|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
394137|NCT00471497|P1|Participant Flow|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
394138|NCT00471497|O3|Outcome|Nilotinib 400mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
394139|NCT00471497|O2|Outcome|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
394140|NCT00471497|O1|Outcome|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
394141|NCT00471497|E3|Reported Event|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
394142|NCT00471497|E2|Reported Event|Nilotinib 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
394166|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
421259|NCT00540124|E3|Reported Event|Tamsulosin|0.2 mg by mouth once a day
394143|NCT00471497|E1|Reported Event|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
394144|NCT00471536|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
394145|NCT00471536|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
394146|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
394147|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
394148|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
394149|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
394150|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
394151|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
394152|NCT00471536|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
394153|NCT00473512|B6|Baseline|Total|Total of all reporting groups
394154|NCT00473512|B5|Baseline|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394155|NCT00473512|B4|Baseline|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394156|NCT00473512|B3|Baseline|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394157|NCT00473512|B2|Baseline|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394158|NCT00473512|B1|Baseline|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394159|NCT00473512|P5|Participant Flow|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394160|NCT00473512|P4|Participant Flow|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394161|NCT00473512|P3|Participant Flow|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394162|NCT00473512|P2|Participant Flow|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394163|NCT00473512|P1|Participant Flow|250 mg/Day|Abiraterone acetate 250 milligram (mg) capsule administered orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. Participants received MTD (1000 mg) of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394164|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394165|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394169|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394170|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394171|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394172|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394173|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394174|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394175|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394176|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394177|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394178|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394179|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394180|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394181|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394182|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394183|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394184|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394185|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394186|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394187|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394188|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394189|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394190|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394191|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394192|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394193|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394194|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394195|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394196|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394197|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394198|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
394199|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
394244|NCT00473642|B4|Baseline|Total|Total of all reporting groups
394201|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
394202|NCT00473512|O5|Outcome|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394203|NCT00473512|O4|Outcome|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394204|NCT00473512|O3|Outcome|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394205|NCT00473512|O2|Outcome|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394206|NCT00473512|O1|Outcome|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394207|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
394208|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
394209|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
394210|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
394211|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
394212|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
394213|NCT00473512|O2|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
394214|NCT00473512|O1|Outcome|1000 mg AA Monotherapy|Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
394215|NCT00473512|E5|Reported Event|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394216|NCT00473512|E4|Reported Event|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394217|NCT00473512|E3|Reported Event|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394218|NCT00473512|E2|Reported Event|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394219|NCT00473512|E1|Reported Event|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
394220|NCT00473564|B1|Baseline|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
394221|NCT00473564|P1|Participant Flow|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
394222|NCT00473564|O1|Outcome|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
394223|NCT00473564|O1|Outcome|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
394224|NCT00473564|E1|Reported Event|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
394225|NCT00473590|B3|Baseline|Total|Total of all reporting groups
394226|NCT00473590|B2|Baseline|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
394607|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394227|NCT00473590|B1|Baseline|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
394245|NCT00473642|B3|Baseline|Ranibizumab|Ranibizumab monotherapy
394228|NCT00473590|P2|Participant Flow|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
394229|NCT00473590|P1|Participant Flow|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
394230|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
394231|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
394232|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
394233|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
394234|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
394235|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
394236|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
394237|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
394238|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
394239|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
394240|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
394241|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
394242|NCT00473590|E2|Reported Event|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
394404|NCT00473824|B2|Baseline|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
394243|NCT00473590|E1|Reported Event|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
394246|NCT00473642|B2|Baseline|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
394247|NCT00473642|B1|Baseline|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
394248|NCT00473642|P3|Participant Flow|Ranibizumab|Ranibizumab monotherapy
394249|NCT00473642|P2|Participant Flow|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
394250|NCT00473642|P1|Participant Flow|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
394251|NCT00473642|O3|Outcome|Ranibizumab|Ranibizumab monotherapy
394252|NCT00473642|O2|Outcome|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
394253|NCT00473642|O1|Outcome|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
394254|NCT00473642|E3|Reported Event|Ranibizumab|Ranibizumab monotherapy
394255|NCT00473642|E2|Reported Event|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
394256|NCT00473642|E1|Reported Event|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
394257|NCT00473655|B4|Baseline|Total|Total of all reporting groups
394258|NCT00473655|B3|Baseline|Placebo|Placebo
394259|NCT00473655|B2|Baseline|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394260|NCT00473655|B1|Baseline|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394261|NCT00473655|P3|Participant Flow|Placebo|Placebo
394262|NCT00473655|P2|Participant Flow|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394263|NCT00473655|P1|Participant Flow|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394264|NCT00473655|O3|Outcome|Placebo|Placebo
394265|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394266|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394267|NCT00473655|O3|Outcome|Placebo|Placebo
394268|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394269|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394270|NCT00473655|O3|Outcome|Placebo|Placebo
394271|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394272|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394273|NCT00473655|O3|Outcome|Placebo|Placebo
394274|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394275|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394276|NCT00473655|O3|Outcome|Placebo|Placebo
394277|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394278|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394279|NCT00473655|O3|Outcome|Placebo|Placebo
394280|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394281|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394282|NCT00473655|O3|Outcome|Placebo|Placebo
394283|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394284|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394285|NCT00473655|O3|Outcome|Placebo|Placebo
394286|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394287|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394288|NCT00473655|O3|Outcome|Placebo|Placebo
394289|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394290|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394291|NCT00473655|E3|Reported Event|Placebo|Placebo
394292|NCT00473655|E2|Reported Event|Rosuvastatin 20 mg|Rosuvastatin 20 mg
394293|NCT00473655|E1|Reported Event|Rosuvastatin 10 mg|Rosuvastatin 10 mg
394294|NCT00473668|B4|Baseline|Total|Total of all reporting groups
394295|NCT00473668|B3|Baseline|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394296|NCT00473668|B2|Baseline|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394297|NCT00473668|B1|Baseline|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394298|NCT00473668|P3|Participant Flow|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394299|NCT00473668|P2|Participant Flow|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394300|NCT00473668|P1|Participant Flow|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394301|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394302|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394303|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394304|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394305|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394306|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394307|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394308|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394309|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394310|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394311|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394312|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394313|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394314|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394315|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394316|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394317|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394318|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394319|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394320|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394321|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394322|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394323|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394324|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394325|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394326|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394327|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394328|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394362|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
394329|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394330|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394331|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394332|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394333|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394334|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394335|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394336|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394337|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394338|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394339|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394340|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394341|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394342|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394343|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394344|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394345|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394346|NCT00473668|E3|Reported Event|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394347|NCT00473668|E2|Reported Event|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394348|NCT00473668|E1|Reported Event|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
394349|NCT00473746|B6|Baseline|Total|Total of all reporting groups
394350|NCT00473746|B5|Baseline|Phase 2 1000 MG/DAY|Abiraterone acetate
394351|NCT00473746|B4|Baseline|Phase 1 1000 MG/DAY|Abiraterone acetate
394352|NCT00473746|B3|Baseline|Phase 1 750 MG/DAY|Abiraterone acetate
394353|NCT00473746|B2|Baseline|Phase 1 500 MG/DAY|Abiraterone acetate
394354|NCT00473746|B1|Baseline|Phase 1 250 MG/DAY|Abiraterone acetate
394355|NCT00473746|P5|Participant Flow|Phase 2 1000 MG/DAY|Abiraterone acetate
394356|NCT00473746|P4|Participant Flow|Phase 1 1000 MG/DAY|Abiraterone acetate
394357|NCT00473746|P3|Participant Flow|Phase 1 750 MG/DAY|Abiraterone acetate
394358|NCT00473746|P2|Participant Flow|Phase 1 500 MG/DAY|Abiraterone acetate
394359|NCT00473746|P1|Participant Flow|Phase 1 250 MG/DAY|Abiraterone acetate
394360|NCT00473746|O1|Outcome|Phase II Dose Treatment|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
394361|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
394401|NCT00473746|E2|Reported Event|Phase 1 500 MG/DAY|Abiraterone acetate
394402|NCT00473746|E1|Reported Event|Phase 1 250 MG/DAY|Abiraterone acetate
394363|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
394364|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
394365|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
394366|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
394367|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
394368|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
394369|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
394370|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
394371|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
394372|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
394373|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
394374|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
394375|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
394376|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
394377|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
394378|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
394379|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
394380|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
394381|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
394382|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
394383|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
394384|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
394385|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
394386|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
394387|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
394388|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
394389|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
394390|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
394391|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
394392|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
394393|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
394394|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
394395|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
394396|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
394397|NCT00473746|O1|Outcome|Phase I Dose Escalation|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
394398|NCT00473746|E5|Reported Event|Phase 2 1000 MG/DAY|Abiraterone acetate
394399|NCT00473746|E4|Reported Event|Phase 1 1000 MG/DAY|Abiraterone acetate
394400|NCT00473746|E3|Reported Event|Phase 1 750 MG/DAY|Abiraterone acetate
394405|NCT00473824|B1|Baseline|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
394406|NCT00473824|P2|Participant Flow|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
394407|NCT00473824|P1|Participant Flow|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
394408|NCT00473824|O2|Outcome|No Civacir (Control)|Observation on standard site specific routine post-tranplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%. Standard post-tranplant therapy includes immunosuppressive agents.
394409|NCT00473824|O1|Outcome|Civacir Treatment Arm|Subjects received Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight, in addition to their standard site specific routine post-tranplant immunosuppressant therapy.
394410|NCT00473824|E2|Reported Event|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
394411|NCT00473824|E1|Reported Event|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
394412|NCT00473837|B3|Baseline|Total|Total of all reporting groups
394413|NCT00473837|B2|Baseline|Control|Subjects initially treated with Co-artemether or Chloroquine & Sulphadoxine/Pyrimathamine, and then continued on weekly placebo till day 90
394414|NCT00473837|B1|Baseline|Treatment|Subjects initially treated with Co-artemether or Chloroquine &Sulphadoxine/Pyrimathamine, and then continued on weekly chloroquine till day 90
394415|NCT00473837|P2|Participant Flow|Control|Subjects initially treated with Co-artemether or Cholroquine & Sulphadoxine/Pyrimethamine, and then continued on weekly placebo till day 90.
394416|NCT00473837|P1|Participant Flow|Treatment|Subjects initially treated with Corartemether or Cholroquine & Sulphadoxine/Pyrimethamine, and then continued on weekly chloroquine till day 90.
394417|NCT00473837|O2|Outcome|Control|"Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90
Placebo: The placebo is an orange syrup in a 60ml amber coloured glass bottle containing sucrose syrup base. The syrup was prepared by the Pharmacy department of the Royal Victorial Teaching Hospital and Atlantic Pharmaceuticals Limited, Banjul"
394418|NCT00473837|O1|Outcome|Treatment|"Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90
Chloroquine: This is an orange syrup in a 60ml amber coloured glass bottle containing 50mg of chloroquine base per 5mls as the chloroquine phosphate. The syrup was manufactured by Medreich Sterilab Ltd, Avalahalli, Bangalore, India. Chloroquine: weekly treatment of 7.5mg/kg for 90 days"
394419|NCT00473837|E2|Reported Event|Control|Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90
394420|NCT00473837|E1|Reported Event|Treatment|Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90
394421|NCT00473876|B3|Baseline|Total|Total of all reporting groups
394422|NCT00473876|B2|Baseline|Placebo|Matched Placebo for 4 months
394423|NCT00473876|B1|Baseline|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
394424|NCT00473876|P2|Participant Flow|Placebo|Matched Placebo for 4 months
394425|NCT00473876|P1|Participant Flow|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
394426|NCT00473876|O2|Outcome|Placebo|Impact of placebo on VE/VCO2 slope.
394427|NCT00473876|O1|Outcome|Metformin Arm|Assess impact of metformin on submaximal exercise parameters- VE/VCO2 slope (pre-specified end point). The mean VE/VCO2 difference was compared between baseline and after 4 months of metformin.
394428|NCT00473876|O2|Outcome|Placebo|Peak VO2 mean difference between baseline and after 4 months of placebo
394429|NCT00473876|O1|Outcome|Metformin Arm|Peak VO2 mean difference between baseline and after 4 months of metformin was analysed
394430|NCT00473876|E2|Reported Event|Placebo|Matched Placebo for 4 months
394431|NCT00473876|E1|Reported Event|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
394432|NCT00473889|B3|Baseline|Total|Total of all reporting groups
394433|NCT00473889|B2|Baseline|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394434|NCT00473889|B1|Baseline|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394435|NCT00473889|P2|Participant Flow|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394436|NCT00473889|P1|Participant Flow|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394597|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394598|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394437|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394608|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394438|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394439|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394440|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394441|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394442|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394443|NCT00473889|E2|Reported Event|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394444|NCT00473889|E1|Reported Event|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
394445|NCT00474045|B3|Baseline|Total|Total of all reporting groups
394446|NCT00474045|B2|Baseline|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394447|NCT00474045|B1|Baseline|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394448|NCT00474045|P2|Participant Flow|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394449|NCT00474045|P1|Participant Flow|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394450|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394451|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394452|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394599|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394609|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394610|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394991|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394453|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394454|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394455|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394456|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394457|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394458|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394459|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394460|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394461|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394462|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394463|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394464|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394465|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394600|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394466|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394467|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394468|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394469|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394470|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394471|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394472|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394473|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394474|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394475|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394476|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394477|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394478|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394601|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394479|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394480|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394481|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394482|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394483|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394484|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394485|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394486|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394487|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394488|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394489|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394490|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394491|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394602|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
421260|NCT00540124|E2|Reported Event|Tadalafil|5 mg by mouth once a day
394492|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394493|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394494|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394495|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394496|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394497|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394498|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394499|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394500|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394501|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394502|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394503|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394504|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394603|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394505|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394506|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394507|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394508|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394509|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394510|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394511|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394512|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394513|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394514|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394515|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394516|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394517|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394604|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
421261|NCT00540124|E1|Reported Event|Placebo|by mouth once a day
394518|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394519|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394520|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394521|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394522|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394523|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394524|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394525|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394526|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394527|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394528|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394529|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394530|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394605|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394531|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394532|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394533|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394534|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394535|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394536|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394537|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394538|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394539|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394540|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394541|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394542|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394543|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394606|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394544|NCT00474045|E2|Reported Event|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394545|NCT00474045|E1|Reported Event|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
394546|NCT00474058|B3|Baseline|Total|Total of all reporting groups
394547|NCT00474058|B2|Baseline|Placebo|Placebo transdermal patch
394548|NCT00474058|B1|Baseline|Rotigotine|Rotigotine transdermal patch
394549|NCT00474058|P2|Participant Flow|Placebo|Placebo transdermal patch
394550|NCT00474058|P1|Participant Flow|Rotigotine|Rotigotine transdermal patch
394551|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
394552|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
394553|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
394554|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
394555|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
394556|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
394557|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
394558|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
394559|NCT00474058|E2|Reported Event|Placebo|Placebo transdermal patch
394560|NCT00474058|E1|Reported Event|Rotigotine|Rotigotine transdermal patch
394561|NCT00474123|B3|Baseline|Total|Total of all reporting groups
394562|NCT00474123|B2|Baseline|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394563|NCT00474123|B1|Baseline|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394564|NCT00474123|P2|Participant Flow|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394565|NCT00474123|P1|Participant Flow|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394566|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394567|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394568|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394569|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394570|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394571|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394572|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394573|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394574|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394575|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394576|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394577|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394578|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394579|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394580|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394581|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394582|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394583|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394584|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394585|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394586|NCT00474123|E2|Reported Event|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
394587|NCT00474123|E1|Reported Event|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
394588|NCT00474175|B4|Baseline|Total|Total of all reporting groups
394589|NCT00474175|B3|Baseline|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394590|NCT00474175|B2|Baseline|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394591|NCT00474175|B1|Baseline|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394592|NCT00474175|P3|Participant Flow|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394593|NCT00474175|P2|Participant Flow|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394594|NCT00474175|P1|Participant Flow|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394595|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394596|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394611|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394612|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394613|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394614|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394615|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394616|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394617|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394618|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394619|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394620|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394621|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394622|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394623|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394624|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394625|NCT00474175|E3|Reported Event|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
394626|NCT00474175|E2|Reported Event|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
394627|NCT00474175|E1|Reported Event|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
394628|NCT00474188|B1|Baseline|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
394629|NCT00474188|P1|Participant Flow|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
394630|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
394631|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
394632|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
394633|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
394634|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
394635|NCT00474201|B1|Baseline|Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.
394636|NCT00474201|P1|Participant Flow|Gemfibrozil (GF) Alone Followed by GF+ Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected to determine gemfibrozil plasma concentrations. These plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameter values such as area under the concentration vs. time curve (AUC). Gemfibrozil PK parameter values were then compared before- and after lopinavir-ritonavir administration.
394637|NCT00474201|O2|Outcome|Gemfibrozil + Lopinavir-ritonavir|After receiving lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days, subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest.
394638|NCT00474201|O1|Outcome|Gemfibrozil Alone (Control Group)|"Subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest. After completing participation in this control group, each subject crossed over to received lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days. Therefore, each subject served as their own control. Hence there were two groups of data analyzed, but each group consisted of the same subjects (tested under different conditions)."
394933|NCT00474539|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
394679|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
394992|NCT00474630|O2|Outcome|Placebo|Placebo
394639|NCT00474201|E1|Reported Event|Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.
394640|NCT00474240|B7|Baseline|Total|Total of all reporting groups
394641|NCT00474240|B6|Baseline|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
394642|NCT00474240|B5|Baseline|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
394643|NCT00474240|B4|Baseline|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
394644|NCT00474240|B3|Baseline|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
394645|NCT00474240|B2|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
394646|NCT00474240|B1|Baseline|Placebo|Placebo capsule taken orally once daily
394647|NCT00474240|P6|Participant Flow|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
394648|NCT00474240|P5|Participant Flow|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
394649|NCT00474240|P4|Participant Flow|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
394650|NCT00474240|P3|Participant Flow|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
394651|NCT00474240|P2|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
394652|NCT00474240|P1|Participant Flow|Placebo|Placebo capsule taken orally once daily
394653|NCT00474240|O6|Outcome|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
394654|NCT00474240|O5|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
394655|NCT00474240|O4|Outcome|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
394656|NCT00474240|O3|Outcome|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
394657|NCT00474240|O2|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
394658|NCT00474240|O1|Outcome|Placebo|Placebo capsule taken orally once daily
394659|NCT00474240|O6|Outcome|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
394660|NCT00474240|O5|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
394661|NCT00474240|O4|Outcome|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
394662|NCT00474240|O3|Outcome|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
394663|NCT00474240|O2|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
394664|NCT00474240|O1|Outcome|Placebo|Placebo capsule taken orally once daily
394665|NCT00474240|E6|Reported Event|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
394666|NCT00474240|E5|Reported Event|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
394667|NCT00474240|E4|Reported Event|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
394668|NCT00474240|E3|Reported Event|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
394669|NCT00474240|E2|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
394670|NCT00474240|E1|Reported Event|Placebo|Placebo capsule taken orally once daily
394671|NCT00474383|B1|Baseline|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
394672|NCT00474383|P2|Participant Flow|Arbitarone Acetate (Extension)|Participants who received abiraterone acetate 1000 milligram (mg) capsule or tablet orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily in Main study, continued the same treatment until disease progression, death, or end of study (Week 148).
394673|NCT00474383|P1|Participant Flow|Abiraterone Acetate (Main Study)|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
394674|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
394675|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
394676|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
394677|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
394678|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
394980|NCT00474630|O2|Outcome|Placebo|Placebo
394680|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
394681|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
394682|NCT00474383|E1|Reported Event|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
394683|NCT00474487|B5|Baseline|Total|Total of all reporting groups
394684|NCT00474487|B4|Baseline|Licensed Polysaccharide Vaccine (56 to 65 Years)|One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
394685|NCT00474487|B3|Baseline|Licensed Conjugate Vaccine (19 to 55 Years)|One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
394686|NCT00474487|B2|Baseline|Novartis MenACWY Vaccine (56 to 65 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
394687|NCT00474487|B1|Baseline|Novartis MenACWY Vaccine (19 to 55 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
394688|NCT00474487|P4|Participant Flow|Licensed Polysaccharide Vaccine (56 to 65 Years)|One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
394689|NCT00474487|P3|Participant Flow|Licensed Conjugate Vaccine (19 to 55 Years)|One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
394690|NCT00474487|P2|Participant Flow|Novartis MenACWY Vaccine (56 to 65 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
394691|NCT00474487|P1|Participant Flow|Novartis MenACWY Vaccine (19 to 55 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
394692|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly.
394693|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
394694|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
394695|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
394696|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine administered subcutaneously.
394697|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
394698|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
394699|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
394700|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine administered subcutaneously.
394701|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
394702|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
394703|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
394704|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
394705|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
394706|NCT00474487|E4|Reported Event|Licensed Polysaccharide Vaccine (56 to 65 Years)|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly (Ages 56 to 65 Years)
394707|NCT00474487|E3|Reported Event|Licensed Conjugate Vaccine (19 to 55 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly in ages 19 to 55 years.
394708|NCT00474487|E2|Reported Event|Novartis MenACWY Vaccine (56 to 65 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
394709|NCT00474487|E1|Reported Event|Novartis MenACWY Vaccine (19 to 55 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
394710|NCT00474526|B18|Baseline|TOTAL|Total of all reporting groups
394711|NCT00474526|B17|Baseline|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
394712|NCT00474526|B16|Baseline|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
394785|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
394713|NCT00474526|B15|Baseline|LA6A (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
394714|NCT00474526|B14|Baseline|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
394715|NCT00474526|B13|Baseline|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394716|NCT00474526|B12|Baseline|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
394717|NCT00474526|B11|Baseline|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
394718|NCT00474526|B10|Baseline|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394719|NCT00474526|B9|Baseline|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
394720|NCT00474526|B8|Baseline|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394721|NCT00474526|B7|Baseline|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
394722|NCT00474526|B6|Baseline|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
394723|NCT00474526|B5|Baseline|US4A (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394724|NCT00474526|B4|Baseline|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394725|NCT00474526|B3|Baseline|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394726|NCT00474526|B2|Baseline|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
394727|NCT00474526|B1|Baseline|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
394728|NCT00474526|P17|Participant Flow|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
394729|NCT00474526|P16|Participant Flow|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
394730|NCT00474526|P15|Participant Flow|LA6A (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
394929|NCT00474539|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
394981|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394731|NCT00474526|P14|Participant Flow|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
394732|NCT00474526|P13|Participant Flow|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394733|NCT00474526|P12|Participant Flow|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
394734|NCT00474526|P11|Participant Flow|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
394735|NCT00474526|P10|Participant Flow|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394736|NCT00474526|P9|Participant Flow|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
394737|NCT00474526|P8|Participant Flow|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394738|NCT00474526|P7|Participant Flow|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
394739|NCT00474526|P6|Participant Flow|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
394740|NCT00474526|P5|Participant Flow|US4A (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394741|NCT00474526|P4|Participant Flow|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394742|NCT00474526|P3|Participant Flow|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394743|NCT00474526|P2|Participant Flow|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
394744|NCT00474526|P1|Participant Flow|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
394745|NCT00474526|O2|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394746|NCT00474526|O1|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394747|NCT00474526|O2|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394748|NCT00474526|O1|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394982|NCT00474630|O2|Outcome|Placebo|Placebo
421262|NCT00540228|B6|Baseline|Total|Total of all reporting groups
394749|NCT00474526|O2|Outcome|LA3B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
394750|NCT00474526|O1|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
394751|NCT00474526|O2|Outcome|LA3B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
394752|NCT00474526|O1|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
394753|NCT00474526|O2|Outcome|LA1B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
394754|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394755|NCT00474526|O2|Outcome|LA1B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
394756|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394757|NCT00474526|O3|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394758|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
394759|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
394760|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
394761|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
394762|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
394763|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394764|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
394765|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394784|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394766|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
394767|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394768|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
394769|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394770|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394771|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
394772|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394773|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
394774|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394775|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
394776|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394777|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
394778|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394779|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
394780|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394781|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
394782|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394783|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
394930|NCT00474539|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
394786|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394787|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
394788|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394789|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
394790|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394791|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
394792|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394793|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
394794|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394795|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
394796|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394797|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
394798|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394799|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
394800|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394801|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
394802|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394803|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
394931|NCT00474539|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
423034|NCT00535002|E2|Reported Event|Cocaine Males|Cocaine-dependent males
394934|NCT00474539|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
394935|NCT00474539|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
394804|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394805|NCT00474526|O1|Outcome|US1 (Men ACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
394806|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394807|NCT00474526|O1|Outcome|US1 (Men ACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
394808|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
394809|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
394810|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
394811|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
394812|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394813|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
394814|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394815|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
394816|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
394817|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
394818|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394819|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and received,as part of routine infant vaccination schedule, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group US1 was randomized into subgroups US1A and US1B.
394820|NCT00474526|O4|Outcome|LA4+LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:
One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).
Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
394821|NCT00474526|O3|Outcome|LA3+LA5 (Men ACWY-CRM + Infant Vaccines)|"Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:
Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)
Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).
Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
394870|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
394822|NCT00474526|O2|Outcome|US2+US4 (Infant Vaccines Only)|Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
394823|NCT00474526|O1|Outcome|US1+US3 (Men ACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
394824|NCT00474526|O4|Outcome|LA4+LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:
One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).
Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
394825|NCT00474526|O3|Outcome|LA3+LA5 (Men ACWY-CRM + Infant Vaccines)|"LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:
Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)
Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).
Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
394826|NCT00474526|O2|Outcome|US2+US4 (Infant Vaccines Only)|Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
394827|NCT00474526|O1|Outcome|US1+US3 (Men ACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
394828|NCT00474526|O4|Outcome|LA4 + LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.
LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:
One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).
Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
394829|NCT00474526|O3|Outcome|LA3 + LA5 (Men ACWY-CRM + Infant Vaccines)|"Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled.
LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:
Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)
Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).
Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
394830|NCT00474526|O2|Outcome|US2 + US4 (Infant Vaccines Only)|"Groups Infant Vaccines only (US2+US4) pooled
US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:
either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A); or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and one dose at 15 months of age (US4B); or one dose of MenACWY at 18 months of age (US4C)."
394831|NCT00474526|O1|Outcome|US1 + US3 (Men ACWY-CRM + Infant Vaccines)|"Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled.
US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B)."
394832|NCT00474526|O4|Outcome|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
394833|NCT00474526|O3|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394834|NCT00474526|O2|Outcome|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
394835|NCT00474526|O1|Outcome|US2 + US4A (Infant Vaccines Only)|Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394836|NCT00474526|O13|Outcome|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
394837|NCT00474526|O12|Outcome|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
394838|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
394839|NCT00474526|O10|Outcome|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
394840|NCT00474526|O9|Outcome|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
394841|NCT00474526|O8|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394842|NCT00474526|O7|Outcome|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
394843|NCT00474526|O6|Outcome|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394844|NCT00474526|O5|Outcome|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
394845|NCT00474526|O4|Outcome|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
394846|NCT00474526|O3|Outcome|US2 + US4A (Infant Vaccines Only)|Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394847|NCT00474526|O2|Outcome|US1A + US3 (MenACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled.In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
394848|NCT00474526|O1|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
394849|NCT00474526|O11|Outcome|LA6B + LA6C (Infant Vaccines Only)|"Groups Infant Vaccines only LA6B and LA6C pooled.
Infant Vaccines only (LA6B): LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
394850|NCT00474526|O10|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
394871|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
394851|NCT00474526|O9|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394852|NCT00474526|O8|Outcome|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
394853|NCT00474526|O7|Outcome|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394854|NCT00474526|O6|Outcome|US4B + US4C (Infant Vaccines Only)|"Groups Infant Vaccines only (US4B and US4C) pooled.
Infant Vaccines only (US4B): US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either received one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B); or one dose at 18 months of age (US4C)."
394855|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394856|NCT00474526|O4|Outcome|US2 + US4A (Infant Vaccines Only)|"Groups Infant Vaccines only (US2 and US4A) pooled.
In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age."
394857|NCT00474526|O3|Outcome|US1A + US3 (MenACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled. In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
394858|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
394859|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
394860|NCT00474526|O12|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
394861|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
394862|NCT00474526|O10|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394863|NCT00474526|O9|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
394864|NCT00474526|O8|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394865|NCT00474526|O7|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
394866|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
394867|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394868|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394869|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
394872|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394873|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
394874|NCT00474526|O10|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
394875|NCT00474526|O9|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
394876|NCT00474526|O8|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394877|NCT00474526|O7|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
394878|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
394879|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394880|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394881|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
394882|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
394883|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
394884|NCT00474526|O12|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
394885|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
394886|NCT00474526|O10|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
394887|NCT00474526|O9|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
394888|NCT00474526|O8|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394889|NCT00474526|O7|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
394890|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only )|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
394891|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
394892|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
394893|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
394894|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines )|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
394895|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
394896|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
394897|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
394898|NCT00474526|E6|Reported Event|LA6C|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
394899|NCT00474526|E5|Reported Event|LA2+4+6AB|Groups Infant Vaccines only (LA2, LA4, LA6A and LA6B) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants either received: one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY at 15 months of age (LA2 and LA4) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B).
394900|NCT00474526|E4|Reported Event|LA1+LA3+LA5|"Groups Men ACWY-CRM + Infant Vaccines (LA1, LA3 and LA5) pooled
LA infants received MenACWY at 2 and 6 months of age; and DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received at 12 months of age pneumococcal conjugate vaccine, HAV, and MMR-V and concomitant third dose of MenACWY (LA1A) or a third dose of MenACWY at 13 months of age (LA1B).
LA infants received MenACWY, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. At 12 months of age these infants received pneumococcal conjugate vaccine, HAV, and MMR-V and received:
Fourth dose of MenACWY concomitantly with DTaP and Hib at 16 months of age (LA3A)
DTaP and Hib at 16 months and fourth dose of MenACWY at 17 months of age (LA3B).
Concomitantly the fourth dose of MenACWY (LA5)."
394901|NCT00474526|E3|Reported Event|US4C|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
394902|NCT00474526|E2|Reported Event|US2+US4A+US4B|"Groups Infant Vaccines only (US2, US4A, and US4B) pooled.
In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:
One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age ( US2 and US4A).
Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B)"
394903|NCT00474526|E1|Reported Event|US1+US3|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
394904|NCT00474539|B3|Baseline|Total|Total of all reporting groups
394905|NCT00474539|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
394906|NCT00474539|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
394932|NCT00474539|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
394907|NCT00474539|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
394908|NCT00474539|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
394909|NCT00474539|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
394910|NCT00474539|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
394911|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
394912|NCT00474539|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
394913|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
394914|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
394915|NCT00474539|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
394916|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
394917|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|SParticipants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
394918|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
394919|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
394920|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
394921|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
394922|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
394923|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
394924|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
394925|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
394926|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
394927|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2)
394928|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
394936|NCT00474539|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
394937|NCT00474539|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
394938|NCT00474539|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
394939|NCT00474539|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
394940|NCT00474539|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
394941|NCT00474539|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
394942|NCT00474539|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
394943|NCT00474539|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
394944|NCT00474539|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
394945|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
394946|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
394947|NCT00474539|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
394948|NCT00474539|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
394949|NCT00474539|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
394950|NCT00474539|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
394951|NCT00474539|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
394952|NCT00474539|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
394953|NCT00474539|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
394954|NCT00474539|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
394955|NCT00474630|B3|Baseline|Total|Total of all reporting groups
394956|NCT00474630|B2|Baseline|Placebo|Placebo
394957|NCT00474630|B1|Baseline|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394958|NCT00474630|P2|Participant Flow|Placebo|Placebo
394959|NCT00474630|P1|Participant Flow|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394960|NCT00474630|O2|Outcome|Placebo|Placebo
394961|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394962|NCT00474630|O2|Outcome|Placebo|Placebo
394963|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394964|NCT00474630|O2|Outcome|Placebo|Placebo
394965|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394966|NCT00474630|O2|Outcome|Placebo|Placebo
394967|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394968|NCT00474630|O2|Outcome|Placebo|Placebo
394969|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394970|NCT00474630|O2|Outcome|Placebo|Placebo
394971|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394972|NCT00474630|O2|Outcome|Placebo|Placebo
394973|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394974|NCT00474630|O2|Outcome|Placebo|Placebo
394975|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394976|NCT00474630|O2|Outcome|Placebo|Placebo
394977|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394978|NCT00474630|O2|Outcome|Placebo|Placebo
394979|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394985|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394986|NCT00474630|O2|Outcome|Placebo|Placebo
394987|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394988|NCT00474630|O2|Outcome|Placebo|Placebo
394993|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394994|NCT00474630|O2|Outcome|Placebo|Placebo
394995|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394996|NCT00474630|O2|Outcome|Placebo|Placebo
394997|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
394998|NCT00474630|O2|Outcome|Placebo|Placebo
394999|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
395000|NCT00474630|O2|Outcome|Placebo|Placebo
395001|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
395002|NCT00474630|O2|Outcome|Placebo|Placebo
395003|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
395004|NCT00474630|O2|Outcome|Placebo|Placebo
395005|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
395006|NCT00474630|O2|Outcome|Placebo|Placebo
395007|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/ day
395008|NCT00474630|O2|Outcome|Placebo|Placebo
395009|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
395010|NCT00474630|E2|Reported Event|Placebo|Placebo
395011|NCT00474630|E1|Reported Event|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg daily
395012|NCT00474708|B3|Baseline|Total|Total of all reporting groups
395013|NCT00474708|B2|Baseline|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
395014|NCT00474708|B1|Baseline|Venlafaxine XR|75-225 mg per day
395015|NCT00474708|P2|Participant Flow|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
395016|NCT00474708|P1|Participant Flow|Venlafaxine XR|75-225 mg per day
395017|NCT00474708|O2|Outcome|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
395018|NCT00474708|O1|Outcome|Venlafaxine XR|75-225 mg per day
395019|NCT00474708|O2|Outcome|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
395020|NCT00474708|O1|Outcome|Venlafaxine XR|75-225 mg per day
395021|NCT00474708|E2|Reported Event|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
395022|NCT00474708|E1|Reported Event|Venlafaxine XR|75-225 mg per day
395023|NCT00474760|B8|Baseline|Total|Total of all reporting groups
395024|NCT00474760|B7|Baseline|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395025|NCT00474760|B6|Baseline|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
395026|NCT00474760|B5|Baseline|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
395027|NCT00474760|B4|Baseline|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395028|NCT00474760|B3|Baseline|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395029|NCT00474760|B2|Baseline|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395030|NCT00474760|B1|Baseline|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395031|NCT00474760|P7|Participant Flow|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D Ewing’s sarcoma family of tumors [ESFT] extension cohort.
395032|NCT00474760|P6|Participant Flow|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D adrenocortical carcinoma [ACC] and sarcoma extension cohort.
395033|NCT00474760|P5|Participant Flow|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for recommended Phase 2 dose [RP2D] extension cohort.
395034|NCT00474760|P4|Participant Flow|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395169|NCT00474812|E1|Reported Event|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
395170|NCT00474851|B3|Baseline|Total|Total of all reporting groups
395035|NCT00474760|P3|Participant Flow|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395036|NCT00474760|P2|Participant Flow|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395171|NCT00474851|B2|Baseline|Placebo Group|"Placebo: Placebo capsule 1 pill PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
395037|NCT00474760|P1|Participant Flow|Figitumumab 3 mg/kg|Figitumumab 3 milligram/kilogram (mg/kg) was supplied as a liquid solution administered as an intravenous (IV) infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395038|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.
395039|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.
395040|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration for dose escalation, RP2D extension, and RP2D ACC and sarcoma extension cohorts, 4 weeks in duration for RP2D ESFT extension cohort).
395041|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395042|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395043|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395044|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395045|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395046|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395047|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395048|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395049|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395050|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395051|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395052|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395053|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395054|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395055|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395056|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395057|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395058|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395059|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395060|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395205|NCT00474929|P3|Participant Flow|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
395061|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395062|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395063|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395064|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395065|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395066|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395067|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395068|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395069|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395070|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395071|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395072|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395073|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395074|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395075|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395076|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395077|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395078|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395079|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395080|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395081|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395082|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395083|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395084|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395085|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395086|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395087|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
423444|NCT00536107|O1|Outcome|Gefitinib|gefitinib 250mg
395088|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395172|NCT00474851|B1|Baseline|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
395089|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395090|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395091|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395092|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395093|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395094|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395095|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395096|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395097|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395098|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395099|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395100|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395101|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395102|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395103|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395104|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395105|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395106|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395107|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395108|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395109|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395110|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395111|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395112|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395113|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395114|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395115|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395116|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395117|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395118|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395119|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395120|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395121|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395122|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
395123|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395124|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395125|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395126|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395127|NCT00474760|O7|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395128|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
395129|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
395130|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395131|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395132|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395133|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395134|NCT00474760|E7|Reported Event|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
395135|NCT00474760|E6|Reported Event|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
395136|NCT00474760|E5|Reported Event|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
395137|NCT00474760|E4|Reported Event|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395138|NCT00474760|E3|Reported Event|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395139|NCT00474760|E2|Reported Event|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395140|NCT00474760|E1|Reported Event|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
395141|NCT00474786|B3|Baseline|Total|Total of all reporting groups
395142|NCT00474786|B2|Baseline|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395173|NCT00474851|P2|Participant Flow|Placebo Group|"Placebo group
Placebo: Placebo capsule 1 pill PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
395240|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
395143|NCT00474786|B1|Baseline|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395144|NCT00474786|P2|Participant Flow|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395145|NCT00474786|P1|Participant Flow|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395146|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395147|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395148|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395149|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395150|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395151|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395152|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395153|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395154|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395155|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395156|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395157|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395158|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395159|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395160|NCT00474786|E2|Reported Event|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395161|NCT00474786|E1|Reported Event|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
395162|NCT00474812|B1|Baseline|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
395163|NCT00474812|P1|Participant Flow|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
395164|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
395165|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
395166|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
395167|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
395168|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
395174|NCT00474851|P1|Participant Flow|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
395175|NCT00474851|O2|Outcome|Placebo Group|"Placebo: Placebo capsule 1 pill PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
395176|NCT00474851|O1|Outcome|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
395177|NCT00474851|O2|Outcome|Placebo Group|"Placebo group
Placebo: Placebo capsule 1 pill PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
395178|NCT00474851|O1|Outcome|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
395179|NCT00474851|E2|Reported Event|Placebo Group|"Placebo group
Placebo: Placebo capsule 1 pill PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
395180|NCT00474851|E1|Reported Event|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
395181|NCT00474903|B4|Baseline|Total|Total of all reporting groups
395182|NCT00474903|B3|Baseline|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
395183|NCT00474903|B2|Baseline|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
395184|NCT00474903|B1|Baseline|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally"
395185|NCT00474903|P3|Participant Flow|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
395186|NCT00474903|P2|Participant Flow|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
395187|NCT00474903|P1|Participant Flow|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally"
395188|NCT00474903|O3|Outcome|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
395189|NCT00474903|O2|Outcome|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
395190|NCT00474903|O1|Outcome|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally"
395191|NCT00474903|O3|Outcome|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
395192|NCT00474903|O2|Outcome|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
395193|NCT00474903|O1|Outcome|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally"
395194|NCT00474903|E3|Reported Event|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
395195|NCT00474903|E2|Reported Event|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
395196|NCT00474903|E1|Reported Event|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally"
395197|NCT00474929|B6|Baseline|Total|Total of all reporting groups
395198|NCT00474929|B5|Baseline|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
395199|NCT00474929|B4|Baseline|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
395200|NCT00474929|B3|Baseline|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
395201|NCT00474929|B2|Baseline|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
395202|NCT00474929|B1|Baseline|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day;
395203|NCT00474929|P5|Participant Flow|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
395204|NCT00474929|P4|Participant Flow|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
395206|NCT00474929|P2|Participant Flow|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
395207|NCT00474929|P1|Participant Flow|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
395239|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
448773|NCT00600015|O2|Outcome|Placebo|Erlotinib + Placebo
395208|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). This includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).
395209|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). This includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).
395210|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|"This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). Due to concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2, the PI felt it was in the best interest of the patients to choose dose level 1 as the MTD and the dose level for Phase II.
Therefore, the analysis of the Phase II endpoint includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77)."
395211|NCT00474929|O4|Outcome|Phase I, Dose Level 3|Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
395212|NCT00474929|O3|Outcome|Phase I, Dose Level 2|Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
395213|NCT00474929|O2|Outcome|Phase I, Dose Level 1|Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
395214|NCT00474929|O1|Outcome|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
395215|NCT00474929|E5|Reported Event|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
395216|NCT00474929|E4|Reported Event|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
395217|NCT00474929|E3|Reported Event|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
395218|NCT00474929|E2|Reported Event|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
395219|NCT00474929|E1|Reported Event|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
395220|NCT00474955|B1|Baseline|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
395221|NCT00474955|P1|Participant Flow|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a [Pegasys] [40 kilo Dalton (kDa)], 180 micrograms (mcg) as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate (GFR) of <15 milliliter (mL)/minute (min) were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
395222|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
395223|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
395224|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
395225|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
395226|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
395227|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
395228|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
395229|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
395230|NCT00474955|E1|Reported Event|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
395231|NCT00474968|B3|Baseline|Total|Total of all reporting groups
395232|NCT00474968|B2|Baseline|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
395233|NCT00474968|B1|Baseline|SoftPAP|Samples collected using the SoftPAP Collector
395234|NCT00474968|P2|Participant Flow|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
395235|NCT00474968|P1|Participant Flow|SoftPAP|Samples collected using the SoftPAP Collector
395236|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
395237|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
395238|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
395241|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
395242|NCT00474968|E2|Reported Event|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
395243|NCT00474968|E1|Reported Event|SoftPAP|Samples collected using the SoftPAP Collector
395244|NCT00474994|B1|Baseline|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
395245|NCT00474994|P1|Participant Flow|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
395246|NCT00474994|O1|Outcome|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
395247|NCT00474994|E1|Reported Event|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
395248|NCT00475033|B3|Baseline|Total|Total of all reporting groups
395249|NCT00475033|B2|Baseline|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395250|NCT00475033|B1|Baseline|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395251|NCT00475033|P2|Participant Flow|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395252|NCT00475033|P1|Participant Flow|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395253|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395254|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395255|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395256|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
423445|NCT00536107|E2|Reported Event|Docetaxel|docetaxel 60mg/m sq
395302|NCT00475085|B2|Baseline|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
placebo : Given orally
aprepitant : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395362|NCT00475306|B2|Baseline|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
448774|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
395257|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395258|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395259|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395260|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395261|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395262|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395263|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395264|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395265|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395266|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395324|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
423446|NCT00536107|E1|Reported Event|Gefitinib|gefitinib 250mg
395267|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395268|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395269|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395270|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395271|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395272|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395273|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395274|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395275|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395276|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395325|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395277|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395278|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395279|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395280|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395281|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395282|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395283|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395284|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395285|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395286|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395326|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395287|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395288|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395289|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395290|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395291|NCT00475033|E8|Reported Event|7vPnC Toddler Dose 6-Month Follow-up|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395292|NCT00475033|E7|Reported Event|13vPnC Toddler Dose 6-Month Follow-up|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
395293|NCT00475033|E6|Reported Event|7vPnC Toddler Dose|"Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=108; systematic (solicited) Any Local Reactions N=86; systematic (solicited) Any Systemic Events N=193."
395294|NCT00475033|E5|Reported Event|13vPnC Toddler Dose|"Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=110; systematic (solicited) Any Local Reactions N=84; systematic (solicited) Any Systemic Events N=199."
395295|NCT00475033|E4|Reported Event|7vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
395296|NCT00475033|E3|Reported Event|13vPnC After the Infant Series|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
395297|NCT00475033|E2|Reported Event|7vPnC Infant Series|"Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=230; systematic (solicited) Any Local Reactions N=148; systematic (solicited) Any Systemic Events N=279."
395298|NCT00475033|E1|Reported Event|13vPnC Infant Series|"Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=229; systematic (solicited) Any Local Reactions N=144; systematic (solicited) Any Systemic Events N=273."
395299|NCT00475085|B5|Baseline|Total|Total of all reporting groups
395300|NCT00475085|B4|Baseline|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395301|NCT00475085|B3|Baseline|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395303|NCT00475085|B1|Baseline|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
granisetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395304|NCT00475085|P4|Participant Flow|Arm 4 Palonosetron, Dexamethasone, Compazine, Dexamethasone|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395305|NCT00475085|P3|Participant Flow|Arm 3 Aprepitant, Palonosetron, Dexamethasone|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
placebo : Given orally
aprepitant : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395306|NCT00475085|P2|Participant Flow|Arm 2 Granisetron, Dexamethasone, Compazine|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
granisetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395307|NCT00475085|P1|Participant Flow|Arm 1 Palonosetron, Dexamethasone, Compazine|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395308|NCT00475085|O4|Outcome|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395309|NCT00475085|O3|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395310|NCT00475085|O2|Outcome|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
placebo : Given orally
aprepitant : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395311|NCT00475085|O1|Outcome|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
granisetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395312|NCT00475085|E4|Reported Event|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395313|NCT00475085|E3|Reported Event|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395314|NCT00475085|E2|Reported Event|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
placebo : Given orally
aprepitant : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395315|NCT00475085|E1|Reported Event|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
granisetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV"
395316|NCT00475150|B3|Baseline|Total|Total of all reporting groups
395317|NCT00475150|B2|Baseline|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395318|NCT00475150|B1|Baseline|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395319|NCT00475150|P2|Participant Flow|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395320|NCT00475150|P1|Participant Flow|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395321|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395322|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395323|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395358|NCT00475241|E1|Reported Event|Prolonged Exposure|"Prolonged exposure therapy for PTSD
Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
395327|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395361|NCT00475306|B3|Baseline|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
395328|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395329|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395330|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
395331|NCT00475150|E1|Reported Event|All Patients Receiving Cediranib Maleate|All patients receiving oral cediranib maleate, regardless of diagnosis were analyzed for toxicity.
395332|NCT00475176|B1|Baseline|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
395333|NCT00475176|P1|Participant Flow|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin. After screening evaluation, patients will receive a first course of 2 weeks of peginterferon alfa-2a (180 micrograms weekly) and ribavirin (1000-1200 mg daily) during which symptoms, routine laboratory tests, HCV RNA levels, natural killer (NK) cell activity, and lymphocyte interferon-signaling responses will be monitored. After a 4-week washout period, patients will start SAMe (800 mg twice daily) for 2 weeks and then begin a second course of peginterferon and ribavirin in the same doses with similar monitoring. Therapy will be continued for at least 12 weeks, and patients with an early viral response will continue for a full 48 weeks.
395334|NCT00475176|O1|Outcome|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
395335|NCT00475176|O1|Outcome|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
395336|NCT00475176|E1|Reported Event|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
395337|NCT00475228|B3|Baseline|Total|Total of all reporting groups
395338|NCT00475228|B2|Baseline|Arm 2: Delayed LNG-IUD Insertion Group|Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice.
395339|NCT00475228|B1|Baseline|Arm I: Immediate LNG-IUD Insertion Group|Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D& E
395340|NCT00475228|P2|Participant Flow|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)
Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
395341|NCT00475228|P1|Participant Flow|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted immediately after completion of D&E
Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
395342|NCT00475228|O2|Outcome|Arm 2: Delayed LNG-IUD Insertion Group|Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice.
395343|NCT00475228|O1|Outcome|Arm I: Immediate LNG-IUD Insertion Group|Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D& E
395344|NCT00475228|O2|Outcome|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD was inserted immediately after completion of D&E in all 44 participants
Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
395345|NCT00475228|O1|Outcome|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD was inserted at standard time post-procedure (3-6 weeks post D&E procedure) in 20 participants. The remaining 24 women did not return 3-6 weeks after the D&E.
Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
395346|NCT00475228|O2|Outcome|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)
Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
395347|NCT00475228|O1|Outcome|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted immediately after completion of D&E
Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
395348|NCT00475228|E2|Reported Event|Arm 2|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)
Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
395349|NCT00475228|E1|Reported Event|Arm I|"Levonorgestrel IUD will be inserted immediately after completion of D&E
Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
395350|NCT00475241|B3|Baseline|Total|Total of all reporting groups
395351|NCT00475241|B2|Baseline|Present Centered Therapy|"Present centered therapy for PTSD
Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
395352|NCT00475241|B1|Baseline|Prolonged Exposure|"Prolonged exposure therapy for PTSD
Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
395353|NCT00475241|P2|Participant Flow|Present Centered Therapy|"Present centered therapy for PTSD
Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
395354|NCT00475241|P1|Participant Flow|Prolonged Exposure|"Prolonged exposure therapy for PTSD
Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
395355|NCT00475241|O2|Outcome|Present Centered Therapy|"Present centered therapy for PTSD
Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
395356|NCT00475241|O1|Outcome|Prolonged Exposure|"Prolonged exposure therapy for PTSD
Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
395357|NCT00475241|E2|Reported Event|Present Centered Therapy|"Present centered therapy for PTSD
Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
395360|NCT00475306|B4|Baseline|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
395771|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395363|NCT00475306|B1|Baseline|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
395364|NCT00475306|P4|Participant Flow|Metoclopramide 10+Diphenhydramine|Metoclopramide 10 mg co-administered with diphenhydramine 25 mg, intravenously
395365|NCT00475306|P3|Participant Flow|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
395366|NCT00475306|P2|Participant Flow|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
395367|NCT00475306|P1|Participant Flow|Metoclopramide 20 mg+Diphenhydramine|Metoclopramide 20mg co-administered with diphenhydramine 25 mg, intravenously
395368|NCT00475306|O4|Outcome|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
395369|NCT00475306|O3|Outcome|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
395370|NCT00475306|O2|Outcome|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
395371|NCT00475306|O1|Outcome|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
395372|NCT00475306|O4|Outcome|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
395373|NCT00475306|O3|Outcome|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
395374|NCT00475306|O2|Outcome|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
395375|NCT00475306|O1|Outcome|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
395376|NCT00475306|E4|Reported Event|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
395377|NCT00475306|E3|Reported Event|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
395378|NCT00475306|E2|Reported Event|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
395379|NCT00475306|E1|Reported Event|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
395380|NCT00475319|B4|Baseline|Total|Total of all reporting groups
395381|NCT00475319|B3|Baseline|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395382|NCT00475319|B2|Baseline|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395383|NCT00475319|B1|Baseline|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395384|NCT00475319|P3|Participant Flow|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395385|NCT00475319|P2|Participant Flow|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395386|NCT00475319|P1|Participant Flow|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395387|NCT00475319|O3|Outcome|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395388|NCT00475319|O2|Outcome|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395389|NCT00475319|O1|Outcome|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395390|NCT00475319|O3|Outcome|Placebo|0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
395391|NCT00475319|O2|Outcome|2% OPC-12759 Ophthalmic Suspension|2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
395392|NCT00475319|O1|Outcome|1% OPC-12759 Ophthalmic Suspension|1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
395393|NCT00475319|E3|Reported Event|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395394|NCT00475319|E2|Reported Event|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395395|NCT00475319|E1|Reported Event|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
395396|NCT00475332|B1|Baseline|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
395397|NCT00475332|P1|Participant Flow|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
395398|NCT00475332|O1|Outcome|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
395399|NCT00475332|O1|Outcome|Radiation Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
395400|NCT00475332|E1|Reported Event|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
395401|NCT00475423|B1|Baseline|Rituximab|Participants received rituximab 1000 mg IV on Days 1 and 15.
395402|NCT00475423|P1|Participant Flow|Rituximab|Participants received rituximab 1000 milligrams (mg) intravenously (IV) on Days 1 and 15.
395403|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395404|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395405|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395406|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395407|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
423447|NCT00536120|B3|Baseline|Total|Total of all reporting groups
395408|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395409|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395410|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395411|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395412|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395413|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395414|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395415|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395416|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395417|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395418|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395419|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395420|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395421|NCT00475423|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
395422|NCT00475501|B5|Baseline|Total|Total of all reporting groups
395423|NCT00475501|B4|Baseline|Vehicle Placebo|weekly vehicle injection daily placebo pill
395424|NCT00475501|B3|Baseline|Testosterone Finasteride|125 mg testosterone enanthate/week i.m. 5 mg finasteride/day p.o.
395425|NCT00475501|B2|Baseline|Vehicle Finasteride|weekly vehicle injection 5 mg finasteride/day p.o.
395426|NCT00475501|B1|Baseline|Testosterone Vehicle|125 mg testosterone enanthate/week i.m. daily placebo pill
395427|NCT00475501|P4|Participant Flow|Arm 4|"placebo
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395428|NCT00475501|P3|Participant Flow|Arm 3|"testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395429|NCT00475501|P2|Participant Flow|Arm 2|"finasteride
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.
Finasteride : 5 mg, oral, once/day, for 52 weeks"
395430|NCT00475501|P1|Participant Flow|Arm 1|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395431|NCT00475501|O4|Outcome|Arm 4|"placebo
Life Satisfaction A"
395432|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Life Satisfaction A"
395433|NCT00475501|O2|Outcome|Arm 2|"finasteride
Finasteride : 5 mg, oral, once/day, for 52 weeks
Life Satisfaction A"
395434|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Life Satisfaction A"
395435|NCT00475501|O4|Outcome|Arm 4|"placebo
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395436|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395437|NCT00475501|O2|Outcome|Arm 2|"finasteride
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.
Finasteride : 5 mg, oral, once/day, for 52 weeks"
395438|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395439|NCT00475501|O4|Outcome|Arm 4|"placebo
Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
395440|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
395441|NCT00475501|O2|Outcome|Arm 2|"finasteride
Finasteride : 5 mg, oral, once/day, for 52 weeks
Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
395442|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
395443|NCT00475501|O4|Outcome|Arm 4|"placebo
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395479|NCT00475657|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
395480|NCT00475657|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
395481|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
395525|NCT00475722|O2|Outcome|2 Mediterranean|"Mediterranean Diet
Mediterranean Diet through dietary counseling: 6 months telephone counseling"
395444|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395445|NCT00475501|O2|Outcome|Arm 2|"finasteride
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.
Finasteride : 5 mg, oral, once/day, for 52 weeks"
395446|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395447|NCT00475501|O4|Outcome|Arm 4|"placebo
Benton Test -Judgment of Line Orientation"
395448|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Benton Test -Judgment of Line Orientation"
395449|NCT00475501|O2|Outcome|Arm 2|"finasteride
Benton Test -Judgment of Line Orientation
Finasteride : 5 mg, oral, once/day, for 52 weeks"
395450|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Benton Test -Judgment of Line Orientation"
395451|NCT00475501|O4|Outcome|Arm 4|"placebo
Trail Making Test A"
395452|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Trail Making Test A"
395453|NCT00475501|O2|Outcome|Arm 2|"finasteride
Trail Making Test A Finasteride : 5 mg, oral, once/day, for 52 weeks"
395454|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Trail Making Test A"
395455|NCT00475501|O4|Outcome|Arm 4|"placebo
30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
395456|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
395457|NCT00475501|O2|Outcome|Arm 2|"finasteride
30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test Finasteride : 5 mg, oral, once/day, for 52 weeks"
395458|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
395459|NCT00475501|O4|Outcome|Vehicle Placebo|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
395460|NCT00475501|O3|Outcome|Testosterone Finasteride|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
395461|NCT00475501|O2|Outcome|Vehicle Finasteride|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
395462|NCT00475501|O1|Outcome|Testosterone Vehicle|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
395463|NCT00475501|O4|Outcome|Arm 4|"placebo
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395464|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395465|NCT00475501|O2|Outcome|Arm 2|"finasteride
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.
Finasteride : 5 mg, oral, once/day, for 52 weeks"
395466|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
395467|NCT00475501|O4|Outcome|Vehicle Placebo|grip strength measure on a dynamometer
395468|NCT00475501|O3|Outcome|Testosterone Finasteride|grip strength measure on a dynamometer
395469|NCT00475501|O2|Outcome|Vehicle Finasteride|grip strength measure on a dynamometer
395470|NCT00475501|O1|Outcome|Testosterone Vehicle|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
grip strength measure on a dynamometer"
395471|NCT00475501|O4|Outcome|Arm 4|"placebo
Measurement of leg press strength, 1-RM"
395472|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM"
395473|NCT00475501|O2|Outcome|Arm 2|"finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks"
395474|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM"
395475|NCT00475501|E4|Reported Event|Arm 4|placebo
395476|NCT00475501|E3|Reported Event|Arm 3|"testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks"
395477|NCT00475501|E2|Reported Event|Arm 2|"finasteride
Finasteride : 5 mg, oral, once/day, for 52 weeks"
395478|NCT00475501|E1|Reported Event|Arm 1|"testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks"
395482|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
395483|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
395484|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
395485|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
395486|NCT00475657|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
395487|NCT00475670|B3|Baseline|Total|Total of all reporting groups
395488|NCT00475670|B2|Baseline|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395489|NCT00475670|B1|Baseline|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395490|NCT00475670|P2|Participant Flow|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/square meter (m^2), IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395491|NCT00475670|P1|Participant Flow|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395492|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395493|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395494|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395495|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395496|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395497|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395498|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395499|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395521|NCT00475722|B2|Baseline|2 Mediterranean|"Mediterranean Diet using an exchange list
2 Mediterranean: 6 months telephone counseling"
395522|NCT00475722|B1|Baseline|1 Healthy Eating|"Healthy People 2010 Diet using an exchange list
1 Healthy Eating: 6 months telephone counseling"
395523|NCT00475722|P2|Participant Flow|2 Mediterranean|"Mediterranean Diet
Mediterranean Diet through dietary counseling: 6 months telephone counseling"
423846|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
395524|NCT00475722|P1|Participant Flow|1 Healthy Eating|"Healthy People 2010 Diet
Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
395500|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395501|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395502|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395503|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395504|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395505|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395506|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395507|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395508|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395509|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395510|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395511|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395512|NCT00475670|E2|Reported Event|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
395513|NCT00475670|E1|Reported Event|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
395514|NCT00475709|B1|Baseline|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
395515|NCT00475709|P1|Participant Flow|Subjects Implanted With Trifecta Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
395516|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
395517|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
395518|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
395519|NCT00475709|E1|Reported Event|Subjects Implanted With Trifecta Valve|
395520|NCT00475722|B3|Baseline|Total|Total of all reporting groups
395526|NCT00475722|O1|Outcome|1 Healthy Eating|"Healthy People 2010 Diet
Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
395527|NCT00475722|E2|Reported Event|2 Mediterranean|"Mediterranean Diet
Mediterranean Diet through dietary counseling: 6 months telephone counseling"
395528|NCT00475722|E1|Reported Event|1 Healthy Eating|"Healthy People 2010 Diet
Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
395529|NCT00475735|B7|Baseline|Total|Total of all reporting groups
395530|NCT00475735|B6|Baseline|Placebo Then Concerta|These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
395531|NCT00475735|B5|Baseline|Concerta Then Placebo|These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
395532|NCT00475735|B4|Baseline|Concerta Then MK-0249|These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
395533|NCT00475735|B3|Baseline|MK-0249 Then Concerta|These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
395534|NCT00475735|B2|Baseline|Placebo Then MK-0249|These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
395535|NCT00475735|B1|Baseline|MK-0249 Then Placebo|These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
395536|NCT00475735|P6|Participant Flow|Placebo Then Concerta|These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
395537|NCT00475735|P5|Participant Flow|Concerta Then Placebo|These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
395538|NCT00475735|P4|Participant Flow|Concerta Then MK-0249|These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
395539|NCT00475735|P3|Participant Flow|MK-0249 Then Concerta|These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
395540|NCT00475735|P2|Participant Flow|Placebo Then MK-0249|These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
395541|NCT00475735|P1|Participant Flow|MK-0249 Then Placebo|These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
395542|NCT00475735|O3|Outcome|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
395543|NCT00475735|O2|Outcome|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
395544|NCT00475735|O1|Outcome|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
395545|NCT00475735|O3|Outcome|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
395546|NCT00475735|O2|Outcome|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
395547|NCT00475735|O1|Outcome|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
395548|NCT00475735|E3|Reported Event|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
395549|NCT00475735|E2|Reported Event|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
395550|NCT00475735|E1|Reported Event|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
395551|NCT00475787|B3|Baseline|Total|Total of all reporting groups
395552|NCT00475787|B2|Baseline|Arm 2|"Detuned Ultrasound
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395553|NCT00475787|B1|Baseline|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395554|NCT00475787|P2|Participant Flow|Arm 2|"Detuned Ultrasound
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395555|NCT00475787|P1|Participant Flow|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395556|NCT00475787|O2|Outcome|Sham Group|"Detuned Ultrasound
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
396446|NCT00467753|B2|Baseline|Sugar Pill|Placebo : Dosage similar to active drug
395557|NCT00475787|O1|Outcome|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395558|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395559|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395560|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395561|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395562|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395563|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395564|NCT00475787|O2|Outcome|Sham Group|"Detuned Ultrasound
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395565|NCT00475787|O1|Outcome|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395566|NCT00475787|E2|Reported Event|Sham Intervention|Detuned Ultrasound
395567|NCT00475787|E1|Reported Event|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
395568|NCT00475852|B3|Baseline|Total|Total of all reporting groups
395569|NCT00475852|B2|Baseline|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395570|NCT00475852|B1|Baseline|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395571|NCT00475852|P2|Participant Flow|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395572|NCT00475852|P1|Participant Flow|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395573|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395574|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395575|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395576|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395577|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395578|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395579|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395580|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395581|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395582|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395583|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395584|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395585|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395586|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395587|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395588|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395589|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395590|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395591|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395592|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395593|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395594|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395595|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395596|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395597|NCT00475852|E2|Reported Event|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395598|NCT00475852|E1|Reported Event|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
395600|NCT00475865|B3|Baseline|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
397072|NCT00468585|O2|Outcome|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
395601|NCT00475865|B2|Baseline|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395602|NCT00475865|B1|Baseline|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395603|NCT00475865|P3|Participant Flow|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
395604|NCT00475865|P2|Participant Flow|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
395605|NCT00475865|P1|Participant Flow|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
395606|NCT00475865|O2|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395607|NCT00475865|O1|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395608|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395609|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395610|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395611|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395612|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395613|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395614|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395615|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395616|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395617|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395618|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395619|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395620|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395621|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395622|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395623|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395624|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395625|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395626|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395627|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395628|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395629|NCT00475865|E3|Reported Event|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395630|NCT00475865|E2|Reported Event|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395631|NCT00475865|E1|Reported Event|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
395632|NCT00475878|B3|Baseline|Total|Total of all reporting groups
395633|NCT00475878|B2|Baseline|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
395634|NCT00475878|B1|Baseline|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
395635|NCT00475878|P2|Participant Flow|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
395636|NCT00475878|P1|Participant Flow|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
395637|NCT00475878|O2|Outcome|Placebo|individuals were given a placebo study medication prior to buprenorphine induction
395638|NCT00475878|O1|Outcome|10 mg Escitalopram|individuals were given 10mg escitalopram prior to buprenorphine induction
395639|NCT00475878|O2|Outcome|Placebo|in a double-blind, randomized controlled trial, participants were given placebo prior to buprenorphine induction
395640|NCT00475878|O1|Outcome|10 mg Escitalopram|in a double-blind, randomized controlled trial, participants were given 10mg escitalopram prior to buprenorphine induction
395641|NCT00475878|E2|Reported Event|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
395642|NCT00475878|E1|Reported Event|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
395643|NCT00475904|B4|Baseline|Total|Total of all reporting groups
395644|NCT00475904|B3|Baseline|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
395645|NCT00475904|B2|Baseline|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
395646|NCT00475904|B1|Baseline|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
395647|NCT00475904|P3|Participant Flow|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
395648|NCT00475904|P2|Participant Flow|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
395649|NCT00475904|P1|Participant Flow|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
395650|NCT00475904|O3|Outcome|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
395651|NCT00475904|O2|Outcome|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
395652|NCT00475904|O1|Outcome|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
395653|NCT00475904|O3|Outcome|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
395654|NCT00475904|O2|Outcome|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
395655|NCT00475904|O1|Outcome|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
395656|NCT00475904|E3|Reported Event|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
395657|NCT00475904|E2|Reported Event|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
395658|NCT00475904|E1|Reported Event|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
395659|NCT00464711|B1|Baseline|Escitalopram|40 subjects met inclusion/exclusion criteria and started study treatment
395660|NCT00464711|P1|Participant Flow|Escitalopram|40 subjects met inclusion/exclusion criteria and started treatment with escitalopram
395661|NCT00464711|O1|Outcome|Open Label Escitalopram|All subjects were treated with open label escitalopram
395662|NCT00464711|E1|Reported Event|Escitalopram|40 subjects met inclusion/exclusion criteria and started study treatment
395663|NCT00464737|B4|Baseline|Total|Total of all reporting groups
395664|NCT00464737|B3|Baseline|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395665|NCT00464737|B2|Baseline|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395666|NCT00464737|B1|Baseline|Placebo|Placebo
395667|NCT00464737|P3|Participant Flow|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395668|NCT00464737|P2|Participant Flow|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395669|NCT00464737|P1|Participant Flow|Placebo|Placebo
395670|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395671|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395672|NCT00464737|O1|Outcome|Placebo|Placebo
395673|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395674|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395675|NCT00464737|O1|Outcome|Placebo|Placebo
395676|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395677|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395678|NCT00464737|O1|Outcome|Placebo|Placebo
395679|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395680|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395681|NCT00464737|O1|Outcome|Placebo|Placebo
395682|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395683|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395684|NCT00464737|O1|Outcome|Placebo|Placebo
395685|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395686|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395687|NCT00464737|O1|Outcome|Placebo|Placebo
395688|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395689|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395690|NCT00464737|O1|Outcome|Placebo|Placebo
395691|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395692|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395693|NCT00464737|O1|Outcome|Placebo|Placebo
395694|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395695|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395696|NCT00464737|O1|Outcome|Placebo|Placebo
395697|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395698|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395699|NCT00464737|O1|Outcome|Placebo|Placebo
395700|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395701|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395702|NCT00464737|O1|Outcome|Placebo|Placebo
395703|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395704|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395705|NCT00464737|O1|Outcome|Placebo|Placebo
395706|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395707|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395708|NCT00464737|O1|Outcome|Placebo|Placebo
395709|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395710|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395711|NCT00464737|O1|Outcome|Placebo|Placebo
395712|NCT00464737|E3|Reported Event|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
395713|NCT00464737|E2|Reported Event|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
395714|NCT00464737|E1|Reported Event|Placebo|Placebo
395715|NCT00464945|B3|Baseline|Total|Total of all reporting groups
396079|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
395770|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395716|NCT00464945|B2|Baseline|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395717|NCT00464945|B1|Baseline|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395718|NCT00464945|P2|Participant Flow|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395719|NCT00464945|P1|Participant Flow|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395720|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
395721|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
395722|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395723|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395724|NCT00464945|O6|Outcome|13vPnC Pilot Dose 3|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
395725|NCT00464945|O5|Outcome|13vPnC Manufacturing Dose 3|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
395726|NCT00464945|O4|Outcome|13vPnC Pilot Dose 2|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
395727|NCT00464945|O3|Outcome|13vPnC Manufacturing Dose 2|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
395728|NCT00464945|O2|Outcome|13vPnC Pilot Dose 1|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
395729|NCT00464945|O1|Outcome|13vPnC Manufacturing Dose 1|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
395730|NCT00464945|O8|Outcome|13vPnC Pilot Toddler Dose|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395731|NCT00464945|O7|Outcome|13vPnC Manufacturing Toddler Dose|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395732|NCT00464945|O6|Outcome|13vPnC Pilot Dose 3|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
395733|NCT00464945|O5|Outcome|13vPnC Manufacturing Dose 3|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
395734|NCT00464945|O4|Outcome|13vPnC Pilot Dose 2|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
395735|NCT00464945|O3|Outcome|13vPnC Manufacturing Dose 2|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
395736|NCT00464945|O2|Outcome|13vPnC Pilot Dose 1|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
395737|NCT00464945|O1|Outcome|13vPnC Manufacturing Dose 1|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
395738|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395739|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395740|NCT00464945|E6|Reported Event|13vPnC Pilot Toddler Series|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395741|NCT00464945|E5|Reported Event|13vPnC Manufacturing Toddler Series|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
395742|NCT00464945|E4|Reported Event|13vPnC Pilot Post-Infant Series|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.
395743|NCT00464945|E3|Reported Event|13vPnC Manufacturing Post-Infant Series|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.
395744|NCT00464945|E2|Reported Event|13vPnC Pilot Infant Series|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
395745|NCT00464945|E1|Reported Event|13vPnC Manufacturing Infant Series|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
395746|NCT00465088|B3|Baseline|Total|Total of all reporting groups
395747|NCT00465088|B2|Baseline|Atorvastatin|40 mg atorvastatin once daily at bedtime
395748|NCT00465088|B1|Baseline|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395749|NCT00465088|P2|Participant Flow|Atorvastatin|40 mg atorvastatin once daily at bedtime
395750|NCT00465088|P1|Participant Flow|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395751|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395752|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395753|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395754|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395755|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395756|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395757|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395758|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395759|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395760|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395761|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395762|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395763|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395764|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395765|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395766|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395767|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395768|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395769|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395772|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395773|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395774|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395775|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395776|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395777|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
395778|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395779|NCT00465088|E2|Reported Event|Atorvastatin|40 mg atorvastatin once daily at bedtime
395780|NCT00465088|E1|Reported Event|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
395781|NCT00465101|B1|Baseline|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
395782|NCT00465101|P1|Participant Flow|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
395783|NCT00465101|O1|Outcome|Retrograde Ejaculation Occurrence Rate|
395784|NCT00465101|O1|Outcome|Total Energy Delivered|
395785|NCT00465101|O1|Outcome|Number of Fibers Used|
395786|NCT00465101|O1|Outcome|Length of Lasing Time|
395787|NCT00465101|O1|Outcome|Length of Procedure (Min)|
395788|NCT00465101|O1|Outcome|Length of Catheterization|
395789|NCT00465101|O1|Outcome|Length of Hospital Stay (Hours)|
395790|NCT00465101|O1|Outcome|Return to Activity (Days)|
395791|NCT00465101|O8|Outcome|5 Years|
395792|NCT00465101|O7|Outcome|4 Years|
395793|NCT00465101|O6|Outcome|3 Year|
395794|NCT00465101|O5|Outcome|2 Years|
395795|NCT00465101|O4|Outcome|1 Year|
395796|NCT00465101|O3|Outcome|6 Months|
395797|NCT00465101|O2|Outcome|3 Months|
395798|NCT00465101|O1|Outcome|Baseline|
395799|NCT00465101|O2|Outcome|Delayed (15-91 Days)|
395800|NCT00465101|O1|Outcome|Peri-Operative (0-14 Days)|
395801|NCT00465101|O8|Outcome|5 Years|
395802|NCT00465101|O7|Outcome|4 Years|
395803|NCT00465101|O6|Outcome|3 Years|
395804|NCT00465101|O5|Outcome|2 Years|
395805|NCT00465101|O4|Outcome|1 Year|
395806|NCT00465101|O3|Outcome|6 Months|
395807|NCT00465101|O2|Outcome|3 Months|
395808|NCT00465101|O1|Outcome|Baseline QoL Score|
395809|NCT00465101|O1|Outcome|Number of Subjects With Baseline and 6 Month Values|The total number of patients that treated equals 136; the total number of patients with Baseline and 6 month values equals 117.
395810|NCT00465101|O1|Outcome|Number of Subjects With Baseline and 6 Month Values|The total number of patients that treated equals 136; the total number of patients with Baseline and 6 month values equals 117.
395811|NCT00465101|O1|Outcome|Treatment Related Complication at 3 Months|
395812|NCT00465101|O1|Outcome|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
395813|NCT00465101|E1|Reported Event|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
395814|NCT00465179|B1|Baseline|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
395815|NCT00465179|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
395816|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
395817|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
395818|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
395819|NCT00465179|E1|Reported Event|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
395820|NCT00466505|B1|Baseline|Therapeutic Intervention|
395821|NCT00466505|P1|Participant Flow|Therapeutic Intervention|
395822|NCT00466505|O1|Outcome|Therapeutic Intervention|
395823|NCT00466505|O1|Outcome|Therapeutic Intervention|
395824|NCT00466505|O1|Outcome|Therapeutic Intervention|
395825|NCT00466505|O1|Outcome|Therapeutic Intervention|
395826|NCT00466505|O1|Outcome|Therapeutic Intervention|
395827|NCT00466505|O1|Outcome|Therapeutic Intervention|
395828|NCT00466505|O1|Outcome|Therapeutic Intervention|
395829|NCT00466505|O1|Outcome|Therapeutic Intervention|
395830|NCT00466505|O1|Outcome|Therapeutic Intervention|
395831|NCT00466505|E1|Reported Event|Therapeutic Intervention|
395832|NCT00466687|B1|Baseline|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
395833|NCT00466687|P1|Participant Flow|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
395834|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
395835|NCT00466687|O1|Outcome|Therapeutic Intervention|Study drugs are administered on a 28-day cycle: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
397073|NCT00468585|O1|Outcome|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
395836|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
395837|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
395838|NCT00466687|E1|Reported Event|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
395839|NCT00466817|B3|Baseline|Total|Total of all reporting groups
395840|NCT00466817|B2|Baseline|Valganciclovir: 24 Wks of Valganciclovir|"Six months (6 weeks open label, 18 weeks blinded) of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395841|NCT00466817|B1|Baseline|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo (18 weeks) to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395842|NCT00466817|P2|Participant Flow|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395843|NCT00466817|P1|Participant Flow|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395844|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395845|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395846|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395847|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395848|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395849|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395850|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Vlaganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395851|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395852|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395853|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395854|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
396090|NCT00467363|B2|Baseline|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
450494|NCT00613106|B2|Baseline|Ibuprofen|Ibuprofen 800mg
395855|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395856|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395857|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395858|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395859|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395860|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395861|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395862|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395863|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395864|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395865|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395866|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395867|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395868|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395869|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395870|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395871|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395872|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395873|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395874|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395875|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395876|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395877|NCT00466817|O1|Outcome|Placebo: 6 Wks of Vlaganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395878|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395879|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395880|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395881|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395882|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395883|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395884|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395885|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395886|NCT00466817|O2|Outcome|Valganciclovir: 24 Weeks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395887|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395888|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395889|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395890|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.
Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
395891|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.
Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
395892|NCT00466817|E3|Reported Event|Placebo After 6 Weeks of Valganciclovir|6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded placebo
395893|NCT00466817|E2|Reported Event|Active|6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded valganciclovir
395894|NCT00466817|E1|Reported Event|Non Randomized|6 weeks of open label valganciclovir only
395895|NCT00466882|B1|Baseline|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
395896|NCT00466882|P1|Participant Flow|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
395897|NCT00466882|O1|Outcome|Group 1|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
395898|NCT00466882|E1|Reported Event|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
395899|NCT00466947|B3|Baseline|Total|Total of all reporting groups
395900|NCT00466947|B2|Baseline|Control Group|Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395901|NCT00466947|B1|Baseline|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395902|NCT00466947|P2|Participant Flow|Control Group|Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395903|NCT00466947|P1|Participant Flow|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395904|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395905|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395906|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395907|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395908|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395909|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395910|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395911|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395912|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396080|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
423847|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
395913|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395914|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395915|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395916|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395917|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395918|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395919|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395920|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395921|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395922|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395923|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395924|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395925|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395926|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395927|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395928|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395929|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395930|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395931|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395932|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395933|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395934|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395935|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395936|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395937|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395938|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395939|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395940|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395941|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395942|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395943|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395944|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395945|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395946|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395947|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395948|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395949|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395950|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395951|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395952|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395953|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395954|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395955|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395956|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395957|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395958|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395959|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395960|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395961|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395962|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395963|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395964|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395965|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395966|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395967|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395968|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395969|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395970|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395971|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395972|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395973|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395974|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395975|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395976|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395977|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395978|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395979|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395980|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395981|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395982|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395983|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395984|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395985|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395986|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395987|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395988|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395989|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395990|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395991|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395992|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395993|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395994|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395995|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395996|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395997|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
395998|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
395999|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396000|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396001|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396002|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396003|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396004|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396005|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396006|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396007|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396008|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396009|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396010|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396011|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396012|NCT00466947|O1|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396013|NCT00466947|O1|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396014|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396015|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396016|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396017|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396018|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396019|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396020|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396021|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396022|NCT00466947|E2|Reported Event|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
396023|NCT00466947|E1|Reported Event|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
396024|NCT00466960|B1|Baseline|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies"
396025|NCT00466960|P1|Participant Flow|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) subcutaneously (SC) once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies"
396026|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies"
396027|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies"
396081|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
396082|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
396028|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies"
396029|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies"
396030|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies"
396031|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies"
396032|NCT00466960|E1|Reported Event|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies"
396033|NCT00467038|B3|Baseline|Total|Total of all reporting groups
396034|NCT00467038|B2|Baseline|Healthy Controls|"Healthy controls
Age and gender matched healthy volunteers"
396035|NCT00467038|B1|Baseline|Dialectical Behavior Therapy|"Dialectical Behavior Therapy
Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
Event-related fMRI was obtained pre- and post-12-months of standard-DBT in unmedicatedBPD patients."
396036|NCT00467038|P2|Participant Flow|Healthy Controls|Healthy controls- no intervention
396037|NCT00467038|P1|Participant Flow|Dialectical Behavior Therapy|Participants receiving Dialectical Behavior Therapy
396038|NCT00467038|O2|Outcome|Healthy Controls|Healthy controls age- and gender-matched to other group of participants
396039|NCT00467038|O1|Outcome|Dialectical Behavior Therapy|Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
396040|NCT00467038|O2|Outcome|Healthy Controls|Healthy controls age- and gender-matched to other group of participants
396041|NCT00467038|O1|Outcome|Dialectical Behavior Therapy|"Dialectical Behavior Therapy
Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD"
396042|NCT00467038|E2|Reported Event|Arm 2|Healthy controls- no intervention
396043|NCT00467038|E1|Reported Event|Arm 1|"Dialectical Behavior Therapy
Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD"
396044|NCT00467051|B1|Baseline|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV dosage 135 mg/m2/dose
carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.
ifosfamide: Given IV dosage 1800 mg/m2/dose
filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2
laboratory biomarker analysis: Optional correlative studies"
396083|NCT00467285|O2|Outcome|Baseline Characteristics: Group 2|Mean age of 49 with mean BMI 0f 35.2 ± 5; HbA1C of 7.45
396084|NCT00467285|O1|Outcome|Baseline Characteristics: Group 1|Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
396085|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
396086|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
396087|NCT00467285|E2|Reported Event|No Pioglitazone|Subjects not on pioglitazone
396045|NCT00467051|P1|Participant Flow|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV dosage 135 mg/m2/dose
carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.
ifosfamide: Given IV dosage 1800 mg/m2/dose
filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2
laboratory biomarker analysis: Optional correlative studies"
396046|NCT00467051|O1|Outcome|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV dosage 135 mg/m2/dose
carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.
ifosfamide: Given IV dosage 1800 mg/m2/dose
filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2
laboratory biomarker analysis: Optional correlative studies"
396047|NCT00467051|E1|Reported Event|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV dosage 135 mg/m2/dose
carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.
ifosfamide: Given IV dosage 1800 mg/m2/dose
filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2
laboratory biomarker analysis: Optional correlative studies"
396048|NCT00467077|B1|Baseline|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
396049|NCT00467077|P1|Participant Flow|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
396050|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
396051|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
396052|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
396053|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
396054|NCT00467077|E1|Reported Event|Arm 1|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
396055|NCT00467259|B3|Baseline|Total|Total of all reporting groups
396056|NCT00467259|B2|Baseline|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
396057|NCT00467259|B1|Baseline|Placebo|Placebo patch
396058|NCT00467259|P2|Participant Flow|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
396059|NCT00467259|P1|Participant Flow|Placebo|Placebo patch
396060|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
396061|NCT00467259|O1|Outcome|Placebo|Placebo patch
396062|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
396063|NCT00467259|O1|Outcome|Placebo|Placebo patch
396064|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
396065|NCT00467259|O1|Outcome|Placebo|Placebo patch
396066|NCT00467259|E2|Reported Event|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
396067|NCT00467259|E1|Reported Event|Placebo|Placebo patch
396068|NCT00467285|B3|Baseline|Total|Total of all reporting groups
396069|NCT00467285|B2|Baseline|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
396070|NCT00467285|B1|Baseline|Pioglitazone|32 subjects with type 2 diabetes on pioglitazone.
396071|NCT00467285|P2|Participant Flow|Group 2|64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
396072|NCT00467285|P1|Participant Flow|Group 1|32 subjects with type 2 diabetes on pioglitazone.
396073|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
396074|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
396075|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
396076|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
396077|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
396078|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
396091|NCT00467363|B1|Baseline|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396092|NCT00467363|P2|Participant Flow|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396093|NCT00467363|P1|Participant Flow|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396094|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396095|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396096|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396097|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396098|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396099|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396100|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396101|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396102|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396103|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396104|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396105|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396106|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396107|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396108|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396109|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396110|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396111|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396112|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396113|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396114|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396115|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396116|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396117|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396118|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396119|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396120|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396121|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396122|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396123|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396124|NCT00467363|E2|Reported Event|Placebo|"400micrograms of folic acid.
Folic acid: 400micrograms of folic acid."
396125|NCT00467363|E1|Reported Event|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.
acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
396126|NCT00467389|B1|Baseline|All Participants|All recruited subjects
396127|NCT00467389|P2|Participant Flow|Donepezil Treatment First|Participants initially treated with oral donepezil, and later treated with oral placebo
396128|NCT00467389|P1|Participant Flow|Placebo Treatment First|Participants initially treated with oral placebo, and later treated with oral donepezil
396129|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
396130|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
396131|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
396132|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
396133|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
396134|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
396135|NCT00467389|E2|Reported Event|Donepezil Treatment Period|Active Treatment
396136|NCT00467389|E1|Reported Event|Placebo Treatment Period|Inactive Comparator.
396137|NCT00467519|B3|Baseline|Total|Total of all reporting groups
396138|NCT00467519|B2|Baseline|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
396264|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396139|NCT00467519|B1|Baseline|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
396140|NCT00467519|P2|Participant Flow|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
396141|NCT00467519|P1|Participant Flow|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
396142|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
396143|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
396144|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
396145|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
396146|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
396147|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
396148|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
396149|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
396150|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
396151|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
396152|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
396153|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
396154|NCT00467519|E2|Reported Event|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
396155|NCT00467519|E1|Reported Event|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
396156|NCT00467558|B3|Baseline|Total|Total of all reporting groups
396157|NCT00467558|B2|Baseline|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
396158|NCT00467558|B1|Baseline|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
396159|NCT00467558|P2|Participant Flow|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
396160|NCT00467558|P1|Participant Flow|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
396161|NCT00467558|O2|Outcome|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
396162|NCT00467558|O1|Outcome|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
396163|NCT00467558|O2|Outcome|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
396164|NCT00467558|O1|Outcome|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
396165|NCT00467558|E2|Reported Event|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
396166|NCT00467558|E1|Reported Event|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
396167|NCT00467584|B4|Baseline|Total|Total of all reporting groups
396168|NCT00467584|B3|Baseline|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
396169|NCT00467584|B2|Baseline|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
396170|NCT00467584|B1|Baseline|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
396171|NCT00467584|P3|Participant Flow|Placebo|"Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
Placebo: Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks"
396172|NCT00467584|P2|Participant Flow|Low Dose Aspirin|"Low Dose Aspirin; 162 milligrams of aspirin per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks
Low Dose Aspirin (162 mg/day): 162 milligrams per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks"
396173|NCT00467584|P1|Participant Flow|High Dose Aspirin|"High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
High Dose Aspirin (1300 mg/day): 1300 milligrams per day (the equivalent of 4 regular aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks"
396174|NCT00467584|O3|Outcome|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
396175|NCT00467584|O2|Outcome|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
396176|NCT00467584|O1|Outcome|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
396177|NCT00467584|E3|Reported Event|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
396178|NCT00467584|E2|Reported Event|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
396179|NCT00467584|E1|Reported Event|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
396180|NCT00467597|B5|Baseline|Total|Total of all reporting groups
396181|NCT00467597|B4|Baseline|Controls - No PD|Controls with no Parkinson's disease
396182|NCT00467597|B3|Baseline|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
396183|NCT00467597|B2|Baseline|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
396184|NCT00467597|B1|Baseline|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
396185|NCT00467597|P2|Participant Flow|Controls|Non-Parkinson's Disease Controls (no intervention).
396186|NCT00467597|P1|Participant Flow|Parkinson's Disease|Parkinson's disease with and without Levodopa-Induced Dyskinesia (no intervention).
396187|NCT00467597|O4|Outcome|Controls - No PD|Controls with no Parkinson's disease
396188|NCT00467597|O3|Outcome|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
396189|NCT00467597|O2|Outcome|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
396190|NCT00467597|O1|Outcome|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
396191|NCT00467597|E4|Reported Event|Controls - No PD|Controls with no Parkinson's disease
396192|NCT00467597|E3|Reported Event|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
396193|NCT00467597|E2|Reported Event|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
396194|NCT00467597|E1|Reported Event|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
396195|NCT00467610|B1|Baseline|Group 1|Panhematin treatment arm
396196|NCT00467610|P1|Participant Flow|Group 1|Panhematin treatment arm
396197|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
396198|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
396199|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
396200|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
396201|NCT00467610|E1|Reported Event|Group 1|Panhematin treatment arm
396202|NCT00467649|B3|Baseline|Total|Total of all reporting groups
396203|NCT00467649|B2|Baseline|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396204|NCT00467649|B1|Baseline|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396205|NCT00467649|P6|Participant Flow|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
396206|NCT00467649|P5|Participant Flow|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
396207|NCT00467649|P4|Participant Flow|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
396208|NCT00467649|P3|Participant Flow|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
396209|NCT00467649|P2|Participant Flow|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396210|NCT00467649|P1|Participant Flow|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396211|NCT00467649|O6|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
396212|NCT00467649|O5|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
396213|NCT00467649|O4|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
396214|NCT00467649|O3|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
396215|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396216|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396217|NCT00467649|O4|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
396218|NCT00467649|O3|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
396219|NCT00467649|O2|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
396220|NCT00467649|O1|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
396221|NCT00467649|O4|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
396263|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396222|NCT00467649|O3|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
396223|NCT00467649|O2|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
396224|NCT00467649|O1|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
396225|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396226|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396227|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396228|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396229|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396230|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396231|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396232|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396233|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396234|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396235|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396236|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396237|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396238|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396239|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396240|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396241|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396242|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396243|NCT00467649|E6|Reported Event|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
396244|NCT00467649|E5|Reported Event|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
396245|NCT00467649|E4|Reported Event|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
396246|NCT00467649|E3|Reported Event|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
396247|NCT00467649|E2|Reported Event|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
396248|NCT00467649|E1|Reported Event|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
396249|NCT00467740|B6|Baseline|Total|Total of all reporting groups
396250|NCT00467740|B5|Baseline|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396251|NCT00467740|B4|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396252|NCT00467740|B3|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396253|NCT00467740|B2|Baseline|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396254|NCT00467740|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396255|NCT00467740|P5|Participant Flow|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396256|NCT00467740|P4|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396257|NCT00467740|P3|Participant Flow|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396258|NCT00467740|P2|Participant Flow|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396259|NCT00467740|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396260|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396261|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396262|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396265|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396266|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396267|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396268|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396269|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396270|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396271|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396272|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396273|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396274|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396275|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396276|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396277|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396278|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396279|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396280|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396281|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396282|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396283|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396284|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396285|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396286|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396287|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396288|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396289|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396290|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396291|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396292|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396293|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396294|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396295|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396296|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396297|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396298|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396299|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396300|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396301|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396302|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396303|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396304|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396305|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396306|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396307|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396308|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396309|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396310|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396311|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396312|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396313|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396314|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396315|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396316|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396317|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396318|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396319|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396320|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396321|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396322|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396323|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396324|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396325|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396326|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396327|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396328|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396329|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396330|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396331|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396332|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396333|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396334|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396335|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396336|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396337|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396338|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396339|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396340|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396341|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396342|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396343|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396344|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396345|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396346|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396347|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396348|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396349|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396350|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396351|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396352|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396353|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396354|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396355|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396356|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396357|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396358|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396359|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396360|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396361|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396362|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396363|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396364|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396365|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396366|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396367|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396368|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396369|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396370|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396371|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396372|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396373|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396374|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396375|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396376|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396377|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396378|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396379|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396380|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396381|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396382|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396383|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396384|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396385|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396386|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396387|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396388|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396389|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396390|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396391|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396392|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396393|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396394|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396395|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396396|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396397|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396398|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396399|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396400|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396401|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396402|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396403|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396404|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396405|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396406|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396407|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396408|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396409|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396410|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396411|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396412|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396413|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396414|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396415|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396416|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396417|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396418|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396419|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396420|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396421|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396422|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396423|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396424|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396425|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396426|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396427|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396428|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396429|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396430|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396431|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396432|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396433|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396434|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396435|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396436|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396437|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396438|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396439|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396440|NCT00467740|E5|Reported Event|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
396441|NCT00467740|E4|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
396442|NCT00467740|E3|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
396443|NCT00467740|E2|Reported Event|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
396444|NCT00467740|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
396447|NCT00467753|B1|Baseline|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm
Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
396448|NCT00467753|P2|Participant Flow|Sugar Pill|Placebo : Dosage similar to active drug
396449|NCT00467753|P1|Participant Flow|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm
Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
396450|NCT00467753|O2|Outcome|Sugar Pill|Placebo : Dosage similar to active drug
396451|NCT00467753|O1|Outcome|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm
Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
396452|NCT00467753|E2|Reported Event|Sugar Pill|Placebo : Dosage similar to active drug
396453|NCT00467753|E1|Reported Event|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm
Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
396454|NCT00467779|B16|Baseline|Total|Total of all reporting groups
396455|NCT00467779|B15|Baseline|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
396456|NCT00467779|B14|Baseline|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396457|NCT00467779|B13|Baseline|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396458|NCT00467779|B12|Baseline|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396459|NCT00467779|B11|Baseline|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396460|NCT00467779|B10|Baseline|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396461|NCT00467779|B9|Baseline|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396462|NCT00467779|B8|Baseline|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396463|NCT00467779|B7|Baseline|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396690|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396725|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
397074|NCT00468585|E4|Reported Event|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
396464|NCT00467779|B6|Baseline|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396465|NCT00467779|B5|Baseline|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396466|NCT00467779|B4|Baseline|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396467|NCT00467779|B3|Baseline|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396468|NCT00467779|B2|Baseline|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396469|NCT00467779|B1|Baseline|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396470|NCT00467779|P15|Participant Flow|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
396471|NCT00467779|P14|Participant Flow|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396472|NCT00467779|P13|Participant Flow|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396473|NCT00467779|P12|Participant Flow|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396474|NCT00467779|P11|Participant Flow|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396475|NCT00467779|P10|Participant Flow|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396476|NCT00467779|P9|Participant Flow|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396477|NCT00467779|P8|Participant Flow|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396478|NCT00467779|P7|Participant Flow|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396479|NCT00467779|P6|Participant Flow|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396480|NCT00467779|P5|Participant Flow|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396481|NCT00467779|P4|Participant Flow|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396482|NCT00467779|P3|Participant Flow|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396719|NCT00467870|P4|Participant Flow|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
396483|NCT00467779|P2|Participant Flow|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396484|NCT00467779|P1|Participant Flow|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 milligrams per kilograms (mg/kg) via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396485|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
396486|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
396487|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
396488|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
396489|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
396490|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
396491|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396492|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396493|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396494|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396495|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396496|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396497|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396720|NCT00467870|P3|Participant Flow|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
396498|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396499|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396500|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396501|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396502|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396503|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396504|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396505|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396506|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396507|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396508|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396509|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396510|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396511|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396512|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396513|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396514|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396515|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396516|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396517|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
397070|NCT00468585|O4|Outcome|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
396518|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396519|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396520|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396521|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396522|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396523|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396524|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396525|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396526|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396527|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396528|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396529|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396530|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396531|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396532|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396533|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396534|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396535|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396536|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396537|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396538|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396539|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396540|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396541|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396542|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396543|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396544|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396545|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396546|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396547|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396548|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396549|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396550|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396551|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396552|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396553|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396554|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396555|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396556|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396557|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396721|NCT00467870|P2|Participant Flow|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
396558|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396559|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396560|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396561|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396562|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396563|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396564|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396565|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396566|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396567|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396568|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396569|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396570|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396571|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396572|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396573|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396574|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396575|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396576|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396577|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396578|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396579|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396580|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396581|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396582|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396583|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396584|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396585|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396586|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396587|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396588|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396589|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396590|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396591|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396592|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396593|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396594|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396595|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396596|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396597|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396722|NCT00467870|P1|Participant Flow|A-TU 750 mg|750 mg testosterone undecanoate (TU) in 3 mL oily solution, intramuscularly (IM) every 12 weeks for up to 3 years in Part A
396598|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396599|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396600|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396601|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396602|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396603|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396604|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396605|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396606|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396607|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396608|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396609|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396610|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396611|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396612|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396613|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396614|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396615|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396616|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396617|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396618|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396619|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396620|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396621|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396622|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396623|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396624|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396625|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396626|NCT00467779|O1|Outcome|Stage 1A - All Cohorts (14/14)|Participants received cobimetinib via solution or capsule, once daily for Days 1-14 of each 28-day cycle and were on a 14-days-on and 14-days-off schedule. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396627|NCT00467779|O1|Outcome|Stage 1 All Cohorts (21/7)|Participants received cobimetinib via solution or capsule, once daily for Days 1-21 of each 28-day cycle and were on 21-days-on and 7-days-off schedule. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396628|NCT00467779|O12|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396629|NCT00467779|O11|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396630|NCT00467779|O10|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396631|NCT00467779|O9|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396632|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396633|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396634|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396635|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396636|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396637|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396723|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
396638|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396639|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396640|NCT00467779|E15|Reported Event|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period. Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
396641|NCT00467779|E14|Reported Event|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396642|NCT00467779|E13|Reported Event|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396643|NCT00467779|E12|Reported Event|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396644|NCT00467779|E11|Reported Event|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396645|NCT00467779|E10|Reported Event|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396646|NCT00467779|E9|Reported Event|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396647|NCT00467779|E8|Reported Event|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396648|NCT00467779|E7|Reported Event|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396649|NCT00467779|E6|Reported Event|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396650|NCT00467779|E5|Reported Event|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396651|NCT00467779|E4|Reported Event|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396652|NCT00467779|E3|Reported Event|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396653|NCT00467779|E2|Reported Event|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396654|NCT00467779|E1|Reported Event|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
396655|NCT00467831|B1|Baseline|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.
Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.
Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.
Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.
N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.
Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
396724|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
396656|NCT00467831|P1|Participant Flow|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.
Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.
Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.
Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.
N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.
Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
396657|NCT00467831|O1|Outcome|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.
Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.
Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.
Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.
N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.
Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
396658|NCT00467831|E1|Reported Event|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.
Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.
Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.
Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.
N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.
Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
396659|NCT00467844|B4|Baseline|Total|Total of all reporting groups
396660|NCT00467844|B3|Baseline|3 mg of Placebo|Placebo
396661|NCT00467844|B2|Baseline|GTx-024|3 mg
396662|NCT00467844|B1|Baseline|GTx -024|1 mg
396663|NCT00467844|P3|Participant Flow|3 mg of Placebo|Placebo
396664|NCT00467844|P2|Participant Flow|GTx-024|3 mg
396665|NCT00467844|P1|Participant Flow|GTx -024|1 mg
396666|NCT00467844|O3|Outcome|3 mg of Placebo|Placebo
396667|NCT00467844|O2|Outcome|GTx-024|3 mg
396668|NCT00467844|O1|Outcome|GTx -024|1 mg
396669|NCT00467844|O3|Outcome|Placebo|Placebo
396670|NCT00467844|O2|Outcome|GTx-024 3 mg|
396671|NCT00467844|O1|Outcome|GTx-024 1 mg|
396672|NCT00467844|E3|Reported Event|3 mg of Placebo|Placebo
396673|NCT00467844|E2|Reported Event|GTx-024|3 mg
396674|NCT00467844|E1|Reported Event|GTx -024|1 mg
396675|NCT00467857|B3|Baseline|Total|Total of all reporting groups
396676|NCT00467857|B2|Baseline|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396677|NCT00467857|B1|Baseline|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396678|NCT00467857|P2|Participant Flow|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396679|NCT00467857|P1|Participant Flow|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396680|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396681|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396682|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396683|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396684|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396685|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396686|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396687|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396688|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396689|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396691|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396692|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396693|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396694|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396695|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396696|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396697|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396698|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396699|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396700|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396701|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396702|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396703|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396704|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396705|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396706|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396707|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396708|NCT00467857|E2|Reported Event|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
396709|NCT00467857|E1|Reported Event|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
396710|NCT00467870|B7|Baseline|Total|Total of all reporting groups
396711|NCT00467870|B6|Baseline|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
396712|NCT00467870|B5|Baseline|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396713|NCT00467870|B4|Baseline|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
396714|NCT00467870|B3|Baseline|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
396715|NCT00467870|B2|Baseline|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
396716|NCT00467870|B1|Baseline|A-TU 750 mg|750 mg TU in 3 mL oily solution, IM every 12 weeks for up to 3 years in Part A
396717|NCT00467870|P6|Participant Flow|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
396718|NCT00467870|P5|Participant Flow|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396883|NCT00468312|B2|Baseline|Placebo|Two sprays in each nostril once daily
396726|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
396727|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
396728|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
396729|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396730|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396731|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396732|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396733|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396734|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396735|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396736|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396737|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396738|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396739|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396740|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396741|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396742|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396743|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396744|NCT00467870|O2|Outcome|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
396745|NCT00467870|O1|Outcome|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
396746|NCT00467870|O2|Outcome|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
396747|NCT00467870|O1|Outcome|A-TU 750 mg|750 mg TU in 3 mL oily solution, IM every 12 weeks for up to 3 years in Part A
396748|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
396749|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
396750|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
396751|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
396752|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396753|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396754|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396755|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396756|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396757|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396758|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396759|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
396760|NCT00467870|E2|Reported Event|TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at any time during the study in Part A or B (includes participants from A-1000 mg, B-750 mg, and B-1000 mg)
396761|NCT00467870|E1|Reported Event|TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline and during the study in Part A, C, or C2 (includes participants from A-750 mg, C-750 mg, and C2-750 mg)
396762|NCT00467896|B1|Baseline|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
396763|NCT00467896|P1|Participant Flow|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
396764|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) in Period I and Power Disc-15 (PD-15)in Period II.
396765|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
396766|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
396767|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
396768|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
396769|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
396770|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
396771|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
396772|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
396773|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
396774|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
396775|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
396776|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
396777|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
396778|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
396779|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
396780|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
396781|NCT00467896|E1|Reported Event|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
396782|NCT00467961|B1|Baseline|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
396783|NCT00467961|P1|Participant Flow|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
396784|NCT00467961|O1|Outcome|Selective T Cell Depletion Transplant Recipients|"Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach (Kiadis Pharma). Older subjects will receive a lower dose of irradiation to reduce the regimen intensity.
To determine appropriate level of post transplant immunosuppression."
396785|NCT00467961|E1|Reported Event|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
396786|NCT00468052|B3|Baseline|Total|Total of all reporting groups
396787|NCT00468052|B2|Baseline|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
396788|NCT00468052|B1|Baseline|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.
0"
396789|NCT00468052|P2|Participant Flow|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
396790|NCT00468052|P1|Participant Flow|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.
0"
396791|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1
dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
396792|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1
fentanyl: 1 microgram/kilogram as a bolus"
396793|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1
dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
396794|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1
fentanyl: 1 microgram/kilogram as a bolus"
396795|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
396796|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.
0"
396797|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
396798|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.
0"
396799|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
396800|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.
0"
396801|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1
dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
396802|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1
fentanyl: 1 microgram/kilogram as a bolus"
396803|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
396804|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.
0"
396805|NCT00468052|E2|Reported Event|Dexmedetomidine|1 subjects Group D experienced an adverse event.
396806|NCT00468052|E1|Reported Event|Fentanyl (F) Group|"No subjects in group F experienced an adverse event.
0"
396807|NCT00468104|B1|Baseline|Alteplase; Placebo|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally; 100 cc of normal saline instilled intrapleurally
396808|NCT00468104|P2|Participant Flow|Placebo Then Alteplase|Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Alteplase)
396809|NCT00468104|P1|Participant Flow|Alteplase Then Placebo|25 mg of Alteplase in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Placebo)
396810|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
396811|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
396812|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
396813|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
396814|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
396815|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
396816|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
396817|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
396818|NCT00468104|O2|Outcome|Placebo|Placebo in 100 cc of normal saline given daily intrapleurally for 3 days either in the first or second arm
396819|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline given intrapleurally daily for 3 days either in the first or second arm
396820|NCT00468104|E3|Reported Event|Received Both Alteplase and Placebo|These patients were crossed over and received both Alteplase and Placebo
396821|NCT00468104|E2|Reported Event|Received Placebo Only|These patients received Placebo only and were not crossed over
396822|NCT00468104|E1|Reported Event|Received Alteplase Only|These patients received only Alteplase and were not crossed over
396823|NCT00468143|B1|Baseline|All Participants|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
396824|NCT00468143|P2|Participant Flow|Immediate Release First|This group received the immediate release medication during the first three weeks of treatment and then received the extended release medication during the last 3 weeks of treatment.
396825|NCT00468143|P1|Participant Flow|Extended Release First|This group received the extended release medication during the first three weeks of treatment and then received the immediate release medication during the last 3 weeks of treatment.
396826|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
396827|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
396828|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
396829|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
396830|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
396831|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
397071|NCT00468585|O3|Outcome|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
396832|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
396833|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
396834|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
396835|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
396836|NCT00468143|E2|Reported Event|Immediate Release|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
396837|NCT00468143|E1|Reported Event|Extended Release|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
396838|NCT00468208|B1|Baseline|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.
Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:
500 mg of abatacept for body weight less than 60 kg
750 mg of abatacept for body weight between 60 and 100 kg
1000 mg of abatacept for body weight greater than 100 kg
Abatacept was administered in a 30-minute intravenous infusion."
396839|NCT00468208|P1|Participant Flow|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.
Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:
500 mg of abatacept for body weight less than 60 kg
750 mg of abatacept for body weight between 60 and 100 kg
1000 mg of abatacept for body weight greater than 100 kg
Abatacept was administered in a 30-minute intravenous infusion."
396840|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.
Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:
500 mg of abatacept for body weight less than 60 kg
750 mg of abatacept for body weight between 60 and 100 kg
1000 mg of abatacept for body weight greater than 100 kg
Abatacept was administered in a 30-minute intravenous infusion."
396841|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.
Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:
500 mg of abatacept for body weight less than 60 kg
750 mg of abatacept for body weight between 60 and 100 kg
1000 mg of abatacept for body weight greater than 100 kg
Abatacept was administered in a 30-minute intravenous infusion."
396842|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.
Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:
500 mg of abatacept for body weight less than 60 kg
750 mg of abatacept for body weight between 60 and 100 kg
1000 mg of abatacept for body weight greater than 100 kg
Abatacept was administered in a 30-minute intravenous infusion."
396843|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.
Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:
500 mg of abatacept for body weight less than 60 kg
750 mg of abatacept for body weight between 60 and 100 kg
1000 mg of abatacept for body weight greater than 100 kg
Abatacept was administered in a 30-minute intravenous infusion."
396844|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.
Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:
500 mg of abatacept for body weight less than 60 kg
750 mg of abatacept for body weight between 60 and 100 kg
1000 mg of abatacept for body weight greater than 100 kg
Abatacept was administered in a 30-minute intravenous infusion."
396845|NCT00468208|E1|Reported Event|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.
Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:
500 mg of abatacept for body weight less than 60 kg
750 mg of abatacept for body weight between 60 and 100 kg
1000 mg of abatacept for body weight greater than 100 kg
Abatacept was administered in a 30-minute intravenous infusion."
396846|NCT00468286|B3|Baseline|Total|Total of all reporting groups
396847|NCT00468286|B2|Baseline|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
397061|NCT00468585|B5|Baseline|Total|Total of all reporting groups
396848|NCT00468286|B1|Baseline|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396849|NCT00468286|P2|Participant Flow|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396850|NCT00468286|P1|Participant Flow|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396851|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396852|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396853|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396854|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396855|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396856|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396857|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396858|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396859|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396860|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396861|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396862|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396863|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396864|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396865|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396866|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396867|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396868|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396869|NCT00468286|E2|Reported Event|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396870|NCT00468286|E1|Reported Event|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
396871|NCT00468299|B3|Baseline|Total|Total of all reporting groups
396872|NCT00468299|B2|Baseline|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
396873|NCT00468299|B1|Baseline|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
396874|NCT00468299|P2|Participant Flow|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
396875|NCT00468299|P1|Participant Flow|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
396876|NCT00468299|O2|Outcome|Mifepristone and Misoprostol|Women received mifeppristone 200 mg orally followed ny misoprostol 800 mcg buccally
396877|NCT00468299|O1|Outcome|Misoprostol and Placebo|Women received a placebo followed by misoprostol 800 mcg buccally
396878|NCT00468299|O2|Outcome|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
396879|NCT00468299|O1|Outcome|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
396880|NCT00468299|E2|Reported Event|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
396881|NCT00468299|E1|Reported Event|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
396882|NCT00468312|B3|Baseline|Total|Total of all reporting groups
396884|NCT00468312|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
396885|NCT00468312|P2|Participant Flow|Placebo|Two sprays in each nostril once daily
396886|NCT00468312|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
396887|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
396888|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
396889|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
396890|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
396891|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
396892|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
396893|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
396894|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
396895|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
396896|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
396897|NCT00468312|E2|Reported Event|Placebo|Two sprays in each nostril once daily
396898|NCT00468312|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
396899|NCT00468481|B3|Baseline|Total|Total of all reporting groups
396900|NCT00468481|B2|Baseline|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396901|NCT00468481|B1|Baseline|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396902|NCT00468481|P2|Participant Flow|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396903|NCT00468481|P1|Participant Flow|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396904|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396905|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396906|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396907|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396908|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396909|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396910|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396911|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396912|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396913|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396914|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396915|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396916|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396917|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
397062|NCT00468585|B4|Baseline|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
423848|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
396918|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396919|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396920|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396921|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396922|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396923|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396924|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396925|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396926|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396927|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396928|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396929|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396930|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396931|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396932|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396933|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396934|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396935|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396936|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396937|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396938|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396939|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396940|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396941|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396942|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396943|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
397063|NCT00468585|B3|Baseline|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
397064|NCT00468585|B2|Baseline|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
396944|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396945|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396946|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396947|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396948|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396949|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396950|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396951|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396952|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396953|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396954|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396955|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396956|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396957|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396958|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396959|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396960|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396961|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396962|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396963|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396964|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396965|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396966|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396967|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396968|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396969|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
397065|NCT00468585|B1|Baseline|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
397066|NCT00468585|P4|Participant Flow|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
396970|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396971|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396972|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396973|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396974|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396975|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396976|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396977|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396978|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396979|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396980|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396981|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396982|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396983|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396984|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396985|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396986|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396987|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396988|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396989|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396990|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396991|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396992|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396993|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396994|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396995|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
397067|NCT00468585|P3|Participant Flow|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
397068|NCT00468585|P2|Participant Flow|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
396996|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396997|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
396998|NCT00468481|E2|Reported Event|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
396999|NCT00468481|E1|Reported Event|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
397000|NCT00468546|B3|Baseline|Total|Total of all reporting groups
397001|NCT00468546|B2|Baseline|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397002|NCT00468546|B1|Baseline|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397003|NCT00468546|P2|Participant Flow|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397004|NCT00468546|P1|Participant Flow|Placebo Plus Methotrexate|Eligible participants were administered the placebo by intravenous infusion on Days 1 and 15 along with methotrexate (MTX) 10-25 milligrams (mg) per os (p.o.) or parenterally once a week up to Week 24 and were followed up to Week 104.
397005|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397006|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397007|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397008|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397009|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397010|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397011|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397012|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397013|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397014|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397015|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397016|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397017|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397018|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397019|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397020|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397021|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397022|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397023|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397069|NCT00468585|P1|Participant Flow|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
397024|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397025|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397026|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397027|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397028|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397029|NCT00468546|E2|Reported Event|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
397030|NCT00468546|E1|Reported Event|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
397031|NCT00468559|B3|Baseline|Total|Total of all reporting groups
397032|NCT00468559|B2|Baseline|Double Blind Placebo|
397033|NCT00468559|B1|Baseline|Double Blind Esomeprazole|
397034|NCT00468559|P3|Participant Flow|Double Blind Placebo|
397035|NCT00468559|P2|Participant Flow|Double Blind Esomeprazole|
397036|NCT00468559|P1|Participant Flow|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight). Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
397037|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
397038|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
397039|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
397040|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
397041|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
397042|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
397043|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
397044|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
397045|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
397046|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
397047|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
397048|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
397049|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
397050|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
397051|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
397052|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
397053|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
397054|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
397055|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
397056|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
397057|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
397058|NCT00468559|E3|Reported Event|Double Blind Placebo|Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
397059|NCT00468559|E2|Reported Event|Double Blind Esomeprazole|Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
397060|NCT00468559|E1|Reported Event|Open-label Phase|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight).
397075|NCT00468585|E3|Reported Event|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
397076|NCT00468585|E2|Reported Event|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
397077|NCT00468585|E1|Reported Event|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
397078|NCT00468650|B1|Baseline|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397079|NCT00468650|P1|Participant Flow|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397080|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397081|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397082|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397083|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397084|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397085|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397086|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397087|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397088|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397089|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397090|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397091|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397092|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397093|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397094|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
423849|NCT00543725|E2|Reported Event|Efavirenz|600 mg once daily
397095|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
451052|NCT00616629|B5|Baseline|Placebo|Corresponding placebo
397096|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397097|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397098|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397099|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397100|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397101|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397102|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397103|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397104|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397105|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397106|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397107|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397108|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397109|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397110|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397111|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397112|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397113|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397144|NCT00468728|B1|Baseline|Vancomycin|125 mg administered 4 times daily (q6hr)
397114|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397115|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397116|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397117|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397118|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397119|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397120|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397121|NCT00468650|E1|Reported Event|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
397122|NCT00468676|B3|Baseline|Total|Total of all reporting groups
397123|NCT00468676|B2|Baseline|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
397124|NCT00468676|B1|Baseline|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
397125|NCT00468676|P2|Participant Flow|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
397126|NCT00468676|P1|Participant Flow|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 (Patient Health Questionnaire 9) score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
397127|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
397128|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
397145|NCT00468728|P2|Participant Flow|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
397146|NCT00468728|P1|Participant Flow|Vancomycin|125 mg administered 4 times daily (q6hr)
397147|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
397148|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
397149|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily
397151|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
397152|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
397153|NCT00468728|E2|Reported Event|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
397129|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
397130|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
397131|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
397132|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
397133|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
397134|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
397135|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
397136|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
397137|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
397138|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
397139|NCT00468676|O1|Outcome|Effect Size of Invervention Group to Standard Care|This was an intent to treat analysis calculating the intervention effect size of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes combined
397140|NCT00468676|E2|Reported Event|Care Management Intervention|"Care management intervention
Nurse-led case management: The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress."
397141|NCT00468676|E1|Reported Event|Usual Care|"Treatment as usual
Treatment as usual: Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care."
397142|NCT00468728|B3|Baseline|Total|Total of all reporting groups
397143|NCT00468728|B2|Baseline|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
397154|NCT00468728|E1|Reported Event|Vancomycin|125 mg administered 4 times daily (q6hr)
397155|NCT00468819|B4|Baseline|Total|Total of all reporting groups
397156|NCT00468819|B3|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397157|NCT00468819|B2|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397158|NCT00468819|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397159|NCT00468819|P3|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397160|NCT00468819|P2|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397161|NCT00468819|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397162|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397163|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397164|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397165|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397166|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397167|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397168|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397169|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397170|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397171|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397172|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397173|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397174|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397175|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397176|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397177|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397178|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397179|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397180|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397181|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397182|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397183|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397184|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397185|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397186|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397187|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397188|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397189|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397278|NCT00476021|O2|Outcome|Delayed IUD Insertion|Delayed LNG-IUD insertion
397190|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397191|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397192|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397193|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397194|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397195|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397196|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397197|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397198|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397199|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397200|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397201|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397202|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397203|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397204|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397205|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397206|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397207|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397208|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397209|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397210|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397211|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397212|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397213|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397214|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397215|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397216|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397217|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397218|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397219|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397220|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397221|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397222|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397223|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397275|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
397224|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397225|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397226|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397227|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397228|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397229|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397230|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397231|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397232|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397233|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397234|NCT00468819|E4|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397235|NCT00468819|E3|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397236|NCT00468819|E2|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397237|NCT00468819|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
397238|NCT00476008|B3|Baseline|Total|Total of all reporting groups
397239|NCT00476008|B2|Baseline|Placebo|Placebo : Placebo BID for 12 months
397240|NCT00476008|B1|Baseline|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397241|NCT00476008|P2|Participant Flow|Placebo|Placebo : Placebo BID for 12 months
397242|NCT00476008|P1|Participant Flow|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397243|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397244|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
397245|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397246|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
397247|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397248|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
397249|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397250|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
397251|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397252|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
397253|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397254|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
397255|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397256|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
397257|NCT00476008|O2|Outcome|Memantine|Memantine: One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months
397258|NCT00476008|O1|Outcome|Placebo|Placebo: One tablet placebo morning and evening (BID) for 12 months
397259|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397260|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
397261|NCT00476008|O2|Outcome|Placebo|Placebo : Placebo BID for 12 months
397262|NCT00476008|O1|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397263|NCT00476008|E2|Reported Event|Placebo|Placebo : Placebo BID for 12 months
397264|NCT00476008|E1|Reported Event|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
397265|NCT00476021|B3|Baseline|Total|Total of all reporting groups
397266|NCT00476021|B2|Baseline|Delayed IUD Insertion (6-8 Weeks After Delivery)|"delayed IUD insertion (6-8 weeks after delivery)
Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years"
397267|NCT00476021|B1|Baseline|Immediate Postplacental IUD Insertion|"immediate postplacental IUD insertion
Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years"
397268|NCT00476021|P2|Participant Flow|Delayed IUD Insertion|Delayed LNG-IUD insertion
397269|NCT00476021|P1|Participant Flow|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
397270|NCT00476021|O2|Outcome|Follow-up for IUD Insertion for Ineligible Participants|Ineligible participants were followed for 6 months to evaluate whether they received an IUD from their ob/gyn
397271|NCT00476021|O1|Outcome|Pregnancy Within 6 Months for Ineligible Participants|If a participant was found to be ineligible as a result of postenrollment criteria, she was instructed to follow up with her primary obstetrician or midwife for postpartum contraception and delayed IUD insertion
397272|NCT00476021|O2|Outcome|Delayed IUD Insertion|Infection after delayed LNG-IUD insertion
397273|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Infection after postplacental LNG-IUD insertion
397274|NCT00476021|O2|Outcome|Delayed IUD Insertion|Delayed LNG-IUD insertion
397276|NCT00476021|O1|Outcome|Delayed IUD Insertion|Followed up for delayed IUD insertion
397277|NCT00476021|O1|Outcome|Received Postplacental IUD|Received postplacental LNG-IUD
397279|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
397280|NCT00476021|E2|Reported Event|Delayed IUD Insertion|Delayed LNG-IUD insertion
397281|NCT00476021|E1|Reported Event|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
397282|NCT00476086|B1|Baseline|Oxaliplatin/ Gemcitabine Then Radiation|"Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
on"
397283|NCT00476086|P1|Participant Flow|Oxaliplatin/ Gemcitabine Then Radiation|Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
397284|NCT00476086|O1|Outcome|Oxaliplatin/ Gemcitabine Then Radiation|Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
397285|NCT00476086|O1|Outcome|Oxaliplatin/ Gemcitabine Then Radiation|Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
397286|NCT00476086|E2|Reported Event|Radiation|On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
397287|NCT00476086|E1|Reported Event|Oxaliplatin/ Gemcitabine|Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted.
397288|NCT00476151|B3|Baseline|Total|Total of all reporting groups
397289|NCT00476151|B2|Baseline|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
397290|NCT00476151|B1|Baseline|Placebo Cream|vehicle cream applied twice daily for 4 weeks
397291|NCT00476151|P2|Participant Flow|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
397292|NCT00476151|P1|Participant Flow|Placebo Cream|vehicle cream applied twice daily for 4 weeks
397293|NCT00476151|O2|Outcome|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
397294|NCT00476151|O1|Outcome|Placebo Cream|vehicle cream applied twice daily for 4 weeks
397295|NCT00476151|E2|Reported Event|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
397296|NCT00476151|E1|Reported Event|Placebo Cream|vehicle cream applied twice daily for 4 weeks
397297|NCT00476229|B1|Baseline|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
397298|NCT00476229|P1|Participant Flow|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
397299|NCT00476229|O1|Outcome|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
397300|NCT00476229|E1|Reported Event|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
397301|NCT00476242|B3|Baseline|Total|Total of all reporting groups
397302|NCT00476242|B2|Baseline|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo
Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
397303|NCT00476242|B1|Baseline|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)
Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
397304|NCT00476242|P2|Participant Flow|Memantine and Vivitrol|Participants treated with memantine 40 mg/d capsules and Vivitrol.
397305|NCT00476242|P1|Participant Flow|Placebo and Vivitrol|Participants treated with placebo capsules and Vivitrol.
397306|NCT00476242|O2|Outcome|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo
Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
397307|NCT00476242|O1|Outcome|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)
Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
397308|NCT00476242|O2|Outcome|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo
Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
397309|NCT00476242|O1|Outcome|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)
Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
397310|NCT00476242|E2|Reported Event|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo
Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
397342|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
397385|NCT00477165|E1|Reported Event|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
397311|NCT00476242|E1|Reported Event|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)
Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
397312|NCT00476827|B7|Baseline|Total|Total of all reporting groups
397313|NCT00476827|B6|Baseline|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
397314|NCT00476827|B5|Baseline|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
397315|NCT00476827|B4|Baseline|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397316|NCT00476827|B3|Baseline|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397317|NCT00476827|B2|Baseline|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397318|NCT00476827|B1|Baseline|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
397319|NCT00476827|P6|Participant Flow|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
397320|NCT00476827|P5|Participant Flow|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
397321|NCT00476827|P4|Participant Flow|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397322|NCT00476827|P3|Participant Flow|Bevacizumab / Irinotecan (Camptosar®, CPT-11)|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397323|NCT00476827|P2|Participant Flow|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397324|NCT00476827|P1|Participant Flow|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
397325|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
397326|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
397327|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397328|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397329|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397330|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
397331|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
397332|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
397333|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397334|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397335|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397336|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
397337|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
397338|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
397339|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397340|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397341|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397383|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
397343|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
397344|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
397345|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397346|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397347|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
397348|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
397349|NCT00476827|E4|Reported Event|Avastin (Bevacizumab)/Navelbine (Vinorelbine Tartrate)|
397350|NCT00476827|E3|Reported Event|Avastin (Bevacizumab)/Gemzar(Gemcitabine,Difluorodeoxycytidine|
397351|NCT00476827|E2|Reported Event|Avastin (Bevacizumab) / Camptosar (CPT 11/ Irinotecan)|
397352|NCT00476827|E1|Reported Event|Avastin (Bevacizumab)/ Capecitabine (Xeloda)|
397353|NCT00476957|B3|Baseline|Total|Total of all reporting groups
397354|NCT00476957|B2|Baseline|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent
Stent : Stent implantation"
397355|NCT00476957|B1|Baseline|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Stent : Stent implantation"
397356|NCT00476957|P2|Participant Flow|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent
Stent : Stent implantation"
397357|NCT00476957|P1|Participant Flow|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Stent : Stent implantation"
397358|NCT00476957|O2|Outcome|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent
Stent : Stent implantation"
397359|NCT00476957|O1|Outcome|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Stent : Stent implantation"
397360|NCT00476957|O2|Outcome|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent
Stent : Stent implantation"
397361|NCT00476957|O1|Outcome|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Stent : Stent implantation"
397362|NCT00476957|E2|Reported Event|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent
Stent : Stent implantation"
397363|NCT00476957|E1|Reported Event|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Stent : Stent implantation"
397364|NCT00477152|B1|Baseline|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
397365|NCT00477152|P1|Participant Flow|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
397366|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
397367|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
397368|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
397369|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
397370|NCT00477152|E1|Reported Event|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
397371|NCT00477165|B3|Baseline|Total|Total of all reporting groups
397372|NCT00477165|B2|Baseline|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
397373|NCT00477165|B1|Baseline|Cialopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
397374|NCT00477165|P2|Participant Flow|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
397375|NCT00477165|P1|Participant Flow|Cialopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
397376|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
397377|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
397378|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
397379|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
397380|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
397381|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
397382|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
397384|NCT00477165|E2|Reported Event|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
453730|NCT00619970|O1|Outcome|Healthy Control|Healthy controls
397386|NCT00477191|B1|Baseline|Etanercept|"Etanercept
Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and then 50 mg once a week for 3 months."
397387|NCT00477191|P1|Participant Flow|Etanercept|"Etanercept
Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
397388|NCT00477191|O1|Outcome|Etanercept|"Etanercept
Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
397389|NCT00477191|O1|Outcome|Etanercept|"Etanercept
Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
397390|NCT00477191|O1|Outcome|Etanercept|"Etanercept
Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
397391|NCT00477191|O1|Outcome|Etanercept|"Etanercept
Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
397392|NCT00477191|E1|Reported Event|Etanercept|"Etanercept
Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
397393|NCT00477204|B3|Baseline|Total|Total of all reporting groups
397394|NCT00477204|B2|Baseline|Zocor|simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication
397395|NCT00477204|B1|Baseline|Vytorin|simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication
397396|NCT00477204|P2|Participant Flow|Simvastatin|"simvastatin: simvastatin 20 mg daily
placebo for each medication"
397397|NCT00477204|P1|Participant Flow|Ezetimibe/Simvastatin|ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication
397398|NCT00477204|O2|Outcome|Zocor (Simvastatin)|"simvastatin: simvastatin 20 mg daily
placebo for each medication"
397399|NCT00477204|O1|Outcome|Vytorin (Ezetimibe/Simvastatin)|ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication
397400|NCT00477204|E2|Reported Event|Zocor [Simvastatin]|Zocor [simvastatin] 20 mg taken daily for 6 months to compare in a 2- arm design to Vytorin [simvastatin + ezetimibe].
397401|NCT00477204|E1|Reported Event|Vytorin (Simvastatin + Ezetimibe)|Vytorin [simvastatin + ezetimibe]20 mg taken daily for 6 months to compare in a 2- arm design to Zocor [simvastatin] .
397402|NCT00477230|B3|Baseline|Total|Total of all reporting groups
397403|NCT00477230|B2|Baseline|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
397404|NCT00477230|B1|Baseline|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
397405|NCT00477230|P2|Participant Flow|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
397406|NCT00477230|P1|Participant Flow|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
397407|NCT00477230|O2|Outcome|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
397408|NCT00477230|O1|Outcome|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
397409|NCT00477230|E2|Reported Event|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
397410|NCT00477230|E1|Reported Event|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
397411|NCT00477269|B3|Baseline|Total|Total of all reporting groups
397412|NCT00477269|B2|Baseline|Placebo|Placebo
397413|NCT00477269|B1|Baseline|STI571|STI571
397414|NCT00477269|P3|Participant Flow|All Patients|Open label extension
397415|NCT00477269|P2|Participant Flow|Placebo|Placebo
397416|NCT00477269|P1|Participant Flow|STI571|STI571
397417|NCT00477269|O2|Outcome|Placebo|Placebo
397418|NCT00477269|O1|Outcome|STI571|STI571
397419|NCT00477269|O2|Outcome|Placebo|Placebo
397420|NCT00477269|O1|Outcome|STI571|STI571
397421|NCT00477269|O2|Outcome|Placebo|Placebo
397422|NCT00477269|O1|Outcome|STI571|STI571
397423|NCT00477269|O2|Outcome|Placebo|Placebo
397424|NCT00477269|O1|Outcome|STI571|STI571
397425|NCT00477269|O2|Outcome|Placebo|Placebo
397426|NCT00477269|O1|Outcome|STI571|STI571
397427|NCT00477269|O2|Outcome|Placebo|Placebo
397428|NCT00477269|O1|Outcome|STI571|STI571
397429|NCT00477269|O2|Outcome|Placebo|Placebo
397430|NCT00477269|O1|Outcome|STI571|STI571
397431|NCT00477269|O2|Outcome|Placebo|Placebo
397432|NCT00477269|O1|Outcome|STI571|STI571
397433|NCT00477269|O2|Outcome|Placebo|Placebo
397434|NCT00477269|O1|Outcome|STI571|STI571
397435|NCT00477269|O2|Outcome|Placebo|Placebo
397436|NCT00477269|O1|Outcome|STI571|STI571
397437|NCT00477269|O2|Outcome|Placebo|Placebo
397438|NCT00477269|O1|Outcome|STI571|STI571
397439|NCT00477269|O2|Outcome|Placebo|Placebo
397440|NCT00477269|O1|Outcome|STI571|STI571
397441|NCT00477269|O2|Outcome|Placebo|Placebo
397442|NCT00477269|O1|Outcome|STI571|STI571
397443|NCT00477269|O2|Outcome|Placebo|Placebo
397444|NCT00477269|O1|Outcome|STI571|STI571
397445|NCT00477269|O2|Outcome|Placebo|Placebo
397446|NCT00477269|O1|Outcome|STI571|STI571
397447|NCT00477269|O2|Outcome|Placebo|Placebo
397448|NCT00477269|O1|Outcome|STI571|STI571
397449|NCT00477269|O2|Outcome|Placebo|Placebo
397450|NCT00477269|O1|Outcome|STI571|STI571
397451|NCT00477269|O2|Outcome|Placebo|Placebo
397452|NCT00477269|O1|Outcome|STI571|STI571
397453|NCT00477269|O2|Outcome|Placebo|Placebo
397454|NCT00477269|O1|Outcome|STI571|STI571
397455|NCT00477269|O2|Outcome|Placebo|Placebo
397456|NCT00477269|O1|Outcome|STI571|STI571
397457|NCT00477269|O2|Outcome|Placebo|Placebo
397557|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397468|NCT00477295|B2|Baseline|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397469|NCT00477295|B1|Baseline|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397470|NCT00477295|P2|Participant Flow|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397471|NCT00477295|P1|Participant Flow|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397472|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397473|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397474|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397475|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397476|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397477|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397478|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397479|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397717|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
423850|NCT00543725|E1|Reported Event|TMC278|25 mg tablet once daily
397480|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397481|NCT00477295|O1|Outcome|Zonisamide|"The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily.
During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP."
397482|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397483|NCT00477295|O1|Outcome|Zonisamide|"The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily.
During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP."
397484|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397485|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397486|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397487|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397488|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397489|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397490|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397491|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397533|NCT00477386|E1|Reported Event|Phase I Dosing Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
397492|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397493|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397494|NCT00477295|E2|Reported Event|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397495|NCT00477295|E1|Reported Event|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
397496|NCT00477334|B3|Baseline|Total|Total of all reporting groups
397497|NCT00477334|B2|Baseline|Placebo Comparator|Placebo twice a day for one day for treatment.
397498|NCT00477334|B1|Baseline|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
397499|NCT00477334|P2|Participant Flow|Placebo Comparator|Placebo twice a day for one day for treatment.
397500|NCT00477334|P1|Participant Flow|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
397501|NCT00477334|O4|Outcome|Grade 4 Toxicity|
397502|NCT00477334|O3|Outcome|Grade 3 Toxicity|
397503|NCT00477334|O2|Outcome|Grade 2 Toxicity|
397504|NCT00477334|O1|Outcome|Grade 1 Toxicity|
397505|NCT00477334|O4|Outcome|Grade 4 Toxicity|
397506|NCT00477334|O3|Outcome|Grade 3 Toxicity|
397507|NCT00477334|O2|Outcome|Grade 2 Toxicity|
397508|NCT00477334|O1|Outcome|Grade 1 Toxicity|
397509|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
397510|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
397511|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
397512|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
397513|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
397514|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
397515|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
397516|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
397517|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
397518|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
397519|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
397520|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
397521|NCT00477334|E2|Reported Event|Placebo Comparator|Placebo twice a day for one day for treatment.
397522|NCT00477334|E1|Reported Event|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
397523|NCT00477386|B3|Baseline|Total|Total of all reporting groups
397524|NCT00477386|B2|Baseline|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
397525|NCT00477386|B1|Baseline|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
397526|NCT00477386|P2|Participant Flow|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
397527|NCT00477386|P1|Participant Flow|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
397528|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
397529|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
397530|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
397531|NCT00477386|O1|Outcome|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
397532|NCT00477386|E2|Reported Event|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
397534|NCT00477451|B5|Baseline|Total|Total of all reporting groups
397535|NCT00477451|B4|Baseline|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment
Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397536|NCT00477451|B3|Baseline|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397537|NCT00477451|B2|Baseline|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397538|NCT00477451|B1|Baseline|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397539|NCT00477451|P4|Participant Flow|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment
Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397540|NCT00477451|P3|Participant Flow|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397541|NCT00477451|P2|Participant Flow|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397542|NCT00477451|P1|Participant Flow|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397543|NCT00477451|O2|Outcome|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397544|NCT00477451|O1|Outcome|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397545|NCT00477451|O2|Outcome|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397546|NCT00477451|O1|Outcome|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397547|NCT00477451|O2|Outcome|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397548|NCT00477451|O1|Outcome|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397549|NCT00477451|E4|Reported Event|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment
Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397550|NCT00477451|E3|Reported Event|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397551|NCT00477451|E2|Reported Event|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397552|NCT00477451|E1|Reported Event|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
Inhaled placebo: Inhaled Staccato Alprazolam Placebo
IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
397553|NCT00477464|B1|Baseline|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
397554|NCT00477464|P1|Participant Flow|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
397555|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397556|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397685|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397812|NCT00478023|E5|Reported Event|Placebo|Matched Placebo 4 to 6 hourly
397558|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397559|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397560|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|
397561|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397562|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397563|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397564|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397565|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397566|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397567|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397568|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397569|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397570|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397571|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397572|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397573|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
397574|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
397575|NCT00477464|E1|Reported Event|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
397576|NCT00477490|B6|Baseline|Total|Total of all reporting groups
397577|NCT00477490|B5|Baseline|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397578|NCT00477490|B4|Baseline|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397579|NCT00477490|B3|Baseline|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397580|NCT00477490|B2|Baseline|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397581|NCT00477490|B1|Baseline|Placebo|Participants took a placebo ‘melt’ for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
397582|NCT00477490|P9|Participant Flow|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
454702|NCT00621959|O1|Outcome|Placebo|Matched placebo tablets once daily
397583|NCT00477490|P8|Participant Flow|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
397584|NCT00477490|P7|Participant Flow|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
397585|NCT00477490|P6|Participant Flow|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
397586|NCT00477490|P5|Participant Flow|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397587|NCT00477490|P4|Participant Flow|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397588|NCT00477490|P3|Participant Flow|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397589|NCT00477490|P2|Participant Flow|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397590|NCT00477490|P1|Participant Flow|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397591|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
397592|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
397593|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
397594|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
397595|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397596|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397597|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397598|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397599|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397600|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397601|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397602|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397603|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
397604|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397605|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397606|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397607|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397608|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
397609|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397610|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397611|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397612|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397613|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
397614|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397615|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397616|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397617|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397618|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
397619|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397620|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397621|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397622|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397623|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
397624|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397625|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397626|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397627|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397628|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
397629|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397630|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397813|NCT00478023|E4|Reported Event|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
397631|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397632|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397633|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
397634|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
397635|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
397636|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
397637|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
397638|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397639|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397640|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397641|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397642|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
397643|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
397644|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
397645|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
397646|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397647|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397648|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397649|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397650|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397651|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397652|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397653|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397654|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
397655|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
423851|NCT00543764|B3|Baseline|Total|Total of all reporting groups
397656|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397657|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397658|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397659|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
397660|NCT00477490|E13|Reported Event|Part II: Placebo to Desmopressin Melt 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
397661|NCT00477490|E12|Reported Event|Part II: Placebo to Desmopressin Melt 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
397662|NCT00477490|E11|Reported Event|Part II: Placebo to Desmopressin Melt 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
397663|NCT00477490|E10|Reported Event|Part II: Placebo to Desmopressin Melt 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime
397664|NCT00477490|E9|Reported Event|Part II: Desmopressin Melt 100 μg|Participants who took desmopressin melt 100 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
397665|NCT00477490|E8|Reported Event|Part II: Desmopressin Melt 50 μg|Participants who took desmopressin melt 50 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
397666|NCT00477490|E7|Reported Event|Part II: Desmopressin Melt 25 μg|Participants who took desmopressin melt 25 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
397667|NCT00477490|E6|Reported Event|Part II: Desmopressin Melt 10 μg|Participants who took desmopressin melt 10 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
397668|NCT00477490|E5|Reported Event|Part I: Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
397669|NCT00477490|E4|Reported Event|Part I: Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study.
397670|NCT00477490|E3|Reported Event|Part I: Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study.
397671|NCT00477490|E2|Reported Event|Part I: Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study.
397672|NCT00477490|E1|Reported Event|Part I: Placebo|Participants took a placebo ‘melt’ for 28 days to complete Part I of the study.
397673|NCT00477594|B3|Baseline|Total|Total of all reporting groups
397674|NCT00477594|B2|Baseline|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397675|NCT00477594|B1|Baseline|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397676|NCT00477594|P2|Participant Flow|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397677|NCT00477594|P1|Participant Flow|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397678|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397679|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397680|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397681|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397682|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397683|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397684|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397686|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397687|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397688|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397689|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397690|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397691|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397692|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397693|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397694|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397695|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397696|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397697|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397698|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397699|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397700|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397701|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397702|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397703|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397704|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397705|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397706|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397707|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397708|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397709|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397710|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397711|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397712|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397713|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397714|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397715|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397716|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397718|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397719|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397720|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397721|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397722|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397723|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397724|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397725|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397726|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397727|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397728|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397729|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397730|NCT00477594|E2|Reported Event|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
397731|NCT00477594|E1|Reported Event|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
397732|NCT00477607|B3|Baseline|Total|Total of all reporting groups
397733|NCT00477607|B2|Baseline|Arm 2|"Receiving placebo during cisplatin treatment
Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.
alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
397734|NCT00477607|B1|Baseline|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.
laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.
alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
397735|NCT00477607|P2|Participant Flow|Placebo|"Receiving placebo during cisplatin treatment
Placebo supplements (1200mg once a day) were administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment."
397736|NCT00477607|P1|Participant Flow|Alpha-lipoic Acid|"Receiving alpha-lipoic acid during cisplatin treatment.
alpha-lipoic acid : Supplements (1200mg once a day) was administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment."
397737|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment
Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.
alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
397738|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.
laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.
alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
397739|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment
Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.
alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
397740|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.
laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.
alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
397814|NCT00478023|E3|Reported Event|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
397815|NCT00478023|E2|Reported Event|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
397820|NCT00478036|B1|Baseline|Placebo Group|Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
397821|NCT00478036|P3|Participant Flow|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
Refresh Tears: Placebo"
397741|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment
Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.
alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
397742|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.
laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.
alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
397743|NCT00477607|E2|Reported Event|Arm 2|"Receiving placebo during cisplatin treatment
Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.
alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
397744|NCT00477607|E1|Reported Event|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.
laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.
alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
397745|NCT00477633|B1|Baseline|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
397746|NCT00477633|P1|Participant Flow|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
397747|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
397748|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
397749|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
397750|NCT00477633|E1|Reported Event|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
397751|NCT00477672|B4|Baseline|Total|Total of all reporting groups
397752|NCT00477672|B3|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
397753|NCT00477672|B2|Baseline|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
397754|NCT00477672|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
397755|NCT00477672|P3|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
397756|NCT00477672|P2|Participant Flow|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
397757|NCT00477672|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
397758|NCT00477672|O3|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
397759|NCT00477672|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
397760|NCT00477672|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
397761|NCT00477672|O3|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
397762|NCT00477672|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
397763|NCT00477672|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
397764|NCT00477672|E3|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
397765|NCT00477672|E2|Reported Event|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
397766|NCT00477672|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
397767|NCT00477685|B1|Baseline|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
397768|NCT00477685|P1|Participant Flow|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
397769|NCT00477685|O1|Outcome|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
397770|NCT00477685|O1|Outcome|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
397771|NCT00477685|E1|Reported Event|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
397772|NCT00477750|B1|Baseline|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression
Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression
Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
397773|NCT00477750|P1|Participant Flow|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression
Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression
Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
397774|NCT00477750|O1|Outcome|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression > > Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression >
> Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
397816|NCT00478023|E1|Reported Event|Morphine|Morphine IR 20mg 4-6 hourly
397775|NCT00477750|E1|Reported Event|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression
Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression
Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
397776|NCT00477971|B3|Baseline|Total|Total of all reporting groups
397777|NCT00477971|B2|Baseline|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
397778|NCT00477971|B1|Baseline|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
397779|NCT00477971|P2|Participant Flow|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
397780|NCT00477971|P1|Participant Flow|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
397781|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
397782|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
397783|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
397784|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
397785|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
397786|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
397787|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
397788|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
397789|NCT00477971|E2|Reported Event|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
397790|NCT00477971|E1|Reported Event|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
397791|NCT00478023|B6|Baseline|Total|Total of all reporting groups
397792|NCT00478023|B5|Baseline|Placebo|Matched Placebo 4 to 6 hourly
397793|NCT00478023|B4|Baseline|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
397794|NCT00478023|B3|Baseline|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
397795|NCT00478023|B2|Baseline|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
397796|NCT00478023|B1|Baseline|Morphine|Morphine IR 20mg 4-6 hourly
397797|NCT00478023|P5|Participant Flow|Placebo|Matched Placebo 4 to 6 hourly
397798|NCT00478023|P4|Participant Flow|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
397799|NCT00478023|P3|Participant Flow|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
397800|NCT00478023|P2|Participant Flow|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
397801|NCT00478023|P1|Participant Flow|Morphine|Morphine IR 20mg 4-6 hourly
397802|NCT00478023|O5|Outcome|Placebo|Matched Placebo 4 to 6 hourly
397803|NCT00478023|O4|Outcome|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
397804|NCT00478023|O3|Outcome|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
397805|NCT00478023|O2|Outcome|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
397806|NCT00478023|O1|Outcome|Morphine|Morphine IR 20mg 4-6 hourly
397807|NCT00478023|O5|Outcome|Placebo|Matched Placebo 4 to 6 hourly
397808|NCT00478023|O4|Outcome|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
397809|NCT00478023|O3|Outcome|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
397810|NCT00478023|O2|Outcome|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
397811|NCT00478023|O1|Outcome|Morphine|Morphine IR 20mg 4-6 hourly
397822|NCT00478036|P2|Participant Flow|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days
Pred Forte: Details covered in arm description"
397823|NCT00478036|P1|Participant Flow|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days
Acular LS: Details covered in arm description"
397824|NCT00478036|O3|Outcome|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
Refresh Tears: Placebo"
397825|NCT00478036|O2|Outcome|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days
Pred Forte: Details covered in arm description"
397826|NCT00478036|O1|Outcome|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days
Acular LS: Details covered in arm description"
397827|NCT00478036|E3|Reported Event|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
Refresh Tears: Placebo"
397828|NCT00478036|E2|Reported Event|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days
Pred Forte: Details covered in arm description"
397829|NCT00478036|E1|Reported Event|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days
Acular LS: Details covered in arm description"
397830|NCT00478140|B1|Baseline|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
397831|NCT00478140|P1|Participant Flow|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
397832|NCT00478140|O1|Outcome|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
397833|NCT00478140|E1|Reported Event|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
397834|NCT00478192|B4|Baseline|Total|Total of all reporting groups
397835|NCT00478192|B3|Baseline|Regimen 3 Placebo|
397836|NCT00478192|B2|Baseline|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
397837|NCT00478192|B1|Baseline|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
397838|NCT00478192|P3|Participant Flow|Regimen 3 Placebo|
397839|NCT00478192|P2|Participant Flow|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
397840|NCT00478192|P1|Participant Flow|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
397841|NCT00478192|O3|Outcome|Regimen 3 Placebo|
397842|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
397843|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
397844|NCT00478192|O3|Outcome|Regimen 3 Placebo|
397845|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
397846|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
397847|NCT00478192|O3|Outcome|Regimen 3 Placebo|
397848|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
397849|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
397850|NCT00478192|O3|Outcome|Regimen 3 Placebo|
397851|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
397852|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
397853|NCT00478192|O3|Outcome|Regimen 3 Placebo|
397854|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
397855|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
397856|NCT00478192|O1|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
397857|NCT00478192|O3|Outcome|Regimen 3 Placebo|
397858|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
397859|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
397860|NCT00478192|O3|Outcome|Regimen 3 Placebo|
397861|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
397862|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
397863|NCT00478192|E3|Reported Event|Regimen 3 Placebo|
397864|NCT00478192|E2|Reported Event|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
397865|NCT00478192|E1|Reported Event|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
397866|NCT00478205|B3|Baseline|Total|Total of all reporting groups
397867|NCT00478205|B2|Baseline|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
397868|NCT00478205|B1|Baseline|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
397869|NCT00478205|P2|Participant Flow|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
397870|NCT00478205|P1|Participant Flow|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
397871|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
397872|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
398032|NCT00479089|B1|Baseline|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
397873|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
397874|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
397875|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
397876|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
397877|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
397878|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
397879|NCT00478205|E2|Reported Event|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
397880|NCT00478205|E1|Reported Event|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
397881|NCT00478218|B3|Baseline|Total|Total of all reporting groups
397882|NCT00478218|B2|Baseline|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397883|NCT00478218|B1|Baseline|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397884|NCT00478218|P2|Participant Flow|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397885|NCT00478218|P1|Participant Flow|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397886|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397887|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397888|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397889|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397890|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397891|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397892|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397893|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397894|NCT00478218|E2|Reported Event|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397895|NCT00478218|E1|Reported Event|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
397896|NCT00478231|B1|Baseline|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397897|NCT00478231|P1|Participant Flow|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397898|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397899|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397900|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397901|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397902|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397903|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397904|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397905|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
398211|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
397948|NCT00478569|B1|Baseline|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
397906|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397907|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397908|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397909|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397910|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397911|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397912|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397913|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397914|NCT00478231|E1|Reported Event|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
397915|NCT00478244|B1|Baseline|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
397916|NCT00478244|P1|Participant Flow|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
397917|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
397918|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
397919|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
397920|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
397921|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
397922|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
397923|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
397924|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
397925|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
397926|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
397927|NCT00478244|E1|Reported Event|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
397928|NCT00478257|B3|Baseline|Total|Total of all reporting groups
397929|NCT00478257|B2|Baseline|Effect of Red Light|effect of red light on fatigue in women with breast cancer
397930|NCT00478257|B1|Baseline|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
397931|NCT00478257|P2|Participant Flow|Effect of Red Light|effect of red light on fatigue in women with breast cancer
397932|NCT00478257|P1|Participant Flow|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
397933|NCT00478257|O2|Outcome|Effect of Red Light|effect of red light on fatigue in women with breast cancer
397934|NCT00478257|O1|Outcome|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
397935|NCT00478257|E2|Reported Event|Effect of Red Light|effect of red light on fatigue in women with breast cancer
397936|NCT00478257|E1|Reported Event|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
397937|NCT00478556|B3|Baseline|Total|Total of all reporting groups
397938|NCT00478556|B2|Baseline|Omnipaque|Oral Omnipaque prior to CT
397939|NCT00478556|B1|Baseline|Gastroview|Oral Gastroview prior to CT
397940|NCT00478556|P2|Participant Flow|Omnipaque Group|Patients ill be given oral Omnipaque (contrast) prior to Computerized Tomography (CT).
397941|NCT00478556|P1|Participant Flow|Gastroview Group|Patients will be given oral Gastroview (contrast) prior to Computerized Tomography (CT).
397942|NCT00478556|O2|Outcome|Omnipaque|Oral Omnipaque prior to CT
397943|NCT00478556|O1|Outcome|Gastroview|Oral Gastroview prior to CT
397944|NCT00478556|O2|Outcome|Omnipaque|Oral Omnipaque prior to CT
397945|NCT00478556|O1|Outcome|Gastroview|Oral Gastroview prior to CT
397946|NCT00478556|E2|Reported Event|Omnipaque|Oral Omnipaque prior to CT
397947|NCT00478556|E1|Reported Event|Gastroview|Oral Gastroview prior to CT
397949|NCT00478569|P1|Participant Flow|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
397950|NCT00478569|O5|Outcome|24 Months|
397951|NCT00478569|O4|Outcome|18 Months|
397952|NCT00478569|O3|Outcome|12 Months|
397953|NCT00478569|O2|Outcome|6 Months|
397954|NCT00478569|O1|Outcome|3 Months|
397955|NCT00478569|O1|Outcome|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
397956|NCT00478569|O4|Outcome|24 Months|
397957|NCT00478569|O3|Outcome|18 Months|
397958|NCT00478569|O2|Outcome|12 Months|
397959|NCT00478569|O1|Outcome|3 Months|
397960|NCT00478569|O1|Outcome|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
397961|NCT00478569|E1|Reported Event|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
397962|NCT00478608|B1|Baseline|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
397963|NCT00478608|P1|Participant Flow|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
397964|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
397965|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
397966|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
397967|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
398216|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398217|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
397968|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
397969|NCT00478608|E1|Reported Event|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.
On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.
CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.
Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
397970|NCT00478647|B1|Baseline|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
397971|NCT00478647|P1|Participant Flow|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
397972|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
397973|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
397974|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
397975|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
397976|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
397977|NCT00478647|E1|Reported Event|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
397978|NCT00478673|B1|Baseline|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
397979|NCT00478673|P1|Participant Flow|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
397980|NCT00478673|O1|Outcome|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
397981|NCT00478673|O1|Outcome|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
397982|NCT00478673|E1|Reported Event|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
397983|NCT00478777|B1|Baseline|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
397984|NCT00478777|P1|Participant Flow|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
397985|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
397986|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
397987|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
397988|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
397989|NCT00478777|E1|Reported Event|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
397990|NCT00478881|B3|Baseline|Total|Total of all reporting groups
397991|NCT00478881|B2|Baseline|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
397992|NCT00478881|B1|Baseline|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
397993|NCT00478881|P2|Participant Flow|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
397994|NCT00478881|P1|Participant Flow|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
397995|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
397996|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
397997|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
397998|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
397999|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
398000|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
398001|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
398002|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
398003|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
398004|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
398005|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
398006|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
398007|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
398008|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
398009|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
398010|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
398011|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
398012|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
398013|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
398014|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
398015|NCT00478881|E2|Reported Event|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
398016|NCT00478881|E1|Reported Event|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
398017|NCT00479037|B3|Baseline|Total|Total of all reporting groups
398018|NCT00479037|B2|Baseline|Strontium Ranelate|One sachet (2 g) per day, suspended in water
398019|NCT00479037|B1|Baseline|PTH(1-84)|Once daily subcutaneous injection
398020|NCT00479037|P2|Participant Flow|Strontium Ranelate|One sachet (2 g) per day, suspended in water
398021|NCT00479037|P1|Participant Flow|PTH(1-84)|Once daily subcutaneous injection
398022|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
398023|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
398024|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
398025|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
398026|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
398027|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
398028|NCT00479037|E2|Reported Event|Strontium Ranelate|One sachet (2 g) per day, suspended in water
398029|NCT00479037|E1|Reported Event|PTH(1-84)|Once daily subcutaneous injection
398030|NCT00479089|B3|Baseline|Total|Total of all reporting groups
398031|NCT00479089|B2|Baseline|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
398212|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398033|NCT00479089|P2|Participant Flow|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
398034|NCT00479089|P1|Participant Flow|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
398035|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
398036|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
398037|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
398038|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
398039|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
398040|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
398041|NCT00479089|E2|Reported Event|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
398042|NCT00479089|E1|Reported Event|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
398043|NCT00479154|B3|Baseline|Total|Total of all reporting groups
398044|NCT00479154|B2|Baseline|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
398045|NCT00479154|B1|Baseline|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
398046|NCT00479154|P2|Participant Flow|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
398047|NCT00479154|P1|Participant Flow|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
398048|NCT00479154|O2|Outcome|Botulinum Toxin|Injection of Botulinum Toxin (90 mU per leg).
398049|NCT00479154|O1|Outcome|Placebo|Injection into set of leg muscles with Placebo.
398050|NCT00479154|E2|Reported Event|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
398051|NCT00479154|E1|Reported Event|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
398052|NCT00479232|B3|Baseline|Total|Total of all reporting groups
398053|NCT00479232|B2|Baseline|Vorinostat + Decitabine, Sequential|(sequential) Vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
398054|NCT00479232|B1|Baseline|Vorinostat + Decitabine, Concurrent|(concurrent) Vorinostat 400 mg capsules once daily given 7 days, 14 days with 8 day break after first 7 days or 14 days without break, out of 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
398055|NCT00479232|P6|Participant Flow|Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398056|NCT00479232|P5|Participant Flow|Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398057|NCT00479232|P4|Participant Flow|Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398058|NCT00479232|P3|Participant Flow|Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398059|NCT00479232|P2|Participant Flow|Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398060|NCT00479232|P1|Participant Flow|Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily (qd) on Days 1 to 7 in a 28 day cycle, along with decitabine intravenous (IV) 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398061|NCT00479232|O2|Outcome|Untreated AML or Intermediate, Sequential|"Participants with Untreated AML or Intermediate-High
Risk MDS who were treated with vorinostat and Decitabine
sequentially."
398062|NCT00479232|O1|Outcome|Untreated AML or Intermediate, Concurrent|"Participants with Untreated AML or Intermediate-High
Risk MDS who were treated with vorinostat and Decitabine
concurrently."
398063|NCT00479232|O2|Outcome|Refractory or Relapsed AML, Sequential|Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine sequentially.
398064|NCT00479232|O1|Outcome|Refractory or Relapsed AML, Concurrent|Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine concurrently.
398065|NCT00479232|O6|Outcome|Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398066|NCT00479232|O5|Outcome|Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398213|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398067|NCT00479232|O4|Outcome|Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398068|NCT00479232|O3|Outcome|Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398069|NCT00479232|O2|Outcome|Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398070|NCT00479232|O1|Outcome|Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398071|NCT00479232|E6|Reported Event|Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)|(sequential) orinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398072|NCT00479232|E5|Reported Event|Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398073|NCT00479232|E4|Reported Event|Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398074|NCT00479232|E3|Reported Event|Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398075|NCT00479232|E2|Reported Event|Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398076|NCT00479232|E1|Reported Event|Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
398077|NCT00479258|B3|Baseline|Total|Total of all reporting groups
398078|NCT00479258|B2|Baseline|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
398079|NCT00479258|B1|Baseline|Inhaled Insulin (Exubera)|No subjects received study medication.
398080|NCT00479258|P2|Participant Flow|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
398081|NCT00479258|P1|Participant Flow|Inhaled Insulin (Exubera)|No subjects received study medication.
398082|NCT00479258|O2|Outcome|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
398083|NCT00479258|O1|Outcome|Inhaled Insulin (Exubera)|No subjects received study medication.
398084|NCT00479336|B5|Baseline|Total|Total of all reporting groups
398085|NCT00479336|B4|Baseline|OPC-41061 30 mg|30 mg, 1 tablet a day
398086|NCT00479336|B3|Baseline|OPC-41061 15 mg|15 mg, 1 tablet a day
398087|NCT00479336|B2|Baseline|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
398088|NCT00479336|B1|Baseline|Placebo|Placebo, 1 tablet a day
398089|NCT00479336|P4|Participant Flow|OPC-41061 30 mg|30 mg, 1 tablet a day
398090|NCT00479336|P3|Participant Flow|OPC-41061 15 mg|15 mg, 1 tablet a day
398091|NCT00479336|P2|Participant Flow|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
398092|NCT00479336|P1|Participant Flow|Placebo|Placebo, 1 tablet a day
398093|NCT00479336|O4|Outcome|OPC-41061 30 mg|30 mg, 1 tablet a day
398094|NCT00479336|O3|Outcome|OPC-41061 15 mg|15 mg, 1 tablet a day
398095|NCT00479336|O2|Outcome|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
398096|NCT00479336|O1|Outcome|Placebo|Placebo, 1 tablet a day
398097|NCT00479336|O4|Outcome|OPC-41061 30 mg|30 mg, 1 tablet a day
398098|NCT00479336|O3|Outcome|OPC-41061 15 mg|15 mg, 1 tablet a day
398099|NCT00479336|O2|Outcome|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
398100|NCT00479336|O1|Outcome|Placebo|Placebo, 1 tablet a day
398101|NCT00479336|E4|Reported Event|OPC-41061 30 mg|30 mg, 1 tablet a day
398102|NCT00479336|E3|Reported Event|OPC-41061 15 mg|15 mg, 1 tablet a day
398103|NCT00479336|E2|Reported Event|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
398104|NCT00479336|E1|Reported Event|Placebo|Placebo, 1 tablet a day
398105|NCT00465569|B3|Baseline|Total|Total of all reporting groups
398106|NCT00465569|B2|Baseline|Placebo|Placebo
398107|NCT00465569|B1|Baseline|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians
cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
398108|NCT00465569|P2|Participant Flow|Placebo|Pre-measured doses of ProFree, a dry, milk free powder
398109|NCT00465569|P1|Participant Flow|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians
cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
398110|NCT00465569|O2|Outcome|Placebo|Placebo
398111|NCT00465569|O1|Outcome|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians
cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
398112|NCT00465569|O2|Outcome|Placebo|Placebo
398113|NCT00465569|O1|Outcome|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians
cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
398114|NCT00465569|O2|Outcome|Placebo|Placebo
398214|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398115|NCT00465569|O1|Outcome|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians
cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
398116|NCT00465569|E2|Reported Event|Placebo|Adverse event information is based on percentages of doses. There were 1193 total doses in the placebo arm with a median of 171 and a range of 152-199 per participant. There was a total of 7 participants in the placebo arm who were analyzed for the Adverse Events data reported below.
398117|NCT00465569|E1|Reported Event|Active Treatment|Adverse event information is based on percentages of doses. There were 2437 total doses in the active treatment arm with a median of 177 and a range of 155-242 per participant. There was a total of 13 participants in the active treatment arm who were analyzed for the Adverse Events data reported below.
398118|NCT00465647|B5|Baseline|Total|Total of all reporting groups
398119|NCT00465647|B4|Baseline|≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398120|NCT00465647|B3|Baseline|≥ 5 Years to < 12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398121|NCT00465647|B2|Baseline|≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398122|NCT00465647|B1|Baseline|≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398123|NCT00465647|P4|Participant Flow|≥ 12 Years to < 17 Years|Adolescent- received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398124|NCT00465647|P3|Participant Flow|≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398125|NCT00465647|P2|Participant Flow|≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398126|NCT00465647|P1|Participant Flow|≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398127|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398128|NCT00465647|O3|Outcome|Oral ≥ 5 Years to <12 Years|Older child (Data for this group not collected. Test not appropriate for this age)
398129|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child (Data for this group not collected. Test not appropriate for this age)
398130|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler (Data for this group not collected. Test not appropriate for this age)
398131|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent (Data for this group not collected. Test not appropriate for this age)
398132|NCT00465647|O3|Outcome|Oral ≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398133|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398134|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler (Data for this group not collected. Test not appropriate for this age)
398135|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent (Data for this group not collected. Test not appropriate for this age)
398136|NCT00465647|O3|Outcome|Oral ≥ 5 Years to < 12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398137|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398138|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398139|NCT00465647|O1|Outcome|All Patients|A total of all 4 age groups: infant and toddler, young child, older child, and adolescent.
398140|NCT00465647|E8|Reported Event|Parenteral ≥ 12 Years to < 17 Years|Adolescent - received parenteral analgesia up to 48 hours postsurgery.
398141|NCT00465647|E7|Reported Event|Parenteral ≥ 5 Years to < 12 Years|Older child - received parenteral analgesia up to 48 hours postsurgery.
398142|NCT00465647|E6|Reported Event|Parenteral ≥ 13 Months to < 5 Years|Young child - received parenteral analgesia up to 48 hours postsurgery.
398143|NCT00465647|E5|Reported Event|Parenteral ≥ 28 Days to < 13 Months|Infant and toddler - received parenteral analgesia up to 48 hours postsurgery.
398144|NCT00465647|E4|Reported Event|Oral ≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398145|NCT00465647|E3|Reported Event|Oral ≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398146|NCT00465647|E2|Reported Event|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398215|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398147|NCT00465647|E1|Reported Event|Oral ≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
398148|NCT00465738|B3|Baseline|Total|Total of all reporting groups
398149|NCT00465738|B2|Baseline|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398150|NCT00465738|B1|Baseline|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398151|NCT00465738|P2|Participant Flow|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398152|NCT00465738|P1|Participant Flow|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398153|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398154|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398155|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398156|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398157|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398158|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398159|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398160|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398161|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398162|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398163|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398164|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398165|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398166|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398167|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398168|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398169|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398170|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398171|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398172|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398173|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398174|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398175|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398176|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398177|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398178|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398179|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398180|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398181|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398182|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398183|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398184|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398185|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398186|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398187|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398188|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398189|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398190|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398191|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398192|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398193|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398194|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398195|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398196|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398197|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398198|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398199|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398200|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398201|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398202|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398203|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398204|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398205|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398206|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398207|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398208|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398209|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398210|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398218|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398219|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398220|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398221|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398222|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398223|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398224|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398225|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398226|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398227|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398228|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398229|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398230|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398231|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398232|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398233|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398234|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398235|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398236|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398237|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398238|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398239|NCT00465738|E2|Reported Event|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
398240|NCT00465738|E1|Reported Event|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
398241|NCT00465816|B4|Baseline|Total|Total of all reporting groups
398242|NCT00465816|B3|Baseline|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398243|NCT00465816|B2|Baseline|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398244|NCT00465816|B1|Baseline|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398245|NCT00465816|P3|Participant Flow|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398246|NCT00465816|P2|Participant Flow|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398247|NCT00465816|P1|Participant Flow|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398248|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398249|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398250|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398251|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398252|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398253|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398254|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398255|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398256|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398257|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398258|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398259|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398260|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398261|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398262|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398263|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398264|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398265|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398266|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398267|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398268|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398269|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398270|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398271|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398272|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
424193|NCT00545233|B3|Baseline|Total|Total of all reporting groups
398273|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
399030|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398274|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398275|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398276|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398277|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398278|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398279|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398280|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398281|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398282|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398283|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398284|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398285|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398286|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398287|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398288|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398289|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398290|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398291|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398292|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398293|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398294|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398295|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398296|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398297|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398298|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398299|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398300|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398301|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398302|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398303|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398304|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398305|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398306|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398307|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398308|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398309|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398310|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398311|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398312|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398313|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398314|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398315|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398316|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398317|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398318|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398319|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398320|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398321|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398322|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398323|NCT00465816|E3|Reported Event|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398324|NCT00465816|E2|Reported Event|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
398449|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398325|NCT00465816|E1|Reported Event|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
398326|NCT00465894|B3|Baseline|Total|Total of all reporting groups
398327|NCT00465894|B2|Baseline|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
398328|NCT00465894|B1|Baseline|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
398329|NCT00465894|P2|Participant Flow|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
398330|NCT00465894|P1|Participant Flow|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
398331|NCT00465894|O2|Outcome|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
398332|NCT00465894|O1|Outcome|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
398333|NCT00465894|E2|Reported Event|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
398334|NCT00465894|E1|Reported Event|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12-weeks
398335|NCT00465972|B3|Baseline|Total|Total of all reporting groups
398336|NCT00465972|B2|Baseline|Temazepam|1 15 mg pill taken nightly at bedtime.
398337|NCT00465972|B1|Baseline|Placebo|1 sugar pill taken nightly at bedtime.
398338|NCT00465972|P2|Participant Flow|Temazepam|One 15 mg temazepam pill taken orally at bedtime for the duration of the participant's involvement.
398339|NCT00465972|P1|Participant Flow|Placebo|One sugar pill taken orally at bedtime for duration of the participant's involvement.
398340|NCT00465972|O2|Outcome|Temazepam|1 15 mg pill taken nightly at bedtime.
398341|NCT00465972|O1|Outcome|Placebo|1 sugar taken nightly at bedtime.
398342|NCT00465972|O2|Outcome|Temazepam|1 15 mg pill of temazepam taken orally at bedtime.
398343|NCT00465972|O1|Outcome|Placebo|1 sugar pill taken orally at bedtime.
398344|NCT00465972|E2|Reported Event|Temazepam|1 15 mg pill taken orally, nightly, at bedtime.
398345|NCT00465972|E1|Reported Event|Placebo|1 sugar pill taken nightly at bedtime.
398346|NCT00465985|B1|Baseline|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398347|NCT00465985|P2|Participant Flow|Placebo|Placebo subcutaneous injection every 8 weeks.
398348|NCT00465985|P1|Participant Flow|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398349|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398350|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
398351|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398352|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398353|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
398354|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398355|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398356|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
398357|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398358|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
398359|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398360|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398361|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
398362|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398363|NCT00465985|E5|Reported Event|Entire Study ACZ885|Entire study ACZ885. The SAE and AEs were collected and reported for all three periods.
398364|NCT00465985|E4|Reported Event|Part III ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398365|NCT00465985|E3|Reported Event|Part II Placebo|Placebo subcutaneous injection every 8 weeks.
398366|NCT00465985|E2|Reported Event|Part II ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398367|NCT00465985|E1|Reported Event|Part I ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
398368|NCT00465998|B1|Baseline|Time From Induction to Delivery|Variables associated to time from induction to delivery were investigated.
398369|NCT00465998|P1|Participant Flow|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.
Variables associated to a successful vaginal delivery was examined."
398370|NCT00465998|O1|Outcome|Time From Induction to Delivery|Variables associated to time from induction to delivery were investigated.
398371|NCT00465998|O1|Outcome|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.
Variables associated to a successful vaginal delivery was examined."
398372|NCT00465998|E1|Reported Event|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.
Variables associated to a successful vaginal delivery was examined."
398373|NCT00466167|B4|Baseline|Total|Total of all reporting groups
398443|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398444|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
425695|NCT00548327|O2|Outcome|Patients With Schizophrenia|
398374|NCT00466167|B3|Baseline|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398375|NCT00466167|B2|Baseline|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398376|NCT00466167|B1|Baseline|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398377|NCT00466167|P3|Participant Flow|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398378|NCT00466167|P2|Participant Flow|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398379|NCT00466167|P1|Participant Flow|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398380|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398381|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398382|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398383|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398384|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398385|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398386|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398387|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398388|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398389|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398390|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398391|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398392|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398393|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398394|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398445|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398446|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
398395|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398396|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398397|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398398|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398399|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398400|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398401|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398402|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398403|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398404|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398405|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398406|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398407|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398408|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398409|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398410|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398411|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398412|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398413|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398414|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398415|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398447|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398448|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
425697|NCT00548327|O2|Outcome|Patients With Schizophrenia|
398416|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398417|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398418|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398419|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398420|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398421|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398422|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398423|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398424|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398425|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398426|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398427|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398428|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398429|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398430|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398431|NCT00466167|E3|Reported Event|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
398432|NCT00466167|E2|Reported Event|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
398433|NCT00466167|E1|Reported Event|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
398434|NCT00466193|B3|Baseline|Total|Total of all reporting groups
398435|NCT00466193|B2|Baseline|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398436|NCT00466193|B1|Baseline|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
398437|NCT00466193|P2|Participant Flow|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398438|NCT00466193|P1|Participant Flow|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
398439|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398440|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
398441|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398442|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
425850|NCT00542386|B2|Baseline|MCI-196: 6 g|MCI-196: 6 g/ day
398450|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
398451|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398452|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
398453|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398454|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
398455|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398456|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
398457|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398458|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
398459|NCT00466193|E2|Reported Event|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
398460|NCT00466193|E1|Reported Event|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
398461|NCT00466206|B1|Baseline|3MP Treatment Arm|Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
398462|NCT00466206|P1|Participant Flow|3MP Treatment Arm|Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
398463|NCT00466206|O1|Outcome|Magnetic Mini-Mover Group|Treatment for pectus excavatum using Magnimplant and Magnatract
398464|NCT00466206|O1|Outcome|3MP Treatment Arm|Pectus excavatum treated with Magnetic Mini-Mover Procedure. Active treatment = 18 months
398465|NCT00466206|O1|Outcome|3MP Treatment Group|Treatment of pectus excavatum with the Magnetic Mini-Mover Procedure
398466|NCT00466206|O1|Outcome|Treatment Arm|Magnetic Mini-Mover Procedure
398467|NCT00466206|O1|Outcome|Magnetic Mini-Mover Group|Treatment for pectus excavatum using Magnimplant and Magnatract
398468|NCT00466206|E1|Reported Event|Magnetic Mini-Mover Treatment|Use of the Magnimplant and Magnatract to treat pectus excavatum
398469|NCT00466310|B4|Baseline|Total|Total of all reporting groups
398470|NCT00466310|B3|Baseline|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
398471|NCT00466310|B2|Baseline|Recurrent Episode Schizophrenics|These subjects have had at least one prior schizophrenic episode.
398472|NCT00466310|B1|Baseline|First Episode Schizophrenics|These are subjects with no prior schizophrenic episodes
398473|NCT00466310|P3|Participant Flow|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
398474|NCT00466310|P2|Participant Flow|Recurrent Episode Schizophrenics|Schizophrenia subjects with at least one prior episode
398475|NCT00466310|P1|Participant Flow|First Episode Schizophrenics|Schizophrenia subjects with no prior episodes
398476|NCT00466310|O3|Outcome|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
398477|NCT00466310|O2|Outcome|Recurrent Episode Schizophrenics|Schizophrenia subjects with at least one prior episode
398478|NCT00466310|O1|Outcome|First Episode Schizophrenics|Schizophrenia subjects with no prior episodes
398479|NCT00466310|E3|Reported Event|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
398480|NCT00466310|E2|Reported Event|Recurrent Episode Schizophrenics|These subjects have had at least one prior schizophrenic episode.
398481|NCT00466310|E1|Reported Event|First Episode Schizophrenics|These are subjects with no prior schizophrenic episodes
398482|NCT00466323|B3|Baseline|Total|Total of all reporting groups
398483|NCT00466323|B2|Baseline|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
398484|NCT00466323|B1|Baseline|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
398485|NCT00466323|P2|Participant Flow|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
398486|NCT00466323|P1|Participant Flow|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
398487|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
398488|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
398523|NCT00471718|O1|Outcome|ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
399029|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398489|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
398490|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
398491|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
398492|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
398493|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
398494|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
398495|NCT00466323|E2|Reported Event|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
398496|NCT00466323|E1|Reported Event|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
398497|NCT00471705|B4|Baseline|Total|Total of all reporting groups
398498|NCT00471705|B3|Baseline|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
398499|NCT00471705|B2|Baseline|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
398500|NCT00471705|B1|Baseline|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
398501|NCT00471705|P3|Participant Flow|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
398502|NCT00471705|P2|Participant Flow|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
398503|NCT00471705|P1|Participant Flow|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
398504|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
398505|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
398506|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
398507|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
398508|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
398509|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
398510|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
398511|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
398512|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
398513|NCT00471705|E3|Reported Event|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
398514|NCT00471705|E2|Reported Event|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
398515|NCT00471705|E1|Reported Event|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
398516|NCT00471718|B1|Baseline|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
398517|NCT00471718|P1|Participant Flow|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
398518|NCT00471718|O1|Outcome|Phase I/11: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
398519|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle.
398520|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle.
398521|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
398522|NCT00471718|O1|Outcome|Phase I/11: ABT-751|Duration of overall response from time measurements are met for CR or PR until date that recurrence or PD is objectively documented
398524|NCT00471718|E1|Reported Event|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
398525|NCT00471822|B1|Baseline|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
398526|NCT00471822|P1|Participant Flow|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
398527|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
398528|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
398529|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
398530|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
398531|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
398532|NCT00471822|E1|Reported Event|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
398533|NCT00472030|B3|Baseline|Total|Total of all reporting groups
398534|NCT00472030|B2|Baseline|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
398535|NCT00472030|B1|Baseline|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 16 weeks.
398536|NCT00472030|P2|Participant Flow|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
398537|NCT00472030|P1|Participant Flow|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
398538|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
398539|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
398540|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
398541|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
398542|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
398543|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
398544|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Research subjects enrolled to the Omalizumab treatment arm will be treated with Omalizumab on Day 1 and at Week 2,4,6,8,10,12,& 14.
398545|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
398546|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with Omalizumab on Day 1, Week 2,4,6,8,10,12 and 14.
398547|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
398548|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
398549|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
398550|NCT00472030|E2|Reported Event|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
398551|NCT00472030|E1|Reported Event|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 16 weeks.
398552|NCT00472056|B5|Baseline|Total|Total of all reporting groups
398553|NCT00472056|B4|Baseline|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
398554|NCT00472056|B3|Baseline|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
398555|NCT00472056|B2|Baseline|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
398556|NCT00472056|B1|Baseline|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
398557|NCT00472056|P4|Participant Flow|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
398558|NCT00472056|P3|Participant Flow|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
398559|NCT00472056|P2|Participant Flow|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
398560|NCT00472056|P1|Participant Flow|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
425851|NCT00542386|B1|Baseline|MCI-196: 3 g|MCI-196: 3 g/ day
398561|NCT00472056|O2|Outcome|High Dose Rituximab|High dose arm: Rituximab 1000mg/m^2 intravenous on days +1 and +8 after stem cell infusion
398562|NCT00472056|O1|Outcome|Standard Dose Rituximab|Standard dose arm: Rituximab 375 mg/m^2 intravenous on days +1 and +8 after stem cell infusion.
398563|NCT00472056|E4|Reported Event|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
398564|NCT00472056|E3|Reported Event|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
398565|NCT00472056|E2|Reported Event|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
398566|NCT00472056|E1|Reported Event|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
398567|NCT00472082|B1|Baseline|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.
efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
398568|NCT00472082|P1|Participant Flow|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.
efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
398569|NCT00472082|O1|Outcome|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.
efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
398570|NCT00472082|O1|Outcome|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.
efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
398571|NCT00472082|E1|Reported Event|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.
efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
398572|NCT00472199|B3|Baseline|Total|Total of all reporting groups
398573|NCT00472199|B2|Baseline|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398574|NCT00472199|B1|Baseline|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398575|NCT00472199|P2|Participant Flow|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398576|NCT00472199|P1|Participant Flow|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398577|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
399024|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398578|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398579|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398580|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398581|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398582|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398583|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398584|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398585|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398586|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398587|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398588|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398589|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398590|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398591|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398592|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398593|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398594|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398595|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398596|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398597|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398598|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
425873|NCT00542386|E3|Reported Event|MCI-196: 9 g|MCI-196: 9 g/ day
398599|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398600|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398601|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398602|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398603|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398604|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398605|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398606|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398607|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398608|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398609|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398610|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398611|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398612|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398613|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398614|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398615|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398616|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398617|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398618|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398619|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398769|NCT00472576|O1|Outcome|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
398770|NCT00472576|E2|Reported Event|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
398620|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398621|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398622|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398623|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398624|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398625|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398626|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398627|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398628|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398629|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398630|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398631|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398632|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398633|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398634|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398635|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398636|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398637|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398638|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398639|NCT00472199|E2|Reported Event|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398640|NCT00472199|E1|Reported Event|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
398641|NCT00472290|B1|Baseline|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
398642|NCT00472290|P1|Participant Flow|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
398643|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
398644|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
398645|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
398646|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
398647|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
398648|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
398649|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
398650|NCT00472290|E1|Reported Event|Romiplostim|
398651|NCT00472303|B3|Baseline|Total|Total of all reporting groups
398652|NCT00472303|B2|Baseline|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398653|NCT00472303|B1|Baseline|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398654|NCT00472303|P3|Participant Flow|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo received 100 mg tapentadol prolonged release (PR) twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398655|NCT00472303|P2|Participant Flow|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398656|NCT00472303|P1|Participant Flow|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398657|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398658|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398659|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398660|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398661|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398662|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398663|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398664|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398665|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).
398666|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398667|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398668|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398669|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase
398670|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398671|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398672|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398673|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398674|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398675|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398676|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398677|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398678|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398679|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398680|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398681|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398682|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398683|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398684|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398685|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398686|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398687|NCT00472303|O1|Outcome|Tapentadol Extended Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398688|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398689|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398690|NCT00472303|O5|Outcome|Morphine Controlled Release Maintenance Phase|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398771|NCT00472576|E1|Reported Event|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
398691|NCT00472303|O4|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily in the titration phase. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).
398692|NCT00472303|O3|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398693|NCT00472303|O2|Outcome|Morphine Controlled Release Titration Phase|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses
398694|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398695|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398696|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398697|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398698|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398699|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398700|NCT00472303|O3|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398701|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398702|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398703|NCT00472303|O1|Outcome|Morphine Controlled Release (Titration Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398704|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398705|NCT00472303|O3|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398706|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398707|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398708|NCT00472303|O1|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398709|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398710|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398711|NCT00472303|O2|Outcome|Morphine Controlled Release (Maintenance Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398712|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
398713|NCT00472303|E5|Reported Event|Morphine Controlled Release (Maintenance Phase)|Oral Morphine 40 mg to 100 mg twice daily. The dose that was effective at the end of the Titration Phase.
398772|NCT00472641|B1|Baseline|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day
Ziprasidone/Geodon: Ziprasidone/Geodon"
398773|NCT00472641|P1|Participant Flow|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day
Ziprasidone/Geodon: Ziprasidone/Geodon"
398714|NCT00472303|E4|Reported Event|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
398715|NCT00472303|E3|Reported Event|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. The participant continued at the dose that was effective at the end of the Titration Phase.
398716|NCT00472303|E2|Reported Event|Morphine Controlled Release (Titration Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398717|NCT00472303|E1|Reported Event|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
398718|NCT00472420|B1|Baseline|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
398719|NCT00472420|P1|Participant Flow|Rituximab Plus (+) Chemotherapy|Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or orally (PO), on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, every 12 hours (q12h) on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
398720|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
398721|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
398722|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
398723|NCT00472420|E1|Reported Event|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
398724|NCT00472446|B5|Baseline|Total|Total of all reporting groups
398774|NCT00472641|O1|Outcome|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day
Ziprasidone/Geodon: Ziprasidone/Geodon"
398775|NCT00472641|O1|Outcome|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day
Ziprasidone/Geodon: Ziprasidone/Geodon"
398776|NCT00472641|E1|Reported Event|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day
Ziprasidone/Geodon: Ziprasidone/Geodon"
398777|NCT00472732|B3|Baseline|Total|Total of all reporting groups
398725|NCT00472446|B4|Baseline|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398726|NCT00472446|B3|Baseline|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398727|NCT00472446|B2|Baseline|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398728|NCT00472446|B1|Baseline|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398729|NCT00472446|P4|Participant Flow|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398730|NCT00472446|P3|Participant Flow|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398731|NCT00472446|P2|Participant Flow|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398732|NCT00472446|P1|Participant Flow|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398733|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398734|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398735|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398736|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398778|NCT00472732|B2|Baseline|Healthy Males or Females Without Known Medical or Metabolic di|Healthy males or females without known medical or metabolic disorder (control group)
398779|NCT00472732|B1|Baseline|Female Carriers of Ornithine Transcarbamylase Deficiency (OTCD|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
398887|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
398737|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398738|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398739|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398740|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398741|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398742|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398743|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398744|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398745|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398746|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398747|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398748|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398749|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398750|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398751|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398752|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398753|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398754|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398755|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398756|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398757|NCT00472446|E4|Reported Event|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398758|NCT00472446|E3|Reported Event|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)
placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398759|NCT00472446|E2|Reported Event|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398760|NCT00472446|E1|Reported Event|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)
bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.
Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
398761|NCT00472576|B3|Baseline|Total|Total of all reporting groups
398762|NCT00472576|B2|Baseline|MK-0657 Then Placebo|Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
398763|NCT00472576|B1|Baseline|Placebo Then MK-0657|Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
398764|NCT00472576|P2|Participant Flow|MK-0657 Then Placebo|Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
398765|NCT00472576|P1|Participant Flow|Placebo Then MK-0657|Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
398766|NCT00472576|O2|Outcome|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
398767|NCT00472576|O1|Outcome|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
398768|NCT00472576|O2|Outcome|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
398780|NCT00472732|P2|Participant Flow|Healthy Males or Females Without Known Medical or Metabolic di|Healthy males or females without known medical or metabolic disorder (control group)
398781|NCT00472732|P1|Participant Flow|Female Carriers of Ornithine Transcarbamylase Deficiency (OTCD|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
398782|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
398783|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
398784|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
398785|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
398786|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
398787|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
398788|NCT00472732|E2|Reported Event|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
398789|NCT00472732|E1|Reported Event|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
398790|NCT00472797|B3|Baseline|Total|Total of all reporting groups
398791|NCT00472797|B2|Baseline|New Formulation of Rebif - Titrated|
398792|NCT00472797|B1|Baseline|New Formulation of Rebif - Non-Titrated|
398793|NCT00472797|P2|Participant Flow|New Formulation of Rebif - Titrated|The new frmulation of rebif is not approved and under investigation in the US
398794|NCT00472797|P1|Participant Flow|New Formulation of Rebif - Non-Titrated|The new formulation of rebif is not approved and under investigation in the US
398795|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
398796|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
398797|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
398798|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
398799|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
398800|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
398801|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
398802|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
398803|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
398804|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
398805|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
398806|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
398807|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
398808|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
398809|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
398810|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
398811|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
398812|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
398813|NCT00472797|O1|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
398814|NCT00472797|E3|Reported Event|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
398815|NCT00472797|E2|Reported Event|Titrated|New formulation of rebif
398816|NCT00472797|E1|Reported Event|Non-Titrated|New formulation of rebif
398817|NCT00472849|B3|Baseline|Total|Total of all reporting groups
398818|NCT00472849|B2|Baseline|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
398819|NCT00472849|B1|Baseline|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
398820|NCT00472849|P2|Participant Flow|OFAR (Phase II)|Oxaliplatin 25 mg/m^2 IV per day (Phase I MTD) on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
398821|NCT00472849|P1|Participant Flow|OFAR (Phase I)|Oxaliplatin starting dose 30 mg/m^2/day over 2 hours on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily intravenous (IV) over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
398822|NCT00472849|O1|Outcome|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
398888|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
398823|NCT00472849|O1|Outcome|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
398824|NCT00472849|E2|Reported Event|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
398825|NCT00472849|E1|Reported Event|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
398826|NCT00473083|B4|Baseline|Total|Total of all reporting groups
398827|NCT00473083|B3|Baseline|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
398828|NCT00473083|B2|Baseline|Arm 2: Reactive Treatmen|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
398829|NCT00473083|B1|Baseline|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
398830|NCT00473083|P3|Participant Flow|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
398831|NCT00473083|P2|Participant Flow|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
398832|NCT00473083|P1|Participant Flow|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
398833|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
398889|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
399025|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398834|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
398835|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
398836|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
398837|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
398838|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
398839|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
398840|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
398841|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
398842|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
398890|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
399026|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398843|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
398844|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
398845|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
398846|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
398847|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
398848|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
398849|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
398850|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
398851|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
398872|NCT00473330|P1|Participant Flow|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
398891|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
398852|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
398853|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
398854|NCT00473083|E3|Reported Event|Arm 3: Treat Only if Grade 3 Rash Occurs|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
398855|NCT00473083|E2|Reported Event|Arm 2: Treat Only Upon Initiation of Rash|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
398856|NCT00473083|E1|Reported Event|Arm 1: Rash Prevention|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
398857|NCT00473265|B1|Baseline|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
398858|NCT00473265|P1|Participant Flow|PTH1-84|participants received PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
398859|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
398860|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
398861|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
398862|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
398863|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
398864|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
398865|NCT00473265|E1|Reported Event|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
398866|NCT00473330|B4|Baseline|Total|Total of all reporting groups
398867|NCT00473330|B3|Baseline|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
398868|NCT00473330|B2|Baseline|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
398869|NCT00473330|B1|Baseline|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
398870|NCT00473330|P3|Participant Flow|Sham Injection/Ranibizumab 0.5 mg|Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
398871|NCT00473330|P2|Participant Flow|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
399027|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398873|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398874|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398875|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398876|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398877|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398878|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398879|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398880|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398881|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398882|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398883|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398884|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398885|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398886|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
425874|NCT00542386|E2|Reported Event|MCI-196: 6 g|MCI-196: 6 g/ day
398892|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398893|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398894|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
398895|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
398896|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398897|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398898|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398899|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398900|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398901|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398902|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
398903|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
398904|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398905|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398906|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398907|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398908|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398909|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398910|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398911|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398912|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398913|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398914|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398915|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398916|NCT00473330|O3|Outcome|Sham Injection|Patients received a sham intravitreal injection monthly for 24 months.
398917|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
398918|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
398919|NCT00473330|E7|Reported Event|Ranibizumab 0.5 mg - Months 37-60|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
398920|NCT00473330|E6|Reported Event|Ranibizumab 0.3 mg - Months 37-60|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
398921|NCT00473330|E5|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 37-60|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
398922|NCT00473330|E4|Reported Event|Ranibizumab 0.5 mg - Months 0-36|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
398923|NCT00473330|E3|Reported Event|Ranibizumab 0.3 mg - Months 0-36|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
398924|NCT00473330|E2|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 0-36|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
398925|NCT00473330|E1|Reported Event|Sham Injection - Months 0-24|Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.
398926|NCT00473382|B4|Baseline|Total|Total of all reporting groups
398927|NCT00473382|B3|Baseline|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
398928|NCT00473382|B2|Baseline|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
399028|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398929|NCT00473382|B1|Baseline|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
398930|NCT00473382|P3|Participant Flow|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
398931|NCT00473382|P2|Participant Flow|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
398932|NCT00473382|P1|Participant Flow|Sham Injection/Ranibizumab 0.5 mg|Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
398933|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398934|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398935|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398936|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398937|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398938|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398939|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398940|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398941|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398942|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398962|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398943|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398944|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398945|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398946|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398947|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398948|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398949|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
398950|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
398951|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
398952|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398953|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398954|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398955|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398956|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398957|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398958|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive Ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398959|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398960|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398961|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398978|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
398963|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
398964|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398965|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398966|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398967|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398968|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398969|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398970|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398971|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398972|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398973|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
398974|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398975|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
398976|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
398977|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
398979|NCT00473382|E7|Reported Event|Ranibizumab 0.5 mg - Months 37-60|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
398980|NCT00473382|E6|Reported Event|Ranibizumab 0.3 mg - Months 37-60|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
398981|NCT00473382|E5|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 37-60|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
398982|NCT00473382|E4|Reported Event|Ranibizumab 0.5 mg - Months 0-36|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
398983|NCT00473382|E3|Reported Event|Ranibizumab 0.3 mg - Months 0-36|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
398984|NCT00473382|E2|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 0-36|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
398985|NCT00473382|E1|Reported Event|Sham Injection - Months 0-24|Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.
398986|NCT00473434|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398987|NCT00473434|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398988|NCT00473434|O9|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398989|NCT00473434|O8|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398990|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398991|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398992|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398993|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398994|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398995|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398996|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398997|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398998|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
398999|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399000|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399001|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399002|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399003|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399004|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399005|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399006|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399007|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399008|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399009|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399010|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399011|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399012|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399013|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399014|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399015|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399016|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399017|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399018|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399019|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399020|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399021|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399022|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399023|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399031|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399032|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399033|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399034|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399035|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399036|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399037|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399038|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399039|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399040|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399041|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399042|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399043|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399044|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399045|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399046|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399047|NCT00473434|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
399048|NCT00479388|B3|Baseline|Total|Total of all reporting groups
399049|NCT00479388|B2|Baseline|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
399050|NCT00479388|B1|Baseline|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
399051|NCT00479388|P2|Participant Flow|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
399052|NCT00479388|P1|Participant Flow|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
399053|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
399054|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
399055|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
399056|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
399057|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
399058|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
399059|NCT00479388|E2|Reported Event|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
399060|NCT00479388|E1|Reported Event|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
399061|NCT00479401|B4|Baseline|Total|Total of all reporting groups
399062|NCT00479401|B3|Baseline|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399063|NCT00479401|B2|Baseline|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399064|NCT00479401|B1|Baseline|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399065|NCT00479401|P3|Participant Flow|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399066|NCT00479401|P2|Participant Flow|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399067|NCT00479401|P1|Participant Flow|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399068|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399069|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399070|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399071|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399072|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399073|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399074|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399075|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399076|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399077|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399078|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399079|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399080|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399081|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399082|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399083|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399084|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399085|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399086|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399087|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399088|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399089|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399090|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399091|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399092|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399093|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399094|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399095|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399096|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399097|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399098|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399099|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399100|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399101|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399102|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399103|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399104|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399105|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399106|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399107|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399108|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399109|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399110|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399111|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399112|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399113|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399114|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399115|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399116|NCT00479401|E3|Reported Event|Placebo|Placebo to PPX ER once and to PPX IR three times a day
399117|NCT00479401|E2|Reported Event|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
399118|NCT00479401|E1|Reported Event|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
399119|NCT00479466|B7|Baseline|Total|Total of all reporting groups
399120|NCT00479466|B6|Baseline|Metformin HCL|
399121|NCT00479466|B5|Baseline|MK0893 80 mg|
399122|NCT00479466|B4|Baseline|MK0893 60 mg|
399123|NCT00479466|B3|Baseline|MK0893 40 mg|
399124|NCT00479466|B2|Baseline|MK0893 20 mg|
399125|NCT00479466|B1|Baseline|Placebo|
399126|NCT00479466|P6|Participant Flow|Metformin HCL|
399127|NCT00479466|P5|Participant Flow|MK0893 80 mg|
399128|NCT00479466|P4|Participant Flow|MK0893 60 mg|
399129|NCT00479466|P3|Participant Flow|MK0893 40 mg|
399130|NCT00479466|P2|Participant Flow|MK0893 20 mg|
399131|NCT00479466|P1|Participant Flow|Placebo|
399132|NCT00479466|O6|Outcome|Metformin HCL|
399133|NCT00479466|O5|Outcome|MK0893 80 mg|
399134|NCT00479466|O4|Outcome|MK0893 60 mg|
399135|NCT00479466|O3|Outcome|MK0893 40 mg|
399136|NCT00479466|O2|Outcome|MK0893 20 mg|
399137|NCT00479466|O1|Outcome|Placebo|
399138|NCT00479466|O6|Outcome|Metformin HCL|
399139|NCT00479466|O5|Outcome|MK0893 80 mg|
399140|NCT00479466|O4|Outcome|MK0893 60 mg|
399141|NCT00479466|O3|Outcome|MK0893 40 mg|
399142|NCT00479466|O2|Outcome|MK0893 20 mg|
399143|NCT00479466|O1|Outcome|Placebo|
399144|NCT00479466|O6|Outcome|Metformin HCL|
399145|NCT00479466|O5|Outcome|MK0893 80 mg|
399146|NCT00479466|O4|Outcome|MK0893 60 mg|
399147|NCT00479466|O3|Outcome|MK0893 40 mg|
399148|NCT00479466|O2|Outcome|MK0893 20 mg|
399149|NCT00479466|O1|Outcome|Placebo|
399150|NCT00479466|E6|Reported Event|Metformin HCL|
399151|NCT00479466|E5|Reported Event|MK0893 80 mg|
399152|NCT00479466|E4|Reported Event|MK0893 60 mg|
399153|NCT00479466|E3|Reported Event|MK0893 40 mg|
399154|NCT00479466|E2|Reported Event|MK0893 20 mg|
399155|NCT00479466|E1|Reported Event|Placebo|
399157|NCT00479557|B7|Baseline|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399158|NCT00479557|B6|Baseline|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399159|NCT00479557|B5|Baseline|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399160|NCT00479557|B4|Baseline|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399161|NCT00479557|B3|Baseline|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399162|NCT00479557|B2|Baseline|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399163|NCT00479557|B1|Baseline|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399164|NCT00479557|P7|Participant Flow|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399165|NCT00479557|P6|Participant Flow|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399166|NCT00479557|P5|Participant Flow|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399167|NCT00479557|P4|Participant Flow|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399168|NCT00479557|P3|Participant Flow|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399169|NCT00479557|P2|Participant Flow|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399170|NCT00479557|P1|Participant Flow|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399171|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399172|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399173|NCT00479557|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399174|NCT00479557|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399175|NCT00479557|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399176|NCT00479557|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399177|NCT00479557|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399178|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399179|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399180|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399181|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399182|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399183|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399184|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399185|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399186|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399187|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399188|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399189|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399190|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399248|NCT00483652|O2|Outcome|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
399191|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399192|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399193|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399194|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399195|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399196|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399197|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399198|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399199|NCT00479557|E7|Reported Event|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399200|NCT00479557|E6|Reported Event|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399201|NCT00479557|E5|Reported Event|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399202|NCT00479557|E4|Reported Event|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399203|NCT00479557|E3|Reported Event|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399204|NCT00479557|E2|Reported Event|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399205|NCT00479557|E1|Reported Event|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
399206|NCT00479674|B1|Baseline|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
399207|NCT00479674|P1|Participant Flow|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
399208|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
399209|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
399210|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
399249|NCT00483652|O1|Outcome|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
399250|NCT00483652|E2|Reported Event|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
399251|NCT00483652|E1|Reported Event|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
399252|NCT00483704|B4|Baseline|Total|Total of all reporting groups
399275|NCT00483704|O2|Outcome|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
399276|NCT00483704|O1|Outcome|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
399612|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399211|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
399212|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
399213|NCT00479674|E1|Reported Event|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
399214|NCT00479713|B3|Baseline|Total|Total of all reporting groups
399215|NCT00479713|B2|Baseline|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399216|NCT00479713|B1|Baseline|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399217|NCT00479713|P2|Participant Flow|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399218|NCT00479713|P1|Participant Flow|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399219|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399220|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399221|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399222|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399223|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399224|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399225|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399226|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399227|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399228|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399229|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399230|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399231|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399232|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399233|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399234|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399235|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399236|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399237|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399238|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399239|NCT00479713|E2|Reported Event|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
399240|NCT00479713|E1|Reported Event|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
399241|NCT00483652|B3|Baseline|Total|Total of all reporting groups
399242|NCT00483652|B2|Baseline|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
399243|NCT00483652|B1|Baseline|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
399244|NCT00483652|P2|Participant Flow|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
399245|NCT00483652|P1|Participant Flow|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
399246|NCT00483652|O2|Outcome|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
399247|NCT00483652|O1|Outcome|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
399253|NCT00483704|B3|Baseline|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399254|NCT00483704|B2|Baseline|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399255|NCT00483704|B1|Baseline|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399256|NCT00483704|P3|Participant Flow|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399257|NCT00483704|P2|Participant Flow|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399258|NCT00483704|P1|Participant Flow|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399259|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399260|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399261|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399262|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399263|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399264|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399265|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399266|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399267|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399268|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399269|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399270|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399271|NCT00483704|O3|Outcome|Placebo|Participants who received at least one dose of placebo.
399272|NCT00483704|O2|Outcome|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
399273|NCT00483704|O1|Outcome|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
399274|NCT00483704|O3|Outcome|Placebo|Participants who received at least one dose of placebo.
399277|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399278|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399279|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399280|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399281|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399282|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399283|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399284|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399285|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399286|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399287|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399288|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399289|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399290|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399291|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399292|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399293|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399294|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399331|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399606|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399609|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399295|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
399296|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
399297|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
399298|NCT00483704|E3|Reported Event|Placebo|Participants who received at least one dose of placebo.
399299|NCT00483704|E2|Reported Event|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
399300|NCT00483704|E1|Reported Event|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
399301|NCT00483717|B3|Baseline|Total|Total of all reporting groups
399302|NCT00483717|B2|Baseline|Placebo|"Intranasal Placebo
Placebo : Intranasal (IN) placebo"
399303|NCT00483717|B1|Baseline|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
399304|NCT00483717|P2|Participant Flow|Placebo|"Intranasal Placebo
Placebo : Intranasal (IN) placebo"
399305|NCT00483717|P1|Participant Flow|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
399306|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo
Placebo : Intranasal (IN) placebo"
399307|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
399308|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo
Placebo : Intranasal (IN) placebo"
399309|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
399310|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo
Placebo : Intranasal (IN) placebo"
399311|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
399312|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo
Placebo : Intranasal (IN) placebo"
399313|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
399314|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo
Placebo : Intranasal (IN) placebo"
399315|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
399316|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo
Placebo : Intranasal (IN) placebo"
399317|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
399318|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo
Placebo : Intranasal (IN) placebo"
399319|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
399320|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo
Placebo : Intranasal (IN) placebo"
399321|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
399322|NCT00483717|E2|Reported Event|Placebo|"Intranasal Placebo
Placebo : Intranasal (IN) placebo"
399323|NCT00483717|E1|Reported Event|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
399324|NCT00483756|B4|Baseline|Total|Total of all reporting groups
399325|NCT00483756|B3|Baseline|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399326|NCT00483756|B2|Baseline|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399327|NCT00483756|B1|Baseline|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399328|NCT00483756|P3|Participant Flow|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399329|NCT00483756|P2|Participant Flow|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399330|NCT00483756|P1|Participant Flow|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399332|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399333|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399334|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399335|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399336|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399337|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399338|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399339|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399340|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399341|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399342|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399343|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399344|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399345|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399346|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399347|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399348|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399349|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399350|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399351|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399352|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399443|NCT00484159|O1|Outcome|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
399607|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399353|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399354|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399355|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399356|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399357|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399358|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399359|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399360|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399361|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399362|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399363|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399364|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399365|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399366|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399367|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399368|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399369|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399370|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399371|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399372|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399373|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399444|NCT00484159|O3|Outcome|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
399608|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399374|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399375|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399376|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399377|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399378|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399379|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399380|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399381|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399382|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399383|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399384|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399385|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399386|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399387|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399388|NCT00483756|E3|Reported Event|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399389|NCT00483756|E2|Reported Event|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
399390|NCT00483756|E1|Reported Event|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
399391|NCT00483938|B8|Baseline|Total|Total of all reporting groups
399392|NCT00483938|B7|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399393|NCT00483938|B6|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399394|NCT00483938|B5|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
399395|NCT00483938|B4|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399445|NCT00484159|O2|Outcome|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
399396|NCT00483938|B3|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
399397|NCT00483938|B2|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
399398|NCT00483938|B1|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
399399|NCT00483938|P7|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399400|NCT00483938|P6|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399401|NCT00483938|P5|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
399402|NCT00483938|P4|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399403|NCT00483938|P3|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
399404|NCT00483938|P2|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
399405|NCT00483938|P1|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
399406|NCT00483938|O6|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399407|NCT00483938|O5|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
399408|NCT00483938|O4|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399409|NCT00483938|O3|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
399410|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
399411|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
399412|NCT00483938|O4|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399413|NCT00483938|O3|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
399414|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399415|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
399446|NCT00484159|O1|Outcome|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
399447|NCT00484159|E3|Reported Event|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
399416|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
399417|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
399418|NCT00483938|E7|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399419|NCT00483938|E6|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399420|NCT00483938|E5|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
399421|NCT00483938|E4|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
399422|NCT00483938|E3|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
399423|NCT00483938|E2|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
399424|NCT00483938|E1|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
399425|NCT00484094|B1|Baseline|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
399426|NCT00484094|P1|Participant Flow|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
399427|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
399428|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
399429|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
399430|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
399431|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
399432|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
399433|NCT00484094|E1|Reported Event|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
399434|NCT00484159|B4|Baseline|Total|Total of all reporting groups
399435|NCT00484159|B3|Baseline|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
399436|NCT00484159|B2|Baseline|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
399437|NCT00484159|B1|Baseline|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
399438|NCT00484159|P3|Participant Flow|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
399439|NCT00484159|P2|Participant Flow|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
399440|NCT00484159|P1|Participant Flow|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
399441|NCT00484159|O3|Outcome|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
399442|NCT00484159|O2|Outcome|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
399448|NCT00484159|E2|Reported Event|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
399449|NCT00484159|E1|Reported Event|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
399450|NCT00484185|B1|Baseline|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399451|NCT00484185|P1|Participant Flow|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399452|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399453|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399454|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399455|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399456|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399457|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399458|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399459|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399460|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399461|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399462|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399463|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399464|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399465|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399466|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399467|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399468|NCT00484185|E1|Reported Event|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
399469|NCT00484289|B4|Baseline|Total|Total of all reporting groups
399470|NCT00484289|B3|Baseline|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399471|NCT00484289|B2|Baseline|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399602|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399472|NCT00484289|B1|Baseline|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399473|NCT00484289|P3|Participant Flow|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399474|NCT00484289|P2|Participant Flow|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399475|NCT00484289|P1|Participant Flow|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399476|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399477|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399478|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399479|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399480|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399481|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399482|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399483|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399484|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399485|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399486|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399487|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399488|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399489|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399603|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399490|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399491|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399492|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399493|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399494|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399495|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399496|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399497|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399498|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399499|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399500|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399501|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399502|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399503|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399504|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399505|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399506|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399507|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399508|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399509|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399510|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399511|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399512|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399513|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399514|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399515|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399516|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399517|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399518|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399519|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399520|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399521|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399522|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399523|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399524|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399525|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399526|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399527|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399528|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399529|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399530|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399531|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399532|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399533|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399534|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399535|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399536|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399537|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399538|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399539|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399540|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399541|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399542|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399543|NCT00484289|E3|Reported Event|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399544|NCT00484289|E2|Reported Event|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
399545|NCT00484289|E1|Reported Event|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
399546|NCT00484315|B3|Baseline|Total|Total of all reporting groups
399547|NCT00484315|B2|Baseline|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
399548|NCT00484315|B1|Baseline|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
399549|NCT00484315|P2|Participant Flow|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
399550|NCT00484315|P1|Participant Flow|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
399551|NCT00484315|O2|Outcome|TAXUS Express|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
399552|NCT00484315|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
399553|NCT00484315|O2|Outcome|TAXUS Express|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
399554|NCT00484315|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
399555|NCT00484315|E2|Reported Event|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
399556|NCT00484315|E1|Reported Event|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
399557|NCT00484393|B3|Baseline|Total|Total of all reporting groups
399558|NCT00484393|B2|Baseline|Placebo First|Placebo cream (Aquatain) 1g applied to inejction site first, then tetracaine with subsequent injection
399559|NCT00484393|B1|Baseline|Tetracaine First|Tetracaine 4% gel 1g applied to injection site first, then placebo with subsequent injection
399560|NCT00484393|P2|Participant Flow|Placebo Then Tetracaine|Placebo cream (Aquatain) 1g applied to inejction site prior to next palivizumab injection after enrollment Tetracaine 4% gel 1g applied to injection site prior to subsequent palivizumab injection (1 month after 1st study injection)
399561|NCT00484393|P1|Participant Flow|Tetracaine Then Placebo|Tetracaine 4% gel 1g applied to injection site prior to next palivizumab injection after enrollment Placebo cream (Aquatain) 1g applied to inejction site prior to subsequent palivizumab injection (1 month after 1st study injection)
399562|NCT00484393|O2|Outcome|Placebo|Placebo cream (Aquatain) 1g applied to inejction site
399563|NCT00484393|O1|Outcome|Tetracaine|Tetracaine 4% gel 1g applied to injection site
399564|NCT00484393|E2|Reported Event|Placebo|"Placebo cream (Aquatain) 1g applied to inejction site
Placebo: placebo applied prior to 1 injection"
399565|NCT00484393|E1|Reported Event|Tetracaine|"Tetracaine 4% gel 1g applied to injection site
tetracaine 4% gel: tetracaine applied prior to 1 injection"
399566|NCT00484419|B4|Baseline|Total|Total of all reporting groups
399567|NCT00484419|B3|Baseline|Sitagliptin|sitagliptin phosphate tablets 100mg
399568|NCT00484419|B2|Baseline|Rosiglitazone|rosiglitazone maleate 4mg
399569|NCT00484419|B1|Baseline|Colesevelam|colesevelam tablets 625 mg
399570|NCT00484419|P3|Participant Flow|Sitagliptin|sitagliptin phosphate tablets 100mg
399571|NCT00484419|P2|Participant Flow|Rosiglitazone|rosiglitazone maleate 4mg
399572|NCT00484419|P1|Participant Flow|Colesevelam|colesevelam tablets 625 mg
399573|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399574|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399575|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399576|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399577|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399578|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399579|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399580|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399581|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399582|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399583|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399584|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399585|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399586|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399587|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399588|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399589|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399590|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399591|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399592|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399593|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399594|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399595|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399596|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399597|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399598|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399599|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399600|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399601|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399615|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399616|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399617|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399618|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399619|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399620|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399621|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399622|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399623|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399624|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
399625|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
399626|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
399627|NCT00484679|B1|Baseline|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
399628|NCT00484679|P1|Participant Flow|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
399629|NCT00484679|O1|Outcome|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
399630|NCT00484679|E1|Reported Event|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
399631|NCT00484939|B3|Baseline|Total|Total of all reporting groups
399632|NCT00484939|B2|Baseline|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399633|NCT00484939|B1|Baseline|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399634|NCT00484939|P2|Participant Flow|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399635|NCT00484939|P1|Participant Flow|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399636|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399637|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399638|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399639|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399640|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399641|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399642|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399643|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399644|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399645|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399646|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399647|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399648|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399649|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399650|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
425875|NCT00542386|E1|Reported Event|MCI-196: 3 g|MCI-196: 3 g/ day
399651|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399652|NCT00484939|E2|Reported Event|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399854|NCT00485433|B1|Baseline|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
399653|NCT00484939|E1|Reported Event|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
399654|NCT00485069|B3|Baseline|Total|Total of all reporting groups
399655|NCT00485069|B2|Baseline|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399656|NCT00485069|B1|Baseline|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399657|NCT00485069|P2|Participant Flow|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399658|NCT00485069|P1|Participant Flow|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399659|NCT00485069|O2|Outcome|"ROP+L-Dopa, On Hours"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399660|NCT00485069|O1|Outcome|"ROP+L-Dopa, Off Hours"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399661|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399662|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399663|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399664|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399665|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399711|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399713|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399855|NCT00485433|P4|Participant Flow|SKY0402 High Dose|SKY0402 high dose given during hernia repair
399666|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399667|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399668|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399669|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399670|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399671|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399672|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399673|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399674|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399675|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399676|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399677|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399678|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399679|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399680|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399681|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399682|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399683|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off Sate (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399684|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399685|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399686|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399687|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399688|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399689|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399690|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399691|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
425876|NCT00542425|B6|Baseline|Total|Total of all reporting groups
399692|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399693|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399694|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399695|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399696|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399697|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399698|NCT00485069|E2|Reported Event|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
399699|NCT00485069|E1|Reported Event|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
399700|NCT00485173|B3|Baseline|Total|Total of all reporting groups
399701|NCT00485173|B2|Baseline|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399702|NCT00485173|B1|Baseline|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399703|NCT00485173|P2|Participant Flow|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399704|NCT00485173|P1|Participant Flow|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399705|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399706|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399707|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399708|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399709|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399710|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399712|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399851|NCT00485433|B4|Baseline|SKY0402 High Dose|SKY0402 high dose given during hernia repair
399714|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399715|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399716|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399717|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399718|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399719|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399720|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399721|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399722|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399723|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399724|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399725|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399726|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399727|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399728|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399729|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399730|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399731|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399732|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399733|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399734|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399735|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399736|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399737|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399738|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399739|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399740|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399741|NCT00485173|E2|Reported Event|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
399742|NCT00485173|E1|Reported Event|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
399743|NCT00485264|B7|Baseline|Total|Total of all reporting groups
399770|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
455101|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
399744|NCT00485264|B6|Baseline|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399745|NCT00485264|B5|Baseline|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399746|NCT00485264|B4|Baseline|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399747|NCT00485264|B3|Baseline|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399748|NCT00485264|B2|Baseline|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399749|NCT00485264|B1|Baseline|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399750|NCT00485264|P6|Participant Flow|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399751|NCT00485264|P5|Participant Flow|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399752|NCT00485264|P4|Participant Flow|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399753|NCT00485264|P3|Participant Flow|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399754|NCT00485264|P2|Participant Flow|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399755|NCT00485264|P1|Participant Flow|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399756|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399757|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399758|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399759|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399760|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399761|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399762|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399763|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399764|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399765|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399766|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399767|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399768|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399769|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399850|NCT00485433|B5|Baseline|Total|Total of all reporting groups
425877|NCT00542425|B5|Baseline|Teriparatide|
399771|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399772|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399773|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399774|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399775|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399776|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399777|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399778|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399779|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399780|NCT00485264|O6|Outcome|Cohort V -Data Not Included in This Interim Analysis.|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399781|NCT00485264|O5|Outcome|Cohort IV -Data Not Included in This Interim Analysis.|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399782|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399783|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399784|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399785|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399786|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399787|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399788|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399789|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399790|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399791|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399792|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399793|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399794|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399795|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399796|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399797|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
455102|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
399798|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399799|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399800|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399801|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399802|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399803|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399804|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399805|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399806|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399807|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399808|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399809|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399810|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399811|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399812|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399813|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399814|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399815|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399816|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399817|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399818|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399819|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399820|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399821|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399822|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399823|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399852|NCT00485433|B3|Baseline|SKY0402 Middle Dose|SKY0402 middle dose given during hernia repair
399853|NCT00485433|B2|Baseline|SKY0402 Low Dose|SKY0402 low dose given during hernia repair
399824|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399825|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399826|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399827|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399828|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399829|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
399830|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399831|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399832|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399833|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399834|NCT00485264|E4|Reported Event|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399835|NCT00485264|E3|Reported Event|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
399836|NCT00485264|E2|Reported Event|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
399837|NCT00485264|E1|Reported Event|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
399838|NCT00485303|B1|Baseline|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399839|NCT00485303|P1|Participant Flow|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399840|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399841|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399842|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399843|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399844|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399845|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399846|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399847|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399848|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399849|NCT00485303|E1|Reported Event|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
399856|NCT00485433|P3|Participant Flow|SKY0402 Middle Dose|SKY0402 middle dose given during hernia repair
399857|NCT00485433|P2|Participant Flow|SKY0402 Low Dose|SKY0402 low dose given during hernia repair
399858|NCT00485433|P1|Participant Flow|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
399859|NCT00485433|O4|Outcome|SKY0402 High Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
399860|NCT00485433|O3|Outcome|SKY0402 Middle Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
399861|NCT00485433|O2|Outcome|SKY0402 Low Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
399862|NCT00485433|O1|Outcome|Bupivacaine HCl 105mg|A single dose of 105 mg bupivacaine in a 42-mL injection volume administered via local infiltration during surgery
399863|NCT00485433|E2|Reported Event|SKY0402 (All Doses)|SKY0402 given during hernia repair
399864|NCT00485433|E1|Reported Event|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
399865|NCT00485472|B3|Baseline|Total|Total of all reporting groups
399866|NCT00485472|B2|Baseline|Placebo|Placebo
399867|NCT00485472|B1|Baseline|Lacosamide|Lacosamide (LCM) 400 mg/day
399868|NCT00485472|P2|Participant Flow|Placebo|Placebo
399869|NCT00485472|P1|Participant Flow|Lacosamide|Lacosamide (LCM) 400 mg/day
399870|NCT00485472|O2|Outcome|Placebo|Placebo
399871|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
399872|NCT00485472|O2|Outcome|Placebo|Placebo
399873|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
399874|NCT00485472|O2|Outcome|Placebo|Placebo
399875|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
399876|NCT00485472|O2|Outcome|Placebo|Placebo
399877|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
399878|NCT00485472|O2|Outcome|Placebo|Placebo
399879|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
399880|NCT00485472|O2|Outcome|Placebo|Placebo
399881|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
399882|NCT00485472|O2|Outcome|Placebo|Placebo
399883|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
399884|NCT00485472|O2|Outcome|Placebo|Placebo
399885|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
399886|NCT00485472|O2|Outcome|Placebo|Placebo
399887|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
399888|NCT00485472|E2|Reported Event|Placebo|Placebo
399889|NCT00485472|E1|Reported Event|Lacosamide|Lacosamide (LCM) 400 mg/day
399890|NCT00485485|B1|Baseline|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
399891|NCT00485485|P1|Participant Flow|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
399892|NCT00485485|O1|Outcome|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
399893|NCT00485485|E1|Reported Event|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
399894|NCT00485693|B3|Baseline|Total|Total of all reporting groups
399895|NCT00485693|B2|Baseline|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
399896|NCT00485693|B1|Baseline|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
399897|NCT00485693|P2|Participant Flow|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
399898|NCT00485693|P1|Participant Flow|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
399899|NCT00485693|O5|Outcome|SKY0402 High Dose|Single administration of study drug in a volume of 60 mL via local infiltration
399900|NCT00485693|O4|Outcome|SKY0402 High-mid Dose|Single administration of study drug in a volume of 60 mL via local infiltration
399901|NCT00485693|O3|Outcome|SKY0402 Low-mid Dose|Single administration of study drug in a volume of 60 mL via local infiltration
399902|NCT00485693|O2|Outcome|SKY0402 Low Dose|Single administration of study drug in a volume of 60 mL via local infiltration
399903|NCT00485693|O1|Outcome|Bupivacaine HCl|Single administration of 150 mg bupivacaine HCl in a 60-mL injection volume (undiluted)
399904|NCT00485693|E2|Reported Event|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
399905|NCT00485693|E1|Reported Event|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
399906|NCT00485732|B3|Baseline|Total|Total of all reporting groups
399907|NCT00485732|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
399908|NCT00485732|B1|Baseline|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
399909|NCT00485732|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
399910|NCT00485732|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
399911|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
399912|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
399913|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
399914|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
399915|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
400043|NCT00465530|E2|Reported Event|Saline (Once Daily, 40 mL to Each Nostril)|
399916|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
399917|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
399918|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
399919|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
399920|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
399921|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
399922|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
399923|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
399924|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
399925|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
399926|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
399927|NCT00485732|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
399928|NCT00485732|E1|Reported Event|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
399929|NCT00485758|B3|Baseline|Total|Total of all reporting groups
399930|NCT00485758|B2|Baseline|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
399931|NCT00485758|B1|Baseline|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).
No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
399932|NCT00485758|P2|Participant Flow|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
399933|NCT00485758|P1|Participant Flow|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).
No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
399934|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
399935|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).
No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
399936|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
399937|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).
No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
399938|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
399939|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).
No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
399940|NCT00485758|E2|Reported Event|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
399941|NCT00485758|E1|Reported Event|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).
No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
399942|NCT00485836|B4|Baseline|Total|Total of all reporting groups
399943|NCT00485836|B3|Baseline|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399944|NCT00485836|B2|Baseline|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399945|NCT00485836|B1|Baseline|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399946|NCT00485836|P3|Participant Flow|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399947|NCT00485836|P2|Participant Flow|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399948|NCT00485836|P1|Participant Flow|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399949|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399950|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399951|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399952|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399953|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399954|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399955|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399956|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399957|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399958|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399959|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399960|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399961|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399962|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399963|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399964|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399965|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399966|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399967|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399968|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399969|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399970|NCT00485836|E3|Reported Event|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399971|NCT00485836|E2|Reported Event|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399972|NCT00485836|E1|Reported Event|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399973|NCT00485953|B3|Baseline|Total|Total of all reporting groups
399974|NCT00485953|B2|Baseline|Placebo Group|Received placebo medication once per week
399975|NCT00485953|B1|Baseline|Active Medicine Group|risedronate 35 mg weekly
399976|NCT00485953|P2|Participant Flow|Placebo Group|Received placebo medication once per week
399977|NCT00485953|P1|Participant Flow|Active Medication Group|"risedronate 35 mg weekly
risedronate: risedronate 35 mg per week"
399978|NCT00485953|O2|Outcome|Placebo Group|Received placebo medication once weekly
399979|NCT00485953|O1|Outcome|Active Medicine Group|risedronate 35 mg weekly
399980|NCT00485953|E2|Reported Event|Placebo Group|Receive placebo medication once per week
399981|NCT00485953|E1|Reported Event|Active Medicine Group|risedronate 35 mg weekly
399982|NCT00486018|B4|Baseline|Total|Total of all reporting groups
399983|NCT00486018|B3|Baseline|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399984|NCT00486018|B2|Baseline|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399985|NCT00486018|B1|Baseline|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399986|NCT00486018|P3|Participant Flow|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399987|NCT00486018|P2|Participant Flow|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399988|NCT00486018|P1|Participant Flow|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399989|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399990|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
425878|NCT00542425|B4|Baseline|BA058 80 µg|
399991|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399992|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399993|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399994|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399995|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399996|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399997|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
399998|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
399999|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
400000|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
400001|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
400002|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
400003|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
400004|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
400005|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
400006|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
400007|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
400008|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
400009|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
400010|NCT00486018|E3|Reported Event|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
400011|NCT00486018|E2|Reported Event|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
400012|NCT00486018|E1|Reported Event|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
400013|NCT00486044|B3|Baseline|Total|Total of all reporting groups
400014|NCT00486044|B2|Baseline|Placebo|Matching placebo tablet nightly for 9 months
400015|NCT00486044|B1|Baseline|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
400016|NCT00486044|P2|Participant Flow|Placebo|Matching placebo tablet nightly for 9 months
400017|NCT00486044|P1|Participant Flow|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
400018|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
400019|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
400020|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
400021|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
400022|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
400023|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
400024|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
400025|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
400026|NCT00486044|E2|Reported Event|Placebo|Matching placebo tablet nightly for 9 months
400027|NCT00486044|E1|Reported Event|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
400028|NCT00465361|B1|Baseline|Intervention|Performance after receiving feedback and educational module
400029|NCT00465361|P1|Participant Flow|Intervention|Performance after receiving feedback and educational module
400030|NCT00465361|O1|Outcome|Intervention|Performance after receiving feedback and educational module
400031|NCT00465361|E1|Reported Event|Intervention|Performance after receiving feedback and educational module
400032|NCT00465530|B3|Baseline|Total|Total of all reporting groups
400033|NCT00465530|B2|Baseline|Saline (Once Daily, 40 mL to Each Nostril)|
400034|NCT00465530|B1|Baseline|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
400035|NCT00465530|P2|Participant Flow|Saline (Once Daily, 40 mL to Each Nostril)|
400036|NCT00465530|P1|Participant Flow|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
400037|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
400038|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
400039|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
400040|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
400041|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
400042|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
400044|NCT00465530|E1|Reported Event|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
400045|NCT00476476|B3|Baseline|Total|Total of all reporting groups
400046|NCT00476476|B2|Baseline|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
400047|NCT00476476|B1|Baseline|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
400048|NCT00476476|P2|Participant Flow|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
400049|NCT00476476|P1|Participant Flow|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
400050|NCT00476476|O2|Outcome|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
400051|NCT00476476|O1|Outcome|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
400052|NCT00476476|E1|Reported Event|Erlotinib|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
400053|NCT00476593|B5|Baseline|Total|Total of all reporting groups
400054|NCT00476593|B4|Baseline|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
400055|NCT00476593|B3|Baseline|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
400056|NCT00476593|B2|Baseline|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
400057|NCT00476593|B1|Baseline|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
400058|NCT00476593|P4|Participant Flow|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
400059|NCT00476593|P3|Participant Flow|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
400060|NCT00476593|P2|Participant Flow|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
400061|NCT00476593|P1|Participant Flow|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
400062|NCT00476593|O4|Outcome|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
400063|NCT00476593|O3|Outcome|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
400064|NCT00476593|O2|Outcome|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
400065|NCT00476593|O1|Outcome|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
400066|NCT00476593|E4|Reported Event|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
400067|NCT00476593|E3|Reported Event|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
400068|NCT00476593|E2|Reported Event|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
402689|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
400069|NCT00476593|E1|Reported Event|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
400070|NCT00476645|B1|Baseline|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
400071|NCT00476645|P1|Participant Flow|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
400072|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
400073|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
400074|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
400075|NCT00476645|E1|Reported Event|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
400076|NCT00476788|B1|Baseline|Omnipod Device|Patients will be placed on an Omnipod insulin pump
400077|NCT00476788|P1|Participant Flow|Omnipod Device|Patients will be placed on an Omnipod insulin pump
400078|NCT00476788|O1|Outcome|Omnipod Device|Patients will be placed on an Omnipod insulin pump
400079|NCT00476788|O1|Outcome|Omnipod Device|Patients will be placed on an Omnipod insulin pump
400080|NCT00476788|E1|Reported Event|Omnipod Device|Patients will be placed on an Omnipod insulin pump
400081|NCT00486226|B1|Baseline|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device and were consented before the procedure.
Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
400082|NCT00486226|P1|Participant Flow|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device (VRD).
Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
400083|NCT00486226|O2|Outcome|Endovascular - Occlusion Results at 6 Months Follow-up|Aneurysm occlusion assessed at 6 months follow-up using the Raymond Scale.
400084|NCT00486226|O1|Outcome|Endovascular - Occlusion Results Immediately Post-procedure|Aneurysm occlusion was assessed immediately post procedure using the Raymond Scale.
400085|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.
Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
400086|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device.
Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
400087|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.
Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
400088|NCT00486226|E1|Reported Event|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.
Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
400089|NCT00486252|B1|Baseline|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400090|NCT00486252|P1|Participant Flow|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400091|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400092|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400093|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400094|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400095|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400096|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400097|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400098|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400099|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400100|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400101|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400102|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400103|NCT00486252|E1|Reported Event|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
400104|NCT00486265|B1|Baseline|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
400105|NCT00486265|P1|Participant Flow|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
400106|NCT00486265|O1|Outcome|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
400107|NCT00486265|E1|Reported Event|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
400108|NCT00486278|B1|Baseline|All Subjects|A total of 51 subjects with 96 qualifying bleeds were treated in the study. A subject could contribute with up to one qualifying bleeding episode per study arm.
400109|NCT00486278|P1|Participant Flow|All Subjects|A total of 51 subjects with 96 qualifying bleeds were treated in the study. A subject could contribute with up to one qualifying bleeding episode per study arm.
400110|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400111|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400112|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400113|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400114|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400115|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400116|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400117|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400118|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400119|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400120|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400121|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400122|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400123|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400124|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400125|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400126|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400127|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400128|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400129|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400130|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400131|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400132|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400133|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400336|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
400134|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400135|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400136|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400137|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400138|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400139|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400140|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400141|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400142|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400143|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400144|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400145|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400146|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400147|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400148|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400149|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400150|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400151|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400152|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400153|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400154|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400155|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400156|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400300|NCT00487162|O1|Outcome|Strict Glycemic Control|strict glycemic control: intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
400157|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400158|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400159|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400160|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400161|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400162|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400163|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400164|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400165|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400166|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400167|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400168|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400169|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400170|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400171|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400172|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400173|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400174|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400175|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400176|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400177|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400178|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400179|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400180|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400332|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
400181|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400182|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400183|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400184|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400185|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400186|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400187|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400188|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400189|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400190|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400191|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400192|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400193|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400194|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400195|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400196|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400197|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400198|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400199|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400200|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400201|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400202|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400203|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400204|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400333|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
400205|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400206|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400207|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400208|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400209|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400210|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400211|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400212|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400213|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400214|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400215|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400216|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400217|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400218|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400219|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400220|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400221|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400222|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400223|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400224|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400225|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400226|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400227|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400228|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400334|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
400229|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400230|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400231|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400232|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400233|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400234|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400235|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400236|NCT00486278|E6|Reported Event|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
400237|NCT00486278|E5|Reported Event|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400238|NCT00486278|E4|Reported Event|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400239|NCT00486278|E3|Reported Event|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400240|NCT00486278|E2|Reported Event|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400241|NCT00486278|E1|Reported Event|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
400242|NCT00486291|B3|Baseline|Total|Total of all reporting groups
400243|NCT00486291|B2|Baseline|Placebo|Matched placebo
400244|NCT00486291|B1|Baseline|Active|Phentermine 15mg/topiramate 100mg
400245|NCT00486291|P2|Participant Flow|Placebo|Matched placebo
400246|NCT00486291|P1|Participant Flow|Active|Phentermine 15mg/topiramate 100mg
400247|NCT00486291|O2|Outcome|Placebo|Matched placebo
400248|NCT00486291|O1|Outcome|Active|Phentermine 15mg and topiramate 100mg
400249|NCT00486291|O2|Outcome|Placebo|Matched placebo
400250|NCT00486291|O1|Outcome|Active|Phentermine 15mg and topiramate 100mg
400251|NCT00486291|E2|Reported Event|Placebo|Matched placebo
400252|NCT00486291|E1|Reported Event|Active|Phentermine 15mg/topiramate 100mg
400253|NCT00486330|B1|Baseline|Tipranavir/Ritonavir (500mg/200mg)|
400254|NCT00486330|P1|Participant Flow|Tipranavir/Ritonavir (500mg/200mg)|Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg (TPV/r) was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
400255|NCT00486330|O1|Outcome|Tipranavir/Ritonavir (500mg/200mg)|Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
400256|NCT00486330|E1|Reported Event|Tipranavir/Ritonavir (500mg/200mg)|
400257|NCT00486434|B3|Baseline|Total|Total of all reporting groups
400258|NCT00486434|B2|Baseline|Placebo Arm|1 SMC021 Placebo tablet twice daily
400259|NCT00486434|B1|Baseline|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
400260|NCT00486434|P2|Participant Flow|Placebo Arm|1 SMC021 Placebo tablet twice daily
400261|NCT00486434|P1|Participant Flow|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
400262|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
400263|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
400264|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
400265|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
400266|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
400267|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
400268|NCT00486434|E2|Reported Event|Placebo Arm|1 SMC021 Placebo tablet twice daily
400269|NCT00486434|E1|Reported Event|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
400270|NCT00487084|B4|Baseline|Total|Total of all reporting groups
400335|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
400271|NCT00487084|B3|Baseline|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
400337|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
400272|NCT00487084|B2|Baseline|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
400273|NCT00487084|B1|Baseline|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
400274|NCT00487084|P3|Participant Flow|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
400275|NCT00487084|P2|Participant Flow|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
400276|NCT00487084|P1|Participant Flow|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
400277|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
400278|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
400279|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
400280|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
400281|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
400282|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
400283|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
400284|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
400285|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
400286|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
400287|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
400288|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
400289|NCT00487084|E3|Reported Event|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
400290|NCT00487084|E2|Reported Event|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
400291|NCT00487084|E1|Reported Event|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
400292|NCT00487162|B3|Baseline|Total|Total of all reporting groups
400293|NCT00487162|B2|Baseline|Intensive Glycemic Control|In this treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50mL of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg/dL and will be adjusted to maintain the blood glucose level between 80 and 110 mg/dL.
400294|NCT00487162|B1|Baseline|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200 mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.
400295|NCT00487162|P2|Participant Flow|Intensive Glycemic Control|In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50ml of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg / dL on two consecutive samples and will be adjusted to maintain the blood glucose level between 80 and 110 mg / dL. Adjustments will be made according to the University Hospital's ICU Adult Insulin Infusion Protocol - modified 10/1/07 (Appendix A). When the blood glucose level falls below 80 mg / dL, the insulin infusion will be tapered and discontinued. For patients going to the ICU after surgery, insulin infusions will be continued according to the University Hospital's ICU Adult Insulin Infusion Protocol under the direction of the ICU staff. For patients not being to the ICU after surgery, insulin infusions will be tapered to off after the final hourly blood glucose determination at three hours after the completion of surgery.
400296|NCT00487162|P1|Participant Flow|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to thie care provider discretion.
400297|NCT00487162|O2|Outcome|Conventional Glycemic Control|conventional glycemic control: Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl
400298|NCT00487162|O1|Outcome|Strict Glycemic Control|strict glycemic control: intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
400299|NCT00487162|O2|Outcome|Conventional Glycemic Control|conventional glycemic control: Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl
400338|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
400301|NCT00487162|E2|Reported Event|Intensive Glycemic Control|Subjects randomized to this group had glucose levels monitored hourly and when >110mg/dL an insulin drip was initiated to maintain glucose levels between 80-110
400302|NCT00487162|E1|Reported Event|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.
400303|NCT00487188|B3|Baseline|Total|Total of all reporting groups
400304|NCT00487188|B2|Baseline|HAART|Participants received highly active antiretroviral treatment.
400305|NCT00487188|B1|Baseline|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
400306|NCT00487188|P3|Participant Flow|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
400307|NCT00487188|P2|Participant Flow|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
400308|NCT00487188|P1|Participant Flow|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
400309|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
400310|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
400311|NCT00487188|O3|Outcome|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
400312|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
400313|NCT00487188|O1|Outcome|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
400314|NCT00487188|O3|Outcome|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
400315|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
400316|NCT00487188|O1|Outcome|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
400317|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
400318|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.
This group contains all patients who entered the Maintenance Phase from the ENF+HAART Induction Phase, regardless of which arm they were randomized to at BL2."
400319|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
400320|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.
This group contains all patients who entered the Maintenance Phase from the ENF+HAART Induction Phase, regardless of which arm they were randomized to at BL2."
400321|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
400322|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.
This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
400323|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
400324|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.
This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
400325|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
400326|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.
This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
400327|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
400328|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.
This group contains all patients who were randomized to ENF+HAART at BL1 and follows the patients throughout 48 weeks, regardless of which arm they were randomized to at BL2."
400329|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
400330|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
400331|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
400339|NCT00487188|E5|Reported Event|Maintenance Phase: HAART|During the Maintenance Phase, participants who had received HAART alone and who responded to treatment during the Induction Phase continued to receive highly active antiretroviral treatment for up to 48 weeks of total treatment.
400340|NCT00487188|E4|Reported Event|Maintenance Phase: HAART (ENF Removed)|During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive HAART alone during the Maintenance Phase, for up to a total of 48 weeks treatment.
400341|NCT00487188|E3|Reported Event|Maintenance Phase: ENF + HAART|During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for up to 48 weeks of total treatment.
400342|NCT00487188|E2|Reported Event|Induction Phase: HAART|During the Induction Phase participants received highly active antiretroviral treatment for a maximum of 32 weeks.
400343|NCT00487188|E1|Reported Event|Induction: ENF+HAART|During the Induction Phase participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for a maximum of 32 weeks.
400344|NCT00487240|B3|Baseline|Total|Total of all reporting groups
400345|NCT00487240|B2|Baseline|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400346|NCT00487240|B1|Baseline|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400347|NCT00487240|P2|Participant Flow|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400348|NCT00487240|P1|Participant Flow|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400349|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400350|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400351|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400352|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400353|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400354|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400355|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400356|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400357|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400358|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400359|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400360|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400361|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400362|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400363|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400364|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400365|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400366|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400367|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400368|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400369|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400370|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400371|NCT00487240|E2|Reported Event|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
400372|NCT00487240|E1|Reported Event|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
400373|NCT00487279|B3|Baseline|Total|Total of all reporting groups
400375|NCT00487279|B1|Baseline|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
400376|NCT00487279|P2|Participant Flow|Control Group|Medical therapy alone
400377|NCT00487279|P1|Participant Flow|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
400378|NCT00487279|O2|Outcome|Control Group|Medical therapy alone
455966|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
400379|NCT00487279|O1|Outcome|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
400380|NCT00487279|O2|Outcome|Control Group|Medical therapy alone
400381|NCT00487279|O1|Outcome|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
400382|NCT00487279|E2|Reported Event|Control Group|Medical therapy alone
400383|NCT00487279|E1|Reported Event|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
400384|NCT00487396|B1|Baseline|SB Capsule Then Standard Ileocolonoscopy|Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
400385|NCT00487396|P1|Participant Flow|SB Capsule Then Standard Ileocolonoscopy|Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
400386|NCT00487396|O2|Outcome|Small Bowel Follow Through(SBFT) Followed by Ileo-colonoscopy|Patients subsequently had SBFT followed by ileo-colonoscopy .
400387|NCT00487396|O1|Outcome|PillCam SB Followed by Ileo Colonoscopy|Ingestible capsule equipped with an endoscope with one imagers, before ileo-colonoscopy.
400388|NCT00487396|E2|Reported Event|Adverse Events Related to Capsule|AE related to the capsule endoscopy procedure
400389|NCT00487396|E1|Reported Event|Adverse Events Related to Ileocolonoscopy|AE related to the ileocolonoscopy procedure
400390|NCT00487435|B1|Baseline|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
400391|NCT00487435|P1|Participant Flow|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
400392|NCT00487435|O1|Outcome|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
400393|NCT00487435|O1|Outcome|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
400394|NCT00487435|E1|Reported Event|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
400395|NCT00487461|B4|Baseline|Total|Total of all reporting groups
400396|NCT00487461|B3|Baseline|Study Group #2|"Simvastatin 80 mg
Simvastatin: Comparing two doses of Simvastatin to placebo"
400397|NCT00487461|B2|Baseline|Study Group #1|"Simvastatin 40 mg
Simvastatin: Comparing two doses of Simvastatin to placebo"
400398|NCT00487461|B1|Baseline|Control Group|"Placebo tablet
Placebo: Placebo tablet"
400399|NCT00487461|P3|Participant Flow|Study Group #2|"Simvastatin 80 mg
Simvastatin: Comparing two doses of Simvastatin to placebo"
400400|NCT00487461|P2|Participant Flow|Study Group #1|"Simvastatin 40 mg
Simvastatin: Comparing two doses of Simvastatin to placebo"
400401|NCT00487461|P1|Participant Flow|Control Group|"Placebo tablet
Placebo: Placebo tablet"
400402|NCT00487461|O3|Outcome|Study Group #2|"Simvastatin 80 mg
Simvastatin: Comparing two doses of Simvastatin to placebo"
400403|NCT00487461|O2|Outcome|Study Group #1|"Simvastatin 40 mg
Simvastatin: Comparing two doses of Simvastatin to placebo"
400404|NCT00487461|O1|Outcome|Control Group|"Placebo tablet
Placebo: Placebo tablet"
400405|NCT00487461|O3|Outcome|Study Group #2|"Simvastatin 80 mg
Simvastatin: Comparing two doses of Simvastatin to placebo"
400406|NCT00487461|O2|Outcome|Study Group #1|"Simvastatin 40 mg
Simvastatin: Comparing two doses of Simvastatin to placebo"
400407|NCT00487461|O1|Outcome|Control Group|"Placebo tablet
Placebo: Placebo tablet"
400408|NCT00487461|E3|Reported Event|Study Group #2|"Simvastatin 80 mg
Simvastatin: Comparing two doses of Simvastatin to placebo"
400409|NCT00487461|E2|Reported Event|Study Group #1|"Simvastatin 40 mg
Simvastatin: Comparing two doses of Simvastatin to placebo"
400410|NCT00487461|E1|Reported Event|Control Group|"Placebo tablet
Placebo: Placebo tablet"
400411|NCT00487539|B5|Baseline|Total|Total of all reporting groups
400412|NCT00487539|B4|Baseline|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
400413|NCT00487539|B3|Baseline|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
400414|NCT00487539|B2|Baseline|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
400415|NCT00487539|B1|Baseline|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
400416|NCT00487539|P4|Participant Flow|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 200 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
400417|NCT00487539|P3|Participant Flow|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 100 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
400418|NCT00487539|P2|Participant Flow|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
400419|NCT00487539|P1|Participant Flow|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
400420|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
400421|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
400422|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
400423|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
456095|NCT00622388|O1|Outcome|Overall Study Arm|
400424|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
400425|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
400426|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
400427|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
400428|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
400429|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
400430|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
400431|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
400432|NCT00487539|E4|Reported Event|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
400433|NCT00487539|E3|Reported Event|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
400434|NCT00487539|E2|Reported Event|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
400435|NCT00487539|E1|Reported Event|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
400436|NCT00487552|B1|Baseline|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
400437|NCT00487552|P1|Participant Flow|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
400438|NCT00487552|O1|Outcome|Magnetic Anastomosis Device (MAD)|Magnetic Anastomosis Device (MAD) used for palliative treatment of gastric outlet obstruction.
400439|NCT00487552|O1|Outcome|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
400440|NCT00487552|E1|Reported Event|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
400441|NCT00487565|B1|Baseline|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
400442|NCT00487565|P1|Participant Flow|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
400443|NCT00487565|O1|Outcome|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
400444|NCT00487565|E1|Reported Event|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
400445|NCT00487578|B3|Baseline|Total|Total of all reporting groups
400446|NCT00487578|B2|Baseline|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400447|NCT00487578|B1|Baseline|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400448|NCT00487578|P2|Participant Flow|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400449|NCT00487578|P1|Participant Flow|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400450|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400451|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400452|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400453|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400454|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400455|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400456|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400457|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400458|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400459|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400460|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400461|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400462|NCT00487578|E2|Reported Event|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400463|NCT00487578|E1|Reported Event|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
400464|NCT00487669|B1|Baseline|Paclitaxel Poliglumex With Pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
401085|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
400493|NCT00487721|B1|Baseline|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
400494|NCT00487721|P2|Participant Flow|Control|Subjects in the control arm did not receive any treatment or placebo.
400465|NCT00487669|P1|Participant Flow|Paclitaxel Poliglumex With Pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
400466|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
400467|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
400468|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
400469|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
400470|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
400471|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
400472|NCT00487669|E2|Reported Event|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
400473|NCT00487669|E1|Reported Event|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
400474|NCT00487695|B1|Baseline|All Study Participants|Patients received both procedures (CLE and standard EGD), so baseline characteristics are reported for the group
400475|NCT00487695|P2|Participant Flow|Standard EGD Followed by CLE|Patients in this group were randomized to have standard EGD followed by CLE 6 weeks later
400476|NCT00487695|P1|Participant Flow|CLE Followed by Standard EGD|Patients randomized to either CLE or standard endoscopy first. The other procedure was then performed 6 weeks later. This group was randomized to CLE first, followed by standard endoscopy
400477|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400478|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400479|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400480|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400481|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400482|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400483|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400484|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400485|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400486|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400487|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400488|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
400489|NCT00487695|E2|Reported Event|Standard EGD|Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)
400490|NCT00487695|E1|Reported Event|Confocal Laser Endomicroscopy|Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)
400491|NCT00487721|B3|Baseline|Total|Total of all reporting groups
400492|NCT00487721|B2|Baseline|Control|Subjects in the control arm did not receive any treatment or placebo.
401086|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
400495|NCT00487721|P1|Participant Flow|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
400496|NCT00487721|O1|Outcome|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
400497|NCT00487721|E2|Reported Event|Control|Subjects in the control arm did not receive any treatment or placebo.
400498|NCT00487721|E1|Reported Event|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
400499|NCT00487747|B1|Baseline|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
400500|NCT00487747|P1|Participant Flow|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a [Pegasys], 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
400501|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
400502|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
400503|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
400504|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
400505|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
400506|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
400507|NCT00487747|E1|Reported Event|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
400508|NCT00487825|B3|Baseline|Total|Total of all reporting groups
400509|NCT00487825|B2|Baseline|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
400510|NCT00487825|B1|Baseline|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
400511|NCT00487825|P2|Participant Flow|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
400512|NCT00487825|P1|Participant Flow|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
400513|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
400514|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
400515|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
400516|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
400517|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
400518|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
400519|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
400520|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
400521|NCT00487825|E2|Reported Event|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
400522|NCT00487825|E1|Reported Event|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
400524|NCT00487942|B4|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
401091|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
400525|NCT00487942|B3|Baseline|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400526|NCT00487942|B2|Baseline|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400527|NCT00487942|B1|Baseline|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400528|NCT00487942|P4|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400529|NCT00487942|P3|Participant Flow|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400530|NCT00487942|P2|Participant Flow|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400531|NCT00487942|P1|Participant Flow|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400532|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400533|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400534|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400535|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400536|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400537|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400538|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400539|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400540|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400541|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400542|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
401087|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
401088|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
401092|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
403452|NCT00492336|P1|Participant Flow|Rasagiline|Treatment with Rasagiline
400543|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400544|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400545|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400546|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400547|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400548|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400549|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400550|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400551|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400552|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400553|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400554|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400555|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400556|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400557|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400558|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400559|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400560|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400561|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400562|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400563|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400564|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400565|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400566|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400567|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400568|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400569|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400570|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400571|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400572|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400573|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400574|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400575|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400576|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400577|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400578|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400579|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400580|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400581|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400582|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400583|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400584|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400585|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400586|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400587|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400588|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400589|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400590|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400591|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400592|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400593|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400594|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400595|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400596|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400597|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400598|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400599|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400600|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400601|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400602|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400603|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400604|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400605|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400606|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400607|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400608|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400609|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400610|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400611|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400612|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400613|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400614|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400615|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400616|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400617|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400618|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400619|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400620|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400621|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400622|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400623|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400624|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400625|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400626|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400627|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400628|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400629|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400630|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400631|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400632|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400633|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400634|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400635|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400636|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400637|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400638|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400639|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400640|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400641|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400642|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400643|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400644|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400645|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400646|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400647|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400648|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400649|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400650|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400651|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400652|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400653|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400654|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400655|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400656|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400657|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400658|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400659|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400660|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400661|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400662|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400663|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400664|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400665|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400666|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400667|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400668|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400669|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400670|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400671|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400672|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400673|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400674|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400675|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400676|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400677|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400678|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400679|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400680|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400681|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400682|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400683|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400684|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400685|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400686|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400687|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400688|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400689|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400690|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400691|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400692|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400693|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400694|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400695|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400696|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400697|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400698|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400699|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400700|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400701|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400702|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400703|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400704|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400705|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400706|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400707|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400708|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400709|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400710|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400711|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400712|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400713|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400714|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400715|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400716|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400717|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400718|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400719|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400720|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400721|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400722|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400723|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400724|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400725|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400726|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400727|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400728|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400729|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400730|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400731|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400732|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400733|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400734|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400735|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400736|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400737|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400738|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400739|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400740|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400741|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400742|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400743|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400744|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400745|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400746|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400747|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400748|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400749|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400750|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400751|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400752|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400753|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400754|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400755|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400756|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400757|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400758|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400759|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400760|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400761|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400762|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400763|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400764|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400765|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400766|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400767|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400768|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400769|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400770|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400771|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400772|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400773|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400774|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400775|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400776|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400777|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400778|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400779|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400780|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400781|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400782|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400783|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400784|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400785|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400786|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400787|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400788|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400789|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400790|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400791|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400792|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400793|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400794|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400795|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400796|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400797|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400798|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400799|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400800|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400801|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400802|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400803|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400804|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400805|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400806|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400807|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400808|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400809|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400810|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400811|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400812|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400813|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400814|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400815|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400816|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400817|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400818|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400819|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400820|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400821|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400822|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400823|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400824|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400825|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400826|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400827|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400828|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400829|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400830|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400831|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400832|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400833|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400834|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400835|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400836|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400837|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400838|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400839|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400840|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400841|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400842|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400843|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400844|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400845|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400846|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400847|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400848|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400849|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400850|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400851|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400852|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400853|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400854|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400855|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400856|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400857|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400858|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400859|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400860|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400861|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400862|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400863|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400864|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400865|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400866|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400867|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400868|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400869|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400870|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400871|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400872|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400873|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400874|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400875|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400876|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400877|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400878|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400879|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400880|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400881|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400882|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400883|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400884|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400885|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400886|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400887|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400888|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400889|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400890|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400891|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400892|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400893|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400894|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400895|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400896|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400897|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400898|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400899|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400900|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400901|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400902|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400903|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400904|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400905|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400906|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400907|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400908|NCT00487942|E4|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
400909|NCT00487942|E3|Reported Event|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
400910|NCT00487942|E2|Reported Event|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
400911|NCT00487942|E1|Reported Event|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
400912|NCT00487981|B1|Baseline|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
400913|NCT00487981|P1|Participant Flow|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
400914|NCT00487981|O1|Outcome|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
400915|NCT00487981|E1|Reported Event|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
400916|NCT00488033|B3|Baseline|Total|Total of all reporting groups
400917|NCT00488033|B2|Baseline|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
400918|NCT00488033|B1|Baseline|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
400919|NCT00488033|P2|Participant Flow|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
400920|NCT00488033|P1|Participant Flow|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
400921|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
400922|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
400923|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
400924|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
400925|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
400926|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
400927|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
400928|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
400929|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
400930|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
400931|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
400932|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
400933|NCT00488033|E2|Reported Event|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
400934|NCT00488033|E1|Reported Event|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
401089|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
401090|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
402747|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
400935|NCT00488059|B1|Baseline|Phase 1: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
400936|NCT00488059|P3|Participant Flow|Phase II - Arm B|Phase I then enfuvirtide 180 mg SC QD (2 x 90-mg injections) + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)
400937|NCT00488059|P2|Participant Flow|Phase II - Arm A|Phase I then enfuvirtide 90 mg SC BID + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)
400938|NCT00488059|P1|Participant Flow|Phase I|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
400939|NCT00488059|O3|Outcome|Phase II - Arm B|Phase I then ENF 180 mg SC QD
400940|NCT00488059|O2|Outcome|Phase II - Arm A|Phase I then ENF 90 mg SC BID
400941|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
400942|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to
(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
400943|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90mg BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to
(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
400944|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to
(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
400945|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90mg SC BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to
(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
400946|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
400947|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to
(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
400948|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90 mg SC BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to
(Phase II Arm A: Phase I+ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
400949|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
402748|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
400950|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
400951|NCT00488059|E3|Reported Event|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized
(Phase II Arm B: Phase I then ENF 180mg SC once daily (QD)): ENF 180 mg SC QD + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
400952|NCT00488059|E2|Reported Event|Phase II Arm A: Phase I Then ENF 90mg SC BID|"(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to
(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
400953|NCT00488059|E1|Reported Event|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
400954|NCT00488293|B3|Baseline|Total|Total of all reporting groups
400955|NCT00488293|B2|Baseline|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400956|NCT00488293|B1|Baseline|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400957|NCT00488293|P2|Participant Flow|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400958|NCT00488293|P1|Participant Flow|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400959|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400960|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400961|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400962|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400963|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400964|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400965|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400966|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400967|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400968|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400969|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400970|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400971|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400972|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400973|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400974|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400975|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400976|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400977|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400978|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400979|NCT00488293|E2|Reported Event|Conventional Referrals|"Conventional consult process
Conventional consult process: Standard electronic consult"
400980|NCT00488293|E1|Reported Event|Teledermatology Referrals|"Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
400982|NCT00488319|B3|Baseline|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400983|NCT00488319|B2|Baseline|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400984|NCT00488319|B1|Baseline|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400985|NCT00488319|P3|Participant Flow|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400986|NCT00488319|P2|Participant Flow|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400987|NCT00488319|P1|Participant Flow|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400988|NCT00488319|O4|Outcome|Total|
400989|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400990|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400991|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400992|NCT00488319|O4|Outcome|Total|
400993|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400994|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400995|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400996|NCT00488319|O4|Outcome|Total|
400997|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400998|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
400999|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401000|NCT00488319|O4|Outcome|Total|
401001|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401002|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401003|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401004|NCT00488319|O4|Outcome|Total|
401005|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401006|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401007|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401008|NCT00488319|O4|Outcome|Total|
401009|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401010|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401011|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401012|NCT00488319|O4|Outcome|Total|
401013|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401014|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401015|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401016|NCT00488319|O4|Outcome|Total|
401017|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401018|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401019|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401020|NCT00488319|O4|Outcome|Total|
401021|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401022|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401023|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401024|NCT00488319|O4|Outcome|Total|
401025|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401026|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401027|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401028|NCT00488319|O4|Outcome|Total|
401029|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401030|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401031|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401032|NCT00488319|O4|Outcome|Total|
401033|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401034|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401035|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401036|NCT00488319|O4|Outcome|Total|
401037|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401038|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401039|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401040|NCT00488319|O4|Outcome|Total|
401041|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401042|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401043|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401044|NCT00488319|O4|Outcome|Total|
401045|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401046|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401047|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401048|NCT00488319|O4|Outcome|Total|
401049|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401050|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401051|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401052|NCT00488319|O4|Outcome|Total|
401053|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401054|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401055|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401056|NCT00488319|O4|Outcome|Total|
401057|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401058|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401059|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401060|NCT00488319|O4|Outcome|Total|
401061|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401062|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401063|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401064|NCT00488319|O4|Outcome|Total|
401065|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401066|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401067|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401068|NCT00488319|E3|Reported Event|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401069|NCT00488319|E2|Reported Event|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401070|NCT00488319|E1|Reported Event|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
401071|NCT00488345|B4|Baseline|Total|Total of all reporting groups
401072|NCT00488345|B3|Baseline|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
401073|NCT00488345|B2|Baseline|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
401074|NCT00488345|B1|Baseline|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
401075|NCT00488345|P3|Participant Flow|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
401076|NCT00488345|P2|Participant Flow|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
401077|NCT00488345|P1|Participant Flow|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
401078|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
401079|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
401080|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
401081|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
401082|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
401083|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
401084|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
401093|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
401094|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
401095|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
401096|NCT00488345|E3|Reported Event|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
401097|NCT00488345|E2|Reported Event|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
401098|NCT00488345|E1|Reported Event|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
401099|NCT00488475|B1|Baseline|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401100|NCT00488475|P1|Participant Flow|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401101|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401102|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401103|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401104|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401105|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401106|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401107|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401108|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401109|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401110|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401111|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401112|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401113|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401114|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401115|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401116|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401117|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401118|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
402984|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
401119|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401120|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401121|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401122|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401123|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401124|NCT00488475|E1|Reported Event|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
401125|NCT00488488|B1|Baseline|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401126|NCT00488488|P1|Participant Flow|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401127|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401128|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401129|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401130|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401131|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401132|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401133|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401134|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401135|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401136|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401137|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401138|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401139|NCT00488488|E1|Reported Event|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
401140|NCT00488514|B1|Baseline|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
401141|NCT00488514|P1|Participant Flow|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium. A single Combination Tablet was supplied for each migraine attack, not to exceed one tablet in 24 hours.
401142|NCT00488514|O3|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401143|NCT00488514|O2|Outcome|6 Month Completer Population|Participant in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401144|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
401145|NCT00488514|O3|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401146|NCT00488514|O2|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401147|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet drug and had at least one post-treatment migraine assessment
401184|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
401237|NCT00488631|P8|Participant Flow|Golimumab 50 mg - Extension|Participants entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
401148|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401149|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
401150|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
401151|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401152|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401153|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
401154|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401155|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401156|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
401157|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401158|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401159|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
401160|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401161|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401162|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
401163|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
401164|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|
401165|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
401166|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
401167|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
401168|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
401169|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
401170|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
401171|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
401172|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
401173|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
401174|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
401175|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
401176|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
401177|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
401178|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
401179|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
401180|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
401181|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
401182|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
401183|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
401185|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401186|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401187|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
401188|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401189|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401190|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
401191|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401192|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet , completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401193|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
401194|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401195|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401196|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
401197|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
401198|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
401199|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401200|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401201|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
401202|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401203|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401204|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
401205|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401206|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401207|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
401208|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401209|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401210|NCT00488514|E3|Reported Event|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
401211|NCT00488514|E2|Reported Event|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
401212|NCT00488514|E1|Reported Event|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
401213|NCT00488592|B1|Baseline|WT1/PR1 Vaccine|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
401214|NCT00488592|P1|Participant Flow|WT1/PR1|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
401215|NCT00488592|O1|Outcome|WT1/PR1 Vaccine|Subjects with myeloid malignancies will receive WT1/PR1 vaccine to evaluate immune response to intervention.
401216|NCT00488592|E1|Reported Event|WT1/ PR1 Vaccine|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
401217|NCT00488618|B3|Baseline|Total|Total of all reporting groups
401218|NCT00488618|B2|Baseline|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
401219|NCT00488618|B1|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
401220|NCT00488618|P2|Participant Flow|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
401221|NCT00488618|P1|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
401222|NCT00488618|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
401223|NCT00488618|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
401224|NCT00488618|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
401225|NCT00488618|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
401226|NCT00488618|E2|Reported Event|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
401227|NCT00488618|E1|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
401228|NCT00488631|B7|Baseline|Total|Total of all reporting groups
401229|NCT00488631|B6|Baseline|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
401230|NCT00488631|B5|Baseline|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
401231|NCT00488631|B4|Baseline|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
401232|NCT00488631|B3|Baseline|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401233|NCT00488631|B2|Baseline|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401234|NCT00488631|B1|Baseline|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
401235|NCT00488631|P10|Participant Flow|Golimumab 200 mg Extension|Participants entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
401236|NCT00488631|P9|Participant Flow|Golimumab 100 mg Extension|Participants entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks.
401280|NCT00488644|O1|Outcome|8 Weeks Post Therapy|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks.
401238|NCT00488631|P7|Participant Flow|Placebo Extension|Participants entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.
401239|NCT00488631|P6|Participant Flow|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
401240|NCT00488631|P5|Participant Flow|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
401241|NCT00488631|P4|Participant Flow|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
401242|NCT00488631|P3|Participant Flow|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401243|NCT00488631|P2|Participant Flow|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401244|NCT00488631|P1|Participant Flow|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
401245|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401246|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401247|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
401248|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401249|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401264|NCT00488631|E14|Reported Event|Golimumab 200 mg Extension|Participants entered the study extension receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining golimumab 200 mg had their dose descreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54.
402985|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
401281|NCT00488644|E1|Reported Event|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
401282|NCT00488683|B4|Baseline|Total|Total of all reporting groups
401250|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
401251|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401252|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401253|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
401254|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401255|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401256|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
401257|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401258|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401259|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
401260|NCT00488631|E18|Reported Event|Golimumab 100 mg - 200 mg Extension|Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment.
401261|NCT00488631|E17|Reported Event|Golimumab 50 mg - 100 mg Extension|Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment
401262|NCT00488631|E16|Reported Event|Placebo - Golimumab100 mg Extension|Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment.
401263|NCT00488631|E15|Reported Event|Placebo - 50 mg Extension|A single participant entered the study extension receiving placebo subcutaneous injection administered every 4 weeks; and on worsening of UC disease had their dose increased to golimumab 50 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from the time of dose adjustment.
401265|NCT00488631|E13|Reported Event|Golimumab 100 mg Extension|Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
401266|NCT00488631|E12|Reported Event|Golimumab 50 mg Extension Phase|Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
401267|NCT00488631|E11|Reported Event|Placebo Extension|Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
401268|NCT00488631|E10|Reported Event|PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg|Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631) and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 on loss of clinical response; not randomized. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
401269|NCT00488631|E9|Reported Event|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
401270|NCT00488631|E8|Reported Event|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
401271|NCT00488631|E7|Reported Event|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
401272|NCT00488631|E6|Reported Event|GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 200 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
401273|NCT00488631|E5|Reported Event|GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
401274|NCT00488631|E4|Reported Event|GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
401275|NCT00488631|E3|Reported Event|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401276|NCT00488631|E2|Reported Event|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Adverse events are presented through Week 54.Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
401277|NCT00488631|E1|Reported Event|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
401278|NCT00488644|B1|Baseline|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
401279|NCT00488644|P1|Participant Flow|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
401357|NCT00488774|O2|Outcome|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
401283|NCT00488683|B3|Baseline|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401284|NCT00488683|B2|Baseline|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401285|NCT00488683|B1|Baseline|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401286|NCT00488683|P3|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401287|NCT00488683|P2|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401288|NCT00488683|P1|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401289|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401290|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401291|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401292|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401293|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401294|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401295|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401296|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401297|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401298|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401453|NCT00489268|B6|Baseline|Total|Total of all reporting groups
401358|NCT00488774|O1|Outcome|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
401359|NCT00488774|O4|Outcome|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
401299|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401300|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401301|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401302|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401303|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401304|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401305|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401306|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401307|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401308|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401309|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401310|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401311|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401312|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401313|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401314|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401315|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401316|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401317|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401318|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401319|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401320|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401321|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401322|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401323|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401324|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401325|NCT00488683|O3|Outcome|MenACWY-CRM + Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401326|NCT00488683|O2|Outcome|MenACWY-CRM + Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401327|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401328|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401329|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401330|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401331|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401354|NCT00488774|P1|Participant Flow|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
401355|NCT00488774|O4|Outcome|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
401332|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401333|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401334|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401335|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401336|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401337|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401338|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401339|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401340|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401341|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401342|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401343|NCT00488683|E3|Reported Event|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.
This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
401344|NCT00488683|E2|Reported Event|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.
This group had an additional blood draw at the time of enrollment."
401345|NCT00488683|E1|Reported Event|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
401346|NCT00488774|B5|Baseline|Total|Total of all reporting groups
401347|NCT00488774|B4|Baseline|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
401348|NCT00488774|B3|Baseline|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
401349|NCT00488774|B2|Baseline|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
401350|NCT00488774|B1|Baseline|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
401351|NCT00488774|P4|Participant Flow|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
401352|NCT00488774|P3|Participant Flow|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
401353|NCT00488774|P2|Participant Flow|Golimumab 1 Milligram (mg) Per Kilogram (kg)|Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
401356|NCT00488774|O3|Outcome|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0
401360|NCT00488774|O3|Outcome|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
401361|NCT00488774|O2|Outcome|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
401362|NCT00488774|O1|Outcome|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
401363|NCT00488774|E4|Reported Event|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
401364|NCT00488774|E3|Reported Event|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
401365|NCT00488774|E2|Reported Event|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
401366|NCT00488774|E1|Reported Event|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
401367|NCT00488826|B4|Baseline|Total|Total of all reporting groups
401368|NCT00488826|B3|Baseline|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
401369|NCT00488826|B2|Baseline|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
401370|NCT00488826|B1|Baseline|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
401371|NCT00488826|P3|Participant Flow|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
401372|NCT00488826|P2|Participant Flow|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
401373|NCT00488826|P1|Participant Flow|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
401374|NCT00488826|O3|Outcome|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
401375|NCT00488826|O2|Outcome|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
401376|NCT00488826|O1|Outcome|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
401377|NCT00488826|O3|Outcome|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
401378|NCT00488826|O2|Outcome|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
401379|NCT00488826|O1|Outcome|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
401380|NCT00488826|E3|Reported Event|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
401381|NCT00488826|E2|Reported Event|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
401382|NCT00488826|E1|Reported Event|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
401383|NCT00488865|B1|Baseline|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
401384|NCT00488865|P1|Participant Flow|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
401385|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
401386|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
401387|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
401388|NCT00488865|E1|Reported Event|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
401389|NCT00489086|B1|Baseline|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
401390|NCT00489086|P1|Participant Flow|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
401391|NCT00489086|O1|Outcome|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
401392|NCT00489086|E1|Reported Event|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
401393|NCT00489216|B1|Baseline|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab
efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at
1mg/kg"
401394|NCT00489216|P1|Participant Flow|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab
efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at
1mg/kg"
401395|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab
efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at
1mg/kg"
401396|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab
efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at
1mg/kg"
401578|NCT00489476|O3|Outcome|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose
Staccato Loxapine"
401591|NCT00489489|B2|Baseline|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401592|NCT00489489|B1|Baseline|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401397|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab
efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at
1mg/kg"
401398|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab
efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at
1mg/kg"
401399|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab
efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at
1mg/kg"
401400|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab
efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at
1mg/kg"
401401|NCT00489216|E1|Reported Event|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab
efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at
1mg/kg"
401402|NCT00489255|B3|Baseline|Total|Total of all reporting groups
401403|NCT00489255|B2|Baseline|Placebo|Placebo : Oral capsule, three times daily.
401404|NCT00489255|B1|Baseline|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401405|NCT00489255|P2|Participant Flow|Tigan:Placebo|Placebo : Oral capsule, three times daily.
401406|NCT00489255|P1|Participant Flow|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401407|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401408|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401409|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401410|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401411|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401412|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401413|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401414|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401415|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401416|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401417|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401418|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401419|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401420|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401421|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401422|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401423|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401424|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401425|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401426|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401427|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401428|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401429|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401430|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401431|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401432|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401433|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401434|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401435|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401436|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401437|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401438|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401439|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401440|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401441|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401442|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401443|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401444|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401445|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401446|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401447|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401448|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401449|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
401450|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401451|NCT00489255|E2|Reported Event|Placebo|Placebo : Oral capsule, three times daily.
401452|NCT00489255|E1|Reported Event|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
401454|NCT00489268|B5|Baseline|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
401455|NCT00489268|B4|Baseline|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
401456|NCT00489268|B3|Baseline|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
401457|NCT00489268|B2|Baseline|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
401458|NCT00489268|B1|Baseline|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
401459|NCT00489268|P5|Participant Flow|Phase II|In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
401460|NCT00489268|P4|Participant Flow|Phase I: 12 J/cm^2|In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
401461|NCT00489268|P3|Participant Flow|Phase I: 10 J/cm^2|In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
401462|NCT00489268|P2|Participant Flow|Phase I: 8 J/cm^2|In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
401463|NCT00489268|P1|Participant Flow|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic Intestinal Metaplasia (IM), Low-Grade Dysplasia (LGD) and High-Grade Dysplasia (HGD). The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
401464|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
401579|NCT00489476|O2|Outcome|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose
Staccato Loxapine"
401580|NCT00489476|O1|Outcome|Staccato Placebo|"Staccato Placebo, 0 mg
Staccato Placebo: Placebo aerosol inhalation (0mg)"
401465|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
401466|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
401467|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
401468|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
401469|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
401470|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
401471|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
401472|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
401581|NCT00489476|O4|Outcome|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose
Staccato Loxapine"
401582|NCT00489476|O3|Outcome|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose
Staccato Loxapine"
402986|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
401473|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
401474|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
401475|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
401476|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
401477|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
401478|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
401479|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
401480|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
401583|NCT00489476|O2|Outcome|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose
Staccato Loxapine"
401584|NCT00489476|O1|Outcome|Staccato Placebo|"Staccato Placebo, 0 mg
Staccato Placebo: Placebo aerosol inhalation (0mg)"
401481|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
401482|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
401483|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
401484|NCT00489268|E5|Reported Event|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
401485|NCT00489268|E4|Reported Event|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
401486|NCT00489268|E3|Reported Event|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
401487|NCT00489268|E2|Reported Event|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
401488|NCT00489268|E1|Reported Event|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
401489|NCT00489359|B3|Baseline|Total|Total of all reporting groups
401585|NCT00489476|E4|Reported Event|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose
Staccato Loxapine"
402987|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
401490|NCT00489359|B2|Baseline|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401491|NCT00489359|B1|Baseline|Pemetrexed/Carboplatin Phase 1|Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
401492|NCT00489359|P2|Participant Flow|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401493|NCT00489359|P1|Participant Flow|Pemetrexed/Carboplatin Phase 1|Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
401494|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401495|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401496|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401497|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401498|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401499|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401500|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401501|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
401502|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
401503|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
401504|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
401586|NCT00489476|E3|Reported Event|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose
Staccato Loxapine"
401587|NCT00489476|E2|Reported Event|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose
Staccato Loxapine"
401505|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
401506|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401507|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
401508|NCT00489359|E7|Reported Event|Pemetrexed 500 + Carboplatin AUC 6 (Phase 2)|"Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion."
401509|NCT00489359|E6|Reported Event|Pemetrexed 900 + Carboplatin AUC 6 (Phase 1)|"Pemetrexed (900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion."
401510|NCT00489359|E5|Reported Event|Pemetrexed 800 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (800 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401511|NCT00489359|E4|Reported Event|Pemetrexed 700 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (700 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401512|NCT00489359|E3|Reported Event|Pemetrexed 600 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401513|NCT00489359|E2|Reported Event|Pemetrexed 600 + Carboplatin AUC 5 (Phase 1)|Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401514|NCT00489359|E1|Reported Event|Pemetrexed 500 + Carboplatin AUC 5 (Phase 1)|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
401515|NCT00489411|B3|Baseline|Total|Total of all reporting groups
401516|NCT00489411|B2|Baseline|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401517|NCT00489411|B1|Baseline|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401518|NCT00489411|P2|Participant Flow|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401519|NCT00489411|P1|Participant Flow|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401588|NCT00489476|E1|Reported Event|Staccato Placebo|"Staccato Placebo, 0 mg
Staccato Placebo: Placebo aerosol inhalation (0mg)"
401589|NCT00489489|B4|Baseline|Total|Total of all reporting groups
402988|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
401520|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401521|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401522|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401523|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401524|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401525|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401526|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401527|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401528|NCT00489411|E2|Reported Event|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401529|NCT00489411|E1|Reported Event|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
401530|NCT00489424|B4|Baseline|Total|Total of all reporting groups
401531|NCT00489424|B3|Baseline|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
402989|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
401532|NCT00489424|B2|Baseline|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401533|NCT00489424|B1|Baseline|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401534|NCT00489424|P3|Participant Flow|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401535|NCT00489424|P2|Participant Flow|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401536|NCT00489424|P1|Participant Flow|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401537|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401538|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401539|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401540|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401541|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401542|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401543|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401544|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401545|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401546|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401547|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401548|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401549|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401590|NCT00489489|B3|Baseline|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401550|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401551|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401552|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401553|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401554|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401555|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401556|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401557|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401558|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401559|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401560|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401561|NCT00489424|E3|Reported Event|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401562|NCT00489424|E2|Reported Event|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401563|NCT00489424|E1|Reported Event|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
401564|NCT00489476|B5|Baseline|Total|Total of all reporting groups
401565|NCT00489476|B4|Baseline|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose
Staccato Loxapine"
401566|NCT00489476|B3|Baseline|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose
Staccato Loxapine"
401567|NCT00489476|B2|Baseline|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose
Staccato Loxapine"
401568|NCT00489476|B1|Baseline|Staccato Placebo|"Staccato Placebo, 0 mg
Staccato Placebo: Placebo aerosol inhalation (0mg)"
401569|NCT00489476|P4|Participant Flow|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose
Staccato Loxapine"
401570|NCT00489476|P3|Participant Flow|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose
Staccato Loxapine"
401571|NCT00489476|P2|Participant Flow|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose
Staccato Loxapine"
401572|NCT00489476|P1|Participant Flow|Staccato Placebo|"Staccato Placebo, 0 mg
Staccato Placebo: Placebo aerosol inhalation (0mg)"
401573|NCT00489476|O4|Outcome|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose
Staccato Loxapine"
401574|NCT00489476|O3|Outcome|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose
Staccato Loxapine"
401575|NCT00489476|O2|Outcome|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose
Staccato Loxapine"
401576|NCT00489476|O1|Outcome|Staccato Placebo|"Staccato Placebo, 0 mg
Staccato Placebo: Placebo aerosol inhalation (0mg)"
401577|NCT00489476|O4|Outcome|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose
Staccato Loxapine"
402990|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
401593|NCT00489489|P3|Participant Flow|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401594|NCT00489489|P2|Participant Flow|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401595|NCT00489489|P1|Participant Flow|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401596|NCT00489489|O2|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
401597|NCT00489489|O1|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks
401598|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401599|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401600|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401601|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401602|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401603|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401604|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401605|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401606|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401607|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401608|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401609|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401610|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401611|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401612|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401613|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401614|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401615|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401616|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401617|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401618|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
401619|NCT00489489|E3|Reported Event|Teriflunomide 14 mg + + IFN-β|Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
401620|NCT00489489|E2|Reported Event|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks
401621|NCT00489489|E1|Reported Event|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with IFN-β for 24 weeks
401622|NCT00489541|B3|Baseline|Total|Total of all reporting groups
401623|NCT00489541|B2|Baseline|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
401624|NCT00489541|B1|Baseline|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
401625|NCT00489541|P2|Participant Flow|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
401626|NCT00489541|P1|Participant Flow|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
401627|NCT00489541|O2|Outcome|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
401628|NCT00489541|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
401629|NCT00489541|O2|Outcome|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
401630|NCT00489541|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
401631|NCT00489541|E2|Reported Event|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
401632|NCT00489541|E1|Reported Event|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
401633|NCT00489554|B1|Baseline|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401634|NCT00489554|P1|Participant Flow|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401685|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401635|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
403453|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
401636|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401637|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401638|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401639|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401640|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401641|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401642|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401643|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401644|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401645|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401646|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401647|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401648|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401649|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401650|NCT00489554|E1|Reported Event|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
401651|NCT00479765|B1|Baseline|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel
OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
401652|NCT00479765|P1|Participant Flow|OncoGel|"OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel
OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
401653|NCT00479765|O1|Outcome|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel
OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
401654|NCT00479765|E1|Reported Event|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel
OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
401655|NCT00479856|B1|Baseline|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:
(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
401656|NCT00479856|P1|Participant Flow|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:
(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
401657|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:
(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
401658|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:
(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
402991|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
401686|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401659|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:
(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
401660|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:
(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
401661|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:
(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
401662|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:
(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
401663|NCT00479856|E1|Reported Event|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:
(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
401664|NCT00479882|B5|Baseline|Total|Total of all reporting groups
401665|NCT00479882|B4|Baseline|Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
401666|NCT00479882|B3|Baseline|Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg|After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
401667|NCT00479882|B2|Baseline|Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
401668|NCT00479882|B1|Baseline|Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg|After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
401669|NCT00479882|P4|Participant Flow|Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
401670|NCT00479882|P3|Participant Flow|Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg|After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
401671|NCT00479882|P2|Participant Flow|Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
401672|NCT00479882|P1|Participant Flow|Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg|After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
401673|NCT00479882|O4|Outcome|MK-0524A 1 g + Simvastatin 40 mg|Participants who received MK-0524A 1g+Simvastatin 40mg for 4 weeks in Period I regardless of randomly assigned sequence.
401674|NCT00479882|O3|Outcome|MK-0524B 0.9 g/40 mg|Participants who received MK-0524B 0.9g/40mg for 4 weeks in Period I regardless of randomly assigned sequence.
401675|NCT00479882|O2|Outcome|MK-0524A 1g+Simvastatin 10mg|Participants who received MK-0524A 1g+Simvastatin 10mg for 4 weeks in Period I regardless of randomly assigned sequence.
401676|NCT00479882|O1|Outcome|MK-0524B 0.9g/10mg|Participants who received MK-0524B 0.9g/10mg for 4 weeks in Period I regardless of randomly assigned sequence.
401677|NCT00479882|O4|Outcome|MK-0524A 1 g + Simvastatin 40 mg|Participants who received MK-0524A 1g+Simvastatin 40mg for 4 weeks in Period I regardless of randomly assigned sequence.
401678|NCT00479882|O3|Outcome|MK-0524B 0.9 g/40 mg|Participants who received MK-0524B 0.9g/40mg for 4 weeks in Period I regardless of randomly assigned sequence.
401679|NCT00479882|O2|Outcome|MK-0524A 1g+Simvastatin 10mg|Participants who received MK-0524A 1g+Simvastatin 10mg for 4 weeks in Period I regardless of randomly assigned sequence.
401680|NCT00479882|O1|Outcome|MK-0524B 0.9g/10mg|Participants who received MK-0524B 0.9g/10mg for 4 weeks in Period I regardless of randomly assigned sequence.
401681|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401682|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401683|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401684|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
402992|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
401687|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401688|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401689|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401690|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401691|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401692|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401693|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401694|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401695|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401696|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401697|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401698|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401699|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401700|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401701|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401702|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401703|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401704|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401705|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401706|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401707|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401708|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401709|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401710|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401711|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401712|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401713|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401714|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401715|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401716|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401717|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401718|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401719|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401720|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401721|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401722|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401723|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401724|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401725|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401726|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401727|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
402993|NCT00490945|O1|Outcome|Placebo|Randomized to Placebo
401728|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401729|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401730|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401731|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401732|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401733|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401734|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401735|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401736|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401737|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401738|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401739|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401740|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401741|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401742|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401743|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401744|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401745|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401746|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401747|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401748|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401749|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401750|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401751|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401752|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401753|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401754|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401755|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401756|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401757|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401758|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401759|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401760|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401761|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401762|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401763|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401764|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401765|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401766|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401767|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401768|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401769|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401770|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401815|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401771|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401772|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401773|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401774|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401775|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401776|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401777|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401778|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401779|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
401780|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401781|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401782|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
401783|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
401784|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401785|NCT00479882|O4|Outcome|MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
401786|NCT00479882|O3|Outcome|MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
401787|NCT00479882|O2|Outcome|MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
401788|NCT00479882|O1|Outcome|MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
401789|NCT00479882|O4|Outcome|MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
401790|NCT00479882|O3|Outcome|MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
401791|NCT00479882|O2|Outcome|MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
401792|NCT00479882|O1|Outcome|MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
401793|NCT00479882|E8|Reported Event|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
401794|NCT00479882|E7|Reported Event|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
401795|NCT00479882|E6|Reported Event|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
401796|NCT00479882|E5|Reported Event|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
401797|NCT00479882|E4|Reported Event|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
401798|NCT00479882|E3|Reported Event|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Period III
401799|NCT00479882|E2|Reported Event|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Periods I/II
401800|NCT00479882|E1|Reported Event|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
401801|NCT00480324|B3|Baseline|Total|Total of all reporting groups
401802|NCT00480324|B2|Baseline|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401803|NCT00480324|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401804|NCT00480324|P2|Participant Flow|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401805|NCT00480324|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401806|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401807|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401808|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401809|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401810|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401811|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401812|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401813|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401814|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401816|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401817|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401818|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401819|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401820|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401821|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401822|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401823|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401824|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401825|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401826|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401827|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401828|NCT00480324|E2|Reported Event|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
401829|NCT00480324|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
401830|NCT00480493|B3|Baseline|Total|Total of all reporting groups
401831|NCT00480493|B2|Baseline|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
401832|NCT00480493|B1|Baseline|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
401833|NCT00480493|P2|Participant Flow|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
401834|NCT00480493|P1|Participant Flow|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
401835|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|
401836|NCT00480493|O1|Outcome|Parent Contact Control Arm|
401837|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|
401838|NCT00480493|O1|Outcome|Parent Contact Control Arm|
401839|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|Parent mentor experimental arm had an assigned experienced parent raising a child with type 1 diabetes. The experienced parent mentor contacted the parent and negotiated the intervention dose, depending on need.
401840|NCT00480493|O1|Outcome|Parent Contact Control Arm|Parent contact control arm had a phone number only to call an experienced parent raising a child with type 1 diabetes to discuss support. The experienced parent contact did not initiate the contact.
401841|NCT00480493|E2|Reported Event|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
401842|NCT00480493|E1|Reported Event|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
401843|NCT00480532|B5|Baseline|Total|Total of all reporting groups
401844|NCT00480532|B4|Baseline|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
401845|NCT00480532|B3|Baseline|Placebo (Prevention)|Placebo for prevention portion of the study
401846|NCT00480532|B2|Baseline|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
401847|NCT00480532|B1|Baseline|Placebo (Treatment)|Placebo (for treatment portion of the study)
401848|NCT00480532|P4|Participant Flow|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
401849|NCT00480532|P3|Participant Flow|Placebo (Prevention)|Placebo for prevention portion of the study
401850|NCT00480532|P2|Participant Flow|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
401851|NCT00480532|P1|Participant Flow|Placebo (Treatment)|Placebo (for treatment portion of the study)
401852|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
401853|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
401854|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
401855|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
401856|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
401857|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
401858|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
401859|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
401860|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
401861|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
401862|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
401863|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
401864|NCT00480532|E4|Reported Event|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
401865|NCT00480532|E3|Reported Event|Placebo (Prevention)|Placebo for prevention portion of the study
401866|NCT00480532|E2|Reported Event|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
401867|NCT00480532|E1|Reported Event|Placebo (Treatment)|Placebo (for treatment portion of the study)
401868|NCT00480636|B1|Baseline|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
401869|NCT00480636|P1|Participant Flow|Dalteparin|Dalteparin 200 International Units per kilogram (IU/kg) total body weight subcutaneously (SC) once daily (QD) for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
402224|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
401870|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
401871|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
401872|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
401873|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
401874|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
401875|NCT00480636|E1|Reported Event|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
401876|NCT00480740|B4|Baseline|Total|Total of all reporting groups
401877|NCT00480740|B3|Baseline|Fontan Physiology|
401878|NCT00480740|B2|Baseline|Cardiac Transplant|
401879|NCT00480740|B1|Baseline|Normal Physiology|
401880|NCT00480740|P3|Participant Flow|Fontan Physiology|diagnostic cardiac catheterization in children with a transplanted ventricle
401881|NCT00480740|P2|Participant Flow|Cardiac Transplant|diagnostic cardiac catheterization in children with a transplanted heart
401882|NCT00480740|P1|Participant Flow|Normal Physiology|diagnostic cardiac catheterization in children with normal cardiac physiology
401883|NCT00480740|O3|Outcome|Fontan Physiology|diagnostic cardiac catheterization in children with a transplanted ventricle
401884|NCT00480740|O2|Outcome|Cardiac Transplant|diagnostic cardiac catheterization in children with a transplanted heart
401885|NCT00480740|O1|Outcome|Normal Physiology|diagnostic cardiac catheterization in children with normal cardiac physiology
401886|NCT00480740|E3|Reported Event|Normal Physiology|"control group
Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization"
401887|NCT00480740|E2|Reported Event|Fontan Procedure|Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
401888|NCT00480740|E1|Reported Event|Cardiac Transplant|Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
401889|NCT00480779|B3|Baseline|Total|Total of all reporting groups
401890|NCT00480779|B2|Baseline|GLB DVD|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
401891|NCT00480779|B1|Baseline|GLB Group|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
401892|NCT00480779|P2|Participant Flow|GLB DVD|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
401893|NCT00480779|P1|Participant Flow|GLB Group|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
401894|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
401920|NCT00480857|E1|Reported Event|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
401921|NCT00480987|B1|Baseline|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
401922|NCT00480987|P1|Participant Flow|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
401895|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
401896|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
401897|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
401898|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
401899|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
401900|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
401901|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
401923|NCT00480987|O1|Outcome|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
401924|NCT00480987|E1|Reported Event|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
401925|NCT00481195|B3|Baseline|Total|Total of all reporting groups
402060|NCT00481507|O1|Outcome|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
402223|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
401902|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
401903|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
401904|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
401905|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
401906|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
401907|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
401908|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
401926|NCT00481195|B2|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401909|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
401910|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
401911|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
401912|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
401913|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
401914|NCT00480779|E2|Reported Event|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD:The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
401915|NCT00480779|E1|Reported Event|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
401916|NCT00480857|B1|Baseline|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
401917|NCT00480857|P1|Participant Flow|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
401918|NCT00480857|O1|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
401919|NCT00480857|O1|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
401927|NCT00481195|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401928|NCT00481195|P2|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401929|NCT00481195|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401930|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401931|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401932|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401933|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401934|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401935|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
402047|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
402048|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
402211|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
401936|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401937|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401938|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401939|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401940|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401941|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401942|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401943|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401944|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
402049|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
402050|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
402994|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
401945|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401946|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401947|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401948|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401949|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401950|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401951|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401952|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401953|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
402051|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
402052|NCT00481351|E2|Reported Event|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
402212|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
401954|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401955|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401956|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401957|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401958|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401959|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401960|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401961|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401962|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
402053|NCT00481351|E1|Reported Event|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
402054|NCT00481507|B3|Baseline|Total|Total of all reporting groups
402213|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
401963|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401964|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401965|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401966|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401967|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401968|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401969|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401970|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401971|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
402055|NCT00481507|B2|Baseline|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
402995|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
401972|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401973|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401974|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401975|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401976|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401977|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401978|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401979|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401980|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
402056|NCT00481507|B1|Baseline|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
402214|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402215|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
401981|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401982|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401983|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401984|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401985|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401986|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401987|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401988|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401989|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
402057|NCT00481507|P2|Participant Flow|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
402996|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
401990|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401991|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401992|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401993|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401994|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401995|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401996|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
401997|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
401998|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
402058|NCT00481507|P1|Participant Flow|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
402216|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402217|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
401999|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
402000|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
402001|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
402002|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
402003|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
402004|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
402005|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
402006|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
402007|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
402059|NCT00481507|O2|Outcome|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
402997|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162**
402008|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
402009|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
402010|NCT00481195|E2|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
402011|NCT00481195|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
402012|NCT00481247|B3|Baseline|Total|Total of all reporting groups
402013|NCT00481247|B2|Baseline|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
402014|NCT00481247|B1|Baseline|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402015|NCT00481247|P2|Participant Flow|Imatinib|Tablets, oral, imatinib 400mg once daily (QD)
402016|NCT00481247|P1|Participant Flow|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402017|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
402018|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402019|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
402020|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402021|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
402022|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402023|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
402024|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402025|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
402026|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402027|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
402028|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402029|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
402030|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402031|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
402032|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402033|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
402034|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402035|NCT00481247|E2|Reported Event|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
402036|NCT00481247|E1|Reported Event|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
402037|NCT00481351|B3|Baseline|Total|Total of all reporting groups
402038|NCT00481351|B2|Baseline|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
402039|NCT00481351|B1|Baseline|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
402040|NCT00481351|P2|Participant Flow|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
402041|NCT00481351|P1|Participant Flow|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
402042|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
402043|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
402044|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
402045|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
402046|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
402061|NCT00481507|E2|Reported Event|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
402062|NCT00481507|E1|Reported Event|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
402063|NCT00481676|B3|Baseline|Total|Total of all reporting groups
402064|NCT00481676|B2|Baseline|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402065|NCT00481676|B1|Baseline|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402066|NCT00481676|P2|Participant Flow|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402067|NCT00481676|P1|Participant Flow|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402068|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402069|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402070|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402071|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402072|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402073|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402074|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402075|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402076|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402077|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402078|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402079|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402080|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402081|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402082|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402083|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402084|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402085|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402086|NCT00481676|E2|Reported Event|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402087|NCT00481676|E1|Reported Event|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
402088|NCT00481767|B3|Baseline|Total|Total of all reporting groups
402089|NCT00481767|B2|Baseline|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402090|NCT00481767|B1|Baseline|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402091|NCT00481767|P2|Participant Flow|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402092|NCT00481767|P1|Participant Flow|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402093|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402094|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402095|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402096|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402097|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402098|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402099|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402100|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402101|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402102|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402103|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402104|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402105|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402106|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402107|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402108|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402109|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402110|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402111|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402112|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402113|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402114|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402115|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402116|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402117|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402118|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402119|NCT00481767|E2|Reported Event|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402120|NCT00481767|E1|Reported Event|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
402121|NCT00481845|B3|Baseline|Total|Total of all reporting groups
402122|NCT00481845|B2|Baseline|Anastrozole|Anastrozole as neoadjuvant therapy
402123|NCT00481845|B1|Baseline|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
402124|NCT00481845|P2|Participant Flow|Anastrozole|Anastrozole as neoadjuvant therapy
402125|NCT00481845|P1|Participant Flow|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
402126|NCT00481845|O2|Outcome|Anastrozole|Anastrozole as neoadjuvant therapy
402127|NCT00481845|O1|Outcome|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
402128|NCT00481845|O2|Outcome|Anastrozole|Anastrozole as neoadjuvant therapy
402129|NCT00481845|O1|Outcome|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
402130|NCT00481845|E2|Reported Event|Anastrozole|Anastrozole as neoadjuvant therapy
402131|NCT00481845|E1|Reported Event|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
402132|NCT00481871|B6|Baseline|Total|Total of all reporting groups
402133|NCT00481871|B5|Baseline|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
402134|NCT00481871|B4|Baseline|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
402135|NCT00481871|B3|Baseline|Phase 1 - Group C|Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
402136|NCT00481871|B2|Baseline|Phase 1 - Group B|Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
402137|NCT00481871|B1|Baseline|Phase 1 - Group A|Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
402138|NCT00481871|P5|Participant Flow|Phase 2 Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
402139|NCT00481871|P4|Participant Flow|Phase 2 Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
402140|NCT00481871|P3|Participant Flow|Phase 1 Group C - Dose Finding|Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
402141|NCT00481871|P2|Participant Flow|Phase 1 Group B - Dose Finding|Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
402142|NCT00481871|P1|Participant Flow|Phase 1 Group A - Dose Finding|Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
402143|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
402144|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
402145|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
402218|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402998|NCT00490945|O1|Outcome|Placebo*|Randomized to Placebo
402146|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
402147|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
402148|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
402149|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
402150|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
402151|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
402152|NCT00481871|E3|Reported Event|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
402153|NCT00481871|E2|Reported Event|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
402154|NCT00481871|E1|Reported Event|Phase 1|Patients that received at least one dose of pralatrexate in the Phase 1 portion of the study
402155|NCT00481988|B3|Baseline|Total|Total of all reporting groups
402156|NCT00481988|B2|Baseline|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
402157|NCT00481988|B1|Baseline|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
402158|NCT00481988|P2|Participant Flow|Sham Iomed II Phoresor Transcranial Direct Current Stimulation|The sham group receives sham stimulation for the first two weeks of the study followed by active treatment in the second two weeks. To mimic the sensation of active treatment and maintain the blind of the study, in the sham arm the Iomed II Phoresor constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
402159|NCT00481988|P1|Participant Flow|Iomed II Phoresor Transcranial Direct Current Stimulation|The active group of patients will receive active Iomed II Phoresor transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation.
402160|NCT00481988|O2|Outcome|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
402161|NCT00481988|O1|Outcome|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
402162|NCT00481988|O2|Outcome|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
402163|NCT00481988|O1|Outcome|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
402164|NCT00481988|E2|Reported Event|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
402165|NCT00481988|E1|Reported Event|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
402166|NCT00482014|B5|Baseline|Total|Total of all reporting groups
402167|NCT00482014|B4|Baseline|Pemetrexed + Cisplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402168|NCT00482014|B3|Baseline|Pemetrexed + Carboplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402219|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402999|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
402169|NCT00482014|B2|Baseline|Pemetrexed + Cisplatin (Study Phase 1)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402170|NCT00482014|B1|Baseline|Pemetrexed + Carboplatin (Study Phase 1)|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402171|NCT00482014|P4|Participant Flow|Pemetrexed + Cisplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402172|NCT00482014|P3|Participant Flow|Pemetrexed + Carboplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402173|NCT00482014|P2|Participant Flow|Pemetrexed + Cisplatin (Study Phase 1)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402174|NCT00482014|P1|Participant Flow|Pemetrexed + Carboplatin (Study Phase 1)|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402175|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402176|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 Gray (Gy) total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402177|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402178|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402179|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402180|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 Gray (Gy) total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402181|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402182|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402183|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402220|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402221|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402222|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402184|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402185|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402186|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402187|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402188|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402189|NCT00482014|O1|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402190|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402191|NCT00482014|E4|Reported Event|Phase 2: Pemetrexed + Cisplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402192|NCT00482014|E3|Reported Event|Phase 2: Pemetrexed + Carboplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402193|NCT00482014|E2|Reported Event|Phase 1: Pemetrexed + Cisplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Grays (Gy) total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
402194|NCT00482014|E1|Reported Event|Phase 1: Pemetrexed + Carboplatin|"500 milligrams/meter squared (mg/m²) pemetrexed (pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.
Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
402195|NCT00482170|B3|Baseline|Total|Total of all reporting groups
402196|NCT00482170|B2|Baseline|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402197|NCT00482170|B1|Baseline|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402198|NCT00482170|P2|Participant Flow|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg prefilled syringe (PFS) s.c. twice-weekly for 12 weeks.
402199|NCT00482170|P1|Participant Flow|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 milligram (mg) auto-injector (AI) subcutaneously (s.c.) twice-weekly for 12 weeks.
402200|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402201|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402202|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402203|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402204|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402205|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402206|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402207|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402208|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402209|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402210|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402225|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402226|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402227|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402228|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402229|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402230|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402231|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402232|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402233|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402234|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402235|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402236|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402237|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402238|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402239|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402240|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402241|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402242|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402243|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402244|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402245|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402246|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402247|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402248|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402249|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402250|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402251|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402252|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402253|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402254|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402255|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402256|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402257|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402258|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402259|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402260|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402261|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402262|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402263|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402264|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402265|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402266|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402267|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402268|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402269|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402270|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402271|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402272|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402273|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402274|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402275|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402276|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
403000|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
402277|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402278|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402279|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402280|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402281|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402282|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402283|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402284|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402285|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402286|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402287|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402288|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402289|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402290|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402291|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402292|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402293|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402294|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402295|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402296|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402297|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402298|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402299|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402300|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402301|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402302|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402303|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402304|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402305|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402306|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402307|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402308|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402309|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402310|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402311|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402312|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402313|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402314|NCT00482170|E2|Reported Event|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
402315|NCT00482170|E1|Reported Event|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
402316|NCT00482274|B1|Baseline|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
402317|NCT00482274|P1|Participant Flow|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
402318|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
402319|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
402320|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
402321|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
402322|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
402323|NCT00482274|E1|Reported Event|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
402324|NCT00482391|B1|Baseline|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
403007|NCT00490945|E2|Reported Event|10 mg VEC-162|Randomized to 10 mg VEC-162
402325|NCT00482391|P1|Participant Flow|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
402326|NCT00482391|O1|Outcome|Dose-dense Adjuvant/ Neoadjuvant Chemotherapy Regimen|
402327|NCT00482391|O1|Outcome|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
402328|NCT00482391|E1|Reported Event|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
402329|NCT00482547|B3|Baseline|Total|Total of all reporting groups
402330|NCT00482547|B2|Baseline|Silicone-coated Catheter|silicone elastomer-coated latex catheter
402331|NCT00482547|B1|Baseline|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
402332|NCT00482547|P2|Participant Flow|Silicone-coated Catheter|silicone elastomer-coated latex catheter
402333|NCT00482547|P1|Participant Flow|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
402334|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
402335|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
402336|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
402337|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
402338|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
402339|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
402340|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
402341|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
402342|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
402343|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
402344|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
402345|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
402346|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
402347|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
402348|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
402349|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
402350|NCT00482547|E2|Reported Event|Silicone-coated Catheter|silicone elastomer-coated latex catheter
402351|NCT00482547|E1|Reported Event|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
402352|NCT00482612|B5|Baseline|Total|Total of all reporting groups
402353|NCT00482612|B4|Baseline|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
402354|NCT00482612|B3|Baseline|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
402355|NCT00482612|B2|Baseline|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
402356|NCT00482612|B1|Baseline|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
402357|NCT00482612|P4|Participant Flow|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
402358|NCT00482612|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
402359|NCT00482612|P2|Participant Flow|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
402360|NCT00482612|P1|Participant Flow|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
402361|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
402362|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
402363|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
402364|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
402365|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
402366|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
402367|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
402368|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
402369|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
402370|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
402371|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
402372|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
402373|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
402374|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
402375|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
402376|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
402377|NCT00482612|E8|Reported Event|Placebo Follow-up|After receiving placebo in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
402378|NCT00482612|E7|Reported Event|Esmirtazapine 4.5 mg Follow-up|After receiving 4.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
402379|NCT00482612|E6|Reported Event|Esmirtazapine 3.0 mg Folow-up|After receiving 3.0 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
402380|NCT00482612|E5|Reported Event|Esmirtazapine 1.5 mg Follow-up|After receiving 1.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
402381|NCT00482612|E4|Reported Event|Placebo In-treatment|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
402382|NCT00482612|E3|Reported Event|Esmirtazapine 4.5 mg In-treatment|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
402383|NCT00482612|E2|Reported Event|Esmirtazapine 3.0 mg In-Treatment|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
402384|NCT00482612|E1|Reported Event|Esmirtazapine 1.5 mg In-treatment|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
402385|NCT00482625|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
erlotinib hydrochloride: Given PO
conventional surgery: Undergo pancreatectomy
immunohistochemistry staining method: Correlative studies
protein expression analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
402386|NCT00482625|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
erlotinib hydrochloride: Given PO
conventional surgery: Undergo pancreatectomy
immunohistochemistry staining method: Correlative studies
protein expression analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
402387|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
erlotinib hydrochloride: Given PO
conventional surgery: Undergo pancreatectomy
immunohistochemistry staining method: Correlative studies
protein expression analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
402388|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
erlotinib hydrochloride: Given PO
conventional surgery: Undergo pancreatectomy
immunohistochemistry staining method: Correlative studies
protein expression analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
402389|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
erlotinib hydrochloride: Given PO
conventional surgery: Undergo pancreatectomy
immunohistochemistry staining method: Correlative studies
protein expression analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
402419|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402390|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
erlotinib hydrochloride: Given PO
conventional surgery: Undergo pancreatectomy
immunohistochemistry staining method: Correlative studies
protein expression analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
402391|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
erlotinib hydrochloride: Given PO
conventional surgery: Undergo pancreatectomy
immunohistochemistry staining method: Correlative studies
protein expression analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
402392|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
erlotinib hydrochloride: Given PO
conventional surgery: Undergo pancreatectomy
immunohistochemistry staining method: Correlative studies
protein expression analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
402393|NCT00482625|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
erlotinib hydrochloride: Given PO
conventional surgery: Undergo pancreatectomy
immunohistochemistry staining method: Correlative studies
protein expression analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
402394|NCT00482703|B3|Baseline|Total|Total of all reporting groups
402395|NCT00482703|B2|Baseline|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
402396|NCT00482703|B1|Baseline|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
402397|NCT00482703|P2|Participant Flow|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
402398|NCT00482703|P1|Participant Flow|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
402399|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402400|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402401|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402402|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402403|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402404|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402405|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402406|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402407|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402408|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402409|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402410|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402411|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402412|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402413|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402414|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402415|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402416|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402417|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402418|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402420|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402421|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402422|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402423|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402424|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402425|NCT00482703|O6|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402426|NCT00482703|O5|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402427|NCT00482703|O4|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402428|NCT00482703|O3|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402429|NCT00482703|O2|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402430|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402431|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402432|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402433|NCT00482703|O6|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402434|NCT00482703|O5|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402435|NCT00482703|O4|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
402436|NCT00482703|O3|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402437|NCT00482703|O2|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402438|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
402439|NCT00482703|E3|Reported Event|Total|
402440|NCT00482703|E2|Reported Event|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
402441|NCT00482703|E1|Reported Event|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
402442|NCT00482729|B3|Baseline|Total|Total of all reporting groups
402443|NCT00482729|B2|Baseline|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402444|NCT00482729|B1|Baseline|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402445|NCT00482729|P2|Participant Flow|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402446|NCT00482729|P1|Participant Flow|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402447|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402491|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402492|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402448|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402449|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402450|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402451|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402452|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402453|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402454|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402455|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402456|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402457|NCT00482729|E2|Reported Event|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402458|NCT00482729|E1|Reported Event|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
402459|NCT00482911|B3|Baseline|Total|Total of all reporting groups
402460|NCT00482911|B2|Baseline|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
402461|NCT00482911|B1|Baseline|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
402462|NCT00482911|P2|Participant Flow|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
402463|NCT00482911|P1|Participant Flow|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
402464|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
402493|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402494|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402465|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
402466|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
402467|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
402468|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
402469|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
402470|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
402471|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
402472|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
402473|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
402474|NCT00482911|E2|Reported Event|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
402475|NCT00482911|E1|Reported Event|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
402476|NCT00483002|B1|Baseline|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
402477|NCT00483002|P1|Participant Flow|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
402478|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
402479|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
402480|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
402481|NCT00483002|E1|Reported Event|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
402482|NCT00483041|B3|Baseline|Total|Total of all reporting groups
402483|NCT00483041|B2|Baseline|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402484|NCT00483041|B1|Baseline|PLACEBO|Placebo administered as a single intravenous dose
402485|NCT00483041|P2|Participant Flow|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402486|NCT00483041|P1|Participant Flow|PLACEBO|Placebo administered as a single intravenous dose
402487|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402488|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402489|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402490|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402495|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402496|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402497|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402498|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402499|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402500|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402501|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402502|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402503|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402504|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402505|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402506|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402507|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402508|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402509|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402510|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402511|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402512|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
402513|NCT00483041|E2|Reported Event|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
402514|NCT00483041|E1|Reported Event|PLACEBO|Placebo administered as a single intravenous dose
402515|NCT00483119|B3|Baseline|Total|Total of all reporting groups
402516|NCT00483119|B2|Baseline|Group B|"IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
402517|NCT00483119|B1|Baseline|Group A|"IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
402518|NCT00483119|P2|Participant Flow|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
402519|NCT00483119|P1|Participant Flow|IVIg Alone|"IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
402520|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
402521|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
402522|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
402523|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
402524|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
402525|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
402526|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
402527|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
402528|NCT00483119|E2|Reported Event|Group B|"IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
402529|NCT00483119|E1|Reported Event|Group A|"IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
402530|NCT00483184|B4|Baseline|Total|Total of all reporting groups
402531|NCT00483184|B3|Baseline|3|(Veldona)1000 IU IFNα bid
402532|NCT00483184|B2|Baseline|2|(Veldona)500 IU IFNα bid
402533|NCT00483184|B1|Baseline|1|(placebo)0 IU IFN alpha
402534|NCT00483184|P3|Participant Flow|3|(Veldona)1000 IU IFNα bid
402535|NCT00483184|P2|Participant Flow|2|(Veldona)500 IU IFNα bid
402536|NCT00483184|P1|Participant Flow|1|(placebo)0 IU IFN alpha
402537|NCT00483184|O3|Outcome|3|(Veldona)1000 IU IFNα bid
402538|NCT00483184|O2|Outcome|2|(Veldona)500 IU IFNα bid
402539|NCT00483184|O1|Outcome|1|(placebo)0 IU IFN alpha
402540|NCT00483184|E3|Reported Event|3|(Veldona)1000 IU IFNα bid
402541|NCT00483184|E2|Reported Event|2|(Veldona)500 IU IFNα bid
402542|NCT00483184|E1|Reported Event|1|(placebo)0 IU IFN alpha
402543|NCT00483223|B1|Baseline|Single Arm|"Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
402544|NCT00483223|P1|Participant Flow|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
402578|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402545|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
402546|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
402547|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
402548|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
402549|NCT00483223|E1|Reported Event|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
402550|NCT00483262|B3|Baseline|Total|Total of all reporting groups
402551|NCT00483262|B2|Baseline|CCI779 and Bortezomib Phase II|CCI779 and Bortezomib Phase II part of this Phase I/II study
402552|NCT00483262|B1|Baseline|CCI779 and Bortezomib Phase I|CCI779 and Bortezomib Phase I part of this Phase I/II study.
402553|NCT00483262|P2|Participant Flow|CCI779 and Bortezomib Phase II|CCI779 and Bortezomib, Phase II part of this Phase I/II study
402554|NCT00483262|P1|Participant Flow|CCI779 and Bortezomib Phase I|CCI779 and Bortezomib, Phase I part of this Phase I/II study
402555|NCT00483262|O2|Outcome|CCI779 PFS Phase II|Progression-free survival results from the phase II part of the phase I/II CCI779 with velcade study.
402556|NCT00483262|O1|Outcome|CCI779 PFS Phase I|Progression-free survival results from the phase I part of the phase I/II CCI779 with velcade study.
402557|NCT00483262|O2|Outcome|CCI779 Response Phase II|Response of PR or better per the Blade criteria in phase II part of this phase I/II study of CCI779 and velcade
402558|NCT00483262|O1|Outcome|CCI779 Response Phase I|Response of PR or better per the Blade criteria in phase I part of this phase I/II study of CCI779 and velcade
402559|NCT00483262|O2|Outcome|CCI779 Toxicity Phase II|Toxicity of CCI779 and velcade in the phase II part of this phase I/II study. CTC criteria used
402560|NCT00483262|O1|Outcome|CCI779 Toxicity Phase I|Toxicity of CCI779 and velcade in the phase I part of this phase I/II study. CTC criteria used.
402561|NCT00483262|E2|Reported Event|Adverse Events CCI779 and Bortezomib Phase II|Adverse Events of CCI779 and Bortezomib in Phase II part of this Phase I/II study.
402562|NCT00483262|E1|Reported Event|Adverse Events CCI779 and Bortezomib Phase I|Adverse Events of CCI779 and Bortezomib in the phase I part of this phase I/II study.
402563|NCT00483327|B1|Baseline|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
402564|NCT00483327|P1|Participant Flow|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
402565|NCT00483327|O1|Outcome|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
402566|NCT00483327|O2|Outcome|Grade 3|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
402567|NCT00483327|O1|Outcome|Grade 1 or 2|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
402568|NCT00483327|O1|Outcome|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
402569|NCT00483327|E1|Reported Event|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
402570|NCT00483379|B3|Baseline|Total|Total of all reporting groups
402571|NCT00483379|B2|Baseline|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402572|NCT00483379|B1|Baseline|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402573|NCT00483379|P2|Participant Flow|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402574|NCT00483379|P1|Participant Flow|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402575|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402576|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402577|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
403001|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
402579|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402580|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402581|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402582|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402583|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402584|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402585|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402586|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402587|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402588|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402589|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402590|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402591|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402592|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402593|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402594|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402595|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402596|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402597|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402598|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402599|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402600|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402601|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402602|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402603|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402604|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402605|NCT00483379|E4|Reported Event|Extension: Alglucosidase Alfa 40 mg/kg Every Other Week|The extension period of the study allowed late-onset participants access to the same treatment they took in the treatment period until the product was commercially available.
402606|NCT00483379|E3|Reported Event|Extension: Alglucosidase Alfa 20 mg/kg Every Week|The extension period of the study allowed late-onset participants access to the same treatment they took in the treatment period until the product was commercially available.
402607|NCT00483379|E2|Reported Event|Treatment: Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
402608|NCT00483379|E1|Reported Event|Treatment: Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
402609|NCT00483405|B1|Baseline|Single Arm Trial|"Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
402610|NCT00483405|P1|Participant Flow|Single Arm Trial|"Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
402611|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
402684|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
402685|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
402612|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
402613|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
402614|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
402615|NCT00483405|E1|Reported Event|Single Arm Trial|"Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
402616|NCT00483496|B1|Baseline|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
402617|NCT00483496|P1|Participant Flow|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
402618|NCT00483496|O8|Outcome|Vehicle|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
402619|NCT00483496|O7|Outcome|TiO2Pig|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
402620|NCT00483496|O6|Outcome|TiO2 Micro|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
402621|NCT00483496|O5|Outcome|Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
402622|NCT00483496|O4|Outcome|TiO2Pig + TiO2Micro|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
402623|NCT00483496|O3|Outcome|TiO2 Micro + Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
402624|NCT00483496|O2|Outcome|Ti02Pig + Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
402625|NCT00483496|O1|Outcome|V0096|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
402626|NCT00483496|E1|Reported Event|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
402627|NCT00483548|B3|Baseline|Total|Total of all reporting groups
402628|NCT00483548|B2|Baseline|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402629|NCT00483548|B1|Baseline|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402630|NCT00483548|P2|Participant Flow|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402631|NCT00483548|P1|Participant Flow|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402632|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402633|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402634|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402635|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402636|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402637|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402686|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
402687|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
402638|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402639|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402640|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402641|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402642|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402643|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402644|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402645|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402646|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402647|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402648|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402649|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402650|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402651|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402652|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402653|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402654|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402655|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402656|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402657|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402658|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402688|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
403002|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
402659|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402660|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402661|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402662|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402663|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402664|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402665|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402666|NCT00483548|E2|Reported Event|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402667|NCT00483548|E1|Reported Event|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
402668|NCT00483574|B3|Baseline|Total|Total of all reporting groups
402669|NCT00483574|B2|Baseline|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
402670|NCT00483574|B1|Baseline|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
402671|NCT00483574|P2|Participant Flow|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
402672|NCT00483574|P1|Participant Flow|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
402673|NCT00483574|O2|Outcome|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months.
402674|NCT00483574|O1|Outcome|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMR+V: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months. (0.5 mL, intramuscular, respectively)
402675|NCT00483574|O2|Outcome|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
402676|NCT00483574|O1|Outcome|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
402677|NCT00483574|E2|Reported Event|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
402678|NCT00483574|E1|Reported Event|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
402679|NCT00489736|B3|Baseline|Total|Total of all reporting groups
402680|NCT00489736|B2|Baseline|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
402681|NCT00489736|B1|Baseline|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
402682|NCT00489736|P2|Participant Flow|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
402683|NCT00489736|P1|Participant Flow|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
402690|NCT00489736|E2|Reported Event|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
402691|NCT00489736|E1|Reported Event|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
402692|NCT00489853|B1|Baseline|Entire Study Population|Cross over study with 3 Arms. (1)Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily. (2)Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily. (3) Placebo, 1 inhalation twice daily
402693|NCT00489853|P3|Participant Flow|Placebo Then Formoterol Then Symbicort|Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402694|NCT00489853|P2|Participant Flow|Formoterol Then Symbicort Then Placebo|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
402695|NCT00489853|P1|Participant Flow|Symbicort Then Formoterol Then Placebo|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
402696|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402697|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402698|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402699|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402700|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402701|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402702|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402703|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402704|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402705|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402706|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402707|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402708|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402709|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402710|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402711|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402712|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402713|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402714|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402715|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402716|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402717|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402718|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402719|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402720|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402721|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402722|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402723|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402724|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402725|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402726|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402727|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402728|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402729|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402730|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402731|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402732|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402733|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402734|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402735|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402736|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402737|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402738|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402739|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402740|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402741|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402742|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402743|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402744|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402745|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402746|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402749|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402750|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402751|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402752|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402753|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402754|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402755|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402756|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402757|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402758|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402759|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402760|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402761|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402762|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402763|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402764|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402765|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402766|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402767|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402768|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402769|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402770|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402771|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402772|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402773|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402774|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402775|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402776|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402777|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402778|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402779|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402780|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402781|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402782|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402783|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
402784|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402785|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402786|NCT00489853|E3|Reported Event|Placebo|Placebo, 1 inhalation twice daily
402787|NCT00489853|E2|Reported Event|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
402788|NCT00489853|E1|Reported Event|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
402789|NCT00489866|B3|Baseline|Total|Total of all reporting groups
402790|NCT00489866|B2|Baseline|Placebo|Identical to Aripiprazole
402791|NCT00489866|B1|Baseline|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
402792|NCT00489866|P2|Participant Flow|Placebo|Identical to Aripiprazole
402793|NCT00489866|P1|Participant Flow|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
402794|NCT00489866|O2|Outcome|Depression Symptoms Placebo Treated Group|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression.
402795|NCT00489866|O1|Outcome|Depression Symptoms Aripiprazole Treated Group|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression.
402796|NCT00489866|O2|Outcome|Resilience Symptoms PlaceboTreated Group|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
402797|NCT00489866|O1|Outcome|Resilience Symptoms Aripiprazole Treated Group|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
402798|NCT00489866|O2|Outcome|Psychotic Symptoms Placebo Treated Group|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.
403003|NCT00490945|O1|Outcome|Placebo|Randomized to Placebo
402799|NCT00489866|O1|Outcome|Psychotic Symptoms Aripiprazole Treated Group|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.
402800|NCT00489866|O2|Outcome|Cognitive Symptoms PlaceboTreated Group|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
402801|NCT00489866|O1|Outcome|Cognitive Symptoms Aripiprazole Treated Group|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
402802|NCT00489866|O2|Outcome|PTSD Symptoms Placebo Treated Group|The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
402803|NCT00489866|O1|Outcome|PTSD Symptoms Aripiprazole Treated Group|The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
402804|NCT00489866|E2|Reported Event|Placebo|Identical to Aripiprazole
402805|NCT00489866|E1|Reported Event|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
402806|NCT00490646|B3|Baseline|Total|Total of all reporting groups
402807|NCT00490646|B2|Baseline|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402808|NCT00490646|B1|Baseline|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402809|NCT00490646|P2|Participant Flow|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402810|NCT00490646|P1|Participant Flow|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402811|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402812|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402813|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402814|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402815|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402816|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402817|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402818|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402819|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402820|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402821|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402822|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
403004|NCT00490945|E5|Reported Event|100 mg VEC-162|Randomized to 100 mg VEC-162
403005|NCT00490945|E4|Reported Event|50 mg VEC-162|Randomized to 50 mg VEC-162
402823|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402824|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402825|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402826|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402827|NCT00490646|E2|Reported Event|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402828|NCT00490646|E1|Reported Event|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
402829|NCT00490698|B1|Baseline|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
402830|NCT00490698|P1|Participant Flow|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
402831|NCT00490698|O1|Outcome|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
402832|NCT00490698|E1|Reported Event|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
402833|NCT00490724|B4|Baseline|Total|Total of all reporting groups
402834|NCT00490724|B3|Baseline|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402835|NCT00490724|B2|Baseline|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402836|NCT00490724|B1|Baseline|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402837|NCT00490724|P3|Participant Flow|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402838|NCT00490724|P2|Participant Flow|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402839|NCT00490724|P1|Participant Flow|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402840|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402841|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402842|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402843|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402844|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402845|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402846|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402847|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402848|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402849|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402850|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402851|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402852|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402853|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402854|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402855|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402856|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402857|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402858|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402859|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402860|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402861|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402862|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402863|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402864|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402865|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402866|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402867|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402868|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402869|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402870|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402871|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402872|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402873|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402874|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402875|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402876|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402877|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402878|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402879|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402880|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402881|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402882|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402883|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402884|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402885|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402886|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402887|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402888|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402889|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402890|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402891|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402892|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402893|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402894|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402895|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402896|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402897|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402898|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402899|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402900|NCT00490724|E3|Reported Event|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
402901|NCT00490724|E2|Reported Event|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
402902|NCT00490724|E1|Reported Event|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
402903|NCT00490802|B3|Baseline|Total|Total of all reporting groups
402904|NCT00490802|B2|Baseline|Placebo|"Drug
Placebo Comparator : Placebo Comparator"
402905|NCT00490802|B1|Baseline|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
402906|NCT00490802|P2|Participant Flow|Placebo|Placebo Comparator : Placebo Comparator
402907|NCT00490802|P1|Participant Flow|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
402908|NCT00490802|O2|Outcome|Placebo|"Drug
Placebo Comparator : Placebo Comparator"
402909|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
402910|NCT00490802|O2|Outcome|Placebo|"Drug
Placebo Comparator : Placebo Comparator"
402911|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
402912|NCT00490802|O2|Outcome|Placebo|"Drug
Placebo Comparator : Placebo Comparator"
402913|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
402914|NCT00490802|O2|Outcome|Placebo|"Drug
Placebo Comparator : Placebo Comparator"
402915|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
402916|NCT00490802|O2|Outcome|Placebo|Placebo Comparator : Placebo Comparator
402917|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
402918|NCT00490802|E2|Reported Event|Placebo|"Drug
Placebo Comparator : Placebo Comparator"
402919|NCT00490802|E1|Reported Event|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
402920|NCT00490815|B3|Baseline|Total|Total of all reporting groups
402921|NCT00490815|B2|Baseline|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
402922|NCT00490815|B1|Baseline|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
402923|NCT00490815|P2|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant administered in one eye
402924|NCT00490815|P1|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant administered in one eye
402925|NCT00490815|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
402926|NCT00490815|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
402927|NCT00490815|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
402928|NCT00490815|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
402929|NCT00490815|E2|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
402930|NCT00490815|E1|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
402931|NCT00490841|B1|Baseline|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402932|NCT00490841|P1|Participant Flow|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402933|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402934|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402935|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402936|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402937|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402938|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402939|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
403006|NCT00490945|E3|Reported Event|20 mg VEC-162|Randomized to 20 mg VEC-162
402940|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402941|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402942|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402943|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402944|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402945|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
402946|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
402947|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
402948|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402949|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402950|NCT00490841|E1|Reported Event|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
402951|NCT00490919|B3|Baseline|Total|Total of all reporting groups
402952|NCT00490919|B2|Baseline|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
402953|NCT00490919|B1|Baseline|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
402954|NCT00490919|P3|Participant Flow|Double-blind Placebo TDS|Matching placebo transdermal patch (placebo TDS) 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
402955|NCT00490919|P2|Participant Flow|Double-blind BTDS 10 or 20|Buprenorphine transdermal patch (BTDS) 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
402956|NCT00490919|P1|Participant Flow|Open-label Run-in Period|"The open-label run-in period (< 27 days) (N = 1024 started) was designed to select subjects for randomization who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design).
Upon completion of the run-in period, 541 subjects were randomized and received treatment in the double-blind phase. Two subjects had no safety data after the randomization visit; therefore N = 539 for the randomized safety population."
402957|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
402958|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
402959|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
402960|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
402961|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
402962|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
402963|NCT00490919|E3|Reported Event|Open-label Run-in Period, BTDS 5, 10, 20|Open-label BTDS 5, 10, 20 applied for 7-day wear
402964|NCT00490919|E2|Reported Event|Double-blind Placebo TDS 10, 20|Matching placebo TDS 10 or 20 applied for 7-day wear
402965|NCT00490919|E1|Reported Event|Double-blind BTDS 10, 20|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear
402966|NCT00490945|B6|Baseline|Total|Total of all reporting groups
402967|NCT00490945|B5|Baseline|100 mg VEC-162|Randomized to 100 mg VEC-162
402968|NCT00490945|B4|Baseline|50 mg VEC-162|Randomized to 50 mg VEC-162
402969|NCT00490945|B3|Baseline|20 mg VEC-162|Randomized to 20 mg VEC-162
402970|NCT00490945|B2|Baseline|10 mg VEC-162|Randomized to 10 mg VEC-162
402971|NCT00490945|B1|Baseline|Placebo|Randomized to Placebo
402972|NCT00490945|P5|Participant Flow|100 mg VEC-162|Randomized to 100 mg VEC-162
402973|NCT00490945|P4|Participant Flow|50 mg VEC-162|Randomized to 50 mg VEC-162
402974|NCT00490945|P3|Participant Flow|20 mg VEC-162|Randomized to 20 mg VEC-162
402975|NCT00490945|P2|Participant Flow|10 mg VEC-162|Randomized to 10 mg VEC-162
402976|NCT00490945|P1|Participant Flow|Placebo|Randomized to Placebo
402977|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
402978|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
402979|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
402980|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
402981|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
402982|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
402983|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
403010|NCT00490971|B2|Baseline|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
403011|NCT00490971|B1|Baseline|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
403012|NCT00490971|P5|Participant Flow|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
403013|NCT00490971|P4|Participant Flow|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
403014|NCT00490971|P3|Participant Flow|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
403015|NCT00490971|P2|Participant Flow|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
403016|NCT00490971|P1|Participant Flow|Paliperidone Extented Release (ER)|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
403017|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
403018|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
403019|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
403020|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
403021|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
403022|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
403023|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
403024|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
403025|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
403026|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
403027|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
403028|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
403029|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
403030|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
403031|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
403032|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
403033|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
403034|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
403035|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
403036|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
403037|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
403038|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
403039|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
403040|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
403041|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
403042|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
403043|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
403044|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
403045|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
403046|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
403047|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
403048|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
403049|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
403050|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
403051|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
403052|NCT00490971|E5|Reported Event|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
403053|NCT00490971|E4|Reported Event|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
403054|NCT00490971|E3|Reported Event|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
403055|NCT00490971|E2|Reported Event|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
403056|NCT00490971|E1|Reported Event|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
403057|NCT00491075|B1|Baseline|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
403058|NCT00491075|P1|Participant Flow|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
403059|NCT00491075|O1|Outcome|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
403060|NCT00491075|E1|Reported Event|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
403061|NCT00491179|B3|Baseline|Total|Total of all reporting groups
403062|NCT00491179|B2|Baseline|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
403063|NCT00491179|B1|Baseline|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
403064|NCT00491179|P2|Participant Flow|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
403065|NCT00491179|P1|Participant Flow|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
403066|NCT00491179|O2|Outcome|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
403067|NCT00491179|O1|Outcome|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
403068|NCT00491179|O2|Outcome|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
403069|NCT00491179|O1|Outcome|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
403070|NCT00491179|E2|Reported Event|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
403071|NCT00491179|E1|Reported Event|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
403072|NCT00491244|B3|Baseline|Total|Total of all reporting groups
403073|NCT00491244|B2|Baseline|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
403074|NCT00491244|B1|Baseline|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
403075|NCT00491244|P2|Participant Flow|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
403076|NCT00491244|P1|Participant Flow|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
403077|NCT00491244|O2|Outcome|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
403078|NCT00491244|O1|Outcome|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
403079|NCT00491244|O2|Outcome|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
403080|NCT00491244|O1|Outcome|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
403081|NCT00491244|E2|Reported Event|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
403082|NCT00491244|E1|Reported Event|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
403083|NCT00491374|B3|Baseline|Total|Total of all reporting groups
403084|NCT00491374|B2|Baseline|Mometasone Furoate Nasal Spray|
403085|NCT00491374|B1|Baseline|Placebo|
403086|NCT00491374|P2|Participant Flow|Mometasone Furoate Nasal Spray|
403087|NCT00491374|P1|Participant Flow|Placebo|
403088|NCT00491374|O2|Outcome|Mometasone Furoate Nasal Spray|
403089|NCT00491374|O1|Outcome|Placebo|
403090|NCT00491374|E2|Reported Event|Mometasone Furoate Nasal Spray|
403091|NCT00491374|E1|Reported Event|Placebo|
403092|NCT00491387|B1|Baseline|Group 1|
403093|NCT00491387|P1|Participant Flow|Group 1|
403094|NCT00491387|O1|Outcome|Group 1|
403095|NCT00491387|E1|Reported Event|Group 1|
403096|NCT00491400|B3|Baseline|Total|Total of all reporting groups
403097|NCT00491400|B2|Baseline|Atorvastatin First|Atorvastatin First and Fenofibrate Second
403098|NCT00491400|B1|Baseline|Fenofibrate First|Fenofibrate First and Atorvastatin Second
403099|NCT00491400|P2|Participant Flow|Atorvastatin First|Participants randomized to receive atorvastatin first and fenofibrate second
403100|NCT00491400|P1|Participant Flow|Fenofibrate First|Participants randomized to receive fenofibrate first and atorvastatin second
403101|NCT00491400|O2|Outcome|Atorvastatin|Effect of atorvastatin treatment on lipid profile
403102|NCT00491400|O1|Outcome|Fenofibrate|Effect of fenofibrate treatment on lipid profile
403103|NCT00491400|O2|Outcome|Atorvastatin Treatment|Effect of atorvastatin on brachial artery FMD
403104|NCT00491400|O1|Outcome|Fenofibrate Treatment|Effect of fenofibrate on brachial artery FMD
403105|NCT00491400|E2|Reported Event|Atorvastatin First|Atorvastatin First and Fenofibrate Second
403106|NCT00491400|E1|Reported Event|Fenofibrate First|Fenofibrate First and Atorvastatin Second
403107|NCT00491504|B5|Baseline|Total|Total of all reporting groups
403108|NCT00491504|B4|Baseline|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
403109|NCT00491504|B3|Baseline|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
403110|NCT00491504|B2|Baseline|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
403111|NCT00491504|B1|Baseline|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
403112|NCT00491504|P4|Participant Flow|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
403113|NCT00491504|P3|Participant Flow|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
403114|NCT00491504|P2|Participant Flow|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
403115|NCT00491504|P1|Participant Flow|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
403116|NCT00491504|O2|Outcome|Placebo|All subjects who received 2 sprays each nostril of placebo on Day 1
403117|NCT00491504|O1|Outcome|Mometasone Furoate Nasal Spray 200 mcg|All subjects who received 2 sprays each nostril (total 200 mcg) of Mometasone Furoate Nasal Spray (MFNS) on Day 1
403118|NCT00491504|E4|Reported Event|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
403119|NCT00491504|E3|Reported Event|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
403120|NCT00491504|E2|Reported Event|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
403121|NCT00491504|E1|Reported Event|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
403122|NCT00491530|B4|Baseline|Total|Total of all reporting groups
403123|NCT00491530|B3|Baseline|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403124|NCT00491530|B2|Baseline|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403125|NCT00491530|B1|Baseline|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403126|NCT00491530|P3|Participant Flow|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403127|NCT00491530|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403128|NCT00491530|P1|Participant Flow|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403129|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403130|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403131|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403132|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403133|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403134|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403135|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403250|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
403136|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403137|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403138|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403139|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403140|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403141|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403142|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403143|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403144|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403145|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403146|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403147|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403148|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403149|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403150|NCT00491530|E3|Reported Event|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403151|NCT00491530|E2|Reported Event|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403152|NCT00491530|E1|Reported Event|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
403153|NCT00491556|B3|Baseline|Total|Total of all reporting groups
403154|NCT00491556|B2|Baseline|Standard Care Arm|"Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur.
Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years."
403155|NCT00491556|B1|Baseline|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
425879|NCT00542425|B3|Baseline|BA058 40 µg|
403156|NCT00491556|P2|Participant Flow|Standard Care (STAND)|Began HAART with ATV/r under the current DHHS guidelines (CD4+ T cells below 350 cells/mm3 or for other clinical concerns as outlined in the recommendations and as determined by the site clinician).
403157|NCT00491556|P1|Participant Flow|Experimental-Early Initiation of HAART (EXP)|Began HAART consisting of TDF/FTC/ATV/r (preferred regimen), AZT/3TC/ATV/r, or other recommended NRTI HAART backbone with ATV/r upon entry to study. Subjects who achieved virologic control by week 24 (viral load (VL) < 100 copies/ml) and maintained good control through 48 weeks then entered deintensification (de-int) to ATV/r alone and were followed for two years.
403158|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403159|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403160|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403161|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403162|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403163|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403164|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403165|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403233|NCT00491764|B2|Baseline|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
403234|NCT00491764|B1|Baseline|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
403166|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403167|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403168|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403169|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403170|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403171|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403172|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403173|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403174|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403235|NCT00491764|P6|Participant Flow|Placebo for 24 Weeks|Placebo for 24 weeks.
403236|NCT00491764|P5|Participant Flow|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
403175|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403176|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403177|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403178|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403179|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403180|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403181|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403182|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403183|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403237|NCT00491764|P4|Participant Flow|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
403184|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403185|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403186|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403187|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403188|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403189|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403190|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403191|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403238|NCT00491764|P3|Participant Flow|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
403239|NCT00491764|P2|Participant Flow|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
403240|NCT00491764|P1|Participant Flow|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
403241|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
403242|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
403243|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
403192|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403193|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403194|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403195|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403196|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403197|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403198|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403199|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403244|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
403245|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
403246|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
403247|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
403248|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
403249|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
403200|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403201|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403202|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403203|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403204|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403205|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403206|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403207|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403208|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
425880|NCT00542425|B2|Baseline|BA058 20 µg|
403209|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403210|NCT00491556|E2|Reported Event|Standard Care Arm|"Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur.
Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years."
403211|NCT00491556|E1|Reported Event|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
403212|NCT00491608|B1|Baseline|rThrombin|Participants who received at least 1 application of rThrombin during spinal or vascular surgery (arterial reconstruction or PAB,or AV vascular access procedure and had seronegative baseline rThrombin antibody status
403213|NCT00491608|P1|Participant Flow|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
403214|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
403215|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
403216|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
403217|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
403218|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
403219|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
403220|NCT00491608|E1|Reported Event|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
403221|NCT00491738|B3|Baseline|Total|Total of all reporting groups
403222|NCT00491738|B2|Baseline|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
403223|NCT00491738|B1|Baseline|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
403224|NCT00491738|P2|Participant Flow|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
403225|NCT00491738|P1|Participant Flow|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
403226|NCT00491738|O2|Outcome|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
403227|NCT00491738|O1|Outcome|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
403228|NCT00491764|B7|Baseline|Total|Total of all reporting groups
403229|NCT00491764|B6|Baseline|Placebo for 24 Weeks|Placebo for 24 weeks.
403230|NCT00491764|B5|Baseline|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
403231|NCT00491764|B4|Baseline|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
403232|NCT00491764|B3|Baseline|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
403251|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
403252|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
403253|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
403254|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
403255|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
403256|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
403257|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
403258|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
403259|NCT00491764|E6|Reported Event|Placebo for 24 Weeks|Placebo for 24 weeks
403260|NCT00491764|E5|Reported Event|Terbinafine 250 mg QD for 12 Weeks|Terbinafine 250 mg QD for 12 weeks
403261|NCT00491764|E4|Reported Event|Posaconazole 400 mg QD for 12 Weeks|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks
403262|NCT00491764|E3|Reported Event|Posaconazole 400 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks
403263|NCT00491764|E2|Reported Event|Posaconazole 200 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks
403264|NCT00491764|E1|Reported Event|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks
403265|NCT00491829|B4|Baseline|Total|Total of all reporting groups
403266|NCT00491829|B3|Baseline|Placebo|"placebo qhs
placebo: placebo"
403267|NCT00491829|B2|Baseline|Flibanserin 100mg|"100 mg qhs
BIMT 17 BS 100 mg: flibanserin 100mg"
403268|NCT00491829|B1|Baseline|Flibanserin 50mg|"50 mg qhs
BIMT 17 BS 50 mg: flibanserin 50 mg"
403269|NCT00491829|P3|Participant Flow|Placebo|"placebo qhs
placebo: placebo"
403270|NCT00491829|P2|Participant Flow|Flibanserin 100mg|"100 mg qhs
BIMT 17 BS 100 mg: flibanserin 100mg"
403271|NCT00491829|P1|Participant Flow|Flibanserin 50mg|"50 mg qhs
BIMT 17 BS 50 mg: flibanserin 50 mg"
403272|NCT00491829|O3|Outcome|Placebo|"placebo qhs
placebo: placebo"
403273|NCT00491829|O2|Outcome|Flibanserin 100mg|"100 mg qhs
BIMT 17 BS 100 mg: flibanserin 100mg"
403274|NCT00491829|O1|Outcome|Flibanserin 50mg|"50 mg qhs
BIMT 17 BS 50 mg: flibanserin 50 mg"
403275|NCT00491829|E3|Reported Event|Placebo|"placebo qhs
placebo: placebo"
403276|NCT00491829|E2|Reported Event|Flibanserin 100mg|"100 mg qhs
BIMT 17 BS 100 mg: flibanserin 100mg"
403277|NCT00491829|E1|Reported Event|Flibanserin 50mg|"50 mg qhs
BIMT 17 BS 50 mg: flibanserin 50 mg"
403278|NCT00491894|B1|Baseline|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
403279|NCT00491894|P1|Participant Flow|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
403280|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
403281|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
403282|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
403283|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
403284|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
403285|NCT00491894|E1|Reported Event|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
403286|NCT00492024|B3|Baseline|Total|Total of all reporting groups
403287|NCT00492024|B2|Baseline|Placebo|Matching placebo for 5 days
403288|NCT00492024|B1|Baseline|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
403289|NCT00492024|P2|Participant Flow|Placebo|Matching placebo for 5 days
403290|NCT00492024|P1|Participant Flow|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
403291|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
403292|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
403293|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
403294|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
403295|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
403296|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
403297|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
403298|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
403299|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
403300|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
403301|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
403302|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
403303|NCT00492024|E2|Reported Event|Placebo|Matching placebo for 5 days
403304|NCT00492024|E1|Reported Event|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
403305|NCT00492063|B5|Baseline|Total|Total of all reporting groups
403306|NCT00492063|B4|Baseline|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403307|NCT00492063|B3|Baseline|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403308|NCT00492063|B2|Baseline|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403309|NCT00492063|B1|Baseline|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403310|NCT00492063|P4|Participant Flow|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403311|NCT00492063|P3|Participant Flow|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403312|NCT00492063|P2|Participant Flow|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403313|NCT00492063|P1|Participant Flow|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403314|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403315|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403316|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403317|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403318|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403319|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403320|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403321|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403322|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403323|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403324|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403325|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403326|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403327|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403328|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403329|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403330|NCT00492063|E4|Reported Event|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403331|NCT00492063|E3|Reported Event|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403332|NCT00492063|E2|Reported Event|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
403333|NCT00492063|E1|Reported Event|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
403334|NCT00492089|B3|Baseline|Total|Total of all reporting groups
403335|NCT00492089|B2|Baseline|Crossover Arm B: Placebo First, Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A
403336|NCT00492089|B1|Baseline|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
403337|NCT00492089|P2|Participant Flow|Crossover Arm B: Placebo First, Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A.
403338|NCT00492089|P1|Participant Flow|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks.
403339|NCT00492089|O2|Outcome|Crossover Arm B: Placebo Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A
403340|NCT00492089|O1|Outcome|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
403341|NCT00492089|E2|Reported Event|Placebo|First Intervention Placebo IV (only) every 3 weeks for two courses
403342|NCT00492089|E1|Reported Event|Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
403343|NCT00492206|B1|Baseline|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
403344|NCT00492206|P1|Participant Flow|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
403386|NCT00492284|B4|Baseline|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403387|NCT00492284|B3|Baseline|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403451|NCT00492336|P2|Participant Flow|Inactive Pill|Treatment with Placebo
403454|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
403345|NCT00492206|O1|Outcome|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
403346|NCT00492206|O1|Outcome|Received Concurrent Radiotherapy + Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
403347|NCT00492206|O1|Outcome|Received ≥1 Dose of Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
403348|NCT00492206|O1|Outcome|Received ≥1 Dose of Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
403349|NCT00492206|E1|Reported Event|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
403350|NCT00492232|B3|Baseline|Total|Total of all reporting groups
403351|NCT00492232|B2|Baseline|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403352|NCT00492232|B1|Baseline|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403353|NCT00492232|P2|Participant Flow|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403354|NCT00492232|P1|Participant Flow|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403355|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403356|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403357|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403358|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403359|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403360|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403361|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403362|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403363|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403364|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403365|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403366|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403367|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403368|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403369|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403370|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403371|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403372|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403373|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403374|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403375|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403376|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403377|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403378|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403379|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403380|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403381|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403382|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403383|NCT00492232|E2|Reported Event|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
403384|NCT00492232|E1|Reported Event|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
403385|NCT00492284|B5|Baseline|Total|Total of all reporting groups
403388|NCT00492284|B2|Baseline|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403389|NCT00492284|B1|Baseline|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403390|NCT00492284|P4|Participant Flow|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403391|NCT00492284|P3|Participant Flow|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403392|NCT00492284|P2|Participant Flow|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403393|NCT00492284|P1|Participant Flow|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403394|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403395|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403396|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403397|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403398|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403399|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403400|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403401|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403402|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403403|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403404|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403405|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403406|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403407|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403408|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403409|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403410|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403411|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403412|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403413|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403414|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403415|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403416|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403417|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403418|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403419|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403420|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403421|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403422|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403423|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403424|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403425|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403426|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403427|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403428|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403429|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403430|NCT00492284|E4|Reported Event|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
403431|NCT00492284|E3|Reported Event|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
403432|NCT00492284|E2|Reported Event|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403433|NCT00492284|E1|Reported Event|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
403434|NCT00492297|B1|Baseline|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403435|NCT00492297|P1|Participant Flow|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid), the treatment continued until subjects had clear palliative benefit and were tolerating treatment well, or until progressive disease (PD) or death (if earlier) recorded up to 97 weeks. Subjects withdrawn from Sorafenib but with optional standard treatment entered Active Follow-up (AFU) period, which was 30(+4) days for subjects who had PD at the end of treatment; or until PD was documented for subjects who had complete response (CR) or partial response (PR) or stable disease (SD) at the end of treatment up to 97 weeks . Once subject progressed went into survival only follow-up which continued until death occurred up to 172 weeks.
403436|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403437|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403438|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403439|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403440|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403441|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403442|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403443|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403444|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403445|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403446|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403447|NCT00492297|E1|Reported Event|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
403448|NCT00492336|B3|Baseline|Total|Total of all reporting groups
403449|NCT00492336|B2|Baseline|Inactive Pill|Treatment with Placebo
403450|NCT00492336|B1|Baseline|Rasagiline|Treatment with Rasagiline
403457|NCT00492401|B1|Baseline|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
403458|NCT00492401|P1|Participant Flow|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
403459|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
403460|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
403461|NCT00492401|O2|Outcome|Non Responder|Any patient that did not achieve a CR (Complete Response), or Incomplete CR was categorized as a non responder.
403462|NCT00492401|O1|Outcome|Responders|Any patient that achieved a CR (Complete Response), or Incomplete CR was categorized as a responder.
403463|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
403464|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
403465|NCT00492401|E1|Reported Event|Treatment (Chemotherapy)|"Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
decitabine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
high performance liquid chromatography: Correlative studies
microarray analysis: Correlative studies
RNA analysis: Correlative studies
mass spectrometry: Correlative studies
DNA methylation analysis: Correlative studies
matrix-assisted laser desorption/ionization time of flight mass spectrometry: Correlative studies"
403466|NCT00492531|B3|Baseline|Total|Total of all reporting groups
403467|NCT00492531|B2|Baseline|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403468|NCT00492531|B1|Baseline|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403469|NCT00492531|P2|Participant Flow|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403470|NCT00492531|P1|Participant Flow|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403471|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403472|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403473|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403474|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403475|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403476|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403477|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403478|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403479|NCT00492531|E2|Reported Event|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403480|NCT00492531|E1|Reported Event|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
403481|NCT00492544|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
403482|NCT00492544|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
403483|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
403484|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
403485|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
403486|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
403487|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
403488|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
403489|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
425881|NCT00542425|B1|Baseline|Placebo|
403490|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
403491|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
403492|NCT00492544|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
403494|NCT00492557|B2|Baseline|Placebo+TIV Followed by 13vPnC 1 Month Later|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
403495|NCT00492557|B1|Baseline|13vPnC+TIV Followed by Placebo 1 Month Later|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
403496|NCT00492557|P2|Participant Flow|Placebo+TIV Followed by 13vPnC 1 Month Later|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
403497|NCT00492557|P1|Participant Flow|13vPnC+TIV Followed by Placebo 1 Month Later|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
403498|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
403499|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
403500|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
403501|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
403502|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
403503|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
403504|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
403505|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
403506|NCT00492557|O2|Outcome|Placebo+TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
403507|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
403508|NCT00492557|E4|Reported Event|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM [Placebo + TIV]).
403509|NCT00492557|E3|Reported Event|Placebo+TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
403510|NCT00492557|E2|Reported Event|Placebo|Single 0.5 mL 13vPnC placebo vaccine (administered 1 month after a single 0.5 mL 13vPnC and a single 0.5 mL TIV, IM [13vPnC + TIV]).
403511|NCT00492557|E1|Reported Event|13vPnC+TIV|Single 0.5 mL 13vPnC and a single 0.5 mL TIV, administered IM.
403512|NCT00492583|B3|Baseline|Total|Total of all reporting groups
403513|NCT00492583|B2|Baseline|Bifidobacterium Lactis (BB-12)|
403514|NCT00492583|B1|Baseline|Placebo|
403515|NCT00492583|P2|Participant Flow|Bifidobacterium Lactis (BB-12)|
403516|NCT00492583|P1|Participant Flow|Placebo|
403517|NCT00492583|O2|Outcome|Bifidobacterium Lactis (BB-12)|
403518|NCT00492583|O1|Outcome|Placebo|
403519|NCT00492583|E2|Reported Event|Bifidobacterium Lactis (BB-12)|
403520|NCT00492583|E1|Reported Event|Placebo|
403521|NCT00492622|B1|Baseline|All Participants|
403522|NCT00492622|P1|Participant Flow|All Study Participants|All participants were randomized to receive all formulations so baseline measures are reported for all participants.
403523|NCT00492622|O2|Outcome|All Study Subjects Delayed Release Arm|Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days
403524|NCT00492622|O1|Outcome|All Study Participants Immediate Release Arm|Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days
403525|NCT00492622|O2|Outcome|All Study Subjects Delayed Release Arm|Delayed-release omeprazole concentration: Delayed-release omeprazole 40 mg qam for 7 days
403526|NCT00492622|O1|Outcome|All Study Participants Immediate Release Arm|Immediate-release omeprazole concentration: Immediate-release omeprazole 40 mg qam for 7 days
403527|NCT00492622|O2|Outcome|All Study Subjects Delayed Release Arm|Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days
403528|NCT00492622|O1|Outcome|All Study Participants Immediate Release Arm|Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days
403529|NCT00492622|E2|Reported Event|Delayed Release Omeprazole|"subjects receive delayed release for 7 days then immediate release for 7 days
Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days"
403530|NCT00492622|E1|Reported Event|Immediate Release Fomeprazole|"subjects received immediate release for 7 days then delayed release for 7 days
Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days"
403531|NCT00492726|B3|Baseline|Total|Total of all reporting groups
403532|NCT00492726|B2|Baseline|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403533|NCT00492726|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403534|NCT00492726|P2|Participant Flow|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403535|NCT00492726|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403536|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403759|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403537|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403538|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403539|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403540|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403541|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403542|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403543|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403544|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403545|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403546|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403547|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403548|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403549|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403550|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403551|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403552|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403553|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403554|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403555|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403556|NCT00492726|E2|Reported Event|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
403557|NCT00492726|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
403558|NCT00492752|B3|Baseline|Total|Total of all reporting groups
403559|NCT00492752|B2|Baseline|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403560|NCT00492752|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403561|NCT00492752|P4|Participant Flow|B2) Placebo First - Then Open Label Sorafenib Treatment Phase|"Participants switched to Open-label Sorafenib treatment from Placebo after unblinding (August 19, 2007), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
Note: Safety Data of participants in the arm presented here are the data reported in Reporting Group (RG) 3."
403562|NCT00492752|P3|Participant Flow|B1) Placebo - no Open Label Phase|"Participants randomized to Sorafenib-matching Placebo until unblinding (August 19, 2007), Placebo tablets matching in appearance were orally administered twice daily (bid).
Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 2."
403563|NCT00492752|P2|Participant Flow|A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase|"Participants randomized to Sorafenib treatment from until unblinding (August 19, 2007) until end of trial (July 27, 2009), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 1."
403592|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403655|NCT00493012|E2|Reported Event|Placebo Comparator|A daily placebo oil is given for year
403615|NCT00492973|P1|Participant Flow|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.
active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
403564|NCT00492752|P1|Participant Flow|A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase|"Participants randomized to Sorafenib treatment until unblinding (August 19, 2007), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 1."
403565|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403566|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403567|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403568|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403569|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403570|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403571|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403572|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403573|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403574|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403575|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403576|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403577|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403578|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403579|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403580|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403581|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403582|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403583|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403584|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403585|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403586|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403587|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403588|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403589|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403590|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403591|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
403654|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403593|NCT00492752|E3|Reported Event|Placebo, Open Label Only (Participants Switched to Sorafenib)|Reporting Group 3 (RG 3): Participants switched to Open-label Sorafenib treatment from Placebo ( Data after unblinding [August 19, 2007] until end of this trial [July 27, 2009]). Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403594|NCT00492752|E2|Reported Event|Placebo, All (Double-Blind and Open Label Phase)|Reporting Group 2 (RG 2): All participants randomized to Sorafenib-matching Placebo (data from start of treatment until end of trial [July 27, 2009]). Treatment for Double-Blind phase (before unblinding [August 19, 2007]): Placebo tablets matching in appearance were orally administered twice daily (bid); Treatment for Open Label phase (after unblinding [August 19, 2007]): Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403595|NCT00492752|E1|Reported Event|Sorafenib, All (Double-Blind and Open Label Phase)|Reporting Group 1 (RG 1): All participants randomized to Sorafenib treatment (data from start of treatment until end of trial [July 27, 2009]). Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
403596|NCT00492856|B1|Baseline|Low and Intermediate Risk APL Patients|All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses). If CRm, patients randomized to either (1) maintenance: ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle), or (2) observation. If CR or CRi, but not CRm, patients received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
403597|NCT00492856|P4|Participant Flow|Post-consolidation Gemtuzumab Ozogamicin|Patients who did not achieve CRm, but achieved CR/CRi and are PML-RARα-positive after consolidation received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does).
403598|NCT00492856|P3|Participant Flow|Post-consolidation Observation|Patients who achieved CRm after consolidation and were randomized to the observation arm.
403599|NCT00492856|P2|Participant Flow|Post-consolidation ATRA, 6-MP, MTX|Patients who achieved CRm after consolidation and were randomized or assigned to the treatment arm received ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
403600|NCT00492856|P1|Participant Flow|Low and Intermediate Risk APL Patients|All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
403601|NCT00492856|O2|Outcome|Post-consolidation Therapy Arm II|Patients receive no further chemotherapy. (Randomization and observation arm closed as of 05/27/10)
403602|NCT00492856|O1|Outcome|Post-consolidation Therapy Arm I|"Patients receive oral tretinoin twice daily on days 1-7, oral mercaptopurine once daily on days 1-14, and oral methotrexate on day 1. Treatment repeats every 2 weeks for up to 1 year.
mercaptopurine: Given orally
methotrexate: Given orally
tretinoin: Given orally"
403603|NCT00492856|O4|Outcome|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
403604|NCT00492856|O3|Outcome|ATRA+6-MP+MTX|ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle).
403605|NCT00492856|O2|Outcome|Consolidation|Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
403606|NCT00492856|O1|Outcome|ATRA + Ara-C + Daunorubicin|ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6
403607|NCT00492856|E4|Reported Event|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
403608|NCT00492856|E3|Reported Event|ATRA+6-MP+MTX|ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle).
403609|NCT00492856|E2|Reported Event|Consolidation|Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
403610|NCT00492856|E1|Reported Event|ATRA + Ara-C + Daunorubicin|ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6
403611|NCT00492973|B3|Baseline|Total|Total of all reporting groups
403612|NCT00492973|B2|Baseline|Corticosteroid|"Corticosteroid (methylprednisolone acetate)
methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
403613|NCT00492973|B1|Baseline|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.
active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
403614|NCT00492973|P2|Participant Flow|Corticosteroid|"Corticosteroid (methylprednisolone acetate)
methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
403616|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)
methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
403617|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.
active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
403618|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)
methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
403619|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.
active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
403620|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)
methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
403621|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.
active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
403622|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)
methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
403623|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.
active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
403624|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)
methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
403625|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.
active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
403626|NCT00492973|E2|Reported Event|Corticosteroid|"Corticosteroid (methylprednisolone acetate)
methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
403627|NCT00492973|E1|Reported Event|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.
active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
403628|NCT00493012|B3|Baseline|Total|Total of all reporting groups
403629|NCT00493012|B2|Baseline|Placebo Comparator|A daily placebo oil is given for year
403630|NCT00493012|B1|Baseline|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403631|NCT00493012|P2|Participant Flow|Placebo Comparator|A daily placebo oil is given for year
403632|NCT00493012|P1|Participant Flow|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403633|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
403634|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403635|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
403636|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403637|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
403638|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403639|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
403640|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403641|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
403642|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403643|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
403644|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403645|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
403646|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403647|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
403648|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403649|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
403650|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403651|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
403652|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403653|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
425882|NCT00542425|P5|Participant Flow|Teriparatide|
403656|NCT00493012|E1|Reported Event|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
403657|NCT00493038|B3|Baseline|Total|Total of all reporting groups
403928|NCT00486863|B1|Baseline|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403658|NCT00493038|B2|Baseline|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
403659|NCT00493038|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
403660|NCT00493038|P2|Participant Flow|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
403661|NCT00493038|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
403662|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
403663|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
403664|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
403665|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
403666|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
403667|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
403668|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
403669|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
403670|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
403671|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
403672|NCT00493038|E2|Reported Event|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
403673|NCT00493038|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
403674|NCT00481065|B9|Baseline|Total|Total of all reporting groups
403675|NCT00481065|B8|Baseline|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403676|NCT00481065|B7|Baseline|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403677|NCT00481065|B6|Baseline|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403678|NCT00481065|B5|Baseline|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403679|NCT00481065|B4|Baseline|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403680|NCT00481065|B3|Baseline|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403681|NCT00481065|B2|Baseline|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403682|NCT00481065|B1|Baseline|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403683|NCT00481065|P8|Participant Flow|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403684|NCT00481065|P7|Participant Flow|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403685|NCT00481065|P6|Participant Flow|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403686|NCT00481065|P5|Participant Flow|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403687|NCT00481065|P4|Participant Flow|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403688|NCT00481065|P3|Participant Flow|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403689|NCT00481065|P2|Participant Flow|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403725|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403690|NCT00481065|P1|Participant Flow|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403691|NCT00481065|O2|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403692|NCT00481065|O1|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403693|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403694|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403695|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403696|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403697|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403698|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403699|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403700|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403701|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403702|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403703|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403704|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403705|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403706|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403707|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403708|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403709|NCT00481065|O2|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403710|NCT00481065|O1|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403711|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403712|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403713|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403714|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403715|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403716|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403717|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403718|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403719|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403720|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403721|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403722|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403723|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403724|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403726|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403727|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403728|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403729|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403730|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403731|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403732|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403733|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403734|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403735|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403736|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403737|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403738|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403739|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403740|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403741|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403742|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403743|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403744|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403745|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403746|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403747|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403748|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403749|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403750|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403751|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403752|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403753|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403754|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403755|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403756|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403757|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
425883|NCT00542425|P4|Participant Flow|BA058 80 µg|
403758|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403760|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403761|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403762|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403763|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403764|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403765|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403766|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403767|NCT00481065|E8|Reported Event|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403768|NCT00481065|E7|Reported Event|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403769|NCT00481065|E6|Reported Event|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403770|NCT00481065|E5|Reported Event|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
403771|NCT00481065|E4|Reported Event|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403772|NCT00481065|E3|Reported Event|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403773|NCT00481065|E2|Reported Event|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403774|NCT00481065|E1|Reported Event|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
403775|NCT00481078|B3|Baseline|Total|Total of all reporting groups
403776|NCT00481078|B2|Baseline|Arm 2|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
403777|NCT00481078|B1|Baseline|Arm 1|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
403778|NCT00481078|P2|Participant Flow|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
403779|NCT00481078|P1|Participant Flow|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
403780|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
403781|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
403782|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
403783|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
403784|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
403785|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
403786|NCT00481078|E2|Reported Event|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
403787|NCT00481078|E1|Reported Event|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
403788|NCT00486447|B1|Baseline|Imaging|"General imaging subjects receiving CT exams
64 Channel VCT: cardiac CT angiography exam"
403789|NCT00486447|P1|Participant Flow|Imaging|Enrolled subjects for general imaging
403790|NCT00486447|O1|Outcome|Outcome Measure 2|1 year clinical outcome follow-up (Study terminated prior to collection)
403791|NCT00486447|O1|Outcome|Enrolled|Enrolled subjects for general imaging
403792|NCT00486447|E1|Reported Event|Enrolled|Subjects receiving diagnostic CT scans
403793|NCT00486525|B3|Baseline|Total|Total of all reporting groups
403794|NCT00486525|B2|Baseline|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
403795|NCT00486525|B1|Baseline|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
403796|NCT00486525|P2|Participant Flow|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
403797|NCT00486525|P1|Participant Flow|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
403798|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
403799|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
403800|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
403801|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
403802|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
403803|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
403804|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
403805|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
403806|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
403807|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
403808|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
403809|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
403810|NCT00486525|E2|Reported Event|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
403811|NCT00486525|E1|Reported Event|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
403812|NCT00486642|B3|Baseline|Total|Total of all reporting groups
403813|NCT00486642|B2|Baseline|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403814|NCT00486642|B1|Baseline|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403815|NCT00486642|P2|Participant Flow|Arm II (Pazopanib & Bicalutamide)|Arm II - Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
403816|NCT00486642|P1|Participant Flow|Arm I (Pazopanib)|"Arm I - Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403817|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403818|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403819|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403820|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
404994|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
403821|NCT00486642|O2|Outcome|Arm B (Pazopanib + Bicalutamide)|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
456451|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
403822|NCT00486642|O1|Outcome|Arm A (Pazopanib)|"Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403823|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403824|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403825|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403826|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403827|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403828|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403829|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403830|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403831|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403832|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403833|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403834|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403835|NCT00486642|E2|Reported Event|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403836|NCT00486642|E1|Reported Event|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies"
403837|NCT00486720|B3|Baseline|Total|Total of all reporting groups
403838|NCT00486720|B2|Baseline|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
403839|NCT00486720|B1|Baseline|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
403840|NCT00486720|P2|Participant Flow|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
403841|NCT00486720|P1|Participant Flow|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
403842|NCT00486720|O2|Outcome|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
403843|NCT00486720|O1|Outcome|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
403844|NCT00486720|O2|Outcome|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
403845|NCT00486720|O1|Outcome|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
403846|NCT00486720|E2|Reported Event|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
403847|NCT00486720|E1|Reported Event|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
403848|NCT00486759|B3|Baseline|Total|Total of all reporting groups
403849|NCT00486759|B2|Baseline|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
403850|NCT00486759|B1|Baseline|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
403922|NCT00486837|O2|Outcome|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
425884|NCT00542425|P3|Participant Flow|BA058 40 µg|
403851|NCT00486759|P2|Participant Flow|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
456452|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
403852|NCT00486759|P1|Participant Flow|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
403853|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
403854|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
403855|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
403856|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
403857|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
403858|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
403859|NCT00486759|E2|Reported Event|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
403860|NCT00486759|E1|Reported Event|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
403861|NCT00486811|B4|Baseline|Total|Total of all reporting groups
403862|NCT00486811|B3|Baseline|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403863|NCT00486811|B2|Baseline|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403864|NCT00486811|B1|Baseline|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403865|NCT00486811|P3|Participant Flow|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403866|NCT00486811|P2|Participant Flow|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily) The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403867|NCT00486811|P1|Participant Flow|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403868|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403869|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403923|NCT00486837|O1|Outcome|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
403927|NCT00486863|B2|Baseline|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
405205|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
403870|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403871|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403872|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403873|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403874|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403875|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403876|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403877|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403878|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403879|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403880|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403881|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403882|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403883|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403924|NCT00486837|E2|Reported Event|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
405595|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
403884|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403885|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403886|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403887|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403888|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403889|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403890|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403891|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403892|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403893|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403894|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403895|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403896|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403897|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403925|NCT00486837|E1|Reported Event|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
403926|NCT00486863|B3|Baseline|Total|Total of all reporting groups
403898|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403899|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403900|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403901|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403902|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403903|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403904|NCT00486811|E3|Reported Event|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
403905|NCT00486811|E2|Reported Event|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
403906|NCT00486811|E1|Reported Event|Placebo Matching|"Drug: Matching Placebo (twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
403907|NCT00486837|B3|Baseline|Total|Total of all reporting groups
403908|NCT00486837|B2|Baseline|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
403909|NCT00486837|B1|Baseline|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
403910|NCT00486837|P2|Participant Flow|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
403911|NCT00486837|P1|Participant Flow|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
403912|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition
Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
403913|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition
Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
403914|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition
Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
403915|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition
Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
403916|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition
Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
403917|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition
Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
403918|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition
Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
403919|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition
Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
403920|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition
Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
403921|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition
Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
403929|NCT00486863|P2|Participant Flow|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours. The agent was gel encapsulated to reduce appreciation of odor and taste and mimic appearance of the placebo.
403930|NCT00486863|P1|Participant Flow|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules as the test agent, but with the inert compound dextrose.
403931|NCT00486863|O1|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403932|NCT00486863|O1|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403933|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403934|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403935|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403936|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403937|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403938|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403939|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403940|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403941|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403942|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403943|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403944|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403945|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403946|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403947|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403948|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403949|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403950|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403951|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403952|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403953|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403954|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403955|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403956|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403957|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403958|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403959|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403960|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403961|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403962|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403963|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403964|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403965|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403966|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403967|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403968|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403969|NCT00486863|E2|Reported Event|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
403970|NCT00486863|E1|Reported Event|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
403971|NCT00486902|B3|Baseline|Total|Total of all reporting groups
403972|NCT00486902|B2|Baseline|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
403973|NCT00486902|B1|Baseline|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
403974|NCT00486902|P2|Participant Flow|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
403975|NCT00486902|P1|Participant Flow|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
403976|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
403977|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
403978|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
403979|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
403980|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
403981|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
403982|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
403983|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
403984|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
403985|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
403986|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
403987|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
403988|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
403989|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
403990|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
403991|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
403992|NCT00486902|E2|Reported Event|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
403993|NCT00486902|E1|Reported Event|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
403994|NCT00486954|B5|Baseline|Total|Total of all reporting groups
403995|NCT00486954|B4|Baseline|Paclitaxel Alone in Randomized Part|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
403996|NCT00486954|B3|Baseline|Lapatinib Plus Paclitaxel in Randomized Part|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
403997|NCT00486954|B2|Baseline|Lapatinib Plus Paclitaxel in Gastrectomy Participants|In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
403998|NCT00486954|B1|Baseline|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
403999|NCT00486954|P5|Participant Flow|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404000|NCT00486954|P4|Participant Flow|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404001|NCT00486954|P3|Participant Flow|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404002|NCT00486954|P2|Participant Flow|Lapatinib Plus Paclitaxel in Partial Gastrectomy Participants|Participants with partial gastrectomy (which includes preservation of the pylorus) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2. Partial gastrectomy (pylorus preserved) is very rare population in Japan. As a result, no such participants were recruited into this cohort.
404003|NCT00486954|P1|Participant Flow|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404004|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404005|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404006|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404278|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404007|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404008|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404009|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404010|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404011|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404012|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404013|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404014|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404015|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404016|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404017|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404018|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404019|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404020|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404021|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404022|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404023|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404024|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404025|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404026|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404027|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404028|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404029|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404030|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404031|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404032|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404033|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404034|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
425885|NCT00542425|P2|Participant Flow|BA058 20 µg|
404384|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404035|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404036|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404037|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404038|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404039|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404040|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404041|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404042|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404043|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404044|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404045|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404046|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404047|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404048|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404049|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404050|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404051|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404052|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404053|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404054|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404055|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404056|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404057|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404058|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404059|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404060|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404061|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404062|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404108|NCT00493220|B1|Baseline|HYLENEX SC, Placebo SC, IV|subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
404063|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404064|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404065|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404066|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404067|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404068|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404069|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404070|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404071|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404072|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404073|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404074|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404075|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404076|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404077|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404078|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404079|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404080|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404081|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404082|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404109|NCT00493220|P6|Participant Flow|IV, Placebo SC, HYLENEX SC|intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
404995|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
404083|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404084|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404085|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404086|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404087|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404088|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404089|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404090|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404091|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404092|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404093|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404094|NCT00486954|E4|Reported Event|Paclitaxel Alone in Randomized Part|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404095|NCT00486954|E3|Reported Event|Lapatinib Plus Paclitaxel in Randomized Part|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
404096|NCT00486954|E2|Reported Event|Lapatinib Plus Paclitaxel in Gastrectomy Participants|In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
404097|NCT00486954|E1|Reported Event|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
404098|NCT00493181|B1|Baseline|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
404099|NCT00493181|P1|Participant Flow|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
404100|NCT00493181|O1|Outcome|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
404101|NCT00493181|E1|Reported Event|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
404102|NCT00493220|B7|Baseline|Total|Total of all reporting groups
404103|NCT00493220|B6|Baseline|IV, Placebo SC, HYLENEX SC|intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
404104|NCT00493220|B5|Baseline|IV, HYLENEX SC, Placebo SC|intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
404105|NCT00493220|B4|Baseline|Placebo SC, IV, HYLENEX SC|subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
404106|NCT00493220|B3|Baseline|Placebo SC, HYLENEX SC, IV|subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
404107|NCT00493220|B2|Baseline|HYLENEX SC, IV, Placebo SC|subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
404996|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
404110|NCT00493220|P5|Participant Flow|IV, HYLENEX SC, Placebo SC|intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
404111|NCT00493220|P4|Participant Flow|Placebo SC, IV, HYLENEX SC|subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
404112|NCT00493220|P3|Participant Flow|Placebo SC, HYLENEX SC, IV|subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
404113|NCT00493220|P2|Participant Flow|HYLENEX SC, IV, Placebo SC|subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
404114|NCT00493220|P1|Participant Flow|HYLENEX SC, Placebo SC, IV|subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
404115|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
404116|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
404117|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
404118|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
404119|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
404120|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
404121|NCT00493220|O3|Outcome|Intravenous|All per-protocol participant administered intravenous ceftriaxone
404122|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
404123|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
404124|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
404125|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
404126|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous hylenex and ceftriaxone
404127|NCT00493220|E3|Reported Event|Intravenous|All participants administered intravenous ceftriaxone
404128|NCT00493220|E2|Reported Event|Placebo SC|All participants administered subcutaneous placebo and ceftriaxone
404129|NCT00493220|E1|Reported Event|HYLENEX SC|All participants administered subcutaneous HYLENEX and ceftriaxone
404130|NCT00493246|B9|Baseline|Total|Total of all reporting groups
404131|NCT00493246|B8|Baseline|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404132|NCT00493246|B7|Baseline|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404133|NCT00493246|B6|Baseline|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404134|NCT00493246|B5|Baseline|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404135|NCT00493246|B4|Baseline|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404136|NCT00493246|B3|Baseline|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404137|NCT00493246|B2|Baseline|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
404138|NCT00493246|B1|Baseline|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
404139|NCT00493246|P8|Participant Flow|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404140|NCT00493246|P7|Participant Flow|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404141|NCT00493246|P6|Participant Flow|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404142|NCT00493246|P5|Participant Flow|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404143|NCT00493246|P4|Participant Flow|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404144|NCT00493246|P3|Participant Flow|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404145|NCT00493246|P2|Participant Flow|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
404146|NCT00493246|P1|Participant Flow|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
404147|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404148|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404149|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404150|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404151|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404152|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404153|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
404154|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
404155|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404156|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404157|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404158|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404159|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404160|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404161|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
404162|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
404163|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404164|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404165|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404166|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404167|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404168|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404169|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
404170|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
404171|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404172|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
405596|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
404173|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404174|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404175|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404176|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404177|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
404178|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
404179|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404180|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404181|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404182|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404183|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404184|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404185|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
404186|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
404187|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404188|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404189|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404190|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404191|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404192|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404193|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
404194|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
404195|NCT00493246|E8|Reported Event|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404196|NCT00493246|E7|Reported Event|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404197|NCT00493246|E6|Reported Event|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404198|NCT00493246|E5|Reported Event|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404199|NCT00493246|E4|Reported Event|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
425886|NCT00542425|P1|Participant Flow|Placebo|
404200|NCT00493246|E3|Reported Event|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
404201|NCT00493246|E2|Reported Event|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
404202|NCT00493246|E1|Reported Event|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
404203|NCT00493285|B7|Baseline|TOTAL|Total of all reporting groups
404204|NCT00493285|B6|Baseline|10^6 PLACEBO|
404205|NCT00493285|B5|Baseline|10^6 MEDI-534|
404206|NCT00493285|B4|Baseline|10^5 PLACEBO|
404207|NCT00493285|B3|Baseline|10^5 MEDI-534|
404208|NCT00493285|B2|Baseline|10^4 PLACEBO|
404209|NCT00493285|B1|Baseline|10^4 MEDI-534|
404210|NCT00493285|P6|Participant Flow|10^6 PLACEBO|
404211|NCT00493285|P5|Participant Flow|10^6 MEDI-534|
404212|NCT00493285|P4|Participant Flow|10^5 PLACEBO|
404213|NCT00493285|P3|Participant Flow|10^5 MEDI-534|
404214|NCT00493285|P2|Participant Flow|10^4 PLACEBO|
404215|NCT00493285|P1|Participant Flow|10^4 MEDI-534|
404216|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404217|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404218|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404219|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404220|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404221|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404222|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404223|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404224|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404225|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404226|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404227|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404228|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404229|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404230|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404231|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404232|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404233|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404234|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404235|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404236|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404237|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404238|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404239|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404240|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404241|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404242|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404997|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
404243|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404244|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404245|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404246|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404247|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404248|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404249|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404250|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404251|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404252|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404253|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404254|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404255|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404256|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404257|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404258|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404259|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404260|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404261|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404262|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404263|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404264|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404265|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404266|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404267|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404268|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404269|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404270|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404271|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404272|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404273|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404274|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404275|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404276|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404277|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404998|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
404279|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404280|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404281|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404282|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404283|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404284|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404285|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404286|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404287|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404288|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404289|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404290|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404291|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404292|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404293|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404294|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404295|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404296|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404297|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404298|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404299|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404300|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404301|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404302|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404303|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404304|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404305|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404306|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404307|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404308|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404309|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404310|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404311|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404312|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404348|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404463|NCT00494676|O1|Outcome|Entire Study Population Who Continued|Includes groups allocated to receive real prism glasses first and sham prism glasses first
404313|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404314|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404315|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404316|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404317|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404318|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404319|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404320|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404321|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404322|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404323|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404324|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404325|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404326|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404327|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404328|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404329|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404330|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404331|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404332|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404333|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404334|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404335|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404336|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404337|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404338|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404339|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404340|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404341|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404342|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404343|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404344|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404345|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404346|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404347|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
405597|NCT00500318|E2|Reported Event|Placebo|Dose-matched placebo, oral inhalation, once per day.
404349|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404350|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404351|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404352|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404353|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404354|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404355|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404356|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404357|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404358|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404359|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404360|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404361|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404362|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404363|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404364|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404365|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404366|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404367|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404368|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404369|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404370|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404371|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404372|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404373|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404374|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404375|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404376|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404377|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404378|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404379|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404380|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404381|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404382|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404383|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
406272|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
404385|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404386|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404387|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404388|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404389|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404390|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404391|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404392|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404393|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404394|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404395|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404396|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404397|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404398|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404399|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404400|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404401|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404402|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404403|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404404|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404405|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404406|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404407|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404408|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404409|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404410|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404411|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404412|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404413|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404414|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404415|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404416|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404417|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404418|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404462|NCT00494676|O1|Outcome|Entire Study Population Who Discontinued|Includes groups allocated to receive real prism glasses first and sham prism glasses first
404464|NCT00494676|O1|Outcome|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
404419|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404420|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404421|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404422|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404423|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404424|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404425|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404426|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404427|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404428|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404429|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404430|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
404431|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
404432|NCT00493285|E6|Reported Event|10^6 PLACEBO|
404433|NCT00493285|E5|Reported Event|10^6 MEDI-534|
404434|NCT00493285|E4|Reported Event|10^5 PLACEBO|
404435|NCT00493285|E3|Reported Event|10^5 MEDI-534|
404436|NCT00493285|E2|Reported Event|10^4 PLACEBO|
404437|NCT00493285|E1|Reported Event|10^4 MEDI-534|
404438|NCT00493311|B3|Baseline|Total|Total of all reporting groups
404439|NCT00493311|B2|Baseline|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
404440|NCT00493311|B1|Baseline|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
404441|NCT00493311|P2|Participant Flow|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
404442|NCT00493311|P1|Participant Flow|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
404443|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
404444|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
404445|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
404446|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
404447|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
404448|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
404449|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
404450|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
404451|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
404452|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
404453|NCT00493311|E2|Reported Event|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
404454|NCT00493311|E1|Reported Event|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
404455|NCT00494585|B1|Baseline|CEP-701|80 mg orally twice daily for 30 days
404456|NCT00494585|P1|Participant Flow|CEP-701|80 mg orally twice daily for 30 days
404457|NCT00494585|O1|Outcome|CEP-701|80 mg orally twice daily for 30 days
404458|NCT00494585|E1|Reported Event|CEP-701|80 mg orally twice daily for 30 days
404459|NCT00494676|B1|Baseline|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
404460|NCT00494676|P2|Participant Flow|Sham Prism Glasses Then Real|Sham prism glasses for 4 weeks followed by real prism glasses for 4 weeks
404461|NCT00494676|P1|Participant Flow|Real Prism Glasses Then Sham|Real prism glasses for 4 weeks followed by sham prism glasses for 4 weeks
404465|NCT00494676|O1|Outcome|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
404466|NCT00494676|E1|Reported Event|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
404467|NCT00494780|B3|Baseline|Total|Total of all reporting groups
404468|NCT00494780|B2|Baseline|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404469|NCT00494780|B1|Baseline|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404470|NCT00494780|P2|Participant Flow|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404471|NCT00494780|P1|Participant Flow|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) on Day 3 of each 21-day cycle, with 300 milligrams (mg) in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404472|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404473|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404474|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404475|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404476|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404477|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404478|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404479|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404480|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404481|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404482|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404483|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404484|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404535|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404485|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404486|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404487|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404488|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404489|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404490|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404491|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404492|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404493|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404494|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404495|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404496|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404497|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404498|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404499|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404500|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404501|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404502|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404503|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404536|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404703|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404537|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404538|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404504|NCT00494780|E4|Reported Event|1000 mg Ofatumumab + CHOP: Extended Follow-up|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404505|NCT00494780|E3|Reported Event|500 mg Ofatumumab + CHOP: Extended Follow-up|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404506|NCT00494780|E2|Reported Event|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404507|NCT00494780|E1|Reported Event|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
404508|NCT00494806|B3|Baseline|Total|Total of all reporting groups
404509|NCT00494806|B2|Baseline|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
404510|NCT00494806|B1|Baseline|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
404511|NCT00494806|P2|Participant Flow|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
404512|NCT00494806|P1|Participant Flow|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
404513|NCT00494806|O2|Outcome|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
404514|NCT00494806|O1|Outcome|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
404515|NCT00494806|E2|Reported Event|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
404516|NCT00494806|E1|Reported Event|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
404517|NCT00494871|B3|Baseline|Total|Total of all reporting groups
404518|NCT00494871|B2|Baseline|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404519|NCT00494871|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404520|NCT00494871|P2|Participant Flow|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404521|NCT00494871|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404522|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404523|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404524|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404525|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404526|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404527|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404528|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404529|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404530|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404531|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404532|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404533|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404534|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404634|NCT00495586|P2|Participant Flow|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
404539|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404540|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404541|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404542|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404543|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404544|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
404545|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
404546|NCT00494871|E4|Reported Event|RG4: Warfarin FU Period|Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
404547|NCT00494871|E3|Reported Event|RG3: Rivaroxaban Follow-up (FU) Period|Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
404548|NCT00494871|E2|Reported Event|RG2: Warfarin DB Period|Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
404549|NCT00494871|E1|Reported Event|RG1: Rivaroxaban Double-blind (DB) Period|Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
404550|NCT00494975|B3|Baseline|Total|Total of all reporting groups
404551|NCT00494975|B2|Baseline|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
404552|NCT00494975|B1|Baseline|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
404553|NCT00494975|P2|Participant Flow|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
404554|NCT00494975|P1|Participant Flow|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
404555|NCT00494975|O2|Outcome|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
404556|NCT00494975|O1|Outcome|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
404557|NCT00494975|E2|Reported Event|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
404558|NCT00494975|E1|Reported Event|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
404559|NCT00495079|B1|Baseline|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
404560|NCT00495079|P1|Participant Flow|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
404561|NCT00495079|O1|Outcome|Marqibo|"Proportion if subjects who achieved CR+CRi as determined by the IRRC using the International Working Group (IWG)Criteria. The IRRC Evaluable analysis set(n=53) included subjects who received at least 1 dose of study drug and reviewable data.
Eligible subjects received Marqibo at 2.25mg^m2 intravenously via peripheral or central venous access over 60 minutes (+/-10 minutes) every 7 days (+/-3days)"
404562|NCT00495079|O1|Outcome|Marqibo|"The population analyzed included all subjects who received at least one dose of Marqibo. Subjects who did not die had their survival times censored on the date of last contact. The K-M method was used to estimate the distribution of overall survival.
Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes)every 7 days (+/- 3 days)"
404563|NCT00495079|O1|Outcome|Marqibo|"Duration of response derived using the IRRC determined response dates for subjects who achieved CR or CRi (n=8). The K-M product limit method was used to estimate the median event time.
Eligible subjects received Marqibo at 2.25mg^m2 intravenously via peripheral or central venous access over 60 minutes (+- 10 minutes)every 7 days (+/- 3 days)"
404564|NCT00495079|O1|Outcome|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
404565|NCT00495079|E1|Reported Event|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
404566|NCT00495131|B3|Baseline|Total|Total of all reporting groups
404567|NCT00495131|B2|Baseline|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
404705|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404568|NCT00495131|B1|Baseline|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
404569|NCT00495131|P2|Participant Flow|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
404570|NCT00495131|P1|Participant Flow|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
404571|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
404572|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
404573|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
404574|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
404575|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
404576|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
404577|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
404578|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
404579|NCT00495157|B4|Baseline|Total|Total of all reporting groups
404580|NCT00495157|B3|Baseline|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404581|NCT00495157|B2|Baseline|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404582|NCT00495157|B1|Baseline|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404583|NCT00495157|P3|Participant Flow|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404584|NCT00495157|P2|Participant Flow|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404585|NCT00495157|P1|Participant Flow|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404586|NCT00495157|O3|Outcome|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404587|NCT00495157|O2|Outcome|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404588|NCT00495157|O1|Outcome|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404589|NCT00495157|E3|Reported Event|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404590|NCT00495157|E2|Reported Event|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404591|NCT00495157|E1|Reported Event|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
404592|NCT00495222|B1|Baseline|Tissue Plication|
404593|NCT00495222|P1|Participant Flow|Tissue Plication|
404594|NCT00495222|O1|Outcome|Tissue Plication|
404595|NCT00495391|B3|Baseline|Total|Total of all reporting groups
404596|NCT00495391|B2|Baseline|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks."
404597|NCT00495391|B1|Baseline|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
404636|NCT00495586|O2|Outcome|Placebo|Ninety exacerbations were reported during the year of follow up among those patients who had clinical success at end of therapy visit (90/123: 73.2%)
405206|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
404598|NCT00495391|P2|Participant Flow|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks."
404599|NCT00495391|P1|Participant Flow|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
404600|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks."
404601|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
404602|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks."
404603|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
404604|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks."
404605|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
404606|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks."
404607|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
404608|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks."
404609|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
404610|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks."
404635|NCT00495586|P1|Participant Flow|Placebo|Placebo pills t.i.d. for 8 days
404611|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
404612|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks."
404613|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
404614|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks."
404615|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
404616|NCT00495391|E2|Reported Event|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks."
404617|NCT00495391|E1|Reported Event|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
404618|NCT00495495|B1|Baseline|Ozone Treatment/Placebo Treatment|Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds.
404619|NCT00495495|P1|Participant Flow|Ozone Treatment and Placebo Treatment|60-second Ozone device treatment compared to 60-second Placebo device treatment. Study utilized split-mouth design. The paired treatment assignment for the two teeth within each subject was performed according to a randomization table provided by the Biometrician. Randomization of teeth to Ozone treatment or Placebo treatment was stratifed according to tooth similarity.
404620|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
404621|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
404622|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
404623|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
404624|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
404625|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
404626|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
404627|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
404628|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
404629|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
404630|NCT00495495|E1|Reported Event|Ozone Treatment and Placebo Treatment|Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randominzed to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds.
404631|NCT00495586|B3|Baseline|Total|Total of all reporting groups
404632|NCT00495586|B2|Baseline|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
404633|NCT00495586|B1|Baseline|Placebo|Placebo pills t.i.d. for 8 days
404637|NCT00495586|O1|Outcome|Amoxicillin and Clavulanic Acid|Eighty-three exacerbations were reported during the year of follow up among those patients who had clinical success at end of therapy visit (83/143: 58%)
404638|NCT00495586|O2|Outcome|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
404639|NCT00495586|O1|Outcome|Placebo|Placebo pills t.i.d. for 8 days
404640|NCT00495586|E2|Reported Event|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
404641|NCT00495586|E1|Reported Event|Placebo|Placebo pills t.i.d. for 8 days
404642|NCT00495612|B3|Baseline|Total|Total of all reporting groups
404643|NCT00495612|B2|Baseline|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
404644|NCT00495612|B1|Baseline|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
404645|NCT00495612|P2|Participant Flow|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
404646|NCT00495612|P1|Participant Flow|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
404647|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
404648|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
404649|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
404650|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
404651|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
404652|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
404653|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
404654|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
404655|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
404656|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
404657|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
404658|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
404659|NCT00495612|E2|Reported Event|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
404660|NCT00495612|E1|Reported Event|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
404661|NCT00495625|B1|Baseline|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
404662|NCT00495625|P1|Participant Flow|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
404663|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
404664|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
404702|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404704|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404665|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
404666|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
404667|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
404668|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
404669|NCT00495625|E1|Reported Event|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
404670|NCT00495677|B8|Baseline|Total|Total of all reporting groups
404671|NCT00495677|B7|Baseline|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404672|NCT00495677|B6|Baseline|PF-00232798 400mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404673|NCT00495677|B5|Baseline|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404674|NCT00495677|B4|Baseline|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404675|NCT00495677|B3|Baseline|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404676|NCT00495677|B2|Baseline|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404677|NCT00495677|B1|Baseline|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404678|NCT00495677|P7|Participant Flow|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404679|NCT00495677|P6|Participant Flow|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404680|NCT00495677|P5|Participant Flow|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404681|NCT00495677|P4|Participant Flow|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404682|NCT00495677|P3|Participant Flow|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404683|NCT00495677|P2|Participant Flow|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404684|NCT00495677|P1|Participant Flow|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404685|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404686|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404687|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404688|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404689|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404690|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404691|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404692|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404693|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404694|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404695|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404696|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404697|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404698|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404699|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404700|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404701|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404746|NCT00495794|P2|Participant Flow|Usual Care|Eligible patients receive usual care
404706|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404707|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404708|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404709|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404710|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404711|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404712|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404713|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404714|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404715|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404716|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404717|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404718|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404719|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404720|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404721|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404722|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404723|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404724|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404725|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404726|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404727|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404728|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404729|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404730|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404731|NCT00495677|E7|Reported Event|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404732|NCT00495677|E6|Reported Event|PF-00232798 400mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404733|NCT00495677|E5|Reported Event|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404734|NCT00495677|E4|Reported Event|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404735|NCT00495677|E3|Reported Event|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
404736|NCT00495677|E2|Reported Event|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404737|NCT00495677|E1|Reported Event|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
404738|NCT00495755|B1|Baseline|Campath (Alemtuzumab)|
404739|NCT00495755|P1|Participant Flow|Campath (Alemtuzumab)|3 dose cohorts entered
404740|NCT00495755|O1|Outcome|Response|
404741|NCT00495755|O1|Outcome|Maximum Tolerated Dose (MTD)|
404742|NCT00495755|E1|Reported Event|Campath (Alemtuzumab)|
404743|NCT00495794|B3|Baseline|Total|Total of all reporting groups
404744|NCT00495794|B2|Baseline|Usual Care|Eligible patients receive usual care
404745|NCT00495794|B1|Baseline|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)
Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
406273|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
404784|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404785|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404747|NCT00495794|P1|Participant Flow|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)
Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
404748|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
404749|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)
Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
404750|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
404751|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)
Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
404752|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
404753|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)
Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
404754|NCT00495794|E2|Reported Event|Usual Care|Eligible patients receive usual care
404755|NCT00495794|E1|Reported Event|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)
Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
404756|NCT00495820|B3|Baseline|Total|Total of all reporting groups
404757|NCT00495820|B2|Baseline|Arm 2|"Placebo
Placebo: Standard inactive pill."
404758|NCT00495820|B1|Baseline|Arm 1|"Methylphenidate
Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study."
404759|NCT00495820|P2|Participant Flow|Arm 2|"Placebo
Placebo: Standard inactive pill."
404760|NCT00495820|P1|Participant Flow|Arm 1|"Methylphenidate
Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study."
404761|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
404762|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
404763|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
404764|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
404765|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
404766|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
404767|NCT00495820|E2|Reported Event|Placebo Group|Subjects randomized to this group received methylphenidate
404768|NCT00495820|E1|Reported Event|Methylphenidate Group|Subjects randomized to this group received methylphenidate
404769|NCT00496054|B1|Baseline|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404770|NCT00496054|P1|Participant Flow|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404771|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404772|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404773|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404774|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404775|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404776|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404777|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404778|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404779|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404780|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404781|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404782|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404783|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
406274|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
404786|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404787|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404788|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404789|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404790|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404791|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404792|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404793|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404794|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404795|NCT00496054|E1|Reported Event|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
404796|NCT00496080|B1|Baseline|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
404797|NCT00496080|P1|Participant Flow|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
404798|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
404799|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
404800|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
404801|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
404802|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
404803|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
404804|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
404805|NCT00496080|E1|Reported Event|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
404806|NCT00496197|B1|Baseline|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404807|NCT00496197|P1|Participant Flow|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404808|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404809|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404810|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404811|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404874|NCT00496470|B1|Baseline|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404875|NCT00496470|P2|Participant Flow|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404999|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
404879|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404880|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404812|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404813|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404814|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404815|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404816|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404817|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404818|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404819|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404820|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404821|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404822|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404823|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404876|NCT00496470|P1|Participant Flow|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404877|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404824|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404825|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404826|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404827|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404828|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404829|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404830|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404831|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404832|NCT00496197|E1|Reported Event|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
404833|NCT00496262|B1|Baseline|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
404834|NCT00496262|P1|Participant Flow|Human Fibrinogen Concentrate|All enrolled subjects received a single IV infusion of 70 mg/kg body weight of human fibrinogen concentrate.
404835|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
404836|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
404837|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
404838|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
404839|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
404840|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
404841|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
404842|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
404843|NCT00496262|O2|Outcome|1 Hour Post-infusion|1 hour after end of infusion
404844|NCT00496262|O1|Outcome|Pre-infusion|≤ 2 hours before start of infusion
404845|NCT00496262|E1|Reported Event|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
405000|NCT00496730|E2|Reported Event|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
404846|NCT00496340|B1|Baseline|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404847|NCT00496340|P1|Participant Flow|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total area under curve (AUC) of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404848|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404849|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404850|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404851|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404852|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404853|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404854|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404878|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404855|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404856|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404857|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404858|NCT00496340|E1|Reported Event|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
404859|NCT00496366|B1|Baseline|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
404860|NCT00496366|P1|Participant Flow|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
404861|NCT00496366|O1|Outcome|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
404862|NCT00496366|O1|Outcome|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
404863|NCT00496366|E1|Reported Event|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Lapatinib will be taken daily continuously for 21 days (Days 1- 21).
Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
404864|NCT00496379|B1|Baseline|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
404865|NCT00496379|P1|Participant Flow|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
404866|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
404867|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
404868|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
404869|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
404870|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
404871|NCT00496379|E1|Reported Event|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
404872|NCT00496470|B3|Baseline|Total|Total of all reporting groups
404873|NCT00496470|B2|Baseline|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404992|NCT00496730|P2|Participant Flow|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
404881|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404882|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404883|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404884|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404885|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404886|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404887|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404888|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404889|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404890|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404891|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404892|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404893|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404894|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404895|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404896|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404897|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404898|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404899|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404900|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404901|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404902|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404903|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404904|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404905|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404906|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404907|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404908|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404909|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404910|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404911|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404912|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404913|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404914|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404915|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404916|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404917|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404918|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404919|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404920|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404921|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404922|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404923|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404924|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404925|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404926|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404927|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404928|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404929|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404930|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404931|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404932|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404933|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404934|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404935|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404936|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404937|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404938|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404939|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404940|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404941|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404942|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404943|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404944|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404945|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404946|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404947|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404948|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404949|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404950|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404951|NCT00496470|E2|Reported Event|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
404952|NCT00496470|E1|Reported Event|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
404953|NCT00496483|B1|Baseline|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
404954|NCT00496483|P1|Participant Flow|LCP-Tacro|"All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15.
On Day 22 patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days.
LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL."
404955|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
404993|NCT00496730|P1|Participant Flow|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
404956|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
405107|NCT00496873|B1|Baseline|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
404957|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
404958|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
404959|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
404960|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
404961|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
404962|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
404963|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
404964|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
404965|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
404966|NCT00496483|E2|Reported Event|Prograf|"Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
60 patients were entrolled into the study and one withdrew consent right after screening. Therefore 59 patients are inlcuded in the ITT safety set."
404967|NCT00496483|E1|Reported Event|LCP-Tacro|"LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
60 patients were enrolled into the study, but only 51 were dosed with LCP-Tacro."
404968|NCT00496587|B1|Baseline|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
404969|NCT00496587|P1|Participant Flow|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
404970|NCT00496587|O1|Outcome|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
404971|NCT00496587|O1|Outcome|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
404972|NCT00496587|O1|Outcome|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
404973|NCT00496587|E1|Reported Event|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
404974|NCT00496626|B3|Baseline|Total|Total of all reporting groups
404975|NCT00496626|B2|Baseline|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404976|NCT00496626|B1|Baseline|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404977|NCT00496626|P2|Participant Flow|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404978|NCT00496626|P1|Participant Flow|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404979|NCT00496626|O2|Outcome|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404980|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404981|NCT00496626|O2|Outcome|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404982|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404983|NCT00496626|O4|Outcome|Placebo Group (Month 7)|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404984|NCT00496626|O3|Outcome|Vaccine (Gardasil®) Group (Month 7)|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404985|NCT00496626|O2|Outcome|Placebo Group (Day 1)|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404986|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group (Day 1)|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404987|NCT00496626|E2|Reported Event|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404988|NCT00496626|E1|Reported Event|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
404989|NCT00496730|B3|Baseline|Total|Total of all reporting groups
404990|NCT00496730|B2|Baseline|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
404991|NCT00496730|B1|Baseline|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
406275|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
405001|NCT00496730|E1|Reported Event|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
405002|NCT00496769|B3|Baseline|Total|Total of all reporting groups
405003|NCT00496769|B2|Baseline|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
405004|NCT00496769|B1|Baseline|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405005|NCT00496769|P2|Participant Flow|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
405006|NCT00496769|P1|Participant Flow|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405007|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
405008|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405009|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
405010|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405011|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
405012|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405013|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
405014|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405015|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
405016|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405017|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion
405018|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405019|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
405020|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405021|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
405022|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405023|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
405095|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
405096|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
405097|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
425887|NCT00542425|O5|Outcome|Teriparatide|
405108|NCT00496873|P1|Participant Flow|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
405024|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405025|NCT00496769|E2|Reported Event|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
405026|NCT00496769|E1|Reported Event|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
405027|NCT00496782|B3|Baseline|Total|Total of all reporting groups
405028|NCT00496782|B2|Baseline|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405029|NCT00496782|B1|Baseline|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405030|NCT00496782|P2|Participant Flow|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405031|NCT00496782|P1|Participant Flow|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405032|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405033|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405034|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405035|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405036|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405037|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405038|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405039|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405098|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
405040|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405041|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405042|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405043|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405044|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405045|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405046|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405047|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405048|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405049|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405050|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405051|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405052|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405053|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405099|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
405100|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
405101|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
405102|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
405054|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405055|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405056|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405057|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405058|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405059|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405060|NCT00496782|E2|Reported Event|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
405061|NCT00496782|E1|Reported Event|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
405062|NCT00496808|B1|Baseline|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
405063|NCT00496808|P1|Participant Flow|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
405064|NCT00496808|O1|Outcome|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
405065|NCT00496808|O1|Outcome|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
405066|NCT00496808|E1|Reported Event|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
405067|NCT00496834|B3|Baseline|Total|Total of all reporting groups
405068|NCT00496834|B2|Baseline|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or
Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)."
405069|NCT00496834|B1|Baseline|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).
405070|NCT00496834|P2|Participant Flow|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or
Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)."
405071|NCT00496834|P1|Participant Flow|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).
405072|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or
Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
405103|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
405104|NCT00496860|E3|Reported Event|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
405105|NCT00496860|E2|Reported Event|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
405106|NCT00496860|E1|Reported Event|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
405073|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
405074|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or
Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
405075|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
405076|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or
Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation."
405077|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation.
405078|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or
Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
405079|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
405080|NCT00496834|E2|Reported Event|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or
Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once."
405081|NCT00496834|E1|Reported Event|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once.
405082|NCT00496860|B4|Baseline|Total|Total of all reporting groups
405083|NCT00496860|B3|Baseline|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
405084|NCT00496860|B2|Baseline|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
405085|NCT00496860|B1|Baseline|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
405086|NCT00496860|P3|Participant Flow|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
405087|NCT00496860|P2|Participant Flow|ALT-801 0.040 mg/kg/ Dose|0.040 mg/kg/dose of ALT-801
405088|NCT00496860|P1|Participant Flow|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
405089|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
405090|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
405091|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
405092|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
405093|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
405094|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
425888|NCT00542425|O4|Outcome|BA058 80 µg|
405109|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
405110|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
405111|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
405112|NCT00496873|E1|Reported Event|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
405113|NCT00496964|B3|Baseline|Total|Total of all reporting groups
405114|NCT00496964|B2|Baseline|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
405115|NCT00496964|B1|Baseline|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
405116|NCT00496964|P2|Participant Flow|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
405117|NCT00496964|P1|Participant Flow|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
405118|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
405119|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
405120|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
405121|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
405122|NCT00496964|E2|Reported Event|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
405123|NCT00496964|E1|Reported Event|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
405124|NCT00497055|B3|Baseline|Total|Total of all reporting groups
405125|NCT00497055|B2|Baseline|Placebo|placebo daily for 3 months
405126|NCT00497055|B1|Baseline|Aripiprazole|aripiprazole daily for 3 months
405127|NCT00497055|P2|Participant Flow|Placebo|Placebo (for Aripiprazole) 5mg daily for week one. Placebo (for Aripiprazole) 10mg daily for week two. Placebo (for Aripiprazole) 20mg daily for weeks three through twelve.
405128|NCT00497055|P1|Participant Flow|Aripiprazole|Aripiprazole 5mg daily for week one. Aripiprazole 10mg daily for week two. Aripiprazole 20mg daily for weeks three through twelve.
405129|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
405130|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
405131|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
405132|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
405133|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
405134|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
405135|NCT00497055|E2|Reported Event|Placebo|placebo daily for 3 months
405136|NCT00497055|E1|Reported Event|Aripiprazole|aripiprazole daily for 3 months
405137|NCT00497081|B3|Baseline|Total|Total of all reporting groups
405138|NCT00497081|B2|Baseline|Placebo Comparator:|placebo 30 mg daily for 3 months
405139|NCT00497081|B1|Baseline|Active Comparator:|mirtazapine 30 mg daily for 3 months
405140|NCT00497081|P2|Participant Flow|Placebo Comparator:|placebo 30 mg daily for 3 months
405141|NCT00497081|P1|Participant Flow|Active Comparator:|mirtazapine 30 mg daily for 3 months
405142|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
405143|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
405144|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
405145|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
405146|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
405147|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
405148|NCT00497081|E2|Reported Event|Placebo Comparator:|placebo 30 mg daily for 3 months
405149|NCT00497081|E1|Reported Event|Active Comparator:|mirtazapine 30 mg daily for 3 months
405150|NCT00489970|B3|Baseline|Total|Total of all reporting groups
405151|NCT00489970|B2|Baseline|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405152|NCT00489970|B1|Baseline|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405153|NCT00489970|P2|Participant Flow|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405154|NCT00489970|P1|Participant Flow|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405155|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405156|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405157|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405158|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405159|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405160|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
407301|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
405161|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405162|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405163|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405164|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405165|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405166|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405167|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405168|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405169|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405170|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405171|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405172|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405173|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405174|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405175|NCT00489970|E2|Reported Event|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
405176|NCT00489970|E1|Reported Event|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
405177|NCT00490009|B1|Baseline|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
405178|NCT00490009|P1|Participant Flow|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
405179|NCT00490009|O1|Outcome|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
405180|NCT00490009|O1|Outcome|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
405181|NCT00490009|O1|Outcome|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA-approved regimen for other indications.
405182|NCT00490009|E1|Reported Event|Bexxar + Tylenol + Benadryl + SSKI|Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. Bexxar is patient specific: 75 cGy whole body patients with platelet count of 150,000/mm³ and 65 cGy for patients with platelet count less than 150,000/mm³, IV
405183|NCT00490022|B3|Baseline|Total|Total of all reporting groups
405184|NCT00490022|B2|Baseline|DHT Gel|DHT gel (70 mg/day) for one month
405185|NCT00490022|B1|Baseline|Placebo DHT Gel|Placebo gel for one month
405186|NCT00490022|P2|Participant Flow|DHT Gel|DHT gel (70 mg/day) for one month
405187|NCT00490022|P1|Participant Flow|Placebo DHT Gel|Placebo gel for one month
405188|NCT00490022|O2|Outcome|DHT Gel|DHT gel (70 mg/day) for one month
405189|NCT00490022|O1|Outcome|Placebo DHT Gel|Placebo gel for one month
405190|NCT00490022|O2|Outcome|DHT Gel|DHT gel (70 mg/day) for one month
405191|NCT00490022|O1|Outcome|Placebo DHT Gel|Placebo gel for one month
405192|NCT00490022|E2|Reported Event|DHT Gel|DHT gel (70 mg/day) for one month
405193|NCT00490022|E1|Reported Event|Placebo DHT Gel|Placebo gel for one month
405194|NCT00490035|B5|Baseline|Total Title|
405195|NCT00490035|B4|Baseline|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405196|NCT00490035|B3|Baseline|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405197|NCT00490035|B2|Baseline|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405198|NCT00490035|B1|Baseline|Placebo|Matching Placebo tablets administered twice a day
405199|NCT00490035|P4|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405200|NCT00490035|P3|Participant Flow|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405201|NCT00490035|P2|Participant Flow|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405202|NCT00490035|P1|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
405203|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405204|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405207|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405208|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405209|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405210|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405211|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405212|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405213|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405214|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405215|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405216|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405217|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405218|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405219|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405220|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405221|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405222|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405223|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405224|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405225|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405226|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405227|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405228|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405229|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405230|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405231|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405232|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405233|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405234|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405235|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405236|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405237|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405238|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405239|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405240|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405241|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405242|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405243|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405244|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405245|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405246|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405247|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405248|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405249|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405250|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405251|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405252|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405253|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405254|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405255|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405256|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405257|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405258|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405259|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405260|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405261|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405262|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
425889|NCT00542425|O3|Outcome|BA058 40 µg|
405263|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405264|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405265|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405266|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405267|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405268|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405269|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405270|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405271|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405272|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405273|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405274|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405275|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405276|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405277|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405278|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405279|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405280|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405281|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405282|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405283|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405284|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405285|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405286|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405287|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405288|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405289|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405290|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405291|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405292|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405293|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405294|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
405295|NCT00490035|E4|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
405296|NCT00490035|E3|Reported Event|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
405297|NCT00490035|E2|Reported Event|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
405298|NCT00490035|E1|Reported Event|Placebo|Matching Placebo tablets administered twice a day
405299|NCT00490061|B1|Baseline|Radiotherapy (Radiation) and Lapatinib|"1500mg/d once daily oral lapatinib administration plus Intensity Modulated Radio Therapy (IMRT) delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
Lapatinib: 1500 mg po daily orally
Radiotherapy (radiation): Standard of Care
G.E. Healthcare 1.5T MR, systems revision 12.0 M5: Standard of Care, used to deliver IMRT
PET/CT: A subset of patients received imaging before and after treatment."
405300|NCT00490061|P1|Participant Flow|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
405301|NCT00490061|O1|Outcome|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
405302|NCT00490061|O1|Outcome|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
405303|NCT00490061|E1|Reported Event|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
405304|NCT00490100|B1|Baseline|Treatment|
405305|NCT00490100|P1|Participant Flow|Treatment|Participants are young males with X-linked severe combined immunodeficiency complicated by growth failure. The participants will receive Insulin-like Growth Facor (Increlex) twice a day for up to 2 years.
405306|NCT00490100|O1|Outcome|Treatment|Participants are young males with X-linked severe combined immunodeficiency complicated by growth failure. The participants will receive Insulin-like Growth Facor (Increlex) twice a day for up to 2 years.
405307|NCT00490100|O1|Outcome|Treatment|"XSCID patients with growth failre treated with Increlex, recombinant human IGF-1.
Increlex"
405308|NCT00490100|E1|Reported Event|Treatment|
405309|NCT00490139|B5|Baseline|Total|Total of all reporting groups
405414|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
405369|NCT00490477|O2|Outcome|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
405370|NCT00490477|O1|Outcome|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
407302|NCT00505284|O1|Outcome|Placebo|
405310|NCT00490139|B4|Baseline|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405311|NCT00490139|B3|Baseline|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405312|NCT00490139|B2|Baseline|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405313|NCT00490139|B1|Baseline|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405314|NCT00490139|P4|Participant Flow|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405315|NCT00490139|P3|Participant Flow|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405316|NCT00490139|P2|Participant Flow|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405317|NCT00490139|P1|Participant Flow|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405362|NCT00490269|E2|Reported Event|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
406276|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
405318|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405319|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405320|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405321|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405322|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405323|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405324|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405325|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405363|NCT00490269|E1|Reported Event|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
405364|NCT00490477|B3|Baseline|Total|Total of all reporting groups
405326|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405327|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405328|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405329|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405330|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405331|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405332|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405333|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405365|NCT00490477|B2|Baseline|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
405366|NCT00490477|B1|Baseline|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
405334|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405335|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405336|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405337|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405338|NCT00490139|O4|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405339|NCT00490139|O3|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405340|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405341|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405367|NCT00490477|P2|Participant Flow|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
405368|NCT00490477|P1|Participant Flow|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
405342|NCT00490139|E4|Reported Event|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405343|NCT00490139|E3|Reported Event|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405344|NCT00490139|E2|Reported Event|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405345|NCT00490139|E1|Reported Event|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
405346|NCT00490256|B3|Baseline|Total|Total of all reporting groups
405347|NCT00490256|B2|Baseline|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
405348|NCT00490256|B1|Baseline|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
405349|NCT00490256|P2|Participant Flow|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
405350|NCT00490256|P1|Participant Flow|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
405351|NCT00490256|O2|Outcome|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
405352|NCT00490256|O1|Outcome|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
405353|NCT00490256|E2|Reported Event|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
405354|NCT00490256|E1|Reported Event|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
405355|NCT00490269|B3|Baseline|Total|Total of all reporting groups
405356|NCT00490269|B2|Baseline|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
405357|NCT00490269|B1|Baseline|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
405358|NCT00490269|P2|Participant Flow|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
405359|NCT00490269|P1|Participant Flow|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
405360|NCT00490269|O2|Outcome|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
405361|NCT00490269|O1|Outcome|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
405413|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
406277|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
405371|NCT00490477|E2|Reported Event|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
405372|NCT00490477|E1|Reported Event|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
405373|NCT00490490|B1|Baseline|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
405374|NCT00490490|P1|Participant Flow|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
405375|NCT00490490|O1|Outcome|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
405376|NCT00490490|O1|Outcome|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
405377|NCT00490490|O1|Outcome|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
405378|NCT00490490|E1|Reported Event|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
405379|NCT00490542|B3|Baseline|Total|Total of all reporting groups
405380|NCT00490542|B2|Baseline|Geodon Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
405381|NCT00490542|B1|Baseline|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
405382|NCT00490542|P2|Participant Flow|Double-blind Flexible-dose Ziprasidone Arm|Participants in this arm received a flexible dose of ziprasidone and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing for all subjects began at 20 mg twice a day and increased to between 80 and 160 mg/day total.
405383|NCT00490542|P1|Participant Flow|Double-blind Flexible-dose Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing was flexible. Dosing for all subjects was determined based on clinician judgment in an identical manner to dosing in the ziprasidone arm.
405384|NCT00490542|O2|Outcome|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
405385|NCT00490542|O1|Outcome|Ziprasidone Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
405386|NCT00490542|E2|Reported Event|Geodon Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
405387|NCT00490542|E1|Reported Event|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
405388|NCT00490555|B5|Baseline|Total|Total of all reporting groups
405389|NCT00490555|B4|Baseline|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
405390|NCT00490555|B3|Baseline|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
405391|NCT00490555|B2|Baseline|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
405392|NCT00490555|B1|Baseline|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
405393|NCT00490555|P4|Participant Flow|4) T Gel+DMPA|Testosterone 1% transdermal gel 10g, daily + placebo Dutasteride pill, daily + DMPA 300mg injection (IM)
405394|NCT00490555|P3|Participant Flow|3) T Gel+Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
405395|NCT00490555|P2|Participant Flow|2) Testosterone (T) Gel|Testosterone 1% transdermal gel 10g (Testim)+ placebo pill, daily + placebo DMPA
405396|NCT00490555|P1|Participant Flow|1) Placebo|Placebo gel + Placebo pill + placebo DMPA
405397|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
405398|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
405399|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
405400|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
405401|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
405402|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
405403|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
405404|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
405405|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
405406|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
405407|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
405408|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
405409|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
405410|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
405411|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
405412|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
405415|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
405416|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
405417|NCT00490555|E4|Reported Event|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
405418|NCT00490555|E3|Reported Event|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
405419|NCT00490555|E2|Reported Event|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
405420|NCT00490555|E1|Reported Event|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
405421|NCT00497146|B3|Baseline|Total|Total of all reporting groups
405422|NCT00497146|B2|Baseline|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405423|NCT00497146|B1|Baseline|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405424|NCT00497146|P2|Participant Flow|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405425|NCT00497146|P1|Participant Flow|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405426|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405427|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405428|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405429|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405430|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405431|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405432|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405433|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405434|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405435|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405436|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405437|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405438|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405439|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405598|NCT00500318|E1|Reported Event|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
405631|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405440|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
456453|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
405441|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405442|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405443|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405444|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405445|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405446|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405447|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405448|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405449|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405450|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405451|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405452|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405453|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405454|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405455|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405456|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405457|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405458|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405459|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405460|NCT00497146|E4|Reported Event|Placebo: Long-term Follow-up|Participants who received placebo and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405630|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405461|NCT00497146|E3|Reported Event|Paricalcitol: Long-term Follow-up|Participants who received paricalcitol and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
405462|NCT00497146|E2|Reported Event|Placebo: Treatment Period|Participants received 2 placebo capsules once a day for up to 48 weeks.
405463|NCT00497146|E1|Reported Event|Paricalcitol: Treatment Period|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks.
405464|NCT00497198|B3|Baseline|Total|Total of all reporting groups
405465|NCT00497198|B2|Baseline|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
405466|NCT00497198|B1|Baseline|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
405467|NCT00497198|P2|Participant Flow|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
405468|NCT00497198|P1|Participant Flow|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
405469|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
405470|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
405471|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
405472|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
405473|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
405474|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
405475|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
405476|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
405477|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
405478|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
405479|NCT00497198|E2|Reported Event|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
405480|NCT00497198|E1|Reported Event|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
405481|NCT00499863|B3|Baseline|Total|Total of all reporting groups
405482|NCT00499863|B2|Baseline|Placebo (PTS)|Placebo Transdermal System
405483|NCT00499863|B1|Baseline|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405484|NCT00499863|P2|Participant Flow|Placebo (PTS)|Placebo Transdermal System
405485|NCT00499863|P1|Participant Flow|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405486|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405487|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405488|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405489|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405490|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405491|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405492|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405493|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405494|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405495|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405496|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405497|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405498|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405499|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405500|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405501|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405502|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405503|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405504|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405505|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405506|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405507|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405508|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
405509|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405510|NCT00499863|E2|Reported Event|Placebo (PTS)|Placebo Transdermal System
405511|NCT00499863|E1|Reported Event|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
405512|NCT00499889|B1|Baseline|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
405539|NCT00500110|E1|Reported Event|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
405540|NCT00500149|B1|Baseline|Entire Study Population|
405541|NCT00500149|P2|Participant Flow|Placebo First|Matching placebo was given orally once daily for 1 week in the first intervention and Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the second intervention
405513|NCT00499889|P1|Participant Flow|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
405514|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
405515|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
405516|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
405517|NCT00499889|E1|Reported Event|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
405518|NCT00499915|B3|Baseline|Total|Total of all reporting groups
405519|NCT00499915|B2|Baseline|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.
Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
405520|NCT00499915|B1|Baseline|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.
Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
405521|NCT00499915|P2|Participant Flow|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.
Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
405522|NCT00499915|P1|Participant Flow|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.
Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
405523|NCT00499915|O2|Outcome|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.
Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
405524|NCT00499915|O1|Outcome|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.
Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
405525|NCT00499915|E2|Reported Event|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.
Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
405526|NCT00499915|E1|Reported Event|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.
Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
405527|NCT00500071|B1|Baseline|Vyvanse|Lisdexamfetamine dimesylate (LDX)
405528|NCT00500071|P1|Participant Flow|Vyvanse|Lisdexamfetamine dimesylate (LDX)
405529|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
405530|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
405531|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
405532|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
405533|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
405534|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
405535|NCT00500071|E1|Reported Event|Vyvanse|Lisdexamfetamine dimesylate (LDX)
405536|NCT00500110|B1|Baseline|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
405537|NCT00500110|P1|Participant Flow|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
405538|NCT00500110|O1|Outcome|Treatment|
405594|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
405751|NCT00501046|O2|Outcome|Placebo|Placebo: 9g /day (3 times a day)
405542|NCT00500149|P1|Participant Flow|Vyvanse First|Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the first intervention and matching placebo was given orally once daily for 1 week in the second intervention
405543|NCT00500149|O2|Outcome|Placebo|Matching placebo
405544|NCT00500149|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
405545|NCT00500149|O2|Outcome|Placebo|Matching placebo
405546|NCT00500149|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
405547|NCT00500149|E2|Reported Event|Placebo|
405548|NCT00500149|E1|Reported Event|Vyvanse|
405549|NCT00500240|B3|Baseline|Total|Total of all reporting groups
405550|NCT00500240|B2|Baseline|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
405551|NCT00500240|B1|Baseline|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
405552|NCT00500240|P2|Participant Flow|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
405553|NCT00500240|P1|Participant Flow|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
405554|NCT00500240|O2|Outcome|Intensive Insulin|Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
405555|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin.
405556|NCT00500240|O2|Outcome|Intervention Group|Intense blood sugar management with Insulin Aspart + Insulin Glargine
405557|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin
405558|NCT00500240|O2|Outcome|Intensive Insulin|Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
405559|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin.
405560|NCT00500240|E2|Reported Event|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
405561|NCT00500240|E1|Reported Event|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
405562|NCT00500266|B1|Baseline|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
405563|NCT00500266|P1|Participant Flow|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
405564|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
405565|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
405566|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
405567|NCT00500266|E2|Reported Event|13vPnC: 6-month Follow-up|Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study.
405568|NCT00500266|E1|Reported Event|13vPnC: Visit 1 to Visit 2|Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study.
405569|NCT00500292|B4|Baseline|Total|Total of all reporting groups
405570|NCT00500292|B3|Baseline|Placebo Plus FOLFOX|placebo plus FOLFOX
405571|NCT00500292|B2|Baseline|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
405572|NCT00500292|B1|Baseline|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
405573|NCT00500292|P3|Participant Flow|Placebo Plus FOLFOX|placebo plus FOLFOX
405574|NCT00500292|P2|Participant Flow|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
405575|NCT00500292|P1|Participant Flow|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
405576|NCT00500292|O3|Outcome|Placebo Plus FOLFOX|placebo plus FOLFOX
405577|NCT00500292|O2|Outcome|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
405578|NCT00500292|O1|Outcome|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
405579|NCT00500292|E3|Reported Event|Placebo Plus FOLFOX|placebo plus FOLFOX
405580|NCT00500292|E2|Reported Event|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
405581|NCT00500292|E1|Reported Event|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
405582|NCT00500318|B3|Baseline|Total|Total of all reporting groups
405583|NCT00500318|B2|Baseline|Placebo|Dose-matched placebo, oral inhalation, once per day.
405584|NCT00500318|B1|Baseline|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
405585|NCT00500318|P2|Participant Flow|Placebo|Dose-matched placebo, oral inhalation, once per day.
405586|NCT00500318|P1|Participant Flow|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
405587|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
405588|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
405589|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
405590|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
405591|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
405592|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
405593|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
405752|NCT00501046|O1|Outcome|AST-120|AST-120: 9g /day (3 times a day)
405599|NCT00500357|B1|Baseline|13vPnC (Vax 3 Follow-up / NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
405600|NCT00500357|P1|Participant Flow|13vPnC (Vax 3 Follow-up / NCT00500357)|Administered 13vPnC 0.5 milliliters (mL) intramuscularly (IM) at Year 0 (Vaccination 1 [Vax 1]) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
405601|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
405602|NCT00500357|O1|Outcome|13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).
405603|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
405604|NCT00500357|O1|Outcome|13vPnC (Vax 1 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
405605|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
405606|NCT00500357|O1|Outcome|13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).
405607|NCT00500357|O1|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
405608|NCT00500357|O1|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
405609|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
405610|NCT00500357|O1|Outcome|13vPnC (Vax 1 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
405611|NCT00500357|E7|Reported Event|13vPnC-AlPO4/23vPS (After Vax 2 Core Study)|Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
405612|NCT00500357|E6|Reported Event|13vPnC+AlPO4/23vPS (After Vax 2 Core Study)|Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
405613|NCT00500357|E5|Reported Event|13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)|Administered 13vPnC + AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 13vPnC+AlPO4 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
405614|NCT00500357|E4|Reported Event|23vPS (After Vax 1 Core Study)|Administered 23vPS 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
405615|NCT00500357|E3|Reported Event|13vPnC-AlPO4 (After Vax 1 Core Study)|Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
405616|NCT00500357|E2|Reported Event|13vPnC+AlPO4 (After Vax 1 Core Study)|Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
405617|NCT00500357|E1|Reported Event|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)|"Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
For 13vPnC / 23vPS / 13vPnC (Vax 3 follow-up study) Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Any Local Reactions N=41; systematic (solicited) Any Systemic Events N=46."
405618|NCT00500370|B3|Baseline|Total|Total of all reporting groups
405619|NCT00500370|B2|Baseline|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405620|NCT00500370|B1|Baseline|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405621|NCT00500370|P2|Participant Flow|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405622|NCT00500370|P1|Participant Flow|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405623|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405624|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405625|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405626|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405627|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405628|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405629|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405753|NCT00501046|E2|Reported Event|Placebo|Placebo: 9g /day (3 times a day)
405632|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
407430|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
405633|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405634|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405635|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405636|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405637|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405638|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405639|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405640|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405641|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405642|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405643|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405644|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405645|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405646|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405647|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405648|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405649|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405650|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405651|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405652|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405653|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405654|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405655|NCT00500370|E2|Reported Event|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
405656|NCT00500370|E1|Reported Event|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
405657|NCT00500448|B3|Baseline|Total|Total of all reporting groups
405658|NCT00500448|B2|Baseline|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
405659|NCT00500448|B1|Baseline|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
405660|NCT00500448|P2|Participant Flow|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
405661|NCT00500448|P1|Participant Flow|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
405662|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
405663|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
405664|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
405665|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
405666|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
405667|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
405668|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
405669|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
405670|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
405671|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
405672|NCT00500448|E2|Reported Event|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
405673|NCT00500448|E1|Reported Event|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
405674|NCT00500539|B1|Baseline|Omalizumab|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
405675|NCT00500539|P1|Participant Flow|Omalizumab|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
405676|NCT00500539|O1|Outcome|Follow-up Period|Participants were assessed at 16 weeks after the last dose of study drug
405677|NCT00500539|O1|Outcome|Treatment Period|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
405678|NCT00500539|O1|Outcome|Follow-up Period|Participants were evaluated at 16 weeks after the last dose of study drug.
405679|NCT00500539|E2|Reported Event|Omalizumab Follow up Period|Participants were assessed at 16 weeks after the last dose of study drug
405680|NCT00500539|E1|Reported Event|Omalizumab Treatment Period|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
405681|NCT00500578|B3|Baseline|Total|Total of all reporting groups
405682|NCT00500578|B2|Baseline|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
405683|NCT00500578|B1|Baseline|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
405684|NCT00500578|P2|Participant Flow|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
405685|NCT00500578|P1|Participant Flow|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
405686|NCT00500578|O2|Outcome|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
405687|NCT00500578|O1|Outcome|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
405688|NCT00500578|E2|Reported Event|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
405689|NCT00500578|E1|Reported Event|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
405690|NCT00500656|B5|Baseline|Total|Total of all reporting groups
405691|NCT00500656|B4|Baseline|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
405692|NCT00500656|B3|Baseline|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
405693|NCT00500656|B2|Baseline|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
405694|NCT00500656|B1|Baseline|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
405695|NCT00500656|P4|Participant Flow|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
405696|NCT00500656|P3|Participant Flow|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
405697|NCT00500656|P2|Participant Flow|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
405698|NCT00500656|P1|Participant Flow|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
405699|NCT00500656|O2|Outcome|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
405700|NCT00500656|O1|Outcome|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
405701|NCT00500656|O2|Outcome|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
405702|NCT00500656|O1|Outcome|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
405703|NCT00500656|E6|Reported Event|Open Label Extension Phase(Untreated Patients at the Baseline|This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
405704|NCT00500656|E5|Reported Event|Open Label Extension Phase (Subjects w/ Laryngeal Attack)|This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase and Open label extension phase.
405754|NCT00501046|E1|Reported Event|AST-120|AST-120: 9g /day (3 times a day)
425890|NCT00542425|O2|Outcome|BA058 20 µg|
406904|NCT00503776|E1|Reported Event|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
405705|NCT00500656|E4|Reported Event|Open Label Extension Phase- Icatibant (Previously Randomized)|Patients who were randomized to either icatibant+ oral placebo or Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the open label extension phase.
405706|NCT00500656|E3|Reported Event|Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase.
405707|NCT00500656|E2|Reported Event|Controlled Phase- Tranexamic Acid (Randomized Subjects)|Patients who were randomized to Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the controlled phase.
405708|NCT00500656|E1|Reported Event|Controlled Phase- Icatibant (Randomized Subjects )|Patients who were randomized to icatibant+ oral placebo in the controlled phase and experienced adverse events while participating in the controlled phase
405709|NCT00500682|B3|Baseline|Total|Total of all reporting groups
405710|NCT00500682|B2|Baseline|Placebo|Placebo: 9g /day (3 times a day)
405711|NCT00500682|B1|Baseline|AST-120|AST-120: 9g /day (3 times a day)
405712|NCT00500682|P2|Participant Flow|Placebo|Placebo: 9g /day (3 times a day)
405713|NCT00500682|P1|Participant Flow|AST-120|AST-120: 9g /day (3 times a day)
405714|NCT00500682|O2|Outcome|Placebo|Placebo: 9g /day (3 times a day)
405715|NCT00500682|O1|Outcome|AST-120|AST-120: 9g /day (3 times a day)
405716|NCT00500682|E2|Reported Event|Placebo|Placebo: 9g /day (3 times a day)
405717|NCT00500682|E1|Reported Event|AST-120|AST-120: 9g /day (3 times a day)
405718|NCT00500760|B3|Baseline|Total|Total of all reporting groups
405719|NCT00500760|B2|Baseline|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
405720|NCT00500760|B1|Baseline|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
405721|NCT00500760|P2|Participant Flow|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
405722|NCT00500760|P1|Participant Flow|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
405723|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
405724|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
405725|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
405726|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
405727|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
405728|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
405729|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
405730|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
405731|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
405732|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
405733|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
405734|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
405735|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
405736|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
405737|NCT00500760|E2|Reported Event|Chemotherapy Plus Radiotherapy|
405738|NCT00500760|E1|Reported Event|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
405739|NCT00501007|B1|Baseline|Diagnosis|Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder
405740|NCT00501007|P2|Participant Flow|Smokers With Schizophrenia / Schizoaffective Disorder|Smokers meeting criteria for schizophrenia or schizoaffective disorder
405741|NCT00501007|P1|Participant Flow|Non-psychiatric Smokers|Smokers without a diagnosis of schizophrenia or schizoaffective disorder
405742|NCT00501007|O1|Outcome|Smoking Cessation|Participants received tobacco dependence treatment
405743|NCT00501007|O2|Outcome|Non-psychiatric Group|Smokers NOT meeting criteria for schizophrenia, schizophrenia, bipolar disorder.
405744|NCT00501007|O1|Outcome|Schizophrenia or Schizoaffective Disorder|Smokers meeting Diagnostic and Statistical Manual criteria for Schizophrenia or Schizoaffective Disorder
405745|NCT00501007|E1|Reported Event|Diagnosis|Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder
405746|NCT00501046|B3|Baseline|Total|Total of all reporting groups
405747|NCT00501046|B2|Baseline|Placebo|Placebo: 9g /day (3 times a day)
405748|NCT00501046|B1|Baseline|AST-120|AST-120: 9g /day (3 times a day)
405749|NCT00501046|P2|Participant Flow|Placebo|Placebo: 9g /day (3 times a day)
405750|NCT00501046|P1|Participant Flow|AST-120|AST-120: 9g /day (3 times a day)
425891|NCT00542425|O1|Outcome|Placebo|
405755|NCT00501085|B1|Baseline|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
405756|NCT00501085|P1|Participant Flow|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
405757|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
405758|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
405759|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
405760|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
405761|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
405762|NCT00501085|E1|Reported Event|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
405763|NCT00501228|B1|Baseline|Filgrastim Injections|
405764|NCT00501228|P1|Participant Flow|Filgrastim Injections|
405765|NCT00501228|O1|Outcome|Filgrastim Injections|
405766|NCT00501228|E1|Reported Event|Filgrastim Injections|
405767|NCT00501293|B3|Baseline|Total|Total of all reporting groups
405768|NCT00501293|B2|Baseline|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405769|NCT00501293|B1|Baseline|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405770|NCT00501293|P2|Participant Flow|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405771|NCT00501293|P1|Participant Flow|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405772|NCT00501293|O1|Outcome|Antecedent MTS and Antecedent Placebo|Methylphenidate Transdermal System and Placebo Patch
405773|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405774|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405775|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405776|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405777|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405778|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405779|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405780|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405781|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405782|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405783|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405784|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405785|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405786|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405787|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405788|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405789|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
425892|NCT00542425|O5|Outcome|Teriparatide|
405790|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405791|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405792|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405793|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405794|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405795|NCT00501293|E2|Reported Event|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405796|NCT00501293|E1|Reported Event|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
405797|NCT00501345|B1|Baseline|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
405798|NCT00501345|P1|Participant Flow|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
405799|NCT00501345|O1|Outcome|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
405800|NCT00501345|E1|Reported Event|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
405801|NCT00501540|B1|Baseline|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.
Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
405802|NCT00501540|P1|Participant Flow|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.
Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
405803|NCT00501540|O1|Outcome|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.
Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
405804|NCT00501540|O1|Outcome|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.
Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
405805|NCT00501540|O1|Outcome|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.
Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
405806|NCT00501540|E1|Reported Event|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.
Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
405807|NCT00501592|B4|Baseline|Total|Total of all reporting groups
405808|NCT00501592|B3|Baseline|Placebo|Once daily by mouth
405809|NCT00501592|B2|Baseline|50 mg INT-747|Once daily by mouth
405810|NCT00501592|B1|Baseline|25 mg INT-747|Once daily by mouth
405811|NCT00501592|P3|Participant Flow|Placebo|Once daily by mouth
405812|NCT00501592|P2|Participant Flow|50 mg INT-747|Once daily by mouth
405813|NCT00501592|P1|Participant Flow|25 mg INT-747|Once daily by mouth
405814|NCT00501592|O3|Outcome|Placebo|Once daily by mouth
405815|NCT00501592|O2|Outcome|50 mg INT-747|Once daily by mouth
405816|NCT00501592|O1|Outcome|25 mg INT-747|Once daily by mouth
405817|NCT00501592|O3|Outcome|Placebo|Once daily by mouth
405818|NCT00501592|O2|Outcome|50 mg INT-747|Once daily by mouth
405819|NCT00501592|O1|Outcome|25 mg INT-747|Once daily by mouth
405820|NCT00501592|E3|Reported Event|Placebo|Once daily by mouth
405821|NCT00501592|E2|Reported Event|50 mg INT-747|Once daily by mouth
405822|NCT00501592|E1|Reported Event|25 mg INT-747|Once daily by mouth
405823|NCT00501631|B3|Baseline|Total|Total of all reporting groups
405824|NCT00501631|B2|Baseline|Placebo for VIVITROL 380 mg|All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
405887|NCT00501969|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
405825|NCT00501631|B1|Baseline|VIVITROL 380 mg|Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
405826|NCT00501631|P2|Participant Flow|Placebo for VIVITROL 380 mg|All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
405827|NCT00501631|P1|Participant Flow|VIVITROL 380 mg|Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
405828|NCT00501631|O2|Outcome|Placebo|
405829|NCT00501631|O1|Outcome|Vivitrol|
405830|NCT00501631|E2|Reported Event|Placebo for VIVITROL 380 mg (Double-blind Period)|
405831|NCT00501631|E1|Reported Event|VIVITROL 380 mg (Double-blind Period)|
405832|NCT00501644|B1|Baseline|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
405833|NCT00501644|P1|Participant Flow|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
405834|NCT00501644|O1|Outcome|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
405835|NCT00501644|E1|Reported Event|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
405836|NCT00501852|B1|Baseline|Overall Study|
405837|NCT00501852|P1|Participant Flow|Overall Study|
405838|NCT00501852|O6|Outcome|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405839|NCT00501852|O5|Outcome|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405840|NCT00501852|O4|Outcome|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405841|NCT00501852|O3|Outcome|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405842|NCT00501852|O2|Outcome|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405843|NCT00501852|O1|Outcome|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405844|NCT00501852|O6|Outcome|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405845|NCT00501852|O5|Outcome|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405846|NCT00501852|O4|Outcome|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405847|NCT00501852|O3|Outcome|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405848|NCT00501852|O2|Outcome|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405849|NCT00501852|O1|Outcome|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405850|NCT00501852|E6|Reported Event|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405851|NCT00501852|E5|Reported Event|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
406091|NCT00494091|E2|Reported Event|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
405852|NCT00501852|E4|Reported Event|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405853|NCT00501852|E3|Reported Event|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405854|NCT00501852|E2|Reported Event|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405855|NCT00501852|E1|Reported Event|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
405856|NCT00501891|B1|Baseline|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
405857|NCT00501891|P1|Participant Flow|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
405858|NCT00501891|O1|Outcome|Bevacizumab and Metromonic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
405859|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
405860|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
405861|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
405862|NCT00501891|E1|Reported Event|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
405863|NCT00501943|B3|Baseline|Total|Total of all reporting groups
405864|NCT00501943|B2|Baseline|Placebo|"placebo
1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
405865|NCT00501943|B1|Baseline|Riluzole|"Riluzole
Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
405866|NCT00501943|P2|Participant Flow|Placebo|"placebo
1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
405867|NCT00501943|P1|Participant Flow|Riluzole|"Riluzole
Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
405868|NCT00501943|O2|Outcome|Placebo|"placebo
Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
405869|NCT00501943|O1|Outcome|Riluzole|"Riluzole
Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
405870|NCT00501943|O2|Outcome|Placebo|"placebo
Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
405871|NCT00501943|O1|Outcome|Riluzole|"Riluzole
Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
405872|NCT00501943|O2|Outcome|Placebo|"placebo
Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
405873|NCT00501943|O1|Outcome|Riluzole|"Riluzole
Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
405874|NCT00501943|O2|Outcome|Placebo|"placebo
Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
405875|NCT00501943|O1|Outcome|Riluzole|"Riluzole
Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
405876|NCT00501943|O2|Outcome|Placebo|"placebo
Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
405877|NCT00501943|O1|Outcome|Riluzole|"Riluzole
Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
405878|NCT00501943|O2|Outcome|Placebo|"placebo
1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
405879|NCT00501943|O1|Outcome|Riluzole|"Riluzole
Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
405880|NCT00501943|E2|Reported Event|Placebo|"placebo
1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
405881|NCT00501943|E1|Reported Event|Riluzole|"Riluzole
Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
405882|NCT00501969|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
405883|NCT00501969|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
405884|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
405885|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
405886|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
406156|NCT00494299|B3|Baseline|Total|Total of all reporting groups
405888|NCT00501995|B1|Baseline|IV Cyclophosphamide (50 mg/kg)|This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)
405889|NCT00501995|P1|Participant Flow|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .
IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
405890|NCT00501995|O1|Outcome|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .
IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
405891|NCT00501995|O1|Outcome|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .
IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
405892|NCT00501995|E1|Reported Event|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .
IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
405893|NCT00502203|B1|Baseline|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
405894|NCT00502203|P1|Participant Flow|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
405895|NCT00502203|O1|Outcome|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
405896|NCT00502203|E1|Reported Event|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
405897|NCT00502216|B3|Baseline|Total|Total of all reporting groups
405898|NCT00502216|B2|Baseline|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
405899|NCT00502216|B1|Baseline|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
405900|NCT00502216|P2|Participant Flow|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
405901|NCT00502216|P1|Participant Flow|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
405902|NCT00502216|O2|Outcome|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
405903|NCT00502216|O1|Outcome|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
405904|NCT00502216|E2|Reported Event|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
405905|NCT00502216|E1|Reported Event|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
405906|NCT00502242|B3|Baseline|Total|Total of all reporting groups
405907|NCT00502242|B2|Baseline|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405908|NCT00502242|B1|Baseline|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405909|NCT00502242|P2|Participant Flow|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
406037|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
406038|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406039|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
405910|NCT00502242|P1|Participant Flow|Ramipril|Participants were receiving cyclosporine (CsA) or tacrolimus (TAC) and either mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) or steroids dosed per center’s standard of care. Participants received ramipril, 5 or 10 milligrams per day (mg/d) orally (PO). 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of sirolimus [SRL] initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 nanograms per milliliter [ng/mL] less than [<]1 year post-transplant [PT], 5-15 ng/mL greater than or equal to [≥]1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if urinary protein to creatinine ratio (U p/c) was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405911|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405912|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405913|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405914|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405915|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405916|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405917|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405918|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
406040|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406041|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
405919|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405920|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405921|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405922|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405923|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405924|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405925|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405926|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405927|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
406042|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406043|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
406044|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406278|NCT00502320|E2|Reported Event|Placebo|inactive sugar pill taken by mouth nightly
405928|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405929|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405930|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405931|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405932|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405933|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405934|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405935|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405936|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
406045|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
406046|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406047|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
425893|NCT00542425|O4|Outcome|BA058 80 µg|
405937|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405938|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405939|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405940|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405941|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405942|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405943|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405944|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405945|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
406048|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406049|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
406050|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406279|NCT00502320|E1|Reported Event|Ramelteon|8 mg pill taken by mouth nightly
405946|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405947|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405948|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405949|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405950|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405951|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405952|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405953|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405954|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
406051|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
406052|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406053|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
405955|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405956|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405957|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405958|NCT00502242|E2|Reported Event|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405959|NCT00502242|E1|Reported Event|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
405960|NCT00493454|B1|Baseline|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
405961|NCT00493454|P1|Participant Flow|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
405962|NCT00493454|O1|Outcome|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
405963|NCT00493454|E1|Reported Event|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
405964|NCT00493636|B3|Baseline|Total|Total of all reporting groups
405965|NCT00493636|B2|Baseline|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405966|NCT00493636|B1|Baseline|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
406054|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406055|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
406056|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406157|NCT00494299|B2|Baseline|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
405967|NCT00493636|P2|Participant Flow|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405968|NCT00493636|P1|Participant Flow|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405969|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405970|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405971|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405972|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405973|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405974|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405975|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
406057|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
406267|NCT00502320|B3|Baseline|Total|Total of all reporting groups
405976|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405977|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405978|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405979|NCT00493636|E2|Reported Event|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405980|NCT00493636|E1|Reported Event|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
405981|NCT00493649|B1|Baseline|TC+H|docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
405982|NCT00493649|P1|Participant Flow|TC+H|This is a nonrandomized, noncomparative, open-label Phase II study. On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive docetaxel (Taxotere) 75 mg/m^2 IV plus cyclophosphamide (Cytoxan) 600 mg/m^2 IV, plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, Day 1, Cycle 1 only) and 2 mg/kg IV (on Days 1, 8, and 15) thereafter. Subsequent cycles of therapy will continue until a total of 4 cycles of TC+H have been completed. Then, patients will continue to receive trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care.
405983|NCT00493649|O2|Outcome|cMYC-nonamplified Group|FISH ratio of cMYC gene copy number was less than 2.
405984|NCT00493649|O1|Outcome|cMYC-amplified Group|FISH ratio of cMYC gene copy number was 2 or greater.
405985|NCT00493649|O2|Outcome|cMYC-nonamplified Group|FISH ratio of cMYC gene copy number was less than 2.
405986|NCT00493649|O1|Outcome|cMYC-amplified Group|FISH ratio of cMYC gene copy number was 2 or greater.
405987|NCT00493649|O2|Outcome|TOP2A-nonamplified Group|FISH ratio of TOP2A gene copy number was less than 2.
405988|NCT00493649|O1|Outcome|TOP2A-amplified Group|FISH ratio of TOP2A gene copy number was 2 or greater.
405989|NCT00493649|O2|Outcome|TOP2A-nonamplified Group|FISH ratio of TOP2A gene copy number was less than 2.
405990|NCT00493649|O1|Outcome|TOP2A-amplified Group|FISH ratio of TOP2A gene copy number was 2 or greater.
405991|NCT00493649|E1|Reported Event|TC+H|docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
405992|NCT00493779|B1|Baseline|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
405993|NCT00493779|P1|Participant Flow|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
405994|NCT00493779|O1|Outcome|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
405995|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
405996|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
405997|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
405998|NCT00493779|E1|Reported Event|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
405999|NCT00493805|B1|Baseline|Total for Interventional Arm and Non Interventional Arm|
406268|NCT00502320|B2|Baseline|Placebo|inactive sugar pill taken by mouth nightly
406000|NCT00493805|P2|Participant Flow|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
406001|NCT00493805|P1|Participant Flow|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
406002|NCT00493805|O2|Outcome|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
406003|NCT00493805|O1|Outcome|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
406004|NCT00493805|O2|Outcome|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
406005|NCT00493805|O1|Outcome|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
406006|NCT00493805|E2|Reported Event|Interventional Arm HOMA IR >2|
406007|NCT00493805|E1|Reported Event|Non Interventional Arm HOMA IR <=2|
406008|NCT00493974|B3|Baseline|Total|Total of all reporting groups
406009|NCT00493974|B2|Baseline|Placebo|Matching placebo 4 times a day
406010|NCT00493974|B1|Baseline|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
406011|NCT00493974|P2|Participant Flow|Placebo|Matching placebo 4 times a day
406012|NCT00493974|P1|Participant Flow|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
406013|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
406014|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
406015|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
406016|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
406017|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
406018|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
406019|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
406020|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
406021|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
406022|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
406023|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
406024|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
406025|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
406026|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
406027|NCT00493974|E2|Reported Event|Placebo|Matching placebo 4 times a day
406028|NCT00493974|E1|Reported Event|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
406029|NCT00494013|B3|Baseline|Total|Total of all reporting groups
406030|NCT00494013|B2|Baseline|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406031|NCT00494013|B1|Baseline|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
406032|NCT00494013|P2|Participant Flow|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406033|NCT00494013|P1|Participant Flow|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
406034|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406035|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
406036|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406058|NCT00494013|E2|Reported Event|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
406059|NCT00494013|E1|Reported Event|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
406060|NCT00494026|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.
Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
406061|NCT00494026|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.
Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
406062|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.
Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
406063|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.
Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
406064|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.
Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
406065|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.
Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
406066|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.
Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
406067|NCT00494026|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.
Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
406068|NCT00494091|B3|Baseline|Total|Total of all reporting groups
406069|NCT00494091|B2|Baseline|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406070|NCT00494091|B1|Baseline|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406071|NCT00494091|P2|Participant Flow|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406072|NCT00494091|P1|Participant Flow|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406073|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406074|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406075|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406076|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406077|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406078|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406079|NCT00494091|O2|Outcome|Temsirolimus 25 mg IV|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406080|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406081|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406082|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406083|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406084|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406085|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406086|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406087|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406088|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406089|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406090|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406092|NCT00494091|E1|Reported Event|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
406093|NCT00494143|B1|Baseline|CESR, Prescribed, Conventional|all subjects were randomized to each of the three interventions
406094|NCT00494143|P6|Participant Flow|CESR, Conventional, Prescribed|The individuals in this group were randomized to the prosthetic foot sequence, CESR foot, Conventional foot followed by Prescribed prosthetic foot.
406095|NCT00494143|P5|Participant Flow|CESR, Prescribed, Conventional|This arm included the individuals who were randomized to the prosthetic foot sequence, CESR foot followed by Prescribed foot, followed by Conventional foot.
406096|NCT00494143|P4|Participant Flow|Prescribed, Conventional, CESR|This arm included individuals who were randomized to the sequence, Prescribed prosthetic foot, conventional foot, CESR foot
406097|NCT00494143|P3|Participant Flow|Prescribed, CESR, Conventional|The randomized sequence of this arm was the Prescribed prosthetic foot, followed by the CESR foot followed by the Conventional prosthetic foot
406098|NCT00494143|P2|Participant Flow|Conventional, CESR, Prescribed|The randomized sequence of prosthetic use in this arm was Conventional foot, followed by CESR foot, followed by Prescribed.
406099|NCT00494143|P1|Participant Flow|Conventional, Prescribed, CESR|this is a randomized arm where the sequence of prosthetic use was their conventional foot, followed by prescribed foot, followed by the CESR foot
406100|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|results while wearing the prescribed prosthetic foot
406101|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|results while wearing the conventional prosthetic foot
406102|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot
CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
406103|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|results with prescribed prosthetic foot
406104|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|results with the conventional prosthetic foot
406105|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot
CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
406106|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|subjects wearing the prescribed prosthetic foot
406107|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|subjects wearing the conventional prosthetic foot
406108|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot
CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
406109|NCT00494143|E3|Reported Event|Arm 2 Prescribed Prosthetic Foot|subjects randomized to the prescribed prosthetic foot
406110|NCT00494143|E2|Reported Event|Arm 1 Conventional Prosthetic Foot|subjects randomized to the conventional prosthetic foot
406111|NCT00494143|E1|Reported Event|Arm 3 CESR Prosthetic Foot|subjects randomized to the CESR prosthetic foot
406112|NCT00494221|B4|Baseline|Total|Total of all reporting groups
406113|NCT00494221|B3|Baseline|Placebo|FOLFOX + Placebo
406114|NCT00494221|B2|Baseline|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
406115|NCT00494221|B1|Baseline|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
406116|NCT00494221|P3|Participant Flow|Placebo|FOLFOX + Placebo
406117|NCT00494221|P2|Participant Flow|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
406118|NCT00494221|P1|Participant Flow|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
406119|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
406120|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
406121|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
406122|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
406123|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
406124|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
406125|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
406126|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
406127|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
406128|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
406129|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
406130|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
406131|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
406132|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
406133|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
406134|NCT00494221|E3|Reported Event|Placebo|Placebo
406135|NCT00494221|E2|Reported Event|Cediranib 30 mg|Cediranib 30 mg
406136|NCT00494221|E1|Reported Event|Cediranib 20 mg|Cediranib 20 mg
406137|NCT00494234|B3|Baseline|Total|Total of all reporting groups
406138|NCT00494234|B2|Baseline|AZD2281 400 mg|
406139|NCT00494234|B1|Baseline|AZD2281 100 mg|
406140|NCT00494234|P2|Participant Flow|Olaparib 400 mg bd|Full Analysis Set
406141|NCT00494234|P1|Participant Flow|Olaparib 100 mg bd|Full Analysis Set
406142|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Patients who compled 6 cycles of treatment
406143|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Patients who compled 6 cycles of treatment
406144|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
406145|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
406146|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
406147|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
406148|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
406149|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
406150|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Number of responders
406151|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Number of responders
406152|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
406153|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
406154|NCT00494234|E2|Reported Event|AZD2281 400 mg|
406155|NCT00494234|E1|Reported Event|AZD2281 100 mg|
406158|NCT00494299|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
406159|NCT00494299|P2|Participant Flow|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
406160|NCT00494299|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
406161|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
406162|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
406163|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
406164|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
406165|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
406166|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
406167|NCT00494299|E2|Reported Event|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
406168|NCT00494299|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
406169|NCT00494442|B3|Baseline|Total|Total of all reporting groups
406170|NCT00494442|B2|Baseline|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
406171|NCT00494442|B1|Baseline|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
406172|NCT00494442|P2|Participant Flow|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
406173|NCT00494442|P1|Participant Flow|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
406174|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
406175|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
406176|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
406177|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
406178|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
406179|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
406180|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
406181|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
406182|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
406183|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
406184|NCT00494442|E2|Reported Event|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
406185|NCT00494442|E1|Reported Event|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
406186|NCT00494481|B3|Baseline|Total|Total of all reporting groups
406187|NCT00494481|B2|Baseline|Placebo Plus Docetaxel|placebo plus docetaxel
406188|NCT00494481|B1|Baseline|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
406189|NCT00494481|P2|Participant Flow|Placebo Plus Docetaxel|placebo plus docetaxel
406190|NCT00494481|P1|Participant Flow|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
406191|NCT00494481|O2|Outcome|Placebo Plus Docetaxel|placebo plus docetaxel
406192|NCT00494481|O1|Outcome|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
406193|NCT00494481|E2|Reported Event|Placebo Plus Docetaxel|placebo plus docetaxel
406194|NCT00494481|E1|Reported Event|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
406195|NCT00494494|B3|Baseline|Total|Total of all reporting groups
406196|NCT00494494|B2|Baseline|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
406197|NCT00494494|B1|Baseline|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
406198|NCT00494494|P2|Participant Flow|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
406199|NCT00494494|P1|Participant Flow|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
406200|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
406201|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
406202|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
406203|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
406204|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
406269|NCT00502320|B1|Baseline|Ramelteon|8 mg pill taken by mouth nightly
406205|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
406206|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
406207|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
406208|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
406209|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
406210|NCT00494494|E2|Reported Event|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
406211|NCT00494494|E1|Reported Event|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
406212|NCT00494507|B5|Baseline|Total|Total of all reporting groups
406213|NCT00494507|B4|Baseline|HOP Placebo|"Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
406214|NCT00494507|B3|Baseline|HOP Dichlorphenamide|"Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
406215|NCT00494507|B2|Baseline|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
406216|NCT00494507|B1|Baseline|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
406217|NCT00494507|P4|Participant Flow|HOP Placebo|"Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
406218|NCT00494507|P3|Participant Flow|HOP Dichlorphenamide|"Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
406219|NCT00494507|P2|Participant Flow|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
406220|NCT00494507|P1|Participant Flow|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
406221|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406222|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406223|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406224|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406225|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406226|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406227|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406228|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406229|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406230|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406231|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406232|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406233|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
406270|NCT00502320|P2|Participant Flow|Placebo|inactive sugar pill taken by mouth nightly
406271|NCT00502320|P1|Participant Flow|Ramelteon|8 mg pill taken by mouth nightly
406234|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
406235|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
406236|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
406237|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406238|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406239|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
406240|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
406241|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
406242|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
406243|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
406244|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
406245|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406246|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406247|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406248|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406249|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406250|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406251|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406252|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406253|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406254|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406255|NCT00494507|O2|Outcome|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
406256|NCT00494507|O1|Outcome|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
406257|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406258|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406259|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
406260|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
406261|NCT00494507|E6|Reported Event|HOP Open-Label Dichlorphenamide|Hypokalemic participants received Dichlorphenamide for the 52 week open-label phase.
406262|NCT00494507|E5|Reported Event|HOP Double-Blind Placebo|Hypokalemic participants were randomized to Placebo for the 9 week double-blind phase.
406263|NCT00494507|E4|Reported Event|HOP Double-Blind Dichlorphenamide|Hypokalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase.
406264|NCT00494507|E3|Reported Event|HYP Open-Label Dichlorphenamide|Hyperkalemic participants received Dichlorphenamide for the 52 week open-label phase.
406265|NCT00494507|E2|Reported Event|HYP Double-Blind Placebo|Hyperkalemic participants were randomized to Placebo for the 9 week double-blind phase.
406266|NCT00494507|E1|Reported Event|HYP Double-Blind Dichlorphenamide|Hyperkalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase.
406281|NCT00502593|B12|Baseline|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406282|NCT00502593|B11|Baseline|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406283|NCT00502593|B10|Baseline|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406284|NCT00502593|B9|Baseline|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406285|NCT00502593|B8|Baseline|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406286|NCT00502593|B7|Baseline|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406287|NCT00502593|B6|Baseline|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406288|NCT00502593|B5|Baseline|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406289|NCT00502593|B4|Baseline|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406290|NCT00502593|B3|Baseline|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406291|NCT00502593|B2|Baseline|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406292|NCT00502593|B1|Baseline|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406293|NCT00502593|P12|Participant Flow|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406294|NCT00502593|P11|Participant Flow|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406295|NCT00502593|P10|Participant Flow|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406296|NCT00502593|P9|Participant Flow|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406297|NCT00502593|P8|Participant Flow|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406298|NCT00502593|P7|Participant Flow|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406299|NCT00502593|P6|Participant Flow|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406300|NCT00502593|P5|Participant Flow|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406301|NCT00502593|P4|Participant Flow|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406845|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
406302|NCT00502593|P3|Participant Flow|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406303|NCT00502593|P2|Participant Flow|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406304|NCT00502593|P1|Participant Flow|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406305|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406306|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406307|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406308|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406309|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406310|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406311|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406312|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406313|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406314|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406315|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406316|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406317|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406318|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406319|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406320|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406321|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406322|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406323|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406324|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406325|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406326|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406327|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406328|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406329|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406330|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406331|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406332|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406333|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406334|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406335|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406336|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406337|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406338|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406339|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406340|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406341|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406342|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406343|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406344|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406345|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406346|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406347|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406348|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406349|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406350|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group Subjects Aged 6-9 Years Receive|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406351|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406352|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406353|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406354|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406355|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406356|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406357|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406358|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406359|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406360|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406361|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406362|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406363|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406364|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406365|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406366|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406367|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406368|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406369|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406370|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406371|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406372|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406373|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406374|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406375|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406376|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406377|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406378|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406379|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406380|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406381|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406382|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406383|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406384|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406385|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406386|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406387|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406388|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406389|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406390|NCT00502593|O3|Outcome|GSK1562902A–B Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406391|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406392|NCT00502593|O1|Outcome|GSK1562902A –B Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406393|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406394|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406395|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406396|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406397|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406398|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406399|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406400|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406401|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406402|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406403|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Fluarix–A 3-5Y Group
406404|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406405|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406406|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406407|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406408|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406409|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406410|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406411|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406901|NCT00503776|E4|Reported Event|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
425894|NCT00542425|O3|Outcome|BA058 40 µg|
406412|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406413|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406414|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406415|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406416|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406417|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406418|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406419|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406420|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406421|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406422|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406423|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406424|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406425|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406426|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406427|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406428|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406429|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406430|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406431|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406432|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406433|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406434|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406435|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406436|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406437|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406438|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406439|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406440|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406441|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406442|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406443|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406444|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406445|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406446|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406447|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406448|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406449|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406450|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406451|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406452|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406453|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406454|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406455|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406456|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406457|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406458|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406459|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406460|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406461|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406462|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406463|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406464|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406465|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406466|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406467|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406468|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406469|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406470|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406471|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406472|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406473|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406474|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406475|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406476|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406477|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406478|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406479|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406480|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406481|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406482|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406483|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406484|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406485|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406486|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406487|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406488|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406489|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406490|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406491|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406492|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406493|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406494|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406495|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406496|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406497|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406498|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406499|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406500|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406501|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406502|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406503|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406504|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406505|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406506|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406507|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406508|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406509|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406510|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406511|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406512|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406513|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406514|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406515|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406516|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406517|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406518|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406519|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406520|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406521|NCT00502593|O6|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406522|NCT00502593|O5|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406523|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406524|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406525|NCT00502593|O2|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406526|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406527|NCT00502593|O6|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406528|NCT00502593|O5|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406529|NCT00502593|O4|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406530|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406531|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406532|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406533|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406534|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406535|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21
406536|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21
406537|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406538|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406539|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406540|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406541|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406542|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406543|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406544|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406545|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406546|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406547|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406548|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406549|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406550|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406551|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406552|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406553|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406554|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406555|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406556|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406557|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406558|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406559|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406560|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406561|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406562|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406563|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406564|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406565|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406566|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406567|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406568|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406569|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406570|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406571|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406572|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406573|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406574|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406575|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406576|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406577|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406578|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406579|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406580|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406581|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406582|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406583|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406584|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406585|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406586|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406587|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406588|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406589|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406590|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406591|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406592|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406593|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406594|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406595|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406596|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406597|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406598|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406599|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406600|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406601|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406602|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406603|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406604|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406605|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406606|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406607|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406608|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406609|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406610|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406611|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406612|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406613|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406614|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406615|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406616|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406617|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406618|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406619|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406620|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406621|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406622|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406623|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406624|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406625|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406626|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406627|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406628|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406629|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406630|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406631|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406632|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406633|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406634|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406635|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406636|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406637|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406638|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406639|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406640|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406641|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406642|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406643|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406644|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406645|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406646|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406647|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406648|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406649|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406650|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406651|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406652|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406653|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406654|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406655|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406656|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406657|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406658|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406659|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406660|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406661|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406662|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406663|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406664|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406665|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406666|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406667|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406668|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406669|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406670|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406671|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406672|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406673|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406674|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406675|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406676|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406677|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406678|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406679|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406680|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406681|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406682|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406683|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406684|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406685|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406686|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406687|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406688|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406689|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406690|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406691|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406692|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406693|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406694|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406695|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406696|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406697|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406698|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406699|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406700|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406701|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406702|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406703|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406704|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406705|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406706|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406707|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406708|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406709|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406710|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406711|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406712|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406713|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406714|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406715|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406716|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406717|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406718|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406719|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406720|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406721|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406722|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406723|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406724|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406725|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406726|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406727|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406728|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406729|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406730|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406731|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406732|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406733|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406734|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406735|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406736|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406737|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406738|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406739|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406740|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406741|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406742|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406743|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406744|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406745|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406746|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406747|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406748|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406749|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406750|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406751|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406752|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406753|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406754|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406755|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406756|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406757|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406758|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406759|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406760|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406761|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406762|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406763|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406764|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406765|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406766|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406767|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406768|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406769|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406770|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406771|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406772|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406773|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406774|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406775|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406776|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406777|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406778|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406779|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406780|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406781|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406782|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406783|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406784|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406785|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406786|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406787|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406788|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406789|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406790|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406791|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406792|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406793|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406794|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406795|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406796|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406797|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406798|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406799|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406800|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406801|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406802|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406803|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406804|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406805|NCT00502593|E12|Reported Event|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406806|NCT00502593|E11|Reported Event|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406807|NCT00502593|E10|Reported Event|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406808|NCT00502593|E9|Reported Event|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406809|NCT00502593|E8|Reported Event|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406810|NCT00502593|E7|Reported Event|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406811|NCT00502593|E6|Reported Event|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406812|NCT00502593|E5|Reported Event|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406813|NCT00502593|E4|Reported Event|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406814|NCT00502593|E3|Reported Event|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406815|NCT00502593|E2|Reported Event|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406816|NCT00502593|E1|Reported Event|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
406817|NCT00503399|B3|Baseline|Total|Total of all reporting groups
406818|NCT00503399|B2|Baseline|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406819|NCT00503399|B1|Baseline|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406820|NCT00503399|P2|Participant Flow|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406821|NCT00503399|P1|Participant Flow|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406822|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406823|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406824|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406825|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406826|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406827|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406828|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406829|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406830|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406831|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406832|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406833|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406834|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406835|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406836|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406837|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406838|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406839|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406840|NCT00503399|E2|Reported Event|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
406841|NCT00503399|E1|Reported Event|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
406842|NCT00503425|B1|Baseline|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
406843|NCT00503425|P1|Participant Flow|Rituximab|Participants received rituximab (MabThera) 1000 milligrams (mg) intravenous (IV) dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the European League Against Rheumatism (EULAR) response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
406844|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
407159|NCT00504881|B1|Baseline|Placebo|Matching Placebo tablets administered twice a day
406846|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
406847|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
406848|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
406849|NCT00503425|E1|Reported Event|Rituximab|Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
406850|NCT00503698|B3|Baseline|Total|Total of all reporting groups
406851|NCT00503698|B2|Baseline|Placebo|Placebo once daily, week 0 to end of trial
406852|NCT00503698|B1|Baseline|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
406853|NCT00503698|P2|Participant Flow|Placebo|Placebo once daily, week 0 to end of trial
406854|NCT00503698|P1|Participant Flow|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
406855|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
406856|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
406857|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
406858|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
406859|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
406860|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
406861|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
406862|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
406863|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
406864|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
406865|NCT00503698|E2|Reported Event|Placebo|Placebo once daily, week 0 to end of trial
406866|NCT00503698|E1|Reported Event|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
406867|NCT00503750|B1|Baseline|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
406868|NCT00503750|P1|Participant Flow|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
406869|NCT00503750|O1|Outcome|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
406870|NCT00503750|O1|Outcome|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
406902|NCT00503776|E3|Reported Event|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
406903|NCT00503776|E2|Reported Event|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
425895|NCT00542425|O2|Outcome|BA058 20 µg|
406871|NCT00503750|E1|Reported Event|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
406872|NCT00503776|B5|Baseline|Total|Total of all reporting groups
406873|NCT00503776|B4|Baseline|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
406874|NCT00503776|B3|Baseline|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
406875|NCT00503776|B2|Baseline|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
406876|NCT00503776|B1|Baseline|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
406877|NCT00503776|P4|Participant Flow|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
406878|NCT00503776|P3|Participant Flow|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
406879|NCT00503776|P2|Participant Flow|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
406880|NCT00503776|P1|Participant Flow|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
406881|NCT00503776|O4|Outcome|Arm IIB|"Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
exercise intervention: Patients undergo low weight resistance training.
amifostine trihydrate: Given subcutaneously
therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
406882|NCT00503776|O3|Outcome|Arm IIA|"Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
amifostine trihydrate: Given subcutaneously
therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
406883|NCT00503776|O2|Outcome|Arm IB|"Patients undergo SNT and low weight resistance training (LWRT).
exercise intervention: Patients undergo low weight resistance training.
therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
406884|NCT00503776|O1|Outcome|Arm IA|"Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
406885|NCT00503776|O4|Outcome|Arm IIB|"Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
exercise intervention: Patients undergo low weight resistance training.
amifostine trihydrate: Given subcutaneously
therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
406886|NCT00503776|O3|Outcome|Arm IIA|"Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
amifostine trihydrate: Given subcutaneously
therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
406887|NCT00503776|O2|Outcome|Arm IB|"Patients undergo SNT and low weight resistance training (LWRT).
exercise intervention: Patients undergo low weight resistance training.
therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
406888|NCT00503776|O1|Outcome|Arm IA|"Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
406889|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
406890|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
406891|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
406892|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
406893|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
406894|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
406895|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
406896|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
406897|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
406898|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
406899|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low-weight resistance training (LWRT).
406900|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
407029|NCT00504426|E3|Reported Event|OPC-249 (60IU)|60 IU of OPC-249/vial
406905|NCT00503841|B1|Baseline|Erlotinib Hydrochloride|If participants would have went onto study they would receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.
406906|NCT00503841|P1|Participant Flow|Erlotinib Hydrochloride|"If participants would have went onto study they would receive erlotinib(Tarceva®)hydrochloride 150 mg/day starting dose PO (orally) self-administered, QD (every day) on days -14 until day 0 immediately prior to scheduled surgery, Tissue sent for biomarker modulation analysis
Treatment continues in the absence of disease progression or unacceptable toxicity.
Biomarker analysis performed, toxicity monitored for 7 days following last dose of erlotinib (Tarceva®)"
406907|NCT00503841|O1|Outcome|Erlotinib Hydrochloride|Patients must be willing to consider treatment with erlotinib, in the event they are eligible for the treatment phase of the study. Erlotinib (Tarceva®) will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single-agent erlotinib (Tarceva®), at a dose of 150 mg/day mg by mouth. Patients will be instructed to take tablets once daily. The day of planned surgical resection of the invasive breast cancer will be considered day 0. Patients will undergo baseline physical examination and performance status evaluation on or before day -14. Patients will begin treatment with erlotinib 150 mg (1 tablet) orally daily on day -14 and it will be continued for a total of 15 days, through day 0.
406908|NCT00503841|E1|Reported Event|Erlotinib Hydrochloride|Patients will be instructed to take tablets once daily.Patients will begin treatment with erlotinib 150 mg (1 tablet) orally daily on day -14 and it will be continued for a total of 15 days, through day 0.The day of planned surgical resection of the invasive breast cancer will be considered day 0.
406909|NCT00503906|B1|Baseline|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:
Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
406910|NCT00503906|P1|Participant Flow|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:
Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
406911|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:
Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
406912|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:
Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
Avastin
Gemcitabine
Abraxane"
406913|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:
Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
406914|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:
Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
406915|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:
Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
406916|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:
Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
406917|NCT00503906|E1|Reported Event|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:
Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
406918|NCT00503984|B3|Baseline|Total|Total of all reporting groups
406919|NCT00503984|B2|Baseline|Phase 2|All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
406920|NCT00503984|B1|Baseline|Phase 1|"All Phase 1 participants who received at least one dose of the combination of Azacitidine (Aza) and Docetaxel (Doc) and 5mg of Prednisone at one of the starting dose levels:
Level 1: 75 mg/m2 Aza + 60 mg/m2 Doc
Level 2: 75 mg/m2 Aza + 75 mg/m2 Doc
Level 3: 100 mg/m2 Aza + 75 mg/m2 Doc
Level 4: 150 mg/m2 Aza + 75 mg/m2 Doc"
406921|NCT00503984|P6|Participant Flow|Phase 2 - Aza + Doc Reduced RPTD|All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
406922|NCT00503984|P5|Participant Flow|Phase 2 - Aza + Doc Initial RPTD|All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
425896|NCT00542425|O1|Outcome|Placebo|
406990|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
406923|NCT00503984|P4|Participant Flow|Phase 1: Level 4 - 150 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 4 dose combination of 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5 mg of Prednisone.
406924|NCT00503984|P3|Participant Flow|Phase 1: Level 3 - 100 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 3 dose combination of 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
406925|NCT00503984|P2|Participant Flow|Phase 1: Level 2 - 75 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 2 dose combination of 75 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
406926|NCT00503984|P1|Participant Flow|Phase 1: Level 1 - 75 Aza + 60 Doc|All Phase 1 participants who received at least one dose starting at the Level 1 dose combination of 75 mg/m^2 of Azacitidine (Aza), 60 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
406927|NCT00503984|O4|Outcome|Level 4 - 150 Aza + 75 Doc|150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
406928|NCT00503984|O3|Outcome|Level 3 - 100 Aza + 75 Doc|100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
406929|NCT00503984|O2|Outcome|Level 2 - 75 Aza + 75 Doc|75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
406930|NCT00503984|O1|Outcome|Level 1 - 75 Aza + 60 Doc|75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
406931|NCT00503984|O1|Outcome|All Study Participants|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.
406932|NCT00503984|O1|Outcome|All Study Participants|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.
406933|NCT00503984|O1|Outcome|All Study Participants Achieving PSA Response|All study participants who achieved PSA response to protocol therapy. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.
406934|NCT00503984|O5|Outcome|Phase 2 - Aza + Doc Initial RPTD|Initial Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
406935|NCT00503984|O4|Outcome|Phase 1: Level 4 - 150 Aza + 75 Doc|Phase 1, Starting Dose Level 4: 150 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
406936|NCT00503984|O3|Outcome|Phase 1: Level 3 - 100 Aza + 75 Doc|Phase 1, Starting Dose Level 3: 100 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
406937|NCT00503984|O2|Outcome|Phase 1: Level 2 - 75 Aza + 75 Doc|Phase 1, Starting Dose Level 2: 75 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
406938|NCT00503984|O1|Outcome|Phase 1: Level 1 - 75 Aza + 60 Doc|Phase 1, Starting Dose Level 1: 75 mg/m2 of Azacitidine (Aza), 60 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
406939|NCT00503984|O6|Outcome|Phase 2 - Aza + Doc Reduced RPTD|All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
406940|NCT00503984|O5|Outcome|Phase 2 - Aza + Doc Initial RPTD|Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
406941|NCT00503984|O4|Outcome|Phase 1: Level 4 - 150 Aza + 75 Doc|Phase 1, Starting Dose Level 1: 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
406942|NCT00503984|O3|Outcome|Phase 1: Level 3 - 100 Aza + 75 Doc|Phase 1, Starting Dose Level 3: 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
406943|NCT00503984|O2|Outcome|Phase 1: Level 2 - 75 Aza + 75 Doc|Phase 1, Starting Dose Level 2: 75 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
406944|NCT00503984|O1|Outcome|Phase 1: Level 1 - 75 Aza + 60 Doc|Phase 1, Starting Dose Level 1: 75 mg/m^2 of Azacitidine (Aza), 60 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
406945|NCT00503984|O1|Outcome|Phase 1 - Aza + Doc|Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).
406946|NCT00503984|O1|Outcome|Phase 1 - Aza + Doc|Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).
406947|NCT00503984|E4|Reported Event|Level 4 - 150 Aza + 75 Doc|150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
406948|NCT00503984|E3|Reported Event|Level 3 - 100 Aza + 75 Doc|100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
406949|NCT00503984|E2|Reported Event|Level 2 - 75 Aza + 75 Doc|75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
406950|NCT00503984|E1|Reported Event|Level 1 - 75 Aza + 60 Doc|75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
406951|NCT00503997|B1|Baseline|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
406952|NCT00503997|P1|Participant Flow|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
406953|NCT00503997|O1|Outcome|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
406954|NCT00503997|E1|Reported Event|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
406955|NCT00504075|B1|Baseline|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
406956|NCT00504075|P1|Participant Flow|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
406957|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
406958|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of Gammaplex was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
406959|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
406960|NCT00504075|E1|Reported Event|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
406961|NCT00504153|B1|Baseline|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
406962|NCT00504153|P1|Participant Flow|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
406963|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
406964|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
406965|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
406966|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
406967|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
406968|NCT00504153|E1|Reported Event|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
406969|NCT00504166|B3|Baseline|Total|Total of all reporting groups
406970|NCT00504166|B2|Baseline|Placebo|placebo to match alendronate sodium
406971|NCT00504166|B1|Baseline|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
406972|NCT00504166|P2|Participant Flow|Placebo|placebo to match alendronate sodium
406973|NCT00504166|P1|Participant Flow|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
406974|NCT00504166|O2|Outcome|Placebo Treatment|daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
406975|NCT00504166|O1|Outcome|Alendronate Treatment|70 mg of alendronate once weekly and daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
406976|NCT00504166|E2|Reported Event|Placebo|placebo to match alendronate sodium
406977|NCT00504166|E1|Reported Event|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
406978|NCT00504231|B5|Baseline|Total|Total of all reporting groups
406979|NCT00504231|B4|Baseline|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
406980|NCT00504231|B3|Baseline|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
406981|NCT00504231|B2|Baseline|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
406982|NCT00504231|B1|Baseline|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
406983|NCT00504231|P4|Participant Flow|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
406984|NCT00504231|P3|Participant Flow|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
406985|NCT00504231|P2|Participant Flow|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
406986|NCT00504231|P1|Participant Flow|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
406987|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
406988|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
406989|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
406991|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|60% dose - 0.15 mL delivered twice intradermally with needle and syringe
406992|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|60% dose - 0.3 mL delivered intradermally with needle and syringe
406993|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|60% dose - 0.3 mL delivered intramuscularly with needle and syringe
406994|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|100% dose - 0.5mL delivered intramuscularly with needle and syringe
406995|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|60% dose - 0.15 mL delivered twice intradermally with needle and syringe
406996|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|60% dose - 0.3 mL delivered intradermally with needle and syringe
406997|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|60% dose - 0.3 mL delivered intramuscularly with needle and syringe
406998|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|100% dose - 0.5mL delivered intramuscularly with needle and syringe
406999|NCT00504231|E4|Reported Event|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
407000|NCT00504231|E3|Reported Event|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
407001|NCT00504231|E2|Reported Event|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
407002|NCT00504231|E1|Reported Event|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
407003|NCT00504257|B1|Baseline|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
407004|NCT00504257|P1|Participant Flow|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
407005|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
407006|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
407007|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
407008|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
407009|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
407010|NCT00504257|E1|Reported Event|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
407011|NCT00504426|B5|Baseline|Total|Total of all reporting groups
407012|NCT00504426|B4|Baseline|OPC-249 (120IU)|120 IU of OPC-249/vial
407013|NCT00504426|B3|Baseline|OPC-249 (60IU)|60 IU of OPC-249/vial
407014|NCT00504426|B2|Baseline|OPC-249 (30IU)|30 IU of OPC-249/vial
407015|NCT00504426|B1|Baseline|Placebo|Placebo of OPC-249/vial
407016|NCT00504426|P4|Participant Flow|OPC-249 (120IU)|120 IU of OPC-249/vial
407017|NCT00504426|P3|Participant Flow|OPC-249 (60IU)|60 IU of OPC-249/vial
407018|NCT00504426|P2|Participant Flow|OPC-249 (30IU)|30 IU of OPC-249/vial
407019|NCT00504426|P1|Participant Flow|Placebo|Placebo of OPC-249/vial
407020|NCT00504426|O4|Outcome|OPC-249 (120IU)|120 IU of OPC-249/vial
407021|NCT00504426|O3|Outcome|OPC-249 (60IU)|60 IU of OPC-249/vial
407022|NCT00504426|O2|Outcome|OPC-249 (30IU)|30 IU of OPC-249/vial
407023|NCT00504426|O1|Outcome|Placebo|Placebo of OPC-249/vial
407024|NCT00504426|O4|Outcome|OPC-249 (120IU)|120 IU of OPC-249 /vial
407025|NCT00504426|O3|Outcome|OPC-249 (60IU)|60 IU of OPC-249 /vial
407026|NCT00504426|O2|Outcome|OPC-249 (30IU)|30 IU of OPC-249 /vial
407027|NCT00504426|O1|Outcome|Placebo|Placebo of OPC-249/vial
407028|NCT00504426|E4|Reported Event|OPC-249 (120IU)|120 IU of OPC-249/vial
407081|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407032|NCT00504504|B1|Baseline|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
407033|NCT00504504|P1|Participant Flow|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
407034|NCT00504504|O1|Outcome|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
407035|NCT00504504|E1|Reported Event|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
407036|NCT00504556|B6|Baseline|Total|Total of all reporting groups
407037|NCT00504556|B5|Baseline|Warfarin Tablets|"warfarin tablets
warfarin: warfarin tablets"
407038|NCT00504556|B4|Baseline|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407039|NCT00504556|B3|Baseline|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407040|NCT00504556|B2|Baseline|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407041|NCT00504556|B1|Baseline|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407042|NCT00504556|P5|Participant Flow|Warfarin Tablets|"warfarin tablets
warfarin: warfarin tablets"
407043|NCT00504556|P4|Participant Flow|DU-176b 60mg Bid|"DU-176b 60mg tablets two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407044|NCT00504556|P3|Participant Flow|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407045|NCT00504556|P2|Participant Flow|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407046|NCT00504556|P1|Participant Flow|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407047|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407048|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407049|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407050|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407051|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407052|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407053|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407054|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407055|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407056|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407057|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407058|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407059|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407060|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407061|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407062|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407063|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407064|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407065|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407066|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407067|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407068|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407069|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407070|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407071|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets
warfarin: warfarin tablets"
407072|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407073|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407074|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407075|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407076|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407077|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407078|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407079|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407080|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets
warfarin: warfarin tablets"
407082|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407083|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407084|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407085|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets
warfarin: warfarin tablets"
407086|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407087|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407088|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407089|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407090|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets
warfarin: warfarin tablets"
407091|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407092|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407093|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407094|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407095|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets
warfarin: warfarin tablets"
407096|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407097|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407098|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407099|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407100|NCT00504556|E5|Reported Event|Warfarin Tablets|"warfarin tablets
warfarin: warfarin tablets"
407101|NCT00504556|E4|Reported Event|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day
Edoxaban (DU-176b): 60mg tablet two times a day"
407102|NCT00504556|E3|Reported Event|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)
Edoxaban (DU-176b): 60mg tablet once daily"
407103|NCT00504556|E2|Reported Event|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)
Edoxaban (DU-176b): 30mg tablet twice daily"
407104|NCT00504556|E1|Reported Event|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)
Edoxaban (DU-176b): 30mg tablet once daily"
407105|NCT00504595|B5|Baseline|Total|Total of all reporting groups
407106|NCT00504595|B4|Baseline|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
407107|NCT00504595|B3|Baseline|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
407108|NCT00504595|B2|Baseline|ACZ885 (Canakinumab) : Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1
407109|NCT00504595|B1|Baseline|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
407110|NCT00504595|P4|Participant Flow|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
407111|NCT00504595|P3|Participant Flow|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
407112|NCT00504595|P2|Participant Flow|ACZ885 (Canakinumab) : Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1
407113|NCT00504595|P1|Participant Flow|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
407114|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
407115|NCT00504595|O1|Outcome|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
407116|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Patients with Rheumatoid Arthritis (RA) who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
407117|NCT00504595|O1|Outcome|ACZ885 (Canakinumab): RA Patients|Patients with Rheumatoid Arthritis (RA) taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
407118|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
407119|NCT00504595|O1|Outcome|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
407120|NCT00504595|E4|Reported Event|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
407121|NCT00504595|E3|Reported Event|ACZ885 (Canakinumab): RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
407122|NCT00504595|E2|Reported Event|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
407123|NCT00504595|E1|Reported Event|ACZ885 (Canakinumab): Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1.
407124|NCT00504660|B3|Baseline|Total|Total of all reporting groups
407125|NCT00504660|B2|Baseline|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.
Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
407158|NCT00504881|B2|Baseline|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407300|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407126|NCT00504660|B1|Baseline|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
407127|NCT00504660|P2|Participant Flow|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.
Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
407128|NCT00504660|P1|Participant Flow|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
407129|NCT00504660|O1|Outcome|Participants With Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.
Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
407130|NCT00504660|O1|Outcome|Participants With Recurrent Anaplastic Glioma|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Capecitabine 825 mg/m^2 and Celebrex 400 mg PO every 12 hours; Arm 1 Temozolomide (TMZ) 150 mg/m^2 PO daily Days 4-8 OR Arm 2 Lomustine 100 mg/m^2 PO on Day 4; Arm 2 Participants if previously received Temozolomide but not Lomustine (CCNU) receive Lomustine; or if had Gliadel wafers and Temozolomide with radiotherapy (XRT) receive Temozolomide.
407131|NCT00504660|E2|Reported Event|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.
Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
407132|NCT00504660|E1|Reported Event|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
407133|NCT00504725|B3|Baseline|Total|Total of all reporting groups
407134|NCT00504725|B2|Baseline|Placebo|0.9 % saline bolus of equivalent volume
407135|NCT00504725|B1|Baseline|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
407136|NCT00504725|P2|Participant Flow|Placebo|0.9 % saline bolus of equivalent volume
407137|NCT00504725|P1|Participant Flow|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
407138|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
407139|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
407140|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
407141|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
407142|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
407143|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
407144|NCT00504725|E2|Reported Event|Placebo|0.9 % saline bolus of equivalent volume
407145|NCT00504725|E1|Reported Event|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
407146|NCT00504751|B1|Baseline|Study Treatment|This is a single arm study
407147|NCT00504751|P1|Participant Flow|Study Treatment|"This is a single arm study
bortezomib, dexamethasone, ifosfamide: VIPER chemotherapy will be administered every 28 days at the following doses:
Dexamethasone 40 mg IV days 1-4
Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
Cisplatin 25 mg IV days 1-4
Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
VELCADE 1.5 mg/m2 on days 2 and 5
mesna, cisplatin, etoposide, rituximab: VIPER chemotherapy will be administered every 28 days at the following doses:
Dexamethasone 40 mg IV days 1-4
Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
Cisplatin 25 mg IV days 1-4
Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
VELCADE 1.5"
407148|NCT00504751|O1|Outcome|Study Treatment|This is a single arm study
407149|NCT00504751|E1|Reported Event|Study Treatment|This is a single arm study
407150|NCT00504777|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV, and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
407151|NCT00504777|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
407152|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
407153|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
407154|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
407155|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
407156|NCT00504777|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
407157|NCT00504881|B3|Baseline|Total Title|
407160|NCT00504881|P2|Participant Flow|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407161|NCT00504881|P1|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
407162|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407163|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407164|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407165|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407166|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407167|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407168|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407169|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407170|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407171|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407172|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407173|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407174|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407175|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407176|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407177|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407178|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407179|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407180|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407181|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407182|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407183|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407184|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407185|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407186|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407187|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407188|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407189|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407190|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407191|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407192|NCT00504881|O2|Outcome|Brivaracetam|"A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Brivaracetam: Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period"
407193|NCT00504881|O1|Outcome|Placebo|"Matching Placebo tablets administered twice a day
Placebo: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period"
407194|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407195|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407196|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407197|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407198|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407199|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407200|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407201|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407202|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407203|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407204|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407205|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407206|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407207|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
407208|NCT00504881|E2|Reported Event|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
407209|NCT00504881|E1|Reported Event|Placebo|Matching Placebo tablets administered twice a day
407210|NCT00504894|B3|Baseline|Total|Total of all reporting groups
407211|NCT00504894|B2|Baseline|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.
Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
407212|NCT00504894|B1|Baseline|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.
Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
407213|NCT00504894|P2|Participant Flow|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.
Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
407214|NCT00504894|P1|Participant Flow|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.
Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
407215|NCT00504894|O2|Outcome|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.
Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
407216|NCT00504894|O1|Outcome|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.
Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
407217|NCT00504894|E2|Reported Event|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.
Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
407218|NCT00504894|E1|Reported Event|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.
Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
407219|NCT00504985|B1|Baseline|Fatigue in Emergency Center Patients|
407220|NCT00504985|P1|Participant Flow|Fatigue in Emergency Center Patients|
407221|NCT00504985|O1|Outcome|Fatigue in Emergency Center Patients|
407222|NCT00504985|E1|Reported Event|Fatigue in Emergency Center Patients|
407223|NCT00505076|B4|Baseline|Total|Total of all reporting groups
407224|NCT00505076|B3|Baseline|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
407225|NCT00505076|B2|Baseline|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
407226|NCT00505076|B1|Baseline|MK-077 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
407227|NCT00505076|P3|Participant Flow|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
407228|NCT00505076|P2|Participant Flow|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
407229|NCT00505076|P1|Participant Flow|MK-0777 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
407230|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
407231|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
407232|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
407233|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
407234|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
407235|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
407236|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
407237|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
407238|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
407239|NCT00505076|E3|Reported Event|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
407240|NCT00505076|E2|Reported Event|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
407241|NCT00505076|E1|Reported Event|MK-077 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
407242|NCT00505284|B6|Baseline|Total|Total of all reporting groups
407243|NCT00505284|B5|Baseline|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407244|NCT00505284|B4|Baseline|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407245|NCT00505284|B3|Baseline|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407246|NCT00505284|B2|Baseline|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407247|NCT00505284|B1|Baseline|Placebo|
407248|NCT00505284|P5|Participant Flow|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407249|NCT00505284|P4|Participant Flow|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407250|NCT00505284|P3|Participant Flow|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407251|NCT00505284|P2|Participant Flow|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407252|NCT00505284|P1|Participant Flow|Placebo|
407253|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407254|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407255|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407256|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407257|NCT00505284|O1|Outcome|Placebo|
407258|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407259|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407260|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407261|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407262|NCT00505284|O1|Outcome|Placebo|
407263|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407264|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407265|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407266|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407267|NCT00505284|O1|Outcome|Placebo|
407268|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407269|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407270|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407271|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407272|NCT00505284|O1|Outcome|Placebo|
407273|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407274|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407275|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407276|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407277|NCT00505284|O1|Outcome|Placebo|
407278|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407279|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407280|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407281|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407282|NCT00505284|O1|Outcome|Placebo|
407283|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407284|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407285|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407286|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407287|NCT00505284|O1|Outcome|Placebo|
407288|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407289|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407290|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407291|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407292|NCT00505284|O1|Outcome|Placebo|
407293|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407294|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407295|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407296|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407297|NCT00505284|O1|Outcome|Placebo|
407298|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407299|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407505|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407303|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407304|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407305|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407306|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407307|NCT00505284|O1|Outcome|Placebo|
407308|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407309|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407310|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407311|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407312|NCT00505284|O1|Outcome|Placebo|
407313|NCT00505284|E5|Reported Event|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
407314|NCT00505284|E4|Reported Event|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
407315|NCT00505284|E3|Reported Event|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
407316|NCT00505284|E2|Reported Event|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
407317|NCT00505284|E1|Reported Event|Placebo|
407318|NCT00505362|B3|Baseline|Total|Total of all reporting groups
407319|NCT00505362|B2|Baseline|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
407320|NCT00505362|B1|Baseline|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.
Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
407321|NCT00505362|P2|Participant Flow|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
407322|NCT00505362|P1|Participant Flow|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.
Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
407323|NCT00505362|O2|Outcome|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
407324|NCT00505362|O1|Outcome|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.
Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
407325|NCT00505362|O2|Outcome|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
407326|NCT00505362|O1|Outcome|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.
Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
407327|NCT00505362|E2|Reported Event|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
407328|NCT00505362|E1|Reported Event|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.
Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
407329|NCT00505375|B3|Baseline|Total|Total of all reporting groups
407330|NCT00505375|B2|Baseline|Placebo|"Intravenous infusions of placebo
Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
407331|NCT00505375|B1|Baseline|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig
CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
407332|NCT00505375|P2|Participant Flow|Placebo|"Intravenous infusions of placebo
Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
407333|NCT00505375|P1|Participant Flow|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig
CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
407334|NCT00505375|O2|Outcome|Placebo|Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses
407335|NCT00505375|O1|Outcome|CTLA-4 Ig|Intravenous infusions 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses
407336|NCT00505375|E2|Reported Event|Placebo|"Intravenous infusions of placebo
Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
407337|NCT00505375|E1|Reported Event|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig
CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
407338|NCT00505414|B3|Baseline|Total|Total of all reporting groups
407339|NCT00505414|B2|Baseline|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
407506|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407340|NCT00505414|B1|Baseline|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
407341|NCT00505414|P5|Participant Flow|Morphine (Titration Phase)|After signing informed consent eligible participants were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
407342|NCT00505414|P4|Participant Flow|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg up to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
407343|NCT00505414|P3|Participant Flow|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
407344|NCT00505414|P2|Participant Flow|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
407345|NCT00505414|P1|Participant Flow|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
407346|NCT00505414|O5|Outcome|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
407347|NCT00505414|O4|Outcome|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
407348|NCT00505414|O3|Outcome|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
407349|NCT00505414|O2|Outcome|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
407350|NCT00505414|O1|Outcome|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
407351|NCT00505414|O3|Outcome|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
407352|NCT00505414|O2|Outcome|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
407353|NCT00505414|O1|Outcome|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
407354|NCT00505414|E5|Reported Event|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
407355|NCT00505414|E4|Reported Event|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
407356|NCT00505414|E3|Reported Event|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
407357|NCT00505414|E2|Reported Event|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
407358|NCT00505414|E1|Reported Event|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
407359|NCT00505518|B1|Baseline|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
407360|NCT00505518|P1|Participant Flow|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
407361|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
407362|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
407363|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
407364|NCT00505518|E1|Reported Event|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
407365|NCT00505622|B4|Baseline|Total|Total of all reporting groups
407429|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)
Data were combined across placebo conditions for analysis"
456454|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
407366|NCT00505622|B3|Baseline|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407367|NCT00505622|B2|Baseline|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407368|NCT00505622|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407369|NCT00505622|P3|Participant Flow|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407370|NCT00505622|P2|Participant Flow|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407371|NCT00505622|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407372|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407373|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407374|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407375|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407376|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407377|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407378|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407379|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407507|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407380|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407381|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407382|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407383|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407384|NCT00505622|E3|Reported Event|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407385|NCT00505622|E2|Reported Event|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407386|NCT00505622|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
407387|NCT00505635|B1|Baseline|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
407388|NCT00505635|P1|Participant Flow|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
407389|NCT00505635|O1|Outcome|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
407390|NCT00505635|E1|Reported Event|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
407391|NCT00505661|B1|Baseline|Letrozole|2.5 mg by mouth (PO) daily
407392|NCT00505661|P1|Participant Flow|Letrozole|2.5 mg by mouth (PO) daily
407393|NCT00505661|O1|Outcome|Letrozole|2.5 mg by mouth (PO) daily
407394|NCT00505661|E1|Reported Event|Letrozole|2.5 mg by mouth (PO) daily
407395|NCT00505687|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
407396|NCT00505687|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
407397|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
407398|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
407399|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
407400|NCT00505687|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
407401|NCT00505752|B5|Baseline|Total|Total of all reporting groups
407402|NCT00505752|B4|Baseline|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407426|NCT00505765|P3|Participant Flow|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)
Data were combined across placebo conditions for analysis"
425897|NCT00542425|O5|Outcome|Teriparatide|
407403|NCT00505752|B3|Baseline|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407404|NCT00505752|B2|Baseline|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407405|NCT00505752|B1|Baseline|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407406|NCT00505752|P4|Participant Flow|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407407|NCT00505752|P3|Participant Flow|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407408|NCT00505752|P2|Participant Flow|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407409|NCT00505752|P1|Participant Flow|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407410|NCT00505752|O4|Outcome|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407411|NCT00505752|O3|Outcome|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407412|NCT00505752|O2|Outcome|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407427|NCT00505765|P2|Participant Flow|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
407428|NCT00505765|P1|Participant Flow|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
407413|NCT00505752|O1|Outcome|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407414|NCT00505752|O4|Outcome|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407415|NCT00505752|O3|Outcome|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407416|NCT00505752|O2|Outcome|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407417|NCT00505752|O1|Outcome|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407418|NCT00505752|E4|Reported Event|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407419|NCT00505752|E3|Reported Event|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407420|NCT00505752|E2|Reported Event|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407421|NCT00505752|E1|Reported Event|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
407422|NCT00505765|B4|Baseline|Total|Total of all reporting groups
407423|NCT00505765|B3|Baseline|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)
Data were combined across placebo conditions for analysis"
407424|NCT00505765|B2|Baseline|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
407425|NCT00505765|B1|Baseline|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
407503|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407431|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
407432|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)
Data were combined across placebo conditions for analysis"
407433|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
407434|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
407435|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)
Data were combined across placebo conditions for analysis"
407436|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
407437|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
407438|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)
Data were combined across placebo conditions for analysis"
407439|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
407440|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
407441|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)
Data were combined across placebo conditions for analysis"
407442|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
407443|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
407444|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)
Data were combined across placebo conditions for analysis"
407445|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
407446|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
407447|NCT00505765|E3|Reported Event|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)
Data were combined across placebo conditions for analysis"
407448|NCT00505765|E2|Reported Event|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
407449|NCT00505765|E1|Reported Event|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
407450|NCT00505778|B3|Baseline|Total|Total of all reporting groups
407451|NCT00505778|B2|Baseline|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
407452|NCT00505778|B1|Baseline|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
407453|NCT00505778|P2|Participant Flow|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
407454|NCT00505778|P1|Participant Flow|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
407455|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
407456|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
407457|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
407458|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
407459|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
407460|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
407461|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
407462|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
407463|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
407464|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
407465|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
407466|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
407467|NCT00505778|E2|Reported Event|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
407468|NCT00505778|E1|Reported Event|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
407469|NCT00505895|B3|Baseline|Total|Total of all reporting groups
407470|NCT00505895|B2|Baseline|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4).
Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5."
407471|NCT00505895|B1|Baseline|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).
Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
407472|NCT00505895|P2|Participant Flow|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).
Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
407473|NCT00505895|P1|Participant Flow|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).
Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
407504|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
407474|NCT00505895|O2|Outcome|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).
Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
410701|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
407475|NCT00505895|O1|Outcome|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).
Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
407476|NCT00505895|O2|Outcome|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).
Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
407477|NCT00505895|O1|Outcome|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).
Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
407478|NCT00505895|E2|Reported Event|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).
Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
407479|NCT00505895|E1|Reported Event|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).
Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
407480|NCT00505921|B1|Baseline|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.
Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)
Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
407481|NCT00505921|P1|Participant Flow|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.
Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)
Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
407482|NCT00505921|O1|Outcome|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.
Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)
Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
407483|NCT00505921|E1|Reported Event|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.
Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)
Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
407484|NCT00497770|B5|Baseline|Total|Total of all reporting groups
407485|NCT00497770|B4|Baseline|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407486|NCT00497770|B3|Baseline|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407487|NCT00497770|B2|Baseline|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407488|NCT00497770|B1|Baseline|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
407489|NCT00497770|P4|Participant Flow|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407490|NCT00497770|P3|Participant Flow|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407491|NCT00497770|P2|Participant Flow|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407492|NCT00497770|P1|Participant Flow|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
407493|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407494|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407495|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407496|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
407497|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407498|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407499|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407500|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
407501|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407502|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407508|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
407509|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407510|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407511|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407512|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
407513|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407514|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407515|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407516|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
407517|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407518|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407519|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407520|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
407521|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407522|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407523|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407524|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
407525|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407526|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407527|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407528|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
407529|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407530|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407531|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407532|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
407533|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407534|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407535|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407536|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
407537|NCT00497770|E4|Reported Event|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
407538|NCT00497770|E3|Reported Event|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
407539|NCT00497770|E2|Reported Event|African American|African American participants receiving pemetrexed for 2nd line NSCLC
407540|NCT00497770|E1|Reported Event|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
407541|NCT00497796|B3|Baseline|Total|Total of all reporting groups
407542|NCT00497796|B2|Baseline|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407543|NCT00497796|B1|Baseline|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407544|NCT00497796|P2|Participant Flow|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407545|NCT00497796|P1|Participant Flow|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407546|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407547|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407548|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407549|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407550|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407551|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407552|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407553|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407554|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407555|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407556|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407557|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407558|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407559|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407560|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407561|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407562|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407563|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407564|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407565|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407566|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407567|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407568|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407569|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407570|NCT00497796|E2|Reported Event|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
407571|NCT00497796|E1|Reported Event|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
407572|NCT00497874|B3|Baseline|Total|Total of all reporting groups
407573|NCT00497874|B2|Baseline|Usual Care|Usual primary care treatment
407574|NCT00497874|B1|Baseline|Intervention|Stage-based manual and three computer-tailored reports
407575|NCT00497874|P2|Participant Flow|Usual Care|Usual primary care treatment
407576|NCT00497874|P1|Participant Flow|Intervention|Stage-based manual and three computer-tailored reports
407577|NCT00497874|O2|Outcome|Usual Care|Usual primary care
407578|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
407579|NCT00497874|O2|Outcome|Usual Care|Usual primary care
407580|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
407581|NCT00497874|O2|Outcome|Usual Care|Usual primary care
407582|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
407583|NCT00497874|O2|Outcome|Usual Care|Usual primary care
407584|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
407585|NCT00497874|O2|Outcome|Usual Care|Usual primary care treatment
407586|NCT00497874|O1|Outcome|Intervention|Stage-based manual and three computer-tailored reports
407587|NCT00497874|O2|Outcome|Usual Care|Usual primary care
407588|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
407589|NCT00497874|E2|Reported Event|Usual Care|Usual primary care treatment
407590|NCT00497874|E1|Reported Event|Intervention|Stage-based manual and three computer-tailored reports
407591|NCT00498173|B3|Baseline|Total|Total of all reporting groups
407592|NCT00498173|B2|Baseline|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
407593|NCT00498173|B1|Baseline|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
407594|NCT00498173|P3|Participant Flow|Atomoxetine (Open Label Trial)|Placebo-treated subjects from the randomized trial that don't respond to placebo will be offered an 8-week open-label trial of atomoxetine.
407595|NCT00498173|P2|Participant Flow|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
407596|NCT00498173|P1|Participant Flow|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
407597|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
407598|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
407599|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
407600|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
407601|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
407602|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
407603|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
407604|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
407605|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
407606|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
407629|NCT00498355|P1|Participant Flow|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
407630|NCT00498355|O1|Outcome|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
408568|NCT00508001|P2|Participant Flow|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
407607|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
407608|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
407609|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
407610|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
407611|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
407612|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
407613|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
407614|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
407615|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
407616|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
407617|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
407618|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
407619|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
407620|NCT00498173|E3|Reported Event|Atomoxetine (Open Label Trial)|Placebo-treated subjects from the randomized trial that don’t respond to placebo will be offered an 8-week open-label trial of atomoxetine
407621|NCT00498173|E2|Reported Event|Placebo (Randomized)|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
407622|NCT00498173|E1|Reported Event|Atomoxetine (Randomized)|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.
Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
407623|NCT00498186|B1|Baseline|Rotigotine|Rotigotine trans-dermal patch
407624|NCT00498186|P1|Participant Flow|Rotigotine|Rotigotine trans-dermal patch
407625|NCT00498186|O1|Outcome|Rotigotine|Rotigotine trans-dermal patch
407626|NCT00498186|O1|Outcome|Rotigotine|Rotigotine trans-dermal patch
407627|NCT00498186|E1|Reported Event|Rotigotine|Rotigotine trans-dermal patch
407628|NCT00498355|B1|Baseline|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
425898|NCT00542425|O4|Outcome|BA058 80 µg|
407631|NCT00498355|E1|Reported Event|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
407632|NCT00498368|B3|Baseline|Total|Total of all reporting groups
407633|NCT00498368|B2|Baseline|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement
ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg)
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407634|NCT00498368|B1|Baseline|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement
Intravenous Rituximab: Rituximab Therapy [27 Patients]
Rituximab 1 gm IV on Treatment Day 1
Rituximab 1 gm IV on Treatment Day 15
Rituximab 1 gm IV on Treatment Day 168
Rituximab 1 gm IV on Treatment Day 182
An ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg)
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407635|NCT00498368|P2|Participant Flow|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement
ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407636|NCT00498368|P1|Participant Flow|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement
Intravenous Rituximab: Rituximab Therapy [27 Patients]
Rituximab 1 gm IV on Treatment Day 1
Rituximab 1 gm IV on Treatment Day 15
Rituximab 1 gm IV on Treatment Day 168
Rituximab 1 gm IV on Treatment Day 182
An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407637|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement
ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407638|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement
Intravenous Rituximab: Rituximab Therapy [27 Patients]
Rituximab 1 gm IV on Treatment Day 1
Rituximab 1 gm IV on Treatment Day 15
Rituximab 1 gm IV on Treatment Day 168
Rituximab 1 gm IV on Treatment Day 182
An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407639|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement
ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407640|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement
Intravenous Rituximab: Rituximab Therapy [27 Patients]
Rituximab 1 gm IV on Treatment Day 1
Rituximab 1 gm IV on Treatment Day 15
Rituximab 1 gm IV on Treatment Day 168
Rituximab 1 gm IV on Treatment Day 182
An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407641|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement
ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407642|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement
Intravenous Rituximab: Rituximab Therapy [27 Patients]
Rituximab 1 gm IV on Treatment Day 1
Rituximab 1 gm IV on Treatment Day 15
Rituximab 1 gm IV on Treatment Day 168
Rituximab 1 gm IV on Treatment Day 182
An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407643|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement
ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407644|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement
Intravenous Rituximab: Rituximab Therapy [27 Patients]
Rituximab 1 gm IV on Treatment Day 1
Rituximab 1 gm IV on Treatment Day 15
Rituximab 1 gm IV on Treatment Day 168
Rituximab 1 gm IV on Treatment Day 182
An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407645|NCT00498368|E2|Reported Event|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement
ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407646|NCT00498368|E1|Reported Event|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement
Intravenous Rituximab: Rituximab Therapy [27 Patients]
Rituximab 1 gm IV on Treatment Day 1
Rituximab 1 gm IV on Treatment Day 15
Rituximab 1 gm IV on Treatment Day 168
Rituximab 1 gm IV on Treatment Day 182
An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury
Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
407647|NCT00498433|B4|Baseline|Total|Total of all reporting groups
407648|NCT00498433|B3|Baseline|Part 2, Double Blind: Amlodipine|Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
408569|NCT00508001|P1|Participant Flow|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
407649|NCT00498433|B2|Baseline|Part 2, Double Blind Period: Aliskiren|Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407650|NCT00498433|B1|Baseline|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407651|NCT00498433|P3|Participant Flow|Amlodipine|"Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.
Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks"
407652|NCT00498433|P2|Participant Flow|Aliskiren|"Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks"
407653|NCT00498433|P1|Participant Flow|Placebo|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 2, Period 1: After confirming study eligibility based on inclusion and exclusion criteria, patients underwent a two week single-blind placebo run-in phase."
407654|NCT00498433|O3|Outcome|Amlodipine|Part 2, Double Blind: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
407655|NCT00498433|O2|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407656|NCT00498433|O1|Outcome|Placebo run-in|Part 2, Period 1, Placebo run-in phase: After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.
407657|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
407658|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407659|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
407660|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407661|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
407662|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407663|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
407664|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407665|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
407666|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407667|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
407668|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407669|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407670|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407671|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407672|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407673|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407674|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407724|NCT00498602|P6|Participant Flow|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
409226|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
407761|NCT00498602|E4|Reported Event|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407675|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407676|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407677|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407678|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407679|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407680|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407681|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407682|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
407683|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407684|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
407685|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407686|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
407687|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407688|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407689|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.
Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
407690|NCT00498433|E5|Reported Event|Part 2: Amlodipine|Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
407691|NCT00498433|E4|Reported Event|Part 2: Aliskiren|Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
407692|NCT00498433|E3|Reported Event|Part 2: Placebo run-in Period|After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.
407693|NCT00498433|E2|Reported Event|Part 1: Amlodipine|All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.
407694|NCT00498433|E1|Reported Event|Part 1: Aliskiren|All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
407695|NCT00498485|B3|Baseline|Total|Total of all reporting groups
407696|NCT00498485|B2|Baseline|Xyrem|Xyrem: Same as for Placebo
407697|NCT00498485|B1|Baseline|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms and a computerized test to assess their degree of brain fog. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
407698|NCT00498485|P2|Participant Flow|Xyrem|Xyrem: Same as for Placebo
407725|NCT00498602|P5|Participant Flow|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407726|NCT00498602|P4|Participant Flow|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
425899|NCT00542425|O3|Outcome|BA058 40 µg|
407699|NCT00498485|P1|Participant Flow|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
407700|NCT00498485|O2|Outcome|Xyrem|Xyrem: Same as for Placebo
407701|NCT00498485|O1|Outcome|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
407702|NCT00498485|O2|Outcome|Drug Treated|Xyrem: Volunteers will complete questionnaires. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved.
407703|NCT00498485|O1|Outcome|Placebo|Xyrem: Volunteers will complete questionnaires. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved.
407704|NCT00498485|E2|Reported Event|Xyrem|Xyrem: Same as for Placebo
407705|NCT00498485|E1|Reported Event|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms and a computerized test to assess their degree of brain fog. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
407706|NCT00498550|B3|Baseline|Total|Total of all reporting groups
407707|NCT00498550|B2|Baseline|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
407708|NCT00498550|B1|Baseline|Clozapine|Clozapine, Clozaril
407709|NCT00498550|P2|Participant Flow|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
407710|NCT00498550|P1|Participant Flow|Clozapine|Clozapine, Clozaril
407711|NCT00498550|O2|Outcome|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
407712|NCT00498550|O1|Outcome|Clozapine|Clozapine, Clozaril
407713|NCT00498550|E2|Reported Event|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
407714|NCT00498550|E1|Reported Event|Clozapine|Clozapine, Clozaril
407715|NCT00498602|B8|Baseline|Total|Total of all reporting groups
407716|NCT00498602|B7|Baseline|Phosphate Buffered Saline|Participants received PBS. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407717|NCT00498602|B6|Baseline|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407718|NCT00498602|B5|Baseline|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407719|NCT00498602|B4|Baseline|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407720|NCT00498602|B3|Baseline|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407721|NCT00498602|B2|Baseline|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407722|NCT00498602|B1|Baseline|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407723|NCT00498602|P7|Participant Flow|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407727|NCT00498602|P3|Participant Flow|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407728|NCT00498602|P2|Participant Flow|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407729|NCT00498602|P1|Participant Flow|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407730|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407731|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407732|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407733|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407734|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407735|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407736|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407737|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407738|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407739|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407740|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407741|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407742|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407743|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407744|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407745|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407746|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407747|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407748|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407749|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407750|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407751|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407752|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407753|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407754|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407755|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407756|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407757|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407758|NCT00498602|E7|Reported Event|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407759|NCT00498602|E6|Reported Event|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407760|NCT00498602|E5|Reported Event|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
425900|NCT00542425|O2|Outcome|BA058 20 µg|
407762|NCT00498602|E3|Reported Event|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407763|NCT00498602|E2|Reported Event|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407764|NCT00498602|E1|Reported Event|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
407765|NCT00498615|B1|Baseline|3 Period Crossover Study ( All Participants)|"This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil (40 mg or 80 mg) or placebo administered 2 hours before a standardized cold challenge.
Men and women between ages 18–80 years with a clinical diagnosis of RP secondary to SSc were eligible for the study."
407766|NCT00498615|P6|Participant Flow|Sequence 6|Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
407767|NCT00498615|P5|Participant Flow|Sequence 5|Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
407768|NCT00498615|P4|Participant Flow|Sequence 4|Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
407769|NCT00498615|P3|Participant Flow|Sequence 3|Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
407770|NCT00498615|P2|Participant Flow|Sequence 2|Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
407771|NCT00498615|P1|Participant Flow|Sequence 1|Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods.
407772|NCT00498615|O3|Outcome|Placebo|"Time to reach 70% of skin temperature after cold challenge done 2 hrs after taking placebo
Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
407773|NCT00498615|O2|Outcome|40 mg Fasudil|"Time to reach 70% skin temperature after cold challenge done 2 hrs after dosing.
Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
407774|NCT00498615|O1|Outcome|Fasudil 80 mg|"Time to recover 70% of baseline skin temperature after cold challenge done 2 hrs after dose.
Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
407775|NCT00498615|O3|Outcome|Placebo|In this group participants received placebo 2 hours before cold challenge.
407776|NCT00498615|O2|Outcome|40 mg Fasudil|In this group participants received 40mg of Fasudil 2 hours before cold challenge
407777|NCT00498615|O1|Outcome|80 mg Fasudil|"This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil In this arm participants received 80 mg of Fasudil 2 hours before a standardized cold challenge.
Men and women between ages 18–80 years with a clinical diagnosis of Raynauds Phenomenon secondary to Scleroderma were eligible for the study."
407778|NCT00498615|O3|Outcome|Placebo|participants will receive placebo at 1 of 3 study periods. participants and researchers will not know which is received.
407779|NCT00498615|O2|Outcome|80 mg Fasudil|participants will receive 80mg of Fasudil at 1 one 3 study periods 2hrs before a cold challenge.
407907|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
408201|NCT00506831|O1|Outcome|Imatinib Mesylate|All patients were treated with imatinib mesylate at a mean dosage of 300 mg daily.
408202|NCT00506831|E1|Reported Event|Imatinib Mesylate|
407780|NCT00498615|O1|Outcome|40 mg Fasudil|This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil 40 mg administered 2 hours before a standardized cold challenge participant and researchers will not know what is received on the testing day.
407781|NCT00498615|E3|Reported Event|80mg Fasudil|80mg Fasudil was administered 2 hours before a standardized cold challenge.
407782|NCT00498615|E2|Reported Event|40 mg Fasudil|40 mg Fasudil was administered 2 hours before a standardized cold challenge.
407783|NCT00498615|E1|Reported Event|Placebo|Placebo was administered 2 hours before a standardized cold challenge.
407784|NCT00498628|B3|Baseline|Total|Total of all reporting groups
407785|NCT00498628|B2|Baseline|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
407786|NCT00498628|B1|Baseline|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
407787|NCT00498628|P2|Participant Flow|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
407788|NCT00498628|P1|Participant Flow|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
407789|NCT00498628|O2|Outcome|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
407790|NCT00498628|O1|Outcome|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
407791|NCT00498628|E2|Reported Event|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
407792|NCT00498628|E1|Reported Event|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
407793|NCT00498706|B3|Baseline|Total|Total of all reporting groups
407794|NCT00498706|B2|Baseline|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
407795|NCT00498706|B1|Baseline|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
407796|NCT00498706|P2|Participant Flow|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
407797|NCT00498706|P1|Participant Flow|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
407798|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
407799|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
407800|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
407801|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
407802|NCT00498706|O2|Outcome|Face-to-face Cognitive Behavioral Therapy|Participants will receive face-to-face cognitive behavioral therapy.
407803|NCT00498706|O1|Outcome|Telephone-administered Cognitive Behavioral Therapy|Participants will receive telephone-administered cognitive behavioral therapy.
407804|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
407805|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
407806|NCT00498706|E2|Reported Event|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
407807|NCT00498706|E1|Reported Event|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
407808|NCT00498797|B3|Baseline|Total|Total of all reporting groups
407809|NCT00498797|B2|Baseline|Placebo|docetaxel/prednisolone/placebo
407810|NCT00498797|B1|Baseline|Vandetanib|docetaxel/prednisolone/vandetanib
407811|NCT00498797|P2|Participant Flow|Placebo|docetaxel/prednisolone/placebo
407812|NCT00498797|P1|Participant Flow|Vandetanib|docetaxel/prednisolone/vandetanib
407813|NCT00498797|O2|Outcome|Placebo|docetaxel/prednisolone/placebo
407814|NCT00498797|O1|Outcome|Vandetanib|docetaxel/prednisolone/vandetanib
407815|NCT00498797|O2|Outcome|Placebo|docetaxel/prednisolone/placebo
407816|NCT00498797|O1|Outcome|Vandetanib|docetaxel/prednisolone/vandetanib
407817|NCT00498797|E2|Reported Event|Placebo|docetaxel/prednisolone/placebo
407818|NCT00498797|E1|Reported Event|Vandetanib|docetaxel/prednisolone/vandetanib
407819|NCT00498927|B1|Baseline|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
407820|NCT00498927|P1|Participant Flow|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
407821|NCT00498927|O1|Outcome|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
407822|NCT00498927|O1|Outcome|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
407823|NCT00498927|E1|Reported Event|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
407824|NCT00498940|B3|Baseline|Total|Total of all reporting groups
407937|NCT00499447|O1|Outcome|Radiofrequency Ablation Combined With External|
407938|NCT00499447|E1|Reported Event|Radiofrequency Ablation Combined With External|
425901|NCT00542425|O1|Outcome|Placebo|
407825|NCT00498940|B2|Baseline|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.
Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
407826|NCT00498940|B1|Baseline|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).
Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.
Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
407827|NCT00498940|P2|Participant Flow|Standard of Care|"No post operative pacing is to occur. Patients will undergo optimization testing.
Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass."
407828|NCT00498940|P1|Participant Flow|Biventricular Pacing|"After weaning from bypass, patients will receive temporary biventricular pacing for 24 hours. Values obtained from optimization testing will determine pacemaker settings (AVD, VVD, heart rate).
Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass.
Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours."
407829|NCT00498940|O2|Outcome|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.
Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
407830|NCT00498940|O1|Outcome|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).
Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.
Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
407831|NCT00498940|E2|Reported Event|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.
Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
407832|NCT00498940|E1|Reported Event|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).
Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.
Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
407833|NCT00499031|B1|Baseline|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
407834|NCT00499031|P1|Participant Flow|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
407835|NCT00499031|O1|Outcome|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
407836|NCT00499031|O1|Outcome|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
407837|NCT00499031|E1|Reported Event|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
407838|NCT00499096|B3|Baseline|Total|Total of all reporting groups
407839|NCT00499096|B2|Baseline|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease (CVD) will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
407840|NCT00499096|B1|Baseline|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease (CVD); group will receive self-management group sessions, followed by phone contacts by the Care Manager.
Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
407841|NCT00499096|P2|Participant Flow|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
407939|NCT00499460|B3|Baseline|Total|Total of all reporting groups
408195|NCT00506714|O2|Outcome|Group 2|Adults with symptomatic hip osteoarthritis walking without a cane at baseline
407842|NCT00499096|P1|Participant Flow|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.
Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
407843|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
407844|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.
Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
407845|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
407846|NCT00499096|O1|Outcome|Chonic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.
Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
407847|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
407848|NCT00499096|O1|Outcome|Chonic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.
Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
407849|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
407850|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. This is the chronic care model for bipolar disorder
Chronic care model for Bipolar Disorder: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
407851|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
407852|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.
Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
407853|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
407854|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. This is the chronic care model for bipolar disorder
Chronic care model for Bipolar Disorder: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
425902|NCT00542425|O5|Outcome|Teriparatide|
407855|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
407856|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.
Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
407857|NCT00499096|E2|Reported Event|Arm 2|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
407858|NCT00499096|E1|Reported Event|Arm 1|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.
Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
407859|NCT00499109|B3|Baseline|Total|Total of all reporting groups
407860|NCT00499109|B2|Baseline|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).
All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
407861|NCT00499109|B1|Baseline|E. Dual Agent Chemotherapy|"Experimental Arm E.
Patients received treatment according to gene expression strata with four doublet regimens.
Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.
Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.
High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.
High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
407862|NCT00499109|P2|Participant Flow|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).
All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
407863|NCT00499109|P1|Participant Flow|E. Dual Agent Chemotherapy|"Experimental Arm E.
Patients received treatment according to gene expression strata with four doublet regimens.
Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.
Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.
High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.
High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
407864|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).
All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
407865|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.
Patients received treatment according to gene expression strata with four doublet regimens.
Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.
Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.
High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.
High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
407866|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).
All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
407867|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.
Patients received treatment according to gene expression strata with four doublet regimens.
Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.
Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.
High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.
High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
407868|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).
All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
407869|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.
Patients received treatment according to gene expression strata with four doublet regimens.
Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.
Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.
High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.
High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
407870|NCT00499109|E5|Reported Event|Control: C|Gemcitabine/Carboplatin
407871|NCT00499109|E4|Reported Event|Experimental: E4|Gemcitabine/Carboplatin
407872|NCT00499109|E3|Reported Event|Experimental: E3|Gemcitabine/Docetaxel
407873|NCT00499109|E2|Reported Event|Experimental: E2|Docetaxel/Carboplatin
407874|NCT00499109|E1|Reported Event|Experimental: E1|Docetaxel/Vinorelbine
407875|NCT00499122|B1|Baseline|NOV-002 and Chemotherapy|"NOV-002:
Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart
Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration
Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections
Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1
Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1
Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
407876|NCT00499122|P1|Participant Flow|NOV-002 and Chemotherapy|"NOV-002:
Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart
Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration
Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections
Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1
Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1
Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
407877|NCT00499122|O1|Outcome|NOV-002 and Chemotherapy|"NOV-002:
Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart
Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration
Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections
Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1
Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1
Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1
Cyclophosphamide
Docetaxel
Doxorubicin
NOV 002"
407878|NCT00499122|O1|Outcome|NOV-002 and Chemotherapy|"NOV-002:
Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart
Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration
Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections
Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1
Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1
Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
407879|NCT00499122|E1|Reported Event|NOV-002 and Chemotherapy|"NOV-002:
Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart
Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration
Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections
Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1
Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1
Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
407880|NCT00499252|B1|Baseline|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
407881|NCT00499252|P1|Participant Flow|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
407882|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
407883|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
407884|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
407885|NCT00499252|E1|Reported Event|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
407886|NCT00499343|B3|Baseline|Total|Total of all reporting groups
407887|NCT00499343|B2|Baseline|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
407888|NCT00499343|B1|Baseline|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
407889|NCT00499343|P2|Participant Flow|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
407890|NCT00499343|P1|Participant Flow|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
407891|NCT00499343|O2|Outcome|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
407892|NCT00499343|O1|Outcome|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
407893|NCT00499343|E2|Reported Event|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
407894|NCT00499343|E1|Reported Event|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
407895|NCT00499369|B6|Baseline|Total|Total of all reporting groups
407896|NCT00499369|B5|Baseline|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407897|NCT00499369|B4|Baseline|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407898|NCT00499369|B3|Baseline|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407899|NCT00499369|B2|Baseline|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407900|NCT00499369|B1|Baseline|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407901|NCT00499369|P5|Participant Flow|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407902|NCT00499369|P4|Participant Flow|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407903|NCT00499369|P3|Participant Flow|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407904|NCT00499369|P2|Participant Flow|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407905|NCT00499369|P1|Participant Flow|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407906|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
425903|NCT00542425|O4|Outcome|BA058 80 µg|
407908|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407909|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407910|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407911|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407912|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407913|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407914|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407915|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407916|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407917|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407918|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407919|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407920|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407921|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407922|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407923|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407924|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407925|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407926|NCT00499369|E5|Reported Event|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407927|NCT00499369|E4|Reported Event|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407928|NCT00499369|E3|Reported Event|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407929|NCT00499369|E2|Reported Event|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407930|NCT00499369|E1|Reported Event|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
407931|NCT00499408|B1|Baseline|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
407932|NCT00499408|P1|Participant Flow|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
407933|NCT00499408|O1|Outcome|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
407934|NCT00499408|E1|Reported Event|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
407935|NCT00499447|B1|Baseline|Radiofrequency Ablation Combined With External|
407936|NCT00499447|P1|Participant Flow|Radiofrequency Ablation Combined With External|
407940|NCT00499460|B2|Baseline|Placebo First, Then Garlic|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
407941|NCT00499460|B1|Baseline|Garlic First, Then Placebo|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
407942|NCT00499460|P2|Participant Flow|Placebo First, Then Garlic|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
407943|NCT00499460|P1|Participant Flow|Garlic First, Then Placebo|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
407944|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of oral digoxin AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
407945|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of oral digoxin AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
407946|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of oral midazolam AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
407947|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of oral midazolam AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
407948|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of CASE Total Score following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
407949|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of CASE Total Score following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
407950|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of SSE Total Score following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
407951|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of SSE Total Score following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
407952|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of Cold Pressor Test Tolerance AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
407953|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of Cold Pressor Test Tolerance AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
407954|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of oxycodone oral clearance following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
407955|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of oxycodone oral clearance following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
407956|NCT00499460|E2|Reported Event|Placebo|Data for all subjects during their placebo treatment period in both arms were pooled.
407957|NCT00499460|E1|Reported Event|Garlic|Data for all subjects during their active garlic treatment period in both arms were pooled.
407958|NCT00499473|B3|Baseline|Total|Total of all reporting groups
407959|NCT00499473|B2|Baseline|Stratum 2: Patients on EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
407960|NCT00499473|B1|Baseline|Stratum I: Patients Not on EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
407961|NCT00499473|P2|Participant Flow|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
407962|NCT00499473|P1|Participant Flow|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
407963|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
407964|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
407965|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
407966|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
407967|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
407968|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
407969|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
407970|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
407971|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
407972|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
407973|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
407974|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
407975|NCT00499473|E2|Reported Event|Stratum 2: EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib. In addition to EIAC (Enzyme-inducing anticonvulsant)
407976|NCT00499473|E1|Reported Event|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
407977|NCT00499486|B1|Baseline|Sirolimus|adencarcinoma refractory to gemcitibine
407978|NCT00499486|P1|Participant Flow|Sirolimus|Patients with advanced pancreatic adenocarcinoma refractory to gemcitibine received Sirolimus at a single oral flat dose of 5 mg. per day. A treatment cycle was 28 days.
407979|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
407980|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
407981|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
407982|NCT00499486|E1|Reported Event|Sirolimus|Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days.
407983|NCT00499590|B4|Baseline|Total|Total of all reporting groups
407984|NCT00499590|B3|Baseline|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
407985|NCT00499590|B2|Baseline|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
407986|NCT00499590|B1|Baseline|Lucentis|"Lucentis® (0.5mg) every 4 weeks.
ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
407987|NCT00499590|P3|Participant Flow|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
407988|NCT00499590|P2|Participant Flow|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
407989|NCT00499590|P1|Participant Flow|Lucentis®|"Lucentis® (0.5mg) every 4 weeks.
ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
407990|NCT00499590|O3|Outcome|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
407991|NCT00499590|O2|Outcome|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
407992|NCT00499590|O1|Outcome|Lucentis|"Lucentis® (0.5mg) every 4 weeks.
ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
407993|NCT00499590|O3|Outcome|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
407994|NCT00499590|O2|Outcome|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
407995|NCT00499590|O1|Outcome|Lucentis®|"Lucentis® (0.5mg) every 4 weeks.
ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
407996|NCT00499590|E3|Reported Event|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
408114|NCT00506077|B1|Baseline|MK0249 Then Placebo|These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
407997|NCT00499590|E2|Reported Event|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
407998|NCT00499590|E1|Reported Event|Lucentis|"Lucentis® (0.5mg) every 4 weeks.
ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
407999|NCT00499603|B3|Baseline|Total|Total of all reporting groups
408000|NCT00499603|B2|Baseline|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.
Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408001|NCT00499603|B1|Baseline|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408002|NCT00499603|P2|Participant Flow|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.
Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408003|NCT00499603|P1|Participant Flow|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408004|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.
Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408005|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408006|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.
Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408007|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408008|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.
Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408009|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408010|NCT00499603|E2|Reported Event|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.
Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408115|NCT00506077|P2|Participant Flow|Placebo Then MK0249|These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
408116|NCT00506077|P1|Participant Flow|MK0249 Then Placebo|These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
408011|NCT00499603|E1|Reported Event|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).
5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
408012|NCT00499616|B5|Baseline|Total|Total of all reporting groups
408013|NCT00499616|B4|Baseline|Non-intermediate Risk Enrolled on Intermediate Risk Trial|"The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531.
Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished."
408014|NCT00499616|B3|Baseline|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S disease who achieve a very good PR (VGPR) to chemo (with the exception of resolution of skin or liver metastases in stage 4S patients) proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408015|NCT00499616|B2|Baseline|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408016|NCT00499616|B1|Baseline|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
408017|NCT00499616|P4|Participant Flow|Non-intermediate Risk Enrolled on Intermediate Risk Trial|"The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531.
Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished."
408018|NCT00499616|P3|Participant Flow|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408019|NCT00499616|P2|Participant Flow|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408020|NCT00499616|P1|Participant Flow|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
408021|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408022|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408023|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
408024|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408196|NCT00506714|O1|Outcome|Group 1|Healthy adults walking without a cane at baseline
408025|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408026|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
408027|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408028|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408029|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
408030|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408031|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408032|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
408033|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408034|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408035|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
408036|NCT00499616|O1|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408037|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408197|NCT00506714|E2|Reported Event|Group 2|Adults with symptomatic hip osteoarthritis
408198|NCT00506714|E1|Reported Event|Group 1|Healthy adults
408199|NCT00506831|B1|Baseline|Imatinib Mesylate|
408038|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408039|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
408040|NCT00499616|O2|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408041|NCT00499616|O1|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408042|NCT00499616|O2|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408043|NCT00499616|O1|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408044|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408045|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408046|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
408047|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408048|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408049|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
408050|NCT00499616|E4|Reported Event|Non-intermediate Risk Enrolled on Intermediate Risk Trial|"The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531.
Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished."
408117|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408051|NCT00499616|E3|Reported Event|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408052|NCT00499616|E2|Reported Event|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
408053|NCT00499616|E1|Reported Event|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
408054|NCT00499655|B3|Baseline|Total|Total of all reporting groups
408055|NCT00499655|B2|Baseline|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.
erlotinib hydrochloride: Given orally
celecoxib: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408056|NCT00499655|B1|Baseline|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
erlotinib hydrochloride: Given orally
placebo: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408057|NCT00499655|P2|Participant Flow|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.
erlotinib hydrochloride: Given orally
celecoxib: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408058|NCT00499655|P1|Participant Flow|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
erlotinib hydrochloride: Given orally
placebo: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408059|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg oforal erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.
erlotinib hydrochloride: Given orally
celecoxib: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408060|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
erlotinib hydrochloride: Given orally
placebo: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408061|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.
erlotinib hydrochloride: Given orally
celecoxib: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408062|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
erlotinib hydrochloride: Given orally
placebo: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408063|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.
erlotinib hydrochloride: Given orally
celecoxib: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408064|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
erlotinib hydrochloride: Given orally
placebo: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408065|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.
erlotinib hydrochloride: Given orally
celecoxib: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408200|NCT00506831|P1|Participant Flow|Imatinib Mesylate|
408066|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
erlotinib hydrochloride: Given orally
placebo: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408067|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.
erlotinib hydrochloride: Given orally
celecoxib: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408068|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
erlotinib hydrochloride: Given orally
placebo: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408069|NCT00499655|E2|Reported Event|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.
erlotinib hydrochloride: Given orally
celecoxib: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408070|NCT00499655|E1|Reported Event|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
erlotinib hydrochloride: Given orally
placebo: Given orally
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
fluorescence in situ hybridization: Correlative studies
mutation analysis: Correlative studies
protein expression analysis: Correlative studies
gene expression analysis: Correlative studies"
408071|NCT00499681|B3|Baseline|Total|Total of all reporting groups
408072|NCT00499681|B2|Baseline|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
408073|NCT00499681|B1|Baseline|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
408074|NCT00499681|P2|Participant Flow|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
408075|NCT00499681|P1|Participant Flow|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
408076|NCT00499681|O2|Outcome|Part 1: Letrozole Plus Placebo Part II Letrozole Plus Laptinab|Participants received 2 weeks treatment with letrozole with a placebo and 14 weeks treatment with letrozole and lapatinib
408077|NCT00499681|O1|Outcome|Part I and Part II Letrozole Plus Laptinab|Participants received 2 weeks treatment with letrozole with lapatinib and 14 weeks treatment with letrozole and lapatinib
408078|NCT00499681|E2|Reported Event|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
408079|NCT00499681|E1|Reported Event|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
408080|NCT00499694|B1|Baseline|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days
bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
408081|NCT00499694|P1|Participant Flow|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days
bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
408082|NCT00499694|O1|Outcome|Bevacizumab and Satraplatin|"Bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) Bevacizumab: 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
Satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
408083|NCT00499694|E1|Reported Event|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days
bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
408118|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
425904|NCT00542425|O3|Outcome|BA058 40 µg|
408084|NCT00505934|B1|Baseline|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
408085|NCT00505934|P1|Participant Flow|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
408086|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
408087|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
408088|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
408089|NCT00505934|E1|Reported Event|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
408090|NCT00506025|B4|Baseline|Total|Total of all reporting groups
408091|NCT00506025|B3|Baseline|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
408092|NCT00506025|B2|Baseline|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
408093|NCT00506025|B1|Baseline|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
408094|NCT00506025|P3|Participant Flow|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
408095|NCT00506025|P2|Participant Flow|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
408096|NCT00506025|P1|Participant Flow|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
408097|NCT00506025|O3|Outcome|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
408098|NCT00506025|O2|Outcome|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
408099|NCT00506025|O1|Outcome|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
408100|NCT00506025|E3|Reported Event|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
408101|NCT00506025|E2|Reported Event|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
408102|NCT00506025|E1|Reported Event|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
408103|NCT00506064|B3|Baseline|Total|Total of all reporting groups
408104|NCT00506064|B2|Baseline|Placebo|Starch capsules by mouth daily
408105|NCT00506064|B1|Baseline|Melatonin|0.15 mg/kg capsules by mouth daily
408106|NCT00506064|P2|Participant Flow|Placebo|Starch capsules by mouth daily
408107|NCT00506064|P1|Participant Flow|Melatonin|0.15 mg/kg capsules by mouth daily
408108|NCT00506064|O2|Outcome|Placebo|Starch capsules by mouth daily
408109|NCT00506064|O1|Outcome|Melatonin|0.15 mg/kg capsules by mouth daily
408110|NCT00506064|E2|Reported Event|Placebo|Starch capsules by mouth daily
408111|NCT00506064|E1|Reported Event|Melatonin|0.15 mg/kg capsules by mouth daily
408112|NCT00506077|B3|Baseline|Total|Total of all reporting groups
408113|NCT00506077|B2|Baseline|Placebo Then MK0249|These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
408119|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408120|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408121|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408122|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408123|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408124|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408125|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408126|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408127|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408128|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408129|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408130|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408131|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408132|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408133|NCT00506077|E2|Reported Event|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408134|NCT00506077|E1|Reported Event|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
408135|NCT00506155|B1|Baseline|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
408136|NCT00506155|P1|Participant Flow|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
408137|NCT00506155|O1|Outcome|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
408138|NCT00506155|O1|Outcome|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
408139|NCT00506155|E1|Reported Event|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
408140|NCT00506662|B3|Baseline|Total|Total of all reporting groups
408141|NCT00506662|B2|Baseline|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408142|NCT00506662|B1|Baseline|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408143|NCT00506662|P2|Participant Flow|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408144|NCT00506662|P1|Participant Flow|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408145|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408146|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408147|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408148|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408149|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408150|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408151|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408152|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408153|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408154|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408155|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408156|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408157|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408158|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408159|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408160|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408161|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408162|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408163|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408164|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408165|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408166|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408167|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408168|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408169|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408170|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408171|NCT00506662|E2|Reported Event|Insulin NPH|Individually adjusted dose of insulin NPH once daily
408172|NCT00506662|E1|Reported Event|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
408173|NCT00506675|B3|Baseline|Total|Total of all reporting groups
408174|NCT00506675|B2|Baseline|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
408175|NCT00506675|B1|Baseline|Intensive|6 hours daily patching combined with daily atropine
408176|NCT00506675|P2|Participant Flow|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
408177|NCT00506675|P1|Participant Flow|Intensive|6 hours daily patching combined with daily atropine
408178|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
408179|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
408180|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
408181|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
408182|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
408183|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
408184|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
408185|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
408186|NCT00506675|E2|Reported Event|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
408187|NCT00506675|E1|Reported Event|Intensive|6 hours daily patching combined with daily atropine
408188|NCT00506714|B3|Baseline|Total|Total of all reporting groups
408189|NCT00506714|B2|Baseline|Group 2|Adults with symptomatic hip osteoarthritis
408190|NCT00506714|B1|Baseline|Group 1|Healthy adults
408191|NCT00506714|P2|Participant Flow|Group 2|Adults with symptomatic hip osteoarthritis
408192|NCT00506714|P1|Participant Flow|Group 1|Healthy adults
408193|NCT00506714|O1|Outcome|Group 2|Adults with symptomatic hip osteoarthritis after four weeks of cane use
408194|NCT00506714|O1|Outcome|Group 2|Adults with symptomatic hip osteoarthritis walking with a cane at baseline
409227|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
408203|NCT00506857|B1|Baseline|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
408204|NCT00506857|P1|Participant Flow|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
408205|NCT00506857|O1|Outcome|Tacrolimus + Methotrexate|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
408206|NCT00506857|O1|Outcome|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
408207|NCT00506857|E1|Reported Event|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
408208|NCT00506883|B4|Baseline|Total|Total of all reporting groups
408209|NCT00506883|B3|Baseline|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
408210|NCT00506883|B2|Baseline|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
408211|NCT00506883|B1|Baseline|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
408212|NCT00506883|P3|Participant Flow|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
408213|NCT00506883|P2|Participant Flow|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
408214|NCT00506883|P1|Participant Flow|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
408215|NCT00506883|O3|Outcome|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
408216|NCT00506883|O2|Outcome|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
408217|NCT00506883|O1|Outcome|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
408218|NCT00506883|E3|Reported Event|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
408219|NCT00506883|E2|Reported Event|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
408220|NCT00506883|E1|Reported Event|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
408221|NCT00506922|B6|Baseline|Total|Total of all reporting groups
408222|NCT00506922|B5|Baseline|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
408223|NCT00506922|B4|Baseline|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
408224|NCT00506922|B3|Baseline|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
408225|NCT00506922|B2|Baseline|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
408226|NCT00506922|B1|Baseline|No Pentostatin|Group 1: No Pentostatin
408227|NCT00506922|P5|Participant Flow|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
408228|NCT00506922|P4|Participant Flow|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
408229|NCT00506922|P3|Participant Flow|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
408230|NCT00506922|P2|Participant Flow|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
408231|NCT00506922|P1|Participant Flow|No Pentostatin|Group 1: No Pentostatin
408232|NCT00506922|O1|Outcome|Pentostatin|150 patients were enrolled, 2 patients not treated, 38 patients were Group 1 (no Pentostatin), the remaining Groups 2,3,4 and 5, 110 patients were analysed that received the Pentostatin.
408233|NCT00506922|E5|Reported Event|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
408234|NCT00506922|E4|Reported Event|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
408235|NCT00506922|E3|Reported Event|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
408236|NCT00506922|E2|Reported Event|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
408237|NCT00506922|E1|Reported Event|No Pentostatin|Group 1: No Pentostatin
408238|NCT00506948|B1|Baseline|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
408239|NCT00506948|P1|Participant Flow|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
408290|NCT00507130|E1|Reported Event|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408291|NCT00507208|B3|Baseline|Total|Total of all reporting groups
408240|NCT00506948|O1|Outcome|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
408241|NCT00506948|E1|Reported Event|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
408242|NCT00507130|B5|Baseline|Total|Total of all reporting groups
408243|NCT00507130|B4|Baseline|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408244|NCT00507130|B3|Baseline|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408245|NCT00507130|B2|Baseline|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408246|NCT00507130|B1|Baseline|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408247|NCT00507130|P4|Participant Flow|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408248|NCT00507130|P3|Participant Flow|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408249|NCT00507130|P2|Participant Flow|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408250|NCT00507130|P1|Participant Flow|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408251|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408252|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408253|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408254|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408255|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408256|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408257|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408258|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408259|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408260|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408261|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408262|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408263|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408264|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408265|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408266|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408267|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408268|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408269|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408270|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408271|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408272|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408273|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408274|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408275|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408276|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408277|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408278|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408279|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408280|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408281|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408282|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408283|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408284|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408285|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408286|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
408287|NCT00507130|E4|Reported Event|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
408288|NCT00507130|E3|Reported Event|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
408289|NCT00507130|E2|Reported Event|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
408292|NCT00507208|B2|Baseline|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
408293|NCT00507208|B1|Baseline|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
408294|NCT00507208|P2|Participant Flow|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
408295|NCT00507208|P1|Participant Flow|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
408296|NCT00507208|O2|Outcome|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
408297|NCT00507208|O1|Outcome|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
408298|NCT00507208|E2|Reported Event|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
408299|NCT00507208|E1|Reported Event|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
408300|NCT00507416|B4|Baseline|Total|Total of all reporting groups
408301|NCT00507416|B3|Baseline|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408302|NCT00507416|B2|Baseline|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408303|NCT00507416|B1|Baseline|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408304|NCT00507416|P3|Participant Flow|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408305|NCT00507416|P2|Participant Flow|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408306|NCT00507416|P1|Participant Flow|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408307|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408308|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408309|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408310|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408311|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408312|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408411|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
409228|NCT00509197|O2|Outcome|Placebo|Treatment with placebo
408414|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408570|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
408313|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408314|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408315|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408316|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408317|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408318|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408319|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408320|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408321|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408322|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408323|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408324|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408325|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408326|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408327|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408328|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408329|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
409229|NCT00509197|O1|Outcome|Fluticasone|Treatment with Fluticasone
408330|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408331|NCT00507416|E3|Reported Event|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408332|NCT00507416|E2|Reported Event|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408333|NCT00507416|E1|Reported Event|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
408334|NCT00507429|B3|Baseline|Total|Total of all reporting groups
408335|NCT00507429|B2|Baseline|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
408336|NCT00507429|B1|Baseline|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
408337|NCT00507429|P2|Participant Flow|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
408338|NCT00507429|P1|Participant Flow|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
408339|NCT00507429|O2|Outcome|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
408340|NCT00507429|O1|Outcome|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
408341|NCT00507429|O2|Outcome|Arm 2, Comparator: Carboplatin + Paclitaxel|Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
408342|NCT00507429|O1|Outcome|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
408343|NCT00507429|E2|Reported Event|Arm 2, Comparator: Carboplatin + Paclitaxel|Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
408344|NCT00507429|E1|Reported Event|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
408345|NCT00507442|B5|Baseline|Total|Total of all reporting groups
408346|NCT00507442|B4|Baseline|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408347|NCT00507442|B3|Baseline|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408348|NCT00507442|B2|Baseline|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408349|NCT00507442|B1|Baseline|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408350|NCT00507442|P4|Participant Flow|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408351|NCT00507442|P3|Participant Flow|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408412|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
409230|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
408352|NCT00507442|P2|Participant Flow|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408353|NCT00507442|P1|Participant Flow|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408354|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408355|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408356|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408357|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408358|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408359|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408360|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408361|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408362|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408363|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408364|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408365|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408366|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408367|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408368|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408369|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408413|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
425905|NCT00542425|O2|Outcome|BA058 20 µg|
408370|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408371|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408372|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408373|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408374|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408375|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408376|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408377|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408378|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408379|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408380|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408381|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408382|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408383|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408384|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408385|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408386|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408387|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408388|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
425906|NCT00542425|O1|Outcome|Placebo|
408389|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408390|NCT00507442|O4|Outcome|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408391|NCT00507442|O3|Outcome|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408392|NCT00507442|O2|Outcome|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408393|NCT00507442|O1|Outcome|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408394|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408395|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408396|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408397|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408398|NCT00507442|E4|Reported Event|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
408399|NCT00507442|E3|Reported Event|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
408400|NCT00507442|E2|Reported Event|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408401|NCT00507442|E1|Reported Event|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
408402|NCT00507455|B4|Baseline|Total|Total of all reporting groups
408403|NCT00507455|B3|Baseline|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408404|NCT00507455|B2|Baseline|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408405|NCT00507455|B1|Baseline|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408406|NCT00507455|P3|Participant Flow|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS)tablets for 12 weeks.
408407|NCT00507455|P2|Participant Flow|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets for 12 weeks.
408408|NCT00507455|P1|Participant Flow|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408409|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408410|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408563|NCT00508001|B4|Baseline|Total|Total of all reporting groups
408415|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408416|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408417|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408418|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408419|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408420|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408421|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408422|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408423|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408424|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408425|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408426|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408427|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408428|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408429|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408430|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408431|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408432|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408433|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408434|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408435|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408436|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408437|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408438|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408439|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408440|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408441|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408442|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408443|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408444|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408445|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408446|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408447|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408448|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408449|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408450|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408451|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408452|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408453|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408454|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408455|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408456|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408457|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408458|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408459|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408460|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408461|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408462|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408463|NCT00507455|E3|Reported Event|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408464|NCT00507455|E2|Reported Event|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
408465|NCT00507455|E1|Reported Event|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
408466|NCT00507507|B3|Baseline|Total|Total of all reporting groups
408467|NCT00507507|B2|Baseline|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408468|NCT00507507|B1|Baseline|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408469|NCT00507507|P2|Participant Flow|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408470|NCT00507507|P1|Participant Flow|Tenofovir DF|Participants were randomized to receive tenofovir disoproxil fumarate (tenofovir DF; 300 mg tablet) plus placebo to match emtricitabine (FTC; tablet) orally once daily.
408471|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408472|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408473|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408474|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408475|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408476|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408477|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408478|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408479|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408480|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408481|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408482|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408483|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408484|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408485|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408486|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408487|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408488|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408489|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408490|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408491|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408492|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408493|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408494|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408564|NCT00508001|B3|Baseline|Placebo|Placebo plus Best Support Care
408495|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
408496|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
408497|NCT00507507|E4|Reported Event|FTC+Tenofovir DF (24-week Treatment-free Follow-up Period)|"This reporting group includes participants randomized to the FTC+Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.
AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only."
408498|NCT00507507|E3|Reported Event|Tenofovir DF (24-week Treatment-free Follow-up Period)|"This reporting group includes participants randomized to the Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.
AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only."
408499|NCT00507507|E2|Reported Event|FTC+Tenofovir DF (Treatment Period)|"Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
AEs for this reporting group are reported for the entire treatment period."
408500|NCT00507507|E1|Reported Event|Tenofovir DF (Treatment Period)|"Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
Adverse events (AEs) for this reporting group are reported for the entire treatment period."
408501|NCT00507546|B3|Baseline|Total|Total of all reporting groups
408502|NCT00507546|B2|Baseline|Arm 2|"Placebo then ramelteon
Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
408503|NCT00507546|B1|Baseline|Arm 1|"Ramelteon then placebo
Ramelteon : 8 mg nightly"
408504|NCT00507546|P2|Participant Flow|Arm 2|"Placebo then ramelteon
Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
408505|NCT00507546|P1|Participant Flow|Arm 1|"Ramelteon then placebo
Ramelteon : 8 mg nightly"
408506|NCT00507546|O2|Outcome|Arm 2|"Placebo then ramelteon
Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
408507|NCT00507546|O1|Outcome|Arm 1|"Ramelteon then placebo
Ramelteon : 8 mg nightly"
408508|NCT00507546|O2|Outcome|Placebo|"Placebo then ramelteon
Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
408509|NCT00507546|O1|Outcome|Ramelteon|"Ramelteon then placebo
Ramelteon : 8 mg nightly"
408510|NCT00507546|E2|Reported Event|Arm 2|"Placebo then ramelteon
Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
408511|NCT00507546|E1|Reported Event|Arm 1|"Ramelteon then placebo
Ramelteon : 8 mg nightly"
408512|NCT00507559|B1|Baseline|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408513|NCT00507559|P1|Participant Flow|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408514|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408515|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408516|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408517|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408518|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408519|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408520|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408521|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408522|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408523|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408524|NCT00507559|E1|Reported Event|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
408525|NCT00507689|B4|Baseline|Total|Total of all reporting groups
408526|NCT00507689|B3|Baseline|Not Randomized|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period only. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408527|NCT00507689|B2|Baseline|FTC/TDF|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408528|NCT00507689|B1|Baseline|FTC/TDF+HBIg|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408529|NCT00507689|P2|Participant Flow|FTC/TDF|For the Participant Flow, this group includes participants who received FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily.
408530|NCT00507689|P1|Participant Flow|FTC/TDF+HBIg|For the Participant Flow, this group includes all participants who received any treatment in the pre-randomization period, and participants who received FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408531|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408532|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408565|NCT00508001|B2|Baseline|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
408566|NCT00508001|B1|Baseline|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
408567|NCT00508001|P3|Participant Flow|Placebo|Placebo plus Best Support Care
408533|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408534|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408535|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408536|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408537|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408538|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408539|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408540|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408541|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408542|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408543|NCT00507689|E3|Reported Event|FTC/TDF, Randomized Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408544|NCT00507689|E2|Reported Event|FTC/TDF+HBIg, Randomized Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408545|NCT00507689|E1|Reported Event|FTC/TDF+HBIg, Pre-randomization Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the pre-randomization period, and were analyzed from pretreatment baseline to Week 24 (pre-randomization period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
408546|NCT00507767|B1|Baseline|Dasatinib|100 mg orally twice daily
408547|NCT00507767|P1|Participant Flow|Dasatinib|100 mg orally twice daily
408548|NCT00507767|O1|Outcome|Dasatinib|100 mg orally twice daily
408549|NCT00507767|E1|Reported Event|Dasatinib|100 mg orally twice daily
408550|NCT00507819|B1|Baseline|Study Population|Subjects who were randomized to receive either Sildenafil 20mg three times a day by mouth or Placebo three times a day by mouth.
408551|NCT00507819|P2|Participant Flow|Placebo, Then Sildenafil|Placebo six weeks followed by a six week washout period followed by Sildenafil which will be given at a dose of 20 mg three times-a-day for six weeks
408552|NCT00507819|P1|Participant Flow|Sildenafil, Then Placebo|Sildenafil will be given at a dose of 20 mg three times-a-day for six weeks followed by a six week washout period followed by placebo for an additional six weeks.
408553|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
408554|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
408555|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
408556|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
408557|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
408558|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
408559|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
408560|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
408561|NCT00507819|E2|Reported Event|Placebo|Placebo was given by mouth three times a day for six weeks
408562|NCT00507819|E1|Reported Event|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
408571|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
408572|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
408573|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
408574|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
408575|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
408576|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
408577|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
408578|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
408579|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
408580|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
408581|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
408582|NCT00508001|E3|Reported Event|Placebo|Placebo plus Best Support Care
408583|NCT00508001|E2|Reported Event|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
408584|NCT00508001|E1|Reported Event|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
408585|NCT00508027|B1|Baseline|Simvastatin, Dose Escalation|"There are no arms in this study. Simvastatin will be given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).
Simvastatin : Comparison of 3 dosages of simvastatin given in a dose-escalating fashion.
20 mg, 40 mg, or 80 mg PO QD x 21 days followed by a drug taper x 4 days."
408586|NCT00508027|P1|Participant Flow|Simvastatin, 3 Escalating Dose Groups|"Simvastatin was given in a dose-escalating fashion to 3 sequential dose groups:
dose level 1= 20 mg/day, dose level 2= 40 mg/day, dose level 3= 80 mg/day The number of subjects starting each dose level are new cohorts of subjects.
Determination of clinical safety in the first dose level group was required in order to begin enrollment in the second dose level group and ultimately the third dose group. Enrollment in the third dose level was discontinued early due to newly reported FDA warnings regarding high dose (80mg/day) simvastatin."
408587|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
408588|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
408589|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
408590|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
408591|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
408592|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
408593|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
408594|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
408595|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
408596|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
408597|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
408598|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
408599|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|"Subjects received 80 mg daily. Data collected for only 2 participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage"
408600|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
408601|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
408602|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
408603|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
408604|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
408605|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
408606|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
408607|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
408608|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
408609|NCT00508027|O2|Outcome|Dose Level 2|All participants received 40 mg of simvastatin once daily
408610|NCT00508027|O1|Outcome|Dose Level 1|All participants received 20mg simvastatin once daily
408611|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
408612|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
408613|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
408930|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408614|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
408615|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
408616|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
408617|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; biomarker data were not collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
408618|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
408619|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
408620|NCT00508027|E3|Reported Event|Simvastatin, Dose 3|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).
Dose 3 = 80mg/day for 21 days, followed by 4-day drug taper. Enrollment in this group discontinued early due to FDA warning re. high dose simvastatin"
408621|NCT00508027|E2|Reported Event|Simvastatin, Dose 2|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).
Dose 2 = 40mg/day for 21 days, followed by a 4-day taper."
408622|NCT00508027|E1|Reported Event|Simvastatin, Dose 1|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).
Dose 1 = 20mg/day for 21 days, followed by 4-day drug taper."
408623|NCT00508118|B3|Baseline|Total|Total of all reporting groups
408624|NCT00508118|B2|Baseline|0.9% Saline|0.9% saline (placebo) before bypass
408625|NCT00508118|B1|Baseline|Nicardipine|Nicardipine infusion before bypass
408626|NCT00508118|P2|Participant Flow|0.9% Saline|0.9% saline (placebo) infusion before bypass
408627|NCT00508118|P1|Participant Flow|Nicardipine|"Nicardipine infusion before bypass
After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
408628|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
408629|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass
After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
408630|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
408631|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass
After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
408632|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
408633|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass
After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
408634|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
408635|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass
After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
408636|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
408660|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408685|NCT00508391|B1|Baseline|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
408637|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass
After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
408638|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
408639|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass
After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
408640|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
408641|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass
After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
408642|NCT00508118|O1|Outcome|NICARDIPINE GROUP|Nicardipine prior to bypass
408643|NCT00508118|E2|Reported Event|0.9% Saline|0.9% saline (placebo) before bypass
408644|NCT00508118|E1|Reported Event|Nicardipine|Nicardipine infusion before bypass
408645|NCT00508144|B1|Baseline|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
408646|NCT00508144|P1|Participant Flow|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
408647|NCT00508144|O1|Outcome|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
408648|NCT00508144|E1|Reported Event|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
408649|NCT00508157|B3|Baseline|Total|Total of all reporting groups
408650|NCT00508157|B2|Baseline|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408651|NCT00508157|B1|Baseline|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
408652|NCT00508157|P2|Participant Flow|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408653|NCT00508157|P1|Participant Flow|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
408654|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408655|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
408656|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408657|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
408658|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408659|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
409231|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
408661|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
408662|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408663|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
408664|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408665|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
408666|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408667|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
408668|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408669|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
408670|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408671|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
408672|NCT00508157|E2|Reported Event|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
408673|NCT00508157|E1|Reported Event|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
408674|NCT00508274|B1|Baseline|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
408675|NCT00508274|P1|Participant Flow|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
408676|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
408677|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
408678|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
408679|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
408680|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
408681|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
408682|NCT00508274|E1|Reported Event|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
408683|NCT00508391|B3|Baseline|Total|Total of all reporting groups
408928|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408684|NCT00508391|B2|Baseline|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
410702|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
408686|NCT00508391|P2|Participant Flow|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
408687|NCT00508391|P1|Participant Flow|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
408688|NCT00508391|O3|Outcome|Total Subjects|Total subjects enrolled in study.
408689|NCT00508391|O2|Outcome|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
408690|NCT00508391|O1|Outcome|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
408691|NCT00508391|O3|Outcome|Total Subjects|Total subjects enrolled in study.
408692|NCT00508391|O2|Outcome|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
408693|NCT00508391|O1|Outcome|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
408694|NCT00508391|E3|Reported Event|Total Subjects|Total subjects enrolled in study.
408695|NCT00508391|E2|Reported Event|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
408696|NCT00508391|E1|Reported Event|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
408697|NCT00508404|B1|Baseline|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408698|NCT00508404|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408699|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408700|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408701|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408702|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408703|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408704|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408705|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408706|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408707|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408708|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408709|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408710|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408711|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408802|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408712|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
410703|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
408713|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408714|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408715|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408716|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408717|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408718|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408719|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408720|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408721|NCT00508404|E1|Reported Event|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
408722|NCT00508469|B3|Baseline|Total|Total of all reporting groups
408723|NCT00508469|B2|Baseline|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
408724|NCT00508469|B1|Baseline|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
408725|NCT00508469|P2|Participant Flow|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
408726|NCT00508469|P1|Participant Flow|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
408727|NCT00508469|O2|Outcome|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
408728|NCT00508469|O1|Outcome|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
408729|NCT00508469|E2|Reported Event|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
408730|NCT00508469|E1|Reported Event|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
408731|NCT00508482|B4|Baseline|Total|Total of all reporting groups
408732|NCT00508482|B3|Baseline|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408733|NCT00508482|B2|Baseline|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408734|NCT00508482|B1|Baseline|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408735|NCT00508482|P3|Participant Flow|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408736|NCT00508482|P2|Participant Flow|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408753|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408754|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408737|NCT00508482|P1|Participant Flow|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408738|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408739|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408740|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408741|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408742|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408743|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408744|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408745|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408746|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408747|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408748|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408749|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408750|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408751|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408752|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
409183|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
408755|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408756|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408757|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408758|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408759|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408760|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408761|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408762|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408763|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408764|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408765|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408766|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408767|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408768|NCT00508482|E3|Reported Event|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
408769|NCT00508482|E2|Reported Event|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
408800|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408801|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408803|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408770|NCT00508482|E1|Reported Event|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks."
408771|NCT00508521|B1|Baseline|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
408772|NCT00508521|P1|Participant Flow|FES and Motor Learning Training Group|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
408773|NCT00508521|O1|Outcome|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
408774|NCT00508521|E1|Reported Event|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
408775|NCT00508651|B3|Baseline|Total|Total of all reporting groups
408776|NCT00508651|B2|Baseline|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408777|NCT00508651|B1|Baseline|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408778|NCT00508651|P2|Participant Flow|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408779|NCT00508651|P1|Participant Flow|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408780|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408781|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408782|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408783|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408784|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408785|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408786|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408787|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408788|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408789|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408790|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408791|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408792|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408793|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408794|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408795|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408796|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408797|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408798|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408799|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
425907|NCT00542425|O5|Outcome|Teriparatide|
408804|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408805|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408806|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408807|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408808|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408809|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408810|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408811|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408812|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408813|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408814|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408815|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408816|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408817|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408818|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408819|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408820|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408821|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408822|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408823|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408824|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408825|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408826|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408827|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408828|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408829|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408830|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408831|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408832|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408927|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408833|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408834|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408835|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408836|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408837|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408838|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408839|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408840|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408841|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408842|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408843|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408844|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408845|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408846|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408847|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408848|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408849|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408850|NCT00508651|E2|Reported Event|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
408851|NCT00508651|E1|Reported Event|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
408852|NCT00508716|B3|Baseline|Total|Total of all reporting groups
408853|NCT00508716|B2|Baseline|Tailored Intervention for Patients With Low Health Literacy an|"Tailored Intervention for patients with low health literacy and nurse-directed teachback
Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
408854|NCT00508716|B1|Baseline|Usual Care|CHF Education by usual Nurse without teach-back or Video.
408855|NCT00508716|P2|Participant Flow|Tailored Low Health Literacy Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.
Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
408856|NCT00508716|P1|Participant Flow|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
408857|NCT00508716|O2|Outcome|Tailored Low Health Literacy Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.
Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
408858|NCT00508716|O1|Outcome|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
408889|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
425908|NCT00542425|O4|Outcome|BA058 80 µg|
408890|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
408859|NCT00508716|E2|Reported Event|Teilored Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.
Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
408860|NCT00508716|E1|Reported Event|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
408861|NCT00508742|B3|Baseline|Total|Total of all reporting groups
408862|NCT00508742|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
408863|NCT00508742|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
408864|NCT00508742|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
408865|NCT00508742|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
408866|NCT00508742|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
408867|NCT00508742|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
408868|NCT00508742|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
408869|NCT00508742|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
408870|NCT00508742|E8|Reported Event|After Toddler Dose 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
408871|NCT00508742|E7|Reported Event|After Toddler Dose 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
408872|NCT00508742|E6|Reported Event|Toddler Dose 7vPnC|Participants who received 7vPnC 0.5 mL dose intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.
408873|NCT00508742|E5|Reported Event|Toddler Dose 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.
408874|NCT00508742|E4|Reported Event|After Infant Series 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.
408875|NCT00508742|E3|Reported Event|After Infant Series 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.
408876|NCT00508742|E2|Reported Event|Infant Series 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.
408877|NCT00508742|E1|Reported Event|Infant Series 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.
408878|NCT00508755|B1|Baseline|Gait Training After Stroke|Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
408879|NCT00508755|P1|Participant Flow|Gait Training After Stroke|Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
408880|NCT00508755|O3|Outcome|Combined Gait Robot and FES|The 6 study subjects with chronic stroke ambulated with combination Gait Robot and FES, and observational gait analysis was performed.
408881|NCT00508755|O2|Outcome|FES-Alone|The 6 study subjects with chronic stroke ambulated with FES, and observational gait analysis was performed.
408882|NCT00508755|O1|Outcome|Gait Robot-alone Training|The 6 study subjects with chronic stroke ambulated in the Gait Robot, and observational gait analysis was performed.
408883|NCT00508755|E1|Reported Event|Gait Training After Stroke|subjects with Chronic stroke (.5-1.5 years post stroke)received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and Gait Robot.
408884|NCT00508820|B3|Baseline|Total|Total of all reporting groups
408885|NCT00508820|B2|Baseline|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
408886|NCT00508820|B1|Baseline|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
408887|NCT00508820|P2|Participant Flow|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
408888|NCT00508820|P1|Participant Flow|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
408926|NCT00509028|P1|Participant Flow|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408891|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
408892|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
408893|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
408894|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
408895|NCT00508820|E2|Reported Event|Romiplostim Cohort 2|
408896|NCT00508820|E1|Reported Event|Romiplostim Cohort 1|
408897|NCT00508872|B1|Baseline|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
408898|NCT00508872|P1|Participant Flow|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
408899|NCT00508872|O1|Outcome|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
408900|NCT00508872|E1|Reported Event|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
408901|NCT00508924|B5|Baseline|Total|Total of all reporting groups
408902|NCT00508924|B4|Baseline|Heparin|"70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
408903|NCT00508924|B3|Baseline|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408904|NCT00508924|B2|Baseline|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408905|NCT00508924|B1|Baseline|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408906|NCT00508924|P4|Participant Flow|Heparin|"70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
408907|NCT00508924|P3|Participant Flow|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408908|NCT00508924|P2|Participant Flow|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408909|NCT00508924|P1|Participant Flow|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408910|NCT00508924|O4|Outcome|Heparin|"70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
408911|NCT00508924|O3|Outcome|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408912|NCT00508924|O2|Outcome|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408913|NCT00508924|O1|Outcome|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408914|NCT00508924|O4|Outcome|Heparin|"70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
408915|NCT00508924|O3|Outcome|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408916|NCT00508924|O2|Outcome|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408917|NCT00508924|O1|Outcome|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408918|NCT00508924|E4|Reported Event|Heparin|"70-100 IU/kg i.v. bolus
additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
408919|NCT00508924|E3|Reported Event|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408920|NCT00508924|E2|Reported Event|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408921|NCT00508924|E1|Reported Event|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min
additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
408922|NCT00509028|B3|Baseline|Total|Total of all reporting groups
408923|NCT00509028|B2|Baseline|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408924|NCT00509028|B1|Baseline|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408925|NCT00509028|P2|Participant Flow|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
409232|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
408929|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
456455|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
408931|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408932|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408933|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408934|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408935|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408936|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408937|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408938|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408939|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408940|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408941|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408942|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408943|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408944|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408945|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408946|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408947|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408948|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408949|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408950|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408951|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408952|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408953|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408954|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408955|NCT00509028|E2|Reported Event|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
408956|NCT00509028|E1|Reported Event|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
408957|NCT00509041|B1|Baseline|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
408958|NCT00509041|P1|Participant Flow|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
408959|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
408960|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
408961|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
408962|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
408963|NCT00509041|E1|Reported Event|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
408964|NCT00509067|B3|Baseline|Total|Total of all reporting groups
408965|NCT00509067|B2|Baseline|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
408966|NCT00509067|B1|Baseline|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
408967|NCT00509067|P2|Participant Flow|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
408968|NCT00509067|P1|Participant Flow|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
408969|NCT00509067|O2|Outcome|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
408970|NCT00509067|O1|Outcome|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
408971|NCT00509067|E2|Reported Event|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
408972|NCT00509067|E1|Reported Event|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
409114|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409187|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
409188|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
408973|NCT00502671|B1|Baseline|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
408974|NCT00502671|P1|Participant Flow|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine orally (PO) as 1250 milligrams per meter-squared (mg/m^2) twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
408975|NCT00502671|O1|Outcome|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
408976|NCT00502671|O1|Outcome|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
408977|NCT00502671|E1|Reported Event|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
408978|NCT00502697|B3|Baseline|Total|Total of all reporting groups
408979|NCT00502697|B2|Baseline|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
408980|NCT00502697|B1|Baseline|Treatment Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
408981|NCT00502697|P2|Participant Flow|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Conventional prenatal and postpartum clinic care : Women in this group received conventional prenatal care and postpartum clinic care."
408982|NCT00502697|P1|Participant Flow|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
408983|NCT00502697|O2|Outcome|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
408984|NCT00502697|O1|Outcome|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
408985|NCT00502697|O2|Outcome|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
408986|NCT00502697|O1|Outcome|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
408987|NCT00502697|E2|Reported Event|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
409184|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
409233|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
408988|NCT00502697|E1|Reported Event|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
408989|NCT00502775|B4|Baseline|Total|Total of all reporting groups
408990|NCT00502775|B3|Baseline|Fexofenadine 180 mg|
408991|NCT00502775|B2|Baseline|Fluticasone Furoate 110mcg|
408992|NCT00502775|B1|Baseline|Placebo|
408993|NCT00502775|P3|Participant Flow|Fexofenadine 180 mg|
408994|NCT00502775|P2|Participant Flow|Fluticasone Furoate 110mcg|
408995|NCT00502775|P1|Participant Flow|Placebo|
408996|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
408997|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
408998|NCT00502775|O1|Outcome|Placebo|
408999|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
409000|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
409001|NCT00502775|O1|Outcome|Placebo|
409002|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
409003|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
409004|NCT00502775|O1|Outcome|Placebo|
409005|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
409006|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
409007|NCT00502775|O1|Outcome|Placebo|
409008|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
409009|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
409010|NCT00502775|O1|Outcome|Placebo|
409011|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
409012|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
409013|NCT00502775|O1|Outcome|Placebo|
409014|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
409015|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
409016|NCT00502775|O1|Outcome|Placebo|
409017|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
409018|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
409019|NCT00502775|O1|Outcome|Placebo|
409020|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
409021|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
409022|NCT00502775|O1|Outcome|Placebo|
409023|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
409024|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
409025|NCT00502775|O1|Outcome|Placebo|
409026|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
409027|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
409028|NCT00502775|O1|Outcome|Placebo|
409029|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
409030|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
409031|NCT00502775|O1|Outcome|Placebo|
409032|NCT00502775|E3|Reported Event|Fexofenadine 180 mg|
409033|NCT00502775|E2|Reported Event|Fluticasone Furoate 110mcg|
409034|NCT00502775|E1|Reported Event|Placebo|
409035|NCT00502801|B1|Baseline|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
409036|NCT00502801|P1|Participant Flow|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
409037|NCT00502801|O1|Outcome|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
409038|NCT00502801|O1|Outcome|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
409039|NCT00502801|E1|Reported Event|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
409040|NCT00502840|B1|Baseline|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.
409041|NCT00502840|P1|Participant Flow|Rituximab Plus Methotrexate (MTX)|Participants received rituximab 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 milligrams (mg) weekly; participants may also have been receiving a stable dose of folic acid. Participants with Disease Activity Score Based on 28 Joint Count (DAS28) greater than or equal to (≥)2.6 and an improvement in DAS28 greater than (>0.6) 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.
409042|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409043|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409185|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
409186|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
409044|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409045|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409046|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409047|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409048|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409049|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409050|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409051|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409052|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409053|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409054|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409055|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409056|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409234|NCT00509197|E2|Reported Event|Placebo|Treatment with placebo
409057|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409058|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409059|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409060|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409061|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409062|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409063|NCT00502840|O1|Outcome|Rituximab Pluse MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409064|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409065|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409066|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409067|NCT00502840|E1|Reported Event|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
409068|NCT00502853|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409069|NCT00502853|P1|Participant Flow|Rituximab Plus (+) Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg per week (mg/week) by mouth or parenterally. Nonresponsive participants (defined as Disease Activity Score Based on 28-Joint Count and C-Reactive Protein [DAS28-CRP] score of greater than [>]2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409225|NCT00509197|P1|Participant Flow|Fluticasone 500 mcg Bid|Treatment with Inhaled Corticosteroids
409070|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409071|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409072|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received 1000 mg of Rituximab by IV infusion on Days 1 and 15 (considered to be one cycle). Participants also received 10-25 mg/week stable concomitant MTX by mouth or parenterally. Additional cycles of 2 infusions each could be administered provided the following: a minimum of 24 weeks had passed since the first infusion of the last course of study medication; the participant had a DAS28-CRP score of >2.6; the participant had a neutrophil count not below 1.5x10^3/μL; there was an absence of significant cardiac or pulmonary disease, primary or secondary immunodeficiency, and infections.
409073|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409074|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409075|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409076|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409077|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409078|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409079|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409080|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409081|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409082|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409083|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409084|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409115|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409085|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409086|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409087|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409088|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409089|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409090|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409091|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409092|NCT00502853|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
409093|NCT00502905|B1|Baseline|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
409094|NCT00502905|P1|Participant Flow|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
409095|NCT00502905|O1|Outcome|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
409096|NCT00502905|E1|Reported Event|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
409097|NCT00502944|B3|Baseline|Total|Total of all reporting groups
409098|NCT00502944|B2|Baseline|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
409099|NCT00502944|B1|Baseline|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
409100|NCT00502944|P2|Participant Flow|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
409101|NCT00502944|P1|Participant Flow|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
409102|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
409103|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
409104|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
409105|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
409106|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
409107|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
409108|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
409109|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
409110|NCT00502944|E2|Reported Event|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
409111|NCT00502944|E1|Reported Event|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
409112|NCT00502996|B1|Baseline|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409113|NCT00502996|P1|Participant Flow|Rituximab|Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 milligram (mg) IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409116|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409117|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409118|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409119|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409120|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409121|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409122|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409123|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409124|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409125|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409126|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409127|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409128|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409129|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409130|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409131|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409132|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409133|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409134|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409135|NCT00502996|E1|Reported Event|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
409136|NCT00503009|B4|Baseline|Total|Total of all reporting groups
409137|NCT00503009|B3|Baseline|Placebo Diskus BID|Placebo twice daily
409138|NCT00503009|B2|Baseline|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
409139|NCT00503009|B1|Baseline|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
409140|NCT00503009|P3|Participant Flow|Placebo Diskus BID|Placebo twice daily
409141|NCT00503009|P2|Participant Flow|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
409142|NCT00503009|P1|Participant Flow|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
409143|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
409144|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
409145|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
409146|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
409147|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
409148|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
409149|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
409150|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
409151|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
409152|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
409153|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
409154|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
409155|NCT00503009|E3|Reported Event|Placebo Diskus BID|Placebo twice daily
409156|NCT00503009|E2|Reported Event|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
409157|NCT00503009|E1|Reported Event|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
409158|NCT00503113|B4|Baseline|Total|Total of all reporting groups
409159|NCT00503113|B3|Baseline|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
409160|NCT00503113|B2|Baseline|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
409161|NCT00503113|B1|Baseline|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
409162|NCT00503113|P3|Participant Flow|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
409163|NCT00503113|P2|Participant Flow|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
409164|NCT00503113|P1|Participant Flow|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
409165|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
409166|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
409167|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
409168|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
409169|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
409170|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
409171|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
409172|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
409173|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
409174|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
409175|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
409176|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
409177|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
409178|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
409179|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
409180|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
409181|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
409182|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
409189|NCT00503113|E3|Reported Event|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
409190|NCT00503113|E2|Reported Event|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
409191|NCT00503113|E1|Reported Event|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
409192|NCT00503139|B1|Baseline|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
409193|NCT00503139|P1|Participant Flow|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
409194|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
409195|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
409196|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
409197|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
409198|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
409199|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
409200|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
409201|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
409202|NCT00503139|E1|Reported Event|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
409203|NCT00503308|B3|Baseline|Total|Total of all reporting groups
409204|NCT00503308|B2|Baseline|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
409205|NCT00503308|B1|Baseline|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
409206|NCT00503308|P2|Participant Flow|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
409207|NCT00503308|P1|Participant Flow|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
409208|NCT00503308|O2|Outcome|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
409209|NCT00503308|O1|Outcome|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
409210|NCT00503308|E2|Reported Event|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
409211|NCT00503308|E1|Reported Event|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
409212|NCT00509106|B3|Baseline|Total|Total of all reporting groups
409213|NCT00509106|B2|Baseline|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
409214|NCT00509106|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
409215|NCT00509106|P2|Participant Flow|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
409216|NCT00509106|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
409217|NCT00509106|O2|Outcome|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
409218|NCT00509106|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
409219|NCT00509106|E2|Reported Event|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
409220|NCT00509106|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
409221|NCT00509197|B3|Baseline|Total|Total of all reporting groups
409222|NCT00509197|B2|Baseline|Placebo|Treatment with placebo
409223|NCT00509197|B1|Baseline|Fluticasone 500 mcg Bid|Treatment with inhaled corticosteroids
409224|NCT00509197|P2|Participant Flow|Placebo|treatment with placebo
409235|NCT00509197|E1|Reported Event|Fluticasone 500 mcg Bid|Treatment with inhaled Corticosteroids
409236|NCT00509223|B3|Baseline|Total|Total of all reporting groups
409237|NCT00509223|B2|Baseline|Lifestyle Counseling|
409238|NCT00509223|B1|Baseline|Lifestyle Counseling With PAP Therapy|
409239|NCT00509223|P2|Participant Flow|Group 2|"Lifestyle counseling without Positive Airway Pressure (PAP) therapy
Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations."
409240|NCT00509223|P1|Participant Flow|Group 1|"Lifestyle counseling with Positive Airway Pressure (PAP) therapy
Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.
Positive Airway Pressure therapy : PAP therapy was initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep."
409241|NCT00509223|O2|Outcome|Lifestyle Counseling|
409242|NCT00509223|O1|Outcome|Lifestyle Counseling With PAP Therapy|
409243|NCT00509223|E2|Reported Event|Lifestyle Counseling With PAP Therapy|
409244|NCT00509223|E1|Reported Event|Lifestyle Counseling|
409245|NCT00509236|B3|Baseline|Total|Total of all reporting groups
409246|NCT00509236|B2|Baseline|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
409247|NCT00509236|B1|Baseline|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
409248|NCT00509236|P2|Participant Flow|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
409249|NCT00509236|P1|Participant Flow|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
409250|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
409251|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
409252|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
409253|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
409254|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
409255|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
409256|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
409257|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
409258|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
409259|NCT00509236|E2|Reported Event|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
409260|NCT00509236|E1|Reported Event|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
409261|NCT00509249|B1|Baseline|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
409262|NCT00509249|P1|Participant Flow|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
409263|NCT00509249|O1|Outcome|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
409264|NCT00509249|E1|Reported Event|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
409265|NCT00509262|B3|Baseline|Total|Total of all reporting groups
409266|NCT00509262|B2|Baseline|Glipizide|Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
409267|NCT00509262|B1|Baseline|Sitagliptin|Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
409268|NCT00509262|P2|Participant Flow|Glipizide|Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
409269|NCT00509262|P1|Participant Flow|Sitagliptin|Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
409270|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
409271|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
409272|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
409273|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
409274|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
409275|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
409276|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
409277|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
409278|NCT00509262|E2|Reported Event|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
409279|NCT00509262|E1|Reported Event|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
409280|NCT00509288|B3|Baseline|Total|Total of all reporting groups
409281|NCT00509288|B2|Baseline|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
409282|NCT00509288|B1|Baseline|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
409466|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID, Smokers|
409307|NCT00509366|E4|Reported Event|Cisplatin Resistant (Post-Amendment)|Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
410704|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
409283|NCT00509288|P2|Participant Flow|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL). A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL. Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr. Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion.
409284|NCT00509288|P1|Participant Flow|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL). A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL. Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr. Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days. Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion.
409285|NCT00509288|O2|Outcome|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
409286|NCT00509288|O1|Outcome|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
409287|NCT00509288|O2|Outcome|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
409288|NCT00509288|O1|Outcome|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
409289|NCT00509288|E2|Reported Event|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
409290|NCT00509288|E1|Reported Event|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
409291|NCT00509366|B6|Baseline|Total|Total of all reporting groups
409292|NCT00509366|B5|Baseline|Screen Failure|Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis or those who were assigned treatment but not treated after reevaluation of their eligibility.
409293|NCT00509366|B4|Baseline|Docetaxel + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study, assigned to docetaxel/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
409294|NCT00509366|B3|Baseline|Pemetrexed + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study, assigned to cisplatin/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
409295|NCT00509366|B2|Baseline|Cisplatin + Pemetrexed|Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/pemetrexed protocol-based treatment consistent with histology, and treated during the course of the study.
409296|NCT00509366|B1|Baseline|Cisplatin + Gemcitabine|Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/gemcitabine protocol-based treatment consistent with histology, and treated during the course of the study.
409297|NCT00509366|P5|Participant Flow|Screen Failure|Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis. Nine patients did not undergo biopsy. Eight experienced complications from biopsy. The remaining 34 were deemed ineligible after genomic screening. Note that three patients who were assigned protocol-based treatment (2 in the cisplatin sensitive group and 1 in the cisplatin resistant group) did not receive the treatment and were added to the 51 initially identified as screen failures within the summary of baseline characteristics and outcome measures.
409298|NCT00509366|P4|Participant Flow|Docetaxel + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study and assigned to docetaxel+ gemcitabine protocol-based treatment consistent with histology.
409299|NCT00509366|P3|Participant Flow|Pemetrexed + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study and assigned to pemetrexed + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm was later deemed ineligible before initiating protocol treatment and was classified as a screen failure.
409300|NCT00509366|P2|Participant Flow|Cisplatin + Pemetrexed|Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + pemetrexed protocol-based treatment consistent with histology. One patient who was assigned to this arm was deemed ineligible due to the discover of brain metastasis. This patient did not receive protocol treatment and was classified as a screen failure.
409301|NCT00509366|P1|Participant Flow|Cisplatin + Gemcitabine|Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm withdrew from the study. This patient did not receive protocol treatment and was classified as a screen failure.
409302|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study.
409303|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive (cisplatin/pemetrexed or cisplatin/gemcitabine) and resistant (pemetrexed/gemcitabine or docetaxel/gemcitabine) arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
409304|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
409305|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
409306|NCT00509366|E5|Reported Event|Screen Failure|Screen failures constitute patients who were registered into the study and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not enrolled to genomics-directed, protocol-based therapy. From the participant flow, 9 of the 54 screen failures did not have adverse event follow-up, resulting in a final count of 45 screen failures with adverse event follow-up.
409308|NCT00509366|E3|Reported Event|Cisplatin Resistant (Pre-Amendment)|Pre-amendment cisplatin resistant refers to patients who experienced adverse events and treated with cisplatin-resistant protocol based therapy per the amendment dated 1/25/2010.
409309|NCT00509366|E2|Reported Event|Cisplatin Sensitive (Post-Amendment)|Post-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
409310|NCT00509366|E1|Reported Event|Cisplatin Sensitive (Pre-Amendment)|Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated 1/25/2010.
409311|NCT00509392|B3|Baseline|Total|Total of all reporting groups
409312|NCT00509392|B2|Baseline|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409313|NCT00509392|B1|Baseline|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409314|NCT00509392|P3|Participant Flow|RF / EVLA|Bilateral treatment where one limb is treated with RFA and the contralateral limb is treated with EVL
409315|NCT00509392|P2|Participant Flow|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409316|NCT00509392|P1|Participant Flow|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409317|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409318|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409319|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409320|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409321|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409322|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409323|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409324|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409325|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409326|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409327|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409328|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409329|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409330|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409331|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409332|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409333|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409334|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409335|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409336|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409337|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409338|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409339|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409340|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409341|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409342|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409343|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409344|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409345|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409346|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409347|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409467|NCT00510276|O4|Outcome|Placebo Non-smokers|
409468|NCT00510276|O3|Outcome|Placebo, Smokers|
409348|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
456456|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
409349|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409350|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409351|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409352|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409353|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409354|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409355|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409356|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409357|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409358|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409359|NCT00509392|E2|Reported Event|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
409360|NCT00509392|E1|Reported Event|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
409361|NCT00510146|B3|Baseline|Total|Total of all reporting groups
409362|NCT00510146|B2|Baseline|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409363|NCT00510146|B1|Baseline|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409364|NCT00510146|P2|Participant Flow|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409365|NCT00510146|P1|Participant Flow|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409366|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409367|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409368|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409369|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409370|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409371|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409372|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409476|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409477|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409373|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409374|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409375|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409376|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409377|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409378|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409379|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409380|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409381|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409382|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409383|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409384|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409385|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409469|NCT00510276|O2|Outcome|Atomoxetine 20 - 50 mg BID, Non-smokers|
409470|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID, Smokers|
409471|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409386|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409387|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
409388|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409389|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409390|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409391|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409392|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409393|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409394|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409395|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409396|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409397|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409398|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409399|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409400|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409401|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409402|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409403|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409404|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409405|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409406|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409407|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409408|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409472|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409473|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409409|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409410|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409411|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409412|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409413|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409414|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409415|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409416|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409417|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409418|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409419|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409420|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409421|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409422|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409423|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409424|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409425|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409426|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409427|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409428|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409429|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409430|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409431|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409432|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409474|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409475|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409433|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409434|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409435|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409436|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409437|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409438|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409439|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409440|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409441|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409442|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409443|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409444|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409445|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409446|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409447|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
409448|NCT00510146|E3|Reported Event|Olanzapine (Open Label Treatment Period|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Visit 9. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Visit 10. Those on higher doses will be reduced between Visit 9 and 10 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at visit 10; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at visit 10). Dose increases beyond visit 10 are permitted and at the investigator's discretion.
409449|NCT00510146|E2|Reported Event|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
409450|NCT00510146|E1|Reported Event|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg. which is increased to 10 mg. per day no later than 3-7 days after Visit 2. Subsequent dose increases above 10 mg. (up to a maximum of 20 mg per day) are permitted in 5 mg. per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg. requires study discontinuation.
409451|NCT00510224|B1|Baseline|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
409452|NCT00510224|P1|Participant Flow|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
409453|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
409454|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
409455|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
409456|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
409457|NCT00510224|E1|Reported Event|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
409458|NCT00510276|B3|Baseline|Total|Total of all reporting groups
409459|NCT00510276|B2|Baseline|Placebo|twice a day for 12 weeks
409460|NCT00510276|B1|Baseline|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409461|NCT00510276|P2|Participant Flow|Placebo|twice a day for 12 weeks
409462|NCT00510276|P1|Participant Flow|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409463|NCT00510276|O4|Outcome|Placebo, Non-Smokers|
409464|NCT00510276|O3|Outcome|Placebo, Smokers|
409465|NCT00510276|O2|Outcome|Atomoxetine 20 - 50 mg BID, Non-Smokers|
409478|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409479|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409480|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409481|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409482|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409483|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409484|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409485|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409486|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409487|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409488|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409489|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409490|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409491|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409492|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409493|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409494|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409495|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409496|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409497|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409498|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409499|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409500|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409501|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409502|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409503|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409504|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409505|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409506|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409507|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409508|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409509|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409510|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409511|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409512|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409513|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409514|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409515|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409516|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409517|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409518|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409519|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409520|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409521|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409522|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409523|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID and Placebo|
409524|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409525|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409526|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409527|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409528|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409529|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409530|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409531|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409532|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409533|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409534|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409535|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409536|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409537|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409538|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409539|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409540|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409541|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409542|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
409543|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409544|NCT00510276|E2|Reported Event|Placebo|twice a day for 12 weeks
409545|NCT00510276|E1|Reported Event|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
409546|NCT00510289|B1|Baseline|All Patients|All patients who signed consent
409547|NCT00510289|P1|Participant Flow|All Patients|All patients who signed consent
409548|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
409549|NCT00510289|O1|Outcome|Evaluable Patients|Patients who received at least one cycle of study drug and underwent bone marrow assessments
409550|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
409551|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
409552|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
409553|NCT00510289|E1|Reported Event|All Patients|SAEs are listed for all patients who took at least one dose of study drug. Due to early study closure and patient withdrawals, Other AEs are listed for 9 patients only.
409554|NCT00510484|B3|Baseline|Total|Total of all reporting groups
409555|NCT00510484|B2|Baseline|Pancrelipase/Placebo|
409556|NCT00510484|B1|Baseline|Placebo/Pancrelipase|
409557|NCT00510484|P2|Participant Flow|Pancrelipase/Placebo|
409558|NCT00510484|P1|Participant Flow|Placebo/Pancrelipase|
409559|NCT00510484|O2|Outcome|Placebo|
409560|NCT00510484|O1|Outcome|Pancrelipase|
409561|NCT00510484|O2|Outcome|Placebo|
409562|NCT00510484|O1|Outcome|Pancrelipase|
409563|NCT00510484|O2|Outcome|Placebo|
409564|NCT00510484|O1|Outcome|Pancrelipase|
409565|NCT00510484|O2|Outcome|Placebo|
409566|NCT00510484|O1|Outcome|Pancrelipase|
409567|NCT00510484|O2|Outcome|Placebo|
409568|NCT00510484|O1|Outcome|Pancrelipase|
409569|NCT00510484|O2|Outcome|Placebo|
409570|NCT00510484|O1|Outcome|Pancrelipase|
409571|NCT00510484|O2|Outcome|Placebo|
409572|NCT00510484|O1|Outcome|Pancrelipase|
409573|NCT00510484|O2|Outcome|Placebo|
409574|NCT00510484|O1|Outcome|Pancrelipase|
409575|NCT00510484|E2|Reported Event|Placebo|
409576|NCT00510484|E1|Reported Event|Pancrelipase|
409577|NCT00510497|B1|Baseline|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine
Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
409578|NCT00510497|P1|Participant Flow|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine
Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
409579|NCT00510497|O1|Outcome|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine
Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
409580|NCT00510497|O1|Outcome|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine
Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
409581|NCT00510497|E1|Reported Event|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine (does not include one enrolled participant who received no study treatment)
Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
409582|NCT00510510|B4|Baseline|Total|Total of all reporting groups
409583|NCT00510510|B3|Baseline|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
409584|NCT00510510|B2|Baseline|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
409585|NCT00510510|B1|Baseline|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
409586|NCT00510510|P3|Participant Flow|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
409587|NCT00510510|P2|Participant Flow|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
409588|NCT00510510|P1|Participant Flow|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
409589|NCT00510510|O3|Outcome|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
409590|NCT00510510|O2|Outcome|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
409591|NCT00510510|O1|Outcome|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
409592|NCT00510510|O3|Outcome|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
409593|NCT00510510|O2|Outcome|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
409594|NCT00510510|O1|Outcome|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
409595|NCT00510510|E3|Reported Event|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
409596|NCT00510510|E2|Reported Event|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
409597|NCT00510510|E1|Reported Event|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
409598|NCT00510653|B1|Baseline|Imatinib Mesylate|600 mg/day orally for 6 Weeks
409599|NCT00510653|P1|Participant Flow|Imatinib Mesylate|600 mg/day orally for 6 Weeks
409600|NCT00510653|O1|Outcome|Imatinib Mesylate|600 mg/day orally for 6 Weeks
409601|NCT00510653|E1|Reported Event|Imatinib Mesylate|600 mg/day orally for 6 Weeks
409603|NCT00510692|B2|Baseline|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409604|NCT00510692|B1|Baseline|2g/Day EPA|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409605|NCT00510692|P2|Participant Flow|Placebo|Medium chain triglycerides 2 g per day for six months.
409606|NCT00510692|P1|Participant Flow|2g/Day Eicosapentaenoic Acid (EPA)|Eicosapentaenoic Acid (EPA) 2g per day for six months
409607|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409608|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409609|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409610|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409611|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409612|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409613|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409614|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409615|NCT00510692|O2|Outcome|Placebo|Medium chain triglycerides 2g per day for six months
409616|NCT00510692|O1|Outcome|2g/Day Eicosapentaenoic Acid (EPA)|Eicosapentaenoic Acid (EPA) 2g per day for six months
409617|NCT00510692|E2|Reported Event|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409618|NCT00510692|E1|Reported Event|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months
Endoscopy: With video and photographs at baseline and month 6.
Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
409619|NCT00510744|B1|Baseline|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%
pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
409620|NCT00510744|P1|Participant Flow|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%
pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
409783|NCT00510952|B3|Baseline|Total|Total of all reporting groups
409784|NCT00510952|B2|Baseline|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409621|NCT00510744|O1|Outcome|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%
The ability of pancreatic enzyme supplement: 4 caps with meals, 2 with snacks to improve fat absorption"
409622|NCT00510744|E1|Reported Event|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%
pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
409623|NCT00510783|B3|Baseline|Total|Total of all reporting groups
409624|NCT00510783|B2|Baseline|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
409625|NCT00510783|B1|Baseline|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
409626|NCT00510783|P2|Participant Flow|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
409627|NCT00510783|P1|Participant Flow|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
409628|NCT00510783|O2|Outcome|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
409629|NCT00510783|O1|Outcome|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
409630|NCT00510783|E2|Reported Event|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
409631|NCT00510783|E1|Reported Event|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
409632|NCT00510809|B4|Baseline|Total|Total of all reporting groups
409633|NCT00510809|B3|Baseline|Policosanol|20 mg daily, open label
409634|NCT00510809|B2|Baseline|Statin and Placebo|20mg daily, double-blind
409635|NCT00510809|B1|Baseline|Statin and Policosanol|20mg daily, double-blind
409636|NCT00510809|P3|Participant Flow|Policosanol|20 mg daily, open label
409637|NCT00510809|P2|Participant Flow|Statin and Placebo|20mg daily, double-blind
409638|NCT00510809|P1|Participant Flow|Statin and Policosanol|20mg daily, double-blind
409639|NCT00510809|O3|Outcome|Policosanol|20 mg daily, open label
409640|NCT00510809|O2|Outcome|Statin and Placebo|20mg daily, double-blind
409641|NCT00510809|O1|Outcome|Statin and Policosanol|20mg daily, double-blind
409642|NCT00510809|O3|Outcome|Policosanol|20 mg daily, open label
409643|NCT00510809|O2|Outcome|Statin and Placebo|20mg daily, double-blind
409644|NCT00510809|O1|Outcome|Statin and Policosanol|20mg daily, double-blind
409645|NCT00510809|E3|Reported Event|Policosanol|20 mg daily, open label
409646|NCT00510809|E2|Reported Event|Statin and Placebo|20mg daily, double-blind
409647|NCT00510809|E1|Reported Event|Statin and Policosanol|20mg daily, double-blind
409648|NCT00510835|B4|Baseline|Total|Total of all reporting groups
409649|NCT00510835|B3|Baseline|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.
Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
409650|NCT00510835|B2|Baseline|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.
Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
409651|NCT00510835|B1|Baseline|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.
Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
409652|NCT00510835|P3|Participant Flow|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.
Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
409653|NCT00510835|P2|Participant Flow|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.
Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
409785|NCT00510952|B1|Baseline|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409786|NCT00510952|P2|Participant Flow|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409787|NCT00510952|P1|Participant Flow|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
456457|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
409654|NCT00510835|P1|Participant Flow|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.
Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
409655|NCT00510835|O3|Outcome|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.
Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
409656|NCT00510835|O2|Outcome|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.
Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
409657|NCT00510835|O1|Outcome|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.
Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
409658|NCT00510835|E3|Reported Event|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.
Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
409659|NCT00510835|E2|Reported Event|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.
Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
409660|NCT00510835|E1|Reported Event|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.
Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
409661|NCT00510874|B8|Baseline|Total|Total of all reporting groups
409662|NCT00510874|B7|Baseline|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409663|NCT00510874|B6|Baseline|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409664|NCT00510874|B5|Baseline|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409665|NCT00510874|B4|Baseline|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409666|NCT00510874|B3|Baseline|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409667|NCT00510874|B2|Baseline|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409668|NCT00510874|B1|Baseline|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409669|NCT00510874|P7|Participant Flow|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
425909|NCT00542425|O3|Outcome|BA058 40 µg|
409670|NCT00510874|P6|Participant Flow|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409671|NCT00510874|P5|Participant Flow|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409672|NCT00510874|P4|Participant Flow|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409673|NCT00510874|P3|Participant Flow|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409674|NCT00510874|P2|Participant Flow|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409675|NCT00510874|P1|Participant Flow|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409676|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409677|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409678|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409679|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409680|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409681|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409682|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409683|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409684|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409685|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409686|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409687|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409688|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409689|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409690|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409691|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409692|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409693|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409694|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409695|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409696|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409697|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409698|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409699|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409700|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409701|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409702|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409703|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409704|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409705|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409706|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409707|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409708|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409709|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409710|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409711|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409712|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409713|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409714|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409715|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409716|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409717|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409718|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409719|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409720|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409721|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409722|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409723|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409724|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409725|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409726|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409727|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409728|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409729|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409730|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409731|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409732|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409733|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409734|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409735|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409736|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409737|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409738|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409739|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409740|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409741|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409742|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409743|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409744|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409745|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409746|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409747|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409748|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409749|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409750|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409751|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409752|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409753|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409754|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409755|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409756|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409757|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409758|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409759|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409760|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409761|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409762|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409763|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409764|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409765|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409766|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409767|NCT00510874|E7|Reported Event|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409768|NCT00510874|E6|Reported Event|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409769|NCT00510874|E5|Reported Event|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409770|NCT00510874|E4|Reported Event|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409771|NCT00510874|E3|Reported Event|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409772|NCT00510874|E2|Reported Event|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409773|NCT00510874|E1|Reported Event|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
409774|NCT00510887|B1|Baseline|VR-FND|"Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.
Each cycle will be repeated every 28 days for 8 cycles maximum.
Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Rituximab: Rituximab 375 mg/m2 IV on day 1
Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3
Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2
Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
409775|NCT00510887|P1|Participant Flow|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.
Each cycle will be repeated every 28 days for 8 cycles maximum.
Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Rituximab: Rituximab 375 mg/m2 IV on day 1
Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3
Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2
Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
409776|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.
Each cycle will be repeated every 28 days for 8 cycles maximum.
Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Rituximab: Rituximab 375 mg/m2 IV on day 1
Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3
Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2
Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
409777|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.
Each cycle will be repeated every 28 days for 8 cycles maximum.
Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Rituximab: Rituximab 375 mg/m2 IV on day 1
Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3
Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2
Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
409778|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.
Each cycle will be repeated every 28 days for 8 cycles maximum.
Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Rituximab: Rituximab 375 mg/m2 IV on day 1
Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3
Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2
Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
409779|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.
Each cycle will be repeated every 28 days for 8 cycles maximum.
Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Rituximab: Rituximab 375 mg/m2 IV on day 1
Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3
Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2
Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
409780|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.
Each cycle will be repeated every 28 days for 8 cycles maximum.
Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Rituximab: Rituximab 375 mg/m2 IV on day 1
Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3
Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2
Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
409781|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.
Each cycle will be repeated every 28 days for 8 cycles maximum.
Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Rituximab: Rituximab 375 mg/m2 IV on day 1
Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3
Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2
Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
409782|NCT00510887|E1|Reported Event|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.
Each cycle will be repeated every 28 days for 8 cycles maximum.
Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Rituximab: Rituximab 375 mg/m2 IV on day 1
Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3
Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2
Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
409788|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409789|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409790|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409791|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409792|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409793|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409794|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409795|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409796|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409797|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409798|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409799|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409800|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409801|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409802|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409803|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409804|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409805|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409806|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409807|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409808|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409809|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409810|NCT00510952|E2|Reported Event|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
409811|NCT00510952|E1|Reported Event|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
409812|NCT00511004|B4|Baseline|Total|Total of all reporting groups
409813|NCT00511004|B3|Baseline|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
409814|NCT00511004|B2|Baseline|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
409815|NCT00511004|B1|Baseline|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
409816|NCT00511004|P3|Participant Flow|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
409817|NCT00511004|P2|Participant Flow|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
409818|NCT00511004|P1|Participant Flow|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
409819|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
409820|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
409821|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
409822|NCT00511004|O3|Outcome|Diethylcarbamazine/Albendazole-HD2|"High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)
Albendazole: Comparing 400 mg to 800 mg dose
Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
409823|NCT00511004|O2|Outcome|Diethylcarbamazine/Albendazole- HD1|"High dose of DEC (300mg) and albendazole (800mg) yearly
Albendazole: Comparing 400 mg to 800 mg dose
Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
409824|NCT00511004|O1|Outcome|Diethylcarbamazine/Albendazole -STD|"Standard therapy of diethylcarbamazine (DEC) (300mg) and albendazole (400mg) yearly
Albendazole: Comparing 400 mg to 800 mg dose
Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
409825|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
409826|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
425910|NCT00542425|O2|Outcome|BA058 20 µg|
409827|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
409828|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
409829|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
409830|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
409831|NCT00511004|E3|Reported Event|High Dose Semiannual DEC/AC=LB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
409832|NCT00511004|E2|Reported Event|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
409833|NCT00511004|E1|Reported Event|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
409834|NCT00511095|B1|Baseline|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
409835|NCT00511095|P1|Participant Flow|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
409836|NCT00511095|O1|Outcome|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
409837|NCT00511095|O1|Outcome|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
409838|NCT00511095|O1|Outcome|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
409839|NCT00511095|E1|Reported Event|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
409840|NCT00511108|B5|Baseline|Total|Total of all reporting groups
409841|NCT00511108|B4|Baseline|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409842|NCT00511108|B3|Baseline|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
409843|NCT00511108|B2|Baseline|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
409844|NCT00511108|B1|Baseline|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409845|NCT00511108|P4|Participant Flow|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409846|NCT00511108|P3|Participant Flow|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
409847|NCT00511108|P2|Participant Flow|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
409848|NCT00511108|P1|Participant Flow|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409849|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409850|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
409851|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
409852|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409853|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409854|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
409855|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
409856|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409857|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409858|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
409859|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
409860|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409861|NCT00511108|E4|Reported Event|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409862|NCT00511108|E3|Reported Event|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
409863|NCT00511108|E2|Reported Event|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
409864|NCT00511108|E1|Reported Event|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
409865|NCT00511134|B3|Baseline|Total|Total of all reporting groups
409866|NCT00511134|B2|Baseline|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
409867|NCT00511134|B1|Baseline|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
409868|NCT00511134|P2|Participant Flow|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
409869|NCT00511134|P1|Participant Flow|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
409870|NCT00511134|O2|Outcome|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
409871|NCT00511134|O1|Outcome|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
409872|NCT00511134|O2|Outcome|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
409873|NCT00511134|O1|Outcome|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
409874|NCT00511134|E2|Reported Event|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
409875|NCT00511134|E1|Reported Event|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
409876|NCT00511147|B1|Baseline|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin
IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
409877|NCT00511147|P1|Participant Flow|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin
IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
409878|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin
IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
409879|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin
IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
409880|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin
IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
409881|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin
IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
409882|NCT00511147|E1|Reported Event|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin
IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
409883|NCT00511173|B1|Baseline|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
409884|NCT00511173|P1|Participant Flow|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
409885|NCT00511173|O2|Outcome|Pharmacist Dosing|Warfarin dose based on clinician dosing
409886|NCT00511173|O1|Outcome|Algorithm Dosing|Warfarin dose based on algorithm by Sconce, et al.
409887|NCT00511173|E1|Reported Event|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
409888|NCT00511199|B3|Baseline|Total|Total of all reporting groups
409889|NCT00511199|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
409890|NCT00511199|B1|Baseline|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409891|NCT00511199|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
409892|NCT00511199|P1|Participant Flow|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409893|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
409894|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409895|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
409896|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409897|NCT00511199|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
409898|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
409899|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
410693|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410345|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
409900|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409901|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
409902|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409903|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
409904|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409905|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
409906|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409907|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
409908|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409909|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
409910|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409911|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
409912|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409913|NCT00511199|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
409914|NCT00511199|E1|Reported Event|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
409915|NCT00511238|B3|Baseline|Total|Total of all reporting groups
409916|NCT00511238|B2|Baseline|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
409917|NCT00511238|B1|Baseline|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle
409918|NCT00511238|P2|Participant Flow|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
409919|NCT00511238|P1|Participant Flow|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles
409920|NCT00511238|O2|Outcome|Carfilzomib (A1) - Response-evaluable Population|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
Response-Evaluable Population(the primary analysis population) was defined as all patients who
had measurable disease at Baseline by either M-protein (serum and/or urine) or by quantitative serum Ig for certain patients with IgA myeloma
received at least 1 dose of carfilzomib
underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or patients who discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib—irrespective of availability of baseline and post-baseline assessment"
409942|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409921|NCT00511238|O1|Outcome|Carfilzomib (A1) - Safety Population|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
Safety population: The safety population was used for the analysis of safety data in this study. The safety population consists of all enrolled patients who received at least 1 dose of carfilzomib. However, for some safety analyses, at least 1 laboratory, neurological, electrocardiogram, or vital sign measurement obtained subsequent to at least 1 dose of carfilzomib was required for inclusion in the analysis of a safety specific parameter. To assess change from baseline, a baseline measurement was also required."
409922|NCT00511238|O1|Outcome|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
409923|NCT00511238|O1|Outcome|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
409924|NCT00511238|O1|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
Assessed by Independent Review Committee"
409925|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle.
Assesed by principal investigator."
409926|NCT00511238|O2|Outcome|Carfilzomib (A1) for (CBR)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with CBR.
409927|NCT00511238|O1|Outcome|Carfilzomib (A1) for (ORR)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with ORR.
409928|NCT00511238|O1|Outcome|Carfilzomib (A0) for (ORR)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
409929|NCT00511238|O1|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
Assessed by Independent Review Committee"
409930|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle.
Assessed by principal investigator."
409931|NCT00511238|O2|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
Response-Evaluable Population:
had measurable disease at Baseline
received at least 1 dose of carfilzomib
underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"
409932|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib."
409933|NCT00511238|E2|Reported Event|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
409934|NCT00511238|E1|Reported Event|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
409935|NCT00511342|B3|Baseline|Total|Total of all reporting groups
409936|NCT00511342|B2|Baseline|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409937|NCT00511342|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409938|NCT00511342|P2|Participant Flow|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409939|NCT00511342|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409940|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409941|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
410138|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
409943|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409944|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409945|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409946|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409947|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409948|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409949|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409950|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409951|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409952|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409953|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409954|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409955|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409956|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409957|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409958|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409959|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409960|NCT00511342|E2|Reported Event|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409961|NCT00511342|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
409962|NCT00511355|B3|Baseline|Total|Total of all reporting groups
409963|NCT00511355|B2|Baseline|LNG-EE|"All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day cycles"
409964|NCT00511355|B1|Baseline|NOMAC-E2|All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles
410139|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
409965|NCT00511355|P2|Participant Flow|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409966|NCT00511355|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409967|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409968|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409969|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409970|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409971|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles.
n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
409972|NCT00511355|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
409973|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409974|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409975|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409976|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409977|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409978|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409979|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409980|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409981|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409982|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409983|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409984|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409985|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410140|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg Before Each Meal|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
409986|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409987|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409988|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409989|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409990|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409991|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409992|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409993|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409994|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409995|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409996|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409997|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
409998|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
409999|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410000|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410001|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410002|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410003|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410004|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410005|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410006|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410007|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410694|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410008|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410009|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410010|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410011|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410012|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410013|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410014|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410015|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410016|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410017|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410018|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410019|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410020|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410021|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410022|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410023|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410024|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410025|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410026|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410027|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410028|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410029|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410695|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410030|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410031|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410032|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410033|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410034|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410035|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410036|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410037|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410038|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410039|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410040|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410041|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410042|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410043|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410044|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410045|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410046|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410047|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410048|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410049|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410050|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410051|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410696|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410052|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410053|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410054|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410055|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410056|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410057|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410058|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410059|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410060|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410061|NCT00511355|E2|Reported Event|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
410062|NCT00511355|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
410063|NCT00511433|B3|Baseline|Total|Total of all reporting groups
410064|NCT00511433|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410065|NCT00511433|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410066|NCT00511433|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410067|NCT00511433|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410068|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410069|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410070|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410071|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410072|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410073|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410074|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410697|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410075|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410076|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410077|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410078|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410079|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410080|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410081|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410082|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410083|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410084|NCT00511433|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
410085|NCT00511433|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
410086|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410087|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410088|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410089|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410090|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410091|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410092|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410093|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410094|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410095|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410096|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410698|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410097|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410098|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410099|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410100|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410101|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410102|NCT00511433|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410103|NCT00511433|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
410104|NCT00511472|B3|Baseline|Total|Total of all reporting groups
410105|NCT00511472|B2|Baseline|Placebo|Participants receiving placebo while on basal insulin.
410106|NCT00511472|B1|Baseline|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
410107|NCT00511472|P2|Participant Flow|Placebo|Participants receiving placebo while on basal insulin.
410108|NCT00511472|P1|Participant Flow|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
410109|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin
410110|NCT00511472|O1|Outcome|MK-0941|Participants receiving individualized doses of MK-0941 while on basal insulin
410111|NCT00511472|O3|Outcome|Placebo|Participants receiving placebo while on basal insulin.
410112|NCT00511472|O2|Outcome|MK-0941 (Titration Group 2)|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #2 while on basal insulin.
410113|NCT00511472|O1|Outcome|MK-0941 (Titration Group 1)|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #1 while on basal insulin.
410114|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
410115|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #2 while on basal insulin.
410116|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
410117|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #1 while on basal insulin.
410118|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
410119|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
410120|NCT00511472|E4|Reported Event|Placebo Titration 2|Participants receiving placebo while on basal insulin.
410121|NCT00511472|E3|Reported Event|Placebo Titration 1|Participants receiving placebo while on basal insulin.
410122|NCT00511472|E2|Reported Event|MK-0941 Titration 2|Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 2 while on basal insulin.
410123|NCT00511472|E1|Reported Event|MK-0941 Titration 1|Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 1 while on basal insulin.
410124|NCT00511667|B3|Baseline|Total|Total of all reporting groups
410125|NCT00511667|B2|Baseline|Placebo|All participants receiving any dose of placebo
410126|NCT00511667|B1|Baseline|MK-0941|All participants receiving any dose of MK-0941
410127|NCT00511667|P2|Participant Flow|Placebo|All participants receiving any dose of placebo
410128|NCT00511667|P1|Participant Flow|MK-0941|All participants receiving any dose of MK-0941
410129|NCT00511667|O2|Outcome|Placebo|All participants receiving any dose of placebo
410130|NCT00511667|O1|Outcome|MK-0941|All participants receiving any dose of MK-0941
410131|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
410132|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
410133|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
410134|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
410135|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
410136|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
410137|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
410141|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
410142|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
410143|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
410144|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
410145|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
410146|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
410147|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
410148|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
410149|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
410150|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
410151|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
410152|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
410153|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
410154|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
410155|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
410156|NCT00511667|O2|Outcome|Placebo|All participants receiving any dose of placebo
410157|NCT00511667|O1|Outcome|MK-0941|All participants receiving any dose of MK-0941
410158|NCT00511667|E2|Reported Event|Placebo|All participants receiving any dose of placebo
410159|NCT00511667|E1|Reported Event|MK-0941|All participants receiving any dose of MK-0941
410160|NCT00511706|B3|Baseline|Total|Total of all reporting groups
410161|NCT00511706|B2|Baseline|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
410162|NCT00511706|B1|Baseline|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
410163|NCT00511706|P2|Participant Flow|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
410164|NCT00511706|P1|Participant Flow|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
410165|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
410166|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
410167|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
410168|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
410169|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
410170|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
410171|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
410172|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
410173|NCT00511706|E2|Reported Event|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
410174|NCT00511706|E1|Reported Event|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
410175|NCT00511797|B5|Baseline|Total|Total of all reporting groups
410176|NCT00511797|B4|Baseline|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410177|NCT00511797|B3|Baseline|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410178|NCT00511797|B2|Baseline|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410179|NCT00511797|B1|Baseline|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410180|NCT00511797|P4|Participant Flow|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410181|NCT00511797|P3|Participant Flow|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410182|NCT00511797|P2|Participant Flow|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410183|NCT00511797|P1|Participant Flow|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410184|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410185|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410186|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410381|NCT00512252|B4|Baseline|Total|Total of all reporting groups
410187|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410188|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410189|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410190|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410191|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410192|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410193|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410194|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410195|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410196|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410197|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410198|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410199|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410200|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410201|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410202|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410203|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410204|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410205|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410206|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410207|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410208|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410209|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410210|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410211|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410212|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410213|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410214|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410215|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410216|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410217|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410218|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410219|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410220|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410221|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410222|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410223|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410224|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410225|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410226|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
425911|NCT00542425|O1|Outcome|Placebo|
410227|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410228|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410229|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410230|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410231|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410232|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410233|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410234|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410235|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410236|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410237|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410238|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410239|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410240|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410241|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410242|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410243|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410244|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410245|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410246|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410247|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410248|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410249|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410250|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410251|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410252|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410253|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410254|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410255|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410256|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410257|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410258|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410259|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410260|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410261|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410262|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410263|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410264|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410265|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410266|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410267|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410268|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410269|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410270|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410271|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410272|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410273|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410274|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410275|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410276|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410277|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410278|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410279|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410280|NCT00511797|E4|Reported Event|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
410281|NCT00511797|E3|Reported Event|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410282|NCT00511797|E2|Reported Event|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410283|NCT00511797|E1|Reported Event|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
410284|NCT00511810|B3|Baseline|Total|Total of all reporting groups
410285|NCT00511810|B2|Baseline|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)
Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
410286|NCT00511810|B1|Baseline|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
410287|NCT00511810|P2|Participant Flow|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)
Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
410288|NCT00511810|P1|Participant Flow|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
410289|NCT00511810|O2|Outcome|Baseline CDRS-R: Low Dose Fish Oil|CDRS-R scores were computed for Low Fish Oil groups.
410290|NCT00511810|O1|Outcome|Baseline CDRS-R: High Dose Fish Oil|CDRS-R scores were computed for High Fish Oil groups.
410291|NCT00511810|E2|Reported Event|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)
Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
410292|NCT00511810|E1|Reported Event|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
410293|NCT00511836|B3|Baseline|Total|Total of all reporting groups
410294|NCT00511836|B2|Baseline|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
410295|NCT00511836|B1|Baseline|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
410296|NCT00511836|P2|Participant Flow|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
410297|NCT00511836|P1|Participant Flow|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
410298|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
410299|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
410300|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
410301|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
410302|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
410303|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
410304|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
410305|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
410306|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
410307|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
410699|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410308|NCT00511836|E3|Reported Event|Optional Open-label VIVITROL Period (2 Months)|Following the 28-day, double-blind treatment period, all subjects were offered a chance to receive open-label VIVITROL for an additional 2 months (2 injections, each separated by 1 month). Safety data are described for all subjects in the VIVITROL open-label period, regardless of the treatment received (VIVITROL or placebo) for the first month.
410309|NCT00511836|E2|Reported Event|Placebo (Double-blind Period)|Placebo for VIVITROL 380 mg. Data are described for the initial 28-day double-blind period.
410310|NCT00511836|E1|Reported Event|VIVITROL 380 mg (Double-blind Period)|VIVITROL 380 mg (naltrexone for extended-release injectable suspension). Data are described for the initial 28-day double-blind period.
410311|NCT00511862|B4|Baseline|Total|Total of all reporting groups
410312|NCT00511862|B3|Baseline|Non-Colorectal/Non-neuroendocrine|patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy
410313|NCT00511862|B2|Baseline|Neuroendocrine Cancer|neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy
410314|NCT00511862|B1|Baseline|Colorectal Cancer|colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy
410315|NCT00511862|P3|Participant Flow|Non-Colorectal/Non-neuroendocrine|Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
410316|NCT00511862|P2|Participant Flow|Neuroendocrine Cancer|Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
410317|NCT00511862|P1|Participant Flow|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
410318|NCT00511862|O1|Outcome|Neuroendocrine Cancer|neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy
410319|NCT00511862|O3|Outcome|All Patients|All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
410320|NCT00511862|O2|Outcome|Non Colorectal/Non-Neuroendocrine|Patients with metastatic liver disease arising from primary cancers other than colorectal or neuroendocrine cancer who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
410321|NCT00511862|O1|Outcome|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
410322|NCT00511862|O4|Outcome|All Patients|All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
410323|NCT00511862|O3|Outcome|Non-Colorectal/Non-neuroendocrine|Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
410324|NCT00511862|O2|Outcome|Neuroendocrine Cancer|Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
410325|NCT00511862|O1|Outcome|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
410326|NCT00511862|E1|Reported Event|TheraSphere|total population receiving at least one TheraSphere treatment
410327|NCT00511901|B3|Baseline|Total|Total of all reporting groups
410328|NCT00511901|B2|Baseline|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410329|NCT00511901|B1|Baseline|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410330|NCT00511901|P2|Participant Flow|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410331|NCT00511901|P1|Participant Flow|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410332|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410333|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410334|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410335|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410336|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410337|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410338|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410339|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410340|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410341|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410342|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410343|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410344|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410346|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410347|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410348|NCT00511901|E2|Reported Event|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410349|NCT00511901|E1|Reported Event|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
410350|NCT00511914|B3|Baseline|Total|Total of all reporting groups
410351|NCT00511914|B2|Baseline|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410352|NCT00511914|B1|Baseline|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410353|NCT00511914|P2|Participant Flow|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410354|NCT00511914|P1|Participant Flow|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410355|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410356|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410357|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410358|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410359|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410360|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410361|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410362|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410363|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410364|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410365|NCT00511914|E2|Reported Event|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410366|NCT00511914|E1|Reported Event|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
410367|NCT00511992|B1|Baseline|Avastin|"Avastin: Initial Treatment:
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)
Consolidation Treatment:
Avastin 15mg/kg IV every 21 days x 12 cycles"
410368|NCT00511992|P1|Participant Flow|Avastin|"Avastin: Initial Treatment:
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)
Consolidation Treatment:
Avastin 15mg/kg IV every 21 days x 12 cycles"
410369|NCT00511992|O1|Outcome|Avastin|"Avastin: Initial Treatment:
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)
Consolidation Treatment:
Avastin 15mg/kg IV every 21 days x 12 cycles"
410370|NCT00511992|O1|Outcome|Avastin|"Avastin: Initial Treatment:
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)
Consolidation Treatment:
Avastin 15mg/kg IV every 21 days x 12 cycles"
410371|NCT00511992|E1|Reported Event|Avastin|"Avastin: Initial Treatment:
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)
Consolidation Treatment:
Avastin 15mg/kg IV every 21 days x 12 cycles"
410372|NCT00512096|B1|Baseline|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
410373|NCT00512096|P1|Participant Flow|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
410374|NCT00512096|O1|Outcome|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
410375|NCT00512096|E1|Reported Event|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
410376|NCT00512148|B1|Baseline|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
410377|NCT00512148|P1|Participant Flow|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
410378|NCT00512148|O1|Outcome|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
410379|NCT00512148|O1|Outcome|All Implanted|The number of subjects implanted with the neobladder augment
410380|NCT00512148|E1|Reported Event|Safety Population|Patients who underwent screening procedures and met inclusion/exclusion criteria.
410700|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410382|NCT00512252|B3|Baseline|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).
The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
410383|NCT00512252|B2|Baseline|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
410384|NCT00512252|B1|Baseline|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
410385|NCT00512252|P3|Participant Flow|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).
The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
410386|NCT00512252|P2|Participant Flow|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
410387|NCT00512252|P1|Participant Flow|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
410388|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
410389|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
410390|NCT00512252|O4|Outcome|Total|Phase II Dose Patients
410391|NCT00512252|O3|Outcome|>= Second Relapse/Salvage|
410392|NCT00512252|O2|Outcome|Primary Refractory|
410393|NCT00512252|O1|Outcome|First Relapse, First Salvage|
410394|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
410395|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
410396|NCT00512252|O3|Outcome|Phase I Dose Escalation - Dose Level 3|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
410397|NCT00512252|O2|Outcome|Phase I Dose Escalation - Dose Level 2|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
410398|NCT00512252|O1|Outcome|Phase I Dose Escalation - Dose Level 1|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
410399|NCT00512252|O3|Outcome|Phase I Dose Escalation - Dose Level 3|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
410400|NCT00512252|O2|Outcome|Phase I Dose Escalation - Dose Level 2|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
410401|NCT00512252|O1|Outcome|Phase I Dose Escalation - Dose Level 1|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
410402|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
410403|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
410404|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
410405|NCT00512252|O1|Outcome|Phase I Dose Escalation/Phase II Dose Treatment|
410406|NCT00512252|O4|Outcome|Total|Phase II Dose Patients
410407|NCT00512252|O3|Outcome|>= Second Relapse/Salvage|
410408|NCT00512252|O2|Outcome|Primary Refractory|
410409|NCT00512252|O1|Outcome|First Relapse, First Salvage|
410410|NCT00512252|O1|Outcome|Phase I Dose Escalation|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
410411|NCT00512252|E3|Reported Event|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).
The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
410412|NCT00512252|E2|Reported Event|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
410413|NCT00512252|E1|Reported Event|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5
Mitoxantrone on days 1-5
Etoposide on days 1-5
Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
410414|NCT00506285|B3|Baseline|Total|Total of all reporting groups
410415|NCT00506285|B2|Baseline|B Placebo Patch Was Used First|Placebo patch was used in the first treatment arm and MTS in the second treatment arm.
410416|NCT00506285|B1|Baseline|a) Methylphenidate Transdermal System Was Taken First|Subjects took Methylphenidate Transdermal System in the first treatment arm and placebo patch in the second treatment arm
410442|NCT00506389|E5|Reported Event|Esmirtazapine 4.5 mg Follow-up|After participants received placebo tablets during the Placebo Washout Period and 4.5 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
425912|NCT00542425|E5|Reported Event|Teriparatide|
410417|NCT00506285|P2|Participant Flow|B) PBO Arm Was 1st and MTS Arm Was 2nd|Placebo was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 MTS patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
410418|NCT00506285|P1|Participant Flow|A) MTS Arm Was 1st and PBO Arm Was 2nd|MTS was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 placebo patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
410419|NCT00506285|O2|Outcome|Scores in Placebo Arm|Average CAARS score at end of placebo treatment
410420|NCT00506285|O1|Outcome|Scores in MTS Arm|Average CAARS score at end of active treatment
410421|NCT00506285|O2|Outcome|Scores in Placebo Arm|Average WRAADDS scores at end of placebo arm
410422|NCT00506285|O1|Outcome|Scores in MTS Arm|Average WRAADDS scores at end of active treatment (MTS) arm
410423|NCT00506285|E2|Reported Event|Placebo Arm|Adverse events and Serious AEs during placebo arm
410424|NCT00506285|E1|Reported Event|MTS Arm|Adverse events and Serious AEs during active treatment (MTS) arm
410425|NCT00506389|B4|Baseline|Total|Total of all reporting groups
410426|NCT00506389|B3|Baseline|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410427|NCT00506389|B2|Baseline|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410428|NCT00506389|B1|Baseline|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410429|NCT00506389|P3|Participant Flow|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410430|NCT00506389|P2|Participant Flow|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410431|NCT00506389|P1|Participant Flow|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410432|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410433|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410434|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410435|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410436|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410437|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410438|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410439|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410440|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
410441|NCT00506389|E6|Reported Event|Placebo Follow-up|After participants received placebo tablets during the Placebo Washout Period and placebo during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
410473|NCT00506441|P2|Participant Flow|Placebo|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
410443|NCT00506389|E4|Reported Event|Esmirtazapine 3.0 mg Follow-up|After participants received placebo tablets during the Placebo Washout Period and 3.0 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
410444|NCT00506389|E3|Reported Event|Placebo In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
410445|NCT00506389|E2|Reported Event|Esmirtazapine 4.5 mg In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
410446|NCT00506389|E1|Reported Event|Esmirtazapine 3.0 mg In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
410447|NCT00506415|B1|Baseline|Total Patients|Total number of patients enrolled in the initial open label period that may have been randomized in the double blind period or may have continued in the extended open label period.
410448|NCT00506415|P4|Participant Flow|Extended Open Label (10 cm^2)|Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks (from week 48 to week 96) open label treatment.
410449|NCT00506415|P3|Participant Flow|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
410450|NCT00506415|P2|Participant Flow|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
410451|NCT00506415|P1|Participant Flow|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Rivastigmine 5 cm^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
410452|NCT00506415|O4|Outcome|Extended Open Label (10 cm^2)|Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.
410453|NCT00506415|O3|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15c m^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
410454|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
410455|NCT00506415|O1|Outcome|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Rivastigmine 5 cm^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
410456|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
410457|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
410458|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
410459|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during the double blind period.
410460|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
410461|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
410462|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
410463|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
410464|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
410465|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
410466|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
410467|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
410468|NCT00506415|E4|Reported Event|Extended Open Label: Rivastigmine (10 cm^2)|Safety population Extended Open Label (Safety-EOL) - This population consisted of all patients who received at least 1 dose of study drug during the extended open label phase and had at least 1 post baseline safety assessment during the same phase.
410469|NCT00506415|E3|Reported Event|Double Blind: Rivastigmine (15 cm^2)|Safety population Double Blind (Safety-DB) - This population included all patients who were randomized, received at least 1 dose of study drug during the double blind phase and had at least 1 post-randomization safety assessment during the double blind phase. Patients were analyzed according to treatment received.
410470|NCT00506415|E2|Reported Event|Double Blind: Rivastigmine (10 cm^2)|Safety population Double Blind (Safety-DB) - This population included all patients who were randomized, received at least 1 dose of study drug during the double blind phase and had at least 1 post-randomization safety assessment during the double blind phase. Patients were analyzed according to treatment received.
410471|NCT00506415|E1|Reported Event|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Safety population Initial Open Label (Safety-IOL) - This population consisted of all patients who received at least 1 dose of study drug during the initial open label phase and had at least 1 post baseline safety assessment during the same phase.
410472|NCT00506441|B1|Baseline|MCI-196|"Open-label Period (Week 0 - 12) ; 3, 6, 9, 12, or 15 g/ day as titrated
Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period"
410474|NCT00506441|P1|Participant Flow|MCI-196|"Open-label Period (Week 0 -12) ; 3, 6, 9, 12, or 15 g/ day as titrated
Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period"
410475|NCT00506441|O1|Outcome|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated (Week 0 -12)
410476|NCT00506441|O2|Outcome|Placebo (Double-blind Period)|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
410477|NCT00506441|O1|Outcome|MCI-196 (Double-blind Period)|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
410478|NCT00506441|E3|Reported Event|Placebo (Double-blind Period)|"dose level at the end of dose titration in the Open-label period (Week 12-16)
One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period."
410479|NCT00506441|E2|Reported Event|MCI-196 (Double-blind Period)|"dose level at the end of dose titration in the Open-label period (Week 12-16)
One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period."
410480|NCT00506441|E1|Reported Event|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15 g/ day as titrated (Week 0-12)
410481|NCT00506454|B3|Baseline|Total|Total of all reporting groups
410482|NCT00506454|B2|Baseline|Placebo|Participants receiving the placebo.
410483|NCT00506454|B1|Baseline|Active|Participants receiving the active drug.
410484|NCT00506454|P2|Participant Flow|Placebo|Participants receiving the placebo.
410485|NCT00506454|P1|Participant Flow|Active|Participants receiving the active drug.
410486|NCT00506454|O2|Outcome|Placebo|Participants receiving the placebo.
410487|NCT00506454|O1|Outcome|Treatment|Participants receiving the active drug.
410488|NCT00506454|E2|Reported Event|Placebo|Participants receiving the placebo.
410489|NCT00506454|E1|Reported Event|Active|Participants receiving the active drug.
410490|NCT00506493|B1|Baseline|Study Completion Cohort|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
410491|NCT00506493|P1|Participant Flow|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
410492|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated with the Cardioblate Surgical Ablation System.. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
410493|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated with the Cardioblate Surgical Ablation System.. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
410494|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|All subjects who underwent surgical ablation with the Cardioblate Surgical Ablation System.
410495|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who underwent surgical ablation with the Cardioblate Surgical Ablation system and completed a Holter assessment at 9 month follow-up
410496|NCT00506493|E1|Reported Event|Study Completion Cohort|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
410497|NCT00506597|B1|Baseline|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
410498|NCT00506597|P1|Participant Flow|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
410499|NCT00506597|O1|Outcome|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
410500|NCT00506597|E1|Reported Event|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
410501|NCT00512707|B3|Baseline|Total|Total of all reporting groups
410502|NCT00512707|B2|Baseline|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410503|NCT00512707|B1|Baseline|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410504|NCT00512707|P2|Participant Flow|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410684|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410505|NCT00512707|P1|Participant Flow|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410506|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410507|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410508|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410509|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410510|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410511|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410512|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410513|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410514|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410515|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410516|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410517|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410518|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410519|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410520|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410521|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410522|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410685|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410686|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410523|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410524|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410525|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410526|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410527|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410528|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410529|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410530|NCT00512707|O2|Outcome|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410531|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410532|NCT00512707|E2|Reported Event|Placebo|"Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
410533|NCT00512707|E1|Reported Event|Testosterone|"Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
410534|NCT00512798|B3|Baseline|Total|Total of all reporting groups
410535|NCT00512798|B2|Baseline|Phase II|
410536|NCT00512798|B1|Baseline|Phase I|
410537|NCT00512798|P2|Participant Flow|Phase II|PS-341 and Temozolomide will be administered in the same manner as in Phase I at doses as determined by the Phase I portion of the trial.
410538|NCT00512798|P1|Participant Flow|Phase I|PS-341 will be administered intravenously at 1.0 mg/m2 of body weight beginning on days 1, 4, 8, and 11 of every 21 days. If toxicity occurs, dose will be lowered to 0.7 mg/m2. Dose can be raised to a maximum of 1.5 mg/m2. Temozolomide will be orally administered daily at 50 mg/m2 of body weight beginning on day 8 for 6 weeks of every 9-week cycle, followed by a 3-week rest. Minimum dose is 50 mg/m2 and maximum dose is 75 mg/m2.
410539|NCT00512798|O1|Outcome|Phase II|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior treatment with Dacarbazine or Temozolomide with treatment failure.
410540|NCT00512798|O1|Outcome|Phase II|Phase II patients who were available for blood draw on the designated days.
410541|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
410542|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
410543|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
410544|NCT00512798|E2|Reported Event|Phase II|
410545|NCT00512798|E1|Reported Event|Phase I|
410546|NCT00512876|B1|Baseline|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
410547|NCT00512876|P1|Participant Flow|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
410548|NCT00512876|O1|Outcome|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
410549|NCT00512876|O1|Outcome|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
410550|NCT00512876|E1|Reported Event|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye
410551|NCT00512902|B1|Baseline|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
410552|NCT00512902|P1|Participant Flow|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
410553|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
410554|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
410555|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
410556|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
410557|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
410558|NCT00512902|E1|Reported Event|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
410559|NCT00513799|B5|Baseline|Total|Total of all reporting groups
410560|NCT00513799|B4|Baseline|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
410561|NCT00513799|B3|Baseline|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
410562|NCT00513799|B2|Baseline|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
410563|NCT00513799|B1|Baseline|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
410687|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410688|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
425913|NCT00542425|E4|Reported Event|BA058 80 µg|
410564|NCT00513799|P4|Participant Flow|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
410565|NCT00513799|P3|Participant Flow|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
410566|NCT00513799|P2|Participant Flow|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
410567|NCT00513799|P1|Participant Flow|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
410568|NCT00513799|O4|Outcome|4: Education + Mupirocin + Bleach Baths|"A combination of nasal application of mupirocin and bathing in dilute bleach water
Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
Bleach baths (dilute): Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.
Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
410569|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|"A combination of nasal application of mupirocin and chlorhexidine showers
Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
Chlorhexidine showers: Apply Clorhexidine wash to entire body once daily for 5 days.
Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
410570|NCT00513799|O2|Outcome|2: Hygiene Education + Mupirocin|"Application of mupirocin in the nasal mucosa alone
Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
410571|NCT00513799|O1|Outcome|1: Hygiene Education|"Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)
Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
410572|NCT00513799|O4|Outcome|4: Education + Mupirocin + Bleach Baths|"A combination of nasal application of mupirocin and bathing in dilute bleach water
Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
Bleach baths (dilute): Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.
Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
410573|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|"A combination of nasal application of mupirocin and chlorhexidine showers
Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
Chlorhexidine showers: Apply Clorhexidine wash to entire body once daily for 5 days.
Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
410574|NCT00513799|O2|Outcome|2: Hygiene Education + Mupirocin|"Application of mupirocin in the nasal mucosa alone
Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
410575|NCT00513799|O1|Outcome|1: Hygiene Education|"Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)
Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
410576|NCT00513799|O4|Outcome|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
410577|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
410578|NCT00513799|O2|Outcome|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
410579|NCT00513799|O1|Outcome|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
410580|NCT00513799|E4|Reported Event|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
410581|NCT00513799|E3|Reported Event|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
410582|NCT00513799|E2|Reported Event|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
410583|NCT00513799|E1|Reported Event|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
410689|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
425914|NCT00542425|E3|Reported Event|BA058 40 µg|
410584|NCT00514020|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
410585|NCT00514020|P1|Participant Flow|5-FU, Leucovorin, Oxaliplatin|"Patients who have TSER*2/*2 or TSER*2/*3 genotypes will receive the modified FOLFOX-6 treatment. Patients homozygous for TSER*3 will not be included in study.
FOLFOX-6 chemotherapy: oxaliplatin IV in 500 ml D5W over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15.
Treatment courses repeat every 2 weeks +/- 3 days (2 treatments per cycle) in the absence of unacceptable toxicity or disease progression. Disease assessments will be performed after 8 weeks (2 cycles) of treatment."
410586|NCT00514020|O1|Outcome|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
410587|NCT00514020|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
410588|NCT00514137|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
410589|NCT00514137|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
410590|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
410591|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
410592|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
410593|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
410594|NCT00514137|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
410595|NCT00514215|B1|Baseline|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32
sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42
flow cytometry: Days 1 & 32
immunoenzyme technique: Days 1 & 32
biopsy: CT guided biopsy on days 1 & 32
cryosurgery: Days 1 and 32"
410596|NCT00514215|P1|Participant Flow|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32
sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42
flow cytometry: Days 1 & 32
immunoenzyme technique: Days 1 & 32
biopsy: CT guided biopsy on days 1 & 32
cryosurgery: Days 1 and 32"
410597|NCT00514215|O1|Outcome|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32
sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42
flow cytometry: Days 1 & 32
immunoenzyme technique: Days 1 & 32
biopsy: CT guided biopsy on days 1 & 32
cryosurgery: Days 1 and 32"
410598|NCT00514215|E1|Reported Event|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32
sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42
flow cytometry: Days 1 & 32
immunoenzyme technique: Days 1 & 32
biopsy: CT guided biopsy on days 1 & 32
cryosurgery: Days 1 and 32"
410599|NCT00514501|B1|Baseline|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
410600|NCT00514501|P1|Participant Flow|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
410601|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
410602|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
410603|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
410604|NCT00514501|E1|Reported Event|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
410605|NCT00514514|B4|Baseline|Total|Total of all reporting groups
410606|NCT00514514|B3|Baseline|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410690|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
425915|NCT00542425|E2|Reported Event|BA058 20 µg|
410607|NCT00514514|B2|Baseline|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410608|NCT00514514|B1|Baseline|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410609|NCT00514514|P3|Participant Flow|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410610|NCT00514514|P2|Participant Flow|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410611|NCT00514514|P1|Participant Flow|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410612|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410613|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410614|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410615|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410616|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410617|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410618|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410619|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410620|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410621|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410622|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410623|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410624|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410625|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410626|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410627|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410628|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410629|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410630|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410631|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410632|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410633|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410634|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410635|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410636|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410691|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410692|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410637|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410638|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410639|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410640|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410641|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410642|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410643|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410644|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410645|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410646|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410647|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410648|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410649|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
410650|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410651|NCT00514514|E3|Reported Event|CNI-low|"CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
410652|NCT00514514|E2|Reported Event|CNI-free|"CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids"
410653|NCT00514514|E1|Reported Event|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
410654|NCT00514592|B1|Baseline|All Patients|All patients are in the same group
410655|NCT00514592|P1|Participant Flow|All Patients|All patients enter the same group
410656|NCT00514592|O1|Outcome|All Patients|All patients enter the same group
410657|NCT00514592|O1|Outcome|All Patients|All patients enter the same group
410658|NCT00514592|E1|Reported Event|All Patients|All patients enter the same group
410659|NCT00514683|B6|Baseline|Total|Total of all reporting groups
410660|NCT00514683|B5|Baseline|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410661|NCT00514683|B4|Baseline|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410662|NCT00514683|B3|Baseline|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410663|NCT00514683|B2|Baseline|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410664|NCT00514683|B1|Baseline|Placebo|Patients were treated with matching Placebo.
410665|NCT00514683|P5|Participant Flow|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410666|NCT00514683|P4|Participant Flow|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410667|NCT00514683|P3|Participant Flow|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410668|NCT00514683|P2|Participant Flow|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410669|NCT00514683|P1|Participant Flow|Placebo|Patients were treated with matching Placebo.
410670|NCT00514683|O4|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410671|NCT00514683|O3|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410672|NCT00514683|O2|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410673|NCT00514683|O1|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410674|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410675|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410676|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410677|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410678|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410679|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410680|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410681|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410682|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410683|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410705|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410706|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410707|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410708|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410709|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410710|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410711|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410712|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410713|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410714|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410715|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410716|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410717|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410718|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410719|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410720|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410721|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410722|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410723|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410724|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410725|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410726|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410727|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410728|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410729|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410730|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410731|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410732|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410733|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410734|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410735|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410736|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410737|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410738|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410739|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410740|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410741|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410742|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410743|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410744|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410745|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410746|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410747|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410748|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410749|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410750|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410751|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410752|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410753|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410754|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410755|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410756|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410757|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410758|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410759|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410760|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410761|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410762|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410763|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410764|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410765|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410766|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410767|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410768|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410769|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410770|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410771|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410772|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410773|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410774|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410775|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410776|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410777|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410778|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410779|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410780|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410781|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410782|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410783|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410784|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410785|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410786|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410787|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410788|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410789|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410790|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410791|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410792|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410793|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410794|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410795|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410796|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410797|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410798|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410799|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410800|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410801|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410802|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410803|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410804|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410805|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410806|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410807|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410808|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410809|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410810|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410811|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410812|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410813|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410814|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410815|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410816|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410817|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410818|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410819|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410820|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410821|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410822|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410823|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410824|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410825|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410826|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410827|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410828|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410829|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410830|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410831|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410832|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410833|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410834|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410835|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410836|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410837|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410838|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410839|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410840|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410841|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410842|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410843|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410844|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410845|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410846|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410847|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410848|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410849|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410850|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410851|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410852|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410853|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
410854|NCT00514683|E5|Reported Event|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
410855|NCT00514683|E4|Reported Event|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
410856|NCT00514683|E3|Reported Event|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
410857|NCT00514683|E2|Reported Event|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
410858|NCT00514683|E1|Reported Event|Placebo|Patients were treated with matching Placebo.
410859|NCT00514709|B3|Baseline|Total|Total of all reporting groups
410860|NCT00514709|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
410861|NCT00514709|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
410862|NCT00514709|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
410863|NCT00514709|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
410864|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
410865|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
410866|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
410867|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP-T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP-T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
410868|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
410869|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
410870|NCT00514709|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
410908|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
425916|NCT00542425|E1|Reported Event|Placebo|
410871|NCT00514709|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
410872|NCT00514735|B3|Baseline|Total|Total of all reporting groups
410909|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
410873|NCT00514735|B2|Baseline|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
410874|NCT00514735|B1|Baseline|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
410875|NCT00514735|P2|Participant Flow|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
410876|NCT00514735|P1|Participant Flow|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
410877|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
410878|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
410879|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
410880|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
410881|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
410882|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
412842|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
410910|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
410911|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
410912|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
410883|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
410884|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
410885|NCT00514735|O1|Outcome|Ablation Management|
410886|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
410887|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
410888|NCT00514735|O1|Outcome|Ablation Management|
410889|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
410890|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
410891|NCT00514735|E2|Reported Event|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
410892|NCT00514735|E1|Reported Event|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
410893|NCT00514813|B5|Baseline|Total|Total of all reporting groups
410894|NCT00514813|B4|Baseline|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
410895|NCT00514813|B3|Baseline|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
410896|NCT00514813|B2|Baseline|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
410897|NCT00514813|B1|Baseline|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
410898|NCT00514813|P4|Participant Flow|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
410899|NCT00514813|P3|Participant Flow|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
410900|NCT00514813|P2|Participant Flow|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
410901|NCT00514813|P1|Participant Flow|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
410902|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
410903|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
410904|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
410905|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
410906|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
410907|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
410913|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
410914|NCT00514813|E4|Reported Event|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
410915|NCT00514813|E3|Reported Event|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
410916|NCT00514813|E2|Reported Event|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
410917|NCT00514813|E1|Reported Event|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
410918|NCT00514852|B3|Baseline|Total|Total of all reporting groups
410919|NCT00514852|B2|Baseline|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410920|NCT00514852|B1|Baseline|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410921|NCT00514852|P2|Participant Flow|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410922|NCT00514852|P1|Participant Flow|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410923|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410924|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410925|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410926|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410927|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410928|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410929|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410930|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410931|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410932|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410933|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410934|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410935|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410936|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410937|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410938|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410939|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410940|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410941|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410942|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410943|NCT00514852|E2|Reported Event|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410944|NCT00514852|E1|Reported Event|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
410945|NCT00514917|B3|Baseline|Total|Total of all reporting groups
410946|NCT00514917|B2|Baseline|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410947|NCT00514917|B1|Baseline|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410948|NCT00514917|P2|Participant Flow|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410949|NCT00514917|P1|Participant Flow|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410950|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410951|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
411080|NCT00515034|E3|Reported Event|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
410952|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
411188|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
410953|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410954|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410955|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410956|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410957|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410958|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410959|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410960|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410961|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410962|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410963|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410964|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410965|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410966|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410967|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410968|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg/m^2 subcutaneous injection for every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410969|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles along with leuprolide 22.5 mg/m^2subcutaneous injection for every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410970|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410971|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410972|NCT00514917|E2|Reported Event|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410973|NCT00514917|E1|Reported Event|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
410974|NCT00514943|B3|Baseline|Total|Total of all reporting groups
410975|NCT00514943|B2|Baseline|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
411081|NCT00515034|E2|Reported Event|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
411189|NCT00515203|E2|Reported Event|Romiplostim|
411190|NCT00515203|E1|Reported Event|Placebo|
412865|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
410976|NCT00514943|B1|Baseline|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
410977|NCT00514943|P2|Participant Flow|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
410978|NCT00514943|P1|Participant Flow|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
410979|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
410980|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
410981|NCT00514943|O1|Outcome|Afatinib 40 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1, and had sequential dose reduction to 40 mg in stage 1.
410982|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
410983|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
410984|NCT00514943|O1|Outcome|Afatinib 40 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1, and had sequential dose reduction to 40 mg in stage 1.
410985|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
410986|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
410987|NCT00514943|O4|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
410988|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
410989|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
410990|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
410991|NCT00514943|O4|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
410992|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
410993|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
410994|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
410995|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
410996|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
410997|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
410998|NCT00514943|O1|Outcome|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
410999|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
411000|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
411001|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
411002|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
411003|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
412843|NCT00518687|E2|Reported Event|Placebo|Placebo : 0.5-ml single injection of matching placebo
411004|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
411005|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
411006|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
411007|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
411008|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
411009|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
411010|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
411011|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
411012|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
411013|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
411014|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
411015|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
411016|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
411017|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
411018|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
411019|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
411020|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
411021|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
411022|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
411023|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
411024|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
411025|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
411026|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
411027|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
411028|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
411029|NCT00514943|E4|Reported Event|Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 1|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
411030|NCT00514943|E3|Reported Event|Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
411031|NCT00514943|E2|Reported Event|Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
412862|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
411032|NCT00514943|E1|Reported Event|Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
411033|NCT00515008|B3|Baseline|Total|Total of all reporting groups
411034|NCT00515008|B2|Baseline|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
411035|NCT00515008|B1|Baseline|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
411036|NCT00515008|P2|Participant Flow|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program. Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks. At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyalgia, including the diagnostic criteria; coping strategies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physical and mental health; exercise; and wellness and lifestyle management. For the final 20 minutes of each class, participants practiced stretching exercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day.
411037|NCT00515008|P1|Participant Flow|Tai Chi Group|12-week Tai Chi Program.: The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 minutes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and techniques. In subsequent sessions, participants practiced 10 forms from the classic Yang style of tai chi under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the intervention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
411038|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
411039|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
411040|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
411041|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
411042|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
411043|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
411044|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
411045|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
411046|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
411047|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
411048|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
411049|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
411050|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and
lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
411051|NCT00515008|O1|Outcome|Tai Chi|The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
411052|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and
lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
411082|NCT00515034|E1|Reported Event|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
411100|NCT00515086|O2|Outcome|No Surgery ( ≥ 2 Previous Relapses)|Participants with recurrent Glioblastoma Multiforme (GBM) with ≥ 2 previous relapses not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus until evidence of disease progression or toxicity.
411101|NCT00515086|O1|Outcome|No Surgery (1 Previous Relapse)|Participants with recurrent Glioblastoma Multiforme (GBM) with 1 previous relapse not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
411053|NCT00515008|O1|Outcome|Tai Chi|"The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai
chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks."
411054|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and
lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
411055|NCT00515008|O1|Outcome|Tai Chi|"The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai
chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks."
411056|NCT00515008|E2|Reported Event|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
411057|NCT00515008|E1|Reported Event|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
411058|NCT00515034|B5|Baseline|Total|Total of all reporting groups
411059|NCT00515034|B4|Baseline|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
411060|NCT00515034|B3|Baseline|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
411061|NCT00515034|B2|Baseline|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
411062|NCT00515034|B1|Baseline|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
411063|NCT00515034|P4|Participant Flow|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
411064|NCT00515034|P3|Participant Flow|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
411065|NCT00515034|P2|Participant Flow|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
411066|NCT00515034|P1|Participant Flow|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
411067|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
411068|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
411069|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
411070|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
411071|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
411072|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
411073|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
411074|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
411075|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
411076|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
411077|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
411078|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
411079|NCT00515034|E4|Reported Event|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
411083|NCT00515073|B1|Baseline|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.
Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
411084|NCT00515073|P1|Participant Flow|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.
Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
411085|NCT00515073|O1|Outcome|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.
Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
411086|NCT00515073|E1|Reported Event|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.
Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
411087|NCT00515086|B5|Baseline|Total|Total of all reporting groups
411088|NCT00515086|B4|Baseline|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411089|NCT00515086|B3|Baseline|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411090|NCT00515086|B2|Baseline|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411091|NCT00515086|B1|Baseline|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
411092|NCT00515086|P4|Participant Flow|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411093|NCT00515086|P3|Participant Flow|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411094|NCT00515086|P2|Participant Flow|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411095|NCT00515086|P1|Participant Flow|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
411096|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411097|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411098|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411099|NCT00515086|O3|Outcome|Total : No Surgery|Total participants enrolled with recurrent glioblastoma multiforme (GBM) who were not scheduled to undergo a planned salvage surgical resection. All participants in this arm were to receive a fixed daily dose of 10 mg/day oral everolimus.
411184|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
411102|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411103|NCT00515086|O2|Outcome|Everolimus 5mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411104|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411105|NCT00515086|O4|Outcome|Total|All the participants scheduled to undergo salvage surgical resection from three pre-surgery treatment groups (i.e 0, 5 or 10 mg/day (once daily) everolimus X 7 days).
411106|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411107|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411108|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411109|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411110|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411111|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411112|NCT00515086|O2|Outcome|No Surgery ( ≥ 2 Previous Relapses)|Participants with recurrent Glioblastoma Multiforme with ≥ 2 previous relapses not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus until evidence of disease progression or toxicity.
411113|NCT00515086|O1|Outcome|No Surgery (1 Previous Relapse)|Participants with recurrent Glioblastoma Multiforme (GBM) with 1 previous relapse not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
411114|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411115|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411116|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411117|NCT00515086|E4|Reported Event|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
411118|NCT00515086|E3|Reported Event|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411119|NCT00515086|E2|Reported Event|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411120|NCT00515086|E1|Reported Event|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
411121|NCT00515099|B3|Baseline|Total|Total of all reporting groups
411122|NCT00515099|B2|Baseline|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411123|NCT00515099|B1|Baseline|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411124|NCT00515099|P2|Participant Flow|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411125|NCT00515099|P1|Participant Flow|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411126|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411127|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411128|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411129|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411130|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411131|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411132|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411133|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411134|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411135|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411136|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411137|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411138|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411139|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
411140|NCT00515099|E2|Reported Event|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg.
411141|NCT00515099|E1|Reported Event|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg.
411142|NCT00515112|B3|Baseline|Total|Total of all reporting groups
411143|NCT00515112|B2|Baseline|Placebo|"Three subjects received the placebo
Placebo: placebo"
411144|NCT00515112|B1|Baseline|Androgel|"Three subjects received testosterone gel
AndroGel: Androgel 1%, 10g daily"
411145|NCT00515112|P2|Participant Flow|Placebo|"Three subjects received the placebo
Placebo: placebo"
411146|NCT00515112|P1|Participant Flow|Androgel|"Three subjects received testosterone gel
AndroGel: Androgel 1%, 10g daily"
411147|NCT00515112|O2|Outcome|Placebo|"Three subjects received the placebo
Placebo: placebo"
411148|NCT00515112|O1|Outcome|Androgel|"Three subjects received testosterone gel
AndroGel: Androgel 1%, 10g daily"
411149|NCT00515112|O2|Outcome|Placebo|"Three subjects received the placebo
Placebo: placebo"
411150|NCT00515112|O1|Outcome|Androgel|"Three subjects received testosterone gel
AndroGel: Androgel 1%, 10g daily"
411151|NCT00515112|E2|Reported Event|Placebo|"Three subjects received the placebo
Placebo: placebo"
411152|NCT00515112|E1|Reported Event|Androgel|"Three subjects received testosterone gel
AndroGel: Androgel 1%, 10g daily"
411153|NCT00515177|B3|Baseline|Total|Total of all reporting groups
411154|NCT00515177|B2|Baseline|Randomized to PCT|
411155|NCT00515177|B1|Baseline|Randomized to MBSR|
411156|NCT00515177|P2|Participant Flow|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
411157|NCT00515177|P1|Participant Flow|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
411158|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
411185|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
411186|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
411187|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
411159|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
411160|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
411161|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
411162|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
411163|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
411164|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
411165|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
411166|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use."
411167|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
411168|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
411169|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
411170|NCT00515177|E2|Reported Event|MBSR|Mindfulness-Based Stress Reduction (MBSR) is an 8 week program of yoga and mindfulness training taught by a trained instructor in a group format.
411171|NCT00515177|E1|Reported Event|Pharmacotherapy (Eszopiclone, 3mg)|The PCT control treatment consisted of 3mg eszopiclone nightly for 8 weeks, followed by use as needed for 3 months.
411172|NCT00515203|B3|Baseline|Total|Total of all reporting groups
411173|NCT00515203|B2|Baseline|Placebo|Placebo by subcutaneous injection once weekly
411174|NCT00515203|B1|Baseline|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
411175|NCT00515203|P2|Participant Flow|Placebo|Placebo by subcutaneous injection once weekly
411176|NCT00515203|P1|Participant Flow|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
411177|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
411178|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
411179|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
411180|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
411181|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
411182|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
411183|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
412844|NCT00518687|E1|Reported Event|V710 (60 µg) Lyophilized|V710: 0.5-ml single injection of V710 (60 µg)
411191|NCT00515216|B1|Baseline|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411192|NCT00515216|P1|Participant Flow|Oxaliplatin/Leucovorin/5-FU|"“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype
Chemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)"
411193|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411194|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411195|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411196|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411197|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411198|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411199|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411200|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411201|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411202|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411203|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411204|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411205|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411206|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411207|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|"“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype
Chemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)"
411208|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411209|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411210|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
412845|NCT00518713|B5|Baseline|Total|Total of all reporting groups
411211|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411212|NCT00515216|E1|Reported Event|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
411213|NCT00515294|B5|Baseline|Total|Total of all reporting groups
411214|NCT00515294|B4|Baseline|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
411215|NCT00515294|B3|Baseline|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
411216|NCT00515294|B2|Baseline|2Non-Caffeinated Alcoholic Beer|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
411217|NCT00515294|B1|Baseline|1Caffeinated Alcoholic Beer|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
411218|NCT00515294|P4|Participant Flow|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
411219|NCT00515294|P3|Participant Flow|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
411220|NCT00515294|P2|Participant Flow|2Non-Caffeinated Alcoholic Beer|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
411221|NCT00515294|P1|Participant Flow|1Caffeinated Alcoholic Beer|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
411222|NCT00515294|O4|Outcome|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
411223|NCT00515294|O3|Outcome|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
411224|NCT00515294|O2|Outcome|2Non-Caffeinated Alcoholic Beer|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
411225|NCT00515294|O1|Outcome|1Caffeinated Alcoholic Beer|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
411226|NCT00515294|O4|Outcome|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
411227|NCT00515294|O3|Outcome|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
411228|NCT00515294|O2|Outcome|2Non-Caffeinated Alcoholic Beer|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
411229|NCT00515294|O1|Outcome|1Caffeinated Alcoholic Beer|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
411230|NCT00515294|E4|Reported Event|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
411231|NCT00515294|E3|Reported Event|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
411232|NCT00515294|E2|Reported Event|2Non-Caffeinated Alcohol|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
411233|NCT00515294|E1|Reported Event|1Caffeinated Alcohol|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
411234|NCT00515437|B5|Baseline|Total|Total of all reporting groups
411235|NCT00515437|B4|Baseline|Placebo|Placebo
411236|NCT00515437|B3|Baseline|3500U Myobloc|3500U Myobloc
411237|NCT00515437|B2|Baseline|2500U Myobloc|2500U Myobloc
411238|NCT00515437|B1|Baseline|1500U Myobloc|1500U Myobloc
411239|NCT00515437|P4|Participant Flow|Placebo|Placebo
411240|NCT00515437|P3|Participant Flow|3500U Myobloc|3500U Myobloc
411241|NCT00515437|P2|Participant Flow|2500U Myobloc|2500U Myobloc
411242|NCT00515437|P1|Participant Flow|1500U Myobloc|1500U Myobloc
411243|NCT00515437|O4|Outcome|Placebo|Placebo
411244|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
411245|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
411246|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
411247|NCT00515437|O4|Outcome|Placebo|Placebo
411248|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
411249|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
411250|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
411251|NCT00515437|O4|Outcome|Placebo|Placebo
411252|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
411253|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
411254|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
411255|NCT00515437|O4|Outcome|Placebo|Placebo
411256|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
411257|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
411258|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
411259|NCT00515437|E4|Reported Event|Placebo|Placebo
411260|NCT00515437|E3|Reported Event|3500U Myobloc|3500U Myobloc
411261|NCT00515437|E2|Reported Event|2500U Myobloc|2500U Myobloc
411262|NCT00515437|E1|Reported Event|1500U Myobloc|1500U Myobloc
411263|NCT00515463|B3|Baseline|Total|Total of all reporting groups
411264|NCT00515463|B2|Baseline|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411265|NCT00515463|B1|Baseline|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411266|NCT00515463|P2|Participant Flow|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411267|NCT00515463|P1|Participant Flow|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411268|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411269|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411270|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
425917|NCT00542542|B3|Baseline|Total|Total of all reporting groups
411271|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411272|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411273|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411274|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411275|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411276|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411277|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411278|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411279|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411280|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411281|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411282|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411283|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411284|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411285|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411286|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411287|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411288|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411289|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411290|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411291|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411292|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411293|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411294|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411295|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411296|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411297|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411298|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411299|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411300|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411301|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411302|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411303|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411304|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411305|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411306|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411307|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411308|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411309|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411310|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411311|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411312|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
427910|NCT00551746|O1|Outcome|Purple Grape Juice|100% grape juice
411313|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411314|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411315|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411316|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411317|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411318|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411319|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411320|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411321|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411322|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411323|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411324|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411325|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411326|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411327|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411328|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411329|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411330|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411331|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411332|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411333|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411334|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411335|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411336|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411337|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411338|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411339|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411340|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411341|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411342|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411343|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411344|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411345|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411346|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411347|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411348|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411349|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411350|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411351|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411352|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411353|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411354|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
429085|NCT00556075|O1|Outcome|Placebo|Placebo: 1capsule daily for 4 months
411355|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411356|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411357|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411358|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411359|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411360|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411361|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411362|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411363|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411364|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411365|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411366|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411367|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411368|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411369|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411370|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411371|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411372|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411373|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411374|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411375|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411376|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411377|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411378|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411379|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411380|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411381|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411382|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411383|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411384|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411385|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411386|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411387|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411388|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411389|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411390|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411391|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411392|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411393|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411394|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411395|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411396|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
430372|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
411397|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411398|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411399|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411400|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411401|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411402|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411403|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411404|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411405|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411406|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411407|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411408|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411409|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411410|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411411|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411412|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe (PFS) on Day 1 and at Month 6.
411413|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411414|NCT00515463|E2|Reported Event|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
411415|NCT00515463|E1|Reported Event|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
411416|NCT00515502|B1|Baseline|All Study Treatments|Participants received a sequence containing 4 of the following 5 possible treatments: placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and Tiotropium 18 µg. Participants received each of the treatments in 1 of 4 single dose treatment periods, each of which was followed by a washout period. Treatment periods 1, 2, and 3 were followed by at least a 14-day washout period; Treatment period 4 was followed by a Follow-up visit within 10 days.
411417|NCT00515502|P12|Participant Flow|Seq 12: UMEC 250 µg, Placebo, UMEC 500 µg, Tiotropium 18 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and Tiotropium 18 µg. Treatment periods were seperated by a washout period of at least 14 days.
411418|NCT00515502|P11|Participant Flow|Seq 11: Placebo, UMEC 250 µg, Tiotropium 18 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
411419|NCT00515502|P10|Participant Flow|Seq 10: Tiotropium 18 µg, UMEC 250 µg, Placebo, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, placebo and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
411420|NCT00515502|P9|Participant Flow|Seq 9: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
411421|NCT00515502|P8|Participant Flow|Seq 8: Tiotropium 18 µg, Placebo, UMEC 250 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, placebo, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
411422|NCT00515502|P7|Participant Flow|Seq 7: Placebo, Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, Tiotropium 18 µg, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
411423|NCT00515502|P6|Participant Flow|Seq 6: UMEC 250 µg, Placebo, Tiotropium 18 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
411424|NCT00515502|P5|Participant Flow|Seq 5: Placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
411425|NCT00515502|P4|Participant Flow|Seq 4: UMEC 250 µg, UMEC 500 µg, Placebo, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, placebo and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
411426|NCT00515502|P3|Participant Flow|Seq 3: UMEC 250 µg, Placebo, UMEC 500 µg, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
411458|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411427|NCT00515502|P2|Participant Flow|Seq 2: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
411428|NCT00515502|P1|Participant Flow|Seq 1: UMEC 250 µg, UMEC 500 µg, Tiotropium 18 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: umeclidinium bromide (UMEC) 250 micrograms (µg), UMEC 500 µg, Tiotropium 18 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
411429|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411430|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411431|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411432|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411433|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411434|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411435|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411436|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411437|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411438|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411439|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411440|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411441|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411442|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411443|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411444|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411445|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411446|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411447|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411448|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411449|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411450|NCT00515502|O1|Outcome|UMEC 250 µg|
411451|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411452|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411453|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411454|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411455|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411456|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411457|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411459|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
412866|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
411460|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411461|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411462|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411463|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411464|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411465|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411466|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411467|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411468|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411469|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411470|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411471|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411472|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411473|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411474|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411475|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411476|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411477|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411478|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411479|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411480|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411481|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411482|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411483|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411484|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411485|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411486|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411487|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411488|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411489|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
430385|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
411490|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411491|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411492|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411493|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411494|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411495|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411496|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411497|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411498|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411499|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411500|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411501|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411502|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411503|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411504|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411505|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411506|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411507|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411508|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411509|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411510|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411511|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411512|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411513|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411514|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411515|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411516|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411517|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411518|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411519|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411520|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
430386|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
411521|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411522|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411523|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411524|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411525|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411526|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411527|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411528|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411529|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411530|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411531|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411532|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411533|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411534|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411535|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411536|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411537|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411538|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411539|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411540|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411541|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411542|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411543|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411544|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411545|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411546|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411547|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411548|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411549|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411550|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411551|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
430387|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
411552|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411553|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411554|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411555|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411556|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411557|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411558|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411559|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411560|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411561|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411562|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411563|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411564|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411565|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411566|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411567|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411568|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411569|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411570|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411571|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411572|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411573|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411574|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411575|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411576|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411577|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411578|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 micrograms (µg) via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411579|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411580|NCT00515502|E5|Reported Event|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411581|NCT00515502|E4|Reported Event|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411582|NCT00515502|E3|Reported Event|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411583|NCT00515502|E2|Reported Event|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411584|NCT00515502|E1|Reported Event|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
411585|NCT00515541|B5|Baseline|Total|Total of all reporting groups
411586|NCT00515541|B4|Baseline|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject is taking Warfarin and Aspirin (< or = 325mg)and is not taking Clopidogrel. Subject is taking escalating doses of Lovaza over a 24 week period.
411587|NCT00515541|B3|Baseline|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject is taking Clopidogrel 75mg)and Aspirin (< or = 325mg) and not taking Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
411588|NCT00515541|B2|Baseline|Group. B: Subject on Lovaza + Aspirin|Group B: Subject on Aspirin (< or = 325mg and is not taking Clopidogrel or Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
411589|NCT00515541|B1|Baseline|Group A: Subject on Lovaza Only|Group A: Subject is not on Aspirin, Clopidogrel, or Warfarin. Subject is taking escalating doses of study drug (Lovaza)over a 24 week period.
411590|NCT00515541|P4|Participant Flow|Group D: Subjects on Lovaza Plus Warfarin and Aspirin|Subject is regularly taking Warfarin and Aspirin (< or = 325mg)daily, and not taking Clopidogrel. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Warfarin and Aspirin up to 24 weeks.
411591|NCT00515541|P3|Participant Flow|Group C: Subjects on Lovaza Plus Clopidogrel and Aspirin|Subject is regularly taking Clopidogrel (75mg)and Aspirin (< or = 325mg)daily, and not taking Warfarin. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Clopidogrel and Aspirin up to 24 weeks.
411592|NCT00515541|P2|Participant Flow|Group B: Subjects on Lovaza Plus Aspirin|Group B: Subject is only taking Aspirin (< or = 325mg) daily. Subjects will be taking escalating doses of study drug (Lovaza) in addition to aspirin up to 24 weeks.
411593|NCT00515541|P1|Participant Flow|Group A: Subjects on Lovaza Only|Group A: Subject is healthly and not on Aspirin, Clopidogrel, or Warfarin. Subjects will be taking escalating doses of the study drug (Lovaza)up to 24 weeks.
411594|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
411595|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411596|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411597|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411598|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
411599|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411600|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411601|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411602|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
411603|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411604|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411605|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411606|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
411607|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411608|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411609|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
411610|NCT00515541|E4|Reported Event|Group D|Lovaza plus aspirin plus coumadin
411611|NCT00515541|E3|Reported Event|Group C|Lovaza plus clopidogrel
411612|NCT00515541|E2|Reported Event|Group B|Lovaza plus aspirin
411613|NCT00515541|E1|Reported Event|Group A|Lovaza only
411614|NCT00515619|B1|Baseline|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
411615|NCT00515619|P1|Participant Flow|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
411616|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
411617|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
412867|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
411618|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
411619|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
411620|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
411621|NCT00515619|E1|Reported Event|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
411622|NCT00515671|B3|Baseline|Total|Total of all reporting groups
411623|NCT00515671|B2|Baseline|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
411624|NCT00515671|B1|Baseline|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
411625|NCT00515671|P2|Participant Flow|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
411626|NCT00515671|P1|Participant Flow|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
411627|NCT00515671|O2|Outcome|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
411628|NCT00515671|O1|Outcome|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
411629|NCT00515671|O2|Outcome|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
411630|NCT00515671|O1|Outcome|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
411631|NCT00515671|E2|Reported Event|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
411632|NCT00515671|E1|Reported Event|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
411633|NCT00515697|B1|Baseline|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
411634|NCT00515697|P1|Participant Flow|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
411635|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
411636|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
411637|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
411638|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
411639|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
411640|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
411641|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
411642|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
411643|NCT00515697|E1|Reported Event|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
411644|NCT00515827|B3|Baseline|Total|Total of all reporting groups
411645|NCT00515827|B2|Baseline|Placebo Then Raltegravir (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.
411646|NCT00515827|B1|Baseline|Raltegravir Then Placebo (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
411647|NCT00515827|P2|Participant Flow|Placebo Then Raltegravir (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.
411648|NCT00515827|P1|Participant Flow|Raltegravir Then Placebo (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
411649|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
411650|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
411651|NCT00515827|O2|Outcome|Raltegravir (Arm B)|400 mg raltegravir (MK-0518) administered twice daily in addition to OBR from week 12 to week 24
411652|NCT00515827|O1|Outcome|Placebo (Arm A)|Placebo administered twice daily in addition to optimized background regimen (OBR) from week 12 to week 24
411653|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
411654|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
411655|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
411656|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
411657|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
411658|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
411659|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
411660|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
411661|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
411662|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
411663|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
411664|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
411665|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
411666|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
411667|NCT00515827|E2|Reported Event|Placebo|Week 12 to Week 24 for Arm A (Raltegravir then Placebo), and Baseline to Week 12 for Arm B (Placebo then Raltegravir).
411668|NCT00515827|E1|Reported Event|Raltegravir|Baseline to Week 12 for Arm A (Raltegravir then Placebo), and Week 12 to Week 24 for Arm B (Placebo then Raltegravir).
411669|NCT00515879|B3|Baseline|Total|Total of all reporting groups
411670|NCT00515879|B2|Baseline|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
411671|NCT00515879|B1|Baseline|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
411672|NCT00515879|P2|Participant Flow|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
411673|NCT00515879|P1|Participant Flow|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
411674|NCT00515879|O2|Outcome|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
411675|NCT00515879|O1|Outcome|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
411676|NCT00515879|O2|Outcome|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
411677|NCT00515879|O1|Outcome|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
411678|NCT00515879|E2|Reported Event|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
411679|NCT00515879|E1|Reported Event|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
411680|NCT00516048|B3|Baseline|Total|Total of all reporting groups
411681|NCT00516048|B2|Baseline|Positive Baseline (Week 0) Antibody Status|Patients assessed as positive for antibodies to exenatide at baseline (Week 0).
411682|NCT00516048|B1|Baseline|Negative Baseline (Week 0) Antibody Status|Patients assessed as negative for antibodies to exenatide at baseline (Week 0).
411683|NCT00516048|P3|Participant Flow|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
411684|NCT00516048|P2|Participant Flow|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
411685|NCT00516048|P1|Participant Flow|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
411686|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
411687|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
411688|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
411689|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
412846|NCT00518713|B4|Baseline|Placebo|tablets; orally; daily for 15-18 weeks
411690|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
411691|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
411692|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
411693|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
411694|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
411695|NCT00516048|E3|Reported Event|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
411696|NCT00516048|E2|Reported Event|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
411697|NCT00516048|E1|Reported Event|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
411698|NCT00516074|B3|Baseline|Total|Total of all reporting groups
411699|NCT00516074|B2|Baseline|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
411700|NCT00516074|B1|Baseline|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
411701|NCT00516074|P2|Participant Flow|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
411702|NCT00516074|P1|Participant Flow|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
411703|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
411704|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
411705|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
411706|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
411707|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
411708|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
411709|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
411710|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
411711|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
411712|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
411713|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
411714|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
411715|NCT00516074|E2|Reported Event|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
411716|NCT00516074|E1|Reported Event|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
411717|NCT00516139|B1|Baseline|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411718|NCT00516139|P1|Participant Flow|Lamotrigine (LTG)-Extended Release (XR) Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411750|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
411757|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
411759|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
411719|NCT00516139|O1|Outcome|LTG-XR + Neutral, EIAEDs, and VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA and EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411720|NCT00516139|O1|Outcome|LTG-XR + Neutral, EIAEDs, and VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA and EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411721|NCT00516139|O3|Outcome|LTG-XR + VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA), followed by an 8-w Adjunctive Maintenance Phase: LTG-XR tablets administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411722|NCT00516139|O2|Outcome|LTG-XR + EIAEDs|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411723|NCT00516139|O1|Outcome|LTG-XR + Neutral|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (does not include VPA or EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411724|NCT00516139|O3|Outcome|LTG-XR + VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA), followed by an 8-w Adjunctive Maintenance Phase: LTG-XR tablets administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411725|NCT00516139|O2|Outcome|LTG-XR + EIAEDs|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411751|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
411752|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
411726|NCT00516139|O1|Outcome|LTG-XR + Neutral|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (does not include VPA or EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411727|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411728|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411729|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411730|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411731|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411732|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411753|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
411758|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
411733|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411734|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411735|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411736|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411737|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411738|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411739|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411754|NCT00516165|E1|Reported Event|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
411755|NCT00516217|B1|Baseline|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
411740|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411741|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411742|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411743|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411744|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411745|NCT00516139|E1|Reported Event|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
411746|NCT00516165|B1|Baseline|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
411747|NCT00516165|P1|Participant Flow|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
411748|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
411749|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
411756|NCT00516217|P1|Participant Flow|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
411760|NCT00516217|E1|Reported Event|Galaximab|Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
411761|NCT00516269|B3|Baseline|Total|Total of all reporting groups
411762|NCT00516269|B2|Baseline|Placebo Then Methylphenidate|"Placebo : Capsule By Mouth Daily x 2 Weeks
Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
411763|NCT00516269|B1|Baseline|Methylphenidate Then Placebo|"18 mg Oral Daily for 2 Weeks
Placebo : Capsule By Mouth Daily x 2 Weeks
Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
411764|NCT00516269|P2|Participant Flow|Placebo Then Methylphenidate|Placebo oral daily for 2 weeks then Methylphenidate 18 mg oral daily for 2 weeks
411765|NCT00516269|P1|Participant Flow|Methylphenidate Then Placebo|Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks
411766|NCT00516269|O2|Outcome|Placebo|Placebo taken oral daily for 2 Weeks.
411767|NCT00516269|O1|Outcome|Methylphenidate|Methylphenidate 18 mg oral daily for 2 Weeks preceded or followed by Placebo oral daily for 2 weeks.
411768|NCT00516269|E2|Reported Event|Placebo Then Methylphenidate|"Placebo : Capsule By Mouth Daily x 2 Weeks
Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
411769|NCT00516269|E1|Reported Event|Methylphenidate Then Placebo|"18 mg Oral Daily for 2 Weeks
Placebo : Capsule By Mouth Daily x 2 Weeks
Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
411770|NCT00509496|B3|Baseline|Total|Total of all reporting groups
411771|NCT00509496|B2|Baseline|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days
cyclophosphamide-60 mg/kg/day x 2 days intravenous
Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes
aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
411772|NCT00509496|B1|Baseline|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days
cyclophosphamide-60 mg/kg/day x 2 days intravenous
Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.
aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
411773|NCT00509496|P2|Participant Flow|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days
cyclophosphamide-60 mg/kg/day x 2 days intravenous
Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes
aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
411774|NCT00509496|P1|Participant Flow|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days
cyclophosphamide-60 mg/kg/day x 2 days intravenous
Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.
aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
411775|NCT00509496|O2|Outcome|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days
cyclophosphamide-60 mg/kg/day x 2 days intravenous
Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes
aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
411776|NCT00509496|O1|Outcome|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days
cyclophosphamide-60 mg/kg/day x 2 days intravenous
Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.
aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
411777|NCT00509496|O2|Outcome|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days
cyclophosphamide-60 mg/kg/day x 2 days intravenous
Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes
aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
411778|NCT00509496|O1|Outcome|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days
cyclophosphamide-60 mg/kg/day x 2 days intravenous
Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.
aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
411779|NCT00509496|E2|Reported Event|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days
cyclophosphamide-60 mg/kg/day x 2 days intravenous
Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes
aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
412184|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
411954|NCT00510068|P2|Participant Flow|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411780|NCT00509496|E1|Reported Event|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days
cyclophosphamide-60 mg/kg/day x 2 days intravenous
Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.
aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
411781|NCT00509587|B1|Baseline|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
411782|NCT00509587|P1|Participant Flow|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
411783|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
411784|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
411785|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
411786|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
411787|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
411788|NCT00509587|E1|Reported Event|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
411789|NCT00509600|B1|Baseline|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
411790|NCT00509600|P1|Participant Flow|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
411791|NCT00509600|O1|Outcome|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
411792|NCT00509600|E1|Reported Event|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
411793|NCT00509769|B1|Baseline|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
411794|NCT00509769|P1|Participant Flow|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
411795|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
411796|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
411797|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
411798|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
411799|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
411800|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
411801|NCT00509769|E1|Reported Event|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
411802|NCT00509795|B5|Baseline|Total|Total of all reporting groups
411803|NCT00509795|B4|Baseline|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
411804|NCT00509795|B3|Baseline|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411805|NCT00509795|B2|Baseline|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411806|NCT00509795|B1|Baseline|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
411953|NCT00510068|B1|Baseline|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411807|NCT00509795|P4|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and received sham injections at interim monthly visits.
411808|NCT00509795|P3|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411809|NCT00509795|P2|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411810|NCT00509795|P1|Participant Flow|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year.
411811|NCT00509795|O5|Outcome|Total|
411812|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
411813|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411814|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411815|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
411816|NCT00509795|O5|Outcome|Total|
411817|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
411818|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411819|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411820|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
411821|NCT00509795|O5|Outcome|Total|
411822|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
411823|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411824|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411825|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
411826|NCT00509795|O5|Outcome|Total|
411827|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
411828|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411829|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411830|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
411831|NCT00509795|O5|Outcome|Total|
411832|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
411833|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411834|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
411835|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
411836|NCT00509795|E4|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
411837|NCT00509795|E3|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
411874|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
430388|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
411838|NCT00509795|E2|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
411839|NCT00509795|E1|Reported Event|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of ranibizumab (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
411840|NCT00509873|B3|Baseline|Total|Total of all reporting groups
411841|NCT00509873|B2|Baseline|Placebo Eye Drops|Placebo eye drops
411842|NCT00509873|B1|Baseline|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
411843|NCT00509873|P2|Participant Flow|Placebo Eye Drops|Placebo eye drops
411844|NCT00509873|P1|Participant Flow|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
411845|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
411846|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
411847|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
411848|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
411849|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
411850|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
411851|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
411852|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
411853|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
411854|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
411855|NCT00509873|E2|Reported Event|Placebo Eye Drops|Placebo eye drops
411856|NCT00509873|E1|Reported Event|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
411857|NCT00509899|B9|Baseline|Total|Total of all reporting groups
411858|NCT00509899|B8|Baseline|200 mg qd|Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411859|NCT00509899|B7|Baseline|100 mg qd|Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411860|NCT00509899|B6|Baseline|50 mg qd|Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411861|NCT00509899|B5|Baseline|25 mg qd|Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy.
411862|NCT00509899|B4|Baseline|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411863|NCT00509899|B3|Baseline|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411864|NCT00509899|B2|Baseline|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411865|NCT00509899|B1|Baseline|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411866|NCT00509899|P8|Participant Flow|200 mg qd|Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411867|NCT00509899|P7|Participant Flow|100 mg qd|Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411868|NCT00509899|P6|Participant Flow|50 mg qd|Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411869|NCT00509899|P5|Participant Flow|25 mg qd|Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy.
411870|NCT00509899|P4|Participant Flow|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411871|NCT00509899|P3|Participant Flow|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411872|NCT00509899|P2|Participant Flow|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411873|NCT00509899|P1|Participant Flow|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
412847|NCT00518713|B3|Baseline|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
411875|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411876|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411877|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411878|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411879|NCT00509899|O1|Outcome|All Participants|All participants received ruxolitinib at varying initial dose and regimen. Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411880|NCT00509899|O4|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
411881|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411882|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411883|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411884|NCT00509899|O4|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
411885|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411886|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411887|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411888|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411889|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411890|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
411891|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411892|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411893|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411894|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411895|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
411896|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411897|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
412066|NCT00516386|O1|Outcome|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
411898|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411899|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411900|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
411901|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411902|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411903|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411904|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411905|NCT00509899|E5|Reported Event|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
411906|NCT00509899|E4|Reported Event|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411907|NCT00509899|E3|Reported Event|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
411908|NCT00509899|E2|Reported Event|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411909|NCT00509899|E1|Reported Event|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
411910|NCT00509925|B1|Baseline|Entire Trial Population|The entire trial population includes groups randomised to receive either insulin detemir or insulin NPH as their first treatment.
411911|NCT00509925|P2|Participant Flow|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411912|NCT00509925|P1|Participant Flow|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411913|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411914|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411915|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411916|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411917|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411918|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411919|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411920|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411921|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411922|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
412848|NCT00518713|B2|Baseline|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
411923|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411924|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411925|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411926|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411927|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411928|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411929|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411930|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411931|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411932|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411933|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411934|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411935|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411936|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
411937|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411938|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411939|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411940|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411941|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411942|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411943|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411944|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411945|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411946|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411947|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411948|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411949|NCT00509925|E2|Reported Event|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411950|NCT00509925|E1|Reported Event|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
411951|NCT00510068|B3|Baseline|Total|Total of all reporting groups
411952|NCT00510068|B2|Baseline|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411955|NCT00510068|P1|Participant Flow|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411956|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411957|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411958|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411959|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411960|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411961|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411962|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411963|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411964|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411965|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411966|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411967|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411968|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411969|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411970|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411971|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411972|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411973|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411974|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411975|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411976|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411977|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411978|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411979|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411980|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411981|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411982|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411983|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411984|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411985|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411986|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411987|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
430389|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
411988|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411989|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411990|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411991|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411992|NCT00510068|E3|Reported Event|Open Label - Everolimus 10mg|Afinitor OL (for data collected in the open-label period of the study): The open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.
411993|NCT00510068|E2|Reported Event|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
411994|NCT00510068|E1|Reported Event|Everolimus 10mg/Day|Afinitor DB: Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
411995|NCT00516295|B4|Baseline|Total|Total of all reporting groups
411996|NCT00516295|B3|Baseline|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
411997|NCT00516295|B2|Baseline|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I
411998|NCT00516295|B1|Baseline|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
vincristine sulfate: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV"
411999|NCT00516295|P3|Participant Flow|Arm III (CTC)|Patients receive vincristine, topotecan hydrochloride, and cyclophosphamide as in arm I.
412000|NCT00516295|P2|Participant Flow|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
412001|NCT00516295|P1|Participant Flow|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
vincristine sulfate: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV"
412002|NCT00516295|O3|Outcome|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
412003|NCT00516295|O2|Outcome|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
412004|NCT00516295|O1|Outcome|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
vincristine sulfate: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV"
412005|NCT00516295|O3|Outcome|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
412006|NCT00516295|O2|Outcome|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
412007|NCT00516295|O1|Outcome|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
vincristine sulfate: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV"
412008|NCT00516295|E3|Reported Event|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
412009|NCT00516295|E2|Reported Event|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
412010|NCT00516295|E1|Reported Event|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride: Given IV
vincristine sulfate: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV"
412011|NCT00516321|B3|Baseline|Total|Total of all reporting groups
412012|NCT00516321|B2|Baseline|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412013|NCT00516321|B1|Baseline|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412849|NCT00518713|B1|Baseline|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412185|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412014|NCT00516321|P3|Participant Flow|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412015|NCT00516321|P2|Participant Flow|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412016|NCT00516321|P1|Participant Flow|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
412017|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412018|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412019|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412020|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412021|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412022|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412023|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412024|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412025|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412026|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412027|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412028|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412029|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412030|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412067|NCT00516386|E1|Reported Event|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
412068|NCT00516503|B3|Baseline|Total|Total of all reporting groups
412850|NCT00518713|P4|Participant Flow|Placebo|tablets; orally; daily for 15-18 weeks
412031|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412032|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412033|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412034|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412035|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412036|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412037|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412038|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412039|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412040|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412041|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412042|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412043|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412044|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412045|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412046|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412047|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412048|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412069|NCT00516503|B2|Baseline|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
412851|NCT00518713|P3|Participant Flow|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412049|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412050|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412051|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412052|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412053|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412054|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412055|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
412056|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
412057|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
412058|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412059|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412060|NCT00516321|E3|Reported Event|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412061|NCT00516321|E2|Reported Event|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
412062|NCT00516321|E1|Reported Event|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
412063|NCT00516386|B1|Baseline|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
412064|NCT00516386|P1|Participant Flow|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
412065|NCT00516386|O1|Outcome|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
412070|NCT00516503|B1|Baseline|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
412071|NCT00516503|P2|Participant Flow|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
412072|NCT00516503|P1|Participant Flow|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
412073|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
412074|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
412075|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
412076|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
412077|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
412078|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
412079|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
412080|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
412081|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
412082|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
412083|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
412084|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
412085|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
412086|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
412087|NCT00516503|E2|Reported Event|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
412088|NCT00516503|E1|Reported Event|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
412089|NCT00517699|B1|Baseline|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
412090|NCT00517699|P1|Participant Flow|Rituximab, Cytarabine, and Methotrexate (MTX)|Participants received single doses of rituximab 750 milligrams per square meter (mg/m^2) intravenously (IV) at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 grams per square meter (g/m^2) IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
412091|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
412092|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
412093|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
412094|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
430390|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
412095|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
412096|NCT00517699|E1|Reported Event|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
412097|NCT00517751|B1|Baseline|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412098|NCT00517751|P1|Participant Flow|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412099|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412100|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412101|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412102|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412103|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412104|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412105|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412106|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412107|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412108|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412109|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412110|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412111|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412112|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412113|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412114|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412115|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412116|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412117|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412118|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
412119|NCT00517751|E1|Reported Event|X-STOP PEEK|In this arm, patients will undergo X-STOP PEEK surgery.
412120|NCT00517829|B3|Baseline|Total|Total of all reporting groups
412121|NCT00517829|B2|Baseline|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
412122|NCT00517829|B1|Baseline|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
412123|NCT00517829|P2|Participant Flow|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
412124|NCT00517829|P1|Participant Flow|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
412125|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
412126|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
412127|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
412128|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
412129|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
412130|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
412131|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
412132|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
412133|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
412134|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
412135|NCT00517829|E2|Reported Event|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
412136|NCT00517829|E1|Reported Event|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
412137|NCT00517881|B1|Baseline|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
412138|NCT00517881|P1|Participant Flow|C.E.R.A.|Participants received subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms (mcg) every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
412139|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
412140|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
412141|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
412142|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
412143|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
412144|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
412145|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
412146|NCT00517881|E1|Reported Event|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
412147|NCT00517933|B3|Baseline|Total|Total of all reporting groups
412148|NCT00517933|B2|Baseline|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412149|NCT00517933|B1|Baseline|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
412150|NCT00517933|P2|Participant Flow|Placebo / Sildenafil|20 mg oral placebo 3 times per day
412151|NCT00517933|P1|Participant Flow|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
412152|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412153|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412154|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412155|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412156|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412157|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412158|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412159|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412160|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412161|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412162|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412163|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412164|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412165|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412166|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412167|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412168|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412169|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412170|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412171|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412172|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412173|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412174|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412175|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412176|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412177|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412178|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412179|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412180|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412181|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412182|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412183|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
430391|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
412186|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412187|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412188|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412189|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412190|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412191|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412192|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
412193|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
412194|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
412195|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
412196|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
412197|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
412198|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
412199|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
412200|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412201|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412202|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412203|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
412204|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
412205|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
412206|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412207|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412208|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412209|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412210|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412211|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
412212|NCT00517933|E2|Reported Event|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
412213|NCT00517933|E1|Reported Event|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
412214|NCT00518011|B3|Baseline|Total|Total of all reporting groups
412215|NCT00518011|B2|Baseline|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412216|NCT00518011|B1|Baseline|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412217|NCT00518011|P2|Participant Flow|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412218|NCT00518011|P1|Participant Flow|Gemcitabine|Participants received Gemcitabine 1000 milligram per meter square (mg/m^2)/day, intravenously (IV) on Days 1, 8, 15 and every 4 weeks for 6 cycles
412219|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412220|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412221|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412222|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412223|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412224|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412225|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412226|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412227|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412228|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
412852|NCT00518713|P2|Participant Flow|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412229|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412230|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412231|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412232|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412233|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412234|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412235|NCT00518011|E2|Reported Event|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
412236|NCT00518011|E1|Reported Event|Gemcitabine|Participants received Gemcitabine (1000 mg/m^2/day), IV on Days 1, 8, 15 of each 4 week cycle for 6 cycles
412237|NCT00518089|B3|Baseline|Total|Total of all reporting groups
412238|NCT00518089|B2|Baseline|Placebo Eye Drops|
412239|NCT00518089|B1|Baseline|Gatifloxacin 0.5% Eye Drops|
412240|NCT00518089|P2|Participant Flow|Placebo Eye Drops|
412241|NCT00518089|P1|Participant Flow|Gatifloxacin 0.5% Eye Drops|
412242|NCT00518089|O2|Outcome|Placebo Eye Drops|
412243|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
412244|NCT00518089|O2|Outcome|Placebo Eye Drops|
412245|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
412246|NCT00518089|O2|Outcome|Placebo Eye Drops|
412247|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
412248|NCT00518089|O2|Outcome|Placebo Eye Drops|
412249|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
412250|NCT00518089|O2|Outcome|Placebo Eye Drops|
412251|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
412252|NCT00518089|E2|Reported Event|Placebo Eye Drops|
412253|NCT00518089|E1|Reported Event|Gatifloxacin 0.5% Eye Drops|
412254|NCT00518115|B11|Baseline|Total|Total of all reporting groups
412255|NCT00518115|B10|Baseline|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412256|NCT00518115|B9|Baseline|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412257|NCT00518115|B8|Baseline|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412258|NCT00518115|B7|Baseline|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412259|NCT00518115|B6|Baseline|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412260|NCT00518115|B5|Baseline|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412261|NCT00518115|B4|Baseline|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412262|NCT00518115|B3|Baseline|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412263|NCT00518115|B2|Baseline|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412264|NCT00518115|B1|Baseline|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412265|NCT00518115|P10|Participant Flow|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412266|NCT00518115|P9|Participant Flow|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412267|NCT00518115|P8|Participant Flow|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412268|NCT00518115|P7|Participant Flow|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412853|NCT00518713|P1|Participant Flow|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412289|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412269|NCT00518115|P6|Participant Flow|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412270|NCT00518115|P5|Participant Flow|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412271|NCT00518115|P4|Participant Flow|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412272|NCT00518115|P3|Participant Flow|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412273|NCT00518115|P2|Participant Flow|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412274|NCT00518115|P1|Participant Flow|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412275|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
412276|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
412277|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
412278|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
412279|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412280|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412281|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412282|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412283|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412284|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412285|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412286|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412287|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412288|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412561|NCT00518323|P2|Participant Flow|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
412290|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412291|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412292|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412293|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412294|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412295|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412296|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412297|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412298|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412299|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412300|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412301|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412302|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412303|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412304|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412305|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412306|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412307|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412308|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412309|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412310|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412311|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412312|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412562|NCT00518323|P1|Participant Flow|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
412313|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412314|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412315|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412316|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412317|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412318|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412319|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412320|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412321|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412322|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412323|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412324|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412325|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412326|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412327|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412328|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412329|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412330|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412331|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412332|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412333|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412334|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412335|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412336|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412466|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412361|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412337|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412338|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412339|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412340|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412341|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412342|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412343|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412344|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412345|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412346|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412347|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412348|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412349|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412350|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412351|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412352|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412353|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412354|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412355|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412356|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412357|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412358|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412359|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412360|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412493|NCT00518284|B5|Baseline|Total|Total of all reporting groups
412563|NCT00518323|O4|Outcome|Placebo|
412362|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412363|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412364|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412365|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412366|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412367|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412368|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412369|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412370|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412371|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412372|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412373|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412374|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412375|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412376|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412377|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412378|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412379|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412380|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412381|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412382|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412383|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412384|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412788|NCT00518531|E1|Reported Event|Treatment Period 1: Alendronate|Participants received alendronate 70 mg orally once a week in year 1.
412385|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412386|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412387|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412388|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412389|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412390|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412391|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412392|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412393|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412394|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412395|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412396|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412397|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412398|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412399|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412400|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412401|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412402|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412403|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412404|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412405|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412406|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412407|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412408|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412789|NCT00518622|B9|Baseline|Total|Total of all reporting groups
430392|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
412435|NCT00518180|P1|Participant Flow|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412409|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412410|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412411|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412412|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412413|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412414|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412415|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412416|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412417|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412418|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412419|NCT00518115|E10|Reported Event|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412420|NCT00518115|E9|Reported Event|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412421|NCT00518115|E8|Reported Event|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412422|NCT00518115|E7|Reported Event|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412423|NCT00518115|E6|Reported Event|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412424|NCT00518115|E5|Reported Event|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412425|NCT00518115|E4|Reported Event|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412426|NCT00518115|E3|Reported Event|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412427|NCT00518115|E2|Reported Event|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
412428|NCT00518115|E1|Reported Event|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
412429|NCT00518180|B4|Baseline|Total|Total of all reporting groups
412430|NCT00518180|B3|Baseline|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412431|NCT00518180|B2|Baseline|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412432|NCT00518180|B1|Baseline|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412433|NCT00518180|P3|Participant Flow|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412434|NCT00518180|P2|Participant Flow|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412436|NCT00518180|O3|Outcome|Tdap → MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8
412437|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV at months 2, 4, and 8
412438|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
412439|NCT00518180|O3|Outcome|Tdap → MenACWY →HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412440|NCT00518180|O2|Outcome|MenACWY→Tdap → HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412441|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412442|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412443|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412444|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412445|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412446|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
412447|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412448|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412449|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
412450|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412451|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412452|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
412453|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412454|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412455|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
412456|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412457|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412458|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412459|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412460|NCT00518180|O2|Outcome|HPV Alone|The three injections of the HPV vaccine was administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.
412461|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412462|NCT00518180|O2|Outcome|HPV Alone|Three injections of the HPV vaccine were administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.
412463|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412464|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412465|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
412790|NCT00518622|B8|Baseline|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
412467|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412468|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412469|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412470|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412471|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
412472|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
412473|NCT00518180|E3|Reported Event|Tdap → MenACWY → HPV|Tdpa was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2,4 and 8.
412474|NCT00518180|E2|Reported Event|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdpa vaccine at month 1, followed by three injections of the HPV at months 2,4 and 8.
412475|NCT00518180|E1|Reported Event|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
412476|NCT00518206|B3|Baseline|Total|Total of all reporting groups
412477|NCT00518206|B2|Baseline|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412478|NCT00518206|B1|Baseline|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412479|NCT00518206|P2|Participant Flow|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412480|NCT00518206|P1|Participant Flow|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412481|NCT00518206|O2|Outcome|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412482|NCT00518206|O1|Outcome|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412483|NCT00518206|O2|Outcome|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412484|NCT00518206|O1|Outcome|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412485|NCT00518206|O2|Outcome|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412486|NCT00518206|O1|Outcome|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412487|NCT00518206|O2|Outcome|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412488|NCT00518206|O1|Outcome|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412489|NCT00518206|O2|Outcome|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412490|NCT00518206|O1|Outcome|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412491|NCT00518206|E2|Reported Event|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412492|NCT00518206|E1|Reported Event|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
412564|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
412494|NCT00518284|B4|Baseline|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412495|NCT00518284|B3|Baseline|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412496|NCT00518284|B2|Baseline|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412497|NCT00518284|B1|Baseline|Control|Following revascularization, participants did not receive any study drug treatment.
412498|NCT00518284|P4|Participant Flow|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412499|NCT00518284|P3|Participant Flow|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412500|NCT00518284|P2|Participant Flow|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412501|NCT00518284|P1|Participant Flow|Control|Following revascularization, participants did not receive any study drug treatment.
412502|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412503|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412504|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412505|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412506|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412507|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412508|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412509|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412510|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412511|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412512|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412513|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412514|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412515|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412516|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412517|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412518|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412519|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412520|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412521|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412522|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412523|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412524|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412525|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412854|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
412526|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412527|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412528|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412529|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412530|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412531|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412532|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412533|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412534|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412535|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412536|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412537|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412538|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412539|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412540|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412541|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412542|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412543|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412544|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412545|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412546|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412547|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412548|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412549|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
412550|NCT00518284|E4|Reported Event|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412551|NCT00518284|E3|Reported Event|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
412552|NCT00518284|E2|Reported Event|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
412553|NCT00518284|E1|Reported Event|Control|Following revascularization, participants did not receive any study drug treatment.
412554|NCT00518323|B5|Baseline|Total|Total of all reporting groups
412555|NCT00518323|B4|Baseline|Placebo|
412556|NCT00518323|B3|Baseline|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
412557|NCT00518323|B2|Baseline|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
412558|NCT00518323|B1|Baseline|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
412559|NCT00518323|P4|Participant Flow|Placebo|
412560|NCT00518323|P3|Participant Flow|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
412855|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412565|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
412566|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
412567|NCT00518323|O4|Outcome|Placebo|
412568|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
412569|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
412570|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
412571|NCT00518323|O4|Outcome|Placebo|
412572|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
412573|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
412574|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
412575|NCT00518323|O4|Outcome|Placebo|
412576|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
412577|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
412578|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
412579|NCT00518323|O4|Outcome|Placebo|
412580|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
412581|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
412582|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
412583|NCT00518323|E4|Reported Event|Placebo|
412584|NCT00518323|E3|Reported Event|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
412585|NCT00518323|E2|Reported Event|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
412586|NCT00518323|E1|Reported Event|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
412587|NCT00518336|B3|Baseline|Total|Total of all reporting groups
412588|NCT00518336|B2|Baseline|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412589|NCT00518336|B1|Baseline|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412590|NCT00518336|P2|Participant Flow|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412591|NCT00518336|P1|Participant Flow|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412592|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412593|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412594|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412595|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412596|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412597|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412598|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412791|NCT00518622|B7|Baseline|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
412799|NCT00518622|P7|Participant Flow|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
412599|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412600|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412601|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412602|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412603|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412604|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412605|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412606|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412607|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412608|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412609|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412610|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412611|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412612|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412613|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412614|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412615|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412616|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412617|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412618|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412619|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412792|NCT00518622|B6|Baseline|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.
Patients received 125 mg of MK7009 on the morning of Day 8."
412620|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412621|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412622|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412623|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412624|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412625|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412626|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412627|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412628|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412629|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412630|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412631|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412632|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412633|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412634|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412635|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412636|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412637|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412638|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412639|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412640|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412793|NCT00518622|B5|Baseline|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412856|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412641|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412642|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412643|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412644|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412645|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412646|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412647|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412648|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412649|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412650|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412651|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412652|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412653|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412654|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412655|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412656|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412657|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412658|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412659|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412660|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412661|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412794|NCT00518622|B4|Baseline|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412857|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412662|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412663|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412664|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412665|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412666|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412667|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412668|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412669|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412670|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412671|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412672|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412673|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412674|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412675|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412676|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412677|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412678|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412679|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412680|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412681|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412682|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412795|NCT00518622|B3|Baseline|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412858|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
412683|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412684|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412685|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412686|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412687|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412688|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412689|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412690|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412691|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412692|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412693|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412694|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412695|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412696|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412697|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412698|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412699|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412700|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412701|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412702|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412703|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412796|NCT00518622|B2|Baseline|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412859|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412704|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412705|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412706|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412707|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412708|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412709|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412710|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412711|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412712|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412713|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412714|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412715|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412716|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412717|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412718|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412719|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412720|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412721|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412722|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412723|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412724|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412797|NCT00518622|B1|Baseline|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412860|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412725|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412726|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412727|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412728|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412729|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412730|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412731|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412732|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412733|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412734|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412735|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412736|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412737|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412738|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412739|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412740|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412741|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412742|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412743|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412744|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412745|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412798|NCT00518622|P8|Participant Flow|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
412861|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412746|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412747|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412748|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412749|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412750|NCT00518336|E2|Reported Event|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412751|NCT00518336|E1|Reported Event|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
412752|NCT00518531|B3|Baseline|Total|Total of all reporting groups
412753|NCT00518531|B2|Baseline|Denosumab in Period 1 Then Alendronate in Period 2|Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
412754|NCT00518531|B1|Baseline|Alendronate in Period 1 Then Denosumab in Period 2|Alendronate 70 mg orally once a week for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
412755|NCT00518531|P2|Participant Flow|Denosumab in Period 1 Then Alendronate in Period 2|Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
412756|NCT00518531|P1|Participant Flow|Alendronate in Period 1 Then Denosumab in Period 2|Alendronate 70 mg orally once a week (QW) for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
412757|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412758|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412759|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
412760|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412761|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
412762|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412763|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
412764|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412765|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
412766|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412767|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412768|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412769|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412770|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412771|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412772|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412773|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
412774|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412775|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
412776|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412777|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
412778|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412779|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
412780|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412781|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
412782|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412783|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
412784|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
412785|NCT00518531|E4|Reported Event|Treatment Period 2: Denosumab|Participants who received alendronate 70 mg orally once a week in year 1 then received denosumab 60 mg subcutaneously every 6 months in year 2.
412786|NCT00518531|E3|Reported Event|Treatment Period 2: Alendronate|Participants who received denosumab 60 mg subcutaneously every 6 months in year 1 then received alendronate 70 mg orally once a week in year 2.
412787|NCT00518531|E2|Reported Event|Treatment Period 1: Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months in year 1.
412800|NCT00518622|P6|Participant Flow|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.
Patients received 125 mg of MK7009 on the morning of Day 8."
412801|NCT00518622|P5|Participant Flow|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412802|NCT00518622|P4|Participant Flow|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412803|NCT00518622|P3|Participant Flow|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412804|NCT00518622|P2|Participant Flow|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412805|NCT00518622|P1|Participant Flow|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412806|NCT00518622|O8|Outcome|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
412807|NCT00518622|O7|Outcome|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
412808|NCT00518622|O6|Outcome|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.
Patients received 125 mg of MK7009 on the morning of Day 8."
412809|NCT00518622|O5|Outcome|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412810|NCT00518622|O4|Outcome|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412811|NCT00518622|O3|Outcome|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412812|NCT00518622|O2|Outcome|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412813|NCT00518622|O1|Outcome|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412814|NCT00518622|O8|Outcome|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
412815|NCT00518622|O7|Outcome|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
412816|NCT00518622|O6|Outcome|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.
Patients received 125 mg of MK7009 on the morning of Day 8."
412817|NCT00518622|O5|Outcome|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412818|NCT00518622|O4|Outcome|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412819|NCT00518622|O3|Outcome|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412820|NCT00518622|O2|Outcome|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412821|NCT00518622|O1|Outcome|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412822|NCT00518622|E8|Reported Event|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
412823|NCT00518622|E7|Reported Event|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
412824|NCT00518622|E6|Reported Event|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.
Patients received 125 mg of MK7009 on the morning of Day 8."
412825|NCT00518622|E5|Reported Event|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412826|NCT00518622|E4|Reported Event|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412827|NCT00518622|E3|Reported Event|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412828|NCT00518622|E2|Reported Event|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412829|NCT00518622|E1|Reported Event|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
412830|NCT00518687|B3|Baseline|Total|Total of all reporting groups
412831|NCT00518687|B2|Baseline|Placebo|Placebo : 0.5-ml single injection of matching placebo
412832|NCT00518687|B1|Baseline|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
412833|NCT00518687|P2|Participant Flow|Placebo|Placebo : 0.5-ml single injection of matching placebo
412834|NCT00518687|P1|Participant Flow|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
412835|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
412836|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
412837|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
412838|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
412839|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
412840|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
412841|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
412863|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412864|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412868|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412869|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412870|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
412871|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412872|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412873|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412874|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
412875|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412876|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412877|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412878|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
412879|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412880|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412881|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412882|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
412883|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412884|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412885|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412886|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
412887|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412888|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412889|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412890|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
412891|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412892|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412893|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412894|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
412895|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412896|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412897|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412898|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
412899|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412900|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412901|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412902|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
412903|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412904|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412905|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412906|NCT00518713|E4|Reported Event|Placebo|tablets; orally; daily for 15-18 weeks
412907|NCT00518713|E3|Reported Event|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
412908|NCT00518713|E2|Reported Event|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
412909|NCT00518713|E1|Reported Event|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
412910|NCT00518882|B3|Baseline|Total|Total of all reporting groups
412911|NCT00518882|B2|Baseline|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412912|NCT00518882|B1|Baseline|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412913|NCT00518882|P2|Participant Flow|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412914|NCT00518882|P1|Participant Flow|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412915|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412916|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413195|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
412917|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413198|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
412918|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412919|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412920|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412921|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412922|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412923|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412924|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412925|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412926|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412927|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412928|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412929|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412930|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412931|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412932|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412933|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412934|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412935|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412936|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412937|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412938|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412939|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413196|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
412940|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412941|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412942|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412943|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412944|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412945|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412946|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412947|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412948|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412949|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412950|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412951|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412952|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412953|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412954|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412955|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412956|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412957|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412958|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412959|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412960|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412961|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412962|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413605|NCT00513357|E2|Reported Event|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
430393|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
412963|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412964|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412965|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412966|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412967|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412968|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412969|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412970|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412971|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412972|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412973|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412974|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412975|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412976|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412977|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412978|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412979|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412980|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412981|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412982|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412983|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412984|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412985|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413197|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
412986|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412987|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412988|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412989|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412990|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412991|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412992|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412993|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412994|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412995|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412996|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412997|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412998|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
412999|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413000|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413001|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413002|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413003|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413004|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413005|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413006|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413007|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413008|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413284|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413009|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413010|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413011|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413012|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413013|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413014|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413015|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413016|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413017|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413018|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413019|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413020|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413021|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413022|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413023|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413024|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413025|NCT00518882|E2|Reported Event|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413026|NCT00518882|E1|Reported Event|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
413027|NCT00518986|B3|Baseline|Total|Total of all reporting groups
413028|NCT00518986|B2|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413029|NCT00518986|B1|Baseline|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413173|NCT00519194|E1|Reported Event|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
413174|NCT00519285|B3|Baseline|Total|Total of all reporting groups
413319|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413199|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413030|NCT00518986|P2|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413031|NCT00518986|P1|Participant Flow|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413032|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413033|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413034|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413035|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413036|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413037|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413038|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413039|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413040|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413041|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413175|NCT00519285|B2|Baseline|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413176|NCT00519285|B1|Baseline|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413606|NCT00513357|E1|Reported Event|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
413042|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413043|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413044|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413045|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413046|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413047|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413048|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413049|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413050|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413051|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413052|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413053|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413177|NCT00519285|P2|Participant Flow|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413178|NCT00519285|P1|Participant Flow|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413607|NCT00513370|B1|Baseline|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
413054|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413055|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413056|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413057|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413058|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413059|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413060|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413061|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413062|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413063|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413064|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413065|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413179|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413180|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413608|NCT00513370|P1|Participant Flow|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
413066|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413067|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413068|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413069|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413070|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413071|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413072|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413073|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413074|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413075|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413076|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413077|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413181|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413182|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413609|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
413078|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413079|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413080|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413081|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413082|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413083|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413084|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413085|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413086|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413087|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413088|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413089|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413183|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413184|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413610|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413090|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413091|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413092|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413093|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413094|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413095|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413096|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413097|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413098|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413099|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413100|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413101|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413185|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413186|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413611|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
413102|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413103|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413104|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413105|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413106|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413107|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413108|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413109|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413110|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413111|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413112|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413113|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413187|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413188|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413612|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413114|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413115|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413116|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413117|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413118|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413119|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413120|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413121|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413122|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413123|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413124|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413125|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413189|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413190|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413613|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
413126|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413127|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413128|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413129|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413130|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413131|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413132|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413133|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413134|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413135|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413136|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413137|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413191|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413192|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413614|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413138|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413139|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413140|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413141|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413142|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413143|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413144|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413145|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413146|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413147|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413148|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413149|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413193|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413194|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413615|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
413150|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413151|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413152|NCT00518986|E2|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
413153|NCT00518986|E1|Reported Event|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
413154|NCT00519077|B1|Baseline|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
413155|NCT00519077|P1|Participant Flow|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
413156|NCT00519077|O1|Outcome|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
413157|NCT00519077|O1|Outcome|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
413158|NCT00519077|E1|Reported Event|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
413159|NCT00519090|B3|Baseline|Total|Total of all reporting groups
413160|NCT00519090|B2|Baseline|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
413161|NCT00519090|B1|Baseline|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
413162|NCT00519090|P2|Participant Flow|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
413163|NCT00519090|P1|Participant Flow|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
413164|NCT00519090|O2|Outcome|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
413165|NCT00519090|O1|Outcome|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
413166|NCT00519090|O2|Outcome|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
413167|NCT00519090|O1|Outcome|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
413168|NCT00519090|E2|Reported Event|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
413169|NCT00519090|E1|Reported Event|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
413170|NCT00519194|B1|Baseline|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
413171|NCT00519194|P1|Participant Flow|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
Surgical ablation of permanent AF: Concomitant AF ablation during mitral,aortic, and or tricuspid valve surgery, PFO closure or CABG procedure"
413172|NCT00519194|O1|Outcome|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
430394|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
413200|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413201|NCT00519285|E2|Reported Event|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413202|NCT00519285|E1|Reported Event|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
413203|NCT00519376|B1|Baseline|GW642444M(25,50 and 100 µg),GW642444H(100 µg), PB in 1-16 Seq|Participants were administered single dose of four of the five following treatments: GW642444M (25, 50 and 100 µg), GW642444H (100 µg) or placebo. Each participant received doses of GW642444M in an ascending dose manner with GW642444H and placebo randomly interspersed as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413204|NCT00519376|P16|Participant Flow|Seq 16: GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg, PB|Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413205|NCT00519376|P15|Participant Flow|Seq 15: GW642444H 100 µg, GW642444M 25 µg, PB, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413206|NCT00519376|P14|Participant Flow|Seq 14: GW642444H 100 µg, PB, GW642444M 25 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444H 100 µg, Placebo, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413207|NCT00519376|P13|Participant Flow|Seq 13: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413208|NCT00519376|P12|Participant Flow|Seq 12: GW642444M 25 µg, GW642444H 100 µg, PB, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413209|NCT00519376|P11|Participant Flow|Seq 11: PB, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: Placebo, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413210|NCT00519376|P10|Participant Flow|Seq 10: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413211|NCT00519376|P9|Participant Flow|Seq 9: GW642444M 25 µg, PB, GW642444H 100 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413212|NCT00519376|P8|Participant Flow|Seq 8: PB, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413213|NCT00519376|P7|Participant Flow|Seq 7: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444H 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413214|NCT00519376|P6|Participant Flow|Seq 6: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444H 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413215|NCT00519376|P5|Participant Flow|Seq 5: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg|Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413216|NCT00519376|P4|Participant Flow|Seq 4: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413217|NCT00519376|P3|Participant Flow|Seq 3: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444M 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
430395|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
413218|NCT00519376|P2|Participant Flow|Seq 2: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444M 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413219|NCT00519376|P1|Participant Flow|Seq 1: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg|Participants were administered single dose of the following treatments: Placebo (PB), GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg. Each participants received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413220|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413221|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413222|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413223|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413224|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413225|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413226|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413227|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413228|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413229|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413230|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413231|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413232|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413233|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413234|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413235|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413236|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413237|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413238|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413239|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413240|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413241|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413242|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413243|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413244|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413245|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413246|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413247|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413248|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413249|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413616|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413250|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413251|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413252|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413253|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413254|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413255|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413256|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413257|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413258|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413259|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413260|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413261|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413262|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413263|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413264|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413265|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413266|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413267|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413268|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413269|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413270|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413271|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413272|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413273|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413274|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413275|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413276|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413277|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413278|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413279|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413280|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413281|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413282|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413283|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
430396|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
413285|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413286|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413287|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413288|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413289|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413290|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413291|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413292|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413293|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413294|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413295|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413296|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413297|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413298|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413299|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413300|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413301|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413302|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413303|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413304|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413305|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413306|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413307|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413308|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413309|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413310|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413311|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413312|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413313|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413314|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413315|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413316|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413317|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413318|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
430397|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
413320|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413321|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413322|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413323|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413324|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413325|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413326|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413327|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413328|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413329|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413330|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413331|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413332|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413333|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413334|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413335|NCT00519376|E5|Reported Event|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413336|NCT00519376|E4|Reported Event|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413337|NCT00519376|E3|Reported Event|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413338|NCT00519376|E2|Reported Event|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413339|NCT00519376|E1|Reported Event|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
413340|NCT00519532|B1|Baseline|Rotigotine|Rotigotine Transdermal Patch
413341|NCT00519532|P1|Participant Flow|Rotigotine|Rotigotine Transdermal Patch
413342|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
413343|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
413344|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
413345|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
413346|NCT00519532|E1|Reported Event|Rotigotine|Rotigotine Transdermal Patch
413347|NCT00519584|B5|Baseline|Total|Total of all reporting groups
413348|NCT00519584|B4|Baseline|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413349|NCT00519584|B3|Baseline|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%"
413350|NCT00519584|B2|Baseline|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)"
413351|NCT00519584|B1|Baseline|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413352|NCT00519584|P4|Participant Flow|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413353|NCT00519584|P3|Participant Flow|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%"
413354|NCT00519584|P2|Participant Flow|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)"
413617|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
430398|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
413355|NCT00519584|P1|Participant Flow|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413937|NCT00522951|B1|Baseline|Entire Study Population|includes all participants received treatment
413356|NCT00519584|O4|Outcome|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413357|NCT00519584|O3|Outcome|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%"
413358|NCT00519584|O2|Outcome|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)"
413359|NCT00519584|O1|Outcome|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413360|NCT00519584|O4|Outcome|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413361|NCT00519584|O3|Outcome|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%"
413362|NCT00519584|O2|Outcome|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)"
413363|NCT00519584|O1|Outcome|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413364|NCT00519584|O4|Outcome|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413365|NCT00519584|O3|Outcome|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%"
413366|NCT00519584|O2|Outcome|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)"
413367|NCT00519584|O1|Outcome|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413368|NCT00519584|O4|Outcome|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413369|NCT00519584|O3|Outcome|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%"
413370|NCT00519584|O2|Outcome|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)"
413371|NCT00519584|O1|Outcome|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413372|NCT00519584|E4|Reported Event|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Bupivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413373|NCT00519584|E3|Reported Event|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
dex: 8 mg (2 ml)
Bupivacaine: 30 ml 0.5%"
413374|NCT00519584|E2|Reported Event|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
Ropivacaine: 30 ml 0.5%
dex: 8 mg (2 ml)"
413375|NCT00519584|E1|Reported Event|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
Ropivacaine: 30 ml 0.5%
Saline: 0.9% saline; systemic and local"
413376|NCT00519623|B1|Baseline|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
413377|NCT00519623|P1|Participant Flow|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
413378|NCT00519623|O1|Outcome|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
413379|NCT00519623|O1|Outcome|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
413380|NCT00519623|E1|Reported Event|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
413381|NCT00519636|B5|Baseline|Total|Total of all reporting groups
413382|NCT00519636|B4|Baseline|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
413618|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413624|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413625|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
413383|NCT00519636|B3|Baseline|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
413384|NCT00519636|B2|Baseline|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
413385|NCT00519636|B1|Baseline|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
413386|NCT00519636|P4|Participant Flow|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
413387|NCT00519636|P3|Participant Flow|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
413388|NCT00519636|P2|Participant Flow|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
413389|NCT00519636|P1|Participant Flow|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
413390|NCT00519636|O3|Outcome|Total|All Subjects on both arms preference.
413391|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
413392|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
413393|NCT00519636|O3|Outcome|Total|All Subjects on both arms preference.
413394|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
413395|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
413396|NCT00519636|O3|Outcome|Total|All subjects on both arms preference.
413397|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
413398|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
413399|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
413400|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
413401|NCT00519636|O2|Outcome|Placebo FF/FP|Subjects who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
413402|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
413403|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
413404|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
413405|NCT00519636|O2|Outcome|Placebo FF/FP|Subjects who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
413406|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
413407|NCT00519636|O3|Outcome|Total|All subjects on both arms preference.
413408|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
413619|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
413620|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413409|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
413410|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
413411|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
413412|NCT00519636|O2|Outcome|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
413413|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
413414|NCT00519636|E4|Reported Event|Placebo -FP|Subject who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
413415|NCT00519636|E3|Reported Event|Placebo - FF|Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
413416|NCT00519636|E2|Reported Event|Fluticasone Propionate Nasal Spray|Subjects who receive Fluticasone Propionate Nasal Spray.
413417|NCT00519636|E1|Reported Event|Fluticasone Furoate Nasal Spray|Subjects who received Fluticasone Furoate.
413418|NCT00519649|B1|Baseline|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
413419|NCT00519649|P1|Participant Flow|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
413420|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
413421|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
413422|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
413423|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
413424|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
413425|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
413426|NCT00519649|E1|Reported Event|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
413427|NCT00519779|B3|Baseline|Total|Total of all reporting groups
413428|NCT00519779|B2|Baseline|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
413429|NCT00519779|B1|Baseline|Placebo|Placebo oral Omega-3 fish oil supplementation
413430|NCT00519779|P2|Participant Flow|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
413431|NCT00519779|P1|Participant Flow|Placebo|Placebo oral Omega-3 fish oil supplementation
413432|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
413433|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
413434|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
413435|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
413436|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
413437|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
413438|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
413439|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
413440|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
413441|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
413442|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
413443|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
413444|NCT00519779|E2|Reported Event|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
413445|NCT00519779|E1|Reported Event|Placebo|Placebo oral Omega-3 fish oil supplementation
413446|NCT00519818|B1|Baseline|Cortef Then Chronocort|Hydrocortisone immediate release 3 times daily total dose 30mg for 7 days, then hydrocortisone modified release tablet 30mg once nightly for 28days
413447|NCT00519818|P1|Participant Flow|Cortef Then Chronocort|Hydrocortisone immediate release tablet treatment then Modified release hydrocortisone
413448|NCT00519818|O2|Outcome|Chronocort|Hydrocortisone modified release tablet treatment
413449|NCT00519818|O1|Outcome|Cortef|Hydrocortisone immediate release tablet
413450|NCT00519818|O2|Outcome|Chronocort|Hydrocortisone modified release tablet treatment
413451|NCT00519818|O1|Outcome|Cortef|Hydrocortisone immediate release tablet
413452|NCT00519818|E2|Reported Event|Cortef|Hydrocortisone immediate release tablet
413453|NCT00519818|E1|Reported Event|Chronocort|Hydrocortisone modified release tablet
430399|NCT00561600|E2|Reported Event|Pinnacle Acetabular Cup System|
413454|NCT00519831|B1|Baseline|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly
vinflunine: Vinflunine 320 mg/m² every 21 days"
413455|NCT00519831|P1|Participant Flow|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly
vinflunine: Vinflunine 320 mg/m² every 21 days"
413456|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly
vinflunine: Vinflunine 320 mg/m² every 21 days"
413457|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly
vinflunine: Vinflunine 320 mg/m² every 21 days"
413458|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly
vinflunine: Vinflunine 320 mg/m² every 21 days"
413459|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly
vinflunine: Vinflunine 320 mg/m² every 21 days"
413460|NCT00519831|E1|Reported Event|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly
vinflunine: Vinflunine 320 mg/m² every 21 days"
413461|NCT00519896|B1|Baseline|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO"
413462|NCT00519896|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO"
413463|NCT00519896|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO"
413464|NCT00519896|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO"
413465|NCT00519896|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO"
413466|NCT00519896|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given PO"
413467|NCT00520013|B4|Baseline|Total|Total of all reporting groups
413468|NCT00520013|B3|Baseline|Carboplatin/Paclitaxel/Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation: None
bevacizumab
paclitaxel
carboplatin"
413469|NCT00520013|B2|Baseline|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.
bevacizumab
erlotinib
paclitaxel
carboplatin"
413470|NCT00520013|B1|Baseline|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.
bevacizumab
paclitaxel
carboplatin"
413471|NCT00520013|P3|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation: None"
413533|NCT00513019|E1|Reported Event|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
413472|NCT00520013|P2|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
413473|NCT00520013|P1|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
413474|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
413475|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
413476|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
413477|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
413478|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
413479|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
413480|NCT00520013|E2|Reported Event|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
413481|NCT00520013|E1|Reported Event|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
413482|NCT00520130|B3|Baseline|Total|Total of all reporting groups
413483|NCT00520130|B2|Baseline|Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413484|NCT00520130|B1|Baseline|Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413485|NCT00520130|P2|Participant Flow|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413486|NCT00520130|P1|Participant Flow|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab: 375 mg/m2 intravenous (IV), day 1 for patients (pts) with cluster of differentiation 20-positive disease. Allogenic stem cell transplant (txplt). Fludarabine:30 mg/m2 per day IV over 30 min. daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV over 2 hrs on Days 6, -5, -4, -3. Mesna:1200 mg/m2 per day IV, Daily on days 6, -5,-4, and -3.Tacrolimus: day -3 before txplt, 0.02 mg/kg/day CIV, then switch to an equivalent oral dose (when pts taking po) titrated for a goal level of 5-10 ng/ml; Sirolimus: loading dose of 12 mg p.o. on day -3 pre-txplt, 4 mg day -2 pre-txplt and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post txplt). Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-txplt as tolerated. Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5.Cytarabine: 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hrs before chemo.
413487|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413488|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|"TMS Arm Rituximab: 375 mg/m2 IV, day 1 for patients with cluster of differentiation 20 (CD20)-positive disease Allogenic stem cell transplant (ASCT):Allogenic stem cell transplant Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily. On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna:1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 TMS: Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11 Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.
FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy"
413489|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413490|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|"TMS Arm Rituximab: 375 mg/m2 IV, day 1 for patients with cluster of differentiation 20 (CD20)-positive disease Allogenic stem cell transplant (ASCT):Allogenic stem cell transplant Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily. On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna:1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 TMS: Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11 Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.
FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy"
413491|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413534|NCT00513071|B1|Baseline|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies"
413621|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
413492|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|"TMS Arm Rituximab: 375 mg/m2 IV, day 1 for patients with cluster of differentiation 20 (CD20)-positive disease Allogenic stem cell transplant (ASCT):Allogenic stem cell transplant Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily. On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna:1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 TMS: Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11 Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.
FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy"
413493|NCT00520130|O2|Outcome|B - Cyclosporine (C) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413494|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413495|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413496|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413497|NCT00520130|O2|Outcome|B - Cyclosporine (C) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413498|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413535|NCT00513071|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies"
413622|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413499|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413500|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413501|NCT00520130|O2|Outcome|B - Cyclosporine (AC Arm)|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413502|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413503|NCT00520130|O2|Outcome|B - Cyclosporine (AC Arm)|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413504|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413505|NCT00520130|O2|Outcome|B - Cyclosporine (AC Arm)|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413536|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies"
413623|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
413506|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413507|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413508|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413509|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413510|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413511|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413512|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab: 375 mg/m2 intravenous (IV), day 1 for patients (pts) with cluster of differentiation 20-positive disease. Allogenic stem cell transplant (txplt). Fludarabine:30 mg/m2 per day IV over 30 min. daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV over 2 hrs on Days 6, -5, -4, -3. Mesna:1200 mg/m2 per day IV, Daily on days 6, -5,-4, and -3.Tacrolimus: day -3 before txplt, 0.02 mg/kg/day CIV, then switch to an equivalent oral dose (when pts taking po) titrated for a goal level of 5-10 ng/ml; Sirolimus: loading dose of 12 mg p.o. on day -3 pre-txplt, 4 mg day -2 pre-txplt and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post txplt). Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-txplt as tolerated. Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5.Cytarabine: 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hrs before chemo.
413537|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies"
413928|NCT00522925|P3|Participant Flow|3- PS433540 500mg|500mg once daily for 4 weeks
413513|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413514|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab: 375 mg/m2 intravenous (IV), day 1 for patients (pts) with cluster of differentiation 20-positive disease. Allogenic stem cell transplant (txplt). Fludarabine:30 mg/m2 per day IV over 30 min. daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV over 2 hrs on Days 6, -5, -4, -3. Mesna:1200 mg/m2 per day IV, Daily on days 6, -5,-4, and -3.Tacrolimus: day -3 before txplt, 0.02 mg/kg/day CIV, then switch to an equivalent oral dose (when pts taking po) titrated for a goal level of 5-10 ng/ml; Sirolimus: loading dose of 12 mg p.o. on day -3 pre-txplt, 4 mg day -2 pre-txplt and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post txplt). Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-txplt as tolerated. Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5.Cytarabine: 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hrs before chemo.
413515|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413516|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413517|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413518|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413519|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413538|NCT00513071|E1|Reported Event|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies"
413539|NCT00513240|B3|Baseline|Total|Total of all reporting groups
413520|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413521|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
413522|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
413523|NCT00520130|E2|Reported Event|B - Cyclosporine (AC) Arm|"AC Arm
Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease
Cyclosporine: Cyclosporine: IV over 2 hours or orally every 12 hours on days -1 to 100, followed by a taper if GVHD does not develop.
Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant
Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3
FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy EPOCH-F: Fludarabine:25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4 Etoposide :50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4 Doxorubicin:10 mg/m2/d"
413524|NCT00520130|E1|Reported Event|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|"TMS Arm
Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease
Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant
Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3
TMS: Tacrolimus: 0.02 mg/kg , start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.
FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy"
413525|NCT00513019|B3|Baseline|Total|Total of all reporting groups
413526|NCT00513019|B2|Baseline|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
413527|NCT00513019|B1|Baseline|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
413528|NCT00513019|P2|Participant Flow|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
413529|NCT00513019|P1|Participant Flow|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
413530|NCT00513019|O2|Outcome|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
413531|NCT00513019|O1|Outcome|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
413532|NCT00513019|E2|Reported Event|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
413592|NCT00513344|O3|Outcome|Dark Chocolate Containing Polyphenols|"dark chocolate
Dark Chocolate : 1 portion"
413593|NCT00513344|O2|Outcome|Milk Chocolate Containing Polyphenols|"Bespoke milk chocolate
Milk Chocolate : 1 portion"
413540|NCT00513240|B2|Baseline|Control Group.|"Patients randomized to receive 3 doses of normal saline control.
Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
413541|NCT00513240|B1|Baseline|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.
Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
413542|NCT00513240|P2|Participant Flow|Control Group.|"Patients randomized to receive 3 doses of normal saline control.
Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
413543|NCT00513240|P1|Participant Flow|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.
Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
413544|NCT00513240|O3|Outcome|Placebo|Placebo
413545|NCT00513240|O2|Outcome|EPO 500 Units/kg QODx3|Revised dose after FDA clinical hold removed of EPO 500 units/kg every other day for 3 doses
413546|NCT00513240|O1|Outcome|EPO 1000 Units/kg QDx3|Original dose of 1000 units/kg every day for 3 doses
413547|NCT00513240|E2|Reported Event|Control Group.|"Patients randomized to receive 3 doses of normal saline control.
Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
413548|NCT00513240|E1|Reported Event|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.
Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
413549|NCT00513292|B3|Baseline|Total|Total of all reporting groups
413550|NCT00513292|B2|Baseline|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413551|NCT00513292|B1|Baseline|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413552|NCT00513292|P2|Participant Flow|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413553|NCT00513292|P1|Participant Flow|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413554|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413555|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413594|NCT00513344|O1|Outcome|Control Chocolate With no Polyphenols|"cocoa-free chocolate
Control (polyphenol-free)"
413595|NCT00513344|E3|Reported Event|Control|
413596|NCT00513344|E2|Reported Event|Milk Chocolate|
413597|NCT00513344|E1|Reported Event|Dark Chocolate|
413556|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413557|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413558|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413559|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413560|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413561|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413562|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413563|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413564|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413598|NCT00513357|B3|Baseline|Total|Total of all reporting groups
413599|NCT00513357|B2|Baseline|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
413600|NCT00513357|B1|Baseline|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
413565|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413566|NCT00513292|E2|Reported Event|Arm B|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413567|NCT00513292|E1|Reported Event|Arm A|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
413568|NCT00513305|B3|Baseline|Total|Total of all reporting groups
413569|NCT00513305|B2|Baseline|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
413570|NCT00513305|B1|Baseline|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
413571|NCT00513305|P2|Participant Flow|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
413572|NCT00513305|P1|Participant Flow|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
413573|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
413601|NCT00513357|P2|Participant Flow|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
413574|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
413575|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
413576|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
413577|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
413578|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
413579|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
413580|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
413602|NCT00513357|P1|Participant Flow|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
413603|NCT00513357|O2|Outcome|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
413604|NCT00513357|O1|Outcome|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
430400|NCT00561600|E1|Reported Event|ASR XL Acetabular Cup System|
413581|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
413582|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
413583|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
413584|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
413585|NCT00513305|E2|Reported Event|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
413586|NCT00513305|E1|Reported Event|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
413587|NCT00513344|B1|Baseline|Entire Study Population|Includes groups randomized to receive control first, milk chocolate first, and dark chocolate first
413588|NCT00513344|P1|Participant Flow|Each Subject Tested the Three Products Randomly Following|"Before the 1st intervention, no food with polyphenols was admitted
Each subject was administered the three products randomly(one product per one-day intervention) according to the six possible sequencies:
Either dark chocolate first, then milk chocolate then control
or dark chocolate first, then control, then milk chocolate
or control first, then dark chocolate, then milk chocolate
or Control first, then milk chocolate, then dark chocolate
or Milk chocolate first, then control, then dark chocolate
or milk chocolate first, then dark chocolate, then control r dark chocolate was given once in the morning (1 day) Products were administered in the morning of the testing day. The testing days (interventions) were separated by a three-day wash-out period."
413589|NCT00513344|O3|Outcome|Dark Chocolate Containing Polyphenols|"dark chocolate
Dark Chocolate : 1 portion"
413590|NCT00513344|O2|Outcome|Milk Chocolate Containing Polyphenols|"Bespoke milk chocolate
Milk Chocolate : 1 portion"
413591|NCT00513344|O1|Outcome|Control Chocolate With no Polyphenols|"cocoa-free chocolate
Control (polyphenol-free)"
430401|NCT00561652|B3|Baseline|Total|Total of all reporting groups
413626|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413627|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
413628|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413629|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413630|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413631|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
413632|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413633|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
413634|NCT00513370|E1|Reported Event|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
413635|NCT00513409|B3|Baseline|Total|Total of all reporting groups
413636|NCT00513409|B2|Baseline|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413637|NCT00513409|B1|Baseline|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413638|NCT00513409|P2|Participant Flow|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413639|NCT00513409|P1|Participant Flow|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413640|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413641|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413642|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413643|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413644|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413645|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413646|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413647|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413648|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413649|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413650|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413651|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413652|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413653|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413654|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413655|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413656|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413657|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413658|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413840|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
413659|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413660|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413661|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413662|NCT00513409|E2|Reported Event|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413663|NCT00513409|E1|Reported Event|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
413664|NCT00513435|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
413665|NCT00513435|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib 175 mg PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
413666|NCT00513435|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
413667|NCT00513435|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
413668|NCT00513435|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
413669|NCT00513474|B3|Baseline|Total|Total of all reporting groups
413670|NCT00513474|B2|Baseline|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
413671|NCT00513474|B1|Baseline|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
413672|NCT00513474|P2|Participant Flow|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
413673|NCT00513474|P1|Participant Flow|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
413674|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
413675|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
413676|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
413677|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
413678|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
413695|NCT00513500|E2|Reported Event|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Refer children with pneumonia to the nearest health facility."
413841|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
413846|NCT00520299|E3|Reported Event|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects who received 160 IU/m^2/week of ADI-PEG 20
413679|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
413680|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
413681|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
413682|NCT00513474|E2|Reported Event|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
413683|NCT00513474|E1|Reported Event|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
413684|NCT00513500|B3|Baseline|Total|Total of all reporting groups
413685|NCT00513500|B2|Baseline|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Refer children with pneumonia to the nearest health facility."
413686|NCT00513500|B1|Baseline|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:
Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
413687|NCT00513500|P2|Participant Flow|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Refer children with pneumonia to the nearest health facility."
413688|NCT00513500|P1|Participant Flow|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:
Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
413689|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Refer children with pneumonia to the nearest health facility."
413690|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:
Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
413691|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Refer children with pneumonia to the nearest health facility."
413692|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:
Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
413693|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Refer children with pneumonia to the nearest health facility."
413694|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:
Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
413842|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
413696|NCT00513500|E1|Reported Event|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:
Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.
Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
413697|NCT00513526|B1|Baseline|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
413698|NCT00513526|P1|Participant Flow|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
413699|NCT00513526|O1|Outcome|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
413700|NCT00513526|O1|Outcome|Gardasil|
413701|NCT00513526|O1|Outcome|Gardasil|
413702|NCT00513526|O1|Outcome|Gardasil|
413703|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
413704|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
413705|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
413706|NCT00513526|O1|Outcome|Gardasil|
413707|NCT00513526|O1|Outcome|Gardasil|
413708|NCT00513526|O1|Outcome|Gardasil|
413709|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
413710|NCT00513526|O1|Outcome|Gardasil|
413711|NCT00513526|E1|Reported Event|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
413712|NCT00513604|B6|Baseline|Total|Total of all reporting groups
413713|NCT00513604|B5|Baseline|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
413714|NCT00513604|B4|Baseline|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413715|NCT00513604|B3|Baseline|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413716|NCT00513604|B2|Baseline|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413717|NCT00513604|B1|Baseline|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413718|NCT00513604|P5|Participant Flow|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
413719|NCT00513604|P4|Participant Flow|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413720|NCT00513604|P3|Participant Flow|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413843|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
431223|NCT00553267|O1|Outcome|Amlodipine 10mg|
413721|NCT00513604|P2|Participant Flow|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413722|NCT00513604|P1|Participant Flow|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413723|NCT00513604|O5|Outcome|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
413724|NCT00513604|O4|Outcome|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413725|NCT00513604|O3|Outcome|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413726|NCT00513604|O2|Outcome|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413727|NCT00513604|O1|Outcome|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413728|NCT00513604|O5|Outcome|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
413729|NCT00513604|O4|Outcome|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413730|NCT00513604|O3|Outcome|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413731|NCT00513604|O2|Outcome|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413732|NCT00513604|O1|Outcome|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413760|NCT00513682|E3|Reported Event|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
413733|NCT00513604|E5|Reported Event|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
413734|NCT00513604|E4|Reported Event|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413735|NCT00513604|E3|Reported Event|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413736|NCT00513604|E2|Reported Event|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413737|NCT00513604|E1|Reported Event|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
413738|NCT00513617|B4|Baseline|Total|Total of all reporting groups
413739|NCT00513617|B3|Baseline|Placebo|
413740|NCT00513617|B2|Baseline|High Dose|0.10 g/kg/day of Arginine in capsule form
413741|NCT00513617|B1|Baseline|Low Dose|0.05 g/kg/day of Arginine in capsule form
413742|NCT00513617|P3|Participant Flow|Placebo|
413743|NCT00513617|P2|Participant Flow|High Dose|0.10 g/kg/day of Arginine in capsule form
413744|NCT00513617|P1|Participant Flow|Low Dose|0.05 g/kg/day of Arginine in capsule form
413745|NCT00513617|O3|Outcome|Placebo|
413746|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
413747|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
413748|NCT00513617|O3|Outcome|Placebo|
413749|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
413750|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
413751|NCT00513617|O3|Outcome|Placebo|
413752|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
413753|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
413754|NCT00513682|B1|Baseline|Ultrase® MT20|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet. Then the treatment phase was started which consisted of a stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
413755|NCT00513682|P1|Participant Flow|Ultrase® MT20|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet. Then the treatment phase was started which consisted of a stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
413756|NCT00513682|O2|Outcome|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
413757|NCT00513682|O1|Outcome|Ultrase® MT20 Washout Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet.
413758|NCT00513682|O2|Outcome|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
413759|NCT00513682|O1|Outcome|Ultrase® MT20 Washout Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet.
413929|NCT00522925|P2|Participant Flow|2- PS433540 200mg|200mg daily for 4 weeks
413761|NCT00513682|E2|Reported Event|Ultrase® MT20 Washout Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent a washout phase, of 6 to 7 days, in which participants received only high-fat diet and refrained from taking Ultrase® MT20.
413762|NCT00513682|E1|Reported Event|Ultrase® MT20 Screening Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea.
413763|NCT00513695|B1|Baseline|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
sunitinib malate: Given PO
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
filgrastim: Given SC
therapeutic conventional surgery: Undergo surgery
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies"
413764|NCT00513695|P1|Participant Flow|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
sunitinib malate: Given PO
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
filgrastim: Given SC
therapeutic conventional surgery: Undergo surgery
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies"
413765|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
sunitinib malate: Given PO
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
filgrastim: Given SC
therapeutic conventional surgery: Undergo surgery
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies"
413766|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
sunitinib malate: Given PO
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
filgrastim: Given SC
therapeutic conventional surgery: Undergo surgery
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies"
413767|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
sunitinib malate: Given PO
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
filgrastim: Given SC
therapeutic conventional surgery: Undergo surgery
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies"
413768|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
sunitinib malate: Given PO
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
filgrastim: Given SC
therapeutic conventional surgery: Undergo surgery
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies"
413769|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
sunitinib malate: Given PO
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
filgrastim: Given SC
therapeutic conventional surgery: Undergo surgery
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies"
413788|NCT00513708|E3|Reported Event|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
413844|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
413845|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
413770|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
sunitinib malate: Given PO
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
filgrastim: Given SC
therapeutic conventional surgery: Undergo surgery
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies"
413771|NCT00513695|E1|Reported Event|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
sunitinib malate: Given PO
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
filgrastim: Given SC
therapeutic conventional surgery: Undergo surgery
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies"
413772|NCT00513708|B4|Baseline|Total|Total of all reporting groups
413773|NCT00513708|B3|Baseline|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
413774|NCT00513708|B2|Baseline|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
413775|NCT00513708|B1|Baseline|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
413776|NCT00513708|P3|Participant Flow|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
413777|NCT00513708|P2|Participant Flow|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
413778|NCT00513708|P1|Participant Flow|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
413779|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
413780|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
413781|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
413782|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
413783|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
413784|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
413785|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
413786|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
413787|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
413838|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
413839|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
413789|NCT00513708|E2|Reported Event|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
413790|NCT00513708|E1|Reported Event|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
413791|NCT00520234|B3|Baseline|Total|Total of all reporting groups
413792|NCT00520234|B2|Baseline|Placebo|Normal Saline 100 cc IV daily
413793|NCT00520234|B1|Baseline|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
413794|NCT00520234|P2|Participant Flow|Placebo|Normal Saline 100 cc IV daily
413795|NCT00520234|P1|Participant Flow|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
413796|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
413797|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
413798|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
413799|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
413800|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
413801|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50mg IV daily
413802|NCT00520234|E2|Reported Event|Placebo|Normal Saline 100 cc IV daily
413803|NCT00520234|E1|Reported Event|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
413804|NCT00520286|B3|Baseline|Total|Total of all reporting groups
413805|NCT00520286|B2|Baseline|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily"
413806|NCT00520286|B1|Baseline|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily"
413807|NCT00520286|P2|Participant Flow|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily"
413808|NCT00520286|P1|Participant Flow|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily"
413809|NCT00520286|O2|Outcome|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily"
413810|NCT00520286|O1|Outcome|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily"
413811|NCT00520286|O2|Outcome|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily"
413812|NCT00520286|O1|Outcome|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily"
413813|NCT00520286|E2|Reported Event|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily"
413814|NCT00520286|E1|Reported Event|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily"
413815|NCT00520299|B4|Baseline|Total|Total of all reporting groups
413816|NCT00520299|B3|Baseline|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
413817|NCT00520299|B2|Baseline|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
413818|NCT00520299|B1|Baseline|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
413819|NCT00520299|P3|Participant Flow|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
413820|NCT00520299|P2|Participant Flow|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
413821|NCT00520299|P1|Participant Flow|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
413822|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
413823|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
413824|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
413825|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
413826|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
413827|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
413828|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
413829|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
413830|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
413831|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
413832|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
413833|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
413834|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
413835|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
413836|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
413837|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
413930|NCT00522925|P1|Participant Flow|1- Placebo|Placebo
413847|NCT00520299|E2|Reported Event|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects who received 80 IU/m^2/week of ADI-PEG 20
413848|NCT00520299|E1|Reported Event|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects who received 40 IU/m^2/week of ADI-PEG 20
413849|NCT00520351|B3|Baseline|Total|Total of all reporting groups
413850|NCT00520351|B2|Baseline|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
413851|NCT00520351|B1|Baseline|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
413852|NCT00520351|P2|Participant Flow|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
413853|NCT00520351|P1|Participant Flow|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
413854|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
413855|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
413856|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
413857|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
413858|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
413859|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
413860|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
413861|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
413862|NCT00520351|E2|Reported Event|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
413863|NCT00520351|E1|Reported Event|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
413864|NCT00520403|B1|Baseline|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
413865|NCT00520403|P1|Participant Flow|Bevacizumab + Interferon Alfa-2a (IFN)/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg intravenously (IV) and bevacizumab 15 milligrams per kilogram (mg/kg) IV on Day 1 followed by 2 weeks off and IFN subcutaneous (SC) injection three times per week (starting on Day 1) at doses of 3 million International Units (mIU) (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3; the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
413884|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413931|NCT00522925|O3|Outcome|3- PS433540 500mg|500mg once daily for 4 weeks
413934|NCT00522925|E3|Reported Event|3- PS433540 500mg|500mg once daily for 4 weeks
413935|NCT00522925|E2|Reported Event|2- PS433540 200mg|200mg daily for 4 weeks
413866|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
413867|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
413868|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
413869|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
413870|NCT00520403|E1|Reported Event|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
413871|NCT00520468|B1|Baseline|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
413872|NCT00520468|P1|Participant Flow|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
413873|NCT00520468|O1|Outcome|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
413874|NCT00520468|E1|Reported Event|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
413875|NCT00520494|B1|Baseline|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413876|NCT00520494|P1|Participant Flow|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413877|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413878|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413879|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413880|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413881|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413882|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413883|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413885|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413886|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413887|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413888|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413889|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413890|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413891|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413892|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413893|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413894|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413895|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413896|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413897|NCT00520494|E1|Reported Event|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
413898|NCT00522457|B1|Baseline|Ertumaxomab|
413899|NCT00522457|P1|Participant Flow|Ertumaxomab|
413900|NCT00522457|O1|Outcome|Ertumaxomab|
413901|NCT00522457|O1|Outcome|Ertumaxomab|
413902|NCT00522457|O1|Outcome|Ertumaxomab|
413903|NCT00522457|E1|Reported Event|Ertumaxomab|
413904|NCT00522626|B1|Baseline|Observational|Opioid exposed pregnancies
413905|NCT00522626|P1|Participant Flow|Observational|Opioid exposed pregnancies
413906|NCT00522626|O1|Outcome|Trough Fetal Heart Rate|Opioid exposed pregnancies
413907|NCT00522626|E1|Reported Event|Observational|Opioid exposed pregnancies
413908|NCT00522795|B1|Baseline|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.
Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
413909|NCT00522795|P1|Participant Flow|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.
Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
413910|NCT00522795|O1|Outcome|PPX, Cisplatin, Radiation|
413911|NCT00522795|E1|Reported Event|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.
Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
413912|NCT00522873|B3|Baseline|Total|Total of all reporting groups
413913|NCT00522873|B2|Baseline|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
413914|NCT00522873|B1|Baseline|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
413915|NCT00522873|P2|Participant Flow|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
413916|NCT00522873|P1|Participant Flow|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
413917|NCT00522873|O2|Outcome|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
413918|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
413919|NCT00522873|O2|Outcome|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
413920|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
413921|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
413922|NCT00522873|E2|Reported Event|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
413923|NCT00522873|E1|Reported Event|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
413924|NCT00522925|B4|Baseline|Total|Total of all reporting groups
413925|NCT00522925|B3|Baseline|3- PS433540 500mg|500mg once daily for 4 weeks
413926|NCT00522925|B2|Baseline|2- PS433540 200mg|200mg daily for 4 weeks
413938|NCT00522951|P2|Participant Flow|Gadoteridol Then Gadobutrol|Participants who received two injections of gadoteridol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadobutrol 0.1 mmol/kg bw in Period 2
413939|NCT00522951|P1|Participant Flow|Gadobutrol Then Gadoteridol|Participants who received two injections of gadobutrol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadoteridol 0.1 mmol/kg bw in Period 2
413940|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413941|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413942|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
413943|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413944|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413945|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
413946|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413947|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413948|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
413949|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413950|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413951|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413952|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413953|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413954|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413955|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413956|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413957|NCT00522951|O1|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413958|NCT00522951|O1|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413959|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413960|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
413961|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413962|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413963|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
413964|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
414262|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
413965|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
414272|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
413966|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
413967|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413968|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413969|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
413970|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413971|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413972|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
413973|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413974|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
413975|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
413976|NCT00522951|E2|Reported Event|ProHance Period|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
413977|NCT00522951|E1|Reported Event|Gadobutrol Period|Participants received two injections (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
413978|NCT00523237|B1|Baseline|Raltegravir|400 mg twice daily
413979|NCT00523237|P1|Participant Flow|Raltegravir|400 mg twice daily
413980|NCT00523237|O1|Outcome|Enfuvirtide Switch to Raltegravir Arm|patients were switched from Enfuvirtide to Raltegravir
413981|NCT00523237|E1|Reported Event|Raltegravir|400 mg twice daily
413982|NCT00523341|B3|Baseline|Total|Total of all reporting groups
413983|NCT00523341|B2|Baseline|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
413984|NCT00523341|B1|Baseline|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
413985|NCT00523341|P2|Participant Flow|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
413986|NCT00523341|P1|Participant Flow|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
413987|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
413988|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
413989|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
413990|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
413991|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
413992|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
413993|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
413994|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
413995|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
413996|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
413997|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414263|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
413998|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
413999|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414000|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414001|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414002|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414003|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414004|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414005|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414006|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414007|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414008|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414009|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414010|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414011|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414012|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414013|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414014|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414015|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414016|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414017|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414018|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414019|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414020|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414021|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414022|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414023|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414024|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414025|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414026|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414264|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414027|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414028|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414029|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414030|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414031|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414032|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414033|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414034|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414035|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414036|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414037|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414038|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414039|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414040|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414041|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414042|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414043|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414044|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414045|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414046|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414047|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414048|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414049|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414050|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414051|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414052|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414053|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414054|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414055|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414265|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414056|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414057|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414058|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414059|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414060|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414061|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414062|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414063|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414064|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414065|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414066|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414067|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414068|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414069|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414070|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414071|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414072|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414073|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414074|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414075|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414076|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414077|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414078|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414079|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414080|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414081|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
414082|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
414083|NCT00523341|E2|Reported Event|Denosumab/ Denosumab 60 mg Q6M|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years (total of 10 years treatment).
414084|NCT00523341|E1|Reported Event|Placebo/ Denosumab 60 mg Q6M|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years.
414266|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414085|NCT00523367|B1|Baseline|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
414086|NCT00523367|P1|Participant Flow|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
414087|NCT00523367|O1|Outcome|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
414088|NCT00523367|E1|Reported Event|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
414089|NCT00523419|B1|Baseline|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
414090|NCT00523419|P1|Participant Flow|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
414091|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
414092|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
414093|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
414094|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
414095|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
414096|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
414097|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
414098|NCT00523419|E1|Reported Event|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
414099|NCT00523549|B3|Baseline|Total|Total of all reporting groups
414100|NCT00523549|B2|Baseline|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
414101|NCT00523549|B1|Baseline|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
414102|NCT00523549|P2|Participant Flow|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
414103|NCT00523549|P1|Participant Flow|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
414104|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
414143|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
414144|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
414267|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414145|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
414105|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
414106|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
414107|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
414108|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
414109|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
414110|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
414111|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
414112|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
414113|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
414114|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
414205|NCT00523978|P2|Participant Flow|Standard Treatment With Drugs Only|a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.
414115|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
414116|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
414117|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
414118|NCT00523549|E2|Reported Event|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
414119|NCT00523549|E1|Reported Event|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
414120|NCT00523614|B3|Baseline|Total|Total of all reporting groups
414121|NCT00523614|B2|Baseline|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
414122|NCT00523614|B1|Baseline|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
414123|NCT00523614|P2|Participant Flow|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
414124|NCT00523614|P1|Participant Flow|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
414125|NCT00523614|O2|Outcome|Controls|Women without a venous thromboembolism who are between 15 and 49 years old
414126|NCT00523614|O1|Outcome|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
414127|NCT00523614|E2|Reported Event|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
414128|NCT00523614|E1|Reported Event|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
414129|NCT00523640|B1|Baseline|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
414130|NCT00523640|P1|Participant Flow|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
414131|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
414132|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
414133|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
414134|NCT00523640|E1|Reported Event|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
414135|NCT00523705|B3|Baseline|Total|Total of all reporting groups
414136|NCT00523705|B2|Baseline|Sugar Pill|Placebo tablets matched to drug.
414137|NCT00523705|B1|Baseline|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
414138|NCT00523705|P2|Participant Flow|Sugar Pill|Placebo tablets matched to drug.
414139|NCT00523705|P1|Participant Flow|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
414140|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
414141|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
414142|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
414268|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414269|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414147|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
414148|NCT00523705|E2|Reported Event|Sugar Pill|Placebo tablets matched to drug.
414149|NCT00523705|E1|Reported Event|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
414150|NCT00523718|B3|Baseline|Total|Total of all reporting groups
414151|NCT00523718|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.
placebo: placebo, 1 capsule PO bid, 12 weeks"
414152|NCT00523718|B1|Baseline|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment
riluzole: 50 mg PO bid, 12 weeks"
414153|NCT00523718|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.
placebo: placebo, 1 capsule PO bid, 12 weeks"
414154|NCT00523718|P1|Participant Flow|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment
riluzole: 50 mg PO bid, 12 weeks"
414155|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.
placebo: placebo, 1 capsule PO bid, 12 weeks"
414156|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment
riluzole: 50 mg PO bid, 12 weeks"
414157|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.
placebo: placebo, 1 capsule PO bid, 12 weeks"
414158|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment
riluzole: 50 mg PO bid, 12 weeks"
414159|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.
placebo: placebo, 1 capsule PO bid, 12 weeks"
414160|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment
riluzole: 50 mg PO bid, 12 weeks"
414161|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.
placebo: placebo, 1 capsule PO bid, 12 weeks"
414162|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment
riluzole: 50 mg PO bid, 12 weeks"
414163|NCT00523718|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.
placebo: placebo, 1 capsule PO bid, 12 weeks"
414164|NCT00523718|E1|Reported Event|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment
riluzole: 50 mg PO bid, 12 weeks"
414165|NCT00523744|B1|Baseline|Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ|During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
414166|NCT00523744|P1|Participant Flow|Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ|During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
414167|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
414168|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
414169|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
414206|NCT00523978|P1|Participant Flow|Cryoablation|an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
414170|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
414171|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
414172|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
414173|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
414174|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
414175|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
414176|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
414177|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
414178|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
414179|NCT00523744|E3|Reported Event|Phase 3 - Amlodipine+Valsartan+HCTZ|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
414180|NCT00523744|E2|Reported Event|Phase 2 - Amlodipine+Valsartan|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
414181|NCT00523744|E1|Reported Event|Phase 1 - Amlodipine+Olmesartan|4 weeks treatment with amlodipine 10 mg plus olmesartan 20 mg taken orally once daily in the morning.
414182|NCT00523809|B1|Baseline|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
414183|NCT00523809|P1|Participant Flow|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
414184|NCT00523809|O1|Outcome|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
414185|NCT00523809|E1|Reported Event|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
414186|NCT00523848|B1|Baseline|VDT: VELCADE, Doxil and Low-dose Thalidomide|
414187|NCT00523848|P1|Participant Flow|Arm 1 - VDT: VELCADE, Doxil and Low-dose Thalidomide|Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
414188|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
414189|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
414190|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
414191|NCT00523848|E1|Reported Event|VDT: VELCADE, Doxil and Low-dose Thalidomide|
414192|NCT00523939|B3|Baseline|Total|Total of all reporting groups
414193|NCT00523939|B2|Baseline|Leukemic|Subjects with Leukemic Meningitis
414194|NCT00523939|B1|Baseline|Lymphomatous|Subjects with Lymphomatous Meningitis
414195|NCT00523939|P2|Participant Flow|Leukemic|Subjects with Leukemic Meningitis
414196|NCT00523939|P1|Participant Flow|Lymphomatous|Subjects with Lymphomatous Meningitis
414197|NCT00523939|O2|Outcome|Leukemic|Subjects with Leukemic Meningitis
414198|NCT00523939|O1|Outcome|Lymphomatous|Subjects with Lymphomatous Meningitis
414199|NCT00523939|O2|Outcome|Leukemic|Subjects with Leukemic Meningitis
414200|NCT00523939|O1|Outcome|Lymphomatous|Subjects with Lymphomatous Meningitis
414201|NCT00523939|E1|Reported Event|All Subjects|Subjects with Lymphomatous or Leukemic Meningitis.
414202|NCT00523978|B3|Baseline|Total|Total of all reporting groups
414203|NCT00523978|B2|Baseline|Standard Treatment With Drugs Only|a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.
414204|NCT00523978|B1|Baseline|Cryoablation|an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
431224|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
414207|NCT00523978|O1|Outcome|Cryoablation|Experimental group or group that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
414273|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414208|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
414209|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
414210|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
414211|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
414212|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
414213|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
414214|NCT00523978|O1|Outcome|Cryoablation|Experimental group or group that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
414215|NCT00523978|E2|Reported Event|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
414216|NCT00523978|E1|Reported Event|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
414217|NCT00523991|B3|Baseline|Total|Total of all reporting groups
414218|NCT00523991|B2|Baseline|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414219|NCT00523991|B1|Baseline|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414220|NCT00523991|P2|Participant Flow|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414221|NCT00523991|P1|Participant Flow|Placebo|Placebo matching tiotropium via HandiHaler® + Pro Re Nata (PRN) albuterol
414222|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414223|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414224|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414225|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414226|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414227|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414228|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414229|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414230|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414231|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414232|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414233|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414234|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414235|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414236|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414237|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414238|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414239|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414240|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414241|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414242|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414243|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414244|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414245|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414246|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414247|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414248|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414249|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414250|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414251|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414252|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414253|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414254|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414255|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414256|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414257|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414258|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414259|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414260|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414261|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
431225|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
414270|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414271|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414274|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414275|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414276|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414277|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414278|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414279|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414280|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414281|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414282|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414283|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414284|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414285|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414286|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414287|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414288|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414289|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414290|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414291|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414292|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414293|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414294|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414295|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414296|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414297|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414298|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414299|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414300|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414301|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414302|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414303|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414304|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414305|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414306|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414307|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414308|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414309|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414310|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414311|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414312|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414313|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414314|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414315|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414316|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414317|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414318|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414319|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414320|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414321|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414322|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414323|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414324|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414325|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414326|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414327|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414328|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414329|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414330|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414331|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414332|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414333|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414334|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
431226|NCT00553267|O1|Outcome|Amlodipine 10mg|
414335|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414336|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414337|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414338|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414339|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414340|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414341|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414342|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414343|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414344|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414345|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414346|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414347|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414348|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414349|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414350|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414351|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414352|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414353|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414354|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414355|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414356|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414357|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414358|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414359|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414360|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414361|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414362|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414363|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414364|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414365|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414366|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414367|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414368|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414369|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414370|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414371|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414372|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414373|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414374|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414375|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414376|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414377|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414378|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414379|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414380|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414381|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414382|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414383|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414384|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414385|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414386|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414387|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414388|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414389|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414390|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414391|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414392|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414393|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414394|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414395|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414396|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414397|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414398|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414399|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
431227|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
414400|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414401|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414402|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414403|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414404|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414405|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414406|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414407|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414408|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414409|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414410|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414411|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414412|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414413|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414414|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414415|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414416|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414417|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414418|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414419|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414420|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414421|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414422|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414423|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414424|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414425|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414426|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414427|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414428|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414429|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414430|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414431|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414432|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414433|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414434|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414435|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414436|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414437|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414438|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414439|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414440|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414441|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414442|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414443|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414444|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414445|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414446|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414447|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414448|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414449|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414450|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414451|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414452|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414453|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414454|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414455|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414456|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414457|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414458|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414459|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414460|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414461|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414462|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414463|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414464|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
431228|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
414465|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414466|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414467|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414468|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414469|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414470|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414471|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414472|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414473|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414474|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414475|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414476|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414477|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414478|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414479|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414480|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414481|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414482|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414483|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414484|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414485|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414486|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414487|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414488|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414489|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414490|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414491|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414492|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414493|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414494|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414495|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414496|NCT00523991|E2|Reported Event|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
414497|NCT00523991|E1|Reported Event|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
414498|NCT00524030|B3|Baseline|Total|Total of all reporting groups
414499|NCT00524030|B2|Baseline|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
414500|NCT00524030|B1|Baseline|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
414501|NCT00524030|P2|Participant Flow|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
414502|NCT00524030|P1|Participant Flow|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
414503|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
414504|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
414505|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
414506|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
414538|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
414539|NCT00524043|E3|Reported Event|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
414540|NCT00524043|E2|Reported Event|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
414541|NCT00524043|E1|Reported Event|Placebo|One oral placebo tablet daily for 6 weeks.
415070|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
414507|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
414508|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
414509|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
414510|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
414511|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
414512|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
414513|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
414514|NCT00524030|O1|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
414515|NCT00524030|E2|Reported Event|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
414516|NCT00524030|E1|Reported Event|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
414517|NCT00524043|B4|Baseline|Total|Total of all reporting groups
414518|NCT00524043|B3|Baseline|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
414519|NCT00524043|B2|Baseline|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
414520|NCT00524043|B1|Baseline|Placebo|One oral placebo tablet daily for 6 weeks.
414521|NCT00524043|P3|Participant Flow|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
414522|NCT00524043|P2|Participant Flow|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
414523|NCT00524043|P1|Participant Flow|Placebo|One oral placebo tablet daily for 6 weeks.
414524|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
414525|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
414526|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
414527|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
414528|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
414529|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
414530|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
414531|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
414532|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
414533|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
414534|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
414535|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
414536|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
414537|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
431229|NCT00553267|O1|Outcome|Amlodipine 10mg|
414542|NCT00524121|B1|Baseline|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
414543|NCT00524121|P1|Participant Flow|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
414544|NCT00524121|O2|Outcome|EGFR Mutation|Assessed by fluorescent in situ hybridization (FISH)
414545|NCT00524121|O1|Outcome|No EGFR Mutation|Assessed by fluorescent in situ hybridization (FISH)
414546|NCT00524121|O2|Outcome|pEGFR>20 μg/ml|Cut at median of 20 pEGFR>20 μg/ml
414547|NCT00524121|O1|Outcome|pEGFR<=20 μg/ml|Cut at median of 20 pEGFR<=20 μg/ml
414548|NCT00524121|O2|Outcome|EGFR>120 μg/ml|Cut at median of 120 EGFR>120 μg/ml
414549|NCT00524121|O1|Outcome|EGFR<=120 μg/ml|Cut at median of 120 EGFR<=120 μg/ml
414550|NCT00524121|O3|Outcome|Never Smokers|
414551|NCT00524121|O2|Outcome|Former Smokers|
414552|NCT00524121|O1|Outcome|Current Smokers|
414553|NCT00524121|O2|Outcome|Erlotinib in Combination With Radiotherapy at Week 3|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
414554|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy at Baseline|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
414555|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
414556|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
414557|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
414558|NCT00524121|E1|Reported Event|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
414559|NCT00524134|B1|Baseline|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.
Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
414560|NCT00524134|P1|Participant Flow|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.
Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
414561|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.
Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
414562|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.
Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
414563|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.
Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
414564|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.
Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
414565|NCT00524134|E1|Reported Event|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.
Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
414566|NCT00524225|B1|Baseline|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively
Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
414567|NCT00524225|P1|Participant Flow|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively
Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
414810|NCT00524771|B2|Baseline|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
414568|NCT00524225|O1|Outcome|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
414569|NCT00524225|O1|Outcome|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
414570|NCT00524225|E1|Reported Event|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
414571|NCT00524264|B3|Baseline|Total|Total of all reporting groups
414572|NCT00524264|B2|Baseline|Vehicle Solution|
414573|NCT00524264|B1|Baseline|Ketorolac Solution|
414574|NCT00524264|P2|Participant Flow|Vehicle Solution|
414575|NCT00524264|P1|Participant Flow|Ketorolac Solution|
414576|NCT00524264|O2|Outcome|Vehicle Solution|
414577|NCT00524264|O1|Outcome|Ketorolac Solution|
414578|NCT00524264|O2|Outcome|Vehicle Solution|
414579|NCT00524264|O1|Outcome|Ketorolac Solution|
414580|NCT00524264|O2|Outcome|Vehicle Solution|
414581|NCT00524264|O1|Outcome|Ketorolac Solution|
414582|NCT00524264|O2|Outcome|Vehicle Solution|
414583|NCT00524264|O1|Outcome|Ketorolac Solution|
414584|NCT00524264|E2|Reported Event|Vehicle Solution|
414585|NCT00524264|E1|Reported Event|Ketorolac Solution|
414586|NCT00524303|B4|Baseline|Total|Total of all reporting groups
414587|NCT00524303|B3|Baseline|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
414588|NCT00524303|B2|Baseline|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
414589|NCT00524303|B1|Baseline|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
414590|NCT00524303|P3|Participant Flow|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
414591|NCT00524303|P2|Participant Flow|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
414592|NCT00524303|P1|Participant Flow|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
414593|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
414594|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
414595|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
414660|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
431230|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
414661|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
456458|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
414596|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
414597|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
414598|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
414599|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
414600|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
414601|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
414602|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
414603|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams (mg)/kilogram (kg) on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter. Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
414604|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
414605|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
414606|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
414607|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
414608|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
414609|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
414610|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
414611|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
414612|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
414613|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
414614|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
414615|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
414616|NCT00524303|E3|Reported Event|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
414617|NCT00524303|E2|Reported Event|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
414618|NCT00524303|E1|Reported Event|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
414619|NCT00524316|B1|Baseline|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
414620|NCT00524316|P1|Participant Flow|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
414621|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
414622|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
414811|NCT00524771|B1|Baseline|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
414623|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
414624|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
414625|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
414626|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
414627|NCT00524316|E1|Reported Event|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
414628|NCT00524342|B1|Baseline|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
414629|NCT00524342|P1|Participant Flow|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
414630|NCT00524342|O1|Outcome|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
414631|NCT00524342|O1|Outcome|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
414632|NCT00524342|E1|Reported Event|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
414633|NCT00524368|B3|Baseline|Total|Total of all reporting groups
414634|NCT00524368|B2|Baseline|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414635|NCT00524368|B1|Baseline|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414636|NCT00524368|P2|Participant Flow|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414637|NCT00524368|P1|Participant Flow|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414638|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414639|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414640|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414641|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414642|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414643|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414644|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414645|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414646|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414647|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414648|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414649|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414650|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414651|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414652|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414653|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414654|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414655|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414656|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414657|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414658|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414659|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414662|NCT00524368|E2|Reported Event|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
414663|NCT00524368|E1|Reported Event|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
414664|NCT00524394|B1|Baseline|INFANTS|INFANTS 0 to 3 days of life >1500 G OR >32 WEEKS GA
414665|NCT00524394|P1|Participant Flow|Infants 0 to 3 Days of Life >1500 g or >32 Weeks GA|Infants born at >32 weeks of gestagional age or > 1500gm between 0 to 3 Days of Life
414666|NCT00524394|O1|Outcome|INFANTS 0 to 3 Days of Life (DOL) >1500 G OR >32 WEEKS GA|INFANTS 0 to 3 days of life born with >1500 gm OR >32 WEEKS gestational age
414667|NCT00524394|E1|Reported Event|Infants0-3 Days of Life >1500g or >32 Weeks GA|Infants born at 32 weeks of gestacional age or >1500 mg at 0-3 days of life .
414668|NCT00524420|B3|Baseline|Total|Total of all reporting groups
414669|NCT00524420|B2|Baseline|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
414670|NCT00524420|B1|Baseline|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
414671|NCT00524420|P2|Participant Flow|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
414672|NCT00524420|P1|Participant Flow|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
414673|NCT00524420|O2|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
414674|NCT00524420|O1|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
414675|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
414676|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
414677|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
414678|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
414679|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
414680|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
414681|NCT00524420|E2|Reported Event|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
414682|NCT00524420|E1|Reported Event|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
414683|NCT00524459|B1|Baseline|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
414684|NCT00524459|P1|Participant Flow|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
414685|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
414686|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
414687|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
414688|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
414689|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
414690|NCT00524459|E1|Reported Event|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
414691|NCT00524485|B1|Baseline|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
414692|NCT00524485|P1|Participant Flow|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
414711|NCT00524511|E1|Reported Event|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
414812|NCT00524771|P2|Participant Flow|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
414813|NCT00524771|P1|Participant Flow|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
414693|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
414694|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
414695|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
414696|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
414697|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
414698|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
414699|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
414700|NCT00524485|E1|Reported Event|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
414701|NCT00524511|B3|Baseline|Total|Total of all reporting groups
414702|NCT00524511|B2|Baseline|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
414703|NCT00524511|B1|Baseline|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
414704|NCT00524511|P2|Participant Flow|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
414705|NCT00524511|P1|Participant Flow|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
414706|NCT00524511|O2|Outcome|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
414707|NCT00524511|O1|Outcome|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
414708|NCT00524511|O2|Outcome|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
414709|NCT00524511|O1|Outcome|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
414710|NCT00524511|E2|Reported Event|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
414802|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
414712|NCT00524537|B1|Baseline|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414713|NCT00524537|P1|Participant Flow|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414714|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414715|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414716|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414717|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414718|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414719|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414720|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414721|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414722|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414723|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414724|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414725|NCT00524537|E1|Reported Event|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
414726|NCT00524576|B3|Baseline|Total|Total of all reporting groups
414727|NCT00524576|B2|Baseline|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414728|NCT00524576|B1|Baseline|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414729|NCT00524576|P2|Participant Flow|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414730|NCT00524576|P1|Participant Flow|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414731|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414732|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414733|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414734|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414735|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414736|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414737|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414738|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414739|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414740|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414741|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414742|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414743|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414744|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414745|NCT00524576|E2|Reported Event|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414746|NCT00524576|E1|Reported Event|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
414747|NCT00524589|B1|Baseline|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.
calcitriol: IV
dexamethasone: Oral
protein expression analysis: Correlative Study
laboratory biomarker analysis: Correlative Study"
414748|NCT00524589|P1|Participant Flow|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.
calcitriol: IV
dexamethasone: Oral
protein expression analysis: Correlative Study
laboratory biomarker analysis: Correlative Study"
414749|NCT00524589|O1|Outcome|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.
calcitriol: IV
dexamethasone: Oral
protein expression analysis: Correlative Study
laboratory biomarker analysis: Correlative Study"
414750|NCT00524589|E1|Reported Event|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.
calcitriol: IV
dexamethasone: Oral
protein expression analysis: Correlative Study
laboratory biomarker analysis: Correlative Study"
414751|NCT00524680|B5|Baseline|Total|Total of all reporting groups
414752|NCT00524680|B4|Baseline|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414753|NCT00524680|B3|Baseline|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414754|NCT00524680|B2|Baseline|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414755|NCT00524680|B1|Baseline|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally"
414756|NCT00524680|P4|Participant Flow|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414757|NCT00524680|P3|Participant Flow|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414758|NCT00524680|P2|Participant Flow|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414759|NCT00524680|P1|Participant Flow|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally"
414760|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414761|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414762|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414763|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally"
414764|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414765|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414766|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414767|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally"
414768|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414769|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414770|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414771|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally"
414772|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414773|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414774|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414775|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally"
414776|NCT00524680|E4|Reported Event|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414777|NCT00524680|E3|Reported Event|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414778|NCT00524680|E2|Reported Event|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol: Given orally"
414779|NCT00524680|E1|Reported Event|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol: Given orally"
414780|NCT00524745|B5|Baseline|Total|Total of all reporting groups
414781|NCT00524745|B4|Baseline|Standard (0,2,6 Month) Schedule|
414782|NCT00524745|B3|Baseline|0,12,24 Month Schedule|
414783|NCT00524745|B2|Baseline|0,6,12 Month Schedule|
414784|NCT00524745|B1|Baseline|0,3,9 Month Schedule|
414785|NCT00524745|P4|Participant Flow|Standard (0,2,6 Month) Schedule|
414786|NCT00524745|P3|Participant Flow|0,12,24 Month Schedule|
414787|NCT00524745|P2|Participant Flow|0,6,12 Month Schedule|
414788|NCT00524745|P1|Participant Flow|0,3,9 Month Schedule|
414789|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
414790|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
414791|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
414792|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
414793|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
414794|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
414795|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
414796|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
414797|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
414798|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
414799|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
414800|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
414801|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
414814|NCT00524771|O3|Outcome|COC2|A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
414815|NCT00524771|O2|Outcome|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
414816|NCT00524771|O1|Outcome|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
414817|NCT00524771|O3|Outcome|COC2|A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
414818|NCT00524771|O2|Outcome|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
414819|NCT00524771|O1|Outcome|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
414820|NCT00524771|E2|Reported Event|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
414821|NCT00524771|E1|Reported Event|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
414822|NCT00524940|B1|Baseline|Study Group|All participants enrolled and received Fluzone® Vaccine
414823|NCT00524940|P1|Participant Flow|Study Group|All participants enrolled and received Fluzone® Vaccine
414824|NCT00524940|O1|Outcome|Study Group|All participants enrolled and received Fluzone® Vaccine
414825|NCT00524940|O1|Outcome|Study Group|All participants enrolled and received Fluzone® Vaccine
414826|NCT00524940|E1|Reported Event|Study Group|All participants enrolled and received Fluzone® Vaccine
414827|NCT00516737|B3|Baseline|Total|Total of all reporting groups
414828|NCT00516737|B2|Baseline|Placebo|Matching placebo; one dose, treatment of a single migraine attack
414829|NCT00516737|B1|Baseline|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
414830|NCT00516737|P2|Participant Flow|Placebo|Matching placebo; one dose, treatment of a single migraine attack
414831|NCT00516737|P1|Participant Flow|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
414832|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
414833|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
414834|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
414835|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
414836|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
414837|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
414838|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
414839|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
414840|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
414841|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
414842|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
414843|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
414844|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
414845|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
414846|NCT00516737|E2|Reported Event|Placebo|Matching placebo; one dose, treatment of a single migraine attack
414847|NCT00516737|E1|Reported Event|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
414848|NCT00516893|B1|Baseline|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
414849|NCT00516893|P1|Participant Flow|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
414850|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
414851|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
414852|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
414853|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
414854|NCT00516893|E1|Reported Event|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
414855|NCT00516906|B3|Baseline|Total|Total of all reporting groups
414856|NCT00516906|B2|Baseline|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
414857|NCT00516906|B1|Baseline|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
414858|NCT00516906|P2|Participant Flow|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
414859|NCT00516906|P1|Participant Flow|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
414860|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
414861|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
414862|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
414863|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
414864|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
414865|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
414866|NCT00516906|E2|Reported Event|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
414867|NCT00516906|E1|Reported Event|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
414868|NCT00516919|B1|Baseline|Total Enrollment|
414869|NCT00516919|P2|Participant Flow|Placebo + Behavioral Intervention|"Drug: Placebo + Behavioral: behavioral intervention
Behavioral intervention + placebo : Behavioral weight loss treatment in Spanish Placebo three times a day"
414870|NCT00516919|P1|Participant Flow|Xenical + Behavioral Intervention|"Drug: Xenical + Behavioral: behavioral intervention
Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
414871|NCT00516919|O2|Outcome|Drug: Placebo + Behavioral: Behavioral Intervention|"Placebo + behavioral intervention
Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID"
414872|NCT00516919|O1|Outcome|Drug: Xenical + Behavioral: Behavioral Intervention|"Xenical + behavioral intervention
Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
414873|NCT00516919|E2|Reported Event|Drug: Placebo + Behaviora: Behavioral Intervention|"Placebo + behavioral intervention
Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID"
414874|NCT00516919|E1|Reported Event|Drug: Xenical + Behavioral: Behavioral Intervention|"Xenical + behavioral intervention
Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
414875|NCT00517010|B1|Baseline|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
414876|NCT00517010|P1|Participant Flow|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
414877|NCT00517010|O1|Outcome|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
414878|NCT00517010|O1|Outcome|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
414879|NCT00517010|E1|Reported Event|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
414880|NCT00517075|B5|Baseline|Total|Total of all reporting groups
414881|NCT00517075|B4|Baseline|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)
repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414882|NCT00517075|B3|Baseline|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414883|NCT00517075|B2|Baseline|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414884|NCT00517075|B1|Baseline|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414885|NCT00517075|P4|Participant Flow|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)
repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
415069|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
414886|NCT00517075|P3|Participant Flow|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414887|NCT00517075|P2|Participant Flow|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414888|NCT00517075|P1|Participant Flow|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414889|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)
repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414890|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414891|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414892|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414893|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)
repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414894|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414949|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414950|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414895|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414896|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414897|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)
repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414898|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414899|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414900|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414901|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)
repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414902|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414903|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414951|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414952|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
415067|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
414904|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414905|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)
repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414906|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414907|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414908|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414909|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)
repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414910|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414911|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414912|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414953|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414954|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
431231|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
414913|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)
repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414914|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414915|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414916|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414917|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)
repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414918|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414919|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414920|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414921|NCT00517075|E4|Reported Event|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)
repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414955|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
415068|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
414922|NCT00517075|E3|Reported Event|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414923|NCT00517075|E2|Reported Event|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414924|NCT00517075|E1|Reported Event|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
414925|NCT00517192|B3|Baseline|Total|Total of all reporting groups
414926|NCT00517192|B2|Baseline|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414927|NCT00517192|B1|Baseline|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414928|NCT00517192|P2|Participant Flow|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414929|NCT00517192|P1|Participant Flow|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414930|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414931|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414932|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414933|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414934|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414935|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414936|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414937|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414938|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414939|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414940|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414941|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414942|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414943|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414944|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414945|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414946|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414947|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414948|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414956|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414957|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414958|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414959|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414960|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414961|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414962|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414963|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414964|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414965|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414966|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414967|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414968|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414969|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414970|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414971|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414972|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414973|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414974|NCT00517192|E2|Reported Event|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
414975|NCT00517192|E1|Reported Event|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
414976|NCT00517296|B3|Baseline|Total|Total of all reporting groups
414977|NCT00517296|B2|Baseline|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
414978|NCT00517296|B1|Baseline|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
414979|NCT00517296|P2|Participant Flow|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
414980|NCT00517296|P1|Participant Flow|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
414981|NCT00517296|O2|Outcome|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
414982|NCT00517296|O1|Outcome|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
414983|NCT00517296|O2|Outcome|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
414984|NCT00517296|O1|Outcome|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
414985|NCT00517296|O2|Outcome|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
414986|NCT00517296|O1|Outcome|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
414987|NCT00517296|E2|Reported Event|B, Control Arm|Group B patients will be randomized to surgical guidance / standard of care
414988|NCT00517296|E1|Reported Event|A, Combination Therapy Group|"Group A patients will be randomized to TNF and seton placement.
Seton placement: Patients randomized to the combination therapy group will have seton placement prior to initiating therapy with Certolizumab."
414989|NCT00517361|B1|Baseline|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
414990|NCT00517361|P1|Participant Flow|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
414991|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
414992|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
414993|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
414994|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
414995|NCT00517361|E1|Reported Event|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
414996|NCT00517413|B1|Baseline|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
414997|NCT00517413|P1|Participant Flow|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta [Mircera]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
414998|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
414999|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415000|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415001|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415002|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415003|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415004|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415005|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415006|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415007|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415008|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415009|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415010|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415011|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415066|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415012|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415013|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415014|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415015|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415016|NCT00517413|E1|Reported Event|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
415017|NCT00517530|B8|Baseline|Total|Total of all reporting groups
415018|NCT00517530|B7|Baseline|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
415019|NCT00517530|B6|Baseline|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415020|NCT00517530|B5|Baseline|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415021|NCT00517530|B4|Baseline|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415022|NCT00517530|B3|Baseline|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415023|NCT00517530|B2|Baseline|400-2000 mg Phase I, CLL|Obinutuzumab intravenous infusion
415024|NCT00517530|B1|Baseline|50-2000 mg Phase I, NHL|Obinutuzumab intravenous infusion
415025|NCT00517530|P7|Participant Flow|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
415026|NCT00517530|P6|Participant Flow|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415027|NCT00517530|P5|Participant Flow|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415028|NCT00517530|P4|Participant Flow|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415029|NCT00517530|P3|Participant Flow|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415030|NCT00517530|P2|Participant Flow|400-2000 mg Phase I, CLL|Obinutuzumab intravenous infusion
415031|NCT00517530|P1|Participant Flow|50-2000 mg Phase I, NHL|Obinutuzumab intravenous infusion
415032|NCT00517530|O4|Outcome|2000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
415033|NCT00517530|O3|Outcome|1200 mg - Phase I, CLL|Obinutuzumab intravenous infusion
415034|NCT00517530|O2|Outcome|800 mg - Phase I, CLL|Obinutuzumab intravenous infusion
415035|NCT00517530|O1|Outcome|400 mg - Phase I, CLL|Obinutuzumab intravenous infusion
415036|NCT00517530|O4|Outcome|2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415037|NCT00517530|O3|Outcome|1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415038|NCT00517530|O2|Outcome|800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415039|NCT00517530|O1|Outcome|400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415040|NCT00517530|O4|Outcome|2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415041|NCT00517530|O3|Outcome|1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415042|NCT00517530|O2|Outcome|800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415043|NCT00517530|O1|Outcome|400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415044|NCT00517530|O1|Outcome|Retreated Participants|Obinutuzumab intravenous infusion
415045|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
415046|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415047|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415048|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415049|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415050|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
415051|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415052|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415053|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415054|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415055|NCT00517530|O3|Outcome|Phase II, CLL|Obinutuzumab intravenous infusion at 1000/1000 mg
415056|NCT00517530|O2|Outcome|Phase II, aNHL|Obinutuzumab intravenous infusion at 400/400 mg and 1600/800 mg
415057|NCT00517530|O1|Outcome|Phase II, iNHL|Obinutuzumab intravenous infusion at 400/400 mg and 1600/800 mg
415058|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
415059|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415060|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415061|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415062|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415063|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
415064|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415065|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415194|NCT00525174|O2|Outcome|Patching|
415071|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415072|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415073|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
415074|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415075|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
415076|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415077|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
415078|NCT00517530|O11|Outcome|1000/1000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
415079|NCT00517530|O10|Outcome|1200/2000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
415080|NCT00517530|O9|Outcome|800/1200 mg - Phase I, CLL|Obinutuzumab intravenous infusion
415081|NCT00517530|O8|Outcome|400/800 mg - Phase I, CLL|Obinutuzumab intravenous infusion
415082|NCT00517530|O7|Outcome|1600/800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415083|NCT00517530|O6|Outcome|1200/2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415084|NCT00517530|O5|Outcome|800/1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415085|NCT00517530|O4|Outcome|400/800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415086|NCT00517530|O3|Outcome|200/400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415087|NCT00517530|O2|Outcome|100/200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415088|NCT00517530|O1|Outcome|50/100 mg - Phase I, NHL|Obinutuzumab intravenous infusion
415089|NCT00517530|E1|Reported Event|Safety Population|Safety-Evaluable Participants
415090|NCT00517556|B3|Baseline|Total|Total of all reporting groups
415091|NCT00517556|B2|Baseline|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
415092|NCT00517556|B1|Baseline|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
415093|NCT00517556|P2|Participant Flow|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
415094|NCT00517556|P1|Participant Flow|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
415095|NCT00517556|O2|Outcome|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
415096|NCT00517556|O1|Outcome|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
415097|NCT00517556|E2|Reported Event|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
415098|NCT00517556|E1|Reported Event|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
415099|NCT00517595|B1|Baseline|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
415100|NCT00517595|P1|Participant Flow|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
415101|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
415102|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
415103|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
415104|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
415105|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
415106|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
415107|NCT00517595|E1|Reported Event|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
415108|NCT00517634|B1|Baseline|Overall Study Population|Overall Study Population: participants in all three treatment periods
415109|NCT00517634|P6|Participant Flow|Sequence 6: Placebo, FP, SFC|Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
415110|NCT00517634|P5|Participant Flow|Sequence 5: FP, Placebo, SFC|Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
415111|NCT00517634|P4|Participant Flow|Sequence 4: SFC, Placebo, FP|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
415112|NCT00517634|P3|Participant Flow|Sequence 3: SFC, FP, Placebo|Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
415195|NCT00525174|O1|Outcome|Bangerter|
415196|NCT00525174|O2|Outcome|Patching|
415222|NCT00525174|E2|Reported Event|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
456459|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
415113|NCT00517634|P2|Participant Flow|Sequence 2: Placebo, SFC, FP|Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
415114|NCT00517634|P1|Participant Flow|Sequence 1: FP, SFC, Placebo|Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
415115|NCT00517634|O3|Outcome|SFC 50/100 mcg BID|Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID
415116|NCT00517634|O2|Outcome|FP 100 mcg BID|Fluticasone Propionate (FP) 100 mcg BID
415117|NCT00517634|O1|Outcome|Placebo|Placebo
415118|NCT00517634|O3|Outcome|SFC 50/100 mcg BID|Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID
415119|NCT00517634|O2|Outcome|FP 100 mcg BID|Fluticasone Propionate (FP) 100 mcg BID
415120|NCT00517634|O1|Outcome|Placebo|Placebo
415121|NCT00517634|E3|Reported Event|SFC 50/100 BID|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID
415122|NCT00517634|E2|Reported Event|FP 100 mcg BID|Fluticasone Propionate 100 mcg BID
415123|NCT00517634|E1|Reported Event|Placebo|Placebo
415124|NCT00525031|B3|Baseline|Total|Total of all reporting groups
415125|NCT00525031|B2|Baseline|TMZ + PGI|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
415126|NCT00525031|B1|Baseline|TMZ Alone|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
415127|NCT00525031|P2|Participant Flow|Temozolomide (TMZ) + Pegylated Interferon-alpha 2b (PGI)|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
415128|NCT00525031|P1|Participant Flow|Temozolomide (TMZ)|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
415129|NCT00525031|O1|Outcome|Overall Study|Arm A: TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks. Arm B: TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
415130|NCT00525031|O2|Outcome|TMZ + PGI|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
415131|NCT00525031|O1|Outcome|TMZ Alone|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
415132|NCT00525031|E2|Reported Event|TMZ + PGI|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
415133|NCT00525031|E1|Reported Event|TMZ Alone|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
415134|NCT00525135|B1|Baseline|Study Intervention|Patients receive valproic acid daily for 16 weeks.
415135|NCT00525135|P1|Participant Flow|Study Intervention|Patients receive valproic acid daily for 16 weeks.
415136|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
415137|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
415138|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
415139|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
415140|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
415141|NCT00525135|E1|Reported Event|Study Intervention|Patients receive valproic acid daily for 16 weeks.
415142|NCT00525148|B5|Baseline|Total|Total of all reporting groups
415143|NCT00525148|B4|Baseline|Second-line Afatinib 50 mg|Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
415144|NCT00525148|B3|Baseline|Second-line Afatinib 40 mg|Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
415145|NCT00525148|B2|Baseline|First-line Afatinib 50 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
415146|NCT00525148|B1|Baseline|First-line Afatinib 40 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
415147|NCT00525148|P4|Participant Flow|Second-line Afatinib 50 mg|Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
415148|NCT00525148|P3|Participant Flow|Second-line Afatinib 40 mg|Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
415149|NCT00525148|P2|Participant Flow|First-line Afatinib 50 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
415150|NCT00525148|P1|Participant Flow|First-line Afatinib 40 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
415151|NCT00525148|O2|Outcome|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
415152|NCT00525148|O1|Outcome|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
415153|NCT00525148|O2|Outcome|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
415154|NCT00525148|O1|Outcome|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
415155|NCT00525148|O3|Outcome|Afatinib 50 mg|Subjects receiving 50 mg of Afatinib daily.
415156|NCT00525148|O2|Outcome|Afatinib 40 mg|Subjects receiving 40 mg of Afatinib daily.
415157|NCT00525148|O1|Outcome|Afatinib 30 mg|Subjects receiving 30 mg of Afatinib daily.
415197|NCT00525174|O1|Outcome|Bangerter|
415158|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
415159|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
415160|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
415161|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
415162|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
415163|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
415164|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
415165|NCT00525148|E2|Reported Event|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
415166|NCT00525148|E1|Reported Event|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
415167|NCT00525161|B1|Baseline|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy
sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
415168|NCT00525161|P1|Participant Flow|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy
sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
415169|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy
sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
415170|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy
sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
415171|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy
sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
415172|NCT00525161|E1|Reported Event|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy
sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
415173|NCT00525174|B3|Baseline|Total|Total of all reporting groups
415174|NCT00525174|B2|Baseline|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
415175|NCT00525174|B1|Baseline|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
415176|NCT00525174|P2|Participant Flow|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
415177|NCT00525174|P1|Participant Flow|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
415178|NCT00525174|O2|Outcome|Patching|
415179|NCT00525174|O1|Outcome|Bangerter|
415180|NCT00525174|O2|Outcome|Patching|
415181|NCT00525174|O1|Outcome|Bangerter|
415182|NCT00525174|O2|Outcome|Patching|
415183|NCT00525174|O1|Outcome|Bangerter|
415184|NCT00525174|O2|Outcome|Patching|
415185|NCT00525174|O1|Outcome|Bangerter|
415186|NCT00525174|O2|Outcome|Patching|
415187|NCT00525174|O1|Outcome|Bangerter|
415188|NCT00525174|O2|Outcome|Patching|
415189|NCT00525174|O1|Outcome|Bangerter|
415190|NCT00525174|O2|Outcome|Patching|
415191|NCT00525174|O1|Outcome|Bangerter|
415192|NCT00525174|O2|Outcome|Patching|
415193|NCT00525174|O1|Outcome|Bangerter|
415223|NCT00525174|E1|Reported Event|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
415224|NCT00525265|B3|Baseline|Total|Total of all reporting groups
415225|NCT00525265|B2|Baseline|OPC-41061 15 mg|OPC-41061 15 mg/day
415226|NCT00525265|B1|Baseline|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
415227|NCT00525265|P2|Participant Flow|OPC-41061 15 mg|OPC-41061 1.5 mg/day
415228|NCT00525265|P1|Participant Flow|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
415229|NCT00525265|O2|Outcome|OPC-41061 15 mg|OPC-41061 15 mg/day
415230|NCT00525265|O1|Outcome|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
415231|NCT00525265|E2|Reported Event|OPC-41061 15 mg|OPC-41061 15 mg/day
415232|NCT00525265|E1|Reported Event|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
415233|NCT00530023|B3|Baseline|Total|Total of all reporting groups
415234|NCT00530023|B2|Baseline|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
415235|NCT00530023|B1|Baseline|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
415236|NCT00530023|P2|Participant Flow|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
415237|NCT00530023|P1|Participant Flow|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
415238|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
415239|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
415240|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
415241|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
415242|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
415243|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
415244|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
415245|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
415246|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
415247|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
415248|NCT00530023|E2|Reported Event|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
415249|NCT00530023|E1|Reported Event|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
415250|NCT00530075|B1|Baseline|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
415251|NCT00530075|P1|Participant Flow|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
415252|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
415253|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
415254|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
415255|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
415256|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
415257|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
415258|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
415259|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
415260|NCT00530075|E1|Reported Event|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
415261|NCT00530088|B1|Baseline|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.
porfimer sodium: IV"
415262|NCT00530088|P1|Participant Flow|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.
porfimer sodium: IV"
415263|NCT00530088|O1|Outcome|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.
porfimer sodium: IV"
415264|NCT00530088|O1|Outcome|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.
porfimer sodium: IV"
415265|NCT00530088|E1|Reported Event|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.
porfimer sodium: IV"
415266|NCT00530257|B1|Baseline|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed on the measures described below.
415267|NCT00530257|P1|Participant Flow|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed on the measures described below.
415268|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
415519|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415520|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415269|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415270|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
415271|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415272|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
415273|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415274|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
415275|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415276|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
415277|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415278|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
415279|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415280|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415281|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415282|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415283|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415284|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
415285|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed.
415286|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415287|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415313|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415518|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
431232|NCT00553267|O1|Outcome|Amlodipine 10mg|
415288|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415289|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415290|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
415291|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
415292|NCT00530257|E2|Reported Event|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects.
415293|NCT00530257|E1|Reported Event|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects.
415294|NCT00530270|B3|Baseline|Total|Total of all reporting groups
415295|NCT00530270|B2|Baseline|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415296|NCT00530270|B1|Baseline|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415297|NCT00530270|P2|Participant Flow|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415298|NCT00530270|P1|Participant Flow|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415299|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415300|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415301|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415302|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415303|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415304|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415305|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415306|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415307|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415308|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415309|NCT00530270|E2|Reported Event|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415310|NCT00530270|E1|Reported Event|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
415311|NCT00530335|B1|Baseline|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415312|NCT00530335|P1|Participant Flow|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415314|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415315|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415316|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415317|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415318|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415319|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415320|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415321|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415322|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415323|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415324|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415325|NCT00530335|E1|Reported Event|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
415326|NCT00530348|B3|Baseline|Total|Total of all reporting groups
415327|NCT00530348|B2|Baseline|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
415328|NCT00530348|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
415329|NCT00530348|P2|Participant Flow|Alemtuzumab|Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
415330|NCT00530348|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
415331|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
415332|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
415333|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
415334|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
415335|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
415336|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
415337|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
415338|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
415339|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
415340|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
415341|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
415342|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
415343|NCT00530348|E2|Reported Event|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
415344|NCT00530348|E1|Reported Event|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
415345|NCT00530439|B3|Baseline|Total|Total of all reporting groups
415346|NCT00530439|B2|Baseline|Control|
415347|NCT00530439|B1|Baseline|Lifestyle Intervention|physical activity, dietetic counselling
415348|NCT00530439|P2|Participant Flow|Control|
415349|NCT00530439|P1|Participant Flow|Lifestyle Intervention|physical activity, dietetic counselling
415350|NCT00530439|O2|Outcome|Control|
415351|NCT00530439|O1|Outcome|Lifestyle Intervention|physical activity, dietetic counselling
415352|NCT00530439|E2|Reported Event|Control|
415353|NCT00530439|E1|Reported Event|Lifestyle Intervention|physical activity, dietetic counselling
415516|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415354|NCT00530504|B1|Baseline|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
415355|NCT00530504|P1|Participant Flow|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
415356|NCT00530504|O1|Outcome|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
415357|NCT00530504|E1|Reported Event|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
415358|NCT00530634|B1|Baseline|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
415359|NCT00530634|P1|Participant Flow|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
415360|NCT00530634|O1|Outcome|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
415361|NCT00530634|E1|Reported Event|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
415362|NCT00530712|B1|Baseline|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
415363|NCT00530712|P1|Participant Flow|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
415364|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415365|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415366|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415367|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415368|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415369|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415370|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415371|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415372|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415373|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415374|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
415375|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415376|NCT00530712|E1|Reported Event|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
415377|NCT00530764|B5|Baseline|Total|Total of all reporting groups
415378|NCT00530764|B4|Baseline|Placebo|Range of 1-16 sprays per day of placebo spray
415379|NCT00530764|B3|Baseline|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415380|NCT00530764|B2|Baseline|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415381|NCT00530764|B1|Baseline|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415382|NCT00530764|P4|Participant Flow|Placebo|Range of 1-16 sprays per day of placebo spray
415383|NCT00530764|P3|Participant Flow|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415384|NCT00530764|P2|Participant Flow|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415385|NCT00530764|P1|Participant Flow|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415386|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
415387|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415388|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415389|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415390|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
415391|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415392|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415393|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415394|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
415395|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415396|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415397|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415398|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
415399|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415400|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415401|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415402|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
415403|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415404|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415405|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415406|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
415407|NCT00530764|O3|Outcome|Sativex Low Dose|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415408|NCT00530764|O2|Outcome|Sativex Medium Dose|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415409|NCT00530764|O1|Outcome|Sativex High Dose|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415410|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
415411|NCT00530764|O3|Outcome|Sativex Low Dose|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415412|NCT00530764|O2|Outcome|Sativex Medium Dose|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415413|NCT00530764|O1|Outcome|Sativex High Dose|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415414|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
415415|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415416|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415417|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415418|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
415419|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415420|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415421|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415422|NCT00530764|E4|Reported Event|Placebo|Range of 1-16 sprays per day of placebo spray
415423|NCT00530764|E3|Reported Event|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
415424|NCT00530764|E2|Reported Event|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
415425|NCT00530764|E1|Reported Event|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
415426|NCT00530777|B3|Baseline|Total|Total of all reporting groups
415427|NCT00530777|B2|Baseline|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
415428|NCT00530777|B1|Baseline|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
415429|NCT00530777|P2|Participant Flow|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
415430|NCT00530777|P1|Participant Flow|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
415431|NCT00530777|O2|Outcome|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
415432|NCT00530777|O1|Outcome|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
415433|NCT00530777|O2|Outcome|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
415434|NCT00530777|O1|Outcome|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
415435|NCT00530777|E2|Reported Event|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
415436|NCT00530777|E1|Reported Event|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
415437|NCT00530790|B1|Baseline|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415438|NCT00530790|P1|Participant Flow|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415439|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415440|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415441|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415442|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415443|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415444|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415445|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415446|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415447|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415448|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415449|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415517|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
431233|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
415450|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415451|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415452|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415453|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415454|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415455|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415456|NCT00530790|E1|Reported Event|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
415457|NCT00530816|B4|Baseline|Total|Total of all reporting groups
415458|NCT00530816|B3|Baseline|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
415459|NCT00530816|B2|Baseline|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415460|NCT00530816|B1|Baseline|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415461|NCT00530816|P3|Participant Flow|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
415462|NCT00530816|P2|Participant Flow|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415463|NCT00530816|P1|Participant Flow|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415464|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
415465|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415466|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415467|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
415468|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415469|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415470|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
415471|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415472|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415473|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
415474|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415475|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415476|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
415477|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415478|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415479|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
415480|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415481|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415482|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
415483|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415484|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415485|NCT00530816|E3|Reported Event|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
415486|NCT00530816|E2|Reported Event|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415487|NCT00530816|E1|Reported Event|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
415488|NCT00530842|B3|Baseline|Total|Total of all reporting groups
415489|NCT00530842|B2|Baseline|Fluticasone + Salmeterol / Tiotropium + Salmeterol|Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
415490|NCT00530842|B1|Baseline|Tiotropium + Salmeterol / Fluticasone + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
415491|NCT00530842|P2|Participant Flow|Fluticasone + Salmeterol / Tiotropium + Salmeterol|Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
415492|NCT00530842|P1|Participant Flow|Tiotropium + Salmeterol / Fluticasone + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
415493|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415494|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415495|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415496|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415497|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415498|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415499|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415500|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415501|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415502|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415503|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415504|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415505|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415506|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415507|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415508|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415509|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415510|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415511|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415512|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415513|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415514|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415515|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
431234|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
415521|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415522|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415523|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415524|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415525|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415526|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415527|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415528|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415529|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415530|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415531|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415532|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415533|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415534|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415535|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415536|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415537|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415538|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415539|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415540|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415541|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415542|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415543|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415544|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415545|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415546|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415547|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415548|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415549|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415550|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415551|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415552|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415553|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415554|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415555|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415556|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415557|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415558|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415559|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415560|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415561|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415562|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415563|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415564|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415565|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415566|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415567|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415568|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415569|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415570|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415571|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415572|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415573|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415574|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415575|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415576|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415577|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415578|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415579|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415580|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415581|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
431235|NCT00553267|O1|Outcome|Amlodipine 10mg|
415582|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415583|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415584|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415585|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415586|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415587|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415588|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415589|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415590|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415591|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415592|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415593|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415594|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415595|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415596|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415597|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415598|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415599|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415600|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415601|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415602|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415603|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415604|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415605|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415606|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415607|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415608|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415609|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
415610|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
415611|NCT00530842|E4|Reported Event|Fluticasone + Salmeterol (Period 2)|Flu+Sal 500+50mcg b.i.d. in Period 2
415612|NCT00530842|E3|Reported Event|Fluticasone + Salmeterol (Period 1)|Flu+Sal 500+50mcg b.i.d. in Period 1
415613|NCT00530842|E2|Reported Event|Tiotropium + Salmeterol (Period 2)|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 2
415614|NCT00530842|E1|Reported Event|Tiotropium + Salmeterol (Period 1)|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1
415615|NCT00530855|B1|Baseline|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
415616|NCT00530855|P1|Participant Flow|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
415617|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
415618|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
415619|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
415620|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
415621|NCT00530855|E1|Reported Event|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
415622|NCT00530894|B5|Baseline|Total|Total of all reporting groups
415623|NCT00530894|B4|Baseline|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
415624|NCT00530894|B3|Baseline|Inoperable TAVR|Edwards SAPIEN Transcatheter Heart Valve
415625|NCT00530894|B2|Baseline|High Risk: SAVR|Surgical Valve Replacement
415626|NCT00530894|B1|Baseline|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415627|NCT00530894|P4|Participant Flow|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
415628|NCT00530894|P3|Participant Flow|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415629|NCT00530894|P2|Participant Flow|High Risk: SAVR|Surgical Aortic Valve Replacement
415630|NCT00530894|P1|Participant Flow|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415631|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
415632|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415633|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
415634|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415635|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
415636|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415637|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
415638|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415639|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
415640|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415641|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
415642|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415643|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
415644|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415645|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
415646|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415647|NCT00530894|O2|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
415648|NCT00530894|O1|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415649|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
415650|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415651|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
415652|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415653|NCT00530894|E4|Reported Event|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
415654|NCT00530894|E3|Reported Event|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415655|NCT00530894|E2|Reported Event|High Risk: SAVR|Surgical Aortic Valve Replacement
415656|NCT00530894|E1|Reported Event|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
415657|NCT00530920|B4|Baseline|Total|Total of all reporting groups
415658|NCT00530920|B3|Baseline|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415659|NCT00530920|B2|Baseline|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415660|NCT00530920|B1|Baseline|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415661|NCT00530920|P3|Participant Flow|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415662|NCT00530920|P2|Participant Flow|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given once daily
415663|NCT00530920|P1|Participant Flow|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415664|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415665|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415666|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415667|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415668|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415669|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415670|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415671|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415672|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415673|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415674|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415675|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415676|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415677|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415678|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415679|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415680|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415681|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415682|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415683|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415684|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415685|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415686|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415687|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415688|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415689|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415690|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415691|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415692|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415693|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415694|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
417029|NCT00521924|O1|Outcome|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
415695|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415696|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415697|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415698|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415699|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415700|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415701|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415702|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415703|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415704|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415705|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415706|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415707|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415708|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415709|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415710|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415711|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415712|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415713|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415714|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415715|NCT00530920|E3|Reported Event|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
415716|NCT00530920|E2|Reported Event|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
415717|NCT00530920|E1|Reported Event|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
415718|NCT00530946|B5|Baseline|Total|Total of all reporting groups
415719|NCT00530946|B4|Baseline|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415720|NCT00530946|B3|Baseline|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415721|NCT00530946|B2|Baseline|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415722|NCT00530946|B1|Baseline|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415723|NCT00530946|P4|Participant Flow|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415724|NCT00530946|P3|Participant Flow|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415725|NCT00530946|P2|Participant Flow|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415726|NCT00530946|P1|Participant Flow|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415727|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415728|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415729|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415730|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415731|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415732|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415733|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415734|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415735|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415736|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415737|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415738|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415739|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415740|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415741|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415742|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415743|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
456460|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
415744|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415745|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415746|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415747|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415748|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415749|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415750|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415751|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415752|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415753|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415754|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415755|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415756|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415757|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415758|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415759|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415760|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415761|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415762|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415763|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415764|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415765|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415766|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415767|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415768|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415769|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415770|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415771|NCT00530946|E4|Reported Event|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
415772|NCT00530946|E3|Reported Event|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
415773|NCT00530946|E2|Reported Event|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
415774|NCT00530946|E1|Reported Event|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
415775|NCT00531011|B3|Baseline|Total|Total of all reporting groups
415776|NCT00531011|B2|Baseline|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415777|NCT00531011|B1|Baseline|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415778|NCT00531011|P2|Participant Flow|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415779|NCT00531011|P1|Participant Flow|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415780|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415781|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415782|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415783|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415784|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415785|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415786|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415787|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415788|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415789|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415790|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415791|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415792|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415793|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415794|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415795|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415796|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415797|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415798|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415799|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415800|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415801|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415802|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415803|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415804|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415805|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415806|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415807|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415808|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415809|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415810|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415811|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415812|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415813|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415814|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415815|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415816|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415817|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415818|NCT00531011|E2|Reported Event|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
415819|NCT00531011|E1|Reported Event|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
415820|NCT00531050|B7|Baseline|Total|Total of all reporting groups
415821|NCT00531050|B6|Baseline|Part 1: Sequence F, Part 2: Sequence F|"Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.
Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415822|NCT00531050|B5|Baseline|Part 1: Sequence E, Part 2: Sequence E|"Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.
Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415823|NCT00531050|B4|Baseline|Part 1; Sequence D, Part 2: Sequence D|"Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.
Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415878|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415880|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415824|NCT00531050|B3|Baseline|Part 1: Sequence C, Part 2: Sequence C|"Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.
Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415825|NCT00531050|B2|Baseline|Part 1 : Sequence B, Part 2: Sequence B|"Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.
Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415826|NCT00531050|B1|Baseline|Part 1: Sequence A, Part 2: Sequence A|"Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.
Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415827|NCT00531050|P6|Participant Flow|Part 1: Sequence F, Part 2: Sequence F|"Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.
Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415828|NCT00531050|P5|Participant Flow|Part 1: Sequence E, Part 2: Sequence E|"Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.
Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415829|NCT00531050|P4|Participant Flow|Part 1; Sequence D, Part 2: Sequence D|"Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.
Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415830|NCT00531050|P3|Participant Flow|Part 1: Sequence C, Part 2: Sequence C|"Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.
Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415846|NCT00531050|O1|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
415879|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415831|NCT00531050|P2|Participant Flow|Part 1 : Sequence B, Part 2: Sequence B|"Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.
Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415832|NCT00531050|P1|Participant Flow|Part 1: Sequence A, Part 2: Sequence A|"Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.
Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
415833|NCT00531050|O6|Outcome|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
415834|NCT00531050|O5|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
415835|NCT00531050|O4|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
415836|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415837|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415838|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415839|NCT00531050|O3|Outcome|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
415840|NCT00531050|O2|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
415841|NCT00531050|O1|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
415842|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415843|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415844|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415845|NCT00531050|O2|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
416230|NCT00531817|P2|Participant Flow|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
415847|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415848|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415849|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415850|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415851|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415852|NCT00531050|E6|Reported Event|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
415853|NCT00531050|E5|Reported Event|Part 2:Salmeterol AM 50mcg/Salmeterol PM 50mcg|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
415854|NCT00531050|E4|Reported Event|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
415855|NCT00531050|E3|Reported Event|Part 1:Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415856|NCT00531050|E2|Reported Event|Part 1:Salmeterol 50mcg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415857|NCT00531050|E1|Reported Event|Part 1:Indacaterol 300mcg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
415858|NCT00531206|B1|Baseline|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415859|NCT00531206|P1|Participant Flow|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415860|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415861|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415862|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415863|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415864|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415865|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415866|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415867|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415868|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415869|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415870|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415871|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415872|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415873|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415874|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415875|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415876|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415877|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415881|NCT00531206|E1|Reported Event|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
415882|NCT00531284|B18|Baseline|Total|Total of all reporting groups
415883|NCT00531284|B17|Baseline|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415884|NCT00531284|B16|Baseline|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415885|NCT00531284|B15|Baseline|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415886|NCT00531284|B14|Baseline|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415887|NCT00531284|B13|Baseline|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415888|NCT00531284|B12|Baseline|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415889|NCT00531284|B11|Baseline|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415890|NCT00531284|B10|Baseline|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415891|NCT00531284|B9|Baseline|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415892|NCT00531284|B8|Baseline|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415893|NCT00531284|B7|Baseline|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415894|NCT00531284|B6|Baseline|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415895|NCT00531284|B5|Baseline|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415896|NCT00531284|B4|Baseline|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415897|NCT00531284|B3|Baseline|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415898|NCT00531284|B2|Baseline|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415953|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415954|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415899|NCT00531284|B1|Baseline|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415900|NCT00531284|P17|Participant Flow|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415901|NCT00531284|P16|Participant Flow|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415902|NCT00531284|P15|Participant Flow|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415903|NCT00531284|P14|Participant Flow|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415904|NCT00531284|P13|Participant Flow|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415905|NCT00531284|P12|Participant Flow|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415906|NCT00531284|P11|Participant Flow|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415907|NCT00531284|P10|Participant Flow|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415908|NCT00531284|P9|Participant Flow|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415909|NCT00531284|P8|Participant Flow|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415910|NCT00531284|P7|Participant Flow|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415911|NCT00531284|P6|Participant Flow|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415912|NCT00531284|P5|Participant Flow|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415913|NCT00531284|P4|Participant Flow|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415914|NCT00531284|P3|Participant Flow|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415915|NCT00531284|P2|Participant Flow|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416127|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
415916|NCT00531284|P1|Participant Flow|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415917|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415918|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415919|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415920|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415921|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
415922|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415923|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415924|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415925|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415926|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
415927|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415928|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415929|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415930|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415931|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
415932|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415933|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415934|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415935|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415936|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
415937|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415938|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415939|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415940|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415941|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
415942|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415943|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415944|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415945|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415946|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
415947|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415948|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415949|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
415950|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415951|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
415952|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415955|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
415956|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
415957|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415958|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415959|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415960|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415961|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415962|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415963|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415964|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415965|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415966|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415967|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415968|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415969|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415970|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415971|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415972|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416134|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
415973|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415974|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415975|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415976|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415977|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415978|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415979|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415980|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415981|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415982|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415983|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415984|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415985|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415986|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415987|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415988|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415989|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416128|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
415990|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415991|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415992|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415993|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415994|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415995|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415996|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415997|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415998|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
415999|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416000|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416001|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416002|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416003|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416004|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416005|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416006|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416129|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
416007|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416008|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416009|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416010|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416011|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416012|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416013|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416014|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416015|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416016|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416017|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416018|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416019|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416020|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416021|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416022|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416023|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416130|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
416024|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416025|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416026|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416027|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416028|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416029|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416030|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416031|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416032|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416033|NCT00531284|O1|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment.
416034|NCT00531284|O14|Outcome|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416035|NCT00531284|O13|Outcome|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416036|NCT00531284|O12|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416037|NCT00531284|O11|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416038|NCT00531284|O10|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416039|NCT00531284|O9|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416040|NCT00531284|O8|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416041|NCT00531284|O7|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416042|NCT00531284|O6|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416043|NCT00531284|O5|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416044|NCT00531284|O4|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416045|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416046|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416047|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416048|NCT00531284|E17|Reported Event|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416049|NCT00531284|E16|Reported Event|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416050|NCT00531284|E15|Reported Event|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416051|NCT00531284|E14|Reported Event|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416052|NCT00531284|E13|Reported Event|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416053|NCT00531284|E12|Reported Event|P1B MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416054|NCT00531284|E11|Reported Event|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416055|NCT00531284|E10|Reported Event|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416056|NCT00531284|E9|Reported Event|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416057|NCT00531284|E8|Reported Event|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416058|NCT00531284|E7|Reported Event|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416131|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
416665|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416059|NCT00531284|E6|Reported Event|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416060|NCT00531284|E5|Reported Event|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416061|NCT00531284|E4|Reported Event|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416062|NCT00531284|E3|Reported Event|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416063|NCT00531284|E2|Reported Event|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416064|NCT00531284|E1|Reported Event|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
416065|NCT00531427|B3|Baseline|Total|Total of all reporting groups
416066|NCT00531427|B2|Baseline|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
416067|NCT00531427|B1|Baseline|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
416068|NCT00531427|P2|Participant Flow|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
416069|NCT00531427|P1|Participant Flow|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
416070|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
416071|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
416072|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
416073|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
416074|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
416075|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
416076|NCT00531427|E3|Reported Event|Open-label Run-in Period|The open-label run-in period was designed with duration of time sufficient to select those subjects who both tolerated and responded to treatment with BTDS 10 or BTDS 20 (an enriched design). During this period, subjects were required to discontinue use of all nonstudy drugs used for the treatment of chronic pain and no supplemental analgesic medications were allowed. Subjects who did not tolerate BTDS 5 were discontinued from the study.
416077|NCT00531427|E2|Reported Event|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
416078|NCT00531427|E1|Reported Event|Double-blind BTDS|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
416079|NCT00531453|B3|Baseline|Total|Total of all reporting groups
416080|NCT00531453|B2|Baseline|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
416081|NCT00531453|B1|Baseline|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
416082|NCT00531453|P2|Participant Flow|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
416083|NCT00531453|P1|Participant Flow|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
416084|NCT00531453|O2|Outcome|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
416085|NCT00531453|O1|Outcome|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
416086|NCT00531453|O2|Outcome|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
416087|NCT00531453|O1|Outcome|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
416088|NCT00531453|E2|Reported Event|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
416089|NCT00531453|E1|Reported Event|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
416090|NCT00531479|B3|Baseline|Total|Total of all reporting groups
416091|NCT00531479|B2|Baseline|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416092|NCT00531479|B1|Baseline|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416132|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
416093|NCT00531479|P2|Participant Flow|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416094|NCT00531479|P1|Participant Flow|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416095|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416096|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416097|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416098|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416099|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416100|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416101|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416102|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416103|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416104|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416105|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416106|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416133|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
416666|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416107|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416108|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416109|NCT00531479|E2|Reported Event|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416110|NCT00531479|E1|Reported Event|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
416111|NCT00531518|B3|Baseline|Total|Total of all reporting groups
416112|NCT00531518|B2|Baseline|Experimental Intervention|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations
Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
416113|NCT00531518|B1|Baseline|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
416114|NCT00531518|P2|Participant Flow|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations
Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
416115|NCT00531518|P1|Participant Flow|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
416116|NCT00531518|O2|Outcome|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations
Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
416117|NCT00531518|O1|Outcome|Control|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
416118|NCT00531518|E2|Reported Event|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations
Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
416119|NCT00531518|E1|Reported Event|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
416120|NCT00531661|B3|Baseline|Total|Total of all reporting groups
416121|NCT00531661|B2|Baseline|Control|CONTROL group: standard of care HF management
416122|NCT00531661|B1|Baseline|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
416123|NCT00531661|P2|Participant Flow|Control|CONTROL group: standard of care HF management
416124|NCT00531661|P1|Participant Flow|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
416125|NCT00531661|O1|Outcome|Full Duration Study Cohort|Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.
416126|NCT00531661|O1|Outcome|Full Duration Study Cohort|Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.
416135|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
416136|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
416137|NCT00531661|O1|Outcome|Entire Randomized Study Cohort|
416138|NCT00531661|O1|Outcome|Entire Study Cohort|
416139|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
416140|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
416141|NCT00531661|E2|Reported Event|Control|CONTROL group: standard of care HF management
416142|NCT00531661|E1|Reported Event|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
416143|NCT00531752|B5|Baseline|Total|Total of all reporting groups
416144|NCT00531752|B4|Baseline|PF-03654746 (Flexible Dose) First, Then Placebo|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
416145|NCT00531752|B3|Baseline|Placebo First, Then PF-03654746 (Flexible Dose)|Placebo matched to PF-03654746 capsule orally once daily in the first DB intervention period and then PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
416146|NCT00531752|B2|Baseline|PF-03654746 (Low Dose) First, Then Placebo|Low dose of PF-03654746 capsule 1 mg orally once daily for 3 weeks in first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
416147|NCT00531752|B1|Baseline|Placebo First, Then PF-03654746 (Low Dose)|Placebo matched to PF-03654746 capsule orally once daily for 3 weeks in first double-blind (DB) intervention period and then low dose of PF-03654746 capsule 1 milligram (mg) orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
416148|NCT00531752|P4|Participant Flow|PF-03654746 (Flexible Dose) First, Then Placebo|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in the first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
416149|NCT00531752|P3|Participant Flow|Placebo First, Then PF-03654746 (Flexible Dose)|Placebo matched to PF-03654746 capsule orally once daily in the first DB intervention period and then PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
416150|NCT00531752|P2|Participant Flow|PF-03654746 (Low Dose) First, Then Placebo|Low dose of PF-03654746 capsule 1 mg orally once daily for 3 weeks in first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
416151|NCT00531752|P1|Participant Flow|Placebo First, Then PF-03654746 (Low Dose)|Placebo matched to PF-03654746 capsule orally once daily for 3 weeks in first double-blind (DB) intervention period and then low dose of PF-03654746 capsule 1 milligram (mg) orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
416152|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416153|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416154|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416155|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416156|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416157|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416158|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416159|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416160|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416161|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416229|NCT00531817|B1|Baseline|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416231|NCT00531817|P1|Participant Flow|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416162|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416163|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416164|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416165|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416166|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416167|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416168|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416169|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416170|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416171|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416172|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416173|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416174|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416175|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416176|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416177|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416178|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416179|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416180|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416181|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416182|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416183|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416184|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416185|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416186|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416187|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416188|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416189|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416190|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416191|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416192|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416193|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416194|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
431236|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
416195|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416196|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416197|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416198|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416199|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416200|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416201|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416202|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416203|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416204|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416205|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416206|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416207|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416208|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416209|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416210|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416211|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416212|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416213|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416214|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416215|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416216|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416217|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416218|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416219|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416220|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416221|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416222|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416223|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416224|NCT00531752|E3|Reported Event|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
416225|NCT00531752|E2|Reported Event|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
416226|NCT00531752|E1|Reported Event|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
416227|NCT00531817|B3|Baseline|Total|Total of all reporting groups
416228|NCT00531817|B2|Baseline|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416232|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416233|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416234|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416235|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416236|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416237|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416238|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416239|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416240|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416241|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416242|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416243|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416244|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416245|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416246|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416247|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416248|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416249|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416250|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416251|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416252|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416253|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
416254|NCT00531817|E3|Reported Event|Placebo + DMARDs|Initially treated with placebo + DMARDs and received ≥ 1 dose of placebo. The placebo + DMARDs group includes all data collected while patients were on placebo for those who were initially treated with placebo in the double-blind treatment period.
416255|NCT00531817|E2|Reported Event|Placebo/Tocilizumab + DMARDs|Initially treated with placebo + DMARDs then received ≥ 1 dose of tocilizumab. The placebo/tocilizumab + DMARDs group includes all data collected after patients’ first infusion of tocilizumab (whether escape therapy or extended treatment) for those who were initially treated with placebo in the double-blind treatment period. In the extended treatment period, patients received tocilizumab 8 mg/kg 1-hour IV infusion every 4 weeks (q4weeks) for up to 1 month post-commercial availability of tocilizumab in the United States.
416256|NCT00531817|E1|Reported Event|Tocilizumab + DMARDs|Initially treated with tocilizumab + DMARDs and received ≥ 1 dose of tocilizumab. The tocilizumab + DMARDs group includes all data (double-blind and extended treatment periods) for patients who were initially treated with tocilizumab in the double-blind treatment period. In the extended treatment period, patients received tocilizumab 8 mg/kg 1-hour IV infusion every 4 weeks (q4weeks) for up to 1 month post-commercial availability of tocilizumab in the United States.
416257|NCT00531843|B3|Baseline|Total|Total of all reporting groups
416258|NCT00531843|B2|Baseline|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
416259|NCT00531843|B1|Baseline|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
416260|NCT00531843|P2|Participant Flow|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary inferior vena cava (IVC) filter (prn as determined by caregiver).
416261|NCT00531843|P1|Participant Flow|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg via subcutaneous administration (SubQ) daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
416262|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
416263|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
416264|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
416668|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416265|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
416266|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
416267|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
416268|NCT00531843|E2|Reported Event|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
416269|NCT00531843|E1|Reported Event|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
416270|NCT00531882|B4|Baseline|Total|Total of all reporting groups
416271|NCT00531882|B3|Baseline|3-Ibuprofen 1000-1600 mg Twice Daily|Ibuprofen 1000-1600 mg twice daily (max 3200 mg/day)
416272|NCT00531882|B2|Baseline|2-Simvastin|"Simvastatin
Simvastatin: 40 mg once a day"
416273|NCT00531882|B1|Baseline|1-Pioglitazone|"Pioglitazone
Pioglitazone: 30 mg once a day"
416274|NCT00531882|P3|Participant Flow|3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)|Ibuprofen will be used as the positive control for this study. Ibuprofen (Motrin, Pharmacia) will be administered twice daily.
416275|NCT00531882|P2|Participant Flow|2-Simvastatin|Simvastatin (Zocor): 40 mg once a day will be administered orally in a dose of 49 mg once daily to all subjects. This dose is considered a mid-level adult dose and the maximum pediatric dose recommended for hyperlipidemia.
416276|NCT00531882|P1|Participant Flow|1-Pioglitazone|"Pioglitazone
Pioglitazone: 30 mg once a day pioglitazone (Actos, Takeda) will be administered orally in a dose of 30 mg once daily. This is the highest recommended dose for initial control of type II diabetes."
416277|NCT00531882|O3|Outcome|3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)|"Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
Ibuprofen: Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day"
416278|NCT00531882|O2|Outcome|2-Simvastatin|"Simvastatin
Simvastatin: 40 mg once a day"
416279|NCT00531882|O1|Outcome|1-Pioglitazone|"Pioglitazone
Pioglitazone: 30 mg once a day"
416280|NCT00531882|E3|Reported Event|3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)|"Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
Ibuprofen: Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day"
416281|NCT00531882|E2|Reported Event|2-Simvastin|"Simvastatin
Simvastatin: 40 mg once a day"
416282|NCT00531882|E1|Reported Event|1-Pioglitazone|"Pioglitazone
Pioglitazone: 30 mg once a day"
416283|NCT00531934|B3|Baseline|Total|Total of all reporting groups
416284|NCT00531934|B2|Baseline|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416285|NCT00531934|B1|Baseline|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416286|NCT00531934|P2|Participant Flow|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416287|NCT00531934|P1|Participant Flow|Erlotinib Plus (+) Doxycycline|Participants received erlotinib 150 milligrams per day (mg/day), tablets, orally (PO) until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416288|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416289|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416290|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416291|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416292|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416293|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416294|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416295|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416296|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416297|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416298|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416360|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416299|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416300|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416301|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416302|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416303|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416304|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416305|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416306|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416307|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416308|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416309|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416310|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416311|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416312|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416313|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416314|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416315|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416316|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416317|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416318|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416319|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416320|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416321|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416322|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416323|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416324|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416325|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416326|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416327|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416328|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416667|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416329|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416330|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416331|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416332|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416333|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416334|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416335|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416336|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416337|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416338|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416339|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416340|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416341|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416342|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416343|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416344|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416345|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416346|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416347|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416348|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416349|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416350|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416351|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416352|NCT00531934|E2|Reported Event|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
416353|NCT00531934|E1|Reported Event|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
416354|NCT00531947|B3|Baseline|Total|Total of all reporting groups
416355|NCT00531947|B2|Baseline|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416356|NCT00531947|B1|Baseline|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416357|NCT00531947|P2|Participant Flow|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416358|NCT00531947|P1|Participant Flow|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416359|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416361|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416362|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416363|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416364|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416365|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416366|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416367|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416368|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416369|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416370|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416371|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416372|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416373|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416374|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416375|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416376|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416377|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416378|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416379|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416380|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416381|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416382|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416383|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416384|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416385|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416386|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416387|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416388|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416389|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416390|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416391|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416392|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
431237|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
416393|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416394|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416395|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416396|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416397|NCT00531947|E2|Reported Event|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416398|NCT00531947|E1|Reported Event|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
416399|NCT00531960|B3|Baseline|Total|Total of all reporting groups
416400|NCT00531960|B2|Baseline|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
416401|NCT00531960|B1|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
416402|NCT00531960|P2|Participant Flow|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
416403|NCT00531960|P1|Participant Flow|Bevacizumab Plus (+) Chemotherapy|Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 milligrams per square meter [mg/m^2], IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 milligrams per milliliter multiplied by minute [mg/mL*min] on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
416404|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
416405|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
416406|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
416407|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
416408|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
416409|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
416410|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
416441|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416411|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
416412|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
416413|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
416414|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
416415|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
416416|NCT00531960|E2|Reported Event|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
416417|NCT00531960|E1|Reported Event|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
416418|NCT00532129|B1|Baseline|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416419|NCT00532129|P1|Participant Flow|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles (28 day cycles). Participants who did not achieve complete response (CR) after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 milligrams per square meter per day (mg/m^2/day) oral administration (PO) on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416420|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416421|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416422|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416423|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416442|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
431238|NCT00553267|O1|Outcome|Amlodipine 10mg|
416424|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416425|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416426|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416427|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416428|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416429|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416430|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416431|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416432|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416433|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416434|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416435|NCT00532129|E1|Reported Event|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
416436|NCT00532155|B3|Baseline|Total|Total of all reporting groups
416437|NCT00532155|B2|Baseline|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant’s refusal.
416438|NCT00532155|B1|Baseline|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416439|NCT00532155|P2|Participant Flow|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416440|NCT00532155|P1|Participant Flow|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416443|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416444|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416445|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416446|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416447|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416448|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416449|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416450|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416451|NCT00532155|E2|Reported Event|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant’s refusal.
416452|NCT00532155|E1|Reported Event|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
416453|NCT00532259|B1|Baseline|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
416454|NCT00532259|P1|Participant Flow|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
416455|NCT00532259|O1|Outcome|CT-011|CT-011: IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
416456|NCT00532259|O1|Outcome|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
416457|NCT00532259|E1|Reported Event|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
416458|NCT00532298|B7|Baseline|Total|Total of all reporting groups
416459|NCT00532298|B6|Baseline|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416460|NCT00532298|B5|Baseline|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416461|NCT00532298|B4|Baseline|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416462|NCT00532298|B3|Baseline|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416463|NCT00532298|B2|Baseline|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416464|NCT00532298|B1|Baseline|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416465|NCT00532298|P6|Participant Flow|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416466|NCT00532298|P5|Participant Flow|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416467|NCT00532298|P4|Participant Flow|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416468|NCT00532298|P3|Participant Flow|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416469|NCT00532298|P2|Participant Flow|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416470|NCT00532298|P1|Participant Flow|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416471|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416566|NCT00532493|P2|Participant Flow|Placebo Group|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416472|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416473|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416474|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416475|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416476|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416477|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416478|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416479|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416480|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416481|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416482|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416483|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416484|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416485|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416486|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416487|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416488|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416489|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416490|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416491|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416492|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416493|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416494|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416495|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416496|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416497|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416498|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416499|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416500|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416501|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416502|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416503|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416504|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416505|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416506|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416507|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416508|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416509|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416510|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416511|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416512|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416513|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416514|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416515|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416516|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416517|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416518|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416519|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416520|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416521|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416522|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416523|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416524|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416525|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416526|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416527|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416528|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416529|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416530|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416531|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416532|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416533|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416534|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416535|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416536|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416537|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416538|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416539|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416540|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416541|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416542|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416543|NCT00532298|E6|Reported Event|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
416544|NCT00532298|E5|Reported Event|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
416545|NCT00532298|E4|Reported Event|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
416546|NCT00532298|E3|Reported Event|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
416547|NCT00532298|E2|Reported Event|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
416548|NCT00532298|E1|Reported Event|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
416549|NCT00532441|B1|Baseline|Erlotinib and Docetaxel|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
416550|NCT00532441|P2|Participant Flow|Biliary|erlotinib and docetaxel
416551|NCT00532441|P1|Participant Flow|Hepatocellular|erlotinib and docetaxel
416552|NCT00532441|O2|Outcome|Biliary|erlotinib and docetaxel
416553|NCT00532441|O1|Outcome|Hepatocellular|erlotinib and docetaxel
416554|NCT00532441|O2|Outcome|Erlotinib and Docetaxel: Hepatocellular|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
416555|NCT00532441|O1|Outcome|Erlotinib and Docetaxel: Biliary|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
416556|NCT00532441|O2|Outcome|Hepatocellular|Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
416557|NCT00532441|O1|Outcome|Biliary|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
416558|NCT00532441|E1|Reported Event|Erlotinib and Docetaxel|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
416559|NCT00532480|B1|Baseline|Duloxetine|Duloxetine : 60 mg capsules
416560|NCT00532480|P1|Participant Flow|Duloxetine|Duloxetine 60 mg capsules orally daily open label
416561|NCT00532480|O1|Outcome|Duloxetine|Duloxetine : 60 mg capsules
416562|NCT00532480|E1|Reported Event|Duloxetine|Duloxetine : 60 mg capsules
416563|NCT00532493|B3|Baseline|Total|Total of all reporting groups
416564|NCT00532493|B2|Baseline|Placebo Group|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416565|NCT00532493|B1|Baseline|Prazosin Group|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
431239|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
416567|NCT00532493|P1|Participant Flow|Prazosin Group|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416568|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416569|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416570|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416571|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416572|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416573|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416574|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416575|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416576|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416577|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416578|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416579|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416580|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416581|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416582|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416658|NCT00520572|E2|Reported Event|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
416659|NCT00520572|E1|Reported Event|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
416660|NCT00520676|B3|Baseline|Total|Total of all reporting groups
416583|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416584|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416585|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416586|NCT00532493|O2|Outcome|Placebo Group|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416587|NCT00532493|O1|Outcome|Prazosin Group|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416588|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416589|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416590|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416591|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416592|NCT00532493|O2|Outcome|Placebo Group|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416593|NCT00532493|O1|Outcome|Prazosin Group|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416594|NCT00532493|E2|Reported Event|Placebo Group|"Subjects randomized to this arm will be on placebo.
placebo: sugar pill"
416595|NCT00532493|E1|Reported Event|Prazosin Group|"Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
416596|NCT00520546|B1|Baseline|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
416661|NCT00520676|B2|Baseline|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416662|NCT00520676|B1|Baseline|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
417229|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
416597|NCT00520546|P1|Participant Flow|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
416598|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
416599|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
416600|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
416601|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
416602|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
416603|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
416604|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
416605|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
416606|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
416607|NCT00520546|O3|Outcome|PositronEmissionTomography/MagneticResonanceImaging (PET/MRI)|PET images at 45 min p.i. (post injection) and 65 min p.i. were fused with transversal endorectal and QBody T2 weighed (T2w) MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
416608|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2 weighted (T2w) turbo spin echo (TSE) transversal and a coronal short-tau inversion recovery (STIR) sequence. For prostate assessment, 3mm endorectal T2 weighed (T2w) spin echo (SE) sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
416663|NCT00520676|P2|Participant Flow|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416664|NCT00520676|P1|Participant Flow|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
431240|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
416609|NCT00520546|O1|Outcome|[18F]Fluoroethylcholine Positron-Emission-Tomography (FEC-PET)|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
416610|NCT00520546|E1|Reported Event|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
416611|NCT00520572|B7|Baseline|Total|Total of all reporting groups
416612|NCT00520572|B6|Baseline|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
416613|NCT00520572|B5|Baseline|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
416614|NCT00520572|B4|Baseline|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
416615|NCT00520572|B3|Baseline|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
416616|NCT00520572|B2|Baseline|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
416617|NCT00520572|B1|Baseline|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
416618|NCT00520572|P6|Participant Flow|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
416619|NCT00520572|P5|Participant Flow|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
416620|NCT00520572|P4|Participant Flow|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
416621|NCT00520572|P3|Participant Flow|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
416622|NCT00520572|P2|Participant Flow|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
416623|NCT00520572|P1|Participant Flow|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
416624|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
416625|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
416626|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
416627|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
416628|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
416629|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
416630|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
416631|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
416632|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
416633|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
416634|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
416635|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
416636|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
416637|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
416638|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
416639|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
416640|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
416641|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
416642|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
416643|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
416644|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
416645|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
416646|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
416647|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
416648|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
416649|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
416650|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
416651|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
416652|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
416653|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
416654|NCT00520572|E6|Reported Event|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
416655|NCT00520572|E5|Reported Event|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
416656|NCT00520572|E4|Reported Event|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
416657|NCT00520572|E3|Reported Event|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
416669|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416670|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416671|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416672|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416673|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416674|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416675|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416676|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416677|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416678|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416679|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416680|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416681|NCT00520676|E2|Reported Event|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416682|NCT00520676|E1|Reported Event|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
416683|NCT00520741|B3|Baseline|Total|Total of all reporting groups
416684|NCT00520741|B2|Baseline|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416685|NCT00520741|B1|Baseline|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416686|NCT00520741|P2|Participant Flow|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416687|NCT00520741|P1|Participant Flow|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416688|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416689|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416690|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416691|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416692|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416693|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416694|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3 :1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure."
416695|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416696|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416825|NCT00521144|P3|Participant Flow|Phase I; Level 3: Obatoclax Mesylate + Topetecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
417163|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
416697|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416698|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure."
416699|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416700|NCT00520741|E2|Reported Event|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416701|NCT00520741|E1|Reported Event|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day
Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
416702|NCT00520767|B1|Baseline|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4
bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22
dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23
melphalan: Melphalan 9 mg/m2/day days 1-4
microarray analysis: ≤28 days prior to enrollment
flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.
laboratory biomarker analysis: ≤28 days prior to enrollment
quality-of-life assessment: Start of each cycle"
416703|NCT00520767|P1|Participant Flow|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4
bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22
dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23
melphalan: Melphalan 9 mg/m2/day days 1-4
microarray analysis: ≤28 days prior to enrollment
flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.
laboratory biomarker analysis: ≤28 days prior to enrollment
quality-of-life assessment: Start of each cycle"
416704|NCT00520767|O1|Outcome|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4
bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22
dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23
melphalan: Melphalan 9 mg/m2/day days 1-4
microarray analysis: ≤28 days prior to enrollment
flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.
laboratory biomarker analysis: ≤28 days prior to enrollment
quality-of-life assessment: Start of each cycle"
416705|NCT00520767|E1|Reported Event|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4
bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22
dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23
melphalan: Melphalan 9 mg/m2/day days 1-4
microarray analysis: ≤28 days prior to enrollment
flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.
laboratory biomarker analysis: ≤28 days prior to enrollment
quality-of-life assessment: Start of each cycle"
416706|NCT00520845|B1|Baseline|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib
celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.
Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle
pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.
laboratory biomarker analysis: Blood collection"
416707|NCT00520845|P1|Participant Flow|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib
celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.
Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle
pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.
laboratory biomarker analysis: Blood collection"
416708|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib
celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.
Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle
pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.
laboratory biomarker analysis: Blood collection"
416709|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib
celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.
Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle
pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.
laboratory biomarker analysis: Blood collection"
416710|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib
celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.
Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle
pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.
laboratory biomarker analysis: Blood collection"
416711|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib
celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.
Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle
pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.
laboratory biomarker analysis: Blood collection"
416826|NCT00521144|P2|Participant Flow|Phase I; Level 2: Obatoclax Mesylate + Topetecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416712|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib
celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.
Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle
pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.
laboratory biomarker analysis: Blood collection"
416713|NCT00520845|E1|Reported Event|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib
celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.
Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle
pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.
laboratory biomarker analysis: Blood collection"
416714|NCT00520936|B9|Baseline|Total|Total of all reporting groups
416715|NCT00520936|B8|Baseline|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416716|NCT00520936|B7|Baseline|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416717|NCT00520936|B6|Baseline|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416718|NCT00520936|B5|Baseline|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416719|NCT00520936|B4|Baseline|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416720|NCT00520936|B3|Baseline|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416721|NCT00520936|B2|Baseline|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416722|NCT00520936|B1|Baseline|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
416723|NCT00520936|P8|Participant Flow|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416724|NCT00520936|P7|Participant Flow|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416725|NCT00520936|P6|Participant Flow|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416726|NCT00520936|P5|Participant Flow|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416727|NCT00520936|P4|Participant Flow|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416728|NCT00520936|P3|Participant Flow|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416729|NCT00520936|P2|Participant Flow|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416730|NCT00520936|P1|Participant Flow|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
416731|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416732|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416733|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416734|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416735|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416736|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416737|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416738|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
416739|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416740|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416741|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416742|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416743|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416744|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416745|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416746|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
416747|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416748|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416749|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416750|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416751|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416752|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416753|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
416754|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
416755|NCT00520936|E1|Reported Event|Pemetrexed|Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient <12 months old)
416756|NCT00520975|B3|Baseline|Total|Total of all reporting groups
416757|NCT00520975|B2|Baseline|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416758|NCT00520975|B1|Baseline|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416759|NCT00520975|P2|Participant Flow|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416760|NCT00520975|P1|Participant Flow|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416761|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416762|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416763|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416764|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416765|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416766|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416899|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID on Days 1 through 85 administered during the Treatment Phase
416767|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416768|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416769|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416770|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416771|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416772|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416773|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416774|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416775|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416776|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416860|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416777|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416778|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416779|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416780|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416781|NCT00520975|E2|Reported Event|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Paclitaxel: Given IV
Trastuzumab: Given IV"
416782|NCT00520975|E1|Reported Event|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Placebo: Given IV
Trastuzumab: Given IV"
416783|NCT00521001|B1|Baseline|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
416784|NCT00521001|P1|Participant Flow|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
416785|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
416786|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
416787|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
416827|NCT00521144|P1|Participant Flow|Phase I; Level 1: Obatoclax Mesylate + Topetecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416828|NCT00521144|O5|Outcome|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
416788|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
416789|NCT00521001|E1|Reported Event|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
416790|NCT00521014|B1|Baseline|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
416791|NCT00521014|P1|Participant Flow|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF
416792|NCT00521014|O1|Outcome|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
416793|NCT00521014|E1|Reported Event|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
416794|NCT00521053|B1|Baseline|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
416795|NCT00521053|P1|Participant Flow|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation. In the treatment phase, participants received a single IL injection of PV-10 into each of up to 20 study lesions on day 0 (i.e., one cycle). Treatment cycles could be repeated at weeks 8, 12 and 16 for new non-target lesions or existing target or non-target lesions not exhibiting complete response (i.e., complete disappearance). Participants were observed for 52 weeks. Radiologic assessments of visceral disease status were performed every 12 weeks throughout the study and patients were transitioned into survival follow-up if at any time the investigator identified clinical or radiologic evidence of distant progression. No other melanoma therapy was permitted during the study interval.
416796|NCT00521053|O2|Outcome|Stage IV|Participants reporting Stage IV disease at baseline
416797|NCT00521053|O1|Outcome|Stage III|Participants reporting Stage III disease at baseline
416798|NCT00521053|O1|Outcome|All Lesions Treated|
416799|NCT00521053|O2|Outcome|Stage IV|Participants reporting Stage IV disease at baseline
416800|NCT00521053|O1|Outcome|Stage III|Participants reporting Stage III disease at baseline
416801|NCT00521053|O1|Outcome|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
416802|NCT00521053|O1|Outcome|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
416803|NCT00521053|E1|Reported Event|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
416804|NCT00521079|B3|Baseline|Total|Total of all reporting groups
416805|NCT00521079|B2|Baseline|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
416806|NCT00521079|B1|Baseline|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
416807|NCT00521079|P2|Participant Flow|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
416808|NCT00521079|P1|Participant Flow|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
416809|NCT00521079|O2|Outcome|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
416810|NCT00521079|O1|Outcome|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
416811|NCT00521079|O2|Outcome|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
416812|NCT00521079|O1|Outcome|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
416813|NCT00521079|O2|Outcome|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
416814|NCT00521079|O1|Outcome|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
416815|NCT00521079|E2|Reported Event|Placebo|Subjects implanted with a functional Maestro System device that does NOT delivers therapy (Therapy OFF).
416816|NCT00521079|E1|Reported Event|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
416817|NCT00521144|B6|Baseline|Total|Total of all reporting groups
416818|NCT00521144|B5|Baseline|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
416819|NCT00521144|B4|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 4|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416820|NCT00521144|B3|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 3|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416821|NCT00521144|B2|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 2|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416822|NCT00521144|B1|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 1|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416823|NCT00521144|P5|Participant Flow|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
416824|NCT00521144|P4|Participant Flow|Phase I; Level 4: Obatoclax Mesylate + Topotecan|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
417230|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
416829|NCT00521144|O4|Outcome|Phase 1; Level 4: Obatoclax Mesylate + Topotecan|Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416830|NCT00521144|O3|Outcome|Phase I; Level 3: Obatoclax Mesylate + Topetecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416831|NCT00521144|O2|Outcome|Phase I; Level 2: Obatoclax Mesylate + Topetecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416832|NCT00521144|O1|Outcome|Phase I; Level 1: Obatoclax Mesylate + Topetecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416833|NCT00521144|E5|Reported Event|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
416834|NCT00521144|E4|Reported Event|Phase I; Level 4: Obatoclax Mesylate + Topotecan|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416835|NCT00521144|E3|Reported Event|Phase I; Level 3: Obatoclax Mesylate + Topotecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416836|NCT00521144|E2|Reported Event|Phase I; Level 2: Obatoclax Mesylate + Topotecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416837|NCT00521144|E1|Reported Event|Phase I; Level 1: Obatoclax Mesylate + Topotecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
416838|NCT00521339|B1|Baseline|Apremilast 20 mg (Treatment Phase)|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
416839|NCT00521339|P3|Participant Flow|Apremilast 20mg/30mg|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
416840|NCT00521339|P2|Participant Flow|Apremilast 20mg/20mg|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
416841|NCT00521339|P1|Participant Flow|Apremilast 20mg|Participants received 20mg Apremilast capsules by mouth (PO) twice a day (BID) on Days 1 through 85 during the Treatment Phase
416842|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
416843|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
416844|NCT00521339|O1|Outcome|Apremilast 20mg BID/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
416845|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
416846|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
416847|NCT00521339|O1|Outcome|Apremilast 20mg BID/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
416848|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
416849|NCT00521339|O1|Outcome|Apremilast 20/30mg BID|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
416850|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
416851|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416852|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416853|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416854|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416855|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416856|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416857|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416858|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416859|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
417231|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
416861|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416862|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416863|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416864|NCT00521339|O2|Outcome|Apremilast 20mg/30mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
416865|NCT00521339|O1|Outcome|Apremilast 20mg/20mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
416866|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416867|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416868|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416869|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416870|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416871|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416872|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416873|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416874|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416875|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416876|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416877|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416878|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416879|NCT00521339|O1|Outcome|Apremilast 20mg PO BID|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
416880|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
416881|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
416882|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
416883|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
416884|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
416885|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
416886|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
416887|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
416888|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
416889|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
416890|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
416891|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416892|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416893|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
416894|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
416895|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID on Days 1 through 85 administered during the treatment phase
416896|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
416897|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
416898|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
417232|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
416900|NCT00521339|E3|Reported Event|Apremilast 20mg/30mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
416901|NCT00521339|E2|Reported Event|Apremilast 20mg/20mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
416902|NCT00521339|E1|Reported Event|Apremilast 20 mg (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
416903|NCT00521352|B3|Baseline|Total|Total of all reporting groups
416904|NCT00521352|B2|Baseline|Sham|"Placebo repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
416905|NCT00521352|B1|Baseline|Active|"Active repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
416906|NCT00521352|P2|Participant Flow|Sham|"Placebo repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
416907|NCT00521352|P1|Participant Flow|Active|"Active repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
416908|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
416909|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
416910|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
416911|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
416912|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
416913|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
416914|NCT00521352|E2|Reported Event|Sham|"Placebo repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
416915|NCT00521352|E1|Reported Event|Active|"Active repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
416916|NCT00521365|B1|Baseline|Quetiapine 600 mg|Quetiapine Extended release 600 mg per day either as monotherapy or combined therapy
416917|NCT00521365|P1|Participant Flow|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416918|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416919|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416920|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
417030|NCT00521924|E2|Reported Event|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
417031|NCT00521924|E1|Reported Event|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
416921|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416922|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416923|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416924|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416925|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416926|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416927|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416928|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416929|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416930|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416931|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416932|NCT00521365|E1|Reported Event|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.
This study is a single arm study. All patients received quetiapine XR 600 mg."
416933|NCT00521456|B3|Baseline|Total|Total of all reporting groups
416934|NCT00521456|B2|Baseline|Vehicle Solution|
416935|NCT00521456|B1|Baseline|Ketorolac Solution|
416936|NCT00521456|P2|Participant Flow|Vehicle Solution|
416937|NCT00521456|P1|Participant Flow|Ketorolac Solution|
416938|NCT00521456|O2|Outcome|Vehicle Solution|
416939|NCT00521456|O1|Outcome|Ketorolac Solution|
416940|NCT00521456|O2|Outcome|Vehicle Solution|
416941|NCT00521456|O1|Outcome|Ketorolac Solution|
416942|NCT00521456|O2|Outcome|Vehicle Solution|
416943|NCT00521456|O1|Outcome|Ketorolac Solution|
416944|NCT00521456|O2|Outcome|Vehicle Solution|
416945|NCT00521456|O1|Outcome|Ketorolac Solution|
416946|NCT00521456|E2|Reported Event|Vehicle Solution|
416947|NCT00521456|E1|Reported Event|Ketorolac Solution|
416948|NCT00521586|B3|Baseline|Total|Total of all reporting groups
417032|NCT00521976|B1|Baseline|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
417033|NCT00521976|P1|Participant Flow|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
417034|NCT00521976|O1|Outcome|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
431241|NCT00553267|O1|Outcome|Amlodipine 10mg|
416949|NCT00521586|B2|Baseline|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416950|NCT00521586|B1|Baseline|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416951|NCT00521586|P2|Participant Flow|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416952|NCT00521586|P1|Participant Flow|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416953|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416954|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416955|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416956|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
417035|NCT00521976|O1|Outcome|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
417036|NCT00521976|E1|Reported Event|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
417037|NCT00521989|B6|Baseline|Total|Total of all reporting groups
417038|NCT00521989|B5|Baseline|Placebo|"Placebo
Placebo: Placebo"
417039|NCT00521989|B4|Baseline|Prednisolone|"Prednisolone 2.7 mg
Prednisolone: Prednisolone"
417114|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
416957|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416958|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416959|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416960|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416961|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416962|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416963|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416964|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
417040|NCT00521989|B3|Baseline|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)
prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
417041|NCT00521989|B2|Baseline|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)
prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
417042|NCT00521989|B1|Baseline|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)
prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
417043|NCT00521989|P5|Participant Flow|Placebo|"Placebo
Placebo: Placebo"
417115|NCT00522379|O5|Outcome|Placebo|
416965|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416966|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416967|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416968|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416969|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416970|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416971|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416972|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
417044|NCT00521989|P4|Participant Flow|Prednisolone|"Prednisolone 2.7 mg
Prednisolone: Prednisolone"
417045|NCT00521989|P3|Participant Flow|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)
prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
417046|NCT00521989|P2|Participant Flow|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)
prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
417047|NCT00521989|P1|Participant Flow|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)
prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
416973|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416974|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416975|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416976|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416977|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416978|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416979|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
417048|NCT00521989|O5|Outcome|Placebo|"Placebo
Placebo: Placebo"
417049|NCT00521989|O4|Outcome|Prednisolone|"Prednisolone 2.7 mg
Prednisolone: Prednisolone"
417050|NCT00521989|O3|Outcome|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)
prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
417051|NCT00521989|O2|Outcome|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)
prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
416980|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416981|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416982|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm on Day 1(Dose 1). Placebo matched to 13vPnC vaccine (dose 2) was administered 1 month after vaccination 1, dose 1 (13vPnC+TIV).Participants were then followed-up to 4 years (for 1 month, then 6 month and then yearly follow-up) after dose 2 of vaccination 1. Participants then received 0.5 mL dose of 13vPnC vaccine intramuscular injection into the deltoid muscle of the left arm 5 years after vaccination 1. Participants were further followed-up for 1 month and then for 6 months.
416983|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416984|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416985|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416986|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416995|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
417226|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
416987|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416988|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416989|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416990|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416991|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416992|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm on Day 1(Dose 1). Placebo matched to 13vPnC vaccine (dose 2) was administered 1 month after vaccination 1, dose 1 (13vPnC+TIV).Participants were then followed-up to 4 years (for 1 month, then 6 month and then yearly follow-up) after dose 2 of vaccination 1. Participants then received 0.5 mL dose of 13vPnC vaccine intramuscular injection into the deltoid muscle of the left arm 5 years after vaccination 1. Participants were further followed-up for 1 month and then for 6 months.
416993|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416994|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
417028|NCT00521924|O2|Outcome|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
431242|NCT00553267|E3|Reported Event|Telmisartan 80mg and Amlodipine 10mg|
416996|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
416997|NCT00521586|E12|Reported Event|Placebo+TIV/13vPnC: 6 Month Follow-up (Year 5)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
416998|NCT00521586|E11|Reported Event|Placebo+TIV/13vPnC: 13vPnC (Year 5)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
416999|NCT00521586|E10|Reported Event|Placebo+TIV/13vPnC: Years 1-4|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
417000|NCT00521586|E9|Reported Event|Placebo+TIV/13vPnC: 6 Month Follow-up (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
417001|NCT00521586|E8|Reported Event|Placebo+TIV/13vPnC: Dose 2 (Year 0)|Participants who received 0.5-mL dose of 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
417002|NCT00521586|E7|Reported Event|Placebo+TIV/13vPnC: Dose 1 (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
417003|NCT00521586|E6|Reported Event|13vPnC+TIV/Placebo: 6 Month Follow-up (Year 5)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
417004|NCT00521586|E5|Reported Event|13vPnC+TIV/Placebo: 13vPnC (Year 5)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
417005|NCT00521586|E4|Reported Event|13vPnC+TIV/Placebo: Years 1-4|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
417006|NCT00521586|E3|Reported Event|13vPnC+TIV/Placebo: 6 Month Follow-up (Year 0)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
417007|NCT00521586|E2|Reported Event|13vPnC+TIV/Placebo: Dose 2 (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
417008|NCT00521586|E1|Reported Event|13vPnC+TIV/Placebo: Dose 1 (Year 0)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
417009|NCT00521599|B4|Baseline|Total|Total of all reporting groups
417010|NCT00521599|B3|Baseline|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
417011|NCT00521599|B2|Baseline|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
417012|NCT00521599|B1|Baseline|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
417013|NCT00521599|P3|Participant Flow|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
417014|NCT00521599|P2|Participant Flow|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
417015|NCT00521599|P1|Participant Flow|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
417016|NCT00521599|O3|Outcome|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
417017|NCT00521599|O2|Outcome|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
417018|NCT00521599|O1|Outcome|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
417019|NCT00521599|E4|Reported Event|Placebo|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
417020|NCT00521599|E3|Reported Event|MF DPI 1 x 200 Mcg BID|1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 weeks
417021|NCT00521599|E2|Reported Event|MF DPI 2 x 100 mcg BID|2 inhalations of MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
417022|NCT00521599|E1|Reported Event|OL 1 X 200 mcg BID|Open-label MF DPI 200 mcg BID
417023|NCT00521924|B3|Baseline|Total|Total of all reporting groups
417024|NCT00521924|B2|Baseline|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
417025|NCT00521924|B1|Baseline|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
417026|NCT00521924|P2|Participant Flow|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
417027|NCT00521924|P1|Participant Flow|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
417052|NCT00521989|O1|Outcome|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)
prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
417053|NCT00521989|E5|Reported Event|CRx-102 (2.7/360 mg)|CRx-102 dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)
417054|NCT00521989|E4|Reported Event|CRx-102 (2.7/180 mg)|CRx-102 dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)
417055|NCT00521989|E3|Reported Event|CRx-102 (2.7/90 mg)|CRx-102 dose 1 (2.7 mg prednisolone + 90 mg dipyridamole)
417056|NCT00521989|E2|Reported Event|Prednisolone|Prednisolone 2.7 mg
417057|NCT00521989|E1|Reported Event|Placebo|Placebo
417058|NCT00522041|B3|Baseline|Total|Total of all reporting groups
417059|NCT00522041|B2|Baseline|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417060|NCT00522041|B1|Baseline|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417061|NCT00522041|P2|Participant Flow|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417062|NCT00522041|P1|Participant Flow|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417063|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417064|NCT00522041|O1|Outcome|Cellegisic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417065|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417066|NCT00522041|O1|Outcome|Cellegisic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417067|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417068|NCT00522041|O1|Outcome|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417069|NCT00522041|E2|Reported Event|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417070|NCT00522041|E1|Reported Event|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
417071|NCT00522171|B3|Baseline|Total|Total of all reporting groups
417072|NCT00522171|B2|Baseline|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.
These devices were not modified from their commercially available specifications."
417073|NCT00522171|B1|Baseline|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
417074|NCT00522171|P2|Participant Flow|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.
These devices were not modified from their commercially available specifications."
417075|NCT00522171|P1|Participant Flow|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
417076|NCT00522171|O2|Outcome|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.
These devices were not modified from their commercially available specifications."
417077|NCT00522171|O1|Outcome|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
417078|NCT00522171|O2|Outcome|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.
These devices were not modified from their commercially available specifications."
417079|NCT00522171|O1|Outcome|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
417080|NCT00522171|E2|Reported Event|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.
These devices were not modified from their commercially available specifications."
417081|NCT00522171|E1|Reported Event|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
417082|NCT00522275|B1|Baseline|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
417083|NCT00522275|P1|Participant Flow|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
417084|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
417085|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
417086|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
417087|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
417088|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
417089|NCT00522275|E1|Reported Event|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
417090|NCT00522301|B1|Baseline|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
417091|NCT00522301|P1|Participant Flow|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
417092|NCT00522301|O1|Outcome|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
417093|NCT00522301|E1|Reported Event|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
417094|NCT00522379|B6|Baseline|Total|Total of all reporting groups
417095|NCT00522379|B5|Baseline|Placebo|
417096|NCT00522379|B4|Baseline|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417097|NCT00522379|B3|Baseline|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417098|NCT00522379|B2|Baseline|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417099|NCT00522379|B1|Baseline|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417100|NCT00522379|P5|Participant Flow|Placebo|
417101|NCT00522379|P4|Participant Flow|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417102|NCT00522379|P3|Participant Flow|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417103|NCT00522379|P2|Participant Flow|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417104|NCT00522379|P1|Participant Flow|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417105|NCT00522379|O5|Outcome|Placebo|
417106|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417107|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417108|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417109|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417110|NCT00522379|O5|Outcome|Placebo|
417111|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417112|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417113|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417233|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417116|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417117|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417118|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417119|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417120|NCT00522379|O5|Outcome|Placebo|
417121|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417122|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417123|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417124|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417125|NCT00522379|O5|Outcome|Placebo|
417126|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417127|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417128|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417129|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417130|NCT00522379|O5|Outcome|Placebo|
417131|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417132|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417133|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417134|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417135|NCT00522379|O5|Outcome|Placebo|
417136|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417137|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417138|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417139|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417140|NCT00522379|O5|Outcome|Placebo|
417141|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417142|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417143|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417144|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417145|NCT00522379|O5|Outcome|Placebo|
417146|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417147|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417148|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417149|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417150|NCT00522379|O5|Outcome|Placebo|
417151|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417152|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417153|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417154|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417155|NCT00522379|O5|Outcome|Placebo|
417156|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417157|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417158|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417159|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417160|NCT00522379|O5|Outcome|Placebo|
417161|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417162|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417164|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417165|NCT00522379|O5|Outcome|Placebo|
417166|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417167|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417168|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417169|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417170|NCT00522379|O5|Outcome|Placebo|
417171|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417172|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417173|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417174|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417175|NCT00522379|O5|Outcome|Placebo|
417176|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417177|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417178|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417179|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417180|NCT00522379|O5|Outcome|Placebo|
417181|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417182|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417183|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417184|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417185|NCT00522379|O5|Outcome|Placebo|
417186|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417187|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417188|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417189|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417190|NCT00522379|O5|Outcome|Placebo|
417191|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417192|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417193|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417194|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417195|NCT00522379|O5|Outcome|Placebo|
417196|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417197|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417198|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417199|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417200|NCT00522379|E5|Reported Event|Placebo|
417201|NCT00522379|E4|Reported Event|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417202|NCT00522379|E3|Reported Event|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
417203|NCT00522379|E2|Reported Event|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417204|NCT00522379|E1|Reported Event|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
417205|NCT00522392|B3|Baseline|Total|Total of all reporting groups
417206|NCT00522392|B2|Baseline|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
bortezomib: Given IV
dexamethasone: Given PO"
417227|NCT00522418|O1|Outcome|Baseline Adverse Event Profile Score < 40|Population with Baseline Adverse Event Profile Score < 40
417228|NCT00522418|O1|Outcome|Baseline Adverse Event Profile Score >= 40|Population with Baseline Adverse Event Profile Score >= 40
417234|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417235|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417207|NCT00522392|B1|Baseline|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
bortezomib: Given IV
lenalidomide: Given PO
dexamethasone: Given PO"
417208|NCT00522392|P2|Participant Flow|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
bortezomib: Given IV
dexamethasone: Given PO"
417209|NCT00522392|P1|Participant Flow|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
bortezomib: Given IV
lenalidomide: Given PO
dexamethasone: Given PO"
417210|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
bortezomib: Given IV
dexamethasone: Given PO"
417211|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
bortezomib: Given IV
lenalidomide: Given PO
dexamethasone: Given PO"
417212|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
bortezomib: Given IV
dexamethasone: Given PO"
417213|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
bortezomib: Given IV
lenalidomide: Given PO
dexamethasone: Given PO"
417214|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
bortezomib: Given IV
dexamethasone: Given PO"
417215|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
bortezomib: Given IV
lenalidomide: Given PO
dexamethasone: Given PO"
417216|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
bortezomib: Given IV
dexamethasone: Given PO"
417217|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
bortezomib: Given IV
lenalidomide: Given PO
dexamethasone: Given PO"
417218|NCT00522392|E2|Reported Event|Arm B (Vd Regimen)|Arm B (Vd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
417219|NCT00522392|E1|Reported Event|Arm A (VRd Regimen)|Arm A (VRd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
417220|NCT00522418|B3|Baseline|Total|Total of all reporting groups
417221|NCT00522418|B2|Baseline|Best Medical Practice|Best Medical Practice Without VNS Therapy
417222|NCT00522418|B1|Baseline|VNS Therapy|VNS Therapy + Best Medical Practice
417223|NCT00522418|P2|Participant Flow|Best Medical Practice|Best Medical Practice Without VNS Therapy
417224|NCT00522418|P1|Participant Flow|VNS Therapy|VNS Therapy + Best Medical Practice
417225|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417236|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417237|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417238|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417239|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417240|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417241|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417242|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417243|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417244|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417245|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417246|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417247|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417248|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417249|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417250|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417251|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417252|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417253|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417254|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417255|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417256|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417257|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417258|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417259|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417260|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417261|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417262|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417263|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417264|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417265|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
417266|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
417267|NCT00522418|E2|Reported Event|Best Medical Practice|Best Medical Practice Without VNS Therapy
417268|NCT00522418|E1|Reported Event|VNS Therapy|VNS Therapy + Best Medical Practice
417269|NCT00522431|B1|Baseline|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
417270|NCT00522431|P1|Participant Flow|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
417271|NCT00522431|O1|Outcome|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
417272|NCT00522431|O1|Outcome|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
417273|NCT00522431|E1|Reported Event|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
417274|NCT00532779|B4|Baseline|Total|Total of all reporting groups
417275|NCT00532779|B3|Baseline|Placebo|Placebo
417276|NCT00532779|B2|Baseline|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417277|NCT00532779|B1|Baseline|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417278|NCT00532779|P3|Participant Flow|Placebo|Placebo
417279|NCT00532779|P2|Participant Flow|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417280|NCT00532779|P1|Participant Flow|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417281|NCT00532779|O3|Outcome|Placebo|Placebo
417282|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417283|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417284|NCT00532779|O3|Outcome|Placebo|Placebo
417285|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417286|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417287|NCT00532779|O3|Outcome|Placebo|Placebo
417288|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417289|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417290|NCT00532779|O3|Outcome|Placebo|Placebo
417291|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417292|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417293|NCT00532779|O3|Outcome|Placebo|Placebo
417294|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417295|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417296|NCT00532779|O3|Outcome|Placebo|Placebo
417297|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417298|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417299|NCT00532779|O3|Outcome|Placebo|Placebo
417300|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417301|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417302|NCT00532779|O3|Outcome|Placebo|Placebo
417303|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417304|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417305|NCT00532779|O3|Outcome|Placebo|Placebo
417306|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417307|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417308|NCT00532779|O3|Outcome|Placebo|Placebo
417309|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417310|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417311|NCT00532779|O3|Outcome|Placebo|Placebo
417312|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417313|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417314|NCT00532779|O3|Outcome|Placebo|Placebo
417315|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417316|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417317|NCT00532779|O3|Outcome|Placebo|Placebo
417318|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417319|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417320|NCT00532779|O3|Outcome|Placebo|Placebo
417321|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417322|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417323|NCT00532779|O3|Outcome|Placebo|Placebo
417324|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417325|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417326|NCT00532779|O3|Outcome|Placebo|Placebo
417327|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417328|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417329|NCT00532779|O3|Outcome|Placebo|Placebo
417330|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417331|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417332|NCT00532779|O3|Outcome|Placebo|Placebo
417333|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417334|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417335|NCT00532779|E3|Reported Event|Placebo|Placebo
417336|NCT00532779|E2|Reported Event|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
417337|NCT00532779|E1|Reported Event|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
417338|NCT00536198|B3|Baseline|Total|Total of all reporting groups
417339|NCT00536198|B2|Baseline|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417340|NCT00536198|B1|Baseline|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417341|NCT00536198|P2|Participant Flow|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417342|NCT00536198|P1|Participant Flow|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417343|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417344|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417345|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417346|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417347|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417348|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
431243|NCT00553267|E2|Reported Event|Telmisartan 40mg and Amlodipine 10mg|
417414|NCT00536341|B1|Baseline|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
417349|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417350|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417351|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417352|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417353|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417354|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417355|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417356|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417357|NCT00536198|O2|Outcome|Placebo|Participants will take similarly looking placebo during the symptomatic period Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
417358|NCT00536198|O1|Outcome|Sertraline|Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
417359|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417360|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417361|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417362|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417363|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417364|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417365|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
431244|NCT00553267|E1|Reported Event|Amlodipine 10mg|
417366|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417367|NCT00536198|E2|Reported Event|Placebo|"Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
417368|NCT00536198|E1|Reported Event|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
417369|NCT00536263|B4|Baseline|Total|Total of all reporting groups
417370|NCT00536263|B3|Baseline|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up; treated participants.
417371|NCT00536263|B2|Baseline|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants
417372|NCT00536263|B1|Baseline|PEG 1.0 mcg/kg QW * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants
417373|NCT00536263|P3|Participant Flow|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417374|NCT00536263|P2|Participant Flow|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417375|NCT00536263|P1|Participant Flow|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417376|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417377|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417378|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417379|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417380|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417381|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417382|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417383|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417384|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417385|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417386|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417387|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417388|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417389|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417390|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417391|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417392|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417393|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417394|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417395|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417396|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417397|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417398|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417399|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417400|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417401|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417402|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417403|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417404|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417405|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417406|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
417407|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
417408|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
417409|NCT00536263|E3|Reported Event|PEG 1.5 mcg/kg QW x48 Weeks|
417410|NCT00536263|E2|Reported Event|PEG 1.5 mcg/kg QW x24 Weeks|
417411|NCT00536263|E1|Reported Event|PEG 1.0 mcg/kg QW x24 Weeks|
417412|NCT00536341|B3|Baseline|Total|Total of all reporting groups
417413|NCT00536341|B2|Baseline|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
417415|NCT00536341|P2|Participant Flow|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
417416|NCT00536341|P1|Participant Flow|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
417417|NCT00536341|O1|Outcome|All Patients|
417418|NCT00536341|O1|Outcome|All Patients|
417419|NCT00536341|O2|Outcome|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
417420|NCT00536341|O1|Outcome|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
417421|NCT00536341|O2|Outcome|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
417422|NCT00536341|O1|Outcome|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
417423|NCT00536341|E2|Reported Event|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
417424|NCT00536341|E1|Reported Event|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
417425|NCT00536380|B4|Baseline|Total|Total of all reporting groups
417426|NCT00536380|B3|Baseline|20-mg Desloratadine|20-mg Desloratadine once daily
417427|NCT00536380|B2|Baseline|10-mg Desloratadine|10-mg Desloratadine once daily
417428|NCT00536380|B1|Baseline|5-mg Desloratadine|5-mg Desloratadine once daily
417429|NCT00536380|P3|Participant Flow|20-mg Desloratadine|20-mg Desloratadine once daily
417430|NCT00536380|P2|Participant Flow|10-mg Desloratadine|10-mg Desloratadine once daily
417431|NCT00536380|P1|Participant Flow|5-mg Desloratadine|5-mg Desloratadine once daily
417432|NCT00536380|O3|Outcome|10-mg Desloratadine|10-mg Desloratadine once daily
417433|NCT00536380|O2|Outcome|20-mg Desloratadine|20-mg Desloratadine once daily
417434|NCT00536380|O1|Outcome|5-mg Desloratadine|5-mg Desloratadine once daily
417435|NCT00536380|E3|Reported Event|20-mg Desloratadine|20-mg Desloratadine once daily
417436|NCT00536380|E2|Reported Event|10-mg Desloratadine|10-mg Desloratadine once daily
417437|NCT00536380|E1|Reported Event|5-mg Desloratadine|5-mg Desloratadine once daily
417438|NCT00536471|B5|Baseline|Total|Total of all reporting groups
417439|NCT00536471|B4|Baseline|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417440|NCT00536471|B3|Baseline|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417441|NCT00536471|B2|Baseline|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417442|NCT00536471|B1|Baseline|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417443|NCT00536471|P4|Participant Flow|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417444|NCT00536471|P3|Participant Flow|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417445|NCT00536471|P2|Participant Flow|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417446|NCT00536471|P1|Participant Flow|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417447|NCT00536471|O4|Outcome|Placebo (Rescued)|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417448|NCT00536471|O3|Outcome|Placebo (Not Rescued)|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417449|NCT00536471|O2|Outcome|Duloxetine (Escalated)|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants were increased to duloxetine 120 mg QD, PO for 6 months
417450|NCT00536471|O1|Outcome|Duloxetine (Not Escalated)|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants remained on duloxetine 60 mg QD, PO for 6 months.
417451|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417452|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417785|NCT00536744|B2|Baseline|Non-energized (Inactive) Application + Standard of Care|Sham: Sham treatment (non-energized, inactive device) + Standard of care wound dressing.
417453|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417454|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417455|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417456|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417457|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417458|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417459|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417460|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417461|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417462|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417463|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417464|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417465|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417466|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417467|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417468|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417469|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417470|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417471|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417472|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417473|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417474|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417475|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417476|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417477|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417478|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417479|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417480|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417566|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431266|NCT00553319|O1|Outcome|Placebo|"Placebo
Placebo: Placebo group"
417481|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417482|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417483|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417484|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417485|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417486|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417487|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417488|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417489|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417490|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417491|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417492|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417493|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417494|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417495|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417496|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417497|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417498|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417499|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417500|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417501|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417502|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417503|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417504|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417505|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417506|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417507|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417508|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417767|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417768|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417509|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417510|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417511|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417512|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417513|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417514|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417515|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417516|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417517|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417518|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417519|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417520|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417521|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417522|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417523|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417524|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417525|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417526|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417527|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417528|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417529|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417530|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417531|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417532|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417533|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417534|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417535|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417536|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417769|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417770|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417537|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417538|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417539|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417540|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417541|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417542|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417543|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417544|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417545|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417546|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417547|NCT00536471|O1|Outcome|Group B - Percent of Total Effect|The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group.
417548|NCT00536471|O4|Outcome|Group B - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
417549|NCT00536471|O3|Outcome|Group B - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
417550|NCT00536471|O2|Outcome|Group A - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
417551|NCT00536471|O1|Outcome|Group A - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
417552|NCT00536471|O1|Outcome|Group B - Percent of Total Effect|The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group.
417553|NCT00536471|O4|Outcome|Group B - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
417554|NCT00536471|O3|Outcome|Group B - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
417555|NCT00536471|O2|Outcome|Group A - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
417556|NCT00536471|O1|Outcome|Group A - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
417557|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417558|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417559|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417560|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417561|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417562|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417563|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417564|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417565|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417771|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417567|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417568|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417569|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417570|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417571|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417572|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417573|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417574|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417575|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417576|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417577|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417578|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417579|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417580|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417581|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417582|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417583|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417584|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417585|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417586|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417587|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417588|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417589|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417590|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417591|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417592|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417593|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417594|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417772|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417773|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417595|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417596|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417597|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417598|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417599|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417600|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417601|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417602|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417603|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417604|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417605|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417606|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417607|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417608|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417609|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417610|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417611|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417612|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417613|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417614|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417615|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417616|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417617|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417618|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417619|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417620|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417621|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417622|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417774|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417775|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417623|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417624|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417625|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417626|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417627|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417628|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417629|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417630|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417631|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417632|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417633|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417634|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417635|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417636|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417637|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417638|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417639|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417640|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417641|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417642|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417643|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417644|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417645|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417646|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417647|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417648|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417649|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417650|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417776|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417777|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417651|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417652|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417653|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417654|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417655|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417656|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417657|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417658|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417659|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417660|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417661|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417662|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417663|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417664|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417665|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417666|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417667|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417668|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417669|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417670|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417671|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417672|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417673|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417674|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417675|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417676|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417677|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417678|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417778|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417779|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417679|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417680|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417681|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417682|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417683|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417684|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417685|NCT00536471|E2|Reported Event|Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
417686|NCT00536471|E1|Reported Event|Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
417687|NCT00536484|B3|Baseline|Total|Total of all reporting groups
417688|NCT00536484|B2|Baseline|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417689|NCT00536484|B1|Baseline|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417690|NCT00536484|P2|Participant Flow|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417691|NCT00536484|P1|Participant Flow|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417692|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417693|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417694|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417695|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417696|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417697|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417698|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417699|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417700|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417701|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417702|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417703|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417704|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417705|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417706|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417707|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417708|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417709|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417710|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417711|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417712|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417713|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417714|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417715|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417716|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417717|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417718|NCT00536484|E2|Reported Event|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
417719|NCT00536484|E1|Reported Event|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
417720|NCT00536510|B3|Baseline|Total|Total of all reporting groups
417721|NCT00536510|B2|Baseline|Placebo|"All patients received placebo for a 4 week run-in period before randomization.
Drug: Comparator: placebo
Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks
Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
417722|NCT00536510|B1|Baseline|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.
Drug: laropiprant/niacin (MK0524A)
Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.
Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
417723|NCT00536510|P2|Participant Flow|Placebo|"All patients received placebo for a 4 week run-in period before randomization.
Drug: Comparator: placebo
Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks
Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
417724|NCT00536510|P1|Participant Flow|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.
Drug: laropiprant/niacin (MK0524A)
Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.
Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
417725|NCT00536510|O2|Outcome|Placebo|"All patients received placebo for a 4 week run-in period before randomization.
Drug: Comparator: placebo
Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks
Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
417726|NCT00536510|O1|Outcome|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.
Drug: laropiprant/niacin (MK0524A)
Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.
Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
417727|NCT00536510|O2|Outcome|Placebo|"All patients received placebo for a 4 week run-in period before randomization.
Drug: Comparator: placebo
Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks
Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
417780|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417781|NCT00536731|E3|Reported Event|Pulmicort Turbuhaler|Pulmicort Turbuhaler
417782|NCT00536731|E2|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler
417728|NCT00536510|O1|Outcome|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.
Drug: laropiprant/niacin (MK0524A)
Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.
Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
417729|NCT00536510|E2|Reported Event|Placebo|"All patients received placebo for a 4 week run-in period before randomization.
Drug: Comparator: placebo
Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks
Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
417730|NCT00536510|E1|Reported Event|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.
Drug: laropiprant/niacin (MK0524A)
Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.
Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
417731|NCT00536575|B1|Baseline|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
417732|NCT00536575|P1|Participant Flow|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
417733|NCT00536575|O1|Outcome|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
417734|NCT00536575|E1|Reported Event|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
417735|NCT00536731|B4|Baseline|Total|Total of all reporting groups
417736|NCT00536731|B3|Baseline|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417737|NCT00536731|B2|Baseline|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417738|NCT00536731|B1|Baseline|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417739|NCT00536731|P3|Participant Flow|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417740|NCT00536731|P2|Participant Flow|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417741|NCT00536731|P1|Participant Flow|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417742|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417743|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417744|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417745|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417746|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417747|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417748|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417749|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417750|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417751|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417752|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417753|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417754|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417755|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417756|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417757|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417758|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417759|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417760|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417761|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417762|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417763|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417764|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
417765|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
417766|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
417786|NCT00536744|B1|Baseline|dermaPACE Application + Standard of Care|dermaPACE: dermaPACE + Standard of care wound dressing.
417787|NCT00536744|P2|Participant Flow|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care
Sham: Sham treatment + Standard of care wound dressing."
417788|NCT00536744|P1|Participant Flow|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care
dermaPACE: dermaPACE + Standard of care wound dressing."
417789|NCT00536744|O2|Outcome|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care
Sham: Sham treatment + Standard of care wound dressing."
417790|NCT00536744|O1|Outcome|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care
dermaPACE: dermaPACE + Standard of care wound dressing."
417791|NCT00536744|E2|Reported Event|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care
Sham: Sham treatment + Standard of care wound dressing."
417792|NCT00536744|E1|Reported Event|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care
dermaPACE: dermaPACE + Standard of care wound dressing."
417793|NCT00536809|B1|Baseline|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle
417794|NCT00536809|P1|Participant Flow|Lapatinib/Oxaliplatin/Capecitabine|Phase I: Dose escalation to a maximum tolerated dose of lapatinib 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle. Phase II: Lapatinib 1000 mg/day administered orally on Days 1-21, oxaliplatin 130 mg/m^2 administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle.
417795|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417796|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417797|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417798|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417799|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417800|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417801|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417802|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417803|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417804|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417805|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417806|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417807|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417808|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417809|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417833|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417834|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417835|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417810|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417811|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417812|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417813|NCT00536809|E1|Reported Event|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
417814|NCT00536874|B1|Baseline|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
protein expression analysis
proteomic profiling
diagnostic laboratory biomarker analysis
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery"
417815|NCT00536874|P1|Participant Flow|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
protein expression analysis
proteomic profiling
diagnostic laboratory biomarker analysis
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery"
417816|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
protein expression analysis
proteomic profiling
diagnostic laboratory biomarker analysis
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery"
417817|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
protein expression analysis
proteomic profiling
diagnostic laboratory biomarker analysis
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery"
417818|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
protein expression analysis
proteomic profiling
diagnostic laboratory biomarker analysis
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery"
417819|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
protein expression analysis
proteomic profiling
diagnostic laboratory biomarker analysis
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery"
417820|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
protein expression analysis
proteomic profiling
diagnostic laboratory biomarker analysis
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery"
417821|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
protein expression analysis
proteomic profiling
diagnostic laboratory biomarker analysis
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery"
417822|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
protein expression analysis
proteomic profiling
diagnostic laboratory biomarker analysis
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery"
417823|NCT00536874|E1|Reported Event|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
protein expression analysis
proteomic profiling
diagnostic laboratory biomarker analysis
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery"
417824|NCT00536913|B3|Baseline|Total|Total of all reporting groups
417825|NCT00536913|B2|Baseline|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417826|NCT00536913|B1|Baseline|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417827|NCT00536913|P2|Participant Flow|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417828|NCT00536913|P1|Participant Flow|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417829|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417830|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417831|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417832|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417836|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417837|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417838|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417839|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417840|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417841|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417842|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417843|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417844|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417845|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417846|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417847|NCT00536913|E2|Reported Event|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
417848|NCT00536913|E1|Reported Event|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
417849|NCT00536978|B1|Baseline|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
417850|NCT00536978|P1|Participant Flow|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
417851|NCT00536978|O1|Outcome|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
417852|NCT00536978|E1|Reported Event|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
417853|NCT00536991|B1|Baseline|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
417854|NCT00536991|P1|Participant Flow|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
417855|NCT00536991|O1|Outcome|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
417856|NCT00536991|O1|Outcome|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
417857|NCT00536991|O1|Outcome|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
417858|NCT00536991|O1|Outcome|Treatment (Calcitriol, Ketoconazole, Hydrocortisone)|"PHASE I: Patients receive calcitriol PO QD on days 1-3, 8-10, 15-17, and 22-24. Patients also receive ketoconazole PO TID on days 1-24 and therapeutic hydrocortisone PO BID on days -1 to 24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive calcitriol and therapeutic hydrocortisone as in phase I. Patients also receive ketoconazole PO TID on days 4-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Calcitriol: Given PO
Ketoconazole: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Therapeutic Hydrocortisone: Given PO"
417890|NCT00537082|B1|Baseline|FTY720 1.25 mg|Administered orally once daily for 6 months
417891|NCT00537082|P3|Participant Flow|Placebo|Administered orally once daily for 6 months
417892|NCT00537082|P2|Participant Flow|FTY720 0.5 mg|Administered orally once daily for 6 months
417859|NCT00536991|E1|Reported Event|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
417860|NCT00537017|B1|Baseline|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
417861|NCT00537017|P1|Participant Flow|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
417862|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
417863|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
417864|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
417865|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
417866|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
417867|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
417868|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
417869|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
417870|NCT00537017|E1|Reported Event|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
417871|NCT00537030|B1|Baseline|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
pharmacological study : Correlative studies
laboratory biomarker analysis : Correlative studies
asparaginase : Given IM"
417872|NCT00537030|P1|Participant Flow|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
pharmacological study : Correlative studies
laboratory biomarker analysis : Correlative studies
asparaginase : Given IM"
417873|NCT00537030|O1|Outcome|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
pharmacological study : Correlative studies
laboratory biomarker analysis : Correlative studies
asparaginase : Given IM"
417874|NCT00537030|E1|Reported Event|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
pharmacological study : Correlative studies
laboratory biomarker analysis : Correlative studies
asparaginase : Given IM"
417875|NCT00537056|B1|Baseline|F-18 FDG PET/CT and DCE MRI|"FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
FDG PET CT: nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body
DCE MRI: DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).
F-18 Fluoro-deoxi-glucose: 15 mCi iv
Gadolinium-DTPA: 0.1 mmol/kg iv
Sunitinib: 50 mg/day po"
417876|NCT00537056|P1|Participant Flow|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
417877|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan followed by Sunitinib therapy at 50 mg/day.
417878|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
417879|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
417880|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan followed by Sunitinib therapy at 50 mg/day.
417881|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
417882|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
417883|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan
417884|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
417885|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan
417886|NCT00537056|E1|Reported Event|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
417887|NCT00537082|B4|Baseline|Total|Total of all reporting groups
417888|NCT00537082|B3|Baseline|Placebo|Administered orally once daily for 6 months
417889|NCT00537082|B2|Baseline|FTY720 0.5 mg|Administered orally once daily for 6 months
417893|NCT00537082|P1|Participant Flow|FTY720 1.25 mg|Administered orally once daily for 6 months
417894|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
417895|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
417896|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
417897|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
417898|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
417899|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
417900|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
417901|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
417902|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
417903|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
417904|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
417905|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
417906|NCT00537082|E3|Reported Event|Placebo|Administered orally once daily for 6 months
417907|NCT00537082|E2|Reported Event|FTY720 0.5mg|Administered orally once daily for 6 months
417908|NCT00537082|E1|Reported Event|FTY720 1.25mg|Administered orally once daily for 6 months
417909|NCT00537095|B3|Baseline|Total|Total of all reporting groups
417910|NCT00537095|B2|Baseline|PLACEBO|PLACEBO
417911|NCT00537095|B1|Baseline|ZD6474|ZD6474, Vandetanib 300mg
417912|NCT00537095|P2|Participant Flow|PLACEBO|PLACEBO
417913|NCT00537095|P1|Participant Flow|ZD6474|ZD6474, Vandetanib 300mg
417914|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
417915|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
417916|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
417917|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
417918|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
417919|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
417920|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
417921|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
417922|NCT00537095|E2|Reported Event|PLACEBO|PLACEBO
417923|NCT00537095|E1|Reported Event|ZD6474|ZD6474, Vandetanib 300mg
417924|NCT00537199|B1|Baseline|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
417925|NCT00537199|P1|Participant Flow|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
417926|NCT00537199|O1|Outcome|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
417927|NCT00537199|E1|Reported Event|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
417928|NCT00537238|B3|Baseline|Total|Total of all reporting groups
417929|NCT00537238|B2|Baseline|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
417930|NCT00537238|B1|Baseline|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
417931|NCT00537238|P2|Participant Flow|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
417932|NCT00537238|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily (BID) for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the titration phase (TP). If seizure control was inadequate (adequate: at least [>=] 50% reduction in seizures), pregabalin dose was escalated to 225 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week maintenance phase(MP). Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during TP and MP. After MP, participants were allowed to progress into optional (opt) blinded continuation phase, and remained on dose from MP for a maximum of 2 years or until last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
418320|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
417933|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
417934|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
417935|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
417936|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
417937|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
417938|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
417939|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
417940|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
418403|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
417941|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
417942|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
417943|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
417944|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
417945|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
417946|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
417947|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
417948|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
418404|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
417949|NCT00537238|E2|Reported Event|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
417950|NCT00537238|E1|Reported Event|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
417951|NCT00537277|B1|Baseline|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
417952|NCT00537277|P1|Participant Flow|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
417953|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
417954|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
417955|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
417956|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
417957|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
418013|NCT00537316|E3|Reported Event|IFX Through Week 8|Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
417958|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
417959|NCT00537277|E1|Reported Event|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
417960|NCT00537303|B3|Baseline|Total|Total of all reporting groups
417961|NCT00537303|B2|Baseline|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417962|NCT00537303|B1|Baseline|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417963|NCT00537303|P2|Participant Flow|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417964|NCT00537303|P1|Participant Flow|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417965|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417966|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417967|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417968|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417969|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417970|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417971|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417972|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417973|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
418235|NCT00537810|O3|Outcome|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
417974|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417975|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417976|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417977|NCT00537303|E2|Reported Event|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417978|NCT00537303|E1|Reported Event|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
417979|NCT00537316|B7|Baseline|Total|Total of all reporting groups
417980|NCT00537316|B6|Baseline|Intermittent IFX (During Part 2)|Participants enrolled directly and randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA daily in Part 2 of the study (1 participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
417981|NCT00537316|B5|Baseline|Intermittent IFX/AZA (During Part 2)|Participants enrolled directly and randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
417982|NCT00537316|B4|Baseline|Maintenance IFX/AZA (During Part 2)|Participants enrolled directly and randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
417983|NCT00537316|B3|Baseline|IFX/AZA|"All treated participants. IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.
Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14."
417984|NCT00537316|B2|Baseline|Azathioprine (AZA)|All treated participants. AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
417985|NCT00537316|B1|Baseline|Infliximab (IFX)|All treated participants. IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
417986|NCT00537316|P7|Participant Flow|Intermittent IFX (During Part 2)|Participants randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA as allocated in Part 1 of the study (1 participant from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
417987|NCT00537316|P6|Participant Flow|Intermittent IFX/AZA (During Part 2)|Participants randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
417988|NCT00537316|P5|Participant Flow|Maintenance IFX (During Part 2)|Participants randomized to maintenance IFX received infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) and placebo to AZA therapy as allocated in Part 1 of the study (all participants were from Part 1 of the study).
417989|NCT00537316|P4|Participant Flow|Maintenance IFX/AZA (During Part 2)|Participants randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
417990|NCT00537316|P3|Participant Flow|IFX/AZA|"IFX 5 mg/kg IV infusion at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.
Responders to IFX/AZA at Week 8 will receive one more IFX infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14."
417991|NCT00537316|P2|Participant Flow|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one placebo IFX infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive IFX at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
418236|NCT00537810|O2|Outcome|Placebo|"Placebo Daily
Placebo: Daily"
434167|NCT00567008|O2|Outcome|Placebo|Placebo
417992|NCT00537316|P1|Participant Flow|Infliximab (IFX)|IFX 5 mg/kg Intravenous (IV) infusions administered at Weeks 0, 2, and 6 and placebo to AZA (orally) daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
417993|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.
Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
417994|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
417995|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
417996|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.
Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
417997|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
417998|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
417999|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.
Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
418000|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
418001|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
418002|NCT00537316|E14|Reported Event|IFX (Part 2)|Participants received IV infusions of IFX 5 mg/kg of body weight until the end of the study. All participants were from Part 1 of the study.
418003|NCT00537316|E13|Reported Event|IFX/AZA (Part 2)|Participants received IV infusions of IFX 5 mg/kg of body weight every 8 weeks and AZA 2.5 mg/kg of body weight orally daily until the end of the study. All participants were from Part 1 of the study.
418004|NCT00537316|E12|Reported Event|AZA (Part 2)|Participants received AZA 2.5 mg/kg of body weight orally daily for Part 2 of the study. All participants were from Part 1 of the study.
418005|NCT00537316|E11|Reported Event|Intermittent IFX (Part 2)|Participants randomized to intermittent IFX received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained). One participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
418006|NCT00537316|E10|Reported Event|Intermittent IFX/AZA (Part 2)|Participants randomized to intermittent IFX/AZA received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily. Three participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
418007|NCT00537316|E9|Reported Event|Maintenance IFX (Part 2)|Participants randomized to maintenance IFX received IV infusions of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry). All participants were from Part 1 of the study.
418008|NCT00537316|E8|Reported Event|Maintenance IFX/AZA (Part 2)|Participants randomized to maintenance IFX/AZA during Part 2 received IV infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily. Four participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
418009|NCT00537316|E7|Reported Event|IFX After Week 8|Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
418010|NCT00537316|E6|Reported Event|IFX/AZA After Week 8|"Participants received IV infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.
Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
418011|NCT00537316|E5|Reported Event|AZA to IFX/AZA After Week 8|Participants received AZA 2.5 mg/kg orally for 16 weeks and had IV infusions of IFX 5mg/kg of body weight added to their treatment regimen at Weeks 8, 10, and 14. Participants were either non-responders to AZA at Week 8 or had worsening of disease at Week 8.
418012|NCT00537316|E4|Reported Event|AZA After Week 8|Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.
418014|NCT00537316|E2|Reported Event|IFX/AZA Through Week 8|"Participants received intravenous (IV) infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.
Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
418015|NCT00537316|E1|Reported Event|AZA Through Week 8|Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.
418016|NCT00537329|B1|Baseline|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418017|NCT00537329|P1|Participant Flow|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418018|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418019|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418020|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418021|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418022|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418023|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418024|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418025|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418026|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418027|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418028|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418029|NCT00537329|E1|Reported Event|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
418030|NCT00537381|B3|Baseline|Total|Total of all reporting groups
418031|NCT00537381|B2|Baseline|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
418032|NCT00537381|B1|Baseline|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
418033|NCT00537381|P2|Participant Flow|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
418034|NCT00537381|P1|Participant Flow|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
418035|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
418036|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
418037|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
418071|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418038|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
418039|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
418040|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
418041|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
418042|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
418043|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
418044|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
418045|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
418046|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
418047|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
418048|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
418049|NCT00537381|E4|Reported Event|Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab|Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to Docetaxel (D) + Prednisone (P) + intetumumab (9 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily till disease progression.
418050|NCT00537381|E3|Reported Event|Docetaxel + Prednisone + Placebo/ Intetumumab|Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to intetumumab alone (2 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks till disease progression.
418051|NCT00537381|E2|Reported Event|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
418052|NCT00537381|E1|Reported Event|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
418053|NCT00537394|B4|Baseline|Total|Total of all reporting groups
418054|NCT00537394|B3|Baseline|Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2|Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible.
418169|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Participants received daily oral pomalidomide 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
434168|NCT00567008|O1|Outcome|Varenicline|Varenicline (Chantix)
418055|NCT00537394|B2|Baseline|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418056|NCT00537394|B1|Baseline|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418057|NCT00537394|P3|Participant Flow|Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2|[Non-randomized Group C] : Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible.
418058|NCT00537394|P2|Participant Flow|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|[Arm B] Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418059|NCT00537394|P1|Participant Flow|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|[Arm A]Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418060|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418061|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418062|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418063|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418064|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418065|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418066|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418067|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418068|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418069|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418070|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
434169|NCT00567008|E2|Reported Event|Placebo|Placebo
418072|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418073|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418074|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418075|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418076|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418077|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418078|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418079|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418080|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418081|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418082|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418083|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418084|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418085|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418086|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418087|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418237|NCT00537810|O1|Outcome|Sibutramine|"Sibutramine 15 mg daily
Sibutramine: 15 mg daily"
434170|NCT00567008|E1|Reported Event|Varenicline|Varenicline (Chantix)
418088|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418089|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418090|NCT00537394|E2|Reported Event|Omit NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
418091|NCT00537394|E1|Reported Event|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
418092|NCT00537407|B6|Baseline|Total|Total of all reporting groups
418093|NCT00537407|B5|Baseline|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418094|NCT00537407|B4|Baseline|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418095|NCT00537407|B3|Baseline|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418096|NCT00537407|B2|Baseline|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418097|NCT00537407|B1|Baseline|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418098|NCT00537407|P5|Participant Flow|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418099|NCT00537407|P4|Participant Flow|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418100|NCT00537407|P3|Participant Flow|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418101|NCT00537407|P2|Participant Flow|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418102|NCT00537407|P1|Participant Flow|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418103|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418672|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418104|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418105|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418106|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418107|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418108|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418109|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418110|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418111|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418112|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418113|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418114|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418115|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418116|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418117|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418118|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418319|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418119|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418120|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418121|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418122|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418123|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418124|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418125|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418126|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418127|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418128|NCT00537407|O2|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418129|NCT00537407|O1|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418130|NCT00537407|O3|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418131|NCT00537407|O2|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418132|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418133|NCT00537407|E5|Reported Event|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418399|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418134|NCT00537407|E4|Reported Event|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418135|NCT00537407|E3|Reported Event|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418136|NCT00537407|E2|Reported Event|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418137|NCT00537407|E1|Reported Event|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response
Debio 025: Debio 025 supplied as a 100 mg/mL oral solution
Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
Ribavirin: Ribavirin supplied as 200 mg tablets"
418138|NCT00537485|B3|Baseline|Total|Total of all reporting groups
418139|NCT00537485|B2|Baseline|Placebo|transdermal application of placebo, 1 time per day
418140|NCT00537485|B1|Baseline|SPM962|transdermal application of SPM962, 1 time per day
418141|NCT00537485|P2|Participant Flow|Placebo|transdermal application of placebo, 1 time per day
418142|NCT00537485|P1|Participant Flow|SPM962|transdermal application of SPM962, 1 time per day
418143|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
418144|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
418145|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
418146|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
418147|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
418148|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
418149|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
418150|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
418151|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
418152|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
418153|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
418154|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
418155|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
418156|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
418157|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
418158|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
418159|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
418160|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
418161|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
418162|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
418163|NCT00537485|E2|Reported Event|Placebo|transdermal application of placebo, 1 time per day
418164|NCT00537485|E1|Reported Event|SPM962|transdermal application of SPM962, 1 time per day
418165|NCT00537511|B1|Baseline|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
418166|NCT00537511|P1|Participant Flow|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
418167|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
418168|NCT00537511|O5|Outcome|Pomalidomide (Overall, MTD Phase)|Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418400|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418170|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Participants received daily oral pomalidomide 4 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418171|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Participants received daily oral pomalidomide 3 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418172|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Participants received daily oral pomalidomide 1 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418173|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
418174|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
418175|NCT00537511|O5|Outcome|Pomalidomide (Overall, MTD Phase)|Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418176|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418177|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418178|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418179|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418180|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418181|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418182|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418183|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418184|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
418185|NCT00537511|E5|Reported Event|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
418186|NCT00537511|E4|Reported Event|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418187|NCT00537511|E3|Reported Event|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418188|NCT00537511|E2|Reported Event|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418189|NCT00537511|E1|Reported Event|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
418190|NCT00537680|B4|Baseline|Total|Total of all reporting groups
418191|NCT00537680|B3|Baseline|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
418192|NCT00537680|B2|Baseline|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
418193|NCT00537680|B1|Baseline|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
418194|NCT00537680|P3|Participant Flow|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
418195|NCT00537680|P2|Participant Flow|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
418196|NCT00537680|P1|Participant Flow|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
418197|NCT00537680|O3|Outcome|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
418198|NCT00537680|O2|Outcome|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
418199|NCT00537680|O1|Outcome|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
418200|NCT00537680|E3|Reported Event|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
418201|NCT00537680|E2|Reported Event|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
418202|NCT00537680|E1|Reported Event|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
418203|NCT00537745|B1|Baseline|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
418204|NCT00537745|P1|Participant Flow|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
418205|NCT00537745|O1|Outcome|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
418206|NCT00537745|O1|Outcome|Participants|Intervention Group
418207|NCT00537745|E1|Reported Event|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
418208|NCT00537771|B3|Baseline|Total|Total of all reporting groups
418209|NCT00537771|B2|Baseline|TAM Group|Tamoxifen : 20 mg once daily oral dose
418210|NCT00537771|B1|Baseline|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
418211|NCT00537771|P2|Participant Flow|TAM Group|Tamoxifen : 20 mg once daily oral dose
418212|NCT00537771|P1|Participant Flow|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
418213|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
418214|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
418215|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
418216|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
418217|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
418218|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
418219|NCT00537771|E2|Reported Event|TAM Group|Tamoxifen : 20 mg once daily oral dose
418220|NCT00537771|E1|Reported Event|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
418221|NCT00537810|B5|Baseline|Total|Total of all reporting groups
418222|NCT00537810|B4|Baseline|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
418223|NCT00537810|B3|Baseline|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
418224|NCT00537810|B2|Baseline|Placebo|"Placebo Daily
Placebo: Daily"
418225|NCT00537810|B1|Baseline|Sibutramine|"Sibutramine 15 mg daily
Sibutramine: 15 mg daily"
418226|NCT00537810|P4|Participant Flow|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
418227|NCT00537810|P3|Participant Flow|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
418228|NCT00537810|P2|Participant Flow|Placebo|"Placebo Daily
Placebo: Daily"
418229|NCT00537810|P1|Participant Flow|Sibutramine|"Sibutramine 15 mg daily
Sibutramine: 15 mg daily"
418230|NCT00537810|O4|Outcome|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
418231|NCT00537810|O3|Outcome|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
418232|NCT00537810|O2|Outcome|Placebo|"Placebo Daily
Placebo: Daily"
418233|NCT00537810|O1|Outcome|Sibutramine|"Sibutramine 15 mg daily
Sibutramine: 15 mg daily"
418234|NCT00537810|O4|Outcome|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
418238|NCT00537810|E4|Reported Event|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
418239|NCT00537810|E3|Reported Event|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
418240|NCT00537810|E2|Reported Event|Placebo|"Placebo Daily
Placebo: Daily"
418241|NCT00537810|E1|Reported Event|Sibutramine|"Sibutramine 15 mg daily
Sibutramine: 15 mg daily"
418242|NCT00537823|B3|Baseline|Total|Total of all reporting groups
418243|NCT00537823|B2|Baseline|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2
Week 7
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2
Week 7, 15
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2"
418244|NCT00537823|B1|Baseline|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m2 IV weekly"
418245|NCT00537823|P2|Participant Flow|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2
Week 7
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2
Week 7, 15
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2"
418246|NCT00537823|P1|Participant Flow|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m2 IV
Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV
5FU bolus 400 mg/m2
5FU CIVI 1200 mg/m2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m2 IV weekly"
418247|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2"
418248|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m^2 IV weekly"
418249|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2"
418250|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m^2 IV weekly"
418251|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2"
418312|NCT00538213|B1|Baseline|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418313|NCT00538213|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418252|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m^2 IV weekly"
418253|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2"
418254|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m^2 IV weekly"
418255|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2"
418256|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m^2 IV weekly"
418257|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2"
418258|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m^2 IV weekly"
418259|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2"
418260|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m^2 IV weekly"
418261|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2"
418314|NCT00538213|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418315|NCT00538213|P1|Participant Flow|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418673|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418262|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m^2 IV weekly"
418263|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2"
418264|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m^2 IV weekly"
418265|NCT00537823|E2|Reported Event|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy
Weeks 1, 3, 5
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
Bevacizumab 5 mg/kg IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2
Week 7, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2"
418266|NCT00537823|E1|Reported Event|Arm 1 - Wildtype|"Neoadjuvant therapy
Week 1
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly
Weeks 3, 5, 7
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
Leucovorin 400 mg/m^2 IV
Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV
5FU bolus 400 mg/m^2
5FU CIVI 1200 mg/m^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
*Cetuximab 250 mg/m^2 IV weekly"
418267|NCT00537940|B3|Baseline|Total|Total of all reporting groups
418268|NCT00537940|B2|Baseline|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418269|NCT00537940|B1|Baseline|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418270|NCT00537940|P2|Participant Flow|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418271|NCT00537940|P1|Participant Flow|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418316|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418401|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418272|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418273|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418274|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418275|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418276|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418277|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418278|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418279|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418317|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418402|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418280|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418281|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418282|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418283|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418284|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418285|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418286|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418287|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418318|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
434405|NCT00567307|B3|Baseline|Total|Total of all reporting groups
418288|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418289|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418290|NCT00537940|E2|Reported Event|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
418291|NCT00537940|E1|Reported Event|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
418292|NCT00537979|B3|Baseline|Total|Total of all reporting groups
418293|NCT00537979|B2|Baseline|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
418294|NCT00537979|B1|Baseline|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
418295|NCT00537979|P2|Participant Flow|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
418296|NCT00537979|P1|Participant Flow|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
418297|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
418298|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
418299|NCT00537979|O1|Outcome|Per-Protocol Population|The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. For this outcome measure, the group evaluated included both participants on hemodialysis receiving paricalcitol injection and those on peritoneal dialysis receiving paricalcitol capsules.
418300|NCT00537979|O1|Outcome|Per-Protocol Population|The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. For this outcome measure, the group evaluated included both participants on hemodialysis receiving paricalcitol injection and those on peritoneal dialysis receiving paricalcitol capsules.
418301|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
418302|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
418303|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
418304|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
418305|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
418306|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
418307|NCT00537979|E2|Reported Event|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
418308|NCT00537979|E1|Reported Event|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
418309|NCT00538213|B4|Baseline|Total|Total of all reporting groups
418310|NCT00538213|B3|Baseline|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418311|NCT00538213|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418321|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418322|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418323|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418324|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418325|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418326|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418327|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418328|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418329|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418330|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418331|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418332|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418333|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418334|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418335|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418336|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418337|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418338|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418339|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418340|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418341|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418342|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418343|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418344|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418345|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418346|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418347|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418348|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418349|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
437281|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
418350|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418351|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418352|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418353|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418354|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418355|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418356|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418357|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
418358|NCT00538213|E3|Reported Event|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418359|NCT00538213|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
418360|NCT00538213|E1|Reported Event|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
418361|NCT00538291|B1|Baseline|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
418362|NCT00538291|P1|Participant Flow|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
418363|NCT00538291|O1|Outcome|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
418364|NCT00538291|E1|Reported Event|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
418365|NCT00538304|B3|Baseline|Total|Total of all reporting groups
418366|NCT00538304|B2|Baseline|Placebo|Placebo
418367|NCT00538304|B1|Baseline|Bimatoprost Eye Drops|Bimatoprost eye drops
418368|NCT00538304|P2|Participant Flow|Placebo|Placebo
418369|NCT00538304|P1|Participant Flow|Bimatoprost Eye Drops|Bimatoprost eye drops
418370|NCT00538304|O2|Outcome|Placebo|Placebo
418371|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
418372|NCT00538304|O2|Outcome|Placebo|Placebo
418373|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
418374|NCT00538304|O2|Outcome|Placebo|Placebo
418375|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
418376|NCT00538304|O2|Outcome|Placebo|Placebo
418377|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
418378|NCT00538304|O2|Outcome|Placebo|Placebo
418379|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
418380|NCT00538304|O2|Outcome|Placebo|Placebo
418381|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
418382|NCT00538304|E2|Reported Event|Placebo|Placebo
418383|NCT00538304|E1|Reported Event|Bimatoprost Eye Drops|Bimatoprost eye drops
418384|NCT00538434|B5|Baseline|Total|Total of all reporting groups
418385|NCT00538434|B4|Baseline|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418386|NCT00538434|B3|Baseline|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418387|NCT00538434|B2|Baseline|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418388|NCT00538434|B1|Baseline|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418389|NCT00538434|P4|Participant Flow|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418390|NCT00538434|P3|Participant Flow|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418391|NCT00538434|P2|Participant Flow|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418392|NCT00538434|P1|Participant Flow|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418393|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418394|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418395|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418396|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418397|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418398|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418674|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418405|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
456461|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
418406|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418407|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418408|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418409|NCT00538434|E4|Reported Event|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418410|NCT00538434|E3|Reported Event|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418411|NCT00538434|E2|Reported Event|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418412|NCT00538434|E1|Reported Event|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
418413|NCT00538473|B3|Baseline|Total|Total of all reporting groups
418414|NCT00538473|B2|Baseline|Fluarix Group|Subjects received 1 dose of Fluarix™.
418415|NCT00538473|B1|Baseline|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418416|NCT00538473|P2|Participant Flow|Fluarix Group|Subjects received 1 dose of Fluarix™.
418417|NCT00538473|P1|Participant Flow|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418418|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418419|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418420|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418421|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418422|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418423|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418424|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418425|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418426|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418427|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418428|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418429|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418430|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418431|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418432|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418433|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418434|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418435|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418436|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418437|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418438|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418439|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418440|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418441|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418442|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418443|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418444|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
418445|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418446|NCT00538473|E2|Reported Event|Fluarix Group|Subjects received 1 dose of Fluarix™.
418447|NCT00538473|E1|Reported Event|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
418448|NCT00538512|B4|Baseline|Total|Total of all reporting groups
418449|NCT00538512|B3|Baseline|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
418450|NCT00538512|B2|Baseline|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
418451|NCT00538512|B1|Baseline|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
418452|NCT00538512|P3|Participant Flow|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
418453|NCT00538512|P2|Participant Flow|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
418454|NCT00538512|P1|Participant Flow|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
418455|NCT00538512|O3|Outcome|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
418675|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418503|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418456|NCT00538512|O2|Outcome|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
418457|NCT00538512|O1|Outcome|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
418458|NCT00538512|E3|Reported Event|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
418459|NCT00538512|E2|Reported Event|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
418460|NCT00538512|E1|Reported Event|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
418461|NCT00538590|B3|Baseline|Total|Total of all reporting groups
418462|NCT00538590|B2|Baseline|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
418463|NCT00538590|B1|Baseline|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
418464|NCT00538590|P2|Participant Flow|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
418465|NCT00538590|P1|Participant Flow|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
418466|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
418467|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
418468|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
418469|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
418470|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
418471|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
418472|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
418473|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
418474|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
418475|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
418476|NCT00538590|E2|Reported Event|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
418477|NCT00538590|E1|Reported Event|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
418478|NCT00538616|B3|Baseline|Total|Total of all reporting groups
418479|NCT00538616|B2|Baseline|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
418480|NCT00538616|B1|Baseline|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
418481|NCT00538616|P2|Participant Flow|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
418482|NCT00538616|P1|Participant Flow|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
418483|NCT00538616|O2|Outcome|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
418484|NCT00538616|O1|Outcome|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
418485|NCT00538616|E2|Reported Event|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
418486|NCT00538616|E1|Reported Event|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
418487|NCT00538629|B1|Baseline|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418488|NCT00538629|P1|Participant Flow|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418489|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418490|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418491|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418492|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418493|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418494|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418495|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418496|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418497|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418498|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418499|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418500|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418501|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418502|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418676|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418504|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418505|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418506|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418507|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418508|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418509|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418510|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418511|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418512|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418513|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418514|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418515|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418516|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418517|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418518|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418519|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418520|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418521|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418522|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418523|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418524|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418525|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418526|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418527|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418528|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418529|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418530|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418531|NCT00538629|E1|Reported Event|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
418532|NCT00538642|B3|Baseline|Total|Total of all reporting groups
418533|NCT00538642|B2|Baseline|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418534|NCT00538642|B1|Baseline|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418535|NCT00538642|P2|Participant Flow|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418536|NCT00538642|P1|Participant Flow|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418537|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418538|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418539|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418540|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418541|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418542|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418543|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418544|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418545|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418546|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418547|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418548|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418549|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418550|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418551|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418552|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418553|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418554|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418555|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418556|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418557|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418558|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418559|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418560|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418561|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418562|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418563|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418564|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418565|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418566|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418567|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418568|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418569|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418570|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418571|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418572|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418573|NCT00538642|E2|Reported Event|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
418574|NCT00538642|E1|Reported Event|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
418575|NCT00525421|B3|Baseline|Total|Total of all reporting groups
418576|NCT00525421|B2|Baseline|Placebo|Placebo : identical placebo tablets three times per day for 12 days
418577|NCT00525421|B1|Baseline|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
418578|NCT00525421|P2|Participant Flow|Placebo|Placebo : identical placebo tablets three times per day for 12 days
418579|NCT00525421|P1|Participant Flow|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
418580|NCT00525421|O2|Outcome|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
418581|NCT00525421|O1|Outcome|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
418582|NCT00525421|O2|Outcome|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
418583|NCT00525421|O1|Outcome|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
418584|NCT00525421|E2|Reported Event|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
418585|NCT00525421|E1|Reported Event|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
418586|NCT00525499|B5|Baseline|Total|Total of all reporting groups
418587|NCT00525499|B4|Baseline|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418588|NCT00525499|B3|Baseline|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418589|NCT00525499|B2|Baseline|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418590|NCT00525499|B1|Baseline|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
418591|NCT00525499|P4|Participant Flow|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418592|NCT00525499|P3|Participant Flow|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418593|NCT00525499|P2|Participant Flow|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418594|NCT00525499|P1|Participant Flow|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
418595|NCT00525499|O4|Outcome|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418596|NCT00525499|O3|Outcome|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418597|NCT00525499|O2|Outcome|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418598|NCT00525499|O1|Outcome|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
418599|NCT00525499|O4|Outcome|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418600|NCT00525499|O3|Outcome|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418601|NCT00525499|O2|Outcome|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418602|NCT00525499|O1|Outcome|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
418603|NCT00525499|E4|Reported Event|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418604|NCT00525499|E3|Reported Event|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418605|NCT00525499|E2|Reported Event|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
418606|NCT00525499|E1|Reported Event|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
418607|NCT00525512|B3|Baseline|Total|Total of all reporting groups
418608|NCT00525512|B2|Baseline|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418609|NCT00525512|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
418610|NCT00525512|P4|Participant Flow|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
418611|NCT00525512|P3|Participant Flow|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
437282|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
418612|NCT00525512|P2|Participant Flow|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418613|NCT00525512|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
418614|NCT00525512|O4|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
418615|NCT00525512|O3|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
418616|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418617|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418618|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
418619|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
418620|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
418621|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
418622|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
418623|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
418624|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
418625|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
418626|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
418627|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
418628|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
418629|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
418630|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
418631|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
418632|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418633|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418634|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418635|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418636|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418637|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418638|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418639|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418640|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418641|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418642|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418643|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418644|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418645|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418646|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418647|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418648|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418649|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418650|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418651|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418652|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418653|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418654|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418655|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418656|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418657|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418658|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418659|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418660|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418661|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418662|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418663|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418664|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418665|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418666|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418667|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418668|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418669|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418670|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418671|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418677|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418678|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418679|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418680|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418681|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418682|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418683|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418684|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418685|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418686|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418687|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418688|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418689|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418690|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418691|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418692|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418693|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418694|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418695|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418696|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418697|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418698|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418699|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418700|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418701|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418702|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418703|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418704|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418705|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418706|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418707|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418708|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418709|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418710|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418711|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418712|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418713|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418714|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418715|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418716|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418717|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418718|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418719|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418720|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418721|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418722|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418723|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418724|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418725|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418726|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418727|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418728|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418729|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418730|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418731|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418732|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418733|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418734|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418735|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418736|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418737|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437283|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
418738|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418739|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418740|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418741|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418742|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418743|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418744|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418745|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
418746|NCT00525512|E4|Reported Event|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
418747|NCT00525512|E3|Reported Event|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
418748|NCT00525512|E2|Reported Event|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
418749|NCT00525512|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
418750|NCT00525525|B3|Baseline|Total|Total of all reporting groups
418751|NCT00525525|B2|Baseline|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
418752|NCT00525525|B1|Baseline|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
418753|NCT00525525|P2|Participant Flow|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
418754|NCT00525525|P1|Participant Flow|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
418755|NCT00525525|O1|Outcome|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
418756|NCT00525525|O1|Outcome|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
418757|NCT00525525|O1|Outcome|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
418758|NCT00525525|E2|Reported Event|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
418759|NCT00525525|E1|Reported Event|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
418760|NCT00525603|B1|Baseline|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
418761|NCT00525603|P1|Participant Flow|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
418762|NCT00525603|O1|Outcome|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
418763|NCT00525603|E1|Reported Event|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
418764|NCT00525629|B3|Baseline|Total|Total of all reporting groups
418765|NCT00525629|B2|Baseline|Control Diet|"Isocaloric Diet with No Walnuts
Control: Control Diet with No Walnuts"
418766|NCT00525629|B1|Baseline|Walnut Diet|"48 Grams of Walnuts Daily
Walnuts: 48 Grams of Walnuts Daily"
418767|NCT00525629|P2|Participant Flow|Control Diet|Isocaloric Diet with no Nuts.
418768|NCT00525629|P1|Participant Flow|Walnut Diet|48g of walnuts per day
418769|NCT00525629|O2|Outcome|Control Diet|"Isocaloric Diet with No Walnuts
Control: Control Diet with No Walnuts"
418770|NCT00525629|O1|Outcome|Walnut Diet|"48 Grams of Walnuts Daily
Walnuts: 48 Grams of Walnuts Daily"
418771|NCT00525629|E2|Reported Event|Control Diet|Isocaloric Diet with no Nuts.
418772|NCT00525629|E1|Reported Event|Walnut Diet|48g of walnuts per day
418773|NCT00525733|B3|Baseline|Total|Total of all reporting groups
418806|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418807|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418808|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418809|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418810|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418811|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418774|NCT00525733|B2|Baseline|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID
darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)
Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)
Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
418775|NCT00525733|B1|Baseline|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD
darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
418776|NCT00525733|P2|Participant Flow|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID
darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)
Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)
Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
418777|NCT00525733|P1|Participant Flow|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD
darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
418778|NCT00525733|O2|Outcome|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID
darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)
Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)
Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
418779|NCT00525733|O1|Outcome|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD
darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
418780|NCT00525733|E2|Reported Event|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID
darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)
Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)
Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
418781|NCT00525733|E1|Reported Event|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD
darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
418782|NCT00525798|B3|Baseline|Total|Total of all reporting groups
418783|NCT00525798|B2|Baseline|Placebo|1 tablet of placebo daily
418784|NCT00525798|B1|Baseline|SMC021|1 tablet of 0,80 mg SMC021 daily
418785|NCT00525798|P2|Participant Flow|Placebo|1 tablet of placebo daily
418786|NCT00525798|P1|Participant Flow|SMC021|1 tablet of 0,80 mg SMC021 daily
418787|NCT00525798|O2|Outcome|Placebo|1 tablet of placebo daily
418788|NCT00525798|O1|Outcome|SMC021|1 tablet of 0,80 mg SMC021 daily
418789|NCT00525798|O2|Outcome|Placebo|1 tablet of placebo daily
418790|NCT00525798|O1|Outcome|SMC021|1 tablet of 0,80 mg SMC021 daily
418791|NCT00525798|E2|Reported Event|Placebo|1 tablet of placebo daily
418792|NCT00525798|E1|Reported Event|SMC021|1 tablet of 0,80 mg SMC021 daily
418793|NCT00525824|B5|Baseline|Total|Total of all reporting groups
418794|NCT00525824|B4|Baseline|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418795|NCT00525824|B3|Baseline|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418796|NCT00525824|B2|Baseline|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418797|NCT00525824|B1|Baseline|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418798|NCT00525824|P4|Participant Flow|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418799|NCT00525824|P3|Participant Flow|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418800|NCT00525824|P2|Participant Flow|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418801|NCT00525824|P1|Participant Flow|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418802|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418803|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418804|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418805|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418812|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418813|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418814|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418815|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418816|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418817|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418818|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418819|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418820|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418821|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418822|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418823|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418824|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418825|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418826|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418827|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418828|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418829|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418830|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418831|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418832|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418833|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418834|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418835|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418836|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418837|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418838|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418839|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418840|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418841|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418842|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418843|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418844|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418845|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418846|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418847|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418848|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418849|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418850|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
418851|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
418852|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
418853|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
418854|NCT00525824|E8|Reported Event|Simva 80 mg + Eze 10 mg|Simvastatin 80 mg + Ezetimibe 10 mg
418855|NCT00525824|E7|Reported Event|Simva 40 mg + Eze 10 mg|Simvastatin 40 mg + Ezetimibe 10 mg
418856|NCT00525824|E6|Reported Event|Rosu 20 mg + Eze 10 mg|Rosuvastatin 20 mg + Ezetimibe 10 mg
418857|NCT00525824|E5|Reported Event|Rosu 10 mg + Eze 10 mg|Rosuvastatin 10 mg + Ezetimibe 10 mg
418858|NCT00525824|E4|Reported Event|Simvastatin 80 mg|Simvastatin 80 mg Monotherapy arm
418859|NCT00525824|E3|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg Monotherapy arm
418860|NCT00525824|E2|Reported Event|Rosuvastatin 20 mg|Rosuvastatin 20 mg Monotherapy arm
418861|NCT00525824|E1|Reported Event|Rosuvastatin 10 mg|Rosuvastatin 10 mg Monotherapy arm
418862|NCT00525837|B1|Baseline|Varenicline|
418863|NCT00525837|P1|Participant Flow|Varenicline|
418864|NCT00525837|O1|Outcome|Varenicline|
418865|NCT00525837|E1|Reported Event|Varenicline|
418866|NCT00525876|B3|Baseline|Total|Total of all reporting groups
418867|NCT00525876|B2|Baseline|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
418897|NCT00526058|E1|Reported Event|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
418899|NCT00526097|B2|Baseline|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418868|NCT00525876|B1|Baseline|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
418869|NCT00525876|P2|Participant Flow|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
418870|NCT00525876|P1|Participant Flow|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
418871|NCT00525876|O2|Outcome|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
418872|NCT00525876|O1|Outcome|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
418873|NCT00525876|E2|Reported Event|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
418874|NCT00525876|E1|Reported Event|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
418875|NCT00525902|B1|Baseline|Adalimumab|
418876|NCT00525902|P1|Participant Flow|Adalimumab|
418877|NCT00525902|O1|Outcome|Adalimumab|
418878|NCT00525902|O1|Outcome|Adalimumab|
418879|NCT00525902|E1|Reported Event|Adalimumab|
418880|NCT00525915|B3|Baseline|Total|Total of all reporting groups
418881|NCT00525915|B2|Baseline|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
418882|NCT00525915|B1|Baseline|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
418883|NCT00525915|P2|Participant Flow|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
418884|NCT00525915|P1|Participant Flow|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
418885|NCT00525915|O2|Outcome|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
418886|NCT00525915|O1|Outcome|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
418887|NCT00525915|E2|Reported Event|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
418888|NCT00525915|E1|Reported Event|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
418889|NCT00526058|B3|Baseline|Total|Total of all reporting groups
418890|NCT00526058|B2|Baseline|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
418891|NCT00526058|B1|Baseline|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
418892|NCT00526058|P2|Participant Flow|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
418893|NCT00526058|P1|Participant Flow|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
418894|NCT00526058|O2|Outcome|Futura|Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
418895|NCT00526058|O1|Outcome|Secura|Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
418896|NCT00526058|E2|Reported Event|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
418900|NCT00526097|B1|Baseline|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418901|NCT00526097|P2|Participant Flow|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418902|NCT00526097|P1|Participant Flow|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418903|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418904|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418905|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418906|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418907|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418908|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418909|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418910|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418911|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418912|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418913|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418914|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418915|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418916|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418917|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418918|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418919|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418920|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418921|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418922|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418923|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418924|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418925|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418926|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418927|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418928|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418929|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418930|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418931|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418932|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418933|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418934|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418935|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418936|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418937|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418938|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418939|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418940|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418941|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418942|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418943|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418944|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418945|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418946|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418947|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418948|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418949|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418950|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418951|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418952|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418953|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418954|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418955|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418956|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418957|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418958|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418959|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418960|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418961|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418962|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418963|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418964|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418965|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418966|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418967|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418968|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418969|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418970|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418971|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418972|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418973|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418974|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418975|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418976|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418977|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418978|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418979|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418980|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418981|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418982|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418983|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418984|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418985|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418986|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418987|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418988|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418989|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418990|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418991|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418992|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418993|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418994|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418995|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418996|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418997|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
418998|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
418999|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419000|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419001|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419002|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419003|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419004|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419005|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419006|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419007|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419008|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419009|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419010|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419011|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419012|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419013|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419014|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419015|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419016|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419017|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419018|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419019|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419020|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419021|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419022|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419023|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419024|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419025|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419026|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419027|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419028|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419029|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419030|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419031|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419032|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419033|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419034|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419035|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419036|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419037|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419038|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419039|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419040|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419041|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419042|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419043|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419044|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419045|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419046|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419047|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419048|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419049|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419050|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419051|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419052|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419053|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419054|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419055|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419056|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419057|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419058|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419059|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419060|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419061|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419062|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419063|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419064|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419065|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419066|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419067|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419068|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419069|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419070|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419071|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419072|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419073|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419074|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419075|NCT00526097|E2|Reported Event|Bisacodyl|Two bisacodyl 5 mg tablets once daily
419076|NCT00526097|E1|Reported Event|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
419077|NCT00526110|B3|Baseline|Total|Total of all reporting groups
419078|NCT00526110|B2|Baseline|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
419079|NCT00526110|B1|Baseline|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
419080|NCT00526110|P2|Participant Flow|Phase II: Docetaxel MTD 50 mg/m^2|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
419081|NCT00526110|P1|Participant Flow|Phase I: Dose Escalation|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
419082|NCT00526110|O1|Outcome|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
419083|NCT00526110|O1|Outcome|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
419084|NCT00526110|O1|Outcome|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
419085|NCT00526110|E2|Reported Event|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
419136|NCT00526474|B1|Baseline|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
420263|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420737|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
419086|NCT00526110|E1|Reported Event|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
419087|NCT00526123|B3|Baseline|Total|Total of all reporting groups
419088|NCT00526123|B2|Baseline|Split-tip|split-tip hemodialysis catheter
419089|NCT00526123|B1|Baseline|Symmetric Tip|symmetric tip hemodialysis catheter
419090|NCT00526123|P2|Participant Flow|Split-tip|split-tip hemodialysis catheter
419091|NCT00526123|P1|Participant Flow|Symmetric Tip|symmetric tip hemodialysis catheter
419092|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
419093|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
419094|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
419095|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
419096|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
419097|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
419098|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
419099|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
419100|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
419101|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
419102|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
419103|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
419104|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
419105|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
419106|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
419107|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
419108|NCT00526123|E2|Reported Event|Split-tip|split-tip hemodialysis catheter
419109|NCT00526123|E1|Reported Event|Symmetric Tip|symmetric tip hemodialysis catheter
419110|NCT00526162|B1|Baseline|1|
419111|NCT00526162|P1|Participant Flow|1|
419112|NCT00526162|O1|Outcome|1|
419113|NCT00526162|O1|Outcome|1|
419114|NCT00526162|O1|Outcome|1|
419115|NCT00526188|B1|Baseline|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
419116|NCT00526188|P1|Participant Flow|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
419117|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
419118|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
419119|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
419120|NCT00526188|E1|Reported Event|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
419121|NCT00526227|B1|Baseline|1|
419122|NCT00526227|P1|Participant Flow|1|
419123|NCT00526227|O1|Outcome|1|
419124|NCT00526227|O1|Outcome|1|
419125|NCT00526227|O1|Outcome|1|
419126|NCT00526292|B1|Baseline|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
419127|NCT00526292|P1|Participant Flow|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
419128|NCT00526292|O1|Outcome|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
419129|NCT00526292|E1|Reported Event|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
419130|NCT00526331|B1|Baseline|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
419131|NCT00526331|P1|Participant Flow|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
419132|NCT00526331|O1|Outcome|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
419133|NCT00526331|E1|Reported Event|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
419134|NCT00526474|B3|Baseline|Total|Total of all reporting groups
419135|NCT00526474|B2|Baseline|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419615|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419137|NCT00526474|P2|Participant Flow|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419138|NCT00526474|P1|Participant Flow|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419139|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419140|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419141|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419142|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419143|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419144|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419145|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419146|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419147|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419148|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419149|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419150|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419151|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419152|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419153|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419154|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419155|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419156|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419157|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419158|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419159|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419160|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419161|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419162|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419163|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419164|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419165|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419166|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419616|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419167|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419168|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419169|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419170|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419171|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419172|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419173|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419174|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419175|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419176|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419177|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419178|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419179|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419180|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419181|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419182|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419183|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419184|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419185|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419186|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419187|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419188|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419189|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419190|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419191|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419192|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419193|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419194|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419195|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419196|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419617|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419197|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419198|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419199|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419200|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419201|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419202|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419203|NCT00526474|E2|Reported Event|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419204|NCT00526474|E1|Reported Event|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
419205|NCT00526630|B1|Baseline|All Participants|Participants were randomized to receive both MPD and placebo.
419206|NCT00526630|P2|Participant Flow|Placebo Then MPD|First group treated with placebo then MPD
419207|NCT00526630|P1|Participant Flow|MPD Then Placebo|First group treated with MPD then placebo
419208|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
419209|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
419210|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
419211|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
419212|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
419213|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
419214|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
419215|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
419216|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
419217|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
419218|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
419219|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
419220|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
419221|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
419222|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
419223|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
419224|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
419225|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
419226|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
419227|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
419228|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
419229|NCT00526630|O3|Outcome|Baseline|Baseline gait composite scores
419230|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
419231|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
419232|NCT00526630|E2|Reported Event|2. Placebo|"Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
Placebo: Participants will be given placebo instead of active MPD."
419233|NCT00526630|E1|Reported Event|1. MPD|"Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
Methylphenidate (MPD): Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day."
419234|NCT00526669|B1|Baseline|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419235|NCT00526669|P2|Participant Flow|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419236|NCT00526669|P1|Participant Flow|Lapatinib|Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
420264|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
419237|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419238|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419239|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419240|NCT00526669|O1|Outcome|Overall Study Arm|
419241|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419242|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419243|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419244|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419245|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419246|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419247|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419248|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419249|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419250|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419251|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419272|NCT00527514|E4|Reported Event|Amlodipine 10 mg and Olmesartan 40 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
419252|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419253|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419254|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419255|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419256|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419257|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419258|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419259|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419260|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419261|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419262|NCT00526669|O1|Outcome|Lapatinib|Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
419263|NCT00526669|E1|Reported Event|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
419264|NCT00527514|B1|Baseline|Amlodipine and Olmesartan, if Necessary|Week 1-3 all participants: Amlodipine 5mg; Week 4-6 Amlodipine 5 mg/olmesartan 20 mg if mean SBP >= 120/80 mm Hg; Week 7-9 Amlodipine 5 mg/ olmesartan 40 mg if mean SBP >= 120/80 mm Hg; Week 10-12 Amlodipine 10 mg/olmesartan 40 mg if mean SBP >= 120/80 mm Hg
419265|NCT00527514|P1|Participant Flow|Amlodipine and Olmesartan, if Necessary|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
419266|NCT00527514|O1|Outcome|Group 4 - Aml 10 mg + Olm 40 mg|
419267|NCT00527514|O1|Outcome|Group 3 - Aml 5 mg + Olm 40 mg|Participants from Group 2 who did not meet the blood pressure goal after 3 weeks were titrated to Aml 5 mg + olmesartan 40mg.
419268|NCT00527514|O1|Outcome|Group 2 - Aml 5 mg + Olmesartan 20 mg|Participants from Group 1 who did not meet the blood pressure goal after 3 weeks were titrated to Aml 5 mg + olmesartan 20 mg.
419269|NCT00527514|O1|Outcome|Group 1 Amlodipine 5 mg|All participants started the Active Treatment period with 5 mg of amlodipine for 3 weeks.
419270|NCT00527514|O1|Outcome|Overall Active Treatment Period|
419271|NCT00527514|O1|Outcome|Overall Active Treatment Period|
419329|NCT00527605|E1|Reported Event|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419618|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419273|NCT00527514|E3|Reported Event|Amlodipine 5mg and Olmesartan 40 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
419274|NCT00527514|E2|Reported Event|Amlodipine 5mg and Olmesartan 20 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
419275|NCT00527514|E1|Reported Event|Amlodipine 5 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
419276|NCT00527566|B1|Baseline|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
419277|NCT00527566|P1|Participant Flow|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
419278|NCT00527566|O2|Outcome|Non-treatment Phase|The non-treatment phase consists of the wash-out phase and the safety monitoring phase.
419279|NCT00527566|O1|Outcome|Mepolizumab (Treatment Phase)|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
419280|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
419281|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
419282|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
419283|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
419284|NCT00527566|E1|Reported Event|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
419285|NCT00527592|B1|Baseline|Travoprost/Latanoprost|Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
419286|NCT00527592|P1|Participant Flow|Travoprost/Latanoprost|Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
419287|NCT00527592|O2|Outcome|Latanoprost|One drop in the study eye, single dose
419288|NCT00527592|O1|Outcome|Travoprost|One drop in the study eye, single dose
419289|NCT00527592|E2|Reported Event|Latanoprost|One drop in the study eye, single dose
419290|NCT00527592|E1|Reported Event|Travoprost|One drop in the study eye, single dose
419291|NCT00527605|B3|Baseline|Total|Total of all reporting groups
419292|NCT00527605|B2|Baseline|Placebo|Matching oral placebo once a day for 6 months
419293|NCT00527605|B1|Baseline|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419294|NCT00527605|P2|Participant Flow|Placebo|Matching oral placebo once a day for 6 months
419295|NCT00527605|P1|Participant Flow|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419296|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419297|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419298|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419299|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419300|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419301|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419302|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419303|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419304|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419305|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419306|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419307|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419308|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419309|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419310|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419311|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419312|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419313|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419314|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419315|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419316|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419317|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419318|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419319|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419320|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419321|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419322|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419323|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419324|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419325|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419326|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
419327|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
419328|NCT00527605|E2|Reported Event|Placebo|Matching oral placebo once a day for 6 months
419330|NCT00527618|B1|Baseline|Entire Study Population|This includes all 34 participants who were randomized. A subset of 28 participants were included in the analysis since only 28 participants contributed samples on both arms of the crossover study.
419331|NCT00527618|P2|Participant Flow|Valacyclovir Followed by Acyclovir|Valacyclovir 1000 mg twice daily, followed by a two-week washout period, then acyclovir 400 mg twice daily
419332|NCT00527618|P1|Participant Flow|Acyclovir Followed by Valacyclovir|Acyclovir 400 mg twice daily, followed by a two-week washout period, then valacyclovir 1000 mg twice daily
419333|NCT00527618|O1|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily
419334|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
419335|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
419336|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
419337|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
419338|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
419339|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
419340|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
419341|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
419342|NCT00527618|E2|Reported Event|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
419343|NCT00527618|E1|Reported Event|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
419344|NCT00527722|B3|Baseline|Total|Total of all reporting groups
419345|NCT00527722|B2|Baseline|No Pleural Plug|The standard lung biopsy without placement of the plug.
419346|NCT00527722|B1|Baseline|Pleural Plug|Experimental lung plug after the lung biopsy.
419347|NCT00527722|P2|Participant Flow|No Pleural Plug|The standard lung biopsy without placement of the plug.
419348|NCT00527722|P1|Participant Flow|Pleural Plug|Experimental lung plug after the lung biopsy.
419349|NCT00527722|O2|Outcome|No Pleural Plug|The standard lung biopsy without placement of the plug.
419350|NCT00527722|O1|Outcome|Pleural Plug|Experimental lung plug after the lung biopsy.
419351|NCT00527722|E2|Reported Event|No Pleural Plug|The standard lung biopsy without placement of the plug.
419352|NCT00527722|E1|Reported Event|Pleural Plug|Experimental lung plug after the lung biopsy.
419353|NCT00527735|B4|Baseline|Total|Total of all reporting groups
419354|NCT00527735|B3|Baseline|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who experienced clinical benefit on treatment phase without intolerable toxicity could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419355|NCT00527735|B2|Baseline|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419356|NCT00527735|B1|Baseline|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419357|NCT00527735|P3|Participant Flow|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419358|NCT00527735|P2|Participant Flow|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419465|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419359|NCT00527735|P1|Participant Flow|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease (PD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419360|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419361|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419362|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419363|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419364|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419365|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419366|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419367|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419368|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
420265|NCT00529087|O3|Outcome|Placebo|Once daily
419369|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419370|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419371|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419372|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419373|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419374|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419375|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419376|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419377|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419378|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419409|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419379|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419380|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419381|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419382|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419383|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419384|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419385|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419386|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419387|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419388|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419611|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419389|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419390|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419391|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419392|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419393|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419394|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419395|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419396|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419397|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419398|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419612|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419399|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419400|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419401|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419402|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419403|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419404|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419405|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419406|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419407|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419408|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
420266|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
419410|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419411|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419412|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419413|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419414|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419415|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419416|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419417|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419418|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419419|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
420267|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
419420|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419421|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419422|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419423|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419424|NCT00527735|E6|Reported Event|Placebo + Paclitaxel/Carboplatin SCLC|During induction, participants with SCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419425|NCT00527735|E5|Reported Event|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC|During induction, participants with SCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419426|NCT00527735|E4|Reported Event|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC|During induction, participants with small-cell lung cancer (SCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419427|NCT00527735|E3|Reported Event|Placebo + Paclitaxel/Carboplatin NSCLC|During induction, participants with NSCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
419428|NCT00527735|E2|Reported Event|Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC|During induction, participants with NSCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419461|NCT00527826|B1|Baseline|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419462|NCT00527826|P2|Participant Flow|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419463|NCT00527826|P1|Participant Flow|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419429|NCT00527735|E1|Reported Event|Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC|During induction, participants with nonsmall-cell lung cancer (NSCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered intravenously (IV) over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
419430|NCT00527748|B1|Baseline|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:
Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.
Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks."
419431|NCT00527748|P1|Participant Flow|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:
Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.
Reassessment will be done at six weeks and 10 weeks."
419432|NCT00527748|O1|Outcome|Standard of Care|"Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:
Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.
Reassessment will be done at six weeks and 10 weeks."
419433|NCT00527748|E1|Reported Event|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:
Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.
Reassessment will be done at six weeks and 10 weeks."
419434|NCT00527787|B3|Baseline|Total|Total of all reporting groups
419435|NCT00527787|B2|Baseline|Naproxen|Naproxen 500 mg
419436|NCT00527787|B1|Baseline|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419437|NCT00527787|P2|Participant Flow|Naproxen|Naproxen 500 mg
419438|NCT00527787|P1|Participant Flow|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419439|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
419440|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419441|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
419442|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419443|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
419444|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419445|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
419446|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419447|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
419448|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419449|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
419450|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419451|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
419452|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419453|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
419454|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419455|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
419456|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419457|NCT00527787|E2|Reported Event|Naproxen|Naproxen 500 mg
419458|NCT00527787|E1|Reported Event|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
419459|NCT00527826|B3|Baseline|Total|Total of all reporting groups
419460|NCT00527826|B2|Baseline|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419464|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419466|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419467|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419468|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419469|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419470|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419471|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419472|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419473|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419474|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419475|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419476|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419477|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419478|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419479|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419480|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419481|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419482|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419483|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419484|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419485|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419486|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419487|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419488|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419489|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419490|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419491|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419492|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419493|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419494|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419495|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419496|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419497|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
419498|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419499|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
420268|NCT00529087|O3|Outcome|Placebo|Once daily
437284|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
419500|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419501|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419502|NCT00527826|O3|Outcome|FP 500 µg|Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
419503|NCT00527826|O2|Outcome|Sal 50 µg|Salmeterol xinafoate (Sal) 50 µg BID (morning and evening) from a separate inhaler (SEVERENT Diskus)
419504|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419505|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419506|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419507|NCT00527826|E2|Reported Event|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
419508|NCT00527826|E1|Reported Event|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
419509|NCT00527878|B1|Baseline|Patients|
419510|NCT00527878|P2|Participant Flow|Ranitidine/Placebo|Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive ranitidine for 12 months followed by 12 months of the ranitidine.
419511|NCT00527878|P1|Participant Flow|Placebo/Ranitidine|Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive placebo for 12 months followed by 12 months of the ranitidine.
419512|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
419513|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
419514|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
419515|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
419516|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
419517|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
419518|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
419519|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
419520|NCT00527878|E2|Reported Event|Ranitidine|This was a crossover study and patients received 12 months of ranitidine and 12 months of placebo, unless they terminated the study.
419521|NCT00527878|E1|Reported Event|Placebo|this was a crossover study and patients received both placebo and study drug (ranitidine), both of which for 12 months, unless they terminated the study.
419522|NCT00527904|B1|Baseline|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
419523|NCT00527904|P1|Participant Flow|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
419524|NCT00527904|O1|Outcome|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
419525|NCT00527904|E1|Reported Event|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
419526|NCT00527943|B3|Baseline|Total|Total of all reporting groups
419527|NCT00527943|B2|Baseline|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419528|NCT00527943|B1|Baseline|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419529|NCT00527943|P2|Participant Flow|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419530|NCT00527943|P1|Participant Flow|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419531|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419613|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419614|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419532|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419533|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419534|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419535|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419536|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419537|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419538|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419539|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419540|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419541|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419542|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419543|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419544|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419545|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419546|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419547|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419548|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419549|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419550|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419551|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419552|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419553|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419554|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419555|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419556|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419557|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419558|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419559|NCT00527943|E2|Reported Event|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419560|NCT00527943|E1|Reported Event|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
419561|NCT00527982|B3|Baseline|Total|Total of all reporting groups
419562|NCT00527982|B2|Baseline|No Treatment|
419563|NCT00527982|B1|Baseline|Celecoxib Treatment|Celecoxib 600 mg orally daily
419564|NCT00527982|P2|Participant Flow|No Treatment|
419565|NCT00527982|P1|Participant Flow|Celecoxib Treatment|Celecoxib 600 mg orally daily
419566|NCT00527982|O2|Outcome|No Treatment|
419567|NCT00527982|O1|Outcome|Celecoxib Treatment|Celecoxib 600 mg orally daily
419568|NCT00527982|E2|Reported Event|No Treatment|
419569|NCT00527982|E1|Reported Event|Celecoxib Treatment|Celecoxib 600 mg orally daily
419570|NCT00528021|B5|Baseline|Total|Total of all reporting groups
419571|NCT00528021|B4|Baseline|Vehicle|
419572|NCT00528021|B3|Baseline|12.5% BGC20-0582|
419573|NCT00528021|B2|Baseline|10% BGC20-0582|
419574|NCT00528021|B1|Baseline|2.5% BGC20-0582|
419575|NCT00528021|P4|Participant Flow|Vehicle|
419576|NCT00528021|P3|Participant Flow|12.5% BGC20-0582|
419577|NCT00528021|P2|Participant Flow|10% BGC20-0582|
419578|NCT00528021|P1|Participant Flow|2.5% BGC20-0582|
419579|NCT00528021|O4|Outcome|Vehicle|
419580|NCT00528021|O3|Outcome|12.5% BGC20-0582|
419581|NCT00528021|O2|Outcome|10% BGC20-0582|
419582|NCT00528021|O1|Outcome|2.5% BGC20-0582|
419583|NCT00528021|E4|Reported Event|Vehicle|
419584|NCT00528021|E3|Reported Event|12.5% BGC20-0582|
419585|NCT00528021|E2|Reported Event|10% BGC20-0582|
419586|NCT00528021|E1|Reported Event|2.5% BGC20-0582|
419587|NCT00528112|B3|Baseline|Total|Total of all reporting groups
419588|NCT00528112|B2|Baseline|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419589|NCT00528112|B1|Baseline|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419590|NCT00528112|P2|Participant Flow|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
419591|NCT00528112|P1|Participant Flow|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
419592|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419593|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419594|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419595|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419596|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419597|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419598|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419599|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419600|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419601|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419602|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419603|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419604|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419605|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419606|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419607|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419608|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419609|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419610|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
437285|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
419619|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419620|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419621|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419622|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419623|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419624|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419625|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419626|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419627|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419628|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419629|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419630|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419631|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419632|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419633|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419634|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419635|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419636|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419637|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419638|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419639|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
419640|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
419641|NCT00528112|E3|Reported Event|LCS16, up to 5 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
419642|NCT00528112|E2|Reported Event|LCS16, up to 3 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 3 years.
419643|NCT00528112|E1|Reported Event|LCS12, up to 3 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
419644|NCT00528190|B3|Baseline|Total|Total of all reporting groups
419645|NCT00528190|B2|Baseline|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
419646|NCT00528190|B1|Baseline|Itraconazole|"Itraconazole 5mg/kg/day
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
419647|NCT00528190|P2|Participant Flow|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
419648|NCT00528190|P1|Participant Flow|Itraconazole|"Itraconazole 5mg/kg/day
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
419649|NCT00528190|O2|Outcome|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
419650|NCT00528190|O1|Outcome|Itraconazole|"Itraconazole 5mg/kg/day
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
419651|NCT00528190|E2|Reported Event|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
419652|NCT00528190|E1|Reported Event|Itraconazole|"Itraconazole 5mg/kg/day
Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
419653|NCT00528268|B3|Baseline|Total|Total of all reporting groups
419654|NCT00528268|B2|Baseline|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies
Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
419655|NCT00528268|B1|Baseline|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies
Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
419656|NCT00528268|P2|Participant Flow|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies
Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
419657|NCT00528268|P1|Participant Flow|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies
Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
419658|NCT00528268|O2|Outcome|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies
Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
419659|NCT00528268|O1|Outcome|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies
Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
419660|NCT00528268|E2|Reported Event|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies
Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
419661|NCT00528268|E1|Reported Event|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies
Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
419662|NCT00528372|B10|Baseline|Total|Total of all reporting groups
419663|NCT00528372|B9|Baseline|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419664|NCT00528372|B8|Baseline|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419665|NCT00528372|B7|Baseline|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419666|NCT00528372|B6|Baseline|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419667|NCT00528372|B5|Baseline|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419668|NCT00528372|B4|Baseline|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks.
Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
419669|NCT00528372|B3|Baseline|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419670|NCT00528372|B2|Baseline|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419671|NCT00528372|B1|Baseline|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419672|NCT00528372|P9|Participant Flow|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419673|NCT00528372|P8|Participant Flow|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419674|NCT00528372|P7|Participant Flow|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419675|NCT00528372|P6|Participant Flow|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419676|NCT00528372|P5|Participant Flow|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419677|NCT00528372|P4|Participant Flow|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419678|NCT00528372|P3|Participant Flow|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419812|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
439023|NCT00584220|O2|Outcome|Alphafilcon A Toric|contact lenses
419679|NCT00528372|P2|Participant Flow|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419680|NCT00528372|P1|Participant Flow|Group 1: Dapagliflozin Placebo|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419681|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419682|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419683|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419684|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419685|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419686|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419687|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419688|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419689|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419690|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks.
Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
419691|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419692|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419693|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419694|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419695|NCT00528372|O9|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419696|NCT00528372|O8|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419697|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419698|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419699|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, PM, once each evening for up to 102 weeks.
Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
419813|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419700|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419701|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419702|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419703|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419704|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419705|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419706|NCT00528372|O9|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419707|NCT00528372|O8|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419708|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419709|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419710|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419711|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419712|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419713|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419714|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo, AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419715|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419716|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419717|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419718|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419719|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419720|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419721|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419722|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419723|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419724|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419725|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419726|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419727|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419728|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419729|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419730|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419731|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419732|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419733|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419734|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419735|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419736|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419737|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419738|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419739|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419740|NCT00528372|O3|Outcome|Group 1: Dapaglifozon, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
439024|NCT00584220|O1|Outcome|Senofilcon A Toric|contact lenses
419741|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with hemoglobin A1c (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419742|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419743|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419744|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419745|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419746|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks.
Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
419747|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks.
Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
419748|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks.
Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
419749|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|"Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks.
Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
419750|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419751|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419752|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419753|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419754|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419755|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419756|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419757|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419758|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419759|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419814|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419815|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419760|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with hemoglobin A1c (HbA1c) ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419761|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419762|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419763|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419764|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419765|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419766|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419767|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419768|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419769|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419770|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419771|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419772|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419773|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419774|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419775|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419776|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419777|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419778|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419816|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419779|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
419780|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419781|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419782|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419783|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419784|NCT00528372|E7|Reported Event|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419785|NCT00528372|E6|Reported Event|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419786|NCT00528372|E5|Reported Event|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419787|NCT00528372|E4|Reported Event|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks.
Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
419788|NCT00528372|E3|Reported Event|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419789|NCT00528372|E2|Reported Event|Group 1: Dapagliflozin, 2.5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.
Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
419790|NCT00528372|E1|Reported Event|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
419791|NCT00528398|B1|Baseline|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
419792|NCT00528398|P1|Participant Flow|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
419793|NCT00528398|O1|Outcome|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
419794|NCT00528398|O1|Outcome|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
419795|NCT00528398|E1|Reported Event|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
419796|NCT00528411|B4|Baseline|Total|Total of all reporting groups
419797|NCT00528411|B3|Baseline|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419798|NCT00528411|B2|Baseline|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419799|NCT00528411|B1|Baseline|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus Clopidogrel placebo loading and od maintenance doses
419800|NCT00528411|P3|Participant Flow|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
419801|NCT00528411|P2|Participant Flow|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg Twice Daily (od), plus ticagrelor placebo loading and Once Daily (bd) maintenance doses
419802|NCT00528411|P1|Participant Flow|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
419803|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419804|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419805|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419806|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419807|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419808|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419809|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419810|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419811|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
439616|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
419817|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419818|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419819|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419820|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419821|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419822|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419823|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419824|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419825|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419826|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419827|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419828|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419829|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419830|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419831|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419832|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419833|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419834|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419835|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419836|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419837|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419838|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419839|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419840|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419841|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419842|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419843|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419844|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419845|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419846|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419847|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419848|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419849|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419850|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419851|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419852|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419853|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419854|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419855|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419856|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419857|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419858|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419859|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419860|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
439617|NCT00577135|O4|Outcome|High Intensification|
419861|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419862|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419863|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419864|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419865|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419866|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419867|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419868|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419869|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419870|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419871|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419872|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419873|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419874|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419875|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419876|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419877|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419878|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419879|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419880|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419881|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419882|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419883|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419884|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419885|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419886|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419887|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419888|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419889|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419890|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419891|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419892|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419893|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419894|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419895|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419896|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419897|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419898|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419899|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419900|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419901|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419902|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419903|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419904|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419905|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419906|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419907|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419908|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419909|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419910|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419911|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419912|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419913|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419914|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419915|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419916|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419917|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419918|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419919|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419920|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419921|NCT00528411|E3|Reported Event|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419922|NCT00528411|E2|Reported Event|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
419923|NCT00528411|E1|Reported Event|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
419924|NCT00528424|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
419925|NCT00528424|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
419926|NCT00528424|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
419927|NCT00528424|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
419928|NCT00528450|B1|Baseline|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
419929|NCT00528450|P1|Participant Flow|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
419930|NCT00528450|O1|Outcome|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
419931|NCT00528450|E1|Reported Event|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
419932|NCT00528528|B5|Baseline|Total|Total of all reporting groups
419933|NCT00528528|B4|Baseline|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419934|NCT00528528|B3|Baseline|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419935|NCT00528528|B2|Baseline|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419936|NCT00528528|B1|Baseline|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419937|NCT00528528|P4|Participant Flow|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419938|NCT00528528|P3|Participant Flow|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419939|NCT00528528|P2|Participant Flow|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419960|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419940|NCT00528528|P1|Participant Flow|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419941|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419942|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419943|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419944|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419945|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419946|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419947|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419948|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419949|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419950|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419951|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419952|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419953|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419954|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419955|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419956|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419957|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419958|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419959|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419961|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419962|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419963|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419964|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419965|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419966|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419967|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419968|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419969|NCT00528528|E4|Reported Event|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419970|NCT00528528|E3|Reported Event|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419971|NCT00528528|E2|Reported Event|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
419972|NCT00528528|E1|Reported Event|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
419973|NCT00528541|B3|Baseline|Total|Total of all reporting groups
419974|NCT00528541|B2|Baseline|Dysport®|botulinum toxin type A (Dysport®)
419975|NCT00528541|B1|Baseline|BOTOX®|botulinum toxin type A (BOTOX®)
419976|NCT00528541|P2|Participant Flow|Dysport®|botulinum toxin type A (Dysport®)
419977|NCT00528541|P1|Participant Flow|BOTOX®|botulinum toxin type A (BOTOX®)
419978|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
419979|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
419980|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
419981|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
419982|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
419983|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
419984|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
419985|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
419986|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
419987|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
419988|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
419989|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
419990|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
419991|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
419992|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
419993|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
419994|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
419995|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
419996|NCT00528541|E2|Reported Event|Dysport®|botulinum toxin type A (Dysport®)
419997|NCT00528541|E1|Reported Event|BOTOX®|botulinum toxin type A (BOTOX®)
419998|NCT00528567|B3|Baseline|Total|Total of all reporting groups
419999|NCT00528567|B2|Baseline|Chemotherapy|Participants randomized to receive chemotherapy alone
420000|NCT00528567|B1|Baseline|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420083|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420001|NCT00528567|P2|Participant Flow|Chemotherapy|"Participants randomized to receive chemotherapy alone.
For patients randomized to the chemotherapy alone arm, investigators could select from one of three chemotherapy regimens. After completing chemotherapy (treatment period 1) patients entered a post-treatment surveillance period for the remainder of the first year after randomization (treatment period 2).
At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study."
420002|NCT00528567|P1|Participant Flow|Bevacizumab and Chemotherapy|"Participants randomized to receive bevacizumab and chemotherapy.
For these patients, bevacizumab was given in combination with chemotherapy at a dose of 5 mg/kg/week equivalent using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy selected. After completing chemotherapy + bevacizumab (treatment period 1), patients in this arm received bevacizumab monotherapy up to a total duration of 1 year (treatment period 2).
At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study."
420003|NCT00528567|O4|Outcome|Chemotherapy (>18 Months)|Occurring in participants who received chemotherapy alone, more than 18 months after first dose
420004|NCT00528567|O3|Outcome|Bevacizumab and Chemotherapy (>18 Months)|Occurring in participants who received bevacizumab and chemotherapy, more than 18 months after first dose
420005|NCT00528567|O2|Outcome|Chemotherapy (0-18 Months)|Occurring in participants who received chemotherapy alone, 0-18 months after first dose
420006|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy (0-18 Months)|Occurring in participants who received bevacizumab and chemotherapy, 0-18 months after first dose
420007|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
420008|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420009|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
420010|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420011|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
420012|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420013|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
420014|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420015|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
420016|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420017|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
420018|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420019|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
420020|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420021|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
420022|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420023|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
420024|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420025|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
420026|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420027|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
420028|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420029|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
420030|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420031|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
420032|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420033|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
420034|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
420035|NCT00528567|E4|Reported Event|Chemotherapy (>18 Months)|Occurring in participants who received chemotherapy alone, during follow-up period (>18 months) after first dose
420036|NCT00528567|E3|Reported Event|Bevacizumab and Chemotherapy (>18 Months)|Occurring in participants who received bevacizumab and chemotherapy, during follow-up period (>18 months) after first dose
420037|NCT00528567|E2|Reported Event|Chemotherapy (0-18 Months)|Occurring in participants who received chemotherapy alone, during treatment period (0-18 months) after first dose
420038|NCT00528567|E1|Reported Event|Bevacizumab and Chemotherapy (0-18 Months)|Occurring in participants who received bevacizumab and chemotherapy, during treatment period (0-18 months) after first dose
420039|NCT00528606|B3|Baseline|Total|Total of all reporting groups
420040|NCT00528606|B2|Baseline|Placebo|
420041|NCT00528606|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
420042|NCT00528606|P2|Participant Flow|Placebo|
420043|NCT00528606|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
420044|NCT00528606|O2|Outcome|Placebo|
420045|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
420046|NCT00528606|E2|Reported Event|Placebo|
420047|NCT00528606|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
420082|NCT00528866|P1|Participant Flow|Androgen Suppression + RT + Docetaxel|Luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420048|NCT00528645|B1|Baseline|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.
saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks"
420049|NCT00528645|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks"
420050|NCT00528645|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
saracatinib: saracatinib 175mg given orally daily with re-treatment every 3 weeks"
420051|NCT00528645|E1|Reported Event|Treatment (Saracatinib)|saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
420052|NCT00528775|B1|Baseline|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser"
420053|NCT00528775|P1|Participant Flow|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser"
420054|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser"
420055|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser"
420056|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser"
420057|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser"
420058|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser"
420059|NCT00528775|E1|Reported Event|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser"
420060|NCT00528788|B1|Baseline|Pre-post Comparison|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive
doxercalciferol : 2 or 4 mcg"
420061|NCT00528788|P1|Participant Flow|Pre Doxercalciferol/Post Doxercalciferol|"all end stage renal disease patients with secondary hyperparathyroidism who are vitamin D naive
compared pre- and post doxercalciferol."
420062|NCT00528788|O1|Outcome|Pre-post Comparison|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive
doxercalciferol"
420063|NCT00528788|E1|Reported Event|Pre and Post Doxicalciferol|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive
doxercalciferol 2 mcg or 4 mcg three times per week for 1 month"
420064|NCT00528801|B3|Baseline|Total|Total of all reporting groups
420065|NCT00528801|B2|Baseline|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
420066|NCT00528801|B1|Baseline|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
420067|NCT00528801|P2|Participant Flow|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
420068|NCT00528801|P1|Participant Flow|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
420069|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
420070|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
420071|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
420072|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
420073|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
420074|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
420075|NCT00528801|E2|Reported Event|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
420076|NCT00528801|E1|Reported Event|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
420077|NCT00528840|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
420078|NCT00528840|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
420079|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
420080|NCT00528840|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
420081|NCT00528866|B1|Baseline|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420084|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420085|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420086|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420087|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420088|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420089|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420090|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420091|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420092|NCT00528866|E1|Reported Event|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
420093|NCT00528879|B5|Baseline|Total|Total of all reporting groups
420094|NCT00528879|B4|Baseline|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420095|NCT00528879|B3|Baseline|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420096|NCT00528879|B2|Baseline|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420097|NCT00528879|B1|Baseline|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420098|NCT00528879|P4|Participant Flow|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420099|NCT00528879|P3|Participant Flow|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420100|NCT00528879|P2|Participant Flow|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420101|NCT00528879|P1|Participant Flow|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420102|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420103|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420104|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420105|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420106|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420107|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420108|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420109|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420110|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420111|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420112|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420113|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420114|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420115|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420116|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420117|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420118|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420119|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420120|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420121|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420122|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
439618|NCT00577135|O3|Outcome|Low Intensification|
420123|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420124|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420125|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420126|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420127|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420128|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420129|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420130|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420131|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420132|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420133|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420134|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420135|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420136|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420137|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420138|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420139|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420140|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420141|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420142|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420143|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420144|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420145|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420146|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420147|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420148|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420149|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420150|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420151|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420152|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420153|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420154|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420155|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420156|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420157|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420158|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420159|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420160|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
439619|NCT00577135|O2|Outcome|Continuous Infusion|
420161|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420162|NCT00528879|E4|Reported Event|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420163|NCT00528879|E3|Reported Event|Dapagliflozin, 5.0 mg + Metformin|Participants received dapagliflozin, 5.0 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420164|NCT00528879|E2|Reported Event|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420165|NCT00528879|E1|Reported Event|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
420166|NCT00528931|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
420167|NCT00528931|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
420168|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
420169|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
420170|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
420171|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
420172|NCT00528931|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
420173|NCT00528931|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
420174|NCT00528957|B3|Baseline|Total|Total of all reporting groups
420175|NCT00528957|B2|Baseline|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
420176|NCT00528957|B1|Baseline|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
420177|NCT00528957|P2|Participant Flow|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
420178|NCT00528957|P1|Participant Flow|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
420179|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420180|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
420181|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
420182|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420183|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
420184|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
420185|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420186|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
420187|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks).
420188|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420189|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
420190|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
420191|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420192|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
420193|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
420194|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420195|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
420196|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks).
420197|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420198|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
420199|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
420200|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420201|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
420260|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420202|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
420203|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420204|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
420205|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
420206|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases (All TDF group)
420207|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
420208|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
420209|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420210|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
420211|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
420212|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
420213|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
420214|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420215|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
420216|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
420217|NCT00528957|E3|Reported Event|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
420218|NCT00528957|E2|Reported Event|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
420219|NCT00528957|E1|Reported Event|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
420220|NCT00529035|B1|Baseline|Group 1|
420221|NCT00529035|P1|Participant Flow|Ultra-low Dose Interleukin-2|"Daily subcutaneous administration of Interleukin-2 evaluated at three dose levels:
Dose level A: 0.3 x 10^6 IU/m^2/day Dose level B: 1.0 x 10^6 IU/m^2/day Dose level C: 3.0 x 10^6 IU/M^2/day"
420222|NCT00529035|O3|Outcome|Median Treg:Tcon Ratio at Week 12|Immune-cell ratio after a 4 weeks off IL-2 per protocol
420223|NCT00529035|O2|Outcome|Median Treg:Tcon Ratio at Week 8|Immune-cell ratio after 8 weeks of IL-2 therapy
420224|NCT00529035|O1|Outcome|Median Treg:Tcon Ratio at Baseline|Immune-cell ratio before the start of IL-2 therapy
420225|NCT00529035|O3|Outcome|Median Absolute Cell Count at Week 12|Immune-cell counts after a 4 weeks off IL-2 per protocol
420226|NCT00529035|O2|Outcome|Median Absolute Cell Counts at Week 8|Immune-cell counts after 8 weeks of IL-2 therapy
420227|NCT00529035|O1|Outcome|Median Absolute Cell Counts at Baseline|Immune-cell counts before the start of IL-2 therapy
420228|NCT00529035|O1|Outcome|Ultra-low Dose Interleukin-2|
420229|NCT00529035|O1|Outcome|Ultra-low Dose IL-2 MTD|
420230|NCT00529035|E1|Reported Event|Ultra-low Dose Interleukin-2|
420231|NCT00529087|B4|Baseline|Total|Total of all reporting groups
420232|NCT00529087|B3|Baseline|Placebo (Double-blind)|Once daily for weeks 1 through 4
420233|NCT00529087|B2|Baseline|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
420234|NCT00529087|B1|Baseline|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
420235|NCT00529087|P3|Participant Flow|Placebo (Double-blind)|Once daily for weeks 1 through 4
420236|NCT00529087|P2|Participant Flow|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
420237|NCT00529087|P1|Participant Flow|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
420238|NCT00529087|O3|Outcome|Placebo|Once daily
420239|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420240|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420241|NCT00529087|O3|Outcome|Placebo|Once daily
420242|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420243|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420244|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
420245|NCT00529087|O3|Outcome|Placebo|Once daily
420246|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420247|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420248|NCT00529087|O3|Outcome|Placebo|Once daily
420249|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420250|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420251|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
420252|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
420253|NCT00529087|O3|Outcome|Placebo|Once daily
420254|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420255|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420256|NCT00529087|O3|Outcome|Placebo|Once daily
420257|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420258|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420259|NCT00529087|O3|Outcome|Placebo|Once daily
420269|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420270|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420271|NCT00529087|O3|Outcome|Placebo|Once daily
420272|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420273|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420274|NCT00529087|O3|Outcome|Placebo|Once daily
420275|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420276|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420277|NCT00529087|O4|Outcome|Placebo QD (Only QOD Injections)|Placebo group using odd numbered injections corresponding to the active injections in the MOA-728 QOD group. The same placebo patients of 162 was used for each active drug group (QD and QOD).
420278|NCT00529087|O3|Outcome|Placebo|Once daily
420279|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day, Placebo once daily on alternating days
420280|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420281|NCT00529087|O3|Outcome|Placebo|Once daily
420282|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420283|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420284|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
420285|NCT00529087|O3|Outcome|Placebo|Once daily
420286|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420287|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420288|NCT00529087|O2|Outcome|Placebo|Once daily
420289|NCT00529087|O1|Outcome|MOA-728 QD and MOA-728 QOD|MOA-728 12 mg once daily (QD) and MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
420290|NCT00529087|O4|Outcome|Placebo QD|Once daily
420291|NCT00529087|O3|Outcome|Placebo QD (Only QOD Injections)|Placebo group using odd numbered injections corresponding to the active injections in the MOA-728 QOD group. The same placebo patients of 162 was used for each active drug group (QD and QOD).
420292|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), with placebo once daily on alternating days
420293|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
420294|NCT00529087|O2|Outcome|Placebo|Once daily
420295|NCT00529087|O1|Outcome|MOA-728 QD and MOA-728 QOD|MOA-728 QD treatment group (12 mg every day) and MOA-728 QOD treatment group (12 mg once every other day, with placebo once daily on alternating days).
420296|NCT00529087|E4|Reported Event|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) for weeks 5 through 12
420297|NCT00529087|E3|Reported Event|Placebo (Double-blind)|Once daily for weeks 1 through 4
420298|NCT00529087|E2|Reported Event|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
420299|NCT00529087|E1|Reported Event|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
420300|NCT00529100|B4|Baseline|Total|Total of all reporting groups
420301|NCT00529100|B3|Baseline|Pemetrexed/Cisplatin/Radiation Phase 2|Participants were strictly in Phase 2. Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m2 IV.
420302|NCT00529100|B2|Baseline|Pemetrexed/Cisplatin/Radiation Phase 1-Phase 2|Participants were overlap in Phase 1 and Phase 2.
420303|NCT00529100|B1|Baseline|Pemetrexed/Cisplatin/Radiation Phase 1|Participants were strictly in Phase 1. Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
420304|NCT00529100|P2|Participant Flow|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
420305|NCT00529100|P1|Participant Flow|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (every 3 weeks [q3 weeks]) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
420306|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
420307|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
420329|NCT00529126|O2|Outcome|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
439620|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
420308|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
420309|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
420310|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
420311|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
420312|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
420313|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed 500 mg/m^2 as determined by phase 1 trial on Days 1 and 22; concurrent cisplatin 20 mg/m^2 as determined by phase 1 trial with cycles commencing on Days 1 and 22; two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m2.
420314|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on days 1-5 and 22-26 for cohort four. Participants then received two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
420315|NCT00529100|E3|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
420316|NCT00529100|E2|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 1-2|"Cohort 4 data from Phase (Ph) 1 was included in the Ph 2 analysis as Cohort 4 was the established dose from Ph 1.
Ph 1: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment/62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first 3 cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
Ph 2: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment/62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus from Ph 1 trial on Days 1 and 22; concurrent cisplatin from Ph 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2."
420317|NCT00529100|E1|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
420318|NCT00529126|B5|Baseline|Total|Total of all reporting groups
420319|NCT00529126|B4|Baseline|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
420320|NCT00529126|B3|Baseline|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
420321|NCT00529126|B2|Baseline|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
420322|NCT00529126|B1|Baseline|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
420323|NCT00529126|P4|Participant Flow|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
420324|NCT00529126|P3|Participant Flow|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
420325|NCT00529126|P2|Participant Flow|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
420326|NCT00529126|P1|Participant Flow|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
420327|NCT00529126|O4|Outcome|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
420328|NCT00529126|O3|Outcome|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
439621|NCT00577135|O4|Outcome|High Intensification|
420330|NCT00529126|O1|Outcome|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
420331|NCT00529126|E4|Reported Event|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
420332|NCT00529126|E3|Reported Event|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
420333|NCT00529126|E2|Reported Event|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
420334|NCT00529126|E1|Reported Event|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
420335|NCT00529152|B1|Baseline|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
420336|NCT00529152|P1|Participant Flow|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
420337|NCT00529152|O1|Outcome|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
420338|NCT00529152|O1|Outcome|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
420339|NCT00529191|B3|Baseline|Total|Total of all reporting groups
420340|NCT00529191|B2|Baseline|Placebo|Placebo treatment
420341|NCT00529191|B1|Baseline|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
420342|NCT00529191|P2|Participant Flow|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
420343|NCT00529191|P1|Participant Flow|Atorvastatin|Two out of every 3 patients will receive atorvastatin in tablet form. The subject will start on 10mg of atorvastatin daily for four weeks, and then titrate up to 20mg daily. There will be 12 months of treatment followed by 6 months of a washout period.
420344|NCT00529191|O4|Outcome|Placebo YES Islet Cell Preservation|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
420345|NCT00529191|O3|Outcome|Atorvastatin YES Islet Cell Preservation|"Two out of every three patients will receive atorvastatin.
Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
420346|NCT00529191|O2|Outcome|Placebo NO Islet Cell Preservation|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
420347|NCT00529191|O1|Outcome|Atorvastatin NO Islet Cell Preservation|"Two out of every three patients will receive atorvastatin.
Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
420348|NCT00529191|O2|Outcome|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
420349|NCT00529191|O1|Outcome|Atorvastatin|"Two out of every three patients will receive atorvastatin.
Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
420350|NCT00529191|O2|Outcome|Placebo|"Participants in placebo arm who had hypoglycemic episodes requiring treatment
Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period."
420351|NCT00529191|O1|Outcome|Atorvastatin|"Participants in Atorvastatin arm who had hypoglycemic episodes requiring treatment
Two out of every three patients will receive atorvastatin.
Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
420352|NCT00529191|O2|Outcome|Placebo|"Participants in placebo arm who had hypoglycemic episodes requiring treatment
Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period."
420353|NCT00529191|O1|Outcome|Atorvastatin|"Participants in Atorvastatin arm who had hypoglycemic episodes requiring treatment
Two out of every three patients will receive atorvastatin.
Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
420354|NCT00529191|O2|Outcome|Placebo|"One out of three subjects will receive a placebo.
Placebo: One out of three subjects will receive a placebo."
420355|NCT00529191|O1|Outcome|Atorvastatin|"Two out of every three patients will receive atorvastatin.
Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
420356|NCT00529191|O2|Outcome|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
420357|NCT00529191|O1|Outcome|Atorvastatin|"Two out of every three patients will receive atorvastatin.
Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
420358|NCT00529191|O2|Outcome|Placebo|Placebo treatment
420359|NCT00529191|O1|Outcome|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
420360|NCT00529191|O2|Outcome|Placebo|Placebo treatment
420361|NCT00529191|O1|Outcome|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
420362|NCT00529191|E2|Reported Event|Placebo|Placebo treatment
420363|NCT00529191|E1|Reported Event|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
420364|NCT00529204|B1|Baseline|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24
exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
420365|NCT00529204|P1|Participant Flow|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24
exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
420408|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420366|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24
exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
420367|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24
exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
420368|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24
exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
420369|NCT00529204|E1|Reported Event|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24
exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
420370|NCT00529217|B1|Baseline|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
420371|NCT00529217|P1|Participant Flow|Open-Label, rTMS, Active Coil|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
420372|NCT00529217|O1|Outcome|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
420373|NCT00529217|O1|Outcome|Open-Label, rTMS, Active Coil|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
420374|NCT00529217|E1|Reported Event|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
420375|NCT00529243|B1|Baseline|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
420376|NCT00529243|P1|Participant Flow|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
420377|NCT00529243|O1|Outcome|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
420378|NCT00529243|O1|Outcome|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
420379|NCT00529243|E1|Reported Event|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
420380|NCT00529282|B3|Baseline|Total|Total of all reporting groups
420381|NCT00529282|B2|Baseline|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
420382|NCT00529282|B1|Baseline|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
420383|NCT00529282|P2|Participant Flow|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
420384|NCT00529282|P1|Participant Flow|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
420385|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
420386|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
420387|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
420388|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
420389|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
420390|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
420391|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
420392|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
420393|NCT00529282|E2|Reported Event|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
420394|NCT00529282|E1|Reported Event|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
420395|NCT00529308|B3|Baseline|Total|Total of all reporting groups
420396|NCT00529308|B2|Baseline|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420397|NCT00529308|B1|Baseline|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420398|NCT00529308|P2|Participant Flow|Sham|
420399|NCT00529308|P1|Participant Flow|Active rTMS|
420400|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420401|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420402|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420403|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420404|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420405|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420406|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420407|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420542|NCT00529529|B4|Baseline|Total|Total of all reporting groups
420409|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420410|NCT00529308|E2|Reported Event|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420411|NCT00529308|E1|Reported Event|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
420412|NCT00529399|B4|Baseline|Total|Total of all reporting groups
420413|NCT00529399|B3|Baseline|Alum Alone|"3 injections of Aluminum hydroxide alone
Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
420414|NCT00529399|B2|Baseline|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
420415|NCT00529399|B1|Baseline|GAD-alum|"3 injections of GAD-Alum vaccine
GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
420416|NCT00529399|P3|Participant Flow|Alum Alone|"3 injections of Aluminum hydroxide alone
Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
420417|NCT00529399|P2|Participant Flow|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
420418|NCT00529399|P1|Participant Flow|GAD-alum|"3 injections of Glutamic Acid Decarboxylase (GAD)-Alum vaccine
GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
420419|NCT00529399|O3|Outcome|Alum Alone|"3 injections of Aluminum hydroxide alone
Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
420420|NCT00529399|O2|Outcome|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
420421|NCT00529399|O1|Outcome|GAD-alum|"3 injections of GAD-Alum vaccine
GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
420422|NCT00529399|E3|Reported Event|Alum Alone|"3 injections of Aluminum hydroxide alone
Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
420423|NCT00529399|E2|Reported Event|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
420424|NCT00529399|E1|Reported Event|GAD-alum|"3 injections of GAD-Alum vaccine
GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
420425|NCT00529451|B5|Baseline|Total|Total of all reporting groups
420426|NCT00529451|B4|Baseline|Ramipril 5 mg|Ramipril 5 mg once daily
420427|NCT00529451|B3|Baseline|Aliskiren 75 mg|Aliskiren 75 mg once daily
420428|NCT00529451|B2|Baseline|Aliskiren 150 mg|Aliskiren 150 mg once daily
420429|NCT00529451|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg once daily
420430|NCT00529451|P4|Participant Flow|Ramipril 5 mg|Ramipril 5 mg once daily
420431|NCT00529451|P3|Participant Flow|Aliskiren 75 mg|Aliskiren 75 mg once daily
420432|NCT00529451|P2|Participant Flow|Aliskiren 150 mg|Aliskiren 150 mg once daily
420433|NCT00529451|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg once daily
420434|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
420435|NCT00529451|O1|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
420436|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
420437|NCT00529451|O1|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
420438|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
420439|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
420440|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
420441|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
420442|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
420443|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
420444|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
420445|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
420446|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
420447|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
420448|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
420449|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
420450|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
420451|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
420452|NCT00529451|E4|Reported Event|Ramipril 5 mg|Ramipril 5 mg once daily
420453|NCT00529451|E3|Reported Event|Aliskiren 75 mg|Aliskiren 75 mg once daily
420454|NCT00529451|E2|Reported Event|Aliskiren 150 mg|Aliskiren 150 mg once daily
420455|NCT00529451|E1|Reported Event|Aliskiren 300 mg|Aliskiren 300 mg once daily
420456|NCT00529464|B4|Baseline|Total|Total of all reporting groups
420641|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420457|NCT00529464|B3|Baseline|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
420458|NCT00529464|B2|Baseline|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
420459|NCT00529464|B1|Baseline|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
420460|NCT00529464|P3|Participant Flow|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
420461|NCT00529464|P2|Participant Flow|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
420462|NCT00529464|P1|Participant Flow|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
420463|NCT00529464|O3|Outcome|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
420464|NCT00529464|O2|Outcome|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
420465|NCT00529464|O1|Outcome|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
420466|NCT00529464|E3|Reported Event|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
420467|NCT00529464|E2|Reported Event|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
420468|NCT00529464|E1|Reported Event|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
420469|NCT00529516|B4|Baseline|Total|Total of all reporting groups
420470|NCT00529516|B3|Baseline|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420471|NCT00529516|B2|Baseline|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420472|NCT00529516|B1|Baseline|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420473|NCT00529516|P3|Participant Flow|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420474|NCT00529516|P2|Participant Flow|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420475|NCT00529516|P1|Participant Flow|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420476|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420477|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420478|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420479|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420480|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420481|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420482|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420483|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420484|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420485|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420486|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420487|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420488|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420489|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420490|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420491|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420492|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420493|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420494|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420495|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420496|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420497|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420498|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420499|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420500|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420501|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420502|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420503|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420504|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420505|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420506|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420507|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420508|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420509|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420510|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420511|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420512|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420513|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420514|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420515|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420516|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420517|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420518|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420519|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420520|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420521|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420522|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420523|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420524|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420525|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420526|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420527|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420528|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420529|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420530|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420531|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420532|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420533|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420534|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420535|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420536|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420537|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420538|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420539|NCT00529516|E3|Reported Event|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420540|NCT00529516|E2|Reported Event|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
420541|NCT00529516|E1|Reported Event|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
420543|NCT00529529|B3|Baseline|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420544|NCT00529529|B2|Baseline|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420545|NCT00529529|B1|Baseline|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420546|NCT00529529|P3|Participant Flow|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420547|NCT00529529|P2|Participant Flow|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420548|NCT00529529|P1|Participant Flow|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420549|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420550|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420551|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420552|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420553|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420554|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420555|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420642|NCT00529542|O2|Outcome|Placebo|Placebo qd
420556|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420557|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420558|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420559|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420560|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420561|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420562|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420563|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420564|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420565|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420566|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420567|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420568|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420643|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420569|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420570|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420571|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420572|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420573|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420574|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420575|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420576|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420577|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420578|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420579|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420580|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420581|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420644|NCT00529542|E2|Reported Event|Placebo|Placebo qd
420582|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420583|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420584|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420585|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420586|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420587|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420588|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420589|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420590|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420591|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420592|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420593|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420594|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420645|NCT00529542|E1|Reported Event|Atorvastatin|Atorvastatin, 40 mg qd
420595|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420596|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420597|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420598|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420599|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420600|NCT00529529|E3|Reported Event|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420601|NCT00529529|E2|Reported Event|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420602|NCT00529529|E1|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
420603|NCT00529542|B3|Baseline|Total|Total of all reporting groups
420604|NCT00529542|B2|Baseline|Placebo|Placebo qd
420605|NCT00529542|B1|Baseline|Atorvastatin|Atorvastatin, 40 mg qd
420606|NCT00529542|P2|Participant Flow|Placebo|Placebo qd
420607|NCT00529542|P1|Participant Flow|Atorvastatin|Atorvastatin, 40 mg qd
420608|NCT00529542|O2|Outcome|Placebo|Placebo qd
420609|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420610|NCT00529542|O2|Outcome|Placebo|Placebo qd
420611|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420612|NCT00529542|O2|Outcome|Placebo|Placebo qd
420613|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420614|NCT00529542|O2|Outcome|Placebo|Placebo qd
420615|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420616|NCT00529542|O2|Outcome|Placebo|Placebo qd
420617|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420618|NCT00529542|O2|Outcome|Placebo|Placebo qd
420619|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420620|NCT00529542|O2|Outcome|Placebo|Placebo qd
420621|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420622|NCT00529542|O2|Outcome|Placebo|Placebo qd
420623|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420624|NCT00529542|O2|Outcome|Placebo|Placebo qd
420625|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420626|NCT00529542|O2|Outcome|Placebo|Placebo qd
420627|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420628|NCT00529542|O2|Outcome|Placebo|Placebo qd
420629|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420630|NCT00529542|O2|Outcome|Placebo|Placebo qd
420631|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420632|NCT00529542|O2|Outcome|Placebo|Placebo qd
420633|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420634|NCT00529542|O2|Outcome|Placebo|Placebo qd
420635|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420636|NCT00529542|O2|Outcome|Placebo|Placebo qd
420637|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420638|NCT00529542|O2|Outcome|Placebo|Placebo qd
420639|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
420640|NCT00529542|O2|Outcome|Placebo|Placebo qd
420647|NCT00529555|B3|Baseline|Scaling and Root Planing + Vehicle|"Placebo
Scaling and root planing : scaling and root planing"
420648|NCT00529555|B2|Baseline|Scaling & Root Planing + Periocline Gel|"Minocycline HCL 2.1%
minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
420649|NCT00529555|B1|Baseline|Scaling and Root Planing + SHAM TX|"sham treatment
Scaling and root planing : scaling and root planing"
420650|NCT00529555|P3|Participant Flow|Scaling and Root Planing + Vehicle|Gel WITHOUT 2.1% Minocycline HCl + Scaling and root planing
420651|NCT00529555|P2|Participant Flow|Scaling & Root Planing + Periocline Gel|"Gel WITH Minocycline HCL 2.1% + Scaling & root planing
minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
420652|NCT00529555|P1|Participant Flow|Scaling and Root Planing + SHAM TX|Empty syringe + Scaling and root planing
420653|NCT00529555|O3|Outcome|Scaling and Root Planing + Vehicle|"Placebo
Scaling and root planing : scaling and root planing"
420654|NCT00529555|O2|Outcome|Scaling and Root Planing + Periocline Gel|"Minocycline HCL 2.1%
minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
420655|NCT00529555|O1|Outcome|Scaling and Root Planing + SHAM TX|"sham treatment
Scaling and root planing : scaling and root planing"
420656|NCT00529555|E3|Reported Event|Scaling and Root Planing + Vehicle|"Placebo
Scaling and root planing : scaling and root planing"
420657|NCT00529555|E2|Reported Event|Scaling & Root Planing + Periocline Gel|"Minocycline HCL 2.1%
minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
420658|NCT00529555|E1|Reported Event|Scaling and Root Planing + SHAM TX|"sham treatment
Scaling and root planing : scaling and root planing"
420659|NCT00529568|B3|Baseline|Total|Total of all reporting groups
420660|NCT00529568|B2|Baseline|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420661|NCT00529568|B1|Baseline|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420662|NCT00529568|P3|Participant Flow|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420663|NCT00529568|P2|Participant Flow|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420664|NCT00529568|P1|Participant Flow|Eltrombopag: Open-label Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the Open-label Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
420665|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420666|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420667|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420668|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420669|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420670|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420728|NCT00529659|P1|Participant Flow|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
420729|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
420671|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420672|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420673|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420674|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420675|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420676|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420677|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420678|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420679|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420680|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420681|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420682|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420683|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420684|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420685|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420686|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420687|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420688|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420730|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
420731|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
420732|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
420689|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420690|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420691|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420692|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420693|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420694|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420695|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420696|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420697|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420698|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420699|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420700|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420701|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420702|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420703|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
420704|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
420733|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
420734|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
420735|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
420736|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
420705|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
420706|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420707|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420708|NCT00529568|E3|Reported Event|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420709|NCT00529568|E2|Reported Event|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
420710|NCT00529568|E1|Reported Event|Eltrombopag: OL Phase|Participants with a platelet count of &lt;75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was &lt;100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained &lt;100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts &gt;=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts &gt;=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
420711|NCT00529633|B3|Baseline|Total|Total of all reporting groups
420712|NCT00529633|B2|Baseline|Placebo|"12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months
Serum C reactive protein level of ≥ 0.8 mg/dl
Serum albumin < 3.8 g/dl (BCG)
Patients will receive Placebo for a period of 24 weeks."
420713|NCT00529633|B1|Baseline|Thalidomid|"12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months
Serum C reactive protein level of ≥ 0.8 mg/dl
Serum albumin < 3.8 g/dl (BCG)
Patients will receive Thalidomide for a period of 24 weeks.100 mg by mouth at night for 4 weeks; then if tolerated, Thalidomid will be increased to 200 mg by mouth at night for 20 weeks; for a total of 24 weeks on Thalidomid"
420714|NCT00529633|P2|Participant Flow|Thalidomide|"End stage renal disease (ESRD) patients on hemodialysis for at least 3 months
Serum C reactive protein level of ≥ 0.8 mg/dl
Serum albumin < 3.8 g/dl (BCG)
Patients will receive Thalidomide for a period of 24 weeks.
Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP
Thalidomide : 100 mg by mouth at night for 4 weeks 200 mg by mouth at night for 20 weeks"
420715|NCT00529633|P1|Participant Flow|Placebo|"This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks.
Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin. Subject must meet capsule count of >85% compliance with regard to medication and/or birth control requirements as outlined in the S.T.E.P.S ® in the first 4 weeks of study program"
420716|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
420717|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
420718|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
420719|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
420720|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
420721|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
420722|NCT00529633|E2|Reported Event|Placebo|
420723|NCT00529633|E1|Reported Event|Thalidomide|
420724|NCT00529659|B3|Baseline|Total|Total of all reporting groups
420725|NCT00529659|B2|Baseline|Placebo|Placebo administered orally twice daily.
420726|NCT00529659|B1|Baseline|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
420727|NCT00529659|P2|Participant Flow|Placebo|Placebo administered orally twice daily.
420738|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
420739|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
420740|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
420741|NCT00529659|E2|Reported Event|Placebo|Placebo administered orally twice daily.
420742|NCT00529659|E1|Reported Event|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
420743|NCT00529763|B4|Baseline|Total|Total of all reporting groups
420744|NCT00529763|B3|Baseline|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420745|NCT00529763|B2|Baseline|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420746|NCT00529763|B1|Baseline|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420747|NCT00529763|P3|Participant Flow|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420748|NCT00529763|P2|Participant Flow|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420749|NCT00529763|P1|Participant Flow|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420750|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
420751|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
420752|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
420753|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
420754|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
420755|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
420756|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
420757|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
420758|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
420759|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
420760|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
420761|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
420762|NCT00529763|O3|Outcome|Blast Phase CML/Ph+ ALL|Participants with MyBP or LyBP CML or Ph+ALL who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID in advanced phase CML or Ph+ ALL. Participants with advanced disease with BID dosing were required to take their dose in the morning and evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
420763|NCT00529763|O2|Outcome|Accelerated CML|Participants with Ph+ AP who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance.Dasatinib was administered orally at a dose of 70 mg BID in advanced phase CML or Ph+ ALL. Participants with advanced disease with BID dosing were required to take their dose in the morning and evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
420764|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with Ph+ CP CML who have received prior treatment with Imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants with chronic phase CML with QD dosing were permitted to take their dose either in the morning or evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
420765|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420809|NCT00538733|O1|Outcome|T-BiRD Therapy (All Patients)|All 26 patients that were enrolled onto the study were assessed for event free survival.
439622|NCT00577135|O3|Outcome|Low Intensification|
422250|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
420766|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420767|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420768|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420769|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420770|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420771|NCT00529763|O3|Outcome|Total|All treated Participants with Advanced Disease CML - Accelerated Phase (AP) and Blast Phase/PH+ ALL
420772|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420773|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420774|NCT00529763|O1|Outcome|CP CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420775|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420776|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420777|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420778|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420779|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420780|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420781|NCT00529763|E3|Reported Event|Chronic Phase|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420810|NCT00538733|O1|Outcome|T-BiRD Therapy (All Patients)|25 of the 26 patients enrolled onto the were assessed for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.
421031|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
420782|NCT00529763|E2|Reported Event|Blast Phase / Ph+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420783|NCT00529763|E1|Reported Event|Accelerated Phase|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
420784|NCT00529789|B1|Baseline|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420785|NCT00529789|P1|Participant Flow|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420786|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420787|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420788|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420789|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420790|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420791|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420792|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420793|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420794|NCT00529789|O5|Outcome|Duloxetine - 120 mg|120 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
420795|NCT00529789|O4|Outcome|Duloxetine Dose - 90 mg|90 milligrams (mg) every day (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
420796|NCT00529789|O3|Outcome|Duloxetine - 60 mg|60 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
420797|NCT00529789|O2|Outcome|Duloxetine Dose - 30 mg|30 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
420798|NCT00529789|O1|Outcome|Duloxetine Dose - 20 mg|20 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up.
420799|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420800|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420801|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420802|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420803|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420804|NCT00529789|E2|Reported Event|Duloxetine - Period IV|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) between Weeks 18 - 30; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420805|NCT00529789|E1|Reported Event|Duloxetine - Period II/III|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 18 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
420806|NCT00538733|B1|Baseline|T-BiRD Therapy (All Patients)|All patients that enrolled on the study and received treatment with T-BiRD are included in this analysis.
420807|NCT00538733|P1|Participant Flow|T-BiRD Therapy (All Patients)|26 patients started the treatment phase. Per protocol, completion of the treatment phase was defined as removal from treatment due to progression, or to pursue an alternative treatment (either a stem cell transplant, or further consolidation chemotherapy in pursuit of a transplant).
420808|NCT00538733|O1|Outcome|T-BiRD Therapy (All Patients)|25 of the 26 patients enrolled onto the were assessed for progression, as one patient expired prior to first response assessment and could not be included in the analysis.
420811|NCT00538733|O1|Outcome|T-BiRD Therapy (All Patients)|26 patients started the treatment phase. Per protocol, completion of the treatment phase was defined as removal from treatment due to progression, or to pursue an alternative treatment (either a stem cell transplant, or further consolidation chemotherapy in pursuit of a transplant). 25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.
420812|NCT00538733|E1|Reported Event|T-BiRD Therapy (All Patients)|All 26 patients that were enrolled onto the study were assessed for adverse events.
420813|NCT00538785|B3|Baseline|Total|Total of all reporting groups
420814|NCT00538785|B2|Baseline|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420815|NCT00538785|B1|Baseline|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420816|NCT00538785|P2|Participant Flow|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420817|NCT00538785|P1|Participant Flow|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420818|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420819|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420820|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420821|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420822|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420823|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420824|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420825|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420826|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420827|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
421032|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
420828|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420829|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420830|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420831|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420832|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420833|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420834|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420835|NCT00538785|E2|Reported Event|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420836|NCT00538785|E1|Reported Event|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
420837|NCT00538824|B1|Baseline|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.
dexamethasone: Cycles 1-4
• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.
After completing 4 cycles:
Patients who demonstrate disease progression at any time will be taken off study.
Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
420838|NCT00538824|P1|Participant Flow|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.
dexamethasone: Cycles 1-4
• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.
After completing 4 cycles:
Patients who demonstrate disease progression at any time will be taken off study.
Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
420839|NCT00538824|O1|Outcome|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.
dexamethasone: Cycles 1-4
• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.
After completing 4 cycles:
Patients who demonstrate disease progression at any time will be taken off study.
Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
420894|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
421033|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
420840|NCT00538824|E1|Reported Event|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.
dexamethasone: Cycles 1-4
• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.
After completing 4 cycles:
Patients who demonstrate disease progression at any time will be taken off study.
Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
420841|NCT00538850|B1|Baseline|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420842|NCT00538850|P3|Participant Flow|Placebo - Double-blind|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420843|NCT00538850|P2|Participant Flow|Fentanyl Sublingual Spray - Double-blind|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420844|NCT00538850|P1|Participant Flow|Fentanyl Sublingual Spray - Titration|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
420845|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420846|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420847|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420848|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420849|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420850|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420851|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420852|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420853|NCT00538850|E2|Reported Event|Fentanyl Sublingual Spray - Double-blind|Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
420854|NCT00538850|E1|Reported Event|Fentanyl Sublingual Spray - Titration|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
420855|NCT00538863|B1|Baseline|Fentanyl Sublingual Spray|In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
420856|NCT00538863|P1|Participant Flow|Fentanyl Sublingual Spray|In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
420895|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
420896|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420857|NCT00538863|O2|Outcome|Fentanyl Sublingual Spray Maintenance|Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
420858|NCT00538863|O1|Outcome|Fentanyl Sublingual Spray Titration|Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached.
420859|NCT00538863|E2|Reported Event|Fentanyl Sublingual Spray Maintenance|Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
420860|NCT00538863|E1|Reported Event|Fentanyl Sublingual Spray Titration|Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached.
420861|NCT00538902|B4|Baseline|Total|Total of all reporting groups
420862|NCT00538902|B3|Baseline|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420863|NCT00538902|B2|Baseline|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
420864|NCT00538902|B1|Baseline|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420865|NCT00538902|P3|Participant Flow|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
420866|NCT00538902|P2|Participant Flow|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 24 weeks.
420867|NCT00538902|P1|Participant Flow|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
420868|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
420869|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
420870|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420871|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
420872|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420873|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
420874|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420875|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
420876|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420877|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
420878|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
420879|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
420880|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420881|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
420882|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420883|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
420884|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
420885|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420886|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
420887|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420888|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
420889|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
420890|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
420891|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420892|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
420893|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
420897|NCT00538902|E4|Reported Event|Any Adalimumab|Any adalimumab exposure during the entire study, whether from Double-Blind or Open-Label treatment.
420898|NCT00538902|E3|Reported Event|DB Phase - Adalimumab 80 mg EOW|Adalimumab 80 mg administered subcutaneously every other week during Double-Blind treatment.
420899|NCT00538902|E2|Reported Event|DB Phase - Adalimumab 40 mg EOW|Adalimumab 40 mg administered subcutaneously every other week during Double-Blind treatment.
420900|NCT00538902|E1|Reported Event|DB Phase - Placebo EOW|Placebo administered subcutaneously every other week during Double-Blind treatment.
420901|NCT00538915|B1|Baseline|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
420902|NCT00538915|P1|Participant Flow|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
420903|NCT00538915|O1|Outcome|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg administered intravenously every 3 or 4 weeks for approximately 1 year.
420904|NCT00538915|E1|Reported Event|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
420905|NCT00538980|B1|Baseline|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
420906|NCT00538980|P1|Participant Flow|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
420907|NCT00538980|O1|Outcome|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
420908|NCT00538980|O1|Outcome|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
420909|NCT00538980|O1|Outcome|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
420910|NCT00538980|O1|Outcome|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
420998|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
420911|NCT00538980|O1|Outcome|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
420912|NCT00538980|E1|Reported Event|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
420913|NCT00539006|B5|Baseline|Total|Total of all reporting groups
420914|NCT00539006|B4|Baseline|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
420915|NCT00539006|B3|Baseline|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
420916|NCT00539006|B2|Baseline|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
420917|NCT00539006|B1|Baseline|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
420918|NCT00539006|P4|Participant Flow|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
420919|NCT00539006|P3|Participant Flow|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
420920|NCT00539006|P2|Participant Flow|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
420921|NCT00539006|P1|Participant Flow|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
420922|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
420923|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
420924|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
420925|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
420926|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
420927|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
420928|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
420929|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
420930|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
420931|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
420932|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
420933|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
420934|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
420935|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS)110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
420936|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
420937|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
420938|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
420939|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
420940|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
420941|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
420942|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
420943|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
420944|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
420945|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
420946|NCT00539006|E4|Reported Event|Placebo - FP|Subjects who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
420947|NCT00539006|E3|Reported Event|Placebo - FF|Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
420948|NCT00539006|E2|Reported Event|Fluticason Propionate Nasal Spray|Subjects who receive Fluticasone Propionate Nasal Spray.
420949|NCT00539006|E1|Reported Event|Fluticasone Furoate Nasal Spray|Subjects who received Fluticasone Furoate.
420950|NCT00539513|B3|Baseline|Total|Total of all reporting groups
420951|NCT00539513|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
420952|NCT00539513|B1|Baseline|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
420953|NCT00539513|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
420954|NCT00539513|P1|Participant Flow|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
420955|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
420956|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
420957|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
420958|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
420959|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
420960|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
439623|NCT00577135|O2|Outcome|Continuous Infusion|
420961|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
420962|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
420963|NCT00539513|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
420964|NCT00539513|E1|Reported Event|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
420965|NCT00539526|B4|Baseline|Total|Total of all reporting groups
420966|NCT00539526|B3|Baseline|Latanoprost 0.005%|latanoprost 0.005%
420967|NCT00539526|B2|Baseline|Travoprost 0.004%|travoprost 0.004%
420968|NCT00539526|B1|Baseline|Bimatoprost 0.03%|bimatoprost 0.03%
420969|NCT00539526|P3|Participant Flow|Latanoprost 0.005%|latanoprost 0.005%
420970|NCT00539526|P2|Participant Flow|Travoprost 0.004%|travoprost 0.004%
420971|NCT00539526|P1|Participant Flow|Bimatoprost 0.03%|bimatoprost 0.03%
420972|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
420973|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
420974|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
420975|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
420976|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
420977|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
420978|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
420979|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
420980|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
420981|NCT00539526|E3|Reported Event|Latanoprost 0.005%|latanoprost 0.005%
420982|NCT00539526|E2|Reported Event|Travoprost 0.004%|travoprost 0.004%
420983|NCT00539526|E1|Reported Event|Bimatoprost 0.03%|bimatoprost 0.03%
420984|NCT00539539|B3|Baseline|Total|Total of all reporting groups
420985|NCT00539539|B2|Baseline|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
420986|NCT00539539|B1|Baseline|Feedback On|Automated real-time feedback on CPR Process activated
420987|NCT00539539|P2|Participant Flow|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
420988|NCT00539539|P1|Participant Flow|Feedback On|Automated real-time feedback on CPR Process activated
420989|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
420990|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
420991|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
420992|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
420993|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
420994|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
420995|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
420996|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
420997|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
420999|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
421000|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
421001|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
421002|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
421003|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
421004|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
421005|NCT00539539|E2|Reported Event|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
421006|NCT00539539|E1|Reported Event|Feedback On|Automated real-time feedback on CPR Process activated
421007|NCT00539591|B4|Baseline|Total|Total of all reporting groups
421008|NCT00539591|B3|Baseline|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease
Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
421009|NCT00539591|B2|Baseline|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease
Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
421010|NCT00539591|B1|Baseline|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB
Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
421011|NCT00539591|P3|Participant Flow|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease
Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
421012|NCT00539591|P2|Participant Flow|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease
Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
421013|NCT00539591|P1|Participant Flow|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB
Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
421014|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421015|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421016|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
421017|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
421018|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
421019|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421020|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421021|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
421022|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
421023|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
421024|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421025|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421026|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
421027|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
421028|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
421029|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421030|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421034|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
421035|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421036|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421037|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
421038|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
421039|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
421040|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
421041|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
421042|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
421043|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421044|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421045|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
421046|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
421047|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
421048|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
421049|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
421050|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
421051|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421052|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421053|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
421054|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
421055|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
421056|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
421057|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
421058|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
421059|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421060|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421061|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
421062|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
421063|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
421064|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
421065|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
421066|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
421067|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421068|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421069|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
421070|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
421071|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
421072|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
421073|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
421074|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
421075|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
421076|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421077|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421078|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
421079|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
421080|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
421081|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
421082|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
421083|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
421084|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
421085|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421086|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421087|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
421088|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
421089|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
421090|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
421091|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
421092|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
421093|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
421094|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
421095|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
421096|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
421097|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
421098|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
421099|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
421100|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
421101|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
421102|NCT00539591|O1|Outcome|Interferon ɑ-2b|Participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
421103|NCT00539591|O1|Outcome|Interferon ɑ-2b|Participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
421104|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
421105|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
421106|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
421107|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
421108|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
421109|NCT00539591|O2|Outcome|Week 28 - Steady State|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed.
421110|NCT00539591|O1|Outcome|Week 5 - First Dose|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
421111|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
421112|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB
Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
421113|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB
Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
421114|NCT00539591|O2|Outcome|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease
Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
421115|NCT00539591|O1|Outcome|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease
Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
421116|NCT00539591|O1|Outcome|Stratum B1|"Stratum B: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants, divided into 2 groups based on presence (B1) or absence (B2) of measurable disease
Stratum B1 had presence of measurable disease. Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.
Interventions: Temozolomide, peginterferon ɑ-2b"
421117|NCT00539591|E3|Reported Event|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease
Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
421118|NCT00539591|E2|Reported Event|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease
Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
421119|NCT00539591|E1|Reported Event|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB
Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
421120|NCT00539617|B1|Baseline|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
421121|NCT00539617|P1|Participant Flow|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
421122|NCT00539617|O1|Outcome|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
421123|NCT00539617|O1|Outcome|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
421124|NCT00539617|E1|Reported Event|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
421125|NCT00539695|B1|Baseline|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.
Time will be measured as 'week beginning with first IL-2 injection.'
T cell Induction via IL-2 to reduce GVHD
IL-2: IL2 Administration:
Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
421145|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)"
421146|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total"
421126|NCT00539695|P1|Participant Flow|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.
Time will be measured as 'week beginning with first IL-2 injection.'
T cell Induction via IL-2 to reduce GVHD
IL-2: IL2 Administration:
Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
421127|NCT00539695|O1|Outcome|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.
Time will be measured as 'week beginning with first IL-2 injection.'
T cell Induction via IL-2 to reduce GVHD
IL-2: IL2 Administration:
Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
421128|NCT00539695|E1|Reported Event|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.
Time will be measured as 'week beginning with first IL-2 injection.'
T cell Induction via IL-2 to reduce GVHD
IL-2: IL2 Administration:
Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
421129|NCT00539734|B1|Baseline|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
421130|NCT00539734|P1|Participant Flow|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
421131|NCT00539734|O1|Outcome|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
421132|NCT00539734|O1|Outcome|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
421133|NCT00539734|E1|Reported Event|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
421134|NCT00539864|B3|Baseline|Total|Total of all reporting groups
421135|NCT00539864|B2|Baseline|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)"
421136|NCT00539864|B1|Baseline|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total"
421137|NCT00539864|P2|Participant Flow|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)"
421138|NCT00539864|P1|Participant Flow|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total"
421139|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)"
421140|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total"
421141|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)"
421142|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total"
421143|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)"
421144|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total"
421184|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421147|NCT00539864|E2|Reported Event|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur)"
421148|NCT00539864|E1|Reported Event|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total"
421149|NCT00539942|B3|Baseline|Total|Total of all reporting groups
421150|NCT00539942|B2|Baseline|Fondaparinux (Arixtra)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
421151|NCT00539942|B1|Baseline|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
421152|NCT00539942|P2|Participant Flow|Arixtra (Fondaparinux Sodium)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
421153|NCT00539942|P1|Participant Flow|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
421154|NCT00539942|O2|Outcome|Arixtra (Fondaparinux Sodium)|Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)
421155|NCT00539942|O1|Outcome|Intermittent Compression Devices|Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
421156|NCT00539942|O2|Outcome|Arixtra (Fondaparinux Sodium)|Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)
421157|NCT00539942|O1|Outcome|Intermittent Compression Devices|Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
421158|NCT00539942|E2|Reported Event|Arixtra (Fondaparinux Sodium)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
421159|NCT00539942|E1|Reported Event|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
421160|NCT00539994|B4|Baseline|Total|Total of all reporting groups
421161|NCT00539994|B3|Baseline|Placebo|Placebo 200 mg BID for 5 days
421162|NCT00539994|B2|Baseline|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421163|NCT00539994|B1|Baseline|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
421164|NCT00539994|P3|Participant Flow|Placebo|Placebo 200 mg BID for 5 days
421165|NCT00539994|P2|Participant Flow|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421166|NCT00539994|P1|Participant Flow|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
421167|NCT00539994|O4|Outcome|Total|Total of all groups
421168|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
421169|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421170|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
421171|NCT00539994|O1|Outcome|MRSA|Methicillin Resistant S. aureus.
421172|NCT00539994|O2|Outcome|Positive Pharyngeal Culture for S. Aureus|Subjects who tested positive for S. aureus in the pharyngeal region.
421173|NCT00539994|O1|Outcome|Positive Nasal Culture for S. Aureus|Screened subjects positive for S. aureus
421174|NCT00539994|O4|Outcome|Total|Total of all Groups
421175|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
421176|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421177|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 Days and Placebo 2 days
421178|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
421179|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421180|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
421181|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
421182|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421183|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
421185|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
421186|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421187|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
421188|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
421189|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421190|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
421191|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421192|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
421193|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421194|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
421195|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421196|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
421197|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421198|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
421199|NCT00539994|E3|Reported Event|Placebo|Placebo 200 mg BID for 5 days
421200|NCT00539994|E2|Reported Event|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
421201|NCT00539994|E1|Reported Event|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
421202|NCT00540046|B3|Baseline|Total|Total of all reporting groups
421203|NCT00540046|B2|Baseline|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.
Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
421204|NCT00540046|B1|Baseline|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure
Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
421205|NCT00540046|P2|Participant Flow|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.
Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
421206|NCT00540046|P1|Participant Flow|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure
Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
421207|NCT00540046|O2|Outcome|B/Delayed|"The delayed group had the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.
IUD status was known six months post-abortion."
421208|NCT00540046|O1|Outcome|A/Immediate|"The patients in the immediate arm had the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure.
IUD status was known six months post-abortion and insertion."
421209|NCT00540046|O2|Outcome|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.
Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
421210|NCT00540046|O1|Outcome|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure
Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
421211|NCT00540046|E2|Reported Event|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.
Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
421212|NCT00540046|E1|Reported Event|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure
Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
421213|NCT00540124|B4|Baseline|Total|Total of all reporting groups
421214|NCT00540124|B3|Baseline|Tamsulosin|0.2 mg by mouth once a day
421215|NCT00540124|B2|Baseline|Tadalafil|5 mg by mouth once a day
421216|NCT00540124|B1|Baseline|Placebo|by mouth once a day
421217|NCT00540124|P3|Participant Flow|Tamsulosin|0.2 mg by mouth once a day
421218|NCT00540124|P2|Participant Flow|Tadalafil|5 mg by mouth once a day
421219|NCT00540124|P1|Participant Flow|Placebo|by mouth once a day
421220|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
421221|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
421222|NCT00540124|O1|Outcome|Placebo|by mouth once a day
421223|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
421224|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
421225|NCT00540124|O1|Outcome|Placebo|by mouth once a day
421226|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
421227|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
421228|NCT00540124|O1|Outcome|Placebo|by mouth once a day
421229|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
421230|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
421231|NCT00540124|O1|Outcome|Placebo|by mouth once a day
421232|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
421233|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
421234|NCT00540124|O1|Outcome|Placebo|by mouth once a day
421235|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
421236|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
421237|NCT00540124|O1|Outcome|Placebo|by mouth once a day
421238|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
421239|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
421240|NCT00540124|O1|Outcome|Placebo|by mouth once a day
421241|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
421242|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
421263|NCT00540228|B5|Baseline|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421264|NCT00540228|B4|Baseline|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421265|NCT00540228|B3|Baseline|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421266|NCT00540228|B2|Baseline|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421267|NCT00540228|B1|Baseline|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421268|NCT00540228|P5|Participant Flow|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421269|NCT00540228|P4|Participant Flow|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421270|NCT00540228|P3|Participant Flow|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421271|NCT00540228|P2|Participant Flow|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421272|NCT00540228|P1|Participant Flow|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421273|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421274|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421275|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421276|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421277|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421278|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421279|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421280|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421281|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421282|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421283|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421284|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421285|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421286|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421287|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421288|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421289|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421427|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
439624|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
421290|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421291|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421292|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421293|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421294|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421295|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421296|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421297|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421298|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421299|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421300|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421301|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421302|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421303|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421304|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421305|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421306|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421307|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421308|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421309|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421310|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421311|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421312|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421313|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421314|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421315|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421316|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421428|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421317|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421318|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421319|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421320|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421321|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421322|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421323|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421324|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421325|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421326|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421327|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421328|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421329|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421330|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421331|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421332|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421333|NCT00540228|E5|Reported Event|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421334|NCT00540228|E4|Reported Event|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421335|NCT00540228|E3|Reported Event|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421336|NCT00540228|E2|Reported Event|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421337|NCT00540228|E1|Reported Event|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
421338|NCT00540293|B1|Baseline|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
421339|NCT00540293|P1|Participant Flow|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
421340|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
421341|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
421342|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
421343|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
421344|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
421345|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
421543|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
422249|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
421346|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
421347|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
421348|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
421349|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
421350|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
421351|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
421352|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
421353|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
421354|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
421355|NCT00540293|O1|Outcome|Total|N=425 (Total: sum of all risk groups)
421356|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
421357|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
421358|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
421359|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
421360|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
421361|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
421362|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
421363|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
421364|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
421365|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
421366|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
421367|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
421368|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
421369|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
421370|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
421371|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
421372|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
421373|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
421374|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
421375|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
421376|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
421377|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
421378|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
421379|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
421380|NCT00540293|E1|Reported Event|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
421381|NCT00540423|B3|Baseline|Total|Total of all reporting groups
421382|NCT00540423|B2|Baseline|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421383|NCT00540423|B1|Baseline|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421426|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
439625|NCT00577135|O4|Outcome|High Intensification|
421384|NCT00540423|P3|Participant Flow|SB-497115-GR, Open-label|All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count.
421385|NCT00540423|P2|Participant Flow|SB-497115-GR, Double-blind|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7.
421386|NCT00540423|P1|Participant Flow|Placebo|Placebo 12.5 milligrams (mg) for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7
421387|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB497511-GR on the PK sampling day
421388|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
421389|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
421390|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497511-GR on the PK sampling day
421391|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB497511-GR on the PK sampling day
421392|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
421393|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497511-GR on the PK sampling day
421394|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
421395|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
421396|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
421397|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
421398|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
421399|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
421400|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
421401|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
421402|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
421403|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
421404|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
421405|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
421406|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
421407|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
421408|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
421409|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421410|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
421411|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
421412|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
421413|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
421414|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
421415|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
421416|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
421417|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421418|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421419|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421420|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421421|NCT00540423|O2|Outcome|SG-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421422|NCT00540423|O1|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421423|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421424|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421425|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421843|NCT00541242|E2|Reported Event|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
421429|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421430|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421431|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421432|NCT00540423|E3|Reported Event|SB-497115-GR Long-Term Phase|All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received up to 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count
421433|NCT00540423|E2|Reported Event|SB-497115-GR Short-Term (Double-Blind) Phase|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421434|NCT00540423|E1|Reported Event|Placebo Short-Term (Double-Blind) Phase|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
421435|NCT00540436|B1|Baseline|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
421436|NCT00540436|P1|Participant Flow|GSK1325760A|First Treatment Period: GSK1325760A 5 mg once a day. Second Treatment Period: GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
421437|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
421438|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
421439|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
421440|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
421441|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
421442|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
421443|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
421444|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
421445|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
421446|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
421447|NCT00540436|E1|Reported Event|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
421448|NCT00540449|B3|Baseline|Total|Total of all reporting groups
421449|NCT00540449|B2|Baseline|Efavirenz|600 mg once daily for 96 weeks.
421450|NCT00540449|B1|Baseline|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421451|NCT00540449|P2|Participant Flow|Efavirenz|600 mg once daily for 96 weeks.
421452|NCT00540449|P1|Participant Flow|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421453|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
421454|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421455|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
421456|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421457|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
421458|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421459|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
421460|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421461|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
421462|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421463|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
421464|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421465|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
421466|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421467|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
421468|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421469|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
421470|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421471|NCT00540449|E2|Reported Event|Efavirenz|600 mg once daily for 96 weeks.
421472|NCT00540449|E1|Reported Event|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
421473|NCT00540514|B3|Baseline|Total|Total of all reporting groups
421474|NCT00540514|B2|Baseline|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421475|NCT00540514|B1|Baseline|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421476|NCT00540514|P2|Participant Flow|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421477|NCT00540514|P1|Participant Flow|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421478|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421479|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421480|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421481|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421482|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421483|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421484|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421485|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421486|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421487|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421488|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421504|NCT00540514|E2|Reported Event|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
439626|NCT00577135|O3|Outcome|Low Intensification|
421489|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421490|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421491|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421492|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421493|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421494|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421495|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421496|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421497|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421498|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421499|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421500|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421501|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421502|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421503|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421541|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421542|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421505|NCT00540514|E1|Reported Event|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
421506|NCT00540579|B1|Baseline|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
421507|NCT00540579|P1|Participant Flow|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
421508|NCT00540579|O1|Outcome|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
421509|NCT00540579|O1|Outcome|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
421510|NCT00540579|E1|Reported Event|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
421511|NCT00540592|B11|Baseline|Total|Total of all reporting groups
421512|NCT00540592|B10|Baseline|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421513|NCT00540592|B9|Baseline|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421514|NCT00540592|B8|Baseline|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421515|NCT00540592|B7|Baseline|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421516|NCT00540592|B6|Baseline|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421517|NCT00540592|B5|Baseline|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421518|NCT00540592|B4|Baseline|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421519|NCT00540592|B3|Baseline|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421520|NCT00540592|B2|Baseline|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421521|NCT00540592|B1|Baseline|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421522|NCT00540592|P10|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421523|NCT00540592|P9|Participant Flow|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421524|NCT00540592|P8|Participant Flow|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421525|NCT00540592|P7|Participant Flow|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421526|NCT00540592|P6|Participant Flow|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421527|NCT00540592|P5|Participant Flow|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421528|NCT00540592|P4|Participant Flow|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421529|NCT00540592|P3|Participant Flow|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421530|NCT00540592|P2|Participant Flow|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421531|NCT00540592|P1|Participant Flow|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421532|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421533|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421534|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421535|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421536|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421537|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421538|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421539|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421540|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421544|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421545|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421546|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421547|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421548|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421549|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421550|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421551|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421552|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421553|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421554|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421555|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421556|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421557|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421558|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421559|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421560|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421561|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421562|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421563|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421564|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421565|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421566|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421567|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421568|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421569|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421570|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421571|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421572|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421573|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421574|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421575|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421576|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421577|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421578|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421579|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421580|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421581|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421582|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
439627|NCT00577135|O2|Outcome|Continuous Infusion|
421583|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421584|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421585|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421586|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421587|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421588|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421589|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421590|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421591|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421592|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421593|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421594|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421595|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421596|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421597|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421598|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421599|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421600|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421601|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421602|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421603|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421604|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421605|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421606|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421607|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421608|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421609|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421610|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421611|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421612|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421613|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421614|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421615|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421616|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421617|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421618|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421619|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421620|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421621|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
439628|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
421622|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421623|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421624|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421625|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421626|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421627|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421628|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421629|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421630|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421631|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421632|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421633|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421634|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421635|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421636|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421637|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421638|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421639|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421640|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421641|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421642|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421643|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421644|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421645|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421646|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421647|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421648|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421649|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421650|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421651|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421652|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421653|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421654|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421655|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421656|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421657|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421658|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421659|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421660|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421844|NCT00541242|E1|Reported Event|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
421661|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421662|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421663|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421664|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421665|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421666|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421667|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421668|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421669|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421670|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421671|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421672|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421673|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421674|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421675|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421676|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421677|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421678|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421679|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421680|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421681|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421682|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421683|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421684|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421685|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421686|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421687|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421688|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421689|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421690|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421691|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421692|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421693|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421694|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421695|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421696|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421697|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421698|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421699|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421845|NCT00541307|B1|Baseline|Enrolled Subjects|The total number of enrolled subjects.
421700|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421701|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421702|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421703|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421704|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421705|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421706|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421707|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421708|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421709|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421710|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421711|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421712|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421713|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421714|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421715|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421716|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421717|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421718|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421719|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421720|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421721|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421722|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421723|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421724|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421725|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421726|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421727|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421728|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421729|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421730|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421731|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421732|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421733|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421734|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421735|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421736|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421737|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421738|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421846|NCT00541307|P1|Participant Flow|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
421739|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421740|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421741|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421742|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421743|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421744|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421745|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421746|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421747|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421748|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421749|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421750|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421751|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421752|NCT00540592|E10|Reported Event|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
421753|NCT00540592|E9|Reported Event|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
421754|NCT00540592|E8|Reported Event|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
421755|NCT00540592|E7|Reported Event|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
421756|NCT00540592|E6|Reported Event|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
421757|NCT00540592|E5|Reported Event|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
421758|NCT00540592|E4|Reported Event|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
421759|NCT00540592|E3|Reported Event|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
421760|NCT00540592|E2|Reported Event|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
421761|NCT00540592|E1|Reported Event|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
421762|NCT00540644|B3|Baseline|Total|Total of all reporting groups
421763|NCT00540644|B2|Baseline|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421764|NCT00540644|B1|Baseline|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421765|NCT00540644|P2|Participant Flow|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421766|NCT00540644|P1|Participant Flow|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421767|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421768|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421769|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421770|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421771|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421847|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
421772|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421773|NCT00540644|E2|Reported Event|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421774|NCT00540644|E1|Reported Event|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
421775|NCT00540722|B1|Baseline|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.
R-(-)-gossypol acetic acid: Given PO
laboratory biomarker analysis: Correlative studies"
421776|NCT00540722|P1|Participant Flow|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.
R-(-)-gossypol acetic acid: Given PO
laboratory biomarker analysis: Correlative studies"
421777|NCT00540722|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.
R-(-)-gossypol acetic acid: Given PO
laboratory biomarker analysis: Correlative studies"
421778|NCT00540722|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.
R-(-)-gossypol acetic acid: Given PO
laboratory biomarker analysis: Correlative studies"
421779|NCT00540722|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.
R-(-)-gossypol acetic acid: Given PO
laboratory biomarker analysis: Correlative studies"
421780|NCT00540722|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.
R-(-)-gossypol acetic acid: Given PO
laboratory biomarker analysis: Correlative studies"
421781|NCT00540722|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.
R-(-)-gossypol acetic acid: Given PO
laboratory biomarker analysis: Correlative studies"
421782|NCT00540722|E1|Reported Event|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.
R-(-)-gossypol acetic acid: Given PO
laboratory biomarker analysis: Correlative studies"
421783|NCT00540969|B3|Baseline|Total|Total of all reporting groups
421848|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
421784|NCT00540969|B2|Baseline|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.
radiation therapy: Patients undergo radiotherapy for 1 week"
421785|NCT00540969|B1|Baseline|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.
cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
421786|NCT00540969|P2|Participant Flow|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.
radiation therapy: Patients undergo radiotherapy for 1 week"
421787|NCT00540969|P1|Participant Flow|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.
cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
421788|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.
radiation therapy: Patients undergo radiotherapy for 1 week"
421789|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.
cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
421790|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.
radiation therapy: Patients undergo radiotherapy for 1 week"
421791|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.
cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
421792|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.
radiation therapy: Patients undergo radiotherapy for 1 week"
421793|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.
cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
421794|NCT00540969|E2|Reported Event|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.
radiation therapy: Patients undergo radiotherapy for 1 week"
421795|NCT00540969|E1|Reported Event|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.
cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
421796|NCT00541034|B1|Baseline|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
421797|NCT00541034|P1|Participant Flow|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
421798|NCT00541034|O1|Outcome|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
421799|NCT00541034|E1|Reported Event|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
421800|NCT00541099|B1|Baseline|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
421801|NCT00541099|P1|Participant Flow|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
421802|NCT00541099|O1|Outcome|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
421803|NCT00541099|E1|Reported Event|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
421804|NCT00541190|B3|Baseline|Total|Total of all reporting groups
421805|NCT00541190|B2|Baseline|Healthy Controls|Healthy subjects.
421806|NCT00541190|B1|Baseline|Cystic Fibrosis|Cystic fibrosis patients
421807|NCT00541190|P2|Participant Flow|Healthy Controls|Healthy subjects.
421808|NCT00541190|P1|Participant Flow|Cystic Fibrosis|Cystic fibrosis patients
421809|NCT00541190|O2|Outcome|Healthy Controls|Healthy subjects.
421810|NCT00541190|O1|Outcome|Cystic Fibrosis|Cystic fibrosis patients
421811|NCT00541190|O2|Outcome|Healthy Controls|Healthy subjects without lung disease - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
421812|NCT00541190|O1|Outcome|Cystic Fibrosis|Cystic fibrosis patients - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
421813|NCT00541190|E2|Reported Event|Healthy Controls|Healthy subjects.
421814|NCT00541190|E1|Reported Event|Cystic Fibrosis|Cystic fibrosis patients
421815|NCT00541229|B7|Baseline|Total|Total of all reporting groups
421849|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
421816|NCT00541229|B6|Baseline|200 mg / 100 mg / Placebo|200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
421817|NCT00541229|B5|Baseline|100 mg / Placebo / 200 mg|100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
421818|NCT00541229|B4|Baseline|Placebo / 200 mg / 100 mg|Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
421819|NCT00541229|B3|Baseline|200 mg / Placebo / 100 mg|200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
421820|NCT00541229|B2|Baseline|100 mg / 200 mg / Placebo|100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
421821|NCT00541229|B1|Baseline|Placebo / 100 mg / 200 mg|Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
421822|NCT00541229|P6|Participant Flow|200 mg / 100 mg / Placebo|200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
421823|NCT00541229|P5|Participant Flow|100 mg / Placebo / 200 mg|100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
421824|NCT00541229|P4|Participant Flow|Placebo / 200 mg / 100 mg|Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
421825|NCT00541229|P3|Participant Flow|200 mg / Placebo / 100 mg|200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
421826|NCT00541229|P2|Participant Flow|100 mg / 200 mg / Placebo|100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
421827|NCT00541229|P1|Participant Flow|Placebo / 100 mg / 200 mg|Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
421828|NCT00541229|O3|Outcome|Placebo|Placebo group included the Treatment Period I data from patients randomized to treatment sequence placebo/Sitagliptin 100 mg/Sitagliptin 200 mg and treatment sequence placebo/Sitagliptin 200 mg/Sitagliptin 100 mg.
421829|NCT00541229|O2|Outcome|Sitagliptin 100mg|Sitagliptin 100 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 100 mg/Sitagliptin 200 mg/placebo and treatment sequence Sitagliptin 100 mg/ placebo/ Sitagliptin 200 mg.
421830|NCT00541229|O1|Outcome|Sitagliptin 200mg|Sitagliptin 200 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 200 mg/Sitagliptin 100 mg/placebo and treatment sequence Sitagliptin 200 mg/ placebo/ Sitagliptin 100 mg.
421831|NCT00541229|E3|Reported Event|Placebo|Placebo Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin-matching placebo tablets. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
421832|NCT00541229|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 100 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
421833|NCT00541229|E1|Reported Event|Sitagliptin 200 mg|Sitagliptin 200 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 200 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
421834|NCT00541242|B3|Baseline|Total|Total of all reporting groups
421835|NCT00541242|B2|Baseline|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
421836|NCT00541242|B1|Baseline|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
421837|NCT00541242|P2|Participant Flow|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
421838|NCT00541242|P1|Participant Flow|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
421839|NCT00541242|O2|Outcome|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
421840|NCT00541242|O1|Outcome|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
421841|NCT00541242|O2|Outcome|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
421842|NCT00541242|O1|Outcome|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
421850|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
421851|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
421852|NCT00541307|E1|Reported Event|Gore VIABAHN Endoprosthesis With Heparin Bioactive Surface|Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
421853|NCT00541346|B1|Baseline|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421854|NCT00541346|P1|Participant Flow|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421855|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421856|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421857|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421858|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421859|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421860|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421861|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421862|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421863|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421864|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421865|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421866|NCT00541346|E1|Reported Event|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
421867|NCT00541450|B3|Baseline|Total|Total of all reporting groups
421868|NCT00541450|B2|Baseline|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.
In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
421869|NCT00541450|B1|Baseline|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.
In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
421870|NCT00541450|P2|Participant Flow|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.
In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
421871|NCT00541450|P1|Participant Flow|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.
In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
421872|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
421873|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
421874|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.
In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
421901|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421875|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.
In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
421876|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
421877|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
421878|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
421879|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
421880|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.
In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
421881|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.
In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
421882|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.
In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
421883|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.
In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
421884|NCT00541450|E4|Reported Event|Pioglitazone (Weeks 0-40)|"In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg q.d.
In Phase B (Treatment Week 12 -Week 40), participants were administered 45 mg q.d."
421885|NCT00541450|E3|Reported Event|Sita/Met FDC (Weeks 0-40)|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.
In Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg b.i.d., which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
421886|NCT00541450|E2|Reported Event|Pioglitazone (Weeks 0-12)|In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, all participants were up-titrated to 30 mg q.d. pioglitazone.
421887|NCT00541450|E1|Reported Event|Sitagliptin (Weeks 0-12)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.
421888|NCT00541593|B1|Baseline|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
421889|NCT00541593|P1|Participant Flow|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
421890|NCT00541593|O1|Outcome|NOTES Pancreatic Pseudocystgastrostomy Patients|Pancreatic Pseudocystgastrostomy Patients having NOTES procedure
421891|NCT00541593|E1|Reported Event|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
421892|NCT00541658|B4|Baseline|Total|Total of all reporting groups
421893|NCT00541658|B3|Baseline|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421894|NCT00541658|B2|Baseline|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421895|NCT00541658|B1|Baseline|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421896|NCT00541658|P3|Participant Flow|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421897|NCT00541658|P2|Participant Flow|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421898|NCT00541658|P1|Participant Flow|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421899|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421900|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421902|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421903|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421904|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421905|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421906|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421907|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421908|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421909|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421910|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421911|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421912|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421913|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421914|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421915|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421916|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421917|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421918|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421919|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421920|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421921|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421922|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421923|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421924|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421925|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421926|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421927|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421928|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421929|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421930|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421931|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421932|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421933|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421934|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421935|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421936|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421937|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421938|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421939|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421940|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421941|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421942|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421943|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421944|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421945|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421946|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421947|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421948|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421949|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421950|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421951|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421952|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421953|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421954|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421955|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421956|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421957|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421958|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421959|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421960|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421961|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421962|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421963|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421964|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421965|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421966|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421967|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421968|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421969|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421970|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421971|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421972|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421973|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421974|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421975|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421976|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421977|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421978|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421979|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421980|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421981|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421982|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421983|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421984|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421985|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421986|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421987|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421988|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421989|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421990|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421991|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421992|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421993|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421994|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421995|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421996|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
421997|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
421998|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
421999|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422000|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422001|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422002|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422003|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422004|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422005|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422006|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422007|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422008|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422009|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422010|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422011|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422012|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422013|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422014|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422015|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422016|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422017|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422018|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422019|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422020|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422021|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422022|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422023|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422024|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422025|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422026|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422027|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422028|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422029|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422030|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422031|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422032|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422033|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422034|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422035|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422036|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422037|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422038|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422039|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422040|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422041|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422042|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422043|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422044|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422045|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422046|NCT00541658|O2|Outcome|35 mg DRFB + DRBB|Combined two arms - 35 mg delayed-release following breakfast (DRFB) with 35 mg delayed-relase before breakfast (DRBB)
422047|NCT00541658|O1|Outcome|5 mg IRBB|5 mg immediate-release risedronate tablet daily, at least 30 minutes before breakfast for two years
422048|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422049|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422050|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422051|NCT00541658|E3|Reported Event|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
422052|NCT00541658|E2|Reported Event|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
422053|NCT00541658|E1|Reported Event|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
422054|NCT00541671|B3|Baseline|Total|Total of all reporting groups
422055|NCT00541671|B2|Baseline|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
422056|NCT00541671|B1|Baseline|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
422057|NCT00541671|P2|Participant Flow|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
422058|NCT00541671|P1|Participant Flow|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
422059|NCT00541671|O2|Outcome|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
422060|NCT00541671|O1|Outcome|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
422061|NCT00541671|E2|Reported Event|Promethazine|
422062|NCT00541671|E1|Reported Event|Placebo|
422063|NCT00541775|B4|Baseline|Total|Total of all reporting groups
422064|NCT00541775|B3|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
422065|NCT00541775|B2|Baseline|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
422066|NCT00541775|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
422067|NCT00541775|P3|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
422068|NCT00541775|P2|Participant Flow|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
422069|NCT00541775|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
422070|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
422071|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
422072|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
422116|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information
universal education : receives referral information"
422073|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
422074|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
422075|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
422076|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
422077|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
422078|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
422079|NCT00541775|E3|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
422080|NCT00541775|E2|Reported Event|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
422081|NCT00541775|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
422082|NCT00526799|B3|Baseline|Total|Total of all reporting groups
422083|NCT00526799|B2|Baseline|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
422084|NCT00526799|B1|Baseline|Phase I|"Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:
Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
422085|NCT00526799|P2|Participant Flow|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
422086|NCT00526799|P1|Participant Flow|Phase I|"Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:
Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
422087|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
422088|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
422089|NCT00526799|O1|Outcome|Phase I & II|"Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily during phase II.
During phase I:
Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:
Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
422090|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
422091|NCT00526799|O1|Outcome|Phase I Participants|Phase I Participants evaluable for MTD
422092|NCT00526799|E1|Reported Event|Phase I/Phase II|All Phase I/Phase II participants
422093|NCT00526890|B1|Baseline|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
422094|NCT00526890|P1|Participant Flow|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
422095|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
422096|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
422097|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
422098|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
422099|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
422100|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
422101|NCT00526890|E1|Reported Event|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
422102|NCT00526994|B4|Baseline|Total|Total of all reporting groups
422103|NCT00526994|B3|Baseline|Control|no screen and no referral
422104|NCT00526994|B2|Baseline|Universal Education (All Referred)|"receives referral information
universal education : receives referral information"
422105|NCT00526994|B1|Baseline|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information
screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
422106|NCT00526994|P3|Participant Flow|Control|no screen and no referral
422107|NCT00526994|P2|Participant Flow|Universal Education (All Referred)|"receives referral information
universal education : receives referral information"
422108|NCT00526994|P1|Participant Flow|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information
screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
422109|NCT00526994|O3|Outcome|Control|no screen and no referral
422110|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information
universal education : receives referral information"
422111|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information
screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
422112|NCT00526994|O3|Outcome|Control|no screen and no referral
422113|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information
universal education : receives referral information"
422114|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information
screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
422115|NCT00526994|O3|Outcome|Control|no screen and no referral
422117|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information
screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
422118|NCT00526994|O3|Outcome|Control|no screen and no referral
422119|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information
universal education : receives referral information"
422120|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information
screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
422121|NCT00526994|E3|Reported Event|Control|no screen and no referral
422122|NCT00526994|E2|Reported Event|Universal Education (All Referred)|"receives referral information
universal education : receives referral information"
422123|NCT00526994|E1|Reported Event|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information
screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
422124|NCT00527072|B1|Baseline|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
422125|NCT00527072|P1|Participant Flow|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
422126|NCT00527072|O1|Outcome|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
422127|NCT00527072|O1|Outcome|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
422128|NCT00527072|O1|Outcome|Infliximab|Open-label study, patients received IV infusions of 5 mg/kg infliximab at Weeks 0, 2, 6, 14, and 22
422129|NCT00527072|E1|Reported Event|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
422130|NCT00527098|B3|Baseline|Total|Total of all reporting groups
422131|NCT00527098|B2|Baseline|Standard of Care|Routine Standard of Care Resuscitation Fluid
422132|NCT00527098|B1|Baseline|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
422133|NCT00527098|P2|Participant Flow|Standard of Care|Routine Standard of Care Resuscitation Fluid
422134|NCT00527098|P1|Participant Flow|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
422135|NCT00527098|O1|Outcome|Observational|This is an observational trial.
422136|NCT00527098|E2|Reported Event|Standard of Care|Routine Standard of Care Resuscitation Fluid
422137|NCT00527098|E1|Reported Event|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
422138|NCT00527111|B3|Baseline|Total|Total of all reporting groups
422139|NCT00527111|B2|Baseline|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil
5-fluorouracil
Pelvic irradiation"
422140|NCT00527111|B1|Baseline|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab
Cetuximab
5-fluorouracil
Pelvic irradiation"
422141|NCT00527111|P2|Participant Flow|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil
5-fluorouracil
Pelvic irradiation"
422142|NCT00527111|P1|Participant Flow|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab
Cetuximab
5-fluorouracil
Pelvic irradiation"
422143|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil
5-fluorouracil
Pelvic irradiation"
422144|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab
Cetuximab
5-fluorouracil
Pelvic irradiation"
422145|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil
5-fluorouracil
Pelvic irradiation"
422146|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab
Cetuximab
5-fluorouracil
Pelvic irradiation"
422147|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil
5-fluorouracil
Pelvic irradiation"
422148|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab
Cetuximab
5-fluorouracil
Pelvic irradiation"
422149|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil
5-fluorouracil
Pelvic irradiation"
422150|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab
Cetuximab
5-fluorouracil
Pelvic irradiation"
422151|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil
5-fluorouracil
Pelvic irradiation"
422152|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab
Cetuximab
5-fluorouracil
Pelvic irradiation"
422153|NCT00527111|E2|Reported Event|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil
5-fluorouracil
Pelvic irradiation"
422154|NCT00527111|E1|Reported Event|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab
Cetuximab
5-fluorouracil
Pelvic irradiation"
422155|NCT00527124|B3|Baseline|Total|Total of all reporting groups
422156|NCT00527124|B2|Baseline|Arm II|Patients receive docetaxel and prednisone as in arm I.
422157|NCT00527124|B1|Baseline|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
422158|NCT00527124|P2|Participant Flow|Arm II|Patients receive docetaxel and prednisone as in arm I.
422159|NCT00527124|P1|Participant Flow|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
422160|NCT00527124|O2|Outcome|Arm II|Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
422161|NCT00527124|O1|Outcome|Arm I|Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
422162|NCT00527124|E2|Reported Event|Arm II|Patients receive docetaxel and prednisone as in arm I.
422163|NCT00527124|E1|Reported Event|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
422164|NCT00527319|B4|Baseline|Total|Total of all reporting groups
422165|NCT00527319|B3|Baseline|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
439629|NCT00577135|O4|Outcome|High Intensification|
422166|NCT00527319|B2|Baseline|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
422167|NCT00527319|B1|Baseline|Group A, Control Group|Supportive care only
422168|NCT00527319|P3|Participant Flow|Group C, High Dose VT-122|VT-122 high dose Supportive care
422169|NCT00527319|P2|Participant Flow|Group B, Low Dose VT-122|VT-122 low dose Supportive care
422170|NCT00527319|P1|Participant Flow|Group A, Control Group|Supportive care only
422171|NCT00527319|O3|Outcome|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
422172|NCT00527319|O2|Outcome|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
422173|NCT00527319|O1|Outcome|Group A, Control Group|Supportive care only
422174|NCT00527319|O3|Outcome|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
422175|NCT00527319|O2|Outcome|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
422176|NCT00527319|O1|Outcome|Group A, Control Group|Supportive care only
422177|NCT00527319|E3|Reported Event|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
422178|NCT00527319|E2|Reported Event|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
422179|NCT00527319|E1|Reported Event|Group A, Control Group|Supportive care only
422180|NCT00527332|B3|Baseline|Total|Total of all reporting groups
422181|NCT00527332|B2|Baseline|General Anesthesia|General anesthesia
422182|NCT00527332|B1|Baseline|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
422183|NCT00527332|P2|Participant Flow|General Anesthesia|General anesthesia
422184|NCT00527332|P1|Participant Flow|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
422185|NCT00527332|O2|Outcome|General Anesthesia|General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
422186|NCT00527332|O1|Outcome|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.
422187|NCT00527332|E2|Reported Event|General Anesthesia|General anesthesia
422188|NCT00527332|E1|Reported Event|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
422189|NCT00527397|B1|Baseline|All Subjects With Type 1 or Type 2 Diabetes Mellitus|All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
422190|NCT00527397|P1|Participant Flow|All Subjects With Type 1 or Type 2 Diabetes Mellitus|All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
422191|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
422192|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
422193|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
422194|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
422195|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
422196|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
422197|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
422198|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
422199|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
422200|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
422201|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
422202|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
422203|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
422204|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
422205|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
422206|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
422207|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
422208|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
422209|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
422210|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
422211|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
422212|NCT00527397|E1|Reported Event|All Subjects With Type 1 or Type 2 Diabetes Mellitus|all subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
422243|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422244|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422245|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422246|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422247|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422248|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422213|NCT00527423|B1|Baseline|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
422214|NCT00527423|P1|Participant Flow|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
422215|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or
422216|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|The study consisted of a treatment period from day 1 to week 152 (end of treatment), and a 4-week follow-up visit at week 156 (end of study). Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or
422217|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
422218|NCT00527423|E1|Reported Event|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
422219|NCT00527475|B3|Baseline|Total|Total of all reporting groups
422220|NCT00527475|B2|Baseline|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
422221|NCT00527475|B1|Baseline|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
422222|NCT00527475|P2|Participant Flow|Reduced Fluence PDT & Ranibizumab|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
422223|NCT00527475|P1|Participant Flow|Ranibizumab|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
422224|NCT00527475|O2|Outcome|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
422225|NCT00527475|O1|Outcome|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
422226|NCT00527475|E2|Reported Event|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
422227|NCT00527475|E1|Reported Event|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
422228|NCT00527488|B5|Baseline|Total|Total of all reporting groups
422229|NCT00527488|B4|Baseline|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422230|NCT00527488|B3|Baseline|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422231|NCT00527488|B2|Baseline|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422232|NCT00527488|B1|Baseline|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422233|NCT00527488|P4|Participant Flow|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422234|NCT00527488|P3|Participant Flow|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422235|NCT00527488|P2|Participant Flow|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422236|NCT00527488|P1|Participant Flow|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422237|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422238|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422239|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422240|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422241|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422242|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422251|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422252|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422253|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422254|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422255|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422256|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422257|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422258|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422259|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422260|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422261|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422262|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422263|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422264|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422265|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422266|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422267|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422268|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422269|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422270|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422271|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422272|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422273|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422274|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422275|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422276|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422277|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422278|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422279|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422280|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422281|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422282|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422283|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422284|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422285|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422286|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422287|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422288|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422289|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422290|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422291|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422292|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422293|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422294|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422295|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422296|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422297|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422298|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422299|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422300|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422301|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422302|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422303|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422304|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422305|NCT00527488|E4|Reported Event|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
422306|NCT00527488|E3|Reported Event|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
422307|NCT00527488|E2|Reported Event|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
422308|NCT00527488|E1|Reported Event|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
422309|NCT00532883|B5|Baseline|Total|Total of all reporting groups
422310|NCT00532883|B4|Baseline|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
422311|NCT00532883|B3|Baseline|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
422312|NCT00532883|B2|Baseline|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
422313|NCT00532883|B1|Baseline|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
422314|NCT00532883|P4|Participant Flow|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
422315|NCT00532883|P3|Participant Flow|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
442780|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
422316|NCT00532883|P2|Participant Flow|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
422317|NCT00532883|P1|Participant Flow|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
422318|NCT00532883|O4|Outcome|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
422319|NCT00532883|O3|Outcome|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
422320|NCT00532883|O2|Outcome|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
422321|NCT00532883|O1|Outcome|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
422322|NCT00532883|E4|Reported Event|Placebo/Placebo|
422323|NCT00532883|E3|Reported Event|Placebo/Magnesium Pidolate|20 mg/kg/day HU + 0.6 mEq/kg/day Mg
422324|NCT00532883|E2|Reported Event|Hydroxyurea/Placebo|0.6 mEq/kg/day
422325|NCT00532883|E1|Reported Event|Hydroxyurea/Magnesium Pidolate|20 mg/kg/day
422326|NCT00532935|B3|Baseline|Total|Total of all reporting groups
422327|NCT00532935|B2|Baseline|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422328|NCT00532935|B1|Baseline|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422329|NCT00532935|P2|Participant Flow|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422330|NCT00532935|P1|Participant Flow|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422331|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422332|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422333|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422334|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422335|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422336|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422337|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422338|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422339|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422340|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422341|NCT00532935|E2|Reported Event|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422342|NCT00532935|E1|Reported Event|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
422343|NCT00532948|B4|Baseline|Total|Total of all reporting groups
422344|NCT00532948|B3|Baseline|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
422345|NCT00532948|B2|Baseline|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
422346|NCT00532948|B1|Baseline|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
422347|NCT00532948|P3|Participant Flow|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
422348|NCT00532948|P2|Participant Flow|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
422349|NCT00532948|P1|Participant Flow|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
422350|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422351|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422352|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422353|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422354|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422355|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422356|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422357|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422358|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422359|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422360|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422361|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422514|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
422362|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422363|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422364|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422365|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422366|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422367|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422368|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422369|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422370|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422371|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422372|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422373|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422374|NCT00532948|O1|Outcome|Capecitabine (Overall)|Capecitabine 500, 650, and 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422375|NCT00532948|E3|Reported Event|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422376|NCT00532948|E2|Reported Event|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422377|NCT00532948|E1|Reported Event|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
422378|NCT00533702|B3|Baseline|Total|Total of all reporting groups
422379|NCT00533702|B2|Baseline|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422380|NCT00533702|B1|Baseline|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422381|NCT00533702|P2|Participant Flow|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422382|NCT00533702|P1|Participant Flow|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422383|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422384|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422385|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422473|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422386|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422387|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422388|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422389|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422390|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422391|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422392|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422393|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422394|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422395|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422396|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422397|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422398|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422399|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422400|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422401|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422402|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422403|NCT00533702|E2|Reported Event|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
422404|NCT00533702|E1|Reported Event|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
422405|NCT00533897|B4|Baseline|Total|Total of all reporting groups
422406|NCT00533897|B3|Baseline|Placebo Received in Period 2|Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to Placebo (Day 85-169).
422474|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
422407|NCT00533897|B2|Baseline|Abatacept Received in Period 2|Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to ABA (Day 85-169).
422408|NCT00533897|B1|Baseline|Period 1 Non-Responders|Participants received abatacept (ABA) intravenous (IV) loading dose and subcutaneous (SC) injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 non-responders skipped Periods 2 and 3 and entered the long term extension (LTE).
422409|NCT00533897|P8|Participant Flow|Long Term Extension (LTE) Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422410|NCT00533897|P7|Participant Flow|Long Term Extension Abatacept for LI Period Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve Disease Activity Score 28 (DAS28-CRP) decrease by ≥ 0.6 from Day 1), they directly entered the Long Term Extension (LTE) receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422411|NCT00533897|P6|Participant Flow|PLA Switched to ABA With PLA IV Loading Dose in RI Period|After receiving ABA in the Lead-In, and PLA in the DBW Period, participants were randomized to receive a single Placebo IV loading dose on Day 169 followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
422412|NCT00533897|P5|Participant Flow|PLA Switched to ABA With ABA IV Loading Dose in RI Period|After receiving ABA in LI period, and PLA in the DBW Period, participants were randomized to receive a single weight-titered ABA IV loading dose (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
422413|NCT00533897|P4|Participant Flow|ABA With IV PLA Loading Dose in Re-introduction (RI) Period|After receiving ABA in LI Period, and ABA in DBW Period, participants received a single blinded placebo IV dose on Day 169 and continued with weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg) in the RI Period.
422414|NCT00533897|P3|Participant Flow|Placebo (PLA) Double Blind Withdrawal (DBW)|After receiving ABA in the LI Period, participants received double blind Placebo SC injections starting on Day 85 and weekly for 12 weeks.
422415|NCT00533897|P2|Participant Flow|Abatacept (ABA) Double-blind Withdrawal (DBW)|After receiving ABA in the LI, participants received double blind ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422416|NCT00533897|P1|Participant Flow|Abatacept (ABA) [Lead-In (LI)]|On Day 1 of the 12 week Lead-In (LI), participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422417|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422418|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422419|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422420|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422421|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422475|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422630|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
422422|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422423|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422424|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422425|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422426|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422427|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422428|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422429|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422430|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422431|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422432|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422476|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422631|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
422433|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422434|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422435|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422436|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422437|NCT00533897|O1|Outcome|LTE Abatacept for All Participants|This group includes all participants who received at least one dose of 125 mg SC Abatacept during the LTE and includes both the LI Period 1 non-responder and the ST Completer cohorts.
422438|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422439|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422440|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422441|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422442|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422443|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422444|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
422477|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
439630|NCT00577135|O3|Outcome|Low Intensification|
422445|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
422446|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422447|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422448|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422449|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422450|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
422451|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422452|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422453|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
422454|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422455|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422456|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
422457|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422458|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422459|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
422460|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422461|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422462|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
422463|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422464|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422465|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
422466|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422467|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422468|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
422469|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422470|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422471|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
422472|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422478|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422479|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422480|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
422481|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422482|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422483|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422484|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422485|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422486|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422487|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422488|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422489|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422490|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422491|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422492|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422493|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422494|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422495|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422496|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422497|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422498|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422499|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422500|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422501|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422502|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422503|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422504|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422505|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422506|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422507|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422508|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422509|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
422510|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
422511|NCT00533897|O2|Outcome|PLA [DB]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422512|NCT00533897|O1|Outcome|ABA [DB]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
422513|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422515|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422516|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422517|NCT00533897|O2|Outcome|PLA [DB]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422518|NCT00533897|O1|Outcome|ABA [DB]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
422519|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422520|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
422521|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422522|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
422523|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422524|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
422525|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422526|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
422527|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422528|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
422529|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422530|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422531|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422532|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422533|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422534|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422535|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422536|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422537|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422538|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422539|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422540|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
422541|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
422542|NCT00533897|O1|Outcome|Abatacept in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
422543|NCT00533897|O1|Outcome|Abatacept in Lead-In Period|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422544|NCT00533897|O1|Outcome|Abatacept in Lead-In Period|On Day 1, participants received a single intravenous (IV) Abatacept (ABA) dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
422545|NCT00533897|O2|Outcome|PLA Switched to ABA With PLA IV Loading Dose in RI Period|On Day 169, participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period.
422546|NCT00533897|O1|Outcome|PLA Switched to ABA With ABA IV Loading Dose in RI Period|On Day 169, participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period.
422547|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
422548|NCT00533897|O1|Outcome|Abatacept in DBW Period|Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
422549|NCT00533897|E4|Reported Event|Placebo Received in Period 2|Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Placebo SC injections starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were administered during Reintroduction Period 3 and during the LTE Period until completion of the LTE.
422550|NCT00533897|E3|Reported Event|Abatacept Received in Period 2|Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Abatacept SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were continued in Reintroduction Period 3 and during the LTE Period until completion of the LTE.
422551|NCT00533897|E2|Reported Event|Period 1 Non-Responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 until completion of the LTE.
439631|NCT00577135|O2|Outcome|Continuous Infusion|
422552|NCT00533897|E1|Reported Event|Period 1 Non-Completers|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. These participants did not complete the Period and did not continue in the study.
422553|NCT00533949|B5|Baseline|Total|Total of all reporting groups
422554|NCT00533949|B4|Baseline|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
422555|NCT00533949|B3|Baseline|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
422556|NCT00533949|B2|Baseline|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
422557|NCT00533949|B1|Baseline|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
422558|NCT00533949|P4|Participant Flow|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
422559|NCT00533949|P3|Participant Flow|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
422560|NCT00533949|P2|Participant Flow|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
422561|NCT00533949|P1|Participant Flow|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
422562|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
422563|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
422564|NCT00533949|O4|Outcome|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
422565|NCT00533949|O3|Outcome|60 Gy RT + Cetuximab|60 gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
422566|NCT00533949|O2|Outcome|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
422567|NCT00533949|O1|Outcome|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
422568|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
422569|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
422570|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
422571|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
422572|NCT00533949|O4|Outcome|Combined Patients From Arms Receiving No Cetuximab|Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
422573|NCT00533949|O3|Outcome|Combined Patients Receiving Cetuximab|Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)
422574|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
422575|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
422576|NCT00533949|O4|Outcome|Combined Patients From Arms Receiving No Cetuximab|Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
422577|NCT00533949|O3|Outcome|Combined Patients Receiving Cetuximab|Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)
422578|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
422579|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
422580|NCT00533949|O4|Outcome|Combined Patients From Arms Receiving No Cetuximab|Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
422581|NCT00533949|O3|Outcome|Combined Patients Receiving Cetuximab|Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)
422582|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
422583|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)
422584|NCT00533949|E4|Reported Event|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
422585|NCT00533949|E3|Reported Event|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
422586|NCT00533949|E2|Reported Event|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
422587|NCT00533949|E1|Reported Event|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
422588|NCT00534001|B3|Baseline|Total|Total of all reporting groups
422589|NCT00534001|B2|Baseline|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.
bupropion hydrochloride: Given orally"
422590|NCT00534001|B1|Baseline|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.
bupropion hydrochloride: Given orally
placebo: Given orally"
422591|NCT00534001|P2|Participant Flow|4-week Run-in (Extended)|
422592|NCT00534001|P1|Participant Flow|1-week Run In (Standard)|
422593|NCT00534001|O2|Outcome|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.
bupropion hydrochloride: Given orally"
422594|NCT00534001|O1|Outcome|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.
bupropion hydrochloride: Given orally
placebo: Given orally"
422595|NCT00534001|O2|Outcome|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.
bupropion hydrochloride: Given orally"
422596|NCT00534001|O1|Outcome|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.
bupropion hydrochloride: Given orally
placebo: Given orally"
422597|NCT00534001|E2|Reported Event|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.
bupropion hydrochloride: Given orally"
422598|NCT00534001|E1|Reported Event|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.
bupropion hydrochloride: Given orally
placebo: Given orally"
422599|NCT00534092|B3|Baseline|Total|Total of all reporting groups
422600|NCT00534092|B2|Baseline|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
422601|NCT00534092|B1|Baseline|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
422602|NCT00534092|P2|Participant Flow|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
422603|NCT00534092|P1|Participant Flow|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
422604|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
422605|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
422606|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
422607|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
422608|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
422609|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
422610|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
422611|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
422612|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
422613|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
422614|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
422615|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
422616|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
422617|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
422618|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
422619|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
422620|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
422621|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
422622|NCT00534092|E3|Reported Event|Total|Total patients included target group and safety group.
422623|NCT00534092|E2|Reported Event|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
422624|NCT00534092|E1|Reported Event|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
422625|NCT00534105|B3|Baseline|Total|Total of all reporting groups
422626|NCT00534105|B2|Baseline|Normal Pregnancies|Normal pregnant women without gestational diabetes
422627|NCT00534105|B1|Baseline|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
422628|NCT00534105|P2|Participant Flow|Normal Pregnancies|Normal pregnant women without gestational diabetes
422629|NCT00534105|P1|Participant Flow|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
422632|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
422633|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
422634|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
422635|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
422636|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
422637|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
422638|NCT00534105|E2|Reported Event|Normal Pregnancies|Normal pregnant women without gestational diabetes
422639|NCT00534105|E1|Reported Event|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
422640|NCT00534209|B1|Baseline|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.
Given intradermally."
422641|NCT00534209|P1|Participant Flow|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.
Given intradermally."
422642|NCT00534209|O1|Outcome|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.
Given intradermally."
422643|NCT00534209|E1|Reported Event|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.
Given intradermally."
422644|NCT00534248|B3|Baseline|Total|Total of all reporting groups
422645|NCT00534248|B2|Baseline|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
422646|NCT00534248|B1|Baseline|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
422647|NCT00534248|P2|Participant Flow|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
422648|NCT00534248|P1|Participant Flow|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
422649|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
422650|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
422651|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
422652|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
422653|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
422654|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
422655|NCT00534248|E2|Reported Event|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
422656|NCT00534248|E1|Reported Event|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
422657|NCT00534313|B5|Baseline|Total|Total of all reporting groups
422658|NCT00534313|B4|Baseline|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
422659|NCT00534313|B3|Baseline|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422660|NCT00534313|B2|Baseline|Abatacept 10/10|Participants were administered iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
422661|NCT00534313|B1|Baseline|Abatacept 30/10|Participants were administered intravenous (iv) infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight i.e. for participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000 mg.
422662|NCT00534313|P4|Participant Flow|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
422663|NCT00534313|P3|Participant Flow|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422664|NCT00534313|P2|Participant Flow|Abatacept 10/10|Participants were administered iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
422665|NCT00534313|P1|Participant Flow|Abatacept 30/10|Participants were administered intravenous (iv) infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight i.e. for participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000 mg.
423035|NCT00535002|E1|Reported Event|Cocaine Females|Cocaine-dependent females
423036|NCT00535132|B3|Baseline|Total|Total of all reporting groups
422666|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
422667|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422668|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000mg).
422669|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422670|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
422671|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422672|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
422673|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg -calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422674|NCT00534313|O4|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
422675|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422676|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
422677|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422678|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422679|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg).
422680|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422681|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422682|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
422683|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422684|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
422685|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422686|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
422687|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg.
422688|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422689|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 169. All participants received a dose based on their screening visit weight as per by rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg).
422690|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422691|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
422692|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose based on their screening visit weight.
422693|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
422694|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
422695|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422696|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422697|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
422698|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
422699|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
422700|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422701|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
422751|NCT00534313|O1|Outcome|All Treated Participants|Long-term period: All participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422702|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422703|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
422704|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422705|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
422706|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422707|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
422708|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422709|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
422710|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422711|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
422712|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422713|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
422714|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422715|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
422716|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422717|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
422718|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422719|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
422853|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422720|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422721|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
422722|NCT00534313|O1|Outcome|Abatacept 30/10|Participants who received iv infusions of abatacept (30 mg/kg-calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422723|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
422724|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422725|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
422726|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
422727|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
422728|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422729|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg).
422730|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
422731|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422732|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422733|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422734|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422735|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422736|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422737|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422738|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422739|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422740|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422741|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422742|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422743|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422744|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422745|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422746|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422747|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422748|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422749|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg). Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422750|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422854|NCT00534495|O3|Outcome|Week 24- All Subjects|
422752|NCT00534313|E5|Reported Event|Placebo (Short-term Period)|Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
422753|NCT00534313|E4|Reported Event|Abatacept (Long-term Period)|Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
422754|NCT00534313|E3|Reported Event|Abatacept 30/10 (Short-term Period)|Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
422755|NCT00534313|E2|Reported Event|Abatacept 3/3 (Short-term Period)|Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
422756|NCT00534313|E1|Reported Event|Abatacept 10/10 (Short-term Period)|Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
422757|NCT00534352|B1|Baseline|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.
In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.
In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.
Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
422758|NCT00534352|P1|Participant Flow|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.
In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.
In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.
Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
422759|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.
In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.
In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.
Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
422760|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.
In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.
In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.
Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
422761|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.
In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.
In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.
Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
422855|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422856|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422857|NCT00534495|O3|Outcome|Week 24- All Subjects|
423117|NCT00535288|B3|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
422762|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.
In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.
In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.
Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
422763|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
422764|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
422765|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
422766|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
422767|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
422768|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
422769|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
422770|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
422771|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
422772|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
422773|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
422774|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
422775|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
422776|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
422777|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
422778|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
422779|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
422780|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
422781|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
422782|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
422783|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
422784|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
422785|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
422786|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
422787|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
422788|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
422789|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
422790|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
422791|NCT00534352|O2|Outcome|Treatment B: TMC125 + TDF/FTC + DRV/Rtv|Treatment B: TMC125 + TDF/FTC + DRV/rtv.
422792|NCT00534352|O1|Outcome|Treatment A: TMC125 + TDF/FTC|Treatment A: TMC125 + TDF/FTC.
422793|NCT00534352|E4|Reported Event|Optional Extension|DRV/rtv + TDF/FTC
422794|NCT00534352|E3|Reported Event|Treatment C|DRV/rtv + TDF/FTC
422795|NCT00534352|E2|Reported Event|Treatment B|TMC125 + TDF/FTC + DRV/rtv
422796|NCT00534352|E1|Reported Event|Treatment A|TMC125 + TDF/FTC
422797|NCT00534365|B3|Baseline|Total|Total of all reporting groups
422798|NCT00534365|B2|Baseline|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling"
422799|NCT00534365|B1|Baseline|TVT Procedure|"Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling"
422800|NCT00534365|P2|Participant Flow|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling"
422801|NCT00534365|P1|Participant Flow|TVT Procedure|"Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling"
422802|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling"
422803|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling"
422804|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling"
422805|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling"
422806|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling"
422807|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling"
422808|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling"
422809|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling"
422810|NCT00534365|O2|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling"
422811|NCT00534365|O1|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling"
422812|NCT00534365|E2|Reported Event|TVT Procedure|"Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling"
422813|NCT00534365|E1|Reported Event|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling"
422814|NCT00534404|B4|Baseline|Total|Total of all reporting groups
422815|NCT00534404|B3|Baseline|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422816|NCT00534404|B2|Baseline|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422858|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422817|NCT00534404|B1|Baseline|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422818|NCT00534404|P3|Participant Flow|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422819|NCT00534404|P2|Participant Flow|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422820|NCT00534404|P1|Participant Flow|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422821|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422822|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422823|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422824|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422825|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422826|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422827|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422828|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422829|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422830|NCT00534404|E3|Reported Event|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422831|NCT00534404|E2|Reported Event|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
423024|NCT00535002|O8|Outcome|Control Males Placebo|
422832|NCT00534404|E1|Reported Event|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
422833|NCT00534417|B1|Baseline|Treatment Group: Capecitabine/Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422834|NCT00534417|P1|Participant Flow|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg orally (po) in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422835|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422836|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422837|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422838|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422839|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422840|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422841|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422842|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422843|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422844|NCT00534417|E1|Reported Event|Treatment Group: Capecitabine/Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
422845|NCT00534495|B3|Baseline|Total|Total of all reporting groups
422846|NCT00534495|B2|Baseline|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422847|NCT00534495|B1|Baseline|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422848|NCT00534495|P3|Participant Flow|Long Term Extension All Participants|All participants who benefited from rilonacept were eligible to enroll this phase and receive rilonacept 2.2mg/kg weekly
422849|NCT00534495|P2|Participant Flow|Placebo|"Placebo loading dose followed by maintenance dose for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the long term extension
Rilonacept: 2.2 mg/kg subcutaneously"
422850|NCT00534495|P1|Participant Flow|Rilonacept|Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week followed by a placebo loading dose and then rilonacept in the long term extension phase Rilonacept: 2.2 mg/kg subcutaneously
422851|NCT00534495|O3|Outcome|Long Term Extension 24 Weeks to 21 Months|
422852|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
423025|NCT00535002|O7|Outcome|Control Males Yohimbine|
422859|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422860|NCT00534495|O3|Outcome|Week 24- All Subjects|
422861|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422862|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422863|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422864|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422865|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422866|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422867|NCT00534495|E5|Reported Event|Long Term Extension 24 Weeks to 21 Months|
422868|NCT00534495|E4|Reported Event|Placebo Week (4-24)|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422869|NCT00534495|E3|Reported Event|Rilonacept Week (4-24)|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422870|NCT00534495|E2|Reported Event|Placebo Week (0-4)|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422871|NCT00534495|E1|Reported Event|Rilonacept Week (0-4)|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously"
422872|NCT00534599|B3|Baseline|Total|Total of all reporting groups
422873|NCT00534599|B2|Baseline|Placebo|Matching placebo tablets once daily
422874|NCT00534599|B1|Baseline|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422875|NCT00534599|P2|Participant Flow|Placebo|Matching placebo tablets once daily
422876|NCT00534599|P1|Participant Flow|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422877|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422878|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422879|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422880|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422881|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422882|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422883|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422884|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422885|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422886|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422887|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422888|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422889|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422890|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422891|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422892|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422893|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422894|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422895|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422896|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422897|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422898|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422899|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422900|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422901|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422902|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422903|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422904|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422905|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
422906|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422907|NCT00534599|E2|Reported Event|Placebo|Matching placebo tablets once daily
422908|NCT00534599|E1|Reported Event|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
422909|NCT00534638|B3|Baseline|Total|Total of all reporting groups
422910|NCT00534638|B2|Baseline|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422911|NCT00534638|B1|Baseline|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422912|NCT00534638|P2|Participant Flow|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
423026|NCT00535002|O6|Outcome|Control Females Placebo|
423027|NCT00535002|O5|Outcome|Control Females Yohimbine|
422913|NCT00534638|P1|Participant Flow|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422914|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422915|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422916|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422917|NCT00534638|O1|Outcome|Cervarix Pooled Group|Female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422918|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422919|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422920|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422921|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422922|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422923|NCT00534638|O1|Outcome|Cervarix Pooled Group|male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422924|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422925|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422926|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422927|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422928|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422929|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422930|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422931|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422932|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422933|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422934|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422935|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422936|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422937|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422938|NCT00534638|O2|Outcome|Cervarix/Engerix-B Pooled Group|Male and female subjects receiving Cervarix™/Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422939|NCT00534638|O1|Outcome|No-vaccine Group|Subjects who were enrolled but not vaccinated.
422940|NCT00534638|O3|Outcome|Engerix-B Group|All adolescents were vaccinated with Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422941|NCT00534638|O2|Outcome|Cervarix/Engerix-B B Group|90% of the female adolescents received Cervarix™ vaccine. Male adolescents and rest of the female adolescents received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
423028|NCT00535002|O4|Outcome|Cocaine Males Placebo|Cocaine-dependent males pre-treated with placebo
423029|NCT00535002|O3|Outcome|Cocaine Males Yohimbine|Cocaine-dependent males pre-treated with yohimbine
422942|NCT00534638|O1|Outcome|Cervarix/Engerix-B A Group|90% of male and female adolescents received Cervarix™ vaccine. Rest of the subjects received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422943|NCT00534638|E2|Reported Event|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422944|NCT00534638|E1|Reported Event|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
422945|NCT00534794|B3|Baseline|Total|Total of all reporting groups
422946|NCT00534794|B2|Baseline|Pataday|1 drop each eye for 1 day
422947|NCT00534794|B1|Baseline|Elestat|1 drop each eye for 2 days
422948|NCT00534794|P2|Participant Flow|Pataday|1 drop each eye for 1 day
422949|NCT00534794|P1|Participant Flow|Elestat|1 drop each eye for 2 days
422950|NCT00534794|O2|Outcome|Pataday|1 drop each eye for 1 day
422951|NCT00534794|O1|Outcome|Elestat|1 drop each eye for 2 days
422952|NCT00534794|O2|Outcome|Pataday|1 drop each eye for 1 day
422953|NCT00534794|O1|Outcome|Elestat|1 drop each eye for 2 days
422954|NCT00534794|E2|Reported Event|Pataday|1 drop each eye for 1 day
422955|NCT00534794|E1|Reported Event|Elestat|1 drop each eye for 2 days
422956|NCT00534833|B3|Baseline|Total|Total of all reporting groups
422957|NCT00534833|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
422958|NCT00534833|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
422959|NCT00534833|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with OPV at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
422960|NCT00534833|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP~T concomitantly with OPV at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP~T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
422961|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
422962|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
422963|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
422964|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
422965|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203
422966|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203.
422967|NCT00534833|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
422968|NCT00534833|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
422969|NCT00534937|B3|Baseline|Total|Total of all reporting groups
422970|NCT00534937|B2|Baseline|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
422971|NCT00534937|B1|Baseline|Standard Compression|Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).
422972|NCT00534937|P2|Participant Flow|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
422973|NCT00534937|P1|Participant Flow|Standard Compression|Patients in this arm will receive current standard of care (once-weekly short-stretch compression wrapping).
422974|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
422975|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once-weekly short-stretch compression wrapping).
423030|NCT00535002|O2|Outcome|Cocaine Females Placebo|Cocaine-dependent females pre-treated with placebo
422976|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
422977|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
422978|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
422979|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
422980|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
422981|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
422982|NCT00534937|E2|Reported Event|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
422983|NCT00534937|E1|Reported Event|Standard Compression|Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).
422984|NCT00534976|B3|Baseline|Total|Total of all reporting groups
422985|NCT00534976|B2|Baseline|Placebo/ Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
422986|NCT00534976|B1|Baseline|Montelukast/ Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
422987|NCT00534976|P2|Participant Flow|Placebo/ Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
422988|NCT00534976|P1|Participant Flow|Montelukast/ Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
422989|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
422990|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
422991|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
422992|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
422993|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
422994|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
423031|NCT00535002|O1|Outcome|Cocaine Females Yohimbine|Cocaine-dependent females pre-treated with yohimbine
423032|NCT00535002|E4|Reported Event|Control Males|Non-dependent males
423033|NCT00535002|E3|Reported Event|Control Females|Non-dependent females
422995|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
422996|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
422997|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
422998|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
422999|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
423000|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
423001|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
423002|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
423003|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
423004|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
423005|NCT00534976|E2|Reported Event|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
423006|NCT00534976|E1|Reported Event|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
423007|NCT00535002|B9|Baseline|Total|Total of all reporting groups
423008|NCT00535002|B8|Baseline|Control Males, Placebo Then Yohimbine|non-dependent males, received placebo day and yohimbine day 2
423009|NCT00535002|B7|Baseline|Control Males, Yohimbine Then Placebo|non-dependent males, received yohimbine day and placebo day 2
423010|NCT00535002|B6|Baseline|Control Females, Placebo Then Yohimbine|non-dependent females, received placebo day and yohimbine day 2
423011|NCT00535002|B5|Baseline|Control Females, Yohimbine Then Placebo|non-dependent females, received yohimbine day and placebo day 2
423012|NCT00535002|B4|Baseline|Cocaine Males, Placebo Then Yohimbine|Cocaine-dependent males, received placebo day 1, yohimbine day 2
423013|NCT00535002|B3|Baseline|Cocaine Males, Yohimbine Then Placebo|Cocaine-dependent males, received yohimbine day 1, placebo day 2
423014|NCT00535002|B2|Baseline|Cocaine Females, Placebo Then Yohimbine|Cocaine-dependent females, received placebo day 1, yohimbine day 2
423015|NCT00535002|B1|Baseline|Cocaine Females, Yohimbine Then Placebo|Cocaine-dependent females, received yohimbine day 1, placebo day 2
423016|NCT00535002|P8|Participant Flow|Control Males, Placebo Then Yohimbine|Non-dependent males, placebo then yohimbine
423017|NCT00535002|P7|Participant Flow|Control Females, Placebo Then Yohimbine|Non-dependent females, placebo then yohimbine
423018|NCT00535002|P6|Participant Flow|Cocaine Males, Placebo Then Yohimbine|Cocaine-dependent males, Placebo then Yohimbine
423019|NCT00535002|P5|Participant Flow|Cocaine Females, Placebo Then Yohimbine|Cocaine females-dependent females, Placebo then yohimbine
423020|NCT00535002|P4|Participant Flow|Control Males, Yohimbine Then Placebo|Non-dependent males, Yohimbine then placebo
423021|NCT00535002|P3|Participant Flow|Control Females, Yohimbine Then Placebo|Non-dependent females, Yohimbine then placebo
423022|NCT00535002|P2|Participant Flow|Cocaine Males, Yohimbine Then Placebo|Cocaine-dependent males, Yohimbine then placebo
423023|NCT00535002|P1|Participant Flow|Cocaine Females, Yohimbine Then Placebo|Cocaine-dependent females, Yohimbine then placebo
423037|NCT00535132|B2|Baseline|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were then to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423038|NCT00535132|B1|Baseline|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423039|NCT00535132|P2|Participant Flow|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423040|NCT00535132|P1|Participant Flow|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423041|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423042|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423043|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423044|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423045|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423046|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423047|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423048|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423049|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423050|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423051|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423052|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423053|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423054|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423055|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423056|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423057|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423058|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423059|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423060|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423061|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423062|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423063|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423064|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423065|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423066|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423067|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423068|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423069|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423070|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423071|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423072|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423073|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423074|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423075|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423076|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423077|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423078|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423079|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423080|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423081|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423082|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423083|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423084|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423085|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423086|NCT00535132|E3|Reported Event|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
423087|NCT00535132|E2|Reported Event|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
423088|NCT00535132|E1|Reported Event|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
423089|NCT00535145|B1|Baseline|Study Treatment|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
423090|NCT00535145|P1|Participant Flow|Study Treatment|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone)
423091|NCT00535145|O2|Outcome|Paliperidone ER Phase|Day 28 through Day 62 (1 week cross titration plus 4 weeks mono-therapy).
423092|NCT00535145|O1|Outcome|TAU Phase|Day 1 through Day 27 (4 weeks)
423093|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
423094|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
423095|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
423260|NCT00535405|E5|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg once daily for 12 weeks
423096|NCT00535145|E3|Reported Event|TAU - All Enrolled Participants|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
423097|NCT00535145|E2|Reported Event|Paliperidone ER Phase|Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
423098|NCT00535145|E1|Reported Event|TAU - Pali ER|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks who went on to participate in Phase 2 (Paliperidone ER Phase).
423099|NCT00535223|B3|Baseline|Total|Total of all reporting groups
423100|NCT00535223|B2|Baseline|Present Centered Group Therapy|"Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
423101|NCT00535223|B1|Baseline|Group Based Exposure Therapy|Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
423102|NCT00535223|P2|Participant Flow|Present Centered Group Therapy|"Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
423103|NCT00535223|P1|Participant Flow|Group Based Exposure Therapy|Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
423104|NCT00535223|O2|Outcome|Present Centered Group Therapy|The group met twice a week for 16 weeks for 90 minutes per session. The focus was on dealing with problem solving in the here and now while avoiding traumatic material.
423105|NCT00535223|O1|Outcome|Group Based Exposure Therapy|"See below
Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking."
423106|NCT00535223|O2|Outcome|Present Centered Group Therapy|The group met twice a week for 16 weeks for 90 minutes per session. The focus was on dealing with problem solving in the here and now while avoiding traumatic material.
423107|NCT00535223|O1|Outcome|Group Based Exposure Therapy|"See below
Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking."
423108|NCT00535223|E2|Reported Event|Present Centered Group Therapy|Present Centered Group Therapy. No serious adverse events occurred in response to this treatment.
423109|NCT00535223|E1|Reported Event|Group Based Exposure Therapy|Group Based Exposure Therapy. No serious adverse events occurred in response to this treatment.
423110|NCT00535262|B1|Baseline|Open EmSam|8-week open-label treatment with EmSam
423111|NCT00535262|P1|Participant Flow|EmSam|"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.
EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
423112|NCT00535262|O1|Outcome|EmSam|"EmSam was administered in open-label fashion during phase I of the study during which symptoms of depression were assessed weekly. The study was terminated early so the data are not reported.
EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
423113|NCT00535262|E1|Reported Event|EmSam|"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.
EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
423114|NCT00535288|B6|Baseline|Total|Total of all reporting groups
423115|NCT00535288|B5|Baseline|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
423116|NCT00535288|B4|Baseline|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
439632|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
423118|NCT00535288|B2|Baseline|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423119|NCT00535288|B1|Baseline|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423120|NCT00535288|P5|Participant Flow|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
423121|NCT00535288|P4|Participant Flow|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423122|NCT00535288|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423123|NCT00535288|P2|Participant Flow|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423124|NCT00535288|P1|Participant Flow|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
423125|NCT00535288|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
423126|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally, QD for up to 12 weeks
423127|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423128|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423129|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423130|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
423131|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally, QD for up to 12 weeks
423132|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423133|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423134|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily QD for up to 12 weeks.
423135|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
423136|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423137|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423138|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423139|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423140|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
423141|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423142|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423143|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423144|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423145|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
423146|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423147|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423148|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423149|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423150|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
423151|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423152|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423153|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423154|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423155|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
423156|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423157|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423158|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423159|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423160|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
423161|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423162|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423163|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423164|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423165|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
423166|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423167|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423168|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423169|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423170|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
423171|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423172|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423173|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423174|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423175|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
423176|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423177|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423178|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423179|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423180|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
423181|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423182|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423183|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423184|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily QD for up to 12 weeks.
423185|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
423186|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423187|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423188|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423189|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
423190|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
423191|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423192|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423193|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423194|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
423195|NCT00535288|E5|Reported Event|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
423196|NCT00535288|E4|Reported Event|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
423197|NCT00535288|E3|Reported Event|Esmertazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
423198|NCT00535288|E2|Reported Event|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
423199|NCT00535288|E1|Reported Event|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
423200|NCT00535301|B3|Baseline|Total|Total of all reporting groups
423201|NCT00535301|B2|Baseline|Perigee|Anterior vaginal prolapse repair with graft
423202|NCT00535301|B1|Baseline|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
423203|NCT00535301|P2|Participant Flow|Perigee|Anterior vaginal prolapse repair with graft
423204|NCT00535301|P1|Participant Flow|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
423205|NCT00535301|O2|Outcome|Perigee|Anterior vaginal prolapse repair with graft
423206|NCT00535301|O1|Outcome|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
423207|NCT00535301|O2|Outcome|Perigee (Grafted Repair)|Anterior vaginal prolapse repair with graft
423208|NCT00535301|O1|Outcome|Anterior Colporrhaphy (Sutured Repair)|Sutured anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
423209|NCT00535301|O2|Outcome|Perigee|Anterior vaginal prolapse repair with graft
423210|NCT00535301|O1|Outcome|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
423211|NCT00535301|E2|Reported Event|Perigee|Anterior vaginal prolapse repair with graft
423212|NCT00535301|E1|Reported Event|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
423213|NCT00535392|B1|Baseline|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.
Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
423261|NCT00535405|E4|Reported Event|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
423214|NCT00535392|P1|Participant Flow|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.
Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
423215|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.
Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
423216|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.
Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
423217|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.
Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
423218|NCT00535392|E1|Reported Event|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.
Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
423219|NCT00535405|B6|Baseline|Total|Total of all reporting groups
423220|NCT00535405|B5|Baseline|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
423221|NCT00535405|B4|Baseline|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
423222|NCT00535405|B3|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
423223|NCT00535405|B2|Baseline|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
423224|NCT00535405|B1|Baseline|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
423225|NCT00535405|P5|Participant Flow|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
423226|NCT00535405|P4|Participant Flow|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
423227|NCT00535405|P3|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
423228|NCT00535405|P2|Participant Flow|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
423229|NCT00535405|P1|Participant Flow|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
423230|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
423231|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
423232|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
423233|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
423234|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
423235|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
423236|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
423237|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
423238|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
423239|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
423240|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
423241|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
423242|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
423243|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
423244|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
423245|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
423246|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
423247|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
423248|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
423249|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
423250|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
423251|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
423252|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
423253|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
423254|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
423255|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
423256|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
423257|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
423258|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
423259|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
423262|NCT00535405|E3|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
423263|NCT00535405|E2|Reported Event|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
423264|NCT00535405|E1|Reported Event|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
423265|NCT00535496|B3|Baseline|Total|Total of all reporting groups
423266|NCT00535496|B2|Baseline|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423267|NCT00535496|B1|Baseline|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423268|NCT00535496|P4|Participant Flow|Sugammadex 4.0 mg/kg, TOF-Watch® SX Non-dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
423269|NCT00535496|P3|Participant Flow|Sugammadex 4.0 mg/kg, TOF-Watch® SX Dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the dominant forearm and the PNS was on the non-dominant forearm.
423270|NCT00535496|P2|Participant Flow|Sugammadex 1.0 mg/kg, TOF-Watch® SX Non-dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
423271|NCT00535496|P1|Participant Flow|Sugammadex 1.0 mg/kg, TOF-Watch® SX Dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The Train of Four (TOF)-Watch® SX was on the dominant forearm and the peripheral nerve stimulator (PNS) was on the non-dominant forearm.
423272|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423273|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423274|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423275|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423276|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423277|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423278|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423279|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423280|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423281|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423282|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423283|NCT00535496|E2|Reported Event|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423663|NCT00543296|P1|Participant Flow|0.59 mg Fluocinolone Acetonide Implant|
423664|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
423284|NCT00535496|E1|Reported Event|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
423285|NCT00535587|B5|Baseline|Total|Total of all reporting groups
423286|NCT00535587|B4|Baseline|Placebo Pill and Attention Control|
423287|NCT00535587|B3|Baseline|Placebo Pill and Exercise|
423288|NCT00535587|B2|Baseline|Mestinon and Attention Control|
423289|NCT00535587|B1|Baseline|Mestinon & Exercise|
423290|NCT00535587|P4|Participant Flow|Placebo Pill and Attention Control|
423291|NCT00535587|P3|Participant Flow|Placebo Pill and Exercise|
423292|NCT00535587|P2|Participant Flow|Mestinon and Attention Control|
423293|NCT00535587|P1|Participant Flow|Mestinon & Exercise|
423294|NCT00535587|O2|Outcome|Placebo Pill/Attention Control|
423295|NCT00535587|O1|Outcome|Mestinon/Exercise|
423296|NCT00535587|E4|Reported Event|Placebo Pill and Attention Control|
423297|NCT00535587|E3|Reported Event|Placebo Pill and Exercise|
423298|NCT00535587|E2|Reported Event|Mestinon and Attention Control|
423299|NCT00535587|E1|Reported Event|Mestinon & Exercise|
423300|NCT00535652|B1|Baseline|Ertapenem|"Administration of 1 gram ertapenem I.V.
Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
423301|NCT00535652|P1|Participant Flow|Ertapenem|"Administration of 1 gram ertapenem I.V.
Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
423302|NCT00535652|O1|Outcome|Ertapenem|"Administration of 1 gram ertapenem I.V.
Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
423303|NCT00535652|E1|Reported Event|Ertapenem|"Administration of 1 gram ertapenem I.V.
Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
423304|NCT00535730|B3|Baseline|Total|Total of all reporting groups
423305|NCT00535730|B2|Baseline|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
423306|NCT00535730|B1|Baseline|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
423307|NCT00535730|P2|Participant Flow|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
423308|NCT00535730|P1|Participant Flow|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
423309|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
423310|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
423311|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
423312|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
423313|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
423314|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
423315|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
423316|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
423317|NCT00535730|O1|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
423318|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
423319|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
423320|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
423321|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
423322|NCT00535730|E2|Reported Event|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
423323|NCT00535730|E1|Reported Event|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
423324|NCT00535769|B3|Baseline|Total|Total of all reporting groups
423325|NCT00535769|B2|Baseline|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
423326|NCT00535769|B1|Baseline|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
423349|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
423665|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
423327|NCT00535769|P2|Participant Flow|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
423328|NCT00535769|P1|Participant Flow|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
423329|NCT00535769|O2|Outcome|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
423330|NCT00535769|O1|Outcome|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
423331|NCT00535769|O1|Outcome|Usefulness of Text Messaging System|Patients with text reminder system were asked their opinion of the usefulness of message reminder from 0-10 (0, not useful at all; 10,most useful)
423332|NCT00535769|O2|Outcome|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
423333|NCT00535769|O1|Outcome|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
423334|NCT00535769|E2|Reported Event|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
423335|NCT00535769|E1|Reported Event|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
423336|NCT00535782|B3|Baseline|Total|Total of all reporting groups
423337|NCT00535782|B2|Baseline|Placebo + MTX|During Part 1 of the study participants received placebo intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received 8 mg/kg TCZ IV every 4 weeks plus 7.5-25 mg MTX weekly.
423338|NCT00535782|B1|Baseline|TCZ + MTX|During Part 1 of the study participants received 8 mg/kg tocilizumab (TCZ) by intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received open-label 8 mg/kg TCZ every 4 weeks plus 7.5-25 mg MTX weekly.
423339|NCT00535782|P3|Participant Flow|Part 2: TCZ + MTX|During Part 2 of the study, from Week 24 to Week 104, all participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
423340|NCT00535782|P2|Participant Flow|Part 1: Placebo + MTX|During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
423341|NCT00535782|P1|Participant Flow|Part 1: TCZ + MTX|During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
423342|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
423343|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
423344|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
423345|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
423346|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
423347|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
423348|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
423437|NCT00536107|B2|Baseline|Docetaxel|docetaxel 60mg/m sq
423438|NCT00536107|B1|Baseline|Gefitinib|gefitinib 250mg
423350|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
423351|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
423352|NCT00535782|E3|Reported Event|All TCZ + MTX|Includes patients who received at least one dose of active tocilizumab (TCZ) regardless of when they received it during the study and whether it was double-blind (Part 1) or open-label (Part 2). Participants received 8 mg/kg TCZ by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
423353|NCT00535782|E2|Reported Event|Part 1: Placebo + MTX|During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
423354|NCT00535782|E1|Reported Event|Part 1: TCZ + MTX|During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
423355|NCT00535821|B3|Baseline|Total|Total of all reporting groups
423356|NCT00535821|B2|Baseline|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2
Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
423357|NCT00535821|B1|Baseline|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)
Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
423358|NCT00535821|P2|Participant Flow|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2
Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
423359|NCT00535821|P1|Participant Flow|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)
Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
423360|NCT00535821|O2|Outcome|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2
Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
423361|NCT00535821|O1|Outcome|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)
Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
423362|NCT00535821|E2|Reported Event|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2
Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
423363|NCT00535821|E1|Reported Event|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)
Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
423364|NCT00535847|B4|Baseline|Total|Total of all reporting groups
423365|NCT00535847|B3|Baseline|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
423366|NCT00535847|B2|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
423367|NCT00535847|B1|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
423368|NCT00535847|P3|Participant Flow|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
423369|NCT00535847|P2|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
423370|NCT00535847|P1|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
423371|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
423372|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
423439|NCT00536107|P2|Participant Flow|Docetaxel|docetaxel 60mg/m sq
423440|NCT00536107|P1|Participant Flow|Gefitinib|gefitinib 250mg
423373|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
423374|NCT00535847|O4|Outcome|Did Not Achieve eRVR/Did Not Achieve SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 [NCT00535847]).
423375|NCT00535847|O3|Outcome|Did Not Achieve eRVR/Achieved SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who did not achieve eRVR but achieved SVR in this study (VX06-950-107 [NCT00535847]).
423376|NCT00535847|O2|Outcome|Achieved eRVR/Did Not Achieve SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who achieved eRVR but did not achieve SVR in this study (VX06-950-107 [NCT00535847]).
423377|NCT00535847|O1|Outcome|Achieved eRVR/Achieved SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who achieved eRVR and SVR in this study (VX06-950-107 [NCT00535847]).
423378|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
423379|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
423380|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
423381|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
423382|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
423383|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
423384|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
423385|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
423386|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
423387|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
423388|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
423389|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
423441|NCT00536107|O2|Outcome|Docetaxel|docetaxel 60mg/m sq
423442|NCT00536107|O1|Outcome|Gefitinib|gefitinib 250mg
423443|NCT00536107|O2|Outcome|Docetaxel|docetaxel 60mg/m sq
423390|NCT00535847|E3|Reported Event|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
423391|NCT00535847|E2|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
423392|NCT00535847|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
423393|NCT00535873|B1|Baseline|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
423394|NCT00535873|P1|Participant Flow|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
423395|NCT00535873|O1|Outcome|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
423396|NCT00535873|E1|Reported Event|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
423397|NCT00535938|B3|Baseline|Total|Total of all reporting groups
423398|NCT00535938|B2|Baseline|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423399|NCT00535938|B1|Baseline|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423400|NCT00535938|P2|Participant Flow|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423401|NCT00535938|P1|Participant Flow|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423402|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423403|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423404|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423405|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423406|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423407|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423408|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423409|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423410|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423411|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423412|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423413|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423414|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423415|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423416|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423417|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423418|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423419|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423420|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423421|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423422|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423423|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423424|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423425|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423426|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423427|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423428|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423429|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423430|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423431|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423432|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423433|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423434|NCT00535938|E2|Reported Event|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
423435|NCT00535938|E1|Reported Event|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
423436|NCT00536107|B3|Baseline|Total|Total of all reporting groups
423448|NCT00536120|B2|Baseline|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
423449|NCT00536120|B1|Baseline|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
423450|NCT00536120|P2|Participant Flow|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
423451|NCT00536120|P1|Participant Flow|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
423452|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
423453|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
423454|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
423455|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
423456|NCT00536120|O2|Outcome|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
423457|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
423458|NCT00536120|O2|Outcome|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
423459|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
423460|NCT00536120|E2|Reported Event|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at specified timepoints. They did not receive any treatment for their MS.
423461|NCT00536120|E1|Reported Event|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at specified timepoints following the 7th dose.
423462|NCT00536172|B3|Baseline|Total|Total of all reporting groups
423463|NCT00536172|B2|Baseline|Placebo|"Participants will receive treatment with placebo
Placebo: Placebo distribution matches the active medication."
423464|NCT00536172|B1|Baseline|Escitalopram|"Participants will receive treatment with escitalopram
Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
423465|NCT00536172|P2|Participant Flow|Placebo|"Participants will receive treatment with placebo
Placebo: Placebo distribution matches the active medication."
423466|NCT00536172|P1|Participant Flow|Escitalopram|"Participants will receive treatment with escitalopram
Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
423467|NCT00536172|O2|Outcome|Placebo|"Participants will receive treatment with placebo
Placebo: Placebo distribution matches the active medication."
423468|NCT00536172|O1|Outcome|Escitalopram|"Participants will receive treatment with escitalopram
Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
423469|NCT00536172|E2|Reported Event|Placebo|"Participants will receive treatment with placebo
Placebo: Placebo distribution matches the active medication."
423470|NCT00536172|E1|Reported Event|Escitalopram|"Participants will receive treatment with escitalopram
Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
423471|NCT00541970|B5|Baseline|Total|Total of all reporting groups
423472|NCT00541970|B4|Baseline|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423666|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
423667|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
423473|NCT00541970|B3|Baseline|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423474|NCT00541970|B2|Baseline|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423475|NCT00541970|B1|Baseline|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423476|NCT00541970|P4|Participant Flow|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423477|NCT00541970|P3|Participant Flow|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423478|NCT00541970|P2|Participant Flow|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423479|NCT00541970|P1|Participant Flow|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423480|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423481|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423482|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423483|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423484|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423485|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423486|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423487|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423488|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423489|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423490|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423491|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423492|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423493|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423494|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423495|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423496|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423497|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423668|NCT00543296|E1|Reported Event|0.59 mg Fluocinolone Acetonide Implant|
423669|NCT00543543|B5|Baseline|Total|Total of all reporting groups
423498|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423499|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423500|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423501|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423502|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423503|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423504|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423505|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423506|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423507|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423508|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423509|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423510|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423511|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423512|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423513|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423514|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423515|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423516|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423517|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423518|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423519|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423520|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423521|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423522|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423670|NCT00543543|B4|Baseline|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423523|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423524|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423525|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423526|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423527|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423528|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423529|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423530|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423531|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423532|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423533|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423534|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423535|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423536|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423537|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423538|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423539|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423540|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423541|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423542|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423543|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423544|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423545|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423546|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423547|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423548|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423549|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423550|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423551|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423552|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423553|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423554|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423555|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423556|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423557|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423558|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423559|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423560|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423561|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423562|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423563|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423564|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423565|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423566|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423567|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423568|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423569|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423570|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423571|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423572|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423573|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423671|NCT00543543|B3|Baseline|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
439633|NCT00577135|O4|Outcome|High Intensification|
423574|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423575|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423576|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423577|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423578|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423579|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423580|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423581|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423582|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423583|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423584|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423585|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423586|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423587|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423588|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423589|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423590|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423591|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423592|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423593|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423594|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423595|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423596|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423597|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423598|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423672|NCT00543543|B2|Baseline|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423599|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423600|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423601|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423602|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423603|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423604|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423605|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423606|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423607|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423608|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423609|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423610|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423611|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423612|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423613|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423614|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423615|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423616|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423617|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423618|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423619|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423620|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423621|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423622|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423623|NCT00541970|E4|Reported Event|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
423673|NCT00543543|B1|Baseline|Low-dose V503|V503 (9-Valent Human Papillomavirus [HPV] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
439634|NCT00577135|O3|Outcome|Low Intensification|
423624|NCT00541970|E3|Reported Event|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423625|NCT00541970|E2|Reported Event|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423626|NCT00541970|E1|Reported Event|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
423627|NCT00542178|B7|Baseline|Total|Total of all reporting groups
423628|NCT00542178|B6|Baseline|Fibrate Placebo|Blinded placebo + simvastatin 20-40 mg/d
423629|NCT00542178|B5|Baseline|Fibrate|Blinded fenofibrate + simvastatin 20-40 mg/d
423630|NCT00542178|B4|Baseline|Standard BP Control|A strategy of BP treatment for SBP less than 140 mm Hg
423631|NCT00542178|B3|Baseline|Intensive BP Control|A strategy of BP treatment for SBP less than 120 mm Hg
423632|NCT00542178|B2|Baseline|Standard Glycemia Control|A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
423633|NCT00542178|B1|Baseline|Intensive Glycemia Control|A strategy of intensive glycemia treatment to HbA1c less than 6%
423634|NCT00542178|P8|Participant Flow|Standard Glycemia Control & Fibrate Placebo|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d"
423635|NCT00542178|P7|Participant Flow|Intensive Glycemia Control & Fibrate Placebo|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%
Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d"
423636|NCT00542178|P6|Participant Flow|Standard Glycemia Control & Fibrate|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d"
423637|NCT00542178|P5|Participant Flow|Intensive Glycemia Control & Fibrate|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%
Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d"
423638|NCT00542178|P4|Participant Flow|Standard Glycemia Control & Standard Blood Pressure Control|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg"
423639|NCT00542178|P3|Participant Flow|Intensive Glycemia Control & Standard Blood Pressure Control|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%
Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg"
423640|NCT00542178|P2|Participant Flow|Standard Glycemia Control & Intensive Blood Pressure Control|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg"
423641|NCT00542178|P1|Participant Flow|Intensive Glycemia Control & Intensive Blood Pressure Control|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%
Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg"
423642|NCT00542178|O6|Outcome|Placebo + Simvastatin Therapy|Blinded placebo + simvastatin 20-40 mg/d
423643|NCT00542178|O5|Outcome|Fenofibrate + Simvastatin Therapy|Blinded fenofibrate + simvastatin 20-40 mg/d
423644|NCT00542178|O4|Outcome|Standard Blood Pressure Control|Strategy of BP treatment for SBP less than 140 mmHg
423645|NCT00542178|O3|Outcome|Intensive Blood Pressure Control|A strategy of BP treatment for SBP less than 120 mmHg
423646|NCT00542178|O2|Outcome|Standard Glycemia Control|Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
423647|NCT00542178|O1|Outcome|Intensive Glycemia Control|Strategy of intensive glycemia treatment to HbA1c less than 6%
423648|NCT00542178|E6|Reported Event|Fibrate Placebo|Blinded placebo + simvastatin 20-40 mg/d
423649|NCT00542178|E5|Reported Event|Fibrate|Blinded fenofibrate + simvastatin 20-40 mg/d
423650|NCT00542178|E4|Reported Event|Standard BP Control|A strategy of BP treatment for SBP less than 140 mm Hg
423651|NCT00542178|E3|Reported Event|Intensive BP Control|A strategy of BP treatment for SBP less than 120 mm Hg
423652|NCT00542178|E2|Reported Event|Standard Glycemia Control|A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
423653|NCT00542178|E1|Reported Event|Intensive Glycemia Control|A strategy of intensive glycemia treatment to HbA1c less than 6%
423654|NCT00543140|B1|Baseline|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
423655|NCT00543140|P1|Participant Flow|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
423656|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
423657|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
423658|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
423659|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
423660|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
423661|NCT00543140|E1|Reported Event|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.
Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
423662|NCT00543296|B1|Baseline|0.59 mg Fluocinolone Acetonide Implant|
423674|NCT00543543|P4|Participant Flow|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423675|NCT00543543|P3|Participant Flow|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
423676|NCT00543543|P2|Participant Flow|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423677|NCT00543543|P1|Participant Flow|Low-dose V503|V503 (9-Valent Human Papillomavirus [HPV] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
423678|NCT00543543|O1|Outcome|Extension Study: Mid-dose V503 (Cohort 1)|V503 mid-dose 0.5 mL injection in a 3-dose regimen in the Base Study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423679|NCT00543543|O1|Outcome|Extension Study: Mid-dose V503 (Cohort 1)|V503 mid-dose 0.5 mL injection in a 3-dose regimen in the Base Study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423680|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423681|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423682|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423683|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423684|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423685|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
423686|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423687|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
423688|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423689|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
423690|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423691|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
423692|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423693|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
423694|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423695|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
423696|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423697|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
423698|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423699|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
423700|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423701|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
423702|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423703|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
423704|NCT00543543|O1|Outcome|Extension Study: Mid-dose V503 (Cohort 1)|V503 mid-dose 0.5 mL injection in a 3-dose regimen in the Base Study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423705|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423706|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423707|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423852|NCT00543764|B2|Baseline|Post Pathway|Patients after pathway implementation
423853|NCT00543764|B1|Baseline|Pre Pathway|Patients prior to pathway implementation
423708|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423709|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
423710|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
423711|NCT00543543|E6|Reported Event|Extension Study: Mid-dose V503 (Cohort 2)|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL 3-dose regimen administration on Base Study participants who were randomized to receive a 3-dose regimen of Gardasil (4-Valent HPV Vaccine) (Cohort 2).
423712|NCT00543543|E5|Reported Event|Extension Study: Mid-dose V503 (Cohort 1)|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL fourth dose administration in Base Study participants who were randomized to receive a 3-dose regimen of V503 (9-Valent HPV) mid-dose 0.5 mL (Cohort 1).
423713|NCT00543543|E4|Reported Event|Base Study: Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) will be offered the V503 mid-dose 3-dose regimen in the extension study.
423714|NCT00543543|E3|Reported Event|Base Study: High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
423715|NCT00543543|E2|Reported Event|Base Study: Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) will receive a fourth V503 mid-dose vaccination in the extension study.
423716|NCT00543543|E1|Reported Event|Base Study: Low-Dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
423717|NCT00543569|B5|Baseline|Total|Total of all reporting groups
423718|NCT00543569|B4|Baseline|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423719|NCT00543569|B3|Baseline|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423720|NCT00543569|B2|Baseline|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423721|NCT00543569|B1|Baseline|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423722|NCT00543569|P4|Participant Flow|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423723|NCT00543569|P3|Participant Flow|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423724|NCT00543569|P2|Participant Flow|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423725|NCT00543569|P1|Participant Flow|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423726|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423727|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423728|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423729|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423730|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423854|NCT00543764|P2|Participant Flow|Post Pathway|Patients after pathway implementation
423855|NCT00543764|P1|Participant Flow|Pre Pathway|Patients prior to pathway implementation
439635|NCT00577135|O2|Outcome|Continuous Infusion|
423731|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423732|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423733|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423734|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423735|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423736|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423737|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423738|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423739|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423740|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423741|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423742|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423743|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423744|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423745|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423746|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423747|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423748|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423749|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423807|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423750|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423751|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423752|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423753|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423754|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423755|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423756|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423757|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423758|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423759|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423760|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423761|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423762|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423763|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423764|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423765|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423766|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423767|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423768|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423834|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
423835|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
423836|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
423837|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
423769|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423770|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423771|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423772|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423773|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423774|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423775|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423776|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423777|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423778|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423779|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423780|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423781|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423782|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423783|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423784|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423785|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423786|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423787|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423838|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
423839|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
423840|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
423841|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
423788|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423789|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423790|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423791|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423792|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423793|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423794|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423795|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423796|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423797|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423798|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423799|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423800|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423801|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423802|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423803|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423804|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423805|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423806|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423842|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
423843|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
423844|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
423845|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
423808|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423809|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423810|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423811|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423812|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423813|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423814|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423815|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423816|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423817|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423818|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423819|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423820|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423821|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423822|NCT00543569|E4|Reported Event|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
423823|NCT00543569|E3|Reported Event|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
423824|NCT00543569|E2|Reported Event|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
423825|NCT00543569|E1|Reported Event|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
423826|NCT00543725|B3|Baseline|Total|Total of all reporting groups
423827|NCT00543725|B2|Baseline|Efavirenz|600 mg once daily
423828|NCT00543725|B1|Baseline|TMC278|25 mg tablet once daily
423829|NCT00543725|P2|Participant Flow|Efavirenz|600 mg once daily
423830|NCT00543725|P1|Participant Flow|TMC278|25 mg tablet once daily
423831|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
423832|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
423833|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
423856|NCT00543764|O2|Outcome|Post Pathway|Patients after pathway implementation
423857|NCT00543764|O1|Outcome|Pre Pathway|Patients prior to pathway implementation
423858|NCT00543764|E2|Reported Event|Post Pathway|Patients after pathway implementation
423859|NCT00543764|E1|Reported Event|Pre Pathway|Patients prior to pathway implementation
423860|NCT00543803|B1|Baseline|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423861|NCT00543803|P1|Participant Flow|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423862|NCT00543803|O2|Outcome|Last Evaluation Assessment on Treatment|Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
423863|NCT00543803|O1|Outcome|Evaluation Assessment at Baseline|Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at baseline)
423864|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423865|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423866|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423867|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423868|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423869|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423870|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423871|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423872|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423873|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423874|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423875|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
423876|NCT00543803|E1|Reported Event|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg OD for two weeks, then 200 mg BID, Truvada one tablet QD
423877|NCT00543855|B5|Baseline|Total|Total of all reporting groups
423878|NCT00543855|B4|Baseline|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423879|NCT00543855|B3|Baseline|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
423880|NCT00543855|B2|Baseline|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
423881|NCT00543855|B1|Baseline|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423882|NCT00543855|P4|Participant Flow|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423883|NCT00543855|P3|Participant Flow|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks)."
423884|NCT00543855|P2|Participant Flow|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
423968|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 with concurrent radiotherapy
423969|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
423885|NCT00543855|P1|Participant Flow|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423886|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423887|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
423888|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
423889|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423890|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423891|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
423892|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
423893|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423894|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423895|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
423896|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
423897|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423898|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423899|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
423900|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
423901|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423902|NCT00543855|E4|Reported Event|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423903|NCT00543855|E3|Reported Event|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
423904|NCT00543855|E2|Reported Event|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
423905|NCT00543855|E1|Reported Event|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
423906|NCT00543985|B1|Baseline|Stress Echocardiography|Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' and VO2 max.
423907|NCT00543985|P1|Participant Flow|Stress Echocardiography|Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
423908|NCT00543985|O1|Outcome|Stress Echocardiography|Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
423909|NCT00543985|O1|Outcome|Stress Echocardiography|"Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
Stress Echocardiography: Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol."
423910|NCT00543985|O1|Outcome|Stress Echocardiography|Echocardiogram E/E' measured after exercise
423911|NCT00543985|O1|Outcome|Stress Echocardiography|Echocardiogram E/E' measured before and after exercise
423912|NCT00543985|E1|Reported Event|Stress Echocardiography|Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' .
423913|NCT00544167|B1|Baseline|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|Doxorubicin 60mg/m2 IV, Cyclophosphamide 600mg/m2 IV every 3 weeks for a total of 12 weeks followed by 12 weeks of paclitaxel (either 175mg/m2 IV every three weeks or 80mg/m2 IV weekly) and sorafenib 400mg twice daily by mouth (up to a maximum of 1 year).
423914|NCT00544167|P1|Participant Flow|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
423915|NCT00544167|O1|Outcome|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|
423916|NCT00544167|E1|Reported Event|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
423917|NCT00544440|B1|Baseline|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
423918|NCT00544440|P1|Participant Flow|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
423919|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
423920|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
423921|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
423922|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
423923|NCT00544440|E1|Reported Event|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
423924|NCT00544544|B1|Baseline|Riluzole|Riluzole 100-200 mg/day
423925|NCT00544544|P1|Participant Flow|Riluzole|Riluzole 100-200 mg/day
423926|NCT00544544|O1|Outcome|Riluzole|Riluzole 100-200 mg/day
423927|NCT00544544|E1|Reported Event|Riluzole|Riluzole 100-200 mg/day
423928|NCT00544557|B1|Baseline|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423929|NCT00544557|P1|Participant Flow|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423930|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423931|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423932|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423933|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423934|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423935|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423936|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423937|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423938|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423939|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423940|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423941|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423942|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423943|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423944|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423945|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423946|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423947|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423970|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
424130|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
423948|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423949|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423950|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423951|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423952|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423953|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423954|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423955|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423956|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423957|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423958|NCT00544557|E1|Reported Event|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
423959|NCT00544648|B3|Baseline|Total|Total of all reporting groups
423960|NCT00544648|B2|Baseline|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
423961|NCT00544648|B1|Baseline|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
423962|NCT00544648|P2|Participant Flow|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
423963|NCT00544648|P1|Participant Flow|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
423964|NCT00544648|O1|Outcome|Phase I and Phase II|"Phase I-Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
Phase II-MTD Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
Phase II-"
423965|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
423966|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
423967|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
423971|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
423972|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
423973|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
423974|NCT00544648|E2|Reported Event|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
423975|NCT00544648|E1|Reported Event|Phase I|Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
423976|NCT00544674|B1|Baseline|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
423977|NCT00544674|P1|Participant Flow|PR104|Subjects will receive 1100 mg/m^2 PR-104 intravenously once every 21 days (one cycle). In addition, subjects will undergo positron emission topography (PET) imaging with F-18-Fluoro Misonidazole (FMISO) for the assessment of hypoxia and with F-18-Fluorodeoxyglucose (FDG) for the assessment of glucose metabolism.
423978|NCT00544674|O1|Outcome|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
423979|NCT00544674|E1|Reported Event|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
423980|NCT00544713|B3|Baseline|Total|Total of all reporting groups
423981|NCT00544713|B2|Baseline|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
423982|NCT00544713|B1|Baseline|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
423983|NCT00544713|P2|Participant Flow|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
423984|NCT00544713|P1|Participant Flow|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
423985|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
423986|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
423987|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
423988|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
423989|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
423990|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
423991|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
423992|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
423993|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
423994|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
423995|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
423996|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
423997|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
423998|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
423999|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
424000|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
424001|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
424002|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
424003|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
424004|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
424005|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
424006|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
424007|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
424008|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
424009|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
424010|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
424011|NCT00544713|E2|Reported Event|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
424012|NCT00544713|E1|Reported Event|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
424013|NCT00544778|B1|Baseline|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
424122|NCT00545103|P3|Participant Flow|SPD476 (4.8 g)|4.8 g administered orally once daily
424014|NCT00544778|P1|Participant Flow|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
424015|NCT00544778|O1|Outcome|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
424016|NCT00544778|E1|Reported Event|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
424017|NCT00544817|B1|Baseline|Combination Therapy|"In the combined modality portion of the study, patients were administered:
Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily
Patients took a four week break before beginning follow-up systemic therapy:
Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
424018|NCT00544817|P1|Participant Flow|Combination Therapy|"In the combined modality portion of the study, patients were administered:
Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily
Patients took a four week break before beginning follow-up systemic therapy:
Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
424019|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:
Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily
Patients took a four week break before beginning follow-up systemic therapy:
Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
424020|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:
Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily
Patients took a four week break before beginning follow-up systemic therapy:
Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
424021|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:
Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily
Patients took a four week break before beginning follow-up systemic therapy:
Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
424022|NCT00544817|E1|Reported Event|Combination Therapy|"In the combined modality portion of the study, patients were administered:
Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily
Patients took a four week break before beginning follow-up systemic therapy:
Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
424023|NCT00544869|B4|Baseline|Total|Total of all reporting groups
424024|NCT00544869|B3|Baseline|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
424025|NCT00544869|B2|Baseline|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
424026|NCT00544869|B1|Baseline|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
424027|NCT00544869|P3|Participant Flow|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
424028|NCT00544869|P2|Participant Flow|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
424029|NCT00544869|P1|Participant Flow|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
424030|NCT00544869|O3|Outcome|Dose Escalated to 30 mg/Day|
424031|NCT00544869|O2|Outcome|Continued at 15 mg/Day|
424032|NCT00544869|O1|Outcome|Stopped at End of Treatment Period 1|
424033|NCT00544869|E3|Reported Event|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
424034|NCT00544869|E2|Reported Event|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
424035|NCT00544869|E1|Reported Event|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
424036|NCT00544882|B3|Baseline|Total|Total of all reporting groups
424037|NCT00544882|B2|Baseline|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424038|NCT00544882|B1|Baseline|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424039|NCT00544882|P3|Participant Flow|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424040|NCT00544882|P2|Participant Flow|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424041|NCT00544882|P1|Participant Flow|Run-In Cycle - All Enrolled|After completing screening, all enrolled participants received the same regimen of 150 μg Desogestrel (DSG) /20 μg Ethinyl Estradiol (EE) combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1.
424042|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424043|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424044|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424045|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424046|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424047|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424048|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424049|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424050|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424051|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424052|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424053|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424123|NCT00545103|P2|Participant Flow|SPD476 (2.4 g)|2.4 g administered orally once daily
424124|NCT00545103|P1|Participant Flow|SPD476 (1.2 g)|1.2 g administered orally once daily
424125|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
424054|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424055|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424056|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424057|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424058|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424059|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424060|NCT00544882|E2|Reported Event|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424061|NCT00544882|E1|Reported Event|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
424062|NCT00544908|B1|Baseline|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
424063|NCT00544908|P1|Participant Flow|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
424064|NCT00544908|O1|Outcome|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
424065|NCT00544908|O1|Outcome|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
424066|NCT00544908|E1|Reported Event|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
424067|NCT00545025|B3|Baseline|Total|Total of all reporting groups
424068|NCT00545025|B2|Baseline|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
424069|NCT00545025|B1|Baseline|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
424070|NCT00545025|P2|Participant Flow|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
424071|NCT00545025|P1|Participant Flow|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
424126|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424127|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424128|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424072|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
424073|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
424074|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
424075|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
424076|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
424077|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
424078|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
424079|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
424080|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
424081|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
424082|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
424083|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
424084|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
424085|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
424086|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
424129|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
424087|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
424088|NCT00545025|E2|Reported Event|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
424089|NCT00545025|E1|Reported Event|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine adjuvanted with a full dose of AS03-adjuvant in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03- adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
424090|NCT00545051|B3|Baseline|Total|Total of all reporting groups
424091|NCT00545051|B2|Baseline|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424092|NCT00545051|B1|Baseline|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424093|NCT00545051|P2|Participant Flow|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424094|NCT00545051|P1|Participant Flow|Ibandronate|Participants received 150 milligram (mg) ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 International Units (IU) Vitamin D per day.
424095|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424096|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424097|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424098|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424099|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424100|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424101|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424102|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424103|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424104|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424105|NCT00545051|E2|Reported Event|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424106|NCT00545051|E1|Reported Event|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
424107|NCT00545064|B1|Baseline|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily
The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
424108|NCT00545064|P1|Participant Flow|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily
The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
424109|NCT00545064|O2|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 8|
424110|NCT00545064|O1|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 4|
424111|NCT00545064|O1|Outcome|Preservative-free COSOPT® at Week 8|
424112|NCT00545064|O1|Outcome|Preservative-free COSOPT® at Week 8|
424113|NCT00545064|O2|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 8|
424114|NCT00545064|O1|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 4|
424115|NCT00545064|E1|Reported Event|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily
The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
424116|NCT00545103|B5|Baseline|Total|Total of all reporting groups
424117|NCT00545103|B4|Baseline|Placebo|Placebo administered orally once daily
424118|NCT00545103|B3|Baseline|SPD476 (4.8 g)|4.8 g administered orally once daily
424119|NCT00545103|B2|Baseline|SPD476 (2.4 g)|2.4 g administered orally once daily
424120|NCT00545103|B1|Baseline|SPD476 (1.2 g)|1.2 g administered orally once daily
424121|NCT00545103|P4|Participant Flow|Placebo|Placebo administered orally once daily
424131|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424132|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424133|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
424134|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424135|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424136|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424137|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
424138|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424139|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424140|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424141|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
424142|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424143|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424144|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424145|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
424146|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424147|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424148|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424149|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
424150|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424151|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424152|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424153|NCT00545103|E4|Reported Event|Placebo|Placebo administered orally once daily
424154|NCT00545103|E3|Reported Event|SPD476 (4.8 g)|4.8 g administered orally once daily
424155|NCT00545103|E2|Reported Event|SPD476 (2.4 g)|2.4 g administered orally once daily
424156|NCT00545103|E1|Reported Event|SPD476 (1.2 g)|1.2 g administered orally once daily
424157|NCT00545155|B1|Baseline|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424158|NCT00545155|P1|Participant Flow|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424159|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424160|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424161|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424162|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424163|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424164|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424165|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424166|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424167|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424168|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424169|NCT00545155|E1|Reported Event|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
424170|NCT00545168|B4|Baseline|Total|Total of all reporting groups
424171|NCT00545168|B3|Baseline|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
424172|NCT00545168|B2|Baseline|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
424173|NCT00545168|B1|Baseline|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
424174|NCT00545168|P3|Participant Flow|C - NIX|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
424175|NCT00545168|P2|Participant Flow|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
424176|NCT00545168|P1|Participant Flow|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
424177|NCT00545168|O3|Outcome|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
424178|NCT00545168|O2|Outcome|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
424179|NCT00545168|O1|Outcome|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
424180|NCT00545168|O2|Outcome|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
424181|NCT00545168|O1|Outcome|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
424182|NCT00545168|E2|Reported Event|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
424183|NCT00545168|E1|Reported Event|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
424184|NCT00545181|B3|Baseline|Total|Total of all reporting groups
424185|NCT00545181|B2|Baseline|Metronidazole Alone|Metronidazole antibiotic therapy alone
424186|NCT00545181|B1|Baseline|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
424187|NCT00545181|P2|Participant Flow|Metronidazole Alone|Metronidazole antibiotic therapy alone
424188|NCT00545181|P1|Participant Flow|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
424189|NCT00545181|O2|Outcome|Metronidazole Alone|Metronidazole antibiotic therapy alone
424190|NCT00545181|O1|Outcome|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
424191|NCT00545181|E2|Reported Event|Metronidazole Alone|Metronidazole antibiotic therapy alone
424192|NCT00545181|E1|Reported Event|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
424194|NCT00545233|B2|Baseline|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424195|NCT00545233|B1|Baseline|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424196|NCT00545233|P2|Participant Flow|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424197|NCT00545233|P1|Participant Flow|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424198|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424199|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424200|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424201|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424202|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424203|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424204|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424205|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424206|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424207|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424261|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424208|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424209|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424210|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424211|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424212|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424213|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424214|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424215|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424216|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424217|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424218|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424219|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424220|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424221|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424262|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424222|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424223|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424224|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424225|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424226|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received piogliatzone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of piogliatzone per day orally in the 24 week follow-up period.
424227|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424228|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424229|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424230|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424231|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424232|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424233|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424234|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424235|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424263|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
424236|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424237|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424238|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424239|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424240|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424241|NCT00545233|E2|Reported Event|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
424242|NCT00545233|E1|Reported Event|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
424243|NCT00545272|B7|Baseline|Total|Total of all reporting groups
424244|NCT00545272|B6|Baseline|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424245|NCT00545272|B5|Baseline|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
424246|NCT00545272|B4|Baseline|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424247|NCT00545272|B3|Baseline|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424248|NCT00545272|B2|Baseline|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424249|NCT00545272|B1|Baseline|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424250|NCT00545272|P6|Participant Flow|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424251|NCT00545272|P5|Participant Flow|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
424252|NCT00545272|P4|Participant Flow|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424253|NCT00545272|P3|Participant Flow|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424254|NCT00545272|P2|Participant Flow|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424255|NCT00545272|P1|Participant Flow|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424256|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424257|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
424258|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424259|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424260|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
439636|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
424264|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424265|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424266|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424267|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424268|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424269|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
424270|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424271|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424272|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424273|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424274|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424275|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
424276|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424277|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424278|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424279|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424280|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424281|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
424282|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424283|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424284|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424285|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424286|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424287|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
424288|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424289|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424290|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424291|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424292|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424293|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
424294|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424295|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424296|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424297|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424298|NCT00545272|E6|Reported Event|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424299|NCT00545272|E5|Reported Event|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
424300|NCT00545272|E4|Reported Event|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424301|NCT00545272|E3|Reported Event|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424302|NCT00545272|E2|Reported Event|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424303|NCT00545272|E1|Reported Event|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
424304|NCT00545298|B4|Baseline|Total|Total of all reporting groups
424305|NCT00545298|B3|Baseline|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
424306|NCT00545298|B2|Baseline|B Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
424307|NCT00545298|B1|Baseline|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
424308|NCT00545298|P3|Participant Flow|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
424309|NCT00545298|P2|Participant Flow|B - Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
424310|NCT00545298|P1|Participant Flow|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
424311|NCT00545298|O3|Outcome|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
424312|NCT00545298|O2|Outcome|B - Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
424313|NCT00545298|O1|Outcome|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
424314|NCT00545298|O3|Outcome|C - Modified Treatment, 5 Wks Lower Dose|200 ppm NO gas 8 hrs / day 1 wk, 20ppm 8 hrs / day 5 weeks. Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
424315|NCT00545298|O2|Outcome|A - Standard of Care (Control)|Standard of Care - dressings and sustained compression only
424316|NCT00545298|O1|Outcome|B - Same Treatment for 6 Weeks|This group received 200ppm NO in Nitrogen delivered constantly to a patch over the wound for 8 hours per day for 6 weeks
424317|NCT00545298|E3|Reported Event|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
424318|NCT00545298|E2|Reported Event|B Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
424319|NCT00545298|E1|Reported Event|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
424320|NCT00545363|B3|Baseline|Total|Total of all reporting groups
424321|NCT00545363|B2|Baseline|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
424322|NCT00545363|B1|Baseline|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
424323|NCT00545363|P2|Participant Flow|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
424324|NCT00545363|P1|Participant Flow|Bone Marker Feedback (BMF) Participants|"Postmenopausal women received ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants, in this arm, received bone marker feedback (BMF) at Month 3. BMF was given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by patient relationship program (PRP), carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
424325|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
424326|NCT00545363|O1|Outcome|BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A “BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
424327|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
424328|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
424880|NCT00546273|B5|Baseline|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
424329|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
424330|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
424331|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
424332|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
424333|NCT00545363|E2|Reported Event|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
424334|NCT00545363|E1|Reported Event|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
424335|NCT00545402|B3|Baseline|Total|Total of all reporting groups
424336|NCT00545402|B2|Baseline|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
424337|NCT00545402|B1|Baseline|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
424338|NCT00545402|P2|Participant Flow|Fixed-Dose MMF + Tacrolimus + Corticosteroid (CS)|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
424339|NCT00545402|P1|Participant Flow|Adjusted Mycophenolate Mofetil (MMF)+Tacrolimus+Corticosteroid|Participants received MMF tablets or capsules, 3 grams per day (g/d), orally (PO), twice daily (BID) with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (area under the concentration-time curve [AUC]) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 nanograms per milliliter (ng/mL) from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an intravenous (IV) bolus of methylprednisolone 10-15 milligrams per kilogram (mg/kg) pre-operative on Day 0 per standard practice of the center.
424340|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
424341|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
424376|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424342|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
424343|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
424344|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
424345|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
424346|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
424347|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
424348|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
424349|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
424350|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
424351|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
424352|NCT00545402|E2|Reported Event|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
424353|NCT00545402|E1|Reported Event|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
424354|NCT00545441|B3|Baseline|Total|Total of all reporting groups
424355|NCT00545441|B2|Baseline|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
424356|NCT00545441|B1|Baseline|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
424357|NCT00545441|P2|Participant Flow|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
424358|NCT00545441|P1|Participant Flow|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
424359|NCT00545441|O2|Outcome|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
424360|NCT00545441|O1|Outcome|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
424361|NCT00545441|E2|Reported Event|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
424362|NCT00545441|E1|Reported Event|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
424363|NCT00545506|B3|Baseline|Total|Total of all reporting groups
424364|NCT00545506|B2|Baseline|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
424365|NCT00545506|B1|Baseline|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
424366|NCT00545506|P2|Participant Flow|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
424367|NCT00545506|P1|Participant Flow|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
424368|NCT00545506|O2|Outcome|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
424369|NCT00545506|O1|Outcome|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
424370|NCT00545506|E2|Reported Event|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
424371|NCT00545506|E1|Reported Event|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
424372|NCT00545571|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424373|NCT00545571|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week dose titration period (DTP) to maintain hemoglobin (Hb) concentrations within a country-specific target: 11.0 to 13.0 grams per deciliter (g/dL) in Switzerland and 10.0 to 12.0 g/dL in Austria.
424374|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424375|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424446|NCT00533273|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
424377|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424378|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424379|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424380|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424381|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424382|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424383|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424384|NCT00545571|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
424385|NCT00545584|B4|Baseline|Total|Total of all reporting groups
424386|NCT00545584|B3|Baseline|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
424387|NCT00545584|B2|Baseline|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet which includes advice on diet with a leaflet and a diary"
424388|NCT00545584|B1|Baseline|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
No specific intervention (standard recommendation) on physical exercise and diet."
424389|NCT00545584|P3|Participant Flow|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
424390|NCT00545584|P2|Participant Flow|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet which includes advice on diet with a leaflet and a diary"
424391|NCT00545584|P1|Participant Flow|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
No specific intervention (standard recommendation) on physical exercise and diet."
424392|NCT00545584|O3|Outcome|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
424393|NCT00545584|O2|Outcome|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet which includes advice on diet with a leaflet and a diary"
424394|NCT00545584|O1|Outcome|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
No specific intervention (standard recommendation) on physical exercise and diet."
424395|NCT00545584|O3|Outcome|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
424447|NCT00533273|O2|Outcome|Placebo|Placebo injection is comprised of sucrose and Tris
424396|NCT00545584|O2|Outcome|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet which includes advice on diet with a leaflet and a diary"
424397|NCT00545584|O1|Outcome|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
No specific intervention (standard recommendation) on physical exercise and diet."
424398|NCT00545584|E3|Reported Event|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
424399|NCT00545584|E2|Reported Event|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet which includes advice on diet with a leaflet and a diary"
424400|NCT00545584|E1|Reported Event|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
No specific intervention (standard recommendation) on physical exercise and diet."
424401|NCT00545623|B5|Baseline|Total|Total of all reporting groups
424402|NCT00545623|B4|Baseline|SHAM+EDU|"sham acupuncture+education CD
sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
424403|NCT00545623|B3|Baseline|ACUP+EDU|"acupuncture+education CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
424404|NCT00545623|B2|Baseline|SHAM+RR|"sham acupuncture + relaxation response CD
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
424405|NCT00545623|B1|Baseline|ACUP+RR|"acupuncture + relaxation response CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
424406|NCT00545623|P4|Participant Flow|SHAM+EDU|"sham acupuncture+education CD
sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
424407|NCT00545623|P3|Participant Flow|ACUP+EDU|"acupuncture+education CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
424408|NCT00545623|P2|Participant Flow|SHAM+RR|"sham acupuncture + relaxation response CD
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
424409|NCT00545623|P1|Participant Flow|ACUP+RR|"acupuncture + relaxation response CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
424410|NCT00545623|O4|Outcome|SHAM+EDU|"sham acupuncture+education CD
sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
424411|NCT00545623|O3|Outcome|ACUP+EDU|"acupuncture+education CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
424412|NCT00545623|O2|Outcome|SHAM+RR|"sham acupuncture + relaxation response CD
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
424413|NCT00545623|O1|Outcome|ACUP+RR|"acupuncture + relaxation response CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
424414|NCT00545623|E4|Reported Event|SHAM+EDU|"sham acupuncture+education CD
sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
424415|NCT00545623|E3|Reported Event|ACUP+EDU|"acupuncture+education CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
424416|NCT00545623|E2|Reported Event|SHAM+RR|"sham acupuncture + relaxation response CD
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
424417|NCT00545623|E1|Reported Event|ACUP+RR|"acupuncture + relaxation response CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
424418|NCT00545662|B3|Baseline|Total|Total of all reporting groups
424419|NCT00545662|B2|Baseline|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
424420|NCT00545662|B1|Baseline|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
424421|NCT00545662|P2|Participant Flow|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
424422|NCT00545662|P1|Participant Flow|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
424423|NCT00545662|O2|Outcome|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
424424|NCT00545662|O1|Outcome|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
424425|NCT00545662|E2|Reported Event|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
424426|NCT00545662|E1|Reported Event|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
424427|NCT00533117|B5|Baseline|Total|Total of all reporting groups
424428|NCT00533117|B4|Baseline|Supportive Therapy Placebo|"Supportive psychotherapy and placebo See above for descriptions.
Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
424429|NCT00533117|B3|Baseline|Supportive Therapy Fluoxetine|"Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
424430|NCT00533117|B2|Baseline|Dialectical Behavior Therapy Placebo|"Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
424431|NCT00533117|B1|Baseline|Dialectical Behavior Therapy Fluoxetine|"Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
424432|NCT00533117|P4|Participant Flow|Supportive Therapy Placebo|"Supportive psychotherapy and placebo See above for descriptions.
Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
424433|NCT00533117|P3|Participant Flow|Supportive Therapy Fluoxetine|"Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
424434|NCT00533117|P2|Participant Flow|DBT Placebo|"Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
424435|NCT00533117|P1|Participant Flow|DBT Fluoxetine|"Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
424436|NCT00533117|O2|Outcome|Supportive Therapy With or Without Fluoxetine|Participants received 12 months of ST and either Fluoxetine or placebo medication with weekly medication visits (double blind)
424437|NCT00533117|O1|Outcome|Dialectical Behavior Therapy With or Without Fluoxetine|Participants received 12 months of DBT and either Fluoxetine or placebo medication with weekly medication visits (double blind)
424438|NCT00533117|E4|Reported Event|Supportive Therapy With Placebo|Participants received 12 months of supportive therapy with placebo weekly medication management sessions(double blind). This condition served as the control condition. Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups.Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo.
424439|NCT00533117|E3|Reported Event|Dialectical Behavior Therapy With Placebo|Participants received 12 months of DBT therapy with placebo medication with weekly medication management sessions (double blind). Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups.Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo.
424440|NCT00533117|E2|Reported Event|Supportive Therapy With Fluoxetine|Participants received 12 months of supportive therapy with fluoxetine weekly medication management sessions(double blind). Planned analyses were with supportive therapy/placebo. Also, fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups. Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo.
424441|NCT00533117|E1|Reported Event|Dialectical Behavior Therapy With Fluoxetine|Participants received 12 months of DBT therapy with fluoxetine with weekly medication management sessions (double blind). Primary planned analyses were with supportive therapy/placebo. Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups. Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo.
424442|NCT00533273|B3|Baseline|Total|Total of all reporting groups
424443|NCT00533273|B2|Baseline|Placebo|Placebo (Sucrose and Tris)
424444|NCT00533273|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
424445|NCT00533273|P2|Participant Flow|Placebo|Placebo for injection was comprised of sucrose and Tris
424448|NCT00533273|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
424449|NCT00533273|E2|Reported Event|Placebo|Placebo injection is comprised of sucrose and Tris
424450|NCT00533273|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
424451|NCT00533351|B3|Baseline|Total|Total of all reporting groups
424452|NCT00533351|B2|Baseline|Placebo Followed by AGN201781|
424453|NCT00533351|B1|Baseline|AGN201781 Followed by Placebo|
424454|NCT00533351|P2|Participant Flow|Placebo Followed by AGN201781|
424455|NCT00533351|P1|Participant Flow|AGN201781 Followed by Placebo|
424456|NCT00533351|O2|Outcome|Placebo|
424457|NCT00533351|O1|Outcome|AGN201781|
424458|NCT00533351|O2|Outcome|Placebo|
424459|NCT00533351|O1|Outcome|AGN201781|
424460|NCT00533351|E2|Reported Event|Placebo Followed by AGN201781|
424461|NCT00533351|E1|Reported Event|AGN201781 Followed by Placebo|
424462|NCT00533442|B3|Baseline|Total|Total of all reporting groups
424463|NCT00533442|B2|Baseline|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.
Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:
10-15ng/ml)
Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
424464|NCT00533442|B1|Baseline|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.
Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
424465|NCT00533442|P2|Participant Flow|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.
Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:
10-15ng/ml)
Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
424466|NCT00533442|P1|Participant Flow|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.
Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
424467|NCT00533442|O2|Outcome|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.
Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:
10-15ng/ml)
Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
424468|NCT00533442|O1|Outcome|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.
Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
424469|NCT00533442|O2|Outcome|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.
Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
424470|NCT00533442|O1|Outcome|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.
Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:
10-15ng/ml)
Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
424471|NCT00533442|O2|Outcome|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.
Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:
10-15ng/ml)
Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
424472|NCT00533442|O1|Outcome|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.
Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
424473|NCT00533442|E2|Reported Event|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.
Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:
10-15ng/ml)
Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
424474|NCT00533442|E1|Reported Event|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.
Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
424475|NCT00533507|B1|Baseline|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424476|NCT00533507|P1|Participant Flow|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
439637|NCT00577135|O4|Outcome|High Intensification|
424477|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424478|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424479|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424480|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424481|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424482|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424483|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424484|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424485|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424486|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424487|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424488|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424489|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424490|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424491|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424492|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424493|NCT00533507|E1|Reported Event|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
424494|NCT00533546|B1|Baseline|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.
Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
424495|NCT00533546|P1|Participant Flow|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.
Activated Protein C : Intravenous APC (10 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
424496|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.
Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
424497|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.
Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
424498|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.
Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
424499|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.
Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
424500|NCT00533546|E1|Reported Event|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.
Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
424501|NCT00539032|B3|Baseline|Total|Total of all reporting groups
424502|NCT00539032|B2|Baseline|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
424503|NCT00539032|B1|Baseline|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
424504|NCT00539032|P2|Participant Flow|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
424505|NCT00539032|P1|Participant Flow|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
424506|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
424507|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
424508|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
424509|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
424510|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
424511|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
424512|NCT00539032|E2|Reported Event|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
424513|NCT00539032|E1|Reported Event|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
424514|NCT00539110|B3|Baseline|Total|Total of all reporting groups
424515|NCT00539110|B2|Baseline|Ramelteon First, Then Zolpidem|dosed at 2200 and 0200 per the feeding tube
424516|NCT00539110|B1|Baseline|Zolpidem First, Then Ramelteon|dosed at 2200 and 0200 per the feeding tube
424517|NCT00539110|P2|Participant Flow|Ramelteon, Then Zolpidem|"medication dosed at 2200 and 0200 per the feeding tube
washout with no sleep meds (x3 nights); ramelteon (x4 nights); washout (x3 nights); then zolpidem (x 4 nights)"
424518|NCT00539110|P1|Participant Flow|Zolpidem First, Then Ramelteon|"medication dosed at 2200 and 0200 per feeding tube
washout with no sleep meds (3 nights); zolpidem (x4 nights); washout (x3 nights); then ramelteon (x4 nights)"
424519|NCT00539110|O2|Outcome|Ramelteon|dosed at 2200 and 0200 per the feeding tube
424520|NCT00539110|O1|Outcome|Zolpidem|medication dosed at 2200 and 0200 per feeding tube
424521|NCT00539110|E2|Reported Event|Ramelteon|"dosed at 2200 and 0200 per the feeding tube
ramelteon: medication dosed at 2200 and 0200 per feeding tube"
424522|NCT00539110|E1|Reported Event|Zolpidem|"medication dosed at 2200 and 0200 per feeding tube
zolipidem: dosed at 2200 and 0200 per feeding tube"
424523|NCT00539188|B3|Baseline|Total|Total of all reporting groups
424524|NCT00539188|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
424525|NCT00539188|B1|Baseline|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
424526|NCT00539188|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
424527|NCT00539188|P1|Participant Flow|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
424528|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
424529|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
424530|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
424531|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
424532|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
424533|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
424534|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
424535|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
424536|NCT00539188|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
424705|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424537|NCT00539188|E1|Reported Event|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
424538|NCT00539240|B4|Baseline|Total|Total of all reporting groups
424539|NCT00539240|B3|Baseline|AcipHex 20 mg Once, Placebo Once, Nortriptyline|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
424540|NCT00539240|B2|Baseline|AcipHex 20 mg Once Daily and BID Placebo|"AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
424541|NCT00539240|B1|Baseline|AciPhex 20 mg BID and Once Daily Placebo|"AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
424542|NCT00539240|P3|Participant Flow|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
424543|NCT00539240|P2|Participant Flow|Arm 2|"AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
424544|NCT00539240|P1|Participant Flow|Arm 1|"AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
424545|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
424546|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
424547|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
424548|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
424549|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
424550|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
424551|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
424552|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
424553|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
424554|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
424555|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
424556|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
424557|NCT00539240|E3|Reported Event|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
424558|NCT00539240|E2|Reported Event|Arm 2|"AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
424559|NCT00539240|E1|Reported Event|Arm 1|"AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
424560|NCT00539279|B3|Baseline|Total|Total of all reporting groups
424561|NCT00539279|B2|Baseline|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
424562|NCT00539279|B1|Baseline|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
424563|NCT00539279|P2|Participant Flow|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
424564|NCT00539279|P1|Participant Flow|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
424706|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
424565|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
424566|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
424567|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
424568|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
424569|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
424570|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
424571|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
424572|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
424573|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
424574|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
424575|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
424576|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
424577|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
424578|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
424579|NCT00539279|E2|Reported Event|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
424580|NCT00539279|E1|Reported Event|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
424581|NCT00539305|B3|Baseline|Total|Total of all reporting groups
424582|NCT00539305|B2|Baseline|Placebo Group|Placebo gel : applied topically daily for six months
424583|NCT00539305|B1|Baseline|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl
testosterone gel : 50-100mg applied topically daily for six months"
424584|NCT00539305|P2|Participant Flow|Placebo Group|Placebo gel : applied topically daily for six months
424585|NCT00539305|P1|Participant Flow|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl
testosterone gel : 50-100mg applied topically daily for six months"
424586|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
424587|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl
testosterone gel : 50-100mg applied topically daily for six months"
424588|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
424589|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl
testosterone gel : 50-100mg applied topically daily for six months"
424590|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
424591|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl
testosterone gel : 50-100mg applied topically daily for six months"
424592|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
424593|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl
testosterone gel : 50-100mg applied topically daily for six months"
424594|NCT00539305|E2|Reported Event|Placebo Group|Placebo gel : applied topically daily for six months
424595|NCT00539305|E1|Reported Event|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl
testosterone gel : 50-100mg applied topically daily for six months"
424596|NCT00545688|B5|Baseline|Total|Total of all reporting groups
424597|NCT00545688|B4|Baseline|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424598|NCT00545688|B3|Baseline|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424599|NCT00545688|B2|Baseline|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424600|NCT00545688|B1|Baseline|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424601|NCT00545688|P4|Participant Flow|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424602|NCT00545688|P3|Participant Flow|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424603|NCT00545688|P2|Participant Flow|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424604|NCT00545688|P1|Participant Flow|Trastuzumab + Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab intravenous (IV) infusion at a loading dose of 8 milligrams per kilogram (mg/kg) on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 milligrams per square meter (mg/m^2) on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by 5-fluorouracil 600 mg/m^2 IV, epirubicin 90 mg/m^2 IV, and cyclophosphamide 600 mg/m^2 IV (FEC) on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424605|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424606|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424707|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424607|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424608|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424609|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424610|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424611|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424612|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424613|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424614|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424615|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424616|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424708|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424709|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424710|NCT00545740|E4|Reported Event|Placebo|Placebo administered orally once daily
424617|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424618|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424619|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424620|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424621|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424622|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424623|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424624|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424625|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424626|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424711|NCT00545740|E3|Reported Event|SPD476 (4.8 g)|4.8 g administered orally once daily
424712|NCT00545740|E2|Reported Event|SPD476 (2.4 g)|2.4 g administered orally once daily
424713|NCT00545740|E1|Reported Event|SPD476 (1.2 g)|1.2 g administered orally once daily
424627|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424628|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424629|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424630|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424631|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424632|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424633|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424634|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424635|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424636|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424714|NCT00545753|B4|Baseline|Total|Total of all reporting groups
424715|NCT00545753|B3|Baseline|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
439638|NCT00577135|O3|Outcome|Low Intensification|
424637|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424638|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424639|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424640|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424641|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424642|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424643|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424644|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424645|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424646|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424716|NCT00545753|B2|Baseline|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse - 1% - nit comb regimen required
424717|NCT00545753|B1|Baseline|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse - 1% - no nit combing required
424647|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424648|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424649|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424650|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424651|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424652|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424653|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424654|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424655|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424656|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424718|NCT00545753|P3|Participant Flow|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
424719|NCT00545753|P2|Participant Flow|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required
424657|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424658|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424659|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424660|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424661|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424662|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424663|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424664|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424665|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424666|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424720|NCT00545753|P1|Participant Flow|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
424881|NCT00546273|B4|Baseline|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
424667|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424668|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424669|NCT00545688|E4|Reported Event|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
424670|NCT00545688|E3|Reported Event|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
424671|NCT00545688|E2|Reported Event|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424672|NCT00545688|E1|Reported Event|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.
Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
424673|NCT00545740|B5|Baseline|Total|Total of all reporting groups
424674|NCT00545740|B4|Baseline|Placebo|Placebo administered orally once daily
424675|NCT00545740|B3|Baseline|SPD476 (4.8 g)|4.8 g administered orally once daily
424676|NCT00545740|B2|Baseline|SPD476 (2.4 g)|2.4 g administered orally once daily
424677|NCT00545740|B1|Baseline|SPD476 (1.2 g)|1.2 g administered orally once daily
424678|NCT00545740|P4|Participant Flow|Placebo|Placebo administered orally once daily
424679|NCT00545740|P3|Participant Flow|SPD476 (4.8 g)|4.8 g administered orally once daily
424680|NCT00545740|P2|Participant Flow|SPD476 (2.4 g)|2.4 g administered orally once daily
424681|NCT00545740|P1|Participant Flow|SPD476 (1.2 g)|1.2 g administered orally once daily
424682|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
424683|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424684|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424685|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424686|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
424687|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424688|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424689|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424690|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
424691|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424692|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424693|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424694|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
424695|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424696|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424697|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424698|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
424699|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424700|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424701|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
424702|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
424703|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
424704|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
424721|NCT00545753|O2|Outcome|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
424722|NCT00545753|O1|Outcome|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
424723|NCT00545753|O3|Outcome|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC)Instructions for Use
424724|NCT00545753|O2|Outcome|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required
424725|NCT00545753|O1|Outcome|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
424726|NCT00545753|E2|Reported Event|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
424727|NCT00545753|E1|Reported Event|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse - 1% - With or without nit combing
424728|NCT00545766|B1|Baseline|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
424729|NCT00545766|P1|Participant Flow|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
424730|NCT00545766|O1|Outcome|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
424731|NCT00545766|E1|Reported Event|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
424732|NCT00545779|B1|Baseline|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424733|NCT00545779|P1|Participant Flow|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424734|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424735|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424736|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424737|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424738|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424739|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424740|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424741|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424742|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424743|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424744|NCT00545779|E1|Reported Event|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
424745|NCT00545792|B1|Baseline|Avastin|"Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
424746|NCT00545792|P1|Participant Flow|Avastin|"Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
424747|NCT00545792|O1|Outcome|Avastin|"Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
424748|NCT00545792|O1|Outcome|Avastin|"Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
424749|NCT00545792|E1|Reported Event|Avastin|"Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
424750|NCT00545844|B1|Baseline|All Patients|"montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients."
424794|NCT00546000|E1|Reported Event|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications"
424795|NCT00546078|B3|Baseline|Total|Total of all reporting groups
424751|NCT00545844|P1|Participant Flow|All Patients|"montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients."
424752|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
424753|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
424754|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
424755|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
424756|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
424757|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
424758|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
424759|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
424760|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 8|
424761|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
424762|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
424763|NCT00545844|E1|Reported Event|All Patients|
424764|NCT00545948|B4|Baseline|Total|Total of all reporting groups
424765|NCT00545948|B3|Baseline|Screen Failures|"Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.
Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures."
424766|NCT00545948|B2|Baseline|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
424767|NCT00545948|B1|Baseline|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
424768|NCT00545948|P3|Participant Flow|Screen Failures|"Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.
Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures."
424769|NCT00545948|P2|Participant Flow|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
424770|NCT00545948|P1|Participant Flow|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
424771|NCT00545948|O2|Outcome|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
424772|NCT00545948|O1|Outcome|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
424773|NCT00545948|O1|Outcome|All Registered Patients|All registered/enrolled patients are included in this outcome, which was measured at the time of consent.
424774|NCT00545948|O1|Outcome|Treatment|Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study.
424775|NCT00545948|O1|Outcome|All Registered Patients|All registered/enrolled patients are included in this outcome, which was measured at the time of consent.
424776|NCT00545948|O1|Outcome|Treatment|Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for primary outcome analysis.
424777|NCT00545948|E2|Reported Event|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
424778|NCT00545948|E1|Reported Event|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
424779|NCT00545974|B3|Baseline|Total|Total of all reporting groups
424780|NCT00545974|B2|Baseline|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
424781|NCT00545974|B1|Baseline|Memantine|Memantine 10mg administered orally twice daily
424782|NCT00545974|P2|Participant Flow|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
424783|NCT00545974|P1|Participant Flow|Memantine|Memantine 10mg administered orally twice daily
424784|NCT00545974|O2|Outcome|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
424785|NCT00545974|O1|Outcome|Memantine|Memantine 10mg administered orally twice daily
424786|NCT00545974|O2|Outcome|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
424787|NCT00545974|O1|Outcome|Memantine|Memantine 10mg administered orally twice daily
424788|NCT00545974|E2|Reported Event|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
424789|NCT00545974|E1|Reported Event|Memantine|Memantine 10mg administered orally twice daily
424790|NCT00546000|B1|Baseline|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications"
424791|NCT00546000|P1|Participant Flow|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications"
424792|NCT00546000|O1|Outcome|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications"
424793|NCT00546000|O1|Outcome|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications"
424882|NCT00546273|B3|Baseline|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
424796|NCT00546078|B2|Baseline|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424797|NCT00546078|B1|Baseline|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424798|NCT00546078|P2|Participant Flow|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424799|NCT00546078|P1|Participant Flow|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424800|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424801|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424802|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424803|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424804|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424805|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424806|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424807|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424808|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424809|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424810|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424811|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424812|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424813|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424814|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424815|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424816|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424817|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424818|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424819|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424820|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424821|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424822|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424823|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424824|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424825|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424826|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424827|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424828|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424829|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424830|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424831|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424832|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424833|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424834|NCT00546078|E2|Reported Event|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
424835|NCT00546078|E1|Reported Event|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
424836|NCT00546104|B1|Baseline|Dasatinib|50-100mg by mouth twice a day
424837|NCT00546104|P1|Participant Flow|Dasatinib|50-100 mg PO BID
424838|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
424839|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
424840|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
424841|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
424842|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
424843|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
424844|NCT00546104|E1|Reported Event|Dasatinib|50-100mg po bid
424845|NCT00546117|B3|Baseline|Total|Total of all reporting groups
424846|NCT00546117|B2|Baseline|Placebo|Placebo SoluTab once daily for 2 months
424847|NCT00546117|B1|Baseline|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
424848|NCT00546117|P2|Participant Flow|Placebo|Placebo SoluTab once daily for 2 months
424849|NCT00546117|P1|Participant Flow|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
424850|NCT00546117|O2|Outcome|Placebo|Placebo SoluTab once daily for 2 months
424851|NCT00546117|O1|Outcome|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
424852|NCT00546117|O2|Outcome|Placebo|Placebo SoluTab once daily for 2 months
424853|NCT00546117|O1|Outcome|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
424854|NCT00546117|E2|Reported Event|Placebo|Placebo SoluTab once daily for 2 months
424855|NCT00546117|E1|Reported Event|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
424856|NCT00546156|B3|Baseline|Total|Total of all reporting groups
424857|NCT00546156|B2|Baseline|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
424858|NCT00546156|B1|Baseline|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
424859|NCT00546156|P2|Participant Flow|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
424860|NCT00546156|P1|Participant Flow|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
424861|NCT00546156|O2|Outcome|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
424862|NCT00546156|O1|Outcome|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
424863|NCT00546156|O2|Outcome|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
424864|NCT00546156|O1|Outcome|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
424865|NCT00546156|E1|Reported Event|All Study Participants|Patients with HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
424866|NCT00546260|B3|Baseline|Total|Total of all reporting groups
424867|NCT00546260|B2|Baseline|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
424868|NCT00546260|B1|Baseline|Placebo|Placebo Comparator
424869|NCT00546260|P2|Participant Flow|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
424870|NCT00546260|P1|Participant Flow|Placebo|Placebo Comparator
424871|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
424872|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
424873|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
424874|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
424875|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
424876|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
424877|NCT00546260|E2|Reported Event|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
424878|NCT00546260|E1|Reported Event|Placebo|Placebo Comparator
424879|NCT00546273|B6|Baseline|Total|Total of all reporting groups
425022|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
424883|NCT00546273|B2|Baseline|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
424884|NCT00546273|B1|Baseline|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
424885|NCT00546273|P5|Participant Flow|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
424886|NCT00546273|P4|Participant Flow|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
424887|NCT00546273|P3|Participant Flow|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
424888|NCT00546273|P2|Participant Flow|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
424889|NCT00546273|P1|Participant Flow|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
424890|NCT00546273|O5|Outcome|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
424891|NCT00546273|O4|Outcome|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
424892|NCT00546273|O3|Outcome|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
424893|NCT00546273|O2|Outcome|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
424894|NCT00546273|O1|Outcome|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
424895|NCT00546351|B1|Baseline|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424896|NCT00546351|P1|Participant Flow|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424897|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424898|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424899|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424900|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424901|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424902|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424903|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424904|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424905|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424906|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424907|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424908|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424909|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424910|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424911|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424912|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424913|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424914|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424915|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424916|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424917|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424918|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424919|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424920|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424921|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424922|NCT00546351|E1|Reported Event|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
424923|NCT00546364|B4|Baseline|Total|Total of all reporting groups
424924|NCT00546364|B3|Baseline|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424925|NCT00546364|B2|Baseline|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424926|NCT00546364|B1|Baseline|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424927|NCT00546364|P3|Participant Flow|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424928|NCT00546364|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424929|NCT00546364|P1|Participant Flow|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424930|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424931|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424932|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424933|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424934|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424935|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424936|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424937|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424938|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424939|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424940|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424941|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424942|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424943|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424944|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424945|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424946|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424947|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424948|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424949|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424950|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424951|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424952|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424953|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424954|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424955|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424956|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424957|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424958|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424959|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
424960|NCT00546364|E3|Reported Event|Ixabepilone 40|
424961|NCT00546364|E2|Reported Event|Ixabepilone 32|
424962|NCT00546364|E1|Reported Event|Docetaxel|
424963|NCT00546377|B1|Baseline|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
424964|NCT00546377|P1|Participant Flow|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
424965|NCT00546377|O1|Outcome|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
424966|NCT00546377|O1|Outcome|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
424967|NCT00546377|E1|Reported Event|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
424968|NCT00546429|B1|Baseline|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
424969|NCT00546429|P1|Participant Flow|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
424970|NCT00546429|O1|Outcome|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
424971|NCT00546429|E1|Reported Event|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
424972|NCT00546481|B3|Baseline|Total|Total of all reporting groups
424973|NCT00546481|B2|Baseline|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
424974|NCT00546481|B1|Baseline|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
424975|NCT00546481|P3|Participant Flow|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
424976|NCT00546481|P2|Participant Flow|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
424977|NCT00546481|P1|Participant Flow|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
424978|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
424979|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
424980|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
424981|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
424982|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
424983|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
424984|NCT00546481|O3|Outcome|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
424985|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
424986|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
424987|NCT00546481|O3|Outcome|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
424988|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
424989|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
424990|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
424991|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
424992|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
424993|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
424994|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
424995|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
424996|NCT00546481|E3|Reported Event|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined protocol) IV once every 4 weeks for the subsequent 24 weeks.
424997|NCT00546481|E2|Reported Event|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
424998|NCT00546481|E1|Reported Event|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
424999|NCT00546572|B3|Baseline|Total|Total of all reporting groups
425000|NCT00546572|B2|Baseline|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
425001|NCT00546572|B1|Baseline|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
425002|NCT00546572|P2|Participant Flow|23vPS / 13vPnC|23-valent pneumococcal polysaccharide conjugate vaccine (23vPS) 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
425003|NCT00546572|P1|Participant Flow|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliters (mL) dose intramuscularly (IM) at Year 0 (vaccination 1 [Vax 1]) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
425004|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425005|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
425006|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax )
425007|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425008|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425009|NCT00546572|O1|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
425010|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425011|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
425012|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
425013|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
425014|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425015|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
425016|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425017|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425018|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425019|NCT00546572|O1|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
425020|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425021|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
425023|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
425024|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
425025|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425026|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
425027|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425028|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
425029|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
425030|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
425031|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
425032|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
425033|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
425034|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
425035|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
425036|NCT00546572|E8|Reported Event|23vPS / 13vPnC 6-M FU (Vax 2 / Year 1)|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose at Year 1 (Vax 2); events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
425037|NCT00546572|E7|Reported Event|13vPnC / 13vPnC 6-M FU (Vax 2 / Year 1)|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2) ; events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
425038|NCT00546572|E6|Reported Event|23vPS / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination|"23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=62; systematic (solicited) Local Reactions N=189; systematic (solicited) Systemic Events N=174."
425039|NCT00546572|E5|Reported Event|13vPnC / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination|"13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=191; systematic (solicited) Systemic Events N=161."
425040|NCT00546572|E4|Reported Event|23vPS 6-M FU (Vax 1 / Year 0)|23vPS 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-M FU (Vax 1 / Year 0) telephone visit to report new events.
425041|NCT00546572|E3|Reported Event|13vPnC 6-M FU (Vax 1 / Year 0)|13vPnC 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-Month Follow-up visit (6-M FU) (Vax 1 / Year 0) telephone visit to report new events.
425042|NCT00546572|E2|Reported Event|23vPS (Vax 1 / Year 0) 1 Month After Vaccination|"23vPS 0.5 mL dose IM at Year 0 (Vax 1)
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=83; systematic (solicited) Local Reactions N=248; systematic (solicited) Systemic Events N=275."
425043|NCT00546572|E1|Reported Event|13vPnC (Vax 1 / Year 0) 1 Month After Vaccination|"13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=66; systematic (solicited) Local Reactions N=209; systematic (solicited) Systemic Events N=234."
425044|NCT00546637|B3|Baseline|Total|Total of all reporting groups
425045|NCT00546637|B2|Baseline|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425046|NCT00546637|B1|Baseline|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425047|NCT00546637|P2|Participant Flow|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425048|NCT00546637|P1|Participant Flow|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425049|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425050|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425051|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425052|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425053|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425054|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425055|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425056|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425057|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425058|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425059|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425060|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425061|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425062|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425063|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425064|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425065|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425066|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425067|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425068|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425069|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425070|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425071|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425072|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425073|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425074|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425075|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425076|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425077|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425078|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425079|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425080|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425130|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425131|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425081|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425082|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425083|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425084|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425085|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425086|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425087|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425088|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425089|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425090|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425091|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425092|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425093|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425094|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425132|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425133|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425095|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425096|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425097|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425098|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425099|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425100|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425101|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425102|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425103|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425104|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425105|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425106|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425107|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425108|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425134|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425135|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425109|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425110|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425111|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425112|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425113|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425114|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425115|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425116|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425117|NCT00546637|E2|Reported Event|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
425118|NCT00546637|E1|Reported Event|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
425119|NCT00546715|B5|Baseline|Total|Total of all reporting groups
425120|NCT00546715|B4|Baseline|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425121|NCT00546715|B3|Baseline|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425122|NCT00546715|B2|Baseline|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425123|NCT00546715|B1|Baseline|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425124|NCT00546715|P4|Participant Flow|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425125|NCT00546715|P3|Participant Flow|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425126|NCT00546715|P2|Participant Flow|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425127|NCT00546715|P1|Participant Flow|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425128|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425129|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425555|NCT00547911|B1|Baseline|Healthy Volunteer|Subjects in good general health
425136|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425137|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425138|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425139|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425140|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425141|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425142|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425143|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425144|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425145|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425146|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425147|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425148|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425149|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425150|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425151|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425152|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425153|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425154|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425155|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425156|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425157|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425158|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425159|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425160|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425161|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425162|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425163|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425164|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425165|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425166|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425167|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425852|NCT00542386|P6|Participant Flow|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
425168|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425169|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425170|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425171|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425172|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425173|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425174|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425175|NCT00546715|E4|Reported Event|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425176|NCT00546715|E3|Reported Event|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425177|NCT00546715|E2|Reported Event|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425178|NCT00546715|E1|Reported Event|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
425179|NCT00546728|B3|Baseline|Total|Total of all reporting groups
425180|NCT00546728|B2|Baseline|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
425181|NCT00546728|B1|Baseline|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
425182|NCT00546728|P2|Participant Flow|Metformin|Three months of Metformin. Metformin was initiated at a dose of 500 mg, twice a day for one month and up titrated to 1000 mg, twice a day for the remaining two months.
425183|NCT00546728|P1|Participant Flow|Exenatide|Three months of Exenatide. Exenatide was initiated at a dose of 5 mcg, twice a day for one month and up titrated to 10 mcg, twice a day for the remaining two months.
425184|NCT00546728|O2|Outcome|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
425185|NCT00546728|O1|Outcome|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
425186|NCT00546728|E2|Reported Event|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
425187|NCT00546728|E1|Reported Event|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
425188|NCT00546754|B3|Baseline|Total|Total of all reporting groups
425189|NCT00546754|B2|Baseline|Valsartan 80 mg/HCTZ 12.5 mg|"Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])"
425190|NCT00546754|B1|Baseline|Losartan 50 mg/HCTZ 12.5 mg|"Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
416 number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])"
425191|NCT00546754|P2|Participant Flow|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425192|NCT00546754|P1|Participant Flow|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425193|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425194|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425195|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425196|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425197|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425198|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425199|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425200|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425201|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425202|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425203|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425204|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425205|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425206|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425207|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425208|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425209|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425210|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425211|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425212|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425213|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425214|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425215|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425216|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425217|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425218|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425219|NCT00546754|E2|Reported Event|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425220|NCT00546754|E1|Reported Event|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
425221|NCT00546819|B3|Baseline|Total|Total of all reporting groups
425222|NCT00546819|B2|Baseline|Placebo|Participants administered Placebo on Day 1.
425223|NCT00546819|B1|Baseline|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
425224|NCT00546819|P2|Participant Flow|Placebo|Participants administered Placebo on Day 1.
425225|NCT00546819|P1|Participant Flow|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
425226|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
425227|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
425228|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
425229|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
425230|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
425231|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
425232|NCT00546819|E2|Reported Event|Placebo|Participants administered Placebo on Day 1.
425233|NCT00546819|E1|Reported Event|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
425234|NCT00546871|B1|Baseline|Treated Participants|
425235|NCT00546871|P2|Participant Flow|12 Years and Older|"Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined Adjusted Dose in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted
Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows:
If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a
If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension"
425297|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
425298|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
425299|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
425300|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
425236|NCT00546871|P1|Participant Flow|2 to <12 Years|"Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined Adjusted Dose in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted
Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows:
If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a
If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension"
425237|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
425238|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
425239|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
425240|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
425241|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
425242|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
425243|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
425244|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
425245|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
425246|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
425247|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
425248|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
425249|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
425250|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
425251|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
425252|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
425253|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
425254|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
425255|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
425256|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
425257|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
425258|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
425259|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
425260|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
425261|NCT00546871|O5|Outcome|Study Extension, SC Administration|
425262|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
425263|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
425264|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
425265|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
425266|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
425267|NCT00546871|O5|Outcome|Study Extension, SC Administration|
425268|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
425269|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
425270|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
425271|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
425272|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
425273|NCT00546871|O5|Outcome|Study Extension, SC Administration|
425274|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
425275|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
425276|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
425277|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
425278|NCT00546871|O6|Outcome|Total SC (Study Parts 2, 3a, 3b, Extension)|
425279|NCT00546871|O5|Outcome|Study Extension, SC Administration|
425280|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
425281|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
425282|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
425283|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
425284|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
425285|NCT00546871|O5|Outcome|Study Extension, SC Administration|
425286|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
425287|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
425288|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
425289|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
425290|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
425291|NCT00546871|O5|Outcome|Study Extension, SC Administration|
425292|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
425293|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
425294|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
425295|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
425296|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
425301|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
425302|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
425303|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
425304|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
425305|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
425306|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
425307|NCT00546871|O3|Outcome|SESC|Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins
425308|NCT00546871|O2|Outcome|SNSC|Dataset of subjects naïve to SC administration of immunoglobulins
425309|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
425310|NCT00546871|O2|Outcome|All SC Treatment Periods|Study Parts 2, 3a, 3b, extension
425311|NCT00546871|O1|Outcome|IV Treatment|Study Part 1
425312|NCT00546871|O2|Outcome|12 Years and Older|
425313|NCT00546871|O1|Outcome|2 to <12 Years|
425314|NCT00546871|O1|Outcome|Full Safety Data Set|
425315|NCT00546871|O1|Outcome|All Participants|
425316|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
425317|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
425318|NCT00546871|O1|Outcome|All Participants|
425319|NCT00546871|O1|Outcome|All Participants|
425320|NCT00546871|O1|Outcome|12 Years and Older|
425321|NCT00546871|O1|Outcome|12 Years and Older|
425322|NCT00546871|O1|Outcome|12 Years and Older|
425323|NCT00546871|O1|Outcome|12 Years and Older|
425324|NCT00546871|O1|Outcome|12 Years and Older|
425325|NCT00546871|O1|Outcome|12 Years and Older|
425326|NCT00546871|O1|Outcome|12 Years and Older|
425327|NCT00546871|O1|Outcome|12 Years and Older|
425328|NCT00546871|O1|Outcome|12 Years and Older|
425329|NCT00546871|O1|Outcome|12 Years and Older|
425330|NCT00546871|O1|Outcome|12 Years and Older|
425331|NCT00546871|O1|Outcome|12 Years and Older|
425332|NCT00546871|O1|Outcome|12 Years and Older|
425333|NCT00546871|O1|Outcome|12 Years and Older|
425334|NCT00546871|O1|Outcome|Participants Aged 2 to <12 Years|
425335|NCT00546871|O1|Outcome|Participants ≥12 Years Old With PK Data Part 1 and Part 3b|"IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks).
SC dosing for Study Part 3b was determined by:
From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the Adjusted Dose.
Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an Individually Adapted Dose to ensure sufficient trough levels.
Study Part 3b:
Participants received weekly SC infusions for 12 weeks. Dose administered was either:
The Adjusted Dose
Individually Adapted Dose"
425336|NCT00546871|E2|Reported Event|SC Treatment Period|Study Parts 2, 3a, 3b, and Extension
425337|NCT00546871|E1|Reported Event|IV Treatment Period|Study Part 1
425338|NCT00546884|B3|Baseline|Total|Total of all reporting groups
425339|NCT00546884|B2|Baseline|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care
GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
425340|NCT00546884|B1|Baseline|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.
MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
425341|NCT00546884|P2|Participant Flow|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care
GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
425342|NCT00546884|P1|Participant Flow|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.
MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
425343|NCT00546884|O2|Outcome|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care
GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
425344|NCT00546884|O1|Outcome|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.
MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
425345|NCT00546884|E2|Reported Event|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care
GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
425346|NCT00546884|E1|Reported Event|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.
MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
425347|NCT00546897|B3|Baseline|Total|Total of all reporting groups
425429|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
425348|NCT00546897|B2|Baseline|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425349|NCT00546897|B1|Baseline|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425350|NCT00546897|P2|Participant Flow|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425351|NCT00546897|P1|Participant Flow|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425352|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425353|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425354|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425355|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425356|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425357|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425358|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425359|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425360|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425361|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425362|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425363|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425364|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425365|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425366|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425367|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425368|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425369|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425370|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425371|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425372|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425373|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425374|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425375|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425376|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425377|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425378|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425379|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425380|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425381|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425382|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425383|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425384|NCT00546897|E2|Reported Event|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.
Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
425385|NCT00546897|E1|Reported Event|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).
If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
425386|NCT00546910|B3|Baseline|Total|Total of all reporting groups
425387|NCT00546910|B2|Baseline|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
425388|NCT00546910|B1|Baseline|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
425389|NCT00546910|P2|Participant Flow|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
425390|NCT00546910|P1|Participant Flow|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
425391|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
425392|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
425393|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
425394|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
425395|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
425396|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
425397|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
425398|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
425399|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
425400|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
425401|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
425402|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
425403|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
425404|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
425405|NCT00546910|E2|Reported Event|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
425406|NCT00546910|E1|Reported Event|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
425407|NCT00547118|B3|Baseline|Total|Total of all reporting groups
425408|NCT00547118|B2|Baseline|Placebo|"Placebo
Placebo: Placebo"
425409|NCT00547118|B1|Baseline|Rimonabant|"Rimonabant
Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days."
425410|NCT00547118|P2|Participant Flow|Placebo|"Placebo
Placebo: Placebo"
425411|NCT00547118|P1|Participant Flow|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
425412|NCT00547118|O2|Outcome|Placebo|"Placebo
Placebo: Placebo"
425413|NCT00547118|O1|Outcome|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
425414|NCT00547118|E2|Reported Event|Placebo|"Placebo
Placebo: Placebo"
425415|NCT00547118|E1|Reported Event|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
425416|NCT00547157|B3|Baseline|Total|Total of all reporting groups
425417|NCT00547157|B2|Baseline|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
425418|NCT00547157|B1|Baseline|Panitumumab Plus Radiotherpy|Consists of Panitumumab and Radiotherpy
425419|NCT00547157|P2|Participant Flow|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
425420|NCT00547157|P1|Participant Flow|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
425421|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
425422|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
425423|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
425424|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
425425|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
425426|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
425427|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
425428|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
425853|NCT00542386|P5|Participant Flow|MCI-196: 15 g|MCI-196: 15 g/ day
425430|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
425431|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
425432|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
425433|NCT00547157|E2|Reported Event|Chemotherapy Plus Radiotherapy|
425434|NCT00547157|E1|Reported Event|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
425435|NCT00547365|B1|Baseline|Human Immune Globulin Intravenous (IGIV)|
425436|NCT00547365|P1|Participant Flow|Human Immune Globulin Intravenous (IGIV)|The therapeutic potential of human immune globulin intravenous (IGIV)was evaluated in patients with cardiac-associated AL amyloidosis. Patients received, via intravenous infusion, 30-40 gm of IGIV (depending on body weight) weekly for 3 months and then every other week for the next 9 months.The total time to complete the study was ~1 yr.
425437|NCT00547365|O1|Outcome|Human Immune Globulin Intravenous (IGIV)|Human immune globulin intravenous (IGIV) was infused into 10 patients with cardiac-associated AL amyloidosis and its therapeutic potential evaluated through measurement of serum anti-fibril IgG antibody levels, as well as amyloid burden, pre- and post-administration.
425438|NCT00547365|O1|Outcome|Human Immune Globulin Intravenous (IGIV)|Immune globulin intravenous (IGIV) was administered to patients with cardiac-dominant AL amyloidosis in order to determine its therapeutic potential or possible toxicity when given to subjects weekly for 3 months and then every other week for the next 9 months. Response was evaluated by changes in serum anti-fibril antibody levels, changes in BNP (B-type natriuretic peptide) levels and IVS (interventricular septum) thickness.
425439|NCT00547365|E1|Reported Event|Human Immune Globulin Intravenous (IGIV)|Therapeutic potential of human immune globulin intravenous (IGIV)in patients with cardiac-associated AL amyloidosis
425440|NCT00547456|B1|Baseline|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
Oxygen: Oxygen 2-3L Nasal cannula"
425441|NCT00547456|P1|Participant Flow|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
Oxygen: Oxygen 2-3L Nasal cannula"
425442|NCT00547456|O1|Outcome|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
Oxygen: Oxygen 2-3L Nasal cannula"
425443|NCT00547456|E1|Reported Event|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
Oxygen: Oxygen 2-3L Nasal cannula"
425444|NCT00547521|B3|Baseline|Total|Total of all reporting groups
425445|NCT00547521|B2|Baseline|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425446|NCT00547521|B1|Baseline|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425447|NCT00547521|P2|Participant Flow|SC Abatacept Cohort|In the ST period, participants in this cohort were administered monotherapy, a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During the LTE, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE period, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition. LTE period pooled all participants into 1 arm. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
425448|NCT00547521|P1|Participant Flow|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425449|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425450|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425451|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425452|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425453|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425454|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425455|NCT00547521|O1|Outcome|Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
425456|NCT00547521|O1|Outcome|Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
425457|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425458|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425459|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425460|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425461|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425462|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
425463|NCT00547521|O1|Outcome|Abatacept Long Term Extension (LTE) Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
425464|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425465|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425466|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425467|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425468|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During LTE period, all eligible participants continued to self administer abatacept (125 mg SC) on a weekly basis.
425552|NCT00547911|B4|Baseline|Parkinson's Disease|Subjects with autonomic failure and a history of Parkinson's Disease
425854|NCT00542386|P4|Participant Flow|MCI-196: 12 g|MCI-196: 12 g/ day
425469|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. During LTE period, adjustments to MTX were permitted at the investigator’s discretion based upon the participant’s clinical status.
425470|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425471|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425472|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425473|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425474|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425475|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425476|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425477|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425478|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During LTE period, all eligible participants continued to self administer abatacept (125 mg SC) on a weekly basis.
425479|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. During LTE period, adjustments to MTX were permitted at the investigator’s discretion based upon the participant’s clinical status.
425480|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425481|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425482|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425483|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425484|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425485|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425486|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425487|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425488|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425553|NCT00547911|B3|Baseline|Multiple System Atrophy|Subjects with autonomic failure and a history of Multiple System Atrophy
425554|NCT00547911|B2|Baseline|Pure Autonomic Failure|Subjects with Pure Autonomic Failure
425489|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425490|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425491|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425492|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425493|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425494|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425495|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425496|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425497|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425498|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425499|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425500|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425501|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425502|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425503|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425504|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425505|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425506|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425507|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425508|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425509|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425855|NCT00542386|P3|Participant Flow|MCI-196: 9 g|MCI-196: 9 g/ day
425510|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425511|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425512|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425513|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425514|NCT00547521|E3|Reported Event|Long Term Extension (LTE):125 mg SC Abatacept|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition.
425515|NCT00547521|E2|Reported Event|Short Term Study: SC Abatacept Monotherapy|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
425516|NCT00547521|E1|Reported Event|Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
425517|NCT00547534|B1|Baseline|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
425518|NCT00547534|P1|Participant Flow|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
425519|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated.
425520|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated
425521|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated.
425522|NCT00547534|E1|Reported Event|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
425523|NCT00547638|B3|Baseline|Total|Total of all reporting groups
425524|NCT00547638|B2|Baseline|Dermabond HVD|DERMABOND HVD: Comparator Tissue Adhesive for Topical Application
425525|NCT00547638|B1|Baseline|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo) Tissue adhesive for Topical Application
425526|NCT00547638|P2|Participant Flow|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
425527|NCT00547638|P1|Participant Flow|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
425528|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
425529|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
425530|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
425531|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
425532|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
425533|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
425534|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
425535|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
425536|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
425537|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
425538|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
425539|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
425540|NCT00547638|E2|Reported Event|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
425541|NCT00547638|E1|Reported Event|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
425542|NCT00547703|B3|Baseline|Total|Total of all reporting groups
425543|NCT00547703|B2|Baseline|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
425544|NCT00547703|B1|Baseline|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
425545|NCT00547703|P2|Participant Flow|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
425546|NCT00547703|P1|Participant Flow|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
425547|NCT00547703|O2|Outcome|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
425548|NCT00547703|O1|Outcome|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
425549|NCT00547703|E2|Reported Event|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
425550|NCT00547703|E1|Reported Event|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
425551|NCT00547911|B5|Baseline|Total|Total of all reporting groups
425856|NCT00542386|P2|Participant Flow|MCI-196: 6 g|MCI-196: 6 g/ day
425556|NCT00547911|P6|Participant Flow|LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
425557|NCT00547911|P5|Participant Flow|LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
425558|NCT00547911|P4|Participant Flow|LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
425559|NCT00547911|P3|Participant Flow|LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
425560|NCT00547911|P2|Participant Flow|LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
425561|NCT00547911|P1|Participant Flow|LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
425562|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
425563|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
425564|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
425565|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
425566|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
425567|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
425568|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
425569|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
425570|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
425571|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
425572|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of placebo
425573|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
425574|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
425575|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
425576|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
425577|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of carbidopa
425578|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
425579|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
425580|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
425581|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
425582|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
425583|NCT00547911|E6|Reported Event|LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
425614|NCT00548184|P1|Participant Flow|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and Trastuzumab 4mg/kg loading dose and then 2mg/kg every week
425696|NCT00548327|O1|Outcome|Healthy Participants|Atomoxetine 40 mg twice daily (bid), placebo, Val/Val, Val/Met, Met/Met.
425584|NCT00547911|E5|Reported Event|LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
425585|NCT00547911|E4|Reported Event|LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
425586|NCT00547911|E3|Reported Event|LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
425587|NCT00547911|E2|Reported Event|LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
425588|NCT00547911|E1|Reported Event|LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
425589|NCT00548041|B1|Baseline|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
425590|NCT00548041|P1|Participant Flow|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
425591|NCT00548041|O1|Outcome|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
425592|NCT00548041|E1|Reported Event|Subjects Undergoing HIV Testing in the ED|
425593|NCT00548132|B3|Baseline|Total|Total of all reporting groups
425594|NCT00548132|B2|Baseline|Chlorhexidine-impregnated Foam Dressing|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
425595|NCT00548132|B1|Baseline|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
425596|NCT00548132|P2|Participant Flow|Chlorhexidine-impregnated Foam Dressing|
425597|NCT00548132|P1|Participant Flow|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
425598|NCT00548132|O2|Outcome|Intervention Group|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
425599|NCT00548132|O1|Outcome|Standard of Care|Standard catheter care-use of chlorhexidine-alcohol solution to prep the catheter site and then a bioocclusive dressing is applied
425600|NCT00548132|O2|Outcome|Chlorhexidine Impregnated Sponge|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
425601|NCT00548132|O1|Outcome|Standard of Care|Standard of care
425602|NCT00548132|E2|Reported Event|Chlorhexidine-impregnated Foam Dressing|
425603|NCT00548132|E1|Reported Event|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
425604|NCT00548145|B3|Baseline|Total|Total of all reporting groups
425605|NCT00548145|B2|Baseline|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
425606|NCT00548145|B1|Baseline|Pitavastatin|2 mg by orally/day Duration: 12 months
425607|NCT00548145|P2|Participant Flow|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
425608|NCT00548145|P1|Participant Flow|Pitavastatin|2 mg by orally/day Duration: 12 months
425609|NCT00548145|O2|Outcome|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
425610|NCT00548145|O1|Outcome|Pitavastatin|2 mg by orally/day Duration: 12 months
425611|NCT00548145|E2|Reported Event|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
425612|NCT00548145|E1|Reported Event|Pitavastatin|2 mg by orally/day Duration: 12 months
425613|NCT00548184|B1|Baseline|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
425615|NCT00548184|O1|Outcome|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week
425616|NCT00548184|E1|Reported Event|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
425617|NCT00548249|B6|Baseline|Total|Total of all reporting groups
425618|NCT00548249|B5|Baseline|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425619|NCT00548249|B4|Baseline|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425620|NCT00548249|B3|Baseline|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425621|NCT00548249|B2|Baseline|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425622|NCT00548249|B1|Baseline|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425623|NCT00548249|P5|Participant Flow|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425624|NCT00548249|P4|Participant Flow|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425625|NCT00548249|P3|Participant Flow|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425626|NCT00548249|P2|Participant Flow|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425627|NCT00548249|P1|Participant Flow|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425628|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425629|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425630|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425631|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425632|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425633|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425634|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425635|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425636|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425637|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425638|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425639|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425640|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425641|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425642|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425643|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425644|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425645|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425646|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425647|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425648|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425649|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425650|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425651|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425652|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425653|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425654|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425655|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425656|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425657|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425658|NCT00548249|E5|Reported Event|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425659|NCT00548249|E4|Reported Event|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425660|NCT00548249|E3|Reported Event|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425661|NCT00548249|E2|Reported Event|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425662|NCT00548249|E1|Reported Event|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
425663|NCT00548262|B1|Baseline|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425664|NCT00548262|P1|Participant Flow|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425665|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425666|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425667|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425668|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425669|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425670|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425671|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425672|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425673|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425674|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425675|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425676|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425677|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425678|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425679|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425680|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425681|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425682|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425683|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425684|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425685|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425686|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425687|NCT00548262|E1|Reported Event|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
425688|NCT00548327|B3|Baseline|Total|Total of all reporting groups
425689|NCT00548327|B2|Baseline|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.
Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).
Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
425690|NCT00548327|B1|Baseline|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.
Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).
Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
425691|NCT00548327|P2|Participant Flow|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.
Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).
Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
425692|NCT00548327|P1|Participant Flow|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.
Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).
Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
425693|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.
Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).
Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
425694|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.
Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).
Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
425698|NCT00548327|O1|Outcome|Healthy Participants|Atomoxetine 40 mg twice daily (bid), placebo, Val/Val, Val/Met, Met/Met.
425699|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.
Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).
Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
425700|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.
Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).
Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
425701|NCT00548327|O2|Outcome|Patients With Schizophrenia|
425702|NCT00548327|O1|Outcome|Healthy Participants|
425703|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.
Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).
Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
425704|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.
Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).
Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
425705|NCT00548327|E4|Reported Event|Placebo-Healthy Volunteer|
425706|NCT00548327|E3|Reported Event|Atomoxetine-Healthy Volunteer|
425707|NCT00548327|E2|Reported Event|Placebo-Patient|
425708|NCT00548327|E1|Reported Event|Atomoxetine-Patient|
425709|NCT00548340|B4|Baseline|Total|Total of all reporting groups
425710|NCT00548340|B3|Baseline|Placebo|Placebo: Placebo capsules, PO daily for five weeks
425711|NCT00548340|B2|Baseline|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
425712|NCT00548340|B1|Baseline|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
425713|NCT00548340|P3|Participant Flow|Placebo|Placebo: Placebo capsules, PO daily for five weeks
425714|NCT00548340|P2|Participant Flow|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
425715|NCT00548340|P1|Participant Flow|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
425716|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
425717|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
425718|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
425719|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
425720|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
425721|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
425722|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
425723|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
425724|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
425725|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
425726|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
425727|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
425728|NCT00548340|E3|Reported Event|Placebo|Placebo: Placebo capsules, PO daily for five weeks
425729|NCT00548340|E2|Reported Event|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
425730|NCT00548340|E1|Reported Event|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
425731|NCT00548405|B4|Baseline|Total|Total of all reporting groups
425732|NCT00548405|B3|Baseline|Alemtuzumab 24mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
425733|NCT00548405|B2|Baseline|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
425734|NCT00548405|B1|Baseline|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
425735|NCT00548405|P3|Participant Flow|Alemtuzumab 24mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
425736|NCT00548405|P2|Participant Flow|Alemtuzumab 12 mg|Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
425737|NCT00548405|P1|Participant Flow|Interferon Beta-1a|Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
425738|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
425739|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
425740|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
425741|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
425742|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
425743|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
425744|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
425745|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
425746|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
425747|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
425748|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
425749|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
425750|NCT00548405|E4|Reported Event|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg or 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg or 24 mg per day IV infusion on 3 consecutive days at Month 12.
425751|NCT00548405|E3|Reported Event|Alemtuzumab 24 mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
425752|NCT00548405|E2|Reported Event|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
425753|NCT00548405|E1|Reported Event|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
425754|NCT00548418|B1|Baseline|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
425755|NCT00548418|P1|Participant Flow|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
425756|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
425757|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
425758|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
425759|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
425760|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
425761|NCT00548418|E1|Reported Event|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
425762|NCT00548431|B1|Baseline|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
425763|NCT00548431|P1|Participant Flow|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
425764|NCT00548431|O1|Outcome|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
425765|NCT00548431|E1|Reported Event|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
425766|NCT00548548|B3|Baseline|Total|Total of all reporting groups
425767|NCT00548548|B2|Baseline|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425857|NCT00542386|P1|Participant Flow|MCI-196: 3 g|MCI-196: 3 g/ day
425858|NCT00542386|O6|Outcome|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
425859|NCT00542386|O5|Outcome|MCI-196: 15 g|MCI-196: 15 g/ day
425768|NCT00548548|B1|Baseline|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425769|NCT00548548|P2|Participant Flow|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425770|NCT00548548|P1|Participant Flow|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425771|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425772|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425773|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425774|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425775|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425776|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425777|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425778|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425779|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425780|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425781|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425782|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425860|NCT00542386|O4|Outcome|MCI-196: 12 g|MCI-196: 12 g/ day
425783|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425784|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425785|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425786|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425787|NCT00548548|E2|Reported Event|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425788|NCT00548548|E1|Reported Event|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
425789|NCT00542269|B4|Baseline|Total|Total of all reporting groups
425790|NCT00542269|B3|Baseline|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425791|NCT00542269|B2|Baseline|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425792|NCT00542269|B1|Baseline|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425793|NCT00542269|P3|Participant Flow|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425794|NCT00542269|P2|Participant Flow|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425795|NCT00542269|P1|Participant Flow|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425796|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425797|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425798|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425799|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425800|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425801|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425802|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425803|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425804|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425805|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425806|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425807|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425861|NCT00542386|O3|Outcome|MCI-196: 9 g|MCI-196: 9 g/ day
425862|NCT00542386|O2|Outcome|MCI-196: 6 g|MCI-196: 6 g/ day
425863|NCT00542386|O1|Outcome|MCI-196: 3 g|MCI-196: 3 g/ day
425864|NCT00542386|O6|Outcome|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
425865|NCT00542386|O5|Outcome|MCI-196: 15 g|MCI-196: 15 g/ day
425866|NCT00542386|O4|Outcome|MCI-196: 12 g|MCI-196: 12 g/ day
425808|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425809|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425810|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425811|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425812|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425813|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425814|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425815|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425816|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425817|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425818|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425867|NCT00542386|O3|Outcome|MCI-196: 9 g|MCI-196: 9 g/ day
425868|NCT00542386|O2|Outcome|MCI-196: 6 g|MCI-196: 6 g/ day
425869|NCT00542386|O1|Outcome|MCI-196: 3 g|MCI-196: 3 g/ day
425870|NCT00542386|E6|Reported Event|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
425871|NCT00542386|E5|Reported Event|MCI-196: 15 g|MCI-196: 15 g/ day
425872|NCT00542386|E4|Reported Event|MCI-196: 12 g|MCI-196: 12 g/ day
425819|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425820|NCT00542269|E3|Reported Event|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425821|NCT00542269|E2|Reported Event|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425822|NCT00542269|E1|Reported Event|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
425823|NCT00542308|B1|Baseline|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
425824|NCT00542308|P1|Participant Flow|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
425825|NCT00542308|O1|Outcome|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
425826|NCT00542308|O1|Outcome|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
425827|NCT00542308|E1|Reported Event|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
425828|NCT00542321|B3|Baseline|Total|Total of all reporting groups
425829|NCT00542321|B2|Baseline|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
425830|NCT00542321|B1|Baseline|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
425831|NCT00542321|P2|Participant Flow|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
425832|NCT00542321|P1|Participant Flow|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
425833|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
425834|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
425835|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
425836|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
425837|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
425838|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
425839|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
425840|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
425841|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
425842|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
425843|NCT00542321|E2|Reported Event|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
425844|NCT00542321|E1|Reported Event|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
425845|NCT00542386|B7|Baseline|Total|Total of all reporting groups
425846|NCT00542386|B6|Baseline|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
425847|NCT00542386|B5|Baseline|MCI-196: 15 g|MCI-196: 15 g/ day
425848|NCT00542386|B4|Baseline|MCI-196: 12 g|MCI-196: 12 g/ day
425849|NCT00542386|B3|Baseline|MCI-196: 9 g|MCI-196: 9 g/ day
425918|NCT00542542|B2|Baseline|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.
Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.
Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
425919|NCT00542542|B1|Baseline|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)
Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.
Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
425920|NCT00542542|P2|Participant Flow|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.
Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.
Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
425921|NCT00542542|P1|Participant Flow|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)
Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.
Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
425922|NCT00542542|O2|Outcome|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.
Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.
Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
425923|NCT00542542|O1|Outcome|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)
Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.
Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
425924|NCT00542542|E2|Reported Event|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.
Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.
Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
425925|NCT00542542|E1|Reported Event|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)
Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.
Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
425926|NCT00542620|B3|Baseline|Total|Total of all reporting groups
425927|NCT00542620|B2|Baseline|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425928|NCT00542620|B1|Baseline|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425929|NCT00542620|P2|Participant Flow|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425930|NCT00542620|P1|Participant Flow|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425931|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425932|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425933|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425934|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425935|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425936|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425937|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425938|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425939|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425940|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425941|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425942|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425943|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425944|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425945|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425946|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425947|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425948|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425949|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425950|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425951|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425952|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425953|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425954|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425955|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425956|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425957|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425958|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425959|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425960|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425961|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425962|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425963|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425964|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425965|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425966|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425967|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425968|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425969|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425970|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425971|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
426010|NCT00542815|P3|Participant Flow|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
426011|NCT00542815|P2|Participant Flow|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
425972|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425973|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425974|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425975|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425976|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425977|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425978|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425979|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425980|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425981|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425982|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425983|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425984|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425985|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425986|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425987|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425988|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425989|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425990|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425991|NCT00542620|E2|Reported Event|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425992|NCT00542620|E1|Reported Event|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
425993|NCT00542789|B3|Baseline|Total|Total of all reporting groups
425994|NCT00542789|B2|Baseline|Comparater: Placebo|Placebo once daily oral
425995|NCT00542789|B1|Baseline|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
425996|NCT00542789|P2|Participant Flow|Comparater: Placebo|Placebo once daily oral
425997|NCT00542789|P1|Participant Flow|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
425998|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
425999|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
426000|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
426001|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
426002|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
426003|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
426004|NCT00542789|E2|Reported Event|Comparater: Placebo|Placebo once daily oral
426005|NCT00542789|E1|Reported Event|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
426006|NCT00542815|B4|Baseline|Total|Total of all reporting groups
426007|NCT00542815|B3|Baseline|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
426008|NCT00542815|B2|Baseline|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
426009|NCT00542815|B1|Baseline|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
426012|NCT00542815|P1|Participant Flow|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
426013|NCT00542815|O3|Outcome|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
426014|NCT00542815|O2|Outcome|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
426015|NCT00542815|O1|Outcome|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
426016|NCT00542815|O3|Outcome|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
426017|NCT00542815|O2|Outcome|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
426018|NCT00542815|O1|Outcome|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
426019|NCT00542815|E3|Reported Event|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
426020|NCT00542815|E2|Reported Event|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
426021|NCT00542815|E1|Reported Event|MCI-196 From E07/E08 Studies|3, 6, 9, 12, or 15g / day as titrated
426022|NCT00542828|B1|Baseline|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426023|NCT00542828|P1|Participant Flow|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426024|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426025|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426026|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426027|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426028|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426029|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426030|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426031|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426032|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426033|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426034|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426035|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426036|NCT00542828|E1|Reported Event|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
426037|NCT00542880|B3|Baseline|Total|Total of all reporting groups
426038|NCT00542880|B2|Baseline|Seretide Diskus First, Then Symbicort Turbuhaler|Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426039|NCT00542880|B1|Baseline|Symbicort Turbuhaler First, Then Seretide Diskus|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426040|NCT00542880|P2|Participant Flow|Seretide Diskus First, Then Symbicort Turbuhaler|Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426041|NCT00542880|P1|Participant Flow|Symbicort Turbuhaler First, Then Seretide Diskus|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426042|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426043|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426044|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426045|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426046|NCT00542880|O2|Outcome|Seretide Diskus First|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426047|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426048|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426049|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426050|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426051|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426052|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426053|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426054|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426055|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426056|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426057|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426058|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426059|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426060|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426061|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426062|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426063|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426064|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426065|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426066|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426067|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426068|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426069|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426070|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426071|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426072|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426073|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426074|NCT00542880|E2|Reported Event|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
426075|NCT00542880|E1|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
426076|NCT00542971|B1|Baseline|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
426077|NCT00542971|P1|Participant Flow|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
426078|NCT00542971|O1|Outcome|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
426079|NCT00542971|O1|Outcome|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
426080|NCT00542971|E1|Reported Event|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
426081|NCT00542997|B1|Baseline|IgPro20 (All Treated)|All subjects enrolled and treated with subcutaneous infusion of IgPro20
426082|NCT00542997|P1|Participant Flow|IgPro20 (All Treated)|All subjects receiving at least 1 infusion of IgPro20
426083|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
426084|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
426085|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
426086|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
426087|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
426088|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
426089|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
426090|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
426091|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
426092|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
426093|NCT00542997|O2|Outcome|Pre-study IgG Treatment|Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
426094|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
426095|NCT00542997|E1|Reported Event|IgPro20 (All Treated)|All subjects receiving at least 1 infusion of IgPro20
426096|NCT00543101|B3|Baseline|Total|Total of all reporting groups
426097|NCT00543101|B2|Baseline|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
426098|NCT00543101|B1|Baseline|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
426099|NCT00543101|P2|Participant Flow|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
426100|NCT00543101|P1|Participant Flow|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
426101|NCT00543101|O2|Outcome|Crossover Week 48|At week 24 the dual PI arm subjects remaining undetectable, crossed over to the DRV/r arm and were followed for an additional 24 weeks.
426102|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
426103|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
426104|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
426105|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
426106|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
426107|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
426108|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
426109|NCT00543101|E2|Reported Event|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
426110|NCT00543101|E1|Reported Event|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
426111|NCT00548691|B3|Baseline|Total|Total of all reporting groups
426112|NCT00548691|B2|Baseline|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
426113|NCT00548691|B1|Baseline|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
426114|NCT00548691|P2|Participant Flow|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
426115|NCT00548691|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
426116|NCT00548691|O2|Outcome|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
426117|NCT00548691|O1|Outcome|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
426118|NCT00548691|E2|Reported Event|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
426119|NCT00548691|E1|Reported Event|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
426120|NCT00548717|B3|Baseline|Total|Total of all reporting groups
426121|NCT00548717|B2|Baseline|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
426122|NCT00548717|B1|Baseline|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
426123|NCT00548717|P2|Participant Flow|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib for GVHD prophylaxis
Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF) Bortezomib (Velcade)
*Bortezomib added when study reopened in November 2012"
426124|NCT00548717|P1|Participant Flow|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis
Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF)"
426125|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
426126|NCT00548717|O1|Outcome|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
426127|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil,and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
426128|NCT00548717|O1|Outcome|Siro /MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
426129|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
426130|NCT00548717|O1|Outcome|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
426131|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
426132|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
426133|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
426134|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
426135|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
426136|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
426137|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) *added with study reopening in 2012"
426138|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
426139|NCT00548717|E1|Reported Event|Siro/MMF (+/- Bortezomib)|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis (+/- Bortezomib)
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
426140|NCT00548808|B3|Baseline|Total|Total of all reporting groups
426141|NCT00548808|B2|Baseline|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426142|NCT00548808|B1|Baseline|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426143|NCT00548808|P2|Participant Flow|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426144|NCT00548808|P1|Participant Flow|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426145|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426146|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426147|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426148|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426149|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426150|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426151|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426152|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426153|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426154|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426155|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426156|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426157|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426158|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426159|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426160|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426161|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426162|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426380|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426163|NCT00548808|E2|Reported Event|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
426164|NCT00548808|E1|Reported Event|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
426165|NCT00548847|B1|Baseline|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
426166|NCT00548847|P1|Participant Flow|GM-CSF, Interferon-α-2b|Granulocyte-macrophage colony-stimulating factor (GM-CSF), Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
426167|NCT00548847|O1|Outcome|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m² Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
426168|NCT00548847|O1|Outcome|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m² Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
426169|NCT00548847|E1|Reported Event|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
426170|NCT00548860|B3|Baseline|Total|Total of all reporting groups
426171|NCT00548860|B2|Baseline|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
426172|NCT00548860|B1|Baseline|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
426173|NCT00548860|P2|Participant Flow|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
426174|NCT00548860|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
426175|NCT00548860|O2|Outcome|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
426176|NCT00548860|O1|Outcome|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
426177|NCT00548860|E2|Reported Event|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
426178|NCT00548860|E1|Reported Event|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
426179|NCT00548886|B1|Baseline|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
426180|NCT00548886|P1|Participant Flow|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
426181|NCT00548886|O1|Outcome|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
426182|NCT00548886|E1|Reported Event|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
426183|NCT00549172|B3|Baseline|Total|Total of all reporting groups
426184|NCT00549172|B2|Baseline|Conservative (K)|"Arthroscopy (diagnostic)
Conservative (diagnostic arthroscopy): Diagnostic arthroscopy
n=76"
426185|NCT00549172|B1|Baseline|Operative (O)|"Partial resection of degenerative tear of medial meniscus
Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus
n=70"
426186|NCT00549172|P2|Participant Flow|Conservative (K)|"Arthroscopy (diagnostic)
Conservative (diagnostic arthroscopy): Diagnostic arthroscopy
n=76"
426187|NCT00549172|P1|Participant Flow|Operative (O)|"Partial resection of degenerative tear of medial meniscus
Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus
n=70"
426188|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)
Conservative (diagnostic arthroscopy): Diagnostic arthroscopy
n=76"
426189|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus
Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus
n=70"
426190|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)
Conservative (diagnostic arthroscopy): Diagnostic arthroscopy
n=76"
426191|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus
Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus
n=70"
426192|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)
Conservative (diagnostic arthroscopy): Diagnostic arthroscopy
n=76"
426193|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus
Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus
n=70"
426194|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)
Conservative (diagnostic arthroscopy): Diagnostic arthroscopy
n=76"
426195|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus
Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus
n=70"
426196|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)
Conservative (diagnostic arthroscopy): Diagnostic arthroscopy
n=76"
426197|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus
Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus
n=70"
426198|NCT00549172|E2|Reported Event|Conservative (K)|"Arthroscopy (diagnostic)
Conservative (diagnostic arthroscopy): Diagnostic arthroscopy"
426245|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426199|NCT00549172|E1|Reported Event|Operative (O)|"Partial resection of degenerative tear of medial meniscus
Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus"
426200|NCT00549198|B3|Baseline|Total|Total of all reporting groups
426201|NCT00549198|B2|Baseline|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426202|NCT00549198|B1|Baseline|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426203|NCT00549198|P2|Participant Flow|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426204|NCT00549198|P1|Participant Flow|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426205|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426206|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426207|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426208|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426209|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426210|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426211|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426212|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426213|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426214|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426215|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426216|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426217|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426218|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426219|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426220|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426221|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426222|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426223|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426224|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426225|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426226|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426227|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426228|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426229|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426230|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426231|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426232|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426233|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426234|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426235|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426236|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426237|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426238|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426239|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426240|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426241|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426242|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426243|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426244|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426246|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426247|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426248|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426249|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426250|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426251|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426252|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426253|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426254|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426255|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426256|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426257|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426258|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426259|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426260|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426261|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426262|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426263|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426264|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426265|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426266|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426267|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426268|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426269|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426270|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426271|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426272|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426273|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426274|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426275|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426276|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426277|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426278|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426279|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426280|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426281|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426282|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426283|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426284|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426285|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426286|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426287|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426288|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426289|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426290|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426291|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426292|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426293|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426294|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426295|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426296|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426297|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426298|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426299|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426300|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426301|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426302|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426303|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426304|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426305|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426306|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426307|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426308|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426309|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426310|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426311|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426312|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426313|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426314|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426315|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426316|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426317|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426318|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426319|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426320|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426321|NCT00549198|E2|Reported Event|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
426322|NCT00549198|E1|Reported Event|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
426323|NCT00549302|B3|Baseline|Total|Total of all reporting groups
426324|NCT00549302|B2|Baseline|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
426325|NCT00549302|B1|Baseline|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
426326|NCT00549302|P3|Participant Flow|Tadalafil 40 mg Open-Label|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Week 53 up to Week 243.
426327|NCT00549302|P2|Participant Flow|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
426328|NCT00549302|P1|Participant Flow|Tadalafil 20 mg Double Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
426329|NCT00549302|O2|Outcome|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
426330|NCT00549302|O1|Outcome|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
426331|NCT00549302|O2|Outcome|Tadalafil 40 mg|Tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment.
426332|NCT00549302|O1|Outcome|Tadalalfil 20 Milligrams (mg)|Tadalafil, 20 milligram (mg) tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment; LOCF.
426333|NCT00549302|O2|Outcome|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
426334|NCT00549302|O1|Outcome|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
439639|NCT00577135|O2|Outcome|Continuous Infusion|
426335|NCT00549302|O1|Outcome|Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label|Tadalafil 20 mg tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment or tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment in Double-blind period; and tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Week 53 up to Week 243 in Open-label period.
426336|NCT00549302|E1|Reported Event|Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label|Tadalafil 20 mg administered orally as 1 tadalafil 20-mg tablet and 1 matched placebo tablet, once daily from Day 1 up to 52 weeks of treatment, or tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Day 1 up to 52 weeks of treatment in Double-Blind Period; and tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Week 53 up to Week 243 in Open-Label Period.
426337|NCT00549328|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
426338|NCT00549328|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
426339|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
426340|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
426341|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
426342|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
426343|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
426344|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
426345|NCT00549328|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
426346|NCT00549393|B3|Baseline|Total|Total of all reporting groups
426347|NCT00549393|B2|Baseline|Control Arm|Standard bathing with soap and water basin or disposable cloth
426348|NCT00549393|B1|Baseline|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate
2% Chlorhexidine gluconate cloth: Daily bathing"
426349|NCT00549393|P2|Participant Flow|Standard Bath|Standard bathing with soap and water basin or disposable cloth
426350|NCT00549393|P1|Participant Flow|2% Chlorhexidine Gluconate Cloth|"Daily bathing with 2% chlorhexidine gluconate
2% Chlorhexidine gluconate cloth: Daily bathing"
426351|NCT00549393|O2|Outcome|Control|Standard bathing with soap and water basin or disposable cloth
426352|NCT00549393|O1|Outcome|Treatment|Daily bathing with 2% chlorhexidine gluconate
426353|NCT00549393|O2|Outcome|Control Arm|Standard bathing with soap and water basin or disposable cloth
426354|NCT00549393|O1|Outcome|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate
2% Chlorhexidine gluconate cloth: Daily bathing"
426355|NCT00549393|O2|Outcome|Control Arm|Standard bathing with soap and water basin or disposable cloth
426356|NCT00549393|O1|Outcome|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate
2% Chlorhexidine gluconate cloth: Daily bathing"
426357|NCT00549393|E2|Reported Event|Control Arm|Standard bathing with soap and water basin or disposable cloth
426358|NCT00549393|E1|Reported Event|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate
2% Chlorhexidine gluconate cloth: Daily bathing"
426359|NCT00549445|B3|Baseline|Total|Total of all reporting groups
426360|NCT00549445|B2|Baseline|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.
Placebo: Daily"
426361|NCT00549445|B1|Baseline|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.
Azithromycin: 250 mg daily"
426362|NCT00549445|P2|Participant Flow|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.
Placebo: Daily"
426363|NCT00549445|P1|Participant Flow|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.
Azithromycin: 250 mg daily"
426364|NCT00549445|O2|Outcome|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.
Placebo: Daily"
426365|NCT00549445|O1|Outcome|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.
Azithromycin: 250 mg daily"
426366|NCT00549445|E2|Reported Event|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.
Placebo: Daily"
426367|NCT00549445|E1|Reported Event|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.
Azithromycin: 250 mg daily"
426368|NCT00549549|B5|Baseline|Total|Total of all reporting groups
426369|NCT00549549|B4|Baseline|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426370|NCT00549549|B3|Baseline|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426371|NCT00549549|B2|Baseline|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426372|NCT00549549|B1|Baseline|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426373|NCT00549549|P4|Participant Flow|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426374|NCT00549549|P3|Participant Flow|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426375|NCT00549549|P2|Participant Flow|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426376|NCT00549549|P1|Participant Flow|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426377|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426378|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426379|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426381|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426382|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426383|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426384|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426385|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426386|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426387|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426388|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426389|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426390|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426391|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426392|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426393|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426394|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426395|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426396|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426397|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426398|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426399|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426400|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426401|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426402|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426403|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426404|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426405|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426406|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426407|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426408|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426409|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426410|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426411|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426412|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426413|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426414|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426415|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426416|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426417|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426418|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426419|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426420|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426421|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426422|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426792|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426793|NCT00550043|O1|Outcome|Placebo|
426423|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426424|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426425|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426426|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426427|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426428|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426429|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426430|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426431|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426432|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426433|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426434|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426435|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426436|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426437|NCT00549549|E4|Reported Event|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
426438|NCT00549549|E3|Reported Event|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
426439|NCT00549549|E2|Reported Event|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
426440|NCT00549549|E1|Reported Event|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
426441|NCT00549562|B1|Baseline|Paliperidone ER|"8-Week Open-Label
Paliperidone ER: starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
426442|NCT00549562|P1|Participant Flow|Paliperidone ER|"8-Week Open-Label
Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
426443|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label
Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
426444|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label
Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
426445|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label
Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
426446|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label
Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
426447|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label
Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
426448|NCT00549562|E1|Reported Event|Paliperidone ER|"8-Week Open-Label
Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
426449|NCT00549601|B4|Baseline|Total|Total of all reporting groups
426450|NCT00549601|B3|Baseline|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
426451|NCT00549601|B2|Baseline|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
426452|NCT00549601|B1|Baseline|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
426453|NCT00549601|P3|Participant Flow|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
426454|NCT00549601|P2|Participant Flow|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
426455|NCT00549601|P1|Participant Flow|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
426456|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
426457|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
426458|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
439640|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
426459|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
426460|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
426461|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
426462|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
426463|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
426464|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
426465|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
426466|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
426467|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
426468|NCT00549601|O2|Outcome|Rivastigmine 9.5 mg Patch|Rivastigmine transdermal patches at a constant dose: Application of one 9.5 mg patch every day for the whole treatment period.
426469|NCT00549601|O1|Outcome|Rivastigmine 4.6 mg/9.5 mg Patch|Rivastigmine transdermal patches at increasing doses: Application of one 4.6 mg patch every day for the first month of treatment and thereafter daily application of one 9.5 mg patch for the next two months.
426470|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
426471|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
426472|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
426473|NCT00549601|E3|Reported Event|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
426474|NCT00549601|E2|Reported Event|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
426475|NCT00549601|E1|Reported Event|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
426476|NCT00549640|B3|Baseline|Total|Total of all reporting groups
426477|NCT00549640|B2|Baseline|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
426478|NCT00549640|B1|Baseline|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
426479|NCT00549640|P2|Participant Flow|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
426480|NCT00549640|P1|Participant Flow|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
426481|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
426482|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
426483|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
426484|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
426485|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
426486|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
426487|NCT00549640|E2|Reported Event|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
426488|NCT00549640|E1|Reported Event|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
426489|NCT00549718|B5|Baseline|Total|Total of all reporting groups
426490|NCT00549718|B4|Baseline|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
426491|NCT00549718|B3|Baseline|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
426531|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426492|NCT00549718|B2|Baseline|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
426493|NCT00549718|B1|Baseline|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
426494|NCT00549718|P4|Participant Flow|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
426495|NCT00549718|P3|Participant Flow|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
426496|NCT00549718|P2|Participant Flow|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
426497|NCT00549718|P1|Participant Flow|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
426498|NCT00549718|O4|Outcome|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
426499|NCT00549718|O3|Outcome|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
426500|NCT00549718|O2|Outcome|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
426501|NCT00549718|O1|Outcome|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
426502|NCT00549718|O4|Outcome|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
426503|NCT00549718|O3|Outcome|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
426504|NCT00549718|O2|Outcome|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
426505|NCT00549718|O1|Outcome|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
426506|NCT00549718|E4|Reported Event|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
426507|NCT00549718|E3|Reported Event|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
426508|NCT00549718|E2|Reported Event|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
426509|NCT00549718|E1|Reported Event|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
426510|NCT00549757|B3|Baseline|Total|Total of all reporting groups
426511|NCT00549757|B2|Baseline|Placebo|"In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
426512|NCT00549757|B1|Baseline|Aliskiren|"In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
426513|NCT00549757|P2|Participant Flow|Placebo|"In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
426514|NCT00549757|P1|Participant Flow|Aliskiren|"In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
426515|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426516|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426517|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426518|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426519|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426520|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426521|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426522|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426523|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426524|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426525|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426526|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426527|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426528|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426529|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426530|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426613|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426532|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426533|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426534|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426535|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426536|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426537|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426538|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426539|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426540|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426541|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426542|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426543|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426544|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426545|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426546|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426547|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426548|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426549|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426550|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426551|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426552|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426553|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426554|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426787|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426788|NCT00550043|O1|Outcome|Placebo|
426555|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426556|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426557|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426558|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426559|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426560|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426561|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426562|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426563|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426564|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426565|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426566|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426567|NCT00549757|E4|Reported Event|Extension-phase: Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426568|NCT00549757|E3|Reported Event|Extension-phase: Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
426569|NCT00549757|E2|Reported Event|Core-phase: Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until final closure of the study.
426570|NCT00549757|E1|Reported Event|Core-phase: Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
426571|NCT00549770|B9|Baseline|Total|Total of all reporting groups
426572|NCT00549770|B8|Baseline|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426573|NCT00549770|B7|Baseline|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426574|NCT00549770|B6|Baseline|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426575|NCT00549770|B5|Baseline|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426789|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426576|NCT00549770|B4|Baseline|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426577|NCT00549770|B3|Baseline|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426578|NCT00549770|B2|Baseline|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426579|NCT00549770|B1|Baseline|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426580|NCT00549770|P8|Participant Flow|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426581|NCT00549770|P7|Participant Flow|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426582|NCT00549770|P6|Participant Flow|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426583|NCT00549770|P5|Participant Flow|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426584|NCT00549770|P4|Participant Flow|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426585|NCT00549770|P3|Participant Flow|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426586|NCT00549770|P2|Participant Flow|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426587|NCT00549770|P1|Participant Flow|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426588|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426589|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426590|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426591|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426592|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426593|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426594|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426595|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426596|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426597|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426598|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426599|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426600|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426601|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426602|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426603|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426604|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426605|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426606|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426607|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426608|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426609|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426610|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426611|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426612|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
439641|NCT00577135|O4|Outcome|High Intensification|
426614|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426615|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426616|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426617|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426618|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426619|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426620|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426621|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426622|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426623|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426624|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426625|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426626|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426627|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426628|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426629|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426630|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426631|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426632|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426633|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426634|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426635|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426636|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426637|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426638|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426639|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426640|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426641|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426642|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426643|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426644|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426645|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426646|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426647|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426648|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426649|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426650|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426651|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426652|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426653|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426654|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426655|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426656|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426657|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426658|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426659|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426660|NCT00549770|E8|Reported Event|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426661|NCT00549770|E7|Reported Event|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
426662|NCT00549770|E6|Reported Event|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426663|NCT00549770|E5|Reported Event|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426664|NCT00549770|E4|Reported Event|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426665|NCT00549770|E3|Reported Event|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426666|NCT00549770|E2|Reported Event|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426667|NCT00549770|E1|Reported Event|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
426668|NCT00549783|B3|Baseline|Total|Total of all reporting groups
426669|NCT00549783|B2|Baseline|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426670|NCT00549783|B1|Baseline|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426671|NCT00549783|P2|Participant Flow|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426672|NCT00549783|P1|Participant Flow|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426673|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426674|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426675|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426676|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426677|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426678|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426679|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426680|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426681|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426682|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426683|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426790|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426684|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426685|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426686|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426687|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426688|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426689|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426690|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426691|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426692|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426693|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426694|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426695|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426696|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426697|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426698|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426699|NCT00549783|E2|Reported Event|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426700|NCT00549783|E1|Reported Event|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
426701|NCT00549822|B1|Baseline|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently
Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
426702|NCT00549822|P1|Participant Flow|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently
Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
426703|NCT00549822|O1|Outcome|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently
Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
426704|NCT00549822|O1|Outcome|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently
Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
426705|NCT00549822|O1|Outcome|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently
Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
426706|NCT00549822|E1|Reported Event|Intermittent Letrozole Therapy|Letrozole 2.5mg: Intermittently
426707|NCT00549900|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
426708|NCT00549900|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
426709|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
426791|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426710|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
426711|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
426712|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
426713|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
426714|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
426715|NCT00549900|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
426716|NCT00549939|B4|Baseline|Total|Total of all reporting groups
426717|NCT00549939|B3|Baseline|Alfuzosin 0.2 mg/kg/Day|
426718|NCT00549939|B2|Baseline|Alfuzosin 0.1 mg/kg/Day|
426719|NCT00549939|B1|Baseline|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
426720|NCT00549939|P3|Participant Flow|Alfuzosin 0.2 mg/kg/Day|
426721|NCT00549939|P2|Participant Flow|Alfuzosin 0.1 mg/kg/Day|
426722|NCT00549939|P1|Participant Flow|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
426723|NCT00549939|O2|Outcome|Alfuzosin 0.2 mg/kg/Day|
426724|NCT00549939|O1|Outcome|Alfuzosin 0.1 mg/kg/Day|
426725|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
426726|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
426727|NCT00549939|O1|Outcome|Placebo|
426728|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
426729|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
426730|NCT00549939|O1|Outcome|Placebo|
426731|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
426732|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
426733|NCT00549939|O1|Outcome|Placebo|
426734|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
426735|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
426736|NCT00549939|O1|Outcome|Placebo|
426737|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
426738|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
426739|NCT00549939|O1|Outcome|Placebo|
426740|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
426741|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
426742|NCT00549939|O1|Outcome|Placebo|
426743|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
426744|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
426745|NCT00549939|O1|Outcome|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
426746|NCT00549939|E2|Reported Event|Alfuzosin 0.2 mg/kg/Day|
426747|NCT00549939|E1|Reported Event|Alfuzosin 0.1 mg/kg/Day|
426748|NCT00550043|B6|Baseline|Total|Total of all reporting groups
426749|NCT00550043|B5|Baseline|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426750|NCT00550043|B4|Baseline|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426751|NCT00550043|B3|Baseline|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426752|NCT00550043|B2|Baseline|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426753|NCT00550043|B1|Baseline|Placebo|
426754|NCT00550043|P5|Participant Flow|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426755|NCT00550043|P4|Participant Flow|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426756|NCT00550043|P3|Participant Flow|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426757|NCT00550043|P2|Participant Flow|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426758|NCT00550043|P1|Participant Flow|Placebo|
426759|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426760|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426761|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426762|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426763|NCT00550043|O1|Outcome|Placebo|
426764|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426765|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426766|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426767|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426768|NCT00550043|O1|Outcome|Placebo|
426769|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426770|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426771|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426772|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426773|NCT00550043|O1|Outcome|Placebo|
426774|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426775|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426776|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426777|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426778|NCT00550043|O1|Outcome|Placebo|
426779|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426780|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426781|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426782|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426783|NCT00550043|O1|Outcome|Placebo|
426784|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426785|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426786|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426794|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426795|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426796|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426797|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426798|NCT00550043|O1|Outcome|Placebo|
426799|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426800|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426801|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426802|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426803|NCT00550043|O1|Outcome|Placebo|
426804|NCT00550043|E5|Reported Event|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426805|NCT00550043|E4|Reported Event|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426806|NCT00550043|E3|Reported Event|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426807|NCT00550043|E2|Reported Event|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426808|NCT00550043|E1|Reported Event|Placebo|
426809|NCT00550147|B1|Baseline|OROS Methylphenidate and Quetiapine|All enrolled subjects start taking OROS methylphenidate. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. Therefore enters the OROS methylphenidate and quetiapine arm. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. 2 subjects were withdrawn from the study prior to visit 5, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm.
426810|NCT00550147|P1|Participant Flow|OROS Methylphenidate and Quetiapine|This is the Baseline Visit, immediately after enrollment and prior to taking any medication. All enrolled subjects start taking OROS methylphenidate until Visit 5. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study; 2 subjects were withdrawn from the study prior to visit 5. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm. Visit 10 is measured at the end of OROS MPH+Quetiapine treatment
426811|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with MPH+Quetiapine after Week 13
426812|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after week 4
426813|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
426814|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
426815|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH Monotherapy after Week 4
426816|NCT00550147|O1|Outcome|Baseline|Baseline scores at Study Entry
426817|NCT00550147|O3|Outcome|Visit 10 - MPH + Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
426818|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
426819|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
426820|NCT00550147|O3|Outcome|Visit 10 - MPH + Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
426821|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
426822|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
426823|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with combined MPH and quetiapine after Week 13
426824|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
426825|NCT00550147|O1|Outcome|Baseline|Baseline score at study entry
426826|NCT00550147|E1|Reported Event|OROS Methylphenidate and Quetiapine|All enrolled subjects start taking OROS methylphenidate. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. Therefore enters the OROS methylphenidate and quetiapine arm. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. 2 subjects were withdrawn from the study prior to visit 5, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm.
426827|NCT00550173|B4|Baseline|Total|Total of all reporting groups
426828|NCT00550173|B3|Baseline|Pemetrexed|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426829|NCT00550173|B2|Baseline|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426830|NCT00550173|B1|Baseline|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426831|NCT00550173|P3|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426832|NCT00550173|P2|Participant Flow|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
427105|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426833|NCT00550173|P1|Participant Flow|Pemetrexed + Erlotinib|Pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426834|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426835|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426836|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426837|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426838|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426839|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426840|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426841|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426842|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426843|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426844|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426845|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426846|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426847|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426848|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426849|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426850|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426851|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426852|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426853|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426854|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426855|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426856|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426857|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426858|NCT00550173|E3|Reported Event|Pemetrexed|Participants received pemetrexed 500 mg/m^2 of body surface area, administered by intravenous (IV) infusion on Day 1 of each 21 day cycle until progression or unacceptable toxicity developed up to 39 months.
426859|NCT00550173|E2|Reported Event|Erlotinib|Participants received erlotinib 150 mg, administered orally once daily in each 21 day cycle until disease progression or unacceptable toxicity developed up to 39 months.
426860|NCT00550173|E1|Reported Event|Pemetrexed + Erlotinib|Participants received pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21 day cycle until disease progression or unacceptable toxicity developed up to 39 months.
426889|NCT00550394|E2|Reported Event|Quetiapine and Topiramate|"Quetiapine and Topiramate
Quetiapine + Topiramate: Dosing Schedule and Titration of Quetiapine:
open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
426861|NCT00550277|B1|Baseline|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
426862|NCT00550277|P1|Participant Flow|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
426863|NCT00550277|O1|Outcome|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
426864|NCT00550277|E1|Reported Event|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
426865|NCT00550368|B3|Baseline|Total|Total of all reporting groups
426866|NCT00550368|B2|Baseline|H. Pylori Positive|Participants who tested H. pylori positive
426867|NCT00550368|B1|Baseline|H. Pylori Negative|Participants who tested negative for H. pylori infection.
426868|NCT00550368|P2|Participant Flow|H. Pylori Positive|Participants who tested H. pylori positive
426869|NCT00550368|P1|Participant Flow|H. Pylori Negative|Participants who tested negative for H. pylori infection.
426870|NCT00550368|O2|Outcome|H. Pylori Positive|Participants who tested H. pylori positive
426871|NCT00550368|O1|Outcome|H. Pylori Negative|Participants who tested negative for H. pylori infection.
426872|NCT00550368|O2|Outcome|H. Pylori Positive|Participants who tested H. pylori positive
426873|NCT00550368|O1|Outcome|H. Pylori Negative|Participants who tested negative for H. pylori infection.
426874|NCT00550368|E2|Reported Event|H. Pylori Positive|Participants who tested H. pylori positive
426875|NCT00550368|E1|Reported Event|H. Pylori Negative|Participants who tested negative for H. pylori infection.
426876|NCT00550394|B3|Baseline|Total|Total of all reporting groups
426877|NCT00550394|B2|Baseline|Quitiapine andTopiramate|"Quetiapine and Topiramate
Quetiapine andTopiramate: Dosing Schedule and Titration of Quetiapine:
open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
426878|NCT00550394|B1|Baseline|Quitiapine and Placebo|"Quetiapine and Placebo
quetiapine and placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
426879|NCT00550394|P2|Participant Flow|Quetiapine and Topiramate|"Quetiapine and Topiramate
Quetiapine and Topiramate: Dosing Schedule and Titration of Quetiapine:
open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
426880|NCT00550394|P1|Participant Flow|Quetiapine and Placebo|"Quetiapine and Placebo
quetiapine and placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
426881|NCT00550394|O2|Outcome|Quetiapine and Topiramate|Quetiapine and Topiramate
426882|NCT00550394|O1|Outcome|Quetiapine and Placebo|Quetiapine and Placebo
426883|NCT00550394|O2|Outcome|Quetiapine and Topiramate|Quetiapine and Topiramate
426884|NCT00550394|O1|Outcome|Quetiapine and Placebo|Quetiapine and Placebo
426885|NCT00550394|O2|Outcome|Quetiapine and Topiramate|Quetiapine and Topiramate
426886|NCT00550394|O1|Outcome|Quetiapine and Placebo|Quetiapine and Placebo
426887|NCT00550394|O2|Outcome|Quetiapine + Topiramate|"Quetiapine + Topiramate
Quetiapine + Topiramate: Dosing Schedule and Titration of Quetiapine:
open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
426888|NCT00550394|O1|Outcome|Quetiapine + Placebo|"Quetiapine + Placebo
quetiapine + placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
426954|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427381|NCT00550459|P1|Participant Flow|Placebo|Placebo tablet given once daily for 21 days
426890|NCT00550394|E1|Reported Event|Quetiapine and Placebo|"Quetiapine and Placebo
quetiapine + placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
426891|NCT00550407|B3|Baseline|Total|Total of all reporting groups
426892|NCT00550407|B2|Baseline|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426893|NCT00550407|B1|Baseline|Placebo|Matching placebo
426894|NCT00550407|P3|Participant Flow|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426895|NCT00550407|P2|Participant Flow|Placebo|Matching placebo
426896|NCT00550407|P1|Participant Flow|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426897|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426898|NCT00550407|O1|Outcome|Placebo|Matching placebo
426899|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426900|NCT00550407|O1|Outcome|Placebo|Matching placebo
426901|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426902|NCT00550407|O1|Outcome|Placebo|Matching placebo
426903|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426904|NCT00550407|O1|Outcome|Placebo|Matching placebo
426905|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426906|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426907|NCT00550407|O1|Outcome|Placebo|Matching placebo
426908|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426909|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426910|NCT00550407|O1|Outcome|Placebo|Matching placebo
426911|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426912|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426913|NCT00550407|O1|Outcome|Placebo|Matching placebo
426914|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426915|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426916|NCT00550407|O1|Outcome|Placebo|Matching placebo
426917|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426918|NCT00550407|O1|Outcome|Placebo|Matching placebo
426919|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426920|NCT00550407|O1|Outcome|Placebo|Matching placebo
426921|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426922|NCT00550407|O1|Outcome|Placebo|Matching placebo
426923|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426924|NCT00550407|O1|Outcome|Placebo|Matching placebo
426925|NCT00550407|E3|Reported Event|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426926|NCT00550407|E2|Reported Event|Placebo|Matching placebo
426927|NCT00550407|E1|Reported Event|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426928|NCT00550446|B8|Baseline|Total|Total of all reporting groups
426929|NCT00550446|B7|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426930|NCT00550446|B6|Baseline|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426931|NCT00550446|B5|Baseline|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426932|NCT00550446|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426933|NCT00550446|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426934|NCT00550446|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426935|NCT00550446|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426936|NCT00550446|P11|Participant Flow|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426937|NCT00550446|P10|Participant Flow|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426938|NCT00550446|P9|Participant Flow|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426939|NCT00550446|P8|Participant Flow|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426940|NCT00550446|P7|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426941|NCT00550446|P6|Participant Flow|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426942|NCT00550446|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426943|NCT00550446|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426944|NCT00550446|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426945|NCT00550446|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426946|NCT00550446|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426947|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426948|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426949|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426950|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426951|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426952|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426953|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426955|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426956|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426957|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426958|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426959|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426960|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426961|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426962|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426963|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426964|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426965|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426966|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426967|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426968|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426969|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426970|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426971|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426972|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426973|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426974|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426975|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426976|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426977|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426978|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427003|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426979|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426980|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426981|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426982|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426983|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426984|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426985|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426986|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426987|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426988|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426989|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426990|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426991|NCT00550446|O10|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426992|NCT00550446|O9|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426993|NCT00550446|O8|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426994|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426995|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426996|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426997|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426998|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426999|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427000|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427001|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427002|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427382|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427004|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427005|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427006|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427007|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427008|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427009|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427010|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427011|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427012|NCT00550446|O10|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427013|NCT00550446|O9|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427014|NCT00550446|O8|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427015|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427016|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427017|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427018|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427019|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427020|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427021|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427022|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427023|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427024|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427025|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427026|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427027|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427028|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427029|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427030|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427031|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427032|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427033|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427034|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427035|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427036|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427037|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427038|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427039|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427040|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427041|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427042|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427043|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427044|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427045|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427046|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427047|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427048|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427049|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427050|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427051|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427052|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427053|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427103|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
439642|NCT00577135|O3|Outcome|Low Intensification|
427054|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427055|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427056|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427057|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427058|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427059|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427060|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427061|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427062|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427063|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427064|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427065|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427066|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427067|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427068|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427069|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427070|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427071|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427072|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427073|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427074|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427075|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427076|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427077|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427104|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
439643|NCT00577135|O2|Outcome|Continuous Infusion|
427078|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427079|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427080|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427081|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427082|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427083|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427084|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427085|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427086|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427087|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427088|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427089|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427090|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427091|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427092|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427093|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427094|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427095|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427096|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427097|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427098|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427099|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427100|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427101|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427102|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427106|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427107|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427108|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427109|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427110|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427111|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427112|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427113|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427114|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427115|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427116|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427117|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427118|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427119|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427120|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427121|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427122|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427123|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427124|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427125|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427126|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427127|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427128|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427129|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427130|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427131|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427132|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427133|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427134|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427135|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427136|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427137|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427138|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427139|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427140|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427141|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427142|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427143|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427144|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427145|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Participants who administered Adalimumab initially were switched to CP-690,550 5 milligram (mg) tablet from Week 12 to Week 24.
427146|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427147|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427148|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427149|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427150|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427151|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427152|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427153|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427154|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427383|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427384|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427155|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427156|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427157|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427158|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427159|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427160|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427161|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427162|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427163|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427164|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427165|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427166|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427167|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427168|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427169|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427170|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427171|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427172|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427173|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427174|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427175|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427176|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427177|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427178|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427179|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427180|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427181|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427182|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427183|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427184|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427185|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427186|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427187|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427188|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427189|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427190|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427191|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427192|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427193|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427194|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427195|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427196|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427197|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427198|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427199|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427200|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427201|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427202|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427203|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427204|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427205|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427206|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427207|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427208|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427209|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427210|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427211|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427212|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427213|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427214|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427215|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427216|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427217|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427218|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427219|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427220|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427221|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427222|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427223|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427224|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427225|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427226|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427227|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427228|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427229|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427278|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427230|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427231|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427232|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427233|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427234|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427235|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427236|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427237|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427238|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427239|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427240|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427241|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427242|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427243|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427244|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427245|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427246|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427247|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427248|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427249|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427250|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427251|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427252|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427253|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427279|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
439644|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
427254|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427255|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427256|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427257|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427258|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427259|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427260|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427261|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427262|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427263|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427264|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427265|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427266|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427267|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427268|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427269|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 10 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
427270|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427271|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Initially CP-690,550 3 mg tablet administered orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10. After Week 12, participants were reassigned CP-690,550 5 mg tablet administered orally twice daily.
427272|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427273|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427274|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427275|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427276|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427277|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427280|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427281|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427282|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427283|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427284|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427285|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427286|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427287|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427288|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427289|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427290|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427291|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427292|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427293|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427294|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427295|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427296|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427297|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427298|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427299|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427300|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427301|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427302|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427303|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 5 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
427304|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427378|NCT00550459|B2|Baseline|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427305|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427306|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427307|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427308|NCT00550446|O7|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427309|NCT00550446|O6|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427310|NCT00550446|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427311|NCT00550446|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427312|NCT00550446|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427313|NCT00550446|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427314|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427315|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427316|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427317|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427318|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427319|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427320|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427321|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427322|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427323|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427324|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427325|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427326|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427327|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427379|NCT00550459|B1|Baseline|Placebo|Placebo tablet given once daily for 21 days
427385|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427328|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427329|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427330|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 15 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
427331|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427332|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427333|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427334|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427335|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427336|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427337|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427338|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427339|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427340|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427341|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427342|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427343|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427344|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427345|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427346|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427347|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427348|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427349|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427350|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427351|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427352|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427380|NCT00550459|P2|Participant Flow|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427353|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427354|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427355|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427356|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427357|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427358|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427359|NCT00550446|O7|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427360|NCT00550446|O6|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427361|NCT00550446|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427362|NCT00550446|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427363|NCT00550446|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427364|NCT00550446|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427365|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427366|NCT00550446|E11|Reported Event|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427367|NCT00550446|E10|Reported Event|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
427368|NCT00550446|E9|Reported Event|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in Adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427369|NCT00550446|E8|Reported Event|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
427370|NCT00550446|E7|Reported Event|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427371|NCT00550446|E6|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427372|NCT00550446|E5|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
427373|NCT00550446|E4|Reported Event|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427374|NCT00550446|E3|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
427375|NCT00550446|E2|Reported Event|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427376|NCT00550446|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427377|NCT00550459|B3|Baseline|Total|Total of all reporting groups
427386|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427387|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427388|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427389|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427390|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427391|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427392|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427393|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427394|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427395|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427396|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427397|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427398|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427399|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427400|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427401|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427402|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427403|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427404|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427405|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427406|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427407|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427408|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427409|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427410|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427411|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427412|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427413|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427414|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427415|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427416|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427417|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427418|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427419|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427420|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427421|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427422|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427423|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427424|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427425|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427426|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427427|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427428|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427429|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427430|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427431|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427432|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427433|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427434|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427435|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427436|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427437|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427438|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427439|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
427440|NCT00550459|E2|Reported Event|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
427441|NCT00550459|E1|Reported Event|Placebo|Placebo tablet given once daily for 21 days
427442|NCT00550537|B1|Baseline|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427443|NCT00550537|P1|Participant Flow|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
439645|NCT00577135|O4|Outcome|High Intensification|
427444|NCT00550537|O3|Outcome|Erlotinib|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427445|NCT00550537|O2|Outcome|Erlotinib Followed by PC+B|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427446|NCT00550537|O1|Outcome|Erlotinib Followed by PC|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427447|NCT00550537|O1|Outcome|Erlotinib Segament|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427448|NCT00550537|O1|Outcome|Patients on Erlotinib Segament|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427449|NCT00550537|O1|Outcome|Patients on Erlotinib Segament|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427450|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427451|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427452|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427453|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427454|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427493|NCT00550680|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
428081|NCT00554099|E1|Reported Event|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
427455|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427456|NCT00550537|E1|Reported Event|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
bevacizumab: 15 mg/m2 given through a vein for every 3 weeks
carboplatin: AUC = 6 given through a vein on day 1 of each cycle.
erlotinib hydrochloride: 150 mg taken by mouth daily
paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.
gene expression analysis: Blood and tissue collection.
protein expression analysis: Blood and tissue collection.
proteomic profiling: Blood and tissue collection.
laboratory biomarker analysis: Blood and tissue collection."
427457|NCT00550550|B3|Baseline|Total|Total of all reporting groups
427458|NCT00550550|B2|Baseline|Placebo|Matching placebo tablet administered sublingually once daily.
427459|NCT00550550|B1|Baseline|SCH 697243|SCH 697243 (Phleum pratense extract) administered sublingually once daily.
427460|NCT00550550|P2|Participant Flow|Placebo|Matching placebo tablet administered sublingually once daily.
427461|NCT00550550|P1|Participant Flow|SCH 697243|SCH 697243 (Phleum pratense extract) administered sublingually once daily.
427462|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
427463|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
427464|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
427465|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
427466|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
427467|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
427468|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
427469|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
427470|NCT00550550|E2|Reported Event|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
427471|NCT00550550|E1|Reported Event|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
427472|NCT00550589|B1|Baseline|Cidofovir|1.0% topical cidofovir cream
427473|NCT00550589|P1|Participant Flow|Cidofovir|1.0% topical cidofovir cream
427474|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
427475|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
427476|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
427477|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
427478|NCT00550589|O1|Outcome|Cidofovir|"1.0% topical cidofovir cream
cidofovir: 1.0% topical cream self-applied once daily for 5 consecutive days, with no treatment for the remaining 9 days (a treatment cycle). Subjects will receive up to 6 cycles of treatment.
DNA methylation analysis: formalin fixed biopsy collected at baseline and 6 weeks after treatment discontinuation
gene expression analysis: punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation
polymerase chain reaction: performed on punch biopsy specimens collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation
biopsy: punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation
histopathologic examination: Evaluated at baseline and 6 weeks after treatment discontinuation"
427479|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
427480|NCT00550589|O1|Outcome|Cidofovir|1% cidofovir
427481|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
427482|NCT00550589|E1|Reported Event|Cidofovir|1.0% topical cidofovir cream
427483|NCT00550654|B1|Baseline|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
427484|NCT00550654|P1|Participant Flow|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
427485|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
427486|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
427487|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
427488|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
427489|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
427490|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
427491|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
427492|NCT00550654|E1|Reported Event|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
427518|NCT00550745|O2|Outcome|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
427494|NCT00550680|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
427495|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
427496|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
427497|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
427498|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
427499|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
427500|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
427501|NCT00550680|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
427502|NCT00550732|B1|Baseline|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
427503|NCT00550732|P1|Participant Flow|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
427504|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
427505|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
427506|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
427507|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
427508|NCT00550732|O1|Outcome|Prosaconazole|Posaconazole oral suspension was administered as 400 mg BID with food or 200 mg QID without food for a minimum of one month.
427509|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
427510|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
427511|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
427512|NCT00550732|E1|Reported Event|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
427513|NCT00550745|B3|Baseline|Total|Total of all reporting groups
427514|NCT00550745|B2|Baseline|Placebo|"Represents the number of subjects according to the treatment (placebo) received.
Excludes subjects who were not vaccinated."
427515|NCT00550745|B1|Baseline|ZOSTAVAX™|"Represents the number of subjects according to the treatment (ZOSTAVAX™) received.
Excludes subjects who were not vaccinated."
427516|NCT00550745|P2|Participant Flow|Placebo|Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
427517|NCT00550745|P1|Participant Flow|ZOSTAVAX™|Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
428082|NCT00554190|B1|Baseline|AdvaCoat and Merogel Injectable|AdvaCoat compared with Merogel Injectable
427519|NCT00550745|O1|Outcome|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™) and had safety follow-up.
427520|NCT00550745|O2|Outcome|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
427521|NCT00550745|O1|Outcome|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™) and had safety follow-up.
427522|NCT00550745|E2|Reported Event|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
427523|NCT00550745|E1|Reported Event|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (Zostavax™) and had safety follow-up.
427524|NCT00550771|B3|Baseline|Total|Total of all reporting groups
427525|NCT00550771|B2|Baseline|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
427526|NCT00550771|B1|Baseline|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
427527|NCT00550771|P2|Participant Flow|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
427528|NCT00550771|P1|Participant Flow|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
427529|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
427530|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
427531|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
427532|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
427533|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
427534|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
427535|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
427536|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
427537|NCT00550771|E2|Reported Event|Doxorubicin Based Regimen|
427538|NCT00550771|E1|Reported Event|PLD Based Regimen|
427539|NCT00550836|B3|Baseline|Total|Total of all reporting groups
427540|NCT00550836|B2|Baseline|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
427541|NCT00550836|B1|Baseline|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
428171|NCT00554515|O1|Outcome|Clear Cell Tumor Type|
427542|NCT00550836|P2|Participant Flow|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
427543|NCT00550836|P1|Participant Flow|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
427544|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
427545|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
427546|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
427547|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
427548|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
427549|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
427550|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
427551|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
427552|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
427608|NCT00551031|B2|Baseline|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
439646|NCT00577135|O3|Outcome|Low Intensification|
427553|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
427554|NCT00550836|E2|Reported Event|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
427555|NCT00550836|E1|Reported Event|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
427556|NCT00550862|B5|Baseline|Total|Total of all reporting groups
427557|NCT00550862|B4|Baseline|Placebo|
427558|NCT00550862|B3|Baseline|INT-747 50 mg|
427559|NCT00550862|B2|Baseline|INT-747 25 mg|
427560|NCT00550862|B1|Baseline|INT-747 10 mg|
427561|NCT00550862|P4|Participant Flow|Placebo|
427562|NCT00550862|P3|Participant Flow|INT-747 50 mg|
427563|NCT00550862|P2|Participant Flow|INT-747 25 mg|
427564|NCT00550862|P1|Participant Flow|INT-747 10 mg|
427565|NCT00550862|O4|Outcome|Placebo|
427566|NCT00550862|O3|Outcome|INT-747 50 mg|
427567|NCT00550862|O2|Outcome|INT-747 25 mg|
427568|NCT00550862|O1|Outcome|INT-747 10 mg|
427569|NCT00550862|O4|Outcome|Placebo|
427570|NCT00550862|O3|Outcome|INT-747 50 mg|
427571|NCT00550862|O2|Outcome|INT-747 25 mg|
427572|NCT00550862|O1|Outcome|INT-747 10 mg|
427573|NCT00550862|O4|Outcome|Placebo|
427574|NCT00550862|O3|Outcome|INT-747 50 mg|
427575|NCT00550862|O2|Outcome|INT-747 25 mg|
427576|NCT00550862|O1|Outcome|INT-747 10 mg|
427577|NCT00550862|E4|Reported Event|Placebo|
427578|NCT00550862|E3|Reported Event|INT-747 50 mg|
427579|NCT00550862|E2|Reported Event|INT-747 25 mg|
427580|NCT00550862|E1|Reported Event|INT-747 10 mg|
427581|NCT00550953|B3|Baseline|Total|Total of all reporting groups
427582|NCT00550953|B2|Baseline|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
427583|NCT00550953|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
427584|NCT00550953|P2|Participant Flow|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
427585|NCT00550953|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
427586|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
427587|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
427588|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
427589|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
427590|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
427591|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
427592|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
427593|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
427594|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
427595|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
427596|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
427597|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
427598|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
427599|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
427600|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
427601|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
427602|NCT00550953|E2|Reported Event|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
427603|NCT00550953|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
427604|NCT00551031|B6|Baseline|Total|Total of all reporting groups
427605|NCT00551031|B5|Baseline|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427606|NCT00551031|B4|Baseline|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
427607|NCT00551031|B3|Baseline|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
439647|NCT00577135|O2|Outcome|Continuous Infusion|
427609|NCT00551031|B1|Baseline|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427610|NCT00551031|P5|Participant Flow|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427611|NCT00551031|P4|Participant Flow|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
427612|NCT00551031|P3|Participant Flow|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427613|NCT00551031|P2|Participant Flow|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427614|NCT00551031|P1|Participant Flow|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427615|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427616|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
427617|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427618|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427619|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427620|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427621|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
427622|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427623|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427624|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427625|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427626|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
427627|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427628|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427629|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427630|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427631|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
427632|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427633|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427634|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427635|NCT00551031|E5|Reported Event|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427636|NCT00551031|E4|Reported Event|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
427637|NCT00551031|E3|Reported Event|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
427638|NCT00551031|E2|Reported Event|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427639|NCT00551031|E1|Reported Event|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
427640|NCT00551070|B1|Baseline|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
427641|NCT00551070|P1|Participant Flow|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
427642|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
427643|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
427644|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
427645|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
427646|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
427647|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
428952|NCT00555750|E1|Reported Event|Active|active medication administration nightly before bed
427648|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
427649|NCT00551070|E1|Reported Event|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
427650|NCT00551135|B5|Baseline|Total|Total of all reporting groups
427651|NCT00551135|B4|Baseline|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427652|NCT00551135|B3|Baseline|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427653|NCT00551135|B2|Baseline|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427654|NCT00551135|B1|Baseline|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427655|NCT00551135|P4|Participant Flow|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427656|NCT00551135|P3|Participant Flow|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427657|NCT00551135|P2|Participant Flow|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427658|NCT00551135|P1|Participant Flow|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427659|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427660|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427661|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427662|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427663|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427664|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427665|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427666|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427667|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427668|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427669|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427670|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427671|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427672|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427855|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427673|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427674|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427675|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427676|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427677|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427678|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427679|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427680|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427681|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427682|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427683|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427684|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427685|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427686|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427687|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427688|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427689|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427690|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427691|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427692|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427693|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427694|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427695|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427696|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427697|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427698|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427699|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427700|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427701|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427702|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427703|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427704|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427705|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427706|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427707|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427708|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427709|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427710|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427711|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427712|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427713|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427714|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427715|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427716|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427717|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427718|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427719|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427720|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427721|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427722|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427723|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427724|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427725|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427726|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427727|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427728|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427729|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427730|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427731|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427732|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427733|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427734|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427735|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427736|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427737|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427738|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427739|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427740|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427741|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427742|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427743|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427744|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427745|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427746|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427747|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427748|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427749|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427750|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427751|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427752|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427753|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427754|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427755|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427756|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427757|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427758|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427759|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427760|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427761|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427762|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427763|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427764|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427765|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427766|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427767|NCT00551135|E4|Reported Event|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
427768|NCT00551135|E3|Reported Event|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
427769|NCT00551135|E2|Reported Event|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
427770|NCT00551135|E1|Reported Event|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
427771|NCT00551161|B1|Baseline|Single-arm|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
427772|NCT00551161|P1|Participant Flow|Memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
427773|NCT00551161|O1|Outcome|Memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
427774|NCT00551161|E1|Reported Event|Single-arm|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
427775|NCT00551174|B3|Baseline|Total|Total of all reporting groups
427776|NCT00551174|B2|Baseline|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
427777|NCT00551174|B1|Baseline|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
427778|NCT00551174|P2|Participant Flow|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
427779|NCT00551174|P1|Participant Flow|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
427780|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
427781|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
427782|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
427783|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
427784|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
427785|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
427786|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
427787|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
427788|NCT00551174|E2|Reported Event|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
427789|NCT00551174|E1|Reported Event|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
427790|NCT00551200|B1|Baseline|Buphenyl to HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
427791|NCT00551200|P1|Participant Flow|Buphenyl to HPN-100|HPN-100 : Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study, and then switched over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 was increased and the dose of Buphenyl® was decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate was HPN-100. Target HPN-100 dose contained the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week and then switched back to previous dose of Buphenyl for the last week of the study.
427792|NCT00551200|O2|Outcome|HPN-100|HPN-100 dose contained the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week to reach steady state before blood sample collection.
427793|NCT00551200|O1|Outcome|Buphenyl|Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study before blood sample collection.
427794|NCT00551200|O2|Outcome|HPN-100|HPN-100 dose contained the same amount of phenylbutyrates as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week to reach steady state before blood sample collection.
427795|NCT00551200|O1|Outcome|Buphenyl|Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study before blood sample collection.
427796|NCT00551200|O1|Outcome|Buphenyl to HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
428953|NCT00555880|B3|Baseline|Total|Total of all reporting groups
427797|NCT00551200|O2|Outcome|HPN-100 Steady State|After dose escalation to full dose of HPN-100 was completed, subjects received only HPN-100 for 1 week (and achieved steady state) prior to switching back to their original NaPBA treatment.
427798|NCT00551200|O1|Outcome|NaPBA Steady State|Subjects were on NaPBA TID treatment for at least 2 weeks prior to enrollment, and were thus expected to be at steady-state levels prior to enrollment. After enrollment, subjects received 1 week of NaPBA treatment before switching over to HPN-100 dose escalation phase.
427799|NCT00551200|O2|Outcome|HPN-100 Steady State|After dose escalation to full dose of HPN-100 was completed, subjects received only HPN-100 for 1 week (and achieved steady state) prior to switching back to their original NaPBA treatment.
427800|NCT00551200|O1|Outcome|NaPBA Steady State|Subjects were on NaPBA TID treatment for at least 2 weeks prior to enrollment, and were thus expected to be at steady-state levels prior to enrollment. After enrollment, subjects received 1 week of NaPBA treatment before switching over to HPN-100 dose escalation phase.
427801|NCT00551200|E2|Reported Event|HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
427802|NCT00551200|E1|Reported Event|Buphenyl|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
427803|NCT00551213|B3|Baseline|Total|Total of all reporting groups
427804|NCT00551213|B2|Baseline|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427805|NCT00551213|B1|Baseline|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427806|NCT00551213|P2|Participant Flow|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427807|NCT00551213|P1|Participant Flow|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg intravenously (IV) followed by 1 dose of robatumumab 10 mg/kg IV once every 2 weeks (Q2W) until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427808|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427809|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427810|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427811|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427812|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427813|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427814|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427815|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427816|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427817|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427818|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427819|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427820|NCT00551213|E2|Reported Event|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427821|NCT00551213|E1|Reported Event|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
427822|NCT00551291|B1|Baseline|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
Mycophenolate mofetil: 1 gm twice daily orally until end of study.
Prednisone: 10 mg/day orally until end of study.
Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
427823|NCT00551291|P1|Participant Flow|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
Mycophenolate mofetil: 1 gm twice daily orally until end of study.
Prednisone: 10 mg/day orally until end of study.
Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
427824|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
Mycophenolate mofetil: 1 gm twice daily orally until end of study.
Prednisone: 10 mg/day orally until end of study.
Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
427825|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
Mycophenolate mofetil: 1 gm twice daily orally until end of study.
Prednisone: 10 mg/day orally until end of study.
Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
427826|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
Mycophenolate mofetil: 1 gm twice daily orally until end of study.
Prednisone: 10 mg/day orally until end of study.
Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
427827|NCT00551291|E1|Reported Event|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
Mycophenolate mofetil: 1 gm twice daily orally until end of study.
Prednisone: 10 mg/day orally until end of study.
Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
427828|NCT00551369|B1|Baseline|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
427829|NCT00551369|P1|Participant Flow|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
427830|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
427831|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
427832|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
427833|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
427834|NCT00551369|E1|Reported Event|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
427835|NCT00551421|B1|Baseline|Pertuzumab and Cetuximab|Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
427909|NCT00551746|O2|Outcome|Placebo|Taste, color, and colorically matched grape juice placebo
427836|NCT00551421|P1|Participant Flow|Pertuzumab and Cetuximab|"Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
Given IV: irinotecan hydrochloride, pertuzumab, cetuximab
Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method"
427837|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
pertuzumab: Given IV
cetuximab: Given IV
irinotecan hydrochloride: Given IV
immunohistochemistry staining method: Correlative study
fluorescence in situ hybridization: Correlative study
gene expression analysis: Correlative study
mutation analysis: Correlative study
polymerase chain reaction: Correlative study
laboratory biomarker analysis: Correlative study"
427838|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
pertuzumab: Given IV
cetuximab: Given IV
irinotecan hydrochloride: Given IV
immunohistochemistry staining method: Correlative study
fluorescence in situ hybridization: Correlative study
gene expression analysis: Correlative study
mutation analysis: Correlative study
polymerase chain reaction: Correlative study
laboratory biomarker analysis: Correlative study"
427839|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
pertuzumab: Given IV
cetuximab: Given IV
irinotecan hydrochloride: Given IV
immunohistochemistry staining method: Correlative study
fluorescence in situ hybridization: Correlative study
gene expression analysis: Correlative study
mutation analysis: Correlative study
polymerase chain reaction: Correlative study
laboratory biomarker analysis: Correlative study"
427840|NCT00551421|O1|Outcome|Pertuzumab and Cetuximab|"Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
Given IV: irinotecan hydrochloride, pertuzumab, cetuximab
Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method"
427841|NCT00551421|E1|Reported Event|Pertuzumab and Cetuximab|"Original Protocol: Patients received pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose on cycle 1, day 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Amended Protocol, Phase I: Same as the Original Protocol (see above) except the Cetuximab loading dose was no longer given on cycle 1, day 2 (maintainance dose given).
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
Given IV: pertuzumab, cetuximab, irinotecan hydrochloride
Corrlateive studies: immunohistochemistry staining method, fluorescence in situ hybridization, gene expression analysis, mutation analysis, polymerase chain reaction, laboratory biomarker analysis"
427842|NCT00551525|B1|Baseline|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
427843|NCT00551525|P1|Participant Flow|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
427844|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
427845|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
427846|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
427847|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
427848|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
427849|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
427850|NCT00551525|E1|Reported Event|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
427851|NCT00546052|B1|Baseline|Losartan +/- Hydrochlorothiazide|Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
427852|NCT00546052|P1|Participant Flow|Losartan +/- Hydrochlorothiazide|Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
427853|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427854|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427856|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427857|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427858|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427859|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427860|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427861|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427862|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427863|NCT00546052|O3|Outcome|Overall Per Protocol|All patients completing the 52 week study follow up.
427864|NCT00546052|O2|Outcome|Overall Intend to Treat|All patients enrolled and receiving at least one dose of study drug and having at least one follow up visit.
427865|NCT00546052|O1|Outcome|Overall Total|All patients enrolled (signed the informed consent).
427866|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427867|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
427868|NCT00546052|E1|Reported Event|Overall ITT|
427869|NCT00551642|B3|Baseline|Total|Total of all reporting groups
427870|NCT00551642|B2|Baseline|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
427871|NCT00551642|B1|Baseline|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
427872|NCT00551642|P2|Participant Flow|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
427873|NCT00551642|P1|Participant Flow|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
427874|NCT00551642|O2|Outcome|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
427875|NCT00551642|O1|Outcome|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
427876|NCT00551642|E2|Reported Event|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
427877|NCT00551642|E1|Reported Event|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
427878|NCT00551707|B6|Baseline|Total|Total of all reporting groups
427879|NCT00551707|B5|Baseline|Placebo|"placebo
placebo: placebo"
427880|NCT00551707|B4|Baseline|Dipyridamole|"dipyridamole
dipyridamole: dipyridamole (180 mg or 360 mg)"
427881|NCT00551707|B3|Baseline|Prednisolone|"prednisolone
prednisolone: prednisolone (2.7 mg)"
427882|NCT00551707|B2|Baseline|CRx-102 (2.7/360)|"Crx-102 (Dose 2)
2.7 mg prednisolone plus 360 mg dipyridamole"
427883|NCT00551707|B1|Baseline|CRx-102 (2.7/180)|Crx-102 (Dose 1) 2.7 mg prednisolone plus 180 mg dipyridamole
427884|NCT00551707|P5|Participant Flow|Placebo|"placebo
placebo: placebo"
427885|NCT00551707|P4|Participant Flow|Dipyridamole|"dipyridamole
dipyridamole: dipyridamole (360 mg)"
427886|NCT00551707|P3|Participant Flow|Prednisolone|"prednisolone
prednisolone: prednisolone (2.7 mg)"
427887|NCT00551707|P2|Participant Flow|CRx-102 (2.7/360)|"Crx-102 (Dose 2)
2.7 mg prednisolone plus 360 mg dipyridamole"
427888|NCT00551707|P1|Participant Flow|CRx-102 (2.7/180)|CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
427889|NCT00551707|O5|Outcome|Placebo|"placebo
placebo: placebo"
427890|NCT00551707|O4|Outcome|Dipyridamole|"dipyridamole
dipyridamole: dipyridamole 360 mg"
427891|NCT00551707|O3|Outcome|Prednisolone|"prednisolone
prednisolone: prednisolone (2.7 mg)"
427892|NCT00551707|O2|Outcome|CRx-102 (2.7/360)|"Crx-102 (Dose 2)
2.7 mg prednisolone plus 360 mg dipyridamole"
427893|NCT00551707|O1|Outcome|CRx-102 (2.7/180)|"Crx-102 (Dose 1)
2.7 mg prednisolone plus 180 mg dipyridamole"
427894|NCT00551707|O5|Outcome|Placebo|"placebo
placebo: placebo"
427895|NCT00551707|O4|Outcome|Dipyridamole|"dipyridamole
dipyridamole: dipyridamole (360 mg)"
427896|NCT00551707|O3|Outcome|Prednisolone|"prednisolone
prednisolone: prednisolone (2.7 mg)"
427897|NCT00551707|O2|Outcome|CRx-102 (2.7/360)|"Crx-102 (Dose 2)
2.7 mg prednisolone plus 360 mg dipyridamole"
427898|NCT00551707|O1|Outcome|CRx-102 (2.7/180)|CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
427899|NCT00551707|E5|Reported Event|Placebo|"placebo
placebo: placebo"
427900|NCT00551707|E4|Reported Event|Dipyridamole|"dipyridamole
dipyridamole: dipyridamole (180 mg or 360 mg)"
427901|NCT00551707|E3|Reported Event|Prednisolone|"prednisolone
prednisolone: prednisolone (2.7 mg)"
427902|NCT00551707|E2|Reported Event|CRx-102 (Dose 2)|"Crx-102 (Dose 2)
CRx-102: prednisolone + dipyridamole"
427903|NCT00551707|E1|Reported Event|CRx-102 (Dose 1)|"Crx-102 (Dose 1)
CRx-102: prednisolone + dipyridamole"
427904|NCT00551746|B3|Baseline|Total|Total of all reporting groups
427905|NCT00551746|B2|Baseline|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
427906|NCT00551746|B1|Baseline|Grape Juice|100% Grape Juice
427907|NCT00551746|P2|Participant Flow|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
427908|NCT00551746|P1|Participant Flow|Grape Juice|100% Grape Juice
427911|NCT00551746|E2|Reported Event|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
427912|NCT00551746|E1|Reported Event|Grape Juice|100% Grape Juice
427913|NCT00551759|B1|Baseline|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.
Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.
Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
427914|NCT00551759|P1|Participant Flow|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.
Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.
Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
427915|NCT00551759|O1|Outcome|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.
Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.
Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
427916|NCT00551759|E1|Reported Event|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|35 days of neoadjuvant chemoradiotherapy with oxaliplatin and infusional 5-fluorouracil plus cetuximab followed by post-operative docetaxel and cetuximab.
427917|NCT00553631|B3|Baseline|Total|Total of all reporting groups
427918|NCT00553631|B2|Baseline|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
427919|NCT00553631|B1|Baseline|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
427920|NCT00553631|P2|Participant Flow|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
427921|NCT00553631|P1|Participant Flow|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 unit per kilogram (U/kg) administered intravenously (IV) every other week for 39 weeks.
427922|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
427923|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
427924|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
427925|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
427926|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
427927|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
427928|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
427929|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
427930|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
427931|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
427932|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
427933|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
427934|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
427935|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
427936|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
427937|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
427938|NCT00553631|E2|Reported Event|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
427939|NCT00553631|E1|Reported Event|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
427953|NCT00553696|P3|Participant Flow|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
429086|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
427940|NCT00553644|B1|Baseline|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO"
427941|NCT00553644|P1|Participant Flow|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO"
427942|NCT00553644|O1|Outcome|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO"
427943|NCT00553644|O1|Outcome|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO"
427944|NCT00553644|O1|Outcome|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO"
427945|NCT00553644|O1|Outcome|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO"
427946|NCT00553644|E1|Reported Event|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|lenalidomide: Given PO
427947|NCT00553696|B5|Baseline|Total|Total of all reporting groups
427948|NCT00553696|B4|Baseline|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
427949|NCT00553696|B3|Baseline|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427950|NCT00553696|B2|Baseline|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427951|NCT00553696|B1|Baseline|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427952|NCT00553696|P4|Participant Flow|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
439648|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
427954|NCT00553696|P2|Participant Flow|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427955|NCT00553696|P1|Participant Flow|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427956|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
427957|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427958|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427959|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427960|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
427961|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427962|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427963|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427964|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
427965|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427966|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427967|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427968|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
427969|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427970|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427971|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427972|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
427973|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427974|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427975|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427976|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427977|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427978|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427979|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427980|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427981|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427982|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
427983|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
427984|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
427985|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427986|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (Dose Escalation Cohort)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily regimen for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427987|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427988|NCT00553696|E4|Reported Event|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
427989|NCT00553696|E3|Reported Event|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427990|NCT00553696|E2|Reported Event|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
427991|NCT00553696|E1|Reported Event|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
427992|NCT00553735|B1|Baseline|Arm I|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
427993|NCT00553735|P1|Participant Flow|All Study Participants|"Each eye of every participant was randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
427994|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Arificial Tear: Artificial Tear - three times a day for 18 months."
427995|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
428077|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
428078|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
428079|NCT00554099|E3|Reported Event|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
428080|NCT00554099|E2|Reported Event|Mesalamine|400 mg mesalamine (6 tablets daily)
427996|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Arificial Tear: Artificial Tear - three times a day for 18 months."
427997|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
427998|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Arificial Tear: Artificial Tear - three times a day for 18 months."
427999|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
428000|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Arificial Tear: Artificial Tear - three times a day for 18 months."
428001|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
428002|NCT00553735|O2|Outcome|Artificial Tear|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Artificial Tear three times a day for 18 months."
428003|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
428004|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Arificial Tear: Artificial Tear - three times a day for 18 months."
428005|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
428006|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Arificial Tear: Artificial Tear - three times a day for 18 months."
428007|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
428008|NCT00553735|E1|Reported Event|Arm I|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
428009|NCT00553787|B4|Baseline|Total|Total of all reporting groups
428010|NCT00553787|B3|Baseline|VI-0521 Top|15 mg/92 mg phentermine/topiramate
428011|NCT00553787|B2|Baseline|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
428012|NCT00553787|B1|Baseline|Placebo|
428013|NCT00553787|P3|Participant Flow|VI-0521 Top|15 mg/92 mg phentermine/topiramate
428014|NCT00553787|P2|Participant Flow|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
428015|NCT00553787|P1|Participant Flow|Placebo|
428016|NCT00553787|O3|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
428017|NCT00553787|O2|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
428018|NCT00553787|O1|Outcome|Placebo|
428019|NCT00553787|O3|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
428020|NCT00553787|O2|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
428021|NCT00553787|O1|Outcome|Placebo|
428022|NCT00553787|E3|Reported Event|VI-0521 Top|15 mg/92 mg phentermine/topiramate
428023|NCT00553787|E2|Reported Event|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
428024|NCT00553787|E1|Reported Event|Placebo|
428025|NCT00553839|B1|Baseline|Ketamine|"Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given.
ketamine hydrochloride: Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus."
428026|NCT00553839|P1|Participant Flow|Single Group Assignment|
428027|NCT00553839|O1|Outcome|Single Group Assignment|
428028|NCT00553839|O1|Outcome|Single Group Assignment|
428029|NCT00553839|O1|Outcome|Single Group Assignment|
428030|NCT00553839|E1|Reported Event|Single Group Assignment|
428031|NCT00553969|B5|Baseline|Total|Total of all reporting groups
428032|NCT00553969|B4|Baseline|4 Placebo + Placebo|
428033|NCT00553969|B3|Baseline|3 Lisinopril + Placebo|"lisinopril + placebo
lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
428034|NCT00553969|B2|Baseline|2 Coreg CR + Placebo|"Coreg CR + placebo
carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
428035|NCT00553969|B1|Baseline|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril
carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
428036|NCT00553969|P4|Participant Flow|4 Placebo + Placebo|
428037|NCT00553969|P3|Participant Flow|3 Lisinopril + Placebo|"lisinopril + placebo
lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
428038|NCT00553969|P2|Participant Flow|2 Coreg CR + Placebo|"Coreg CR + placebo
carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
428039|NCT00553969|P1|Participant Flow|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril
carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
428040|NCT00553969|O4|Outcome|4 Placebo + Placebo|
428041|NCT00553969|O3|Outcome|3 Lisinopril + Placebo|"lisinopril + placebo
lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
428042|NCT00553969|O2|Outcome|2 Coreg CR + Placebo|"Coreg CR + placebo
carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
428043|NCT00553969|O1|Outcome|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril
carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
428044|NCT00553969|E4|Reported Event|4 Placebo + Placebo|
428045|NCT00553969|E3|Reported Event|3 Lisinopril + Placebo|"lisinopril + placebo
lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
428046|NCT00553969|E2|Reported Event|2 Coreg CR + Placebo|"Coreg CR + placebo
carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
428047|NCT00553969|E1|Reported Event|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril
carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
428048|NCT00554099|B4|Baseline|Total|Total of all reporting groups
428049|NCT00554099|B3|Baseline|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
428050|NCT00554099|B2|Baseline|Mesalamine|400 mg mesalamine (6 tablets daily)
428051|NCT00554099|B1|Baseline|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
428052|NCT00554099|P3|Participant Flow|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
428053|NCT00554099|P2|Participant Flow|Mesalamine|400 mg mesalamine (6 tablets daily)
428054|NCT00554099|P1|Participant Flow|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
428055|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
428056|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
428057|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
428058|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
428059|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
428060|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
428061|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
428062|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
428063|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
428064|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
428065|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
428066|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
428067|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
428068|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
428069|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
428070|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
428071|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
428072|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
428073|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
428074|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
428075|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
428076|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
428083|NCT00554190|P1|Participant Flow|AdvaCoat and Merogel|AdvaCoat compared to Merogel Injectable. Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus tissues and Merogel applied to the middle meatus tissues on the opposite side.
428084|NCT00554190|O2|Outcome|AdvaCoat Sinus Gel|AdvaCoat compared to MeroGel Injectable
428085|NCT00554190|O1|Outcome|Merogel Injectable|Merogel Injectable compared to AdvaCoat
428086|NCT00554190|O2|Outcome|AdvaCoat Sinus Gel|AdvaCoat compared to MeroGel Injectable
428087|NCT00554190|O1|Outcome|Merogel Injectable|Merogel Injectable compared to AdvaCoat
428088|NCT00554216|B4|Baseline|Total|Total of all reporting groups
428089|NCT00554216|B3|Baseline|VI-0521 Top|PHEN/TPM 15/92
428090|NCT00554216|B2|Baseline|VI-0521 Low|PHEN/TPM 3.75/23
428091|NCT00554216|B1|Baseline|Placebo|
428092|NCT00554216|P3|Participant Flow|VI-0521 Top|PHEN/TPM 15 mg/92 mg
428093|NCT00554216|P2|Participant Flow|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
428094|NCT00554216|P1|Participant Flow|Placebo|
428095|NCT00554216|O3|Outcome|VI-0521 Top|PHEN/TPM 15 mg/92 mg
428096|NCT00554216|O2|Outcome|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
428097|NCT00554216|O1|Outcome|Placebo|
428098|NCT00554216|O3|Outcome|VI-0521 Top|PHEN/TPM 15 mg/92 mg
428099|NCT00554216|O2|Outcome|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
428100|NCT00554216|O1|Outcome|Placebo|
428101|NCT00554216|E3|Reported Event|VI-0521 Top|PHEN/TPM 15/92
428102|NCT00554216|E2|Reported Event|VI-0521 Low|PHEN/TPM 3.75/23
428103|NCT00554216|E1|Reported Event|Placebo|
428104|NCT00554229|B3|Baseline|Total|Total of all reporting groups
428105|NCT00554229|B2|Baseline|Placebo|Placebo oral tablet once daily
428106|NCT00554229|B1|Baseline|ZD4054|ZD4054 10 mg oral tablet once daily
428107|NCT00554229|P2|Participant Flow|Placebo|Placebo oral tablet once daily
428108|NCT00554229|P1|Participant Flow|ZD4054|ZD4054 10 mg oral tablet once daily
428109|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
428110|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
428111|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
428112|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
428113|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
428114|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
428115|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
428116|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
428117|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
428118|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
428119|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
428120|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
428121|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
428122|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
428123|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
428124|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
428125|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
428126|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
428127|NCT00554229|E2|Reported Event|Placebo|Placebo oral tablet once daily
428128|NCT00554229|E1|Reported Event|ZD4054|ZD4054 10 mg oral tablet once daily
428129|NCT00554294|B3|Baseline|Total|Total of all reporting groups
428130|NCT00554294|B2|Baseline|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
428131|NCT00554294|B1|Baseline|Control Group|Schools did not receive any intervention.
428132|NCT00554294|P2|Participant Flow|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
428133|NCT00554294|P1|Participant Flow|Control Group|Schools did not receive any intervention.
428134|NCT00554294|O2|Outcome|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
428135|NCT00554294|O1|Outcome|Control Group|Schools did not receive any intervention.
428136|NCT00554372|B3|Baseline|Total|Total of all reporting groups
428137|NCT00554372|B2|Baseline|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428138|NCT00554372|B1|Baseline|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428139|NCT00554372|P2|Participant Flow|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428140|NCT00554372|P1|Participant Flow|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428141|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428142|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428143|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428144|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428145|NCT00554372|O2|Outcome|High Dose|"1e9 pfu (plaque-forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart)
JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF): Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29."
428146|NCT00554372|O1|Outcome|Low Dose|"1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart)
JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF): Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29."
428147|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428148|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428149|NCT00554372|E2|Reported Event|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428150|NCT00554372|E1|Reported Event|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
428151|NCT00554463|B1|Baseline|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
428152|NCT00554463|P1|Participant Flow|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
428153|NCT00554463|O1|Outcome|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
428154|NCT00554463|E1|Reported Event|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
428155|NCT00554515|B1|Baseline|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
428156|NCT00554515|P1|Participant Flow|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
428157|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
428158|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
428159|NCT00554515|O2|Outcome|CA-9 SNP Variant|Patient’s SNP (Single Nucleotide Polymorphism) status is determined by sequencing their tumor specimens. Patients are classified as homozygous or variant based on the observed nucleotide sequence.
428160|NCT00554515|O1|Outcome|CA-9 SNP Homozygous|Patient’s SNP (Single Nucleotide Polymorphism) status is determined by sequencing their tumor specimens. Patients are classified as homozygous or variant based on the observed nucleotide sequence.
428161|NCT00554515|O2|Outcome|Positive|
428162|NCT00554515|O1|Outcome|Negative|
428163|NCT00554515|O2|Outcome|PD-L1 Tumor Positive|
428164|NCT00554515|O1|Outcome|PD-L1 Tumor Negative|
428165|NCT00554515|O2|Outcome|Low CA-9 Score|This score is based on the expression of the CA 9 protein (encoded by the CA9 gene) assessed from patient’s tumor specimen. CA 9 expression score is quantified by immunohistochemical analysis using CA9 monoclonal antibody (M75); Low is </=85% of CAIX positive tumor cells
428166|NCT00554515|O1|Outcome|High CA-9 Score|This score is based on the expression of the CA 9 protein (encoded by the CA9 gene) assessed from patient’s tumor specimen. CA 9 expression score is quantified by immunohistochemical analysis using CA9 monoclonal antibody (M75); High is >85% of CAIX positive tumor cells.
428167|NCT00554515|O3|Outcome|Poor Clear Cell Histology Risk Group|
428168|NCT00554515|O2|Outcome|Intermediate Clear Cell Histology Risk Group|
428169|NCT00554515|O1|Outcome|Good Clear Cell Histology Risk Group|
428170|NCT00554515|O2|Outcome|Non-clear Cell Tumor Type|
428172|NCT00554515|O3|Outcome|High UCLA SANI Score|This tool predicts RCC patient’s survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
428173|NCT00554515|O2|Outcome|Intermediate UCLA SANI Score|This tool predicts RCC patient’s survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
428174|NCT00554515|O1|Outcome|Low UCLA SANI Score|This tool predicts RCC patient’s survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
428175|NCT00554515|O3|Outcome|Poor MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
428176|NCT00554515|O2|Outcome|Intermediate MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
428177|NCT00554515|O1|Outcome|Favorable MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
428178|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
428179|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
428180|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
428181|NCT00554515|O1|Outcome|ISM Poor Risk Group|"ISM [Atkins et al CCR 2005]:
Poor predictive pathology OR the combination of intermediate predictive pathology and low CAIX staining
Pathology [Upton et al. J Immunother 2005] Poor predictive pathology: non-clear-cell histology OR some (>0%) papillary features OR no alveolar features OR >50% granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (>0%) alveolar features AND 50% granular features
CAIX [Bui et al. CCR 2003] Low CAIX staining: </=85% of CAIX positive tumor cells"
428182|NCT00554515|O1|Outcome|ISM Good Risk Group|"ISM [Atkins et al CCR 2005]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology [Upton et al. J Immunother 2005] Good predictive pathology: clear-cell histology AND no papillary features AND >50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (>0%) alveolar features AND 50% granular features
CAIX [Bui et al. CCR 2003] High CAIX staining: >85% of CAIX positive tumor cells"
428183|NCT00554515|E1|Reported Event|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
428184|NCT00554619|B1|Baseline|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
428185|NCT00554619|P1|Participant Flow|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
428186|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
428187|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
428188|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
428189|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
428190|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
428191|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
428192|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
428193|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
428194|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
439649|NCT00577135|O4|Outcome|High Intensification|
428195|NCT00554619|E1|Reported Event|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
428196|NCT00554671|B3|Baseline|Total|Total of all reporting groups
428197|NCT00554671|B2|Baseline|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
428198|NCT00554671|B1|Baseline|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification
Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes
Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals
Group support: Peer support are provided in the group setting
Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
428199|NCT00554671|P2|Participant Flow|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
428200|NCT00554671|P1|Participant Flow|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification
Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes
Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals
Group support: Peer support are provided in the group setting
Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
428201|NCT00554671|O2|Outcome|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
428202|NCT00554671|O1|Outcome|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification
Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes
Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals
Group support: Peer support are provided in the group setting
Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
428203|NCT00554671|O2|Outcome|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
428204|NCT00554671|O1|Outcome|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification
Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes
Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals
Group support: Peer support are provided in the group setting
Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
428205|NCT00554671|E2|Reported Event|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
428206|NCT00554671|E1|Reported Event|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification
Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes
Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals
Group support: Peer support are provided in the group setting
Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
428207|NCT00554749|B1|Baseline|Behavioral|All participants received identical behavioral treatment with no control group.
428208|NCT00554749|P1|Participant Flow|Behavioral|All participants received identical behavioral treatment with no control group.
428209|NCT00554749|O1|Outcome|Behavioral|All participants received identical behavioral treatment with no control group.
428210|NCT00554749|O1|Outcome|Behavioral|All participants received identical behavioral treatment with no control group.
428211|NCT00554749|E1|Reported Event|Behavioral|All participants received identical behavioral treatment with no control group.
428212|NCT00554801|B3|Baseline|Total|Total of all reporting groups
428213|NCT00554801|B2|Baseline|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
428214|NCT00554801|B1|Baseline|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.
Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
428215|NCT00554801|P2|Participant Flow|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
428216|NCT00554801|P1|Participant Flow|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.
Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
428217|NCT00554801|O2|Outcome|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
428218|NCT00554801|O1|Outcome|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.
Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
428219|NCT00554801|E2|Reported Event|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
428220|NCT00554801|E1|Reported Event|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.
Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
428221|NCT00554840|B3|Baseline|Total|Total of all reporting groups
428222|NCT00554840|B2|Baseline|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
428223|NCT00554840|B1|Baseline|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
428224|NCT00554840|P2|Participant Flow|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
428225|NCT00554840|P1|Participant Flow|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
428226|NCT00554840|O2|Outcome|Placebo|Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
428227|NCT00554840|O1|Outcome|Varenicline|Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
428228|NCT00554840|O2|Outcome|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
428229|NCT00554840|O1|Outcome|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
428230|NCT00554840|O2|Outcome|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
428231|NCT00554840|O1|Outcome|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
428232|NCT00554840|O2|Outcome|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
428233|NCT00554840|O1|Outcome|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
428234|NCT00554840|O2|Outcome|Placebo|Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
428235|NCT00554840|O1|Outcome|Varenicline|Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
428236|NCT00554840|O2|Outcome|Placebo|Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
428237|NCT00554840|O1|Outcome|Varenicline|Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
428238|NCT00554840|E2|Reported Event|Placebo|Subjects randomized to matching placebo will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
428239|NCT00554840|E1|Reported Event|Varenicline|Subjects randomized to receive active drug (varenicline) will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
428240|NCT00554853|B3|Baseline|Total|Total of all reporting groups
428241|NCT00554853|B2|Baseline|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to pioglitazone for 3 months, crossover after a 2 month washout.
428242|NCT00554853|B1|Baseline|Study Drug (Pioglitazone) Then Placebo|Oral daily pioglitazone for 3 months compared to placebo for 3 months,crossover after a 2 month washout.
428243|NCT00554853|P2|Participant Flow|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) for 3 months.
428244|NCT00554853|P1|Participant Flow|Study Drug (Pioglitazone) Then Placebo|Oral daily pioglitazone (study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
428245|NCT00554853|O2|Outcome|All Participants While on Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
428246|NCT00554853|O1|Outcome|All Participants While on Placebo|Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
428247|NCT00554853|O2|Outcome|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
428248|NCT00554853|O1|Outcome|Study Drug (Pioglitazone) Then Placebo|Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
428249|NCT00554853|E6|Reported Event|Placebo Then Study Drug (Piolglitazone) While on Study Drug|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
428250|NCT00554853|E5|Reported Event|Placebo Then Study Drug (Pioglitazone) During Washout|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
428251|NCT00554853|E4|Reported Event|Placebo Then Study Drug (Pioglitazone) While on Placebo|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
428252|NCT00554853|E3|Reported Event|Study Drug (Pioglitazone) Then Placebo, While on Placebo|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
428253|NCT00554853|E2|Reported Event|Study Drug (Pioglitazone) Then Placebo, During Washout|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
428254|NCT00554853|E1|Reported Event|Study Drug (Pioglitazone) Then Placebo, While on Drug|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
428255|NCT00554970|B5|Baseline|Total|Total of all reporting groups
428256|NCT00554970|B4|Baseline|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
428257|NCT00554970|B3|Baseline|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
428258|NCT00554970|B2|Baseline|Treatment 2, Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
428259|NCT00554970|B1|Baseline|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
428260|NCT00554970|P4|Participant Flow|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
428261|NCT00554970|P3|Participant Flow|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
428262|NCT00554970|P2|Participant Flow|Treatment 2 Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
428263|NCT00554970|P1|Participant Flow|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
428264|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
428265|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
428266|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
428267|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
428268|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
428269|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
428270|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
428271|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
428272|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
428273|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
428274|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
428275|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
428276|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
428277|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
428278|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
428279|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
428280|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
428281|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
428282|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
428283|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
428284|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
428285|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
428286|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
428287|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
428288|NCT00554970|E4|Reported Event|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
428289|NCT00554970|E3|Reported Event|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
428290|NCT00554970|E2|Reported Event|Treatment 2, Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
428291|NCT00554970|E1|Reported Event|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
428292|NCT00554996|B1|Baseline|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
428293|NCT00554996|P1|Participant Flow|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
428294|NCT00554996|O1|Outcome|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
428295|NCT00554996|E1|Reported Event|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
428296|NCT00555009|B3|Baseline|Total|Total of all reporting groups
428297|NCT00555009|B2|Baseline|Placebo|Matching placebo injected SC.
428298|NCT00555009|B1|Baseline|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428299|NCT00555009|P2|Participant Flow|Placebo|Matching placebo injected SC.
428300|NCT00555009|P1|Participant Flow|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428301|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
428302|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428303|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
428304|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428305|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
428306|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428307|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
428308|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428309|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
428310|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428311|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
428312|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428313|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
428314|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428315|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
428316|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428317|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
428318|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428319|NCT00555009|E2|Reported Event|Placebo|Matching placebo injected SC.
428320|NCT00555009|E1|Reported Event|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
428321|NCT00555048|B1|Baseline|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
alemtuzumab
busulfan
cyclophosphamide
methotrexate
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
428322|NCT00555048|P1|Participant Flow|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
alemtuzumab
busulfan
cyclophosphamide
methotrexate
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
428323|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
alemtuzumab
busulfan
cyclophosphamide
methotrexate
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
428324|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
alemtuzumab
busulfan
cyclophosphamide
methotrexate
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
428325|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
alemtuzumab
busulfan
cyclophosphamide
methotrexate
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
428326|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
alemtuzumab
busulfan
cyclophosphamide
methotrexate
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
428327|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
alemtuzumab
busulfan
cyclophosphamide
methotrexate
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
428328|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
alemtuzumab
busulfan
cyclophosphamide
methotrexate
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
428329|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
alemtuzumab
busulfan
cyclophosphamide
methotrexate
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
428330|NCT00555048|E1|Reported Event|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
alemtuzumab
busulfan
cyclophosphamide
methotrexate
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
428331|NCT00555061|B1|Baseline|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
428332|NCT00555061|P1|Participant Flow|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
428333|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
428334|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
428335|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
428336|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
428337|NCT00555061|E1|Reported Event|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
428338|NCT00555152|B5|Baseline|Total|Total of all reporting groups
428339|NCT00555152|B4|Baseline|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
428340|NCT00555152|B3|Baseline|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
428341|NCT00555152|B2|Baseline|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
428342|NCT00555152|B1|Baseline|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
428343|NCT00555152|P4|Participant Flow|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
439650|NCT00577135|O3|Outcome|Low Intensification|
428344|NCT00555152|P3|Participant Flow|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
428345|NCT00555152|P2|Participant Flow|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
428346|NCT00555152|P1|Participant Flow|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
428347|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
428348|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
428349|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
428350|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
428351|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
428352|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
428353|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
428354|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
428355|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
428356|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
428357|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
428358|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
428359|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
428360|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
428361|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
428362|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
428363|NCT00555152|E4|Reported Event|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
428364|NCT00555152|E3|Reported Event|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
428365|NCT00555152|E2|Reported Event|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
428366|NCT00555152|E1|Reported Event|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
428367|NCT00555217|B3|Baseline|Total|Total of all reporting groups
428368|NCT00555217|B2|Baseline|Monotherapy ARB|"Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
losartan: 50 or 100mg/day"
428369|NCT00555217|B1|Baseline|Combination of ARB and ACEI|"Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
losartan: 50 or 100mg/day
lisinopril: 10, 20 or 40 mg/day"
428370|NCT00555217|P2|Participant Flow|Monotherapy ARB|"Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
losartan: 50 or 100mg/day"
428371|NCT00555217|P1|Participant Flow|Combination of ARB and ACEI|"Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
losartan: 50 or 100mg/day
lisinopril: 10, 20 or 40 mg/day"
428372|NCT00555217|O2|Outcome|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
428373|NCT00555217|O1|Outcome|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
428374|NCT00555217|O2|Outcome|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
428375|NCT00555217|O1|Outcome|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
428376|NCT00555217|E2|Reported Event|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
428377|NCT00555217|E1|Reported Event|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
428378|NCT00555321|B6|Baseline|Total|Total of all reporting groups
428379|NCT00555321|B5|Baseline|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428380|NCT00555321|B4|Baseline|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428381|NCT00555321|B3|Baseline|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428382|NCT00555321|B2|Baseline|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428383|NCT00555321|B1|Baseline|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428384|NCT00555321|P5|Participant Flow|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428755|NCT00555568|P2|Participant Flow|Arm 2: Clinician Led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
428385|NCT00555321|P4|Participant Flow|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428386|NCT00555321|P3|Participant Flow|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428387|NCT00555321|P2|Participant Flow|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428388|NCT00555321|P1|Participant Flow|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428389|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428390|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428391|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428392|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428393|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428394|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428395|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428396|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428397|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428398|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428399|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428400|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428401|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428402|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428403|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428404|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428405|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428406|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428407|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428408|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428409|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428410|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428411|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428412|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428413|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428414|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428415|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428416|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428417|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428418|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428419|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428420|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428421|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428422|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428423|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428424|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428425|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428426|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428427|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428449|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428428|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428429|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428430|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428431|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428432|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428433|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428434|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428435|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428436|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428437|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428438|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428439|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428440|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428441|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428442|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428443|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428444|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428445|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428446|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428447|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428448|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428450|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428451|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428452|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428453|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428454|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428455|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428456|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428457|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428458|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428459|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428460|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428461|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428462|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428463|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428464|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428465|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428466|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428467|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428468|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428469|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428470|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428756|NCT00555568|P1|Participant Flow|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
428471|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428472|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428473|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428474|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428475|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428476|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428477|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428478|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428479|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428480|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428481|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428482|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428483|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428484|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428485|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428486|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428487|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428488|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428489|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428490|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428757|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
439651|NCT00577135|O2|Outcome|Continuous Infusion|
428491|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428492|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428493|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428494|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428495|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428496|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428497|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428498|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428499|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428500|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428501|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428502|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428503|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428504|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428505|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428506|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428507|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428508|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428509|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428510|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428758|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
428511|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428512|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428513|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428514|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428515|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428516|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428517|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428518|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428519|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428520|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428521|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428522|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428523|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428524|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428525|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428526|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428527|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428528|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428529|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428530|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428759|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
428531|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428532|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428533|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428534|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428535|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428536|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428537|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428538|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428539|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
428540|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428541|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428542|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
428543|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
428544|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428545|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428546|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428547|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428548|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428549|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428550|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428551|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428552|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428553|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428554|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428555|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428556|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428557|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428558|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428559|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428560|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428561|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428562|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428563|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428564|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428565|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428566|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428567|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428568|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428569|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428570|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428571|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428572|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428595|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428573|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428574|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428575|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428576|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428577|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428578|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428579|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428580|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428581|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428582|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428583|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428584|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428585|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428586|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428587|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428588|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428589|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428590|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428591|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428592|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428593|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428594|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428596|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428597|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428598|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428599|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428600|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428601|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428602|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428603|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428604|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428605|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428606|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428607|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428608|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428609|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428610|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428611|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428612|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428613|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428614|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428615|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428616|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428660|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428617|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428618|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428619|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428620|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428621|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428622|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428623|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428624|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428625|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428626|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428627|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428628|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428629|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428630|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428631|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428632|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428633|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428634|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428635|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428636|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428637|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428760|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
428761|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
428638|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428639|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428640|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428641|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428642|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428643|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428644|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428645|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428646|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428647|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428648|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428649|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428650|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428651|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428652|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428653|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428654|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428655|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428656|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428657|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428658|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428659|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428661|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428662|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428663|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428664|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428665|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428666|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428667|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428668|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428669|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428670|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428671|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428672|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428673|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428674|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428675|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428676|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428677|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428678|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428679|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
428680|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428681|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
428762|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
428763|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
428682|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428683|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
428684|NCT00555321|E5|Reported Event|Tacrolimus + MMF|
428685|NCT00555321|E4|Reported Event|Tacrolimus|
428686|NCT00555321|E3|Reported Event|Belaticept (LI) + MMF|
428687|NCT00555321|E2|Reported Event|MI+MMF|
428688|NCT00555321|E1|Reported Event|Basiliximab+Belatacept (MI)+Mycophenolate Mofetil (MMF)|
428689|NCT00555360|B3|Baseline|Total|Total of all reporting groups
428690|NCT00555360|B2|Baseline|mHealth Plus CarePartner|Wkly IVR calls for 12 months+feedback to CarePartner
428691|NCT00555360|B1|Baseline|Standard mHealth|Weekly IVR calls for 12 months
428692|NCT00555360|P2|Participant Flow|mHealth Plus CarePartner|Wkly IVR calls for 12 months+feedback to CarePartner
428693|NCT00555360|P1|Participant Flow|Standard mHealth|Weekly IVR calls for 12 months
428694|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
428695|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
428696|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
428697|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
428698|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+CarePartner feedback
428699|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
428700|NCT00555360|E2|Reported Event|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
428701|NCT00555360|E1|Reported Event|Standard mHealth|Weekly IVR calls for 12 months
428702|NCT00555425|B3|Baseline|Total|Total of all reporting groups
428703|NCT00555425|B2|Baseline|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.
Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
428704|NCT00555425|B1|Baseline|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.
Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
428705|NCT00555425|P2|Participant Flow|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.
Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
428706|NCT00555425|P1|Participant Flow|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.
Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
428707|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.
Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
428708|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.
Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
428947|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428709|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.
Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
428710|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.
Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
428711|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.
Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
428712|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.
Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
428713|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.
Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
428714|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.
Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
428715|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.
Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
428716|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.
Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
428717|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.
Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
428735|NCT00555464|P1|Participant Flow|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.
Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
428718|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.
Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
428719|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.
Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
428720|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.
Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
428721|NCT00555425|E2|Reported Event|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.
Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
428722|NCT00555425|E1|Reported Event|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.
Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
428723|NCT00555438|B1|Baseline|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
428724|NCT00555438|P1|Participant Flow|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
428725|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
428726|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
428727|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
428728|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
428729|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
428730|NCT00555438|E1|Reported Event|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
428731|NCT00555464|B3|Baseline|Total|Total of all reporting groups
428732|NCT00555464|B2|Baseline|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.
Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
428733|NCT00555464|B1|Baseline|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.
Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
428734|NCT00555464|P2|Participant Flow|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.
Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
428753|NCT00555568|B1|Baseline|Arm 1: Peer-Led Group|"Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
recovery oriented mental health peer support group: This is a recovery-focused mental health education and support group led by peer facilitators"
428754|NCT00555568|P3|Participant Flow|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
428736|NCT00555464|O2|Outcome|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.
Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
428737|NCT00555464|O1|Outcome|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.
Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
428738|NCT00555464|O2|Outcome|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.
Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
428739|NCT00555464|O1|Outcome|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.
Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
428740|NCT00555464|E2|Reported Event|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.
Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
428741|NCT00555464|E1|Reported Event|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.
Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
428742|NCT00555477|B3|Baseline|Total|Total of all reporting groups
428743|NCT00555477|B2|Baseline|Anastrozole Part 2|Analysis of the first 18 subjects enrolled revealed a greater than expected discontinuation of AI therapy because of elevated serum estradiol concentrations. Discontinuation was believed to be primarily due to greater than expected variability in the assay as opposed to true recovery of ovarian function. Therefore, the protocol was amended. Subjects with an average baseline estradiol concentration of ≤20 pg/ml were considered eligible for part 2 and initiated treatment with anastrozole 1 mg orally daily.
428744|NCT00555477|B1|Baseline|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
428745|NCT00555477|P2|Participant Flow|Anastrozole Part 2|During the conduct of the trial the study was amended to change the eligibility criteria because of difficulties with the estradiol assay. Subjects enrolled after the amendment were required to sign consent and then have an average baseline estradiol concentration of ≤20 pg/ml in order to be considered eligible.
428746|NCT00555477|P1|Participant Flow|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH (Follicle-stimulating hormone) concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
428747|NCT00555477|O2|Outcome|Anastrozole Part 2|Analysis of the first 18 subjects enrolled revealed a greater than expected discontinuation of AI therapy because of elevated serum estradiol concentrations. Discontinuation was believed to be primarily due to greater than expected variability in the assay as opposed to true recovery of ovarian function. Therefore, the protocol was amended. Subjects with an average baseline estradiol concentration of ≤20 pg/ml were considered eligible for part 2 and initiated treatment with anastrozole 1 mg orally daily.
428748|NCT00555477|O1|Outcome|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
428749|NCT00555477|E1|Reported Event|Anastrozole|anastrozole: 1 mg tablet by mouth once a day
428750|NCT00555568|B4|Baseline|Total|Total of all reporting groups
428751|NCT00555568|B3|Baseline|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
428752|NCT00555568|B2|Baseline|Arm 2: Clinician-Led Group|"Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
recovery-oriented mental health clinician-led group: This is a recovery-focused mental health education and support group led by a mental health clinician"
428948|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428764|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
428765|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
428766|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
428767|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
428768|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
428769|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
428770|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
428771|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
428772|NCT00555568|E3|Reported Event|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
428773|NCT00555568|E2|Reported Event|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
428774|NCT00555568|E1|Reported Event|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
428775|NCT00555620|B7|Baseline|Total|Total of all reporting groups
428776|NCT00555620|B6|Baseline|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428777|NCT00555620|B5|Baseline|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428778|NCT00555620|B4|Baseline|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428779|NCT00555620|B3|Baseline|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428780|NCT00555620|B2|Baseline|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428781|NCT00555620|B1|Baseline|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
428782|NCT00555620|P6|Participant Flow|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428783|NCT00555620|P5|Participant Flow|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428784|NCT00555620|P4|Participant Flow|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428785|NCT00555620|P3|Participant Flow|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428786|NCT00555620|P2|Participant Flow|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428787|NCT00555620|P1|Participant Flow|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
428788|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428789|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428790|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428791|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428792|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428793|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
428794|NCT00555620|O5|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428795|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428796|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428797|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428798|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
428799|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428800|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428801|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428802|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428803|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428804|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
428805|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428806|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428807|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428808|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428809|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428810|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428811|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428812|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428813|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428814|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428815|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428816|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428817|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428818|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428819|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428820|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428821|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428822|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428823|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428824|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428825|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428949|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428826|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428827|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428828|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428829|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428830|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428831|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428832|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428833|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428834|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428835|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428836|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428837|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428838|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428839|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428840|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428841|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428842|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428843|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428844|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428845|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428846|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428847|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428848|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428849|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428850|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428851|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428852|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428853|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428854|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428855|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428950|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428856|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428857|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428858|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428859|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428860|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428861|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428862|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428863|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428864|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428865|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428866|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428867|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428868|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428869|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428870|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428871|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428872|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428873|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428874|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428875|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428876|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428877|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428878|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428879|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428880|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428881|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428882|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428883|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428884|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428885|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428951|NCT00555750|E2|Reported Event|Placebo|nightly administration of placebo before bed
428886|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428887|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428888|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428889|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428890|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428891|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
428892|NCT00555620|E6|Reported Event|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428893|NCT00555620|E5|Reported Event|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428894|NCT00555620|E4|Reported Event|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428895|NCT00555620|E3|Reported Event|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428896|NCT00555620|E2|Reported Event|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
428897|NCT00555620|E1|Reported Event|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
428898|NCT00555672|B3|Baseline|Total|Total of all reporting groups
428899|NCT00555672|B2|Baseline|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428900|NCT00555672|B1|Baseline|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428901|NCT00555672|P2|Participant Flow|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428902|NCT00555672|P1|Participant Flow|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428903|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428904|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428905|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428906|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428907|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428908|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428909|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428910|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428911|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428912|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428913|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428914|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428915|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428916|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428917|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428918|NCT00555672|E2|Reported Event|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428919|NCT00555672|E1|Reported Event|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
428920|NCT00555750|B3|Baseline|Total|Total of all reporting groups
428921|NCT00555750|B2|Baseline|Placebo|nightly administration of placebo before bed
428922|NCT00555750|B1|Baseline|Active|active medication administration nightly before bed
428923|NCT00555750|P2|Participant Flow|Placebo|nightly placebo (identical tablet to active medication) oral administration ~30 min before bed
428924|NCT00555750|P1|Participant Flow|Eszopiclone|nightly active medication (eszopiclone, 3 mg tablet) oral administration ~30 min before bed
428925|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428926|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428927|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428928|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428929|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428930|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428931|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428932|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428933|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428934|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428935|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428936|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428937|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428938|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428939|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428940|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428941|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428942|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428943|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428944|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428945|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
428946|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
428954|NCT00555880|B2|Baseline|Placebo/Midodrine|Participants received matching Placebo followed by a single oral dose of Midodrine HCl the next day
428955|NCT00555880|B1|Baseline|Midodrine/Placebo|Participants received a single oral dose of Midodrine HCl followed by matching Placebo the next day
428956|NCT00555880|P2|Participant Flow|Placebo/Midodrine|Participants received Placebo followed by a single oral dose of Midodrine HCl the next day
428957|NCT00555880|P1|Participant Flow|Midodrine/Placebo|Participants received a single oral dose of Midodrine hydrochloride (HCl) followed by matching Placebo the next day
428958|NCT00555880|O1|Outcome|All Participants|All randomized participants
428959|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428960|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428961|NCT00555880|O1|Outcome|All Participants|All randomized participants
428962|NCT00555880|O1|Outcome|All Participants|All randomized participants
428963|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428964|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428965|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428966|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428967|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428968|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428969|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428970|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428971|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428972|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428973|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428974|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428975|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428976|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428977|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428978|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428979|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428980|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428981|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428982|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428983|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428984|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428985|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428986|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428987|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428988|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428989|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
428990|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
428991|NCT00555880|E2|Reported Event|Placebo/Midodrine|Participants received Placebo followed by a single oral dose of Midodrine HCl (10-30mg) the next day.
428992|NCT00555880|E1|Reported Event|Midodrine/Placebo|Participants received a single oral dose of Midodrine HCl (10-30mg) followed by placebo the next day.
428993|NCT00555893|B3|Baseline|Total|Total of all reporting groups
428994|NCT00555893|B2|Baseline|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.
Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
428995|NCT00555893|B1|Baseline|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:
for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
428996|NCT00555893|P2|Participant Flow|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.
Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
429056|NCT00555997|O1|Outcome|Ziprasidone Phase I|Results from phase I for those taking ziprasidone during that phase
429057|NCT00555997|O4|Outcome|Placebo Phase II|Results from phase II for those taking placebo during that phase
428997|NCT00555893|P1|Participant Flow|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:
for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
428998|NCT00555893|O2|Outcome|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.
Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
428999|NCT00555893|O1|Outcome|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:
for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
429000|NCT00555893|O2|Outcome|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.
Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
429001|NCT00555893|O1|Outcome|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:
for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
429002|NCT00555893|E2|Reported Event|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.
Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
429003|NCT00555893|E1|Reported Event|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:
for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
429004|NCT00555906|B4|Baseline|Total|Total of all reporting groups
429005|NCT00555906|B3|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase2:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429006|NCT00555906|B2|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule B)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429058|NCT00555997|O3|Outcome|Ziprasidone Phase II|Results from phase II for those taking ziprasidone during that phase
429059|NCT00555997|O2|Outcome|Placebo Phase I|Results from phase I for those taking placebo during that phase
429060|NCT00555997|O1|Outcome|Ziprasidone Phase I|Results from phase I for those taking ziprasidone during that phase
429061|NCT00555997|E2|Reported Event|Placebo|Adverse events experienced when taking placebo
429007|NCT00555906|B1|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429008|NCT00555906|P5|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429009|NCT00555906|P4|Participant Flow|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429010|NCT00555906|P3|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429011|NCT00555906|P2|Participant Flow|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429012|NCT00555906|P1|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 milligram (mg) capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 milligram per square meter (mg/m^2) intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429013|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429062|NCT00555997|E1|Reported Event|Ziprasidone|Adverse events experienced by subjects while taking ziprasidone
429063|NCT00556049|B1|Baseline|Treatment|"Sunitinib and gemcitabine
Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.
Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
429064|NCT00556049|P1|Participant Flow|Treatment|"Sunitinib and gemcitabine
Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.
Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
429087|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
429014|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429015|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429016|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429017|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429018|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429019|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429020|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429065|NCT00556049|O1|Outcome|Treatment|"Sunitinib and gemcitabine
Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.
Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
429066|NCT00556049|E1|Reported Event|Neutropenia|"Sunitinib and gemcitabine
Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.
Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
429067|NCT00556075|B4|Baseline|Total|Total of all reporting groups
429068|NCT00556075|B3|Baseline|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
429069|NCT00556075|B2|Baseline|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
429070|NCT00556075|B1|Baseline|Placebo|Placebo: 1 capsule daily for 4 months
429021|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429022|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429023|NCT00555906|O4|Outcome|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429024|NCT00555906|O3|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429025|NCT00555906|O2|Outcome|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429026|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429027|NCT00555906|O4|Outcome|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429071|NCT00556075|P3|Participant Flow|B 50 mg|Proellex 50 mg: 2 capsules daily for 4 months
429072|NCT00556075|P2|Participant Flow|A 25 mg|Proellex 25 mg: 1 capsule daily for 4 months
429073|NCT00556075|P1|Participant Flow|C Placebo|Placebo: 1 capsule daily for 4 months
429074|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
429075|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
429076|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
429077|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
429078|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
429028|NCT00555906|O3|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429029|NCT00555906|O2|Outcome|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429030|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429031|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429032|NCT00555906|O2|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429033|NCT00555906|O1|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429034|NCT00555906|O2|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429079|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
429080|NCT00556075|O3|Outcome|50 mg|"Proellex 50 mg
Proellex 50 mg: 2 capsules daily for 4 months"
429081|NCT00556075|O2|Outcome|25 mg|"Proellex 25 mg
Proellex 25 mg: 1 capsule daily for 4 months"
429082|NCT00556075|O1|Outcome|Placebo|"Placebo
Placebo: 1 capsule daily for 4 months"
429083|NCT00556075|O3|Outcome|50 mg|"Proellex 50 mg
Proellex 50 mg: 2 capsules daily for 4 months"
429084|NCT00556075|O2|Outcome|25 mg|"Proellex 25 mg
Proellex 25 mg: 1 capsule daily for 4 months"
429035|NCT00555906|O1|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429036|NCT00555906|E5|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429037|NCT00555906|E4|Reported Event|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429038|NCT00555906|E3|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429039|NCT00555906|E2|Reported Event|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429040|NCT00555906|E1|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
429041|NCT00555997|B4|Baseline|Total|Total of all reporting groups
429042|NCT00555997|B3|Baseline|Ziprasidone|Subjects received ziprasidone throughout study
429043|NCT00555997|B2|Baseline|Placebo|Subjects received placebo throughout study
429044|NCT00555997|B1|Baseline|Placebo/Ziprasidone|Received placebo in first phase and ziprasidone in second phase
429045|NCT00555997|P4|Participant Flow|Phase 2 Placebo|Patients who received placebo in phase 2.
429046|NCT00555997|P3|Participant Flow|Phase 2 Ziprasidone|Subjects taking ziprasidone in the second phase.
429047|NCT00555997|P2|Participant Flow|Phase 1 Placebo|Subjects taking placebo in the first phase.
429048|NCT00555997|P1|Participant Flow|Phase 1 Ziprasidone|Subjects taking ziprasidone in the first phase.
429049|NCT00555997|O4|Outcome|Phase 2 Placebo|Patients who received placebo in phase 2.
429050|NCT00555997|O3|Outcome|Phase 2 Ziprasidone|Subjects taking ziprasidone in the second phase.
429051|NCT00555997|O2|Outcome|Phase 1 Placebo|Subjects taking placebo in the first phase.
429052|NCT00555997|O1|Outcome|Phase 1 Ziprasidone|Subjects taking ziprasidone in the first phase.
429053|NCT00555997|O4|Outcome|Placebo Phase II|Results from phase II for those taking placebo during that phase
429054|NCT00555997|O3|Outcome|Ziprasidone Phase II|Results from phase II for those taking ziprasidone during that phase
429055|NCT00555997|O2|Outcome|Placebo Phase I|Results from phase I for those taking placebo during that phase
429088|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
429089|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
429090|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
429091|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
429092|NCT00556075|E3|Reported Event|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
429093|NCT00556075|E2|Reported Event|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
429094|NCT00556075|E1|Reported Event|Placebo|Placebo: 1 capsule daily for 4 months
429095|NCT00556140|B1|Baseline|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
429096|NCT00556140|P1|Participant Flow|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
429097|NCT00556140|O1|Outcome|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
429098|NCT00556140|O1|Outcome|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
429099|NCT00556140|E1|Reported Event|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
429100|NCT00549055|B1|Baseline|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
429101|NCT00549055|P1|Participant Flow|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
429102|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
429103|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
429104|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
429105|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
429106|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
429107|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
429108|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
429109|NCT00549055|E1|Reported Event|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
429110|NCT00556166|B1|Baseline|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
429111|NCT00556166|P1|Participant Flow|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
429112|NCT00556166|O1|Outcome|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
429113|NCT00556166|O1|Outcome|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
429114|NCT00556166|E1|Reported Event|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
429115|NCT00556322|B3|Baseline|Total|Total of all reporting groups
429116|NCT00556322|B2|Baseline|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429117|NCT00556322|B1|Baseline|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429118|NCT00556322|P2|Participant Flow|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429119|NCT00556322|P1|Participant Flow|Comparator|Participants received either pemetrexed 500 milligrams per square meter (mg/m^2) every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429377|NCT00559962|P4|Participant Flow|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
429120|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429121|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429122|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429123|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429124|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429125|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429126|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429127|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429128|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429129|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429130|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429131|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429132|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429133|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429134|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429135|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429136|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429174|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429378|NCT00559962|P3|Participant Flow|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
429137|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429138|NCT00556322|O2|Outcome|Erlotinib|Participants received a single oral dose of erlotinib 150 mg/day as a tablet until disease progression, unacceptable toxicity or death.
429139|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429140|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429141|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable t oxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429142|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429143|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429144|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429145|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429146|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429147|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429148|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429149|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429150|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429151|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429152|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429175|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429176|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429379|NCT00559962|P2|Participant Flow|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
429153|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel l75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429154|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429155|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429156|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429157|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429158|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429159|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429160|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429161|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429162|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
429163|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429164|NCT00556322|E2|Reported Event|Erlotinib|Participants received a single oral dose of erlotinib 150 mg/day until disease progression, unacceptable toxicity or death.
429165|NCT00556322|E1|Reported Event|Comparator|Participants received either Alimta 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or Taxotere 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, Taxotere was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
429166|NCT00556374|B3|Baseline|Total|Total of all reporting groups
429167|NCT00556374|B2|Baseline|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429168|NCT00556374|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429169|NCT00556374|P2|Participant Flow|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429170|NCT00556374|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy (AIT).
429171|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429172|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429173|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429177|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429178|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429179|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429180|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429181|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429182|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429183|NCT00556374|E2|Reported Event|Denosumab 60mg Q6M|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy
429184|NCT00556374|E1|Reported Event|Placebo Q6M|Participants received placebo subcutaneous injection once every 6 months (Q6M). All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
429185|NCT00556400|B3|Baseline|Total|Total of all reporting groups
429186|NCT00556400|B2|Baseline|Sugar Pill|
429187|NCT00556400|B1|Baseline|Lo-ovral|1 tablet of lo-ovral is administered twice a day
429188|NCT00556400|P2|Participant Flow|Sugar Pill|
429189|NCT00556400|P1|Participant Flow|Lo-ovral|1 tablet of lo-ovral is administered twice a day
429190|NCT00556400|O2|Outcome|Sugar Pill|
429191|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
429192|NCT00556400|O2|Outcome|Sugar Pill|
429193|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
429194|NCT00556400|O2|Outcome|Sugar Pill|
429195|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
429196|NCT00556400|E1|Reported Event|Sugar Pill|
429197|NCT00556426|B1|Baseline|Participants Receiving a Filter|Patients who were at temporary, increased risk of pulmonary embolism requiring inferior vena cava (IVC) interruption, and for whom Recovery G2 Filter retrieval could reasonably be expected to occur within 6 months of device placement.
429198|NCT00556426|P1|Participant Flow|All Patients Receiving the Filter|All enrolled subjects
429199|NCT00556426|O1|Outcome|Fractured Filters|retrieval of the filter such that the entire filter is retrieved
429200|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
429201|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
429202|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
429203|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
429204|NCT00556426|E1|Reported Event|All Patients Receiving the Filter|All enrolled subjects
429205|NCT00556452|B4|Baseline|Total|Total of all reporting groups
429206|NCT00556452|B3|Baseline|Clo/BU4 40mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 40 mg/m^2/day x 5 days
Busulfan IV 3.2 mg/kg daily x 4 days
Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
429207|NCT00556452|B2|Baseline|Clo/BU4 30mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 30 mg/m^2/day x 5 days
Busulfan IV 3.2 mg/kg daily x 4 days
Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
429208|NCT00556452|B1|Baseline|Clo/BU4 20mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 20 mg/m^2/day x 5 days
Busulfan IV 3.2 mg/kg daily x 4 days
Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
429209|NCT00556452|P3|Participant Flow|Clo/BU4 40mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 40 mg/m^2/day x 5 days
Busulfan IV 3.2 mg/kg daily x 4 days
Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
429210|NCT00556452|P2|Participant Flow|Clo/BU4 30mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 30 mg/m^2/day x 5 days
Busulfan IV 3.2 mg/kg daily x 4 days
Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
429211|NCT00556452|P1|Participant Flow|Clo/BU4 20mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 20 mg/m^2/day x 5 days
Busulfan IV 3.2 mg/kg daily x 4 days
Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
429212|NCT00556452|O1|Outcome|Clo/BU4|"Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment.
After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.
Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant
Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels)
1st dose level: 20 mg/m2/day x 5 days
2nd dose level: 30 mg/m2/day x 5 days
3rd dose level: 40 mg/m2/day x 5 days
Busulfan IV 3.2 mg/kg daily x 4 days
Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment"
429213|NCT00556452|O1|Outcome|Clo/BU4|"Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment.
After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.
Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant
Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels)
1st dose level: 20 mg/m2/day x 5 days
2nd dose level: 30 mg/m2/day x 5 days
3rd dose level: 40 mg/m2/day x 5 days
Busulfan IV 3.2 mg/kg daily x 4 days
Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment"
429214|NCT00556452|O1|Outcome|Clo/Bu4|Experimental: Clo/BU4
429215|NCT00556452|E1|Reported Event|Clo/Bu4|
429216|NCT00556478|B3|Baseline|Total|Total of all reporting groups
439652|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
429217|NCT00556478|B2|Baseline|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.
PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429218|NCT00556478|B1|Baseline|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429219|NCT00556478|P2|Participant Flow|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.
PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429220|NCT00556478|P1|Participant Flow|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429221|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.
Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429222|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429223|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.
Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429224|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429380|NCT00559962|P1|Participant Flow|Placebo|Oral placebo every 4 weeks for 12 weeks
439653|NCT00577135|O4|Outcome|High Intensification|
429225|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.
Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429226|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429227|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.
Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429228|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429229|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.
Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429230|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429231|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.
Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429232|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429326|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429233|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.
Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429234|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429235|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.
Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429236|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429237|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.
PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429238|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429239|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.
PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429240|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429370|NCT00559962|B3|Baseline|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
429371|NCT00559962|B2|Baseline|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
429241|NCT00556478|E3|Reported Event|Open Label Phase|"Subjects will all receive PSD502 if they wish to continue in the trial.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429242|NCT00556478|E2|Reported Event|Double-Blind Placebo|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.
PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429243|NCT00556478|E1|Reported Event|Double-Blind Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.
PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
429244|NCT00559507|B1|Baseline|Treatment (Saracatinib)|Patients will receive AZD0530 175mg orally daily for 4 weeks.
429245|NCT00559507|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib 175 mg PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
429246|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
429247|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
429248|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
429249|NCT00559507|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
429250|NCT00559585|B3|Baseline|Total|Total of all reporting groups
429251|NCT00559585|B2|Baseline|Intravenous (IV) Abatacept|Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies.
429252|NCT00559585|B1|Baseline|Subcutaneous (SC) Abatacept|Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies.
429253|NCT00559585|P2|Participant Flow|Intravenous (IV) Abatacept|During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study.
429254|NCT00559585|P1|Participant Flow|Subcutaneous (SC) Abatacept|During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. During the Open Label Long Term (LT) Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study.
429255|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
429256|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
429372|NCT00559962|B1|Baseline|Placebo|Oral placebo every 4 weeks for 12 weeks
429257|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
429258|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
429259|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
429260|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
429261|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
429262|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
429263|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
429264|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
429265|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
429266|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
429267|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429268|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429269|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429270|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429271|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429272|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429273|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429274|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
430373|NCT00561600|O2|Outcome|Pinnacle MoM|Pinnacle metal on metal acetabular cup system
429275|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
429276|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
429277|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429278|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429279|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
429280|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
429281|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429282|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429283|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
429284|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
429285|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429286|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429287|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429288|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429289|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429290|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429291|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429373|NCT00559962|P8|Participant Flow|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
430374|NCT00561600|O1|Outcome|ASR XL|ASR™-XL Acetabular Cup System
429292|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429293|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429294|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429295|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429296|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429297|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
429298|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
429299|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429300|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception
429301|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
429302|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
429303|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (Subcutaneous placebo placebo).
429304|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429305|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429306|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429307|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429308|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429309|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
429310|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
429374|NCT00559962|P7|Participant Flow|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
429311|NCT00559585|E2|Reported Event|SC Abatacept|During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could continue SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study.
429312|NCT00559585|E1|Reported Event|IV Abatacept|During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could switch to SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study.
429313|NCT00559637|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
429314|NCT00559637|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 micrograms per kilogram (mcg/kg) of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
429315|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
429316|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
429317|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
429318|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
429319|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
429320|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
429321|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
429322|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
429323|NCT00559637|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
429324|NCT00559754|B1|Baseline|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429325|NCT00559754|P1|Participant Flow|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|"Participants received doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
Participants then received bevacizumab 15 mg per kilogram (mg/kg) IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles."
429327|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429328|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429329|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429330|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429331|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429332|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429333|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429334|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429335|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429336|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429337|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429338|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429339|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429340|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429341|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429342|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429343|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429344|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429345|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429375|NCT00559962|P6|Participant Flow|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
429376|NCT00559962|P5|Participant Flow|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
429346|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429347|NCT00559754|E1|Reported Event|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
429348|NCT00559897|B1|Baseline|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid
Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
429349|NCT00559897|P1|Participant Flow|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid
Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
429350|NCT00559897|O1|Outcome|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid
Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
429351|NCT00559897|E1|Reported Event|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid
Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
429352|NCT00559936|B1|Baseline|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
429353|NCT00559936|P1|Participant Flow|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
429354|NCT00559936|O1|Outcome|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
429355|NCT00559936|O1|Outcome|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
429356|NCT00559936|E1|Reported Event|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
429357|NCT00559949|B1|Baseline|Arm I|"Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary."
429358|NCT00559949|P1|Participant Flow|Arm I|"Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary."
429359|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
429360|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
429361|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
429362|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
429363|NCT00559949|E1|Reported Event|All Participants|All participants on study.
429364|NCT00559962|B9|Baseline|Total|Total of all reporting groups
429365|NCT00559962|B8|Baseline|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
429366|NCT00559962|B7|Baseline|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
429367|NCT00559962|B6|Baseline|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
429368|NCT00559962|B5|Baseline|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
429369|NCT00559962|B4|Baseline|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
429381|NCT00559962|O8|Outcome|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
429382|NCT00559962|O7|Outcome|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
429383|NCT00559962|O6|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
429384|NCT00559962|O5|Outcome|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
429385|NCT00559962|O4|Outcome|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
429386|NCT00559962|O3|Outcome|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
429387|NCT00559962|O2|Outcome|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
429388|NCT00559962|O1|Outcome|Placebo|Oral placebo every 4 weeks for 12 weeks
429389|NCT00559962|O2|Outcome|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
429390|NCT00559962|O1|Outcome|Placebo|Oral placebo every 4 weeks for 12 weeks
429391|NCT00559962|E8|Reported Event|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
429392|NCT00559962|E7|Reported Event|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
429393|NCT00559962|E6|Reported Event|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
429394|NCT00559962|E5|Reported Event|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
429395|NCT00559962|E4|Reported Event|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
429396|NCT00559962|E3|Reported Event|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
429397|NCT00559962|E2|Reported Event|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
429398|NCT00559962|E1|Reported Event|Placebo|Oral placebo every 4 weeks for 12 weeks
429399|NCT00559988|B3|Baseline|Total|Total of all reporting groups
429400|NCT00559988|B2|Baseline|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
429401|NCT00559988|B1|Baseline|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
429402|NCT00559988|P2|Participant Flow|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
429403|NCT00559988|P1|Participant Flow|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
429404|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
429405|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
429406|NCT00559988|E2|Reported Event|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
429407|NCT00559988|E1|Reported Event|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
429408|NCT00560066|B3|Baseline|Total|Total of all reporting groups
429409|NCT00560066|B2|Baseline|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
429410|NCT00560066|B1|Baseline|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
429411|NCT00560066|P2|Participant Flow|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine.
429412|NCT00560066|P1|Participant Flow|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine.
429413|NCT00560066|O2|Outcome|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
429414|NCT00560066|O1|Outcome|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
429415|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
429416|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
429417|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
429418|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
429419|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
429420|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
429421|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
430375|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
429422|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
429423|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
429424|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
429425|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
429426|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
429427|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
429428|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
429429|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
429430|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
429431|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
429432|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
429433|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
429434|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
429435|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
429436|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
429437|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
429438|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine
429439|NCT00560066|E2|Reported Event|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
429440|NCT00560066|E1|Reported Event|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
429441|NCT00560105|B3|Baseline|Total|Total of all reporting groups
429442|NCT00560105|B2|Baseline|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429443|NCT00560105|B1|Baseline|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429444|NCT00560105|P2|Participant Flow|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429445|NCT00560105|P1|Participant Flow|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429446|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429447|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
430376|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
429448|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429449|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429450|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429451|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429452|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429453|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429454|NCT00560105|E2|Reported Event|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429455|NCT00560105|E1|Reported Event|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
429456|NCT00560235|B4|Baseline|Total|Total of all reporting groups
429457|NCT00560235|B3|Baseline|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
429458|NCT00560235|B2|Baseline|Figitumumab Dose Extension (Phase 1B)|Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
429459|NCT00560235|B1|Baseline|Figitumumab Dose Escalation (Phase 1)|Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
429460|NCT00560235|P3|Participant Flow|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
429461|NCT00560235|P2|Participant Flow|Figitumumab Dose Extension (Phase 1B)|Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
429611|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429462|NCT00560235|P1|Participant Flow|Figitumumab Dose Escalation (Phase 1)|Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
429463|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
429464|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
429465|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
429466|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).
429467|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
429468|NCT00560235|O2|Outcome|Figitumumab 30 mg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
429469|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).
429470|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
429471|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
429472|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
429473|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
429474|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
429475|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
429476|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
429477|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
429478|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
429479|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
429480|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
429481|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
429482|NCT00560235|E8|Reported Event|Figitumumab 30 mg/kg + Rapamycin (Phase 2)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
429483|NCT00560235|E7|Reported Event|Figitumumab 30mg/kg (Phase 2)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle) until unacceptable toxicity or participant withdrawal, for up to 6 cycles.
429484|NCT00560235|E6|Reported Event|Figitumumab 30 mg/kg + Rapamycin Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
429485|NCT00560235|E5|Reported Event|Figitumumab 30 mg/kg + Rapamycin Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
429486|NCT00560235|E4|Reported Event|Figitumumab 20 mg/kg + Rapamycin Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
429487|NCT00560235|E3|Reported Event|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
429488|NCT00560235|E2|Reported Event|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
429489|NCT00560235|E1|Reported Event|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
429490|NCT00560313|B1|Baseline|4CMenB|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
429491|NCT00560313|P1|Participant Flow|4CMenB|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
429492|NCT00560313|O4|Outcome|Men ACWY-CRM (One Dose)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post one dose of Men ACWY vaccine.
429493|NCT00560313|O3|Outcome|4CMenB (Post Dose 3)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 3.
429494|NCT00560313|O2|Outcome|4CMenB (Post Dose 2)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 2.
429612|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429495|NCT00560313|O1|Outcome|4CMenB (Post Dose 1)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 1
429496|NCT00560313|O4|Outcome|MenACWY-CRM (Y)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
429497|NCT00560313|O3|Outcome|MenACWY-CRM (W-135)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
429498|NCT00560313|O2|Outcome|MenACWY-CRM (C)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
429499|NCT00560313|O1|Outcome|MenACWY-CRM (A)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
429500|NCT00560313|O4|Outcome|MenACWY-CRM (Y)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
429501|NCT00560313|O3|Outcome|MenACWY-CRM (W-135)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
429502|NCT00560313|O2|Outcome|MenACWY-CRM (C)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
429503|NCT00560313|O1|Outcome|MenACWY-CRM (A)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
429504|NCT00560313|O3|Outcome|4CMen B (NZ98/254)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254) strain.
429505|NCT00560313|O2|Outcome|4CMenB (5/99)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99) strain
429506|NCT00560313|O1|Outcome|4CMenB (44/76-SL)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
429507|NCT00560313|O3|Outcome|4CMen B (NZ98/254)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254)strain.
429508|NCT00560313|O2|Outcome|4CMenB (5/99)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99)strain
429509|NCT00560313|O1|Outcome|4CMenB (44/76-SL)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
429510|NCT00560313|E4|Reported Event|Men ACWY-CRM|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.
Post dose 1 MenACWY."
429511|NCT00560313|E3|Reported Event|4CMenB (3rd Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.
Post dose 3."
429512|NCT00560313|E2|Reported Event|4CMenB (2nd Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.
Post dose 2."
429513|NCT00560313|E1|Reported Event|4CMenB (1st Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.
Post dose 1."
429514|NCT00560352|B4|Baseline|Total|Total of all reporting groups
429515|NCT00560352|B3|Baseline|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429516|NCT00560352|B2|Baseline|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429517|NCT00560352|B1|Baseline|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429518|NCT00560352|P3|Participant Flow|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429543|NCT00560391|P4|Participant Flow|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429519|NCT00560352|P2|Participant Flow|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429520|NCT00560352|P1|Participant Flow|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429521|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, QD or BID, depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
429522|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429523|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429524|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered BID, with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429525|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, QD or BID, depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
429526|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429527|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429528|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered BID, with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429544|NCT00560391|P3|Participant Flow|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
430377|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
429529|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429530|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429531|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429532|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, once daily (QD) or twice daily (BID), depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
429533|NCT00560352|E3|Reported Event|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429534|NCT00560352|E2|Reported Event|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429535|NCT00560352|E1|Reported Event|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
429536|NCT00560391|B6|Baseline|Total|Total of all reporting groups
429537|NCT00560391|B5|Baseline|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose –finding phase and 13 participants treated in dose expansion phase.
429538|NCT00560391|B4|Baseline|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429539|NCT00560391|B3|Baseline|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429540|NCT00560391|B2|Baseline|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429541|NCT00560391|B1|Baseline|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429542|NCT00560391|P5|Participant Flow|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
429545|NCT00560391|P2|Participant Flow|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429546|NCT00560391|P1|Participant Flow|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429547|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
429548|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429549|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429550|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429551|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429552|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
429553|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429554|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429555|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429556|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429557|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
429558|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429559|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429560|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429561|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429562|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
429563|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429564|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
430378|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
429565|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429566|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429567|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
429568|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429569|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429570|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429571|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429572|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
429573|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429574|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429575|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429576|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429577|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
429578|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429579|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429580|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429581|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429582|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
429583|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429584|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
430379|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
429585|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429586|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429587|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
429588|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429589|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429590|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429591|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429592|NCT00560391|O1|Outcome|All Treated Participants|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
429593|NCT00560391|E5|Reported Event|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429594|NCT00560391|E4|Reported Event|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429595|NCT00560391|E3|Reported Event|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
429596|NCT00560391|E2|Reported Event|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429597|NCT00560391|E1|Reported Event|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
429598|NCT00560404|B3|Baseline|Total|Total of all reporting groups
429599|NCT00560404|B2|Baseline|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429600|NCT00560404|B1|Baseline|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429601|NCT00560404|P2|Participant Flow|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429602|NCT00560404|P1|Participant Flow|C.E.R.A.|Participants received RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A.]) with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429603|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429604|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429605|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429606|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429607|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429608|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429609|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429610|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
430380|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
429613|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429614|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429615|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429616|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429617|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429618|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429619|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429620|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429621|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429622|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429623|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429624|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429625|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429626|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429627|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429628|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429629|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429630|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429631|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429632|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429633|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429634|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429635|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429636|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429637|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429638|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429639|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429640|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429641|NCT00560404|E2|Reported Event|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
429642|NCT00560404|E1|Reported Event|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
429643|NCT00560417|B3|Baseline|Total|Total of all reporting groups
429644|NCT00560417|B2|Baseline|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429645|NCT00560417|B1|Baseline|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429646|NCT00560417|P2|Participant Flow|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429647|NCT00560417|P1|Participant Flow|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429648|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429649|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429650|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429651|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429652|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429653|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429654|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429655|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429656|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429657|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429658|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429659|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429660|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429661|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429662|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429663|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429664|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429665|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429666|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429667|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429668|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429669|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429670|NCT00560417|E2|Reported Event|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
429671|NCT00560417|E1|Reported Event|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
429672|NCT00560508|B3|Baseline|Total|Total of all reporting groups
429673|NCT00560508|B2|Baseline|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429674|NCT00560508|B1|Baseline|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429675|NCT00560508|P2|Participant Flow|Pramipexole Immediate Release Group (PPX IR)|Pramipexole Immediate Release (IR) tablets of 0.125 mg and 0.5 mg dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429676|NCT00560508|P1|Participant Flow|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429677|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
429678|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
429679|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
429680|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
429681|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
429682|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
429683|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
429684|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
429685|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
429686|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
429687|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
429688|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open label period
429689|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429690|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429838|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
429691|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429692|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429693|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day for 12 weeks to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429694|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429695|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day for 12 weeks to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429696|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429697|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429698|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429699|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429700|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429701|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429702|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429703|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429704|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429705|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429706|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429707|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429708|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429709|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429710|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429711|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429712|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429713|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429714|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429715|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429716|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429717|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429718|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429719|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429720|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429721|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429839|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
429722|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429723|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429724|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429725|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429726|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429727|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429728|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429729|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429730|NCT00560508|E2|Reported Event|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
429731|NCT00560508|E1|Reported Event|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
429732|NCT00560560|B3|Baseline|Total|Total of all reporting groups
429733|NCT00560560|B2|Baseline|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429734|NCT00560560|B1|Baseline|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429735|NCT00560560|P2|Participant Flow|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429736|NCT00560560|P1|Participant Flow|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429737|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429738|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429739|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429740|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429741|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429742|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429743|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429744|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429762|NCT00560573|O1|Outcome|Overall Participapnts|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
429745|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429746|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429747|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429748|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429749|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429750|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429751|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429752|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429753|NCT00560560|E2|Reported Event|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429754|NCT00560560|E1|Reported Event|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
429755|NCT00560573|B1|Baseline|All Participants|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
429756|NCT00560573|P6|Participant Flow|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg, was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429757|NCT00560573|P5|Participant Flow|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429758|NCT00560573|P4|Participant Flow|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The recommended phase 2 dose (R2PD) of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429759|NCT00560573|P3|Participant Flow|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429760|NCT00560573|P2|Participant Flow|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429761|NCT00560573|P1|Participant Flow|Figitumumab 6 mg/kg|Figitumumab 6 milligram (mg)/kilogram (kg) was administered intravenously (IV) on Day 1 of each cycle over 2.5 hours (hr) up to 6 cycles. Gemcitabine 1250 mg/meter square (m^2) was administered IV over approximately 30 minutes (min) on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429840|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period.
429763|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
429764|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
429765|NCT00560573|O6|Outcome|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429766|NCT00560573|O5|Outcome|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429767|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429768|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429769|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429770|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429771|NCT00560573|O1|Outcome|Overall Population With PR and CR|Participants with PR and CR who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants with PR and CR who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
429772|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Expansion With Pemetrexed|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429773|NCT00560573|O2|Outcome|Figitumumab 20 mg/kg With Gemcitabine and Cisplatin|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429774|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
429775|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Expansion With Pemetrexed|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429776|NCT00560573|O2|Outcome|Figitumumab 20 mg/kg With Gemcitabine and Cisplatin|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429777|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
429778|NCT00560573|O2|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429809|NCT00560573|E3|Reported Event|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429779|NCT00560573|O1|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429780|NCT00560573|O2|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429781|NCT00560573|O1|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429782|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429783|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429784|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 (absence) and on Day 1 of each cycle (presence) thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429785|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429786|NCT00560573|O4|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429787|NCT00560573|O3|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429788|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429789|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429790|NCT00560573|O4|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429791|NCT00560573|O3|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429792|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429837|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
429964|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
429793|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429794|NCT00560573|O1|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429795|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429796|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429797|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429798|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429799|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429800|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429801|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429802|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429803|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429804|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429805|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429806|NCT00560573|E6|Reported Event|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
429807|NCT00560573|E5|Reported Event|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429808|NCT00560573|E4|Reported Event|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429965|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
429810|NCT00560573|E2|Reported Event|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429811|NCT00560573|E1|Reported Event|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
429812|NCT00560612|B3|Baseline|Total|Total of all reporting groups
429813|NCT00560612|B2|Baseline|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
429814|NCT00560612|B1|Baseline|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).
Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).
Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).
Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).
Week 12: Final study visit (no study medication dispensed)."
429815|NCT00560612|P2|Participant Flow|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
429816|NCT00560612|P1|Participant Flow|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).
Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).
Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).
Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).
Week 12: Final study visit (no study medication dispensed)."
429817|NCT00560612|O2|Outcome|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
429818|NCT00560612|O1|Outcome|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).
Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).
Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).
Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).
Week 12: Final study visit (no study medication dispensed)."
429819|NCT00560612|E2|Reported Event|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
429820|NCT00560612|E1|Reported Event|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).
Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).
Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).
Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).
Week 12: Final study visit (no study medication dispensed)."
429821|NCT00560703|B3|Baseline|Total|Total of all reporting groups
429822|NCT00560703|B2|Baseline|Placebo|Sugar capsule, once per day for 84 days
429823|NCT00560703|B1|Baseline|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
429824|NCT00560703|P2|Participant Flow|Placebo|Sugar capsule, once per day for 84 days
429825|NCT00560703|P1|Participant Flow|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
429826|NCT00560703|O2|Outcome|Placebo|Sugar capsule, once per day for 84 days
429827|NCT00560703|O1|Outcome|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
429828|NCT00560703|O2|Outcome|Placebo|Sugar capsule, once per day for 84 days
429829|NCT00560703|O1|Outcome|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
429830|NCT00560703|E2|Reported Event|Placebo|Sugar capsule, once per day for 84 days
429831|NCT00560703|E1|Reported Event|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
429832|NCT00560794|B1|Baseline|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
429833|NCT00560794|P1|Participant Flow|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
429834|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
429835|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
429836|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
429841|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period.
429842|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
429843|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
429844|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
429845|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
429846|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
429847|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
429848|NCT00560794|E1|Reported Event|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
429849|NCT00560833|B6|Baseline|Total|Total of all reporting groups
429850|NCT00560833|B5|Baseline|Esmertazapine 18 mg|Participants receive esmertazapine 18 mg, encapsulated tablet, PO, QD for up to 12 weeks
429851|NCT00560833|B4|Baseline|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
429852|NCT00560833|B3|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
429853|NCT00560833|B2|Baseline|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
429854|NCT00560833|B1|Baseline|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
429855|NCT00560833|P5|Participant Flow|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
429856|NCT00560833|P4|Participant Flow|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
429857|NCT00560833|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
429858|NCT00560833|P2|Participant Flow|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
429859|NCT00560833|P1|Participant Flow|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
429860|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
429861|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
429862|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
429863|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
429864|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
429865|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
429866|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
429867|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
429868|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
429869|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
429870|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
429871|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
429872|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
429873|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
429874|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
429875|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
429876|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
430088|NCT00561353|B11|Baseline|Total|Total of all reporting groups
429877|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
429878|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
429879|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
429880|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
429881|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
429882|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
429883|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
429884|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
429885|NCT00560833|E5|Reported Event|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
429886|NCT00560833|E4|Reported Event|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
429887|NCT00560833|E3|Reported Event|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
429888|NCT00560833|E2|Reported Event|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
429889|NCT00560833|E1|Reported Event|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
429890|NCT00560859|B3|Baseline|Total|Total of all reporting groups
429891|NCT00560859|B2|Baseline|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
429892|NCT00560859|B1|Baseline|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
429893|NCT00560859|P2|Participant Flow|Watchful Waiting|"Children will be closely monitored during the primary 7 month monitoring period and will be re-evaluated for AT by an otolaryngologist at the end of that period. a
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
429894|NCT00560859|P1|Participant Flow|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
429895|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
429896|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
429897|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
429898|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
429899|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored during the primary 7-month monitoring period and re-evaluated for AT by an otolaryngologist after that period.
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
429900|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
429901|NCT00560859|E2|Reported Event|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
429902|NCT00560859|E1|Reported Event|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.
Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
429903|NCT00560885|B1|Baseline|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
429904|NCT00560885|P1|Participant Flow|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
429905|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
429906|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
429907|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
430381|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
429908|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
429909|NCT00560885|E1|Reported Event|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
429910|NCT00560937|B3|Baseline|Total|Total of all reporting groups
429911|NCT00560937|B2|Baseline|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
429912|NCT00560937|B1|Baseline|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
429913|NCT00560937|P2|Participant Flow|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
429914|NCT00560937|P1|Participant Flow|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
429915|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
429916|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
429917|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
429918|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
429919|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
429920|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
429921|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
429922|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
429923|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
429924|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
429925|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
429926|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
429927|NCT00560937|E2|Reported Event|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
429928|NCT00560937|E1|Reported Event|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then
Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then
Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
429929|NCT00560950|B3|Baseline|Total|Total of all reporting groups
429930|NCT00560950|B2|Baseline|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
429931|NCT00560950|B1|Baseline|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
429932|NCT00560950|P2|Participant Flow|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
429933|NCT00560950|P1|Participant Flow|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
429934|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
429935|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
429936|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
429937|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
429938|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
429939|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
429940|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
429941|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
429942|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
429943|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
429944|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
429945|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
429946|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
429947|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
429948|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
429949|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
429950|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
429951|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
429952|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
429953|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
429954|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
429955|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
429956|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
429957|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
429958|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
429959|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
429960|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
429961|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
429962|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
429963|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
429966|NCT00560950|E2|Reported Event|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
429967|NCT00560950|E1|Reported Event|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
429968|NCT00561002|B3|Baseline|Total|Total of all reporting groups
429969|NCT00561002|B2|Baseline|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
429970|NCT00561002|B1|Baseline|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
429971|NCT00561002|P2|Participant Flow|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
429972|NCT00561002|P1|Participant Flow|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
429973|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
429974|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
429975|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
429976|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
429977|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
429978|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
429979|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
429980|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
429981|NCT00561002|E2|Reported Event|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
429982|NCT00561002|E1|Reported Event|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
429983|NCT00561015|B7|Baseline|Total|Total of all reporting groups
429984|NCT00561015|B6|Baseline|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
429985|NCT00561015|B5|Baseline|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
429986|NCT00561015|B4|Baseline|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
429987|NCT00561015|B3|Baseline|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
429988|NCT00561015|B2|Baseline|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
429989|NCT00561015|B1|Baseline|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430089|NCT00561353|B10|Baseline|TMC435 200 mg (Cohort 5)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430382|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430383|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
429990|NCT00561015|P6|Participant Flow|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
429991|NCT00561015|P5|Participant Flow|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
429992|NCT00561015|P4|Participant Flow|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
429993|NCT00561015|P3|Participant Flow|Pbo With Peg-IFN-alfa-2a+ RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
429994|NCT00561015|P2|Participant Flow|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
429995|NCT00561015|P1|Participant Flow|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis (inflammation of liver) C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
429996|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
429997|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
429998|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
429999|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430000|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430001|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430090|NCT00561353|B9|Baseline|Placebo (Cohort 4)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430384|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430002|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430003|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430004|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430005|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430006|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430007|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430008|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430009|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430010|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430011|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430012|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430013|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430091|NCT00561353|B8|Baseline|TMC435 200 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430092|NCT00561353|B7|Baseline|TMC435 150 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430014|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430015|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430016|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430017|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430018|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430019|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430020|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430021|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430022|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430023|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430024|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430025|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430093|NCT00561353|B6|Baseline|TMC435 75 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430308|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430026|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430027|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430028|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430029|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430030|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430031|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430032|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430033|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430034|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430035|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430036|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430037|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430122|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430364|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430038|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430039|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430040|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430041|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430042|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430043|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430044|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430045|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430046|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430047|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430048|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430049|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430094|NCT00561353|B5|Baseline|Placebo (Cohort 2)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430050|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430051|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430052|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a on + RBV (T2/PR24) - Genotype 3|Participants who were never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430053|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430054|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430055|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430056|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430057|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430058|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430059|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430060|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430061|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430095|NCT00561353|B4|Baseline|TMC435 200 mg (Cohort 2)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430062|NCT00561015|E6|Reported Event|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430063|NCT00561015|E5|Reported Event|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430064|NCT00561015|E4|Reported Event|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430065|NCT00561015|E3|Reported Event|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430066|NCT00561015|E2|Reported Event|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
430067|NCT00561015|E1|Reported Event|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
430068|NCT00561145|B3|Baseline|Total|Total of all reporting groups
430069|NCT00561145|B2|Baseline|Elderly Men|Elderly men: 65-85 years of age
430070|NCT00561145|B1|Baseline|Young Men|Young men: 20-40 years of age
430071|NCT00561145|P2|Participant Flow|Elderly Men|"Elderly men should be 65-85 years of age. Men will be excluded based on the following exclusion criteria:
body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome."
430072|NCT00561145|P1|Participant Flow|Young Men|"Young men should be 20-40 years of age. Men will be excluded based on the following exclusion criteria:
body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome."
430073|NCT00561145|O2|Outcome|Elderly Men|Elderly men: 65-85 years of age
430074|NCT00561145|O1|Outcome|Young Men|Young men: 20-40 years of age
430075|NCT00561145|E2|Reported Event|Elderly Men|Elderly men: 65-85 years of age
430076|NCT00561145|E1|Reported Event|Young Men|Young men: 20-40 years of age
430077|NCT00561340|B3|Baseline|Total|Total of all reporting groups
430078|NCT00561340|B2|Baseline|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling
Nutritional counseling: 50% randomized to nutritional counseling only"
430079|NCT00561340|B1|Baseline|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling
Pediasure: 50% will be randomized to pediasure with nutritional counseling"
430080|NCT00561340|P2|Participant Flow|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling
Nutritional counseling: 50% randomized to nutritional counseling only"
430081|NCT00561340|P1|Participant Flow|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling
Pediasure: 50% will be randomized to pediasure with nutritional counseling"
430082|NCT00561340|O2|Outcome|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling
Nutritional counseling: 50% randomized to nutritional counseling only"
430083|NCT00561340|O1|Outcome|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling
Pediasure: 50% will be randomized to pediasure with nutritional counseling"
430084|NCT00561340|O2|Outcome|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling
Nutritional counseling: 50% randomized to nutritional counseling only"
430085|NCT00561340|O1|Outcome|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling
Pediasure: 50% will be randomized to pediasure with nutritional counseling"
430086|NCT00561340|E2|Reported Event|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling
Nutritional counseling: 50% randomized to nutritional counseling only"
430087|NCT00561340|E1|Reported Event|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling
Pediasure: 50% will be randomized to pediasure with nutritional counseling"
430096|NCT00561353|B3|Baseline|Placebo (Cohort 1)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430097|NCT00561353|B2|Baseline|TMC435 75mg (Cohort 1)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430098|NCT00561353|B1|Baseline|TMC435 25 mg (Cohort 1)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430099|NCT00561353|P10|Participant Flow|TMC435 200 mg (Cohort 5/Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430100|NCT00561353|P9|Participant Flow|Placebo (Cohort 4/Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430101|NCT00561353|P8|Participant Flow|TMC435 200 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430102|NCT00561353|P7|Participant Flow|TMC435 150 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430103|NCT00561353|P6|Participant Flow|TMC435 75 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430104|NCT00561353|P5|Participant Flow|Placebo (Cohort 2/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430105|NCT00561353|P4|Participant Flow|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430106|NCT00561353|P3|Participant Flow|Placebo (Cohort 1/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430107|NCT00561353|P2|Participant Flow|TMC435 75mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430108|NCT00561353|P1|Participant Flow|TMC435 25 mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430109|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430110|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430111|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430112|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430113|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430114|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430115|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430116|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430117|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430118|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
430119|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430120|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430121|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430365|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430123|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430124|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430125|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430126|NCT00561353|O3|Outcome|TTMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430127|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430128|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
430129|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430130|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430131|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430132|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430133|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430134|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430135|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430136|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430137|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430138|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
430139|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430140|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430141|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430142|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon (PegIFNα-2a) on Days 1, 8, 15, and 22.
430143|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430144|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430145|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430146|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430147|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430148|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
430149|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430150|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430151|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430152|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430153|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430366|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430154|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430155|NCT00561353|O4|Outcome|TMC435 200mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430156|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by Placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430157|NCT00561353|O2|Outcome|TMC435 75mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430158|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430159|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers in Cohort 5, Panel D received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430160|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo identical in appearance to TMC435 75 mg, 150 mg, or 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430161|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430162|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430163|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430164|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430165|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430166|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by Placebo once daily coadministered with RBV for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430167|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430168|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430169|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430170|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo identical in appearance to TMC435 75 mg, 150 mg, or 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430171|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430172|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430173|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430174|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panels A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430175|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panels A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430176|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panels A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430367|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430177|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panels A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430178|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panels A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430179|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430180|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430181|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430182|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430183|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430184|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430185|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430186|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430187|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430188|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430189|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430190|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430191|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo identical in appearance toTMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430192|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430193|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
430194|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430195|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430196|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430197|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430198|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430199|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430200|NCT00561353|O4|Outcome|TMC435 200mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430201|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430202|NCT00561353|O2|Outcome|TMC435 75mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430232|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430203|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
430204|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430205|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430206|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430207|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430208|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430209|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430210|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430211|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg and 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430212|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430213|NCT00561353|O1|Outcome|TMC435 25 (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430214|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants in received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430215|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430216|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430217|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430218|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
430219|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430220|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430221|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430222|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430223|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430224|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430225|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430226|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430227|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430228|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430229|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants in received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430230|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430231|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430368|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430233|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
430234|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430235|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430236|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430237|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430238|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430239|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430240|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430241|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430242|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430243|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
430244|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430245|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430246|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430247|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
430248|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
430249|NCT00561353|E11|Reported Event|All TMC435 (All Cohorts)|
430250|NCT00561353|E10|Reported Event|TMC435 200 mg (Cohort 5/Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430251|NCT00561353|E9|Reported Event|Placebo (Cohort 4/Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430252|NCT00561353|E8|Reported Event|TMC435 200 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430253|NCT00561353|E7|Reported Event|TMC435 150 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430254|NCT00561353|E6|Reported Event|TMC435 75 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
430255|NCT00561353|E5|Reported Event|Placebo (Cohort 2/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430256|NCT00561353|E4|Reported Event|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430257|NCT00561353|E3|Reported Event|Placebo (Cohort 1/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430258|NCT00561353|E2|Reported Event|TMC435 75mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430259|NCT00561353|E1|Reported Event|TMC435 25 mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
430369|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430370|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430260|NCT00561392|B1|Baseline|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430261|NCT00561392|P1|Participant Flow|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430262|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430263|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430264|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430265|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430266|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430267|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430268|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430269|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430270|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430271|NCT00561392|E1|Reported Event|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
430272|NCT00561418|B1|Baseline|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.
vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.
Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
430273|NCT00561418|P1|Participant Flow|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.
vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.
Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post Hematopoietic Stem Cell Transplantation),days +56 to +66 (≈2 mos), and at Cycle 2 Day 1 (≈3 mos.), Cycle 3 Day 1 (≈4 mos.), Cycle 5 Day 1 (≈6 mos.),Cycle 7 Day 1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
430274|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.
vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.
Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
430275|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.
vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.
Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
430307|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430371|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430276|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.
vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.
Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
430277|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.
vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.
Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
430278|NCT00561418|E1|Reported Event|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.
vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.
Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
430279|NCT00561431|B3|Baseline|Total|Total of all reporting groups
430280|NCT00561431|B2|Baseline|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
430281|NCT00561431|B1|Baseline|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
430282|NCT00561431|P2|Participant Flow|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
430283|NCT00561431|P1|Participant Flow|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
430284|NCT00561431|O2|Outcome|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
430285|NCT00561431|O1|Outcome|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
430286|NCT00561431|O2|Outcome|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
430287|NCT00561431|O1|Outcome|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
430288|NCT00561431|E2|Reported Event|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
430289|NCT00561431|E1|Reported Event|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
430290|NCT00561457|B1|Baseline|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
430291|NCT00561457|P1|Participant Flow|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
430292|NCT00561457|O1|Outcome|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
430293|NCT00561457|E1|Reported Event|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
430294|NCT00561470|B3|Baseline|Total|Total of all reporting groups
430295|NCT00561470|B2|Baseline|Aflibercept/Folfiri|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
430296|NCT00561470|B1|Baseline|Placebo/Folfiri|Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
430297|NCT00561470|P2|Participant Flow|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430298|NCT00561470|P1|Participant Flow|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430299|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Aflibercept and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
430300|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
430301|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430302|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430303|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430304|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430305|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430306|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430309|NCT00561470|E2|Reported Event|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430310|NCT00561470|E1|Reported Event|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
430311|NCT00561574|B3|Baseline|Total|Total of all reporting groups
430312|NCT00561574|B2|Baseline|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430313|NCT00561574|B1|Baseline|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430314|NCT00561574|P2|Participant Flow|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430315|NCT00561574|P1|Participant Flow|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430316|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430317|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430318|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430319|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430320|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430321|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430322|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430323|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430324|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430325|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430326|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430327|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430328|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430329|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430330|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430331|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430332|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430333|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430334|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430335|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430336|NCT00561574|E2|Reported Event|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
430337|NCT00561574|E1|Reported Event|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
430338|NCT00561600|B3|Baseline|Total|Total of all reporting groups
430339|NCT00561600|B2|Baseline|Pinnacle MoM|Pinnacle metal on metal acetabular cup system
430340|NCT00561600|B1|Baseline|ASR XL|ASR™-XL Acetabular Cup System
430341|NCT00561600|P2|Participant Flow|B Pinnacle™|Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
430342|NCT00561600|P1|Participant Flow|A ASR™-XL|ASR™-XL Modular Acetabular Cup System stem
430343|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430344|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430345|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430346|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430347|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430348|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430349|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430350|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430351|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430352|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430353|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430354|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430355|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430356|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430357|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430358|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430359|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430360|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430361|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430362|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
430363|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
430402|NCT00561652|B2|Baseline|Arm 2|Chiropractic treatment plus Education plus exercise
430403|NCT00561652|B1|Baseline|Arm 1|Education plus exercise
430404|NCT00561652|P2|Participant Flow|Arm 2|Chiropractic treatment plus education plus exercise
430405|NCT00561652|P1|Participant Flow|Arm 1|Education plus exercise
430406|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
430407|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
430408|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
430409|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
430410|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
430411|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
430412|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
430413|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
430414|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
430415|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
430416|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
430417|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
430418|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
430419|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
430420|NCT00561652|E2|Reported Event|Arm 2|Chiropractic treatment plus education plus exercise
430421|NCT00561652|E1|Reported Event|Arm 1|Education plus exercise
430422|NCT00561678|B3|Baseline|Total|Total of all reporting groups
430423|NCT00561678|B2|Baseline|Placebo|Placebo - normal saline 0.5/ug/kg/hr
430424|NCT00561678|B1|Baseline|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
430425|NCT00561678|P2|Participant Flow|Placebo|Placebo - normal saline 0.5/ug/kg/hr
430426|NCT00561678|P1|Participant Flow|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
430427|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
430428|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
430429|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
430430|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
430431|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
430432|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
430433|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
430434|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
430435|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
430436|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
430437|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
430438|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
430439|NCT00561678|E2|Reported Event|Placebo|Placebo - normal saline 0.5/ug/kg/hr
430440|NCT00561678|E1|Reported Event|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
430441|NCT00561730|B1|Baseline|Pantoprazole|All patients enrolled
430442|NCT00561730|P1|Participant Flow|Pantoprazole|All patients enrolled
430443|NCT00561730|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
430444|NCT00561730|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
430445|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
430446|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
430447|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
430448|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
430449|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
430450|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
430451|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
430452|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
430453|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
430454|NCT00561730|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
430455|NCT00561795|B3|Baseline|Total|Total of all reporting groups
430456|NCT00561795|B2|Baseline|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430457|NCT00561795|B1|Baseline|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430458|NCT00561795|P4|Participant Flow|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430459|NCT00561795|P3|Participant Flow|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430460|NCT00561795|P2|Participant Flow|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430461|NCT00561795|P1|Participant Flow|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430462|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430463|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430464|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430465|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430466|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430467|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430468|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430469|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430470|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430471|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430472|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430473|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430474|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430475|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430476|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430477|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430478|NCT00561795|E2|Reported Event|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
430479|NCT00561795|E1|Reported Event|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
430480|NCT00561821|B5|Baseline|Total|Total of all reporting groups
430481|NCT00561821|B4|Baseline|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430482|NCT00561821|B3|Baseline|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430483|NCT00561821|B2|Baseline|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430484|NCT00561821|B1|Baseline|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430485|NCT00561821|P4|Participant Flow|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430486|NCT00561821|P3|Participant Flow|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430487|NCT00561821|P2|Participant Flow|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430488|NCT00561821|P1|Participant Flow|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430489|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430490|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430491|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430492|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430493|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430494|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430495|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430496|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430497|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430498|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430499|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430500|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430501|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430502|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430503|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430504|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430505|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430506|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430507|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430508|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430509|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430510|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430511|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430512|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430513|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430514|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430515|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430516|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430517|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430518|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430519|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430520|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430521|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430522|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430523|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430524|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430525|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430526|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430527|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430528|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430529|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430530|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430531|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430532|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430533|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430534|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430535|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430536|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430537|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430538|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430539|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430540|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430541|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430542|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430543|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430544|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430545|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430546|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430547|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430548|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430549|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430550|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430551|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430552|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430553|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430554|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430555|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430556|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430557|NCT00561821|E4|Reported Event|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
430558|NCT00561821|E3|Reported Event|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430559|NCT00561821|E2|Reported Event|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430560|NCT00561821|E1|Reported Event|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
430561|NCT00561834|B1|Baseline|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
430562|NCT00561834|P1|Participant Flow|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
430563|NCT00561834|O1|Outcome|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
430564|NCT00561834|E1|Reported Event|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
430565|NCT00561912|B1|Baseline|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
430566|NCT00561912|P1|Participant Flow|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
430567|NCT00561912|O1|Outcome|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
430568|NCT00561912|E1|Reported Event|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
430569|NCT00561925|B4|Baseline|Total|Total of all reporting groups
430570|NCT00561925|B3|Baseline|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
430571|NCT00561925|B2|Baseline|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
430572|NCT00561925|B1|Baseline|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
430573|NCT00561925|P5|Participant Flow|NVP IR to XR|
430574|NCT00561925|P4|Participant Flow|NVP XR|
430575|NCT00561925|P3|Participant Flow|NVP XR 400mg QD|Nevirapine extended release 400 mg given once daily
430576|NCT00561925|P2|Participant Flow|NVP IR 200mg BID|Nevirapine immediate release 200 mg given twice daily
430577|NCT00561925|P1|Participant Flow|NVP IR 200mg QD|Nevirapine immediate release 200 mg given once daily
430578|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension who had previously received nevirapine IR during the pre week 144
430579|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
430580|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
430581|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
430582|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
430583|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
430584|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
430585|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
430586|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
430587|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
430588|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
430589|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
430590|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
430591|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
430592|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
430593|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
430594|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
430595|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
430596|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
430597|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase and nevirapine XR during open label extension
430598|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
430599|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
430600|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
430601|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase and nevirapine XR during open label extension
430602|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
430603|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
430604|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
430605|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
430606|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
430607|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
430608|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
439654|NCT00577135|O3|Outcome|Low Intensification|
430609|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
430610|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
430611|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
430612|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
430613|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
430614|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
430615|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
430616|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
430617|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
430618|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
430619|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
430620|NCT00561925|E5|Reported Event|NVP XR-IR/XR|Patients receiving nevirapine XR during open label extension who had previously receiving nevirapine IR during the pre week 144
430621|NCT00561925|E4|Reported Event|NVP IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
430622|NCT00561925|E3|Reported Event|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
430623|NCT00561925|E2|Reported Event|NVP IR|Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
430624|NCT00561925|E1|Reported Event|NVP IR 200mg QD|Nevirapine immediate release 200 mg given once daily
430625|NCT00561951|B4|Baseline|Total|Total of all reporting groups
430626|NCT00561951|B3|Baseline|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430627|NCT00561951|B2|Baseline|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430628|NCT00561951|B1|Baseline|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430629|NCT00561951|P3|Participant Flow|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430630|NCT00561951|P2|Participant Flow|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430631|NCT00561951|P1|Participant Flow|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430632|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430633|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430634|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430635|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430636|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430637|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430638|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430639|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430640|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430641|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430642|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430643|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430644|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430645|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430646|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430647|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430648|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430649|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430650|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430651|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430652|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430653|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430654|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430655|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430656|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430657|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430658|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430659|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430660|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430661|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430662|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430663|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430664|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430665|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430666|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430667|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430668|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430669|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430670|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430671|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430672|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430673|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430674|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430675|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430676|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430677|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430678|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430679|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430680|NCT00561951|E3|Reported Event|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
430681|NCT00561951|E2|Reported Event|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
430682|NCT00561951|E1|Reported Event|Placebo|Subjects were treated with placebo once daily for 12 weeks.
430683|NCT00552032|B3|Baseline|Total|Total of all reporting groups
430684|NCT00552032|B2|Baseline|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430685|NCT00552032|B1|Baseline|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430686|NCT00552032|P2|Participant Flow|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430687|NCT00552032|P1|Participant Flow|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430688|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430689|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430690|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430691|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430692|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430693|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430694|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430695|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430696|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430697|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430698|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430699|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430700|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430701|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430702|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430703|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430704|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430740|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430705|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430706|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430707|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430708|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430709|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430710|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430711|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430712|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430713|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430714|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430715|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430716|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430717|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430718|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430719|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430720|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430721|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430722|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430723|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430724|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430725|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430726|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430727|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430728|NCT00552032|E2|Reported Event|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430729|NCT00552032|E1|Reported Event|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
430730|NCT00552058|B3|Baseline|Total|Total of all reporting groups
430731|NCT00552058|B2|Baseline|Placebo|Placebo, saline solution for sc injection
430732|NCT00552058|B1|Baseline|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430733|NCT00552058|P2|Participant Flow|Placebo|Placebo, saline solution for sc injection
430734|NCT00552058|P1|Participant Flow|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430735|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430736|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430737|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430738|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430739|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430741|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430742|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430743|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430744|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430745|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430746|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430747|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430748|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430749|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430750|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430751|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430752|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430753|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430754|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430755|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430756|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430757|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430758|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430759|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430760|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430761|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430762|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430763|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430764|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430765|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430766|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430767|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
430768|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430769|NCT00552058|E2|Reported Event|Placebo|Placebo, saline solution for sc injection
430770|NCT00552058|E1|Reported Event|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
430771|NCT00552084|B3|Baseline|Total|Total of all reporting groups
430772|NCT00552084|B2|Baseline|Placebo|"corn oil taken daily for 24 weeks
Placebo: Placebo supplements will be taken daily for 24 weeks."
430773|NCT00552084|B1|Baseline|Fish Oil|"4 grams fish oil daily for 24 weeks
Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
430774|NCT00552084|P2|Participant Flow|Placebo|"corn oil taken daily for 24 weeks
Placebo: Placebo supplements will be taken daily for 24 weeks."
430775|NCT00552084|P1|Participant Flow|Fish Oil|"4 grams fish oil daily for 24 weeks
Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
430776|NCT00552084|O2|Outcome|Placebo|"corn oil taken daily for 24 weeks
Placebo: Placebo supplements will be taken daily for 24 weeks."
430777|NCT00552084|O1|Outcome|Fish Oil|"4 grams fish oil daily for 24 weeks
Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
430778|NCT00552084|E2|Reported Event|Placebo|"corn oil taken daily for 24 weeks
Placebo: Placebo supplements will be taken daily for 24 weeks."
430779|NCT00552084|E1|Reported Event|Fish Oil|"4 grams fish oil daily for 24 weeks
Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
430780|NCT00552110|B6|Baseline|Total|Total of all reporting groups
430781|NCT00552110|B5|Baseline|Placebo|Placebo nasal spray
430782|NCT00552110|B4|Baseline|Oxymetazoline|OXY twice daily
430783|NCT00552110|B3|Baseline|Mometasone|MFNS once daily
430784|NCT00552110|B2|Baseline|Combination3|MFNS with OXY 3 sprays once daily
430785|NCT00552110|B1|Baseline|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
430786|NCT00552110|P5|Participant Flow|Placebo|Placebo nasal spray
430787|NCT00552110|P4|Participant Flow|Oxymetazoline|OXY twice daily
430788|NCT00552110|P3|Participant Flow|Mometasone|MFNS once daily
430789|NCT00552110|P2|Participant Flow|Combination3|MFNS with OXY 3 sprays once daily
430790|NCT00552110|P1|Participant Flow|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
430791|NCT00552110|O5|Outcome|Placebo|Placebo nasal spray
430792|NCT00552110|O4|Outcome|Oxymetazoline|OXY twice daily
430793|NCT00552110|O3|Outcome|Mometasone|MFNS once daily
430794|NCT00552110|O2|Outcome|Combination3|MFNS with OXY 3 sprays once daily
430795|NCT00552110|O1|Outcome|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
430796|NCT00552110|O5|Outcome|Placebo|Placebo nasal spray
430797|NCT00552110|O4|Outcome|Oxymetazoline|OXY twice daily
430798|NCT00552110|O3|Outcome|Mometasone|MFNS once daily
430799|NCT00552110|O2|Outcome|Combination3|MFNS with OXY 3 sprays once daily
430800|NCT00552110|O1|Outcome|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
430801|NCT00552110|E5|Reported Event|Placebo|Placebo nasal spray
430802|NCT00552110|E4|Reported Event|Oxymetazoline|OXY twice daily
430803|NCT00552110|E3|Reported Event|Mometasone|MFNS once daily
430804|NCT00552110|E2|Reported Event|Combination3|MFNS with OXY 3 sprays once daily
430805|NCT00552110|E1|Reported Event|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
430806|NCT00552175|B4|Baseline|Total|Total of all reporting groups
430807|NCT00552175|B3|Baseline|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
430808|NCT00552175|B2|Baseline|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
430809|NCT00552175|B1|Baseline|Placebo|placebo comparator taken orally every day
430810|NCT00552175|P3|Participant Flow|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
430811|NCT00552175|P2|Participant Flow|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
430812|NCT00552175|P1|Participant Flow|Placebo|placebo comparator taken orally every day
430813|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
430814|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
430815|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430816|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
430817|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430818|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
430819|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
430820|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430821|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
430822|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430823|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
430824|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
430825|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430826|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
430827|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430828|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
430829|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
430830|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430831|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
430832|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430833|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
430834|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
430835|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430836|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
430837|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430838|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
430839|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
430840|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430841|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
430842|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
430843|NCT00552175|E3|Reported Event|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
430844|NCT00552175|E2|Reported Event|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
430845|NCT00552175|E1|Reported Event|Placebo|placebo comparator taken orally every day
430846|NCT00552188|B3|Baseline|Total|Total of all reporting groups
430847|NCT00552188|B2|Baseline|Placebo|Matching placebo
430848|NCT00552188|B1|Baseline|VIA-2291|VIA-2291 100mg
430849|NCT00552188|P2|Participant Flow|Placebo|Matching placebo
430850|NCT00552188|P1|Participant Flow|VIA-2291|VIA-2291 100mg
430851|NCT00552188|O2|Outcome|Placebo|Matching placebo
430852|NCT00552188|O1|Outcome|VIA-2291|VIA-2291 100mg
430853|NCT00552188|O2|Outcome|Placebo|Matching placebo
430854|NCT00552188|O1|Outcome|VIA-2291|VIA-2291 100mg
430855|NCT00552188|E2|Reported Event|Placebo|Matching placebo
430856|NCT00552188|E1|Reported Event|VIA-2291|VIA-2291 100mg
430857|NCT00552240|B3|Baseline|Total|Total of all reporting groups
430858|NCT00552240|B2|Baseline|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430859|NCT00552240|B1|Baseline|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430860|NCT00552240|P2|Participant Flow|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430861|NCT00552240|P1|Participant Flow|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430862|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430863|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430864|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430865|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430866|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430867|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430868|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430869|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430870|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430871|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430872|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430873|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430874|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430875|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430876|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430877|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430878|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430879|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430880|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430881|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430882|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430883|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430884|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430885|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430886|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430887|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430888|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430889|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430890|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430891|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430892|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430893|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430894|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430895|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430896|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430897|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430898|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430899|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430900|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430901|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430902|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430903|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430904|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430905|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430906|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430907|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430908|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430909|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430910|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430911|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430912|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430913|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430914|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430915|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430916|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430917|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430918|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430919|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430920|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430921|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430922|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430923|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430924|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430925|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430926|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430927|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
431059|NCT00552409|O2|Outcome|Placebo|One softgel daily for one year
430928|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430929|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430930|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430931|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430932|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430933|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430934|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430935|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430936|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430937|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430938|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430939|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430940|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430941|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430942|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430943|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430944|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430945|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430946|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430947|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430948|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430949|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430950|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430951|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430952|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430953|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430954|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430955|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430956|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430957|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430958|NCT00552240|E2|Reported Event|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
430959|NCT00552240|E1|Reported Event|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
430960|NCT00552279|B3|Baseline|Total|Total of all reporting groups
430961|NCT00552279|B2|Baseline|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430962|NCT00552279|B1|Baseline|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430963|NCT00552279|P2|Participant Flow|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430964|NCT00552279|P1|Participant Flow|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430965|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430966|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430967|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430968|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430969|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430970|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430971|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430972|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430973|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430974|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430975|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430976|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430977|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
439655|NCT00577135|O2|Outcome|Continuous Infusion|
430978|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430979|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430980|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430981|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430982|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430983|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430984|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430985|NCT00552279|E2|Reported Event|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
430986|NCT00552279|E1|Reported Event|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
430987|NCT00552305|B1|Baseline|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
430988|NCT00552305|P1|Participant Flow|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
430989|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
430990|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
430991|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
430992|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
430993|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
430994|NCT00552305|E1|Reported Event|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
430995|NCT00552344|B1|Baseline|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
430996|NCT00552344|P1|Participant Flow|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
430997|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
430998|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
430999|NCT00552344|O1|Outcome|Certolizumab Pegol (Intention-to-Treat)|"Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection."
431000|NCT00552344|O1|Outcome|Certolizumab Pegol (Intention-to-Treat)|"Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection."
431001|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
431002|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
431003|NCT00552344|E1|Reported Event|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
431004|NCT00552396|B8|Baseline|Total|Total of all reporting groups
431005|NCT00552396|B7|Baseline|3 mg/kg|
431006|NCT00552396|B6|Baseline|1 mg/kg|
431007|NCT00552396|B5|Baseline|0.3 mg/kg|
431008|NCT00552396|B4|Baseline|0.075 mg/kg|
431009|NCT00552396|B3|Baseline|0.015 mg/kg|
431010|NCT00552396|B2|Baseline|0.003 mg/kg|
431011|NCT00552396|B1|Baseline|0.0003 mg/kg|
431012|NCT00552396|P7|Participant Flow|3 mg/kg|
431013|NCT00552396|P6|Participant Flow|1 mg/kg|
431014|NCT00552396|P5|Participant Flow|0.3 mg/kg|
431015|NCT00552396|P4|Participant Flow|0.075 mg/kg|
431016|NCT00552396|P3|Participant Flow|0.015 mg/kg|
431017|NCT00552396|P2|Participant Flow|0.003 mg/kg|
431018|NCT00552396|P1|Participant Flow|0.0003 mg/kg|3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.
431019|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
431020|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
431021|NCT00552396|O5|Outcome|IPH2101 0.3 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
431022|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
431023|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
431024|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
431025|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
431026|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|IV 1 hour infusion
431027|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|IV 1 hour infusion
431028|NCT00552396|O5|Outcome|IPH2101 0.3mg/kg|IV 1 hour infusion
431029|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|IV 1 hour infusion
431030|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|IV bolus injection
431031|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|IV bolus injection
431032|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|IV bolus injection
431033|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|IV 1 hour infusion
431034|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|IV 1 hour infusion
431035|NCT00552396|O5|Outcome|IPH2101 0.3 mg/kg|IV 1 hour infusion
431036|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|IV 1 hour infusion
431037|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|IV Bolus
431038|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|IV Bolus
431039|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|IV Bolus
431040|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|Participants were administered an IV dose of 3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level.If MTD this is not reached at 3mg/kg, 7 subjects will be enrolled at this dose to obtain more data from a larger subject pool to better evaluate safety, PK, PD and signs of efficacy.
431041|NCT00552396|O6|Outcome|IPH2101 1mg/kg|Participants were administered an IV dose of 1 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
431042|NCT00552396|O5|Outcome|IPH2101 0.3mg/kg|Participants were administered an IV dose of 0.3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
431043|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|Participants were administered an IV dose of 0.075 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
431044|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|Participants were administered an IV dose of 0.015 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
431045|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|Participants were administered an IV dose of 0.003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
431046|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|Participants were administered an IV dose of 0.0003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
431047|NCT00552396|E7|Reported Event|3 mg/kg|
431048|NCT00552396|E6|Reported Event|1 mg/kg|
431049|NCT00552396|E5|Reported Event|0.3 mg/kg|
431050|NCT00552396|E4|Reported Event|0.075 mg/kg|
431051|NCT00552396|E3|Reported Event|0.015 mg/kg|
431052|NCT00552396|E2|Reported Event|0.003 mg/kg|
431053|NCT00552396|E1|Reported Event|0.0003 mg/kg|3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.
431054|NCT00552409|B3|Baseline|Total|Total of all reporting groups
431055|NCT00552409|B2|Baseline|Placebo|One softgel daily for one year
431056|NCT00552409|B1|Baseline|Cholecalciferol|2000 IU by mouth daily for one year
431057|NCT00552409|P2|Participant Flow|Placebo|One softgel daily for one year
431058|NCT00552409|P1|Participant Flow|Cholecalciferol|2000 IU by mouth daily for one year
431060|NCT00552409|O1|Outcome|Cholecalciferol|2000 IU by mouth daily for one year
431061|NCT00552409|E2|Reported Event|Placebo|One softgel daily for one year
431062|NCT00552409|E1|Reported Event|Cholecalciferol|2000 IU by mouth daily for one year
431063|NCT00552422|B1|Baseline|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.
domperidone: 10mg orally four times per day"
431064|NCT00552422|P1|Participant Flow|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.
domperidone: 10mg orally four times per day"
431065|NCT00552422|O1|Outcome|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.
domperidone: 10mg orally four times per day"
431066|NCT00552422|E1|Reported Event|Domperidone|Participants ranged from 18-65 years of age. Gender composition was 60$% female and 40% male.
431067|NCT00552448|B3|Baseline|Total|Total of all reporting groups
431068|NCT00552448|B2|Baseline|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
431069|NCT00552448|B1|Baseline|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
431070|NCT00552448|P2|Participant Flow|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
431071|NCT00552448|P1|Participant Flow|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
431072|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
431073|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
431074|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
431075|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
431076|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
431077|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
431078|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
431079|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
431080|NCT00552448|E2|Reported Event|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
431081|NCT00552448|E1|Reported Event|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
431082|NCT00552513|B3|Baseline|Total|Total of all reporting groups
431083|NCT00552513|B2|Baseline|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
431084|NCT00552513|B1|Baseline|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
431085|NCT00552513|P2|Participant Flow|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
431086|NCT00552513|P1|Participant Flow|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
431087|NCT00552513|O2|Outcome|Delayed Intervention|
431088|NCT00552513|O1|Outcome|Early Intervention|
431089|NCT00552513|O2|Outcome|Delayed Intervention|
431090|NCT00552513|O1|Outcome|Early Intervention|
431091|NCT00552513|O2|Outcome|Delayed Intervention|Coronary angiography to be performed after a minimum delay of 36 hours after randomization
431092|NCT00552513|O1|Outcome|Early Intervention|Coronary angiography to be performed as rapidly as possible and within 24 hours after randomization
431093|NCT00552513|E2|Reported Event|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
431094|NCT00552513|E1|Reported Event|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
431095|NCT00552578|B3|Baseline|Total|Total of all reporting groups
431096|NCT00552578|B2|Baseline|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
431097|NCT00552578|B1|Baseline|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
431098|NCT00552578|P2|Participant Flow|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
431099|NCT00552578|P1|Participant Flow|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
431100|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
431101|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
431102|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
431103|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
431104|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
431105|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
431106|NCT00552578|E2|Reported Event|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
431107|NCT00552578|E1|Reported Event|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
431108|NCT00552669|B3|Baseline|Total|Total of all reporting groups
431109|NCT00552669|B2|Baseline|Drug Eluting Stents|Any Drug Eluting Stents
431110|NCT00552669|B1|Baseline|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
431111|NCT00552669|P2|Participant Flow|Drug Eluting Stents|Any Drug Eluting Stents
431112|NCT00552669|P1|Participant Flow|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
431113|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
431114|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
431115|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
431116|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
431117|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
431118|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
431119|NCT00552669|E2|Reported Event|Drug Eluting Stents|Any Drug Eluting Stents
431120|NCT00552669|E1|Reported Event|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
431121|NCT00552695|B3|Baseline|Total|Total of all reporting groups
431122|NCT00552695|B2|Baseline|Control Patch|Warm patch with no active substances
431123|NCT00552695|B1|Baseline|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
431124|NCT00552695|P2|Participant Flow|Control Patch|Warm patch with no active substances
431125|NCT00552695|P1|Participant Flow|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
431126|NCT00552695|O2|Outcome|Control Patch|Warm patch with no active substances
431127|NCT00552695|O1|Outcome|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
431128|NCT00552695|O2|Outcome|Control Patch|Warm patch with no active substances
431129|NCT00552695|O1|Outcome|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
431130|NCT00552695|E2|Reported Event|Control Patch|Warm patch with no active substances
431131|NCT00552695|E1|Reported Event|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
431132|NCT00552760|B3|Baseline|Total|Total of all reporting groups
431133|NCT00552760|B2|Baseline|Placebo|one tablet at bedtime for up to 6 months
431134|NCT00552760|B1|Baseline|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
431135|NCT00552760|P2|Participant Flow|Placebo|one tablet at bedtime for up to 6 months
431136|NCT00552760|P1|Participant Flow|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
431137|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
431138|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
431139|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
431140|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
431141|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
431142|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
431143|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
431144|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
431145|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
431146|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
431147|NCT00552760|E2|Reported Event|Placebo|one tablet at bedtime for up to 6 months
431148|NCT00552760|E1|Reported Event|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
431149|NCT00552786|B3|Baseline|Total|Total of all reporting groups
431150|NCT00552786|B2|Baseline|Placebo First, Then N-acetylcysteine (NAC)|Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).
431151|NCT00552786|B1|Baseline|N-acetylcysteine (NAC) First, Then Placebo|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
431152|NCT00552786|P2|Participant Flow|Placebo First, Then N-acetylcysteine (NAC)|Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).
431153|NCT00552786|P1|Participant Flow|N-acetylcysteine (NAC) First, Then Placebo|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
431154|NCT00552786|O2|Outcome|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
431155|NCT00552786|O1|Outcome|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
431156|NCT00552786|O2|Outcome|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
431157|NCT00552786|O1|Outcome|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
431158|NCT00552786|E2|Reported Event|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
431159|NCT00552786|E1|Reported Event|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
431160|NCT00552812|B1|Baseline|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
431161|NCT00552812|P1|Participant Flow|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
431162|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
431163|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
431164|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
431165|NCT00552812|E1|Reported Event|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
431166|NCT00553098|B1|Baseline|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
431167|NCT00553098|P1|Participant Flow|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
431168|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
431169|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
431210|NCT00553267|P2|Participant Flow|Telmisartan 40mg and Amlodipine 10mg|
431211|NCT00553267|P1|Participant Flow|Amlodipine 10mg|
431170|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
431171|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
431172|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic Ste"
431173|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic"
431174|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
431175|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic S"
431176|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic S"
431212|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
431213|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
431214|NCT00553267|O1|Outcome|Amlodipine 10mg|
431215|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
431216|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
431177|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
431178|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
431179|NCT00553098|E1|Reported Event|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV
Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
431180|NCT00553150|B3|Baseline|Total|Total of all reporting groups
431181|NCT00553150|B2|Baseline|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431182|NCT00553150|B1|Baseline|Phase I|Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431183|NCT00553150|P4|Participant Flow|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431184|NCT00553150|P3|Participant Flow|Phase 1: Cohort/Dose Level 3 (70 mg RAD001)|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431185|NCT00553150|P2|Participant Flow|Phase I: Cohort/Dose Level 2 (50 mg RAD001)|Cycle 1: Everolimus 50 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 50 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431186|NCT00553150|P1|Participant Flow|Phase I: Cohort/Dose Level 1 (30 mg RAD001)|Cycle 1: Everolimus 30 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 30 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431217|NCT00553267|O1|Outcome|Amlodipine 10mg|
431218|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
431219|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
431220|NCT00553267|O1|Outcome|Amlodipine 10mg|
431221|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
431222|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
431187|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431188|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431189|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431190|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431191|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431192|NCT00553150|O3|Outcome|Phase I: Dose Level 2|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431193|NCT00553150|O2|Outcome|Phase I: Dose Level 1|Cycle 1: Everolimus 50 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 50 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431194|NCT00553150|O1|Outcome|Phase I: Dose Level 0|Cycle 1: Everolimus 30 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 30 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431195|NCT00553150|E2|Reported Event|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431196|NCT00553150|E1|Reported Event|Phase I|Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
431197|NCT00553202|B1|Baseline|Treatment (Chemotherapy and Allogeneic SCT)|All Patients
431198|NCT00553202|P1|Participant Flow|Treatment (Chemotherapy and Allogeneic SCT)|All patients
431199|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All patients
431200|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All patients
431201|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All patients
431202|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All Patients
431203|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All Patients
431204|NCT00553202|E1|Reported Event|Group 1|All patients
431205|NCT00553267|B4|Baseline|Total|Total of all reporting groups
431206|NCT00553267|B3|Baseline|Telmisartan 80mg and Amlodipine 10mg|
431207|NCT00553267|B2|Baseline|Telmisartan 40mg and Amlodipine 10mg|
431208|NCT00553267|B1|Baseline|Amlodipine 10mg|
431209|NCT00553267|P3|Participant Flow|Telmisartan 80mg and Amlodipine 10mg|
431245|NCT00553280|B1|Baseline|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
431246|NCT00553280|P1|Participant Flow|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
431247|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
431248|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
431249|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
431250|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
431251|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
431252|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
431253|NCT00553280|E1|Reported Event|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
431254|NCT00553319|B4|Baseline|Total|Total of all reporting groups
431255|NCT00553319|B3|Baseline|Adderall-XR 80 mg|"Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day"
431256|NCT00553319|B2|Baseline|Adderall-XR 60 mg|"Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day"
431257|NCT00553319|B1|Baseline|Placebo|"Placebo
Placebo: Placebo group"
431258|NCT00553319|P3|Participant Flow|Adderall-XR 80 mg|"Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day"
431259|NCT00553319|P2|Participant Flow|Adderall-XR 60 mg|"Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day"
431260|NCT00553319|P1|Participant Flow|Placebo|"Placebo
Placebo: Placebo group"
431261|NCT00553319|O3|Outcome|Adderall-XR 80 mg|"Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day"
431262|NCT00553319|O2|Outcome|Adderall-XR 60 mg|"Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day"
431263|NCT00553319|O1|Outcome|Placebo|"Placebo
Placebo: Placebo group"
431264|NCT00553319|O3|Outcome|Adderall-XR 80 mg|"Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day"
431265|NCT00553319|O2|Outcome|Adderall-XR 60 mg|"Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day"
431267|NCT00553319|E3|Reported Event|Adderall-XR 80 mg|"Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day"
431268|NCT00553319|E2|Reported Event|Adderall-XR 60 mg|"Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day"
431269|NCT00553319|E1|Reported Event|Placebo|"Placebo
Placebo: Placebo group"
431270|NCT00553332|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
selumetinib: Given orally
laboratory biomarker analysis: Correlative studies"
431271|NCT00553332|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
selumetinib: Given orally
laboratory biomarker analysis: Correlative studies"
431272|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
selumetinib: Given orally
laboratory biomarker analysis: Correlative studies"
431273|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
selumetinib: Given orally
laboratory biomarker analysis: Correlative studies"
431274|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
selumetinib: Given orally
laboratory biomarker analysis: Correlative studies"
431275|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
selumetinib: Given orally
laboratory biomarker analysis: Correlative studies"
431276|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
selumetinib: Given orally
laboratory biomarker analysis: Correlative studies"
431277|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
selumetinib: Given orally
laboratory biomarker analysis: Correlative studies"
431278|NCT00553332|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
selumetinib: Given orally
laboratory biomarker analysis: Correlative studies"
431279|NCT00553358|B4|Baseline|Total|Total of all reporting groups
431280|NCT00553358|B3|Baseline|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431281|NCT00553358|B2|Baseline|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431282|NCT00553358|B1|Baseline|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenously (IV) for an additional 12 weeks
431283|NCT00553358|P3|Participant Flow|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431284|NCT00553358|P2|Participant Flow|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431285|NCT00553358|P1|Participant Flow|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenously (IV) for an additional 12 weeks
431286|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431287|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431288|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
431289|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431290|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431291|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
431292|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431293|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431294|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
431356|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431295|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431296|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431297|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
431298|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431299|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431300|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
431301|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431302|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431303|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
431304|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431305|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431306|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
431307|NCT00553358|E3|Reported Event|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431308|NCT00553358|E2|Reported Event|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
431309|NCT00553358|E1|Reported Event|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
431310|NCT00553436|B1|Baseline|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
431311|NCT00553436|P1|Participant Flow|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
431312|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
431313|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
431314|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
431315|NCT00553436|E1|Reported Event|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
431316|NCT00553462|B1|Baseline|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
431317|NCT00553462|P1|Participant Flow|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
431318|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
431319|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
431357|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431358|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431320|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
431321|NCT00553462|E1|Reported Event|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
431322|NCT00553475|B4|Baseline|Total|Total of all reporting groups
431323|NCT00553475|B3|Baseline|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431324|NCT00553475|B2|Baseline|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431325|NCT00553475|B1|Baseline|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431326|NCT00553475|P3|Participant Flow|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431327|NCT00553475|P2|Participant Flow|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431328|NCT00553475|P1|Participant Flow|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431329|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431330|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431331|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431332|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431333|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431334|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431335|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431336|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431337|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431338|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431339|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431340|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431341|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431342|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431343|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431344|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431345|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431346|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431347|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431348|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431349|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431350|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431351|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431352|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431353|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431354|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431355|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
439656|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
431359|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431360|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431361|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431362|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431363|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431364|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431365|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431366|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431367|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431368|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431369|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431370|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431371|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431372|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431373|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431374|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431375|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431376|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431377|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431378|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431379|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431380|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431381|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431382|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431383|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431384|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431385|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431386|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431387|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431388|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431389|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431390|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431391|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431392|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431393|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431394|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431395|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431396|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431397|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431398|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431399|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431400|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431401|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431402|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431403|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431404|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431405|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431406|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431407|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431408|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431409|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431410|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431411|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431412|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431413|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431414|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431415|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431416|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431417|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431418|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431419|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431420|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431421|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431422|NCT00553475|O3|Outcome|Expected Exposure Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr in the pregabalin 300 and 600 mg/day groups received pregabalin 300 mg/day and subjects with normal CLcr in the pregabalin 600 mg/day group received pregabalin 600 mg/day for 12 weeks.
431423|NCT00553475|O2|Outcome|Expected Exposure Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with normal CLcr in the pregabalin 300 mg/day group received pregabalin 300 mg/day for 12 weeks.
431424|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431425|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431426|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431427|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431428|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431429|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431430|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431431|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431432|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431433|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431434|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431614|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
431435|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431436|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431437|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431438|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431439|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431440|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431441|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431442|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431443|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431444|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431445|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431446|NCT00553475|E3|Reported Event|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
431447|NCT00553475|E2|Reported Event|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
431448|NCT00553475|E1|Reported Event|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
431449|NCT00553501|B1|Baseline|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):
Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22
Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
431450|NCT00553501|P1|Participant Flow|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):
Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22
Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
431451|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):
Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22
Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
431452|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):
Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22
Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
431453|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):
Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22
Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
431454|NCT00553501|E1|Reported Event|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):
Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22
Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
431455|NCT00553514|B6|Baseline|Total|Total of all reporting groups
431456|NCT00553514|B5|Baseline|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431457|NCT00553514|B4|Baseline|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431458|NCT00553514|B3|Baseline|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431459|NCT00553514|B2|Baseline|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431509|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
439657|NCT00577135|O4|Outcome|High Intensification|
431460|NCT00553514|B1|Baseline|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431461|NCT00553514|P5|Participant Flow|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431462|NCT00553514|P4|Participant Flow|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431463|NCT00553514|P3|Participant Flow|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431464|NCT00553514|P2|Participant Flow|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431465|NCT00553514|P1|Participant Flow|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431466|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431467|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431468|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431469|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431470|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
439658|NCT00577135|O3|Outcome|Low Intensification|
431471|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431472|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431473|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431474|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431475|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431476|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431477|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431478|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431479|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431480|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431481|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431510|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431547|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
431482|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431483|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431484|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431485|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431486|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431487|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431488|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431489|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431490|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431491|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431492|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431511|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
439659|NCT00577135|O2|Outcome|Continuous Infusion|
431493|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431494|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431495|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431496|NCT00553514|E5|Reported Event|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431497|NCT00553514|E4|Reported Event|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431498|NCT00553514|E3|Reported Event|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431499|NCT00553514|E2|Reported Event|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431500|NCT00553514|E1|Reported Event|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
431501|NCT00553605|B3|Baseline|Total|Total of all reporting groups
431502|NCT00553605|B2|Baseline|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431503|NCT00553605|B1|Baseline|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
431504|NCT00553605|P2|Participant Flow|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431505|NCT00553605|P1|Participant Flow|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
431506|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431507|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
431508|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431512|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431513|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
431514|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431515|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
431516|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431517|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
431518|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431519|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
431520|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431521|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
431522|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431523|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
431524|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431525|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
431526|NCT00553605|E2|Reported Event|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
431527|NCT00553605|E1|Reported Event|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
431528|NCT00561977|B4|Baseline|Total|Total of all reporting groups
431529|NCT00561977|B3|Baseline|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
431530|NCT00561977|B2|Baseline|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
431531|NCT00561977|B1|Baseline|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
431532|NCT00561977|P3|Participant Flow|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
431533|NCT00561977|P2|Participant Flow|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
431534|NCT00561977|P1|Participant Flow|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
431535|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
431536|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
431537|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
431538|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
431539|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
431540|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
431541|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
431542|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
431543|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
431544|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
431545|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
431546|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
439660|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
431548|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
431549|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
431550|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
431551|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
431552|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
431553|NCT00561977|E3|Reported Event|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
431554|NCT00561977|E2|Reported Event|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
431555|NCT00561977|E1|Reported Event|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
431556|NCT00562094|B1|Baseline|Pantoprazole|All patients enrolled
431557|NCT00562094|P1|Participant Flow|Pantoprazole|All patients enrolled
431558|NCT00562094|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
431559|NCT00562094|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
431560|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
431561|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
431562|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
431563|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
431564|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values ('as observed')
431565|NCT00562094|O2|Outcome|Pantoprazole / End of Therapy|All patients with valid values ('as observed')
431566|NCT00562094|O1|Outcome|Pantoprazole / Start of Therapy|All patients with valid values ('as observed')
431567|NCT00562094|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
431568|NCT00562120|B1|Baseline|Entire Study Population|All participants randomized to any treatment (PF-03654746 10 mg capsule first, PF-03654746 1 mg capsule first, Allegra-D tablet-in-capsule first and placebo first).
431569|NCT00562120|P4|Participant Flow|Placebo, Allegra-D, PF-03654746 10 mg, PF-03654746 1 mg|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
431570|NCT00562120|P3|Participant Flow|Allegra-D, PF-03654746 1 mg, Placebo, PF-03654746 10 mg|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
431571|NCT00562120|P2|Participant Flow|PF-03654746 1 mg, PF-03654746 10 mg, Allegra-D, Placebo|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule and Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
431572|NCT00562120|P1|Participant Flow|PF-03654746 10 mg, Placebo, PF-03654746 1 mg, Allegra-D|PF-03654746 10 milligram (mg) capsule and Allegra (fexofenadine 60 mg) tablet-in-capsule along with placebo matched to Allegra-D (fexofenadine 60 mg in combination with pseudoephedrine 120 mg) tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
431573|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431574|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431575|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431576|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431577|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431578|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431579|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431580|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431581|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431582|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431583|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431584|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431585|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431586|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431587|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431588|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431589|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431590|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431591|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431592|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431593|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431594|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431595|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431596|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431597|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431598|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431599|NCT00562120|E4|Reported Event|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431600|NCT00562120|E3|Reported Event|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431601|NCT00562120|E2|Reported Event|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431602|NCT00562120|E1|Reported Event|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
431603|NCT00562159|B3|Baseline|Total|Total of all reporting groups
431604|NCT00562159|B2|Baseline|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
431605|NCT00562159|B1|Baseline|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
431606|NCT00562159|P2|Participant Flow|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
431607|NCT00562159|P1|Participant Flow|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
431608|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
431609|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
431610|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
431611|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
431612|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
431613|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
433162|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
431615|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
431616|NCT00562159|E2|Reported Event|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
431617|NCT00562159|E1|Reported Event|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
431618|NCT00562302|B3|Baseline|Total|Total of all reporting groups
431619|NCT00562302|B2|Baseline|Control Group|Control group with no intervention
431620|NCT00562302|B1|Baseline|Bio-Seal Group|Bio-Seal Plug Implanted
431621|NCT00562302|P2|Participant Flow|Control Group|Control group with no intervention
431622|NCT00562302|P1|Participant Flow|Bio-Seal Group|Bio-Seal Plug Implanted
431623|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
431624|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
431625|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
431626|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
431627|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
431628|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
431629|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
431630|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
431631|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
431632|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
431633|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
431634|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
431635|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
431636|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
431637|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
431638|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
431639|NCT00562302|E2|Reported Event|Control Group|Control group with no intervention
431640|NCT00562302|E1|Reported Event|Bio-Seal Group|Bio-Seal Plug Implanted
431641|NCT00562861|B3|Baseline|Total|Total of all reporting groups
431642|NCT00562861|B2|Baseline|Mood Stabilizer Plus Placebo|Placebo plus mood stabilizer: subjects receive placebo, added to standard mood stabilizers
431643|NCT00562861|B1|Baseline|Mood Stabilizer Plus Citalopram|citalopram + mood stabilizer: Subjects receive the active drug, added to standard mood stabilizers.
431644|NCT00562861|P2|Participant Flow|Mood Stabilizer Plus Placebo|Mood stabilizer alone will be the treatment, with placebo used instead of double-blind citalopram.
431645|NCT00562861|P1|Participant Flow|Mood Stabilizer Plus Citalopram|citalopram + mood stabilizer: Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d.
431646|NCT00562861|O2|Outcome|Placebo|Mood stabilizers given as part of standard treatment plus double-blind placebo
431647|NCT00562861|O1|Outcome|Citalopram|Mood stabilizers given as part of standard treatment plus double-blind citalopram
431648|NCT00562861|E2|Reported Event|Placebo|Mood stabilizers given as part of standard treatment plus double-blind placebo
431649|NCT00562861|E1|Reported Event|Citalopram|Mood stabilizers given as part of standard treatment plus double-blind citalopram
431650|NCT00563290|B3|Baseline|Total|Total of all reporting groups
431651|NCT00563290|B2|Baseline|Arm II Dastinib|Patients receive oral dasatinib 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
431652|NCT00563290|B1|Baseline|Arm I Dasatinib|Patients receive oral dasatinib 100 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
431653|NCT00563290|P2|Participant Flow|Arm II Dasatinib|Patients receive 70 mg dasatinib PO BID on days 1-28
431654|NCT00563290|P1|Participant Flow|Arm I Dasatinib|Patients receive 100 mg orally twice a day.
431655|NCT00563290|O1|Outcome|Dasatinib|Patients receive 100 mg orally twice a day. Due to a dosing update the dose was decreased to 70 mg orally twice a day.
431656|NCT00563290|O1|Outcome|Dasatinib|Patients receive 100 mg orally twice a day. Due to a dosing update the dose was decreased to 70 mg orally twice a day.
431657|NCT00563290|O1|Outcome|Arm I and Arm II|"For Arm I patients receive Dasatinib100 mg orally twice a day.
For Arm II patients receive Dasatinib 70 mg orally twice a day."
431658|NCT00563290|O2|Outcome|Arm II: Dasatinib|Patients receive 70 mg orally twice a day.
431659|NCT00563290|O1|Outcome|Arm I: Dasatinib|Patients receive 100 mg orally twice a day.
431660|NCT00563290|E2|Reported Event|Dasatinib 70 mg|Patients receive the initial dose of 70 mg orally twice a day. Dose was reduced to 70 mg orally based on toxicity.
431661|NCT00563290|E1|Reported Event|Dasatinib 100 mg|Patients receive the initial dose of 100 mg orally twice a day.
431662|NCT00563316|B1|Baseline|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
431663|NCT00563316|P1|Participant Flow|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
431664|NCT00563316|O5|Outcome|Treatment Phase 4|All Other – 72 hours after administration of irinotecan in Cycle 2 until end of study.
431665|NCT00563316|O4|Outcome|Treatment Phase 3|Cycle 2 Irinotecan and Panitumumab – After irinotecan administration until 72 hours after administration.
431666|NCT00563316|O3|Outcome|Treatment Phase 2|Cycle 1 Irinotecan and Panitumumab – After first panitumumab administration until the start of Cycle 2.
431667|NCT00563316|O2|Outcome|Treatment Phase 1|Cycle 1 Irinotecan – After irinotecan administration, but before panitumumab administration.
431668|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
432050|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
431669|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
431670|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
431671|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
431672|NCT00563316|E1|Reported Event|Panitumumab With Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
431673|NCT00563368|B8|Baseline|Total|Total of all reporting groups
431674|NCT00563368|B7|Baseline|VI-0521 Top|15 mg/92 mg phentermine/topiramate
431675|NCT00563368|B6|Baseline|TPM 92 mg|92 mg topiramate
431676|NCT00563368|B5|Baseline|PHEN 15 mg|15 mg phentermine
431677|NCT00563368|B4|Baseline|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
431678|NCT00563368|B3|Baseline|TPM 46 mg|46 mg topiramate
431679|NCT00563368|B2|Baseline|PHEN 7.5 mg|7.5 mg phentermine
431680|NCT00563368|B1|Baseline|Placebo|Placebo
431681|NCT00563368|P7|Participant Flow|VI-0521 Top|15 mg/92 mg phentermine/topiramate
431682|NCT00563368|P6|Participant Flow|TPM 92 mg|92 mg topiramate
431683|NCT00563368|P5|Participant Flow|PHEN 15 mg|15 mg phentermine
431684|NCT00563368|P4|Participant Flow|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
431685|NCT00563368|P3|Participant Flow|TPM 46 mg|46 mg topiramate
431686|NCT00563368|P2|Participant Flow|PHEN 7.5 mg|7.5 mg phentermine
431687|NCT00563368|P1|Participant Flow|Placebo|Placebo
431688|NCT00563368|O7|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
431689|NCT00563368|O6|Outcome|TPM 92 mg|92 mg topiramate
431690|NCT00563368|O5|Outcome|PHEN 15 mg|15 mg phentermine
431691|NCT00563368|O4|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
431692|NCT00563368|O3|Outcome|TPM 46 mg|46 mg topiramate
431693|NCT00563368|O2|Outcome|PHEN 7.5 mg|7.5 mg phentermine
431694|NCT00563368|O1|Outcome|Placebo|Placebo
431695|NCT00563368|O7|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
431696|NCT00563368|O6|Outcome|TPM 92 mg|92 mg topiramate
431697|NCT00563368|O5|Outcome|PHEN 15 mg|15 mg phentermine
431698|NCT00563368|O4|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
431699|NCT00563368|O3|Outcome|TPM 46 mg|46 mg topiramate
431700|NCT00563368|O2|Outcome|PHEN 7.5 mg|7.5 mg phentermine
431701|NCT00563368|O1|Outcome|Placebo|Placebo
431702|NCT00563368|E7|Reported Event|VI-0521 Top|15 mg/92 mg phentermine/topiramate
431703|NCT00563368|E6|Reported Event|TPM 92 mg|92 mg topiramate
431704|NCT00563368|E5|Reported Event|PHEN 15 mg|15 mg phentermine
431705|NCT00563368|E4|Reported Event|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
431706|NCT00563368|E3|Reported Event|TPM 46 mg|46 mg topiramate
431707|NCT00563368|E2|Reported Event|PHEN 7.5 mg|7.5 mg phentermine
431708|NCT00563368|E1|Reported Event|Placebo|Placebo
431709|NCT00563381|B3|Baseline|Total|Total of all reporting groups
431710|NCT00563381|B2|Baseline|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431711|NCT00563381|B1|Baseline|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431712|NCT00563381|P2|Participant Flow|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431713|NCT00563381|P1|Participant Flow|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431714|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431715|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431716|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431717|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431718|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431719|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431720|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431721|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431722|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431723|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431724|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431725|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431726|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431727|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431728|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431729|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431730|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431731|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431732|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431733|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431734|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431735|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431736|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431737|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431738|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431739|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431740|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431741|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431742|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431743|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431744|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431745|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431746|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431747|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431748|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431749|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431750|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431751|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431752|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431753|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431754|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431755|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431756|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431757|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431758|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431759|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431760|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431761|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431762|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431763|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431764|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431765|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431766|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431767|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431768|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431769|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431770|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431771|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431772|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431773|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431774|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431775|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431776|NCT00563381|E2|Reported Event|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
431777|NCT00563381|E1|Reported Event|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
431778|NCT00563576|B3|Baseline|Total|Total of all reporting groups
431779|NCT00563576|B2|Baseline|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
431780|NCT00563576|B1|Baseline|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
431781|NCT00563576|P2|Participant Flow|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
431782|NCT00563576|P1|Participant Flow|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
431783|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
431784|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
431785|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
431786|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
431787|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
431788|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
431789|NCT00563576|E2|Reported Event|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
431790|NCT00563576|E1|Reported Event|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
431791|NCT00563706|B10|Baseline|Total|Total of all reporting groups
431792|NCT00563706|B9|Baseline|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431793|NCT00563706|B8|Baseline|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431794|NCT00563706|B7|Baseline|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431795|NCT00563706|B6|Baseline|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431796|NCT00563706|B5|Baseline|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431797|NCT00563706|B4|Baseline|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431798|NCT00563706|B3|Baseline|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431799|NCT00563706|B2|Baseline|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431800|NCT00563706|B1|Baseline|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431801|NCT00563706|P9|Participant Flow|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431802|NCT00563706|P8|Participant Flow|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431803|NCT00563706|P7|Participant Flow|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431804|NCT00563706|P6|Participant Flow|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431805|NCT00563706|P5|Participant Flow|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431806|NCT00563706|P4|Participant Flow|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431807|NCT00563706|P3|Participant Flow|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431808|NCT00563706|P2|Participant Flow|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431809|NCT00563706|P1|Participant Flow|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431810|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431811|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431812|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431813|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431814|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431899|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431815|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431816|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431817|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431818|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431819|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431820|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431821|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431822|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431823|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431824|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431825|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431826|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431827|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431828|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431829|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431830|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431831|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431832|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431833|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431834|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431835|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431836|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431837|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431838|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431839|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431840|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431841|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431842|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431843|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431844|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431845|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431846|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431847|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431848|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431849|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431850|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431851|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431852|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431853|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431854|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431855|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431856|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431857|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431858|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431859|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431860|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431861|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431862|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431863|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431864|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431865|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431866|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431867|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431868|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431869|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431870|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431871|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431872|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431873|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431874|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431875|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431876|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431877|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431878|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431879|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431880|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431881|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431882|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431883|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431884|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431885|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431886|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431887|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431888|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431889|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431890|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431891|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431892|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431893|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431894|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431895|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431896|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431897|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431898|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
432075|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
431900|NCT00563706|E9|Reported Event|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
431901|NCT00563706|E8|Reported Event|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431902|NCT00563706|E7|Reported Event|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
431903|NCT00563706|E6|Reported Event|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431904|NCT00563706|E5|Reported Event|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
431905|NCT00563706|E4|Reported Event|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431906|NCT00563706|E3|Reported Event|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431907|NCT00563706|E2|Reported Event|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431908|NCT00563706|E1|Reported Event|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
431909|NCT00563797|B3|Baseline|Total|Total of all reporting groups
431910|NCT00563797|B2|Baseline|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill"
431911|NCT00563797|B1|Baseline|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks"
431912|NCT00563797|P2|Participant Flow|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill"
431913|NCT00563797|P1|Participant Flow|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks"
431914|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill"
431915|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks"
431916|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill"
431917|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks"
431918|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill"
431919|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks"
431920|NCT00563797|O2|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks"
431921|NCT00563797|O1|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill"
432232|NCT00556894|O1|Outcome|CF101 0.1mg|
431922|NCT00563797|E2|Reported Event|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to themedication capsules.
Placebo: Placebo pill"
431923|NCT00563797|E1|Reported Event|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks"
431924|NCT00564265|B1|Baseline|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
431925|NCT00564265|P1|Participant Flow|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
431926|NCT00564265|O1|Outcome|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
431927|NCT00564265|E1|Reported Event|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
431928|NCT00564278|B3|Baseline|Total|Total of all reporting groups
431929|NCT00564278|B2|Baseline|Motivational Pharmacotherapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 44.1 with SD=12.3.
431930|NCT00564278|B1|Baseline|Standard Medication Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 43.4 with SD=13.2.
431931|NCT00564278|P2|Participant Flow|Motivational Antidepressant Therapy|As per study criteria, the N=98 sample is our sample for data analysis. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 44.1 (SD = 12.3).
431932|NCT00564278|P1|Participant Flow|Standard Antidepressant Therapy|As per study criteria, the N=97 sample is our sample for data analysis. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 43.41 (SD = 13.2).
431933|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
431934|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
431935|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
431936|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
431937|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
431938|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
431939|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
431940|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
431941|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
431942|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
431943|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
431944|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
432003|NCT00564629|B2|Baseline|IV APAP 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g of acetaminophen in 100 ml of intravenous solution and oral placebo as the study treatment
431945|NCT00564278|E2|Reported Event|Motivational Antidepressant Therapy|Participants will receive motivational antidepressant therapy. Motivational antidepressant therapy (MADT): The same medication treatment for depression will be offered as in the SADT arm and supplemented with techniques from motivational interviewing.
431946|NCT00564278|E1|Reported Event|Standard Antidepressant Therapy|Participants will receive standard antidepressant therapy. Standard antidepressant therapy (SADT): Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
431947|NCT00564447|B9|Baseline|Total|Total of all reporting groups
431948|NCT00564447|B8|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
431949|NCT00564447|B7|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
431950|NCT00564447|B6|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
431951|NCT00564447|B5|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
431952|NCT00564447|B4|Baseline|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
431953|NCT00564447|B3|Baseline|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
431954|NCT00564447|B2|Baseline|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
431955|NCT00564447|B1|Baseline|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
431956|NCT00564447|P8|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
431957|NCT00564447|P7|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
431958|NCT00564447|P6|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
431959|NCT00564447|P5|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
431960|NCT00564447|P4|Participant Flow|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
431961|NCT00564447|P3|Participant Flow|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
431962|NCT00564447|P2|Participant Flow|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
431963|NCT00564447|P1|Participant Flow|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
431964|NCT00564447|O8|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
431965|NCT00564447|O7|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
431966|NCT00564447|O6|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
431967|NCT00564447|O5|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
431968|NCT00564447|O4|Outcome|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
431969|NCT00564447|O3|Outcome|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
431970|NCT00564447|O2|Outcome|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
431971|NCT00564447|O1|Outcome|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
431972|NCT00564447|E8|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
431973|NCT00564447|E7|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
431974|NCT00564447|E6|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
431975|NCT00564447|E5|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
431976|NCT00564447|E4|Reported Event|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
431977|NCT00564447|E3|Reported Event|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
431978|NCT00564447|E2|Reported Event|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
431979|NCT00564447|E1|Reported Event|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
431980|NCT00564486|B4|Baseline|Total|Total of all reporting groups
431981|NCT00564486|B3|Baseline|IV Acetaminophen 650 mg|All subjects randomized to receive IV Acetaminophen 650 mg
431982|NCT00564486|B2|Baseline|IV Acetaminophen 1 gm|All subjects randomized to receive IV Acetaminophen 1 gm
431983|NCT00564486|B1|Baseline|IV Placebo|All subjects randomized to receive IV Placebo 100 ml and IV placebo 65 ml groups combined
431984|NCT00564486|P4|Participant Flow|IV Placebo (65 ml)|IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
431985|NCT00564486|P3|Participant Flow|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
431986|NCT00564486|P2|Participant Flow|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
431987|NCT00564486|P1|Participant Flow|Intravenous (IV) Placebo (100 ml)|IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
431988|NCT00564486|O3|Outcome|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg every 4 hours for 24 hours (6 doses total)
431989|NCT00564486|O2|Outcome|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm every 6 hours for 24 hours (4 doses total)
431990|NCT00564486|O1|Outcome|IV Placebo|IV Placebo 100 ml and IV placebo 65 ml groups combined
431991|NCT00564486|O3|Outcome|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg every 4 hours for 24 hours
431992|NCT00564486|O2|Outcome|IV Acetaminophen 1000 mg|IV Acetaminophen 1000 mg every 6 hours for 24 hours
431993|NCT00564486|O1|Outcome|IV Placebo|IV Placebo 100 ml and IV placebo 65 ml groups combined
431994|NCT00564486|O2|Outcome|IV Acetaminophen 650 mg|mITT - IV Acetaminophen 650 mg
431995|NCT00564486|O1|Outcome|IV Placebo|mITT - IV Placebo 100 ml and IV placebo 65 ml groups combined
431996|NCT00564486|O2|Outcome|IV Acetaminophen 1 gm|mITT - IV Acetaminophen 1 gm
431997|NCT00564486|O1|Outcome|IV Placebo|mITT - IV Placebo 100 ml and IV placebo 65 ml groups combined
431998|NCT00564486|E4|Reported Event|IV Placebo (65 ml)|IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
431999|NCT00564486|E3|Reported Event|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
432000|NCT00564486|E2|Reported Event|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
432001|NCT00564486|E1|Reported Event|Intravenous (IV) Placebo (100 ml)|IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
432002|NCT00564629|B3|Baseline|Total|Total of all reporting groups
432004|NCT00564629|B1|Baseline|PO APAP 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen and 100 ml of intravenous placebo solution as the study treatment
432005|NCT00564629|P2|Participant Flow|Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g /100 ml of intravenous acetaminophen solution as the study treatment
432006|NCT00564629|P1|Participant Flow|Oral Acetaminophen (PO APAP) 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen as the study treatment
432007|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
432008|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
432009|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
432010|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
432011|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
432012|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
432013|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
432014|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
432015|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
432016|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
432017|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
432018|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
432019|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
432020|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
432021|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
432022|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
432023|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
432024|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
432025|NCT00564629|E2|Reported Event|Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g /100 ml of intravenous acetaminophen solution as the study treatment
432026|NCT00564629|E1|Reported Event|Oral Acetaminophen (PO APAP) 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen as the study treatment
432027|NCT00564681|B5|Baseline|Total|Total of all reporting groups
432028|NCT00564681|B4|Baseline|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
432029|NCT00564681|B3|Baseline|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
432030|NCT00564681|B2|Baseline|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
432031|NCT00564681|B1|Baseline|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
432032|NCT00564681|P4|Participant Flow|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
432033|NCT00564681|P3|Participant Flow|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
432034|NCT00564681|P2|Participant Flow|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
432035|NCT00564681|P1|Participant Flow|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
432036|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
432037|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
432038|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
432039|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
432040|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
432041|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
432042|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
432043|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
432044|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
432045|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
432046|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
432047|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
432048|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
432049|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
432233|NCT00556894|E3|Reported Event|Placebo|Matching Placebo q12 for 12 weeks
432051|NCT00564681|E4|Reported Event|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
432052|NCT00564681|E3|Reported Event|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
432053|NCT00564681|E2|Reported Event|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
432054|NCT00564681|E1|Reported Event|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
432055|NCT00564733|B1|Baseline|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.
carboplatin: Given IV
docetaxel: Given IV
gemcitabine hydrochloride: Given IV
paclitaxel: Given IV
computed tomography: Undergo FDG PET/CT
positron emission tomography: Undergo FDG PET/CT
fludeoxyglucose F 18: Given IV
imaging biomarker analysis: Correlative studies"
432056|NCT00564733|P1|Participant Flow|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.
carboplatin: Given IV
docetaxel: Given IV
gemcitabine hydrochloride: Given IV
paclitaxel: Given IV
computed tomography: Undergo FDG PET/CT
positron emission tomography: Undergo FDG PET/CT
fludeoxyglucose F 18: Given IV
imaging biomarker analysis: Correlative studies"
432057|NCT00564733|O1|Outcome|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.
carboplatin: Given IV
docetaxel: Given IV
gemcitabine hydrochloride: Given IV
paclitaxel: Given IV
computed tomography: Undergo FDG PET/CT
positron emission tomography: Undergo FDG PET/CT
fludeoxyglucose F 18: Given IV
imaging biomarker analysis: Correlative studies"
432058|NCT00564733|E1|Reported Event|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.
carboplatin: Given IV
docetaxel: Given IV
gemcitabine hydrochloride: Given IV
paclitaxel: Given IV
computed tomography: Undergo FDG PET/CT
positron emission tomography: Undergo FDG PET/CT
fludeoxyglucose F 18: Given IV
imaging biomarker analysis: Correlative studies"
432059|NCT00564850|B1|Baseline|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432060|NCT00564850|P1|Participant Flow|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432061|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432062|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432063|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432064|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432065|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432066|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432067|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432068|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432069|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432070|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432071|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432072|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432073|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432074|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432076|NCT00564850|E1|Reported Event|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
432077|NCT00564876|B1|Baseline|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
432078|NCT00564876|P1|Participant Flow|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
432079|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
432080|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
432081|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
432082|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
432083|NCT00564876|E1|Reported Event|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
432084|NCT00564889|B1|Baseline|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
432085|NCT00564889|P1|Participant Flow|Len/Cyc/Dex|"Lenalidomide (Len) 15mg daily (days 1-21)
Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15)
Dexamethasone (Dex) 40 mg weekly"
432086|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
432087|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
432088|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
432089|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
432090|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
432091|NCT00564889|E1|Reported Event|Len/Cyc/Dex|Dexamethasone (Dex) 40 mg weekly
432092|NCT00564902|B4|Baseline|Total|Total of all reporting groups
432093|NCT00564902|B3|Baseline|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432094|NCT00564902|B2|Baseline|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432095|NCT00564902|B1|Baseline|Lutein|Lutein 9 mg per day
432096|NCT00564902|P3|Participant Flow|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432097|NCT00564902|P2|Participant Flow|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432098|NCT00564902|P1|Participant Flow|Lutein|Lutein 9 mg per day
432099|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432100|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432101|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
432102|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432103|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432104|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
432105|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432106|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432107|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
432108|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432109|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432110|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
432111|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432112|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432113|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
432114|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432115|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432116|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
432117|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432118|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432119|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
432120|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432121|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432122|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
432123|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432124|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432125|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
432126|NCT00564902|E3|Reported Event|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
432127|NCT00564902|E2|Reported Event|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
432128|NCT00564902|E1|Reported Event|Lutein|Lutein 9 mg per day
432129|NCT00564954|B3|Baseline|Total|Total of all reporting groups
432130|NCT00564954|B2|Baseline|Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)|Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning.
432131|NCT00564954|B1|Baseline|Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo|Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning.
432132|NCT00564954|P2|Participant Flow|Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)|Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning.
432133|NCT00564954|P1|Participant Flow|Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo|Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning.
432134|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
432135|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
432136|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
432137|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
432138|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
432139|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
432140|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
432141|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
432142|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
432143|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
432144|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
432145|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
432146|NCT00564954|E2|Reported Event|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
432147|NCT00564954|E1|Reported Event|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
432148|NCT00565045|B3|Baseline|Total|Total of all reporting groups
432149|NCT00565045|B2|Baseline|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.
Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
Therapy sessions are done without the stimulation system"
432150|NCT00565045|B1|Baseline|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation
Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
Therapy sessions are done with the subject being assisted by the CCFES system."
432151|NCT00565045|P2|Participant Flow|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.
Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
Therapy sessions are done without the stimulation system"
432152|NCT00565045|P1|Participant Flow|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation
Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
Therapy sessions are done with the subject being assisted by the CCFES system."
432153|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.
Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
Therapy sessions are done without the stimulation system"
432154|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation
Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
Therapy sessions are done with the subject being assisted by the CCFES system."
432155|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.
Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
Therapy sessions are done without the stimulation system"
432156|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation
Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
Therapy sessions are done with the subject being assisted by the CCFES system."
432157|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.
Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
Therapy sessions are done without the stimulation system"
432158|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation
Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
Therapy sessions are done with the subject being assisted by the CCFES system."
432159|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.
Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
Therapy sessions are done without the stimulation system"
432160|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation
Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
Therapy sessions are done with the subject being assisted by the CCFES system."
432161|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.
Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
Therapy sessions are done without the stimulation system"
432162|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation
Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
Therapy sessions are done with the subject being assisted by the CCFES system."
432163|NCT00565045|E2|Reported Event|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.
Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
Therapy sessions are done without the stimulation system"
432164|NCT00565045|E1|Reported Event|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation
Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
Therapy sessions are done with the subject being assisted by the CCFES system."
432165|NCT00565058|B3|Baseline|Total|Total of all reporting groups
432166|NCT00565058|B2|Baseline|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
432167|NCT00565058|B1|Baseline|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
432168|NCT00565058|P2|Participant Flow|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
432169|NCT00565058|P1|Participant Flow|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
432170|NCT00565058|O2|Outcome|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
432171|NCT00565058|O1|Outcome|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
432234|NCT00556894|E2|Reported Event|CF101 1mg|CF101 1mg q12 for 12 weeks
432172|NCT00565058|O2|Outcome|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
432173|NCT00565058|O1|Outcome|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
432174|NCT00565058|E2|Reported Event|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
432175|NCT00565058|E1|Reported Event|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
432176|NCT00565084|B1|Baseline|Overall Study|
432177|NCT00565084|P3|Participant Flow|Ibuprofen-Placebo-Placebo|Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
432178|NCT00565084|P2|Participant Flow|Placebo-Ibuprofen-Placebo|First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
432179|NCT00565084|P1|Participant Flow|Placebo-Placebo-Ibuprofen|First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
432180|NCT00565084|O3|Outcome|Placebo 2|Second Single dose placebo
432181|NCT00565084|O2|Outcome|Placebo 1|First Single dose placebo
432182|NCT00565084|O1|Outcome|Ibuprofen|Single dose ibuprofen 800 mg
432183|NCT00565084|E3|Reported Event|Ibuprofen-Placebo-Placebo|Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
432184|NCT00565084|E2|Reported Event|Placebo-Ibuprofen-Placebo|First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
432185|NCT00565084|E1|Reported Event|Placebo-Placebo-Ibuprofen|First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
432186|NCT00565110|B3|Baseline|Total|Total of all reporting groups
432187|NCT00565110|B2|Baseline|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
432188|NCT00565110|B1|Baseline|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
432189|NCT00565110|P2|Participant Flow|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
432190|NCT00565110|P1|Participant Flow|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
432191|NCT00565110|O2|Outcome|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
432192|NCT00565110|O1|Outcome|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
432193|NCT00565110|O2|Outcome|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
432235|NCT00556894|E1|Reported Event|CF101 0.1mg|CF101 0.1mg q12 for 12 weeks
432236|NCT00556933|B5|Baseline|Total|Total of all reporting groups
432194|NCT00565110|O1|Outcome|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
432195|NCT00565110|E2|Reported Event|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
432196|NCT00565110|E1|Reported Event|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
432197|NCT00565136|B1|Baseline|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432198|NCT00565136|P1|Participant Flow|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432199|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432200|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432201|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432202|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432203|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432204|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432205|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432206|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432207|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432208|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432209|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432210|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432211|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432212|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432213|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432214|NCT00565136|E1|Reported Event|TOPAS|"TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
432215|NCT00565266|B1|Baseline|All Participants|All participants randomized into the six-sequence crossover study
432216|NCT00565266|P1|Participant Flow|All Participants|"All participants randomized into the six-sequence crossover study. All TALC participants underwent three 16-week treatment periods:
tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
beclomethasone dipropionate 160 mcg twice daily (2xICS)"
432217|NCT00565266|O3|Outcome|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
432218|NCT00565266|O2|Outcome|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
432219|NCT00565266|O1|Outcome|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
432220|NCT00565266|E3|Reported Event|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
432221|NCT00565266|E2|Reported Event|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
432222|NCT00565266|E1|Reported Event|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
432223|NCT00556894|B4|Baseline|Total|Total of all reporting groups
432224|NCT00556894|B3|Baseline|Placebo|CF101: orally q12h
432225|NCT00556894|B2|Baseline|CF101 1mg|CF101: orally q12h
432226|NCT00556894|B1|Baseline|CF101 0.1mg|CF101: orally q12h
432227|NCT00556894|P3|Participant Flow|Placebo|Matching placebo
432228|NCT00556894|P2|Participant Flow|CF101 1mg|CF101 1mg orally q12 for 12 weeks
432229|NCT00556894|P1|Participant Flow|CF101 0.1mg|CF101 0.1mg orally q12 for 12 weeks
432230|NCT00556894|O3|Outcome|Placebo|
432231|NCT00556894|O2|Outcome|CF101 1mg|
432237|NCT00556933|B4|Baseline|Divided-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofeti|"Kidney transplant receive the same treatment as in Group 2, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.."
432238|NCT00556933|B3|Baseline|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant receive the same treatment as in Group 1, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432239|NCT00556933|B2|Baseline|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant patients receive 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.
Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432240|NCT00556933|B1|Baseline|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant patients receive 6 mg/kg of rATG as a single dose administered intravenously over <24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.
Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432241|NCT00556933|P4|Participant Flow|Divided-dose rATG (1.5mg/kgx4),Sirolimus/Mycophenolate Mofetil|Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG, 1.5 mg/kg x 4) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
432242|NCT00556933|P3|Participant Flow|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG, 6 mg/kg x 1) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
432243|NCT00556933|P2|Participant Flow|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|Kidney transplant recipients given 4 small doses (1.5 mg/kg) of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
432244|NCT00556933|P1|Participant Flow|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) (6 mg/kg) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
432245|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
432246|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
432247|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
439661|NCT00577135|O4|Outcome|High Intensification|
432248|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432249|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
432250|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
432251|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432252|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432253|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
432254|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
432255|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
433163|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
432256|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432257|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.
mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
432258|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
432259|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432260|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432261|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
432262|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
432263|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432264|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432265|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
432266|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
432267|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432268|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432269|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
432270|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
432271|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
433164|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
432272|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432273|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4), Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
432274|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
432275|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432276|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432277|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
432278|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
432279|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
433165|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
432280|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432281|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
432282|NCT00556933|O3|Outcome|Ingle-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
432283|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432284|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432285|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.
mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
432286|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
432287|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432288|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432289|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
432290|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
432291|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432292|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432293|NCT00556933|E4|Reported Event|Group 4|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.
mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
432294|NCT00556933|E3|Reported Event|Group 3|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
432295|NCT00556933|E2|Reported Event|Group 2|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
433166|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
432296|NCT00556933|E1|Reported Event|Group 1|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
432297|NCT00556946|B1|Baseline|Combined Photodynamic and Pulsed Dye Laser Treatment|Treatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser.
432298|NCT00556946|P1|Participant Flow|Combined Photodynamic and Pulsed Dye Laser Treatment|Treatment of Port Wine Stains: using Combined Photodynamic and Pulsed Dye Laser.
432299|NCT00556946|O1|Outcome|Treatment of Port Wine Stains|"Treatment of Port Wine Stains
Treatment of Port Wine Stains: Treatment of Port Wine Stains"
432300|NCT00556946|E1|Reported Event|Treatment of Port Wine Stains|"Treatment of Port Wine Stains
Treatment of Port Wine Stains: Treatment of Port Wine Stains"
432301|NCT00556972|B1|Baseline|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
432302|NCT00556972|P1|Participant Flow|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
432303|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
432304|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
432305|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
432306|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
432307|NCT00556972|E1|Reported Event|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
432308|NCT00556998|B1|Baseline|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
432309|NCT00556998|P1|Participant Flow|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
432310|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
432311|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
432312|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
432313|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
432314|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
432315|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
432316|NCT00556998|O1|Outcome|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2-7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
432317|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
432318|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
432319|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
432320|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
432321|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
432322|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
439662|NCT00577135|O3|Outcome|Low Intensification|
432323|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
432324|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
432325|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
432326|NCT00556998|E2|Reported Event|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
432327|NCT00556998|E1|Reported Event|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
432328|NCT00557076|B3|Baseline|Total|Total of all reporting groups
432329|NCT00557076|B2|Baseline|Sham|"sham auditory stimulation
Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
432330|NCT00557076|B1|Baseline|FAST|"high dose of familiar voice stimulation
Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
432331|NCT00557076|P2|Participant Flow|Sham|"sham auditory stimulation
Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
432332|NCT00557076|P1|Participant Flow|FAST|"high dose of familiar voice stimulation
Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
432333|NCT00557076|O2|Outcome|Sham|"sham auditory stimulation
Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
432334|NCT00557076|O1|Outcome|FAST|"high dose of familiar voice stimulation
Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
432335|NCT00557076|O2|Outcome|Sham|"sham auditory stimulation
Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
432336|NCT00557076|O1|Outcome|FAST|"high dose of familiar voice stimulation
Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
432337|NCT00557076|E2|Reported Event|Sham|"sham auditory stimulation
Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
432338|NCT00557076|E1|Reported Event|FAST|"high dose of familiar voice stimulation
Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
432339|NCT00557245|B4|Baseline|Total|Total of all reporting groups
432340|NCT00557245|B3|Baseline|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
432341|NCT00557245|B2|Baseline|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432342|NCT00557245|B1|Baseline|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432343|NCT00557245|P3|Participant Flow|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
432344|NCT00557245|P2|Participant Flow|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432345|NCT00557245|P1|Participant Flow|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432346|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
432347|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432348|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432349|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
432350|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432351|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432352|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
433167|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
432353|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432354|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432355|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
432356|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432357|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432358|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
432359|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432360|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432361|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
432362|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432363|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432364|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
432365|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432366|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432367|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
432368|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432369|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432370|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
432371|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432372|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432373|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
432374|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432375|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432376|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
432377|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432378|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432379|NCT00557245|E3|Reported Event|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
432380|NCT00557245|E2|Reported Event|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
432381|NCT00557245|E1|Reported Event|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
432382|NCT00557284|B3|Baseline|Total|Total of all reporting groups
432383|NCT00557284|B2|Baseline|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
432384|NCT00557284|B1|Baseline|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
432385|NCT00557284|P2|Participant Flow|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
432386|NCT00557284|P1|Participant Flow|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
432387|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
432388|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
432389|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
432390|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
432391|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
432392|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
432393|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
432394|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
432395|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
432396|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
432397|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
432398|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
432399|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
432400|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
432401|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
432402|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
432403|NCT00557284|E2|Reported Event|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
432404|NCT00557284|E1|Reported Event|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
432405|NCT00557310|B1|Baseline|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432406|NCT00557310|P1|Participant Flow|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432407|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432408|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432409|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432410|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432411|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432412|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432413|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432414|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432415|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432416|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432417|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432418|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432419|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432420|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432421|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432422|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432423|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432424|NCT00557310|E1|Reported Event|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
432425|NCT00557323|B1|Baseline|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
432426|NCT00557323|P1|Participant Flow|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
432427|NCT00557323|O1|Outcome|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
432428|NCT00557323|O1|Outcome|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
432459|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole Voriconazole prepared as a 1% solution.
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
432460|NCT00557362|E4|Reported Event|Topical Natamycin Without Corneal De-epithelialization|Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
439663|NCT00577135|O2|Outcome|Continuous Infusion|
432429|NCT00557323|E1|Reported Event|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
432430|NCT00557349|B3|Baseline|Total|Total of all reporting groups
432431|NCT00557349|B2|Baseline|Famotidine|40 mg daily for 14 weeks
432432|NCT00557349|B1|Baseline|Omeprazole|40 mg daily for 14 weeks
432433|NCT00557349|P2|Participant Flow|Famotidine|40 mg daily at bedtime for 14 weeks
432434|NCT00557349|P1|Participant Flow|Omeprazole|40 mg daily at bedtime for 14 weeks
432435|NCT00557349|O2|Outcome|Famotidine|40 mg daily at bedtime for 14 weeks
432436|NCT00557349|O1|Outcome|Omeprazole|40 mg daily at bedtime for 14 weeks
432437|NCT00557349|O2|Outcome|Famotidine|40 mg daily at bedtime for 14 weeks
432438|NCT00557349|O1|Outcome|Omeprazole|40 mg daily at bedtime for 14 weeks
432439|NCT00557349|E2|Reported Event|Famotidine|40 mg daily for 14 weeks
432440|NCT00557349|E1|Reported Event|Omeprazole|40 mg daily for 14 weeks
432441|NCT00557362|B5|Baseline|Total|Total of all reporting groups
432442|NCT00557362|B4|Baseline|Topical Natamycin Without Corneal De-epithelialization|Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
432443|NCT00557362|B3|Baseline|Topical Natamycin With Corneal De-epithelialization|"Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
432444|NCT00557362|B2|Baseline|Topical Voriconazole Without Corneal De-epithelialization|Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
432445|NCT00557362|B1|Baseline|Topical Voriconazole With Corneal De-epithelialization|"Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake
Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
432446|NCT00557362|P4|Participant Flow|Topical Voriconazole Without Corneal De-epithelialization|"Topical voriconazole without corneal de-epithelialization.
Drug: Voriconazole Voriconazole prepared as a 1% solution.
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
432447|NCT00557362|P3|Participant Flow|Topical Voriconazole With Corneal De-epithelialization|"Topical voriconazole with corneal de-epithelialization.
Drug: Voriconazole Voriconazole prepared as a 1% solution.
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
432448|NCT00557362|P2|Participant Flow|Topical Natamycin Without Corneal De-epithelialization|"Topical natamycin without corneal de-epithelialization.
Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
432449|NCT00557362|P1|Participant Flow|Topical Natamycin With Corneal De-epithelialization|"Topical natamycin with corneal de-epithelialization.
Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
432450|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
432451|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole
Voriconazole prepared as a 1% solution.
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
432452|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
432453|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole
Voriconazole prepared as a 1% solution.
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
432454|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Note that 5 patients in the natamycin arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses."
432455|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole
Voriconazole prepared as a 1% solution.
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Note that 9 patients in the voriconazole arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses."
432456|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake"
432457|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole
Voriconazole prepared as a 1% solution.
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake"
432458|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%
One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
433168|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
432461|NCT00557362|E3|Reported Event|Topical Natamycin With Corneal De-epithelialization|"Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
432462|NCT00557362|E2|Reported Event|Topical Voriconazole Without Corneal De-epithelialization|Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
432463|NCT00557362|E1|Reported Event|Topical Voriconazole With Corneal De-epithelialization|"Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
432464|NCT00557440|B4|Baseline|Total|Total of all reporting groups
432465|NCT00557440|B3|Baseline|Pbo - Ind/M - FP/Salm|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 & 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period."
432466|NCT00557440|B2|Baseline|FP/Salm - Pbo - Ind/M|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 & 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period."
432467|NCT00557440|B1|Baseline|Ind/M - FP/Salm - Pbo|"In Treatment Period 1 (Days 1 & 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period."
432468|NCT00557440|P3|Participant Flow|Pbo - Ind/M - FP/Salm|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 & 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period."
432469|NCT00557440|P2|Participant Flow|FP/Salm - Pbo - Ind/M|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 & 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period."
432470|NCT00557440|P1|Participant Flow|Ind/M - FP/Salm - Pbo|"In Treatment Period 1 (Days 1 & 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.
In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.
Each treatment period was separated by a 6-day washout period."
432471|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
432472|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
432508|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432473|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
432474|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
432475|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
432476|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
432477|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
432478|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
432479|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
432480|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
432481|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
432482|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
432483|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
432484|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
432485|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
432486|NCT00557440|E3|Reported Event|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
432487|NCT00557440|E2|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
432488|NCT00557440|E1|Reported Event|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
432489|NCT00557466|B7|Baseline|Total|Total of all reporting groups
432490|NCT00557466|B6|Baseline|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432491|NCT00557466|B5|Baseline|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
432492|NCT00557466|B4|Baseline|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432493|NCT00557466|B3|Baseline|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432494|NCT00557466|B2|Baseline|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432495|NCT00557466|B1|Baseline|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432496|NCT00557466|P6|Participant Flow|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432497|NCT00557466|P5|Participant Flow|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
432498|NCT00557466|P4|Participant Flow|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432499|NCT00557466|P3|Participant Flow|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432500|NCT00557466|P2|Participant Flow|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432501|NCT00557466|P1|Participant Flow|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432502|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432503|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
432504|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432505|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432506|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432507|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
433169|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
432509|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
432510|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432511|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432512|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432513|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432514|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432515|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
432516|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432517|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432518|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432519|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432520|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432521|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
432522|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432523|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432524|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432525|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432526|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432527|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
432528|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432529|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432530|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432531|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432532|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432533|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
432534|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432535|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432536|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432537|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432538|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432539|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
432540|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432541|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432542|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432543|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432544|NCT00557466|E6|Reported Event|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432545|NCT00557466|E5|Reported Event|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
432546|NCT00557466|E4|Reported Event|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432547|NCT00557466|E3|Reported Event|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432548|NCT00557466|E2|Reported Event|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432549|NCT00557466|E1|Reported Event|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
432550|NCT00557492|B1|Baseline|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432551|NCT00557492|P1|Participant Flow|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432552|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432553|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432554|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432555|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432556|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432557|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432558|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432559|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432560|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432561|NCT00557492|E1|Reported Event|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
432562|NCT00557505|B10|Baseline|Total|Total of all reporting groups
432563|NCT00557505|B9|Baseline|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432564|NCT00557505|B8|Baseline|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432565|NCT00557505|B7|Baseline|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432566|NCT00557505|B6|Baseline|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432567|NCT00557505|B5|Baseline|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432568|NCT00557505|B4|Baseline|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432569|NCT00557505|B3|Baseline|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432570|NCT00557505|B2|Baseline|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432571|NCT00557505|B1|Baseline|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432572|NCT00557505|P9|Participant Flow|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432573|NCT00557505|P8|Participant Flow|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432574|NCT00557505|P7|Participant Flow|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432575|NCT00557505|P6|Participant Flow|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432576|NCT00557505|P5|Participant Flow|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432577|NCT00557505|P4|Participant Flow|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432578|NCT00557505|P3|Participant Flow|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432579|NCT00557505|P2|Participant Flow|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432580|NCT00557505|P1|Participant Flow|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 milligram per kilogram (mg/kg) intravenously (IV) administered over 1 hour (hr) on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432581|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432582|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432583|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432584|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432585|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432586|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432587|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432588|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432589|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432590|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432591|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432592|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432593|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432594|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432595|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432596|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432597|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432598|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432599|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432600|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432601|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432602|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432603|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432604|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432605|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432606|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432607|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432608|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432609|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432610|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432611|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432612|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432613|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432614|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432615|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432616|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432617|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432618|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432619|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432620|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432621|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432622|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432623|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432624|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432625|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432626|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432627|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432628|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432629|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432630|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432631|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432632|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
433170|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
432633|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432634|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432635|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432636|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432637|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432638|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432639|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432640|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432641|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432642|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432643|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432644|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432645|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432646|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432647|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432648|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432649|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432650|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432651|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432652|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432653|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432654|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432655|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432656|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432657|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432658|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432659|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432660|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432661|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432662|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432663|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
433171|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
432664|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432665|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432666|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432667|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432668|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432669|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432670|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432671|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432672|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432673|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432674|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432675|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432676|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432677|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432678|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432679|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432680|NCT00557505|O3|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432681|NCT00557505|O2|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432682|NCT00557505|O1|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432683|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432684|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432685|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432686|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432687|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432688|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432689|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432690|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432691|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432692|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432693|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432694|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
433172|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
432695|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432696|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432697|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432698|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432699|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432700|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432701|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432702|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432703|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432704|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432705|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432706|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432707|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432708|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432709|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432710|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432711|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432712|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432713|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432714|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432715|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432716|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432717|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432718|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432719|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432720|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432721|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432722|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432723|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432724|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432725|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
433424|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
432726|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432727|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432728|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432729|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432730|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432731|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432732|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432733|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432734|NCT00557505|E9|Reported Event|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432735|NCT00557505|E8|Reported Event|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432736|NCT00557505|E7|Reported Event|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
432737|NCT00557505|E6|Reported Event|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432738|NCT00557505|E5|Reported Event|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432739|NCT00557505|E4|Reported Event|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432740|NCT00557505|E3|Reported Event|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432741|NCT00557505|E2|Reported Event|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432742|NCT00557505|E1|Reported Event|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
432743|NCT00557622|B3|Baseline|Total|Total of all reporting groups
432744|NCT00557622|B2|Baseline|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
432745|NCT00557622|B1|Baseline|Placebo|Placebo once daily (OD)
432746|NCT00557622|P2|Participant Flow|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
432747|NCT00557622|P1|Participant Flow|Placebo|Placebo once daily (OD)
432748|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
432749|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
432750|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
432751|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
432752|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
432753|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
432754|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
432755|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
432756|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
432757|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
433040|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
432758|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
432759|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
432760|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
432761|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
432762|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
432763|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
432764|NCT00557622|E2|Reported Event|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
432765|NCT00557622|E1|Reported Event|Placebo|Placebo once daily (OD)
432766|NCT00557830|B4|Baseline|Total|Total of all reporting groups
432767|NCT00557830|B3|Baseline|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
Sorafenib Standard Dose :
Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
432768|NCT00557830|B2|Baseline|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
Sorafenib Escalated Dose :
Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
432769|NCT00557830|B1|Baseline|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
432770|NCT00557830|P3|Participant Flow|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
Sorafenib Standard Dose :
Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
432771|NCT00557830|P2|Participant Flow|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
Sorafenib Escalated Dose :
Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
432772|NCT00557830|P1|Participant Flow|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
432773|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
Sorafenib Standard Dose :
Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
432774|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
Sorafenib Escalated Dose :
Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
432805|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
439664|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
432775|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
432776|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
Sorafenib Standard Dose :
Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
432777|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
Sorafenib Escalated Dose :
Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
432778|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
432779|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
Sorafenib Standard Dose :
Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
432780|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
Sorafenib Escalated Dose :
Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
432781|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
432782|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
Sorafenib Standard Dose :
Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
432783|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
Sorafenib Escalated Dose :
Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
432784|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
432785|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
Sorafenib Standard Dose :
Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
432806|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432786|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
Sorafenib Escalated Dose :
Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
432787|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
432788|NCT00557830|E3|Reported Event|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
Sorafenib Standard Dose :
Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
432789|NCT00557830|E2|Reported Event|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
Sorafenib Escalated Dose :
Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
432790|NCT00557830|E1|Reported Event|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
432791|NCT00557856|B1|Baseline|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
432792|NCT00557856|P9|Participant Flow|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432793|NCT00557856|P8|Participant Flow|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432794|NCT00557856|P7|Participant Flow|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432795|NCT00557856|P6|Participant Flow|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432796|NCT00557856|P5|Participant Flow|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432797|NCT00557856|P4|Participant Flow|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432798|NCT00557856|P3|Participant Flow|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432799|NCT00557856|P2|Participant Flow|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432800|NCT00557856|P1|Participant Flow|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432801|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432802|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432803|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432804|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
433039|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
432807|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432808|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432809|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432810|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432811|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432812|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432813|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432814|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432815|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432816|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432817|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432818|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432819|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432820|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432821|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432822|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432823|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432824|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432825|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432826|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432827|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432828|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432829|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432830|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432831|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432832|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432833|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
439665|NCT00577135|O4|Outcome|High Intensification|
432834|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432835|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432836|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432837|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432838|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432839|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432840|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432841|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432842|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432843|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432844|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432845|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432846|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432847|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432848|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432849|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432850|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432851|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432852|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432853|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432854|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432855|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432856|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432857|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432858|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432859|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432860|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
439666|NCT00577135|O3|Outcome|Low Intensification|
432861|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432862|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432863|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432864|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432865|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432866|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432867|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432868|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432869|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432870|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432871|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432872|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432873|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432874|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432875|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432876|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432877|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432878|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432879|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432880|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432881|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432882|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432883|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432884|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432885|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432886|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432887|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
439667|NCT00577135|O2|Outcome|Continuous Infusion|
432888|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432889|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432890|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432891|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432892|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432893|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432894|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432895|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432896|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432897|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432898|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432899|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432900|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432901|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432902|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432903|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432904|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432905|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432906|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432907|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432908|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432909|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432910|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432911|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432912|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432913|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432914|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
439668|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
432915|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432916|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432917|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432918|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432919|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432920|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432921|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432922|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432923|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432924|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432925|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432926|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432927|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432928|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432929|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432930|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432931|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432932|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432933|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432934|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432935|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432936|NCT00557856|O1|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432937|NCT00557856|O1|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432938|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432939|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432940|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432941|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
439669|NCT00577135|O4|Outcome|High Intensification|
432942|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432943|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432944|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432945|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432946|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432947|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432948|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432949|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432950|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432951|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432952|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432953|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432954|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432955|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432956|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432957|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432958|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432959|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432960|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432961|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432962|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432963|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432964|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432965|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432966|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432967|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432968|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
439670|NCT00577135|O3|Outcome|Low Intensification|
432969|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432970|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432971|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432972|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432973|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432974|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432975|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432976|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432977|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432978|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432979|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432980|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432981|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432982|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432983|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432984|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432985|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432986|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432987|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432988|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432989|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432990|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432991|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
432992|NCT00557856|O1|Outcome|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
432993|NCT00557856|O1|Outcome|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
432994|NCT00557856|E1|Reported Event|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
433159|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
432995|NCT00557947|B1|Baseline|Dermabond Protape/Suture|Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
432996|NCT00557947|P1|Participant Flow|Dermabond Protape/Suture|Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
432997|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
432998|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
432999|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
433000|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
433001|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
433002|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
433003|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
433004|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
433005|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
433006|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
433007|NCT00557947|E4|Reported Event|Unrelated|Reported events per local regulatory requirements but not related to either device or procedure.
433008|NCT00557947|E3|Reported Event|Procedure|
433009|NCT00557947|E2|Reported Event|Suture|Suture - Incision segments are randomized & patient is own control.
433010|NCT00557947|E1|Reported Event|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
433011|NCT00558012|B3|Baseline|Total|Total of all reporting groups
433012|NCT00558012|B2|Baseline|Placebo|"Placebo
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
433013|NCT00558012|B1|Baseline|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
433014|NCT00558012|P2|Participant Flow|Placebo|"Placebo
One-time dose: Intravenous saline"
433015|NCT00558012|P1|Participant Flow|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
433016|NCT00558012|O2|Outcome|Placebo|"Placebo
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
433017|NCT00558012|O1|Outcome|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
433018|NCT00558012|E2|Reported Event|Placebo|"Placebo
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
433019|NCT00558012|E1|Reported Event|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
433020|NCT00558025|B3|Baseline|Total|Total of all reporting groups
433021|NCT00558025|B2|Baseline|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
433022|NCT00558025|B1|Baseline|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
433023|NCT00558025|P2|Participant Flow|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
433024|NCT00558025|P1|Participant Flow|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d. (Quaque die, once per day), per os
433025|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
433026|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
433027|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
433028|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
433029|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
433030|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
433031|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
433032|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
433033|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
433034|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
433035|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
433036|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
433037|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
433038|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
439671|NCT00577135|O2|Outcome|Continuous Infusion|
433041|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
433042|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
433043|NCT00558025|E2|Reported Event|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
433044|NCT00558025|E1|Reported Event|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
433045|NCT00558064|B3|Baseline|Total|Total of all reporting groups
433046|NCT00558064|B2|Baseline|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
433047|NCT00558064|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
433048|NCT00558064|P2|Participant Flow|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
433049|NCT00558064|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
433050|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
433051|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
433052|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
433053|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
433054|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
433055|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
433056|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
433057|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
433058|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
433059|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
433060|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
433061|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
433062|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
433063|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
433064|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
433065|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
433066|NCT00558064|E2|Reported Event|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
433067|NCT00558064|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
433068|NCT00558103|B6|Baseline|Total|Total of all reporting groups
433069|NCT00558103|B5|Baseline|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433070|NCT00558103|B4|Baseline|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
433071|NCT00558103|B3|Baseline|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433072|NCT00558103|B2|Baseline|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
433073|NCT00558103|B1|Baseline|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
433074|NCT00558103|P6|Participant Flow|Open-label Lapatinib 1500 mg|Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
433075|NCT00558103|P5|Participant Flow|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433076|NCT00558103|P4|Participant Flow|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
433077|NCT00558103|P3|Participant Flow|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433078|NCT00558103|P2|Participant Flow|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
433079|NCT00558103|P1|Participant Flow|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
433160|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433080|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433081|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
433082|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433083|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
433084|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
433085|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433086|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
433087|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433088|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
433089|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
433090|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433091|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
433092|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433093|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
433094|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
433095|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433096|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
433097|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433098|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
433099|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
433100|NCT00558103|E6|Reported Event|Open-label Lapatinib 1500 mg|Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
433101|NCT00558103|E5|Reported Event|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433102|NCT00558103|E4|Reported Event|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
433161|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433103|NCT00558103|E3|Reported Event|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
433104|NCT00558103|E2|Reported Event|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
433105|NCT00558103|E1|Reported Event|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
433106|NCT00558246|B1|Baseline|Prineo and Suture|On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
433107|NCT00558246|P1|Participant Flow|Prineo and Suture|On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
433108|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433109|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433110|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433111|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433112|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433113|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433114|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433115|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433116|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433117|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433118|NCT00558246|E3|Reported Event|Procedure|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433119|NCT00558246|E2|Reported Event|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433120|NCT00558246|E1|Reported Event|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
433121|NCT00558259|B3|Baseline|Total|Total of all reporting groups
433122|NCT00558259|B2|Baseline|Placebo|Matching placebo
433123|NCT00558259|B1|Baseline|Dabigatran|Dabigatran 150mg bid
433124|NCT00558259|P2|Participant Flow|Placebo|Matching placebo
433125|NCT00558259|P1|Participant Flow|Dabigatran|Dabigatran 150mg bid (twice daily)
433126|NCT00558259|O2|Outcome|Placebo|Matching placebo
433127|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
433128|NCT00558259|O2|Outcome|Placebo|Matching placebo
433129|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
433130|NCT00558259|O2|Outcome|Placebo|Matching placebo
433131|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
433132|NCT00558259|O2|Outcome|Placebo|Matching placebo
433133|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
433134|NCT00558259|O2|Outcome|Placebo|Matching placebo
433135|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
433136|NCT00558259|O2|Outcome|Placebo|Matching placebo
433137|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
433138|NCT00558259|O2|Outcome|Placebo|Matching placebo
433139|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
433140|NCT00558259|O2|Outcome|Placebo|Matching placebo
433141|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
433142|NCT00558259|E2|Reported Event|Placebo|Matching placebo
433143|NCT00558259|E1|Reported Event|Dabigatran|Dabigatran 150mg bid
433144|NCT00558272|B3|Baseline|Total|Total of all reporting groups
433145|NCT00558272|B2|Baseline|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433146|NCT00558272|B1|Baseline|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433147|NCT00558272|P2|Participant Flow|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433148|NCT00558272|P1|Participant Flow|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433149|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433150|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433151|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433152|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433153|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433154|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433155|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433156|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433157|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433158|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433173|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433174|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433175|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433176|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433177|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433178|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433179|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433180|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433181|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433182|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433183|NCT00558272|E2|Reported Event|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
433184|NCT00558272|E1|Reported Event|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
433185|NCT00558285|B6|Baseline|Total|Total of all reporting groups
433186|NCT00558285|B5|Baseline|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433187|NCT00558285|B4|Baseline|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433188|NCT00558285|B3|Baseline|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433189|NCT00558285|B2|Baseline|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433190|NCT00558285|B1|Baseline|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433191|NCT00558285|P5|Participant Flow|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433192|NCT00558285|P4|Participant Flow|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433193|NCT00558285|P3|Participant Flow|Indacaterol/Glycopyrrolate 150 μg/100 μg|"One capsule indacaterol/glycopyrrolate 150 μg/50 μg and one capsule 50μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433194|NCT00558285|P2|Participant Flow|Indacaterol/Glycopyrrolate 300 μg/100 μg|"One capsule indacaterol/glycopyrrolate 300 μg/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433195|NCT00558285|P1|Participant Flow|Indacaterol/Glycopyrrolate 600 μg/100 μg|"Two capsules indacaterol/glycopyrrolate 300 μg/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433196|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433197|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433198|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433199|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433200|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433201|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433202|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433203|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433204|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433205|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433283|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433206|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433207|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433208|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433209|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433210|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433211|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433212|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433213|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433214|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433215|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433216|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433217|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433218|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433219|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433220|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433221|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433222|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433223|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433224|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433225|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433226|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433227|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433228|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433229|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433230|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433231|NCT00558285|E5|Reported Event|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol /albuterol as rescue medication was permitted throughout the study."
433232|NCT00558285|E4|Reported Event|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433233|NCT00558285|E3|Reported Event|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433234|NCT00558285|E2|Reported Event|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433235|NCT00558285|E1|Reported Event|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
433236|NCT00558363|B3|Baseline|Total|Total of all reporting groups
433237|NCT00558363|B2|Baseline|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433238|NCT00558363|B1|Baseline|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433239|NCT00558363|P2|Participant Flow|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433240|NCT00558363|P1|Participant Flow|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433241|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433242|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433243|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433244|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433245|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433246|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433247|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433248|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433249|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433250|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433251|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433252|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433253|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433254|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433255|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433256|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433257|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433258|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433259|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433260|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433261|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433262|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433263|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433264|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433265|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433266|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433267|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433268|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433269|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433270|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433271|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433272|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433273|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433274|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433275|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433276|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433277|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433278|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433279|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433280|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433281|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433282|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433284|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433285|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433286|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433287|NCT00558363|E2|Reported Event|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
433288|NCT00558363|E1|Reported Event|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
433289|NCT00558428|B5|Baseline|Total|Total of all reporting groups
433290|NCT00558428|B4|Baseline|Telmisartan 80mg and Amlodipine 5mg|
433291|NCT00558428|B3|Baseline|Telmisartan 40mg and Amlodipine 5mg|
433292|NCT00558428|B2|Baseline|Amlodipine 10mg|
433293|NCT00558428|B1|Baseline|Amlodipine 5mg|
433294|NCT00558428|P4|Participant Flow|Telmisartan 80mg and Amlodipine 5mg|
433295|NCT00558428|P3|Participant Flow|Telmisartan 40mg and Amlodipine 5mg|
433296|NCT00558428|P2|Participant Flow|Amlodipine 10mg|
433297|NCT00558428|P1|Participant Flow|Amlodipine 5mg|
433298|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
433299|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
433300|NCT00558428|O2|Outcome|Amlodipine 10mg|
433301|NCT00558428|O1|Outcome|Amlodipine 5mg|
433302|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
433303|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
433304|NCT00558428|O2|Outcome|Amlodipine 10mg|
433305|NCT00558428|O1|Outcome|Amlodipine 5mg|
433306|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
433307|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
433308|NCT00558428|O2|Outcome|Amlodipine 10mg|
433309|NCT00558428|O1|Outcome|Amlodipine 5mg|
433310|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
433311|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
433312|NCT00558428|O2|Outcome|Amlodipine 10mg|
433313|NCT00558428|O1|Outcome|Amlodipine 5mg|
433314|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
433315|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
433316|NCT00558428|O2|Outcome|Amlodipine 10mg|
433317|NCT00558428|O1|Outcome|Amlodipine 5mg|
433318|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
433319|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
433320|NCT00558428|O2|Outcome|Amlodipine 10mg|
433321|NCT00558428|O1|Outcome|Amlodipine 5mg|
433322|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
433323|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
433324|NCT00558428|O2|Outcome|Amlodipine 10mg|
433325|NCT00558428|O1|Outcome|Amlodipine 5mg|
433326|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
433327|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
433328|NCT00558428|O2|Outcome|Amlodipine 10mg|
433329|NCT00558428|O1|Outcome|Amlodipine 5mg|
433330|NCT00558428|E4|Reported Event|Telmisartan 80mg and Amlodipine 5mg|
433331|NCT00558428|E3|Reported Event|Telmisartan 40mg and Amlodipine 5mg|
433332|NCT00558428|E2|Reported Event|Amlodipine 10mg|
433333|NCT00558428|E1|Reported Event|Amlodipine 5mg|
433334|NCT00558467|B3|Baseline|Total|Total of all reporting groups
433335|NCT00558467|B2|Baseline|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433336|NCT00558467|B1|Baseline|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433337|NCT00558467|P2|Participant Flow|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433338|NCT00558467|P1|Participant Flow|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433339|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433340|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433341|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433342|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433343|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433344|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433345|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433346|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433423|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
433347|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433348|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433349|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433350|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433351|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433352|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433353|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433354|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433355|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433356|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433357|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433358|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433359|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433360|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433361|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433362|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433363|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433364|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433365|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433366|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433367|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433368|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433369|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433370|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433371|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433372|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433373|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433374|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433375|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433376|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
439672|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
433377|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433378|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433379|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433380|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433381|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433382|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433383|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433384|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433385|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433386|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433387|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433388|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433389|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433390|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433391|NCT00558467|E2|Reported Event|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
433392|NCT00558467|E1|Reported Event|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
433393|NCT00558558|B1|Baseline|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
433394|NCT00558558|P1|Participant Flow|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
433395|NCT00558558|O1|Outcome|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
433396|NCT00558558|E1|Reported Event|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
433397|NCT00558571|B5|Baseline|Total|Total of all reporting groups
433398|NCT00558571|B4|Baseline|100mg Empagliflozin|oral administration in the fasted state once daily.
433399|NCT00558571|B3|Baseline|25mg Empagliflozin|oral administration in the fasted state once daily.
433400|NCT00558571|B2|Baseline|10mg Empagliflozin|oral administration in the fasted state once daily.
433401|NCT00558571|B1|Baseline|Placebo|oral administration in the fasted state once daily.
433402|NCT00558571|P4|Participant Flow|100mg Empagliflozin|Oral administration in the fasted state once daily.
433403|NCT00558571|P3|Participant Flow|25mg Empagliflozin|Oral administration in the fasted state once daily.
433404|NCT00558571|P2|Participant Flow|10mg Empagliflozin|Oral administration in the fasted state once daily.
433405|NCT00558571|P1|Participant Flow|Placebo|Oral administration in the fasted state once daily
433406|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily
433407|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily
433408|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily
433409|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily
433410|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433411|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433412|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433413|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
433414|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433415|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433416|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433417|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
433418|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433419|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433420|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433421|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
433422|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
433425|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
433426|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433427|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433428|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433429|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
433430|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433431|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433432|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433433|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
433434|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433435|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433436|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433437|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
433438|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
433439|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
433440|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
433441|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
433442|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433443|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433444|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433445|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
433446|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433447|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433448|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433449|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433450|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433451|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433452|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433453|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433454|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433455|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433456|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433457|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433458|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433459|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433460|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433461|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433462|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433463|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433464|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
433465|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
433466|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
433467|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
433468|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
433469|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
433470|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
433471|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
433472|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
433473|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
433474|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
433475|NCT00558571|E4|Reported Event|100mg Empagliflozin|oral administration in the fasted state once daily
433476|NCT00558571|E3|Reported Event|25mg Empagliflozin|oral administration in the fasted state once daily
433477|NCT00558571|E2|Reported Event|10mg Empagliflozin|oral administration in the fasted state once daily
433478|NCT00558571|E1|Reported Event|Placebo|oral administration in the fasted state once daily
433479|NCT00558636|B3|Baseline|Total|Total of all reporting groups
433480|NCT00558636|B2|Baseline|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
433481|NCT00558636|B1|Baseline|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
433602|NCT00558896|P1|Participant Flow|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433482|NCT00558636|P2|Participant Flow|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
433483|NCT00558636|P1|Participant Flow|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
433484|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
433485|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
433486|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
433487|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
433488|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
433489|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
433490|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
433491|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
433492|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
433493|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
433494|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
433495|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
433496|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
433497|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
433498|NCT00558636|E2|Reported Event|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
433499|NCT00558636|E1|Reported Event|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
433500|NCT00558701|B3|Baseline|Total|Total of all reporting groups
433501|NCT00558701|B2|Baseline|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)
Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
433534|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
439673|NCT00577135|E4|Reported Event|High Intensification|
433502|NCT00558701|B1|Baseline|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing.
Intervention is active electrical stimulation via microcurrent stimulator.
Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
433503|NCT00558701|P2|Participant Flow|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)
Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
433504|NCT00558701|P1|Participant Flow|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.
Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps
Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
433505|NCT00558701|O2|Outcome|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)
Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
433506|NCT00558701|O1|Outcome|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.
Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps
Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
433507|NCT00558701|E2|Reported Event|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)
Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
433508|NCT00558701|E1|Reported Event|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.
Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps
Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
433509|NCT00558753|B3|Baseline|Total|Total of all reporting groups
433510|NCT00558753|B2|Baseline|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
433511|NCT00558753|B1|Baseline|1 Placebo|Half of the patients will receive PO placebo for 14 days
433512|NCT00558753|P2|Participant Flow|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
433513|NCT00558753|P1|Participant Flow|1 Placebo|Half of the patients will receive oral (PO) placebo for 14 days
433514|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
433515|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
433516|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
433517|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
433518|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
433519|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
433520|NCT00558753|E2|Reported Event|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
433521|NCT00558753|E1|Reported Event|1 Placebo|Half of the patients will receive PO placebo for 14 days
433522|NCT00558792|B4|Baseline|Total|Total of all reporting groups
433523|NCT00558792|B3|Baseline|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
433524|NCT00558792|B2|Baseline|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
433525|NCT00558792|B1|Baseline|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
433526|NCT00558792|P3|Participant Flow|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
433527|NCT00558792|P2|Participant Flow|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
433528|NCT00558792|P1|Participant Flow|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
433529|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433530|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433531|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
433532|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433533|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433535|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433536|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433537|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
433538|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433539|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433540|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
433541|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433542|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433543|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
433544|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433545|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433546|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
433547|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433548|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433549|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
433550|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433551|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433552|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
433553|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433554|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433555|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
433556|NCT00558792|O3|Outcome|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
433557|NCT00558792|O2|Outcome|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
433558|NCT00558792|O1|Outcome|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
433559|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433560|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433561|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
433562|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433563|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
434086|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
433564|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
433565|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433566|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
433567|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
433568|NCT00558792|E3|Reported Event|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
433569|NCT00558792|E2|Reported Event|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
433570|NCT00558792|E1|Reported Event|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
433571|NCT00558831|B1|Baseline|Subjects|Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
433572|NCT00558831|P1|Participant Flow|Subjects|Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
433573|NCT00558831|O2|Outcome|Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion|
433574|NCT00558831|O1|Outcome|Benzoyl Peroxide 2.5% Cream|
433575|NCT00558831|E2|Reported Event|Benzoyl Peroxide 2.5% Plus Moisturizing Lotion|
433576|NCT00558831|E1|Reported Event|Benzoyl Peroxide 2.5%|
433577|NCT00558870|B3|Baseline|Total|Total of all reporting groups
433578|NCT00558870|B2|Baseline|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
433579|NCT00558870|B1|Baseline|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
433580|NCT00558870|P2|Participant Flow|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
433581|NCT00558870|P1|Participant Flow|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
433582|NCT00558870|O2|Outcome|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
433583|NCT00558870|O1|Outcome|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
433584|NCT00558870|O2|Outcome|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
433585|NCT00558870|O1|Outcome|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
433586|NCT00558870|E2|Reported Event|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
433587|NCT00558870|E1|Reported Event|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
433588|NCT00558896|B8|Baseline|Total|Total of all reporting groups
433589|NCT00558896|B7|Baseline|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433590|NCT00558896|B6|Baseline|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433591|NCT00558896|B5|Baseline|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433592|NCT00558896|B4|Baseline|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433593|NCT00558896|B3|Baseline|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433594|NCT00558896|B2|Baseline|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433595|NCT00558896|B1|Baseline|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433596|NCT00558896|P7|Participant Flow|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433597|NCT00558896|P6|Participant Flow|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433598|NCT00558896|P5|Participant Flow|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433599|NCT00558896|P4|Participant Flow|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433600|NCT00558896|P3|Participant Flow|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433601|NCT00558896|P2|Participant Flow|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433603|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433604|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433605|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433606|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433607|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433608|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433609|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433610|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433611|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433612|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433613|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433614|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433615|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433616|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433617|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433618|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433619|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433620|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433621|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433622|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433623|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433624|NCT00558896|E7|Reported Event|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433625|NCT00558896|E6|Reported Event|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433626|NCT00558896|E5|Reported Event|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433627|NCT00558896|E4|Reported Event|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433628|NCT00558896|E3|Reported Event|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433629|NCT00558896|E2|Reported Event|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433630|NCT00558896|E1|Reported Event|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
433631|NCT00559013|B1|Baseline|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
433632|NCT00559013|P1|Participant Flow|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
433633|NCT00559013|O1|Outcome|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
433634|NCT00559013|E1|Reported Event|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
433635|NCT00559104|B3|Baseline|Total|Total of all reporting groups
433636|NCT00559104|B2|Baseline|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF"
439674|NCT00577135|E3|Reported Event|Low Intensification|
433637|NCT00559104|B1|Baseline|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF"
433638|NCT00559104|P2|Participant Flow|nonTBI-based Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF"
433639|NCT00559104|P1|Participant Flow|TBI-based Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF"
433640|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF"
433641|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF"
433642|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF"
433643|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF"
433644|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF"
433645|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF"
433646|NCT00559104|E2|Reported Event|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF"
433647|NCT00559104|E1|Reported Event|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF"
433648|NCT00559273|B3|Baseline|Total|Total of all reporting groups
433649|NCT00559273|B2|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
433650|NCT00559273|B1|Baseline|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
433651|NCT00559273|P2|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
433652|NCT00559273|P1|Participant Flow|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 microgram per kilogram (mcg/kg) once every 4 weeks for 28 weeks.
433653|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
433654|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
433655|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
433656|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
433657|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
433658|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
433659|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
433660|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
433661|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
433662|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
433663|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
433664|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
433665|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
434087|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
433666|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
433667|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
433668|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
433669|NCT00559273|E2|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
433670|NCT00559273|E1|Reported Event|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
433671|NCT00559364|B3|Baseline|Total|Total of all reporting groups
433672|NCT00559364|B2|Baseline|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433673|NCT00559364|B1|Baseline|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433674|NCT00559364|P2|Participant Flow|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433675|NCT00559364|P1|Participant Flow|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433676|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433677|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433678|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433679|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433680|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433681|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433682|NCT00559364|E2|Reported Event|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433683|NCT00559364|E1|Reported Event|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
433684|NCT00559377|B1|Baseline|All Patients|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later.
433685|NCT00559377|P1|Participant Flow|Diagnostic (^18F FMISO PET and ^18F FDG PET)|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
433686|NCT00559377|O1|Outcome|Patients Who Had Response Determined by Clinical RECIST|
433687|NCT00559377|O1|Outcome|Patients With IHC Measures|Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.
433688|NCT00559377|O1|Outcome|Patients With IHC Measures|Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.
433689|NCT00559377|O1|Outcome|Disease-Free Survival|Patients who have remained disease-free throughout the 2 year follow up
433690|NCT00559377|O1|Outcome|2 Year Overall Survival|Patients who have not been declared deceased for 2 years after their last FMISO scan.
434088|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
433691|NCT00559377|E1|Reported Event|Diagnostic (^18F FMISO PET and ^18F FDG PET)|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
433692|NCT00565370|B1|Baseline|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
433693|NCT00565370|P1|Participant Flow|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib Level 1 sorafenib 400 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 2 sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 3 sorafenib 800 mg/d, capecitabine 2,000 mg/m2/d, cisplatin 80 mg/m2 Level 1A sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 60 mg/m2
433694|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
433695|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
433696|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
433697|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
433698|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
433699|NCT00565370|E1|Reported Event|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
433700|NCT00565409|B1|Baseline|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433701|NCT00565409|P4|Participant Flow|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
433702|NCT00565409|P3|Participant Flow|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
433703|NCT00565409|P2|Participant Flow|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) less than or equal to (≤) 3.2 at Week 36 and an average DAS28 less than or equal to (≤) 3.2 from Week 12 visit through Week 36.
433704|NCT00565409|P1|Participant Flow|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept (ETN) 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433705|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433706|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433707|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433708|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433709|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433710|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433711|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433712|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433713|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433714|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433715|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433716|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433717|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433718|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433719|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433720|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433721|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433722|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433723|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433724|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433725|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433726|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433727|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433728|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433729|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433730|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433731|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433732|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433733|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433734|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433735|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433736|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433737|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433738|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433739|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433740|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433741|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433742|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433743|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433744|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433745|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433746|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433747|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433748|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433749|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433750|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433751|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433752|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433753|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433754|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433755|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433756|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433757|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433758|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433759|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433760|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433761|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433762|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433763|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433764|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433765|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
434089|NCT00566852|E2|Reported Event|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
433766|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433767|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433768|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433769|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433770|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433771|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433772|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433773|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433774|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433775|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433776|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433777|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433778|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433779|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433780|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433781|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433782|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433783|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433784|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433785|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433786|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433787|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433788|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
434090|NCT00566852|E1|Reported Event|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
433789|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433790|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433791|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433792|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433793|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433794|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433795|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433796|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433797|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433798|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433799|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433800|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
433801|NCT00565409|E4|Reported Event|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
433802|NCT00565409|E3|Reported Event|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
433803|NCT00565409|E2|Reported Event|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) less than or equal to (≤) 3.2 at Week 36 and an average DAS28 less than or equal to (≤) 3.2 from Week 12 visit through Week 36.
433804|NCT00565409|E1|Reported Event|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept (ETN) 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
433805|NCT00565448|B3|Baseline|Total|Total of all reporting groups
433806|NCT00565448|B2|Baseline|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
433807|NCT00565448|B1|Baseline|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
433808|NCT00565448|P2|Participant Flow|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy.
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
433809|NCT00565448|P1|Participant Flow|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
433810|NCT00565448|O2|Outcome|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.
Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
433811|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.
Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
433812|NCT00565448|O2|Outcome|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.
Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
434091|NCT00566930|B4|Baseline|Total|Total of all reporting groups
434092|NCT00566930|B3|Baseline|Spinal Manipulation and Exercises|Spinal manipulation + exercises
433813|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.
Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
433814|NCT00565448|O1|Outcome|Docetaxel/Cisplatin/5-FU|Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
433815|NCT00565448|O2|Outcome|Cisplatin/5-FU|Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
433816|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
433817|NCT00565448|E2|Reported Event|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
433818|NCT00565448|E1|Reported Event|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy.
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
433819|NCT00565461|B5|Baseline|Total|Total of all reporting groups
433820|NCT00565461|B4|Baseline|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
433821|NCT00565461|B3|Baseline|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
433822|NCT00565461|B2|Baseline|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
433823|NCT00565461|B1|Baseline|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
433824|NCT00565461|P4|Participant Flow|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
433825|NCT00565461|P3|Participant Flow|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
433826|NCT00565461|P2|Participant Flow|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
433827|NCT00565461|P1|Participant Flow|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
433828|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid
nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
433829|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid
nd vaccination: administered by clinician; location: thigh"
433830|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid
nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
433831|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid
nd vaccination: administered by clinician; location: thigh"
433832|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid
nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
433833|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid
nd vaccination: administered by clinician; location: thigh"
433834|NCT00565461|E4|Reported Event|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
433835|NCT00565461|E3|Reported Event|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
433836|NCT00565461|E2|Reported Event|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
434093|NCT00566930|B2|Baseline|Spinal Manipulation|spinal manipulation
434094|NCT00566930|B1|Baseline|Control|control group with no treatment only regular assessment appointments
433837|NCT00565461|E1|Reported Event|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
433838|NCT00565604|B1|Baseline|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
433839|NCT00565604|P1|Participant Flow|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
433840|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
433841|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
433842|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
433843|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
433844|NCT00565604|E1|Reported Event|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
433845|NCT00565643|B3|Baseline|Total|Total of all reporting groups
433846|NCT00565643|B2|Baseline|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
433847|NCT00565643|B1|Baseline|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
433848|NCT00565643|P2|Participant Flow|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
433849|NCT00565643|P1|Participant Flow|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
433850|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
433851|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
433852|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
433853|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
433854|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
433855|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
433856|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
433857|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
433858|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
433859|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
433860|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
433861|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
433862|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
433863|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
433864|NCT00565643|E2|Reported Event|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
433865|NCT00565643|E1|Reported Event|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
433866|NCT00566020|B1|Baseline|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433867|NCT00566020|P2|Participant Flow|Lamotrigine - Long-term Administration Phase|Lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433868|NCT00566020|P1|Participant Flow|Lamotrigine - Dosage Adjustment Phase|Lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation
433869|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433870|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
434095|NCT00566930|P3|Participant Flow|Spinal Manipulation and Exercises|Spinal manipulation + exercises
433871|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433872|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433873|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433874|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433875|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433876|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433877|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433878|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433879|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433880|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433881|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433882|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433883|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433884|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433885|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433886|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433887|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433888|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433889|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
434096|NCT00566930|P2|Participant Flow|Spinal Manipulation|spinal manipulation
433890|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433891|NCT00566020|E1|Reported Event|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
433892|NCT00566111|B3|Baseline|Total|Total of all reporting groups
433893|NCT00566111|B2|Baseline|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
433894|NCT00566111|B1|Baseline|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
433895|NCT00566111|P2|Participant Flow|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
433896|NCT00566111|P1|Participant Flow|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
433897|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
433898|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
433899|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
433900|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
433901|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
433902|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
433903|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
433904|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
433905|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
433906|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
433907|NCT00566111|E2|Reported Event|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
433908|NCT00566111|E1|Reported Event|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
433909|NCT00566150|B3|Baseline|Total|Total of all reporting groups
433910|NCT00566150|B2|Baseline|Placebo|Subjects assigned to placebo control group.
433911|NCT00566150|B1|Baseline|Levetiracetam|Subjects on active study medication.
433912|NCT00566150|P2|Participant Flow|Placebo|Subjects assigned to placebo control group.
433913|NCT00566150|P1|Participant Flow|Levetiracetam|Subjects on active study medication.
433914|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
433915|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
433916|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
433917|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
433918|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
433919|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
433920|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
433921|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
433922|NCT00566150|E2|Reported Event|Placebo|Subjects assigned to placebo control group.
433923|NCT00566150|E1|Reported Event|Levetiracetam|Subjects on active study medication.
433924|NCT00566254|B3|Baseline|Total|Total of all reporting groups
433925|NCT00566254|B2|Baseline|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433926|NCT00566254|B1|Baseline|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433927|NCT00566254|P2|Participant Flow|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433928|NCT00566254|P1|Participant Flow|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433929|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433930|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433931|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433932|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433933|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433934|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433935|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433936|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433937|NCT00566254|E2|Reported Event|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433938|NCT00566254|E1|Reported Event|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
433939|NCT00566462|B3|Baseline|Total|Total of all reporting groups
433940|NCT00566462|B2|Baseline|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
433941|NCT00566462|B1|Baseline|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
433942|NCT00566462|P2|Participant Flow|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
433943|NCT00566462|P1|Participant Flow|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
433944|NCT00566462|O2|Outcome|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
433945|NCT00566462|O1|Outcome|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
433946|NCT00566462|O2|Outcome|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
433947|NCT00566462|O1|Outcome|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
433948|NCT00566462|E2|Reported Event|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
433949|NCT00566462|E1|Reported Event|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
433950|NCT00566501|B3|Baseline|Total|Total of all reporting groups
433951|NCT00566501|B2|Baseline|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
433952|NCT00566501|B1|Baseline|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
433953|NCT00566501|P2|Participant Flow|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
433954|NCT00566501|P1|Participant Flow|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
433955|NCT00566501|O2|Outcome|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
433956|NCT00566501|O1|Outcome|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
434097|NCT00566930|P1|Participant Flow|Control|control group with no treatment only regular assessment appointments
434098|NCT00566930|O3|Outcome|Spinal Manipulation and Exercises|Spinal manipulation + exercises
433957|NCT00566501|E2|Reported Event|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
433958|NCT00566501|E1|Reported Event|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
433959|NCT00566579|B3|Baseline|Total|Total of all reporting groups
433960|NCT00566579|B2|Baseline|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
433961|NCT00566579|B1|Baseline|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
433962|NCT00566579|P2|Participant Flow|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
433963|NCT00566579|P1|Participant Flow|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
433964|NCT00566579|O2|Outcome|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
433965|NCT00566579|O1|Outcome|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
433966|NCT00566579|E2|Reported Event|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
433967|NCT00566579|E1|Reported Event|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
433968|NCT00566631|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433969|NCT00566631|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433970|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433971|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433972|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433973|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433974|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433975|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433976|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433977|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433978|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433979|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433980|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433981|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
434099|NCT00566930|O2|Outcome|Spinal Manipulation|spinal manipulation
434100|NCT00566930|O1|Outcome|Control|control group with no treatment only regular assessment appointments
433982|NCT00566631|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
433983|NCT00566696|B1|Baseline|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
433984|NCT00566696|P1|Participant Flow|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
433985|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
433986|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
433987|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
433988|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
433989|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
433990|NCT00566696|E1|Reported Event|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
433991|NCT00566709|B3|Baseline|Total|Total of all reporting groups
433992|NCT00566709|B2|Baseline|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
433993|NCT00566709|B1|Baseline|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
433994|NCT00566709|P2|Participant Flow|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
433995|NCT00566709|P1|Participant Flow|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
433996|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
433997|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
433998|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
433999|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
434000|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
434001|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
434002|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
434003|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
434004|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
434005|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
434006|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
434007|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
434008|NCT00566709|E2|Reported Event|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
434009|NCT00566709|E1|Reported Event|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
434010|NCT00566722|B4|Baseline|Total|Total of all reporting groups
434011|NCT00566722|B3|Baseline|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434012|NCT00566722|B2|Baseline|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434013|NCT00566722|B1|Baseline|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434014|NCT00566722|P3|Participant Flow|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434015|NCT00566722|P2|Participant Flow|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434016|NCT00566722|P1|Participant Flow|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434101|NCT00566930|E3|Reported Event|Spinal Manipulation and Exercises|Spinal manipulation + exercises
434102|NCT00566930|E2|Reported Event|Spinal Manipulation|spinal manipulation
434103|NCT00566930|E1|Reported Event|Control|control group with no treatment only regular assessment appointments
434104|NCT00566943|B3|Baseline|Total|Total of all reporting groups
434105|NCT00566943|B2|Baseline|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
434017|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434018|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434019|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434020|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434021|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434022|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434023|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434024|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434025|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434106|NCT00566943|B1|Baseline|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
434107|NCT00566943|P2|Participant Flow|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
434108|NCT00566943|P1|Participant Flow|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
434109|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Arm|PSD Veritas is used as a buttress on stomach and/or GJ anastomosis.
434026|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434027|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434028|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434029|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434030|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434031|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434032|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434033|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434034|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434110|NCT00566943|O1|Outcome|Number of Subjects in Control Arm|control arm where no buttress is used on stomach or GJ anastomosis staple lines
434111|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Arm Linear|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
434112|NCT00566943|O1|Outcome|Number of Subjects in Control Arm|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
434118|NCT00566943|E1|Reported Event|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
434035|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434036|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434037|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434038|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434039|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434040|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434041|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434042|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434043|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434113|NCT00566943|O2|Outcome|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
434114|NCT00566943|O1|Outcome|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
434115|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Group|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
434119|NCT00566969|B4|Baseline|Total|Total of all reporting groups
434044|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434045|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434046|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434047|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|
434048|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|
434049|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|
434050|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434051|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434052|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434053|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434054|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434055|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434116|NCT00566943|O1|Outcome|Number of Subjects in Control Group|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
434117|NCT00566943|E2|Reported Event|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
434056|NCT00566722|E3|Reported Event|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434057|NCT00566722|E2|Reported Event|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
434058|NCT00566722|E1|Reported Event|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
434059|NCT00566735|B3|Baseline|Total|Total of all reporting groups
434060|NCT00566735|B2|Baseline|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
434061|NCT00566735|B1|Baseline|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
434062|NCT00566735|P2|Participant Flow|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
434063|NCT00566735|P1|Participant Flow|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
434064|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
434065|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
434066|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
434067|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
434068|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
434069|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
434070|NCT00566735|E2|Reported Event|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
434071|NCT00566735|E1|Reported Event|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
434072|NCT00566852|B3|Baseline|Total|Total of all reporting groups
434073|NCT00566852|B2|Baseline|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
434074|NCT00566852|B1|Baseline|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
434075|NCT00566852|P2|Participant Flow|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
434076|NCT00566852|P1|Participant Flow|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
434077|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
434078|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
434079|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
434080|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
434081|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
434082|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
434083|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
434084|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
434085|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
434120|NCT00566969|B3|Baseline|Carvedilol 50 mg|"To be compared to placebo and Carvedilol 25 mg
Carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg"
434121|NCT00566969|B2|Baseline|Carvedilol 25 mg|"To be compared to placebo and Carvedilol 50 mg
carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg"
434122|NCT00566969|B1|Baseline|Sugar Pill|"To be compared to active drug
sugar pill: Subjects randomized to placebo, carvedilol 25mg or 50mg"
434123|NCT00566969|P3|Participant Flow|Carvedilol 50 mg|"To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
434124|NCT00566969|P2|Participant Flow|Carvedilol 25 mg|"To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
434125|NCT00566969|P1|Participant Flow|Sugar Pill|"To be compared to active drug
sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
434126|NCT00566969|O3|Outcome|Carvedilol 50 mg|"To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
434127|NCT00566969|O2|Outcome|Carvedilol 25 mg|"To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
434128|NCT00566969|O1|Outcome|Sugar Pill|"To be compared to active drug
sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
434129|NCT00566969|E3|Reported Event|Carvedilol 50 mg|"To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
434130|NCT00566969|E2|Reported Event|Carvedilol 25 mg|"To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
434131|NCT00566969|E1|Reported Event|Sugar Pill|"To be compared to active drug
sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
434132|NCT00566982|B3|Baseline|Total|Total of all reporting groups
434133|NCT00566982|B2|Baseline|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434134|NCT00566982|B1|Baseline|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434135|NCT00566982|P2|Participant Flow|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434136|NCT00566982|P1|Participant Flow|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434137|NCT00566982|O4|Outcome|Subjects on Ospemifene 60 mg/Day (Week 52)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434138|NCT00566982|O3|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434139|NCT00566982|O2|Outcome|Subjects on Placebo (Week 52)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434140|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434141|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434142|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434143|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434144|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434145|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434146|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434147|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434148|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434149|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434150|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434151|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434152|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434153|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434154|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434155|NCT00566982|E2|Reported Event|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
434156|NCT00566982|E1|Reported Event|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
434157|NCT00566995|B1|Baseline|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
434158|NCT00566995|P1|Participant Flow|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
434159|NCT00566995|O1|Outcome|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
434160|NCT00566995|O1|Outcome|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
434161|NCT00566995|E1|Reported Event|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
434162|NCT00567008|B3|Baseline|Total|Total of all reporting groups
434163|NCT00567008|B2|Baseline|Placebo|Placebo
434164|NCT00567008|B1|Baseline|Varenicline|Varenicline (Chantix)
434165|NCT00567008|P2|Participant Flow|Placebo|Placebo
434166|NCT00567008|P1|Participant Flow|Varenicline 2mg/Day|Varenicline (Chantix)
434171|NCT00567112|B1|Baseline|All Randomized|Includes the 15 participants who were randomized and started the study in Treatment Period 1 (Baseline) and the 3 additional participants who were subsequently randomized and started the study in Treatment Period 2.
434172|NCT00567112|P3|Participant Flow|Treatment Group BCD|"Period 1: Not Applicable
Period 2: OCT (fasted)
Period 3: OCT (after meal)
Period 4: OCT (before meal)"
434173|NCT00567112|P2|Participant Flow|Treatment Group BACD|"Period 1: OCT (fasted)
Period 2: DFC (fasted)
Period 3: OCT (after meal)
Period 4: OCT (before meal)"
434174|NCT00567112|P1|Participant Flow|Treatment Group ABCD|"Period 1: Dry Filled Capsule (DFC) (fasted)
Period 2: Oral Compressed Tablet (OCT) (fasted)
Period 3: OCT (after meal)
Period 4: OCT (before meal)"
434175|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
434176|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
434177|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
434178|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
434179|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
434180|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
434181|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
434182|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
434183|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
434184|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
434185|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
434186|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
434187|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
434188|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
434189|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
434190|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
434191|NCT00567112|E4|Reported Event|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
434192|NCT00567112|E3|Reported Event|OCT (Before Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered before consumption of a standard breakfast
434193|NCT00567112|E2|Reported Event|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
434194|NCT00567112|E1|Reported Event|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
434195|NCT00567164|B4|Baseline|Total|Total of all reporting groups
434196|NCT00567164|B3|Baseline|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434197|NCT00567164|B2|Baseline|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434198|NCT00567164|B1|Baseline|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434199|NCT00567164|P3|Participant Flow|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434200|NCT00567164|P2|Participant Flow|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434276|NCT00567190|P1|Participant Flow|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434277|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
439675|NCT00577135|E2|Reported Event|Continuous Infusion|
434201|NCT00567164|P1|Participant Flow|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434202|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434203|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434204|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434205|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434206|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434207|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434208|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434209|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434210|NCT00567164|O1|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434211|NCT00567164|O2|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434212|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434213|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434214|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434215|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434216|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434217|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434218|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434219|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434220|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434221|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434222|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434223|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434224|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434225|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434278|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434516|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434226|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434227|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434228|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434229|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434230|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434231|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434232|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434233|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434234|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434235|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434236|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434237|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434279|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434307|NCT00567242|E2|Reported Event|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
434238|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434239|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434240|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434241|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434242|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434243|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434244|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434245|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434246|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434247|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434248|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434249|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434280|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434370|NCT00567268|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
434250|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434251|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434252|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434253|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434254|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434255|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434256|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434257|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434258|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434259|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434260|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434261|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434281|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434371|NCT00567268|O3|Outcome|Unknown|Participants with unknown frequency of baseline episodes who responded to the treatment with gabapentin
434262|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434263|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434264|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434265|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434266|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434267|NCT00567164|O2|Outcome|Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2|Pooled FAS of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) (see first arm) and Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300). Regimen no. 2: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434268|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434269|NCT00567164|E3|Reported Event|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
434270|NCT00567164|E2|Reported Event|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
434271|NCT00567164|E1|Reported Event|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
434272|NCT00567190|B3|Baseline|Total|Total of all reporting groups
434273|NCT00567190|B2|Baseline|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434274|NCT00567190|B1|Baseline|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434275|NCT00567190|P2|Participant Flow|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434372|NCT00567268|O2|Outcome|>8 Episodes|Participants with baseline episodes of epileptic seizure more than 8 who responded to the treatment with gabapentin
434282|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434283|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434284|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434285|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434286|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434287|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434288|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434289|NCT00567190|E3|Reported Event|Crossover From Placebo to Pertuzumab|Forty-eight of 406 patients (11.8%) randomized to the placebo treatment group whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2012. Patients received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w until investigator-assessed radiographic or clinical evidence of PD, unacceptable toxicity, or withdrawal of consent. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol.
434290|NCT00567190|E2|Reported Event|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
434291|NCT00567190|E1|Reported Event|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles. For the 48 patients that crossed over to the pertuzumab treatment group, AEs were analyzed from the day of their first placebo dose (Day 1) through the day just prior to their first pertuzumab dose. Any AEs occurring on, or after, the day of their first dose of pertuzumab were included in the Crossover treatment group analysis.
434292|NCT00567229|B1|Baseline|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
434293|NCT00567229|P1|Participant Flow|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
434294|NCT00567229|O1|Outcome|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
434295|NCT00567229|E1|Reported Event|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
434296|NCT00567242|B3|Baseline|Total|Total of all reporting groups
434297|NCT00567242|B2|Baseline|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
434298|NCT00567242|B1|Baseline|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
434299|NCT00567242|P2|Participant Flow|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
434300|NCT00567242|P1|Participant Flow|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
434301|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
434302|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
434303|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
434304|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
434305|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
434306|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
434308|NCT00567242|E1|Reported Event|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
434309|NCT00567255|B3|Baseline|Total|Total of all reporting groups
434310|NCT00567255|B2|Baseline|Placebo|Placebo
434311|NCT00567255|B1|Baseline|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434312|NCT00567255|P2|Participant Flow|Placebo|Placebo
434313|NCT00567255|P1|Participant Flow|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434314|NCT00567255|O2|Outcome|Placebo|Placebo
434315|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434316|NCT00567255|O2|Outcome|Placebo|Placebo
434317|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434318|NCT00567255|O2|Outcome|Placebo|Placebo
434319|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434320|NCT00567255|O2|Outcome|Placebo|Placebo
434321|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434322|NCT00567255|O2|Outcome|Placebo|Placebo
434323|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434324|NCT00567255|O2|Outcome|Placebo|Placebo
434325|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434326|NCT00567255|O2|Outcome|Placebo|Placebo
434327|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434328|NCT00567255|O2|Outcome|Placebo|Placebo
434329|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434330|NCT00567255|O2|Outcome|Placebo|Placebo
434331|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434332|NCT00567255|O2|Outcome|Placebo|Placebo
434333|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434334|NCT00567255|O2|Outcome|Placebo|Placebo
434335|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434336|NCT00567255|O2|Outcome|Placebo|Placebo
434337|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434338|NCT00567255|O2|Outcome|Placebo|Placebo
434339|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434340|NCT00567255|O2|Outcome|Placebo|Placebo
434341|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434342|NCT00567255|O2|Outcome|Placebo|Placebo
434343|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434344|NCT00567255|O2|Outcome|Placebo|Placebo
434345|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434346|NCT00567255|O2|Outcome|Placebo|Placebo
434347|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434348|NCT00567255|O2|Outcome|Placebo|Placebo
434349|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434350|NCT00567255|O2|Outcome|Placebo|Placebo
434351|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434352|NCT00567255|O2|Outcome|Placebo|Placebo
434353|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
434354|NCT00567255|E2|Reported Event|Placebo|Placebo
434355|NCT00567255|E1|Reported Event|NB32/48|"Naltrexone SR 32 mg/bupropion SR 360 mg/day or naltrexone SR 48 mg/bupropion SR 360 mg/day
Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).
NB32/48 group includes all participants in the safety analysis set randomized to NB32 at baseline, regardless of re-randomization status."
434356|NCT00567268|B1|Baseline|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
434357|NCT00567268|P1|Participant Flow|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
434358|NCT00567268|O2|Outcome|Absence of Non-Drug Therapy|Participants without non-drug therapy who responded to treatment with gabapentin
434359|NCT00567268|O1|Outcome|Presence of Non-Drug Therapy|Participants with non-drug therapy who responded to treatment with gabapentin
434360|NCT00567268|O6|Outcome|Unkown|Participants with unkown baseline creatinine clearance
434361|NCT00567268|O5|Outcome|CLcr <5 mL/Min|Participants with baseline creatinine clearance <5 mL/min
434362|NCT00567268|O4|Outcome|CLcr >=5 and <15 mL/Min|Participants with baseline creatinine clearance >=5 and <15 mL/min
434363|NCT00567268|O3|Outcome|CLcr >=15 and <30 mL/Min|Participants with baseline creatinine clearance >=15 and <30 mL/min
434364|NCT00567268|O2|Outcome|CLcr >=30 and <60 mL/Min|Participants with baseline creatinine clearance >=30 and <60 mL/min
434365|NCT00567268|O1|Outcome|CLcr >=60 mL/Min|Participants with baseline creatinine clearance >=60 mL/min
434366|NCT00567268|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
434367|NCT00567268|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
434368|NCT00567268|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
434369|NCT00567268|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
434373|NCT00567268|O1|Outcome|<=8 Episodes|Participants with baseline episodes of epileptic seizure below 8 who responded to the treatment with gabapentin
434374|NCT00567268|O3|Outcome|Severe|Participants with severe epilepsy who responded to the treatment with gabapentin
434375|NCT00567268|O2|Outcome|Moderate|Participants with moderate epilepsy who responded to the treatment with gabapentin
434376|NCT00567268|O1|Outcome|Mild|Participants with mild epilepsy who responded to the treatment with gabapentin
434377|NCT00567268|O7|Outcome|Age >=65 Years|Participants >=65 years of age who responded to the treatment with gabapentin
434378|NCT00567268|O6|Outcome|Age >=55 and <65 Years|Participants >=55 and <65 years of age who responded to the treatment with gabapentin
434379|NCT00567268|O5|Outcome|Age >=45 and <55 Years|Participants >=45 and <55 years of age who responded to the treatment with gabapentin
434380|NCT00567268|O4|Outcome|Age >=35 and <45 Years|Participants >=35 and <45 years of age who responded to the treatment with gabapentin
434381|NCT00567268|O3|Outcome|Age >=25 and <35 Years|Participants >=25 and <35 years of age who responded to the treatment with gabapentin
434382|NCT00567268|O2|Outcome|Age >=15 and <25 Years|Participants >=15 and <25 years of age who responded to the treatment with gabapentin
434383|NCT00567268|O1|Outcome|Age <15 Years|Participants <15 years of age who responded to the treatment with gabapentin
434384|NCT00567268|O2|Outcome|Age >=65 Years|Participants >=65 years of age who responded to the treatment with gabapentin
434385|NCT00567268|O1|Outcome|Age <65 Years|Participants <65 years of age who responded to the treatment with gabapentin
434386|NCT00567268|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
434387|NCT00567268|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
434388|NCT00567268|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
434389|NCT00567268|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
434390|NCT00567268|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
434391|NCT00567268|O7|Outcome|Age >=65 Years|Participants >=65 years years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
434392|NCT00567268|O6|Outcome|Age >=55 and <65 Years|Participants >=55 and <65 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
434393|NCT00567268|O5|Outcome|Age >=45 and <55 Years|Participants >=45 and <55 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
434394|NCT00567268|O4|Outcome|Age >=35 and <45 Years|Participants >=35 and <45 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
434395|NCT00567268|O3|Outcome|Age >=25 and <35 Years|Participants >=25 and <35 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
434396|NCT00567268|O2|Outcome|Age >=15 and <25 Years|Participants >=15 and <25 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
434397|NCT00567268|O1|Outcome|Age <15 Years|Participants <15 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
434398|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
434399|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
434400|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
434401|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
434402|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
434403|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
434404|NCT00567268|E1|Reported Event|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
434406|NCT00567307|B2|Baseline|Standard Practice Group (Arm B)|"Standard Practice
Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
434407|NCT00567307|B1|Baseline|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide
Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
434408|NCT00567307|P2|Participant Flow|Standard Practice Group (Arm B)|"Standard Practice
Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
434409|NCT00567307|P1|Participant Flow|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide
Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
434410|NCT00567307|O2|Outcome|Standard Practice Group (Arm B)|"Standard Practice
Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
434411|NCT00567307|O1|Outcome|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide
Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
434412|NCT00567307|E2|Reported Event|Standard Practice Group (Arm B)|"Standard Practice
Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
434413|NCT00567307|E1|Reported Event|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide
Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
434414|NCT00567320|B3|Baseline|Total|Total of all reporting groups
434415|NCT00567320|B2|Baseline|Placebo|This is the Placebo condition
434416|NCT00567320|B1|Baseline|Varenicline|Varenicline 2 mg per day.
434417|NCT00567320|P2|Participant Flow|Placebo|This is the Placebo condition
434418|NCT00567320|P1|Participant Flow|Varenicline|Varenicline 2 mg per day.
434419|NCT00567320|O2|Outcome|Placebo|This is the Placebo condition
434420|NCT00567320|O1|Outcome|Varenicline|Varenicline 2 mg per day.
434421|NCT00567320|E2|Reported Event|Placebo|This is the Placebo condition
434422|NCT00567320|E1|Reported Event|Varenicline|Varenicline 2 mg per day.
434423|NCT00567476|B3|Baseline|Total|Total of all reporting groups
434424|NCT00567476|B2|Baseline|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434425|NCT00567476|B1|Baseline|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434426|NCT00567476|P2|Participant Flow|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434427|NCT00567476|P1|Participant Flow|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434428|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434429|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434430|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434444|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434431|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434432|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434433|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434434|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434435|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434436|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434437|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434438|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434439|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434440|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434441|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434442|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434443|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434463|NCT00567502|O7|Outcome|Other (Cytoreductives)-Sodium Phosphate P32|Participants who received other (Cytoreductives)-Sodium Phosphate P32 at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
439676|NCT00577135|E1|Reported Event|Q 12 Hour Bolus|
434445|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434446|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434447|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434448|NCT00567476|E2|Reported Event|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434449|NCT00567476|E1|Reported Event|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
434450|NCT00567502|B5|Baseline|Total|Total of all reporting groups
434451|NCT00567502|B4|Baseline|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
434452|NCT00567502|B3|Baseline|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
434453|NCT00567502|B2|Baseline|XAGRID+Other (Cytoreductives)|Participants who received XAGRID along with Other cytoreductives drugs at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
434454|NCT00567502|B1|Baseline|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
434455|NCT00567502|P4|Participant Flow|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator’s discretion.
434456|NCT00567502|P3|Participant Flow|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
434457|NCT00567502|P2|Participant Flow|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
434458|NCT00567502|P1|Participant Flow|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion
434459|NCT00567502|O2|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years. Other Cytoreductives included Hydroxyurea, Interferonalpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
434460|NCT00567502|O1|Outcome|XAGRID|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
434461|NCT00567502|O9|Outcome|Other|Participants who received other therapies at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
434462|NCT00567502|O8|Outcome|Other (Cytoreductives)-Thromboreductin|Participants who received other (Cytoreductives)-Thromboreductin at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
434517|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434464|NCT00567502|O6|Outcome|Other (Cytoreductives)-Pipobroman|Participants who received other (Cytoreductives)-Pipobroman at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
434465|NCT00567502|O5|Outcome|Other (Cytoreductives)-Busulphan|Participants who received other (Cytoreductives)-Busulphan at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
434466|NCT00567502|O4|Outcome|Other (Cytoreductives)-Pegylated Interferon|Participants who received other (Cytoreductives)-Pegylated Interferon at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
434467|NCT00567502|O3|Outcome|Other (Cytoreductives)-Interferon Alpha|Participants who received other (Cytoreductives)-Interferon Alpha at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
434468|NCT00567502|O2|Outcome|Other (Cytoreductives)-Hydroxyurea|Participants who received other (Cytoreductives)-Hydroxyurea at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
434469|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
434470|NCT00567502|O9|Outcome|Other|Participants who received other therapies at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
434471|NCT00567502|O8|Outcome|Other (Cytoreductives)-Thromboreductin|Participants who received other (Cytoreductives)-Thromboreductin at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
434472|NCT00567502|O7|Outcome|Other (Cytoreductives)-Sodium Phosphate P32|Participants who received other (Cytoreductives)-Sodium Phosphate P32 at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
434473|NCT00567502|O6|Outcome|Other (Cytoreductives)-Pipobroman|Participants who received other (Cytoreductives)-Pipobroman at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
434474|NCT00567502|O5|Outcome|Other (Cytoreductives)-Busulphan|Participants who received other (Cytoreductives)-Busulphan at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
434475|NCT00567502|O4|Outcome|Other (Cytoreductives)-Pegylated Interferon|Participants who received other (Cytoreductives)-Pegylated Interferon at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
434476|NCT00567502|O3|Outcome|Other (Cytoreductives)-Interferon Alpha|Participants who received other (Cytoreductives)-Interferon Alpha at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
434477|NCT00567502|O2|Outcome|Other (Cytoreductives)-Hydroxyurea|Participants who received other (Cytoreductives)-Hydroxyurea at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
434478|NCT00567502|O1|Outcome|XAGRID Taken|"Participants who received XAGRID from Xagrid only or Xagrid+other (cytoreductives) arm groups at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period."
434479|NCT00567502|O4|Outcome|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
434480|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
434481|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
434482|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
434483|NCT00567502|O4|Outcome|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
434484|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
434485|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
434486|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
434514|NCT00567567|O3|Outcome|Not Assigned|Patients that either failed during Induction therapy or refused randomization
434515|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
442732|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
434487|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
434488|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
434489|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
434490|NCT00567502|E2|Reported Event|Other (Cytoreductives)|"Participants who received other (cytoreductives) from  other (cytoreductives or Xagrid+other (cytoreductives) arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."
434491|NCT00567502|E1|Reported Event|XAGRID|"Participants who received XAGRID from Xagrid only or Xagrid+other (cytoreductives) arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period."
434492|NCT00567541|B3|Baseline|Total|Total of all reporting groups
434493|NCT00567541|B2|Baseline|Sham BBPM Stimulation|Sham Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation.
434494|NCT00567541|B1|Baseline|Active BBPM Stimulation|Active Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
434495|NCT00567541|P2|Participant Flow|Sham BBPM Stimulation|"The Battery Powered Microneuromodulator(BBPM) will be programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, they will be reprogrammed to receive therapeutic stimulation.
Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation."
434496|NCT00567541|P1|Participant Flow|Active BBPM Stimulation|"The Battery Powered Microneuromodulator (BBPM) is programmed to deliver set therapeutic stimulation parameters for the first 12 weeks of the study.
Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) will be programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation. therapeutic treatment."
434497|NCT00567541|O2|Outcome|Sham BBPM Stimulation|The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
434498|NCT00567541|O1|Outcome|Active BBPM Stimulation|The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
434499|NCT00567541|E2|Reported Event|Sham BBPM Stimulation|The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
434500|NCT00567541|E1|Reported Event|Active BBPM Stimulation|The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
434501|NCT00567567|B4|Baseline|Total|Total of all reporting groups
434502|NCT00567567|B3|Baseline|Not Assigned|Patients that either failed during Induction therapy or refused randomization
434503|NCT00567567|B2|Baseline|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
434504|NCT00567567|B1|Baseline|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434505|NCT00567567|P3|Participant Flow|Not Assigned|Patients that either failed during Induction therapy or refused randomization
434506|NCT00567567|P2|Participant Flow|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
434507|NCT00567567|P1|Participant Flow|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434508|NCT00567567|O3|Outcome|Not Assigned|Patients that either failed during Induction therapy or refused randomization
434509|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
434510|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434511|NCT00567567|O3|Outcome|Not Assigned|Patients that either failed during Induction therapy or refused randomization
434512|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
434513|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434518|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
434519|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434520|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434521|NCT00567567|O3|Outcome|Not Assigned|Patients that either failed during Induction therapy or refused randomization
434522|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
434523|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434524|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434525|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
434526|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434527|NCT00567567|E3|Reported Event|Not Assigned|Patients that either failed during Induction therapy or refused randomization
434528|NCT00567567|E2|Reported Event|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
434529|NCT00567567|E1|Reported Event|Single HST (CEM)|Induction therapy + single myeloablative consolidation
434530|NCT00567593|B1|Baseline|Rosaglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
434531|NCT00567593|P1|Participant Flow|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
434532|NCT00567593|O1|Outcome|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
434533|NCT00567593|E1|Reported Event|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
434534|NCT00567840|B6|Baseline|Total|Total of all reporting groups
434535|NCT00567840|B5|Baseline|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
434536|NCT00567840|B4|Baseline|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
434537|NCT00567840|B3|Baseline|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
434538|NCT00567840|B2|Baseline|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
434539|NCT00567840|B1|Baseline|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
434540|NCT00567840|P5|Participant Flow|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
434541|NCT00567840|P4|Participant Flow|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
434542|NCT00567840|P3|Participant Flow|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
434543|NCT00567840|P2|Participant Flow|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
434544|NCT00567840|P1|Participant Flow|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
434545|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
434546|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
434547|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
434548|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
434549|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
434550|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
434551|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
434552|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
434553|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
434554|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
434555|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
434556|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
434557|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
434558|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
434559|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
434560|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
434561|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
434562|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
434563|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
434564|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
434565|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
434566|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
434567|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
434568|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
434569|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
434570|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
434571|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
434572|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
434573|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
434574|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
434575|NCT00567840|E5|Reported Event|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
434576|NCT00567840|E4|Reported Event|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
434577|NCT00567840|E3|Reported Event|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
434578|NCT00567840|E2|Reported Event|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
434579|NCT00567840|E1|Reported Event|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
434580|NCT00567879|B7|Baseline|Total|Total of all reporting groups
434581|NCT00567879|B6|Baseline|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
442733|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
434582|NCT00567879|B5|Baseline|Oral Arm - Schedule B 15mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
434583|NCT00567879|B4|Baseline|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
434584|NCT00567879|B3|Baseline|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434585|NCT00567879|B2|Baseline|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434586|NCT00567879|B1|Baseline|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434587|NCT00567879|P6|Participant Flow|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
434588|NCT00567879|P5|Participant Flow|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
434589|NCT00567879|P4|Participant Flow|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
434590|NCT00567879|P3|Participant Flow|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434591|NCT00567879|P2|Participant Flow|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434592|NCT00567879|P1|Participant Flow|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434593|NCT00567879|O6|Outcome|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
434594|NCT00567879|O5|Outcome|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
434595|NCT00567879|O4|Outcome|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
434596|NCT00567879|O3|Outcome|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434597|NCT00567879|O2|Outcome|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434598|NCT00567879|O1|Outcome|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434599|NCT00567879|O7|Outcome|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
434600|NCT00567879|O6|Outcome|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
434601|NCT00567879|O5|Outcome|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
434602|NCT00567879|O4|Outcome|Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434603|NCT00567879|O3|Outcome|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434604|NCT00567879|O2|Outcome|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434605|NCT00567879|O1|Outcome|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434606|NCT00567879|E6|Reported Event|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
434607|NCT00567879|E5|Reported Event|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
434608|NCT00567879|E4|Reported Event|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
434609|NCT00567879|E3|Reported Event|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434610|NCT00567879|E2|Reported Event|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434611|NCT00567879|E1|Reported Event|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
434612|NCT00567892|B3|Baseline|Total|Total of all reporting groups
434613|NCT00567892|B2|Baseline|4 Week Treatment|Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks
434614|NCT00567892|B1|Baseline|2 Week Treatment|Treatment (either active rTMS or sham)for 2 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 2 weeks
434615|NCT00567892|P4|Participant Flow|Sham Then Active rTMS Treatment (4 Weeks)|Sham treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks Active rTMS Treatment. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
434616|NCT00567892|P3|Participant Flow|Active Then Sham rTMS Treatment (4 Weeks)|Active rTMS Treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks sham.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.One subject had a drop of THI larger than 20 points from baseline after first arm of treatment and did not get the second arm.
434617|NCT00567892|P2|Participant Flow|Sham Then Active rTMS Treatment (2 Weeks)|Sham treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks Active rTMS Treatment.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
434661|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
442734|NCT00594425|O3|Outcome|Vehicle PDT|
434618|NCT00567892|P1|Participant Flow|Active Then Sham rTMS Treatment (2 Weeks)|Active rTMS Treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks sham. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
434619|NCT00567892|O4|Outcome|4-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 4 weeks.
434620|NCT00567892|O3|Outcome|4-Weeks Active rTMSTreatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 4 weeks.
434621|NCT00567892|O2|Outcome|2-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 2 weeks).
434622|NCT00567892|O1|Outcome|2-Weeks Active rTMSTreatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold)
434623|NCT00567892|O4|Outcome|4-weeks rTMS Sham Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 4 weeks.
434624|NCT00567892|O3|Outcome|4-weeks rTMS Active Treatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 4 weeks.
434625|NCT00567892|O2|Outcome|2-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 2 weeks.
434626|NCT00567892|O1|Outcome|2-weeks rTMS Active Treatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 2 weeks.
434627|NCT00567892|E2|Reported Event|Four Week Treatment|Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks
434628|NCT00567892|E1|Reported Event|2 Weeks Treatment|Treatment (either active rTMS or sham) for two weeks followed by 2 weeks wash-out then treatment (opposite of first assignment)for two weeks
434629|NCT00567996|B4|Baseline|Total|Total of all reporting groups
434630|NCT00567996|B3|Baseline|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434631|NCT00567996|B2|Baseline|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434632|NCT00567996|B1|Baseline|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434633|NCT00567996|P3|Participant Flow|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434634|NCT00567996|P2|Participant Flow|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434635|NCT00567996|P1|Participant Flow|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434636|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434637|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434638|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434639|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434640|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434641|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434642|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434643|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434644|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434645|NCT00567996|E3|Reported Event|Placebo|Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434646|NCT00567996|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434647|NCT00567996|E1|Reported Event|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
434648|NCT00568022|B4|Baseline|Total|Total of all reporting groups
434649|NCT00568022|B3|Baseline|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434650|NCT00568022|B2|Baseline|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434651|NCT00568022|B1|Baseline|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434652|NCT00568022|P3|Participant Flow|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|After receiving Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434653|NCT00568022|P2|Participant Flow|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|After receiving Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434654|NCT00568022|P1|Participant Flow|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434655|NCT00568022|O1|Outcome|All Participants With Measurable Disease and Tumor Response|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥ 1 dose of ixabepilone and/or capecitabine in Cycle 1, completed adequate safety evaluations, and was observed for ≥ 21 days following the first dose or the participant experienced DLT.
434656|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434657|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434658|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434659|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434660|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434693|NCT00568087|B2|Baseline|Placebo|Identical placebo daily for 8 weeks
434662|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434663|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434664|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434665|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434666|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434667|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434668|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434669|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434670|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434671|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434672|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434673|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434674|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434675|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434676|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434677|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434678|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434679|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434680|NCT00568022|E3|Reported Event|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434681|NCT00568022|E2|Reported Event|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
434682|NCT00568022|E1|Reported Event|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each treatment cycle.
434683|NCT00568061|B3|Baseline|Total|Total of all reporting groups
434684|NCT00568061|B2|Baseline|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
434685|NCT00568061|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
434686|NCT00568061|P2|Participant Flow|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
434687|NCT00568061|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
434688|NCT00568061|O2|Outcome|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
434689|NCT00568061|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
434690|NCT00568061|E2|Reported Event|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
434691|NCT00568061|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
434692|NCT00568087|B3|Baseline|Total|Total of all reporting groups
434694|NCT00568087|B1|Baseline|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
434695|NCT00568087|P2|Participant Flow|Placebo|Identical placebo daily for 8 weeks
434696|NCT00568087|P1|Participant Flow|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
434697|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
434698|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
434699|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
434700|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
434701|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
434702|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
434703|NCT00568087|E2|Reported Event|Placebo|Identical placebo daily for 8 weeks
434704|NCT00568087|E1|Reported Event|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
434705|NCT00568178|B3|Baseline|Total|Total of all reporting groups
434706|NCT00568178|B2|Baseline|Amlodipine/Placebo|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan. Hypertensive patients randomized to amlodipine and losartan placebo.
Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.
Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
434707|NCT00568178|B1|Baseline|Losartan|"Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo).
Losartan group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo.
Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.
Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
434708|NCT00568178|P6|Participant Flow|Enalapril Open Label Extension|"Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril.
Dosing of study medication during the extension phase of the study was at the investigator’s discretion.
Enalapril 2.5-, 5-, 10-, and 20-mg tablets were available for participants able to swallow tablets. For participants unable to swallow tablets, or who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared."
434709|NCT00568178|P5|Participant Flow|Losartan Open Label Extension|"Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril.
Dosing of study medication during the extension phase of the study was at the investigator’s discretion.
Losartan 25-mg and 50-mg tablets were available for patients able to swallow tablets. For patients unable to swallow tablets, or who weighed <25 kg, losartan suspension (2.5 mg/ml) was prepared."
434710|NCT00568178|P4|Participant Flow|Amlodipine Double Blind Hypertensive|"Hypertensive patients who were randomized to receive amlodipine and losartan placebo for 12 weeks.
Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.
Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.
Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
434711|NCT00568178|P3|Participant Flow|Losartan Double Blind Hypertensive|"Hypertensive patients who were randomized to receive losartan and amlodipine placebo for 12 weeks.
Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.
Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
434712|NCT00568178|P2|Participant Flow|Placebo Double Blind Normotensive|"Normotensive participants who were randomized to losartan placebo.
Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.
Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.
Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
434713|NCT00568178|P1|Participant Flow|Losartan Double Blind Normortensive|"Normotensive participants who were randomized to losartan.
Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.
Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks; or losartan placebo."
434714|NCT00568178|O2|Outcome|Enalapril Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension and were randomly assigned using a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All patients who entered the extension continued until the 100th patient completed approximately 3 years of follow-up.
435047|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
434715|NCT00568178|O1|Outcome|Losartan Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension and were randomly assigned using a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All patients who entered the extension continued until the 100th patient completed approximately 3 years of follow-up.
434716|NCT00568178|O2|Outcome|Enalapril Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension. Participants were randomized in a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All participants who entered the extension could continue until the 100th participant completed approximately 3 years of follow-up.
434717|NCT00568178|O1|Outcome|Losartan Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension. Participants were randomized in a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All participants who entered the extension could continue until the 100th participant completed approximately 3 years of follow-up.
434718|NCT00568178|O2|Outcome|Amlodipine-Hypertensive Participants|Group includes hypertensive participants who were randomized to amlodipine and losartan placebo.
434719|NCT00568178|O1|Outcome|Losartan-Hypertensive Participants|Group includes hypertensive participants who were randomized to losartan and amlodipine placebo.
434720|NCT00568178|O2|Outcome|Amlodipine-Hypertensive Participants|Group includes hypertensive participants who were randomized to amlodipine and losartan placebo.
434721|NCT00568178|O1|Outcome|Losartan-Hypertensive Participants|Group includes hypertensive participants who were randomized to losartan and amlodipine placebo.
434722|NCT00568178|O2|Outcome|Amlodipine/Placebo|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan placebo. Hypertensive patients randomized to amlodipine and losartan placebo.
Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.
Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
434723|NCT00568178|O1|Outcome|Losartan|Participants were randomized in a 1:1 ratio within each stratum: hypertensive patients (6 to 17 years of age) were randomized to either amlodipine or losartan; normotensive patients (1 to 17 years of age) were randomized to either placebo or losartan. Losartan (or placebo) therapy was administered orally, in tablet or suspension form, at an initial dose of approximately 0.7 mg/kg once daily (up to 50 or 100 mg total daily dose, weight-dependent). Participants who were randomized to losartan were assigned to a normotensive or hypertensive group, based on clinical profile.
434724|NCT00568178|E4|Reported Event|Enalapril: Open-Label Extension|"Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment.
Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum specified dose of enalapril was 40 mg/day. For participants unable to swallow tablets, or for those who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared. The starting dose of drug and any adjustments during the open-label period were at the discretion of the investigator."
434725|NCT00568178|E3|Reported Event|Losartan Open-Label Extension|"Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment.
Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum dose of losartan was 50 mg/day (if the participant weighed <50 kg) or 100 mg/day (if the participant weighed ≥50 kg) Losartan 25-mg and 50-mg tablets were available for participants able to swallow tablets, and losartan suspension (2.5 mg/ml) was prepared for participants unable to swallow tablets, or for those who weighed <25 kg."
434726|NCT00568178|E2|Reported Event|Amlodipine/Placebo: Double-Blind Base Study|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan placebo. Hypertensive patients randomized to amlodipine and losartan placebo.
Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.
Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
434727|NCT00568178|E1|Reported Event|Losartan: Double-Blind Base Study|"Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo).
Losartan group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo.
Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.
Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
434728|NCT00568334|B3|Baseline|Total|Total of all reporting groups
434729|NCT00568334|B2|Baseline|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
435048|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
434730|NCT00568334|B1|Baseline|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434731|NCT00568334|P2|Participant Flow|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434732|NCT00568334|P1|Participant Flow|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434733|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434734|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434735|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434736|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434737|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434738|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434739|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434740|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434741|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434742|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434743|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434744|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434745|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434746|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434747|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434748|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434749|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434750|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434751|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434752|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
435049|NCT00562484|E2|Reported Event|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
434753|NCT00568334|E2|Reported Event|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434754|NCT00568334|E1|Reported Event|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
434755|NCT00568386|B3|Baseline|Total|Total of all reporting groups
434756|NCT00568386|B2|Baseline|Optive Drops Then Systane Drops|Optive Drops then Systane Drops
434757|NCT00568386|B1|Baseline|Systane Drops Then Optive Drops|Systane Drops then Optive Drops
434758|NCT00568386|P2|Participant Flow|Optive Drops Then Systane Drops|Optive Drops then Systane Drops
434759|NCT00568386|P1|Participant Flow|Systane Drops Then Optive Drops|Systane Drops then Optive Drops
434760|NCT00568386|O2|Outcome|Optive Lubricant Eye Drops|Optive Lubricant eye drops
434761|NCT00568386|O1|Outcome|Systane Lubricant Eye Drops|Systane lubricant eye drops
434762|NCT00568386|E2|Reported Event|Optive Lubricant Eye Drops|Optive Lubricant eye drops
434763|NCT00568386|E1|Reported Event|Systane Lubricant Eye Drops|Systane lubricant eye drops
434764|NCT00568399|B1|Baseline|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
434765|NCT00568399|P1|Participant Flow|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
434766|NCT00568399|O1|Outcome|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months
434767|NCT00568399|E1|Reported Event|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
434768|NCT00568451|B5|Baseline|Total|Total of all reporting groups
434769|NCT00568451|B4|Baseline|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
434770|NCT00568451|B3|Baseline|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
434771|NCT00568451|B2|Baseline|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
434772|NCT00568451|B1|Baseline|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
434773|NCT00568451|P4|Participant Flow|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
434774|NCT00568451|P3|Participant Flow|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
434775|NCT00568451|P2|Participant Flow|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
434776|NCT00568451|P1|Participant Flow|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
434777|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
434778|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
434779|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
434780|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
434781|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
434782|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
434783|NCT00568451|O4|Outcome|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
434784|NCT00568451|O3|Outcome|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
434785|NCT00568451|O2|Outcome|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
434786|NCT00568451|O1|Outcome|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
434787|NCT00568451|E4|Reported Event|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
434788|NCT00568451|E3|Reported Event|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
434789|NCT00568451|E2|Reported Event|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
434790|NCT00568451|E1|Reported Event|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
434791|NCT00556491|B3|Baseline|Total|Total of all reporting groups
434792|NCT00556491|B2|Baseline|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
434793|NCT00556491|B1|Baseline|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
434794|NCT00556491|P2|Participant Flow|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
434795|NCT00556491|P1|Participant Flow|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
434796|NCT00556491|O2|Outcome|Placebo|
434797|NCT00556491|O1|Outcome|Minocycline|
434798|NCT00556491|E2|Reported Event|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
434799|NCT00556491|E1|Reported Event|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
434800|NCT00556504|B3|Baseline|Total|Total of all reporting groups
434801|NCT00556504|B2|Baseline|Placebo|Placebo with convetional treatment for HCV patients
434802|NCT00556504|B1|Baseline|TCM-700C|TCM-700C, an add-on drug to conventional treatment of Hepatitis C
434803|NCT00556504|P2|Participant Flow|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434869|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434804|NCT00556504|P1|Participant Flow|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434805|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434806|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434807|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434808|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434809|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434810|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434811|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434812|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434813|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434814|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434815|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434816|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434817|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434818|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
434819|NCT00556504|E2|Reported Event|Placebo (Safety Population)|Placebo with convetional treatment(PegIFN plus RBV) for HCV patients
434820|NCT00556504|E1|Reported Event|TCM-700C (Safety Population)|TCM-700C, an add-on drug to conventional treatment(PegIFN plus RBV)of Hepatitis C
434821|NCT00556543|B1|Baseline|All Study Subjects|
434822|NCT00556543|P1|Participant Flow|All Study Subjects|
434823|NCT00556543|O1|Outcome|All Study Subjects|
434824|NCT00556543|O1|Outcome|All Study Subjects|
434825|NCT00556543|O1|Outcome|All Study Subjects|
434826|NCT00556543|O1|Outcome|All Study Subjects|
434827|NCT00556543|O1|Outcome|All Study Subjects|
434828|NCT00556543|O1|Outcome|All Study Subjects|
434829|NCT00556543|O1|Outcome|All Study Subjects|
434830|NCT00556543|O1|Outcome|All Study Subjects|
434831|NCT00556543|O1|Outcome|All Study Subjects|
434832|NCT00556543|O1|Outcome|All Study Subjects|
434833|NCT00556543|O2|Outcome|Rib Fracture Repair for Persistent Rib Fracture Non-Union|Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 – 56 months) post-injury at the time of repair.
434834|NCT00556543|O1|Outcome|Acute Rib Fracture Repair|These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 – 18 days) post-injury.
434835|NCT00556543|E2|Reported Event|Chronic Rib Fracture Non-union Repair|
434836|NCT00556543|E1|Reported Event|Acute Rib Fracture Repair|
434837|NCT00556673|B3|Baseline|Total|Total of all reporting groups
434838|NCT00556673|B2|Baseline|Placebo - Indacaterol/Mometasone|In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
435050|NCT00562484|E1|Reported Event|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
434839|NCT00556673|B1|Baseline|Indacaterol/Mometasone - Placebo|In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
434840|NCT00556673|P2|Participant Flow|Placebo - Indacaterol/Mometasone|In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
434841|NCT00556673|P1|Participant Flow|Indacaterol/Mometasone - Placebo|In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
434842|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434843|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434844|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434845|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434846|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434847|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434848|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434849|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
434850|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
434851|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434852|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
434853|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
434854|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434855|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
434856|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
434857|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434858|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
434859|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
434860|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434861|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
434862|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
434863|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434864|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
434865|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
434866|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434867|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
434868|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
435051|NCT00562588|B3|Baseline|Total|Total of all reporting groups
434870|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
434871|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
434872|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434873|NCT00556673|E3|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
434874|NCT00556673|E2|Reported Event|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
434875|NCT00556673|E1|Reported Event|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
434876|NCT00556712|B3|Baseline|Total|Total of all reporting groups
434877|NCT00556712|B2|Baseline|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434878|NCT00556712|B1|Baseline|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434879|NCT00556712|P2|Participant Flow|Erlotinib, 150 Milligrams Per Day (mg/Day)|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434880|NCT00556712|P1|Participant Flow|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were randomized to receive a placebo, orally (PO) as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434881|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434882|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434883|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434884|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434885|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434886|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434887|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434962|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
435052|NCT00562588|B2|Baseline|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
434888|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434889|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434890|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434891|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434892|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434893|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434894|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434895|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434896|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434897|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434898|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434899|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434900|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434901|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434963|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
435191|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
434902|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434903|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434904|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434905|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434906|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434907|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434908|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434909|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434910|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434911|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434912|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434913|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434914|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434915|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434964|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
442735|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
434916|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434917|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434918|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434919|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434920|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434921|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434922|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434923|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434924|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434925|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434926|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434927|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434928|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434929|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434965|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
442736|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
434930|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434931|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434932|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434933|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434934|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434935|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434936|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434937|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434938|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434939|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434940|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434941|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434942|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434943|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434966|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
442737|NCT00594425|O3|Outcome|Vehicle PDT|
434944|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434945|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434946|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434947|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434948|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434949|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434950|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434951|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434952|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434953|NCT00556712|E2|Reported Event|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434954|NCT00556712|E1|Reported Event|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
434955|NCT00562315|B1|Baseline|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
434956|NCT00562315|P1|Participant Flow|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
434957|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
434958|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
434959|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
434960|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|"This is a single arm study
[18F]FACBC: [18F]FACBC is given intravenously prior to PET scan"
434961|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
435045|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
434967|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
434968|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
434969|NCT00562315|E1|Reported Event|FACBC PET-CT and ProstaScint CT|All participants who received scans, including repeat scans, were monitored for adverse events.
434970|NCT00562328|B1|Baseline|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
434971|NCT00562328|P1|Participant Flow|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
434972|NCT00562328|O1|Outcome|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
434973|NCT00562328|E1|Reported Event|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
434974|NCT00562354|B3|Baseline|Total|Total of all reporting groups
434975|NCT00562354|B2|Baseline|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
434976|NCT00562354|B1|Baseline|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
434977|NCT00562354|P2|Participant Flow|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
434978|NCT00562354|P1|Participant Flow|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
434979|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
434980|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age.
434981|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
434982|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
434983|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age.
434984|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
434985|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
434986|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
434987|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
434988|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
434989|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
434990|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
434991|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
434992|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
434993|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
434994|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
434995|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
434996|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
434997|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
434998|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
434999|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
435000|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
435001|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
435002|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
435003|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
435004|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
435005|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
435046|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435006|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
435007|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
435008|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
435009|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
435010|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
435011|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
435012|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
435013|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
435014|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
435015|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
435016|NCT00562354|E2|Reported Event|13vPnC (≥65 Years of Age)|"13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=77; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=116. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods)."
435017|NCT00562354|E1|Reported Event|13vPnC (50 to 64 Years of Age)|"13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=80; systematic (solicited) Local Reactions N=120; systematic (solicited) Systemic Events N=112. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods)."
435018|NCT00562484|B3|Baseline|Total|Total of all reporting groups
435019|NCT00562484|B2|Baseline|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435020|NCT00562484|B1|Baseline|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435021|NCT00562484|P2|Participant Flow|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435022|NCT00562484|P1|Participant Flow|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435023|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435024|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435025|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435026|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435027|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435028|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435029|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435030|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435031|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435032|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435033|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435034|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435035|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435036|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435037|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435038|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435039|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435040|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435041|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435042|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435043|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
435044|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
435053|NCT00562588|B1|Baseline|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435054|NCT00562588|P2|Participant Flow|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435055|NCT00562588|P1|Participant Flow|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435056|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435057|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435058|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435059|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435060|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435061|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435062|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435063|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435064|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435065|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435066|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435067|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435068|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435069|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435070|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435071|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435072|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435073|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435074|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435075|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435076|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435077|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435078|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435079|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435080|NCT00562588|E2|Reported Event|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435081|NCT00562588|E1|Reported Event|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
435082|NCT00562627|B4|Baseline|Total|Total of all reporting groups
435083|NCT00562627|B3|Baseline|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
435084|NCT00562627|B2|Baseline|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
435085|NCT00562627|B1|Baseline|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
435086|NCT00562627|P3|Participant Flow|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
435087|NCT00562627|P2|Participant Flow|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
435088|NCT00562627|P1|Participant Flow|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
435089|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
435090|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
435091|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
435092|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
435093|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
435094|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
435095|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
435096|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
435097|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
435098|NCT00562627|E3|Reported Event|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
435099|NCT00562627|E2|Reported Event|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
435100|NCT00562627|E1|Reported Event|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
435101|NCT00568555|B3|Baseline|Total|Total of all reporting groups
435102|NCT00568555|B2|Baseline|Placebo - Sugar Pill|
435103|NCT00568555|B1|Baseline|Low Dose Naltrexone|
435104|NCT00568555|P2|Participant Flow|Placebo - Sugar Pill First|Placebo first, followed by LDN. Placebo (sugar pill) once a day. LDN at 3-4.5mg, once a day.
435105|NCT00568555|P1|Participant Flow|Low Dose Naltrexone First|Low Dose Naltrexone (LDN) followed by placebo. LDN at 3-4.5mg, once a day. Placebo (sugar pill) once a day.
435106|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
435107|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
435108|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
435109|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
435110|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participants during the placebo condition
435111|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
435112|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
435113|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
435114|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participants during the placebo condition
435115|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
435116|NCT00568555|E2|Reported Event|Placebo - Sugar Pill|All participants during the placebo condition
435117|NCT00568555|E1|Reported Event|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
435118|NCT00568685|B4|Baseline|Total|Total of all reporting groups
435119|NCT00568685|B3|Baseline|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
435120|NCT00568685|B2|Baseline|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435121|NCT00568685|B1|Baseline|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435122|NCT00568685|P3|Participant Flow|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
435123|NCT00568685|P2|Participant Flow|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435124|NCT00568685|P1|Participant Flow|Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day)|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435125|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
435126|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435127|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435128|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
435129|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435130|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435131|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
435132|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435133|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435134|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
435135|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
442738|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
435136|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435137|NCT00568685|O3|Outcome|>0.85 mg/kg/Day|Patients received atomoxetine >0.85 mg/kg/day
435138|NCT00568685|O2|Outcome|0.36-0.85 mg/kg/Day|Patients received atomoxetine 0.36-0.85 mg/kg/day
435139|NCT00568685|O1|Outcome|0-0.35 mg/kg/Day|Patients received atomoxetine 0-0.35 mg/kg/day
435140|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
435141|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435142|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435143|NCT00568685|O3|Outcome|> 0.85 mg/kg/Day|Patients received atomoxetine >0.85 mg/kg/day
435144|NCT00568685|O2|Outcome|0.36-0.85 mg/kg/Day|Patients received atomoxetine 0.36-0.85 mg/kg/day
435145|NCT00568685|O1|Outcome|0-0.35 mg/kg/Day|Patients received atomoxetine 0-0.35 mg/kg/day
435146|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
435147|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435148|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435149|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
435150|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435151|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
435152|NCT00568685|E3|Reported Event|Atomoxetine >0.85 mg/kg/Day|Patients who received the actual dose range listed.
435153|NCT00568685|E2|Reported Event|Atomoxetine 0.36-0.85 mg/kg/Day|Patients who received the actual dose range listed.
435154|NCT00568685|E1|Reported Event|Atomoxetine 0.00-0.35 mg/kg/Day|Patients who received the actual dose range listed.
435155|NCT00568776|B5|Baseline|Total|Total of all reporting groups
435156|NCT00568776|B4|Baseline|ELND005 2000 mg BID|oral administration for 78 weeks
435157|NCT00568776|B3|Baseline|ELND005 1000 mg BID|oral administration for 78 weeks
435158|NCT00568776|B2|Baseline|ELND005 250 mg BID|oral administration for 78 weeks
435159|NCT00568776|B1|Baseline|Placebo BID|oral administration for 78 weeks
435160|NCT00568776|P4|Participant Flow|ELND005 2000 mg BID|oral administration for 78 weeks
435161|NCT00568776|P3|Participant Flow|ELND005 1000 mg BID|oral administration for 78 weeks
435162|NCT00568776|P2|Participant Flow|ELND005 250 mg BID|oral administration for 78 weeks
435163|NCT00568776|P1|Participant Flow|Placebo BID|oral administration for 78 weeks
435164|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
435165|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
435166|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
435167|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
435168|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
435169|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
435170|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
435171|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
435172|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
435173|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
435174|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
435175|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
435176|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
435177|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
435178|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
435179|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
435180|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
435181|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
435182|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
435183|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
435184|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
435185|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
435186|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
435187|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
435188|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
435189|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
435190|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
435192|NCT00568776|E4|Reported Event|ELND005 2000 mg BID|oral administration for 78 weeks
435193|NCT00568776|E3|Reported Event|ELND005 1000 mg BID|oral administration for 78 weeks
435194|NCT00568776|E2|Reported Event|ELND005 250 mg BID|oral administration for 78 weeks
435195|NCT00568776|E1|Reported Event|Placebo BID|oral administration for 78 weeks
435196|NCT00568854|B3|Baseline|Total|Total of all reporting groups
435197|NCT00568854|B2|Baseline|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
435198|NCT00568854|B1|Baseline|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
435199|NCT00568854|P2|Participant Flow|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
435200|NCT00568854|P1|Participant Flow|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
435201|NCT00568854|O2|Outcome|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
435202|NCT00568854|O1|Outcome|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
435203|NCT00568854|O2|Outcome|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
435204|NCT00568854|O1|Outcome|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
435205|NCT00568854|E2|Reported Event|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
435206|NCT00568854|E1|Reported Event|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
435207|NCT00568958|B3|Baseline|Total|Total of all reporting groups
435208|NCT00568958|B2|Baseline|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
435209|NCT00568958|B1|Baseline|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
435210|NCT00568958|P2|Participant Flow|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
435211|NCT00568958|P1|Participant Flow|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
435212|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
435253|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435213|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
435214|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
435215|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
435216|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
435217|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
435218|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
435219|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
435220|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
435221|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
435222|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
435223|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
435224|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
435252|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435225|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
435226|NCT00568958|E2|Reported Event|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
435227|NCT00568958|E1|Reported Event|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling
BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
435228|NCT00569010|B5|Baseline|Total|Total of all reporting groups
435229|NCT00569010|B4|Baseline|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
435230|NCT00569010|B3|Baseline|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
435231|NCT00569010|B2|Baseline|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
435232|NCT00569010|B1|Baseline|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
435233|NCT00569010|P4|Participant Flow|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
435234|NCT00569010|P3|Participant Flow|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
435235|NCT00569010|P2|Participant Flow|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
435236|NCT00569010|P1|Participant Flow|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
435237|NCT00569010|O4|Outcome|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
435238|NCT00569010|O3|Outcome|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
435239|NCT00569010|O2|Outcome|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
435240|NCT00569010|O1|Outcome|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
435241|NCT00569010|E4|Reported Event|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
435242|NCT00569010|E3|Reported Event|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
435243|NCT00569010|E2|Reported Event|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
435244|NCT00569010|E1|Reported Event|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
435245|NCT00569127|B3|Baseline|Total|Total of all reporting groups
435246|NCT00569127|B2|Baseline|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435247|NCT00569127|B1|Baseline|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435248|NCT00569127|P2|Participant Flow|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435249|NCT00569127|P1|Participant Flow|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435250|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435251|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435254|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435255|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435256|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435257|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435258|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435259|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435260|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435261|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435262|NCT00569127|E2|Reported Event|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435263|NCT00569127|E1|Reported Event|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
435264|NCT00569166|B4|Baseline|Total|Total of all reporting groups
435265|NCT00569166|B3|Baseline|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435266|NCT00569166|B2|Baseline|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435267|NCT00569166|B1|Baseline|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435268|NCT00569166|P3|Participant Flow|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435269|NCT00569166|P2|Participant Flow|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435270|NCT00569166|P1|Participant Flow|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435271|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435272|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435273|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435274|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435275|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435276|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435277|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435278|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435279|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435280|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435281|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435321|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435282|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435283|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435284|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435285|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435286|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435287|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435288|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435289|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435290|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435291|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435292|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435293|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435294|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435295|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435296|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435297|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435298|NCT00569166|E3|Reported Event|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435299|NCT00569166|E2|Reported Event|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435300|NCT00569166|E1|Reported Event|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
435301|NCT00569192|B4|Baseline|Total|Total of all reporting groups
435302|NCT00569192|B3|Baseline|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435303|NCT00569192|B2|Baseline|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435304|NCT00569192|B1|Baseline|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
435305|NCT00569192|P3|Participant Flow|0.25 mg MAP0010|0.125mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435306|NCT00569192|P2|Participant Flow|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435307|NCT00569192|P1|Participant Flow|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
435308|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435309|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435310|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
435311|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435312|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435313|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
435314|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435315|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435316|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
435317|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435318|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435319|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
435320|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435322|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
435323|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435324|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435325|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
435326|NCT00569192|E3|Reported Event|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435327|NCT00569192|E2|Reported Event|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
435328|NCT00569192|E1|Reported Event|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
435329|NCT00569231|B1|Baseline|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
435330|NCT00569231|P1|Participant Flow|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
435331|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
435332|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
435333|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
435334|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
435335|NCT00569231|E1|Reported Event|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
435336|NCT00569270|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and Tiotropium first.
435337|NCT00569270|P2|Participant Flow|Placebo First, Then Tiotropium Bromide 18 µg|tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
435338|NCT00569270|P1|Participant Flow|Tiotropium 18 µg Capsule First, Then Placebo|tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
435339|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and FRC/TLC|Extent of lung CT scored emphysema (percent of lung) and lung function of FRC/TLC (functional residual capacity(L)/total lung capacity (L) after tiotropium
435340|NCT00569270|O2|Outcome|TLC (L) 2h Post Tiotropium|Total Lung Capacity (L)following metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h tiotropium
435341|NCT00569270|O1|Outcome|2h Post Placebo TLC(L)|total lung capacity (L) following metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h placebo
435342|NCT00569270|O2|Outcome|After DH (Dynamic Hyperinflation|IC (inspiratory capacity) before and after metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h placebo
435343|NCT00569270|O1|Outcome|Before DH (Dynamic Hyperinflation)|IC (inspiratory capacity) before and after metronome paced hyperventilation and induced dynamic hyperinflation at baseline;
435344|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
435345|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
435346|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first
435347|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
435348|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
435349|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
435350|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
435351|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
435352|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
435353|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
435354|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
435355|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
435356|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
435357|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
435358|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
435359|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
435360|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
435361|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
435362|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and IC|Extent of lung CT scored emphysema (percent of lung) and lung function of IC (inspiratory capacity, L) after tiotropium.
435363|NCT00569270|O2|Outcome|Tiotropium 18 µg Capsule, Bronchodilator|Includes groups randomized to receive placebo first and Tiotropium first.
435364|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
436138|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
435365|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
435366|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
435367|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and FEV1|Extent of lung CT scored emphysema and and lung function of FEV1(l) after tiotropium
435368|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
435369|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
435370|NCT00569270|E2|Reported Event|Placebo|Adverse events after placebo. (30 enrolled subjects, one drop-out)
435371|NCT00569270|E1|Reported Event|Tiotropium Bromide 18 µg, Capsule,|tiotropium 18 µg capsule for 1 month. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium. (30 enrolled subjects, one drop-out)
435372|NCT00569374|B1|Baseline|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
435373|NCT00569374|P1|Participant Flow|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
435374|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
435375|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
435376|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
435377|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
435378|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
435379|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
435380|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
435381|NCT00569374|E1|Reported Event|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
435382|NCT00569530|B3|Baseline|Total|Total of all reporting groups
435383|NCT00569530|B2|Baseline|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Sham Infants will not receive additional doses of Infasurf."
435384|NCT00569530|B1|Baseline|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
435385|NCT00569530|P2|Participant Flow|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Sham Infants will not receive additional doses of Infasurf."
435386|NCT00569530|P1|Participant Flow|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
435387|NCT00569530|O2|Outcome|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Sham Infants will not receive additional doses of Infasurf."
435388|NCT00569530|O1|Outcome|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
435389|NCT00569530|O2|Outcome|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Sham Infants will not receive additional doses of Infasurf."
435390|NCT00569530|O1|Outcome|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
435391|NCT00569530|E2|Reported Event|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Sham Infants will not receive additional doses of Infasurf."
435392|NCT00569530|E1|Reported Event|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
435393|NCT00569582|B1|Baseline|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
435394|NCT00569582|P1|Participant Flow|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
435395|NCT00569582|O1|Outcome|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
435396|NCT00569582|O1|Outcome|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
435397|NCT00569582|E1|Reported Event|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
435398|NCT00569660|B1|Baseline|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
435399|NCT00569660|P1|Participant Flow|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
435400|NCT00569660|O1|Outcome|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
435401|NCT00569660|E1|Reported Event|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
435402|NCT00569673|B1|Baseline|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
435403|NCT00569673|P1|Participant Flow|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
435499|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
435404|NCT00569673|O1|Outcome|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
435405|NCT00569673|E1|Reported Event|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
435406|NCT00569777|B3|Baseline|Total|Total of all reporting groups
435407|NCT00569777|B2|Baseline|Placebo|etafilcon A contact lens without ketotifen
435408|NCT00569777|B1|Baseline|K-lens|etafilcon A contact lens with ketotifen.
435409|NCT00569777|P2|Participant Flow|Placebo|etafilcon A contact lens without ketotifen
435410|NCT00569777|P1|Participant Flow|K-lens|etafilcon A contact lens with ketotifen.
435411|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435412|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435413|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435414|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435415|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435416|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435417|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435418|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435419|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435420|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435421|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435422|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435423|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435424|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435425|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435426|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435427|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435428|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435429|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435430|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435431|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435432|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435433|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435434|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435435|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435436|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435437|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435438|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435439|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435440|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435441|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435442|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435443|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435444|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435445|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435446|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435447|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
435448|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
435449|NCT00569777|E2|Reported Event|Placebo|etafilcon A contact lens without ketotifen
435450|NCT00569777|E1|Reported Event|K-lens|etafilcon A contact lens with ketotifen.
435451|NCT00569803|B9|Baseline|Total|Total of all reporting groups
435452|NCT00569803|B8|Baseline|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
435453|NCT00569803|B7|Baseline|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435454|NCT00569803|B6|Baseline|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435455|NCT00569803|B5|Baseline|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435456|NCT00569803|B4|Baseline|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435457|NCT00569803|B3|Baseline|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435458|NCT00569803|B2|Baseline|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435459|NCT00569803|B1|Baseline|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435460|NCT00569803|P8|Participant Flow|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
435461|NCT00569803|P7|Participant Flow|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435498|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435624|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
435462|NCT00569803|P6|Participant Flow|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435463|NCT00569803|P5|Participant Flow|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435464|NCT00569803|P4|Participant Flow|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435465|NCT00569803|P3|Participant Flow|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435466|NCT00569803|P2|Participant Flow|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435467|NCT00569803|P1|Participant Flow|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435468|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435469|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435470|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435471|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435472|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435473|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435474|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435475|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
435476|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435477|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435478|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435479|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435480|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435481|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435482|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435483|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
435484|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435485|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435486|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435487|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435488|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435489|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435490|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435491|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
435492|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435493|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435494|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435495|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435496|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435497|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435625|NCT00570037|O1|Outcome|Hospital With Immunization Program|
435500|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435501|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435502|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435503|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435504|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435505|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435506|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435507|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
435508|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435509|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435510|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435511|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435512|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435513|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435514|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435515|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
435516|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435517|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435518|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435519|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435520|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435521|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435522|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435523|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
435524|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435525|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435526|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435527|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435528|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435529|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435530|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435531|NCT00569803|O2|Outcome|2 Injection Sites|Participants receiving treatments of 150mg, 200mg and 250mg Subcutaneous Belatacept were injected at 2 sites; one injection equal to half the total dose was delivered to the anterior thigh on each side.
435532|NCT00569803|O1|Outcome|1 Injection Site|Participants receiving treatments of 50mg, 100mg and 125mg Subcutaneous Belatacept were injected at 1 site at the anterior thigh.
435533|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435534|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435535|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435536|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435537|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435538|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435539|NCT00569803|O1|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435540|NCT00569803|O1|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435541|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435542|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435543|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435544|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435545|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435546|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435547|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435548|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435549|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435550|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435551|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435552|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435553|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435554|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435555|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435556|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435557|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435558|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435559|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435560|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435561|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435562|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435563|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435564|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435565|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435566|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435567|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435568|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435569|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435570|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435571|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435626|NCT00570037|E2|Reported Event|Hospital With No Immunization Program|
435572|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435573|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435574|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435575|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
435576|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435577|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435578|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435579|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435580|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435581|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435582|NCT00569803|E9|Reported Event|All Belatacept|All participants treated with IV or SC Belatacept of any dose
435583|NCT00569803|E8|Reported Event|PLACEBO|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
435584|NCT00569803|E7|Reported Event|Belatacept 125mg IV|125 mg Belatacept intravenous (IV) injection
435585|NCT00569803|E6|Reported Event|Belatacept 250mg SC|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435586|NCT00569803|E5|Reported Event|Belatacept 200mg SC|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435587|NCT00569803|E4|Reported Event|Belatacept 150mg SC|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
435588|NCT00569803|E3|Reported Event|Belatacept 125mg SC|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
435589|NCT00569803|E2|Reported Event|Belatacept 100mg SC|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
435590|NCT00569803|E1|Reported Event|Belatacept 50mg SC|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
435591|NCT00569855|B1|Baseline|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
435592|NCT00569855|P1|Participant Flow|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
435593|NCT00569855|O1|Outcome|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
435594|NCT00569855|E1|Reported Event|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
435595|NCT00569868|B1|Baseline|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
435596|NCT00569868|P1|Participant Flow|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
435597|NCT00569868|O1|Outcome|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
435598|NCT00569868|E1|Reported Event|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
435599|NCT00569946|B1|Baseline|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435600|NCT00569946|P1|Participant Flow|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435601|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435627|NCT00570037|E1|Reported Event|Hospital With Immunization Program|
435628|NCT00570089|B1|Baseline|All Study Participants|Participants who were randomized to receive either Study drug Ranexa or Placebo.
435668|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
435602|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435603|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435604|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435605|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435606|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435607|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435608|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435609|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435610|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435611|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435612|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435613|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435614|NCT00569946|E1|Reported Event|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
435615|NCT00570037|B3|Baseline|Total|Total of all reporting groups
435616|NCT00570037|B2|Baseline|Hospital With No Immunization Program|
435617|NCT00570037|B1|Baseline|Hospital With Immunization Program|
435618|NCT00570037|P2|Participant Flow|Hospital With No Immunization Program|
435619|NCT00570037|P1|Participant Flow|Hospital With Immunization Program|
435620|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
435621|NCT00570037|O1|Outcome|Hospital With Immunization Program|
435622|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
435623|NCT00570037|O1|Outcome|Hospital With Immunization Program|
435629|NCT00570089|P2|Participant Flow|Placebo Then Study Drug Ranexa|20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
435630|NCT00570089|P1|Participant Flow|Study Drug Ranexa Then Placebo|20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
435631|NCT00570089|O2|Outcome|Placebo|Placebo arm
435632|NCT00570089|O1|Outcome|Study Drug|Study drug Ranexa arm
435633|NCT00570089|O2|Outcome|Placebo - CMRs (10 CMR 1 and 10 CMR 2)|CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
435634|NCT00570089|O1|Outcome|Study Drug Ranexa - CMRs (10 CMR 1 and 10 CMR 2)|CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
435635|NCT00570089|E2|Reported Event|Placebo|Placebo arm
435636|NCT00570089|E1|Reported Event|Study Drug|Study drug Ranexa arm
435637|NCT00570141|B1|Baseline|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
435638|NCT00570141|P1|Participant Flow|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
435639|NCT00570141|O1|Outcome|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
435640|NCT00570141|O1|Outcome|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
435641|NCT00570141|E1|Reported Event|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
435642|NCT00570232|B1|Baseline|Tarceva|"All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months"
435643|NCT00570232|P1|Participant Flow|Tarceva|"All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months"
435644|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months"
435645|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months"
435646|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months"
435647|NCT00570232|E1|Reported Event|Tarceva|"All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months"
435648|NCT00570310|B3|Baseline|Total|Total of all reporting groups
435649|NCT00570310|B2|Baseline|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
435650|NCT00570310|B1|Baseline|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
435651|NCT00570310|P2|Participant Flow|Placebo|Patients were treated with placebo starting at randomization.
435652|NCT00570310|P1|Participant Flow|Pregabalin|Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.
435653|NCT00570310|O2|Outcome|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
435654|NCT00570310|O1|Outcome|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
435655|NCT00570310|O2|Outcome|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
435656|NCT00570310|O1|Outcome|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
435657|NCT00570310|E2|Reported Event|Placebo|Patients were treated with placebo starting at randomization.
435658|NCT00570310|E1|Reported Event|Pregabalin|Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.
435659|NCT00570349|B4|Baseline|Total|Total of all reporting groups
435660|NCT00570349|B3|Baseline|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
435661|NCT00570349|B2|Baseline|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
435662|NCT00570349|B1|Baseline|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
435663|NCT00570349|P3|Participant Flow|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
435664|NCT00570349|P2|Participant Flow|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
435665|NCT00570349|P1|Participant Flow|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
435666|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
435667|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
436392|NCT00573131|B3|Baseline|Total|Total of all reporting groups
435669|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
435670|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
435671|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
435672|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
435673|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
435674|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
435675|NCT00570349|E3|Reported Event|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
435676|NCT00570349|E2|Reported Event|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
435677|NCT00570349|E1|Reported Event|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
435678|NCT00570362|B3|Baseline|Total|Total of all reporting groups
435679|NCT00570362|B2|Baseline|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
435680|NCT00570362|B1|Baseline|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
435681|NCT00570362|P2|Participant Flow|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
435682|NCT00570362|P1|Participant Flow|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
435683|NCT00570362|O2|Outcome|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
435684|NCT00570362|O1|Outcome|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
435685|NCT00570362|E2|Reported Event|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
435686|NCT00570362|E1|Reported Event|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
435687|NCT00570401|B1|Baseline|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
435688|NCT00570401|P1|Participant Flow|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
435689|NCT00570401|O1|Outcome|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
435690|NCT00570401|E1|Reported Event|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
435691|NCT00570492|B3|Baseline|Total|Total of all reporting groups
435692|NCT00570492|B2|Baseline|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435693|NCT00570492|B1|Baseline|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435694|NCT00570492|P3|Participant Flow|FFNS 110 mcg: Double-blind Treatment Period|Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
435695|NCT00570492|P2|Participant Flow|Placebo: Double-blind Treatment Period|Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
435696|NCT00570492|P1|Participant Flow|Placebo: Baseline Period|Placebo nasal spray administered once daily (OD) as 2 sprays per nostril to all enrolled participants during the 16-week Single-blind Baseline period, to assess the baseline growth velocity
435697|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435698|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435699|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435700|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435701|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435702|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435703|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435704|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435705|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435706|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435707|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435708|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435709|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435710|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435711|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435712|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435713|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435714|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435715|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435716|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435717|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435718|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435773|NCT00570687|P9|Participant Flow|Original Protocol: Insulin Lispro to TI to Exubera|12 U of subcutaneously administered insulin lispro, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, and then 4 mg of Exubera administered via inhalation
435719|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435720|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435721|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435722|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435723|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435724|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435725|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435726|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435727|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435728|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435729|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435730|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435731|NCT00570492|E2|Reported Event|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
435732|NCT00570492|E1|Reported Event|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
435733|NCT00570505|B1|Baseline|LapBand|Subjects implanted with the LapBand(R) Adjustable Gastric Band System
435734|NCT00570505|P1|Participant Flow|LapBand|"All subjects who receive the LAP-BAND System.
LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
435735|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.
LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
435736|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.
LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
435737|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.
LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
435738|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.
LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
435739|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.
LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
435740|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.
LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
435741|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.
LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
435742|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.
LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
435743|NCT00570505|E1|Reported Event|LapBand|Subjects implanted with the LapBand(R) Adjustable Gastric Band System
435753|NCT00570674|P5|Participant Flow|Phase I Dose Level 4: AC-RT|Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435754|NCT00570674|P4|Participant Flow|Phase I Dose Level 3: AC-RT|Phase I Dose Level 3 participants received Abraxane 40mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435744|NCT00570531|B1|Baseline|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.
Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.
5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
435745|NCT00570531|P1|Participant Flow|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.
Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.
5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
435746|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.
Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.
5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
435747|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.
Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.
5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
435748|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.
Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.
5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
435749|NCT00570531|E1|Reported Event|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.
Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.
5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
435750|NCT00570674|B1|Baseline|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435751|NCT00570674|P7|Participant Flow|All Phase II Participants|Participants received Abraxane according to the established recommended Phase II dose of Abraxane (50mg/m2 IV) then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435752|NCT00570674|P6|Participant Flow|Phase I Dose Level 4 Expansion Cohort: AC-RT|"Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
If no DLTs are observed at dose level 4 then ten additional participants (expansion cohort) will be enrolled at that dose level."
442739|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
435755|NCT00570674|P3|Participant Flow|Phase I Dose Level 2: AC-RT|Phase I Dose Level 2 participants received Abraxane 30mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435756|NCT00570674|P2|Participant Flow|Phase I Dose Level -1: AC-RT|Phase I Dose Level -1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435757|NCT00570674|P1|Participant Flow|Phase I Dose Level 1: ACE-RT|Phase I Dose Level 1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. One dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435758|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435759|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435760|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435761|NCT00570674|O1|Outcome|All Phase II Participants|Participants received Abraxane according to the established recommended Phase II dose of Abraxane (50mg/m2 IV) then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435762|NCT00570674|O5|Outcome|Phase I Dose Level 4: AC-RT|Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435763|NCT00570674|O4|Outcome|Phase I Dose Level 3: AC-RT|Phase I Dose Level 3 participants received Abraxane 40mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435764|NCT00570674|O3|Outcome|Phase I Dose Level 2: AC-RT|Phase I Dose Level 2 participants received Abraxane 30mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435765|NCT00570674|O2|Outcome|Phase I Dose Level -1: AC-RT|Phase I Dose Level -1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435766|NCT00570674|O1|Outcome|Phase I Dose Level 1: ACE-RT|Phase I Dose Level 1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. One dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435767|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435768|NCT00570674|E1|Reported Event|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
435769|NCT00570687|B3|Baseline|Total|Total of all reporting groups
435770|NCT00570687|B2|Baseline|Original Protocol|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435771|NCT00570687|B1|Baseline|Amendment 1|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435772|NCT00570687|P10|Participant Flow|Original Protocol: Insulin Lispro to Exubera to TI|12 U of subcutaneously administered insulin lispro, followed by 4 mg of Exubera administered via inhalation, and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
436090|NCT00571194|P1|Participant Flow|Pravastatin|Study drug given and have levels done to measure pharmacokinetics.
435774|NCT00570687|P8|Participant Flow|Original Protocol: Exubera to TI to Insulin Lispro|4 mg of Exubera administered via inhalation, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler,. and then 12 U of subcutaneously administered insulin lispro
435775|NCT00570687|P7|Participant Flow|Original Protocol: Exubera to Insulin Lispro to TI|4 mg of Exubera administered via inhalation, followed by 12 U of subcutaneously administered insulin lispro,and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
435776|NCT00570687|P6|Participant Flow|Original Protocol: TI to Exubera to Insulin Lispro|45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 4 mg of Exubera administered via inhalation, and then 12 U of subcutaneously administered insulin lispro
435777|NCT00570687|P5|Participant Flow|Original Protocol: TI to Insulin Lispro to Exubera|45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 12 U of subcutaneously administered insulin lispro, and then 4 mg of Exubera administered via inhalation
435778|NCT00570687|P4|Participant Flow|Amendment 1: 10 U Insulin Lispro Then 90 U TI|10 U subcutaneously administered insulin lispro, followed by 90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
435779|NCT00570687|P3|Participant Flow|Amendment 1: TI 90 U Then 10 U Insulin Lispro|90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
435780|NCT00570687|P2|Participant Flow|Amendment 1: 10 U Insulin Lispro Then 60 U TI|10 U subcutaneously administered insulin lispro, followed by 60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
435781|NCT00570687|P1|Participant Flow|Amendment 1: TI 60 U Then Insulin Lispro 10 U|60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
435782|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435783|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435784|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435785|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435786|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435787|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435788|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435789|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435790|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435791|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435792|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435793|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435794|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435795|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435796|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435797|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435798|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435799|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435800|NCT00570687|E6|Reported Event|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435801|NCT00570687|E5|Reported Event|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435802|NCT00570687|E4|Reported Event|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
435803|NCT00570687|E3|Reported Event|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435804|NCT00570687|E2|Reported Event|Amendment 1 - TI Inhalation Powder 60 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435805|NCT00570687|E1|Reported Event|Amendment 1 -TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
435806|NCT00570713|B3|Baseline|Total|Total of all reporting groups
436484|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
435807|NCT00570713|B2|Baseline|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435808|NCT00570713|B1|Baseline|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435809|NCT00570713|P2|Participant Flow|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435810|NCT00570713|P1|Participant Flow|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435811|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435812|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435813|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435814|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435815|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435816|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435817|NCT00570713|E2|Reported Event|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435818|NCT00570713|E1|Reported Event|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
435819|NCT00570739|B5|Baseline|Total|Total of all reporting groups
435820|NCT00570739|B4|Baseline|Pre-diabetic Group: Colesevelam|This group received 6 colesevelam tablets, 625mg, once per day for 16 weeks.
435821|NCT00570739|B3|Baseline|Pre-diabetic Group: Placebo|This group received 6 colesevelam matching placebo tablets once per day for 16 weeks
435822|NCT00570739|B2|Baseline|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
435823|NCT00570739|B1|Baseline|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
436091|NCT00571194|O1|Outcome|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
435824|NCT00570739|P4|Participant Flow|Pre-diabetic Group: Colesevelam|This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
435825|NCT00570739|P3|Participant Flow|Pre-diabetic Group: Placebo|This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.
435826|NCT00570739|P2|Participant Flow|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
435827|NCT00570739|P1|Participant Flow|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
435828|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435829|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435830|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435831|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435832|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435833|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435834|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435835|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435836|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435837|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435838|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435839|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435840|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435841|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435842|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435843|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435844|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435845|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435846|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435847|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435848|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435849|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435850|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435851|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435852|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435853|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435854|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435855|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435856|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435857|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435858|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435859|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435860|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435861|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435862|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435863|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435864|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435865|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
442740|NCT00594425|O3|Outcome|Vehicle PDT|
435866|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435867|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435868|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435869|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435870|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435871|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435872|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435873|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435874|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435875|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435876|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435877|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435878|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435879|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435880|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435881|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435882|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435883|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435884|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435885|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435886|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435887|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435888|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435889|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435890|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435891|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435892|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435893|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435894|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435895|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435896|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg once daily. The total treatment duration was 16 weeks.
435897|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The total treatment duration was 16 weeks.
435898|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435899|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435900|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435901|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435902|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435903|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435904|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435905|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435906|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435907|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435908|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
435909|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
435910|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435911|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435912|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435913|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435914|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435915|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435916|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435917|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435918|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435919|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435920|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435921|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435922|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435923|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435924|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435925|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435926|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435927|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435928|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435929|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435930|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435931|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435932|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435933|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435934|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435935|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435936|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435937|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435938|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435939|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435940|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435941|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435942|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435943|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435944|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435945|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435946|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435947|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435948|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435949|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435950|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435951|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435952|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435953|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435954|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435955|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435956|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
436092|NCT00571194|E1|Reported Event|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
442741|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
435957|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435958|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435959|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435960|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435961|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435962|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
435963|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
435964|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435965|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435966|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435967|NCT00570739|O1|Outcome|Type 2 Diabetes Group:Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435968|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435969|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435970|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
435971|NCT00570739|O1|Outcome|Type 2 Diabetes Group:Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
435972|NCT00570739|E4|Reported Event|Pre-diabetic Group: Colesevelam|This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
435973|NCT00570739|E3|Reported Event|Pre-diabetic Group: Placebo|This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.
435974|NCT00570739|E2|Reported Event|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
435975|NCT00570739|E1|Reported Event|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
435976|NCT00570765|B4|Baseline|Total|Total of all reporting groups
435977|NCT00570765|B3|Baseline|Placebo|Placebo by mouth, daily
435978|NCT00570765|B2|Baseline|50 mg|INT-747 50 mg by mouth, daily
435979|NCT00570765|B1|Baseline|10 mg|INT-747 10 mg by mouth, daily
435980|NCT00570765|P3|Participant Flow|Placebo|Placebo by mouth, daily
435981|NCT00570765|P2|Participant Flow|50 mg|INT-747 50 mg by mouth, daily
435982|NCT00570765|P1|Participant Flow|10 mg|INT-747 10 mg by mouth, daily
435983|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
435984|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
435985|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
435986|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
435987|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
435988|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
435989|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
435990|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
435991|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
435992|NCT00570765|E3|Reported Event|Placebo|Placebo by mouth, daily
435993|NCT00570765|E2|Reported Event|50 mg|INT-747 50 mg by mouth, daily
435994|NCT00570765|E1|Reported Event|10 mg|INT-747 10 mg by mouth, daily
435995|NCT00570778|B1|Baseline|Overall Population|Participants were randomized and received the following 4 treatments: 1-Two placebo capsules inhaled once daily via a SDDPI for 7 days, 2-One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days, 3-One Indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days and 4-Two Indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. There was a 7 day washout period between the four treatment periods.
435996|NCT00570778|P4|Participant Flow|D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg|"Treatment Period 1: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 2: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days."
435997|NCT00570778|P3|Participant Flow|C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo|"Treatment Period 1: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 2: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: Two placebo capsules inhaled once daily via a SDDPI for 7 days."
435998|NCT00570778|P2|Participant Flow|B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg|"Treatment Period 1: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 2: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days."
435999|NCT00570778|P1|Participant Flow|A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg|"Treatment Period 1: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a single dose dry powder inhaler (SDDPI) for 7 days.
Treatment Period 2: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days."
436000|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
436001|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
436002|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
436003|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
436004|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
436005|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
436006|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
436007|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
436008|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
436009|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
436010|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
436011|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
436012|NCT00570778|E4|Reported Event|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
436013|NCT00570778|E3|Reported Event|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
436014|NCT00570778|E2|Reported Event|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
436015|NCT00570778|E1|Reported Event|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300 μg /50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
436016|NCT00570908|B1|Baseline|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
436017|NCT00570908|P1|Participant Flow|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
436018|NCT00570908|O1|Outcome|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
436019|NCT00570908|E1|Reported Event|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
436020|NCT00570921|B1|Baseline|Fulvestrant & Everolimus|"Fulvestrant + Everolimus
Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.
Everolimus: Everolimus tablets, two-5 mg tablets a day
Fulvestrant: intramuscular, 500 mg in two divided doses- one on each side- on day 1, then 250mg on day 14, then 250 mg on day 28 and every 4 weeks +/- 3 days thereafter"
436021|NCT00570921|P1|Participant Flow|Fulvestrant + Everolimus|"Fulvestrant + Everolimus
Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
436093|NCT00571324|B1|Baseline|Subject Population|All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
436695|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436022|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus
Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
436023|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus
Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
436024|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus
Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
436025|NCT00570921|E1|Reported Event|Fulvestrant + Everolimus|"Fulvestrant + Everolimus
Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
436026|NCT00570960|B3|Baseline|Total|Total of all reporting groups
436027|NCT00570960|B2|Baseline|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three
human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
436028|NCT00570960|B1|Baseline|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three
Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
436029|NCT00570960|P2|Participant Flow|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three
human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
436030|NCT00570960|P1|Participant Flow|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three
Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
436031|NCT00570960|O2|Outcome|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three
human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
436032|NCT00570960|O1|Outcome|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three
Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
436033|NCT00570960|E2|Reported Event|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three
human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
436034|NCT00570960|E1|Reported Event|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three
Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
436035|NCT00571038|B3|Baseline|Total|Total of all reporting groups
436036|NCT00571038|B2|Baseline|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436037|NCT00571038|B1|Baseline|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436038|NCT00571038|P2|Participant Flow|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436039|NCT00571038|P1|Participant Flow|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436040|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436041|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436042|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436043|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436044|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436134|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436135|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436045|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436046|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436047|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436048|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436049|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436050|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436051|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436052|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436053|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436054|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436055|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436056|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436057|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436058|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436059|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436060|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436061|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436062|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436063|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436064|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436136|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436137|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436065|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436066|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436067|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436068|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436069|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436070|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436071|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436072|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436073|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436074|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436075|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436076|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436077|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436078|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436079|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436080|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436081|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436082|NCT00571038|E2|Reported Event|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
436083|NCT00571038|E1|Reported Event|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
436084|NCT00571103|B1|Baseline|Open Label|All subjects received the drug.
436085|NCT00571103|P1|Participant Flow|Open Label|All subjects received the drug.
436086|NCT00571103|O1|Outcome|Open Label|All subjects received the drug.
436087|NCT00571103|O1|Outcome|Open Label|All subjects received the drug.
436088|NCT00571103|E1|Reported Event|Open Label|All subjects received the drug.
436089|NCT00571194|B1|Baseline|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
436094|NCT00571324|P2|Participant Flow|Vehicle First, Then Exendin-(9-39)|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours. The following day, after another overnight fast, Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. During both infusions, blood glucose levels were measured every 20 minutes.
436095|NCT00571324|P1|Participant Flow|Exendin-(9-39) First, the Vehicle|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. The following day, after another overnight fast, normal saline (control) vehicle infusion was administered intravenously (IV) over 6 hours. During both infusions, blood glucose levels were measured every 20 minutes.
436096|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
436097|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
436098|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
436099|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
436100|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
436101|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
436102|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
436103|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
436104|NCT00571324|E2|Reported Event|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
436105|NCT00571324|E1|Reported Event|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
436106|NCT00571428|B3|Baseline|Total|Total of all reporting groups
436107|NCT00571428|B2|Baseline|30 Mcg QD / 15 Mcg BID|Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
436108|NCT00571428|B1|Baseline|15 Mcg BID / 30 Mcg QD|Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
436109|NCT00571428|P2|Participant Flow|30 Mcg QD / 15 Mcg BID|Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
436110|NCT00571428|P1|Participant Flow|15 Mcg BID / 30 Mcg QD|Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
436111|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436112|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436113|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436114|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436115|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436116|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436117|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436118|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436119|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436120|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436121|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436122|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436123|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436124|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436125|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436126|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436127|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436128|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436129|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436130|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436131|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436132|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436133|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
442742|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
436139|NCT00571428|E2|Reported Event|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
436140|NCT00571428|E1|Reported Event|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
436141|NCT00565721|B1|Baseline|Safety With Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
436142|NCT00565721|P1|Participant Flow|Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
436143|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
436144|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
436145|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
436146|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
436147|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
436148|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
436149|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
436150|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
436151|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
436152|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
436153|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
436154|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
436155|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ5 Optical Density|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
436156|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak αvβ5 Optical Density|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Full Analysis Set (FAS) subjects.
436157|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
436158|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
436159|NCT00565721|E1|Reported Event|Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
436160|NCT00565747|B3|Baseline|Total|Total of all reporting groups
436161|NCT00565747|B2|Baseline|Control Culture|Culture without GM-CSF
436162|NCT00565747|B1|Baseline|Test Culture|Culture with 2 ng/ml GM-CSF
436163|NCT00565747|P2|Participant Flow|Control Culture|Culture without GM-CSF
436164|NCT00565747|P1|Participant Flow|Test Culture|Culture with 2 ng/ml GM-CSF
436165|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
436166|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
436167|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
436168|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
436169|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
436170|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
436171|NCT00565747|E2|Reported Event|Control Culture|Culture without GM-CSF
436172|NCT00565747|E1|Reported Event|Test Culture|Culture with 2 ng/ml GM-CSF
436173|NCT00565812|B4|Baseline|Total|Total of all reporting groups
436174|NCT00565812|B3|Baseline|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436175|NCT00565812|B2|Baseline|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436393|NCT00573131|B2|Baseline|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
436176|NCT00565812|B1|Baseline|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436177|NCT00565812|P3|Participant Flow|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436178|NCT00565812|P2|Participant Flow|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436179|NCT00565812|P1|Participant Flow|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436180|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436181|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436182|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436183|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436184|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436185|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436186|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436187|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436188|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436189|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436190|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436191|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436192|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436193|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436194|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436195|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436196|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436197|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436198|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436199|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436200|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436201|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436202|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436203|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436204|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436205|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436206|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436207|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436208|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436209|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436210|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436211|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436212|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436213|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436214|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436215|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436216|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436217|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
442743|NCT00594425|O3|Outcome|Vehicle PDT|
436218|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436219|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436220|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436221|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436222|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436223|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436224|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436225|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436226|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436227|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436228|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436229|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436230|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436231|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436232|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436233|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436234|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436235|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436236|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436237|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436238|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436239|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436240|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436241|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436242|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436243|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436244|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436245|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436246|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436247|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436248|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436249|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436250|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436251|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436252|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436253|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436254|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436255|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436256|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436257|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436258|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436259|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436696|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436260|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436261|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436262|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436263|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436264|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436265|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436266|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436267|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436268|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436269|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436270|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436271|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436272|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436273|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436274|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436275|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436276|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436277|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436278|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436279|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436280|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436281|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436282|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436283|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436284|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436285|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436286|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436287|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436288|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436289|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436290|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436291|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436292|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436293|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436294|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436295|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436296|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436297|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436298|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436299|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436300|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436301|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436697|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436302|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436303|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436304|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436305|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436306|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436307|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436308|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436309|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436310|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436311|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436312|NCT00565812|E3|Reported Event|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
436313|NCT00565812|E2|Reported Event|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
436314|NCT00565812|E1|Reported Event|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
436315|NCT00571649|B3|Baseline|Total|Total of all reporting groups
436316|NCT00571649|B2|Baseline|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days (SAF population)
436317|NCT00571649|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days (SAF population)
436318|NCT00571649|P2|Participant Flow|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days during treatment period
436319|NCT00571649|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days during treatment period
436320|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436321|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436322|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436323|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436324|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436325|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436326|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436327|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436328|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436329|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436330|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436331|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436332|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436333|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436334|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436335|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436336|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436337|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436575|NCT00573313|P4|Participant Flow|Lifestyle Counseling|Subjects were enrolled into this arm for baseline measurements only.
436338|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436339|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436340|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436341|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436342|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436343|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436344|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436345|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436346|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436347|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436348|NCT00571649|E2|Reported Event|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
436349|NCT00571649|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
436350|NCT00571662|B1|Baseline|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
436351|NCT00571662|P1|Participant Flow|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
436352|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
436353|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
436354|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
436355|NCT00571662|E1|Reported Event|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
436356|NCT00571688|B3|Baseline|Total|Total of all reporting groups
436357|NCT00571688|B2|Baseline|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
436358|NCT00571688|B1|Baseline|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment
Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
436359|NCT00571688|P2|Participant Flow|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
436360|NCT00571688|P1|Participant Flow|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment
Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg intramuscularly (IM) every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) Young Mania Rating Scale (YMRS) score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
436361|NCT00571688|O2|Outcome|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
436362|NCT00571688|O1|Outcome|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment
Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
436363|NCT00571688|E2|Reported Event|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
436394|NCT00573131|B1|Baseline|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
436395|NCT00573131|P2|Participant Flow|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
436364|NCT00571688|E1|Reported Event|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment
Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
436365|NCT00571701|B3|Baseline|Total|Total of all reporting groups
436366|NCT00571701|B2|Baseline|Placebo First, Then Celecoxib|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
436367|NCT00571701|B1|Baseline|Celecoxib First, Then Placebo|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
436368|NCT00571701|P2|Participant Flow|Placebo First (12 Months), Then Celecoxib (12 Months)|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
436369|NCT00571701|P1|Participant Flow|Celecoxib First (12 Months), Then Placebo (12 Months)|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
436370|NCT00571701|O2|Outcome|Celecoxib Responders- Not Maintained|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period whose papilloma growth rate worsened by more than 0.01 at end of second treatment period.
436371|NCT00571701|O1|Outcome|Celecoxib Responders-maintained|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period that maintained response at end of second treatment.
436372|NCT00571701|O2|Outcome|Non-responders|Subjects randomized to celecoxib first with response less than 50% at end of first treatment period relative to mean disease severity prior to treatment.
436373|NCT00571701|O1|Outcome|Responders|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period relative to mean disease severity prior to treatment.
436374|NCT00571701|O4|Outcome|Placebo First- HPV 11|Subjects infected with HPV 11 treated with placebo during the first treatment period
436375|NCT00571701|O3|Outcome|Celecoxib First- HPV 11|Subjects infected with HPV 11 treated with celecoxib during the first treatment period
436376|NCT00571701|O2|Outcome|Placebo First- HPV 6|Subjects infected with HPV 6 treated with placebo during first treatment period
436377|NCT00571701|O1|Outcome|Celecoxib First - HPV 6|Subjects infected with HPV 6 treated with celecoxib during the first treatment period
436378|NCT00571701|O4|Outcome|Placebo First- Adult-onset|Adult-onset subjects treated with placebo during the first treatment
436379|NCT00571701|O3|Outcome|Celecoxib First - Adult Onset|Adult-onset subjects treated with celecoxib during the first treatment period
436380|NCT00571701|O2|Outcome|Placebo First- Juvenile-onsent|Juvenile-onset subjects treated with placebo during first treatment period
436381|NCT00571701|O1|Outcome|Celecoxib First- Juvenile Onset|Juvenile-onset subjects treated with celecoxib during the first treatment period
436382|NCT00571701|O4|Outcome|Placebo First- Females|Females treated with placebo during the first treatment period
436383|NCT00571701|O3|Outcome|Celecoxib First- Females|Females treated with celecoxib during the first treatment period
436384|NCT00571701|O2|Outcome|Placebo First- Males|Males treated with placebo during the first treatment period
436385|NCT00571701|O1|Outcome|Celecoxib First - Males|Males treated with celecoxib during the first treatment period
436386|NCT00571701|O2|Outcome|Placebo First (12 Months), Then Celecoxib (12 Months)|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
436387|NCT00571701|O1|Outcome|Celecoxib First (12 Months), Then Placebo (12 Months)|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
436388|NCT00571701|O2|Outcome|Placebo First, Then Celecoxib|"Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
436389|NCT00571701|O1|Outcome|Celecoxib First, Then Placebo|"Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
436390|NCT00571701|E2|Reported Event|Placebo|Patients who received placebo for 12 months during either time period
436391|NCT00571701|E1|Reported Event|Celecoxib|Patients who received celecoxib for 12 months during either time period
436396|NCT00573131|P1|Participant Flow|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
436397|NCT00573131|O2|Outcome|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
436398|NCT00573131|O1|Outcome|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
436399|NCT00573131|E2|Reported Event|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
436400|NCT00573131|E1|Reported Event|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
436401|NCT00573144|B3|Baseline|Total|Total of all reporting groups
436402|NCT00573144|B2|Baseline|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
436403|NCT00573144|B1|Baseline|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
436404|NCT00573144|P2|Participant Flow|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
436405|NCT00573144|P1|Participant Flow|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
436406|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
436407|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).
Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
436408|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
436409|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).
Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
436410|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
436411|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).
Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
436412|NCT00573144|E2|Reported Event|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
436413|NCT00573144|E1|Reported Event|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
436414|NCT00573157|B3|Baseline|Total|Total of all reporting groups
436415|NCT00573157|B2|Baseline|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436416|NCT00573157|B1|Baseline|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436417|NCT00573157|P2|Participant Flow|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436418|NCT00573157|P1|Participant Flow|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered subcutaneously (SC) at a loading dose of 150 milligram (mg) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose corticosteroids (CS) of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436419|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436420|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436421|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436422|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436423|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436424|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436425|NCT00573157|E2|Reported Event|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436426|NCT00573157|E1|Reported Event|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
436427|NCT00573170|B1|Baseline|All Study Participants Treated at Least Once|All study participants who were treated at least once with study medication
436428|NCT00573170|P6|Participant Flow|Placebo, Butalbital-containing Combo. Medication, Treximet|Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
436429|NCT00573170|P5|Participant Flow|Placebo, Treximet, Butalbital-containing Combo. Medication|Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
436430|NCT00573170|P4|Participant Flow|Butalbital-containing Combo. Medication, Placebo, Treximet|Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
436431|NCT00573170|P3|Participant Flow|Butalbital-containing Combo. Medication, Treximet, Placebo|Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
436432|NCT00573170|P2|Participant Flow|Treximet, Butalbital-containing Combo. Medication, Placebo|Fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
436481|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436482|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436483|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436433|NCT00573170|P1|Participant Flow|Treximet, Placebo, Butalbital-containing Combo. Medication|Fixed dose combination (combo.) tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
436434|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436435|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436436|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436437|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436438|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436439|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436440|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436441|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436442|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436443|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436444|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436445|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436446|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436447|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436448|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436449|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436450|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436451|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436452|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436453|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436454|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436455|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436456|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436457|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436458|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436459|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436460|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436461|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436462|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436463|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436464|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436465|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436466|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436467|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436468|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436469|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436470|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436471|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436472|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436473|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436474|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436475|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436476|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436477|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436478|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436479|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436480|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436485|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Butalbital-containing combination medication
436486|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Treximet
436487|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with placebo
436488|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Butalbital-containing combination medication
436489|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Treximet
436490|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with placebo
436491|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Butalbital-containing combination medication
436492|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Treximet
436493|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with placebo
436494|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436495|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436496|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436497|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436498|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436499|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436500|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
436501|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
436502|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
436503|NCT00573170|E3|Reported Event|Butalbital-containing Combination Medication|Participants who reported an SAE anytime after initial treatment with blinded Butalbital-containing combination medication, but before another initial treatment with any other investigational product
436504|NCT00573170|E2|Reported Event|Treximet|Participants who reported an SAE anytime after initial treatment with blinded Treximet, but before another initial treatment with any other investigational product
436505|NCT00573170|E1|Reported Event|Placebo|Participants who reported an SAE anytime after initial treatment with blinded placebo, but before another initial treatment with any other investigational product
436506|NCT00573183|B3|Baseline|Total|Total of all reporting groups
436507|NCT00573183|B2|Baseline|Treatment as Usual|Received standard care provided in intensive outpatient drug treatment program
436508|NCT00573183|B1|Baseline|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
436509|NCT00573183|P2|Participant Flow|Treatment as Usual|Received standard care provided in intensive outpatient drug treatment program
436510|NCT00573183|P1|Participant Flow|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
436511|NCT00573183|O2|Outcome|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
436512|NCT00573183|O1|Outcome|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
436513|NCT00573183|O2|Outcome|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
436514|NCT00573183|O1|Outcome|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
436515|NCT00573183|E2|Reported Event|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
436516|NCT00573183|E1|Reported Event|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
436517|NCT00573248|B3|Baseline|Total|Total of all reporting groups
436518|NCT00573248|B2|Baseline|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
436519|NCT00573248|B1|Baseline|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
436520|NCT00573248|P2|Participant Flow|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
436521|NCT00573248|P1|Participant Flow|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
436522|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
436576|NCT00573313|P3|Participant Flow|Sugar Pill|ALD subjects receiving Placebo three times daily for 24 weeks.
436523|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
436524|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
436525|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
436526|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
436527|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
436528|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
436529|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
436530|NCT00573248|E2|Reported Event|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
436531|NCT00573248|E1|Reported Event|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
436532|NCT00573261|B3|Baseline|Total|Total of all reporting groups
436533|NCT00573261|B2|Baseline|Placebo|"Placebo
Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436534|NCT00573261|B1|Baseline|Pregabalin|"Pregabalin medication
Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436535|NCT00573261|P2|Participant Flow|Pregabalin|"Pregabalin medication
Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436536|NCT00573261|P1|Participant Flow|Placebo|"Placebo
Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436537|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
436538|NCT00573261|O1|Outcome|Placebo|Placebo
436539|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
436540|NCT00573261|O1|Outcome|Placebo|Placebo
436541|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin
Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436542|NCT00573261|O1|Outcome|Placebo|"Placebo
Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436543|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin
Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436544|NCT00573261|O1|Outcome|Placebo|"Placebo
Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436545|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin
Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436546|NCT00573261|O1|Outcome|Placebo|"Placebo
Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436547|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
436548|NCT00573261|O1|Outcome|Placebo|Placebo
436549|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin
Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436550|NCT00573261|O1|Outcome|Placebo|"Placebo
Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436551|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
436552|NCT00573261|O1|Outcome|Placebo|Placebo
436553|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
436554|NCT00573261|O1|Outcome|Placebo|Placebo
436555|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
436556|NCT00573261|O1|Outcome|Placebo|Placebo
436557|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
436558|NCT00573261|O1|Outcome|Placebo|Placebo
436559|NCT00573261|E2|Reported Event|Pregabalin|"Pregabalin medication
Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436560|NCT00573261|E1|Reported Event|Placebo|"Placebo
Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
436561|NCT00573287|B3|Baseline|Total|Total of all reporting groups
436562|NCT00573287|B2|Baseline|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
436563|NCT00573287|B1|Baseline|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
436564|NCT00573287|P2|Participant Flow|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
436565|NCT00573287|P1|Participant Flow|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
436566|NCT00573287|O2|Outcome|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
436567|NCT00573287|O1|Outcome|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
436568|NCT00573287|E2|Reported Event|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
436569|NCT00573287|E1|Reported Event|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
436570|NCT00573313|B5|Baseline|Total|Total of all reporting groups
436571|NCT00573313|B4|Baseline|Sugar Pill Placebo|The placebo group received a sugar pill identical in appearance that was taken three times daily.
436572|NCT00573313|B3|Baseline|Lifestyle Counseling|Active drinkers non liver disease subjects
436573|NCT00573313|B2|Baseline|Healthy|Healthy subjects without alcoholism or liver disease.
436574|NCT00573313|B1|Baseline|S-adenosylmethionine (SAMe) Treatment|The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.
436577|NCT00573313|P2|Participant Flow|Healthy|Subjects were enrolled into this arm for baseline measurement only.
436578|NCT00573313|P1|Participant Flow|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
436579|NCT00573313|O2|Outcome|Sugar Pill|ALD subjects receiving placebo sugar pill three times daily for 24 weeks.
436580|NCT00573313|O1|Outcome|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
436581|NCT00573313|O2|Outcome|Sugar Pill|ALD subjects receiving Placebo three times daily for 24 weeks.
436582|NCT00573313|O1|Outcome|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
436583|NCT00573313|E2|Reported Event|Sugar Pill Placebo|The placebo group received a sugar pill identical in appearance that was taken three times daily.
436584|NCT00573313|E1|Reported Event|S-adenosylmethionine (SAMe) Treatment|The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.
436585|NCT00573391|B3|Baseline|Total|Total of all reporting groups
436586|NCT00573391|B2|Baseline|VMD With Melphalan Dose Escalation|"VMD:
Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
436587|NCT00573391|B1|Baseline|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
436588|NCT00573391|P2|Participant Flow|VMD With Melphalan Dose Escalation|"VMD:
Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
436589|NCT00573391|P1|Participant Flow|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
436590|NCT00573391|O2|Outcome|VMD With Melphalan Dose Escalation|"VMD:
Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
436591|NCT00573391|O1|Outcome|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
436592|NCT00573391|E2|Reported Event|VMD With Melphalan Dose Escalation|"VMD:
Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
436593|NCT00573391|E1|Reported Event|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
436594|NCT00573430|B4|Baseline|Total|Total of all reporting groups
436595|NCT00573430|B3|Baseline|Candesartan 32mg|Candesartan 32mg oral once daily dose
436596|NCT00573430|B2|Baseline|Candesartan 16mg|Candesartan 16mg oral once daily dose
436597|NCT00573430|B1|Baseline|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
436598|NCT00573430|P3|Participant Flow|Candesartan 32mg|Candesartan 32mg oral once daily dose
436599|NCT00573430|P2|Participant Flow|Candesartan 16mg|Candesartan 16mg oral once daily dose
436600|NCT00573430|P1|Participant Flow|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
436601|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
436602|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
436603|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
436604|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
436605|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
436606|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
436607|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
436608|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
436609|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
436610|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
436611|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
436612|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
436613|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
436614|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
436615|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
436616|NCT00573430|E3|Reported Event|Candesartan 32mg|Candesartan 32mg oral once daily dose
436617|NCT00573430|E2|Reported Event|Candesartan 16mg|Candesartan 16mg oral once daily dose
436618|NCT00573430|E1|Reported Event|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
436619|NCT00573443|B4|Baseline|Total|Total of all reporting groups
436620|NCT00573443|B3|Baseline|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436621|NCT00573443|B2|Baseline|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436622|NCT00573443|B1|Baseline|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436691|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436692|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436737|NCT00573768|P3|Participant Flow|Vehicle Gel|BID application
436623|NCT00573443|P3|Participant Flow|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436624|NCT00573443|P2|Participant Flow|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436625|NCT00573443|P1|Participant Flow|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436626|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436627|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436628|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436629|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436630|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436631|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436632|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436633|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436634|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436635|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436636|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436637|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436638|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436639|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436640|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436641|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436693|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436694|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436642|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436643|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436644|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436645|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436646|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
436647|NCT00573443|E4|Reported Event|AVP-923-30 (Open Label)|Optional 12-week Open Label phase for subjects who completed 12-week DB phase.
436648|NCT00573443|E3|Reported Event|Placebo (Double-blind)|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period.
436649|NCT00573443|E2|Reported Event|AVP-923-20 (Double-blind)|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period.
436650|NCT00573443|E1|Reported Event|AVP-923-30 (Double-blind)|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period.
436651|NCT00573469|B4|Baseline|Total|Total of all reporting groups
436652|NCT00573469|B3|Baseline|Placebo|An enteric capsule without D9421-C was given once daily.
436653|NCT00573469|B2|Baseline|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
436654|NCT00573469|B1|Baseline|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
436655|NCT00573469|P3|Participant Flow|Placebo|An enteric capsule without D9421-C was given once daily.
436656|NCT00573469|P2|Participant Flow|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
436657|NCT00573469|P1|Participant Flow|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
436658|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
436659|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
436660|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
436661|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
436662|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
436663|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
436664|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
436665|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
436666|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
436667|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
436668|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
436669|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
436670|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
436671|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
436672|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
436673|NCT00573469|E3|Reported Event|Placebo|An enteric capsule without D9421-C was given once daily.
436674|NCT00573469|E2|Reported Event|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
436675|NCT00573469|E1|Reported Event|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
436676|NCT00573508|B3|Baseline|Total|Total of all reporting groups
436677|NCT00573508|B2|Baseline|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436678|NCT00573508|B1|Baseline|Placebo|Matching placebo tablet taken once daily
436679|NCT00573508|P2|Participant Flow|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436680|NCT00573508|P1|Participant Flow|Placebo|Matching placebo tablet taken once daily
436681|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436682|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436683|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436684|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436685|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436686|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436687|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436688|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436689|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436690|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
442744|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
436698|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436699|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436700|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436701|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436702|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436703|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436704|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436705|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436706|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
436707|NCT00573508|E2|Reported Event|Solifenacin Succinate|5mg or 10mg tablet taken once daily
436708|NCT00573508|E1|Reported Event|Placebo|Matching placebo tablet taken once daily
436709|NCT00573534|B1|Baseline|Group 1|Adolescents with ADHD and an older sibling with substance use disorder
436710|NCT00573534|P1|Participant Flow|Group 1|Adolescents with ADHD and an older sibling with Substance Use Disorder
436711|NCT00573534|O1|Outcome|Lisdexamfetamine Plus Family Therapy|patients received lisdexamfetamine up to 70 mgs plus family counseling
436712|NCT00573534|O1|Outcome|Group 1|Lisdexamfetamine and family counseling
436713|NCT00573534|E1|Reported Event|Group 1|Intervention with Vyvanse
436714|NCT00573755|B3|Baseline|Total|Total of all reporting groups
436715|NCT00573755|B2|Baseline|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436716|NCT00573755|B1|Baseline|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436717|NCT00573755|P2|Participant Flow|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436718|NCT00573755|P1|Participant Flow|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436719|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436720|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436721|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436722|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436723|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436724|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436725|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436726|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436727|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436728|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436729|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436730|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436731|NCT00573755|E2|Reported Event|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436732|NCT00573755|E1|Reported Event|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
436733|NCT00573768|B4|Baseline|Total|Total of all reporting groups
436734|NCT00573768|B3|Baseline|Vehicle Gel|BID application
436735|NCT00573768|B2|Baseline|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
436736|NCT00573768|B1|Baseline|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
436738|NCT00573768|P2|Participant Flow|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
436739|NCT00573768|P1|Participant Flow|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
436740|NCT00573768|O3|Outcome|Vehicle Gel|BID application
436741|NCT00573768|O2|Outcome|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
436742|NCT00573768|O1|Outcome|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
436743|NCT00573768|E3|Reported Event|Vehicle Gel|BID application
436744|NCT00573768|E2|Reported Event|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
436745|NCT00573768|E1|Reported Event|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
436746|NCT00573859|B1|Baseline|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
436747|NCT00573859|P1|Participant Flow|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
436748|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
436749|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
436750|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
436751|NCT00573859|E1|Reported Event|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
436752|NCT00573937|B3|Baseline|Total|Total of all reporting groups
436753|NCT00573937|B2|Baseline|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
436754|NCT00573937|B1|Baseline|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
436755|NCT00573937|P2|Participant Flow|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
436756|NCT00573937|P1|Participant Flow|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
436757|NCT00573937|O2|Outcome|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
436758|NCT00573937|O1|Outcome|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
436759|NCT00573937|O2|Outcome|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
436760|NCT00573937|O1|Outcome|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
436761|NCT00573937|E2|Reported Event|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
436762|NCT00573937|E1|Reported Event|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
436763|NCT00574067|B5|Baseline|Total|Total of all reporting groups
436764|NCT00574067|B4|Baseline|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436765|NCT00574067|B3|Baseline|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436810|NCT00574080|E2|Reported Event|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
442745|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
436766|NCT00574067|B2|Baseline|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436767|NCT00574067|B1|Baseline|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
436768|NCT00574067|P4|Participant Flow|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436769|NCT00574067|P3|Participant Flow|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436770|NCT00574067|P2|Participant Flow|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436771|NCT00574067|P1|Participant Flow|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
436772|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436773|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436774|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436775|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
436776|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436777|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436778|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436779|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
436780|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436781|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436782|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436783|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
436784|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436785|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
437107|NCT00574912|O4|Outcome|1.5 Units of Glargine/kg|maximum glucose infusion rate
436786|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436787|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
436788|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436789|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436790|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436791|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
436792|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436793|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436794|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436795|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
436796|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436797|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436798|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436799|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
436800|NCT00574067|E4|Reported Event|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436801|NCT00574067|E3|Reported Event|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436802|NCT00574067|E2|Reported Event|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
436803|NCT00574067|E1|Reported Event|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
436804|NCT00574080|B3|Baseline|Total|Total of all reporting groups
436805|NCT00574080|B2|Baseline|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
436806|NCT00574080|B1|Baseline|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
436807|NCT00574080|P2|Participant Flow|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
436808|NCT00574080|P1|Participant Flow|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
436809|NCT00574080|O1|Outcome|Velcade, Thalidomide, and Dexamethasone|
436811|NCT00574080|E1|Reported Event|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
436812|NCT00574145|B3|Baseline|Total|Total of all reporting groups
436813|NCT00574145|B2|Baseline|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
436814|NCT00574145|B1|Baseline|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
436815|NCT00574145|P2|Participant Flow|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
436816|NCT00574145|P1|Participant Flow|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
436817|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
436818|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
436819|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
436820|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
436821|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
436822|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
436823|NCT00574145|E2|Reported Event|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
436824|NCT00574145|E1|Reported Event|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
436825|NCT00574171|B1|Baseline|Arm 1|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
436826|NCT00574171|P1|Participant Flow|Lapatinib and Capecitabine|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
436827|NCT00574171|O1|Outcome|Lapatinib/Capecitabine|lapatinib: 1250mg by mouth daily one hour before or after breakfast on a continuous basis. Capecitabine: 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
436828|NCT00574171|E1|Reported Event|Arm 1|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
436829|NCT00574249|B3|Baseline|Total|Total of all reporting groups
436830|NCT00574249|B2|Baseline|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436831|NCT00574249|B1|Baseline|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436832|NCT00574249|P2|Participant Flow|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment: subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 though Week 15 - topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 (maximum 100 g per week)
436833|NCT00574249|P1|Participant Flow|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 - placebo vehicle ointment to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 though Week 16 (maximum dose of 100 g per week)
436834|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436835|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436836|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436837|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436838|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436839|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436840|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436841|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436842|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436843|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436844|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436845|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436846|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436847|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436848|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436849|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436850|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436851|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436852|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436853|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436854|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436855|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436856|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436857|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436858|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436859|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436860|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436861|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436862|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436863|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436864|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436865|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436866|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436867|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436868|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436869|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436870|NCT00574249|E2|Reported Event|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
436871|NCT00574249|E1|Reported Event|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
436872|NCT00574275|B3|Baseline|Total|Total of all reporting groups
436873|NCT00574275|B2|Baseline|Aflibercept/Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436874|NCT00574275|B1|Baseline|Placebo/Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
437108|NCT00574912|O3|Outcome|1.0 Units of Glargine/kg|maximum glucose infusion rate
436875|NCT00574275|P2|Participant Flow|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436876|NCT00574275|P1|Participant Flow|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436877|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436878|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436879|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436880|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436881|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436882|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436883|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436884|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436885|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436886|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436887|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436888|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436889|NCT00574275|E2|Reported Event|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436890|NCT00574275|E1|Reported Event|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
436891|NCT00574288|B8|Baseline|Total|Total of all reporting groups
436892|NCT00574288|B7|Baseline|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436893|NCT00574288|B6|Baseline|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
436894|NCT00574288|B5|Baseline|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436895|NCT00574288|B4|Baseline|Part 1:Daratumumab 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
437013|NCT00574704|O3|Outcome|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
442746|NCT00594425|O3|Outcome|Vehicle PDT|
436896|NCT00574288|B3|Baseline|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436897|NCT00574288|B2|Baseline|Part 1:Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436898|NCT00574288|B1|Baseline|Part 1: Daratumumab Less Than (<) 4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436899|NCT00574288|P7|Participant Flow|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436900|NCT00574288|P6|Participant Flow|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
436901|NCT00574288|P5|Participant Flow|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436902|NCT00574288|P4|Participant Flow|Part 1:Daratumumab 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436903|NCT00574288|P3|Participant Flow|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436904|NCT00574288|P2|Participant Flow|Part 1:Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436905|NCT00574288|P1|Participant Flow|Part 1: Daratumumab Less Than (<) 4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436906|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436907|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
436908|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436909|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
436910|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436911|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
436912|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436913|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
436914|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436915|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
436916|NCT00574288|O4|Outcome|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436917|NCT00574288|O3|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436918|NCT00574288|O2|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions.
436919|NCT00574288|O1|Outcome|Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436920|NCT00574288|O6|Outcome|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436921|NCT00574288|O5|Outcome|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
436922|NCT00574288|O4|Outcome|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436923|NCT00574288|O3|Outcome|Part 1: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436924|NCT00574288|O2|Outcome|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436925|NCT00574288|O1|Outcome|Part 1: Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436926|NCT00574288|O7|Outcome|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436948|NCT00574405|B2|Baseline|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
436927|NCT00574288|O6|Outcome|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
436928|NCT00574288|O5|Outcome|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436929|NCT00574288|O4|Outcome|Part 1: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436930|NCT00574288|O3|Outcome|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436931|NCT00574288|O2|Outcome|Part 1: Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436932|NCT00574288|O1|Outcome|Part 1: Daratumumab Less Than (<) 4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436933|NCT00574288|E7|Reported Event|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436934|NCT00574288|E6|Reported Event|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
436935|NCT00574288|E5|Reported Event|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436936|NCT00574288|E4|Reported Event|Part 1:Daratumumab 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436937|NCT00574288|E3|Reported Event|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436938|NCT00574288|E2|Reported Event|Part 1:Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436939|NCT00574288|E1|Reported Event|Part 1: Daratumumab Less Than (<) 4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
436940|NCT00574340|B1|Baseline|All Study Participants|
436941|NCT00574340|P2|Participant Flow|Antecedent Hypoglycemia Group Then Control Study|Day 1 hypoglycemia, Day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to control study Day 1 euglycemia, day 2 hypoglycemia
436942|NCT00574340|P1|Participant Flow|Control Study Then Antecedent Hypoglycemia Study Group|Day 1 euglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to antecedent hypoglycemia study Day 1 hypoglycemia, Day 2 hypoglycemia
436943|NCT00574340|O2|Outcome|Antecedent Hypoglycemia Group|"Day 1 hypoglycemia, day 2 hypoglycemia
Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
436944|NCT00574340|O1|Outcome|Control Group|"Day 1 euglycemia, day 2 hypoglycemia
Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
436945|NCT00574340|E2|Reported Event|Antecedent Hypoglycemia Group-all Participants|"Day 1 hypoglycemia, day 2 hypoglycemia= one study
Hyperinsulinemic Hypoglycemic Clamp study: each two day study (arm) separated by 8 weeks"
436946|NCT00574340|E1|Reported Event|Control Group- All Participants|"Day 1 euglycemia, day 2 hypoglycemia= one study
Hyperinsulinemic Euglycemic Clamp study: each two day study (arm) separated by 8 weeks"
436947|NCT00574405|B3|Baseline|Total|Total of all reporting groups
437011|NCT00574704|P1|Participant Flow|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
436949|NCT00574405|B1|Baseline|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
436950|NCT00574405|P2|Participant Flow|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
436951|NCT00574405|P1|Participant Flow|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
436952|NCT00574405|O2|Outcome|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
436953|NCT00574405|O1|Outcome|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
436954|NCT00574405|E2|Reported Event|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
436955|NCT00574405|E1|Reported Event|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
436956|NCT00574548|B3|Baseline|Total|Total of all reporting groups
436957|NCT00574548|B2|Baseline|23vPS - Group 2|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436958|NCT00574548|B1|Baseline|13vPnC - Group 1.1 or 1.2|Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
436959|NCT00574548|P2|Participant Flow|23vPS - Group 2|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436960|NCT00574548|P1|Participant Flow|13vPnC - Group 1.1 or 1.2|Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
436961|NCT00574548|O3|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436962|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
436963|NCT00574548|O1|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436964|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
436965|NCT00574548|O1|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
436966|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436967|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
436968|NCT00574548|O2|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436969|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
436970|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
436971|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
436972|NCT00574548|O3|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436973|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
436974|NCT00574548|O1|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436975|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
436976|NCT00574548|O1|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
436977|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436978|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
437012|NCT00574704|O4|Outcome|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
436979|NCT00574548|O2|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436980|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
436981|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
436982|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
436983|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436984|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
436985|NCT00574548|O2|Outcome|13vPnC / 23vPS Vaccination 2 (Year 1)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
436986|NCT00574548|O1|Outcome|13vPnC Vaccination 1 (Year 0)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
436987|NCT00574548|O2|Outcome|13vPnC / 13vPnC Vaccination 2 (Year 1)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436988|NCT00574548|O1|Outcome|13vPnC Vaccination 1 (Year 0)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
436989|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436990|NCT00574548|O1|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
436991|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
436992|NCT00574548|O1|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
436993|NCT00574548|E10|Reported Event|23vPS / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436994|NCT00574548|E9|Reported Event|13vPnC / 23vPS: 6 Month Follow-up After Vax 2 (Year 1)|13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
436995|NCT00574548|E8|Reported Event|13vPnC / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)|13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
436996|NCT00574548|E7|Reported Event|23vPS / 13vPnC (Year 1)|"23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=32; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=68."
436997|NCT00574548|E6|Reported Event|13vPnC / 23vPS (Year 1)|"13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=50; systematic (solicited) Local Reactions N=198; systematic (solicited) Systemic Events N=120."
436998|NCT00574548|E5|Reported Event|13vPnC / 13vPnC (Year 1)|"13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=22; systematic (solicited) Local Reactions N=97; systematic (solicited) Systemic Events N=54."
436999|NCT00574548|E4|Reported Event|23vPS: 6 Month Follow-up After Vax 1 (Year 0)|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
437000|NCT00574548|E3|Reported Event|13vPnC: 6 Month Follow-up After Vax 1 (Year 0)|Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
437001|NCT00574548|E2|Reported Event|23vPS (Year 0)|"Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=49; systematic (solicited) Local Reactions N=102; systematic (solicited) Systemic Events N=86."
437002|NCT00574548|E1|Reported Event|13vPnC (Year 0)|"Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=90; systematic (solicited) Local Reactions N=256; systematic (solicited) Systemic Events N=163."
437003|NCT00574704|B5|Baseline|Total|Total of all reporting groups
437004|NCT00574704|B4|Baseline|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
437005|NCT00574704|B3|Baseline|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
437006|NCT00574704|B2|Baseline|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
437007|NCT00574704|B1|Baseline|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
437008|NCT00574704|P4|Participant Flow|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
437009|NCT00574704|P3|Participant Flow|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
437010|NCT00574704|P2|Participant Flow|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
437014|NCT00574704|O2|Outcome|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
437015|NCT00574704|O1|Outcome|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
437016|NCT00574704|E4|Reported Event|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
437017|NCT00574704|E3|Reported Event|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
437018|NCT00574704|E2|Reported Event|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
437019|NCT00574704|E1|Reported Event|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
437020|NCT00574795|B1|Baseline|13vPnC|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
437021|NCT00574795|P1|Participant Flow|13vPnC|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
437022|NCT00574795|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose)
437023|NCT00574795|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose)
437024|NCT00574795|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
437025|NCT00574795|O4|Outcome|13vPnC Toddler Dose|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
437026|NCT00574795|O3|Outcome|13vPnC Dose 3|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
437027|NCT00574795|O2|Outcome|13vPnC Dose 2|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
437028|NCT00574795|O1|Outcome|13vPnC Dose 1|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).
437029|NCT00574795|O4|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
437030|NCT00574795|O3|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
437031|NCT00574795|O2|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
437032|NCT00574795|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).
437033|NCT00574795|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
437034|NCT00574795|E3|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months (toddler dose).
437035|NCT00574795|E2|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
437036|NCT00574795|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
437037|NCT00574834|B4|Baseline|Total|Total of all reporting groups
437038|NCT00574834|B3|Baseline|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.
Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
437039|NCT00574834|B2|Baseline|HCTZ|"Patients randomized to 6 months treatment of HCTZ.
HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
437040|NCT00574834|B1|Baseline|Ramipril|"Patients randomized to 6 months treatment of Ramipril.
Ramipril: Ramipril 20 mg once daily for 6 months"
437041|NCT00574834|P3|Participant Flow|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.
Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
437042|NCT00574834|P2|Participant Flow|HCTZ|"Patients randomized to 6 months treatment of HCTZ.
HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
437043|NCT00574834|P1|Participant Flow|Ramipril|"Patients randomized to 6 months treatment of Ramipril.
Ramipril: Ramipril 20 mg once daily for 6 months"
437044|NCT00574834|O3|Outcome|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.
Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
437045|NCT00574834|O2|Outcome|HCTZ|"Patients randomized to 6 months treatment of HCTZ.
HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
437046|NCT00574834|O1|Outcome|Ramipril|"Patients randomized to 6 months treatment of Ramipril.
Ramipril: Ramipril 20 mg once daily for 6 months"
437047|NCT00574834|E3|Reported Event|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.
Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
437048|NCT00574834|E2|Reported Event|HCTZ|"Patients randomized to 6 months treatment of HCTZ.
HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
437049|NCT00574834|E1|Reported Event|Ramipril|"Patients randomized to 6 months treatment of Ramipril.
Ramipril: Ramipril 20 mg once daily for 6 months"
437050|NCT00574847|B3|Baseline|Total|Total of all reporting groups
437051|NCT00574847|B2|Baseline|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437052|NCT00574847|B1|Baseline|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437106|NCT00574912|O5|Outcome|2.0 Units of Glargine/kg|maximum glucose infusion rate
437053|NCT00574847|P2|Participant Flow|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437054|NCT00574847|P1|Participant Flow|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437055|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437056|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437057|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437058|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437059|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437060|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437061|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437062|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437063|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437064|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437065|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437066|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437067|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437068|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437069|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437070|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437071|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437072|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437073|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437074|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437075|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437076|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437077|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437078|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437079|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437080|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437081|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437082|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437280|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437083|NCT00574847|E2|Reported Event|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437084|NCT00574847|E1|Reported Event|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
437085|NCT00574873|B3|Baseline|Total|Total of all reporting groups
437086|NCT00574873|B2|Baseline|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
437087|NCT00574873|B1|Baseline|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
437088|NCT00574873|P2|Participant Flow|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
437089|NCT00574873|P1|Participant Flow|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
437090|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
437091|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
437092|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
437093|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
437094|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
437095|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
437096|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
437097|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
437098|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
437099|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
437100|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
437101|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
437102|NCT00574873|E2|Reported Event|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
437103|NCT00574873|E1|Reported Event|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
437104|NCT00574912|B1|Baseline|1--All Interventions|"Arm: Other: 1--All interventions
All participant will be given all 5 interventions in the same order
Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,"
437105|NCT00574912|P1|Participant Flow|1 All Interventions|"Other: 1--All interventions
All participant will be given all 5 interventions in the same order
Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,"
437109|NCT00574912|O2|Outcome|0.5 Units of Glargine/kg|maximum glucose infusion rate
437110|NCT00574912|O1|Outcome|Placebo|Maximum glucose infusion rate
437111|NCT00574912|E5|Reported Event|2.0 Units of Glargine/kg Body Weight|"2.0 units of glargine/kg body weight
Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
437112|NCT00574912|E4|Reported Event|1.5 Units of Glargine/kg Body Weight|"1.5 units of glargine/kg body weight
Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
437113|NCT00574912|E3|Reported Event|1 Unit of Glargine/kg Body Weight|"1 unit of glargine/kg body weight
Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
437114|NCT00574912|E2|Reported Event|0.5 Units of Glargine/kg Body Weight|"0.5 units of Glargine/kg body weight
Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
437115|NCT00574912|E1|Reported Event|Placebo|"Placebo
Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
437116|NCT00574990|B4|Baseline|Total|Total of all reporting groups
437117|NCT00574990|B3|Baseline|VA Pharmacists|VA Pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
437118|NCT00574990|B2|Baseline|VA Nurses|VA Nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
437119|NCT00574990|B1|Baseline|VA Physicians|VA physicians who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
437120|NCT00574990|P3|Participant Flow|VA Pharmacists|VA Pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
437121|NCT00574990|P2|Participant Flow|VA Nurses|VA Nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
437122|NCT00574990|P1|Participant Flow|VA Physicians|VA Physicians who have spent at least one year in the VA and be familiar with the VA's electronic health record, CPRS.
437123|NCT00574990|O3|Outcome|VA Pharmacists|VA pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
437124|NCT00574990|O2|Outcome|VA Nurses|VA nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
437125|NCT00574990|O1|Outcome|VA Physicians|VA providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
437126|NCT00574990|O3|Outcome|Pharmacists|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
437127|NCT00574990|O2|Outcome|Nurses|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
437128|NCT00574990|O1|Outcome|Physicians|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
437129|NCT00574990|E3|Reported Event|VA Pharmacists|VA Pharmacists who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
437130|NCT00574990|E2|Reported Event|VA Nurses|VA Nurses who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
437131|NCT00574990|E1|Reported Event|VA Physicians|VA Physicians who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
437132|NCT00575016|B5|Baseline|Total|Total of all reporting groups
437133|NCT00575016|B4|Baseline|Placebo|Normal saline (placebo)
437134|NCT00575016|B3|Baseline|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
437135|NCT00575016|B2|Baseline|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
437136|NCT00575016|B1|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
437137|NCT00575016|P4|Participant Flow|Placebo|Normal saline (placebo)
437138|NCT00575016|P3|Participant Flow|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
437139|NCT00575016|P2|Participant Flow|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
437140|NCT00575016|P1|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
437141|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
437142|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
437143|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
437144|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
437145|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
437146|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
437147|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
437148|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
437149|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
437150|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
437151|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
437152|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
437153|NCT00575016|E4|Reported Event|Placebo|Normal saline (placebo)
437154|NCT00575016|E3|Reported Event|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
437155|NCT00575016|E2|Reported Event|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
437156|NCT00575016|E1|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
437157|NCT00575029|B1|Baseline|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
437158|NCT00575029|P1|Participant Flow|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
437159|NCT00575029|O1|Outcome|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
437160|NCT00575029|O1|Outcome|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
437161|NCT00575029|E1|Reported Event|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
437162|NCT00575042|B1|Baseline|Patients Treated With Fenofibrate|
437163|NCT00575042|P1|Participant Flow|Patients Treated With Fenofibrate|
437164|NCT00575042|O2|Outcome|Post Treatment|
437165|NCT00575042|O1|Outcome|Pre Treatment|
437166|NCT00575042|E1|Reported Event|Patients Treated With Fenofibrate|
437167|NCT00575094|B1|Baseline|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
437168|NCT00575094|P1|Participant Flow|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
437169|NCT00575094|O1|Outcome|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
437170|NCT00575094|E1|Reported Event|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
437171|NCT00575146|B1|Baseline|Ketogenic Diet|ketogenic diet
437172|NCT00575146|P1|Participant Flow|Ketogenic Diet|unrestricted ketogenic diet (< 50-60 g carbohydrates per day) and dietary supplementary products provided by Tavarlin
437173|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
437174|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
437175|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
437176|NCT00575146|E1|Reported Event|Ketogenic Diet|ketogenic diet
437177|NCT00575185|B3|Baseline|Total|Total of all reporting groups
437178|NCT00575185|B2|Baseline|Placebo|"placebo 2 tablets twice daily for 21 days
placebo : Placebo tablets orally twice daily for 21 days."
437179|NCT00575185|B1|Baseline|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days
Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
437180|NCT00575185|P2|Participant Flow|Placebo|"placebo 2 tablets twice daily for 21 days
placebo : Placebo tablets orally twice daily for 21 days."
437181|NCT00575185|P1|Participant Flow|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days
Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
437182|NCT00575185|O2|Outcome|Placebo|"placebo 2 tablets twice daily for 21 days
placebo: Placebo tablets orally twice daily for 21 days."
437183|NCT00575185|O1|Outcome|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days
Valomaciclovir: 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
437184|NCT00575185|O2|Outcome|Placebo|"placebo 2 tablets twice daily for 21 days
placebo : Placebo tablets orally twice daily for 21 days."
437185|NCT00575185|O1|Outcome|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days
Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
437186|NCT00575185|E2|Reported Event|Placebo|"placebo 2 tablets twice daily for 21 days
placebo : Placebo tablets orally twice daily for 21 days."
437187|NCT00575185|E1|Reported Event|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days
Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
437188|NCT00575367|B3|Baseline|Total|Total of all reporting groups
437189|NCT00575367|B2|Baseline|Vigamox|
437190|NCT00575367|B1|Baseline|AzaSite|
437191|NCT00575367|P2|Participant Flow|Vigamox|
437192|NCT00575367|P1|Participant Flow|AzaSite|
437193|NCT00575367|O2|Outcome|Vigamox|
437194|NCT00575367|O1|Outcome|AzaSite|
437195|NCT00575367|E2|Reported Event|Vigamox|
437196|NCT00575367|E1|Reported Event|AzaSite|
437197|NCT00575380|B3|Baseline|Total|Total of all reporting groups
437198|NCT00575380|B2|Baseline|Vigamox|
437199|NCT00575380|B1|Baseline|Azasite|
437200|NCT00575380|P2|Participant Flow|Vigamox|
437201|NCT00575380|P1|Participant Flow|Azasite|
437202|NCT00575380|O2|Outcome|Vigamox|
437203|NCT00575380|O1|Outcome|Azasite|
437204|NCT00575380|O2|Outcome|Vigamox|
437205|NCT00575380|O1|Outcome|Azasite|
437206|NCT00575380|E2|Reported Event|Vigamox|
437207|NCT00575380|E1|Reported Event|Azasite|
437208|NCT00575510|B4|Baseline|Total|Total of all reporting groups
437209|NCT00575510|B3|Baseline|Standard Care Only|Clinical standard of care at time of study
437210|NCT00575510|B2|Baseline|Active Control|nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
437211|NCT00575510|B1|Baseline|Intervention|Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
437212|NCT00575510|P3|Participant Flow|Standard Care Only|Clinical standard of care at time of study
437213|NCT00575510|P2|Participant Flow|Active Control|nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
437214|NCT00575510|P1|Participant Flow|Intervention|Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
437215|NCT00575510|O3|Outcome|Standard Care Only|Clinical standard of care at time of study
437216|NCT00575510|O2|Outcome|Active Control|"non-targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Active control: Partial intervention (full intervention minus cultural-specific component)"
437217|NCT00575510|O1|Outcome|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Intervention: Multiple component intervention based in the unified theory of behavior"
437218|NCT00575510|O3|Outcome|Standard Care Only|Clinical standard of care at time of study
437219|NCT00575510|O2|Outcome|Active Control|"nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Active control: Partial intervention (full intervention minus cultural-specific component)"
437220|NCT00575510|O1|Outcome|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Intervention: Multiple component intervention based in the unified theory of behavior"
437221|NCT00575510|E3|Reported Event|Standard Care Only|Clinical standard of care at time of study
437222|NCT00575510|E2|Reported Event|Active Control|"nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Active control: Partial intervention (full intervention minus cultural-specific component)"
437223|NCT00575510|E1|Reported Event|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Intervention: Multiple component intervention based in the unified theory of behavior"
437224|NCT00575588|B3|Baseline|Total|Total of all reporting groups
437225|NCT00575588|B2|Baseline|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
437226|NCT00575588|B1|Baseline|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
437227|NCT00575588|P2|Participant Flow|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
437228|NCT00575588|P1|Participant Flow|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
437229|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
437230|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
437231|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
437232|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
437233|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
437234|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
437235|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
437236|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
437237|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
437238|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
437239|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
437240|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
437241|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
437242|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
437243|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
437244|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
437245|NCT00575588|E2|Reported Event|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
437246|NCT00575588|E1|Reported Event|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
437247|NCT00575666|B3|Baseline|Total|Total of all reporting groups
437248|NCT00575666|B2|Baseline|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
437249|NCT00575666|B1|Baseline|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
437250|NCT00575666|P2|Participant Flow|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
437251|NCT00575666|P1|Participant Flow|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
437252|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437253|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437254|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437255|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437256|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437257|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437258|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437259|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437260|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437261|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437262|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437263|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437264|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437265|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437266|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437267|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437268|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437269|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437270|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437271|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437272|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437273|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437274|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437275|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437276|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437277|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437278|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
437279|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
437286|NCT00575666|E2|Reported Event|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
437287|NCT00575666|E1|Reported Event|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
437288|NCT00575887|B1|Baseline|Dose-Dense Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.
Number of cycles: Until progression or unacceptable toxicity"
437289|NCT00575887|P1|Participant Flow|Dose-Dense Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.
Number of cycles: Until progression or unacceptable toxicity"
437290|NCT00575887|O1|Outcome|Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.
Number of cycles: Until progression or unacceptable toxicity"
437291|NCT00575887|E1|Reported Event|Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.
Number of cycles: Until progression or unacceptable toxicity"
437292|NCT00575965|B1|Baseline|Simvastatin|Single arm, phase II study. All 18 patients received study drug.
437293|NCT00575965|P1|Participant Flow|Simvastatin|Single arm, phase II study. All 18 patients received study drug.
437294|NCT00575965|O1|Outcome|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
437295|NCT00575965|O1|Outcome|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
437296|NCT00575965|E1|Reported Event|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
437297|NCT00579059|B3|Baseline|Total|Total of all reporting groups
437298|NCT00579059|B2|Baseline|Maxim® Regular Tibia|Tibia with Modular Polyethylene
437299|NCT00579059|B1|Baseline|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
437300|NCT00579059|P2|Participant Flow|Maxim® Regular Tibia|Tibia with Modular Polyethylene
437301|NCT00579059|P1|Participant Flow|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
437302|NCT00579059|O2|Outcome|Maxim® Regular Tibia|Tibia with Modular Polyethylene
437303|NCT00579059|O1|Outcome|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
437304|NCT00579059|O2|Outcome|Maxim® Regular Tibia|Tibia with Modular Polyethylene
437305|NCT00579059|O1|Outcome|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
437306|NCT00579059|E2|Reported Event|Maxim® Regular Tibia|Tibia with Modular Polyethylene
437307|NCT00579059|E1|Reported Event|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
437308|NCT00579098|B3|Baseline|Total|Total of all reporting groups
437309|NCT00579098|B2|Baseline|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
437310|NCT00579098|B1|Baseline|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
437311|NCT00579098|P2|Participant Flow|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
437312|NCT00579098|P1|Participant Flow|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
437313|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
437314|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
437315|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
437316|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
437317|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
437318|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
437319|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
437320|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
437321|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
437322|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
437323|NCT00579098|E2|Reported Event|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
437324|NCT00579098|E1|Reported Event|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
437325|NCT00579111|B3|Baseline|Total|Total of all reporting groups
437326|NCT00579111|B2|Baseline|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
437327|NCT00579111|B1|Baseline|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
437328|NCT00579111|P2|Participant Flow|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
437329|NCT00579111|P1|Participant Flow|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
437330|NCT00579111|O2|Outcome|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
437331|NCT00579111|O1|Outcome|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
437332|NCT00579111|O2|Outcome|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
437333|NCT00579111|O1|Outcome|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
437334|NCT00579111|E2|Reported Event|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
437335|NCT00579111|E1|Reported Event|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
437336|NCT00579137|B1|Baseline|Single Group|only one group
437337|NCT00579137|P1|Participant Flow|Participants With SCID or Primary Immunodeficiency Disorder|"Participants received an allogeneic stem cell transplant with the following conditioning:
Day 8 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2
D7 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2
D6 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2
D5 Anti-CD45 MAb 400ug/kg over 6 hr, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2
D4 Anti-CD45 MAb 400ug/kg over 6 hr, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2
D3 Anti-CD45 MAb 400ug/kg over 6 hr
D2 Anti-CD45 MAb 400ug/kg over 6 hr
D1 rest
D0 Stem Cell Infusion
Campath dose is weight based: for patients less than 15 kg administer Campath 3 mg; for patients >15 kg to 30 kg administer Campath 5 mg; for patients > 30 kg administer Campath 10 mg. Campath will be dosed and administered as per CAGT SOP.
Anti-CD45 infusion will be administered according to CAGT SOPs."
437338|NCT00579137|O1|Outcome|Single Group|only one group
437339|NCT00579137|O1|Outcome|Single Group|only one group
437340|NCT00579137|O1|Outcome|Single Group|only one group
437341|NCT00579137|O1|Outcome|Single Group|only one group
437342|NCT00579137|E1|Reported Event|Single Group|only one group
437343|NCT00579254|B1|Baseline|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
437344|NCT00579254|P1|Participant Flow|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
437345|NCT00579254|O1|Outcome|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
437346|NCT00579254|E1|Reported Event|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
437347|NCT00579345|B9|Baseline|Total|Total of all reporting groups
437348|NCT00579345|B8|Baseline|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
437349|NCT00579345|B7|Baseline|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
437350|NCT00579345|B6|Baseline|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
437351|NCT00579345|B5|Baseline|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
437352|NCT00579345|B4|Baseline|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
437353|NCT00579345|B3|Baseline|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
437354|NCT00579345|B2|Baseline|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
437355|NCT00579345|B1|Baseline|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
437356|NCT00579345|P8|Participant Flow|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
437357|NCT00579345|P7|Participant Flow|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
437438|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437439|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437358|NCT00579345|P6|Participant Flow|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
437359|NCT00579345|P5|Participant Flow|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
437360|NCT00579345|P4|Participant Flow|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
437361|NCT00579345|P3|Participant Flow|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
437362|NCT00579345|P2|Participant Flow|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
437363|NCT00579345|P1|Participant Flow|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
437364|NCT00579345|O2|Outcome|FLU (cTIV or eTIV_a)|Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
437365|NCT00579345|O1|Outcome|FLU (cTIV or eTIV_a) + PV|Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV).
437366|NCT00579345|O4|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
437367|NCT00579345|O3|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only (cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
437368|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
437369|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
437370|NCT00579345|O4|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
437371|NCT00579345|O3|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only (cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
437372|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
437373|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
437374|NCT00579345|O2|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
437375|NCT00579345|O1|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
442747|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
437376|NCT00579345|O6|Outcome|eTIV_a+PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
437377|NCT00579345|O5|Outcome|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
437378|NCT00579345|O4|Outcome|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
437379|NCT00579345|O3|Outcome|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study.
437380|NCT00579345|O2|Outcome|FLU (cTIV or eTIV_a)|Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)).
437381|NCT00579345|O1|Outcome|FLU (cTIV or eTIV_a) + PV|Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV)).
437382|NCT00579345|O4|Outcome|eTIV_a (Elderly)|Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
437383|NCT00579345|O3|Outcome|cTIV (Elderly)|Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
437384|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
437385|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
437386|NCT00579345|E8|Reported Event|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
437387|NCT00579345|E7|Reported Event|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age)were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
437388|NCT00579345|E6|Reported Event|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age)were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
437389|NCT00579345|E5|Reported Event|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
437390|NCT00579345|E4|Reported Event|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
437391|NCT00579345|E3|Reported Event|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
437392|NCT00579345|E2|Reported Event|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
437440|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437393|NCT00579345|E1|Reported Event|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
437394|NCT00579501|B1|Baseline|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
437395|NCT00579501|P1|Participant Flow|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
437396|NCT00579501|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
437397|NCT00579501|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
437398|NCT00579501|E1|Reported Event|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
437399|NCT00579670|B6|Baseline|Total|Total of all reporting groups
437400|NCT00579670|B5|Baseline|Ziprasidone Unknown|Details are unknown.
437401|NCT00579670|B4|Baseline|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437402|NCT00579670|B3|Baseline|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437403|NCT00579670|B2|Baseline|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437404|NCT00579670|B1|Baseline|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437405|NCT00579670|P5|Participant Flow|Ziprasidone Unknown|Details are unknown.
437406|NCT00579670|P4|Participant Flow|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437407|NCT00579670|P3|Participant Flow|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437408|NCT00579670|P2|Participant Flow|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437409|NCT00579670|P1|Participant Flow|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437410|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437411|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437412|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437413|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437414|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437415|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437416|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437417|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437418|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437419|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437420|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437421|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437422|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437423|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437424|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437425|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437426|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437427|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437428|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437429|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437430|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437431|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437432|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437433|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437434|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437435|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437436|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437437|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437441|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437442|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437443|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437444|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437445|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437446|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437447|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437448|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437449|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437450|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437451|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437452|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437453|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437454|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437455|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437456|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437457|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437458|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437459|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437460|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437461|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437462|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437463|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437464|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437465|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437466|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437467|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437468|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437469|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437470|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437471|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437472|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437473|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437474|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437475|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437476|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437477|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437478|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437479|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437480|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437481|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437482|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437483|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437484|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437485|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437486|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437487|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437488|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437489|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437490|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
437491|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
437492|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
437493|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
437494|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437495|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437496|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437497|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437498|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437499|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
442748|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
437500|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437501|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437502|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437503|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437504|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437505|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437506|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437507|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437508|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437509|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437510|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437511|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437512|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437513|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437514|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437515|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437516|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437517|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437518|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437519|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437520|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437521|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437522|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437523|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437524|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437525|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437526|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437527|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437528|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437529|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437530|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437531|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437532|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437533|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437534|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437535|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437536|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437537|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437538|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437539|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437540|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437541|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437542|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437543|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437544|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437545|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437546|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437547|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437548|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437549|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437550|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437551|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437552|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437553|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437554|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437555|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437556|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437557|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437558|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437559|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437560|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437561|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437562|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437563|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437564|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
442749|NCT00594425|O3|Outcome|Vehicle PDT|
437565|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437566|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437567|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437568|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437569|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437570|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437571|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437572|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437573|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437574|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437575|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437576|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437577|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437578|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437579|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437580|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437581|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437582|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437583|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437584|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437585|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437586|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437587|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437588|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437589|NCT00579670|O5|Outcome|Ziprasodone Unknown|Details are unknown.
437590|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437591|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437592|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437593|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg per day.
437594|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437595|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437596|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437597|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437598|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437599|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437600|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437601|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437602|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437603|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437604|NCT00579670|O1|Outcome|Ziprasidone Total|Ziprasidone all doses received combined.
437605|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
437606|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
437607|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437608|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437609|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
437610|NCT00579670|E10|Reported Event|Above SmPC Ziprasidone > 160 mg|Above SmPC Ziprasidone > 160 mg per day; defined as all participants in FAS population who received at least 1 PO dose above 160 mg per day or any IM dose above 40 mg per day or with an unknown dose or formulation.
437611|NCT00579670|E9|Reported Event|Within SmPC Ziprasidone = 160 mg|Within SmPC Ziprasidone = 160 mg; defined as all participants in the FAS population who had PO doses = 160 mg per day.
437612|NCT00579670|E8|Reported Event|Within SmPC Ziprasidone 120 to < 160 mg|Within SmPC Ziprasidone 120 to < 160 mg; defined as all participants in the FAS population who had PO doses between 120 mg and < 160 mg per day.
437613|NCT00579670|E7|Reported Event|Within SmPC Ziprasidone 80 to < 120 mg|Within SmPC Ziprasidone 80 to < 120 mg; defined as all participants in the FAS population who had PO doses between 80 mg and < 120 mg per day.
437614|NCT00579670|E6|Reported Event|Within SmPC Ziprasidone < 80 mg|Within SmPC < 80 mg per day; defined as all participants in the FAS population who had PO doses up to 80 mg per day and all IM doses up to and including 40 mg per day.
437615|NCT00579670|E5|Reported Event|Ziprasidone Unknown|Details are unknown.
437616|NCT00579670|E4|Reported Event|Ziprasidone >=160 mg|Ziprasidone 160 mg or greater per day.
437617|NCT00579670|E3|Reported Event|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
437618|NCT00579670|E2|Reported Event|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
437619|NCT00579670|E1|Reported Event|Ziprasidone < 80 mg|Ziprasidone up to 80 mg per day.
437620|NCT00579813|B3|Baseline|Total|Total of all reporting groups
437621|NCT00579813|B2|Baseline|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
437762|NCT00580671|P2|Participant Flow|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
437622|NCT00579813|B1|Baseline|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
437623|NCT00579813|P2|Participant Flow|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
437624|NCT00579813|P1|Participant Flow|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
437625|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
437626|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
437627|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
437628|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
437629|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
437630|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
437631|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
437632|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
437633|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
437634|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
437635|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
437636|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
437637|NCT00579813|E2|Reported Event|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
437638|NCT00579813|E1|Reported Event|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
437639|NCT00579826|B3|Baseline|Total|Total of all reporting groups
437640|NCT00579826|B2|Baseline|Placebo|"Placebo, daily for 6 months
Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
437641|NCT00579826|B1|Baseline|Letrozole|"Letrozole, 2.5 mg daily for 6 months
Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
437642|NCT00579826|P2|Participant Flow|Placebo|"Placebo, daily for 6 months
Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
437643|NCT00579826|P1|Participant Flow|Letrozole|"Letrozole, 2.5 mg daily for 6 months
Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
437644|NCT00579826|O2|Outcome|Placebo|"Placebo, daily for 6 months
Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
437645|NCT00579826|O1|Outcome|Letrozole|"Letrozole, 2.5 mg daily for 6 months
Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
437646|NCT00579826|O2|Outcome|Placebo|"Placebo, daily for 6 months
Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
437647|NCT00579826|O1|Outcome|Letrozole|"Letrozole, 2.5 mg daily for 6 months
Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
437648|NCT00579826|O2|Outcome|Placebo|"Placebo, daily for 6 months
Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
437649|NCT00579826|O1|Outcome|Letrozole|"Letrozole, 2.5 mg daily for 6 months
Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
437650|NCT00579826|E2|Reported Event|Placebo for 6 Months; Open Label Letrozole 2.5 mg Daily|"Placebo, daily for 6 months
Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
437651|NCT00579826|E1|Reported Event|Letrozole, 2.5 mg Daily for 12 Months|"Letrozole, 2.5 mg daily for 6 months
Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
437652|NCT00579982|B1|Baseline|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437653|NCT00579982|P1|Participant Flow|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437654|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437655|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437656|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437657|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437658|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437659|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437660|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437766|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
437661|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437662|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437663|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437664|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437665|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437666|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437667|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437668|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437669|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437670|NCT00579982|E1|Reported Event|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
437671|NCT00580034|B1|Baseline|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d sc or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
437672|NCT00580034|P2|Participant Flow|Donor Apheresis|"Donor must be a sibling, half sibling, parent, child or first cousin familial relationship and 3-5/6 Human Leukocyte Antigen matched related to subject. They must not have any medical condition which would make apheresis and G-CSF administration more than a minimal risk, and should have the following:
Adequate cardiac function by history and physical examination
bilirubin and hepatic transaminases < 2.5 x upper limit of normal
normal hematologic parameters Females should have a negative serum pregnancy test."
437673|NCT00580034|P1|Participant Flow|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously(dose will be rounded to the nearest whole vial size and may be divided into bid dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
437674|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
437675|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
437703|NCT00580294|B1|Baseline|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
437676|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
437677|NCT00580034|E1|Reported Event|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneously or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
437678|NCT00580073|B1|Baseline|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
437679|NCT00580073|P1|Participant Flow|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU (5-fluorouracil) Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
437680|NCT00580073|O1|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
437681|NCT00580073|O1|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
437682|NCT00580073|O1|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
437683|NCT00580073|E1|Reported Event|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
437684|NCT00580138|B1|Baseline|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
437685|NCT00580138|P1|Participant Flow|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
437686|NCT00580138|O1|Outcome|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
437687|NCT00580138|E1|Reported Event|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
437688|NCT00580151|B3|Baseline|Total|Total of all reporting groups
437689|NCT00580151|B2|Baseline|Control Group|placebo : 1 dose every 6 hours
437690|NCT00580151|B1|Baseline|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
437691|NCT00580151|P2|Participant Flow|Control Group|placebo : 1 dose every 6 hours
437692|NCT00580151|P1|Participant Flow|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
437693|NCT00580151|O2|Outcome|Control Group|placebo : 1 dose every 6 hours
437694|NCT00580151|O1|Outcome|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
437695|NCT00580151|O2|Outcome|Control Group|placebo : 1 dose every 6 hours
437696|NCT00580151|O1|Outcome|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
437697|NCT00580151|E2|Reported Event|Control Group|placebo : 1 dose every 6 hours
437698|NCT00580151|E1|Reported Event|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
437699|NCT00580229|B1|Baseline|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
437700|NCT00580229|P1|Participant Flow|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
437701|NCT00580229|O1|Outcome|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
437702|NCT00580229|E1|Reported Event|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
442750|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
437704|NCT00580294|P1|Participant Flow|Oxymorphone|participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed
437705|NCT00580294|O1|Outcome|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
437706|NCT00580294|E1|Reported Event|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
437707|NCT00580333|B1|Baseline|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)
cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles
bevacizumab: Preoperatively: Given IV on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel
doxorubicin: Postoperative: Given intravenously for four 2-week cycles
cyclophosphamide: Postoperative: Given intravenously for four two-week cycles
paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)"
437708|NCT00580333|P1|Participant Flow|Cisplatin/Avastin|"cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles
bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel
doxorubicin: Postoperative: Given intravenously for four 2-week cycles
cyclophosphamide: Postoperative: Given intravenously for four two-week cycles
paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)"
437709|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)
cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles
bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel
doxorubicin: Postoperative: Given intravenously for four 2-week cycles
cyclophosphamide: Postoperative: Given intravenously for four two-week cycles
paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
437710|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)
cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles
bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel
doxorubicin: Postoperative: Given intravenously for four 2-week cycles
cyclophosphamide: Postoperative: Given intravenously for four two-week cycles
paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
437711|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)
cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles
bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel
doxorubicin: Postoperative: Given intravenously for four 2-week cycles
cyclophosphamide: Postoperative: Given intravenously for four two-week cycles
paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
437712|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)
cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles
bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel
doxorubicin: Postoperative: Given intravenously for four 2-week cycles
cyclophosphamide: Postoperative: Given intravenously for four two-week cycles
paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
437735|NCT00580502|E1|Reported Event|LAP-BAND® Adjustable Gastric Band (LAGB®) Operations|A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
437736|NCT00580606|B3|Baseline|Total|Total of all reporting groups
437763|NCT00580671|P1|Participant Flow|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/ Cognitive Behavior Therapy (CBT) + Contingency Management (CM) / Behavioral Parent Training (BPT)
437764|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
437765|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
437713|NCT00580333|E1|Reported Event|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)
cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles
bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel
doxorubicin: Postoperative: Given intravenously for four 2-week cycles
cyclophosphamide: Postoperative: Given intravenously for four two-week cycles
paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
437714|NCT00580372|B1|Baseline|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.
VAD: 3 Cycles (3rd cycle optional):
Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20
High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:
Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1
Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg
EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
437715|NCT00580372|P1|Participant Flow|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.
VAD: 3 Cycles (3rd cycle optional):
Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20
High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:
Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1
Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg
EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
437716|NCT00580372|O1|Outcome|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.
VAD: 3 Cycles (3rd cycle optional):
Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20
High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:
Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1
Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg
EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
437717|NCT00580372|E1|Reported Event|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.
VAD: 3 Cycles (3rd cycle optional):
Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20
High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:
Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1
Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg
EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
437718|NCT00580398|B3|Baseline|Total|Total of all reporting groups
437719|NCT00580398|B2|Baseline|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
437720|NCT00580398|B1|Baseline|Control|Usual care included physician advice to quit smoking.
437721|NCT00580398|P2|Participant Flow|Intervention|Intervention participants were provided with a 12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling targeted to the issues of thoracic cancer patients. We had proposed to offer 7 counseling sessions but were flexible in offering additional sessions when needed. The counseling was delivered by a certified Tobacco Treatment Counselor using motivational interviewing (MI) techniques.
437722|NCT00580398|P1|Participant Flow|Control|Usual care included physician advice to quit smoking.
437723|NCT00580398|O2|Outcome|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
437724|NCT00580398|O1|Outcome|Control|Usual care included physician advice to quit smoking.
437725|NCT00580398|O2|Outcome|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
437726|NCT00580398|O1|Outcome|Control|Usual care included physician advice to quit smoking.
437727|NCT00580398|E2|Reported Event|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
437728|NCT00580398|E1|Reported Event|Control|Usual care included physician advice to quit smoking.
437729|NCT00580502|B1|Baseline|LAP-BAND® Adjustable Gastric Band (LAGB®) Operations|A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
437730|NCT00580502|P1|Participant Flow|Lap-Band|"Low BMI patients who will go through Lap-band surgery.
LAP-BAND® Adjustable Gastric Band (LAGB®): Bariatric surgery: LAGB"
437731|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
437732|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
437733|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
437734|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
437737|NCT00580606|B2|Baseline|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
437738|NCT00580606|B1|Baseline|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
437739|NCT00580606|P2|Participant Flow|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
437740|NCT00580606|P1|Participant Flow|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
437741|NCT00580606|O2|Outcome|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
437742|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
437743|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
437744|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
437745|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
437759|NCT00580671|B2|Baseline|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
437760|NCT00580671|B1|Baseline|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
437761|NCT00580671|P3|Participant Flow|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
437746|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
437747|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
437748|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
437749|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
437750|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
437751|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
437752|NCT00580606|E5|Reported Event|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|After 44 weeks of open label therapy, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. After completion of this Week 44 OFC, subjects then either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
437753|NCT00580606|E4|Reported Event|Low Dose Peanut SLIT (Double Blind to Open Label)|After completion of the 5,000 mg Oral Food Challenge (OFC) at Week 44, subjects/study staff are unblinded and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
437754|NCT00580606|E3|Reported Event|High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After 44 weeks of open label SLIT, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. SLIT=Sublingual Immunotherapy
437755|NCT00580606|E2|Reported Event|Placebo Before Week 44 OFC (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
437756|NCT00580606|E1|Reported Event|Low Dose Peanut SLIT Before Week 44 OFC (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
437757|NCT00580671|B4|Baseline|Total|Total of all reporting groups
437758|NCT00580671|B3|Baseline|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
437767|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
437768|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
437769|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
437770|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
437771|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
437772|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
437773|NCT00580671|E3|Reported Event|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
437774|NCT00580671|E2|Reported Event|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
437775|NCT00580671|E1|Reported Event|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
437776|NCT00580723|B1|Baseline|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
437777|NCT00580723|P1|Participant Flow|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
437778|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
437779|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
437780|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
437781|NCT00580723|E1|Reported Event|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
437782|NCT00580788|B5|Baseline|Total|Total of all reporting groups
437783|NCT00580788|B4|Baseline|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
437784|NCT00580788|B3|Baseline|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
437785|NCT00580788|B2|Baseline|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
437786|NCT00580788|B1|Baseline|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437787|NCT00580788|P4|Participant Flow|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
437788|NCT00580788|P3|Participant Flow|Group 3|PTHrP (1-36) 5 pmol/kg/hr
437789|NCT00580788|P2|Participant Flow|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
437790|NCT00580788|P1|Participant Flow|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
437791|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
437792|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
437793|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
437794|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437795|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
437796|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
437797|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
437798|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437799|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
437800|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
437801|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
437802|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437803|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
437804|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
437805|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
437806|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437807|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
437808|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
437809|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
437810|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437811|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
437812|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
437813|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
437814|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437815|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
437816|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
437817|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
437818|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
437819|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
437820|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
437821|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
437822|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
437823|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
437824|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
437825|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
437826|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
437827|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
437828|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
437829|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
437830|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437831|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
437832|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
437833|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
437834|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437835|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
437836|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
437837|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
437838|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437839|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
437840|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
437841|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
437842|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437843|NCT00580788|E4|Reported Event|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
437844|NCT00580788|E3|Reported Event|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
437845|NCT00580788|E2|Reported Event|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
437846|NCT00580788|E1|Reported Event|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
437847|NCT00580801|B4|Baseline|Total|Total of all reporting groups
437848|NCT00580801|B3|Baseline|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437849|NCT00580801|B2|Baseline|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437850|NCT00580801|B1|Baseline|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437851|NCT00580801|P3|Participant Flow|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437852|NCT00580801|P2|Participant Flow|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437853|NCT00580801|P1|Participant Flow|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437854|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437855|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437856|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437857|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437858|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437859|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437860|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437861|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437862|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437863|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437864|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437865|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437920|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437866|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437867|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437868|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437869|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437870|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437871|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437872|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437873|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437874|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437875|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437876|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437877|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437878|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437879|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437880|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437881|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437882|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437883|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437884|NCT00580801|E3|Reported Event|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437885|NCT00580801|E2|Reported Event|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
437921|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437886|NCT00580801|E1|Reported Event|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
437887|NCT00580840|B1|Baseline|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437888|NCT00580840|P4|Participant Flow|PLO + MTX|Placebo (PTO) + Methotrexate (MTX)
437889|NCT00580840|P3|Participant Flow|CZP 200 mg and PLO + MTX|Certolizumab Pegol (CZP) 200 mg and Placebo (PLO) + Methotrexate (MTX)
437890|NCT00580840|P2|Participant Flow|CZP 400 mg and PLO + MTX|Certolizumab Pegol (CZP) 400 mg and Placebo (PLO) + Methotrexate (MTX)
437891|NCT00580840|P1|Participant Flow|Overall|Overall for the Run-in period includes all 333 subjects that entered the study. Overall for the Double-blind period includes all 209 subjects that completed the Run-in period.
437892|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437893|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437894|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437895|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437896|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437897|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437898|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437899|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437900|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437901|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437902|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437903|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437904|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437905|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437906|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437907|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437908|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437909|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437910|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437911|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437912|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437913|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437914|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437915|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437916|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437917|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437918|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437919|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
442751|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
437922|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437923|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437924|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437925|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437926|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437927|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437928|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437929|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437930|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437931|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437932|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437933|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437934|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437935|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437936|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437937|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437938|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437939|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437940|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437941|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437942|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437943|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437944|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437945|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437946|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437947|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437948|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437949|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437950|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437951|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437952|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437953|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437954|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
442752|NCT00594425|O3|Outcome|Vehicle PDT|
437955|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437956|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437957|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437958|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437959|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437960|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437961|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437962|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437963|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437964|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437965|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437966|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437967|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437968|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437969|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437970|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437971|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437972|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437973|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437974|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437975|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437976|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437977|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437978|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437979|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437980|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437981|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437982|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437983|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437984|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437985|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437986|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437987|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437988|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
437989|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437990|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437991|NCT00580840|E4|Reported Event|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
438049|NCT00581100|B2|Baseline|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
437992|NCT00580840|E3|Reported Event|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
437993|NCT00580840|E2|Reported Event|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
437994|NCT00580840|E1|Reported Event|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
437995|NCT00580853|B4|Baseline|Total|Total of all reporting groups
437996|NCT00580853|B3|Baseline|Placebo|"Placebo Control
Placebo: Placebo"
437997|NCT00580853|B2|Baseline|Bupropion|"Bupropion 300mg/day
bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
437998|NCT00580853|B1|Baseline|Varenicline|"varenicline 2mg/day
varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
437999|NCT00580853|P3|Participant Flow|Placebo|"Placebo Control
Placebo: Placebo"
438000|NCT00580853|P2|Participant Flow|Bupropion|"Bupropion 300mg/day
bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
438001|NCT00580853|P1|Participant Flow|Varenicline|"varenicline 2mg/day
varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
438002|NCT00580853|O3|Outcome|Placebo|"Placebo Control
Placebo: Placebo"
438003|NCT00580853|O2|Outcome|Bupropion|"Bupropion 300mg/day
bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
438004|NCT00580853|O1|Outcome|Varenicline|"varenicline 2mg/day
varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
438005|NCT00580853|O3|Outcome|Placebo|"Placebo Control
Placebo: Placebo"
438006|NCT00580853|O2|Outcome|Bupropion|"Bupropion 300mg/day
bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
438007|NCT00580853|O1|Outcome|Varenicline|"varenicline 2mg/day
varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
438008|NCT00580853|E3|Reported Event|Placebo|"Placebo Control
Placebo: Placebo"
438009|NCT00580853|E2|Reported Event|Bupropion|"Bupropion 300mg/day
bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
438010|NCT00580853|E1|Reported Event|Varenicline|"varenicline 2mg/day
varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
438011|NCT00580866|B3|Baseline|Total|Total of all reporting groups
438012|NCT00580866|B2|Baseline|PT Only Group|
438013|NCT00580866|B1|Baseline|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
438014|NCT00580866|P2|Participant Flow|PT Only Group|
438015|NCT00580866|P1|Participant Flow|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
438016|NCT00580866|O2|Outcome|PT Only Group|
438017|NCT00580866|O1|Outcome|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
438018|NCT00580866|O2|Outcome|PT Only Group|
438019|NCT00580866|O1|Outcome|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
438020|NCT00580866|E2|Reported Event|PT Only Group|
438021|NCT00580866|E1|Reported Event|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
438022|NCT00580957|B3|Baseline|Total|Total of all reporting groups
438023|NCT00580957|B2|Baseline|Intact Then Blocked|"Saline will be used instead of trimethaphan during insulin clamp
Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
438024|NCT00580957|B1|Baseline|Blocked Then Intact|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp
Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.
L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
438025|NCT00580957|P2|Participant Flow|Intact|"Saline will be used instead of trimethaphan during insulin clamp
Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
438026|NCT00580957|P1|Participant Flow|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp
Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.
L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
438027|NCT00580957|O2|Outcome|Intact|"Saline will be used instead of trimethaphan during insulin clamp
Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
438028|NCT00580957|O1|Outcome|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp
Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.
L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
438029|NCT00580957|E2|Reported Event|Intact|"Saline will be used instead of trimethaphan during insulin clamp
Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
438030|NCT00580957|E1|Reported Event|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp
Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.
L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
438031|NCT00580970|B3|Baseline|Total|Total of all reporting groups
438032|NCT00580970|B2|Baseline|Supportive Care (Lovastatin) (Ineligible)|The 20 subjects started Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy). The subjects were ineligible because they did not complete 6 months of Lovastatin.
438033|NCT00580970|B1|Baseline|Supportive Care (Lovastatin) (Evaluable)|The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
438034|NCT00580970|P1|Participant Flow|Supportive Care (Lovastatin)|"Subjects took Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued for 12 months.
73 subjects enrolled in the study, 72 started treatment, 20 subjects were ineligible for analysis, and a total of 53 evaluable subjects."
438035|NCT00580970|O1|Outcome|Supportive Care (Lovastatin) (Evaluable)|The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
438036|NCT00580970|E1|Reported Event|Supportive Care (Lovastatin)|"Subjects who started treatment on Lovastatin on the first day of radiation therapy (external beam radiation therapy (EBRT) alone, brachytherapy alone, or EBRT followed by brachytherapy).
73 subjects enrolled in the study, 72 started Lovastatin treatment, 20 subjects were ineligible for analysis, and a total of 53 subjects evaluable for analysis. 72 subjects started treatment and were at risk for Adverse Events (AEs) and Serious Adverse Events(SAEs)."
438037|NCT00580983|B1|Baseline|Chemo-IMRT|"Chemotherapy:
Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.
Intensity-modulated Radiation Therapy (IMRT):
Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.
Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
438038|NCT00580983|P1|Participant Flow|Chemo-IMRT|"Chemotherapy:
Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.
Intensity-modulated Radiation Therapy (IMRT):
Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.
Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
438039|NCT00580983|O1|Outcome|Chemo-IMRT|"Chemotherapy:
Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.
Intensity-modulated Radiation Therapy (IMRT):
Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.
Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
438040|NCT00580983|O1|Outcome|Chemo-IMRT|"Chemotherapy:
Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.
Intensity-modulated Radiation Therapy (IMRT):
Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.
Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
438041|NCT00580983|E1|Reported Event|Chemo-IMRT|"Chemotherapy:
Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.
Intensity-modulated Radiation Therapy (IMRT):
Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.
Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
438042|NCT00581061|B1|Baseline|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
438043|NCT00581061|P1|Participant Flow|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
438044|NCT00581061|O1|Outcome|Vesicare|Number of people who experienced side effects while taking Vesicare, per study protocol. These are known side effects indicated on the drug label that occur to subjects on this medication.
438045|NCT00581061|O1|Outcome|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
438046|NCT00581061|O1|Outcome|Vesicare|Number of days it takes for subjects to achieve pad free urinary continence
438047|NCT00581061|E1|Reported Event|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
438048|NCT00581100|B3|Baseline|Total|Total of all reporting groups
438050|NCT00581100|B1|Baseline|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438051|NCT00581100|P2|Participant Flow|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438052|NCT00581100|P1|Participant Flow|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438053|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438054|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438055|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438056|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438057|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438058|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438059|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438060|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438061|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438062|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438063|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438064|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438065|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438066|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438067|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438068|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438069|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438070|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438071|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438072|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438073|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438074|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438075|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438076|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438077|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438078|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438079|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438080|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438081|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438082|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438083|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438084|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438085|NCT00581100|E2|Reported Event|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
438086|NCT00581100|E1|Reported Event|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
438087|NCT00581113|B3|Baseline|Total|Total of all reporting groups
438088|NCT00581113|B2|Baseline|Standard Whole Brain RT|Standard Whole Brain Radiotherapy
438089|NCT00581113|B1|Baseline|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
438090|NCT00581113|P2|Participant Flow|Standard Whole Brain RT|Standard Whole Brain Radiotherapy
438091|NCT00581113|P1|Participant Flow|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
438092|NCT00581113|O2|Outcome|Standard Whole Brain RT|Standard Whole Brain RT
438093|NCT00581113|O1|Outcome|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
438094|NCT00581113|O2|Outcome|Standard Whole Brain RT|Standard Whole Brain RT
438428|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
438095|NCT00581113|O1|Outcome|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
438096|NCT00581113|E2|Reported Event|Standard Whole Brain RT|Standard Whole Brain RT
438097|NCT00581113|E1|Reported Event|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
438098|NCT00581230|B1|Baseline|Laryngoscopy Without RAMP, Then Laryngoscopy With RAMP|First, laryngoscopy was preformed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Positioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™. Second, the Rapid Airway Management Positioner (RAMP) was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, the second time with RAMP, and the laryngeal view was recorded.
438099|NCT00581230|P1|Participant Flow|Entire Study|All the patients first underwent mask ventilation and laryngoscopy with Macintosh size 4 blade laryngoscope without RAMP. Second, all patients underwent laryngoscopy with RAMP--the RAMP pillow was inflated for all patients and the ease of Mask ventilation and Cormack Lehane laryngoscopy view with Macintosh size 4 laryngoscope was recorded.
438100|NCT00581230|O2|Outcome|Laryngoscopy With RAMP|The Cormack Lehane grade glottic view obtained during laryngoscopy with inflated RAMP pillow. In all participants, laryngoscopy with the Rapid Airway Management Positioner (RAMP) was performed second (after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
438101|NCT00581230|O1|Outcome|Laryngoscopy Without RAMP|The Cormack Lehane grade view obtained with laryngoscopy when there was no RAMP pillow. In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.
438102|NCT00581230|O2|Outcome|Laryngoscopy With RAMP|In this crossover study, all participants then received laryngoscopy with the Rapid Airway Management Positioner (RAMP) (immediately after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
438103|NCT00581230|O1|Outcome|Laryngoscopy Without RAMP|In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.
438104|NCT00581230|E1|Reported Event|Entire Study|This is a crossover study, all the patients 1st underwent mask ventilation and laryngoscopy with Macintosh size 4 blade laryngoscope. After this, the RAMP pillow was inflated for all patients and the ease of Mask ventilation and Cormack Lehane laryngoscopy view with Macintosh size 4 laryngoscope was recorded.
438105|NCT00581256|B3|Baseline|Total|Total of all reporting groups
438106|NCT00581256|B2|Baseline|3DRT|"Best 3-dimensional standard PWTF technique
3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
438107|NCT00581256|B1|Baseline|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)
IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
438108|NCT00581256|P2|Participant Flow|3DRT|"Best 3-dimensional standard PWTF technique
3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
438109|NCT00581256|P1|Participant Flow|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)
IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
438110|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique
3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
438111|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)
IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
438112|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique
3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
438361|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
438113|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)
IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
438114|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique
3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
438115|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)
IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
438116|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique
3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
438117|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)
IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
438118|NCT00581256|E2|Reported Event|3DRT|"Best 3-dimensional standard PWTF technique
3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
438119|NCT00581256|E1|Reported Event|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)
IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
438120|NCT00581308|B1|Baseline|PAS Subjects|Subjects with occluder in place upon leaving cath lab
438121|NCT00581308|P1|Participant Flow|PAS Subjects|Subjects with occluder in place upon leaving cath lab
438122|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
438123|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
438124|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
438125|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
438126|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
438127|NCT00581308|E1|Reported Event|PAS Subjects|Subjects with occluder in place upon leaving cath lab
438128|NCT00581347|B3|Baseline|Total|Total of all reporting groups
438129|NCT00581347|B2|Baseline|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
438130|NCT00581347|B1|Baseline|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.
Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.
Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.
Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
438131|NCT00581347|P2|Participant Flow|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
438132|NCT00581347|P1|Participant Flow|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.
Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.
Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.
Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
438133|NCT00581347|O2|Outcome|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
438161|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
442753|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
438134|NCT00581347|O1|Outcome|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.
Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.
Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.
Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
438135|NCT00581347|O2|Outcome|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
438136|NCT00581347|O1|Outcome|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.
Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.
Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.
Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
438137|NCT00581347|E2|Reported Event|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
438138|NCT00581347|E1|Reported Event|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.
Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.
Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.
Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
438139|NCT00581360|B1|Baseline|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
438140|NCT00581360|P1|Participant Flow|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
438141|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
438142|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
438143|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
438144|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
438145|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
438146|NCT00581360|E1|Reported Event|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
438147|NCT00581386|B4|Baseline|Total|Total of all reporting groups
438148|NCT00581386|B3|Baseline|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
438149|NCT00581386|B2|Baseline|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
438150|NCT00581386|B1|Baseline|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
438151|NCT00581386|P3|Participant Flow|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
438152|NCT00581386|P2|Participant Flow|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
438153|NCT00581386|P1|Participant Flow|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
438154|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
438155|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
438156|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
438157|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
438158|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
438159|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
438160|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
438162|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
438163|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
438164|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
438165|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
438166|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
438167|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
438168|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
438169|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
438170|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
438171|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
438172|NCT00581386|E3|Reported Event|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
438173|NCT00581386|E2|Reported Event|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
438174|NCT00581386|E1|Reported Event|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
438175|NCT00581399|B3|Baseline|Total|Total of all reporting groups
438176|NCT00581399|B2|Baseline|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
438177|NCT00581399|B1|Baseline|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
438178|NCT00581399|P2|Participant Flow|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
438179|NCT00581399|P1|Participant Flow|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
438180|NCT00581399|O2|Outcome|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
438181|NCT00581399|O1|Outcome|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
438182|NCT00581399|O2|Outcome|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
438183|NCT00581399|O1|Outcome|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
438184|NCT00581399|E2|Reported Event|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
438185|NCT00581399|E1|Reported Event|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
438186|NCT00571922|B3|Baseline|Total|Total of all reporting groups
438187|NCT00571922|B2|Baseline|Placebo|placebo: matching placebo
438188|NCT00571922|B1|Baseline|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
438189|NCT00571922|P2|Participant Flow|Placebo|placebo: matching placebo
438190|NCT00571922|P1|Participant Flow|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
438191|NCT00571922|O2|Outcome|Placebo|placebo: matching placebo
438192|NCT00571922|O1|Outcome|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
438193|NCT00571922|O2|Outcome|Placebo|placebo: matching placebo
438194|NCT00571922|O1|Outcome|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
438195|NCT00571922|E2|Reported Event|Placebo|placebo: matching placebo
438196|NCT00571922|E1|Reported Event|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
438197|NCT00571948|B3|Baseline|Total|Total of all reporting groups
438198|NCT00571948|B2|Baseline|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
438199|NCT00571948|B1|Baseline|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
438200|NCT00571948|P2|Participant Flow|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
438201|NCT00571948|P1|Participant Flow|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
438202|NCT00571948|O2|Outcome|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
438203|NCT00571948|O1|Outcome|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
438204|NCT00571948|E2|Reported Event|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
438205|NCT00571948|E1|Reported Event|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
438206|NCT00571961|B1|Baseline|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
438207|NCT00571961|P1|Participant Flow|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r once daily in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
438208|NCT00571961|O1|Outcome|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
438209|NCT00571961|E1|Reported Event|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
438210|NCT00571974|B3|Baseline|Total|Total of all reporting groups
438211|NCT00571974|B2|Baseline|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
438212|NCT00571974|B1|Baseline|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.
The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
438213|NCT00571974|P2|Participant Flow|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
438214|NCT00571974|P1|Participant Flow|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.
The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
438215|NCT00571974|O1|Outcome|Phase II|Subjects treated with the MTD.
438216|NCT00571974|O1|Outcome|Phase I|Participants in the Phase I part of the study.
438217|NCT00571974|E2|Reported Event|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
438218|NCT00571974|E1|Reported Event|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.
The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
438219|NCT00571987|B1|Baseline|RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
438220|NCT00571987|P1|Participant Flow|Subjects Received RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
438221|NCT00571987|O1|Outcome|Recurrences at the Site|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
438222|NCT00571987|O1|Outcome|Margin Status|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
438223|NCT00571987|E1|Reported Event|RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
438224|NCT00572039|B3|Baseline|Total|Total of all reporting groups
438225|NCT00572039|B2|Baseline|Supportive Therapy|"Supportive Therapy (ST)
ST: ST will be delivered in subjects' homes over the course of 6 weeks."
438226|NCT00572039|B1|Baseline|Problem Solving Treatment|"Problem Solving Treatment (PST)
PST: PST will be delivered in subjects' homes over the course of 6 weeks."
438227|NCT00572039|P2|Participant Flow|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
438228|NCT00572039|P1|Participant Flow|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
438229|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
438230|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
438231|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
438232|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
438233|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
438234|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
438235|NCT00572039|O2|Outcome|Supportive Therapy|"Supportive Therapy (ST)
ST: ST will be delivered in subjects' homes over the course of 6 weeks."
438236|NCT00572039|O1|Outcome|Problem Solving Treatment|"Problem Solving Treatment (PST)
PST: PST will be delivered in subjects' homes over the course of 6 weeks."
438237|NCT00572039|E2|Reported Event|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
438238|NCT00572039|E1|Reported Event|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
438239|NCT00572117|B3|Baseline|Total|Total of all reporting groups
438240|NCT00572117|B2|Baseline|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.
Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
438241|NCT00572117|B1|Baseline|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.
Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
438242|NCT00572117|P2|Participant Flow|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.
Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
438272|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438273|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438274|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438243|NCT00572117|P1|Participant Flow|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.
Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
438244|NCT00572117|O2|Outcome|Placebo (Inert Pill) Arm|Change in HAM-D score from baseline
438245|NCT00572117|O1|Outcome|Topiramate|Change in HAM-D score from baseline
438246|NCT00572117|O2|Outcome|Placebo (Inert Pill) Arm|Change in average number of drinks/heavy drinking day
438247|NCT00572117|O1|Outcome|Topiramate|Change in average number of drinks/heavy drinking day
438248|NCT00572117|E2|Reported Event|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.
Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
438249|NCT00572117|E1|Reported Event|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.
Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
438250|NCT00572156|B5|Baseline|Total|Total of all reporting groups
438251|NCT00572156|B4|Baseline|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438252|NCT00572156|B3|Baseline|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438253|NCT00572156|B2|Baseline|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438254|NCT00572156|B1|Baseline|45 rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438255|NCT00572156|P4|Participant Flow|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438256|NCT00572156|P3|Participant Flow|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438257|NCT00572156|P2|Participant Flow|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and Recombinant Human Insulin-Like Growth Factor-1 (rhIGF-1) (Mecasermin) 50µg/kg once daily injections
438258|NCT00572156|P1|Participant Flow|45 rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): Recombinant Human Growth Hormone (rhGH) (Somatropin) 45µg/kg once daily injection
438259|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438260|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438261|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438262|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438263|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438264|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438265|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438266|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438267|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438268|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438269|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438270|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438271|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438359|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
438275|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438276|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438277|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438278|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438279|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438280|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438281|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438282|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438283|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438284|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438285|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438286|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438287|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438288|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438289|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438290|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438291|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438292|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438293|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438294|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438295|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438296|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438297|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438298|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438299|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438300|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438301|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438302|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438303|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438304|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438305|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438306|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438307|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438308|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438309|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438310|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438360|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
438311|NCT00572156|E4|Reported Event|4. 45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
438312|NCT00572156|E3|Reported Event|3. 45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
438313|NCT00572156|E2|Reported Event|2. 45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
438314|NCT00572156|E1|Reported Event|1. rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
438315|NCT00572260|B1|Baseline|Antimicrobial Prophylaxis Administration With Daptomycin|
438316|NCT00572260|P1|Participant Flow|Antimicrobial Prophylaxis Administration With Daptomycin|
438317|NCT00572260|O1|Outcome|Patients Undergoing Cardiac Surgery|Patients undergoing cardiac valve replacement and coronary artery bypass grafting
438318|NCT00572260|E1|Reported Event|Antimicrobial Prophylaxis Administration With Daptomycin|
438319|NCT00572468|B3|Baseline|Total|Total of all reporting groups
438320|NCT00572468|B2|Baseline|Placebo|Participants were randomized into the placebo arm of this trial.
438321|NCT00572468|B1|Baseline|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
438322|NCT00572468|P2|Participant Flow|Placebo|Participants were randomized into the placebo arm of this trial.
438323|NCT00572468|P1|Participant Flow|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
438324|NCT00572468|O2|Outcome|Placebo|Participants were randomized into the placebo arm of this trial.
438325|NCT00572468|O1|Outcome|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
438326|NCT00572468|O2|Outcome|Placebo|Participants were randomized into the placebo arm of this trial.
438327|NCT00572468|O1|Outcome|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
438328|NCT00572468|E2|Reported Event|Placebo|Participants were randomized into the placebo arm of this trial.
438329|NCT00572468|E1|Reported Event|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
438330|NCT00572533|B3|Baseline|Total|Total of all reporting groups
438331|NCT00572533|B2|Baseline|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
438332|NCT00572533|B1|Baseline|Control|ESA Dose Adjustment per standard Anemia Management Protocol
438333|NCT00572533|P2|Participant Flow|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
438334|NCT00572533|P1|Participant Flow|Control|ESA Dose Adjustment per standard Anemia Management Protocol
438335|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
438336|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
438337|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
438338|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
438339|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
438340|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
438341|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
438342|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
438343|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
438344|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
438345|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
438346|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
438347|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
438348|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
438349|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
438350|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
438351|NCT00572533|E2|Reported Event|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
438352|NCT00572533|E1|Reported Event|Control|ESA Dose Adjustment per standard Anemia Management Protocol
438353|NCT00572572|B3|Baseline|Total|Total of all reporting groups
438354|NCT00572572|B2|Baseline|Arm B: Placebo, Then Aprepitant|"Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2
Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
438355|NCT00572572|B1|Baseline|Arm A: Aprepitant, Then Placebo|"Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2
Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
438356|NCT00572572|P2|Participant Flow|Arm B: Placebo, Then Aprepitant|"Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2
Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
438357|NCT00572572|P1|Participant Flow|Arm A: Aprepitant, Then Placebo|"Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2
Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
438358|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
442754|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
438362|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
438363|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
438364|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
438365|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
438366|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
438367|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
438368|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
438369|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
438370|NCT00572572|E2|Reported Event|Placebo, Then Aprepitant.|"Arm A, Study Cycle 2
Arm B, Study Cycle 1
Placebo: Matched placebo PO daily on days 3 through 7
Subjects will be stratified prior to randomization based on previous administration of chemotherapy.
Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.
Arm A, Study Cycle 2
Arm B, Study Cycle 1"
438371|NCT00572572|E1|Reported Event|Aprepitant, Then Placebo|"Arm A, Study Cycle 1
Arm B, Study Cycle 2
Aprepitant: Aprepitant 125mg PO day 3 then 80mg on days 4 through 7
Subjects will be stratified prior to randomization based on previous administration of chemotherapy.
Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.
Arm A, Study Cycle 1
Arm B, Study Cycle 2"
438372|NCT00572624|B3|Baseline|Total|Total of all reporting groups
438373|NCT00572624|B2|Baseline|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438374|NCT00572624|B1|Baseline|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438375|NCT00572624|P2|Participant Flow|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438376|NCT00572624|P1|Participant Flow|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438377|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438378|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438379|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438380|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438381|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438382|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438383|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438384|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438385|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438386|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438387|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438388|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438389|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438390|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438391|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438392|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438393|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438394|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438395|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438396|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438397|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438398|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438399|NCT00572624|E2|Reported Event|Gastric Bypass Surgery|Participants who received gastric bypass surgery
438400|NCT00572624|E1|Reported Event|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
438401|NCT00572728|B1|Baseline|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies"
438402|NCT00572728|P1|Participant Flow|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies"
438425|NCT00572897|P2|Participant Flow|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
438426|NCT00572897|P1|Participant Flow|Sibling Donor|Patients received a stem cell transplant from sibling
438427|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
442755|NCT00594425|O3|Outcome|Vehicle PDT|
438403|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies"
438404|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies"
438405|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
CT: Undergo 18F-FLT PET/CT
18F-FLT: Undergo 18F-FLT PET/CT
PET: Undergo 18F-FLT PET/CT"
438406|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies"
438407|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies"
438408|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies"
438409|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post-NAC (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies"
438410|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies"
438411|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies"
438412|NCT00572728|E1|Reported Event|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Fluorothymidine F-18: Undergo 18F-FLT PET/CT
Positron Emission Tomography: Undergo 18F-FLT PET/CT
Computed Tomography: Undergo 18F-FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies"
438413|NCT00572832|B3|Baseline|Total|Total of all reporting groups
438414|NCT00572832|B2|Baseline|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
438415|NCT00572832|B1|Baseline|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
438416|NCT00572832|P2|Participant Flow|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
438417|NCT00572832|P1|Participant Flow|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
438418|NCT00572832|O2|Outcome|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
438419|NCT00572832|O1|Outcome|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
438420|NCT00572832|E2|Reported Event|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
438421|NCT00572832|E1|Reported Event|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
438422|NCT00572897|B3|Baseline|Total|Total of all reporting groups
438423|NCT00572897|B2|Baseline|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
438424|NCT00572897|B1|Baseline|Sibling Donor|Patients received a stem cell transplant from sibling
442756|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
438429|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
438430|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
438431|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
438432|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
438433|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
438434|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
438435|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
438436|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
438437|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
438438|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
438439|NCT00572897|E2|Reported Event|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
438440|NCT00572897|E1|Reported Event|Sibling Donor|Patients received a stem cell transplant from sibling
438441|NCT00572910|B7|Baseline|Total|Total of all reporting groups
438442|NCT00572910|B6|Baseline|Placebo (PBO / PBO)|Participants who were vaccinated with Placebo on Day 1 and Day 28.
438443|NCT00572910|B5|Baseline|V710 (90 mcg / 90 mcg) + MAA|Participants who were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
438444|NCT00572910|B4|Baseline|V710 (60 mcg / PBO) + MAA|Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28.
438445|NCT00572910|B3|Baseline|V710 (60 mcg / 60 mcg) + MAA|Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
438446|NCT00572910|B2|Baseline|V710 (60 mcg / PBO)|Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28.
438447|NCT00572910|B1|Baseline|V710 (60 mcg / 60 mcg)|Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
438448|NCT00572910|P11|Participant Flow|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
438449|NCT00572910|P10|Participant Flow|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
438450|NCT00572910|P9|Participant Flow|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
438451|NCT00572910|P8|Participant Flow|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
438452|NCT00572910|P7|Participant Flow|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
438453|NCT00572910|P6|Participant Flow|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg /PBO) with MAA.
438454|NCT00572910|P5|Participant Flow|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
438455|NCT00572910|P4|Participant Flow|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
438456|NCT00572910|P3|Participant Flow|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
438457|NCT00572910|P2|Participant Flow|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
438458|NCT00572910|P1|Participant Flow|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
438459|NCT00572910|O11|Outcome|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
438460|NCT00572910|O10|Outcome|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
438461|NCT00572910|O9|Outcome|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
438462|NCT00572910|O8|Outcome|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
438463|NCT00572910|O7|Outcome|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
438464|NCT00572910|O6|Outcome|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
438465|NCT00572910|O5|Outcome|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
438466|NCT00572910|O4|Outcome|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
438467|NCT00572910|O3|Outcome|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
438468|NCT00572910|O2|Outcome|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
438469|NCT00572910|O1|Outcome|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
438470|NCT00572910|O11|Outcome|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
438471|NCT00572910|O10|Outcome|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
438472|NCT00572910|O9|Outcome|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
438473|NCT00572910|O8|Outcome|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
438474|NCT00572910|O7|Outcome|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
438475|NCT00572910|O6|Outcome|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
438476|NCT00572910|O5|Outcome|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
438862|NCT00583713|B2|Baseline|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
438477|NCT00572910|O4|Outcome|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
438478|NCT00572910|O3|Outcome|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
438479|NCT00572910|O2|Outcome|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
438480|NCT00572910|O1|Outcome|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
438481|NCT00572910|O2|Outcome|V710 - Group 4|Participants in Group 4 were vaccinated V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
438482|NCT00572910|O1|Outcome|V710 - Group 2|Participants in Group 2 were vaccinated V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
438483|NCT00572910|O3|Outcome|V710 - Group 5|Participants in Group 5 were vaccinated V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
438484|NCT00572910|O2|Outcome|V710 - Group 3|Participants in Group 2 were vaccinated V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
438485|NCT00572910|O1|Outcome|V710 - Group 1|Participants in Group 1 were vaccinated V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
438486|NCT00572910|O3|Outcome|V710 - Group 5|Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
438487|NCT00572910|O2|Outcome|V710 - Group 3 and 4|"Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Participants in Group 4 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180."
438488|NCT00572910|O1|Outcome|V710 - Group 1 and 2|"Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Participants Group 2 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180."
438489|NCT00572910|O3|Outcome|V710 (90 mcg With MAA) - Group 5|Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
438490|NCT00572910|O2|Outcome|V710 (60 mcg With MAA) - Group 3|Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
438491|NCT00572910|O1|Outcome|V710 (60 mcg Without MAA) - Group 1|Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
438492|NCT00572910|E11|Reported Event|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
438493|NCT00572910|E10|Reported Event|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
438494|NCT00572910|E9|Reported Event|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
438495|NCT00572910|E8|Reported Event|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
438496|NCT00572910|E7|Reported Event|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
438497|NCT00572910|E6|Reported Event|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
438498|NCT00572910|E5|Reported Event|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
438499|NCT00572910|E4|Reported Event|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
438500|NCT00572910|E3|Reported Event|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
438501|NCT00572910|E2|Reported Event|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
438502|NCT00572910|E1|Reported Event|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
438503|NCT00573066|B1|Baseline|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.
Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
438504|NCT00573066|P1|Participant Flow|Dexmedetomidine Dose Escalation Cohorts|"Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.
Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
438505|NCT00573066|O1|Outcome|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.
Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
438506|NCT00573066|E1|Reported Event|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.
Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
438507|NCT00581529|B1|Baseline|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
438508|NCT00581529|P1|Participant Flow|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
438509|NCT00581529|O1|Outcome|Radiotherapy|"Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy."
438510|NCT00581529|O1|Outcome|Radiotherapy|"Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy."
438511|NCT00581529|E1|Reported Event|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
438512|NCT00581542|B3|Baseline|Total|Total of all reporting groups
438513|NCT00581542|B2|Baseline|Moxifloxacin Ophthalmic Solution|randomization to topical moxifloxacin
438514|NCT00581542|B1|Baseline|Polytrim Ophthalmic Solution|randomization to topical polytrim
438515|NCT00581542|P2|Participant Flow|Moxifloxin Group|Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
438516|NCT00581542|P1|Participant Flow|Polytrim Group|Randomization to polytrim : 1-2 drops four times a day for 8-10 days.
438517|NCT00581542|O2|Outcome|Polytrim Group|Randomization to polytrim : 1-2 drops four times a day for 8-10 days.
438518|NCT00581542|O1|Outcome|Moxifloxin Group|Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
438519|NCT00581542|O2|Outcome|Moxifloxacin|
438520|NCT00581542|O1|Outcome|Polytrim Arm|
438521|NCT00581542|E2|Reported Event|Polytrim Treatment Group|
438522|NCT00581542|E1|Reported Event|Moxifloxacin Treatment Group|
438523|NCT00581555|B3|Baseline|Total|Total of all reporting groups
438524|NCT00581555|B2|Baseline|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438525|NCT00581555|B1|Baseline|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438526|NCT00581555|P2|Participant Flow|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438527|NCT00581555|P1|Participant Flow|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438528|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438529|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438530|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438531|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438532|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438533|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438534|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438535|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438536|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438537|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438538|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438539|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438540|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438541|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438542|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438543|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438544|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438545|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438546|NCT00581555|E2|Reported Event|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
438547|NCT00581555|E1|Reported Event|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
438548|NCT00581581|B3|Baseline|Total|Total of all reporting groups
438549|NCT00581581|B2|Baseline|Standard Care|Randomized to standard care (original RCT)
438550|NCT00581581|B1|Baseline|Therapeutic Hypothermia|Randomized to cooling (original RCT)
438551|NCT00581581|P2|Participant Flow|Standard Care|Randomized to standard care (original RCT)
438552|NCT00581581|P1|Participant Flow|Therapeutic Hypothermia|Randomized to cooling (original RCT)
438553|NCT00581581|O2|Outcome|Standard Care|Randomized to standard care (original RCT)
438554|NCT00581581|O1|Outcome|Therapeutic Hypothermia|Randomized to cooling (original RCT)
438555|NCT00581581|E2|Reported Event|Standard Care|Randomized to standard care (original RCT)
438556|NCT00581581|E1|Reported Event|Therapeutic Hypothermia|Randomized to cooling (original RCT)
438557|NCT00581776|B1|Baseline|VCR-CVAD With Rituximab Maintenance|
438558|NCT00581776|P1|Participant Flow|VCR-CVAD With Rituximab Maintenance|
438559|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
438560|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
438561|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
438562|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
438563|NCT00581776|E1|Reported Event|VCR-CVAD With Rituximab Maintenance|
438564|NCT00581828|B1|Baseline|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
438565|NCT00581828|P1|Participant Flow|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
438566|NCT00581828|O1|Outcome|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
438567|NCT00581828|E1|Reported Event|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
438568|NCT00581854|B1|Baseline|Group 1|SAEs during induction therapy
438569|NCT00581854|P1|Participant Flow|Rituximab|Single Arm Maintenance rituximab following induction chemoimmunotherapy
438570|NCT00581854|O1|Outcome|Group 1|All subjects received R-HyperCVAD induction therapy.
438571|NCT00581854|E1|Reported Event|Group 1|SAEs during induction therapy
438572|NCT00582491|B3|Baseline|Total|Total of all reporting groups
438573|NCT00582491|B2|Baseline|Placebo|Participants received a single oral placebo every morning for 16 days
438574|NCT00582491|B1|Baseline|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
438575|NCT00582491|P2|Participant Flow|Placebo|Placebo orally everyday for 16 days
438576|NCT00582491|P1|Participant Flow|Modafinil 400mg|Modafinil 400mg orally everyday for 16 days
438577|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
438578|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
438579|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
438580|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
438581|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
438582|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
438583|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
438584|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
438585|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
438586|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
438587|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
438588|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
438589|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
438590|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
438591|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
438592|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
438593|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
438594|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
438595|NCT00582491|E2|Reported Event|Placebo|Participants received a single oral placebo every morning for 16 days
438596|NCT00582491|E1|Reported Event|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
438597|NCT00582517|B3|Baseline|Total|Total of all reporting groups
438598|NCT00582517|B2|Baseline|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
438599|NCT00582517|B1|Baseline|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
438600|NCT00582517|P2|Participant Flow|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
438601|NCT00582517|P1|Participant Flow|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
438602|NCT00582517|O2|Outcome|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed. Stability of the knee determined by Continuous Passive Motion (CPM) machines and range of motion reached.
438603|NCT00582517|O1|Outcome|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery. Stability of the knee determined by Continuous Passive Motion (CPM) machines and range of motion reached.
438604|NCT00582517|E2|Reported Event|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
438605|NCT00582517|E1|Reported Event|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
438606|NCT00582556|B4|Baseline|Total|Total of all reporting groups
438607|NCT00582556|B3|Baseline|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
438608|NCT00582556|B2|Baseline|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
438609|NCT00582556|B1|Baseline|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
438610|NCT00582556|P3|Participant Flow|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
438611|NCT00582556|P2|Participant Flow|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
438612|NCT00582556|P1|Participant Flow|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
438863|NCT00583713|B1|Baseline|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
438613|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
438614|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
438615|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|Gonadotropin releasing hormone (GnRH) analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
438616|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
438617|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
438618|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
438619|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
438620|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
438621|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
438622|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
438623|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
438624|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
438625|NCT00582556|E3|Reported Event|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
438626|NCT00582556|E2|Reported Event|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
438627|NCT00582556|E1|Reported Event|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
438628|NCT00582608|B1|Baseline|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
438629|NCT00582608|P1|Participant Flow|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
438630|NCT00582608|O1|Outcome|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
438631|NCT00582608|E1|Reported Event|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
438632|NCT00582660|B3|Baseline|Total|Total of all reporting groups
438633|NCT00582660|B2|Baseline|Placebo|1 tablet BID given for 7 days before surgery
438634|NCT00582660|B1|Baseline|Celecoxib|400 mg BID given for 7 days before surgery
438635|NCT00582660|P2|Participant Flow|Placebo|1 tablet BID given for 7 days before surgery
438636|NCT00582660|P1|Participant Flow|Celecoxib|400 mg BID given for 7 days before surgery
438637|NCT00582660|O2|Outcome|Placebo|1 tablet BID given for 7 days before surgery
438638|NCT00582660|O1|Outcome|Celecoxib|400 mg BID given for 7 days before surgery
438639|NCT00582660|O2|Outcome|Placebo|1 tablet BID given for 7 days before surgery
438640|NCT00582660|O1|Outcome|Celecoxib|400 mg BID given for 7 days before surgery
438641|NCT00582660|E2|Reported Event|Placebo|1 tablet BID given for 7 days before surgery
438642|NCT00582660|E1|Reported Event|Celecoxib|400 mg BID given for 7 days before surgery
438643|NCT00582712|B1|Baseline|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
438644|NCT00582712|P1|Participant Flow|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
438645|NCT00582712|O1|Outcome|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
438646|NCT00582712|E1|Reported Event|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
438647|NCT00582738|B3|Baseline|Total|Total of all reporting groups
438648|NCT00582738|B2|Baseline|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438649|NCT00582738|B1|Baseline|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438650|NCT00582738|P2|Participant Flow|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438651|NCT00582738|P1|Participant Flow|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438652|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438653|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438654|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438655|NCT00582738|O1|Outcome|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438656|NCT00582738|O4|Outcome|Everolimus - Summary of Fibrotest by Treatment|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438657|NCT00582738|O3|Outcome|Standard Treatment -Summary of Fibrotest by Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438658|NCT00582738|O2|Outcome|Everolimus -Summary of Actitest by Treatment|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438659|NCT00582738|O1|Outcome|Standard Treatment - Summary of Actitest by Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438660|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438661|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438662|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438663|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438664|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438665|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438666|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438667|NCT00582738|O1|Outcome|CsA/TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438668|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438669|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438670|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438671|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
438672|NCT00582738|E2|Reported Event|EVR (Everolimus)|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
438673|NCT00582738|E1|Reported Event|CsA/TAC|Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) / no everolimus introduction.
438674|NCT00582790|B1|Baseline|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.
patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.
The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
438675|NCT00582790|P1|Participant Flow|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.
patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.
The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
438676|NCT00582790|O1|Outcome|Low-dose IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.
patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.
The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
438677|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.
patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.
The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
438699|NCT00582907|P4|Participant Flow|Placebo-Rilonacept-Rilonacept-Placebo|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
438864|NCT00583713|P3|Participant Flow|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
438678|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.
patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.
The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
438679|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.
patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.
The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
438680|NCT00582790|E1|Reported Event|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.
patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.
The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
438681|NCT00582816|B1|Baseline|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.
Clinimacs Cell Separation System: Depletion of T-cells"
438682|NCT00582816|P1|Participant Flow|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.
Clinimacs Cell Separation System: Depletion of T-cells"
438683|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.
Clinimacs Cell Separation System: Depletion of T-cells"
438684|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.
Clinimacs Cell Separation System: Depletion of T-cells"
438685|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.
Clinimacs Cell Separation System: Depletion of T-cells"
438700|NCT00582907|P3|Participant Flow|Placebo-Rilonacept-Placebo-Rilonacept|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
438701|NCT00582907|P2|Participant Flow|Rilonacept-Placebo-Placebo-Rilonacept|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine. Overall study was 12 months.
438865|NCT00583713|P2|Participant Flow|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
442757|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
438686|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.
Clinimacs Cell Separation System: Depletion of T-cells"
438687|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.
Clinimacs Cell Separation System: Depletion of T-cells"
438688|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.
Clinimacs Cell Separation System: Depletion of T-cells"
438689|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.
Clinimacs Cell Separation System: Depletion of T-cells"
438690|NCT00582816|E1|Reported Event|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.
Clinimacs Cell Separation System: Depletion of T-cells"
438691|NCT00582894|B1|Baseline|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
438692|NCT00582894|P1|Participant Flow|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
438693|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
438694|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
438695|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
438696|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
438697|NCT00582894|E1|Reported Event|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
438698|NCT00582907|B1|Baseline|All Patients Received Both Rilonacept and Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
442758|NCT00594425|O3|Outcome|Vehicle PDT|
438702|NCT00582907|P1|Participant Flow|Rilonacept-Placebo-Rilonacept-Placebo|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine. Overall study was 12 months.
438703|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438704|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438705|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438706|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438707|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438708|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438709|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438710|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438711|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438712|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438713|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438714|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438749|NCT00583115|O1|Outcome|Gleevec|"Drug taken orally 260mg/M2/day once per day
Gleevec: 260 mg/M2/day, given once daily by mouth"
438750|NCT00583115|E1|Reported Event|Gleevec|"Drug taken orally 260mg/M2/day once per day
Gleevec: 260 mg/M2/day, given once daily by mouth"
438715|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438716|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438717|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438718|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438719|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438720|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438721|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438722|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438723|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438724|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438725|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438726|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438727|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438866|NCT00583713|P1|Participant Flow|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
438728|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438729|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438730|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.
Overall length of study for each participant is 12 months."
438731|NCT00582907|E2|Reported Event|Rilonacept|"Adverse events during rilonacept treatment. Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo."
438732|NCT00582907|E1|Reported Event|Placebo|"Adverse events during placebo treatment. Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
Patients were randomized to 4 treatment sequences:
1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo."
438733|NCT00582933|B1|Baseline|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
438734|NCT00582933|P1|Participant Flow|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
438735|NCT00582933|O1|Outcome|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
438736|NCT00582933|E1|Reported Event|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
438737|NCT00582946|B1|Baseline|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
438738|NCT00582946|P1|Participant Flow|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
438739|NCT00582946|O1|Outcome|Maximum Equivalent Pressure Output|Provision of amplification to treat sensorineural hearing loss with direct-drive hearing aid for acute evaluation of efficacy.
438740|NCT00582946|E1|Reported Event|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
438741|NCT00582972|B1|Baseline|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
438742|NCT00582972|P1|Participant Flow|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
438743|NCT00582972|O1|Outcome|Experimental|Subjects received omeprazole 40 mg daily for 30 days
438744|NCT00582972|O1|Outcome|Experimental|omeprazole 40 mg daily for 30 days
438745|NCT00582972|E1|Reported Event|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
438746|NCT00583115|B1|Baseline|Gleevec|"Drug taken orally 260mg/M2/day once per day
Gleevec: 260 mg/M2/day, given once daily by mouth"
438747|NCT00583115|P1|Participant Flow|Gleevec|"Drug taken orally 260mg/M2/day once per day
Gleevec: 260 mg/M2/day, given once daily by mouth"
438748|NCT00583115|O1|Outcome|Gleevec|"Drug taken orally 260mg/M2/day once per day
Gleevec: 260 mg/M2/day, given once daily by mouth"
438868|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
438751|NCT00583219|B1|Baseline|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438752|NCT00583219|P1|Participant Flow|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438753|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438754|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438755|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438756|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438757|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438758|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438767|NCT00583219|E1|Reported Event|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438759|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438760|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438761|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438762|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438763|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438764|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438765|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438766|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.
Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
438768|NCT00583362|B1|Baseline|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438867|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
438769|NCT00583362|P1|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438770|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438771|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438772|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438773|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438774|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438775|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438776|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438777|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438778|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438779|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438780|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438781|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438799|NCT00583453|O2|Outcome|Placebo With Same Dosing Schedule as the Active Comparator Arm|"Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438782|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438783|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438784|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438785|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438786|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438787|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438788|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438789|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438790|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438791|NCT00583362|E1|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
438792|NCT00583453|B3|Baseline|Total|Total of all reporting groups
438793|NCT00583453|B2|Baseline|Placebo With Same Dosing Schedule as the Active Comparator Arm|"Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438794|NCT00583453|B1|Baseline|Celecoxib 200 mg Tablets|"Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438795|NCT00583453|P2|Participant Flow|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438796|NCT00583453|P1|Participant Flow|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438797|NCT00583453|O2|Outcome|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438798|NCT00583453|O1|Outcome|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438800|NCT00583453|O1|Outcome|Celecoxib 200 mg Tablets|"Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438801|NCT00583453|O2|Outcome|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438802|NCT00583453|O1|Outcome|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438803|NCT00583453|O2|Outcome|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438804|NCT00583453|O1|Outcome|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438805|NCT00583453|O2|Outcome|Placebo With Same Dosing Schedule as the Active Comparator Arm|"Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438806|NCT00583453|O1|Outcome|Celecoxib 200 mg Tablets|"Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438807|NCT00583453|E2|Reported Event|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438808|NCT00583453|E1|Reported Event|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
capsule the night before surgery
capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery"
438809|NCT00583492|B3|Baseline|Total|Total of all reporting groups
438810|NCT00583492|B2|Baseline|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
438811|NCT00583492|B1|Baseline|Gene Therapy + IMRT|"Gene Therapy + IMRT
Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
438812|NCT00583492|P2|Participant Flow|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
438813|NCT00583492|P1|Participant Flow|Gene Therapy + IMRT|"Gene Therapy + IMRT
Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
438814|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
438815|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT
Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
438816|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
438817|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT
Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
438818|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
438819|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT
Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
438820|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
438821|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT
Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
438822|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
438823|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT
Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
438824|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
438825|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT
Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
438860|NCT00583713|B4|Baseline|Total|Total of all reporting groups
438861|NCT00583713|B3|Baseline|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
438826|NCT00583492|E2|Reported Event|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
438827|NCT00583492|E1|Reported Event|Gene Therapy + IMRT|"Gene Therapy + IMRT
Ad5-yCD/mutTKSR39rep-ADP: 1 x 10^12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
438828|NCT00583557|B1|Baseline|Belimumab 10 mg/kg|
438829|NCT00583557|P1|Participant Flow|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
438830|NCT00583557|O1|Outcome|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
438831|NCT00583557|E1|Reported Event|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
438832|NCT00583596|B1|Baseline|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
438833|NCT00583596|P1|Participant Flow|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
438834|NCT00583596|O1|Outcome|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
438835|NCT00583596|O1|Outcome|Long Term Follow-up for Subjects Implanted With the Device|Subjects implanted with Amplatzer duct occluder that have final follow-up taking place 5 yrs., 6 yrs., or 7 yrs., post implant.
438836|NCT00583596|E1|Reported Event|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
438837|NCT00583622|B1|Baseline|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
438838|NCT00583622|P1|Participant Flow|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
438839|NCT00583622|O1|Outcome|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
438840|NCT00583622|O1|Outcome|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
438841|NCT00583622|E1|Reported Event|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
438842|NCT00583661|B1|Baseline|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
438843|NCT00583661|P1|Participant Flow|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
438844|NCT00583661|O2|Outcome|Cohort 2|Subjects with Body Surface Area 0.7-1.5m^2
438845|NCT00583661|O1|Outcome|Cohort 1|Subjects with Body Surface Area < 0.7m^2
438846|NCT00583661|O2|Outcome|Cohort 2|Subjects with Body Surface Area 0.7-1.5m^2
438847|NCT00583661|O1|Outcome|Cohort 1|Subjects with Body Surface Area < 0.7m^2
438848|NCT00583661|E1|Reported Event|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
438849|NCT00583700|B3|Baseline|Total|Total of all reporting groups
438850|NCT00583700|B2|Baseline|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.
Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily
Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
438851|NCT00583700|B1|Baseline|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
438852|NCT00583700|P2|Participant Flow|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.
Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily
Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
438853|NCT00583700|P1|Participant Flow|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
438854|NCT00583700|O2|Outcome|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.
Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily
Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
438855|NCT00583700|O1|Outcome|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
438856|NCT00583700|O2|Outcome|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.
Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily
Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
438857|NCT00583700|O1|Outcome|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
438858|NCT00583700|E2|Reported Event|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.
Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily
Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
438859|NCT00583700|E1|Reported Event|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
438869|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
438870|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
438871|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
438872|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
438873|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
438874|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
438875|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
438876|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
438877|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
438878|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
438879|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
438880|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
438881|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
438882|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
438883|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
438884|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
438885|NCT00583713|E3|Reported Event|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
438886|NCT00583713|E2|Reported Event|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
438887|NCT00583713|E1|Reported Event|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
438888|NCT00583908|B1|Baseline|Overall Study Population|Summary for overall study population
438889|NCT00583908|P12|Participant Flow|Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438890|NCT00583908|P11|Participant Flow|Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438891|NCT00583908|P10|Participant Flow|Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438892|NCT00583908|P9|Participant Flow|Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438893|NCT00583908|P8|Participant Flow|Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438894|NCT00583908|P7|Participant Flow|Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438895|NCT00583908|P6|Participant Flow|Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438896|NCT00583908|P5|Participant Flow|Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438897|NCT00583908|P4|Participant Flow|Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438898|NCT00583908|P3|Participant Flow|Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438899|NCT00583908|P2|Participant Flow|Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438900|NCT00583908|P1|Participant Flow|Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438901|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
438902|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
438903|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
438904|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
438905|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
438906|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
438907|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
438908|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
438909|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
438910|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
438911|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
438912|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
438913|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
438914|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
438915|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
438916|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
438917|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
438918|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
438919|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
438920|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
438921|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
438922|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
438923|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
438924|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
438925|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
438926|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
438927|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
438928|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
438929|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
438930|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
438931|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
438932|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
438933|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
438934|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
438935|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
438936|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
438937|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
438938|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
438939|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
438940|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
438941|NCT00583908|E12|Reported Event|Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438942|NCT00583908|E11|Reported Event|Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438943|NCT00583908|E10|Reported Event|Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438944|NCT00583908|E9|Reported Event|Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438945|NCT00583908|E8|Reported Event|Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438946|NCT00583908|E7|Reported Event|Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438947|NCT00583908|E6|Reported Event|Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438948|NCT00583908|E5|Reported Event|Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438949|NCT00583908|E4|Reported Event|Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438950|NCT00583908|E3|Reported Event|Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438951|NCT00583908|E2|Reported Event|Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438952|NCT00583908|E1|Reported Event|Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
438953|NCT00583947|B3|Baseline|Total|Total of all reporting groups
438954|NCT00583947|B2|Baseline|LEV/ARF|"Cross-over: Participants treated with levalbuterol 0.63 milligram per nebulization; 7 day washout; arformoterol 7.5 microgram per nebulization.
Open label: 7 day washout; arformoterol 15 microgram per nebulization."
438955|NCT00583947|B1|Baseline|ARF/LEV|"Cross-over: Participants treated with arformoterol 7.5 microgram per nebulization; 7 day washout; levalbuterol 0.63 milligram per nebulization.
Open label: 7 day washout; arformoterol 15 microgram per nebulization."
438956|NCT00583947|P2|Participant Flow|LEV/ARF|"Cross-over period: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.
Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization."
438957|NCT00583947|P1|Participant Flow|ARF/LEV|"Cross-over period: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.
Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization."
438958|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
439021|NCT00584220|O2|Outcome|Alphafilcon A Toric|contact lenses
438959|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438960|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438961|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438962|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438963|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438964|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438965|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438966|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438967|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438968|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438969|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438970|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438971|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438972|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438973|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438974|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438975|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438976|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438977|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438978|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438979|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438980|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438981|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438982|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438983|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438984|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438985|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438986|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438987|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438988|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438989|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438990|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438991|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438992|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438993|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438994|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
438995|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438996|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
438997|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
439022|NCT00584220|O1|Outcome|Senofilcon A Toric|contact lenses
438998|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
438999|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
439000|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
439001|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
439002|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
439003|NCT00583947|E3|Reported Event|Arformoterol 15 Mcg|The experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study.
439004|NCT00583947|E2|Reported Event|Arformoterol 7.5 Mcg|The experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study.
439005|NCT00583947|E1|Reported Event|Levalbuterol 0.63 mg|The experience of participants when treated with levalbuterol during the cross-over portion of the study.
439006|NCT00584077|B1|Baseline|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
439007|NCT00584077|P1|Participant Flow|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
439008|NCT00584077|O1|Outcome|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
439009|NCT00584077|E1|Reported Event|Lung Transplant Recipients With Stable Lung Function|Enrolled subjects underwent bronchoscopy to assess for presence of cough reflex in the transpalnted and non-transplanted lung
439010|NCT00584194|B1|Baseline|TSI-GSD 200 RVF Vaccine|"Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
TSI-GSD 200 RVF Vaccine: Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40."
439011|NCT00584194|P1|Participant Flow|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
439012|NCT00584194|O1|Outcome|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
439013|NCT00584194|O1|Outcome|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
439014|NCT00584194|O1|Outcome|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
439015|NCT00584194|O1|Outcome|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
439016|NCT00584194|O1|Outcome|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
439017|NCT00584194|E1|Reported Event|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
439018|NCT00584220|B1|Baseline|All Subjects|Subjects who enrolled and completed the study.
439019|NCT00584220|P2|Participant Flow|Alphafilcon A / Senofilcon A|alphafilcon A toric hydrogel contact lenses worn first, then senofilcon A toric silicone hydrogel contact lenses worn second
439020|NCT00584220|P1|Participant Flow|Senofilcon A / Alphafilcon A|senofilcon A toric silicone hydrogel contact lenses worn first, then alphafilcon A toric hydrogel contact lenses worn second
439025|NCT00584220|E2|Reported Event|Alphafilcon A|alphafilcon A toric hydrogel contact lenses worn
439026|NCT00584220|E1|Reported Event|Senofilcon A|senofilcon A toric silicone hydrogel contact lenses worn
439027|NCT00584402|B1|Baseline|Contrast Sonography|Contrast-enhanced sonography perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
439028|NCT00584402|P1|Participant Flow|Contrast Sonography|"Contrast-enhanced sonography
perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity"
439029|NCT00584402|O1|Outcome|Contrast Sonography|Subjects undergoing contrast sonography
439030|NCT00584402|O1|Outcome|Contrast Sonography|Subjects undergoing contrast sonography
439031|NCT00584402|E1|Reported Event|Contrast Sonography|"Contrast-enhanced sonography
perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity"
439032|NCT00584415|B1|Baseline|PV Isolation + GP Ablation|All patients received pulmonary vein antrum isolation (PV isolation) and ablation of the major atrial ganglionated plexi (superior left GP, inferior left GP, anterior right GP and inferior right GP). Ganglionated plexi (GP) were identified by delivering high-frequency stimulation (20 Hz) from the ablation catheter. If vagal response (AV block) was initiated by stimulation, that site was counted as a GP site and was then ablated.
439033|NCT00584415|P1|Participant Flow|GP Ablation + PV Isolation|All patients in this study received pulmonary vein isolation (PVI) and ganglionated plexi (GP) ablation to treat paroxysmal AF
439034|NCT00584415|O1|Outcome|Experimental Arm (GP Ablation + PV Antrum Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
439035|NCT00584415|O1|Outcome|GP Ablation + PV Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
439036|NCT00584415|E1|Reported Event|Experimental Arm (GP Ablation + PV Antrum Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
439037|NCT00584454|B1|Baseline|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.
Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
439038|NCT00584454|P1|Participant Flow|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.
Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
439039|NCT00584454|O1|Outcome|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.
Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
439040|NCT00584454|E1|Reported Event|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.
Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
439041|NCT00584480|B1|Baseline|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
439042|NCT00584480|P1|Participant Flow|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
439043|NCT00584480|O1|Outcome|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
439088|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
439089|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
439044|NCT00584480|E1|Reported Event|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
439045|NCT00584701|B1|Baseline|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
439046|NCT00584701|P1|Participant Flow|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
439047|NCT00584701|O1|Outcome|Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
439048|NCT00584701|O1|Outcome|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
439049|NCT00584701|E1|Reported Event|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
439050|NCT00584727|B1|Baseline|Completed Population|Only participants that completed the study are included (n=88)
439051|NCT00584727|P6|Participant Flow|Etafilcon A/Alphafilcon A/Senofilcon A|First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
439052|NCT00584727|P5|Participant Flow|Alphafilcon A/Senofilcon A/Etafilcon A|First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
439053|NCT00584727|P4|Participant Flow|Senofilcon A/Etafilcon A/Alphafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
439054|NCT00584727|P3|Participant Flow|Etafilcon A/Senofilcon A/Alphafilcon A|First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
439055|NCT00584727|P2|Participant Flow|Alphafilcon A/Etafilcon A/Senofilcon A|First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
439056|NCT00584727|P1|Participant Flow|Senofilcon A/Alphafilcon A/Etafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
439057|NCT00584727|O3|Outcome|Etafilcon A Sphere|
439058|NCT00584727|O2|Outcome|Alphafilcon A Toric|
439059|NCT00584727|O1|Outcome|Senofilcon A Toric|
439060|NCT00584727|O3|Outcome|Etafilcon A Sphere|
439061|NCT00584727|O2|Outcome|Alphafilcon A Toric|
439062|NCT00584727|O1|Outcome|Senofilcon A Toric|
439063|NCT00584727|O2|Outcome|Alphafilcon A Toric|
439064|NCT00584727|O1|Outcome|Senofilcon A Toric|
439065|NCT00584727|O2|Outcome|Alphafilcon A Toric|
439066|NCT00584727|O1|Outcome|Senofilcon A Toric|
439067|NCT00584727|O3|Outcome|Etafilcon A Sphere|
439068|NCT00584727|O2|Outcome|Alphafilcon A Toric|
439069|NCT00584727|O1|Outcome|Senofilcon A Toric|
439070|NCT00584727|O3|Outcome|Etafilcon A Sphere|
439071|NCT00584727|O2|Outcome|Alphafilcon A Toric|
439072|NCT00584727|O1|Outcome|Senofilcon A Toric|
439073|NCT00584727|E6|Reported Event|Etafilcon A/Alphafilcon A/Senofilcon A|First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
439074|NCT00584727|E5|Reported Event|Alphafilcon A/Senofilcon A/Etafilcon A|First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
439075|NCT00584727|E4|Reported Event|Senofilcon A/Etafilcon A/Alphafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
439076|NCT00584727|E3|Reported Event|Etafilcon A/Senofilcon A/Alphafilcon A|First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
439077|NCT00584727|E2|Reported Event|Alphafilcon A/Etafilcon A/Senofilcon A|First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
439078|NCT00584727|E1|Reported Event|Senofilcon A/Alphafilcon A/Etafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
439079|NCT00584740|B3|Baseline|Total|Total of all reporting groups
439080|NCT00584740|B2|Baseline|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
439081|NCT00584740|B1|Baseline|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
439082|NCT00584740|P2|Participant Flow|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
439083|NCT00584740|P1|Participant Flow|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
439084|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
439085|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
439086|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
439087|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
442759|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
439090|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
439091|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
439092|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
439093|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
439094|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
439095|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
439096|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
439097|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
439098|NCT00584740|E2|Reported Event|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
439099|NCT00584740|E1|Reported Event|AIN457 Twice 10mg/kg|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
439100|NCT00584831|B1|Baseline|Total Study Population|
439101|NCT00584831|P19|Participant Flow|Group 17 BSOL|balafilcon A toric, senofilcon A toric,omafilcon A toric, lotrafilcon b toric
439102|NCT00584831|P18|Participant Flow|Group 6 SLOB|senofilcon A toric, lotrafilcon b toric, omafilcon A toric, balafilcon A toric
439103|NCT00584831|P17|Participant Flow|Group 3 LOSB|lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
439104|NCT00584831|P16|Participant Flow|Group 19 BOSL|balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
439105|NCT00584831|P15|Participant Flow|Group 18 BOLS|balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
439106|NCT00584831|P14|Participant Flow|Group 16 BLOS|balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
439107|NCT00584831|P13|Participant Flow|Group 15 BLSO|balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
439108|NCT00584831|P12|Participant Flow|Group 14 OBSL|omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
439109|NCT00584831|P11|Participant Flow|Group 13 OBLS|omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
439110|NCT00584831|P10|Participant Flow|Group 12 OSBL|omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
439111|NCT00584831|P9|Participant Flow|Group 11 OSLB|omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
439112|NCT00584831|P8|Participant Flow|Group 10 SBOL|senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
439113|NCT00584831|P7|Participant Flow|Group 9 SBLO|senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
439114|NCT00584831|P6|Participant Flow|Group 8 SOLB|senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
439115|NCT00584831|P5|Participant Flow|Group 7 SLBO|senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
439116|NCT00584831|P4|Participant Flow|Group 5 LBOS|lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
439117|NCT00584831|P3|Participant Flow|Group 4 LBSO|lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
439118|NCT00584831|P2|Participant Flow|Group 2 LSBO|lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
439119|NCT00584831|P1|Participant Flow|Group1 LSOB|lotrafilcon b toric, senofilcon A toric, omafilcon A toric, balafilcon A toric
439120|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
439121|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
439122|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
439123|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
439124|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
439125|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
439126|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
439127|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
439128|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
439129|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
439130|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
439131|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
439132|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
439133|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
439134|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
439135|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
439136|NCT00584831|E4|Reported Event|Balafilcon A|balafilcon A toric contact lens
439137|NCT00584831|E3|Reported Event|Omafilcon A|omafilcon A toric contact lens
439138|NCT00584831|E2|Reported Event|Senofilcon A|senofilcon A toric contact lens
439139|NCT00584831|E1|Reported Event|Lotrafilcon B|lotrafilcon b toric contact lens
439140|NCT00584844|B1|Baseline|F Tularensis Vaccine (0.0025 mL)|"Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.
Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20)."
439141|NCT00584844|P1|Participant Flow|F Tularensis Vaccine (0.0025 mL)|"Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.
Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20)."
439142|NCT00584844|O1|Outcome|Percent of Subjects|Percentage of subjects in specific category
439143|NCT00584844|O1|Outcome|Percent of Subjects|Percentage of subjects in specific category
439144|NCT00584844|O1|Outcome|Percent of Subjects|Percentage of subjects in specific category
439145|NCT00584844|O2|Outcome|Females|All females in study
439146|NCT00584844|O1|Outcome|Males|All males in study
439147|NCT00584844|E3|Reported Event|Severe|Severe
439148|NCT00584844|E2|Reported Event|Moderate|Moderate
439149|NCT00584844|E1|Reported Event|Mild|Mild
439150|NCT00584857|B1|Baseline|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
439151|NCT00584857|P1|Participant Flow|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
439152|NCT00584857|O1|Outcome|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
439153|NCT00584857|O1|Outcome|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
439154|NCT00584857|E1|Reported Event|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
439155|NCT00584909|B1|Baseline|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
439156|NCT00584909|P1|Participant Flow|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
439157|NCT00584909|O1|Outcome|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
439158|NCT00584909|O1|Outcome|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
439159|NCT00584909|E1|Reported Event|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
439160|NCT00584935|B1|Baseline|Rituximab|
439161|NCT00584935|P1|Participant Flow|Rituximab|
439162|NCT00584935|O1|Outcome|Rituximab|
439163|NCT00584935|E1|Reported Event|Rituximab|
439164|NCT00584948|B3|Baseline|Total|Total of all reporting groups
439165|NCT00584948|B2|Baseline|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
439166|NCT00584948|B1|Baseline|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
439167|NCT00584948|P2|Participant Flow|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
439168|NCT00584948|P1|Participant Flow|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
439169|NCT00584948|O2|Outcome|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
439170|NCT00584948|O1|Outcome|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
439171|NCT00584948|O2|Outcome|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
439172|NCT00584948|O1|Outcome|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
439173|NCT00584948|E2|Reported Event|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
442760|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
439174|NCT00584948|E1|Reported Event|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
439175|NCT00576472|B16|Baseline|Total|Total of all reporting groups
439176|NCT00576472|B15|Baseline|Home Maintenance Phase|Methylphenidate (MPH) was administered for 12 months during the duration of the Home Maintenance Phase.
439177|NCT00576472|B14|Baseline|Declined Home Maintenance Phase|Patients who completed the MPH Cross Over Phase but chose to decline participation in the Home Maintenance Phase.
439178|NCT00576472|B13|Baseline|Moderate Dose/Placebo/Low Dose (MPL)|The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
439179|NCT00576472|B12|Baseline|Moderate Dose/Low Dose/Placebo (MLP)|The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
439180|NCT00576472|B11|Baseline|Low Dose/Placebo/Moderate Dose (LPM)|The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
439181|NCT00576472|B10|Baseline|Low Dose/Moderate Dose/ Placebo (LMP)|The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
439182|NCT00576472|B9|Baseline|Placebo/Moderate Dose/Low Dose (PML)|The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a lose dose of Methylphenidate (MPH) on week three.
439183|NCT00576472|B8|Baseline|Placebo/Low Dose/Moderate Dose (PLM)|The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
439184|NCT00576472|B7|Baseline|Not Randomized-Cross Over|Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross Over Phase
439185|NCT00576472|B6|Baseline|Group P/M|Group P/M (patients receive oral placebo and ten Methylphenidate (MPH))
439186|NCT00576472|B5|Baseline|Group M/P|Group M/P (patients receive oral Methylphenidate (MPH) and then an oral placebo)
439187|NCT00576472|B4|Baseline|Not Randomized-In Lab Phase|Patients not randomized for the MPH in Lab Phase
439188|NCT00576472|B3|Baseline|High|Intensity of prior Central Nervous System radiation therapy was considered high.
439189|NCT00576472|B2|Baseline|Moderate|Intensity of prior Central Nervous System radiation therapy was considered moderate.
439190|NCT00576472|B1|Baseline|Mild|Intensity of prior Central Nervous System radiation therapy was considered mild.
439191|NCT00576472|P15|Participant Flow|Methylphenidate (MPH) Home Maintenance Phase|Methylphenidate (MPH) was administered for 12 months during the Methylphenidate (MPH) Home Maintenance Phase.
439192|NCT00576472|P14|Participant Flow|Declined Methylphenidate (MPH) Home Maintenance Phase|Patients who completed the Methylphenidate (MPH) Cross Over Phase but chose to decline participation in the Methylphenidate (MPH) Home Maintenance Phase.
439193|NCT00576472|P13|Participant Flow|Moderate Dose/Placebo/Low Dose (MPL)|The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
439194|NCT00576472|P12|Participant Flow|Moderate Dose/Low Dose/Placebo (MLP)|The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
439195|NCT00576472|P11|Participant Flow|Low Dose/Placebo/Moderate Dose (LPM)|The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
439196|NCT00576472|P10|Participant Flow|Low Dose/Moderate Dose/ Placebo (LMP)|The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
439197|NCT00576472|P9|Participant Flow|Placebo/Moderate Dose/Low Dose (PML)|The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a low dose of Methylphenidate (MPH) on week three.
439198|NCT00576472|P8|Participant Flow|Placebo/Low Dose/Moderate Dose (PLM)|The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
439199|NCT00576472|P7|Participant Flow|Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase|Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross-Over Phase
439200|NCT00576472|P6|Participant Flow|Group P/M|Group P/M (patients received oral placebo and then Methylphenidate (MPH))
439201|NCT00576472|P5|Participant Flow|Group M/P|Group M/P (patients received oral Methylphenidate (MPH) and then an oral placebo)
439202|NCT00576472|P4|Participant Flow|Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase.
439203|NCT00576472|P3|Participant Flow|High Intensity|Intensity of prior CNS Therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy) classified as high.
439204|NCT00576472|P2|Participant Flow|Moderate Intensity|Intensity of prior CNS Therapy (< 24 Gy CRT with or without systemic and/or intrathecal chemotherapy)classified as moderate.
439205|NCT00576472|P1|Participant Flow|Mild Intensity|Intensity of prior CNS Therapy (systemic and/or intrathecal chemotherapy only)classified as mild.
439206|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439285|NCT00576472|O2|Outcome|Mild Treatment Intensity|Mildly intense central nervous system therapy (systemic and/or intrathecal chemotherapy only)
439286|NCT00576472|O1|Outcome|Siblings|The sibling control group received no radiation therapy.
439287|NCT00576472|O2|Outcome|Patients With Brain Tumors|Patients with brain tumors who had evaluable MRIs.
439207|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439208|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439209|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439210|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439211|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439212|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439213|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439214|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439215|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439216|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439217|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439218|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439288|NCT00576472|O1|Outcome|Patients With ALL|Patients with Acute Lymphoblastic Leukemia (ALL) who had evaluable MRIs.
439289|NCT00576472|O2|Outcome|Siblings|Sibling controls with evaluable MRIs.
442761|NCT00594425|O3|Outcome|Vehicle PDT|
439219|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439220|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439221|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439222|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439223|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439224|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439225|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439226|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439227|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439228|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439229|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439230|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439290|NCT00576472|O1|Outcome|Patients|Patients with evaluable MRIs.
439291|NCT00576472|E3|Reported Event|High|Intensity of prior Central Nervous System radiation therapy was considered high.
439231|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439232|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439233|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439234|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439235|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439236|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439237|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439238|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439239|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439240|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439241|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
439242|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439292|NCT00576472|E2|Reported Event|Moderate|Intensity of prior Central Nervous System radiation therapy was considered moderate.
439293|NCT00576472|E1|Reported Event|Mild|Intensity of prior Central Nervous System radiation therapy was considered mild.
439243|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439244|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439245|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439246|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439247|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439248|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439249|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439250|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439251|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439252|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439253|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439265|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439254|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439255|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439256|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439257|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439258|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439259|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439260|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439261|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439262|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439263|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439264|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439282|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Questionnaire and 59 were screen at completion. 47 patients were screened at both the beginning and end of the home maintenance phase.
439283|NCT00576472|O4|Outcome|High Treatment Intensity|High intensity central nervous system therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy.
439294|NCT00576524|B3|Baseline|Total|Total of all reporting groups
439266|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439267|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439268|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439269|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439270|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439271|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
439272|NCT00576472|O3|Outcome|Moderate Dose|Patients assigned to the Moderate Dose group were randomly assigned to receive one of two arms: Group MLP received moderate dose during week one, low dose during week 2, and placebo during week 3; Group MPL received moderate dose during week one, placebo during week 2, and low dose during week 3.
439273|NCT00576472|O2|Outcome|Low Dose|Patients assigned to the Low Dose group were randomly assigned to receive one of two arms: Group LMP received low dose during week one, moderate dose during week 2, and placebo during week 3; Group LPM received low dose during week one, placebo during week 2, and moderate dose during week 3.
439274|NCT00576472|O1|Outcome|Placebo|Patients assigned to the placebo group were randomly assigned to receive one of two arms: Group PLM received placebo during week one, low dose during week 2, and moderate dose during week 3; Group PML received placebo during week one, moderate dose during week 2, and low dose during week 3.
439275|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Math: Composite Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
439276|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Spelling: Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
439277|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Reading: Composite Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
439278|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Social Skills Rating System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
439279|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: Cognitive Problem T Questionnaire and 68 were screen at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
439280|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: ADHD T Questionnaire and 68 were screen at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
439281|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: Cognitive Problem T Score Questionnaire and 59 were screen at completion. 47 patients were screened at both the beginning and end of the home maintenance phase.
439284|NCT00576472|O3|Outcome|Moderate Treatment Intensity|Moderately intense central nervous system therapy (<= 24 Gy CRT with or without systemic and/or intrathecal chemotherapy).
439295|NCT00576524|B2|Baseline|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
439296|NCT00576524|B1|Baseline|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
439297|NCT00576524|P2|Participant Flow|Sham Device First, ITD Next|A group of subjects will be randomized to receive sham first, followed by ITD 7 days later.
439298|NCT00576524|P1|Participant Flow|ITD First, Sham Device Next|A group of subjects will be randomized to receive the ITD first, followed by sham 7 days later.
439299|NCT00576524|O2|Outcome|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
439300|NCT00576524|O1|Outcome|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
439301|NCT00576524|O2|Outcome|ITD First, Sham Device Next|A group of subjects will be randomized to receive ITD, followed by sham device 7 days later.
439302|NCT00576524|O1|Outcome|Sham Device First, ITD Next|A group of subjects will be randomized to receive the sham device, follwed by ITD 7 days later.
439303|NCT00576524|O2|Outcome|ITD First, Sham Device Next|A group of subjects will be randomized to receive ITD, followed by sham device after 7 days.
439304|NCT00576524|O1|Outcome|Sham Device First, ITD Next|A group of subjects will be randomized to receive the sham device, followed by ITD next after 7 days.
439305|NCT00576524|E2|Reported Event|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
439306|NCT00576524|E1|Reported Event|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
439307|NCT00576576|B1|Baseline|Atorvastatin|"All patients in this arm are given atorvastatin therapy.
Atorvastatin : Atorvastatin 80 mg a day"
439308|NCT00576576|P1|Participant Flow|Atorvastatin|"All patients in this arm are given atorvastatin therapy.
Atorvastatin : Atorvastatin 80 mg a day"
439309|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.
Atorvastatin : Atorvastatin 80 mg a day"
439310|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.
Atorvastatin : Atorvastatin 80 mg a day"
439311|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.
Atorvastatin : Atorvastatin 80 mg a day"
439312|NCT00576576|E1|Reported Event|Atorvastatin|"All patients in this arm are given atorvastatin therapy.
Atorvastatin : Atorvastatin 80 mg a day"
439313|NCT00576628|B1|Baseline|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439314|NCT00576628|P1|Participant Flow|C.E.R.A|Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator [C.E.R.A]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.
439315|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439316|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439317|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439318|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439319|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439320|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439321|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439322|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439323|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439324|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439325|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439326|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439327|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range..
439328|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439329|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439330|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439331|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439332|NCT00576628|E1|Reported Event|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
439333|NCT00576693|B3|Baseline|Total|Total of all reporting groups
439334|NCT00576693|B2|Baseline|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)
intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
439335|NCT00576693|B1|Baseline|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).
intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
439336|NCT00576693|P2|Participant Flow|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)
intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
439337|NCT00576693|P1|Participant Flow|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).
intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
439338|NCT00576693|O2|Outcome|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)
intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
439357|NCT00576732|O1|Outcome|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
439358|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
439701|NCT00577395|O2|Outcome|Placebo Tablet Once a Month|Placebo tablet once a month, orally
439339|NCT00576693|O1|Outcome|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).
intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
439340|NCT00576693|E2|Reported Event|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)
intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
439341|NCT00576693|E1|Reported Event|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).
intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
439342|NCT00576732|B4|Baseline|Total|Total of all reporting groups
439343|NCT00576732|B3|Baseline|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
439344|NCT00576732|B2|Baseline|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
439345|NCT00576732|B1|Baseline|Placebo|Double-blind Period. Oral solution for 6 weeks.
439346|NCT00576732|P6|Participant Flow|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
439347|NCT00576732|P5|Participant Flow|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
439348|NCT00576732|P4|Participant Flow|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
439349|NCT00576732|P3|Participant Flow|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
439350|NCT00576732|P2|Participant Flow|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
439351|NCT00576732|P1|Participant Flow|Placebo|Double-blind Period. Oral solution for 6 weeks.
439352|NCT00576732|O3|Outcome|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
439353|NCT00576732|O2|Outcome|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
439354|NCT00576732|O1|Outcome|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
439355|NCT00576732|O3|Outcome|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
439356|NCT00576732|O2|Outcome|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
439359|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
439360|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
441392|NCT00588731|P1|Participant Flow|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
439361|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
439362|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
439363|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
439364|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
439365|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
439366|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
439367|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
439368|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
439369|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
439370|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
439371|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
439372|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
439373|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
439374|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
439375|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
439376|NCT00576732|E4|Reported Event|Open-label Risperidone|Subjects who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
439377|NCT00576732|E3|Reported Event|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
439378|NCT00576732|E2|Reported Event|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
439379|NCT00576732|E1|Reported Event|Placebo|Double-blind Period. Oral solution for 6 weeks.
439380|NCT00576758|B3|Baseline|Total|Total of all reporting groups
439381|NCT00576758|B2|Baseline|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439382|NCT00576758|B1|Baseline|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439383|NCT00576758|P2|Participant Flow|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439384|NCT00576758|P1|Participant Flow|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439385|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439386|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439387|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439388|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439444|NCT00576823|E1|Reported Event|Afluzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
439389|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439390|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439391|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439392|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439393|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439394|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439395|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439396|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439397|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439398|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439399|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439400|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439401|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439402|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439442|NCT00576823|E3|Reported Event|Afluzosin Tablets - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
439501|NCT00577083|B3|Baseline|Total|Total of all reporting groups
439403|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439404|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439405|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439406|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439407|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439408|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439409|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439410|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439411|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439412|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439413|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439414|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439415|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439416|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439443|NCT00576823|E2|Reported Event|Afluzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
439575|NCT00577135|O2|Outcome|Continuous Infusion|
439417|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439418|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439419|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439420|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439421|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439422|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439423|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439424|NCT00576758|E2|Reported Event|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439425|NCT00576758|E1|Reported Event|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
439426|NCT00576823|B4|Baseline|Total|Total of all reporting groups
439427|NCT00576823|B3|Baseline|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
439428|NCT00576823|B2|Baseline|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
439429|NCT00576823|B1|Baseline|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
439430|NCT00576823|P3|Participant Flow|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
439431|NCT00576823|P2|Participant Flow|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
439432|NCT00576823|P1|Participant Flow|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
439433|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|
439434|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|
439435|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|
439436|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|
439437|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|
439438|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|
439439|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
439440|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
439441|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
439445|NCT00576901|B1|Baseline|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
439446|NCT00576901|P1|Participant Flow|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1; docetaxel 75 mg per square meter (mg/m^2), IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
439447|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
439448|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
439449|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
439450|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
439451|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
439452|NCT00576901|E1|Reported Event|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
439453|NCT00576927|B3|Baseline|Total|Total of all reporting groups
439454|NCT00576927|B2|Baseline|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
439455|NCT00576927|B1|Baseline|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
439456|NCT00576927|P1|Participant Flow|All Subjects|
439457|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
439458|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
439459|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
439460|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
439461|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
439462|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
439463|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
439464|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
439465|NCT00576927|E2|Reported Event|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
439466|NCT00576927|E1|Reported Event|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
439467|NCT00577005|B3|Baseline|Total|Total of all reporting groups
439468|NCT00577005|B2|Baseline|Placebo|"matching placebo
Placebo"
439469|NCT00577005|B1|Baseline|Levetiracetam|"Levetiracetam tablets
levetiracetam: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period."
439470|NCT00577005|P2|Participant Flow|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.
Placebo: Placebo orally everyday for 13 weeks"
439471|NCT00577005|P1|Participant Flow|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.
Levetiracetam: 3000mg orally everyday for 12 weeks"
439472|NCT00577005|O2|Outcome|Placebo|"matching placebo
Placebo"
439473|NCT00577005|O1|Outcome|Levetiracetam|"Levetiracetam tablets
levetiracetam: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period."
439474|NCT00577005|O2|Outcome|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.
Placebo: Placebo orally everyday for 13 weeks"
439475|NCT00577005|O1|Outcome|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.
Levetiracetam: 3000mg orally everyday for 12 weeks"
439476|NCT00577005|O2|Outcome|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.
Placebo: Placebo orally everyday for 13 weeks"
439477|NCT00577005|O1|Outcome|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.
Levetiracetam: 3000mg orally everyday for 12 weeks"
439478|NCT00577005|O2|Outcome|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.
Placebo: Placebo orally everyday for 13 weeks"
439479|NCT00577005|O1|Outcome|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.
Levetiracetam: 3000mg orally everyday for 12 weeks"
439480|NCT00577005|E2|Reported Event|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.
Placebo: Placebo orally everyday for 13 weeks"
439481|NCT00577005|E1|Reported Event|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.
Levetiracetam: 3000mg orally everyday for 12 weeks"
439482|NCT00577031|B1|Baseline|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439483|NCT00577031|P1|Participant Flow|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439484|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439485|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439486|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439487|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439576|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439577|NCT00577135|O4|Outcome|High Intensification|
439578|NCT00577135|O3|Outcome|Low Intensification|
439579|NCT00577135|O2|Outcome|Continuous Infusion|
439488|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439489|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439490|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439491|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439492|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439493|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles):If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439494|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles):If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439495|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439496|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles):
Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day
1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles):
If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439497|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439498|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439499|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439500|NCT00577031|E1|Reported Event|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
439502|NCT00577083|B2|Baseline|Initial Cap-fitted First Then No Cap|"Initial cap-fitted colonoscopy for the first insertion
Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
439503|NCT00577083|B1|Baseline|No Cap First, Then Cap Fitted|"no cap on the end of the colonoscope for the first insertion
Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
439504|NCT00577083|P2|Participant Flow|Initial Cap-fitted First, Then No Cap|"Initial cap-fitted colonoscopy for the first insertion
Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
439505|NCT00577083|P1|Participant Flow|No Cap First, Then Cap-fitted|"no cap on the end of the colonoscope for the first insertion
Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
439506|NCT00577083|O2|Outcome|Initial Regular|"no cap on the end of the colonoscope for the first insertion
Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
439507|NCT00577083|O1|Outcome|Initial Cap-fitted|"Initial cap-fitted colonoscopy for the first insertion
Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
439508|NCT00577083|E2|Reported Event|Initial Cap-fitted|"Initial cap-fitted colonoscopy for the first insertion
Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
439509|NCT00577083|E1|Reported Event|Initial Regular|"no cap on the end of the colonoscope for the first insertion
Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
439510|NCT00577096|B3|Baseline|Total|Total of all reporting groups
439511|NCT00577096|B2|Baseline|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439512|NCT00577096|B1|Baseline|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439513|NCT00577096|P2|Participant Flow|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439580|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439581|NCT00577135|O4|Outcome|High Intensification|
439582|NCT00577135|O3|Outcome|Low Intensification|
439583|NCT00577135|O2|Outcome|Continuous Infusion|
439584|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439585|NCT00577135|O4|Outcome|High Intensification|
439586|NCT00577135|O3|Outcome|Low Intensification|
439587|NCT00577135|O2|Outcome|Continuous Infusion|
439588|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439514|NCT00577096|P1|Participant Flow|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439515|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439516|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439517|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439518|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439519|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439520|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439589|NCT00577135|O4|Outcome|High Intensification|
439590|NCT00577135|O3|Outcome|Low Intensification|
439591|NCT00577135|O2|Outcome|Continuous Infusion|
439592|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439593|NCT00577135|O4|Outcome|High Intensification|
439594|NCT00577135|O3|Outcome|Low Intensification|
439595|NCT00577135|O2|Outcome|Continuous Infusion|
439596|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439597|NCT00577135|O4|Outcome|High Intensification|
439521|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439522|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439523|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439524|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439525|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439526|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439527|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439598|NCT00577135|O3|Outcome|Low Intensification|
439599|NCT00577135|O2|Outcome|Continuous Infusion|
439600|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439601|NCT00577135|O4|Outcome|High Intensification|
439602|NCT00577135|O3|Outcome|Low Intensification|
439603|NCT00577135|O2|Outcome|Continuous Infusion|
439604|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439605|NCT00577135|O4|Outcome|High Intensification|
439606|NCT00577135|O3|Outcome|Low Intensification|
439528|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439529|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439530|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439531|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439532|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439533|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439534|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439607|NCT00577135|O2|Outcome|Continuous Infusion|
439608|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439609|NCT00577135|O4|Outcome|High Intensification|
439610|NCT00577135|O3|Outcome|Low Intensification|
439611|NCT00577135|O2|Outcome|Continuous Infusion|
439612|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439613|NCT00577135|O4|Outcome|High Intensification|
439614|NCT00577135|O3|Outcome|Low Intensification|
439615|NCT00577135|O2|Outcome|Continuous Infusion|
439535|NCT00577096|E2|Reported Event|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
439536|NCT00577096|E1|Reported Event|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
439537|NCT00577122|B3|Baseline|Total|Total of all reporting groups
439538|NCT00577122|B2|Baseline|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
439539|NCT00577122|B1|Baseline|Cohort 1: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
439540|NCT00577122|P2|Participant Flow|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
439541|NCT00577122|P1|Participant Flow|Cohort 1: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
439542|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
439543|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
439544|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
439545|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
439546|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
439547|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
439548|NCT00577122|O2|Outcome|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
439549|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
439550|NCT00577122|E2|Reported Event|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
439551|NCT00577122|E1|Reported Event|Cohort 1: MPA Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
439552|NCT00577135|B5|Baseline|Total|Total of all reporting groups
439553|NCT00577135|B4|Baseline|Continuous Infusion & High Intensification|
439554|NCT00577135|B3|Baseline|Continuous Infusion & Low Intensification|
439555|NCT00577135|B2|Baseline|Q12 Hours Bolus & High Intensification|
439556|NCT00577135|B1|Baseline|Q12 Hours Bolus & Low Intensification|
439557|NCT00577135|P4|Participant Flow|Continuous Infusion & High Intensification|High intensification (2.5 x oral dose) IV furosemide by continuous infusion
439558|NCT00577135|P3|Participant Flow|Continuous Infusion & Low Intensification|Low intensification (1 x oral dose) IV furosemide by continuous infusion
439559|NCT00577135|P2|Participant Flow|Q12 Hours Bolus & High Intensification|High intensification (2.5 x oral dose) IV furosemide by Q12 hours bolus
439560|NCT00577135|P1|Participant Flow|Q12 Hours Bolus & Low Intensification|Low intensification (1 x oral dose) IV furosemide by Q12 hours bolus
439561|NCT00577135|O4|Outcome|High Intensification|
439562|NCT00577135|O3|Outcome|Low Intensification|
439563|NCT00577135|O2|Outcome|Continuous Infusion|
439564|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439565|NCT00577135|O4|Outcome|High Intensification|
439566|NCT00577135|O3|Outcome|Low Intensification|
439567|NCT00577135|O2|Outcome|Continuous Infusion|
439568|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439569|NCT00577135|O4|Outcome|High Intensification|
439570|NCT00577135|O3|Outcome|Low Intensification|
439571|NCT00577135|O2|Outcome|Continuous Infusion|
439572|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
439573|NCT00577135|O4|Outcome|High Intensification|
439574|NCT00577135|O3|Outcome|Low Intensification|
439677|NCT00577356|B1|Baseline|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
439678|NCT00577356|P1|Participant Flow|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
439679|NCT00577356|O1|Outcome|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
439680|NCT00577356|E1|Reported Event|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
439681|NCT00577382|B3|Baseline|Total|Total of all reporting groups
439682|NCT00577382|B2|Baseline|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
439683|NCT00577382|B1|Baseline|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
439684|NCT00577382|P2|Participant Flow|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
439685|NCT00577382|P1|Participant Flow|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
439686|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
439687|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
439688|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
439689|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
439690|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
439691|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
439692|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
439693|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
439694|NCT00577382|E2|Reported Event|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
439695|NCT00577382|E1|Reported Event|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
439696|NCT00577395|B3|Baseline|Total|Total of all reporting groups
439697|NCT00577395|B2|Baseline|Placebo Tablet Once a Month|Placebo tablet once a month, orally
439698|NCT00577395|B1|Baseline|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
439699|NCT00577395|P2|Participant Flow|Placebo Tablet Once a Month|Placebo tablet once a month, orally
439700|NCT00577395|P1|Participant Flow|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
441393|NCT00588731|O2|Outcome|Placebo|Placebo: Placebo
439702|NCT00577395|O1|Outcome|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
439703|NCT00577395|O2|Outcome|Placebo Tablet Once a Month|Placebo tablet once a month, orally
439704|NCT00577395|O1|Outcome|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
439705|NCT00577395|E2|Reported Event|Placebo Tablet Once a Month|Placebo tablet once a month, orally
439706|NCT00577395|E1|Reported Event|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
439707|NCT00577408|B3|Baseline|Total|Total of all reporting groups
439708|NCT00577408|B2|Baseline|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).
Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
439709|NCT00577408|B1|Baseline|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
439710|NCT00577408|P2|Participant Flow|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).
Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
439711|NCT00577408|P1|Participant Flow|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
439712|NCT00577408|O2|Outcome|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).
Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
439713|NCT00577408|O1|Outcome|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
439714|NCT00577408|E2|Reported Event|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).
Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
439715|NCT00577408|E1|Reported Event|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
439716|NCT00577460|B4|Baseline|Total|Total of all reporting groups
439717|NCT00577460|B3|Baseline|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439718|NCT00577460|B2|Baseline|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439719|NCT00577460|B1|Baseline|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439720|NCT00577460|P3|Participant Flow|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole Immediate Release (IR) in previous trial
439721|NCT00577460|P2|Participant Flow|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439722|NCT00577460|P1|Participant Flow|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439723|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439724|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439725|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439726|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439727|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439728|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439729|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439730|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439731|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439732|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439733|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439734|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439735|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439736|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439737|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439738|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439739|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439740|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439741|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439742|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439743|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439744|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439745|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439746|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439747|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439748|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439749|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439750|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439751|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439752|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439753|NCT00577460|O3|Outcome|PPX IR|Treatment with Pramipexole IR in previous trial
439754|NCT00577460|O2|Outcome|PPX ER|Treatment with Pramipexole ER in previous trial
439755|NCT00577460|O1|Outcome|Placebo|Treatment with matching placebo in previous trial (NCT00466167)
439756|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
439757|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439758|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439759|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439760|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
439761|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439762|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439763|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439764|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
439765|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439766|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439767|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439768|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439769|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439770|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439771|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439772|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439773|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439774|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439775|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439776|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439777|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439778|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439779|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439780|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439781|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439782|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439783|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
439784|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439785|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439786|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439787|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
439788|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439789|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439790|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439791|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
439792|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439793|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439794|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439795|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439796|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439797|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439798|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439799|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439800|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439801|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439802|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439803|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439804|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439805|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439806|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439807|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
439808|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439809|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439810|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439811|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439812|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439813|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439814|NCT00577460|O2|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439815|NCT00577460|O1|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439816|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439817|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439818|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439819|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439820|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439821|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439822|NCT00577460|O2|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439823|NCT00577460|O1|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439824|NCT00577460|E4|Reported Event|Total PPX ER|Pramipexole ER, all patients
439825|NCT00577460|E3|Reported Event|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
439826|NCT00577460|E2|Reported Event|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
439827|NCT00577460|E1|Reported Event|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
439828|NCT00577473|B3|Baseline|Total|Total of all reporting groups
439829|NCT00577473|B2|Baseline|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439830|NCT00577473|B1|Baseline|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439831|NCT00577473|P2|Participant Flow|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439832|NCT00577473|P1|Participant Flow|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439833|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439834|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439835|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439836|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439837|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439838|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439839|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439840|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439841|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439842|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439843|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439844|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439845|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439846|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439847|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439848|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439849|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439850|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439851|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439852|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439853|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439854|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439855|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439856|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439857|NCT00577473|E2|Reported Event|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
439858|NCT00577473|E1|Reported Event|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
439859|NCT00577512|B1|Baseline|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored
High dose DTPACE and stem cell re-infusion
VTD Maintenance therapy"
439860|NCT00577512|P1|Participant Flow|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored
High dose DTPACE and stem cell re-infusion
VTD Maintenance therapy"
439861|NCT00577512|O1|Outcome|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored
High dose DTPACE and stem cell re-infusion
VTD Maintenance therapy"
439862|NCT00577512|E1|Reported Event|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored
High dose DTPACE and stem cell re-infusion
VTD Maintenance therapy"
439863|NCT00577629|B1|Baseline|All Subjects|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
439864|NCT00577629|P1|Participant Flow|All Subjects|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
439865|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
439866|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar)
439867|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
439868|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
439869|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
439870|NCT00577629|E1|Reported Event|Experimental: Induction + Consolidation + Bexxar|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
439871|NCT00577642|B1|Baseline|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period
439872|NCT00577642|P1|Participant Flow|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period.
439873|NCT00577642|O1|Outcome|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) treatment cessation during study period.
439874|NCT00577642|E1|Reported Event|Single Arm Study|This was a nonintervention biomarker study after a single dose of Zoledronic acid.
439875|NCT00577655|B3|Baseline|Total|Total of all reporting groups
439876|NCT00577655|B2|Baseline|Placebo|Placebo HFA-MDI four times a day for 21 days.
441394|NCT00588731|O1|Outcome|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
439877|NCT00577655|B1|Baseline|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439878|NCT00577655|P2|Participant Flow|Placebo|Placebo HFA-MDI four times a day for 21 days.
439879|NCT00577655|P1|Participant Flow|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439880|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439881|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439882|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439883|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439884|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439885|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439886|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439887|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439888|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439889|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439890|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439891|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439892|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439893|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439894|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439895|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439896|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439897|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439898|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439899|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439900|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
439901|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439902|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439903|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439904|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
439905|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439906|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
439907|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439908|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
439909|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439910|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
439911|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439912|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
439913|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
439914|NCT00577655|E2|Reported Event|Placebo|Placebo HFA-MDI four times a day for 21 days.
439915|NCT00577655|E1|Reported Event|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day
439916|NCT00577707|B1|Baseline|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
439917|NCT00577707|P1|Participant Flow|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
439918|NCT00577707|O1|Outcome|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
439919|NCT00577707|E1|Reported Event|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
439920|NCT00577720|B5|Baseline|Total|Total of all reporting groups
439921|NCT00577720|B4|Baseline|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
439922|NCT00577720|B3|Baseline|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439923|NCT00577720|B2|Baseline|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439924|NCT00577720|B1|Baseline|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
439925|NCT00577720|P4|Participant Flow|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
439926|NCT00577720|P3|Participant Flow|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439927|NCT00577720|P2|Participant Flow|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439928|NCT00577720|P1|Participant Flow|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
441395|NCT00588731|O2|Outcome|Placebo|Placebo: Placebo
439929|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
439930|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439931|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439932|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
439933|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
439934|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439935|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439936|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
439937|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
439938|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439939|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439940|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
439941|NCT00577720|E4|Reported Event|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
439942|NCT00577720|E3|Reported Event|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439943|NCT00577720|E2|Reported Event|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
439944|NCT00577720|E1|Reported Event|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
439945|NCT00577772|B3|Baseline|Total|Total of all reporting groups
439946|NCT00577772|B2|Baseline|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).
The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
439947|NCT00577772|B1|Baseline|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
439948|NCT00577772|P2|Participant Flow|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).
The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
439949|NCT00577772|P1|Participant Flow|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
439950|NCT00577772|O2|Outcome|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).
The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
439951|NCT00577772|O1|Outcome|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
440016|NCT00577863|B2|Baseline|Not Current Users|A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
440210|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440211|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
439952|NCT00577772|E2|Reported Event|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).
The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
439953|NCT00577772|E1|Reported Event|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
439954|NCT00577824|B4|Baseline|Total|Total of all reporting groups
439955|NCT00577824|B3|Baseline|Placebo BID|placebo SC, twice daily
439956|NCT00577824|B2|Baseline|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439957|NCT00577824|B1|Baseline|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439958|NCT00577824|P3|Participant Flow|Placebo BID|placebo SC, twice daily
439959|NCT00577824|P2|Participant Flow|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439960|NCT00577824|P1|Participant Flow|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439961|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439962|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439963|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439964|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439965|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439966|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439967|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439968|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439969|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439970|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439971|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439972|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439973|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439974|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439975|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439976|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439977|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439978|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439979|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439980|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439981|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439982|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439983|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439984|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439985|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439986|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439987|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439988|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439989|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439990|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439991|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439992|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439993|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439994|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439995|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439996|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
439997|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
439998|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
439999|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
440000|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
440001|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
440002|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
440003|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
440004|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
440005|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
440006|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
440007|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
440008|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
440009|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
440010|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
440011|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
440012|NCT00577824|E3|Reported Event|Placebo BID|placebo SC, twice daily
440013|NCT00577824|E2|Reported Event|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
440014|NCT00577824|E1|Reported Event|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
440015|NCT00577863|B3|Baseline|Total|Total of all reporting groups
440017|NCT00577863|B1|Baseline|Current Users|A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
440018|NCT00577863|P2|Participant Flow|Not Current Users|A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
440019|NCT00577863|P1|Participant Flow|Current Users|A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
440020|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
440021|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
440022|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440023|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440024|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440025|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440026|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440027|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440028|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440029|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440030|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440031|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440032|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440033|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440034|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440035|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440036|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440037|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440038|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440039|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440040|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440041|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440042|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440043|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440044|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
440045|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
440046|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
440047|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
440048|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
440049|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
440050|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
440051|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
440052|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
440053|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
440054|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
440055|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
440056|NCT00577863|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms per day
440057|NCT00577889|B4|Baseline|Total|Total of all reporting groups
440058|NCT00577889|B3|Baseline|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440059|NCT00577889|B2|Baseline|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440207|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440208|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440060|NCT00577889|B1|Baseline|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440061|NCT00577889|P3|Participant Flow|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440062|NCT00577889|P2|Participant Flow|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440063|NCT00577889|P1|Participant Flow|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440064|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440065|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440066|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440067|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440068|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440069|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440070|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440071|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440072|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440073|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440074|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440075|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440076|NCT00577889|E3|Reported Event|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440077|NCT00577889|E2|Reported Event|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
442762|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
440078|NCT00577889|E1|Reported Event|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
440079|NCT00578071|B1|Baseline|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
440080|NCT00578071|P1|Participant Flow|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
440081|NCT00578071|O1|Outcome|Arm 1 Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
440082|NCT00578071|O1|Outcome|Arm 1 Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
440083|NCT00578071|O1|Outcome|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
440084|NCT00578071|O1|Outcome|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
440085|NCT00578071|E1|Reported Event|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
440086|NCT00578136|B3|Baseline|Total|Total of all reporting groups
440087|NCT00578136|B2|Baseline|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
440088|NCT00578136|B1|Baseline|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
440089|NCT00578136|P2|Participant Flow|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
440090|NCT00578136|P1|Participant Flow|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
440091|NCT00578136|O2|Outcome|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
440092|NCT00578136|O1|Outcome|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
440093|NCT00578136|O2|Outcome|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
440094|NCT00578136|O1|Outcome|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
440095|NCT00578136|E2|Reported Event|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
440096|NCT00578136|E1|Reported Event|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
440097|NCT00578175|B4|Baseline|Total|Total of all reporting groups
440098|NCT00578175|B3|Baseline|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440099|NCT00578175|B2|Baseline|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440100|NCT00578175|B1|Baseline|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440101|NCT00578175|P3|Participant Flow|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440102|NCT00578175|P2|Participant Flow|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440103|NCT00578175|P1|Participant Flow|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440104|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440105|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440106|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440107|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440108|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440209|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440212|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440109|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440110|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440111|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440112|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440113|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440114|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440115|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440116|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440117|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440118|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440119|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440120|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440121|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440122|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440123|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440124|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440125|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440126|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440127|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440128|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
441396|NCT00588731|O1|Outcome|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
440129|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440130|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440131|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440132|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440133|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440134|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440135|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440136|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440137|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440138|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440139|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440140|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440141|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440142|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440143|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440144|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440145|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440146|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440147|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440148|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440149|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440150|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440151|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440152|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440153|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440154|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440155|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440156|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440157|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440158|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440159|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440160|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440161|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440162|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440163|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440164|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440165|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440166|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440167|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440168|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440263|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440169|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440170|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440171|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440172|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440173|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440174|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440175|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440176|NCT00578175|E3|Reported Event|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
440177|NCT00578175|E2|Reported Event|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440178|NCT00578175|E1|Reported Event|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
440179|NCT00578214|B4|Baseline|Total|Total of all reporting groups
440180|NCT00578214|B3|Baseline|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440181|NCT00578214|B2|Baseline|Placebo|Randomized patients receiving placebo syrup
440182|NCT00578214|B1|Baseline|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440183|NCT00578214|P3|Participant Flow|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440184|NCT00578214|P2|Participant Flow|Placebo|Randomized patients receiving placebo syrup
440185|NCT00578214|P1|Participant Flow|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440186|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440187|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440188|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440189|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440190|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440191|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440192|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440193|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440194|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440195|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440196|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440197|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440198|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440199|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440200|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440201|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440202|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440203|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440204|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440205|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440206|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440213|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440214|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440215|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440216|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440217|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440218|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440219|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440220|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440221|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440222|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440223|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440224|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440225|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440226|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
440227|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440228|NCT00578214|E3|Reported Event|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
440229|NCT00578214|E2|Reported Event|Placebo|Randomized patients receiving placebo syrup
440230|NCT00578214|E1|Reported Event|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
440231|NCT00578227|B4|Baseline|Total|Total of all reporting groups
440232|NCT00578227|B3|Baseline|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440233|NCT00578227|B2|Baseline|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440234|NCT00578227|B1|Baseline|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440235|NCT00578227|P3|Participant Flow|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440236|NCT00578227|P2|Participant Flow|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440237|NCT00578227|P1|Participant Flow|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440238|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440239|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440240|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440241|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440242|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440243|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440244|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440245|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440246|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440247|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440248|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440249|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440250|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440251|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440252|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440253|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440254|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440255|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440256|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440257|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440258|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440259|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440260|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440261|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440262|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440264|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440265|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440266|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440267|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440268|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440269|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440270|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440271|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440272|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440273|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440274|NCT00578227|O4|Outcome|9-Year Old Cervarix Vaccine Recipients|All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
440275|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440276|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440277|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440278|NCT00578227|O4|Outcome|9-Year Old Cervarix Vaccine Recipients|All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
440279|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440280|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440281|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440282|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440283|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440284|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440285|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440286|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440287|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440288|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440289|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440290|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440291|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440292|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440293|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440294|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440295|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440296|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440297|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440298|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440299|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440300|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440301|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440302|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440303|NCT00578227|E3|Reported Event|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
440304|NCT00578227|E2|Reported Event|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
440305|NCT00578227|E1|Reported Event|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
440306|NCT00578279|B3|Baseline|Total|Total of all reporting groups
440307|NCT00578279|B2|Baseline|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
440308|NCT00578279|B1|Baseline|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
440309|NCT00578279|P2|Participant Flow|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
441397|NCT00588731|E2|Reported Event|Placebo|Placebo: Placebo
440310|NCT00578279|P1|Participant Flow|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
440311|NCT00578279|O2|Outcome|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
440312|NCT00578279|O1|Outcome|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
440313|NCT00578279|E2|Reported Event|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
440314|NCT00578279|E1|Reported Event|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
440315|NCT00578305|B4|Baseline|Total|Total of all reporting groups
440316|NCT00578305|B3|Baseline|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440317|NCT00578305|B2|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440318|NCT00578305|B1|Baseline|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440319|NCT00578305|P3|Participant Flow|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440320|NCT00578305|P2|Participant Flow|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440321|NCT00578305|P1|Participant Flow|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440322|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440323|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440324|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440406|NCT00578383|P2|Participant Flow|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
441398|NCT00588731|E1|Reported Event|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
440325|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440326|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440327|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440328|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440329|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440330|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440331|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440332|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440333|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440334|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440407|NCT00578383|P1|Participant Flow|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440408|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
440335|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440336|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440337|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440338|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440339|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440340|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440341|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440342|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440343|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440344|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440409|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440410|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440345|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440346|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440347|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440348|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440349|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440350|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440351|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440352|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440353|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440354|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440411|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440412|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
440355|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440356|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440357|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440358|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440359|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440360|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440361|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440362|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440363|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440364|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440413|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440414|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440365|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440366|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440367|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440368|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440369|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440370|NCT00578305|E9|Reported Event|Placebo - Safety Follow-up Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440371|NCT00578305|E8|Reported Event|Rituximab 1000 mg - Safety Follow-up Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440372|NCT00578305|E7|Reported Event|Rituximab 500 mg - Safety Follow-up Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440373|NCT00578305|E6|Reported Event|Placebo - Extension Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440374|NCT00578305|E5|Reported Event|Rituximab 1000 mg - Extension Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440415|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440754|NCT00584987|B3|Baseline|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440375|NCT00578305|E4|Reported Event|Rituximab 500 mg - Extension Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440376|NCT00578305|E3|Reported Event|Placebo - Double-blind Treatment Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440377|NCT00578305|E2|Reported Event|Rituximab 1000 mg - Double-blind Treatment Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440378|NCT00578305|E1|Reported Event|Rituximab 500 mg - Double-blind Treatment Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
440379|NCT00578318|B3|Baseline|Total|Total of all reporting groups
440380|NCT00578318|B2|Baseline|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
440381|NCT00578318|B1|Baseline|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
440382|NCT00578318|P2|Participant Flow|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
440383|NCT00578318|P1|Participant Flow|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
440384|NCT00578318|O2|Outcome|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
440385|NCT00578318|O1|Outcome|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
440386|NCT00578318|E2|Reported Event|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
440387|NCT00578318|E1|Reported Event|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
440388|NCT00578331|B3|Baseline|Total|Total of all reporting groups
440389|NCT00578331|B2|Baseline|Olopatadine 0.6% Nasal Spray|
440390|NCT00578331|B1|Baseline|Placebo Nasal Spray|
440391|NCT00578331|P2|Participant Flow|Olopatadine 0.6% Nasal Spray|2 sprays each nostril twice daily
440392|NCT00578331|P1|Participant Flow|Placebo Nasal Spray|2 sprays each nostril twice daily
440393|NCT00578331|O2|Outcome|Olopatadine 0.6% Nasal Spray|
440394|NCT00578331|O1|Outcome|Placebo Nasal Spray|
440395|NCT00578331|O2|Outcome|Olopatadine 0.6% Nasal Spray|
440396|NCT00578331|O1|Outcome|Placebo Nasal Spray|
440397|NCT00578331|E2|Reported Event|Olopatadine 0.6% Nasal Spray|
440398|NCT00578331|E1|Reported Event|Placebo Nasal Spray|
440399|NCT00578383|B5|Baseline|Total|Total of all reporting groups
440400|NCT00578383|B4|Baseline|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440401|NCT00578383|B3|Baseline|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440402|NCT00578383|B2|Baseline|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440403|NCT00578383|B1|Baseline|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440404|NCT00578383|P4|Participant Flow|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440405|NCT00578383|P3|Participant Flow|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440869|NCT00586898|E1|Reported Event|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
440416|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
440417|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440418|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440419|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440420|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
440421|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440422|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440423|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440424|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440425|NCT00578383|O1|Outcome|Combined Groups Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
440426|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440427|NCT00578383|O1|Outcome|Combined Groups Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
440428|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440429|NCT00578383|O1|Outcome|Combined Group Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
440430|NCT00578383|O2|Outcome|Combined Group Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440431|NCT00578383|O1|Outcome|Combined Group Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
440432|NCT00578383|E4|Reported Event|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440433|NCT00578383|E3|Reported Event|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440434|NCT00578383|E2|Reported Event|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
440435|NCT00578383|E1|Reported Event|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
440436|NCT00578448|B1|Baseline|IV Belatacept 10mg/kg With 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial.
440437|NCT00578448|P1|Participant Flow|Belatacept 10mg/kg; 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial (3 years and then a 1 year extension was available for those who completed the 3rd year).
440438|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
440439|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
440440|NCT00578448|O1|Outcome|Belatacept 10mg/kg; 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study (3 years planned study; 1 year extension allowed to those who completed 3rd year).
440515|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440441|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
440442|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
440443|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
440444|NCT00578448|O1|Outcome|10mg/kg IV Belatacept|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
440445|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
440446|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
440447|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
440448|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
440449|NCT00578448|E1|Reported Event|Bela 10-5mg/kg|
440450|NCT00578461|B1|Baseline|Stem Cell Transplant|All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
440451|NCT00578461|P1|Participant Flow|Stem Cell Transplant|"All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide.
Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0."
440452|NCT00578461|O1|Outcome|Stem Cell Transplant|All patients will be receiving a stem cell transplant on study. Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation.
440453|NCT00578461|E1|Reported Event|Stem Cell Transplant|"All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0."
440454|NCT00578539|B1|Baseline|Stem Cell Transplant|All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
440455|NCT00578539|P1|Participant Flow|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
440456|NCT00578539|O1|Outcome|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
440457|NCT00578539|E1|Reported Event|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
440458|NCT00578552|B4|Baseline|Total|Total of all reporting groups
440755|NCT00584987|B2|Baseline|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440459|NCT00578552|B3|Baseline|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440460|NCT00578552|B2|Baseline|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440461|NCT00578552|B1|Baseline|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440462|NCT00578552|P3|Participant Flow|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440463|NCT00578552|P2|Participant Flow|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440464|NCT00578552|P1|Participant Flow|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440465|NCT00578552|O3|Outcome|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440466|NCT00578552|O2|Outcome|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440467|NCT00578552|O1|Outcome|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440468|NCT00578552|E3|Reported Event|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440469|NCT00578552|E2|Reported Event|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440470|NCT00578552|E1|Reported Event|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
440471|NCT00578565|B1|Baseline|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
440472|NCT00578565|P1|Participant Flow|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
440473|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V. on each days 1 and 15 with repeat dosing at 6 months
440474|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
440475|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
440476|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
440477|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V. on each days 1 and 15 with repeat dosing at 6 months
440478|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
440479|NCT00578565|E1|Reported Event|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
440480|NCT00578617|B3|Baseline|Total|Total of all reporting groups
440481|NCT00578617|B2|Baseline|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
440482|NCT00578617|B1|Baseline|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
440483|NCT00578617|P2|Participant Flow|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
440618|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440484|NCT00578617|P1|Participant Flow|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
440485|NCT00578617|O2|Outcome|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
440486|NCT00578617|O1|Outcome|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
440487|NCT00578617|E2|Reported Event|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
440488|NCT00578617|E1|Reported Event|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
440489|NCT00578734|B3|Baseline|Total|Total of all reporting groups
440490|NCT00578734|B2|Baseline|Sham Air|Sham air (placebo) instillation
440491|NCT00578734|B1|Baseline|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
440492|NCT00578734|P2|Participant Flow|Sham Air|Sham air (placebo) instillation
440493|NCT00578734|P1|Participant Flow|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
440494|NCT00578734|O2|Outcome|Sham Air|Sham air (placebo) instillation
440495|NCT00578734|O1|Outcome|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
440496|NCT00578734|O2|Outcome|Sham Air|Sham air (placebo) instillation
440497|NCT00578734|O1|Outcome|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
440498|NCT00578734|E2|Reported Event|Sham Air|Sham air (placebo) instillation
440499|NCT00578734|E1|Reported Event|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
440500|NCT00578786|B4|Baseline|Total|Total of all reporting groups
440501|NCT00578786|B3|Baseline|Ambrisentan 10 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies).
440502|NCT00578786|B2|Baseline|Ambrisentan 5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, a third starting at 5 mg were titrated to 10 mg.
440503|NCT00578786|B1|Baseline|Ambrisentan 2.5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, almost half of those randomized to AMB 2.5 mg were titrated to 5 mg and 10 mg.
440504|NCT00578786|P3|Participant Flow|Ambrisentan 10 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies).
440505|NCT00578786|P2|Participant Flow|Ambrisentan 5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, a third starting at 5 mg were titrated to 10 mg.
440506|NCT00578786|P1|Participant Flow|Ambrisentan 2.5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, almost half of those randomized to AMB 2.5 mg were titrated to 5 mg and 10 mg.
440507|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440508|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440509|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440510|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
440511|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440512|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440513|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440514|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
440656|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
440516|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440517|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440518|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
440519|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440520|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440521|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440522|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
440523|NCT00578786|O1|Outcome|Combined Ambrisentan Group|(All Doses)
440524|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
440525|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
440526|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
440527|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440528|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440529|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440530|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
440531|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440532|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440533|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440534|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
440535|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440536|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440537|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440538|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
440539|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440540|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440541|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440542|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
440543|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440544|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440545|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440546|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
440547|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440548|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440549|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440550|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
440551|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440552|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440753|NCT00584987|B4|Baseline|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440553|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440554|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
440555|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440556|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440557|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440558|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
440559|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440560|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440561|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440562|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
440563|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440564|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440565|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440566|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
440567|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440568|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440569|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440570|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
440571|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440572|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440573|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440574|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440575|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440576|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440577|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
440578|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440579|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440580|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440581|NCT00578786|E3|Reported Event|Ambrisentan 10 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440582|NCT00578786|E2|Reported Event|Ambrisentan 5 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440583|NCT00578786|E1|Reported Event|Ambrisentan 2.5 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
440584|NCT00578812|B3|Baseline|Total|Total of all reporting groups
440585|NCT00578812|B2|Baseline|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440586|NCT00578812|B1|Baseline|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440587|NCT00578812|P2|Participant Flow|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440588|NCT00578812|P1|Participant Flow|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440589|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440590|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440591|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440592|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440593|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440594|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440595|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440596|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440597|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440598|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440599|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440600|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440601|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440602|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440603|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440604|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440605|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440606|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440607|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440608|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440609|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440610|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440611|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440612|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440613|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440614|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440615|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440616|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440617|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440619|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440620|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440621|NCT00578812|E2|Reported Event|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440622|NCT00578812|E1|Reported Event|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
440623|NCT00578864|B3|Baseline|Total|Total of all reporting groups
440624|NCT00578864|B2|Baseline|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
440625|NCT00578864|B1|Baseline|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
440626|NCT00578864|P2|Participant Flow|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
440627|NCT00578864|P1|Participant Flow|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
440628|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
440629|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
440630|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
440631|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
440632|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
440633|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
440634|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
440635|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
440636|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
440637|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
440638|NCT00578864|E2|Reported Event|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
440639|NCT00578864|E1|Reported Event|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
440640|NCT00578877|B3|Baseline|Total|Total of all reporting groups
440641|NCT00578877|B2|Baseline|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
440642|NCT00578877|B1|Baseline|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
440643|NCT00578877|P2|Participant Flow|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
440644|NCT00578877|P1|Participant Flow|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
440645|NCT00578877|O2|Outcome|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
440646|NCT00578877|O1|Outcome|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
440647|NCT00578877|E2|Reported Event|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
440648|NCT00578877|E1|Reported Event|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
440649|NCT00578903|B1|Baseline|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
440650|NCT00578903|P1|Participant Flow|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
440651|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
440652|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
440653|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
440654|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
440655|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
440870|NCT00587041|B4|Baseline|Total|Total of all reporting groups
440657|NCT00578903|E1|Reported Event|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
440658|NCT00578929|B5|Baseline|Total|Total of all reporting groups
440659|NCT00578929|B4|Baseline|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
440660|NCT00578929|B3|Baseline|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
440661|NCT00578929|B2|Baseline|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
440662|NCT00578929|B1|Baseline|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
440663|NCT00578929|P4|Participant Flow|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
440664|NCT00578929|P3|Participant Flow|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
440665|NCT00578929|P2|Participant Flow|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
440666|NCT00578929|P1|Participant Flow|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
440667|NCT00578929|O4|Outcome|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
440668|NCT00578929|O3|Outcome|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
440669|NCT00578929|O2|Outcome|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
440670|NCT00578929|O1|Outcome|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
440671|NCT00578929|O4|Outcome|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
440672|NCT00578929|O3|Outcome|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
440673|NCT00578929|O2|Outcome|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
440674|NCT00578929|O1|Outcome|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
440675|NCT00578929|E5|Reported Event|Vehicle Run-in Period|Vehicle Run-in Period
440676|NCT00578929|E4|Reported Event|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
440677|NCT00578929|E3|Reported Event|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
440678|NCT00578929|E2|Reported Event|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
440679|NCT00578929|E1|Reported Event|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
440680|NCT00578942|B1|Baseline|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Patient Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
440681|NCT00578942|P1|Participant Flow|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
440682|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
440683|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
440684|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
440685|NCT00578942|E1|Reported Event|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors
Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
440686|NCT00578968|B4|Baseline|Total|Total of all reporting groups
442763|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
440687|NCT00578968|B3|Baseline|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
440688|NCT00578968|B2|Baseline|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440689|NCT00578968|B1|Baseline|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440690|NCT00578968|P3|Participant Flow|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
440691|NCT00578968|P2|Participant Flow|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440692|NCT00578968|P1|Participant Flow|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440693|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440694|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440695|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440696|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440697|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440698|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440699|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440700|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440701|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440702|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440703|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440704|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440705|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440706|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440707|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440708|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440709|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440710|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440711|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440712|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440713|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440714|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440715|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440716|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440717|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440718|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440719|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440720|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
442764|NCT00594425|O3|Outcome|Vehicle PDT|
440721|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440722|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440723|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440724|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440725|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440726|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440727|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
440728|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
440729|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
440730|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
440731|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440732|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440733|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
440734|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
440735|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
440736|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
440737|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
440738|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
440739|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
440740|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
440741|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
440742|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
440743|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
440744|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
440745|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
440746|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
440747|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
440748|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
440749|NCT00578968|E3|Reported Event|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
440750|NCT00578968|E2|Reported Event|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
440751|NCT00578968|E1|Reported Event|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
440752|NCT00584987|B5|Baseline|Total|Total of all reporting groups
442765|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
442766|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
440756|NCT00584987|B1|Baseline|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440757|NCT00584987|P4|Participant Flow|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440758|NCT00584987|P3|Participant Flow|PL FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440759|NCT00584987|P2|Participant Flow|FF + PL OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440760|NCT00584987|P1|Participant Flow|PL FF + PL OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440761|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440762|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440763|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440764|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440765|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440766|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440767|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440768|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440769|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440770|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440771|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440772|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440773|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440774|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440775|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440776|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440777|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440778|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440779|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440780|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440781|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440782|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440783|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440784|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440785|NCT00584987|E4|Reported Event|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440786|NCT00584987|E3|Reported Event|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440787|NCT00584987|E2|Reported Event|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440788|NCT00584987|E1|Reported Event|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
440789|NCT00585013|B3|Baseline|Total|Total of all reporting groups
440790|NCT00585013|B2|Baseline|2 Placebo|Placebo delivery of oxygen at standard dose.
440791|NCT00585013|B1|Baseline|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
440792|NCT00585013|P2|Participant Flow|2 Placebo|Placebo delivery of oxygen at standard dose.
440793|NCT00585013|P1|Participant Flow|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
440794|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
440795|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
440796|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
440797|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
440798|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
440799|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
440800|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
440801|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
440802|NCT00585013|O2|Outcome|Placebo|Placebo delivery of oxygen at standard dose.
440803|NCT00585013|O1|Outcome|Nitric Oxide Delivery Group|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide: Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
440804|NCT00585013|E2|Reported Event|2 Placebo|Placebo delivery of oxygen at standard dose.
440805|NCT00585013|E1|Reported Event|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
440806|NCT00585039|B3|Baseline|Total|Total of all reporting groups
440807|NCT00585039|B2|Baseline|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
440808|NCT00585039|B1|Baseline|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
440809|NCT00585039|P2|Participant Flow|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
440810|NCT00585039|P1|Participant Flow|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
440811|NCT00585039|O2|Outcome|Albuterol|
440812|NCT00585039|O1|Outcome|Levalbuterol|
440813|NCT00585039|O2|Outcome|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
440814|NCT00585039|O1|Outcome|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
440815|NCT00585039|E2|Reported Event|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
440816|NCT00585039|E1|Reported Event|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
440817|NCT00585078|B1|Baseline|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
440818|NCT00585078|P1|Participant Flow|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
440819|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
440820|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
440821|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
440867|NCT00586898|P1|Participant Flow|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
440868|NCT00586898|O1|Outcome|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
442767|NCT00594425|O3|Outcome|Vehicle PDT|
442768|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
440822|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
440823|NCT00585078|E1|Reported Event|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
440824|NCT00585104|B1|Baseline|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
440825|NCT00585104|P1|Participant Flow|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
440826|NCT00585104|O1|Outcome|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
440827|NCT00585104|E1|Reported Event|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
440828|NCT00585169|B1|Baseline|Memantine|"10 to 30 mg/day memantine
Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
440829|NCT00585169|P1|Participant Flow|Memantine|"10 to 30 mg/day memantine
Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
440830|NCT00585169|O1|Outcome|Memantine|"10 to 30 mg/day memantine
Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
440831|NCT00585169|E3|Reported Event|Memantine 30mg|
440832|NCT00585169|E2|Reported Event|Memantine 20mg|
440833|NCT00585169|E1|Reported Event|Memantine 10mg|
440834|NCT00585182|B1|Baseline|Enoxaparin 0.5mg/kg Once Daily|
440835|NCT00585182|P1|Participant Flow|Enoxaparin 0.5mg/kg Once Daily|
440836|NCT00585182|O1|Outcome|Enoxaparin 0.5mg/kg Once Daily|
440837|NCT00585182|O1|Outcome|Enoxaparin 0.5mg/kg Once Daily|
440838|NCT00585182|E1|Reported Event|Enoxaparin 0.5mg/kg Once Daily|
440839|NCT00585221|B1|Baseline|Group 1|
440840|NCT00585221|P1|Participant Flow|All Patients|All participants enrolled.
440841|NCT00585221|O1|Outcome|All Patients|All participants enrolled
440842|NCT00585221|O1|Outcome|All Patients|All participants enrolled
440843|NCT00585221|E1|Reported Event|All Enrolled|All participants enrolled
440844|NCT00585286|B1|Baseline|Fractional CO2 Laser System|Thirty healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
440845|NCT00585286|P1|Participant Flow|Fractional Carbon Dioxide Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional carbon dioxide laser system.
440846|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
440847|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
440848|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
440849|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
440850|NCT00585286|E1|Reported Event|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
440851|NCT00585312|B3|Baseline|Total|Total of all reporting groups
440852|NCT00585312|B2|Baseline|Placebo|Matching placebo
440853|NCT00585312|B1|Baseline|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
440854|NCT00585312|P2|Participant Flow|Placebo|Matching placebo
440855|NCT00585312|P1|Participant Flow|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
440856|NCT00585312|O2|Outcome|Placebo|Matching placebo
440857|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
440858|NCT00585312|O2|Outcome|Placebo|Matching placebo
440859|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
440860|NCT00585312|O2|Outcome|Placebo|Matching placebo
440861|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
440862|NCT00585312|O2|Outcome|Placebo|Matching placebo
440863|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
440864|NCT00585312|E2|Reported Event|Placebo|Matching placebo
440865|NCT00585312|E1|Reported Event|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
440866|NCT00586898|B1|Baseline|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
442769|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
440871|NCT00587041|B3|Baseline|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
440872|NCT00587041|B2|Baseline|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
440873|NCT00587041|B1|Baseline|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
440874|NCT00587041|P3|Participant Flow|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
440875|NCT00587041|P2|Participant Flow|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
440876|NCT00587041|P1|Participant Flow|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
440877|NCT00587041|O3|Outcome|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
440878|NCT00587041|O2|Outcome|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
440879|NCT00587041|O1|Outcome|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
440880|NCT00587041|O3|Outcome|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
440881|NCT00587041|O2|Outcome|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
440882|NCT00587041|O1|Outcome|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
440883|NCT00587041|E3|Reported Event|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
440884|NCT00587041|E2|Reported Event|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
440885|NCT00587041|E1|Reported Event|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
440886|NCT00587054|B1|Baseline|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
440887|NCT00587054|P1|Participant Flow|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
440888|NCT00587054|O1|Outcome|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
440889|NCT00587054|E1|Reported Event|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
440890|NCT00587067|B1|Baseline|Floxuridine + Dexamethasone|"FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate
* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."
440891|NCT00587067|P1|Participant Flow|Floxuridine + Dexamethasone|"FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate
* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."
440892|NCT00587067|O1|Outcome|Floxuridine + Dexamethasone|Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.
440893|NCT00587067|O1|Outcome|Floxuridine + Dexamethasone|Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.
440894|NCT00587067|O1|Outcome|Floxuridine + Dexamethasone|Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.
440917|NCT00587158|P1|Participant Flow|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440895|NCT00587067|E1|Reported Event|Floxuridine + Dexamethasone|"FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate
* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."
440896|NCT00587132|B5|Baseline|Total|Total of all reporting groups
440897|NCT00587132|B4|Baseline|Clinical Symptoms of Pancreatic Cancer, Normal CT|10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
440898|NCT00587132|B3|Baseline|Peutz-Jeghers Syndrome|"10 adults age 35-99 with Peutz-Jeghers syndrome.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440899|NCT00587132|B2|Baseline|Familial Pancreatic Cancer|"10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440900|NCT00587132|B1|Baseline|New Onset Diabetes|"10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440901|NCT00587132|P4|Participant Flow|Clinical Symptoms of Pancreatic Cancer, Normal CT|Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
440902|NCT00587132|P3|Participant Flow|Peutz-Jeghers Syndrome|"Adults age 35-99 with Peutz-Jeghers syndrome.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440903|NCT00587132|P2|Participant Flow|Familial Pancreatic Cancer|"Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440904|NCT00587132|P1|Participant Flow|New Onset Diabetes|"Adults diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440905|NCT00587132|O4|Outcome|Clinical Symptoms of Pancreatic Cancer, Normal CT|"Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440906|NCT00587132|O3|Outcome|Peutz-Jeghers Syndrome|"Adults age 35-99 with Peutz-Jeghers syndrome.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440907|NCT00587132|O2|Outcome|Familial Pancreatic Cancer|"Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440908|NCT00587132|O1|Outcome|New Onset Diabetes|"Adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440909|NCT00587132|E4|Reported Event|Clinical Symptoms of Pancreatic Cancer, Normal CT|10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
440910|NCT00587132|E3|Reported Event|Peutz-Jeghers Syndrome|"10 adults age 35-99 with Peutz-Jeghers syndrome.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440911|NCT00587132|E2|Reported Event|Familial Pancreatic Cancer|"10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440912|NCT00587132|E1|Reported Event|New Onset Diabetes|"10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.
All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
440913|NCT00587158|B3|Baseline|Total|Total of all reporting groups
440914|NCT00587158|B2|Baseline|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440915|NCT00587158|B1|Baseline|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440916|NCT00587158|P2|Participant Flow|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive therapy consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®). In addition, subjects in this group will receive the study medication paricalcitol (Zemplar®).
441099|NCT00587587|P2|Participant Flow|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
440918|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440919|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440920|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440921|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440922|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440923|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440924|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440925|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440926|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440927|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440928|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440929|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440930|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440931|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440932|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440933|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440934|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440935|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440936|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440937|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440938|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440939|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440940|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440941|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
441144|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
440942|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440943|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440944|NCT00587158|E2|Reported Event|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
440945|NCT00587158|E1|Reported Event|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
440946|NCT00587171|B3|Baseline|Total|Total of all reporting groups
440947|NCT00587171|B2|Baseline|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440948|NCT00587171|B1|Baseline|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440949|NCT00587171|P2|Participant Flow|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440950|NCT00587171|P1|Participant Flow|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440951|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440952|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440953|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440954|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440955|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440956|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440957|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440958|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440959|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440960|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440961|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440962|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440963|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440964|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440965|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440966|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440967|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440968|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440969|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440970|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440971|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440972|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440973|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
442770|NCT00594425|O3|Outcome|Vehicle PDT|
440974|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440975|NCT00587171|E2|Reported Event|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
440976|NCT00587171|E1|Reported Event|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
440977|NCT00587223|B1|Baseline|Apligraf/Control|Apligraf (a living bilayered cell therapy product) Control (a primary nonadherent dressing, nonstick gauze, retainer dressing)
440978|NCT00587223|P1|Participant Flow|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
440979|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
440980|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
440981|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
440982|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
440983|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
440984|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
440985|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
440986|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
440987|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesions receive standard wound dressings.
440988|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
440989|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesion receives standard wound dressings.
440990|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
440991|NCT00587223|E1|Reported Event|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
440992|NCT00587288|B3|Baseline|Total|Total of all reporting groups
440993|NCT00587288|B2|Baseline|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
440994|NCT00587288|B1|Baseline|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
440995|NCT00587288|P2|Participant Flow|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
440996|NCT00587288|P1|Participant Flow|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
440997|NCT00587288|O2|Outcome|Placebo|Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
440998|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
440999|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441000|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441001|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441002|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441003|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441004|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441005|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441006|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441007|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441008|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441009|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441010|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441011|NCT00587288|E2|Reported Event|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441012|NCT00587288|E1|Reported Event|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
441013|NCT00587431|B3|Baseline|Total|Total of all reporting groups
441014|NCT00587431|B2|Baseline|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
441015|NCT00587431|B1|Baseline|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
441016|NCT00587431|P2|Participant Flow|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
441017|NCT00587431|P1|Participant Flow|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
441018|NCT00587431|O1|Outcome|All Participants|All participants
441019|NCT00587431|O4|Outcome|Lupron + Docetaxel (70 mg/m2) + Testosterone (Metastatic)|"(Metastatic) GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
441020|NCT00587431|O3|Outcome|Lupron +Docetaxel (70 mg/m2) +Testosterone (RISING PSA)|"GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
441021|NCT00587431|O2|Outcome|Lupron + Docetaxel (75mg/m2) + Testosterone for (Metastatic)|"GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
441022|NCT00587431|O1|Outcome|Lupron + Docetaxel (75mg/m2) +Testosterone (RISING PSA)|"GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
441023|NCT00587431|E2|Reported Event|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
441024|NCT00587431|E1|Reported Event|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
441025|NCT00587457|B4|Baseline|Total|Total of all reporting groups
441026|NCT00587457|B3|Baseline|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441027|NCT00587457|B2|Baseline|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441028|NCT00587457|B1|Baseline|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441029|NCT00587457|P3|Participant Flow|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441030|NCT00587457|P2|Participant Flow|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441031|NCT00587457|P1|Participant Flow|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441032|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441033|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441034|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441035|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441036|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441037|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441038|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441039|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
442771|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
441040|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441041|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441042|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441043|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441044|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441045|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441046|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441047|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441048|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441049|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441050|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441051|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441052|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441053|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441054|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441055|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441056|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441057|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441058|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441059|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441060|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441061|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441062|NCT00587457|E3|Reported Event|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441063|NCT00587457|E2|Reported Event|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441064|NCT00587457|E1|Reported Event|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
441065|NCT00587483|B4|Baseline|Total|Total of all reporting groups
441066|NCT00587483|B3|Baseline|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441067|NCT00587483|B2|Baseline|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441068|NCT00587483|B1|Baseline|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441069|NCT00587483|P3|Participant Flow|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441070|NCT00587483|P2|Participant Flow|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441071|NCT00587483|P1|Participant Flow|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441072|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441073|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441074|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441075|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441076|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441077|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441078|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441079|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441080|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441081|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441082|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441083|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441084|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441085|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441086|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441087|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441088|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441089|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441090|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441091|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441092|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441093|NCT00587483|E3|Reported Event|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441094|NCT00587483|E2|Reported Event|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441095|NCT00587483|E1|Reported Event|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
441096|NCT00587587|B3|Baseline|Total|Total of all reporting groups
441097|NCT00587587|B2|Baseline|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441098|NCT00587587|B1|Baseline|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441100|NCT00587587|P1|Participant Flow|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441101|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441102|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441103|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441104|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441105|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441106|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441107|NCT00587587|O2|Outcome|B (Control)|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441108|NCT00587587|O1|Outcome|A (Apligraf)|Apligraf (bilayered living cell therapy)
441109|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441110|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441111|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441112|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441113|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441114|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441115|NCT00587587|O2|Outcome|B (Control)|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441116|NCT00587587|O1|Outcome|A (Apligraf)|Apligraf (bilayered living cell therapy)
441117|NCT00587587|E2|Reported Event|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441118|NCT00587587|E1|Reported Event|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
441119|NCT00587639|B1|Baseline|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
441120|NCT00587639|P1|Participant Flow|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
441121|NCT00587639|O1|Outcome|rTMS Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
441122|NCT00587639|O1|Outcome|rTMS Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
441123|NCT00587639|E1|Reported Event|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
441124|NCT00587678|B4|Baseline|Total|Total of all reporting groups
441125|NCT00587678|B3|Baseline|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441126|NCT00587678|B2|Baseline|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441127|NCT00587678|B1|Baseline|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441128|NCT00587678|P3|Participant Flow|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441129|NCT00587678|P2|Participant Flow|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441130|NCT00587678|P1|Participant Flow|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441131|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441132|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441133|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441134|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441135|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441136|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441137|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441138|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441139|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441140|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441141|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441142|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441143|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441145|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441146|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441147|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441148|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441149|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441150|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441151|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441152|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441153|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441154|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441155|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441156|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441157|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441158|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441159|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441160|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441161|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441162|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441163|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441164|NCT00587678|E3|Reported Event|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
441165|NCT00587678|E2|Reported Event|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
441166|NCT00587678|E1|Reported Event|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
441167|NCT00587769|B1|Baseline|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
441168|NCT00587769|P1|Participant Flow|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
441169|NCT00587769|O1|Outcome|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
441170|NCT00587769|O1|Outcome|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
441171|NCT00587769|E1|Reported Event|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
441172|NCT00587795|B3|Baseline|Total|Total of all reporting groups
441173|NCT00587795|B2|Baseline|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.
Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
441174|NCT00587795|B1|Baseline|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.
StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
441175|NCT00587795|P2|Participant Flow|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.
Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
441176|NCT00587795|P1|Participant Flow|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.
StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
441177|NCT00587795|O2|Outcome|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.
Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
441178|NCT00587795|O1|Outcome|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.
StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
441179|NCT00587795|E2|Reported Event|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.
Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
441180|NCT00587795|E1|Reported Event|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.
StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
441181|NCT00587834|B1|Baseline|Gintuit and Autologous Free Gingival Graft (FGG)|Single application of Gintuit and FGG (control); split-mouth design
441182|NCT00587834|P1|Participant Flow|Gintuit and Autologous Free Gingival Graft (FGG)|Single application of Gintuit and FGG (control); split-mouth design
441183|NCT00587834|O2|Outcome|Gintuit Sensitive|Included ratings of Moderate and Severe
441184|NCT00587834|O1|Outcome|Gintuit Not Sensitive|Included ratings of None and Mild
442772|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
442773|NCT00594425|O3|Outcome|Vehicle PDT|
441185|NCT00587834|O1|Outcome|Gintuit|Single application of Gintuit and FGG (control); split-mouth design. Number of subjects preferring Gintuit over Control.
441186|NCT00587834|O1|Outcome|Gintuit|Single application;split-mouth design
441187|NCT00587834|O2|Outcome|Gintuit Not Equally Firm as Adjacent Tissue|"Not Equally Firm includes responses of less firm and more firm"
441188|NCT00587834|O1|Outcome|Gintuit Equally Firm as Adjacent Tissue|
441189|NCT00587834|O2|Outcome|Gintuit Not Equally Red as Adjacent Tissue|"Not Equally Red includes responses of more red and less red"
441190|NCT00587834|O1|Outcome|Gintuit Equally Red as Adjacent Tissue|
441191|NCT00587834|O1|Outcome|Gintuit|Single application;split-mouth design
441192|NCT00587834|E5|Reported Event|Other|Adverse events occurring at any other location in the body or systemic conditions
441193|NCT00587834|E4|Reported Event|Mouth|Adverse events occurring in the mouth and not localized to the Gintuit, FGG, or palatal donation sites.
441194|NCT00587834|E3|Reported Event|Palatal Donation Site|Adverse events occurring at the palatal donation site
441195|NCT00587834|E2|Reported Event|Free Gingival Graft|Adverse events occurring at the autologous free gingival graft site
441196|NCT00587834|E1|Reported Event|Gintuit|Adverse events occurring at the Gintuit treated site
441197|NCT00587847|B1|Baseline|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
441198|NCT00587847|P1|Participant Flow|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
441199|NCT00587847|O1|Outcome|All Participants|All participants were included in the safety analysis.
441200|NCT00587847|O1|Outcome|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
441201|NCT00587847|E1|Reported Event|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
441202|NCT00587860|B3|Baseline|Total|Total of all reporting groups
441203|NCT00587860|B2|Baseline|Placebo|Placebo, twice a day
441204|NCT00587860|B1|Baseline|St. John's Wort|St. John's Wort, 450 mg twice a day
441205|NCT00587860|P2|Participant Flow|Placebo|Placebo, twice a day
441206|NCT00587860|P1|Participant Flow|St. John's Wort|St. John's Wort, 450 mg twice a day
441207|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
441208|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
441209|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
441210|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
441211|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
441212|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
441213|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
441214|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
441215|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
441216|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
441217|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
441218|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
441219|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
441220|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
441221|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
441222|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
441223|NCT00587860|E2|Reported Event|Placebo|Placebo, twice a day
441224|NCT00587860|E1|Reported Event|St. John's Wort|St. John's Wort, 450 mg twice a day
441225|NCT00587964|B1|Baseline|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
441226|NCT00587964|P1|Participant Flow|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
441227|NCT00587964|O1|Outcome|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
441228|NCT00587964|E1|Reported Event|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
441229|NCT00587990|B4|Baseline|Total|Total of all reporting groups
441230|NCT00587990|B3|Baseline|(3) Placebo|"Participants will receive placebo injections
Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
441231|NCT00587990|B2|Baseline|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells
Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
441232|NCT00587990|B1|Baseline|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells
Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
441233|NCT00587990|P3|Participant Flow|(3) Placebo Injection|"Participants will receive placebo injections
Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
441234|NCT00587990|P2|Participant Flow|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells
Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
441261|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
441262|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
441235|NCT00587990|P1|Participant Flow|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells
Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
441236|NCT00587990|O3|Outcome|(3) Placebo Injection|"Participants will receive placebo injections
Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
441237|NCT00587990|O2|Outcome|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells
Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
441238|NCT00587990|O1|Outcome|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells
Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
441239|NCT00587990|E3|Reported Event|(3) Placebo Injection|"Participants will receive placebo injections
Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
441240|NCT00587990|E2|Reported Event|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells
Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
441241|NCT00587990|E1|Reported Event|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells
Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
441242|NCT00588094|B1|Baseline|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
441243|NCT00588094|P1|Participant Flow|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
441244|NCT00588094|O1|Outcome|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
441245|NCT00588094|E1|Reported Event|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
441246|NCT00588146|B1|Baseline|Entire Study Population|Includes groups randomized to pegylated interferon alpha-2b first and standard care first.
441247|NCT00588146|P2|Participant Flow|Standard Care, Then Pegylated Interferon Alpha2b|Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
441248|NCT00588146|P1|Participant Flow|Pegylated Interferon Alpha2b, Then Standard Care|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
441249|NCT00588146|O2|Outcome|Standard Care, Then Pegylated Interferon Alpha2b|Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
441250|NCT00588146|O1|Outcome|Pegylated Interferon Alpha2b, Then Standard Care|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
441251|NCT00588146|E2|Reported Event|Standard Care|Subjects received standard care for hereditary hemorrhagic telangiectasia.
441252|NCT00588146|E1|Reported Event|Pegylated Interferon Alpha-2b|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week
441253|NCT00588159|B3|Baseline|Total|Total of all reporting groups
441254|NCT00588159|B2|Baseline|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
441255|NCT00588159|B1|Baseline|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
441256|NCT00588159|P2|Participant Flow|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
441257|NCT00588159|P1|Participant Flow|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
441258|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
441259|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
441260|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
442774|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
441263|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
441264|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
441265|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
441266|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
441267|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
441268|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
441269|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
441270|NCT00588159|E2|Reported Event|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
441271|NCT00588159|E1|Reported Event|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
441272|NCT00588237|B1|Baseline|All Patients|Paclitaxel, Cisplatin, Bevacizumab
441273|NCT00588237|P1|Participant Flow|All Patients|Paclitaxel, Cisplatin, Bevacizumab
441274|NCT00588237|O1|Outcome|All Patients|Paclitaxel, Cisplatin, Bevacizumab
441275|NCT00588237|E1|Reported Event|All Patients|Paclitaxel, Cisplatin, Bevacizumab
441276|NCT00588341|B1|Baseline|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
441277|NCT00588341|P1|Participant Flow|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
441278|NCT00588341|O1|Outcome|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
441279|NCT00588341|E1|Reported Event|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
441280|NCT00588354|B3|Baseline|Total|Total of all reporting groups
441281|NCT00588354|B2|Baseline|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.
The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
441282|NCT00588354|B1|Baseline|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.
The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
441283|NCT00588354|P2|Participant Flow|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.
The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
441284|NCT00588354|P1|Participant Flow|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.
The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
441285|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
441286|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
441287|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
441288|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
441289|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
441290|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
441291|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
441292|NCT00588354|O1|Outcome|2% Lidocaine and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
441293|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
441294|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
441295|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
441296|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
441297|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
441298|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
441299|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
441300|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
441301|NCT00588354|E2|Reported Event|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.
The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
441302|NCT00588354|E1|Reported Event|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.
The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
441303|NCT00588380|B1|Baseline|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
441327|NCT00588471|B1|Baseline|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
441304|NCT00588380|P1|Participant Flow|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
441305|NCT00588380|O1|Outcome|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
441306|NCT00588380|O1|Outcome|All Participants|C-peptide as a marker of insulin secretion
441307|NCT00588380|E1|Reported Event|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
441308|NCT00588406|B3|Baseline|Total|Total of all reporting groups
441309|NCT00588406|B2|Baseline|Placebo|"Placebo plus standard care
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO"
441310|NCT00588406|B1|Baseline|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care
Budesonide: 2mg/dose by nebulizer, four doses over 3 hours
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO"
441311|NCT00588406|P2|Participant Flow|Placob|"Placebo plus standard care
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO"
441312|NCT00588406|P1|Participant Flow|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care
Budesonide: 2mg/dose by nebulizer, four doses over 3 hours
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO"
441313|NCT00588406|O2|Outcome|Placebo|"Placebo plus standard care
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO"
441314|NCT00588406|O1|Outcome|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care
Budesonide: 2mg/dose by nebulizer, four doses over 3 hours
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO"
441315|NCT00588406|O2|Outcome|Placebo|"Placebo plus standard care
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO"
441316|NCT00588406|O1|Outcome|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care
Budesonide: 2mg/dose by nebulizer, four doses over 3 hours
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO"
441317|NCT00588406|E2|Reported Event|Placebo|"Placebo plus standard care
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO"
441318|NCT00588406|E1|Reported Event|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care
Budesonide: 2mg/dose by nebulizer, four doses over 3 hours
albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours
Ipratropium bromide: 2.5 mg, one dose
Prednisone: 60mg PO"
441319|NCT00588445|B1|Baseline|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.
Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.
Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
441320|NCT00588445|P1|Participant Flow|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.
Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.
Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
441321|NCT00588445|O2|Outcome|EGFR Mutation Negative|Tumor specimens analyzed for EGFR mutation
441322|NCT00588445|O1|Outcome|EGFR Mutation Positive|Tumor specimens analyzed for EGFR mutation
441323|NCT00588445|O1|Outcome|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.
Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.
Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
441324|NCT00588445|E1|Reported Event|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.
Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.
Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
441325|NCT00588471|B3|Baseline|Total|Total of all reporting groups
441326|NCT00588471|B2|Baseline|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
441328|NCT00588471|P2|Participant Flow|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
441329|NCT00588471|P1|Participant Flow|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
441330|NCT00588471|O2|Outcome|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
441331|NCT00588471|O1|Outcome|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
441332|NCT00588471|O2|Outcome|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
441333|NCT00588471|O1|Outcome|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
441334|NCT00588471|E2|Reported Event|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
441335|NCT00588471|E1|Reported Event|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
441336|NCT00588536|B1|Baseline|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs
6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.
Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
441337|NCT00588536|P1|Participant Flow|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs
6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.
Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
441338|NCT00588536|O1|Outcome|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs
6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.
Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
441339|NCT00588536|E1|Reported Event|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs
6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.
Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
441340|NCT00588640|B1|Baseline|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
441341|NCT00588640|P1|Participant Flow|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
441342|NCT00588640|O1|Outcome|Phase I, Cohort l|"oral d-methadone 40 mg
d-Methadone: 8 subjects to receive 40 mg d-Methadone twice a day"
441343|NCT00588640|E1|Reported Event|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
441344|NCT00588666|B1|Baseline|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
441345|NCT00588666|P1|Participant Flow|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
441346|NCT00588666|O1|Outcome|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
441347|NCT00588666|O1|Outcome|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
441390|NCT00588731|B1|Baseline|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
441391|NCT00588731|P2|Participant Flow|Placebo|Placebo: Placebo
441348|NCT00588666|E1|Reported Event|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
441349|NCT00588692|B3|Baseline|Total|Total of all reporting groups
441350|NCT00588692|B2|Baseline|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441351|NCT00588692|B1|Baseline|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441352|NCT00588692|P2|Participant Flow|SphygmoCor Blinded|"Sphygmocor values will be blinded to the investigator.
SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
441353|NCT00588692|P1|Participant Flow|SphygmoCor Unblinded|"The use of the sphygmocor values will determine medication adjustments to optimize heart failure (HF) treatment.
SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
441354|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441355|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441356|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441357|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441358|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441359|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441360|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441361|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441362|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441363|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441364|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441365|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441366|NCT00588692|O2|Outcome|Control|Sphygmocor values will be blinded to the investigator.
441367|NCT00588692|O1|Outcome|Treatment|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441368|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441369|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441370|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441371|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441372|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441373|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441374|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441375|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441376|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441377|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441378|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441379|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441380|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441381|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441382|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441383|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441384|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
441385|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
441386|NCT00588692|E2|Reported Event|Control|"Sphygmocor values will be blinded to the investigator.
SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
441387|NCT00588692|E1|Reported Event|Treatment|"The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
441388|NCT00588731|B3|Baseline|Total|Total of all reporting groups
441389|NCT00588731|B2|Baseline|Placebo|Placebo: Placebo
441399|NCT00588809|B1|Baseline|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
selumetinib: Given PO"
441400|NCT00588809|P1|Participant Flow|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
selumetinib: Given PO"
441401|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
selumetinib: Given PO"
441402|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
selumetinib: Given PO"
441403|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
selumetinib: Given PO"
441404|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
selumetinib: Given PO"
441405|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
selumetinib: Given PO"
441406|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
selumetinib: Given PO"
441407|NCT00588809|E1|Reported Event|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
selumetinib: Given PO"
441408|NCT00588822|B1|Baseline|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.
Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
441409|NCT00588822|P1|Participant Flow|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.
Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
441410|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.
Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
441411|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.
Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
441412|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.
Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
441413|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.
Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
441414|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.
Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
441415|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.
Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
441416|NCT00588822|E1|Reported Event|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.
Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
441417|NCT00588848|B3|Baseline|Total|Total of all reporting groups
441418|NCT00588848|B2|Baseline|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)
Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
441419|NCT00588848|B1|Baseline|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)
Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
441420|NCT00588848|P2|Participant Flow|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)
Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
441448|NCT00588952|P2|Participant Flow|Family History Negative|"Subjects with a negative family history of alcoholism
Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
441421|NCT00588848|P1|Participant Flow|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)
Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
441422|NCT00588848|O2|Outcome|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)
Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
441423|NCT00588848|O1|Outcome|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)
Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
441424|NCT00588848|O2|Outcome|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)
Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
441425|NCT00588848|O1|Outcome|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)
Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
441426|NCT00588848|E2|Reported Event|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)
Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
441427|NCT00588848|E1|Reported Event|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)
Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
441428|NCT00588861|B3|Baseline|Total|Total of all reporting groups
441429|NCT00588861|B2|Baseline|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
441430|NCT00588861|B1|Baseline|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
441431|NCT00588861|P2|Participant Flow|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
441432|NCT00588861|P1|Participant Flow|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
441433|NCT00588861|O2|Outcome|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
441434|NCT00588861|O1|Outcome|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
441435|NCT00588861|O2|Outcome|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
441436|NCT00588861|O1|Outcome|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
441437|NCT00588861|E2|Reported Event|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
441438|NCT00588861|E1|Reported Event|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
441439|NCT00588900|B1|Baseline|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
441440|NCT00588900|P1|Participant Flow|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
441441|NCT00588900|O1|Outcome|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
441442|NCT00588900|O1|Outcome|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
441443|NCT00588900|O1|Outcome|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
441444|NCT00588900|E1|Reported Event|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
441445|NCT00588952|B3|Baseline|Total|Total of all reporting groups
441446|NCT00588952|B2|Baseline|Family History Negative|"Subjects with a negative family history of alcoholism
Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
441447|NCT00588952|B1|Baseline|Family History Positive|"Subjects with a positive family history of alcoholism
Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
441481|NCT00589108|P2|Participant Flow|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
441449|NCT00588952|P1|Participant Flow|Family History Positive|"Subjects with a positive family history of alcoholism
Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
441450|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441451|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441452|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441453|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441454|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441455|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441456|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441457|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441458|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441459|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441460|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441461|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441462|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441463|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441464|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441465|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441466|NCT00588952|E2|Reported Event|Family History Negative|"Subjects with a negative family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441467|NCT00588952|E1|Reported Event|Family History Positive|"Subjects with a positive family history of alcoholism
Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
441468|NCT00588965|B1|Baseline|All Subjects|Subjects will take propranolol LA 80 mg or placebo daily for one week then propranolol LA 160 mg for one week or 2 placebo pills, followed by the exercise test. The participants will be randomized to one of 2 sequences: placebo first or propranolol first.
441469|NCT00588965|P1|Participant Flow|All Participants|All participants were randomized to one of 2 sequences, in which they received either propranolol first, then placebo, or placebo first, then propranolol.
441470|NCT00588965|O2|Outcome|Propranolol|
441471|NCT00588965|O1|Outcome|Placebo|
441472|NCT00588965|O2|Outcome|Propranolol|
441473|NCT00588965|O1|Outcome|Placebo|
441474|NCT00588965|E2|Reported Event|Propranolol|Subjects will take propranolol LA 80 mg daily for one week then 160 mg for one week followed by the exercise test.
441475|NCT00588965|E1|Reported Event|Placebo|Subjects are assigned to placebo.
441476|NCT00589108|B4|Baseline|Total|Total of all reporting groups
441477|NCT00589108|B3|Baseline|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
441478|NCT00589108|B2|Baseline|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
441479|NCT00589108|B1|Baseline|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
441480|NCT00589108|P3|Participant Flow|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
441482|NCT00589108|P1|Participant Flow|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
441483|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
441484|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
441485|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
441486|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
441487|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
441488|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
441489|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
441490|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
441491|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
441492|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
441493|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
441494|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
441495|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
441496|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
441497|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
441498|NCT00589108|E3|Reported Event|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
441499|NCT00589108|E2|Reported Event|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
441500|NCT00589108|E1|Reported Event|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
441501|NCT00589121|B3|Baseline|Total|Total of all reporting groups
441502|NCT00589121|B2|Baseline|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441503|NCT00589121|B1|Baseline|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441504|NCT00589121|P2|Participant Flow|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441505|NCT00589121|P1|Participant Flow|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441506|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441507|NCT00589121|O2|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441508|NCT00589121|O1|Outcome|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441509|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441510|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441511|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441512|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441513|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441514|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441515|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441516|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441517|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441518|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441519|NCT00589121|E2|Reported Event|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441520|NCT00589121|E1|Reported Event|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
441521|NCT00589277|B3|Baseline|Total|Total of all reporting groups
441522|NCT00589277|B2|Baseline|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
441523|NCT00589277|B1|Baseline|Standard Care Counseling|Standard care counseling + standard care print information
441617|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441524|NCT00589277|P2|Participant Flow|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
441525|NCT00589277|P1|Participant Flow|Standard Care Counseling|Standard care counseling + standard care print information
441526|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
441527|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
441528|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
441529|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
441530|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
441531|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
441532|NCT00589277|E2|Reported Event|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
441533|NCT00589277|E1|Reported Event|Standard Care Counseling|Standard care counseling + standard care print information
441534|NCT00589290|B1|Baseline|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
441535|NCT00589290|P1|Participant Flow|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
441536|NCT00589290|O2|Outcome|Thymic Patients|Poorly differentiated neoplasm
441537|NCT00589290|O1|Outcome|Thymoma Patients|Well differentiated neoplasm
441538|NCT00589290|O1|Outcome|Belinostat|1000 mg/m^2 day, 30 minute intravenous infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
441539|NCT00589290|O2|Outcome|Thymic Patients|Poorly differentiated neoplasm
441540|NCT00589290|O1|Outcome|Thymoma Patients|Well differentiated neoplasm
441541|NCT00589290|E1|Reported Event|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
441542|NCT00589303|B3|Baseline|Total|Total of all reporting groups
441543|NCT00589303|B2|Baseline|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
441544|NCT00589303|B1|Baseline|Drug Therapy|FDA approved rate and rhythm control drugs
441545|NCT00589303|P2|Participant Flow|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
441546|NCT00589303|P1|Participant Flow|Drug Therapy|FDA approved rate and rhythm control drugs
441547|NCT00589303|O2|Outcome|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
441548|NCT00589303|O1|Outcome|Drug Therapy|FDA approved rate and rhythm control drugs
441549|NCT00589303|E2|Reported Event|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
441550|NCT00589303|E1|Reported Event|Drug Therapy|FDA approved rate and rhythm control drugs
441551|NCT00576056|B1|Baseline|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
441552|NCT00576056|P1|Participant Flow|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
441553|NCT00576056|O1|Outcome|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
441554|NCT00576056|O1|Outcome|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
441618|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441740|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
441741|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
441555|NCT00576056|E1|Reported Event|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
441556|NCT00576147|B1|Baseline|CT Scan|The standard head CT done to head trauma patients
441557|NCT00576147|P1|Participant Flow|CT Scan|The standard head CT done to head trauma patients
441558|NCT00576147|O1|Outcome|CT Scan|The standard head CT done to head trauma patients
441559|NCT00576147|E1|Reported Event|CT Scan|The standard head CT done to head trauma patients
441560|NCT00576199|B1|Baseline|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
441561|NCT00576199|P1|Participant Flow|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
441562|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
441563|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
441564|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
441565|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
441566|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
441567|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
441568|NCT00576199|E1|Reported Event|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
441569|NCT00576251|B3|Baseline|Total|Total of all reporting groups
441570|NCT00576251|B2|Baseline|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
441571|NCT00576251|B1|Baseline|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
441572|NCT00576251|P2|Participant Flow|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
441573|NCT00576251|P1|Participant Flow|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
441574|NCT00576251|O2|Outcome|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
441575|NCT00576251|O1|Outcome|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
441576|NCT00576251|E2|Reported Event|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
441577|NCT00576251|E1|Reported Event|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
441578|NCT00576303|B1|Baseline|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
441579|NCT00576303|P1|Participant Flow|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the erythropoiesis stimulating agents (ESA) like epoetin alfa or beta dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks
441580|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
441581|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
441582|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
441736|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
441737|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-Seconds polymerization time
441583|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
441584|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
441585|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
441586|NCT00576303|E1|Reported Event|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
441587|NCT00576316|B1|Baseline|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
441588|NCT00576316|P1|Participant Flow|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
441589|NCT00576316|O1|Outcome|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
441590|NCT00576316|O1|Outcome|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
441591|NCT00576316|E1|Reported Event|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
441592|NCT00576381|B1|Baseline|Dosing Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.
Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
441593|NCT00576381|P1|Participant Flow|Neonatal Dose Escalation Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.
Cohort 1--0.25 mcg/kg loading dose, 0.2 mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
441594|NCT00576381|O1|Outcome|Neonates|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.
Cohort 1--0.25mcg/kg loading dose, 0.2mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
441595|NCT00576381|E1|Reported Event|Dosing Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.
Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
441596|NCT00576420|B4|Baseline|Total|Total of all reporting groups
441597|NCT00576420|B3|Baseline|Control Group|Manual compression with surgical gauze pads.
441598|NCT00576420|B2|Baseline|FS VH S/D 500 S-apr - 120 Seconds|FS VH S/D 500 s-apr, 120 - seconds polymerization time
441599|NCT00576420|B1|Baseline|FS VH S/D 500 S-apr - 60 Seconds|FS VH S/D 500 s-apr, 60 - seconds polymerization time
441600|NCT00576420|P3|Participant Flow|Control Group|Manual compression with surgical gauze pads.
441601|NCT00576420|P2|Participant Flow|FS VH S/D 500 S-apr - 120 Seconds|FS VH S/D 500 s-apr, 120 - seconds polymerization time
441602|NCT00576420|P1|Participant Flow|FS VH S/D 500 S-apr - 60 Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 - seconds polymerization time
441603|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
441604|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
441605|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
441606|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441607|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441608|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441609|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441610|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441611|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441612|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441613|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441614|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441615|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441616|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441619|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441620|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441621|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441622|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441623|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441624|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441625|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441626|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441627|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441628|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441629|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441630|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441631|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441632|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441633|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441634|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441635|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441636|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441637|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441638|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441639|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441640|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441641|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441642|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441643|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441644|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441645|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441646|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441647|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441648|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441649|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441650|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441651|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441652|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441653|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441654|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441655|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441656|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441657|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441658|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441738|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
441739|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
441659|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441660|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441661|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441662|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441663|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441664|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441665|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441666|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441667|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441668|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441669|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441670|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441671|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441672|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441673|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441674|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441675|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441676|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441677|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441678|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441679|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441680|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441681|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441682|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441683|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441684|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441685|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441686|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
441687|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441688|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441689|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441690|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
441691|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441692|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
441693|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
441694|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441695|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441696|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441697|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441698|NCT00576420|O12|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
441699|NCT00576420|O11|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441700|NCT00576420|O10|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441701|NCT00576420|O9|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441702|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
441703|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441704|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
441705|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
441706|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Intraoperative Day 0|Manual compression with surgical gauze pads
441707|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Intraoperative Day 0|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441708|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 120-seconds polymerization
441709|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 60-seconds polymerization
441710|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441711|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441712|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
441713|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
441714|NCT00576420|O12|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
441715|NCT00576420|O11|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441716|NCT00576420|O10|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
441717|NCT00576420|O9|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
441718|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
441719|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441720|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
441721|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
441722|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Intraoperative Day 0|Manual compression with surgical gauze pads
441723|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Intraoperative Day 0|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441724|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 120-seconds polymerization
441725|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr (FS), 60-seconds polymerization
441726|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441727|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr - All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time) (FS All):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441728|NCT00576420|O2|Outcome|FS VH S/D 500 S -Apr - 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization (FS 120)
441729|NCT00576420|O1|Outcome|FS VH S/D 500 S -Apr - 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization (FS 60)
441730|NCT00576420|O4|Outcome|Control Group|Manual compression with surgical gauze pads
441731|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441732|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
441733|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
441734|NCT00576420|O4|Outcome|Control Group|Manual compression with surgical gauze pads
441735|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr - All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time"
441742|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization.
441743|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
441744|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
441745|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
441746|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
441747|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
441748|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
441749|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
441750|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
441751|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
441752|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
441753|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
441754|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
441755|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
441756|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
441757|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
441758|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
441759|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
441760|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
441761|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr- 60-Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
441762|NCT00576420|E4|Reported Event|Control Group|Treatment of the study-suture line will be manual compression with surgical gauze pads.
441763|NCT00576420|E3|Reported Event|Fibrin Sealant All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time
FS VH S/D 500 s-apr, 120 seconds polymerization time"
441764|NCT00576420|E2|Reported Event|Fibrin Sealant - 120 Seconds|FS VH S/D 500 s-apr, 120 seconds polymerization time
441765|NCT00576420|E1|Reported Event|Fibrin Sealant - 60 Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time
441766|NCT00581867|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and insulin first.
441767|NCT00581867|P2|Participant Flow|Intranasal Insulin First, Then Placebo|Participants in this group were randomized to receive Intranasal Insulin at the first fMRI visit and then received Placebo at the second fMRI visit.
441768|NCT00581867|P1|Participant Flow|Placebo First, Then Intranasal Insulin|Participants in this group were randomized to receive placebo at the first fMRI visit and then received Intranasal Insulin at the second fMRI visit.
441769|NCT00581867|O2|Outcome|Placebo|
441770|NCT00581867|O1|Outcome|Intranasal Insulin Aspart|
441771|NCT00581867|O2|Outcome|Placebo|
441772|NCT00581867|O1|Outcome|Intranasal Insulin Aspart|
441773|NCT00581867|E2|Reported Event|Placebo|Placebo was administered in either first or second intervention period.
441774|NCT00581867|E1|Reported Event|Intranasal Insulin Aspart|Intranasal Insulin was administered in either first or second intervention period.
441775|NCT00581919|B1|Baseline|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
441776|NCT00581919|P1|Participant Flow|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
441777|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
441778|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
441779|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bort, Dex, and Dox with ALCAR: Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
441780|NCT00581919|E1|Reported Event|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
441781|NCT00581945|B3|Baseline|Total|Total of all reporting groups
441782|NCT00581945|B2|Baseline|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
441783|NCT00581945|B1|Baseline|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
441784|NCT00581945|P2|Participant Flow|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
441785|NCT00581945|P1|Participant Flow|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
441786|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
441787|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
441788|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
441789|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
441790|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
441791|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
441792|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
441793|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
441794|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
441795|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
441796|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
441797|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
441798|NCT00581945|E2|Reported Event|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
441799|NCT00581945|E1|Reported Event|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
441800|NCT00581971|B1|Baseline|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
441801|NCT00581971|P1|Participant Flow|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|Patients with locally advanced head and neck cancer will be treated with weekly carboplatin, paclitaxel, and concurrent radiotherapy. Radiotherapy will be delivered at 1.8 Gy every day, to a maximum dose of 70.2 Gy. Carboplatin will be dosed at AUC=2.0, while paclitaxel will be dosed at 30mg/m2. Celecoxib will be delivered at 400mg twice daily, starting 1 week prior to the onset of radiotherapy to establish constant blood levels.
441802|NCT00581971|O1|Outcome|Recurrence|
441803|NCT00581971|O1|Outcome|Acute Toxicity|Participants that experienced Grade 3 or higher toxicity factors.
441804|NCT00581971|E1|Reported Event|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
441805|NCT00582010|B3|Baseline|Total|Total of all reporting groups
441806|NCT00582010|B2|Baseline|Placebo (Nitrogen Gas)|80 ppm was administered by inhalation for the duration of surgery
441807|NCT00582010|B1|Baseline|Inhaled Nitric Oxide|80 ppm was administered by inhalation for the duration of surgery
441808|NCT00582010|P2|Participant Flow|2. Placebo|"Placebo (nitrogen)
nitrogen gas : inhaled"
441809|NCT00582010|P1|Participant Flow|1. Experimental|"iNO administration
inhaled nitric oxide : inhaled 80ppm for duration of surgery."
441810|NCT00582010|O2|Outcome|Placebo|
441811|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
441812|NCT00582010|O2|Outcome|Placebo|
441813|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
441814|NCT00582010|O2|Outcome|Placebo|
441815|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
441816|NCT00582010|O2|Outcome|Placebo|
441817|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
441818|NCT00582010|O2|Outcome|Placebo|
441819|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
441820|NCT00582010|O2|Outcome|Placebo|
441821|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
441822|NCT00582010|O2|Outcome|Placebo|
441823|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
441824|NCT00582010|O2|Outcome|Placebo|
441825|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
441826|NCT00582010|O2|Outcome|Placebo|
441827|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
441828|NCT00582010|E2|Reported Event|2. Placebo|"Placebo (nitrogen)
nitrogen gas : inhaled"
441988|NCT00589784|B1|Baseline|Aggressive Memingioma|Patients with Aggressive Memingioma
441829|NCT00582010|E1|Reported Event|1. Experimental|"iNO administration
inhaled nitric oxide : inhaled 80ppm for duration of surgery."
441830|NCT00582036|B3|Baseline|Total|Total of all reporting groups
441831|NCT00582036|B2|Baseline|Arm 2|"Baseline IV Insulin infusion begins with:
>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime
Sliding Scale IV Insulin adjustments based on:
>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
441832|NCT00582036|B1|Baseline|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
441833|NCT00582036|P2|Participant Flow|Arm 2|"Baseline IV Insulin infusion begins with:
>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime
Sliding Scale IV Insulin adjustments based on:
>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
441834|NCT00582036|P1|Participant Flow|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
441835|NCT00582036|O2|Outcome|Arm 2|"Baseline IV Insulin infusion begins with:
>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime
Sliding Scale IV Insulin adjustments based on:
>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
441836|NCT00582036|O1|Outcome|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
441837|NCT00582036|E2|Reported Event|Arm 2|"Baseline IV Insulin infusion begins with:
>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime
Sliding Scale IV Insulin adjustments based on:
>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
441838|NCT00582036|E1|Reported Event|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
441839|NCT00582075|B1|Baseline|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
441840|NCT00582075|P1|Participant Flow|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
441841|NCT00582075|O1|Outcome|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
441842|NCT00582075|O1|Outcome|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
441843|NCT00582075|E1|Reported Event|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
441844|NCT00582114|B3|Baseline|Total|Total of all reporting groups
441845|NCT00582114|B2|Baseline|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
441846|NCT00582114|B1|Baseline|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
441847|NCT00582114|P2|Participant Flow|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
441848|NCT00582114|P1|Participant Flow|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
441849|NCT00582114|O2|Outcome|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
441850|NCT00582114|O1|Outcome|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
441989|NCT00589784|P2|Participant Flow|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
441851|NCT00582114|O2|Outcome|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
441852|NCT00582114|O1|Outcome|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
441853|NCT00582114|E2|Reported Event|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
441854|NCT00582114|E1|Reported Event|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
441855|NCT00582205|B1|Baseline|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy
Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
441856|NCT00582205|P1|Participant Flow|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy
Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
441857|NCT00582205|O1|Outcome|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy
Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
441858|NCT00582205|O1|Outcome|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy
Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
441859|NCT00582205|E1|Reported Event|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy
Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
441860|NCT00582309|B4|Baseline|Total|Total of all reporting groups
441861|NCT00582309|B3|Baseline|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
441862|NCT00582309|B2|Baseline|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
441863|NCT00582309|B1|Baseline|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
441864|NCT00582309|P3|Participant Flow|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
441865|NCT00582309|P2|Participant Flow|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
441866|NCT00582309|P1|Participant Flow|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
441867|NCT00582309|O3|Outcome|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
441868|NCT00582309|O2|Outcome|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
441869|NCT00582309|O1|Outcome|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
441870|NCT00582309|E3|Reported Event|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
441871|NCT00582309|E2|Reported Event|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
441872|NCT00582309|E1|Reported Event|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
441873|NCT00582361|B3|Baseline|Total|Total of all reporting groups
441874|NCT00582361|B2|Baseline|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
441875|NCT00582361|B1|Baseline|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
441990|NCT00589784|P1|Participant Flow|Aggressive Memingioma|Patients with Aggressive Memingioma
441876|NCT00582361|P2|Participant Flow|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
441877|NCT00582361|P1|Participant Flow|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
441878|NCT00582361|O2|Outcome|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
441879|NCT00582361|O1|Outcome|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
441880|NCT00582361|O2|Outcome|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
441881|NCT00582361|O1|Outcome|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
441882|NCT00582361|E2|Reported Event|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
441883|NCT00582361|E1|Reported Event|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
441884|NCT00582400|B1|Baseline|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
441885|NCT00582400|P1|Participant Flow|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
441886|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
441887|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
441888|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
441889|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
441890|NCT00582400|E1|Reported Event|Arsenic Trioxide (Trisenox)|"arsenic trioxide: Trisenox will be diluted with 100 to 250 mL 0.9% Sodium Chloride injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. The Trisenox ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Trisenox is not to be mixed with other medications.
The loading dose of Trisenox will be administered intravenously over 2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. The drug will be administered IV through a functional peripheral or central venous line. Trisenox is not a vesicant, and may be a mild irritant if administered into the skin without dilution."
441891|NCT00582426|B3|Baseline|Total|Total of all reporting groups
441892|NCT00582426|B2|Baseline|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441893|NCT00582426|B1|Baseline|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441894|NCT00582426|P2|Participant Flow|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441895|NCT00582426|P1|Participant Flow|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441896|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441897|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441898|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441899|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441900|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441901|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441902|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441903|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441904|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441905|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441906|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441907|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441908|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441909|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441910|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441911|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441912|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441913|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441914|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441915|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441916|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
441917|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
441918|NCT00582426|E2|Reported Event|Standard Treatment|
441919|NCT00582426|E1|Reported Event|Octreotide LAR|
441920|NCT00589550|B1|Baseline|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis"
441921|NCT00589550|P1|Participant Flow|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis"
441922|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis"
441923|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis"
441924|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis"
441925|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis"
441926|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis"
441927|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis"
441991|NCT00589784|O2|Outcome|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
441992|NCT00589784|O1|Outcome|Aggressive Memingioma|Patients with Aggressive Memingioma
441993|NCT00589784|E1|Reported Event|All Patients|All patients treated with Sunitinib (SU011248)
441994|NCT00593320|B3|Baseline|Total|Total of all reporting groups
441995|NCT00593320|B2|Baseline|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
441928|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis"
441929|NCT00589550|E1|Reported Event|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Sorafenib
gene expression analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
immunoenzyme technique
laboratory biomarker analysis"
441930|NCT00589563|B1|Baseline|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441931|NCT00589563|P1|Participant Flow|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441932|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441933|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441934|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441935|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441936|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441937|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441938|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441939|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441940|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441941|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441942|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441943|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441944|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441945|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
441946|NCT00589563|E1|Reported Event|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done. One patient did not have adverse event data collected.
441947|NCT00589602|B1|Baseline|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.
Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'
peripheral blood lymphocyte therapy: T-cell depletion
cyclophosphamide: T-cell depletion
tacrolimus: T-cell depletion
allogeneic hematopoietic stem cell transplantation: T-cell depletion
peripheral blood stem cell transplantation: T-cell depletion
total-body irradiation: T-cell depletion"
441948|NCT00589602|P1|Participant Flow|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.
Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'
peripheral blood lymphocyte therapy: T-cell depletion
cyclophosphamide: T-cell depletion
tacrolimus: T-cell depletion
allogeneic hematopoietic stem cell transplantation: T-cell depletion
peripheral blood stem cell transplantation: T-cell depletion
total-body irradiation: T-cell depletion"
441949|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.
cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day –5 and Day –4
tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days"
441950|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.
cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day –5 and Day –4
tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days"
441996|NCT00593320|B1|Baseline|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
441997|NCT00593320|P2|Participant Flow|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
441998|NCT00593320|P1|Participant Flow|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
441951|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.
cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day –5 and Day –4
tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days"
441952|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of matched unrelated donor allogeneic bone marrow transplant (MUD allo BMT) and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.
Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; allogeneic hematopoietic stem cell transplantation;
peripheral blood lymphocyte therapy: T-cell depletion
cyclophosphamide: T-cell depletion
tacrolimus: T-cell depletion
allogeneic hematopoietic stem cell transplantation: T-cell depletion
peripheral blood stem cell transplantation: T-cell depletion
total-body irradiation: T-cell depletion"
441953|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.
Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'
peripheral blood lymphocyte therapy: T-cell depletion
cyclophosphamide: T-cell depletion
tacrolimus: T-cell depletion
allogeneic hematopoietic stem cell transplantation: T-cell depletion
peripheral blood stem cell transplantation: T-cell depletion
total-body irradiation: T-cell depletion"
441954|NCT00589602|E1|Reported Event|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion
cyclophosphamide: T-cell depletion
tacrolimus: T-cell depletion
allogeneic hematopoietic stem cell transplantation: T-cell depletion
peripheral blood stem cell transplantation: T-cell depletion
total-body irradiation: T-cell depletion"
441955|NCT00589628|B3|Baseline|Total|Total of all reporting groups
441956|NCT00589628|B2|Baseline|10 mg/kg of Infliximab|10mg/kg/dose of infliximab Iv at 4 week intervals
441957|NCT00589628|B1|Baseline|5 mg/kg of Infliximab|5mg/kg/does of infliximab IV at 4 week intervals
441958|NCT00589628|P2|Participant Flow|Infliximab 10 mg/kg|10mg/kg/dose of infliximab Iv at 4 week intervals
441959|NCT00589628|P1|Participant Flow|Infliximab 5 mg/kg|5mg/kg/does of infliximab IV at 4 week intervals
441960|NCT00589628|O2|Outcome|Infliximab 10mg/kg|10mg/kg/dose of infliximab Iv at 4 week intervals
441961|NCT00589628|O1|Outcome|Infliximab 5mg/kg|5mg/kg/does of infliximab IV at 4 week intervals
441962|NCT00589628|E2|Reported Event|10 mg/kg of Infliximab|10mg/kg/dose of infliximab Iv at 4 week intervals
441963|NCT00589628|E1|Reported Event|5 mg/kg of Infliximab|5mg/kg/does of infliximab IV at 4 week intervals
441964|NCT00589667|B1|Baseline|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
441965|NCT00589667|P1|Participant Flow|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
441966|NCT00589667|O1|Outcome|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
441967|NCT00589667|O1|Outcome|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
441968|NCT00589667|E1|Reported Event|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
441969|NCT00589693|B3|Baseline|Total|Total of all reporting groups
441970|NCT00589693|B2|Baseline|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
441971|NCT00589693|B1|Baseline|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
441972|NCT00589693|P2|Participant Flow|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
441973|NCT00589693|P1|Participant Flow|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
441974|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
441975|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
441976|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
441977|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
441978|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
441979|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
441980|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
441981|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
441982|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
441983|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
441984|NCT00589693|E2|Reported Event|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
441985|NCT00589693|E1|Reported Event|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
441986|NCT00589784|B3|Baseline|Total|Total of all reporting groups
441987|NCT00589784|B2|Baseline|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
441999|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
442000|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
442001|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
442002|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
442003|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
442004|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
442005|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
442006|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
442007|NCT00593320|E2|Reported Event|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
442008|NCT00593320|E1|Reported Event|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
442009|NCT00593333|B3|Baseline|Total|Total of all reporting groups
442010|NCT00593333|B2|Baseline|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
442011|NCT00593333|B1|Baseline|Standard Treatment|Pirformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail or an Antegrade Femoral Nail.
442012|NCT00593333|P2|Participant Flow|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
442013|NCT00593333|P1|Participant Flow|Standard Treatment|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
442014|NCT00593333|O2|Outcome|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
442015|NCT00593333|O1|Outcome|Standard Treatment|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
442016|NCT00593333|E2|Reported Event|Group B|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
442017|NCT00593333|E1|Reported Event|Group A|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
442018|NCT00593346|B1|Baseline|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442019|NCT00593346|P1|Participant Flow|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442020|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442021|NCT00593346|O1|Outcome|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442022|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442023|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442024|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442025|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442026|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442027|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442028|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442029|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442030|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442031|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442032|NCT00593346|E1|Reported Event|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
442033|NCT00593372|B3|Baseline|Total|Total of all reporting groups
442034|NCT00593372|B2|Baseline|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
442035|NCT00593372|B1|Baseline|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
442036|NCT00593372|P2|Participant Flow|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
442037|NCT00593372|P1|Participant Flow|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
442038|NCT00593372|O2|Outcome|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
442039|NCT00593372|O1|Outcome|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
442040|NCT00593372|E2|Reported Event|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
442041|NCT00593372|E1|Reported Event|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
442042|NCT00593450|B5|Baseline|Total|Total of all reporting groups
442043|NCT00593450|B4|Baseline|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442044|NCT00593450|B3|Baseline|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442045|NCT00593450|B2|Baseline|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442046|NCT00593450|B1|Baseline|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442047|NCT00593450|P4|Participant Flow|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442048|NCT00593450|P3|Participant Flow|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442049|NCT00593450|P2|Participant Flow|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442050|NCT00593450|P1|Participant Flow|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442051|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442052|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442053|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442054|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442055|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442056|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442057|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442058|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442059|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442060|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442061|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442062|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442063|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442775|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
442776|NCT00594425|O3|Outcome|Vehicle PDT|
442064|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442065|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442066|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442067|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442068|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442069|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442070|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442071|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442072|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442073|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442074|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442075|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442076|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442077|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442078|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442079|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442080|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442081|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442082|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442083|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442084|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442085|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442086|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442087|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442088|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442089|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442090|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442091|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442092|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442093|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442094|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442095|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442096|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442097|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442098|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442249|NCT00593736|P4|Participant Flow|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442099|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442100|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442101|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442102|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442103|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442104|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442105|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442106|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442107|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442108|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442109|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442110|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442111|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442112|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442113|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442114|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442115|NCT00593450|E4|Reported Event|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442116|NCT00593450|E3|Reported Event|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
442117|NCT00593450|E2|Reported Event|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
442118|NCT00593450|E1|Reported Event|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
442119|NCT00593606|B1|Baseline|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442120|NCT00593606|P1|Participant Flow|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442121|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442122|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442123|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442124|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442125|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442126|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442127|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442128|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442129|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442130|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442131|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442132|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442133|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442134|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442135|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442136|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442137|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442138|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442139|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442140|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442141|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442142|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442143|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442144|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442145|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442146|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442147|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442148|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442149|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442150|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442151|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442152|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442153|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442154|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442155|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442156|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442157|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442158|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442159|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442160|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442161|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442162|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442163|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442164|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442777|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
442165|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442166|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442167|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442168|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442169|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442170|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442171|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442172|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442173|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442174|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442175|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442176|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442177|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442178|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442179|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442180|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442181|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442182|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442183|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442184|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442185|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442186|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442187|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442188|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442189|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442190|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442191|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442192|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442193|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442194|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442195|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442196|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442778|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
442197|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442198|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442199|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442200|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442201|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442202|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442203|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442204|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442205|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442206|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442207|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442208|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442209|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442210|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442211|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442212|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442213|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442214|NCT00593606|E1|Reported Event|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
442215|NCT00593645|B1|Baseline|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442216|NCT00593645|P1|Participant Flow|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442217|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442218|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442219|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442220|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442250|NCT00593736|P3|Participant Flow|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442251|NCT00593736|P2|Participant Flow|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442252|NCT00593736|P1|Participant Flow|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442221|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442222|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442223|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442224|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442225|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442226|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442227|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442228|NCT00593645|E1|Reported Event|Arm 1|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
442229|NCT00593684|B3|Baseline|Total|Total of all reporting groups
442230|NCT00593684|B2|Baseline|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
442231|NCT00593684|B1|Baseline|Algidex Patch|
442232|NCT00593684|P2|Participant Flow|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
442233|NCT00593684|P1|Participant Flow|Algidex Patch|
442234|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
442235|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
442236|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
442237|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
442238|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
442239|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
442240|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
442241|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
442242|NCT00593684|E2|Reported Event|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
442243|NCT00593684|E1|Reported Event|Algidex Patch|
442244|NCT00593736|B5|Baseline|Total|Total of all reporting groups
442245|NCT00593736|B4|Baseline|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442246|NCT00593736|B3|Baseline|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442247|NCT00593736|B2|Baseline|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442248|NCT00593736|B1|Baseline|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442253|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442254|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442255|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442256|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442257|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442258|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442259|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442260|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442261|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442262|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442263|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442264|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442265|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442266|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442267|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442268|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442269|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442270|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442271|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442272|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442273|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442274|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442275|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442276|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442277|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442278|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442279|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442280|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442281|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442282|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442283|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442284|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442285|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442286|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442287|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442288|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442289|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442290|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442291|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442292|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442293|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442294|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442295|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442296|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442297|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442298|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442299|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442300|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442301|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442302|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442303|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442304|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442305|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442306|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442307|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442308|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442309|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442310|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442311|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442312|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442313|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442314|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442315|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442316|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442317|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442318|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442319|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442320|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442321|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442322|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442323|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442324|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442325|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442326|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442327|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442328|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442329|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442330|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442331|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442332|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442333|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442334|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442335|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442336|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442337|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442338|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442339|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442340|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442341|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442342|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442343|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442344|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442345|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442346|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442347|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442348|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442349|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442350|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442351|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442352|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442353|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442354|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442355|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442356|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442357|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442358|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442359|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442360|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442361|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442362|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442363|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442364|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442365|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442366|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442367|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442368|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442369|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442370|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442371|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442372|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442373|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442374|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442375|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442376|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442377|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442378|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442379|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442380|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442381|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442382|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442383|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442384|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442385|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442386|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442387|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442388|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442389|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442390|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442391|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442392|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442393|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442394|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442395|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442396|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442397|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442398|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442399|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442400|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442401|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442402|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442403|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442404|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442405|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442406|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442407|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442408|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442409|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442410|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442411|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442412|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442413|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442414|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442415|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442416|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442417|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442418|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442419|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442420|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442421|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442422|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442423|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442424|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442425|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442426|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442427|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442428|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442429|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442430|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442431|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442432|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442433|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442434|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442435|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442436|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442437|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442438|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442439|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442440|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442441|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442442|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442443|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442444|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442445|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442446|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442447|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442448|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442449|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442450|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442451|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442452|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442453|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442454|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442455|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442456|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442457|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442458|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442459|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442460|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442461|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442462|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442463|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442464|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442465|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442466|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442467|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442468|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442469|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442470|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442471|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442472|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442473|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442474|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442475|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442476|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442477|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442478|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442479|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442480|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442481|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442482|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442483|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442484|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442485|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442486|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442487|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442488|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442489|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442490|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442491|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442492|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442493|NCT00593736|E4|Reported Event|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
442494|NCT00593736|E3|Reported Event|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
442495|NCT00593736|E2|Reported Event|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
442496|NCT00593736|E1|Reported Event|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
442497|NCT00593814|B3|Baseline|Total|Total of all reporting groups
442498|NCT00593814|B2|Baseline|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
442499|NCT00593814|B1|Baseline|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
442500|NCT00593814|P2|Participant Flow|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
442501|NCT00593814|P1|Participant Flow|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
442502|NCT00593814|O2|Outcome|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
442503|NCT00593814|O1|Outcome|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
442504|NCT00593814|E2|Reported Event|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
442505|NCT00593814|E1|Reported Event|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
442506|NCT00593827|B3|Baseline|Total|Total of all reporting groups
442507|NCT00593827|B2|Baseline|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442508|NCT00593827|B1|Baseline|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442509|NCT00593827|P2|Participant Flow|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442510|NCT00593827|P1|Participant Flow|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442511|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442512|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442513|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442514|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442515|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442516|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442517|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442518|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442519|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442520|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442521|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442522|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442523|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442524|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442525|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442526|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442527|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442528|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442529|NCT00593827|E2|Reported Event|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
442530|NCT00593827|E1|Reported Event|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
442554|NCT00593918|O1|Outcome|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
442637|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
442531|NCT00593840|B1|Baseline|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
442532|NCT00593840|P1|Participant Flow|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
442533|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions"
442534|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions"
442535|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions"
442536|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions"
442537|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions"
442538|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions"
442539|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions
CTV2 = 60 Gy in 33 fractions
CTV3 = 56 Gy in 33 fractions
CTV3 Proto = 56 Gy in 33 fractions"
442540|NCT00593840|E1|Reported Event|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
442541|NCT00593866|B1|Baseline|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
442542|NCT00593866|P1|Participant Flow|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
442543|NCT00593866|O1|Outcome|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
442544|NCT00593866|O1|Outcome|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
442545|NCT00593866|E1|Reported Event|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
442546|NCT00593918|B3|Baseline|Total|Total of all reporting groups
442547|NCT00593918|B2|Baseline|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
442548|NCT00593918|B1|Baseline|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
442549|NCT00593918|P2|Participant Flow|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
442550|NCT00593918|P1|Participant Flow|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
442551|NCT00593918|O2|Outcome|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
442552|NCT00593918|O1|Outcome|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
442553|NCT00593918|O2|Outcome|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
442779|NCT00594425|O3|Outcome|Vehicle PDT|
442555|NCT00593918|E2|Reported Event|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
442556|NCT00593918|E1|Reported Event|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
442557|NCT00593957|B4|Baseline|Total|Total of all reporting groups
442558|NCT00593957|B3|Baseline|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442559|NCT00593957|B2|Baseline|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442560|NCT00593957|B1|Baseline|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442561|NCT00593957|P3|Participant Flow|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442562|NCT00593957|P2|Participant Flow|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442563|NCT00593957|P1|Participant Flow|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442564|NCT00593957|O2|Outcome|Total Sample SSI Mean Score at 6 Months|Study Sample Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
442565|NCT00593957|O1|Outcome|Total Sample SSI Mean Score at Baseline|Study Sample Screen for Social Interaction (SSI) mean core at baseline.
442566|NCT00593957|O6|Outcome|DM3 (5.0 mg/kg/Day) SSI 6 Months|DM3(5.0) mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
442567|NCT00593957|O5|Outcome|DM2 (2.5 mg/kg/Day) SSI 6 Months|DM2( 2.5 mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
442568|NCT00593957|O4|Outcome|DM1( 0.25 mg/kg /Day) SSI 6 Months|DM1( 0.25 mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
442569|NCT00593957|O3|Outcome|DM3 (5mg/kg/Day) SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 5mg/kg/day treatment arm.
442570|NCT00593957|O2|Outcome|DM2 (2.5 mg/kg/Day)SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 2.5 mg/kg/day treatment arm.
442571|NCT00593957|O1|Outcome|DM1( 0.25 mg/kg /Day) SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 0.25 mg/kg per day treatment arm.
442572|NCT00593957|O3|Outcome|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442573|NCT00593957|O2|Outcome|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442574|NCT00593957|O1|Outcome|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442575|NCT00593957|O6|Outcome|DM3 EEG Spike Counts at 6 Months|DM3 group received Dextromethorphan 5mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike counts at 6 months.
442576|NCT00593957|O5|Outcome|DM2 EEG Spike Counts at 6 Months|DM2 group participants received Dextromethorphan 2.5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. DM2 EEG spike counts at 6 months.
442577|NCT00593957|O4|Outcome|DM1 EEG Spike Count at 6 Months|DM1 group received Dextromethorphan 0.25 mg/kg per day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike count for DM1 group measured at 6 months.
442578|NCT00593957|O3|Outcome|DM3 EEG Spike Counts at Baseline|"DM3 group received Dextromethorphan 5mg/kg/day.
The drug is given in two divided doses 12 hours apart for 6 months. EEG spike counts at baseline."
442579|NCT00593957|O2|Outcome|DM2 EEG Spike Counts at Baseline|DM2 group participants received Dextromethorphan 2.5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. DM2 EEG spike counts at baseline.
442580|NCT00593957|O1|Outcome|Dextromethorphan (DM)1 EEG Spike Counts at Baseline|Dextromethorphan(DM)I group received Dextromethorphan 0.25 mg/kg per day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike count for DM1 group measured at baseline.
442581|NCT00593957|E3|Reported Event|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442582|NCT00593957|E2|Reported Event|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442583|NCT00593957|E1|Reported Event|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day
Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
442584|NCT00594022|B3|Baseline|Total|Total of all reporting groups
442585|NCT00594022|B2|Baseline|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).
Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
442586|NCT00594022|B1|Baseline|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT (multiple sleep latency test) >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).
Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
442587|NCT00594022|P2|Participant Flow|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).
Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
442588|NCT00594022|P1|Participant Flow|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).
Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
442589|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).
Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
442590|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).
Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
442591|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).
Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
442612|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
442636|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
442592|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).
Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
442593|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).
Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
442594|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).
Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
442595|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).
Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
442596|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).
Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
442597|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).
Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
442598|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).
Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
442599|NCT00594022|E2|Reported Event|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).
Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
442600|NCT00594022|E1|Reported Event|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).
Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
442601|NCT00594035|B3|Baseline|Total|Total of all reporting groups
442602|NCT00594035|B2|Baseline|Standard of Care|Subjects who receive standard or care meathods of dural sealing
442603|NCT00594035|B1|Baseline|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
442604|NCT00594035|P2|Participant Flow|Standard of Care|Subjects who receive standard or care meathods of dural sealing
442605|NCT00594035|P1|Participant Flow|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
442606|NCT00594035|O2|Outcome|Standard of Care|Subjects who receive standard or care meathods of dural sealing
442607|NCT00594035|O1|Outcome|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
442608|NCT00594035|E2|Reported Event|Standard of Care|Subjects who receive standard or care meathods of dural sealing
442609|NCT00594035|E1|Reported Event|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
442610|NCT00594100|B1|Baseline|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
442611|NCT00594100|P1|Participant Flow|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
442720|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
442613|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
442614|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
442615|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
442616|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
442617|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
442618|NCT00594100|E1|Reported Event|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
442619|NCT00594165|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442620|NCT00594165|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442621|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442622|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442623|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442624|NCT00594165|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442625|NCT00594178|B1|Baseline|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
442626|NCT00594178|P1|Participant Flow|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
442627|NCT00594178|O1|Outcome|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
442628|NCT00594178|O1|Outcome|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
442629|NCT00594178|E1|Reported Event|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
442630|NCT00594204|B3|Baseline|Total|Total of all reporting groups
442631|NCT00594204|B2|Baseline|Placebo|matching placebo following the same treatment schema as the varenicline group
442632|NCT00594204|B1|Baseline|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
442633|NCT00594204|P2|Participant Flow|Placebo|matching placebo following the same treatment schema as the varenicline group
442634|NCT00594204|P1|Participant Flow|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
442635|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
442721|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
442722|NCT00594425|O3|Outcome|Vehicle PDT|
442638|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
442639|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
442640|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
442641|NCT00594204|E2|Reported Event|Placebo|matching placebo following the same treatment schema as the varenicline group
442642|NCT00594204|E1|Reported Event|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
442643|NCT00594230|B3|Baseline|Total|Total of all reporting groups
442644|NCT00594230|B2|Baseline|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
442645|NCT00594230|B1|Baseline|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
442646|NCT00594230|P2|Participant Flow|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
442647|NCT00594230|P1|Participant Flow|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
442648|NCT00594230|O2|Outcome|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
442649|NCT00594230|O1|Outcome|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
442650|NCT00594230|E2|Reported Event|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
442651|NCT00594230|E1|Reported Event|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
442652|NCT00594256|B1|Baseline|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
442653|NCT00594256|P1|Participant Flow|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
442654|NCT00594256|O1|Outcome|Sodium Oxybate|
442655|NCT00594256|O1|Outcome|Sodium Oxybate|
442656|NCT00594256|O1|Outcome|Sodiumn Oxybate|
442657|NCT00594256|O1|Outcome|Sodium Oxybate|
442658|NCT00594256|O1|Outcome|Sodium Oxybate|
442659|NCT00594256|E1|Reported Event|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
442660|NCT00594308|B1|Baseline|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
442661|NCT00594308|P1|Participant Flow|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
442662|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
442663|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
442723|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
442664|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
442665|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
442666|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
442667|NCT00594308|E1|Reported Event|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
442668|NCT00594386|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442669|NCT00594386|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442670|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442671|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442672|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442673|NCT00594386|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
442674|NCT00594399|B3|Baseline|Total|Total of all reporting groups
442675|NCT00594399|B2|Baseline|Arm 2|Usual care from primary, womens or geriatric clinics
442676|NCT00594399|B1|Baseline|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442677|NCT00594399|P3|Participant Flow|Arm 3, Physical Activity Counseling, Reduced Dose|Upon rerandomization, individuals in this group continued to receive monthly physical activity counseling through 6 months which was then reduced to every other month during months 6-12.
442678|NCT00594399|P2|Participant Flow|Arm 2, Usual Care|Usual care from primary, womens or geriatric clinics
442679|NCT00594399|P1|Participant Flow|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442680|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
442681|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442682|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
442683|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442684|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
442685|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442686|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
442724|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
442725|NCT00594425|O3|Outcome|Vehicle PDT|
442726|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
442727|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
442728|NCT00594425|O3|Outcome|Vehicle PDT|
442729|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
442730|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
442731|NCT00594425|O3|Outcome|Vehicle PDT|
442687|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442688|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
442689|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442690|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
442691|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442692|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
442693|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442694|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
442695|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442696|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
442697|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442698|NCT00594399|E2|Reported Event|Arm 2|Usual care from primary, womens or geriatric clinics
442699|NCT00594399|E1|Reported Event|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
442700|NCT00594425|B4|Baseline|Total|Total of all reporting groups
442701|NCT00594425|B3|Baseline|Vehicle PDT|
442702|NCT00594425|B2|Baseline|80 mg/g MAL PDT|
442703|NCT00594425|B1|Baseline|40 mg/g MAL PDT|
442704|NCT00594425|P3|Participant Flow|Vehicle PDT|
442705|NCT00594425|P2|Participant Flow|80 mg/g MAL PDT|
442706|NCT00594425|P1|Participant Flow|40 mg/g MAL PDT|
442707|NCT00594425|O3|Outcome|Vehicle PDT|
442708|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
442709|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
442710|NCT00594425|O3|Outcome|Vehicle PDT|
442711|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
442712|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
442713|NCT00594425|O3|Outcome|Vehicle PDT|
442714|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
442715|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
442716|NCT00594425|O3|Outcome|Vehicle PDT|
442717|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
442718|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
442719|NCT00594425|O3|Outcome|Vehicle PDT|
442815|NCT00594464|B1|Baseline|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
442816|NCT00594464|P1|Participant Flow|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
442817|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
442818|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
442819|NCT00594464|O6|Outcome|Rotigotine 16 mg/24h|
442820|NCT00594464|O5|Outcome|Rotigotine 14 mg/24h|
442821|NCT00594464|O4|Outcome|Rotigotine 12 mg/24h|
442822|NCT00594464|O3|Outcome|Rotigotine 8 mg/24h|
442823|NCT00594464|O2|Outcome|Rotigotine 6mg/24h|
442824|NCT00594464|O1|Outcome|Rotigotine 2 mg/24h|
442825|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
442826|NCT00594464|E1|Reported Event|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
442827|NCT00594516|B1|Baseline|Tapentadol|Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
442828|NCT00594516|P3|Participant Flow|Tapentadol ER to IR|Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second intervention period of double-blind phase
442829|NCT00594516|P2|Participant Flow|Tapentadol IR to ER|Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second intervention period of double-blind phase
442830|NCT00594516|P1|Participant Flow|Tapentadol|Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
442831|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
442832|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
442833|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
442834|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
442835|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
442836|NCT00594516|E1|Reported Event|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) open-label and the double-blind crossover period.
442837|NCT00594568|B4|Baseline|Total|Total of all reporting groups
442838|NCT00594568|B3|Baseline|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442839|NCT00594568|B2|Baseline|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442840|NCT00594568|B1|Baseline|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442841|NCT00594568|P3|Participant Flow|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442842|NCT00594568|P2|Participant Flow|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442843|NCT00594568|P1|Participant Flow|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442844|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442845|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442846|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442847|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442848|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442849|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442850|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442851|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442852|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442853|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
443364|NCT00585923|P1|Participant Flow|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
442854|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442855|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442856|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442857|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442858|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442859|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442860|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442861|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442862|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442863|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442864|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442865|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442866|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442867|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442868|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442869|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442870|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442871|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442872|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442873|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442874|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442875|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442876|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
443018|NCT00594945|E1|Reported Event|Intranasal Clonazepam 2 mg|
442877|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442878|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442879|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442880|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442881|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442882|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442883|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442884|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442885|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442886|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442887|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442888|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442889|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442890|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442891|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442892|NCT00594568|O1|Outcome|LY450139|Participants received 60 milligram LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442893|NCT00594568|O1|Outcome|LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442894|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442895|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442896|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442897|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442898|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442899|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442900|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442901|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442902|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442903|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442904|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442905|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442906|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442907|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442908|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442909|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442910|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442911|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442912|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442913|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442914|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442915|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442916|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
442917|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442918|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442919|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
443365|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
442920|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442921|NCT00594568|E9|Reported Event|140 mg LY450139- SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
442922|NCT00594568|E8|Reported Event|100 mg LY450139- SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 100 mg LY450139 initial treatment or delayed start or did not enter SFU.
442923|NCT00594568|E7|Reported Event|Placebo- Safety FU Period (SFU)|For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.
442924|NCT00594568|E6|Reported Event|140 mg LY450139 - DO|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442925|NCT00594568|E5|Reported Event|100 mg LY450139 - DO|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
442926|NCT00594568|E4|Reported Event|Placebo - Delayed Start Period (DO)|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
442927|NCT00594568|E3|Reported Event|140 mg LY450139 - NT|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
442928|NCT00594568|E2|Reported Event|100 mg LY450139 - NT|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
442929|NCT00594568|E1|Reported Event|Placebo - Initial Treatment Period (NT)|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.
442930|NCT00594646|B1|Baseline|Group 1|TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
442931|NCT00594646|P1|Participant Flow|Group 1|Men or women, 18 years of age or older, who present within 72 hours of a potential non-occupational exposure to HIV-1.
442932|NCT00594646|O1|Outcome|Group 1|TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
442933|NCT00594646|O1|Outcome|Group 1|TDF 300mg + FTC 200mg (TDF/FTC) once daily + raltegravir 400mg twice daily
442934|NCT00594646|E1|Reported Event|Group 1|TDF 300mg and FTC 200mg (TDF/FTC) once daily + raltegravir (400mg) twice daily
442935|NCT00594659|B4|Baseline|Total|Total of all reporting groups
442936|NCT00594659|B3|Baseline|3-tMET|"Therapist delivered motivational enhancement therapy (tMET)
Two session treatment with sessions delivered during weeks 1 and 4.
Two times per week urine drug testing.
Non-contingent incentives delivered for attending each urine testing appointment."
442937|NCT00594659|B2|Baseline|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment
Computer delivered nine MET/CBT sessions during weeks 1-8 and week 12. therapist delivered 3 brief supportive counseling sessions during weeks 1, 4, and 12.
2 times per week urine drug testing.
Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test."
442938|NCT00594659|B1|Baseline|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)
Nine weekly therapy sessions delivered in weeks 1-8 and week 12
2 times per week urine drug testing
Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test."
442939|NCT00594659|P3|Participant Flow|3-tMET|"Motivational enhancement therapy
Motivational enhancement therapy : Two session treatment
2x/wk urine drug testing
non-contingent vouchers"
442940|NCT00594659|P2|Participant Flow|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment
Computerized Psychotherapy : Nine session computer delivered treatment
2 times per week urine drug testing"
442941|NCT00594659|P1|Participant Flow|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)
Psychotherapy : Nine session treatment (wks 1-8 and wk 12)
2x/wk urine drug testing
Contingency Management voucher program"
442942|NCT00594659|O3|Outcome|3-tMET|"Motivational enhancement therapy
Motivational enhancement therapy : Two session treatment"
442943|NCT00594659|O2|Outcome|2-cMET/CBT/CM|"Computerized Cognitive Behavioral treatment
Computerized Psychotherapy : Nine session computer delivered treatment"
442944|NCT00594659|O1|Outcome|1-tMET/CBT/CM|"Therapist delivered cognitive behavioral treatment
Psychotherapy : Nine session treatment"
442945|NCT00594659|O3|Outcome|3-tMET|"Motivational enhancement therapy
Motivational enhancement therapy : Two session treatment"
442946|NCT00594659|O2|Outcome|2-cMET/CBT/CM|"Computerized Cognitive Behavioral treatment
Computerized Psychotherapy : Nine session computer delivered treatment"
442947|NCT00594659|O1|Outcome|1-tMET/CBT/CM|"Therapist delivered cognitive behavioral treatment
Psychotherapy : Nine session treatment"
442948|NCT00594659|E3|Reported Event|3-tMET|"Motivational enhancement therapy
Motivational enhancement therapy : Two session treatment
2x/wk urine drug testing
non-contingent vouchers"
442949|NCT00594659|E2|Reported Event|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment
Computerized Psychotherapy : Nine session computer delivered treatment
2 times per week urine drug testing"
442950|NCT00594659|E1|Reported Event|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)
Psychotherapy : Nine session treatment (wks 1-8 and wk 12)
2x/wk urine drug testing
Contingency Management voucher program"
442951|NCT00594685|B1|Baseline|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442952|NCT00594685|P1|Participant Flow|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
443030|NCT00594958|E2|Reported Event|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
442953|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442954|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442955|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442956|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442957|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442958|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442959|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442960|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442961|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442962|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442963|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442964|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442965|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442966|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442967|NCT00594685|E1|Reported Event|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
442968|NCT00594815|B1|Baseline|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
442969|NCT00594815|P1|Participant Flow|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
442970|NCT00594815|O1|Outcome|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
442971|NCT00594815|O1|Outcome|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
442972|NCT00594815|E1|Reported Event|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|This is a single-armed pilot study designed to evaluate the safety and efficacy of combined immunochemotherapy followed by reduced dose radiation for participants with newly diagnosed PCNSL.
442973|NCT00594854|B3|Baseline|Total|Total of all reporting groups
442974|NCT00594854|B2|Baseline|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
442975|NCT00594854|B1|Baseline|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
442976|NCT00594854|P2|Participant Flow|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
442977|NCT00594854|P1|Participant Flow|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
442978|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
442979|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
442980|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
442981|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
442982|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
442983|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
442984|NCT00594854|E2|Reported Event|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
442985|NCT00594854|E1|Reported Event|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
442986|NCT00594880|B3|Baseline|Total|Total of all reporting groups
442987|NCT00594880|B2|Baseline|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc
Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
442988|NCT00594880|B1|Baseline|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc
Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
456462|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
442989|NCT00594880|P2|Participant Flow|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc
Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
442990|NCT00594880|P1|Participant Flow|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc
Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
442991|NCT00594880|O2|Outcome|90 mcg/Week|Arm 2 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
442992|NCT00594880|O1|Outcome|180 mcg/Week|Arm 1 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
442993|NCT00594880|O2|Outcome|90 mcg/Week|Patients receiving 90 micrograms/week of pegylated interferon alpha-2a
442994|NCT00594880|O1|Outcome|180 mcg/Week|Patients receiving 180 micrograms/week of pegylated interferon alpha-2a
442995|NCT00594880|O2|Outcome|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc
Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
442996|NCT00594880|O1|Outcome|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc
Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
442997|NCT00594880|E2|Reported Event|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc
Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
442998|NCT00594880|E1|Reported Event|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc
Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
442999|NCT00594906|B3|Baseline|Total|Total of all reporting groups
443000|NCT00594906|B2|Baseline|Placebo|"30 participants will receive placebo injection pens.
Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
443001|NCT00594906|B1|Baseline|Injection|"30 participants will receive teriparatide (Forteo) injection pens.
Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
443002|NCT00594906|P2|Participant Flow|Placebo Injection|"30 participants will receive placebo injection pens.
Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
443003|NCT00594906|P1|Participant Flow|Forteo Injection|"30 participants will receive teriparatide (Forteo) injection pens.
Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
443004|NCT00594906|O2|Outcome|Forteo Patients|Patients who recieved Forteo Injections.
443005|NCT00594906|O1|Outcome|Placebo Patients|Patients who recieved Placebo injections.
443006|NCT00594906|E2|Reported Event|Placebo Injection|Patients who were randomized to Placebo
443007|NCT00594906|E1|Reported Event|Forteo Injection|Patients who randomized to the study drug, Forteo
443008|NCT00594945|B4|Baseline|Total|Total of all reporting groups
443009|NCT00594945|B3|Baseline|Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg|
443010|NCT00594945|B2|Baseline|Intranasal Clonazepam 3 mg|
443011|NCT00594945|B1|Baseline|Intranasal Clonazepam 2 mg|
443012|NCT00594945|P3|Participant Flow|Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg|Subjects who were administered 2 mg during Cohort 1 and then 3 mg during Cohort 2
443013|NCT00594945|P2|Participant Flow|Intranasal Clonazepam 3 mg|Treatment administered to subjects during Cohort 2
443014|NCT00594945|P1|Participant Flow|Intranasal Clonazepam 2 mg|Treatment administered to subjects during Cohort 1
443015|NCT00594945|O2|Outcome|Intranasal Clonazepam 3 mg|
443016|NCT00594945|O1|Outcome|Intranasal Clonazepam 2 mg|
443017|NCT00594945|E2|Reported Event|Intranasal Clonazepam 3 mg|
443019|NCT00594958|B4|Baseline|Total|Total of all reporting groups
443020|NCT00594958|B3|Baseline|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
443021|NCT00594958|B2|Baseline|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
443022|NCT00594958|B1|Baseline|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
443023|NCT00594958|P3|Participant Flow|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
443024|NCT00594958|P2|Participant Flow|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
443025|NCT00594958|P1|Participant Flow|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
443026|NCT00594958|O3|Outcome|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
443027|NCT00594958|O2|Outcome|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
443028|NCT00594958|O1|Outcome|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
443029|NCT00594958|E3|Reported Event|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
456463|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
443031|NCT00594958|E1|Reported Event|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
443032|NCT00595075|B3|Baseline|Total|Total of all reporting groups
443033|NCT00595075|B2|Baseline|Placebo in First Crossover Period|Placebo will be given prior to a 2-hour nap
443034|NCT00595075|B1|Baseline|Ramelteon in First Crossover Period|Ramelteon 8 mg will be given prior to a 2-hour nap
443035|NCT00595075|P2|Participant Flow|Placebo in First Crossover Period|Placebo will be given prior to a 2-hour nap
443036|NCT00595075|P1|Participant Flow|Ramelteon in First Crossover Period|Ramelteon 8 mg will be given prior to a 2-hour nap
443037|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
443038|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
443039|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
443040|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
443041|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
443042|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
443043|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
443044|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
443045|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
443046|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
443047|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
443048|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
443049|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
443050|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
443051|NCT00595075|E2|Reported Event|Placebo|Placebo will be given prior to a 2-hour nap
443052|NCT00595075|E1|Reported Event|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
443053|NCT00595088|B1|Baseline|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
443054|NCT00595088|P1|Participant Flow|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
443055|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
443056|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
443057|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
443058|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
443059|NCT00595088|E1|Reported Event|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
443060|NCT00595114|B3|Baseline|Total|Total of all reporting groups
443061|NCT00595114|B2|Baseline|KIA 1|Participants from the KIA trial with severe asthma
443062|NCT00595114|B1|Baseline|MIA 1|Participants from the MIA trial with mild asthma
443063|NCT00595114|P2|Participant Flow|KIA 1|Participants from the KIA trial with severe asthma
443064|NCT00595114|P1|Participant Flow|MIA 1|Participants from the MIA trial with mild asthma
443065|NCT00595114|O2|Outcome|KIA 1|Participants from the KIA trial with severe asthma
443066|NCT00595114|O1|Outcome|MIA 1|Participants from the MIA trial with mild asthma
443067|NCT00595114|E2|Reported Event|KIA 1|Participants from the KIA trial with severe asthma
443068|NCT00595114|E1|Reported Event|MIA 1|Participants from the MIA trial with mild asthma
443069|NCT00595127|B1|Baseline|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
443070|NCT00595127|P1|Participant Flow|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
443071|NCT00595127|O1|Outcome|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
443072|NCT00595127|E1|Reported Event|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
443073|NCT00595153|B4|Baseline|Total|Total of all reporting groups
443074|NCT00595153|B3|Baseline|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids
Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
443075|NCT00595153|B2|Baseline|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study
Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
443076|NCT00595153|B1|Baseline|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
443077|NCT00595153|P3|Participant Flow|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids
Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
443078|NCT00595153|P2|Participant Flow|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study
Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
443079|NCT00595153|P1|Participant Flow|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
443080|NCT00595153|O3|Outcome|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids
Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
443081|NCT00595153|O2|Outcome|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study
Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
443082|NCT00595153|O1|Outcome|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
443083|NCT00595153|E3|Reported Event|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids
Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
443084|NCT00595153|E2|Reported Event|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study
Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
443085|NCT00595153|E1|Reported Event|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
443086|NCT00595270|B4|Baseline|Total|Total of all reporting groups
443087|NCT00595270|B3|Baseline|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
443088|NCT00595270|B2|Baseline|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
443089|NCT00595270|B1|Baseline|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
443090|NCT00595270|P3|Participant Flow|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
443091|NCT00595270|P2|Participant Flow|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
443092|NCT00595270|P1|Participant Flow|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
443093|NCT00595270|O3|Outcome|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
443094|NCT00595270|O2|Outcome|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
443095|NCT00595270|O1|Outcome|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
443096|NCT00595270|E3|Reported Event|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
443097|NCT00595270|E2|Reported Event|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
443098|NCT00595270|E1|Reported Event|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
443099|NCT00595309|B1|Baseline|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
443100|NCT00595309|P1|Participant Flow|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
443101|NCT00595309|O1|Outcome|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
443102|NCT00595309|E1|Reported Event|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
443103|NCT00595335|B3|Baseline|Total|Total of all reporting groups
443104|NCT00595335|B2|Baseline|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
443160|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
443279|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.
Myfortic: Myfortic 720 mg orally twice daily"
443280|NCT00585468|O2|Outcome|Myfortic - Fasting State|Mycophenolate sodium taken separately from food by 2 hours
443105|NCT00595335|B1|Baseline|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
443106|NCT00595335|P2|Participant Flow|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
443107|NCT00595335|P1|Participant Flow|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
443108|NCT00595335|O2|Outcome|Placebo|Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
443109|NCT00595335|O1|Outcome|Rituximab|Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
443110|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
443111|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.
Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
443112|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
443113|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.
Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
443114|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
443115|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.
Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
443116|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
443117|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.
Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
443118|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
443119|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.
Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
443120|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
443121|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
443122|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
443123|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
443124|NCT00595335|E2|Reported Event|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
443281|NCT00585468|O1|Outcome|Myfortic - Fed State|Mycophenolate sodium taken with a meal
443125|NCT00595335|E1|Reported Event|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
443126|NCT00595361|B3|Baseline|Total|Total of all reporting groups
443127|NCT00595361|B2|Baseline|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
443128|NCT00595361|B1|Baseline|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
443129|NCT00595361|P2|Participant Flow|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
443130|NCT00595361|P1|Participant Flow|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
443131|NCT00595361|O2|Outcome|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
443132|NCT00595361|O1|Outcome|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
443133|NCT00595361|O2|Outcome|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
443134|NCT00595361|O1|Outcome|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
456464|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
443135|NCT00595361|O2|Outcome|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
443136|NCT00595361|O1|Outcome|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
443137|NCT00595361|E2|Reported Event|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
443138|NCT00595361|E1|Reported Event|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment
salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
443139|NCT00595413|B5|Baseline|Total|Total of all reporting groups
443140|NCT00595413|B4|Baseline|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
443141|NCT00595413|B3|Baseline|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
443142|NCT00595413|B2|Baseline|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
443143|NCT00595413|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
443144|NCT00595413|P4|Participant Flow|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
443145|NCT00595413|P3|Participant Flow|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
443146|NCT00595413|P2|Participant Flow|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
443147|NCT00595413|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
443148|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
443149|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
443150|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
443151|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
443152|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
443153|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
443154|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
443155|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
443156|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
443157|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
443158|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
443159|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
443161|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
443162|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
443163|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
443164|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
443165|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
443166|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
443167|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
443168|NCT00595413|E4|Reported Event|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
443169|NCT00595413|E3|Reported Event|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
443170|NCT00595413|E2|Reported Event|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
443171|NCT00595413|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
443172|NCT00595465|B4|Baseline|Total|Total of all reporting groups
443173|NCT00595465|B3|Baseline|IC51 Batch IC51/07E/008A|
443174|NCT00595465|B2|Baseline|IC51 Batch IC51/07E/007A|
443175|NCT00595465|B1|Baseline|IC51 Batch IC51/07E/006A|
443176|NCT00595465|P3|Participant Flow|IC51 Batch IC51/07E/008A|
443177|NCT00595465|P2|Participant Flow|IC51 Batch IC51/07E/007A|
443178|NCT00595465|P1|Participant Flow|IC51 Batch IC51/07E/006A|
443179|NCT00595465|O3|Outcome|IC51 Batch IC51/07E/008A|
443180|NCT00595465|O2|Outcome|IC51 Batch IC51/07E/007A|
443181|NCT00595465|O1|Outcome|IC51 Batch IC51/07E/006A|
443182|NCT00595465|E3|Reported Event|IC51 Batch IC51/07E/008A|
443183|NCT00595465|E2|Reported Event|IC51 Batch IC51/07E/007A|
443184|NCT00595465|E1|Reported Event|IC51 Batch IC51/07E/006A|
443185|NCT00595504|B3|Baseline|Total|Total of all reporting groups
443186|NCT00595504|B2|Baseline|Placebo|sugar pill
443187|NCT00595504|B1|Baseline|Ramelteon|
443188|NCT00595504|P2|Participant Flow|Placebo|sugar pill
443189|NCT00595504|P1|Participant Flow|Ramelteon|
443190|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
443191|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
443192|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
443193|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
443194|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
443195|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
443196|NCT00595504|E2|Reported Event|Placebo|sugar pill
443197|NCT00595504|E1|Reported Event|Ramelteon|
443198|NCT00595517|B1|Baseline|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
443199|NCT00595517|P1|Participant Flow|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
443200|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
443201|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
443202|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
443203|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
443204|NCT00595517|E1|Reported Event|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
443205|NCT00595530|B1|Baseline|Protocol for Administering Ketamine to Patients|"This group will receive ketamine
ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.
Dosing Regimen:
All patients will begin the ketamine infusion at 0.05 mg/kg/hour.
4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:
the patient's pain has not improved to an acceptable level (pain score is still ≥5)
side effects remain acceptable
4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour
4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
The maximum dose of ketamine will be limited to 300 mg per 24 hours
The patient may receive ketamine up to 72 hours after initiation."
443227|NCT00595582|P1|Participant Flow|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
443206|NCT00595530|P1|Participant Flow|Procedure for Administering Ketamine to SCDpatients|"This group will receive ketamine
ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.
Dosing Regimen:
All patients will begin the ketamine infusion at 0.05 mg/kg/hour.
4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:
the patient's pain has not improved to an acceptable level (pain score is still ≥5)
side effects remain acceptable
4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour
4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
The maximum dose of ketamine will be limited to 300 mg per 24 hours
The patient may receive ketamine up to 72 hours after initiation."
443207|NCT00595530|O1|Outcome|Ketamine|"This group will receive ketamine
ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.
Dosing Regimen:
All patients will begin the ketamine infusion at 0.05 mg/kg/hour.
4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:
the patient's pain has not improved to an acceptable level (pain score is still ≥5)
side effects remain acceptable
4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour
4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
The maximum dose of ketamine will be limited to 300 mg per 24 hours
The patient may receive ketamine up to 72 hours after initiation."
443289|NCT00585533|P1|Participant Flow|All Participants|All participants enrolled in trial.
443290|NCT00585533|O1|Outcome|All Participants|All participants enrolled in trial.
443291|NCT00585533|O1|Outcome|All Participants|All participants enrolled in trial.
443208|NCT00595530|E1|Reported Event|Ketamine|"This group will receive ketamine
ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.
Dosing Regimen:
All patients will begin the ketamine infusion at 0.05 mg/kg/hour.
4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:
the patient's pain has not improved to an acceptable level (pain score is still ≥5)
side effects remain acceptable
4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour
4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
The maximum dose of ketamine will be limited to 300 mg per 24 hours
The patient may receive ketamine up to 72 hours after initiation."
443209|NCT00595556|B3|Baseline|Total|Total of all reporting groups
443210|NCT00595556|B2|Baseline|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
443211|NCT00595556|B1|Baseline|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
443212|NCT00595556|P2|Participant Flow|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
443213|NCT00595556|P1|Participant Flow|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
443214|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
443215|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
443216|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
443217|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
443218|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
443219|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
443220|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
443221|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
443222|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
443223|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
443224|NCT00595556|E2|Reported Event|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
443225|NCT00595556|E1|Reported Event|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
443226|NCT00595582|B1|Baseline|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
443228|NCT00595582|O1|Outcome|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
443229|NCT00595582|E1|Reported Event|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
443230|NCT00585351|B7|Baseline|Total|Total of all reporting groups
443231|NCT00585351|B6|Baseline|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
443232|NCT00585351|B5|Baseline|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
443292|NCT00585533|E1|Reported Event|All Participants|All participants enrolled in trial.
443442|NCT00586196|O1|Outcome|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
443233|NCT00585351|B4|Baseline|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
443234|NCT00585351|B3|Baseline|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
443235|NCT00585351|B2|Baseline|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
443236|NCT00585351|B1|Baseline|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
443237|NCT00585351|P8|Participant Flow|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
443238|NCT00585351|P7|Participant Flow|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
443239|NCT00585351|P6|Participant Flow|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
443240|NCT00585351|P5|Participant Flow|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
443241|NCT00585351|P4|Participant Flow|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
443242|NCT00585351|P3|Participant Flow|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
443243|NCT00585351|P2|Participant Flow|No Advanced Notification|Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
443244|NCT00585351|P1|Participant Flow|Advanced Notification|Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
443245|NCT00585351|O4|Outcome|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
443246|NCT00585351|O3|Outcome|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
443247|NCT00585351|O2|Outcome|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
446780|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
443248|NCT00585351|O1|Outcome|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
443249|NCT00585351|O2|Outcome|No Advanced Notification|Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
443250|NCT00585351|O1|Outcome|Advanced Notification|Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
443251|NCT00585351|E6|Reported Event|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
443363|NCT00585923|P2|Participant Flow|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
456465|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
443252|NCT00585351|E5|Reported Event|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
443253|NCT00585351|E4|Reported Event|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
443254|NCT00585351|E3|Reported Event|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
443255|NCT00585351|E2|Reported Event|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
443256|NCT00585351|E1|Reported Event|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
443257|NCT00585377|B1|Baseline|Arm 1|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
443258|NCT00585377|P1|Participant Flow|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
443259|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
443260|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
443261|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
443262|NCT00585377|E1|Reported Event|Arm 1|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
443263|NCT00585468|B1|Baseline|Entire Study Population|Includes groups randomized to the Fed State first and to the Fasted State first
443264|NCT00585468|P2|Participant Flow|Fasting State First, Then Fed State|720 mg mycophenolate sodium orally twice daily separated from food by 2 hours for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily with a meal in the second intervention period.
443265|NCT00585468|P1|Participant Flow|Fed State First, Then Fasting State|720 milligrams (mg) mycophenolate sodium orally twice daily with a meal for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily separated by food by 2 hours in the second intervention period.
443266|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.
Myfortic: Myfortic 720 mg orally twice daily"
443267|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.
Myfortic: Myfortic 720 mg orally twice daily"
443268|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.
Myfortic: Myfortic 720 mg orally twice daily"
443269|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.
Myfortic: Myfortic 720 mg orally twice daily"
443270|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.
Myfortic: Myfortic 720 mg orally twice daily"
443271|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.
Myfortic: Myfortic 720 mg orally twice daily"
443272|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.
Myfortic: Myfortic 720 mg orally twice daily"
443273|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.
Myfortic: Myfortic 720 mg orally twice daily"
443274|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.
Myfortic: Myfortic 720 mg orally twice daily"
443275|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.
Myfortic: Myfortic 720 mg orally twice daily"
443276|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.
Myfortic: Myfortic 720 mg orally twice daily"
443277|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.
Myfortic: Myfortic 720 mg orally twice daily"
443278|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.
Myfortic: Myfortic 720 mg orally twice daily"
443886|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443282|NCT00585468|E2|Reported Event|Myfortic - Fasting State|Mycophenolate sodium taken separately from food by 2 hours
443283|NCT00585468|E1|Reported Event|Myfortic - Fed State|Mycophenolate sodium taken with a meal
443284|NCT00585494|B1|Baseline|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
443285|NCT00585494|P1|Participant Flow|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
443286|NCT00585494|O1|Outcome|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
443287|NCT00585494|E1|Reported Event|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
443288|NCT00585533|B1|Baseline|All Participants|All participants enrolled in trial.
456466|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
443293|NCT00585585|B1|Baseline|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
443294|NCT00585585|P1|Participant Flow|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
443295|NCT00585585|O1|Outcome|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
443296|NCT00585585|E1|Reported Event|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
443297|NCT00585637|B5|Baseline|Total|Total of all reporting groups
443298|NCT00585637|B4|Baseline|4000 IU of Vitamin D|"4000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443299|NCT00585637|B3|Baseline|2000 IU of Vitamin D|"2000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443300|NCT00585637|B2|Baseline|1000 IU of Vitamin D|"1000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443301|NCT00585637|B1|Baseline|No Vitamin D|"No Vitamin D
Placebo: Placebo pill taken once daily for 3 month"
443302|NCT00585637|P4|Participant Flow|4000 IU of Vitamin D|"4000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443303|NCT00585637|P3|Participant Flow|2000 IU of Vitamin D|"2000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443304|NCT00585637|P2|Participant Flow|1000 IU of Vitamin D|"1000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443305|NCT00585637|P1|Participant Flow|No Vitamin D|"No Vitamin D
Placebo: Placebo pill taken once daily for 3 month"
443306|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443307|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443308|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443309|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D
Placebo: Placebo pill taken once daily for 3 month"
443310|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443311|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443312|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443313|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D
Placebo: Placebo pill taken once daily for 3 month"
443314|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443315|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443316|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443317|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D
Placebo: Placebo pill taken once daily for 3 month"
443318|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443319|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443320|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443321|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D
Placebo: Placebo pill taken once daily for 3 month"
443322|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443323|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443324|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443325|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D
Placebo: Placebo pill taken once daily for 3 month"
443326|NCT00585637|E4|Reported Event|4000 IU of Vitamin D|"4000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443327|NCT00585637|E3|Reported Event|2000 IU of Vitamin D|"2000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443328|NCT00585637|E2|Reported Event|1000 IU of Vitamin D|"1000 IU of Vitamin D
Vitamin D: Taken orally every day for three months"
443329|NCT00585637|E1|Reported Event|No Vitamin D|"No Vitamin D
Placebo: Placebo pill taken once daily for 3 month"
443330|NCT00585650|B3|Baseline|Total|Total of all reporting groups
443331|NCT00585650|B2|Baseline|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
443468|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
446781|NCT00603525|O1|Outcome|Placebo|
443332|NCT00585650|B1|Baseline|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
443333|NCT00585650|P2|Participant Flow|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
443334|NCT00585650|P1|Participant Flow|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
443335|NCT00585650|O2|Outcome|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
443336|NCT00585650|O1|Outcome|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
443337|NCT00585650|E2|Reported Event|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
443338|NCT00585650|E1|Reported Event|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
443339|NCT00585689|B1|Baseline|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
443340|NCT00585689|P1|Participant Flow|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
443341|NCT00585689|O1|Outcome|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
443342|NCT00585689|E1|Reported Event|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
443343|NCT00585715|B3|Baseline|Total|Total of all reporting groups
443344|NCT00585715|B2|Baseline|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
443345|NCT00585715|B1|Baseline|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
443346|NCT00585715|P2|Participant Flow|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
443347|NCT00585715|P1|Participant Flow|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
443348|NCT00585715|O2|Outcome|Laser Without Cooling for Skin Tightening|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
443349|NCT00585715|O1|Outcome|Laser With Cooling for Skin Tightening|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
443350|NCT00585715|O2|Outcome|Laser Without Cooling for Skin Tightening|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
443351|NCT00585715|O1|Outcome|Laser With Cooling for Skin Tightening|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
443352|NCT00585715|E2|Reported Event|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
443353|NCT00585715|E1|Reported Event|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
443354|NCT00585910|B1|Baseline|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
443355|NCT00585910|P1|Participant Flow|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
443356|NCT00585910|O1|Outcome|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
443357|NCT00585910|O1|Outcome|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
443358|NCT00585910|E2|Reported Event|ATMX and OROS MPH|Partial responders to ATMX alone entered into the ATMX and OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
443359|NCT00585910|E1|Reported Event|ATMX Only|Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase.
443360|NCT00585923|B3|Baseline|Total|Total of all reporting groups
443361|NCT00585923|B2|Baseline|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
443362|NCT00585923|B1|Baseline|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
456467|NCT00623779|E3|Reported Event|Standard Therapy|Standard Therapy
443366|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
443367|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
443368|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
443369|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
443370|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
443371|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
443372|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
443373|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
443374|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
443375|NCT00585923|E2|Reported Event|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
443376|NCT00585923|E1|Reported Event|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
443377|NCT00585975|B3|Baseline|Total|Total of all reporting groups
443378|NCT00585975|B2|Baseline|Xibrom 0.09%|
443379|NCT00585975|B1|Baseline|Bromfenac Ophthalmic Solution 0.18%|
443380|NCT00585975|P2|Participant Flow|Xibrom 0.09%|
443381|NCT00585975|P1|Participant Flow|Bromfenac Ophthalmic Solution 0.18%|
443382|NCT00585975|O2|Outcome|Xibrom 0.09%|
443383|NCT00585975|O1|Outcome|Bromfenac Ophthalmic Solution 0.18%|
443384|NCT00585975|O2|Outcome|Xibrom 0.09%|
443385|NCT00585975|O1|Outcome|Bromfenac Ophthalmic Solution 0.18%|
443386|NCT00585975|E2|Reported Event|Xibrom 0.09%|
443387|NCT00585975|E1|Reported Event|Bromfenac Ophthalmic Solution 0.18%|
443388|NCT00586066|B3|Baseline|Total|Total of all reporting groups
443389|NCT00586066|B2|Baseline|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
443390|NCT00586066|B1|Baseline|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
443391|NCT00586066|P2|Participant Flow|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
443392|NCT00586066|P1|Participant Flow|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
443393|NCT00586066|O2|Outcome|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
443394|NCT00586066|O1|Outcome|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
443395|NCT00586066|O2|Outcome|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
446782|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
443396|NCT00586066|O1|Outcome|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
443397|NCT00586066|O2|Outcome|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
443398|NCT00586066|O1|Outcome|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
443399|NCT00586066|E2|Reported Event|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
443443|NCT00586196|O2|Outcome|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
443400|NCT00586066|E1|Reported Event|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
443401|NCT00586105|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443402|NCT00586105|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443403|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443404|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443405|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443406|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443407|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443408|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443409|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443410|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443411|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443412|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443413|NCT00586105|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
443414|NCT00586157|B1|Baseline|Entire Study Population|
443415|NCT00586157|P2|Participant Flow|Placebo Then MTS|Placebo in first intervention then MTS in second intervention
443416|NCT00586157|P1|Participant Flow|MTS Then Placebo|MTS in first intervention then Placebo in second intervention
443417|NCT00586157|O2|Outcome|Placebo|
443418|NCT00586157|O1|Outcome|MTS (Drug A)|
443419|NCT00586157|O2|Outcome|Placebo|
443420|NCT00586157|O1|Outcome|MTS (Drug A)|
443421|NCT00586157|O2|Outcome|Placebo|
443422|NCT00586157|O1|Outcome|MTS (Drug A)|
443423|NCT00586157|E2|Reported Event|Placebo|
443424|NCT00586157|E1|Reported Event|MTS (Drug A)|
443425|NCT00586170|B3|Baseline|Total|Total of all reporting groups
443426|NCT00586170|B2|Baseline|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Placebo Device: 10 hours of treatment per day for up to 24 weeks
Surgery: Open Reduction and Internal Fixation of the nonunion site"
443427|NCT00586170|B1|Baseline|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks
Surgery: Open Reduction and Internal Fixation of the nonunion site"
443428|NCT00586170|P2|Participant Flow|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Placebo Device: 10 hours of treatment per day for up to 24 weeks
Surgery: Open Reduction and Internal Fixation of the nonunion site"
443429|NCT00586170|P1|Participant Flow|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks
Surgery: Open Reduction and Internal Fixation of the nonunion site"
443430|NCT00586170|O2|Outcome|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Placebo Device: 10 hours of treatment per day for up to 24 weeks
Surgery: Open Reduction and Internal Fixation of the nonunion site"
443431|NCT00586170|O1|Outcome|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks
Surgery: Open Reduction and Internal Fixation of the nonunion site"
443432|NCT00586170|O2|Outcome|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Placebo Device: 10 hours of treatment per day for up to 24 weeks
Surgery: Open Reduction and Internal Fixation of the nonunion site"
443469|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
443433|NCT00586170|O1|Outcome|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks
Surgery: Open Reduction and Internal Fixation of the nonunion site"
443434|NCT00586170|E2|Reported Event|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Placebo Device: 10 hours of treatment per day for up to 24 weeks
Surgery: Open Reduction and Internal Fixation of the nonunion site"
443435|NCT00586170|E1|Reported Event|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks
Surgery: Open Reduction and Internal Fixation of the nonunion site"
443436|NCT00586196|B3|Baseline|Total|Total of all reporting groups
443437|NCT00586196|B2|Baseline|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
443438|NCT00586196|B1|Baseline|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
443439|NCT00586196|P2|Participant Flow|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
443440|NCT00586196|P1|Participant Flow|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
443441|NCT00586196|O2|Outcome|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
456468|NCT00623779|E2|Reported Event|AZD0837 300 mg|AZD0837 300 mg
443444|NCT00586196|O1|Outcome|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
443445|NCT00586196|E2|Reported Event|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
443446|NCT00586196|E1|Reported Event|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
443447|NCT00586261|B3|Baseline|Total|Total of all reporting groups
443448|NCT00586261|B2|Baseline|Placebo Arm|"study the specific dose of placebo 30 mg daily for 6 months
placebo : placebo 30 mg daily for 6 months"
443449|NCT00586261|B1|Baseline|Pioglitazone Arm|"study the specific dose of pioglitazone 30 mg daily for 6 months
pioglitazone : pioglitazone 30 mg daily for 6 months"
443450|NCT00586261|P2|Participant Flow|Placebo|Placebo 30 mg daily for 6 months
443451|NCT00586261|P1|Participant Flow|Pioglitazone|Pioglitazone 30 mg daily for 6 months
443452|NCT00586261|O2|Outcome|Placebo Arm|"study the specific dose of placebo 30 mg daily for 6 months
placebo : placebo 30 mg daily for 6 months"
443453|NCT00586261|O1|Outcome|Pioglitazone Arm|"study the specific dose of pioglitazone 30 mg daily for 6 months
pioglitazone : pioglitazone 30 mg daily for 6 months"
443454|NCT00586261|E2|Reported Event|Placebo|Placebo 30 mg daily for six months
443455|NCT00586261|E1|Reported Event|Pioglitazone|Pioglitazone 30 mg daily for six months
443456|NCT00586313|B1|Baseline|Participants Undergoing the Tru-Cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.
EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
443457|NCT00586313|P1|Participant Flow|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.
EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
443458|NCT00586313|O1|Outcome|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.
EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
443459|NCT00586313|O1|Outcome|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.
EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
443460|NCT00586313|E1|Reported Event|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.
EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
443461|NCT00586326|B1|Baseline|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
443462|NCT00586326|P1|Participant Flow|Enrolled|Women with DCIS who were willing to enroll and consented
443463|NCT00586326|O4|Outcome|Poor|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years
443464|NCT00586326|O3|Outcome|Fair|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years
443465|NCT00586326|O2|Outcome|Good|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years
443466|NCT00586326|O1|Outcome|Excellent|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Excellent' at 5 years
443467|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
446783|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
443470|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
443471|NCT00586326|E1|Reported Event|Intent to Treat|Enrolled subjects with MammoSite device placed
443472|NCT00586339|B4|Baseline|Total|Total of all reporting groups
443473|NCT00586339|B3|Baseline|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443474|NCT00586339|B2|Baseline|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443475|NCT00586339|B1|Baseline|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443476|NCT00586339|P3|Participant Flow|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443721|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443477|NCT00586339|P2|Participant Flow|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443478|NCT00586339|P1|Participant Flow|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443479|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443480|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443481|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443482|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443483|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443484|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443485|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443486|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443487|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443488|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443489|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443490|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443491|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443492|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443593|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
446784|NCT00603525|O1|Outcome|Placebo|
443493|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443494|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443495|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443496|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443497|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443498|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443499|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443500|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443501|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443502|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443503|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443504|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443505|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443506|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443507|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443508|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443509|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443510|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443511|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443512|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443513|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443594|NCT00586469|E2|Reported Event|New Bulk|This group received a full dose of Fluviral made from new material
446785|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
443514|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443515|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443516|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443517|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443518|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443519|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443520|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443521|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443522|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443523|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443524|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443525|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443526|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443527|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443528|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443529|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443530|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443531|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443532|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443533|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443534|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443595|NCT00586469|E1|Reported Event|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443596|NCT00586482|B3|Baseline|Total|Total of all reporting groups
443535|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443536|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443537|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443538|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443539|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443540|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443541|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443542|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443543|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443544|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443545|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443546|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443547|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443548|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443549|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443550|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443551|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443552|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443553|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443554|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443555|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443750|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443556|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443557|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443558|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443559|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443560|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443561|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443562|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443563|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443564|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443565|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443566|NCT00586339|E3|Reported Event|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443567|NCT00586339|E2|Reported Event|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443568|NCT00586339|E1|Reported Event|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
443569|NCT00586469|B3|Baseline|Total|Total of all reporting groups
443570|NCT00586469|B2|Baseline|New Bulk|This group received a full dose of Fluviral made from new material
443571|NCT00586469|B1|Baseline|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443572|NCT00586469|P2|Participant Flow|New Bulk|This group received a full dose of Fluviral made from new material
443573|NCT00586469|P1|Participant Flow|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443574|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
443575|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443576|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
443577|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443578|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
443579|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443580|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
443581|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443582|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
443583|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443584|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
443585|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443586|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
443587|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443588|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
443589|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443590|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
443591|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
443592|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
443597|NCT00586482|B2|Baseline|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443598|NCT00586482|B1|Baseline|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443599|NCT00586482|P2|Participant Flow|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
456469|NCT00623779|E1|Reported Event|AZD0837 150 mg|AZD0837 150 mg
443600|NCT00586482|P1|Participant Flow|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443601|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443602|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443603|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443604|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443605|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443606|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443607|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443608|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443609|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443637|NCT00586612|P2|Participant Flow|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443610|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443611|NCT00586482|E2|Reported Event|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443641|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443902|NCT00596011|P1|Participant Flow|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
443612|NCT00586482|E1|Reported Event|Nicotine Lozenge|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
443613|NCT00586495|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
443614|NCT00586495|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
443615|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
443616|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
443617|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
443618|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
443619|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
443620|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
443621|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
443622|NCT00586495|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
443623|NCT00586521|B1|Baseline|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
443624|NCT00586521|P1|Participant Flow|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
443625|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
443626|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
443627|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
443628|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
443629|NCT00586521|E1|Reported Event|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
443630|NCT00586573|B1|Baseline|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
443631|NCT00586573|P1|Participant Flow|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
443632|NCT00586573|O1|Outcome|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
443633|NCT00586573|E1|Reported Event|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
443634|NCT00586612|B3|Baseline|Total|Total of all reporting groups
443635|NCT00586612|B2|Baseline|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443636|NCT00586612|B1|Baseline|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443875|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
443638|NCT00586612|P1|Participant Flow|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443639|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443640|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443797|NCT00586729|E2|Reported Event|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443642|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443643|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443644|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443645|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443646|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443647|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443648|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443649|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443650|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443651|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443652|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443653|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443654|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443655|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443656|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443657|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443658|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443659|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443660|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443714|NCT00586664|B2|Baseline|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443661|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443662|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443663|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443664|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443665|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443666|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443667|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443668|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443669|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443670|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443671|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443672|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443673|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443674|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443675|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443676|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443677|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443678|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443679|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443680|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443681|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443682|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443683|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443715|NCT00586664|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443684|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443685|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443686|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443687|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443688|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443689|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443690|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443691|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443692|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443693|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443694|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443695|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443696|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443697|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443698|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443699|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443700|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443701|NCT00586612|E2|Reported Event|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443702|NCT00586612|E1|Reported Event|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
443703|NCT00586625|B3|Baseline|Total|Total of all reporting groups
443704|NCT00586625|B2|Baseline|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
443705|NCT00586625|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
443706|NCT00586625|P2|Participant Flow|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
443707|NCT00586625|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
443708|NCT00586625|O2|Outcome|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
443709|NCT00586625|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
443710|NCT00586625|E2|Reported Event|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
443711|NCT00586625|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
443712|NCT00586664|B4|Baseline|Total|Total of all reporting groups
443713|NCT00586664|B3|Baseline|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443716|NCT00586664|P3|Participant Flow|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443717|NCT00586664|P2|Participant Flow|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443718|NCT00586664|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443719|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443720|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443900|NCT00596011|B1|Baseline|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
443722|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443723|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443724|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443725|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443726|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443727|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443728|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443729|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443730|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443731|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443732|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443733|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443734|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443735|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443736|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443737|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443738|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443739|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443740|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443741|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443742|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443743|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443744|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443745|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443746|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443747|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443748|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443749|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443876|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
443751|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443752|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443753|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443754|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443755|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443756|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
456470|NCT00623805|B3|Baseline|Total|Total of all reporting groups
443757|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443758|NCT00586664|E3|Reported Event|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443759|NCT00586664|E2|Reported Event|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443760|NCT00586664|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
443761|NCT00586690|B3|Baseline|Total|Total of all reporting groups
443762|NCT00586690|B2|Baseline|Donor Apheresis|Apheresis repeated daily up to 3 days until target dose of cells reached (preferably without donor receiving growth factors). Cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These extra cell collections from the donor were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
443763|NCT00586690|B1|Baseline|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
443764|NCT00586690|P2|Participant Flow|Donor Apheresis|Leukapheresis was repeated daily up to 3 days until the target dose of cells was reached (preferably without donor receiving growth factors). When possible, cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These collections, which are extra cells collected from the donor following initial collections for transplant were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
443765|NCT00586690|P1|Participant Flow|NK Cell Infusion|NK Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
443766|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
443767|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
443768|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
443769|NCT00586690|O1|Outcome|NK Cell Infusion|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody:
The cells from leukapheresis will be NK cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion."
443770|NCT00586690|E1|Reported Event|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
443771|NCT00586703|B1|Baseline|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors
NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
443772|NCT00586703|P1|Participant Flow|Experimental: NK-CD56|"NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from mismatched donors
NK Cell Infusion following SCT from mismatched donors : The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II aGVHD at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
443773|NCT00586703|O1|Outcome|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors
NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
443774|NCT00586703|O1|Outcome|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors
NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
443775|NCT00586703|E1|Reported Event|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors
NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
443776|NCT00586716|B3|Baseline|Total|Total of all reporting groups
443777|NCT00586716|B2|Baseline|IVIG With Living Donor|Intravenous immune globulin for patients who have living donors with positive crossmatch results.
443778|NCT00586716|B1|Baseline|IVIG no Living Donor|Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
443779|NCT00586716|P2|Participant Flow|Group 2 Intravenous Immune Globulin With Living Donor|"Patients who have living donors with positive crossmatch results.
intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
443780|NCT00586716|P1|Participant Flow|Group 1 Intravenous Immune Globulin no Living Donor|"Patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
443781|NCT00586716|O2|Outcome|Group 2 Intravenous Immune Globulin|"Intravenous immune globulin for patients who have living donors with positive crossmatch results.
intravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
443782|NCT00586716|O1|Outcome|Group 1 Intravenous Immune Globulin|"Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
intravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
443783|NCT00586716|O1|Outcome|Intravenous Immune Globulin|Intravenous immune globulin for patients who have living donors with positive crossmatch results
443784|NCT00586716|E2|Reported Event|Group 2 Intravenous Immune Globulin|Group 2 intravenous immune globulin WITH living donor
443785|NCT00586716|E1|Reported Event|Group 1 Intravenous Immune Globulin|Group 1 with Intravenous immune globulin with no living donor
443786|NCT00586729|B3|Baseline|Total|Total of all reporting groups
443787|NCT00586729|B2|Baseline|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443788|NCT00586729|B1|Baseline|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443789|NCT00586729|P2|Participant Flow|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443877|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
443790|NCT00586729|P1|Participant Flow|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443791|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443792|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443793|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443794|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443795|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443796|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443798|NCT00586729|E1|Reported Event|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
443799|NCT00586820|B3|Baseline|Total|Total of all reporting groups
443800|NCT00586820|B2|Baseline|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
443801|NCT00586820|B1|Baseline|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
443802|NCT00586820|P2|Participant Flow|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
443803|NCT00586820|P1|Participant Flow|BQ-123|The selective endothelin type A receptor antagonist (BQ-123) will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
443804|NCT00586820|O2|Outcome|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
443805|NCT00586820|O1|Outcome|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
443806|NCT00586820|O2|Outcome|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
443807|NCT00586820|O1|Outcome|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
443808|NCT00586820|E2|Reported Event|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion for 20 minutes prior to PCI.
443809|NCT00586820|E1|Reported Event|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
443810|NCT00586846|B1|Baseline|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
443811|NCT00586846|P1|Participant Flow|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
443812|NCT00586846|O1|Outcome|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
443813|NCT00586846|E1|Reported Event|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
443814|NCT00595764|B3|Baseline|Total|Total of all reporting groups
443815|NCT00595764|B2|Baseline|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
443816|NCT00595764|B1|Baseline|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
443817|NCT00595764|P2|Participant Flow|Physician Management Plus Cognitive Behavioral Therapy|In addition to recieving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
443818|NCT00595764|P1|Participant Flow|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
443878|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
443879|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
443819|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
443820|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
443901|NCT00596011|P2|Participant Flow|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
443821|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
443822|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
443823|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
443824|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
443825|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
443826|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
443827|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
443880|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
443881|NCT00595946|E2|Reported Event|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
443882|NCT00595946|E1|Reported Event|Placebo|Placebo : 0 mcg capsules twice daily (BID)
443883|NCT00595959|B1|Baseline|Laser Treatment|CLiRpath Photoablation Atherectomy System
443884|NCT00595959|P1|Participant Flow|Laser Treatment|CLiRpath Photoablation Atherectomy System
443885|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443828|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
443829|NCT00595764|E2|Reported Event|Physician Management Plus Cognitive Behavioral Therapy|In addition to recieving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
443830|NCT00595764|E1|Reported Event|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
443831|NCT00595790|B4|Baseline|Total|Total of all reporting groups
443832|NCT00595790|B3|Baseline|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
443833|NCT00595790|B2|Baseline|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
443834|NCT00595790|B1|Baseline|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
443835|NCT00595790|P3|Participant Flow|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
443836|NCT00595790|P2|Participant Flow|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
443837|NCT00595790|P1|Participant Flow|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
443838|NCT00595790|O3|Outcome|IC51 1x6 mcg|
443839|NCT00595790|O2|Outcome|IC51 2x6 mcg|
443840|NCT00595790|O1|Outcome|IC51 1 x 12 mcg|
443841|NCT00595790|E3|Reported Event|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
443842|NCT00595790|E2|Reported Event|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
443843|NCT00595790|E1|Reported Event|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
443844|NCT00595868|B3|Baseline|Total|Total of all reporting groups
443845|NCT00595868|B2|Baseline|Placebo|Placebo once per day for 2-8 weeks
443846|NCT00595868|B1|Baseline|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
443847|NCT00595868|P2|Participant Flow|Placebo|Placebo once per day for 2-8 weeks
443848|NCT00595868|P1|Participant Flow|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
443849|NCT00595868|O2|Outcome|Placebo|Placebo once per day for 2-8 weeks
443850|NCT00595868|O1|Outcome|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
443851|NCT00595868|O2|Outcome|Placebo|Placebo once per day for 2-8 weeks
443852|NCT00595868|O1|Outcome|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
443853|NCT00595868|E2|Reported Event|Placebo|Placebo once per day for 2-8 weeks
443854|NCT00595868|E1|Reported Event|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
443855|NCT00595881|B1|Baseline|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
443856|NCT00595881|P1|Participant Flow|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
443857|NCT00595881|O2|Outcome|Clinical Exam+ Ultrasound|Patients will have data collected following the addition of a bedside ultrasound performed to the clinical exam.
443858|NCT00595881|O1|Outcome|Clinical Exam Alone|Patients will have data collected from their clinical examination alone
443859|NCT00595881|E1|Reported Event|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
443860|NCT00595920|B1|Baseline|Open Label Extension|"30-45 million autologous myelin reactive T cells
Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
443861|NCT00595920|P1|Participant Flow|Open Label Extension|"30-45 million autologous myelin reactive T cells
Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
443862|NCT00595920|O1|Outcome|Open Label Extension|"30-45 million autologous myelin reactive T cells
Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
443863|NCT00595920|E1|Reported Event|Open Label Extension|"30-45 million autologous myelin reactive T cells
Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
443864|NCT00595946|B3|Baseline|Total|Total of all reporting groups
443865|NCT00595946|B2|Baseline|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
443866|NCT00595946|B1|Baseline|Placebo|Placebo : 0 mcg capsules twice daily (BID)
443867|NCT00595946|P2|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID) for up to 12 weeks
443868|NCT00595946|P1|Participant Flow|Placebo|Placebo : 0 mcg capsules twice daily (BID) for up to 12 weeks
443869|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
443870|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
443871|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
443872|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
443873|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
443874|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
443887|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443888|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443889|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443890|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443891|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443892|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443893|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443894|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443895|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443896|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
443897|NCT00595959|E1|Reported Event|Laser Treatment|CLiRpath Photoablation Atherectomy System
443898|NCT00596011|B3|Baseline|Total|Total of all reporting groups
443899|NCT00596011|B2|Baseline|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
444653|NCT00590759|P1|Participant Flow|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
443903|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
443904|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
443905|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
443906|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
443907|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
443908|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
443909|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
443910|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
443911|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
443912|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
443913|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
443914|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
443915|NCT00596011|E2|Reported Event|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
443916|NCT00596011|E1|Reported Event|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
443917|NCT00596102|B4|Baseline|Total|Total of all reporting groups
443918|NCT00596102|B3|Baseline|Placebo|no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302
443919|NCT00596102|B2|Baseline|JE-VAX|no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301
443920|NCT00596102|B1|Baseline|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
443921|NCT00596102|P3|Participant Flow|Placebo|no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302
443922|NCT00596102|P2|Participant Flow|JE-VAX|no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301
443923|NCT00596102|P1|Participant Flow|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
443924|NCT00596102|O1|Outcome|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
443925|NCT00596102|E4|Reported Event|IC51 Month 60|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 60
443926|NCT00596102|E3|Reported Event|Placebo|no active treatment in study IC51-303, Plarcebo vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
443927|NCT00596102|E2|Reported Event|JE-VAX|no active treatment in study IC51-303, JE-VAX vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
443928|NCT00596102|E1|Reported Event|IC51 Month 6|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
443929|NCT00597116|B3|Baseline|Total|Total of all reporting groups
443930|NCT00597116|B2|Baseline|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
443931|NCT00597116|B1|Baseline|Vandetanib|Vandetanib 300 mg/day oral
443932|NCT00597116|P2|Participant Flow|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
443933|NCT00597116|P1|Participant Flow|Vandetanib|Vandetanib 300 mg/day oral
443934|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
443935|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
443936|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
443937|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
443938|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
443939|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
443940|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
443941|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
443942|NCT00597116|E2|Reported Event|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
443943|NCT00597116|E1|Reported Event|Vandetanib|Vandetanib 300 mg/day oral
443944|NCT00597207|B3|Baseline|Total|Total of all reporting groups
443945|NCT00597207|B2|Baseline|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.
Manual: Manual chest compression"
443946|NCT00597207|B1|Baseline|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.
AutoPulse: Mechanical device that provides chest compression"
443947|NCT00597207|P2|Participant Flow|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.
Manual: Manual chest compression"
443948|NCT00597207|P1|Participant Flow|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.
AutoPulse: Mechanical device that provides chest compression"
443949|NCT00597207|O2|Outcome|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.
Manual: Manual chest compression"
443950|NCT00597207|O1|Outcome|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.
AutoPulse: Mechanical device that provides chest compression"
443951|NCT00597207|E2|Reported Event|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.
Manual: Manual chest compression"
443952|NCT00597207|E1|Reported Event|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.
AutoPulse: Mechanical device that provides chest compression"
443953|NCT00597272|B8|Baseline|Total|Total of all reporting groups
443954|NCT00597272|B7|Baseline|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
443955|NCT00597272|B6|Baseline|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
443956|NCT00597272|B5|Baseline|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
443957|NCT00597272|B4|Baseline|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
443958|NCT00597272|B3|Baseline|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443959|NCT00597272|B2|Baseline|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443960|NCT00597272|B1|Baseline|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443961|NCT00597272|P7|Participant Flow|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
443962|NCT00597272|P6|Participant Flow|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
443963|NCT00597272|P5|Participant Flow|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
443964|NCT00597272|P4|Participant Flow|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
443965|NCT00597272|P3|Participant Flow|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443966|NCT00597272|P2|Participant Flow|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443967|NCT00597272|P1|Participant Flow|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443968|NCT00597272|O7|Outcome|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
443969|NCT00597272|O6|Outcome|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
443970|NCT00597272|O5|Outcome|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
443971|NCT00597272|O4|Outcome|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
443972|NCT00597272|O3|Outcome|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443973|NCT00597272|O2|Outcome|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443974|NCT00597272|O1|Outcome|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443975|NCT00597272|E7|Reported Event|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
443976|NCT00597272|E6|Reported Event|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
443977|NCT00597272|E5|Reported Event|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
443978|NCT00597272|E4|Reported Event|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
443979|NCT00597272|E3|Reported Event|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443980|NCT00597272|E2|Reported Event|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443981|NCT00597272|E1|Reported Event|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
443982|NCT00597376|B3|Baseline|Total|Total of all reporting groups
443983|NCT00597376|B2|Baseline|Cerefolin NAC Placebo + Multivitamin|"On placebo and open label multivitamin supplement
Cerefolin NAC placebo : Placebo tablet once a day"
443984|NCT00597376|B1|Baseline|Cerefolin NAC + Multivitamin|"On Cerefolin NAC and open-label multivitamin supplement
Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day"
443985|NCT00597376|P2|Participant Flow|Cerefolin NAC Placebo + Multivitamin|"On placebo and open label multivitamin supplement
Cerefolin NAC placebo : Placebo tablet once a day"
443986|NCT00597376|P1|Participant Flow|Cerefolin NAC + Multivitamin|"On Cerefolin NAC and open-label multivitamin supplement
Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day"
443987|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
443988|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
443989|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
443990|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
443991|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
443992|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
443993|NCT00597376|E2|Reported Event|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
443994|NCT00597376|E1|Reported Event|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
443995|NCT00597402|B1|Baseline|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.
Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
443996|NCT00597402|P1|Participant Flow|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.
Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
443997|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.
Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
443998|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.
Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
443999|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.
Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
444000|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.
Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
444001|NCT00597402|E1|Reported Event|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.
Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
444002|NCT00597428|B3|Baseline|Total|Total of all reporting groups
444003|NCT00597428|B2|Baseline|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
444004|NCT00597428|B1|Baseline|Placebo|Placebo : 0 mcg capsules twice daily (BID)
444005|NCT00597428|P2|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID) for 12 weeks
444006|NCT00597428|P1|Participant Flow|Placebo|Placebo : 0 mcg capsules twice daily (BID) for 12 weeks
444007|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
444008|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
444009|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
444010|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
444011|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
444012|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
444013|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
444014|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
444015|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
444016|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
444017|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
444018|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
444019|NCT00597428|E2|Reported Event|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
444020|NCT00597428|E1|Reported Event|Placebo|Placebo : 0 mcg capsules twice daily (BID)
444021|NCT00597493|B1|Baseline|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily
Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
444022|NCT00597493|P1|Participant Flow|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily
Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
444023|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
444024|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
444025|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
444026|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
444027|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
444028|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
444029|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
444030|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
444031|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
444032|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
444033|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
444034|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
444035|NCT00597493|O1|Outcome|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily
Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
444036|NCT00597493|O1|Outcome|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily
Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
444037|NCT00597493|E1|Reported Event|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily
Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
444038|NCT00597506|B1|Baseline|Bevacizumab and Everolimus|Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
444039|NCT00597506|P1|Participant Flow|Drug: Bevacizumab and Everolimus|Open-label, non-randomized expanded cohort trial of refractory metastatic colorectal cancer subjects treated on 28 day cycles with the following treatment regimen: 10 mg/kg intravenous bevacizumab on days 1 and 15 each cycle and 10 mg everolimus(RAD001) daily by mouth.
444040|NCT00597506|O1|Outcome|Bevacizumab and Everolimus|Enrolled participants on research study received bevacizumab at 10mg/kg every 2 weeks (day 1 and day 15 of each 28 day cycle) and everolimus at 10mg orally daily
444041|NCT00597506|O1|Outcome|Bevacizumab and Everolimus|Enrolled participants on research study received bevacizumab at 10mg/kg every 2 weeks (day 1 and day 15 of each 28 day cycle) and everolimus at 10mg orally daily
444042|NCT00597506|E1|Reported Event|Bevacizumab and Everolimus|Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
444043|NCT00597519|B1|Baseline|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
444044|NCT00597519|P1|Participant Flow|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
444045|NCT00597519|O1|Outcome|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
444046|NCT00597519|E1|Reported Event|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
444047|NCT00597545|B3|Baseline|Total|Total of all reporting groups
444083|NCT00597675|O2|Outcome|Peanut OIT|Peanut flour ingested daily as active OIT treatment
444084|NCT00597675|O1|Outcome|Placebo|Oat flour taken daily as a placebo
444085|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
446786|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
444048|NCT00597545|B2|Baseline|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.
Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain
Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
444049|NCT00597545|B1|Baseline|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.
Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain
Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
444050|NCT00597545|P2|Participant Flow|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.
Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain
Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
444097|NCT00597701|E1|Reported Event|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
444098|NCT00597714|B3|Baseline|Total|Total of all reporting groups
444051|NCT00597545|P1|Participant Flow|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.
Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain
Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
444052|NCT00597545|O2|Outcome|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.
Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain
Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
444053|NCT00597545|O1|Outcome|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.
Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain
Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
444054|NCT00597545|E2|Reported Event|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.
Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain
Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
444055|NCT00597545|E1|Reported Event|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.
Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain
Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
444056|NCT00597558|B1|Baseline|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
444057|NCT00597558|P1|Participant Flow|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
444058|NCT00597558|O1|Outcome|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
444059|NCT00597558|O1|Outcome|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
444060|NCT00597558|O1|Outcome|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
444061|NCT00597558|E1|Reported Event|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
444062|NCT00597584|B3|Baseline|Total|Total of all reporting groups
444063|NCT00597584|B2|Baseline|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444064|NCT00597584|B1|Baseline|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444065|NCT00597584|P2|Participant Flow|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444086|NCT00597675|E3|Reported Event|Blinded Phase-Peanut OIT|Patients receiving peanut flour as active OIT during the initial 12 months of therapy.
444087|NCT00597675|E2|Reported Event|Blinded Phase-Placebo|Patients receiving oat flour as a placebo during the initial 12 months of therapy.
444088|NCT00597675|E1|Reported Event|Open Label Phase-Peanut OIT|All subjects receiving open-label peanut OIT from the point of unblinding through the end of the treatment phase.
444089|NCT00597701|B3|Baseline|Total|Total of all reporting groups
446787|NCT00603525|O1|Outcome|Placebo|
444066|NCT00597584|P1|Participant Flow|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444067|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444068|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444069|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444070|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444071|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444072|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444073|NCT00597584|E2|Reported Event|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444074|NCT00597584|E1|Reported Event|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.
The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
444075|NCT00597675|B3|Baseline|Total|Total of all reporting groups
444076|NCT00597675|B2|Baseline|Peanut OIT|Peanut flour ingested daily as active OIT treatment
444077|NCT00597675|B1|Baseline|Placebo|Oat flour taken daily as a placebo
444078|NCT00597675|P2|Participant Flow|Peanut OIT|Peanut flour ingested daily as active OIT treatment
444079|NCT00597675|P1|Participant Flow|Placebo|Oat flour taken daily as a placebo
444080|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
444081|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
444082|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
444090|NCT00597701|B2|Baseline|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
444091|NCT00597701|B1|Baseline|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
444092|NCT00597701|P2|Participant Flow|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
444093|NCT00597701|P1|Participant Flow|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
444094|NCT00597701|O2|Outcome|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
444095|NCT00597701|O1|Outcome|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
444096|NCT00597701|E2|Reported Event|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
444099|NCT00597714|B2|Baseline|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444100|NCT00597714|B1|Baseline|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444101|NCT00597714|P3|Participant Flow|Donor|"5-6/6 matched sibling who meets the other donor criteria is the first choice,
Matched Unrelated Donor (MUD) is the second choice*, and
3-5/6 partially matched family member (if 5/6 then this donor is not a sibling as that would be first choice) is the third choice for donor type.
Multiple choices for 3-5/6 human leukocyte antigen (HLA) matched family member donors order of choice will be best match, then cytomegalovirus (CMV) negativity, then Killer-cell immunoglobulin-like receptors (KIR) mismatching (for natural killer [NK] cell activity), then history of pregnancy. All subjects without an available matched sibling must have a donor search initiated with the national bank. If potential high resolution matches are found but not utilized, the reason for proceeding with a partially matched family member should be documented (i.e. donor not available, not enough time to allow MUD donor work up and collection due to high risk nature of the subject's disease, etc)."
444102|NCT00597714|P2|Participant Flow|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444103|NCT00597714|P1|Participant Flow|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444104|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours.The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444118|NCT00597727|P4|Participant Flow|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
444181|NCT00597909|P2|Participant Flow|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
444105|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours.The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444122|NCT00597727|O3|Outcome|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
444123|NCT00597727|O2|Outcome|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
444185|NCT00597909|O1|Outcome|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
444106|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444107|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. For the myeloid group, the prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444108|NCT00597714|O1|Outcome|Cohort A & B- Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444109|NCT00597714|O1|Outcome|Cohort A & B- Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444110|NCT00597714|E2|Reported Event|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444111|NCT00597714|E1|Reported Event|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
444112|NCT00597727|B5|Baseline|Total|Total of all reporting groups
444113|NCT00597727|B4|Baseline|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
444114|NCT00597727|B3|Baseline|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
444115|NCT00597727|B2|Baseline|Blinded Placebo SLIT|"Blinded subjects who receive placebo (glycerin sublingual drops) at the beginning of the study.
Placebo SLIT: Liquid glycerin without peanut which are dosed under the tongue."
444116|NCT00597727|B1|Baseline|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops) at the beginning of the study.
444117|NCT00597727|P5|Participant Flow|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
444119|NCT00597727|P3|Participant Flow|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
444120|NCT00597727|P2|Participant Flow|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
444121|NCT00597727|P1|Participant Flow|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
444649|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444124|NCT00597727|O1|Outcome|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
444125|NCT00597727|O4|Outcome|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
444126|NCT00597727|O3|Outcome|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
444127|NCT00597727|O2|Outcome|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
444128|NCT00597727|O1|Outcome|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
444129|NCT00597727|E5|Reported Event|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
444130|NCT00597727|E4|Reported Event|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
444131|NCT00597727|E3|Reported Event|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
444132|NCT00597727|E2|Reported Event|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
444133|NCT00597727|E1|Reported Event|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
444134|NCT00597753|B3|Baseline|Total|Total of all reporting groups
444135|NCT00597753|B2|Baseline|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444136|NCT00597753|B1|Baseline|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444137|NCT00597753|P2|Participant Flow|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444138|NCT00597753|P1|Participant Flow|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444139|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444140|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444180|NCT00597909|P3|Participant Flow|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
446788|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
444141|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444142|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444650|NCT00590720|E2|Reported Event|MEDI528 50 mg|
444651|NCT00590720|E1|Reported Event|PLACEBO|
444143|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444144|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444145|NCT00597753|E2|Reported Event|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444146|NCT00597753|E1|Reported Event|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
444147|NCT00597896|B3|Baseline|Total|Total of all reporting groups
444148|NCT00597896|B2|Baseline|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444149|NCT00597896|B1|Baseline|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
444150|NCT00597896|P2|Participant Flow|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444151|NCT00597896|P1|Participant Flow|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
444152|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444153|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
444154|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444155|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
444156|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444157|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
444158|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444159|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
444160|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444161|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
444162|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444163|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
444164|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444165|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
444166|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444167|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
444168|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444169|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
444170|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444171|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
444172|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444173|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
444174|NCT00597896|E2|Reported Event|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
444175|NCT00597896|E1|Reported Event|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
444176|NCT00597909|B4|Baseline|Total|Total of all reporting groups
444177|NCT00597909|B3|Baseline|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
444178|NCT00597909|B2|Baseline|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
444179|NCT00597909|B1|Baseline|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
444182|NCT00597909|P1|Participant Flow|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
444183|NCT00597909|O3|Outcome|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
444184|NCT00597909|O2|Outcome|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
444282|NCT00598689|B2|Baseline|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
444186|NCT00597909|E3|Reported Event|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
444187|NCT00597909|E2|Reported Event|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
444188|NCT00597909|E1|Reported Event|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
444189|NCT00598078|B1|Baseline|All Study Participants|All treated study participants
444190|NCT00598078|P2|Participant Flow|Regimen A, Then C, Then B|Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2: Placebo at ~8am, ~10am, and ~12pm; Day 3: Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm;
444191|NCT00598078|P1|Participant Flow|Regimen A, Then B, Then C|Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2:Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm; Day 3:Placebo at ~8am, ~10am, and ~12pm
444192|NCT00598078|O3|Outcome|Placebo (C)|Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
444193|NCT00598078|O2|Outcome|Sodium Oxybate 3 Grams (B)|Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3)
444194|NCT00598078|O1|Outcome|Sodium Oxybate 1.5 Grams (A)|Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only)
444195|NCT00598078|E3|Reported Event|Placebo (C)|Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
444196|NCT00598078|E2|Reported Event|Sodium Oxybate 3 Grams (B)|Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3)
444197|NCT00598078|E1|Reported Event|Sodium Oxybate 1.5 Grams (A)|Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only)
444198|NCT00598273|B4|Baseline|Total|Total of all reporting groups
444199|NCT00598273|B3|Baseline|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444200|NCT00598273|B2|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444201|NCT00598273|B1|Baseline|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444202|NCT00598273|P3|Participant Flow|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444203|NCT00598273|P2|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444204|NCT00598273|P1|Participant Flow|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444205|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444206|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444207|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444208|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444209|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444210|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444377|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444211|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444212|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444213|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444214|NCT00598273|E3|Reported Event|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444215|NCT00598273|E2|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444216|NCT00598273|E1|Reported Event|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444217|NCT00598442|B4|Baseline|Total|Total of all reporting groups
444218|NCT00598442|B3|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444219|NCT00598442|B2|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444220|NCT00598442|B1|Baseline|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444221|NCT00598442|P3|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444222|NCT00598442|P2|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444223|NCT00598442|P1|Participant Flow|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444224|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444225|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444226|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444227|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444228|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444229|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444230|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444231|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444232|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444233|NCT00598442|E3|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444234|NCT00598442|E2|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
444235|NCT00598442|E1|Reported Event|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
444236|NCT00598507|B1|Baseline|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
444237|NCT00598507|P1|Participant Flow|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
444238|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
444239|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
444240|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
444241|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
444652|NCT00590759|B1|Baseline|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
444242|NCT00598507|E1|Reported Event|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
444243|NCT00598559|B4|Baseline|Total|Total of all reporting groups
444244|NCT00598559|B3|Baseline|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
444245|NCT00598559|B2|Baseline|IV Acetaminophen 650 mg q4h|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
444246|NCT00598559|B1|Baseline|IV Acetaminophen 1g q6h|All Subjects Randomized to Receive IV acetaminophen 1g administered every 6 hours.
444247|NCT00598559|P3|Participant Flow|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
444248|NCT00598559|P2|Participant Flow|IV Acetaminophen 650 Milligram Every 4 Hours|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
444249|NCT00598559|P1|Participant Flow|IV Acetaminophen 1 Gram Every 6 Hours|All Subjects Randomized to Receive IV acetaminophen 1 gram administered every 6 hours.
444250|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
444251|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
444252|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
444253|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
444254|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
444255|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
444256|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
444257|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
444258|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
444259|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
444260|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
444261|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
444262|NCT00598559|E3|Reported Event|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
444263|NCT00598559|E2|Reported Event|IV Acetaminophen 650 Milligram Every 4 Hours|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
444264|NCT00598559|E1|Reported Event|IV Acetaminophen 1 Gram Every 6 Hours|All Subjects Randomized to Receive IV acetaminophen 1 gram administered every 6 hours.
444265|NCT00598585|B3|Baseline|Total|Total of all reporting groups
444266|NCT00598585|B2|Baseline|Placebo|Placebo: Placebo tid for 6 weeks
444267|NCT00598585|B1|Baseline|Sildenafil|Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
444268|NCT00598585|P2|Participant Flow|Placebo|Placebo: Placebo
444269|NCT00598585|P1|Participant Flow|Sildenafil|25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
444270|NCT00598585|O2|Outcome|Placebo|Placebo: Placebo
444271|NCT00598585|O1|Outcome|Sildenafil|Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
444272|NCT00598585|E2|Reported Event|Placebo|Placebo: Placebo
444273|NCT00598585|E1|Reported Event|Sildenafil|Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
444274|NCT00598650|B1|Baseline|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
444275|NCT00598650|P1|Participant Flow|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
444276|NCT00598650|O2|Outcome|Placebo/E2020|Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group).
444277|NCT00598650|O1|Outcome|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
446789|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
444278|NCT00598650|O2|Outcome|Placebo/E2020|Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group).
444279|NCT00598650|O1|Outcome|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
444280|NCT00598650|E1|Reported Event|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
444281|NCT00598689|B3|Baseline|Total|Total of all reporting groups
444283|NCT00598689|B1|Baseline|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.
0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
444284|NCT00598689|P2|Participant Flow|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
444285|NCT00598689|P1|Participant Flow|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.
0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
444286|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
444287|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.
0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
444288|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
444289|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.
0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
444290|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
444291|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.
0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
444292|NCT00598689|E2|Reported Event|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
444293|NCT00598689|E1|Reported Event|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.
0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
444294|NCT00598702|B9|Baseline|Total|Total of all reporting groups
444295|NCT00598702|B8|Baseline|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
444296|NCT00598702|B7|Baseline|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444297|NCT00598702|B6|Baseline|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444298|NCT00598702|B5|Baseline|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444299|NCT00598702|B4|Baseline|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444300|NCT00598702|B3|Baseline|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444301|NCT00598702|B2|Baseline|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444302|NCT00598702|B1|Baseline|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
444303|NCT00598702|P8|Participant Flow|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
444304|NCT00598702|P7|Participant Flow|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444305|NCT00598702|P6|Participant Flow|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444306|NCT00598702|P5|Participant Flow|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444307|NCT00598702|P4|Participant Flow|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444308|NCT00598702|P3|Participant Flow|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444309|NCT00598702|P2|Participant Flow|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
446790|NCT00603525|O1|Outcome|Placebo|
444310|NCT00598702|P1|Participant Flow|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
444311|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
444312|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444313|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444314|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444315|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444316|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444317|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444318|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
444319|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
444320|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444321|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444322|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444323|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444324|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444325|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444326|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
444327|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
444328|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444329|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444330|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444331|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444332|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444333|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444334|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
444335|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
444336|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444337|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444338|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444339|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444340|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444341|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444342|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
444343|NCT00598702|E8|Reported Event|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
444344|NCT00598702|E7|Reported Event|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444345|NCT00598702|E6|Reported Event|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444346|NCT00598702|E5|Reported Event|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444455|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint
TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
444347|NCT00598702|E4|Reported Event|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444348|NCT00598702|E3|Reported Event|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
444349|NCT00598702|E2|Reported Event|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
444350|NCT00598702|E1|Reported Event|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
444351|NCT00598806|B3|Baseline|Total|Total of all reporting groups
444352|NCT00598806|B2|Baseline|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
444353|NCT00598806|B1|Baseline|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
444354|NCT00598806|P2|Participant Flow|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
444355|NCT00598806|P1|Participant Flow|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
444356|NCT00598806|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
444357|NCT00598806|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
444358|NCT00598806|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
444359|NCT00598806|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
444360|NCT00598806|E2|Reported Event|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
444361|NCT00598806|E1|Reported Event|Apaziquone|Apaziquone: TURBT + a single intravesical dose of EOquin® 4mg in 40ml instilled into the bladder post-TURBT
444362|NCT00598819|B1|Baseline|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
444363|NCT00598819|P1|Participant Flow|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
444364|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
444365|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
444366|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
444367|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
444368|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
444369|NCT00598819|E1|Reported Event|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
444370|NCT00598832|B3|Baseline|Total|Total of all reporting groups
444371|NCT00598832|B2|Baseline|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444372|NCT00598832|B1|Baseline|Adapalene Lotion 0.1%|once a day for 12 weeks
444373|NCT00598832|P2|Participant Flow|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444374|NCT00598832|P1|Participant Flow|Adapalene Lotion 0.1%|once a day for 12 weeks
444375|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444376|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
444378|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
444379|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444380|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
444381|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444382|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
444383|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444384|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
444385|NCT00598832|E2|Reported Event|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444386|NCT00598832|E1|Reported Event|Adapalene Lotion 0.1%|once a day for 12 weeks
444387|NCT00598871|B3|Baseline|Total|Total of all reporting groups
444388|NCT00598871|B2|Baseline|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
444389|NCT00598871|B1|Baseline|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
444390|NCT00598871|P2|Participant Flow|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
444391|NCT00598871|P1|Participant Flow|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
444392|NCT00598871|O2|Outcome|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
444393|NCT00598871|O1|Outcome|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
444394|NCT00598871|O2|Outcome|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
444395|NCT00598871|O1|Outcome|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
444396|NCT00598871|E2|Reported Event|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
444397|NCT00598871|E1|Reported Event|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
444398|NCT00599014|B1|Baseline|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
444399|NCT00599014|P1|Participant Flow|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
444400|NCT00599014|O1|Outcome|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
444401|NCT00599014|O1|Outcome|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
444402|NCT00599014|E1|Reported Event|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
444403|NCT00599027|B3|Baseline|Total|Total of all reporting groups
444404|NCT00599027|B2|Baseline|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
444405|NCT00599027|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
444406|NCT00599027|P2|Participant Flow|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
444407|NCT00599027|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
444408|NCT00599027|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
444409|NCT00599027|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
444410|NCT00599027|E2|Reported Event|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
444411|NCT00599027|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
444412|NCT00599053|B3|Baseline|Total|Total of all reporting groups
444413|NCT00599053|B2|Baseline|Expectant (Usual) Management|Intervention at the discretion of the attending physician
444414|NCT00599053|B1|Baseline|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
444415|NCT00599053|P2|Participant Flow|Expectant (Usual) Management|Intervention at the discretion of the attending physician
444416|NCT00599053|P1|Participant Flow|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
444417|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
444418|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
444419|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
444420|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
444421|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
444422|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
444423|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
444424|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
444425|NCT00599053|E2|Reported Event|Expectant (Usual) Management|Intervention at the discretion of the attending physician
444426|NCT00599053|E1|Reported Event|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
444456|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control
Placebo: Placebo control (DMEM)"
444427|NCT00599131|B1|Baseline|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
444428|NCT00599131|P1|Participant Flow|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
444429|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
444430|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
444431|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
444432|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
444433|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
444434|NCT00599131|E1|Reported Event|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
444435|NCT00599196|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
444436|NCT00599196|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
444437|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
444438|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
444439|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
444440|NCT00599196|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
444441|NCT00599248|B3|Baseline|Total|Total of all reporting groups
444442|NCT00599248|B2|Baseline|Placebo Control (DMEM)|"Placebo control
Placebo: Placebo control (DMEM)"
444443|NCT00599248|B1|Baseline|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint
TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
444444|NCT00599248|P4|Participant Flow|Placebo Control (DMEM)|"Placebo Control (DMEM)
Placebo: Placebo control (DMEM) administered by a single intraarticular injection"
444445|NCT00599248|P3|Participant Flow|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint
TissueGene-C: TissueGene-C at 3x10e7 cells/joint administered by single intra-articular injection"
444446|NCT00599248|P2|Participant Flow|Active Treatment (TG-C) 2|"TissueGene-C at 1 x 10e7 cells/joint
TissueGene-C: TissueGene-C at 1x10e7 cells/joint administered by single intra-articular injection"
444447|NCT00599248|P1|Participant Flow|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint
TissueGene-C: TissueGene-C at 3x10e6 cells/joint administered by single intra-articular injection"
444448|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control
Placebo: Placebo control (DMEM)"
444449|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint
TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
444450|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint
TissueGene-C: TissueGene-C at 1x10e7 cells/joint to be administered by a single intra-articular injection"
444451|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint
TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
444452|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control
Placebo: Placebo control (DMEM)"
444453|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint
TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
444454|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint
TissueGene-C: TissueGene-C at 1x10e7 cells/joint to be administered by a single intra-articular injection"
444646|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444457|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint
TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
444458|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint
TissueGene-C: TissueGene-C at 1x10e7 cells/joint to be administered by a single intra-articular injection"
444459|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint
TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
444460|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control
Placebo: Placebo control (DMEM)"
444461|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint
TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
444462|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint
TissueGene-C: TissueGene-C at 1x10e7 cells/joint to be administered by a single intra-articular injection"
444463|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint
TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
444464|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control
Placebo: Placebo control (DMEM)"
444465|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint
TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
444466|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint
TissueGene-C: TissueGene-C at 1x10e7 cells/joint to be administered by a single intra-articular injection"
444467|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint
TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
444468|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control
Placebo: Placebo control (DMEM)"
444469|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint
TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
444470|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint
TissueGene-C: TissueGene-C at 1x107 cells/joint to be administered by a single intra-articular injection"
444471|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint
TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
444472|NCT00599248|E2|Reported Event|Placebo Control (DMEM)|"Placebo control
Placebo: Placebo control (DMEM)"
444473|NCT00599248|E1|Reported Event|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint
TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
444474|NCT00599313|B1|Baseline|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
444475|NCT00599313|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
444476|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
444477|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
444478|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
444479|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
444480|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
444481|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
444482|NCT00599313|E1|Reported Event|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
444483|NCT00599326|B1|Baseline|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
444484|NCT00599326|P1|Participant Flow|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
444485|NCT00599326|O1|Outcome|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
444486|NCT00599326|O1|Outcome|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
444487|NCT00599326|E1|Reported Event|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
444488|NCT00599339|B1|Baseline|Overall|For this study, 5 groups of patients with different Parkinson’s disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
444633|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444634|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444489|NCT00599339|P1|Participant Flow|Overall|For this study, 5 groups of patients with different Parkinson's disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
444490|NCT00599339|O2|Outcome|Not Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine.
An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE."
444647|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444491|NCT00599339|O1|Outcome|Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine.
An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. Associated Event does not necessarily mean related to treatment with Rotigotine."
444492|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444493|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444494|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444495|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444496|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444497|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444498|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444499|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444500|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444501|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444502|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444503|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444504|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444505|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444506|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444648|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444507|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444508|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444509|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444510|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444511|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444512|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444513|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444514|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444515|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444516|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444517|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444518|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444519|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444520|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444635|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444521|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444522|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444523|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444524|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444525|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444526|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444527|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444528|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444529|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444530|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444531|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444532|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444533|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444534|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444535|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444536|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444636|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444537|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444538|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444539|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444540|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444541|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444542|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444543|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444544|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444545|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444546|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444547|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444548|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444549|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444550|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444551|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444552|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444637|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444553|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444554|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444555|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444556|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444557|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444558|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444559|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444560|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444561|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444562|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444563|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444564|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444565|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444566|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444567|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444568|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444638|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444569|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444570|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444571|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444572|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444573|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily not treated at Baseline."
444574|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444575|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
444576|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444577|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
444578|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444579|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
444580|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444581|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
444582|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444583|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
444584|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444639|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444585|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
444586|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444587|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
444588|NCT00599339|E2|Reported Event|Not Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine.
An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE."
444589|NCT00599339|E1|Reported Event|Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine.
An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. Associated Event does not necessarily mean related to treatment with Rotigotine."
444590|NCT00599521|B3|Baseline|Total|Total of all reporting groups
444591|NCT00599521|B2|Baseline|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444592|NCT00599521|B1|Baseline|Adapalene Lotion 0.1%|once a day for 12 weeks
444593|NCT00599521|P2|Participant Flow|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444594|NCT00599521|P1|Participant Flow|Adapalene Lotion 0.1%|once a day for 12 weeks
444595|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444596|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
444597|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444598|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
444599|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444600|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
444601|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444602|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
444603|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444604|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
444605|NCT00599521|E2|Reported Event|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
444606|NCT00599521|E1|Reported Event|Adapalene Lotion 0.1%|once a day for 12 weeks
444607|NCT00590720|B3|Baseline|Total|Total of all reporting groups
444608|NCT00590720|B2|Baseline|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444609|NCT00590720|B1|Baseline|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444610|NCT00590720|P2|Participant Flow|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444611|NCT00590720|P1|Participant Flow|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444612|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444613|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444614|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444615|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444616|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444617|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444618|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444619|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444620|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444621|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444622|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444623|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444624|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444625|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444626|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444627|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444628|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444629|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444630|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444631|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444632|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444640|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444641|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444642|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444643|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444644|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
444645|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
444654|NCT00590759|O1|Outcome|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
444655|NCT00590759|O1|Outcome|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
444656|NCT00590759|E1|Reported Event|0502 TAG Device Subjects|
444657|NCT00590772|B1|Baseline|Group 1|cross over
444658|NCT00590772|P1|Participant Flow|Group 1|subjects were randomized to placebo or active drug and then cross over to opposite; however, the details of the randomization are no longer available.
444659|NCT00590772|O2|Outcome|Placebo|
444660|NCT00590772|O1|Outcome|Montelukast|
444661|NCT00590772|E2|Reported Event|Placebo|
444662|NCT00590772|E1|Reported Event|Montelukast|
444663|NCT00590863|B4|Baseline|Total|Total of all reporting groups
444664|NCT00590863|B3|Baseline|Escitalopram + Placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
444665|NCT00590863|B2|Baseline|Venlafaxine XR + Mirtazapine|Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
444666|NCT00590863|B1|Baseline|Escitalopram + Bupropion SR|Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
444667|NCT00590863|P3|Participant Flow|Escitalopram + Placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
444668|NCT00590863|P2|Participant Flow|Venlafaxine XR + Mirtazapine|Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
444669|NCT00590863|P1|Participant Flow|Escitalopram + Bupropion SR|Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
444670|NCT00590863|O3|Outcome|Escitalopram + Placebo|"Participants will take escitalopram plus placebo.
Escitalopram + placebo : Participants will take escitalopram plus placebo for up to 28 weeks."
444671|NCT00590863|O2|Outcome|Venlafaxine XR + Mirtazapine|Participants will take Venalfaxine XR + Mirtazapine for up to 28 weeks.
444672|NCT00590863|O1|Outcome|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
444673|NCT00590863|O3|Outcome|Escitalopram + Placebo|"Participants will take escitalopram plus placebo.
Escitalopram + placebo : Participants will take escitalopram plus placebo for up to 28 weeks."
444674|NCT00590863|O2|Outcome|Venlafaxine XR + Mirtazapine|Participants will take Venlafaine XR + Mirtazapine for up to 28 weeks.
444675|NCT00590863|O1|Outcome|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
444676|NCT00590863|E3|Reported Event|Escitalopram + Placebo|Participants will take Escitalopram + Placebo for up to 28 weeks.
444677|NCT00590863|E2|Reported Event|Venlafaxine XR + Mirtazapine|Participants will take Venlafaxine XR + Mirtazapine for up to 28 weeks.
444678|NCT00590863|E1|Reported Event|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
444679|NCT00590889|B3|Baseline|Total|Total of all reporting groups
444680|NCT00590889|B2|Baseline|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
444681|NCT00590889|B1|Baseline|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
444682|NCT00590889|P2|Participant Flow|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
444683|NCT00590889|P1|Participant Flow|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
444684|NCT00590889|O2|Outcome|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
445282|NCT00592488|B1|Baseline|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
444685|NCT00590889|O1|Outcome|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
444686|NCT00590889|E2|Reported Event|Adverse Events for the Silzone™ Group|These patients received the Silzone™ treated heart valve.
444687|NCT00590889|E1|Reported Event|Adverse Events for the Conventional Group|These patients received a conventional heart valve.
444688|NCT00590902|B1|Baseline|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
444689|NCT00590902|P1|Participant Flow|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
444690|NCT00590902|O1|Outcome|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
444691|NCT00590902|E1|Reported Event|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
444692|NCT00590967|B3|Baseline|Total|Total of all reporting groups
444693|NCT00590967|B2|Baseline|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444694|NCT00590967|B1|Baseline|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin 40 mg/m^2"
444695|NCT00590967|P2|Participant Flow|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444696|NCT00590967|P1|Participant Flow|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on fluorodeoxyglucose (FDG) positron emission tomography (PET).
Intensity-modulated radiation therapy (IMRT) External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 high dose radiation (HDR) treatments)
Weekly cisplatin 40 mg/m^2"
444697|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444698|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444699|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444700|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444701|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444702|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444703|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444704|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444705|NCT00590967|E2|Reported Event|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444706|NCT00590967|E1|Reported Event|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m^2)"
444707|NCT00591006|B1|Baseline|Total Study Population|Seventeen healthy controls, in a one-hour imaging session, received a structural MRI, MRS and fMRI scan four separate times with a 21 day washout between each study drug exposure in a crossover design. Prior to each scan each participant received placebo + placebo, phenytoin + placebo, hydrocortisone + placebo, or hydrocortisone + phenytoin in a random fashion. Thus, each participant received each of the four possible study drug combinations in a random order with an extended drug washout between each exposure. Hippocampal activation, volume and biochemistry, as well as mood and memory was assessed.
444708|NCT00591006|P24|Participant Flow|PH + PL Then PL + H Then PL + PL Then PH + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
444793|NCT00591253|B2|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444709|NCT00591006|P23|Participant Flow|PL + PL Then PH + H Then PL + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
444744|NCT00591006|E4|Reported Event|Placebo, Then Placebo|"Hydrocortisone, Phenytoin
Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
444768|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
444710|NCT00591006|P22|Participant Flow|PL + PL Then PL + H Then PH + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
444711|NCT00591006|P21|Participant Flow|PL + PL Then PL + H Then PH + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
444712|NCT00591006|P20|Participant Flow|PL + PL Then PH + H Then PH + PL Then PL + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
444713|NCT00591006|P19|Participant Flow|PL + PL Then PH + PL Then PL + H Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
444714|NCT00591006|P18|Participant Flow|PH + PL Then PH + H Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
444715|NCT00591006|P17|Participant Flow|PH + PL Then PH + H Then PL + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
444787|NCT00591240|O2|Outcome|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
444794|NCT00591253|B1|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444745|NCT00591006|E3|Reported Event|Placebo, Then Hydrocortisone|"Hydrocortisone, Placebo
Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
444769|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
444770|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
444716|NCT00591006|P16|Participant Flow|PH + PL Then PL + PL Then PL + H Then PH + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
444717|NCT00591006|P15|Participant Flow|PH + PL Then PL + PL Then PH + H Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
444718|NCT00591006|P14|Participant Flow|PH + H Then PL + PL Then PL + H Then PH + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
444719|NCT00591006|P13|Participant Flow|PH + H Then PL + PL Then PH + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
444720|NCT00591006|P12|Participant Flow|PH + H Then PH + PL Then PL + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
444721|NCT00591006|P11|Participant Flow|PH + H Then PL + H Then PH + PL Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
444722|NCT00591006|P10|Participant Flow|PH + H Then PL + H Then PL + PL Then PH + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
444788|NCT00591240|O1|Outcome|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
444795|NCT00591253|P3|Participant Flow|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444723|NCT00591006|P9|Participant Flow|PL + H Then PH + PL Then PH + H Then PL + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
444724|NCT00591006|P8|Participant Flow|PL + H Then PH + H Then PL + PL Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
444725|NCT00591006|P7|Participant Flow|PL + H Then PH +H Then PH + PL Then PL + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
444726|NCT00591006|P6|Participant Flow|PL + H Then PL + PL Then PH + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
444727|NCT00591006|P5|Participant Flow|PL + H Then PH + PL Then PL + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
444728|NCT00591006|P4|Participant Flow|PL + H Then PL + PL Then PH + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours (20mg) and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
444729|NCT00591006|P3|Participant Flow|PL + PL Then PH + PL Then PH + H Then PL + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
444789|NCT00591240|E2|Reported Event|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
446017|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
444730|NCT00591006|P2|Participant Flow|PH + H Then PH + PL Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
444731|NCT00591006|P1|Participant Flow|PH + PL Then PL + H Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by hydrocortisone (160 mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
444732|NCT00591006|O4|Outcome|PBO&Hydrocortisone|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
444733|NCT00591006|O3|Outcome|Phenytoin&PBO|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
444734|NCT00591006|O2|Outcome|PBO&PBO|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
444735|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
444736|NCT00591006|O4|Outcome|PBO&Hydrocortisone|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
444737|NCT00591006|O3|Outcome|Phenytoin&PBO|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
444738|NCT00591006|O2|Outcome|PBO&PBO|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets of placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
444739|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
444740|NCT00591006|O4|Outcome|Placebo&Hydrocortisone|Examining all participants for the condition in which they took placebo and hydrocortisone.
444741|NCT00591006|O3|Outcome|Phenytoin&Placebo|Examining all participants for the condition in which they took phenytoin and placebo.
444742|NCT00591006|O2|Outcome|Placebo&Placebo|Examining all participants for the condition in which they took placebo for both administrations.
444743|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Examining all participants for the condition in which they took both phenytoin and hydrocortisone.
444796|NCT00591253|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444797|NCT00591253|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
446018|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
444746|NCT00591006|E2|Reported Event|Phenytoin, Then Placebo|"Phenytoin, Placebo
Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
444747|NCT00591006|E1|Reported Event|Phenytoin, Then Hydrocortisone|"Placebo, Placebo
Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
444748|NCT00591019|B1|Baseline|All Participants|Subjects were tested at baseline, then entered either the modafinil or placebo condtion and then the remaining condition.
444749|NCT00591019|P2|Participant Flow|Baseline, Placebo, Modafinil 200 mg/Day|Subjects are tested after baseline, then after taking a sugar pill once per day in the morning for 14 days, and then after taking modafinil 200 mg/day for 14 days.
444750|NCT00591019|P1|Participant Flow|Baseline, Modafinil 200 mg/Day, Placebo|Subjects are tested at baseline, then after Modafinil (200mg/day, a.m. administration) for 14 days, then after placebo (for 14 days).
444751|NCT00591019|O3|Outcome|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
444752|NCT00591019|O2|Outcome|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
444753|NCT00591019|O1|Outcome|Baseline Testing.|Establish baseline levels of performance
444754|NCT00591019|O3|Outcome|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
444755|NCT00591019|O2|Outcome|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
444756|NCT00591019|O1|Outcome|Baseline Testing.|Establish baseline levels of performance
444757|NCT00591019|E3|Reported Event|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
444758|NCT00591019|E2|Reported Event|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
444759|NCT00591019|E1|Reported Event|Baseline Testing.|Establish baseline levels of performance
444760|NCT00591149|B1|Baseline|Oxalipatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks"
444761|NCT00591149|P1|Participant Flow|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles"
444762|NCT00591149|O1|Outcome|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks"
444790|NCT00591240|E1|Reported Event|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
444763|NCT00591149|E1|Reported Event|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles"
444764|NCT00591214|B1|Baseline|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
444765|NCT00591214|P1|Participant Flow|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
444766|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
444767|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
444771|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
444772|NCT00591214|E1|Reported Event|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
444773|NCT00591227|B3|Baseline|Total|Total of all reporting groups
444774|NCT00591227|B2|Baseline|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
444775|NCT00591227|B1|Baseline|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
444776|NCT00591227|P2|Participant Flow|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
444777|NCT00591227|P1|Participant Flow|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
444778|NCT00591227|O2|Outcome|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
444779|NCT00591227|O1|Outcome|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
444780|NCT00591227|E2|Reported Event|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
444781|NCT00591227|E1|Reported Event|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
444782|NCT00591240|B3|Baseline|Total|Total of all reporting groups
444783|NCT00591240|B2|Baseline|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
444784|NCT00591240|B1|Baseline|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
444785|NCT00591240|P2|Participant Flow|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
444786|NCT00591240|P1|Participant Flow|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
444791|NCT00591253|B4|Baseline|Total|Total of all reporting groups
444792|NCT00591253|B3|Baseline|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444798|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444799|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444800|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444801|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444802|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444803|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444804|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444805|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444806|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444807|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444808|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444931|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
444809|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444810|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444811|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444812|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444813|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444814|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444815|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444816|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444817|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444818|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444819|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444820|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444821|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444822|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444823|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444824|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444825|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444826|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444827|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444828|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444829|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444830|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444831|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444832|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444833|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444834|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444835|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444836|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444837|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444838|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444839|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444840|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444841|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444842|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444843|NCT00591253|E3|Reported Event|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
444844|NCT00591253|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
444845|NCT00591253|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
444846|NCT00591266|B4|Baseline|Total|Total of all reporting groups
444847|NCT00591266|B3|Baseline|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
445100|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants with phobia were given one administration 100 mg placebo.
444848|NCT00591266|B2|Baseline|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444849|NCT00591266|B1|Baseline|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444850|NCT00591266|P3|Participant Flow|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444851|NCT00591266|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444852|NCT00591266|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444853|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444854|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444855|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444856|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444857|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444858|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444859|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444860|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444861|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444862|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444863|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444864|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444865|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444866|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444867|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444868|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444869|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444870|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444871|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444872|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444873|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444874|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444875|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444876|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444877|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444878|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444879|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444880|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444881|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444882|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444883|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444884|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444885|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444886|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444887|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444888|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444889|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444890|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444891|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444892|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444893|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444894|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444895|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444932|NCT00591370|E1|Reported Event|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
444896|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444897|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444898|NCT00591266|E3|Reported Event|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444899|NCT00591266|E2|Reported Event|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444900|NCT00591266|E1|Reported Event|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
444901|NCT00591305|B3|Baseline|Total|Total of all reporting groups
444902|NCT00591305|B2|Baseline|PDL+Placebo Pill|"once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects
585 nm pulsed dye laser: once-time PDL"
444903|NCT00591305|B1|Baseline|PDL+DIM Pill|"once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects
diindolylmethane (DIM): 3-month DIM
585 nm pulsed dye laser: once-time PDL"
444904|NCT00591305|P2|Participant Flow|PDL+Placebo Pill|"once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects
585 nm pulsed dye laser: once-time PDL"
444905|NCT00591305|P1|Participant Flow|PDL+DIM Pill|"once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects
diindolylmethane (DIM): 3-month DIM
585 nm pulsed dye laser: once-time PDL"
444906|NCT00591305|O2|Outcome|Placebo|laser only without DIM
444907|NCT00591305|O1|Outcome|Intervention|laser+diatary DIM
444908|NCT00591305|O2|Outcome|Placebo|laser only without DIM
444909|NCT00591305|O1|Outcome|Intervention|laser+diatary DIM
444910|NCT00591305|O2|Outcome|Placebo|laser only without DIM
444911|NCT00591305|O1|Outcome|Intervention|laser+dietary DIM
444912|NCT00591305|E2|Reported Event|PDL+Placebo Pill|once-time PDL treatment by PDL on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects
444913|NCT00591305|E1|Reported Event|PDL+DIM Pill|once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects
444914|NCT00591344|B3|Baseline|Total|Total of all reporting groups
444915|NCT00591344|B2|Baseline|2 Flexibility Training|"25 PD subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.
Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
444916|NCT00591344|B1|Baseline|1 Progressive Resistance Training|"25 PD Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.
Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
444917|NCT00591344|P2|Participant Flow|2 Modified Fitness Counts|"Subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.
Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
444918|NCT00591344|P1|Participant Flow|1 Progressive Resistance Training|"Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.
Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
444919|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment- L-dopa equilivent-mg/day
444920|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- L-dopa equilivent-mg/day
444921|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment - on medication UPDRS part III, motor subscale score
444922|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- on medication UPDRS part III, motor subscale score
444923|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment - off medication UPDRS part III, motor subscale score
444924|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- off medication UPDRS part III, motor subscale score
445101|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia were given one administration placebo.
444925|NCT00591344|E2|Reported Event|2 Modified Fitness Counts|"Subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.
Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
444926|NCT00591344|E1|Reported Event|1 Progressive Resistance Training|"Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.
Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
444927|NCT00591370|B1|Baseline|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
444928|NCT00591370|P1|Participant Flow|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
444929|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
444930|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
444938|NCT00591578|B3|Baseline|Valsartan 320 mg QD|"Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
444939|NCT00591578|B2|Baseline|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).
Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
444940|NCT00591578|B1|Baseline|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).
Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
444941|NCT00591578|P3|Participant Flow|Valsartan 320 mg QD|"Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
444942|NCT00591578|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
444943|NCT00591578|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
444944|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444945|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
446117|NCT00603187|P1|Participant Flow|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
444946|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444947|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444948|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444949|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444950|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444951|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444952|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444953|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444954|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444955|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444956|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444957|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444958|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444959|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444960|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444961|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444962|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444963|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444964|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444965|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444966|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444967|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444968|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444969|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444970|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444971|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444972|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444973|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444974|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444975|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444976|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444977|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444978|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444979|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444980|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444981|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444982|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444983|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444984|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444985|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444986|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
444987|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
444988|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
444989|NCT00591578|E4|Reported Event|Open Label Extension|Azilsartan medoxomil 40 mg, tablets, orally, independent of participant’s double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).
444990|NCT00591578|E3|Reported Event|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
445114|NCT00591825|O2|Outcome|DCS Control|Participants without phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).
444991|NCT00591578|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
444992|NCT00591578|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
444993|NCT00591591|B3|Baseline|Total|Total of all reporting groups
444994|NCT00591591|B2|Baseline|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
444995|NCT00591591|B1|Baseline|Controls|Healthy controls
444996|NCT00591591|P2|Participant Flow|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
444997|NCT00591591|P1|Participant Flow|Controls|Healthy controls
444998|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
444999|NCT00591591|O1|Outcome|Controls|Healthy controls
445000|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
445001|NCT00591591|O1|Outcome|Controls|Healthy controls
445002|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
445003|NCT00591591|O1|Outcome|Controls|Healthy controls
445004|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
445005|NCT00591591|O1|Outcome|Controls|Healthy controls
445006|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
445007|NCT00591591|O1|Outcome|Controls|Healthy controls
445008|NCT00591591|E2|Reported Event|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
445009|NCT00591591|E1|Reported Event|Controls|Healthy controls
445010|NCT00591721|B3|Baseline|Total|Total of all reporting groups
445011|NCT00591721|B2|Baseline|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
445012|NCT00591721|B1|Baseline|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
445013|NCT00591721|P2|Participant Flow|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
445014|NCT00591721|P1|Participant Flow|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
445015|NCT00591721|O2|Outcome|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
445016|NCT00591721|O1|Outcome|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
445017|NCT00591721|E2|Reported Event|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
445018|NCT00591721|E1|Reported Event|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
445019|NCT00591734|B1|Baseline|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
445227|NCT00592319|B1|Baseline|Control|"treated with routine surgery (CO2 laser or cold microsurgery), in 15 cases"
445020|NCT00591734|P1|Participant Flow|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
445021|NCT00591734|O1|Outcome|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
445022|NCT00591734|E1|Reported Event|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
445023|NCT00591760|B3|Baseline|Total|Total of all reporting groups
445024|NCT00591760|B2|Baseline|Control|Optimal CHF treatment
445025|NCT00591760|B1|Baseline|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
445026|NCT00591760|P2|Participant Flow|Control|Optimal CHF treatment
445027|NCT00591760|P1|Participant Flow|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
445028|NCT00591760|O2|Outcome|Control|Optimal CHF treatment
445029|NCT00591760|O1|Outcome|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
445031|NCT00591760|E1|Reported Event|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
445032|NCT00591773|B4|Baseline|Total|Total of all reporting groups
445033|NCT00591773|B3|Baseline|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445034|NCT00591773|B2|Baseline|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445035|NCT00591773|B1|Baseline|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445036|NCT00591773|P3|Participant Flow|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445037|NCT00591773|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445038|NCT00591773|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445039|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445040|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445041|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445042|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445043|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445044|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445045|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445046|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445047|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445048|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445049|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445050|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445051|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445052|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445053|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445054|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445055|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445056|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445057|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445058|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
446791|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
445059|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445060|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445061|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445062|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445063|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445064|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445065|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445066|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445067|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445298|NCT00592683|B3|Baseline|Total|Total of all reporting groups
445068|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445069|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445070|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445071|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445072|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445073|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445074|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445075|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445076|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445077|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445078|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445079|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445080|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445081|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445082|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445083|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445084|NCT00591773|E3|Reported Event|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445085|NCT00591773|E2|Reported Event|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445086|NCT00591773|E1|Reported Event|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
445087|NCT00591825|B5|Baseline|Total|Total of all reporting groups
445088|NCT00591825|B4|Baseline|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
445089|NCT00591825|B3|Baseline|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
445090|NCT00591825|B2|Baseline|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
445091|NCT00591825|B1|Baseline|Non-Phobic Control - Placebo|Participants without phobia given one administration of placebo.
445092|NCT00591825|P4|Participant Flow|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
445093|NCT00591825|P3|Participant Flow|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
445094|NCT00591825|P2|Participant Flow|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
445095|NCT00591825|P1|Participant Flow|Non-Phobic Control - Placebo|Participants without phobia given one administration placebo.
445096|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants with phobia were given one administration 100 mg D-cycloserine (DCS).
445097|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia were given one administration placebo.
445098|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia were given one administration 100 mg D-cycloserine (DCS).
445099|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia were given one administration placebo.
445102|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia were given one administration 100 mg D-cycloserine (DCS).
445103|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia were given one administration placebo.
445104|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
445105|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
445106|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
445107|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia given one administration of placebo.
445108|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants without phobia given one administration of 100 mg D-cycloserine.
445109|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
445110|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
445111|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia given one administration of placebo.
445112|NCT00591825|O4|Outcome|Placebo Control|Participants without phobia who were randomized to the Placebo group were given one administration of placebo.
445113|NCT00591825|O3|Outcome|Placebo Phobic|Participants with phobia who were randomized to the Placebo group were given one administration of placebo.
445115|NCT00591825|O1|Outcome|DCS Phobic|Participants with phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).
445116|NCT00591825|E4|Reported Event|Spider-phobic DCS|Participants with phobia were given one administration 100 mg D-cycloserine (DCS).
445117|NCT00591825|E3|Reported Event|Spider-phobic Placebo|Participants with phobia were given one administration placebo.
445118|NCT00591825|E2|Reported Event|Non-Phobic Control - DCS|Participants without phobia were given one administration 100 mg D-cycloserine (DCS).
445119|NCT00591825|E1|Reported Event|Non-Phobic Control - Placebo|Participants without phobia were given one administration placebo.
445120|NCT00591851|B1|Baseline|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
445121|NCT00591851|P1|Participant Flow|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
445122|NCT00591851|O1|Outcome|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
445123|NCT00591851|E1|Reported Event|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
445124|NCT00591864|B1|Baseline|Study Participants|There are no arms or subgroups in this study.
445125|NCT00591864|P1|Participant Flow|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
445126|NCT00591864|O1|Outcome|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
445127|NCT00591864|O1|Outcome|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
445128|NCT00591864|O1|Outcome|Study Participants|There are no arms or subgroups in this study.
445129|NCT00591864|E1|Reported Event|Study Participants|There are no arms or subgroups in this study.
445130|NCT00592007|B1|Baseline|Fulvestrant and Erlotinib|"Single-arm study
Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
445131|NCT00592007|P1|Participant Flow|Fulvestrand and Erlotinib|"Single-arm study
Fulvestrant and Erlotinib : Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
445132|NCT00592007|O1|Outcome|Arm A|"Single-arm study
Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
445133|NCT00592007|O1|Outcome|Arm A|"Single-arm study
Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
445134|NCT00592007|E1|Reported Event|A: Fulvestrant and Erlotinib|"Single-arm study
Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
445228|NCT00592319|P2|Participant Flow|Experimental|once-time PDL surgery at 6.0-8.0 W, followed by oral taking of Celecoxib (100mg,BID)for 9 months
445135|NCT00592072|B1|Baseline|Overall Number of Subjects|12 subjects started the study and 10 completed the study, however 11 subjects are reported in the baseline characteristics because one subjects withdrew before baseline data was collected.
445136|NCT00592072|P2|Participant Flow|Placebo Intervention First, Then MCT Intervention|A total of 40 grams of cherry-flavored water sweetened with sucralose is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice
445137|NCT00592072|P1|Participant Flow|MCT Intervention First, Then Placebo|A total of 40 grams of medium-chain triglycerides (derived from coconut oil containing 67% octanoate, 27% decanaote, and 6% other fatty acids) is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice
445138|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
445139|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
445140|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
445141|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
445142|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
445143|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
445144|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
445145|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
445146|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
445147|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
445148|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
445149|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
445150|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
445151|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
445152|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
445153|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
445154|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
445155|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
445156|NCT00592072|E2|Reported Event|Placebo Intervention|
445157|NCT00592072|E1|Reported Event|MCT Intervention|
445158|NCT00592124|B7|Baseline|Total|Total of all reporting groups
445159|NCT00592124|B6|Baseline|V, OV, O|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
445160|NCT00592124|B5|Baseline|O, OV, V|"Oral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
445161|NCT00592124|B4|Baseline|OV, V, O|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
445162|NCT00592124|B3|Baseline|OV, O, V|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
445163|NCT00592124|B2|Baseline|V, O, OV|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
445164|NCT00592124|B1|Baseline|O, V, OV|"Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
445165|NCT00592124|P6|Participant Flow|V, OV, O|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
445166|NCT00592124|P5|Participant Flow|O, OV, V|"Oral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
445167|NCT00592124|P4|Participant Flow|OV, V, O|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
445168|NCT00592124|P3|Participant Flow|OV, O, V|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
445169|NCT00592124|P2|Participant Flow|V, O, OV|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
446792|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
445170|NCT00592124|P1|Participant Flow|O, V, OV|"Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
445171|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445172|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445173|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445174|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445175|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445176|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
445177|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445178|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445179|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445180|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445181|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445182|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445183|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445184|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445185|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445186|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445187|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445188|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445189|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445190|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445191|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445192|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445193|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445194|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445195|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445196|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445197|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445198|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445199|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445200|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445201|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445202|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445203|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445204|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445205|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445206|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445207|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445208|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445209|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445210|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
445211|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445212|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445213|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
445214|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445215|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445216|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
445217|NCT00592124|E3|Reported Event|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
445218|NCT00592124|E2|Reported Event|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
445219|NCT00592124|E1|Reported Event|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
445220|NCT00592176|B1|Baseline|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
445221|NCT00592176|P1|Participant Flow|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
445222|NCT00592176|O1|Outcome|Bevacizumab|Patients receiving bevacizumab treatment.
445223|NCT00592176|O1|Outcome|Bevacizumab|Patients receiving bevacizumab treatment.
445224|NCT00592176|E1|Reported Event|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
445225|NCT00592319|B3|Baseline|Total|Total of all reporting groups
445226|NCT00592319|B2|Baseline|Experimental|treated with once-time PDL, followed by oral taking of 9-month Celecoxib, in 15 cases
445229|NCT00592319|P1|Participant Flow|Control|"once-time routine surgery with (either of CO2 laser at continue model and 10.0-20.0 W, or cold surgery with micro-instruments), in 15 subjects"
445230|NCT00592319|O2|Outcome|Experienment|treated with once-time PDL, followed by oral taking of Celebrex (100mg,BID) for 9 months
445231|NCT00592319|O1|Outcome|Control|"treated with once-time routine surgery (CO2 laser or cold microsurgery)"
445232|NCT00592319|O2|Outcome|Experiment|treated with both of once-time PDL and 9-month Celebrex
445233|NCT00592319|O1|Outcome|Control|treated with once-time routine surgery
445234|NCT00592319|E2|Reported Event|Control|treatd with CO2 laser or microsurgery
445235|NCT00592319|E1|Reported Event|Experiment|treated with both of PDL and Celecoxib
445236|NCT00592358|B1|Baseline|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
445237|NCT00592358|P1|Participant Flow|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
445238|NCT00592358|O1|Outcome|Paliperidone|Open-label treatment with Paliperidone.
445239|NCT00592358|O1|Outcome|Paliperidone|Open-label treatment with Paliperidone.
445240|NCT00592358|E1|Reported Event|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
445241|NCT00592384|B3|Baseline|Total|Total of all reporting groups
445242|NCT00592384|B2|Baseline|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
445243|NCT00592384|B1|Baseline|Placebo Control|placebo: identically encapsulated inactive substance
445244|NCT00592384|P2|Participant Flow|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
445245|NCT00592384|P1|Participant Flow|Placebo Control|placebo: identically encapsulated inactive substance
445246|NCT00592384|O2|Outcome|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
445247|NCT00592384|O1|Outcome|Placebo Control|placebo: identically encapsulated inactive substance
445248|NCT00592384|O2|Outcome|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
445249|NCT00592384|O1|Outcome|Placebo Control|placebo: identically encapsulated inactive substance
445250|NCT00592384|E2|Reported Event|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
445251|NCT00592384|E1|Reported Event|Placebo Control|placebo: identically encapsulated inactive substance
445252|NCT00592475|B4|Baseline|Total|Total of all reporting groups
445253|NCT00592475|B3|Baseline|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
445254|NCT00592475|B2|Baseline|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
445255|NCT00592475|B1|Baseline|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
445256|NCT00592475|P3|Participant Flow|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
445257|NCT00592475|P2|Participant Flow|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
445258|NCT00592475|P1|Participant Flow|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
445259|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
445260|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
445261|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
445262|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
445263|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
445264|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
445265|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
445266|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
445267|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
445268|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
445269|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
445270|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
445271|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
445272|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
445273|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
445274|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
445275|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
445276|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
445277|NCT00592475|E3|Reported Event|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
445278|NCT00592475|E2|Reported Event|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
445279|NCT00592475|E1|Reported Event|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
445280|NCT00592488|B3|Baseline|Total|Total of all reporting groups
445281|NCT00592488|B2|Baseline|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
445283|NCT00592488|P2|Participant Flow|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
445284|NCT00592488|P1|Participant Flow|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
445285|NCT00592488|O2|Outcome|Placebo Then Acetyl-L-Carnitine (ALC)|Placebo for hours 0-6 then ALC for hours 6-18
445286|NCT00592488|O1|Outcome|Acetyl-L-Carnitine (ALC) Then Placebo|ALC for hours 0-12 and placebo hours 12-18
445287|NCT00592488|E2|Reported Event|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
445288|NCT00592488|E1|Reported Event|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
445289|NCT00592631|B3|Baseline|Total|Total of all reporting groups
445290|NCT00592631|B2|Baseline|Sham|Subjects used SHAM set at 0-2 cmH20 for 7-10 nights
445291|NCT00592631|B1|Baseline|CPAP|Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
445292|NCT00592631|P2|Participant Flow|Sham Treatment|Adults with stable asthma and normal spirometry used SHAM with a mask pressure Mask pressure between 0 and 2 cm H20 for 7 to 10 nights prior to the follow-up assessment.
445293|NCT00592631|P1|Participant Flow|Continuous Positivie Airway Pressure|Adult with stable asthma and normal spirometry used CPAP with a mask pressure between 8 and 10 cm H20 for 7 to 10 nights prior to the follow-up assessment.
445294|NCT00592631|O2|Outcome|Sham|Subjects used sham set at 0-2 cmH20 for 7-10 nights
445295|NCT00592631|O1|Outcome|CPAP|Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
445296|NCT00592631|E2|Reported Event|Sham|
445297|NCT00592631|E1|Reported Event|Continuous Positive Airway Pressure|
445299|NCT00592683|B2|Baseline|Aripiprazole + Placebo|treatment with aripiprazole + placebo
445300|NCT00592683|B1|Baseline|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
445301|NCT00592683|P2|Participant Flow|Aripiprazole + Placebo|treatment with aripiprazole + placebo
445302|NCT00592683|P1|Participant Flow|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
445303|NCT00592683|O2|Outcome|Aripiprazole + Placebo|treatment with aripiprazole + placebo
445304|NCT00592683|O1|Outcome|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
445305|NCT00592683|O2|Outcome|Aripiprazole + Placebo|treatment with aripiprazole + placebo
445306|NCT00592683|O1|Outcome|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
445307|NCT00592683|E2|Reported Event|Aripiprazole + Placebo|treatment with aripiprazole + placebo
445308|NCT00592683|E1|Reported Event|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
445309|NCT00592761|B1|Baseline|Entire Study Population|This includes all participants. Half received treatment then no treatment and have received no treatment then treatment.
445310|NCT00592761|P2|Participant Flow|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
445311|NCT00592761|P1|Participant Flow|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
445312|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
445313|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
445314|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
445315|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
445316|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
445317|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
445318|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
445319|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
445320|NCT00592761|E2|Reported Event|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
445321|NCT00592761|E1|Reported Event|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
445322|NCT00592774|B6|Baseline|Total|Total of all reporting groups
445323|NCT00592774|B5|Baseline|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445324|NCT00592774|B4|Baseline|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445325|NCT00592774|B3|Baseline|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445326|NCT00592774|B2|Baseline|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445327|NCT00592774|B1|Baseline|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445328|NCT00592774|P5|Participant Flow|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445329|NCT00592774|P4|Participant Flow|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445330|NCT00592774|P3|Participant Flow|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445331|NCT00592774|P2|Participant Flow|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445332|NCT00592774|P1|Participant Flow|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445333|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445334|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445335|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445336|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445337|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445338|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445339|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445340|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445341|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445342|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445343|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445344|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445345|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445346|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445347|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445348|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445349|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445350|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445351|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445352|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445353|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445354|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445355|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445356|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445500|NCT00599872|O2|Outcome|Placebo|"Standardized Ragweed Allergenic Extract Placebo via the sublingual oral route
Placebo: Placebo, sublingual oral"
445357|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445358|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445359|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445360|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445361|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445362|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445363|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445398|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
445364|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445365|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445366|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445367|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445368|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445369|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445370|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445371|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445372|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445373|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445374|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445375|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445376|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445377|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445378|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445379|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445380|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445381|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445382|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445383|NCT00592774|E5|Reported Event|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445384|NCT00592774|E4|Reported Event|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
445385|NCT00592774|E3|Reported Event|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445386|NCT00592774|E2|Reported Event|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
445387|NCT00592774|E1|Reported Event|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
445388|NCT00592839|B4|Baseline|Total|Total of all reporting groups
445389|NCT00592839|B3|Baseline|Placebo Daily|Placebo tablet daily orally
445390|NCT00592839|B2|Baseline|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
445391|NCT00592839|B1|Baseline|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
445392|NCT00592839|P3|Participant Flow|Placebo Daily|Placebo tablet daily orally
445393|NCT00592839|P2|Participant Flow|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
445394|NCT00592839|P1|Participant Flow|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
445395|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
445396|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
445397|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
445399|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
445400|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
445401|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
445402|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
445403|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
445404|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
445405|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
445406|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
445407|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
445408|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
445409|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
445410|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
445411|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
445412|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
445413|NCT00592839|E3|Reported Event|Placebo Daily|Placebo tablet daily orally
445414|NCT00592839|E2|Reported Event|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
445415|NCT00592839|E1|Reported Event|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
445416|NCT00592852|B1|Baseline|Fluoxetine|
445417|NCT00592852|P1|Participant Flow|Fluoxetine|
445418|NCT00592852|O1|Outcome|Fluoxetine|
445419|NCT00592852|O1|Outcome|Fluoxetine|
445420|NCT00592852|E1|Reported Event|Fluoxetine|
445421|NCT00592904|B5|Baseline|Total|Total of all reporting groups
445422|NCT00592904|B4|Baseline|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445423|NCT00592904|B3|Baseline|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445424|NCT00592904|B2|Baseline|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445425|NCT00592904|B1|Baseline|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445426|NCT00592904|P4|Participant Flow|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445427|NCT00592904|P3|Participant Flow|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445428|NCT00592904|P2|Participant Flow|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445429|NCT00592904|P1|Participant Flow|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445533|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445430|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445431|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445432|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445433|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445434|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445435|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445436|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445437|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445438|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445439|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445440|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445441|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445442|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445443|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445444|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445445|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445446|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445447|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445448|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445449|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
445450|NCT00592904|E4|Reported Event|Post Herpetic Neuralgia|The participants that were being treated for PHN in the double-blind study and received either placebo or perampanel.
445451|NCT00592904|E3|Reported Event|Painful Diabetic Neuropathy|The participants that were being treated for PDN in the double-blind study and received either placebo or perampanel.
445452|NCT00592904|E2|Reported Event|Perampanel|The participants that had previously received perampanel during the double-blind study.
445453|NCT00592904|E1|Reported Event|Placebo|The participants who had previously received placebo during the double-blind study.
445454|NCT00592943|B3|Baseline|Total|Total of all reporting groups
445455|NCT00592943|B2|Baseline|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
445456|NCT00592943|B1|Baseline|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
445457|NCT00592943|P2|Participant Flow|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
445458|NCT00592943|P1|Participant Flow|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
445459|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
445460|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
445461|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
445462|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
445463|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
445464|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
445465|NCT00592943|E2|Reported Event|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
445466|NCT00592943|E1|Reported Event|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
445467|NCT00593112|B3|Baseline|Total|Total of all reporting groups
445468|NCT00593112|B2|Baseline|Control|Healthy Volunteer Control group
445469|NCT00593112|B1|Baseline|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
445470|NCT00593112|P2|Participant Flow|Control|Healthy Volunteer Control group
445471|NCT00593112|P1|Participant Flow|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
445472|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
445473|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
445474|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
445475|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
445476|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
445477|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
445478|NCT00593112|E2|Reported Event|Control|Healthy Volunteer Control group
445479|NCT00593112|E1|Reported Event|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
445480|NCT00599755|B1|Baseline|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
445481|NCT00599755|P1|Participant Flow|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
445482|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
445483|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
445484|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
445485|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
445486|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
445487|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
445488|NCT00599755|E1|Reported Event|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
445489|NCT00599872|B3|Baseline|Total|Total of all reporting groups
445490|NCT00599872|B2|Baseline|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
445491|NCT00599872|B1|Baseline|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
445492|NCT00599872|P2|Participant Flow|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
445493|NCT00599872|P1|Participant Flow|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
445494|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
445495|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
445496|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
445497|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
445498|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
445499|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
445501|NCT00599872|O1|Outcome|Ragweed Allergenic Extract|"Standardized Ragweed Allergenic Extract administered via the sublingual oral route (27.6 to 77.3 Amb a 1 Units)
Standardized Ragweed Allergenic Extract: Standardized Ragweed Allergenic Extract, sublingual oral"
445502|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
445503|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
445504|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
445505|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 26.3 to 77.3 Units/Amb a 1.
445506|NCT00599872|E2|Reported Event|Placebo|Placebo be administered once daily at 0.0 Units/Amb a 1
445507|NCT00599872|E1|Reported Event|Ragweed Allergenic Extract|Ragweed Allergenic extract administered once daily at 77.3 Units/Amb a 1.
445508|NCT00599924|B8|Baseline|Total|Total of all reporting groups
445509|NCT00599924|B7|Baseline|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
445510|NCT00599924|B6|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
445511|NCT00599924|B5|Baseline|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
445709|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445512|NCT00599924|B4|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
445513|NCT00599924|B3|Baseline|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445514|NCT00599924|B2|Baseline|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445515|NCT00599924|B1|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445516|NCT00599924|P7|Participant Flow|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
445517|NCT00599924|P6|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
445518|NCT00599924|P5|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
445519|NCT00599924|P4|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
445520|NCT00599924|P3|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445521|NCT00599924|P2|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445522|NCT00599924|P1|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445523|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
445524|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
445525|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445526|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445527|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445528|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
445529|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
445530|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445531|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445532|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445638|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445639|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445534|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445535|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445536|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445537|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445538|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445539|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445540|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
446024|NCT00602537|P2|Participant Flow|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
445541|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445542|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445543|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445544|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445545|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445546|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445547|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445548|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445549|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445550|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445551|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445552|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445553|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445554|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445555|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445556|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445557|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445558|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445559|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445560|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445561|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445562|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445640|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445563|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445564|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445565|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445566|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445567|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445568|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445569|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445570|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445571|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445572|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445573|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445574|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445575|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445576|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445577|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445578|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445579|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445580|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445581|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445582|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445583|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445584|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445585|NCT00599924|O7|Outcome|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
445586|NCT00599924|O6|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
445587|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
445588|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
445589|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445590|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445591|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445641|NCT00601250|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445592|NCT00599924|O7|Outcome|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
445593|NCT00599924|O6|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
445594|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
445595|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
445596|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445597|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445598|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445599|NCT00599924|E7|Reported Event|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
445600|NCT00599924|E6|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
445601|NCT00599924|E5|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
445602|NCT00599924|E4|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
445603|NCT00599924|E3|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445604|NCT00599924|E2|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445605|NCT00599924|E1|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
445606|NCT00601250|B3|Baseline|Total|Total of all reporting groups
445607|NCT00601250|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445608|NCT00601250|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
445609|NCT00601250|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445610|NCT00601250|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
445611|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445612|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445613|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445614|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445615|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445616|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445617|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445618|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445619|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445620|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445621|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445622|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445623|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445624|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445625|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445626|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445627|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445628|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445629|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445630|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445631|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445632|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445633|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445634|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445635|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445636|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445637|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
445642|NCT00601250|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
445643|NCT00601354|B3|Baseline|Total|Total of all reporting groups
445644|NCT00601354|B2|Baseline|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
445645|NCT00601354|B1|Baseline|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
445646|NCT00601354|P2|Participant Flow|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
445647|NCT00601354|P1|Participant Flow|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
445648|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
445649|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
445650|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
445651|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
445652|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
445653|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
445654|NCT00601354|E2|Reported Event|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
445655|NCT00601354|E1|Reported Event|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
445656|NCT00601367|B1|Baseline|Flibanserin Flexible Dose|"Initial dosage:
Patients were to take one 50 mg flibanserin tablet in the evening.
Subsequent dosage titrations:
Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.
Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site.
flibanserin flexible dose: Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening.
Subsequent dosage titrations:
Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the pati"
445657|NCT00601367|P1|Participant Flow|Flibanserin Flexible Dose|"Initial dosage:
Patients were to take one 50 mg flibanserin tablet in the evening.
Subsequent dosage titrations:
Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site."
445658|NCT00601367|O1|Outcome|Flibanserin Flexible Dose|"Initial dosage:
Patients were to take one 50 mg flibanserin tablet in the evening.
Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
445659|NCT00601367|E1|Reported Event|Flibanserin Flexible Dose|"Initial dosage:
Patients were to take one 50 mg flibanserin tablet in the evening.
Subsequent dosage titrations:
Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
445660|NCT00601419|B1|Baseline|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445661|NCT00601419|P1|Participant Flow|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445662|NCT00601419|O2|Outcome|Participants Without ACTH Deficiency|Participants without ACTH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445663|NCT00601419|O1|Outcome|Participants With ACTH Deficiency|Participants with ACTH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445664|NCT00601419|O2|Outcome|Female|Female participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445665|NCT00601419|O1|Outcome|Male|Male participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445666|NCT00601419|O2|Outcome|>=65 Years|Participants older than or equal to 65 years of age while taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445667|NCT00601419|O1|Outcome|<65 Years|Participants younger than 65 years of age while taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445668|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445669|NCT00601419|O4|Outcome|>0.084 mg/kg/Week|Participants taking an initial dose of more than 0.084 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
445670|NCT00601419|O3|Outcome|>=0.042 mg/kg/Week and <=0.084 mg/kg/Week|Participants taking an initial dose of 0.042 mg/kg/week or more and 0.084 mg/kg/week or less of somatropin for adult growth hormone deficiency according to Japanese package insert.
445671|NCT00601419|O2|Outcome|>=0.021 mg/kg/Week and <0.042 mg/kg/Week|Participants taking an initial dose of 0.021 mg/kg/week or more and less than 0.042 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
445672|NCT00601419|O1|Outcome|<0.021 mg/kg/Week|Participants taking an initial dose of less than 0.021 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
445673|NCT00601419|O2|Outcome|Participants Without Past History of Any Disease|Participants without past history of any disease taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445674|NCT00601419|O1|Outcome|Participants With Past History of Any Disease|Participants with past history of any disease taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445675|NCT00601419|O2|Outcome|Participants Without TSH Deficiency|Participants without TSH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445676|NCT00601419|O1|Outcome|Participants With TSH Deficiency|Participants with TSH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445677|NCT00601419|O2|Outcome|Female|Female participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445678|NCT00601419|O1|Outcome|Male|Male participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445679|NCT00601419|O2|Outcome|>=65 Years|Participants older than or equal to 65 years of age when taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445680|NCT00601419|O1|Outcome|<65 Years|Participants younger than 65 years of age when taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445681|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445682|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445683|NCT00601419|E1|Reported Event|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
445684|NCT00601458|B4|Baseline|Total|Total of all reporting groups
445685|NCT00601458|B3|Baseline|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
445686|NCT00601458|B2|Baseline|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg
Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
445687|NCT00601458|B1|Baseline|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg
Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
445688|NCT00601458|P3|Participant Flow|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
445689|NCT00601458|P2|Participant Flow|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg
Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
445690|NCT00601458|P1|Participant Flow|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg
Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
445691|NCT00601458|O3|Outcome|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
445692|NCT00601458|O2|Outcome|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg
Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
445693|NCT00601458|O1|Outcome|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg
Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
445694|NCT00601458|O3|Outcome|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
445695|NCT00601458|O2|Outcome|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg
Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
445696|NCT00601458|O1|Outcome|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg
Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
445697|NCT00601458|E3|Reported Event|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
445698|NCT00601458|E2|Reported Event|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg
Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
446793|NCT00603525|O1|Outcome|Placebo|
445699|NCT00601458|E1|Reported Event|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg
Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
445700|NCT00601523|B3|Baseline|Total|Total of all reporting groups
445701|NCT00601523|B2|Baseline|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445702|NCT00601523|B1|Baseline|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445703|NCT00601523|P2|Participant Flow|Patients From 248.636|Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.636 (NCT00558025) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
445704|NCT00601523|P1|Participant Flow|Patients From 248.524|Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.524 (NCT00479401) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
445705|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445706|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445707|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445708|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445710|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445711|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445712|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445713|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445714|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445715|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445716|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445717|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445718|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445719|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445720|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445721|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445722|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445723|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445724|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445725|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445726|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445727|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445728|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445729|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445730|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445731|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445732|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445733|NCT00601523|E2|Reported Event|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
445734|NCT00601523|E1|Reported Event|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
445735|NCT00601627|B1|Baseline|Panitumumab|"Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
445736|NCT00601627|P1|Participant Flow|Panitumumab|"Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
445737|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
445738|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
446118|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
445739|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
445740|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
445741|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
446025|NCT00602537|P1|Participant Flow|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
446026|NCT00602537|O2|Outcome|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
445742|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
445743|NCT00601627|E1|Reported Event|Panitumumab|6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
445744|NCT00601640|B4|Baseline|Total|Total of all reporting groups
445745|NCT00601640|B3|Baseline|Arm III|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.
445746|NCT00601640|B2|Baseline|Arm II|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
445747|NCT00601640|B1|Baseline|Arm I|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
445748|NCT00601640|P3|Participant Flow|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
445749|NCT00601640|P2|Participant Flow|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
445750|NCT00601640|P1|Participant Flow|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
445751|NCT00601640|O3|Outcome|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
445752|NCT00601640|O2|Outcome|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
445753|NCT00601640|O1|Outcome|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
445754|NCT00601640|O3|Outcome|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90
445755|NCT00601640|O2|Outcome|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
445756|NCT00601640|O1|Outcome|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90
445757|NCT00601640|O3|Outcome|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
445758|NCT00601640|O2|Outcome|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
445759|NCT00601640|O1|Outcome|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
445760|NCT00601640|E3|Reported Event|Arm III|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.
445761|NCT00601640|E2|Reported Event|Arm II|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
445762|NCT00601640|E1|Reported Event|Arm I|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
445763|NCT00601718|B1|Baseline|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
rituximab: Given IV
ifosfamide: Given IV
carboplatin: Given IV
etoposide: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
gene expression analysis: Correlative studies"
445764|NCT00601718|P1|Participant Flow|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
rituximab: Given IV
ifosfamide: Given IV
carboplatin: Given IV
etoposide: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
gene expression analysis: Correlative studies"
445785|NCT00601731|P2|Participant Flow|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
445765|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
rituximab: Given IV
ifosfamide: Given IV
carboplatin: Given IV
etoposide: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
gene expression analysis: Correlative studies"
445766|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
rituximab: Given IV
ifosfamide: Given IV
carboplatin: Given IV
etoposide: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
gene expression analysis: Correlative studies"
445790|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
446027|NCT00602537|O1|Outcome|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
445767|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
rituximab: Given IV
ifosfamide: Given IV
carboplatin: Given IV
etoposide: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
gene expression analysis: Correlative studies"
445768|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
rituximab: Given IV
ifosfamide: Given IV
carboplatin: Given IV
etoposide: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
gene expression analysis: Correlative studies"
445769|NCT00601718|E1|Reported Event|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
rituximab: Given IV
ifosfamide: Given IV
carboplatin: Given IV
etoposide: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
gene expression analysis: Correlative studies"
445770|NCT00601731|B13|Baseline|Total|Total of all reporting groups
445771|NCT00601731|B12|Baseline|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
445772|NCT00601731|B11|Baseline|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
445773|NCT00601731|B10|Baseline|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
445774|NCT00601731|B9|Baseline|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
445775|NCT00601731|B8|Baseline|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445776|NCT00601731|B7|Baseline|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
445777|NCT00601731|B6|Baseline|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
445778|NCT00601731|B5|Baseline|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
445779|NCT00601731|B4|Baseline|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
445780|NCT00601731|B3|Baseline|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445781|NCT00601731|B2|Baseline|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445782|NCT00601731|B1|Baseline|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445783|NCT00601731|P4|Participant Flow|Canada Control|Newly enrolled age-matched subjects that received the complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
445784|NCT00601731|P3|Participant Flow|Canada Sites|Canadian vaccine group that received primary vaccination with MenACWY (adjuvanted and unadjuvanted) vaccine at 2,4 months of age with 12 month booster or at 2, 4, 6 months with or without a booster vaccination.
446119|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
445786|NCT00601731|P1|Participant Flow|UK Site|UK vaccine group that received primary vaccine schedule of MenACWY (adjuvanted and unadjuvanted) vaccine at 2, 3 and 4 months with booster at 12 months of age, enrolled at either 40 or 60 months of age into the current study as follow-on participants.
445787|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
445788|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
445789|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
446028|NCT00602537|O2|Outcome|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
445791|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445792|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
445793|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
445794|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
445795|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
445796|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445797|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445798|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445799|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
445800|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
445801|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
445802|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
445803|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445804|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
445805|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
445806|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
445807|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
445808|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445809|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445810|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445811|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
446120|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
445812|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
445813|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
445814|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
445815|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
446029|NCT00602537|O1|Outcome|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
446030|NCT00602537|E2|Reported Event|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
445816|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
445817|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
445818|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
445819|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
445820|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445821|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445822|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445823|NCT00601731|E12|Reported Event|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
445824|NCT00601731|E11|Reported Event|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
445825|NCT00601731|E10|Reported Event|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
445826|NCT00601731|E9|Reported Event|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
445827|NCT00601731|E8|Reported Event|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445828|NCT00601731|E7|Reported Event|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
445829|NCT00601731|E6|Reported Event|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
445830|NCT00601731|E5|Reported Event|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
445831|NCT00601731|E4|Reported Event|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
445832|NCT00601731|E3|Reported Event|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445833|NCT00601731|E2|Reported Event|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445834|NCT00601731|E1|Reported Event|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
445835|NCT00601796|B1|Baseline|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description
Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.
All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
445836|NCT00601796|P1|Participant Flow|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description
Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.
All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
445859|NCT00601900|P1|Participant Flow|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
446031|NCT00602537|E1|Reported Event|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
446032|NCT00602641|B3|Baseline|Total|Total of all reporting groups
445837|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description
Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.
All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
445838|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description
Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.
All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
445839|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description
Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.
All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
445840|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description
Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.
All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
445841|NCT00601796|E1|Reported Event|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description
Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.
All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
445842|NCT00601835|B3|Baseline|Total|Total of all reporting groups
445843|NCT00601835|B2|Baseline|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
445844|NCT00601835|B1|Baseline|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
445845|NCT00601835|P2|Participant Flow|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
445846|NCT00601835|P1|Participant Flow|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
445847|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
445848|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
445849|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
445850|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
445851|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
445852|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
445853|NCT00601835|E2|Reported Event|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
445854|NCT00601835|E1|Reported Event|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
445855|NCT00601900|B3|Baseline|Total|Total of all reporting groups
445856|NCT00601900|B2|Baseline|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445961|NCT00602446|P1|Participant Flow|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
446794|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
445857|NCT00601900|B1|Baseline|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445858|NCT00601900|P2|Participant Flow|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445908|NCT00602043|B1|Baseline|First Line Endocrine Therapy for a Stage IV Disease|
446047|NCT00602771|B3|Baseline|Total|Total of all reporting groups
445860|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445861|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445862|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445863|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445864|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445865|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445866|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445867|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445868|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445869|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445870|NCT00601900|E2|Reported Event|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445871|NCT00601900|E1|Reported Event|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
445872|NCT00601926|B1|Baseline|Bevacizumab|"15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
445873|NCT00601926|P1|Participant Flow|Bevacizumab|"15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
445874|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
445875|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
445876|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
445877|NCT00601926|E1|Reported Event|Bevacizumab|"15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
445878|NCT00601952|B3|Baseline|Total|Total of all reporting groups
445879|NCT00601952|B2|Baseline|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
445880|NCT00601952|B1|Baseline|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
445881|NCT00601952|P2|Participant Flow|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
445882|NCT00601952|P1|Participant Flow|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
445962|NCT00602446|O1|Outcome|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
445883|NCT00601952|O2|Outcome|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
445909|NCT00602043|P1|Participant Flow|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.
Patients begin clinically indicated endocrine therapy.
Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.
laboratory biomarker analysis: Correlative studies"
447493|NCT00596635|E1|Reported Event|No Cranberry Capsules|Control Group No Cranberry Capsule
445884|NCT00601952|O1|Outcome|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
445885|NCT00601952|E2|Reported Event|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
445886|NCT00601952|E1|Reported Event|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
445887|NCT00601965|B5|Baseline|Total|Total of all reporting groups
445888|NCT00601965|B4|Baseline|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo
Escitalopram: 20 mg daily oral escitalopram
Placebo: Placebo pill of daily oral escitalopram"
445889|NCT00601965|B3|Baseline|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo
Escitalopram: 20 mg daily oral escitalopram
Placebo: Placebo pill of daily oral escitalopram
Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
445890|NCT00601965|B2|Baseline|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram
Escitalopram: 20 mg daily oral escitalopram"
445891|NCT00601965|B1|Baseline|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram
Escitalopram: 20 mg daily oral escitalopram
Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
445892|NCT00601965|P4|Participant Flow|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo
Escitalopram: 20 mg daily oral escitalopram
Placebo: Placebo pill of daily oral escitalopram"
445893|NCT00601965|P3|Participant Flow|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo
Escitalopram: 20 mg daily oral escitalopram
Placebo: Placebo pill of daily oral escitalopram
Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
445894|NCT00601965|P2|Participant Flow|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram
Escitalopram: 20 mg daily oral escitalopram"
445895|NCT00601965|P1|Participant Flow|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram
Escitalopram: 20 mg daily oral escitalopram
Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
445896|NCT00601965|O4|Outcome|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo
Escitalopram: 20 mg daily oral escitalopram
Placebo: Placebo pill of daily oral escitalopram"
445897|NCT00601965|O3|Outcome|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo
Escitalopram: 20 mg daily oral escitalopram
Placebo: Placebo pill of daily oral escitalopram
Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
445898|NCT00601965|O2|Outcome|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram
Escitalopram: 20 mg daily oral escitalopram"
445899|NCT00601965|O1|Outcome|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram
Escitalopram: 20 mg daily oral escitalopram
Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
445900|NCT00601965|O4|Outcome|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo
Escitalopram: 20 mg daily oral escitalopram
Placebo: Placebo pill of daily oral escitalopram"
445901|NCT00601965|O3|Outcome|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo
Escitalopram: 20 mg daily oral escitalopram
Placebo: Placebo pill of daily oral escitalopram
Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
445902|NCT00601965|O2|Outcome|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram
Escitalopram: 20 mg daily oral escitalopram"
445903|NCT00601965|O1|Outcome|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram
Escitalopram: 20 mg daily oral escitalopram
Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
445904|NCT00601965|E4|Reported Event|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo
Escitalopram: 20 mg daily oral escitalopram
Placebo: Placebo pill of daily oral escitalopram"
445905|NCT00601965|E3|Reported Event|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo
Escitalopram: 20 mg daily oral escitalopram
Placebo: Placebo pill of daily oral escitalopram
Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
445906|NCT00601965|E2|Reported Event|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram
Escitalopram: 20 mg daily oral escitalopram"
445963|NCT00602446|O1|Outcome|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
446795|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
445907|NCT00601965|E1|Reported Event|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram
Escitalopram: 20 mg daily oral escitalopram
Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
445910|NCT00602043|O2|Outcome|Diagnostic FES: Patients With FES Negative Sites of Disease|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.
Patients begin clinically indicated endocrine therapy.
Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.
This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan."
445911|NCT00602043|O1|Outcome|Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.
Patients begin clinically indicated endocrine therapy.
Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.
This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.
laboratory biomarker analysis: Correlative studies"
445912|NCT00602043|E1|Reported Event|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.
Patients begin clinically indicated endocrine therapy.
Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.
laboratory biomarker analysis: Correlative studies"
445913|NCT00602290|B4|Baseline|Total|Total of all reporting groups
445914|NCT00602290|B3|Baseline|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
445915|NCT00602290|B2|Baseline|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
445916|NCT00602290|B1|Baseline|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
445917|NCT00602290|P3|Participant Flow|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
445918|NCT00602290|P2|Participant Flow|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
445919|NCT00602290|P1|Participant Flow|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
445964|NCT00602446|E1|Reported Event|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
445965|NCT00602459|B5|Baseline|Total|Total of all reporting groups
446796|NCT00603525|O1|Outcome|Placebo|
445920|NCT00602290|O3|Outcome|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
446672|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
445921|NCT00602290|O2|Outcome|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
445922|NCT00602290|O1|Outcome|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
445923|NCT00602290|E3|Reported Event|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
445924|NCT00602290|E2|Reported Event|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
445925|NCT00602290|E1|Reported Event|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
445926|NCT00602355|B4|Baseline|Total|Total of all reporting groups
445927|NCT00602355|B3|Baseline|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone
Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
445928|NCT00602355|B2|Baseline|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting
Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445929|NCT00602355|B1|Baseline|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting
Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445930|NCT00602355|P3|Participant Flow|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone
Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
445966|NCT00602459|B4|Baseline|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
446797|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
445967|NCT00602459|B3|Baseline|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
446131|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
445931|NCT00602355|P2|Participant Flow|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting
Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445932|NCT00602355|P1|Participant Flow|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting
Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445933|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone
Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
445934|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting
Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445935|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting
Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445936|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone
Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
445937|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting
Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445938|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting
Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445939|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone
Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
445940|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting
Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445941|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting
Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445942|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone
Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
445943|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting
Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445944|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting
Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445945|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone
Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
445946|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting
Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445947|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting
Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445948|NCT00602355|E3|Reported Event|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone
Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
445949|NCT00602355|E2|Reported Event|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting
Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445950|NCT00602355|E1|Reported Event|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting
Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.
Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.
Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
445951|NCT00602420|B3|Baseline|Total|Total of all reporting groups
445952|NCT00602420|B2|Baseline|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
placebo: Oral placebo twice daily for 5-8 days."
445953|NCT00602420|B1|Baseline|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
naproxen: Oral naproxen twice daily for 5-8 days."
445954|NCT00602420|P2|Participant Flow|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
placebo: Oral placebo twice daily for 5-8 days."
445955|NCT00602420|P1|Participant Flow|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
naproxen: Oral naproxen twice daily for 5-8 days."
445956|NCT00602420|O2|Outcome|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
placebo: Oral placebo twice daily for 5-8 days."
445957|NCT00602420|O1|Outcome|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
naproxen: Oral naproxen twice daily for 5-8 days."
445958|NCT00602420|E2|Reported Event|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
placebo: Oral placebo twice daily for 5-8 days."
445959|NCT00602420|E1|Reported Event|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
naproxen: Oral naproxen twice daily for 5-8 days."
445960|NCT00602446|B1|Baseline|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
445968|NCT00602459|B2|Baseline|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
445969|NCT00602459|B1|Baseline|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
445970|NCT00602459|P4|Participant Flow|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
445971|NCT00602459|P3|Participant Flow|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
445972|NCT00602459|P2|Participant Flow|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
445973|NCT00602459|P1|Participant Flow|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
445974|NCT00602459|O2|Outcome|Arm D, FCR+L in Del(11q22.3)|Patients who have del(11q22.3)receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
445975|NCT00602459|O1|Outcome|Arm C2, FCR in Del(11q22.3)|Participants who have del(11q22.3) receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
445976|NCT00602459|O3|Outcome|Arm C1, FCR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (C) (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
445977|NCT00602459|O2|Outcome|Arm B, FR+L in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
445978|NCT00602459|O1|Outcome|Arm A, FR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
445979|NCT00602459|O2|Outcome|Arm D, FCR+L in Del(11q22.3)|Patients who have del(11q22.3)receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
446014|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
446015|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
446016|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
446798|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
445980|NCT00602459|O1|Outcome|Arm C2, FCR in Del(11q22.3)|Participants who have del(11q22.3) receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
445981|NCT00602459|O3|Outcome|Arm C1, FCR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (C) (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
445982|NCT00602459|O2|Outcome|Arm B, FR+L in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
445983|NCT00602459|O1|Outcome|Arm A, FR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
445984|NCT00602459|E4|Reported Event|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
445985|NCT00602459|E3|Reported Event|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
445986|NCT00602459|E2|Reported Event|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
445987|NCT00602459|E1|Reported Event|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: Patients receive rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
445988|NCT00602472|B3|Baseline|Total|Total of all reporting groups
445989|NCT00602472|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
445990|NCT00602472|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
445991|NCT00602472|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
445992|NCT00602472|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
445993|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
445994|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445995|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
445996|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445997|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
445998|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
445999|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
446000|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
446001|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
446002|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
446003|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
446004|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
446005|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
446006|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
446007|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
446008|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
446009|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
446010|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
446011|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
446012|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
446013|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
446799|NCT00603525|O1|Outcome|Placebo|
446019|NCT00602472|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
446020|NCT00602472|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
446021|NCT00602537|B3|Baseline|Total|Total of all reporting groups
446022|NCT00602537|B2|Baseline|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
446023|NCT00602537|B1|Baseline|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
446033|NCT00602641|B2|Baseline|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
melphalan: Given PO
prednisone: Given PO
lenalidomide: Given PO"
446034|NCT00602641|B1|Baseline|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.
melphalan: Given PO
prednisone: Given PO
thalidomide: Given PO"
446035|NCT00602641|P2|Participant Flow|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).
INDUCTION THERAPY: Patients receive melphalan 5 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and lenalidomide 10 mg PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive lenalidomide 10 mg PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
446036|NCT00602641|P1|Participant Flow|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).
INDUCTION THERAPY: Patients receive melphalan 9 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and thalidomide 100 mg PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive thalidomide 100 mg PO daily and continue in the absence of disease progression."
446037|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
446038|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
446039|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
446040|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
446041|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
446042|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
446043|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
446121|NCT00603187|E1|Reported Event|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
446044|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
446045|NCT00602641|E2|Reported Event|mPR-R|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
446046|NCT00602641|E1|Reported Event|MPT-T|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
446048|NCT00602771|B2|Baseline|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
446049|NCT00602771|B1|Baseline|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
446050|NCT00602771|P2|Participant Flow|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
446051|NCT00602771|P1|Participant Flow|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
446052|NCT00602771|O2|Outcome|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
446053|NCT00602771|O1|Outcome|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
446054|NCT00602771|E2|Reported Event|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
446055|NCT00602771|E1|Reported Event|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
446056|NCT00602836|B1|Baseline|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
446057|NCT00602836|P1|Participant Flow|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
446058|NCT00602836|O1|Outcome|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
446059|NCT00602836|E1|Reported Event|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
446060|NCT00602927|B3|Baseline|Total|Total of all reporting groups
446061|NCT00602927|B2|Baseline|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
446062|NCT00602927|B1|Baseline|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
446063|NCT00602927|P2|Participant Flow|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
446064|NCT00602927|P1|Participant Flow|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
446065|NCT00602927|O2|Outcome|Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
446066|NCT00602927|O1|Outcome|Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
446067|NCT00602927|O2|Outcome|Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
446068|NCT00602927|O1|Outcome|Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
446069|NCT00602927|E2|Reported Event|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
446070|NCT00602927|E1|Reported Event|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
446071|NCT00602979|B6|Baseline|Total|Total of all reporting groups
446072|NCT00602979|B5|Baseline|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
446073|NCT00602979|B4|Baseline|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
446074|NCT00602979|B3|Baseline|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
446075|NCT00602979|B2|Baseline|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
446076|NCT00602979|B1|Baseline|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
446077|NCT00602979|P5|Participant Flow|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
446078|NCT00602979|P4|Participant Flow|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
446122|NCT00603239|B3|Baseline|Total|Total of all reporting groups
446079|NCT00602979|P3|Participant Flow|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
446080|NCT00602979|P2|Participant Flow|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
446081|NCT00602979|P1|Participant Flow|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
446082|NCT00602979|O5|Outcome|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
446083|NCT00602979|O4|Outcome|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
446084|NCT00602979|O3|Outcome|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
446132|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446085|NCT00602979|O2|Outcome|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
446086|NCT00602979|O1|Outcome|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
446087|NCT00602979|E5|Reported Event|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)
McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
446088|NCT00602979|E4|Reported Event|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)
GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
446089|NCT00602979|E3|Reported Event|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)
Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
446090|NCT00602979|E2|Reported Event|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)
Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
446091|NCT00602979|E1|Reported Event|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard
Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
446092|NCT00603018|B1|Baseline|1/Recovered Anorevia|"Recovered anorexia
Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
446093|NCT00603018|P1|Participant Flow|Participants Recovered From Anorexia Before + After Fluoxetine|"Participants recovered from anorexia
Fluoxetine: before 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
446094|NCT00603018|O2|Outcome|1/Recovered Anorexia After 8 Weeks of Treatment|"1/Recovered anorexia after 8 weeks of treatment
Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
446095|NCT00603018|O1|Outcome|1/Recovered Anorexia Before 8 Weeks of Treatment|"1/Recovered anorexia before 8 weeks of treatment
Baseline"
446096|NCT00603018|E1|Reported Event|1/Recovered Anorexia|"Recovered anorexia
Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
446097|NCT00603044|B3|Baseline|Total|Total of all reporting groups
446098|NCT00603044|B2|Baseline|No Treatment|Subjects in this arm received no treatment.
446099|NCT00603044|B1|Baseline|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy
fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
446100|NCT00603044|P2|Participant Flow|No Treatment|Subjects in this arm received no treatment.
446101|NCT00603044|P1|Participant Flow|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy
fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
446102|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
446103|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy
fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
446104|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
446105|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy
fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
446106|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
446107|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy
fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
446108|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
446109|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy
fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
446110|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
446111|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy
fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
446112|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
446113|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy
fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
446114|NCT00603044|E2|Reported Event|No Treatment|Subjects in this arm received no treatment.
446115|NCT00603044|E1|Reported Event|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy
fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
446116|NCT00603187|B1|Baseline|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
446123|NCT00603239|B2|Baseline|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446124|NCT00603239|B1|Baseline|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446125|NCT00603239|P2|Participant Flow|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446126|NCT00603239|P1|Participant Flow|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446127|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446128|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446129|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446130|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446133|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446134|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446135|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446136|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446137|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446138|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446139|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446140|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446141|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446142|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446143|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446144|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446145|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446146|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446147|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446148|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446149|NCT00603239|E2|Reported Event|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
446150|NCT00603239|E1|Reported Event|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
446151|NCT00603265|B4|Baseline|Total|Total of all reporting groups
446152|NCT00603265|B3|Baseline|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
446153|NCT00603265|B2|Baseline|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
446154|NCT00603265|B1|Baseline|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
446155|NCT00603265|P3|Participant Flow|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
446156|NCT00603265|P2|Participant Flow|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
446157|NCT00603265|P1|Participant Flow|ADL5859|2 x 50 milligrams (mg) ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
446158|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
446159|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
446160|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
446161|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
446162|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
446163|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
446164|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
446800|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446165|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
446166|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
446167|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
446168|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
446169|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
446170|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
446171|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
446172|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
446173|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
446673|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446174|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
446175|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
446176|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
446177|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
446178|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
446179|NCT00603265|E3|Reported Event|Placebo|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
446180|NCT00603265|E2|Reported Event|Duloxetine|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
446181|NCT00603265|E1|Reported Event|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
446182|NCT00603278|B7|Baseline|Total|Total of all reporting groups
446183|NCT00603278|B6|Baseline|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446184|NCT00603278|B5|Baseline|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446185|NCT00603278|B4|Baseline|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446186|NCT00603278|B3|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446187|NCT00603278|B2|Baseline|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446188|NCT00603278|B1|Baseline|Placebo|Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446189|NCT00603278|P6|Participant Flow|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446190|NCT00603278|P5|Participant Flow|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446191|NCT00603278|P4|Participant Flow|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446192|NCT00603278|P3|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446193|NCT00603278|P2|Participant Flow|GW685698X 100 µg OD|Participants received GW685698X 100 micrograms (µg) OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446639|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446194|NCT00603278|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the novel dry powder inhaler (NDPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446195|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446196|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446197|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446674|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446198|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446199|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446200|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446201|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446202|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446203|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446204|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446205|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446206|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446207|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446208|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446209|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446210|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446211|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446212|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446213|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446801|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446214|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446215|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446216|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446217|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
447494|NCT00596687|B3|Baseline|Total|Total of all reporting groups
446218|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446219|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446220|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446221|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446222|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446223|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446224|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446225|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446226|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446227|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446228|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446229|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446230|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446231|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446232|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446233|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446640|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446802|NCT00603525|O1|Outcome|Placebo|
446234|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446235|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446236|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446379|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446675|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446237|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446238|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446239|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446240|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446241|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446242|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446243|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446244|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446245|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446246|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446247|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446248|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446249|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446250|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446251|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446252|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446253|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446641|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446254|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446255|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446256|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446257|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446258|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446259|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446260|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446261|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446262|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446263|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446264|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446265|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446266|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446267|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446268|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446269|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446270|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446271|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446272|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446273|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446642|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446274|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446275|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446276|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446277|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446278|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446279|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446280|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446281|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446282|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446283|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446284|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446285|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446286|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446287|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446288|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446289|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446290|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446291|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446292|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446293|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446643|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446294|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446295|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446296|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446297|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446298|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446299|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446300|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446301|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446302|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446303|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446304|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446305|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446306|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446307|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446308|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446309|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446310|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446311|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446312|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446313|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446644|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446314|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446315|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446316|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446317|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446318|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446319|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446320|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446321|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446322|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446323|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446324|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446325|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446326|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446327|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446328|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446329|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446330|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446331|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446332|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446333|NCT00603278|E6|Reported Event|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446645|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446334|NCT00603278|E5|Reported Event|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446335|NCT00603278|E4|Reported Event|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446336|NCT00603278|E3|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446337|NCT00603278|E2|Reported Event|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446338|NCT00603278|E1|Reported Event|Placebo|Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446339|NCT00603291|B4|Baseline|Total|Total of all reporting groups
446340|NCT00603291|B3|Baseline|Matching Placebo|matching placebo tablets
446341|NCT00603291|B2|Baseline|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
446342|NCT00603291|B1|Baseline|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
446343|NCT00603291|P3|Participant Flow|Matching Placebo|matching placebo tablets
446344|NCT00603291|P2|Participant Flow|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
446345|NCT00603291|P1|Participant Flow|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
446346|NCT00603291|O3|Outcome|Matching Placebo|matching placebo tablets
446347|NCT00603291|O2|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
446348|NCT00603291|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
446349|NCT00603291|O3|Outcome|Matching Placebo|matching placebo tablets
446350|NCT00603291|O2|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
446351|NCT00603291|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
446352|NCT00603291|E3|Reported Event|Matching Placebo|matching placebo tablets
446353|NCT00603291|E2|Reported Event|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
446354|NCT00603291|E1|Reported Event|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
446355|NCT00603304|B3|Baseline|Total|Total of all reporting groups
446356|NCT00603304|B2|Baseline|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446357|NCT00603304|B1|Baseline|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446358|NCT00603304|P2|Participant Flow|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446359|NCT00603304|P1|Participant Flow|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446360|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446361|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446362|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446363|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446364|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446365|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446366|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446367|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446368|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446369|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446370|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446371|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446372|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446373|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446803|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446374|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446375|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446376|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446377|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446378|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446667|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446380|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446381|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446382|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446383|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446384|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
446385|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
446386|NCT00603304|O2|Outcome|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
446387|NCT00603304|O1|Outcome|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
446388|NCT00603304|O2|Outcome|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
446389|NCT00603304|O1|Outcome|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
446390|NCT00603304|E2|Reported Event|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
446391|NCT00603304|E1|Reported Event|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
446392|NCT00603382|B7|Baseline|Total|Total of all reporting groups
446393|NCT00603382|B6|Baseline|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446394|NCT00603382|B5|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446395|NCT00603382|B4|Baseline|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446396|NCT00603382|B3|Baseline|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446397|NCT00603382|B2|Baseline|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446398|NCT00603382|B1|Baseline|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446399|NCT00603382|P6|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446400|NCT00603382|P5|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446401|NCT00603382|P4|Participant Flow|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446402|NCT00603382|P3|Participant Flow|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446646|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446647|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446403|NCT00603382|P2|Participant Flow|GW685698X 25 µg OD|Participants received GW685698X 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446404|NCT00603382|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446405|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446668|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446406|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446407|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446408|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446409|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446410|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446411|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446412|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446413|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446414|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446415|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446416|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446417|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446418|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446419|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446420|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446421|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446422|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446648|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446423|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446424|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446425|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446669|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446426|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446427|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446428|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446429|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446430|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446431|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446432|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446433|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446434|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446435|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446436|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446437|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446438|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446439|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446440|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446441|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446442|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446649|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446650|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446443|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446444|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446445|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446446|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446447|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446448|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446449|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446450|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446451|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446452|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446453|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446454|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446455|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446456|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446457|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446458|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446459|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446460|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446461|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446462|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446651|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446652|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446463|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446464|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446465|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446466|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446467|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446468|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446469|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446470|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446471|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446472|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446473|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446474|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446475|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446476|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446477|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446478|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446479|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446480|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446481|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446482|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446653|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446654|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446483|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446484|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446485|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446486|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446487|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446488|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446489|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446490|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446491|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446492|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446493|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446494|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446495|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446496|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446497|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446498|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446499|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446500|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446501|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446502|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446655|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446656|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446503|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446504|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446505|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446506|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446507|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446508|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446509|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446510|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446511|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446512|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446513|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446514|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446515|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446516|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446517|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446518|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446519|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446520|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446521|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446522|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446657|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446658|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446523|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446524|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446525|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446526|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446527|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446528|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446529|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446530|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446531|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446532|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446533|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446534|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446535|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446536|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446537|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446538|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446539|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446540|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446541|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446542|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446659|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446660|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446543|NCT00603382|E6|Reported Event|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446544|NCT00603382|E5|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446545|NCT00603382|E4|Reported Event|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446546|NCT00603382|E3|Reported Event|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446547|NCT00603382|E2|Reported Event|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
446548|NCT00603382|E1|Reported Event|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
446549|NCT00603408|B1|Baseline|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection"
446550|NCT00603408|P1|Participant Flow|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection"
446551|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection"
446552|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection"
446553|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection"
446554|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection"
446555|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection"
446556|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection"
446557|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection"
446558|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection"
446559|NCT00603408|E1|Reported Event|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection"
446560|NCT00603447|B8|Baseline|Total|Total of all reporting groups
446579|NCT00603447|O2|Outcome|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446561|NCT00603447|B7|Baseline|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446562|NCT00603447|B6|Baseline|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446670|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446563|NCT00603447|B5|Baseline|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446564|NCT00603447|B4|Baseline|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446565|NCT00603447|B3|Baseline|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446566|NCT00603447|B2|Baseline|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446567|NCT00603447|B1|Baseline|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446568|NCT00603447|P7|Participant Flow|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446569|NCT00603447|P6|Participant Flow|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446570|NCT00603447|P5|Participant Flow|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446571|NCT00603447|P4|Participant Flow|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446572|NCT00603447|P3|Participant Flow|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446573|NCT00603447|P2|Participant Flow|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446574|NCT00603447|P1|Participant Flow|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446575|NCT00603447|O6|Outcome|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446576|NCT00603447|O5|Outcome|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446577|NCT00603447|O4|Outcome|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446578|NCT00603447|O3|Outcome|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446637|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446638|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446778|NCT00603525|O1|Outcome|Placebo|
446580|NCT00603447|O1|Outcome|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446581|NCT00603447|O7|Outcome|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446671|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446582|NCT00603447|O6|Outcome|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446583|NCT00603447|O5|Outcome|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446584|NCT00603447|O4|Outcome|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446585|NCT00603447|O3|Outcome|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446586|NCT00603447|O2|Outcome|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446587|NCT00603447|O1|Outcome|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
446588|NCT00603447|E7|Reported Event|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
446589|NCT00603447|E6|Reported Event|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
446590|NCT00603447|E5|Reported Event|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
446591|NCT00603447|E4|Reported Event|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
446592|NCT00603447|E3|Reported Event|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
446593|NCT00603447|E2|Reported Event|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
446594|NCT00603447|E1|Reported Event|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
446595|NCT00603473|B1|Baseline|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
446596|NCT00603473|P1|Participant Flow|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
446779|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446597|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
447495|NCT00596687|B2|Baseline|SSRI|Sliding scale regular insulin four-times daily.
446598|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
446599|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
446600|NCT00603473|E1|Reported Event|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
446601|NCT00603512|B6|Baseline|Total|Total of all reporting groups
446602|NCT00603512|B5|Baseline|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446603|NCT00603512|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446604|NCT00603512|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446605|NCT00603512|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446606|NCT00603512|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446607|NCT00603512|P5|Participant Flow|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446608|NCT00603512|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446609|NCT00603512|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446610|NCT00603512|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446611|NCT00603512|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446612|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446613|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446614|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446615|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446616|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446617|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446618|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446619|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446620|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446621|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446622|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446623|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446624|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446625|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446626|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446627|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446628|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446629|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446630|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446631|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446632|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446633|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446634|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446635|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446636|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446661|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446662|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446663|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446664|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446665|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446666|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446676|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446677|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446678|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446679|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446680|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446681|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446682|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446683|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446684|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446685|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446686|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446687|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446688|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446689|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446690|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446691|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446692|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446693|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446694|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446695|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446696|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446697|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446698|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446699|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446700|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446701|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446702|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446703|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446704|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446705|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446706|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446707|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446708|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446709|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446710|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446711|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446712|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446713|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446714|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446715|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446716|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446717|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446718|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446719|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446720|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446721|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446722|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446723|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446724|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446725|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446726|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446727|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446728|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446729|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446730|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446731|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446732|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446733|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446734|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446735|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446736|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446737|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446738|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446739|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446740|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446741|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446742|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446743|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446744|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446745|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446746|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446747|NCT00603512|E5|Reported Event|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
446748|NCT00603512|E4|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
446749|NCT00603512|E3|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
446750|NCT00603512|E2|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
446751|NCT00603512|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
446752|NCT00603525|B3|Baseline|Total|Total of all reporting groups
446753|NCT00603525|B2|Baseline|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446754|NCT00603525|B1|Baseline|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446755|NCT00603525|P3|Participant Flow|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
446756|NCT00603525|P2|Participant Flow|Ofatumumab|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
446757|NCT00603525|P1|Participant Flow|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
446758|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446759|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446760|NCT00603525|O1|Outcome|Placebo|
446761|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446762|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446763|NCT00603525|O1|Outcome|Placebo|
446764|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446765|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446766|NCT00603525|O1|Outcome|Placebo|
446767|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446768|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446769|NCT00603525|O1|Outcome|Placebo|
446770|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446771|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446772|NCT00603525|O1|Outcome|Placebo|
446773|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446774|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446775|NCT00603525|O1|Outcome|Placebo|
446776|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446777|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446804|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446805|NCT00603525|O1|Outcome|Placebo|
446806|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446807|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446808|NCT00603525|O1|Outcome|Placebo|
446809|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446810|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446811|NCT00603525|O1|Outcome|Placebo|
446812|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446813|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446814|NCT00603525|O1|Outcome|Placebo|
446815|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446816|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446817|NCT00603525|O1|Outcome|Placebo|
446818|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446819|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446820|NCT00603525|O1|Outcome|Placebo|
446821|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446822|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446823|NCT00603525|O1|Outcome|Placebo|
446824|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446825|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446826|NCT00603525|O1|Outcome|Placebo|
446827|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
446828|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
446829|NCT00603525|O1|Outcome|Placebo|
446830|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446831|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446832|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446833|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446834|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446835|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446836|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446837|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446838|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446839|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446840|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446841|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446842|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446843|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446844|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446845|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446846|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446847|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446848|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446926|NCT00603564|B3|Baseline|Total|Total of all reporting groups
446849|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446850|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446851|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446852|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446853|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446854|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
448583|NCT00606489|P1|Participant Flow|Placebo (250 Milliliters Normal Saline)|
446855|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446856|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446857|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446858|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446859|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446860|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446861|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446862|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446863|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446864|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446865|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446866|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446867|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446868|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446869|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446870|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446871|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446872|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446873|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446927|NCT00603564|B2|Baseline|Venturi|O2 administration via a conventional Venturi mask
446874|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446875|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446876|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446877|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446878|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446879|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
446880|NCT00603525|E3|Reported Event|Placebo or Ofatumumab 700 mg: Follow-up Period|SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
446881|NCT00603525|E2|Reported Event|Ofatumumab 700 mg: DB and OL Periods|SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
446882|NCT00603525|E1|Reported Event|Placebo: DB Period|Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
446883|NCT00603538|B4|Baseline|Total|Total of all reporting groups
446884|NCT00603538|B3|Baseline|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446885|NCT00603538|B2|Baseline|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446886|NCT00603538|B1|Baseline|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446887|NCT00603538|P3|Participant Flow|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446888|NCT00603538|P2|Participant Flow|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446889|NCT00603538|P1|Participant Flow|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446890|NCT00603538|O3|Outcome|CP-751,871 20mg/kg in Combination With Chemotherapy Agents|CP-751,871 20mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446891|NCT00603538|O2|Outcome|CP-751,871 10mg/kg in Combination With Chemotherapy Agents|CP-751,871 10mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446939|NCT00603590|B1|Baseline|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
446940|NCT00603590|P2|Participant Flow|Control|Identical placebo tablet
446941|NCT00603590|P1|Participant Flow|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
446942|NCT00603590|O2|Outcome|Control|Identical placebo tablet
448584|NCT00606489|O2|Outcome|800mg Intravenous Ibuprofen|
446892|NCT00603538|O1|Outcome|CP-751,871 6mg/kg in Combination With Chemotherapy Agents|CP-751,871 6mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446893|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446894|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446895|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446896|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446897|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446898|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446899|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446900|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446901|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446902|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446903|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446904|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446905|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446906|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446907|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446908|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446909|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446910|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446911|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446912|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446913|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446914|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446915|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446916|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446917|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446918|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446919|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446920|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446921|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446922|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446923|NCT00603538|E3|Reported Event|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446924|NCT00603538|E2|Reported Event|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446925|NCT00603538|E1|Reported Event|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
446928|NCT00603564|B1|Baseline|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
446929|NCT00603564|P2|Participant Flow|Venturi|O2 administration via a conventional Venturi mask
446930|NCT00603564|P1|Participant Flow|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
446931|NCT00603564|O2|Outcome|Venturi|O2 administration via a conventional Venturi mask
446932|NCT00603564|O1|Outcome|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
446933|NCT00603564|O2|Outcome|Venturi|O2 administration via a conventional Venturi mask
446934|NCT00603564|O1|Outcome|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
446935|NCT00603564|E2|Reported Event|Venturi|O2 administration via a conventional Venturi mask
446936|NCT00603564|E1|Reported Event|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
446937|NCT00603590|B3|Baseline|Total|Total of all reporting groups
446938|NCT00603590|B2|Baseline|Control|Identical placebo tablet
446943|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
446944|NCT00603590|O2|Outcome|Control|Identical placebo tablet
446945|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
446946|NCT00603590|O2|Outcome|Control|Identical placebo tablet
446947|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
446948|NCT00603590|E2|Reported Event|Control|Identical placebo tablet
446949|NCT00603590|E1|Reported Event|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
446950|NCT00603642|B3|Baseline|Total|Total of all reporting groups
446951|NCT00603642|B2|Baseline|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
446952|NCT00603642|B1|Baseline|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
446953|NCT00603642|P2|Participant Flow|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
446954|NCT00603642|P1|Participant Flow|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
446955|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
446956|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
446957|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
446958|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
446959|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
446960|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
446961|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
446962|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
446963|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
446964|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
446965|NCT00603642|E2|Reported Event|Romiplostim|
446966|NCT00603642|E1|Reported Event|Placebo|
446967|NCT00603733|B3|Baseline|Total|Total of all reporting groups
446968|NCT00603733|B2|Baseline|Pentasa®|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet"
446969|NCT00603733|B1|Baseline|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
446970|NCT00603733|P2|Participant Flow|Pentasa®|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet"
446971|NCT00603733|P1|Participant Flow|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
446972|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet"
446973|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
446974|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet"
446975|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
446976|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet"
446977|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
446978|NCT00603733|E2|Reported Event|Pentasa®|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet"
446979|NCT00603733|E1|Reported Event|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
446980|NCT00603746|B7|Baseline|Total|Total of all reporting groups
446981|NCT00603746|B6|Baseline|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446982|NCT00603746|B5|Baseline|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447703|NCT00603837|B3|Baseline|Total|Total of all reporting groups
446983|NCT00603746|B4|Baseline|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446984|NCT00603746|B3|Baseline|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446985|NCT00603746|B2|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446986|NCT00603746|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
448585|NCT00606489|O1|Outcome|Placebo (250 Milliliters Normal Saline)|
446987|NCT00603746|P6|Participant Flow|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the
446988|NCT00603746|P5|Participant Flow|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446989|NCT00603746|P4|Participant Flow|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446990|NCT00603746|P3|Participant Flow|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446991|NCT00603746|P2|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446992|NCT00603746|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446993|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446994|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446995|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446996|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446997|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446998|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
446999|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447000|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447162|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
447163|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
447001|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447002|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447003|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447004|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447005|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447006|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447007|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447008|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447009|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447010|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447011|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447012|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447013|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447014|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447015|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447016|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447017|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447018|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447019|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447020|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447021|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447022|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447023|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447024|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447025|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447026|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447027|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447028|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447029|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447030|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447031|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447032|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447033|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447034|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447035|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447036|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447037|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447038|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447039|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447040|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447041|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447042|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447043|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447044|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447045|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447046|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447047|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447048|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447049|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447050|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447051|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447052|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447053|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447054|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447055|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447056|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447057|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447058|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447059|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447060|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447061|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447062|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447063|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447064|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447065|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447066|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447067|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447068|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447069|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447070|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447071|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447072|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447073|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447074|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447075|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447164|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
447165|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
447076|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447077|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447078|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447079|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447080|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447081|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447082|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447083|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447084|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447085|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447086|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447087|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447088|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447089|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447090|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447091|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447092|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447093|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447166|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
447167|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
447094|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447095|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447096|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447097|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447098|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447099|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447100|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447101|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447102|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447103|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447104|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447105|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447106|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447107|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447108|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447109|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447110|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447111|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447168|NCT00589914|E2|Reported Event|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
447169|NCT00589914|E1|Reported Event|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
447112|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447113|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447114|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447115|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447116|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447117|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447118|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447119|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447120|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447121|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447122|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447123|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447124|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447125|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447126|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447127|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447128|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447129|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447170|NCT00589979|B3|Baseline|Total|Total of all reporting groups
447171|NCT00589979|B2|Baseline|Sequence: Placebo - Lidoderm - Lidoderm|Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.
447130|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447131|NCT00603746|E6|Reported Event|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447132|NCT00603746|E5|Reported Event|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447176|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
448586|NCT00606489|E2|Reported Event|800mg Intravenous Ibuprofen|
447133|NCT00603746|E4|Reported Event|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447134|NCT00603746|E3|Reported Event|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447135|NCT00603746|E2|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447136|NCT00603746|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
447137|NCT00589849|B1|Baseline|T Wave Altenans Stress Test|
447138|NCT00589849|P1|Participant Flow|T Wave Altenans Stress Test|
447139|NCT00589849|O1|Outcome|T Wave Altenans Stress Test|
447140|NCT00589849|E1|Reported Event|T Wave Altenans Stress Test|
447141|NCT00589888|B1|Baseline|All Study Participants|"All participants received all 5 arms in random order:
0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours
Intralipid 20% @ 20cc/hr for 8 hours
Intralipid 20% @ 40cc/Hr for 8 hours
32-gram Oral Fat Load every 2 hours for 8 hours.
64-gram Oral Fat Loadevery 2 hours for 8 hours."
447142|NCT00589888|P5|Participant Flow|64-gram Oral Fat Load|"64-gram oral fat load
64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours"
447143|NCT00589888|P4|Participant Flow|32-gram Oral Fat Load|"32-gram oral fat load
32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours."
447144|NCT00589888|P3|Participant Flow|Intralipid 20% @ 40cc/Hour|"Intralipid 20% IV infusion at 40cc/hour
Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours"
447145|NCT00589888|P2|Participant Flow|Intralipid 20% @ 20cc/hr|"Intralipid 20% IV infusion at 20cc/hour
Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours"
447146|NCT00589888|P1|Participant Flow|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours
0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
447147|NCT00589888|O1|Outcome|Oral 64-gram Fat Load|For the high (64 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
447148|NCT00589888|O1|Outcome|Oral 32-gram Fat Load|For the low (32 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
447149|NCT00589888|O1|Outcome|Intralipid @ 20cc/Hour|Intralipid continuous IV infusion at 20cc/hour for 8 hours
447150|NCT00589888|O1|Outcome|Intralipid @ 20cc/Hour|Intralipid continuous IV infusion at 20cc/hour for 8 hours
447151|NCT00589888|O1|Outcome|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours
0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
447152|NCT00589888|E5|Reported Event|64-gram Oral Fat Load|"64-gram oral fat load
64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours"
447153|NCT00589888|E4|Reported Event|32-gram Oral Fat Load|"32-gram oral fat load
32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours."
447154|NCT00589888|E3|Reported Event|Intralipid 20% @ 40cc/Hour|"Intralipid 20% IV infusion at 40cc/hour
Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours"
447155|NCT00589888|E2|Reported Event|Intralipid 20% @ 20cc/hr|"Intralipid 20% IV infusion at 20cc/hour
Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours"
447156|NCT00589888|E1|Reported Event|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours
0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
447157|NCT00589914|B3|Baseline|Total|Total of all reporting groups
447158|NCT00589914|B2|Baseline|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
447159|NCT00589914|B1|Baseline|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
447160|NCT00589914|P2|Participant Flow|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
447161|NCT00589914|P1|Participant Flow|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
447172|NCT00589979|B1|Baseline|Sequence: Lidoderm - Placebo - Placebo|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.
447173|NCT00589979|P3|Participant Flow|Treatment Sequence: Placebo - Lidoderm - Lidoderm|Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for up to 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447174|NCT00589979|P2|Participant Flow|Treatment Sequence: Lidoderm - Placebo - Placebo|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for up to 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447175|NCT00589979|P1|Participant Flow|Run-in Period: Lidoderm|Run-in Period with patients applying Lidoderm (lidocaine 5% patch) 10cm x 14cm each on the front and back of the index knee every 24 hours for up to 28 days (4 weeks).
447177|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
447178|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447179|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447180|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
447181|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
447182|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447183|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447184|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447185|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447186|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
447187|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
447188|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447189|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447190|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
447191|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
447192|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447193|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447194|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447195|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447196|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
447313|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
447197|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
447198|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
447199|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
447200|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving Placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
447201|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
447228|NCT00590018|O1|Outcome|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
447202|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447203|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447204|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447205|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (Lidocaine 5% Patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447206|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447207|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
447208|NCT00589979|E3|Reported Event|Double-Blind Active Treatment Period With Placebo|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Placebo during the Double-blind Treatment Period.
A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).
**NOTE: two subjects randomized to the treatment sequence Lidoderm - Placebo - Placebo (PLL) discontinued from the study during treatment with Lidoderm (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Placebo) is equal to 91."
447209|NCT00589979|E2|Reported Event|Double-Blind Treatment Period With Lidoderm|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the Double-blind Treatment Period.
A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).
*NOTE: two subjects randomized to the treatment sequence Placebo - Lidoderm - Lidoderm (PLL) discontinued from the study during treatment with Placebo (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Lidoderm) is equal to 91."
447210|NCT00589979|E1|Reported Event|Run-In Period With Lidoderm (Lidocaine 5% Patch)|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the active treatment Run-in Period.
A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated)."
447211|NCT00590005|B1|Baseline|Children With Asthma|The cohort consists of children with physician-diagnosed asthma across a wide range of severity (mild, moderate, severe)
447212|NCT00590005|P2|Participant Flow|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
447213|NCT00590005|P1|Participant Flow|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
447214|NCT00590005|O2|Outcome|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
447215|NCT00590005|O1|Outcome|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
447216|NCT00590005|O2|Outcome|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
447217|NCT00590005|O1|Outcome|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
447218|NCT00590005|E2|Reported Event|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
447219|NCT00590005|E1|Reported Event|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
447220|NCT00590018|B3|Baseline|Total|Total of all reporting groups
447221|NCT00590018|B2|Baseline|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
447222|NCT00590018|B1|Baseline|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
447223|NCT00590018|P2|Participant Flow|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
447224|NCT00590018|P1|Participant Flow|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
447225|NCT00590018|O2|Outcome|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
447226|NCT00590018|O1|Outcome|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
447227|NCT00590018|O2|Outcome|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
448587|NCT00606489|E1|Reported Event|Placebo (250 Milliliters Normal Saline)|
447229|NCT00590018|E2|Reported Event|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
447230|NCT00590018|E1|Reported Event|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
447231|NCT00590031|B1|Baseline|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
447232|NCT00590031|P1|Participant Flow|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
447233|NCT00590031|O1|Outcome|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
447234|NCT00590031|O1|Outcome|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
447235|NCT00590031|E1|Reported Event|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
447236|NCT00590044|B3|Baseline|Total|Total of all reporting groups
447237|NCT00590044|B2|Baseline|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
447238|NCT00590044|B1|Baseline|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
447239|NCT00590044|P2|Participant Flow|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
447240|NCT00590044|P1|Participant Flow|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
447241|NCT00590044|O2|Outcome|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
447242|NCT00590044|O1|Outcome|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
447243|NCT00590044|E2|Reported Event|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
447244|NCT00590044|E1|Reported Event|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
447245|NCT00590135|B1|Baseline|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily
atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
447246|NCT00590135|P1|Participant Flow|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily
atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
447247|NCT00590135|O1|Outcome|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily
atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
447248|NCT00590135|O1|Outcome|AORTIC STENOSIS PATIENTS|"Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis
atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
447249|NCT00590135|O1|Outcome|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily
atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
447250|NCT00590135|O1|Outcome|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily
atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
447251|NCT00590135|O1|Outcome|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily
atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
447252|NCT00590135|E1|Reported Event|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily
atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
447253|NCT00590161|B3|Baseline|Total|Total of all reporting groups
447254|NCT00590161|B2|Baseline|Placebo TID|29 subjects received placebo as above for one year
447255|NCT00590161|B1|Baseline|Pentoxifylline (PTX) 400 mg PO (by Mouth) TID|26 subjects received PTX at dose above for one year
447256|NCT00590161|P2|Participant Flow|Placebo TID|29 subjects received placebo as above for one year
447257|NCT00590161|P1|Participant Flow|Pentoxifylline (PTX) 400 mg PO Three Times Daily (TID)|26 subjects received PTX at dose above for one year
447258|NCT00590161|O2|Outcome|Placebo Tid|29 subjects received placebo as above for one year
447259|NCT00590161|O1|Outcome|Pentoxifylline 400 mg PO Tid|26 subjects received PTX at dose above for one year
447260|NCT00590161|E2|Reported Event|Placebo Tid|29 subjects received placebo as above for one year
447261|NCT00590161|E1|Reported Event|Pentoxifylline 400 mg PO Tid|26 subjects received PTX at dose above for one year
447262|NCT00590226|B3|Baseline|Total|Total of all reporting groups
447263|NCT00590226|B2|Baseline|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
447264|NCT00590226|B1|Baseline|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
447265|NCT00590226|P2|Participant Flow|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
447266|NCT00590226|P1|Participant Flow|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
447267|NCT00590226|O2|Outcome|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
447268|NCT00590226|O1|Outcome|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
447269|NCT00590226|O2|Outcome|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
447270|NCT00590226|O1|Outcome|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
447271|NCT00590226|E2|Reported Event|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
447272|NCT00590226|E1|Reported Event|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
447273|NCT00590317|B3|Baseline|Total|Total of all reporting groups
447274|NCT00590317|B2|Baseline|Ondansetron|Patients receiving Ondansetron 4 mg IV
447275|NCT00590317|B1|Baseline|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
447276|NCT00590317|P2|Participant Flow|Ondansetron|Patients receiving Ondansetron 4mg IV
447277|NCT00590317|P1|Participant Flow|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
447278|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
447279|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
447280|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
447281|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
447282|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
447283|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
447284|NCT00590317|E2|Reported Event|Ondansetron|Patients receiving Ondansetron 4mg IV
447285|NCT00590317|E1|Reported Event|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
447286|NCT00590369|B3|Baseline|Total|Total of all reporting groups
447287|NCT00590369|B2|Baseline|Versatile One|Versatile One (EZCare)negative wound therapy device
447288|NCT00590369|B1|Baseline|KCI VAC|KCI VAC type negative pressure wound therapy device
447289|NCT00590369|P2|Participant Flow|Versatile One|Versatile One (EZCare)negative wound therapy device
447290|NCT00590369|P1|Participant Flow|KCI VAC|KCI VAC type negative pressure wound therapy device
447291|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
447292|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
447293|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
447294|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
447295|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
447296|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
447297|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
447298|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
447299|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
447300|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
447301|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
447302|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
447303|NCT00590369|E2|Reported Event|Versatile One|Versatile One (EZCare)negative wound therapy device
447304|NCT00590369|E1|Reported Event|KCI VAC|KCI VAC type negative pressure wound therapy device
447305|NCT00590460|B1|Baseline|Group1|only one group
447306|NCT00590460|P1|Participant Flow|Allogeneic Stem Cell Transplant|only one group
447307|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
447308|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
447309|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
447310|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
447311|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
447312|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
453012|NCT00610168|B3|Baseline|Total|Total of all reporting groups
447314|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
447315|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
447316|NCT00590460|E1|Reported Event|Group1|only one group
447317|NCT00590538|B1|Baseline|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.
PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.
Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
447318|NCT00590538|P1|Participant Flow|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.
PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.
Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
447319|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.
PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.
Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
447320|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.
PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.
Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
447321|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.
PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.
Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
447322|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.
PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.
Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
447323|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.
PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.
Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
447324|NCT00590538|E1|Reported Event|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.
PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.
Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
447325|NCT00590564|B1|Baseline|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
447326|NCT00590564|P1|Participant Flow|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
447327|NCT00590564|O1|Outcome|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
447328|NCT00590564|E1|Reported Event|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
447329|NCT00590577|B5|Baseline|Total|Total of all reporting groups
447330|NCT00590577|B4|Baseline|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447331|NCT00590577|B3|Baseline|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447332|NCT00590577|B2|Baseline|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447333|NCT00590577|B1|Baseline|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447334|NCT00590577|P4|Participant Flow|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447335|NCT00590577|P3|Participant Flow|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447336|NCT00590577|P2|Participant Flow|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447337|NCT00590577|P1|Participant Flow|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447338|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447339|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447340|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447341|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447451|NCT00596453|P2|Participant Flow|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
447342|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447343|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447344|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447345|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447346|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447392|NCT00596271|P1|Participant Flow|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
447347|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447348|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447349|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447350|NCT00590577|E4|Reported Event|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447351|NCT00590577|E3|Reported Event|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
447352|NCT00590577|E2|Reported Event|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447353|NCT00590577|E1|Reported Event|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
447354|NCT00590590|B4|Baseline|Total|Total of all reporting groups
447355|NCT00590590|B3|Baseline|Placebo|Placebo administered twice weekly for 4 months
447356|NCT00590590|B2|Baseline|Lidocaine|Lidocaine administered twice weekly for 4 months
447357|NCT00590590|B1|Baseline|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
447358|NCT00590590|P3|Participant Flow|Placebo|Placebo administered twice weekly for 4 months
447359|NCT00590590|P2|Participant Flow|Lidocaine|Lidocaine administered twice weekly for 4 months
447360|NCT00590590|P1|Participant Flow|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
447361|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
447362|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
447363|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
447364|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
447365|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
447366|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
447367|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
447368|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
447369|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
447370|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
447371|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
447372|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
447373|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
447374|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
447375|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
447376|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
447377|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
447378|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
447379|NCT00590590|E3|Reported Event|Placebo|Placebo administered twice weekly for 4 months
447380|NCT00590590|E2|Reported Event|Lidocaine|Lidocaine administered twice weekly for 4 months
447381|NCT00590590|E1|Reported Event|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
447382|NCT00596167|B1|Baseline|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
447383|NCT00596167|P1|Participant Flow|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
447384|NCT00596167|O1|Outcome|Intravenous Antibiotic (Vancomycin)|This study will have only one arm. All six participants in the study will receive an intravenous dose of the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
447452|NCT00596453|P1|Participant Flow|Placebo|Placebo: Placebo twice a day for 14 days
454485|NCT00621504|B3|Baseline|Total|Total of all reporting groups
447385|NCT00596167|E1|Reported Event|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
447386|NCT00596271|B4|Baseline|Total|Total of all reporting groups
447387|NCT00596271|B3|Baseline|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
447388|NCT00596271|B2|Baseline|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
447389|NCT00596271|B1|Baseline|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
447390|NCT00596271|P3|Participant Flow|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
447391|NCT00596271|P2|Participant Flow|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
447393|NCT00596271|O2|Outcome|IC51 + HAVRIX|
447394|NCT00596271|O1|Outcome|HAVRIX + Placebo|
447397|NCT00596271|E3|Reported Event|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
447398|NCT00596271|E2|Reported Event|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
447399|NCT00596271|E1|Reported Event|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
447400|NCT00596362|B1|Baseline|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
447401|NCT00596362|P1|Participant Flow|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
447402|NCT00596362|O1|Outcome|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
447403|NCT00596362|E1|Reported Event|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
447404|NCT00596427|B3|Baseline|Total|Total of all reporting groups
447405|NCT00596427|B2|Baseline|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447406|NCT00596427|B1|Baseline|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447407|NCT00596427|P2|Participant Flow|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447408|NCT00596427|P1|Participant Flow|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447409|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447410|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447411|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447412|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447413|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447414|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447415|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447416|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447417|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447418|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447419|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447420|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447421|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447422|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447496|NCT00596687|B1|Baseline|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
447423|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447424|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447425|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447426|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447427|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447428|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75grams/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447429|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447430|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447431|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
447432|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447433|NCT00596427|E2|Reported Event|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447434|NCT00596427|E1|Reported Event|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
447435|NCT00596440|B3|Baseline|Total|Total of all reporting groups
447436|NCT00596440|B2|Baseline|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
447437|NCT00596440|B1|Baseline|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
447438|NCT00596440|P2|Participant Flow|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
447439|NCT00596440|P1|Participant Flow|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
447440|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
447441|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
447442|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
447443|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
447444|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
447445|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
447446|NCT00596440|E2|Reported Event|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
447447|NCT00596440|E1|Reported Event|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
447448|NCT00596453|B3|Baseline|Total|Total of all reporting groups
447449|NCT00596453|B2|Baseline|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
447450|NCT00596453|B1|Baseline|Placebo|Placebo: Placebo twice a day for 14 days
455090|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
447453|NCT00596453|O2|Outcome|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
447454|NCT00596453|O1|Outcome|Placebo|Placebo: Placebo twice a day for 14 days
447455|NCT00596453|E2|Reported Event|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
447456|NCT00596453|E1|Reported Event|Placebo|Placebo: Placebo twice a day for 14 days
447457|NCT00596466|B1|Baseline|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
447458|NCT00596466|P1|Participant Flow|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
447459|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
447562|NCT00596817|E1|Reported Event|Open-label Period (APTS)|
447460|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
447461|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
447462|NCT00596466|E1|Reported Event|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
447463|NCT00596622|B4|Baseline|Total|Total of all reporting groups
447464|NCT00596622|B3|Baseline|Bipolar Euthymic Subjects Treated With Lithium|"Participants with bipolar mania picture response during fMRI before and after treatment with lithium
Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.
Depression and mania scores before and after treatment"
447465|NCT00596622|B2|Baseline|Bipolar Manic Subjects Treated With Lithium|"Participants with bipolar mania picture response during fMRI before and after treatment with lithium
Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.
Depression and mania scores before and after treatment"
447466|NCT00596622|B1|Baseline|Bipolar Depressed Subjects Treated With Lithium|"Participants with bipolar depression picture response during fMRI before and after treatment with lithium
Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.
Depression and mania scores before and after treatment"
447467|NCT00596622|P1|Participant Flow|Bipolar Subjects Who Were Included in Lithium Treatment Arm|"Participants with bipolar disorder who undergo fMRI and lithium treatment
Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.
Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks."
447468|NCT00596622|O3|Outcome|Bipolar Euthymic Subjects Treated|"Bipolar euthymia picture response before and after treatment with lithium
Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
447469|NCT00596622|O2|Outcome|Bipolar Depressed Subjects Treated|"Bipolar depression picture response during fMRI before and after treatment with lithium
Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
447470|NCT00596622|O1|Outcome|Bipolar Manic Subjects Treated|"Bipolar mania picture response during fMRI before and after treatment with lithium
Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
447471|NCT00596622|O3|Outcome|Bipolar Euthymic Subjects Treated|"Participants with bipolar euthymia who undergo fMRI and lithium treatment
Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.
Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks"
447472|NCT00596622|O2|Outcome|Bipolar Manic Subjects Treated|"Participants with bipolar mania who undergo fMRI and lithium treatment
Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.
Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks"
447473|NCT00596622|O1|Outcome|Bipolar Depressed Participants Treated|"Participants with bipolar depression who undergo fMRI and lithium treatment
Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.
Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks."
447474|NCT00596622|E1|Reported Event|Bipolar Participants Treated|"Participants with bipolar disorder who undergo fMRI and lithium treatment
Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.
Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks.
Adverse Events information was collected irrespective of the sub-grouping"
447475|NCT00596635|B4|Baseline|Total|Total of all reporting groups
447476|NCT00596635|B3|Baseline|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
447477|NCT00596635|B2|Baseline|One Cranberry Capsule|1 650mg cranberry capsule daily
447478|NCT00596635|B1|Baseline|No Cranberry Capsules|Control Group No Cranberry Capsule
447479|NCT00596635|P3|Participant Flow|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
447480|NCT00596635|P2|Participant Flow|One Cranberry Capsule|1 650mg cranberry capsule daily
447481|NCT00596635|P1|Participant Flow|No Cranberry Capsules|Control Group No Cranberry Capsule
447482|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
447483|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
447484|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
447485|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
447486|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
447487|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
447488|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
447489|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
447490|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
447491|NCT00596635|E3|Reported Event|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
447492|NCT00596635|E2|Reported Event|One Cranberry Capsule|1 650mg cranberry capsule daily
447497|NCT00596687|P2|Participant Flow|SSRI|Sliding scale regular insulin four-times daily if blood glucose > 140 before meals and at bedtime. The sliding scale regimen was per the hospital protocol.
447498|NCT00596687|P1|Participant Flow|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine. A total of 0.5 units of insulin/day given, half as basal glargine insulin once a day and the other half as mealtime glulisine given three times a day at meals.
447499|NCT00596687|O2|Outcome|SSRI|Sliding scale regular insulin four-times daily.
447500|NCT00596687|O1|Outcome|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
447501|NCT00596687|O2|Outcome|SSRI|Sliding scale regular insulin four-times daily.
447502|NCT00596687|O1|Outcome|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
447503|NCT00596687|E2|Reported Event|SSRI|Sliding scale regular insulin four-times daily.
447504|NCT00596687|E1|Reported Event|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
447505|NCT00596752|B3|Baseline|Total|Total of all reporting groups
447506|NCT00596752|B2|Baseline|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447507|NCT00596752|B1|Baseline|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447508|NCT00596752|P2|Participant Flow|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447509|NCT00596752|P1|Participant Flow|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447510|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447511|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447512|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447513|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447514|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447515|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447516|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447517|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447546|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
447547|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
447518|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447519|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447520|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447521|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447563|NCT00596830|B3|Baseline|Total|Total of all reporting groups
448014|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
447522|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447523|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447524|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447525|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447526|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447527|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447528|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447529|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447530|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447531|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447532|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447533|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447534|NCT00596752|E2|Reported Event|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo: - Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447535|NCT00596752|E1|Reported Event|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil: - Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion"
447536|NCT00596817|B4|Baseline|Total|Total of all reporting groups
447537|NCT00596817|B3|Baseline|Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)|Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally
447538|NCT00596817|B2|Baseline|Placebo - Double-blind Period (FAS)|Placebo : capsules, daily, orally
447539|NCT00596817|B1|Baseline|Open-label Period (APTS)|
447540|NCT00596817|P2|Participant Flow|Vortioxetine: 5 or 10 mg|Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally
447541|NCT00596817|P1|Participant Flow|Placebo|Placebo : capsules, daily, orally
447542|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
447543|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
447544|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
447545|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
447548|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
447549|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
447550|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
447551|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
447552|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
447553|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
447554|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
447555|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
447556|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
447557|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
447558|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
447559|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
447560|NCT00596817|E3|Reported Event|Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)|
447561|NCT00596817|E2|Reported Event|Placebo - Double-blind Period (FAS)|
447564|NCT00596830|B2|Baseline|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447565|NCT00596830|B1|Baseline|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447566|NCT00596830|P2|Participant Flow|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447567|NCT00596830|P1|Participant Flow|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447568|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447569|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447570|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447571|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447572|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447573|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447574|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447575|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447576|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447577|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447578|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447579|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447651|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
447580|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447581|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447582|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447583|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447584|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447585|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447586|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447587|NCT00596830|E2|Reported Event|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
447588|NCT00596830|E1|Reported Event|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
447589|NCT00596934|B1|Baseline|Metreleptin Treatment Arm|"Treatment group
metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
447590|NCT00596934|P1|Participant Flow|NASH02|"Treatment group
metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
447591|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group
metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
447592|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group
metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
447593|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group
metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
447594|NCT00596934|O1|Outcome|Metreleptin Treatment Group|"Treatment group
metreleptin: 0.1 mg/kg/day once a day via subcutaneous injections"
447595|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group
metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
447596|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group
metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
447597|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group
metreleptin: 0.1 mg/kg/day once a day via subcutaneous injections"
447598|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group
metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
447599|NCT00596934|E1|Reported Event|Metreleptin Treatment Arm|"Treatment group
metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
447600|NCT00596947|B3|Baseline|Total|Total of all reporting groups
447645|NCT00596960|B1|Baseline|Arm 1|"Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
447779|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
447601|NCT00596947|B2|Baseline|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447602|NCT00596947|B1|Baseline|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447710|NCT00603837|E2|Reported Event|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
448588|NCT00606502|B3|Baseline|Total|Total of all reporting groups
447603|NCT00596947|P2|Participant Flow|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447604|NCT00596947|P1|Participant Flow|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447605|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447606|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447607|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447608|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447609|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447610|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447611|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447612|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447613|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447614|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447646|NCT00596960|P2|Participant Flow|Arm 2|"health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
447615|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447616|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
448589|NCT00606502|B2|Baseline|Erlotinib|
447617|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447618|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447619|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447620|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447621|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447622|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447623|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447624|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447625|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447626|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447627|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447628|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447647|NCT00596960|P1|Participant Flow|Arm 1|"Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
447704|NCT00603837|B2|Baseline|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
447629|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447630|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447631|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447632|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447633|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447634|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447635|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447636|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447637|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447638|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447639|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447640|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447641|NCT00596947|E2|Reported Event|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
447642|NCT00596947|E1|Reported Event|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
447643|NCT00596960|B3|Baseline|Total|Total of all reporting groups
447644|NCT00596960|B2|Baseline|Arm 2|"health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
447648|NCT00596960|O2|Outcome|Arm 2|"health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
447649|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
447650|NCT00596960|O2|Outcome|Arm 2|"health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
447711|NCT00603837|E1|Reported Event|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
447652|NCT00596960|O2|Outcome|Arm 2|"health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
447653|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
447654|NCT00596960|E2|Reported Event|Arm 2|"health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
447655|NCT00596960|E1|Reported Event|Arm 1|"Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
447656|NCT00597012|B3|Baseline|Total|Total of all reporting groups
447657|NCT00597012|B2|Baseline|Physical Therapy|Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.
447658|NCT00597012|B1|Baseline|Arthroscopic Partial Meniscectomy|Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
447659|NCT00597012|P2|Participant Flow|Physical Therapy (PT)|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
447660|NCT00597012|P1|Participant Flow|Arthroscopic Partial Meniscectomy (APM)|Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
447661|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
447662|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
447663|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
447664|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
447665|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
447666|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
447667|NCT00597012|E2|Reported Event|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
447668|NCT00597012|E1|Reported Event|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
447669|NCT00597038|B3|Baseline|Total|Total of all reporting groups
447670|NCT00597038|B2|Baseline|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
447671|NCT00597038|B1|Baseline|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
447672|NCT00597038|P2|Participant Flow|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
447673|NCT00597038|P1|Participant Flow|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
447674|NCT00597038|O2|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
447675|NCT00597038|O1|Outcome|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
447676|NCT00597038|O1|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC)
447677|NCT00597038|O1|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC)
447678|NCT00597038|O1|Outcome|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC)
447679|NCT00597038|E2|Reported Event|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
447702|NCT00603798|E1|Reported Event|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447680|NCT00597038|E1|Reported Event|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
447681|NCT00603798|B4|Baseline|Total|Total of all reporting groups
447682|NCT00603798|B3|Baseline|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
448015|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
447683|NCT00603798|B2|Baseline|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447684|NCT00603798|B1|Baseline|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447685|NCT00603798|P3|Participant Flow|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447686|NCT00603798|P2|Participant Flow|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447687|NCT00603798|P1|Participant Flow|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447688|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447689|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447690|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447691|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447692|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447693|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447694|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447695|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447696|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447697|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447698|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447699|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447700|NCT00603798|E3|Reported Event|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447701|NCT00603798|E2|Reported Event|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
447705|NCT00603837|B1|Baseline|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
447706|NCT00603837|P2|Participant Flow|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
447707|NCT00603837|P1|Participant Flow|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
447708|NCT00603837|O2|Outcome|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
447709|NCT00603837|O1|Outcome|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
448590|NCT00606502|B1|Baseline|Pralatrexate|
447712|NCT00603889|B1|Baseline|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
447713|NCT00603889|P1|Participant Flow|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
447714|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
447715|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
447716|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
447717|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
447718|NCT00603889|E1|Reported Event|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
447719|NCT00603902|B4|Baseline|Total|Total of all reporting groups
447720|NCT00603902|B3|Baseline|Matching Placebo|matching placebo tablets
447721|NCT00603902|B2|Baseline|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
447722|NCT00603902|B1|Baseline|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
447723|NCT00603902|P3|Participant Flow|Matching Placebo|matching placebo tablets
447724|NCT00603902|P2|Participant Flow|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
447725|NCT00603902|P1|Participant Flow|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
447726|NCT00603902|O3|Outcome|Matching Placebo|matching placebo tablets
447727|NCT00603902|O2|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
447728|NCT00603902|O1|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
447729|NCT00603902|O3|Outcome|Matching Placebo|matching placebo tablets
447730|NCT00603902|O2|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
447731|NCT00603902|O1|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
447732|NCT00603902|E3|Reported Event|Matching Placebo|matching placebo tablets
447733|NCT00603902|E2|Reported Event|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
447734|NCT00603902|E1|Reported Event|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
447735|NCT00603915|B1|Baseline|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
447736|NCT00603915|P1|Participant Flow|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
447737|NCT00603915|O1|Outcome|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
447738|NCT00603915|O1|Outcome|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
447739|NCT00603915|E1|Reported Event|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
447740|NCT00603993|B1|Baseline|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447741|NCT00603993|P1|Participant Flow|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447742|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447743|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447744|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447745|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447746|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447747|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447748|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447749|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447750|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447751|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447752|NCT00603993|E1|Reported Event|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
447753|NCT00604019|B3|Baseline|Total|Total of all reporting groups
447754|NCT00604019|B2|Baseline|Norepinephrine|Patients that get NE infusion
447755|NCT00604019|B1|Baseline|Dopamine|Patients that get DA infusion
447756|NCT00604019|P2|Participant Flow|Norepinephrine|Norepinephrine infusion via central catheter
447757|NCT00604019|P1|Participant Flow|Dopamine|Dopaime infusion via central catheter
447758|NCT00604019|O2|Outcome|Norepinephrine|Patients getting NE infusion
447759|NCT00604019|O1|Outcome|Dopamine|Patients getting DA infusion
447760|NCT00604019|E2|Reported Event|Norepinephrine|Patients that get NE infusion
447761|NCT00604019|E1|Reported Event|Dopamine|Patients that get DA infusion
447762|NCT00604045|B3|Baseline|Total|Total of all reporting groups
447763|NCT00604045|B2|Baseline|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
447764|NCT00604045|B1|Baseline|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
447765|NCT00604045|P2|Participant Flow|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
447766|NCT00604045|P1|Participant Flow|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
447767|NCT00604045|O2|Outcome|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
447768|NCT00604045|O1|Outcome|1 Attention Bias Modification (ABM)|"The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
be."
447769|NCT00604045|E2|Reported Event|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
447770|NCT00604045|E1|Reported Event|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
447771|NCT00604383|B3|Baseline|Total|Total of all reporting groups
447772|NCT00604383|B2|Baseline|Placebo|1 tablet, orally, daily, for up to 42 months
447773|NCT00604383|B1|Baseline|Ruboxistaurin|One 32-mg tablet, orally, daily, for up to 42 months
447774|NCT00604383|P2|Participant Flow|Placebo|1 tablet, orally, daily, for up to 42 months
447775|NCT00604383|P1|Participant Flow|Ruboxistaurin|One 32-milligram (mg) tablet, orally, daily, for up to 42 months
447776|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
447777|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
447778|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
455422|NCT00614939|O1|Outcome|Placebo|Placebo
447780|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
447781|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
447782|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
447783|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
447784|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
447785|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
447786|NCT00604383|E2|Reported Event|Placebo|1 tablet, orally, daily, for up to 42 months
447787|NCT00604383|E1|Reported Event|Ruboxistaurin|One 32-mg tablet, orally, daily, for up to 42 months
448016|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
447788|NCT00604461|B1|Baseline|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.
B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
447789|NCT00604461|P1|Participant Flow|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.
B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
447790|NCT00604461|O1|Outcome|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.
B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
447791|NCT00604461|O1|Outcome|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.
B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
447792|NCT00604461|E1|Reported Event|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.
B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
447793|NCT00604500|B1|Baseline|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
447794|NCT00604500|P1|Participant Flow|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
447795|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
447796|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
447797|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
447798|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
447799|NCT00604500|E1|Reported Event|MF/F MDI 100/10 mcg BID|Included all participants that received 100/10 mcg BID (with and without dose counter)
447800|NCT00604552|B3|Baseline|Total|Total of all reporting groups
447801|NCT00604552|B2|Baseline|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
447802|NCT00604552|B1|Baseline|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
447803|NCT00604552|P2|Participant Flow|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
447804|NCT00604552|P1|Participant Flow|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
447805|NCT00604552|O2|Outcome|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
447806|NCT00604552|O1|Outcome|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
447807|NCT00604552|E2|Reported Event|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
447808|NCT00604552|E1|Reported Event|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
447809|NCT00604565|B3|Baseline|Total|Total of all reporting groups
447810|NCT00604565|B2|Baseline|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
447811|NCT00604565|B1|Baseline|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)
soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
447812|NCT00604565|P2|Participant Flow|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
447813|NCT00604565|P1|Participant Flow|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)
soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
447814|NCT00604565|O2|Outcome|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
448017|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
447815|NCT00604565|O1|Outcome|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)
soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
447816|NCT00604565|O2|Outcome|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
447817|NCT00604565|O1|Outcome|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)
soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
447818|NCT00604565|E2|Reported Event|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
447819|NCT00604565|E1|Reported Event|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)
soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
447820|NCT00604669|B1|Baseline|Those Exposed to TPN|
447821|NCT00604669|P1|Participant Flow|Those Exposed to TPN|
447822|NCT00604669|O1|Outcome|Those Exposed to TPN|
447823|NCT00604669|E1|Reported Event|Those Exposed to TPN|
447824|NCT00604695|B3|Baseline|Total|Total of all reporting groups
447825|NCT00604695|B2|Baseline|Placebo Control|Two (4mL) doses of sterile saline
447826|NCT00604695|B1|Baseline|Active Treatment|Two (4mg) doses of tenecteplase
447827|NCT00604695|P2|Participant Flow|Placebo Control|Two (4mL) doses of sterile saline
447828|NCT00604695|P1|Participant Flow|Active Treatment|Two (4mg) doses of tenecteplase
447829|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
447830|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
447831|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
447832|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
447833|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
447834|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
447835|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
447836|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
447837|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
447838|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
447839|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
447840|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
447841|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
447842|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
447843|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
447844|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
447845|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
447846|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
447847|NCT00604695|E2|Reported Event|Placebo Control|Two (4mL) doses of sterile saline
447848|NCT00604695|E1|Reported Event|Active Treatment|Two (4mg) doses of tenecteplase
447849|NCT00604708|B3|Baseline|Total|Total of all reporting groups
447850|NCT00604708|B2|Baseline|JE-VAX|JE-VAX
447851|NCT00604708|B1|Baseline|IC51|IC51
447852|NCT00604708|P2|Participant Flow|JE-VAX|JE-VAX
447853|NCT00604708|P1|Participant Flow|IC51|IC51
447854|NCT00604708|O2|Outcome|JE-VAX|JE-VAX
447855|NCT00604708|O1|Outcome|IC51|IC51
447856|NCT00604708|O2|Outcome|JE-VAX|JE-VAX
447857|NCT00604708|O1|Outcome|IC51|IC51
447858|NCT00604708|E2|Reported Event|JE-VAX|JE-VAX
447859|NCT00604708|E1|Reported Event|IC51|IC51
447860|NCT00604721|B1|Baseline|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
447861|NCT00604721|P1|Participant Flow|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
447862|NCT00604721|O1|Outcome|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
447863|NCT00604721|O1|Outcome|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
447864|NCT00604721|O1|Outcome|Safety Cohort: AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was determined by the algorithm presented in the safety cohort."
447865|NCT00604721|E1|Reported Event|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
447866|NCT00604786|B3|Baseline|Total|Total of all reporting groups
447867|NCT00604786|B2|Baseline|Placebo|"placebo: IgE 30-100 int. units/mL: 30-90 kg: placebo every 4 weeks >90-150 kg: placebo every 4 weeks
IgE >100-200 int. units/mL:
30-90 kg: placebo every 4 weeks >90-150 kg: placebo every 2 weeks
IgE >200-300 int. units/mL:
30-60 kg: placebo every 4 weeks >60-90 kg: placebo every 2 weeks >90-150 kg: placebo every 2 weeks
IgE >300-400 int. units/mL:
30-70 kg: placebo every 2 weeks >70-90 kg: placebo every 2 weeks >90 kg: Do not administer dose
IgE >400-500 int. units/mL:
30-70 kg: placebo every 2 weeks >70-90 kg: placebo every 2 weeks >90 kg: Do not administer dose
IgE >500-600 int. units/mL:
30-60 kg: placebo every 2 weeks >60-70 kg: placebo every 2 weeks >70 kg: Do not administer dose
IgE >600-700 int. units/mL:
30-60 kg: placebo every 2 weeks >60 kg: Do not administer dose"
447868|NCT00604786|B1|Baseline|Active Treatment|"This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.
omalizumab: IgE 30-100 int. units/mL: 30-90 kg: 150 mg every 4 weeks >90-150 kg: 300 mg every 4 weeks
IgE >100-200 int. units/mL:
30-90 kg: 300 mg every 4 weeks >90-150 kg: 225 mg every 2 weeks
IgE >200-300 int. units/mL:
30-60 kg: 300 mg every 4 weeks >60-90 kg: 225 mg every 2 weeks >90-150 kg: 300 mg every 2 weeks
IgE >300-400 int. units/mL:
30-70 kg: 225 mg every 2 weeks >70-90 kg: 300 mg every 2 weeks >90 kg: Do not administer dose
IgE >400-500 int. units/mL:
30-70 kg: 300 mg every 2 weeks >70-90 kg: 375 mg every 2 weeks >90 kg: Do not administer dose
IgE >500-600 int. units/mL:
30-60 kg: 300 mg every 2 weeks >60-70 kg: 375 mg every 2 weeks >70 kg: Do not administer dose
IgE >600-700 int. units/mL:
30-60 kg: 375 mg every 2 weeks >60 kg: Do not administer dose"
447869|NCT00604786|P2|Participant Flow|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).
The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
447870|NCT00604786|P1|Participant Flow|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and immunoglobulin E (IgE) based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).
The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
447871|NCT00604786|O2|Outcome|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).
The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
447872|NCT00604786|O1|Outcome|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).
The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
447873|NCT00604786|E2|Reported Event|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).
The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
447874|NCT00604786|E1|Reported Event|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).
The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
447875|NCT00604812|B4|Baseline|Total|Total of all reporting groups
447876|NCT00604812|B3|Baseline|Panel C|Includes the participants who received 5 mg rizatriptan (n=1), 10 mg rizatriptan (n=4), and the matching placebo (n=1)
447877|NCT00604812|B2|Baseline|Panel B|Includes the participants from the 10 mg rizatriptan group (10) and the matching placebo group (3)
447878|NCT00604812|B1|Baseline|Panel A|Includes the participants from the 5 mg rizatriptan group (9) and the matching placebo group (3)
447910|NCT00604851|E2|Reported Event|Placebo|placebo : participants < 30 kg: 15 mg po once daily participants <= 30 kg: 30 mg po once daily
455423|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
447879|NCT00604812|P6|Participant Flow|Panel C Placebo|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
448591|NCT00606502|P2|Participant Flow|Erlotinib|150 mg tablet taken orally daily
447880|NCT00604812|P5|Participant Flow|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
447881|NCT00604812|P4|Participant Flow|Panel B Placebo|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1.
Subjects weighing 40 kg and above were allocated to Panel B."
447882|NCT00604812|P3|Participant Flow|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 40 kg and above were allocated to Panel B."
447883|NCT00604812|P2|Participant Flow|Panel A Placebo|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1.
Subjects weighing 20-39 kg were allocated to Panel A."
447884|NCT00604812|P1|Participant Flow|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 20-39 kg were allocated to Panel A."
447885|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
447886|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 40 kg and above were allocated to Panel B."
447887|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 20-39 kg were allocated to Panel A."
447888|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
447889|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 40 kg and above were allocated to Panel B."
447890|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 20-39 kg were allocated to Panel A."
447891|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
447892|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 40 kg and above were allocated to Panel B."
447893|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 20-39 kg were allocated to Panel A."
447894|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
447895|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 40 kg and above were allocated to Panel B."
447896|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
Subjects weighing 20-39 kg were allocated to Panel A."
447897|NCT00604812|O3|Outcome|Placebo|Combined Placebo groups from panels A, B, and C.
447898|NCT00604812|O2|Outcome|Rizatriptan 10 mg|Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
447899|NCT00604812|O1|Outcome|Rizatriptan 5 mg|Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
447900|NCT00604812|E3|Reported Event|Placebo|Combined Placebo groups from panels A, B, and C.
447901|NCT00604812|E2|Reported Event|Rizatriptan 10 mg|Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
447902|NCT00604812|E1|Reported Event|Rizatriptan 5 mg|Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
447903|NCT00604851|B3|Baseline|Total|Total of all reporting groups
447904|NCT00604851|B2|Baseline|Placebo|placebo : participants < 30 kg: 15 mg po once daily participants <= 30 kg: 30 mg po once daily
447905|NCT00604851|B1|Baseline|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg po once daily
447906|NCT00604851|P2|Participant Flow|Placebo|placebo medication, taken by mouth once daily
447907|NCT00604851|P1|Participant Flow|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg taken by mouth once daily, participants >= 30 kg: 30 mg taken by mouth once daily
447908|NCT00604851|O2|Outcome|Placebo|placebo : participants < 30 kg: 15 mg po once daily participants <= 30 kg: 30 mg po once daily
447909|NCT00604851|O1|Outcome|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg po once daily
447911|NCT00604851|E1|Reported Event|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg po once daily
447912|NCT00604968|B1|Baseline|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
448840|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
447913|NCT00604968|P1|Participant Flow|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447914|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447915|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447916|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447917|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447918|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447919|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447920|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447921|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447922|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447923|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447924|NCT00604968|E1|Reported Event|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
447925|NCT00605033|B3|Baseline|Total|Total of all reporting groups
447926|NCT00605033|B2|Baseline|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
447927|NCT00605033|B1|Baseline|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
447928|NCT00605033|P2|Participant Flow|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
447929|NCT00605033|P1|Participant Flow|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
447930|NCT00605033|O2|Outcome|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
447931|NCT00605033|O1|Outcome|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
447932|NCT00605033|E2|Reported Event|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
447933|NCT00605033|E1|Reported Event|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
447934|NCT00605072|B4|Baseline|Total|Total of all reporting groups
447935|NCT00605072|B3|Baseline|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447936|NCT00605072|B2|Baseline|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447980|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447937|NCT00605072|B1|Baseline|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447938|NCT00605072|P3|Participant Flow|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447939|NCT00605072|P2|Participant Flow|Candesartan|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447940|NCT00605072|P1|Participant Flow|Lisinopril|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447941|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447942|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447943|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447944|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447945|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447946|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447947|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447948|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447949|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447950|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447951|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
448010|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
447952|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447953|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447954|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447955|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447956|NCT00605072|E3|Reported Event|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447957|NCT00605072|E2|Reported Event|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447958|NCT00605072|E1|Reported Event|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months
nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
447959|NCT00605085|B3|Baseline|Total|Total of all reporting groups
447960|NCT00605085|B2|Baseline|Placebo|Placebo
447961|NCT00605085|B1|Baseline|IC51|IC51
447962|NCT00605085|P2|Participant Flow|Placebo|Placebo
447963|NCT00605085|P1|Participant Flow|IC51|IC51
447964|NCT00605085|O2|Outcome|Placebo|Placebo
447965|NCT00605085|O1|Outcome|IC51|IC51
447966|NCT00605085|E2|Reported Event|Placebo|Placebo
447967|NCT00605085|E1|Reported Event|IC51|IC51
447968|NCT00605150|B1|Baseline|TheraSphere Treatment|Total number of patients enrolled, TheraSphere treatment
447969|NCT00605150|P1|Participant Flow|Treatment|TheraSphere, TheraSphere-Yttrium 90 microsphere, treatment for patients with unresectable hepatocellular carcinoma (HCC)
447970|NCT00605150|O1|Outcome|TheraSphere Treatment|Total number of patients enrolled TheraSphere treatment for patients with unresectable HCC
447971|NCT00605150|E1|Reported Event|TheraSphere Treatment for Patients With Unresectable HCC|Total number of patients enrolled, TheraSphere treatment for patients with unresectable HCC
447972|NCT00605176|B4|Baseline|Total|Total of all reporting groups
447973|NCT00605176|B3|Baseline|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447974|NCT00605176|B2|Baseline|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447975|NCT00605176|B1|Baseline|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447976|NCT00605176|P3|Participant Flow|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447977|NCT00605176|P2|Participant Flow|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447978|NCT00605176|P1|Participant Flow|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447979|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
448011|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
447981|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447982|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447983|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447984|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447985|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447986|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447987|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447988|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447989|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447990|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447991|NCT00605176|E3|Reported Event|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447992|NCT00605176|E2|Reported Event|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447993|NCT00605176|E1|Reported Event|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
447994|NCT00605202|B1|Baseline|Entire Study Population|
447995|NCT00605202|P2|Participant Flow|Licorice and HCTZ First, Then Licorice|Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the first intervention period, then licorice 32 grams a day in the second intervention period.
447996|NCT00605202|P1|Participant Flow|Licorice First, Then Licorice and HCTZ|Licorice 32 grams a day in the first intervention period, then licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the second intervention period.
447997|NCT00605202|O2|Outcome|Licorice and HCTZ|
447998|NCT00605202|O1|Outcome|Licorice|
447999|NCT00605202|E2|Reported Event|Licorice and HCTZ|Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily
448000|NCT00605202|E1|Reported Event|Licorice|Licorice 32 grams a day
448001|NCT00605267|B3|Baseline|Total|Total of all reporting groups
448002|NCT00605267|B2|Baseline|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448003|NCT00605267|B1|Baseline|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448004|NCT00605267|P2|Participant Flow|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448005|NCT00605267|P1|Participant Flow|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448006|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448007|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448008|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448009|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
455424|NCT00614939|O1|Outcome|Placebo|Placebo
448012|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448013|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448018|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448019|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448020|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448021|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448022|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448023|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448024|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448025|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448026|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448027|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448028|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448029|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448030|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448031|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448032|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448033|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448034|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448035|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448036|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448037|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448038|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448039|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448040|NCT00605267|E2|Reported Event|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448041|NCT00605267|E1|Reported Event|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
448042|NCT00605280|B5|Baseline|Total|Total of all reporting groups
448043|NCT00605280|B4|Baseline|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
448044|NCT00605280|B3|Baseline|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
448045|NCT00605280|B2|Baseline|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448046|NCT00605280|B1|Baseline|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448047|NCT00605280|P4|Participant Flow|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448048|NCT00605280|P3|Participant Flow|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from the study.
448049|NCT00605280|P2|Participant Flow|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks for 2 years or withdrawing from the study.
448050|NCT00605280|P1|Participant Flow|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448051|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448052|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448053|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448054|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448055|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448056|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448057|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448058|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448059|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448060|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448061|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448062|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448063|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448064|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448065|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448066|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448067|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448068|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448069|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448070|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448816|NCT00600119|B6|Baseline|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
448071|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448072|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448073|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448074|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448075|NCT00605280|E6|Reported Event|Sham Conversion (Year 3)|Participants who were originally randomized to Sham who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448076|NCT00605280|E5|Reported Event|0.3 mg Pegaptanib Sodium (Year 3)|Participants who were originally randomized to pegaptanib sodium, 0.3 mg who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
448077|NCT00605280|E4|Reported Event|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe) from baseline up to Year 2. Events reported for participants after start of sham, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
448078|NCT00605280|E3|Reported Event|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
448079|NCT00605280|E2|Reported Event|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
448080|NCT00605280|E1|Reported Event|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks from baseline up to 2 years. Includes participants randomized to 0.3 mg pegaptanib sodium and participants randomized to lower doses of pegaptanib sodium who then converted to 0.3 mg pegaptanib sodium; for participants who converted to 0.3 mg pegaptanib sodium, only events that occurred while receiving 0.3 mg pegaptanib sodium treatment are reported.
448081|NCT00605293|B3|Baseline|Total|Total of all reporting groups
448082|NCT00605293|B2|Baseline|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
448083|NCT00605293|B1|Baseline|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
448084|NCT00605293|P2|Participant Flow|Epoetin Alfa|Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), and 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.
448085|NCT00605293|P1|Participant Flow|C.E.R.A|Participants received starting dose of 120, 200 or 360 micrograms (mcg) of C.E.R.A intravenously (IV) once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
448086|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
448087|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
448088|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
448089|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
448090|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
448091|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
448092|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
448093|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
448094|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
448095|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
448096|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
448097|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
448098|NCT00605293|E2|Reported Event|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
448099|NCT00605293|E1|Reported Event|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
448100|NCT00605306|B3|Baseline|Total|Total of all reporting groups
448185|NCT00605423|E2|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
448101|NCT00605306|B2|Baseline|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
448102|NCT00605306|B1|Baseline|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
448103|NCT00605306|P2|Participant Flow|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
448104|NCT00605306|P1|Participant Flow|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
448105|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
448106|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
448107|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
448108|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
448109|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
448110|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
448111|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
448112|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
448113|NCT00605306|E2|Reported Event|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
448114|NCT00605306|E1|Reported Event|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
448115|NCT00605345|B3|Baseline|Total|Total of all reporting groups
448116|NCT00605345|B2|Baseline|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
448117|NCT00605345|B1|Baseline|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
448118|NCT00605345|P2|Participant Flow|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
448119|NCT00605345|P1|Participant Flow|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
448120|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
448121|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
448122|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
448123|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
448124|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
448125|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
448126|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
448127|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
448128|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
448129|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
448130|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
448131|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
448132|NCT00605345|E2|Reported Event|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
448133|NCT00605345|E1|Reported Event|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
448134|NCT00605358|B3|Baseline|Total|Total of all reporting groups
448135|NCT00605358|B2|Baseline|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:
an evaluation
referral to a local mental health provider
booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
448136|NCT00605358|B1|Baseline|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:
receive an evaluation
receive a referral to a local mental health provider
identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
448180|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
448137|NCT00605358|P2|Participant Flow|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:
an evaluation
referral to a local mental health provider
booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
448138|NCT00605358|P1|Participant Flow|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:
receive an evaluation
receive a referral to a local mental health provider
identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
448186|NCT00605423|E1|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
448139|NCT00605358|O2|Outcome|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:
an evaluation
referral to a local mental health provider
booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
448140|NCT00605358|O1|Outcome|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:
receive an evaluation
receive a referral to a local mental health provider
identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
448141|NCT00605358|E2|Reported Event|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:
an evaluation
referral to a local mental health provider
booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
448142|NCT00605358|E1|Reported Event|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:
receive an evaluation
receive a referral to a local mental health provider
identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
448143|NCT00605384|B3|Baseline|Total|Total of all reporting groups
448144|NCT00605384|B2|Baseline|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448145|NCT00605384|B1|Baseline|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448146|NCT00605384|P2|Participant Flow|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448147|NCT00605384|P1|Participant Flow|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448148|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448149|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448150|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448151|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448152|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448153|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448154|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448155|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448156|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448157|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448158|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448159|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448160|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448161|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448162|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448163|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448164|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448165|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448166|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448167|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448168|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448169|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448170|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448171|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448172|NCT00605384|E2|Reported Event|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
448173|NCT00605384|E1|Reported Event|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
448174|NCT00605423|B3|Baseline|Total|Total of all reporting groups
448175|NCT00605423|B2|Baseline|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
448176|NCT00605423|B1|Baseline|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
448177|NCT00605423|P2|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
448178|NCT00605423|P1|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
448179|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
448181|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
448182|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
448183|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
448184|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
448188|NCT00605475|B10|Baseline|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
448189|NCT00605475|B9|Baseline|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448190|NCT00605475|B8|Baseline|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
448191|NCT00605475|B7|Baseline|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448192|NCT00605475|B6|Baseline|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448193|NCT00605475|B5|Baseline|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448194|NCT00605475|B4|Baseline|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
448195|NCT00605475|B3|Baseline|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448196|NCT00605475|B2|Baseline|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
448197|NCT00605475|B1|Baseline|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
448198|NCT00605475|P10|Participant Flow|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
448199|NCT00605475|P9|Participant Flow|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448200|NCT00605475|P8|Participant Flow|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
448201|NCT00605475|P7|Participant Flow|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448202|NCT00605475|P6|Participant Flow|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448203|NCT00605475|P5|Participant Flow|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448204|NCT00605475|P4|Participant Flow|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
448205|NCT00605475|P3|Participant Flow|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448206|NCT00605475|P2|Participant Flow|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
448207|NCT00605475|P1|Participant Flow|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
448208|NCT00605475|O10|Outcome|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
448209|NCT00605475|O9|Outcome|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448210|NCT00605475|O8|Outcome|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
448211|NCT00605475|O7|Outcome|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448212|NCT00605475|O6|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448213|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448214|NCT00605475|O4|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
448215|NCT00605475|O3|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448216|NCT00605475|O2|Outcome|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
448217|NCT00605475|O1|Outcome|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
448218|NCT00605475|O7|Outcome|Cohort 4: Anakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448219|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) : Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
448220|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448221|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448222|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448223|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448224|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448225|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448226|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
448227|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448228|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448229|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448230|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448231|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448817|NCT00600119|B5|Baseline|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
448232|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448233|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448234|NCT00605475|O7|Outcome|Cohort 4:Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448235|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
448236|NCT00605475|O5|Outcome|Cohort 3:Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448237|NCT00605475|O4|Outcome|Cohort 3:Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448238|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448239|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448240|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448241|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448242|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
448243|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448244|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448245|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448246|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448247|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448248|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448249|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo of cohort 3 and 4. Single dose IV infusion of Placebo
448250|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448251|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448252|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448253|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448254|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448255|NCT00605475|O7|Outcome|Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448256|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
448257|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448258|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448259|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448260|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448261|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448262|NCT00605475|O7|Outcome|Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448263|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
448264|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448265|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448266|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448267|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448268|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448269|NCT00605475|O7|Outcome|Cohort 4:Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448270|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
448271|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448272|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448273|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448274|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448275|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448276|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448277|NCT00605475|O6|Outcome|Pooled (Cohort 3and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
448278|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448279|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448280|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448281|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448282|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448283|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448284|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
455425|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
448285|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448286|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448287|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448288|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448289|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448290|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448291|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from cohort 3 and 4. ingle dose IV infusion of Placebo
448292|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448293|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448294|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448295|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448296|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448297|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448298|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
448299|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448300|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448301|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448302|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448303|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448304|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448305|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
448306|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448307|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448308|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448309|NCT00605475|O2|Outcome|Cohort 2:Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448310|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448311|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448312|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
448313|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448314|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448315|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448316|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448317|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448318|NCT00605475|E10|Reported Event|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
448319|NCT00605475|E9|Reported Event|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
448320|NCT00605475|E8|Reported Event|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
448321|NCT00605475|E7|Reported Event|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
448322|NCT00605475|E6|Reported Event|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
448323|NCT00605475|E5|Reported Event|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
448324|NCT00605475|E4|Reported Event|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
448325|NCT00605475|E3|Reported Event|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
448326|NCT00605475|E2|Reported Event|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
448327|NCT00605475|E1|Reported Event|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
448328|NCT00605540|B1|Baseline|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
448329|NCT00605540|P1|Participant Flow|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
448330|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
448331|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
448332|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
448333|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
448818|NCT00600119|B4|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
448334|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
448335|NCT00605540|E1|Reported Event|Chronic Obstructive Pulmonary Disease|
448336|NCT00605657|B1|Baseline|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
448337|NCT00605657|P1|Participant Flow|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
448761|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
448338|NCT00605657|O1|Outcome|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
448339|NCT00605657|O1|Outcome|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
448340|NCT00605657|E1|Reported Event|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
448341|NCT00605696|B3|Baseline|Total|Total of all reporting groups
448342|NCT00605696|B2|Baseline|Control Group|"Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.
Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
448343|NCT00605696|B1|Baseline|Early Insulin Group|"Participants will receive IIT within 6-12 hours after presenting to ED.
Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
448344|NCT00605696|P2|Participant Flow|Control Group|Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission.
448345|NCT00605696|P1|Participant Flow|Early Insulin Group|Participants will receive insulin to target glucose of 80-110 mg/dl within 6-12 hours after presenting to ED for up to 48 hours after admission to the ICU.
448346|NCT00605696|O2|Outcome|Control Group|Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.
448347|NCT00605696|O1|Outcome|Early Insulin Group|Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) in the ED and after ICU admission for up to 48 hours.
448348|NCT00605696|O2|Outcome|Control Group|Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.
448349|NCT00605696|O1|Outcome|Early Insulin Group|Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) in the ED and after ICU admission for up to 48 hours.
448350|NCT00605696|E2|Reported Event|Control Group|"Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.
Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
448351|NCT00605696|E1|Reported Event|Early Insulin Group|"Participants will receive IIT within 6-12 hours after presenting to ED.
Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
448352|NCT00605722|B1|Baseline|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
448353|NCT00605722|P1|Participant Flow|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
448354|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
448355|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
448356|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
448357|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
448358|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
448359|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
448360|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
448361|NCT00605722|E1|Reported Event|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
448362|NCT00605813|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
448363|NCT00605813|P1|Participant Flow|Sertraline|Participants taking Sertraline according to Japanese Package Insert
448364|NCT00605813|O2|Outcome|Present History of Intentional Suicidal Ideation|Participants with present intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
448365|NCT00605813|O1|Outcome|Past History of Intentional Suicidal Ideation|Participants with past history of intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
448366|NCT00605813|O2|Outcome|Without Non-pharmaceutical Therapies|Participants without non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
448367|NCT00605813|O1|Outcome|With Non-pharmaceutical Therapies|Participants with non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
448368|NCT00605813|O2|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
448369|NCT00605813|O1|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
448370|NCT00605813|O2|Outcome|With Renal Dysfunction|Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
448371|NCT00605813|O1|Outcome|Without Renal Dysfunction|Participants without renal dysfunction who took Sertraline according to Japanese Package Insert
448372|NCT00605813|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
448373|NCT00605813|O1|Outcome|Sertraline Hydrochloride|Participants who took Sertraline according to Japanese Package Insert
448374|NCT00605813|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert
448375|NCT00605839|B4|Baseline|Total|Total of all reporting groups
448376|NCT00605839|B3|Baseline|Usual Care|Usual care, without cell phone or glucopak
448377|NCT00605839|B2|Baseline|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
448378|NCT00605839|B1|Baseline|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
448379|NCT00605839|P3|Participant Flow|Usual Care|Usual care, without Glucopak or cell phones.
448380|NCT00605839|P2|Participant Flow|Cell Phone Only|Cell phone only. Participants are given cell phones and encouraged to keep in contact with the clinic.
448381|NCT00605839|P1|Participant Flow|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. Participants use the experimental device and are actively monitored by the clinic.
448382|NCT00605839|O3|Outcome|Usual Care|Usual care, without cell phone or glucopak
448383|NCT00605839|O2|Outcome|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
448384|NCT00605839|O1|Outcome|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
448385|NCT00605839|E3|Reported Event|Usual Care|Usual care, without cell phone or glucopak
448386|NCT00605839|E2|Reported Event|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
448387|NCT00605839|E1|Reported Event|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
448388|NCT00605865|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
448389|NCT00605865|P1|Participant Flow|Sertraline|Participants taking Sertraline according to Japanese Package Insert
448390|NCT00605865|O2|Outcome|Without Suicidal Ideation (Including Suicide Attempt)|Participants without suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
448391|NCT00605865|O1|Outcome|With Suicidal Ideation (Including Suicide Attempt)|Participants with suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
448392|NCT00605865|O4|Outcome|Over 65 Years of Age|Participants over 65 years of age who took Sertraline according to Japanese Package Insert
448393|NCT00605865|O3|Outcome|45-64 Years of Age|Participants from 45 to 64 years of age who took Sertraline according to Japanese Package Insert
448394|NCT00605865|O2|Outcome|18-44 Years of Age|Participants from 18 to 44 years of age who took Sertraline according to Japanese Package Insert
448395|NCT00605865|O1|Outcome|Under 18 Years of Age|Participants under 18 years of age who took Sertraline according to Japanese Package Insert
448396|NCT00605865|O2|Outcome|Under 15 Years|Participants under 15 years of age who took Sertraline according to Japanese Package Insert
448397|NCT00605865|O1|Outcome|15 Years and Higher|Participants 15 years and higher of age who took Sertraline according to Japanese Package Insert
448398|NCT00605865|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
448399|NCT00605865|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
448400|NCT00605865|O2|Outcome|Outpatient|Participants as outpatients who took Sertraline according to Japanese Package Insert
448401|NCT00605865|O1|Outcome|Inpatient|Participants as inpatients who took Sertraline according to Japanese Package Insert
448402|NCT00605865|O2|Outcome|Without History of Treatment Prior to Sertraline|Participants without history of treatment prior to administration of Sertraline who took Sertraline according to Japanese Package Insert
448403|NCT00605865|O1|Outcome|With History of Treatment Prior to Sertraline|Participants with history of treatment prior to administration of Sertraline who took Sertraline according to Japanese Package Insert
448404|NCT00605865|O3|Outcome|Severe|Participants whose target disease are severe and who took Sertraline according to Japanese Package Insert
448405|NCT00605865|O2|Outcome|Moderate|Participants whose target disease are moderate and who took Sertraline according to Japanese Package Insert
448406|NCT00605865|O1|Outcome|Mild|Participants whose target disease are mild and who took Sertraline according to Japanese Package Insert
455426|NCT00614939|O1|Outcome|Placebo|Placebo
448407|NCT00605865|O2|Outcome|Under 15 Years|Participants under 15 years of age who took Sertraline according to Japanese Package Insert
448408|NCT00605865|O1|Outcome|15 Years and Higher|Participants 15 years and higher of age who took Sertraline according to Japanese Package Insert
448409|NCT00605865|O2|Outcome|Without Suicidal Ideation (Including Suicide Attempt)|Participants without suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
448410|NCT00605865|O1|Outcome|With Suicidal Ideation (Including Suicide Attempt)|Participants with suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
448411|NCT00605865|O5|Outcome|>=100mg|Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
448762|NCT00606801|O1|Outcome|Placebo - Baseline|Measures prior to medication administration.
448412|NCT00605865|O4|Outcome|>=75mg, <100mg|Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
448413|NCT00605865|O3|Outcome|>=50mg, <75mg|Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
448414|NCT00605865|O2|Outcome|>=25mg, <50mg|Participants who took more than 25mg and less than 50mg of Sertraline a day on average according to Japanese Package Insert
448415|NCT00605865|O1|Outcome|<25mg|Participants who took less than 25mg of Sertraline a day on average according to Japanese Package Insert
448416|NCT00605865|O2|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
448417|NCT00605865|O1|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
448418|NCT00605865|O2|Outcome|Without Renal Dysfunction|Participants without renal dysfunction who took Sertraline according to Japanese Package Insert
448419|NCT00605865|O1|Outcome|With Renal Dysfunction|Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
448420|NCT00605865|O2|Outcome|Without Concomitant Drug|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
448421|NCT00605865|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
448422|NCT00605865|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
448423|NCT00605865|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
448424|NCT00605865|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
448425|NCT00605865|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
448426|NCT00605865|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert. All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
448427|NCT00605904|B3|Baseline|Total|Total of all reporting groups
448428|NCT00605904|B2|Baseline|Placebo|Subjects received 3 tablets of placebo three times daily
448429|NCT00605904|B1|Baseline|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
448430|NCT00605904|P2|Participant Flow|Placebo|Subjects received 3 tablets of placebo three times daily
448431|NCT00605904|P1|Participant Flow|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
448432|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
448433|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
448434|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
448435|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
448436|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
448437|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
448438|NCT00605904|E2|Reported Event|Placebo|Subjects received 3 tablets of placebo three times daily
448439|NCT00605904|E1|Reported Event|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
448440|NCT00605917|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
448441|NCT00605917|P1|Participant Flow|Sertraline|"Participants taking Sertraline according to Japanese Package Insert; This study is Special Investigation of JZOLOFT for panic disorder and one of conditions of this study is patients who are diagnosed with panic disorder. So, all of participants in this study are panic disorder patients."
448442|NCT00605917|O5|Outcome|Drank Alcohol Every Day|Participants who drank alcohol every day and who took Sertraline according to Japanese Package Insert
448443|NCT00605917|O4|Outcome|Drank Alcohol Moderately|Participants who drank alcohol moderately and who took Sertraline according to Japanese Package Insert
448444|NCT00605917|O3|Outcome|Used to Drink Alcohol But Did Not Then|Participants who used to drink alcohol but did not then and who took Sertraline according to Japanese Package Insert
448445|NCT00605917|O2|Outcome|Drank Alcohol Very Occasionally|Participants who drank alcohol very occasionally and who took Sertraline according to Japanese Package Insert
448446|NCT00605917|O1|Outcome|Didn’t Drink Alcohol at All, and Had Never Drunk Alcohol|Participants who didn’t drink alcohol at all, and had never drunk alcohol and who took Sertraline according to Japanese Package Insert
448447|NCT00605917|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
448448|NCT00605917|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
448449|NCT00605917|O2|Outcome|Without Concomitrant|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
448450|NCT00605917|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
448451|NCT00605917|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
448452|NCT00605917|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
448453|NCT00605917|O5|Outcome|>=100mg|Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
448454|NCT00605917|O4|Outcome|>=75mg, <100mg|Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
448455|NCT00605917|O3|Outcome|>=50mg, <75mg|Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
448456|NCT00605917|O2|Outcome|>=25mg, <50mg|Participants who took more than 25mg and less than 50mg of Sertraline a day on average according to Japanese Package Insert
448457|NCT00605917|O1|Outcome|<25mg|Participants who took less than 25mg of Sertraline a day on average according to Japanese Package Insert
448458|NCT00605917|O2|Outcome|Without History of Treatment|Participants without history of treatment prior to administration of Sertralin who took Sertraline according to Japanese Package Insert
448459|NCT00605917|O1|Outcome|With History of Treatment|Participants with history of treatment prior to administration of Sertralin who took Sertraline according to Japanese Package Insert
448460|NCT00605917|O2|Outcome|Without Non-pharmaceutical Therapies|Participants without non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
448461|NCT00605917|O1|Outcome|With Non-pharmaceutical Therapies|Participants with non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
448462|NCT00605917|O2|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
448463|NCT00605917|O1|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
448464|NCT00605917|O3|Outcome|Smoke Then|Participants who smoke then and who took Sertraline according to Japanese Package Insert
448465|NCT00605917|O2|Outcome|Used to Smoke But do Not Then|Participants who used to smoke but didn't then and who took Sertraline according to Japanese Package Insert
448466|NCT00605917|O1|Outcome|Don’t Smoke at All|Participants who didn't smoke at all and who took Sertraline according to Japanese Package Insert
448467|NCT00605917|O2|Outcome|Without Family History|Participants without family history of psychiatric disorders who took Sertraline according to Japanese Package Insert
448468|NCT00605917|O1|Outcome|With Family History|Participants with family history of psychiatric disorders who took Sertraline according to Japanese Package Insert
448469|NCT00605917|O2|Outcome|Without Concomitant Drug|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
448470|NCT00605917|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
448471|NCT00605917|O5|Outcome|Other Than Those Above|Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
448472|NCT00605917|O4|Outcome|100mg|Participants whose starting dose were 100mg
448473|NCT00605917|O3|Outcome|75mg|Participants whose starting dose were 75mg
448474|NCT00605917|O2|Outcome|50mg|Participants whose starting dose were 50mg
448475|NCT00605917|O1|Outcome|25mg|Participants whose starting dose were 25mg
448476|NCT00605917|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
448477|NCT00605917|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
448478|NCT00605917|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert.The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
448479|NCT00606008|B1|Baseline|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.
Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
448480|NCT00606008|P1|Participant Flow|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.
Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
448481|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
448482|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
448483|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.
Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
448484|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
448485|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
448486|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.
Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
448487|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
448488|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
448520|NCT00606034|E1|Reported Event|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
448521|NCT00606086|B3|Baseline|Total|Total of all reporting groups
455427|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
448489|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.
Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
448490|NCT00606008|E3|Reported Event|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
448491|NCT00606008|E2|Reported Event|AA Cohort Patients|Recurrent glioblastoma (GB) patients
448763|NCT00606801|E2|Reported Event|Placebo|Placebo given for 10 days.
448492|NCT00606008|E1|Reported Event|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.
Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
448493|NCT00606021|B3|Baseline|Total|Total of all reporting groups
448494|NCT00606021|B2|Baseline|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
448495|NCT00606021|B1|Baseline|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
448496|NCT00606021|P3|Participant Flow|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
448497|NCT00606021|P2|Participant Flow|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 (mg/m²), IV, Day 1 of each 21-day cycle for 6 cycles
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
448498|NCT00606021|P1|Participant Flow|Pemetrexed Plus Cisplatin (Induction Phase)|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles
448499|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
448500|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
448501|NCT00606021|O3|Outcome|Pemetrexed Plus Cisplatin (Induction Phase)|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles
448502|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
448503|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
448504|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
448505|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
448506|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
448507|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
448508|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
448509|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
448510|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
448511|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
448512|NCT00606021|E3|Reported Event|Pemetrexed + Cisplatin - Induction Phase|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles.
448513|NCT00606021|E2|Reported Event|Best Supportive Care - Maintenance Phase|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
448514|NCT00606021|E1|Reported Event|Pemetrexed Plus Best Supportive Care - Maintenance Phase|Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
448515|NCT00606034|B1|Baseline|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
448516|NCT00606034|P1|Participant Flow|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
448517|NCT00606034|O1|Outcome|All Subjects|All subjects will receive the IDRSQ at baseline and at Week 52
448518|NCT00606034|O1|Outcome|All Subjects|
448519|NCT00606034|O1|Outcome|All Subjects Using U-500 Regular Insulin Via Omnipod|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
448522|NCT00606086|B2|Baseline|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
448764|NCT00606801|E1|Reported Event|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
448523|NCT00606086|B1|Baseline|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
448524|NCT00606086|P2|Participant Flow|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
448525|NCT00606086|P1|Participant Flow|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
448526|NCT00606086|O2|Outcome|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
448527|NCT00606086|O1|Outcome|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
448528|NCT00606086|E2|Reported Event|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
448529|NCT00606086|E1|Reported Event|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
448530|NCT00606138|B3|Baseline|Total|Total of all reporting groups
448531|NCT00606138|B2|Baseline|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
448532|NCT00606138|B1|Baseline|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
448533|NCT00606138|P2|Participant Flow|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
448534|NCT00606138|P1|Participant Flow|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
448535|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
448536|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
448537|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
448538|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
448539|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
448540|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
448541|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
448542|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
448543|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
448544|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
448819|NCT00600119|B3|Baseline|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
448545|NCT00606138|E2|Reported Event|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
448546|NCT00606138|E1|Reported Event|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
448547|NCT00606177|B3|Baseline|Total|Total of all reporting groups
448548|NCT00606177|B2|Baseline|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.
Subjects were administered placebo once daily for 154 days."
448549|NCT00606177|B1|Baseline|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.
Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
448550|NCT00606177|P2|Participant Flow|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.
Subjects were administered placebo once daily for 154 days."
448551|NCT00606177|P1|Participant Flow|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.
Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
448552|NCT00606177|O2|Outcome|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.
Subjects were administered placebo once daily for 154 days."
448553|NCT00606177|O1|Outcome|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.
Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
448554|NCT00606177|O2|Outcome|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.
Subjects were administered placebo once daily for 154 days."
448555|NCT00606177|O1|Outcome|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.
Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
448556|NCT00606177|E2|Reported Event|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.
Subjects were administered placebo once daily for 154 days."
448557|NCT00606177|E1|Reported Event|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.
Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
448558|NCT00606229|B1|Baseline|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
448559|NCT00606229|P1|Participant Flow|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
448560|NCT00606229|O1|Outcome|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
448561|NCT00606229|O1|Outcome|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
448562|NCT00606229|E1|Reported Event|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
448563|NCT00606281|B3|Baseline|Total|Total of all reporting groups
448564|NCT00606281|B2|Baseline|Placebo|Subjects were administered placebo once daily for 21 days.
448565|NCT00606281|B1|Baseline|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
448566|NCT00606281|P2|Participant Flow|Placebo|Subjects were administered placebo once daily for 21 days.
448567|NCT00606281|P1|Participant Flow|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
448568|NCT00606281|O2|Outcome|Placebo|Subjects were administered placebo once daily for 21 days.
448569|NCT00606281|O1|Outcome|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
448570|NCT00606281|O2|Outcome|Placebo|Subjects were administered placebo once daily for 21 days.
448571|NCT00606281|O1|Outcome|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
448572|NCT00606281|E2|Reported Event|Placebo|Subjects were administered placebo once daily for 21 days.
448573|NCT00606281|E1|Reported Event|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
448574|NCT00606320|B1|Baseline|Arupiprazole|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.
Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
448575|NCT00606320|P1|Participant Flow|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.
Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
448576|NCT00606320|O1|Outcome|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.
Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
448577|NCT00606320|O1|Outcome|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.
Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
448578|NCT00606320|E1|Reported Event|Aripiprazole|Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.
448579|NCT00606489|B3|Baseline|Total|Total of all reporting groups
448580|NCT00606489|B2|Baseline|800mg Intravenous Ibuprofen|
448581|NCT00606489|B1|Baseline|Placebo (250 Milliliters Normal Saline)|
448592|NCT00606502|P1|Participant Flow|Pralatrexate|190 or 230 mg/m2 starting dose with increases or decreases to 150 to 270 mg/m2 per protocol, administered as an IV push over 3-5 minutes on days 1 and 15 of a 4-week cycle (ie, every 2 weeks)
448593|NCT00606502|O2|Outcome|Erlotinib|
448594|NCT00606502|O1|Outcome|Pralatrexate|
448595|NCT00606502|O2|Outcome|Erlotinib|
448596|NCT00606502|O1|Outcome|Pralatrexate|
448597|NCT00606502|O2|Outcome|Erlotinib|
448598|NCT00606502|O1|Outcome|Pralatrexate|
448599|NCT00606502|O2|Outcome|Erlotinib|
448600|NCT00606502|O1|Outcome|Pralatrexate|
448601|NCT00606502|E2|Reported Event|Erlotinib|
448602|NCT00606502|E1|Reported Event|Pralatrexate|
448603|NCT00606554|B3|Baseline|Total|Total of all reporting groups
448604|NCT00606554|B2|Baseline|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.
Comparator group"
448605|NCT00606554|B1|Baseline|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
448606|NCT00606554|P2|Participant Flow|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.
Comparator group"
448607|NCT00606554|P1|Participant Flow|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
448608|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.
Comparator group"
448609|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
448610|NCT00606554|O2|Outcome|Standard of Care Weaning|comparator arm
448611|NCT00606554|O1|Outcome|Computer-assisted Weaning|intervention arm
448612|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.
Comparator group"
448613|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
448614|NCT00606554|E2|Reported Event|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.
Comparator group"
448615|NCT00606554|E1|Reported Event|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
448616|NCT00606580|B4|Baseline|Total|Total of all reporting groups
448617|NCT00606580|B3|Baseline|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448618|NCT00606580|B2|Baseline|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448619|NCT00606580|B1|Baseline|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448620|NCT00606580|P3|Participant Flow|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448621|NCT00606580|P2|Participant Flow|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448622|NCT00606580|P1|Participant Flow|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448623|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448624|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448625|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448753|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
448626|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448627|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448628|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448629|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448765|NCT00600015|B3|Baseline|Total|Total of all reporting groups
448766|NCT00600015|B2|Baseline|Placebo|Erlotinib + Placebo
448630|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448631|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448632|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448633|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448634|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448635|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448636|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448637|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448638|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448639|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448640|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448641|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448642|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448643|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448644|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448645|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448646|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448647|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448648|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448820|NCT00600119|B2|Baseline|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
448649|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448650|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448651|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448767|NCT00600015|B1|Baseline|Combination Therapy|Erlotinib + Sorafenib
448768|NCT00600015|P2|Participant Flow|Placebo|Erlotinib + Placebo
448769|NCT00600015|P1|Participant Flow|Combination Therapy|Erlotinib + Sorafenib
448652|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448653|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448654|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448655|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448656|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448657|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448658|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448659|NCT00606580|E3|Reported Event|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
448660|NCT00606580|E2|Reported Event|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
448661|NCT00606580|E1|Reported Event|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
448662|NCT00606593|B1|Baseline|Patient Flow|The study consisted of a 2-4-week screening phase (including 2 consecutive screening polysomnography (PSG) nights on single blind placebo), a 4- to 8-week treatment phase, and a 28 day safety follow-up. The treatment phase immediately followed randomization and included 5 treatment periods, each consisting of 2 consecutive treatment PSG nights on the assigned study treatment separated by 5 to 12 days of washout. Subjects were randomized to one of 10 treatment sequences.
448663|NCT00606593|P10|Participant Flow|Treatment Sequence 50/100/25/200/P|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 200 mg/placebo.
448664|NCT00606593|P9|Participant Flow|Treatment Sequence 100/200/50/P/25|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 200 mg/ACT-078573 50 mg/placebo/ACT-078573 25 mg.
448665|NCT00606593|P8|Participant Flow|Treatment Sequence 200/P/100/25/50|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 200 mg/placebo/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 50 mg.
448666|NCT00606593|P7|Participant Flow|Treatment Sequence P/25/200/50/100|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 25 mg/ACT-078573 200 mg/ACT-078573 50 mg/ACT-078573 100 mg.
448667|NCT00606593|P6|Participant Flow|Treatment Sequence 25/50/P/100/200|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/ACT-078573 50 mg/placebo/ACT-078573 100 mg/ACT-078573 200 mg.
448754|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
448755|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
448668|NCT00606593|P5|Participant Flow|Treatment Sequence P/200/25/100/50|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 200 mg/ACT-078573 25 mg/ACT-078573 100 mg/ACT-078573 50 mg.
448700|NCT00606684|B3|Baseline|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448770|NCT00600015|O2|Outcome|Placebo|Erlotinib + Placebo
448669|NCT00606593|P4|Participant Flow|Treatment Sequence 25/P/50/200/100|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/placebo/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 100 mg.
448670|NCT00606593|P3|Participant Flow|Treatment Sequence 50/25/100/P/200|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 25 mg/ACT-078573 100 mg/placebo/ACT-078573 200 mg.
448671|NCT00606593|P2|Participant Flow|Treatment Sequence 100/50/200/25/P|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 25 mg/placebo.
448672|NCT00606593|P1|Participant Flow|Treatment Sequence 200/100/P/50/25|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: almorexant (ACT-078573) 200 mg/ACT-078573 100 mg/Placebo/ACT-078573 50 mg/ACT-078573 25mg.
448673|NCT00606593|O5|Outcome|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
448674|NCT00606593|O4|Outcome|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
448675|NCT00606593|O3|Outcome|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
448676|NCT00606593|O2|Outcome|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
448677|NCT00606593|O1|Outcome|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
448678|NCT00606593|O5|Outcome|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
448679|NCT00606593|O4|Outcome|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
448680|NCT00606593|O3|Outcome|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
448681|NCT00606593|O2|Outcome|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
448682|NCT00606593|O1|Outcome|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
448683|NCT00606593|E6|Reported Event|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
448684|NCT00606593|E5|Reported Event|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
448685|NCT00606593|E4|Reported Event|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
448686|NCT00606593|E3|Reported Event|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
448687|NCT00606593|E2|Reported Event|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
448688|NCT00606593|E1|Reported Event|Single-blind Placebo|Treatment administered during screening period
448689|NCT00606632|B1|Baseline|PET/CT Versus CT|All subjects were scheduled to receive a PET/CT and a diagnostic CT
448690|NCT00606632|P1|Participant Flow|PET/CT Versus CT|PET/CT and CT scans for all study subjects 4 days (+/- 2 days) after 124I cG250 administration.
448691|NCT00606632|O4|Outcome|Specificity CT|"Specificity of CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.
The specificity refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC)."
448692|NCT00606632|O3|Outcome|Specificity PET/CT|"Specificity of PET/CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.
The specificity of refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC)."
448693|NCT00606632|O2|Outcome|Sensitivity CT|"Sensitivity of diagnostic CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.
The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC."
448694|NCT00606632|O1|Outcome|Sensitivity PET/CT|"Sensitivity of 124I-cG250 PET/CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.
The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC."
448695|NCT00606632|E1|Reported Event|PET/CT Versus CT|All subjects were scheduled to receive a PET/CT and a diagnostic CT
448696|NCT00606684|B7|Baseline|Total|Total of all reporting groups
448697|NCT00606684|B6|Baseline|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448698|NCT00606684|B5|Baseline|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448815|NCT00600119|B7|Baseline|Total|Total of all reporting groups
448699|NCT00606684|B4|Baseline|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448760|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
448771|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
448701|NCT00606684|B2|Baseline|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448702|NCT00606684|B1|Baseline|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448703|NCT00606684|P7|Participant Flow|GW642444M 50 µg|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448704|NCT00606684|P6|Participant Flow|GW642444M 25 µg|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448705|NCT00606684|P5|Participant Flow|GW642444M 12.5 µg|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448706|NCT00606684|P4|Participant Flow|GW642444M 6.25 µg|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448707|NCT00606684|P3|Participant Flow|GW642444M 3 µg|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448708|NCT00606684|P2|Participant Flow|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448709|NCT00606684|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning from the novel dual strip dry powder inhaler. In addition, all participants were provided supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used asneeded throughout the study.
448710|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448711|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448712|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448713|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448714|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448715|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448716|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448717|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448718|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448719|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448720|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448721|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448722|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448723|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448724|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448725|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448726|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448727|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448728|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448729|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448730|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448731|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448732|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448733|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448734|NCT00606684|E6|Reported Event|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448735|NCT00606684|E5|Reported Event|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448736|NCT00606684|E4|Reported Event|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448737|NCT00606684|E3|Reported Event|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448738|NCT00606684|E2|Reported Event|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448739|NCT00606684|E1|Reported Event|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
448740|NCT00606801|B3|Baseline|Total|Total of all reporting groups
448741|NCT00606801|B2|Baseline|Placebo|Placebo given for 10 days.
448742|NCT00606801|B1|Baseline|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
448743|NCT00606801|P2|Participant Flow|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
448744|NCT00606801|P1|Participant Flow|Placebo|Placebo given for 10 days.
448745|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
448746|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
448747|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
448748|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
448749|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
448750|NCT00606801|O1|Outcome|Placebo - Baseline|Measures in placebo group prior to medication administration.
448751|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
448752|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
448984|NCT00600743|O6|Outcome|Normal 1 mg Placebo|Normal 1 mg dose placebo
448756|NCT00606801|O1|Outcome|Placebo - Baseline|Measures in placebo group prior to medication administration.
448757|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
448758|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
448759|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
448772|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
448775|NCT00600015|E1|Reported Event|All Study Participants|"Reported SAEs and AEs for all study participants -
Combination Therapy: Erlotinib + Sorafenib Placebo: Erlotinib + Placebo"
448776|NCT00600028|B3|Baseline|Total|Total of all reporting groups
448777|NCT00600028|B2|Baseline|Placebo First, Then Thalidomide Drug|Placebo was administered in the first intervention period and Thalidomide 50 - 100 mg daily in the second intervention period(After washout period)
448778|NCT00600028|B1|Baseline|Drug Thalidomide First, Then Placebo|Drug thalidomide 50 - 100 mg daily in the first intervention period and placebo daily in the second intervention period (after washout period)
448779|NCT00600028|P2|Participant Flow|Placebo First, Then Thalidomide Drug|Placebo was administered in the first interventional period and Thalidomide 50-100mg daily in the second interventional period (after washout period).
448780|NCT00600028|P1|Participant Flow|Drug Thalidomide First, Then Placebo|Drug Thalidomide 50-100mg daily in the first intervention period and placebo daily in the second intervention period (after washout period)
448781|NCT00600028|O4|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the second intervention period
448782|NCT00600028|O3|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50-100 mg by mouth per day in the first intervention period
448783|NCT00600028|O2|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50-100 mg by mouth per day in the second intervention period
448784|NCT00600028|O1|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the first intervention period
448785|NCT00600028|O4|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the second intervention period
448786|NCT00600028|O3|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50 - 100 mg by mouth daily in the first intervention period
448787|NCT00600028|O2|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50-100 mg by mouth per day in the second intervention period
448788|NCT00600028|O1|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the first intervention period
448789|NCT00600028|E2|Reported Event|Placebo|Placebo : Placebo 50-100 mg by mouth per day
448790|NCT00600028|E1|Reported Event|Thalidomide|Thalidomide : thalidomide 50 - 100 mg by mouth daily
448791|NCT00600067|B3|Baseline|Total|Total of all reporting groups
448792|NCT00600067|B2|Baseline|Active|PHEN/TPM 15/92
448793|NCT00600067|B1|Baseline|Placebo|
448794|NCT00600067|P2|Participant Flow|VI-0521|phentermine 15 mg/topiramate 92 mg
448795|NCT00600067|P1|Participant Flow|Placebo|
448796|NCT00600067|O2|Outcome|VI-0521|phentermine 15mg/topiramate 92mg
448797|NCT00600067|O1|Outcome|Placebo|
448798|NCT00600067|O2|Outcome|VI-0521|phentermine 15mg/topiramate 92 mg
448799|NCT00600067|O1|Outcome|Placebo|
448800|NCT00600067|E2|Reported Event|Active|PHEN/TPM 15/92
448801|NCT00600067|E1|Reported Event|Placebo|
448802|NCT00600080|B1|Baseline|All Subjects|All subjects crossed over to use each treatment for one week
448803|NCT00600080|P2|Participant Flow|Nelfilcon A/Etafilcon A|nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2.
448804|NCT00600080|P1|Participant Flow|Etafilcon A/Nelfilcon A|etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2.
448805|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
448806|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
448807|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
448808|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
448809|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
448810|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
448811|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
448812|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
448813|NCT00600080|E2|Reported Event|Nelfilcon A First Etafilcon A Second|nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2
448814|NCT00600080|E1|Reported Event|Etafilcon A First Nelfilcon A Second|etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2
448821|NCT00600119|B1|Baseline|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
448822|NCT00600119|P6|Participant Flow|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
448823|NCT00600119|P5|Participant Flow|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
448824|NCT00600119|P4|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
448825|NCT00600119|P3|Participant Flow|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
448826|NCT00600119|P2|Participant Flow|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
448827|NCT00600119|P1|Participant Flow|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
448828|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
448829|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
448830|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
448831|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
448832|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
448833|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
448834|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
448835|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
448836|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
448837|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
448838|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
448839|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
448841|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
448842|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
448843|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
448844|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
448845|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
448846|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
448847|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
448848|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
448849|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
448850|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
448851|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
448852|NCT00600119|E6|Reported Event|Placebo 50 mg|
448853|NCT00600119|E5|Reported Event|Placebo 5 mg|
448854|NCT00600119|E4|Reported Event|Placebo 25 mg|
448855|NCT00600119|E3|Reported Event|NKTR-118 50 mg|
448856|NCT00600119|E2|Reported Event|NKTR-118 5 mg|
448857|NCT00600119|E1|Reported Event|NKTR-118 25 mg|
448858|NCT00600171|B7|Baseline|Total|Total of all reporting groups
448859|NCT00600171|B6|Baseline|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448860|NCT00600171|B5|Baseline|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448861|NCT00600171|B4|Baseline|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448862|NCT00600171|B3|Baseline|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448863|NCT00600171|B2|Baseline|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448864|NCT00600171|B1|Baseline|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448865|NCT00600171|P6|Participant Flow|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448866|NCT00600171|P5|Participant Flow|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448867|NCT00600171|P4|Participant Flow|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448868|NCT00600171|P3|Participant Flow|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448985|NCT00600743|O5|Outcome|Binge - 4mg Plc|binge - 4mg placebo
448869|NCT00600171|P2|Participant Flow|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448870|NCT00600171|P1|Participant Flow|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448871|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448872|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448873|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
449008|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449009|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
448874|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448875|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448876|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448877|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448878|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448879|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448880|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448881|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448882|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448883|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448884|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448885|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448886|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448887|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448888|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448986|NCT00600743|O4|Outcome|Normal_4mg d|Normal_4mg drug
448987|NCT00600743|O3|Outcome|Normal_2mg d|Normal_2mg drug
448988|NCT00600743|O2|Outcome|Normal_1mg d|Normal_1mg drug
448989|NCT00600743|O1|Outcome|Binge_4mg d|Binge_4mg drug
448889|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448890|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448891|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448892|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448893|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448894|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448895|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448896|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448897|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448898|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448899|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448900|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448901|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448902|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448903|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448904|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg µgon non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448905|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448906|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448907|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448908|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448990|NCT00600743|O8|Outcome|Normal_4 mg Dose Placebo|Eat normally 4 mg dose placebo
448991|NCT00600743|O7|Outcome|Normal_2 mg Dose Placebo|Eat normally 2 mg dose placebo
448992|NCT00600743|O6|Outcome|Normal 1 mg Dose Placebo|Eat normally 1 mg dose placebo
448909|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448910|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448911|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448912|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448913|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448914|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448915|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448916|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448917|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448918|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448919|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448920|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448921|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µgon non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448922|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448923|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448924|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448925|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448926|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448927|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448928|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448993|NCT00600743|O5|Outcome|Binge - 4mg Placebo|Non-bulimic controls instruction to binge eat - placebo
448994|NCT00600743|O4|Outcome|Normal_4mg Drug|Eat normally 4 mg dose drug
448995|NCT00600743|O3|Outcome|Normal_2mg Drug|Eat normally 2 mg dose drug
448929|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448930|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448931|NCT00600171|E6|Reported Event|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448932|NCT00600171|E5|Reported Event|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
449010|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449011|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449012|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
448933|NCT00600171|E4|Reported Event|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448934|NCT00600171|E3|Reported Event|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448935|NCT00600171|E2|Reported Event|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448936|NCT00600171|E1|Reported Event|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
448937|NCT00600353|B3|Baseline|Total|Total of all reporting groups
448938|NCT00600353|B2|Baseline|Group B Lymphoma|Includes patients with Hodgkin's Disease and Non-Hodgkin's lymphoma
448939|NCT00600353|B1|Baseline|Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma
Conditioning regimen, over a 7 day period, includes:
Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
Group B: Subjects with Lymphoma
Conditioning regimen, over a 7 day period, includes: (BEAC)
BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
448940|NCT00600353|P2|Participant Flow|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma
Conditioning regimen, over a 7 day period, includes: (BEAC)
carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
448941|NCT00600353|P1|Participant Flow|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma
Conditioning regimen, over a 7 day period, includes:
Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
448942|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma
Conditioning regimen, over a 7 day period, includes: (BEAC)
carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
448943|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma
Conditioning regimen, over a 7 day period, includes:
Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
448944|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma
Conditioning regimen, over a 7 day period, includes: (BEAC)
carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
448945|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma
Conditioning regimen, over a 7 day period, includes:
Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
448946|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma
Conditioning regimen, over a 7 day period, includes: (BEAC)
carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
448947|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma
Conditioning regimen, over a 7 day period, includes:
Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
448996|NCT00600743|O2|Outcome|Normal_1mg Drug|Eat normally 1 mg dose drug
448948|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma
Conditioning regimen, over a 7 day period, includes: (BEAC)
carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
448949|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma
Conditioning regimen, over a 7 day period, includes:
Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
448950|NCT00600353|E2|Reported Event|Patients With Lymphoma|"Group B: Subjects with Lymphoma
Conditioning regimen, over a 7 day period, includes: (BEAC)
BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
449013|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
448951|NCT00600353|E1|Reported Event|Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma
Conditioning regimen, over a 7 day period, includes:
Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
448952|NCT00600613|B1|Baseline|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
448953|NCT00600613|P1|Participant Flow|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
448954|NCT00600613|O1|Outcome|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
448955|NCT00600613|E1|Reported Event|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
448956|NCT00600704|B3|Baseline|Total|Total of all reporting groups
448957|NCT00600704|B2|Baseline|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
448958|NCT00600704|B1|Baseline|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
448959|NCT00600704|P2|Participant Flow|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
448960|NCT00600704|P1|Participant Flow|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
448961|NCT00600704|O2|Outcome|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
448962|NCT00600704|O1|Outcome|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
448963|NCT00600704|E2|Reported Event|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
448964|NCT00600704|E1|Reported Event|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
448965|NCT00600743|B5|Baseline|Total|Total of all reporting groups
448966|NCT00600743|B4|Baseline|4 MG CCK AGONIST BINGE EATING|Healthy/normal control participants were given both the 4 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to binge eat as much as they could.
448967|NCT00600743|B3|Baseline|4 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 4mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
448968|NCT00600743|B2|Baseline|2 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 2 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
448969|NCT00600743|B1|Baseline|1 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 1 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
448970|NCT00600743|P4|Participant Flow|4 MG CCK AGONIST BINGE EATING|Healthy/normal control participants were given both the 4 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to binge eat as much as they could.
448971|NCT00600743|P3|Participant Flow|4 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 4mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
448972|NCT00600743|P2|Participant Flow|2 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 2 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
448973|NCT00600743|P1|Participant Flow|1 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 1 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
448974|NCT00600743|O8|Outcome|Normal_4 mg Dose Placebo|Eat normally 4 mg dose placebo
448975|NCT00600743|O7|Outcome|Normal_2 mg Dose Placebo|Eat normally 2 mg dose placebo
448976|NCT00600743|O6|Outcome|Normal 1 mg Dose Placebo|Eat normally 1 mg dose placebo
448977|NCT00600743|O5|Outcome|Binge - 4mg Placebo|Non-bulimic controls instruction to binge eat - placebo
448978|NCT00600743|O4|Outcome|Normal_4mg Drug|Eat normally 4 mg dose drug
448979|NCT00600743|O3|Outcome|Normal_2mg Drug|Eat normally 2 mg dose drug
448980|NCT00600743|O2|Outcome|Normal_1mg Drug|Eat normally 1 mg dose drug
448981|NCT00600743|O1|Outcome|Binge_4mg Drug|Non-bulimic controls Instruction to binge eat (7 subjects) drug
448982|NCT00600743|O8|Outcome|Normal_4mg Placebo|Normal_4mg_dose placebo
448983|NCT00600743|O7|Outcome|Normal 2mg_placebo|Normal 2mg_dose_placebo
448997|NCT00600743|O1|Outcome|Binge_4mg Drug|Non-bulimic controls Instruction to binge eat (7 subjects) drug
448998|NCT00600743|E1|Reported Event|Normal|Normal control group
448999|NCT00600756|B3|Baseline|Total|Total of all reporting groups
449000|NCT00600756|B2|Baseline|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
449001|NCT00600756|B1|Baseline|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449002|NCT00600756|P2|Participant Flow|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
449003|NCT00600756|P1|Participant Flow|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449004|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449005|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449006|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449007|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449014|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449015|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449016|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449017|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449018|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449019|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449020|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449021|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449022|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449023|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449024|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449025|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449026|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449027|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449028|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449029|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449030|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449031|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449032|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449033|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449034|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449035|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449036|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449037|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449038|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449039|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449040|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449041|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449042|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449043|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449044|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449045|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449046|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449047|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449048|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449049|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449050|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449051|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449052|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449053|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449054|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449055|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449056|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449057|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449058|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449059|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449060|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449061|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449062|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449063|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449064|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
449065|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449066|NCT00600756|E2|Reported Event|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
449067|NCT00600756|E1|Reported Event|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
449068|NCT00600821|B3|Baseline|Total|Total of all reporting groups
449069|NCT00600821|B2|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449123|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
449070|NCT00600821|B1|Baseline|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449071|NCT00600821|P2|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kilogram (mg/kg) infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449072|NCT00600821|P1|Participant Flow|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) along with infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin area under the concentration-time curve (AUC) of 6 mg*minute/milliliter (mg*min/mL) infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449073|NCT00600821|O2|Outcome|Bevacizumab+ Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.
449074|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.
449075|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449076|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449077|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449078|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449079|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449080|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449081|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449120|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
449082|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449083|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449084|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449183|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
449412|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449085|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449086|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449087|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449088|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449089|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449090|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449091|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449092|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449093|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449094|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449095|NCT00600821|E2|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
449096|NCT00600821|E1|Reported Event|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
449097|NCT00600886|B3|Baseline|Total|Total of all reporting groups
449098|NCT00600886|B2|Baseline|Octreotide LAR|Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
449175|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
449099|NCT00600886|B1|Baseline|Pasireotide LAR|Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
449100|NCT00600886|P2|Participant Flow|Octreotide LAR|Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
449184|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449101|NCT00600886|P1|Participant Flow|Pasireotide LAR|Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
449102|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
449103|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
449104|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
449105|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
449106|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
449107|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
449108|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
449109|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
449110|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
449111|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
449112|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
449113|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
449114|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
449115|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
449116|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
449117|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
449118|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
449119|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
450238|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
449121|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
449122|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
449124|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
449125|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
449126|NCT00600886|O3|Outcome|Octreotide LAR 30 mg|Patients in this arm received Octreotide LAR 30 mg injection prior to PK sample collection.
449127|NCT00600886|O2|Outcome|Octreotide LAR 20 mg|Patients in this arm received Octreotide LAR 20 mg injection prior to PK sample collection.
449128|NCT00600886|O1|Outcome|Octreotide LAR 10mg|Patients in this arm received Octreotide LAR 10 mg injection prior to PK sample collection.
449129|NCT00600886|O3|Outcome|Pasireotide LAR 60mg|Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
449130|NCT00600886|O2|Outcome|Pasireotide LAR 40 mg|Patients in this arm received Pasireotide LAR 40 mg injection prior to PK sample collection.
449131|NCT00600886|O1|Outcome|Pasireotide LAR 20 mg|Patients in this arm received Pasireotide LAR 20 mg injection prior to PK sample collection.
449132|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
449133|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
449134|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
449135|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
449136|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
449137|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
449138|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
449139|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
449140|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
449141|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
449142|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
449143|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
449173|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
451146|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
449144|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
449145|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
449146|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
449181|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449147|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
449148|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
449149|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
449150|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
449151|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
449152|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
449153|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
449154|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
449155|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
449156|NCT00600886|E6|Reported Event|Crossed Over to Pasireotide LAR - up to EOS|"Includes all data in the extension phase (up to End-of-study date of 11-Mar-2016) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.
Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26."
449157|NCT00600886|E5|Reported Event|Pasireotide LAR - up to EOS|"Includes data from both core and extension phase (up to End-of-study date of 11-Mar-2016) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.
Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26."
449158|NCT00600886|E4|Reported Event|Crossed Over to Octreotide LAR - up to 26 Months|Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Pasireotide LAR in the core to Octreotide LAR treatment in the extension phase.
449159|NCT00600886|E3|Reported Event|Crossed Over to Pasireotide LAR - up to 26 Months|Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.
449160|NCT00600886|E2|Reported Event|Octreotide LAR - up to 26 Months|Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment, only data collected before crossover is included.
449161|NCT00600886|E1|Reported Event|Pasireotide LAR - up to 26 Months|Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.
449162|NCT00600938|B3|Baseline|Total|Total of all reporting groups
449163|NCT00600938|B2|Baseline|Core: Deferoxamine (DFO)|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449164|NCT00600938|B1|Baseline|Core: Deferasirox (ICL)|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449165|NCT00600938|P4|Participant Flow|ICL to DFO (Deferasirox to Deferoxamine)|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
449166|NCT00600938|P3|Participant Flow|DFO to ICL (Deferoxamine to Deferasirox)|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
449167|NCT00600938|P2|Participant Flow|Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449168|NCT00600938|P1|Participant Flow|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449169|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449170|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
449171|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
449172|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449174|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
449176|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449177|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449178|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
449179|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
449180|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449182|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
449185|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449186|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
449187|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
449188|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449189|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449190|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
449191|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
449192|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449193|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449194|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
449195|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
449196|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449197|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449198|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
449199|NCT00600938|O3|Outcome|Extension; DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
449200|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449201|NCT00600938|O1|Outcome|Extension : ICL to ICL|Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449202|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449203|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449204|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449205|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
449206|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449207|NCT00600938|O2|Outcome|Core; Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
449208|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
449209|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
449210|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
449211|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449212|NCT00600938|O1|Outcome|Core; Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
449213|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
449214|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
449215|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
449216|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
449217|NCT00600938|O2|Outcome|Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449218|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
449219|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
449296|NCT00606905|O2|Outcome|Normal Saline|equivalent volume of normal saline
449220|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
449221|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO)|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 months.
449222|NCT00600938|O1|Outcome|Core: Deferasirox (ICL)|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 months.
449223|NCT00600938|E6|Reported Event|Extension Phase - ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
449224|NCT00600938|E5|Reported Event|Extension Phase - DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
449225|NCT00600938|E4|Reported Event|Extension Phase - DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449226|NCT00600938|E3|Reported Event|Extension Phase - ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449227|NCT00600938|E2|Reported Event|Core Phase - DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
449228|NCT00600938|E1|Reported Event|Core Phase - ICL670|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
449229|NCT00601107|B5|Baseline|Total|Total of all reporting groups
449230|NCT00601107|B4|Baseline|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
449231|NCT00601107|B3|Baseline|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
449232|NCT00601107|B2|Baseline|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
449233|NCT00601107|B1|Baseline|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
449234|NCT00601107|P4|Participant Flow|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
449235|NCT00601107|P3|Participant Flow|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
449236|NCT00601107|P2|Participant Flow|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
449237|NCT00601107|P1|Participant Flow|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
449238|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
449239|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
449240|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
449241|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
449242|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
449243|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
449244|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
449245|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
449246|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
449247|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
449248|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
449249|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
449250|NCT00601107|E4|Reported Event|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
449251|NCT00601107|E3|Reported Event|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
449252|NCT00601107|E2|Reported Event|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
449253|NCT00601107|E1|Reported Event|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
449254|NCT00601146|B1|Baseline|Low-dose CT Screening|Annual low-dose chest CT screening
449255|NCT00601146|P1|Participant Flow|Low-dose CT Screening|Annual low-dose chest CT screening
449256|NCT00601146|O1|Outcome|Low-dose CT Screening|Annual low-dose chest CT screening
449257|NCT00601146|E1|Reported Event|Low-dose CT Screening|Annual low-dose chest CT screening
449258|NCT00606892|B1|Baseline|Entire Study Population|Includes all subjects who completed the study. (The total number of subjects who were enrolled in both arms of the study.)
449259|NCT00606892|P2|Participant Flow|Varenicline First, Then Placebo|Subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).After a minimum of washout period of 5 days, then subjects received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg).
449260|NCT00606892|P1|Participant Flow|Placebo First, Then Varenicline|Subject received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg). After a minimum washout period of 5 days,then subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).
449261|NCT00606892|O6|Outcome|Varenicline / High Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the varenicline condition.
449262|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the varenicline condition.
449263|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the varenicline condition.
449264|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the placebo condition.
449265|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the placebo condition.
449266|NCT00606892|O1|Outcome|Placebo / Low Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the placebo condition.
449267|NCT00606892|O6|Outcome|Varenicline / High Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the varenicline condition.
449268|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the varenicline condition.
449269|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.1mg per 70kg) infusion under the varenicline condition.
449270|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the placebo condition.
449271|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the placebo condition.
449272|NCT00606892|O1|Outcome|Placebo / Low Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.1mg per70kg) infusion under the placebo condition.
449273|NCT00606892|O6|Outcome|Varenicline/ High Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the varenicline condition.
449274|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the varenicline condition.
449275|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the varenicline condition.
449276|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the placebo condition.
449277|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the placebo condition.
449278|NCT00606892|O1|Outcome|Placebo/ Low Dose Nictoine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the placebo condition.
449279|NCT00606892|O2|Outcome|Varenicline (1 mg)|The mean cotinine levels for subjects under the varenicline condition.
449280|NCT00606892|O1|Outcome|Placebo|The mean cotinine levels for subjects under the placebo condition.
449281|NCT00606892|O4|Outcome|Varenicline, Post-Nicotine|Mean reaction time during modified Stroop task under the varenicline condition and 30 minutes after the nicotine infusions.
449282|NCT00606892|O3|Outcome|Varenicline, Pre-Nicotine|Mean reaction time during modified Stroop task under the varenicline condition prior to the nicotine infusions.
449283|NCT00606892|O2|Outcome|Placebo, Post-Nicotine|Mean reaction time during modified Stroop task under the placebo condition and 30 minutes after the nicotine infusions.
449284|NCT00606892|O1|Outcome|Placebo, Pre-Nicotine|Mean reaction time during modified Stroop task under the placebo condition and prior to the nicotine infusions.
449285|NCT00606892|E6|Reported Event|Varenicline First, Then Placebo, Second Intervention|Subjects crossed-over from the first intervention (varenicline) and received placebo once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
449286|NCT00606892|E5|Reported Event|Placebo First, Then Varenicline, Second Intervention|Subjects crossed-over from the first intervention and received varenicline once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
449287|NCT00606892|E4|Reported Event|Adaptation - Varenicline First, Then Placebo|Subjects randomized to the 'Varenicline first' condition first received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability before receiving the study medication.
449288|NCT00606892|E3|Reported Event|Adaptation - Placebo First, Then Varenicline|Subjects randomized to the 'Placebo first' condition participated in a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability prior to the study medication intervention.
451147|NCT00616655|O1|Outcome|Placebo Arm|Placebo
449289|NCT00606892|E2|Reported Event|Varenicline First, Then Placebo, First Intervention|Subjects received varenicline once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
449290|NCT00606892|E1|Reported Event|Placebo First, Then Varenicline, First Intervention|Subjects received a placebo tablet once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
449291|NCT00606905|B3|Baseline|Total|Total of all reporting groups
449292|NCT00606905|B2|Baseline|Normal Saline|equivalent volume of normal saline
449293|NCT00606905|B1|Baseline|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
449294|NCT00606905|P2|Participant Flow|Normal Saline|equivalent volume of normal saline
449295|NCT00606905|P1|Participant Flow|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
449297|NCT00606905|O1|Outcome|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
449298|NCT00606905|E2|Reported Event|Normal Saline|equivalent volume of normal saline
449299|NCT00606905|E1|Reported Event|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
449300|NCT00606931|B1|Baseline|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
449301|NCT00606931|P1|Participant Flow|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
449302|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
449303|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
449304|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
449305|NCT00606931|E1|Reported Event|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
449306|NCT00606944|B3|Baseline|Total|Total of all reporting groups
449307|NCT00606944|B2|Baseline|ERP Group|Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
449308|NCT00606944|B1|Baseline|Control Group|traditional, conventional care group
449309|NCT00606944|P2|Participant Flow|ERP Group|Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
449310|NCT00606944|P1|Participant Flow|Control Group|traditional, conventional care group
449311|NCT00606944|O2|Outcome|ERP Group|Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
449312|NCT00606944|O1|Outcome|Control Group|traditional, conventional care group
449313|NCT00606944|E2|Reported Event|ERP Group|Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
449314|NCT00606944|E1|Reported Event|Control Group|traditional, conventional care group
449315|NCT00607048|B3|Baseline|Total|Total of all reporting groups
449316|NCT00607048|B2|Baseline|Schedule B - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
449317|NCT00607048|B1|Baseline|Schedule A - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
449318|NCT00607048|P6|Participant Flow|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
449319|NCT00607048|P5|Participant Flow|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
455428|NCT00614939|O1|Outcome|Placebo|Placebo
449320|NCT00607048|P4|Participant Flow|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449321|NCT00607048|P3|Participant Flow|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
449322|NCT00607048|P2|Participant Flow|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449323|NCT00607048|P1|Participant Flow|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449324|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449325|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449326|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449327|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449328|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449329|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449330|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449331|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449332|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449333|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449334|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449335|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449336|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449337|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449338|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449339|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449409|NCT00607087|P2|Participant Flow|Sequence 2|insulin aspart / insulin lispro / insulin glulisine
449410|NCT00607087|P1|Participant Flow|Sequence 1|insulin glulisine / insulin aspart / insulin lispro
449411|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449340|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449341|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449342|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449343|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449344|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449345|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449346|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449347|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449348|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449349|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449350|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449351|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449352|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449353|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
451380|NCT00617175|O2|Outcome|NID 30/40|Prolonged number of interval to detect ventricular arrhythmias
449354|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449355|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449356|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449357|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449358|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449359|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449360|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449361|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449362|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449363|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449364|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449365|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449366|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449367|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449368|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449369|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449385|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449370|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449371|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449372|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449373|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449374|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449375|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449376|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449377|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449378|NCT00607048|O2|Outcome|Schedule B - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
449379|NCT00607048|O1|Outcome|Schedule A - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
449380|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449381|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449382|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449383|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449384|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449386|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449387|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449388|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449389|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449390|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449391|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449392|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
449393|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449394|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449395|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
449396|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449397|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449398|NCT00607048|E6|Reported Event|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
449399|NCT00607048|E5|Reported Event|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449400|NCT00607048|E4|Reported Event|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
449401|NCT00607048|E3|Reported Event|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
449450|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449451|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449402|NCT00607048|E2|Reported Event|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
449403|NCT00607048|E1|Reported Event|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
449404|NCT00607087|B4|Baseline|Total|Total of all reporting groups
449405|NCT00607087|B3|Baseline|Sequence 3|insulin lispro / insulin glulisine / insulin aspart
449406|NCT00607087|B2|Baseline|Sequence 2|insulin aspart / insulin lispro / insulin glulisine
449407|NCT00607087|B1|Baseline|Sequence 1|insulin glulisine / insulin aspart / insulin lispro
449408|NCT00607087|P3|Participant Flow|Sequence 3|insulin lispro / insulin glulisine / insulin aspart
449413|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449414|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449415|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449416|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449417|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449418|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449419|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449420|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449421|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449422|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449423|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449424|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449425|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449426|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449427|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449428|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449429|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449430|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449431|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449432|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449433|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449434|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449435|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449436|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449437|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449438|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449439|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449440|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449441|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449442|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449443|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449444|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449445|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449446|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449447|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449448|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449449|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449452|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449453|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449454|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449455|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449456|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449457|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449458|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449459|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449460|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449461|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449462|NCT00607087|E3|Reported Event|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449463|NCT00607087|E2|Reported Event|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449464|NCT00607087|E1|Reported Event|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
449465|NCT00607113|B3|Baseline|Total|Total of all reporting groups
449466|NCT00607113|B2|Baseline|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
449467|NCT00607113|B1|Baseline|Avastin|Cycle 1: (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV), Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
449468|NCT00607113|P2|Participant Flow|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
449469|NCT00607113|P1|Participant Flow|Avastin|Cycle 1: (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV), Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
449470|NCT00607113|O2|Outcome|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
449471|NCT00607113|O1|Outcome|Avastin|Cycle 1 (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV) or RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
449472|NCT00607113|E1|Reported Event|Avastin + RAD001|One agent (RAD001 or Avastin) then adding the second agent (Avastin or RAD001): Avastin 15 mg/kg intravenous (IV) every 3 weeks + RAD001 10 mg orally daily for 21 Days
449473|NCT00607126|B3|Baseline|Total|Total of all reporting groups
449474|NCT00607126|B2|Baseline|Resistive Training|"resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
449475|NCT00607126|B1|Baseline|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
449476|NCT00607126|P2|Participant Flow|Resistive Training|"resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
449477|NCT00607126|P1|Participant Flow|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
449478|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
449490|NCT00611325|B1|Baseline|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449479|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
449480|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
449496|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449481|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
449482|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
449483|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
449484|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
449485|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
449486|NCT00607126|E2|Reported Event|Resistive Training|"resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
449487|NCT00607126|E1|Reported Event|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
449488|NCT00611325|B3|Baseline|Total|Total of all reporting groups
449489|NCT00611325|B2|Baseline|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449530|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
449491|NCT00611325|P2|Participant Flow|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449492|NCT00611325|P1|Participant Flow|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449493|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449494|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449495|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449497|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449498|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449499|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449500|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449501|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449502|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
449503|NCT00611325|E2|Reported Event|Non-EIAED|"Avastin: Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.
Bortezomib: Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 1.7 mg/m2 for patients not taking EIAEDs."
449504|NCT00611325|E1|Reported Event|EIAED|"Avastin: Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.
Bortezomib: Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 2.5 mg/m2 for patients taking EIAEDs."
449505|NCT00611403|B3|Baseline|Total|Total of all reporting groups
449506|NCT00611403|B2|Baseline|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
449507|NCT00611403|B1|Baseline|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
449508|NCT00611403|P2|Participant Flow|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
449509|NCT00611403|P1|Participant Flow|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
449510|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
449511|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
449512|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
449513|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
449514|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
449515|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
449516|NCT00611403|E2|Reported Event|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
449517|NCT00611403|E1|Reported Event|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
449518|NCT00611442|B3|Baseline|Total|Total of all reporting groups
449519|NCT00611442|B2|Baseline|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
449520|NCT00611442|B1|Baseline|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
449521|NCT00611442|P2|Participant Flow|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
449522|NCT00611442|P1|Participant Flow|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
449523|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
449524|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
449525|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
449526|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
449527|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
449528|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
449529|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
451381|NCT00617175|O1|Outcome|NID 18/24|standard number of interval to detect ventricular arrhythmias
449531|NCT00611442|E2|Reported Event|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
449532|NCT00611442|E1|Reported Event|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
449533|NCT00611455|B3|Baseline|Total|Total of all reporting groups
449534|NCT00611455|B2|Baseline|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449535|NCT00611455|B1|Baseline|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449536|NCT00611455|P3|Participant Flow|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449615|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449537|NCT00611455|P2|Participant Flow|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449538|NCT00611455|P1|Participant Flow|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449539|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449540|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449541|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449542|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449543|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449544|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449545|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449546|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449547|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449548|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449829|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449549|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449550|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449551|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449552|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449553|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449554|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449555|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449556|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449557|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449558|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449559|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449560|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449561|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449562|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449563|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449704|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449564|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449565|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449566|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449567|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449568|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449569|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449570|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449571|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449572|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449573|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449574|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449575|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449576|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449577|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449578|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449705|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449579|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449580|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449581|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449582|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449583|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449584|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449585|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449586|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449587|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449588|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449589|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449590|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449591|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449592|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449593|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449706|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449594|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449595|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449596|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449597|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449598|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449599|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449600|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449601|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449602|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449603|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449604|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449605|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449606|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449607|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449608|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449609|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449830|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449610|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449611|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449612|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449613|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449614|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449616|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449617|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449618|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449619|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449620|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449621|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449622|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449623|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449624|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449625|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449626|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449627|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449628|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449629|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449630|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449631|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449632|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449633|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449634|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449831|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449635|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449636|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449637|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449638|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449639|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449640|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449641|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449642|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449643|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449644|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449645|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449646|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449647|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449648|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449649|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449650|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449651|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449652|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449653|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449654|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449655|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449656|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449657|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449658|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
449659|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
452372|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
449660|NCT00611455|E3|Reported Event|Placebo or Ofatumumab 700 mg: Follow-up Period|SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
449661|NCT00611455|E2|Reported Event|Ofatumumab 700 mg: DB and OL Periods|SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
449716|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449717|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449662|NCT00611455|E1|Reported Event|Placebo: DB Period|Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
449663|NCT00611468|B1|Baseline|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
449664|NCT00611468|P4|Participant Flow|PK Group for Additional PK Data|Additional patients were enrolled for enhanced PK parameter estimation
449665|NCT00611468|P3|Participant Flow|Dosage Level 3 for MTD Determination|Dosage level 3 was topotecan 1.25 mg/m2 and erlotinib 150 mg.
449666|NCT00611468|P2|Participant Flow|Dosage Level 2 for MTD Determination|Dosage level 2 was topotecan 1.0 mg/m2 and erlotinib 150 mg.
449667|NCT00611468|P1|Participant Flow|Dosage Level 1 for MTD Determination|Dosage level 1 was topotecan 0.75 mg/m2 and erlotinib 150 mg.
449668|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
449669|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
449670|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
449671|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
449672|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
449673|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
449674|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
449675|NCT00611468|E1|Reported Event|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
449707|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449708|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449676|NCT00611533|B1|Baseline|All Study Participants|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
449677|NCT00611533|P2|Participant Flow|Placebo Then Atomoxetine|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
449678|NCT00611533|P1|Participant Flow|Atomoxetine Then Placebo|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
449679|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449680|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449681|NCT00611533|O1|Outcome|Baseline|
449682|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449683|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449684|NCT00611533|O1|Outcome|Baseline|
449685|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449686|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449687|NCT00611533|O1|Outcome|Baseline|
449688|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449689|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449690|NCT00611533|O1|Outcome|Baseline|
449691|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449692|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449693|NCT00611533|O1|Outcome|Baseline|
449694|NCT00611533|E2|Reported Event|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449695|NCT00611533|E1|Reported Event|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
449696|NCT00611559|B4|Baseline|Total|Total of all reporting groups
449697|NCT00611559|B3|Baseline|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449698|NCT00611559|B2|Baseline|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449699|NCT00611559|B1|Baseline|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449700|NCT00611559|P3|Participant Flow|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449701|NCT00611559|P2|Participant Flow|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449702|NCT00611559|P1|Participant Flow|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449703|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449709|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449710|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449711|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449712|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449713|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449714|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449715|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
450495|NCT00613106|B1|Baseline|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
449718|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449719|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449720|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449721|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449722|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449723|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449724|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449725|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449726|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449727|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449728|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449729|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449730|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449731|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449732|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449733|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449734|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449735|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449736|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449737|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449738|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449739|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449740|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449741|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449742|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449743|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449744|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449745|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449746|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449747|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449748|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449749|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449750|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449751|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449752|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449753|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449754|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449755|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449756|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449757|NCT00611559|E3|Reported Event|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
449758|NCT00611559|E2|Reported Event|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
449759|NCT00611559|E1|Reported Event|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
449760|NCT00611624|B1|Baseline|Five Days of Mammosite Therapy|
449761|NCT00611624|P1|Participant Flow|Five Days of Mammosite Therapy|Five Days of Mammosite Therapy (Radiotherapy)
449762|NCT00611624|O1|Outcome|Patient Characteristics|Twenty-eight women in total were enrolled and had been treated on this trial at the time of analysis (12 additional patients accrued after the initial phase of 16 patients).
449763|NCT00611624|O1|Outcome|Five Days of Mammosite Therapy|
449764|NCT00611624|E1|Reported Event|Five Days of Mammosite Therapy|
449765|NCT00611715|B3|Baseline|Total|Total of all reporting groups
449766|NCT00611715|B2|Baseline|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
449767|NCT00611715|B1|Baseline|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
449768|NCT00611715|P2|Participant Flow|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
449769|NCT00611715|P1|Participant Flow|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
449770|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients that had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
449771|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients that were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
449772|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients that had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy
449773|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients that were endocrine treatment-naive in the metastatic setting and more than 12 months from adjuvant endocrine therapy
449774|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
449775|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
449776|NCT00611715|O2|Outcome|Previous Hormone Therapy|Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
449777|NCT00611715|O1|Outcome|Hormone Therapy Naive|Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
449778|NCT00611715|E2|Reported Event|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
449779|NCT00611715|E1|Reported Event|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
449780|NCT00611767|B3|Baseline|Total|Total of all reporting groups
449781|NCT00611767|B2|Baseline|Family History Positive for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). Biological father and another first or second-degree biological relative with a history of alcoholism by Family History Assessment Module (FHAM) developed by COGA.
449782|NCT00611767|B1|Baseline|Family History Negative for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). No family history of alcoholism in any first or second-degree relatives.
449826|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449827|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449828|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449783|NCT00611767|P2|Participant Flow|Family History Positive for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). Biological father and another first or second-degree biological relative with a history of alcoholism by Family History Assessment Module (FHAM) developed by The Collaborative Study on the Genetics of Alcoholism (COGA).
449784|NCT00611767|P1|Participant Flow|Family History Negative for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). No family history of alcoholism in any first or second-degree relatives.
449785|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449786|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449787|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449788|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449789|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449790|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449791|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449792|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449793|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449794|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449795|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449796|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449797|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449798|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449799|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449800|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449801|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449802|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449803|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449804|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449805|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449806|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449807|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449808|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449809|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449810|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449811|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449812|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449813|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449814|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449815|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449816|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449817|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449818|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449819|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449820|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449821|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449822|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449823|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449824|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449825|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
455429|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
449832|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449833|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449834|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449835|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449836|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449837|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449838|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449839|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449840|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449841|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449842|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449843|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449844|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449845|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449846|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449847|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449848|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449849|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449850|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449851|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449852|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449853|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449854|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449855|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449856|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449857|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449858|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449859|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449860|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449861|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449862|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449863|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449864|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449865|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449866|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449867|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449868|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449869|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449870|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449871|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449872|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449873|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449874|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449875|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449876|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449877|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449878|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449879|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449880|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
455430|NCT00614939|O1|Outcome|Placebo|Placebo
449881|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449882|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449883|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449884|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449885|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449886|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449887|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449888|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449889|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449890|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449891|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449892|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449893|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449894|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449895|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449896|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449897|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449898|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449899|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449900|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449901|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449902|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449903|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449904|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449905|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449906|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449907|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449908|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449909|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449910|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449911|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449912|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449913|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449914|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449915|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449916|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449917|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449918|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449919|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449920|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449921|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449922|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449923|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449924|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449925|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449926|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449927|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449928|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449929|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
452373|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
449930|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449931|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449932|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449933|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449934|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449935|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449936|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449937|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449938|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449939|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
449940|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
449941|NCT00611767|E2|Reported Event|Family History Positive for Alcoholism|"Family History Positive for Alcoholism subjects will receive 2 interventions
Placebo: A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion)."
449942|NCT00611767|E1|Reported Event|Family History Negative for Alcoholism|"Family History Negative for Alcoholism subjects will receive 2 interventions
Thiopental: A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion)."
449943|NCT00611806|B3|Baseline|Total|Total of all reporting groups
449944|NCT00611806|B2|Baseline|Placebo|"Participants will take placebo for 18 weeks.
Placebo: 1 capsule po daily"
449945|NCT00611806|B1|Baseline|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.
Folic Acid: Folic acid 2mg po daily
B12: B12 400 micrograms po daily"
449946|NCT00611806|P2|Participant Flow|Placebo|"Participants will take placebo for 18 weeks.
Placebo: 1 capsule po daily"
449947|NCT00611806|P1|Participant Flow|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.
Folic Acid: Folic acid 2mg po daily
B12: B12 400 micrograms po daily"
449948|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.
Placebo: 1 capsule po daily"
449949|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.
Folic Acid: Folic acid 2mg po daily
B12: B12 400 micrograms po daily"
449950|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.
Placebo: 1 capsule po daily"
449951|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.
Folic Acid: Folic acid 2mg po daily
B12: B12 400 micrograms po daily"
449952|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.
Placebo: 1 capsule po daily"
449953|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.
Folic Acid: Folic acid 2mg po daily
B12: B12 400 micrograms po daily"
449954|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.
Placebo: 1 capsule po daily"
449955|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.
Folic Acid: Folic acid 2mg po daily
B12: B12 400 micrograms po daily"
449956|NCT00611806|E2|Reported Event|Placebo|"Participants will take placebo for 18 weeks.
Placebo: 1 capsule po daily"
449957|NCT00611806|E1|Reported Event|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.
Folic Acid: Folic acid 2mg po daily
B12: B12 400 micrograms po daily"
449958|NCT00611884|B5|Baseline|Total|Total of all reporting groups
449959|NCT00611884|B4|Baseline|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449960|NCT00611884|B3|Baseline|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
449961|NCT00611884|B2|Baseline|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449962|NCT00611884|B1|Baseline|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
449963|NCT00611884|P4|Participant Flow|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449964|NCT00611884|P3|Participant Flow|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
449965|NCT00611884|P2|Participant Flow|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450037|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
455431|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
449966|NCT00611884|P1|Participant Flow|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
449967|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449968|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
449969|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450108|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
449970|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
449971|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449972|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
449973|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449974|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
449975|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449976|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
449977|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449978|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
449979|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449980|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
449981|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449982|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
449983|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449984|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
449985|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449986|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
449987|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449988|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
449989|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449990|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
449991|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449992|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
449993|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449994|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
449995|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449996|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
449997|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
449998|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
449999|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450000|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
450001|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450002|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
450003|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450004|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
450005|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450006|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
450007|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450008|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
450038|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
453510|NCT00619151|O1|Outcome|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
450009|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450010|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
450011|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450012|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
450013|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450014|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
450015|NCT00611884|E4|Reported Event|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450016|NCT00611884|E3|Reported Event|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
450017|NCT00611884|E2|Reported Event|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
450018|NCT00611884|E1|Reported Event|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
450019|NCT00611897|B1|Baseline|Overall Sample|This is the group of healthy volunteers that consented to participate in the study.
450020|NCT00611897|P2|Participant Flow|Day 1: Placebo NAC; Day 2: Active NAC|Subjects were randomized to receive PLACEBO NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received ACTIVE NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
450021|NCT00611897|P1|Participant Flow|Day 1: Active NAC; Day 2: Placebo NAC|Subjects were randomized to receive ACTIVE NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received PLACEBO NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
450022|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
450023|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
450024|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
450025|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
450026|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
450027|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
450028|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
450029|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
450030|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
450031|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
450032|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
450033|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
450034|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
450035|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
450036|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
450039|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
450040|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
450041|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
450042|NCT00611897|E2|Reported Event|Day 1: Active NAC; Day 2: Placebo NAC|Subjects were randomized to receive ACTIVE NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received PLACEBO NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
450249|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450496|NCT00613106|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg
450043|NCT00611897|E1|Reported Event|Day 1: Placebo NAC; Day 2: Active NAC|Subjects were randomized to receive PLACEBO NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received ACTIVE NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
450044|NCT00612040|B4|Baseline|Total|Total of all reporting groups
450045|NCT00612040|B3|Baseline|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450046|NCT00612040|B2|Baseline|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450047|NCT00612040|B1|Baseline|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450048|NCT00612040|P3|Participant Flow|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450049|NCT00612040|P2|Participant Flow|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450050|NCT00612040|P1|Participant Flow|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450051|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450052|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450053|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450054|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450055|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450056|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450057|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450058|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450059|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450060|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450061|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450062|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450063|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450064|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450065|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450066|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450250|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450797|NCT00613938|B1|Baseline|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
450067|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450068|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450069|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450070|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450071|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450072|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450073|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450074|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450075|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450076|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450077|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450078|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450079|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450080|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450081|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450082|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450083|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450084|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450085|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450086|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450087|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450229|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450088|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450089|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450090|NCT00612040|E3|Reported Event|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450091|NCT00612040|E2|Reported Event|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450092|NCT00612040|E1|Reported Event|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
450093|NCT00612066|B1|Baseline|Rosiglitazone|Rosiglitazone maleate :
450094|NCT00612066|P1|Participant Flow|Rosiglitazone|Rosiglitazone maleate :
450095|NCT00612066|O1|Outcome|Rosiglitazone|Rosiglitazone maleate :
450096|NCT00612066|E1|Reported Event|Rosiglitazone|Rosiglitazone maleate :
450097|NCT00612105|B3|Baseline|Total|Total of all reporting groups
450098|NCT00612105|B2|Baseline|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450099|NCT00612105|B1|Baseline|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450100|NCT00612105|P2|Participant Flow|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450101|NCT00612105|P1|Participant Flow|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450102|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450103|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450104|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450105|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450106|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450230|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450231|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450232|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450233|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
455432|NCT00614939|O1|Outcome|Placebo|Placebo
450107|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450109|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450110|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450111|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450112|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450113|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450114|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450115|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450116|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450117|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450118|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450155|NCT00612222|E1|Reported Event|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
450119|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450120|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450121|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450122|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450123|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant's MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450124|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450125|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450126|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450127|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450128|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450129|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450130|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450156|NCT00612313|B3|Baseline|Total|Total of all reporting groups
450234|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450235|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450236|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450237|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450131|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450132|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450133|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450134|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450135|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450136|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450137|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450138|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450139|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450140|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450141|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450142|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450223|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450224|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450225|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450226|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450227|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450143|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450144|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450145|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450146|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450147|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450148|NCT00612105|E2|Reported Event|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
450149|NCT00612105|E1|Reported Event|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
450150|NCT00612222|B1|Baseline|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
450151|NCT00612222|P1|Participant Flow|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
450152|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
450153|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
450154|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
450228|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450157|NCT00612313|B2|Baseline|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment
Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.
Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants attended 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
450158|NCT00612313|B1|Baseline|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks
Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
450175|NCT00612339|B1|Baseline|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
450159|NCT00612313|P2|Participant Flow|Continued Medication Plus CBT|"n=75 Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment
Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.
Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
450160|NCT00612313|P1|Participant Flow|Continued Medication Alone|"n=69 Participants will receive antidepressant treatment with fluoxetine for 30 weeks
Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
450161|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.
Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms."
450162|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks."
450163|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.
Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.
Treatment was uncontrolled after week 30."
450164|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.
Treatment was uncontrolled after week 30."
450165|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.
Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.
Treatment was uncontrolled after week 30."
450166|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.
Treatment was uncontrolled after week 30."
450167|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.
Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.
n=75"
450168|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.
n=69"
450169|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment
Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.
Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
450170|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants will receive antidepressant treatment with fluoxetine for 30 weeks
Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
450171|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.
Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms."
450172|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks."
450173|NCT00612313|E2|Reported Event|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.
Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.
N=75"
450174|NCT00612313|E1|Reported Event|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks
Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.
N=69"
450176|NCT00612339|P1|Participant Flow|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
450177|NCT00612339|O1|Outcome|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
450178|NCT00612339|E1|Reported Event|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
450179|NCT00612352|B3|Baseline|Total|Total of all reporting groups
450180|NCT00612352|B2|Baseline|Family History Negative|Subjects with no family history of alcoholism.
450181|NCT00612352|B1|Baseline|Family History Positive|Subjects with a positive family history of alcoholism.
450182|NCT00612352|P2|Participant Flow|Family History Negative|Subjects with no family history of alcoholism.
450183|NCT00612352|P1|Participant Flow|Family History Positive|Subjects with a positive family history of alcoholism.
450184|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450185|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450186|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450187|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450188|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450189|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450190|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450191|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450192|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450193|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450194|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450195|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450196|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450197|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450198|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450199|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450200|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450201|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450202|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450203|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450204|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450205|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450206|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450207|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450208|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450209|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450210|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450211|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450212|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450213|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450214|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450215|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450216|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450217|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450218|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450219|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450220|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450221|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450222|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450239|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450240|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450241|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450242|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450243|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450244|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450245|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450246|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450247|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450248|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450251|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450252|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450253|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450254|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450255|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450256|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450257|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450258|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450259|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450260|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450261|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450262|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450263|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450264|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450265|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450266|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450267|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450268|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450269|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450270|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450271|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450272|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450273|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450274|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450275|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450276|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450277|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450278|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450279|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450280|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450281|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450282|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450283|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450284|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450285|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450286|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450287|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450288|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450289|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450290|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450291|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450292|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
450293|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
450294|NCT00612352|E2|Reported Event|Family History Negative|Subjects with no family history of alcoholism.
450295|NCT00612352|E1|Reported Event|Family History Positive|Subjects with a positive family history of alcoholism.
450296|NCT00612430|B3|Baseline|Total|Total of all reporting groups
450297|NCT00612430|B2|Baseline|Grade IV|
450298|NCT00612430|B1|Baseline|Grade III|
450785|NCT00613925|P2|Participant Flow|Explora Group|Women were randomized to the Explora device for endometrial biopsy
450299|NCT00612430|P2|Participant Flow|Grade IV|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
450300|NCT00612430|P1|Participant Flow|Grade III|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
450301|NCT00612430|O2|Outcome|Grade IV|
450302|NCT00612430|O1|Outcome|Grade III|
450303|NCT00612430|O2|Outcome|Grade IV|
450304|NCT00612430|O1|Outcome|Grade III|
450305|NCT00612430|O2|Outcome|Grade IV|
450306|NCT00612430|O1|Outcome|Grade III|
450307|NCT00612430|O2|Outcome|Grade IV|
450308|NCT00612430|O1|Outcome|Grade III|
450369|NCT00612560|E1|Reported Event|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground"
450309|NCT00612430|O2|Outcome|Grade IV|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
450310|NCT00612430|O1|Outcome|Grade III|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
450311|NCT00612430|E2|Reported Event|Grade IV|
450312|NCT00612430|E1|Reported Event|Grade III|
450313|NCT00612508|B3|Baseline|Total|Total of all reporting groups
450314|NCT00612508|B2|Baseline|NuvaRing|intravaginal contraception
450315|NCT00612508|B1|Baseline|Desogen|oral contraceptive
450316|NCT00612508|P2|Participant Flow|NuvaRing|intravaginal contraception
450317|NCT00612508|P1|Participant Flow|Desogen|oral contraceptive
450318|NCT00612508|O2|Outcome|Intravaginal Ring Contraceptive|nuvaring (ethinyl estradiol & desogestrel) = R (ring)
450319|NCT00612508|O1|Outcome|Oral Contraceptive|Desogen (ethinyl estradiol & desogestrel) = P (pill)
450320|NCT00612508|O2|Outcome|NuvaRing|intravaginal contraception = R (ring)
450321|NCT00612508|O1|Outcome|Desogen|oral contraceptive = P (pill)
450322|NCT00612508|E2|Reported Event|NuvaRing|intravaginal contraception
450323|NCT00612508|E1|Reported Event|Desogen|oral contraceptive
450324|NCT00612534|B5|Baseline|Total|Total of all reporting groups
450325|NCT00612534|B4|Baseline|Placebo NanoTab|
450326|NCT00612534|B3|Baseline|Sufentanil NanoTab 15 Mcg|
450327|NCT00612534|B2|Baseline|Sufentanil NanoTab 10 Mcg|
450328|NCT00612534|B1|Baseline|Sufentanil NanoTab 5 Mcg|
450329|NCT00612534|P4|Participant Flow|Placebo NanoTab|
450330|NCT00612534|P3|Participant Flow|Sufentanil NanoTab 15 Mcg|
450331|NCT00612534|P2|Participant Flow|Sufentanil NanoTab 10 Mcg|
450332|NCT00612534|P1|Participant Flow|Sufentanil NanoTab 5 Mcg|
450333|NCT00612534|O4|Outcome|Placebo NanoTab|
450334|NCT00612534|O3|Outcome|Sufentanil NanoTab 15 Mcg|
450335|NCT00612534|O2|Outcome|Sufentanil NanoTab 10 Mcg|
450336|NCT00612534|O1|Outcome|Sufentanil NanoTab 5 Mcg|
450337|NCT00612534|E4|Reported Event|Placebo NanoTab|
450338|NCT00612534|E3|Reported Event|Sufentanil NanoTab 15 Mcg|
450339|NCT00612534|E2|Reported Event|Sufentanil NanoTab 10 Mcg|
450340|NCT00612534|E1|Reported Event|Sufentanil NanoTab 5 Mcg|
450341|NCT00612560|B5|Baseline|Total|Total of all reporting groups
450342|NCT00612560|B4|Baseline|Arm D - Placebo|"Placebo pill 1 per day
Placebo: Placebo pill 1 per day"
450343|NCT00612560|B3|Baseline|Arm C - Anastrozole|"Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day"
450344|NCT00612560|B2|Baseline|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground"
450345|NCT00612560|B1|Baseline|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground"
450346|NCT00612560|P4|Participant Flow|Arm D - Placebo|"Placebo pill 1 per day
Placebo: Placebo pill 1 per day"
450347|NCT00612560|P3|Participant Flow|Arm C - Anastrozole|"Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day"
450348|NCT00612560|P2|Participant Flow|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground"
450349|NCT00612560|P1|Participant Flow|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground"
450350|NCT00612560|O4|Outcome|Arm D - Placebo|"Placebo pill 1 per day
Placebo: Placebo pill 1 per day"
450351|NCT00612560|O3|Outcome|Arm C - Anastrozole|"Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day"
450352|NCT00612560|O2|Outcome|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground"
450353|NCT00612560|O1|Outcome|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground"
450354|NCT00612560|O4|Outcome|Arm D - Placebo|"Placebo pill 1 per day
Placebo: Placebo pill 1 per day"
450355|NCT00612560|O3|Outcome|Arm C - Anastrozole|"Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day"
450356|NCT00612560|O2|Outcome|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground"
450357|NCT00612560|O1|Outcome|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground"
450358|NCT00612560|O4|Outcome|Arm D - Placebo|"Placebo pill 1 per day
Placebo: Placebo pill 1 per day"
450359|NCT00612560|O3|Outcome|Arm C - Anastrozole|"Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day"
450360|NCT00612560|O2|Outcome|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground"
455433|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
450361|NCT00612560|O1|Outcome|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground"
450362|NCT00612560|O4|Outcome|Arm D - Placebo|"Placebo pill 1 per day
Placebo: Placebo pill 1 per day"
450363|NCT00612560|O3|Outcome|Arm C - Anastrozole|"Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day"
450364|NCT00612560|O2|Outcome|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground"
450365|NCT00612560|O1|Outcome|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground"
450366|NCT00612560|E4|Reported Event|Arm D - Placebo|"Placebo pill 1 per day
Placebo: Placebo pill 1 per day"
450367|NCT00612560|E3|Reported Event|Arm C - Anastrozole|"Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day"
450368|NCT00612560|E2|Reported Event|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground"
450370|NCT00612573|B5|Baseline|Total|Total of all reporting groups
450371|NCT00612573|B4|Baseline|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
450372|NCT00612573|B3|Baseline|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
450373|NCT00612573|B2|Baseline|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
450374|NCT00612573|B1|Baseline|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
450375|NCT00612573|P4|Participant Flow|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
450376|NCT00612573|P3|Participant Flow|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
450377|NCT00612573|P2|Participant Flow|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
450378|NCT00612573|P1|Participant Flow|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
450379|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
450380|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
450381|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
450382|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
450383|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
450384|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
450385|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
450386|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
450387|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
450388|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
450389|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
450390|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
450391|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
450392|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
450393|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
450394|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
450395|NCT00612573|E4|Reported Event|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
450396|NCT00612573|E3|Reported Event|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
450397|NCT00612573|E2|Reported Event|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
450398|NCT00612573|E1|Reported Event|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
450399|NCT00612677|B1|Baseline|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
450400|NCT00612677|P1|Participant Flow|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
450401|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
450402|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
450403|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
450404|NCT00612677|E1|Reported Event|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
450405|NCT00612690|B3|Baseline|Total|Total of all reporting groups
450406|NCT00612690|B2|Baseline|Services As Usual|Referral to nearby community mental heath agencies for clinic-based services where participants received standard care for mental health-related problems.
450407|NCT00612690|B1|Baseline|Links to Learning|Mental health intervention focused on enhancing the predictors of young children's school success
450408|NCT00612690|P2|Participant Flow|Services as Usual|"Participants received treatment as usual and referrals.
Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems."
450445|NCT00613015|B3|Baseline|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
450446|NCT00613015|B2|Baseline|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
450786|NCT00613925|P1|Participant Flow|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
450409|NCT00612690|P1|Participant Flow|Links to Learning|"Participants underwent the community mental health consultation model program.
Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning."
450410|NCT00612690|O2|Outcome|Services as Usual|"Participants received treatment as usual and referrals.
Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems."
450452|NCT00613015|P2|Participant Flow|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
450453|NCT00613015|P1|Participant Flow|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
450454|NCT00613015|O6|Outcome|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
450411|NCT00612690|O1|Outcome|Links to Learning|"Participants underwent the community mental health consultation model program.
Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focuses on the strongest teacher and parent predictors of student learning."
450412|NCT00612690|O2|Outcome|Services as Usual|"Participants received treatment as usual and referrals.
Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services where participants received standard care for mental health-related problems."
450413|NCT00612690|O1|Outcome|Links to Learning|"Participants underwent the community mental health consultation model program.
Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning."
450414|NCT00612690|E2|Reported Event|Services as Usual|"Participants will receive treatment as usual and referrals.
Treatment as usual (TAU) : TAU includes referral to community mental health clinic-based services, where participants will receive standard care for mental health-related problems."
450415|NCT00612690|E1|Reported Event|Links to Learning|"Participants will undergo the community mental health consultation model program.
Community mental health consultation model program : The community mental health consultation model program includes collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focuses on the strongest teacher and parent predictors of student learning."
450416|NCT00612807|B3|Baseline|Total|Total of all reporting groups
450417|NCT00612807|B2|Baseline|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
450418|NCT00612807|B1|Baseline|Semi-weekly Medication Management|Medication management with a study doctor every other week.
450419|NCT00612807|P2|Participant Flow|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
450420|NCT00612807|P1|Participant Flow|Semi-weekly Medication Management|Medication management with a study doctor every other week.
450421|NCT00612807|O2|Outcome|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
450422|NCT00612807|O1|Outcome|Semi-weekly Medication Management|Medication management with a study doctor every other week.
450423|NCT00612807|O2|Outcome|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
450424|NCT00612807|O1|Outcome|Semi-weekly Medication Management|Medication management with a study doctor every other week.
450425|NCT00612807|E2|Reported Event|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
450426|NCT00612807|E1|Reported Event|Semi-weekly Medication Management|Medication management with a study doctor every other week.
450427|NCT00612924|B3|Baseline|Total|Total of all reporting groups
450428|NCT00612924|B2|Baseline|ONE-LOK|
450429|NCT00612924|B1|Baseline|Anaconda|The original protocol identified that the Anaconda™ Stent Graft System would be used throughout the current Phase II study. However, a modified device design became available during the course of the current Phase II study and is called the ONELOK™ Stent Graft System. As the modifications to the device design are considered minor, there are no expected differences in the anticipated safety or effectiveness of the device. The design changes relate primary to a uni-docking zone in the bifurcate body to maximize sizing compatibilities between the bifurcate body and the iliac limbs.
450430|NCT00612924|P2|Participant Flow|ONE-LOK|
450431|NCT00612924|P1|Participant Flow|Anaconda|
450432|NCT00612924|O2|Outcome|ONE LOK|
450433|NCT00612924|O1|Outcome|Anaconda|
450434|NCT00612924|O3|Outcome|Total|
450435|NCT00612924|O2|Outcome|ONE LOK|
450436|NCT00612924|O1|Outcome|Anaconda|
450437|NCT00612924|O2|Outcome|ONE LOK|
450438|NCT00612924|O1|Outcome|Anaconda|
450439|NCT00612924|E2|Reported Event|ONE-LOK|
450440|NCT00612924|E1|Reported Event|Anaconda|
450441|NCT00613015|B7|Baseline|Total|Total of all reporting groups
450442|NCT00613015|B6|Baseline|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
450443|NCT00613015|B5|Baseline|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
450444|NCT00613015|B4|Baseline|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
453511|NCT00619151|E2|Reported Event|St.Jude Valve|St. Jude Medical Regent Valve
450447|NCT00613015|B1|Baseline|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
450448|NCT00613015|P6|Participant Flow|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
450449|NCT00613015|P5|Participant Flow|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
450450|NCT00613015|P4|Participant Flow|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
450451|NCT00613015|P3|Participant Flow|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
450455|NCT00613015|O5|Outcome|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
450456|NCT00613015|O4|Outcome|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
450457|NCT00613015|O3|Outcome|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
450458|NCT00613015|O2|Outcome|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
450459|NCT00613015|O1|Outcome|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
450460|NCT00613015|O6|Outcome|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
450461|NCT00613015|O5|Outcome|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
450462|NCT00613015|O4|Outcome|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
450463|NCT00613015|O3|Outcome|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
450464|NCT00613015|O2|Outcome|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
450465|NCT00613015|O1|Outcome|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
450466|NCT00613015|E6|Reported Event|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
450467|NCT00613015|E5|Reported Event|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
450468|NCT00613015|E4|Reported Event|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
450469|NCT00613015|E3|Reported Event|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
450470|NCT00613015|E2|Reported Event|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
450471|NCT00613015|E1|Reported Event|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
450472|NCT00613028|B3|Baseline|Total|Total of all reporting groups
450473|NCT00613028|B2|Baseline|Etoposide Arm|Pts treated w Bev + Etoposide
450474|NCT00613028|B1|Baseline|Temozolomide Arm|Pts treated w Bev + Temozolomide
450475|NCT00613028|P2|Participant Flow|Etoposide Arm|Bevacizumab + Etoposide: Patients who progressed or had grade 3 or greater toxicity related to prior daily temozolomide dosing, but have not had prior progression or grade 3 or greater toxicity related to prior daily etoposide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Etoposide will be administered once daily at 50 mg/m^2/day for the first 21 days of each 28-day cycle.
450476|NCT00613028|P1|Participant Flow|Temozolomide Arm|Bevacizumab + Temozolomide: Patients who progressed or had grade 3 or greater toxicity related to prior daily etoposide dosing, but have not had prior progression or grade 3 toxicity related to prior daily temozolomide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Temozolomide will be administered ona continuous daily dosing schedule at 50 mg/m^2/day.
450477|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
450478|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
450479|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
450480|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
450481|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
450482|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
450483|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
450484|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
450485|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
450486|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
450487|NCT00613028|E2|Reported Event|Etoposide Arm|Pts treated w Bev + Etoposide
450488|NCT00613028|E1|Reported Event|Temozolomide Arm|Pts treated w Bev + Temozolomide
450561|NCT00613405|B2|Baseline|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
455434|NCT00614939|O1|Outcome|Placebo|Placebo
450489|NCT00613080|B1|Baseline|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
450490|NCT00613080|P1|Participant Flow|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
450491|NCT00613080|O1|Outcome|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
450492|NCT00613080|E1|Reported Event|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
450493|NCT00613106|B3|Baseline|Total|Total of all reporting groups
450497|NCT00613106|P1|Participant Flow|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
450498|NCT00613106|O2|Outcome|Ibuprofen|Ibuprofen 800mg
450499|NCT00613106|O1|Outcome|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
450500|NCT00613106|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
450501|NCT00613106|E1|Reported Event|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
450502|NCT00613301|B1|Baseline|Pramipexole|The number of patients enrolled was 416. The number of case report form which were collected was 364. Moreover the number of patients analyzed as safety analysis was 346 because 18 patients were excluded due to protocol violations.
450503|NCT00613301|P1|Participant Flow|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
450504|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
450505|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
450506|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
450507|NCT00613301|O1|Outcome|Pramipexole|Substance (INN): Pramipexole Trade name: BI-Sifrol® Pharmaceutical form: Tablet Source: Marketed products (There was no investigational products in this PMS) Unit strength: 0.125 mg and 0.5 mg Daily dose: Approved dose range (From 0.25 mg/day to 4.5 mg/day) Duration of use: 3 years Route of administration: Orally
450508|NCT00613301|E1|Reported Event|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
450509|NCT00613314|B1|Baseline|Telmisartan (Micardis)|
450510|NCT00613314|P1|Participant Flow|Telmisartan (Micardis)|
450511|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
450512|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
450513|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
450514|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
450515|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
450516|NCT00613314|E1|Reported Event|Telmisartan (Micardis)|
450517|NCT00613327|B1|Baseline|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450518|NCT00613327|P1|Participant Flow|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450519|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450520|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450521|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450522|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450523|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450588|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450524|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450525|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450526|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450527|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
451338|NCT00617084|O1|Outcome|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
450528|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450529|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450530|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450531|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450532|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450533|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450534|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450535|NCT00613327|E1|Reported Event|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
450536|NCT00613366|B3|Baseline|Total|Total of all reporting groups
450537|NCT00613366|B2|Baseline|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
450538|NCT00613366|B1|Baseline|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
450539|NCT00613366|P2|Participant Flow|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
450540|NCT00613366|P1|Participant Flow|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
450541|NCT00613366|O2|Outcome|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
450542|NCT00613366|O1|Outcome|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
450543|NCT00613366|O2|Outcome|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
450544|NCT00613366|O1|Outcome|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
450545|NCT00613366|E2|Reported Event|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
450546|NCT00613366|E1|Reported Event|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
450547|NCT00613379|B4|Baseline|Total|Total of all reporting groups
450548|NCT00613379|B3|Baseline|Arm 3|PBO, one IV dose (N=10)
450549|NCT00613379|B2|Baseline|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
450550|NCT00613379|B1|Baseline|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
450551|NCT00613379|P3|Participant Flow|Arm 3|PBO, one IV dose (N=10)
450552|NCT00613379|P2|Participant Flow|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
450553|NCT00613379|P1|Participant Flow|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
450554|NCT00613379|O3|Outcome|Arm 3|PBO, one IV dose (N=10)
450555|NCT00613379|O2|Outcome|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
450556|NCT00613379|O1|Outcome|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
450557|NCT00613379|E3|Reported Event|Arm 3|PBO, one IV dose (N=10)
450558|NCT00613379|E2|Reported Event|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
450559|NCT00613379|E1|Reported Event|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
450560|NCT00613405|B3|Baseline|Total|Total of all reporting groups
450562|NCT00613405|B1|Baseline|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
450563|NCT00613405|P2|Participant Flow|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
450564|NCT00613405|P1|Participant Flow|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
450565|NCT00613405|O2|Outcome|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
450566|NCT00613405|O1|Outcome|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
450798|NCT00613938|P4|Participant Flow|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
450567|NCT00613405|E2|Reported Event|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
450568|NCT00613405|E1|Reported Event|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
450569|NCT00613509|B3|Baseline|Total|Total of all reporting groups
450570|NCT00613509|B2|Baseline|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450571|NCT00613509|B1|Baseline|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
450572|NCT00613509|P2|Participant Flow|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450573|NCT00613509|P1|Participant Flow|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
450574|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450575|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
450576|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450577|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
450578|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450579|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
450580|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450581|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
450582|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450583|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
450584|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450585|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
450586|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450587|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
453512|NCT00619151|E1|Reported Event|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
450589|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
450590|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450591|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
450592|NCT00613509|E2|Reported Event|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
450655|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
451339|NCT00617084|O2|Outcome|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
450593|NCT00613509|E1|Reported Event|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
450594|NCT00613574|B1|Baseline|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
450595|NCT00613574|P1|Participant Flow|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
450596|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
450597|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
450598|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
450599|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
450600|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
450601|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
450602|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
450603|NCT00613574|E1|Reported Event|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
450604|NCT00613626|B4|Baseline|Total|Total of all reporting groups
450605|NCT00613626|B3|Baseline|Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
450606|NCT00613626|B2|Baseline|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
450607|NCT00613626|B1|Baseline|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily"
450608|NCT00613626|P3|Participant Flow|Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
450609|NCT00613626|P2|Participant Flow|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
450610|NCT00613626|P1|Participant Flow|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily"
450647|NCT00604175|P2|Participant Flow|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450648|NCT00604175|P1|Participant Flow|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450611|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
450612|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily"
450613|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
450614|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily"
450615|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
450616|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily"
450617|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
450618|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily"
450619|NCT00613626|O2|Outcome|Arm B: ZD6474 + Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
450620|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily"
450621|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
450622|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily"
450623|NCT00613626|E2|Reported Event|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
450783|NCT00613925|B2|Baseline|Explora Group|Women were randomized to the Explora device for endometrial biopsy
450624|NCT00613626|E1|Reported Event|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily"
450625|NCT00613730|B1|Baseline|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
450626|NCT00613730|P1|Participant Flow|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
450627|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
450628|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
450629|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
450630|NCT00613730|E1|Reported Event|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
450631|NCT00604162|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison."
450632|NCT00604162|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison."
450633|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
450634|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
450635|NCT00604162|O1|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
450636|NCT00604162|O2|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
450637|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
450638|NCT00604162|O2|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
450639|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
450640|NCT00604162|E2|Reported Event|Adverse Events Related to the Capsule|AE related to the capsule endoscopy procedure
450641|NCT00604162|E1|Reported Event|Adverse Events Related to Colonoscopy|AE related to colonoscopy procedure
450642|NCT00604175|B4|Baseline|Total|Total of all reporting groups
450643|NCT00604175|B3|Baseline|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450644|NCT00604175|B2|Baseline|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450645|NCT00604175|B1|Baseline|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450646|NCT00604175|P3|Participant Flow|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450784|NCT00613925|B1|Baseline|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
450649|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450650|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450651|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450652|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450653|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450654|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450656|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450657|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450658|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450659|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450660|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450661|NCT00604175|O3|Outcome|Stratum C/Baseline HPV18+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV18 at baseline.
450662|NCT00604175|O2|Outcome|Stratum B/Baseline HPV18+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV18 at baseline.
450663|NCT00604175|O1|Outcome|Stratum A/Baseline HPV18+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV18 at baseline.
450664|NCT00604175|O3|Outcome|Stratum C/Baseline HPV16+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV16 at baseline.
450665|NCT00604175|O2|Outcome|Stratum B/Baseline HPV16+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV16 at baseline.
450666|NCT00604175|O1|Outcome|Stratum A/Baseline HPV16+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV16 at baseline.
450667|NCT00604175|O3|Outcome|Stratum C/Baseline HPV11+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV11 at baseline.
450668|NCT00604175|O2|Outcome|Stratum B/Baseline HPV11+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV11 at baseline.
450669|NCT00604175|O1|Outcome|Stratum A/Baseline HPV11+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV11 at baseline.
450670|NCT00604175|O3|Outcome|Stratum C/Baseline HPV6+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV6 at baseline.
450671|NCT00604175|O2|Outcome|Stratum B/Baseline HPV6+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV6 at baseline.
450672|NCT00604175|O1|Outcome|Stratum A/Baseline HPV6+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV6 at baseline.
450673|NCT00604175|O3|Outcome|Stratum C/Baseline HPV18-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV18 at baseline.
450674|NCT00604175|O2|Outcome|Stratum B/Baseline HPV18-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV18 at baseline.
450675|NCT00604175|O1|Outcome|Stratum A/Baseline HPV18-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV18 at baseline.
450676|NCT00604175|O3|Outcome|Stratum C/Baseline HPV16-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV16 at baseline.
450677|NCT00604175|O2|Outcome|Stratum B/Baseline HPV16-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV16 at baseline.
450678|NCT00604175|O1|Outcome|Stratum A/Baseline HPV16-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV16 at baseline.
450679|NCT00604175|O3|Outcome|Stratum C/Baseline HPV11-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV11 at baseline.
450680|NCT00604175|O2|Outcome|Stratum B/Baseline HPV11-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV11 at baseline.
450681|NCT00604175|O1|Outcome|Stratum A/Baseline HPV11-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV11 at baseline.
450682|NCT00604175|O3|Outcome|Stratum C/Baseline HPV6-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV6 at baseline.
450683|NCT00604175|O2|Outcome|Stratum B/Baseline HPV6-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV6 at baseline.
450684|NCT00604175|O1|Outcome|Stratum A/Baseline HPV6-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV6 at baseline.
450685|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450686|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450687|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450688|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450689|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450690|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450691|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450692|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450693|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450694|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450695|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450696|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450697|NCT00604175|E3|Reported Event|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450698|NCT00604175|E2|Reported Event|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450699|NCT00604175|E1|Reported Event|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
450700|NCT00604188|B3|Baseline|Total|Total of all reporting groups
450701|NCT00604188|B2|Baseline|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450702|NCT00604188|B1|Baseline|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450703|NCT00604188|P2|Participant Flow|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450704|NCT00604188|P1|Participant Flow|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450705|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450706|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450707|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450708|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450709|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450710|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450711|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450712|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450713|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450714|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450715|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450716|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
453717|NCT00619957|E2|Reported Event|Risedronate Year 2|Risedronate 35 mg tablet once weekly Years 1 & 2
450717|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450718|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450719|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450720|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450721|NCT00604188|E2|Reported Event|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450722|NCT00604188|E1|Reported Event|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
450723|NCT00604214|B3|Baseline|Total|Total of all reporting groups
450724|NCT00604214|B2|Baseline|Placebo|0.9% sodium chloride, intravenous, 96 hours
450725|NCT00604214|B1|Baseline|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450726|NCT00604214|P2|Participant Flow|Placebo|0.9% sodium chloride, intravenous, 96 hours
450727|NCT00604214|P1|Participant Flow|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450728|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450729|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450730|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450731|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450732|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450733|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450734|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450735|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450736|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450737|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450738|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450739|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450740|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450741|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450742|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450743|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450744|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450745|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450746|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450747|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450748|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450749|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450750|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450751|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450752|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
450753|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450754|NCT00604214|E2|Reported Event|Placebo|0.9% sodium chloride, intravenous, 96 hours
450755|NCT00604214|E1|Reported Event|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
450756|NCT00604279|B3|Baseline|Total|Total of all reporting groups
450757|NCT00604279|B2|Baseline|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
450758|NCT00604279|B1|Baseline|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
450759|NCT00604279|P2|Participant Flow|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
450760|NCT00604279|P1|Participant Flow|Paliperidone Palmitate|Paliperidone palmitate (R092670) suspension for intramuscular (directly into a muscle) injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
450761|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
450762|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
450763|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
450764|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
450765|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
450766|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
450767|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
450768|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
450769|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
450770|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
450771|NCT00604279|E2|Reported Event|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
450772|NCT00604279|E1|Reported Event|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
450773|NCT00613821|B3|Baseline|Total|Total of all reporting groups
450774|NCT00613821|B2|Baseline|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
450775|NCT00613821|B1|Baseline|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
450776|NCT00613821|P2|Participant Flow|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
450777|NCT00613821|P1|Participant Flow|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
450778|NCT00613821|O2|Outcome|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
450779|NCT00613821|O1|Outcome|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
450780|NCT00613821|E2|Reported Event|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
450781|NCT00613821|E1|Reported Event|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
450782|NCT00613925|B3|Baseline|Total|Total of all reporting groups
450787|NCT00613925|O2|Outcome|Explora Group|Women were randomized to the Explora device for endometrial biopsy
450788|NCT00613925|O1|Outcome|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
450789|NCT00613925|O2|Outcome|Explora Group|Women were randomized to the Explora device for endometrial biopsy
450790|NCT00613925|O1|Outcome|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
450791|NCT00613925|E2|Reported Event|Explora Group|Women were randomized to the Explora device for endometrial biopsy
450792|NCT00613925|E1|Reported Event|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
450793|NCT00613938|B5|Baseline|Total|Total of all reporting groups
450794|NCT00613938|B4|Baseline|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
450795|NCT00613938|B3|Baseline|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
450796|NCT00613938|B2|Baseline|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
450799|NCT00613938|P3|Participant Flow|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
450800|NCT00613938|P2|Participant Flow|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
450801|NCT00613938|P1|Participant Flow|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
450802|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
450803|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
450804|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
450805|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
450806|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
450807|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
450808|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
450809|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
450810|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
450811|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
450812|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
450813|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
450814|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
450815|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
450816|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
450817|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
450818|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
450819|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
450820|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
450821|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
450822|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
450823|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
450824|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
450825|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
450826|NCT00613938|E4|Reported Event|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
450827|NCT00613938|E3|Reported Event|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
450828|NCT00613938|E2|Reported Event|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
450829|NCT00613938|E1|Reported Event|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
450830|NCT00613951|B4|Baseline|Total|Total of all reporting groups
450831|NCT00613951|B3|Baseline|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450832|NCT00613951|B2|Baseline|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450833|NCT00613951|B1|Baseline|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450834|NCT00613951|P3|Participant Flow|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450968|NCT00614120|E2|Reported Event|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450835|NCT00613951|P2|Participant Flow|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450836|NCT00613951|P1|Participant Flow|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450837|NCT00613951|O3|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450858|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450838|NCT00613951|O2|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450839|NCT00613951|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450840|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450841|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450842|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450843|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450844|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450845|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450846|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450847|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450848|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450849|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450850|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450851|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450852|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450853|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450854|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450969|NCT00614120|E1|Reported Event|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450855|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450856|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450857|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
451017|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
450859|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450860|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450861|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450862|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450863|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450864|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450865|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450866|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450867|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450868|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450869|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450870|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450871|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450872|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450873|NCT00613951|E3|Reported Event|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450874|NCT00613951|E2|Reported Event|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450919|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450970|NCT00616421|B4|Baseline|Total|Total of all reporting groups
450875|NCT00613951|E1|Reported Event|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450876|NCT00614055|B4|Baseline|Total|Total of all reporting groups
450877|NCT00614055|B3|Baseline|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450878|NCT00614055|B2|Baseline|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
451018|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
450879|NCT00614055|B1|Baseline|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450880|NCT00614055|P3|Participant Flow|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450881|NCT00614055|P2|Participant Flow|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450882|NCT00614055|P1|Participant Flow|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450883|NCT00614055|O3|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450884|NCT00614055|O2|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450885|NCT00614055|O1|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450886|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450887|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450888|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450889|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450890|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450891|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450892|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450893|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450894|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450895|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450896|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450966|NCT00614120|E4|Reported Event|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
450967|NCT00614120|E3|Reported Event|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450897|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450898|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450899|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
451019|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
450900|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450901|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450902|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450903|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450904|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450905|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450906|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450907|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450908|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450909|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450910|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450911|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450912|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450913|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450914|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450915|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450916|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450917|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450918|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
455435|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
450920|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450921|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450922|NCT00614055|E3|Reported Event|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450923|NCT00614055|E2|Reported Event|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450924|NCT00614055|E1|Reported Event|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
450925|NCT00614120|B5|Baseline|Total|Total of all reporting groups
450926|NCT00614120|B4|Baseline|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
450927|NCT00614120|B3|Baseline|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450928|NCT00614120|B2|Baseline|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450929|NCT00614120|B1|Baseline|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450930|NCT00614120|P4|Participant Flow|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
450931|NCT00614120|P3|Participant Flow|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450932|NCT00614120|P2|Participant Flow|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450933|NCT00614120|P1|Participant Flow|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450934|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
450935|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450936|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450937|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450938|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
450939|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450940|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450941|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450942|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
450943|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450944|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450945|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450946|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
450947|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450948|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450949|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450950|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
450951|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450952|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450953|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450954|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
450955|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450956|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450957|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450958|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
450959|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450960|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450961|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450962|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
450963|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450964|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450965|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
450971|NCT00616421|B3|Baseline|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1.
450972|NCT00616421|B2|Baseline|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day1.
450973|NCT00616421|B1|Baseline|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age.
450974|NCT00616421|P3|Participant Flow|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
450975|NCT00616421|P2|Participant Flow|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day 1
450976|NCT00616421|P1|Participant Flow|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study days 1 and 61 in children 2 to 5 years of age
450977|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
450978|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
450979|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|The licensed meningococcal MenACWY polysaccharide vaccine was administered by IM in children 6 to 10 years of age.
450980|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|The Novartis MenACWY-CRM vaccine was administered by IM in children 6 to 10 years of age.
450981|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|The licensed meningococcal MenACWY polysaccharide vaccine was administered by IM in children 2 to 5 years of age.
450982|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|The Novartis MenACWY-CRM vaccine was administered by IM in children 2 to 5 years of age.
450983|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
450984|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
450985|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
450986|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
450987|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
450988|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
450989|NCT00616421|O4|Outcome|Licensed Polysaccharide Vaccine (6 to 10 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 6 to 10 years of age
450990|NCT00616421|O3|Outcome|MenACWY-CRM (6 to 10 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
450991|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (2 to 5 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 2 to 5 years of age
450992|NCT00616421|O1|Outcome|MenACWY-CRM (2 to 5 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age.
450993|NCT00616421|O4|Outcome|Licensed Polysaccharide Vaccine (6 to 10 Yoa)|1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
450994|NCT00616421|O3|Outcome|MenACWY-CRM (6 to 10 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
450995|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (2 to 5 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 2 to 5 years of age.
450996|NCT00616421|O1|Outcome|MenACWY-CRM (2 to 5 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age.
450997|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
450998|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
450999|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
451000|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
451001|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
451002|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
451003|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
451004|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
451005|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
451006|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
451007|NCT00616421|E5|Reported Event|Licensed Polysaccharide Vaccine_6 to 10 Years|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age.
451008|NCT00616421|E4|Reported Event|Licensed Polysaccharide Vaccine_2 to 5 Years|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age.
451009|NCT00616421|E3|Reported Event|MenACWY-CRM (1 Dose)_6 to 10 Years|1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age.
451010|NCT00616421|E2|Reported Event|MenACWY-CRM (1 Dose)_2 to 5 Years|1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age.
451011|NCT00616421|E1|Reported Event|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
451012|NCT00616434|B3|Baseline|Total|Total of all reporting groups
451013|NCT00616434|B2|Baseline|Placebo|Placebo IM injection twice weekly for 12 weeks
451014|NCT00616434|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
451015|NCT00616434|P2|Participant Flow|Placebo|Placebo IM injection twice weekly for 12 weeks
451016|NCT00616434|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
451020|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
451021|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
451022|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
451023|NCT00616434|E2|Reported Event|Placebo|Placebo IM injection twice weekly for 12 weeks
451024|NCT00616434|E1|Reported Event|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
451025|NCT00616577|B4|Baseline|Total|Total of all reporting groups
451026|NCT00616577|B3|Baseline|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.
Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
451027|NCT00616577|B2|Baseline|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.
Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
451028|NCT00616577|B1|Baseline|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.
Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
451029|NCT00616577|P3|Participant Flow|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.
Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
451030|NCT00616577|P2|Participant Flow|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.
Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
451031|NCT00616577|P1|Participant Flow|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.
Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
451032|NCT00616577|O3|Outcome|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.
Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
451033|NCT00616577|O2|Outcome|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.
Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
451034|NCT00616577|O1|Outcome|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.
Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
451035|NCT00616577|E3|Reported Event|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.
Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
451036|NCT00616577|E2|Reported Event|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.
Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
451037|NCT00616577|E1|Reported Event|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.
Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
451038|NCT00616603|B4|Baseline|Total|Total of all reporting groups
451039|NCT00616603|B3|Baseline|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
451040|NCT00616603|B2|Baseline|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
451041|NCT00616603|B1|Baseline|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
451042|NCT00616603|P3|Participant Flow|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
451043|NCT00616603|P2|Participant Flow|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
451094|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
451044|NCT00616603|P1|Participant Flow|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
451045|NCT00616603|O3|Outcome|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
451046|NCT00616603|O2|Outcome|Group B|Subjects in Group B will have 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml of normal saline
451047|NCT00616603|O1|Outcome|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal sali
451048|NCT00616603|E3|Reported Event|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
451049|NCT00616603|E2|Reported Event|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
451050|NCT00616603|E1|Reported Event|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
451051|NCT00616629|B6|Baseline|Total|Total of all reporting groups
451053|NCT00616629|B4|Baseline|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
451054|NCT00616629|B3|Baseline|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
451055|NCT00616629|B2|Baseline|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
451056|NCT00616629|B1|Baseline|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
451057|NCT00616629|P5|Participant Flow|Placebo|Corresponding placebo
451058|NCT00616629|P4|Participant Flow|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
451059|NCT00616629|P3|Participant Flow|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
451060|NCT00616629|P2|Participant Flow|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
451061|NCT00616629|P1|Participant Flow|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
451062|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
451063|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
451064|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
451065|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
451066|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
451067|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
451068|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
451069|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
451070|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
451071|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
451072|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
451073|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
451074|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
451075|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
451076|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
451077|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
451078|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
451079|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
451080|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
451081|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
451082|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
451083|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
451084|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
451085|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
451086|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
451087|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
451088|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
451089|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
451090|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
451091|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
451092|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
451093|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
451145|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451095|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
451096|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
451097|NCT00616629|E5|Reported Event|Placebo|Corresponding placebo
451098|NCT00616629|E4|Reported Event|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
451099|NCT00616629|E3|Reported Event|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
451100|NCT00616629|E2|Reported Event|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
451101|NCT00616629|E1|Reported Event|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
451102|NCT00616642|B3|Baseline|Total|Total of all reporting groups
451158|NCT00616759|P1|Participant Flow|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
451159|NCT00616759|O2|Outcome|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
451103|NCT00616642|B2|Baseline|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally"
451104|NCT00616642|B1|Baseline|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally"
451105|NCT00616642|P2|Participant Flow|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally"
451106|NCT00616642|P1|Participant Flow|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally"
451107|NCT00616642|O2|Outcome|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally"
451108|NCT00616642|O1|Outcome|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally"
451109|NCT00616642|E2|Reported Event|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally"
451110|NCT00616642|E1|Reported Event|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally"
451111|NCT00616655|B4|Baseline|Total|Total of all reporting groups
451112|NCT00616655|B3|Baseline|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451113|NCT00616655|B2|Baseline|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451114|NCT00616655|B1|Baseline|Placebo Arm|Placebo
451115|NCT00616655|P3|Participant Flow|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451116|NCT00616655|P2|Participant Flow|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451117|NCT00616655|P1|Participant Flow|Placebo Arm|Placebo
451118|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451119|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451120|NCT00616655|O1|Outcome|Placebo Arm|Placebo
451121|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451122|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451123|NCT00616655|O1|Outcome|Placebo Arm|Placebo
451124|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451125|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451126|NCT00616655|O1|Outcome|Placebo Arm|Placebo
451127|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451128|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451129|NCT00616655|O1|Outcome|Placebo Arm|Placebo
451130|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451131|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451132|NCT00616655|O1|Outcome|Placebo Arm|Placebo
451133|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451134|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451135|NCT00616655|O1|Outcome|Placebo Arm|Placebo
451136|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451137|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451138|NCT00616655|O1|Outcome|Placebo Arm|Placebo
451139|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451140|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451141|NCT00616655|O1|Outcome|Placebo Arm|Placebo
451142|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451143|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451144|NCT00616655|O1|Outcome|Placebo Arm|Placebo
455436|NCT00614939|O1|Outcome|Placebo|Placebo
451148|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451149|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451150|NCT00616655|O1|Outcome|Placebo Arm|Placebo
451151|NCT00616655|E3|Reported Event|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
451152|NCT00616655|E2|Reported Event|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
451153|NCT00616655|E1|Reported Event|Placebo Arm|Placebo
451154|NCT00616759|B3|Baseline|Total|Total of all reporting groups
451155|NCT00616759|B2|Baseline|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
451156|NCT00616759|B1|Baseline|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
451157|NCT00616759|P2|Participant Flow|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
451160|NCT00616759|O1|Outcome|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
451161|NCT00616759|E2|Reported Event|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
451162|NCT00616759|E1|Reported Event|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
451163|NCT00616772|B3|Baseline|Total|Total of all reporting groups
451164|NCT00616772|B2|Baseline|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
451165|NCT00616772|B1|Baseline|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
451166|NCT00616772|P2|Participant Flow|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
451167|NCT00616772|P1|Participant Flow|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
451168|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
451169|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
451170|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
451171|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
451172|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
451173|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
451174|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
451175|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
451176|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
451177|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
451178|NCT00616772|E2|Reported Event|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
451179|NCT00616772|E1|Reported Event|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
451180|NCT00616902|B3|Baseline|Total|Total of all reporting groups
451181|NCT00616902|B2|Baseline|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451182|NCT00616902|B1|Baseline|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451183|NCT00616902|P2|Participant Flow|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451184|NCT00616902|P1|Participant Flow|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451185|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451186|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451187|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451188|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451189|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451190|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451191|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451192|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451193|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451194|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451195|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451196|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451197|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451198|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451199|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451200|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451201|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451202|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451203|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451204|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451205|NCT00616902|E2|Reported Event|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451206|NCT00616902|E1|Reported Event|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
451207|NCT00616928|B5|Baseline|Total|Total of all reporting groups
451208|NCT00616928|B4|Baseline|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451340|NCT00617084|O1|Outcome|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
451209|NCT00616928|B3|Baseline|Influenza A (H5N1) >64Y Group|Influenza A (H5N1) >64Y Group Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451210|NCT00616928|B2|Baseline|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451211|NCT00616928|B1|Baseline|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451212|NCT00616928|P4|Participant Flow|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451213|NCT00616928|P3|Participant Flow|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451214|NCT00616928|P2|Participant Flow|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451215|NCT00616928|P1|Participant Flow|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451216|NCT00616928|O2|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451217|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451218|NCT00616928|O2|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451219|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451220|NCT00616928|O4|Outcome|Placebo ˃ 64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451221|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451222|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451223|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451224|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged >64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451246|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451225|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451226|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451227|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451228|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451229|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451230|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451231|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451232|NCT00616928|O4|Outcome|Placebo ˃ 64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451233|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451234|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451235|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451236|NCT00616928|O4|Outcome|Placebo >60Y Group|Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451237|NCT00616928|O3|Outcome|Influenza A (H5N1) >60Y Group|Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451238|NCT00616928|O2|Outcome|Placebo 18-60Y Group|Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451239|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-60Y Group|Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451240|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451241|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451242|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451243|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451244|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451245|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451375|NCT00617175|B3|Baseline|Total|Total of all reporting groups
455437|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
451247|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451248|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451249|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451250|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451251|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451252|NCT00616928|O6|Outcome|Placebo Group|Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451253|NCT00616928|O5|Outcome|Influenza A (H5N1) Group|Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451254|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451255|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451256|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451257|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451258|NCT00616928|O6|Outcome|Placebo Group|Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451259|NCT00616928|O5|Outcome|Influenza A (H5N1) Group|Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451260|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451261|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451262|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451263|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm
451264|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451265|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451266|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451267|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm
451376|NCT00617175|B2|Baseline|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
451268|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451269|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451270|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451271|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451272|NCT00616928|E4|Reported Event|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451273|NCT00616928|E3|Reported Event|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451274|NCT00616928|E2|Reported Event|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451275|NCT00616928|E1|Reported Event|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
451276|NCT00616967|B3|Baseline|Total|Total of all reporting groups
451277|NCT00616967|B2|Baseline|Vorinostat (Arm 2)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
vorinostat: Given orally"
451278|NCT00616967|B1|Baseline|Placebo (Arm 1)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
placebo: Given orally"
451279|NCT00616967|P3|Participant Flow|Vorinostat (Arm II)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
vorinostat: Given orally"
451280|NCT00616967|P2|Participant Flow|Placebo (Arm I)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
placebo: Given orally"
451281|NCT00616967|P1|Participant Flow|Run-in Phase (Arm 0)|"Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).
Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
vorinostat: Given orally"
451282|NCT00616967|O2|Outcome|Non-Responders|Pooled data from participants who did not receive a pathologic complete response across arms.
451283|NCT00616967|O1|Outcome|Responders|Pooled data from participants who received a pathologic complete response across arms.
451284|NCT00616967|O2|Outcome|Arm II|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
vorinostat: Given orally"
451285|NCT00616967|O1|Outcome|Arm I|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
placebo: Given orally"
451286|NCT00616967|E3|Reported Event|Arm II|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
vorinostat: Given orally"
451287|NCT00616967|E2|Reported Event|Arm I|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
placebo: Given orally"
451288|NCT00616967|E1|Reported Event|Run-in Phase (Arm 0)|"Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).
Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
vorinostat: Given orally
Events summarized in this arm are those that met 5% reporting threshold in Arms I and II."
451289|NCT00617058|B4|Baseline|Total|Total of all reporting groups
451290|NCT00617058|B3|Baseline|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451291|NCT00617058|B2|Baseline|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451292|NCT00617058|B1|Baseline|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451313|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451293|NCT00617058|P3|Participant Flow|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451294|NCT00617058|P2|Participant Flow|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451295|NCT00617058|P1|Participant Flow|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451296|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451297|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451298|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451299|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451300|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451301|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451302|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451303|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451304|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451305|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451306|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451307|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451308|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451309|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451377|NCT00617175|B1|Baseline|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
451310|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451311|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451312|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451314|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451315|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451316|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451317|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451318|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451319|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451320|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451321|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451322|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451323|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451324|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451325|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451326|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451327|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451328|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451329|NCT00617058|E3|Reported Event|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
451378|NCT00617175|P2|Participant Flow|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
451379|NCT00617175|P1|Participant Flow|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
451330|NCT00617058|E2|Reported Event|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
451331|NCT00617058|E1|Reported Event|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
451332|NCT00617084|B3|Baseline|Total|Total of all reporting groups
451333|NCT00617084|B2|Baseline|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
451334|NCT00617084|B1|Baseline|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
451335|NCT00617084|P2|Participant Flow|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
451336|NCT00617084|P1|Participant Flow|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
451337|NCT00617084|O2|Outcome|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
451341|NCT00617084|E2|Reported Event|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
451342|NCT00617084|E1|Reported Event|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
451343|NCT00617097|B3|Baseline|Total|Total of all reporting groups
451344|NCT00617097|B2|Baseline|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control with paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
451345|NCT00617097|B1|Baseline|Paracervical Block With Lidocaine|Subjects who received pain control with paracervical block with 18mL of 1% lidocaine and 2mL of saline during first trimester surgical abortion
451346|NCT00617097|P2|Participant Flow|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control of paracervical block with combined 30mg of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
451347|NCT00617097|P1|Participant Flow|Paracervical Block With Lidocaine|Subjects who received paracervical block with 18 mL of 1% lidocaine and 2 mL of saline for pain control during first trimester surgical abortion
451348|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
451349|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
451350|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
451351|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
451352|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
451353|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
451354|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control using paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
451355|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who received pain control using paracervical block with 18mL of 1% lidocaine and 2 mL of saline during first trimester surgical abortion
451356|NCT00617097|E2|Reported Event|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
451357|NCT00617097|E1|Reported Event|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
451358|NCT00617123|B3|Baseline|Total|Total of all reporting groups
451359|NCT00617123|B2|Baseline|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
451360|NCT00617123|B1|Baseline|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
451361|NCT00617123|P2|Participant Flow|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
451362|NCT00617123|P1|Participant Flow|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
451363|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
451364|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
451365|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
451366|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
451367|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
451368|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
451369|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
451370|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
451371|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
451372|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
451373|NCT00617123|E2|Reported Event|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
451374|NCT00617123|E1|Reported Event|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
451382|NCT00617175|E2|Reported Event|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
451383|NCT00617175|E1|Reported Event|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
451384|NCT00617188|B1|Baseline|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
451385|NCT00617188|P1|Participant Flow|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
451386|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
451387|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
451388|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
451389|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
451390|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
451391|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
451392|NCT00617188|E1|Reported Event|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
451393|NCT00617201|B3|Baseline|Total|Total of all reporting groups
451394|NCT00617201|B2|Baseline|Atomoxetine|Atomoxetine (80 mg/day)
451395|NCT00617201|B1|Baseline|Placebo|Matched placebo
451396|NCT00617201|P2|Participant Flow|Matched Placebo|"Matched Placebo
placebo : Once daily oral dosing - matched placebo"
451397|NCT00617201|P1|Participant Flow|Atomoxetine (80 mg/Day)|"Active drug
atomoxetine : Once daily oral dosing"
451398|NCT00617201|O2|Outcome|Atomoxetine|Atomoxetine (80 mg/day)
451399|NCT00617201|O1|Outcome|Placebo|Matched placebo
451400|NCT00617201|O2|Outcome|Atomoxetine|80 mg/day (after intial 4-day run up)
451401|NCT00617201|O1|Outcome|Placebo|Matched Placebo
451402|NCT00617201|E2|Reported Event|Matched Placebo|"Matched Placebo
placebo : Once daily oral dosing - matched placebo"
451403|NCT00617201|E1|Reported Event|Atomoxetine (80 mg/Day)|"Active drug
atomoxetine : Once daily oral dosing"
451404|NCT00617240|B3|Baseline|Total|Total of all reporting groups
451405|NCT00617240|B2|Baseline|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
451406|NCT00617240|B1|Baseline|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
451407|NCT00617240|P2|Participant Flow|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
451408|NCT00617240|P1|Participant Flow|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
451409|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
451410|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
451411|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
451412|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
451413|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
451414|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
451415|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
451416|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
451417|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
451418|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
451419|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
451420|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
451421|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
451422|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
451423|NCT00617240|E2|Reported Event|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
451424|NCT00617240|E1|Reported Event|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
451425|NCT00617279|B3|Baseline|Total|Total of all reporting groups
451426|NCT00617279|B2|Baseline|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451427|NCT00617279|B1|Baseline|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451443|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451562|NCT00617409|O3|Outcome|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
455438|NCT00614939|O1|Outcome|Placebo|Placebo
451428|NCT00617279|P2|Participant Flow|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451429|NCT00617279|P1|Participant Flow|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451461|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451504|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
451430|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451431|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451432|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451433|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451434|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451435|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451436|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451437|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451438|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451439|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451440|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451441|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451442|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451444|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451445|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451446|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451447|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451448|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451449|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451450|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451451|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451452|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451453|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451454|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451455|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451456|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451457|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451458|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451459|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451460|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451462|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451463|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451464|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451465|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451466|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451467|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451468|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451469|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451470|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451471|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451472|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451473|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451499|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
451563|NCT00617409|O2|Outcome|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
451474|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451475|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451503|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
451476|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451477|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451478|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
451479|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
451480|NCT00617279|E2|Reported Event|Disadvantaged Autologous Vein Graft|Disadvantaged Autologous Vein Graft
451481|NCT00617279|E1|Reported Event|GORE PROPATEN Vascular Graft|GORE PROPATEN Vascular Graft
451482|NCT00617305|B4|Baseline|Total|Total of all reporting groups
451483|NCT00617305|B3|Baseline|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
451484|NCT00617305|B2|Baseline|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i
451485|NCT00617305|B1|Baseline|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
451486|NCT00617305|P3|Participant Flow|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
451487|NCT00617305|P2|Participant Flow|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i
451488|NCT00617305|P1|Participant Flow|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
451489|NCT00617305|O2|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
451490|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
451491|NCT00617305|O2|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
451492|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
451493|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
451494|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
451495|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
451496|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
451497|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
451498|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
451564|NCT00617409|O1|Outcome|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
451500|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
451501|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
451502|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
451619|NCT00617461|E6|Reported Event|Overall GEn|All participants receiving GEn in any treatment period
451505|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
451506|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
451507|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
451508|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
451509|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
451510|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
451511|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
451512|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
451513|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
451514|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
451515|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
451516|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
451517|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
451518|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
451519|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
451520|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
451521|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
451522|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
451523|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
451524|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
451525|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
451526|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
451561|NCT00617409|P1|Participant Flow|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
451527|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
451528|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
451529|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
451530|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
451531|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
451532|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
451533|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
451534|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
451535|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
451536|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
451537|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
451538|NCT00617305|E3|Reported Event|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
451539|NCT00617305|E2|Reported Event|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i
451540|NCT00617305|E1|Reported Event|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
451541|NCT00617357|B1|Baseline|One Arm|Strattice Reconstructive Tissue Matrix
451542|NCT00617357|P1|Participant Flow|Strattice Tissue Matrix|
451543|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.
LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
451544|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.
LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
451545|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.
LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
451546|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.
LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
451547|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.
LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
451548|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.
LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
451549|NCT00617357|O1|Outcome|One Arm|Strattice Reconstructive Tissue Matrix
451550|NCT00617357|E1|Reported Event|Strattice|
451551|NCT00617396|B1|Baseline|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subjects begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total) 25 subjects were enrolled in this group.
451552|NCT00617396|P1|Participant Flow|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subjects begin with a dose quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. 25 subjects were enrolled in this group.
451553|NCT00617396|O1|Outcome|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)30 subjects were enrolled in this group.
451554|NCT00617396|E1|Reported Event|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subject begin with a dose Quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)29 subjects were enrolled in this group.
451555|NCT00617409|B4|Baseline|Total|Total of all reporting groups
451556|NCT00617409|B3|Baseline|Arm C - Experimental|Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
451557|NCT00617409|B2|Baseline|Arm B - Experimental|Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
451558|NCT00617409|B1|Baseline|Arm A - Active Comparator|Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
451559|NCT00617409|P3|Participant Flow|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
451560|NCT00617409|P2|Participant Flow|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
451565|NCT00617409|O3|Outcome|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
451566|NCT00617409|O2|Outcome|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
451567|NCT00617409|O1|Outcome|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
451568|NCT00617409|E3|Reported Event|Arm C - Experimental|Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
451569|NCT00617409|E2|Reported Event|Arm B - Experimental|Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
451570|NCT00617409|E1|Reported Event|Arm A - Active Comparator|Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
451571|NCT00617461|B1|Baseline|All Participants in the Intent-to-Treat Population|All randomized participants who took at least one dose of study drug and had at least one post-baseline efficacy assessment, summarized independent of treatment sequence.
451682|NCT00617669|B1|Baseline|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
452551|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
451572|NCT00617461|P2|Participant Flow|GEn 3600 mg/Day Followed by GEn 1200 mg/Day|GEn 3600 mg/day administered for 28 days, followed by a 4-day crossover period during which participants received GEn 2400 mg/day. After the crossover period, participants switched to a dose of 1200 mg/day for 28 days. After completion of the second treatment period, participants entered a down-titration period in which they received 2400 mg/day for 2 days, followed by 1200 mg/day for 2 days, followed by 600 mg/day for 2 days.
451573|NCT00617461|P1|Participant Flow|GEn 1200 mg/Day Followed by GEn 3600 mg/Day|Gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, 1200 mg/day administered for 28 days, followed by a 4-day crossover period during which participants received GEn 2400 mg/day. After the crossover period, participants switched to a dose of 3600 mg/day for 28 days. After completion of the second treatment period, participants entered a down-titration period in which they received 1200 mg/day for 3 days, followed by 600 mg/ day for 3 days.
451574|NCT00617461|O3|Outcome|Gabapentin 1800 mg|PK population from Gabapentin 1800 mg Baseline Treatment period
451575|NCT00617461|O2|Outcome|GEn 3600 mg|PK population from GEn 3600 mg treatment daily from either first intervention period or second intervention period
451576|NCT00617461|O1|Outcome|GEn 1200 mg|PK population from GEn 1200 mg treatment daily from either first intervention period or second intervention period
451577|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451578|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451579|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451580|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451581|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily in second intervention period
451582|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
451583|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
451584|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
451585|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451586|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451587|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily either in second intervention period
451588|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
451589|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
451590|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
451591|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451592|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451593|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451594|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451595|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily in second intervention period
451596|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
451597|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
451598|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
451599|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451600|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451601|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451602|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451603|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451604|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451605|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451606|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451607|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451608|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451609|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451610|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451611|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451612|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451613|NCT00617461|O4|Outcome|GEn 3600 mg in Second Interevention Period|GEn 3600 mg daily in second intervention period only
451614|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period only
451615|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period only
451616|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period only
451617|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451618|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451620|NCT00617461|E5|Reported Event|Down-Titration Period|Participants down- titrated from GEn 3600 mg/day by taking 2400 mg/day for 2 days, followed by 1200 mg/day for 2 days, followed by 600 mg/day for 2 days before ending the assigned treatment. Participants down- titrated from GEn 1200 mg/day by taking 1200 mg/day for 3 days, followed by 600 mg/day for 3 days before ending the assigned treatment.
451621|NCT00617461|E4|Reported Event|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
451622|NCT00617461|E3|Reported Event|Crossover GEn 2400 mg|GEn 2400 mg daily during 4-day crossover period in between the first intervention period and the second intervention period
451623|NCT00617461|E2|Reported Event|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
451624|NCT00617461|E1|Reported Event|Baseline Gabapentin 1800 mg|Gabapentin 1800 mg daily for 2 weeks before randomization. Only includes participants who were subsequently randomized.
451625|NCT00617591|B1|Baseline|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
451626|NCT00617591|P1|Participant Flow|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
451627|NCT00617591|O1|Outcome|Induction at Initial Full Dose|"Induction Phase for First 29 Participants
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1."
451628|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
451629|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
451630|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
451631|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
451654|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
455439|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
451632|NCT00617591|E1|Reported Event|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.
Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.
At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.
Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
451633|NCT00617604|B3|Baseline|Total|Total of all reporting groups
451634|NCT00617604|B2|Baseline|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
453570|NCT00619762|O1|Outcome|Treatment Arm|all available patients/breasts who completed specified visit
451635|NCT00617604|B1|Baseline|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451636|NCT00617604|P2|Participant Flow|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451637|NCT00617604|P1|Participant Flow|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451638|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451639|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451640|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451641|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451642|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451643|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451644|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451645|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451646|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451647|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451648|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451649|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451650|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451651|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451652|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451653|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451720|NCT00617708|E3|Reported Event|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
455440|NCT00614939|O1|Outcome|Placebo|Placebo
451655|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451656|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451657|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451683|NCT00617669|P2|Participant Flow|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451658|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451659|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451660|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451661|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451662|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451663|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451664|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451665|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451666|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451667|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451668|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451669|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451670|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451671|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451672|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451673|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451674|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451675|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451676|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451677|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451772|NCT00617851|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza virus vaccine-Strain B
451678|NCT00617604|E2|Reported Event|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
451679|NCT00617604|E1|Reported Event|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
451680|NCT00617669|B3|Baseline|Total|Total of all reporting groups
451681|NCT00617669|B2|Baseline|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451684|NCT00617669|P1|Participant Flow|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451685|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451686|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451687|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451688|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451689|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451690|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451691|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451692|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451693|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451694|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451695|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451696|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451697|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451698|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451699|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451700|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451701|NCT00617669|E2|Reported Event|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451702|NCT00617669|E1|Reported Event|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
451703|NCT00617708|B4|Baseline|Total|Total of all reporting groups
451704|NCT00617708|B3|Baseline|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
451705|NCT00617708|B2|Baseline|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
451706|NCT00617708|B1|Baseline|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
451707|NCT00617708|P3|Participant Flow|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
451708|NCT00617708|P2|Participant Flow|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
451709|NCT00617708|P1|Participant Flow|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
451710|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
451711|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
451712|NCT00617708|O3|Outcome|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
451713|NCT00617708|O2|Outcome|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
451714|NCT00617708|O1|Outcome|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
451715|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
451716|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
451717|NCT00617708|O1|Outcome|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
451718|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
451719|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
453718|NCT00619957|E1|Reported Event|Placebo Year 2|Placebo tablet once weekly Years 1 & 2
451721|NCT00617708|E2|Reported Event|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
451722|NCT00617708|E1|Reported Event|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
451723|NCT00617773|B1|Baseline|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451724|NCT00617773|P1|Participant Flow|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451725|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451726|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451727|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451728|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451729|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451730|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451731|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451732|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451733|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451734|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451735|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451736|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451737|NCT00617773|E1|Reported Event|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
451738|NCT00617851|B5|Baseline|Total|Total of all reporting groups
451739|NCT00617851|B4|Baseline|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
451740|NCT00617851|B3|Baseline|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
451741|NCT00617851|B2|Baseline|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
451742|NCT00617851|B1|Baseline|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
451743|NCT00617851|P4|Participant Flow|Comparator Influenza Vaccine|One injection of the comparator influeza virus vaccine
451744|NCT00617851|P3|Participant Flow|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influeza virus vaccine
451745|NCT00617851|P2|Participant Flow|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influeza virus vaccine
451746|NCT00617851|P1|Participant Flow|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influeza virus vaccine
451747|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
451748|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
451749|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
451750|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
451751|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
451752|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
451753|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
451754|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
451755|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
451756|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
451757|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
451758|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
451759|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
451760|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
451761|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
451762|NCT00617851|O5|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
451763|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
451764|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
451765|NCT00617851|O2|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
451766|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
451767|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
451768|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
451769|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
451770|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
451771|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
451773|NCT00617851|O5|Outcome|Comparator Influenza Vaccine (Strain A/H3N2)|One injection of the comparator influenza virus vaccine-Strain A/H3N2
451774|NCT00617851|O4|Outcome|Comparator Influenza Vaccine (Strain A/H1N1)|One injection of the comparator influenza virus vaccine-Strain A/H1N1
451775|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine-Strain B
451776|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Strain A/H3N2)|One injection of the investigational influenza virus vaccine-Strain A/H3N2
451777|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Strain A/H1N1)|One injection of the investigational influenza virus vaccine-Strain A/H1N1
451778|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
451779|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
451780|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
451781|NCT00617851|E2|Reported Event|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
451782|NCT00617851|E1|Reported Event|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
451783|NCT00617890|B5|Baseline|Total|Total of all reporting groups
451784|NCT00617890|B4|Baseline|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
451785|NCT00617890|B3|Baseline|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
451786|NCT00617890|B2|Baseline|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451787|NCT00617890|B1|Baseline|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451788|NCT00617890|P4|Participant Flow|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
451789|NCT00617890|P3|Participant Flow|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
451790|NCT00617890|P2|Participant Flow|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451791|NCT00617890|P1|Participant Flow|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451792|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
451793|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
451794|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
451795|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
451796|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
451797|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
451845|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451798|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
451799|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
451814|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
453727|NCT00619970|O1|Outcome|Children Receiving Rifaximin|2/3 Patients with CAP
451800|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451801|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451802|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
451803|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
451804|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451805|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451806|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451807|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451808|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451809|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451810|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
451811|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
451812|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451846|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451847|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
453719|NCT00619970|B4|Baseline|Total|Total of all reporting groups
451813|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451963|NCT00618371|B1|Baseline|Group 1|Group receiving raltegravir
451815|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451816|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451817|NCT00617890|O1|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
451818|NCT00617890|E4|Reported Event|Group 3: 10mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
451819|NCT00617890|E3|Reported Event|Group 2: 10mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
451820|NCT00617890|E2|Reported Event|Group 1: 10mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451821|NCT00617890|E1|Reported Event|Group 1: 0.3mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
451822|NCT00617903|B3|Baseline|Total|Total of all reporting groups
451823|NCT00617903|B2|Baseline|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451824|NCT00617903|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451825|NCT00617903|P2|Participant Flow|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451826|NCT00617903|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451827|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451828|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451829|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451830|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451831|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451832|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451833|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451834|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451835|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451836|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451837|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451838|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451839|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451840|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451841|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451842|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451843|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451844|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451848|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451849|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451850|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451851|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451852|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451853|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451854|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451855|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451856|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451857|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451858|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451859|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451860|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451861|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451862|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451863|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451864|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451865|NCT00617903|E2|Reported Event|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
451866|NCT00617903|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
451867|NCT00617929|B1|Baseline|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
451868|NCT00617929|P1|Participant Flow|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
451869|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
451870|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
451871|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
451872|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
451873|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
451874|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
451875|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
451905|NCT00618072|P3|Participant Flow|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
455441|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
451876|NCT00617929|E1|Reported Event|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
451877|NCT00617942|B3|Baseline|Total|Total of all reporting groups
451878|NCT00617942|B2|Baseline|Cohort 2|
451879|NCT00617942|B1|Baseline|Cohort 1|
451964|NCT00618371|P1|Participant Flow|Group 1|group to be treated with raltegravir
451880|NCT00617942|P2|Participant Flow|Cohort 2|"Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians"
451881|NCT00617942|P1|Participant Flow|Cohort 1|"Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14
Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians"
451882|NCT00617942|O4|Outcome|Adjuvant Cohort 2|Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
451883|NCT00617942|O3|Outcome|Adjuvant Cohort 1|Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
451884|NCT00617942|O2|Outcome|Neo-adjuvant Cohort 2|Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
451885|NCT00617942|O1|Outcome|Neo-adjuvant Cohort 1|"Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14
Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16"
451886|NCT00617942|O2|Outcome|Cohort 2|
451887|NCT00617942|O1|Outcome|Cohort 1|
451888|NCT00617942|E4|Reported Event|Adjuvant Cohort 2|Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
451889|NCT00617942|E3|Reported Event|Adjuvant Cohort 1|Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
451890|NCT00617942|E2|Reported Event|Neo-adjuvant Cohort 2|Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
451891|NCT00617942|E1|Reported Event|Neo-adjuvant Cohort 1|"Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14
Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16"
451892|NCT00617981|B3|Baseline|Total|Total of all reporting groups
451893|NCT00617981|B2|Baseline|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
5% Dextrose Solution: Single 30 minute intravenous infusion"
451894|NCT00617981|B1|Baseline|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
451895|NCT00617981|P2|Participant Flow|Sham + RFA|"Sham infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.
5% Dextrose Solution: Single 30 minute intravenous infusion"
451896|NCT00617981|P1|Participant Flow|ThermoDox + RFA|"ThermoDox should be administered at 50 mg/m2. The infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
451897|NCT00617981|O2|Outcome|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
5% Dextrose Solution: Single 30 minute intravenous infusion"
451898|NCT00617981|O1|Outcome|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
451899|NCT00617981|E2|Reported Event|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
5% Dextrose Solution: Single 30 minute intravenous infusion"
451900|NCT00617981|E1|Reported Event|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.
ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
451901|NCT00618072|B4|Baseline|Total|Total of all reporting groups
451902|NCT00618072|B3|Baseline|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
451903|NCT00618072|B2|Baseline|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
451904|NCT00618072|B1|Baseline|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
451959|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451906|NCT00618072|P2|Participant Flow|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451965|NCT00618371|O1|Outcome|Raltegravir Intensification|participants received 4 wk raltegravir intensification. Samples from 0 participants were analyzed No Patients experienced ≥ 1 log decline in viral RNA, so no samples could be analyzed
451907|NCT00618072|P1|Participant Flow|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451908|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451909|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451910|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451911|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451912|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451913|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451914|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451915|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451916|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451917|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451918|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451919|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451920|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451921|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451922|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451923|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451924|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451925|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451960|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
455442|NCT00614939|O1|Outcome|Placebo|Placebo
451926|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451927|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451928|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451929|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451930|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451931|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451932|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451933|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451934|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
451935|NCT00618072|E3|Reported Event|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
451936|NCT00618072|E2|Reported Event|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone placebo 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
451937|NCT00618072|E1|Reported Event|A: EMPOWIR and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
451938|NCT00618332|B3|Baseline|Total|Total of all reporting groups
451939|NCT00618332|B2|Baseline|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451940|NCT00618332|B1|Baseline|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
451941|NCT00618332|P2|Participant Flow|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451942|NCT00618332|P1|Participant Flow|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
451943|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451944|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
451945|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451946|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
451947|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451948|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
451949|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451950|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
451951|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451952|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
451953|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451954|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
451955|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451956|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
451957|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451958|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
451961|NCT00618332|E2|Reported Event|Placebo|"2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks"
451962|NCT00618332|E1|Reported Event|Mometasone Furoate|"2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
451966|NCT00618371|O1|Outcome|Raltegravir Intensification|participants received 4 wk raltegravir intensification
451967|NCT00618371|E1|Reported Event|Group 1|group treated with raltegravir
451968|NCT00618410|B1|Baseline|Entire Study Population|Study population includes subjects receiving interventions in either order.
451969|NCT00618410|P2|Participant Flow|Placebo, Then Carbon Dioxide|"Intervention sequence:
Intervention #1: nasal placebo administered 30 minutes prior to nasal challenge
Intervention #2: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge"
451970|NCT00618410|P1|Participant Flow|Carbon Dioxide, Then Placebo|"Intervention sequence:
Intervention #1: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
Intervention #2: nasal placebo administered 30 minutes prior to nasal challenge"
451971|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
451972|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
451973|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
451974|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
451975|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
451976|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
451977|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
451978|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
451979|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
451980|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
451981|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
451982|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
451983|NCT00618410|E2|Reported Event|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
451984|NCT00618410|E1|Reported Event|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
451985|NCT00618436|B3|Baseline|Total|Total of all reporting groups
451986|NCT00618436|B2|Baseline|Phenytoin|This group will receive treatment with Phenytoin.
451987|NCT00618436|B1|Baseline|Levetiracetam|This group will receive treatment with Levetiracetam.
451988|NCT00618436|P2|Participant Flow|Phenytoin|This group will receive treatment with Phenytoin.
451989|NCT00618436|P1|Participant Flow|Levetiracetam|This group will receive treatment with Levetiracetam.
451990|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
451991|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
451992|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
451993|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
451994|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
451995|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
451996|NCT00618436|E2|Reported Event|Phenytoin|This group will receive treatment with Phenytoin.
451997|NCT00618436|E1|Reported Event|Levetiracetam|This group will receive treatment with Levetiracetam.
451998|NCT00618449|B3|Baseline|Total|Total of all reporting groups
451999|NCT00618449|B2|Baseline|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
452000|NCT00618449|B1|Baseline|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
452001|NCT00618449|P2|Participant Flow|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
452002|NCT00618449|P1|Participant Flow|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
452003|NCT00618449|O2|Outcome|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
452165|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452004|NCT00618449|O1|Outcome|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
452167|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452005|NCT00618449|E2|Reported Event|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
452006|NCT00618449|E1|Reported Event|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
452007|NCT00618514|B3|Baseline|Total|Total of all reporting groups
452008|NCT00618514|B2|Baseline|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452009|NCT00618514|B1|Baseline|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452010|NCT00618514|P3|Participant Flow|Bright Tip Laser & Bare Tip Laser|Subjects that received testament of both limbs using the investigational device (Bright Tip laser) and the control (bare tip laser)
452011|NCT00618514|P2|Participant Flow|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this arm had only one limb treated with the bare tip laser fiber (control).
452012|NCT00618514|P1|Participant Flow|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this category had only one limb treated with the Bright tip laser fiber.
452013|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452014|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452015|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452016|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452017|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452018|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452019|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452020|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452021|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452022|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452023|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452024|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452025|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452026|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452027|NCT00618514|E2|Reported Event|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452028|NCT00618514|E1|Reported Event|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
452042|NCT00618618|B3|Baseline|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452043|NCT00618618|B2|Baseline|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452044|NCT00618618|B1|Baseline|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452168|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452029|NCT00618540|B1|Baseline|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.
alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.
(dose adjust if age <12 months)
melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
452030|NCT00618540|P1|Participant Flow|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.
alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.
(dose adjust if age <12 months)
melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
452031|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.
alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.
(dose adjust if age <12 months)
melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
452032|NCT00618540|O1|Outcome|Alemtuzumab|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.
alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.
(dose adjust if age <12 months)
melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
452033|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.
alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.
(dose adjust if age <12 months)
melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
452034|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.
alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.
(dose adjust if age <12 months)
melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
452035|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.
alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.
(dose adjust if age <12 months)
melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
452036|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.
alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.
(dose adjust if age <12 months)
melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
452037|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.
alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.
(dose adjust if age <12 months)
melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
452038|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.
alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.
(dose adjust if age <12 months)
melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
452039|NCT00618540|E1|Reported Event|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.
alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.
(dose adjust if age <12 months)
melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
452040|NCT00618618|B5|Baseline|Total|Total of all reporting groups
452041|NCT00618618|B4|Baseline|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452045|NCT00618618|P4|Participant Flow|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452046|NCT00618618|P3|Participant Flow|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452047|NCT00618618|P2|Participant Flow|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452048|NCT00618618|P1|Participant Flow|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452049|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452050|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452051|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452052|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452053|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452054|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452055|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452056|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452057|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452058|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452059|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452060|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452061|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452062|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452063|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452064|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452065|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452066|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452067|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452068|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452069|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452070|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452071|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452072|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452073|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452074|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452075|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452076|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452077|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452078|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452079|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452080|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452081|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452082|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452083|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452084|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452085|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452086|NCT00618618|O3|Outcome|0Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452087|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452088|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452089|NCT00618618|E4|Reported Event|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452090|NCT00618618|E3|Reported Event|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452091|NCT00618618|E2|Reported Event|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452092|NCT00618618|E1|Reported Event|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452093|NCT00618722|B5|Baseline|Total|Total of all reporting groups
452094|NCT00618722|B4|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452095|NCT00618722|B3|Baseline|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452096|NCT00618722|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452097|NCT00618722|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452098|NCT00618722|P4|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452099|NCT00618722|P3|Participant Flow|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452100|NCT00618722|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452101|NCT00618722|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452102|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452103|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452104|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452105|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452106|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452107|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452108|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452109|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452110|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452111|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452112|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452113|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452114|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452115|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452116|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452117|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452118|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452119|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452120|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452121|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452122|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452123|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452124|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452125|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452126|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
453720|NCT00619970|B3|Baseline|Children Receiving Placebo|1/3 patients with CAP
452127|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452128|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452129|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452130|NCT00618722|E4|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452131|NCT00618722|E3|Reported Event|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452132|NCT00618722|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452133|NCT00618722|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
452134|NCT00618748|B4|Baseline|Total|Total of all reporting groups
452135|NCT00618748|B3|Baseline|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452136|NCT00618748|B2|Baseline|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452137|NCT00618748|B1|Baseline|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452138|NCT00618748|P3|Participant Flow|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452139|NCT00618748|P2|Participant Flow|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452140|NCT00618748|P1|Participant Flow|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452141|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452142|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452143|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452144|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452145|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452146|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452147|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452148|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452149|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452150|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452151|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452152|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452153|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452154|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452155|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452156|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452157|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452158|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452159|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452160|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452161|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452162|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452163|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452164|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452166|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452169|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452170|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452171|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452172|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452173|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452174|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452175|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452176|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452177|NCT00618748|E3|Reported Event|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
452178|NCT00618748|E2|Reported Event|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452179|NCT00618748|E1|Reported Event|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
452180|NCT00618774|B3|Baseline|Total|Total of all reporting groups
452181|NCT00618774|B2|Baseline|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452182|NCT00618774|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452183|NCT00618774|P2|Participant Flow|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452184|NCT00618774|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452185|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452186|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452187|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452188|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452189|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452190|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452191|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452192|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452193|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452194|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452195|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452196|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452197|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452198|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452199|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452200|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452201|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452202|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452203|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452204|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452205|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452206|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452207|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452208|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452209|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452210|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452211|NCT00618774|E2|Reported Event|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452212|NCT00618774|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
452213|NCT00618787|B3|Baseline|Total|Total of all reporting groups
452214|NCT00618787|B2|Baseline|COPA|Regular foam dressing without Polyhexamethylene Biguanide
452215|NCT00618787|B1|Baseline|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
452216|NCT00618787|P2|Participant Flow|COPA|Regular foam dressing without Polyhexamethylene Biguanide
452217|NCT00618787|P1|Participant Flow|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
452218|NCT00618787|O2|Outcome|COPA|Regular foam dressing without Polyhexamethylene Biguanide
452219|NCT00618787|O1|Outcome|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
452220|NCT00618787|E2|Reported Event|COPA|Regular foam dressing without Polyhexamethylene Biguanide
452221|NCT00618787|E1|Reported Event|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
453721|NCT00619970|B2|Baseline|Children Receiving Rifaximin|2/3 Patients with CAP
452222|NCT00618813|B1|Baseline|Treatment (Combination Chemotherapy)|"See Detailed Description
radiation therapy: Undergo radiation therapy
therapeutic conventional surgery: Undergo surgery
etoposide: Given IV
ifosfamide: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
topotecan hydrochloride: Given IV
filgrastim: Given SC"
452267|NCT00607269|E1|Reported Event|Control|Control condition receiving minimal incentives for service program attendance and participation.
452223|NCT00618813|P1|Participant Flow|Treatment (Combination Chemotherapy)|"See Detailed Description
radiation therapy: Undergo radiation therapy
therapeutic conventional surgery: Undergo surgery
etoposide: Given IV
ifosfamide: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
topotecan hydrochloride: Given IV
filgrastim: Given SC"
452224|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description
radiation therapy: Undergo radiation therapy
therapeutic conventional surgery: Undergo surgery
etoposide: Given IV
ifosfamide: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
topotecan hydrochloride: Given IV
filgrastim: Given SC"
452225|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description
radiation therapy: Undergo radiation therapy
therapeutic conventional surgery: Undergo surgery
etoposide: Given IV
ifosfamide: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
topotecan hydrochloride: Given IV
filgrastim: Given SC"
452226|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description
radiation therapy: Undergo radiation therapy
therapeutic conventional surgery: Undergo surgery
etoposide: Given IV
ifosfamide: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
topotecan hydrochloride: Given IV
filgrastim: Given SC"
452227|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description
radiation therapy: Undergo radiation therapy
therapeutic conventional surgery: Undergo surgery
etoposide: Given IV
ifosfamide: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
topotecan hydrochloride: Given IV
filgrastim: Given SC"
452228|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description
radiation therapy: Undergo radiation therapy
therapeutic conventional surgery: Undergo surgery
etoposide: Given IV
ifosfamide: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
topotecan hydrochloride: Given IV
filgrastim: Given SC"
452229|NCT00618813|E1|Reported Event|Treatment (Combination Chemotherapy)|"See Detailed Description
radiation therapy: Undergo radiation therapy
therapeutic conventional surgery: Undergo surgery
etoposide: Given IV
ifosfamide: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
topotecan hydrochloride: Given IV
filgrastim: Given SC"
452230|NCT00618826|B1|Baseline|Treatment Period|"Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
Paclitaxel: Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.
Gemcitabine: Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.
Avastin: 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions."
452231|NCT00618826|P1|Participant Flow|Paclitaxel + Gemcitabine + Avastin|"Treatment administered once every 2 weeks, 1 cycle will consist of 14 days.
Paclitaxel (administered first) - Patients will be pre-medicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.
Gemcitabine (given after Paclitaxel) - Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.
Avastin - 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions."
452232|NCT00618826|O1|Outcome|Arm 1|all participants
452233|NCT00618826|O1|Outcome|Treatment|Paclitaxel / Gemcitabine
452234|NCT00618826|E1|Reported Event|Treatment Period|Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
452235|NCT00618839|B1|Baseline|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
452236|NCT00618839|P1|Participant Flow|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
452237|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by subsequent autografting once the wound bed has become healthy enough to accept an autograft. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
452238|NCT00618839|O1|Outcome|StrataGraft|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
452318|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
453722|NCT00619970|B1|Baseline|Healthy Control|Healthy controls
452266|NCT00607269|E2|Reported Event|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
452239|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by subsequent autografting once the wound bed has become healthy enough to accept an autograft. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
452240|NCT00618839|O1|Outcome|StrataGraft|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
452241|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by autografting once once sufficient donor skin is available for autografting. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
452242|NCT00618839|O1|Outcome|StrataGraft Skin Tissue|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
452243|NCT00618839|E1|Reported Event|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
452244|NCT00607243|B3|Baseline|Total|Total of all reporting groups
452245|NCT00607243|B2|Baseline|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
452246|NCT00607243|B1|Baseline|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
452247|NCT00607243|P2|Participant Flow|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
452248|NCT00607243|P1|Participant Flow|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
452249|NCT00607243|O2|Outcome|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
452250|NCT00607243|O1|Outcome|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
452251|NCT00607243|E2|Reported Event|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
452252|NCT00607243|E1|Reported Event|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
452253|NCT00607269|B3|Baseline|Total|Total of all reporting groups
452254|NCT00607269|B2|Baseline|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
452255|NCT00607269|B1|Baseline|Control|Control condition receiving minimal incentives for service program attendance and participation.
452256|NCT00607269|P2|Participant Flow|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
452257|NCT00607269|P1|Participant Flow|Control|Control condition receiving minimal incentives for service program attendance and participation.
452258|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
452259|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
452260|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
452261|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
452262|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
452263|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
452264|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
452265|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
452268|NCT00607321|B1|Baseline|Medtronic Bifurcation Stent System|Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
452269|NCT00607321|P1|Participant Flow|Medtronic Bifurcation Stent System|Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
452270|NCT00607321|O1|Outcome|Subjects Receiving Bifurcation Stents|
452271|NCT00607321|O1|Outcome|Bifurcation Stent System|Evaluable patients within pre-specified follow up window
452272|NCT00607321|O1|Outcome|Bifurcation Stent System|
452273|NCT00607321|O1|Outcome|Bifurcation Stent System|
452274|NCT00607321|O1|Outcome|Subjects Receiving Bifurcation Stents|
452275|NCT00607321|E1|Reported Event|1. Branch Bifurcation Stent System|All subjects enrolled in the BRANCH study
452276|NCT00607373|B3|Baseline|Total|Total of all reporting groups
452277|NCT00607373|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452278|NCT00607373|B1|Baseline|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452279|NCT00607373|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452280|NCT00607373|P1|Participant Flow|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452281|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452282|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452283|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452284|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452285|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452286|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452287|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452288|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452289|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452290|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452291|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452292|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452293|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452294|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452295|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452296|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452297|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452298|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452299|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452300|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452301|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452302|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452303|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452304|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452305|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452306|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452307|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452308|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452309|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452310|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452311|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452312|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452313|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452314|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452315|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452316|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452317|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452319|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452320|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452321|NCT00607373|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
452322|NCT00607373|E1|Reported Event|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
452323|NCT00607386|B1|Baseline|Idursulfase|Open-label treatment with idursulfase
452324|NCT00607386|P1|Participant Flow|Idursulfase|Open-label treatment with idursulfase
452325|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
452326|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
452327|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
452328|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
452329|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
452330|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
452331|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
452332|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
452333|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
452334|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
452335|NCT00607386|E1|Reported Event|Idursulfase|Open-label treatment with idursulfase
452336|NCT00607477|B3|Baseline|Total|Total of all reporting groups
452337|NCT00607477|B2|Baseline|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
452338|NCT00607477|B1|Baseline|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
452339|NCT00607477|P2|Participant Flow|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
452340|NCT00607477|P1|Participant Flow|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
452341|NCT00607477|O2|Outcome|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
452342|NCT00607477|O1|Outcome|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
452343|NCT00607477|E2|Reported Event|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
452344|NCT00607477|E1|Reported Event|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
452345|NCT00607594|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
452346|NCT00607594|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
452347|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.
saracatinib: Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity."
452348|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.
saracatinib: Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity."
452349|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
452350|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
452351|NCT00607594|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
saracatinib
laboratory biomarker analysis: Correlative studies"
452352|NCT00607672|B4|Baseline|Total|Total of all reporting groups
452353|NCT00607672|B3|Baseline|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
452354|NCT00607672|B2|Baseline|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
452355|NCT00607672|B1|Baseline|Placebo|Patients are randomized to placebo prior to surgery
452356|NCT00607672|P3|Participant Flow|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
452357|NCT00607672|P2|Participant Flow|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
452358|NCT00607672|P1|Participant Flow|Placebo|Patients are randomized to placebo prior to surgery
452359|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
452360|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
452361|NCT00607672|O1|Outcome|Placebo|Placebo group
452362|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
452363|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
452364|NCT00607672|O1|Outcome|Placebo|Placebo group
452365|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
452366|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
452367|NCT00607672|O1|Outcome|Placebo|Placebo group
452368|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
452369|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
452370|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
452371|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
456361|NCT00623714|B1|Baseline|All Patients|All Randomized Patients
452374|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
452375|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
452376|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
452377|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
452378|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
452379|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
452380|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
452381|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
452382|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
452383|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
452384|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
452385|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
452386|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
452387|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
452388|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
452389|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
452390|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
452391|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
452392|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
452393|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
452394|NCT00607672|O1|Outcome|Placebo|Placebo group
452395|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
452396|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
452397|NCT00607672|O1|Outcome|Placebo|Placebo group
452398|NCT00607672|E3|Reported Event|Candesartan (ARB)|Angiotensin receptor blocker group
452399|NCT00607672|E2|Reported Event|Ramipril (ACEI)|Angiotensin-converting enzyme group
452400|NCT00607672|E1|Reported Event|Placebo|Placebo group
452401|NCT00607724|B8|Baseline|Total|Total of all reporting groups
452402|NCT00607724|B7|Baseline|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability
452403|NCT00607724|B6|Baseline|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452404|NCT00607724|B5|Baseline|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452405|NCT00607724|B4|Baseline|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452406|NCT00607724|B3|Baseline|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452407|NCT00607724|B2|Baseline|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452408|NCT00607724|B1|Baseline|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452409|NCT00607724|P7|Participant Flow|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452410|NCT00607724|P6|Participant Flow|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452411|NCT00607724|P5|Participant Flow|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452412|NCT00607724|P4|Participant Flow|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with basal cell carcinoma (BCC) received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452413|NCT00607724|P3|Participant Flow|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452414|NCT00607724|P2|Participant Flow|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452438|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452439|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452415|NCT00607724|P1|Participant Flow|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 milligram (mg) on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0), maximum benefit, or intolerability.
452416|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452417|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452418|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452419|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452420|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452421|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452422|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452423|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452424|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452425|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452426|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452427|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452428|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452429|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452430|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452431|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452432|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452433|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452434|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452435|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452436|NCT00607724|O6|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452437|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452440|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452441|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452442|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452443|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452444|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452445|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452446|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452447|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452448|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452449|NCT00607724|O1|Outcome|All Participants|Included all participants from Stage 1 and Stage 2.
452450|NCT00607724|O1|Outcome|Stage 1: GDC-0449|Included participants with any tumor who received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg, 270 mg and 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, 270 mg and 540 mg orally, continuing until disease progression, maximum benefit, or intolerability.
452451|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452452|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452453|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452454|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452455|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452456|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452457|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452458|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452459|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452460|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452461|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452549|NCT00608881|P2|Participant Flow|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452462|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452463|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452464|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452465|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452466|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452467|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452468|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452469|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452470|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452471|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
452472|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452473|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452474|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452475|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452476|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452477|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452478|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452479|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452480|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452481|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452482|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
452483|NCT00607724|E7|Reported Event|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
452484|NCT00607724|E6|Reported Event|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants with tolerable safety, pharmacokinetic and pharmacodynamic data from Stage 1 received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
452485|NCT00607724|E5|Reported Event|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1 until disease progression, maximum benefit, or intolerability.
452486|NCT00607724|E4|Reported Event|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
452487|NCT00607724|E3|Reported Event|Stage 1: GDC-0449 (540 mg)|Participants received single dose of GDC-0449 hard gelatin capsules at 540 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
452488|NCT00607724|E2|Reported Event|Stage 1: GDC-0449 (270 mg)|Stage 1: GDC-0449 (270 mg) Participants received single dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
452489|NCT00607724|E1|Reported Event|Stage 1: GDC-0449 (150 mg)|Participants received single dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1, thereafter Day 8 received daily until disease progression, maximum benefit, or intolerability.
452490|NCT00608777|B1|Baseline|Open Label Taclonex|
452491|NCT00608777|P1|Participant Flow|Open Label Taclonex|
452492|NCT00608777|O1|Outcome|Open Label Taclonex|
452493|NCT00608777|E1|Reported Event|Open Label|
452494|NCT00608829|B1|Baseline|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
452495|NCT00608829|P1|Participant Flow|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
452496|NCT00608829|O1|Outcome|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
452497|NCT00608829|E1|Reported Event|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
452498|NCT00608842|B5|Baseline|Total|Total of all reporting groups
452499|NCT00608842|B4|Baseline|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452500|NCT00608842|B3|Baseline|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452501|NCT00608842|B2|Baseline|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452502|NCT00608842|B1|Baseline|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452503|NCT00608842|P4|Participant Flow|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452504|NCT00608842|P3|Participant Flow|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452505|NCT00608842|P2|Participant Flow|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452506|NCT00608842|P1|Participant Flow|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452507|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452508|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452509|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452510|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452511|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452512|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452513|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452514|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
456429|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
452515|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452516|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452517|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452518|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452519|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452520|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452521|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452522|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452523|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452524|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452525|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452526|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452527|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452528|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452529|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452530|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452531|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452532|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452533|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452534|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452535|NCT00608842|E4|Reported Event|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452536|NCT00608842|E3|Reported Event|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452537|NCT00608842|E2|Reported Event|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452538|NCT00608842|E1|Reported Event|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
452539|NCT00608868|B1|Baseline|Gefitinib|gefitinib tablet 250 mg orally
452540|NCT00608868|P1|Participant Flow|Gefitinib|gefitinib tablet 250 mg orally
452541|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
452542|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
452543|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
452544|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
452545|NCT00608868|E1|Reported Event|Gefitinib|gefitinib tablet 250 mg orally
452546|NCT00608881|B3|Baseline|Total|Total of all reporting groups
452547|NCT00608881|B2|Baseline|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452548|NCT00608881|B1|Baseline|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452550|NCT00608881|P1|Participant Flow|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452552|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452553|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452554|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452555|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452556|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452557|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452558|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452559|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452560|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452561|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452562|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452563|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452564|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452565|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452566|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452567|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452568|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452569|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452570|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452571|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452572|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452573|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452574|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452575|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452576|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452577|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452578|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452579|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452580|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452581|NCT00608881|E2|Reported Event|B - Placebo|"Randomized to placebo
placebo: an inactive substance"
452582|NCT00608881|E1|Reported Event|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)
coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
452583|NCT00608907|B4|Baseline|Total|Total of all reporting groups
452584|NCT00608907|B3|Baseline|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
452585|NCT00608907|B2|Baseline|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
452586|NCT00608907|B1|Baseline|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
452587|NCT00608907|P3|Participant Flow|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
452588|NCT00608907|P2|Participant Flow|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
452589|NCT00608907|P1|Participant Flow|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
452590|NCT00608907|O3|Outcome|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
452591|NCT00608907|O2|Outcome|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
452592|NCT00608907|O1|Outcome|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
452593|NCT00608907|E3|Reported Event|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
452594|NCT00608907|E2|Reported Event|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
452595|NCT00608907|E1|Reported Event|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
452596|NCT00608959|B3|Baseline|Total|Total of all reporting groups
452597|NCT00608959|B2|Baseline|Chlorhexidine 2% (CHG) / Omiganan 1% Gel(Part 1)|25 subjects were treated with chlorhexidine 2% and omiganan 1% in Part 1.
452598|NCT00608959|B1|Baseline|Omiganan 1% Gel (Part 2)|25 subjects were treated with omiganan 1% gel at skin and intravenous (IV) sites in Part 2.
452599|NCT00608959|P1|Participant Flow|Omiganan 1% Gel and Chlorhexidine|"In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen and chlorhexidine applied to 6 matching sites on the contralateral side.Swab cultures were taken at specified timepoints over 72 hours.
In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Swab cultures were taken at specified timepoints over 7 days.In addition subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with isopropyl alcohol (prior to insertion) and omiganan 1% gel was applied. Catheter tip samples were taken at pre-specified timepoints over the 7 day period."
452600|NCT00608959|O2|Outcome|Chlorhexidine 2%/ Isopropyl Alcohol|Subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with chlorhexidine/isopropyl alcohol prior to catheter insertion.Catheter tip samples were taken at pre-specified timepoints over the 7 day period.
452601|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with isopropyl alcohol (prior to insertion) and omiganan 1% gel was applied. Catheter tip samples were taken at pre-specified timepoints over the 7 day period.
452602|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 7 days.
452603|NCT00608959|O2|Outcome|Chlorhexidine 2%(Part 1)|Chlorhexidine 2% solution was applied to 6 sites on the chest and/or abdomen. Swab cultures were obtained at specific timepoints over 3 days.
452604|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 3 days.
452605|NCT00608959|E3|Reported Event|Omiganan 1% (Part 2)|In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Omiganan 1% gel was applied to one intravenous (IV) catheter site.
452606|NCT00608959|E2|Reported Event|Chlorhexidine|In Part 1 each subject had chlorhexidine 2% applied to 6 sites located across the chest and/or abdomen. In Part 2 subjects had chlorhexidine 2%/isopropyl alcohol applied to one intravenous (IV) catheter site.
452607|NCT00608959|E1|Reported Event|Omiganan 1% Gel (Part 1)|In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen.
452608|NCT00608985|B5|Baseline|Total|Total of all reporting groups
452609|NCT00608985|B4|Baseline|Zolpidem 10mg|"zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
452610|NCT00608985|B3|Baseline|Almorexant 200mg|"almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
452611|NCT00608985|B2|Baseline|Almorexant 100mg|"almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
452612|NCT00608985|B1|Baseline|Placebo|"Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
452613|NCT00608985|P4|Participant Flow|Zolpidem 10mg|"zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
452614|NCT00608985|P3|Participant Flow|Almorexant 200mg|"almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
452615|NCT00608985|P2|Participant Flow|Almorexant 100mg|"almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
452616|NCT00608985|P1|Participant Flow|Placebo|"Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
452617|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
452618|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
452619|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
452620|NCT00608985|O1|Outcome|Placebo|"Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
452621|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
452622|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
452623|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
452624|NCT00608985|O1|Outcome|Placebo|"Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
452625|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
452626|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
452627|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
452628|NCT00608985|O1|Outcome|Placebo|"Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
452629|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
452630|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
452631|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
452632|NCT00608985|O1|Outcome|Placebo|"Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
452633|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
452634|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
452635|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
452636|NCT00608985|O1|Outcome|Placebo|"Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
452637|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
452638|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
452639|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
452640|NCT00608985|O1|Outcome|Placebo|"Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
452641|NCT00608985|E4|Reported Event|Zolpidem 10mg|"zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
452642|NCT00608985|E3|Reported Event|Almorexant 200mg|"almorexant 200 mg
almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
452643|NCT00608985|E2|Reported Event|Almorexant 100mg|"almorexant 100 mg
almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
452644|NCT00608985|E1|Reported Event|Placebo|"Placebo
Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
452645|NCT00609167|B3|Baseline|Total|Total of all reporting groups
452646|NCT00609167|B2|Baseline|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
452647|NCT00609167|B1|Baseline|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
452648|NCT00609167|P2|Participant Flow|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
452649|NCT00609167|P1|Participant Flow|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
452650|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
452651|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
452652|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
452653|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
452654|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
452655|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
452656|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
452657|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
452658|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
452659|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
452660|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
452661|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
452662|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
452663|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
452664|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
452665|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
453723|NCT00619970|P3|Participant Flow|Children Receiving Placebo|1/3 patients with CAP
453055|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
452666|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
452667|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11
Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22
Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
452668|NCT00609167|E2|Reported Event|CyBorD (Bortezomib 1.5mg/m^2)|Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22
452669|NCT00609167|E1|Reported Event|CyBorD (Bortezomib 1.3mg/m^2)|Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
452670|NCT00609245|B1|Baseline|Valproate Infusion|"placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.
Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003)."
452671|NCT00609245|P1|Participant Flow|Valproate Infusion|"placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.
Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003)."
452672|NCT00609245|O2|Outcome|Valproic Acid|The investigators will utilize intravenous sodium valproate. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
452673|NCT00609245|O1|Outcome|Placebo|Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration.
452674|NCT00609245|E2|Reported Event|Placebo|placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.
452675|NCT00609245|E1|Reported Event|Valproic Acid|Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
452676|NCT00609336|B1|Baseline|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies"
452677|NCT00609336|P1|Participant Flow|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
gemcitabine: Given IV
oxaliplatin: Given IV"
452678|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
gemcitabine: Given IV
oxaliplatin: Given IV"
452679|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies"
452680|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies"
452681|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies"
452682|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies"
452683|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies"
452684|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies"
452685|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies"
453724|NCT00619970|P2|Participant Flow|Children Receiving Rifaximin|2/3 Patients with CAP
452686|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies"
452687|NCT00609336|E1|Reported Event|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
gemcitabine: Given IV
oxaliplatin: Given IV"
452688|NCT00609362|B3|Baseline|Total|Total of all reporting groups
452689|NCT00609362|B2|Baseline|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
452690|NCT00609362|B1|Baseline|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
452691|NCT00609362|P2|Participant Flow|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
452692|NCT00609362|P1|Participant Flow|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
452693|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
452694|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
452695|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
452696|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
452697|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
452698|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
452699|NCT00609362|E2|Reported Event|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
452700|NCT00609362|E1|Reported Event|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
452701|NCT00609466|B4|Baseline|Total|Total of all reporting groups
452702|NCT00609466|B3|Baseline|Placebo|Matching Placebo 4 to 6 hourly
452703|NCT00609466|B2|Baseline|Morphine|Morphine IR 30mg 4 to 6 hourly
452704|NCT00609466|B1|Baseline|CG5503|CG5503 IR 75mg 4-6 hourly
452705|NCT00609466|P3|Participant Flow|Placebo|Matching Placebo 4 to 6 hourly
452706|NCT00609466|P2|Participant Flow|Morphine|Morphine IR 30mg 4 to 6 hourly
452707|NCT00609466|P1|Participant Flow|CG5503|CG5503 IR 75mg 4-6 hourly
452708|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
452709|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
452710|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
452711|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
452712|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
452713|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
452714|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
452715|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
452716|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
452717|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
452718|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
452719|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
452720|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
452721|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
452722|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
452723|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
452724|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
452725|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
452726|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
452727|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
452728|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
452729|NCT00609466|E3|Reported Event|Placebo|Matching Placebo 4 to 6 hourly
452730|NCT00609466|E2|Reported Event|Morphine|Morphine IR 30mg 4 to 6 hourly
452731|NCT00609466|E1|Reported Event|CG5503|CG5503 IR 75mg 4-6 hourly
452732|NCT00609492|B4|Baseline|Total|Total of all reporting groups
452733|NCT00609492|B3|Baseline|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452734|NCT00609492|B2|Baseline|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452735|NCT00609492|B1|Baseline|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452736|NCT00609492|P3|Participant Flow|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
453053|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
452737|NCT00609492|P2|Participant Flow|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452738|NCT00609492|P1|Participant Flow|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452739|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452740|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452741|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452742|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452743|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452744|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452745|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452746|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452747|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452748|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452749|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid
452750|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452751|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452752|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
453089|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
452753|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452754|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452755|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452756|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452757|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452758|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452759|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452760|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452761|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452762|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452763|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452764|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452765|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452766|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452767|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452768|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
453129|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
452769|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452770|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452771|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452772|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452773|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452774|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452775|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452776|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452777|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452778|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452779|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452780|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452781|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452782|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452783|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452784|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
453213|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
452785|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452786|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452787|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452788|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452789|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452790|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452791|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452792|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452793|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452794|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452795|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452796|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452797|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452798|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452799|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452800|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
453259|NCT00610688|B2|Baseline|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
452801|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452802|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452803|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452804|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452805|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452806|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452807|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452808|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452809|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452810|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452811|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452812|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452813|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452814|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452815|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452816|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
453725|NCT00619970|P1|Participant Flow|Healthy Control|Healthy controls
452817|NCT00609492|E2|Reported Event|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452818|NCT00609492|E1|Reported Event|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
452819|NCT00609518|B3|Baseline|Total|Total of all reporting groups
452820|NCT00609518|B2|Baseline|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
452821|NCT00609518|B1|Baseline|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
452822|NCT00609518|P2|Participant Flow|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
452823|NCT00609518|P1|Participant Flow|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
452824|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
452825|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
452826|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
452827|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
452828|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
452829|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
452830|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
452831|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
452832|NCT00609518|E2|Reported Event|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
452833|NCT00609518|E1|Reported Event|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
452834|NCT00609622|B3|Baseline|Total|Total of all reporting groups
452835|NCT00609622|B2|Baseline|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452836|NCT00609622|B1|Baseline|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452837|NCT00609622|P2|Participant Flow|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kilogram (mg/kg) administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and a 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452838|NCT00609622|P1|Participant Flow|Sunitinib + mFOLFOX6|Sunitinib 37.5 milligram (mg) capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, lecovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg per square meter (mg/m^2) and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour intravenous (IV) infusion followed by an IV bolus of 5-fluorouracil (5-FU) 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452909|NCT00609804|P2|Participant Flow|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452839|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452840|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452841|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452842|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452843|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452844|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452845|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452846|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452847|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452848|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452849|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452850|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452851|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452852|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452853|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452854|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452940|NCT00609973|E1|Reported Event|Cipro|Ciprofloxacin 500 mg bid
452941|NCT00609986|B3|Baseline|Total|Total of all reporting groups
452855|NCT00609622|E2|Reported Event|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452856|NCT00609622|E1|Reported Event|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
452857|NCT00609674|B3|Baseline|Total|Total of all reporting groups
452858|NCT00609674|B2|Baseline|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452859|NCT00609674|B1|Baseline|Placebo|Placebo nasal spray
452860|NCT00609674|P2|Participant Flow|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452861|NCT00609674|P1|Participant Flow|Placebo|Placebo nasal spray
452862|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452863|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452864|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452865|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452866|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452867|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452868|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452869|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452870|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452871|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452872|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452873|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452874|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452875|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452876|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452877|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452878|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452879|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452880|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452881|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452882|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452883|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452884|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452885|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452886|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452887|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452888|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452889|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452890|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452891|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
452892|NCT00609674|E2|Reported Event|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
452893|NCT00609674|E1|Reported Event|Placebo|Placebo nasal spray
452894|NCT00609739|B1|Baseline|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
452895|NCT00609739|P1|Participant Flow|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
452896|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
452897|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
452898|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
452899|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
452900|NCT00609739|E1|Reported Event|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
452901|NCT00609765|B1|Baseline|Chemotherapy|Prospective, single arm, Phase II
452902|NCT00609765|P1|Participant Flow|Chemotherapy|Prospective, single arm, Phase II
452903|NCT00609765|O1|Outcome|Chemotherapy|Prospective, single arm, Phase II
452904|NCT00609765|O1|Outcome|Chemotherapy|Prospective, single arm, Phase II
452905|NCT00609765|E1|Reported Event|Chemotherapy|Prospective, single arm, Phase II
452906|NCT00609804|B3|Baseline|Total|Total of all reporting groups
452907|NCT00609804|B2|Baseline|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452908|NCT00609804|B1|Baseline|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452910|NCT00609804|P1|Participant Flow|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452911|NCT00609804|O2|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452912|NCT00609804|O1|Outcome|Sorafenib and Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452913|NCT00609804|O2|Outcome|Sorafenib|Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452914|NCT00609804|O1|Outcome|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452915|NCT00609804|O2|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452916|NCT00609804|O1|Outcome|Sorafenib+Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452917|NCT00609804|E2|Reported Event|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452918|NCT00609804|E1|Reported Event|Sorafenib+Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
452919|NCT00609869|B1|Baseline|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
452920|NCT00609869|P1|Participant Flow|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
452921|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
452922|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
452923|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
452924|NCT00609869|E1|Reported Event|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
452925|NCT00609947|B1|Baseline|Endeavor Zotarolimus-Eluting Coronary Stent|Zotarolimus-eluting stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
452926|NCT00609947|P1|Participant Flow|Endeavor Zotarolimus-Eluting Coronary Stent|Zotarolimus-eltuing stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
452927|NCT00609947|O1|Outcome|Primary Analysis Endpoint|
452928|NCT00609947|O1|Outcome|Primary Effectiveness Analysis Endpoint - SVS|The 8-month in-segment diameter stenosis from Endeavor Small Vessel Study (SVS) subects
452929|NCT00609947|E1|Reported Event|Primary Analysis Endpoint|"The first 97 subjects enrolled and implanted with 2.25mm stents
The first 39 subjects enrolled and implanted with 2.5mm stents
The first 40 subjects enrolled and implanted with 2.75mm stents
A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)"
452930|NCT00609973|B3|Baseline|Total|Total of all reporting groups
452931|NCT00609973|B2|Baseline|Placebo|Placebo bid
452932|NCT00609973|B1|Baseline|Cipro|Ciprofloxacin 500 mg bid
452933|NCT00609973|P2|Participant Flow|Placebo|Placebo bid
452934|NCT00609973|P1|Participant Flow|Cipro|Ciprofloxacin 500 mg bid
452935|NCT00609973|O2|Outcome|Placebo|Placebo bid
452936|NCT00609973|O1|Outcome|Cipro|Ciprofloxacin 500 mg bid
452937|NCT00609973|O2|Outcome|Placebo|Placebo bid
452938|NCT00609973|O1|Outcome|Cipro|Ciprofloxacin 500 mg bid
452939|NCT00609973|E2|Reported Event|Placebo|Placebo bid
452942|NCT00609986|B2|Baseline|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
452943|NCT00609986|B1|Baseline|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
452944|NCT00609986|P2|Participant Flow|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
452945|NCT00609986|P1|Participant Flow|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
452946|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
452947|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
452948|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
452949|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
452950|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
452951|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
452952|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
452953|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
452954|NCT00609986|E2|Reported Event|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
452955|NCT00609986|E1|Reported Event|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
452956|NCT00610129|B1|Baseline|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
452957|NCT00610129|P1|Participant Flow|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
452958|NCT00610129|O1|Outcome|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
452959|NCT00610129|E1|Reported Event|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
452960|NCT00610155|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
452961|NCT00610155|P6|Participant Flow|Tramadol Then Pregabalin Then Placebo|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then matching placebo capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
452962|NCT00610155|P5|Participant Flow|Placebo Then Tramadol Then Pregabalin|Matching placebo capsule orally for 7 days in first intervention period; followed by tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
452963|NCT00610155|P4|Participant Flow|Pregabalin Then Placebo Then Tramadol|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
452964|NCT00610155|P3|Participant Flow|Placebo Then Pregabalin Then Tramadol|Matching placebo capsule orally for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
453010|NCT00610155|E2|Reported Event|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
453011|NCT00610155|E1|Reported Event|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
452965|NCT00610155|P2|Participant Flow|Tramadol Then Placebo Then Pregabalin|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
452966|NCT00610155|P1|Participant Flow|Pregabalin Then Tramadol Then Placebo|Pregabalin (PGB) capsule titrated to 150 milligram (mg) orally twice daily for 7 days in first intervention period; followed by tramadol (TMD) sustained release (SR) capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then matching placebo (PBO) capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
452967|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
452968|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
452969|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
452970|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
452971|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
452972|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
452973|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
452974|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
452975|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
452976|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
452977|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
452978|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
452979|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
452980|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
452981|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
452982|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
452983|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
452984|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
452985|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
452986|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
452987|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
452988|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
452989|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
452990|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
452991|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
452992|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
452993|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
452994|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
452995|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
452996|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
452997|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
452998|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
452999|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
453000|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
453001|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
453002|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
453003|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
453004|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
453005|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
453006|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
453007|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
453008|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
453009|NCT00610155|E3|Reported Event|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
453013|NCT00610168|B2|Baseline|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453014|NCT00610168|B1|Baseline|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453015|NCT00610168|P2|Participant Flow|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453016|NCT00610168|P1|Participant Flow|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453017|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
453018|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
453019|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
453020|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
453021|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453022|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453023|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453024|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453025|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453026|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453027|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453028|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453029|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453030|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453031|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453032|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
453033|NCT00610168|E1|Reported Event|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
453034|NCT00610207|B1|Baseline|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.
Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
453035|NCT00610207|P1|Participant Flow|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.
Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
453036|NCT00610207|O1|Outcome|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.
Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
453054|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
456430|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
453037|NCT00610207|O1|Outcome|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.
Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
453038|NCT00610207|E1|Reported Event|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.
Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
453039|NCT00610311|B1|Baseline|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.
3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)– 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
453040|NCT00610311|P1|Participant Flow|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.
3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)– 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
453041|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.
3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
453042|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.
3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
453043|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.
3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
453044|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.
3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
453045|NCT00610311|E1|Reported Event|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.
Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
453046|NCT00610363|B3|Baseline|Total|Total of all reporting groups
453047|NCT00610363|B2|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
453048|NCT00610363|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
453049|NCT00610363|P2|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
453050|NCT00610363|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 16.
453051|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
453052|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
453056|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
453057|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
453058|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
453059|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
453060|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
453061|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
453062|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
453063|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
453064|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
453065|NCT00610363|E2|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
453066|NCT00610363|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
453067|NCT00610441|B5|Baseline|Total|Total of all reporting groups
453068|NCT00610441|B4|Baseline|PBO→MK-8777 RD|Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
453069|NCT00610441|B3|Baseline|MK-8777 RD→PBO|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
453070|NCT00610441|B2|Baseline|PBO→MK-8777 FD|Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
453071|NCT00610441|B1|Baseline|MK-8777 FD→PBO|Participants receive a fixed dose FD of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
453072|NCT00610441|P4|Participant Flow|PBO→MK-8777 RD|Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
453073|NCT00610441|P3|Participant Flow|MK-8777 RD→PBO|Participants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
453074|NCT00610441|P2|Participant Flow|PBO→MK-8777 FD|Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
453075|NCT00610441|P1|Participant Flow|MK-8777 FD→PBO|Participants receive a fixed dose (FD) of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
453076|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453077|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453078|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453079|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453080|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453081|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453082|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453083|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453084|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453085|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453086|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453087|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453088|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
456431|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
453090|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453091|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453092|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453093|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453094|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453095|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453096|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453097|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453098|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453099|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453100|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453101|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453102|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453103|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453104|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453105|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453106|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453107|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453108|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453109|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453110|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453111|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453112|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453113|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453114|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453115|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453116|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453117|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453118|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453119|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453120|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453121|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453122|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453123|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453124|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453125|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453126|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453127|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453128|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
456432|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
453130|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453131|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453132|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453133|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453134|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453135|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453136|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453137|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453138|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453139|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453140|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453141|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453142|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453143|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453144|NCT00610441|O3|Outcome|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks.
453145|NCT00610441|O2|Outcome|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks.
453146|NCT00610441|O1|Outcome|Placebo|Participants receive placebo BID for 3 weeks.
453147|NCT00610441|O3|Outcome|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks.
453148|NCT00610441|O2|Outcome|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks.
453149|NCT00610441|O1|Outcome|Placebo|Participants receive placebo BID for 3 weeks.
453150|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453151|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453152|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453153|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453154|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453155|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453156|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453157|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453158|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
453159|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453160|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
453161|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
453162|NCT00610441|E3|Reported Event|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for up to 3 weeks.
453163|NCT00610441|E2|Reported Event|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for up to 3 weeks.
453164|NCT00610441|E1|Reported Event|Placebo|Participants receive placebo BID for up to 5 weeks.
453165|NCT00610532|B1|Baseline|All Study Participants|All study participants progressed from intravenous phenytoin alone to intravenous phenytoin plus probenecid
453166|NCT00610532|P1|Participant Flow|All Study Participants|All study participants progressed from receiving intravenous phenytoin alone to intravenous phenytoin plus probenecid.
453167|NCT00610532|O2|Outcome|Intravenous Phenytoin Plus Probenecid|intravenous phenytoin plus probenecid
453168|NCT00610532|O1|Outcome|Intravenous Phenytoin Alone|intravenous phenytoin alone
453169|NCT00610532|E2|Reported Event|Intravenous Phenytoin Plus Probenecid|intravenous phenytoin plus probenecid
453170|NCT00610532|E1|Reported Event|Intravenous Phenytoin Alone|intravenous phenytoin alone
453171|NCT00610649|B12|Baseline|Total|Total of all reporting groups
453172|NCT00610649|B11|Baseline|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
453173|NCT00610649|B10|Baseline|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
453174|NCT00610649|B9|Baseline|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
453175|NCT00610649|B8|Baseline|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
453176|NCT00610649|B7|Baseline|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
453177|NCT00610649|B6|Baseline|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
453178|NCT00610649|B5|Baseline|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
453179|NCT00610649|B4|Baseline|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
453180|NCT00610649|B3|Baseline|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
453181|NCT00610649|B2|Baseline|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
453182|NCT00610649|B1|Baseline|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
453183|NCT00610649|P11|Participant Flow|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
453184|NCT00610649|P10|Participant Flow|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
453185|NCT00610649|P9|Participant Flow|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg once daily (QD). Participants receive MK-8777 for a total of 28 days.
453186|NCT00610649|P8|Participant Flow|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
453187|NCT00610649|P7|Participant Flow|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
453188|NCT00610649|P6|Participant Flow|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
453189|NCT00610649|P5|Participant Flow|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
453190|NCT00610649|P4|Participant Flow|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
453191|NCT00610649|P3|Participant Flow|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
453192|NCT00610649|P2|Participant Flow|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
453193|NCT00610649|P1|Participant Flow|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg twice daily (BID) and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
453194|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
453195|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
453196|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
453197|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
453198|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
453199|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
453200|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
453201|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
453202|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
453203|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
453204|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
453205|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
453206|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
453207|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
453208|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
453209|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
453210|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
453211|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
453212|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
456433|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
453214|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
453215|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
453216|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
453217|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
453218|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
453219|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
453220|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
453221|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
453222|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
453223|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
453224|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
453225|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
453226|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
453227|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
453228|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
453229|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
453230|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
453231|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
453232|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
453233|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
453234|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
453235|NCT00610649|E11|Reported Event|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
453236|NCT00610649|E10|Reported Event|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
453237|NCT00610649|E9|Reported Event|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
453238|NCT00610649|E8|Reported Event|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
453239|NCT00610649|E7|Reported Event|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
453240|NCT00610649|E6|Reported Event|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
453241|NCT00610649|E5|Reported Event|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
453242|NCT00610649|E4|Reported Event|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
453243|NCT00610649|E3|Reported Event|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
453244|NCT00610649|E2|Reported Event|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
453245|NCT00610649|E1|Reported Event|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
453246|NCT00610675|B1|Baseline|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
453247|NCT00610675|P1|Participant Flow|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
453248|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
453249|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
453250|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
453251|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
453252|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
453253|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
453254|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
453255|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
453256|NCT00610675|E1|Reported Event|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
453257|NCT00610688|B4|Baseline|Total|Total of all reporting groups
453258|NCT00610688|B3|Baseline|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
453260|NCT00610688|B1|Baseline|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
453728|NCT00619970|O3|Outcome|Children Receiving Placebo|1/3 patients with CAP
453261|NCT00610688|P3|Participant Flow|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
453262|NCT00610688|P2|Participant Flow|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
453263|NCT00610688|P1|Participant Flow|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
453264|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
453265|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
453266|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
453267|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
453268|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
453269|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
453270|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
453271|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
453272|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
453273|NCT00610688|E3|Reported Event|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
453274|NCT00610688|E2|Reported Event|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
453275|NCT00610688|E1|Reported Event|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
453276|NCT00610701|B3|Baseline|Total|Total of all reporting groups
453277|NCT00610701|B2|Baseline|2-lateral Pin Placement|"Lateral
Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
453278|NCT00610701|B1|Baseline|1-anterior Pin Placement|"Anterior
Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
453279|NCT00610701|P2|Participant Flow|2 Lateral|"Lateral
Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
453280|NCT00610701|P1|Participant Flow|1 Anterior|"Anterior
Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
453281|NCT00610701|O2|Outcome|2-lateral Pin Placement|"Lateral
Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
453282|NCT00610701|O1|Outcome|1-anterior Pin Placement|"Anterior
Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
453283|NCT00610701|E2|Reported Event|2 Lateral|"Lateral
Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
453284|NCT00610701|E1|Reported Event|1 Anterior|"Anterior
Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
453285|NCT00610714|B3|Baseline|Total|Total of all reporting groups
453286|NCT00610714|B2|Baseline|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
453287|NCT00610714|B1|Baseline|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
453288|NCT00610714|P2|Participant Flow|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
453289|NCT00610714|P1|Participant Flow|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
453290|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
453291|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
453292|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
453293|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
453294|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
453295|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
453296|NCT00610714|E2|Reported Event|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
453343|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453387|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453297|NCT00610714|E1|Reported Event|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
453298|NCT00610740|B1|Baseline|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
453299|NCT00610740|P1|Participant Flow|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
453300|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
453301|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
453302|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
453303|NCT00610740|E1|Reported Event|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
453304|NCT00610857|B1|Baseline|Interferon Alfa-2b + Tremelimumab|Patients treated with Tremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
453305|NCT00610857|P1|Participant Flow|Interferon Alfa-2b + Tremelimumab|Patients with stage IV melanoma (cutaneous, uveal, or mucosal) and measurable disease, most who had previously received therapy
453306|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
453307|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
453308|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
453309|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
453310|NCT00610857|E1|Reported Event|Interferon Alfa-2b + Tremelimumab (Related and Unrelated AEs)|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks per cycle.
453311|NCT00610883|B1|Baseline|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
453312|NCT00610883|P1|Participant Flow|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
453313|NCT00610883|O1|Outcome|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
453314|NCT00610883|E1|Reported Event|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
453315|NCT00610987|B3|Baseline|Total|Total of all reporting groups
453316|NCT00610987|B2|Baseline|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin
Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
453341|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453342|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453507|NCT00619151|O2|Outcome|St.Jude Valve|St. Jude Medical Regent Valve
453317|NCT00610987|B1|Baseline|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.
cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
453318|NCT00610987|P2|Participant Flow|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin
Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
453319|NCT00610987|P1|Participant Flow|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.
cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
453320|NCT00610987|O2|Outcome|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin
Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
453321|NCT00610987|O1|Outcome|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.
cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
453322|NCT00610987|E2|Reported Event|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin
Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
453323|NCT00610987|E1|Reported Event|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.
cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
453324|NCT00611026|B4|Baseline|Total|Total of all reporting groups
453325|NCT00611026|B3|Baseline|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453326|NCT00611026|B2|Baseline|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453327|NCT00611026|B1|Baseline|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453328|NCT00611026|P3|Participant Flow|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453329|NCT00611026|P2|Participant Flow|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453330|NCT00611026|P1|Participant Flow|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453331|NCT00611026|O2|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453332|NCT00611026|O1|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453333|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453334|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453335|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453336|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453337|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453338|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453339|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453340|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453508|NCT00619151|O1|Outcome|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
453344|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453345|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453346|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453347|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453348|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453349|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453350|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453351|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453352|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453353|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453354|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453355|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453356|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453357|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453358|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453359|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453360|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453361|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453362|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453363|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453364|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453365|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453366|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453367|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453368|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453369|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453370|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453371|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453372|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453373|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453374|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453375|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453376|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453377|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453378|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453379|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453380|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453381|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453382|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453383|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453384|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453385|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453386|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453388|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453389|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453390|NCT00611026|E3|Reported Event|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
453391|NCT00611026|E2|Reported Event|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
453392|NCT00611026|E1|Reported Event|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
453393|NCT00611130|B3|Baseline|Total|Total of all reporting groups
453394|NCT00611130|B2|Baseline|Placebo|Matching Placebo Tablets. 3 tablets bid.
453395|NCT00611130|B1|Baseline|CPP-109 Vigabatrin|CPP-109 tablets, 500 mg. 3 Tablets bid.
453396|NCT00611130|P2|Participant Flow|Placebo|Matching Placebo Tablets. 3 tablets bid.
453397|NCT00611130|P1|Participant Flow|CPP-109 Vigabatrin|CPP-109 tablets, 500 mg. 3 Tablets bid.
453398|NCT00611130|O1|Outcome|Treatment Phase Completers|Up to 12 urine specimens out of 37 collected during the Treatment Phase completers were analyzed for vigabatrin levels.
453399|NCT00611130|O2|Outcome|Matching Placebo Tablets|Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
453400|NCT00611130|O1|Outcome|CPP-109 Vigabatrin Tablets, 500 mg|Vigabatrin Tablets, 1.5 g bid po, 12 weeks, computerized cognitive behavioral therapy plus contingency management.Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin) and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) for efficacy and safety assessments and for treatment during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
453401|NCT00611130|E2|Reported Event|Matching Placebo Tablet|Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
453402|NCT00611130|E1|Reported Event|CPP-109 Vigabatrin Tablets, 500 mg|Vigabatrin Tablets, 1.5 g bid po, 12 weeks. Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin), and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
453403|NCT00611247|B3|Baseline|Total|Total of all reporting groups
453404|NCT00611247|B2|Baseline|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
453405|NCT00611247|B1|Baseline|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
453406|NCT00611247|P2|Participant Flow|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
453407|NCT00611247|P1|Participant Flow|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
453408|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
453409|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
453410|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
453411|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
453412|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
453413|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
453414|NCT00611247|E2|Reported Event|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
453415|NCT00611247|E1|Reported Event|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
453416|NCT00618956|B3|Baseline|Total|Total of all reporting groups
453417|NCT00618956|B2|Baseline|Milnacipran|
453418|NCT00618956|B1|Baseline|Placebo|
453419|NCT00618956|P2|Participant Flow|Milnacipran|Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
453420|NCT00618956|P1|Participant Flow|Placebo|ITT N= 93, OC analyzed n=89
453421|NCT00618956|O2|Outcome|Milnacipran|ITT N=181, OC analyzed n=162
453422|NCT00618956|O1|Outcome|Placebo|ITT N=93, OC analyzed n=84
453423|NCT00618956|O2|Outcome|Milnacipran|ITT N= 181, OC analyzed n=176
453424|NCT00618956|O1|Outcome|Placebo|ITT N= 93, OC analyzed n=89
453425|NCT00618956|O2|Outcome|Milnacipran|ITT N=181, OC analyzed n=162
453426|NCT00618956|O1|Outcome|Placebo|ITT N=93, OC analyzed n=84
453427|NCT00618956|O2|Outcome|Milnacipran|Normotensive: ITT N= 93, OC analyzed n=82; hypertensive: ITT N=88, OC analyzed n=80
453428|NCT00618956|O1|Outcome|Placebo|Normotensive: ITT N= 42, OC analyzed n=37; hypertensive: ITT N=51, OC analyzed n=47
453429|NCT00618956|O2|Outcome|Milnacipran|ITT N= 181, OC analyzed n=176
453430|NCT00618956|O1|Outcome|Placebo|ITT N= 93, OC analyzed n=89
453431|NCT00618956|O2|Outcome|Milnacipran|Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
453432|NCT00618956|O1|Outcome|Placebo|Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
453433|NCT00618956|E2|Reported Event|Milnacipran|Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
453434|NCT00618956|E1|Reported Event|Placebo|ITT N= 93, OC analyzed n=89
453435|NCT00618982|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
453436|NCT00618982|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
453437|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
453438|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
453439|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
453440|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
453441|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
453442|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
453443|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
453444|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
453445|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
453446|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
453447|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
453448|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
453449|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
453450|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
453451|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
453452|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
453453|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
453454|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
453455|NCT00618982|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle,600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
453456|NCT00618995|B1|Baseline|Totals For Study|All participants in the study.
453457|NCT00618995|P4|Participant Flow|Sequence 4: A/D/B/C|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days
B = ER Niacin 2 g once daily for 7 days
C = Laropiprant 40 mg once daily for 7 days
D = Placebo once daily for 7 days"
453458|NCT00618995|P3|Participant Flow|Sequence 3: B/A/C/D|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days
B = ER Niacin 2 g once daily for 7 days
C = Laropiprant 40 mg once daily for 7 days
D = Placebo once daily for 7 days"
453459|NCT00618995|P2|Participant Flow|Sequence 2: C/B/D/A|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days
B = ER Niacin 2 g once daily for 7 days
C = Laropiprant 40 mg once daily for 7 days
D = Placebo once daily for 7 days"
453460|NCT00618995|P1|Participant Flow|Sequence 1: D/C/A/B|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days
B = ER Niacin 2 g once daily for 7 days
C = Laropiprant 40 mg once daily for 7 days
D = Placebo once daily for 7 days"
453461|NCT00618995|O4|Outcome|Placebo|Placebo once daily for 7 days
453462|NCT00618995|O3|Outcome|Laropiprant|Laropiprant 40 mg once daily for 7 days
453463|NCT00618995|O2|Outcome|ER Niacin|ER Niacin 2 g once daily for 7 days
453464|NCT00618995|O1|Outcome|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
453465|NCT00618995|O4|Outcome|Placebo|Placebo once daily for 7 days
453466|NCT00618995|O3|Outcome|Laropiprant|Laropiprant 40 mg once daily for 7 days
453467|NCT00618995|O2|Outcome|ER Niacin|ER Niacin 2 g once daily for 7 days
453468|NCT00618995|O1|Outcome|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
453469|NCT00618995|E4|Reported Event|Placebo|Placebo once daily for 7 days
453470|NCT00618995|E3|Reported Event|Laropiprant|Laropiprant 40 mg once daily for 7 days
453471|NCT00618995|E2|Reported Event|ER Niacin|ER Niacin 2 g once daily for 7 days
453509|NCT00619151|O2|Outcome|St.Jude Valve|St. Jude Medical Regent Valve
453472|NCT00618995|E1|Reported Event|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
453473|NCT00619060|B1|Baseline|Myristyl, Placebo|"Participants apply topical myristyl nicotinate to the and topical placebo to the other forearm once daily for 4 weeks; Myristyl, Placebo
Topical Myristyl Nicotinate Cream and Placebo : Applied topically"
453474|NCT00619060|P2|Participant Flow|Myristyl (Left), Placebo (Right)|Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo
453475|NCT00619060|P1|Participant Flow|Myristyl (Right), Placebo (Left)|"Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left)Topical Myristyl Nicotinate Cream and Placebo
Topical Myristyl Nicotinate Cream and Placebo : Applied topically"
453476|NCT00619060|O2|Outcome|Topical Placebo Cream|Participants apply topical placebo cream to one forearm.
453477|NCT00619060|O1|Outcome|Myristyl Nicotinate Cream|Participants apply topical myristyl nicotinate to one forearm.
453478|NCT00619060|E4|Reported Event|Other Non-Derm Events|Systemic Other Adverse Events, i.e. Common Cold, Migraine
453479|NCT00619060|E3|Reported Event|Myristyl Forearm (Only)|Forearms receiving the Myristyl
453480|NCT00619060|E2|Reported Event|Placebo Forearm (Only)|Forearms receiving the Placebo
453481|NCT00619060|E1|Reported Event|Both Forearms|Forearms receiving the Myristyl and Placebo, both arms affected
453482|NCT00619073|B1|Baseline|Entire Study Population|Includes groups randomized to receive clopidogrel + aspirin first and placebo + aspirin first
453483|NCT00619073|P2|Participant Flow|Placebo Then Clopidogrel|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. clopidogrel) will then be discontinued and aspirin continued for another 45 days.
453484|NCT00619073|P1|Participant Flow|Clopidogrel Then Placebo|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. placebo) will then be discontinued and aspirin continued for another 45 days.
453485|NCT00619073|O2|Outcome|Placebo + Aspirin|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.
453486|NCT00619073|O1|Outcome|Clopidogrel + Aspirin|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days.
453487|NCT00619073|E2|Reported Event|Placebo + Aspirin|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.
453488|NCT00619073|E1|Reported Event|Clopidogrel + Aspirin|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days.
453489|NCT00619099|B3|Baseline|Total|Total of all reporting groups
453490|NCT00619099|B2|Baseline|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
453491|NCT00619099|B1|Baseline|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
453492|NCT00619099|P2|Participant Flow|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
453493|NCT00619099|P1|Participant Flow|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
453494|NCT00619099|O2|Outcome|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
453495|NCT00619099|O1|Outcome|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
453496|NCT00619099|E2|Reported Event|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
453497|NCT00619099|E1|Reported Event|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
453498|NCT00619112|B1|Baseline|Temozolomide|"single arm trial
temozolomide : single arm study"
453499|NCT00619112|P1|Participant Flow|Temozolomide|"single arm trial
temozolomide : single arm study"
453500|NCT00619112|O1|Outcome|Temozolomide|"single arm trial
temozolomide : single arm study"
453501|NCT00619112|E1|Reported Event|Temozolomide|"single arm trial
temozolomide : single arm study"
453502|NCT00619151|B3|Baseline|Total|Total of all reporting groups
453503|NCT00619151|B2|Baseline|St.Jude Valve|St. Jude Medical Regent Valve
453504|NCT00619151|B1|Baseline|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
453505|NCT00619151|P2|Participant Flow|St.Jude Valve|St. Jude Medical Regent Valve
453506|NCT00619151|P1|Participant Flow|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
453513|NCT00619177|B1|Baseline|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
453514|NCT00619177|P1|Participant Flow|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
453515|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
453516|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
453517|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
453518|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
453519|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
453520|NCT00619177|E1|Reported Event|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
453521|NCT00619190|B3|Baseline|Total|Total of all reporting groups
453522|NCT00619190|B2|Baseline|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
453523|NCT00619190|B1|Baseline|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
453524|NCT00619190|P2|Participant Flow|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.
453525|NCT00619190|P1|Participant Flow|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
453526|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
453527|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
453528|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
453529|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
453530|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
453531|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
453532|NCT00619190|E2|Reported Event|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
453533|NCT00619190|E1|Reported Event|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
453534|NCT00619229|B3|Baseline|Total|Total of all reporting groups
453535|NCT00619229|B2|Baseline|Placebo|Placebo i.v. for 15 days
453536|NCT00619229|B1|Baseline|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453537|NCT00619229|P2|Participant Flow|Placebo|Placebo i.v. for 15 days
453538|NCT00619229|P1|Participant Flow|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453539|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
453540|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453541|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
453542|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453543|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
453544|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453545|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
453546|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453547|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
453548|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453549|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
453550|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453551|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
453552|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453553|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
453554|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453555|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
453556|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453557|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
453558|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453559|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
453560|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453561|NCT00619229|E2|Reported Event|Placebo|Placebo i.v. for 15 days
453562|NCT00619229|E1|Reported Event|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
453563|NCT00619242|B1|Baseline|Sorafenib|
453564|NCT00619242|P1|Participant Flow|Sorafenib|Sorafenib 400mg BID
453565|NCT00619242|O1|Outcome|Sorafenib|
453566|NCT00619242|E1|Reported Event|Sorafenib|
453567|NCT00619762|B1|Baseline|LTN - Porcine Acellulare Dermal Matrix in Breast Recon|This was a single arm sudy without a control arm LTM used to reinforce weak tissue in breast reconstruction surgery
453568|NCT00619762|P1|Participant Flow|LTM - Porcine Acellular Dermal Matrix in Breast Reconstruct|"This was a single arm sudy without a control arm
Use of LTM to reinforce weak tissue in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction."
453569|NCT00619762|O1|Outcome|Treatment Arm|All implanted patients in the study, that is 29 breasts in 17 patients
453571|NCT00619762|E1|Reported Event|Treatment Arm|All implanted patients in the study, that is 29 breasts in 17 patients
453572|NCT00619801|B3|Baseline|Total|Total of all reporting groups
453573|NCT00619801|B2|Baseline|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453574|NCT00619801|B1|Baseline|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453575|NCT00619801|P2|Participant Flow|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453576|NCT00619801|P1|Participant Flow|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453577|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453578|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453579|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453580|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453581|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453582|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453583|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453584|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453585|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453586|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453587|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453588|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453589|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453590|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453591|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453592|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453593|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453627|NCT00619918|B1|Baseline|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:
In ED: every 20 minutes up to 3 doses
In Inpatient: every 8 hours until discharge"
453594|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453595|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453596|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453597|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453598|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453599|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453600|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453601|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453602|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453603|NCT00619801|E2|Reported Event|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453604|NCT00619801|E1|Reported Event|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
453605|NCT00619827|B3|Baseline|Total|Total of all reporting groups
453606|NCT00619827|B2|Baseline|Placebo|Placebo tablet
453607|NCT00619827|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
453608|NCT00619827|P2|Participant Flow|Placebo|Placebo tablet
453609|NCT00619827|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
453610|NCT00619827|O2|Outcome|Placebo|Placebo tablet
453611|NCT00619827|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
453612|NCT00619827|E2|Reported Event|Placebo|Placebo tablet
453613|NCT00619827|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
453614|NCT00619892|B3|Baseline|Total|Total of all reporting groups
453615|NCT00619892|B2|Baseline|Placebo|Placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
453616|NCT00619892|B1|Baseline|Quetiapine|Quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
453617|NCT00619892|P2|Participant Flow|Placebo|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
453618|NCT00619892|P1|Participant Flow|Quetiapine SR|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
453619|NCT00619892|O2|Outcome|Placebo|"Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations).
placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication."
453620|NCT00619892|O1|Outcome|Quetiapine XR|"Our target daily dose for quetiapine XR was 200 mg/day. The detailed quetiapine XR dosing guidelines were as follows: 50 mg 1 tab po at HS × 3 days, then, if 50 mg tolerated, increase to 50 mg 2 tabs at HS × 4 days; at the beginning of week 2, if the last dose was tolerated increase to 50 mg 3 tabs at HS × 3 days, then, if 150 mg tolerated, increase to 4 tabs at HS; at the beginning of week 3, if no efficacy & the 200 mg dose was well tolerated, increase to one 300 mg tab at HS-otherwise remain at 200 mg one tab at HS; at week 4 if still no improvement, & 300 mg was tolerable, increase to 200 mg tablet 2 at HS. From the beginning of week 5 to the end of the trial, quetiapine XR doses were held. We used quetiapine XR tablets provided by Astra Zeneca (50, 200, and 300 mg designations).
quetiapine XR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg."
453621|NCT00619892|O2|Outcome|Placebo|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
453622|NCT00619892|O1|Outcome|Quetiapine SR|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
453623|NCT00619892|E2|Reported Event|Placebo Group|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
453624|NCT00619892|E1|Reported Event|Quietapine Group|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
453625|NCT00619918|B3|Baseline|Total|Total of all reporting groups
453626|NCT00619918|B2|Baseline|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:
In ED: every 20 minutes up to 3 doses
In Inpatient: every 8 hours until discharge"
453628|NCT00619918|P2|Participant Flow|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:
In ED: every 20 minutes up to 3 doses
In Inpatient: every 8 hours until discharge"
453729|NCT00619970|O2|Outcome|Children Receiving Rifaximin|2/3 Patients with CAP
453629|NCT00619918|P1|Participant Flow|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:
In ED: every 20 minutes up to 3 doses
In Inpatient: every 8 hours until discharge"
453630|NCT00619918|O2|Outcome|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:
In ED: every 20 minutes up to 3 doses
In Inpatient: every 8 hours until discharge"
453631|NCT00619918|O1|Outcome|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:
In ED: every 20 minutes up to 3 doses
In Inpatient: every 8 hours until discharge"
453632|NCT00619918|O2|Outcome|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:
In ED: every 20 minutes up to 3 doses
In Inpatient: every 8 hours until discharge"
453633|NCT00619918|O1|Outcome|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:
In ED: every 20 minutes up to 3 doses
In Inpatient: every 8 hours until discharge"
453634|NCT00619918|E2|Reported Event|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:
In ED: every 20 minutes up to 3 doses
In Inpatient: every 8 hours until discharge"
453635|NCT00619918|E1|Reported Event|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:
In ED: every 20 minutes up to 3 doses
In Inpatient: every 8 hours until discharge"
453636|NCT00619957|B3|Baseline|Total|Total of all reporting groups
453637|NCT00619957|B2|Baseline|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453638|NCT00619957|B1|Baseline|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453639|NCT00619957|P2|Participant Flow|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453640|NCT00619957|P1|Participant Flow|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453641|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453642|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453643|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453644|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453645|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453646|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453647|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453648|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453649|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453650|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453651|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453652|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453653|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453654|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453655|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453656|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453657|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453658|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453659|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453660|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453661|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453662|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453663|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453664|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453665|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453666|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453667|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453668|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453669|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453670|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453671|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
456434|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
453672|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453673|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453674|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453675|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453676|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453677|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453678|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453679|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453680|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453681|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453682|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453683|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453684|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453685|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453686|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453687|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453688|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453689|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453690|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453691|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453692|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453693|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453694|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453695|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453696|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453697|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453698|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453699|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453700|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453701|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453702|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453703|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453704|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453705|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453706|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453707|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453708|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453709|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453710|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453711|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453712|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453713|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
453714|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
453715|NCT00619957|E4|Reported Event|Risedronate Year 4|Risedronate 35 mg tablet once weekly Years 1 thru 4
453716|NCT00619957|E3|Reported Event|Placebo-Risedronate Year 4|Placebo once weekly Years 1 & 2 followed by risedronate 35 mg once weekly Years 3 & 4
456435|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
453726|NCT00619970|O2|Outcome|Children Receiving Placebo|1/3 patients with CAP
453731|NCT00619970|E3|Reported Event|Children Receiving Placebo|1/3 patients with CAP
453732|NCT00619970|E2|Reported Event|Children Receiving Rifaximin|2/3 Patients with CAP
453733|NCT00619970|E1|Reported Event|Healthy Control|Healthy controls
453734|NCT00619983|B5|Baseline|Total|Total of all reporting groups
453735|NCT00619983|B4|Baseline|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453736|NCT00619983|B3|Baseline|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453737|NCT00619983|B2|Baseline|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453738|NCT00619983|B1|Baseline|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453739|NCT00619983|P4|Participant Flow|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453740|NCT00619983|P3|Participant Flow|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453741|NCT00619983|P2|Participant Flow|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453742|NCT00619983|P1|Participant Flow|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453743|NCT00619983|O4|Outcome|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453744|NCT00619983|O3|Outcome|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453745|NCT00619983|O2|Outcome|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453746|NCT00619983|O1|Outcome|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453747|NCT00619983|E4|Reported Event|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453748|NCT00619983|E3|Reported Event|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453749|NCT00619983|E2|Reported Event|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453750|NCT00619983|E1|Reported Event|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
453751|NCT00620022|B1|Baseline|Entire Study Population|The entire study population includes the group of patients who received indacaterol 300 μg in the first treatment period followed by placebo in the second treatment period and the group of patients who received placebo in the first treatment period followed by indacaterol 300 μg in the second treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
453752|NCT00620022|P2|Participant Flow|Placebo Followed by Indacaterol 300 μg|Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
453753|NCT00620022|P1|Participant Flow|Indacaterol 300 μg Followed by Placebo|Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
453754|NCT00620022|O2|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
453755|NCT00620022|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
453756|NCT00620022|O2|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
453757|NCT00620022|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
453758|NCT00620022|E2|Reported Event|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
453856|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
454623|NCT00621855|B2|Baseline|75mg Dabigatran Etexilate|26 week blinded treatment
453759|NCT00620022|E1|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
454174|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
453760|NCT00620035|B1|Baseline|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
453761|NCT00620035|P1|Participant Flow|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
453762|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
453763|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
453764|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
453765|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
453766|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
453767|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
453768|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
453769|NCT00620035|E1|Reported Event|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
453859|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453860|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453770|NCT00620074|B1|Baseline|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).
Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.
Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
453771|NCT00620074|P1|Participant Flow|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).
Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.
Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
453772|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
453773|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
453774|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
453775|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
453776|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
453777|NCT00620074|E1|Reported Event|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).
Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.
Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
453778|NCT00620113|B5|Baseline|Total|Total of all reporting groups
453779|NCT00620113|B4|Baseline|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453780|NCT00620113|B3|Baseline|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453781|NCT00620113|B2|Baseline|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453782|NCT00620113|B1|Baseline|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453783|NCT00620113|P4|Participant Flow|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453784|NCT00620113|P3|Participant Flow|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453785|NCT00620113|P2|Participant Flow|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453786|NCT00620113|P1|Participant Flow|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453787|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453788|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453789|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453790|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453791|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453792|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453793|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453794|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453795|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453796|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453797|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453798|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453799|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453800|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453801|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453802|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453803|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453804|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453805|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453806|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453857|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453858|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453807|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453808|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453809|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453810|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453811|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453812|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453813|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453814|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453815|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453816|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453817|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453818|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453819|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453820|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453821|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453822|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453823|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453824|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453825|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453826|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453827|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453828|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453829|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453830|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453831|NCT00620113|E4|Reported Event|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453832|NCT00620113|E3|Reported Event|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453833|NCT00620113|E2|Reported Event|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453834|NCT00620113|E1|Reported Event|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
453835|NCT00620126|B3|Baseline|Total|Total of all reporting groups
453836|NCT00620126|B2|Baseline|Control|Best Available Care
453837|NCT00620126|B1|Baseline|Intervention|UC Home Automated Telemanagement
453838|NCT00620126|P2|Participant Flow|Best Available Care|The standard of care for participants in this study is modeled after the standard of care at our institution, and based on current evidence-based guidelines including comprehensive assessment, a guideline-concordant therapy plan, scheduled and as needed clinic visits, scheduled and as needed telephone calls, and administration of educational fact sheets about disease-specific topics when appropriate. We expanded the care received by controls to make the groups more comparable. First, we provided the control group with all currently available educational fact sheets from the Crohn’s and Colitis Foundation at the time of group allocation. Second, we provided the control group with individualized written action plans at the time of group assignment without reinforcement.
453839|NCT00620126|P1|Participant Flow|UC Home Automated Telemanagement|The UC HAT home unit consists of a netbook computer and an electronic weight scale. Participants answer questions regarding symptoms, side effects, adherence, and receive disease-specific education using the home unit. The home unit automatically transmits the results to the decision support server after each self-testing session. Participants completed self-testing weekly. Updated action plans are automatically transmitted to participant home units if certain criteria are met. If certain clinical conditions are met, email alerts are sent to the nurse coordinator. The coordinator reviews the information and if necessary consults the medical provider and the participant for management changes.
453840|NCT00620126|O2|Outcome|Control|Best Available Care
453841|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
453842|NCT00620126|O2|Outcome|Control|Best Available Care
453843|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
453844|NCT00620126|O2|Outcome|Control|Best Available Care
453845|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
453846|NCT00620126|E2|Reported Event|Control|Best Available Care
453847|NCT00620126|E1|Reported Event|Intervention|UC Home Automated Telemanagement
453848|NCT00620282|B4|Baseline|Total|Total of all reporting groups
453849|NCT00620282|B3|Baseline|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453850|NCT00620282|B2|Baseline|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453851|NCT00620282|B1|Baseline|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453852|NCT00620282|P3|Participant Flow|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453853|NCT00620282|P2|Participant Flow|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453854|NCT00620282|P1|Participant Flow|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453855|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453903|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
453861|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453862|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453863|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453864|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453865|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453866|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453867|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453868|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453869|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453870|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453871|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453872|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453873|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453874|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453875|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453876|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453877|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453878|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453879|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453880|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453881|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453882|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453883|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453884|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453885|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453886|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453887|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453888|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453889|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453890|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453891|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453892|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453893|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453894|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453895|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453896|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453897|NCT00620282|E3|Reported Event|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
453898|NCT00620282|E2|Reported Event|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453899|NCT00620282|E1|Reported Event|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
453900|NCT00620373|B1|Baseline|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-mBQ (20-mCi) Technetium (99mTc) sestamibi injection.
453901|NCT00620373|P1|Participant Flow|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
453902|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
456436|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
453904|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
453905|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
453906|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
453907|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
453908|NCT00620373|O1|Outcome|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-mBQ (20-mCi) Technetium (99mTc) sestamibi injection.
453909|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
453910|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
453911|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
453912|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
453913|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
453914|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
453915|NCT00620373|E1|Reported Event|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
453916|NCT00620425|B1|Baseline|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
453917|NCT00620425|P1|Participant Flow|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
453918|NCT00620425|O8|Outcome|72 hr Post-dose|Only 3 subjects were required to return on Day 4. Day 4 assessments included a 72 hour assessment for the first and second injections and a 48 hour assessment for the third injection.
453919|NCT00620425|O7|Outcome|48 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
453920|NCT00620425|O6|Outcome|24 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
453921|NCT00620425|O5|Outcome|8 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
453922|NCT00620425|O4|Outcome|4 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
453923|NCT00620425|O3|Outcome|1 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
453924|NCT00620425|O2|Outcome|All Participants Immediately Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
453925|NCT00620425|O1|Outcome|All Participants at -15 Min Pre-dose|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
453926|NCT00620425|E1|Reported Event|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
453927|NCT00620464|B3|Baseline|Total|Total of all reporting groups
453928|NCT00620464|B2|Baseline|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.
The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
453929|NCT00620464|B1|Baseline|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
453930|NCT00620464|P2|Participant Flow|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.
The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
453931|NCT00620464|P1|Participant Flow|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
453932|NCT00620464|O2|Outcome|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.
The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
453933|NCT00620464|O1|Outcome|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
453934|NCT00620464|O2|Outcome|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.
The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
453935|NCT00620464|O1|Outcome|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
453936|NCT00620464|E2|Reported Event|Radiopaque Implanon|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
453996|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
454126|NCT00620854|B5|Baseline|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
453937|NCT00620464|E1|Reported Event|Implanon|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.
The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
453938|NCT00620542|B3|Baseline|Total|Total of all reporting groups
453939|NCT00620542|B2|Baseline|Atorvastatin 80 mg|2 years
453940|NCT00620542|B1|Baseline|Rosuvastatin 40 mg|2 years
453941|NCT00620542|P4|Participant Flow|Atorvastatin 80 mg|2 year core study
453942|NCT00620542|P3|Participant Flow|Rosuvastatin 40 mg|2 year core study
453943|NCT00620542|P2|Participant Flow|Atorvastatin 40 mg|2 week run-in period
453944|NCT00620542|P1|Participant Flow|Rosuvastatin 20 mg|2 week run-in period
453945|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453946|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453947|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453948|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453949|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453950|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453951|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453952|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453953|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453954|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453955|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453956|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453957|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453958|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453959|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453960|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453961|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453962|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453963|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453964|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453965|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453966|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453967|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453968|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453969|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453970|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453971|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453972|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453973|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453974|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453975|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
453976|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
453977|NCT00620542|E4|Reported Event|Atorvastatin 80 mg|2 year core study
453978|NCT00620542|E3|Reported Event|Rosuvastatin 40 mg|2 year core study
453979|NCT00620542|E2|Reported Event|Atorvastatin 40 mg|2 week run-in period
453980|NCT00620542|E1|Reported Event|Rosuvastatin 20 mg|2 week run-in period
453981|NCT00620555|B1|Baseline|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
453982|NCT00620555|P1|Participant Flow|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
453983|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
453984|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
453985|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
453986|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
453987|NCT00620555|E1|Reported Event|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
453988|NCT00620659|B1|Baseline|All Randomized Participants|All participants randomized in study
453989|NCT00620659|P6|Participant Flow|Modafinil/Placebo/MK0249|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
453990|NCT00620659|P5|Participant Flow|Placebo/MK0249/Modafinil|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
453991|NCT00620659|P4|Participant Flow|MK0249/Modafinil/Placebo|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
453992|NCT00620659|P3|Participant Flow|Modafinil/MK0249/Placebo|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
453993|NCT00620659|P2|Participant Flow|Placebo/Modafinil/MK0249|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
453994|NCT00620659|P1|Participant Flow|MK0249/Placebo/Modafinil|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
453995|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
456437|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
453997|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
453998|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
453999|NCT00620659|O2|Outcome|Modafinil 200 mg|There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).
454000|NCT00620659|O1|Outcome|MK0249 Top 2 Doses Pooled|"The top 2 doses (the two doses to which most patients were adaptively assigned) were 10 mg and 12 mg.
There were 74 participants who received MK0249 10 and 12 mg over 3 periods (25, 22, and 27 participants for Periods 1, 2, and 3 respectively)."
454001|NCT00620659|O2|Outcome|Modafinil 200 mg|There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).
454002|NCT00620659|O1|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
454003|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
454004|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
454005|NCT00620659|E6|Reported Event|Modafinil|Modafinil was provided as 100 mg tablets.
454006|NCT00620659|E5|Reported Event|MK0249 12 mg|MK0249 was provided as 1 mg and 5 mg tablets.
454007|NCT00620659|E4|Reported Event|MK0249 10 mg|MK0249 was provided as 1 mg and 5 mg tablets.
454008|NCT00620659|E3|Reported Event|MK0249 8 mg|MK0249 was provided as 1 mg and 5 mg tablets.
454009|NCT00620659|E2|Reported Event|MK0249 5 mg|MK0249 was provided as 1 mg and 5 mg tablets.
454010|NCT00620659|E1|Reported Event|Placebo|Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
454011|NCT00620698|B1|Baseline|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
454012|NCT00620698|P1|Participant Flow|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
454013|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
454014|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
454015|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
454016|NCT00620698|E1|Reported Event|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
454017|NCT00620711|B1|Baseline|Preter Infnats With HIE|"Babies that meet criteria will be offered participation in feasibility trial, there are no other arms. Criteria include Sentinel evnet , Low Apgar, pH less than 7, Neonatal encephalopathy with no other cause and need for mechanical ventialtion
Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE."
454018|NCT00620711|P1|Participant Flow|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
454019|NCT00620711|O1|Outcome|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
454020|NCT00620711|O1|Outcome|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
454021|NCT00620711|E1|Reported Event|Preterm Infants With HIE|"Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE."
454022|NCT00620750|B1|Baseline|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
454023|NCT00620750|P1|Participant Flow|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
454024|NCT00620750|O1|Outcome|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
454062|NCT00620776|E2|Reported Event|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454063|NCT00620776|E1|Reported Event|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454064|NCT00620815|B4|Baseline|Total|Total of all reporting groups
454624|NCT00621855|B1|Baseline|50mg Dabigatran Etexilate|26 week blinded treatment
454125|NCT00620854|B6|Baseline|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454025|NCT00620750|E1|Reported Event|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
454026|NCT00620763|B1|Baseline|Entire Study Population|Dietary Intervention: Crossover design, High meat and high potential renal acid load (high PRAL) diet and low meat and low potential renal acid load (low PRAL) diet, consumed in random order.
454027|NCT00620763|P2|Participant Flow|Low Meat & Low Potential Renal Acid Load - First|Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
454028|NCT00620763|P1|Participant Flow|High Meat & High Potential Renal Acid Load - First|High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
454029|NCT00620763|O2|Outcome|Low Meat - Low Potential Renal Acid Load|Low meat and low potential renal acid load (low PRAL) diet in either the first or second intervention period
454030|NCT00620763|O1|Outcome|High Meat - High Potential Renal Acid Load|High meat and high potential renal acid load (high PRAL) diet in either the first or second intervention period
454031|NCT00620763|E2|Reported Event|Low Meat & Low Potential Renal Acid Load - First|Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
454032|NCT00620763|E1|Reported Event|High Meat & High Potential Renal Acid Load - First|High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
454033|NCT00620776|B3|Baseline|Total|Total of all reporting groups
454034|NCT00620776|B2|Baseline|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454035|NCT00620776|B1|Baseline|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454036|NCT00620776|P2|Participant Flow|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454037|NCT00620776|P1|Participant Flow|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454038|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454039|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454040|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454041|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454042|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454043|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454044|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454045|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454046|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454047|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454048|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454049|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454050|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454051|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454052|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454053|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454054|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454055|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454056|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454057|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454058|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454059|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454060|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
454061|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
454065|NCT00620815|B3|Baseline|A/S-A|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
454066|NCT00620815|B2|Baseline|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
454067|NCT00620815|B1|Baseline|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
454068|NCT00620815|P3|Participant Flow|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
454069|NCT00620815|P2|Participant Flow|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
454070|NCT00620815|P1|Participant Flow|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
454071|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
454072|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
454073|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
454074|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
454075|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
454076|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
454077|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
454078|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
454079|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
454080|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
454081|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
454082|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
454083|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
454084|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
454085|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
454086|NCT00620815|O6|Outcome|A/S-A: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed 3 to 5 weeks later by Aflunov (A)
454087|NCT00620815|O5|Outcome|A/P-T: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by tetravalent influenza vaccine (T)
454088|NCT00620815|O4|Outcome|T/P-A: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by Aflunov (A)
454089|NCT00620815|O3|Outcome|A/S-A: After 1st Vaccination|Systemic reactions after first vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed 3 to 5 weeks later by Aflunov (A)
454090|NCT00620815|O2|Outcome|A/P-T: After 1st Vaccination|Systemic reactions after first vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by tetravalent influenza vaccine (T)
454091|NCT00620815|O1|Outcome|T/P-A: After 1st Vaccination|Systemic reactions after first vaccination after one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by Aflunov (A)
454092|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
454124|NCT00620854|B7|Baseline|Total|Total of all reporting groups
454093|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
454094|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
454095|NCT00620815|O6|Outcome|A/S-A: In Arm Receiving Seasonal Influenza Vaccine (S)|Local reactions after first vaccination in arm receiving seasonal influenza vaccination in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22
454096|NCT00620815|O5|Outcome|A/S-A: In Arm Receiving Aflunov (A)|Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) bon day 22
454097|NCT00620815|O4|Outcome|A/P-T: In Arm Receiving Placebo (P)|Local reactions after first vaccination in arm receiving Placebo in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22
454098|NCT00620815|O3|Outcome|A/P-T: In Arm Receiving Aflunov (A)|Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine(T) on day 22
454099|NCT00620815|O2|Outcome|T/P-A: In Arm Receiving Placebo (P)|Local reactions after first vaccination in arm receiving placebo in group receiving one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
454100|NCT00620815|O1|Outcome|T/P-A: In Arm Receiving Tetravalent Vaccine (T)|Local reactions after first vaccination in arm receiving tetravalent influenza vaccine in group receiving one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
454101|NCT00620815|O3|Outcome|A/S-A|One dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22
454102|NCT00620815|O2|Outcome|A/P-T|One dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22
454103|NCT00620815|O1|Outcome|T/P-A|One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
454104|NCT00620815|E3|Reported Event|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
454105|NCT00620815|E2|Reported Event|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
454106|NCT00620815|E1|Reported Event|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
454107|NCT00620828|B3|Baseline|Total|Total of all reporting groups
454108|NCT00620828|B2|Baseline|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
454109|NCT00620828|B1|Baseline|Control Group|Subjects receive intra-op saline injection per protocol
454110|NCT00620828|P2|Participant Flow|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
454111|NCT00620828|P1|Participant Flow|Control Group|Subjects receive intra-op saline injection per protocol
454112|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
454113|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
454114|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
454115|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
454116|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
454117|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
454118|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
454119|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
454120|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
454121|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
454122|NCT00620828|E2|Reported Event|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
454123|NCT00620828|E1|Reported Event|Control Group|Subjects receive intra-op saline injection per protocol
454127|NCT00620854|B4|Baseline|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454128|NCT00620854|B3|Baseline|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454129|NCT00620854|B2|Baseline|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454130|NCT00620854|B1|Baseline|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454131|NCT00620854|P6|Participant Flow|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454132|NCT00620854|P5|Participant Flow|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454133|NCT00620854|P4|Participant Flow|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454134|NCT00620854|P3|Participant Flow|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454135|NCT00620854|P2|Participant Flow|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454136|NCT00620854|P1|Participant Flow|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454137|NCT00620854|O3|Outcome|Fortical®|Fortical nasal spray (200 IU)
454138|NCT00620854|O2|Outcome|rsCTB|Oral rsCT (200 micrograms)
454139|NCT00620854|O1|Outcome|rsCT A|Oral rsCT (150 micrograms)
454140|NCT00620854|E6|Reported Event|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454141|NCT00620854|E5|Reported Event|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454142|NCT00620854|E4|Reported Event|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454143|NCT00620854|E3|Reported Event|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454144|NCT00620854|E2|Reported Event|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454145|NCT00620854|E1|Reported Event|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
454146|NCT00621023|B1|Baseline|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS
Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
454147|NCT00621023|P1|Participant Flow|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS
Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
454148|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS
Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
454149|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS
Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
454150|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS
Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
454169|NCT00621140|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
454170|NCT00621140|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454171|NCT00621140|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
454172|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454173|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454151|NCT00621023|E1|Reported Event|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS
Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
454152|NCT00621049|B3|Baseline|Total|Total of all reporting groups
454153|NCT00621049|B2|Baseline|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
454154|NCT00621049|B1|Baseline|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
454155|NCT00621049|P2|Participant Flow|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
454156|NCT00621049|P1|Participant Flow|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
454157|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
454158|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
454159|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
454160|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
454161|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
454162|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
454163|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
454164|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
454165|NCT00621049|E2|Reported Event|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
454166|NCT00621049|E1|Reported Event|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
454167|NCT00621140|B3|Baseline|Total|Total of all reporting groups
454168|NCT00621140|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454175|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454176|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454177|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454178|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454179|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454180|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454181|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454182|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454183|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454184|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454185|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454186|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454187|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454188|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454189|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454190|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454191|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454192|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454193|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454194|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454195|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454196|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454197|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454198|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454199|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
454200|NCT00621140|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
454201|NCT00621140|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
454202|NCT00621153|B3|Baseline|Total|Total of all reporting groups
454203|NCT00621153|B2|Baseline|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
454204|NCT00621153|B1|Baseline|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
454205|NCT00621153|P2|Participant Flow|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
454206|NCT00621153|P1|Participant Flow|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
454207|NCT00621153|O2|Outcome|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
454208|NCT00621153|O1|Outcome|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
454209|NCT00621153|E2|Reported Event|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
454210|NCT00621153|E1|Reported Event|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
454211|NCT00621192|B5|Baseline|Total|Total of all reporting groups
454212|NCT00621192|B4|Baseline|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
454213|NCT00621192|B3|Baseline|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
454214|NCT00621192|B2|Baseline|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
454215|NCT00621192|B1|Baseline|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
454216|NCT00621192|P4|Participant Flow|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
454217|NCT00621192|P3|Participant Flow|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
454218|NCT00621192|P2|Participant Flow|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
454219|NCT00621192|P1|Participant Flow|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
454220|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
454221|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
454222|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
454223|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
454224|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
454225|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
454226|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
454227|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
454625|NCT00621855|P5|Participant Flow|Placebo|26 week blinded treatment
454228|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
454229|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
454230|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
454231|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
454232|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
454233|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
454234|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
454235|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
454236|NCT00621192|E4|Reported Event|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
454237|NCT00621192|E3|Reported Event|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
454238|NCT00621192|E2|Reported Event|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
454239|NCT00621192|E1|Reported Event|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
454240|NCT00621244|B5|Baseline|Total|Total of all reporting groups
454241|NCT00621244|B4|Baseline|Arm 2, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
454242|NCT00621244|B3|Baseline|Arm 2, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
454243|NCT00621244|B2|Baseline|Arm 1, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
454244|NCT00621244|B1|Baseline|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
454245|NCT00621244|P4|Participant Flow|Arm 2, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
454246|NCT00621244|P3|Participant Flow|Arm 2, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
454247|NCT00621244|P2|Participant Flow|Arm 1, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
454248|NCT00621244|P1|Participant Flow|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
454249|NCT00621244|O7|Outcome|Arm 2, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
454250|NCT00621244|O6|Outcome|Arm 2, Group Y (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
454251|NCT00621244|O5|Outcome|Arm 2, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
454252|NCT00621244|O4|Outcome|Arm 2, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
454253|NCT00621244|O3|Outcome|Arm 2, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
454254|NCT00621244|O2|Outcome|Arm 2, Group X (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
454255|NCT00621244|O1|Outcome|Arm 2, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
454256|NCT00621244|O9|Outcome|Arm 1, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
454257|NCT00621244|O8|Outcome|Arm 1, Group Y (40mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
454258|NCT00621244|O7|Outcome|Arm 1, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
454259|NCT00621244|O6|Outcome|Arm 1, Group Y (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
454260|NCT00621244|O5|Outcome|Arm 1, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
454261|NCT00621244|O4|Outcome|Arm 1, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
454262|NCT00621244|O3|Outcome|Arm 1, Group X (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
454263|NCT00621244|O2|Outcome|Arm 1, Group x (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
454264|NCT00621244|O1|Outcome|Arm 1, Group X (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
454265|NCT00621244|O3|Outcome|Arm 2, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454266|NCT00621244|O2|Outcome|Arm 2, Group Y (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454267|NCT00621244|O1|Outcome|Arm 2, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454268|NCT00621244|O4|Outcome|Arm 2, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454269|NCT00621244|O3|Outcome|Arm 2, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454270|NCT00621244|O2|Outcome|Arm 2, Group X (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454271|NCT00621244|O1|Outcome|Arm 2, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454272|NCT00621244|O4|Outcome|Arm 1, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454273|NCT00621244|O3|Outcome|Arm 1, Group Y (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454274|NCT00621244|O2|Outcome|Arm 1, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454275|NCT00621244|O1|Outcome|Arm 1, Group Y (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454276|NCT00621244|O5|Outcome|Arm 1, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454277|NCT00621244|O4|Outcome|Arm 1, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454278|NCT00621244|O3|Outcome|Arm 1, Group X (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454279|NCT00621244|O2|Outcome|Arm 1, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454280|NCT00621244|O1|Outcome|Arm 1, Group X (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454281|NCT00621244|O5|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454282|NCT00621244|O4|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454283|NCT00621244|O3|Outcome|40 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454284|NCT00621244|O2|Outcome|30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454285|NCT00621244|O1|Outcome|20 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454286|NCT00621244|O5|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454287|NCT00621244|O4|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454288|NCT00621244|O3|Outcome|40 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454289|NCT00621244|O2|Outcome|30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454290|NCT00621244|O1|Outcome|20 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454291|NCT00621244|O5|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454292|NCT00621244|O4|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454293|NCT00621244|O3|Outcome|40 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454294|NCT00621244|O2|Outcome|30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454295|NCT00621244|O1|Outcome|20 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454296|NCT00621244|O6|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454297|NCT00621244|O5|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454298|NCT00621244|O4|Outcome|45 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454299|NCT00621244|O3|Outcome|40 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454300|NCT00621244|O2|Outcome|30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454301|NCT00621244|O1|Outcome|20 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454302|NCT00621244|O6|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454303|NCT00621244|O5|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454304|NCT00621244|O4|Outcome|45 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454305|NCT00621244|O3|Outcome|40 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454306|NCT00621244|O2|Outcome|30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454307|NCT00621244|O1|Outcome|20 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
454308|NCT00621244|O2|Outcome|Arm 2, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
454309|NCT00621244|O1|Outcome|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
454310|NCT00621244|O2|Outcome|Arm 2, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
454311|NCT00621244|O1|Outcome|Arm 1, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
454312|NCT00621244|O1|Outcome|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
454313|NCT00621244|O2|Outcome|Arm 2, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
454629|NCT00621855|P1|Participant Flow|50mg Dabigatran Etexilate|26 week blinded treatment
454630|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
454314|NCT00621244|O1|Outcome|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
454315|NCT00621244|O7|Outcome|Arm 2, Group Y (60 mg) - MTD|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454316|NCT00621244|O6|Outcome|Arm 2, Group Y (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454317|NCT00621244|O5|Outcome|Arm 2, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454318|NCT00621244|O4|Outcome|Arm 2, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454319|NCT00621244|O3|Outcome|Arm 2, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454320|NCT00621244|O2|Outcome|Arm 2, Group X (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454321|NCT00621244|O1|Outcome|Arm 2, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454322|NCT00621244|O9|Outcome|Arm 1, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454323|NCT00621244|O8|Outcome|Arm 1, Group Y (40 mg) - MTD|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454324|NCT00621244|O7|Outcome|Arm 1, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454325|NCT00621244|O6|Outcome|Arm 1, Group Y (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454326|NCT00621244|O5|Outcome|Arm 1, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454327|NCT00621244|O4|Outcome|Arm 1, Group X (60 mg) - MTD|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
454328|NCT00621244|O3|Outcome|Arm 1, Group X (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454329|NCT00621244|O2|Outcome|Arm 1, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454330|NCT00621244|O1|Outcome|Arm 1, Group X (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454331|NCT00621244|E16|Reported Event|Arm2 GroupY 60 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454332|NCT00621244|E15|Reported Event|Arm2 GroupY 45 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454333|NCT00621244|E14|Reported Event|Arm2 GroupY 30 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454334|NCT00621244|E13|Reported Event|Arm2 GroupX 80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454335|NCT00621244|E12|Reported Event|Arm2 GroupX 60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454336|NCT00621244|E11|Reported Event|Arm2 GroupX 45 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454337|NCT00621244|E10|Reported Event|Arm2 GroupX 30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454338|NCT00621244|E9|Reported Event|Arm1 GroupY 60 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454339|NCT00621244|E8|Reported Event|Arm1 GroupY 40 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454340|NCT00621244|E7|Reported Event|Arm1 GroupY 30 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454341|NCT00621244|E6|Reported Event|Arm1 GroupY 20 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
454342|NCT00621244|E5|Reported Event|Arm1 GroupX 80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454343|NCT00621244|E4|Reported Event|Arm1 GroupX 60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454631|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
454344|NCT00621244|E3|Reported Event|Arm1, Group X (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454345|NCT00621244|E2|Reported Event|Arm1, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454346|NCT00621244|E1|Reported Event|Arm1, Group X (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
454347|NCT00621257|B6|Baseline|Total|Total of all reporting groups
454348|NCT00621257|B5|Baseline|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years
ergocalciferol: 8000 units/ml"
454349|NCT00621257|B4|Baseline|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)
ergocalciferol: 8000 units/ml"
454350|NCT00621257|B3|Baseline|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks
ergocalciferol: 8000 units/ml"
454351|NCT00621257|B2|Baseline|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks
Cholecalciferol: 400 units per drop"
454352|NCT00621257|B1|Baseline|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)
ergocalciferol: 8000 units/ml"
454353|NCT00621257|P5|Participant Flow|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years
ergocalciferol: 8000 units/ml"
454354|NCT00621257|P4|Participant Flow|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)
ergocalciferol: 8000 units/ml"
454355|NCT00621257|P3|Participant Flow|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks
ergocalciferol: 8000 units/ml"
454356|NCT00621257|P2|Participant Flow|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks
Cholecalciferol: 400 units per drop"
454357|NCT00621257|P1|Participant Flow|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)
ergocalciferol: 8000 units/ml"
454358|NCT00621257|O2|Outcome|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years
ergocalciferol: 8000 units/ml"
454359|NCT00621257|O1|Outcome|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)
ergocalciferol: 8000 units/ml"
454360|NCT00621257|O3|Outcome|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks
ergocalciferol: 8000 units/ml"
454361|NCT00621257|O2|Outcome|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks
Cholecalciferol: 400 units per drop"
454362|NCT00621257|O1|Outcome|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)
ergocalciferol: 8000 units/ml"
454363|NCT00621257|E5|Reported Event|Maintenance B|"1,000 IU of oral vitamin D2 per day from May to October and 2,000 IU of oral vitamin D2 per day of oral vitamin D2 per day from November to April
ergocalciferol 8000 IU/ml"
454364|NCT00621257|E4|Reported Event|Maintenance A|"400 IU per day of oral vitamin D2
ergocalciferol 8000 IU/ml"
454365|NCT00621257|E3|Reported Event|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks
ergocalciferol: 8000 units/ml"
454366|NCT00621257|E2|Reported Event|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks
Cholecalciferol: 400 units per drop"
454367|NCT00621257|E1|Reported Event|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)
ergocalciferol: 8000 units/ml"
454368|NCT00621296|B1|Baseline|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
454369|NCT00621296|P1|Participant Flow|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
454370|NCT00621296|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
454371|NCT00621296|E1|Reported Event|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
454372|NCT00621322|B7|Baseline|Total|Total of all reporting groups
454373|NCT00621322|B6|Baseline|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454374|NCT00621322|B5|Baseline|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454375|NCT00621322|B4|Baseline|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454376|NCT00621322|B3|Baseline|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454377|NCT00621322|B2|Baseline|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454378|NCT00621322|B1|Baseline|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454379|NCT00621322|P6|Participant Flow|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454478|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
456438|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
454486|NCT00621504|B2|Baseline|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
454380|NCT00621322|P5|Participant Flow|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454381|NCT00621322|P4|Participant Flow|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454382|NCT00621322|P3|Participant Flow|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454383|NCT00621322|P2|Participant Flow|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454384|NCT00621322|P1|Participant Flow|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454385|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454386|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454387|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454388|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454389|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454390|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454391|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454392|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454393|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454394|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454395|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454396|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454397|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454398|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454399|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454400|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454401|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454479|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
454480|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
454402|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454403|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454404|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454405|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454406|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454407|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454408|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454409|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454410|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454411|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454412|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454413|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454414|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454415|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454416|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454417|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454418|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454419|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454420|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454421|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454422|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454423|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454481|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
454482|NCT00621348|E3|Reported Event|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
454424|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454425|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454426|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454427|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454428|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454429|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454430|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454431|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454432|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454433|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454434|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454435|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454436|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454437|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454438|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454439|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454440|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454441|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454442|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454443|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454444|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454445|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454483|NCT00621348|E2|Reported Event|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
454484|NCT00621348|E1|Reported Event|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
454446|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454447|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454448|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454449|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454450|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454451|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454452|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454453|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454454|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454455|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454456|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454457|NCT00621322|E6|Reported Event|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454458|NCT00621322|E5|Reported Event|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454459|NCT00621322|E4|Reported Event|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454460|NCT00621322|E3|Reported Event|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454461|NCT00621322|E2|Reported Event|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454462|NCT00621322|E1|Reported Event|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
454463|NCT00621348|B4|Baseline|Total|Total of all reporting groups
454464|NCT00621348|B3|Baseline|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
454465|NCT00621348|B2|Baseline|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
454466|NCT00621348|B1|Baseline|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
454467|NCT00621348|P3|Participant Flow|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
454468|NCT00621348|P2|Participant Flow|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
454469|NCT00621348|P1|Participant Flow|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
454470|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
454471|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
454472|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
454473|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
454474|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
454475|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
454476|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
454477|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
454487|NCT00621504|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
454488|NCT00621504|P2|Participant Flow|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
454489|NCT00621504|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
454490|NCT00621504|O2|Outcome|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
454491|NCT00621504|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
454492|NCT00621504|E2|Reported Event|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
454493|NCT00621504|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
454494|NCT00621517|B3|Baseline|Total|Total of all reporting groups
454495|NCT00621517|B2|Baseline|Placebo|Participants will receive matching placebo capsule nightly.
454496|NCT00621517|B1|Baseline|Bupropion|Participants will receive 150MG Bupropion nightly.
454497|NCT00621517|P2|Participant Flow|Placebo|Participants will receive matching placebo capsule nightly.
454498|NCT00621517|P1|Participant Flow|Bupropion|Participants will receive 150MG Bupropion nightly.
454499|NCT00621517|O2|Outcome|Placebo|Participants will receive matching placebo capsule nightly.
454500|NCT00621517|O1|Outcome|Bupropion|Participants will receive 150MG Bupropion nightly.
454501|NCT00621517|E2|Reported Event|Placebo|Participants will receive matching placebo capsule nightly.
454502|NCT00621517|E1|Reported Event|Bupropion|Participants will receive 150MG Bupropion nightly.
454503|NCT00621530|B3|Baseline|Total|Total of all reporting groups
454504|NCT00621530|B2|Baseline|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery
placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
454505|NCT00621530|B1|Baseline|Ketorolac|"ketorolac 2 mg
ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
454506|NCT00621530|P2|Participant Flow|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery
placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
454507|NCT00621530|P1|Participant Flow|Ketorolac|"ketorolac 2 mg
ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
454508|NCT00621530|O2|Outcome|Placebo|sterile saline placebo added to the patient's routine spinal anesthetic for surgery
454509|NCT00621530|O1|Outcome|Ketorolac|ketorolac tromethamine opthalmic solution 2 mg added to the patient's routine spinal anesthetic for surgery
454510|NCT00621530|O2|Outcome|Placebo|sterile saline placebo added to the patient's routine spinal anesthetic for surgery
454511|NCT00621530|O1|Outcome|Ketorolac|ketorolac tromethamine opthalmic solution, 2 mg added to the patient's routine spinal anesthetic for surgery
454512|NCT00621530|O2|Outcome|Placebo|sterile saline placebo added to the patient's routine spinal anesthetic for surgery
454513|NCT00621530|O1|Outcome|Ketorolac|ketorolac tromethamine opthalmic solution, 2 mg added to the patient's routine spinal anesthetic for surgery
454514|NCT00621530|O2|Outcome|Placebo|sterile saline placebo added to the patient's routine spinal anesthetic for surgery
454515|NCT00621530|O1|Outcome|Ketorolac|ketorolac tromethamine opthalmic solution, 2 mg added to the patient's routine spinal anesthetic for surgery
454516|NCT00621530|O2|Outcome|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery
placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
454517|NCT00621530|O1|Outcome|Ketorolac|"ketorolac 2 mg
ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
454518|NCT00621530|E2|Reported Event|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery
placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
454519|NCT00621530|E1|Reported Event|Ketorolac|"ketorolac 2 mg
ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
454520|NCT00621543|B1|Baseline|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
454521|NCT00621543|P1|Participant Flow|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
454522|NCT00621543|O1|Outcome|Single Arm Study|
454523|NCT00621543|O1|Outcome|Single Arm Study|
454524|NCT00621543|E1|Reported Event|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
454525|NCT00621582|B1|Baseline|Tiotropium Bromide|
454526|NCT00621582|P1|Participant Flow|Tiotropium Bromide|
454527|NCT00621582|O1|Outcome|Tiotropium Bromide|
454528|NCT00621582|O1|Outcome|Tiotropium Bromide|
454529|NCT00621582|O1|Outcome|Tiotropium Bromide|
454530|NCT00621582|O1|Outcome|Tiotropium Bromide|
454531|NCT00621582|E1|Reported Event|Tiotropium Bromide|
454532|NCT00621621|B4|Baseline|Total|Total of all reporting groups
454533|NCT00621621|B3|Baseline|Subjects Collected From Published Data|Published evidence about the safety and efficacy of using Medtronic’s Freezor® 4 mm CryoCatheter has been reported since the initiation of the CryoFACTS-PAS. The results reported in the literature provide the supplemental data in the same study population as in the PAS and are included to meet the study objectives, as agreed upon with the FDA.
454534|NCT00621621|B2|Baseline|Subjects Consented in the Study Not Ablated|Actual Subjects that were consented in the study that did not meet inclusion criteria.
454626|NCT00621855|P4|Participant Flow|150mg Dabigatran Etexilate|26 week blinded treatment
454568|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454535|NCT00621621|B1|Baseline|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.
Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
454536|NCT00621621|P2|Participant Flow|External Data Supporting the Study|Data from published reports that include subjects that met inclusion criteria for study and contained data of Heart block.
454537|NCT00621621|P1|Participant Flow|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.
Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
454538|NCT00621621|O2|Outcome|External Data Supporting the Study|This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.
454539|NCT00621621|O1|Outcome|Experimental: Freezor Catheter for AVNRT|Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmiacryoablation
454540|NCT00621621|O2|Outcome|External Data Supporting the Study|
454541|NCT00621621|O1|Outcome|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.
Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
454542|NCT00621621|E2|Reported Event|External Data Supporting the Study|"Subjects from publication search with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.
Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
454543|NCT00621621|E1|Reported Event|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.
Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
454544|NCT00621686|B3|Baseline|Total|Total of all reporting groups
454545|NCT00621686|B2|Baseline|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454546|NCT00621686|B1|Baseline|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454547|NCT00621686|P2|Participant Flow|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454548|NCT00621686|P1|Participant Flow|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454549|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454550|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454551|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454552|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454553|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454554|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454555|NCT00621686|E2|Reported Event|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454556|NCT00621686|E1|Reported Event|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
454557|NCT00621764|B5|Baseline|Total|Total of all reporting groups
454558|NCT00621764|B4|Baseline|Hepatitis A/JE CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
454559|NCT00621764|B3|Baseline|JE CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454560|NCT00621764|B2|Baseline|Hepatitis A/JE CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
454561|NCT00621764|B1|Baseline|JE CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454562|NCT00621764|P4|Participant Flow|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454563|NCT00621764|P3|Participant Flow|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454564|NCT00621764|P2|Participant Flow|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454565|NCT00621764|P1|Participant Flow|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454566|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454567|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454569|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454570|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454571|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454572|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454573|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454574|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454575|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454576|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454577|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454578|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart.
454579|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454580|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454581|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454582|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454583|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454584|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454585|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454586|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454587|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454588|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
454589|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454590|NCT00621764|E4|Reported Event|Hepatitis A/JE CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
454591|NCT00621764|E3|Reported Event|JE CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454592|NCT00621764|E2|Reported Event|Hepatitis A/JE CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
454593|NCT00621764|E1|Reported Event|JE CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
454594|NCT00621777|B3|Baseline|Total|Total of all reporting groups
454595|NCT00621777|B2|Baseline|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.
In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
454596|NCT00621777|B1|Baseline|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year.
Varenicline: At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.
In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
454627|NCT00621855|P3|Participant Flow|110mg Dabigatran Etexilate|26 week blinded treatment
454628|NCT00621855|P2|Participant Flow|75mg Dabigatran Etexilate|26 week blinded treatment
454597|NCT00621777|P2|Participant Flow|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.
In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
454598|NCT00621777|P1|Participant Flow|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.
Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks.
Double-Blind, Placebo-Controlled, Relapse-Prevention Phase:
Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
454599|NCT00621777|O2|Outcome|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.
In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
454600|NCT00621777|O1|Outcome|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year.
Varenicline: At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.
In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
454601|NCT00621777|E3|Reported Event|Placebo|2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52
454602|NCT00621777|E2|Reported Event|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.
2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
454603|NCT00621777|E1|Reported Event|Varenicline Open Label (Open Phase)|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.
1. Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks."
454604|NCT00621842|B1|Baseline|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454605|NCT00621842|P1|Participant Flow|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454606|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454607|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454608|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454609|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454610|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454611|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454612|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454613|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454614|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454615|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454616|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454617|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454618|NCT00621842|E1|Reported Event|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
454619|NCT00621855|B6|Baseline|Total|Total of all reporting groups
454620|NCT00621855|B5|Baseline|Placebo|26 week blinded treatment
454621|NCT00621855|B4|Baseline|150mg Dabigatran Etexilate|26 week blinded treatment
454622|NCT00621855|B3|Baseline|110mg Dabigatran Etexilate|26 week blinded treatment
454632|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
454633|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
454634|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
454635|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
454636|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
454637|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
454638|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
454639|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
454640|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
454641|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
454642|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
454643|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
454644|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
454645|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
454646|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
454647|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
454648|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
454649|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
454650|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
454651|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
454652|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
454653|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
454654|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
454655|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
454656|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
454657|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
454658|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
454659|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
454660|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
454661|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
454662|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
454663|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
454664|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
454665|NCT00621855|E5|Reported Event|Placebo|26 week blinded treatment
454666|NCT00621855|E4|Reported Event|150mg Dabigatran Etexilate|26 week blinded treatment
454667|NCT00621855|E3|Reported Event|110mg Dabigatran Etexilate|26 week blinded treatment
454668|NCT00621855|E2|Reported Event|75mg Dabigatran Etexilate|26 week blinded treatment
454669|NCT00621855|E1|Reported Event|50mg Dabigatran Etexilate|26 week blinded treatment
454670|NCT00621933|B1|Baseline|All Patients|All patients receiving cataract surgery
454671|NCT00621933|P1|Participant Flow|All Patients|All patients receiving cataract surgery
454672|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
454673|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
454674|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
454675|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
454676|NCT00621933|E1|Reported Event|All Patients|All patients receiving cataract surgery
454677|NCT00621946|B3|Baseline|Total|Total of all reporting groups
454678|NCT00621946|B2|Baseline|Placebo|Placebo Matching Escitalopram taken orally daily.
454679|NCT00621946|B1|Baseline|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
454680|NCT00621946|P2|Participant Flow|Matching Placebo|Placebo Matching Escitalopram taken orally daily (for a 12-week duration).
454681|NCT00621946|P1|Participant Flow|Escitalopram|Once daily oral administration (for a 12-week duration) of 10 mg escitalopram tablets with an increase to 20 mg in those with a less than 30% decrease in HAM-D scores at week 4.
454682|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
454683|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
454684|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
454685|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
454686|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
454687|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
454688|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
454689|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
454690|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
454691|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
454692|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
454693|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
454694|NCT00621946|E2|Reported Event|Placebo|Placebo Matching Escitalopram taken orally daily.
454695|NCT00621946|E1|Reported Event|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
454696|NCT00621959|B3|Baseline|Total|Total of all reporting groups
454697|NCT00621959|B2|Baseline|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
454698|NCT00621959|B1|Baseline|Placebo|Matched placebo tablets once daily
454699|NCT00621959|P2|Participant Flow|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
454700|NCT00621959|P1|Participant Flow|Placebo|Matched placebo tablets once daily
454701|NCT00621959|O2|Outcome|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
454703|NCT00621959|O2|Outcome|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
454704|NCT00621959|O1|Outcome|Placebo|Matched placebo tablets once daily
454705|NCT00621959|E2|Reported Event|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
454706|NCT00621959|E1|Reported Event|Placebo|Matched placebo tablets once daily
454707|NCT00621985|B1|Baseline|Experimental Group|These subjects were admitted twice, once while on baseline hydrocortisone and once on dexamethasone.
454708|NCT00621985|P1|Participant Flow|Experimental|Baseline hydrocortisone was given at a dose determined by the subject's primary endocrinologist and was given either 2 or 3 times per day as per their home regimen. Experimental therapy with nocturnal dexamethasone given at a dose equivalent to 1/50th of the total daily hydrocortisone dose. This dose was given at 10 PM for three nights with the admission to the hospital occurring on the 3rd day prior to the 3rd evening dose.
454709|NCT00621985|O2|Outcome|Hydrocortisone Admission|This is the first admission of the protocol during which the subject received hydrocortisone.
454710|NCT00621985|O1|Outcome|Dexamethasone Admission|This is the second admission of the protocol during which the subject received dexamethasone.
454711|NCT00621985|E2|Reported Event|Hydrocortisone Admission|This is the first admission of the protocol during which the subject received hydrocortisone.
454712|NCT00621985|E1|Reported Event|Dexamethasone Admission|This is the second admission of the protocol during which the subject received dexamethasone.
454713|NCT00622167|B1|Baseline|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
454714|NCT00622167|P1|Participant Flow|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
454715|NCT00622167|O1|Outcome|Plaque Characteristics|Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology.
454716|NCT00622167|E1|Reported Event|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
454717|NCT00607789|B3|Baseline|Total|Total of all reporting groups
454718|NCT00607789|B2|Baseline|Placebo Group|Participants who were randomized to 30-120 mg/day of sugar pill for 12 weeks
454719|NCT00607789|B1|Baseline|Duloxetine Group|Participants were randomized to 30-120 mg/day of duloxetine for 12 weeks
454720|NCT00607789|P2|Participant Flow|Placebo Group|Placebo tablets (identical to duloxetine tablets), 30-120 mg/d given over 12-week period
454721|NCT00607789|P1|Participant Flow|Duloxetine Group|30-120 mg/day of duloxetine during a 12-week period
454722|NCT00607789|O2|Outcome|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
454723|NCT00607789|O1|Outcome|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks
454724|NCT00607789|O2|Outcome|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
454725|NCT00607789|O1|Outcome|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks
454726|NCT00607789|E2|Reported Event|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
454727|NCT00607789|E1|Reported Event|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks.
454728|NCT00607815|B3|Baseline|Total|Total of all reporting groups
454729|NCT00607815|B2|Baseline|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
454730|NCT00607815|B1|Baseline|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
454731|NCT00607815|P2|Participant Flow|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
454732|NCT00607815|P1|Participant Flow|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
454733|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy
Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
454734|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy
Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
455091|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
454735|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy
Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
454736|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy
Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
454737|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy
Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
454738|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy
Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
454739|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy
Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
454740|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy
Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
454741|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
454742|NCT00607815|O1|Outcome|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
454743|NCT00607815|E2|Reported Event|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
454744|NCT00607815|E1|Reported Event|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
454745|NCT00607867|B3|Baseline|Total|Total of all reporting groups
454746|NCT00607867|B2|Baseline|Control Diet|A weight maintenance, control diet consisting 55% carbohydrate, 15% protein, 30% fat
454747|NCT00607867|B1|Baseline|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% carbohydrate, 30% protein, and 40% fat.
454748|NCT00607867|P2|Participant Flow|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
454749|NCT00607867|P1|Participant Flow|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
454750|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
454751|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
454752|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
454753|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
454754|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
454755|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
454756|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
454757|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
454758|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
454759|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
454760|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
454761|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
454762|NCT00607867|E2|Reported Event|Control Diet|"A weight maintenance, control diet consisting of 55% carbohydrate, 15% protein, 30% fat will be given to subjects on metformin. All food will be provided for 5 weeks.
Control Diet: A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat"
454794|NCT00608465|O1|Outcome|All Patients|The study was never unblinded as enrollment was never completed.
454763|NCT00607867|E1|Reported Event|LoBAG30 Diet|"A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.
LoBAG30 diet: A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat."
454764|NCT00607880|B3|Baseline|Total|Total of all reporting groups
454765|NCT00607880|B2|Baseline|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
454766|NCT00607880|B1|Baseline|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
454767|NCT00607880|P2|Participant Flow|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
454768|NCT00607880|P1|Participant Flow|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
454769|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
454770|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
454771|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
454772|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
454773|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
454774|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
454775|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
454776|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
454777|NCT00607880|E2|Reported Event|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
454778|NCT00607880|E1|Reported Event|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
454779|NCT00608426|B3|Baseline|Total|Total of all reporting groups
454780|NCT00608426|B2|Baseline|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
454781|NCT00608426|B1|Baseline|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
454782|NCT00608426|P2|Participant Flow|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
454783|NCT00608426|P1|Participant Flow|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
454784|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
454785|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
454786|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
454787|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
454788|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
454789|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
454790|NCT00608426|E2|Reported Event|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
454791|NCT00608426|E1|Reported Event|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
454792|NCT00608465|B1|Baseline|All Patients|The study was never unblinded as enrollment was never completed.
454793|NCT00608465|P1|Participant Flow|All Patients|The study was never unblinded as enrollment was never completed.
454795|NCT00608465|O1|Outcome|All Patients|The study was never unblinded as enrollment was never completed.
454796|NCT00608465|E1|Reported Event|All Patients|The study was never unblinded as enrollment was never completed.
454797|NCT00608491|B3|Baseline|Total|Total of all reporting groups
454798|NCT00608491|B2|Baseline|Ultrafiltration|Participants will receive ultrafiltration
454799|NCT00608491|B1|Baseline|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454800|NCT00608491|P2|Participant Flow|Ultrafiltration|Participants will receive ultrafiltration
454801|NCT00608491|P1|Participant Flow|Stepped Pharmacologic Care|Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes
454802|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454803|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454804|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454805|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454806|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454807|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454808|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454809|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454810|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454811|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454812|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454813|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454814|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454815|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454816|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454817|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454818|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454819|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454820|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454821|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454822|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454823|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454824|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454825|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454826|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454827|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454828|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454829|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454830|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454831|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454832|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454833|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454834|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454835|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454836|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454837|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454838|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454839|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454840|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454841|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454842|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454843|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454844|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454845|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454846|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454847|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454848|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454849|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454850|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454851|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454852|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454853|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454854|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454855|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454856|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454920|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454857|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454858|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454859|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454860|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
455100|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
454861|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454862|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454863|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454864|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454865|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454866|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454867|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454868|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454869|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454870|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454871|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454872|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454873|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454874|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454875|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454876|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454877|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454878|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454879|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454880|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454881|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454882|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454883|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454884|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454885|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454886|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454887|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454888|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454889|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454890|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454891|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454892|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454893|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454894|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454895|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454896|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454897|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454898|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454899|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454900|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454901|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454902|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454903|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454904|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454905|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454906|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454907|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454908|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454909|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454910|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454911|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454912|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454913|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454914|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454915|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454916|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454917|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454918|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454919|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454921|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454922|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454923|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454924|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454925|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454926|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454927|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454928|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454929|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454930|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454931|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454932|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454933|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454934|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454935|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454936|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454937|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454938|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454939|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454940|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
454941|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454942|NCT00608491|E2|Reported Event|Ultrafiltration|Participants will receive ultrafiltration
454943|NCT00608491|E1|Reported Event|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
454944|NCT00608517|B4|Baseline|Total|Total of all reporting groups
454945|NCT00608517|B3|Baseline|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
454946|NCT00608517|B2|Baseline|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
454947|NCT00608517|B1|Baseline|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
454948|NCT00608517|P3|Participant Flow|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
454949|NCT00608517|P2|Participant Flow|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
454950|NCT00608517|P1|Participant Flow|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
454951|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
454952|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
454953|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
454954|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
454955|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
454956|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
454957|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
454958|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
454959|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
454960|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
455092|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
455093|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
454961|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
455043|NCT00608634|O1|Outcome|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
454962|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
454963|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
454964|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
454965|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
454966|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
454967|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
454968|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours
454969|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
454970|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
454971|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
454972|NCT00608517|E3|Reported Event|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
454973|NCT00608517|E2|Reported Event|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
454974|NCT00608517|E1|Reported Event|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
454975|NCT00608530|B3|Baseline|Total|Total of all reporting groups
454976|NCT00608530|B2|Baseline|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
454977|NCT00608530|B1|Baseline|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specifc goals for functioning (e.g., walking 30 minutes daily)."
454978|NCT00608530|P2|Participant Flow|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach"
454979|NCT00608530|P1|Participant Flow|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
454980|NCT00608530|O2|Outcome|Supportive Care|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks
454981|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks
454982|NCT00608530|O2|Outcome|Supportive Care|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks
454983|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks
454984|NCT00608530|O2|Outcome|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
454985|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specifc goals for functioning (e.g., walking 30 minutes daily)."
454986|NCT00608530|E2|Reported Event|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Rogerian psychotherapy: Rogerian therapists encourage individuals to identify goals and solutions using a supportive, reflective, empathic appraoch rather than a directive or prescriptive approach"
454987|NCT00608530|E1|Reported Event|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
455039|NCT00608634|O2|Outcome|Low Dose 0.30% POH|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
454988|NCT00608543|B1|Baseline|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
454989|NCT00608543|P1|Participant Flow|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
454990|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
454991|NCT00608543|O1|Outcome|Spatial Working Memory Between Errors for 6-move Problems|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
454992|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
454993|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
454994|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
454995|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
454996|NCT00608543|E1|Reported Event|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
454997|NCT00608569|B3|Baseline|Total|Total of all reporting groups
454998|NCT00608569|B2|Baseline|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
454999|NCT00608569|B1|Baseline|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
455000|NCT00608569|P2|Participant Flow|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
455001|NCT00608569|P1|Participant Flow|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
455002|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
455003|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
455004|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
455005|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
455006|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
455007|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
455008|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
455009|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
455010|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
455011|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
455012|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
455013|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
455014|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
455015|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
455016|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
455017|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
455018|NCT00608569|E2|Reported Event|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
455019|NCT00608569|E1|Reported Event|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
455020|NCT00608582|B3|Baseline|Total|Total of all reporting groups
455040|NCT00608634|O1|Outcome|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
455041|NCT00608634|O3|Outcome|High Dose POH 0.76%|Patients apply POH cream (0.76%) as in arm II.
455094|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
455042|NCT00608634|O2|Outcome|Low Dose POH 0.30%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
455099|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
455021|NCT00608582|B2|Baseline|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.
The patients then receive a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
455022|NCT00608582|B1|Baseline|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
455023|NCT00608582|P2|Participant Flow|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.
There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.
The patients then receive a series of 10 Real rTMS treatments.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
455024|NCT00608582|P1|Participant Flow|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
455025|NCT00608582|O2|Outcome|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.
There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.
The patients then receive a series of 10 Real rTMS treatments.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
455026|NCT00608582|O1|Outcome|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
455027|NCT00608582|O2|Outcome|Sham rTMS|Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
455028|NCT00608582|O1|Outcome|Real rTMS|"These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
455029|NCT00608582|E2|Reported Event|Sham rTMS|Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
455030|NCT00608582|E1|Reported Event|Real rTMS|"These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
455031|NCT00608634|B4|Baseline|Total|Total of all reporting groups
455032|NCT00608634|B3|Baseline|Arm III|Patients apply POH cream (0.76%) as in arm II.
455033|NCT00608634|B2|Baseline|Arm II|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
455034|NCT00608634|B1|Baseline|Arm I|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
455035|NCT00608634|P3|Participant Flow|High Dose POH 0.76%|Patients apply POH cream (0.76%) as in arm II.
455036|NCT00608634|P2|Participant Flow|Low Dose POH 0.30%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
455037|NCT00608634|P1|Participant Flow|Placbeo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
455038|NCT00608634|O3|Outcome|High Dose 0.76% POH|Patients apply POH cream (0.76%) as in arm II.
455089|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
455044|NCT00608634|E3|Reported Event|High Dose POH 0.76%|Patients apply POH cream (0.76%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
455045|NCT00608634|E2|Reported Event|Low Dose POH 0.3%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
455046|NCT00608634|E1|Reported Event|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
455047|NCT00614198|B3|Baseline|Total|Total of all reporting groups
455048|NCT00614198|B2|Baseline|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
455049|NCT00614198|B1|Baseline|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
455050|NCT00614198|P2|Participant Flow|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
455051|NCT00614198|P1|Participant Flow|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
455052|NCT00614198|O2|Outcome|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
455053|NCT00614198|O1|Outcome|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
455054|NCT00614198|E2|Reported Event|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
455055|NCT00614198|E1|Reported Event|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
455056|NCT00614315|B1|Baseline|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
455057|NCT00614315|P1|Participant Flow|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
455058|NCT00614315|O1|Outcome|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
455059|NCT00614315|O1|Outcome|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
455060|NCT00614315|E1|Reported Event|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
455061|NCT00614380|B5|Baseline|Total|Total of all reporting groups
455062|NCT00614380|B4|Baseline|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
455063|NCT00614380|B3|Baseline|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
455064|NCT00614380|B2|Baseline|Telmisartan 80mg and Amlodipine 5mg|
455065|NCT00614380|B1|Baseline|Telmisartan 40mg and Amlodipine 5mg|
455066|NCT00614380|P4|Participant Flow|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
455067|NCT00614380|P3|Participant Flow|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
455068|NCT00614380|P2|Participant Flow|Telmisartan 80mg and Amlodipine 5mg|
455069|NCT00614380|P1|Participant Flow|Telmisartan 40mg and Amlodipine 5mg|
455070|NCT00614380|O3|Outcome|Pre-titration: Total|
455071|NCT00614380|O2|Outcome|Pre-titration: No (DBP>=90 mmHg)|
455072|NCT00614380|O1|Outcome|Pre-titration: Yes (DBP<90 mmHg)|
455073|NCT00614380|O1|Outcome|Total|
455074|NCT00614380|O1|Outcome|Total|
455075|NCT00614380|O3|Outcome|Pre-antihypertensive: Total|
455076|NCT00614380|O2|Outcome|Pre-antihypertensive: No (DBP>=90 mmHg)|
455077|NCT00614380|O1|Outcome|Pre-antihypertensive: Yes (DBP<90 mmHg)|
455078|NCT00614380|O1|Outcome|Total|
455079|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
455080|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
455081|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
455082|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
455083|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
455084|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
455085|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
455086|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
455087|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
455088|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
455095|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
455096|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
455097|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
455098|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
455103|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
455104|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
455105|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
455106|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
455107|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
455108|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
455109|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
455110|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
455111|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
455112|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
455113|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
455114|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
455115|NCT00614380|E2|Reported Event|Telmisartan 80mg and Amlodipine 5mg|
455116|NCT00614380|E1|Reported Event|Telmisartan 40mg and Amlodipine 5mg|
455117|NCT00614393|B6|Baseline|Total|Total of all reporting groups
455118|NCT00614393|B5|Baseline|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
455119|NCT00614393|B4|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455120|NCT00614393|B3|Baseline|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455121|NCT00614393|B2|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455122|NCT00614393|B1|Baseline|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455123|NCT00614393|P5|Participant Flow|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received a cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
455124|NCT00614393|P4|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455125|NCT00614393|P3|Participant Flow|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455126|NCT00614393|P2|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the open-label (OL) portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV one time every two weeks (Q2W) for up to 32 months of treatment.
455127|NCT00614393|P1|Participant Flow|Dalotuzumab 10 mg/kg Q1W (DB)|In double-blind (DB) Week 1, participants received cetuximab 400 mg/m^2 intravenously (IV) loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV one time each week (Q1W) maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455185|NCT00614445|E1|Reported Event|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
455128|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
455129|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455130|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455131|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455132|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455133|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
455134|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455135|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455136|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455137|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455138|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
455139|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455140|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455141|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455142|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455373|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455143|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
455144|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455145|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455146|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455147|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455148|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
455149|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455150|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455151|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455152|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455153|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
455154|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455155|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455156|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455157|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455418|NCT00614939|O1|Outcome|Placebo|Placebo
455158|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
455159|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455160|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455161|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455162|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455163|NCT00614393|E5|Reported Event|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
455164|NCT00614393|E4|Reported Event|Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455165|NCT00614393|E3|Reported Event|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455166|NCT00614393|E2|Reported Event|Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
455167|NCT00614393|E1|Reported Event|Dalotuzumab 10 mg/kg Q1W (BD)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
455168|NCT00614406|B3|Baseline|Total|Total of all reporting groups
455169|NCT00614406|B2|Baseline|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
455170|NCT00614406|B1|Baseline|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
455171|NCT00614406|P2|Participant Flow|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
455172|NCT00614406|P1|Participant Flow|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
455173|NCT00614406|O2|Outcome|Placebo|Placebo cycle orally, daily x1 menstrual cycle [cycle = length of menstrual cycle]
455174|NCT00614406|O1|Outcome|Active Drug|Active drug(celecoxib 400 mg orally, daily for 1 menstrual cycle) cycle [cycle = length of menstrual cycle]
455175|NCT00614406|E2|Reported Event|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
455176|NCT00614406|E1|Reported Event|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
455177|NCT00614445|B3|Baseline|Total|Total of all reporting groups
455178|NCT00614445|B2|Baseline|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
455179|NCT00614445|B1|Baseline|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
455180|NCT00614445|P2|Participant Flow|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
455181|NCT00614445|P1|Participant Flow|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
455182|NCT00614445|O2|Outcome|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
455183|NCT00614445|O1|Outcome|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
455184|NCT00614445|E2|Reported Event|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
455186|NCT00614458|B1|Baseline|Effect on Latent HIV of Adding Raltegravir and/or VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
455187|NCT00614458|P1|Participant Flow|Effect on Latent HIV of Adding Raltegravir and VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and Valproic acid (VPA) and current antiretroviral therapy (ART) on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
455188|NCT00614458|O1|Outcome|Effect on Latent HIV of Adding Raltegravir and VPA to ART|
455189|NCT00614458|E1|Reported Event|Effect on Latent HIV of Adding Raltegravir and/or VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
455190|NCT00614484|B1|Baseline|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
455191|NCT00614484|P1|Participant Flow|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
455192|NCT00614484|O1|Outcome|Chemotherapy and Proton Therapy|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
455193|NCT00614484|O1|Outcome|Chemothrapy and Proton Therapy|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
455194|NCT00614484|E1|Reported Event|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
455195|NCT00614523|B3|Baseline|Total|Total of all reporting groups
455196|NCT00614523|B2|Baseline|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455197|NCT00614523|B1|Baseline|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455198|NCT00614523|P2|Participant Flow|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455199|NCT00614523|P1|Participant Flow|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455200|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455201|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455202|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455203|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455204|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455205|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455206|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455207|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455208|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455209|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455419|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
455210|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455211|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455377|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455212|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455213|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455214|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455215|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455216|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455217|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455218|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455219|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455220|NCT00614523|E2|Reported Event|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
455221|NCT00614523|E1|Reported Event|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
455222|NCT00614575|B1|Baseline|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
455223|NCT00614575|P1|Participant Flow|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
455224|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
455225|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
455241|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455242|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455378|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455226|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
455227|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
455228|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
455229|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
455230|NCT00614575|E1|Reported Event|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
455231|NCT00614614|B3|Baseline|Total|Total of all reporting groups
455232|NCT00614614|B2|Baseline|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455233|NCT00614614|B1|Baseline|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
455234|NCT00614614|P5|Participant Flow|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455235|NCT00614614|P4|Participant Flow|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455236|NCT00614614|P3|Participant Flow|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455237|NCT00614614|P2|Participant Flow|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455238|NCT00614614|P1|Participant Flow|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 1 Group] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Menhibrix 2 Group], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 2 Group].
455239|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455240|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455420|NCT00614939|O1|Outcome|Placebo|Placebo
455243|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455244|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455245|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455246|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455247|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455248|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455249|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455250|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455251|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455252|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455253|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455254|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455255|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455256|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455257|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455258|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455259|NCT00614614|O2|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455260|NCT00614614|O1|Outcome|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
455261|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
455262|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
455263|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455264|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455265|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455266|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
455267|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455268|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455269|NCT00614614|O2|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455270|NCT00614614|O1|Outcome|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
455271|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455272|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455273|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455274|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455275|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455276|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455277|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455278|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455279|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455280|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455281|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455282|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455283|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455284|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455285|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455286|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455287|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455288|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455289|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455290|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455291|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455292|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455293|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455294|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455295|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455296|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455297|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455298|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455299|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455300|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455301|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455302|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455303|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455304|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455305|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455306|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455307|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455308|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455309|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455310|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455311|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455312|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455313|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455314|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455315|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455316|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455317|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455318|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455319|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455320|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455321|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455322|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455323|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455324|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455325|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455326|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455327|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455328|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455329|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455330|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455331|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455332|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455333|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455334|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455335|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455336|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455337|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455338|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455339|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455340|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455341|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455342|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455343|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455344|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455345|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455346|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455347|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455348|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455349|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455350|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455351|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455352|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455353|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455354|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455355|NCT00614614|E5|Reported Event|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455356|NCT00614614|E4|Reported Event|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455357|NCT00614614|E3|Reported Event|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
455358|NCT00614614|E2|Reported Event|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
455359|NCT00614614|E1|Reported Event|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
455360|NCT00614744|B3|Baseline|Total|Total of all reporting groups
455361|NCT00614744|B2|Baseline|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455362|NCT00614744|B1|Baseline|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455363|NCT00614744|P2|Participant Flow|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455364|NCT00614744|P1|Participant Flow|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455365|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455366|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455367|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455368|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455369|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455370|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455371|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455372|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455421|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
455374|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455375|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455376|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455379|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455380|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455381|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455382|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455383|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455384|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455385|NCT00614744|E2|Reported Event|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
455386|NCT00614744|E1|Reported Event|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
455387|NCT00614874|B1|Baseline|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
455388|NCT00614874|P1|Participant Flow|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
455389|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
455390|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
455391|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
455392|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
455393|NCT00614874|E1|Reported Event|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
455394|NCT00614913|B1|Baseline|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
455395|NCT00614913|P1|Participant Flow|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
455396|NCT00614913|O1|Outcome|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
455397|NCT00614913|O1|Outcome|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
455398|NCT00614913|E1|Reported Event|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
455399|NCT00614926|B3|Baseline|Total|Total of all reporting groups
455400|NCT00614926|B2|Baseline|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
455401|NCT00614926|B1|Baseline|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
455402|NCT00614926|P2|Participant Flow|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
455403|NCT00614926|P1|Participant Flow|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
455404|NCT00614926|O2|Outcome|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
455405|NCT00614926|O1|Outcome|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
455406|NCT00614926|O2|Outcome|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
455407|NCT00614926|O1|Outcome|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
455408|NCT00614926|E2|Reported Event|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
455409|NCT00614926|E1|Reported Event|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
455410|NCT00614939|B3|Baseline|Total|Total of all reporting groups
455411|NCT00614939|B2|Baseline|Saxa|Saxagliptin 2.5 mg once daily oral dose
455412|NCT00614939|B1|Baseline|Placebo|Placebo
455413|NCT00614939|P2|Participant Flow|Saxa|Saxagliptin 2.5 mg once daily oral dose
455414|NCT00614939|P1|Participant Flow|Placebo|Placebo
455415|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
455416|NCT00614939|O1|Outcome|Placebo|Placebo
455417|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
455443|NCT00614939|E2|Reported Event|Saxa|Saxagliptin 2.5 mg once daily oral dose
455444|NCT00614939|E1|Reported Event|Placebo|Placebo
455445|NCT00614991|B7|Baseline|Total|Total of all reporting groups
455446|NCT00614991|B6|Baseline|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
455447|NCT00614991|B5|Baseline|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
455448|NCT00614991|B4|Baseline|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
455449|NCT00614991|B3|Baseline|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
455450|NCT00614991|B2|Baseline|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
455451|NCT00614991|B1|Baseline|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
455452|NCT00614991|P6|Participant Flow|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
455453|NCT00614991|P5|Participant Flow|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
455454|NCT00614991|P4|Participant Flow|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
455455|NCT00614991|P3|Participant Flow|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
455456|NCT00614991|P2|Participant Flow|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
455457|NCT00614991|P1|Participant Flow|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
455458|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
455459|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
455460|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
455461|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
455462|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
455463|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
455464|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
455465|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID"
455466|NCT00614991|O1|Outcome|Group A & B|Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Group B Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
455467|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
455468|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
455469|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
455470|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
455471|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
455472|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
455473|NCT00614991|O6|Outcome|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
455474|NCT00614991|O5|Outcome|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
455475|NCT00614991|O4|Outcome|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
455476|NCT00614991|O3|Outcome|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
455477|NCT00614991|O2|Outcome|Group B|Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
455478|NCT00614991|O1|Outcome|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
455479|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
455480|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
455481|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
455482|NCT00614991|E6|Reported Event|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
455483|NCT00614991|E5|Reported Event|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
455484|NCT00614991|E4|Reported Event|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
455485|NCT00614991|E3|Reported Event|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
455486|NCT00614991|E2|Reported Event|Group B|Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
455487|NCT00614991|E1|Reported Event|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
455488|NCT00615017|B7|Baseline|Total|Total of all reporting groups
455489|NCT00615017|B6|Baseline|Placebo|Placebo
455490|NCT00615017|B5|Baseline|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455491|NCT00615017|B4|Baseline|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455492|NCT00615017|B3|Baseline|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455493|NCT00615017|B2|Baseline|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455494|NCT00615017|B1|Baseline|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455495|NCT00615017|P6|Participant Flow|Placebo|Placebo
455496|NCT00615017|P5|Participant Flow|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455497|NCT00615017|P4|Participant Flow|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455498|NCT00615017|P3|Participant Flow|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455499|NCT00615017|P2|Participant Flow|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455500|NCT00615017|P1|Participant Flow|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455501|NCT00615017|O6|Outcome|Placebo|Placebo
455502|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455503|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455504|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455505|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455506|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455507|NCT00615017|O6|Outcome|Placebo|Placebo
455508|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455509|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455510|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455511|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455512|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455513|NCT00615017|O6|Outcome|Placebo|Placebo
455514|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455515|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455516|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455517|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455518|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455519|NCT00615017|O6|Outcome|Placebo|Placebo
455520|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455521|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455522|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455523|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455524|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455525|NCT00615017|O6|Outcome|Placebo|Placebo
455526|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455527|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455528|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455529|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455530|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455531|NCT00615017|O6|Outcome|Placebo|Placebo
455532|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455533|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455534|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455535|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455536|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455537|NCT00615017|O6|Outcome|Placebo|Placebo
455538|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455539|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455540|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455541|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455542|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455543|NCT00615017|O6|Outcome|Placebo|Placebo
455544|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455545|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455546|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455547|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455548|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455549|NCT00615017|O6|Outcome|Placebo|Placebo
455550|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455551|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455552|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455553|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455554|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455555|NCT00615017|O6|Outcome|Placebo|Placebo
455556|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455557|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455558|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455559|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455560|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455561|NCT00615017|O6|Outcome|Placebo|Placebo
455562|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455563|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455564|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
456439|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
455565|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455566|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455567|NCT00615017|O6|Outcome|Placebo|Placebo
455568|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455569|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455570|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455571|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455572|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455573|NCT00615017|O6|Outcome|Placebo|Placebo
455574|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455575|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455576|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455577|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455578|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455579|NCT00615017|O6|Outcome|Placebo|Placebo
455580|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455581|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455582|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455583|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455584|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455585|NCT00615017|O6|Outcome|Placebo|Placebo
455586|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455587|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455588|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455589|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455590|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455591|NCT00615017|O6|Outcome|Placebo|Placebo
455592|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455593|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455594|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455595|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455596|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455597|NCT00615017|O6|Outcome|Placebo|Placebo
455598|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455599|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455600|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455601|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455602|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455603|NCT00615017|O6|Outcome|Placebo|Placebo
455604|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455605|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455606|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455607|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455608|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455609|NCT00615017|O6|Outcome|Placebo|Placebo
455610|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455611|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455612|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455613|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455614|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455615|NCT00615017|O6|Outcome|Placebo|Placebo
455616|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455617|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455618|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
456440|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
455619|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455620|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455621|NCT00615017|O6|Outcome|Placebo|Placebo
455622|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455623|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455624|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455625|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455626|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455627|NCT00615017|O6|Outcome|Placebo|Placebo
455628|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455629|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455630|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455631|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455632|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455633|NCT00615017|O6|Outcome|Placebo|Placebo
455634|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455635|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455636|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455637|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455638|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455639|NCT00615017|O6|Outcome|Placebo|Placebo
455640|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455641|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455642|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455643|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455644|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455645|NCT00615017|E6|Reported Event|Placebo|Placebo
455646|NCT00615017|E5|Reported Event|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
455647|NCT00615017|E4|Reported Event|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
455648|NCT00615017|E3|Reported Event|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
455649|NCT00615017|E2|Reported Event|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
455650|NCT00615017|E1|Reported Event|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
455651|NCT00615030|B1|Baseline|Total Patients|
455652|NCT00615030|P12|Participant Flow|Sequence 12: Placebo, Indacaterol Evening, Indacaterol Morning|In period, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455653|NCT00615030|P11|Participant Flow|Sequence 11:Salmeterol,Indacaterol Morning,Indacaterol Evening|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455654|NCT00615030|P10|Participant Flow|Sequence 10: Indacaterol Evening, Placebo, Salmeterol|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455750|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
455751|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
455678|NCT00615056|B3|Baseline|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455765|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
455655|NCT00615030|P9|Participant Flow|Sequence 9:Indacaterol Morning, Salmeterol, Placebo|In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455656|NCT00615030|P8|Participant Flow|Sequence 8: Placebo, Indacaterol Morning, Salmeterol|In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via dry powder inhaler DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455657|NCT00615030|P7|Participant Flow|Sequence 7: Salmeterol, Indacaterol Evening, Placebo|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455658|NCT00615030|P6|Participant Flow|Sequence 6:Indacaterol Evening,Salmeterol, Indacaterol Morning|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455659|NCT00615030|P5|Participant Flow|Sequence 5: Indacaterol Morning, Placebo, Indacaterol Evening|In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455660|NCT00615030|P4|Participant Flow|Sequence 4: Placebo, Salmeterol, Indacaterol Evening|In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455661|NCT00615030|P3|Participant Flow|Sequence 3: Salmeterol, Placebo, Indacaterol Morning|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455662|NCT00615030|P2|Participant Flow|Sequence 2:Indacaterol Evening,Indacaterol Morning, Placebo|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455752|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
455663|NCT00615030|P1|Participant Flow|Sequence 1:Indacaterol Morning,Indacaterol Evening, Salmeterol|In period I, indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, Salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and second dose in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455664|NCT00615030|O6|Outcome|Placebo Evening|Placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via manufacturer’s proprietary DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455665|NCT00615030|O5|Outcome|Placebo Morning|Placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via manufacturer’s proprietary DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455666|NCT00615030|O4|Outcome|Salmeterol Evening|In the evening, Salmeterol 50 μg delivered via dry powder inhaler (DPI) along with placebo matching indacaterol via SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455667|NCT00615030|O3|Outcome|Salmeterol Morning|In the morning, Salmeterol 50 μg delivered via dry powder inhaler (DPI) along with placebo matching indacaterol via SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455668|NCT00615030|O2|Outcome|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455669|NCT00615030|O1|Outcome|Indacaterol Morning|Indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455670|NCT00615030|O2|Outcome|Placebo|During evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455671|NCT00615030|O1|Outcome|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via single dose dry powder inhaler (SDDPI) and placebo to salmeterol delivered via dry powder inhaler (DPI). Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455672|NCT00615030|E4|Reported Event|Placebo|During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
455673|NCT00615030|E3|Reported Event|Salmeterol|Salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning along with placebo matching indacaterol delivered by single dose dry powder inhaler (SDDPI). The second dose of salmeterol was administered in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
455674|NCT00615030|E2|Reported Event|Indacaterol Morning|Indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
455675|NCT00615030|E1|Reported Event|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
455676|NCT00615056|B5|Baseline|Total|Total of all reporting groups
455677|NCT00615056|B4|Baseline|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455753|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
455754|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
455755|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
455679|NCT00615056|B2|Baseline|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455680|NCT00615056|B1|Baseline|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455681|NCT00615056|P4|Participant Flow|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455682|NCT00615056|P3|Participant Flow|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455683|NCT00615056|P2|Participant Flow|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455684|NCT00615056|P1|Participant Flow|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455685|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455686|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455687|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455688|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455689|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455690|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455691|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455692|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455756|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
455757|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
455693|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455694|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455695|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455696|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455697|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455698|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455699|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455700|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455701|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455702|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455703|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455704|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455705|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455706|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455707|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455758|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
455759|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
455760|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
455761|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
455762|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
455763|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
455764|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
455708|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455709|NCT00615056|E4|Reported Event|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455710|NCT00615056|E3|Reported Event|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455711|NCT00615056|E2|Reported Event|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455712|NCT00615056|E1|Reported Event|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
455713|NCT00615069|B1|Baseline|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment.
455714|NCT00615069|P1|Participant Flow|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment. Participant Flow results reflect the final (5 year) data.
455715|NCT00615069|O1|Outcome|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up.
455716|NCT00615069|O1|Outcome|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up.
455717|NCT00615069|E1|Reported Event|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA).
455718|NCT00615108|B1|Baseline|Hypertension Patients|Telmisartan 40mg or 80 mg
455719|NCT00615108|P1|Participant Flow|Hypertension Patients|Telmisartan 40mg or 80 mg
455720|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
455721|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
455722|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
455723|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
455724|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
455725|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
455726|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
455727|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
455728|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
455729|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
455730|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
455731|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
455732|NCT00615108|E1|Reported Event|Hypertension Patients|Telmisartan 40mg or 80 mg
455733|NCT00615199|B5|Baseline|Total|Total of all reporting groups
455734|NCT00615199|B4|Baseline|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
455735|NCT00615199|B3|Baseline|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
455736|NCT00615199|B2|Baseline|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
455737|NCT00615199|B1|Baseline|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
455738|NCT00615199|P4|Participant Flow|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
455739|NCT00615199|P3|Participant Flow|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
455740|NCT00615199|P2|Participant Flow|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
455741|NCT00615199|P1|Participant Flow|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
455742|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
455743|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
455744|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
455745|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
455746|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
455747|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
455748|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
455749|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
455766|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
455767|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
455768|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
455769|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
455770|NCT00615199|E4|Reported Event|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
455771|NCT00615199|E3|Reported Event|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
455772|NCT00615199|E2|Reported Event|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
455773|NCT00615199|E1|Reported Event|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
455774|NCT00615264|B3|Baseline|Total|Total of all reporting groups
455775|NCT00615264|B2|Baseline|Placebo|"Mannitol 40 mg in 0.5 mL Lipid emulsion.
Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
455776|NCT00615264|B1|Baseline|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5mL Lipid emulsion.
DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
455777|NCT00615264|P2|Participant Flow|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.
Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
455778|NCT00615264|P1|Participant Flow|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.
DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
455779|NCT00615264|O2|Outcome|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.
Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
455780|NCT00615264|O1|Outcome|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.
DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
455781|NCT00615264|O2|Outcome|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.
Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
455782|NCT00615264|O1|Outcome|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.
DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
455783|NCT00615264|E2|Reported Event|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.
Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
455784|NCT00615264|E1|Reported Event|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.
DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
455785|NCT00615290|B1|Baseline|Aptivus|Patients treated by Aptivus in daily practice
455786|NCT00615290|P1|Participant Flow|Aptivus|Patients treated by Aptivus in daily practice
455787|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
455788|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
455789|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
455790|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
455791|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
455792|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
455793|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
455794|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
455795|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
455796|NCT00615290|E1|Reported Event|Aptivus|Patients treated by Aptivus in daily practice
455797|NCT00615433|B5|Baseline|Total|Total of all reporting groups
455798|NCT00615433|B4|Baseline|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
455799|NCT00615433|B3|Baseline|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
455800|NCT00615433|B2|Baseline|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
455801|NCT00615433|B1|Baseline|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
455802|NCT00615433|P4|Participant Flow|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
455837|NCT00615472|B1|Baseline|Inhaled Anesthesia|"Inhaled Anesthesia - isoflurane
Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
455838|NCT00615472|P2|Participant Flow|Intravenous Anesthesia|Intravenous Anesthesia - propofol, remifentanil
455871|NCT00615719|O1|Outcome|Computed Tomographic Coronary Angiography for Chest Pain Evalu|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA)
455902|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455803|NCT00615433|P3|Participant Flow|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
455804|NCT00615433|P2|Participant Flow|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
455805|NCT00615433|P1|Participant Flow|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
455806|NCT00615433|O4|Outcome|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
455807|NCT00615433|O3|Outcome|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
455808|NCT00615433|O2|Outcome|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
455809|NCT00615433|O1|Outcome|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
455810|NCT00615433|O4|Outcome|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
455811|NCT00615433|O3|Outcome|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
455812|NCT00615433|O2|Outcome|120mg|3 40 mg tablets taken orally once a day.
455813|NCT00615433|O1|Outcome|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
455814|NCT00615433|E4|Reported Event|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
455815|NCT00615433|E3|Reported Event|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
455816|NCT00615433|E2|Reported Event|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
455817|NCT00615433|E1|Reported Event|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
455818|NCT00615459|B1|Baseline|Total Patients|The safety population, included all patients who received at least one dose of study drug.
455819|NCT00615459|P4|Participant Flow|Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg|In period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
455839|NCT00615472|P1|Participant Flow|Inhaled Anesthesia|Inhaled Anesthesia - isoflurane
455870|NCT00615719|P1|Participant Flow|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
455820|NCT00615459|P3|Participant Flow|Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo|In period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
455821|NCT00615459|P2|Participant Flow|Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium|In period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
455822|NCT00615459|P1|Participant Flow|Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg|In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455823|NCT00615459|O4|Outcome|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455824|NCT00615459|O3|Outcome|Tiotropium 18 μg|Tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455825|NCT00615459|O2|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455826|NCT00615459|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455827|NCT00615459|O4|Outcome|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455828|NCT00615459|O3|Outcome|Tiotropium 18 μg|Tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455829|NCT00615459|O2|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455830|NCT00615459|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455831|NCT00615459|E4|Reported Event|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
455832|NCT00615459|E3|Reported Event|Tiotropium 18 μg|Tiotropium 18 μg once daily delivered via inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
455833|NCT00615459|E2|Reported Event|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
455834|NCT00615459|E1|Reported Event|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via single dose dry powder inhaler (SDDPI) and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
455835|NCT00615472|B3|Baseline|Total|Total of all reporting groups
455836|NCT00615472|B2|Baseline|Intravenous Anesthesia|"Intravenous Anesthesia - propofol, remifentanil
Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.
Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed"
456441|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
455840|NCT00615472|O2|Outcome|Group 2|"Intravenous Anesthesia - propofol, remifentanil
Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.
Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min."
455841|NCT00615472|O1|Outcome|Group 1|"Inhaled Anesthesia - isoflurane
Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
455842|NCT00615472|E2|Reported Event|Group 2|"Intravenous Anesthesia - propofol, remifentanil
Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.
Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min."
455843|NCT00615472|E1|Reported Event|Group 1|"Inhaled Anesthesia - isoflurane
Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
455844|NCT00615550|B3|Baseline|Total|Total of all reporting groups
455845|NCT00615550|B2|Baseline|Prochieve|Progesterone 8% Vaginal Gel
455846|NCT00615550|B1|Baseline|Placebo|placebo vaginal gel
455847|NCT00615550|P2|Participant Flow|Prochieve|Progesterone 8% Vaginal Gel
455848|NCT00615550|P1|Participant Flow|Placebo|placebo vaginal gel
455849|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
455850|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
455851|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
455852|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
455853|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
455854|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
455855|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
455856|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
455857|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
455858|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
455859|NCT00615550|E2|Reported Event|Prochieve|Progesterone 8% Vaginal Gel
455860|NCT00615550|E1|Reported Event|Placebo|placebo vaginal gel
455861|NCT00615589|B1|Baseline|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Fludarabine/Busulfan x 4 days:
Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.
Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.
The Fludarabine shall be administered prior to the Busulfan each day."
455862|NCT00615589|P1|Participant Flow|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Fludarabine/Busulfan x 4 days:
Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.
Busulfan: 3.2 mg/kg IV daily over 4 hours on days –5, –4, -3, and –2.
The Fludarabine shall be administered prior to the Busulfan each day."
455863|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Fludarabine/Busulfan x 4 days:
Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.
Busulfan: 3.2 mg/kg IV daily over 4 hours on days –5, –4, -3, and –2.
The Fludarabine shall be administered prior to the Busulfan each day."
455864|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Fludarabine/Busulfan x 4 days:
Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.
Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.
The Fludarabine shall be administered prior to the Busulfan each day."
455865|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Fludarabine/Busulfan x 4 days:
Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.
Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.
The Fludarabine shall be administered prior to the Busulfan each day."
455866|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Fludarabine/Busulfan x 4 days:
Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.
Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.
The Fludarabine shall be administered prior to the Busulfan each day."
455867|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Fludarabine/Busulfan x 4 days:
Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.
Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.
The Fludarabine shall be administered prior to the Busulfan each day."
455868|NCT00615589|E1|Reported Event|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Fludarabine/Busulfan x 4 days:
Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.
Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.
The Fludarabine shall be administered prior to the Busulfan each day."
455869|NCT00615719|B1|Baseline|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
455872|NCT00615719|E1|Reported Event|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
455873|NCT00615836|B5|Baseline|Total|Total of all reporting groups
455874|NCT00615836|B4|Baseline|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455875|NCT00615836|B3|Baseline|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455876|NCT00615836|B2|Baseline|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455877|NCT00615836|B1|Baseline|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455878|NCT00615836|P5|Participant Flow|Placebo|Participants took a placebo 'Melt' for 28 days to complete Part I of Study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt, continuing into Study CS31.
455879|NCT00615836|P4|Participant Flow|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
455880|NCT00615836|P3|Participant Flow|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
455881|NCT00615836|P2|Participant Flow|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
455882|NCT00615836|P1|Participant Flow|Desmopressin Melt 10 μg|"Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29, continuing in Study CS31.
During CS31, based on the results of CS29, participants were randomly assigned to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg)."
455883|NCT00615836|O5|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
455884|NCT00615836|O4|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
455885|NCT00615836|O3|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
455886|NCT00615836|O2|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455887|NCT00615836|O1|Outcome|Placebo|Participants took a placebo 'Melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt.
455888|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455889|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455890|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455891|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455892|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455893|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455894|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455895|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455896|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455897|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455898|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455899|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455900|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455901|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455963|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
455903|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455904|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455905|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455906|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455907|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455908|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455909|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455910|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455911|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455912|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455913|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455914|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455915|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455916|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455917|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455918|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455919|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455920|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455921|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455922|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455923|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455924|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455925|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455926|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455927|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455928|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455929|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455930|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455931|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455932|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455933|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455934|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
455964|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
455965|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
455935|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455936|NCT00615836|E5|Reported Event|Desmopressin Melt 100 μg|Participants received desmopressin melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
455937|NCT00615836|E4|Reported Event|Desmopressin Melt 50 μg|Participants received desmopressin melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
455938|NCT00615836|E3|Reported Event|Desmopressin Melt 25 μg|Participants received desmopressin melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
455939|NCT00615836|E2|Reported Event|Desmopressin Melt 10 μg|Participants received desmopressin melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to one of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
455940|NCT00615836|E1|Reported Event|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt.
455941|NCT00615901|B1|Baseline|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.
cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
455942|NCT00615901|P1|Participant Flow|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.
cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
455943|NCT00615901|O1|Outcome|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.
cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
455944|NCT00615901|E1|Reported Event|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.
cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
455945|NCT00615914|B1|Baseline|Pramipexole|Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated until symptom control was achieved. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
455946|NCT00615914|P1|Participant Flow|Pramipexole|Pramipexole tablets - oral administration (0.125 mg and 0.5 mg)
455947|NCT00615914|O1|Outcome|Pramipexole|Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
455948|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
455949|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
455950|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
455951|NCT00615914|E1|Reported Event|Pramipexole|Pramipexole tablets - oral administration (0.125 mg and 0.5 mg) was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
455952|NCT00615927|B3|Baseline|Total|Total of all reporting groups
455953|NCT00615927|B2|Baseline|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
455954|NCT00615927|B1|Baseline|Astrocytoma|Grade II Astrocytoma
455955|NCT00615927|P2|Participant Flow|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
455956|NCT00615927|P1|Participant Flow|Astrocytoma|Grade II Astrocytoma
455957|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
455958|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
455959|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
455960|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
455961|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
455962|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
455967|NCT00615927|E2|Reported Event|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
455968|NCT00615927|E1|Reported Event|Astrocytoma|Grade II Astrocytoma
455969|NCT00615992|B1|Baseline|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
455970|NCT00615992|P1|Participant Flow|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
455971|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
455972|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
455973|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
455974|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
455975|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
455976|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
455977|NCT00615992|E1|Reported Event|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
455978|NCT00616018|B1|Baseline|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
455979|NCT00616018|P1|Participant Flow|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
455980|NCT00616018|O1|Outcome|Acetaminophen|acetaminophen treatment group
455981|NCT00616018|O1|Outcome|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
455982|NCT00616018|E1|Reported Event|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
455983|NCT00616109|B1|Baseline|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
455984|NCT00616109|P1|Participant Flow|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
455985|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
455986|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
455987|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
455988|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy. All patients who have received at least one cycle of sunitinib will be considered evaluable for response.
455989|NCT00616109|E1|Reported Event|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
455990|NCT00616122|B1|Baseline|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
455991|NCT00616122|P1|Participant Flow|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
455992|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
455993|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
455994|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
455995|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
455996|NCT00616122|E1|Reported Event|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
455997|NCT00616200|B1|Baseline|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
455998|NCT00616200|P1|Participant Flow|Standard Diet Then Very Low Carbohydrate Diet|Two weeks of a carbohydrate rich diet was followed by four weeks of A Very Low Carbohydrate Diet. VLCD = <20g/day of carbohydrates
455999|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
456000|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
456001|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
456002|NCT00616200|E1|Reported Event|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
456003|NCT00616239|B1|Baseline|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
456004|NCT00616239|P1|Participant Flow|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
456005|NCT00616239|O1|Outcome|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
456006|NCT00616239|E1|Reported Event|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
456007|NCT00616343|B1|Baseline|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
456008|NCT00616343|P1|Participant Flow|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
456009|NCT00616343|O1|Outcome|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
456010|NCT00616343|E1|Reported Event|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
456011|NCT00622284|B3|Baseline|Total|Total of all reporting groups
456012|NCT00622284|B2|Baseline|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456013|NCT00622284|B1|Baseline|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456014|NCT00622284|P2|Participant Flow|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456015|NCT00622284|P1|Participant Flow|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456016|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456017|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456018|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456019|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456020|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456021|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456022|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456023|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456024|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456025|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456026|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456027|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456028|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456029|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456030|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456031|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456032|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456033|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456034|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456035|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456036|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456037|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456038|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456039|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456040|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456041|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456042|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456043|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456044|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456045|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456046|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456047|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456048|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456049|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456050|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456051|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456052|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456053|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456054|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456055|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456056|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456057|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456058|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456059|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456060|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456061|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456062|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456063|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456064|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456065|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456066|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456067|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456068|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456069|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456070|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456071|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456072|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456073|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456074|NCT00622284|E2|Reported Event|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
456075|NCT00622284|E1|Reported Event|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
456076|NCT00622336|B1|Baseline|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
456077|NCT00622336|P1|Participant Flow|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
456078|NCT00622336|O1|Outcome|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
456079|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
456080|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
456081|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
456082|NCT00622336|O1|Outcome|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
456083|NCT00622336|E2|Reported Event|Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
456084|NCT00622336|E1|Reported Event|Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
456085|NCT00622388|B1|Baseline|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456086|NCT00622388|P1|Participant Flow|Ofatumumab|Participants received 8 weekly intravenous (iv) infusions of ofatumumab: first infusion of 300 milligrams (mg), followed by 7 infusions of 1000 mg
456087|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456088|NCT00622388|O1|Outcome|Overall Study Arm|
456089|NCT00622388|O1|Outcome|Overall Study Arm|
456090|NCT00622388|O1|Outcome|Overall Study Arm|
456091|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456442|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
456092|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456093|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456094|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456096|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456097|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456098|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456099|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456100|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456101|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456102|NCT00622388|E1|Reported Event|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
456103|NCT00622401|B4|Baseline|Total|Total of all reporting groups
456104|NCT00622401|B3|Baseline|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12
Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells
Interleukin-12: Given subcutaneously at dose of 100ng/kg"
456105|NCT00622401|B2|Baseline|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12
Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells
Interleukin-12: Given subcutaneously at dose of 30ng/kg"
456106|NCT00622401|B1|Baseline|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only
Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
456107|NCT00622401|P3|Participant Flow|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12
Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells
Interleukin-12: Given subcutaneously at dose of 100ng/kg"
456108|NCT00622401|P2|Participant Flow|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12
Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells
Interleukin-12: Given subcutaneously at dose of 30ng/kg"
456109|NCT00622401|P1|Participant Flow|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only
Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
456110|NCT00622401|O1|Outcome|Group 1|"Dendritic Cell/Tumor Fusion Vaccine Only
Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
456111|NCT00622401|E1|Reported Event|Group 1|"Dendritic Cell/Tumor Fusion Vaccine Only
Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
456112|NCT00622427|B3|Baseline|Total|Total of all reporting groups
456113|NCT00622427|B2|Baseline|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
456114|NCT00622427|B1|Baseline|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
456115|NCT00622427|P2|Participant Flow|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
456116|NCT00622427|P1|Participant Flow|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
456117|NCT00622427|O2|Outcome|Placebo|QD for 14 days prior to sleep
456118|NCT00622427|O1|Outcome|Ramelteon|QD for 14 days prior to sleep
456119|NCT00622427|O2|Outcome|Placebo|QD for 14 days prior to sleep first
456120|NCT00622427|O1|Outcome|Ramelteon|QD for 14 days prior to sleep first
456121|NCT00622427|E2|Reported Event|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
456122|NCT00622427|E1|Reported Event|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
456123|NCT00622440|B3|Baseline|Total|Total of all reporting groups
456124|NCT00622440|B2|Baseline|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
456125|NCT00622440|B1|Baseline|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
456126|NCT00622440|P2|Participant Flow|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
456127|NCT00622440|P1|Participant Flow|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
456128|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
456129|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
456130|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
456131|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
456132|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
456133|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
456134|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
456443|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
456135|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
456136|NCT00622440|E2|Reported Event|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
456137|NCT00622440|E1|Reported Event|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
456138|NCT00622518|B3|Baseline|Total|Total of all reporting groups
456139|NCT00622518|B2|Baseline|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
456140|NCT00622518|B1|Baseline|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
456141|NCT00622518|P2|Participant Flow|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
456142|NCT00622518|P1|Participant Flow|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
456143|NCT00622518|O2|Outcome|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
456144|NCT00622518|O1|Outcome|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
456145|NCT00622518|O2|Outcome|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
456146|NCT00622518|O1|Outcome|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
456147|NCT00622518|E2|Reported Event|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
456148|NCT00622518|E1|Reported Event|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
456149|NCT00623428|B3|Baseline|Total|Total of all reporting groups
456150|NCT00623428|B2|Baseline|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
456151|NCT00623428|B1|Baseline|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
456152|NCT00623428|P2|Participant Flow|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
456153|NCT00623428|P1|Participant Flow|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with pegylated-interferon (peginterferon) alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
456154|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
456155|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
456156|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
456157|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
456172|NCT00623441|O1|Outcome|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
456444|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
456158|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
456159|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
456160|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
456161|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
456162|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
456163|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
456164|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
456165|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
456166|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
456167|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
456168|NCT00623428|E2|Reported Event|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
456169|NCT00623428|E1|Reported Event|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
456170|NCT00623441|B1|Baseline|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
456171|NCT00623441|P1|Participant Flow|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
456173|NCT00623441|E1|Reported Event|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
456174|NCT00623467|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456175|NCT00623467|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456176|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456177|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456178|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456179|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456180|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456181|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456182|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456183|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456184|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456185|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456186|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456187|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456188|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456189|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456190|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456191|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456192|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456193|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456194|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456195|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456196|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456197|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456198|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456199|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456228|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456362|NCT00623714|P2|Participant Flow|Fluticasone Then Placebo|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose, Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
456200|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456201|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456202|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456203|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456204|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456205|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456206|NCT00623467|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456207|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456208|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456209|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456210|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456211|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456212|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456213|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456214|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456215|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456216|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456217|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456218|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456219|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456220|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456221|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456222|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456223|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456224|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456225|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456226|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456227|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456229|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456230|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456231|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456232|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456233|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456234|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456235|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456236|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
456237|NCT00623467|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
456238|NCT00623480|B3|Baseline|Total|Total of all reporting groups
456239|NCT00623480|B2|Baseline|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
456240|NCT00623480|B1|Baseline|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
456241|NCT00623480|P2|Participant Flow|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
456242|NCT00623480|P1|Participant Flow|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
456243|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
456244|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
456245|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
456246|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
456247|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
456248|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
456249|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
456250|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
456251|NCT00623480|E2|Reported Event|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
456252|NCT00623480|E1|Reported Event|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
456253|NCT00623506|B3|Baseline|Total|Total of all reporting groups
456254|NCT00623506|B2|Baseline|Placebo|"Placebo
Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
456255|NCT00623506|B1|Baseline|Pregnenolone|"Pregnenolone
Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
456256|NCT00623506|P2|Participant Flow|Placebo|"Placebo
Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
456257|NCT00623506|P1|Participant Flow|Pregnenolone|"Pregnenolone
Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
456258|NCT00623506|O2|Outcome|Placebo|"Placebo
Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
456259|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone
Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
456260|NCT00623506|O2|Outcome|Placebo|"Placebo
Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
456261|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone
Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
456262|NCT00623506|O2|Outcome|Placebo|"Placebo
Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
456263|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone
Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
456264|NCT00623506|E2|Reported Event|Placebo|"Placebo
Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
456265|NCT00623506|E1|Reported Event|Pregnenolone|"Pregnenolone
Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
456266|NCT00623545|B1|Baseline|Single Arm Study of Exenatide Treatment|Subjects serve as their own controls. Measures of outcomes are performed before and at the end of treatment. Outcomes are based on the change in the variables.
456267|NCT00623545|P1|Participant Flow|Single Arm Study of Exenatide Treatment|Subjects serve as their own controls. Measures of outcome variables are made before treatment and again at the end of the1 treatment period made. Outcomes are based on the change in these variables.
456268|NCT00623545|O1|Outcome|Exenitide Treatment|
456269|NCT00623545|O1|Outcome|Exenitide Treatment|There is one treatment arm. Subjects serve as their own controls for the outcome measure. The measures are made before the treatment is started at during the end of the treatment.
456270|NCT00623545|E1|Reported Event|Single Arm Study of Exenatide Treatment|
456271|NCT00623597|B3|Baseline|Total|Total of all reporting groups
456272|NCT00623597|B2|Baseline|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456273|NCT00623597|B1|Baseline|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456274|NCT00623597|P2|Participant Flow|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456275|NCT00623597|P1|Participant Flow|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456276|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456277|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456353|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456354|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
456363|NCT00623714|P1|Participant Flow|Placebo Then Fluticasone|Days 1-2 Placebo twice a Day (b.i.d.) + Day 3 Placebo single dose, Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
456364|NCT00623714|O2|Outcome|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
456365|NCT00623714|O1|Outcome|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
456278|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456279|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456280|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456281|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456282|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456283|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456284|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456285|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456286|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456287|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456288|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456289|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456290|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456291|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456292|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456293|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456294|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456295|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456296|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456297|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456298|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456299|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456300|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456301|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456302|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456303|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456304|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456305|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456306|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456307|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456308|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456309|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456310|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456424|NCT00623779|P1|Participant Flow|AZD0837 150 mg|AZD0837 150 mg
456311|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456312|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456313|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456314|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456315|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456316|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456317|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456318|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456319|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456320|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456355|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456356|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
456357|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456321|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456322|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456323|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456324|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456325|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456326|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456327|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456328|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456329|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456330|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456358|NCT00623636|E3|Reported Event|Open-label MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456359|NCT00623636|E2|Reported Event|Double-blind MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
456360|NCT00623636|E1|Reported Event|Double-blind Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456331|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456332|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456333|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456334|NCT00623597|E3|Reported Event|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456335|NCT00623597|E2|Reported Event|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456336|NCT00623597|E1|Reported Event|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
456337|NCT00623636|B3|Baseline|Total|Total of all reporting groups
456338|NCT00623636|B2|Baseline|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
456339|NCT00623636|B1|Baseline|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456340|NCT00623636|P2|Participant Flow|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
456341|NCT00623636|P1|Participant Flow|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456342|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
456343|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456344|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
456345|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456346|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
456347|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456348|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
456349|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456350|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
456351|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
456352|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
456366|NCT00623714|O2|Outcome|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
456367|NCT00623714|O1|Outcome|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
456368|NCT00623714|E2|Reported Event|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
456369|NCT00623714|E1|Reported Event|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
456370|NCT00623727|B3|Baseline|Total|Total of all reporting groups
456371|NCT00623727|B2|Baseline|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
456372|NCT00623727|B1|Baseline|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
456373|NCT00623727|P2|Participant Flow|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
456374|NCT00623727|P1|Participant Flow|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
456375|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
456376|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
456377|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
456378|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
456379|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
456380|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
456381|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
456382|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
456383|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
456384|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
456385|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
456386|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
456387|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
456388|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
456389|NCT00623727|E4|Reported Event|rFVIII-FS/Pegylated Liposomes (BAY79-4980) - Extension|Reporting group 4 (RG4): Open Label Extension, 35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII-FS excipient reconstituted in WFI)
456390|NCT00623727|E3|Reported Event|rFVIII-FS/WFI (BAY14-2222) - Follow-up|Reporting group 3 (RG3): Open Label Follow-up, 25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
456391|NCT00623727|E2|Reported Event|rFVIII-FS/WFI (BAY14-2222) - Double Blind|Reporting group 2 (RG2): Double Blind Study, 25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
456425|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
456392|NCT00623727|E1|Reported Event|rFVIII-FS/Pegylated Liposomes (BAY79-4980) - Double Blind|Reporting Group 1 (RG1): Double Blind Study, 35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII-FS excipient reconstituted in WFI)
456393|NCT00623766|B3|Baseline|Total|Total of all reporting groups
456445|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
456446|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
456394|NCT00623766|B2|Baseline|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456395|NCT00623766|B1|Baseline|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456396|NCT00623766|P2|Participant Flow|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456397|NCT00623766|P1|Participant Flow|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456398|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg, IV in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456399|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg, IV in Corticosteroid-free Patients|"Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.
Ipilimumab: 10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance"
456400|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456401|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456402|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456403|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456404|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456405|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456426|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
456427|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
456428|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
456447|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
456448|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
456449|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
456450|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
456406|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456407|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456408|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456409|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456410|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456411|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456412|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456413|NCT00623766|O1|Outcome|Ipilimumab 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456414|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456415|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456416|NCT00623766|E2|Reported Event|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456417|NCT00623766|E1|Reported Event|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
456418|NCT00623779|B4|Baseline|Total|Total of all reporting groups
456419|NCT00623779|B3|Baseline|Standard Therapy|Standard Therapy
456420|NCT00623779|B2|Baseline|AZD0837 300 mg|AZD0837 300 mg
456421|NCT00623779|B1|Baseline|AZD0837 150 mg|AZD0837 150 mg
456422|NCT00623779|P3|Participant Flow|Standard Therapy|Standard Therapy
456423|NCT00623779|P2|Participant Flow|AZD0837 300 mg|AZD0837 300 mg
456471|NCT00623805|B2|Baseline|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456472|NCT00623805|B1|Baseline|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456473|NCT00623805|P2|Participant Flow|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456474|NCT00623805|P1|Participant Flow|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456475|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456476|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456477|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456478|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456479|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456480|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456481|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456482|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456561|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
456562|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
456483|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456484|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456485|NCT00623805|E2|Reported Event|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456486|NCT00623805|E1|Reported Event|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
456487|NCT00623831|B3|Baseline|Total|Total of all reporting groups
456488|NCT00623831|B2|Baseline|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
456515|NCT00623974|O3|Outcome|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456489|NCT00623831|B1|Baseline|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
456490|NCT00623831|P2|Participant Flow|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
456491|NCT00623831|P1|Participant Flow|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a dose-limiting toxicity (DLT) until the desired pyrogenic effect was observed.
456492|NCT00623831|O2|Outcome|Cohort 2 (Tumor Response Analysis Set)|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
456493|NCT00623831|O1|Outcome|Cohort 1 (Tumor Response Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
456494|NCT00623831|O1|Outcome|Cohort 1 (Immune Response Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
456495|NCT00623831|O1|Outcome|Cohort 1 (Safety Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
456496|NCT00623831|O2|Outcome|Cohort 2 (Safety Analysis Set)|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
456497|NCT00623831|O1|Outcome|Cohort 1 (Safety Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
456498|NCT00623831|E2|Reported Event|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
456499|NCT00623831|E1|Reported Event|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
456500|NCT00623935|B1|Baseline|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
456501|NCT00623935|P1|Participant Flow|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
456502|NCT00623935|O1|Outcome|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
456503|NCT00623935|O1|Outcome|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
456563|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456504|NCT00623935|E1|Reported Event|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
456505|NCT00623974|B5|Baseline|Total|Total of all reporting groups
456506|NCT00623974|B4|Baseline|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456507|NCT00623974|B3|Baseline|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456508|NCT00623974|B2|Baseline|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456509|NCT00623974|B1|Baseline|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456510|NCT00623974|P4|Participant Flow|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456511|NCT00623974|P3|Participant Flow|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456512|NCT00623974|P2|Participant Flow|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456513|NCT00623974|P1|Participant Flow|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456514|NCT00623974|O4|Outcome|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456516|NCT00623974|O2|Outcome|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456517|NCT00623974|O1|Outcome|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456518|NCT00623974|E4|Reported Event|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456519|NCT00623974|E3|Reported Event|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456520|NCT00623974|E2|Reported Event|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456521|NCT00623974|E1|Reported Event|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
456522|NCT00624052|B5|Baseline|Total|Total of all reporting groups
456523|NCT00624052|B4|Baseline|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
456524|NCT00624052|B3|Baseline|Titrated Telmisartan 80mg and Amlodipine 10mg|
456525|NCT00624052|B2|Baseline|Randomised Telmisartan 80mg and Amlodipine 10mg|
456526|NCT00624052|B1|Baseline|Telmisartan 40mg and Amlodipine 10mg|
456527|NCT00624052|P4|Participant Flow|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|Patients who were on either telmisartan 40 mg or 80mg and amlodipine 10mg plus another antihypertensive medication at their last study visit
456528|NCT00624052|P3|Participant Flow|Titrated Telmisartan 80mg and Amlodipine 10mg|Patients who were randomised to telmisartan 40mg and amlodipine 10mg but were titrated to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
456529|NCT00624052|P2|Participant Flow|Randomised Telmisartan 80mg and Amlodipine 10mg|Patients who were randomised to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
456530|NCT00624052|P1|Participant Flow|Telmisartan 40mg and Amlodipine 10mg|Patients who were randomised to telmisartan 40mg and amlodipine 10mg and were on this dose at their last study visit
456531|NCT00624052|O3|Outcome|Pre-titration: Total|
456532|NCT00624052|O2|Outcome|Pre-titration: No (DBP>=90 mmHg)|
456533|NCT00624052|O1|Outcome|Pre-titration: Yes (DBP<90 mmHg)|
456534|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456535|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456536|NCT00624052|O3|Outcome|Pre-antihypertensive: Total|
456537|NCT00624052|O2|Outcome|Pre-antihypertensive: No (DBP>=90 mmHg)|
456538|NCT00624052|O1|Outcome|Pre-antihypertensive: Yes (DBP<90 mmHg)|
456539|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456540|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
456541|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
456542|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
456543|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456544|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
456545|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
456546|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
456547|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456548|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
456549|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
456550|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
456551|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456552|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
456553|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
456554|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
456555|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456556|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
456557|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
456558|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
456559|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456560|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
456564|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
456565|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
456566|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
456567|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456568|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
456569|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
456570|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
456571|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456572|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
456573|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
456574|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
456575|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
456576|NCT00624052|E2|Reported Event|Telmisartan 80mg and Amlodipine 10mg|The 611 participants in the telmisartan 80mg/amlodipine 10mg (T80/A10) group include 436 patients in the randomised T80/A10 group + 91 patients in the uptitrated T80/A10 group + XX patients in the T80/A10 + add-on group
456577|NCT00624052|E1|Reported Event|Telmisartan 40mg and Amlodipine 10mg|The 838 participants in the telmisartan 40mg/amlodipine 10mg group includes all participants
456578|NCT00624065|B3|Baseline|Total|Total of all reporting groups
456579|NCT00624065|B2|Baseline|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
456580|NCT00624065|B1|Baseline|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
456581|NCT00624065|P2|Participant Flow|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
456582|NCT00624065|P1|Participant Flow|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
456583|NCT00624065|O2|Outcome|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
456584|NCT00624065|O1|Outcome|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
456585|NCT00624065|O2|Outcome|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
456586|NCT00624065|O1|Outcome|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
456587|NCT00624065|E2|Reported Event|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
456588|NCT00624065|E1|Reported Event|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
456589|NCT00624195|B3|Baseline|Total|Total of all reporting groups
456590|NCT00624195|B2|Baseline|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
456591|NCT00624195|B1|Baseline|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
456592|NCT00624195|P2|Participant Flow|Non-CNS-targeted|"Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
456593|NCT00624195|P1|Participant Flow|CNS-targeted|"CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, under dosing).
Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
456594|NCT00624195|O2|Outcome|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
456595|NCT00624195|O1|Outcome|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
456596|NCT00624195|E2|Reported Event|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
456597|NCT00624195|E1|Reported Event|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
456598|NCT00624221|B3|Baseline|Total|Total of all reporting groups
456599|NCT00624221|B2|Baseline|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
456600|NCT00624221|B1|Baseline|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
456601|NCT00624221|P2|Participant Flow|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
456602|NCT00624221|P1|Participant Flow|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
456603|NCT00624221|O2|Outcome|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
456604|NCT00624221|O1|Outcome|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
456605|NCT00624221|E2|Reported Event|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
456606|NCT00624221|E1|Reported Event|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
456607|NCT00624234|B7|Baseline|Total|Total of all reporting groups
456608|NCT00624234|B6|Baseline|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
456609|NCT00624234|B5|Baseline|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II
Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
456610|NCT00624234|B4|Baseline|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I
Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
456611|NCT00624234|B3|Baseline|Typically Developing Readers|Control group--children who do not have reading problems
456714|NCT00624442|E6|Reported Event|Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
456612|NCT00624234|B2|Baseline|NF-Tutoring Program 2|"Tutoring Program II
Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
456613|NCT00624234|B1|Baseline|NF-Tutoring Program 1|"Tutoring Program I
Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
456614|NCT00624234|P6|Participant Flow|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
456615|NCT00624234|P5|Participant Flow|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II
Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
456616|NCT00624234|P4|Participant Flow|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I
Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
456617|NCT00624234|P3|Participant Flow|Typically Developing Readers|Control group--children who do not have reading problems
456618|NCT00624234|P2|Participant Flow|NF-Tutoring Program 2|"Tutoring Program II
Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
456619|NCT00624234|P1|Participant Flow|NF-Tutoring Program 1|"Tutoring Program I
Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
456620|NCT00624234|O6|Outcome|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
456621|NCT00624234|O5|Outcome|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II
Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
456667|NCT00624338|E1|Reported Event|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456622|NCT00624234|O4|Outcome|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I
Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
456623|NCT00624234|O3|Outcome|Typically Developing Readers|Control group--children who do not have reading problems
456624|NCT00624234|O2|Outcome|NF-Tutoring Program 2|"Tutoring Program II
Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
456625|NCT00624234|O1|Outcome|NF-Tutoring Program 1|"Tutoring Program I
Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
456626|NCT00624234|E6|Reported Event|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
456627|NCT00624234|E5|Reported Event|IRD-Tutoring Program 2|These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.
456628|NCT00624234|E4|Reported Event|IRD-Tutoring Program 1|These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.
456629|NCT00624234|E3|Reported Event|Typically Developing Readers|Control group--children who do not have reading problems
456630|NCT00624234|E2|Reported Event|NF-Tutoring Program 2|"Tutoring Program II
Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
456631|NCT00624234|E1|Reported Event|NF-Tutoring Program 1|"Tutoring Program I
Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
456632|NCT00624286|B3|Baseline|Total|Total of all reporting groups
456633|NCT00624286|B2|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
456634|NCT00624286|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
456635|NCT00624286|P2|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
456636|NCT00624286|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
456637|NCT00624286|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
456638|NCT00624286|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
456639|NCT00624286|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
456640|NCT00624286|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
456641|NCT00624286|E2|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
456642|NCT00624286|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
456643|NCT00624338|B4|Baseline|Total|Total of all reporting groups
456644|NCT00624338|B3|Baseline|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456645|NCT00624338|B2|Baseline|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456646|NCT00624338|B1|Baseline|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456647|NCT00624338|P3|Participant Flow|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456648|NCT00624338|P2|Participant Flow|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456649|NCT00624338|P1|Participant Flow|Atacicept 75 mg|75 milligram (mg) atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456650|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456651|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456652|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456653|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456654|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456655|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456656|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456657|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456658|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456659|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456660|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456661|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456662|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456663|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456664|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456665|NCT00624338|E3|Reported Event|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456666|NCT00624338|E2|Reported Event|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
456668|NCT00624377|B1|Baseline|Spiriva 18µg With HandiHaler Device on COPD Patients|
456669|NCT00624377|P1|Participant Flow|Spiriva 18µg With HandiHaler Device on COPD Patients|
456670|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
456671|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
456672|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
456673|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
456674|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
456675|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
456676|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
456677|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
456678|NCT00624377|E1|Reported Event|Spiriva 18µg With HandiHaler Device on COPD Patients|
456679|NCT00624416|B1|Baseline|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
456680|NCT00624416|P1|Participant Flow|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
456681|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
456713|NCT00624442|E7|Reported Event|Cohort 2, Loading Dose of 2.2 mg/kg/hr|Loading dose is first hour of IV infusion. This dose level occurred in 1 patient due to accidental overdose.
456682|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
456683|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
456684|NCT00624416|E1|Reported Event|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
456685|NCT00624442|B6|Baseline|Total|Total of all reporting groups
456686|NCT00624442|B5|Baseline|Cohort 5|2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
456687|NCT00624442|B4|Baseline|Cohort 4|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
456688|NCT00624442|B3|Baseline|Cohort 3|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
456689|NCT00624442|B2|Baseline|Cohort 2|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
456690|NCT00624442|B1|Baseline|Cohort 1|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
456691|NCT00624442|P5|Participant Flow|Cohort 5|2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
456692|NCT00624442|P4|Participant Flow|Cohort 4|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
456693|NCT00624442|P3|Participant Flow|Cohort 3|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
456694|NCT00624442|P2|Participant Flow|Cohort 2|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
456695|NCT00624442|P1|Participant Flow|Cohort 1|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
456696|NCT00624442|O6|Outcome|>500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
456697|NCT00624442|O5|Outcome|>400-500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
456698|NCT00624442|O4|Outcome|>300-400 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
456699|NCT00624442|O3|Outcome|>200-300 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
456700|NCT00624442|O2|Outcome|>100-200 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
456701|NCT00624442|O1|Outcome|>0-100 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
457086|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
456702|NCT00624442|O6|Outcome|>500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
456703|NCT00624442|O5|Outcome|>400-500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
456704|NCT00624442|O4|Outcome|>300-400 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
456705|NCT00624442|O3|Outcome|>200-300 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
456706|NCT00624442|O2|Outcome|>100-200 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
456707|NCT00624442|O1|Outcome|>0-100 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
456708|NCT00624442|E12|Reported Event|Cohort 5, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
456709|NCT00624442|E11|Reported Event|Cohort 5, Loading Dose of 0.75 mg/kg/hr|Loading dose is first hour of IV infusion.
456710|NCT00624442|E10|Reported Event|Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
456711|NCT00624442|E9|Reported Event|Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr|Loading dose is first hour of IV infusion.
456712|NCT00624442|E8|Reported Event|Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr|Loading dose is first hour of IV infusion.
456715|NCT00624442|E5|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr|Loading dose is the first hour of IV infusion.
456716|NCT00624442|E4|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr|Loading dose is the first hour of IV infusion.
456717|NCT00624442|E3|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr|Loading dose is the first hour of IV infusion.
456718|NCT00624442|E2|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr|Loading dose is the first hour of IV infusion.
456719|NCT00624442|E1|Reported Event|Placebo|
456720|NCT00624468|B3|Baseline|Total|Total of all reporting groups
456721|NCT00624468|B2|Baseline|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456722|NCT00624468|B1|Baseline|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456723|NCT00624468|P4|Participant Flow|Atacicept: SFU Period|Subjects who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
456724|NCT00624468|P3|Participant Flow|Placebo: SFU Period|Subjects who received placebo matched to atacicept in double-blind period were included in safety follow-up (SFU) period (60 weeks) following premature termination of the trial.
456725|NCT00624468|P2|Participant Flow|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456726|NCT00624468|P1|Participant Flow|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456727|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456728|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456729|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456730|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456731|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456732|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456733|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456734|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456735|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456736|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456737|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456738|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
457087|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
456739|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456740|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456741|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456742|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456743|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456744|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456745|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456746|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456747|NCT00624468|E4|Reported Event|Atacicept: SFU Period|Participants who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
456748|NCT00624468|E3|Reported Event|Placebo: SFU Period|Participants who received placebo matched to atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
456749|NCT00624468|E2|Reported Event|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
456750|NCT00624468|E1|Reported Event|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
456751|NCT00624520|B3|Baseline|Total|Total of all reporting groups
456752|NCT00624520|B2|Baseline|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456753|NCT00624520|B1|Baseline|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456754|NCT00624520|P2|Participant Flow|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456755|NCT00624520|P1|Participant Flow|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456756|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456757|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456758|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456759|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456760|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456761|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456762|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456763|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456764|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456765|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456766|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456767|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456768|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456769|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456770|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456771|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456772|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456773|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456774|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456775|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456776|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
457100|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
456777|NCT00624520|E2|Reported Event|Patient Education|"10 week program of once weekly Patient Education group sessions
Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
456778|NCT00624520|E1|Reported Event|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
456779|NCT00624559|B5|Baseline|Total|Total of all reporting groups
456780|NCT00624559|B4|Baseline|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
456781|NCT00624559|B3|Baseline|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
456782|NCT00624559|B2|Baseline|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
456783|NCT00624559|B1|Baseline|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
456784|NCT00624559|P4|Participant Flow|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
456785|NCT00624559|P3|Participant Flow|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
456786|NCT00624559|P2|Participant Flow|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
456787|NCT00624559|P1|Participant Flow|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
456788|NCT00624559|O4|Outcome|Placebo, High Sodium Diet|Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet
456789|NCT00624559|O3|Outcome|Placebo, Low Sodium Diet|Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor
456790|NCT00624559|O2|Outcome|Celebrex, High Sodium Diet|Result taken on last day of a 7 day high salt diet
456791|NCT00624559|O1|Outcome|Celebrex, Low Sodium Diet|Result taken at the end of 7 day low sodium diet
456792|NCT00624559|O4|Outcome|Placebo, High Sodium Diet|Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet
456793|NCT00624559|O3|Outcome|Placebo, Low Sodium Diet|Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor
456794|NCT00624559|O2|Outcome|Celebrex, High Sodium Diet|Result taken on last day of a 7 day high salt diet
456795|NCT00624559|O1|Outcome|Celebrex, Low Sodium Diet|Result taken at the end of 7 day low sodium diet
456796|NCT00624559|E4|Reported Event|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
456797|NCT00624559|E3|Reported Event|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
456798|NCT00624559|E2|Reported Event|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
456799|NCT00624559|E1|Reported Event|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
456800|NCT00624585|B1|Baseline|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
457017|NCT00624832|B1|Baseline|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
457463|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
456801|NCT00624585|P1|Participant Flow|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
456802|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
456803|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
457055|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
456804|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
456805|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
456806|NCT00624585|E1|Reported Event|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
456807|NCT00624780|B7|Baseline|Total|Total of all reporting groups
456808|NCT00624780|B6|Baseline|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456809|NCT00624780|B5|Baseline|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456810|NCT00624780|B4|Baseline|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456811|NCT00624780|B3|Baseline|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456812|NCT00624780|B2|Baseline|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456813|NCT00624780|B1|Baseline|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456814|NCT00624780|P6|Participant Flow|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456815|NCT00624780|P5|Participant Flow|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456816|NCT00624780|P4|Participant Flow|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456817|NCT00624780|P3|Participant Flow|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456818|NCT00624780|P2|Participant Flow|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456827|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
457044|NCT00625131|E2|Reported Event|Placebo Patch Group|"Transdermal placebo patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
457088|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
456819|NCT00624780|P1|Participant Flow|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456820|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456821|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456822|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456823|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456824|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456825|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456826|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
457045|NCT00625131|E1|Reported Event|Active Nicotine Patch Group|"Transdermal nicotine patch
Nicotine: Delivered through transdermal nicotine patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
456828|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456829|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
457019|NCT00624832|P3|Participant Flow|Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
456830|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456831|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456832|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456833|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456834|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456835|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456836|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456837|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456838|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456839|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456840|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456841|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456842|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456843|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456844|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456845|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456846|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456847|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456848|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456849|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456850|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456851|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456852|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456853|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456854|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456855|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456856|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456857|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456858|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456859|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456860|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456861|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456862|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456863|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456864|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456865|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456866|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456867|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456868|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456869|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456870|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456871|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456872|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456873|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456874|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456875|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456876|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456877|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456878|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456879|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456880|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456881|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456882|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456883|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
457020|NCT00624832|P2|Participant Flow|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
457271|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
456884|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456885|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456886|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456887|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456888|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456889|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456890|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
457046|NCT00625183|B1|Baseline|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
456891|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
457021|NCT00624832|P1|Participant Flow|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
457272|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
456892|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456893|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456894|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456895|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456896|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456897|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456898|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456899|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456900|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456901|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
457053|NCT00625365|B1|Baseline|DEFINITY (Perflutren Lipid Microsphere)|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
456902|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456903|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456904|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456905|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456906|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456907|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456908|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456909|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456910|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456920|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
457054|NCT00625365|P1|Participant Flow|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
456911|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456912|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456913|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456914|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456915|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456916|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456917|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456918|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456919|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
457047|NCT00625183|P1|Participant Flow|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
457273|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
456921|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456922|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456923|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456924|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456925|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456926|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456927|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456928|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456929|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456930|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456931|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456932|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456933|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456934|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456935|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456936|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456937|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456947|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456968|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456938|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456939|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456940|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456941|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456942|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456943|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456944|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456945|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456946|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456948|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456949|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456950|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456951|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456952|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456953|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456954|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456955|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456956|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
457084|NCT00625404|P1|Participant Flow|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
456957|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456958|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456959|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456960|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456961|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456962|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456963|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456964|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456965|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456966|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456967|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
457085|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
456969|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456970|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456971|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456972|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456973|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456974|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456975|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456985|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456986|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456976|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456977|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456978|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456979|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456980|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456981|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456982|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456983|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456984|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456987|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456988|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456989|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456990|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456991|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
456992|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456993|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
456994|NCT00624780|E6|Reported Event|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456995|NCT00624780|E5|Reported Event|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
457015|NCT00624832|B3|Baseline|Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
457016|NCT00624832|B2|Baseline|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
457018|NCT00624832|P4|Participant Flow|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
456996|NCT00624780|E4|Reported Event|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456997|NCT00624780|E3|Reported Event|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
456998|NCT00624780|E2|Reported Event|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
456999|NCT00624780|E1|Reported Event|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
457000|NCT00624806|B3|Baseline|Total|Total of all reporting groups
457001|NCT00624806|B2|Baseline|Weekly Group|"Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
457002|NCT00624806|B1|Baseline|Daily Group|"Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
457003|NCT00624806|P2|Participant Flow|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
457004|NCT00624806|P1|Participant Flow|Arm 1|"Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
457005|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
457006|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
457007|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
457008|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
457009|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
457010|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
457011|NCT00624806|E2|Reported Event|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
No adverse events reported."
457012|NCT00624806|E1|Reported Event|Arm 1|"Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
No adverse events reported."
457013|NCT00624832|B5|Baseline|Total|Total of all reporting groups
457014|NCT00624832|B4|Baseline|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
457022|NCT00624832|O3|Outcome|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
457023|NCT00624832|O2|Outcome|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
457024|NCT00624832|O1|Outcome|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
457025|NCT00624832|O3|Outcome|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
457026|NCT00624832|O2|Outcome|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
457027|NCT00624832|O1|Outcome|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
457028|NCT00624832|E4|Reported Event|Placebo Comparator|Placebo comparator
457029|NCT00624832|E3|Reported Event|Xolair (IgE= 301- 699 IU/mL)|Patients with screening IgE levels= 301- 699 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
457030|NCT00624832|E2|Reported Event|Xolair (IgE= 700- 2000 IU/mL)|Patients with screening IgE levels= 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
457031|NCT00624832|E1|Reported Event|Xolair (IgE= 30- 300 IU/mL)|Patients with screening IgE levels= 30-300 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
457032|NCT00625131|B3|Baseline|Total|Total of all reporting groups
457033|NCT00625131|B2|Baseline|Arm 2|"Transdermal placebo patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
457034|NCT00625131|B1|Baseline|Arm 1|"Transdermal nicotine patch
Nicotine: Delivered through transdermal nicotine patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
457035|NCT00625131|P3|Participant Flow|Not Randomized|This arm includes patients who met screening criteria for entry into the randomization, but withdrew prior to randomization.
457036|NCT00625131|P2|Participant Flow|Placebo Patch Group|"Transdermal placebo patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
457037|NCT00625131|P1|Participant Flow|Active Nicotine Patch Group|"Transdermal nicotine patch
Nicotine: Delivered through transdermal nicotine patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
457038|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
457039|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch
Nicotine: Delivered through transdermal nicotine patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
457040|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
457041|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch
Nicotine: Delivered through transdermal nicotine patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
457042|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
457043|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch
Nicotine: Delivered through transdermal nicotine patch
Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation
Bupropion SR: Antidepressant"
457048|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
457049|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
457050|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
457051|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
457052|NCT00625183|E1|Reported Event|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
457056|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
457057|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
457058|NCT00625365|E1|Reported Event|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
457059|NCT00625391|B5|Baseline|Total|Total of all reporting groups
457060|NCT00625391|B4|Baseline|GTP+Tai Chi|GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
457061|NCT00625391|B3|Baseline|Placebo+Tai Chi|Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
457062|NCT00625391|B2|Baseline|Green Tea Polyphenols (GTP)|Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
457063|NCT00625391|B1|Baseline|Placebo|Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
457064|NCT00625391|P4|Participant Flow|GTP + Tai Chi Group|GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
457065|NCT00625391|P3|Participant Flow|Placebo + Tai Chi Group|Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
457066|NCT00625391|P2|Participant Flow|Green Tea Polyphenols (GTP) Group|Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
457067|NCT00625391|P1|Participant Flow|Placebo Group|Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
457068|NCT00625391|O4|Outcome|Green Tea Polyphenol + Tai Chi|GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
457069|NCT00625391|O3|Outcome|Placebo + Tai Chi|Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
457070|NCT00625391|O2|Outcome|Green Tea Polyphenols|GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
457071|NCT00625391|O1|Outcome|Placebo|"Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks."
457072|NCT00625391|O4|Outcome|Green Tea Polyphenol + Tai Chi|GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
457073|NCT00625391|O3|Outcome|Placebo + Tai Chi|Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
457074|NCT00625391|O2|Outcome|Green Tea Polyphenols|GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
457075|NCT00625391|O1|Outcome|Placebo|"Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks."
457076|NCT00625391|E4|Reported Event|GTP+TC|Green tea polyphenols at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks
457077|NCT00625391|E3|Reported Event|Placebo+Tai Chi (TC)|Medicinal starch at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks
457078|NCT00625391|E2|Reported Event|Green Tea Polyphenols (GTP)|Green tea polyphenols at 500 mg daily for 24 weeks
457079|NCT00625391|E1|Reported Event|Placebo|Medicinal starch at 500 mg daily for 24 weeks
457080|NCT00625404|B3|Baseline|Total|Total of all reporting groups
457081|NCT00625404|B2|Baseline|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457082|NCT00625404|B1|Baseline|Truvada Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457083|NCT00625404|P2|Participant Flow|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457089|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457090|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
457091|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457092|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
457093|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457094|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
457095|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457096|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
457097|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457098|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
457099|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457101|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457102|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
457103|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457104|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
457105|NCT00625404|O2|Outcome|Placebo Arm|The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
457106|NCT00625404|O1|Outcome|Truvada Arm|The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
457107|NCT00625404|E2|Reported Event|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
457108|NCT00625404|E1|Reported Event|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
457109|NCT00625586|B1|Baseline|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
457110|NCT00625586|P1|Participant Flow|RAV12 Plus Gemcitabine|RAV12 monoclonal antibody plus gemcitabine
457111|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
457112|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
457113|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
457114|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
457115|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
457116|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
457117|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
457118|NCT00625586|E1|Reported Event|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
457119|NCT00625729|B1|Baseline|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
457219|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457120|NCT00625729|P1|Participant Flow|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
457121|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
457122|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
457123|NCT00625729|O1|Outcome|Responder Patients|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with donor natural killer cells infusion, rituximab, aldesleukin and chemotherapy who had a response to treatment (clinical response or partial response).
457124|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
457125|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
457126|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
457229|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457127|NCT00625729|E1|Reported Event|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
457128|NCT00625742|B1|Baseline|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
457129|NCT00625742|P1|Participant Flow|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
457130|NCT00625742|O1|Outcome|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
457131|NCT00625742|O1|Outcome|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
457132|NCT00625742|E1|Reported Event|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
457133|NCT00625820|B1|Baseline|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks
Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
457134|NCT00625820|P1|Participant Flow|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks
Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
457135|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks
Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
457136|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks
Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
457137|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|
457138|NCT00625820|E1|Reported Event|BH4, BH4 + Vit C|
457139|NCT00607919|B3|Baseline|Total|Total of all reporting groups
457140|NCT00607919|B2|Baseline|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457141|NCT00607919|B1|Baseline|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457142|NCT00607919|P2|Participant Flow|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457143|NCT00607919|P1|Participant Flow|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase
Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457220|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457144|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457145|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457146|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457147|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457230|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457231|NCT00607997|O5|Outcome|Total|Schedule A, B and C combined
457148|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457149|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457150|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457151|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457152|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457153|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457154|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457155|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457156|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457157|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457158|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457159|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457302|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457160|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457161|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457162|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457163|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457164|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457165|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457166|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457167|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457168|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457169|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457170|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457171|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457172|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457173|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457174|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457175|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457176|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457177|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457178|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457179|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457180|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457181|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457182|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457183|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457184|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457185|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457186|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457187|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457188|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457189|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457190|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457191|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457192|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457193|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457194|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457195|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457196|NCT00607919|E2|Reported Event|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.
Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
457197|NCT00607919|E1|Reported Event|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with atomoxetine"
457198|NCT00607997|B5|Baseline|Total|Total of all reporting groups
457199|NCT00607997|B4|Baseline|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457200|NCT00607997|B3|Baseline|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457201|NCT00607997|B2|Baseline|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457202|NCT00607997|B1|Baseline|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457203|NCT00607997|P4|Participant Flow|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457204|NCT00607997|P3|Participant Flow|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457205|NCT00607997|P2|Participant Flow|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457206|NCT00607997|P1|Participant Flow|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457207|NCT00607997|O2|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457208|NCT00607997|O1|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457209|NCT00607997|O2|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457210|NCT00607997|O1|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457211|NCT00607997|O2|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457212|NCT00607997|O1|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457213|NCT00607997|O2|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457214|NCT00607997|O1|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457215|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457216|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457217|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457218|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457221|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457222|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457223|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457224|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457225|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457226|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457227|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457228|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457232|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457233|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457234|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457235|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457236|NCT00607997|O2|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457237|NCT00607997|O1|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457238|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457239|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457240|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457241|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457242|NCT00607997|O5|Outcome|Total|Schedule A, B, and C combined
457243|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457244|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457245|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457246|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457247|NCT00607997|O5|Outcome|Total|Schedule A, B and C combined
457248|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457249|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457250|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457251|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457252|NCT00607997|O5|Outcome|Total|Schedule A, B and C combined
457253|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457254|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457255|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457460|NCT00619476|P3|Participant Flow|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457256|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457257|NCT00607997|E4|Reported Event|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
457258|NCT00607997|E3|Reported Event|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
457259|NCT00607997|E2|Reported Event|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
457260|NCT00607997|E1|Reported Event|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
457261|NCT00608023|B4|Baseline|Total|Total of all reporting groups
457262|NCT00608023|B3|Baseline|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
457263|NCT00608023|B2|Baseline|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
457264|NCT00608023|B1|Baseline|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
457265|NCT00608023|P3|Participant Flow|Placebo-Tesamorelin (P-T)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
457266|NCT00608023|P2|Participant Flow|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
457267|NCT00608023|P1|Participant Flow|Tesamorelin (52 Weeks)|Tesamorelin 2 mg/day for 52 Weeks
457268|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
457269|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
457270|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
457274|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
457275|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
457276|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
457277|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks.
457278|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks.
457279|NCT00608023|O1|Outcome|Tesamorelin (52 Weeks)|Tesamorelin 2 mg/day for 52 weeks
457280|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
457281|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
457282|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
457283|NCT00608023|E3|Reported Event|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
457284|NCT00608023|E2|Reported Event|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
457285|NCT00608023|E1|Reported Event|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
457286|NCT00608140|B3|Baseline|Total|Total of all reporting groups
457287|NCT00608140|B2|Baseline|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
457288|NCT00608140|B1|Baseline|1 Medical Therapy Plus Surgical Repair|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
457289|NCT00608140|P2|Participant Flow|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
457290|NCT00608140|P1|Participant Flow|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
457291|NCT00608140|O2|Outcome|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
457292|NCT00608140|O1|Outcome|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
457293|NCT00608140|O2|Outcome|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
457294|NCT00608140|O1|Outcome|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
457295|NCT00608140|E2|Reported Event|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
457296|NCT00608140|E1|Reported Event|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
457297|NCT00608205|B3|Baseline|Total|Total of all reporting groups
457298|NCT00608205|B2|Baseline|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457299|NCT00608205|B1|Baseline|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457300|NCT00608205|P2|Participant Flow|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457301|NCT00608205|P1|Participant Flow|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457303|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457304|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457305|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457306|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457307|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457308|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457309|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457310|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457311|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457312|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457313|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457314|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457315|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457316|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457317|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457318|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457319|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457320|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457321|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457322|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457323|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457324|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457325|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457326|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457327|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457328|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457329|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457330|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457331|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457332|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457333|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457334|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457335|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457336|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457337|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457338|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457339|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457340|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457341|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457342|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457343|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457344|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457345|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457346|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457347|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457348|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457349|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457350|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457351|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457352|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457353|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457354|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457355|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457356|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457357|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457358|NCT00608205|O2|Outcome|Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457359|NCT00608205|O1|Outcome|Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457360|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457361|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457362|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457363|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457364|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457365|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457366|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457367|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457368|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457369|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457370|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457371|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457372|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457373|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457374|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457375|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457376|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457377|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457378|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457379|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457380|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457381|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457382|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457383|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457384|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457385|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457386|NCT00608205|E2|Reported Event|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
457387|NCT00608205|E1|Reported Event|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
457388|NCT00608244|B1|Baseline|LCP-Tacro|Evaluation of steady state tacrolimus exposure (AUC0-24) and trough levels (C24) in stable liver transplant recipients converted from Prograf to LCP-Tacro in a 3-sequence study design and validate the dose conversion ratio determined in the Phase 1 program.
457389|NCT00608244|P1|Participant Flow|LCP-Tacro|"All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15.
On Day 22, patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days.
LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL."
457390|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
457391|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
457392|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
457393|NCT00608244|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
457394|NCT00608244|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
457395|NCT00608244|E2|Reported Event|Prograf|"Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
59 patients were enrolled into the study and all 59 were dosed with Prograf. Adverse Events occurring during the follow up period (Days 22-51) have been counted in the Prograf treatment arm as patients were on Prograf during this period."
457396|NCT00608244|E1|Reported Event|LCP-Tacro|"LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
59 patients were enrolled into the study and all 59 were dosed with LCP-Tacro."
457397|NCT00608322|B3|Baseline|Total|Total of all reporting groups
457398|NCT00608322|B2|Baseline|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
457399|NCT00608322|B1|Baseline|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
457400|NCT00608322|P2|Participant Flow|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
457401|NCT00608322|P1|Participant Flow|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
457402|NCT00608322|O2|Outcome|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
457403|NCT00608322|O1|Outcome|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
457404|NCT00608322|E2|Reported Event|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
457405|NCT00608322|E1|Reported Event|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
457406|NCT00619307|B3|Baseline|Total|Total of all reporting groups
457407|NCT00619307|B2|Baseline|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
457461|NCT00619476|P2|Participant Flow|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457408|NCT00619307|B1|Baseline|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
457409|NCT00619307|P2|Participant Flow|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
457410|NCT00619307|P1|Participant Flow|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
457411|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
457412|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
457413|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
457414|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
457415|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
457416|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
457417|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
457418|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
457419|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
457420|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
457462|NCT00619476|P1|Participant Flow|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457421|NCT00619307|E2|Reported Event|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
457422|NCT00619307|E1|Reported Event|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
457423|NCT00619359|B3|Baseline|Total|Total of all reporting groups
457424|NCT00619359|B2|Baseline|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
457425|NCT00619359|B1|Baseline|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
457426|NCT00619359|P2|Participant Flow|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
457427|NCT00619359|P1|Participant Flow|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
457428|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
457429|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
457430|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
457431|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
457432|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
457433|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
457434|NCT00619359|E2|Reported Event|Aprepitant|"Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
6 patients from the aprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables."
457435|NCT00619359|E1|Reported Event|Fosaprepitant|"Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
4 patients from the fosaprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables."
457436|NCT00619385|B4|Baseline|Total|Total of all reporting groups
457437|NCT00619385|B3|Baseline|Proellex 200 mg|"Proellex 200 mg daily for 7 days
Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
457438|NCT00619385|B2|Baseline|Proellex 150 mg|"Proellex 150 mg daily for 7 days
Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
457439|NCT00619385|B1|Baseline|Proellex 100 mg|"Proellex 100 mg daily for 7 days
Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
457440|NCT00619385|P3|Participant Flow|Proellex 200 mg|Proellex 200 mg daily for 7 days
457441|NCT00619385|P2|Participant Flow|Proellex 150 mg|Proellex 150 mg daily for 7 days
457442|NCT00619385|P1|Participant Flow|Proellex 100 mg|Proellex 100 mg daily for 7 days
457443|NCT00619385|O4|Outcome|Proellex 200 mg Vials|Proellex 200 mg vials daily for 7 days
457444|NCT00619385|O3|Outcome|Proellex 200 mg Caps|Proellex 200 mg capsules daily for 7 days
457445|NCT00619385|O2|Outcome|Proellex 150 mg|Proellex 150 mg daily for 7 days
457446|NCT00619385|O1|Outcome|Proellex 100 mg|Proellex 100 mg daily for 7 days
457447|NCT00619385|O4|Outcome|Proellex 200 mg Vials|Proellex 200 mg daily for 7 days vials
457448|NCT00619385|O3|Outcome|Proellex 200 mg Caps|Proellex 200 mg daily for 7 days capsules
457449|NCT00619385|O2|Outcome|Proellex 150 mg|Proellex 150 mg daily for 7 days
457450|NCT00619385|O1|Outcome|Proellex 100 mg|Proellex 100 mg daily for 7 days
457451|NCT00619385|E3|Reported Event|Proellex 200 mg|Proellex 200 mg daily for 7 days
457452|NCT00619385|E2|Reported Event|Proellex 150 mg|Proellex 150 mg daily for 7 days
457453|NCT00619385|E1|Reported Event|Proellex 100 mg|Proellex 100 mg daily for 7 days
457454|NCT00619476|B5|Baseline|Total|Total of all reporting groups
457455|NCT00619476|B4|Baseline|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457456|NCT00619476|B3|Baseline|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457457|NCT00619476|B2|Baseline|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457458|NCT00619476|B1|Baseline|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457459|NCT00619476|P4|Participant Flow|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457464|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457465|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457466|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457467|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457468|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457469|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457470|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457471|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457472|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457473|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457474|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457475|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457476|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457477|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457478|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457479|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457480|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457481|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457482|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457483|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457484|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457485|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457486|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457487|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457488|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457489|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457490|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457491|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457492|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457493|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457494|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457495|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457496|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457497|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457498|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457499|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457500|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457501|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457502|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457503|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457504|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457505|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457506|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457507|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457508|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457509|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457510|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457511|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457512|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457513|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457514|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457515|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457516|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457517|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457518|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457519|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457520|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457521|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457522|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457523|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457524|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457525|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457526|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457527|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457528|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457529|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457530|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457531|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457532|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457533|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457534|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457535|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457536|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457537|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457538|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457539|NCT00619476|E4|Reported Event|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
457540|NCT00619476|E3|Reported Event|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
457541|NCT00619476|E2|Reported Event|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
457542|NCT00619476|E1|Reported Event|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
457543|NCT00619489|B3|Baseline|Total|Total of all reporting groups
457544|NCT00619489|B2|Baseline|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457545|NCT00619489|B1|Baseline|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457546|NCT00619489|P2|Participant Flow|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457547|NCT00619489|P1|Participant Flow|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457548|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457549|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457550|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457551|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457552|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457553|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457554|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457555|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457556|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457557|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457558|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457559|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457560|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457561|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457562|NCT00619489|E2|Reported Event|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457563|NCT00619489|E1|Reported Event|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
457564|NCT00619502|B3|Baseline|Total|Total of all reporting groups
457565|NCT00619502|B2|Baseline|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
457566|NCT00619502|B1|Baseline|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
457567|NCT00619502|P2|Participant Flow|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
457568|NCT00619502|P1|Participant Flow|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
457569|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
457570|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP-T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
457571|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
457572|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
457573|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
457574|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
457575|NCT00619502|E2|Reported Event|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
457576|NCT00619502|E1|Reported Event|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
457577|NCT00619619|B9|Baseline|Total|Total of all reporting groups
457578|NCT00619619|B8|Baseline|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457579|NCT00619619|B7|Baseline|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457580|NCT00619619|B6|Baseline|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457581|NCT00619619|B5|Baseline|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457582|NCT00619619|B4|Baseline|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457583|NCT00619619|B3|Baseline|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457584|NCT00619619|B2|Baseline|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457585|NCT00619619|B1|Baseline|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457586|NCT00619619|P8|Participant Flow|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457587|NCT00619619|P7|Participant Flow|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457588|NCT00619619|P6|Participant Flow|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457589|NCT00619619|P5|Participant Flow|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457590|NCT00619619|P4|Participant Flow|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457919|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye.
457591|NCT00619619|P3|Participant Flow|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457592|NCT00619619|P2|Participant Flow|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457593|NCT00619619|P1|Participant Flow|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457594|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457595|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457596|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457597|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457598|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457599|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457600|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457601|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457602|NCT00619619|O1|Outcome|Desvenlafaxine - Combined Children and Adolescent Cohorts|Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels and Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
457603|NCT00619619|O2|Outcome|Desvenlafaxine – Combined Adolescent Cohorts|Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
457604|NCT00619619|O1|Outcome|Desvenlafaxine – Combined Children Cohorts|Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels.
457605|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457606|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457607|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457608|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457609|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457610|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457611|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457612|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457613|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457614|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457615|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457616|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457617|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457700|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457618|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457619|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457620|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457621|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457622|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457623|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457624|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457625|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457626|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457627|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457628|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457629|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457630|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457631|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457632|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457633|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457634|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457635|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457636|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457637|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457638|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457639|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457640|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457641|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457642|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457643|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457644|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457645|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457646|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457647|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457648|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457649|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457650|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457651|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457652|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457653|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457654|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457655|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457656|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457657|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457658|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457659|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457660|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457661|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457662|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457663|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457664|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457665|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457666|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457667|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457668|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457669|NCT00619619|E8|Reported Event|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
457670|NCT00619619|E7|Reported Event|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457671|NCT00619619|E6|Reported Event|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457672|NCT00619619|E5|Reported Event|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457673|NCT00619619|E4|Reported Event|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
457674|NCT00619619|E3|Reported Event|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
457675|NCT00619619|E2|Reported Event|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
457676|NCT00619619|E1|Reported Event|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
457677|NCT00619645|B1|Baseline|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
457678|NCT00619645|P1|Participant Flow|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
457679|NCT00619645|O1|Outcome|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
457680|NCT00619645|O1|Outcome|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
457681|NCT00619645|O1|Outcome|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
457682|NCT00619645|E1|Reported Event|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation"
457683|NCT00619684|B1|Baseline|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given PO"
457684|NCT00619684|P1|Participant Flow|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given PO"
457685|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given PO"
457686|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given PO"
457687|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given PO"
457688|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given PO"
457689|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given PO"
457690|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given PO"
457691|NCT00619684|E1|Reported Event|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given PO"
457692|NCT00625872|B3|Baseline|Total|Total of all reporting groups
457693|NCT00625872|B2|Baseline|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457694|NCT00625872|B1|Baseline|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457695|NCT00625872|P2|Participant Flow|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457696|NCT00625872|P1|Participant Flow|Somatropin|Somatropin 0.035 milligram/kilogram/day (mg/kg/day) was administered subcutaneously (s.c) according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457697|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457698|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457699|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457701|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457702|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457703|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457704|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457705|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457706|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457707|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457708|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457709|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457710|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457711|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457712|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457713|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457714|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457715|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457716|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457717|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457718|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457719|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457720|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457721|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
458424|NCT00631189|E2|Reported Event|Atorvastatin|Atorvastatin 10 mg
457722|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457723|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457724|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457725|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457726|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457727|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457728|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457729|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457730|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457731|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457732|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457733|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457734|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457735|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457736|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457737|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457738|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457739|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457740|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457741|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457742|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457743|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457744|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457745|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457746|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457747|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457748|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457749|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457750|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457751|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457752|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457753|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457754|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
460103|NCT00634270|B3|Baseline|Total|Total of all reporting groups
457755|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457756|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457757|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457758|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457759|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457760|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457761|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457762|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457763|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457764|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457765|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457766|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457767|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457768|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457769|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457770|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457771|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457772|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457773|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457774|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457775|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457776|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457777|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457778|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457779|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457780|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457781|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457782|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457783|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457784|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457785|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457786|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457787|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
461260|NCT00628862|E3|Reported Event|Placebo|Placebo
457788|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457789|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457790|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457791|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457792|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457793|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457794|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457795|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457796|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457797|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457798|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457799|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457800|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457801|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457802|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457803|NCT00625872|E2|Reported Event|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
457804|NCT00625872|E1|Reported Event|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
457805|NCT00625989|B1|Baseline|Mild Asthmatics|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
457806|NCT00625989|P2|Participant Flow|Allergen Then Diluent Challenge|"Subjects were screened, then given a 2 week washout period.
Samples collected on day 1 according to protocol. Day 2 allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol.
Two week wash out period.
Samples collected on day 1, after washout, according to protocol. Day 2, after washout, dilluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol."
457807|NCT00625989|P1|Participant Flow|Diluent Then Allergen Challenge|"Subjects were screened, then given a 2 week washout period.
Samples collected on day 1 according to protocol. Day 2 diluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol.
Two week wash out period.
Samples collected on day 1, after washout, according to protocol. Day 2, after washout, allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol."
457808|NCT00625989|O2|Outcome|Allergen|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
457809|NCT00625989|O1|Outcome|Diluent|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
457810|NCT00625989|O2|Outcome|Allergen|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
457811|NCT00625989|O1|Outcome|Diluent|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
457812|NCT00625989|E1|Reported Event|Mild Asthmatics|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
457813|NCT00626028|B3|Baseline|Total|Total of all reporting groups
457814|NCT00626028|B2|Baseline|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
457815|NCT00626028|B1|Baseline|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
457816|NCT00626028|P2|Participant Flow|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
457817|NCT00626028|P1|Participant Flow|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
457818|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
457819|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
534425|NCT00815347|O2|Outcome|Bosentan|
457820|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
457821|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
457822|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
457823|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
457824|NCT00626028|E2|Reported Event|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
457825|NCT00626028|E1|Reported Event|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
457826|NCT00626093|B1|Baseline|Group 1|
457827|NCT00626093|P1|Participant Flow|Cardiac Resynchronization Therapy - Defibrillators (CRT-D)|All patients enrolled were indicated for a CRT-D.
457828|NCT00626093|O1|Outcome|CRT-D|
457829|NCT00626093|O1|Outcome|CRT-D|
457830|NCT00626093|E1|Reported Event|Group 1|
457831|NCT00629525|B1|Baseline|RAD001|RAD001 at a dose of 10 mg PO daily
457832|NCT00629525|P1|Participant Flow|RAD001|RAD001 at a dose of 10 mg PO daily
457833|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
457834|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
457835|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
457836|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
457837|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
457838|NCT00629525|E1|Reported Event|RAD001|RAD001 at a dose of 10 mg PO daily
457839|NCT00629707|B3|Baseline|Total|Total of all reporting groups
457840|NCT00629707|B2|Baseline|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
457841|NCT00629707|B1|Baseline|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
457842|NCT00629707|P2|Participant Flow|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
457843|NCT00629707|P1|Participant Flow|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
457844|NCT00629707|O2|Outcome|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
457845|NCT00629707|O1|Outcome|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
457846|NCT00629707|E2|Reported Event|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
457847|NCT00629707|E1|Reported Event|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
457848|NCT00629772|B3|Baseline|Total|Total of all reporting groups
457849|NCT00629772|B2|Baseline|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
457850|NCT00629772|B1|Baseline|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
457851|NCT00629772|P2|Participant Flow|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
457852|NCT00629772|P1|Participant Flow|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
457853|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
457854|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
457855|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
457856|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
457857|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
457858|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
457859|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
457860|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
457861|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
457862|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
457863|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
457864|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
457865|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
457903|NCT00630292|O1|Outcome|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
457866|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
457867|NCT00629772|E2|Reported Event|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
457868|NCT00629772|E1|Reported Event|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22 throughout the entire study.
457869|NCT00629850|B3|Baseline|Total|Total of all reporting groups
457870|NCT00629850|B2|Baseline|Control|This arm of the study will not receive the device.
457871|NCT00629850|B1|Baseline|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
457872|NCT00629850|P2|Participant Flow|Control|This arm of the study will not receive the device.
457873|NCT00629850|P1|Participant Flow|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
457874|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
457875|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
457876|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
457877|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
457878|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
457879|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
457880|NCT00629850|E2|Reported Event|Control|This arm of the study will not receive the device.
457881|NCT00629850|E1|Reported Event|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
457882|NCT00630058|B3|Baseline|Total|Total of all reporting groups
457918|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye.
457883|NCT00630058|B2|Baseline|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457884|NCT00630058|B1|Baseline|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457885|NCT00630058|P2|Participant Flow|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457886|NCT00630058|P1|Participant Flow|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457887|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457888|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457889|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457890|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457891|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457892|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457893|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457894|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457895|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457896|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457897|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457898|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457899|NCT00630058|E2|Reported Event|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457900|NCT00630058|E1|Reported Event|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
457901|NCT00630292|B1|Baseline|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
457902|NCT00630292|P1|Participant Flow|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
457956|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457904|NCT00630292|E1|Reported Event|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
457905|NCT00630305|B1|Baseline|All Subjects|All subjects who were enrolled, randomized, and assigned to a study arm.
457906|NCT00630305|P1|Participant Flow|Overall|subjects were randomized to a session (A, B, C and D) and then to one of four lens sequences. Each subject participated in every session.
457907|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received lotrafilcon B in their right eye and then received lotrafilcon B in their left eye.
457908|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
457909|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved lotrafilcon B in their right eye and then received senofilcon A in their left eye.
457910|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received lotrafilcon B in their left eye.
457911|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received lotrafilcon B in their right eye and then received lotrafilcon B in their left eye.
457912|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
457913|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved lotrafilcon B in their right eye and then received senofilcon A in their left eye.
457914|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received lotrafilcon B in their left eye.
457915|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye.
457916|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
457917|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye.
457920|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
457921|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye.
457922|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye.
457923|NCT00630305|E4|Reported Event|Session D|"Closed eye session, this session includes the following sequences only:
senofilcon A/ lotrafilcon B
lotrafilcon B / senofilcon A
senofilcon A/ senofilcon A
lotrafilcon B / lotrafilcon B"
457924|NCT00630305|E3|Reported Event|Session C|"Open eye session, this session includes the following sequences only:
senofilcon A/ lotrafilcon B
lotrafilcon B / senofilcon A
senofilcon A/ senofilcon A
lotrafilcon B / lotrafilcon B"
457925|NCT00630305|E2|Reported Event|Session B|"Closed eye session, this session includes the following sequences only:
senofilcon A/ alphafilcon A
alphafilcon A/ senofilcon A
senofilcon A/ senofilcon A
alphafilcon A/ alphafilcon A"
457926|NCT00630305|E1|Reported Event|Session A|"Open eye session, this session includes the following sequences only:
senofilcon A / alphafilcon A
alphafilcon A / senofilcon A
senofilcon A / senofilcon A
alphafilcon A / alphafilcon A"
457927|NCT00630331|B4|Baseline|Total|Total of all reporting groups
457928|NCT00630331|B3|Baseline|Placebo|One dose of phosphate buffered solution (PBS).
457929|NCT00630331|B2|Baseline|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457930|NCT00630331|B1|Baseline|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457931|NCT00630331|P3|Participant Flow|Placebo|One dose of phosphate buffered solution (PBS).
457932|NCT00630331|P2|Participant Flow|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457933|NCT00630331|P1|Participant Flow|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457934|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
457935|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457936|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457937|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
457938|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457939|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457940|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
457941|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457942|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457943|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
457944|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457945|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457946|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
457947|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457948|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457949|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
457950|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457951|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457952|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
457953|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457954|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457955|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
534426|NCT00815347|O1|Outcome|Placebo|
457957|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457958|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
457959|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457960|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457961|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
457962|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457963|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457964|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
457965|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457966|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457967|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
457968|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457969|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457970|NCT00630331|E3|Reported Event|Placebo|One dose of phosphate buffered solution (PBS).
457971|NCT00630331|E2|Reported Event|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
457972|NCT00630331|E1|Reported Event|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
457973|NCT00630344|B1|Baseline|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once daily
Bicalutamide: Taken orally once daily"
457997|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
457998|NCT00630487|O1|Outcome|Placebo|
457974|NCT00630344|P1|Participant Flow|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once daily
Bicalutamide: Taken orally once daily"
457975|NCT00630344|O1|Outcome|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once daily
Bicalutamide: Taken orally once daily"
457976|NCT00630344|E1|Reported Event|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once daily
Bicalutamide: Taken orally once daily"
457977|NCT00630396|B1|Baseline|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
457978|NCT00630396|P1|Participant Flow|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
457979|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
457980|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
457981|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
457982|NCT00630396|E1|Reported Event|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
457983|NCT00630409|B1|Baseline|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.
Gemcitabine: 800 mg IV day 1 and 8
Doxil: 24 mg/m2 every 21 days IV"
457984|NCT00630409|P1|Participant Flow|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.
Gemcitabine: 800 mg IV day 1 and 8
Doxil: 24 mg/m2 every 21 days IV"
457985|NCT00630409|O1|Outcome|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.
Gemcitabine: 800 mg IV day 1 and 8 + Doxil: 24 mg/m2 every 21 days IV"
457986|NCT00630409|O1|Outcome|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.
Gemcitabine: 800 mg IV day 1 and 8
Doxil: 24 mg/m2 every 21 days IV"
458026|NCT00630539|B4|Baseline|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
534427|NCT00815347|O2|Outcome|Bosentan|
457987|NCT00630409|E1|Reported Event|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.
Gemcitabine: 800 mg IV day 1 and 8
Doxil: 24 mg/m2 every 21 days IV"
457988|NCT00630487|B3|Baseline|Total|Total of all reporting groups
457989|NCT00630487|B2|Baseline|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
457990|NCT00630487|B1|Baseline|Placebo|
457991|NCT00630487|P2|Participant Flow|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
457992|NCT00630487|P1|Participant Flow|Placebo|
457993|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
457994|NCT00630487|O1|Outcome|Placebo|
457995|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
457996|NCT00630487|O1|Outcome|Placebo|
458042|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
457999|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458000|NCT00630487|O1|Outcome|Placebo|
458001|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458002|NCT00630487|O1|Outcome|Placebo|
458003|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458004|NCT00630487|O1|Outcome|Placebo|
458005|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458006|NCT00630487|O1|Outcome|Placebo|
458007|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458008|NCT00630487|O1|Outcome|Placebo|
458009|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458010|NCT00630487|O1|Outcome|Placebo|
458011|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458012|NCT00630487|O1|Outcome|Placebo|
458013|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458014|NCT00630487|O1|Outcome|Placebo|
458015|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458016|NCT00630487|O1|Outcome|Placebo|
458017|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458018|NCT00630487|O1|Outcome|Placebo|
458019|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458020|NCT00630487|O1|Outcome|Placebo|
458021|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458022|NCT00630487|O1|Outcome|Placebo|
458023|NCT00630487|E2|Reported Event|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
458024|NCT00630487|E1|Reported Event|Placebo|
458025|NCT00630539|B5|Baseline|Total|Total of all reporting groups
458421|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
458027|NCT00630539|B3|Baseline|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458028|NCT00630539|B2|Baseline|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458029|NCT00630539|B1|Baseline|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458030|NCT00630539|P4|Participant Flow|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458031|NCT00630539|P3|Participant Flow|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458032|NCT00630539|P2|Participant Flow|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458033|NCT00630539|P1|Participant Flow|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458034|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458035|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458036|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458037|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458038|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458039|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458040|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458041|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458043|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458044|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458045|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458046|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458047|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458048|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458049|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458050|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458051|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458052|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458053|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458054|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458055|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458056|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458057|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458058|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458059|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458060|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458061|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458062|NCT00630539|O8|Outcome|Subjects on Ospemifene 30 mg/Day (Week 12)|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458063|NCT00630539|O7|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458064|NCT00630539|O6|Outcome|Subjects on Ospemifine 15 mg/Day (Week 12)|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458065|NCT00630539|O5|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458066|NCT00630539|O4|Outcome|Subjects on Ospemifene 5 mg/Day (Week 12)|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458067|NCT00630539|O3|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458068|NCT00630539|O2|Outcome|Subjects on Placebo (Week 12)|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458069|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458070|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458071|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458072|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458073|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458074|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458075|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458076|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458077|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458078|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458079|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458080|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458081|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458082|NCT00630539|E4|Reported Event|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
458083|NCT00630539|E3|Reported Event|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
458084|NCT00630539|E2|Reported Event|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
458085|NCT00630539|E1|Reported Event|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
458086|NCT00630734|B4|Baseline|Total|Total of all reporting groups
458087|NCT00630734|B3|Baseline|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458174|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458088|NCT00630734|B2|Baseline|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458089|NCT00630734|B1|Baseline|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458090|NCT00630734|P3|Participant Flow|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458091|NCT00630734|P2|Participant Flow|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
458092|NCT00630734|P1|Participant Flow|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458093|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458094|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
458095|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458096|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458097|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
458098|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458099|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458100|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
458101|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458102|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458103|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
458104|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458105|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458422|NCT00631189|E4|Reported Event|Rosuvastatin|Rosuvastatin 5 mg
458106|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458107|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458108|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458109|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458110|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458111|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458112|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458113|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
459626|NCT00633256|O2|Outcome|Placebo|Matched placebo
458114|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458115|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458116|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458117|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458118|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458119|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458120|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458121|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458122|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1*1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
458123|NCT00630734|E3|Reported Event|Pravastatin + Darunavir/Ritonavir|Darunavir/ritonavir 600/100 mg by mouth twice daily and pravastatin 40 mg by mouth once daily on days 15-18. Includes 28 participants who received at least one dose of darunavir/ritonavir and pravastatin during days 15-18.
458124|NCT00630734|E2|Reported Event|Darunavir/Ritonavir Alone|Darunavir/Ritonavir 600/100 mg by mouth twice daily on days 12-14; Includes 31 participants who received at least one dose of darunavir/ritonavir during days 12-14.
458125|NCT00630734|E1|Reported Event|Pravastatin Alone|Pravastatin 40 mg by mouth daily on days 1-4; Includes 32 participants who received at least one dose of pravastatin 40 mg during days 1-4.
458126|NCT00630747|B1|Baseline|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
458127|NCT00630747|P1|Participant Flow|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 milligram per kilogram (mg/kg) administered by intravenous (IV) infusion once-weekly.
458128|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
458129|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
458130|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
458131|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
458132|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
458133|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
458134|NCT00630747|E1|Reported Event|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
458135|NCT00630786|B4|Baseline|Total|Total of all reporting groups
458136|NCT00630786|B3|Baseline|Unknown KRAS|Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458294|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
458137|NCT00630786|B2|Baseline|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458138|NCT00630786|B1|Baseline|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458139|NCT00630786|P3|Participant Flow|Unknown KRAS|Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458140|NCT00630786|P2|Participant Flow|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458141|NCT00630786|P1|Participant Flow|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458142|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458143|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458144|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458145|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458146|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458147|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458148|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458149|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458150|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458151|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458152|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458153|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458154|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458155|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458156|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458157|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
458158|NCT00630786|E1|Reported Event|Panitumumab + AMG 655|
458159|NCT00630825|B5|Baseline|Total|Total of all reporting groups
458160|NCT00630825|B4|Baseline|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458161|NCT00630825|B3|Baseline|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458162|NCT00630825|B2|Baseline|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458295|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
458163|NCT00630825|B1|Baseline|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458164|NCT00630825|P4|Participant Flow|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458165|NCT00630825|P3|Participant Flow|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458166|NCT00630825|P2|Participant Flow|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458167|NCT00630825|P1|Participant Flow|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458168|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458169|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458170|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458171|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458172|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458173|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458175|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
467401|NCT00654498|O2|Outcome|Placebo|
458176|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458177|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458178|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458179|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458180|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458181|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458182|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458183|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458184|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458185|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458186|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458187|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458188|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458189|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458190|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458191|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458192|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458193|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458194|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458195|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458196|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458197|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458198|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458199|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458200|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458201|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458202|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458203|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458418|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
458204|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458205|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458206|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458207|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458208|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458209|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458210|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458211|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458212|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458213|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458214|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458215|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458216|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
467402|NCT00654498|O1|Outcome|Pramipexole|
458217|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458218|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458219|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458220|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458221|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458222|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458223|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458224|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458225|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458226|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458227|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458228|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458229|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458230|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458231|NCT00630825|E4|Reported Event|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
458232|NCT00630825|E3|Reported Event|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
458233|NCT00630825|E2|Reported Event|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
458234|NCT00630825|E1|Reported Event|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
458235|NCT00630838|B3|Baseline|Total|Total of all reporting groups
458236|NCT00630838|B2|Baseline|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months
Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
458237|NCT00630838|B1|Baseline|VSL#3 Probiotic|"VSL#3 probiotic
VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.
E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
458251|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458419|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
458238|NCT00630838|P2|Participant Flow|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months
Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
458239|NCT00630838|P1|Participant Flow|VSL#3 Probiotic|"VSL#3 probiotic
VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.
E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
458240|NCT00630838|O2|Outcome|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months
Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
458307|NCT00630916|P1|Participant Flow|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
458557|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
458241|NCT00630838|O1|Outcome|VSL#3 Probiotic|"VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.
E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
458242|NCT00630838|O2|Outcome|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months
Placebo: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
458243|NCT00630838|O1|Outcome|VSL#3 Probiotic|"VSL#3: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.
E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
458244|NCT00630838|E2|Reported Event|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months
Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
458245|NCT00630838|E1|Reported Event|VSL#3 Probiotic|"VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.
E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
458246|NCT00630864|B1|Baseline|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458247|NCT00630864|P1|Participant Flow|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458248|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458249|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458250|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458292|NCT00630877|O2|Outcome|Nonresponders|Subjects whose flushing symptoms did not change or worsened from study start to Day 43.
458293|NCT00630877|O1|Outcome|Responders|Subjects whose flushing symptoms improved from study start to Day 43.
458252|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458253|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458254|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458255|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458308|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
467403|NCT00654498|O2|Outcome|Placebo|
458256|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458257|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458258|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458259|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458260|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458261|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458262|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458263|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458264|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458265|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458266|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458267|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458268|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
534428|NCT00815347|O1|Outcome|Placebo|
458269|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458270|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458271|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458272|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458273|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458274|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458275|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458276|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458277|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458278|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458279|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458280|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458281|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458282|NCT00630864|E1|Reported Event|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
458283|NCT00630877|B4|Baseline|Total|Total of all reporting groups
458284|NCT00630877|B3|Baseline|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
458285|NCT00630877|B2|Baseline|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
458286|NCT00630877|B1|Baseline|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
458287|NCT00630877|P3|Participant Flow|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
458288|NCT00630877|P2|Participant Flow|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
458289|NCT00630877|P1|Participant Flow|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
458290|NCT00630877|O2|Outcome|Nonresponders|Subjects whose flushing symptoms did not change or worsened from study start to Day 43.
458291|NCT00630877|O1|Outcome|Responders|Subjects whose flushing symptoms improved from study start to Day 43.
458420|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
458296|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
458297|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
458298|NCT00630877|O1|Outcome|Subjects With Stable Flushing Symptoms|Subjects whose flushing symptoms remained stable from Week 1 to Week 2
458299|NCT00630877|O3|Outcome|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
458300|NCT00630877|O2|Outcome|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
458301|NCT00630877|O1|Outcome|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
458302|NCT00630877|O1|Outcome|Subjects With Stable Flushing Symptoms|Subjects whose flushing symptoms remained stable from Week 1 to Week 2
458303|NCT00630877|E3|Reported Event|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
458304|NCT00630877|E2|Reported Event|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
458305|NCT00630877|E1|Reported Event|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
458306|NCT00630916|B1|Baseline|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
458309|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
458310|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
458311|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
458312|NCT00630916|E1|Reported Event|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
458313|NCT00630955|B4|Baseline|Total|Total of all reporting groups
458314|NCT00630955|B3|Baseline|40 mg Memantine|
458315|NCT00630955|B2|Baseline|20 mg Memantine|
458316|NCT00630955|B1|Baseline|0 mg Memantine|
458317|NCT00630955|P3|Participant Flow|40 mg Memantine|Participants randomized to 40mg memantine PO qd
458318|NCT00630955|P2|Participant Flow|20 mg Memantine|Participants randomized to 20 mg memantine PO qd
458319|NCT00630955|P1|Participant Flow|0 mg Memantine|Participants who received placebo PO qd
458320|NCT00630955|O3|Outcome|40 mg Memantine|Participants randomized to 40mg memantine
458321|NCT00630955|O2|Outcome|20 mg Memantine|Participants randomized to 20 mg memantine
458322|NCT00630955|O1|Outcome|0 mg Memantine|Participants who received placebo
458323|NCT00630955|O3|Outcome|40 mg Memantine|Participants randomized to 40mg memantine
458324|NCT00630955|O2|Outcome|20 mg Memantine|Participants randomized to 20 mg memantine
458325|NCT00630955|O1|Outcome|0 mg Memantine|Participants who received placebo
458326|NCT00630955|E3|Reported Event|40 mg|Participants randomized to 40mg memantine
458327|NCT00630955|E2|Reported Event|20 mg|Participants randomized to 20 mg memantine
458328|NCT00630955|E1|Reported Event|0 mg|Participants who received placebo
458329|NCT00630994|B1|Baseline|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
458330|NCT00630994|P1|Participant Flow|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
458331|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
458332|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
458333|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
458334|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
458335|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
458336|NCT00630994|E1|Reported Event|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
458337|NCT00631007|B7|Baseline|Total|Total of all reporting groups
458338|NCT00631007|B6|Baseline|Placebo|placebo administered once-daily
458339|NCT00631007|B5|Baseline|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
458340|NCT00631007|B4|Baseline|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
458341|NCT00631007|B3|Baseline|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
458342|NCT00631007|B2|Baseline|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
458343|NCT00631007|B1|Baseline|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
458344|NCT00631007|P6|Participant Flow|Placebo|placebo administered once-daily
458345|NCT00631007|P5|Participant Flow|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
458346|NCT00631007|P4|Participant Flow|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
458347|NCT00631007|P3|Participant Flow|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
458423|NCT00631189|E3|Reported Event|Pravastatin|Pravastatin 40 mg
458348|NCT00631007|P2|Participant Flow|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
458349|NCT00631007|P1|Participant Flow|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
458350|NCT00631007|O6|Outcome|Placebo|placebo administered once-daily
458351|NCT00631007|O5|Outcome|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
458352|NCT00631007|O4|Outcome|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
458353|NCT00631007|O3|Outcome|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
458354|NCT00631007|O2|Outcome|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
458355|NCT00631007|O1|Outcome|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
458356|NCT00631007|O6|Outcome|Placebo|placebo administered once-daily
458357|NCT00631007|O5|Outcome|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
458358|NCT00631007|O4|Outcome|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
458359|NCT00631007|O3|Outcome|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
458360|NCT00631007|O2|Outcome|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
458361|NCT00631007|O1|Outcome|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
458362|NCT00631007|E6|Reported Event|Placebo|placebo administered once-daily
459627|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
458363|NCT00631007|E5|Reported Event|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
458364|NCT00631007|E4|Reported Event|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
458365|NCT00631007|E3|Reported Event|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
458366|NCT00631007|E2|Reported Event|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
458367|NCT00631007|E1|Reported Event|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
458368|NCT00631020|B1|Baseline|CBME +/- NRT|6 weeks of once a week CBME with optional 4 weeks NRT
458369|NCT00631020|P1|Participant Flow|CBME +/- NRT|6 weeks CBME with optional NRT for 4 weeks
458370|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
458371|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
458372|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
458373|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
458374|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
458375|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
458376|NCT00631020|E1|Reported Event|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
458377|NCT00631189|B5|Baseline|Total|Total of all reporting groups
458378|NCT00631189|B4|Baseline|Rosuvastatin|Rosuvastatin 5 mg
458379|NCT00631189|B3|Baseline|Pravastatin|Pravastatin 40 mg
458380|NCT00631189|B2|Baseline|Atorvastatin|Atorvastatin 10 mg
458381|NCT00631189|B1|Baseline|Initial Phase|Initial phase (between V1 and V2)
458382|NCT00631189|P4|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg
458383|NCT00631189|P3|Participant Flow|Pravastatin|Pravastatin 40 mg
458384|NCT00631189|P2|Participant Flow|Atorvastatin|Atorvastatin 10 mg
458385|NCT00631189|P1|Participant Flow|Initial Phase|Initial phase (between V1 and V2)
458386|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
458387|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
458388|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
458389|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
458390|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
458391|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
458392|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
458393|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
458394|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
458395|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
458396|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
458397|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
458398|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
458399|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
458400|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
458401|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
458402|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
458403|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
458404|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
458405|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
458406|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
458407|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
458408|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
458409|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
458410|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
458411|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
458412|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
458413|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
458414|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
458415|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
458416|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
458417|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
458425|NCT00631189|E1|Reported Event|Initial Phase|Initial phase (between V1 and V2)
458426|NCT00631358|B3|Baseline|Total|Total of all reporting groups
458427|NCT00631358|B2|Baseline|No Treatment|Healthy normal control group receiving no treatment
458428|NCT00631358|B1|Baseline|Maxidex|Maxidex 1 drop in each eye 2 times daily
458429|NCT00631358|P2|Participant Flow|No Treatment|Healthy normal control group receiving no treatment
458430|NCT00631358|P1|Participant Flow|Maxidex|Maxidex 1 drop in each eye 2 times daily
458431|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
458432|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
458433|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
458434|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
458435|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
458436|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
458437|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
458438|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
458439|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
458440|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
458441|NCT00631358|E2|Reported Event|No Treatment|Healthy normal control group receiving no treatment
458442|NCT00631358|E1|Reported Event|Maxidex|Maxidex 1 drop in each eye 2 times daily
458443|NCT00631371|B3|Baseline|Total|Total of all reporting groups
458558|NCT00631657|E2|Reported Event|Placebo|Participants receive placebo tablets, administered QD
458444|NCT00631371|B2|Baseline|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458445|NCT00631371|B1|Baseline|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458446|NCT00631371|P2|Participant Flow|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458447|NCT00631371|P1|Participant Flow|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458448|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458449|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458450|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458451|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458452|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458453|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458454|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458455|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458456|NCT00631371|E2|Reported Event|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
552226|NCT00852917|O4|Outcome|4: Placebo|
458457|NCT00631371|E1|Reported Event|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
458458|NCT00631410|B3|Baseline|Total|Total of all reporting groups
458459|NCT00631410|B2|Baseline|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).
FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
458460|NCT00631410|B1|Baseline|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458498|NCT00631488|B1|Baseline|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
458461|NCT00631410|P2|Participant Flow|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458462|NCT00631410|P1|Participant Flow|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458463|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458464|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and ℓ-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458465|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458466|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458467|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458468|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458469|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458470|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458494|NCT00631475|E1|Reported Event|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
458495|NCT00631488|B4|Baseline|Total|Total of all reporting groups
458471|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).
FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
458472|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).
FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
458499|NCT00631488|P3|Participant Flow|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458473|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).
FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
458474|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458475|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and ℓ-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458476|NCT00631410|E2|Reported Event|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).
FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
458477|NCT00631410|E1|Reported Event|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
458478|NCT00631449|B3|Baseline|Total|Total of all reporting groups
458479|NCT00631449|B2|Baseline|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
458480|NCT00631449|B1|Baseline|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
458481|NCT00631449|P2|Participant Flow|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
458482|NCT00631449|P1|Participant Flow|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
458483|NCT00631449|O2|Outcome|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
458484|NCT00631449|O1|Outcome|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
458485|NCT00631449|E2|Reported Event|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
458486|NCT00631449|E1|Reported Event|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
458487|NCT00631475|B1|Baseline|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
458488|NCT00631475|P1|Participant Flow|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
458489|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
458490|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
458491|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
458492|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
458493|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
466069|NCT00650858|B2|Baseline|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
458496|NCT00631488|B3|Baseline|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458497|NCT00631488|B2|Baseline|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458500|NCT00631488|P2|Participant Flow|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458501|NCT00631488|P1|Participant Flow|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
458502|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458503|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458504|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
458505|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458506|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458507|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
458508|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458509|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458510|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
458540|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
458541|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
458542|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
458511|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458512|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458513|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
458514|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458515|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458516|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
458517|NCT00631488|E3|Reported Event|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458518|NCT00631488|E2|Reported Event|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
458519|NCT00631488|E1|Reported Event|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
458520|NCT00631540|B1|Baseline|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
458521|NCT00631540|P1|Participant Flow|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
458522|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
458523|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
458524|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
458525|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
458526|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
458527|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
458528|NCT00631540|E1|Reported Event|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
458529|NCT00631657|B3|Baseline|Total|Total of all reporting groups
458530|NCT00631657|B2|Baseline|Placebo|Participants receive placebo tablets, administered QD for 6 months
458531|NCT00631657|B1|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
458532|NCT00631657|P3|Participant Flow|Placebo/Placebo|Participants receive placebo tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days
458533|NCT00631657|P2|Participant Flow|Esmirtazapine 4.5 mg/Placebo|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days
458534|NCT00631657|P1|Participant Flow|Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered once a day (QD) for 6 months, then participants receive esmirtazapine 4.5 mg tablets, administered QD for 7 days
458535|NCT00631657|O3|Outcome|Placebo/Placebo|Participants receive placebo tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period
458536|NCT00631657|O2|Outcome|Esmirtazapine 4.5 mg/Placebo|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period
458537|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by esmirtazapine 4.5 mg tablets, administered QD for 7 days during the Discontinuation Period
458538|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months.
458539|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
566583|NCT00903630|B3|Baseline|Phase 2|
458543|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
458544|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
458545|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
458546|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
458547|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
458548|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
458549|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
458550|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
458551|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
458552|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD
458553|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
458554|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD
458555|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
458556|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
467404|NCT00654498|O1|Outcome|Pramipexole|
458559|NCT00631657|E1|Reported Event|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD
458560|NCT00631670|B3|Baseline|Total|Total of all reporting groups
458561|NCT00631670|B2|Baseline|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
458562|NCT00631670|B1|Baseline|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
458563|NCT00631670|P2|Participant Flow|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
458564|NCT00631670|P1|Participant Flow|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
458565|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
458566|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
458567|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
458568|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
458569|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
458570|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
458571|NCT00631670|O2|Outcome|25 Treatments Grouop|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
458572|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one treatment
458573|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
458574|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
458575|NCT00631670|E2|Reported Event|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
458576|NCT00631670|E1|Reported Event|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
458577|NCT00631696|B3|Baseline|Total|Total of all reporting groups
458578|NCT00631696|B2|Baseline|Placebo|Placebo matching pregabalin treatment.
458579|NCT00631696|B1|Baseline|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458580|NCT00631696|P2|Participant Flow|Placebo|Placebo matching pregabalin treatment.
458581|NCT00631696|P1|Participant Flow|Pregabalin|Pregabalin 50 milligrams (mg) by mouth (PO) twice a day (BID) starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458582|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
458583|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458584|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
458585|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458586|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
458587|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458588|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
458589|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458590|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
458591|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458592|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
458593|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458594|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
458595|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458596|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
458597|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458598|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
458599|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458600|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
458601|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458602|NCT00631696|E2|Reported Event|Placebo|Placebo matching pregabalin treatment.
459628|NCT00633256|E2|Reported Event|Placebo|Matched placebo
458603|NCT00631696|E1|Reported Event|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
458604|NCT00631748|B3|Baseline|Total|Total of all reporting groups
458605|NCT00631748|B2|Baseline|Placebo|Placebo (sugar pill)
458606|NCT00631748|B1|Baseline|Study Drug|Oral quetiapine
458607|NCT00631748|P2|Participant Flow|Placebo|Placebo (sugar pill)
458608|NCT00631748|P1|Participant Flow|Study Drug|Oral quetiapine
458609|NCT00631748|O2|Outcome|Placebo|match placebo (sugar pill)
458610|NCT00631748|O1|Outcome|Study Drug|Quetiapine (Seroquel XR)
458611|NCT00631748|O2|Outcome|Placebo|matched placebo (sugar pill)
458612|NCT00631748|O1|Outcome|Study Drug|Quetiapine (Seroquel XR)
458613|NCT00631748|E2|Reported Event|Placebo|Placebo (sugar pill)
458614|NCT00631748|E1|Reported Event|Study Drug|Oral quetiapine
458615|NCT00631917|B3|Baseline|Total|Total of all reporting groups
458616|NCT00631917|B2|Baseline|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
458617|NCT00631917|B1|Baseline|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
458618|NCT00631917|P2|Participant Flow|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
458619|NCT00631917|P1|Participant Flow|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
458620|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
458621|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
458622|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
458623|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
458624|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
458625|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
458626|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
458627|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
458628|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
458629|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
458630|NCT00631917|E2|Reported Event|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
458631|NCT00631917|E1|Reported Event|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
458632|NCT00631969|B3|Baseline|Total|Total of all reporting groups
458633|NCT00631969|B2|Baseline|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458634|NCT00631969|B1|Baseline|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458635|NCT00631969|P2|Participant Flow|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458636|NCT00631969|P1|Participant Flow|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458637|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
458638|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
458800|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458639|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
458640|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
458641|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
458642|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
458643|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
458644|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
458645|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458646|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458647|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458648|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458649|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458650|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458651|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458652|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458653|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458654|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458655|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458656|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458657|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458658|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458659|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458660|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458661|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458662|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458663|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458664|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458788|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458665|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458666|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458667|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458668|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458669|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458670|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458671|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458672|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458673|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
459629|NCT00633256|E1|Reported Event|Cycloserine|50 mg cycloserine
458674|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458675|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458676|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458677|NCT00631969|E2|Reported Event|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458678|NCT00631969|E1|Reported Event|Vardenafil ODT (STAXYN, BAY 38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
458679|NCT00622635|B1|Baseline|Entire Study Population|The entire study population included all 6 treatment groups who received indacaterol 300 µg once daily, placebo to indacaterol once daily, and salmeterol 50 µg twice daily via a single-dose (indacaterol and placebo to indacaterol) or multi-dose (salmeterol) dry-powder inhaler in 6 different sequences. Patients received each treatment for 14 days with a 14 day washout between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458680|NCT00622635|P6|Participant Flow|Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg|In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458681|NCT00622635|P5|Participant Flow|Indacaterol 300 μg - Salmeterol 50 μg - Placebo to Indacaterol|In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458682|NCT00622635|P4|Participant Flow|Placebo to Indacaterol - Indacaterol 300 μg - Salmeterol 50 μg|In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458683|NCT00622635|P3|Participant Flow|Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol|In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458702|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458789|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458790|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458684|NCT00622635|P2|Participant Flow|Placebo to Indacaterol - Salmeterol 50 μg - Indacaterol 300 μg|In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458685|NCT00622635|P1|Participant Flow|Indacaterol 300 μg - Placebo to Indacaterol - Salmeterol 50 μg|In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458801|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458802|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458686|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458687|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458688|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458689|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458690|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458691|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458692|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458693|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458694|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458695|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458696|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458697|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458698|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458699|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458700|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458701|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458783|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458703|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458704|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458705|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458706|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458803|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
459630|NCT00633360|B3|Baseline|Total|Total of all reporting groups
458707|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458708|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458709|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458710|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458711|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458712|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458713|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458714|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458715|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458716|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458717|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458718|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458719|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458720|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458721|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458722|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458784|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458785|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
466070|NCT00650858|B1|Baseline|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
458723|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458724|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458725|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458726|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458727|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458728|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458729|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458730|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458731|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458732|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458733|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458734|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458735|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458736|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458737|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458738|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458739|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458740|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458741|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458742|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458786|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458787|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
466079|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
458743|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458744|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458745|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458804|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458805|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458806|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458746|NCT00622635|E3|Reported Event|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458747|NCT00622635|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458748|NCT00622635|E1|Reported Event|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
458749|NCT00622700|B4|Baseline|Total|Total of all reporting groups
458750|NCT00622700|B3|Baseline|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458751|NCT00622700|B2|Baseline|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458752|NCT00622700|B1|Baseline|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458753|NCT00622700|P7|Participant Flow|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.
Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
458754|NCT00622700|P6|Participant Flow|Placebo/Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
458755|NCT00622700|P5|Participant Flow|Teriflunomide 7 mg/7 mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.
Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
458756|NCT00622700|P4|Participant Flow|Placebo/ Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
458757|NCT00622700|P3|Participant Flow|Teriflunomide 14 mg|Core treatment period: Teriflunomide 14 mg tablet once daily orally.
458758|NCT00622700|P2|Participant Flow|Teriflunomide 7 mg|Core treatment period: Teriflunomide 7 mg tablet once daily orally.
458759|NCT00622700|P1|Participant Flow|Placebo|Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
458760|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458761|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458762|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458763|NCT00622700|O4|Outcome|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.
Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
458764|NCT00622700|O3|Outcome|Placebo/ Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
458765|NCT00622700|O2|Outcome|Teriflunomide 7 mg/ 7mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.
Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
458766|NCT00622700|O1|Outcome|Placebo/Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
458767|NCT00622700|O4|Outcome|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.
Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
458768|NCT00622700|O3|Outcome|Placebo/ Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
458769|NCT00622700|O2|Outcome|Teriflunomide 7 mg/ 7mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
458770|NCT00622700|O1|Outcome|Placebo/Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
458771|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458772|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458773|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458774|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458775|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458776|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458777|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458778|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458779|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458780|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458781|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458782|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
466080|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
458791|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458792|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458793|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458794|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458795|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458796|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458797|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458798|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458799|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458807|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
458808|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
458809|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
458810|NCT00622700|E7|Reported Event|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.
Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
458811|NCT00622700|E6|Reported Event|Placebo/Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
458812|NCT00622700|E5|Reported Event|Teriflunomide 7 mg/7 mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.
Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
458813|NCT00622700|E4|Reported Event|Placebo/Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
458814|NCT00622700|E3|Reported Event|Teriflunomide 14 mg|Core treatment period: Teriflunomide 14 mg tablet once daily orally.
458815|NCT00622700|E2|Reported Event|Teriflunomide 7 mg|Core treatment period: Teriflunomide 7 mg tablet once daily orally.
458816|NCT00622700|E1|Reported Event|Placebo|Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
458817|NCT00622713|B1|Baseline|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
458818|NCT00622713|P1|Participant Flow|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
458819|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
458820|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
458821|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
458822|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
458823|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
458824|NCT00622713|E1|Reported Event|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
458825|NCT00622726|B3|Baseline|Total|Total of all reporting groups
458826|NCT00622726|B2|Baseline|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
459505|NCT00632970|E1|Reported Event|Raltegravir|Raltegravir: 1 400mg tablet twice a day
458827|NCT00622726|B1|Baseline|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
458828|NCT00622726|P2|Participant Flow|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
458829|NCT00622726|P1|Participant Flow|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
458830|NCT00622726|O4|Outcome|Conventional Laser-Control Group: Posterior Zone II|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Posterior Zone II.
458831|NCT00622726|O3|Outcome|Bevacizumab Experimental Group: Posterior Zone II|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Posterior Zone II.
458832|NCT00622726|O2|Outcome|Conventional Laser-Control Group: Zone I|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Zone I.
458833|NCT00622726|O1|Outcome|Bevacizumab-Experimental Group: Zone I|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Zone I.
459631|NCT00633360|B2|Baseline|Placebo|"Placebo
Placebo: Once daily by mouth"
467405|NCT00654498|O2|Outcome|Placebo|
458834|NCT00622726|O2|Outcome|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients/66 eyes had zone I ROP; 40 patients/80 eyes had posterior zone II ROP.
458835|NCT00622726|O1|Outcome|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients/62 eyes had zone I ROP; 39 patients/78 eyes had zone II posterior ROP.
458836|NCT00622726|E2|Reported Event|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
458837|NCT00622726|E1|Reported Event|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
458838|NCT00622739|B3|Baseline|Total|Total of all reporting groups
458839|NCT00622739|B2|Baseline|Ziprasidone Slow Dose Group|"Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
458840|NCT00622739|B1|Baseline|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
458841|NCT00622739|P2|Participant Flow|Ziprasidone Slow Dose Group|"Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
458842|NCT00622739|P1|Participant Flow|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
458843|NCT00622739|O2|Outcome|Ziprasidone Slow Dose Group|"Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
458844|NCT00622739|O1|Outcome|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
458845|NCT00622739|E2|Reported Event|Ziprasidone Slow Dose Group|"Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
458846|NCT00622739|E1|Reported Event|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
458847|NCT00622869|B4|Baseline|Total|Total of all reporting groups
458848|NCT00622869|B3|Baseline|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
458849|NCT00622869|B2|Baseline|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
458850|NCT00622869|B1|Baseline|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
458851|NCT00622869|P3|Participant Flow|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
458852|NCT00622869|P2|Participant Flow|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
458853|NCT00622869|P1|Participant Flow|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
458854|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
458855|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
458856|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
458857|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
458858|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
458859|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
458860|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
458861|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
458862|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
458863|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
458864|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
458865|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
458866|NCT00622869|E3|Reported Event|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids
459790|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
458867|NCT00622869|E2|Reported Event|Tacrolimus Elimination|Low dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids
458868|NCT00622869|E1|Reported Event|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids
458869|NCT00622908|B3|Baseline|Total|Total of all reporting groups
458870|NCT00622908|B2|Baseline|Vehicle|Vehicle of ISV-403
458871|NCT00622908|B1|Baseline|ISV-403|0.6% ISV-403
458872|NCT00622908|P2|Participant Flow|Vehicle|Vehicle of ISV-403
458873|NCT00622908|P1|Participant Flow|ISV-403|0.6% ISV-403
458874|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
458875|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
458876|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
458877|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
458878|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
458879|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
458880|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
458881|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
458882|NCT00622908|E2|Reported Event|Vehicle|Vehicle of ISV-403
458883|NCT00622908|E1|Reported Event|ISV-403|0.6% ISV-403
458884|NCT00623012|B1|Baseline|Rapamycin Study Arm|"Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.
Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
458885|NCT00623012|P1|Participant Flow|Study Population|"This is a single arm study:
Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.
Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
458886|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:
Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.
Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
458887|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:
Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.
Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
458906|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
458907|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
458888|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:
Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.
Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
458910|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
458911|NCT00623103|E2|Reported Event|Exelon Patch|Exelon Patch
458912|NCT00623103|E1|Reported Event|Exelon Capsule|Exelon Capsule
458913|NCT00623181|B3|Baseline|Total|Total of all reporting groups
459791|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
458889|NCT00623012|E1|Reported Event|Study Arm|"Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.
Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
458890|NCT00623103|B3|Baseline|Total|Total of all reporting groups
458891|NCT00623103|B2|Baseline|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
458892|NCT00623103|B1|Baseline|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
458893|NCT00623103|P2|Participant Flow|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
458894|NCT00623103|P1|Participant Flow|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
458895|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
458896|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
458897|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
458898|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
458899|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
458900|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
458901|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
458902|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
458903|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
458904|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
458905|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
458942|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
459506|NCT00633009|B4|Baseline|Total|Total of all reporting groups
458908|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
458909|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
458914|NCT00623181|B2|Baseline|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
458915|NCT00623181|B1|Baseline|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
458916|NCT00623181|P2|Participant Flow|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
458917|NCT00623181|P1|Participant Flow|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
458918|NCT00623181|O2|Outcome|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
458919|NCT00623181|O1|Outcome|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
458920|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0.
458921|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
458922|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
458923|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0.
458924|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
458925|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
458926|NCT00623181|E2|Reported Event|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
458927|NCT00623181|E1|Reported Event|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
458928|NCT00623194|B1|Baseline|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458929|NCT00623194|P1|Participant Flow|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458930|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458931|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458932|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458933|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458934|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458935|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458936|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458937|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458938|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458939|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458940|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458941|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458943|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458944|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458945|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458946|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458947|NCT00623194|E1|Reported Event|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
458948|NCT00623233|B1|Baseline|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
458990|NCT00632203|O2|Outcome|Observation|Observation
459792|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
458949|NCT00623233|P1|Participant Flow|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
458950|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
458951|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
458952|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
458953|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
458954|NCT00623233|E1|Reported Event|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
458955|NCT00632021|B3|Baseline|Total|Total of all reporting groups
458956|NCT00632021|B2|Baseline|Intervention|Intervention arm
458957|NCT00632021|B1|Baseline|Control (Usual Care)|Control (usual care) arm
458958|NCT00632021|P2|Participant Flow|Intervention|Intervention arm
458959|NCT00632021|P1|Participant Flow|Control (Usual Care)|Control (usual care) arm
458960|NCT00632021|O2|Outcome|Intervention|Intervention arm
458961|NCT00632021|O1|Outcome|Control (Usual Care)|Control (usual care) arm
458962|NCT00632021|O2|Outcome|Intervention|Intervention arm
458963|NCT00632021|O1|Outcome|Control|Control (usual care) arm
458964|NCT00632021|E2|Reported Event|Intervention|Intervention arm
458965|NCT00632021|E1|Reported Event|Control (Usual Care)|Control (usual care) arm
458966|NCT00632099|B3|Baseline|Total|Total of all reporting groups
458967|NCT00632099|B2|Baseline|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)
Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
458968|NCT00632099|B1|Baseline|Matched Placebo|"matched placebo
Placebo: matched placebo"
458969|NCT00632099|P2|Participant Flow|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)
Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
458970|NCT00632099|P1|Participant Flow|Matched Placebo|"matched placebo
Placebo: matched placebo"
458971|NCT00632099|O2|Outcome|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)
Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
458972|NCT00632099|O1|Outcome|Matched Placebo|"matched placebo
Placebo: matched placebo"
458973|NCT00632099|E2|Reported Event|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)
Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
458974|NCT00632099|E1|Reported Event|Matched Placebo|"matched placebo
Placebo: matched placebo"
458975|NCT00632125|B1|Baseline|HX575|HX575 recombinant human erythropoietin alfa: HX575 epoetin alfa i.v. will be administered according to the SmPC
458976|NCT00632125|P1|Participant Flow|HX575|HX575 recombinant human erythropoietin alfa: HX575 epoetin alfa i.v. will be administered according to the summary of product characteristics (SmPC)
458977|NCT00632125|O1|Outcome|HX575|HX575 administered i.v. according to the SmPC
458978|NCT00632125|E1|Reported Event|HX575|HX575 administered i.v. according to the SmPC
458979|NCT00632203|B3|Baseline|Total|Total of all reporting groups
458980|NCT00632203|B2|Baseline|Observation|Observation
458981|NCT00632203|B1|Baseline|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
458982|NCT00632203|P2|Participant Flow|Observation|Observation
459025|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
458983|NCT00632203|P1|Participant Flow|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
458984|NCT00632203|O2|Outcome|Observation|Observation
458985|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
458986|NCT00632203|O2|Outcome|Observation|Observation
458987|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
458988|NCT00632203|O2|Outcome|Observation|Observation
458989|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
458991|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
458992|NCT00632203|O2|Outcome|Observation|Observation
458993|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
458994|NCT00632203|O2|Outcome|Observation|Observation
458995|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
458996|NCT00632203|O2|Outcome|Observation|Observation
458997|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
458998|NCT00632203|E2|Reported Event|Observation|Observation
458999|NCT00632203|E1|Reported Event|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
459000|NCT00632229|B3|Baseline|Total|Total of all reporting groups
459001|NCT00632229|B2|Baseline|Placebo|"Placebo comparator
Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
459002|NCT00632229|B1|Baseline|Paliperidone|"Recieves study medication
Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
459003|NCT00632229|P2|Participant Flow|Placebo|"Placebo comparator
Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
459004|NCT00632229|P1|Participant Flow|Paliperidone|"Recieves study medication
Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
459005|NCT00632229|O2|Outcome|Placebo|"Placebo comparator
Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
459006|NCT00632229|O1|Outcome|Paliperidone|"Recieves study medication
Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
459007|NCT00632229|O2|Outcome|Placebo|"Placebo comparator
Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
459008|NCT00632229|O1|Outcome|Paliperidone|"Recieves study medication
Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
459009|NCT00632229|E2|Reported Event|Placebo|"Placebo comparator
Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
459010|NCT00632229|E1|Reported Event|Paliperidone|"Recieves study medication
Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
459011|NCT00632281|B1|Baseline|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
459012|NCT00632281|P1|Participant Flow|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
459013|NCT00632281|O1|Outcome|All Patients Receiving SBRT to the Thorax|
459014|NCT00632281|O1|Outcome|All Patients Receiving SBRT to the Thorax|
459015|NCT00632281|E1|Reported Event|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
459016|NCT00632463|B4|Baseline|Total|Total of all reporting groups
459017|NCT00632463|B3|Baseline|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
459018|NCT00632463|B2|Baseline|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
459019|NCT00632463|B1|Baseline|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
459020|NCT00632463|P3|Participant Flow|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
459021|NCT00632463|P2|Participant Flow|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
459022|NCT00632463|P1|Participant Flow|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
459023|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
459024|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
466081|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
459026|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
459027|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
459028|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
459029|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
459030|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
459031|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
459032|NCT00632463|E3|Reported Event|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
459033|NCT00632463|E2|Reported Event|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
459034|NCT00632463|E1|Reported Event|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
459035|NCT00632489|B4|Baseline|Total|Total of all reporting groups
459036|NCT00632489|B3|Baseline|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
459037|NCT00632489|B2|Baseline|LBH589 and Lapatinib|"LBH589 and Lapatinib
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
459038|NCT00632489|B1|Baseline|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
459039|NCT00632489|P3|Participant Flow|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
459040|NCT00632489|P2|Participant Flow|LBH589 and Lapatinib|"LBH589 and Lapatinib
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
459041|NCT00632489|P1|Participant Flow|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
459042|NCT00632489|O3|Outcome|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
459043|NCT00632489|O2|Outcome|LBH589 and Lapatinib|"LBH589 and Lapatinib
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
459044|NCT00632489|O1|Outcome|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
459081|NCT00632541|O1|Outcome|Single Arm A|"Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
Sorafenib: Sorafenib 200mg po daily
Bevacizumab: Bevacizumab 5mg/kg every other week
1 Cycle = 4 weeks
Imaging: Imaging every third cycle"
459082|NCT00632541|E1|Reported Event|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
459083|NCT00632619|B3|Baseline|Total|Total of all reporting groups
459045|NCT00632489|O3|Outcome|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
459046|NCT00632489|O2|Outcome|LBH589 and Lapatinib|"LBH589 and Lapatinib
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
459552|NCT00633074|E1|Reported Event|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
467406|NCT00654498|O1|Outcome|Pramipexole|
459047|NCT00632489|O1|Outcome|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
459048|NCT00632489|E3|Reported Event|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
459049|NCT00632489|E2|Reported Event|LBH589 and Lapatinib|"LBH589 and Lapatinib
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
459050|NCT00632489|E1|Reported Event|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine
LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
459051|NCT00632502|B3|Baseline|Total|Total of all reporting groups
459052|NCT00632502|B2|Baseline|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459053|NCT00632502|B1|Baseline|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459054|NCT00632502|P2|Participant Flow|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459055|NCT00632502|P1|Participant Flow|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459056|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459057|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459058|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459059|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459060|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459061|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459062|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459063|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459064|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459065|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459066|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459067|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459068|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459069|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459070|NCT00632502|O1|Outcome|Navarixin|Navarixin (SCH 537123) 30 mg capsule to be taken by mouth once daily for 4 weeks
459071|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459072|NCT00632502|O1|Outcome|Navarixin|Navarixin (SCH 537123) 30 mg capsule to be taken by mouth once daily for 4 weeks
459073|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459074|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459075|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459076|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459077|NCT00632502|E2|Reported Event|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
459078|NCT00632502|E1|Reported Event|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
459079|NCT00632541|B1|Baseline|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
459080|NCT00632541|P1|Participant Flow|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week. 1 Cycle = 4 weeks. Imaging every third cycle.
459585|NCT00633152|B2|Baseline|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
459084|NCT00632619|B2|Baseline|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
459119|NCT00632749|B14|Baseline|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459085|NCT00632619|B1|Baseline|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
459086|NCT00632619|P2|Participant Flow|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
459087|NCT00632619|P1|Participant Flow|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
459088|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
459089|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
459090|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
459091|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
459092|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
459093|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
459094|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
459544|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459095|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
459443|NCT00632814|P3|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459096|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
459097|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
459098|NCT00632619|E2|Reported Event|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
459099|NCT00632619|E1|Reported Event|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.
Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
459100|NCT00632632|B3|Baseline|Total|Total of all reporting groups
459101|NCT00632632|B2|Baseline|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
459102|NCT00632632|B1|Baseline|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
459103|NCT00632632|P2|Participant Flow|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
459104|NCT00632632|P1|Participant Flow|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
459105|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
459106|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
459107|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
459108|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
459109|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
459110|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
459111|NCT00632632|E2|Reported Event|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
459112|NCT00632632|E1|Reported Event|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
459113|NCT00632736|B1|Baseline|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
459114|NCT00632736|P1|Participant Flow|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
459115|NCT00632736|O1|Outcome|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
459116|NCT00632736|O1|Outcome|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
459545|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459117|NCT00632736|E1|Reported Event|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
459118|NCT00632749|B15|Baseline|Total|Total of all reporting groups
459624|NCT00633256|O2|Outcome|Placebo|Matched placebo
459120|NCT00632749|B13|Baseline|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459121|NCT00632749|B12|Baseline|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459122|NCT00632749|B11|Baseline|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459123|NCT00632749|B10|Baseline|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459124|NCT00632749|B9|Baseline|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459125|NCT00632749|B8|Baseline|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459126|NCT00632749|B7|Baseline|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459127|NCT00632749|B6|Baseline|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459128|NCT00632749|B5|Baseline|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459129|NCT00632749|B4|Baseline|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459130|NCT00632749|B3|Baseline|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459131|NCT00632749|B2|Baseline|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459132|NCT00632749|B1|Baseline|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459133|NCT00632749|P14|Participant Flow|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459134|NCT00632749|P13|Participant Flow|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459135|NCT00632749|P12|Participant Flow|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459136|NCT00632749|P11|Participant Flow|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459137|NCT00632749|P10|Participant Flow|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459138|NCT00632749|P9|Participant Flow|80 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459139|NCT00632749|P8|Participant Flow|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459140|NCT00632749|P7|Participant Flow|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459141|NCT00632749|P6|Participant Flow|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459142|NCT00632749|P5|Participant Flow|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459143|NCT00632749|P4|Participant Flow|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459144|NCT00632749|P3|Participant Flow|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459145|NCT00632749|P2|Participant Flow|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459146|NCT00632749|P1|Participant Flow|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459147|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459148|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459149|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459150|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459151|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459152|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459441|NCT00632814|B2|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
459153|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459154|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459155|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459156|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459157|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459158|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459159|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459160|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459161|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459162|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459163|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459164|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459165|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459166|NCT00632749|O9|Outcome|80 mg BI 811283 +20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459167|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459168|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459169|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459170|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459171|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459172|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459173|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459174|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459175|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459176|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459177|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459178|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459179|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459180|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459181|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459182|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459183|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459184|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459185|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459186|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459187|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459188|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459189|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459190|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459191|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459192|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459193|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459194|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459195|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459196|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459197|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459198|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459199|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459200|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459201|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459202|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459203|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459204|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459205|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459206|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459207|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459208|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459209|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459210|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459211|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459212|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459213|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459214|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459215|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459216|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459217|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459218|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459219|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459220|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459221|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459222|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459223|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459224|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459225|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459226|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459227|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459228|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459229|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459230|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459231|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459232|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459233|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459234|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459235|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459236|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459237|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459238|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459239|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459240|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459241|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459242|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459243|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459244|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459245|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459246|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459247|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459248|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459249|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459250|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459251|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459252|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459253|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459254|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459255|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459256|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459257|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459258|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459259|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459260|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459261|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459262|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459263|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459264|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459265|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459266|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459267|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459268|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459269|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459270|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459271|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459272|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459273|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459274|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459275|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459276|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459277|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459278|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459279|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459280|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459281|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459282|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459283|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459284|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459285|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459286|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459287|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459288|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459289|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459290|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459291|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459292|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459293|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459294|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459295|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459296|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459297|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459298|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459299|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459300|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459301|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459302|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459303|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459304|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459305|NCT00632749|O6|Outcome|120mg (BI 811283+ Cytarabine)- Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459306|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459307|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459308|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine- Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459309|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459310|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459311|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459312|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459313|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459314|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459315|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459316|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459317|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459318|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459319|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459320|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459321|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459322|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459323|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459324|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459325|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459326|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459327|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459328|NCT00632749|O11|Outcome|240 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459329|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459330|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459331|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459332|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459333|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459334|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459335|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459336|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459337|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459338|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459339|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459340|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459341|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459342|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459343|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459344|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459345|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459346|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459347|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459348|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459349|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459350|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459351|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459352|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459353|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459354|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459355|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459356|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459357|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459358|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459359|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459360|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459361|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459362|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459363|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459364|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459365|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459366|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459367|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459368|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459369|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459370|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459371|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459372|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459373|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459374|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459375|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459376|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459377|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459378|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459379|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459380|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459381|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459382|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459383|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459384|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459385|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459386|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459387|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459388|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459389|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459390|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459391|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459392|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459393|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459394|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459395|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459396|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459397|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459398|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459399|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459400|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459401|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459402|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459403|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459404|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459405|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459406|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459407|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459408|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459409|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459410|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459411|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459412|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459413|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459414|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459415|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459416|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459417|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459418|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459419|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459420|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459421|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459422|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459423|NCT00632749|O2|Outcome|Treatment Schedule B|"Subjects received BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle).
BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection).
The starting dose for BI 811283 was 5 mg, with dose levels of 5, 40, 80, 160, 240, 300, 360 and 420 mg being used in Schedule B.
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459444|NCT00632814|P2|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
459424|NCT00632749|O1|Outcome|Treatment Schedule A|"Subjects received BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle).
BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection).
The starting dose for BI 811283 was 5 mg, with dose levels of 5, 15, 30, 60, 100 and 120 mg used in Schedule A.
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459425|NCT00632749|E14|Reported Event|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459426|NCT00632749|E13|Reported Event|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459427|NCT00632749|E12|Reported Event|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459428|NCT00632749|E11|Reported Event|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459429|NCT00632749|E10|Reported Event|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459430|NCT00632749|E9|Reported Event|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459431|NCT00632749|E8|Reported Event|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459432|NCT00632749|E7|Reported Event|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459433|NCT00632749|E6|Reported Event|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459434|NCT00632749|E5|Reported Event|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459435|NCT00632749|E4|Reported Event|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459436|NCT00632749|E3|Reported Event|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459437|NCT00632749|E2|Reported Event|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459438|NCT00632749|E1|Reported Event|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
459439|NCT00632814|B4|Baseline|Total|Total of all reporting groups
459440|NCT00632814|B3|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459503|NCT00632970|O1|Outcome|Raltegravir|Raltegravir: 1 400mg tablet twice a day
459504|NCT00632970|E2|Reported Event|Lopinavir/Ritonavir|Lopinavir/Ritonavir: 2 tablets twice a day
459442|NCT00632814|B1|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459625|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
459445|NCT00632814|P1|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459446|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459447|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
459448|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459449|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459450|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
459451|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459452|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459453|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
459454|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459455|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459456|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
459457|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459458|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459459|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
459460|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459461|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459462|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
459463|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459464|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459465|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
467407|NCT00654498|O2|Outcome|Placebo|
459466|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459467|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459468|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
459469|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459470|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459471|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
459472|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459473|NCT00632814|E3|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
459474|NCT00632814|E2|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
459475|NCT00632814|E1|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
459476|NCT00632931|B1|Baseline|All Participants|All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.
459477|NCT00632931|P3|Participant Flow|All Participants: Part 2|"Vorinostat 400 mg once daily.
Ten participants changed dosage to vorinostat 300 mg daily during Part 2."
459478|NCT00632931|P2|Participant Flow|Placebo Then Vorinostat: Part 1|Single dose matching placebo in Period 1 followed by a three day wash out period, then single dose 800 mg vorinostat in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.
459479|NCT00632931|P1|Participant Flow|Vorinostat Then Placebo: Part 1|Single dose 800 mg vorinostat in Period 1 followed by a three day wash out period, then matching placebo in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.
459480|NCT00632931|O2|Outcome|Placebo|
459481|NCT00632931|O1|Outcome|Vorinostat|
459482|NCT00632931|O2|Outcome|Placebo|
459483|NCT00632931|O1|Outcome|Vorinostat|
459484|NCT00632931|O2|Outcome|Placebo|
459485|NCT00632931|O1|Outcome|Vorinostat|
459486|NCT00632931|O2|Outcome|Placebo|
459487|NCT00632931|O1|Outcome|Vorinostat|
459488|NCT00632931|O2|Outcome|Placebo|
459489|NCT00632931|O1|Outcome|Vorinostat|
459490|NCT00632931|O2|Outcome|Placebo|
459491|NCT00632931|O1|Outcome|Vorinostat|
459492|NCT00632931|O2|Outcome|Placebo|
459493|NCT00632931|O1|Outcome|Vorinostat|
459494|NCT00632931|O2|Outcome|Placebo|
459495|NCT00632931|O1|Outcome|Vorinostat|
459496|NCT00632931|E1|Reported Event|All Participants|All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.
459497|NCT00632970|B3|Baseline|Total|Total of all reporting groups
459498|NCT00632970|B2|Baseline|Lopinavir/Ritonavir|Lopinavir/Ritonavir: 2 tablets twice a day
459499|NCT00632970|B1|Baseline|Raltegravir|Raltegravir: 1 400mg tablet twice a day
459500|NCT00632970|P2|Participant Flow|Lopinavir/Ritonavir|Patients with HIV infection randomized to receive lopinavir/ritonavir with truvada
459501|NCT00632970|P1|Participant Flow|Raltegravir|Patients with HIV infection randomized to receive raltegravir with truvada
459502|NCT00632970|O2|Outcome|Lopinavir/Ritonavir|Lopinavir/Ritonavir: 2 tablets twice a day
459507|NCT00633009|B3|Baseline|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
459508|NCT00633009|B2|Baseline|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
459509|NCT00633009|B1|Baseline|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
459510|NCT00633009|P3|Participant Flow|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
459511|NCT00633009|P2|Participant Flow|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
459512|NCT00633009|P1|Participant Flow|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10. All participants received a placebo skin test concurrently with active drug.
459513|NCT00633009|O3|Outcome|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
459514|NCT00633009|O2|Outcome|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
459515|NCT00633009|O1|Outcome|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
459516|NCT00633009|O3|Outcome|50 ug Study Group|
459517|NCT00633009|O2|Outcome|30 ug Study Group|
459518|NCT00633009|O1|Outcome|15 ug Study Group|
459519|NCT00633009|E3|Reported Event|50 ug Study Group|
459520|NCT00633009|E2|Reported Event|30 ug Study Group|
459521|NCT00633009|E1|Reported Event|15 ug Study Group|
459522|NCT00633074|B3|Baseline|Total|Total of all reporting groups
459523|NCT00633074|B2|Baseline|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459524|NCT00633074|B1|Baseline|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459525|NCT00633074|P2|Participant Flow|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459526|NCT00633074|P1|Participant Flow|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459527|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459528|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459529|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459530|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459531|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459532|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459533|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459534|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459535|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459536|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459537|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459538|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459539|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459540|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459541|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459542|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459543|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459586|NCT00633152|B1|Baseline|Ceftaroline|Intramuscular every 12 hours
459546|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459547|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459548|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459549|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459550|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
459551|NCT00633074|E2|Reported Event|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
459553|NCT00633087|B1|Baseline|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
459554|NCT00633087|P1|Participant Flow|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
459555|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
459556|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
459557|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
459558|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
459559|NCT00633087|E1|Reported Event|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
459560|NCT00633126|B1|Baseline|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
459561|NCT00633126|P1|Participant Flow|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
459562|NCT00633126|O1|Outcome|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
459563|NCT00633126|O1|Outcome|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
459564|NCT00633126|E1|Reported Event|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
459565|NCT00633139|B4|Baseline|Total|Total of all reporting groups
459566|NCT00633139|B3|Baseline|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
459567|NCT00633139|B2|Baseline|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
459568|NCT00633139|B1|Baseline|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
459569|NCT00633139|P3|Participant Flow|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
459570|NCT00633139|P2|Participant Flow|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
459571|NCT00633139|P1|Participant Flow|Cohort 1|Participants received a single dose of rhASA at 25 units per kilogram (U/kg) intravenous (IV) infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
459572|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
459573|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
459574|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
459575|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
459576|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
459577|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
459578|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
459579|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
459580|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
459581|NCT00633139|E3|Reported Event|Cohort 3|Cohort 3: Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
459582|NCT00633139|E2|Reported Event|Cohort 2|Cohort 2: Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
459583|NCT00633139|E1|Reported Event|Cohort 1|Cohort 1: Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
459584|NCT00633152|B3|Baseline|Total|Total of all reporting groups
459587|NCT00633152|P2|Participant Flow|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
459588|NCT00633152|P1|Participant Flow|Ceftaroline|Intramuscular every 12 hours
459589|NCT00633152|O2|Outcome|Linezolid (With or Without Aztreonam)|Linezolid was administered as 600 mg IV infusions over 60 minutes q12h
459590|NCT00633152|O1|Outcome|Ceftaroline|Ceftaroline fosamil was administered 600mg IM every 12 hours
459591|NCT00633152|O2|Outcome|Linezolid (With or Without Aztreonam)|Linezolid was administered as 600 mg Intravenous infusions over 60 minutes every 12 hours
459592|NCT00633152|O1|Outcome|Ceftaroline|Ceftaroline was administered 600 mg as an Intramuscular injection every 12 hours
459593|NCT00633152|E2|Reported Event|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
459594|NCT00633152|E1|Reported Event|Ceftaroline|Intramuscular every 12 hours
459595|NCT00633217|B3|Baseline|Total|Total of all reporting groups
467408|NCT00654498|O1|Outcome|Pramipexole|
459596|NCT00633217|B2|Baseline|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
459597|NCT00633217|B1|Baseline|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
459598|NCT00633217|P2|Participant Flow|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
459599|NCT00633217|P1|Participant Flow|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
459600|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
459601|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
459602|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
459603|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
459604|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
459605|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
459606|NCT00633217|E2|Reported Event|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
459607|NCT00633217|E1|Reported Event|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
459608|NCT00633243|B3|Baseline|Total|Total of all reporting groups
459609|NCT00633243|B2|Baseline|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
459610|NCT00633243|B1|Baseline|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
459611|NCT00633243|P2|Participant Flow|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the pegylated interferon alfa-a (PEG) and weight-based ribavirin (RBV). Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
459612|NCT00633243|P1|Participant Flow|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning weight-based ribavirin (RBV) dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. Pegylated interferon alfa-2a(PEG) was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
459613|NCT00633243|O2|Outcome|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
459614|NCT00633243|O1|Outcome|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
459615|NCT00633243|E2|Reported Event|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
459659|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
459616|NCT00633243|E1|Reported Event|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
459617|NCT00633256|B3|Baseline|Total|Total of all reporting groups
459618|NCT00633256|B2|Baseline|Placebo|Matched placebo
459619|NCT00633256|B1|Baseline|Cycloserine|50 mg cycloserine
459620|NCT00633256|P2|Participant Flow|Placebo|Matched placebo
459621|NCT00633256|P1|Participant Flow|Cycloserine|50 mg cycloserine
459622|NCT00633256|O2|Outcome|Placebo|Matched placebo
459623|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
459632|NCT00633360|B1|Baseline|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol
Drospirenone and ethinyl estradiol: Once daily by mouth"
459633|NCT00633360|P2|Participant Flow|Placebo|"Placebo
Placebo: Once daily by mouth"
459634|NCT00633360|P1|Participant Flow|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol
Drospirenone and ethinyl estradiol: Once daily by mouth"
459635|NCT00633360|O2|Outcome|Placebo|Placebo
459636|NCT00633360|O1|Outcome|Drospirenone and Ethinyl Estradiol|Drospirenone and ethinyl estradiol
459637|NCT00633360|O2|Outcome|Placebo|"Placebo
Placebo: Once daily by mouth"
459638|NCT00633360|O1|Outcome|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol
Drospirenone and ethinyl estradiol: Once daily by mouth"
459639|NCT00633360|E2|Reported Event|Placebo|"Placebo
Placebo: Once daily by mouth"
459640|NCT00633360|E1|Reported Event|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol
Drospirenone and ethinyl estradiol: Once daily by mouth"
459641|NCT00633399|B3|Baseline|Total|Total of all reporting groups
459642|NCT00633399|B2|Baseline|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
459643|NCT00633399|B1|Baseline|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
459644|NCT00633399|P2|Participant Flow|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
459645|NCT00633399|P1|Participant Flow|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
459646|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
459647|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
459648|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
459649|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
459650|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
459651|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
459652|NCT00633399|E2|Reported Event|Ziprasidone + Placebo|"Patients in group 2 will receive Placebo for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
459653|NCT00633399|E1|Reported Event|Ziprasidone + Escitalpram|"Patients in group 1 will receive Ziprasidone for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
459654|NCT00633464|B3|Baseline|Total|Total of all reporting groups
459655|NCT00633464|B2|Baseline|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
459656|NCT00633464|B1|Baseline|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
459657|NCT00633464|P2|Participant Flow|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
459658|NCT00633464|P1|Participant Flow|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
459660|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
459661|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
459662|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
459663|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
459664|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
459665|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
459666|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
459667|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
459668|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
459669|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
459670|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
459671|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
459672|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
459673|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
459674|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
459675|NCT00633464|E2|Reported Event|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
459676|NCT00633464|E1|Reported Event|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
459677|NCT00633477|B3|Baseline|Total|Total of all reporting groups
459678|NCT00633477|B2|Baseline|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
459679|NCT00633477|B1|Baseline|Resatorvid 2.4 mg/kg/Day|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours
459680|NCT00633477|P2|Participant Flow|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
459681|NCT00633477|P1|Participant Flow|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
459682|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
459683|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
459684|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
459685|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
459686|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
459687|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
459688|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
459689|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
459690|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
459691|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
459692|NCT00633477|E2|Reported Event|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
459693|NCT00633477|E1|Reported Event|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
459694|NCT00633594|B4|Baseline|Total|Total of all reporting groups
459695|NCT00633594|B3|Baseline|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
459696|NCT00633594|B2|Baseline|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
459697|NCT00633594|B1|Baseline|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14. .
459698|NCT00633594|P3|Participant Flow|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
459699|NCT00633594|P2|Participant Flow|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
459775|NCT00633893|B2|Baseline|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459776|NCT00633893|B1|Baseline|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459700|NCT00633594|P1|Participant Flow|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1-14.
459701|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.
Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
459702|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.
Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
459703|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
459793|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
467409|NCT00654498|O2|Outcome|Placebo|
459704|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15mg PO daily on Days 1-14.
Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
459705|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.
Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
459706|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.
Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
459707|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
459708|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.
Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
459709|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.
Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
459710|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.
Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
459711|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
459712|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15mg PO daily on Days 1-14.
Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
459713|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.
Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
459714|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.
Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
459715|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
459743|NCT00633880|B2|Baseline|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459744|NCT00633880|B1|Baseline|Not Randomized|Entered open-label droxidopa dose titration, but did not randomize
459716|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.
Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
459717|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.
Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
459718|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.
Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
459750|NCT00633880|O2|Outcome|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459719|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
459720|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.
Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
459721|NCT00633594|O1|Outcome|Phase II - Lenalidomide 10mg PO QD|Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 IV Days 1, 4, 8, and 11 for Cycles 1-6
459722|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.
Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
459723|NCT00633594|E3|Reported Event|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
459724|NCT00633594|E2|Reported Event|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
459725|NCT00633594|E1|Reported Event|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14.
459726|NCT00633750|B1|Baseline|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
459727|NCT00633750|P1|Participant Flow|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
459728|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants have their blood drawn and then undergo surgical resection of their tumor.
459729|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
459730|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
459731|NCT00633750|E1|Reported Event|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
459732|NCT00633867|B3|Baseline|Total|Total of all reporting groups
459733|NCT00633867|B2|Baseline|Macintosh|Tracheal intubation using Macintosh Laryngoscope
459734|NCT00633867|B1|Baseline|McGrath|Tracheal Intubation using McGrath video-laryngoscope
459735|NCT00633867|P2|Participant Flow|Macintosh|Tracheal intubation using Macintosh Laryngoscope
459736|NCT00633867|P1|Participant Flow|McGrath|Tracheal Intubation using McGrath video-laryngoscope
459737|NCT00633867|O2|Outcome|Macintosh|Tracheal intubation using Macintosh Laryngoscope
459738|NCT00633867|O1|Outcome|McGrath|Tracheal Intubation using McGrath video-laryngoscope
459739|NCT00633867|E2|Reported Event|Macintosh|Tracheal intubation using Macintosh Laryngoscope
459740|NCT00633867|E1|Reported Event|McGrath|Tracheal Intubation using McGrath video-laryngoscope
459741|NCT00633880|B4|Baseline|Total|Total of all reporting groups
459742|NCT00633880|B3|Baseline|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459773|NCT00633893|B4|Baseline|Total|Total of all reporting groups
459774|NCT00633893|B3|Baseline|Placebo|Participants received matching placebo oral tablet BID.
459745|NCT00633880|P3|Participant Flow|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459746|NCT00633880|P2|Participant Flow|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459747|NCT00633880|P1|Participant Flow|Open Label Titration|All patients titrated to their optimal dose of droxidopa during an initial open label phase for 7-14 days
459748|NCT00633880|O2|Outcome|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459749|NCT00633880|O1|Outcome|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459862|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
459751|NCT00633880|O1|Outcome|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459752|NCT00633880|O2|Outcome|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459753|NCT00633880|O1|Outcome|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459754|NCT00633880|O2|Outcome|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459755|NCT00633880|O1|Outcome|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459756|NCT00633880|O2|Outcome|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459757|NCT00633880|O1|Outcome|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459758|NCT00633880|O2|Outcome|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459759|NCT00633880|O1|Outcome|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459760|NCT00633880|O2|Outcome|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459761|NCT00633880|O1|Outcome|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459762|NCT00633880|O2|Outcome|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459763|NCT00633880|O1|Outcome|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459764|NCT00633880|O2|Outcome|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459765|NCT00633880|O1|Outcome|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459766|NCT00633880|O2|Outcome|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459767|NCT00633880|O1|Outcome|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459768|NCT00633880|O2|Outcome|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459769|NCT00633880|O1|Outcome|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459770|NCT00633880|E3|Reported Event|Open Label Phase|All patient titrated on droxidopa during open-label phase
459771|NCT00633880|E2|Reported Event|Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459772|NCT00633880|E1|Reported Event|Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
459777|NCT00633893|P3|Participant Flow|Placebo|Participants received matching placebo oral tablet BID.
459778|NCT00633893|P2|Participant Flow|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459779|NCT00633893|P1|Participant Flow|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban twice a day (BID)
459780|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459781|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459782|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459783|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459784|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459785|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459786|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459787|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459788|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459789|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459794|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459795|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459796|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459797|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459798|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459799|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459800|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459801|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459802|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459803|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459804|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459805|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459806|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459807|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459808|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459809|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459810|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459811|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459812|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459813|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459814|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459815|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459816|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459817|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459818|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459819|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459820|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459821|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459822|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459823|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459824|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459825|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459826|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459827|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459828|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459829|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459830|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459831|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459832|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459833|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459834|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459835|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459836|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459837|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459838|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459839|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459840|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459841|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459842|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459843|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
459844|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
459845|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
459846|NCT00633893|E3|Reported Event|Placebo|Participants received oral tablet of placebo BID
459847|NCT00633893|E2|Reported Event|Apixaban 5mg|Participants received 5 mg oral tablet apixaban BID
459848|NCT00633893|E1|Reported Event|Apixaban 2.5mg|Participants received 2.5 mg oral tablet apixaban BID
459849|NCT00633919|B3|Baseline|Total|Total of all reporting groups
459850|NCT00633919|B2|Baseline|Placebo|SLITone Placebo
459851|NCT00633919|B1|Baseline|Active|SLITone Dermatophagoides Mix
459852|NCT00633919|P2|Participant Flow|Placebo|SLITone Placebo
459853|NCT00633919|P1|Participant Flow|Active|SLITone Dermatophagoides Mix
459854|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
459855|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
459856|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
459857|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
459858|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
459859|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
459860|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
459861|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
459863|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
459864|NCT00633919|E2|Reported Event|Placebo|SLITone Placebo
459865|NCT00633919|E1|Reported Event|Active|SLITone Dermatophagoides Mix
459866|NCT00633932|B4|Baseline|Total|Total of all reporting groups
459867|NCT00633932|B3|Baseline|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
459868|NCT00633932|B2|Baseline|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
459869|NCT00633932|B1|Baseline|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
459870|NCT00633932|P3|Participant Flow|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
459871|NCT00633932|P2|Participant Flow|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
459872|NCT00633932|P1|Participant Flow|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
459873|NCT00633932|O3|Outcome|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
459874|NCT00633932|O2|Outcome|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
459875|NCT00633932|O1|Outcome|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
459876|NCT00633932|O3|Outcome|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
459877|NCT00633932|O2|Outcome|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
459878|NCT00633932|O1|Outcome|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
459879|NCT00633932|E3|Reported Event|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
459880|NCT00633932|E2|Reported Event|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
459881|NCT00633932|E1|Reported Event|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
459882|NCT00633984|B3|Baseline|Total|Total of all reporting groups
459883|NCT00633984|B2|Baseline|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
459884|NCT00633984|B1|Baseline|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
459885|NCT00633984|P2|Participant Flow|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
459886|NCT00633984|P1|Participant Flow|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
459887|NCT00633984|O2|Outcome|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
459888|NCT00633984|O1|Outcome|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
459889|NCT00633984|O2|Outcome|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
459890|NCT00633984|O1|Outcome|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
459891|NCT00633984|E2|Reported Event|Cognitive Behavioral Therapy + Placebo|Participants received Cognitive Behavioral Group Therapy and Placebo.
459892|NCT00633984|E1|Reported Event|Cognitive Behavioral Therapy + DCS|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
459893|NCT00634010|B3|Baseline|Total|Total of all reporting groups
459894|NCT00634010|B2|Baseline|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
459895|NCT00634010|B1|Baseline|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
459896|NCT00634010|P2|Participant Flow|Methadone Capsule|Methadone 5 mg orally every 12 hours and 5 mg immediate-release (IR) Morphine every 2 hours as needed for rescue pain (for first week).
459897|NCT00634010|P1|Participant Flow|Morphine Capsule|Morphine 5 mg slow release morphine orally every 12 hours and 5 mg immediate-release morphine every 2 hours as needed for breakthrough pain.
459898|NCT00634010|O2|Outcome|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
459899|NCT00634010|O1|Outcome|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
459900|NCT00634010|E2|Reported Event|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
459901|NCT00634010|E1|Reported Event|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
459902|NCT00634036|B3|Baseline|Total|Total of all reporting groups
466082|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
459903|NCT00634036|B2|Baseline|Placebo|placebo: matching placebo (inert tablet)
459904|NCT00634036|B1|Baseline|Pioglitazone|pioglitazone: pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
459905|NCT00634036|P2|Participant Flow|Placebo|matching placebo (inert tablet)
459906|NCT00634036|P1|Participant Flow|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
459907|NCT00634036|O2|Outcome|Placebo|matching placebo (inert tablet)
459908|NCT00634036|O1|Outcome|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
459909|NCT00634036|O2|Outcome|Placebo|matching placebo (inert tablet)
459910|NCT00634036|O1|Outcome|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
459911|NCT00634036|O2|Outcome|Placebo|matching placebo (inert tablet)
459912|NCT00634036|O1|Outcome|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
459913|NCT00634036|O2|Outcome|Placebo|matching placebo (inert tablet)
459914|NCT00634036|O1|Outcome|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
459915|NCT00634036|E2|Reported Event|Placebo|matching placebo (inert tablet)
459916|NCT00634036|E1|Reported Event|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
460060|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
460061|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
459917|NCT00634049|B1|Baseline|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) [or per os (PO)] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
459918|NCT00634049|P1|Participant Flow|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) [or per os (PO)] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
459919|NCT00634049|O1|Outcome|Isavuconazole|Participants received Isavuconazole intravenous (IV) or per oral (PO) over period of 2 days, on days 1 and 2 three doses of 200 mg were administered every 8 hours for a total of six doses. From Day 3 to End of Treatment (EOT) maintenance dose of 200 mg isavuconazole was administered once daily up to 180 days; with an option for extended treatment under specified criteria.
459920|NCT00634049|O2|Outcome|Not Renally Impaired|Not Renally Impaired (NRI) population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
459921|NCT00634049|O1|Outcome|Renally Impaired|Renally Impaired (RI) population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. Renal impairment was defined as yes for participants who had a baseline eGFR-MDRD < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
459922|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
459923|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
459924|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
459925|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
459926|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
459927|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
459928|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
459929|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
460541|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
459930|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
459931|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
459932|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
459933|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
459934|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
459935|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
459936|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
459937|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
459938|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
459939|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
459940|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
459941|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
459942|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
459943|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
459944|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
459945|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
459946|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
460104|NCT00634270|B2|Baseline|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
459947|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
459948|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
459949|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
459999|NCT00634088|P4|Participant Flow|Ixabepilone+ Lapatinib + Capecitabine|A triplet combination of ixabepilone, lapatinib, and capecitabine was planned for analysis in escalating doses but was not initiated due to premature termination of the study.
459950|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
459951|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
459952|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT population consisted of 15 participants who have had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
459953|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other Non Candida Yeast mITT population consisted of 11 participants who have had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus NOS and 2 Trichosporon).
459954|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who have had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes,9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
459955|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
459956|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who have had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium,2 Exophiala,2 Cladosporium,2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia,Exserohilum, Paecilomyces,Pseudallescheria and Scedosporium).
459957|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales – Intolerant mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
459958|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales – Refractory Therapy mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
459959|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales – Primary Therapy mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
459960|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Overall there were 24 participants in the mITTAspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
459961|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Renal impairment was defined as yes for participants who have a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
460391|NCT00626210|E1|Reported Event|Modafinil|
459962|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT population consisted of 15 participants who have had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
459963|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
459964|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
459965|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
459966|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
460053|NCT00634114|B3|Baseline|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
467410|NCT00654498|O1|Outcome|Pramipexole|
459967|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
459968|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
459969|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
459970|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
459971|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Renal impairment was defined as yes for participants who have a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
459972|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
459973|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
459974|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
459975|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
459976|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
459977|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
459978|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
459996|NCT00634088|B3|Baseline|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg), lapatinib 1250 mg administered orally once a day, every day for 7 to 14 consecutive days prior to the first administration of ixabepilone in Cycle 1. Then lapatinib administered daily, orally once a day, for a 21-day cycle. Ixabepilone administered as a 3-hour IV infusion of 40 mg/m^2 following lapatinib lead-in period.
459979|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
459980|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
460054|NCT00634114|B2|Baseline|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
460055|NCT00634114|B1|Baseline|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
460056|NCT00634114|P3|Participant Flow|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
459981|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired or not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
459982|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
459983|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
459984|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
459985|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
459986|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
459987|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
459988|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
459989|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
459990|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
459991|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
459992|NCT00634049|E2|Reported Event|Not Renally Impaired (NRI)|"Not Renally impaired participants were defined as no if they have a baseline eGFR-MDRD
≥ 60 mL/min/1.73 m^2 by the Modification of Diet in Renal Disease (MDRD) formula."
459993|NCT00634049|E1|Reported Event|Renally Impaired (RI)|Renal impairment was defined as yes for participants who have a baseline as eGFR < 60 mL/min/1.73 m^2 by the Modification of Diet in Renal Disease (MDRD) formula.
459994|NCT00634088|B5|Baseline|Total|Total of all reporting groups
459995|NCT00634088|B4|Baseline|Ixabepilone + Lapatinib + Capecitabine|A triplet combination of ixabepilone, lapatinib, and capecitabine was planned for analysis in escalating doses but was not initiated due to premature termination of the study.
460032|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
459997|NCT00634088|B2|Baseline|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg), lapatinib 1250 mg administered orally once a day, every day, for 7 to 14 consecutive days prior to the first administration of ixabepilone. Then lapatinib administered orally once a day, every day, for a 21-day cycle. After lapatinib lead-in period, ixabepilone administered as a 3-hour IV infusion of 32 mg/m^2.
459998|NCT00634088|B1|Baseline|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib administered daily in escalating cohorts, beginning with 1000 mg, orally once a day, for 7 to 14 consecutive days in Cycle 1 prior to the first administration of ixabepilone. Then lapatinib administered daily, orally once a day, for a 21-day cycle. After the lapatinib lead-in phase, ixabepilone administered as a 3-hour IV infusion in escalating doses, beginning with 32 mg/m^2.
460057|NCT00634114|P2|Participant Flow|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
467411|NCT00654498|O2|Outcome|Placebo|
460000|NCT00634088|P3|Participant Flow|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered daily, orally once a day, for 7 to 14 consecutive days prior to the first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
460001|NCT00634088|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered daily, orally once a day, for 7 to 14 consecutive days prior to the first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
460002|NCT00634088|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib, 1000 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
460003|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
460004|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460005|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460006|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
460007|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
460008|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460009|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460010|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
460011|NCT00634088|O1|Outcome|All Treated|All participants who received at least 1 dose of ixabepilone or lapatinib.
460012|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
460013|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460014|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460015|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
460016|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
460017|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460018|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460019|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
460020|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
460021|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460022|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460023|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
460024|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
460025|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460026|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460027|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
460028|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
460029|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460030|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460031|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
460642|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
460033|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460034|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460058|NCT00634114|P1|Participant Flow|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
460059|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
461337|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
460035|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
460036|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
460037|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460038|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460039|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
460040|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
460041|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460042|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460043|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
460044|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
460045|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460046|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
460047|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
460048|NCT00634088|O1|Outcome|All Treated|All participants who received at least 1 dose of ixabepilone or lapatinib.
460049|NCT00634088|E3|Reported Event|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for 21-day cycle.
460100|NCT00634244|E3|Reported Event|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
460050|NCT00634088|E2|Reported Event|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for 21-day cycle.
460051|NCT00634088|E1|Reported Event|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for 21-day cycle.
460052|NCT00634114|B4|Baseline|Total|Total of all reporting groups
461338|NCT00629239|O2|Outcome|Placebo|Placebo
460062|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
460063|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
460064|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
460065|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
460066|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
460067|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
460068|NCT00634114|E3|Reported Event|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
460069|NCT00634114|E2|Reported Event|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
460070|NCT00634114|E1|Reported Event|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
460071|NCT00634166|B3|Baseline|Total|Total of all reporting groups
460072|NCT00634166|B2|Baseline|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).
Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
460073|NCT00634166|B1|Baseline|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)
Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
460074|NCT00634166|P2|Participant Flow|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).
Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
460075|NCT00634166|P1|Participant Flow|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)
Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
460076|NCT00634166|O2|Outcome|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).
Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
460077|NCT00634166|O1|Outcome|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)
Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
460078|NCT00634166|E2|Reported Event|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).
Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
460101|NCT00634244|E2|Reported Event|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
460079|NCT00634166|E1|Reported Event|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)
Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
460080|NCT00634179|B1|Baseline|Treatment (VR-CHOP Regimen)|"INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity."
460081|NCT00634179|P1|Participant Flow|Treatment (VR-CHOP Regimen)|"Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy regimen.
In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-cell non-Hodgkin's lymphoma (B-NHL)(Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma."
461339|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
460082|NCT00634179|O2|Outcome|Phase II: Maintenance|"INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
MAINTENANCE: Patients achieving CR receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or PR receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
Bortezomib: Bortezomib 1.6 mg/m² given on days 1 and 8
Rituximab: Rituximab 375 mg/m²
Doxorubicin: Doxorubicin 50 mg/m²
Cyclophosphamide: Cyclophosphamide 750 mg/m²
Vincristine: Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1
Prednisone: Prednisone 100 mg/day given orally on"
460083|NCT00634179|O1|Outcome|Phase I: Induction|INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
460084|NCT00634179|O1|Outcome|MTD of Bortezomib With Vincristine Capped at 1.5 mg|Maximal tolerated dose (MTD) of bortezomib when vincristine is capped at 1.5 mg
460085|NCT00634179|E2|Reported Event|Phase II: Maintenance|In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-NHL. (Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma.
460086|NCT00634179|E1|Reported Event|Phase I: Induction|Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the CHOP chemotherapy regimen.
460087|NCT00634244|B4|Baseline|Total|Total of all reporting groups
460088|NCT00634244|B3|Baseline|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
460089|NCT00634244|B2|Baseline|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
460090|NCT00634244|B1|Baseline|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
460091|NCT00634244|P3|Participant Flow|Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus)|"Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
sirolimus: Given PO
etoposide: Given IV"
460092|NCT00634244|P2|Participant Flow|Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine)|"Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV"
460093|NCT00634244|P1|Participant Flow|Arm A (Carboplatin and Topotecan Hydrochloride)|"Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
carboplatin: Given IV
topotecan hydrochloride: Given IV"
460094|NCT00634244|O3|Outcome|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
460095|NCT00634244|O2|Outcome|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
460096|NCT00634244|O1|Outcome|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
460097|NCT00634244|O3|Outcome|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
460098|NCT00634244|O2|Outcome|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
460099|NCT00634244|O1|Outcome|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
460102|NCT00634244|E1|Reported Event|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
460105|NCT00634270|B1|Baseline|Stratum 1|"Design
Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.
Disease status will be evaluated using volumetric MRI analysis at regular intervals.
Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
460106|NCT00634270|P2|Participant Flow|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
460107|NCT00634270|P1|Participant Flow|Stratum 1|"Design
Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.
Disease status will be evaluated using volumetric MRI analysis at regular intervals.
Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
460148|NCT00634504|O2|Outcome|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase
high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
460550|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
460108|NCT00634270|O1|Outcome|Stratum 1|"Design
• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.
Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
460109|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
460110|NCT00634270|O1|Outcome|Stratum 1|"Design
Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.
Disease status will be evaluated using volumetric MRI analysis at regular intervals.
Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
460111|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
460112|NCT00634270|O1|Outcome|Stratum 1|"Design
Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.
Disease status will be evaluated using volumetric MRI analysis at regular intervals.
Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
460113|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
460114|NCT00634270|O1|Outcome|Stratum 1|"Design
Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.
Disease status will be evaluated using volumetric MRI analysis at regular intervals.
Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
460115|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
460116|NCT00634270|O1|Outcome|Stratum 1|"Design
Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.
Disease status will be evaluated using volumetric MRI analysis at regular intervals.
Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
460117|NCT00634270|O1|Outcome|Stratum 1|"Design
• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.
Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
460118|NCT00634270|O1|Outcome|Stratum 1|"Design
• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.
Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
460119|NCT00634270|O1|Outcome|Stratum 1|"Design
• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.
Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
460120|NCT00634270|O1|Outcome|Stratum 1|"Design
• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
460551|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
461340|NCT00629239|O2|Outcome|Placebo|Placebo
460121|NCT00634270|O1|Outcome|Stratum 1|"Design
• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
460122|NCT00634270|O1|Outcome|Stratum 1|"Design
• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing."
460123|NCT00634270|O2|Outcome|Stratum 2|Patients ≥ 3 years old and plexiform neurofibroma(s) without documented radiographic progression at trial entry. The endpoint will be radiographic response.
460124|NCT00634270|O1|Outcome|Stratum 1|Patients ≥ 3 years old with progressive plexiform neurofibroma(s) with the potential to cause significant morbidity.
460125|NCT00634270|O1|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
460126|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
460127|NCT00634270|O1|Outcome|Stratum 1|"Design
Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.
Disease status will be evaluated using volumetric MRI analysis at regular intervals.
Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
460128|NCT00634270|E2|Reported Event|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
460129|NCT00634270|E1|Reported Event|Stratum 1|"Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity with evidence of progression.
Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Disease status will be evaluated using volumetric MRI analysis at regular intervals."
460130|NCT00634322|B4|Baseline|Total|Total of all reporting groups
460131|NCT00634322|B3|Baseline|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
460132|NCT00634322|B2|Baseline|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
460133|NCT00634322|B1|Baseline|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
460134|NCT00634322|P3|Participant Flow|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
460135|NCT00634322|P2|Participant Flow|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
460136|NCT00634322|P1|Participant Flow|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
460137|NCT00634322|O3|Outcome|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
460138|NCT00634322|O2|Outcome|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
460139|NCT00634322|O1|Outcome|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
460140|NCT00634322|E3|Reported Event|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
460141|NCT00634322|E2|Reported Event|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
460142|NCT00634322|E1|Reported Event|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
460143|NCT00634504|B3|Baseline|Total|Total of all reporting groups
460144|NCT00634504|B2|Baseline|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase
high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
460145|NCT00634504|B1|Baseline|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase
glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
460146|NCT00634504|P2|Participant Flow|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase
high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
460147|NCT00634504|P1|Participant Flow|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase
glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
460552|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
460149|NCT00634504|O1|Outcome|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase
glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
460150|NCT00634504|E2|Reported Event|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase
high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
460151|NCT00634504|E1|Reported Event|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase
glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
460152|NCT00634543|B3|Baseline|Total|Total of all reporting groups
460153|NCT00634543|B2|Baseline|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460154|NCT00634543|B1|Baseline|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460155|NCT00634543|P2|Participant Flow|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460156|NCT00634543|P1|Participant Flow|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460157|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460158|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460159|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460160|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460161|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460162|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460163|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460436|NCT00626275|E3|Reported Event|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460164|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460165|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460166|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460446|NCT00626327|O3|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
467412|NCT00654498|O1|Outcome|Pramipexole|
460167|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460168|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460169|NCT00634543|E2|Reported Event|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460170|NCT00634543|E1|Reported Event|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
460171|NCT00634569|B3|Baseline|Total|Total of all reporting groups
460172|NCT00634569|B2|Baseline|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
460173|NCT00634569|B1|Baseline|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
460174|NCT00634569|P2|Participant Flow|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
460175|NCT00634569|P1|Participant Flow|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
460176|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
460177|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
460178|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
460179|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
460180|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
460181|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
460182|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
460183|NCT00634569|O2|Outcome|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
460184|NCT00634569|O1|Outcome|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
460185|NCT00634569|E1|Reported Event|All Subjects|Intent-to-treat population
460186|NCT00634582|B1|Baseline|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
460187|NCT00634582|P1|Participant Flow|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
460188|NCT00634582|O1|Outcome|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
460189|NCT00634582|E1|Reported Event|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
460190|NCT00634621|B1|Baseline|Hexvix|Use of the Hexvix drug.
460191|NCT00634621|P1|Participant Flow|Hexvix 2 mg/mL Infusion|Administrtation of 2 mg/mL Hexvix.
460192|NCT00634621|O1|Outcome|Confirmed Bladder Cancer by Standard of Truth|Using the Hexvix drug with a cystoscopy technique of White-light cystoscopy and Blue-light cystoscopy.
460193|NCT00634621|O4|Outcome|Multiple Normalized Biopsy|Only Multiple Normalized Biopsy.
460194|NCT00634621|O3|Outcome|Blue-light Cystoscopy Only|Hexvix administered using only Blue-light Cystoscopy.
460195|NCT00634621|O2|Outcome|White-light Cystoscopy Only|Hexvix administered using only White-light Cystoscopy.
460196|NCT00634621|O1|Outcome|White-light and Blue-Light Cystoscopy Simultaneously|Hexvix administered using both White-light and Blue-Light Cystoscopy.
460197|NCT00634621|E1|Reported Event|Hexvix|Use of the Hexvix drug.
460198|NCT00634647|B1|Baseline|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
460199|NCT00634647|P1|Participant Flow|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
460200|NCT00634647|O1|Outcome|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
460201|NCT00634647|O1|Outcome|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
460202|NCT00634647|E1|Reported Event|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
460203|NCT00634751|B5|Baseline|Total|Total of all reporting groups
468658|NCT00658684|O1|Outcome|Total|All subjects
460204|NCT00634751|B4|Baseline|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
460281|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
461341|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
460205|NCT00634751|B3|Baseline|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
460206|NCT00634751|B2|Baseline|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length
Sorafenib 400 mg BID Oral Daily Every 28 days"
460207|NCT00634751|B1|Baseline|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort I
Sorafenib 200 mg BID Oral Daily Every 28 days
If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
460208|NCT00634751|P4|Participant Flow|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
460209|NCT00634751|P3|Participant Flow|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
460210|NCT00634751|P2|Participant Flow|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length
Sorafenib 400 mg BID Oral Daily Every 28 days"
460211|NCT00634751|P1|Participant Flow|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort I
Sorafenib 200 mg BID Oral Daily Every 28 days
If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
460212|NCT00634751|O4|Outcome|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
460213|NCT00634751|O3|Outcome|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
460447|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
460214|NCT00634751|O2|Outcome|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length
Sorafenib 400 mg BID Oral Daily Every 28 days"
460215|NCT00634751|O1|Outcome|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort I
Sorafenib 200 mg BID Oral Daily Every 28 days
If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
460216|NCT00634751|O4|Outcome|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
460217|NCT00634751|O3|Outcome|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
460218|NCT00634751|O2|Outcome|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length
Sorafenib 400 mg BID Oral Daily Every 28 days"
460219|NCT00634751|O1|Outcome|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort I
Sorafenib 200 mg BID Oral Daily Every 28 days
If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
460220|NCT00634751|O4|Outcome|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
460221|NCT00634751|O3|Outcome|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
460392|NCT00626275|B1|Baseline|All Treated Participants|All participants who received at least 1 dose of study drug during any sequence of Part A of the study. Baseline measures reported in aggregate for all participants to avoid double counting of Parts A and B.
460643|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
460246|NCT00634907|P2|Participant Flow|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
460222|NCT00634751|O2|Outcome|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length
Sorafenib 400 mg BID Oral Daily Every 28 days"
460223|NCT00634751|O1|Outcome|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort I
Sorafenib 200 mg BID Oral Daily Every 28 days
If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
460224|NCT00634751|E4|Reported Event|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
460225|NCT00634751|E3|Reported Event|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
460226|NCT00634751|E2|Reported Event|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length
Sorafenib 400 mg BID Oral Daily Every 28 days"
460227|NCT00634751|E1|Reported Event|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib
Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.
Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.
Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.
Cohort I
Sorafenib 200 mg BID Oral Daily Every 28 days
If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
460228|NCT00634842|B3|Baseline|Total|Total of all reporting groups
460229|NCT00634842|B2|Baseline|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
460230|NCT00634842|B1|Baseline|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
460231|NCT00634842|P2|Participant Flow|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
460232|NCT00634842|P1|Participant Flow|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
460233|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
460234|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
460235|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
460236|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
460237|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
460238|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
460239|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
460240|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
460241|NCT00634842|E2|Reported Event|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
460242|NCT00634842|E1|Reported Event|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
460243|NCT00634907|B3|Baseline|Total|Total of all reporting groups
460244|NCT00634907|B2|Baseline|Control Arm|Standard of care dosing
460245|NCT00634907|B1|Baseline|Genotype-Based Dosing Arm|Initial warfarin dose calculated according to published Sconce algorithm
460644|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
467413|NCT00654498|O2|Outcome|Placebo|
460247|NCT00634907|P1|Participant Flow|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:
Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
460248|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
460249|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:
Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
460250|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
460251|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:
Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
460252|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
460253|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:
Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
460254|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
460255|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:
Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
460393|NCT00626275|P8|Participant Flow|Part B: Placebo|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
468989|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
460256|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
460257|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:
Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
460258|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
460259|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:
Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
460260|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
460261|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:
Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
460262|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
460263|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:
Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
460264|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
460265|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:
Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
460394|NCT00626275|P7|Participant Flow|Part B: ADL5859 100 mg|ADL5859: 100 mg, capsules, administered orally, twice daily (BID) for 2 weeks during Part B of the study
460266|NCT00634907|E2|Reported Event|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
467414|NCT00654498|O1|Outcome|Pramipexole|
460267|NCT00634907|E1|Reported Event|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:
Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
460268|NCT00634920|B4|Baseline|Total|Total of all reporting groups
460269|NCT00634920|B3|Baseline|Not Randomized Patients|This group included patients in whom a renal TX was performed but who did not qualify for randomization at Visit 2. This group was to be described with respect to treatment, reason for not randomized and outcome variables calculated or measured GFR, whichever was feasible, BPAR, graft loss or death at 12 months (no outcome variables were collected for this population
460270|NCT00634920|B2|Baseline|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460271|NCT00634920|B1|Baseline|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460272|NCT00634920|P3|Participant Flow|Pre-Randomized Patients|All patients received induction therapy with 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg at Day 4 post-TX (transplatation), and commenced on an immunosuppressive regimen consisting of: CsA (based on trough levels C0-h 100-250 ng/mL or C2-h 900 1300 ng/mL, according to local method), EC MPS (target dose 1440 mg/day, minimum dose 1080 mg/day at the time of randomization), Corticosteroids (a minimum dose of 10 mg prednisolone or equivalent was given at time of randomization).
460273|NCT00634920|P2|Participant Flow|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460274|NCT00634920|P1|Participant Flow|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460275|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460276|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460277|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460278|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460279|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460437|NCT00626275|E2|Reported Event|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460542|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
460280|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460553|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
460282|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460283|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460284|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460285|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460286|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460287|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460288|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460289|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460290|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460291|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460292|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460293|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460438|NCT00626275|E1|Reported Event|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
460439|NCT00626327|B4|Baseline|Total|Total of all reporting groups
460294|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460295|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460296|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460297|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460298|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460299|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460300|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460301|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460302|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460303|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460304|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460305|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460306|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460307|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460440|NCT00626327|B3|Baseline|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
468990|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
460308|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460309|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460310|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460311|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460312|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460313|NCT00634920|E2|Reported Event|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
460314|NCT00634920|E1|Reported Event|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
460315|NCT00634933|B4|Baseline|Total|Total of all reporting groups
460316|NCT00634933|B3|Baseline|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460317|NCT00634933|B2|Baseline|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460318|NCT00634933|B1|Baseline|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460319|NCT00634933|P5|Participant Flow|Placebo/TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
460320|NCT00634933|P4|Participant Flow|Placebo/TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460441|NCT00626327|B2|Baseline|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
460442|NCT00626327|B1|Baseline|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
460321|NCT00634933|P3|Participant Flow|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460549|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
460322|NCT00634933|P2|Participant Flow|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 800 mg, IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460323|NCT00634933|P1|Participant Flow|Placebo|Placebo infusion, matched to TRU-015 (800 milligram [mg]), intravenously (IV) along with methylprednisolone 100 mg IV 1 hour (hr) prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.
460324|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460325|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460326|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460327|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460328|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460395|NCT00626275|P6|Participant Flow|Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then placebo, then naproxen 500 mg).
Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose."
460345|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460329|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460330|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460331|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460332|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460333|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460334|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460335|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460336|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460423|NCT00626275|O3|Outcome|ADL5859 - 200mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460424|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460337|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460338|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460339|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460340|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460341|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460342|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460343|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460344|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460425|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
460426|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
460346|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460347|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460348|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460349|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460350|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460351|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460352|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460427|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
460428|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
468991|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
460369|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460353|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460354|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460355|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460356|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460357|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460358|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460359|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460360|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460429|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460430|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
460361|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460362|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460363|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460364|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460365|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460366|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460367|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460368|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460431|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460432|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460370|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460371|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460372|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460373|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460374|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460375|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460376|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460433|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
460434|NCT00626275|E5|Reported Event|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
468992|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
460396|NCT00626275|P5|Participant Flow|Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then naproxen 500 mg, then ADL5859 200 mg).
Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose."
461127|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
460377|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460378|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460379|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460380|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
460381|NCT00634933|E7|Reported Event|Placebo/TRU-015 Induction Dose (Part B)|TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
460382|NCT00634933|E6|Reported Event|Placebo/TRU-015 Single Dose (Part B)|TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 800 mg, IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460383|NCT00634933|E5|Reported Event|TRU-015 Induction Dose (Part B)|Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460384|NCT00634933|E4|Reported Event|TRU-015 Single Dose (Part B)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
460385|NCT00634933|E3|Reported Event|TRU-015 Induction Dose (Part A)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-ID in the Part B of the study.
460386|NCT00634933|E2|Reported Event|TRU-015 Single Dose (Part A)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-SD in the Part B of the study.
460387|NCT00634933|E1|Reported Event|Placebo (Part A)|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.
460388|NCT00626210|B1|Baseline|Modafinil|Open label study in which all participants get modafinil
460389|NCT00626210|P1|Participant Flow|Modafinil|daily 100 mg of modafinil within 1 hr of awakening for one week followed by daily 200 mg of modafinil within 1 hr of awakening for one week
460390|NCT00626210|O1|Outcome|Modafinil|
460397|NCT00626275|P4|Participant Flow|Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then ADL5859 200 mg, then placebo).
Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose."
460398|NCT00626275|P3|Participant Flow|Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then placebo, then ADL5859 200 mg).
Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose."
460399|NCT00626275|P2|Participant Flow|Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then naproxen 500 mg, then placebo).
Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose."
460400|NCT00626275|P1|Participant Flow|Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then ADL5859 200 milligrams (mg), then naproxen 500 mg).
Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose"
460401|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
460402|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
460403|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460404|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460405|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
460406|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
460407|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
460408|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
460409|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
460410|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
460411|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
460412|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
460413|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
460414|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460415|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460416|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
460417|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460418|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460419|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
460420|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460421|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
460422|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
460435|NCT00626275|E4|Reported Event|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
460443|NCT00626327|P3|Participant Flow|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
460444|NCT00626327|P2|Participant Flow|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
460445|NCT00626327|P1|Participant Flow|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
461128|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
460448|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
460449|NCT00626327|O3|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
460450|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
460451|NCT00626327|O1|Outcome|MenACWY-CRM+MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
460452|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
460453|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
460454|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
460455|NCT00626327|O1|Outcome|MenACWY-CRM +MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
460456|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
460457|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
460458|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
460459|NCT00626327|O1|Outcome|MenACWY-CRM + MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
460460|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
460461|NCT00626327|O1|Outcome|MenACWY-CRM+MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
460462|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
460463|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
460464|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
460465|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
460466|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
460467|NCT00626327|E3|Reported Event|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
460468|NCT00626327|E2|Reported Event|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
460469|NCT00626327|E1|Reported Event|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
460470|NCT00626340|B1|Baseline|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
460471|NCT00626340|P1|Participant Flow|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
460472|NCT00626340|O1|Outcome|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
460473|NCT00626340|E1|Reported Event|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
460474|NCT00626392|B7|Baseline|Total|Total of all reporting groups
460638|NCT00627094|B2|Baseline|Biatain|Biatain foam dressing without ibuprofen - control
460475|NCT00626392|B6|Baseline|NER 1000; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
460476|NCT00626392|B5|Baseline|NER 1000; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
460477|NCT00626392|B4|Baseline|NER 1000; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
461129|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
460478|NCT00626392|B3|Baseline|NER 500; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
460479|NCT00626392|B2|Baseline|NER 500; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
460480|NCT00626392|B1|Baseline|NER 500; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
460481|NCT00626392|P6|Participant Flow|NER 1000; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
460482|NCT00626392|P5|Participant Flow|NER 1000; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
460483|NCT00626392|P4|Participant Flow|NER 1000; ASA run-in; ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
460484|NCT00626392|P3|Participant Flow|NER 500; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
460485|NCT00626392|P2|Participant Flow|NER 500; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
460486|NCT00626392|P1|Participant Flow|NER 500; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
460487|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
460488|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
460489|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
460490|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
460491|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
460492|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
460493|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
460494|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
460495|NCT00626392|E2|Reported Event|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
460496|NCT00626392|E1|Reported Event|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
460497|NCT00626431|B3|Baseline|Total|Total of all reporting groups
460498|NCT00626431|B2|Baseline|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460499|NCT00626431|B1|Baseline|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460500|NCT00626431|P2|Participant Flow|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460501|NCT00626431|P1|Participant Flow|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460502|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460503|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460538|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
460539|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
460540|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
460504|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460505|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460506|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460507|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460508|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460509|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460510|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460511|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460512|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460513|NCT00626431|E2|Reported Event|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460514|NCT00626431|E1|Reported Event|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
460515|NCT00626444|B1|Baseline|Vitamin C|"Intravenous vitamin C
Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
460516|NCT00626444|P1|Participant Flow|Vitamin C|"Intravenous vitamin C
Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
460517|NCT00626444|O1|Outcome|Vitamin C|"Intravenous vitamin C
Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
460518|NCT00626444|O1|Outcome|Vitamin C|"Intravenous vitamin C
Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
460519|NCT00626444|E1|Reported Event|Vitamin C|"Intravenous vitamin C
Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
460520|NCT00626522|B7|Baseline|Total|Total of all reporting groups
460521|NCT00626522|B6|Baseline|Placebo|Placebo once-daily
460522|NCT00626522|B5|Baseline|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
460523|NCT00626522|B4|Baseline|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
460524|NCT00626522|B3|Baseline|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
460525|NCT00626522|B2|Baseline|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
460526|NCT00626522|B1|Baseline|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
460527|NCT00626522|P6|Participant Flow|Placebo|Placebo once-daily
460528|NCT00626522|P5|Participant Flow|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
460529|NCT00626522|P4|Participant Flow|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
460530|NCT00626522|P3|Participant Flow|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
460531|NCT00626522|P2|Participant Flow|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
460532|NCT00626522|P1|Participant Flow|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
460533|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
460534|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
460535|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
460536|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
460537|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
460543|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
460544|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
460545|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
460546|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
460547|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
460548|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
460554|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
460555|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
460556|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
460557|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
460558|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
460559|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
460560|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
460561|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
460562|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
460563|NCT00626522|E6|Reported Event|Placebo|Placebo once-daily
460564|NCT00626522|E5|Reported Event|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
460565|NCT00626522|E4|Reported Event|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
460566|NCT00626522|E3|Reported Event|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
460567|NCT00626522|E2|Reported Event|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
460568|NCT00626522|E1|Reported Event|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
460569|NCT00626548|B3|Baseline|Total|Total of all reporting groups
460570|NCT00626548|B2|Baseline|Placebo|Placebo oral tablet once daily
460571|NCT00626548|B1|Baseline|ZD4054|ZD4054 10 mg oral tablet once daily
460572|NCT00626548|P2|Participant Flow|Placebo|Placebo oral tablet once daily
460573|NCT00626548|P1|Participant Flow|ZD4054|ZD4054 10 mg oral tablet once daily
460574|NCT00626548|O2|Outcome|Placebo|Placebo oral tablet once daily
460575|NCT00626548|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
460576|NCT00626548|O2|Outcome|Placebo|Placebo oral tablet once daily
460577|NCT00626548|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
460578|NCT00626548|E2|Reported Event|Placebo|Placebo oral tablet once daily
460579|NCT00626548|E1|Reported Event|ZD4054|ZD4054 10 mg oral tablet once daily
460580|NCT00626561|B1|Baseline|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
460581|NCT00626561|P1|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
460582|NCT00626561|O1|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
460583|NCT00626561|E1|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
460584|NCT00626574|B3|Baseline|Total|Total of all reporting groups
460585|NCT00626574|B2|Baseline|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
460586|NCT00626574|B1|Baseline|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
460587|NCT00626574|P2|Participant Flow|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
460588|NCT00626574|P1|Participant Flow|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
460589|NCT00626574|O2|Outcome|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
460590|NCT00626574|O1|Outcome|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
460591|NCT00626574|E2|Reported Event|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
460592|NCT00626574|E1|Reported Event|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
460593|NCT00626639|B3|Baseline|Total|Total of all reporting groups
468993|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
460594|NCT00626639|B2|Baseline|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460595|NCT00626639|B1|Baseline|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460655|NCT00627393|P2|Participant Flow|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
460656|NCT00627393|P1|Participant Flow|Control Arm|Received antimicrobial therapy alone.
461130|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
460596|NCT00626639|P2|Participant Flow|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460597|NCT00626639|P1|Participant Flow|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460598|NCT00626639|O2|Outcome|Palifermin|Subjects who received Palifermin during the acute phase of the study.
460599|NCT00626639|O1|Outcome|Placebo|Subjects who received placebo during the acute phase of the study.
460600|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460601|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460602|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460603|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460604|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460605|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460606|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460607|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460608|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460639|NCT00627094|B1|Baseline|Biatain Ibu|Biatain foam dressing containing ibuprofen
460640|NCT00627094|P2|Participant Flow|Biatain|Biatain Foam dressing without ibuprofen - control
460641|NCT00627094|P1|Participant Flow|Biatain Ibu|Biatain foam dressing containing Ibuprofen
460609|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460610|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460611|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460612|NCT00626639|E2|Reported Event|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460613|NCT00626639|E1|Reported Event|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
460614|NCT00627016|B3|Baseline|Total|Total of all reporting groups
460615|NCT00627016|B2|Baseline|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
460616|NCT00627016|B1|Baseline|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
460617|NCT00627016|P2|Participant Flow|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
460618|NCT00627016|P1|Participant Flow|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
460619|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
460620|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
460621|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
460622|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
460623|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
460624|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
460625|NCT00627016|E2|Reported Event|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
460626|NCT00627016|E1|Reported Event|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
460627|NCT00627042|B1|Baseline|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
460628|NCT00627042|P1|Participant Flow|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
460629|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
460630|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
460631|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
460632|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
460633|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
460634|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
460635|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
460636|NCT00627042|E1|Reported Event|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
460637|NCT00627094|B3|Baseline|Total|Total of all reporting groups
460645|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
460646|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
460647|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
460648|NCT00627094|O2|Outcome|Biatain|Biatain foam dressing without ibuprofen - control
460649|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing ibuprofen
460650|NCT00627094|E2|Reported Event|Biatain|Biatain foam dressing without ibuprofen
460651|NCT00627094|E1|Reported Event|Biatain Ibu|Biatain foam dressing containing ibuprofen
460652|NCT00627393|B3|Baseline|Total|Total of all reporting groups
460653|NCT00627393|B2|Baseline|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
460654|NCT00627393|B1|Baseline|Control Arm|Received antimicrobial therapy alone.
460657|NCT00627393|O1|Outcome|Granulocyte Donors|"Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone
G-CSF/dexamethasone: Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.
Apheresis machine: Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants."
460658|NCT00627393|O1|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
460659|NCT00627393|O1|Outcome|Granulocyte Donors|"Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone
G-CSF/dexamethasone: Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.
Apheresis machine: Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants."
460660|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
460661|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
460662|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
460663|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
460664|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
460665|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
460666|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
460667|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
460668|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
460669|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
460670|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
460671|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
460672|NCT00627393|E2|Reported Event|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
460673|NCT00627393|E1|Reported Event|Control Arm|Received antimicrobial therapy alone.
460674|NCT00627406|B5|Baseline|Total|Total of all reporting groups
460675|NCT00627406|B4|Baseline|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
Pregnyl : Subcutaneous injection 5000 IU"
460676|NCT00627406|B3|Baseline|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)
Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
460677|NCT00627406|B2|Baseline|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
Pregnyl : Subcutaneous injection 5000 IU"
460678|NCT00627406|B1|Baseline|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)
Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
460679|NCT00627406|P4|Participant Flow|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
Pregnyl : Subcutaneous injection 5000 IU"
460680|NCT00627406|P3|Participant Flow|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)
Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
460681|NCT00627406|P2|Participant Flow|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
Pregnyl : Subcutaneous injection 5000 IU"
460682|NCT00627406|P1|Participant Flow|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)
Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
460683|NCT00627406|O4|Outcome|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
Pregnyl : Subcutaneous injection 5000 IU"
460810|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
468994|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
460684|NCT00627406|O3|Outcome|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)
Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
460685|NCT00627406|O2|Outcome|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
Pregnyl : Subcutaneous injection 5000 IU"
460686|NCT00627406|O1|Outcome|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)
Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
460687|NCT00627406|O4|Outcome|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
Pregnyl : Subcutaneous injection 5000 IU"
460816|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
461342|NCT00629239|O2|Outcome|Placebo|Placebo
460688|NCT00627406|O3|Outcome|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)
Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
460689|NCT00627406|O2|Outcome|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
Pregnyl : Subcutaneous injection 5000 IU"
460690|NCT00627406|O1|Outcome|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)
Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
460691|NCT00627406|E4|Reported Event|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
Pregnyl : Subcutaneous injection 5000 IU"
460692|NCT00627406|E3|Reported Event|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)
Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
460693|NCT00627406|E2|Reported Event|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
Pregnyl : Subcutaneous injection 5000 IU"
460694|NCT00627406|E1|Reported Event|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)
Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
460695|NCT00627445|B3|Baseline|Total|Total of all reporting groups
460696|NCT00627445|B2|Baseline|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
460697|NCT00627445|B1|Baseline|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
460698|NCT00627445|P2|Participant Flow|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
460699|NCT00627445|P1|Participant Flow|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
460700|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
460701|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
460702|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
460703|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
460704|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
460705|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
460706|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
460707|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
460708|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
460709|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
460710|NCT00627445|O2|Outcome|BIAsp 30-30|Individually adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin (500-2000 mg up to three times daily)
460711|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individually adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch in combination with metformin (500-2000 mg up to three times daily)
460712|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
468995|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
460713|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
460714|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
460715|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
460716|NCT00627445|E2|Reported Event|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
461131|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
460717|NCT00627445|E1|Reported Event|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
460718|NCT00627458|B4|Baseline|Total|Total of all reporting groups
460719|NCT00627458|B3|Baseline|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460720|NCT00627458|B2|Baseline|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460721|NCT00627458|B1|Baseline|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460722|NCT00627458|P3|Participant Flow|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460723|NCT00627458|P2|Participant Flow|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460724|NCT00627458|P1|Participant Flow|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460725|NCT00627458|O3|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460726|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460727|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460728|NCT00627458|O3|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460729|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460730|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460731|NCT00627458|O3|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460732|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
468996|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
460733|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460734|NCT00627458|O3|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460817|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460735|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460736|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460737|NCT00627458|O3|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460738|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460739|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460740|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460741|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460742|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460743|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460744|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460745|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460746|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460747|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460748|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460749|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460811|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460812|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460750|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460751|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460752|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460753|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460754|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460755|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460756|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460757|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460758|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460759|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460760|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460761|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460762|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460763|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460764|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460765|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460766|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460813|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460767|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460818|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460819|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
461343|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
460768|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460769|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460770|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460771|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460772|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460773|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460774|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460775|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460776|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460777|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460778|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460779|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460780|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460781|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460782|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460783|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460861|NCT00627523|B3|Baseline|Total|Total of all reporting groups
460784|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460785|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460786|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460787|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460788|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460789|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460790|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460791|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460792|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460793|NCT00627458|E3|Reported Event|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460794|NCT00627458|E2|Reported Event|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460795|NCT00627458|E1|Reported Event|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
460796|NCT00627497|B5|Baseline|Total|Total of all reporting groups
460797|NCT00627497|B4|Baseline|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460798|NCT00627497|B3|Baseline|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460799|NCT00627497|B2|Baseline|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460800|NCT00627497|B1|Baseline|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460801|NCT00627497|P4|Participant Flow|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460802|NCT00627497|P3|Participant Flow|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460803|NCT00627497|P2|Participant Flow|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460804|NCT00627497|P1|Participant Flow|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460805|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460806|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460807|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460808|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460809|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460862|NCT00627523|B2|Baseline|Control|This group was the untreated control group and was not administered placebo.
460814|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460815|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
461134|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
460820|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460821|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460822|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460823|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460824|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460825|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460826|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460827|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460828|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460829|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460830|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460831|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460832|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460833|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460834|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460835|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460836|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460837|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460838|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460839|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460840|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460841|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460842|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460843|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460844|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460845|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460846|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460847|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460848|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460849|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460850|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460851|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460852|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460853|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460854|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460855|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460856|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460857|NCT00627497|E4|Reported Event|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
460858|NCT00627497|E3|Reported Event|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460859|NCT00627497|E2|Reported Event|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
460860|NCT00627497|E1|Reported Event|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
460863|NCT00627523|B1|Baseline|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460864|NCT00627523|P2|Participant Flow|Control|This group was the untreated control group and was not administered placebo.
460925|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine
N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460865|NCT00627523|P1|Participant Flow|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460866|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
460867|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460868|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
460869|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460870|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
460871|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460872|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
460873|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460874|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
460875|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460876|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
460877|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460878|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
460879|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460880|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
460881|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460882|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
460883|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460884|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
460885|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460886|NCT00627523|E2|Reported Event|Control|This group was the untreated control group and was not administered placebo.
460887|NCT00627523|E1|Reported Event|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
460888|NCT00627679|B1|Baseline|All Patients|All patients that were enrolled in the study.
460889|NCT00627679|P4|Participant Flow|Treatment D, A, C, B|Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5
461294|NCT00628927|B3|Baseline|Total|Total of all reporting groups
460890|NCT00627679|P3|Participant Flow|Treatment C, D, B, A|Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 5
460891|NCT00627679|P2|Participant Flow|Treatment B, C, A, D|Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5
460892|NCT00627679|P1|Participant Flow|Treatment A, B, D, C|Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5
460893|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
460894|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
460895|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
460896|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
460897|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
460898|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
460899|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
460900|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
460901|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
460902|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
460903|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
460904|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
460905|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
460906|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
460907|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
460908|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
460909|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
460910|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
460911|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
460912|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
460913|NCT00627679|E4|Reported Event|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
460914|NCT00627679|E3|Reported Event|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
460915|NCT00627679|E2|Reported Event|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
460916|NCT00627679|E1|Reported Event|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
460917|NCT00627705|B3|Baseline|Total|Total of all reporting groups
460918|NCT00627705|B2|Baseline|Sugar Pill|"Placebo or sugar pill
Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460919|NCT00627705|B1|Baseline|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine
N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460920|NCT00627705|P2|Participant Flow|Sugar Pill|"Placebo or sugar pill
Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460921|NCT00627705|P1|Participant Flow|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine
N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460922|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill
Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460923|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine
N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
461035|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
460924|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill
Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
461132|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461335|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
460926|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill
Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460927|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine
N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460928|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill
Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460929|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine
N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460930|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill
Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460931|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine
N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460932|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill
Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460933|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine
N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460934|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill
Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460935|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine
N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460936|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill
Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460937|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine
N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460938|NCT00627705|E2|Reported Event|Sugar Pill|"Placebo or sugar pill
Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460939|NCT00627705|E1|Reported Event|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine
N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous)."
460940|NCT00627861|B1|Baseline|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
460941|NCT00627861|P1|Participant Flow|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
460942|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for an additional 2 weeks
460943|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for an additional 2 weeks.
460944|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
460945|NCT00627861|E1|Reported Event|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
460946|NCT00627926|B4|Baseline|Total|Total of all reporting groups
460947|NCT00627926|B3|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460948|NCT00627926|B2|Baseline|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460965|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460949|NCT00627926|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
461133|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
460950|NCT00627926|P3|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460951|NCT00627926|P2|Participant Flow|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460952|NCT00627926|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460953|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460954|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460955|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460956|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460957|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460958|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460959|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460960|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460961|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460962|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460963|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460964|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460966|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460967|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460968|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460969|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460970|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460971|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460972|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460973|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460974|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460975|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460976|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460977|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460978|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460979|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460980|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460981|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460982|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460983|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460984|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460985|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460986|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460987|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460988|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460989|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460990|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460991|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460992|NCT00627926|E3|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460993|NCT00627926|E2|Reported Event|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
460994|NCT00627926|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
460995|NCT00627978|B3|Baseline|Total|Total of all reporting groups
460996|NCT00627978|B2|Baseline|Control|Participants receive no intervention.
460997|NCT00627978|B1|Baseline|Ixabepilone|"Participants are treated with Ixabepilone.
ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
460998|NCT00627978|P2|Participant Flow|Control|No treatment with Ixabepilone
460999|NCT00627978|P1|Participant Flow|Ixabepilone|"Participants are treated with Ixabepilone.
ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
461000|NCT00627978|O2|Outcome|Control|No treatment with Ixabepilone
461001|NCT00627978|O1|Outcome|Ixabepilone|"Participants are treated with Ixabepilone.
ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
461002|NCT00627978|E2|Reported Event|Control|Participants are not treated with Ixabepilone.
461003|NCT00627978|E1|Reported Event|Ixabepilone|"Participants are treated with Ixabepilone.
ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
461004|NCT00628030|B3|Baseline|Total|Total of all reporting groups
461120|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
468997|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
461036|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461037|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461005|NCT00628030|B2|Baseline|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
461006|NCT00628030|B1|Baseline|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
461007|NCT00628030|P2|Participant Flow|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
461008|NCT00628030|P1|Participant Flow|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
461009|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
461010|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
461011|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
461012|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
461013|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
461014|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
461034|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461015|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
461016|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
461017|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
461018|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
461019|NCT00628030|E2|Reported Event|Wellness Group|The placebo control group attended a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, parents received pedometers for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were sent home one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.Followed up for 6 months.
461020|NCT00628030|E1|Reported Event|NOURISH|The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. The interventions differed only in duration. They covered the same concepts which are grounded in Social Cognitive Theory (SCT). Throughout the interventions the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics provided information about implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
461021|NCT00628108|B3|Baseline|Total|Total of all reporting groups
461022|NCT00628108|B2|Baseline|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461023|NCT00628108|B1|Baseline|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461024|NCT00628108|P2|Participant Flow|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461025|NCT00628108|P1|Participant Flow|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461026|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461027|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461028|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461029|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461030|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461031|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461032|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461033|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461038|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461039|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461040|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461041|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461042|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461043|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461044|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461045|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461046|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461047|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461048|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461049|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461050|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461051|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461052|NCT00628108|E2|Reported Event|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461053|NCT00628108|E1|Reported Event|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
461054|NCT00628134|B1|Baseline|Cystic Fibrosis Subjects|"Subjects with cystic fibrosis
isotonic saline aerosol : single inhaled dose, 3ml by nebulizer
calfactant aerosol : single inhaled dose, 3ml by nebulizer"
461055|NCT00628134|P2|Participant Flow|Saline Aerosol Then Surfactant Aerosol|cystic fibrosis patients who inhaled saline aerosol at the first study visit and surfactant aerosol at the second study visit
461056|NCT00628134|P1|Participant Flow|Surfactant Aerosol Then Saline Aerosol|cystic fibrosis patients who inhaled surfactant aerosol at the first study visit and saline aerosol at the second study visit
461057|NCT00628134|O2|Outcome|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
461058|NCT00628134|O1|Outcome|Subjects Inhaling Saline|Subjects with cystic fibrosis
461059|NCT00628134|O2|Outcome|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
461060|NCT00628134|O1|Outcome|Subjects Inhaling Saline|Subjects with cystic fibrosis
461061|NCT00628134|E2|Reported Event|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
461062|NCT00628134|E1|Reported Event|Subjects Inhaling Saline|Subjects with cystic fibrosis
461063|NCT00628147|B3|Baseline|Total|Total of all reporting groups
461064|NCT00628147|B2|Baseline|White Light|Conventional White Light Examination
461065|NCT00628147|B1|Baseline|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
461066|NCT00628147|P2|Participant Flow|White Light|Conventional White Light Examination
461067|NCT00628147|P1|Participant Flow|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
461068|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
461121|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
461122|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
461069|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
461070|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
461071|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
461072|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
461073|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
461074|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
461075|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
461076|NCT00628147|E2|Reported Event|White Light|Conventional White Light Examination
461077|NCT00628147|E1|Reported Event|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
461078|NCT00628212|B5|Baseline|Total|Total of all reporting groups
461079|NCT00628212|B4|Baseline|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
461080|NCT00628212|B3|Baseline|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
461081|NCT00628212|B2|Baseline|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
461082|NCT00628212|B1|Baseline|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
461083|NCT00628212|P4|Participant Flow|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
461084|NCT00628212|P3|Participant Flow|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
461085|NCT00628212|P2|Participant Flow|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
461086|NCT00628212|P1|Participant Flow|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
461087|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
461088|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
461089|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
461090|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
461091|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
461092|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
461093|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
461094|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
461095|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
461096|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
461097|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
461098|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
461099|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
461100|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
461101|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
461102|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
461103|NCT00628212|E4|Reported Event|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
461104|NCT00628212|E3|Reported Event|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
461105|NCT00628212|E2|Reported Event|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
461106|NCT00628212|E1|Reported Event|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
461107|NCT00628251|B4|Baseline|Total|Total of all reporting groups
461108|NCT00628251|B3|Baseline|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461109|NCT00628251|B2|Baseline|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
461110|NCT00628251|B1|Baseline|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
461111|NCT00628251|P3|Participant Flow|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461112|NCT00628251|P2|Participant Flow|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
461113|NCT00628251|P1|Participant Flow|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
461114|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461115|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
461116|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
461117|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461118|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
461119|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
461123|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461124|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
461125|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
461126|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461336|NCT00629239|O2|Outcome|Placebo|Placebo
461135|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461136|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
461137|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
461138|NCT00628251|O4|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461139|NCT00628251|O3|Outcome|Olaparib 200 mg bd + Olaparib 400 mg bd,|Olaparib (AZD2281) 200 or 400 mg oral capsules twice daily
461140|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
461141|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
461142|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461143|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
461144|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
461145|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461146|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
461147|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
461148|NCT00628251|E3|Reported Event|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
461149|NCT00628251|E2|Reported Event|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
461150|NCT00628251|E1|Reported Event|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
461151|NCT00628355|B3|Baseline|Total|Total of all reporting groups
461152|NCT00628355|B2|Baseline|Anesthesia Injection|group received lidocaine injections once a week for 4 weeks
461153|NCT00628355|B1|Baseline|Ischemic Compression|Group received TENS plus Ischemic compression
461154|NCT00628355|P2|Participant Flow|Anesthesia Injection|Group received lidocaine injection
461155|NCT00628355|P1|Participant Flow|TENS Plus Ischemic Compression|Group received TENS plus ischemic compression
461156|NCT00628355|O2|Outcome|Anesthesia Injection|Group received lidocaine injection
461157|NCT00628355|O1|Outcome|TENS Plus Ischemic Compression|Group received TENS plus ischemic compression
461158|NCT00628355|O2|Outcome|Anesthesia Injection|Group received lidocaine injection
461159|NCT00628355|O1|Outcome|Ischemic Compression|Group received ischemic compression
461160|NCT00628355|E2|Reported Event|Anesthesia Injection|group received lidocaine injections once a week for 4 weeks
461161|NCT00628355|E1|Reported Event|Ischemic Compression|Group received Ischemic compression
461162|NCT00628407|B1|Baseline|Sternal Wall Pressure|
461163|NCT00628407|P1|Participant Flow|Sternal Wall Pressure|Subjects that received gentle incremental sternal wall pressure.
461164|NCT00628407|O1|Outcome|Sternal Wall Pressure|
461165|NCT00628407|E1|Reported Event|Sternal Wall Pressure|
461166|NCT00628446|B1|Baseline|Study Group|
461167|NCT00628446|P1|Participant Flow|Study Group|
461168|NCT00628446|O1|Outcome|Group 1|
461169|NCT00628446|O1|Outcome|Study Group|Cross-sectional study group
461170|NCT00628446|E1|Reported Event|Study Group|
461171|NCT00628589|B4|Baseline|Total|Total of all reporting groups
461172|NCT00628589|B3|Baseline|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
461173|NCT00628589|B2|Baseline|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
461174|NCT00628589|B1|Baseline|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
461175|NCT00628589|P3|Participant Flow|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
461176|NCT00628589|P2|Participant Flow|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
461177|NCT00628589|P1|Participant Flow|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
461178|NCT00628589|O3|Outcome|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
461179|NCT00628589|O2|Outcome|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
461180|NCT00628589|O1|Outcome|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
461181|NCT00628589|O3|Outcome|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
461182|NCT00628589|O2|Outcome|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
461183|NCT00628589|O1|Outcome|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
461184|NCT00628589|O3|Outcome|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
461185|NCT00628589|O2|Outcome|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
461259|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461186|NCT00628589|O1|Outcome|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
461187|NCT00628589|E3|Reported Event|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
461188|NCT00628589|E2|Reported Event|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
461189|NCT00628589|E1|Reported Event|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
461190|NCT00628628|B3|Baseline|Total|Total of all reporting groups
461191|NCT00628628|B2|Baseline|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
461192|NCT00628628|B1|Baseline|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
461193|NCT00628628|P2|Participant Flow|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
461194|NCT00628628|P1|Participant Flow|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
461195|NCT00628628|O2|Outcome|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
461196|NCT00628628|O1|Outcome|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
461197|NCT00628628|E2|Reported Event|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
461198|NCT00628628|E1|Reported Event|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
461199|NCT00628758|B3|Baseline|Total|Total of all reporting groups
461200|NCT00628758|B2|Baseline|Conventional BP|Conventional Best Practice for Treatment of asthma
461201|NCT00628758|B1|Baseline|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
461202|NCT00628758|P2|Participant Flow|Conventional BP|Conventional Best Practice for Treatment of asthma
461203|NCT00628758|P1|Participant Flow|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
461204|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
461205|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
461206|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
461207|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
461208|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
461209|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
461210|NCT00628758|O2|Outcome|Conventional Best Practice (BP)|Conventional Best Practice for Treatment of asthma
461211|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microgram (microg), 1 inh bid + as need)
461212|NCT00628758|E2|Reported Event|Conventional BP|Conventional Best Practice for Treatment of asthma
461213|NCT00628758|E1|Reported Event|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
461214|NCT00628862|B4|Baseline|Total|Total of all reporting groups
461215|NCT00628862|B3|Baseline|Placebo|Placebo
461216|NCT00628862|B2|Baseline|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461217|NCT00628862|B1|Baseline|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461218|NCT00628862|P3|Participant Flow|Placebo|Placebo
461219|NCT00628862|P2|Participant Flow|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461220|NCT00628862|P1|Participant Flow|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461221|NCT00628862|O3|Outcome|Placebo|Placebo
461222|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461223|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461224|NCT00628862|O3|Outcome|Placebo|Placebo
461225|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461226|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461227|NCT00628862|O3|Outcome|Placebo|Placebo
461228|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461229|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461230|NCT00628862|O3|Outcome|Placebo|Placebo
461231|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461232|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461233|NCT00628862|O3|Outcome|Placebo|Placebo
461234|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461235|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461236|NCT00628862|O3|Outcome|Placebo|Placebo
461237|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461238|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461239|NCT00628862|O3|Outcome|Placebo|Placebo
461240|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461241|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461242|NCT00628862|O3|Outcome|Placebo|Placebo
461243|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461244|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461245|NCT00628862|O3|Outcome|Placebo|Placebo
461246|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461247|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461248|NCT00628862|O3|Outcome|Placebo|Placebo
461249|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461250|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461251|NCT00628862|O3|Outcome|Placebo|Placebo
461252|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461253|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461254|NCT00628862|O3|Outcome|Placebo|Placebo
461255|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461256|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461257|NCT00628862|O3|Outcome|Placebo|Placebo
461258|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461261|NCT00628862|E2|Reported Event|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
461262|NCT00628862|E1|Reported Event|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
461263|NCT00628901|B3|Baseline|Total|Total of all reporting groups
461264|NCT00628901|B2|Baseline|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461265|NCT00628901|B1|Baseline|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461266|NCT00628901|P2|Participant Flow|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461267|NCT00628901|P1|Participant Flow|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461268|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461269|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461270|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461271|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461272|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461273|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461274|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461275|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461276|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461277|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461278|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461279|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461280|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461281|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461282|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461283|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461284|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461285|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461286|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461287|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461288|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461558|NCT00635219|P2|Participant Flow|Vortioxetine 2.5 mg|encapsulated tablets; orally
461559|NCT00635219|P1|Participant Flow|Placebo|capsules; daily; orally
461289|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461290|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461291|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461292|NCT00628901|E2|Reported Event|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
461293|NCT00628901|E1|Reported Event|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
461295|NCT00628927|B2|Baseline|Normal Control Participants|Normal Control participants recruited from the community
461296|NCT00628927|B1|Baseline|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
461297|NCT00628927|P2|Participant Flow|Normal Control Participants|Normal Control participants recruited from the community
461298|NCT00628927|P1|Participant Flow|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
461299|NCT00628927|O3|Outcome|Normal Controls|Normal controls recruited from the community.
461300|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|"Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for 2 participants who were ineligible but enrolled were removed from analysis 1 participant did not complete the blood draw
1 participant sample was insufficient for analysis"
461301|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week 3 participant samples were insufficient for analysis
461302|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|"Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data from the two ineligible by enrolled participants was removed from the analysis.
Data from 3 other participants was incomplete and therefore removed from the analysis."
461303|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week Data from one participant was excluded from analysis due to lack of completeness
461304|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for the two ineligible but enrolled participants was removed from the analysis.
461305|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week
461306|NCT00628927|E2|Reported Event|Normal Control Participants|Normal Control participants recruited from the community
461307|NCT00628927|E1|Reported Event|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
461308|NCT00629018|B3|Baseline|Total|Total of all reporting groups
461309|NCT00629018|B2|Baseline|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
461310|NCT00629018|B1|Baseline|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
461311|NCT00629018|P2|Participant Flow|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
461312|NCT00629018|P1|Participant Flow|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
461313|NCT00629018|O2|Outcome|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
461314|NCT00629018|O1|Outcome|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
461315|NCT00629018|O2|Outcome|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
461316|NCT00629018|O1|Outcome|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
461317|NCT00629018|E2|Reported Event|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
461318|NCT00629018|E1|Reported Event|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
461319|NCT00629239|B3|Baseline|Total|Total of all reporting groups
461320|NCT00629239|B2|Baseline|Placebo|Placebo
461321|NCT00629239|B1|Baseline|AZD4818|AZD4818 Turbuhaler
461322|NCT00629239|P2|Participant Flow|Placebo|Placebo
461323|NCT00629239|P1|Participant Flow|AZD4818|AZD4818 Turbuhaler
461324|NCT00629239|O2|Outcome|Placebo|Placebo
461325|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
461326|NCT00629239|O2|Outcome|Placebo|Placebo
461327|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
461328|NCT00629239|O2|Outcome|Placebo|Placebo
461329|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
461330|NCT00629239|O2|Outcome|Placebo|Placebo
461331|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
461332|NCT00629239|O2|Outcome|Placebo|Placebo
461333|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
461334|NCT00629239|O2|Outcome|Placebo|Placebo
461344|NCT00629239|O2|Outcome|Placebo|Placebo
461345|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
461346|NCT00629239|O2|Outcome|Placebo|Placebo
461347|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
461348|NCT00629239|O2|Outcome|Placebo|Placebo
461349|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
461350|NCT00629239|O2|Outcome|Placebo|Placebo
461351|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
461352|NCT00629239|E2|Reported Event|Placebo|Placebo
461353|NCT00629239|E1|Reported Event|AZD4818|AZD4818 Turbuhaler
461354|NCT00629265|B3|Baseline|Total|Total of all reporting groups
461355|NCT00629265|B2|Baseline|Sham NMES Group|Sham NMES combined with exercise therapy
461356|NCT00629265|B1|Baseline|Active NMES Group|NMES therapy combined with exercise therapy
461357|NCT00629265|P2|Participant Flow|Sham NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
461358|NCT00629265|P1|Participant Flow|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
461359|NCT00629265|O2|Outcome|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
461360|NCT00629265|O1|Outcome|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
461361|NCT00629265|O2|Outcome|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
461362|NCT00629265|O1|Outcome|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
461363|NCT00629265|E2|Reported Event|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
461364|NCT00629265|E1|Reported Event|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
461365|NCT00629499|B1|Baseline|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
461366|NCT00629499|P1|Participant Flow|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
461367|NCT00629499|O1|Outcome|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
461560|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
461368|NCT00629499|E1|Reported Event|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
461369|NCT00635024|B1|Baseline|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
461370|NCT00635024|P1|Participant Flow|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
461371|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
461372|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
461373|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
461374|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
461375|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
461376|NCT00635024|E1|Reported Event|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
461390|NCT00635089|O1|Outcome|Open-Label Reslizumab: 1 mg/kg|Open-label reslizumab IV infusion at 1 mg/kg monthly
461584|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
461585|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
461377|NCT00635050|B1|Baseline|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.
Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, then paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to chemotherapy will receive an additional year of Avastin at the same dose equivalent starting 6-8 weeks after operation.
Regimen B: Identical to Regimen A except that the dose of Doxil will be 30 mg/m2."
461378|NCT00635050|P1|Participant Flow|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.
Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation.
Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week"
461379|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.
Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, then paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to chemotherapy will receive an additional year of Avastin at the same dose equivalent starting 6-8 weeks after operation.
Regimen B: Identical to Regimen A except that the dose of Doxil will be 30 mg/m2."
461380|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.
Doxil, Paclitaxel, Cyclophosphamide, Avastin:
Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.
Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
461381|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.
Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.
Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
461382|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.
Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.
Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
461416|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461561|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
461562|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
461383|NCT00635050|E1|Reported Event|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.
Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation.
Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week"
461384|NCT00635089|B1|Baseline|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461385|NCT00635089|P1|Participant Flow|Open-Label Reslizumab|Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly
461386|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461387|NCT00635089|O4|Outcome|Open-Label Reslizumab: Overall|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly, continued at 1 to 3 mg/kg monthly
461388|NCT00635089|O3|Outcome|Open-Label Reslizumab: 3 mg/kg|Open-label reslizumab IV infusion at 3 mg/kg monthly
461389|NCT00635089|O2|Outcome|Open-Label Reslizumab: 2 mg/kg|Open-label reslizumab IV infusion at 2 mg/kg monthly
463248|NCT00638365|P2|Participant Flow|KB001, 3 mg/kg|
461391|NCT00635089|O4|Outcome|Changed by Eating Foods That Previously Worsened EoE|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434) by eating foods that previously worsened EoE.
461392|NCT00635089|O3|Outcome|Changed by Increasing Consistency of Food|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434) by increasing the consistency of their food.
461393|NCT00635089|O2|Outcome|Changed Diet From Beginning of Double-blind Study|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434).
461394|NCT00635089|O1|Outcome|Maintained Diet From Beginning of Double-blind Study|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who maintained their diet from the beginning of the double-blind study (NCT00538434).
461395|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461396|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461397|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461398|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461399|NCT00635089|O5|Outcome|Grade 4|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 4.
461400|NCT00635089|O4|Outcome|Grade 3|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 3.
461401|NCT00635089|O3|Outcome|Grade 2|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 2.
461402|NCT00635089|O2|Outcome|Grade 1|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 1.
461403|NCT00635089|O1|Outcome|Grade 0|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 0.
461404|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461405|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461406|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461407|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461408|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461409|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461410|NCT00635089|E1|Reported Event|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
461411|NCT00635102|B3|Baseline|Total|Total of all reporting groups
461412|NCT00635102|B2|Baseline|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461413|NCT00635102|B1|Baseline|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461414|NCT00635102|P2|Participant Flow|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the structured clinical interview (SCID).
461415|NCT00635102|P1|Participant Flow|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet Diagnostic and Statistical manual (DSM) IV criteria for alcohol dependence by structured clinical interview
461550|NCT00635219|B5|Baseline|Duloxetine 60 mg|encapsulated capsules; orally
461551|NCT00635219|B4|Baseline|Vortioxetine 10 mg|encapsulated tablets; orally
461417|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461418|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461419|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461420|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461421|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461575|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
461576|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
461577|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
461422|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461423|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461424|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461425|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461426|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461427|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461428|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461429|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461430|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461431|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461432|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461433|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461434|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461435|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461436|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461437|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461552|NCT00635219|B3|Baseline|Vortioxetine 5 mg|encapsulated tablets; orally
461438|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461439|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461440|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461441|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461442|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461443|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461444|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461445|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461446|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461447|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461448|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461449|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461450|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461451|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461452|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461453|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461454|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461455|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461456|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461457|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461458|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461553|NCT00635219|B2|Baseline|Vortioxetine 2.5 mg|encapsulated tablets; orally
461459|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461460|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461461|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461462|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461463|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461464|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461465|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461466|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461467|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461468|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461469|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461470|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461471|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461472|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461473|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461474|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461475|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461476|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461477|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461478|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461479|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461554|NCT00635219|B1|Baseline|Placebo|capsules; daily; orally
468998|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
461480|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461481|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461482|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461483|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461578|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
461579|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
461580|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
461484|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461485|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461486|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461487|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461488|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461489|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461490|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461491|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461492|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461493|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461494|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461495|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461496|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461497|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461498|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461499|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461500|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461555|NCT00635219|P5|Participant Flow|Duloxetine 60 mg|encapsulated capsules; orally
461501|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461502|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461503|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461504|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
461505|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
461506|NCT00635102|E2|Reported Event|Healthy Subjects|
461507|NCT00635102|E1|Reported Event|Alcoholic Subjects|
461508|NCT00635128|B3|Baseline|Total|Total of all reporting groups
461509|NCT00635128|B2|Baseline|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461510|NCT00635128|B1|Baseline|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461511|NCT00635128|P2|Participant Flow|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461512|NCT00635128|P1|Participant Flow|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461513|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461514|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461515|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461516|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461517|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461518|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461519|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461520|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461521|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461522|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461556|NCT00635219|P4|Participant Flow|Vortioxetine 10 mg|encapsulated tablets; orally
461557|NCT00635219|P3|Participant Flow|Vortioxetine 5 mg|encapsulated tablets; orally
461523|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461524|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461525|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461581|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
461582|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
461583|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
461526|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461527|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461528|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461529|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461530|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461531|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461532|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461533|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461534|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461535|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461536|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461537|NCT00635128|E2|Reported Event|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461538|NCT00635128|E1|Reported Event|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
461539|NCT00635154|B1|Baseline|Anakinra With/Without Dexamethasone|
461540|NCT00635154|P1|Participant Flow|Anakinra With/Without Dexamethasone|
461541|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
461542|NCT00635154|O1|Outcome|Anakinra With Dexamethasone|Patients in this outcome received both Anakinra (100mg daily subcutaneously administered) and dexamethasone (either 20mg/week OR 40mg days 1-4, 9-12, 17-20 every 28 days during odd cycles OR 40 mg days 1-4 every 28 days during even cycles)
461543|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
461544|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
461545|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
461546|NCT00635154|O1|Outcome|Anakinra With Dexamethasone|Patients in this outcome received both Anakinra (100mg daily subcutaneously administered) and dexamethasone (either 20mg/week OR 40mg days 1-4, 9-12, 17-20 every 28 days during odd cycles OR 40 mg days 1-4 every 28 days during even cycles)
461547|NCT00635154|O1|Outcome|Anakinra Without Dexamethasone|Patients in this outcome received only Anakinra (100mg daily subcutaneously administered).
461548|NCT00635154|E1|Reported Event|Anakinra With/Without Dexamethasone|
461549|NCT00635219|B6|Baseline|Total|Total of all reporting groups
461563|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
461564|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
461565|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
461566|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
461567|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
461568|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
461569|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
461570|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
461571|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
461572|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
461573|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
461574|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
461586|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
461587|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
461588|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
461589|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
461590|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
461591|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
461592|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
461593|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
461594|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
461595|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
461596|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
461597|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
461598|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
461599|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
461600|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
461601|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
461602|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
461603|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
461604|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
461605|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
461606|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
461607|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
461608|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
461609|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
461610|NCT00635219|E5|Reported Event|Duloxetine 60 mg|
461611|NCT00635219|E4|Reported Event|Vortioxetine 10 mg|
461612|NCT00635219|E3|Reported Event|Vortioxetine 5 mg|
461613|NCT00635219|E2|Reported Event|Vortioxetine 2.5 mg|
461614|NCT00635219|E1|Reported Event|Placebo|
461615|NCT00635232|B6|Baseline|Total|Total of all reporting groups
461616|NCT00635232|B5|Baseline|PS433540 800mg|PS433540 800mg once daily
461617|NCT00635232|B4|Baseline|PS433540 400mg|PS433540 400mg once daily
461618|NCT00635232|B3|Baseline|PS433540 200mg|PS433540 200mg once daily
461619|NCT00635232|B2|Baseline|Placebo|Blinded Placebo Treatment
461620|NCT00635232|B1|Baseline|Irbesartan 300mg|Irbesartan 300 mg once daily
461621|NCT00635232|P5|Participant Flow|PS433540 800mg|PS433540 800mg once daily
461622|NCT00635232|P4|Participant Flow|PS433540 400mg|PS433540 400mg once daily
461623|NCT00635232|P3|Participant Flow|PS433540 200mg|PS433540 200mg once daily
461624|NCT00635232|P2|Participant Flow|Placebo|Blinded Placebo Treatment
461625|NCT00635232|P1|Participant Flow|Irbesartan 300mg|Irbesartan 300 mg once daily
461626|NCT00635232|O5|Outcome|PS433540 800mg|
461627|NCT00635232|O4|Outcome|PS433540 400mg|
461628|NCT00635232|O3|Outcome|PS433540 200mg|
461629|NCT00635232|O2|Outcome|Placebo|
461630|NCT00635232|O1|Outcome|Irbesartan 300mg|
461631|NCT00635232|O5|Outcome|PS433540 800mg|
461632|NCT00635232|O4|Outcome|PS433540 400mg|
461633|NCT00635232|O3|Outcome|PS433540 200mg|
461634|NCT00635232|O2|Outcome|Placebo|
461635|NCT00635232|O1|Outcome|Irbesartan 300mg|
461636|NCT00635232|O5|Outcome|PS433540 800mg|
461637|NCT00635232|O4|Outcome|PS433540 400mg|
461638|NCT00635232|O3|Outcome|PS433540 200mg|
461639|NCT00635232|O2|Outcome|Placebo|
461640|NCT00635232|O1|Outcome|Irbesartan 300mg|
461641|NCT00635232|E5|Reported Event|PS433540 800mg|PS433540 800mg once daily
461642|NCT00635232|E4|Reported Event|PS433540 400mg|PS433540 400mg once daily
461643|NCT00635232|E3|Reported Event|PS433540 200mg|PS433540 200mg once daily
461644|NCT00635232|E2|Reported Event|Placebo|Blinded Placebo Treatment
461645|NCT00635232|E1|Reported Event|Irbesartan 300mg|Irbesartan 300 mg once daily
461646|NCT00635661|B1|Baseline|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
461647|NCT00635661|P1|Participant Flow|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
461648|NCT00635661|O1|Outcome|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
461649|NCT00635661|E1|Reported Event|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
461650|NCT00635700|B3|Baseline|Total|Total of all reporting groups
461651|NCT00635700|B2|Baseline|Placebo|placebo: placebo
461652|NCT00635700|B1|Baseline|Ziprasidone|ziprasidone: 20-160 mg/d
461653|NCT00635700|P2|Participant Flow|Placebo|placebo: placebo
461654|NCT00635700|P1|Participant Flow|Ziprasidone|ziprasidone: 20-160 mg/d
461655|NCT00635700|O2|Outcome|Placebo|placebo: placebo
461656|NCT00635700|O1|Outcome|Ziprasidone|ziprasidone: 20-160 mg/d
461657|NCT00635700|E2|Reported Event|Placebo|placebo: placebo
461658|NCT00635700|E1|Reported Event|Ziprasidone|ziprasidone: 20-160 mg/d
461659|NCT00635804|B9|Baseline|Total|Total of all reporting groups
461660|NCT00635804|B8|Baseline|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
463249|NCT00638365|P1|Participant Flow|Placebo|
461661|NCT00635804|B7|Baseline|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461662|NCT00635804|B6|Baseline|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461663|NCT00635804|B5|Baseline|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461664|NCT00635804|B4|Baseline|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461665|NCT00635804|B3|Baseline|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461666|NCT00635804|B2|Baseline|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461667|NCT00635804|B1|Baseline|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461668|NCT00635804|P8|Participant Flow|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461669|NCT00635804|P7|Participant Flow|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461670|NCT00635804|P6|Participant Flow|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461671|NCT00635804|P5|Participant Flow|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461672|NCT00635804|P4|Participant Flow|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461673|NCT00635804|P3|Participant Flow|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461674|NCT00635804|P2|Participant Flow|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461675|NCT00635804|P1|Participant Flow|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461676|NCT00635804|O7|Outcome|Placebo|HCV-infected participants in Part II who received dose-matched placebo to MK-03281 orally BID for 7 consecutive days.
461677|NCT00635804|O6|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461778|NCT00635817|P2|Participant Flow|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461678|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panels E+F)|GT1/GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461679|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461680|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461681|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461682|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461683|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461684|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461842|NCT00635882|P2|Participant Flow|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
461685|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461686|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461687|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461688|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461689|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461690|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461691|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461692|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461693|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461694|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461695|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461696|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461697|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461698|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461699|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461700|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461701|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461779|NCT00635817|P1|Participant Flow|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
468999|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
461702|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461703|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461704|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461705|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461706|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461707|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461792|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461793|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461708|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461709|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461710|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461711|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461712|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461713|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461714|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461715|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461716|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461717|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461718|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461719|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461720|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461721|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461722|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461723|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461724|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461725|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461780|NCT00635817|O2|Outcome|Leuprolide Acetate 30 mg|All subjects from both treatment groups who received 30 mg leuprolide acetate, both treatment naive and previously treated, were combined.
461726|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461727|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461728|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461729|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461730|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461731|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461732|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461733|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461734|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461735|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461736|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461737|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461738|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461739|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461740|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461741|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461742|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461743|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461744|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461745|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461746|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461747|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461748|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461749|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461888|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
469000|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
461750|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461751|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461752|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461753|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461754|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461755|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461756|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461757|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461758|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461759|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461760|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461761|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461762|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461763|NCT00635804|E8|Reported Event|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
461764|NCT00635804|E7|Reported Event|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
461765|NCT00635804|E6|Reported Event|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461766|NCT00635804|E5|Reported Event|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
461767|NCT00635804|E4|Reported Event|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
461768|NCT00635804|E3|Reported Event|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
461769|NCT00635804|E2|Reported Event|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
461770|NCT00635804|E1|Reported Event|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
461771|NCT00635817|B5|Baseline|Total|Total of all reporting groups
461772|NCT00635817|B4|Baseline|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461773|NCT00635817|B3|Baseline|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461774|NCT00635817|B2|Baseline|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461775|NCT00635817|B1|Baseline|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461776|NCT00635817|P4|Participant Flow|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461777|NCT00635817|P3|Participant Flow|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461889|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
461781|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg|All subjects from both treatment groups who received 11.25 mg leuprolide acetate, both treatment naive and previously treated, were combined.
461782|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461783|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461784|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461785|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461786|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461787|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461788|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461789|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461790|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461791|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461841|NCT00635882|P3|Participant Flow|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
461794|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461795|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461796|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461797|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461798|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461799|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461800|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461801|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461802|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461803|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461804|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461805|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461806|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461807|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461808|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461809|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461810|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461811|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461812|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461813|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461814|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461815|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461816|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461817|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461818|NCT00635817|E4|Reported Event|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461819|NCT00635817|E3|Reported Event|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461820|NCT00635817|E2|Reported Event|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
461821|NCT00635817|E1|Reported Event|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
461822|NCT00635830|B3|Baseline|Total|Total of all reporting groups
461823|NCT00635830|B2|Baseline|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
461824|NCT00635830|B1|Baseline|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
461825|NCT00635830|P2|Participant Flow|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
461826|NCT00635830|P1|Participant Flow|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
461827|NCT00635830|O2|Outcome|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
461828|NCT00635830|O1|Outcome|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
461829|NCT00635830|E2|Reported Event|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
461830|NCT00635830|E1|Reported Event|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
461831|NCT00635882|B7|Baseline|Total|Total of all reporting groups
461832|NCT00635882|B6|Baseline|Placebo|Placebo MDI BID for 14 days
461833|NCT00635882|B5|Baseline|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
461834|NCT00635882|B4|Baseline|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
461835|NCT00635882|B3|Baseline|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
461836|NCT00635882|B2|Baseline|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
461837|NCT00635882|B1|Baseline|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
461838|NCT00635882|P6|Participant Flow|Placebo|Placebo MDI BID for 14 days
461839|NCT00635882|P5|Participant Flow|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
461840|NCT00635882|P4|Participant Flow|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
461843|NCT00635882|P1|Participant Flow|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
461844|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
461845|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
461846|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
461847|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
461848|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
461849|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
461850|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
461851|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
461852|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
461853|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
461854|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
461855|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
461856|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
461857|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
461858|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
461859|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
461860|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
461861|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
461862|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
461863|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
461864|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
461865|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
461866|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
461867|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
461868|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
461869|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
461870|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
461871|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
461872|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
461873|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
461874|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
461875|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
461876|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
461877|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
461878|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
461879|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
461880|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
461881|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
461882|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
461883|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
461884|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
461885|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
461886|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
461887|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
461890|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
461891|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
461892|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
461893|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
461894|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
461895|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
461896|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
461897|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
461898|NCT00635882|E6|Reported Event|PLACEBO|
461899|NCT00635882|E5|Reported Event|MF MDI 200 MCG BID|
461900|NCT00635882|E4|Reported Event|MF DPI 200 MCG BID|
461901|NCT00635882|E3|Reported Event|MF/F MDI 400/10 MCG BID|
461902|NCT00635882|E2|Reported Event|MF/F MDI 200/10 MCG BID|
461903|NCT00635882|E1|Reported Event|MF/F MDI 100/10 MCG BID|
461904|NCT00636077|B1|Baseline|All Study Participants|
461905|NCT00636077|P4|Participant Flow|Optiflux F200NR First|Patients in this Arm will receive 3 consecutive treatments with the F200NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
462027|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
462028|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
461906|NCT00636077|P3|Participant Flow|Optiflux F160NR First|Patients in this Arm will receive 3 consecutive treatments with the F160NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
461907|NCT00636077|P2|Participant Flow|HD-C4 Small First|Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Small dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
461908|NCT00636077|P1|Participant Flow|HD-C4 Big First|Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Big dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
461909|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
461910|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
461911|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
461912|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
461913|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
461914|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
461915|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
461916|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
461917|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
461918|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
461919|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
461920|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
461921|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
461922|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
461923|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
461924|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
461925|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
461926|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
461927|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
461928|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
461929|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
461930|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
461931|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
461932|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
461933|NCT00636077|E4|Reported Event|F200NR|3 consecutive treatments with the F200NR dialyzer.
461934|NCT00636077|E3|Reported Event|F160NR|3 consecutive treatments with the F160NR dialyzer.
461935|NCT00636077|E2|Reported Event|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
461936|NCT00636077|E1|Reported Event|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
461937|NCT00636155|B1|Baseline|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
461938|NCT00636155|P1|Participant Flow|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
461939|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
461940|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
461941|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
461942|NCT00636155|E1|Reported Event|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
461943|NCT00636168|B3|Baseline|Total|Total of all reporting groups
461967|NCT00636194|B2|Baseline|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
461968|NCT00636194|B1|Baseline|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
461944|NCT00636168|B2|Baseline|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461945|NCT00636168|B1|Baseline|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461980|NCT00636207|B3|Baseline|Part III|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
462029|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
462030|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
461946|NCT00636168|P2|Participant Flow|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461947|NCT00636168|P1|Participant Flow|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461948|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461949|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461950|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461951|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461952|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461953|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461954|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461969|NCT00636194|P2|Participant Flow|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
469001|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
461955|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461956|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461957|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461958|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461959|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461960|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461961|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461962|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461963|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461964|NCT00636168|E2|Reported Event|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461965|NCT00636168|E1|Reported Event|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
461966|NCT00636194|B3|Baseline|Total|Total of all reporting groups
469002|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
461970|NCT00636194|P1|Participant Flow|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
461971|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
461972|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
461973|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
461974|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
461975|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
461976|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
461977|NCT00636194|E2|Reported Event|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
461978|NCT00636194|E1|Reported Event|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
461979|NCT00636207|B4|Baseline|Total|Total of all reporting groups
461981|NCT00636207|B2|Baseline|Part II|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) or Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
461982|NCT00636207|B1|Baseline|Part I|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
461983|NCT00636207|P7|Participant Flow|Part III - Placebo|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
461984|NCT00636207|P6|Participant Flow|Part III - Montelukast and Placebo|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
461985|NCT00636207|P5|Participant Flow|Part III - Montelukast|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
461986|NCT00636207|P4|Participant Flow|Part II - Placebo|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive QD doses of inhaled Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
461987|NCT00636207|P3|Participant Flow|Part II - Montelukast|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
461988|NCT00636207|P2|Participant Flow|Part I - Montelukast and Placebo|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
461989|NCT00636207|P1|Participant Flow|Part I - Montelukast|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg). Each dose was separated by at least a 3-day washout period.
461990|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
461991|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
461992|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
461993|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
461994|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
461995|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
461996|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
461997|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
461998|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
461999|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
462000|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
462001|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
462002|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
462003|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
462004|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
462005|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
462006|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
462007|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
462008|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
462009|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
462010|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
462011|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
462012|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
462013|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
462014|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
462015|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
462016|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
462017|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
462018|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
462019|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
462020|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
462021|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
462022|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
462023|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
462024|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
462025|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
462026|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
462031|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
462032|NCT00636207|O6|Outcome|Placebo|Participants receiving Placebo inhalation powder
462033|NCT00636207|O5|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
462034|NCT00636207|O4|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
462035|NCT00636207|O3|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
462036|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
462037|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
462038|NCT00636207|O6|Outcome|Placebo|Participants receiving Placebo inhalation powder
462039|NCT00636207|O5|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
462040|NCT00636207|O4|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
462041|NCT00636207|O3|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
462042|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
462043|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
462044|NCT00636207|E6|Reported Event|Placebo|Participants receiving Placebo inhalation powder
462045|NCT00636207|E5|Reported Event|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
462046|NCT00636207|E4|Reported Event|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
462047|NCT00636207|E3|Reported Event|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
462048|NCT00636207|E2|Reported Event|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
462049|NCT00636207|E1|Reported Event|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
462050|NCT00636220|B1|Baseline|Confirmed HIV Infection|participants with known (clinically or serologically) confirmed HIV infection.
462051|NCT00636220|P1|Participant Flow|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
462052|NCT00636220|O1|Outcome|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
462053|NCT00636220|E1|Reported Event|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
462054|NCT00636363|B4|Baseline|Total|Total of all reporting groups
462055|NCT00636363|B3|Baseline|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
462056|NCT00636363|B2|Baseline|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462057|NCT00636363|B1|Baseline|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462058|NCT00636363|P3|Participant Flow|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
462059|NCT00636363|P2|Participant Flow|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462060|NCT00636363|P1|Participant Flow|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462061|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
462062|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462063|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462064|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
462065|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462066|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462067|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
462068|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462069|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462070|NCT00636363|E3|Reported Event|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
462071|NCT00636363|E2|Reported Event|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462072|NCT00636363|E1|Reported Event|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
462073|NCT00636389|B1|Baseline|All Study Participants|
462074|NCT00636389|P2|Participant Flow|210H First (Period 1), Then HD-C4 (Period 2)|Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
462075|NCT00636389|P1|Participant Flow|HD-C4 First (Period 1), Then 210H (Period 2)|Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
462076|NCT00636389|O2|Outcome|210H|
462077|NCT00636389|O1|Outcome|HD-C4|
462078|NCT00636389|O2|Outcome|210H|
462079|NCT00636389|O1|Outcome|HD-C4|
462080|NCT00636389|O2|Outcome|210H|
462081|NCT00636389|O1|Outcome|HD-C4|
462149|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
463250|NCT00638365|O3|Outcome|KB001, 10 mg/kg|
462082|NCT00636389|E2|Reported Event|210H First (Period 1), Then HD-C4 (Period 2)|Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
462083|NCT00636389|E1|Reported Event|HD-C4 First (Period 1), Then 210H (Period 2)|Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
462084|NCT00636441|B8|Baseline|Total|Total of all reporting groups
462085|NCT00636441|B7|Baseline|Screen Failure|
462086|NCT00636441|B6|Baseline|Non-guided TC|"Non-genomics guided treatment; randomized to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462087|NCT00636441|B5|Baseline|Non-guided AC|"Non-genomics guided treatment; randomized to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462088|NCT00636441|B4|Baseline|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462089|NCT00636441|B3|Baseline|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462090|NCT00636441|B2|Baseline|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462091|NCT00636441|B1|Baseline|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462092|NCT00636441|P7|Participant Flow|Screen Failure|
462093|NCT00636441|P6|Participant Flow|Non-guided TC|"Non-genomics guided treatment; randomized to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462094|NCT00636441|P5|Participant Flow|Non-guided AC|"Non-genomics guided treatment; randomized to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462095|NCT00636441|P4|Participant Flow|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462096|NCT00636441|P3|Participant Flow|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462097|NCT00636441|P2|Participant Flow|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462098|NCT00636441|P1|Participant Flow|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462099|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
462100|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
462101|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
462102|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
462103|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
462104|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
462105|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
462106|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
462107|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
462108|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
462109|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
462110|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
462111|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
462112|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
462113|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
462114|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
462115|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
462116|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
462117|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
462118|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
462119|NCT00636441|E7|Reported Event|Screen Failures|Screen failures constitute patients who were registered to the study but were not assigned treatment for various reasons.
462120|NCT00636441|E6|Reported Event|Non-guided TC|"Non-genomics guided treatment; randomized to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462121|NCT00636441|E5|Reported Event|Non-guided AC|"Non-genomics guided treatment; randomized to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462122|NCT00636441|E4|Reported Event|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462123|NCT00636441|E3|Reported Event|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462150|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
463251|NCT00638365|O2|Outcome|KB001, 3 mg/kg|
462124|NCT00636441|E2|Reported Event|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC
TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462125|NCT00636441|E1|Reported Event|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC
AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
462126|NCT00636610|B3|Baseline|Total|Total of all reporting groups
462127|NCT00636610|B2|Baseline|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
462128|NCT00636610|B1|Baseline|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
462129|NCT00636610|P2|Participant Flow|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
462130|NCT00636610|P1|Participant Flow|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
462131|NCT00636610|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
462132|NCT00636610|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
462133|NCT00636610|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
462134|NCT00636610|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
462135|NCT00636610|E4|Reported Event|Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab|GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
462136|NCT00636610|E3|Reported Event|Placebo With FOLFIRI+Bevacizumab|Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
462137|NCT00636610|E2|Reported Event|Vismodegib (GDC-0449) With FOLFOX+Bevacizumab|GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
462364|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462138|NCT00636610|E1|Reported Event|Placebo With FOLFOX+Bevacizumab|Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
462139|NCT00636636|B3|Baseline|Total|Total of all reporting groups
462140|NCT00636636|B2|Baseline|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
462141|NCT00636636|B1|Baseline|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
462142|NCT00636636|P2|Participant Flow|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
462143|NCT00636636|P1|Participant Flow|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
462144|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
462145|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
462146|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
462147|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
462148|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
463252|NCT00638365|O1|Outcome|Placebo|
462151|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
462152|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
462153|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
462154|NCT00636636|E2|Reported Event|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
462155|NCT00636636|E1|Reported Event|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
462156|NCT00636649|B3|Baseline|Total|Total of all reporting groups
462157|NCT00636649|B2|Baseline|Placebo|
462158|NCT00636649|B1|Baseline|Escitalopram|
462159|NCT00636649|P2|Participant Flow|Placebo|Dosing of matching placebo was identical.
462160|NCT00636649|P1|Participant Flow|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462161|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
462162|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462163|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
462164|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462165|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
462166|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462167|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
462168|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462169|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
462170|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462171|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
462172|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462173|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
462174|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462175|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462176|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
462177|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462178|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
462179|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462180|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
462181|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
462182|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
462183|NCT00636649|O2|Outcome|Placebo|
462184|NCT00636649|O1|Outcome|Escitalopram|
462185|NCT00636649|E2|Reported Event|Placebo|
462186|NCT00636649|E1|Reported Event|Escitalopram|
462187|NCT00636701|B3|Baseline|Total|Total of all reporting groups
462188|NCT00636701|B2|Baseline|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)
Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
462189|NCT00636701|B1|Baseline|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)
Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
462190|NCT00636701|P2|Participant Flow|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)
Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
462191|NCT00636701|P1|Participant Flow|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)
Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
462413|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462192|NCT00636701|O2|Outcome|Number of Participants Who Received Unprimed rTMS|Number of participants who received 10 min. of sham rTMS Repetitive Transcranial Magnetic Stimulation. Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
462193|NCT00636701|O1|Outcome|Number of Participants Who Received Primed rTMS|Number of participants who received 10 min. of 6-Hz rTMS Repetitive Transcranial Magnetic Stimulation at 90% RMT (3,600 pulses). Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
462194|NCT00636701|E2|Reported Event|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)
Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
462195|NCT00636701|E1|Reported Event|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)
Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
462196|NCT00636792|B1|Baseline|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
462197|NCT00636792|P1|Participant Flow|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
462198|NCT00636792|O1|Outcome|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
462199|NCT00636792|O1|Outcome|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
462200|NCT00636792|E1|Reported Event|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
462201|NCT00636805|B1|Baseline|Patient Receives IV Aloxi|"Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
462202|NCT00636805|P1|Participant Flow|Patient Receives IV Aloxi|"Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
462203|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
462204|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
462205|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
462206|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
462207|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
462208|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
462209|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
462210|NCT00636805|E1|Reported Event|Patient Receives IV Aloxi|"Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
462211|NCT00636818|B1|Baseline|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462212|NCT00636818|P1|Participant Flow|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462213|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462231|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462214|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462215|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462216|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462217|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462238|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462218|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462219|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462220|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462221|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462222|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462223|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462224|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462225|NCT00636818|E1|Reported Event|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
462226|NCT00636961|B3|Baseline|Total|Total of all reporting groups
462227|NCT00636961|B2|Baseline|Sequence 2 : Placebo Followed by Indacaterol 300μg|In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
462228|NCT00636961|B1|Baseline|Sequence 1: Indacaterol 300μg Followed by Placebo|In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
462229|NCT00636961|P2|Participant Flow|Sequence 2 : Placebo Followed by Indacaterol 300μg|In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
462230|NCT00636961|P1|Participant Flow|Sequence 1: Indacaterol 300μg Followed by Placebo|In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
469003|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
462232|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462233|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462234|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462235|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462236|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462237|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462239|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462240|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462241|NCT00636961|E2|Reported Event|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462242|NCT00636961|E1|Reported Event|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
462243|NCT00636987|B1|Baseline|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
462244|NCT00636987|P1|Participant Flow|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
462245|NCT00636987|O3|Outcome|Biocor Mitral Valve|
462246|NCT00636987|O2|Outcome|Biocor Supra Valve|
462247|NCT00636987|O1|Outcome|Biocor Valve|Biocor valves: Replacement for a diseased, damaged, malformed aortic heart valve
462248|NCT00636987|O1|Outcome|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
462249|NCT00636987|O1|Outcome|Implanted With Biocor, Biocor Supra, Biocor Mitral Valves|Biocor (aortic), Biocor Supra (aortic) and Biocor Mitral valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
462250|NCT00636987|E1|Reported Event|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
462251|NCT00637000|B3|Baseline|Total|Total of all reporting groups
462252|NCT00637000|B2|Baseline|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462253|NCT00637000|B1|Baseline|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462254|NCT00637000|P2|Participant Flow|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462255|NCT00637000|P1|Participant Flow|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462256|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462257|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462258|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462259|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462362|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462260|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462261|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462262|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462263|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462264|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462265|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462266|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462267|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462268|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462269|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462270|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462271|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462272|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462273|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462274|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462275|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462276|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462277|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462278|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462279|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
463438|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for disperse blue and the reference allergen
462280|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462281|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462282|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462283|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462284|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462285|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462286|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462287|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462288|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462289|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462290|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462291|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462292|NCT00637000|E2|Reported Event|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462293|NCT00637000|E1|Reported Event|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
462294|NCT00637156|B3|Baseline|Total|Total of all reporting groups
462295|NCT00637156|B2|Baseline|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462296|NCT00637156|B1|Baseline|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462297|NCT00637156|P2|Participant Flow|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462298|NCT00637156|P1|Participant Flow|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462299|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462300|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462301|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462363|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462302|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462303|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462304|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462305|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462306|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462307|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462424|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462308|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462309|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462310|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462311|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462312|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462313|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462314|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462315|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462316|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462317|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462318|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462319|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462320|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462321|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462322|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462323|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462324|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462325|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462326|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462327|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
463636|NCT00641563|O1|Outcome|Dex/Remi|Sedation with dexmedetomidine and remifentanil
462328|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462329|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462330|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462331|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462332|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462333|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462334|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462335|NCT00637156|E2|Reported Event|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
462336|NCT00637156|E1|Reported Event|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
462337|NCT00637195|B3|Baseline|Total|Total of all reporting groups
462338|NCT00637195|B2|Baseline|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462339|NCT00637195|B1|Baseline|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462340|NCT00637195|P2|Participant Flow|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462341|NCT00637195|P1|Participant Flow|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462342|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462343|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462344|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462345|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462346|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462347|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462348|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462349|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462350|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462351|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462352|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462353|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462354|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462355|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462356|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462357|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462358|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462359|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462360|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462361|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
464263|NCT00642993|P1|Participant Flow|SCH 497079|SCH 497079, administered orally, once daily
462365|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462366|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462367|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462368|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462369|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462370|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462371|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462372|NCT00637195|E2|Reported Event|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
462425|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462373|NCT00637195|E1|Reported Event|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
462374|NCT00637247|B3|Baseline|Total|Total of all reporting groups
462375|NCT00637247|B2|Baseline|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
462376|NCT00637247|B1|Baseline|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
462377|NCT00637247|P2|Participant Flow|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
462378|NCT00637247|P1|Participant Flow|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
462379|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
462380|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
462381|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
462382|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
462383|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
462384|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
462385|NCT00637247|E2|Reported Event|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
462386|NCT00637247|E1|Reported Event|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
462387|NCT00637273|B4|Baseline|Total|Total of all reporting groups
462388|NCT00637273|B3|Baseline|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462389|NCT00637273|B2|Baseline|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462390|NCT00637273|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462391|NCT00637273|P3|Participant Flow|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462392|NCT00637273|P2|Participant Flow|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462393|NCT00637273|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462394|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462395|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462396|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462397|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462398|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462399|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462400|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462401|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462402|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462403|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462404|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462405|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462406|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462407|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462408|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462409|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462410|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462411|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462412|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
464264|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
462414|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462415|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462416|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462417|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462418|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462419|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462420|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462421|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462422|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462423|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462426|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462427|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462428|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462429|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462430|NCT00637273|E3|Reported Event|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462431|NCT00637273|E2|Reported Event|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
462432|NCT00637273|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
462433|NCT00637299|B3|Baseline|Total|Total of all reporting groups
462434|NCT00637299|B2|Baseline|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
462435|NCT00637299|B1|Baseline|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
462436|NCT00637299|P2|Participant Flow|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
462437|NCT00637299|P1|Participant Flow|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
462438|NCT00637299|O2|Outcome|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
462439|NCT00637299|O1|Outcome|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
462440|NCT00637299|O2|Outcome|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
462441|NCT00637299|O1|Outcome|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
462442|NCT00637299|E2|Reported Event|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
462443|NCT00637299|E1|Reported Event|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
462444|NCT00637312|B3|Baseline|Total|Total of all reporting groups
462445|NCT00637312|B2|Baseline|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
462446|NCT00637312|B1|Baseline|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
462447|NCT00637312|P2|Participant Flow|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
462448|NCT00637312|P1|Participant Flow|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
462449|NCT00637312|O2|Outcome|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
462450|NCT00637312|O1|Outcome|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
462451|NCT00637312|E2|Reported Event|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
462452|NCT00637312|E1|Reported Event|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
462453|NCT00637377|B5|Baseline|Total|Total of all reporting groups
462454|NCT00637377|B4|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462455|NCT00637377|B3|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462456|NCT00637377|B2|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462514|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
469004|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
462457|NCT00637377|B1|Baseline|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462458|NCT00637377|P4|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462459|NCT00637377|P3|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462460|NCT00637377|P2|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462461|NCT00637377|P1|Participant Flow|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
463253|NCT00638365|E3|Reported Event|KB001, 10 mg/kg|
463254|NCT00638365|E2|Reported Event|KB001, 3 mg/kg|
462462|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462463|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462464|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462465|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462466|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462467|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462468|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462469|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462470|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462471|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462472|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462473|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462474|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462475|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462476|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462477|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462515|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
469005|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
462478|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462479|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462480|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462481|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462524|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
463255|NCT00638365|E1|Reported Event|Placebo|
464600|NCT00646958|O3|Outcome|Linezolid BID|600 mg by mouth (PO) BID
462482|NCT00637377|E4|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462483|NCT00637377|E3|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462484|NCT00637377|E2|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462485|NCT00637377|E1|Reported Event|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
462486|NCT00637416|B3|Baseline|Total|Total of all reporting groups
462487|NCT00637416|B2|Baseline|Placebo and Dietary Control|"Dietary control and placebo
Placebo: placebo taken by mouth daily for 3 months"
462488|NCT00637416|B1|Baseline|Lansoprazole and Dietary Control|"Lansoprazole and dietary control
Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
462489|NCT00637416|P2|Participant Flow|Placebo and Dietary Control|"Dietary control and placebo
Placebo: placebo taken by mouth daily for 3 months"
462490|NCT00637416|P1|Participant Flow|Lansoprazole and Dietary Control|"Lansoprazole and dietary control
Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
462491|NCT00637416|O2|Outcome|Placebo and Dietary Control|"Dietary control and placebo
Placebo: placebo taken by mouth daily for 3 months"
462492|NCT00637416|O1|Outcome|Lansoprazole and Dietary Control|"Lansoprazole and dietary control
Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
462493|NCT00637416|E2|Reported Event|Placebo and Dietary Control|"Dietary control and placebo
Placebo: placebo taken by mouth daily for 3 months"
462494|NCT00637416|E1|Reported Event|Lansoprazole and Dietary Control|"Lansoprazole and dietary control
Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
462495|NCT00637494|B3|Baseline|Total|Total of all reporting groups
462496|NCT00637494|B2|Baseline|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
462497|NCT00637494|B1|Baseline|Mifepristone Followed by an Antidepressant|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
462498|NCT00637494|P2|Participant Flow|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
462499|NCT00637494|P1|Participant Flow|Mifepristone 1200 mg/Day|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
462500|NCT00637494|O2|Outcome|Placebo|"Placebo followed by an antidepressant
placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days"
462501|NCT00637494|O1|Outcome|Active|"Mifepristone followed by an antidepressant
mifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days"
462502|NCT00637494|O2|Outcome|Placebo|"Placebo followed by an antidepressant
placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days"
462503|NCT00637494|O1|Outcome|Active|"Mifepristone followed by an antidepressant
mifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days"
462504|NCT00637494|E2|Reported Event|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
462505|NCT00637494|E1|Reported Event|Mifepristone 1200 mg/Day|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
462506|NCT00637572|B3|Baseline|Total|Total of all reporting groups
462507|NCT00637572|B2|Baseline|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per as single-dose for 12 weeks
462508|NCT00637572|B1|Baseline|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per as single-dose for 12 weeks
462509|NCT00637572|P2|Participant Flow|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
462510|NCT00637572|P1|Participant Flow|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
462511|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
462512|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
462513|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
464265|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
462516|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
462517|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
462518|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
462519|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
462520|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
462521|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
462522|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
462523|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
462525|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
462526|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
462527|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
462528|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
462529|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
462530|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
462531|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
462532|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
462533|NCT00637572|E2|Reported Event|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single dose for 12 weeks
462534|NCT00637572|E1|Reported Event|Megestrol Acetate Oral Suspension NanoCrystal Dispersion|Subjects were treated with 575 mg per day as single dose for 12 weeks
462535|NCT00637728|B3|Baseline|Total|Total of all reporting groups
462536|NCT00637728|B2|Baseline|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462537|NCT00637728|B1|Baseline|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462538|NCT00637728|P3|Participant Flow|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase
462539|NCT00637728|P2|Participant Flow|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462540|NCT00637728|P1|Participant Flow|DB MA-CS 550 mg/Day|Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase
462541|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462542|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462543|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462544|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462545|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462546|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462547|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462548|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462549|NCT00637728|E3|Reported Event|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase
462550|NCT00637728|E2|Reported Event|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462551|NCT00637728|E1|Reported Event|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462552|NCT00637780|B1|Baseline|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462553|NCT00637780|P1|Participant Flow|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462554|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462585|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
464266|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
462555|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462556|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462557|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462558|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
464147|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
462559|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462560|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462561|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462562|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462563|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462564|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462565|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462566|NCT00637780|E1|Reported Event|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
462567|NCT00637806|B4|Baseline|Total|Total of all reporting groups
462568|NCT00637806|B3|Baseline|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462569|NCT00637806|B2|Baseline|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
462570|NCT00637806|B1|Baseline|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462571|NCT00637806|P4|Participant Flow|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase
462572|NCT00637806|P3|Participant Flow|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462573|NCT00637806|P2|Participant Flow|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
462574|NCT00637806|P1|Participant Flow|DB MA-CS 550 mg/Day|Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase
462575|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462576|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
462577|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462578|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462579|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
462580|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462581|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462582|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
462583|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462584|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
464267|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
462586|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462587|NCT00637806|E4|Reported Event|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase
462588|NCT00637806|E3|Reported Event|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
462589|NCT00637806|E2|Reported Event|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
462590|NCT00637806|E1|Reported Event|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
462591|NCT00637923|B3|Baseline|Total|Total of all reporting groups
462592|NCT00637923|B2|Baseline|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462593|NCT00637923|B1|Baseline|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462594|NCT00637923|P2|Participant Flow|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462595|NCT00637923|P1|Participant Flow|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462596|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462597|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462598|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462599|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462600|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462601|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462602|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462603|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462604|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462605|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462606|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462607|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462608|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462609|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462610|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462611|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462612|NCT00637923|E2|Reported Event|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462613|NCT00637923|E1|Reported Event|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
462614|NCT00638014|B3|Baseline|Total|Total of all reporting groups
462615|NCT00638014|B2|Baseline|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
462616|NCT00638014|B1|Baseline|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
462823|NCT00638222|O2|Outcome|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
462617|NCT00638014|P2|Participant Flow|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
462618|NCT00638014|P1|Participant Flow|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
462619|NCT00638014|O2|Outcome|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
462620|NCT00638014|O1|Outcome|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
462621|NCT00638014|O2|Outcome|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
462622|NCT00638014|O1|Outcome|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
462623|NCT00638014|E2|Reported Event|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
462624|NCT00638014|E1|Reported Event|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
462625|NCT00638027|B3|Baseline|Total|Total of all reporting groups
462626|NCT00638027|B2|Baseline|Placebo|Placebo arm
462627|NCT00638027|B1|Baseline|Memantine|Memantine 10 mg bid
462628|NCT00638027|P2|Participant Flow|Placebo|Placebo arm
462629|NCT00638027|P1|Participant Flow|Memantine|Memantine 10 mg bid
462630|NCT00638027|O2|Outcome|Placebo|Placebo arm
462631|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
462632|NCT00638027|O2|Outcome|Placebo|Placebo arm
462633|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
462634|NCT00638027|O2|Outcome|Placebo|Placebo arm
462635|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
462636|NCT00638027|E2|Reported Event|Placebo|Placebo arm
462637|NCT00638027|E1|Reported Event|Memantine|Memantine 10 mg bid
462638|NCT00638157|B3|Baseline|Total|Total of all reporting groups
462639|NCT00638157|B2|Baseline|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
462640|NCT00638157|B1|Baseline|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
462641|NCT00638157|P2|Participant Flow|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
462642|NCT00638157|P1|Participant Flow|Daptomycin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
462643|NCT00638157|O2|Outcome|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
462644|NCT00638157|O1|Outcome|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
462645|NCT00638157|O2|Outcome|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
462646|NCT00638157|O1|Outcome|Daptomycin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
462647|NCT00638157|E2|Reported Event|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
462648|NCT00638157|E1|Reported Event|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
462649|NCT00626743|B3|Baseline|Total|Total of all reporting groups
462650|NCT00626743|B2|Baseline|Asan Medical Center|
462651|NCT00626743|B1|Baseline|INJE University Pusan Paik Hospital|
462652|NCT00626743|P2|Participant Flow|Placebo|"Tablet which has the same appearance and taste but doesn’t contain active ingredient
SK3530 100mg, Placebo, Amlodipine"
462653|NCT00626743|P1|Participant Flow|SK3530|"Active Drug
SK3530 100mg, Placebo, Amlodipine"
462654|NCT00626743|O2|Outcome|Amlodipine + Placebo|
462655|NCT00626743|O1|Outcome|Amlodipine + SK3530|
462656|NCT00626743|O2|Outcome|Amlodipine + Placebo|
462657|NCT00626743|O1|Outcome|Amlodipine + SK3530|
462658|NCT00626743|E2|Reported Event|Amlodipine + Placebo|
462659|NCT00626743|E1|Reported Event|Amlodipine + SK3530|
462660|NCT00626782|B3|Baseline|Total|Total of all reporting groups
462661|NCT00626782|B2|Baseline|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.
Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
462662|NCT00626782|B1|Baseline|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.
Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
462855|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462663|NCT00626782|P2|Participant Flow|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.
Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
462664|NCT00626782|P1|Participant Flow|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.
Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
462665|NCT00626782|O2|Outcome|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.
Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
462666|NCT00626782|O1|Outcome|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.
Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
462667|NCT00626782|E2|Reported Event|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.
Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
462668|NCT00626782|E1|Reported Event|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.
Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
462669|NCT00626808|B5|Baseline|Total|Total of all reporting groups
462670|NCT00626808|B4|Baseline|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462671|NCT00626808|B3|Baseline|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462672|NCT00626808|B2|Baseline|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462673|NCT00626808|B1|Baseline|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462674|NCT00626808|P4|Participant Flow|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462675|NCT00626808|P3|Participant Flow|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462676|NCT00626808|P2|Participant Flow|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462677|NCT00626808|P1|Participant Flow|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462678|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462679|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462680|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462681|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462682|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462683|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462684|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462685|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462686|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462687|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462688|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462689|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462690|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462691|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462692|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462693|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462694|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462695|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462696|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462697|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462698|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462891|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462699|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462700|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462701|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462702|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462703|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462704|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462705|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462706|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462707|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462708|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462709|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462710|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462711|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462712|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462713|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462714|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462715|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462716|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462717|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462718|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462719|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462720|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462721|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462722|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462723|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462724|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462725|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462726|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462727|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462728|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462729|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462730|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462731|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462732|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462733|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462734|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462735|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462736|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
462737|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462738|NCT00626808|E4|Reported Event|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
462739|NCT00626808|E3|Reported Event|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
462740|NCT00626808|E2|Reported Event|Children 24-59 Months With Asthma|
462741|NCT00626808|E1|Reported Event|Participants Less Than 24 Months of Age|Participants less than 24 months of age
462742|NCT00626821|B1|Baseline|SenSura|Test of SenSura for 6-8 weeks
462743|NCT00626821|P1|Participant Flow|SenSura|Test of SenSura for 6-8 weeks
462744|NCT00626821|O1|Outcome|SenSura|Participants tested SenSura for 6-8 weeks. Baseline data were informations about pre-study product.
462745|NCT00626821|E1|Reported Event|SenSura|Test of SenSura for 6-8 weeks
462746|NCT00626925|B3|Baseline|Total|Total of all reporting groups
462747|NCT00626925|B2|Baseline|Total Placebo Group|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462748|NCT00626925|B1|Baseline|Total Topiramate Group|"topiramate (up to 200 mg orally)
topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462749|NCT00626925|P2|Participant Flow|Placebo|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462750|NCT00626925|P1|Participant Flow|Active Med|"topiramate (up to 200 mg orally)
topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462751|NCT00626925|O2|Outcome|Placebo Group|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462752|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)
Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462753|NCT00626925|O2|Outcome|Placebo|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462754|NCT00626925|O1|Outcome|Active Med|"topiramate (up to 200 mg orally)
topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462755|NCT00626925|O2|Outcome|Placebo|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462756|NCT00626925|O1|Outcome|Active Med|"topiramate (up to 200 mg orally)
topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462757|NCT00626925|O6|Outcome|Placebo AA Genotype|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462758|NCT00626925|O5|Outcome|Topiramate AA Genotype|"topiramate (up to 200 mg orally)
topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462759|NCT00626925|O4|Outcome|Placebo AC Genotype|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
469006|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
462760|NCT00626925|O3|Outcome|Topiramate AC Genotype|"topiramate (up to 200 mg orally)
topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462761|NCT00626925|O2|Outcome|Placebo CC Genotype|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462762|NCT00626925|O1|Outcome|Topiramate CC Genotype|"topiramate (up to 200 mg orally)
topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462763|NCT00626925|O6|Outcome|Placebo AA Genotype|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462764|NCT00626925|O5|Outcome|Topiramate AA Genotype|"topiramate (up to 200 mg orally)
topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
467415|NCT00654498|E2|Reported Event|Placebo|
462765|NCT00626925|O4|Outcome|Placebo AC Genotype|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462766|NCT00626925|O3|Outcome|Topiramate AC Genotype|"topiramate (up to 200 mg orally)
topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462767|NCT00626925|O2|Outcome|Placebo CC Genotype|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462768|NCT00626925|O1|Outcome|Topiramate CC Genotype|"topiramate (up to 200 mg orally)
topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462769|NCT00626925|O2|Outcome|Placebo Group|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462770|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)
Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462771|NCT00626925|O2|Outcome|Placebo Group|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462772|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)
Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462773|NCT00626925|E2|Reported Event|Placebo Group|"placebo
placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462774|NCT00626925|E1|Reported Event|Topiramate Group|"topiramate (up to 200 mg orally)
topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
462775|NCT00632411|B3|Baseline|Total|Total of all reporting groups
462776|NCT00632411|B2|Baseline|Reactive Group|"Participant will contact the research study staff to initiate sessions.
2 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.
Six sessions will be delivered to the participant as long as the participant calls to initiate the sessions.
Phone session 1 will focus on smoking reduction.
Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days.
Phone session 3 will focus on the first days after the quit date.
Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.
Phone session 5 will focus on short-term relapse prevention.
Phone session 6 will focus on long-term relapse prevention."
462777|NCT00632411|B1|Baseline|Proactive Group|"Research study staff will contact participant to initiate sessions.
8 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.
Six sessions will be proactively delivered to the participant.
Phone session 1 will focus on smoking reduction.
Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days.
Phone session 3 will focus on the first days after the quit date.
Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.
Phone session 5 will focus on short-term relapse prevention.
Phone session 6 will focus on long-term relapse prevention."
462778|NCT00632411|P2|Participant Flow|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.
Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
462779|NCT00632411|P1|Participant Flow|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.
Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
462780|NCT00632411|O2|Outcome|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.
Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
462781|NCT00632411|O1|Outcome|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.
Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
462782|NCT00632411|E2|Reported Event|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.
Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
462783|NCT00632411|E1|Reported Event|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.
Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
462784|NCT00632424|B4|Baseline|Total|Total of all reporting groups
462785|NCT00632424|B3|Baseline|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
462786|NCT00632424|B2|Baseline|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
462787|NCT00632424|B1|Baseline|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
462788|NCT00632424|P1|Participant Flow|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle.
462789|NCT00632424|O3|Outcome|Ixabepilone 50 mg/Dose|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
462790|NCT00632424|O2|Outcome|Ixabepilone 40 mg/Dose|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
462791|NCT00632424|O1|Outcome|Ixabepilone 30 mg/Dose|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
462792|NCT00632424|O3|Outcome|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
462793|NCT00632424|O2|Outcome|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
462794|NCT00632424|O1|Outcome|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
462795|NCT00632424|O3|Outcome|Ixabepilone 50 mg/Dose|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
462796|NCT00632424|O2|Outcome|Ixabepilone 40 mg/Dose|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
462797|NCT00632424|O1|Outcome|Ixabepilone 30 mg/Dose|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
462798|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
462799|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
462800|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
462801|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
462802|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
462803|NCT00632424|O3|Outcome|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
462804|NCT00632424|O2|Outcome|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
462805|NCT00632424|O1|Outcome|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
462806|NCT00632424|E3|Reported Event|Ixa 150 mg/Day|
462807|NCT00632424|E2|Reported Event|Ixa 120 mg/Day|
462808|NCT00632424|E1|Reported Event|Ixa 90 mg/Day|
462809|NCT00638183|B1|Baseline|Spiriva Treatment|Daily Therapy
462810|NCT00638183|P1|Participant Flow|Spiriva Treatment|Daily Therapy
462811|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
462812|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
462813|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
462814|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
462815|NCT00638183|E1|Reported Event|Spiriva Treatment|Daily Therapy
462816|NCT00638222|B4|Baseline|Total|Total of all reporting groups
462817|NCT00638222|B3|Baseline|All Study Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
462818|NCT00638222|B2|Baseline|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
462819|NCT00638222|B1|Baseline|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
462820|NCT00638222|P3|Participant Flow|All Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
462821|NCT00638222|P2|Participant Flow|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
462822|NCT00638222|P1|Participant Flow|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
463017|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462824|NCT00638222|O1|Outcome|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
462825|NCT00638222|E3|Reported Event|All Study Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
462826|NCT00638222|E2|Reported Event|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
462827|NCT00638222|E1|Reported Event|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
462828|NCT00638235|B10|Baseline|Total|Total of all reporting groups
462829|NCT00638235|B9|Baseline|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462830|NCT00638235|B8|Baseline|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
462831|NCT00638235|B7|Baseline|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462832|NCT00638235|B6|Baseline|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462833|NCT00638235|B5|Baseline|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462834|NCT00638235|B4|Baseline|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462835|NCT00638235|B3|Baseline|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse
462836|NCT00638235|B2|Baseline|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462837|NCT00638235|B1|Baseline|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462838|NCT00638235|P9|Participant Flow|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462839|NCT00638235|P8|Participant Flow|Phase VI (Elevate Anterior Gen 1, for Study Use Only, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
462840|NCT00638235|P7|Participant Flow|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462841|NCT00638235|P6|Participant Flow|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462842|NCT00638235|P5|Participant Flow|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462843|NCT00638235|P4|Participant Flow|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462844|NCT00638235|P3|Participant Flow|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462845|NCT00638235|P2|Participant Flow|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462846|NCT00638235|P1|Participant Flow|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462847|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462848|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
462849|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462850|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462851|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462852|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462853|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
462854|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
469007|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
462856|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462857|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
462858|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462859|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462860|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462861|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462862|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462863|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462864|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462865|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462866|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
462867|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462868|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462869|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462870|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462871|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
462872|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462873|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462874|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462875|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
462876|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462877|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462878|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462879|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462880|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462881|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462882|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462883|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462884|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
462885|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462886|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462983|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
462887|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462888|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462889|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
462890|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
464148|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
462892|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462893|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
462894|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462895|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462896|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462897|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462898|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462899|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462900|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462901|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462902|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, Fot PROPEL Study Use Only)
462903|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462904|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462905|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462906|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462907|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462908|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462909|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462910|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462911|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
462912|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462913|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462914|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462915|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462916|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462917|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462918|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462919|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462920|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
462921|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462922|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462923|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462989|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462924|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462925|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
462926|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462927|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462928|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462929|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
462930|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462931|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462932|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462933|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462934|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462935|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462936|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462937|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462938|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
462939|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462940|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462941|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462942|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462943|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IVmodels"
462944|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462945|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462946|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462947|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
462948|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462949|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462950|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462951|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462952|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462953|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462954|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462955|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
467416|NCT00654498|E1|Reported Event|Pramipexole|
462956|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
462957|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462958|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462959|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462960|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462961|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462962|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462963|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462964|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462965|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
462966|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462967|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462968|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462969|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462970|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462971|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462972|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462973|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462974|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
462975|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462976|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462977|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462978|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462979|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
462980|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462981|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462982|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462984|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462985|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462986|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462987|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462988|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462990|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
462991|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
462992|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
462993|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
462994|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
462995|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462996|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
462997|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
462998|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
462999|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463000|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463001|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463002|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463003|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463004|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463005|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463006|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
463007|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463008|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463009|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463010|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463011|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463012|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463013|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463014|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463015|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463016|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463018|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463019|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463020|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463021|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463022|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463023|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463024|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463025|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463026|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463027|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463028|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463029|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463030|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463031|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463032|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463033|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
463034|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463035|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463036|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463037|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463038|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463039|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463040|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463041|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463042|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463043|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463044|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463045|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463046|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463047|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463048|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463049|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463050|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463051|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463052|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463053|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463054|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463116|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463055|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463056|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463057|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463058|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463059|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463060|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
463061|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463062|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463063|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463064|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463065|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463066|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463067|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463068|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463069|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463070|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463071|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463072|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463073|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463074|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463075|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463076|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463077|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463078|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463079|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463080|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463081|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463207|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463082|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463083|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463084|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463117|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463085|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463086|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463087|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
463088|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463089|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463090|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463091|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463092|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463093|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463094|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463095|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463096|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463097|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463098|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463099|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463100|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463101|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463102|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463103|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463104|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463105|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463106|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463107|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463108|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463109|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463110|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463111|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463112|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463352|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463113|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463114|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
463115|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463118|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463119|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463120|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463121|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463122|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463123|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463124|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463125|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463126|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463127|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463128|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463129|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463130|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463131|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463132|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
463133|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463134|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463135|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463136|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463137|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463138|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463139|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463140|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463141|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463142|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463143|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463144|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463145|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463146|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463147|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463148|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463149|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463150|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
463151|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463152|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463153|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463154|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463155|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US & Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463156|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463157|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463158|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463159|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463160|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463161|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463162|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463163|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463164|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463165|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463166|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463167|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463168|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463169|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463170|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463171|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463172|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463173|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463174|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463175|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463439|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for disperse blue and the reference allergen
463176|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463177|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects had their 24M visit because next generation of Perigee was already under trial in Phase III/IV"
463178|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463179|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463243|NCT00638365|B4|Baseline|Total|Total of all reporting groups
463244|NCT00638365|B3|Baseline|KB001, 10 mg/kg|
463180|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463181|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463182|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463183|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463184|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463185|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463186|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
463187|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463188|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463189|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463190|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463191|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463192|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463193|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463194|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463195|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
463196|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463197|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463198|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463199|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463200|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463201|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463202|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463203|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463204|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463205|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463206|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463498|NCT00640926|E1|Reported Event|Radezolid 300 mg PO Daily (QD)|
463208|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463209|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463210|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463245|NCT00638365|B2|Baseline|KB001, 3 mg/kg|
463246|NCT00638365|B1|Baseline|Placebo|
463247|NCT00638365|P3|Participant Flow|KB001, 10 mg/kg|
463211|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463212|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463213|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463214|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463215|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463216|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463217|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
463218|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463219|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463220|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463221|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463222|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463223|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463224|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463225|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463226|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
463227|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463228|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463229|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463230|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463231|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
463232|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463233|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463234|NCT00638235|E9|Reported Event|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
463235|NCT00638235|E8|Reported Event|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
463236|NCT00638235|E7|Reported Event|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
463237|NCT00638235|E6|Reported Event|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
463238|NCT00638235|E5|Reported Event|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463239|NCT00638235|E4|Reported Event|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
463240|NCT00638235|E3|Reported Event|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
463241|NCT00638235|E2|Reported Event|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
463242|NCT00638235|E1|Reported Event|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
463256|NCT00638378|B1|Baseline|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
463257|NCT00638378|P1|Participant Flow|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
463258|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
463259|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
463260|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
463261|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
463262|NCT00638378|E1|Reported Event|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
463263|NCT00638443|B1|Baseline|All Study Participants|"Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days"
463264|NCT00638443|P2|Participant Flow|Diphenhydramine First, Pregabalin Second|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days; washout 7 days; Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
463265|NCT00638443|P1|Participant Flow|Pregabalin First, Diphenhydramine Second|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days; washout 7 days; Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463266|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463267|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
463268|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463269|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
463270|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463271|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
463272|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463273|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
463274|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463275|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
463276|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463277|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
463278|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463433|NCT00640614|O3|Outcome|Adhesion|Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.
463279|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
463280|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463281|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
463282|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463283|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
463284|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463285|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
463286|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
463287|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
463288|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
463289|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
463290|NCT00638443|E2|Reported Event|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
463291|NCT00638443|E1|Reported Event|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
463292|NCT00640393|B1|Baseline|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463293|NCT00640393|P3|Participant Flow|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463294|NCT00640393|P2|Participant Flow|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463295|NCT00640393|P1|Participant Flow|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463296|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463297|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463298|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463299|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463300|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463301|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463302|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463303|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463304|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463305|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463306|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463307|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463308|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463309|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463310|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463311|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463312|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463313|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463314|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463315|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463316|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463317|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463318|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463319|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463320|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463321|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463322|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463323|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463324|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463325|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463326|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463327|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463328|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463329|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463330|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463331|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463332|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463333|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463334|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463335|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463336|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463337|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463338|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463339|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463340|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463341|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463342|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463343|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463344|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463345|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463346|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463347|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463348|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463349|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463350|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463351|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463353|NCT00640393|E3|Reported Event|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
463354|NCT00640393|E2|Reported Event|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
463355|NCT00640393|E1|Reported Event|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
463356|NCT00640510|B3|Baseline|Total|Total of all reporting groups
463357|NCT00640510|B2|Baseline|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463405|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463358|NCT00640510|B1|Baseline|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463359|NCT00640510|P2|Participant Flow|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463360|NCT00640510|P1|Participant Flow|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463361|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463362|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463363|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463364|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463365|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463366|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463367|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463368|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463369|NCT00640510|E2|Reported Event|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463434|NCT00640614|O2|Outcome|Itching and Burning|Subject reported sensations of itching and burning were captured at day 2 following patch removal
463435|NCT00640614|O1|Outcome|Panel Irritation|Irritation from the test panel adhesive and/or tape was scored at day 2 following patch removal
463370|NCT00640510|E1|Reported Event|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
463371|NCT00640562|B3|Baseline|Total|Total of all reporting groups
463372|NCT00640562|B2|Baseline|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463449|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for gold sodium thiosulfate and reference allergen
463373|NCT00640562|B1|Baseline|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463374|NCT00640562|P2|Participant Flow|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463375|NCT00640562|P1|Participant Flow|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463376|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463377|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463378|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463379|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463380|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463381|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463382|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463383|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463384|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463385|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463386|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463387|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463388|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463448|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for gold sodium thiosulfate and the reference allergen
463389|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463390|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463391|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463392|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463393|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463394|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463395|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463396|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463397|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463398|NCT00640562|E2|Reported Event|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
463399|NCT00640562|E1|Reported Event|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
463400|NCT00640601|B1|Baseline|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463401|NCT00640601|P1|Participant Flow|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463402|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463436|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for bronopol and the reference allergen
463437|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for bronopol and reference allergen
463403|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463404|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463406|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463407|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463408|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463409|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463410|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463411|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463412|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463413|NCT00640601|E1|Reported Event|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
463414|NCT00640614|B3|Baseline|Total|Total of all reporting groups
463415|NCT00640614|B2|Baseline|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
463416|NCT00640614|B1|Baseline|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
463417|NCT00640614|P2|Participant Flow|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
463418|NCT00640614|P1|Participant Flow|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
463419|NCT00640614|O7|Outcome|Bronopol|Number of subjects who exhibit reactions 7-10 days after application
463420|NCT00640614|O6|Outcome|Disperse Blue|Number of subjects who exhibit reactions 7-10 days after application
463421|NCT00640614|O5|Outcome|Parthenolide|Number of subjects who exhibit reactions 7-10 days after application
463422|NCT00640614|O4|Outcome|Bacitracin|Number of subjects who exhibit reactions 7-10 days after application
463423|NCT00640614|O3|Outcome|Methyldibrono-glutaronitrile|Number of subjects who exhibit reactions 7-10 days after application
463424|NCT00640614|O2|Outcome|Hydrocortisone-17-Butyrate|Number of subjects who exhibit reactions 7-10 days after application
463425|NCT00640614|O1|Outcome|Gold Sodium Thiosulfate|Number of subjects who exhibit reactions 7-10 days after application
463426|NCT00640614|O7|Outcome|Bronopol|Number of subjects who exhibit reactions 7-10 days after application
463427|NCT00640614|O6|Outcome|Disperse Blue|Number of subjects who exhibit reactions 7-10 days after application
463428|NCT00640614|O5|Outcome|Parthenolide|Number of subjects who exhibit reactions 7-10 days after application
463429|NCT00640614|O4|Outcome|Bacitracin|Number of subjects who exhibit reactions 7-10 days after application
463430|NCT00640614|O3|Outcome|Methyldibrono-glutaronitrile|Number of subjects who exhibit reactions 7-10 days after application
463431|NCT00640614|O2|Outcome|Hydrocortisone-17-Butyrate|Number of subjects who exhibit reactions 7-10 days after application
463432|NCT00640614|O1|Outcome|Gold Sodium Thiosulfate|Number of subjects who exhibit reactions 7-10 days after application
469008|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
463440|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for parthenolide and the reference allergen
463441|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for parthenolide and reference allergen
463442|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for bacitracin and the reference allergen
463443|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for bacitracin and reference allergen
463444|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for methyldibromo-glutaronitrile and the reference allergen
463445|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for methyldibromo-glutaronitrile and reference allergen
463446|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for hydrocortisone-17-butyrate and the reference allergen
463447|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for hydrocortisone-17-butyrate and reference allergen
467417|NCT00654511|B5|Baseline|Total|Total of all reporting groups
463450|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
463451|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
463452|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
463453|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
463454|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
463455|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
463456|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
463457|NCT00640614|E2|Reported Event|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
463458|NCT00640614|E1|Reported Event|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
463459|NCT00640822|B4|Baseline|Total|Total of all reporting groups
463460|NCT00640822|B3|Baseline|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
463461|NCT00640822|B2|Baseline|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
463462|NCT00640822|B1|Baseline|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
463463|NCT00640822|P3|Participant Flow|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
463464|NCT00640822|P2|Participant Flow|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
463465|NCT00640822|P1|Participant Flow|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
463466|NCT00640822|O3|Outcome|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
463467|NCT00640822|O2|Outcome|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
463468|NCT00640822|O1|Outcome|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
463469|NCT00640822|E3|Reported Event|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
463470|NCT00640822|E2|Reported Event|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
463471|NCT00640822|E1|Reported Event|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
463472|NCT00640835|B3|Baseline|Total|Total of all reporting groups
463473|NCT00640835|B2|Baseline|Buprenorphine/Naloxone Film Strip Administered Buccally|
463474|NCT00640835|B1|Baseline|Buprenorphine/Naloxone Film Strip Administered Sublingually|
463475|NCT00640835|P2|Participant Flow|Buprenorphine/Naloxone Film Strip Administered Buccally|
463476|NCT00640835|P1|Participant Flow|Buprenorphine/Naloxone Film Strip Administered Sublingually|
463477|NCT00640835|O2|Outcome|Buprenorphine/Naloxone Film Strip Administered Buccally|
463478|NCT00640835|O1|Outcome|Buprenorphine/Naloxone Film Strip Administered Sublingually|
463479|NCT00640835|O2|Outcome|Buprenorphine/Naloxone Film Strip Administered Buccally|
463480|NCT00640835|O1|Outcome|Buprenorphine/Naloxone Film Strip Administered Sublingually|
463481|NCT00640835|E2|Reported Event|Buprenorphine/Naloxone Film Strip Administered Buccally|
463482|NCT00640835|E1|Reported Event|Buprenorphine/Naloxone Film Strip Administered Sublingually|
463483|NCT00640926|B4|Baseline|Total|Total of all reporting groups
463484|NCT00640926|B3|Baseline|Radezolid 450 mg PO Twice Daily (BID)|
463485|NCT00640926|B2|Baseline|Radezolid 450 mg PO Daily (QD)|
463486|NCT00640926|B1|Baseline|Radezolid 300 mg PO Daily (QD)|
463487|NCT00640926|P3|Participant Flow|Radezolid 450 mg PO Twice Daily (BID)|
463488|NCT00640926|P2|Participant Flow|Radezolid 450 mg PO Daily (QD)|
463489|NCT00640926|P1|Participant Flow|Radezolid 300 mg PO Daily (QD)|
463490|NCT00640926|O3|Outcome|Radezolid 450 mg PO Twice Daily (BID)|
463491|NCT00640926|O2|Outcome|Radezolid 450 mg PO Daily (QD)|
463492|NCT00640926|O1|Outcome|Radezolid 300 mg PO Daily (QD)|
463493|NCT00640926|O3|Outcome|Radezolid 450 mg PO Twice Daily (BID)|
463494|NCT00640926|O2|Outcome|Radezolid 450 mg PO Daily (QD)|
463495|NCT00640926|O1|Outcome|Radezolid 300 mg PO Daily (QD)|
463496|NCT00640926|E3|Reported Event|Radezolid 450 mg PO Twice Daily (BID)|
463497|NCT00640926|E2|Reported Event|Radezolid 450 mg PO Daily (QD)|
463499|NCT00640978|B1|Baseline|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
463500|NCT00640978|P1|Participant Flow|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
463501|NCT00640978|O1|Outcome|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
463502|NCT00640978|E1|Reported Event|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
463503|NCT00641043|B3|Baseline|Total|Total of all reporting groups
463504|NCT00641043|B2|Baseline|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463505|NCT00641043|B1|Baseline|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463506|NCT00641043|P2|Participant Flow|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463507|NCT00641043|P1|Participant Flow|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463508|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463509|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463510|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463511|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463512|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463513|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463514|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463515|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463516|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463517|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463518|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463519|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463520|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463521|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463522|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463523|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463524|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463525|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463526|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463527|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463528|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463529|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463530|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463531|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463532|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463533|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463534|NCT00641043|E2|Reported Event|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
463535|NCT00641043|E1|Reported Event|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
463536|NCT00641056|B3|Baseline|Total|Total of all reporting groups
463537|NCT00641056|B2|Baseline|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463538|NCT00641056|B1|Baseline|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463539|NCT00641056|P2|Participant Flow|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463540|NCT00641056|P1|Participant Flow|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463631|NCT00641563|P2|Participant Flow|Mida/Remi Followed by Dex/Remi|Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week
464268|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
463541|NCT00641056|O4|Outcome|Insulin Glargine No SU|Patients assigned to the Insulin Glargine No SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met only.
463542|NCT00641056|O3|Outcome|Exenatide Once Weekly No SU|Patients assigned to the Exenatide Once Weekly No SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met only.
463543|NCT00641056|O2|Outcome|Insulin Glargine With SU|Patients assigned to the Insulin Glargine with SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met+SU.
463544|NCT00641056|O1|Outcome|Exenatide Once Weekly With SU|Patients assigned to the Exenatide Once Weekly With SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met+SU.
463786|NCT00642278|E6|Reported Event|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
463545|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463546|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463547|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463548|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463549|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463550|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463551|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463552|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463553|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463554|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463555|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463556|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463557|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463558|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463559|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463560|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463561|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463562|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463563|NCT00641056|E2|Reported Event|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
463564|NCT00641056|E1|Reported Event|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
463565|NCT00641537|B6|Baseline|Total|Total of all reporting groups
463566|NCT00641537|B5|Baseline|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463567|NCT00641537|B4|Baseline|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463568|NCT00641537|B3|Baseline|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463569|NCT00641537|B2|Baseline|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463936|NCT00642616|O4|Outcome|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD
463570|NCT00641537|B1|Baseline|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463571|NCT00641537|P8|Participant Flow|Cladribine 5.25 mg/kg/No Treatment|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
463572|NCT00641537|P7|Participant Flow|Cladribine 3.5 mg/kg/No Treatment|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
463573|NCT00641537|P6|Participant Flow|Placebo/No Treatment|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
463574|NCT00641537|P5|Participant Flow|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463575|NCT00641537|P4|Participant Flow|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463576|NCT00641537|P3|Participant Flow|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463577|NCT00641537|P2|Participant Flow|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463578|NCT00641537|P1|Participant Flow|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463579|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463580|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463581|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463582|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
464269|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
463583|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463612|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463584|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463585|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463586|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463587|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463588|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463589|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463590|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463591|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463592|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463593|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463594|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463595|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463596|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463632|NCT00641563|P1|Participant Flow|Dex/Remi Followed by Mida/Remi|Sedation with dexmedetomidine and remifentanil followed by sedation with midazolam and remifentanil separated by one week
463633|NCT00641563|O2|Outcome|Mida/Remi|Sedation with midazolam and remifentanil
463597|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463598|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463599|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463600|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463601|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463602|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463603|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463604|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463605|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463606|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463607|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463608|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463609|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463610|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463634|NCT00641563|O1|Outcome|Dex/Remi|Sedation with dexmedetomidine and remifentanil
463635|NCT00641563|O2|Outcome|Mida/Remi|Sedation with midazolam and remifentanil
469009|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
463611|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463613|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463614|NCT00641537|E16|Reported Event|Cladribine 5.25 mg/kg/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24 weeks in supplemental follow-up period.
463615|NCT00641537|E15|Reported Event|Cladribine 3.5 mg/kg/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24 weeks in supplemental follow-up period.
463616|NCT00641537|E14|Reported Event|Placebo/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24-Week supplemental follow-up period.
463617|NCT00641537|E13|Reported Event|Placebo/Cladribine Low Dose (PPLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
463618|NCT00641537|E12|Reported Event|Cladribine High/Low Dose (HLLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
463619|NCT00641537|E11|Reported Event|Cladribine Low/Low Dose (LLLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
463620|NCT00641537|E10|Reported Event|Cladribine High Dose/Placebo (HLPP) (24-week Follow-up Period|Participants who received placebo matched to cladribine tablet during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
463621|NCT00641537|E9|Reported Event|Cladribine Low/Placebo (LLPP) (24-week Follow-up Period)|Participants who received placebo matched to cladribine tablet during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
463622|NCT00641537|E8|Reported Event|Cladribine 5.25 mg/kg/No Treatment|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
463623|NCT00641537|E7|Reported Event|Cladribine 3.5 mg/kg/No Treatment|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
463624|NCT00641537|E6|Reported Event|Placebo/No Treatment|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
463625|NCT00641537|E5|Reported Event|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463626|NCT00641537|E4|Reported Event|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463627|NCT00641537|E3|Reported Event|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463628|NCT00641537|E2|Reported Event|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463629|NCT00641537|E1|Reported Event|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
463630|NCT00641563|B1|Baseline|All Study Participants|Both arms combined
463637|NCT00641563|E2|Reported Event|Mida/Remi Followed by Dex/Remi|Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week
463638|NCT00641563|E1|Reported Event|Dex/Remi|Sedation with dexmedetomidine and remifentanil
463643|NCT00641667|B1|Baseline|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
463711|NCT00642174|B3|Baseline|Total|Total of all reporting groups
464149|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
463644|NCT00641667|P1|Participant Flow|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
463645|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
463646|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
463647|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
463648|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
463649|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
463650|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
463651|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
463652|NCT00641667|E1|Reported Event|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
463653|NCT00641706|B3|Baseline|Total|Total of all reporting groups
463654|NCT00641706|B2|Baseline|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery
bortezomib : Given IV
vorinostat : Given orally"
463655|NCT00641706|B1|Baseline|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally"
463656|NCT00641706|P2|Participant Flow|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery
bortezomib : Given IV
vorinostat : Given orally"
463657|NCT00641706|P1|Participant Flow|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally"
463658|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
463659|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally"
463660|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
463661|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally"
463662|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
463663|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally"
463664|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
463665|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally"
463666|NCT00641706|E2|Reported Event|Arm B (Undergoing Surgery)|vorinostat : Given orally
463667|NCT00641706|E1|Reported Event|Arm A (Not Undergoing Surgery)|vorinostat : Given orally
463668|NCT00641719|B3|Baseline|Total|Total of all reporting groups
463669|NCT00641719|B2|Baseline|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463670|NCT00641719|B1|Baseline|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463671|NCT00641719|P2|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463672|NCT00641719|P1|Participant Flow|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463673|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463674|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463675|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463676|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463677|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463678|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463679|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463680|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463681|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463682|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463683|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463684|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463685|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463686|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463687|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463688|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463689|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463690|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463691|NCT00641719|E2|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
463692|NCT00641719|E1|Reported Event|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
463693|NCT00641745|B3|Baseline|Total|Total of all reporting groups
463694|NCT00641745|B2|Baseline|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
463695|NCT00641745|B1|Baseline|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
463696|NCT00641745|P2|Participant Flow|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
463697|NCT00641745|P1|Participant Flow|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
463698|NCT00641745|O2|Outcome|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
463699|NCT00641745|O1|Outcome|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
463700|NCT00641745|E2|Reported Event|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
463701|NCT00641745|E1|Reported Event|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
463702|NCT00641862|B3|Baseline|Total|Total of all reporting groups
463703|NCT00641862|B2|Baseline|Placebo|"Placebo
Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
463704|NCT00641862|B1|Baseline|Vitamin B12|"Vitamin B12
Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
463705|NCT00641862|P2|Participant Flow|Placebo|"Placebo
Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
463706|NCT00641862|P1|Participant Flow|Vitamin B12|"Vitamin B12
Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
463707|NCT00641862|O2|Outcome|Placebo|"Placebo
Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
463708|NCT00641862|O1|Outcome|Vitamin B12|"Vitamin B12
Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
463709|NCT00641862|E2|Reported Event|Placebo|"Placebo
Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
463710|NCT00641862|E1|Reported Event|Vitamin B12|"Vitamin B12
Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
463712|NCT00642174|B2|Baseline|Clopidogrel Then Prasugrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
463713|NCT00642174|B1|Baseline|Prasugrel Then Clopidogrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
463714|NCT00642174|P2|Participant Flow|Clopidogrel Then Prasugrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
463715|NCT00642174|P1|Participant Flow|Prasugrel Then Clopidogrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
463716|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
463717|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
463718|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
463719|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
463720|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
463721|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
463722|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
463723|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
463724|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
463725|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
463726|NCT00642174|E2|Reported Event|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
463727|NCT00642174|E1|Reported Event|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
463728|NCT00642278|B8|Baseline|Total|Total of all reporting groups
463729|NCT00642278|B7|Baseline|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463730|NCT00642278|B6|Baseline|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
463731|NCT00642278|B5|Baseline|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463732|NCT00642278|B4|Baseline|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463733|NCT00642278|B3|Baseline|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463734|NCT00642278|B2|Baseline|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463735|NCT00642278|B1|Baseline|Placebo|Each patient received matching placebo twice daily for 12 weeks.
463736|NCT00642278|P7|Participant Flow|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463737|NCT00642278|P6|Participant Flow|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
463738|NCT00642278|P5|Participant Flow|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463739|NCT00642278|P4|Participant Flow|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463740|NCT00642278|P3|Participant Flow|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463928|NCT00642616|B4|Baseline|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD.
463741|NCT00642278|P2|Participant Flow|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463742|NCT00642278|P1|Participant Flow|Placebo|Each patient received matching placebo twice daily for 12 weeks.
463743|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463744|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
463745|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463746|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463747|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463748|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463749|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
463750|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463751|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
463752|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463753|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463754|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463755|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463756|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
463757|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463758|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
463759|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463760|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463761|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463762|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463763|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
463764|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463765|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
463766|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463767|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463768|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463769|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463770|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
463771|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463772|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
463773|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463774|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463775|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463776|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463777|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
463778|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463779|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
463780|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463781|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463782|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463783|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463784|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
463785|NCT00642278|E7|Reported Event|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463787|NCT00642278|E5|Reported Event|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463788|NCT00642278|E4|Reported Event|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463789|NCT00642278|E3|Reported Event|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463790|NCT00642278|E2|Reported Event|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
463791|NCT00642278|E1|Reported Event|Placebo|Each patient received matching placebo twice daily for 12 weeks.
463792|NCT00642304|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
463793|NCT00642304|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously (SC) every four weeks up to Week 20. The starting dose was 120, 200 or 300 micrograms (mcg) based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the hemoglobin (Hb) levels.
463794|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
463795|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
463796|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
463797|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
463798|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
463799|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
463800|NCT00642304|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
463801|NCT00642356|B3|Baseline|Total|Total of all reporting groups
463802|NCT00642356|B2|Baseline|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
463803|NCT00642356|B1|Baseline|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
463804|NCT00642356|P2|Participant Flow|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
463929|NCT00642616|B3|Baseline|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with COPD
463805|NCT00642356|P1|Participant Flow|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
463806|NCT00642356|O2|Outcome|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
463807|NCT00642356|O1|Outcome|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
463808|NCT00642356|O2|Outcome|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
463937|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
463809|NCT00642356|O1|Outcome|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
463810|NCT00642356|E2|Reported Event|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
463811|NCT00642356|E1|Reported Event|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
463812|NCT00642369|B3|Baseline|Total|Total of all reporting groups
463813|NCT00642369|B2|Baseline|Haloperidol|haloperidol treatment (6-40mg/day) in 28 days
463814|NCT00642369|B1|Baseline|Quetiapine Fumarate|quetiapine fumarate treatment (200-750mg/day) in 28 days
463815|NCT00642369|P2|Participant Flow|Haloperidol|slow wave sleep% in haloperidol treatment group
463816|NCT00642369|P1|Participant Flow|Quetiapine Fumarate|slow wave sleep% and rapid eye movement sleepin quetiapine fumarate treatment group
463817|NCT00642369|O2|Outcome|Haloperidol|percentage of rapid eye movement sleep in haloperidol group
463818|NCT00642369|O1|Outcome|Quetiapine Fumarate|percentage of rapid eye movement sleep in quetiapine fumarate group
463819|NCT00642369|O2|Outcome|Haloperidol|percentage of slow wave sleep in haloperidol group
463820|NCT00642369|O1|Outcome|Quetiapine Fumarate|percentage of slow wave sleep in quetiapine fumarate group
463821|NCT00642369|E2|Reported Event|Haloperidol|haloperidol treatment (6-40mg/day) in 28 days
463822|NCT00642369|E1|Reported Event|Quetiapine Fumarate|quetiapine fumarate treatment (200-750mg/day) in 28 days
463823|NCT00642382|B3|Baseline|Total|Total of all reporting groups
463824|NCT00642382|B2|Baseline|Control|"Normal Saline
Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
463825|NCT00642382|B1|Baseline|Active|"Agilus (Hyaluronic Acid)
Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
463826|NCT00642382|P2|Participant Flow|Control|"Normal Saline
Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
463827|NCT00642382|P1|Participant Flow|Active|"Agilus (Hyaluronic Acid)
Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
463828|NCT00642382|O2|Outcome|Control|"Normal Saline
Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
463829|NCT00642382|O1|Outcome|Active|"Agilus (Hyaluronic Acid)
Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
463830|NCT00642382|E2|Reported Event|Control|"Normal Saline
Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
463831|NCT00642382|E1|Reported Event|Active|"Agilus (Hyaluronic Acid)
Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
463832|NCT00642460|B3|Baseline|Total|Total of all reporting groups
463833|NCT00642460|B2|Baseline|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463834|NCT00642460|B1|Baseline|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
463835|NCT00642460|P6|Participant Flow|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463836|NCT00642460|P5|Participant Flow|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463837|NCT00642460|P4|Participant Flow|Tocilizumab Switchers|"Tocilizumab Switchers includes all participants who changed their dose either Tocilizumab 8 mg/kg or 12 mg/kg intravenous (iv) every 2 weeks in Part II.
Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
463930|NCT00642616|B2|Baseline|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
463838|NCT00642460|P3|Participant Flow|Placebo|Placebo iv every 2 weeks for 12 weeks in Part 1. Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
463839|NCT00642460|P2|Participant Flow|Tocilizumab_12 mg/kg|"Tocilizumab 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463840|NCT00642460|P1|Participant Flow|Tocilizumab_8 mg/kg|"Tocilizumab 8 mg/kg (for patients ≥30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
463841|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463938|NCT00642616|O2|Outcome|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
463842|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463843|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463844|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463845|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463846|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463847|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463848|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463849|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463850|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463851|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463852|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463853|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463854|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463855|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463856|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463857|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463858|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463859|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463931|NCT00642616|B1|Baseline|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with Asthma
463860|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463861|NCT00642460|O1|Outcome|All Participants Treated With Tocilizumab|"Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463862|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463939|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
469040|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
463863|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463864|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463865|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463866|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463867|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463868|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463869|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463870|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463871|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463872|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463873|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463874|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463875|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463876|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463877|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463878|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463879|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463880|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463881|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463882|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463883|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
464134|NCT00635479|O2|Outcome|Gauze Dressing|"Gauze Dressing
Gauze dressing: Gauze dressing for surgical incision"
463884|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463885|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463886|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463887|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463888|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463889|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463890|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463891|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463892|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463893|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463894|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463895|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463896|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463897|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463898|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463899|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463900|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463901|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
463902|NCT00642460|E1|Reported Event|All Tocilizumab (Part I, Part II and Part III)|Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
463903|NCT00642473|B3|Baseline|Total|Total of all reporting groups
463904|NCT00642473|B2|Baseline|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
463905|NCT00642473|B1|Baseline|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
463906|NCT00642473|P2|Participant Flow|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
463907|NCT00642473|P1|Participant Flow|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 milligrams (mg) orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
463908|NCT00642473|O4|Outcome|Right Side - Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash.
463909|NCT00642473|O3|Outcome|Left Side - Treatment (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the treatment of erlotinib associated rash.
463940|NCT00642616|O4|Outcome|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
464150|NCT00635492|O1|Outcome|Insulin Cohort|insulin at a dose selected by the HCP and patient
463910|NCT00642473|O2|Outcome|Right Side - Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash.
463911|NCT00642473|O1|Outcome|Left Side - Prevention (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the prevention of erlotinib associated rash.
463912|NCT00642473|O4|Outcome|Right Side - Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash.
463913|NCT00642473|O3|Outcome|Left Side - Treatment (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the treatment of erlotinib associated rash.
463914|NCT00642473|O2|Outcome|Right Side - Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash.
463915|NCT00642473|O1|Outcome|Left Side - Prevention (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the prevention of erlotinib associated rash .
463916|NCT00642473|E2|Reported Event|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
463917|NCT00642473|E1|Reported Event|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
463918|NCT00642603|B3|Baseline|Total|Total of all reporting groups
463919|NCT00642603|B2|Baseline|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
463920|NCT00642603|B1|Baseline|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
463921|NCT00642603|P2|Participant Flow|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
463922|NCT00642603|P1|Participant Flow|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
463923|NCT00642603|O2|Outcome|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
463924|NCT00642603|O1|Outcome|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
463925|NCT00642603|E2|Reported Event|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
463926|NCT00642603|E1|Reported Event|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
463927|NCT00642616|B5|Baseline|Total|Total of all reporting groups
463932|NCT00642616|P4|Participant Flow|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
463933|NCT00642616|P3|Participant Flow|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
463934|NCT00642616|P2|Participant Flow|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
463935|NCT00642616|P1|Participant Flow|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
463941|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
463942|NCT00642616|O2|Outcome|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
463943|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
463944|NCT00642616|O4|Outcome|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
463945|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
463946|NCT00642616|O2|Outcome|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
463947|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
463948|NCT00642616|O4|Outcome|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD
463949|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
463950|NCT00642616|O2|Outcome|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
463951|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
463952|NCT00642616|E4|Reported Event|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
463953|NCT00642616|E3|Reported Event|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
463954|NCT00642616|E2|Reported Event|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
463955|NCT00642616|E1|Reported Event|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
463956|NCT00642642|B1|Baseline|Autologous Fibroblasts and Placebo|Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
463957|NCT00642642|P1|Participant Flow|Autologous Fibroblasts and Placebo|Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
463958|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks randomized to receive placebo treatment
463959|NCT00642642|O1|Outcome|Autologous Fibroblast Cheeks|Cheeks randomized to receive autologous fibroblast treatment
463960|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
463961|NCT00642642|O1|Outcome|Autologous Fibroblasts Cheeks|Cheeks treated with autologous fibroblasts (azficel-T)
463962|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
463963|NCT00642642|O1|Outcome|Autologous Fibroblast Cheeks|Cheeks treated with autologous fibroblasts
463964|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
463965|NCT00642642|O1|Outcome|Autologous Fibroblasts Cheeks|Cheeks treated with autologous fibroblasts (azficel-T)
463966|NCT00642642|E3|Reported Event|Non-treatment Area Adverse Events|Systemic adverse events and adverse events that occured outside of the study treatment area will be reported in this group
463967|NCT00642642|E2|Reported Event|Placebo Cheeks|Cheeks randomized to receive placebo treatment
463968|NCT00642642|E1|Reported Event|Autologous Fibroblast Cheeks|Cheeks randomized to receive autologous fibroblast treatment
463969|NCT00642668|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
463970|NCT00642668|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
463971|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
464022|NCT00642759|O1|Outcome|Chemotherapy|"Carboplatin, nab-paclitaxel, and bevacizumab
carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles
Nab-paclitaxel: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles
Bevacizumab: IV infusion"
463972|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
463973|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
463974|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
463975|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
463976|NCT00642668|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
463977|NCT00642694|B3|Baseline|Total|Total of all reporting groups
463978|NCT00642694|B2|Baseline|Escitalopram + Placebo|Placebo augmentation
463979|NCT00642694|B1|Baseline|Escitalopram + Ramelteon|active augmentation
463980|NCT00642694|P2|Participant Flow|Escitalopram + Placebo|Placebo augmentation
463981|NCT00642694|P1|Participant Flow|Escitalopram + Ramelteon|active augmentation
463982|NCT00642694|O2|Outcome|Escitalopram + Placebo|control group
463983|NCT00642694|O1|Outcome|Escitalopram + Ramelteon|active augmentation
463984|NCT00642694|O2|Outcome|Escitalopram + Placebp|control group
463985|NCT00642694|O1|Outcome|Escitalopram + Ramelteon|active augmentation
463986|NCT00642694|E2|Reported Event|Escitalopram + Placebo|Placebo augmentation
463987|NCT00642694|E1|Reported Event|Escitalopram + Ramelteon|active augmentation
463988|NCT00642707|B5|Baseline|Total|Total of all reporting groups
463989|NCT00642707|B4|Baseline|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
463990|NCT00642707|B3|Baseline|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
463991|NCT00642707|B2|Baseline|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
463992|NCT00642707|B1|Baseline|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
463993|NCT00642707|P4|Participant Flow|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
463994|NCT00642707|P3|Participant Flow|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
463995|NCT00642707|P2|Participant Flow|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
463996|NCT00642707|P1|Participant Flow|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
463997|NCT00642707|O4|Outcome|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
463998|NCT00642707|O3|Outcome|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
463999|NCT00642707|O2|Outcome|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
464000|NCT00642707|O1|Outcome|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
464001|NCT00642707|E4|Reported Event|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
464002|NCT00642707|E3|Reported Event|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
464003|NCT00642707|E2|Reported Event|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
464004|NCT00642707|E1|Reported Event|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
464005|NCT00642746|B3|Baseline|Total|Total of all reporting groups
464006|NCT00642746|B2|Baseline|FOLFOX With Erlotinib|
464007|NCT00642746|B1|Baseline|FOLFIRI With Erlotinib|
464008|NCT00642746|P2|Participant Flow|FOLFOX With Erlotinib|
464009|NCT00642746|P1|Participant Flow|FOLFIRI With Erlotinib|
464010|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
464011|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
464012|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
464013|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
464014|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
464015|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
464016|NCT00642746|E2|Reported Event|FOLFOX With Erlotinib|
464017|NCT00642746|E1|Reported Event|FOLFIRI With Erlotinib|
464018|NCT00642759|B1|Baseline|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles
Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles
Bevacizumab"
464019|NCT00642759|P1|Participant Flow|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles
Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles
Bevacizumab"
464020|NCT00642759|O1|Outcome|Chemotherapy|"Carboplatin, nab-paclitaxel, and bevacizumab
carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles
Nab-paclitaxel: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles
Bevacizumab: IV infusion"
464021|NCT00642759|O1|Outcome|Chemotherapy|"Carboplatin, nab-paclitaxel, and bevacizumab
carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles
Nab-paclitaxel: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles
Bevacizumab: IV infusion"
464133|NCT00635479|P1|Participant Flow|VAC Device|"Vacuum Assisted Closure (VAC) device
Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
464023|NCT00642759|O1|Outcome|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles
Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles
Bevacizumab"
464024|NCT00642759|E1|Reported Event|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles
Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles
Bevacizumab"
464025|NCT00642772|B1|Baseline|Group Physical Therapy|"Group Physical Therapy Intervention
Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
464026|NCT00642772|P1|Participant Flow|Group Physical Therapy|"Group Physical Therapy Intervention
Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
464151|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464027|NCT00642772|O1|Outcome|Group Physical Therapy|"Group Physical Therapy Intervention
Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
464028|NCT00642772|E1|Reported Event|Group Physical Therapy|"Group Physical Therapy Intervention
Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
464029|NCT00642811|B7|Baseline|Total|Total of all reporting groups
464030|NCT00642811|B6|Baseline|Clopidogrel Responders - Ticagrelor to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464031|NCT00642811|B5|Baseline|Clopidogrel Responders - Ticagrelor to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464032|NCT00642811|B4|Baseline|Clopidogrel Responders - Clopidogrel to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464033|NCT00642811|B3|Baseline|Clopidogrel Responders - Clopidogrel to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464034|NCT00642811|B2|Baseline|Clopidogrel Non-responders - Ticagrelor to Clopidogrel|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464035|NCT00642811|B1|Baseline|Clopidogrel Non-responders - Clopidogrel to Ticagrelor|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464036|NCT00642811|P6|Participant Flow|Clopidogrel Responders - Ticagrelor to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; stay on ticagrelor 90 mg twice daily (bd) for 2 weeks.
464037|NCT00642811|P5|Participant Flow|Clopidogrel Responders - Ticagrelor to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.
464038|NCT00642811|P4|Participant Flow|Clopidogrel Responders - Clopidogrel to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.
464039|NCT00642811|P3|Participant Flow|Clopidogrel Responders - Clopidogrel to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; stay on clopidogrel 75 mg once daily (od) for 2 weeks
464040|NCT00642811|P2|Participant Flow|Clopidogrel Non-responders - Ticagrelor to Clopidogrel|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.
464041|NCT00642811|P1|Participant Flow|Clopidogrel Non-responders - Clopidogrel to Ticagrelor|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.
464042|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464043|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464044|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464045|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464046|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464047|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464048|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464049|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464050|NCT00642811|O2|Outcome|Non-responder: Clopidogrel|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
469041|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
464051|NCT00642811|O1|Outcome|Non-responder: Ticagrelor|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464052|NCT00642811|O2|Outcome|Non-responder: Clopidogrel|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464053|NCT00642811|O1|Outcome|Non-responder: Ticagrelor|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
464054|NCT00642811|E8|Reported Event|Clop. Responders/Switching Period: Clopidogrel-Ticagrelor|included responders exposed to clopidogrel switching to ticagrelor on Day 15.
464055|NCT00642811|E7|Reported Event|Clop. Responders/Switching Period: Ticagrelor-Clopidogrel|included responders exposed to ticagrelor switching to clopidogrel on Day 15.
464056|NCT00642811|E6|Reported Event|Clop. Responders/Non-Switching Period: Clopidogrel|included responders exposed to clopidogrel on Day 1-14, Day 16-28.
464057|NCT00642811|E5|Reported Event|Clop. Responders/Non-Switching Period: Ticagrelor|included responders exposed to ticagrelor on Day 1-14, Day 16-28.
464058|NCT00642811|E4|Reported Event|Clop. Non-Responders/Switching Period: Clopidogrel-Ticagrelor|included non-responders exposed to clopidogrel switching to ticagrelor on Day 15.
464059|NCT00642811|E3|Reported Event|Clop. Non-Responders/Switching Period:Ticagrelor-Clopidogrel|included non-responders exposed to ticagrelor switching to clopidogrel on Day 15.
464060|NCT00642811|E2|Reported Event|Clopidogrel Non-Responders/Non-Switching Period: Clopidogrel|included non-responders exposed to clopidogrel on Day 1-14, Day 16-28.
464061|NCT00642811|E1|Reported Event|Clopidogrel Non-Responders/Non-Switching Period: Ticagrelor|included non-responders exposed to ticagrelor on Day 1-14, Day 16-28.
464062|NCT00635349|B3|Baseline|Total|Total of all reporting groups
464063|NCT00635349|B2|Baseline|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
464064|NCT00635349|B1|Baseline|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
464065|NCT00635349|P2|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
464066|NCT00635349|P1|Participant Flow|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
464067|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
464068|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
464102|NCT00635427|B4|Baseline|VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg) HGT-GCB-039|Imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
464103|NCT00635427|B3|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (60U/kg) HGT-GCB-039)|VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631).
464069|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
464070|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
464085|NCT00635362|B1|Baseline|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
464071|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
464072|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
464073|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
464074|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
464075|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
464076|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
464077|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
464078|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
464079|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
464080|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
464081|NCT00635349|E2|Reported Event|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
464104|NCT00635427|B2|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (60 U/kg)-TKT032)|VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625).
464260|NCT00642993|B2|Baseline|Placebo|Placebo capsules, administered orally, once daily
464082|NCT00635349|E1|Reported Event|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
464083|NCT00635362|B3|Baseline|Total|Total of all reporting groups
464084|NCT00635362|B2|Baseline|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
464086|NCT00635362|P2|Participant Flow|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
464087|NCT00635362|P1|Participant Flow|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
464088|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
464089|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
464090|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
464091|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
464092|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
464093|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
464094|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
464095|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
464096|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
464097|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
464098|NCT00635362|E2|Reported Event|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
464099|NCT00635362|E1|Reported Event|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
464100|NCT00635427|B6|Baseline|Total|Total of all reporting groups
464101|NCT00635427|B5|Baseline|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
464261|NCT00642993|B1|Baseline|SCH 497079|SCH 497079, administered orally, once daily
464105|NCT00635427|B1|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg)-TKT032)|VPRIV 45 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044.
464106|NCT00635427|P5|Participant Flow|VPRIV 15-60 U/kg (Parent Study VPRIV(15-60 U/kg)TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647) and continued in HGT-GCB-044 at the same dose as prescribed in TKT034
464107|NCT00635427|P4|Participant Flow|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg)HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched 60 U/kg VPRIV in HGT-GCB-044
464108|NCT00635427|P3|Participant Flow|VPRIV 60 U/kg (Parent Study- VPRIV (60U/kg) HGT-GCB-039)|VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)
464109|NCT00635427|P2|Participant Flow|VPRIV 60 U/kg (Parent Study- VPRIV (60 U/kg)-TKT032)|VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625)
464110|NCT00635427|P1|Participant Flow|VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg) -TKT032)|VPRIV 45 U/kg, IV, every other week (EOW) for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044
464146|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
464111|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
464112|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
464113|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:
VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
464114|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
464115|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
464116|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:
VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
464117|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
464118|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
464119|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:
VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
464120|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
464121|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
464122|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:
VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
464123|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
464124|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg)HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
464125|NCT00635427|O1|Outcome|VPRIV 60 U/kg(Parent Study VPRIV(45 or 60 U/kg) TKT032,GCB039)|"This is the overall velaglucerase alfa group consisting of the following population:
VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
464126|NCT00635427|E3|Reported Event|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
464127|NCT00635427|E2|Reported Event|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:
VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
464128|NCT00635427|E1|Reported Event|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
464129|NCT00635479|B3|Baseline|Total|Total of all reporting groups
464130|NCT00635479|B2|Baseline|Gauze Dressing|"Gauze Dressing
Gauze dressing: Gauze dressing for surgical incision"
464131|NCT00635479|B1|Baseline|VAC Device|"Vacuum Assisted Closure (VAC) device
Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
464132|NCT00635479|P2|Participant Flow|Gauze Dressing|"Gauze Dressing
Gauze dressing: Gauze dressing for surgical incision"
464135|NCT00635479|O1|Outcome|VAC Device|"Vacuum Assisted Closure (VAC) device
Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
464136|NCT00635479|E2|Reported Event|Gauze Dressing|"Gauze Dressing
Gauze dressing: Gauze dressing for surgical incision"
464137|NCT00635479|E1|Reported Event|VAC Device|"Vacuum Assisted Closure (VAC) device
Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
464138|NCT00635492|B3|Baseline|Total|Total of all reporting groups
464139|NCT00635492|B2|Baseline|Insulin|Insulin at a dose selected by the HCP and patient
464140|NCT00635492|B1|Baseline|Exenatide BID|Daily dose ranging from 5-20 ug
464141|NCT00635492|P2|Participant Flow|Insulin|Insulin at a dose selected by the health care provided (HCP) and patient
464142|NCT00635492|P1|Participant Flow|Exenatide BID|Daily dose ranging from 5-20 mcg
464143|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464144|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
464145|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464152|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
464153|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464154|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
464155|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464156|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
464157|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464158|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
464159|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464160|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
464161|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464162|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
464163|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464164|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
464165|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464166|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
464167|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464168|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
464169|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464170|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
464171|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464172|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
464173|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464174|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
464175|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464176|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
464177|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464178|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
464179|NCT00635492|O2|Outcome|Insulin|Insulin at a dose selected by the HCP and patient
464180|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20mcg/day
464181|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
464182|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
464183|NCT00635492|E2|Reported Event|Insulin|Insulin at a dose selected by the HCP and patient
464184|NCT00635492|E1|Reported Event|Exenatide BID|Daily dose ranging from 5-20 ug
464185|NCT00635570|B3|Baseline|Total|Total of all reporting groups
464186|NCT00635570|B2|Baseline|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
464187|NCT00635570|B1|Baseline|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
464188|NCT00635570|P2|Participant Flow|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
464189|NCT00635570|P1|Participant Flow|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
464190|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
464191|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
464192|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
464193|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
464194|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
464195|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
464196|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
464197|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
464198|NCT00635570|E2|Reported Event|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
464199|NCT00635570|E1|Reported Event|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
464200|NCT00635609|B3|Baseline|Total|Total of all reporting groups
464201|NCT00635609|B2|Baseline|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
464202|NCT00635609|B1|Baseline|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
464203|NCT00635609|P2|Participant Flow|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
464204|NCT00635609|P1|Participant Flow|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
464205|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
464206|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
464207|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
464208|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
464209|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
464210|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
464211|NCT00635609|E2|Reported Event|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
464212|NCT00635609|E1|Reported Event|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
464233|NCT00642902|B2|Baseline|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
464213|NCT00635648|B1|Baseline|Caspofungin 50 mg q.d. Intravenous (IV)|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.
After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
464214|NCT00635648|P1|Participant Flow|Caspofungin 50 mg q.d. Intravenous (IV)|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.
After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
464215|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.
After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
464216|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.
After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
464217|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.
After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
464218|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.
After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
464219|NCT00635648|E1|Reported Event|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.
After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
464220|NCT00642850|B1|Baseline|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
464221|NCT00642850|P1|Participant Flow|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
464222|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
464223|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
464224|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
464225|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
464262|NCT00642993|P2|Participant Flow|Placebo|Placebo capsules, administered orally, once daily
469010|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
464226|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
464227|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
464228|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
464229|NCT00642850|E1|Reported Event|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
464230|NCT00642902|B5|Baseline|Total|Total of all reporting groups
464231|NCT00642902|B4|Baseline|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
464232|NCT00642902|B3|Baseline|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
469042|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
464234|NCT00642902|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
464235|NCT00642902|P4|Participant Flow|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
464236|NCT00642902|P3|Participant Flow|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
464237|NCT00642902|P2|Participant Flow|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
464238|NCT00642902|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
464239|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
464240|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
464241|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
464242|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
464243|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
464244|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
464245|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
464246|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
464247|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
464248|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
464249|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
464250|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
464251|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
464252|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
464253|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
464254|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
464255|NCT00642902|E4|Reported Event|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
464256|NCT00642902|E3|Reported Event|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
464257|NCT00642902|E2|Reported Event|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
464258|NCT00642902|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
464259|NCT00642993|B3|Baseline|Total|Total of all reporting groups
464270|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
464271|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
464272|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
464273|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
464274|NCT00642993|E2|Reported Event|Placebo|Placebo capsules, administered orally, once daily
464275|NCT00642993|E1|Reported Event|SCH 497079|SCH 497079, administered orally, once daily
464276|NCT00643006|B3|Baseline|Total|Total of all reporting groups
464277|NCT00643006|B2|Baseline|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
464278|NCT00643006|B1|Baseline|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
464279|NCT00643006|P2|Participant Flow|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
464280|NCT00643006|P1|Participant Flow|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
464281|NCT00643006|O2|Outcome|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
464282|NCT00643006|O1|Outcome|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
464283|NCT00643006|O2|Outcome|Arm B. Active Comparator|The active comparison group participated in low-intensive walks.
464284|NCT00643006|O1|Outcome|Arm A. Exercise|The intervention group participated in Nordic walking
464285|NCT00643006|E2|Reported Event|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
464286|NCT00643006|E1|Reported Event|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
464287|NCT00643097|B4|Baseline|Total|Total of all reporting groups
464288|NCT00643097|B3|Baseline|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
464289|NCT00643097|B2|Baseline|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
464290|NCT00643097|B1|Baseline|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
464291|NCT00643097|P3|Participant Flow|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
464292|NCT00643097|P2|Participant Flow|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
464293|NCT00643097|P1|Participant Flow|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
464294|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
464295|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
464296|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
464297|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
464522|NCT00646646|O1|Outcome|Dexmedetomidine|"sedative
dexmedetomidine : Sedative"
464298|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
464299|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
464300|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
464323|NCT00645567|O2|Outcome|Standard Transfer Board|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study, but verifiable data is not available for any of the participants.
464353|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
469043|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
464301|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
464302|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
464303|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
464304|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
464305|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
464306|NCT00643097|E3|Reported Event|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
464307|NCT00643097|E2|Reported Event|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
464308|NCT00643097|E1|Reported Event|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
464309|NCT00645528|B1|Baseline|Insulin Education Class Participants|"Participation in an insulin educational class
Group Education: Participation in an insulin educational class"
464310|NCT00645528|P1|Participant Flow|Insulin Education Class Participants|"Subjects attended two group visits, two weeks apart, during which they received education regarding goals of therapy, insulin use, and hypoglycemia. Self-monitored blood glucose values were reviewed and insulin was initiated, if felt appropriate by the physician investigator and if accepted by the subject. The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit.The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment.
Additionally, at the second visit, proportion of blood glucose readings below 70 mg/dl were recorded. All patients were asked how many times in the two weeks they experienced symptoms/signs of low blood sugar, how many times they required sugar intake for the these symptoms, and how many times they required another person to assist them."
464311|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class
Group Education: Participation in an insulin educational class"
464312|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class
Group Education: Participation in an insulin educational class"
464313|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class
Group Education: Participation in an insulin educational class"
464314|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class
Group Education: Participation in an insulin educational class"
464315|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class
Group Education: Participation in an insulin educational class"
464316|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class
Group Education: Participation in an insulin educational class"
464317|NCT00645528|E1|Reported Event|Arm 1|"Participation in an insulin educational class
Group Education: Participation in an insulin educational class"
464318|NCT00645567|B1|Baseline|Wheelchair Transfer Interventions|Persons with SCI who evaluated wheelchair transfer interventions
464319|NCT00645567|P1|Participant Flow|Wheelchair Transfer Interventions|5 persons with SCI were recruited and provided informed consent. Four completed the protocol. One was dropped due to an unrelated injury to the subjects hand at his home.
464320|NCT00645567|O5|Outcome|Unassisted Manual Transfer|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
464321|NCT00645567|O4|Outcome|Ryno Lift|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
464322|NCT00645567|O3|Outcome|Easy Reach Lift|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
464324|NCT00645567|O1|Outcome|Glide n' Go|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study, but verifiable data is not available for any of the participants.
464325|NCT00645567|E1|Reported Event|Group 1|persons with SCI
464326|NCT00645593|B3|Baseline|Total|Total of all reporting groups
464327|NCT00645593|B2|Baseline|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
464328|NCT00645593|B1|Baseline|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
464329|NCT00645593|P2|Participant Flow|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
464330|NCT00645593|P1|Participant Flow|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
464331|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
464332|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
464333|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
464334|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
464335|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
464336|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
464337|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
464338|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
464339|NCT00645593|E2|Reported Event|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
464387|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464340|NCT00645593|E1|Reported Event|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
464341|NCT00645671|B3|Baseline|Total|Total of all reporting groups
464342|NCT00645671|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate ointment
464343|NCT00645671|B1|Baseline|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
464344|NCT00645671|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate ointment
464345|NCT00645671|P1|Participant Flow|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
464346|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
464347|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
464348|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
464349|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
464350|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
464351|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
464352|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
464354|NCT00645671|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate ointment
464355|NCT00645671|E1|Reported Event|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
464356|NCT00645762|B1|Baseline|Balloon Dilation|
464357|NCT00645762|P1|Participant Flow|FinESS Sisnus System Balloon Dilation|Transantral balloon dilation ofthe maxillary sinuses with the FinESS Sinus System.
464358|NCT00645762|O1|Outcome|FinESS Balloon Arm|Subjects completing 12 month post-procedure follow-up
464359|NCT00645762|O1|Outcome|FinESS Balloon Dilation|
464360|NCT00645762|O1|Outcome|Treatment Group (ALL)|FinESS Balloon Dilation
464361|NCT00645762|E1|Reported Event|Treatment Group (ALL)|
464362|NCT00645788|B5|Baseline|Total|Total of all reporting groups
464363|NCT00645788|B4|Baseline|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464364|NCT00645788|B3|Baseline|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464365|NCT00645788|B2|Baseline|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464366|NCT00645788|B1|Baseline|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464367|NCT00645788|P4|Participant Flow|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464368|NCT00645788|P3|Participant Flow|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464369|NCT00645788|P2|Participant Flow|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464370|NCT00645788|P1|Participant Flow|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464371|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464372|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464373|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464374|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464375|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464376|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464377|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464378|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464379|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464380|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464381|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464382|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464383|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464384|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464385|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464386|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464523|NCT00646646|E4|Reported Event|Propofol|"active drug
propofol : sedative"
464388|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464389|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464390|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464391|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464392|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464393|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464394|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464395|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464396|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464397|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464398|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464399|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464400|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464401|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464402|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464403|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464404|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464405|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464406|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464407|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464408|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464409|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464410|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464411|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464412|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464413|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464414|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464415|NCT00645788|E4|Reported Event|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
464416|NCT00645788|E3|Reported Event|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
464417|NCT00645788|E2|Reported Event|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464418|NCT00645788|E1|Reported Event|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
464419|NCT00645827|B3|Baseline|Total|Total of all reporting groups
464420|NCT00645827|B2|Baseline|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.
Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
464432|NCT00645853|P1|Participant Flow|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
464433|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
469011|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
464421|NCT00645827|B1|Baseline|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.
IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
464438|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
464439|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
464440|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
464474|NCT00646282|B2|Baseline|Control|Stable kidney transplant recipients do not receive any drug
464422|NCT00645827|P2|Participant Flow|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.
Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
464423|NCT00645827|P1|Participant Flow|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.
IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
464424|NCT00645827|O2|Outcome|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.
Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
464425|NCT00645827|O1|Outcome|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.
IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
464426|NCT00645827|E2|Reported Event|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.
Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
464427|NCT00645827|E1|Reported Event|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.
IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
464428|NCT00645853|B3|Baseline|Total|Total of all reporting groups
464429|NCT00645853|B2|Baseline|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
464430|NCT00645853|B1|Baseline|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
464431|NCT00645853|P2|Participant Flow|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
464519|NCT00646646|O4|Outcome|Placebo|placebo
464520|NCT00646646|O3|Outcome|Propofol|"active drug
propofol : sedative"
464434|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
464435|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
464436|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
464437|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
464441|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
464442|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
464443|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
464444|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
464445|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
464446|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
464447|NCT00645853|E2|Reported Event|VKA INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
464448|NCT00645853|E1|Reported Event|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
464449|NCT00645944|B3|Baseline|Total|Total of all reporting groups
464450|NCT00645944|B2|Baseline|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.
Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
464451|NCT00645944|B1|Baseline|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
464452|NCT00645944|P2|Participant Flow|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.
Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
464453|NCT00645944|P1|Participant Flow|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
464454|NCT00645944|O2|Outcome|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.
Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
464455|NCT00645944|O1|Outcome|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
464456|NCT00645944|E2|Reported Event|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.
Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
464457|NCT00645944|E1|Reported Event|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
464458|NCT00645970|B3|Baseline|Total|Total of all reporting groups
464459|NCT00645970|B2|Baseline|Registry|Participants recruited from the OEF/OIF/OND registry
464460|NCT00645970|B1|Baseline|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care
464461|NCT00645970|P2|Participant Flow|Registry|Participants recruited from the OEF/OIF/OND registry
464462|NCT00645970|P1|Participant Flow|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care (PSC)
464463|NCT00645970|O2|Outcome|Registry|Participants recruited from the OEF/OIF/OND registry
464464|NCT00645970|O1|Outcome|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care (PSC)
464465|NCT00645970|E2|Reported Event|Registry|Participants recruited from the OEF/OIF/OND registry
464466|NCT00645970|E1|Reported Event|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care
464467|NCT00646048|B1|Baseline|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
464468|NCT00646048|P1|Participant Flow|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
464521|NCT00646646|O2|Outcome|Midazolam|"Sedative
Midazolam : sedative"
464469|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
464470|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
464471|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
464472|NCT00646048|E1|Reported Event|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
464473|NCT00646282|B3|Baseline|Total|Total of all reporting groups
469044|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
464475|NCT00646282|B1|Baseline|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
464476|NCT00646282|P2|Participant Flow|Control|Stable kidney transplant recipients do not receive any drug.
464477|NCT00646282|P1|Participant Flow|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
464478|NCT00646282|O2|Outcome|Control|Stable kidney transplant recipients will not receive any drug
464479|NCT00646282|O1|Outcome|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
464480|NCT00646282|E2|Reported Event|Control|Stable kidney transplant recipients will not receive any drug
464481|NCT00646282|E1|Reported Event|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
464482|NCT00646399|B3|Baseline|Total|Total of all reporting groups
464483|NCT00646399|B2|Baseline|Placebo|
464484|NCT00646399|B1|Baseline|Pagibaximab|
464485|NCT00646399|P2|Participant Flow|Placebo|
464486|NCT00646399|P1|Participant Flow|Pagibaximab|
464487|NCT00646399|O2|Outcome|Placebo|
464488|NCT00646399|O1|Outcome|Pagibaximab|
464489|NCT00646399|E2|Reported Event|Placebo|
464490|NCT00646399|E1|Reported Event|Pagibaximab|
464491|NCT00646581|B3|Baseline|Total|Total of all reporting groups
464492|NCT00646581|B2|Baseline|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
464493|NCT00646581|B1|Baseline|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
464494|NCT00646581|P2|Participant Flow|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
464495|NCT00646581|P1|Participant Flow|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
464496|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
464497|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
464498|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
464499|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
464500|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
464501|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
464502|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
464503|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
464504|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
464505|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
464506|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
464507|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
464508|NCT00646581|E2|Reported Event|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
464509|NCT00646581|E1|Reported Event|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
464510|NCT00646646|B5|Baseline|Total|Total of all reporting groups
464511|NCT00646646|B4|Baseline|Propofol|"active drug
propofol : sedative"
464512|NCT00646646|B3|Baseline|Placebo|"placebo control
saline placebo : saline placebo"
464513|NCT00646646|B2|Baseline|Midazolam|"Sedative
Midazolam : sedative"
464514|NCT00646646|B1|Baseline|Dexmedetomidine|"sedative
dexmedetomidine : Sedative"
464515|NCT00646646|P4|Participant Flow|Propofol|Sedative Drug 3
464516|NCT00646646|P3|Participant Flow|Placebo|Placebo Control
464517|NCT00646646|P2|Participant Flow|Midazolam|Sedative Drug 2
464518|NCT00646646|P1|Participant Flow|Dexmedetomidine|Sedative Drug 1
464524|NCT00646646|E3|Reported Event|Placebo|"placebo control
saline placebo : saline placebo"
464525|NCT00646646|E2|Reported Event|Midazolam|"Sedative
Midazolam : sedative"
464526|NCT00646646|E1|Reported Event|Dexmedetomidine|"sedative
dexmedetomidine : Sedative"
464527|NCT00646763|B3|Baseline|Total|Total of all reporting groups
464528|NCT00646763|B2|Baseline|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
464529|NCT00646763|B1|Baseline|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
464530|NCT00646763|P2|Participant Flow|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
464531|NCT00646763|P1|Participant Flow|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
464532|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
464533|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
464534|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
464535|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
464536|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
464537|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
464538|NCT00646763|E2|Reported Event|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
464539|NCT00646763|E1|Reported Event|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
464540|NCT00646776|B3|Baseline|Total|Total of all reporting groups
464541|NCT00646776|B2|Baseline|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464542|NCT00646776|B1|Baseline|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464543|NCT00646776|P2|Participant Flow|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464544|NCT00646776|P1|Participant Flow|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464545|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464546|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464547|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464548|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464549|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464550|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464551|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464552|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464938|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464553|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464554|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464555|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464593|NCT00646958|B1|Baseline|Radezolid QD|450 mg by mouth (PO) once daily (QD)
464594|NCT00646958|P3|Participant Flow|Linezolid BID|600 mg by mouth (PO) BID
464595|NCT00646958|P2|Participant Flow|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
464556|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464557|NCT00646776|O3|Outcome|RIB 300 mg QD|AUCtot for RIB 300 mg QD was calculated as 2 × AUCtot for RIB 150 mg QD.
464558|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QAD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464559|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464560|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464561|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464562|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464563|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464564|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464565|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464566|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464567|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464568|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464569|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464570|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464717|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
464571|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464572|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464596|NCT00646958|P1|Participant Flow|Radezolid QD|450 mg by mouth (PO) once daily (QD)
464597|NCT00646958|O3|Outcome|Linezolid BID|600 mg by mouth (PO) BID
464598|NCT00646958|O2|Outcome|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
464599|NCT00646958|O1|Outcome|Radezolid QD|450 mg by mouth (PO) once daily (QD)
464573|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464574|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464575|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464576|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464577|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464578|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464579|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464580|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464581|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464582|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464583|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464584|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464585|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464586|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464587|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
464588|NCT00646776|E2|Reported Event|RIB 150mg|
464589|NCT00646776|E1|Reported Event|ATV/RTV 300/100mg+RIB 150mg|
464590|NCT00646958|B4|Baseline|Total|Total of all reporting groups
464591|NCT00646958|B3|Baseline|Linezolid BID|600 mg by mouth (PO) BID
464592|NCT00646958|B2|Baseline|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
464601|NCT00646958|O2|Outcome|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
464602|NCT00646958|O1|Outcome|Radezolid QD|450 mg by mouth (PO) once daily (QD)
464603|NCT00646958|E3|Reported Event|Linezolid BID|600 mg by mouth (PO) BID
464604|NCT00646958|E2|Reported Event|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
464605|NCT00646958|E1|Reported Event|Radezolid QD|450 mg by mouth (PO) once daily (QD)
464606|NCT00647270|B4|Baseline|Total|Total of all reporting groups
464607|NCT00647270|B3|Baseline|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
464608|NCT00647270|B2|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
464609|NCT00647270|B1|Baseline|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
464610|NCT00647270|P3|Participant Flow|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
464611|NCT00647270|P2|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
464612|NCT00647270|P1|Participant Flow|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
464613|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
464614|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
464615|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
464616|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
464617|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
464618|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
464619|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
464620|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
464621|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
464622|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
464623|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
464624|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
464625|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
464626|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
464627|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
464628|NCT00647270|E6|Reported Event|Adalimumab 80 mg Monthly - Period 2|Adalimumab 80 mg monthly for Period 1 and Period 2
464629|NCT00647270|E5|Reported Event|Adalimumab 40 mg Eow-Period 2|Adalimumab 40 mg eow for Period 1 and Period 2
464630|NCT00647270|E4|Reported Event|Placebo/Adalimumab 40 mg Eow-Period 2|Placebo 40 mg eow for Period 1 (weeks 1-12) Subjects switched to Adalimumab 40 mg eow for remaining 12 weeks for Period 2
464631|NCT00647270|E3|Reported Event|Adalimumab 80 mg Monthly-Period 1|Adalimumab 80 mg monthly for Period 1 and Period 2
464632|NCT00647270|E2|Reported Event|Adalimumab 40 mg Eow -Period 1|Adalimumab 40 mg eow for Period 1 and Period 2
464633|NCT00647270|E1|Reported Event|Placebo Every Other Week (Eow)-Period 1|Placebo eow for 12 weeks for Period 1 Adalimumab 40 mg eow for remaining 12 weeks for Period 2
464634|NCT00647400|B3|Baseline|Total|Total of all reporting groups
464635|NCT00647400|B2|Baseline|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
464636|NCT00647400|B1|Baseline|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
464637|NCT00647400|P2|Participant Flow|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
464675|NCT00638651|O2|Outcome|Laser Treatment With Placebo Cream (Group 2)|"The tattoo will be treated with laser and placebo topical cream
1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy"
464638|NCT00647400|P1|Participant Flow|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
464639|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
464640|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
464641|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
464726|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
464642|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
464643|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
464644|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
464645|NCT00647400|E2|Reported Event|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
464646|NCT00647400|E1|Reported Event|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
464647|NCT00647556|B3|Baseline|Total|Total of all reporting groups
464648|NCT00647556|B2|Baseline|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
464649|NCT00647556|B1|Baseline|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
464650|NCT00647556|P2|Participant Flow|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
464651|NCT00647556|P1|Participant Flow|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
464652|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
464653|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
464654|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
464655|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
464656|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
464657|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
464658|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
464659|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
464660|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
464661|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
464662|NCT00647556|E2|Reported Event|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
464663|NCT00647556|E1|Reported Event|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
464664|NCT00647699|B3|Baseline|Total|Total of all reporting groups
464665|NCT00647699|B2|Baseline|Control Group|riboflavin ophthalmic solution without UVA irradiation
464666|NCT00647699|B1|Baseline|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
464667|NCT00647699|P2|Participant Flow|Control Group|riboflavin ophthalmic solution without UVA irradiation
464668|NCT00647699|P1|Participant Flow|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
464669|NCT00647699|O2|Outcome|Control Group|riboflavin ophthalmic solution without UVA irradiation
464670|NCT00647699|O1|Outcome|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
464671|NCT00647699|E2|Reported Event|Control Group|riboflavin ophthalmic solution without UVA irradiation
464672|NCT00647699|E1|Reported Event|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
464673|NCT00638651|B1|Baseline|Laser Treatment With Imiquimod Cream or Placebo|One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
464674|NCT00638651|P1|Participant Flow|Laser Treatment With Imiquimod Cream or Placebo|Participants with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
464676|NCT00638651|O1|Outcome|Laser Treatment With Imiquimod (Group 1)|"The tattoo will be treated with laser and imiquimod 5% cream
1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy
Imiquimod, 5% cream: 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month"
464677|NCT00638651|E1|Reported Event|Laser Treatment With Imiquimod Cream or Placebo|One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
464678|NCT00638690|B3|Baseline|Total|Total of all reporting groups
464679|NCT00638690|B2|Baseline|Placebo|Placebo plus prednisone/prednisolone
464680|NCT00638690|B1|Baseline|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
464681|NCT00638690|P2|Participant Flow|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
464727|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
464682|NCT00638690|P1|Participant Flow|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
464683|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
464684|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
464685|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
464686|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
464687|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
464688|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
464689|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
464690|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
464691|NCT00638690|E3|Reported Event|Placebo to Abiraterone Acetate|Placebo plus prednisone/prednisolone crossed over to abiraterone acetate plus prednisone/prednisolone
464692|NCT00638690|E2|Reported Event|Placebo|Placebo plus prednisone/prednisolone
464693|NCT00638690|E1|Reported Event|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
464694|NCT00638716|B4|Baseline|Total|Total of all reporting groups
464695|NCT00638716|B3|Baseline|Placebo|"12 weekly doses of placebo
Placebo: Placebo"
464696|NCT00638716|B2|Baseline|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
464697|NCT00638716|B1|Baseline|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC"
464698|NCT00638716|P3|Participant Flow|Placebo|"12 weekly doses of placebo
Placebo: Placebo"
464699|NCT00638716|P2|Participant Flow|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
464700|NCT00638716|P1|Participant Flow|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC"
464701|NCT00638716|O3|Outcome|Placebo|"12 weekly doses of placebo
Placebo: Placebo"
464702|NCT00638716|O2|Outcome|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
464703|NCT00638716|O1|Outcome|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC"
464704|NCT00638716|O3|Outcome|Placebo|"12 weekly doses of placebo
Placebo: Placebo"
464705|NCT00638716|O2|Outcome|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
464706|NCT00638716|O1|Outcome|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC"
464707|NCT00638716|O3|Outcome|Placebo|"12 weekly doses of placebo
Placebo: Placebo"
464708|NCT00638716|O2|Outcome|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
464709|NCT00638716|O1|Outcome|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC"
464710|NCT00638716|E3|Reported Event|Placebo|"12 weekly doses of placebo
Placebo: Placebo"
464711|NCT00638716|E2|Reported Event|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
464712|NCT00638716|E1|Reported Event|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC"
464713|NCT00638820|B1|Baseline|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
464714|NCT00638820|P1|Participant Flow|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
464715|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
464716|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
464761|NCT00638963|P2|Participant Flow|Observational|No temozolomide treatment
464718|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
464719|NCT00638820|E1|Reported Event|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
464720|NCT00638846|B3|Baseline|Total|Total of all reporting groups
464721|NCT00638846|B2|Baseline|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
464722|NCT00638846|B1|Baseline|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
464723|NCT00638846|P2|Participant Flow|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
464724|NCT00638846|P1|Participant Flow|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
464725|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
464774|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
464728|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
464729|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
464730|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
464731|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
464732|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
464733|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
464734|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
464735|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
464736|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
464737|NCT00638846|E2|Reported Event|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
464738|NCT00638846|E1|Reported Event|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
464739|NCT00638885|B1|Baseline|Group 1|Vietnam veterans who were twins with and without posttraumatic stress disorder underwent neuropsychological testing and MRI imaging of hippocampal volume at baseline. There were no clinical interventions.
464740|NCT00638885|P1|Participant Flow|Group 1|Vietnam veterans who were twins with and without posttraumatic stress disorder underwent neuropsychological testing and MRI imaging of hippocampal volume at baseline. There were no clinical interventions.
464741|NCT00638885|O1|Outcome|Vietnam Veteran Twins|Vietnam veteran twins with and without PTSD.
464742|NCT00638885|E1|Reported Event|Vietnam Twins With and Without PTSD|
464743|NCT00638924|B1|Baseline|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
464744|NCT00638924|P1|Participant Flow|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
464745|NCT00638924|O1|Outcome|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
464746|NCT00638924|O1|Outcome|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
464747|NCT00638924|E1|Reported Event|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
464748|NCT00638937|B1|Baseline|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
saracatinib: Given PO
laboratory biomarker analysis: Correlative studies"
464749|NCT00638937|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
saracatinib: 175mg given PO daily
laboratory biomarker analysis: Correlative studies"
464750|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
saracatinib: Given PO"
464751|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
saracatinib: Given PO"
464752|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
saracatinib: Given PO"
464753|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
saracatinib: Given PO"
464754|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
saracatinib: Given PO"
464755|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
saracatinib: Given PO"
464756|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
saracatinib: Given PO
laboratory biomarker analysis: Correlative studies"
464757|NCT00638937|E1|Reported Event|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
saracatinib: Given PO
laboratory biomarker analysis: Correlative studies"
464758|NCT00638963|B3|Baseline|Total|Total of all reporting groups
464759|NCT00638963|B2|Baseline|Observational|No temozolomide treatment
464760|NCT00638963|B1|Baseline|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
469012|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
464762|NCT00638963|P1|Participant Flow|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464763|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464764|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464765|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464766|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464767|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464768|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
464769|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464770|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
464771|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464772|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
464773|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464775|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464776|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
464777|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464778|NCT00638963|E2|Reported Event|Observational|No temozolomide treatment
464779|NCT00638963|E1|Reported Event|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
464780|NCT00638989|B4|Baseline|Total|Total of all reporting groups
464781|NCT00638989|B3|Baseline|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464782|NCT00638989|B2|Baseline|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464783|NCT00638989|B1|Baseline|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464784|NCT00638989|P3|Participant Flow|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464785|NCT00638989|P2|Participant Flow|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464786|NCT00638989|P1|Participant Flow|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464787|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464788|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464789|NCT00638989|O2|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464790|NCT00638989|O1|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464791|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464792|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464793|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464794|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464795|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464796|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464797|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464798|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464799|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464800|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464801|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464802|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464803|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464804|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464805|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464806|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464807|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464808|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464809|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464810|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464811|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464812|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464813|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464814|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464815|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464816|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464817|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464818|NCT00638989|O2|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464819|NCT00638989|O1|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464820|NCT00638989|E3|Reported Event|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
464821|NCT00638989|E2|Reported Event|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
464822|NCT00638989|E1|Reported Event|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
464842|NCT00639158|P1|Participant Flow|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
464843|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
464844|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
464845|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
464823|NCT00639002|B1|Baseline|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
464824|NCT00639002|P1|Participant Flow|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
464825|NCT00639002|O1|Outcome|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
464826|NCT00639002|O1|Outcome|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
464827|NCT00639002|E2|Reported Event|Ruxolitinib + Dexamethasone|Following administration of ruxolitinib 25 mg bid alone, for those patients who had disease progression at any time, stable disease for 3 cycles, did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
464828|NCT00639002|E1|Reported Event|Ruxolitinib|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days until the following criteria were met: Disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent.
464829|NCT00639093|B3|Baseline|Total|Total of all reporting groups
464830|NCT00639093|B2|Baseline|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
464831|NCT00639093|B1|Baseline|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
464832|NCT00639093|P2|Participant Flow|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
464833|NCT00639093|P1|Participant Flow|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
464834|NCT00639093|O2|Outcome|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
464835|NCT00639093|O1|Outcome|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
469013|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
464836|NCT00639093|E2|Reported Event|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
464837|NCT00639093|E1|Reported Event|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
464838|NCT00639158|B3|Baseline|Total|Total of all reporting groups
464839|NCT00639158|B2|Baseline|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
464840|NCT00639158|B1|Baseline|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
464841|NCT00639158|P2|Participant Flow|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
464846|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
464847|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
464848|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
464849|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
464850|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
464851|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
464852|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
464853|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
464854|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
464855|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
464856|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
464857|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
464858|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
464859|NCT00639158|E2|Reported Event|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
464860|NCT00639158|E1|Reported Event|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
464861|NCT00639223|B3|Baseline|Total|Total of all reporting groups
464862|NCT00639223|B2|Baseline|Red Yeast Rice|
464863|NCT00639223|B1|Baseline|Pravastatin|
464864|NCT00639223|P2|Participant Flow|Red Yeast Rice|
464865|NCT00639223|P1|Participant Flow|Pravastatin|
464866|NCT00639223|O2|Outcome|Red Yeast Rice|
464867|NCT00639223|O1|Outcome|Pravastatin|
464868|NCT00639223|O2|Outcome|Red Yeast Rice|
464869|NCT00639223|O1|Outcome|Pravastatin|
464870|NCT00639223|E2|Reported Event|Red Yeast Rice|
464871|NCT00639223|E1|Reported Event|Pravastatin|
464872|NCT00639379|B1|Baseline|Total Completed Participants|
464873|NCT00639379|P2|Participant Flow|Alphafilcon A Toric / Senofilcon A Toric|alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
464874|NCT00639379|P1|Participant Flow|Senofilcon A Toric / Alphafilcon A Toric|senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.
464875|NCT00639379|O2|Outcome|Alphafilcon A Toric|
464876|NCT00639379|O1|Outcome|Senofilcon A Toric|
464877|NCT00639379|O2|Outcome|Alphafilcon A Toric|
464878|NCT00639379|O1|Outcome|Senofilcon A Toric|
464879|NCT00639379|O2|Outcome|Alphafilcon A Toric|
464880|NCT00639379|O1|Outcome|Senofilcon A Toric|
464881|NCT00639379|O2|Outcome|Alphafilcon A Toric|
464882|NCT00639379|O1|Outcome|Senofilcon A Toric|
464883|NCT00639379|O2|Outcome|Alphafilcon A Toric|
464884|NCT00639379|O1|Outcome|Senofilcon A Toric|
464885|NCT00639379|E2|Reported Event|Alphafilcon A Toric / Senofilcon A Toric|alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
464886|NCT00639379|E1|Reported Event|Senofilcon A Toric / Alphafilcon A Toric|senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.
464887|NCT00639418|B5|Baseline|Total|Total of all reporting groups
464888|NCT00639418|B4|Baseline|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
464889|NCT00639418|B3|Baseline|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
464890|NCT00639418|B2|Baseline|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
464891|NCT00639418|B1|Baseline|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
464892|NCT00639418|P4|Participant Flow|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
464893|NCT00639418|P3|Participant Flow|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
464894|NCT00639418|P2|Participant Flow|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
464895|NCT00639418|P1|Participant Flow|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
464896|NCT00639418|O4|Outcome|Staff Attitudes: Number of Doses|Number of sites that agreed or somewhat agreed that they strongly recommend that previously unvaccinated patients less than 9 years of age receive 2 doses of influenza vaccine
469014|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
464897|NCT00639418|O3|Outcome|Staff Attitudes: 5 to 18 Year Old Patients|Number of sites that agreed or somewhat agreed that they strongly recommend that patients 5 to 18 years of age without high-risk medical conditions be vaccinated against influenza each year
464898|NCT00639418|O2|Outcome|Staff Attitudes: 6 Months to 5 Year Old Patients|Number of sites that strongly recommend that patients 6 months to 5 years of age be vaccinated against influenza each year.
464899|NCT00639418|O1|Outcome|Staff Attitudes: High-risk Medical Conditions|Number of sites that agreed or somewhat agreed that they strongly recommend seasonal influenza vaccination to patients 5 to 18 years of age with high-risk medical conditions
464900|NCT00639418|O4|Outcome|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
464901|NCT00639418|O3|Outcome|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
464902|NCT00639418|O2|Outcome|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
464903|NCT00639418|O1|Outcome|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
464904|NCT00639418|O4|Outcome|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
464905|NCT00639418|O3|Outcome|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
464906|NCT00639418|O2|Outcome|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
464907|NCT00639418|O1|Outcome|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
464908|NCT00639418|E4|Reported Event|Children 9 to 18 Years|AEs were not collected in this observational study of physician vaccination practices.
464909|NCT00639418|E3|Reported Event|Children 5 to 8 Years|AEs were not collected in this observational study of physician vaccination practices.
464910|NCT00639418|E2|Reported Event|Children 24 to 59 Months|AEs were not collected in this observational study of physician vaccination practices.
464911|NCT00639418|E1|Reported Event|Children 6 to 23 Months|AEs were not collected in this observational study of physician vaccination practices.
464912|NCT00639457|B3|Baseline|Total|Total of all reporting groups
464913|NCT00639457|B2|Baseline|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464914|NCT00639457|B1|Baseline|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464915|NCT00639457|P2|Participant Flow|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464916|NCT00639457|P1|Participant Flow|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464917|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464918|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464919|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464920|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464921|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464922|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464923|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464924|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464925|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464926|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464927|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464928|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464929|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464930|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464931|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464932|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464933|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464934|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464935|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464936|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464937|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464939|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464940|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464941|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464942|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464943|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464944|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464945|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464946|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
469045|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
464947|NCT00639457|E2|Reported Event|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
464948|NCT00639457|E1|Reported Event|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
464949|NCT00639509|B1|Baseline|IMC-A12|Participants will receive IMC-A12 at a dose of 6mg/kg IV over 1 hour on Day 1 every week.
464950|NCT00639509|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
464951|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
464952|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
464953|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
464954|NCT00639509|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
464955|NCT00639678|B5|Baseline|Total|Total of all reporting groups
464956|NCT00639678|B4|Baseline|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464957|NCT00639678|B3|Baseline|Raxibacumab - Single-Dose|Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464958|NCT00639678|B2|Baseline|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
464959|NCT00639678|B1|Baseline|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
464960|NCT00639678|P4|Participant Flow|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464961|NCT00639678|P3|Participant Flow|Raxibacumab - Single-Dose|Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464962|NCT00639678|P2|Participant Flow|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
464963|NCT00639678|P1|Participant Flow|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
464964|NCT00639678|O1|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464965|NCT00639678|O1|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464966|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464967|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464968|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
464969|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
465041|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.
OSSIX-Plus: resorbable collagen membrane"
464970|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464971|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464972|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
464973|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
464974|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464975|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464976|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
464977|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
464978|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464979|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464980|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
464981|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
464982|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464983|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464984|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
464985|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
464986|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464987|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464988|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
464989|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
464990|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464991|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464992|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
464993|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
464994|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464995|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464996|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
464997|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
464998|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
464999|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
465000|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
465001|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
465002|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
465003|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
465004|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
465005|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
465006|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
465007|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
465008|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
465009|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
465010|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
465011|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
465012|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
465013|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
465014|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
465015|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
465016|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
465017|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
465018|NCT00639678|E4|Reported Event|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
465019|NCT00639678|E3|Reported Event|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
465020|NCT00639678|E2|Reported Event|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
465021|NCT00639678|E1|Reported Event|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
465042|NCT00639860|E1|Reported Event|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.
OSSIX-Plus: resorbable collagen membrane"
465043|NCT00640016|B5|Baseline|Total|Total of all reporting groups
465044|NCT00640016|B4|Baseline|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465022|NCT00639717|B1|Baseline|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
465023|NCT00639717|P1|Participant Flow|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
465053|NCT00640016|O3|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465024|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
465025|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
465026|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
465027|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
465028|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
465029|NCT00639717|E1|Reported Event|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:
Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.
GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
465030|NCT00639769|B1|Baseline|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
465031|NCT00639769|P1|Participant Flow|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
465032|NCT00639769|O1|Outcome|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
465033|NCT00639769|O1|Outcome|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
465034|NCT00639769|E1|Reported Event|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
465035|NCT00639860|B1|Baseline|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.
OSSIX-Plus: resorbable collagen membrane"
465036|NCT00639860|P1|Participant Flow|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.
OSSIX-Plus: resorbable collagen membrane"
465037|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.
OSSIX-Plus: resorbable collagen membrane"
465038|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.
OSSIX-Plus: resorbable collagen membrane"
465039|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.
OSSIX-Plus: resorbable collagen membrane"
465040|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.
OSSIX-Plus: resorbable collagen membrane"
466071|NCT00650858|P3|Participant Flow|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
465045|NCT00640016|B3|Baseline|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465046|NCT00640016|B2|Baseline|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465047|NCT00640016|B1|Baseline|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
465048|NCT00640016|P4|Participant Flow|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465049|NCT00640016|P3|Participant Flow|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465050|NCT00640016|P2|Participant Flow|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465051|NCT00640016|P1|Participant Flow|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
465052|NCT00640016|O4|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465054|NCT00640016|O2|Outcome|CAT-354 1 mg/kg|CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465055|NCT00640016|O1|Outcome|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
465056|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465057|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465058|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465059|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465060|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465061|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465062|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465063|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465064|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465065|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465066|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465067|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465068|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465069|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465070|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465071|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465072|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465073|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465074|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465075|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465076|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465077|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465078|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465079|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465080|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465081|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465082|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465083|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465084|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465085|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465086|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465087|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
469015|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
465088|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465089|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465090|NCT00640016|E4|Reported Event|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465091|NCT00640016|E3|Reported Event|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465092|NCT00640016|E2|Reported Event|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
465093|NCT00640016|E1|Reported Event|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56
465114|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465115|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465094|NCT00640042|B1|Baseline|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465095|NCT00640042|P1|Participant Flow|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465096|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465097|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465098|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465099|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465100|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465101|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465102|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465103|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465104|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465105|NCT00640042|E1|Reported Event|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
465106|NCT00640315|B3|Baseline|Total|Total of all reporting groups
465107|NCT00640315|B2|Baseline|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465108|NCT00640315|B1|Baseline|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465109|NCT00640315|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465110|NCT00640315|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465111|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465112|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465113|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465441|NCT00647998|E1|Reported Event|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
465116|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465117|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465118|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465119|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465120|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465121|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465122|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465123|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465124|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465125|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465126|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465127|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465128|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465129|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465130|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465131|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465132|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465133|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465134|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465135|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465136|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465137|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465138|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465139|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465140|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465141|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465142|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465143|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465144|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465145|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465146|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465147|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465148|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465149|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
469016|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
465150|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465151|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465152|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465153|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465154|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465155|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465156|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465157|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465158|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465159|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465160|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465161|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465162|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465163|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465164|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465165|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465166|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465167|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465168|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465169|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465170|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465171|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465172|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465173|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465174|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465175|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465176|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465177|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465178|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465179|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465180|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465181|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465182|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465183|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465184|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465185|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465186|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465187|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465188|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465189|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465190|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
466072|NCT00650858|P2|Participant Flow|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
465191|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465192|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465193|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465194|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465195|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465196|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465197|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465198|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465199|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465200|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465201|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465202|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465203|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465204|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465205|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465206|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465207|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465208|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465209|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465210|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465211|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465212|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465213|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465214|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465215|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465216|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465217|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465218|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465219|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465220|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465221|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465222|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465223|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465224|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465225|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465226|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465227|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465228|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465229|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465230|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465231|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
466073|NCT00650858|P1|Participant Flow|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
465232|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465233|NCT00640315|E2|Reported Event|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
465234|NCT00640315|E1|Reported Event|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
465235|NCT00640328|B7|Baseline|Total|Total of all reporting groups
465236|NCT00640328|B6|Baseline|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465251|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465237|NCT00640328|B5|Baseline|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465238|NCT00640328|B4|Baseline|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465239|NCT00640328|B3|Baseline|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465240|NCT00640328|B2|Baseline|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465241|NCT00640328|B1|Baseline|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465242|NCT00640328|P6|Participant Flow|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465243|NCT00640328|P5|Participant Flow|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465244|NCT00640328|P4|Participant Flow|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465245|NCT00640328|P3|Participant Flow|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465246|NCT00640328|P2|Participant Flow|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465247|NCT00640328|P1|Participant Flow|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465248|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465317|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465249|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465250|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465252|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465253|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465254|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465255|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465256|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465257|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465258|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465259|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465260|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465261|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465262|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465263|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465264|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465265|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465266|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465427|NCT00640341|E2|Reported Event|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
465428|NCT00640341|E1|Reported Event|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
465267|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465268|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465269|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465270|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465271|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465272|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465273|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465274|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465275|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465276|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465277|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465278|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465279|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465280|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465281|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465282|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465283|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465284|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465429|NCT00647998|B3|Baseline|Total|Total of all reporting groups
465430|NCT00647998|B2|Baseline|Standard Care|No darbepoetin
465431|NCT00647998|B1|Baseline|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
465285|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465286|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465287|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465288|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465289|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465290|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465291|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465292|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465293|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465294|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465295|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465296|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465297|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465298|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465299|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465318|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465432|NCT00647998|P2|Participant Flow|Standard Care|No darbepoetin
465300|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465320|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465442|NCT00648037|B1|Baseline|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
465301|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465302|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465303|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465304|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465305|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465306|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465307|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465308|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465309|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465310|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465311|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465312|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465313|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465314|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
465315|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465316|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
466074|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
465319|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465545|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465321|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465322|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465323|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
465324|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
465325|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
465326|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465327|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465328|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465329|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465330|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465331|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465332|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465433|NCT00647998|P1|Participant Flow|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
465434|NCT00647998|O2|Outcome|Standard Care|No darbepoetin
465333|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
466015|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
465334|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465335|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465336|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465337|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465338|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465339|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before consideAfter completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.ring progression to the 700 mg dose.
465340|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465341|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465342|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465343|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465435|NCT00647998|O1|Outcome|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
465436|NCT00647998|O2|Outcome|Standard Care|"No Darbepoetin
Standard care"
466066|NCT00650845|E1|Reported Event|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
465344|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
466016|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
465345|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465346|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465347|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465348|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465349|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465350|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465351|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465352|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465353|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465354|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465377|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465389|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465355|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465356|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465357|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465358|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465359|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465360|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465361|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465362|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465363|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465364|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465365|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465417|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
465418|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
465419|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
465366|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465367|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465368|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465369|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465370|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465371|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465372|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465373|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465374|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465375|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465376|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465420|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
465421|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
466067|NCT00650858|B4|Baseline|Total|Total of all reporting groups
465378|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465379|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465380|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465381|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465382|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465383|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465384|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465385|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465386|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465387|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465388|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465422|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
465423|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
466075|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
465390|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465391|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465392|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465393|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465394|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465395|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465396|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465397|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465398|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465399|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465424|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
465425|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
465426|NCT00640341|E3|Reported Event|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
465437|NCT00647998|O1|Outcome|Darbepoetin|"Patients received 1mg/kg IV Darbepoetin immediately prior to surgery
Darbepoetin alfa: Patients will receive one IV injection of Darbepoetin alfa at doses ranging from 1mcg/kg to 6.5 mcg/kg prior to surgery
Standard care"
465438|NCT00647998|O2|Outcome|Standard Care|No darbepoetin
465439|NCT00647998|O1|Outcome|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
465440|NCT00647998|E2|Reported Event|Standard Care|No darbepoetin
465400|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465401|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465402|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465403|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465404|NCT00640328|E6|Reported Event|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465405|NCT00640328|E5|Reported Event|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465406|NCT00640328|E4|Reported Event|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465407|NCT00640328|E3|Reported Event|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465408|NCT00640328|E2|Reported Event|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465409|NCT00640328|E1|Reported Event|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
465410|NCT00640341|B4|Baseline|Total|Total of all reporting groups
465411|NCT00640341|B3|Baseline|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
465412|NCT00640341|B2|Baseline|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
465413|NCT00640341|B1|Baseline|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
465414|NCT00640341|P3|Participant Flow|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
465415|NCT00640341|P2|Participant Flow|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
465416|NCT00640341|P1|Participant Flow|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
465443|NCT00648037|P1|Participant Flow|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
465444|NCT00648037|O1|Outcome|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
465445|NCT00648037|E1|Reported Event|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
465446|NCT00648115|B4|Baseline|Total|Total of all reporting groups
465447|NCT00648115|B3|Baseline|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists
comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
465448|NCT00648115|B2|Baseline|Self-Study|"Self-study of vocational materials
comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
465449|NCT00648115|B1|Baseline|Basic Vocational Services|Basic vocational services but no manualized vocational program
465450|NCT00648115|P3|Participant Flow|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists
comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
465451|NCT00648115|P2|Participant Flow|Self-Study|"Self-study of vocational materials
comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
465452|NCT00648115|P1|Participant Flow|Basic Vocational Services|Basic vocational services but no manualized vocational program
465453|NCT00648115|O3|Outcome|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists
comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
465454|NCT00648115|O2|Outcome|Self-Study|"Self-study of vocational materials
comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
465455|NCT00648115|O1|Outcome|Basic Vocational Services|Basic vocational services but no manualized vocational program
465456|NCT00648115|O3|Outcome|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists
comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
465457|NCT00648115|O2|Outcome|Self-Study|"Self-study of vocational materials
comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
465458|NCT00648115|O1|Outcome|Basic Vocational Services|Basic vocational services but no manualized vocational program
465459|NCT00648115|E3|Reported Event|Arm 3|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists
comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
465460|NCT00648115|E2|Reported Event|Arm 2|"Self-study of vocational materials
comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
465461|NCT00648115|E1|Reported Event|Arm 1|Basic vocational services but no manualized vocational program
465462|NCT00648167|B1|Baseline|KRX-0502|Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)
465463|NCT00648167|P1|Participant Flow|KRX-0502|Ferric Citrate
465464|NCT00648167|O1|Outcome|KRX-0502 (Ferric Citrate)|Patients starting dose of 4.5 grams per day (n=34) and those starting on 6.0 grams per day (n=21)- immediate roll over from previous phosphate binder(s)
465465|NCT00648167|E1|Reported Event|KRX-0502|"Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)
Intent-to-Treat (ITT)"
465466|NCT00650546|B1|Baseline|Open-labeled Prospective Case Series|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated
Exenatide: 5 mcg twice a day titrated to 10 mcg twice a day"
465467|NCT00650546|P1|Participant Flow|Exenatide Group|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated
Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day"
465468|NCT00650546|O1|Outcome|Individuals Who Recieved Treatment With Exenatide|change of NAS score in eight adult patients with known type 2 DM and biopsy proven NAFLD after treatment with exenatide
465469|NCT00650546|O1|Outcome|Treatment With Exenatide|eight adult patients with known type 2 DM and biopsy proven NAFLD
465470|NCT00650546|E1|Reported Event|Exenatide Group|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated
Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day"
465471|NCT00650585|B3|Baseline|Total|Total of all reporting groups
465472|NCT00650585|B2|Baseline|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
465473|NCT00650585|B1|Baseline|Control Group|School did not receive Project ALERT, a substance use prevention program
465474|NCT00650585|P2|Participant Flow|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
465475|NCT00650585|P1|Participant Flow|Control Group|School did not receive Project ALERT, a substance use prevention program
465476|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
465477|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
465478|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
465479|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
465480|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
465481|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
465482|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
465483|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
465484|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
465485|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
465486|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
465487|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
465488|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
465489|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
465490|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
465491|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
465492|NCT00650585|E2|Reported Event|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
465493|NCT00650585|E1|Reported Event|Control Group|School did not receive Project ALERT, a substance use prevention program
465494|NCT00650767|B5|Baseline|Total|Total of all reporting groups
465495|NCT00650767|B4|Baseline|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465496|NCT00650767|B3|Baseline|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465497|NCT00650767|B2|Baseline|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465498|NCT00650767|B1|Baseline|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465499|NCT00650767|P4|Participant Flow|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465500|NCT00650767|P3|Participant Flow|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
466065|NCT00650845|E2|Reported Event|Non-enhanced MRI|non-enhanced MRI: non injected MRI
465501|NCT00650767|P2|Participant Flow|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465502|NCT00650767|P1|Participant Flow|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465503|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465504|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465505|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465506|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465507|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465508|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465509|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465510|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465511|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465512|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465513|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465514|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465515|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465516|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465517|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465518|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465519|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465520|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465521|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465522|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465523|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465524|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465525|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465526|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465527|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465528|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465529|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465530|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465531|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465532|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465533|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465534|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465535|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465536|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465537|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465538|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465539|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465540|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465541|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465542|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465543|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465544|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465546|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465547|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465548|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465549|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465550|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465551|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465552|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465553|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465554|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465555|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465556|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465557|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465558|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465559|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465560|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465561|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465562|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465563|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465564|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465565|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465566|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465567|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465568|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465569|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465570|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465571|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465572|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465573|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465574|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465575|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465576|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465577|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465578|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465579|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465580|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465581|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465582|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465583|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465584|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465585|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465586|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465587|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465588|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465589|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465590|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465591|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465592|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465593|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465594|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465595|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465596|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465597|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465598|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465599|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465600|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465601|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465602|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465603|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465604|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465605|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465606|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465607|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465608|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465609|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465610|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465611|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465612|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465613|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465614|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465615|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465616|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465617|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
466076|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
465618|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465619|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465620|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465621|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465622|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
469046|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
465623|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465624|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465625|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465626|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465627|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465628|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465629|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465630|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465631|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465632|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465633|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465634|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465635|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465636|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465637|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465638|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465639|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465640|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465641|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465642|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465643|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465644|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465645|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465646|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465647|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465648|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465649|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465650|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465651|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465652|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465653|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465654|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465655|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465656|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465657|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465658|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465659|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465660|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465661|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
469047|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
465662|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465663|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465664|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465665|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465666|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465667|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465668|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465669|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465670|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465671|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465672|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465673|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465674|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465675|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465676|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465677|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465678|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465679|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465680|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465681|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465682|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465683|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465684|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465685|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465686|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465687|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465688|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465689|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465690|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465691|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465692|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465693|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465694|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465695|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465696|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465697|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465698|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465699|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465700|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465701|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465702|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465703|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465704|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465705|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465706|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465707|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465708|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465709|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465710|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465711|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465712|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465713|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465714|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465715|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465716|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465717|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465718|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465719|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465720|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465721|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465722|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465723|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465724|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465725|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465726|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465727|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465728|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465729|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465730|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465731|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465732|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465733|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465734|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465735|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465736|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465737|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465738|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465739|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465740|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465741|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465742|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465743|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465744|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465745|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465746|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465747|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465748|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465749|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465750|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465751|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465752|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465753|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465754|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465755|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465756|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465757|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465758|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465759|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465760|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465761|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465762|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465763|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465764|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465765|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465766|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465767|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465768|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465769|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465770|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465771|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465772|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465773|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
466077|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
465774|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465775|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465776|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465777|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465817|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465778|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465779|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465780|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465781|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465782|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465783|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465784|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465785|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465786|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465787|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465788|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465789|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465790|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465791|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465792|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465793|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465794|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465795|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465796|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465797|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465798|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465799|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465800|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465801|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465802|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465803|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465804|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465805|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465806|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465807|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465808|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465809|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465810|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465811|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465812|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465813|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465814|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465815|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465816|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465818|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465819|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465820|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465821|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465822|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465823|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465824|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465825|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465826|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465827|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465828|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465829|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465830|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465831|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465832|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465833|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465834|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465835|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465836|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465837|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465838|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465839|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465840|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465841|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465842|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465843|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465844|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465845|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465846|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465847|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465848|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465849|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465850|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465851|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465852|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465853|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465854|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465855|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465856|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465857|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465858|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465859|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465860|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465861|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465862|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465863|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465864|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465865|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465866|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465867|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465868|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465869|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465870|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465871|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465872|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465873|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465874|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465875|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465876|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465877|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465878|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465879|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465880|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465881|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465882|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465883|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465884|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465885|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465886|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465887|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465888|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465889|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465890|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465891|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465892|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465893|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465894|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465895|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465896|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465897|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465898|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465899|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465900|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465901|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465902|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465903|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465904|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465905|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465906|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465907|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465908|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465909|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465910|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465911|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465912|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465913|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465914|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465915|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465916|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465917|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465918|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465919|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465920|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465921|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465922|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465923|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465924|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465925|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465926|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465927|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465928|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465929|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
466078|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
465930|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465931|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465932|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465933|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465973|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465934|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465935|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465936|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465937|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465938|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465939|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465940|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465941|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465942|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465943|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465944|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465945|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465946|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465947|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465948|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465949|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465950|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465951|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465952|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465953|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465954|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465955|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465956|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465957|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465958|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465959|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465960|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465961|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465962|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465963|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465964|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465965|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465966|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465967|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465968|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465969|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465970|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465971|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465972|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465974|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465975|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465976|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465977|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465978|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465979|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465980|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465981|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465982|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465983|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465984|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465985|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465986|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465987|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465988|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465989|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465990|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465991|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465992|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465993|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465994|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465995|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465996|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465997|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
465998|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
465999|NCT00650767|E4|Reported Event|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
466000|NCT00650767|E3|Reported Event|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
466001|NCT00650767|E2|Reported Event|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
466002|NCT00650767|E1|Reported Event|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
466003|NCT00650806|B5|Baseline|Total|Total of all reporting groups
466004|NCT00650806|B4|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466005|NCT00650806|B3|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466006|NCT00650806|B2|Baseline|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466007|NCT00650806|B1|Baseline|Placebo|Each patient received matching placebo once daily for 12 weeks.
466008|NCT00650806|P4|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canaliflozin (JNJ-28431754) once daily for 12 weeks.
466068|NCT00650858|B3|Baseline|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
466009|NCT00650806|P3|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466010|NCT00650806|P2|Participant Flow|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466011|NCT00650806|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 12 weeks.
466012|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466013|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466014|NCT00650806|O2|Outcome|Canaglifozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466017|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466018|NCT00650806|O2|Outcome|Canaglifozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466019|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
466020|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466021|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466022|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466023|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
466024|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466025|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466026|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466027|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
466028|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466029|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466030|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466031|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
466032|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466033|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466034|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466035|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
466036|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466037|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466038|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466039|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
466040|NCT00650806|O4|Outcome|Canaglifloziin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466041|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466042|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466043|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
466044|NCT00650806|E4|Reported Event|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466045|NCT00650806|E3|Reported Event|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466046|NCT00650806|E2|Reported Event|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
466047|NCT00650806|E1|Reported Event|Placebo|Each patient received matching placebo once daily for 12 weeks.
466048|NCT00650845|B3|Baseline|Total|Total of all reporting groups
466049|NCT00650845|B2|Baseline|Non-enhanced MRI|non-enhanced MRI: non injected MRI
466050|NCT00650845|B1|Baseline|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
466051|NCT00650845|P2|Participant Flow|Non-enhanced MRI|non-enhanced MRI: non injected MRI
466052|NCT00650845|P1|Participant Flow|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
466053|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
466054|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
466055|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
466056|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
466057|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
466058|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
466059|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
466060|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
466061|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
466062|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
466063|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
466064|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
466083|NCT00650858|E3|Reported Event|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
466084|NCT00650858|E2|Reported Event|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
466085|NCT00650858|E1|Reported Event|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
466086|NCT00651040|B3|Baseline|Total|Total of all reporting groups
466087|NCT00651040|B2|Baseline|2Prednison MTX|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
466234|NCT00652028|P2|Participant Flow|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
466088|NCT00651040|B1|Baseline|1Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone
Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
466089|NCT00651040|P2|Participant Flow|2Prednison MTX|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
466090|NCT00651040|P1|Participant Flow|1Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone
Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
466091|NCT00651040|O2|Outcome|Prednison Methotrexate 2|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
466092|NCT00651040|O1|Outcome|Prednison1|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone
Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
466093|NCT00651040|E2|Reported Event|2 Prednison Methotrexate|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
466094|NCT00651040|E1|Reported Event|1 Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone
Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
466095|NCT00651118|B5|Baseline|Total|Total of all reporting groups
466096|NCT00651118|B4|Baseline|Placebo|placebo nasal spray
466097|NCT00651118|B3|Baseline|Azelastine HCl|azelastine HCl nasal spray nasal spray
466098|NCT00651118|B2|Baseline|Fluticasone Propionate|fluticasone propionate nasal spray
466099|NCT00651118|B1|Baseline|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
466100|NCT00651118|P4|Participant Flow|Placebo|placebo nasal spray
466101|NCT00651118|P3|Participant Flow|Azelastine HCl|azelastine HCl nasal spray nasal spray
466102|NCT00651118|P2|Participant Flow|Fluticasone Propionate|fluticasone propionate nasal spray
466103|NCT00651118|P1|Participant Flow|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
466104|NCT00651118|O4|Outcome|Placebo|placebo nasal spray
466105|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray nasal spray
466106|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
466107|NCT00651118|O1|Outcome|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
466108|NCT00651118|O4|Outcome|Placebo|Placebo nasal spray
466109|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray
466110|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
466111|NCT00651118|O1|Outcome|MP29-02|fluticasone propionate 50 mcg / azelastine HCl 137 mcg nasal spray
466112|NCT00651118|O4|Outcome|Placebo|placebo nasal spray
466113|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray nasal spray
466114|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
466115|NCT00651118|O1|Outcome|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
466116|NCT00651118|E4|Reported Event|Placebo|placebo nasal spray
466117|NCT00651118|E3|Reported Event|Azelastine HCl|azelastine HCl nasal spray nasal spray
466118|NCT00651118|E2|Reported Event|Fluticasone Propionate|fluticasone propionate nasal spray
466119|NCT00651118|E1|Reported Event|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
466120|NCT00651157|B1|Baseline|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV administered at a dose of 3 x 10^10 TCID50/day in 250 mL 0.9% sodium chloride infused intravenously over 60 minutes daily on days 1-5 of each 28-day cycle. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
466121|NCT00651157|P1|Participant Flow|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
466122|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
466123|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
466124|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
466235|NCT00652028|P1|Participant Flow|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466125|NCT00651157|E1|Reported Event|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
466126|NCT00651183|B3|Baseline|Total|Total of all reporting groups
466127|NCT00651183|B2|Baseline|Advanced PD|Advanced Parkinson's Disease (PD) patients
466128|NCT00651183|B1|Baseline|Early PD|Early Parkinson's Disease (PD) patients
466129|NCT00651183|P2|Participant Flow|Advanced PD|Advanced Parkinson's Disease (PD) patients
466130|NCT00651183|P1|Participant Flow|Early (PD)|Early Parkinson's Disease (PD) patients
466131|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
466132|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
466133|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
466134|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
466135|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
466136|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
466137|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
466138|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
466139|NCT00651183|E2|Reported Event|Advanced PD|Advanced Parkinson's Disease (PD) patients
466140|NCT00651183|E1|Reported Event|Early PD|Early Parkinson's Disease (PD) patients
466141|NCT00651261|B3|Baseline|Total|Total of all reporting groups
466142|NCT00651261|B2|Baseline|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
466143|NCT00651261|B1|Baseline|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
466144|NCT00651261|P2|Participant Flow|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
466145|NCT00651261|P1|Participant Flow|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
466146|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
466147|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
466148|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
466149|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
466172|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
466150|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
466236|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
466661|NCT00643682|B2|Baseline|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
466151|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
466152|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
466153|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
466154|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
466155|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
466156|NCT00651261|E2|Reported Event|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
466157|NCT00651261|E1|Reported Event|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
466158|NCT00651313|B3|Baseline|Total|Total of all reporting groups
466159|NCT00651313|B2|Baseline|Placebo|Placebo vaginal gel
466160|NCT00651313|B1|Baseline|Active|Lidocaine 10% (150mg) vaginal gel
466161|NCT00651313|P2|Participant Flow|Placebo|Placebo vaginal gel
466162|NCT00651313|P1|Participant Flow|Active|Lidocaine 10% (150mg) vaginal gel
466163|NCT00651313|O2|Outcome|Placebo Gel|Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel
466164|NCT00651313|O1|Outcome|Lidocaine 10%|Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel
466165|NCT00651313|E2|Reported Event|Placebo|Placebo vaginal gel
466166|NCT00651313|E1|Reported Event|Active|Lidocaine 10% (150mg) vaginal gel
466167|NCT00651482|B1|Baseline|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
Everolimus
Bevacizumab"
466168|NCT00651482|P1|Participant Flow|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
Everolimus
Bevacizumab"
466169|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
466170|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
466171|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
466173|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
467174|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
466174|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
466175|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
466176|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
Everolimus
Bevacizumab"
466177|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
466178|NCT00651482|E1|Reported Event|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
466179|NCT00651625|B3|Baseline|Total|Total of all reporting groups
466180|NCT00651625|B2|Baseline|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466181|NCT00651625|B1|Baseline|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466182|NCT00651625|P2|Participant Flow|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466183|NCT00651625|P1|Participant Flow|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466184|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466185|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466230|NCT00652028|B2|Baseline|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
466237|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466238|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
469048|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
466186|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466187|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466188|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466189|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466190|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466191|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466192|NCT00651625|E2|Reported Event|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466193|NCT00651625|E1|Reported Event|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
466194|NCT00651755|B1|Baseline|Entire Study Population|Participants randomized to Aprepitant or control (Standard of Care) in Cycle 1 crossover for different treatment in Cycle 2.
466195|NCT00651755|P2|Participant Flow|First No Aprepritant Cycle 1, Then Aprepitant Cycle 2|First No Aprepitant in Cycle 1, then Aprepitant 125 mg oral (PO) Day 1 of Cycle 2 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above].
466231|NCT00652028|B1|Baseline|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466232|NCT00652028|P4|Participant Flow|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
466233|NCT00652028|P3|Participant Flow|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466196|NCT00651755|P1|Participant Flow|First Aprepitant Cycle 1 Then No Aprepitant Cycle 2|"First Aprepitant with CHOP or R-CHOP (CHOP plus Rituximab 375 mg/m^2 intravenous Day 1) then No Aprepitant in Cycle 2.
Aprepitant 125 mg oral (PO) Day 1 of Cycle 1 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above]."
466197|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
466198|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
466199|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
466200|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
466201|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
466202|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
466203|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
466204|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
466205|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
466206|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
466207|NCT00651755|O2|Outcome|Control Group|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
466208|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
466209|NCT00651755|E2|Reported Event|Control|Standard of Care
466210|NCT00651755|E1|Reported Event|Aprepitant|Aprepitant 125 mg oral (PO) Day 1 (Cycle 1 or Cycle 2) to include treated study population.
466211|NCT00651820|B1|Baseline|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
466212|NCT00651820|P1|Participant Flow|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
466213|NCT00651820|O2|Outcome|Vehicle Rate of Wound Closure|Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
466214|NCT00651820|O1|Outcome|Collagenase Santyl Rate of Wound Closure|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
466215|NCT00651820|O2|Outcome|Vehicle Rate to Complete Wound Healing|Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
466216|NCT00651820|O1|Outcome|Collagenase Santyl Rate of Wound Closure|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
466217|NCT00651820|E1|Reported Event|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
466218|NCT00651924|B3|Baseline|Total|Total of all reporting groups
466219|NCT00651924|B2|Baseline|Phase 2|Pilot IVR-based Cognitive-behavior therapy: Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts
466220|NCT00651924|B1|Baseline|Phase 1|Review the materials and provide feedback regarding how understandable, engaging, and informative the materials are.
466221|NCT00651924|P2|Participant Flow|Phase 2|Undergo IVR-based Cognitive Behavioral Therapy treatment using the new materials.
466222|NCT00651924|P1|Participant Flow|Phase 1|Review of materials and provide feedback regarding how understandable, engaging, and informative the materials are. Revisions will be made based on this feedback.
466223|NCT00651924|O2|Outcome|Phase 2|Pilot IVR-based CBT treatment
466224|NCT00651924|O1|Outcome|Phase 1|Qualitative interviews
466225|NCT00651924|E2|Reported Event|Phase 2|Pilot the newly developed materials during a 10-week course of cognitive behavioral therapy for chronic pain
466226|NCT00651924|E1|Reported Event|Phase 1|Review of newly created materials and provide feedback regarding how understandable, engaging, and informative the materials are.
466227|NCT00652028|B5|Baseline|Total|Total of all reporting groups
466228|NCT00652028|B4|Baseline|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
466229|NCT00652028|B3|Baseline|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466239|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466240|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
466241|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466242|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
466243|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466244|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
466245|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466246|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
466247|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466248|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
466249|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466250|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
466251|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466252|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
466253|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466254|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
466255|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466256|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
466257|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466258|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
466259|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466260|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
466261|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466262|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
466263|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466264|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
466265|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466266|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
466267|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466268|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
466269|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466270|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
466271|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466272|NCT00652028|E4|Reported Event|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
467160|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
466273|NCT00652028|E3|Reported Event|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
466274|NCT00652028|E2|Reported Event|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
466275|NCT00652028|E1|Reported Event|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
466276|NCT00652093|B7|Baseline|Total|Total of all reporting groups
466399|NCT00652327|B1|Baseline|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
469049|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
466277|NCT00652093|B6|Baseline|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466278|NCT00652093|B5|Baseline|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466279|NCT00652093|B4|Baseline|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466280|NCT00652093|B3|Baseline|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466281|NCT00652093|B2|Baseline|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466282|NCT00652093|B1|Baseline|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466283|NCT00652093|P6|Participant Flow|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466284|NCT00652093|P5|Participant Flow|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466285|NCT00652093|P4|Participant Flow|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466286|NCT00652093|P3|Participant Flow|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466287|NCT00652093|P2|Participant Flow|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466288|NCT00652093|P1|Participant Flow|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466289|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466290|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466291|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466292|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466293|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466294|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466295|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466296|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466400|NCT00652327|P2|Participant Flow|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
469050|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
466297|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466298|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466299|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466300|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466301|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466302|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466303|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466304|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466305|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466306|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466307|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466308|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466309|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466310|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466311|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466312|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466313|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466314|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466315|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466316|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466317|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466318|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466319|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466320|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466321|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466322|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466323|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466324|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466325|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466326|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466327|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466328|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466329|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466330|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466331|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466332|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466333|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466334|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466335|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466336|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466337|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466338|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466339|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466340|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466341|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466342|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466343|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466344|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466345|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466346|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466347|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466348|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466349|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466350|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466351|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466352|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466353|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466354|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466355|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466356|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466357|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466358|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466359|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466360|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466361|NCT00652093|E6|Reported Event|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466362|NCT00652093|E5|Reported Event|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466363|NCT00652093|E4|Reported Event|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
466364|NCT00652093|E3|Reported Event|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466365|NCT00652093|E2|Reported Event|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
466366|NCT00652093|E1|Reported Event|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
466367|NCT00652145|B3|Baseline|Total|Total of all reporting groups
466368|NCT00652145|B2|Baseline|Maintain Mesalamine Dose|Participants were randomized to maintain their baseline mesalamine dose
466369|NCT00652145|B1|Baseline|Increase Mesalamine Dose|Participants were randomized to increase dose of mesalamine by 2.4 gm per day over their baseline dose
466370|NCT00652145|P2|Participant Flow|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
466371|NCT00652145|P1|Participant Flow|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
466372|NCT00652145|O2|Outcome|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
466373|NCT00652145|O1|Outcome|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
466374|NCT00652145|O2|Outcome|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
466375|NCT00652145|O1|Outcome|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
466376|NCT00652145|O2|Outcome|Maintain Mesalmine Dose|Maintain current mesalamine dose at 2.4 g/day
466377|NCT00652145|O1|Outcome|Increase Mesalamine Dose by 2.4g/Day|"Increase dose of mesalamine by 2.4 gm per day
mesalamine: Increase dose by 2.4gm per day over baseline dose"
466378|NCT00652145|E2|Reported Event|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
466379|NCT00652145|E1|Reported Event|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
466380|NCT00652314|B3|Baseline|Total|Total of all reporting groups
466381|NCT00652314|B2|Baseline|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466382|NCT00652314|B1|Baseline|1 - Thrombi-gel Treatment|"Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466383|NCT00652314|P2|Participant Flow|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466384|NCT00652314|P1|Participant Flow|1 - Thrombi-gel Treatment|"Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466385|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466386|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466387|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466388|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466389|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466390|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466391|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466392|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466393|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466394|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466395|NCT00652314|E2|Reported Event|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466396|NCT00652314|E1|Reported Event|1 - Thrombi-gel Treatment|"Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery"
466397|NCT00652327|B3|Baseline|Total|Total of all reporting groups
466398|NCT00652327|B2|Baseline|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
466401|NCT00652327|P1|Participant Flow|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
466402|NCT00652327|O2|Outcome|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
466403|NCT00652327|O1|Outcome|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
466404|NCT00652327|E2|Reported Event|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
466405|NCT00652327|E1|Reported Event|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
466406|NCT00652340|B3|Baseline|Total|Total of all reporting groups
466407|NCT00652340|B2|Baseline|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
466408|NCT00652340|B1|Baseline|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
466409|NCT00652340|P2|Participant Flow|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
466410|NCT00652340|P1|Participant Flow|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
466411|NCT00652340|O2|Outcome|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
466412|NCT00652340|O1|Outcome|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
466413|NCT00652340|O2|Outcome|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
466414|NCT00652340|O1|Outcome|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
466415|NCT00652340|E2|Reported Event|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
466416|NCT00652340|E1|Reported Event|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
466417|NCT00652366|B6|Baseline|Total|Total of all reporting groups
466418|NCT00652366|B5|Baseline|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
466419|NCT00652366|B4|Baseline|G+E: No Rash Non-Eligible|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466420|NCT00652366|B3|Baseline|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466421|NCT00652366|B2|Baseline|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466422|NCT00652366|B1|Baseline|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466423|NCT00652366|P5|Participant Flow|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
466462|NCT00652626|B5|Baseline|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466463|NCT00652626|B4|Baseline|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
467631|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
466424|NCT00652366|P4|Participant Flow|G+E: No Rash Non-Eligibl|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466425|NCT00652366|P3|Participant Flow|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 milligrams per day (mg/day), PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade ≥ 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466426|NCT00652366|P2|Participant Flow|G+E Standard Dose: Rash Grade Less Than (<) 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466427|NCT00652366|P1|Participant Flow|Gemcitabine (G) Plus (+) Erlotinib (E): Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466428|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466429|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466430|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466431|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466432|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466464|NCT00652626|B3|Baseline|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466433|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466471|NCT00652626|P3|Participant Flow|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466434|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466435|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466436|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466437|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466438|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466439|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466440|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466441|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466465|NCT00652626|B2|Baseline|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466466|NCT00652626|B1|Baseline|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
467161|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
466472|NCT00652626|P2|Participant Flow|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466473|NCT00652626|P1|Participant Flow|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
466474|NCT00652626|O7|Outcome|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
466442|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466443|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466444|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466445|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466446|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466447|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466448|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466449|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466467|NCT00652626|P7|Participant Flow|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
466468|NCT00652626|P6|Participant Flow|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
466469|NCT00652626|P5|Participant Flow|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
467162|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
466450|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466451|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months
466452|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466453|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466454|NCT00652366|E5|Reported Event|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
466455|NCT00652366|E4|Reported Event|G+E: No Rash Non-Eligible|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466456|NCT00652366|E3|Reported Event|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466457|NCT00652366|E2|Reported Event|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
466458|NCT00652366|E1|Reported Event|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
466459|NCT00652626|B8|Baseline|Total|Total of all reporting groups
466460|NCT00652626|B7|Baseline|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
466461|NCT00652626|B6|Baseline|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
466470|NCT00652626|P4|Participant Flow|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
466475|NCT00652626|O6|Outcome|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
466476|NCT00652626|O5|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466477|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
466478|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466479|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466480|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
466481|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466482|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466483|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466484|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466485|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466486|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466487|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466488|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466489|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466490|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466491|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466492|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466493|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466494|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466495|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466496|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466497|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
466498|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466499|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466500|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
466501|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
466502|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466503|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466504|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
466505|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
466506|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466507|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466508|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
466509|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
466510|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466511|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466512|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
466513|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
466514|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466515|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466516|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
466517|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
466518|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466519|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466520|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
466521|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
466522|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466523|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466524|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
466525|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
466526|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466527|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466528|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
466529|NCT00652626|E7|Reported Event|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
466530|NCT00652626|E6|Reported Event|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
466531|NCT00652626|E5|Reported Event|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466532|NCT00652626|E4|Reported Event|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
466533|NCT00652626|E3|Reported Event|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
466534|NCT00652626|E2|Reported Event|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
466535|NCT00652626|E1|Reported Event|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
466536|NCT00643201|B3|Baseline|Total|Total of all reporting groups
466537|NCT00643201|B2|Baseline|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2.
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466538|NCT00643201|B1|Baseline|Apixaban|"apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.
Placebo for enoxaparin: solution, subcutaneous, 1milligram per kilogram (mg/kg) every 12 hours until sham International normalized ratio (INR) greater than, equal to ( ≥) 2.
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466539|NCT00643201|P2|Participant Flow|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2.
Warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466540|NCT00643201|P1|Participant Flow|Apixaban|"apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.
Placebo for enoxaparin: solution, subcutaneous, 1milligram per kilogram (mg/kg) every 12 hours until sham international normalized ratio (INR) greater than, equal to ( ≥) 2.
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466541|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466542|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466543|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466544|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466545|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466546|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466547|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466548|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466549|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466550|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466551|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466552|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466553|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466554|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466555|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466556|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466557|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466558|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466559|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466560|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466561|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466562|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466563|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
467163|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
466564|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466565|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466566|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466567|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466568|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466569|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466570|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466571|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466572|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466573|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466574|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2 Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466575|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466576|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2 Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466577|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466578|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466579|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466580|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466581|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466582|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466583|NCT00643201|E2|Reported Event|Enoxaparin/Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2
warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
466584|NCT00643201|E1|Reported Event|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2
Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
466585|NCT00643448|B4|Baseline|Total|Total of all reporting groups
466586|NCT00643448|B3|Baseline|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
466587|NCT00643448|B2|Baseline|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466588|NCT00643448|B1|Baseline|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466589|NCT00643448|P3|Participant Flow|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
466590|NCT00643448|P2|Participant Flow|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466591|NCT00643448|P1|Participant Flow|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466592|NCT00643448|O3|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
466593|NCT00643448|O2|Outcome|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466594|NCT00643448|O1|Outcome|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466595|NCT00643448|O3|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
466596|NCT00643448|O2|Outcome|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466597|NCT00643448|O1|Outcome|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466598|NCT00643448|O2|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
466599|NCT00643448|O1|Outcome|AZD1305 Group A and AZD1305 Group B|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466600|NCT00643448|O2|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
466601|NCT00643448|O1|Outcome|AZD1305 Group A and AZD1305 Group B|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466602|NCT00643448|E3|Reported Event|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
466603|NCT00643448|E2|Reported Event|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466604|NCT00643448|E1|Reported Event|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
466605|NCT00643487|B1|Baseline|All Participants|No new arms or groups were associated with this observational study
466606|NCT00643487|P1|Participant Flow|All Participants|In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
466607|NCT00643487|O1|Outcome|All Participants|In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
466608|NCT00643487|E1|Reported Event|All Participants|observation of the behavior of the infrapatellar plica: Local anesthesia using bupivicaine will be initiated. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, will be injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization will be verified and the knee taken through a full range of passive and active exercises. Active quadriceps contraction in the subject will be performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP will be videotaped and recorded on lateral fluoroscopy.
466609|NCT00643565|B3|Baseline|Total|Total of all reporting groups
466610|NCT00643565|B2|Baseline|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466611|NCT00643565|B1|Baseline|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
467175|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
466612|NCT00643565|P2|Participant Flow|Bevacizumab + Chemotherapy|Participants received continuous intravenous (IV) infusion of bevacizumab (7.5 milligrams per kilogram [mg/kg] every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466613|NCT00643565|P1|Participant Flow|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy i.e. with ifosfamide [I], vincristine [V], actinomycin D [A] and doxorubicin [Do] followed by 5 cycles of IVA-containing chemotherapy [i.e. without doxorubicin]) administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
466614|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466615|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466616|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466617|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466618|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466619|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
469017|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
466629|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
466620|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466621|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
466622|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466623|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
466624|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466625|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
466626|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466627|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
466628|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466656|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466657|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
467164|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
466630|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466631|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
466632|NCT00643565|E2|Reported Event|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
466633|NCT00643565|E1|Reported Event|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
466634|NCT00643578|B1|Baseline|All Participants|A single dose of 12 mcg and 24 mcg, on separate days, of formoterol were given.
466635|NCT00643578|P2|Participant Flow|Formoterol 24 First|a single dose of 24 mcg of formoterol was given first, then 12 mcg of formoterol
466636|NCT00643578|P1|Participant Flow|Formoterol 12 First|a single dose of 12 mcg of formoterol was given first, then 24 mcg of formoterol
466637|NCT00643578|O2|Outcome|24 Mcg of Formoterol|high dose
466638|NCT00643578|O1|Outcome|12 Mcg of Formoterol|low dose
466639|NCT00643578|O2|Outcome|24 Mcg Formoterol|high dose
466640|NCT00643578|O1|Outcome|12 Mcg Formoterol|low dose
466641|NCT00643578|E2|Reported Event|Formoterol 24|A single dose of 24 mcg of formoterol was administered.
466642|NCT00643578|E1|Reported Event|Formoterol 12|A single dose of 12 mcg of formoterol was administered.
466643|NCT00643604|B1|Baseline|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466644|NCT00643604|P1|Participant Flow|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466645|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466646|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466647|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466648|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466649|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466650|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466651|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466652|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466653|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466654|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466655|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
469018|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
466658|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466659|NCT00643604|E1|Reported Event|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
466660|NCT00643682|B3|Baseline|Total|Total of all reporting groups
469051|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
466662|NCT00643682|B1|Baseline|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
466663|NCT00643682|P2|Participant Flow|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
466664|NCT00643682|P1|Participant Flow|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
466665|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
466666|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
466667|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
466668|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
466669|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
466670|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
466671|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
466672|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
466673|NCT00643682|E2|Reported Event|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
466674|NCT00643682|E1|Reported Event|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
466675|NCT00643760|B6|Baseline|Total|Total of all reporting groups
466676|NCT00643760|B5|Baseline|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466677|NCT00643760|B4|Baseline|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466678|NCT00643760|B3|Baseline|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466679|NCT00643760|B2|Baseline|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466680|NCT00643760|B1|Baseline|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466681|NCT00643760|P5|Participant Flow|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466682|NCT00643760|P4|Participant Flow|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466683|NCT00643760|P3|Participant Flow|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466684|NCT00643760|P2|Participant Flow|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466685|NCT00643760|P1|Participant Flow|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466686|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466687|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466688|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466689|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466690|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466691|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466692|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466693|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
469019|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
466694|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466695|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466696|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466697|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466698|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466699|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466700|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466701|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466702|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466703|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466704|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466705|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466706|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466707|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466708|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466709|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466710|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466711|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466712|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466713|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466714|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466715|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466716|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466717|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466718|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466719|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466720|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466721|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
467165|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
466722|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466723|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
467176|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
466724|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466725|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466726|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466727|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466728|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466729|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466730|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466731|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466732|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466733|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466734|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466735|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466736|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466737|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466738|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466739|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466740|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466741|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466742|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466743|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466744|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466745|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466746|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466747|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466748|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466749|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466821|NCT00643916|P6|Participant Flow|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
466750|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466751|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466752|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466753|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466754|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466755|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466756|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466757|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466758|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466759|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466760|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466761|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466762|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466763|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466764|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466765|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466766|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466767|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466768|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466769|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466770|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466771|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466772|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466773|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466774|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466775|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466776|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466777|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466822|NCT00643916|P5|Participant Flow|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
466778|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466779|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466780|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466781|NCT00643760|E5|Reported Event|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
466782|NCT00643760|E4|Reported Event|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466783|NCT00643760|E3|Reported Event|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466784|NCT00643760|E2|Reported Event|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
466785|NCT00643760|E1|Reported Event|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
466786|NCT00643851|B4|Baseline|Total|Total of all reporting groups
466787|NCT00643851|B3|Baseline|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
466788|NCT00643851|B2|Baseline|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
466789|NCT00643851|B1|Baseline|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
466790|NCT00643851|P3|Participant Flow|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
466791|NCT00643851|P2|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
466792|NCT00643851|P1|Participant Flow|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
466793|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
466794|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
466795|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
466796|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
466797|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
466798|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
466799|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
466800|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
466801|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
466802|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
466803|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
466804|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
466805|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
466806|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
466807|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
466808|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
466809|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
466810|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
466811|NCT00643851|E3|Reported Event|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
466812|NCT00643851|E2|Reported Event|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
466813|NCT00643851|E1|Reported Event|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
466814|NCT00643916|B7|Baseline|Total|Total of all reporting groups
466815|NCT00643916|B6|Baseline|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
466816|NCT00643916|B5|Baseline|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
466817|NCT00643916|B4|Baseline|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
466818|NCT00643916|B3|Baseline|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
466819|NCT00643916|B2|Baseline|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
466820|NCT00643916|B1|Baseline|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
466823|NCT00643916|P4|Participant Flow|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
466824|NCT00643916|P3|Participant Flow|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
466825|NCT00643916|P2|Participant Flow|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
466826|NCT00643916|P1|Participant Flow|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
466827|NCT00643916|O6|Outcome|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
466828|NCT00643916|O5|Outcome|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
466829|NCT00643916|O4|Outcome|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
466830|NCT00643916|O3|Outcome|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
466831|NCT00643916|O2|Outcome|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
466832|NCT00643916|O1|Outcome|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
466833|NCT00643916|O6|Outcome|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
466834|NCT00643916|O5|Outcome|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
466835|NCT00643916|O4|Outcome|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
466836|NCT00643916|O3|Outcome|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
466837|NCT00643916|O2|Outcome|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
466838|NCT00643916|O1|Outcome|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
466839|NCT00643916|E6|Reported Event|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
466840|NCT00643916|E5|Reported Event|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
466841|NCT00643916|E4|Reported Event|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
466842|NCT00643916|E3|Reported Event|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
466843|NCT00643916|E2|Reported Event|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
466844|NCT00643916|E1|Reported Event|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
466845|NCT00644059|B4|Baseline|Total|Total of all reporting groups
466846|NCT00644059|B3|Baseline|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466847|NCT00644059|B2|Baseline|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466848|NCT00644059|B1|Baseline|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466849|NCT00644059|P3|Participant Flow|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of Tick-borne encephalitis (TBE) vaccine
466850|NCT00644059|P2|Participant Flow|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466851|NCT00644059|P1|Participant Flow|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466852|NCT00644059|O3|Outcome|Flu-Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of
466853|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466854|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466855|NCT00644059|O3|Outcome|Flu-Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466856|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466857|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466858|NCT00644059|O3|Outcome|Non-flu Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
466859|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466860|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466861|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466862|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466863|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466864|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466865|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466866|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466867|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466868|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466869|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466870|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466871|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466872|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466873|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466874|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466875|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
466876|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466877|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466878|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
466879|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466880|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466881|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466882|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466883|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466884|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466885|NCT00644059|O3|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466886|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466887|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466888|NCT00644059|O3|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466889|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466890|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466891|NCT00644059|O6|Outcome|Flu Control (6 to < 72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466892|NCT00644059|O5|Outcome|Non-flu Control (6 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466893|NCT00644059|O4|Outcome|TIV-adj (6 to < 72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466894|NCT00644059|O3|Outcome|Flu-control (6 to < 36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466925|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466895|NCT00644059|O2|Outcome|Non-flu Control (6 to < 36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466896|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
466897|NCT00644059|O3|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466898|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466899|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466900|NCT00644059|O6|Outcome|Flu Control (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466901|NCT00644059|O5|Outcome|Non-flu Control (36 to < 72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466902|NCT00644059|O4|Outcome|TIV-adj (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466903|NCT00644059|O3|Outcome|Flu Control (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466904|NCT00644059|O2|Outcome|Non-flu Control (6 to < 36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466905|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466906|NCT00644059|O6|Outcome|Flu Control (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466907|NCT00644059|O5|Outcome|Non-flu Control (36 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466908|NCT00644059|O4|Outcome|TIV-adj (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466909|NCT00644059|O3|Outcome|Flu Control (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466910|NCT00644059|O2|Outcome|Non-flu Control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466911|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466912|NCT00644059|O6|Outcome|Non-Flu-control (6 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466913|NCT00644059|O5|Outcome|Flu-control (6 to <72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466914|NCT00644059|O4|Outcome|TIV-adj (6 to <72 Months )|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466915|NCT00644059|O3|Outcome|Non-Flu-control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466916|NCT00644059|O2|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466917|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466918|NCT00644059|O6|Outcome|Non-Flu-control (36 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466919|NCT00644059|O5|Outcome|Non-Flu-control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466920|NCT00644059|O4|Outcome|Flu-control (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466921|NCT00644059|O3|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466922|NCT00644059|O2|Outcome|TIV-adj (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466923|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
467166|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
466924|NCT00644059|O2|Outcome|Non-flu Control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466926|NCT00644059|O2|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466927|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
466928|NCT00644059|E6|Reported Event|Non-Flu-control (TBE Vaccine)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466929|NCT00644059|E5|Reported Event|Non-Flu-control (TBE/Men C Vaccine)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
466930|NCT00644059|E4|Reported Event|Flu-control_0.5|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466931|NCT00644059|E3|Reported Event|Flu-control_0.25|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
466932|NCT00644059|E2|Reported Event|TIV-adj_0.5|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466933|NCT00644059|E1|Reported Event|TIV-adj_0.25|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
466934|NCT00644189|B1|Baseline|Clofarabine Phase I|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
466935|NCT00644189|P4|Participant Flow|Clofarabine: 3 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
466936|NCT00644189|P3|Participant Flow|Clofarabine 4 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
466937|NCT00644189|P2|Participant Flow|Clofarabine 2 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
466938|NCT00644189|P1|Participant Flow|Clofarabine 1 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
466939|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
466940|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
466941|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
466942|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
466943|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
466944|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
466945|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
466946|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
466947|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
466948|NCT00644189|O1|Outcome|Phase I-II|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
466949|NCT00644189|E1|Reported Event|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
466950|NCT00644228|B3|Baseline|Total|Total of all reporting groups
466951|NCT00644228|B2|Baseline|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
466952|NCT00644228|B1|Baseline|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
466953|NCT00644228|P2|Participant Flow|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
467064|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467167|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
466954|NCT00644228|P1|Participant Flow|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
467322|NCT00653068|O1|Outcome|All Patients|Experimental
466955|NCT00644228|O2|Outcome|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
466956|NCT00644228|O1|Outcome|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
466957|NCT00644228|O2|Outcome|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
466958|NCT00644228|O1|Outcome|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
466959|NCT00644228|O2|Outcome|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
466960|NCT00644228|O1|Outcome|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
466961|NCT00644228|E2|Reported Event|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
466962|NCT00644228|E1|Reported Event|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
Lenalidomide: Given PO"
466963|NCT00644280|B3|Baseline|Total|Total of all reporting groups
466964|NCT00644280|B2|Baseline|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
466965|NCT00644280|B1|Baseline|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
466966|NCT00644280|P2|Participant Flow|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
466967|NCT00644280|P1|Participant Flow|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
466968|NCT00644280|O2|Outcome|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
466969|NCT00644280|O1|Outcome|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
466970|NCT00644280|O2|Outcome|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
466971|NCT00644280|O1|Outcome|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
466972|NCT00644280|E2|Reported Event|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
466973|NCT00644280|E1|Reported Event|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
466974|NCT00644332|B1|Baseline|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466975|NCT00644332|P1|Participant Flow|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466976|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
469020|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
467067|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467068|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
466977|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466978|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466979|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466980|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466981|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466982|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466983|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466984|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466985|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466986|NCT00644332|E1|Reported Event|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
466987|NCT00644592|B3|Baseline|Total|Total of all reporting groups
466988|NCT00644592|B2|Baseline|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
466989|NCT00644592|B1|Baseline|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
466990|NCT00644592|P2|Participant Flow|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
466991|NCT00644592|P1|Participant Flow|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
466992|NCT00644592|O2|Outcome|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
466993|NCT00644592|O1|Outcome|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
466994|NCT00644592|E2|Reported Event|2 Placebo|4 weeks of placebo.
466995|NCT00644592|E1|Reported Event|1-Fenofibrate|4 weeks of drug at 160 mg orally per day
466996|NCT00644657|B1|Baseline|Clopidogrel|All 27 subjects received a 300 mg loading dose of clopidogrel
466997|NCT00644657|P1|Participant Flow|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
466998|NCT00644657|O1|Outcome|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
466999|NCT00644657|O1|Outcome|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
467000|NCT00644657|E1|Reported Event|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
467001|NCT00644787|B1|Baseline|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
467168|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467002|NCT00644787|P3|Participant Flow|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467003|NCT00644787|P2|Participant Flow|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467004|NCT00644787|P1|Participant Flow|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
467005|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467006|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467007|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
467008|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467009|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467010|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
467011|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467012|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467013|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
467014|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467015|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467065|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467169|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467016|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
467017|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467018|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467019|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467020|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467021|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
467022|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467023|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467024|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
467025|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467026|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467027|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
467028|NCT00644787|E3|Reported Event|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467029|NCT00644787|E2|Reported Event|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
467066|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467170|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467030|NCT00644787|E1|Reported Event|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
467031|NCT00644917|B1|Baseline|Xenaderm vs. Vehicle - Subjects Acted as Own Comparator|Subjects received duplicate 20 mg applications of Xenaderm Ointment and Xenaderm vehicle contained in Finn Chambers, to the left sides of their backs
467032|NCT00644917|P1|Participant Flow|Xenaderm Ointment - Subjects Acted as Own Comparator|Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
467033|NCT00644917|O5|Outcome|Xenaderm Vehicle - Non-irradiated|20 mg samples of Xenaderm Vehicle applied in a Finn Chambers to test site the left side of each subject's back - not irradiated
467034|NCT00644917|O4|Outcome|Xenaderm Ointment - Non-irradiated|20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - not irradiated
467035|NCT00644917|O3|Outcome|Control - Irradiated|test site was covered with an empty Finn Chamber as a control site - then irradiated
467036|NCT00644917|O2|Outcome|Xenaderm Vehicle - Irradiated|20 mg sample of Vehicle applied in Finn Chamber to test site on the left side of each subject's back - then irradiated
467037|NCT00644917|O1|Outcome|Xenaderm Ointment - Irradiated|20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - then irradiated
467038|NCT00644917|E1|Reported Event|Xenaderm Ointment - Subjects Acted as Own Comparator|Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
467039|NCT00644969|B3|Baseline|Total|Total of all reporting groups
467040|NCT00644969|B2|Baseline|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467041|NCT00644969|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467042|NCT00644969|P2|Participant Flow|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467043|NCT00644969|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467044|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467045|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467046|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467047|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467048|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467049|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467050|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467051|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467052|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467053|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467054|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467055|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467056|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467057|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467058|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467059|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467060|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467061|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467062|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467063|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467158|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467069|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467070|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467071|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467072|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467073|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467074|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467075|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467076|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467077|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467078|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467079|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467080|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467081|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467082|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467083|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467084|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467085|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467086|NCT00644969|E2|Reported Event|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
467087|NCT00644969|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
467088|NCT00644995|B3|Baseline|Total|Total of all reporting groups
467089|NCT00644995|B2|Baseline|Step Up|Proactive phone counseling addressing smoking, depression, and physical activity (PA)
467090|NCT00644995|B1|Baseline|Usual Care|Advice to quit smoking and referral to standard care
467091|NCT00644995|P2|Participant Flow|Step Up|proactive phone counseling addressing smoking, depression, and PA
467092|NCT00644995|P1|Participant Flow|Usual Care|Advice to quit and referral to standard care
467093|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
467094|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
467095|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
467096|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
467097|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
467098|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
467099|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
467100|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
467101|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
467102|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
467103|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression and PA
467104|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
467105|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression and physical activity
467106|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
467107|NCT00644995|E2|Reported Event|Step Up|Proactive phone counseling addressing smoking, depression, and physical activity
467108|NCT00644995|E1|Reported Event|Usual Care|Advice to quit and referral to standard care
467109|NCT00645047|B3|Baseline|Total|Total of all reporting groups
467110|NCT00645047|B2|Baseline|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467111|NCT00645047|B1|Baseline|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467112|NCT00645047|P2|Participant Flow|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467159|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467113|NCT00645047|P1|Participant Flow|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467173|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467114|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467115|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467116|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467117|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467118|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467119|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467120|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467121|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467122|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467123|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467124|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467125|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467126|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467127|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467128|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467129|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467130|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467131|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467132|NCT00645047|E2|Reported Event|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.
In-Person CBT: In-Person Provision Of Cognitive Therapy"
467133|NCT00645047|E1|Reported Event|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.
Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
467134|NCT00645099|B3|Baseline|Total|Total of all reporting groups
467135|NCT00645099|B2|Baseline|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467136|NCT00645099|B1|Baseline|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467137|NCT00645099|P2|Participant Flow|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467138|NCT00645099|P1|Participant Flow|Paliperidone Extended Release (ER)|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467139|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467140|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467141|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467142|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467143|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467144|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467145|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467146|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467147|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467148|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467149|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467150|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467151|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467152|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467153|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467154|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467155|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467156|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467157|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467171|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467172|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467177|NCT00645099|E2|Reported Event|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
467178|NCT00645099|E1|Reported Event|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
467179|NCT00645164|B1|Baseline|Xenaderm|Subject serves as own control
467180|NCT00645164|P1|Participant Flow|Xenaderm|Subject serves as own control
467181|NCT00645164|O1|Outcome|Xenaderm|Subject serves as own control
467182|NCT00645164|E1|Reported Event|Xenaderm|Subject serves as own control
467183|NCT00645333|B1|Baseline|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
467184|NCT00645333|P1|Participant Flow|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
467185|NCT00645333|O1|Outcome|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
467186|NCT00645333|O1|Outcome|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
467187|NCT00645333|E1|Reported Event|MK-0752|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
467188|NCT00645359|B1|Baseline|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
467189|NCT00645359|P1|Participant Flow|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
467190|NCT00645359|O1|Outcome|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
467191|NCT00645359|O1|Outcome|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
467192|NCT00645359|E1|Reported Event|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
467193|NCT00645411|B5|Baseline|Total|Total of all reporting groups
467194|NCT00645411|B4|Baseline|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
467195|NCT00645411|B3|Baseline|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
467196|NCT00645411|B2|Baseline|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
467197|NCT00645411|B1|Baseline|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
467198|NCT00645411|P4|Participant Flow|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
467199|NCT00645411|P3|Participant Flow|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
467200|NCT00645411|P2|Participant Flow|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
467201|NCT00645411|P1|Participant Flow|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
467202|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg- derived trivalent influenza vaccine.
467203|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
467204|NCT00645411|O2|Outcome|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
467205|NCT00645411|O1|Outcome|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
467206|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
467207|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
467208|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
467209|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
467210|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
467211|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
467212|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
467632|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
467213|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
467214|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
467215|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
467216|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
467217|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
467218|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
467219|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
467220|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
467221|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine
467222|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
467223|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
467224|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg - derived trivalent influenza vaccine.
467225|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
467226|NCT00645411|E6|Reported Event|Cohort 3 eTIV (3-8 Yrs; 2nd Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
467227|NCT00645411|E5|Reported Event|Cohort 3 cTIV (3-8 Yrs; 2nd Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
467228|NCT00645411|E4|Reported Event|Cohort 3 eTIV (3-8 Yrs; 1st Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
467229|NCT00645411|E3|Reported Event|Cohort 3 cTIV (3-8 Yrs; 1st Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
467230|NCT00645411|E2|Reported Event|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
467231|NCT00645411|E1|Reported Event|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
467232|NCT00652834|B1|Baseline|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.
Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.
Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
467233|NCT00652834|P1|Participant Flow|Kidney Transplant Recipients With GI Symptoms|"Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.
Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
467234|NCT00652834|O1|Outcome|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.
Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.
Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
467235|NCT00652834|E1|Reported Event|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.
Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.
Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
467236|NCT00652899|B1|Baseline|All Patients Enrolled|This group includes all patients consented to participate in this study.
467237|NCT00652899|P1|Participant Flow|All Patients Enrolled|This group includes all patients consented to participate in this study.
467238|NCT00652899|O2|Outcome|No Total Body Irradiation|This group includes patients that received chemotherapy, infusion of natural killer cells and no total body irradiation per protocol.
467239|NCT00652899|O1|Outcome|Total Body Irradiation|This group includes patients that received chemotherapy, infusion of natural killer cells and total body irradiation per protocol.
467240|NCT00652899|O2|Outcome|Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
467241|NCT00652899|O1|Outcome|No Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and no total body irradiation.
467242|NCT00652899|O2|Outcome|Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
467243|NCT00652899|O1|Outcome|No Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and no total body irradiation.
469021|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
467244|NCT00652899|O1|Outcome|Ovarian/Fallopian Tube/Peritoneal Cancer Patients|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and/or total body irradiation per protocol (200 Gy on Day 1 preceding natural killer cell infusion).
467245|NCT00652899|E1|Reported Event|All Patients Enrolled|This group includes all patients consented to participate in this study.
467246|NCT00652938|B4|Baseline|Total|Total of all reporting groups
467247|NCT00652938|B3|Baseline|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467248|NCT00652938|B2|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467249|NCT00652938|B1|Baseline|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467250|NCT00652938|P3|Participant Flow|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467251|NCT00652938|P2|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467252|NCT00652938|P1|Participant Flow|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467253|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467254|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467255|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467256|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467257|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467258|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467259|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467260|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467261|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467262|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467263|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467264|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467265|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467266|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467267|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467268|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467269|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467270|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467271|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467272|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467273|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467274|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467275|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467276|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467277|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467278|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467279|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467280|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467281|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467282|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467283|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467284|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467323|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
467285|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467286|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467287|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467288|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467289|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467290|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467291|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467292|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467293|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467294|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467295|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467296|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467297|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467298|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467299|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467300|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467301|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467302|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467303|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467304|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467305|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467306|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467307|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467308|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467309|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467310|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467311|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467312|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467313|NCT00652938|E3|Reported Event|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467314|NCT00652938|E2|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
467315|NCT00652938|E1|Reported Event|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
467316|NCT00653068|B5|Baseline|Total|Total of all reporting groups
467317|NCT00653068|B4|Baseline|Stratum IV|Older children with INI1 mutation only based diagnosis.
467318|NCT00653068|B3|Baseline|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
467319|NCT00653068|B2|Baseline|Stratum II|Infants with INI1 mutation only based diagnosis (histology is not consistent with AT/RT).
467320|NCT00653068|B1|Baseline|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
467454|NCT00654641|B2|Baseline|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
467321|NCT00653068|P1|Participant Flow|Treatment|"Within 2-6 weeks after induction therapy or radiation therapy, patients receive high-dose carboplatin IV and high-dose thiotepa IV on days 1 and 2 and undergo autologous PBSC rescue on approximately day 4. Patients also receive G-CSF IV or SC once daily until ANC recovers.
Consolidation therapy followed by stem cell rescue repeats every 28 days for 3 courses (C) and 3D-CRT to the brain (and the spine if needed) 5 days a week for 5-6 weeks (R), the order of which depends on patient age, in the absence of disease progression or unacceptable toxicity."
467324|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
467325|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
467326|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
467327|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
467328|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
467329|NCT00653068|E2|Reported Event|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
467330|NCT00653068|E1|Reported Event|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT
467331|NCT00653133|B3|Baseline|Total|Total of all reporting groups
467332|NCT00653133|B2|Baseline|NSPNB|Stimulator guided nerve block
467333|NCT00653133|B1|Baseline|USPNB|ultrasound imaging guided peripheral nerve block
467334|NCT00653133|P2|Participant Flow|NSPNB|Stimulator guided nerve block
467335|NCT00653133|P1|Participant Flow|USPNB|ultrasound imaging guided peripheral nerve block
467336|NCT00653133|O2|Outcome|NSPNB|Nerve Stimulator guided peripheral nerve block
467337|NCT00653133|O1|Outcome|USPNB|Ultrasound imaging guided peripheral nerve block
467338|NCT00653133|E2|Reported Event|NSPNB|Stimulator guided nerve block
467339|NCT00653133|E1|Reported Event|USPNB|ultrasound imaging guided peripheral nerve block
467340|NCT00653159|B3|Baseline|Total|Total of all reporting groups
467341|NCT00653159|B2|Baseline|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
467342|NCT00653159|B1|Baseline|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
467343|NCT00653159|P2|Participant Flow|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
467344|NCT00653159|P1|Participant Flow|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
467345|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
467346|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
467347|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
467348|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
467349|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
467350|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
467351|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
467352|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
467353|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
467354|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
467355|NCT00653159|E2|Reported Event|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
467356|NCT00653159|E1|Reported Event|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
467357|NCT00654420|B5|Baseline|Total|Total of all reporting groups
467358|NCT00654420|B4|Baseline|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467359|NCT00654420|B3|Baseline|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467360|NCT00654420|B2|Baseline|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467361|NCT00654420|B1|Baseline|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467362|NCT00654420|P4|Participant Flow|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467363|NCT00654420|P3|Participant Flow|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467364|NCT00654420|P2|Participant Flow|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467365|NCT00654420|P1|Participant Flow|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab intravenously (IV) at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467366|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467398|NCT00654498|O1|Outcome|Pramipexole|
467399|NCT00654498|O2|Outcome|Placebo|
467400|NCT00654498|O1|Outcome|Pramipexole|
467367|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467368|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467369|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467370|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467371|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467372|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467373|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467374|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467375|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467376|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467377|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467378|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467379|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467380|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467381|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467382|NCT00654420|E4|Reported Event|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467383|NCT00654420|E3|Reported Event|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
467384|NCT00654420|E2|Reported Event|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467385|NCT00654420|E1|Reported Event|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
467386|NCT00654498|B3|Baseline|Total|Total of all reporting groups
467387|NCT00654498|B2|Baseline|Placebo|
467388|NCT00654498|B1|Baseline|Pramipexole|
467389|NCT00654498|P2|Participant Flow|Placebo|1 tablet (Pramipexole 0.125 mg matching placebo tablet), or 1 or 2 or 3 tablets (Pramipexole 0.25 mg matching placebo tablet), once daily
467390|NCT00654498|P1|Participant Flow|Pramipexole|4 weeks of individual dose titration starting with 0.125 mg pramipexole, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily
467391|NCT00654498|O2|Outcome|Placebo|
467392|NCT00654498|O1|Outcome|Pramipexole|
467393|NCT00654498|O2|Outcome|Placebo|
467394|NCT00654498|O1|Outcome|Pramipexole|
467395|NCT00654498|O2|Outcome|Placebo|
467396|NCT00654498|O1|Outcome|Pramipexole|
467397|NCT00654498|O2|Outcome|Placebo|
467418|NCT00654511|B4|Baseline|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
467419|NCT00654511|B3|Baseline|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
467420|NCT00654511|B2|Baseline|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
467421|NCT00654511|B1|Baseline|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
467422|NCT00654511|P4|Participant Flow|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
467423|NCT00654511|P3|Participant Flow|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
467424|NCT00654511|P2|Participant Flow|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
467425|NCT00654511|P1|Participant Flow|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
467426|NCT00654511|O4|Outcome|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
467427|NCT00654511|O3|Outcome|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
467428|NCT00654511|O2|Outcome|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
467429|NCT00654511|O1|Outcome|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
467430|NCT00654511|O4|Outcome|Dexmedetomidine 4 Micrograms/Kilogram IV|
467431|NCT00654511|O3|Outcome|Dexmedetomidine 2 Microgram/Kilogram IV|
467432|NCT00654511|O2|Outcome|Fentanyl 2 Micrograms/Kilogram IV|
467433|NCT00654511|O1|Outcome|Fentanyl 1 Microgram/Kilogram IV|
467434|NCT00654511|E4|Reported Event|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
467435|NCT00654511|E3|Reported Event|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
467436|NCT00654511|E2|Reported Event|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
467437|NCT00654511|E1|Reported Event|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
467438|NCT00654628|B1|Baseline|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467439|NCT00654628|P1|Participant Flow|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467440|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467441|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467442|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467443|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467444|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467445|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467446|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467447|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467448|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467449|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467450|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467451|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467452|NCT00654628|E1|Reported Event|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
467453|NCT00654641|B3|Baseline|Total|Total of all reporting groups
467455|NCT00654641|B1|Baseline|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
467456|NCT00654641|P2|Participant Flow|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
467457|NCT00654641|P1|Participant Flow|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
467458|NCT00654641|O2|Outcome|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
467459|NCT00654641|O1|Outcome|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
467460|NCT00654641|E2|Reported Event|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
467461|NCT00654641|E1|Reported Event|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
467462|NCT00654654|B1|Baseline|Autologous Fibroblasts|Patients received treatment with autologous fibroblasts to multiple facial regions
467463|NCT00654654|P1|Participant Flow|Autologous Fibroblasts|Patients received treatment with autologous fibroblasts to multiple facial regions
467464|NCT00654654|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous human fibroblasts
467465|NCT00654654|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous human fibroblasts
467466|NCT00654654|E1|Reported Event|Active|Patients treated with autologous human fibroblasts
467467|NCT00654745|B1|Baseline|Aml + Olm + Hctz|amlodipine (aml) + olmesartan medoxomil (olm)+ hhdrochlorothiazide (hctz) is total number enrolled. Each group is the number of participants that were titrated to that dosing regimen as per the protocol. The total number of participants of the individual groups does not (and should not) equal the total number enrolled.
467468|NCT00654745|P1|Participant Flow|Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide|Participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467469|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467470|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467471|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467472|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467473|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467474|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467475|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467476|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467477|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467478|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467479|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467480|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467481|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467482|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467483|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467484|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467485|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467486|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467487|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467488|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467489|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467490|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467491|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467492|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467493|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467494|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467495|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467496|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467497|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467498|NCT00654745|E7|Reported Event|Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
467499|NCT00654745|E6|Reported Event|Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
467500|NCT00654745|E5|Reported Event|Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
467501|NCT00654745|E4|Reported Event|Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
467502|NCT00654745|E3|Reported Event|Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
467503|NCT00654745|E2|Reported Event|Start - Amlodipine 5 mg|All participants started trial on Amlodipine 5 mg.
467504|NCT00654745|E1|Reported Event|ALL - Aml + Olm + Hctz|Summary of ALL participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
467505|NCT00654784|B3|Baseline|Total|Total of all reporting groups
467506|NCT00654784|B2|Baseline|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
467507|NCT00654784|B1|Baseline|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
467508|NCT00654784|P2|Participant Flow|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
467509|NCT00654784|P1|Participant Flow|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
467510|NCT00654784|O2|Outcome|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
467511|NCT00654784|O1|Outcome|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
467512|NCT00654784|E2|Reported Event|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
467513|NCT00654784|E1|Reported Event|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
467514|NCT00654875|B3|Baseline|Total|Total of all reporting groups
467641|NCT00655551|B3|Baseline|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
467515|NCT00654875|B2|Baseline|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
467516|NCT00654875|B1|Baseline|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
467517|NCT00654875|P2|Participant Flow|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
467518|NCT00654875|P1|Participant Flow|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
467519|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
467520|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
467521|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
467522|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
467523|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
467524|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
467525|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
467526|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
467527|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
467528|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
467529|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
467530|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
467531|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
467532|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
467533|NCT00654875|E2|Reported Event|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
467534|NCT00654875|E1|Reported Event|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
467535|NCT00654901|B5|Baseline|Total|Total of all reporting groups
467642|NCT00655551|B2|Baseline|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
467536|NCT00654901|B4|Baseline|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
467537|NCT00654901|B3|Baseline|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467538|NCT00654901|B2|Baseline|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467539|NCT00654901|B1|Baseline|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467540|NCT00654901|P4|Participant Flow|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
467541|NCT00654901|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467542|NCT00654901|P2|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch 2 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467543|NCT00654901|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467544|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
467545|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467546|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467547|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467548|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
467628|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
467629|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
467549|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467550|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467551|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467643|NCT00655551|B1|Baseline|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
467552|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
467553|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467554|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467555|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467556|NCT00654901|E4|Reported Event|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
467557|NCT00654901|E3|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467558|NCT00654901|E2|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467559|NCT00654901|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
467560|NCT00654927|B1|Baseline|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
467561|NCT00654927|P1|Participant Flow|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
467562|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
467563|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
467564|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
467565|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
467566|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
467567|NCT00654927|E1|Reported Event|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.
(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
467568|NCT00654940|B3|Baseline|Total|Total of all reporting groups
467569|NCT00654940|B2|Baseline|Placebo Then Pregabalin|Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.
467570|NCT00654940|B1|Baseline|Pregabalin Then Placebo|Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14. Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.
467630|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
467571|NCT00654940|P2|Participant Flow|Placebo First Then Pregabalin|Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14.
467572|NCT00654940|P1|Participant Flow|Pregabalin First Then Placebo|Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
467573|NCT00654940|O2|Outcome|Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
467574|NCT00654940|O1|Outcome|Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
467575|NCT00654940|O2|Outcome|Placebo/Pregabalin|Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
469052|NCT00659490|E3|Reported Event|Naproxen|Naproxen 500mg given pre-surgery
467576|NCT00654940|O1|Outcome|Pregabalin/Placebo|Pregabalin Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
467577|NCT00654940|O4|Outcome|Period 2: Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
467578|NCT00654940|O3|Outcome|Period 2: Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
467579|NCT00654940|O2|Outcome|Period 1: Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
467580|NCT00654940|O1|Outcome|Period 1: Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
467581|NCT00654940|E2|Reported Event|Placebo|Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.
467582|NCT00654940|E1|Reported Event|Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.
467583|NCT00654953|B4|Baseline|Total|Total of all reporting groups
467584|NCT00654953|B3|Baseline|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
467585|NCT00654953|B2|Baseline|Active Group: Sertraline Alone|sertraline (200 mg/day)
467586|NCT00654953|B1|Baseline|Placebo Group|Placebo capsules
467587|NCT00654953|P3|Participant Flow|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
467588|NCT00654953|P2|Participant Flow|Active Group: Sertraline Alone|sertraline (200 mg/day)
467589|NCT00654953|P1|Participant Flow|Placebo Group|Placebo capsules
467590|NCT00654953|O3|Outcome|Sertraline Plus Gabapentin|
467591|NCT00654953|O2|Outcome|Sertraline|
467592|NCT00654953|O1|Outcome|Placebo|
467593|NCT00654953|E3|Reported Event|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
467594|NCT00654953|E2|Reported Event|Active Group: Sertraline Alone|sertraline (200 mg/day)
467595|NCT00654953|E1|Reported Event|Placebo Group|Placebo capsules
467596|NCT00654992|B3|Baseline|Total|Total of all reporting groups
467597|NCT00654992|B2|Baseline|Placebo Group|received normal saline intraveously following induction of anesthesia
467598|NCT00654992|B1|Baseline|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
467599|NCT00654992|P2|Participant Flow|Placebo Group|received normal saline intraveously following induction of anesthesia
467600|NCT00654992|P1|Participant Flow|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
467601|NCT00654992|O2|Outcome|Placebo Group|received normal saline intraveously following induction of anesthesia
467602|NCT00654992|O1|Outcome|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
467603|NCT00654992|O2|Outcome|Placebo Group|received normal saline intraveously following induction of anesthesia
467604|NCT00654992|O1|Outcome|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
467605|NCT00655083|B3|Baseline|Total|Total of all reporting groups
467606|NCT00655083|B2|Baseline|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
467607|NCT00655083|B1|Baseline|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
467608|NCT00655083|P2|Participant Flow|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
467609|NCT00655083|P1|Participant Flow|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
467610|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
467611|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
467612|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
467613|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
467614|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
467615|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
467616|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
467617|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
467618|NCT00655083|E2|Reported Event|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
467619|NCT00655083|E1|Reported Event|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
467620|NCT00655356|B3|Baseline|Total|Total of all reporting groups
467621|NCT00655356|B2|Baseline|Placebo|Patients treated with placebo solution
467622|NCT00655356|B1|Baseline|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
467623|NCT00655356|P2|Participant Flow|Placebo|Patients treated with placebo solution
467624|NCT00655356|P1|Participant Flow|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
467625|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
467626|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
467627|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
467633|NCT00655356|E2|Reported Event|Placebo|Patients treated with placebo solution.
467634|NCT00655356|E1|Reported Event|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
467635|NCT00655486|B1|Baseline|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
467636|NCT00655486|P1|Participant Flow|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
467637|NCT00655486|O1|Outcome|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
467638|NCT00655486|O1|Outcome|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
467639|NCT00655486|E1|Reported Event|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
467640|NCT00655551|B4|Baseline|Total|Total of all reporting groups
467644|NCT00655551|P3|Participant Flow|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
467645|NCT00655551|P2|Participant Flow|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
467646|NCT00655551|P1|Participant Flow|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
467647|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
467648|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
467649|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
467650|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
467651|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
467652|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
467653|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
467654|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
467655|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
467656|NCT00655551|E3|Reported Event|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
467657|NCT00655551|E2|Reported Event|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
467658|NCT00655551|E1|Reported Event|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
467659|NCT00655564|B1|Baseline|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
467660|NCT00655564|P1|Participant Flow|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
467661|NCT00655564|O1|Outcome|Alefacept|All subjects received alefacept injections per FDA dosing guidelines for the duration of the 52 weeks study
467662|NCT00655564|O1|Outcome|Alefacept|Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.
467663|NCT00655564|E1|Reported Event|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
467664|NCT00655629|B3|Baseline|Total|Total of all reporting groups
467665|NCT00655629|B2|Baseline|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467666|NCT00655629|B1|Baseline|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467667|NCT00655629|P2|Participant Flow|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467668|NCT00655629|P1|Participant Flow|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467669|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467670|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467671|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467672|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467673|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467674|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467675|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467676|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467677|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467678|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467679|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
469053|NCT00659490|E2|Reported Event|Placebo|Placebo given pre-surgery
467680|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467681|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467682|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467683|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467684|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467685|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467686|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467687|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467688|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467689|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467690|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467691|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467692|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467693|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467694|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467695|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467696|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467697|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467698|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467699|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467700|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467701|NCT00655629|E2|Reported Event|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467702|NCT00655629|E1|Reported Event|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
467703|NCT00655642|B5|Baseline|Total|Total of all reporting groups
467704|NCT00655642|B4|Baseline|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
467705|NCT00655642|B3|Baseline|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
467706|NCT00655642|B2|Baseline|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
467707|NCT00655642|B1|Baseline|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
467708|NCT00655642|P4|Participant Flow|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
469022|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
467709|NCT00655642|P3|Participant Flow|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
467710|NCT00655642|P2|Participant Flow|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
467711|NCT00655642|P1|Participant Flow|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
467712|NCT00655642|O4|Outcome|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
467713|NCT00655642|O3|Outcome|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
467714|NCT00655642|O2|Outcome|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
467715|NCT00655642|O1|Outcome|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
467716|NCT00655642|E4|Reported Event|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
467717|NCT00655642|E3|Reported Event|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
467718|NCT00655642|E2|Reported Event|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
467719|NCT00655642|E1|Reported Event|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
467720|NCT00655668|B1|Baseline|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
467721|NCT00655668|P1|Participant Flow|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
467722|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
467723|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
467724|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
467725|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
467726|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
467727|NCT00655668|E1|Reported Event|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
467728|NCT00655733|B3|Baseline|Total|Total of all reporting groups
467729|NCT00655733|B2|Baseline|Placebo|Placebo
467730|NCT00655733|B1|Baseline|HMPL004|HMPL004 1200mg/d
467731|NCT00655733|P2|Participant Flow|Placebo|Placebo
467732|NCT00655733|P1|Participant Flow|HMPL004|HMPL004 1200mg/d
467733|NCT00655733|O2|Outcome|Placebo|Placebo
467734|NCT00655733|O1|Outcome|HMPL004|HMPL004 1200mg/d
467735|NCT00655733|E2|Reported Event|Placebo|Placebo
467736|NCT00655733|E1|Reported Event|HMPL004|HMPL004 1200mg/d
467737|NCT00655746|B1|Baseline|Dasatinib/Omeprazole|Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
467738|NCT00655746|P1|Participant Flow|Dasatinib/Omeprazole|Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
467739|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
467740|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
467741|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
467742|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
467743|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
467744|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
467745|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
467746|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
467747|NCT00655746|O4|Outcome|All Participants|
467748|NCT00655746|O3|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
467749|NCT00655746|O2|Outcome|Omeprazole (Days 2-5)|40-mg oral omeprazole
467750|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
467751|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
467752|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
467753|NCT00655746|E1|Reported Event|BMS-354825 + Omeprazole|
467754|NCT00655811|B1|Baseline|Capsaicin and Placebo|"0.1% Topical Capsaicin cream was appled to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467755|NCT00655811|P1|Participant Flow|Capsaicin and Placebo|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
468094|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
467756|NCT00655811|O2|Outcome|Placebo|"A placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467757|NCT00655811|O1|Outcome|Capsaicin|"0.1% Topical Capsaicin cream was applied to one forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467758|NCT00655811|O4|Outcome|Hispanics|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467867|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
469054|NCT00659490|E1|Reported Event|AZD1940|AZD1940 800ug given predose
467759|NCT00655811|O3|Outcome|East Asians|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467760|NCT00655811|O2|Outcome|Caucasians|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467761|NCT00655811|O1|Outcome|African Americans|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467762|NCT00655811|O4|Outcome|Hispanics|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467763|NCT00655811|O3|Outcome|East Asians|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467764|NCT00655811|O2|Outcome|Caucasians|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467765|NCT00655811|O1|Outcome|African Americans|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467766|NCT00655811|E2|Reported Event|Placebo|"A placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467767|NCT00655811|E1|Reported Event|Capsaicin|"0.1% Topical Capsaicin cream was applied to one forearm.
A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
467768|NCT00655824|B1|Baseline|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467849|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467850|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467851|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467957|NCT00656370|O2|Outcome|LR Infusion Group|Maximal post baseline increase in VAS score for LR infusions.
467769|NCT00655824|P1|Participant Flow|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course (TC). The remaining TCs were given at individualized time intervals when a clinical response had been achieved following the previous TC and a subsequent worsening in disease activity had been observed. For the remaining TCs, the interval between the TCs was at least 16 weeks from the first infusion in the previous TC irrespective of progression in disease activity. After each TC, participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next TC. A maximum of 9 TCs were allowed. After completing or withdrawing from the Treatment Period, participants were followed up every 12 weeks (for a maximum of 2 years in the Follow-up Period) until CD19+ cells returned to Baseline or normal levels.
467810|NCT00655824|E2|Reported Event|Ofatumumab 700 mg IV Infusion: Follow-up Period|After completing or withdrawing from the Treatment Period, participants were followed up every 12 weeks (for a maximum of 2 years in the Follow-up Period) until CD19+ cells returned to Baseline or normal levels.
469213|NCT00660075|E2|Reported Event|Placebo|Placebo for 6 weeks
467770|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467771|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467772|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467773|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467774|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467775|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467776|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467852|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467777|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467965|NCT00656448|O2|Outcome|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
467778|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467779|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467780|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467781|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467782|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467783|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467784|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467853|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467958|NCT00656370|O1|Outcome|NS Infusion Group|Maximal post baseline increase VAS score for NS infusion.
467785|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467786|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467787|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467788|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467789|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467790|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467791|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467792|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467854|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
468048|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate
Acamprosate: Total dose, 1998 mg daily, 1 week duration"
467793|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467794|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467795|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467796|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467797|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467798|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467799|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467800|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467855|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
468049|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
467801|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467802|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467803|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467804|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467805|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467806|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467807|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467808|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467856|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
468050|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone
Naltrexone: 50mg capsule, Once daily, 1 week duration"
467809|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467811|NCT00655824|E1|Reported Event|Ofatumumab 700 mg IV Infusion: Treatment Period|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treament course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
467812|NCT00655850|B1|Baseline|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:
Dexamethasone 20mg, intravenously (IV)
Diphenhydramine 50 mg IV
Ranitidine 50 mg IV
Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion
The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)
Paclitaxel Dose Levels:
Dose Level 1 ________80 mg/m2/weekly
Dose Level -1 _____"
467813|NCT00655850|P1|Participant Flow|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:
Dexamethasone 20mg, intravenously (IV)
Diphenhydramine 50 mg IV
Ranitidine 50 mg IV
Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion
The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)
Paclitaxel Dose Levels:
Dose Level 1 ________80 mg/m2/weekly
Dose Level -1 _____"
467814|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent
Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:
Dexamethasone 20mg, intravenously (IV)
Diphenhydramine 50 mg IV
Ranitidine 50 mg IV
Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion.
The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)
Paclitaxel Dose Levels:
Dose Level 1 ________80 mg/m2/weekly
Dose Level -1 _____"
467815|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent
Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:
Dexamethasone 20mg, intravenously (IV)
Diphenhydramine 50 mg IV
Ranitidine 50 mg IV
Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion.
The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)
Paclitaxel Dose Levels:
Dose Level 1 ________80 mg/m2/weekly
Dose Level -1 _____"
467816|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
467857|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467858|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467859|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467860|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467817|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:
Dexamethasone 20mg, intravenously (IV)
Diphenhydramine 50 mg IV
Ranitidine 50 mg IV
Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion
The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)
Paclitaxel Dose Levels:
Dose Level 1 ________80 mg/m2/weekly
Dose Level -1 _____"
467866|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
473936|NCT00669396|B2|Baseline|Levonorgestrel|Oral levonorgestrel
467818|NCT00655850|E1|Reported Event|Paclitaxel and Gemcitabine + Avastin|Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
467819|NCT00655863|B4|Baseline|Total|Total of all reporting groups
467820|NCT00655863|B3|Baseline|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467821|NCT00655863|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467822|NCT00655863|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467823|NCT00655863|P3|Participant Flow|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467824|NCT00655863|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467825|NCT00655863|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467826|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467827|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467828|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467829|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467830|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467831|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467832|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467833|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467834|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467835|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467836|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467837|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467838|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467839|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467840|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467841|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467842|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467843|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467844|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467845|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467846|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467847|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467848|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
468093|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
467861|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467862|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467863|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467864|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467865|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467868|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467869|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467870|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467871|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467872|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467873|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467874|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467875|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467876|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467877|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467878|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467879|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467880|NCT00655863|E3|Reported Event|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
467881|NCT00655863|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467882|NCT00655863|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
467883|NCT00655889|B1|Baseline|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
467884|NCT00655889|P1|Participant Flow|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
467885|NCT00655889|O1|Outcome|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
467886|NCT00655889|O1|Outcome|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
467887|NCT00655889|E1|Reported Event|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
467888|NCT00656058|B1|Baseline|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.
Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
467889|NCT00656058|P1|Participant Flow|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.
Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
467890|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.
Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
467891|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.
Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
467892|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.
Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
467893|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.
Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
467894|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.
Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
467895|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.
Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
467896|NCT00656058|E1|Reported Event|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.
Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
467897|NCT00656084|B1|Baseline|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
467898|NCT00656084|P1|Participant Flow|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
467899|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
467900|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
467901|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
473937|NCT00669396|B1|Baseline|Copper T380 IUD|IUD
467902|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
467903|NCT00656084|E1|Reported Event|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
467904|NCT00656136|B3|Baseline|Total|Total of all reporting groups
467905|NCT00656136|B2|Baseline|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
467906|NCT00656136|B1|Baseline|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
467907|NCT00656136|P2|Participant Flow|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus Best Supportive Care (BSC) or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
467908|NCT00656136|P1|Participant Flow|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
467909|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
467910|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
467911|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
467912|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
467913|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
467914|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
467915|NCT00656136|E2|Reported Event|Afatinib 50 mg/Day|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
467916|NCT00656136|E1|Reported Event|Placebo|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
467917|NCT00656175|B3|Baseline|Total|Total of all reporting groups
467918|NCT00656175|B2|Baseline|Delayed|Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
467919|NCT00656175|B1|Baseline|Immediate|Immediate switch of PI or NNRTI to Raltegravir
467920|NCT00656175|P2|Participant Flow|Delayed|Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir (400mg twice daily)
467921|NCT00656175|P1|Participant Flow|Immediate|Immediate switch of PI or NNRTI to Raltegravir (400 mg twice daily)
467922|NCT00656175|O2|Outcome|Delayed|Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir
467923|NCT00656175|O1|Outcome|Immediate|Immediate switch of PI or NNRTI to Raltegravir
467924|NCT00656175|E2|Reported Event|Delayed|Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
467925|NCT00656175|E1|Reported Event|Immediate|Immediate switch of PI or NNRTI to Raltegravir
467926|NCT00656201|B3|Baseline|Total|Total of all reporting groups
467927|NCT00656201|B2|Baseline|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
467928|NCT00656201|B1|Baseline|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
467929|NCT00656201|P2|Participant Flow|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
467930|NCT00656201|P1|Participant Flow|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
467931|NCT00656201|O2|Outcome|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
467932|NCT00656201|O1|Outcome|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
467933|NCT00656201|E2|Reported Event|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
468014|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
467934|NCT00656201|E1|Reported Event|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
467935|NCT00656292|B3|Baseline|Total|Total of all reporting groups
467936|NCT00656292|B2|Baseline|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467937|NCT00656292|B1|Baseline|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467938|NCT00656292|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467939|NCT00656292|P1|Participant Flow|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467940|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467941|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467942|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467943|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467956|NCT00656370|O1|Outcome|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
468150|NCT00649389|B5|Baseline|Total|Total of all reporting groups
467944|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467945|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467946|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467947|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467948|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467949|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467950|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467951|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467952|NCT00656292|E2|Reported Event|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467953|NCT00656292|E1|Reported Event|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
467954|NCT00656370|B1|Baseline|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
467955|NCT00656370|P1|Participant Flow|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
467959|NCT00656370|E1|Reported Event|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
467960|NCT00656448|B3|Baseline|Total|Total of all reporting groups
467961|NCT00656448|B2|Baseline|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
467962|NCT00656448|B1|Baseline|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
467963|NCT00656448|P2|Participant Flow|No Procrit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
467964|NCT00656448|P1|Participant Flow|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
467966|NCT00656448|O1|Outcome|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
467967|NCT00656448|O2|Outcome|No Procrit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
467968|NCT00656448|O1|Outcome|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
467969|NCT00656448|E2|Reported Event|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
467970|NCT00656448|E1|Reported Event|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
467971|NCT00656474|B1|Baseline|GLYC-101 and Placebo|Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.
467972|NCT00656474|P1|Participant Flow|GLYC-101 and Placebo|"Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.
GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation"
467973|NCT00656474|O2|Outcome|Placebo Retro-auricular Site (1 Per Participant)|Placebo gel Administration on Day 1, 3 and 5 post laser ablation
467974|NCT00656474|O1|Outcome|GLYC-101 Active Retro-auricular Site (1 Per Participant)|GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
467975|NCT00656474|O2|Outcome|Placebo Retro-auricular Site (1 Per Participant)|Placebo gel Administration on Day 1, 3 and 5 post laser ablation
467976|NCT00656474|O1|Outcome|GLYC-101 Active Retro-auricular Site (1 Per Participant)|GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
467977|NCT00656474|E1|Reported Event|GLYC-101 and Placebo|"Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.
GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation"
467978|NCT00656487|B4|Baseline|Total|Total of all reporting groups
467979|NCT00656487|B3|Baseline|Control|Participants were non-cannabis using controls.
467980|NCT00656487|B2|Baseline|Placebo|Participants were cannabis dependent and received matched placebo.
467981|NCT00656487|B1|Baseline|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
467982|NCT00656487|P3|Participant Flow|Control|Participants were non-cannabis using controls.
467983|NCT00656487|P2|Participant Flow|Placebo|Participants were cannabis dependent and received matched placebo.
467984|NCT00656487|P1|Participant Flow|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
467985|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
467986|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
467987|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
467988|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
467989|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
467990|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
467991|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
467992|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
467993|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
467994|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
467995|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
467996|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
467997|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
467998|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
467999|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
468000|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
468001|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
468002|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
468003|NCT00656487|E3|Reported Event|Control|Participants were non-cannabis using controls.
468004|NCT00656487|E2|Reported Event|Placebo|Participants were cannabis dependent and received matched placebo.
468204|NCT00649961|O1|Outcome|Single Arm|open label dose finding study
468005|NCT00656487|E1|Reported Event|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
468006|NCT00656513|B4|Baseline|Total|Total of all reporting groups
468007|NCT00656513|B3|Baseline|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468008|NCT00656513|B2|Baseline|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
468009|NCT00656513|B1|Baseline|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468010|NCT00656513|P3|Participant Flow|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468011|NCT00656513|P2|Participant Flow|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
468012|NCT00656513|P1|Participant Flow|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468013|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468015|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468016|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
468017|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468018|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
468019|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468020|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
468021|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468022|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
468023|NCT00656513|O1|Outcome|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468024|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468025|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
468026|NCT00656513|O1|Outcome|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468027|NCT00656513|E3|Reported Event|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468028|NCT00656513|E2|Reported Event|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
468029|NCT00656513|E1|Reported Event|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
468030|NCT00656617|B1|Baseline|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
468031|NCT00656617|P1|Participant Flow|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
468032|NCT00656617|O1|Outcome|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
468033|NCT00656617|O1|Outcome|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
468034|NCT00656617|E2|Reported Event|Idarubicin + Ara-C + Vorinostat (Phase 2)|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
468035|NCT00656617|E1|Reported Event|Idarubicin + Ara-C + Vorinostat (Phase 1)|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
468036|NCT00656630|B4|Baseline|Total|Total of all reporting groups
468037|NCT00656630|B3|Baseline|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
468038|NCT00656630|B2|Baseline|ReVia (Naltrexone)|"Naltrexone
Naltrexone: 50mg capsule, Once daily, 1 week duration"
468039|NCT00656630|B1|Baseline|Campral (Acamprosate)|"Acamprosate
Acamprosate: Total dose, 1998 mg daily, 1 week duration"
468040|NCT00656630|P3|Participant Flow|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
468041|NCT00656630|P2|Participant Flow|ReVia (Naltrexone)|"Naltrexone
Naltrexone: 50mg capsule, Once daily, 1 week duration"
468042|NCT00656630|P1|Participant Flow|Campral (Acamprosate)|"Acamprosate
Acamprosate: Total dose, 1998 mg daily, 1 week duration"
468043|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
468044|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone
Naltrexone: 50mg capsule, Once daily, 1 week duration"
468045|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate
Acamprosate: Total dose, 1998 mg daily, 1 week duration"
468046|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
468047|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone
Naltrexone: 50mg capsule, Once daily, 1 week duration"
469023|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
468051|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate
Acamprosate: Total dose, 1998 mg daily, 1 week duration"
468052|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
468053|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone
Naltrexone: 50mg capsule, Once daily, 1 week duration"
468054|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate
Acamprosate: Total dose, 1998 mg daily, 1 week duration"
468055|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
468056|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone
Naltrexone: 50mg capsule, Once daily, 1 week duration"
468057|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate
Acamprosate: Total dose, 1998 mg daily, 1 week duration"
468058|NCT00656630|E3|Reported Event|Placebo|Placebo: Double-dummy placebo capsules, 1 week duration
468059|NCT00656630|E2|Reported Event|Naltrexone|"Naltrexone
Naltrexone: 50mg capsule, Once daily, 1 week duration"
468060|NCT00656630|E1|Reported Event|Acamprosate|"Acamprosate
Acamprosate: Total dose, 1998 mg daily, 1 week duration"
468106|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468107|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468061|NCT00656656|B1|Baseline|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil
Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks
Rituximab: 1000 mg i.v. given twice at a 2-week interval
Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks
Azathioprine: 2.5 mg/kg body weight daily p.o.
Mycophenolate mofetil 2 g/d p.o."
468062|NCT00656656|P1|Participant Flow|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil
Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks
Rituximab: 1000 mg i.v. given twice at a 2-week interval
Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks
Azathioprine: 2.5 mg/kg body weight daily p.o.
Mycophenolate mofetil 2 g/d p.o."
468063|NCT00656656|O1|Outcome|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil
Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks
Rituximab: 1000 mg i.v. given twice at a 2-week interval
Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks
Azathioprine: 2.5 mg/kg body weight daily p.o.
Mycophenolate mofetil 2 g/d p.o."
468064|NCT00656656|O1|Outcome|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil
Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks
Rituximab: 1000 mg i.v. given twice at a 2-week interval
Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks
Azathioprine: 2.5 mg/kg body weight daily p.o.
Mycophenolate mofetil 2 g/d p.o."
468065|NCT00656656|E1|Reported Event|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil
Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks
Rituximab: 1000 mg i.v. given twice at a 2-week interval
Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks
Azathioprine: 2.5 mg/kg body weight daily p.o.
Mycophenolate mofetil 2 g/d p.o."
468066|NCT00656669|B1|Baseline|Overall Study|These patients are for the patients who were into the trial.
468067|NCT00656669|P1|Participant Flow|Segment Information|This is an exploratory phase 2 and biomarker clinical trial of sunitinib in the neoadjuvant setting for the treatment of breast cancer. The study will be conducted in 3 sequential treatment segments. During the first segment, patients will receive single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. Patients will then begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. Sunitinib will be discontinued after Cycle 5 Day 21. The third segment will include 4 cycles (8 weeks) of neoadjuvant treatment with AC followed by surgical resection and determination of pathological response.
468068|NCT00656669|O1|Outcome|Paclitaxel Plus Sunitinib|Patients who were in the paclitaxel plus sunitinib segment
468069|NCT00656669|O1|Outcome|AC Dosing|Patients who finished the AC dosing segment
468070|NCT00656669|O1|Outcome|Paclitaxel Plus Sunitinib|Patients who finished the paclitaxel plus sunitinib segment
468071|NCT00656669|O1|Outcome|Sunitinib Monotherapy|Patients who completed the Sunitinib monotherapy segment
468072|NCT00656669|E3|Reported Event|AC Dosing|4 cycles (8 weeks) of neoadjuvant treatment with AC.
468073|NCT00656669|E2|Reported Event|Paclitaxel/Sunitinib|4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.
468074|NCT00656669|E1|Reported Event|Single Agent Sunitinib|Single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation.
468075|NCT00656799|B1|Baseline|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468076|NCT00656799|P1|Participant Flow|Sugammadex|Intravenous (IV) single bolus dose of 4.0 mg/kg sugammadex
468077|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468078|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468079|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468080|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468081|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468082|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468083|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468084|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468085|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468086|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468087|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468088|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468089|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468090|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468091|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468092|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
469024|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
468095|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468096|NCT00656799|E1|Reported Event|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
468097|NCT00656851|B3|Baseline|Total|Total of all reporting groups
468098|NCT00656851|B2|Baseline|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468099|NCT00656851|B1|Baseline|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468100|NCT00656851|P2|Participant Flow|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468101|NCT00656851|P1|Participant Flow|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468102|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468103|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468104|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468105|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468108|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468109|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468110|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468111|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468112|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468113|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468114|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468115|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468116|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468117|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468118|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468119|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468120|NCT00656851|E2|Reported Event|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
468121|NCT00656851|E1|Reported Event|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
468122|NCT00648895|B3|Baseline|Total|Total of all reporting groups
468123|NCT00648895|B2|Baseline|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
468124|NCT00648895|B1|Baseline|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
468125|NCT00648895|P2|Participant Flow|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
468126|NCT00648895|P1|Participant Flow|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
468127|NCT00648895|O2|Outcome|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
468128|NCT00648895|O1|Outcome|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
468129|NCT00648895|E2|Reported Event|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
468130|NCT00648895|E1|Reported Event|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
468131|NCT00648908|B1|Baseline|Fampridine-SR|Tablets, 10mg twice daily
468132|NCT00648908|P1|Participant Flow|Fampridine-SR|Tablets, 10mg twice daily
468133|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
468134|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
468135|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
468136|NCT00648908|O1|Outcome|Fampridine-SR 10mg (Twice a Day)|
468137|NCT00648908|O1|Outcome|Fampridine-SR 10mg (Twice a Day)|
468138|NCT00648908|E1|Reported Event|Fampridine-SR|Tablets, 10mg twice daily
468139|NCT00649220|B1|Baseline|Memantine|Memantine tablets, twice a day (bid).
468140|NCT00649220|P1|Participant Flow|Memantine|Memantine tablets, twice a day (bid).
468141|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
468142|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
468143|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
468144|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
468145|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
468146|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
468147|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
468148|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
468149|NCT00649220|E1|Reported Event|Memantine|Memantine tablets, twice a day (bid).
468151|NCT00649389|B4|Baseline|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
468152|NCT00649389|B3|Baseline|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468153|NCT00649389|B2|Baseline|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468154|NCT00649389|B1|Baseline|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
468155|NCT00649389|P4|Participant Flow|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
468156|NCT00649389|P3|Participant Flow|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468157|NCT00649389|P2|Participant Flow|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468158|NCT00649389|P1|Participant Flow|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
468307|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
468159|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
468160|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468161|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468162|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
468163|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
468164|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468165|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468166|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
468167|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
468168|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468169|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468170|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
468171|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
468172|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468173|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468174|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
468175|NCT00649389|E4|Reported Event|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
468176|NCT00649389|E3|Reported Event|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468177|NCT00649389|E2|Reported Event|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
468178|NCT00649389|E1|Reported Event|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
468179|NCT00649428|B3|Baseline|Total|Total of all reporting groups
468180|NCT00649428|B2|Baseline|Placebo|Patients treated with placebo solution
468181|NCT00649428|B1|Baseline|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
468182|NCT00649428|P2|Participant Flow|Placebo|Patients treated with placebo solution
468183|NCT00649428|P1|Participant Flow|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
468184|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
468185|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
468186|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
468187|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
468188|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
468189|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
468190|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
468191|NCT00649428|O1|Outcome|Autologous Fibroblast|Patients treated with autologous fibroblasts (azficel-T).
468192|NCT00649428|E2|Reported Event|Placebo|Patients treated with placebo solution.
468193|NCT00649428|E1|Reported Event|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
468194|NCT00649792|B1|Baseline|Fampridine-SR|Tablets, 10 mg, BID
468195|NCT00649792|P1|Participant Flow|Fampridine-SR|Tablets, 10 mg, BID
468196|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
468197|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
468198|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
468199|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
468200|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
468201|NCT00649792|E1|Reported Event|Fampridine-SR|Tablets, 10 mg, BID
468202|NCT00649961|B1|Baseline|Single Arm|open label dose finding study
468203|NCT00649961|P1|Participant Flow|Melatonin Open Label Single Arm|Open label single arm study
468205|NCT00649961|E1|Reported Event|Single Arm|open label dose finding study
468206|NCT00650078|B3|Baseline|Total|Total of all reporting groups
468207|NCT00650078|B2|Baseline|Placebo|
468208|NCT00650078|B1|Baseline|NP01|Modified Release (MR) prednisone 5 mg
468209|NCT00650078|P2|Participant Flow|Placebo|
468210|NCT00650078|P1|Participant Flow|NP01|Modified Release (MR) prednisone 5 mg
468211|NCT00650078|O2|Outcome|Placebo|
468212|NCT00650078|O1|Outcome|NP01|Modified Release (MR) prednisone 5 mg
468213|NCT00650078|O2|Outcome|Placebo|
468214|NCT00650078|O1|Outcome|NP01|Modified Release (MR) prednisone 5 mg
468215|NCT00650078|E2|Reported Event|Placebo|
468216|NCT00650078|E1|Reported Event|NP01|Modified Release (MR) prednisone 5 mg
468217|NCT00650091|B3|Baseline|Total|Total of all reporting groups
468218|NCT00650091|B2|Baseline|Placebo|"Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day."
468219|NCT00650091|B1|Baseline|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
468220|NCT00650091|P3|Participant Flow|Pred/AZA/NAC|"The prednisone dose was started at 0.5 mg per kilo- gram of ideal body weight and was tapered to 0.15 mg per kilogram during a period of 25 weeks.
The azathioprine dose (maximum, 150 mg per day) was based on the patient’s ideal weight, concurrent use of allopurinol, and thiopurine methyl-transferase (TPMT) activity. NAC was prescribed at 600 mg orally three times a day."
468221|NCT00650091|P2|Participant Flow|Placebo|"Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day."
468222|NCT00650091|P1|Participant Flow|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
468223|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day."
468224|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
468225|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day."
468226|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
468227|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day."
468228|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
468229|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day."
468230|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
468231|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day."
468232|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
468233|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day."
468234|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
468235|NCT00650091|E4|Reported Event|Initial Study: Placebo|Placebo: Participants will receive placebo each day.
468236|NCT00650091|E3|Reported Event|Initial Study: Pred/AZA/NAC|Participants will receive prednisone, azathioprine, and N-acetylcysteine (NAC) for 60 weeks.
468237|NCT00650091|E2|Reported Event|Placebo|"Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day."
468238|NCT00650091|E1|Reported Event|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
468239|NCT00650104|B1|Baseline|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468240|NCT00650104|P1|Participant Flow|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468293|NCT00657020|P1|Participant Flow|4 mg Nicotine Lozenge Then Placebo Lozenge|Participants received nicotine lozenge containing 4 milligrams (mg) of nicotine in Period I and placebo lozenge in Period II.
468294|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
469025|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
468241|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468308|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
468309|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
468310|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention condition and received placebo lozenge.
468242|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468243|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468244|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468245|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468246|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468247|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468295|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
468296|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
468297|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
468298|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
469026|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
468248|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468249|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468250|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468251|NCT00650104|E1|Reported Event|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
468252|NCT00650260|B3|Baseline|Total|Total of all reporting groups
468253|NCT00650260|B2|Baseline|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468254|NCT00650260|B1|Baseline|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468255|NCT00650260|P2|Participant Flow|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468256|NCT00650260|P1|Participant Flow|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468299|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
468300|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
468301|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
468257|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468311|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention condition and received 4 mg of nicotine lozenge.
469214|NCT00660075|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
468258|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468259|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468260|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468261|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468262|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468263|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468264|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468265|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468302|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
468303|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
468304|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
468305|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
468306|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
468312|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention condition and received placebo lozenge.
468313|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention condition and received 4 mg of nicotine lozenge.
468314|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention condition and received placebo lozenge.
468315|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention condition and received 4 mg of nicotine lozenge.
468316|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention condition and received placebo lozenge.
468266|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468267|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468268|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468269|NCT00650260|E2|Reported Event|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468270|NCT00650260|E1|Reported Event|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
468271|NCT00656916|B3|Baseline|Total|Total of all reporting groups
468272|NCT00656916|B2|Baseline|Observation|Comparator group, no intervention.
468273|NCT00656916|B1|Baseline|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
468274|NCT00656916|P2|Participant Flow|Observation|Comparator group, no intervention.
468275|NCT00656916|P1|Participant Flow|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
468276|NCT00656916|O2|Outcome|Observation|Comparator group, no intervention.
468277|NCT00656916|O1|Outcome|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
468278|NCT00656916|E2|Reported Event|Observation|Comparator group, no intervention.
468279|NCT00656916|E1|Reported Event|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
468280|NCT00656968|B3|Baseline|Total|Total of all reporting groups
468281|NCT00656968|B2|Baseline|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
468282|NCT00656968|B1|Baseline|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
468283|NCT00656968|P2|Participant Flow|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
468284|NCT00656968|P1|Participant Flow|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
468285|NCT00656968|O2|Outcome|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
468286|NCT00656968|O1|Outcome|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
468287|NCT00656968|O2|Outcome|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
468288|NCT00656968|O1|Outcome|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
468289|NCT00656968|E2|Reported Event|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
468290|NCT00656968|E1|Reported Event|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
468291|NCT00657020|B1|Baseline|All Randomized Participants|All randomized participants who receive study treatments.
468292|NCT00657020|P2|Participant Flow|Placebo Lozenge Then 4 mg Nicotine Lozenge|Participants received placebo lozenge in Period I and nicotine 4 mg lozenge in Period II.
468317|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention condition and received 4 mg of nicotine lozenge.
468318|NCT00657020|E2|Reported Event|Placebo Lozenge|Participants in safety population received placebo lozenge.
468319|NCT00657020|E1|Reported Event|Nicotine Lozenge|Participants in safety population received 4 mg of nicotine lozenge.
468320|NCT00657046|B4|Baseline|Total|Total of all reporting groups
468321|NCT00657046|B3|Baseline|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468322|NCT00657046|B2|Baseline|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468323|NCT00657046|B1|Baseline|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468324|NCT00657046|P3|Participant Flow|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468325|NCT00657046|P2|Participant Flow|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468326|NCT00657046|P1|Participant Flow|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468327|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468328|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468329|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468330|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468331|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468332|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468333|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468334|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468335|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468336|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468337|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468338|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468339|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468340|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468341|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468342|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
469027|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
468343|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468344|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468345|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468346|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468347|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
469215|NCT00660179|B4|Baseline|Total|Total of all reporting groups
468348|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468349|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468350|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468351|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468352|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468353|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468354|NCT00657046|E3|Reported Event|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468355|NCT00657046|E2|Reported Event|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468356|NCT00657046|E1|Reported Event|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
468357|NCT00657150|B3|Baseline|Total|Total of all reporting groups
468358|NCT00657150|B2|Baseline|Enoxaparin|40mg qd (once daily) subcutaneous
468359|NCT00657150|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
468360|NCT00657150|P2|Participant Flow|Enoxaparin|40mg qd (once daily) subcutaneous
468361|NCT00657150|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
468362|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468363|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468364|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468365|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468366|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468367|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468368|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468369|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468370|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468371|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468372|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468373|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468374|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468375|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468376|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468377|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468378|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468379|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468380|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468381|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468382|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468383|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468384|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
468385|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
468386|NCT00657150|E2|Reported Event|Enoxaparin|40mg qd (once daily) subcutaneous
468387|NCT00657150|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
468388|NCT00658112|B1|Baseline|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.
Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
468457|NCT00658528|E2|Reported Event|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
469028|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
468389|NCT00658112|P1|Participant Flow|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.
Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
468431|NCT00658333|O1|Outcome|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
468502|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468390|NCT00658112|O1|Outcome|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.
Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
468391|NCT00658112|E1|Reported Event|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.
Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
468392|NCT00658138|B1|Baseline|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
468393|NCT00658138|P1|Participant Flow|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
468394|NCT00658138|O2|Outcome|Scotchbond 1XT|3M ESPE Adper Scotchbond 1XT
468395|NCT00658138|O1|Outcome|Scotchbond SE|3M ESPE Adper Scotchbond SE
468396|NCT00658138|E1|Reported Event|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
468397|NCT00658320|B3|Baseline|Total|Total of all reporting groups
468398|NCT00658320|B2|Baseline|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
468399|NCT00658320|B1|Baseline|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
468400|NCT00658320|P2|Participant Flow|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
468401|NCT00658320|P1|Participant Flow|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
468402|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
468403|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
468429|NCT00658333|O1|Outcome|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
468404|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
468503|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468405|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
468406|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
468407|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
468408|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
468409|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
468410|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
468411|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
468412|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
468413|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
468430|NCT00658333|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
468458|NCT00658528|E1|Reported Event|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
468932|NCT00659334|E5|Reported Event|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
468432|NCT00658333|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
468504|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468505|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468414|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
468415|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
468416|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
468417|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
468418|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
468419|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
468420|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
468421|NCT00658320|E2|Reported Event|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
468422|NCT00658320|E1|Reported Event|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
468423|NCT00658333|B3|Baseline|Total|Total of all reporting groups
468424|NCT00658333|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
468425|NCT00658333|B1|Baseline|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
468426|NCT00658333|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
468427|NCT00658333|P1|Participant Flow|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
468428|NCT00658333|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
468456|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
468654|NCT00658684|O1|Outcome|Total|All subjects
468433|NCT00658333|E1|Reported Event|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
468434|NCT00658385|B1|Baseline|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)
GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.
These will be done again 24 hours after your stem cells are collected."
468435|NCT00658385|P1|Participant Flow|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)
GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.
These will be done again 24 hours after your stem cells are collected."
468436|NCT00658385|O1|Outcome|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)
GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.
These will be done again 24 hours after your stem cells are collected."
468437|NCT00658385|E1|Reported Event|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)
GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.
These will be done again 24 hours after your stem cells are collected."
468438|NCT00658411|B1|Baseline|All Patients|Deferoxamine prior to stem cells
468439|NCT00658411|P1|Participant Flow|All Patients|Deferoxamine for >= 2 weeks prior to stem cells
468440|NCT00658411|O4|Outcome|Overall Survival (Deferoxamine)|Patients who received Deferoxamine and have relapsed and is alive at 1 year.
468441|NCT00658411|O3|Outcome|Disease-Free Survival (Deferoxamine)|Patients who received Deferoxamine and are currently alive without incidence of relapse at 1 year.
468442|NCT00658411|O2|Outcome|Relapse (Deferoxamine)|Patients who received Deferoxamine and relapsed post transplant at 1 year.
468443|NCT00658411|O1|Outcome|Transplant-Related Mortality (Deferoxamine)|Patients who received Deferoxamine and passed away as a result of transplant or study treatment without prior relapse at 1 year.
468444|NCT00658411|O1|Outcome|Deferoxamine|All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.
468445|NCT00658411|E1|Reported Event|Deferoxamine|All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.
468446|NCT00658528|B3|Baseline|Total|Total of all reporting groups
468447|NCT00658528|B2|Baseline|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
468448|NCT00658528|B1|Baseline|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
468449|NCT00658528|P2|Participant Flow|RAB ER 50 mg|Rabeprazole (RAB) Extended Release (ER) 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
468450|NCT00658528|P1|Participant Flow|ESO 40 mg|Esomeprazole (ESO) 40 mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50 mg capsule), once daily for 4 to 8 weeks.
468451|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
468452|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
468453|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
468454|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
468455|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
468459|NCT00658541|B1|Baseline|Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
468501|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468460|NCT00658541|P2|Participant Flow|Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets|On the morning of Day 1 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
468461|NCT00658541|P1|Participant Flow|Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets|On the morning of Day 1 following an an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received a single tablet of the reference formulation, Ambien® 10 mg.
468462|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
468463|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
468464|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
468465|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
468466|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
468467|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
468468|NCT00658541|E2|Reported Event|Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
468469|NCT00658541|E1|Reported Event|Zolpidem Tartrate 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
468470|NCT00658567|B4|Baseline|Total|Total of all reporting groups
468471|NCT00658567|B3|Baseline|20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
468472|NCT00658567|B2|Baseline|10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
468473|NCT00658567|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
468474|NCT00658567|P3|Participant Flow|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
468475|NCT00658567|P2|Participant Flow|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
468476|NCT00658567|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
468477|NCT00658567|O3|Outcome|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
468478|NCT00658567|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
468479|NCT00658567|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
468480|NCT00658567|O3|Outcome|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
468481|NCT00658567|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
468482|NCT00658567|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
468483|NCT00658567|E3|Reported Event|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
468484|NCT00658567|E2|Reported Event|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
468485|NCT00658567|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
468486|NCT00658606|B3|Baseline|Total|Total of all reporting groups
468487|NCT00658606|B2|Baseline|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468488|NCT00658606|B1|Baseline|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468489|NCT00658606|P2|Participant Flow|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468490|NCT00658606|P1|Participant Flow|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468491|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468492|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468493|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468494|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468495|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468496|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468497|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468498|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468499|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468500|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
473938|NCT00669396|P2|Participant Flow|Levonorgestrel|Oral levonorgestrel
468506|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468507|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468508|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468509|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468510|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468511|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468512|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468513|NCT00658606|E2|Reported Event|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
468514|NCT00658606|E1|Reported Event|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
468515|NCT00658619|B6|Baseline|Total|Total of all reporting groups
468516|NCT00658619|B5|Baseline|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
468517|NCT00658619|B4|Baseline|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468518|NCT00658619|B3|Baseline|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468519|NCT00658619|B2|Baseline|200 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468520|NCT00658619|B1|Baseline|400 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468521|NCT00658619|P5|Participant Flow|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
468522|NCT00658619|P4|Participant Flow|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468523|NCT00658619|P3|Participant Flow|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468524|NCT00658619|P2|Participant Flow|200 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468525|NCT00658619|P1|Participant Flow|400 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468526|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
468527|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
468528|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468529|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
468530|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
468531|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468532|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
468533|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
468534|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468535|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
468536|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
468537|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468538|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
468539|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468540|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468541|NCT00658619|E3|Reported Event|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
468542|NCT00658619|E2|Reported Event|200 µg Brimonidine Tartrate Implant|Stage 1 and 2 combined: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
469029|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
468543|NCT00658619|E1|Reported Event|400 µg Brimonidine Tartrate Implant|Stage 1 and 2 combined: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
468544|NCT00658632|B3|Baseline|Total|Total of all reporting groups
468545|NCT00658632|B2|Baseline|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
468546|NCT00658632|B1|Baseline|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
468547|NCT00658632|P2|Participant Flow|Rabeprazole (RAB) Extended Release (ER) 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
468548|NCT00658632|P1|Participant Flow|Esomeprazole (ESO) 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
468549|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
468550|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
468551|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
468552|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
468553|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
468554|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
468555|NCT00658632|E2|Reported Event|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
468556|NCT00658632|E1|Reported Event|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
468557|NCT00658658|B6|Baseline|Total|Total of all reporting groups
468558|NCT00658658|B5|Baseline|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468559|NCT00658658|B4|Baseline|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468560|NCT00658658|B3|Baseline|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468561|NCT00658658|B2|Baseline|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468562|NCT00658658|B1|Baseline|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468563|NCT00658658|P5|Participant Flow|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468564|NCT00658658|P4|Participant Flow|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468565|NCT00658658|P3|Participant Flow|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468566|NCT00658658|P2|Participant Flow|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468567|NCT00658658|P1|Participant Flow|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468568|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468569|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468570|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468571|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468657|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468572|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468573|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468574|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
469216|NCT00660179|B3|Baseline|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
468575|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468576|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468577|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468578|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468579|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468580|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468581|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468582|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468583|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468584|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468585|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468586|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468587|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468588|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468589|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468590|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468591|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468592|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468593|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468655|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468594|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468595|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468596|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468597|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468598|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468599|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468600|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468601|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468602|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468603|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468604|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468605|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468606|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468607|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468608|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468609|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468610|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468611|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468612|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468613|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468614|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468615|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468656|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468616|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468617|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468618|NCT00658658|E5|Reported Event|Age 1-11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468619|NCT00658658|E4|Reported Event|Age 1-11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468620|NCT00658658|E3|Reported Event|Age 12-17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468621|NCT00658658|E2|Reported Event|Age 12-17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468622|NCT00658658|E1|Reported Event|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
468623|NCT00658684|B4|Baseline|Total|Total of all reporting groups
468624|NCT00658684|B3|Baseline|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468625|NCT00658684|B2|Baseline|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468626|NCT00658684|B1|Baseline|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468627|NCT00658684|P4|Participant Flow|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468628|NCT00658684|P3|Participant Flow|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468629|NCT00658684|P2|Participant Flow|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468630|NCT00658684|P1|Participant Flow|Total|All subjects
468631|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468632|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468633|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468634|NCT00658684|O1|Outcome|Total|All subjects
468635|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468636|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468637|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468638|NCT00658684|O1|Outcome|Total|All subjects
468639|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468640|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468641|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468642|NCT00658684|O1|Outcome|Total|All subjects
468643|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468644|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468645|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468646|NCT00658684|O1|Outcome|Total|All subjects
468647|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468648|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468649|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468650|NCT00658684|O1|Outcome|Total|All subjects
468651|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468652|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468653|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468659|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468660|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468661|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468662|NCT00658684|O1|Outcome|Total|All subjects
468663|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468664|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468665|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468666|NCT00658684|O1|Outcome|Total|All subjects
468667|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468668|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468669|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468670|NCT00658684|O1|Outcome|Total|All subjects
468671|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468672|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468673|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468674|NCT00658684|O1|Outcome|Total|All subjects
468675|NCT00658684|E4|Reported Event|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
468676|NCT00658684|E3|Reported Event|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
468677|NCT00658684|E2|Reported Event|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
468678|NCT00658684|E1|Reported Event|Total|All subjects
468679|NCT00658697|B1|Baseline|Docetaxel, Bevacizumab, and Androgen Deprivation Therapy (ADT)|"Docetaxel:
Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab:
Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
Androgen deprivation therapy (ADT) or Luteinizing hormone-releasing hormone agonist (LHRH):
Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide:
Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)
Docetaxel
Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
468680|NCT00658697|P1|Participant Flow|Docetaxel, Bevacizumab, and ADT|"Docetaxel:
Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab:
Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT or Luteinizing hormone-releasing hormone agonist (LHRH):
Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide:
Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)
Docetaxel
Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
468681|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)
Docetaxel
Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
468682|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide:
Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)
Docetaxel
Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
468683|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:
Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab:
Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT or Luteinizing hormone-releasing hormone agonist (LHRH):
Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide:
Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)
Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
468933|NCT00659334|E4|Reported Event|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
468684|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:
Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab:
Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT or Luteinizing hormone-releasing hormone agonist (LHRH):
Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide:
Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)
Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
468752|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468685|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:
Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab:
Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT or Luteinizing hormone-releasing hormone agonist (LHRH):
Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide:
Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)
Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
468686|NCT00658697|E1|Reported Event|Docetaxel, Bevacizumab, and ADT|"Docetaxel:
Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab:
Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT or Luteinizing hormone-releasing hormone agonist (LHRH):
Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide:
Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)
Docetaxel
Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
468687|NCT00658723|B3|Baseline|Total|Total of all reporting groups
468688|NCT00658723|B2|Baseline|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
468689|NCT00658723|B1|Baseline|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
468690|NCT00658723|P3|Participant Flow|Fibrin Pad Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). (Non - Randomized)
468691|NCT00658723|P2|Participant Flow|SURGICEL™ Randomized|"SURGICEL™ Absorbable Hemostat
SURGICEL™: Absorbable hemostat"
468692|NCT00658723|P1|Participant Flow|Fibrin Pad Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
468693|NCT00658723|O2|Outcome|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
468694|NCT00658723|O1|Outcome|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
468695|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
468696|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
468697|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
468698|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
468699|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
468700|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
468701|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
468702|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
468703|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
468704|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
468705|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
468706|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
468707|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
468708|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
468709|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
468710|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
468711|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
468712|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
468753|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468713|NCT00658723|O3|Outcome|Fibrin Pad - Non-Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
468714|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
468715|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
468716|NCT00658723|E2|Reported Event|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
468717|NCT00658723|E1|Reported Event|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
468718|NCT00658736|B3|Baseline|Total|Total of all reporting groups
468719|NCT00658736|B2|Baseline|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only
Bupivicaine alone"
468720|NCT00658736|B1|Baseline|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone
Triamcinolone"
468721|NCT00658736|P2|Participant Flow|Bupivicaine Plus Triamcinolone|EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution mixed with 80 mg Triamcinolone.
468722|NCT00658736|P1|Participant Flow|Bupivicaine Alone|EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution.
468723|NCT00658736|O2|Outcome|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only
Bupivicaine alone"
468724|NCT00658736|O1|Outcome|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone
Triamcinolone"
468725|NCT00658736|O2|Outcome|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only
Bupivicaine alone"
468726|NCT00658736|O1|Outcome|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone
Triamcinolone"
468727|NCT00658736|E2|Reported Event|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only
Bupivicaine alone"
468728|NCT00658736|E1|Reported Event|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone
Triamcinolone"
468729|NCT00658775|B3|Baseline|Total|Total of all reporting groups
468730|NCT00658775|B2|Baseline|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
468731|NCT00658775|B1|Baseline|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
468732|NCT00658775|P2|Participant Flow|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
468733|NCT00658775|P1|Participant Flow|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
468734|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
468735|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
468736|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
468737|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
468738|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
468739|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
468740|NCT00658775|E2|Reported Event|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
468741|NCT00658775|E1|Reported Event|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
468742|NCT00658788|B1|Baseline|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
468743|NCT00658788|P1|Participant Flow|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
468744|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468745|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468746|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468747|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468748|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
469030|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
468749|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468750|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468751|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
473939|NCT00669396|P1|Participant Flow|Copper T380 IUD|IUD
468754|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468755|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468756|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468757|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468758|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468759|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468760|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468761|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468762|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468763|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468764|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468765|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468766|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468767|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468768|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468769|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468770|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468771|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468772|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468773|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468774|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468775|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468776|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468777|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468778|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468779|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468780|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468781|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468782|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468783|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468784|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468785|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468786|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
469031|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
468787|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468788|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468789|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468790|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468791|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468792|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
468793|NCT00658788|O1|Outcome|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
468794|NCT00658788|E1|Reported Event|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
468795|NCT00658814|B3|Baseline|Total|Total of all reporting groups
468796|NCT00658814|B2|Baseline|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
468797|NCT00658814|B1|Baseline|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
468798|NCT00658814|P2|Participant Flow|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Patients in continued remission may go on to receive maintenance therapy.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
468799|NCT00658814|P1|Participant Flow|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Patients in continued remission may go on to receive maintenance therapy.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
468800|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
468801|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
468802|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
468803|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
468804|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
468841|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468805|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
468806|NCT00658814|O3|Outcome|Maintenance Therapy|Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
468807|NCT00658814|O2|Outcome|Consolidation Therapy|Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
468935|NCT00659334|E2|Reported Event|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
468808|NCT00658814|O1|Outcome|Remission Induction Chemotherapy|Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
468809|NCT00658814|E3|Reported Event|Maintenance Therapy|Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
468810|NCT00658814|E2|Reported Event|Consolidation Therapy|Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
468811|NCT00658814|E1|Reported Event|Remission Induction Chemotherapy|Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
468812|NCT00658996|B1|Baseline|Entire Study Population|Population enrolled at start of study
468813|NCT00658996|P2|Participant Flow|Focus Dailies Toric First, Then SofLens DD Toric|Ciba Vision Focus Dailies Toric Lens first, then crossover to Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
468814|NCT00658996|P1|Participant Flow|SofLens DD Toric First, Then Focus Dailies Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens first then crossover to Ciba Vision Focus Dailies Toric Lens
468815|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
468816|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
468817|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
468818|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
468819|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
468820|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
468821|NCT00658996|E2|Reported Event|Ciba Vision Toric Lens|Ciba Vision Focus Dailies Toric Lens
468822|NCT00658996|E1|Reported Event|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
468823|NCT00659061|B3|Baseline|Total|Total of all reporting groups
468824|NCT00659061|B2|Baseline|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468825|NCT00659061|B1|Baseline|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468826|NCT00659061|P2|Participant Flow|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468827|NCT00659061|P1|Participant Flow|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468828|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468829|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468830|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468831|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468832|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468833|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468834|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468835|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468836|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468837|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468838|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468839|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468840|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468842|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468843|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
468844|NCT00659165|B3|Baseline|Total|Total of all reporting groups
468845|NCT00659165|B2|Baseline|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
468846|NCT00659165|B1|Baseline|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
468847|NCT00659165|P2|Participant Flow|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
468848|NCT00659165|P1|Participant Flow|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
468849|NCT00659165|O2|Outcome|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
468850|NCT00659165|O1|Outcome|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
468851|NCT00659165|E2|Reported Event|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
468852|NCT00659165|E1|Reported Event|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
468853|NCT00659230|B3|Baseline|Total|Total of all reporting groups
468854|NCT00659230|B2|Baseline|Nepicastat|"Arm 2
Nepicastat: 100-800mg"
468855|NCT00659230|B1|Baseline|Placebo|"Arm 1
Placebo: 100-800mg placebo"
468856|NCT00659230|P2|Participant Flow|Nepicastat|"Arm 2
Nepicastat: 100-800mg"
468857|NCT00659230|P1|Participant Flow|Placebo|"Arm 1
Placebo: 100-800mg placebo"
468858|NCT00659230|O2|Outcome|Nepicastat|"Arm 2
Nepicastat: 100-800mg"
468859|NCT00659230|O1|Outcome|Placebo|"Arm 1
Placebo: 100-800mg placebo"
468860|NCT00659230|O2|Outcome|Nepicastat|"Arm 2
Nepicastat: 100-800mg"
468861|NCT00659230|O1|Outcome|Placebo|"Arm 1
Placebo: 100-800mg placebo"
468862|NCT00659230|O2|Outcome|Nepicastat|"Arm 2
Nepicastat: 100-800mg"
468863|NCT00659230|O1|Outcome|Placebo|"Arm 1
Placebo: 100-800mg placebo"
468864|NCT00659230|O2|Outcome|Nepicastat|"Arm 2
Nepicastat: 100-800mg"
468865|NCT00659230|O1|Outcome|Placebo|"Arm 1
Placebo: 100-800mg placebo"
468866|NCT00659230|E2|Reported Event|Nepicastat|"Arm 2
Nepicastat: 100-800mg"
468867|NCT00659230|E1|Reported Event|Placebo|"Arm 1
Placebo: 100-800mg placebo"
468868|NCT00659269|B3|Baseline|Total|Total of all reporting groups
468869|NCT00659269|B2|Baseline|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Cumulative doses (in mg/m2) are:
paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
468870|NCT00659269|B1|Baseline|Multivitamin (MV)|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
468871|NCT00659269|P2|Participant Flow|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Cumulative doses (in mg/m2) are:
paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
468872|NCT00659269|P1|Participant Flow|Multivitamin (MV)|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
468873|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
vincristine, 8-16; vinorelbine, 360-480"
468934|NCT00659334|E3|Reported Event|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
468874|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Ranges of cumulative doses (in mg/m2) are:
vincristine, 8-16; vinorelbine, 360-480"
468936|NCT00659334|E1|Reported Event|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
469217|NCT00660179|B2|Baseline|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
468875|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
cisplatin, 240-400; oxaliplatin, 400-800"
468876|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Ranges of cumulative doses (in mg/m2) are:
cisplatin, 240-400; oxaliplatin, 400-800"
468877|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
468878|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Ranges of cumulative doses (in mg/m2) are:
paclitaxel, 700-960; docetaxel, abraxane, 1200-1800"
468879|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
vincristine, 8-16; vinorelbine, 360-480"
468880|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Ranges of cumulative doses (in mg/m2) are:
vincristine, 8-16; vinorelbine, 360-480"
468881|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
cisplatin, 240-400; oxaliplatin, 400-800"
468882|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Ranges of cumulative doses (in mg/m2) are:
cisplatin, 240-400; oxaliplatin, 400-800"
468883|NCT00659269|O2|Outcome|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
468884|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Ranges of cumulative doses (in mg/m2) are:
paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
468930|NCT00659334|E7|Reported Event|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
468931|NCT00659334|E6|Reported Event|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
468937|NCT00659360|B1|Baseline|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally"
468938|NCT00659360|P1|Participant Flow|Arm I AZD0530|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally"
469218|NCT00660179|B1|Baseline|Placebo|Matching ACT-064992 placebo tablet, once daily
468885|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
vincristine, 8-16; vinorelbine, 360-480"
468886|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Ranges of cumulative doses (in mg/m2) are:
vincristine, 8-16; vinorelbine, 360-480"
468887|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
cisplatin, 240-400; oxaliplatin, 400-800"
468888|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Ranges of cumulative doses (in mg/m2) are:
cisplatin, 240-400; oxaliplatin, 400-800"
468889|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
468890|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Ranges of cumulative doses (in mg/m2) are:
paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
468891|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
vincristine, 8-16; vinorelbine, 360-480"
468892|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Cumulative doses for chemotherapy (in mg/m2) are:
vincristine, 8-16; vinorelbine, 360-480"
468893|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
cisplatin, 240-400; oxaliplatin, 400-800"
468894|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Cumulative doses for chemotherapy (in mg/m2) are:
cisplatin, 240-400; oxaliplatin, 400-800"
468895|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Ranges of cumulative doses (in mg/m2) are:
paclitaxel, 700-960; docetaxel, 240-400"
468896|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Ranges of cumulative doses (in mg/m2) are:
paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
468897|NCT00659269|E2|Reported Event|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections
Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).
The patient will also take the following, starting on the first day of chemotherapy:
pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
Cumulative doses (in mg/m2) are:
paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
468898|NCT00659269|E1|Reported Event|Multivitamin (MV)|"Multivitamin only
Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
468899|NCT00659295|B3|Baseline|Total|Total of all reporting groups
468900|NCT00659295|B2|Baseline|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
468901|NCT00659295|B1|Baseline|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
468902|NCT00659295|P2|Participant Flow|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
468903|NCT00659295|P1|Participant Flow|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
468904|NCT00659295|O2|Outcome|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
468905|NCT00659295|O1|Outcome|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
468906|NCT00659295|E2|Reported Event|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
468907|NCT00659295|E1|Reported Event|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
468908|NCT00659334|B8|Baseline|Total|Total of all reporting groups
468909|NCT00659334|B7|Baseline|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
468910|NCT00659334|B6|Baseline|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
468911|NCT00659334|B5|Baseline|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
468912|NCT00659334|B4|Baseline|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
468913|NCT00659334|B3|Baseline|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
468914|NCT00659334|B2|Baseline|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
468915|NCT00659334|B1|Baseline|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
468916|NCT00659334|P7|Participant Flow|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
468917|NCT00659334|P6|Participant Flow|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
468918|NCT00659334|P5|Participant Flow|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
468919|NCT00659334|P4|Participant Flow|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
468920|NCT00659334|P3|Participant Flow|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
468921|NCT00659334|P2|Participant Flow|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
468922|NCT00659334|P1|Participant Flow|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
468923|NCT00659334|O7|Outcome|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
468924|NCT00659334|O6|Outcome|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
468925|NCT00659334|O5|Outcome|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
468926|NCT00659334|O4|Outcome|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
468927|NCT00659334|O3|Outcome|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
468928|NCT00659334|O2|Outcome|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
468929|NCT00659334|O1|Outcome|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
468939|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally"
468940|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally"
468941|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally"
468942|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally"
468943|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally"
468944|NCT00659360|E1|Reported Event|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally"
468945|NCT00659373|B3|Baseline|Total|Total of all reporting groups
468946|NCT00659373|B2|Baseline|Ovarian Function Suppression|"Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation).
Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS."
468947|NCT00659373|B1|Baseline|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
468948|NCT00659373|P2|Participant Flow|Ovarian Function Suppression|Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
468949|NCT00659373|P1|Participant Flow|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
468950|NCT00659373|O2|Outcome|Ovarian Function Suppression|"Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS."
468951|NCT00659373|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
468952|NCT00659373|E2|Reported Event|Ovarian Function Suppression|Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
468953|NCT00659373|E1|Reported Event|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
468954|NCT00659438|B3|Baseline|Total|Total of all reporting groups
468955|NCT00659438|B2|Baseline|Placebo|Bicalutamide 150mg + placebo
468956|NCT00659438|B1|Baseline|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468957|NCT00659438|P2|Participant Flow|Placebo|Bicalutamide 150mg + placebo
468958|NCT00659438|P1|Participant Flow|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468959|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
468960|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468961|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
468962|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468963|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
468964|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468965|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
468966|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468967|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
468968|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468969|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
468970|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468971|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
468972|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468973|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
468974|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468975|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
468976|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468977|NCT00659438|E2|Reported Event|Placebo|Bicalutamide 150mg + placebo
468978|NCT00659438|E1|Reported Event|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
468979|NCT00659490|B4|Baseline|Total|Total of all reporting groups
468980|NCT00659490|B3|Baseline|Naproxen|Naproxen 500mg given pre-surgery
468981|NCT00659490|B2|Baseline|Placebo|Placebo given pre-surgery
468982|NCT00659490|B1|Baseline|AZD1940|AZD1940 800ug given predose
468983|NCT00659490|P3|Participant Flow|Naproxen|Naproxen 500mg given pre-surgery
468984|NCT00659490|P2|Participant Flow|Placebo|Placebo given pre-surgery
468985|NCT00659490|P1|Participant Flow|AZD1940|AZD1940 800ug given predose
468986|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
468987|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
468988|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
469032|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
469033|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
469034|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
469035|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
469036|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
469037|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
469038|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
469039|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
469055|NCT00659529|B1|Baseline|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.
sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
469056|NCT00659529|P1|Participant Flow|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.
sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
469057|NCT00659529|O1|Outcome|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.
sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
469058|NCT00659529|E1|Reported Event|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.
sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
469059|NCT00659581|B1|Baseline|Telmisartan|
469060|NCT00659581|P1|Participant Flow|Telmisartan|
469061|NCT00659581|O1|Outcome|Telmisartan|
469062|NCT00659581|O1|Outcome|Telmisartan|
469063|NCT00659581|O1|Outcome|Telmisartan|
469064|NCT00659581|O1|Outcome|Telmisartan|
469065|NCT00659581|O1|Outcome|Telmisartan|
469066|NCT00659581|O1|Outcome|Telmisartan|
469067|NCT00659581|O1|Outcome|Telmisartan|
469068|NCT00659581|O1|Outcome|Telmisartan|
469069|NCT00659581|O1|Outcome|Telmisartan|
469070|NCT00659581|E1|Reported Event|Telmisartan|
469071|NCT00659607|B1|Baseline|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
469072|NCT00659607|P1|Participant Flow|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
469073|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3932/ The number of patients for efficacy assessment: 3616.
469074|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3932/ The number of patients for efficacy assessment: 3616.
469075|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
469076|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
469077|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
469078|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
469079|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
469080|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
469081|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
469082|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
469083|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
469084|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
469085|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
469086|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
469087|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
469088|NCT00659607|E1|Reported Event|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
473940|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
469089|NCT00659633|B1|Baseline|Lidocaine|"Intravenous lidocaine for neuropathic pain
lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
469090|NCT00659633|P1|Participant Flow|Lidocaine|"Intravenous lidocaine for neuropathic pain
lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
469091|NCT00659633|O1|Outcome|Lidocaine|"Intravenous lidocaine for neuropathic pain
lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
469092|NCT00659633|E1|Reported Event|Lidocaine|"Intravenous lidocaine for neuropathic pain
lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
469093|NCT00659724|B1|Baseline|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
469094|NCT00659724|P1|Participant Flow|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
469095|NCT00659724|O3|Outcome|Optiflux F200NR|
469096|NCT00659724|O2|Outcome|Optiflux F180NR|
469097|NCT00659724|O1|Outcome|Revaclear MAX|
469098|NCT00659724|O3|Outcome|Optiflux F200NR|
469099|NCT00659724|O2|Outcome|Optiflux F180NR|
469100|NCT00659724|O1|Outcome|Revaclear MAX|
469101|NCT00659724|O3|Outcome|Optiflux F200NR|
469102|NCT00659724|O2|Outcome|Optiflux F180NR|
469103|NCT00659724|O1|Outcome|Revaclear MAX|
469104|NCT00659724|O3|Outcome|Optiflux F200NR|
469105|NCT00659724|O2|Outcome|Optiflux F180NR|
469106|NCT00659724|O1|Outcome|Revaclear MAX|
469107|NCT00659724|O3|Outcome|Optiflux F200NR|
469108|NCT00659724|O2|Outcome|Optiflux F180NR|
469109|NCT00659724|O1|Outcome|Revaclear MAX|
469110|NCT00659724|E1|Reported Event|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
469111|NCT00659737|B3|Baseline|Total|Total of all reporting groups
469112|NCT00659737|B2|Baseline|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
469113|NCT00659737|B1|Baseline|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
469114|NCT00659737|P2|Participant Flow|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure.
469115|NCT00659737|P1|Participant Flow|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
469116|NCT00659737|O2|Outcome|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
469117|NCT00659737|O1|Outcome|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
469118|NCT00659737|E2|Reported Event|Scopolamine|"Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.
Scopolamine + Emend (Aprepitant): 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days"
469119|NCT00659737|E1|Reported Event|Aprepiatnt|"Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.
Emend (Aprepitant) + Placebo: 40mg tablet"
469120|NCT00659789|B3|Baseline|Total|Total of all reporting groups
469121|NCT00659789|B2|Baseline|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
469122|NCT00659789|B1|Baseline|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
469123|NCT00659789|P2|Participant Flow|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
469124|NCT00659789|P1|Participant Flow|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
469125|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
469269|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469840|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
469126|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
469127|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
469128|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
469129|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
469130|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
469131|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
469132|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
469133|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
469134|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
469135|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
469136|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
469137|NCT00659789|E2|Reported Event|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
469138|NCT00659789|E1|Reported Event|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
469139|NCT00659815|B3|Baseline|Total|Total of all reporting groups
469140|NCT00659815|B2|Baseline|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
469141|NCT00659815|B1|Baseline|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
469142|NCT00659815|P2|Participant Flow|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
469143|NCT00659815|P1|Participant Flow|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
469144|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
469145|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
469146|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
469147|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
469148|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
469149|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
469150|NCT00659815|E2|Reported Event|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
469151|NCT00659815|E1|Reported Event|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
469152|NCT00659880|B1|Baseline|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
469153|NCT00659880|P1|Participant Flow|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
469154|NCT00659880|O1|Outcome|Meniscal Allograft Integration|The MRI were assessed for the integration of the posterior and anterior horns as well as the body of the meniscus.
469155|NCT00659880|O1|Outcome|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
469156|NCT00659880|E1|Reported Event|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
469157|NCT00659945|B3|Baseline|Total|Total of all reporting groups
469158|NCT00659945|B2|Baseline|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
469159|NCT00659945|B1|Baseline|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
469160|NCT00659945|P2|Participant Flow|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
469161|NCT00659945|P1|Participant Flow|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
469162|NCT00659945|O2|Outcome|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
469163|NCT00659945|O1|Outcome|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
469164|NCT00659945|E2|Reported Event|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
469165|NCT00659945|E1|Reported Event|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
469166|NCT00659984|B1|Baseline|Ultratrace™ Iobenguane I 131|Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. Therapeutic dosing began at 12.0 mCi/kg and escalated to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes.
469167|NCT00659984|P1|Participant Flow|Ultratrace™ Iobenguane I 131|"Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 within 7 days (d) of enrollment, followed by 3 dosimetry scans over 3-6 days. For the imaging dose, 0.1 mCi/kg (3.7 MBq/kg), at a min dose of 1 mCi (37 MBq) but not to exceed 5 mCi (185 MBq) of Ultratrace™ Iobenguane I 131 was administered 7-28 d prior to the therapeutic dose on Day 0. If the imaging dose demonstrated NL biodistribution/tumor uptake, pts received a therapeutic dose within 7-28 d of the imaging dose followed by a single imaging scan on Day 7 post therapy.
Therapeutic dosing was to begin at 12.0 mCi/kg and escalate to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. Based on actual doses administered, pts were grouped into 3 mean dose groups: 11.2, 15.5, and 18.2 mCi/kg.
The dosimetry dose was administered over 1-3 mins by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused over 30 to 60 mins."
469219|NCT00660179|P3|Participant Flow|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
469168|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|Based on the actual doses administered, patients were grouped into 3 dose groups of 6, 3, and 6 patients, according to the mean doses of the groups, which were 11.2, 15.5, and 18.2 mCi/kg, respectively.
469169|NCT00659984|O1|Outcome|Over Tumor Response|The proportion of patients who were considered successful defined as a patient achieving a Complete Response, Very Good Partial Response or Partial Response as determined by the Independent Reviewers.
469170|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|The proportion of patients who were considered successful defined as a patient achieving a Complete Response, Very Good Partial Response or Partial Response as determined by the Independent Reviewers.
469171|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|Following therapeutic dosing at the 12.0, 15.0, and 18.0 mCi/kg cohorts, 4 patients who were to receive the 21.0 mCi/kg therapeutic dose were required to have their planned dose reduced below the dose that was calculated based on the patient’s dosimetry results, in order to meet the protocol guidelines for maximal dosage allowed to normal organs described above. Because of the differences between the planned and actual therapeutic doses that were administered to several patients, patients were grouped and the study data were presented and analyzed by actual doses rather than by the planned dose cohorts of 12.0, 15.0, 18.0, and 21.0 mCi/kg. Based on the actual doses administered, patients were grouped into 3 dose groups of 6, 3, and 6 patients, according to the mean doses of the groups, which were 11.2, 15.5, and 18.2 mCi/kg, respectively.
469172|NCT00659984|O3|Outcome|18.2 mCi Group|18.2 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
469173|NCT00659984|O2|Outcome|15.5 mCi Group|15.5 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
469174|NCT00659984|O1|Outcome|11.2 mCi Group|11.2 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
469175|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|Following therapeutic dosing at the 12.0, 15.0, and 18.0 mCi/kg cohorts, 4 patients who were to receive the 21.0 mCi/kg therapeutic dose were required to have their planned dose reduced below the dose that was calculated based on the patient’s dosimetry results, in order to meet the protocol guidelines for maximal dosage allowed to normal organs described above. Because of the differences between the planned and actual therapeutic doses that were administered to several patients, patients were grouped and the study data were presented and analyzed by actual doses rather than by the planned dose cohorts of 12.0, 15.0, 18.0, and 21.0 mCi/kg. Based on the actual doses administered, patients were grouped into 3 dose groups of 6, 3, and 6 patients, according to the mean doses of the groups, which were 11.2, 15.5, and 18.2 mCi/kg, respectively.
469176|NCT00659984|E1|Reported Event|Ultratrace™ Iobenguane I 131|Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. Mean therapeutic dosing groups were 11.2 mCi/kg, 15.5 nCi/kg and 18.2 mCi/kg. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes.
469177|NCT00660010|B1|Baseline|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469178|NCT00660010|P1|Participant Flow|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469179|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469180|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469181|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469182|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469183|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469184|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469185|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469186|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469187|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469188|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469189|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469220|NCT00660179|P2|Participant Flow|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
469190|NCT00660010|E1|Reported Event|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
469191|NCT00660023|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
469192|NCT00660023|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.0 and 12.0 grams per deciliter (g/dL).
469193|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
469194|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
469195|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
469196|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
469197|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
469198|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
469199|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
469200|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
469201|NCT00660023|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
469202|NCT00660049|B1|Baseline|Open Label Single Arm Study|Eligible participants
469270|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469271|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469203|NCT00660049|P1|Participant Flow|SNaP Application|"This is an open label pilot study of SMart Negative Pressure (SNaP) Advanced Wound Care System
SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions
SNaP: Daily use
SNaP: Daily application per protocol"
469204|NCT00660049|O1|Outcome|Open Label Single Arm Study|All participants who use the device
469205|NCT00660049|E1|Reported Event|Eligible Participants|"This is an open label pilot study of SNaP Advanced Wound Care System
SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions
SNaP: Daily use
SNaP: Daily application per protocol"
469206|NCT00660075|B3|Baseline|Total|Total of all reporting groups
469207|NCT00660075|B2|Baseline|Placebo|Placebo for 6 weeks
469208|NCT00660075|B1|Baseline|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
469209|NCT00660075|P2|Participant Flow|Sitagliptin First, Then Placebo|Participants were first administered Sitagliptin 100 mg/d for 6 weeks followed by a washout period of 4 weeks and were then switched over to placebo for 6 weeks.
469210|NCT00660075|P1|Participant Flow|Placebo First, Then Sitagliptin|Participants were first administered placebo for 6 weeks followed by a washout period of 4 weeks and were then switched over to Sitagliptin 100 mg/d for 6 weeks.
469211|NCT00660075|O2|Outcome|Sitagliptin 100 mg/d|Sitagliptin 100 mg/d for 6 weeks
469212|NCT00660075|O1|Outcome|Placebo|Placebo for 6 weeks
469221|NCT00660179|P1|Participant Flow|Placebo|Matching ACT-064992 placebo tablet, once daily
469222|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
469223|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
469224|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
469225|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
469226|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
469227|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
469228|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
469229|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
469230|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
469231|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
469232|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
469233|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
469234|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
469235|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
469236|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
469237|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
469238|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
469239|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
469240|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
469241|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
469242|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
469243|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
469244|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
469245|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
469246|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
469247|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
469248|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
469249|NCT00660179|E3|Reported Event|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
469250|NCT00660179|E2|Reported Event|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
469251|NCT00660179|E1|Reported Event|Placebo|Matching ACT-064992 placebo tablet, once daily
469252|NCT00660192|B3|Baseline|Total|Total of all reporting groups
469253|NCT00660192|B2|Baseline|Botox|
469254|NCT00660192|B1|Baseline|Placebo|
469255|NCT00660192|P2|Participant Flow|Botox|Subjects randomized to receive 200-300units of onobotulinumtoxinA by injections into the scalp and neck muscles
469256|NCT00660192|P1|Participant Flow|Placebo|Subjects randomized to placebo ho receive injections of 2cc's to 3cc's of saline solution. into muscle of the scalp and neck.
469257|NCT00660192|O2|Outcome|Botullinum Toxin|Subjects injected with 100-200 units of botox depending on body and neck size
469258|NCT00660192|O1|Outcome|Placebo|Inactive Saline
469259|NCT00660192|O2|Outcome|Botullinum Toxin|Subjects injected with 100-200 units of botox depending on body and neck size
469260|NCT00660192|O1|Outcome|Placebo|Inactive Saline
469261|NCT00660192|E2|Reported Event|Botox|
469262|NCT00660192|E1|Reported Event|Saline|
469263|NCT00653224|B3|Baseline|Total|Total of all reporting groups
469264|NCT00653224|B2|Baseline|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469265|NCT00653224|B1|Baseline|Placebo|Matching oral placebo tablet daily for 14 days
469266|NCT00653224|P2|Participant Flow|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469267|NCT00653224|P1|Participant Flow|Placebo|Matching oral placebo tablet daily for 14 days
469268|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469272|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469273|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469274|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469275|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469276|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469277|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469278|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469279|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469280|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469281|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469282|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469283|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469284|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469285|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469286|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469287|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469288|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469289|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469290|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469291|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469292|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469293|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469294|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469295|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469296|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469297|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469298|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469299|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469300|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469301|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469302|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469303|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469304|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469305|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469306|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469307|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469308|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469309|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469310|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469311|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469312|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469313|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469314|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469315|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469316|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469317|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469318|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469319|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469320|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469321|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469322|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469323|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469324|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469325|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469326|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469327|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469328|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469329|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469330|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469331|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469332|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469333|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469334|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469335|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469336|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469337|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469338|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469339|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469340|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469341|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469342|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469343|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469344|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469345|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469346|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469347|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469348|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469349|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469350|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469351|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469352|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469353|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469354|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469355|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469356|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469357|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469358|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469359|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469360|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469361|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469362|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469363|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469364|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469365|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469366|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469367|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469368|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469369|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469370|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469371|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469372|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469373|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469374|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469375|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469376|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469377|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469378|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469379|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469380|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469381|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469382|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469383|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469384|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469385|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469386|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469387|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469388|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469389|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469390|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469391|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469392|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469393|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469394|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469395|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469396|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469397|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469398|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469399|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469400|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469401|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469402|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469403|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469404|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469405|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469406|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469407|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469408|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469409|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469410|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469411|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469412|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469413|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469414|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469415|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469416|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469417|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469418|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469419|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469420|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469421|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469422|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469423|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469424|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469425|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469426|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469427|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469428|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469429|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469430|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469431|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469432|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469433|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469434|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469435|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469436|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469437|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469438|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469439|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469440|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469441|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469442|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469443|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469444|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469445|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469446|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469447|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
469448|NCT00653224|E2|Reported Event|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
469449|NCT00653224|E1|Reported Event|Placebo|Matching oral placebo tablet daily for 14 days
469450|NCT00653263|B1|Baseline|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
469451|NCT00653263|P1|Participant Flow|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
469452|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
469453|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
469454|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
469455|NCT00653263|E1|Reported Event|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
469456|NCT00653328|B1|Baseline|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
469457|NCT00653328|P1|Participant Flow|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
469458|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
469459|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
469460|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
469461|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
469462|NCT00653328|E1|Reported Event|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
469463|NCT00653523|B1|Baseline|Ezetimibe + Simvastatin|Ezetimibe 10 mg + Simvastatin 20 mg
469464|NCT00653523|P1|Participant Flow|Ezetimibe + Simvastatin|"Ezetimibe 10 mg + Simvastatin 20 mg
level below what was specified in inclusion criterion
level >2x upper limit of normal at start of treatment
level >=3x upper limit of normal after start of treatment
did not resolve or improve after dose reduction of simvastatin"
469465|NCT00653523|O1|Outcome|Ezetimibe + Simvastatin|Ezetimibe 10 mg + Simvastatin 20 mg
469466|NCT00653523|E1|Reported Event|Ezetimibe+Simvastatin|
469841|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
469467|NCT00653861|B1|Baseline|Total Study Participants|Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.
469468|NCT00653861|P1|Participant Flow|Total Study Participants|Subjects who received Juvederm with Lidocaine in one nasolabial fold and Juvederm without Lidocaine in the other nasolabial fold
469469|NCT00653861|O2|Outcome|Juvéderm NLFs|Nasolabial folds on the corresponding side of the face injected with Juvederm
469470|NCT00653861|O1|Outcome|Juvéderm Lidocaine NLFs|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
469471|NCT00653861|O1|Outcome|Total Study Participants|Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.
469472|NCT00653861|O2|Outcome|Juvéderm Nasolabial Folds (NLFs)|Nasolabial folds on the corresponding side of the face injected with Juvederm
469473|NCT00653861|O1|Outcome|Juvéderm Lidocaine Nasolabial Folds (NLFs)|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
469474|NCT00653861|E2|Reported Event|Juvéderm Nasolabial Folds (NLFs)|Nasolabial folds on the corresponding side of the face injected with Juvederm
469475|NCT00653861|E1|Reported Event|Juvéderm Lidocaine Nasolabial Folds (NLFs)|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
469476|NCT00653939|B3|Baseline|Total|Total of all reporting groups
469507|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
469508|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
469509|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
469510|NCT00654004|E2|Reported Event|Controls|Subjects do not have a fatty acid oxidation disorder.
469512|NCT00654030|B1|Baseline|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
469477|NCT00653939|B2|Baseline|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469478|NCT00653939|B1|Baseline|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469479|NCT00653939|P2|Participant Flow|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469480|NCT00653939|P1|Participant Flow|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469481|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469482|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469483|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469484|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469485|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469486|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469511|NCT00654004|E1|Reported Event|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
469487|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469488|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469489|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469490|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469491|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469492|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469493|NCT00653939|E2|Reported Event|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469494|NCT00653939|E1|Reported Event|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
469495|NCT00654004|B3|Baseline|Total|Total of all reporting groups
469496|NCT00654004|B2|Baseline|Controls|Subjects do not have a fatty acid oxidation disorder.
469497|NCT00654004|B1|Baseline|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
469498|NCT00654004|P2|Participant Flow|Controls|Subjects do not have a fatty acid oxidation disorder.
469499|NCT00654004|P1|Participant Flow|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
469500|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
469501|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
469502|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
469503|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
469504|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
469505|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
469506|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
469513|NCT00654030|P1|Participant Flow|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
469514|NCT00654030|O1|Outcome|1650-G ARM|2 immunizations of 1650-G given 4 weeks apart
469515|NCT00654030|E1|Reported Event|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
469516|NCT00654095|B1|Baseline|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
469517|NCT00654095|P1|Participant Flow|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
469518|NCT00654095|O1|Outcome|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
469519|NCT00654095|E1|Reported Event|Ezetimibe+Atorvastatin|
469520|NCT00654147|B3|Baseline|Total|Total of all reporting groups
469521|NCT00654147|B2|Baseline|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours for 48 weeks & emtricitabine 200mg/ tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
469522|NCT00654147|B1|Baseline|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet every 12 hours for 48 & Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
469523|NCT00654147|P2|Participant Flow|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
469524|NCT00654147|P1|Participant Flow|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
469525|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
469526|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
469527|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
469528|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
469529|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
469530|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
469531|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
469532|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
469533|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
469534|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
469636|NCT00654381|O2|Outcome|Linagliptin 10mg|The patients with linagliptin 10 mg at the start of randomised study medication
469842|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
469535|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
469536|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
469537|NCT00654147|E2|Reported Event|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
469538|NCT00654147|E1|Reported Event|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
469539|NCT00654186|B1|Baseline|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
469540|NCT00654186|P1|Participant Flow|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
469541|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
469542|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
469543|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
469544|NCT00654186|E1|Reported Event|Revlimid Orally for 21 Days|Revlimid: 25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
469545|NCT00654329|B5|Baseline|Total|Total of all reporting groups
469546|NCT00654329|B4|Baseline|Normal Saline Placebo|Normal saline placebo intranasal
469547|NCT00654329|B3|Baseline|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
469548|NCT00654329|B2|Baseline|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
469549|NCT00654329|B1|Baseline|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
469550|NCT00654329|P4|Participant Flow|Normal Saline Placebo|Normal saline placebo intranasal
469551|NCT00654329|P3|Participant Flow|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
469552|NCT00654329|P2|Participant Flow|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
469553|NCT00654329|P1|Participant Flow|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
469554|NCT00654329|O4|Outcome|Normal Saline Placebo|Normal saline placebo intranasal
469555|NCT00654329|O3|Outcome|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
469556|NCT00654329|O2|Outcome|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
469557|NCT00654329|O1|Outcome|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
469558|NCT00654329|O4|Outcome|Normal Saline Placebo|Normal saline placebo intranasal
469559|NCT00654329|O3|Outcome|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
469560|NCT00654329|O2|Outcome|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
469561|NCT00654329|O1|Outcome|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
469562|NCT00654329|E4|Reported Event|Normal Saline Placebo|Normal saline placebo intranasal
469563|NCT00654329|E3|Reported Event|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
469564|NCT00654329|E2|Reported Event|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
469565|NCT00654329|E1|Reported Event|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
469566|NCT00654355|B3|Baseline|Total|Total of all reporting groups
469567|NCT00654355|B2|Baseline|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
469568|NCT00654355|B1|Baseline|Control Group|Group only had visits at Baseline and Week 4.
469569|NCT00654355|P2|Participant Flow|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
469570|NCT00654355|P1|Participant Flow|Control Group|Group only had visits at Baseline and Week 4.
469571|NCT00654355|O2|Outcome|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
469572|NCT00654355|O1|Outcome|Control Group|Group only had visits at Baseline and Week 4.
469573|NCT00654355|O2|Outcome|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
469574|NCT00654355|O1|Outcome|Control Group|Group only had visits at Baseline and Week 4.
469575|NCT00654355|O2|Outcome|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
469576|NCT00654355|O1|Outcome|Control Group|Group only had visits at Baseline and Week 4.
469577|NCT00654355|E2|Reported Event|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
469578|NCT00654355|E1|Reported Event|Control Group|Group only had visits at Baseline and Week 4.
469579|NCT00654368|B4|Baseline|Total|Total of all reporting groups
469580|NCT00654368|B3|Baseline|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469581|NCT00654368|B2|Baseline|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469582|NCT00654368|B1|Baseline|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
469583|NCT00654368|P3|Participant Flow|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469584|NCT00654368|P2|Participant Flow|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469585|NCT00654368|P1|Participant Flow|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
469586|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469587|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469588|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469651|NCT00654381|E7|Reported Event|Linagliptin 5mg (Extension Stage After Voglibose)|
469589|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469590|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469591|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469592|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469593|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469594|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469595|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469596|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469597|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469598|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469599|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469600|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469601|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469602|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469843|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
469603|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469604|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469605|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469606|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469607|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469652|NCT00654381|E6|Reported Event|Voglibose (1st-2nd Stage)|
469653|NCT00654381|E5|Reported Event|Linagliptin 10mg (1st-2nd-Extension Stage)|
469654|NCT00654381|E4|Reported Event|Linagliptin 5mg (1st-2nd-Extension Stage)|
469608|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469609|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469610|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469611|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469612|NCT00654368|E3|Reported Event|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
469613|NCT00654368|E2|Reported Event|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
469614|NCT00654368|E1|Reported Event|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
469615|NCT00654381|B5|Baseline|Total|Total of all reporting groups
469616|NCT00654381|B4|Baseline|Voglibose|The patients with voglibose at the start of randomised study medication
469617|NCT00654381|B3|Baseline|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
469618|NCT00654381|B2|Baseline|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
469619|NCT00654381|B1|Baseline|Placebo|The patients with placebo at the start of randomised study medication
469620|NCT00654381|P6|Participant Flow|Voglibose - Voglibose - Linagliptin 10mg|Voglibose in Stage 1 - Voglibose in Stage 2 - 10 mg in Stage 3
469621|NCT00654381|P5|Participant Flow|Voglibose - Voglibose - Linagliptin 5mg|Voglibose in Stage 1 - Voglibose in Stage 2 - 5 mg in Stage 3
469622|NCT00654381|P4|Participant Flow|Linagliptin 10 mg - Linagliptin 10 mg - Linagliptin 10 mg|10 mg in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
469623|NCT00654381|P3|Participant Flow|Linagliptin 5mg - Linagliptin 5mg - Linagliptin 5mg|5 mg in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
469624|NCT00654381|P2|Participant Flow|Placebo - Linagliptin 5mg - Linagliptin 10mg|Placebo in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
469625|NCT00654381|P1|Participant Flow|Placebo - BI1356 (Linagliptin) 5mg - Linagliptin 5mg|Placebo in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
469626|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
469627|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
469628|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
469629|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
469630|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
469631|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
469632|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
469633|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
469634|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
469635|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
469637|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
469638|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
469639|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
469640|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
469641|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
469642|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
469643|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
469644|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
469645|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
469646|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
469647|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
469648|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
469649|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
469650|NCT00654381|E8|Reported Event|Linagliptin 10mg (Extension Stage After Voglibose)|
469655|NCT00654381|E3|Reported Event|Linagliptin 10mg (2nd-Extension Stage After Placebo)|
469656|NCT00654381|E2|Reported Event|Linagliptin 5mg (2nd-Extension Stage After Placebo)|
469657|NCT00654381|E1|Reported Event|Placebo (1st Stage)|
469658|NCT00660309|B3|Baseline|Total|Total of all reporting groups
469659|NCT00660309|B2|Baseline|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469660|NCT00660309|B1|Baseline|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469661|NCT00660309|P2|Participant Flow|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469662|NCT00660309|P1|Participant Flow|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469663|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469664|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469665|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469666|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469667|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469668|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469669|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469670|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469671|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469672|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469673|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469674|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469675|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469676|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469677|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469678|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469679|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469844|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
469680|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469681|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469682|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469683|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469684|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469685|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469686|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469687|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469688|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469689|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469690|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469691|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469692|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469693|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469694|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469695|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469696|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469697|NCT00660309|E3|Reported Event|Irbesartan 300 mg|Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
469698|NCT00660309|E2|Reported Event|Aliskiren 300 mg|Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
469699|NCT00660309|E1|Reported Event|Captopril 25 mg|On Day 1 participants received a single oral dose of 25 mg captopril.
469700|NCT00660348|B3|Baseline|Total|Total of all reporting groups
469701|NCT00660348|B2|Baseline|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.
Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
469702|NCT00660348|B1|Baseline|Morphine|"morphine given traditionally (IV, pill, patch)
morphine sulfate: This is morphine given in the traditional methods."
469703|NCT00660348|P2|Participant Flow|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.
Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
469704|NCT00660348|P1|Participant Flow|Morphine|"morphine given traditionally (IV, pill, patch)
morphine sulfate: This is morphine given in the traditional methods."
469705|NCT00660348|O2|Outcome|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine. Morphine is FDA approved for intrathecal use. The intrathecal pump will be titrated gradually to effect by the interventional pain medicine team. These are the maximum doses and concentrations in keeping with the Polyanalgesic Consensus Conference guidelines: Dose (mg/day):15 ; Conc (mg/cc): 20
Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
469706|NCT00660348|O1|Outcome|Morphine|"morphine given traditionally (IV, pill, patch). This is standard of care dosing.
morphine sulfate: This is morphine given in the traditional methods."
469707|NCT00660348|E2|Reported Event|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.
Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
469708|NCT00660348|E1|Reported Event|Morphine|"morphine given traditionally (IV, pill, patch)
morphine sulfate: This is morphine given in the traditional methods."
469709|NCT00660387|B3|Baseline|Total|Total of all reporting groups
469710|NCT00660387|B2|Baseline|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469711|NCT00660387|B1|Baseline|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469789|NCT00660517|B2|Baseline|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
469845|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
469712|NCT00660387|P2|Participant Flow|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469713|NCT00660387|P1|Participant Flow|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469714|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469715|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469716|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469717|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
473941|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
469718|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469719|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469720|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469721|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469722|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469723|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469724|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469725|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469726|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469727|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469728|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469729|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469730|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469731|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469753|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469732|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469733|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469734|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469735|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469736|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469737|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469738|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469739|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469740|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469741|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469742|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469743|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469744|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469745|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469746|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469747|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469748|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469749|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469750|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469751|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469752|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469754|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469755|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469756|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469757|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469758|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469759|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469760|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469761|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469762|NCT00660387|E2|Reported Event|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
469763|NCT00660387|E1|Reported Event|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
469764|NCT00660400|B1|Baseline|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
469765|NCT00660400|P1|Participant Flow|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
469766|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
469767|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
469768|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
469769|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
469770|NCT00660400|E1|Reported Event|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
469771|NCT00660504|B3|Baseline|Total|Total of all reporting groups
469772|NCT00660504|B2|Baseline|Etoposide, Anticancer, Injection|
469773|NCT00660504|B1|Baseline|Amrubicin, Anticancer, Injection|
469774|NCT00660504|P2|Participant Flow|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
469775|NCT00660504|P1|Participant Flow|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
469776|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
469777|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
469778|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
469779|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
469780|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
469781|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
469782|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
469783|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
469784|NCT00660504|E2|Reported Event|Etoposide, Anticancer, Injection|
469785|NCT00660504|E1|Reported Event|Amrubicin, Anticancer, Injection|
469786|NCT00660517|B5|Baseline|Total|Total of all reporting groups
469787|NCT00660517|B4|Baseline|Placebo|nasal spray
469788|NCT00660517|B3|Baseline|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
469839|NCT00660816|P1|Participant Flow|Active Comparator|Alimta or Taxotere alone
469790|NCT00660517|B1|Baseline|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
469791|NCT00660517|P4|Participant Flow|Placebo|nasal spray
469792|NCT00660517|P3|Participant Flow|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
469793|NCT00660517|P2|Participant Flow|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
469794|NCT00660517|P1|Participant Flow|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
469795|NCT00660517|O4|Outcome|Placebo|nasal spray
469796|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
469797|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
469798|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
469799|NCT00660517|O4|Outcome|Placebo|placebo nasal spray one spray per nostril two times a day
469800|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
469801|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
469802|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
469803|NCT00660517|O4|Outcome|Placebo|nasal spray
469804|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
469805|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
469806|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
469807|NCT00660517|E4|Reported Event|Placebo|nasal spray
469808|NCT00660517|E3|Reported Event|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
469809|NCT00660517|E2|Reported Event|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
469810|NCT00660517|E1|Reported Event|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
469811|NCT00660543|B1|Baseline|Gadoteridol + Ferumoxytol Contrast Agent|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
469812|NCT00660543|P1|Participant Flow|Gadoteridol + Ferumoxytol Contrast Agent|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
469813|NCT00660543|O1|Outcome|Tumor Progression on Conventional MR|Tumor progression was assessed by RANO criteria (Wen, 2010).
469814|NCT00660543|O3|Outcome|Gadoteridol Leakage Correction|Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
469815|NCT00660543|O2|Outcome|Gadoteridol|Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
469816|NCT00660543|O1|Outcome|Ferumoxytol|Patients receive gadolinium IV on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
469817|NCT00660543|E3|Reported Event|Gadoteridol With Leakage Correction|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
469818|NCT00660543|E2|Reported Event|Gadoteridol|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
469819|NCT00660543|E1|Reported Event|Ferumoxytol|Subjects all received ferumoxytol enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
469820|NCT00660595|B3|Baseline|Total|Total of all reporting groups
469821|NCT00660595|B2|Baseline|Risperdal|Risperidone, oral administration
469822|NCT00660595|B1|Baseline|Seroquel|Quetiapine Prolong, oral administration
469823|NCT00660595|P2|Participant Flow|Risperdal|Risperidone, oral administration
469824|NCT00660595|P1|Participant Flow|Seroquel|Quetiapine Prolong, oral administration
469825|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
469826|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
469827|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
469828|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
469829|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
469830|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
469831|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
469832|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
469833|NCT00660595|E2|Reported Event|Risperdal|Risperidone, oral administration
469834|NCT00660595|E1|Reported Event|Seroquel|Quetiapine Prolong, oral administration
469835|NCT00660816|B3|Baseline|Total|Total of all reporting groups
469836|NCT00660816|B2|Baseline|Experimental|Alimta or Taxotere and Tarceva
469837|NCT00660816|B1|Baseline|Active Comparator|Alimta or Taxotere alone
469838|NCT00660816|P2|Participant Flow|Experimental|Alimta or Taxotere and Tarceva
469846|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
469847|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
469848|NCT00660816|E2|Reported Event|Experimental|Alimta or Taxotere and Tarceva
469849|NCT00660816|E1|Reported Event|Active Comparator|Alimta or Taxotere alone
469850|NCT00660829|B3|Baseline|Total|Total of all reporting groups
469851|NCT00660829|B2|Baseline|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
469852|NCT00660829|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
469853|NCT00660829|P2|Participant Flow|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
469854|NCT00660829|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
469855|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
469856|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
469857|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
469858|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
469859|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
469860|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
469861|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
469862|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
469863|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
469864|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
469865|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
469866|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
469867|NCT00660829|E2|Reported Event|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
469868|NCT00660829|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
469869|NCT00660907|B3|Baseline|Total|Total of all reporting groups
469870|NCT00660907|B2|Baseline|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
469871|NCT00660907|B1|Baseline|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
469872|NCT00660907|P2|Participant Flow|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
469873|NCT00660907|P1|Participant Flow|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
469874|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
469875|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
469876|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
469877|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
469878|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
469879|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
469880|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
469881|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
469882|NCT00660907|E2|Reported Event|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
469883|NCT00660907|E1|Reported Event|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
469884|NCT00660985|B3|Baseline|Total|Total of all reporting groups
469885|NCT00660985|B2|Baseline|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469886|NCT00660985|B1|Baseline|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469887|NCT00660985|P2|Participant Flow|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469888|NCT00660985|P1|Participant Flow|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469889|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469890|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469891|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469892|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469893|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469894|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469895|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469896|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469897|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469898|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469899|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469900|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469901|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469902|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469903|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469904|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469905|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469906|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469907|NCT00660985|E2|Reported Event|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
469908|NCT00660985|E1|Reported Event|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
469909|NCT00661037|B3|Baseline|Total|Total of all reporting groups
473082|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
469910|NCT00661037|B2|Baseline|no VF Induction|Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
469911|NCT00661037|B1|Baseline|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
469912|NCT00661037|P2|Participant Flow|no VF Induction|"Patients not having VF induction at implant or during follow-up
Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock."
469913|NCT00661037|P1|Participant Flow|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
469914|NCT00661037|O2|Outcome|No- VF Induction|Patients not having VF induction at implant or during follow-up
469915|NCT00661037|O1|Outcome|VF Induction|Patients having VF induction with shock termination at implant
469916|NCT00661037|O2|Outcome|no VF Induction|Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
469917|NCT00661037|O1|Outcome|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
469918|NCT00661037|O2|Outcome|no VF Induction|Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
469919|NCT00661037|O1|Outcome|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
469920|NCT00661037|E2|Reported Event|no VF Induction|Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
469921|NCT00661037|E1|Reported Event|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
469922|NCT00661089|B3|Baseline|Total|Total of all reporting groups
469923|NCT00661089|B2|Baseline|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.
Blind broken and receives botulinum toxin at week 12"
469924|NCT00661089|B1|Baseline|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
469925|NCT00661089|P2|Participant Flow|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.
Blind broken and receives botulinum toxin at week 12"
469926|NCT00661089|P1|Participant Flow|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
469927|NCT00661089|O2|Outcome|Botulinum Toxin Injection|Group received botulinum toxin type A (Botox) in the pectoralis and teres major muscles
469928|NCT00661089|O1|Outcome|Placebo|Group received saline injections intramuscularly of equivalent volume
469929|NCT00661089|O2|Outcome|Botulinum Toxin Injection|Group received botulinum toxin type A (Botox) in the pectoralis and teres major muscles
469930|NCT00661089|O1|Outcome|Placebo|Group recieved saline injections intramuscularly of equivalent volume
469931|NCT00661089|E2|Reported Event|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.
Blind broken and receives botulinum toxin at week 12"
469932|NCT00661089|E1|Reported Event|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
469933|NCT00661193|B3|Baseline|Total|Total of all reporting groups
469934|NCT00661193|B2|Baseline|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
469935|NCT00661193|B1|Baseline|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
469936|NCT00661193|P2|Participant Flow|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
469937|NCT00661193|P1|Participant Flow|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
469938|NCT00661193|O2|Outcome|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
469939|NCT00661193|O1|Outcome|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
469940|NCT00661193|O2|Outcome|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
469941|NCT00661193|O1|Outcome|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
469970|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
469971|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
469942|NCT00661193|E2|Reported Event|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
469943|NCT00661193|E1|Reported Event|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
469944|NCT00661258|B3|Baseline|Total|Total of all reporting groups
469945|NCT00661258|B2|Baseline|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
469946|NCT00661258|B1|Baseline|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
470011|NCT00661479|B2|Baseline|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
469947|NCT00661258|P2|Participant Flow|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
469948|NCT00661258|P1|Participant Flow|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
469949|NCT00661258|O2|Outcome|Control|The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for
469950|NCT00661258|O1|Outcome|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
469951|NCT00661258|O2|Outcome|Control|The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for
469952|NCT00661258|O1|Outcome|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
469953|NCT00661258|E2|Reported Event|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
469954|NCT00661258|E1|Reported Event|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
469955|NCT00661362|B3|Baseline|Total|Total of all reporting groups
469956|NCT00661362|B2|Baseline|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
469957|NCT00661362|B1|Baseline|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
469958|NCT00661362|P2|Participant Flow|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
469959|NCT00661362|P1|Participant Flow|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
469960|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
469961|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
469962|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
469963|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
469964|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
469965|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
469966|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
469967|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
469968|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
469969|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
470000|NCT00661427|O2|Outcome|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
469972|NCT00661362|E2|Reported Event|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
469973|NCT00661362|E1|Reported Event|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
469974|NCT00661388|B1|Baseline|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469975|NCT00661388|P1|Participant Flow|C.E.R.A|Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A) subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 micrograms (mcg)/kilogram (kg). Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) within the target range of 10.0 and 12.0 grams (g)/ deciliter (dL).
469976|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469977|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
470012|NCT00661479|B1|Baseline|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
469978|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469979|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469980|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469981|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469982|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469983|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469984|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469985|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469986|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469987|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469988|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469989|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469990|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469991|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469992|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469993|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469994|NCT00661388|E1|Reported Event|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
469995|NCT00661427|B3|Baseline|Total|Total of all reporting groups
469996|NCT00661427|B2|Baseline|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
469997|NCT00661427|B1|Baseline|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
469998|NCT00661427|P2|Participant Flow|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
469999|NCT00661427|P1|Participant Flow|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
473083|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
470001|NCT00661427|O1|Outcome|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
470002|NCT00661427|E2|Reported Event|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
470003|NCT00661427|E1|Reported Event|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
470004|NCT00661453|B1|Baseline|SMA Type 1|"All patients will receive VPA and carnitine.
Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
470005|NCT00661453|P1|Participant Flow|SMA Type 1|"All patients will receive VPA and carnitine.
Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
470006|NCT00661453|O1|Outcome|SMA Type 1|"All patients will receive VPA and carnitine.
Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
470007|NCT00661453|E1|Reported Event|SMA Type 1|"All patients will receive VPA and carnitine.
Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
470008|NCT00661479|B5|Baseline|Total|Total of all reporting groups
470009|NCT00661479|B4|Baseline|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470010|NCT00661479|B3|Baseline|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470013|NCT00661479|P4|Participant Flow|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470014|NCT00661479|P3|Participant Flow|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470015|NCT00661479|P2|Participant Flow|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470016|NCT00661479|P1|Participant Flow|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470017|NCT00661479|O4|Outcome|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470018|NCT00661479|O3|Outcome|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470019|NCT00661479|O2|Outcome|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470020|NCT00661479|O1|Outcome|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470021|NCT00661479|O4|Outcome|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470022|NCT00661479|O3|Outcome|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470023|NCT00661479|O2|Outcome|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470024|NCT00661479|O1|Outcome|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470025|NCT00661479|E3|Reported Event|100 µg Brimonidine Tartrate Implant Groups A and B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470026|NCT00661479|E2|Reported Event|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470027|NCT00661479|E1|Reported Event|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
470028|NCT00661492|B3|Baseline|Total|Total of all reporting groups
470029|NCT00661492|B2|Baseline|Arm 2|Novantrone
470030|NCT00661492|B1|Baseline|Arm 1|Novantrone+Erbitux
470031|NCT00661492|P2|Participant Flow|Arm 2|Novantrone
470032|NCT00661492|P1|Participant Flow|Arm 1|Novantrone+Erbitux
470033|NCT00661492|O2|Outcome|Arm 2|Novantrone
470034|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
470035|NCT00661492|O2|Outcome|Arm 2|Novantrone
470036|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
470037|NCT00661492|O2|Outcome|Arm 2|Novantrone
470038|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
470039|NCT00661492|O2|Outcome|Arm 2|Novantrone
470040|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
470041|NCT00661492|O2|Outcome|Arm 2|Novantrone
470042|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
470043|NCT00661492|O2|Outcome|Arm 2|Novantrone
470044|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
470045|NCT00661492|O2|Outcome|Arm 2|Novantrone
470046|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
470047|NCT00661492|O2|Outcome|Arm 2|Novantrone
470048|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
470049|NCT00661492|E2|Reported Event|Arm 2|Novantrone
470050|NCT00661492|E1|Reported Event|Arm 1|Novantrone+Erbitux
470051|NCT00661505|B1|Baseline|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470090|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
471492|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
470052|NCT00661505|P1|Participant Flow|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470053|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470102|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
470103|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
470227|NCT00661674|O2|Outcome|Palonosetron|Each participant had one session in which they received palonosetron IV pretreatment prior to naloxone-precipitated withdrawal.
470054|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470055|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470056|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470057|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470058|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470059|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470060|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470061|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470091|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
470092|NCT00661570|E1|Reported Event|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
470093|NCT00661583|B4|Baseline|Total|Total of all reporting groups
470062|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470063|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470064|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470065|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470066|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470067|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470068|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470069|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470070|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470071|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470094|NCT00661583|B3|Baseline|MMC Alone|"MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
470095|NCT00661583|B2|Baseline|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
473084|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
470072|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470073|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470074|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470075|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470076|NCT00661505|E1|Reported Event|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
470077|NCT00661531|B1|Baseline|Estrace & Anastrozole|Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
470078|NCT00661531|P1|Participant Flow|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
Estrace: Estrace 10 mg three times daily will be administered for 3 months.
Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
470079|NCT00661531|O1|Outcome|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
Estrace: Estrace 10 mg three times daily will be administered for 3 months.
Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
470080|NCT00661531|O1|Outcome|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
Estrace: Estrace 10 mg three times daily will be administered for 3 months.
Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
470081|NCT00661531|E1|Reported Event|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
Estrace: Estrace 10 mg three times daily will be administered for 3 months.
Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
470082|NCT00661544|B1|Baseline|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
470083|NCT00661544|P1|Participant Flow|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
470084|NCT00661544|O1|Outcome|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
470085|NCT00661544|E1|Reported Event|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
470086|NCT00661570|B1|Baseline|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
470087|NCT00661570|P1|Participant Flow|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
470088|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
470089|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
470253|NCT00661713|P6|Participant Flow|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470096|NCT00661583|B1|Baseline|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
470097|NCT00661583|P3|Participant Flow|MMC Alone|"MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
470098|NCT00661583|P2|Participant Flow|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
470099|NCT00661583|P1|Participant Flow|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
470100|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
470101|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
470104|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
470105|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
470106|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
470107|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
470108|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
470109|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
470110|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
470111|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
470112|NCT00661583|E3|Reported Event|MMC Alone|"MMC therapy alone (n=10)
MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
470113|NCT00661583|E2|Reported Event|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
470114|NCT00661583|E1|Reported Event|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
470115|NCT00661609|B1|Baseline|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
470116|NCT00661609|P1|Participant Flow|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
470117|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
470118|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
470119|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
470120|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
470121|NCT00661609|E1|Reported Event|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
470122|NCT00661622|B3|Baseline|Total|Total of all reporting groups
470123|NCT00661622|B2|Baseline|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470124|NCT00661622|B1|Baseline|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470125|NCT00661622|P2|Participant Flow|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470126|NCT00661622|P1|Participant Flow|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470127|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
473085|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
470128|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470129|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470130|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470226|NCT00661674|O3|Outcome|Palonosetron + Hydroxyzine|Each participant had one session in which they received IV palonosetron + PO hydroxyzine pretreatment prior to naloxone-precipitated withdrawal.
470506|NCT00662155|B2|Baseline|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
470131|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470132|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470133|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470134|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470135|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470136|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.
GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470137|NCT00661622|E2|Reported Event|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF
Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
470138|NCT00661622|E1|Reported Event|Immunoembolization|Liver embolization treatment with injection of GM-CSF.
470139|NCT00661661|B3|Baseline|Total|Total of all reporting groups
470140|NCT00661661|B2|Baseline|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470141|NCT00661661|B1|Baseline|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470142|NCT00661661|P2|Participant Flow|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470143|NCT00661661|P1|Participant Flow|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470144|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470145|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470146|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470147|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470148|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470149|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470150|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470151|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470152|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470153|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470154|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470155|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470156|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470157|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470158|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470159|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470160|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470161|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470254|NCT00661713|P5|Participant Flow|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470162|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470163|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470164|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470165|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470166|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470167|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470168|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470169|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470170|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470171|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470172|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470173|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470174|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470175|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470176|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470177|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470255|NCT00661713|P4|Participant Flow|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470178|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470179|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470180|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470181|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470182|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470183|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470184|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470185|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470186|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470187|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470188|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470189|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470190|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470191|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470192|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470193|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470256|NCT00661713|P3|Participant Flow|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470194|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470195|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470196|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470197|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470198|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470199|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470200|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470201|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470202|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470203|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470204|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470205|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470206|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470207|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470208|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470209|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470257|NCT00661713|P2|Participant Flow|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470210|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470211|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470212|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470213|NCT00661661|E3|Reported Event|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
470214|NCT00661661|E2|Reported Event|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
470215|NCT00661661|E1|Reported Event|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
470216|NCT00661674|B1|Baseline|Overall Study|Over three study sessions each spaced one week apart participants received either placebo IV + PO, Palonosetron IV (0.75 mg) + placebo PO, or Palonosetron IV (0.75 mg) + Hydroxyzine PO (100mg).
470217|NCT00661674|P6|Participant Flow|Sequence 6: Palonosetron, Placebo, Combo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
Week 1: Palonosetron
Week 2: Placebo
Week 3: Combo"
470218|NCT00661674|P5|Participant Flow|Sequence 5: Combo, Palonosetron, Placebo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
Week 1: Combo
Week 2: Palonosetron
Week 3: Placebo"
470219|NCT00661674|P4|Participant Flow|Sequence 4: Placebo, Palonosetron, Combo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
Week 1: Placebo
Week 2: Palonosetron
Week 3: Combo"
470220|NCT00661674|P3|Participant Flow|Sequence 3: Combo, Placebo, Palonosetron|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
Week 1: Combo
Week 2: Placebo
Week 3: Palonosetron"
470221|NCT00661674|P2|Participant Flow|Sequence 2: Palonosetron, Combo, Placebo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
Week 1: Palonosetron
Week 2: Combo
Week 3: Placebo"
470258|NCT00661713|P1|Participant Flow|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470259|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470260|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470261|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
473086|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
470222|NCT00661674|P1|Participant Flow|Sequence 1: Placebo, Combo, Palonosetron|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
Week 1: Placebo
Week 2: Combo
Week 3: Palonosetron"
470223|NCT00661674|O3|Outcome|Palonosetron + Hydroxyzine|Each participant had one session in which they received IV palonosetron + PO hydroxyzine pretreatment prior to naloxone-precipitated withdrawal.
470224|NCT00661674|O2|Outcome|Palonosetron|Each participant had one session in which they received palonosetron IV pretreatment prior to naloxone-precipitated withdrawal.
470225|NCT00661674|O1|Outcome|Placebo|Each participant had one session in which they received a placebo tablet pretreatment prior to naloxone-precipitated withdrawal.
470228|NCT00661674|O1|Outcome|Placebo|Each participant had one session in which they received a placebo tablet pretreatment prior to naloxone-precipitated withdrawal.
470229|NCT00661674|E3|Reported Event|Palonosetron + Hydroxyzine|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
470230|NCT00661674|E2|Reported Event|Palonosetron + Placebo|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with palonosetron IV (0.75mg) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study drug combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
470231|NCT00661674|E1|Reported Event|Placebo|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with placebo (0.9% normal saline) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
470232|NCT00661687|B1|Baseline|PureVision Contact Lens|PureVision Contact Lens Original Design and New Design.
470233|NCT00661687|P1|Participant Flow|PureVision Contact Lens|PureVision Contact Lens, Original Design and Alternate Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.
470234|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
470235|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
470236|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
470237|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
470238|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
470239|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
470240|NCT00661687|E2|Reported Event|PureVision Contact Lens Design #2|PureVision Contact Lens Test Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye
470241|NCT00661687|E1|Reported Event|PureVision Contact Lens Design #1|PureVision Contact Lens, Original Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.
470242|NCT00661713|B9|Baseline|Total|Total of all reporting groups
470243|NCT00661713|B8|Baseline|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470244|NCT00661713|B7|Baseline|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470245|NCT00661713|B6|Baseline|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470246|NCT00661713|B5|Baseline|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470247|NCT00661713|B4|Baseline|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470248|NCT00661713|B3|Baseline|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470249|NCT00661713|B2|Baseline|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470250|NCT00661713|B1|Baseline|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470251|NCT00661713|P8|Participant Flow|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470252|NCT00661713|P7|Participant Flow|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
471493|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
470262|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470263|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470264|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470265|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470266|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470267|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470268|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470269|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470270|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470271|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470272|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470507|NCT00662155|B1|Baseline|QHS-10|nightly dosing with 10 mg zolpidem
470273|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470274|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470275|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470276|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470277|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470278|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470279|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470280|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470281|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470282|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470283|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470284|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470285|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470286|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470287|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470288|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470289|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470290|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470291|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470292|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470293|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470294|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470295|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470296|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470297|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470298|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470299|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470300|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470301|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470302|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470303|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470304|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470305|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470306|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470307|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470308|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470309|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470310|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470311|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470312|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470313|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470314|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470315|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470316|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470317|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470318|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470319|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470320|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470321|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470322|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470323|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470324|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470325|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470326|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470327|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470328|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470329|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470330|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470331|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470332|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470333|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470334|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470335|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470336|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470337|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470338|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470339|NCT00661713|E8|Reported Event|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
470340|NCT00661713|E7|Reported Event|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
470341|NCT00661713|E6|Reported Event|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
470342|NCT00661713|E5|Reported Event|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
470343|NCT00661713|E4|Reported Event|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
470344|NCT00661713|E3|Reported Event|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
470345|NCT00661713|E2|Reported Event|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
470346|NCT00661713|E1|Reported Event|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
470347|NCT00661726|B1|Baseline|Phase IIA Open Label, Single-arm, Multi-center Pilot Study|Participants will receive injected decitabine for 12 weeks.
470348|NCT00661726|P1|Participant Flow|Phase IIA Open Label, Single-arm, Multi-center Pilot Study|Participants will receive injected decitabine for 12 weeks.
470349|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470350|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470351|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470352|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470353|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470354|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470355|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470356|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470357|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470358|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470359|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470360|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470361|NCT00661726|E1|Reported Event|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
470362|NCT00661778|B1|Baseline|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
470363|NCT00661778|P1|Participant Flow|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
470364|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
470365|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
470366|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
470367|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
470368|NCT00661778|E1|Reported Event|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
470369|NCT00661830|B3|Baseline|Total|Total of all reporting groups
470370|NCT00661830|B2|Baseline|Gemcitabine + Placebo|"Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo"
470371|NCT00661830|B1|Baseline|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
470372|NCT00661830|P2|Participant Flow|Gemcitabine + Placebo|"Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo"
470373|NCT00661830|P1|Participant Flow|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
470374|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo"
470375|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
470376|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo"
470377|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
470378|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo"
470379|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
470380|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo"
470381|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
470382|NCT00661830|E2|Reported Event|Gemcitabine + Placebo|"Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo"
470383|NCT00661830|E1|Reported Event|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
470384|NCT00661895|B3|Baseline|Total|Total of all reporting groups
470385|NCT00661895|B2|Baseline|Control|No intervention
470420|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470386|NCT00661895|B1|Baseline|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
470387|NCT00661895|P2|Participant Flow|Control|No intervention
470388|NCT00661895|P1|Participant Flow|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
470389|NCT00661895|O2|Outcome|Control|Free antihypertensive medications, basic hypertension education and usual clinical care.
470390|NCT00661895|O1|Outcome|Intervention|Free antihypertensive medications, in-depth HTN and healthy living education, behavior change counseling, and Therapeutic Lifestyle Change following JNC-VII guidelines.
470391|NCT00661895|E2|Reported Event|Control|No intervention
470392|NCT00661895|E1|Reported Event|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
470393|NCT00661960|B4|Baseline|Total|Total of all reporting groups
473942|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
470394|NCT00661960|B3|Baseline|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
470395|NCT00661960|B2|Baseline|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
470396|NCT00661960|B1|Baseline|Negative Volunteers|HIV Negative volunteers
470397|NCT00661960|P3|Participant Flow|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
470398|NCT00661960|P2|Participant Flow|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
470399|NCT00661960|P1|Participant Flow|Negative Volunteers|HIV Negative volunteers
470400|NCT00661960|O3|Outcome|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
470401|NCT00661960|O2|Outcome|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
470402|NCT00661960|O1|Outcome|Negative Volunteers|HIV Negative volunteers
470403|NCT00661960|E3|Reported Event|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
470404|NCT00661960|E2|Reported Event|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
470405|NCT00661960|E1|Reported Event|Negative Volunteers|HIV Negative volunteers
470406|NCT00661999|B4|Baseline|Total|Total of all reporting groups
470407|NCT00661999|B3|Baseline|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470408|NCT00661999|B2|Baseline|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470409|NCT00661999|B1|Baseline|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470410|NCT00661999|P3|Participant Flow|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470411|NCT00661999|P2|Participant Flow|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470412|NCT00661999|P1|Participant Flow|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470413|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470414|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470415|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470416|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470417|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470418|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470419|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
473245|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
470421|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470422|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470423|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470424|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470425|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470426|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
473943|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
470427|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470428|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470429|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470430|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470431|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470432|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470433|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470434|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470435|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470436|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470437|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470438|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470439|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470440|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470441|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470442|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470443|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470444|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470445|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470446|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470447|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470448|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470449|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
471494|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
470450|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470451|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470452|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470453|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470454|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470455|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470456|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470457|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470458|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470459|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470460|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470461|NCT00661999|E3|Reported Event|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470462|NCT00661999|E2|Reported Event|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470463|NCT00661999|E1|Reported Event|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
470464|NCT00662012|B1|Baseline|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.
Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
470465|NCT00662012|P1|Participant Flow|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.
Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
470466|NCT00662012|O1|Outcome|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.
Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
470467|NCT00662012|O1|Outcome|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.
Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
470468|NCT00662012|E1|Reported Event|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.
Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
470469|NCT00662025|B1|Baseline|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470590|NCT00662545|P1|Participant Flow|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
471495|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
470470|NCT00662025|P1|Participant Flow|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470471|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470508|NCT00662155|P4|Participant Flow|QHS-5|nightly dosing with 5mg zolpidem
470509|NCT00662155|P3|Participant Flow|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
470510|NCT00662155|P2|Participant Flow|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
470472|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470473|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470474|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470475|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470476|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470477|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470478|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470479|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470480|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470481|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470482|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470591|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
474153|NCT00669955|B3|Baseline|Total|Total of all reporting groups
470483|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470484|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470485|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470486|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470487|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470488|NCT00662025|E1|Reported Event|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
470489|NCT00662038|B1|Baseline|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
470490|NCT00662038|P1|Participant Flow|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
470491|NCT00662038|O1|Outcome|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
470492|NCT00662038|E1|Reported Event|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
470493|NCT00662129|B1|Baseline|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
470494|NCT00662129|P1|Participant Flow|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
470495|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
470496|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
470497|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
470498|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
470499|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
470500|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
470592|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
470501|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
470502|NCT00662129|E1|Reported Event|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
470503|NCT00662155|B5|Baseline|Total|Total of all reporting groups
470504|NCT00662155|B4|Baseline|QHS-5|nightly dosing with 5mg zolpidem
470505|NCT00662155|B3|Baseline|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
470511|NCT00662155|P1|Participant Flow|QHS-10|nightly dosing with 10 mg zolpidem
470512|NCT00662155|O4|Outcome|QHS-5|nightly dosing with 5mg zolpidem
470513|NCT00662155|O3|Outcome|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
470514|NCT00662155|O2|Outcome|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
470515|NCT00662155|O1|Outcome|QHS-10|nightly dosing with 10 mg zolpidem
470516|NCT00662155|O4|Outcome|QHS-5|nightly dosing with 5mg zolpidem
470517|NCT00662155|O3|Outcome|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
470518|NCT00662155|O2|Outcome|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
470519|NCT00662155|O1|Outcome|QHS-10|nightly dosing with 10 mg zolpidem
470520|NCT00662155|E4|Reported Event|QHS-5|nightly dosing with 5mg zolpidem
470521|NCT00662155|E3|Reported Event|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
470522|NCT00662155|E2|Reported Event|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
470523|NCT00662155|E1|Reported Event|QHS-10|nightly dosing with 10 mg zolpidem
470524|NCT00662207|B1|Baseline|All Participants|
470525|NCT00662207|P1|Participant Flow|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur
Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter
A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.
Responses of the bladder and the external urethral and anal sphincters were recorded"
470526|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur
Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter
A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.
Responses of the bladder and the external urethral and anal sphincters were recorded"
470527|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur
Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter
A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.
Responses of the bladder and the external urethral and anal sphincters were recorded"
470528|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur
Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter
A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.
Responses of the bladder and the external urethral and anal sphincters were recorded"
470529|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur
Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter
A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.
Responses of the bladder and the external urethral and anal sphincters were recorded"
470530|NCT00662207|E1|Reported Event|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur
Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter
A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.
Responses of the bladder and the external urethral and anal sphincters were recorded"
470531|NCT00662311|B4|Baseline|Total|Total of all reporting groups
474752|NCT00671970|O1|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
470532|NCT00662311|B3|Baseline|Vorinostat 400 mg|"Cohort 3: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470533|NCT00662311|B2|Baseline|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470534|NCT00662311|B1|Baseline|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470535|NCT00662311|P3|Participant Flow|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470536|NCT00662311|P2|Participant Flow|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470537|NCT00662311|P1|Participant Flow|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470538|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470539|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470540|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470541|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470542|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470543|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470544|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470545|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470546|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470547|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470548|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470549|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
471496|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
470550|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470551|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470552|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470553|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470554|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470555|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470556|NCT00662311|E3|Reported Event|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470557|NCT00662311|E2|Reported Event|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470558|NCT00662311|E1|Reported Event|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
paclitaxel: Given IV
radiation therapy: Undergo radiation therapy"
470559|NCT00662363|B3|Baseline|Total|Total of all reporting groups
470560|NCT00662363|B2|Baseline|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
470561|NCT00662363|B1|Baseline|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
470562|NCT00662363|P2|Participant Flow|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
470563|NCT00662363|P1|Participant Flow|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
470564|NCT00662363|O2|Outcome|Senna|Change in PAC-QOL
470565|NCT00662363|O1|Outcome|Lubiprostone|change in PAC-QOL
470566|NCT00662363|O2|Outcome|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
470567|NCT00662363|O1|Outcome|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
470568|NCT00662363|E2|Reported Event|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
470569|NCT00662363|E1|Reported Event|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
470570|NCT00662389|B1|Baseline|A--Thermal Wand Application|
470571|NCT00662389|P1|Participant Flow|A--Thermal Wand Application|
470572|NCT00662389|O1|Outcome|A--Thermal Wand Application|
470573|NCT00662532|B3|Baseline|Total|Total of all reporting groups
470574|NCT00662532|B2|Baseline|No Intervention|Control group receiving no drug intervention
470575|NCT00662532|B1|Baseline|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
470576|NCT00662532|P2|Participant Flow|No Intervention|Control group receiving no drug intervention
470577|NCT00662532|P1|Participant Flow|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
470578|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
470579|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
470580|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
470581|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
470582|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
470583|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
470584|NCT00662532|E2|Reported Event|No Intervention|Control group receiving no drug intervention
470585|NCT00662532|E1|Reported Event|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
470586|NCT00662545|B3|Baseline|Total|Total of all reporting groups
470587|NCT00662545|B2|Baseline|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
470588|NCT00662545|B1|Baseline|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
470589|NCT00662545|P2|Participant Flow|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
470593|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
470594|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
470595|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
470596|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
470597|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
470598|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
470599|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
470600|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
470601|NCT00662545|E2|Reported Event|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
470602|NCT00662545|E1|Reported Event|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
470603|NCT00662558|B3|Baseline|Total|Total of all reporting groups
470604|NCT00662558|B2|Baseline|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470605|NCT00662558|B1|Baseline|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470606|NCT00662558|P2|Participant Flow|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470607|NCT00662558|P1|Participant Flow|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470608|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470609|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470610|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470611|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470612|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470613|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470614|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470615|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470616|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470617|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470618|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470619|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470620|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470621|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470622|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470623|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470624|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470625|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470626|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470627|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470628|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470629|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470630|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470631|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470632|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470633|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470634|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470635|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470636|NCT00662558|E2|Reported Event|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
470637|NCT00662558|E1|Reported Event|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
470638|NCT00662649|B5|Baseline|Total|Total of all reporting groups
470639|NCT00662649|B4|Baseline|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
470640|NCT00662649|B3|Baseline|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
470641|NCT00662649|B2|Baseline|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
470642|NCT00662649|B1|Baseline|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
470643|NCT00662649|P5|Participant Flow|Placebo-fingolimod 0.5|Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
470644|NCT00662649|P4|Participant Flow|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
470645|NCT00662649|P3|Participant Flow|Placebo|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
470646|NCT00662649|P2|Participant Flow|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
474753|NCT00671970|O1|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
470647|NCT00662649|P1|Participant Flow|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
470648|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
470649|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
470650|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
470651|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod (either 1.25 or 0.5 mg/day) in the Extension study.
470652|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
470653|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
470654|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
470655|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the Core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
470656|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
470657|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
470658|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
470659|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
470660|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
470661|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
470662|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
470663|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
470664|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
470665|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
470666|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
470667|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
470668|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
470669|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
470670|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
470671|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
470672|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
470673|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
470674|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
470675|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
470676|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
470677|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
470678|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
470679|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
470680|NCT00662649|E4|Reported Event|Placebo-Fingolimod 0.5mg|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 0.5 mg/day in the Extension study.
470681|NCT00662649|E3|Reported Event|Placebo-Fingolimod 1.25mg|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 1.25 mg/day in the Extension study.
470682|NCT00662649|E2|Reported Event|Fingolimod 0.5mg|Patients randomized to fingolimod 0.5 mg/day in the Core study. These patients continued the same dose in the Extension study.
470683|NCT00662649|E1|Reported Event|Fingolimod 1.25mg|Patients randomized to fingolimod 1.25 mg/day in the Core study. These patients continued the same dose in the Extension study.
470684|NCT00662675|B3|Baseline|Total|Total of all reporting groups
470685|NCT00662675|B2|Baseline|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
470686|NCT00662675|B1|Baseline|Placebo|Matching placebo capsules taken by mouth per meal or snack
470687|NCT00662675|P2|Participant Flow|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
470688|NCT00662675|P1|Participant Flow|Placebo|Matching placebo capsules taken by mouth per meal or snack
470689|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
470690|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
470691|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
470692|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
470693|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
470694|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
470695|NCT00662675|E2|Reported Event|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
470696|NCT00662675|E1|Reported Event|Placebo|Matching placebo capsules taken by mouth per meal or snack
470697|NCT00662818|B3|Baseline|Total|Total of all reporting groups
473944|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
470698|NCT00662818|B2|Baseline|Placebo and APAP 1000 mg→Telcagepant 300 mg|Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
470699|NCT00662818|B1|Baseline|Telcagepant 300 mg→APAP 1000 mg|Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
470700|NCT00662818|P2|Participant Flow|Placebo and APAP 1000 mg→Telcagepant 300 mg|Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
470701|NCT00662818|P1|Participant Flow|Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg|Participants receive up to 12 doses of telcagepant (300 mg capsule/280 mg tablet), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
470702|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
470703|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
470704|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
470705|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
470706|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
470707|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
470708|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
470709|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
470710|NCT00662818|O2|Outcome|APAP|Participants receiving APAP
470711|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
470712|NCT00662818|O2|Outcome|APAP|Participants receiving APAP
470713|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
470714|NCT00662818|O2|Outcome|Acetaminophen/Paracetamol (APAP)|Participants receiving APAP
470715|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
470716|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
470717|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
470718|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
470719|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
470720|NCT00662818|E2|Reported Event|Acetaminophen/Paracetamol|Participants receiving acetaminophen/paracetamol
470721|NCT00662818|E1|Reported Event|Telcagepant|Participants receiving telcagepant
470722|NCT00662831|B3|Baseline|Total|Total of all reporting groups
470723|NCT00662831|B2|Baseline|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470724|NCT00662831|B1|Baseline|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470725|NCT00662831|P2|Participant Flow|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470726|NCT00662831|P1|Participant Flow|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 milliliter [mL]) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470727|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470728|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470729|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470730|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470731|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470732|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470733|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470734|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470735|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470736|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470737|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470738|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470739|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470740|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470741|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470742|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470743|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470744|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470745|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470746|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470747|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470748|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470749|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470750|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470751|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470752|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470753|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470754|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470755|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470756|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470757|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470758|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470759|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470760|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470761|NCT00662831|E2|Reported Event|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
470762|NCT00662831|E1|Reported Event|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
470763|NCT00662857|B1|Baseline|Safety Population|Any subject that received at least one treatment with TI inhalation powder
470764|NCT00662857|P2|Participant Flow|TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro|Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure
470765|NCT00662857|P1|Participant Flow|TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro|Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure
470766|NCT00662857|O2|Outcome|10 U Subcutaneous (sc) Insulin Lispro|10 U of insulin lispro administered subcutaneously during a glucose clamp procedure
470767|NCT00662857|O1|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
470768|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
470769|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
470770|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
470771|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
470772|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
470773|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
470774|NCT00662857|E3|Reported Event|10 U Subcutaneous (sc) Insulin Lispro|10 U of insulin lispro administered subcutaneously during a glucose clamp procedure
470775|NCT00662857|E2|Reported Event|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
470776|NCT00662857|E1|Reported Event|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
470777|NCT00662909|B4|Baseline|Total|Total of all reporting groups
470778|NCT00662909|B3|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470779|NCT00662909|B2|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470780|NCT00662909|B1|Baseline|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470781|NCT00662909|P3|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470782|NCT00662909|P2|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470783|NCT00662909|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470784|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470785|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470786|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470787|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470788|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470789|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470790|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470791|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470792|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470793|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470794|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470795|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470796|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470797|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470798|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470799|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470800|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470801|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470802|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470803|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470804|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470805|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470806|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470807|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470808|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470809|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470810|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470811|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470812|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470813|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470814|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470815|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470816|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470817|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470818|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470819|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470820|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470821|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470822|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470823|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470824|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470825|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470826|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470827|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470828|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470829|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470830|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470831|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470832|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470833|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470834|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470835|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470836|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470837|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470838|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470839|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470840|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470841|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470842|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470843|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470844|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470845|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470846|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470847|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470848|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470849|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470850|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470851|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470852|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470853|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470854|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470855|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470856|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470857|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470858|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470859|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470860|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470861|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470862|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470863|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470864|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470865|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470866|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470867|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470868|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470869|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470870|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470871|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470872|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470873|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470874|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470875|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470876|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470877|NCT00662909|E3|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
470878|NCT00662909|E2|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
470879|NCT00662909|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
470880|NCT00663026|B4|Baseline|Total|Total of all reporting groups
470881|NCT00663026|B3|Baseline|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
470882|NCT00663026|B2|Baseline|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
470883|NCT00663026|B1|Baseline|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
474754|NCT00671970|O2|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
470884|NCT00663026|P3|Participant Flow|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
470885|NCT00663026|P2|Participant Flow|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
470886|NCT00663026|P1|Participant Flow|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
470887|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
470888|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
470889|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
470890|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
470891|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
470892|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
470893|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
471399|NCT00665431|B2|Baseline|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
470894|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
470895|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
470896|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
470897|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
470898|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
470899|NCT00663026|O3|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
470900|NCT00663026|O2|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
470901|NCT00663026|O1|Outcome|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
470902|NCT00663026|E3|Reported Event|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
470903|NCT00663026|E2|Reported Event|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
470904|NCT00663026|E1|Reported Event|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
470905|NCT00663052|B3|Baseline|Total|Total of all reporting groups
470906|NCT00663052|B2|Baseline|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470907|NCT00663052|B1|Baseline|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470908|NCT00663052|P2|Participant Flow|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470909|NCT00663052|P1|Participant Flow|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470910|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470911|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470912|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470913|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470914|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470915|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470916|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470917|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470918|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470919|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470920|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470921|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470922|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470923|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470924|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
471497|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
470925|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470926|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470927|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470928|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470929|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470930|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470931|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470932|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470933|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470934|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470935|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470936|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470937|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470938|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470939|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470940|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470941|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470942|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470943|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470944|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470945|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470946|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470947|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470948|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470949|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470950|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470951|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470952|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470953|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470954|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470955|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470956|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470991|NCT00663117|P2|Participant Flow|Naltrexone Then Naltrexone 4.5 mg po Daily|Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
470957|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470958|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470959|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470960|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470961|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470962|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470963|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470964|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470965|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470966|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470967|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470968|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470969|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470970|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470971|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470972|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470973|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470974|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470975|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470976|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470977|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470978|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470979|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470980|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470981|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470982|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470983|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470984|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470985|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470986|NCT00663052|E2|Reported Event|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
470987|NCT00663052|E1|Reported Event|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
470988|NCT00663117|B3|Baseline|Total|Total of all reporting groups
470989|NCT00663117|B2|Baseline|Naltrexone 4.5 mg po Daily|Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
470990|NCT00663117|B1|Baseline|Placebo Daily|Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
470992|NCT00663117|P1|Participant Flow|Placebo Then Naltrexone 4.5 mg Daily|Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
470993|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Subjects who received naltrexone 4.5 mg by mouth once a day for 3 months
470994|NCT00663117|O1|Outcome|Placebo|Subjects who received placebo for 3 months
470995|NCT00663117|O2|Outcome|Naltrexone 4.5 mg|naltrexone 4.5 mg for 12 weeks blinded followed by naltrexone 4.5 mg open labeled
470996|NCT00663117|O1|Outcome|Placebo|Placebo for 12 weeks blinded followed by naltrexone 4.5mg open labeled
470997|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Quality of life on naltrexone treatment 12 weeks
470998|NCT00663117|O1|Outcome|Placebo|Quality of life in subjects on placebo treatment for 12 weeks
470999|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Naltrexone treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
471263|NCT00657553|B2|Baseline|Observation Arm|Patients will be observed for progress over the course of three years.
471000|NCT00663117|O1|Outcome|Placebo|Placebo treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
471001|NCT00663117|E2|Reported Event|Naltrexone 4.5 mg|All participants who received naltrexone either for 12 or 24 weeks.
471002|NCT00663117|E1|Reported Event|Placebo|Participants who received placebo for the first 12 weeks.
471003|NCT00663169|B3|Baseline|Total|Total of all reporting groups
471004|NCT00663169|B2|Baseline|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471005|NCT00663169|B1|Baseline|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471006|NCT00663169|P2|Participant Flow|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471007|NCT00663169|P1|Participant Flow|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471008|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471009|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471010|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471011|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471012|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471013|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471014|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471015|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471016|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471017|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471018|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471019|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471020|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471021|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471022|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471023|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471024|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471025|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471026|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471027|NCT00663169|E2|Reported Event|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
471028|NCT00663169|E1|Reported Event|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
471029|NCT00663208|B8|Baseline|Total|Total of all reporting groups
471030|NCT00663208|B7|Baseline|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471031|NCT00663208|B6|Baseline|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471032|NCT00663208|B5|Baseline|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471033|NCT00663208|B4|Baseline|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471034|NCT00663208|B3|Baseline|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471035|NCT00663208|B2|Baseline|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471036|NCT00663208|B1|Baseline|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471037|NCT00663208|P7|Participant Flow|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471038|NCT00663208|P6|Participant Flow|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471039|NCT00663208|P5|Participant Flow|Daclatasvir (30 mg) BID|Participants received twice daily (BID) dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471040|NCT00663208|P4|Participant Flow|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471071|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471041|NCT00663208|P3|Participant Flow|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471042|NCT00663208|P2|Participant Flow|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471043|NCT00663208|P1|Participant Flow|Daclatasvir (1 mg) QD|Participants received once daily (QD) dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471044|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471045|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471046|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471047|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471048|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471049|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471050|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471051|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471052|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471053|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471054|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471055|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471056|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471057|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471058|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471059|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471060|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471061|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471062|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471063|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471064|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471065|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471066|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471498|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471067|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471068|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471069|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471070|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471072|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471073|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471074|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471075|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471076|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471077|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471078|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471079|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471080|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471081|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471082|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471083|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471084|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471085|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471086|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471087|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471088|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471089|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471090|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471091|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471092|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471093|NCT00663208|O1|Outcome|All Daclatasvir Treated Participants|All participants who received daclatasvir during 14 day treatment period.
471094|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471095|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471096|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471097|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471098|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471099|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471100|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471101|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471102|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471103|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471104|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471105|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471106|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471107|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471108|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471109|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471110|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471111|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471112|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471113|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471114|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471115|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471116|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471117|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471118|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471119|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471120|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471121|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471122|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471123|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471124|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471125|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471126|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471127|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471128|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471129|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471130|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471131|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471132|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471133|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471134|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471135|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471136|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471137|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471138|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471139|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471140|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471141|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471142|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471143|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471144|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471145|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471146|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471147|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471148|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471149|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471150|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471151|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471152|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471153|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471154|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471155|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471156|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471157|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471158|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471299|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ(Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471159|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471160|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471161|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471162|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471163|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471164|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471165|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471166|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471167|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182..
471168|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471169|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471170|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471171|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471172|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471173|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471174|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471175|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471176|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471177|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471178|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471179|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471180|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471181|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471182|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471183|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471184|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471185|NCT00663208|E7|Reported Event|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
471186|NCT00663208|E6|Reported Event|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471187|NCT00663208|E5|Reported Event|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471188|NCT00663208|E4|Reported Event|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471499|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471189|NCT00663208|E3|Reported Event|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471190|NCT00663208|E2|Reported Event|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471191|NCT00663208|E1|Reported Event|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received Daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
471192|NCT00663234|B1|Baseline|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471193|NCT00663234|P1|Participant Flow|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage starts at 10 mg and is increased to 20 mg at week 8 if efficacy criteria is not met at week 4.
471400|NCT00665431|B1|Baseline|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471194|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
471195|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
471196|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
471197|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
471198|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471199|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471200|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471201|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471202|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471203|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471204|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471205|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471206|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471207|NCT00663234|O2|Outcome|NNRTI-unexposed|Participant was not on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
471208|NCT00663234|O1|Outcome|NNRTI-exposed|Participant was on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
471209|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
471210|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
471211|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471212|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471213|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471214|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471215|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471216|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471217|NCT00663234|E1|Reported Event|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
471218|NCT00663260|B4|Baseline|Total|Total of all reporting groups
471219|NCT00663260|B3|Baseline|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
471220|NCT00663260|B2|Baseline|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
471221|NCT00663260|B1|Baseline|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
471222|NCT00663260|P3|Participant Flow|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
471223|NCT00663260|P2|Participant Flow|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
471224|NCT00663260|P1|Participant Flow|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
471500|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471225|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
471226|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
471227|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
471228|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
473945|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
471229|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
471230|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
471231|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
471232|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
471233|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
471234|NCT00663260|E3|Reported Event|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
471235|NCT00663260|E2|Reported Event|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
471236|NCT00663260|E1|Reported Event|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
471237|NCT00657267|B1|Baseline|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
471238|NCT00657267|P1|Participant Flow|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
471239|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
471240|NCT00657267|O2|Outcome|Complete Response|Complete responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
471241|NCT00657267|O1|Outcome|Partial Response|Partial Responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
471242|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
471243|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
471244|NCT00657267|E1|Reported Event|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|All 58 participants who started treatment: Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets
471245|NCT00657280|B1|Baseline|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
471246|NCT00657280|P1|Participant Flow|Sitagliptin|There is only one group. All the participants took Sitagliptin 100mg daily and acted as their own controls
471247|NCT00657280|O1|Outcome|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
471248|NCT00657280|E1|Reported Event|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
471249|NCT00657358|B1|Baseline|Lidocaine|Healthy Volunteers receiving Lidocaine
471250|NCT00657358|P1|Participant Flow|Lidocaine|Healthy Volunteers receiving Lidocaine
471251|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
471252|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
471253|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
471254|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.infused within 20 minutes.
471501|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471255|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
471256|NCT00657358|E1|Reported Event|Lidocaine|Healthy Volunteers receiving Lidocaine
471257|NCT00657371|B1|Baseline|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
471258|NCT00657371|P1|Participant Flow|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
471259|NCT00657371|O1|Outcome|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
471260|NCT00657371|O1|Outcome|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
471261|NCT00657371|E1|Reported Event|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
471262|NCT00657553|B3|Baseline|Total|Total of all reporting groups
473946|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
471264|NCT00657553|B1|Baseline|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
471265|NCT00657553|P2|Participant Flow|Observation Arm|Patients will be observed for progress over the course of three years.
471266|NCT00657553|P1|Participant Flow|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
471267|NCT00657553|O2|Outcome|Observation Arm|Patients will be observed for progress over the course of three years.
471268|NCT00657553|O1|Outcome|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
471269|NCT00657553|E2|Reported Event|Observation Arm|Patients will be observed for progress over the course of three years.
471270|NCT00657553|E1|Reported Event|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
471271|NCT00657657|B1|Baseline|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
471272|NCT00657657|P1|Participant Flow|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
471273|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
471274|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
471275|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
471276|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
471277|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
471278|NCT00657657|E1|Reported Event|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
471279|NCT00657709|B6|Baseline|Total|Total of all reporting groups
471280|NCT00657709|B5|Baseline|MenC+ Routine|Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
471281|NCT00657709|B4|Baseline|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471282|NCT00657709|B3|Baseline|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471283|NCT00657709|B2|Baseline|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471284|NCT00657709|B1|Baseline|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471285|NCT00657709|P5|Participant Flow|MenC+ Routine|Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
471286|NCT00657709|P4|Participant Flow|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471287|NCT00657709|P3|Participant Flow|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471288|NCT00657709|P2|Participant Flow|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471289|NCT00657709|P1|Participant Flow|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471290|NCT00657709|O2|Outcome|MenC+Routine|Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
471291|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471292|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471293|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471294|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471295|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ(Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471296|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471297|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471298|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot2, or Lot3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471300|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471301|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ(Lot1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471302|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471303|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471304|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471305|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
473947|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
471306|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471307|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471308|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471309|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection fo rMenB+OMV NZ (Lot1, or Lot 2, or Lot 3) at 2, 4, and 6months of age concomitantly with the routinely administered infant vaccines.
471310|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471311|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471312|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471313|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471314|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471315|NCT00657709|O4|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471316|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471317|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471318|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471319|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471320|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471321|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471322|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471323|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471324|NCT00657709|E5|Reported Event|MenC+Routine|Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
471325|NCT00657709|E4|Reported Event|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
471326|NCT00657709|E3|Reported Event|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471327|NCT00657709|E2|Reported Event|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471328|NCT00657709|E1|Reported Event|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
471329|NCT00663403|B1|Baseline|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
471330|NCT00663403|P1|Participant Flow|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
471331|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
471332|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
471502|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471503|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471333|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
471334|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
471378|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471335|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
471336|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
471337|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
471338|NCT00663403|E1|Reported Event|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
471339|NCT00664742|B1|Baseline|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
471340|NCT00664742|P1|Participant Flow|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
471341|NCT00664742|O1|Outcome|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
471342|NCT00664742|O1|Outcome|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
471343|NCT00664742|E1|Reported Event|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
471344|NCT00665002|B1|Baseline|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
471345|NCT00665002|P1|Participant Flow|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
471346|NCT00665002|O1|Outcome|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
471347|NCT00665002|O1|Outcome|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
471348|NCT00665002|E1|Reported Event|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks.
471349|NCT00665132|B1|Baseline|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System
StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
471350|NCT00665132|P1|Participant Flow|StimRouter Stimulation|"Percutaneous implantation of StimRouter System
StimRouter System: Patient is Implanted with StimRouter System lead and receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
471351|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System
StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
471352|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System
StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
471353|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System
StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
471354|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System
StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
471355|NCT00665132|E1|Reported Event|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System
StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
471356|NCT00665353|B1|Baseline|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
471357|NCT00665353|P1|Participant Flow|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
471358|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
471359|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
471396|NCT00665366|E1|Reported Event|Aripiprazole|
471397|NCT00665431|B4|Baseline|Total|Total of all reporting groups
471398|NCT00665431|B3|Baseline|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471360|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
471361|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
471362|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
471363|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
471364|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
471365|NCT00665353|E1|Reported Event|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
471366|NCT00665366|B3|Baseline|Total|Total of all reporting groups
471367|NCT00665366|B2|Baseline|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471368|NCT00665366|B1|Baseline|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471369|NCT00665366|P2|Participant Flow|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471370|NCT00665366|P1|Participant Flow|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471371|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471372|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471373|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471374|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471375|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471376|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471444|NCT00665444|P1|Participant Flow|Aripiprazole|"Aripiprazole
Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
471377|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471379|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471380|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471381|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471382|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471383|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471384|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471385|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471386|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471387|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471388|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471389|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471390|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471391|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471392|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471485|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471486|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471487|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471393|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
471394|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
471395|NCT00665366|E2|Reported Event|Placebo|
471401|NCT00665431|P3|Participant Flow|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471402|NCT00665431|P2|Participant Flow|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471403|NCT00665431|P1|Participant Flow|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471404|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471405|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471406|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471407|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471408|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471409|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471410|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471411|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471412|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471413|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471414|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471415|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471416|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471417|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471418|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471419|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471420|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471421|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471422|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471423|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471424|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471425|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471426|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471427|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471428|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471429|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471430|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471431|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471432|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471433|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471434|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471435|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471436|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471437|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471438|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471439|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471440|NCT00665431|E3|Reported Event|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
471441|NCT00665431|E2|Reported Event|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
471442|NCT00665431|E1|Reported Event|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
471443|NCT00665444|B1|Baseline|Aripiprazole|"Aripiprazole
Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
471488|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471489|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471490|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471491|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471445|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole
Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
471446|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole
Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
471512|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471513|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471514|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
473948|NCT00669396|E2|Reported Event|Levonorgestrel|Oral levonorgestrel
471447|NCT00665444|E1|Reported Event|Aripiprazole|"Aripiprazole
Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
471448|NCT00665470|B3|Baseline|Total|Total of all reporting groups
471449|NCT00665470|B2|Baseline|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
471450|NCT00665470|B1|Baseline|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
471451|NCT00665470|P2|Participant Flow|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
471452|NCT00665470|P1|Participant Flow|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
471453|NCT00665470|O2|Outcome|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
471454|NCT00665470|O1|Outcome|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
471455|NCT00665470|O2|Outcome|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
471456|NCT00665470|O1|Outcome|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
471457|NCT00665470|E2|Reported Event|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
471458|NCT00665470|E1|Reported Event|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
471459|NCT00665626|B3|Baseline|Total|Total of all reporting groups
471460|NCT00665626|B2|Baseline|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471461|NCT00665626|B1|Baseline|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471462|NCT00665626|P2|Participant Flow|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471463|NCT00665626|P1|Participant Flow|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471464|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471465|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471466|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471467|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471468|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471469|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471470|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471471|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471472|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471473|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471474|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471475|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471476|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471477|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471478|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471479|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471480|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471481|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471482|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471483|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471484|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471504|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471505|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471506|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471507|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471508|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471509|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471510|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471511|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
472138|NCT00666263|O1|Outcome|End of Stabilization 1|(IGIV, 10%)
471515|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471516|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471517|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471518|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471519|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471520|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471521|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471522|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471523|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471524|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471525|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471526|NCT00665626|E2|Reported Event|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471527|NCT00665626|E1|Reported Event|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
471528|NCT00665704|B1|Baseline|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website
Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
471529|NCT00665704|P1|Participant Flow|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website
Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
471530|NCT00665704|O1|Outcome|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website
Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
471531|NCT00665704|O1|Outcome|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website
Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
471532|NCT00665704|E1|Reported Event|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website
Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
471533|NCT00665847|B1|Baseline|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
471534|NCT00665847|P1|Participant Flow|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
471535|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
471536|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
471537|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
471538|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
471539|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
471540|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
471541|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
471542|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
471543|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
471544|NCT00665847|E1|Reported Event|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
471545|NCT00665925|B5|Baseline|Total|Total of all reporting groups
471546|NCT00665925|B4|Baseline|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471547|NCT00665925|B3|Baseline|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471548|NCT00665925|B2|Baseline|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471549|NCT00665925|B1|Baseline|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471550|NCT00665925|P4|Participant Flow|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471551|NCT00665925|P3|Participant Flow|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471552|NCT00665925|P2|Participant Flow|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471553|NCT00665925|P1|Participant Flow|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471554|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471555|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471556|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471557|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471558|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471559|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471560|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471561|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471562|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471563|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471564|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471565|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471566|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471567|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471568|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471569|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471570|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471571|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471572|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471573|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471574|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471575|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471576|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471577|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471578|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471579|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471580|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471581|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471582|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471583|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471584|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471585|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471586|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471587|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471588|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471589|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471590|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471591|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471592|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471593|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471594|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471595|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471596|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471597|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471598|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471599|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471600|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471601|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471602|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471603|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471604|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471605|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471606|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471607|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471608|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471609|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471610|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471611|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471612|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471613|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471614|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471615|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471616|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471617|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471618|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471619|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471620|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471621|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471622|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471623|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471624|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471625|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471626|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471627|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471628|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471629|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471630|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471631|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471632|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471633|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471634|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471635|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471636|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471637|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471638|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471639|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471640|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471641|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471642|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471643|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471644|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471645|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471646|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471647|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471648|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471649|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471650|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471651|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471652|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471653|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471654|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471655|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471656|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471657|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471658|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471659|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471660|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471661|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471662|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471663|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471664|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471665|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471666|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471667|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471668|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471669|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471670|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471671|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471672|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471673|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471674|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471675|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471676|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471677|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471678|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471679|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471680|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471681|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471682|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471683|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471684|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471685|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471686|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471687|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471688|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471689|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471690|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471691|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471692|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471693|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471694|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471695|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471696|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471697|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471698|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471699|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471700|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471701|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471702|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471703|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471704|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471705|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471706|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471707|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471708|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471709|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471710|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471711|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471712|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471713|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471714|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471715|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471716|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471717|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471718|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471719|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471720|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471721|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471722|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471723|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471724|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471725|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471726|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471727|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471728|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471729|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471730|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471731|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471732|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471733|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471734|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471735|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471736|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471737|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471738|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471739|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471740|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471741|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471742|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471743|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471744|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471745|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471746|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471747|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471748|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471749|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471750|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471751|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471752|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471753|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471754|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471755|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471756|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471757|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471758|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471759|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471760|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471761|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471762|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471763|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471764|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471765|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471766|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471767|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471768|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471769|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471770|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471771|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471772|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471773|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471774|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471775|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471776|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471777|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471778|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471779|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471780|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471781|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471782|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471783|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471784|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471785|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471786|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471787|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471788|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471789|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471790|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471791|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471792|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471793|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471794|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471795|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471796|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471797|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471798|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471799|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471800|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471801|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471802|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471803|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471804|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471805|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471806|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471807|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471808|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471809|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471810|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471811|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471812|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471813|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471814|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471815|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471816|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471817|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471818|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471819|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471820|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471821|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471822|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471823|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471824|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471825|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471826|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471827|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471828|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471829|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471830|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471831|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471832|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471833|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471834|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471835|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471836|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471837|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471838|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471839|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471840|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471841|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471842|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471843|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471844|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471845|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471846|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471847|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471848|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471849|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471850|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471851|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471852|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471853|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471854|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471855|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471856|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471857|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471858|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471859|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471860|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471861|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471862|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471863|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471864|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471865|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471866|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471867|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471868|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471869|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471870|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471871|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471872|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471873|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471874|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471875|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471876|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471877|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471878|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471879|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471880|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471881|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471882|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471883|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471884|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471885|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471886|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471887|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471888|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471889|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471890|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471891|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471892|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471893|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471894|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471895|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471896|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471897|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471898|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471899|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471900|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471901|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471902|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471903|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471904|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471905|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471906|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471907|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471908|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471909|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471910|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471911|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471912|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471913|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471914|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471915|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471916|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471917|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471918|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471919|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471920|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471921|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471922|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471923|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471924|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471925|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471926|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471927|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471928|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471929|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471930|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471931|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471932|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471933|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471934|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471935|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471936|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471937|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471938|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471939|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471940|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471941|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471942|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471943|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471944|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471945|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471946|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471947|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471948|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471949|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471950|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471951|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471952|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471953|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471954|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471955|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471956|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
471957|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471958|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471959|NCT00665925|E4|Reported Event|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
471960|NCT00665925|E3|Reported Event|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
471961|NCT00665925|E2|Reported Event|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
471962|NCT00665925|E1|Reported Event|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
471963|NCT00666029|B3|Baseline|Total|Total of all reporting groups
471964|NCT00666029|B2|Baseline|Placebo|"Placebo arm dummy pill
placebo: Placebo Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with > 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides >2.0 mmol/L – a cardinal lipid abnormality of the syndrome."
471965|NCT00666029|B1|Baseline|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.
atorvastatin: 40 m.g. o.d. tablets for 6 months Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with > 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides >2.0 mmol/L – a cardinal lipid abnormality of the syndrome."
471966|NCT00666029|P2|Participant Flow|Placebo|"Placebo arm dummy pill
placebo: Placebo"
471967|NCT00666029|P1|Participant Flow|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.
Participants randomised to atorvastatin: 40 m.g. o.d. tablets for 6 months"
471968|NCT00666029|O2|Outcome|Placebo|"Placebo arm dummy pill
placebo: Placebo"
471969|NCT00666029|O1|Outcome|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.
Participants randomised to atorvastatin: 40 m.g. o.d. tablets for 6 months"
471970|NCT00666029|O2|Outcome|Placebo|"Placebo arm dummy pill
placebo: Placebo"
471971|NCT00666029|O1|Outcome|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.
atorvastatin: 40 m.g. o.d. tablets for 6 months"
471972|NCT00666029|E2|Reported Event|Placebo|"Placebo arm dummy pill
placebo: Placebo"
471973|NCT00666029|E1|Reported Event|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.
atorvastatin: 40 m.g. o.d. tablets for 6 months"
471974|NCT00666198|B1|Baseline|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471975|NCT00666198|P1|Participant Flow|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471976|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471977|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471978|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471979|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471980|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471981|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471982|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471983|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471984|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471985|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471986|NCT00666198|E1|Reported Event|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
471987|NCT00666211|B3|Baseline|Total|Total of all reporting groups
471988|NCT00666211|B2|Baseline|Opioid Titration|Pain will be Monitored and Medication Titrated
471989|NCT00666211|B1|Baseline|Standard of Care|Standard pain control drugs.
471990|NCT00666211|P2|Participant Flow|Opioid Titration|Pain will be Monitored and Medication Titrated
471991|NCT00666211|P1|Participant Flow|Standard of Care|Standard pain control drugs.
471992|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
471993|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
471994|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
471995|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
471996|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
471997|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
471998|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
471999|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
472000|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
472001|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
472002|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
472003|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
472004|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
472005|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
472006|NCT00666211|E2|Reported Event|Opioid Titration|Pain will be Monitored and Medication Titrated
472007|NCT00666211|E1|Reported Event|Standard of Care|Standard pain control drugs.
472008|NCT00666224|B3|Baseline|Total|Total of all reporting groups
472009|NCT00666224|B2|Baseline|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
472010|NCT00666224|B1|Baseline|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
472011|NCT00666224|P2|Participant Flow|Placebo (DB) to GA (OL)|Placebo matching glatiramer acetate given once daily by subcutaneous injection during the double-blind period (DB). Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Glatiramer acetate (GA) given 20 mg once daily by subcutaneous injection during the open-label period (OL).
472012|NCT00666224|P1|Participant Flow|Glatiramer Acetate|Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection during the double-blind period. Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Participants in this treatment arm continued taking glatiramer acetate 20 mg once daily by subcutaneous injection during the open-label (OL) period.
472013|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
472014|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
472015|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
472016|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
472017|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
472018|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
472019|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
472020|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
474755|NCT00671970|O1|Outcome|Who Grade III|Who Grade III Malignant Glioma
472021|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
472022|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
472023|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
472024|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
472025|NCT00666224|E3|Reported Event|Glatiramer Acetate (Entire Study)|Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection. GA adverse experiences from both the double-blind and open-label periods are combined in this column.
472026|NCT00666224|E2|Reported Event|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period. This subset of the GA treatment experience allows for comparison to the Placebo Double-blind Period data.
473949|NCT00669396|E1|Reported Event|Copper T380 IUD|IUD
472027|NCT00666224|E1|Reported Event|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
472028|NCT00666263|B1|Baseline|All Study Participants|"Each participant was to complete 5 study parts (3 stabilization phases of open label treatment with IGIV, 10%, and 1 cross-over period each of double-blind treatment with IGIV, 10% and placebo according to a randomized sequence). Each study part lasted 12 weeks and comprised 3, 4 or 6 infusion cycles depending on treatment interval.
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) for all participants Study Part 2: Participants were randomized to 1 of 2 sequences of double-blind treatment (either: IGIV, 10% or placebo) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Participants were crossed-over to second sequence of double-blind treatment (IGIV, 10% or placebo) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)"
472029|NCT00666263|P2|Participant Flow|Placebo Then IGIV, 10% (During Cross-Over Periods)|Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)
472030|NCT00666263|P1|Participant Flow|IGIV, 10% Then Placebo (During Cross-Over Periods)|Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)
472031|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472032|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472033|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472034|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472119|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
472035|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472139|NCT00666263|O4|Outcome|No Accelerated Switch During IGIV, 10% or Placebo|Participants who did not require a switch to open label IGIV, 10% when receiving IGIV, 10%, or placebo
472140|NCT00666263|O3|Outcome|Accelerated Switch During IGIV, 10%, But Not Placebo|Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, but not during placebo
474015|NCT00669903|B4|Baseline|Placebo|Placebo
472036|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472037|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472038|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472039|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472040|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472041|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472042|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472043|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472120|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
472121|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
472122|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
472123|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
472124|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
472125|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
472044|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472045|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472046|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472047|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472048|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472049|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472050|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472051|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472052|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472126|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
472127|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
474756|NCT00671970|O2|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
472053|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472054|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472055|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472056|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472057|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472058|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472059|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472060|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472061|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472128|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
472129|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
472130|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
472131|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
472132|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
472062|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472063|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472064|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472065|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472066|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472067|NCT00666263|O4|Outcome|No Deterioration After IGIV, 10% or Placebo|Participants with no deterioration in GNDS scores after IGIV, 10% or Placebo
472068|NCT00666263|O3|Outcome|Deterioration After IGIV, 10%, But Not Placebo|Participants with deterioration in GNDS scores after IGIV, 10%, but not Placebo
472069|NCT00666263|O2|Outcome|Deterioration After Placebo, But Not IGIV, 10%|Participants with deterioration in GNDS scores after Placebo, but not IGIV, 10%
472070|NCT00666263|O1|Outcome|Deterioration After IGIV, 10% and Placebo|Participants with deterioration in GNDS scores after IGIV, 10% and placebo
472071|NCT00666263|O4|Outcome|No Decline During Placebo and IGIV, 10%|Participants who did not experience a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
472072|NCT00666263|O3|Outcome|Decline During Both Placebo and IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
472073|NCT00666263|O2|Outcome|Decline Only During Placebo|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following the placebo, but not after IGIV, 10%
472074|NCT00666263|O1|Outcome|Decline Only During IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, but not after the placebo
472075|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
472076|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
472077|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
472078|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
472079|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
472080|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
472081|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
472082|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472191|NCT00666276|O1|Outcome|Linezolid-male|Male participants who have been treated with Linezolid.
472192|NCT00666276|O1|Outcome|Linezolid|Participants who have been treated with Linezolid.
472083|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472084|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472085|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472086|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
472087|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
472088|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
472089|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
472090|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
472091|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
472092|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
472093|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472094|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472095|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472096|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472097|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
472098|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
472099|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
472100|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
472101|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
472102|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
472103|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
472104|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472105|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472106|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472107|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472108|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
472109|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
472110|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
472111|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
472112|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
472113|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
472114|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
472115|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472116|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472117|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472118|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472193|NCT00666276|O1|Outcome|Linezolid|Participants who have been treated with Linezolid.
472194|NCT00666276|E1|Reported Event|Linezolid|Participants who have been treated with Linezolid.
472133|NCT00666263|O6|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
472134|NCT00666263|O5|Outcome|End of Stabilization 3|(IGIV, 10%)
472135|NCT00666263|O4|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
472136|NCT00666263|O3|Outcome|End of Stabilization 2|(IGIV, 10%)
472137|NCT00666263|O2|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
472141|NCT00666263|O2|Outcome|Accelerated Switch During Placebo, But Not IGIV, 10%|Participants who required a switch to open label IGIV, 10% when receiving the placebo, but not during IGIV, 10%
472142|NCT00666263|O1|Outcome|Accelerated Switch During IGIV, 10% and Placebo|Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, and placebo
472143|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472144|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472145|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472146|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472147|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
472148|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
472149|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
472150|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
472151|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
472152|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
472153|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
472154|NCT00666263|O4|Outcome|No Decline During Placebo or IGIV, 10%|Participants who did not experience a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
472155|NCT00666263|O3|Outcome|Decline During Both Placebo and IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
472156|NCT00666263|O2|Outcome|Decline Only During Placebo|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following the placebo, but not after IGIV, 10%
472157|NCT00666263|O1|Outcome|Decline Only During IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, but not after the placebo
472195|NCT00666328|B1|Baseline|Clevidipine|"mITT (Modified Intent To Treat) Population (n=33): This population is the primary population for the efficacy analyses.
Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range."
472158|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10% - Crossover Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472197|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
472159|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10% - Crossover Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472160|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Crossover Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472161|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- Crossover Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
472162|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
472163|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
472164|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
472165|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
472166|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
472167|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
472168|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
472169|NCT00666263|E2|Reported Event|Placebo|0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used)
472170|NCT00666263|E1|Reported Event|IGIV, 10%|Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle)
472171|NCT00666276|B1|Baseline|Linezolid|Participants who have been treated with Linezolid.
472172|NCT00666276|P1|Participant Flow|Linezolid|Participants who have been treated with Linezolid.
472173|NCT00666276|O2|Outcome|Linezolid-with Non-drug Therapies|Participants with Non-drug therapies who have been treated with Linezolid.
472174|NCT00666276|O1|Outcome|Linezolid-without Non-drug Therapies|Participants without Non-drug therapies who have been treated with Linezolid.
472175|NCT00666276|O2|Outcome|Linezolid-with Concomitant Drugs|Participants with Concomitant drugs who have been treated with Linezolid.
472176|NCT00666276|O1|Outcome|Linezolid-without Concomitant Drugs|Participants without Concomitant drugs who have been treated with Linezolid.
472177|NCT00666276|O2|Outcome|Linezolid -Less Than 40kg|Participants less than 40kg who have been treated with Linezolid.
472178|NCT00666276|O1|Outcome|Linezolid -Over 40kg|Participants over 40kg who have been treated with Linezolid.
472179|NCT00666276|O3|Outcome|Linezolid-oral From Injection|Participants with who have been treated with Linezolid by orally from injection .
472180|NCT00666276|O2|Outcome|Linezolid-injection|Participants with who have been treated with Linezolid by injection.
472181|NCT00666276|O1|Outcome|Linezolid-oral|Participants with who have been orally treated with Linezolid.
472182|NCT00666276|O2|Outcome|Linezolid-administrated Less Than 15 Days|Participants with who have been treated with Linezolid.with Duration of drug administration less than 15 days
472183|NCT00666276|O1|Outcome|Linezolid-administrated Over 15 Days|Participants who have been treated with Linezolid.with Duration of drug administration over 15 days
472184|NCT00666276|O2|Outcome|Linezolid- With Renal Dysfunctions|Participants with Renal dysfunctions who have been treated with Linezolid.
472185|NCT00666276|O1|Outcome|Linezolid Without Renal Dysfunctions|Participants without Renal dysfunctions who have been treated with Linezolid.
472186|NCT00666276|O2|Outcome|Linezolid- With Hepatic Dysfunctions|Participants with Hepatic dysfunctions who have been treated with Linezolid.
472187|NCT00666276|O1|Outcome|Linezolid-without Hepatic Dysfunctions|Participants with or without Hepatic dysfunctions who have been treated with Linezolid.
472188|NCT00666276|O2|Outcome|Linezolid-less Than 65|Participants with less than 65 years old who have been treated with Linezolid.
472189|NCT00666276|O1|Outcome|Linezolid-over 65|Participants with over 65 years old who have been treated with Linezolid.
472190|NCT00666276|O2|Outcome|Linezolid-female|Female participants who have been treated with Linezolid.
472196|NCT00666328|P1|Participant Flow|Clevidipine|Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours.
472223|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472224|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472198|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
472199|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
472200|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours
472201|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
472202|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
472203|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for 30 minutes to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range.
472204|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
472205|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
472206|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
472207|NCT00666328|E1|Reported Event|Clevidipine|"Safety Population (n=35): This population is the primary population for the safety analyses.
Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range."
472208|NCT00666406|B1|Baseline|All Study Participants|Includes groups randomized to receive Advate rAHF-PFM and Recombinate rAHF first.
472209|NCT00666406|P2|Participant Flow|Recombinate rAHF Then Advate rAHF-PFM|"First infusion - Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
Second infusion - Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight"
472210|NCT00666406|P1|Participant Flow|Advate rAHF-PFM Then Recombinate rAHF|"First infusion - Advate Antihemophilic Factor (Recombinant)–Plasma/Albumin Free Method (rAHF-PFM): Infusion of 50 +/- 5 IU/kg bodyweight
Second infusion - Recombinate Antihemophilic Factor (Recombinant) (rAHF): Infusion of 50 +/- 5 IU/kg bodyweight"
472211|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472212|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472213|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472214|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472215|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472216|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472217|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472218|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472219|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472220|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472221|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472222|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472225|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472226|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472227|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472228|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472229|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472230|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472231|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472232|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472233|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472234|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472235|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472236|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472237|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472238|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472239|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472240|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472241|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472242|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472243|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472244|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472245|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472246|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472247|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472248|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472249|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472250|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472251|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472252|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472253|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472254|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472255|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472256|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472257|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472258|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472259|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472260|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472261|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472262|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472263|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472264|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472265|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472266|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472267|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472268|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472269|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472270|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472271|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472272|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472273|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472274|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472275|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
474757|NCT00671970|O1|Outcome|Who Grade III|Who Grade III Malignant Glioma
472276|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472277|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472278|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472279|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472280|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472281|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
472282|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
472283|NCT00666406|E1|Reported Event|All Study Participants|Includes groups randomized to receive Advate rAHF-PFM and Recombinate rAHF first.
472284|NCT00666458|B3|Baseline|Total|Total of all reporting groups
472285|NCT00666458|B2|Baseline|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
472286|NCT00666458|B1|Baseline|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
472287|NCT00666458|P2|Participant Flow|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
472288|NCT00666458|P1|Participant Flow|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
472289|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
472290|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
472291|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
472292|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
472293|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
472294|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
472295|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
472296|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
472297|NCT00666458|E2|Reported Event|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
472298|NCT00666458|E1|Reported Event|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
472299|NCT00666536|B3|Baseline|Total|Total of all reporting groups
472300|NCT00666536|B2|Baseline|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472301|NCT00666536|B1|Baseline|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472302|NCT00666536|P2|Participant Flow|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472303|NCT00666536|P1|Participant Flow|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472304|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472305|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472306|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472307|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472308|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472309|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472310|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472311|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472312|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472313|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472314|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472411|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
472315|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472316|NCT00666536|E2|Reported Event|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472317|NCT00666536|E1|Reported Event|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
472318|NCT00666562|B4|Baseline|Total|Total of all reporting groups
472319|NCT00666562|B3|Baseline|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472320|NCT00666562|B2|Baseline|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472321|NCT00666562|B1|Baseline|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472322|NCT00666562|P3|Participant Flow|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472323|NCT00666562|P2|Participant Flow|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472324|NCT00666562|P1|Participant Flow|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472325|NCT00666562|O4|Outcome|7/7 Genotype|Genotype of the UGT in EGCG
472326|NCT00666562|O3|Outcome|6/7 Genotype|Genotype of the UGT in EGCG
472327|NCT00666562|O2|Outcome|6/6 Genotype|Genotype of the UGT in EGCG
472328|NCT00666562|O1|Outcome|5/6 Genotype|Genotype of the UGT in EGCG
472329|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472330|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472331|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472332|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472405|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
472406|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
472333|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472334|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472412|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
472413|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
472335|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472336|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472337|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472338|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472339|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472340|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472341|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472342|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472343|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472344|NCT00666562|O3|Outcome|Alanine/Alanine|A to A transition in the COMT gene
472345|NCT00666562|O2|Outcome|Alanine/Glycine|A to G transition in the COMT gene
472346|NCT00666562|O1|Outcome|Glycine/Glycine|G to G transition in the COMT gene
472347|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472348|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472349|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472350|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472351|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472407|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
472352|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472353|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472354|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472355|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472356|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472357|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472358|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472359|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472360|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472361|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472362|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472363|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472364|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472365|NCT00666562|E3|Reported Event|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472366|NCT00666562|E2|Reported Event|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472367|NCT00666562|E1|Reported Event|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
472368|NCT00666588|B5|Baseline|Total|Total of all reporting groups
472408|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
472409|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
472410|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
472369|NCT00666588|B4|Baseline|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472414|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
472370|NCT00666588|B3|Baseline|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472371|NCT00666588|B2|Baseline|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472372|NCT00666588|B1|Baseline|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.
idarubicin: Given IV
cytarabine: Given IV or IT
bortezomib: Given IV
laboratory biomarker analysis: Correlative studies"
472373|NCT00666588|P4|Participant Flow|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472374|NCT00666588|P3|Participant Flow|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472375|NCT00666588|P2|Participant Flow|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472376|NCT00666588|P1|Participant Flow|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.
idarubicin: Given IV
cytarabine: Given IV or IT
bortezomib: Given IV
laboratory biomarker analysis: Correlative studies"
472377|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472387|NCT00666588|E2|Reported Event|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472415|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
472416|NCT00666679|E2|Reported Event|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
472417|NCT00666679|E1|Reported Event|Montelukast + Mometasone|Inhaled montelukast 1 mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
472457|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
472378|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472379|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472380|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.
idarubicin: Given IV
cytarabine: Given IV or IT
bortezomib: Given IV
laboratory biomarker analysis: Correlative studies"
472381|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472382|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472383|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472384|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.
idarubicin: Given IV
cytarabine: Given IV or IT
bortezomib: Given IV
laboratory biomarker analysis: Correlative studies"
472385|NCT00666588|E4|Reported Event|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472386|NCT00666588|E3|Reported Event|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).
cytarabine: Given IV or IT
bortezomib: Given IV
etoposide: Given IV
laboratory biomarker analysis: Correlative studies"
472401|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
472402|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
472403|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
472404|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
474758|NCT00671970|E1|Reported Event|All Patients|All Patients
472388|NCT00666588|E1|Reported Event|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.
idarubicin: Given IV
cytarabine: Given IV or IT
bortezomib: Given IV
laboratory biomarker analysis: Correlative studies"
472389|NCT00666666|B1|Baseline|AT101 (R-(-)-Gossypol Acetic Acid)|
472390|NCT00666666|P1|Participant Flow|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
472391|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
472392|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
472393|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
472394|NCT00666666|E1|Reported Event|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
472395|NCT00666679|B3|Baseline|Total|Total of all reporting groups
472396|NCT00666679|B2|Baseline|Placebo + Mometasone Then Montelukast + Mometasone|Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
472397|NCT00666679|B1|Baseline|Montelukast + Mometasone Then Placebo + Mometasone|Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
472398|NCT00666679|P2|Participant Flow|Placebo + Mometasone Then Montelukast + Mometasone|Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
472399|NCT00666679|P1|Participant Flow|Montelukast + Mometasone Then Placebo + Mometasone|Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
472400|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
472418|NCT00666705|B1|Baseline|Maraviroc / Raltegravir (Alone and Co-administered)|"All subjects received the following fixed sequence study treatments:
Days 1-3: raltegravir 400 mg every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14)."
472419|NCT00666705|P1|Participant Flow|Maraviroc / Raltegravir (Alone and Co-administered)|"All subjects received the following fixed sequence study treatments:
Days 1-3: raltegravir 400 milligrams (mg) every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14)."
472420|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
472421|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
472422|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
472423|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
472424|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
472425|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
472426|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
472427|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
472428|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
472429|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
472430|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
472431|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
472432|NCT00666705|E3|Reported Event|Raltegravir|400 milligrams (mg) every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
472433|NCT00666705|E2|Reported Event|Maraviroc + Raltegravir|On Study Days 12-14: Raltegravir 400 milligrams (mg) every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
472434|NCT00666705|E1|Reported Event|Maraviroc|300 milligrams (mg) every 12 hours on Study Days 6-11
472435|NCT00666718|B3|Baseline|Total|Total of all reporting groups
472436|NCT00666718|B2|Baseline|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
472437|NCT00666718|B1|Baseline|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin
472438|NCT00666718|P2|Participant Flow|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
472439|NCT00666718|P1|Participant Flow|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin
472440|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
472441|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
472442|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
472443|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
472444|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
472445|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
472446|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
472447|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
472448|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
472449|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
472450|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
472451|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
472452|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
472453|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
472454|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
472455|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
472456|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
472494|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472458|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
472459|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
472460|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
472461|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
472462|NCT00666718|E2|Reported Event|Lispro/Metformin|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
472463|NCT00666718|E1|Reported Event|Glargine/Lispro|Glargine plus Insulin Lispro (2-3 injections) plus metformin
472464|NCT00666757|B3|Baseline|Total|Total of all reporting groups
472465|NCT00666757|B2|Baseline|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472466|NCT00666757|B1|Baseline|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472467|NCT00666757|P2|Participant Flow|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472468|NCT00666757|P1|Participant Flow|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472469|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472470|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472471|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472472|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472473|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472474|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472475|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472476|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472477|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472478|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472479|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472480|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472481|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472482|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472483|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472484|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472485|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472486|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472487|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472488|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472489|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472490|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472491|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472492|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472493|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472495|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472496|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472497|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472498|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472499|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472500|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472501|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472502|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472503|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472504|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472505|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472506|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472507|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472508|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472509|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472510|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472511|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472512|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472513|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472514|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472515|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472516|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472517|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
472518|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
472519|NCT00666757|E5|Reported Event|Sertraline|50-200 mg orally daily for 12 weeks
472520|NCT00666757|E4|Reported Event|Paroxetine|20-50 mg orally daily for 12 weeks
472521|NCT00666757|E3|Reported Event|Fluoxetine|20-80 mg orally daily for 12 weeks
472522|NCT00666757|E2|Reported Event|Citalopram|20-40 mg orally daily for 12 weeks
472523|NCT00666757|E1|Reported Event|Duloxetine|30-120 mg orally daily for 12 weeks
472524|NCT00666835|B3|Baseline|Total|Total of all reporting groups
472525|NCT00666835|B2|Baseline|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated with ERYPO® Janssen-Cilag intravenously in pre-filled syringes (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
474759|NCT00672100|B4|Baseline|Total|Total of all reporting groups
472526|NCT00666835|B1|Baseline|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1. Treatment was done intravenously (solution for injection i.v.) in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
472527|NCT00666835|P2|Participant Flow|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated intravenously with ERYPO®, Janssen-Cilag in pre-filled syringes (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
472528|NCT00666835|P1|Participant Flow|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to epoetin alfa HX575 Hexal AG in ratio 2:1. Treatment was done intravenously (solution for injection i.v.) in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
472529|NCT00666835|O2|Outcome|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated intravenously with ERYPO® Janssen-Cilag in pre-filled syringes (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
472530|NCT00666835|O1|Outcome|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1. Treatment was done intravenously (solution for injection i.v.) in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
472531|NCT00666835|O2|Outcome|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated with ERYPO®, Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
472532|NCT00666835|O1|Outcome|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1. Treatment was done intravenously (solution for injection i.v.) in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
472533|NCT00666835|E2|Reported Event|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated with ERYPO®, Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
472534|NCT00666835|E1|Reported Event|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1 to be intravenously (solution for injection i.v.) treated with HX575 in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
472535|NCT00666848|B4|Baseline|Total|Total of all reporting groups
472536|NCT00666848|B3|Baseline|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
472537|NCT00666848|B2|Baseline|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
472538|NCT00666848|B1|Baseline|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
472539|NCT00666848|P3|Participant Flow|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
472540|NCT00666848|P2|Participant Flow|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
472541|NCT00666848|P1|Participant Flow|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
472542|NCT00666848|O3|Outcome|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
472543|NCT00666848|O2|Outcome|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
472544|NCT00666848|O1|Outcome|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
472545|NCT00666848|O3|Outcome|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
472546|NCT00666848|O2|Outcome|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
472547|NCT00666848|O1|Outcome|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
472548|NCT00666848|E3|Reported Event|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
472549|NCT00666848|E2|Reported Event|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
473087|NCT00667251|E2|Reported Event|Trastuzumab|Plus taxane based chemotherapy.
472550|NCT00666848|E1|Reported Event|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
472551|NCT00666926|B1|Baseline|Entire Study Population|PF-00562271 dose escalation administered as 5 mg PO BID up to 150 mg PO BID or 125 mg PO QD up to 225 mg PO QD. Participants in the PF-00562271125 mg BID US E1 cohort administered MDZ 2 mg/mL as a single dose on C1.D1 and C1.D21 prior to PF-00562271 dosing.
472552|NCT00666926|P16|Participant Flow|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472553|NCT00666926|P15|Participant Flow|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472554|NCT00666926|P14|Participant Flow|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472555|NCT00666926|P13|Participant Flow|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472585|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472556|NCT00666926|P12|Participant Flow|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 (C1.D21) simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ.
Escalation and expansion cohorts were combined for reporting."
472557|NCT00666926|P11|Participant Flow|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472558|NCT00666926|P10|Participant Flow|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort. Escalation and expansion cohorts were combined for reporting.
472559|NCT00666926|P9|Participant Flow|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472560|NCT00666926|P8|Participant Flow|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (expansion cohort).
As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort."
472561|NCT00666926|P7|Participant Flow|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472562|NCT00666926|P6|Participant Flow|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472563|NCT00666926|P5|Participant Flow|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472564|NCT00666926|P4|Participant Flow|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472565|NCT00666926|P3|Participant Flow|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472566|NCT00666926|P2|Participant Flow|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472567|NCT00666926|P1|Participant Flow|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472568|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472569|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472570|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472571|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472572|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472573|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472574|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472575|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472576|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).
As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
472577|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472578|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472579|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472580|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472581|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472582|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472583|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472584|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
473931|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
472586|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472587|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472588|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472589|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472590|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472591|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472592|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).
As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
472593|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472594|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472595|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472596|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472597|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472598|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472599|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472600|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472601|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472602|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472603|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472604|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472605|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472606|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472607|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472608|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).
As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
475233|NCT00673361|E1|Reported Event|"Chemo-Switch Regimen"|
472609|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472610|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472611|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472612|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472613|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472614|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472615|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472616|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472617|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472618|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472619|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472620|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472621|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472622|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472623|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472624|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).
As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
472625|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472626|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472627|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472628|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472629|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472630|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472631|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472632|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472633|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472634|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472635|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472636|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472637|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472638|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472639|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472689|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472640|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).
As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
472641|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472642|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472643|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472644|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472645|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472646|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472647|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472648|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472649|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472650|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472651|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472652|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472653|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472654|NCT00666926|O14|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472655|NCT00666926|O13|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472656|NCT00666926|O12|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472690|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472691|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
476206|NCT00676585|B1|Baseline|Control|Normal Saline
472657|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472658|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472698|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472659|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472660|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472661|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472662|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472663|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472664|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472665|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472666|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472667|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472668|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472669|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472670|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472671|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472672|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472673|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472674|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472675|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472676|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472677|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472678|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472679|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472680|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472681|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472682|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472683|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472684|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472685|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472686|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472687|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472688|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472692|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472693|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472694|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472695|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472696|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472697|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
473932|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
472699|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472700|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472701|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472702|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472703|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472704|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472705|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472706|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472707|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472708|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472709|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472710|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472711|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472712|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472713|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472714|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472715|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472716|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472717|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472718|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472719|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472720|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472721|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472722|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472723|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472724|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472725|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472726|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472727|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
473088|NCT00667251|E1|Reported Event|Lapatinib|Plus taxane based chemotherapy
472728|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472729|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472730|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472731|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472850|NCT00666926|E7|Reported Event|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472851|NCT00666926|E6|Reported Event|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472852|NCT00666926|E5|Reported Event|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472732|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472733|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472734|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472735|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472736|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472737|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472738|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472739|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472740|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472741|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472742|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472743|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472744|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472745|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472746|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472747|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472748|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472749|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472750|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472751|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472752|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472753|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472754|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472755|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472756|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472757|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472758|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472759|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472760|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472761|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472792|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472793|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472794|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472849|NCT00666926|E8|Reported Event|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (expansion cohort).
As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort."
472762|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472763|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472764|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472765|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472766|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472767|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472768|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472769|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472770|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472771|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472772|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472773|NCT00666926|O18|Outcome|PF-00562271 125 mg BID (Expansion Cohort)|"PF-00562271 administered as 125 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472774|NCT00666926|O17|Outcome|PF-00562271 100 mg BID (Expansion Cohort)|PF-00562271 administered as 100 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472775|NCT00666926|O16|Outcome|PF-00562271 75 mg BID (Expansion Cohort)|PF-00562271 administered as 75 mg PO BID with food w/food. As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort.
472776|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472777|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472778|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472779|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472780|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
472781|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472782|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472783|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472784|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472785|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472786|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472787|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472788|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472789|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472790|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472791|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472795|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472796|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472797|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472798|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472799|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472800|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472801|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472802|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472803|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472804|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472805|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472806|NCT00666926|O18|Outcome|PF-00562271 125 mg BID (Expansion Cohort)|"PF-00562271 administered as 125 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472807|NCT00666926|O17|Outcome|PF-00562271 100 mg BID (Expansion Cohort)|PF-00562271 administered as 100 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472808|NCT00666926|O16|Outcome|PF-00562271 75 mg BID (Expansion Cohort)|PF-00562271 administered as 75 mg PO BID with food w/food. As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort.
472809|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472810|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472811|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472812|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472813|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
472814|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472815|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472816|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472817|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472818|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472819|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472820|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472821|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472822|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472823|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472931|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472824|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472825|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472826|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472827|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472828|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472829|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
472830|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472831|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
472832|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472833|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).
As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
472834|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
472835|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
472836|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
472837|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472838|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472839|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472840|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472841|NCT00666926|E16|Reported Event|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
472842|NCT00666926|E15|Reported Event|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
472843|NCT00666926|E14|Reported Event|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
472844|NCT00666926|E13|Reported Event|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
472845|NCT00666926|E12|Reported Event|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ.
Escalation and expansion cohorts were combined for reporting."
472846|NCT00666926|E11|Reported Event|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
472847|NCT00666926|E10|Reported Event|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort. Escalation and expansion cohorts were combined for reporting.
472848|NCT00666926|E9|Reported Event|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
472907|NCT00667095|B2|Baseline|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472932|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473165|NCT00667368|O1|Outcome|Control|Bi-monthly testing for BV without treatment.
472853|NCT00666926|E4|Reported Event|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
472854|NCT00666926|E3|Reported Event|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
472855|NCT00666926|E2|Reported Event|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
472856|NCT00666926|E1|Reported Event|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
472857|NCT00666965|B5|Baseline|Total|Total of all reporting groups
472858|NCT00666965|B4|Baseline|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
472859|NCT00666965|B3|Baseline|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
472860|NCT00666965|B2|Baseline|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
472861|NCT00666965|B1|Baseline|Placebo|placebo transdermal patch
472862|NCT00666965|P4|Participant Flow|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
472863|NCT00666965|P3|Participant Flow|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
472864|NCT00666965|P2|Participant Flow|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
472865|NCT00666965|P1|Participant Flow|Placebo|placebo transdermal patch
472866|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
472867|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
472868|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
472869|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
472870|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
472871|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
472872|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
472873|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
472874|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
472875|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
472876|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
472877|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
472878|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
472879|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
472880|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
472881|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
472882|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
472883|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
472884|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
472885|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
472886|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
472887|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
472888|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
472889|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
472890|NCT00666965|E4|Reported Event|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
472891|NCT00666965|E3|Reported Event|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
472892|NCT00666965|E2|Reported Event|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
472893|NCT00666965|E1|Reported Event|Placebo|placebo transdermal patch
472894|NCT00666978|B3|Baseline|Total|Total of all reporting groups
472895|NCT00666978|B2|Baseline|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
472896|NCT00666978|B1|Baseline|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
472897|NCT00666978|P2|Participant Flow|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
472898|NCT00666978|P1|Participant Flow|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
472899|NCT00666978|O1|Outcome|All Study Participants|All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling.
472900|NCT00666978|O1|Outcome|Bupropion Arm|270 African American adults received bupropion (150mg bid)for 7 weeks in addition to health education counseling.
472901|NCT00666978|O1|Outcome|All Study Participants|All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling.
472902|NCT00666978|O2|Outcome|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
472903|NCT00666978|O1|Outcome|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
472904|NCT00666978|E2|Reported Event|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
472905|NCT00666978|E1|Reported Event|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
472906|NCT00667095|B3|Baseline|Total|Total of all reporting groups
472998|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472908|NCT00667095|B1|Baseline|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472909|NCT00667095|P2|Participant Flow|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472939|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472910|NCT00667095|P1|Participant Flow|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472911|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472912|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472913|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472914|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472915|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472916|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472917|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472918|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472919|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472920|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472921|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472922|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472923|NCT00667095|E2|Reported Event|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472924|NCT00667095|E1|Reported Event|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
472925|NCT00660660|B3|Baseline|Total|Total of all reporting groups
472926|NCT00660660|B2|Baseline|Placebo|Capsule once daily (QD)
472927|NCT00660660|B1|Baseline|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472928|NCT00660660|P2|Participant Flow|Placebo|Capsule once daily (QD)
472929|NCT00660660|P1|Participant Flow|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472930|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473078|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
472933|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472934|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472935|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472936|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472937|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472938|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472940|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472941|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472942|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472943|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472944|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472945|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472946|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472947|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472948|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472949|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472950|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472951|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472952|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472953|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472954|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472955|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472956|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472957|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472958|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472959|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472960|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472961|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472962|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472963|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472964|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472965|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472966|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472967|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472968|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472969|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472970|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472971|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472972|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472973|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472974|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472975|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472976|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472977|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472978|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472979|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472980|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472981|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472982|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472983|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472984|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472985|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472986|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472987|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472988|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472989|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472990|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472991|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472992|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472993|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472994|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472995|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472996|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
472997|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
472999|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473000|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473001|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473002|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473003|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473004|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473005|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473006|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473007|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473008|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473009|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473010|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473011|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473012|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473013|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473014|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473015|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473016|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473017|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473018|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473019|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473020|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473021|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473022|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
473023|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473024|NCT00660660|E2|Reported Event|Placebo|Capsule once daily (QD)
473025|NCT00660660|E1|Reported Event|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
473026|NCT00660699|B1|Baseline|Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473027|NCT00660699|P1|Participant Flow|Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473028|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473029|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473030|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473031|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473032|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473079|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
473033|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473091|NCT00667277|O1|Outcome|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.
bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
473034|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473035|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473036|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473037|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473038|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473039|NCT00660699|E1|Reported Event|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
473040|NCT00667186|B3|Baseline|Total|Total of all reporting groups
473041|NCT00667186|B2|Baseline|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV
Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
473042|NCT00667186|B1|Baseline|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria
Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
473043|NCT00667186|P2|Participant Flow|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV
Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
473044|NCT00667186|P1|Participant Flow|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria
Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
473045|NCT00667186|O2|Outcome|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV
Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
473046|NCT00667186|O1|Outcome|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria
Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
473047|NCT00667186|O2|Outcome|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV
Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
473048|NCT00667186|O1|Outcome|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria
Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
473049|NCT00667186|E2|Reported Event|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV
Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
473050|NCT00667186|E1|Reported Event|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria
Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
473051|NCT00667225|B3|Baseline|Total|Total of all reporting groups
473080|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
473081|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
473052|NCT00667225|B2|Baseline|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
473053|NCT00667225|B1|Baseline|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
473054|NCT00667225|P2|Participant Flow|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
473055|NCT00667225|P1|Participant Flow|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
473056|NCT00667225|O2|Outcome|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
473057|NCT00667225|O1|Outcome|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
473058|NCT00667225|O2|Outcome|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
473059|NCT00667225|O1|Outcome|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
473060|NCT00667225|E2|Reported Event|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
473061|NCT00667225|E1|Reported Event|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
473062|NCT00667251|B3|Baseline|Total|Total of all reporting groups
473063|NCT00667251|B2|Baseline|Trastuzumab|
473064|NCT00667251|B1|Baseline|Lapatinib|
473065|NCT00667251|P2|Participant Flow|Trastuzumab|Trastuzumab ng- IV weekly (loading dose 4 mg/kg, subsequent doses 2 mg/kg) Paclitaxel - 80 mg/m2 IV weekly (days 1, 8 and 15 of a 4-week cycle). or Trastuzumab - IV weekly (loading dose 8 mg/kg, subsequent doses 6 mg/kg) Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3 week cycle) Followed by: Trastuzumab - 6 mg/kg IV q 3 weekly until disease progression.
473066|NCT00667251|P1|Participant Flow|Lapatinib|Lapatinib - 1250 mg po daily Taxane based chemotherapy: Paclitaxel - 80 mg/m2 IV q weekly (days 1, 8 and 15 of a 4-week cycle) or Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3-week cycle) plus G-CSF - according to institutional standards. Followed by: Lapatinib - 1500 mg po daily until disease progression.
473067|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
473068|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
473069|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
473070|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
473071|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
473072|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
473073|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
473074|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
473075|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
473076|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
473077|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
473089|NCT00667277|B1|Baseline|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.
bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
473090|NCT00667277|P1|Participant Flow|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.
bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
473092|NCT00667277|O1|Outcome|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.
bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
473093|NCT00667277|E1|Reported Event|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.
bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
473094|NCT00667342|B4|Baseline|Total|Total of all reporting groups
473095|NCT00667342|B3|Baseline|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
473096|NCT00667342|B2|Baseline|B: Localized Unresectable Disease|Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
473097|NCT00667342|B1|Baseline|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
473098|NCT00667342|P3|Participant Flow|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
473099|NCT00667342|P2|Participant Flow|B: Localized Unresectable Disease|Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
473100|NCT00667342|P1|Participant Flow|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
473101|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
473102|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
473103|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
473104|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
473105|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
473106|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
473107|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
473108|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
473109|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
473110|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
473111|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
473112|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
473113|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
473114|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
473115|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
473116|NCT00667342|O1|Outcome|All Participants|Thirty-two participants with osteosarcoma were evaluated in this study. The analysis for this outcome measure included 23 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 8 Stratum C participants who had metastatic tumors.
473117|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants in this study had osteosarcoma. This analysis includes 29 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 11 Stratum C participants who had metastatic tumors.
473118|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants in this study had osteosarcoma. This analysis includes 29 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 11 Stratum C participants who had metastatic tumors.
473119|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants in this study had osteosarcoma. This analysis includes 29 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 11 Stratum C participants who had metastatic tumors.
473120|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
473121|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
473122|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
473123|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
473124|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
473125|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
473126|NCT00667342|O1|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
473244|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473127|NCT00667342|O1|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
473128|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants were included in this analysis
473129|NCT00667342|O1|Outcome|All Participants|All the 42 evaluable participants in this study had osteosarcoma, of which 22 had events and 20 had no event.
473130|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
473170|NCT00667381|B3|Baseline|Total|Total of all reporting groups
473131|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
473132|NCT00667342|O1|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
473133|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
473134|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
473135|NCT00667342|E2|Reported Event|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
473136|NCT00667342|E1|Reported Event|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
473137|NCT00667355|B1|Baseline|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473138|NCT00667355|P1|Participant Flow|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473139|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473140|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473141|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473142|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473143|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473144|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473145|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473146|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473147|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473148|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473149|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473150|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473151|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473152|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473153|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473154|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473155|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473156|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473157|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473158|NCT00667355|E1|Reported Event|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
473159|NCT00667368|B3|Baseline|Total|Total of all reporting groups
473160|NCT00667368|B2|Baseline|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
473161|NCT00667368|B1|Baseline|Control|Bi-monthly testing for BV without treatment.
473162|NCT00667368|P2|Participant Flow|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
473163|NCT00667368|P1|Participant Flow|Control|Bi-monthly testing for BV without treatment.
473164|NCT00667368|O2|Outcome|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
473166|NCT00667368|O2|Outcome|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
473167|NCT00667368|O1|Outcome|Control|Bi-monthly testing for BV without treatment.
473168|NCT00667368|E2|Reported Event|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
473169|NCT00667368|E1|Reported Event|Control|Bi-monthly testing for BV without treatment.
473171|NCT00667381|B2|Baseline|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
473172|NCT00667381|B1|Baseline|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
473173|NCT00667381|P2|Participant Flow|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
473174|NCT00667381|P1|Participant Flow|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
473175|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
473176|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
473177|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
473178|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
473179|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
473180|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
473181|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
473182|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
473183|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
473184|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
473185|NCT00667381|E2|Reported Event|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
473186|NCT00667381|E1|Reported Event|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
473187|NCT00667394|B3|Baseline|Total|Total of all reporting groups
473188|NCT00667394|B2|Baseline|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
473189|NCT00667394|B1|Baseline|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
473190|NCT00667394|P2|Participant Flow|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
473191|NCT00667394|P1|Participant Flow|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
473192|NCT00667394|O2|Outcome|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
473193|NCT00667394|O1|Outcome|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
473194|NCT00667394|O2|Outcome|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
473195|NCT00667394|O1|Outcome|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
473196|NCT00667394|E2|Reported Event|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
473197|NCT00667394|E1|Reported Event|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
473198|NCT00667420|B1|Baseline|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
473199|NCT00667420|P1|Participant Flow|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
473200|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
473201|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
473202|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
473203|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
473204|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
474704|NCT00671879|E3|Reported Event|Placebo|Placebo treatment arm
473205|NCT00667420|E1|Reported Event|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
473206|NCT00667446|B3|Baseline|Total|Total of all reporting groups
473207|NCT00667446|B2|Baseline|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
473208|NCT00667446|B1|Baseline|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
473209|NCT00667446|P2|Participant Flow|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
473210|NCT00667446|P1|Participant Flow|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
473211|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
473212|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
473213|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
473214|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
473215|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
473216|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
473217|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
473218|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
473219|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
473220|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
473221|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
473222|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
473223|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
473224|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
473225|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
473226|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
473227|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
473228|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
473229|NCT00667446|E2|Reported Event|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
473230|NCT00667446|E1|Reported Event|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
473231|NCT00667459|B3|Baseline|Total|Total of all reporting groups
473232|NCT00667459|B2|Baseline|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473233|NCT00667459|B1|Baseline|Investigational|PRESTIGE® LP Cervical Disc
473234|NCT00667459|P2|Participant Flow|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876)
473235|NCT00667459|P1|Participant Flow|Investigational|PRESTIGE® LP Cervical Disc
473236|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473237|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473238|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473239|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473240|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473241|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473242|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473243|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473246|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473247|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473248|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473249|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473250|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473251|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
474948|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
473252|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473253|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473254|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473255|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473256|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473257|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473258|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473259|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473260|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473261|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473262|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473263|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473264|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473265|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473266|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473267|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473268|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473269|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473270|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473271|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
473272|NCT00667459|E2|Reported Event|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
473273|NCT00667459|E1|Reported Event|Investigational|PRESTIGE® LP Cervical Disc
473274|NCT00667563|B1|Baseline|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
DNA analysis: Weeks 0, 2, 10, 26, and 52.
polymerase chain reaction: Screening, week 36, and week 52.
cytology specimen collection procedure: Screening, week 36, and week 52.
colposcopic biopsy: Screening, week 36, and week 52."
473275|NCT00667563|P1|Participant Flow|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
DNA analysis: Weeks 0, 2, 10, 26, and 52.
polymerase chain reaction: Screening, week 36, and week 52.
cytology specimen collection procedure: Screening, week 36, and week 52.
colposcopic biopsy: Screening, week 36, and week 52."
473276|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
DNA analysis: Weeks 0, 2, 10, 26, and 52.
polymerase chain reaction: Screening, week 36, and week 52.
cytology specimen collection procedure: Screening, week 36, and week 52.
colposcopic biopsy: Screening, week 36, and week 52."
473277|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
DNA analysis: Weeks 0, 2, 10, 26, and 52.
polymerase chain reaction: Screening, week 36, and week 52.
cytology specimen collection procedure: Screening, week 36, and week 52.
colposcopic biopsy: Screening, week 36, and week 52."
473278|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
DNA analysis: Weeks 0, 2, 10, 26, and 52.
polymerase chain reaction: Screening, week 36, and week 52.
cytology specimen collection procedure: Screening, week 36, and week 52.
colposcopic biopsy: Screening, week 36, and week 52."
473279|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
DNA analysis: Weeks 0, 2, 10, 26, and 52.
polymerase chain reaction: Screening, week 36, and week 52.
cytology specimen collection procedure: Screening, week 36, and week 52.
colposcopic biopsy: Screening, week 36, and week 52."
473318|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
473319|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
473280|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
DNA analysis: Weeks 0, 2, 10, 26, and 52.
polymerase chain reaction: Screening, week 36, and week 52.
cytology specimen collection procedure: Screening, week 36, and week 52.
colposcopic biopsy: Screening, week 36, and week 52."
473933|NCT00669331|E2|Reported Event|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473281|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
DNA analysis: Weeks 0, 2, 10, 26, and 52.
polymerase chain reaction: Screening, week 36, and week 52.
cytology specimen collection procedure: Screening, week 36, and week 52.
colposcopic biopsy: Screening, week 36, and week 52."
473282|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
DNA analysis: Weeks 0, 2, 10, 26, and 52.
polymerase chain reaction: Screening, week 36, and week 52.
cytology specimen collection procedure: Screening, week 36, and week 52.
colposcopic biopsy: Screening, week 36, and week 52."
473283|NCT00667563|E1|Reported Event|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
DNA analysis: Weeks 0, 2, 10, 26, and 52.
polymerase chain reaction: Screening, week 36, and week 52.
cytology specimen collection procedure: Screening, week 36, and week 52.
colposcopic biopsy: Screening, week 36, and week 52."
473284|NCT00667576|B6|Baseline|Total|Total of all reporting groups
473285|NCT00667576|B5|Baseline|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
473286|NCT00667576|B4|Baseline|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
473287|NCT00667576|B3|Baseline|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
473288|NCT00667576|B2|Baseline|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
473289|NCT00667576|B1|Baseline|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
473290|NCT00667576|P5|Participant Flow|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
473291|NCT00667576|P4|Participant Flow|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
473292|NCT00667576|P3|Participant Flow|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
473293|NCT00667576|P2|Participant Flow|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
473294|NCT00667576|P1|Participant Flow|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
473295|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
473296|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
473297|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
473298|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
473299|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
473300|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
473301|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
473302|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
473303|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
473304|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
473305|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
473306|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
473307|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
473308|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
473309|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
473310|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
473311|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
473312|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
473313|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
473314|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
473315|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
473316|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
473317|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
473320|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
473321|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
473322|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
473323|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
473324|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
473325|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
473326|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
473327|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
473328|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
473329|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
473330|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
473331|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
473332|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
473333|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
473334|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
473335|NCT00667576|E5|Reported Event|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
473336|NCT00667576|E4|Reported Event|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
473337|NCT00667576|E3|Reported Event|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
473338|NCT00667576|E2|Reported Event|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
473339|NCT00667576|E1|Reported Event|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
473340|NCT00667589|B5|Baseline|Total|Total of all reporting groups
473341|NCT00667589|B4|Baseline|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
473342|NCT00667589|B3|Baseline|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
473343|NCT00667589|B2|Baseline|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
473344|NCT00667589|B1|Baseline|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
473345|NCT00667589|P4|Participant Flow|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
473346|NCT00667589|P3|Participant Flow|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
473347|NCT00667589|P2|Participant Flow|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
473348|NCT00667589|P1|Participant Flow|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
473349|NCT00667589|O3|Outcome|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
473350|NCT00667589|O2|Outcome|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
473351|NCT00667589|O1|Outcome|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
473352|NCT00667589|O1|Outcome|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
473353|NCT00667589|E4|Reported Event|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
473354|NCT00667589|E3|Reported Event|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
473355|NCT00667589|E2|Reported Event|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
473356|NCT00667589|E1|Reported Event|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
473357|NCT00667602|B4|Baseline|Total|Total of all reporting groups
473358|NCT00667602|B3|Baseline|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473359|NCT00667602|B2|Baseline|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473360|NCT00667602|B1|Baseline|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473361|NCT00667602|P3|Participant Flow|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473362|NCT00667602|P2|Participant Flow|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473363|NCT00667602|P1|Participant Flow|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473364|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473365|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473366|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473367|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473560|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473368|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473369|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473370|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473371|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473372|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473373|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473374|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473375|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473376|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473377|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473378|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473379|NCT00667602|O3|Outcome|MenC(1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473380|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473381|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473382|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473383|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473384|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473385|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473386|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473387|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473388|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473389|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473390|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473391|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and concomitant dose of PCV7 and DTPa-IPV-HepBHib at 12 months.
473392|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473393|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473394|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473395|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473396|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473397|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473398|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473399|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473400|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473401|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473402|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473403|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473404|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473405|NCT00667602|E3|Reported Event|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473406|NCT00667602|E2|Reported Event|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473407|NCT00667602|E1|Reported Event|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
473408|NCT00667693|B3|Baseline|Total|Total of all reporting groups
473409|NCT00667693|B2|Baseline|Pentax|"intubation with a the Pentax AWS
Pentax AWS: Intubation with Pentax AWS"
473410|NCT00667693|B1|Baseline|Macintosh|"Intubation with a Macintosh laryngoscope
Macintosh intubation: Macintosh intubation"
473411|NCT00667693|P2|Participant Flow|Pentax|"intubation with a the Pentax AWS
Pentax AWS: Intubation with Pentax AWS"
473412|NCT00667693|P1|Participant Flow|Macintosh|"Intubation with a Macintosh laryngoscope
Macintosh intubation: Macintosh intubation"
473413|NCT00667693|O2|Outcome|Pentax|"intubation with a the Pentax AWS
Pentax AWS: Intubation with Pentax AWS"
473414|NCT00667693|O1|Outcome|Macintosh|"Intubation with a Macintosh laryngoscope
Macintosh intubation: Macintosh intubation"
473415|NCT00667693|E2|Reported Event|Pentax|"intubation with a the Pentax AWS
Pentax AWS: Intubation with Pentax AWS"
473416|NCT00667693|E1|Reported Event|Macintosh|"Intubation with a Macintosh laryngoscope
Macintosh intubation: Macintosh intubation"
473417|NCT00667732|B3|Baseline|Total|Total of all reporting groups
473418|NCT00667732|B2|Baseline|Placebo Group|"Participants will receive placebo rather than exenatide as part of their diabetes treatment
placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks"
473419|NCT00667732|B1|Baseline|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment
exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
473420|NCT00667732|P3|Participant Flow|Placebo Group|"After run-in participants were randomized to placebo.
placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks
metformin: continued at same dose participant entered study on.
Lantus Insulin: titrated per protocol depending on blood sugar levels
In extension period, participants continued regular regimen with open label exenatide instead of placebo"
473421|NCT00667732|P2|Participant Flow|Exenatide Group|"After run-in participants were randomized to exenatide.
exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
metformin: continued at same dose participant entered study on.
Lantus Insulin: titrated per protocol depending on blood sugar levels
In extension period, participants continued regular regimen with open label exenatide"
473422|NCT00667732|P1|Participant Flow|Run-In Group|"All participants took exenatide twice daily in addition to their Metformin dose.
A subset of participants agreed to a substudy (20 pts) and had a glucose and metabolic profile done at this time."
473423|NCT00667732|O2|Outcome|Placebo Group|
473424|NCT00667732|O1|Outcome|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment
exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
473425|NCT00667732|O2|Outcome|Placebo Group|"Participants will receive placebo rather than exenatide as part of their diabetes treatment
placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks"
473426|NCT00667732|O1|Outcome|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment
exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
473427|NCT00667732|E5|Reported Event|Exenatide Open-Label (Previous Placebo)|Participants who were in the Placebo Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
473428|NCT00667732|E4|Reported Event|Exenatide Open-Label (Previous Exenatide)|Participants who were in the Exenatide Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
473429|NCT00667732|E3|Reported Event|Placebo Randomization Period|After run-in participants were randomized to placebo. placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
473430|NCT00667732|E2|Reported Event|Exenatide Randomization Group|After run-in participants were randomized to exenatide. exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
473431|NCT00667732|E1|Reported Event|Run-In Group|All participants took exenatide twice daily in addition to their Metformin dose.
473432|NCT00667745|B3|Baseline|Total|Total of all reporting groups
473433|NCT00667745|B2|Baseline|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.
Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
473434|NCT00667745|B1|Baseline|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.
Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.
Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
473561|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
473435|NCT00667745|P2|Participant Flow|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.
Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
473934|NCT00669331|E1|Reported Event|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473436|NCT00667745|P1|Participant Flow|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.
Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.
Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
473437|NCT00667745|O2|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.
Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
473438|NCT00667745|O1|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.
Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.
Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
473439|NCT00667745|O2|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.
Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
473440|NCT00667745|O1|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.
Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.
Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
473441|NCT00667745|E2|Reported Event|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.
Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
473442|NCT00667745|E1|Reported Event|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.
Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.
Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
473443|NCT00667810|B5|Baseline|Total|Total of all reporting groups
473444|NCT00667810|B4|Baseline|Bapineuzumab 2.0 mg/kg|Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473445|NCT00667810|B3|Baseline|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473446|NCT00667810|B2|Baseline|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473447|NCT00667810|B1|Baseline|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473448|NCT00667810|P4|Participant Flow|Bapineuzumab 2.0 mg/kg|Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473449|NCT00667810|P3|Participant Flow|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473450|NCT00667810|P2|Participant Flow|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473451|NCT00667810|P1|Participant Flow|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by intravenous (IV) infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473452|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473453|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473454|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473455|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473456|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473457|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473458|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473459|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473460|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473461|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473462|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473463|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473464|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473465|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473466|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473467|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473468|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473469|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473470|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473471|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473472|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473473|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473474|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473475|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473476|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473477|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473478|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473479|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473480|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473513|NCT00667849|O1|Outcome|Exogen 4000+|"Single arm, Exogen 4000+
Low-intensity pulsed ultrasound (LIPUS)"
473935|NCT00669396|B3|Baseline|Total|Total of all reporting groups
473481|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473482|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg - Placebo|For the DAD total score, results are presented from a REML)-based MMRM.
473483|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg - Placebo|For the DAD total score, results are presented from a REML-based MMRM.
473484|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg - Placebo|For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
473485|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg - Placebo|For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
473486|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473487|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473488|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473489|NCT00667810|O4|Outcome|Pooled Bapineuzumab 0.5/1.0 mg/kg|Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined
473490|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473491|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473492|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473493|NCT00667810|O4|Outcome|Pooled Bapineuzumab 0.5/1.0 mg/kg|Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined to form the Pooled Bapineuzumab group.
473494|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473495|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473496|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473497|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473498|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473499|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473500|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473501|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473502|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473503|NCT00667810|E4|Reported Event|Bapineuzumab 2.0 mg/kg|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473504|NCT00667810|E3|Reported Event|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473505|NCT00667810|E2|Reported Event|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473506|NCT00667810|E1|Reported Event|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
473507|NCT00667849|B3|Baseline|Total|Total of all reporting groups
473508|NCT00667849|B2|Baseline|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound).
Sham: sham device identical to active device with the exception of administration of ultrasound"
473509|NCT00667849|B1|Baseline|Exogen 4000+|"Single arm, Exogen 4000+
Low-intensity pulsed ultrasound (LIPUS)"
473510|NCT00667849|P2|Participant Flow|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)
Sham: sham device identical to active device with the exception of administration of ultrasound"
473511|NCT00667849|P1|Participant Flow|Exogen 4000+|"Single arm, Exogen 4000+
Low-intensity pulsed ultrasound (LIPUS)"
473512|NCT00667849|O2|Outcome|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)
sham: sham device identical to active device with the exception of administration of ultrasound"
473514|NCT00667849|O2|Outcome|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)
Sham: device identical to active device with the exception of administration of ultrasound"
473515|NCT00667849|O1|Outcome|Exogen 4000+|Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
473516|NCT00667849|O2|Outcome|Sham|Single arm, sham (identical to active device with the exception of administration of ultrasound)
473517|NCT00667849|O1|Outcome|Exogen 4000+|Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
473518|NCT00667849|E2|Reported Event|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)
Sham: device identical to active device with the exception of administration of ultrasound"
473519|NCT00667849|E1|Reported Event|Exogen 4000+|"Single arm, active Exogen 4000+ ultrasound bone healing system
Low-intensity pulsed ultrasound (LIPUS)"
473520|NCT00667875|B4|Baseline|Total|Total of all reporting groups
473521|NCT00667875|B3|Baseline|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole
Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
473522|NCT00667875|B2|Baseline|2 Naltrexone|"Naltrexone
Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
473523|NCT00667875|B1|Baseline|1 Placebo|Placebo : placebo
473524|NCT00667875|P3|Participant Flow|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole
Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
473525|NCT00667875|P2|Participant Flow|2 Naltrexone|"Naltrexone
Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
473526|NCT00667875|P1|Participant Flow|1 Placebo|Placebo : placebo
473527|NCT00667875|O3|Outcome|Naltrexone + Aripiprazole|Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
473528|NCT00667875|O2|Outcome|Naltrexone and Inactive Placebo Aripiprazole|Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
473529|NCT00667875|O1|Outcome|Inactive Placebo|Inactive placebo naltrexone + inactive placebo Aripiprazole
473530|NCT00667875|E3|Reported Event|Naltrexone + Aripiprazole|Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
473531|NCT00667875|E2|Reported Event|Naltrexone and Inactive Placebo Aripiprazole|Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
473532|NCT00667875|E1|Reported Event|Inactive Placebo|Inactive placebo naltrexone + inactive placebo Aripiprazole
473533|NCT00667992|B3|Baseline|Total|Total of all reporting groups
473534|NCT00667992|B2|Baseline|Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA|Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.
473535|NCT00667992|B1|Baseline|Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC|Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily, First then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.
473536|NCT00667992|P2|Participant Flow|Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA|Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, Wash out, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.
473537|NCT00667992|P1|Participant Flow|Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC|Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily First, Wash out, then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.
473538|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473539|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
473540|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473541|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
473542|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473543|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
473544|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473545|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
473546|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473547|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
473548|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473549|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
473550|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473551|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
473552|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473553|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
473554|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473555|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
473556|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473557|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
473558|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473559|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
476207|NCT00676585|P2|Participant Flow|Intervention|Hydrocortisone
473562|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473563|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
473564|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473565|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
473566|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473567|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
473568|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473569|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
473570|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473571|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
473572|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473573|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
473574|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473575|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
473576|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473577|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
473578|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473579|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
473580|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473581|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
473582|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473583|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
473584|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473585|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
473586|NCT00667992|E4|Reported Event|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
473587|NCT00667992|E3|Reported Event|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
473588|NCT00667992|E2|Reported Event|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
473589|NCT00667992|E1|Reported Event|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
473590|NCT00668200|B1|Baseline|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
473591|NCT00668200|P1|Participant Flow|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
473592|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
473593|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
473594|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
473595|NCT00668200|E1|Reported Event|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
473596|NCT00668265|B3|Baseline|Total|Total of all reporting groups
473597|NCT00668265|B2|Baseline|Placebo|Subjects on methadone maintenance receiving placebo while inpatients in a methadone treatment facility Su Casa
473598|NCT00668265|B1|Baseline|Quetiapine|Subjects on MMTP receiving quetiapine
473599|NCT00668265|P2|Participant Flow|Placebo Arm|The subjects in the placebo arm received inactive pills in identical blister packs
473600|NCT00668265|P1|Participant Flow|Quetiapine Arm|"The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.
Concomitant Medications:
Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed"
473601|NCT00668265|O2|Outcome|Placebo Arm|The subjects in the placebo arm received inactive pills in identical blister packs
473602|NCT00668265|O1|Outcome|Quetiapine Arm|"The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.
Concomitant Medications:
Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed"
473603|NCT00668265|O2|Outcome|Placebo|
473604|NCT00668265|O1|Outcome|Quetiapine|
476208|NCT00676585|P1|Participant Flow|Control|Normal Saline
473605|NCT00668265|E2|Reported Event|Placebo|Placebo arm for subjects on MMTP in Su Casa Residence
473606|NCT00668265|E1|Reported Event|Quetiapine|Active treatment arm for subjects on MMTP in Su Casa residence
473607|NCT00668317|B1|Baseline|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
473608|NCT00668317|P1|Participant Flow|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
473609|NCT00668317|O1|Outcome|Omeprazole and Ranitidine|Therapy with omeprazole 20 mg twice a day (BD) and Ranitidine 300mg once a day (od) at night (nocte)
473610|NCT00668317|E1|Reported Event|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
473611|NCT00668382|B1|Baseline|Alpha-Gal Glycosphingolipid Injection|Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
473612|NCT00668382|P1|Participant Flow|Alpha-Gal Glycosphingolipid Injection|Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
473613|NCT00668382|O1|Outcome|Intratumoral Injection|Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
473614|NCT00668382|E1|Reported Event|Intratumoral Injection|Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
473615|NCT00668395|B4|Baseline|Total|Total of all reporting groups
473616|NCT00668395|B3|Baseline|CYP2B6*6/*6|Slow metabolizer
473617|NCT00668395|B2|Baseline|CYP2B6*1/*6|Intermediate metabolizer
473618|NCT00668395|B1|Baseline|CYP2B6*1/*1|Normal metabolizer
473619|NCT00668395|P3|Participant Flow|CYP2B6*6/*6 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).
During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.
The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
473620|NCT00668395|P2|Participant Flow|CYP2B6*1/*6 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).
During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.
The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
473621|NCT00668395|P1|Participant Flow|CYP2B6*1/*1 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).
During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.
The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
473622|NCT00668395|O3|Outcome|CYP2B6*6/*6|Slow metabolizer
473623|NCT00668395|O2|Outcome|CYP2B6*1/*6|Intermediate metabolizer
473624|NCT00668395|O1|Outcome|CYP2B6*1/*1|Normal metabolizer
473625|NCT00668395|E3|Reported Event|CYP2B6*6/*6|Slow metabolizer
473626|NCT00668395|E2|Reported Event|CYP2B6*1/*6|Intermediate metabolizer
473627|NCT00668395|E1|Reported Event|CYP2B6*1/*1|Normal metabolizer
473628|NCT00668434|B3|Baseline|Total|Total of all reporting groups
473629|NCT00668434|B2|Baseline|Placebo|"Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
473630|NCT00668434|B1|Baseline|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
473631|NCT00668434|P2|Participant Flow|Placebo|"Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
473632|NCT00668434|P1|Participant Flow|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
473633|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
473634|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
473635|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
473727|NCT00668902|E3|Reported Event|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473728|NCT00668902|E2|Reported Event|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473636|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
473637|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
473638|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
473639|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
473640|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
473641|NCT00668434|E2|Reported Event|Placebo|"Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
473642|NCT00668434|E1|Reported Event|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
473643|NCT00668525|B4|Baseline|Total|Total of all reporting groups
473644|NCT00668525|B3|Baseline|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473645|NCT00668525|B2|Baseline|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473646|NCT00668525|B1|Baseline|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473647|NCT00668525|P3|Participant Flow|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473648|NCT00668525|P2|Participant Flow|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473649|NCT00668525|P1|Participant Flow|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473650|NCT00668525|O3|Outcome|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473651|NCT00668525|O2|Outcome|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473652|NCT00668525|O1|Outcome|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473653|NCT00668525|O3|Outcome|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473654|NCT00668525|O2|Outcome|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473655|NCT00668525|O1|Outcome|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473656|NCT00668525|E3|Reported Event|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473657|NCT00668525|E2|Reported Event|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473658|NCT00668525|E1|Reported Event|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
473659|NCT00668564|B1|Baseline|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
473660|NCT00668564|P1|Participant Flow|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
473661|NCT00668564|O1|Outcome|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
473759|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473662|NCT00668564|O1|Outcome|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
473663|NCT00668564|E1|Reported Event|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
473664|NCT00668733|B3|Baseline|Total|Total of all reporting groups
473665|NCT00668733|B2|Baseline|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
473666|NCT00668733|B1|Baseline|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
473667|NCT00668733|P2|Participant Flow|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
473668|NCT00668733|P1|Participant Flow|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
473669|NCT00668733|O2|Outcome|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
473670|NCT00668733|O1|Outcome|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
473671|NCT00668733|E2|Reported Event|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
473672|NCT00668733|E1|Reported Event|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
473673|NCT00668746|B3|Baseline|Total|Total of all reporting groups
473674|NCT00668746|B2|Baseline|No Drug Intervention|A control consisting of no drug intervention
473675|NCT00668746|B1|Baseline|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
473676|NCT00668746|P2|Participant Flow|No Drug Intervention|A control consisting of no drug intervention
473677|NCT00668746|P1|Participant Flow|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
473678|NCT00668746|O6|Outcome|Control Group at Day 180|
473679|NCT00668746|O5|Outcome|Control Group at Day 30|
473680|NCT00668746|O4|Outcome|Control Group at Baseline|
473681|NCT00668746|O3|Outcome|Minocycline Group at Day 180|
473682|NCT00668746|O2|Outcome|Minocycline Group at Day 30|
473683|NCT00668746|O1|Outcome|Minocycline Group at Baseline|
473684|NCT00668746|O6|Outcome|Control Group at 180 Days|
473685|NCT00668746|O5|Outcome|Control Group at 30 Days|
473686|NCT00668746|O4|Outcome|Control Group at Baseline|
473687|NCT00668746|O3|Outcome|Micocycline Group at 180 Days|
473688|NCT00668746|O2|Outcome|Minocycline Group at 30 Days|
473689|NCT00668746|O1|Outcome|Minocycline Group at Baseline|
473690|NCT00668746|O2|Outcome|No Drug Intervention|A control consisting of no drug intervention
473691|NCT00668746|O1|Outcome|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
473692|NCT00668746|E2|Reported Event|No Drug Intervention|A control consisting of no drug intervention
473693|NCT00668746|E1|Reported Event|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
473694|NCT00668785|B1|Baseline|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
473695|NCT00668785|P1|Participant Flow|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
473696|NCT00668785|O1|Outcome|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
473697|NCT00668785|E1|Reported Event|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
473760|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473698|NCT00668863|B1|Baseline|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473699|NCT00668863|P1|Participant Flow|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473700|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473701|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473702|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473703|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473704|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473705|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473706|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473707|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473708|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473709|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473761|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473710|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473711|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473712|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473713|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473714|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473715|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473716|NCT00668863|E1|Reported Event|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
473717|NCT00668902|B4|Baseline|Total|Total of all reporting groups
473718|NCT00668902|B3|Baseline|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473719|NCT00668902|B2|Baseline|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473720|NCT00668902|B1|Baseline|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473721|NCT00668902|P3|Participant Flow|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473722|NCT00668902|P2|Participant Flow|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473723|NCT00668902|P1|Participant Flow|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473724|NCT00668902|O3|Outcome|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473725|NCT00668902|O2|Outcome|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473726|NCT00668902|O1|Outcome|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473729|NCT00668902|E1|Reported Event|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.
[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
473730|NCT00669019|B1|Baseline|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
473731|NCT00669019|P1|Participant Flow|Saracatinib|Patients receive saracatinib 175 mg oral, once daily in the absence of disease progression or unacceptable toxicity.
473732|NCT00669019|O1|Outcome|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
473733|NCT00669019|O1|Outcome|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
473734|NCT00669019|E1|Reported Event|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
473735|NCT00669032|B3|Baseline|Total|Total of all reporting groups
473736|NCT00669032|B2|Baseline|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473737|NCT00669032|B1|Baseline|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473738|NCT00669032|P2|Participant Flow|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473739|NCT00669032|P1|Participant Flow|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473740|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473741|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473742|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473743|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473744|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473745|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473746|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473747|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473748|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473749|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473750|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473751|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473752|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473753|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473754|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473755|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473756|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473757|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473758|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473923|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473762|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473928|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473763|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473764|NCT00669032|E2|Reported Event|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473765|NCT00669032|E1|Reported Event|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
473766|NCT00669071|B1|Baseline|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
473767|NCT00669071|P1|Participant Flow|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
473768|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
473769|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
473770|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
473771|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
473772|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
473773|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
473774|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
473775|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
473776|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
473777|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
473778|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
473779|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
473780|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
473781|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
473782|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
473783|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
473784|NCT00669071|E1|Reported Event|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
473785|NCT00669110|B3|Baseline|Total|Total of all reporting groups
473786|NCT00669110|B2|Baseline|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473787|NCT00669110|B1|Baseline|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473788|NCT00669110|P2|Participant Flow|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473789|NCT00669110|P1|Participant Flow|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473790|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473924|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473929|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473930|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473791|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473792|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473793|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473794|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473795|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473796|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473797|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473798|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473799|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473800|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473801|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473802|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473803|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473804|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473805|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473806|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473807|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473808|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473809|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
476209|NCT00676585|O2|Outcome|Intervention|Hydrocortisone
473810|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473811|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473812|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473813|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473814|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473815|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473816|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473817|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473818|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473819|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473820|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473821|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473822|NCT00669110|E2|Reported Event|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
473823|NCT00669110|E1|Reported Event|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
473824|NCT00669214|B3|Baseline|Total|Total of all reporting groups
473825|NCT00669214|B2|Baseline|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473826|NCT00669214|B1|Baseline|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473827|NCT00669214|P2|Participant Flow|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473828|NCT00669214|P1|Participant Flow|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473829|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473925|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473830|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473831|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473832|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473833|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473834|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473835|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473836|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473837|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473838|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473839|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473840|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473841|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473842|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473843|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473844|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473845|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473846|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473847|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473848|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473849|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473850|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473926|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473851|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473852|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473853|NCT00669214|E6|Reported Event|Efalizumab: Follow-Up Period|
473854|NCT00669214|E5|Reported Event|Placebo: Follow-Up Period|
473855|NCT00669214|E4|Reported Event|Efalizumab: Open-Label Period|
473856|NCT00669214|E3|Reported Event|Placebo: Open-Label Period|
473857|NCT00669214|E2|Reported Event|Efalizumab: Double-Blind Period|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473858|NCT00669214|E1|Reported Event|Placebo: Double-Blind Period|All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
473859|NCT00669240|B1|Baseline|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473860|NCT00669240|P1|Participant Flow|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473861|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473862|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473863|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473864|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473865|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473866|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473867|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473868|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473869|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473870|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473871|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473872|NCT00669240|E1|Reported Event|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
473873|NCT00669279|B3|Baseline|Total|Total of all reporting groups
473874|NCT00669279|B2|Baseline|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
473875|NCT00669279|B1|Baseline|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
473876|NCT00669279|P2|Participant Flow|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
473877|NCT00669279|P1|Participant Flow|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
473878|NCT00669279|O2|Outcome|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
473879|NCT00669279|O1|Outcome|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
473880|NCT00669279|E2|Reported Event|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
473881|NCT00669279|E1|Reported Event|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
473882|NCT00669318|B1|Baseline|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:
2 mg/m^2 pentostatin IV on days 8 and 22;
3 mg alemtuzumab subcutaneously (SC) on day 3;
10 mg alemtuzumab SC on day 4;
30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.
Courses 2 and 3: Patients receive:
2 mg/m^2 pentostatin IV on days 1 and 15;
30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
473883|NCT00669318|P1|Participant Flow|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:
2 mg/m^2 pentostatin IV on days 8 and 22;
3 mg alemtuzumab subcutaneously (SC) on day 3;
10 mg alemtuzumab SC on day 4;
30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.
Courses 2 and 3: Patients receive:
2 mg/m^2 pentostatin IV on days 1 and 15;
30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
473884|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:
2 mg/m^2 pentostatin IV on days 8 and 22;
3 mg alemtuzumab subcutaneously (SC) on day 3;
10 mg alemtuzumab SC on day 4;
30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.
Courses 2 and 3: Patients receive:
2 mg/m^2 pentostatin IV on days 1 and 15;
30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
473927|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
476210|NCT00676585|O1|Outcome|Control|Normal Saline
473885|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:
2 mg/m^2 pentostatin IV on days 8 and 22;
3 mg alemtuzumab subcutaneously (SC) on day 3;
10 mg alemtuzumab SC on day 4;
30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.
Courses 2 and 3: Patients receive:
2 mg/m^2 pentostatin IV on days 1 and 15;
30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
473886|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:
2 mg/m^2 pentostatin IV on days 8 and 22;
3 mg alemtuzumab subcutaneously (SC) on day 3;
10 mg alemtuzumab SC on day 4;
30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.
Courses 2 and 3: Patients receive:
2 mg/m^2 pentostatin IV on days 1 and 15;
30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
473887|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:
2 mg/m^2 pentostatin IV on days 8 and 22;
3 mg alemtuzumab subcutaneously (SC) on day 3;
10 mg alemtuzumab SC on day 4;
30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.
Courses 2 and 3: Patients receive:
2 mg/m^2 pentostatin IV on days 1 and 15;
30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
473888|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:
2 mg/m^2 pentostatin IV on days 8 and 22;
3 mg alemtuzumab subcutaneously (SC) on day 3;
10 mg alemtuzumab SC on day 4;
30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.
Courses 2 and 3: Patients receive:
2 mg/m^2 pentostatin IV on days 1 and 15;
30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
473889|NCT00669318|E1|Reported Event|Treatment (Pentostatin, Alemtuzumab, Rituximab)|sargramostim
473890|NCT00669331|B3|Baseline|Total|Total of all reporting groups
473891|NCT00669331|B2|Baseline|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473892|NCT00669331|B1|Baseline|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473893|NCT00669331|P2|Participant Flow|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473894|NCT00669331|P1|Participant Flow|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473895|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473896|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473897|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473898|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473899|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473900|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473901|NCT00669331|O2|Outcome|Control|"Matched control - inhaled mannitol 50mg
Matched control: 50mg dose of Mannitol BD for 52 weeks"
473902|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol 400mg
Inhaled mannitol: 400mg dose of Mannitol BD for 52 weeks"
473903|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473904|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473905|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473906|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473907|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473908|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473909|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473910|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473911|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473912|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473913|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473914|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473915|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473916|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473917|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473918|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473919|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473920|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473921|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
473922|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol
Inhaled mannitol: 400mg BD for 52 weeks"
473950|NCT00669461|B1|Baseline|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
473951|NCT00669461|P1|Participant Flow|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
473952|NCT00669461|O1|Outcome|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
473953|NCT00669461|O1|Outcome|Lubiprostone|Lubiprostone 24 micrograms po BID given for total of 4 weeks
473954|NCT00669461|E1|Reported Event|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
473955|NCT00669539|B3|Baseline|Total|Total of all reporting groups
473956|NCT00669539|B2|Baseline|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
473957|NCT00669539|B1|Baseline|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
473958|NCT00669539|P2|Participant Flow|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
473959|NCT00669539|P1|Participant Flow|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
473960|NCT00669539|O2|Outcome|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
473961|NCT00669539|O1|Outcome|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
473962|NCT00669539|E2|Reported Event|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
473963|NCT00669539|E1|Reported Event|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
473964|NCT00669552|B1|Baseline|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
473965|NCT00669552|P1|Participant Flow|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
473966|NCT00669552|O1|Outcome|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
473967|NCT00669552|E1|Reported Event|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
473968|NCT00669578|B3|Baseline|Total|Total of all reporting groups
473969|NCT00669578|B2|Baseline|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
473970|NCT00669578|B1|Baseline|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
473971|NCT00669578|P2|Participant Flow|Phase II|All patients enrolled to this phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
476211|NCT00676585|O2|Outcome|Intervention|Hydrocortisone
473972|NCT00669578|P1|Participant Flow|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
473973|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
473974|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
473975|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
473976|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
474016|NCT00669903|B3|Baseline|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
474017|NCT00669903|B2|Baseline|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
473977|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
473978|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
473979|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
473980|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
473981|NCT00669578|O2|Outcome|Phase II|All patients enrolled to this phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
473982|NCT00669578|O1|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
473983|NCT00669578|E1|Reported Event|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
473984|NCT00669617|B1|Baseline|Total Population|Participants were randomized to one of five treatment sequences. Each treatment sequence comprised 5 double-blind, single dose treatment periods (Periods I to V), separated by a washout period of 4-7 days. Participants received each of the 5 blinded-treatments: indacaterol 150 μg, indacaterol 300 μg, salmeterol/fluticasone 50/500 μg, salbutamol 200 μg and placebo.
473985|NCT00669617|P5|Participant Flow|Placebo, Salbut, Salm/Flut , Ind 300μg, Ind 150μg|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/Flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473986|NCT00669617|P4|Participant Flow|Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/Flut|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473987|NCT00669617|P3|Participant Flow|Salm/Flut, Placebo, Ind 150μg, Salbut, Ind 300μg|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473988|NCT00669617|P2|Participant Flow|Ind 300μg, Ind 150μg, Salbut, Salm/Flut, Placebo|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
474065|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
473989|NCT00669617|P1|Participant Flow|Ind 150μg, Salm/Flut, Ind 300μg, Placebo, Salbut|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473990|NCT00669617|O5|Outcome|Salbutamol|Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473991|NCT00669617|O4|Outcome|Salmeterol/Fluticasone|Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
474018|NCT00669903|B1|Baseline|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
474019|NCT00669903|P4|Participant Flow|Placebo|Placebo
473992|NCT00669617|O3|Outcome|Placebo|Participants received placebo to indacaterol delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous one by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473993|NCT00669617|O2|Outcome|Indacaterol 300 µg|Participants received a single dose of Indacaterol 300 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and a placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473994|NCT00669617|O1|Outcome|Indacaterol 150 µg|Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473995|NCT00669617|E5|Reported Event|Placebo|Participants received placebo to indacaterol delivered via SDDPI, a placebo to salmeterol/fluticasone delivered via MDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473996|NCT00669617|E4|Reported Event|Salmeterol/Fluticasone|Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473997|NCT00669617|E3|Reported Event|Salbutamol|Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473998|NCT00669617|E2|Reported Event|Indacaterol 300 µg|Participants received a single dose of Indacaterol 300 µg delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
473999|NCT00669617|E1|Reported Event|Indacaterol 150 µg|Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
474000|NCT00669682|B1|Baseline|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
474001|NCT00669682|P1|Participant Flow|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
474002|NCT00669682|O2|Outcome|Negative Optivol Status|These patients have transthoracic impedance measurements that do not suggest fluid overload
474003|NCT00669682|O1|Outcome|Positive Optivol Status|These patients have transthoracic impedance measurements that suggest fluid overload
474004|NCT00669682|E1|Reported Event|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
474005|NCT00669864|B1|Baseline|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
474006|NCT00669864|P1|Participant Flow|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
474066|NCT00669916|E2|Reported Event|Placebo|Placebo was administered intravenously as a single dose.
474007|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
474008|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
474009|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
474010|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
474011|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
474012|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
474013|NCT00669864|E1|Reported Event|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
474014|NCT00669903|B5|Baseline|Total|Total of all reporting groups
474020|NCT00669903|P3|Participant Flow|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
474021|NCT00669903|P2|Participant Flow|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
474022|NCT00669903|P1|Participant Flow|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
474023|NCT00669903|O4|Outcome|Placebo|Placebo
474024|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
474025|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
474026|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
474027|NCT00669903|O4|Outcome|Placebo|Placebo
474028|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
474029|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
474030|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
474031|NCT00669903|O4|Outcome|Placebo|Placebo
474032|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
474033|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
474034|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
474035|NCT00669903|O4|Outcome|Placebo|Placebo
474036|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
474037|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
474038|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
474039|NCT00669903|O4|Outcome|Placebo|Placebo
474040|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
474041|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
474042|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
474043|NCT00669903|O4|Outcome|Placebo|Placebo
474044|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
474045|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
474046|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
474047|NCT00669903|E4|Reported Event|Placebo|Placebo
474048|NCT00669903|E3|Reported Event|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
474049|NCT00669903|E2|Reported Event|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
474050|NCT00669903|E1|Reported Event|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
474051|NCT00669916|B3|Baseline|Total|Total of all reporting groups
474052|NCT00669916|B2|Baseline|Placebo|Placebo was administered intravenously as a single dose.
474053|NCT00669916|B1|Baseline|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
474054|NCT00669916|P2|Participant Flow|Placebo|Placebo was administered intravenously as a single dose.
474055|NCT00669916|P1|Participant Flow|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
474056|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
474057|NCT00669916|O2|Outcome|Placebo|Placebo was administered intravenously as a single dose.
474058|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
474059|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
474060|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
474061|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
474062|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
474063|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
474064|NCT00669916|O2|Outcome|Placebo|Placebo was administered intravenously as a single dose.
474067|NCT00669916|E1|Reported Event|AIN457A|AIN457A 3mg/kg was administered intravenously as a single dose.
474068|NCT00669942|B13|Baseline|Total|Total of all reporting groups
474069|NCT00669942|B12|Baseline|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
474070|NCT00669942|B11|Baseline|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
474071|NCT00669942|B10|Baseline|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474072|NCT00669942|B9|Baseline|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474073|NCT00669942|B8|Baseline|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474074|NCT00669942|B7|Baseline|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474075|NCT00669942|B6|Baseline|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474076|NCT00669942|B5|Baseline|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
474077|NCT00669942|B4|Baseline|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
474078|NCT00669942|B3|Baseline|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474079|NCT00669942|B2|Baseline|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
474080|NCT00669942|B1|Baseline|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
474081|NCT00669942|P12|Participant Flow|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
474082|NCT00669942|P11|Participant Flow|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
474083|NCT00669942|P10|Participant Flow|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474084|NCT00669942|P9|Participant Flow|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474085|NCT00669942|P8|Participant Flow|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474086|NCT00669942|P7|Participant Flow|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474087|NCT00669942|P6|Participant Flow|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474088|NCT00669942|P5|Participant Flow|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
474089|NCT00669942|P4|Participant Flow|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
474090|NCT00669942|P3|Participant Flow|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474091|NCT00669942|P2|Participant Flow|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
474092|NCT00669942|P1|Participant Flow|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
474093|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474094|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474095|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474096|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474097|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474098|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474099|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474100|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474101|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474102|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474103|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474104|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474105|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474106|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474152|NCT00669942|E1|Reported Event|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
474107|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474108|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474109|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474110|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474111|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474112|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474113|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474114|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474115|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
474116|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474465|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
474117|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
474118|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
474119|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
474120|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474121|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
474122|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
474123|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
474124|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474125|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
474126|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
474127|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
474128|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474129|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
474130|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
474131|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
474132|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474133|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
474134|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
474135|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
474136|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474137|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
474138|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
474139|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474140|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474141|NCT00669942|E12|Reported Event|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
474142|NCT00669942|E11|Reported Event|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
474143|NCT00669942|E10|Reported Event|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474144|NCT00669942|E9|Reported Event|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474145|NCT00669942|E8|Reported Event|Parts 2 and 3 - AIN457 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474146|NCT00669942|E7|Reported Event|Parts 2 and 3 - AIN457 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474147|NCT00669942|E6|Reported Event|Parts 2 and 3 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
474148|NCT00669942|E5|Reported Event|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
474149|NCT00669942|E4|Reported Event|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
474150|NCT00669942|E3|Reported Event|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
474151|NCT00669942|E2|Reported Event|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
474154|NCT00669955|B2|Baseline|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
474155|NCT00669955|B1|Baseline|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
474156|NCT00669955|P2|Participant Flow|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
474157|NCT00669955|P1|Participant Flow|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
474158|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
474159|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
474160|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
474161|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
474162|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
474163|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
474164|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
474165|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
474166|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
474167|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
474168|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
474169|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
474170|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
474171|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
474172|NCT00669955|E2|Reported Event|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
474173|NCT00669955|E1|Reported Event|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
474174|NCT00663702|B3|Baseline|Total|Total of all reporting groups
474175|NCT00663702|B2|Baseline|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474176|NCT00663702|B1|Baseline|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or BMS IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474177|NCT00663702|P2|Participant Flow|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474178|NCT00663702|P1|Participant Flow|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474179|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474260|NCT00664066|O1|Outcome|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
474180|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474181|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474182|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474183|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474949|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
474184|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474185|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474186|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474187|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474188|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474189|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474190|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474191|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474192|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474193|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474194|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474195|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474196|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474197|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474198|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474199|NCT00663702|E1|Reported Event|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
474200|NCT00663793|B3|Baseline|Total|Total of all reporting groups
474201|NCT00663793|B2|Baseline|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474202|NCT00663793|B1|Baseline|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474203|NCT00663793|P2|Participant Flow|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474204|NCT00663793|P1|Participant Flow|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474205|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474206|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474207|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474208|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474261|NCT00664066|E1|Reported Event|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
474209|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474210|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474211|NCT00663793|E2|Reported Event|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474339|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474212|NCT00663793|E1|Reported Event|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
474213|NCT00663819|B3|Baseline|Total|Total of all reporting groups
474214|NCT00663819|B2|Baseline|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
474215|NCT00663819|B1|Baseline|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
474216|NCT00663819|P2|Participant Flow|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
474217|NCT00663819|P1|Participant Flow|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
474218|NCT00663819|O2|Outcome|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
474219|NCT00663819|O1|Outcome|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
474220|NCT00663819|E2|Reported Event|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
474221|NCT00663819|E1|Reported Event|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
474222|NCT00663858|B4|Baseline|Total|Total of all reporting groups
474223|NCT00663858|B3|Baseline|Placebo|Placebo on Week 0, 2, 26 and 28.
474224|NCT00663858|B2|Baseline|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
474225|NCT00663858|B1|Baseline|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
474226|NCT00663858|P3|Participant Flow|Placebo|Placebo on Week 0, 2, 26 and 28.
474227|NCT00663858|P2|Participant Flow|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
474228|NCT00663858|P1|Participant Flow|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
474229|NCT00663858|O3|Outcome|Placebo|Placebo on Week 0, 2, 26 and 28.
474230|NCT00663858|O2|Outcome|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
474231|NCT00663858|O1|Outcome|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
474232|NCT00663858|E3|Reported Event|Placebo|Placebo on Week 0, 2, 26 and 28.
474233|NCT00663858|E2|Reported Event|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
474234|NCT00663858|E1|Reported Event|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
474235|NCT00663923|B1|Baseline|Photorefractive Keratectomy( PRK)|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to100 eyes of 50 participants)to undergo PRK by cross-cylinder or conventional(single) approach using Excimer laser.In cross-cylinder method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .In single method the steepest meridian is treated by elliptical ablation to match the flattest meridian.
474324|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474236|NCT00663923|P1|Participant Flow|Photorefractivekeratectomy(PRK)|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 100 eyes of 50 participants)to undergo PRK by cross-cylinder or conventional(single) approach using Excimer laser.In cross-cylinder method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .in single method,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
474237|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
474238|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
474239|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
474267|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
474240|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
474241|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
474242|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
474243|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
474244|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
474245|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
474246|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
474247|NCT00663923|E2|Reported Event|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
474248|NCT00663923|E1|Reported Event|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
474249|NCT00663962|B3|Baseline|Total|Total of all reporting groups
474250|NCT00663962|B2|Baseline|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
474251|NCT00663962|B1|Baseline|Pregabalin|"PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.
PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
474252|NCT00663962|P2|Participant Flow|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
474253|NCT00663962|P1|Participant Flow|Pregabalin|"PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.
PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
474254|NCT00663962|O2|Outcome|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
474255|NCT00663962|O1|Outcome|Pregabalin|"Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.
or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
474256|NCT00663962|E2|Reported Event|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
474257|NCT00663962|E1|Reported Event|Pregabalin|"Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.
or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
474258|NCT00664066|B1|Baseline|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
474259|NCT00664066|P1|Participant Flow|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
474325|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474262|NCT00664105|B1|Baseline|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
474263|NCT00664105|P1|Participant Flow|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
474264|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
474265|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
474266|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
474338|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474268|NCT00664105|E1|Reported Event|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
474269|NCT00664326|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474270|NCT00664326|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474271|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474272|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474273|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474274|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474275|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474276|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474277|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474278|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474279|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474280|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474281|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474282|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474283|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474284|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474285|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474286|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474287|NCT00664326|E1|Reported Event|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
474288|NCT00664430|B1|Baseline|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
474289|NCT00664430|P1|Participant Flow|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
474290|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
474291|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
474326|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474292|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
474293|NCT00664430|E1|Reported Event|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
474294|NCT00664521|B3|Baseline|Total|Total of all reporting groups
474295|NCT00664521|B2|Baseline|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
474296|NCT00664521|B1|Baseline|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
474297|NCT00664521|P2|Participant Flow|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
474298|NCT00664521|P1|Participant Flow|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
474299|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
474300|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
474301|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
474302|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
474303|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
474304|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
474305|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
474306|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
474307|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
474308|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
474309|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
474310|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
474311|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
474312|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
474313|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
474314|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
474315|NCT00664521|E2|Reported Event|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
474316|NCT00664521|E1|Reported Event|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
474317|NCT00664534|B3|Baseline|Total|Total of all reporting groups
474318|NCT00664534|B2|Baseline|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474319|NCT00664534|B1|Baseline|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474320|NCT00664534|P2|Participant Flow|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474321|NCT00664534|P1|Participant Flow|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474322|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474323|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474327|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474328|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474329|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474330|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474331|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474332|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474333|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474334|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474335|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474336|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474337|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474340|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474341|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474342|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
474343|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
474344|NCT00664534|E2|Reported Event|Glargine|Glargine +/- 1, 2 or 3 injections of insulin lispro plus OAMs
474345|NCT00664534|E1|Reported Event|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture) 1, 2 or 3 injections plus OAMs
474346|NCT00664560|B4|Baseline|Total|Total of all reporting groups
474347|NCT00664560|B3|Baseline|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474348|NCT00664560|B2|Baseline|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474349|NCT00664560|B1|Baseline|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474350|NCT00664560|P3|Participant Flow|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474351|NCT00664560|P2|Participant Flow|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474352|NCT00664560|P1|Participant Flow|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474353|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474354|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474355|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474356|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474357|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474358|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474359|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474360|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474361|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474362|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474363|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474364|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474365|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474366|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474367|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474368|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474369|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474370|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474371|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474372|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474373|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474374|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474375|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474376|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474377|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474378|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474379|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474380|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474381|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474382|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474383|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474384|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474385|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474386|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474387|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474388|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474389|NCT00664560|E3|Reported Event|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
474390|NCT00664560|E2|Reported Event|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
474391|NCT00664560|E1|Reported Event|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
474392|NCT00670007|B1|Baseline|Zemaira®|Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight intravenously once per week
474393|NCT00670007|P1|Participant Flow|Zemaira®|Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight administered intravenously once per week
474394|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
474395|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
474396|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
474397|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
474398|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
474399|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
474400|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
474401|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
474402|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
474403|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
474404|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
474405|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
474406|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
474407|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
474408|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
474409|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
474410|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
474411|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
474412|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
474413|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
474683|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474414|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
474415|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
474416|NCT00670007|E1|Reported Event|Zemaira®|The safety population comprised all subjects enrolled in study CE1226_3001 and who received at least 1 administration of Zemaira® during study CE1226_3001.
474417|NCT00670111|B4|Baseline|Total|Total of all reporting groups
474418|NCT00670111|B3|Baseline|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group.
474419|NCT00670111|B2|Baseline|Rate Adaptive Pacing (RAP) Off Then On|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
474420|NCT00670111|B1|Baseline|Rate Adaptive Pacing (RAP) On Then Off|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
474421|NCT00670111|P3|Participant Flow|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group.
474422|NCT00670111|P2|Participant Flow|Rate Adaptive Pacing (RAP) Off Then On|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
474464|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
474423|NCT00670111|P1|Participant Flow|Rate Adaptive Pacing (RAP) On Then Off|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
474424|NCT00670111|O2|Outcome|Rate Adaptive Pacing (RAP) Off at One Month|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
474425|NCT00670111|O1|Outcome|Rate Adaptive Pacing (RAP) On at Six Months|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
474426|NCT00670111|O2|Outcome|Rate Adaptive Pacing (RAP) Off at One Month|Rate Adaptive Pacing (RAP) Off for cardiopulmonary exercise test (CPX) at one month.
474427|NCT00670111|O1|Outcome|Rate Adaptive Pacing (RAP) On at One Month|Rate Adaptive Pacing (RAP) On for cardiopulmonary exercise test (CPX) at one month.
474428|NCT00670111|E2|Reported Event|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group. Adverse events were collected for all subjects, also for non-randomized patients.
474429|NCT00670111|E1|Reported Event|All Implanted Patients|All patients from the RAP On then Off group and from the RAP Off then On group.
474430|NCT00670202|B3|Baseline|Total|Total of all reporting groups
474431|NCT00670202|B2|Baseline|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days
Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
474432|NCT00670202|B1|Baseline|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days
Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
474433|NCT00670202|P2|Participant Flow|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days
Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
474434|NCT00670202|P1|Participant Flow|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days
Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
474435|NCT00670202|O2|Outcome|Drug: Placebo Oral Tablet|"Placebo 1 tablet three times daily x 14 days
Placebo Oral Tablet: Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days"
474436|NCT00670202|O1|Outcome|Drug: Fasudil Hydrochloride|"Fasudil hydrochloride 40 mg three times a day X 14 days
Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
474437|NCT00670202|E2|Reported Event|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days
Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
474438|NCT00670202|E1|Reported Event|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days
Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
474439|NCT00670228|B3|Baseline|Total|Total of all reporting groups
474440|NCT00670228|B2|Baseline|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
474441|NCT00670228|B1|Baseline|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
474442|NCT00670228|P2|Participant Flow|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
474443|NCT00670228|P1|Participant Flow|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
474444|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
474445|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
474446|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
474447|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
474448|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
474449|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
474450|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
474684|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474685|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|
474451|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
474452|NCT00670228|E2|Reported Event|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
474453|NCT00670228|E1|Reported Event|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
474454|NCT00670241|B4|Baseline|Total|Total of all reporting groups
474455|NCT00670241|B3|Baseline|Gel Vehicle|Gel Vehicle for up to 8 weeks
474456|NCT00670241|B2|Baseline|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
474457|NCT00670241|B1|Baseline|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
474458|NCT00670241|P3|Participant Flow|Gel Vehicle|Gel Vehicle for up to 8 weeks
474459|NCT00670241|P2|Participant Flow|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
474460|NCT00670241|P1|Participant Flow|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
474461|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
474462|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
474463|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
474466|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
474467|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
474468|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
474469|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
474470|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
474471|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
474472|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
474473|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
474474|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
474475|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
474476|NCT00670241|E3|Reported Event|Gel Vehicle|Gel Vehicle for up to 8 weeks
474477|NCT00670241|E2|Reported Event|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
474478|NCT00670241|E1|Reported Event|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
474479|NCT00670267|B1|Baseline|Open Label|nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
474480|NCT00670267|P1|Participant Flow|Open Label Treatment With Oral Nadolol|Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
474481|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
474482|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
474483|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
474484|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
474485|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|"Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in."
474486|NCT00670267|E1|Reported Event|Open Label|nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
474487|NCT00670306|B1|Baseline|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
474488|NCT00670306|P1|Participant Flow|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
474489|NCT00670306|O1|Outcome|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
474490|NCT00670306|E1|Reported Event|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
474491|NCT00670930|B3|Baseline|Total|Total of all reporting groups
474492|NCT00670930|B2|Baseline|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
474493|NCT00670930|B1|Baseline|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
474594|NCT00671528|O1|Outcome|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474494|NCT00670930|P2|Participant Flow|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
474495|NCT00670930|P1|Participant Flow|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
474496|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
474513|NCT00670956|E1|Reported Event|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart
Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
474497|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
474498|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
474499|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
474500|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
474501|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
474502|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
474503|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
474504|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
474532|NCT00671060|O1|Outcome|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
474678|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474505|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
474506|NCT00670930|E2|Reported Event|Placebo|Placebo
474507|NCT00670930|E1|Reported Event|Omalizumab|Omalizumab
474508|NCT00670956|B1|Baseline|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart
Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
474509|NCT00670956|P1|Participant Flow|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart
Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
474510|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart
Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
474511|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart
Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
474512|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart
Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
474514|NCT00670982|B3|Baseline|Total|Total of all reporting groups
474515|NCT00670982|B2|Baseline|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
474516|NCT00670982|B1|Baseline|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
474517|NCT00670982|P2|Participant Flow|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every two weeks, vinorelbine (25mg/m2) intravenously once per week, and trastuzumab(4 mg/kg) intravenously once per week.
474518|NCT00670982|P1|Participant Flow|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every 2 weeks and vinorelbine(25mg/m2) intravenously once per week, and trastuzumab (4 mg/kg) intravenously once per week
474519|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
474520|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
474521|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
474522|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
474523|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
474524|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
474525|NCT00670982|E1|Reported Event|All Study Participants|All participants received the same study treatment, so cumulative adverse events are reported here.
474526|NCT00671060|B3|Baseline|Total|Total of all reporting groups
474527|NCT00671060|B2|Baseline|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
474528|NCT00671060|B1|Baseline|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
474529|NCT00671060|P2|Participant Flow|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
474530|NCT00671060|P1|Participant Flow|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
474531|NCT00671060|O2|Outcome|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
474533|NCT00671060|E2|Reported Event|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
474534|NCT00671060|E1|Reported Event|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
474535|NCT00671177|B3|Baseline|Total|Total of all reporting groups
474536|NCT00671177|B2|Baseline|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
474537|NCT00671177|B1|Baseline|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
474538|NCT00671177|P2|Participant Flow|Standard Air Colonoscopy|"Standard Air Colonoscopy
standard air colonoscopy: air instillation in colon for visualization"
474539|NCT00671177|P1|Participant Flow|Water Immersion Colonoscopy|"Water Immersion Colonoscopy
water immersion colonoscopy: instillation of 300cc of water in the rectum"
474540|NCT00671177|O2|Outcome|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
474541|NCT00671177|O1|Outcome|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
474542|NCT00671177|O2|Outcome|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
474543|NCT00671177|O1|Outcome|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
474544|NCT00671177|O2|Outcome|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
474545|NCT00671177|O1|Outcome|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
474546|NCT00671177|E2|Reported Event|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
474547|NCT00671177|E1|Reported Event|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
474548|NCT00671437|B1|Baseline|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474549|NCT00671437|P1|Participant Flow|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474550|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474551|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474552|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474553|NCT00671437|O3|Outcome|Progressive Disease by Both CT and PET/CT|
474554|NCT00671437|O2|Outcome|Disease Control by CT and Progressive Disease by PET/CT|
474555|NCT00671437|O1|Outcome|Disease Control by CT and PET/CT|
474556|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474557|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474558|NCT00671437|O4|Outcome|Total (Overall PET Response)|
474559|NCT00671437|O3|Outcome|Progressive Metabolic Disease (Overall PET Response)|
474560|NCT00671437|O2|Outcome|Stable Metabolic Disease (Overall PET Response)|
474561|NCT00671437|O1|Outcome|Partial Metabolic Response (Overall PET Response)|
474562|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474563|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474564|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474565|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474566|NCT00671437|E1|Reported Event|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
474567|NCT00671502|B4|Baseline|Total|Total of all reporting groups
474568|NCT00671502|B3|Baseline|Placebo Tablet|tablet placebo no experimental formulation
474569|NCT00671502|B2|Baseline|Carisoprodol 500mg Tablet|tablet experimental formulation
474570|NCT00671502|B1|Baseline|Carisoprodol 700mg|tablet experimental formulation
474571|NCT00671502|P3|Participant Flow|Placebo Tablet|tablet placebo no experimental formulation
474572|NCT00671502|P2|Participant Flow|Carisoprodol 500mg Tablet|tablet experimental formulation
474573|NCT00671502|P1|Participant Flow|Carisoprodol 700mg|tablet experimental formulation
474574|NCT00671502|O3|Outcome|Placebo Tablets|placebo tablets treatment arm
474575|NCT00671502|O2|Outcome|Carisoprodol 700mg Tablets|carisoprodol 700mg tablets treatment arm
474576|NCT00671502|O1|Outcome|Carisoprodol 500mg Tablets|carisoprodol 500mg tablets treatment arm
474577|NCT00671502|E3|Reported Event|Placebo Tablet|tablet placebo no experimental formulation
474578|NCT00671502|E2|Reported Event|Carisoprodol 500mg Tablet|tablet experimental formulation
474579|NCT00671502|E1|Reported Event|Carisoprodol 700mg|tablet experimental formulation
474580|NCT00671515|B1|Baseline|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
474581|NCT00671515|P1|Participant Flow|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
474582|NCT00671515|O1|Outcome|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
474583|NCT00671515|O1|Outcome|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
474584|NCT00671515|E1|Reported Event|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
474585|NCT00671528|B4|Baseline|Total|Total of all reporting groups
474586|NCT00671528|B3|Baseline|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474587|NCT00671528|B2|Baseline|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474588|NCT00671528|B1|Baseline|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474589|NCT00671528|P3|Participant Flow|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474590|NCT00671528|P2|Participant Flow|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474591|NCT00671528|P1|Participant Flow|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474592|NCT00671528|O3|Outcome|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474593|NCT00671528|O2|Outcome|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474679|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474595|NCT00671528|O3|Outcome|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474596|NCT00671528|O2|Outcome|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474597|NCT00671528|O1|Outcome|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474598|NCT00671528|E3|Reported Event|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474599|NCT00671528|E2|Reported Event|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474639|NCT00671723|B4|Baseline|Total|Total of all reporting groups
474705|NCT00671879|E2|Reported Event|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
474600|NCT00671528|E1|Reported Event|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
474601|NCT00671554|B1|Baseline|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
474602|NCT00671554|P1|Participant Flow|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG). Four 1 ml doses of 250,000 dendritomas Subcutaneous (SQ) at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.
474603|NCT00671554|O1|Outcome|Melaxin and BCG|"Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration
Melaxin (autologous dendritoma vaccine) and BCG: Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million CFU of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration."
474604|NCT00671554|O1|Outcome|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
474605|NCT00671554|E1|Reported Event|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
474606|NCT00671606|B1|Baseline|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
474607|NCT00671606|P1|Participant Flow|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
474608|NCT00671606|O1|Outcome|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
474609|NCT00671606|E1|Reported Event|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
474610|NCT00671671|B3|Baseline|Total|Total of all reporting groups
474611|NCT00671671|B2|Baseline|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474612|NCT00671671|B1|Baseline|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474613|NCT00671671|P2|Participant Flow|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474614|NCT00671671|P1|Participant Flow|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474615|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474616|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474617|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474680|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474618|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474619|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474620|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474621|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474703|NCT00671879|O1|Outcome|Carisprodol SR 700 mg|Carisoprodol SR 700 mg twice daily
474622|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474623|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474624|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474625|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474626|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474627|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474628|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474629|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474630|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474631|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474632|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474633|NCT00671671|O1|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474634|NCT00671671|O1|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474686|NCT00671853|O1|Outcome|Quetiapine XR|
474635|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474636|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474637|NCT00671671|E2|Reported Event|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
474638|NCT00671671|E1|Reported Event|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
474640|NCT00671723|B3|Baseline|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474641|NCT00671723|B2|Baseline|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474642|NCT00671723|B1|Baseline|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474643|NCT00671723|P3|Participant Flow|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474644|NCT00671723|P2|Participant Flow|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474645|NCT00671723|P1|Participant Flow|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474646|NCT00671723|O3|Outcome|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474647|NCT00671723|O2|Outcome|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474648|NCT00671723|O1|Outcome|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474649|NCT00671723|O3|Outcome|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474650|NCT00671723|O2|Outcome|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474651|NCT00671723|O1|Outcome|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474681|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474682|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474652|NCT00671723|E3|Reported Event|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474653|NCT00671723|E2|Reported Event|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474654|NCT00671723|E1|Reported Event|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
474655|NCT00671749|B1|Baseline|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
474656|NCT00671749|P1|Participant Flow|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
474657|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
474658|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
474659|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
474660|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
474661|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
474662|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
474663|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
474664|NCT00671749|E1|Reported Event|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
474665|NCT00671788|B1|Baseline|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
474666|NCT00671788|P1|Participant Flow|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
474667|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
474668|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
474669|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
474670|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
474671|NCT00671788|E1|Reported Event|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
474672|NCT00671853|B3|Baseline|Total|Total of all reporting groups
474673|NCT00671853|B2|Baseline|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474674|NCT00671853|B1|Baseline|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474675|NCT00671853|P2|Participant Flow|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474676|NCT00671853|P1|Participant Flow|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474677|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474687|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474688|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474689|NCT00671853|E2|Reported Event|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474690|NCT00671853|E1|Reported Event|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
474691|NCT00671879|B4|Baseline|Total|Total of all reporting groups
474692|NCT00671879|B3|Baseline|Placebo|Placebo treatment arm
474693|NCT00671879|B2|Baseline|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
474694|NCT00671879|B1|Baseline|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
474695|NCT00671879|P3|Participant Flow|Placebo|Placebo treatment arm
474696|NCT00671879|P2|Participant Flow|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
474697|NCT00671879|P1|Participant Flow|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
474698|NCT00671879|O3|Outcome|Placebo|Placebo treatment arm
474699|NCT00671879|O2|Outcome|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
474700|NCT00671879|O1|Outcome|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
474701|NCT00671879|O3|Outcome|Placebo|Placebo treatment arm
474702|NCT00671879|O2|Outcome|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
474706|NCT00671879|E1|Reported Event|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
474707|NCT00671918|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
474708|NCT00671918|P1|Participant Flow|Lymphoseek, Lymphatic Mapping, Injection|Melanoma and breast cancer patients to receive a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc-99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
474709|NCT00671918|O1|Outcome|Reverse Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
474710|NCT00671918|O1|Outcome|Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
474711|NCT00671918|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
474712|NCT00671931|B6|Baseline|Total|Total of all reporting groups
474713|NCT00671931|B5|Baseline|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474714|NCT00671931|B4|Baseline|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474715|NCT00671931|B3|Baseline|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474716|NCT00671931|B2|Baseline|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474717|NCT00671931|B1|Baseline|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474718|NCT00671931|P5|Participant Flow|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474719|NCT00671931|P4|Participant Flow|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474764|NCT00672100|P2|Participant Flow|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474720|NCT00671931|P3|Participant Flow|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474721|NCT00671931|P2|Participant Flow|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474722|NCT00671931|P1|Participant Flow|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474723|NCT00671931|O5|Outcome|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474724|NCT00671931|O4|Outcome|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474725|NCT00671931|O3|Outcome|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474743|NCT00671970|O1|Outcome|Positive Expression|pMAPK positive expression
474744|NCT00671970|O2|Outcome|Negative Expression|pAKT negative expression
474745|NCT00671970|O1|Outcome|Positive Expression|pAKT positive expression
474746|NCT00671970|O2|Outcome|Loss|PTEN Loss
474747|NCT00671970|O1|Outcome|Intact|PTEN Intact
474748|NCT00671970|O2|Outcome|Negative Expression|EGFR vIII negative expression
474749|NCT00671970|O1|Outcome|Positive Expression|EGFR vIII positive expression
474750|NCT00671970|O2|Outcome|Negative Expression|EGFR negative expression
474751|NCT00671970|O1|Outcome|Positive Expression|EGFR positive expression
474726|NCT00671931|O2|Outcome|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474727|NCT00671931|O1|Outcome|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474728|NCT00671931|E5|Reported Event|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474729|NCT00671931|E4|Reported Event|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474730|NCT00671931|E3|Reported Event|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474731|NCT00671931|E2|Reported Event|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474732|NCT00671931|E1|Reported Event|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
474733|NCT00671970|B3|Baseline|Total|Total of all reporting groups
474734|NCT00671970|B2|Baseline|WHO Grade IV|WHO Grade IV Malignant Glioma
474735|NCT00671970|B1|Baseline|Who Grade III|Who Grade III Malignant Glioma
474736|NCT00671970|P2|Participant Flow|WHO Grade IV|"WHO Grade IV Malignant Glioma
Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs & 500 mg/day for pts on EIAEDs."
474737|NCT00671970|P1|Participant Flow|WHO Grade III|"WHO Grade III Malignant Glioma
Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs & 500 mg/day for pts on EIAEDs."
474738|NCT00671970|O2|Outcome|Patients Who Survived Less Than 1 Year|Patients who survived less than 1 year
474739|NCT00671970|O1|Outcome|Patients Who Survived At Least 1 Year|Patients who survived at least 1 year
474740|NCT00671970|O2|Outcome|Patients Who Survived Less Than 1 Year|Patients who survived less than 1 year
474741|NCT00671970|O1|Outcome|Patients Who Survived At Least 1 Year|Patients who survived at least 1 year
474742|NCT00671970|O2|Outcome|Negative Expression|pMAPK negative expression
474760|NCT00672100|B3|Baseline|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474761|NCT00672100|B2|Baseline|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474762|NCT00672100|B1|Baseline|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474763|NCT00672100|P3|Participant Flow|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474944|NCT00672633|B1|Baseline|Lovaza|Treatment Arm
474765|NCT00672100|P1|Participant Flow|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474766|NCT00672100|O1|Outcome|All Study Participants|All study participants who received Interscalene block (ISB) using 5-20 mL of local anesthetic.
474767|NCT00672100|O3|Outcome|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474768|NCT00672100|O2|Outcome|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474769|NCT00672100|O1|Outcome|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474770|NCT00672100|O3|Outcome|Ropivacaine 20 mL|
474771|NCT00672100|O2|Outcome|Ropivacaine 10 mL|
474772|NCT00672100|O1|Outcome|Ropivacaine 5 mL|
474773|NCT00672100|O3|Outcome|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474774|NCT00672100|O2|Outcome|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474775|NCT00672100|O1|Outcome|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474776|NCT00672100|E3|Reported Event|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474777|NCT00672100|E2|Reported Event|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474778|NCT00672100|E1|Reported Event|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
474779|NCT00672178|B1|Baseline|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
474780|NCT00672178|P1|Participant Flow|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
474781|NCT00672178|O1|Outcome|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
474782|NCT00672178|E1|Reported Event|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
474783|NCT00672204|B1|Baseline|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans
anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV
Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;
Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.
Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
474812|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474784|NCT00672204|P1|Participant Flow|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans
anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV
Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;
Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.
Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
474785|NCT00672204|O1|Outcome|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans
anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV
Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;
Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.
Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
474786|NCT00672204|E1|Reported Event|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans
anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV
Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;
Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.
Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
474950|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
474787|NCT00672243|B1|Baseline|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
474788|NCT00672243|P1|Participant Flow|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent Cytochrome P450, family 3, subfamily A (CY3PA)-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
474789|NCT00672243|O1|Outcome|Tarceva and Rapamycin|
474790|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
474791|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
474792|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
474793|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
474794|NCT00672243|E1|Reported Event|Tarceva and Rapamycin|
474795|NCT00672256|B1|Baseline|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
474796|NCT00672256|P1|Participant Flow|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
474797|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
474798|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
474799|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
474800|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
474801|NCT00672256|E1|Reported Event|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
474802|NCT00672438|B3|Baseline|Total|Total of all reporting groups
474803|NCT00672438|B2|Baseline|Saline Placebo Infusion Prior to Alfentanil Infusion|50% of participants were randomized to receive a saline placebo infusion prior to an infusion of alfentanil. All other procedures were identical in both groups.
474804|NCT00672438|B1|Baseline|Alfentanil Infusion Prior to Saline Placebo Infusion|50% of participants were randomized to receive an infusion of alfentanil prior to a saline placebo infusion. All other procedures were identical in both groups.
474805|NCT00672438|P2|Participant Flow|Saline Placebo Infusion Prior to Alfentanil Infusion|50% of participants were randomized to receive a saline placebo infusion prior to an infusion of alfentanil via a computer-controlled infusion pump targeting a steady-state plasma concentration of 100ng/ml. All other procedures were identical in both groups.
474806|NCT00672438|P1|Participant Flow|Alfentanil Infusion Prior to Saline Placebo Infusion|50% of participants were randomized to receive an infusion of alfentanil via a computer-controlled infusion targeting steady-state plasma concentration of 100ng/ml prior to a saline placebo infusion. All other procedures were identical in both groups.
474807|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
474808|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474809|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
474810|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474811|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
474813|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
474814|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474815|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
474816|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474817|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
474818|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474819|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
474820|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474821|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
474822|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474823|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
474824|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474825|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
474826|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474827|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
474828|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474829|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
474830|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474831|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
474832|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474833|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
474834|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
474835|NCT00672438|E1|Reported Event|Alfentanil|Intravenous infusion of Alfentanil
474836|NCT00672490|B3|Baseline|Total|Total of all reporting groups
474837|NCT00672490|B2|Baseline|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474838|NCT00672490|B1|Baseline|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
474839|NCT00672490|P2|Participant Flow|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474840|NCT00672490|P1|Participant Flow|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
474841|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474842|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
474843|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474844|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
474845|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474846|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
474847|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474848|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
474849|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474850|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
474851|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474852|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
474853|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474854|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
474855|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474856|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
474857|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474858|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
474859|NCT00672490|E2|Reported Event|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
474860|NCT00672490|E1|Reported Event|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
475199|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
474861|NCT00672555|B1|Baseline|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
474862|NCT00672555|P1|Participant Flow|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
474863|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
474864|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
474865|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
474866|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
474867|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
474945|NCT00672633|P2|Participant Flow|Placebo|Corn oil placebo: 4 pills/day orally for 6 months
474868|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
474869|NCT00672555|E1|Reported Event|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
474870|NCT00672594|B1|Baseline|Treatment|"Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks"
474871|NCT00672594|P1|Participant Flow|50mg Sunitinib Malate|Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
474872|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks"
474873|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks"
474874|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks"
474875|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks"
474876|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks"
474877|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks"
474878|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks"
474879|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks"
474880|NCT00672594|E1|Reported Event|50 mg Sunitinib Malate|"Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks"
474881|NCT00672620|B5|Baseline|Total|Total of all reporting groups
474882|NCT00672620|B4|Baseline|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474883|NCT00672620|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474884|NCT00672620|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474885|NCT00672620|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474886|NCT00672620|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period
474887|NCT00672620|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474888|NCT00672620|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474889|NCT00672620|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474890|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474891|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474892|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474893|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474894|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474895|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474896|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474897|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474898|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474899|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474900|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474901|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474902|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474903|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474904|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474905|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474906|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474946|NCT00672633|P1|Participant Flow|Lovaza|Treatment Arm: 4 grams/day orally for 6 months
474947|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
474907|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474908|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474909|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474910|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474911|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474912|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474913|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474914|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474915|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474916|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474917|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474918|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474919|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474920|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474921|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474922|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474923|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474924|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474925|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474926|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474927|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474928|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474929|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474930|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474931|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474932|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474933|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474934|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
475200|NCT00673231|O1|Outcome|Placebo|Placebo
476212|NCT00676585|O1|Outcome|Control|Normal Saline
474935|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474936|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474937|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474938|NCT00672620|E4|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
474939|NCT00672620|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474940|NCT00672620|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
474941|NCT00672620|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
474942|NCT00672633|B3|Baseline|Total|Total of all reporting groups
474943|NCT00672633|B2|Baseline|Placebo|Corn oil placebo
474951|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
474952|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
474953|NCT00672633|E2|Reported Event|Placebo|Corn oil placebo
474954|NCT00672633|E1|Reported Event|Lovaza|Treatment Arm
474955|NCT00672646|B4|Baseline|Total|Total of all reporting groups
474956|NCT00672646|B3|Baseline|Placebo|AZD1386 Placebo oral solution
474957|NCT00672646|B2|Baseline|Naproxen|Naproxen 500 mg capsule
474958|NCT00672646|B1|Baseline|AZD1386|AZD1386 95 mg oral solution
474959|NCT00672646|P3|Participant Flow|Placebo|AZD1386 Placebo oral solution
474960|NCT00672646|P2|Participant Flow|Naproxen|Naproxen 500 mg capsule
474961|NCT00672646|P1|Participant Flow|AZD1386|AZD1386 95 mg oral solution
474962|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
474963|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
474964|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
474965|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
474966|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
474967|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
474968|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
474969|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
474970|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
474971|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
474972|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
474973|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
474974|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
474975|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
474976|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
474977|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
474978|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
474979|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
474980|NCT00672646|E3|Reported Event|Placebo|AZD1386 Placebo oral solution
474981|NCT00672646|E2|Reported Event|Naproxen|Naproxen 500 mg capsule
474982|NCT00672646|E1|Reported Event|AZD1386|AZD1386 95 mg oral solution
474983|NCT00672737|B1|Baseline|Male Volunteers at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
474984|NCT00672737|P1|Participant Flow|Male Volunteers at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
474985|NCT00672737|O1|Outcome|Males at Risk for OSA|"Males at risk for obstructive sleep apnea were invited to have a sleep study either at home or at Stanford Sleep Center.
A week after their sleep study (Polysomnography), all volunteers underwent quantitative sensory testing in the laboratory, during which their pain thresholds and tolerances to heat (Heat pain threshold and tolerance) and cold (Cold pain threshold and tolerance) stimuli were assessed, under two different concentrations (1 and 2 mcg/mL, in randomized order) of remifentanil, a short-acting opioid, given as a computer-controlled infusion.
Remifentanil: Remifentanil was administered as a computer-controlled infusion, targeting two different effect site concentrations, 1 and 2 mcg/mL, in randomized order."
475012|NCT00672854|E2|Reported Event|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)
ClinOleic: TPN with ClinOleic (20%)"
475013|NCT00672854|E1|Reported Event|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid 20% (soybean-based)
Intralipid: TPN with Intralipid (20%)"
474986|NCT00672737|O1|Outcome|at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
474987|NCT00672737|O1|Outcome|Males at Risk for OSA|"Males at risk for obstructive sleep apnea were invited to have a sleep study either at home or at Stanford Sleep Center.
A week after their sleep study (Polysomnography), all volunteers underwent quantitative sensory testing in the laboratory, during which their pain thresholds and tolerances to heat (Heat pain threshold and tolerance) and cold (Cold pain threshold and tolerance) stimuli were assessed, under two different concentrations (1 and 2 mcg/mL, in randomized order) of remifentanil, a short-acting opioid, given as a computer-controlled infusion.
Remifentanil: Remifentanil was administered as a computer-controlled infusion, targeting two different effect site concentrations, 1 and 2 mcg/mL, in randomized order."
474988|NCT00672737|O1|Outcome|at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
475151|NCT00673075|E4|Reported Event|Carvedilol Down-Titration|Encapsulated Carvedilol Down-Titration Period
474989|NCT00672737|E1|Reported Event|at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
474990|NCT00672841|B3|Baseline|Total|Total of all reporting groups
474991|NCT00672841|B2|Baseline|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
474992|NCT00672841|B1|Baseline|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
474993|NCT00672841|P2|Participant Flow|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy (i.e., intravenous anidulafungin 200mg on day one, then 100mg daily x 14 days) initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
474994|NCT00672841|P1|Participant Flow|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
474995|NCT00672841|O2|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
474996|NCT00672841|O1|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
474997|NCT00672841|O2|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan (BDG) test for the presumptive early treatment of invasive candidiasis
474998|NCT00672841|O1|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
474999|NCT00672841|O2|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
475000|NCT00672841|O1|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
475001|NCT00672841|O2|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
475002|NCT00672841|O1|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
475003|NCT00672841|E2|Reported Event|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
475004|NCT00672841|E1|Reported Event|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
475005|NCT00672854|B3|Baseline|Total|Total of all reporting groups
475006|NCT00672854|B2|Baseline|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)
ClinOleic: TPN with ClinOleic (20%)"
475007|NCT00672854|B1|Baseline|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid (soybean-based)
Intralipid: TPN with Intralipid (20%)"
475008|NCT00672854|P2|Participant Flow|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)
ClinOleic: TPN with ClinOleic (20%)"
475009|NCT00672854|P1|Participant Flow|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid (soybean-based)
Intralipid: TPN with Intralipid (20%)"
475010|NCT00672854|O2|Outcome|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)
ClinOleic: TPN with ClinOleic (20%)"
475011|NCT00672854|O1|Outcome|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid 20% (soybean-based)
Intralipid: TPN with Intralipid (20%)"
475014|NCT00672932|B3|Baseline|Total|Total of all reporting groups
475230|NCT00673361|B1|Baseline|"Chemo-Switch Regimen"|
475015|NCT00672932|B2|Baseline|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
475016|NCT00672932|B1|Baseline|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
475017|NCT00672932|P2|Participant Flow|No Augmented Treatment Then Optional Rollover|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen. After 12 weeks, subjects in this group have the option to rollover into the raltegravir group for 12 weeks.
475018|NCT00672932|P1|Participant Flow|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
475019|NCT00672932|O2|Outcome|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
475020|NCT00672932|O1|Outcome|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
475021|NCT00672932|O2|Outcome|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
475022|NCT00672932|O1|Outcome|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
475023|NCT00672932|E2|Reported Event|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
475152|NCT00673075|E3|Reported Event|Nebivolol Down-Titration|Encapsulated Nebivolol Down-Titration Period
475024|NCT00672932|E1|Reported Event|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
475025|NCT00672958|B3|Baseline|Total|Total of all reporting groups
475026|NCT00672958|B2|Baseline|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475027|NCT00672958|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475028|NCT00672958|P2|Participant Flow|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475029|NCT00672958|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475030|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475031|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475032|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475033|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475034|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475035|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475036|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475037|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475038|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475039|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475040|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475041|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475042|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475043|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475044|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475045|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475046|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475047|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475048|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475049|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475050|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475051|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475052|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475053|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475054|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475055|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475056|NCT00672958|E2|Reported Event|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
475057|NCT00672958|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
475058|NCT00672984|B4|Baseline|Total|Total of all reporting groups
475059|NCT00672984|B3|Baseline|Placebo First|Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
475111|NCT00672984|E1|Reported Event|Guanfacine|Immediate-release Guanfacine HCl
475112|NCT00673049|B3|Baseline|Total|Total of all reporting groups
475060|NCT00672984|B2|Baseline|Moxifloxacin First|Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
475061|NCT00672984|B1|Baseline|Guanfacine First|Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
475117|NCT00673049|P2|Participant Flow|Erlotinib (Randomized to and Treated With)|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475153|NCT00673075|E2|Reported Event|Carvedilol Combined Up-Titration and Stable-dose|Encapsulated Carvedilol Combined Up-Titration and Stable-Dose Periods
475154|NCT00673075|E1|Reported Event|Nebivolol Combined Up-Titration and Stable-dose|Encapsulated Nebivolol Combined Up-Titration and Stable-Dose Periods
475062|NCT00672984|P3|Participant Flow|Placebo First|Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
475063|NCT00672984|P2|Participant Flow|Moxifloxacin First|Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
475064|NCT00672984|P1|Participant Flow|Guanfacine First|Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
475065|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475066|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
475067|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475068|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
475069|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475070|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
475071|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475072|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
475073|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475074|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
475075|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475076|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
475077|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
475078|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
475079|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475080|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
475081|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
475082|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
475083|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475084|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
475085|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
475086|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
475087|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475088|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
475089|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
475090|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
475091|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475092|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
475093|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
475094|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
475095|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475096|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
475097|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
475098|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
475099|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475100|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
475101|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
475102|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
475103|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475104|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
475105|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
475106|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
475107|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
475108|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
475109|NCT00672984|E3|Reported Event|Placebo|
475110|NCT00672984|E2|Reported Event|Moxifloxacin|Avelox, positive control
475113|NCT00673049|B2|Baseline|Erlotinib (as Randomized)|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food. Intent-to-treat population according to randomization was analyzed.
475114|NCT00673049|B1|Baseline|Figitumumab + Erlotinib (as Randomized)|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg at least 1 hour before or 2 hours after the ingestion of food. Intent-to-treat population according to randomization was analyzed.
475115|NCT00673049|P4|Participant Flow|Erlotinib, Then Figitumumab|Figitumumab 20 mg/kg was given as a single-agent therapy to participants who had disease progression on erlotinib alone. Figitumumab was administered in 3-week cycles as IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
475116|NCT00673049|P3|Participant Flow|Randomized to Figi + Erlo Arm But Treated Only With Erlo|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475150|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
475118|NCT00673049|P1|Participant Flow|Figitumumab + Erlotinib (Randomized to and Treated With)|Figitumumab ( [CP-751,871], figi) was given in combination with erlotinib (erlo) in 3-week cycles. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 milligram (mg) daily at least 1 hour before or 2 hours after the ingestion of food.
475119|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475120|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475121|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475122|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475123|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475124|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475125|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
475126|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
475127|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
475128|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
475129|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475130|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475131|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475132|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475133|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475134|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475135|NCT00673049|E3|Reported Event|Erlotinib, Then Figitumumab|Figitumumab (20 mg/kg) was given as a single agent after participants had disease progression on erlotinib alone. Figitumumab was given in 3-week cycles as IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
475136|NCT00673049|E2|Reported Event|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475194|NCT00673231|P3|Participant Flow|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
475137|NCT00673049|E1|Reported Event|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycle. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every three weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
475138|NCT00673075|B3|Baseline|Total|Total of all reporting groups
475139|NCT00673075|B2|Baseline|Carvedilol|Encapsulated Carvedilol
475140|NCT00673075|B1|Baseline|Nebivolol|Encapsulated Nebivolol
475141|NCT00673075|P2|Participant Flow|Carvedilol|Encapsulated Carvedilol
475142|NCT00673075|P1|Participant Flow|Nebivolol|Encapsulated Nebivolol
475143|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
475144|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
475145|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
475146|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
475147|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
475148|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
475149|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
475155|NCT00673114|B1|Baseline|Transplant Recipients|single arm study
475156|NCT00673114|P1|Participant Flow|Transplant Recipients|Transplant Recipients
475157|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
475158|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
475159|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
475160|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
475161|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
475162|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
475163|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
475164|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
475165|NCT00673114|E1|Reported Event|Transplant Recipients|single arm study
475166|NCT00673127|B1|Baseline|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
475167|NCT00673127|P1|Participant Flow|KHAD|KHAD; ketoconazole, hydrocortisone and dutasteride for CRPC
475168|NCT00673127|O1|Outcome|KHAD|KHAD: ketoconazole, hydrocortisone and dutasteride for CRPC
475169|NCT00673127|O1|Outcome|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
475170|NCT00673127|E1|Reported Event|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
475171|NCT00673153|B1|Baseline|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .
CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.
MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.
gemtuzumab ozogamicin: Given IV
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
475172|NCT00673153|P1|Participant Flow|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .
CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.
MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.
gemtuzumab ozogamicin: Given IV
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
475173|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .
CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.
MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.
gemtuzumab ozogamicin: Given IV
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
475174|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .
CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.
MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.
gemtuzumab ozogamicin: Given IV
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
475175|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .
CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.
MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.
gemtuzumab ozogamicin: Given IV
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
475195|NCT00673231|P2|Participant Flow|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
475196|NCT00673231|P1|Participant Flow|Placebo|Placebo
475197|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
475198|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
475231|NCT00673361|P1|Participant Flow|"Chemo-Switch Regimen"|
475176|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .
CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.
MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.
gemtuzumab ozogamicin: Given IV
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
475177|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .
CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.
MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.
gemtuzumab ozogamicin: Given IV
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
475178|NCT00673153|E1|Reported Event|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .
CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.
MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.
gemtuzumab ozogamicin: Given IV
vorinostat: Given orally
laboratory biomarker analysis: Correlative studies"
475179|NCT00673179|B3|Baseline|Total|Total of all reporting groups
475180|NCT00673179|B2|Baseline|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
475181|NCT00673179|B1|Baseline|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
475182|NCT00673179|P2|Participant Flow|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
475183|NCT00673179|P1|Participant Flow|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
475184|NCT00673179|O2|Outcome|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
475185|NCT00673179|O1|Outcome|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
475186|NCT00673179|E2|Reported Event|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days
475187|NCT00673179|E1|Reported Event|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
475188|NCT00673231|B5|Baseline|Total|Total of all reporting groups
475189|NCT00673231|B4|Baseline|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
475190|NCT00673231|B3|Baseline|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
475191|NCT00673231|B2|Baseline|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
475192|NCT00673231|B1|Baseline|Placebo|Placebo
475193|NCT00673231|P4|Participant Flow|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
475232|NCT00673361|O1|Outcome|Terminated Studybefore Accrual Goal|
475201|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
475202|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
475203|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
475204|NCT00673231|O1|Outcome|Placebo|Placebo
475205|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
475206|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
475207|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
475208|NCT00673231|O1|Outcome|Placebo|Placebo
475209|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
475210|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
475211|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
475212|NCT00673231|O1|Outcome|Placebo|Placebo
475213|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
475214|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
475215|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
475216|NCT00673231|O1|Outcome|Placebo|Placebo
475217|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
475218|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
475219|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
475220|NCT00673231|O1|Outcome|Placebo|Placebo
475221|NCT00673231|E4|Reported Event|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
475222|NCT00673231|E3|Reported Event|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
475223|NCT00673231|E2|Reported Event|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
475224|NCT00673231|E1|Reported Event|Placebo|Placebo
475225|NCT00673257|B1|Baseline|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
475226|NCT00673257|P1|Participant Flow|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
475227|NCT00673257|O1|Outcome|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
475228|NCT00673257|O1|Outcome|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
475229|NCT00673257|E1|Reported Event|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
475234|NCT00667511|B1|Baseline|Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis|"Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.
Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period."
475235|NCT00667511|P1|Participant Flow|Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis|"Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.
Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period.
In this prospective, two treatment, cross-over study, 58 End Stage Renal Disease patients >18 years of age who were currently stable on home DHD were enrolled. Enrolled patients performed Intervention 1 as the first phase of the cross-over study. Fifty-one patients completed Intervention 1 and seven patients dropped out. Forty-three patients completed the training/transition period and performed Intervention 2 as the second phase of the cross-over study. Thirty-nine patients completed Intervention 2 and four patients dropped out."
475236|NCT00667511|O2|Outcome|Home Nocturnal Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
475237|NCT00667511|O1|Outcome|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
475317|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475238|NCT00667511|O2|Outcome|Home Nocturnal Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
475239|NCT00667511|O1|Outcome|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
475240|NCT00667511|E2|Reported Event|Nocturnal Home Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
475241|NCT00667511|E1|Reported Event|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
475242|NCT00673387|B9|Baseline|Total|Total of all reporting groups
475243|NCT00673387|B8|Baseline|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475244|NCT00673387|B7|Baseline|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475245|NCT00673387|B6|Baseline|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475246|NCT00673387|B5|Baseline|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475247|NCT00673387|B4|Baseline|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475248|NCT00673387|B3|Baseline|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475249|NCT00673387|B2|Baseline|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475250|NCT00673387|B1|Baseline|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475251|NCT00673387|P8|Participant Flow|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475252|NCT00673387|P7|Participant Flow|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475253|NCT00673387|P6|Participant Flow|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475254|NCT00673387|P5|Participant Flow|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475255|NCT00673387|P4|Participant Flow|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475256|NCT00673387|P3|Participant Flow|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475257|NCT00673387|P2|Participant Flow|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475258|NCT00673387|P1|Participant Flow|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475286|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475259|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475260|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475261|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475262|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475263|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475264|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475318|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475495|NCT00673452|B2|Baseline|Placebo|oral, daily, 12 weeks
475496|NCT00673452|B1|Baseline|Duloxetine|60-120 mg, oral, daily, 12 weeks
475265|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475266|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475267|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475268|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475269|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475270|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475271|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475272|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475273|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475274|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475275|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475276|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475277|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475278|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475279|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475280|NCT00673387|O1|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475281|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475282|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475283|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475284|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475285|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475287|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475288|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475289|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475290|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475487|NCT00673400|O2|Outcome|6 Months After Surgery|outcome measured within one month before surgery
475488|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
475497|NCT00673452|P2|Participant Flow|Placebo|oral, daily, 12 weeks
475291|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475292|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475293|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475294|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475295|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475296|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475297|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475298|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475299|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475300|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475301|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475302|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475303|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475304|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475305|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475306|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475307|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475308|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475309|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475310|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475311|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475312|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475473|NCT00673400|B1|Baseline|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
475474|NCT00673400|P1|Participant Flow|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
475313|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475314|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475315|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475316|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475319|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475320|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475321|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475322|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475323|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475324|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475325|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475326|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475327|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475328|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475329|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475330|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475331|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475332|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475333|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475334|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475335|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475336|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475337|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475338|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475475|NCT00673400|O2|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
475476|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
475339|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475340|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475341|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475342|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475343|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475344|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475489|NCT00673400|E1|Reported Event|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
475345|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475346|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475347|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475348|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475349|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475350|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475351|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475352|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475353|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475354|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475355|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475356|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475357|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475358|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475359|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475360|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475361|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475362|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475363|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475364|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475365|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475366|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475367|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475368|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475369|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475370|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475490|NCT00673439|B1|Baseline|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
475491|NCT00673439|P1|Participant Flow|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
475371|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475372|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475373|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475374|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475375|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475376|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475377|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475378|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475379|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475380|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475381|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475382|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475383|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475384|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475385|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475386|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475387|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475388|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475389|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475390|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475391|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475392|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475393|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475394|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475395|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475396|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475397|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475398|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475399|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475400|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475401|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475402|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475403|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475404|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475405|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475406|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475407|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475408|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475409|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475410|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475411|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475412|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475413|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475414|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475415|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475416|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475417|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475418|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475419|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475477|NCT00673400|O4|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
475478|NCT00673400|O3|Outcome|3 Months After Surgery|outcome measured 3 months after surgery
475420|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475421|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475422|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475492|NCT00673439|O1|Outcome|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg|
475423|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475424|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475425|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475426|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475427|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475428|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475429|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475430|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475431|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475432|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475433|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475434|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475435|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475436|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475437|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475438|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475439|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475440|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475441|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475442|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475443|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475444|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475479|NCT00673400|O2|Outcome|6 Weeks After Surgery|outcome measured 6 weeks after surgery
476213|NCT00676585|O2|Outcome|Intervention|Hydrocortisone
475445|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475446|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475447|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475448|NCT00673387|O1|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475493|NCT00673439|E1|Reported Event|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
475494|NCT00673452|B3|Baseline|Total|Total of all reporting groups
475449|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475450|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475451|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475452|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475453|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475454|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475455|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475456|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475457|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475458|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475459|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475460|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
475461|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475462|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475463|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475464|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475465|NCT00673387|E8|Reported Event|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475466|NCT00673387|E7|Reported Event|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475467|NCT00673387|E6|Reported Event|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475468|NCT00673387|E5|Reported Event|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
475469|NCT00673387|E4|Reported Event|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
475470|NCT00673387|E3|Reported Event|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
475471|NCT00673387|E2|Reported Event|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
475472|NCT00673387|E1|Reported Event|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
475480|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
475481|NCT00673400|O4|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
475482|NCT00673400|O3|Outcome|3 Months After Surgery|outcome measured 3 months after surgery
475483|NCT00673400|O2|Outcome|6 Weeks After Surgery|outcome measured 6 weeks after surgery
475484|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
475485|NCT00673400|O1|Outcome|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
475486|NCT00673400|O1|Outcome|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
475498|NCT00673452|P1|Participant Flow|Duloxetine|60-120 mg, oral, daily, 12 weeks
475499|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475500|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475501|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475502|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475503|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475504|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475505|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475506|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475507|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475508|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475509|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475510|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475511|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475512|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475513|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475514|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475515|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475516|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475517|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475518|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475519|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475520|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475521|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475522|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475523|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475524|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475525|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475526|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475527|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
475528|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
475529|NCT00673452|E2|Reported Event|Placebo|oral, daily, 12 weeks
475530|NCT00673452|E1|Reported Event|Duloxetine|60-120 mg, oral, daily, 12 weeks
475531|NCT00673465|B1|Baseline|All Treated Participants|All participants received SCH 497079 for 4 weeks, placebo for 4 weeks, and metformin for 4 weeks during one of three parts of the study.
475532|NCT00673465|P12|Participant Flow|Part 2/Treatment Sequence 6: Metformin → Placebo → SCH 497079|Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks(Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
475533|NCT00673465|P11|Participant Flow|Part 2/Treatment Sequence 5: Placebo → SCH 49709 → Metformin|Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
475534|NCT00673465|P10|Participant Flow|Part 2/Treatment Sequence 4: SCH 497079 → Metformin → Placebo|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
475535|NCT00673465|P9|Participant Flow|Part 2/Treatment Sequence 3: Metformin → SCH 497079 → Placebo|Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
475536|NCT00673465|P8|Participant Flow|Part 2/Treatment Sequence 2: Placebo → Metformin → SCH 497079|Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
475537|NCT00673465|P7|Participant Flow|Part 2/Treatment Sequence 1: SCH 497079 → Placebo → Metformin|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
475538|NCT00673465|P6|Participant Flow|Part 1/Treatment Sequence 6: Metformin → Placebo → SCH 497079|Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
475539|NCT00673465|P5|Participant Flow|Part 1/Treatment Sequence 5: Placebo → SCH 49709 → Metformin|Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
475590|NCT00673595|B2|Baseline|Placebo|Participants on this arm will receive placebo tablets for 15 days.
475540|NCT00673465|P4|Participant Flow|Part 1/Treatment Sequence 4: SCH 497079 → Metformin → Placebo|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
475541|NCT00673465|P3|Participant Flow|Part 1/Treatment Sequence 3: Metformin → SCH 497079 → Placebo|Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2)followed by placebo daily for 4 weeks (Period 3).
475542|NCT00673465|P2|Participant Flow|Part 1/Treatment Sequence 2: Placebo → Metformin → SCH 497079|Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2)followed by SCH 497079 daily for 4 weeks (Period 3).
475543|NCT00673465|P1|Participant Flow|Part 1/Treatment Sequence 1: SCH 497079 → Placebo → Metformin|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
475544|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475545|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475546|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475547|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475548|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475549|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475733|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
475550|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475551|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475552|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475553|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475554|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475555|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475556|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475557|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475558|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475559|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475560|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475561|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475562|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475563|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475564|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475565|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475566|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475567|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475568|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475569|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475570|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475571|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475572|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475573|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475574|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475575|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475576|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475577|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475578|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475579|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475580|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475581|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475582|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475583|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
475584|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
475585|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475586|NCT00673465|E3|Reported Event|Metformin|Participants received metformin daily for 4 weeks during one of 3 parts of the study.
475587|NCT00673465|E2|Reported Event|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
475588|NCT00673465|E1|Reported Event|Placebo|Participants received placebo daily for 4 weeks during one of 3 parts of the study.
475589|NCT00673595|B3|Baseline|Total|Total of all reporting groups
475591|NCT00673595|B1|Baseline|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
475592|NCT00673595|P2|Participant Flow|Placebo|Participants on this arm will receive placebo tablets for 15 days.
475593|NCT00673595|P1|Participant Flow|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
475594|NCT00673595|O2|Outcome|Placebo|Participants on this arm will receive placebo tablets for 15 days.
475595|NCT00673595|O1|Outcome|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
475596|NCT00673595|O2|Outcome|Placebo|Participants on this arm will receive placebo tablets for 15 days.
475597|NCT00673595|O1|Outcome|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
475598|NCT00673595|E2|Reported Event|Placebo|Participants on this arm will receive placebo tablets for 15 days.
475599|NCT00673595|E1|Reported Event|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
475600|NCT00673660|B1|Baseline|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
475601|NCT00673660|P1|Participant Flow|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
475602|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
475636|NCT00675428|B2|Baseline|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
475603|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
475604|NCT00673660|O2|Outcome|Non-compliant With Statin Treatment|Participants with dyslipidemia who were non-compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
475605|NCT00673660|O1|Outcome|Compliant With Statin Treatment|Participants with dyslipidemia who were compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
475606|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
475607|NCT00673660|E4|Reported Event|Statins Visit 5|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
475608|NCT00673660|E3|Reported Event|Statins at Visit 4|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
475609|NCT00673660|E2|Reported Event|Statins at Visit 3|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
475610|NCT00673660|E1|Reported Event|Statins at Visit 2|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
475611|NCT00673673|B1|Baseline|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab
FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
475612|NCT00673673|P1|Participant Flow|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab
FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
475613|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab
FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
475614|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab
FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
475615|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab
FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
475616|NCT00673673|E1|Reported Event|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab
FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
475617|NCT00675259|B1|Baseline|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT (Neoadjuvant chemotherapy). Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
475672|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).
TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
475618|NCT00675259|P1|Participant Flow|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT (Neoadjuvant chemotherapy). Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
475619|NCT00675259|O3|Outcome|Patients With Hormone-responsive BC|Hormone-responsive breast cancer (BC)
475620|NCT00675259|O2|Outcome|Patients With pCR|Pathologic complete response (pCR)
475621|NCT00675259|O1|Outcome|Patients With TNBC|Women with triple negative breast cancer (TNBC)
475637|NCT00675428|B1|Baseline|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
475638|NCT00675428|P2|Participant Flow|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
475639|NCT00675428|P1|Participant Flow|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
475622|NCT00675259|O1|Outcome|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
475623|NCT00675259|O1|Outcome|Adjuvant Bevacizumab|Patients received 6 months of adjuvant bevacizumab therapy
475624|NCT00675259|O1|Outcome|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
475625|NCT00675259|E1|Reported Event|Toxicities During Neoadjuvant Chemotherapy|
475626|NCT00675415|B3|Baseline|Total|Total of all reporting groups
475627|NCT00675415|B2|Baseline|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
475628|NCT00675415|B1|Baseline|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.
In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.
This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.
Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
475629|NCT00675415|P2|Participant Flow|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
475630|NCT00675415|P1|Participant Flow|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.
In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.
This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.
Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
475631|NCT00675415|O2|Outcome|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
475632|NCT00675415|O1|Outcome|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.
In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.
This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.
Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
475710|NCT00675766|B2|Baseline|Group 2|HIV-positive adults 18-40 years old
475633|NCT00675415|E2|Reported Event|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
475634|NCT00675415|E1|Reported Event|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.
In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.
This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.
Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
475635|NCT00675428|B3|Baseline|Total|Total of all reporting groups
475640|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
475641|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
475642|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
475643|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
475644|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
475645|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
475646|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
475647|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
475648|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
475649|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
475650|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
475651|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
475652|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
475653|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
475654|NCT00675428|E2|Reported Event|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
475655|NCT00675428|E1|Reported Event|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
475656|NCT00675441|B1|Baseline|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
475657|NCT00675441|P1|Participant Flow|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
475658|NCT00675441|O1|Outcome|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
475659|NCT00675441|E1|Reported Event|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
475660|NCT00675506|B3|Baseline|Total|Total of all reporting groups
475661|NCT00675506|B2|Baseline|Placebo|"Participants received treatment with placebo medication.
Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
475662|NCT00675506|B1|Baseline|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).
Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
475663|NCT00675506|P2|Participant Flow|Placebo|"Participants received treatment with placebo medication.
Placebo : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
475664|NCT00675506|P1|Participant Flow|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).
Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
475665|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.
Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
475666|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).
TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
475667|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.
Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
475668|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).
TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
475669|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.
Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
475670|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).
TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
475671|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.
Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
475711|NCT00675766|B1|Baseline|Group 1|HIV-positive adults 50 and older
475673|NCT00675506|E2|Reported Event|Placebo|"Participants received treatment with placebo medication.
Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
475674|NCT00675506|E1|Reported Event|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).
Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
475675|NCT00675558|B4|Baseline|Total|Total of all reporting groups
475676|NCT00675558|B3|Baseline|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
475677|NCT00675558|B2|Baseline|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
475678|NCT00675558|B1|Baseline|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
475679|NCT00675558|P3|Participant Flow|Super-morbidly Obese (SMO)|"Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
10 subjects of the original 30 subjects enrolled into this group received a second bariatric procedure. The remaining 20 subjects of the original 30 subjects did not continue on to the second phase (initial bariatric surgery) of the study."
475680|NCT00675558|P2|Participant Flow|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
475681|NCT00675558|P1|Participant Flow|Non-Obese (NO)|Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
475682|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
475683|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
475684|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
475685|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
475686|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
475687|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
475688|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
475689|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
475690|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
475691|NCT00675558|E3|Reported Event|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
475692|NCT00675558|E2|Reported Event|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
475693|NCT00675558|E1|Reported Event|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
475694|NCT00675584|B3|Baseline|Total|Total of all reporting groups
475695|NCT00675584|B2|Baseline|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
475696|NCT00675584|B1|Baseline|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
475697|NCT00675584|P2|Participant Flow|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
475698|NCT00675584|P1|Participant Flow|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
475699|NCT00675584|O2|Outcome|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
475700|NCT00675584|O1|Outcome|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
475701|NCT00675584|E2|Reported Event|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
475702|NCT00675584|E1|Reported Event|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
475703|NCT00675597|B1|Baseline|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
475704|NCT00675597|P1|Participant Flow|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
475705|NCT00675597|O1|Outcome|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
475706|NCT00675597|E1|Reported Event|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
475707|NCT00675766|B5|Baseline|Total|Total of all reporting groups
475708|NCT00675766|B4|Baseline|Group 4|HIV-negative controls 18-40 years old
475709|NCT00675766|B3|Baseline|Group 3|HIV-negative controls 50 and older
475712|NCT00675766|P4|Participant Flow|Group 4|HIV-negative controls 18-40 years old
475713|NCT00675766|P3|Participant Flow|Group 3|HIV-negative controls 50 and older
475714|NCT00675766|P2|Participant Flow|Group 2|HIV-positive adults 18-40 years old
475715|NCT00675766|P1|Participant Flow|Group 1|HIV-positive adults 50 and older
475716|NCT00675766|O4|Outcome|Group 4|HIV-negative controls 18-40 years old
475717|NCT00675766|O3|Outcome|Group 3|HIV-negative controls 50 and older
475718|NCT00675766|O2|Outcome|Group 2|HIV-positive adults 18-40 years old
475719|NCT00675766|O1|Outcome|Group 1|HIV-positive adults 50 and older
475720|NCT00675766|E4|Reported Event|Group 4|HIV-negative controls 18-40 years old
475721|NCT00675766|E3|Reported Event|Group 3|HIV-negative controls 50 and older
475722|NCT00675766|E2|Reported Event|Group 2|HIV-positive adults 18-40 years old
475723|NCT00675766|E1|Reported Event|Group 1|HIV-positive adults 50 and older
475724|NCT00675792|B3|Baseline|Total|Total of all reporting groups
475725|NCT00675792|B2|Baseline|Neostigmine|50 µg/kg neostigmine
475726|NCT00675792|B1|Baseline|Sugammadex|4 mg/kg sugammadex
475727|NCT00675792|P2|Participant Flow|Neostigmine|50 µg/kg neostigmine
475728|NCT00675792|P1|Participant Flow|Sugammadex|4 mg/kg sugammadex
475729|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
475730|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
475731|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
475732|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
475734|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
475735|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
475736|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
475737|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
475738|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
475739|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
475740|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
475741|NCT00675792|E2|Reported Event|Neostigmine|50 µg/kg neostigmine
475742|NCT00675792|E1|Reported Event|Sugammadex|4 mg/kg sugammadex
475743|NCT00675909|B4|Baseline|Total|Total of all reporting groups
475744|NCT00675909|B3|Baseline|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.
Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
475745|NCT00675909|B2|Baseline|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.
0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
475746|NCT00675909|B1|Baseline|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.
0.5mg/kg of midazolam taken orally."
475747|NCT00675909|P3|Participant Flow|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.
Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
475748|NCT00675909|P2|Participant Flow|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.
0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
475749|NCT00675909|P1|Participant Flow|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.
0.5mg/kg of midazolam taken orally."
475750|NCT00675909|O3|Outcome|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.
0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
475751|NCT00675909|O2|Outcome|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.
Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
475752|NCT00675909|O1|Outcome|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.
0.5mg/kg of midazolam taken orally."
475753|NCT00675909|E3|Reported Event|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.
Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
475754|NCT00675909|E2|Reported Event|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.
0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
475755|NCT00675909|E1|Reported Event|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.
0.5mg/kg of midazolam taken orally."
475756|NCT00675922|B1|Baseline|Sulfamylon vs Silver Nitrate Solution|Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
475757|NCT00675922|P1|Participant Flow|Sulfamylon Solution 5% and Silver Nitrate Soaks|Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
475758|NCT00675922|O2|Outcome|Percent Infections: Silver Nitrate Site|Percent of sites that developed infections with Silver Nitrate soaks
475759|NCT00675922|O1|Outcome|Percent Infections:Sulfamylon Site|Percent of sites that developed infections with Sulfamylon soaks
475760|NCT00675922|E1|Reported Event|Sulfamylon Soaks, Silver Nitrate Soaks|Patients receive both treatments and each treated site is compared.
475761|NCT00675948|B3|Baseline|Total|Total of all reporting groups
475762|NCT00675948|B2|Baseline|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
475763|NCT00675948|B1|Baseline|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
475764|NCT00675948|P2|Participant Flow|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
475765|NCT00675948|P1|Participant Flow|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
475766|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
475767|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
475768|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
475769|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
475770|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
475771|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD)
475772|NCT00675948|E2|Reported Event|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
475773|NCT00675948|E1|Reported Event|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
475774|NCT00675987|B3|Baseline|Total|Total of all reporting groups
475775|NCT00675987|B2|Baseline|Placebo 1 Tab po QD|Placebo 1 tab po QD
475776|NCT00675987|B1|Baseline|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
475777|NCT00675987|P2|Participant Flow|Placebo 1 Tab po QD|Placebo 1 tab po QD
477318|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
475778|NCT00675987|P1|Participant Flow|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
475779|NCT00675987|O2|Outcome|Losartan|
475780|NCT00675987|O1|Outcome|Placebo|
475781|NCT00675987|O2|Outcome|Losartan|
475782|NCT00675987|O1|Outcome|Placebo|
475783|NCT00675987|E2|Reported Event|Placebo 1 Tab po QD|Placebo 1 tab po QD
475784|NCT00675987|E1|Reported Event|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
475785|NCT00676026|B1|Baseline|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
475786|NCT00676026|P1|Participant Flow|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
475787|NCT00676026|O1|Outcome|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
475788|NCT00676026|E1|Reported Event|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
475789|NCT00676065|B4|Baseline|Total|Total of all reporting groups
475790|NCT00676065|B3|Baseline|OC-other|Users of oral contraceptives containing other progestogens
475791|NCT00676065|B2|Baseline|OC-LNG|Users of oral contraceptives containing levonorgestrel
475792|NCT00676065|B1|Baseline|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
475793|NCT00676065|P3|Participant Flow|OC-other|Users of oral contraceptives containing other progestogens
475794|NCT00676065|P2|Participant Flow|OC-LNG|Users of oral contraceptives containing levonorgestrel
475795|NCT00676065|P1|Participant Flow|Yasmin|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
475796|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
475797|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
475798|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
475799|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
475800|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
475801|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
475802|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
475803|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
475804|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
475805|NCT00676065|E3|Reported Event|OC-other|Users of oral contraceptives containing other progestogens
475806|NCT00676065|E2|Reported Event|OC-LNG|Users of oral contraceptives containing levonorgestrel
475807|NCT00676065|E1|Reported Event|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
475808|NCT00676091|B3|Baseline|Total|Total of all reporting groups
475809|NCT00676091|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475810|NCT00676091|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475811|NCT00676091|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475812|NCT00676091|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475813|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475814|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475815|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475816|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475817|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475818|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475819|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475820|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475821|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475822|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475823|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475824|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475825|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475826|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475827|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475828|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475829|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475830|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475831|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475832|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475833|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475834|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475835|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475836|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
475837|NCT00676091|E6|Reported Event|Toddler Dose 7vPnC|"7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=64; systematic (solicited) Local Reactions N=67; systematic (solicited) Systemic Events N=86."
475838|NCT00676091|E5|Reported Event|Toddler Dose 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=81; systematic (solicited) Systemic Events N=84. Total N at Risk=155: 1 participant had no record of safety information during the Toddler dose period and was not included in the Safety population."
475839|NCT00676091|E4|Reported Event|After the Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
476020|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
475840|NCT00676091|E3|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
475841|NCT00676091|E2|Reported Event|Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).
475842|NCT00676091|E1|Reported Event|Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
475843|NCT00676130|B3|Baseline|Total|Total of all reporting groups
475844|NCT00676130|B2|Baseline|Placebo|Cephalexin plus placebo
475845|NCT00676130|B1|Baseline|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
475846|NCT00676130|P2|Participant Flow|Placebo|Cephalexin plus placebo
475847|NCT00676130|P1|Participant Flow|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
475848|NCT00676130|O2|Outcome|Placebo|Cephalexin plus placebo
475849|NCT00676130|O1|Outcome|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
475850|NCT00676130|O2|Outcome|Placebo|Cephalexin plus placebo
475851|NCT00676130|O1|Outcome|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
475852|NCT00676130|E2|Reported Event|Placebo|Cephalexin plus placebo
475853|NCT00676130|E1|Reported Event|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
475854|NCT00676143|B3|Baseline|Total|Total of all reporting groups
475939|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475855|NCT00676143|B2|Baseline|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475856|NCT00676143|B1|Baseline|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
475857|NCT00676143|P2|Participant Flow|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475858|NCT00676143|P1|Participant Flow|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
475859|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475860|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475861|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475862|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475863|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475864|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475865|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475866|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475867|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475868|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475869|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475870|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475871|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475872|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475873|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475874|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475875|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475876|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475877|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475878|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475879|NCT00676143|O2|Outcome|Bapineuzumab 0.5 mg/kg|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475880|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475881|NCT00676143|O2|Outcome|Bapineuzumab 0.5 mg/kg|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475882|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475883|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475884|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475885|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475886|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475887|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475888|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475889|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475890|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475891|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475892|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475893|NCT00676143|E2|Reported Event|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
475894|NCT00676143|E1|Reported Event|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
475895|NCT00676182|B3|Baseline|Total|Total of all reporting groups
475896|NCT00676182|B2|Baseline|Telerehabilitation TBI/PTSD|"Telerehabilitation TBI/PTSD
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI and comorbid PTSD"
475897|NCT00676182|B1|Baseline|Telerehabilitation TBI|"Telerehabilitation TBI
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI"
475898|NCT00676182|P1|Participant Flow|Telerehabilitation|"telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
475899|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
475900|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
475901|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
475902|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
475903|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for TBI/PTSD"
475904|NCT00676182|O1|Outcome|Telerehabilitation|"telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
475905|NCT00676182|O3|Outcome|Telerehabilitation 12 Months|"telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
475906|NCT00676182|O2|Outcome|Telerehabilitation 6 Months|"telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
475907|NCT00676182|O1|Outcome|Telerehabilitation Baseline|"telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
475908|NCT00676182|O1|Outcome|Telerehabilitation|"Telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects"
475909|NCT00676182|E1|Reported Event|Telerehabilitation|"telerehabilitation
Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
475910|NCT00676195|B1|Baseline|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:
Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
475911|NCT00676195|P1|Participant Flow|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:
Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
475912|NCT00676195|O1|Outcome|Open-Label|
475913|NCT00676195|O1|Outcome|Open-Label|
475914|NCT00676195|O1|Outcome|Open-Label|
475915|NCT00676195|O1|Outcome|Open-Label|
475916|NCT00676195|O1|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:
Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
475917|NCT00676195|E1|Reported Event|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:
Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
475918|NCT00676208|B3|Baseline|Total|Total of all reporting groups
475919|NCT00676208|B2|Baseline|Comparison|Medical students who do not experience Shared Medical Appointments.
475920|NCT00676208|B1|Baseline|SMA Participants|Medical Students who were assigned to observe Shared Medical Appointments (SMA).
475921|NCT00676208|P2|Participant Flow|Comparison|Medical students who do not experience Shared Medical Appointments during the study period April to August 2008.
475922|NCT00676208|P1|Participant Flow|Intervention|Medical Students who are assigned to observe Shared Medical Appointments.
475923|NCT00676208|O2|Outcome|Comparison|Medical students who do not experience Shared Medical Appointments (SMA).
475924|NCT00676208|O1|Outcome|SMA Particiants|Medical students who were assigned to observe Shared Medical Appointments (SMA).
475925|NCT00676208|O2|Outcome|Comparison|Medical Students who do not experience Shared Medical Appointments.
475926|NCT00676208|O1|Outcome|SMA Participants|Medical students who are assigned to observe Shared Medical Appointments (SMA).
475927|NCT00676208|E2|Reported Event|Comparison|Medical students who do not experience Shared Medical Appointments.
475928|NCT00676208|E1|Reported Event|SMA Participants|Medical students who were assigned to observe Shared Medical Appointments (SMA).
475929|NCT00676338|B5|Baseline|Total|Total of all reporting groups
475930|NCT00676338|B4|Baseline|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475931|NCT00676338|B3|Baseline|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475932|NCT00676338|B2|Baseline|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475933|NCT00676338|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475934|NCT00676338|P4|Participant Flow|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475935|NCT00676338|P3|Participant Flow|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475936|NCT00676338|P2|Participant Flow|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475937|NCT00676338|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475938|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
476093|NCT00676403|O1|Outcome|Placebo|
475940|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475941|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475942|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475943|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475944|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475945|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475946|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475947|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475948|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475949|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475950|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475951|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475952|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475953|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475954|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475955|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475956|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475957|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475958|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475959|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475960|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475961|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475962|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475963|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475964|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475965|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475966|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475967|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475968|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475969|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475970|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475971|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
476021|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476214|NCT00676585|O1|Outcome|Control|Normal Saline
475972|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475973|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475974|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475975|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475976|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475977|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475978|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475979|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475980|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475981|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475982|NCT00676338|E4|Reported Event|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
475983|NCT00676338|E3|Reported Event|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475984|NCT00676338|E2|Reported Event|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
475985|NCT00676338|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
475986|NCT00676364|B3|Baseline|Total|Total of all reporting groups
475987|NCT00676364|B2|Baseline|Investigational Group|Investigational group receiving blinded 4% lidocaine cream
475988|NCT00676364|B1|Baseline|ControI Group Receiving Placebo Cream Before Venipuncture|Experimential group receiving medicated topical cream prior to venipuncture
475989|NCT00676364|P2|Participant Flow|Investigational Group Receiving 4% Lidocaine|Investigational group receiving blinded 4% lidocaine cream under occlusive dressing for 15 mins prior to venipuncture
475990|NCT00676364|P1|Participant Flow|ControI Group Receiving Placebo Cream|Control group receiving blinded placebo cream under occlusive dressing prior to venipuncture
475991|NCT00676364|O2|Outcome|Investigational Group Receiving 4% Lidocaine Cream|The investigational group received blinded 4% lidocaine cream under occlusive dressing for 15 minutes prior to venipuncture.
475992|NCT00676364|O1|Outcome|ControI Group Receiving Placebo Cream|The control group received blinded placebo cream under occlusive dressing for 15 minutes prior to venipuncture.
475993|NCT00676364|O2|Outcome|Investigational Group|Investigational group receiving 4% lidocaine cream prior to venipuncture
475994|NCT00676364|O1|Outcome|ControI Group Receiving Placebo Cream|Control group receiving placebo topical cream prior to venipuncture
475995|NCT00676364|E2|Reported Event|Investigational Group|Investigational group receiving 4% lidocaine cream prior to venipuncture
475996|NCT00676364|E1|Reported Event|ControI Group Receiving Placebo Cream|Control group receiving placebo topical cream prior to venipuncture
475997|NCT00676403|B7|Baseline|Total|Total of all reporting groups
475998|NCT00676403|B6|Baseline|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
475999|NCT00676403|B5|Baseline|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476000|NCT00676403|B4|Baseline|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476001|NCT00676403|B3|Baseline|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476002|NCT00676403|B2|Baseline|Pregabalin 50 mg|Single daily 50 mg oral dose.
476003|NCT00676403|B1|Baseline|Placebo|Single daily oral dose.
476004|NCT00676403|P6|Participant Flow|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476005|NCT00676403|P5|Participant Flow|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476006|NCT00676403|P4|Participant Flow|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476007|NCT00676403|P3|Participant Flow|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476008|NCT00676403|P2|Participant Flow|Pregabalin 50 mg|Single daily 50 mg oral dose.
476009|NCT00676403|P1|Participant Flow|Placebo|Single daily oral dose.
476010|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476011|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476012|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476013|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476014|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476015|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476016|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476017|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476018|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476019|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476022|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476023|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476024|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476025|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476026|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476027|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476028|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476029|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476030|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476031|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476032|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476033|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476034|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476035|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476036|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476037|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476038|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476039|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476040|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476041|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476042|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476043|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476044|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476045|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476046|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476047|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476048|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476049|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476050|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476051|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476052|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476053|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476054|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476055|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476056|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476057|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476058|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476059|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476060|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476061|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476062|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476063|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476064|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476065|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476066|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476067|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476068|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476069|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476070|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476071|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476072|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476073|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476074|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476075|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476076|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476077|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476078|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476079|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476080|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476081|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476082|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476083|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476084|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476085|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476086|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476087|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476088|NCT00676403|O6|Outcome|Pregablin 450 mg/Day|
476089|NCT00676403|O5|Outcome|Pregabalin 300 mg/Day|
476090|NCT00676403|O4|Outcome|Pregabalin 150 mg/Day|
476091|NCT00676403|O3|Outcome|Pregabalin 100 mg/Day|
476092|NCT00676403|O2|Outcome|Pregabalin 50 mg/Day|
476094|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476095|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476096|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476097|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476098|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476099|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476100|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476101|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476102|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476103|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476104|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476105|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476106|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476107|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476108|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476109|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476110|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476111|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476112|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476113|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476114|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476115|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476116|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476117|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476118|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476119|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476120|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476121|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476122|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476123|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476124|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476125|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476126|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476127|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476128|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
476129|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
476130|NCT00676403|E6|Reported Event|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
476131|NCT00676403|E5|Reported Event|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
476132|NCT00676403|E4|Reported Event|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
476133|NCT00676403|E3|Reported Event|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
476134|NCT00676403|E2|Reported Event|Pregabalin 50 mg|Single daily 50 mg oral dose.
476135|NCT00676403|E1|Reported Event|Placebo|Single daily oral dose.
476136|NCT00676455|B1|Baseline|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
476137|NCT00676455|P1|Participant Flow|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
476138|NCT00676455|O1|Outcome|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
476139|NCT00676455|O1|Outcome|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
476140|NCT00676455|E1|Reported Event|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
476141|NCT00676494|B1|Baseline|All Patients|Patients meeting eligibility criteria and enrolled in the study.
476142|NCT00676494|P1|Participant Flow|All Patients|Patients meeting eligibility criteria and enrolled in the study.
476143|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
476144|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
476318|NCT00676897|P2|Participant Flow|Placebo Group|Placebo: Corn Starch
476145|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
476146|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
476147|NCT00676520|B1|Baseline|Subjects Receiving the XIENCE V EECSS|
476148|NCT00676520|P1|Participant Flow|Subjects Receiving the XIENCE V EECSS|
476149|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
476150|NCT00676520|O4|Outcome|Treatment Satisfaction|
476151|NCT00676520|O3|Outcome|Angina Frequency|
476152|NCT00676520|O2|Outcome|Angina Stability|
476153|NCT00676520|O1|Outcome|Physical Limitations|
476154|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
476155|NCT00676520|O4|Outcome|Treatment Satisfaction|
476156|NCT00676520|O3|Outcome|Angina Frequency|
476157|NCT00676520|O2|Outcome|Angina Stability|
476158|NCT00676520|O1|Outcome|Physical Limitations|
476159|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
476160|NCT00676520|O4|Outcome|Treatment Satisfaction|
476161|NCT00676520|O3|Outcome|Angina Frequency|
476162|NCT00676520|O2|Outcome|Angina Stability|
476163|NCT00676520|O1|Outcome|Physical Limitations|
476164|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476165|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476166|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476167|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476168|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476169|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476170|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476171|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476172|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476173|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476174|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476175|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476176|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476177|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476178|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476179|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476180|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476181|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476182|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476183|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476184|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476185|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476186|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476187|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476188|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476189|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476190|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476191|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476192|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476193|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476194|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476195|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476196|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476197|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476198|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476199|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476200|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476201|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476202|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
476203|NCT00676520|E1|Reported Event|Subjects Receiving the XIENCE V EECSS|
476204|NCT00676585|B3|Baseline|Total|Total of all reporting groups
476205|NCT00676585|B2|Baseline|Intervention|Hydrocortisone
476215|NCT00676585|E2|Reported Event|Intervention|Hydrocortisone
476216|NCT00676585|E1|Reported Event|Control|Normal Saline
476217|NCT00676650|B3|Baseline|Total|Total of all reporting groups
476218|NCT00676650|B2|Baseline|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
476219|NCT00676650|B1|Baseline|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
476220|NCT00676650|P2|Participant Flow|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
476221|NCT00676650|P1|Participant Flow|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
476319|NCT00676897|P1|Participant Flow|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
476320|NCT00676897|O2|Outcome|Placebo Group|Placebo: Corn Starch
476321|NCT00676897|O1|Outcome|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
476222|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
476223|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
476224|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
476225|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
476226|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
476227|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
476228|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
476229|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
476230|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
476231|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
476232|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
476233|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
476234|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
476235|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
476236|NCT00676650|E2|Reported Event|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
476359|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476237|NCT00676650|E1|Reported Event|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
476238|NCT00676676|B1|Baseline|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
476239|NCT00676676|P1|Participant Flow|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
476240|NCT00676676|O1|Outcome|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
476241|NCT00676676|E1|Reported Event|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
476242|NCT00676689|B1|Baseline|SAPIEN THV|
476243|NCT00676689|P1|Participant Flow|SAPIEN THV|
476244|NCT00676689|O1|Outcome|SAPIEN THV|
476245|NCT00676689|O1|Outcome|SAPIEN THV|
476246|NCT00676689|O1|Outcome|SAPIEN THV|
476247|NCT00676689|E1|Reported Event|SAPIEN THV|
476248|NCT00676715|B5|Baseline|Total|Total of all reporting groups
476249|NCT00676715|B4|Baseline|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476322|NCT00676897|O2|Outcome|Placebo Group|Placebo: Corn Starch
476250|NCT00676715|B3|Baseline|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
476251|NCT00676715|B2|Baseline|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476252|NCT00676715|B1|Baseline|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
476253|NCT00676715|P4|Participant Flow|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476254|NCT00676715|P3|Participant Flow|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
476255|NCT00676715|P2|Participant Flow|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476256|NCT00676715|P1|Participant Flow|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
476257|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476258|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
476259|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476260|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
476261|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476262|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
476263|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476264|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
476265|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476266|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
476267|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476268|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
476269|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476323|NCT00676897|O1|Outcome|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
476324|NCT00676897|E2|Reported Event|Placebo Group|Placebo: Corn Starch
476270|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
476271|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476272|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
476273|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476274|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
476275|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476276|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
476277|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476278|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
476279|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476280|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
476281|NCT00676715|E4|Reported Event|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476282|NCT00676715|E3|Reported Event|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
476283|NCT00676715|E2|Reported Event|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
476284|NCT00676715|E1|Reported Event|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
476285|NCT00676780|B1|Baseline|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
476356|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476286|NCT00676780|P1|Participant Flow|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
476287|NCT00676780|O1|Outcome|ECGC Extract|Epigallocatechin Gallate (ECGC) Single arm for a phase II study.
476288|NCT00676780|O1|Outcome|ECGC Extract|Single arm for a phase II study of the effects of ECGC polyphenol extract from green tea on biomarkers in patients with prostate cancer.
476289|NCT00676780|O1|Outcome|ECGC Extract|Single arm for a phase II study of the effects of Epigallocatechin Gallate (ECGC) polyphenol extract from green tea on biomarkers in patients with prostate cancer.
476290|NCT00676780|E1|Reported Event|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
476325|NCT00676897|E1|Reported Event|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
476326|NCT00677014|B4|Baseline|Total|Total of all reporting groups
476291|NCT00676793|B1|Baseline|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
476292|NCT00676793|P1|Participant Flow|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
476293|NCT00676793|O1|Outcome|ECGC and Breast Cancer|The effect of ECGC extract on biomarkers in breast cancer.
476294|NCT00676793|O1|Outcome|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
476295|NCT00676793|E1|Reported Event|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
476296|NCT00676806|B3|Baseline|Total|Total of all reporting groups
476297|NCT00676806|B2|Baseline|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
476298|NCT00676806|B1|Baseline|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning
Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
476299|NCT00676806|P2|Participant Flow|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
476300|NCT00676806|P1|Participant Flow|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning
Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
476301|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
1/2 evaluable subjects engrafted at +45 and +90 days. 3 evaluable subjects for toxicity."
476302|NCT00676806|O1|Outcome|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
2/2 evaluable subjects engrafted at +45 and +90 days. 3 evaluable subjects for toxicity."
476303|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
476304|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
476305|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
476306|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
476307|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
476308|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
476309|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
476310|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
476311|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
1/2 evaluable subjects engrafted at +45 and +90 days."
476312|NCT00676806|O1|Outcome|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
2/2 evaluable subjects engrafted at +45 and +90 days."
476357|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476358|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476313|NCT00676806|E2|Reported Event|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
476314|NCT00676806|E1|Reported Event|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning
Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
476315|NCT00676897|B3|Baseline|Total|Total of all reporting groups
476316|NCT00676897|B2|Baseline|Placebo Group|Placebo: Corn Starch
476317|NCT00676897|B1|Baseline|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
476327|NCT00677014|B3|Baseline|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
476328|NCT00677014|B2|Baseline|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
476329|NCT00677014|B1|Baseline|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
476330|NCT00677014|P3|Participant Flow|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
476331|NCT00677014|P2|Participant Flow|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
476332|NCT00677014|P1|Participant Flow|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
476333|NCT00677014|O3|Outcome|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
476334|NCT00677014|O2|Outcome|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
476335|NCT00677014|O1|Outcome|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
476336|NCT00677014|E3|Reported Event|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
476337|NCT00677014|E2|Reported Event|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
476338|NCT00677014|E1|Reported Event|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
476339|NCT00677092|B1|Baseline|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
476340|NCT00677092|P1|Participant Flow|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if participant developed gastrointestinal intolerance or alopecia.
476341|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
476342|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
476343|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
476344|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
476345|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
476346|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 milligrams (mg) orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
476347|NCT00677092|E1|Reported Event|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
476348|NCT00677235|B3|Baseline|Total|Total of all reporting groups
476349|NCT00677235|B2|Baseline|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476350|NCT00677235|B1|Baseline|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476351|NCT00677235|P2|Participant Flow|PTA Only|Percutaneous Transluminal Angioplasty (PTA): Treatment of stenoses with PTA only
476352|NCT00677235|P1|Participant Flow|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476353|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476354|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476355|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476450|NCT00677534|P1|Participant Flow|Cholecalciferol 50,000 U|Vitamin D
476360|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476361|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476362|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476363|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476364|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476365|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476366|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476367|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476368|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476369|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476370|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476371|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476372|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476373|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476374|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476375|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476376|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476377|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476378|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476379|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476380|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476381|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476382|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476383|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476384|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476385|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476386|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476387|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476388|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476389|NCT00677235|E2|Reported Event|PTA Only|"Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only"
476390|NCT00677235|E1|Reported Event|FLAIR|"FLAIR Endovascular Stent Graft
FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
476391|NCT00677352|B3|Baseline|Total|Total of all reporting groups
476392|NCT00677352|B2|Baseline|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.
At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
476393|NCT00677352|B1|Baseline|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.
At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
476394|NCT00677352|P2|Participant Flow|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.
At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
476451|NCT00677534|O1|Outcome|Cholecalciferol 50,000 U|Vitamin D
476395|NCT00677352|P1|Participant Flow|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.
At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
476396|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.
At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
476397|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.
At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
476468|NCT00677690|E2|Reported Event|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
477319|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
476398|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.
At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
476399|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.
At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
476400|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.
At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
476401|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.
At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
476402|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.
At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
476403|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.
At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
476404|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.
At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
476405|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.
At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
476452|NCT00677534|E1|Reported Event|Cholecalciferol 50,000 U|Vitamin D
476453|NCT00677690|B3|Baseline|Total|Total of all reporting groups
476454|NCT00677690|B2|Baseline|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
476455|NCT00677690|B1|Baseline|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
478687|NCT00683618|B2|Baseline|Rosuvastatin 10mg|Taken orally once daily
476406|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.
At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
476407|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.
At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
476408|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.
At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
476409|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.
At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
476410|NCT00677352|E2|Reported Event|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.
At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
476411|NCT00677352|E1|Reported Event|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.
At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
476412|NCT00677365|B5|Baseline|Total|Total of all reporting groups
476413|NCT00677365|B4|Baseline|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
476414|NCT00677365|B3|Baseline|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
476415|NCT00677365|B2|Baseline|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
476416|NCT00677365|B1|Baseline|Placebo|Placebo Group
476417|NCT00677365|P4|Participant Flow|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
476418|NCT00677365|P3|Participant Flow|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
476419|NCT00677365|P2|Participant Flow|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
476420|NCT00677365|P1|Participant Flow|Placebo|Placebo Group
476421|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
476422|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
476423|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
476424|NCT00677365|O1|Outcome|Placebo|Placebo Group
476425|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
476426|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
476427|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
476428|NCT00677365|O1|Outcome|Placebo|Placebo Group
476429|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
476430|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
476431|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
476432|NCT00677365|O1|Outcome|Placebo|Placebo Group
476433|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
476434|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
476435|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
476436|NCT00677365|O1|Outcome|Placebo|Placebo Group
476437|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
476438|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
476439|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
476440|NCT00677365|O1|Outcome|Placebo|Placebo Group
476441|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
476442|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
476443|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
476444|NCT00677365|O1|Outcome|Placebo|Placebo Group
476445|NCT00677365|E4|Reported Event|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
476446|NCT00677365|E3|Reported Event|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
476447|NCT00677365|E2|Reported Event|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
476448|NCT00677365|E1|Reported Event|Placebo|Placebo Group
476449|NCT00677534|B1|Baseline|Cholecalciferol 50,000 U|Vitamin D
476456|NCT00677690|P2|Participant Flow|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
476457|NCT00677690|P1|Participant Flow|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
476458|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
476459|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
476460|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
476461|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
476462|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
476463|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
476464|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
476465|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
476466|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
476467|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
476469|NCT00677690|E1|Reported Event|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
476470|NCT00670449|B5|Baseline|Total|Total of all reporting groups
476471|NCT00670449|B4|Baseline|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
476472|NCT00670449|B3|Baseline|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
476473|NCT00670449|B2|Baseline|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
476474|NCT00670449|B1|Baseline|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
476475|NCT00670449|P4|Participant Flow|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
476476|NCT00670449|P3|Participant Flow|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
476477|NCT00670449|P2|Participant Flow|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
476478|NCT00670449|P1|Participant Flow|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
476479|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
476480|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
476481|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
476482|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
476483|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
476484|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
476485|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
476486|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
476487|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
476488|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
476489|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
476490|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
476491|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
476492|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
476493|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
476494|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
476495|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
476496|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
476497|NCT00670449|E4|Reported Event|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
476498|NCT00670449|E3|Reported Event|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
476499|NCT00670449|E2|Reported Event|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
476500|NCT00670449|E1|Reported Event|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
476501|NCT00670462|B3|Baseline|Total|Total of all reporting groups
476604|NCT00677807|B3|Baseline|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476605|NCT00677807|B2|Baseline|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476606|NCT00677807|B1|Baseline|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476502|NCT00670462|B2|Baseline|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.
weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
476503|NCT00670462|B1|Baseline|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
476504|NCT00670462|P2|Participant Flow|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.
weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
476505|NCT00670462|P1|Participant Flow|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
476506|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
476507|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
476508|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
476509|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
477457|NCT00680797|B2|Baseline|+T -E|"+Testosterone, -Estrogen
Testosterone: Testosterone gel"
476510|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
476607|NCT00677807|P3|Participant Flow|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476608|NCT00677807|P2|Participant Flow|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
477960|NCT00674700|O3|Outcome|Placebo|Placebo tablet
476511|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
476512|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
476513|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
476514|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.
weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
476515|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
476516|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.
weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
476517|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
476518|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.
weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
476519|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
476520|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.
weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
476808|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
476521|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
476522|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
476523|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
476524|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.
weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
476525|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
476526|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.
weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
476527|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
476528|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.
weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
476529|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
476558|NCT00670709|E1|Reported Event|Huntington Disease|Subjects with mild or moderate Huntington's Disease
476559|NCT00670748|B5|Baseline|Total|Total of all reporting groups
476530|NCT00670462|E2|Reported Event|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.
weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
476531|NCT00670462|E1|Reported Event|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
476532|NCT00670540|B1|Baseline|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
476533|NCT00670540|P1|Participant Flow|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
476534|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
476535|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
476536|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
476537|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
476538|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
476539|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
476540|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
476541|NCT00670540|E1|Reported Event|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
476548|NCT00670709|B3|Baseline|Total|Total of all reporting groups
476549|NCT00670709|B2|Baseline|Healthy Controls|Healthy control subjects
476550|NCT00670709|B1|Baseline|Huntington Disease|Subjects with mild or moderate Huntington's Disease
476551|NCT00670709|P2|Participant Flow|Healthy Controls|Healthy control subjects
476552|NCT00670709|P1|Participant Flow|Huntington Disease|Subjects with mild or moderate Huntington's Disease
476553|NCT00670709|O2|Outcome|Healthy Controls|Healthy control subjects
476554|NCT00670709|O1|Outcome|Huntington Disease|Subjects with mild or moderate Huntington's Disease
476555|NCT00670709|O2|Outcome|Healthy Controls|Healthy control subjects
476556|NCT00670709|O1|Outcome|Huntington Disease|Subjects with mild or moderate Huntington's Disease
476557|NCT00670709|E2|Reported Event|Healthy Controls|Healthy control subjects
476560|NCT00670748|B4|Baseline|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
476561|NCT00670748|B3|Baseline|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
476562|NCT00670748|B2|Baseline|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476563|NCT00670748|B1|Baseline|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476609|NCT00677807|P1|Participant Flow|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476610|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476564|NCT00670748|P4|Participant Flow|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
476565|NCT00670748|P3|Participant Flow|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
476566|NCT00670748|P2|Participant Flow|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476592|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
476624|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476567|NCT00670748|P1|Participant Flow|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476568|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
476569|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
476570|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476571|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476572|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
476573|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
476593|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
476625|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476574|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476575|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476576|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
476577|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
476578|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476579|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476580|NCT00670748|E4|Reported Event|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
476594|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
476626|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
478688|NCT00683618|B1|Baseline|Rosuvastatin 5mg|Taken orally once daily
476581|NCT00670748|E3|Reported Event|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
476582|NCT00670748|E2|Reported Event|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476583|NCT00670748|E1|Reported Event|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
476584|NCT00670800|B3|Baseline|Total|Total of all reporting groups
476611|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476612|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476613|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476614|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476585|NCT00670800|B2|Baseline|Normal Controls|Normal controls are matched for age and education and screened for insulin resistance. Controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles, and lack hirsutism and acne. Exclusion criteria: Left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, claustrophobia, contraindications to MRI (including pacemakers, pumps, surgical clips or metallic surgical devices), smoking within the last 6 months, use of hormones or insulin sensitizing mediation within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids, cardiac or pulmonary insufficiency, active liver disease and transaminases elevations >2.5 X normal values, renal insufficiency (plasma creatinine level ≥1.4 mg/dl), use of centrally acting medications, allergy to any opioid medication, 300 lbs maximum weight limit (which is the max
476586|NCT00670800|B1|Baseline|PCOS Affected Women - Metformin|Right handed women who don’t smoke and who drink very little will be considered eligible. Women with the following conditions (exclusion criteria) may not participate: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics).
476587|NCT00670800|P2|Participant Flow|Women Controls Without PCOS|"Control group is comprised of subjects without PCOS. These women have normal menstrual cycles and no evidence of insulin resistance (fasting HOMA2 IR of 80%S or more).
Exclusion criteria: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics)."
476588|NCT00670800|P1|Participant Flow|Women Affected With PCOS - Metformin|The Polycystic Ovary Syndrome (PCOS) affected group is comprised of subjects with insulin resistant PCOS, defined as having irregular menstrual cycles and hyperandrogenism with other causes ruled out. Insulin resistance will be identified as fasting homeostasis model assessment insulin resistance (HOMA2-IR) of 60%S or less.
476589|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
476590|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
476591|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
476737|NCT00677924|O2|Outcome|Zalutumumab 16 mg/kg|
476738|NCT00677924|O1|Outcome|Zalatumumab 8 mg/kg|
476739|NCT00677924|O2|Outcome|Zalutumumab 16 mg/kg|
476595|NCT00670800|O3|Outcome|Normal Control Women|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
476596|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
476597|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
476598|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
476599|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
476600|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
476601|NCT00670800|E2|Reported Event|PCOS Affected Women on Metformin|Women with PCOS and insulin resistance
476602|NCT00670800|E1|Reported Event|Normal Controls|Women without PCOS
476603|NCT00677807|B4|Baseline|Total|Total of all reporting groups
476804|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476615|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476616|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476617|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476618|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476619|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476620|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476621|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476622|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476623|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476740|NCT00677924|O1|Outcome|Zalatumumab 8 mg/kg|
476741|NCT00677924|E2|Reported Event|Zalutumumab 16 mg/kg|
476627|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476628|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476629|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476630|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476631|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476632|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476633|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476634|NCT00677807|E3|Reported Event|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476635|NCT00677807|E2|Reported Event|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476636|NCT00677807|E1|Reported Event|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
476637|NCT00677820|B3|Baseline|Total|Total of all reporting groups
476638|NCT00677820|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
476639|NCT00677820|B1|Baseline|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
476640|NCT00677820|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
476641|NCT00677820|P1|Participant Flow|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
476642|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
476643|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
476644|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
476645|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
476646|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
476647|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
476648|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
476649|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
476650|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
476651|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
476652|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
476653|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
476654|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
476655|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
476656|NCT00677820|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
476657|NCT00677820|E1|Reported Event|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
476658|NCT00677833|B5|Baseline|Total|Total of all reporting groups
476659|NCT00677833|B4|Baseline|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476660|NCT00677833|B3|Baseline|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476661|NCT00677833|B2|Baseline|Cohort 1: Artemether + Lumefantrine|"Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2.
Cohort 1 included participants between >=5 years of age and <=12 years of age."
476662|NCT00677833|B1|Baseline|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between >=5 years of age and <=12 years of age.
476663|NCT00677833|P4|Participant Flow|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476664|NCT00677833|P3|Participant Flow|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476665|NCT00677833|P2|Participant Flow|Cohort 1: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age.
476805|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476806|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476666|NCT00677833|P1|Participant Flow|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between greater than or equal to (>=) 5 years of age and less than or equal to (<=) 12 years of age.
476667|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476668|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476669|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476670|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476742|NCT00677924|E1|Reported Event|Zalatumumab 8 mg/kg|
476827|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476671|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476672|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476673|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476674|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476675|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476676|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476677|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476678|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476679|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476680|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476681|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476682|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
477320|NCT00680186|E2|Reported Event|Warfarin|PRN to maintain an INR of 2.0-3.0
476683|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476684|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476685|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476686|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476687|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476688|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476870|NCT00679263|B4|Baseline|Total|Total of all reporting groups
476689|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476690|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476691|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476692|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476693|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476694|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476695|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476696|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476697|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476698|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476699|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476700|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476701|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476702|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476703|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476704|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476705|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476706|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
478703|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
476707|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476708|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476709|NCT00677833|E4|Reported Event|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476710|NCT00677833|E3|Reported Event|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
476711|NCT00677833|E2|Reported Event|Cohort 1: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age.
476712|NCT00677833|E1|Reported Event|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base). Cohort 1 included participants between >=5 years of age and <=12 years of age.
476713|NCT00677898|B3|Baseline|Total|Total of all reporting groups
476714|NCT00677898|B2|Baseline|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
476715|NCT00677898|B1|Baseline|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
476716|NCT00677898|P2|Participant Flow|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
476717|NCT00677898|P1|Participant Flow|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
476718|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
476719|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
476720|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
476721|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
476722|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
476807|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476723|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
476724|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
476725|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
476726|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
476727|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
476728|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
476729|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
476730|NCT00677898|E2|Reported Event|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
476731|NCT00677898|E1|Reported Event|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
476732|NCT00677924|B3|Baseline|Total|Total of all reporting groups
476733|NCT00677924|B2|Baseline|Zalutumumab 16 mg/kg|
476734|NCT00677924|B1|Baseline|Zalatumumab 8 mg/kg|
476735|NCT00677924|P2|Participant Flow|Zalutumumab 16 mg/kg|
476736|NCT00677924|P1|Participant Flow|Zalatumumab 8 mg/kg|
476743|NCT00678015|B1|Baseline|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
476744|NCT00678015|P1|Participant Flow|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
476745|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
476746|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
476747|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
476748|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
476749|NCT00678015|E1|Reported Event|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
476750|NCT00678041|B3|Baseline|Total|Total of all reporting groups
476751|NCT00678041|B2|Baseline|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC
Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
476752|NCT00678041|B1|Baseline|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC
Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
476753|NCT00678041|P2|Participant Flow|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC
Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
476754|NCT00678041|P1|Participant Flow|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC
Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
476755|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
476756|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
476757|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
476758|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
476759|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
476760|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
476761|NCT00678041|O2|Outcome|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC
Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
476762|NCT00678041|O1|Outcome|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC
Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
476763|NCT00678041|E2|Reported Event|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC
Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
476764|NCT00678041|E1|Reported Event|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC
Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
476765|NCT00679055|B3|Baseline|Total|Total of all reporting groups
476766|NCT00679055|B2|Baseline|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
476767|NCT00679055|B1|Baseline|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
476768|NCT00679055|P2|Participant Flow|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
476769|NCT00679055|P1|Participant Flow|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
476770|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
476771|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
476772|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
476773|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
476774|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
476775|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
476776|NCT00679055|E2|Reported Event|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
476777|NCT00679055|E1|Reported Event|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
476824|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476825|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476826|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476778|NCT00679081|B1|Baseline|CelTx and Autologous CTG; Split-mouth Design|Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
476779|NCT00679081|P1|Participant Flow|CelTx and Autologous CTG; Split-mouth Design|Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
476780|NCT00679081|O3|Outcome|Other Location|Adverse events occurring at a site other than the CelTx or Autologous graft sites
476781|NCT00679081|O2|Outcome|Graft Site|Adverse events occurring at the autologous sub-epithelial connective tissue graft site
476782|NCT00679081|O1|Outcome|CelTx Site|Adverse events occurring at the CelTx site
476783|NCT00679081|E3|Reported Event|Other Location|Adverse events occurring at a site other than the CelTx or Autologous graft sites
476784|NCT00679081|E2|Reported Event|Graft Site|Adverse events occurring at the autologous sub-epithelial connective tissue graft site
476785|NCT00679081|E1|Reported Event|CelTx Site|Adverse events occurring at the CelTx site
476786|NCT00679172|B6|Baseline|Total|Total of all reporting groups
476787|NCT00679172|B5|Baseline|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
476788|NCT00679172|B4|Baseline|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476789|NCT00679172|B3|Baseline|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476790|NCT00679172|B2|Baseline|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476791|NCT00679172|B1|Baseline|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476792|NCT00679172|P5|Participant Flow|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
476793|NCT00679172|P4|Participant Flow|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476794|NCT00679172|P3|Participant Flow|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476795|NCT00679172|P2|Participant Flow|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476796|NCT00679172|P1|Participant Flow|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476797|NCT00679172|O2|Outcome|Placebo - Cohort 2|Placebo comparator comprised of excipients only - Cohort 2
476798|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476799|NCT00679172|O2|Outcome|Placebo - Cohort 2|Placebo comparator comprised of excipients only - Cohort 2
476800|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476801|NCT00679172|O2|Outcome|Placebo - Cohort 2|Placebo comparator comprised of excipients only - Cohort 2
476802|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476803|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
477321|NCT00680186|E1|Reported Event|Dabigatran 150 mg|bid oral
476809|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476810|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476811|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476812|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476813|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
476814|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476815|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476816|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476817|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476818|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
476819|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC- ssaV-) ZH9.
476820|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476821|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476822|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476823|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
478704|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
476828|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
476829|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476830|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476831|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476832|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476833|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
476834|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476835|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476836|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476837|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476838|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
476839|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476840|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476841|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476842|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476843|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
476844|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476845|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476846|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476847|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476848|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
476849|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476850|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476851|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476852|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476853|NCT00679172|E5|Reported Event|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
476854|NCT00679172|E4|Reported Event|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476855|NCT00679172|E3|Reported Event|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476856|NCT00679172|E2|Reported Event|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476857|NCT00679172|E1|Reported Event|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
476858|NCT00679211|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476859|NCT00679211|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476860|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476861|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476862|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476863|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476864|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476865|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476866|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476867|NCT00679211|O2|Outcome|9 Months of Follow-up|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476868|NCT00679211|O1|Outcome|6 Months of Follow-up|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476869|NCT00679211|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
476871|NCT00679263|B3|Baseline|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
476872|NCT00679263|B2|Baseline|Placebo|MN-221 Placebo continuous infusion
476873|NCT00679263|B1|Baseline|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
476874|NCT00679263|P3|Participant Flow|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
476875|NCT00679263|P2|Participant Flow|Placebo|MN-221 Placebo continuous infusion
476876|NCT00679263|P1|Participant Flow|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
476877|NCT00679263|O3|Outcome|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
476878|NCT00679263|O2|Outcome|Placebo|MN-221 Placebo continuous infusion
476879|NCT00679263|O1|Outcome|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
476880|NCT00679263|O3|Outcome|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
476881|NCT00679263|O2|Outcome|Placebo|MN-221 Placebo continuous infusion
476882|NCT00679263|O1|Outcome|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
476883|NCT00679263|E3|Reported Event|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
476884|NCT00679263|E2|Reported Event|Placebo|MN-221 Placebo continuous infusion
476885|NCT00679263|E1|Reported Event|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
476886|NCT00679302|B3|Baseline|Total|Total of all reporting groups
476887|NCT00679302|B2|Baseline|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
476888|NCT00679302|B1|Baseline|Placebo Group|Maalox and bitter mixture
476889|NCT00679302|P2|Participant Flow|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
476890|NCT00679302|P1|Participant Flow|Placebo Group|Maalox and bitter mixture
476891|NCT00679302|O2|Outcome|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
476892|NCT00679302|O1|Outcome|Placebo Group|Maalox and bitter mixture
476893|NCT00679302|O2|Outcome|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
476894|NCT00679302|O1|Outcome|Placebo Group|Maalox and bitter mixture
476895|NCT00679302|E2|Reported Event|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
476896|NCT00679302|E1|Reported Event|Placebo Group|Maalox and bitter mixture
476897|NCT00679341|B3|Baseline|Total|Total of all reporting groups
476898|NCT00679341|B2|Baseline|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
476899|NCT00679341|B1|Baseline|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
476900|NCT00679341|P2|Participant Flow|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
476901|NCT00679341|P1|Participant Flow|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
476902|NCT00679341|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
476903|NCT00679341|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
476904|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
478753|NCT00683657|E2|Reported Event|SAXA 5MG + MET|
476905|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
476906|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
476907|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
476908|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
476909|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
476910|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
476911|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
476912|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
476913|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
478705|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
476914|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
476915|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
476916|NCT00679341|E2|Reported Event|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
476917|NCT00679341|E1|Reported Event|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
476918|NCT00679354|B1|Baseline|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
476919|NCT00679354|P1|Participant Flow|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
476920|NCT00679354|O1|Outcome|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
476921|NCT00679354|E1|Reported Event|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cilengitide: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies"
476922|NCT00679367|B1|Baseline|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4"
476923|NCT00679367|P1|Participant Flow|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4"
476924|NCT00679367|O1|Outcome|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day days 1-21
melphalan: 5 mg/m2 days 1-4"
476925|NCT00679367|O1|Outcome|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4"
476926|NCT00679367|O1|Outcome|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4"
476927|NCT00679367|E1|Reported Event|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone
dexamethasone: 40 mg once weekly
lenalidomide: 10 mg/day Days 1-21
melphalan: 5 mg/m2 Days 1-4"
476928|NCT00679380|B5|Baseline|Total|Total of all reporting groups
476929|NCT00679380|B4|Baseline|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
476930|NCT00679380|B3|Baseline|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
476931|NCT00679380|B2|Baseline|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476932|NCT00679380|B1|Baseline|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476933|NCT00679380|P4|Participant Flow|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
476934|NCT00679380|P3|Participant Flow|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
477869|NCT00674466|O3|Outcome|Placebo|"Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week"
476935|NCT00679380|P2|Participant Flow|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476936|NCT00679380|P1|Participant Flow|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476937|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
476938|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
476939|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476940|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476941|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
476942|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
476943|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476944|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476945|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
476946|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
477656|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
476947|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476948|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476949|NCT00679380|E4|Reported Event|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
476950|NCT00679380|E3|Reported Event|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
476951|NCT00679380|E2|Reported Event|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476952|NCT00679380|E1|Reported Event|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
476953|NCT00679432|B5|Baseline|Total|Total of all reporting groups
476954|NCT00679432|B4|Baseline|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476955|NCT00679432|B3|Baseline|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476956|NCT00679432|B2|Baseline|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
476957|NCT00679432|B1|Baseline|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476958|NCT00679432|P4|Participant Flow|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476959|NCT00679432|P3|Participant Flow|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476960|NCT00679432|P2|Participant Flow|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
476961|NCT00679432|P1|Participant Flow|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476962|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476963|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476964|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
476965|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476966|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
477330|NCT00680316|P2|Participant Flow|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
476967|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476968|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
476969|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476970|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476971|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476972|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
476973|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476974|NCT00679432|E4|Reported Event|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476975|NCT00679432|E3|Reported Event|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476976|NCT00679432|E2|Reported Event|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
477014|NCT00679783|P4|Participant Flow|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477358|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)
Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
476977|NCT00679432|E1|Reported Event|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
476978|NCT00679627|B3|Baseline|Total|Total of all reporting groups
476979|NCT00679627|B2|Baseline|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
476980|NCT00679627|B1|Baseline|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
476981|NCT00679627|P2|Participant Flow|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
476982|NCT00679627|P1|Participant Flow|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
476998|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
476983|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
476984|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
476985|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
476986|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
476987|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
476988|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
476989|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
476990|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
476991|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
476992|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
476993|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
476994|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
476995|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
476996|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
476997|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
477025|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
477741|NCT00674115|E5|Reported Event|Prilosec (1-Day Dosing)|
476999|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
477000|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
477001|NCT00679627|E2|Reported Event|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
477002|NCT00679627|E1|Reported Event|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
477003|NCT00679783|B8|Baseline|Total|Total of all reporting groups
477004|NCT00679783|B7|Baseline|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
477005|NCT00679783|B6|Baseline|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
477006|NCT00679783|B5|Baseline|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
477007|NCT00679783|B4|Baseline|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477008|NCT00679783|B3|Baseline|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477009|NCT00679783|B2|Baseline|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
477010|NCT00679783|B1|Baseline|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
477011|NCT00679783|P7|Participant Flow|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
477012|NCT00679783|P6|Participant Flow|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
477013|NCT00679783|P5|Participant Flow|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
477015|NCT00679783|P3|Participant Flow|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477016|NCT00679783|P2|Participant Flow|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
477017|NCT00679783|P1|Participant Flow|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
477018|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
477019|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
477020|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
477021|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477022|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477023|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
477024|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
477451|NCT00680771|O1|Outcome|Primary Insomnia|patients meeting criteria for primary insomnia.
477026|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
477027|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
477028|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477029|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477030|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
477031|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
477032|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
477033|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
477034|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
477035|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477036|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477037|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
477038|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
477039|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
477040|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
477041|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
477042|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477043|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477044|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
477045|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
477046|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
477047|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
477048|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
477049|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477050|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477051|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
477052|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
477053|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
477054|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
477742|NCT00674115|E4|Reported Event|Zegerid (1-Day Dosing)|
477055|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
477056|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477057|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477058|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
477059|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
477060|NCT00679783|E7|Reported Event|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
477061|NCT00679783|E6|Reported Event|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
477062|NCT00679783|E5|Reported Event|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
477063|NCT00679783|E4|Reported Event|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477064|NCT00679783|E3|Reported Event|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
477065|NCT00679783|E2|Reported Event|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
477066|NCT00679783|E1|Reported Event|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
477067|NCT00679913|B3|Baseline|Total|Total of all reporting groups
477068|NCT00679913|B2|Baseline|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy
Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially."
477069|NCT00679913|B1|Baseline|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy
Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
477070|NCT00679913|P2|Participant Flow|Extended Pancreatoduodenectomy|extended pancreatoduodenectomy Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially.
477954|NCT00674700|B3|Baseline|Placebo|Placebo tablet
477071|NCT00679913|P1|Participant Flow|Standard Pancreatoduodenectomy|standard pancreatoduodenectomy Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)
477072|NCT00679913|O2|Outcome|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy
Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized"
477073|NCT00679913|O1|Outcome|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy
Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
477074|NCT00679913|O2|Outcome|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy
Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially."
477075|NCT00679913|O1|Outcome|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy
Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
477076|NCT00679913|E2|Reported Event|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy
Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized."
478706|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
477077|NCT00679913|E1|Reported Event|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy
Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
477078|NCT00679939|B3|Baseline|Total|Total of all reporting groups
477079|NCT00679939|B2|Baseline|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477080|NCT00679939|B1|Baseline|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477081|NCT00679939|P2|Participant Flow|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477082|NCT00679939|P1|Participant Flow|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477083|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477084|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477085|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477099|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477086|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477087|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477088|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477089|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477090|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477091|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477452|NCT00680771|E2|Reported Event|Good Sleepers|participants meetoing criteira for Good Sleepers
477092|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477093|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477094|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477095|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477096|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477097|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477098|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477226|NCT00679939|E4|Reported Event|Metformin: MET OL|At Week 52, all participants receiving MET in the DB Period were switched to open-label MET therapy for 24 weeks during the OL Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477100|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477101|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477102|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477103|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477104|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477105|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477106|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477107|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477108|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477109|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477110|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477111|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477112|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477113|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477114|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477115|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477116|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477117|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477118|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477119|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477120|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477121|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477122|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477123|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477124|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477125|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477126|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477127|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477128|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477129|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477130|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477131|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477132|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477133|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477134|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477135|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477136|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477137|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477138|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477139|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477140|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477141|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477142|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477143|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477144|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477145|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477146|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477147|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477148|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477149|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477150|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477151|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477152|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477153|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477154|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477155|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477156|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477157|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477158|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477159|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477160|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477161|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477162|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477163|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477164|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477165|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477166|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477167|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477168|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477169|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477170|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477171|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477172|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477173|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477174|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477175|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477176|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477177|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477178|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477179|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477180|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477181|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477182|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477183|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477184|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477185|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477186|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477187|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477188|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477189|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477190|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477191|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477192|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477193|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477194|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477195|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477196|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477197|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477198|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477199|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477200|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477201|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477202|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477203|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477204|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477205|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477206|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477207|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477208|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477209|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477210|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477211|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477212|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477213|NCT00679939|O2|Outcome|Metformin|Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477214|NCT00679939|O1|Outcome|Rosiglitazone|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477215|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477216|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477217|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477329|NCT00680316|B1|Baseline|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
477218|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477219|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477220|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477221|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477222|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477223|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477224|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477225|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477227|NCT00679939|E3|Reported Event|Rosiglitazone: MET OL|At Week 52, all participants receiving RSG in the DB Period were switched to open-label Metformin (MET) therapy for 24 weeks during the Open-label (OL) Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
477228|NCT00679939|E2|Reported Event|Metformin: DB|Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4 in the 52-week DB Period.
477229|NCT00679939|E1|Reported Event|Rosiglitazone: DB|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4 in the 52-week Double-Blind (DB) Period.
477230|NCT00679952|B3|Baseline|Total|Total of all reporting groups
477231|NCT00679952|B2|Baseline|Natural Drainage Group|natural drainage group (ND group)
477232|NCT00679952|B1|Baseline|Closed Suction Drainage Group|closed suction drainage group (CD group)
477233|NCT00679952|P2|Participant Flow|Natural Drainage Group|natural drainage group (ND group)
477234|NCT00679952|P1|Participant Flow|Closed Suction Drainage Group|closed suction drainage group (CD group)
477235|NCT00679952|O2|Outcome|Natural Drainage Group|natural drainage group (ND group)
477236|NCT00679952|O1|Outcome|Closed Suction Drainage Group|closed suction drainage group (CD group)
477237|NCT00679952|E2|Reported Event|Natural Drainage Group|natural drainage group (ND group)
477238|NCT00679952|E1|Reported Event|Closed Suction Drainage Group|closed suction drainage group (CD group)
477239|NCT00680017|B3|Baseline|Total|Total of all reporting groups
477240|NCT00680017|B2|Baseline|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
477241|NCT00680017|B1|Baseline|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
477242|NCT00680017|P2|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
477243|NCT00680017|P1|Participant Flow|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
477244|NCT00680017|O2|Outcome|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
477453|NCT00680771|E1|Reported Event|Primary Insomnia|patients meeting criteria for primary insomnia.
477245|NCT00680017|O1|Outcome|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
477246|NCT00680017|O2|Outcome|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
477247|NCT00680017|O1|Outcome|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
477248|NCT00680017|E2|Reported Event|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
477249|NCT00680017|E1|Reported Event|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
477250|NCT00680043|B4|Baseline|Total|Total of all reporting groups
477251|NCT00680043|B3|Baseline|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477252|NCT00680043|B2|Baseline|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477253|NCT00680043|B1|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
477254|NCT00680043|P3|Participant Flow|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477255|NCT00680043|P2|Participant Flow|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477256|NCT00680043|P1|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
477257|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477258|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477259|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
477260|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477261|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477262|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
477263|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477264|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477265|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
477266|NCT00680043|E3|Reported Event|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477267|NCT00680043|E2|Reported Event|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
477268|NCT00680043|E1|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
477269|NCT00680056|B3|Baseline|Total|Total of all reporting groups
477270|NCT00680056|B2|Baseline|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
477271|NCT00680056|B1|Baseline|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
477272|NCT00680056|P2|Participant Flow|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
477273|NCT00680056|P1|Participant Flow|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
477274|NCT00680056|O2|Outcome|Formoterol Plus Tiotropium Treatment|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
477275|NCT00680056|O1|Outcome|Formoterol Plus Placebo (Tiotropium) Treatment|Formoterol + Placebo (Tiotropium) in either first intervention period or second intervention period.
477276|NCT00680056|O2|Outcome|Formoterol Plus Tiotropium Treatment|Formoterol + Tiotropium in either first intervention period or second intervention period.
477277|NCT00680056|O1|Outcome|Formoterol Plus Placebo (Tiotropium) Treatment|Formoterol + Placebo (Tiotropium) in either first intervention period or second intervention period.
477278|NCT00680056|E2|Reported Event|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
477279|NCT00680056|E1|Reported Event|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
477280|NCT00680121|B3|Baseline|Total|Total of all reporting groups
477281|NCT00680121|B2|Baseline|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
477282|NCT00680121|B1|Baseline|Control Group|Placebo; identically matched to Benfotiamine capsules
477283|NCT00680121|P2|Participant Flow|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
477284|NCT00680121|P1|Participant Flow|Control Group|Placebo; identically matched to Benfotiamine capsules
477285|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
477286|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
477287|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
477288|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
477289|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
477290|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
477291|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
477292|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
477293|NCT00680121|E2|Reported Event|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
477294|NCT00680121|E1|Reported Event|Control Group|Placebo; identically matched to Benfotiamine capsules
477295|NCT00680186|B3|Baseline|Total|Total of all reporting groups
477296|NCT00680186|B2|Baseline|Warfarin|PRN to maintain an INR of 2.0-3.0
477297|NCT00680186|B1|Baseline|Dabigatran 150 mg|bid oral
477298|NCT00680186|P2|Participant Flow|Warfarin|PRN (as needed) to maintain an INR (international normalised ratio) of 2.0-3.0
477299|NCT00680186|P1|Participant Flow|Dabigatran 150 mg|bid (twice daily) oral
477300|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
477301|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
477302|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
477303|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
477304|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
477305|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
477306|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
477307|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
477308|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
477309|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
477310|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
477311|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
477312|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
477313|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
477314|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
477315|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
477316|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
477317|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
477322|NCT00680225|B1|Baseline|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
477323|NCT00680225|P1|Participant Flow|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
477324|NCT00680225|O1|Outcome|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
477325|NCT00680225|O1|Outcome|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
477326|NCT00680225|E1|Reported Event|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
477327|NCT00680316|B3|Baseline|Total|Total of all reporting groups
477328|NCT00680316|B2|Baseline|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
477331|NCT00680316|P1|Participant Flow|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
477332|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
477333|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
477334|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
477335|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
477336|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
477337|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
477338|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
477339|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
477340|NCT00680316|E2|Reported Event|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
477341|NCT00680316|E1|Reported Event|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
477342|NCT00680368|B1|Baseline|Physician Residents and Attending Physicians|includes physician residents and attending physicians who were asked to sit through a face to face interview with a research assistant following a clinical encounter with a patient
477343|NCT00680368|P1|Participant Flow|Group 1|The study began with 112 responders: 75 physician residents and 37 attending physicians. Only 60 of the 75 residents had been supervised by one of the 37 participating attending physicians. Thus, 15 residents were dropped from study. Both resident and their attending physician were surveyed to report total supervision time for each of 148 clinical encounters with 143 patients. There were more clinical encounters than patients because some patients had more than one encounter. There were more physician residents than attending physicians because attending physicians may have supervised more than one resident. There were more clinical encounters than residents because a resident may be involved in more than one clinical encounter with a patient.
477344|NCT00680368|O1|Outcome|Attending Physicians|Results reported only for the 37 attending physicians in the study sample
477345|NCT00680368|O1|Outcome|Physician Residents|Includes physician residents who had a supervising attending physician participating in the study, and who received a face to face interview with a research assistant
477346|NCT00680368|O1|Outcome|Physician Residents and Attending Physicians|Sample included 112, including 60 physician residents and 37 attending physicians
477347|NCT00680368|E1|Reported Event|Group 1|Sample included 75 resident physicians. No adverse events noted.
477348|NCT00680407|B4|Baseline|Total|Total of all reporting groups
477349|NCT00680407|B3|Baseline|Placebo|"Placebo (lactose pill)
Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
477350|NCT00680407|B2|Baseline|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily
Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477351|NCT00680407|B1|Baseline|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily
Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477352|NCT00680407|P3|Participant Flow|Placebo|"Placebo (lactose pill)
Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
477353|NCT00680407|P2|Participant Flow|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily
Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477354|NCT00680407|P1|Participant Flow|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily
Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477355|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)
Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
477356|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily
Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477357|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily
Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477955|NCT00674700|B2|Baseline|500 IR|500 IR house dust mites allergen extract tablet
477359|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily
Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477360|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily
Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477361|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)
Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
477362|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily
Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477363|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily
Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477364|NCT00680407|E3|Reported Event|Placebo|"Placebo (lactose pill)
Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
477365|NCT00680407|E2|Reported Event|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily
Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477366|NCT00680407|E1|Reported Event|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily
Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
477367|NCT00680459|B3|Baseline|Total|Total of all reporting groups
477368|NCT00680459|B2|Baseline|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477369|NCT00680459|B1|Baseline|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477454|NCT00680797|B5|Baseline|Total|Total of all reporting groups
477370|NCT00680459|P2|Participant Flow|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477371|NCT00680459|P1|Participant Flow|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477372|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477373|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477374|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477375|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477376|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477377|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477378|NCT00680459|E2|Reported Event|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477379|NCT00680459|E1|Reported Event|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
477380|NCT00680524|B1|Baseline|Arm 1|"Open pilot trial
Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
477381|NCT00680524|P1|Participant Flow|Arm 1|"Open pilot trial
Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
477382|NCT00680524|O1|Outcome|Arm 1|"Open pilot trial
Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
477383|NCT00680524|E1|Reported Event|Arm 1|"Open pilot trial
Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
477384|NCT00680628|B3|Baseline|Total|Total of all reporting groups
477385|NCT00680628|B2|Baseline|Tenecteplase|"Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
477430|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
477431|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
478754|NCT00683657|E1|Reported Event|PLACEBO + MET|
477386|NCT00680628|B1|Baseline|Placebo|"Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
477387|NCT00680628|P2|Participant Flow|Tenecteplase|"Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
477388|NCT00680628|P1|Participant Flow|Placebo|"Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
477389|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
477390|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
477391|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
477392|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
477393|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
477455|NCT00680797|B4|Baseline|-T -E|-Testosterone, -Estrogen
477456|NCT00680797|B3|Baseline|-T +E|"-Testosterone, +Estrogen
Estrogen: Estrogen patch"
477394|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
477395|NCT00680628|E2|Reported Event|Tenecteplase|"Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
477396|NCT00680628|E1|Reported Event|Placebo|"Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
477397|NCT00680706|B3|Baseline|Total|Total of all reporting groups
477398|NCT00680706|B2|Baseline|Control|Receives placebo
477399|NCT00680706|B1|Baseline|Thiamine|Receives thiamine
477400|NCT00680706|P2|Participant Flow|Control|Receives placebo
477401|NCT00680706|P1|Participant Flow|Thiamine|Receives thiamine, 100 mg intravenously at baseline (time 0-hour) and again at time 24-hour.
477402|NCT00680706|O2|Outcome|Thiamine|
477403|NCT00680706|O1|Outcome|Control|Placebo
477404|NCT00680706|O2|Outcome|Thiamine|
477405|NCT00680706|O1|Outcome|Control|Placebo
477406|NCT00680706|E2|Reported Event|Control|Receives placebo
477407|NCT00680706|E1|Reported Event|Thiamine|Receives thiamine
477408|NCT00680745|B5|Baseline|Total|Total of all reporting groups
477409|NCT00680745|B4|Baseline|Placebo + Glimepiride|Placebo comparator plus glimepiride
477410|NCT00680745|B3|Baseline|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
477411|NCT00680745|B2|Baseline|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
477412|NCT00680745|B1|Baseline|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
477413|NCT00680745|P4|Participant Flow|Placebo + Glimepiride|Placebo comparator plus glimepiride
477414|NCT00680745|P3|Participant Flow|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
477415|NCT00680745|P2|Participant Flow|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
477416|NCT00680745|P1|Participant Flow|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
477417|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
477418|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
477419|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
477420|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
477421|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
477422|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
477423|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
477424|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
477425|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
477426|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
477427|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
477428|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
477429|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
477432|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
477433|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
477434|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
477435|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
477436|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
477437|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
477438|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
477439|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
477440|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
477441|NCT00680745|E4|Reported Event|Placebo + Glimepiride|Placebo comparator plus glimepiride
477442|NCT00680745|E3|Reported Event|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
477443|NCT00680745|E2|Reported Event|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
477444|NCT00680745|E1|Reported Event|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
477445|NCT00680771|B3|Baseline|Total|Total of all reporting groups
477446|NCT00680771|B2|Baseline|Good Sleepers|participants meetoing criteira for Good Sleepers
477447|NCT00680771|B1|Baseline|Primary Insomnia|patients meeting criteria for primary insomnia.
477448|NCT00680771|P2|Participant Flow|Good Sleepers|Subjects meeting criteira for Good Sleepers
477449|NCT00680771|P1|Participant Flow|Primary Insomnia|Subjects meeting criteria for primary insomnia.
477450|NCT00680771|O2|Outcome|Good Sleepers|participants meetoing criteira for Good Sleepers
477458|NCT00680797|B1|Baseline|+T +E|"+Testosterone, +Estrogen
Testosterone: Testosterone gel
Estrogen: Estrogen patch"
477459|NCT00680797|P4|Participant Flow|-T -E|-Testosterone, -Estrogen
477460|NCT00680797|P3|Participant Flow|-T +E|"-Testosterone, +Estrogen
Estrogen: Estrogen patch"
477461|NCT00680797|P2|Participant Flow|+T -E|"+Testosterone, -Estrogen
Testosterone: Testosterone gel"
477462|NCT00680797|P1|Participant Flow|+T +E|"+Testosterone, +Estrogen
Testosterone: Testosterone gel
Estrogen: Estrogen patch"
477463|NCT00680797|O4|Outcome|-T -E|-Testosterone, -Estrogen
477464|NCT00680797|O3|Outcome|-T +E|"-Testosterone, +Estrogen
Estrogen: Estrogen patch"
477465|NCT00680797|O2|Outcome|+T -E|"+Testosterone, -Estrogen
Testosterone: Testosterone gel"
477466|NCT00680797|O1|Outcome|+T +E|"+Testosterone, +Estrogen
Testosterone: Testosterone gel
Estrogen: Estrogen patch"
477467|NCT00680797|E4|Reported Event|-T -E|-Testosterone, -Estrogen
477468|NCT00680797|E3|Reported Event|-T +E|"-Testosterone, +Estrogen
Estrogen: Estrogen patch"
477469|NCT00680797|E2|Reported Event|+T -E|"+Testosterone, -Estrogen
Testosterone: Testosterone gel"
477470|NCT00680797|E1|Reported Event|+T +E|"+Testosterone, +Estrogen
Testosterone: Testosterone gel
Estrogen: Estrogen patch"
477471|NCT00680836|B3|Baseline|Total|Total of all reporting groups
477472|NCT00680836|B2|Baseline|Treatment|These patients have Irritable Bowel syndrome (IBS) and are receiving the rifaximin 550mg twice a day
477473|NCT00680836|B1|Baseline|Placebo|These patients have Irritable Bowel syndrome (IBS) and are receiving the placebo twice a day
477474|NCT00680836|P2|Participant Flow|Active Group|These patients have Irritable Bowel syndrome and are receiving rifaximin 550mg twice a day
477475|NCT00680836|P1|Participant Flow|Placebo Group|These patients have Irritable Bowel syndrome and are receiving the placebo twice a day
477476|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
477477|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
477478|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
477479|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
477480|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
477481|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
477482|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
477483|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
477484|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
477485|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
477486|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
477487|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving placebo tablets twice a day
477488|NCT00680836|E2|Reported Event|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
477489|NCT00680836|E1|Reported Event|Placebo Group|These patients have IBS and are receiving placebo tablets twice a day
477490|NCT00680862|B1|Baseline|Group 1|VA employees
477491|NCT00680862|P1|Participant Flow|Group 1|VA employees
477492|NCT00680862|O1|Outcome|Group 1|VA employees
477493|NCT00680862|E1|Reported Event|Group 1|VA employees
477494|NCT00680901|B3|Baseline|Total|Total of all reporting groups
477575|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477576|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477577|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
477495|NCT00680901|B2|Baseline|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477496|NCT00680901|B1|Baseline|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477497|NCT00680901|P2|Participant Flow|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477538|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477539|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477540|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477498|NCT00680901|P1|Participant Flow|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477499|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477500|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477501|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477502|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477578|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477503|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477504|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477505|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477541|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477542|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477543|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477544|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
478707|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
477506|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477507|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477508|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477509|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477510|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477511|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477512|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477513|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477545|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477546|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477547|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477548|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
478689|NCT00683618|P3|Participant Flow|Atorvastatin 10mg|Taken orally once daily
477514|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477515|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477516|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477517|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477518|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477519|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477520|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477521|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477549|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477550|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477551|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477552|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
478690|NCT00683618|P2|Participant Flow|Rosuvastatin 10mg|Taken orally once daily
477522|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477523|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477524|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477525|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477526|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477527|NCT00680901|E2|Reported Event|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
477528|NCT00680901|E1|Reported Event|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
477529|NCT00680914|B3|Baseline|Total|Total of all reporting groups
477530|NCT00680914|B2|Baseline|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477531|NCT00680914|B1|Baseline|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477532|NCT00680914|P2|Participant Flow|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477533|NCT00680914|P1|Participant Flow|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477534|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477535|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477536|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477537|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477620|NCT00681187|O1|Outcome|Baseline|Baseline refers to the last non-study visit at the clinic.
477553|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477554|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477555|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477556|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477557|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477558|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477559|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477560|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477561|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477562|NCT00680914|E2|Reported Event|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477563|NCT00680914|E1|Reported Event|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
477564|NCT00680953|B4|Baseline|Total|Total of all reporting groups
477565|NCT00680953|B3|Baseline|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
477566|NCT00680953|B2|Baseline|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477567|NCT00680953|B1|Baseline|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477568|NCT00680953|P3|Participant Flow|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
477569|NCT00680953|P2|Participant Flow|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477570|NCT00680953|P1|Participant Flow|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477571|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
477572|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477573|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477574|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
477956|NCT00674700|B1|Baseline|300 IR|300 IR house dust mites allergen extract tablet
477579|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477580|NCT00680953|E3|Reported Event|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
477581|NCT00680953|E2|Reported Event|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477582|NCT00680953|E1|Reported Event|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
477583|NCT00681044|B1|Baseline|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2
Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
477584|NCT00681044|P1|Participant Flow|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection (SCC) Melphalan Conditioning Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2
Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
477585|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2
Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
477586|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2
Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
477587|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2
Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
477588|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2
Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
477589|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2
Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
477590|NCT00681044|E1|Reported Event|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2
Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
477591|NCT00681109|B4|Baseline|Total|Total of all reporting groups
477592|NCT00681109|B3|Baseline|5% IL-1Ra|Anakinra 5% Topical Ophthalmic Solution
477593|NCT00681109|B2|Baseline|Placebo|Artificial Tear Topical Ophthalmic Solution
477594|NCT00681109|B1|Baseline|2.5% IL-1Ra|Anakinra 2.5% Topical Ophthalmic Solution
477595|NCT00681109|P3|Participant Flow|5% IL-1Ra|Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
477596|NCT00681109|P2|Participant Flow|Placebo|Artificial Tear Topical Ophthalmic Solution three times per day.
477597|NCT00681109|P1|Participant Flow|2.5% IL-1Ra|Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.
477598|NCT00681109|O3|Outcome|Anakinra 5% Topical Ophthalmic Solution|The OSDI was assessed for patients taking Anakinra (KINERET) 5%. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
477599|NCT00681109|O2|Outcome|Artificial Tear Topical Ophthalmic Solution|The OSDI was assessed for patients taking placebo. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
477600|NCT00681109|O1|Outcome|Anakinra 2.5% Topical Ophthalmic Solution|In this study, the OSDI was assessed for patients taking Anakinra (KINERET) 2.5%. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
477601|NCT00681109|E3|Reported Event|5% IL-1Ra|Anakinra 5% Topical Ophthalmic Solution
477602|NCT00681109|E2|Reported Event|Placebo|Artificial Tear Topical Ophthalmic Solution
477603|NCT00681109|E1|Reported Event|2.5% IL-1Ra|Anakinra 2.5% Topical Ophthalmic Solution
477604|NCT00681187|B3|Baseline|Total|Total of all reporting groups
477605|NCT00681187|B2|Baseline|Group 2 HCP Then Self or Partner Administration|Administration by HCP then self or partner administration.
477606|NCT00681187|B1|Baseline|Group 1 Self or Partner First Then HCP Administration|Self or partner administration followed by HCP administration.
477607|NCT00681187|P2|Participant Flow|Group 2 HCP Then Self or Partner Administration|Started with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the subject or partner under supervision at the healthcare provider facilities. A self-administration block followed the training injections with 3 subsequent unsupervised injections every 28th day at the subject’s home. The subject visited the clinic for a follow-up visit 14 days after the last self-partner administered injection.
477640|NCT00681265|P1|Participant Flow|Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
477608|NCT00681187|P1|Participant Flow|Group 1 Self or Partner First Then HCP Administration|Started with a training period where the subject or partner performed two or three training injections under supervision of a Healthcare Professional (HCP) at a healthcare provider facility. The training injections were followed by a self administration block of three subsequent unsupervised injections every 28th day at the subject’s home. A healthcare administration block followed the self administration block with three HCP provided injections according to clinical routine every 28th day.
477609|NCT00681187|O1|Outcome|Overall Study Group|One HCP from each site who enrolled participants answered the questions
477610|NCT00681187|O4|Outcome|After HCP Administration|After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
477611|NCT00681187|O3|Outcome|Before HCP Administration|Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
477612|NCT00681187|O2|Outcome|After Self or Partner Administration|After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.
477613|NCT00681187|O1|Outcome|Before Self or Partner Administration|Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.
477614|NCT00681187|O4|Outcome|After HCP Administration|After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
477615|NCT00681187|O3|Outcome|Before HCP Administration|Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
477616|NCT00681187|O2|Outcome|After Self or Partner Administration|After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.
477617|NCT00681187|O1|Outcome|Before Self or Partner Administration|Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.
477618|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
477619|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
477621|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
477622|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
477623|NCT00681187|O1|Outcome|Baseline|Baseline refers to the last non-study visit at the clinic.
477624|NCT00681187|O2|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
477625|NCT00681187|O1|Outcome|Self or Partner Administration|The self or partner administration block (after the training) included three unsupervised injections every 28th day at the subject's home.
477626|NCT00681187|O2|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
477627|NCT00681187|O1|Outcome|Self or Partner Administration|The self or partner administration block (after the training period) included three unsupervised injections every 28th day at the subject's home.
477628|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
477629|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
477630|NCT00681187|O1|Outcome|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
477631|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
477632|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
477633|NCT00681187|O1|Outcome|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
477634|NCT00681187|O2|Outcome|Group 2 HCP Then Self or Partner Administration|Administration by HCP then Self or Partner Administration.
477635|NCT00681187|O1|Outcome|Group 1 Self or Partner First Then HCP Administration|Self or Partner Administration followed by HCP Administration.
477636|NCT00681187|E3|Reported Event|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
477637|NCT00681187|E2|Reported Event|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
477638|NCT00681187|E1|Reported Event|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
477639|NCT00681265|B1|Baseline|Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
477641|NCT00681265|O2|Outcome|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
477642|NCT00681265|O1|Outcome|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
477643|NCT00681265|O2|Outcome|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
477644|NCT00681265|O1|Outcome|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
477645|NCT00681265|E2|Reported Event|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
477646|NCT00681265|E1|Reported Event|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
477647|NCT00681291|B3|Baseline|Total|Total of all reporting groups
477648|NCT00681291|B2|Baseline|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
477649|NCT00681291|B1|Baseline|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
477650|NCT00681291|P2|Participant Flow|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
477651|NCT00681291|P1|Participant Flow|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
477652|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
477653|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
477654|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
477655|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
477657|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
477658|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
477659|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
477660|NCT00681291|E2|Reported Event|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
477661|NCT00681291|E1|Reported Event|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
477662|NCT00673712|B3|Baseline|Total|Total of all reporting groups
477663|NCT00673712|B2|Baseline|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics
Opioid based analgesia: Opioid Analgesic agents delivered by:
PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
477664|NCT00673712|B1|Baseline|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
477665|NCT00673712|P2|Participant Flow|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics
Opioid based analgesia: Opioid Analgesic agents delivered by:
PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
477666|NCT00673712|P1|Participant Flow|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
477667|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics
Opioid based analgesia: Opioid Analgesic agents delivered by:
PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
477668|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
477669|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics
Opioid based analgesia: Opioid Analgesic agents delivered by:
PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
477670|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
477671|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics
Opioid based analgesia: Opioid Analgesic agents delivered by:
PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
477672|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
477673|NCT00673712|E2|Reported Event|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics
Opioid based analgesia: Opioid Analgesic agents delivered by:
PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
477674|NCT00673712|E1|Reported Event|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
477675|NCT00673738|B1|Baseline|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
477676|NCT00673738|P1|Participant Flow|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
477677|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
477725|NCT00673933|E2|Reported Event|Vehicle Cream With PDT|"PDT using Placebo cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477957|NCT00674700|P3|Participant Flow|Placebo|Placebo tablet
477678|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
477679|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
477680|NCT00673738|E1|Reported Event|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
477681|NCT00673764|B1|Baseline|Overall Study|Overall Study
477682|NCT00673764|P2|Participant Flow|Optive, Then Systane Ultra|Optive Lubricant Eye Drops first, then cross-over to Systane Ultra.
477683|NCT00673764|P1|Participant Flow|Systane Ultra, Then Optive|Systane Ultra Lubricant Eye Drops first, then cross-over to Optive.
477684|NCT00673764|O2|Outcome|Optive|Optive Lubricant Eye Drops
477685|NCT00673764|O1|Outcome|Systane Ultra|Systane Ultra Lubricant Eye Drops.
477686|NCT00673764|O2|Outcome|Optive|Optive Lubricant Eye Drops
477687|NCT00673764|O1|Outcome|Systane Ultra|Systane Ultra Lubricant Eye Drops.
477688|NCT00673764|E2|Reported Event|Optive|Optive Lubricant Eye Drops
477689|NCT00673764|E1|Reported Event|Systane Ultra|Systane Ultra Lubricant Eye Drops.
477690|NCT00673816|B1|Baseline|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period).
477691|NCT00673816|P1|Participant Flow|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
477692|NCT00673816|O2|Outcome|Right Eye|
477693|NCT00673816|O1|Outcome|Left Eye|
477694|NCT00673816|O2|Outcome|Right Eye|
477695|NCT00673816|O1|Outcome|Left Eye|
477917|NCT00674609|E2|Reported Event|THC Alone|Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC
477696|NCT00673816|E1|Reported Event|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
477697|NCT00673855|B1|Baseline|Overall Study|
477698|NCT00673855|P2|Participant Flow|Optive Drops, Then Lubricant Drops|Patients received Optive Drops first, then received Lubricant Drops
477699|NCT00673855|P1|Participant Flow|Lubricant Drops, Then Optive Drops|Patients received lubricant Drops first, then received Optive Drops
477700|NCT00673855|O2|Outcome|Lubricant Eye Drops|Lubricant Eye Drops
477701|NCT00673855|O1|Outcome|Lubricant Eye Drops FID 112903|Lubricant Eye Drops FID 112903
477702|NCT00673855|E2|Reported Event|Lubricant Eye Drops|Lubricant Eye Drops
477703|NCT00673855|E1|Reported Event|Lubricant Eye Drops FID 112903|Lubricant Eye Drops FID 112903
477704|NCT00673881|B1|Baseline|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
477705|NCT00673881|P1|Participant Flow|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
477706|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
477707|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
477708|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
477709|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
477710|NCT00673881|E1|Reported Event|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
477711|NCT00673933|B1|Baseline|Visonac and Vehicle Cream With PDT|Two areas on the back per patient was treated, one area with Visonac (Methyl aminolevulinate) and one with vehicle followed by red light illumination.
477712|NCT00673933|P1|Participant Flow|Visonac Cream With PDT and Vehicle and PDT|Two areas on the back per patient was treated, one area with Visonac and one with vehicle. Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
477713|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477714|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477715|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477716|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477717|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477718|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477719|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477720|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477721|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477722|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477723|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477724|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477958|NCT00674700|P2|Participant Flow|500 IR|500 IR house dust mites allergen extract tablet
477726|NCT00673933|E1|Reported Event|Visonac Cream With PDT|"PDT using MAL cream
Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
477727|NCT00673959|B1|Baseline|Overall Study|
477728|NCT00673959|P2|Participant Flow|Optive Drops, Then Lubricant Drops|Patients received Optive Drops first, then received Lubricant Drops
477729|NCT00673959|P1|Participant Flow|Lubricant Drops, Then Optive Drops|Patients received Lubricant Drops first, then received Optive Drops
477730|NCT00673959|O2|Outcome|Optive Lubricant Eye Drop|
477731|NCT00673959|O1|Outcome|Lubricant Eye Drop FID 111421|
477732|NCT00673959|E2|Reported Event|Optive Lubricant Eye Drop|
477733|NCT00673959|E1|Reported Event|Lubricant Eye Drop FID 111421|
477734|NCT00674115|B1|Baseline|Entire Study Population|
477735|NCT00674115|P4|Participant Flow|Prilosec, Zegerid|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period)
477736|NCT00674115|P3|Participant Flow|Zegerid, Prilosec|Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
477737|NCT00674115|P2|Participant Flow|Prilosec, Zegerid, Sodium Bicarbonate|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention, Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
477738|NCT00674115|P1|Participant Flow|Zegerid, Prilosec, Sodium Bicarbonate|Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention, Prilosec over-the-counter (OTC) Tablets (omeprazole 20 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
477739|NCT00674115|O2|Outcome|Prilosec|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
477740|NCT00674115|O1|Outcome|Zegerid|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
477743|NCT00674115|E3|Reported Event|Sodium Bicarbonate (1-Day Dosing)|Following completion of the 1-day dosing 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate 1680 mg.
477744|NCT00674115|E2|Reported Event|Prilosec (7-Day Dosing)|
477745|NCT00674115|E1|Reported Event|Zegerid (7-Day Dosing)|
477746|NCT00674128|B3|Baseline|Total|Total of all reporting groups
477747|NCT00674128|B2|Baseline|Suture|Polyglactin 910 suture.
477748|NCT00674128|B1|Baseline|Adhesive|Cyanoacrylate tissue adhesive.
477749|NCT00674128|P2|Participant Flow|Suture|Polyglactin 910 suture.
477750|NCT00674128|P1|Participant Flow|Adhesive|Cyanoacrylate tissue adhesive.
477751|NCT00674128|O2|Outcome|Suture|Polyglactin 910 suture.
477752|NCT00674128|O1|Outcome|Adhesive|Cyanoacrylate tissue adhesive.
477753|NCT00674128|E2|Reported Event|Suture|Polyglactin 910 suture
477754|NCT00674128|E1|Reported Event|Adhesive|Cyanoacrylate tissue adhesive.
477755|NCT00674154|B3|Baseline|Total|Total of all reporting groups
477756|NCT00674154|B2|Baseline|Placebo|Placebo, two tablets daily in 52 weeks.
477757|NCT00674154|B1|Baseline|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
477758|NCT00674154|P2|Participant Flow|Placebo|Placebo, two tablets daily in 52 weeks.
477759|NCT00674154|P1|Participant Flow|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
477760|NCT00674154|O2|Outcome|Placebo|Placebo, two tablets daily in 52 weeks.
477761|NCT00674154|O1|Outcome|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
477762|NCT00674154|E2|Reported Event|Placebo|Placebo, two tablets daily in 52 weeks.
477763|NCT00674154|E1|Reported Event|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
477764|NCT00674206|B1|Baseline|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
477765|NCT00674206|P1|Participant Flow|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
477766|NCT00674206|O1|Outcome|Gemcitabine and Oxaliplatin|All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
477767|NCT00674206|O1|Outcome|Gemcitabine and Oxaliplatin|All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
477768|NCT00674206|E1|Reported Event|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
477769|NCT00674323|B4|Baseline|Total|Total of all reporting groups
477770|NCT00674323|B3|Baseline|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477771|NCT00674323|B2|Baseline|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477798|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477772|NCT00674323|B1|Baseline|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477773|NCT00674323|P3|Participant Flow|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477774|NCT00674323|P2|Participant Flow|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477775|NCT00674323|P1|Participant Flow|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477813|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477776|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477777|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477778|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477779|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477780|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477781|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477799|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477800|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477782|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477783|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477784|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477785|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477786|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477787|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
477788|NCT00674323|E3|Reported Event|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
477789|NCT00674323|E2|Reported Event|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
477790|NCT00674323|E1|Reported Event|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
477791|NCT00674362|B3|Baseline|Total|Total of all reporting groups
477792|NCT00674362|B2|Baseline|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477793|NCT00674362|B1|Baseline|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477794|NCT00674362|P2|Participant Flow|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477795|NCT00674362|P1|Participant Flow|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477796|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477797|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477801|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477802|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477803|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477804|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477805|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477806|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477807|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477808|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477809|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477810|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477811|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477812|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477814|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477815|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477816|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477817|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477818|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477819|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477820|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477821|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477822|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477823|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477824|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477825|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477826|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477827|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477828|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477829|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477830|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477831|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477832|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477833|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477834|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
478755|NCT00683696|B3|Baseline|Total|Total of all reporting groups
477835|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477836|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477837|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477838|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477839|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477840|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477841|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477842|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477843|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477844|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477845|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477846|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
478708|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
477847|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477848|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477849|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477850|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477851|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477852|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477853|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477854|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477855|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477856|NCT00674362|E3|Reported Event|Open Label Phase|At Week 24 subjects are evaluated. Non-remitters are discontinued from the study with the opportunity to enter another open label (OL) study. Remitters stop randomized treatment and are followed up until Week 52. Remitters who flare up between Week 24 and Week 52 will be re-treated with (3 administrations of 400 mg CZP, given every other week, followed by 200 mg CZP given every other week) up to and including Week 50. Of the 27 subjects in the OL phase 15 were retreated and 12 were not retreated.
477857|NCT00674362|E2|Reported Event|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
477858|NCT00674362|E1|Reported Event|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
477859|NCT00674466|B4|Baseline|Total|Total of all reporting groups
477860|NCT00674466|B3|Baseline|Placebo|"Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week"
477861|NCT00674466|B2|Baseline|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo
1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
477862|NCT00674466|B1|Baseline|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week"
477863|NCT00674466|P3|Participant Flow|Placebo|"Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week"
477864|NCT00674466|P2|Participant Flow|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo
1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
477865|NCT00674466|P1|Participant Flow|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week"
477866|NCT00674466|O3|Outcome|Placebo|"Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week"
477867|NCT00674466|O2|Outcome|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo
1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
477868|NCT00674466|O1|Outcome|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week"
479290|NCT00684307|E3|Reported Event|AZD0837 450 mg od|
477870|NCT00674466|O2|Outcome|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo
1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
477871|NCT00674466|O1|Outcome|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week"
477872|NCT00674466|O3|Outcome|Placebo|"Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week"
477873|NCT00674466|O2|Outcome|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo
1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
477874|NCT00674466|O1|Outcome|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week"
477875|NCT00674466|E3|Reported Event|Placebo|"Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week"
477876|NCT00674466|E2|Reported Event|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo
1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
477877|NCT00674466|E1|Reported Event|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week"
477878|NCT00674492|B1|Baseline|Group 1|patients who initiated antiviral treatment for hepatitis C
477879|NCT00674492|P1|Participant Flow|Group 1|patients who initiated antiviral treatment for hepatitis C
477880|NCT00674492|O1|Outcome|Group 1|patients who initiated antiviral treatment for hepatitis C
477881|NCT00674492|E1|Reported Event|Group 1|patients who initiated antiviral treatment for hepatitis C
477882|NCT00674609|B4|Baseline|Total|Total of all reporting groups
477883|NCT00674609|B3|Baseline|Placebo|Each 100 uL actuation contained colourant and excipients
477884|NCT00674609|B2|Baseline|THC Alone|Each 100 uL actuation contained 27 mg/ml THC
477885|NCT00674609|B1|Baseline|Sativex|Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
477886|NCT00674609|P3|Participant Flow|Placebo|Each 100 uL actuation contained colourant and excipients
477887|NCT00674609|P2|Participant Flow|THC Alone|Each 100 uL actuation contained 27 mg/ml THC
477888|NCT00674609|P1|Participant Flow|Sativex|Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
477979|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
477889|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
477890|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
477891|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
477892|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
477893|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
477894|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
477895|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
477896|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
477897|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
477898|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
477899|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
477900|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
477901|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
477902|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
477903|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
477904|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
477905|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
477959|NCT00674700|P1|Participant Flow|300 IR|300 IR house dust mites allergen extract tablet
477906|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
477907|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
477908|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
477909|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
477910|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
477911|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
477912|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
477913|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
477914|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
477915|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
477916|NCT00674609|E3|Reported Event|Placebo|Maximum number of daily sprays was 48
477918|NCT00674609|E1|Reported Event|Sativex|Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC and 120 mg CBD
477919|NCT00674622|B4|Baseline|Total|Total of all reporting groups
477920|NCT00674622|B3|Baseline|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
477921|NCT00674622|B2|Baseline|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
477922|NCT00674622|B1|Baseline|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
477923|NCT00674622|P3|Participant Flow|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
477924|NCT00674622|P2|Participant Flow|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
477925|NCT00674622|P1|Participant Flow|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
477926|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
477927|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
477928|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
477929|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
477930|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
477931|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
477932|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
477933|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
477934|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
477935|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
477936|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
477937|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
477938|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
477939|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
477940|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
477941|NCT00674622|E3|Reported Event|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
477942|NCT00674622|E2|Reported Event|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
477943|NCT00674622|E1|Reported Event|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
477944|NCT00674661|B3|Baseline|Total|Total of all reporting groups
477945|NCT00674661|B2|Baseline|Control Group|riboflavin opthalmic solution without UVA irradiation
477946|NCT00674661|B1|Baseline|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
477947|NCT00674661|P2|Participant Flow|Control Group|riboflavin opthalmic solution without UVA irradiation
477948|NCT00674661|P1|Participant Flow|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
477949|NCT00674661|O2|Outcome|Control Group|riboflavin opthalmic solution without UVA irradiation
477950|NCT00674661|O1|Outcome|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
477951|NCT00674661|E2|Reported Event|Control Group|riboflavin opthalmic solution without UVA irradiation
477952|NCT00674661|E1|Reported Event|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
477953|NCT00674700|B4|Baseline|Total|Total of all reporting groups
477961|NCT00674700|O2|Outcome|500 IR|500 IR house dust mites allergen extract tablet
477962|NCT00674700|O1|Outcome|300 IR|300 IR house dust mites allergen extract tablet
477963|NCT00674700|O3|Outcome|Placebo|Placebo tablet
477964|NCT00674700|O2|Outcome|500 IR|500 IR house dust mites allergen extract tablet
477965|NCT00674700|O1|Outcome|300 IR|300 IR house dust mites allergen extract tablet
477966|NCT00674700|E3|Reported Event|Placebo|Placebo tablet
477967|NCT00674700|E2|Reported Event|500 IR|500 IR house dust mites allergen extract tablet
477968|NCT00674700|E1|Reported Event|300 IR|300 IR house dust mites allergen extract tablet
477969|NCT00674739|B4|Baseline|Total|Total of all reporting groups
477970|NCT00674739|B3|Baseline|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
477971|NCT00674739|B2|Baseline|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
477972|NCT00674739|B1|Baseline|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
477973|NCT00674739|P3|Participant Flow|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
477974|NCT00674739|P2|Participant Flow|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
477975|NCT00674739|P1|Participant Flow|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
477976|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
477977|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
477978|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
478709|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
477980|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
477981|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
477982|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
477983|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
477984|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
477985|NCT00674739|E3|Reported Event|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
477986|NCT00674739|E2|Reported Event|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
477987|NCT00674739|E1|Reported Event|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
477988|NCT00674765|B3|Baseline|Total|Total of all reporting groups
477989|NCT00674765|B2|Baseline|Placebo|"Placebo
Placebo: 400 mg/day"
477990|NCT00674765|B1|Baseline|Seroquel|"Seroquel
Seroquel: 400 mg/day"
477991|NCT00674765|P2|Participant Flow|Placebo|"Placebo
Placebo: 400 mg/day"
477992|NCT00674765|P1|Participant Flow|Seroquel|"Seroquel
Seroquel: 400 mg/day"
477993|NCT00674765|O2|Outcome|Placebo Sugar Pill|"Placebo
Placebo: 400 mg/day"
477994|NCT00674765|O1|Outcome|Seroquel (Quetiapine)|"Seroquel (quetiapine)
Seroquel: 400 mg/day"
477995|NCT00674765|E2|Reported Event|Placebo|"Placebo
Placebo: 400 mg/day"
477996|NCT00674765|E1|Reported Event|Seroquel|"Seroquel
Seroquel: 400 mg/day"
477997|NCT00674817|B1|Baseline|Total Population|Eligible participants received GSK961981 400 micrograms (mcg) and 1200 mcg metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 mcg at 0 min intervals, administered via spacer) of salbutamol at 1hour (h), 12h and 24h of dosing during first and second treatment periods, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (20 mcg , 20 mcg and 40 mcg at 20 minutes intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing during third and forth treatment period, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (3 doses at 20 minutes intervals, administered via spacer) of Placebo at 1h, 12h and 24h of dosing during fifth and sixth treatment period, respectively.
477998|NCT00674817|P1|Participant Flow|Total Population|Eligible participants received GSK961981 400 micrograms (mcg) and 1200 mcg metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 mcg at 0 min intervals, administered via spacer) of salbutamol at 1hour (h), 12h and 24h of dosing during first and second treatment periods, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (20 mcg , 20 mcg and 40 mcg at 20 minutes intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing during third and forth treatment period, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (3 doses at 20 minutes intervals, administered via spacer) of Placebo at 1h, 12h and 24h of dosing during fifth and sixth treatment period, respectively.
477999|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478000|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478001|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478002|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478003|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478337|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
478004|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478005|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478006|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478007|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478008|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478009|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478010|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478011|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478691|NCT00683618|P1|Participant Flow|Rosuvastatin 5mg|Taken orally once daily
478012|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478013|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478014|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478015|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478016|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478017|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478018|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478019|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478020|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478021|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478022|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478023|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478024|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478025|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478026|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478027|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478028|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478338|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
479291|NCT00684307|E2|Reported Event|AZD0837 300 mg od|
478029|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478030|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478031|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478032|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478033|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478034|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478035|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478036|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478037|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478038|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478039|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478040|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478041|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478042|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478043|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478044|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478045|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478046|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478047|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478048|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478049|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478050|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478051|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478052|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478053|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478054|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478055|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478056|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478057|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478058|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478059|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478060|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478061|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478062|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478063|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478064|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478065|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478066|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478067|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478068|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478069|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478070|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478071|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478072|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478073|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478074|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478075|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478076|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478077|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478078|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478079|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478339|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
478525|NCT00682890|E2|Reported Event|Metformin|metformin 2000 mg and birth control pill daily
478080|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478081|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478082|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478083|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478084|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478085|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478086|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478087|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478088|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478089|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478090|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478091|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478092|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478093|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478094|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478095|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478096|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478097|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478098|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478099|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478100|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478101|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478102|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478103|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478104|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478105|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478106|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478107|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478108|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478109|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478110|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478111|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478112|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478113|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478114|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478115|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478116|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478117|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478118|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478119|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478120|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478121|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478122|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478123|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478124|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478125|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478126|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478127|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478128|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478129|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478130|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478131|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478132|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478133|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478134|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478135|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478136|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478137|NCT00674817|E6|Reported Event|1200 Microgrammes of GSK961081 and Placebo|1200 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478138|NCT00674817|E5|Reported Event|400 Microgrammes of GSK961081 and Placebo|400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
478139|NCT00674817|E4|Reported Event|1200 Microgrammes of GSK961081 and Ipratropium Bromide|1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478140|NCT00674817|E3|Reported Event|400 Microgrammes GSK961081 and Ipratropium Bromide|400 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
478263|NCT00681590|O1|Outcome|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
478141|NCT00674817|E2|Reported Event|1200 Microgrammes GSK961081 and Salbutamol|1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478142|NCT00674817|E1|Reported Event|400 Microgrammes GSK961081 and Salbutamol|400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
478143|NCT00674973|B3|Baseline|Total|Total of all reporting groups
478144|NCT00674973|B2|Baseline|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
478145|NCT00674973|B1|Baseline|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
478146|NCT00674973|P2|Participant Flow|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
478147|NCT00674973|P1|Participant Flow|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
478148|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
478149|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
478150|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
478151|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
478152|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
478153|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
478340|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
478154|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
478155|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
478156|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
478157|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
478158|NCT00674973|E2|Reported Event|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
478159|NCT00674973|E1|Reported Event|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
478160|NCT00674986|B3|Baseline|Total|Total of all reporting groups
478161|NCT00674986|B2|Baseline|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
478162|NCT00674986|B1|Baseline|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
478264|NCT00681590|O2|Outcome|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
478163|NCT00674986|P2|Participant Flow|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
478164|NCT00674986|P1|Participant Flow|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
478165|NCT00674986|O1|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
478166|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
478167|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
478168|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
478169|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
478170|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
478171|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
478172|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
478173|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
478174|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
478175|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
478176|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
478341|NCT00682357|E3|Reported Event|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
478177|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
478178|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
478179|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
478180|NCT00674986|E2|Reported Event|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
478181|NCT00674986|E1|Reported Event|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
478182|NCT00675103|B1|Baseline|Pegloticase 8 mg Every 2 Wks|
478183|NCT00675103|P1|Participant Flow|Pegloticase 8 mg Every 2 Wks|
478184|NCT00675103|O1|Outcome|Pegloticase 8 mg Every 2 Wks|
478185|NCT00675103|O1|Outcome|Pegloticase 8 mg Every 2 Wks|
478186|NCT00675103|E1|Reported Event|Pegloticase 8 mg Every 2 Wks|
478187|NCT00681473|B1|Baseline|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
478188|NCT00681473|P1|Participant Flow|Proton Radiation Therapy|Proton Radiation Therapy daily (Monday through Friday) for six weeks. This is a single arm study.
478189|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
478190|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
478191|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
478192|NCT00681473|E1|Reported Event|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
478193|NCT00681538|B3|Baseline|Total|Total of all reporting groups
478265|NCT00681590|O1|Outcome|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
478194|NCT00681538|B2|Baseline|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478195|NCT00681538|B1|Baseline|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478196|NCT00681538|P2|Participant Flow|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478197|NCT00681538|P1|Participant Flow|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478198|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478199|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478200|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478201|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478202|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478203|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478204|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478205|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478206|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478342|NCT00682357|E2|Reported Event|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
478526|NCT00682890|E1|Reported Event|Placebo|Placebo tablet and birth control pill daily
478207|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478208|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478209|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478210|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478211|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478212|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478213|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478214|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478215|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478216|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478217|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478218|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478219|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478220|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478221|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478222|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478223|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478224|NCT00681538|E2|Reported Event|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
478225|NCT00681538|E1|Reported Event|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
478226|NCT00681564|B3|Baseline|Total|Total of all reporting groups
478227|NCT00681564|B2|Baseline|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478228|NCT00681564|B1|Baseline|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478229|NCT00681564|P2|Participant Flow|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478303|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478343|NCT00682357|E1|Reported Event|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
478344|NCT00682461|B3|Baseline|Total|Total of all reporting groups
478230|NCT00681564|P1|Participant Flow|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478231|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478232|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478233|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478234|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478235|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478236|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478237|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478238|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478239|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478266|NCT00681590|E2|Reported Event|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
478692|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
478240|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478241|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478242|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478243|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478244|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478245|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478246|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478247|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478327|NCT00682357|P2|Participant Flow|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
478328|NCT00682357|P1|Participant Flow|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
478329|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
478248|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478249|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478250|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478251|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478252|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478253|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478254|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478255|NCT00681564|E2|Reported Event|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions
- Supragingival plaque removal"
478256|NCT00681564|E1|Reported Event|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
478257|NCT00681590|B3|Baseline|Total|Total of all reporting groups
478258|NCT00681590|B2|Baseline|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
478259|NCT00681590|B1|Baseline|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
478260|NCT00681590|P2|Participant Flow|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
478261|NCT00681590|P1|Participant Flow|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
478262|NCT00681590|O2|Outcome|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
478267|NCT00681590|E1|Reported Event|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
478268|NCT00681629|B3|Baseline|Total|Total of all reporting groups
478269|NCT00681629|B2|Baseline|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478270|NCT00681629|B1|Baseline|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478271|NCT00681629|P2|Participant Flow|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478272|NCT00681629|P1|Participant Flow|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478273|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478330|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
478331|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
478332|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
478527|NCT00683020|B3|Baseline|Total|Total of all reporting groups
478274|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478275|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478276|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478277|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478278|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478279|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478280|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478281|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478282|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478283|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478360|NCT00682461|E1|Reported Event|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
478284|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478285|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478286|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478287|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478333|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
478334|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
478335|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
478336|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
478288|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478289|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478290|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478291|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478292|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478293|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478294|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478295|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478296|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478297|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478298|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478361|NCT00682539|B4|Baseline|Total|Total of all reporting groups
478299|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478300|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478301|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478302|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478304|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478305|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478306|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478307|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478308|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478309|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478310|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478311|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478312|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478313|NCT00681629|E2|Reported Event|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
478362|NCT00682539|B3|Baseline|Lucentis|After a loading dose of three monthly injections of 0.5mg Lucentis, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
478401|NCT00682565|E2|Reported Event|Cohort 2 Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478693|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
478314|NCT00681629|E1|Reported Event|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.
Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
478315|NCT00681668|B1|Baseline|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
478316|NCT00681668|P1|Participant Flow|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
478317|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
478318|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
478319|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
478320|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
478321|NCT00681668|E1|Reported Event|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
478322|NCT00682357|B4|Baseline|Total|Total of all reporting groups
478323|NCT00682357|B3|Baseline|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
478324|NCT00682357|B2|Baseline|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
478325|NCT00682357|B1|Baseline|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
478326|NCT00682357|P3|Participant Flow|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
478345|NCT00682461|B2|Baseline|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
478346|NCT00682461|B1|Baseline|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
478347|NCT00682461|P2|Participant Flow|Nicotine Lozenge (2.0 mg)|Prticipants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
478348|NCT00682461|P1|Participant Flow|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
478349|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
478350|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
478351|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
478352|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
478353|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
478354|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
478355|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
478356|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
478357|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
478358|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth strip, not exceeding a maximum limit of 15 per day
478359|NCT00682461|E2|Reported Event|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum of 15 per day
478363|NCT00682539|B2|Baseline|Triamciolone|Baseline injection of 8mg intravitreally applied triamcinolone was followed by two sham injections at month 1 and 2. Sham injections were only mimicked without penetration of the ocular globe after the same pre-injection procedure. Beginning at month 3 patients were treated as needed (PRN) based on predefined morphological and functional retreatment criteria, that were reassessed monthly. Triamcinolone was injected no more than every three months intermitted by sham injections to maintain patient masking.
478364|NCT00682539|B1|Baseline|Avastin|After a loading dose of three monthly injections of 2.5mg Avastin, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
478365|NCT00682539|P3|Participant Flow|Lucentis|15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed as needed following a predefined protocol.
478366|NCT00682539|P2|Participant Flow|Triamciolone|30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed as needed following a predefined protocol. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
478367|NCT00682539|P1|Participant Flow|Avastin|15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed following a predefined protocol.
478368|NCT00682539|O3|Outcome|Lucentis|Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
478369|NCT00682539|O2|Outcome|Triamciolone|Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
478370|NCT00682539|O1|Outcome|Avastin|Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
478371|NCT00682539|O3|Outcome|Lucentis|Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
478372|NCT00682539|O2|Outcome|Triamciolone|Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
478373|NCT00682539|O1|Outcome|Avastin|Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
478374|NCT00682539|E3|Reported Event|Lucentis|15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if needed.
478375|NCT00682539|E2|Reported Event|Triamciolone|30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if needed. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
478376|NCT00682539|E1|Reported Event|Avastin|Patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed as needed.
478377|NCT00682565|B4|Baseline|Total|Total of all reporting groups
478378|NCT00682565|B3|Baseline|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478379|NCT00682565|B2|Baseline|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478380|NCT00682565|B1|Baseline|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478381|NCT00682565|P3|Participant Flow|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478382|NCT00682565|P2|Participant Flow|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478383|NCT00682565|P1|Participant Flow|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478384|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478385|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478386|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478387|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478388|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478389|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478390|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478391|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478392|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478393|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478394|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478395|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478396|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478397|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478398|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478399|NCT00682565|E4|Reported Event|Total|All Patients
478400|NCT00682565|E3|Reported Event|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478694|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
478402|NCT00682565|E1|Reported Event|Cohort 1 Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
478403|NCT00682643|B3|Baseline|Total|Total of all reporting groups
478404|NCT00682643|B2|Baseline|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478405|NCT00682643|B1|Baseline|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478406|NCT00682643|P2|Participant Flow|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478407|NCT00682643|P1|Participant Flow|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478408|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478409|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478410|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478411|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478412|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478413|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478414|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478415|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478416|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478417|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478418|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478419|NCT00682643|O1|Outcome|Placebo|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
478479|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478420|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478421|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478422|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478423|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478424|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478425|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478426|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478427|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478428|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478429|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478494|NCT00682838|O3|Outcome|SM+TC|"1+2
Self-management: Self-management
Telemonitored care: Telemonitored care"
478495|NCT00682838|O2|Outcome|Telemonitored Care|"Active Comparator
Telemonitored care: Telemonitored care"
478430|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478431|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478432|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478433|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478434|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478435|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478436|NCT00682643|E2|Reported Event|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
478437|NCT00682643|E1|Reported Event|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
478438|NCT00682734|B4|Baseline|Total|Total of all reporting groups
478439|NCT00682734|B3|Baseline|Metoclopramide 40 mg|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
478440|NCT00682734|B2|Baseline|Metoclopramide 20 mg|Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous
478441|NCT00682734|B1|Baseline|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous
478442|NCT00682734|P3|Participant Flow|Metoclopramide 40 mg Intravenous|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
478443|NCT00682734|P2|Participant Flow|Metoclopramide 20 mg Intravenous|Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous
478444|NCT00682734|P1|Participant Flow|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25mg intravenous
478445|NCT00682734|O3|Outcome|Metoclopramide 40 mg|Metoclopramide 40mg intravenous + diphenhdyramine 25mg intravenous
478446|NCT00682734|O2|Outcome|Metoclopramide 20 mg|Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous
478447|NCT00682734|O1|Outcome|Metoclopramide 10 mg Intravenous|Metoclopramide 10mg intravenous + diphenhydramine 25mg intravenous
478448|NCT00682734|E3|Reported Event|Metoclopramide 40 mg|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
478449|NCT00682734|E2|Reported Event|Metoclopramide 20 mg|Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous
478450|NCT00682734|E1|Reported Event|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous
478451|NCT00682786|B3|Baseline|Total|Total of all reporting groups
478452|NCT00682786|B2|Baseline|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478453|NCT00682786|B1|Baseline|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478454|NCT00682786|P2|Participant Flow|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478455|NCT00682786|P1|Participant Flow|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478456|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478457|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478458|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478459|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478460|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478461|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478462|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478496|NCT00682838|O1|Outcome|Self-management|"Active Intervention
Self-management: Self-management"
478497|NCT00682838|E4|Reported Event|Usual Care|Control Group
478463|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478464|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478465|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478466|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478467|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478468|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478469|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478470|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478471|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478472|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478473|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478474|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478475|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478476|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478477|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478478|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478480|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478481|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478482|NCT00682786|E2|Reported Event|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478483|NCT00682786|E1|Reported Event|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
478484|NCT00682838|B5|Baseline|Total|Total of all reporting groups
478485|NCT00682838|B4|Baseline|Usual Care|Usual care- control group
478486|NCT00682838|B3|Baseline|SM+TC|"1+2
Self-management: Self-management
Telemonitored care: Telemonitored care"
478487|NCT00682838|B2|Baseline|Telemonitored Care|"Active Comparator
Telemonitored care: Telemonitored care"
478488|NCT00682838|B1|Baseline|Self-management|"Active Intervention
Self-management: Self-management"
478489|NCT00682838|P4|Participant Flow|Usual Care|Usual care- control group
478490|NCT00682838|P3|Participant Flow|SM + TC|"1+2
Self-management: Self-management
Telemonitored care: Telemonitored care
Combination of both SM + TC intervention"
478491|NCT00682838|P2|Participant Flow|Telemonitored Care (TC)|"Active Comparator
Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol"
478492|NCT00682838|P1|Participant Flow|Self-Management (SM)|"Active Intervention
Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective"
478493|NCT00682838|O4|Outcome|Usual Care|Usual care- control group
478498|NCT00682838|E3|Reported Event|SM+TC|"1+2
Self-management: Self-management
Telemonitored care: Telemonitored care"
478499|NCT00682838|E2|Reported Event|Telemonitored Care|"Active Comparator
Telemonitored care: Telemonitored care"
478500|NCT00682838|E1|Reported Event|Self-management|"Active Intervention
Self-management: Self-management"
478501|NCT00682851|B3|Baseline|Total|Total of all reporting groups
478502|NCT00682851|B2|Baseline|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
478503|NCT00682851|B1|Baseline|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
478504|NCT00682851|P2|Participant Flow|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
478505|NCT00682851|P1|Participant Flow|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
478506|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
478507|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
478508|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
478509|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
478510|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
478511|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
478512|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
478513|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
478514|NCT00682851|E2|Reported Event|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
478515|NCT00682851|E1|Reported Event|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
478516|NCT00682890|B3|Baseline|Total|Total of all reporting groups
478517|NCT00682890|B2|Baseline|Metformin|metformin 2000 mg and birth control pill daily
478518|NCT00682890|B1|Baseline|Placebo|Placebo tablet and birth control pill daily
478519|NCT00682890|P2|Participant Flow|Metformin|metformin 2000 mg and birth control pill daily
478520|NCT00682890|P1|Participant Flow|Placebo|Placebo tablet and birth control pill daily
478521|NCT00682890|O2|Outcome|Metformin|metformin 2000 mg and birth control pill daily
478522|NCT00682890|O1|Outcome|Placebo|Placebo tablet and birth control pill daily
478523|NCT00682890|O2|Outcome|Metformin|metformin 2000 mg and birth control pill daily
478524|NCT00682890|O1|Outcome|Placebo|Placebo tablet and birth control pill daily
478528|NCT00683020|B2|Baseline|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478529|NCT00683020|B1|Baseline|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478530|NCT00683020|P2|Participant Flow|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478531|NCT00683020|P1|Participant Flow|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478532|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478533|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478534|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478535|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478536|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478537|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478538|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478539|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478540|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478541|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478542|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478543|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478544|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478545|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478546|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478547|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478548|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478549|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478550|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478551|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478552|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478553|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478554|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478555|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478556|NCT00683020|E2|Reported Event|WAIT LIST Control|WAIT LIST Control: six month Wait List.
478557|NCT00683020|E1|Reported Event|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
478558|NCT00683046|B1|Baseline|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;
Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
Melphalan 140mg/m2 IV on day -2
Stem cell infusion on day 0
Campath 20mg IV on day -7,-6,-5,-4, and -3"
478559|NCT00683046|P1|Participant Flow|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;
Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
Melphalan 140mg/m2 IV on day -2
Stem cell infusion on day 0
Campath 20mg IV on day -7,-6,-5,-4, and -3"
478560|NCT00683046|O1|Outcome|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;
Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
Melphalan 140mg/m2 IV on day -2
Stem cell infusion on day 0
Campath 20mg IV on day -7,-6,-5,-4, and -3"
478561|NCT00683046|O1|Outcome|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;
Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
Melphalan 140mg/m2 IV on day -2
Stem cell infusion on day 0
Campath 20mg IV on day -7,-6,-5,-4, and -3"
478562|NCT00683046|E1|Reported Event|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;
Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
Melphalan 140mg/m2 IV on day -2
Stem cell infusion on day 0
Campath 20mg IV on day -7,-6,-5,-4, and -3"
478563|NCT00683085|B1|Baseline|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
478564|NCT00683085|P1|Participant Flow|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
478565|NCT00683085|O1|Outcome|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
478566|NCT00683085|O1|Outcome|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
478567|NCT00683085|E1|Reported Event|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
478568|NCT00683163|B3|Baseline|Total|Total of all reporting groups
478569|NCT00683163|B2|Baseline|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
478756|NCT00683696|B2|Baseline|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
478570|NCT00683163|B1|Baseline|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
478571|NCT00683163|P2|Participant Flow|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
478572|NCT00683163|P1|Participant Flow|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily parathyroid hormone (PTH) 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
478573|NCT00683163|O2|Outcome|Sequential (B)|The Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg, followed by 9 months of monthly oral ibandronate 150 mg in year 1 and again in year 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
478574|NCT00683163|O1|Outcome|Concurrent (A)|The Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
478575|NCT00683163|O2|Outcome|Sequential (B)|The Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg, followed by 9 months of monthly oral ibandronate 150 mg in year 1 and again in year 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
478576|NCT00683163|O1|Outcome|Concurrent (A)|The Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
478577|NCT00683163|E2|Reported Event|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
478695|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
478578|NCT00683163|E1|Reported Event|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
478579|NCT00683293|B3|Baseline|Total|Total of all reporting groups
478580|NCT00683293|B2|Baseline|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
478581|NCT00683293|B1|Baseline|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy
Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
478582|NCT00683293|P2|Participant Flow|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
478583|NCT00683293|P1|Participant Flow|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy
Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
478584|NCT00683293|O2|Outcome|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
478585|NCT00683293|O1|Outcome|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy
Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
478586|NCT00683293|O2|Outcome|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
478587|NCT00683293|O1|Outcome|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy
Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
478588|NCT00683293|E2|Reported Event|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
478589|NCT00683293|E1|Reported Event|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy
Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
478590|NCT00683332|B1|Baseline|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
478591|NCT00683332|P1|Participant Flow|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
478592|NCT00683332|O1|Outcome|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
478593|NCT00683332|E1|Reported Event|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
478594|NCT00683384|B1|Baseline|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
478595|NCT00683384|P1|Participant Flow|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
478596|NCT00683384|O1|Outcome|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
478597|NCT00683384|E1|Reported Event|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
478598|NCT00683410|B1|Baseline|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
478599|NCT00683410|P1|Participant Flow|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
478600|NCT00683410|O1|Outcome|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
478601|NCT00683410|E1|Reported Event|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
478602|NCT00683449|B6|Baseline|Total|Total of all reporting groups
478603|NCT00683449|B5|Baseline|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
478604|NCT00683449|B4|Baseline|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
478605|NCT00683449|B3|Baseline|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
478606|NCT00683449|B2|Baseline|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
Spirometry completed within 10 minutes of nebulizer treatments, followed by
Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
478696|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
478697|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
478698|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
478699|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
478607|NCT00683449|B1|Baseline|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
Assessment of subject’s signs and symptoms
Completion of a dyspnea index scale
Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
Spirometry completed within 10 minutes of nebulizer treatments, followed by
Reassessment of signs and symptoms. If the subj"
478608|NCT00683449|P5|Participant Flow|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
478609|NCT00683449|P4|Participant Flow|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
478610|NCT00683449|P3|Participant Flow|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
478611|NCT00683449|P2|Participant Flow|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
Spirometry completed within 10 minutes of nebulizer treatments, followed by
Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
478612|NCT00683449|P1|Participant Flow|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
Assessment of subject’s signs and symptoms
Completion of a dyspnea index scale
Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
Spirometry completed within 10 minutes of nebulizer treatments, followed by
Reassessment of signs and symptoms. If the subj"
478613|NCT00683449|O5|Outcome|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
478614|NCT00683449|O4|Outcome|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
478640|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478757|NCT00683696|B1|Baseline|CRT=ON|Cardiac Resynchronization Therapy activated.
478615|NCT00683449|O3|Outcome|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
478616|NCT00683449|O2|Outcome|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
Spirometry completed within 10 minutes of nebulizer treatments, followed by
Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
478617|NCT00683449|O1|Outcome|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
Assessment of subject’s signs and symptoms
Completion of a dyspnea index scale
Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
Spirometry completed within 10 minutes of nebulizer treatments, followed by
Reassessment of signs and symptoms. If the subj"
478700|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
478701|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
478702|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
478618|NCT00683449|O5|Outcome|1,995 MN-221 Administered i.v. for 15 Minutes and 25 Minutes|One subject that was randomized to receive 450 MN-221 intravenously for 15 minutes was administered 1995 micrograms. Another subject that was randomized to receive 450 micrograms for 15 minutes actually received a dose of 1995 micrograms MN-221 intravenously for 25 minutes.
478619|NCT00683449|O4|Outcome|1,000-1,080 μg MN-221 Given i.v. for 15 Minutes|The Data Safety Monitoring Board recommended that subjects can receive MN-221 at 16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose 1000-1080 μg).
478620|NCT00683449|O3|Outcome|450 μg MN-221 Given i.v.|The Data Safety Monitoring Board convened and recommended that the next highest scheduled can be administered to subjects. They received MN-221 at 30 μg/minute for 15 minutes (total dose 450 μg).
478621|NCT00683449|O2|Outcome|Placebo Administered Intravenously|Initial dose group received MN-221 placebo intravenously for 15 minutes. For a subsequent dose group that was scheduled for a longer intravenous infusion of the study drug, subjects received MN-221 placebo intravenously for 15 minutes followed by MN-221 intravenously for 105 minutes.
478622|NCT00683449|O1|Outcome|MN-221 at 16.0 μg/Min for 15 Min (Total 240 μg)|The dosing scheme that consisted of a 15-minute infusion was based on PK (pharmacokinetic) modeling performed using data from the previous MN-221 studies that enrolled either healthy volunteers or subjects with stable mild to moderate asthma.
478623|NCT00683449|O5|Outcome|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
478624|NCT00683449|O4|Outcome|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
478625|NCT00683449|O3|Outcome|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
478626|NCT00683449|O2|Outcome|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
Spirometry completed within 10 minutes of nebulizer treatments, followed by
Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
478641|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478642|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478801|NCT00683800|P2|Participant Flow|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478627|NCT00683449|O1|Outcome|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
Assessment of subject’s signs and symptoms
Completion of a dyspnea index scale
Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
Spirometry completed within 10 minutes of nebulizer treatments, followed by
Reassessment of signs and symptoms. If the subj"
478628|NCT00683449|E5|Reported Event|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
478629|NCT00683449|E4|Reported Event|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
478630|NCT00683449|E3|Reported Event|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
478631|NCT00683449|E2|Reported Event|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
Spirometry completed within 10 minutes of nebulizer treatments, followed by
Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
478650|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478651|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478632|NCT00683449|E1|Reported Event|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
Assessment of subject’s signs and symptoms
Completion of a dyspnea index scale
Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
Spirometry completed within 10 minutes of nebulizer treatments, followed by
Reassessment of signs and symptoms. If the subj"
478633|NCT00683475|B3|Baseline|Total|Total of all reporting groups
478634|NCT00683475|B2|Baseline|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478635|NCT00683475|B1|Baseline|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478636|NCT00683475|P2|Participant Flow|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478637|NCT00683475|P1|Participant Flow|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478638|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478639|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478752|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
478643|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478644|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478645|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478646|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478647|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478648|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478649|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478686|NCT00683618|B3|Baseline|Atorvastatin 10mg|Taken orally once daily
478652|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478653|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478654|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478655|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478656|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478657|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478658|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478659|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478660|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478661|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478662|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478663|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478664|NCT00683475|E2|Reported Event|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478665|NCT00683475|E1|Reported Event|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
478666|NCT00683592|B3|Baseline|Total|Total of all reporting groups
478667|NCT00683592|B2|Baseline|Placebo (ITT Population)|placebo to match vilazodone
478668|NCT00683592|B1|Baseline|Vilazodone (ITT Population)|Vilazodone, 40 mg
478669|NCT00683592|P2|Participant Flow|Placebo|Placebo to match vilazodone. Two tablets per day.
478670|NCT00683592|P1|Participant Flow|Vilazodone|Vilazodone titrated to 40mg. Two tablets per day.
478671|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
478672|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
478673|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
478674|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
478675|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
478676|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
478677|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
478678|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
478679|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
478680|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
478681|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
478682|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
478683|NCT00683592|E2|Reported Event|Placebo (Safety Population)|placebo to match vilazodone
478684|NCT00683592|E1|Reported Event|Vilazodone (Safety Population)|Vilazodone, 40mg
478685|NCT00683618|B4|Baseline|Total|Total of all reporting groups
478710|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
478711|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
478712|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
478713|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
478714|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
478715|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
478716|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
478717|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
478718|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
478719|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
478720|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
478721|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
478722|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
478723|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
478724|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
478725|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
478726|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
478727|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
478728|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
478729|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
478730|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
478731|NCT00683618|O2|Outcome|Atorvastatin 10mg|Taken orally once daily
478732|NCT00683618|O1|Outcome|Rosuvastatin 10mg|Taken orally once daily
478733|NCT00683618|O2|Outcome|Atorvastatin 10mg|Taken orally once daily
478734|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
478735|NCT00683618|E3|Reported Event|Atorvastatin 10mg|Taken orally once daily
478736|NCT00683618|E2|Reported Event|Rosuvastatin 10mg|Taken orally once daily
478737|NCT00683618|E1|Reported Event|Rosuvastatin 5mg|Taken orally once daily
478738|NCT00683657|B3|Baseline|Total|Total of all reporting groups
478739|NCT00683657|B2|Baseline|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
478740|NCT00683657|B1|Baseline|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
478741|NCT00683657|P2|Participant Flow|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
478742|NCT00683657|P1|Participant Flow|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
478743|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
478744|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
478745|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
478746|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
478747|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
478748|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
478749|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
478750|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
478751|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
478758|NCT00683696|P2|Participant Flow|CRT=OFF|"Cardiac Resynchronization Therapy deactivated.
Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=OFF."
478759|NCT00683696|P1|Participant Flow|CRT=ON|"Cardiac Resynchronization Therapy activated.
Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=ON."
478760|NCT00683696|O1|Outcome|Subjects That Underwent an Implant Attempt|
478761|NCT00683696|O2|Outcome|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
478762|NCT00683696|O1|Outcome|CRT=ON|Cardiac Resynchronization Therapy activated.
478763|NCT00683696|E2|Reported Event|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
478764|NCT00683696|E1|Reported Event|CRT=ON|Cardiac Resynchronization Therapy activated.
478765|NCT00683774|B3|Baseline|Total|Total of all reporting groups
478766|NCT00683774|B2|Baseline|Normal Subjects|"Normal subjects given diazoxide
diazoxide: 100mg orally three times per day for 10 days"
478767|NCT00683774|B1|Baseline|PCOS Subjects|"PCOS subjects given diazoxide
diazoxide: 100mg orally three times per day for 10 days"
478768|NCT00683774|P2|Participant Flow|Normal Subjects|"Normal subjects given diazoxide
diazoxide: 100mg orally three times per day for 10 days"
478769|NCT00683774|P1|Participant Flow|PCOS Subjects|"PCOS subjects given diazoxide
diazoxide: 100mg orally three times per day for 10 days"
478770|NCT00683774|O2|Outcome|Normal Subjects|"Normal subjects given diazoxide
diazoxide: 100mg orally three times per day for 10 days"
478771|NCT00683774|O1|Outcome|PCOS Subjects|"PCOS subjects given diazoxide
diazoxide: 100mg orally three times per day for 10 days"
478772|NCT00683774|O2|Outcome|Normal Subjects|"Normal subjects given diazoxide
diazoxide: 100mg orally three times per day for 10 days"
478773|NCT00683774|O1|Outcome|PCOS Subjects|"PCOS subjects given diazoxide
diazoxide: 100mg orally three times per day for 10 days"
478774|NCT00683774|E2|Reported Event|Normal Subjects|"Normal subjects given diazoxide
diazoxide: 100mg orally three times per day for 10 days"
478775|NCT00683774|E1|Reported Event|PCOS Subjects|"PCOS subjects given diazoxide
diazoxide: 100mg orally three times per day for 10 days"
478776|NCT00683787|B4|Baseline|Total|Total of all reporting groups
478777|NCT00683787|B3|Baseline|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478778|NCT00683787|B2|Baseline|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478779|NCT00683787|B1|Baseline|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks"
478780|NCT00683787|P3|Participant Flow|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478781|NCT00683787|P2|Participant Flow|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478782|NCT00683787|P1|Participant Flow|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks"
478783|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478784|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478785|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks"
478786|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478787|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478788|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks"
478789|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478790|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478791|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks"
478792|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478793|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478794|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks"
478795|NCT00683787|E3|Reported Event|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478796|NCT00683787|E2|Reported Event|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily"
478797|NCT00683787|E1|Reported Event|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks"
478798|NCT00683800|B3|Baseline|Total|Total of all reporting groups
478799|NCT00683800|B2|Baseline|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478800|NCT00683800|B1|Baseline|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478802|NCT00683800|P1|Participant Flow|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478803|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478804|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478805|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478806|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478807|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478808|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478809|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478810|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478811|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478812|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478813|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478814|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478815|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478816|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478817|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478818|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478819|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478820|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478821|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478822|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478823|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478824|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478825|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478826|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478827|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478828|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478829|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478830|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478831|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478832|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478833|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478834|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478835|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478836|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478837|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478838|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478839|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478840|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478841|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478842|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478843|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478844|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478845|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478846|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478847|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478848|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478849|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478850|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478851|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478852|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478853|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478854|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478855|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478856|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478857|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478858|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478859|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478860|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478861|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478862|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478863|NCT00683800|E2|Reported Event|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
478864|NCT00683800|E1|Reported Event|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
478865|NCT00683826|B4|Baseline|Total|Total of all reporting groups
478866|NCT00683826|B3|Baseline|Leucine 0 Grams-control|Initial intervention.
478867|NCT00683826|B2|Baseline|Leucine 8 Grams|Initial intervention.
478868|NCT00683826|B1|Baseline|Leucine 4 Grams|Initial intervention.
478869|NCT00683826|P1|Participant Flow|All Study Participants|This will be a three-way crossover design, where subjects will be randomized into three groups. All subjects will receive all interventions (0g leucine, 4g leucine, 8g leucine) in a randomized order.
478870|NCT00683826|O3|Outcome|Leucine 0 Grams-control|The third arm of the study will be composed of a control drink with no leucine in it.
478871|NCT00683826|O2|Outcome|Leucine 8 Grams|Arm number two of the study will be a dose of Leucine of 8g.
478872|NCT00683826|O1|Outcome|Leucine 4 Grams|This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
478873|NCT00683826|E3|Reported Event|Leucine 0 Grams-control|The third arm of the study will be composed of a control drink with no leucine in it.
478874|NCT00683826|E2|Reported Event|Leucine 8 Grams|Arm number two of the study will be a dose of Leucine of 8g.
478875|NCT00683826|E1|Reported Event|Leucine 4 Grams|This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
478876|NCT00683852|B3|Baseline|Total|Total of all reporting groups
478877|NCT00683852|B2|Baseline|ADAPT Placebo Group (Placebo/Placebo & Placebo/Drug Groups)|This data was analyzed for the study by comparing placebo vs. drug. Therefore the two groups (placebo/placebo and placebo/drug) that started with placebo during the first phase of the study are combined as one group. Patients in the placebo/placebo sequence received a placebo treatment during the first phase of the study, and a placebo treatment in the second phase. Patients in the placebo/drug sequence received a placebo treatment during the first phase of the study and they received the aripiprazole drug at a dose of 2 mg/day in the second phase of the study.
478878|NCT00683852|B1|Baseline|ADAPT Drug/Drug Group|patients randomly assigned to the drug/drug sequence, the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase.
478879|NCT00683852|P3|Participant Flow|ADAPT Placebo/Drug Group|Patients will be randomly assigned to placebo during the first phase of the study. In the second phase of the study, they will receive the aripiprazole drug at a dose of 2 mg/day.
478880|NCT00683852|P2|Participant Flow|ADAPT Placebo/Placebo Group|Patients randomly assigned to the placebo/placebo sequence: the patients will receive a placebo treatment during the first phase of the study, and a placebo treatment in the second phase.
478881|NCT00683852|P1|Participant Flow|ADAPT Drug/Drug Group|Patients randomly assigned to the drug/drug sequence: the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase.
478882|NCT00683852|O2|Outcome|ADAPT Placebo/Placebo Group|Patients in the placebo/placebo sequence received a placebo treatment during the first phase of the study, and a placebo treatment in the second phase.
478883|NCT00683852|O1|Outcome|ADAPT Drug/Drug Group|patients randomly assigned to the drug/drug sequence, the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase
478884|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
478885|NCT00683852|O1|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
478886|NCT00683852|O2|Outcome|ADAPT Placebo Group|Placebo patient-phases from Placebo/Placebo and Placebo/Drug groups.
478887|NCT00683852|O1|Outcome|ADAPT Drug Group|Aripiprazole patient-phases from the Drug/Drug and Placebo/Drug Groups
478888|NCT00683852|O4|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
478889|NCT00683852|O3|Outcome|Phase I Placebo|Patients who received Placebo in Phase 1
478890|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
478891|NCT00683852|O1|Outcome|Phase 1 Drug|Patients who received drug in phase 1 (aripiprazole 2 mg/day)
478892|NCT00683852|O4|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
478893|NCT00683852|O3|Outcome|Phase I Placebo|Patients who received Placebo in Phase 1
478894|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
478895|NCT00683852|O1|Outcome|Phase 1 Drug|Patients who received drug in phase 1 (aripiprazole 2 mg/day)
478896|NCT00683852|O4|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
478897|NCT00683852|O3|Outcome|Phase I Placebo|Patients who received Placebo in Phase 1
478898|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
478899|NCT00683852|O1|Outcome|Phase 1 Drug|Patients who received drug in phase 1 (aripiprazole 2 mg/day)
478900|NCT00683852|O4|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
478901|NCT00683852|O3|Outcome|Phase I Placebo|Patients who received Placebo in Phase 1
478902|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
478903|NCT00683852|O1|Outcome|Phase 1 Drug|Patients who received drug in phase 1 (aripiprazole 2 mg/day)
478904|NCT00683852|O4|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
478905|NCT00683852|O3|Outcome|Phase I Placebo|Patients who received Placebo in Phase 1
478906|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
478907|NCT00683852|O1|Outcome|Phase 1 Drug|Patients who received drug in phase 1 (aripiprazole 2 mg/day)
478908|NCT00683852|E3|Reported Event|Placebo/Drug Group|Patients on placebo in Phase 1 who are on drug in phase 2 (Aripiprazole 2 mg/day)
478909|NCT00683852|E2|Reported Event|Placebo/Placebo Group|Patients on placebo in phases 1 and 2
478910|NCT00683852|E1|Reported Event|Drug/Drug Group|Aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase for drug/drug group.
478911|NCT00683878|B4|Baseline|Total|Total of all reporting groups
478912|NCT00683878|B3|Baseline|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478913|NCT00683878|B2|Baseline|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478914|NCT00683878|B1|Baseline|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478915|NCT00683878|P3|Participant Flow|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478916|NCT00683878|P2|Participant Flow|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478917|NCT00683878|P1|Participant Flow|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478918|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478919|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478920|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478921|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478922|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478923|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478924|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478925|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478926|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478927|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478928|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478929|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478930|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478931|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478932|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478933|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478934|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478935|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478936|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478937|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478938|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478939|NCT00683878|E3|Reported Event|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478940|NCT00683878|E2|Reported Event|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478941|NCT00683878|E1|Reported Event|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
478942|NCT00683904|B3|Baseline|Total|Total of all reporting groups
478943|NCT00683904|B2|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478944|NCT00683904|B1|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478945|NCT00683904|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|After all participants in Dose Level 1 have been observed for 1 full 21-day cycle, Dose Level 2 opened: Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL. infused over 30 minutes on Day 1 of each 21-day cycle.
479220|NCT00684307|B3|Baseline|450 mg od|AZD0837 450 mg od
478946|NCT00683904|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478947|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478948|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478949|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478950|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478951|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478952|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478953|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478954|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478955|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478956|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478957|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478958|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478959|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
478960|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
478961|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
478962|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
478963|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
478964|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
478965|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478966|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478967|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478968|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478969|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478970|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478971|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478972|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
478973|NCT00683904|O1|Outcome|All Treated|All subjects who received at least 1 dose of either ixabepilone or carboplatin
478974|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
478975|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
478976|NCT00683904|E2|Reported Event|Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
478977|NCT00683904|E1|Reported Event|Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
478978|NCT00683917|B4|Baseline|Total|Total of all reporting groups
478979|NCT00683917|B3|Baseline|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
478980|NCT00683917|B2|Baseline|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
478981|NCT00683917|B1|Baseline|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
478982|NCT00683917|P1|Participant Flow|Proellex All Groups|Proellex 25 mg: Proellex 50 mg, placebo, 1 capsule daily for 4 months Study prematurely terminated, no further data available
478983|NCT00683917|O3|Outcome|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
478984|NCT00683917|O2|Outcome|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
478985|NCT00683917|O1|Outcome|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
478986|NCT00683917|E3|Reported Event|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
478987|NCT00683917|E2|Reported Event|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
478988|NCT00683917|E1|Reported Event|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
478989|NCT00683930|B4|Baseline|Total|Total of all reporting groups
478990|NCT00683930|B3|Baseline|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
478991|NCT00683930|B2|Baseline|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
478992|NCT00683930|B1|Baseline|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
478993|NCT00683930|P3|Participant Flow|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
478994|NCT00683930|P2|Participant Flow|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
478995|NCT00683930|P1|Participant Flow|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
478996|NCT00683930|O4|Outcome|Mycophenolate Mofetil 3 g/Day|MMF 500 mg tablets; 6 tablets twice daily for 52 weeks
478997|NCT00683930|O3|Outcome|Mycophenolate Mofetil 2 g/Day|MMF 500 mg tablets; 4 tablets twice daily for 52 weeks
478998|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
478999|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
479000|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
479001|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
479002|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
479003|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
479004|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
479005|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
479006|NCT00683930|E3|Reported Event|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
479007|NCT00683930|E2|Reported Event|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
479008|NCT00683930|E1|Reported Event|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
479009|NCT00684021|B5|Baseline|Total|Total of all reporting groups
479010|NCT00684021|B4|Baseline|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
479011|NCT00684021|B3|Baseline|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
479012|NCT00684021|B2|Baseline|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
479013|NCT00684021|B1|Baseline|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
479014|NCT00684021|P4|Participant Flow|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
479015|NCT00684021|P3|Participant Flow|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
479016|NCT00684021|P2|Participant Flow|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
479065|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual compression was applied during the Manual Compression Primary Part (II).
479017|NCT00684021|P1|Participant Flow|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
479018|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
479019|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
479020|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
479021|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
479022|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
479023|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
479024|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
479025|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
479026|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
479027|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
479028|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
479029|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
479030|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
479031|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
479032|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
479033|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
479034|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
479035|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
479036|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
479037|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
479038|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
479039|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
479040|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
479041|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
479042|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
479043|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
479044|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
479045|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
479046|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
479047|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
479048|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
479049|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
479050|NCT00684021|E4|Reported Event|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
479051|NCT00684021|E3|Reported Event|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
479052|NCT00684021|E2|Reported Event|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
479053|NCT00684021|E1|Reported Event|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
479054|NCT00684047|B4|Baseline|Total|Total of all reporting groups
479055|NCT00684047|B3|Baseline|Manual Compression Primary Part (II)|Subjects treated with manual compression were analyzed.
479056|NCT00684047|B2|Baseline|FS Grifols Primary Part (II)|Subjects treated during FS Grifols Primary Part (II) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
479057|NCT00684047|B1|Baseline|FS Grifols Preliminary Part (I)|Subjects treated during FS Grifols Preliminary Part (I) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
479058|NCT00684047|P3|Participant Flow|Manual Compression Primary Part (II)|Manual Compression was applied in subjects in this arm.
479059|NCT00684047|P2|Participant Flow|FS Grifols Primary Part (II)|FS Grifol was applied in subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
479060|NCT00684047|P1|Participant Flow|FS Grifols Preliminary Part (I)|FS Grifols was applied in all subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
479061|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual compression was applied during the Manual Compression Primary Part (II).
479062|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
479063|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual Compression was applied in subjects in this arm.
479064|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifol was applied in subjects. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
479066|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
479067|NCT00684047|E2|Reported Event|Manual Compression Primary Part (II)|The safety population included all subjects treated with manual compression in the Manual Compression Primary Part (II). Five subjects randomized to this arm were treated with FS Grifols and thus were removed from this arm for the safety analyses.
479068|NCT00684047|E1|Reported Event|FS Grifols [Pooled Preliminary Part (I) + Primary Part (II)]|"The safety population included all subjects treated with FS Grifols in Preliminary Part (I) and Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols): Preliminary Part (I): 72 subjects and Primary Part (II): 110 subjects.
The safety population included five additional subjects treated with FS Grifols instead of manual compression who were not included in the baseline and efficacy outcome analyses."
479069|NCT00684060|B3|Baseline|Total|Total of all reporting groups
479070|NCT00684060|B2|Baseline|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
479071|NCT00684060|B1|Baseline|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
479072|NCT00684060|P2|Participant Flow|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
479073|NCT00684060|P1|Participant Flow|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
479074|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
479075|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
479076|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
479077|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
479078|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
479079|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
479080|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
479081|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
479082|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
479083|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
479084|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
479085|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
479086|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
479087|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
479088|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
479089|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
479090|NCT00684060|E2|Reported Event|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
479091|NCT00684060|E1|Reported Event|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
479092|NCT00684073|B1|Baseline|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
479093|NCT00684073|P1|Participant Flow|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
479094|NCT00684073|O5|Outcome|Day 5 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
479095|NCT00684073|O4|Outcome|Day 4 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
479096|NCT00684073|O3|Outcome|Day 3 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
479097|NCT00684073|O2|Outcome|Day 2 (Subutex®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
479098|NCT00684073|O1|Outcome|Day 1 (Subutex®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
479099|NCT00684073|E1|Reported Event|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
479100|NCT00684138|B3|Baseline|Total|Total of all reporting groups
479101|NCT00684138|B2|Baseline|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
479102|NCT00684138|B1|Baseline|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
479103|NCT00684138|P2|Participant Flow|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
479104|NCT00684138|P1|Participant Flow|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
479105|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
479106|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
479107|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
479108|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
479109|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
479110|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
479111|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
479112|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
479113|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
479114|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
479115|NCT00684138|E4|Reported Event|ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - Second eye implanted only
479116|NCT00684138|E3|Reported Event|ACRYSOF® ReSTOR® +3.0 (Second Eyes)|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - Second eye implanted only
479117|NCT00684138|E2|Reported Event|ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - First eye implanted only
479118|NCT00684138|E1|Reported Event|ACRYSOF® ReSTOR® +3.0 (First Eyes)|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - First eye implanted only
479119|NCT00684177|B3|Baseline|Total|Total of all reporting groups
479120|NCT00684177|B2|Baseline|Placebo|Matching placebo
479121|NCT00684177|B1|Baseline|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
479122|NCT00684177|P2|Participant Flow|Placebo|Matching placebo
479123|NCT00684177|P1|Participant Flow|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
479124|NCT00684177|O2|Outcome|Placebo|Matching placebo
479125|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
479126|NCT00684177|O2|Outcome|Placebo|Matching placebo
479127|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
479128|NCT00684177|O2|Outcome|Placebo|Matching placebo
479129|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
479130|NCT00684177|O2|Outcome|Placebo|Matching placebo
479131|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
479132|NCT00684177|O2|Outcome|Placebo|Matching placebo
479133|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
479134|NCT00684177|O2|Outcome|Placebo|Matching placebo
479135|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
479136|NCT00684177|E2|Reported Event|Placebo|Matching placebo
479137|NCT00684177|E1|Reported Event|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
479138|NCT00684203|B7|Baseline|Total|Total of all reporting groups
479139|NCT00684203|B6|Baseline|Placebo/Placebo (Non-PCI)|Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479140|NCT00684203|B5|Baseline|Vorapaxar 40 mg (Non-PCI)|Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479141|NCT00684203|B4|Baseline|Vorapaxar 20 mg (Non-PCI)|Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
479142|NCT00684203|B3|Baseline|Placebo/Placebo (PCI)|Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479143|NCT00684203|B2|Baseline|Vorapaxar 40 mg (PCI)|Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479144|NCT00684203|B1|Baseline|Vorapaxar 20 mg (PCI)|Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479145|NCT00684203|P6|Participant Flow|Placebo/Placebo (Non-PCI)|Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479146|NCT00684203|P5|Participant Flow|Vorapaxar 40 mg (Non-PCI)|Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479147|NCT00684203|P4|Participant Flow|Vorapaxar 20 mg (Non-PCI)|Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
479148|NCT00684203|P3|Participant Flow|Placebo/Placebo (PCI)|Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479149|NCT00684203|P2|Participant Flow|Vorapaxar 40 mg (PCI)|Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479150|NCT00684203|P1|Participant Flow|Vorapaxar 20 mg (PCI)|Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479151|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479152|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479153|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479217|NCT00684307|B6|Baseline|Total|Total of all reporting groups
479154|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479155|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479156|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479157|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479158|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479159|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479160|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479161|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479162|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479163|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479164|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479165|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479166|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479167|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479168|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479169|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479170|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479171|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479172|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479173|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479287|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479288|NCT00684307|E5|Reported Event|VKA INR 2-3|
479174|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479175|NCT00684203|O5|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479176|NCT00684203|O4|Outcome|Vorapaxar 40 mg/2.5 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479177|NCT00684203|O3|Outcome|Vorapaxar 40 mg/1 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479178|NCT00684203|O2|Outcome|Vorapaxar 20 mg/2.5 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479179|NCT00684203|O1|Outcome|Vorapaxar 20 mg/1 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479180|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479181|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479182|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479218|NCT00684307|B5|Baseline|VKA INR 2-3|
479219|NCT00684307|B4|Baseline|200 mg bd|AZD0837 200 mg bd
479183|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479184|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479185|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479186|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479187|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479188|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479189|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479190|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479191|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479192|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479193|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479194|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479195|NCT00684203|O5|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479196|NCT00684203|O4|Outcome|Vorapaxar 40 mg/2.5 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479197|NCT00684203|O3|Outcome|Vorapaxar 40 mg/1 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479198|NCT00684203|O2|Outcome|Vorapaxar 20 mg/2.5 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479199|NCT00684203|O1|Outcome|Vorapaxar 20 mg/1 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479200|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479201|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479202|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479289|NCT00684307|E4|Reported Event|AZD0837 200 mg bd|
479203|NCT00684203|E5|Reported Event|Placebo/Placebo|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479204|NCT00684203|E4|Reported Event|Vorapaxar 40 mg/2.5 mg|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479205|NCT00684203|E3|Reported Event|Vorapaxar 40 mg/1 mg|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479206|NCT00684203|E2|Reported Event|Vorapaxar 20 mg/2.5 mg|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479207|NCT00684203|E1|Reported Event|Vorapaxar 20 mg/1 mg|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
479208|NCT00684242|B1|Baseline|Lenalidomide|10 mg by mouth daily
479209|NCT00684242|P1|Participant Flow|Lenalidomide|10 mg by mouth daily
479210|NCT00684242|O1|Outcome|Lenalidomide|10 mg by mouth daily
479211|NCT00684242|E1|Reported Event|Lenalidomide|10 mg by mouth daily
479212|NCT00684255|B1|Baseline|Systemic Sclerosis (SSc)|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
479213|NCT00684255|P1|Participant Flow|Reduced Intensity Regimen SSc|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
479214|NCT00684255|O2|Outcome|Systemic Sclerosis (SSc)|Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Systemic Sclerosis (SSc)
479215|NCT00684255|O1|Outcome|Medically Refractory Systemic Lupus Erythematosus (SLE)|Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Medically Refractory Systemic Lupus Erythematosus (SLE)
479216|NCT00684255|E1|Reported Event|Reduced Intensity Regimen SSc|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
479221|NCT00684307|B2|Baseline|300 mg od|AZD0837 300 mg od
479222|NCT00684307|B1|Baseline|150 mg od|AZD0837 150 mg od
479223|NCT00684307|P5|Participant Flow|VKA INR 2-3|
479224|NCT00684307|P4|Participant Flow|200 mg bd|AZD0837 200 mg bd
479225|NCT00684307|P3|Participant Flow|450 mg od|AZD0837 450 mg od
479226|NCT00684307|P2|Participant Flow|300 mg od|AZD0837 300 mg od
479227|NCT00684307|P1|Participant Flow|150 mg od|AZD0837 150 mg od
479228|NCT00684307|O5|Outcome|VKA INR 2-3|
479229|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479230|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479231|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479232|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479233|NCT00684307|O5|Outcome|VKA INR 2-3|
479234|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479235|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479236|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479237|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479238|NCT00684307|O5|Outcome|VKA INR 2-3|
479239|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479240|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479241|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479242|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479243|NCT00684307|O5|Outcome|VKA INR 2-3|
479244|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479245|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479246|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479247|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479248|NCT00684307|O5|Outcome|VKA INR 2-3|
479249|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479250|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479251|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479252|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479253|NCT00684307|O5|Outcome|VKA INR 2-3|
479254|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479255|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479256|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479257|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479258|NCT00684307|O5|Outcome|VKA INR 2-3|
479259|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479260|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479261|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479262|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479263|NCT00684307|O5|Outcome|VKA INR 2-3|
479264|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479265|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479266|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479267|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479268|NCT00684307|O5|Outcome|VKA INR 2-3|
479269|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479270|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479271|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479272|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479273|NCT00684307|O5|Outcome|VKA INR 2-3|
479274|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479275|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479276|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479277|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479278|NCT00684307|O5|Outcome|VKA INR 2-3|
479279|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479280|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479281|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479282|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
479283|NCT00684307|O5|Outcome|VKA INR 2-3|
479284|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
479285|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
479286|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
479292|NCT00684307|E1|Reported Event|AZD0837 150 mg od|
479293|NCT00684320|B3|Baseline|Total|Total of all reporting groups
479294|NCT00684320|B2|Baseline|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
479295|NCT00684320|B1|Baseline|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.
Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
479339|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
479340|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
479341|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
479296|NCT00684320|P2|Participant Flow|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
479297|NCT00684320|P1|Participant Flow|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.
Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
479298|NCT00684320|O2|Outcome|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
479299|NCT00684320|O1|Outcome|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.
Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
479300|NCT00684320|O2|Outcome|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
479301|NCT00684320|O1|Outcome|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.
Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
479319|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479320|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479321|NCT00684424|O1|Outcome|Pregabalin|
479322|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479626|NCT00678587|O1|Outcome|Placebo|Matching placebo
479302|NCT00684320|E2|Reported Event|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
479303|NCT00684320|E1|Reported Event|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.
Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
479304|NCT00684411|B1|Baseline|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
479342|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
479343|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
479344|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
480850|NCT00681811|B3|Baseline|Total|Total of all reporting groups
479305|NCT00684411|P1|Participant Flow|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
479306|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
479307|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
479308|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
479309|NCT00684411|E1|Reported Event|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
479310|NCT00684424|B1|Baseline|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479311|NCT00684424|P1|Participant Flow|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479312|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479313|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479314|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479315|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479316|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479317|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479318|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
480372|NCT00687076|B3|Baseline|Total|Total of all reporting groups
479323|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479324|NCT00684424|E1|Reported Event|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
479325|NCT00684515|B4|Baseline|Total|Total of all reporting groups
479326|NCT00684515|B3|Baseline|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
479327|NCT00684515|B2|Baseline|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
479328|NCT00684515|B1|Baseline|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
479329|NCT00684515|P3|Participant Flow|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
479330|NCT00684515|P2|Participant Flow|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
479331|NCT00684515|P1|Participant Flow|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
479332|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
479333|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
479334|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
479335|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
479336|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
479337|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
479338|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
481482|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
479345|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
479346|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
479347|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
479348|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
479349|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
479350|NCT00684515|E3|Reported Event|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
479351|NCT00684515|E2|Reported Event|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
479352|NCT00684515|E1|Reported Event|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
479353|NCT00684541|B3|Baseline|Total|Total of all reporting groups
479354|NCT00684541|B2|Baseline|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
479355|NCT00684541|B1|Baseline|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
479356|NCT00684541|P2|Participant Flow|Interpretation Control Condition (ICC)|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
479357|NCT00684541|P1|Participant Flow|Interpretation Modification Program (IMP)|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except that participants received feedback about their responses. Specifically, participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials. Participants received negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials (76 social and 34 nonsocial) in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Thus, participants were assessed with different materials than those seen during the IMP. Each IMP session lasted approximately 20 min.
479358|NCT00684541|O2|Outcome|Interpretation Control Condition|"The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
Interpretation Control Condition: Participants assigned to the PC completed an identical procedure to the IMP procedure except that feedback about participants' performance was not contingent on the type of interpretation (i.e., non-threat or threat) endorsed. Thus, participants in the PC received positive feedback 50% of the time when viewing a threat interpretation and 50% of the time when viewing a non-threat interpretation."
479384|NCT00684593|B2|Baseline|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
479385|NCT00684593|B1|Baseline|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
479359|NCT00684541|O1|Outcome|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
479360|NCT00684541|O2|Outcome|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
479361|NCT00684541|O1|Outcome|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
479404|NCT00678210|P3|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
479405|NCT00678210|P2|Participant Flow|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
479362|NCT00684541|E2|Reported Event|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
479363|NCT00684541|E1|Reported Event|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
479364|NCT00684554|B3|Baseline|Total|Total of all reporting groups
479365|NCT00684554|B2|Baseline|Observed|"Buprenorphine Observed in office induction
Buprenorphine: Dose is determined according to the participants' individual need."
479366|NCT00684554|B1|Baseline|Unobserved-at Home|"Buprenorphine Unobserved at home induction
Buprenorphine: Dose is determined according to the participants' individual need."
479367|NCT00684554|P2|Participant Flow|Observed|"Buprenorphine Observed in office induction
Buprenorphine: Dose is determined according to the participants' individual need."
479368|NCT00684554|P1|Participant Flow|Unobserved-at Home|"Buprenorphine Unobserved at home induction
Buprenorphine: Dose is determined according to the participants' individual need."
479369|NCT00684554|O2|Outcome|Observed|"Buprenorphine Observed in office induction
Buprenorphine: Dose is determined according to the participants' individual need."
479370|NCT00684554|O1|Outcome|Unobserved-at Home|"Buprenorphine Unobserved at home induction
Buprenorphine: Dose is determined according to the participants' individual need."
479371|NCT00684554|O2|Outcome|Observed|"Buprenorphine Observed in office induction
Buprenorphine: Dose is determined according to the participants' individual need."
479372|NCT00684554|O1|Outcome|Unobserved-at Home|"Buprenorphine Unobserved at home induction
Buprenorphine: Dose is determined according to the participants' individual need."
479373|NCT00684554|E2|Reported Event|Observed|"Buprenorphine Observed in office induction
Buprenorphine: Dose is determined according to the participants' individual need."
479374|NCT00684554|E1|Reported Event|Unobserved-at Home|"Buprenorphine Unobserved at home induction
Buprenorphine: Dose is determined according to the participants' individual need."
479375|NCT00684567|B1|Baseline|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
479376|NCT00684567|P1|Participant Flow|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
479377|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
479378|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
479379|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
479380|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
479381|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
479382|NCT00684567|E1|Reported Event|Radiotherapy/Temozolomide|
479383|NCT00684593|B3|Baseline|Total|Total of all reporting groups
481523|NCT00690755|P2|Participant Flow|Group 2|Type 1 diabetic
479386|NCT00684593|P2|Participant Flow|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
479387|NCT00684593|P1|Participant Flow|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
479388|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
479389|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
479390|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
479391|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
479392|NCT00684593|O2|Outcome|Placebo|Matching placebo to SCH 527123 administered orally once daily for 28 days.
479393|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
479394|NCT00684593|O2|Outcome|Placebo|Matching placebo to SCH 527123 administered orally once daily for 28 days.
479395|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
479396|NCT00684593|E2|Reported Event|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
479397|NCT00684593|E1|Reported Event|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
479398|NCT00678210|B5|Baseline|Total|Total of all reporting groups
479399|NCT00678210|B4|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
479400|NCT00678210|B3|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
479401|NCT00678210|B2|Baseline|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
479402|NCT00678210|B1|Baseline|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
479403|NCT00678210|P4|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
479406|NCT00678210|P1|Participant Flow|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 milligram (mg) orally twice daily for 12 weeks.
479407|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
479408|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
479409|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
479410|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
479411|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
479412|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
479413|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
479414|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
479415|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
479416|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
479417|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
479418|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
479419|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
479420|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
479421|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
479422|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
479423|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
479424|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
479425|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
479426|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
479427|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
479428|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
479429|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
479430|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
479431|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
479432|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
479433|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
479434|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
479435|NCT00678210|E4|Reported Event|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
479436|NCT00678210|E3|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
479437|NCT00678210|E2|Reported Event|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
479438|NCT00678210|E1|Reported Event|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
479439|NCT00678249|B4|Baseline|Total|Total of all reporting groups
479440|NCT00678249|B3|Baseline|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479441|NCT00678249|B2|Baseline|PTA Only|Percutaneous Transluminal Angioplasty
479442|NCT00678249|B1|Baseline|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479443|NCT00678249|P3|Participant Flow|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479444|NCT00678249|P2|Participant Flow|PTA Only|Percutaneous Transluminal Angioplasty
479445|NCT00678249|P1|Participant Flow|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479446|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479447|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
479448|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479449|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479450|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
479451|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479452|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479453|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
479454|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479455|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479456|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
479457|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479458|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479459|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
479460|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479461|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479462|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
479463|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479464|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479465|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
479466|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479467|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479468|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
479469|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479470|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479471|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
479472|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479473|NCT00678249|E3|Reported Event|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
479474|NCT00678249|E2|Reported Event|PTA Only|Percutaneous Transluminal Angioplasty
479475|NCT00678249|E1|Reported Event|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
479476|NCT00678288|B3|Baseline|Total|Total of all reporting groups
479477|NCT00678288|B2|Baseline|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
479478|NCT00678288|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
479479|NCT00678288|P2|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
479480|NCT00678288|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
479481|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
479482|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
479483|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
479484|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
481524|NCT00690755|P1|Participant Flow|Group 1|Type 2 diabetic
479485|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
479486|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
479487|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
479488|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
479489|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
479490|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
479491|NCT00678288|E2|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
479492|NCT00678288|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
479493|NCT00678379|B4|Baseline|Total|Total of all reporting groups
481483|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
479494|NCT00678379|B3|Baseline|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
479495|NCT00678379|B2|Baseline|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%
lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
B - lidocaine (1%) + bupivacaine (0.5%)"
479496|NCT00678379|B1|Baseline|Normal Saline|"Normal Saline
normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
A - normal saline"
479497|NCT00678379|P3|Participant Flow|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
479498|NCT00678379|P2|Participant Flow|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%
lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
B - lidocaine (1%) + bupivacaine (0.5%)"
479499|NCT00678379|P1|Participant Flow|Normal Saline|"Normal Saline
normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
A - normal saline"
479500|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
479501|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%
lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
B - lidocaine (1%) + bupivacaine (0.5%)"
479502|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline
normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
A - normal saline"
479503|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
479504|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%
lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
B - lidocaine (1%) + bupivacaine (0.5%)"
479505|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline
normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
A - normal saline"
479506|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
479507|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%
lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
B - lidocaine (1%) + bupivacaine (0.5%)"
479508|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline
normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
A - normal saline"
479509|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
479510|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%
lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
B - lidocaine (1%) + bupivacaine (0.5%)"
479548|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479511|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline
normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
A - normal saline"
479512|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
479513|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%
lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
B - lidocaine (1%) + bupivacaine (0.5%)"
479514|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline
normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
A - normal saline"
479515|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
479516|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%
lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
B - lidocaine (1%) + bupivacaine (0.5%)"
479517|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline
normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
A - normal saline"
479518|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
479566|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
481484|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
479519|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%
lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
B - lidocaine (1%) + bupivacaine (0.5%)"
479520|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline
normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
A - normal saline"
479521|NCT00678379|E3|Reported Event|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
479522|NCT00678379|E2|Reported Event|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%
lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
B - lidocaine (1%) + bupivacaine (0.5%)"
479523|NCT00678379|E1|Reported Event|Normal Saline|"Normal Saline
normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
A - normal saline"
479524|NCT00678392|B3|Baseline|Total|Total of all reporting groups
479525|NCT00678392|B2|Baseline|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479526|NCT00678392|B1|Baseline|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479527|NCT00678392|P2|Participant Flow|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479528|NCT00678392|P1|Participant Flow|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479529|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479530|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479531|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479532|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479533|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479534|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479535|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479536|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479537|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479538|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479539|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479540|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479541|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479542|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479543|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479544|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479545|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479546|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479547|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479549|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479550|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479551|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479552|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479553|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479554|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479555|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479556|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479557|NCT00678392|E2|Reported Event|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
479558|NCT00678392|E1|Reported Event|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
479559|NCT00678418|B3|Baseline|Total|Total of all reporting groups
479560|NCT00678418|B2|Baseline|Placebo|Single intramuscular (IM) injection administered every 4 weeks
479561|NCT00678418|B1|Baseline|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
479562|NCT00678418|P2|Participant Flow|Placebo|Single intramuscular (IM) injection administered every 4 weeks
479563|NCT00678418|P1|Participant Flow|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
479564|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
479565|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
479567|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
479568|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
479569|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
479570|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
479571|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
479572|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
479573|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
479574|NCT00678418|E2|Reported Event|Placebo|Single intramuscular (IM) injection administered every 4 weeks
479575|NCT00678418|E1|Reported Event|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
479576|NCT00678470|B1|Baseline|Intralesional Alefacept|"Investigational intervention without random assignment
Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
479577|NCT00678470|P1|Participant Flow|Intralesional Alefacept|"Investigational intervention without random assignment
Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
479578|NCT00678470|O1|Outcome|Intralesional Alefacept Followed by Intramuscular Alefacept.|"Investigational intervention without random assignment
Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections to a single plaque (week 0). The plaques will be scored for response to intralesional injection (week 2). All patients will then receive intramuscular injection (week 2). The patients will then be scored for response to intramuscular injection (week 14). The number of patients who responded to both intralesional and intramuscular injection will be tabulated."
479579|NCT00678470|E1|Reported Event|Intralesional Alefacept|"Investigational intervention without random assignment
Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
479580|NCT00678535|B3|Baseline|Total|Total of all reporting groups
479581|NCT00678535|B2|Baseline|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479582|NCT00678535|B1|Baseline|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479583|NCT00678535|P2|Participant Flow|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479584|NCT00678535|P1|Participant Flow|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479585|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479625|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479586|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479587|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479588|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479589|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479590|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479591|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479592|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479593|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479594|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479595|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479596|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479597|NCT00678535|E2|Reported Event|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479598|NCT00678535|E1|Reported Event|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
479599|NCT00678574|B3|Baseline|Total|Total of all reporting groups
479600|NCT00678574|B2|Baseline|Healthy Controls|No intervention was provided to the healthy control group.
479601|NCT00678574|B1|Baseline|PMDD Group|Fluoxetine 20 mg daily by mouth for 2-3 months to the PMDD group
479602|NCT00678574|P2|Participant Flow|Healthy Controls|Participants who did not qualify for a diagnosis of PMDD and did not receive drug treatment.
479603|NCT00678574|P1|Participant Flow|PMDD|Participants who qualified as having PMDD received fluoxetine 20 mg daily by mouth for 2-3 months
479604|NCT00678574|O2|Outcome|No Intervention|No intervention was provided in the healthy control group.
479605|NCT00678574|O1|Outcome|Fluoxetine|Fluoxetine 20 mg daily by mouth for 2-3 months in PMDD group
479606|NCT00678574|E2|Reported Event|No Treatment|Healthy controls received no treatment.
479607|NCT00678574|E1|Reported Event|Fluoxetine|Fluoxetine 20 mg daily by mouth for 2-3 months in PMDD group
479608|NCT00678587|B3|Baseline|Total|Total of all reporting groups
479609|NCT00678587|B2|Baseline|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479610|NCT00678587|B1|Baseline|Placebo|Matching placebo
479611|NCT00678587|P2|Participant Flow|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479612|NCT00678587|P1|Participant Flow|Placebo|Matching placebo
479613|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479614|NCT00678587|O1|Outcome|Placebo|Matching placebo
479615|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479616|NCT00678587|O1|Outcome|Placebo|Matching placebo
479617|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479618|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479619|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479620|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479621|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479622|NCT00678587|O1|Outcome|Placebo|Matching placebo
479623|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479624|NCT00678587|O1|Outcome|Placebo|Matching placebo
479627|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479628|NCT00678587|O1|Outcome|Placebo|Matching placebo
479629|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479630|NCT00678587|O1|Outcome|Placebo|Matching placebo
479631|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479632|NCT00678587|O1|Outcome|Placebo|Matching placebo
479633|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479634|NCT00678587|O1|Outcome|Placebo|Matching placebo
479635|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479636|NCT00678587|O1|Outcome|Placebo|Matching placebo
479637|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479638|NCT00678587|O1|Outcome|Placebo|Matching placebo
479639|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479640|NCT00678587|O1|Outcome|Placebo|Matching placebo
479641|NCT00678587|E2|Reported Event|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
479642|NCT00678587|E1|Reported Event|Placebo|Matching placebo
479643|NCT00678639|B3|Baseline|Total|Total of all reporting groups
479644|NCT00678639|B2|Baseline|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
479645|NCT00678639|B1|Baseline|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
479646|NCT00678639|P2|Participant Flow|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
481485|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
479647|NCT00678639|P1|Participant Flow|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
479648|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
479649|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
479650|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
479651|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
479652|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit- Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
479653|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
479654|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
479655|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
479656|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
479657|NCT00678639|E2|Reported Event|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
479658|NCT00678639|E1|Reported Event|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
479659|NCT00678691|B3|Baseline|Total|Total of all reporting groups
479660|NCT00678691|B2|Baseline|A,2 Matching Placebo|placebo
479661|NCT00678691|B1|Baseline|A,1 Armodafinil Study Drug|armodafinil
479662|NCT00678691|P2|Participant Flow|A,2 Matching Placebo|placebo
479663|NCT00678691|P1|Participant Flow|A,1 Armodafinil Study Drug 50-250mg Flexible Dose|armodafinil
479664|NCT00678691|O2|Outcome|A,2 Matching Placebo|placebo
479665|NCT00678691|O1|Outcome|A,1 Armodafinil Study Drug|armodafinil
479666|NCT00678691|E2|Reported Event|A,2 Matching Placebo|placebo
479667|NCT00678691|E1|Reported Event|A,1 Armodafinil Study Drug|armodafinil
479668|NCT00678795|B3|Baseline|Total|Total of all reporting groups
479669|NCT00678795|B2|Baseline|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
479670|NCT00678795|B1|Baseline|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
479671|NCT00678795|P2|Participant Flow|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
479672|NCT00678795|P1|Participant Flow|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
479673|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
479674|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
479675|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
479717|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
479676|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
479677|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
479678|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
479679|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
479680|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
479681|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
479682|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
479683|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
479684|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
479685|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
479686|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
481486|NCT00690482|E2|Reported Event|Placebo|Placebo Oral tablet, twice daily
479687|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
479688|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
479689|NCT00678795|E2|Reported Event|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
479690|NCT00678795|E1|Reported Event|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
479691|NCT00678834|B4|Baseline|Total|Total of all reporting groups
479692|NCT00678834|B3|Baseline|Arm 3- Healthy + Tocotrienol 200 mg|Healthy Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
479693|NCT00678834|B2|Baseline|Arm 2 - Surgical + Tocopherol 200 mg|Surgical Subjects will recieve Tocopherol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
479694|NCT00678834|B1|Baseline|Arm 1- Surgical + Tocotrienol 200 mg|Surgical Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
479695|NCT00678834|P3|Participant Flow|Arm 3- Healthy +Tocotrienol 400 mg|Healthy patients to take Tocotrienol: 400 mg to take orally (two 200 mg capsules) two times a day.
479696|NCT00678834|P2|Participant Flow|Arm 2- Surgery + Tocopherol 200 mg|Surgery Patients to take Tocopherol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily
479697|NCT00678834|P1|Participant Flow|Arm 1- Surgery + Tocotrienol 200 mg|Surgery Patients to take Tocotrienol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily
479698|NCT00678834|O13|Outcome|Arm 3: Healthy, Blood, Week 12|Blood levels of aTE after 12 weeks of supplementation (400mg/d)
479699|NCT00678834|O12|Outcome|Arm 3: Healthy, Skin, Week 0|baseline skin levels of aTE prior to supplementation
479700|NCT00678834|O11|Outcome|Arm 3: Healthy, Skin, Week 12|skin levels of aTE after 12 weeks of supplementation (400mg/d)
479701|NCT00678834|O10|Outcome|Arm 3: Healthy, Blood, Week 6|Blood levels of aTE after 6 weeks of supplementation (400mg/d)
479702|NCT00678834|O9|Outcome|Arm 3: Healthy, Blood, Week 0|Baseline blood levels of aTE prior to supplementation
479703|NCT00678834|O8|Outcome|Arm 2: Surgical, Liver|liver aTCP levels after supplementation (400mg/d)
479704|NCT00678834|O7|Outcome|Arm 2: Surgical, Heart|heart aTCP levels after supplementation (400mg/d)
479705|NCT00678834|O6|Outcome|Arm 2: Surgical, Brain|brain aTCP levels after supplementation (400mg/d)
479706|NCT00678834|O5|Outcome|Arm 2: Surgical, Adipose|adipose aTCP levels after supplementation (400mg/d)
479707|NCT00678834|O4|Outcome|Arm 1: Surgical, Liver|liver aTE levels after supplementation (400mg/d)
479708|NCT00678834|O3|Outcome|Arm 1: Surgical, Heart|heart aTE levels after supplementation (400mg/d)
479709|NCT00678834|O2|Outcome|Arm 1: Surgical, Brain|brain aTE levels after supplementation (400mg/d)
479710|NCT00678834|O1|Outcome|Arm 1: Surgical, Adipose|adipose aTE levels after supplementation (400mg/d)
479711|NCT00678834|E3|Reported Event|Arm 3|Healthy patients to take either Tocotrienol or Tocopherol: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
479712|NCT00678834|E2|Reported Event|Arm 2|Surgery patients to take Tocopherol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
479713|NCT00678834|E1|Reported Event|Arm 1|Surgery patients to take Tocotrienol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
479714|NCT00678899|B1|Baseline|Surgery|Implantation with the Nucleus Hybrid L24 Cochlear Implant
479715|NCT00678899|P1|Participant Flow|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
479716|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
481525|NCT00690755|O7|Outcome|Group 7|Non-diabetic treated with Metformin
479718|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
479719|NCT00678899|O1|Outcome|6 Months Postactivation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
479720|NCT00678899|E1|Reported Event|Surgery|Implantation with the Nucleus Hybrid L24 Cochlear Implant
479721|NCT00684645|B1|Baseline|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479722|NCT00684645|P1|Participant Flow|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479723|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479724|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479725|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479726|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479727|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479728|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479729|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479730|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479731|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479732|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479733|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479734|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479735|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479736|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479737|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479738|NCT00684645|E1|Reported Event|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
479739|NCT00684671|B4|Baseline|Total|Total of all reporting groups
479740|NCT00684671|B3|Baseline|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
479741|NCT00684671|B2|Baseline|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
479742|NCT00684671|B1|Baseline|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
479743|NCT00684671|P3|Participant Flow|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
479744|NCT00684671|P2|Participant Flow|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
479745|NCT00684671|P1|Participant Flow|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
479746|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
479747|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
479748|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
479749|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
479750|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
479751|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
479752|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
479753|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
479754|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
479755|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
479756|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
479757|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
481526|NCT00690755|O6|Outcome|Group 6|Impaired glucose tolerance (IGT)
479758|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
479759|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
479760|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
479761|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
479762|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
479763|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
479764|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
479765|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
479766|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
479767|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
479768|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
479769|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
479828|NCT00686075|B8|Baseline|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479770|NCT00684671|E3|Reported Event|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
479771|NCT00684671|E2|Reported Event|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
479772|NCT00684671|E1|Reported Event|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
479773|NCT00684723|B1|Baseline|Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
479774|NCT00684723|P2|Participant Flow|Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
479775|NCT00684723|P1|Participant Flow|Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
479776|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
479777|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
479778|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
479779|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
479780|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
479781|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
479807|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
480098|NCT00686517|P1|Participant Flow|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
479782|NCT00684723|E2|Reported Event|Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high- calorie breakfast.
479783|NCT00684723|E1|Reported Event|Lovastatin 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
479784|NCT00684749|B1|Baseline|Total Population|All surgical patients
479785|NCT00684749|P1|Participant Flow|Total Population|All surgical patients
479786|NCT00684749|O1|Outcome|Total Population|All surgical patients
479787|NCT00684749|E1|Reported Event|Total Population|All surgical patients
479788|NCT00684762|B1|Baseline|Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
479789|NCT00684762|P2|Participant Flow|Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
479790|NCT00684762|P1|Participant Flow|Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours.
479791|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
481487|NCT00690482|E1|Reported Event|AZD1981|AZD1981 Oral tablet, twice daily
479792|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
479793|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
479794|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
479795|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
479796|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
479797|NCT00684762|E2|Reported Event|Pletal® 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
479798|NCT00684762|E1|Reported Event|Cilostazol 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
479799|NCT00684814|B1|Baseline|Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours.
479800|NCT00684814|P2|Participant Flow|Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
479801|NCT00684814|P1|Participant Flow|Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received a single tablet of the reference formulation, Ambien® 10 mg.
479802|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
479803|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
479804|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
479805|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
479806|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
479808|NCT00684814|E2|Reported Event|Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast.
479809|NCT00684814|E1|Reported Event|Zolpidem Tartrate 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast.
479810|NCT00686036|B3|Baseline|Total|Total of all reporting groups
479811|NCT00686036|B2|Baseline|Placebo|Placebo to match vandetanib 300 mg tablet
479812|NCT00686036|B1|Baseline|Vandetanib|Vandetanib 300 mg tablet
479813|NCT00686036|P2|Participant Flow|Placebo|Placebo to match vandetanib 300 mg tablet
479814|NCT00686036|P1|Participant Flow|Vandetanib|Vandetanib 300 mg tablet
479815|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
479816|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
479817|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
479818|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
479819|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
479820|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
479821|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
479822|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
479823|NCT00686036|E2|Reported Event|Placebo|Placebo to match vandetanib 300 mg tablet
479824|NCT00686036|E1|Reported Event|Vandetanib|Vandetanib 300 mg tablet
479825|NCT00686075|B11|Baseline|Total|Total of all reporting groups
479826|NCT00686075|B10|Baseline|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479827|NCT00686075|B9|Baseline|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
481488|NCT00690495|B3|Baseline|Total|Total of all reporting groups
479829|NCT00686075|B7|Baseline|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479830|NCT00686075|B6|Baseline|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479831|NCT00686075|B5|Baseline|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479832|NCT00686075|B4|Baseline|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479833|NCT00686075|B3|Baseline|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479834|NCT00686075|B2|Baseline|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479835|NCT00686075|B1|Baseline|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479836|NCT00686075|P10|Participant Flow|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479837|NCT00686075|P9|Participant Flow|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479838|NCT00686075|P8|Participant Flow|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479839|NCT00686075|P7|Participant Flow|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479840|NCT00686075|P6|Participant Flow|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479841|NCT00686075|P5|Participant Flow|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479842|NCT00686075|P4|Participant Flow|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479843|NCT00686075|P3|Participant Flow|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479844|NCT00686075|P2|Participant Flow|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479845|NCT00686075|P1|Participant Flow|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479846|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479847|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479848|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479849|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479850|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479851|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479852|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479853|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479854|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479896|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479855|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479856|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479857|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479858|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479859|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479860|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479861|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479862|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479863|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479864|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479865|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479866|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479867|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479868|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479869|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479870|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479871|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479872|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479873|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479874|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479875|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479876|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479877|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479878|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479879|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479880|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479881|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479882|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479883|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479884|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479885|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479886|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479887|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479888|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479889|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479890|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479891|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479892|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479893|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479894|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479895|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479897|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479898|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479899|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479900|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479901|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479902|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479903|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479904|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479905|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479906|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479907|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479908|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479909|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479910|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
481489|NCT00690495|B2|Baseline|Propofol 1%|Propofol 1%
479911|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479912|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479913|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479914|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479915|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479916|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479917|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479918|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479919|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479920|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479921|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479922|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479923|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479924|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479925|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479926|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479927|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479928|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479929|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479930|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479931|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479932|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479933|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479934|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479935|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479936|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479937|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479938|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479939|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479940|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479941|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479942|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479943|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479944|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479945|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479946|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479947|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479948|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479949|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479950|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479951|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
481560|NCT00690820|O1|Outcome|Placebo|Placebo treatment
479952|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479953|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479954|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479955|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479956|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479957|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479958|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479959|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479960|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479961|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479962|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479963|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479964|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479965|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479966|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479967|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479968|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479969|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479970|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479971|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479972|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479973|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479974|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479975|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479976|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479977|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479978|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479979|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479980|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479981|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479982|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479983|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479984|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479985|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479986|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479987|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479988|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479989|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479990|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479991|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
479992|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479993|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479994|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479995|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
479996|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479997|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
479998|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
479999|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
480000|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
480001|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
480002|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480003|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480004|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
480005|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
480006|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480007|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480008|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
480009|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
480010|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
480011|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
480012|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480013|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480014|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
480015|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
480016|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480017|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480018|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
480019|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
481527|NCT00690755|O5|Outcome|Group 5|Non-diabetic and Type 2 diabetic
480020|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
480021|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
480022|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480023|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480024|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
480025|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
480026|NCT00686075|E10|Reported Event|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480027|NCT00686075|E9|Reported Event|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480028|NCT00686075|E8|Reported Event|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
480029|NCT00686075|E7|Reported Event|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
480030|NCT00686075|E6|Reported Event|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
480031|NCT00686075|E5|Reported Event|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
480032|NCT00686075|E4|Reported Event|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480033|NCT00686075|E3|Reported Event|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
480034|NCT00686075|E2|Reported Event|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
480035|NCT00686075|E1|Reported Event|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
480036|NCT00686127|B3|Baseline|Total|Total of all reporting groups
480037|NCT00686127|B2|Baseline|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
480038|NCT00686127|B1|Baseline|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.
480039|NCT00686127|P2|Participant Flow|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
480040|NCT00686127|P1|Participant Flow|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.
480041|NCT00686127|O2|Outcome|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
480042|NCT00686127|O1|Outcome|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.
480043|NCT00686127|E2|Reported Event|Placebo Patch|Placebo patch: Patch is changed every 24 hours
480044|NCT00686127|E1|Reported Event|Lidocaine Patch|Lidocaine patch One patch is changed every twenty-four hours
480045|NCT00686166|B1|Baseline|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):
Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
Cetuximab, 400 mg/m^2, IV, Day 1
Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2:
Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78
Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78
Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)
Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Therapeutic Surgical procedure: Resection"
480046|NCT00686166|P1|Participant Flow|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):
Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
Cetuximab, 400 mg/m^2, IV, Day 1
Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2:
Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78
Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78
Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)
Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Therapeutic Surgical procedure: Resection"
480047|NCT00686166|O3|Outcome|Tumor Resection|Surgery must take place between 3 – 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
480048|NCT00686166|O2|Outcome|Chemotherapy + Radiation|Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
480049|NCT00686166|O1|Outcome|Chemotherapy|Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
480093|NCT00686517|B3|Baseline|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
480094|NCT00686517|B2|Baseline|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
480095|NCT00686517|B1|Baseline|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
480096|NCT00686517|P3|Participant Flow|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
480050|NCT00686166|O1|Outcome|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):
Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
Cetuximab, 400 mg/m^2, IV, Day 1
Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2:
Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78
Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78
Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)
Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Therapeutic Surgical procedure: Resection"
480051|NCT00686166|O1|Outcome|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):
Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
Cetuximab, 400 mg/m^2, IV, Day 1
Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2:
Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78
Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78
Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)
Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Therapeutic Surgical procedure: Resection"
480052|NCT00686166|E3|Reported Event|Tumor Resection|Surgery must take place between 3 – 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
480053|NCT00686166|E2|Reported Event|Chemotherapy + Radiation|Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
480054|NCT00686166|E1|Reported Event|Chemotherapy|Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
480055|NCT00686205|B3|Baseline|Total|Total of all reporting groups
480056|NCT00686205|B2|Baseline|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
480057|NCT00686205|B1|Baseline|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
481490|NCT00690495|B1|Baseline|Modified Propofol|Modified propofol (Propofol 0.5%)
480058|NCT00686205|P2|Participant Flow|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
480059|NCT00686205|P1|Participant Flow|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
480060|NCT00686205|O1|Outcome|HIV Positive Samples|Known HIV-1 or HIV-2 positive samples were used. Samples were determined to be positive by HIV-1 or HIV-2 western blot.
480061|NCT00686205|O1|Outcome|HIV Negative Donors|Donors with HIV-1/2 negative results using reference test and negative by HIV-1 RNA test
480062|NCT00686205|E2|Reported Event|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
480063|NCT00686205|E1|Reported Event|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
480064|NCT00686231|B4|Baseline|Total|Total of all reporting groups
480065|NCT00686231|B3|Baseline|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
480066|NCT00686231|B2|Baseline|Lidocaine|Lidocaine 1 inch
480067|NCT00686231|B1|Baseline|Placebo|Sorbolene cream
480068|NCT00686231|P3|Participant Flow|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
480069|NCT00686231|P2|Participant Flow|Lidocaine|Lidocaine 1 inch
480070|NCT00686231|P1|Participant Flow|Placebo|Sorbolene cream
480071|NCT00686231|O3|Outcome|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
480072|NCT00686231|O2|Outcome|Lidocaine|Lidocaine 1 inch
480073|NCT00686231|O1|Outcome|Placebo|Sorbolene cream
480074|NCT00686231|E3|Reported Event|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
480075|NCT00686231|E2|Reported Event|Lidocaine|Lidocaine 1 inch
480076|NCT00686231|E1|Reported Event|Placebo|Sorbolene cream
480077|NCT00686257|B3|Baseline|Total|Total of all reporting groups
480078|NCT00686257|B2|Baseline|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
480079|NCT00686257|B1|Baseline|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
480080|NCT00686257|P2|Participant Flow|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
480081|NCT00686257|P1|Participant Flow|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
480082|NCT00686257|O2|Outcome|Total Face Mask|Received Total Face Mask
480083|NCT00686257|O1|Outcome|Control|Received standard face mask
480084|NCT00686257|E2|Reported Event|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
480085|NCT00686257|E1|Reported Event|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
480086|NCT00686335|B1|Baseline|Safety Population|all patients that started the run-in period with Cortancyl®
480087|NCT00686335|P1|Participant Flow|Safety Population|all patients that started the run-in period with Cortancyl®
480088|NCT00686335|O2|Outcome|Cortancyl|immediate release prednisone
480089|NCT00686335|O1|Outcome|Lodotra|modified release prednisone
480090|NCT00686335|E2|Reported Event|Cortancyl|immediate release prednisone
480091|NCT00686335|E1|Reported Event|Lodotra|modified release prednisone
480092|NCT00686517|B4|Baseline|Total|Total of all reporting groups
480097|NCT00686517|P2|Participant Flow|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
480099|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
480100|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
480101|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
480102|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
480103|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
480104|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
480105|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
480106|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
480107|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
480108|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
480109|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
480110|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
480111|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
480112|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
480113|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
480114|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
480115|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
480116|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
481491|NCT00690495|P2|Participant Flow|Propofol 1%|Propofol 1%
480117|NCT00686517|E3|Reported Event|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
480118|NCT00686517|E2|Reported Event|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
480119|NCT00686517|E1|Reported Event|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
480120|NCT00686543|B5|Baseline|Total|Total of all reporting groups
480121|NCT00686543|B4|Baseline|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
480122|NCT00686543|B3|Baseline|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
480123|NCT00686543|B2|Baseline|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
480124|NCT00686543|B1|Baseline|Not Randomized|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8).
480125|NCT00686543|P4|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
480126|NCT00686543|P3|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg Twice a Day (BID) on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
480127|NCT00686543|P2|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
480128|NCT00686543|P1|Participant Flow|Not Randomized|Posaconazole oral suspension (POS) 200 mg Three Times a Day (TID) on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8)
480129|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
480130|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
480131|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
480132|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
480133|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
480134|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
480135|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
480136|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
480137|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
480138|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
480139|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
480140|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
480141|NCT00686543|E4|Reported Event|POS 400 mg TID on Days 9-15|POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements.
480142|NCT00686543|E3|Reported Event|POS 400 mg BID on Days 9-15|POS 400 mg on Days 9-15, administered with food or oral nutritional supplements.
480143|NCT00686543|E2|Reported Event|POS 200 mg TID on Days 9-15|POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements.
480144|NCT00686543|E1|Reported Event|POS 200 mg TID on Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements.
480145|NCT00686595|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480146|NCT00686595|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480147|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480148|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480149|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480150|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480151|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480152|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480153|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480154|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480155|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480156|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480157|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480158|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480159|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480160|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480161|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480162|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480163|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480164|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480165|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480166|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480167|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480168|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480221|NCT00686712|B1|Baseline|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
480169|NCT00686595|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
480170|NCT00686634|B1|Baseline|Sitagliptin Treatment|Sitagliptin 100 mg once daily
480171|NCT00686634|P1|Participant Flow|Sitagliptin Treatment|Sitagliptin 100 mg orally once daily
480172|NCT00686634|O1|Outcome|Sitagliptin|Any adverse events while receiving sitagliptin
480173|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
480174|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
480175|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
480176|NCT00686634|E1|Reported Event|Sitagliptin Treatment|Sitagliptin 100 mg once daily
480177|NCT00686647|B1|Baseline|AngioSculpt Device|
480178|NCT00686647|P1|Participant Flow|AngioSculpt Device|
480179|NCT00686647|O1|Outcome|AngioSculpt Device|
480180|NCT00686647|O1|Outcome|AngioSculpt Device|
480181|NCT00686647|O1|Outcome|Overall Study|
480182|NCT00686647|E1|Reported Event|AngioSculpt Device|
480183|NCT00686686|B1|Baseline|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
480184|NCT00686686|P1|Participant Flow|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
480185|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
480186|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
480187|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
480188|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
480189|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
480432|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480190|NCT00686686|E1|Reported Event|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
480191|NCT00686699|B3|Baseline|Total|Total of all reporting groups
480192|NCT00686699|B2|Baseline|Placebo BID→Preladenant 25 mg BID|Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
480193|NCT00686699|B1|Baseline|Preladenant 25 mg BID→Placebo BID|Participants received one preladenant 25 mg capsule BID for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
480194|NCT00686699|P2|Participant Flow|Placebo BID→Preladenant 25 mg BID|Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
480195|NCT00686699|P1|Participant Flow|Preladenant 25 mg BID→Placebo BID|Participants received one preladenant 25 mg capsule twice daily (BID) for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
480196|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
480197|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
480198|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
480199|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
480200|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
480201|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
480202|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
480203|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
480204|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
480205|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
480206|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
480207|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
480208|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
480209|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
480210|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
480211|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
480212|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
480213|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
480214|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
480215|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
480216|NCT00686699|E2|Reported Event|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
480217|NCT00686699|E1|Reported Event|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
480218|NCT00686712|B4|Baseline|Total|Total of all reporting groups
480219|NCT00686712|B3|Baseline|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
480220|NCT00686712|B2|Baseline|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
480222|NCT00686712|P3|Participant Flow|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
480223|NCT00686712|P2|Participant Flow|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
480224|NCT00686712|P1|Participant Flow|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
480225|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime
NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
480226|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning
Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
480227|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime
Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
480228|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime
NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
480229|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning
Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
480230|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime
Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
480231|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime
NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
481492|NCT00690495|P1|Participant Flow|Modified Propofol|Modified propofol (Propofol 0.5%)
480232|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning
Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
480233|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime
Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
480234|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime
NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
480235|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning
Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
480236|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime
Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
480237|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime
NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
480238|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning
Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
480239|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime
Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
480240|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime
NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
480241|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning
Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
480242|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime
Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
480243|NCT00686712|O3|Outcome|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
480244|NCT00686712|O2|Outcome|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
480245|NCT00686712|O1|Outcome|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
480246|NCT00686712|E3|Reported Event|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
480247|NCT00686712|E2|Reported Event|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
480248|NCT00686712|E1|Reported Event|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
480249|NCT00686725|B3|Baseline|Total|Total of all reporting groups
480250|NCT00686725|B2|Baseline|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480310|NCT00686855|B1|Baseline|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
480311|NCT00686855|P2|Participant Flow|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012
Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
480251|NCT00686725|B1|Baseline|Temozolomide + Radiation|"Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480252|NCT00686725|P2|Participant Flow|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480253|NCT00686725|P1|Participant Flow|Temozolomide + Radiation|"Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480274|NCT00686777|B1|Baseline|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
480327|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
480254|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480255|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480256|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480257|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480258|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480259|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480312|NCT00686855|P1|Participant Flow|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
481528|NCT00690755|O4|Outcome|Group 4|Non-diabetic overweight
480260|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480261|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480262|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480263|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
481493|NCT00690495|O2|Outcome|Propofol 1%|Propofol 1%
480264|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480265|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480266|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480267|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480268|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480269|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480270|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480271|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
480272|NCT00686725|E2|Reported Event|Temozolomide Alone, Then Temozolomide Radiation|Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
480273|NCT00686725|E1|Reported Event|Temozolomide Radiation|Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
487023|NCT00704340|O2|Outcome|Control|Standard of Care (control)
480275|NCT00686777|P1|Participant Flow|Pegylated Interferon Alfa-2b (PEG-IFN) + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
480276|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
480277|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
480278|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
480279|NCT00686777|E1|Reported Event|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
480280|NCT00686790|B1|Baseline|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
480281|NCT00686790|P1|Participant Flow|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
480282|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
480283|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
480284|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
480285|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
480286|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
480287|NCT00686790|E1|Reported Event|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
480288|NCT00686803|B4|Baseline|Total|Total of all reporting groups
480289|NCT00686803|B3|Baseline|Placebo|Placebo
480290|NCT00686803|B2|Baseline|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
480291|NCT00686803|B1|Baseline|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
480292|NCT00686803|P3|Participant Flow|Placebo|Placebo
480293|NCT00686803|P2|Participant Flow|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
480294|NCT00686803|P1|Participant Flow|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
480295|NCT00686803|O3|Outcome|Placebo|Placebo
480296|NCT00686803|O2|Outcome|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
480297|NCT00686803|O1|Outcome|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
480298|NCT00686803|O3|Outcome|Placebo|Placebo
480299|NCT00686803|O2|Outcome|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
480300|NCT00686803|O1|Outcome|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
480301|NCT00686803|E3|Reported Event|Placebo|Placebo
480302|NCT00686803|E2|Reported Event|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
480303|NCT00686803|E1|Reported Event|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
480304|NCT00686842|B1|Baseline|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
480305|NCT00686842|P1|Participant Flow|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
480306|NCT00686842|O1|Outcome|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
480307|NCT00686842|E1|Reported Event|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
480308|NCT00686855|B3|Baseline|Total|Total of all reporting groups
480309|NCT00686855|B2|Baseline|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012
Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
480313|NCT00686855|O2|Outcome|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012
Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
480314|NCT00686855|O1|Outcome|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
480315|NCT00686855|E2|Reported Event|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012
Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
480316|NCT00686855|E1|Reported Event|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
480317|NCT00686881|B3|Baseline|Total|Total of all reporting groups
480318|NCT00686881|B2|Baseline|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
480319|NCT00686881|B1|Baseline|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
480320|NCT00686881|P2|Participant Flow|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
480321|NCT00686881|P1|Participant Flow|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
480322|NCT00686881|O2|Outcome|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
480323|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
480324|NCT00686881|O2|Outcome|SNMC|Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
480325|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
480326|NCT00686881|O2|Outcome|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
480433|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480328|NCT00686881|E2|Reported Event|SNMC|"Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up
to 156 weeks."
480329|NCT00686881|E1|Reported Event|PegIFN-2b|"Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for
up to 156 weeks."
480330|NCT00686894|B1|Baseline|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
480331|NCT00686894|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
480332|NCT00686894|O1|Outcome|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
480333|NCT00686894|E1|Reported Event|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
480334|NCT00686959|B3|Baseline|Total|Total of all reporting groups
480335|NCT00686959|B2|Baseline|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
480336|NCT00686959|B1|Baseline|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
480337|NCT00686959|P2|Participant Flow|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
480338|NCT00686959|P1|Participant Flow|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 milligrams per meter squared (mg/m^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles.
Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray [Gy] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
480362|NCT00686998|B1|Baseline|AZD2624|AZD2624 40 mg
480363|NCT00686998|P3|Participant Flow|Olanzapine|Olanzapine 15 mg
480364|NCT00686998|P2|Participant Flow|Placebo|Matching Placebo
480365|NCT00686998|P1|Participant Flow|AZD2624|AZD2624 40 mg
480366|NCT00686998|O3|Outcome|Olanzapine|Olanzapine 15 mg
480367|NCT00686998|O2|Outcome|Placebo|Placebo
480368|NCT00686998|O1|Outcome|AZD2624|AZD2624 40 mg
480339|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
480340|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
480341|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
480387|NCT00687167|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
481494|NCT00690495|O1|Outcome|Modified Propofol|Modified propofol (Propofol 0.5%)
480342|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
480343|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
480344|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
480345|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
480346|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
480369|NCT00686998|E3|Reported Event|Olanzapine|Olanzapine 15 mg
480370|NCT00686998|E2|Reported Event|Placebo|Matching Placebo
480371|NCT00686998|E1|Reported Event|AZD2624|AZD2624 40 mg
480347|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
480348|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
480349|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
480350|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
481495|NCT00690495|E2|Reported Event|Propofol 1%|Propofol 1%
480351|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
480352|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
480353|NCT00686959|E2|Reported Event|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase"
480354|NCT00686959|E1|Reported Event|Arm A:|"Arm A: Participants were treated with pemetrexed plus cisplatin and concurrent thoracic radiation TRT (”Concurrent Phase”) for three 21-day cycles, followed by a 3-5 week “Recovery Period,” then treated with consolidation chemotherapy with pemetrexed (”Consolidation Phase”) for four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles."
480355|NCT00686972|B1|Baseline|GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
480356|NCT00686972|P1|Participant Flow|Glucagon Like Peptide 1 -GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
480357|NCT00686972|O1|Outcome|GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
480358|NCT00686972|E1|Reported Event|GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
480359|NCT00686998|B4|Baseline|Total|Total of all reporting groups
480360|NCT00686998|B3|Baseline|Olanzapine|Olanzapine 15 mg
480361|NCT00686998|B2|Baseline|Placebo|Matching Placebo
480373|NCT00687076|B2|Baseline|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
480374|NCT00687076|B1|Baseline|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Ezetimibe: Daily dose of 10 mg of Ezetimibe
Niaspan: Daily dose of 1500 mg of Niaspan
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
480375|NCT00687076|P2|Participant Flow|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
481496|NCT00690495|E1|Reported Event|Modified Propofol|Modified propofol (Propofol 0.5%)
480376|NCT00687076|P1|Participant Flow|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Ezetimibe: Daily dose of 10 mg of Ezetimibe
Niaspan: Daily dose of 1500 mg of Niaspan
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
480377|NCT00687076|O2|Outcome|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
480378|NCT00687076|O1|Outcome|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Ezetimibe: Daily dose of 10 mg of Ezetimibe
Niaspan: Daily dose of 1500 mg of Niaspan
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
480379|NCT00687076|O2|Outcome|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
480380|NCT00687076|O1|Outcome|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Ezetimibe: Daily dose of 10 mg of Ezetimibe
Niaspan: Daily dose of 1500 mg of Niaspan
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
480381|NCT00687076|E2|Reported Event|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
480413|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480414|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480382|NCT00687076|E1|Reported Event|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Ezetimibe: Daily dose of 10 mg of Ezetimibe
Niaspan: Daily dose of 1500 mg of Niaspan
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
480383|NCT00687167|B1|Baseline|Zonisamide 100 mg Capsules and Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
480384|NCT00687167|P2|Participant Flow|Zonegran® 100 mg Capsules Then Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast.
480385|NCT00687167|P1|Participant Flow|Zonisamide 100 mg Capsules Then Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast.
480386|NCT00687167|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
480431|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480388|NCT00687167|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
480389|NCT00687167|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
480390|NCT00687167|E2|Reported Event|Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
480391|NCT00687167|E1|Reported Event|Zonisamide 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
480392|NCT00687193|B7|Baseline|Total|Total of all reporting groups
480393|NCT00687193|B6|Baseline|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480394|NCT00687193|B5|Baseline|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480395|NCT00687193|B4|Baseline|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480396|NCT00687193|B3|Baseline|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480397|NCT00687193|B2|Baseline|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480398|NCT00687193|B1|Baseline|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480399|NCT00687193|P6|Participant Flow|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480400|NCT00687193|P5|Participant Flow|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480401|NCT00687193|P4|Participant Flow|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480402|NCT00687193|P3|Participant Flow|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480403|NCT00687193|P2|Participant Flow|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480404|NCT00687193|P1|Participant Flow|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480405|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480406|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480407|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480408|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480409|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480410|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480411|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480412|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480415|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480416|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480417|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480418|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480419|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480420|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480421|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480422|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480423|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480424|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480425|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480426|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480427|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480428|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480429|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480430|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480434|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480435|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480436|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480437|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480438|NCT00687193|O3|Outcome|CP-690,550 5 mg BID|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480439|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480440|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480441|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480442|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480443|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480444|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480445|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480446|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks
480447|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480448|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480449|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480450|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480451|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480452|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480453|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480454|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480455|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480456|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480457|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480458|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480459|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480460|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480461|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480462|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480463|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480464|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480465|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480466|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480467|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
481529|NCT00690755|O3|Outcome|Group 3|Control (non-diabetic)
480468|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480469|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480470|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480471|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480472|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480473|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480474|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480475|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480476|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480477|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480478|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480479|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480480|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480481|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480482|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480483|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
481561|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
480484|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480485|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480486|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480487|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480488|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480489|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480490|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480491|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480492|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480493|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480494|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480495|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480496|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480497|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480498|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480499|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480500|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480501|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480502|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480503|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480504|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480505|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480506|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480507|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480508|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480509|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480510|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480511|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480512|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480513|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480514|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480515|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480516|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480517|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480518|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480519|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480520|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480521|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480522|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480523|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480524|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480525|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480526|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480527|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480528|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480529|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480530|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks. Missing values were not imputed.
480531|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480532|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480533|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
481562|NCT00690820|O1|Outcome|Placebo|Placebo treatment
480534|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480535|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480536|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480537|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480538|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480539|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480540|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480541|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480542|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480543|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480544|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480545|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480546|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480547|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480548|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480549|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480550|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480551|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480552|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480553|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480554|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480555|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480556|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480557|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480558|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480559|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480560|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
480561|NCT00687193|E6|Reported Event|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
480562|NCT00687193|E5|Reported Event|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
480563|NCT00687193|E4|Reported Event|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
480564|NCT00687193|E3|Reported Event|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
480565|NCT00687193|E2|Reported Event|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
480566|NCT00687193|E1|Reported Event|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
481530|NCT00690755|O2|Outcome|Group 2|Type 1 diabetic
480567|NCT00687219|B1|Baseline|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
480568|NCT00687219|P1|Participant Flow|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
480569|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
480570|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
480571|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
480572|NCT00687219|E1|Reported Event|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
480573|NCT00687297|B3|Baseline|Total|Total of all reporting groups
480628|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480574|NCT00687297|B2|Baseline|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
480575|NCT00687297|B1|Baseline|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
480576|NCT00687297|P2|Participant Flow|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
480577|NCT00687297|P1|Participant Flow|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
480578|NCT00687297|O2|Outcome|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
480579|NCT00687297|O1|Outcome|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
480580|NCT00687297|O2|Outcome|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
480581|NCT00687297|O1|Outcome|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
480582|NCT00687297|O1|Outcome|All Randomized Patients|All patients enrolled in the study
480583|NCT00687297|E3|Reported Event|All Treated Patients - Induction|Adverse events occurring during induction among all treated patients
480584|NCT00687297|E2|Reported Event|Treated on Placebo Maintenance|Adverse events among patients receiving placebo during the maintenance phase of the study
480585|NCT00687297|E1|Reported Event|Treated on Vandetanib Maintenance|Adverse events among patients receiving Vandetanib using the maintenance phase of the study
480586|NCT00687323|B1|Baseline|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480587|NCT00687323|P1|Participant Flow|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480588|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480653|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480654|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480589|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480590|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480591|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480592|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480593|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480594|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480629|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480630|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
487470|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
480595|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480596|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480597|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480598|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480599|NCT00687323|E1|Reported Event|TEMOZOLOMIDE|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
480600|NCT00687362|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
480601|NCT00687362|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
480602|NCT00687362|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
480603|NCT00687362|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
480604|NCT00687401|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
480605|NCT00687401|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
480606|NCT00687401|O2|Outcome|Per Protocol Population|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
480607|NCT00687401|O1|Outcome|Intent to Treat Population|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
480608|NCT00687401|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
480609|NCT00687440|B1|Baseline|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.
Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
480655|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480656|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480610|NCT00687440|P1|Participant Flow|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.
Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
480611|NCT00687440|O1|Outcome|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.
Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
480612|NCT00687440|E1|Reported Event|Caelyx, Docetaxel, Trastuzumab|
480613|NCT00687453|B3|Baseline|Total|Total of all reporting groups
480614|NCT00687453|B2|Baseline|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
480615|NCT00687453|B1|Baseline|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
480616|NCT00687453|P2|Participant Flow|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
480617|NCT00687453|P1|Participant Flow|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
480618|NCT00687453|O2|Outcome|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
480619|NCT00687453|O1|Outcome|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
480620|NCT00687453|E2|Reported Event|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
480621|NCT00687453|E1|Reported Event|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
480622|NCT00687531|B1|Baseline|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480623|NCT00687531|P1|Participant Flow|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480624|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480625|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480626|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480627|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480631|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480632|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480633|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480634|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480635|NCT00687531|E1|Reported Event|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
480636|NCT00687544|B1|Baseline|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
480637|NCT00687544|P1|Participant Flow|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
480638|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
480639|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
480640|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
480641|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
480642|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
480643|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
480644|NCT00687544|E1|Reported Event|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
480645|NCT00687609|B1|Baseline|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480646|NCT00687609|P1|Participant Flow|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480647|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480648|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480649|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480650|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480651|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480652|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
481531|NCT00690755|O1|Outcome|Group 1|Type 2 diabetic
480657|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480658|NCT00687609|E1|Reported Event|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
480659|NCT00687674|B1|Baseline|Sorafenib + Lenalidomide + Dexamethasone|
480660|NCT00687674|P1|Participant Flow|Sorafenib + Lenalidomide + Dexamethasone|
480661|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
480662|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
480663|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
480664|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
480665|NCT00687674|E1|Reported Event|Sorafenib + Lenalidomide + Dexamethasone|
480666|NCT00687713|B3|Baseline|Total|Total of all reporting groups
480667|NCT00687713|B2|Baseline|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Placebo: Placebo"
480668|NCT00687713|B1|Baseline|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
480669|NCT00687713|P2|Participant Flow|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Placebo: Placebo"
480670|NCT00687713|P1|Participant Flow|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
480671|NCT00687713|O2|Outcome|Placebo|"Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Placebo: Placebo"
480672|NCT00687713|O1|Outcome|Bupropion|"Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
480673|NCT00687713|O2|Outcome|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Placebo: Placebo"
480674|NCT00687713|O1|Outcome|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
480675|NCT00687713|E2|Reported Event|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Placebo: Placebo"
480676|NCT00687713|E1|Reported Event|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
480677|NCT00687804|B4|Baseline|Total|Total of all reporting groups
480678|NCT00687804|B3|Baseline|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480679|NCT00687804|B2|Baseline|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480680|NCT00687804|B1|Baseline|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480681|NCT00687804|P3|Participant Flow|Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480779|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480682|NCT00687804|P2|Participant Flow|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480683|NCT00687804|P1|Participant Flow|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480684|NCT00687804|O3|Outcome|Active Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480685|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480686|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480687|NCT00687804|O3|Outcome|Active Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480688|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480737|NCT00687856|P1|Participant Flow|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted
Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
480828|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480689|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480690|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480691|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480760|NCT00687973|P2|Participant Flow|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480795|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
480692|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480693|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480694|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480695|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480696|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480697|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480698|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480761|NCT00687973|P1|Participant Flow|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480796|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
480699|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480700|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480701|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480702|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480703|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480704|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480705|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480762|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480797|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
480706|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480707|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480708|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480709|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480710|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480829|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480711|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480712|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480713|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480714|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480763|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480798|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
487471|NCT00693420|O2|Outcome|Vehicle Solution|
480715|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480716|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480717|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480718|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480719|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480720|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
480721|NCT00687804|E4|Reported Event|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480722|NCT00687804|E3|Reported Event|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480764|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480765|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480799|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
480723|NCT00687804|E2|Reported Event|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy"
480724|NCT00687804|E1|Reported Event|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:
Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.
Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.
Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.
In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
480725|NCT00687830|B3|Baseline|Total|Total of all reporting groups
480726|NCT00687830|B2|Baseline|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
480727|NCT00687830|B1|Baseline|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
480728|NCT00687830|P2|Participant Flow|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
480729|NCT00687830|P1|Participant Flow|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
480730|NCT00687830|O2|Outcome|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
480731|NCT00687830|O1|Outcome|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
480732|NCT00687830|O2|Outcome|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
480733|NCT00687830|O1|Outcome|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
480734|NCT00687830|E2|Reported Event|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
480735|NCT00687830|E1|Reported Event|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
480736|NCT00687856|B1|Baseline|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted
Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
480738|NCT00687856|O1|Outcome|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted
Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
480739|NCT00687856|E1|Reported Event|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted
Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
480740|NCT00687908|B3|Baseline|Total|Total of all reporting groups
480741|NCT00687908|B2|Baseline|Vehicle|Vehicle Gel
480742|NCT00687908|B1|Baseline|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
480743|NCT00687908|P2|Participant Flow|Vehicle|Vehicle Gel
480744|NCT00687908|P1|Participant Flow|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
480745|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
480746|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
480747|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
480748|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
480749|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
480750|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
480751|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
480752|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
480753|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
480754|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
480755|NCT00687908|E2|Reported Event|Vehicle|Vehicle Gel
480756|NCT00687908|E1|Reported Event|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
480757|NCT00687973|B3|Baseline|Total|Total of all reporting groups
480758|NCT00687973|B2|Baseline|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480759|NCT00687973|B1|Baseline|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480794|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
480766|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480767|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480768|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480769|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480770|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480771|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480772|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480773|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480774|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480775|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480776|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480777|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480778|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
481532|NCT00690755|E7|Reported Event|Group 7|Non-diabetic treated with Metformin
480780|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480781|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480782|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480783|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480784|NCT00687973|E3|Reported Event|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480785|NCT00687973|E2|Reported Event|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
480786|NCT00687973|E1|Reported Event|Amlodipine 5 mg|Run-in: Amlodipine 5 mg
480787|NCT00688064|B3|Baseline|Total|Total of all reporting groups
480788|NCT00688064|B2|Baseline|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
480789|NCT00688064|B1|Baseline|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
480790|NCT00688064|P2|Participant Flow|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
480791|NCT00688064|P1|Participant Flow|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
480792|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
480793|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
480800|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
480801|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
480802|NCT00688064|E2|Reported Event|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
480803|NCT00688064|E1|Reported Event|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
480804|NCT00688103|B3|Baseline|Total|Total of all reporting groups
480805|NCT00688103|B2|Baseline|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
480806|NCT00688103|B1|Baseline|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
480807|NCT00688103|P2|Participant Flow|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
480808|NCT00688103|P1|Participant Flow|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
480809|NCT00688103|O2|Outcome|ETN+MTX|"etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)
ETN+MTX: etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)"
480810|NCT00688103|O1|Outcome|ETN Alone|"etanercept (25mg, twice/week, s.c.)
ETN Alone: etanercept (25 mg, twice/week, s.c.)"
480811|NCT00688103|O2|Outcome|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
480812|NCT00688103|O1|Outcome|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
480813|NCT00688103|O2|Outcome|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
480814|NCT00688103|O1|Outcome|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
480815|NCT00688103|E2|Reported Event|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
480816|NCT00688103|E1|Reported Event|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
480817|NCT00688467|B3|Baseline|Total|Total of all reporting groups
480818|NCT00688467|B2|Baseline|Placebo → Navarixin|Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
480819|NCT00688467|B1|Baseline|Navarixin → Placebo|Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
480820|NCT00688467|P2|Participant Flow|Placebo → Navarixin|Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
480821|NCT00688467|P1|Participant Flow|Navarixin → Placebo|Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
480822|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480823|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480824|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480825|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480826|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480827|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480830|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480831|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480832|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480833|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480834|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480835|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480836|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480837|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480838|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480839|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480840|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480841|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480842|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480843|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480844|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480845|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480846|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480847|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480848|NCT00688467|E2|Reported Event|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480849|NCT00688467|E1|Reported Event|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
480851|NCT00681811|B2|Baseline|200 U/kg|Participants received 200 U/kg of HGT1111 IV infusion every other week.
480852|NCT00681811|B1|Baseline|100 U/kg HGT1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
480853|NCT00681811|P2|Participant Flow|200 U/kg HGT-1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
480854|NCT00681811|P1|Participant Flow|100 U/kg HGT-1111|Participants received 100 units per kilogram (U/kg) of HGT1111 intravenous (IV) infusion every other week.
480855|NCT00681811|O2|Outcome|200 U/kg HGT-1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
480856|NCT00681811|O1|Outcome|100 U/kg HGT-1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
480857|NCT00681811|O8|Outcome|200 U/kg HGT-1111 (Month 24)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
480858|NCT00681811|O7|Outcome|100 U/kg HGT-1111 (Month 24)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
480859|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
480860|NCT00681811|O5|Outcome|100 U/kg HGT-1111 (Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
480861|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
480862|NCT00681811|O3|Outcome|100 U/kg HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
480863|NCT00681811|O2|Outcome|200 U/kg HGT-1111 (Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
480864|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
480865|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
480866|NCT00681811|O5|Outcome|100 U/kg- HGT-1111(Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
480867|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
480868|NCT00681811|O3|Outcome|100 U/kg- HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
480869|NCT00681811|O2|Outcome|200 U/Kg-HGT-1111(Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
480870|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
480871|NCT00681811|O8|Outcome|200 U/kg HGT-1111 (Month 24)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
480872|NCT00681811|O7|Outcome|100 U/kg HGT-1111 (Month 24)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
480873|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
480874|NCT00681811|O5|Outcome|100 U/kg HGT-1111 (Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
480875|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
480876|NCT00681811|O3|Outcome|100 U/kg HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
480877|NCT00681811|O2|Outcome|200 U/kg HGT-1111 (Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
480878|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
480879|NCT00681811|E2|Reported Event|200 U/kg HGT1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
480880|NCT00681811|E1|Reported Event|100 U/kg HGT1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
480881|NCT00681824|B4|Baseline|Total|Total of all reporting groups
480882|NCT00681824|B3|Baseline|FS VH S/D 500 S-apr (Non Run-In Participants Only)|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include the 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
480883|NCT00681824|B2|Baseline|FS VH S/D 500 S-apr (Run-In Participants Only)|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group only includes the 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
480884|NCT00681824|B1|Baseline|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
480885|NCT00681824|P3|Participant Flow|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes.
480886|NCT00681824|P2|Participant Flow|Run-in Participants: FS VH S/D 500 S-apr|One initial
480887|NCT00681824|P1|Participant Flow|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
480888|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
480889|NCT00681824|O1|Outcome|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
480912|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480890|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
480891|NCT00681824|O1|Outcome|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
480892|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
480893|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
480894|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
480895|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
480896|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
480897|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
480898|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
480899|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
480900|NCT00681824|E2|Reported Event|FS VH S/D 500 S-apr|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
480901|NCT00681824|E1|Reported Event|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
480902|NCT00681863|B1|Baseline|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480903|NCT00681863|P1|Participant Flow|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID (twice daily), down-titration to 0.0625 QD (once daily) if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID (three times daily) and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
481533|NCT00690755|E6|Reported Event|Group 6|Impaired glucose tolerance (IGT)
480904|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480905|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480906|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480907|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480908|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480909|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480910|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480911|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480964|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480913|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480914|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480915|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480916|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480917|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480918|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480919|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480920|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480921|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480922|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480923|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480924|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480925|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480926|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480927|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480928|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480929|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480930|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480931|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480932|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480933|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480934|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480965|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
487472|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
480935|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480936|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480937|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480938|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480939|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480940|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480941|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480942|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480943|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480944|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480945|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480946|NCT00681863|E1|Reported Event|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
480947|NCT00681889|B1|Baseline|Treatment Arm|"10 Patients will receive treatment (Ranibizumab)
Ranibizumab : 10 Patients will receive treatment (Ranibizumab)"
480948|NCT00681889|P1|Participant Flow|Treatment Arm|"10 eyes of 9 patients will receive treatment (Ranibizumab)
Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)"
480949|NCT00681889|O1|Outcome|Treatment Arm|"9 Patients will receive treatment (Ranibizumab)
Ranibizumab : 9 Patients will receive treatment (Ranibizumab)"
481534|NCT00690755|E5|Reported Event|Group 5|Non-diabetic and Type 2 diabetic
480950|NCT00681889|E1|Reported Event|Treatment Arm|"10 eyes of 9 patients will receive treatment (Ranibizumab)
Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)"
480951|NCT00688519|B3|Baseline|Total|Total of all reporting groups
480952|NCT00688519|B2|Baseline|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480953|NCT00688519|B1|Baseline|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480954|NCT00688519|P2|Participant Flow|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480955|NCT00688519|P1|Participant Flow|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480956|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480957|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480958|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480959|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480960|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480961|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480962|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480963|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
481563|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
480966|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480967|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480968|NCT00688519|E2|Reported Event|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480969|NCT00688519|E1|Reported Event|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
480970|NCT00688545|B3|Baseline|Total|Total of all reporting groups
480971|NCT00688545|B2|Baseline|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
480972|NCT00688545|B1|Baseline|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
480973|NCT00688545|P2|Participant Flow|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
480974|NCT00688545|P1|Participant Flow|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
480975|NCT00688545|O2|Outcome|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
480976|NCT00688545|O1|Outcome|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity
480977|NCT00688545|O2|Outcome|nsNSAIDs|Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
481535|NCT00690755|E4|Reported Event|Group 4|Non-diabetic overweight
480978|NCT00688545|O1|Outcome|Celecoxib|Participants who received celecoxib at any time during the study. Treatment assignment as per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
480979|NCT00688545|E2|Reported Event|nsNSAIDs|Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
480980|NCT00688545|E1|Reported Event|Celecoxib|Participants who were prescribed celecoxib at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
480981|NCT00688636|B3|Baseline|Total|Total of all reporting groups
480982|NCT00688636|B2|Baseline|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
480983|NCT00688636|B1|Baseline|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
480984|NCT00688636|P2|Participant Flow|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
480985|NCT00688636|P1|Participant Flow|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
480986|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
480987|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
480988|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
480989|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
480990|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
480991|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
480992|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
480993|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
480994|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
480995|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
480996|NCT00688636|E2|Reported Event|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
480997|NCT00688636|E1|Reported Event|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
480998|NCT00688662|B3|Baseline|Total|Total of all reporting groups
480999|NCT00688662|B2|Baseline|2. ERCP Without Sphincterotomy|Endoscopic Retrograde CholangioPancreatography(ERCP) with sphincter manometry and pancreatic stenting, but without sphincterotomy
481000|NCT00688662|B1|Baseline|1. ERCP With Sphincterotomy|Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincter manometry and biliary and/or pancreatic sphincterotomy and pancreatic stenting
481001|NCT00688662|P2|Participant Flow|2. ERCP Without Sphincterotomy:|Endoscopic Retrograde CholangioPancreatography (ERCP) without biliary and/or pancreatic sphincterotomy
481002|NCT00688662|P1|Participant Flow|1.ERCP With Sphincterotomy|Endoscopic Retrograde CholangioPancreatography (ERCP) with biliary and/or pancreatic sphincterotomy
481003|NCT00688662|O2|Outcome|2.ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
481004|NCT00688662|O1|Outcome|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
481005|NCT00688662|O2|Outcome|2. ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
481006|NCT00688662|O1|Outcome|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
481007|NCT00688662|E2|Reported Event|2. ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
481008|NCT00688662|E1|Reported Event|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
481009|NCT00688688|B4|Baseline|Total|Total of all reporting groups
481010|NCT00688688|B3|Baseline|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481011|NCT00688688|B2|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481012|NCT00688688|B1|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481013|NCT00688688|P3|Participant Flow|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481014|NCT00688688|P2|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481015|NCT00688688|P1|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481016|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481017|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481018|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481019|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481020|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481536|NCT00690755|E3|Reported Event|Group 3|Control (non-diabetic)
481021|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481022|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481023|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481024|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481025|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481026|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481027|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481028|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481029|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481030|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481031|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481032|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481033|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481034|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481035|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481036|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481037|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481038|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481039|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481040|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481041|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481042|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481043|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481044|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481045|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481046|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481047|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481048|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481049|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481050|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481051|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481052|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481053|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481054|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481055|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481056|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481057|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481058|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481059|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481060|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481061|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481062|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481063|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481064|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481065|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481066|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481067|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481068|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481069|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481070|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481071|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481072|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481073|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481074|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481075|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481076|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481077|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481078|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481079|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481080|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481081|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481082|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481083|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481084|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481085|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481086|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481087|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481088|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481089|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481090|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481091|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481092|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481093|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481094|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481095|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481096|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481097|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481098|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481099|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481100|NCT00688688|E3|Reported Event|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
481101|NCT00688688|E2|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
481102|NCT00688688|E1|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
481103|NCT00688701|B4|Baseline|Total|Total of all reporting groups
481104|NCT00688701|B3|Baseline|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
481105|NCT00688701|B2|Baseline|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
481106|NCT00688701|B1|Baseline|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481107|NCT00688701|P4|Participant Flow|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
481108|NCT00688701|P3|Participant Flow|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
481109|NCT00688701|P2|Participant Flow|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
481110|NCT00688701|P1|Participant Flow|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
481111|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
481112|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
481113|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481114|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
481115|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
481214|NCT00689871|B1|Baseline|Primary Augmentation|All women implanted for an indication of primary breast augmentation
481116|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481117|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
481118|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
481119|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481120|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
481121|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
481122|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481123|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
481124|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
481125|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481126|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
481127|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
481128|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481129|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
481130|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
481131|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481132|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
481133|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
481134|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481135|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
481136|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
481137|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481138|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
481139|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
481140|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481141|NCT00688701|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
481142|NCT00688701|E5|Reported Event|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
481143|NCT00688701|E4|Reported Event|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
481144|NCT00688701|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
481145|NCT00688701|E2|Reported Event|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo.
481146|NCT00688701|E1|Reported Event|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo.
481147|NCT00688740|B3|Baseline|Total|Total of all reporting groups
481148|NCT00688740|B2|Baseline|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
481149|NCT00688740|B1|Baseline|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
481150|NCT00688740|P2|Participant Flow|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
481151|NCT00688740|P1|Participant Flow|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
481152|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
481153|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
481154|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
481155|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
481156|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
481157|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
481158|NCT00688740|E2|Reported Event|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
481159|NCT00688740|E1|Reported Event|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
481160|NCT00688753|B1|Baseline|RAD001 10 mg|two 5 mg tablets of everolimus orally, once daily
481161|NCT00688753|P1|Participant Flow|RAD001|two 5 mg tablets orally, once daily at the same time every day immediately after a meal
481162|NCT00688753|O1|Outcome|RAD001|10 mg/day
481163|NCT00688753|O1|Outcome|RAD001|10 mg/day
481164|NCT00688753|O1|Outcome|RAD001|10 mg/day
481165|NCT00688753|O1|Outcome|RAD001|10 mg/day
481166|NCT00688753|O1|Outcome|RAD001|10 mg/day
481167|NCT00688753|O1|Outcome|RAD001|10 mg/day
481168|NCT00688753|E1|Reported Event|All Patients|two 5 mg tablets orally, once daily at the same time every day immediately after a meal
481169|NCT00689611|B3|Baseline|Total|Total of all reporting groups
481564|NCT00690820|O1|Outcome|Placebo|Placebo treatment
481170|NCT00689611|B2|Baseline|Bupropion|"participants received bupropion for 9 weeks.
Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
481171|NCT00689611|B1|Baseline|Placebo|"participants received placebo for 9 weeks.
Placebo: Placebo"
481172|NCT00689611|P2|Participant Flow|Bupropion|"Participants received bupropion for 9 weeks.
Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks."
481173|NCT00689611|P1|Participant Flow|Placebo|Participants received placebo for 9 weeks.
481174|NCT00689611|O2|Outcome|Bupropion|"Participants received bupropion for 9 weeks.
Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
481175|NCT00689611|O1|Outcome|Placebo|Participants received placebo for 9 weeks.
481176|NCT00689611|O2|Outcome|Bupropion|"Participants received bupropion for 9 weeks.
Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
481177|NCT00689611|O1|Outcome|Placebo|Participants received placebo for 9 weeks.
481178|NCT00689611|E2|Reported Event|Bupropion|"Participants received bupropion for 9 weeks.
Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
481179|NCT00689611|E1|Reported Event|Placebo|Participants received placebo for 9 weeks.
481180|NCT00689793|B3|Baseline|Total|Total of all reporting groups
481181|NCT00689793|B2|Baseline|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
481182|NCT00689793|B1|Baseline|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
481183|NCT00689793|P2|Participant Flow|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
481184|NCT00689793|P1|Participant Flow|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
481185|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
481186|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
481187|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
481188|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
481189|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
481190|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
481191|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
481192|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
481193|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
481194|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily), during one month.
481195|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
481196|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
481197|NCT00689793|E2|Reported Event|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
481198|NCT00689793|E1|Reported Event|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
481199|NCT00689819|B3|Baseline|Total|Total of all reporting groups
481200|NCT00689819|B2|Baseline|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
481201|NCT00689819|B1|Baseline|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
481202|NCT00689819|P2|Participant Flow|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
481203|NCT00689819|P1|Participant Flow|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
481204|NCT00689819|O2|Outcome|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
481205|NCT00689819|O1|Outcome|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
481206|NCT00689819|O2|Outcome|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
481207|NCT00689819|O1|Outcome|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
481208|NCT00689819|E2|Reported Event|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
481209|NCT00689819|E1|Reported Event|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
481210|NCT00689871|B5|Baseline|Total|Total of all reporting groups
481211|NCT00689871|B4|Baseline|Revision-reconstruction|All women implanted for revision of a breast reconstruction
481212|NCT00689871|B3|Baseline|Revision-augmentation|All women implanted for revision of a breast augmentation
481213|NCT00689871|B2|Baseline|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
487473|NCT00693420|O2|Outcome|Vehicle Solution|
481215|NCT00689871|P4|Participant Flow|Revision-reconstruction|All women implanted for revision of a breast reconstruction
481216|NCT00689871|P3|Participant Flow|Revision-augmentation|All women implanted for revision of a breast augmentation
481217|NCT00689871|P2|Participant Flow|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
481218|NCT00689871|P1|Participant Flow|Primary Augmentation|All women implanted for an indication of primary breast augmentation
481219|NCT00689871|O4|Outcome|Revision-reconstruction|All women implanted for revision of a breast reconstruction
481220|NCT00689871|O3|Outcome|Revision-augmentation|All women implanted for revision of a breast augmentation
481221|NCT00689871|O2|Outcome|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
481222|NCT00689871|O1|Outcome|Primary Augmentation|All women implanted for an indication of primary breast augmentation
481223|NCT00689871|O4|Outcome|Revision-reconstruction|All women implanted for revision of a breast reconstruction
481224|NCT00689871|O3|Outcome|Revision-augmentation|All women implanted for revision of a breast augmentation
481225|NCT00689871|O2|Outcome|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
481226|NCT00689871|O1|Outcome|Primary Augmentation|All women implanted for an indication of primary breast augmentation
481227|NCT00689871|E4|Reported Event|Revision-reconstruction|All women implanted for revision of a breast reconstruction
481228|NCT00689871|E3|Reported Event|Revision-augmentation|All women implanted for revision of a breast augmentation
481229|NCT00689871|E2|Reported Event|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
481230|NCT00689871|E1|Reported Event|Primary Augmentation|All women implanted for an indication of primary breast augmentation
481231|NCT00689884|B1|Baseline|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
481232|NCT00689884|P1|Participant Flow|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
481233|NCT00689884|O1|Outcome|Group 1|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
481234|NCT00689884|O1|Outcome|Chemotherapy Plus Pegfilgrastim|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
481235|NCT00689884|E1|Reported Event|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
481236|NCT00689936|B4|Baseline|Total|Total of all reporting groups
481237|NCT00689936|B3|Baseline|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481508|NCT00690612|O1|Outcome|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
481509|NCT00690612|E1|Reported Event|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
481238|NCT00689936|B2|Baseline|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481239|NCT00689936|B1|Baseline|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481240|NCT00689936|P3|Participant Flow|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481249|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481553|NCT00690820|P2|Participant Flow|Pancrelipase/Placebo|Pancrelipase delayed release 12000 units period followed by Placebo period
481241|NCT00689936|P2|Participant Flow|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481242|NCT00689936|P1|Participant Flow|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481243|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481244|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481510|NCT00690755|B8|Baseline|Total|Total of all reporting groups
481511|NCT00690755|B7|Baseline|Group 7|Non-Diabetic treated with Metformin
481245|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481246|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481247|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481248|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481554|NCT00690820|P1|Participant Flow|Placebo/Pancrelipase|Placebo period followed by Pancrelipase delayed release 12000 units period
481250|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481251|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481252|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481253|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481254|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481255|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481256|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481257|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481555|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
481258|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481259|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481260|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481261|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481512|NCT00690755|B6|Baseline|Group 6|Impaired glucose tolerance (IGT)
481513|NCT00690755|B5|Baseline|Group 5|Non-Diabetic and Type 2 Diabetic subjected to exercise study
481514|NCT00690755|B4|Baseline|Group 4|Non-Diabetic Overweight
481262|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481263|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481264|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481265|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481443|NCT00690443|B2|Baseline|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
481444|NCT00690443|B1|Baseline|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
481266|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481267|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481268|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481285|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481269|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481270|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481271|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481272|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481273|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481445|NCT00690443|P2|Participant Flow|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
481446|NCT00690443|P1|Participant Flow|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
481556|NCT00690820|O1|Outcome|Placebo|Placebo treatment
481274|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481275|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481276|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481277|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481278|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481279|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481280|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481281|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481557|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
481282|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481283|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481284|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481286|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481287|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481288|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481289|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481447|NCT00690443|O2|Outcome|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
481448|NCT00690443|O1|Outcome|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
481290|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481291|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481292|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481309|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481293|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481294|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481295|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481296|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481297|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481449|NCT00690443|O2|Outcome|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
481450|NCT00690443|O1|Outcome|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
481558|NCT00690820|O1|Outcome|Placebo|Placebo treatment
481298|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481299|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481300|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481301|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481302|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481303|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481304|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481305|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481559|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
481306|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481307|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481308|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481310|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481311|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481312|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481313|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481451|NCT00690443|E2|Reported Event|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
481452|NCT00690443|E1|Reported Event|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
481314|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481315|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481316|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481333|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481317|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481318|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481319|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481320|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481321|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481453|NCT00690482|B3|Baseline|Total|Total of all reporting groups
481454|NCT00690482|B2|Baseline|Placebo|Placebo Oral tablet, twice daily
481455|NCT00690482|B1|Baseline|AZD1981|AZD1981 Oral tablet, twice daily
481456|NCT00690482|P2|Participant Flow|Placebo|Placebo Oral tablet, twice daily
481322|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481323|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481324|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481325|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481326|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481327|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481328|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481329|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481457|NCT00690482|P1|Participant Flow|AZD1981|AZD1981 Oral tablet, twice daily
481330|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481331|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481332|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481334|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481335|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481336|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481337|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481458|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481459|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481460|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481461|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481338|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481339|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481340|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481357|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481341|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481342|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481343|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481344|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481345|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481462|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481463|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481464|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481465|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481346|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481347|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481348|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481349|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481350|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481351|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481352|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481353|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481466|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481467|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481354|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481355|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481356|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481358|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481359|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481360|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481361|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481468|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481469|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481470|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481471|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481362|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481363|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481364|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481415|NCT00690430|P2|Participant Flow|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481515|NCT00690755|B3|Baseline|Group 3|Control (non-diabetic)
481516|NCT00690755|B2|Baseline|Group 2|Type 1 Diabetic
481365|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481366|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481367|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481368|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481369|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481472|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481473|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481474|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481475|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481370|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481371|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481372|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481373|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481374|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481375|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481376|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481377|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481476|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481477|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481378|NCT00689936|E3|Reported Event|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
481379|NCT00689936|E2|Reported Event|Lenalidomide and Dexamethasone (Rd18)|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
481416|NCT00690430|P1|Participant Flow|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481517|NCT00690755|B1|Baseline|Group 1|Type 2 diabetic
481518|NCT00690755|P7|Participant Flow|Group 7|Non-diabetic treated with Metformin
481519|NCT00690755|P6|Participant Flow|Group 6|Impaired glucose tolerance (IGT)
481520|NCT00690755|P5|Participant Flow|Group 5|Non-diabetic and Type 2 diabetic
481521|NCT00690755|P4|Participant Flow|Group 4|Non-diabetic overweight
481380|NCT00689936|E1|Reported Event|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
481381|NCT00690040|B3|Baseline|Total|Total of all reporting groups
481382|NCT00690040|B2|Baseline|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
481383|NCT00690040|B1|Baseline|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
481384|NCT00690040|P2|Participant Flow|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
481385|NCT00690040|P1|Participant Flow|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
481386|NCT00690040|O2|Outcome|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
481387|NCT00690040|O1|Outcome|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
481388|NCT00690040|E2|Reported Event|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
481389|NCT00690040|E1|Reported Event|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
481390|NCT00690339|B5|Baseline|Total|Total of all reporting groups
481391|NCT00690339|B4|Baseline|Revision-reconstruction|"Revision-reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481392|NCT00690339|B3|Baseline|Revision-augmentation|"Revision-augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481393|NCT00690339|B2|Baseline|Reconstruction|"Reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481394|NCT00690339|B1|Baseline|Augmentation|"Augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481395|NCT00690339|P4|Participant Flow|Revision-reconstruction|"Revision-reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481396|NCT00690339|P3|Participant Flow|Revision-augmentation|"Revision-augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481397|NCT00690339|P2|Participant Flow|Reconstruction|"Reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481398|NCT00690339|P1|Participant Flow|Augmentation|"Augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481399|NCT00690339|O4|Outcome|Revision-reconstruction|"Revision-reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481400|NCT00690339|O3|Outcome|Revision-augmentation|"Revision-augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481401|NCT00690339|O2|Outcome|Reconstruction|"Reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481402|NCT00690339|O1|Outcome|Augmentation|"Augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481403|NCT00690339|O4|Outcome|Revision-reconstruction|"Revision-reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481404|NCT00690339|O3|Outcome|Revision-augmentation|"Revision-augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481405|NCT00690339|O2|Outcome|Reconstruction|"Reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481406|NCT00690339|O1|Outcome|Augmentation|"Augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481407|NCT00690339|E4|Reported Event|Revision-reconstruction|"Revision-reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481408|NCT00690339|E3|Reported Event|Revision-augmentation|"Revision-augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481409|NCT00690339|E2|Reported Event|Reconstruction|"Reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481410|NCT00690339|E1|Reported Event|Augmentation|"Augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
481411|NCT00690430|B3|Baseline|Total|Total of all reporting groups
481478|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481479|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481412|NCT00690430|B2|Baseline|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481413|NCT00690430|B1|Baseline|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481414|NCT00690430|P3|Participant Flow|Extension: Octreotide LAR/Pasireotide LAR|After 6 month double blind core period, non-responders on Octreotide were given option to cross over to Pasireotide LAR in the Extension Phase of study.
481505|NCT00690612|B1|Baseline|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
481506|NCT00690612|P1|Participant Flow|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
481522|NCT00690755|P3|Participant Flow|Group 3|Control (non-diabetic)
481417|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481418|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481419|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481420|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481421|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481422|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481423|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481424|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481425|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481426|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481480|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
481481|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
481427|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481428|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481429|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481430|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481507|NCT00690612|O1|Outcome|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
481431|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481432|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481433|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481434|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481435|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481436|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481437|NCT00690430|E5|Reported Event|Crossover to Pasireotide LAR|After 6 month double blind core period, non-responders on Octreotide were given option to cross over to Pasireotide LAR in the Extension Phase of study.
481438|NCT00690430|E4|Reported Event|Extension Phase Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481439|NCT00690430|E3|Reported Event|Extension Phase Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481440|NCT00690430|E2|Reported Event|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
481441|NCT00690430|E1|Reported Event|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
481442|NCT00690443|B3|Baseline|Total|Total of all reporting groups
481497|NCT00690573|B1|Baseline|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
481498|NCT00690573|P1|Participant Flow|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
481499|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
481500|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
481501|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
481502|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
481503|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
481504|NCT00690573|E1|Reported Event|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
481537|NCT00690755|E2|Reported Event|Group 2|Type 1 diabetes
481538|NCT00690755|E1|Reported Event|Group 1|Diabetics
481539|NCT00690794|B3|Baseline|Total|Total of all reporting groups
481540|NCT00690794|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
481541|NCT00690794|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
481542|NCT00690794|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
481543|NCT00690794|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
481544|NCT00690794|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
481545|NCT00690794|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
481546|NCT00690794|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
481547|NCT00690794|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
481548|NCT00690794|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
481549|NCT00690794|E1|Reported Event|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
481550|NCT00690820|B3|Baseline|Total|Total of all reporting groups
481551|NCT00690820|B2|Baseline|Pancrelipase/Placebo|Pancrelipase delayed release 12000 units period followed by Placebo period
481552|NCT00690820|B1|Baseline|Placebo/Pancrelipase|Placebo period followed by Pancrelipase delayed release 12000 units period
481565|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
481566|NCT00690820|O1|Outcome|Placebo|Placebo treatment
481567|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
481568|NCT00690820|O1|Outcome|Placebo|Placebo treatment
481569|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
481570|NCT00690820|O1|Outcome|Placebo|Placebo treatment
481571|NCT00690820|E2|Reported Event|Pancrelipase|Pancrelipase delayed release 12000 units treatment
481572|NCT00690820|E1|Reported Event|Placebo|Placebo treatment
481573|NCT00690833|B1|Baseline|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD
topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
481574|NCT00690833|P1|Participant Flow|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD
topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
481575|NCT00690833|O1|Outcome|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD
topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
481576|NCT00690833|E1|Reported Event|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD
topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
481577|NCT00690898|B1|Baseline|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481578|NCT00690898|P1|Participant Flow|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481579|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481580|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481581|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481582|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481583|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481584|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481585|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481586|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481587|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481588|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481589|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481590|NCT00690898|E1|Reported Event|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
481591|NCT00691015|B1|Baseline|All Participants|"All regimens were analyzed together.
Standard of Care (SOC) Chemotherapy or Standard of Care (SOC) Chemotherapy + total body irradiation
SOC chemotherapy or SOC chemotherapy + total body irradiation (TBI) of one of the following regimens:
Regimen I: Patients receive fludarabine phosphate IV and busulfan IV.
Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV.
Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV.
Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV.
Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV.
Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI."
481633|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
481634|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
481592|NCT00691015|P1|Participant Flow|Conditioning Regimen|"Chemotherapy or chemotherapy + total body irradiation
Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens:
Regimen I: Patients receive fludarabine phosphate IV and busulfan IV.
Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV.
Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV.
Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV.
Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV.
Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI."
481593|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
481594|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
481595|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
481596|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
481597|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
481598|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
481599|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
481600|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
481601|NCT00691015|E1|Reported Event|Conditioning Regimen|"Chemotherapy or chemotherapy + total body irradiation
Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens:
Regimen I: Patients receive fludarabine phosphate IV and busulfan IV.
Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV.
Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV.
Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV.
Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV.
Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI."
481602|NCT00691028|B4|Baseline|Total|Total of all reporting groups
481603|NCT00691028|B3|Baseline|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
481604|NCT00691028|B2|Baseline|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
481605|NCT00691028|B1|Baseline|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
481606|NCT00691028|P4|Participant Flow|Open-label|327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
481607|NCT00691028|P3|Participant Flow|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
481608|NCT00691028|P2|Participant Flow|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
481609|NCT00691028|P1|Participant Flow|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
481610|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
481611|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
481612|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
481613|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
481614|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
481615|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
481616|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
481617|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
481618|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
481619|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
481620|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
481670|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
481621|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14..
481622|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
481623|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14..
481624|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
481625|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14..
481626|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
481627|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
481628|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
481629|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
481630|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
481631|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
481632|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
487474|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
481635|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
481636|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
481637|NCT00691028|E4|Reported Event|Open-label|327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
481638|NCT00691028|E3|Reported Event|TA-650 10 mg/kg (Double-blind)|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
481639|NCT00691028|E2|Reported Event|TA-650 6 mg/kg (Double-blind)|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
481640|NCT00691028|E1|Reported Event|TA-650 3 mg/kg (Double-blind)|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
481641|NCT00691054|B1|Baseline|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
481642|NCT00691054|P1|Participant Flow|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
481643|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
481644|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
481645|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
481646|NCT00691054|O1|Outcome|Single Arm|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
481647|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4.
481648|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
481649|NCT00691054|E1|Reported Event|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
481650|NCT00691093|B1|Baseline|Fesoterodine 4 mg|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
481651|NCT00691093|P1|Participant Flow|Fesoterodine 4 mg or 8 mg|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
481652|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 mg or 8 mg
481653|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 or 8 mg
481654|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
481655|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
481656|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
481657|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
481658|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
481659|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
481660|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
481661|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
481662|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
481663|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
481664|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
481665|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
481666|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
481667|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
481668|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
481669|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
481671|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
481672|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
481673|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
481674|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
481675|NCT00691093|O1|Outcome|All Subjects|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
481676|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 or 8 mg
481677|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
481678|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
481679|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
481680|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
481681|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
481682|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
481683|NCT00691093|E1|Reported Event|Fesoterodine 4 mg or 8 mg|All Subjects
481684|NCT00691132|B3|Baseline|Total|Total of all reporting groups
481685|NCT00691132|B2|Baseline|Placebo - PEITC (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.
phenethyl isothiocyanate: Given orally
placebo: Given orally"
487475|NCT00693420|O2|Outcome|Vehicle Solution|
481686|NCT00691132|B1|Baseline|PEITC - Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.
phenethyl isothiocyanate: Given orally
placebo: Given orally"
481687|NCT00691132|P2|Participant Flow|Placebo - PEITC (Short-term Trial)|"Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.
phenethyl isothiocyanate: Given orally
placebo: Given orally"
481688|NCT00691132|P1|Participant Flow|PEITC - Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.
phenethyl isothiocyanate: Given orally
placebo: Given orally"
481689|NCT00691132|O3|Outcome|GSTM1 and GSTT1 Both Genes Present|GSTM1 and GSTT1 Present: at least one allele positive for both glutathione-S-transferase (GST) M1 and T1, leading to higher enzymatic activity.
481690|NCT00691132|O2|Outcome|GSTM1 and GSTT1 Only One Gene Present|GSTM1 or GSTT1 Present: at least one allele positive for either the gene for glutathione-S-transferase (GST) M1 or T1, but not or both genes, leading to moderate enzymatic activity.
481691|NCT00691132|O1|Outcome|GSTM1 and GSTT1 Both Genes Null|GSTM1 & GSTT1 Null: genes for glutathione-S-transferase (GST) M1 & T1, the homozygous deletion of both genes (GSTM1 null and GSTT1 null), leading to a lack of corresponding enzymatic activity.
481692|NCT00691132|O3|Outcome|GSTM1 and GSTT1 Both Genes Present|GSTM1 and GSTT1 Present: at least one allele positive for both glutathione-S-transferase (GST) M1 and T1, leading to higher enzymatic activity.
481693|NCT00691132|O2|Outcome|GSTM1 and GSTT1 Only One Gene Present|GSTM1 or GSTT1 Present: at least one allele positive for either the gene for glutathione-S-transferase (GST) M1 or T1, but not or both genes, leading to moderate enzymatic activity.
481694|NCT00691132|O1|Outcome|GSTM1 and GSTT1 Both Genes Null|GSTM1 & GSTT1 Null: genes for glutathione-S-transferase (GST) M1 & T1, the homozygous deletion of both genes (GSTM1 null and GSTT1 null), leading to a lack of corresponding enzymatic activity.
481695|NCT00691132|O2|Outcome|GSTT1 Present|GSTT1 Present: gene for glutathione-S-transferase (GST) T1 (GSTT1), present in one or both alleles, leading to a enzymatic activity.
481696|NCT00691132|O1|Outcome|GSTT1 Null|GSTT1 Null: gene for glutathione-S-transferase (GST) T1 (GSTT1), the homozygous deletion of the gene (GSTT1 null), leading to a lack of corresponding enzymatic activity.
481697|NCT00691132|O2|Outcome|GSTM1 Present|GSTM1 Present: gene for glutathione-S-transferase (GST) M1 (GSTM1), present in one or both alleles, leading to a enzymatic activity.
481698|NCT00691132|O1|Outcome|GSTM1 Null|GSTM1 Null: gene for glutathione-S-transferase (GST) M1 (GSTM1), the homozygous deletion of the gene (GSTM1 null), leading to a lack of corresponding enzymatic activity.
481699|NCT00691132|O2|Outcome|PEITC|Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in either Period 1 or Period 2.
481700|NCT00691132|O1|Outcome|Placebo|Participants receive oral placebo four times daily for 5 days in either Period 1 or Period 2.
481701|NCT00691132|O2|Outcome|Placebo - PEITC|Participants receive oral placebo four times daily for 5 days in Period 1 and oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in Period 2, with washout period in between. Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month.
481702|NCT00691132|O1|Outcome|PEITC-Placebo|Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in Period 1 and oral placebo four times daily for 5 days in Period 2, with washout period in between. Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month.
481703|NCT00691132|E3|Reported Event|PEITC (Short-term Trial)|"Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.
phenethyl isothiocyanate: Given orally
placebo: Given orally"
481704|NCT00691132|E2|Reported Event|Washout|9 days between treatments
481705|NCT00691132|E1|Reported Event|Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.
phenethyl isothiocyanate: Given orally
placebo: Given orally"
481706|NCT00691197|B3|Baseline|Total|Total of all reporting groups
481707|NCT00691197|B2|Baseline|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
481708|NCT00691197|B1|Baseline|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
481709|NCT00691197|P2|Participant Flow|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
481710|NCT00691197|P1|Participant Flow|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
481711|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
481712|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
481713|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
481714|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
481715|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
481716|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
481717|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
481718|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
481719|NCT00691197|E2|Reported Event|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
481720|NCT00691197|E1|Reported Event|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
481721|NCT00691210|B9|Baseline|Total|Total of all reporting groups
481722|NCT00691210|B8|Baseline|V/N/E: Level 3|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2
Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
481723|NCT00691210|B7|Baseline|V/N/E: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2
Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
481724|NCT00691210|B6|Baseline|V/N/E: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2
Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
481725|NCT00691210|B5|Baseline|V/N: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481726|NCT00691210|B4|Baseline|V/N: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481727|NCT00691210|B3|Baseline|V/N: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481728|NCT00691210|B2|Baseline|V/N: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481729|NCT00691210|B1|Baseline|V/N: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481730|NCT00691210|P8|Participant Flow|V/N/E: Level 3|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2
Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
481731|NCT00691210|P7|Participant Flow|V/N/E: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2
Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
481732|NCT00691210|P6|Participant Flow|V/N/E: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2
Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
481733|NCT00691210|P5|Participant Flow|V/N: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481734|NCT00691210|P4|Participant Flow|V/N: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481735|NCT00691210|P3|Participant Flow|V/N: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481736|NCT00691210|P2|Participant Flow|V/N: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481737|NCT00691210|P1|Participant Flow|V/N: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481738|NCT00691210|O2|Outcome|Vorinostat, Niacinamide and Etoposide: Level 1-2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25-50 mg/m2
Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
481739|NCT00691210|O1|Outcome|Vorinostat (SAHA) and Niacinamide: Level 1-5|"Vorinostat: 400mg Niacinamide: 20-100 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481740|NCT00691210|O7|Outcome|Vorinostat, Niacinamide and Etoposide: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2
Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
481741|NCT00691210|O6|Outcome|Vorinostat, Niacinamide and Etoposide: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2
Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
481742|NCT00691210|O5|Outcome|Vorinostat (SAHA) and Niacinamide: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481743|NCT00691210|O4|Outcome|Vorinostat (SAHA) and Niacinamide: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481744|NCT00691210|O3|Outcome|Vorinostat (SAHA) and Niacinamide: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481745|NCT00691210|O2|Outcome|Vorinostat (SAHA) and Niacinamide: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481746|NCT00691210|O1|Outcome|Vorinostat (SAHA) and Niacinamide: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481747|NCT00691210|E7|Reported Event|Vorinostat, Niacinamide and Etoposide: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2
Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
481748|NCT00691210|E6|Reported Event|Vorinostat, Niacinamide and Etoposide: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2
Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
481749|NCT00691210|E5|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481750|NCT00691210|E4|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481751|NCT00691210|E3|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481752|NCT00691210|E2|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481753|NCT00691210|E1|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg
Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
481754|NCT00691327|B3|Baseline|Total|Total of all reporting groups
481755|NCT00691327|B2|Baseline|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
481756|NCT00691327|B1|Baseline|Reconstruction|Women who have undergone Breast Reconstruction
481757|NCT00691327|P2|Participant Flow|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
481758|NCT00691327|P1|Participant Flow|Reconstruction|Women who have undergone Breast Reconstruction
481759|NCT00691327|O2|Outcome|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
481760|NCT00691327|O1|Outcome|Reconstruction|Women who have undergone Breast Reconstruction
481761|NCT00691327|O2|Outcome|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
481762|NCT00691327|O1|Outcome|Reconstruction|Women who have undergone Breast Reconstruction
481763|NCT00691327|E2|Reported Event|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
481764|NCT00691327|E1|Reported Event|Reconstruction|Women who have undergone Breast Reconstruction
481765|NCT00691483|B3|Baseline|Total|Total of all reporting groups
481766|NCT00691483|B2|Baseline|Placebo|Placebo matched to varenicline.
481767|NCT00691483|B1|Baseline|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
481768|NCT00691483|P2|Participant Flow|Placebo|Placebo matched to varenicline.
481769|NCT00691483|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
481770|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
481771|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
481772|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
481773|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
481774|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
481775|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
481776|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
481777|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
481778|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
481779|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
481780|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
481781|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
481782|NCT00691483|E2|Reported Event|Placebo|Placebo matched to varenicline.
481783|NCT00691483|E1|Reported Event|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
481830|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481831|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
481832|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481784|NCT00691652|B1|Baseline|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).
Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV
Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg
Phase II:
Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
481785|NCT00691652|P1|Participant Flow|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).
Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV
Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg
Phase II:
Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
481786|NCT00691652|O1|Outcome|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).
Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV
Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg
Phase II:
Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
481787|NCT00691652|E1|Reported Event|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).
Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV
Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg
Phase II:
Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
481788|NCT00691665|B3|Baseline|Total|Total of all reporting groups
487476|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
481789|NCT00691665|B2|Baseline|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
481790|NCT00691665|B1|Baseline|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
481791|NCT00691665|P2|Participant Flow|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
481792|NCT00691665|P1|Participant Flow|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
481793|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
481794|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
481795|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
481796|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
481797|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
481798|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
481799|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
481800|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
481801|NCT00691665|E2|Reported Event|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
481802|NCT00691665|E1|Reported Event|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
481803|NCT00691704|B1|Baseline|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy
Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.
Maintenance Therapy: Subjects who achieve >partial response (PR) after induction will receive repeating triplet 28-day cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance:
325 mg aspirin for deep vein thrombosis (DVT) prophylaxis
Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8
Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7
Prednisone 60 mg /m2 po daily on Days 1-7
Cycle 3, 6, 9, etc. Lenalidomide 10 mg po daily on Days 1-21."
481804|NCT00691704|P1|Participant Flow|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy
Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.
Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):
325 mg aspirin for deep vein thrombosis (DVT) prophylaxis
Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle
Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7
Prednisone 60 mg /m2 po daily on"
481805|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy
Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.
Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):
325 mg aspirin for deep vein thrombosis (DVT) prophylaxis
Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle
Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7
Prednisone 60 mg /m2 po daily on"
481806|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy
Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.
Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):
325 mg aspirin for deep vein thrombosis (DVT) prophylaxis
Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle
Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7
Prednisone 60 mg /m2 po daily on"
481807|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy
Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.
Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):
325 mg aspirin for deep vein thrombosis (DVT) prophylaxis
Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle
Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7
Prednisone 60 mg /m2 po daily on"
481850|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481851|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481852|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
481808|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy
Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.
Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):
325 mg aspirin for deep vein thrombosis (DVT) prophylaxis
Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle
Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7
Prednisone 60 mg /m2 po daily on"
481809|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy
Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.
Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):
325 mg aspirin for deep vein thrombosis (DVT) prophylaxis
Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle
Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7
Prednisone 60 mg /m2 po daily on"
481810|NCT00691704|E1|Reported Event|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy
Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.
Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):
325 mg aspirin for deep vein thrombosis (DVT) prophylaxis
Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle
Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7
Prednisone 60 mg /m2 po daily on"
481811|NCT00691808|B4|Baseline|Total|Total of all reporting groups
481812|NCT00691808|B3|Baseline|Placebo|Placebo dosing volume-matched and administered once per day
481813|NCT00691808|B2|Baseline|Low Dose|120 mg LX6171 oral suspension administered once per day
481814|NCT00691808|B1|Baseline|High Dose|240 mg LX6171 oral suspension administered once per day
481815|NCT00691808|P3|Participant Flow|Placebo|Placebo dosing volume-matched and administered once per day
481816|NCT00691808|P2|Participant Flow|Low Dose|120 mg LX6171 oral suspension administered once per day
481817|NCT00691808|P1|Participant Flow|High Dose|240 mg LX6171 oral suspension administered once per day
481818|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481819|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
481820|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481821|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481822|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
481823|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481824|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481825|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
481826|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481827|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481828|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
481829|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481833|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481834|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
481835|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481836|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481837|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
481838|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481839|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481840|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
481841|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481842|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481843|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
481844|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481845|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481846|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
481847|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481848|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
481849|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
487477|NCT00693420|E2|Reported Event|Vehicle Solution|
481853|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
481854|NCT00691808|E3|Reported Event|Placebo|Placebo dosing volume-matched and administered once per day
481855|NCT00691808|E2|Reported Event|Low Dose|120 mg LX6171 oral suspension administered once per day
481856|NCT00691808|E1|Reported Event|High Dose|240 mg LX6171 oral suspension administered once per day
481857|NCT00691938|B8|Baseline|Total|Total of all reporting groups
481858|NCT00691938|B7|Baseline|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481859|NCT00691938|B6|Baseline|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481860|NCT00691938|B5|Baseline|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481861|NCT00691938|B4|Baseline|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481862|NCT00691938|B3|Baseline|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481863|NCT00691938|B2|Baseline|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481864|NCT00691938|B1|Baseline|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481865|NCT00691938|P7|Participant Flow|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481866|NCT00691938|P6|Participant Flow|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481867|NCT00691938|P5|Participant Flow|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481868|NCT00691938|P4|Participant Flow|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481869|NCT00691938|P3|Participant Flow|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481870|NCT00691938|P2|Participant Flow|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481871|NCT00691938|P1|Participant Flow|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481872|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
481873|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
482054|NCT00685399|O6|Outcome|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
481874|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
481875|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
481888|NCT00691938|E3|Reported Event|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481889|NCT00691938|E2|Reported Event|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481876|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
481877|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
481878|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
481879|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
481880|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
481900|NCT00692003|E2|Reported Event|Zonisamide|"25-400 mg capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg; >= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)"
481881|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
481882|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.
Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
481883|NCT00691938|O1|Outcome|Phase I (Includes Levels 1-5)|
481884|NCT00691938|E7|Reported Event|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481885|NCT00691938|E6|Reported Event|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481886|NCT00691938|E5|Reported Event|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481887|NCT00691938|E4|Reported Event|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481890|NCT00691938|E1|Reported Event|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
481891|NCT00692003|B3|Baseline|Total|Total of all reporting groups
481892|NCT00692003|B2|Baseline|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)"
481893|NCT00692003|B1|Baseline|Zonisamide|"25-400 mg capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;
>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)"
481894|NCT00692003|P2|Participant Flow|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo;
>= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)"
481895|NCT00692003|P1|Participant Flow|Zonisamide|"25-400 mg capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;
>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)"
481896|NCT00692003|O2|Outcome|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)"
481897|NCT00692003|O1|Outcome|Zonisamide|"25-400 mg capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;
>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)"
481898|NCT00692003|O2|Outcome|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)"
481899|NCT00692003|O1|Outcome|Zonisamide|"25-400 mg capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;
>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)"
483503|NCT00699153|B3|Baseline|Total|Total of all reporting groups
481901|NCT00692003|E1|Reported Event|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)"
481902|NCT00684983|B3|Baseline|Total|Total of all reporting groups
481903|NCT00684983|B2|Baseline|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
481904|NCT00684983|B1|Baseline|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
481905|NCT00684983|P2|Participant Flow|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
481906|NCT00684983|P1|Participant Flow|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
481907|NCT00684983|O2|Outcome|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
481908|NCT00684983|O1|Outcome|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
481909|NCT00684983|E2|Reported Event|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
481910|NCT00684983|E1|Reported Event|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
481911|NCT00684996|B1|Baseline|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10 mg/kg or 5mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
481912|NCT00684996|P1|Participant Flow|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
481913|NCT00684996|O1|Outcome|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity un til the recommended phase II dose (RPTD) of bevacizumab is determined.
481914|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
481915|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
481916|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
481917|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
481918|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
481919|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
481920|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
481921|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
481922|NCT00684996|O1|Outcome|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10 mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
481923|NCT00684996|E1|Reported Event|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
481970|NCT00685178|B4|Baseline|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
481971|NCT00685178|B3|Baseline|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
482725|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
481924|NCT00685035|B1|Baseline|All Study Participants|"Half patients randomly assigned to HFCWC therapy first with a higher-pressure/variable frequency protocol. This entailed performing a 30 minute session with pressure of 10 and 5 minutes each at frequencies of 8,9, and 10 Hz followed by pressure of 6 and 5 minutes each at frequencies of 18, 19, and 20 Hz. This group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol after a washout period of 2 days. This entailed performing a HFCWC session using a pressure of 5 and frequency of 12 Hz for the entire 30 minute session. The other half of subjects were randomly assigned to perform the lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency after the 2 day washout period
VEST Airway Clearance System, Model 205 : Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects"
481925|NCT00685035|P2|Participant Flow|Lower Pressure/Mid-freq, Then Higher Pressure/Variable-freq|HFCWC therapy first with a lower pressure/mid-frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the higher-pressure/variable frequency HFCWC protocol (2nd Intervention).
481926|NCT00685035|P1|Participant Flow|Higher Pressure/Variable-freq, Then Lower Pressure/Mid-freq|HFCWC therapy first with a higher pressure/variable frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol (2nd Intervention).
481927|NCT00685035|O4|Outcome|Perceived Effectiveness Lower Pressure/Mid-frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."
481928|NCT00685035|O3|Outcome|Perceived Effectiveness Higher Pressure/Variable Frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."
481929|NCT00685035|O2|Outcome|Perceived Comfort Lower Pressure/Mid-frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable)."
487478|NCT00693420|E1|Reported Event|Bimatoprost 0.03% Solution|
481930|NCT00685035|O1|Outcome|Perceived Comfort Higher Pressure/Variable Frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable)."
481931|NCT00685035|O8|Outcome|"G Loss Modulus 100 Rad/Sec Lower Pressure/Mid-frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
481932|NCT00685035|O7|Outcome|"G Loss Modulus 100 Rad/Sec Higher Pressure/Variable Frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
481933|NCT00685035|O6|Outcome|"G Loss Modulus 1 Rad/Sec Lower Pressure/Mid-frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
481934|NCT00685035|O5|Outcome|"G Loss Modulus 1 Rad/Sec Higher Pressure/Variable Frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
481993|NCT00685295|P2|Participant Flow|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
481994|NCT00685295|P1|Participant Flow|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
481935|NCT00685035|O4|Outcome|G' Storage Modulus 100 Rad/Sec Lower Pressure/Mid-frequency|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
481936|NCT00685035|O3|Outcome|G' Storage Modulus 100 Rad/Sec Higher Pressure/Variable Freq|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
481937|NCT00685035|O2|Outcome|G' Storage Modulus at 1 Rad/Sec Lower Pressure/Mid-frequency|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
481954|NCT00685139|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
482218|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
481938|NCT00685035|O1|Outcome|G' Storage Modulus at 1 Rad/Sec Higher Pressure/Variable Freq|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
481939|NCT00685035|O4|Outcome|Change in FVC Pre vs Post Lower Pressure/Mid-frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
481940|NCT00685035|O3|Outcome|Change in FVC Pre vs Post Higher Pressure/Variable Frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
481941|NCT00685035|O2|Outcome|Change in FEV1 Pre vs Post Lower Pressure/Mid-frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
481942|NCT00685035|O1|Outcome|Change in FEV1 Pre vs Post Higher Pressure/Variable Frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
481943|NCT00685035|O4|Outcome|Sputum Dry Weight Lower Pressure/Mid-frequency|All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum “dry weight” was calculated after re-weighing the container.
481944|NCT00685035|O3|Outcome|Sputum Dry Weight Higher Pressure/Variable Frequency|All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum “dry weight” was calculated after re-weighing the container.
482726|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
481945|NCT00685035|O2|Outcome|Sputum Wet Weight Lower Pressure/Mid-frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet."
481946|NCT00685035|O1|Outcome|Sputum Wet Weight Higher Pressure/Variable Frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet."
481947|NCT00685035|E2|Reported Event|Higher Pressure/Variable Frequency|
481948|NCT00685035|E1|Reported Event|Lower Pressure/Mid-frequency|
481949|NCT00685139|B1|Baseline|Zonisamide 100 mg Capsules and Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg following an overnight fast.
481950|NCT00685139|P2|Participant Flow|Zonegran® 100 mg Capsules Then Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the reference formulation, Zonegran® 100 mg, after an overnight fast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the test formulation, zonisamide 100 mg, after an overnight fast.
481951|NCT00685139|P1|Participant Flow|Zonisamide 100 mg Capsules Then Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, after an overnight fast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the reference formulation, Zonegran® 100 mg, after an overnight fast.
481952|NCT00685139|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
481953|NCT00685139|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
482034|NCT00685399|P3|Participant Flow|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
481955|NCT00685139|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
481956|NCT00685139|E2|Reported Event|Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg following an overnight fast.
481957|NCT00685139|E1|Reported Event|Zonisamide 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran 100 mg following an overnight fast.
481958|NCT00685165|B1|Baseline|Primidone 50 mg Tablets and Mysoline® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast of at least 10 hours.
481959|NCT00685165|P2|Participant Flow|Mysoline® 50 mg Tablets Then Primidone 50 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the test formulation, Primidone 50 mg, after an overnight fast of at least 10 hours.
481960|NCT00685165|P1|Participant Flow|Primidone 50 mg Tablets Then Mysoline® 50 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, primidone 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours.
481961|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
481962|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
481963|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
481964|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
481965|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
481966|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
481967|NCT00685165|E2|Reported Event|Mysoline® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
481968|NCT00685165|E1|Reported Event|Primidone 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
481969|NCT00685178|B5|Baseline|Total|Total of all reporting groups
482727|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
481972|NCT00685178|B2|Baseline|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial"
481973|NCT00685178|B1|Baseline|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
481974|NCT00685178|P4|Participant Flow|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
481975|NCT00685178|P3|Participant Flow|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
481976|NCT00685178|P2|Participant Flow|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial"
481977|NCT00685178|P1|Participant Flow|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
481978|NCT00685178|O4|Outcome|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
481979|NCT00685178|O3|Outcome|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
487479|NCT00693472|B5|Baseline|Total|Total of all reporting groups
481980|NCT00685178|O2|Outcome|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial"
481981|NCT00685178|O1|Outcome|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
481982|NCT00685178|O4|Outcome|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
481983|NCT00685178|O3|Outcome|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
481984|NCT00685178|O2|Outcome|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial"
481985|NCT00685178|O1|Outcome|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
481986|NCT00685178|E4|Reported Event|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
481987|NCT00685178|E3|Reported Event|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
481988|NCT00685178|E2|Reported Event|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day."
481989|NCT00685178|E1|Reported Event|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day."
481990|NCT00685295|B3|Baseline|Total|Total of all reporting groups
481991|NCT00685295|B2|Baseline|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
481992|NCT00685295|B1|Baseline|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
481995|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|"Active Comparator Group:
Subject receives:
Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill
Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet
Lansoprazole: lansoprazole 15mg rapidly dissolving tablet
Oxycodone: Oxycodone 5/325 mg tablet"
481996|NCT00685295|O1|Outcome|Arm 1 / Fentora|"Intervention Group:
Subject receives:
placebo oral/swallowed pill
Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet
Fentanyl: Fentanyl rapid dissolving tablet 100mcg"
481997|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
481998|NCT00685295|O1|Outcome|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
481999|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
482000|NCT00685295|O1|Outcome|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
482001|NCT00685295|E2|Reported Event|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
482002|NCT00685295|E1|Reported Event|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
482003|NCT00685334|B3|Baseline|Total|Total of all reporting groups
482004|NCT00685334|B2|Baseline|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
482005|NCT00685334|B1|Baseline|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
482006|NCT00685334|P2|Participant Flow|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
482007|NCT00685334|P1|Participant Flow|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
482008|NCT00685334|O2|Outcome|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
482009|NCT00685334|O1|Outcome|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
482010|NCT00685334|O2|Outcome|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
482011|NCT00685334|O1|Outcome|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
482012|NCT00685334|E2|Reported Event|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
482013|NCT00685334|E1|Reported Event|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
482014|NCT00685373|B1|Baseline|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
482015|NCT00685373|P1|Participant Flow|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
482016|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
482017|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
482018|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
482019|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
482020|NCT00685373|E1|Reported Event|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
482021|NCT00685399|B8|Baseline|Total|Total of all reporting groups
482053|NCT00685399|O7|Outcome|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
482022|NCT00685399|B7|Baseline|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
482023|NCT00685399|B6|Baseline|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
482024|NCT00685399|B5|Baseline|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
482025|NCT00685399|B4|Baseline|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
482026|NCT00685399|B3|Baseline|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
482027|NCT00685399|B2|Baseline|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
482028|NCT00685399|B1|Baseline|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22.
482029|NCT00685399|P8|Participant Flow|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
482030|NCT00685399|P7|Participant Flow|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
482031|NCT00685399|P6|Participant Flow|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg subcutaneously (s.c.) and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
482032|NCT00685399|P5|Participant Flow|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
482033|NCT00685399|P4|Participant Flow|Cohort 4|Participants who experienced a remission of their uveitis within 8 weeks after receiving their final dose of AIN457 while enrolled in Cohorts 1, 2, 3, 5 or 6 were administered with AIN457 10 mg/kg, i.v. infusion (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
488137|NCT00708942|B5|Baseline|Arm 5: Placebo Ointment, no Illumination|
482035|NCT00685399|P2|Participant Flow|Cohort 2|Participants were administered with AIN457 (Sp2/0 or Chinese hamster ovary cell (CHO) derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed a second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
482036|NCT00685399|P1|Participant Flow|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 milligrams per kilogram (mg/kg) intravenous (i.v.) dose on Day 1 and Day 22.
482037|NCT00685399|O1|Outcome|Complete Study|All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
482038|NCT00685399|O1|Outcome|Complete Study|All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
482039|NCT00685399|O1|Outcome|Complete Study|All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
482040|NCT00685399|O1|Outcome|Complete Study|All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
482041|NCT00685399|O5|Outcome|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
482042|NCT00685399|O4|Outcome|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
482043|NCT00685399|O3|Outcome|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
482044|NCT00685399|O2|Outcome|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
482045|NCT00685399|O1|Outcome|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
482046|NCT00685399|O6|Outcome|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
482047|NCT00685399|O5|Outcome|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
482048|NCT00685399|O4|Outcome|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
482049|NCT00685399|O3|Outcome|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
482050|NCT00685399|O2|Outcome|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
482051|NCT00685399|O1|Outcome|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22.
482052|NCT00685399|O8|Outcome|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
482055|NCT00685399|O5|Outcome|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
482056|NCT00685399|O4|Outcome|Cohort 4|Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
482057|NCT00685399|O3|Outcome|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
482058|NCT00685399|O2|Outcome|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
482059|NCT00685399|O1|Outcome|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22.
482060|NCT00685399|E8|Reported Event|Cohort 4 (Extension)|Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
482061|NCT00685399|E7|Reported Event|Cohort 6 - Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
482062|NCT00685399|E6|Reported Event|Cohort 6 - Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
482063|NCT00685399|E5|Reported Event|Cohort 6 - Arm 1|Participants were administered with AIN457 300 mg s.c.and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
482064|NCT00685399|E4|Reported Event|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
482065|NCT00685399|E3|Reported Event|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
482421|NCT00696618|E1|Reported Event|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
482066|NCT00685399|E2|Reported Event|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22.
482067|NCT00685399|E1|Reported Event|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22.
482068|NCT00685477|B1|Baseline|All Study Participants|CCK-8 0.02 mg/kg over 15, 30 or 60 minutes: Drug will be given over infusions at different time periods. All participants received all treatments.
482069|NCT00685477|P6|Participant Flow|Experimental Sequence CBA|Drug given over 60 minutes infusion followed by infusion over 30 minutes, followed by infusion over 15 minutes
482070|NCT00685477|P5|Participant Flow|Experimental Sequence CAB|Drug given over 60 minutes infusion followed by infusion over 15 minutes, followed by infusion over 30 minutes
482071|NCT00685477|P4|Participant Flow|Experimental Sequence BCA|Drug given over 30 minutes infusion followed by infusion over 60 minutes, followed by infusion over 15 minutes
482072|NCT00685477|P3|Participant Flow|Experimental Sequence BAC|Drug given over 30 minutes infusion followed by infusion over 15 minutes, followed by infusion over 60 minutes
482073|NCT00685477|P2|Participant Flow|Experimental Sequence ACB|Drug given over 15 minutes infusion followed by infusion over 60 minutes, followed by infusion over 30 minutes
482074|NCT00685477|P1|Participant Flow|Experimental Sequence ABC|Drug given over 15 minutes infusion followed by infusion over 30 minutes, followed by infusion over 60 minutes
482075|NCT00685477|O3|Outcome|60 Minute Infusion|Drug given over 60 minutes
482076|NCT00685477|O2|Outcome|30 Minute Infusion|Drug given over 30 minutes
482077|NCT00685477|O1|Outcome|15 Minute Infusion|Drug given over 15 minutes
482078|NCT00685477|O3|Outcome|60 Min Infusion|Drug given over 60 minutes infusion
482079|NCT00685477|O2|Outcome|30 Min Infusion|Drug given over 30 minutes infusion
482080|NCT00685477|O1|Outcome|15min Infusion|Drug given over 15 minutes infusion
482081|NCT00685477|E1|Reported Event|All Study Participants|Drug given over 15 minute infusion to look at lowest coefficient of variation in infusion, followed by infusion over 30 minutes, followed by infusion over 60 minutes
482082|NCT00685516|B4|Baseline|Total|Total of all reporting groups
482083|NCT00685516|B3|Baseline|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
482084|NCT00685516|B2|Baseline|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: 6 cups of water daily for 2-8 weeks"
482085|NCT00685516|B1|Baseline|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
green tea: 6 cups of green tea daily for 2-8 weeks"
482086|NCT00685516|P3|Participant Flow|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
482087|NCT00685516|P2|Participant Flow|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: 6 cups of water daily for 2-8 weeks"
482088|NCT00685516|P1|Participant Flow|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
green tea: 6 cups of green tea daily for 2-8 weeks"
482089|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
482090|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: 6 cups of water daily for 2-8 weeks"
482091|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
green tea: 6 cups of green tea daily for 2-8 weeks"
482869|NCT00697801|E3|Reported Event|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
482092|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
482093|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: 6 cups of water daily for 2-8 weeks"
482094|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
green tea: 6 cups of green tea daily for 2-8 weeks"
482095|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
482096|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: 6 cups of water daily for 2-8 weeks"
482097|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
green tea: 6 cups of green tea daily for 2-8 weeks"
482098|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
482099|NCT00685516|O2|Outcome|Arm II - Water|Placebo:patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
482100|NCT00685516|O1|Outcome|Arm I - Green Tea|Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
482101|NCT00685516|E3|Reported Event|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
482102|NCT00685516|E2|Reported Event|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: 6 cups of water daily for 2-8 weeks"
482103|NCT00685516|E1|Reported Event|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
green tea: 6 cups of green tea daily for 2-8 weeks"
482104|NCT00685659|B4|Baseline|Total|Total of all reporting groups
489904|NCT00713661|E3|Reported Event|Group 3: Laparoscopic Surgery Lower|
482105|NCT00685659|B3|Baseline|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482106|NCT00685659|B2|Baseline|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482107|NCT00685659|B1|Baseline|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482108|NCT00685659|P3|Participant Flow|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482109|NCT00685659|P2|Participant Flow|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482110|NCT00685659|P1|Participant Flow|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482111|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482112|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482113|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482114|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482115|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482116|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482117|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482118|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
483166|NCT00689052|O1|Outcome|Placebo|Placebo tablets, once daily in the evening
482119|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482120|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482121|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482122|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482123|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482124|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482125|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482126|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482216|NCT00685698|P1|Participant Flow|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
489905|NCT00713661|E2|Reported Event|Group 2: Open Surgery Middle/Upper|
482127|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482128|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482129|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482130|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482131|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482132|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482133|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482134|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482135|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482136|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482137|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482138|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482139|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482140|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482728|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482141|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482142|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482143|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482144|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482145|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482146|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482147|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482148|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482149|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
489906|NCT00713661|E1|Reported Event|Group 1: Open Surgery Lower|
482150|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482151|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482152|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482153|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482154|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482155|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482156|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482157|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482158|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482159|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482160|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482161|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482162|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482240|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482163|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482164|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482165|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482166|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482167|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482168|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482169|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482170|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482171|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482217|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482422|NCT00696696|B1|Baseline|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
482172|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482173|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482174|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482175|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482176|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482177|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482178|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482179|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482180|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482181|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482182|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482183|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482184|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482185|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482186|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482187|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482188|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482189|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482190|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482191|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482192|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482193|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482194|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
490892|NCT00706628|B5|Baseline|Total|Total of all reporting groups
482195|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482196|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482197|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482198|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482199|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482200|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482201|NCT00685659|E3|Reported Event|TMAC Plus|"Adaptive telephone-based counseling, plus incentives
Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
482202|NCT00685659|E2|Reported Event|TMAC|"Adaptive telephone-based counseling
Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
482203|NCT00685659|E1|Reported Event|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
482204|NCT00685685|B1|Baseline|Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
482205|NCT00685685|P2|Participant Flow|Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Mevacor® 40 mg after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours.
482206|NCT00685685|P1|Participant Flow|Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours.
483167|NCT00689052|E2|Reported Event|Pramipexole|
482207|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482208|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482209|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482210|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482211|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482212|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482213|NCT00685685|E2|Reported Event|Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
482214|NCT00685685|E1|Reported Event|Lovastatin 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
482215|NCT00685698|B1|Baseline|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482424|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
482219|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482220|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482221|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482222|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482223|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482224|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482225|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to EOT/ET Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482226|NCT00685698|O2|Outcome|Nemonoxacin (at EOT/ET Visit, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482227|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482228|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to EOT/ET Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482229|NCT00685698|O2|Outcome|Nemonoxacin (at EOT/ET Visit, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482230|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482231|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482232|NCT00685698|O2|Outcome|Nemonoxacin (at Test of Cure Visit, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482233|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482234|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482235|NCT00685698|O2|Outcome|Nemonoxacin (at Test of Cure Visit, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482236|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482237|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482238|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482239|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482241|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482242|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482243|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482244|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482245|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482246|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482247|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482248|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482249|NCT00685698|E1|Reported Event|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
TG-873870 (Nemonoxacin): 750 mg"
482250|NCT00685763|B1|Baseline|Proton Radiation and Chemotherapy|Unresectable Carcinoma of the Pancreas
482251|NCT00685763|P1|Participant Flow|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination
Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.
Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.
Consolidation Chemotherapy starting 4 weeks after the completion of radiation
Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.
Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)
Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .
Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
482275|NCT00685945|P1|Participant Flow|All Participants|24 subjects received a bradykinin infusion and then a bradykinin + L-NMMA infusion. Subjects were then randomized to receive either isosorbide (N=12) or sildenafil (N=12). The infusion of bradykinin + L-NMMA was then repeated.
482423|NCT00696696|P1|Participant Flow|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
482252|NCT00685763|O1|Outcome|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination
Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.
Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.
Consolidation Chemotherapy starting 4 weeks after the completion of radiation
Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.
Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)
Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .
Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
482253|NCT00685763|E1|Reported Event|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination
Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.
Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.
Consolidation Chemotherapy starting 4 weeks after the completion of radiation
Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.
Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)
Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .
Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
482254|NCT00685802|B1|Baseline|Cilostazol 50 mg Tablets and Pletal® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either Cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
482255|NCT00685802|P2|Participant Flow|Pletal® 50 mg Tablets Then Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received two tablets of the test formulation, Cilostazol 50 mg, after an overnight fast of at least 10 hours.
482256|NCT00685802|P1|Participant Flow|Cilostazol 50 mg Tablets Then Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of the test formulation, Cilostazol 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received two tablets of the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours.
482257|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482258|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482259|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482296|NCT00692185|E2|Reported Event|Placebo|Participants will take matched placebo for 16 weeks.
482454|NCT00696774|P2|Participant Flow|Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482260|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482261|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482262|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
482263|NCT00685802|E2|Reported Event|Pletal® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
482264|NCT00685802|E1|Reported Event|Cilostazol 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
482265|NCT00685880|B3|Baseline|Total|Total of all reporting groups
482266|NCT00685880|B2|Baseline|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
482267|NCT00685880|B1|Baseline|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
482268|NCT00685880|P2|Participant Flow|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
482269|NCT00685880|P1|Participant Flow|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
482270|NCT00685880|O2|Outcome|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
482271|NCT00685880|O1|Outcome|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
482272|NCT00685880|E2|Reported Event|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
482273|NCT00685880|E1|Reported Event|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
482274|NCT00685945|B1|Baseline|All Participants|Subjects characteristics for all 24 participants
482276|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve (of the twenty-four) subjects received sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
482277|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Twelve (of the twenty-four)subjects received isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
482278|NCT00685945|O2|Outcome|L-NMMA + Control|Subjects received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
482279|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
482280|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve (of the twenty-four) subjects received sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
482281|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Twelve (of the twenty-four)subjects received isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
482282|NCT00685945|O2|Outcome|L-NMMA + Control|Subjects received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
482283|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
482284|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve of the twenty-four subjects were randomized to sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
482285|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Eleven of the twenty-four subjects were randomized to isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
482286|NCT00685945|O2|Outcome|L-NMMA + Control|After the intial bradykinin infusion subjects then received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
482287|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
482288|NCT00685945|E1|Reported Event|All Participants|Subjects characteristics for all 24 participants
482289|NCT00692185|B3|Baseline|Total|Total of all reporting groups
482290|NCT00692185|B2|Baseline|Placebo|Participants will take matched placebo for 16 weeks.
482291|NCT00692185|B1|Baseline|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
482292|NCT00692185|P2|Participant Flow|Placebo|Participants will take matched placebo for 16 weeks.
482293|NCT00692185|P1|Participant Flow|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
482294|NCT00692185|O2|Outcome|Placebo|Participants will take matched placebo for 16 weeks.
482295|NCT00692185|O1|Outcome|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
482297|NCT00692185|E1|Reported Event|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
482298|NCT00692198|B3|Baseline|Total|Total of all reporting groups
482299|NCT00692198|B2|Baseline|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest).
482300|NCT00692198|B1|Baseline|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482301|NCT00692198|P2|Participant Flow|No Supplemental Oxygen Therapy (No LTOT)|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482302|NCT00692198|P1|Participant Flow|Supplemental Oxygen Therapy (LTOT)|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482303|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482361|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482304|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482305|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482306|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482307|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482308|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482309|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482310|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482311|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482312|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482313|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482314|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482315|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482316|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482317|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482411|NCT00696618|O2|Outcome|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
482412|NCT00696618|O1|Outcome|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
482413|NCT00696618|O3|Outcome|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
482318|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482319|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482320|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482321|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482322|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482323|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482324|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482325|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482326|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482327|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482328|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482329|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
482330|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.
Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
482331|NCT00692198|E3|Reported Event|No Supplemental Oxygen|Participants in the No supplemental oxygen who did not receive home oxygen during their participation in the trial.
482332|NCT00692198|E2|Reported Event|Patients Crossing Over to Supplemental Oxygen Therapy|Participants in the No supplemental oxygen therapy group who receive supplemental oxygen therapy during their participation in the trial due to prescription of supplemental oxygen outside the trial or development of severe resting or exercise hypoxemia
482414|NCT00696618|O2|Outcome|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
482333|NCT00692198|E1|Reported Event|Supplemental Oxygen Therapy|Participants will receive treatment with supplemental oxygen therapy. Supplemental oxygen therapy: oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep.
482334|NCT00692211|B3|Baseline|Total|Total of all reporting groups
482335|NCT00692211|B2|Baseline|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests
Fecal occult blood test: Stool blood test"
482336|NCT00692211|B1|Baseline|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests
Fecal immunochemical testing: Stool blood test"
482337|NCT00692211|P2|Participant Flow|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests
Fecal occult blood test: Stool blood test"
482338|NCT00692211|P1|Participant Flow|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests
Fecal immunochemical testing: Stool blood test"
482339|NCT00692211|O2|Outcome|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests
Fecal occult blood test: Stool blood test"
482340|NCT00692211|O1|Outcome|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests
Fecal immunochemical testing: Stool blood test"
482341|NCT00692211|E2|Reported Event|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests
Fecal occult blood test: Stool blood test"
482342|NCT00692211|E1|Reported Event|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests
Fecal immunochemical testing: Stool blood test"
482343|NCT00692237|B3|Baseline|Total|Total of all reporting groups
482344|NCT00692237|B2|Baseline|Placebo|Placebo 100 mg/day (50 + 25 + 25)
482345|NCT00692237|B1|Baseline|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
482346|NCT00692237|P2|Participant Flow|Placebo|Placebo 100 mg/day (50 + 25 + 25)
482347|NCT00692237|P1|Participant Flow|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
482348|NCT00692237|O2|Outcome|Placebo|Patients randomized to receive placebo were instructed to take 3 capsules per day (1 at 8.00 a.m. + 1 at 4.00 p.m. + 1 at 10.00 p.m.) that were identical-looking to sildenafil capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
482349|NCT00692237|O1|Outcome|Sildenafil|Patients randomized to receive sildenafil were instructed to take 3 capsules per day (25 mg at 8.00 a.m. + 25 mg at 4.00 p.m. + 50 mg at 10.00 p.m.) that were identical-looking to placebo capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
482350|NCT00692237|O2|Outcome|Placebo|Patients randomized to receive placebo were instructed to take 3 capsules per day (1 at 8.00 a.m. + 1 at 4.00 p.m. + 1 at 10.00 p.m.) that were identical-looking to sildenafil capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
482402|NCT00692341|E1|Reported Event|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482403|NCT00696618|B4|Baseline|Total|Total of all reporting groups
482351|NCT00692237|O1|Outcome|Sildenafil|Patients randomized to receive sildenafil were instructed to take 3 capsules per day (25 mg at 8.00 a.m. + 25 mg at 4.00 p.m. + 50 mg at 10.00 p.m.) that were identical-looking to placebo capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
482352|NCT00692237|E2|Reported Event|Placebo|Placebo 100 mg/day (50 + 25 + 25)
482353|NCT00692237|E1|Reported Event|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
482354|NCT00692341|B4|Baseline|Total|Total of all reporting groups
482355|NCT00692341|B3|Baseline|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482356|NCT00692341|B2|Baseline|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482357|NCT00692341|B1|Baseline|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482358|NCT00692341|P3|Participant Flow|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482359|NCT00692341|P2|Participant Flow|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482360|NCT00692341|P1|Participant Flow|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482415|NCT00696618|O1|Outcome|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
482416|NCT00696618|O3|Outcome|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
482362|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482363|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482364|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482365|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482366|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482367|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482368|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482369|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482451|NCT00696774|B2|Baseline|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482452|NCT00696774|B1|Baseline|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482370|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482371|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482372|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482373|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482374|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482375|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482376|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482377|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482378|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482417|NCT00696618|O2|Outcome|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
482379|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482380|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482381|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482382|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482383|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482384|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482385|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482453|NCT00696774|P3|Participant Flow|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
482386|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482387|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482388|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482389|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482390|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482391|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482392|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482393|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482394|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482418|NCT00696618|O1|Outcome|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
482419|NCT00696618|E3|Reported Event|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
482420|NCT00696618|E2|Reported Event|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
482395|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482396|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482397|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482398|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482399|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
482400|NCT00692341|E3|Reported Event|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
482401|NCT00692341|E2|Reported Event|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
482404|NCT00696618|B3|Baseline|Fleet/Tap Water/Normosol-R|"Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)
Fleet Enema: hyper-osmolar preparation
tap water enema: hypo-osmolar preparation
Normosol-R enema: iso-osmolar preparation"
482405|NCT00696618|B2|Baseline|Normosol-R/Fleet/Tap Water|"Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)
Fleet Enema: hyper-osmolar preparation
tap water enema: hypo-osmolar preparation
Normosol-R enema: iso-osmolar preparation"
482406|NCT00696618|B1|Baseline|Tap Water/Normosol-R/Fleet|"Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)
Fleet Enema: hyper-osmolar preparation
tap water enema: hypo-osmolar preparation
Normosol-R enema: iso-osmolar preparation"
482407|NCT00696618|P3|Participant Flow|Fleet/Tap Water/Normosol-R|"Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)
Fleet Enema: hyper-osmolar preparation
tap water enema: hypo-osmolar preparation
Normosol-R enema: iso-osmolar preparation"
482408|NCT00696618|P2|Participant Flow|Normosol-R/Fleet/Tap Water|"Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)
Fleet Enema: hyper-osmolar preparation
tap water enema: hypo-osmolar preparation
Normosol-R enema: iso-osmolar preparation"
482409|NCT00696618|P1|Participant Flow|Tap Water/Normosol-R/Fleet|"Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)
Fleet Enema: hyper-osmolar preparation
tap water enema: hypo-osmolar preparation
Normosol-R enema: iso-osmolar preparation"
482410|NCT00696618|O3|Outcome|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
482425|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
482426|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
482427|NCT00696696|E1|Reported Event|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
482428|NCT00696761|B5|Baseline|Total|Total of all reporting groups
482429|NCT00696761|B4|Baseline|group2|"BOOI≥ 20, BCI<100
alfuzosin : 10mg, once daily, 12months"
482430|NCT00696761|B3|Baseline|group1|"BOOI≥ 20, BCI≥ 100
alfuzosin : 10mg, once daily, 12months"
482431|NCT00696761|B2|Baseline|Group 4|"BOOI<20, BCI<100
alfuzosin : 10mg, once daily, 12 months"
482432|NCT00696761|B1|Baseline|Group 3|"BOOI<20, BCI≥ 100)
alfuzosin : 10mg, once daily, 12months"
482433|NCT00696761|P4|Participant Flow|BOOI<20, BCI< 100|"BOOI<20, BCI<100
alfuzosin : 10mg, once daily, 12 months"
482434|NCT00696761|P3|Participant Flow|BOOI<20, BCI≥ 100|"BOOI<20, BCI≥ 100)
alfuzosin : 10mg, once daily, 12months"
482435|NCT00696761|P2|Participant Flow|BOOI≥20, BCI< 100|"BOOI≥ 20, BCI<100
alfuzosin : 10mg, once daily, 12months"
482436|NCT00696761|P1|Participant Flow|BOOI≥20, BCI≥ 100|"Bladder outlet obstruction index(BOOI)≥ 20, bladder contractility index (BCI)≥ 100
alfuzosin : 10mg, once daily, 12months"
482437|NCT00696761|O4|Outcome|group2|"BOOI≥ 20, BCI<100
alfuzosin : 10mg, once daily, 12months"
482438|NCT00696761|O3|Outcome|group1|"BOOI≥ 20, BCI≥ 100
alfuzosin : 10mg, once daily, 12months"
482439|NCT00696761|O2|Outcome|Group 4|"BOOI<20, BCI<100
alfuzosin : 10mg, once daily, 12 months"
482440|NCT00696761|O1|Outcome|Group 3|"BOOI<20, BCI≥ 100)
alfuzosin : 10mg, once daily, 12months"
482441|NCT00696761|O4|Outcome|BOOI<20, BCI<100|"BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12 months"
482442|NCT00696761|O3|Outcome|BOOI<20, BCI≥ 100|"BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months"
482443|NCT00696761|O2|Outcome|BOOI≥ 20, BCI<100|"BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months"
482444|NCT00696761|O1|Outcome|BOOI≥ 20, BCI≥100|"Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months"
482445|NCT00696761|E4|Reported Event|group2|"BOOI≥ 20, BCI<100
alfuzosin : 10mg, once daily, 12months"
482446|NCT00696761|E3|Reported Event|group1|"BOOI≥ 20, BCI≥ 100
alfuzosin : 10mg, once daily, 12months"
482447|NCT00696761|E2|Reported Event|Group 4|"BOOI<20, BCI<100
alfuzosin : 10mg, once daily, 12 months"
482448|NCT00696761|E1|Reported Event|Group 3|"BOOI<20, BCI≥ 100)
alfuzosin : 10mg, once daily, 12months"
482449|NCT00696774|B4|Baseline|Total|Total of all reporting groups
482450|NCT00696774|B3|Baseline|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
482455|NCT00696774|P1|Participant Flow|Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482456|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482457|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482458|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482459|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482460|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482461|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482462|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482463|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482464|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482465|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482466|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482467|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482468|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482469|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482470|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482471|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482472|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482473|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482474|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482475|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482476|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482477|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482478|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482479|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482480|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482481|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482482|NCT00696774|O1|Outcome|Duloxetine|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks. Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.
482483|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482484|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482485|NCT00696774|E3|Reported Event|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
482486|NCT00696774|E2|Reported Event|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
482487|NCT00696774|E1|Reported Event|Duloxetine Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
482488|NCT00696787|B4|Baseline|Total|Total of all reporting groups
482489|NCT00696787|B3|Baseline|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
482490|NCT00696787|B2|Baseline|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
482491|NCT00696787|B1|Baseline|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
482492|NCT00696787|P3|Participant Flow|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
482493|NCT00696787|P2|Participant Flow|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
482494|NCT00696787|P1|Participant Flow|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
482495|NCT00696787|O3|Outcome|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
482496|NCT00696787|O2|Outcome|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
482497|NCT00696787|O1|Outcome|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
482498|NCT00696787|O3|Outcome|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
482499|NCT00696787|O2|Outcome|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
482500|NCT00696787|O1|Outcome|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
482501|NCT00696787|E3|Reported Event|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
482502|NCT00696787|E2|Reported Event|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
482503|NCT00696787|E1|Reported Event|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
482504|NCT00696800|B3|Baseline|Total|Total of all reporting groups
482632|NCT00697073|E1|Reported Event|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)
Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
482745|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
482505|NCT00696800|B2|Baseline|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482506|NCT00696800|B1|Baseline|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482507|NCT00696800|P2|Participant Flow|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482508|NCT00696800|P1|Participant Flow|150 µg Corifollitropin Alfa|Participants received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human Chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses.
482509|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482510|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482511|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482866|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
482512|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482513|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482514|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482515|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482516|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482662|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
491162|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
482517|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482518|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482519|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482520|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482521|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482522|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482523|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
483168|NCT00689052|E1|Reported Event|Placebo|
482524|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482525|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482526|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482527|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482528|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482663|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482664|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482529|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482530|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482531|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482532|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482533|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482534|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482535|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482536|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482537|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482538|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482539|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482540|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482665|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482746|NCT00697541|O1|Outcome|Treatment A - COL-118 Facial Gel + Saline Drops|COL-118 facial gel + saline drops
482541|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482542|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482543|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482544|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482545|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482546|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482547|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482548|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482549|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482550|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482551|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482552|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482666|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482747|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
482553|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482554|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482555|NCT00696800|E2|Reported Event|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482556|NCT00696800|E1|Reported Event|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
482557|NCT00696878|B1|Baseline|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482558|NCT00696878|P1|Participant Flow|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer (FTET) cycles (up to 3 after each COS cycle) could occur.
482684|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
483169|NCT00689091|B3|Baseline|Total|Total of all reporting groups
482559|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482560|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482561|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482562|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482563|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482667|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482564|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482565|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482566|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482567|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482568|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482685|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482686|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482569|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482570|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482571|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482572|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482573|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482574|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482575|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482576|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482577|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482578|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482579|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482580|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482581|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482582|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482583|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482584|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482585|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482586|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482587|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482588|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482589|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482590|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482591|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482592|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482593|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482594|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482595|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482596|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482597|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482598|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482599|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482600|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482601|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482602|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482603|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482604|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482605|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482606|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482607|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482608|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482609|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482610|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482611|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482612|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482613|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482614|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482615|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482616|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482617|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482618|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482619|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482620|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482621|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482622|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482623|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482624|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482625|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482626|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482627|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482628|NCT00696878|E1|Reported Event|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
482629|NCT00697073|B1|Baseline|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)
Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
482630|NCT00697073|P1|Participant Flow|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)
Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
482631|NCT00697073|O1|Outcome|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)
Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
482633|NCT00697112|B1|Baseline|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482634|NCT00697112|P1|Participant Flow|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482635|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482636|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482637|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482638|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482639|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482640|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482641|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482642|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482643|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482644|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482645|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
491163|NCT00706901|O2|Outcome|Arm 2 IHMD|In Home Messaging Device
482646|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482647|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482648|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482649|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482650|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482651|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482652|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482653|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482654|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482655|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482656|NCT00697112|E1|Reported Event|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
482657|NCT00697190|B1|Baseline|All Completed Subjects|All subjects that completed the study were analyzed. One subject from the senofilcon A/ galyfilcon A arm dropped from the study between the first and second intervention. The subject moved out of town.
482658|NCT00697190|P2|Participant Flow|Galyfilcon A/Senofilcon A|galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.
482659|NCT00697190|P1|Participant Flow|Senofilcon A/Galyfilcon A|senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.
482660|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482661|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
491164|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
482668|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482669|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482670|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482671|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482672|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482673|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482674|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482675|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482676|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482677|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482678|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482679|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482680|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482681|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482682|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482683|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482724|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482687|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482688|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
482689|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
482690|NCT00697190|E2|Reported Event|Galyfilcon A|galyfilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
482691|NCT00697190|E1|Reported Event|Senofilcon A|senofilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
482692|NCT00697255|B3|Baseline|Total|Total of all reporting groups
482693|NCT00697255|B2|Baseline|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482694|NCT00697255|B1|Baseline|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482695|NCT00697255|P2|Participant Flow|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482696|NCT00697255|P1|Participant Flow|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482697|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482698|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482699|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482700|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482701|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482702|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482703|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482704|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482705|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482706|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482707|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482744|NCT00697541|P1|Participant Flow|Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops|"One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.
First intervention (1 day), washout (1 day), Second intervention (1 day)"
482708|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482709|NCT00697255|E2|Reported Event|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482710|NCT00697255|E1|Reported Event|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
482711|NCT00697515|B1|Baseline|Entire Study Population|
482712|NCT00697515|P2|Participant Flow|Placebo First|Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
482713|NCT00697515|P1|Participant Flow|SPD489 First|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.
482714|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
482715|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482716|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482717|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482718|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482719|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482720|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482721|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482722|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482723|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
482729|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482730|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
482731|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482732|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
482733|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482734|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
482735|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482736|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
482737|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
482738|NCT00697515|E2|Reported Event|Placebo|Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
482739|NCT00697515|E1|Reported Event|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.
482740|NCT00697541|B3|Baseline|Total|Total of all reporting groups
482741|NCT00697541|B2|Baseline|Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops|"One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically
First intervention (1 day), washout (1 day), Second intervention (1 day)"
482742|NCT00697541|B1|Baseline|Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops|"One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.
First intervention (1 day), washout (1 day), Second intervention (1 day)"
482743|NCT00697541|P2|Participant Flow|Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops|"One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically
First intervention (1 day), washout (1 day), Second intervention (1 day)"
482748|NCT00697541|O1|Outcome|Treatment A - COL-118 Gel + Saline Drops|COL-118 gel + saline drops
482749|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
482750|NCT00697541|O1|Outcome|Treatment A - COL-118 Facial Gel + Saline Drops|COL-118 facial gel + saline drops
482751|NCT00697541|E2|Reported Event|Treatment B|Vehicle gel + brimonidine drops
482752|NCT00697541|E1|Reported Event|Treatment A|COL-118 gel + saline drops
482753|NCT00697593|B1|Baseline|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482754|NCT00697593|P1|Participant Flow|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482755|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482756|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482757|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482758|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482759|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482760|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482761|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482762|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482763|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482764|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482765|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482766|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
483504|NCT00699153|B2|Baseline|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
482767|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482768|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482769|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482770|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482771|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482772|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482773|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482774|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482775|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482776|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482777|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482844|NCT00697788|O1|Outcome|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|
491165|NCT00706901|E3|Reported Event|Arm 3 TCC|Treatment Control Condition
482778|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482779|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482780|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482781|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482782|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482783|NCT00697593|E1|Reported Event|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
482784|NCT00697619|B3|Baseline|Total|Total of all reporting groups
482785|NCT00697619|B2|Baseline|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
482786|NCT00697619|B1|Baseline|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
482787|NCT00697619|P2|Participant Flow|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
482788|NCT00697619|P1|Participant Flow|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
482789|NCT00697619|O2|Outcome|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
482790|NCT00697619|O1|Outcome|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
482791|NCT00697619|E2|Reported Event|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
482792|NCT00697619|E1|Reported Event|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
482793|NCT00697697|B3|Baseline|Total|Total of all reporting groups
482794|NCT00697697|B2|Baseline|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
482795|NCT00697697|B1|Baseline|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
482796|NCT00697697|P2|Participant Flow|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
482797|NCT00697697|P1|Participant Flow|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
482798|NCT00697697|O2|Outcome|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
482799|NCT00697697|O1|Outcome|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
482800|NCT00697697|O2|Outcome|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
482801|NCT00697697|O1|Outcome|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
482802|NCT00697697|E2|Reported Event|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
482803|NCT00697697|E1|Reported Event|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
482804|NCT00697788|B1|Baseline|Ascending Dose Study|"Ascending doses of dexmedetomidine (as per protocol)
Dexmedetomidine: Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5."
482805|NCT00697788|P8|Participant Flow|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes. This group is a subset of cohort 7.
482806|NCT00697788|P7|Participant Flow|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes. This group is a subset of cohort 6.
482807|NCT00697788|P6|Participant Flow|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes. This group is a subset of cohort 5.
482808|NCT00697788|P5|Participant Flow|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes. This group is a subset of cohort 4.
482809|NCT00697788|P4|Participant Flow|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes. This group is a subset of cohort 3.
482810|NCT00697788|P3|Participant Flow|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|This group received the bolus dose, followed by dexmedetomidine infusion for 15 minutes at 0.7 mcg/kg/hr, followed by 1.0 mcg/kg/hr infusion for 15 minutes. This is a subset of cohort 2.
491166|NCT00706901|E2|Reported Event|Arm 2 IHMD|In Home Messaging Device
482811|NCT00697788|P2|Participant Flow|Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion|This group received the bolus dose and a continuous infusion for 15 minutes of 0.7 mcg/kg/hr of dexmedetomidine. This group is a subset of Cohort 1 that continued in this ascending dose study.
482812|NCT00697788|P1|Participant Flow|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|All participants received a dexmedetomidine bolus of 1.0 micrograms (mcg) per kilogram over 10 minutes.
482813|NCT00697788|O8|Outcome|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes. This group is a subset of cohort 7.
482814|NCT00697788|O7|Outcome|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes. This group is a subset of cohort 6.
482815|NCT00697788|O6|Outcome|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes. This group is a subset of cohort 5.
482816|NCT00697788|O5|Outcome|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes. This group is a subset of cohort 4.
482817|NCT00697788|O4|Outcome|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes. This group is a subset of cohort 3.
482818|NCT00697788|O3|Outcome|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|This group received the bolus dose, followed by dexmedetomidine infusion for 15 minutes at 0.7 mcg/kg/hr, followed by 1.0 mcg/kg/hr infusion for 15 minutes. This is a subset of cohort 2.
482819|NCT00697788|O2|Outcome|Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion|This group received the bolus dexmedetomidine and a continuous infusion for 15 minutes of 0.7 mcg/kg/hr of dexmedetomidine. This group is a subset of Cohort 1 that continued in this ascending dose study.
482820|NCT00697788|O1|Outcome|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|All participants received a dexmedetomidine bolus of 1.0 micrograms (mcg) per kilogram over 10 minutes.
482821|NCT00697788|O8|Outcome|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes. This group is a subset of cohort 7.
482822|NCT00697788|O7|Outcome|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes. This group is a subset of cohort 6.
482867|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
482868|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
482823|NCT00697788|O6|Outcome|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes. This group is a subset of cohort 5.
482824|NCT00697788|O5|Outcome|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes. This group is a subset of cohort 4.
482825|NCT00697788|O4|Outcome|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes. This group is a subset of cohort 3.
482826|NCT00697788|O3|Outcome|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|This group received the bolus dose, followed by dexmedetomidine infusion for 15 minutes at 0.7 mcg/kg/hr, followed by 1.0 mcg/kg/hr infusion for 15 minutes. This is a subset of cohort 2.
482827|NCT00697788|O2|Outcome|Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion|This group received the bolus dexmedetomidine and a continuous infusion for 15 minutes of 0.7 mcg/kg/hr of dexmedetomidine. This group is a subset of Cohort 1 that continued in this ascending dose study.
482828|NCT00697788|O1|Outcome|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|All participants received a dexmedetomidine bolus of 1.0 micrograms (mcg) per kilogram over 10 minutes.
482829|NCT00697788|O8|Outcome|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|
482830|NCT00697788|O7|Outcome|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|
482831|NCT00697788|O6|Outcome|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|
482832|NCT00697788|O5|Outcome|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|
482833|NCT00697788|O4|Outcome|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|
482834|NCT00697788|O3|Outcome|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|
482835|NCT00697788|O2|Outcome|Cohort 2: Dexmedetomidine Bolus + 0.7 mcg/kg/hr Infusion|
482836|NCT00697788|O1|Outcome|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|"Ascending doses of dexmedetomidine (as per protocol)
Dexmedetomidine: Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5."
482837|NCT00697788|O8|Outcome|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|
482838|NCT00697788|O7|Outcome|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|
482839|NCT00697788|O6|Outcome|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|
482840|NCT00697788|O5|Outcome|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|
482841|NCT00697788|O4|Outcome|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|
482842|NCT00697788|O3|Outcome|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|
482843|NCT00697788|O2|Outcome|Cohort 2: Dexmedetomidine Bolus + 0.7 mcg/kg/hr Infusion|
482845|NCT00697788|E8|Reported Event|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes
482846|NCT00697788|E7|Reported Event|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes
482847|NCT00697788|E6|Reported Event|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes
482848|NCT00697788|E5|Reported Event|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes
482849|NCT00697788|E4|Reported Event|Cohort 4: Dexmedetomidine 1.3 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr
482850|NCT00697788|E3|Reported Event|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes
482851|NCT00697788|E2|Reported Event|Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes
482852|NCT00697788|E1|Reported Event|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|All participants received a dexmedetomidine bolus dose of 1 microgram/kilogram over 10 minutes IV
482853|NCT00697801|B4|Baseline|Total|Total of all reporting groups
482854|NCT00697801|B3|Baseline|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
482855|NCT00697801|B2|Baseline|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
482856|NCT00697801|B1|Baseline|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
482857|NCT00697801|P3|Participant Flow|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
482858|NCT00697801|P2|Participant Flow|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
482859|NCT00697801|P1|Participant Flow|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
482860|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
482861|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
482862|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
482863|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
482864|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
482865|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
482870|NCT00697801|E2|Reported Event|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
482871|NCT00697801|E1|Reported Event|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
482872|NCT00697827|B3|Baseline|Total|Total of all reporting groups
482873|NCT00697827|B2|Baseline|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
482874|NCT00697827|B1|Baseline|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
482875|NCT00697827|P2|Participant Flow|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
482876|NCT00697827|P1|Participant Flow|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
494357|NCT00720096|B3|Baseline|Total|Total of all reporting groups
482877|NCT00697827|O2|Outcome|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
482878|NCT00697827|O1|Outcome|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
482879|NCT00697827|O2|Outcome|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
482880|NCT00697827|O1|Outcome|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
482881|NCT00697827|E2|Reported Event|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
482882|NCT00697827|E1|Reported Event|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
482883|NCT00698009|B1|Baseline|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
482999|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
483160|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
482884|NCT00698009|P1|Participant Flow|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
482885|NCT00698009|O1|Outcome|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
482886|NCT00698009|E1|Reported Event|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
482887|NCT00698022|B4|Baseline|Total|Total of all reporting groups
482888|NCT00698022|B3|Baseline|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
482889|NCT00698022|B2|Baseline|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
482890|NCT00698022|B1|Baseline|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
482891|NCT00698022|P3|Participant Flow|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
482892|NCT00698022|P2|Participant Flow|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
482893|NCT00698022|P1|Participant Flow|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
482894|NCT00698022|O3|Outcome|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
482895|NCT00698022|O2|Outcome|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
482896|NCT00698022|O1|Outcome|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
482897|NCT00698022|E3|Reported Event|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
482898|NCT00698022|E2|Reported Event|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
482899|NCT00698022|E1|Reported Event|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
482900|NCT00698035|B3|Baseline|Total|Total of all reporting groups
482901|NCT00698035|B2|Baseline|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
482902|NCT00698035|B1|Baseline|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
482903|NCT00698035|P2|Participant Flow|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
482904|NCT00698035|P1|Participant Flow|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
482905|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
482906|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
482907|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
482908|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
482909|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
482910|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
482911|NCT00698035|O1|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
482912|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
482913|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
482914|NCT00698035|O2|Outcome|E2 by RIA|Additional measurement of baseline and week 4 E2 by RIA
482915|NCT00698035|O1|Outcome|E2 by LC/MS|A commercially available ultrasensitive E2 level was measured at baseline and 4 weeks (Quest Diagnostics, liquid chromatography tandem mass spectrometry (LC/MS, PM range <10 pg/ml)
482916|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
482917|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
482918|NCT00698035|E2|Reported Event|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
482919|NCT00698035|E1|Reported Event|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
482920|NCT00698139|B4|Baseline|Total|Total of all reporting groups
482921|NCT00698139|B3|Baseline|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
483161|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
482922|NCT00698139|B2|Baseline|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
482923|NCT00698139|B1|Baseline|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
482924|NCT00698139|P3|Participant Flow|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
482933|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
482988|NCT00698646|B3|Baseline|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
482925|NCT00698139|P2|Participant Flow|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
482926|NCT00698139|P1|Participant Flow|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
482927|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
482928|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
483000|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
483162|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
483163|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
482929|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
482930|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
482931|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
482932|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
482954|NCT00698451|E1|Reported Event|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
483075|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
482934|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
482935|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
482936|NCT00698139|E3|Reported Event|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
482937|NCT00698139|E2|Reported Event|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
482938|NCT00698139|E1|Reported Event|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
482939|NCT00698204|B3|Baseline|Total|Total of all reporting groups
482940|NCT00698204|B2|Baseline|II- Placebo|placebo: Subject was randomized to take placebo each day that radiation therapy was given.
482941|NCT00698204|B1|Baseline|I- Celecoxib|celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given.
482942|NCT00698204|P2|Participant Flow|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
482943|NCT00698204|P1|Participant Flow|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
482944|NCT00698204|O2|Outcome|II- Placebo|placebo: Subject was randomized to take placebo each day that radiation therapy was given.
482945|NCT00698204|O1|Outcome|I- Celecoxib|celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given.
482946|NCT00698204|O2|Outcome|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
482947|NCT00698204|O1|Outcome|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
482948|NCT00698204|E2|Reported Event|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
482949|NCT00698204|E1|Reported Event|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
482950|NCT00698451|B1|Baseline|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
482951|NCT00698451|P1|Participant Flow|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
482952|NCT00698451|O1|Outcome|DOXIL/CARBOPLATIN/BEVACIZUMAB|doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
482953|NCT00698451|O1|Outcome|DOXIL/CARBOPLATIN/BEVACIZUMAB|doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
482955|NCT00698516|B1|Baseline|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
482956|NCT00698516|P1|Participant Flow|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
482957|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
482958|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
482959|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
483001|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
483628|NCT00699400|O3|Outcome|All Participants|
482960|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
482961|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
482962|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
482963|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensistive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
482964|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
482965|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
482986|NCT00698581|E1|Reported Event|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
482987|NCT00698646|B4|Baseline|Total|Total of all reporting groups
483076|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
496037|NCT00724984|B4|Baseline|Cohort 4(60 mg/m2,7days/wk)/Phase 1|
482966|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
482967|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
482968|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
482969|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
483002|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
483164|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
482970|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
482971|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
482972|NCT00698516|E1|Reported Event|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 mg/m^2/day for 5 consecutive days (Days 1 to 5) and IV bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GSK’s study physician was needed for subjects who required treatment beyond 8 cycles.
482973|NCT00698581|B3|Baseline|Total Title|
482974|NCT00698581|B2|Baseline|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
482975|NCT00698581|B1|Baseline|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
482976|NCT00698581|P2|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
482977|NCT00698581|P1|Participant Flow|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
482978|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
482979|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
482980|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
482981|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
482982|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
482983|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
482984|NCT00698581|O1|Outcome|Efficacy Analysis Set (BRV 50 mg/Day Treated Subjects)|The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
482985|NCT00698581|E2|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
482989|NCT00698646|B2|Baseline|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
482990|NCT00698646|B1|Baseline|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
482991|NCT00698646|P3|Participant Flow|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
482992|NCT00698646|P2|Participant Flow|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
482993|NCT00698646|P1|Participant Flow|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
482994|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
482995|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
482996|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
482997|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
482998|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
483165|NCT00689052|O2|Outcome|Pramipexole|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
483003|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
483004|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
483005|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
483006|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
483007|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
483008|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
483009|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
483010|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
483011|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
483012|NCT00698646|E3|Reported Event|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
483013|NCT00698646|E2|Reported Event|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
483014|NCT00698646|E1|Reported Event|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
483015|NCT00698685|B1|Baseline|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
483077|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
483016|NCT00698685|P1|Participant Flow|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
483017|NCT00698685|O1|Outcome|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
483018|NCT00698685|O1|Outcome|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
483019|NCT00698685|E1|Reported Event|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
483020|NCT00698815|B4|Baseline|Total|Total of all reporting groups
483021|NCT00698815|B3|Baseline|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
483022|NCT00698815|B2|Baseline|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
483023|NCT00698815|B1|Baseline|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
483046|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
483024|NCT00698815|P3|Participant Flow|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
483025|NCT00698815|P2|Participant Flow|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
483026|NCT00698815|P1|Participant Flow|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
483027|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
483028|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
483029|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
483030|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
483031|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
483032|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
483033|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
483034|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
483078|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
483035|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
483036|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
483037|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
483038|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
483039|NCT00698815|E3|Reported Event|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
483040|NCT00698815|E2|Reported Event|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
483041|NCT00698815|E1|Reported Event|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
483042|NCT00698841|B1|Baseline|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
483043|NCT00698841|P1|Participant Flow|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
483044|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
483045|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
483047|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
483048|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
483049|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
483050|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
483051|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
483052|NCT00698841|E1|Reported Event|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
483053|NCT00698867|B1|Baseline|Discovery™ Elbow|Discovery™ Elbow minimally constrained
483054|NCT00698867|P1|Participant Flow|Discovery™ Elbow|Discovery™ Elbow minimally constrained
483055|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
483056|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
483057|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
483058|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
483059|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
483060|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
483061|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
483062|NCT00698867|E1|Reported Event|Discovery™ Elbow|Discovery™ Elbow minimally constrained
483063|NCT00698932|B3|Baseline|Total|Total of all reporting groups
483064|NCT00698932|B2|Baseline|Placebo|Placebo tablet, once daily( OD) for 24 weeks
483065|NCT00698932|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
483066|NCT00698932|P2|Participant Flow|Placebo|Placebo tablet, once daily( OD) for 24 weeks
483067|NCT00698932|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
483068|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
483069|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
483070|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
483071|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
483072|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
483073|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
483074|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
483079|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
483080|NCT00698932|E2|Reported Event|Placebo|Placebo tablet, once daily( OD) for 24 weeks
483081|NCT00698932|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
483082|NCT00688844|B1|Baseline|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
483083|NCT00688844|P1|Participant Flow|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
483084|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
483085|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
483086|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
483087|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
483088|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
483089|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
483090|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
483091|NCT00688844|E1|Reported Event|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
483092|NCT00688870|B3|Baseline|Total|Total of all reporting groups
483093|NCT00688870|B2|Baseline|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483154|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
483155|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
483156|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
483157|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
483094|NCT00688870|B1|Baseline|13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483095|NCT00688870|P2|Participant Flow|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483096|NCT00688870|P1|Participant Flow|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483097|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483098|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483099|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483100|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483128|NCT00689026|B2|Baseline|Control|PEG colon cleansing
483129|NCT00689026|B1|Baseline|Experimental|PEG plus lubiprostone colon cleansing
483101|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483102|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483103|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483104|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483105|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483158|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
483159|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
483629|NCT00699400|O2|Outcome|Vitrification|
483106|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483107|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483108|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483109|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483110|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483111|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483112|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483130|NCT00689026|P2|Participant Flow|Control|Control group received the standard treatment of polyethylene glycol electrolytes the evening prior to the colonoscopy.
483131|NCT00689026|P1|Participant Flow|Experimental|Experimental group received one dose of polyethylene glycol electrolyte (PEG) and one does of lubiprostone two hours prior to and two hours after PED completion on the evening prior to the colonoscopy.
483113|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483114|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483115|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483116|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483117|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483118|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483119|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483120|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483121|NCT00688870|E6|Reported Event|Toddler Dose 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 15 months of age (toddler dose).
483122|NCT00688870|E5|Reported Event|Toddler Dose 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 15 months of age (toddler dose).
483123|NCT00688870|E4|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483124|NCT00688870|E3|Reported Event|After the Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483125|NCT00688870|E2|Reported Event|Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483126|NCT00688870|E1|Reported Event|Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
483127|NCT00689026|B3|Baseline|Total|Total of all reporting groups
483132|NCT00689026|O2|Outcome|Control|All patients in the control will receive a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy.
483133|NCT00689026|O1|Outcome|Experimental|Lubiprostone: Two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4 Liters PEG prep (before and after the 4 Liters PEG prep).
483134|NCT00689026|E2|Reported Event|Control|Patients received a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy
483135|NCT00689026|E1|Reported Event|Treatment|Patients who were given a two doses of lubiprostone with the PEG colon cleansing solution on the day prior the recorded colonoscopy for cleansing grading
483136|NCT00689052|B3|Baseline|Total|Total of all reporting groups
483137|NCT00689052|B2|Baseline|Pramipexole|Patients receiving pramipexole
483138|NCT00689052|B1|Baseline|Placebo|Patients receiving matching placebo
483139|NCT00689052|P2|Participant Flow|Pramipexole|Patients receive pramipexole in dose up-titration steps
483140|NCT00689052|P1|Participant Flow|Placebo|Patients receive placebo in dose up-titration steps
483141|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
483142|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
483143|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
483144|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
483145|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
483146|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
483147|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
483148|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
483149|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
483150|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
483151|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
483152|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
483153|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
483630|NCT00699400|O1|Outcome|Slow Freezing|
483170|NCT00689091|B2|Baseline|Minimum Anesthesia Concentration Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.
Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
483171|NCT00689091|B1|Baseline|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.
Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
483172|NCT00689091|P2|Participant Flow|Minimum Anesthesia Contration Alert|"This group will receive an alert if total MAC (Minimum Anesthesia Concenration) (including intravenous infusions) is <0.5 age-adjusted.
Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
483173|NCT00689091|P1|Participant Flow|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.
Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
483174|NCT00689091|O2|Outcome|MAC Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.
Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
483175|NCT00689091|O1|Outcome|BIS Group|"This group will have BIS values visible and will receive alerts when the value is >60.
Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
483176|NCT00689091|E2|Reported Event|Miniumum Anesthesia Concentration Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.
Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
483177|NCT00689091|E1|Reported Event|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.
Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
483178|NCT00689104|B5|Baseline|Total|Total of all reporting groups
483179|NCT00689104|B4|Baseline|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483180|NCT00689104|B3|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483181|NCT00689104|B2|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483182|NCT00689104|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483183|NCT00689104|P4|Participant Flow|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483184|NCT00689104|P3|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483185|NCT00689104|P2|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483186|NCT00689104|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483187|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483188|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483189|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483190|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483191|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483192|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483193|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483194|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483195|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483196|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483197|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483198|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483199|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483200|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483201|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483202|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483203|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483631|NCT00699400|O3|Outcome|All Participants|
483204|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483205|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483206|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483207|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483208|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483209|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483210|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483211|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483212|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483213|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483214|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483215|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483216|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483217|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483218|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483219|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483220|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483221|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483222|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483223|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483224|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483225|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483226|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483227|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483228|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483229|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483230|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483231|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483232|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483233|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483234|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483235|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483236|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483237|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483238|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483239|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483240|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483241|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483242|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483505|NCT00699153|B1|Baseline|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
483243|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483244|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483245|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483246|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483247|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483248|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483249|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483250|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483251|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483252|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483253|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483254|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483255|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483256|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483257|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483392|NCT00689260|O1|Outcome|Log Aware|Dose Log Aware and Daily Diary Enabled
483258|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483259|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483260|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483261|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483262|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483263|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483264|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483265|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483266|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483267|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483268|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483269|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483270|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483271|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483272|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483273|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483274|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483275|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483276|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483277|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483278|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483279|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483280|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483281|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483282|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483283|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483284|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483285|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483286|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483287|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483288|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483289|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483290|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483291|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483292|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483293|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483294|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483295|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483296|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
496038|NCT00724984|B3|Baseline|Cohort 3(45 mg/m2, 7days/wk)/Phase 1|
483297|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483298|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483299|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483300|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483301|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483302|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483303|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483304|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483305|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483306|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483307|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483308|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483309|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483310|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483311|NCT00689104|E4|Reported Event|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
483312|NCT00689104|E3|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483313|NCT00689104|E2|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
483314|NCT00689104|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
483315|NCT00689117|B5|Baseline|Total|Total of all reporting groups
483316|NCT00689117|B4|Baseline|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483317|NCT00689117|B3|Baseline|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483318|NCT00689117|B2|Baseline|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483319|NCT00689117|B1|Baseline|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483320|NCT00689117|P4|Participant Flow|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483321|NCT00689117|P3|Participant Flow|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483322|NCT00689117|P2|Participant Flow|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483323|NCT00689117|P1|Participant Flow|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483324|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483325|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483326|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483327|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483328|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483329|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483330|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483331|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483332|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483333|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483334|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483393|NCT00689260|E2|Reported Event|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
483335|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483336|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483337|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483338|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483339|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483340|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483341|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483342|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483343|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483344|NCT00689117|E4|Reported Event|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483345|NCT00689117|E3|Reported Event|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483346|NCT00689117|E2|Reported Event|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483347|NCT00689117|E1|Reported Event|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
483348|NCT00689221|B3|Baseline|Total|Total of all reporting groups
483349|NCT00689221|B2|Baseline|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483350|NCT00689221|B1|Baseline|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483351|NCT00689221|P2|Participant Flow|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483506|NCT00699153|P2|Participant Flow|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
483352|NCT00689221|P1|Participant Flow|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483353|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483354|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483355|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483394|NCT00689260|E1|Reported Event|Log Aware|Dose Log Aware and Daily Diary Enabled
483395|NCT00689299|B4|Baseline|Total|Total of all reporting groups
483396|NCT00689299|B3|Baseline|2.1 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (F|Active Dose Group B
483397|NCT00689299|B2|Baseline|0.21 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (|Active Dose Group A
483398|NCT00689299|B1|Baseline|Placebo|Placebo - Dose Group C
483726|NCT00699699|P1|Participant Flow|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
483356|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483357|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483358|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483359|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483360|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483361|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483362|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483363|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483364|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483365|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483366|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483399|NCT00689299|P3|Participant Flow|0.21 Units Fel d 1|"Active Dose Group A
From a concentration of 14.0 Units/mL of Fel d 1 diluted 1:10 v/v, a maintenance dose of 0.15 mL (0.21 Units Fel d 1) was administered as a daily oral liquid via sublingual route."
483400|NCT00689299|P2|Participant Flow|2.1 Units Fel d 1|"Active Dose Group B
From a concentration of 14.0 Units/mL of Fel d 1, a maintenance dose of 0.15 mL (2.1 Units Fel d 1) was administered as a daily oral liquid via sublingual route."
483530|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
483367|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483368|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483369|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483370|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483371|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483372|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483417|NCT00689338|E1|Reported Event|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
483418|NCT00689351|B3|Baseline|Total|Total of all reporting groups
483373|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
483374|NCT00689221|E2|Reported Event|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
483375|NCT00689221|E1|Reported Event|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 will be optional in participants without disease progression, If cilengitide treatment considered beneficial in the opinion of the Investigator,
483376|NCT00689260|B3|Baseline|Total|Total of all reporting groups
483377|NCT00689260|B2|Baseline|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
483378|NCT00689260|B1|Baseline|Log Aware|Dose Log Aware and Daily Diary Enabled
483379|NCT00689260|P2|Participant Flow|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
483380|NCT00689260|P1|Participant Flow|Log Aware|Dose Log Aware and Daily Diary Enabled
483381|NCT00689260|O3|Outcome|Total|
483382|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
483383|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
483384|NCT00689260|O3|Outcome|Total|
483385|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
483386|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
483387|NCT00689260|O3|Outcome|Total|
483388|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
483389|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
483390|NCT00689260|O3|Outcome|Total|
483391|NCT00689260|O2|Outcome|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
483401|NCT00689299|P1|Participant Flow|Placebo|Maintenance dose of 0.15 mL of liquid placebo administered as a daily oral liquid via sublingual route.
483402|NCT00689299|O3|Outcome|2.1 Units Standardized Allergenic Extract, Cat Hair|Dose Group B
483403|NCT00689299|O2|Outcome|0.21 Units Standardized Allergenic Extract, Cat Hair|Dose Group A
483404|NCT00689299|O1|Outcome|Placebo|Dose Group C: placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)
483405|NCT00689299|E3|Reported Event|Dose Group B|2.1 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
483406|NCT00689299|E2|Reported Event|Dose Group A|0.21 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
483407|NCT00689299|E1|Reported Event|Dose Group C|placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)
483408|NCT00689338|B1|Baseline|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
483409|NCT00689338|P1|Participant Flow|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
483410|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
483411|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
483412|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
483413|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
483414|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
483415|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
483416|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
483419|NCT00689351|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483420|NCT00689351|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483421|NCT00689351|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483422|NCT00689351|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483423|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483424|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483425|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483426|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483427|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483428|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483429|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483430|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483431|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483488|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483432|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483433|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483434|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483435|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483436|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483437|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483438|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483439|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483440|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483441|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483442|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483443|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483444|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483445|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483446|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
483447|NCT00689351|E6|Reported Event|Toddler Dose 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC ) 0.5mL dose administered IM at 12 months of age (toddler dose).
483448|NCT00689351|E5|Reported Event|Toddler Dose 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered IM at 12 months of age (toddler dose).
483449|NCT00689351|E4|Reported Event|After the Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
483450|NCT00689351|E3|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
483627|NCT00699400|O1|Outcome|Slow Freezing|
483451|NCT00689351|E2|Reported Event|Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).
483452|NCT00689351|E1|Reported Event|Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
483453|NCT00689390|B3|Baseline|Total|Total of all reporting groups
483454|NCT00689390|B2|Baseline|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
483455|NCT00689390|B1|Baseline|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
483456|NCT00689390|P2|Participant Flow|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
483457|NCT00689390|P1|Participant Flow|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
483458|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
483459|NCT00689390|O1|Outcome|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
483529|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
483460|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
483461|NCT00689390|O1|Outcome|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
483462|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies With TE-RAVs|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
483463|NCT00689390|O1|Outcome|Participants From Boceprevir Studies With TE-RAVs|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
483464|NCT00689390|O3|Outcome|Previous SVR on PR Only|Participants who previously received PR only in boceprevir or narlaprevir treatment studies and achieved SVR. No treatment was administered in the current follow-up study
483465|NCT00689390|O2|Outcome|Previous SVR on Narlaprevir + PR|Participants who previously received narlaprevir plus PR in treatment studies and achieved SVR. No treatment was administered in the current follow-up study.
483466|NCT00689390|O1|Outcome|Previous SVR on Boceprevir + PR|Participants who previously received boceprevir plus PR in treatment studies and achieved sustained virologic response (SVR). No treatment was administered in the current follow-up study.
483467|NCT00689390|O3|Outcome|Previous SVR on PR Only|Participants who previously received PR only in boceprevir or narlaprevir treatment studies and achieved SVR. No treatment was administered in the current follow-up study
483468|NCT00689390|O2|Outcome|Previous SVR on Narlaprevir + PR|Participants who previously received narlaprevir plus PR in treatment studies and achieved SVR. No treatment was administered in the current follow-up study.
483469|NCT00689390|O1|Outcome|Previous SVR on Boceprevir + PR|Participants who previously received boceprevir plus PR in treatment studies and achieved sustained virologic response (SVR). No treatment was administered in the current follow-up study.
483470|NCT00689390|E2|Reported Event|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
483471|NCT00689390|E1|Reported Event|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
483472|NCT00689481|B3|Baseline|Total|Total of all reporting groups
483502|NCT00699140|E1|Reported Event|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols
IGIV3I Grifols: Immune Globulin Intravenous (Human)"
483473|NCT00689481|B2|Baseline|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483474|NCT00689481|B1|Baseline|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483475|NCT00689481|P2|Participant Flow|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483476|NCT00689481|P1|Participant Flow|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483477|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483478|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483479|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483480|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483481|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483482|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483483|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483484|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483485|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483486|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483487|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
496039|NCT00724984|B2|Baseline|Cohort 2(45 mg/m2, 5days/wk)/Phase 1|
483489|NCT00689481|E2|Reported Event|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483490|NCT00689481|E1|Reported Event|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
483491|NCT00699140|B1|Baseline|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols
IGIV3I Grifols: Immune Globulin Intravenous (Human)
Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
483492|NCT00699140|P1|Participant Flow|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols
IGIV3I Grifols: Immune Globulin Intravenous (Human)
Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses"
483493|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols
IGIV3I Grifols: Immune Globulin Intravenous (Human)
Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses"
483494|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols
Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.
IGIV3I Grifols: Immune Globulin Intravenous (Human)"
483495|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols
IGIV3I Grifols: Immune Globulin Intravenous (Human)
Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
483496|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols. IGIV3I Grifols: Immune Globulin Intravenous (Human). All adverse events (AEs) are tabulated and summarized. Incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of MedDRA.
The frequency of patients and infusions associated with at least one AE are estimated as the primary safety endpoint."
483497|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols
IGIV3I Grifols: Immune Globulin Intravenous (Human)
Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
483498|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols
IGIV3I Grifols: Immune Globulin Intravenous (Human)
Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
483499|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols
IGIV3I Grifols: Immune Globulin Intravenous (Human)
Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
483500|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols
IGIV3I Grifols: Immune Globulin Intravenous (Human)
Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
483501|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols
IGIV3I Grifols: Immune Globulin Intravenous (Human)
Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
483507|NCT00699153|P1|Participant Flow|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
483508|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
483509|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
483510|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
483511|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
483512|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
483513|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
483514|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
483515|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
483516|NCT00699153|E2|Reported Event|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
483517|NCT00699153|E1|Reported Event|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
483518|NCT00699192|B4|Baseline|Total|Total of all reporting groups
483519|NCT00699192|B3|Baseline|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
483520|NCT00699192|B2|Baseline|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
483521|NCT00699192|B1|Baseline|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
483522|NCT00699192|P3|Participant Flow|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
483523|NCT00699192|P2|Participant Flow|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
483524|NCT00699192|P1|Participant Flow|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
483525|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
483526|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
483527|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
483528|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
483531|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
483532|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
483533|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
483534|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
483535|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
483536|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
483537|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
483538|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
483539|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
483540|NCT00699192|E3|Reported Event|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
483541|NCT00699192|E2|Reported Event|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
483542|NCT00699192|E1|Reported Event|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
483543|NCT00699283|B3|Baseline|Total Title|
483544|NCT00699283|B2|Baseline|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
483545|NCT00699283|B1|Baseline|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
483546|NCT00699283|P2|Participant Flow|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
483547|NCT00699283|P1|Participant Flow|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
483548|NCT00699283|O1|Outcome|Efficacy Set (Brivaracetam 50 mg Treated Subjects)|"50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
The Efficacy Analysis Set (EFF) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs."
483549|NCT00699283|E2|Reported Event|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
483550|NCT00699283|E1|Reported Event|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
483551|NCT00699335|B1|Baseline|Matrifen®|All patients enrolled
483552|NCT00699335|P1|Participant Flow|Matrifen®|All patients enrolled
483553|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
483554|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
483555|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
483556|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
483557|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
483558|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
483559|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
483560|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
483561|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
483562|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
483563|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
483564|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
483565|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
483566|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
483567|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
483568|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
483569|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
483570|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
483571|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
483572|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
483573|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
483574|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
483575|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
483576|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
483577|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
483578|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
483579|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
483580|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
483581|NCT00699335|E1|Reported Event|Matrifen®|Patients included and treated with at least one application of Matrifen®
483724|NCT00699660|E1|Reported Event|Arm 1|"PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
483725|NCT00699699|B1|Baseline|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
483582|NCT00699348|B1|Baseline|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
483583|NCT00699348|P1|Participant Flow|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period [Week -4 to Week 0]) intravenous methoxy polyethylene glycolepoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
483584|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
483585|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
483586|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
483587|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
483588|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
483589|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
483590|NCT00699348|E1|Reported Event|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
483591|NCT00699374|B3|Baseline|Total|Total of all reporting groups
483592|NCT00699374|B2|Baseline|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483593|NCT00699374|B1|Baseline|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483594|NCT00699374|P2|Participant Flow|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483595|NCT00699374|P1|Participant Flow|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483596|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483597|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483598|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483599|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483600|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483656|NCT00699608|P6|Participant Flow|Placebo First, Zopiclone Second, Eszopiclone Third|Placebo during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
483601|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483602|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483603|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483604|NCT00699374|E2|Reported Event|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483605|NCT00699374|E1|Reported Event|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
483606|NCT00699400|B4|Baseline|Total|Total of all reporting groups
483607|NCT00699400|B3|Baseline|Pre-Freeze Discontinuations|Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
483608|NCT00699400|B2|Baseline|Vitrification|Subjects that participated in one or more vitrification cycles
483609|NCT00699400|B1|Baseline|Slow Freeze|Subjects that participated in one or more slow-freeze cycles
483610|NCT00699400|P6|Participant Flow|Pre-freeze Discontinuations|Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
483611|NCT00699400|P5|Participant Flow|Both (Slow Freeze and Vitrification)|Participants who underwent both slow freezing and vitrification cycles (one cycle of each freezing technique).
483612|NCT00699400|P4|Participant Flow|Vitrification (Two Cycles)|Subjects who participated in two freezing cycles of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
483613|NCT00699400|P3|Participant Flow|Vitrification (One Cycle)|Subjects who participated in one freezing cycle of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
483614|NCT00699400|P2|Participant Flow|Slow Freeze (Two Cycles)|Subjects who participated in two freezing cycles of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
483615|NCT00699400|P1|Participant Flow|Slow Freeze (One Cycle)|Subjects who participated in one freezing cycle of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
483616|NCT00699400|O3|Outcome|All Participants|
483617|NCT00699400|O2|Outcome|Vitrification|
483618|NCT00699400|O1|Outcome|Slow Freezing|
483619|NCT00699400|O3|Outcome|All Participants|
483620|NCT00699400|O2|Outcome|Vitrification|
483621|NCT00699400|O1|Outcome|Slow Freezing|
483622|NCT00699400|O3|Outcome|All Participants|
483623|NCT00699400|O2|Outcome|Vitrification|
483624|NCT00699400|O1|Outcome|Slow Freezing|
483625|NCT00699400|O3|Outcome|All Participants|
483626|NCT00699400|O2|Outcome|Vitrification|
483632|NCT00699400|O2|Outcome|Vitrification|
483633|NCT00699400|O1|Outcome|Slow Freezing|
483634|NCT00699400|O3|Outcome|All Participants|
483635|NCT00699400|O2|Outcome|Vitrification|
483636|NCT00699400|O1|Outcome|Slow Freezing|
483637|NCT00699400|O3|Outcome|All Participants|
483638|NCT00699400|O2|Outcome|Vitrification|
483639|NCT00699400|O1|Outcome|Slow Freezing|
483640|NCT00699400|O3|Outcome|All Participants|
483641|NCT00699400|O2|Outcome|Vitrification|
483642|NCT00699400|O1|Outcome|Slow Freezing|
483643|NCT00699400|E3|Reported Event|All Participants|
483644|NCT00699400|E2|Reported Event|Vitrification|
483645|NCT00699400|E1|Reported Event|Slow Freezing|
483646|NCT00699413|B3|Baseline|Total|Total of all reporting groups
483647|NCT00699413|B2|Baseline|Control Arm|nutrition education plus inactive supplement
483648|NCT00699413|B1|Baseline|Intervention Arm|nutrition education plus active supplement
483649|NCT00699413|P2|Participant Flow|Control Arm|nutrition education plus inactive supplement
483650|NCT00699413|P1|Participant Flow|Intervention Arm|nutrition education plus active supplement
483651|NCT00699413|O2|Outcome|Control Arm|nutrition education plus inactive supplement
483652|NCT00699413|O1|Outcome|Intervention Arm|nutrition education plus active supplement
483653|NCT00699413|E2|Reported Event|Control Arm|nutrition education plus inactive supplement
483654|NCT00699413|E1|Reported Event|Intervention Arm|nutrition education plus active supplement
483655|NCT00699608|B1|Baseline|Entire Study Population|
483723|NCT00699660|E2|Reported Event|Arm 2|"Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
496040|NCT00724984|B1|Baseline|Cohort 1(30 mg/m2, 5days/wk)/Phase 1|
483657|NCT00699608|P5|Participant Flow|Placebo First, Eszopiclone Second, Zopiclone Third|Placebo during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
483658|NCT00699608|P4|Participant Flow|Zopiclone First, Placebo Second, Eszopiclone Third|7.5 mg zopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
483659|NCT00699608|P3|Participant Flow|Zopiclone First, Eszopiclone Second, Placebo Third|7.5 mg zopiclone during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
483660|NCT00699608|P2|Participant Flow|Eszopiclone First, Placebo Second, Zopiclone Third|3 mg eszopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
483661|NCT00699608|P1|Participant Flow|Eszopiclone First, Zopiclone Second, Placebo Third|3 mg eszopiclone during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
483662|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483663|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483664|NCT00699608|O1|Outcome|Placebo|Placebo
483665|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483666|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483667|NCT00699608|O1|Outcome|Placebo|Placebo
483668|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483669|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483670|NCT00699608|O1|Outcome|Placebo|Placebo
483671|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483672|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483673|NCT00699608|O1|Outcome|Placebo|Placebo
483674|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483675|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483676|NCT00699608|O1|Outcome|Placebo|Placebo
483677|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483678|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483679|NCT00699608|O1|Outcome|Placebo|Placebo
483680|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483681|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483682|NCT00699608|O1|Outcome|Placebo|Placebo
483683|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483684|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483685|NCT00699608|O1|Outcome|Placebo|Placebo
483686|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483687|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483688|NCT00699608|O1|Outcome|Placebo|Placebo
483689|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483690|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483691|NCT00699608|O1|Outcome|Placebo|Placebo
483692|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483693|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483694|NCT00699608|O1|Outcome|Placebo|Placebo
483695|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483696|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483697|NCT00699608|O1|Outcome|Placebo|Placebo
483698|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483699|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483700|NCT00699608|O1|Outcome|Placebo|Placebo
483701|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483702|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483703|NCT00699608|O1|Outcome|Placebo|Placebo
483704|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
483705|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
483706|NCT00699608|O1|Outcome|Placebo|Placebo
483707|NCT00699608|E3|Reported Event|Zopiclone|7.5 mg Zopiclone
483708|NCT00699608|E2|Reported Event|Eszopiclone|3 mg Eszopiclone
483709|NCT00699608|E1|Reported Event|Placebo|Placebo
483710|NCT00699660|B3|Baseline|Total|Total of all reporting groups
483711|NCT00699660|B2|Baseline|Arm 2|"Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
483712|NCT00699660|B1|Baseline|Arm 1|"PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
483713|NCT00699660|P2|Participant Flow|Arm 2|"Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
483714|NCT00699660|P1|Participant Flow|Arm 1|"PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
483715|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
483716|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
483717|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
483718|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
483719|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
483720|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
483721|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
483722|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
496041|NCT00724984|P6|Participant Flow|Mantle Cell Lymphoma/Phase II|
483727|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
483728|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
483729|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
483730|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
483731|NCT00699699|E1|Reported Event|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
483732|NCT00699751|B3|Baseline|Total|Total of all reporting groups
483733|NCT00699751|B2|Baseline|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483734|NCT00699751|B1|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483735|NCT00699751|P2|Participant Flow|Placebo|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.
483736|NCT00699751|P1|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received BSoC plus radium223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.
483737|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483738|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483739|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483740|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483741|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483742|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483743|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483744|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483745|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483746|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483747|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483748|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483749|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483750|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483751|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483752|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483753|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483754|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483755|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483756|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483757|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483758|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483759|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483760|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483761|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483762|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483763|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483764|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483765|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483766|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483767|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483768|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483769|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483770|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483771|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483772|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483773|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483774|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483775|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483776|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483777|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483778|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483779|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483780|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483781|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483782|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483783|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483784|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483785|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483786|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483787|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483788|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483789|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483790|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483791|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483792|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483793|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483794|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483795|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483796|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483797|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483969|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
483798|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483799|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483800|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483801|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483802|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483803|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483804|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483805|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483806|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483807|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483808|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483809|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483810|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483811|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483812|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483813|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483814|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483815|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
483816|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
483817|NCT00699751|E3|Reported Event|Placebo Randomized, Then Switched to Radium-223 Dichloride|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.
483818|NCT00699751|E2|Reported Event|Placebo|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase.
483819|NCT00699751|E1|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Subjects received BSoC plus radium-223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.
483820|NCT00699816|B3|Baseline|Total|Total of all reporting groups
483821|NCT00699816|B2|Baseline|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
483822|NCT00699816|B1|Baseline|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
483823|NCT00699816|P2|Participant Flow|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
483824|NCT00699816|P1|Participant Flow|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
483825|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
483826|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
483827|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
483970|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
483971|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
483828|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
483829|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
483830|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
483831|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
483832|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
483833|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
484001|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
483834|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
483835|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
483836|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
483837|NCT00699816|E2|Reported Event|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
483838|NCT00699816|E1|Reported Event|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
483839|NCT00699842|B4|Baseline|Total|Total of all reporting groups
483840|NCT00699842|B3|Baseline|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483841|NCT00699842|B2|Baseline|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483842|NCT00699842|B1|Baseline|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483843|NCT00699842|P3|Participant Flow|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483844|NCT00699842|P2|Participant Flow|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483845|NCT00699842|P1|Participant Flow|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483846|NCT00699842|O3|Outcome|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483847|NCT00699842|O2|Outcome|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483848|NCT00699842|O1|Outcome|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483849|NCT00699842|O3|Outcome|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483850|NCT00699842|O2|Outcome|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483851|NCT00699842|O1|Outcome|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483852|NCT00699842|E3|Reported Event|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483853|NCT00699842|E2|Reported Event|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483854|NCT00699842|E1|Reported Event|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
15mg/day for d1-21 out of 28 days
20mg/day for d1-21 out of 28 days
25mg/day for d1-21 out of 28 days"
483855|NCT00699972|B4|Baseline|Total|Total of all reporting groups
483856|NCT00699972|B3|Baseline|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
496042|NCT00724984|P5|Participant Flow|Follicular/Phase II|
483857|NCT00699972|B2|Baseline|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
483858|NCT00699972|B1|Baseline|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
483859|NCT00699972|P3|Participant Flow|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
483860|NCT00699972|P2|Participant Flow|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
483861|NCT00699972|P1|Participant Flow|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
483862|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
483863|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
483864|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
483865|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
483866|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
483867|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
483868|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
483869|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
483870|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
483871|NCT00699972|E3|Reported Event|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
483872|NCT00699972|E2|Reported Event|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
483873|NCT00699972|E1|Reported Event|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
483874|NCT00699998|B5|Baseline|Total|Total of all reporting groups
483875|NCT00699998|B4|Baseline|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483876|NCT00699998|B3|Baseline|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483877|NCT00699998|B2|Baseline|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
483878|NCT00699998|B1|Baseline|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel : 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
483879|NCT00699998|P4|Participant Flow|Clopidogrel: 75 Years of Age or Older|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.
Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.
Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study."
483880|NCT00699998|P3|Participant Flow|Clopidogrel: <75 Years of Age|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.
Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study
Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study"
483881|NCT00699998|P2|Participant Flow|Prasugrel: 75 Years of Age or Older|"Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.
Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.
Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study."
483882|NCT00699998|P1|Participant Flow|Prasugrel: <75 Years of Age|"Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.
Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.
Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study."
483883|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.
Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.
Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study."
483934|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483884|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.
Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study
Clopidogrel : 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study"
483885|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|"Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.
Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.
Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg orally, once daily as maintenance dose through end of study."
483886|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|"Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.
Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.
Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study."
483887|NCT00699998|O2|Outcome|Clopidogrel|Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483888|NCT00699998|O1|Outcome|Prasugrel|Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study.
483889|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483890|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483891|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
483892|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
483893|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483972|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
485510|NCT00695435|B1|Baseline|Overall Study|Overall Study
483894|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483895|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
483896|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
483897|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483898|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483899|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
483997|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
483900|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
483901|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483902|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483903|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
483904|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
483905|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483906|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483907|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
483908|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
483926|NCT00700011|P2|Participant Flow|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483909|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483910|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483911|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
483912|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
483913|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483914|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483915|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
496043|NCT00724984|P4|Participant Flow|Cohort 4(60mg/m2,7days/wk)/Phase 1|
483916|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
483917|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483918|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483919|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
483920|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
483921|NCT00699998|E2|Reported Event|Clopidogrel|Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
483922|NCT00699998|E1|Reported Event|Prasugrel|Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study.
483923|NCT00700011|B3|Baseline|Total|Total of all reporting groups
483924|NCT00700011|B2|Baseline|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483925|NCT00700011|B1|Baseline|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483968|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
483927|NCT00700011|P1|Participant Flow|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483928|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483929|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483930|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483931|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483932|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483933|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483998|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
483999|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
484000|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
483935|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483936|NCT00700011|E2|Reported Event|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483937|NCT00700011|E1|Reported Event|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
483938|NCT00700063|B9|Baseline|Total|Total of all reporting groups
483939|NCT00700063|B8|Baseline|8. Vehicle Gel|Three days treatment, day 1, 2, 3
483940|NCT00700063|B7|Baseline|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
483941|NCT00700063|B6|Baseline|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
483942|NCT00700063|B5|Baseline|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
483943|NCT00700063|B4|Baseline|4. Vehicle Gel|Two days treatment, day 1, 2
483944|NCT00700063|B3|Baseline|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
483945|NCT00700063|B2|Baseline|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
483946|NCT00700063|B1|Baseline|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
483947|NCT00700063|P8|Participant Flow|8. Vehicle Gel|Three days treatment, day 1, 2, 3
483948|NCT00700063|P7|Participant Flow|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
483949|NCT00700063|P6|Participant Flow|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
483950|NCT00700063|P5|Participant Flow|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
483951|NCT00700063|P4|Participant Flow|4. Vehicle Gel|Two days treatment, day 1, 2
483952|NCT00700063|P3|Participant Flow|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
483953|NCT00700063|P2|Participant Flow|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
483954|NCT00700063|P1|Participant Flow|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
483955|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
483956|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
483957|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
483958|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
483959|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
483960|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
483961|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
483962|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
483963|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
483964|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
483965|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
483966|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
483967|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
483973|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
483974|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
483975|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
483976|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
483977|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
483978|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
483979|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
483980|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
483981|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
483982|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
483983|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
483984|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
483985|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
483986|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
483987|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
483988|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
483989|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
483990|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
483991|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
483992|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
483993|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
483994|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
483995|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
483996|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
484002|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
484003|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
484004|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
484005|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
484006|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
484007|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
484008|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
484009|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
484010|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
484011|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
484012|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
484013|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
484014|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
484015|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
484016|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
484017|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
484018|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
484019|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
484020|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
484021|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
484022|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
484023|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
484024|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
484025|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
484026|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
484027|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
484028|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
484029|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
484030|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
484031|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
484032|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
484033|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
484034|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
484035|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
484036|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
484037|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
484038|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
484039|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
484040|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
484041|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
484042|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
484043|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
484044|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
484045|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
484046|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
484047|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
484048|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
484049|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
484050|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
484051|NCT00700063|E8|Reported Event|8. Vehicle Gel|Three days treatment, day 1, 2, 3
484052|NCT00700063|E7|Reported Event|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
484053|NCT00700063|E6|Reported Event|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
484054|NCT00700063|E5|Reported Event|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
484055|NCT00700063|E4|Reported Event|4. Vehicle Gel|Two days treatment, day 1, 2
484056|NCT00700063|E3|Reported Event|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
484057|NCT00700063|E2|Reported Event|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
484058|NCT00700063|E1|Reported Event|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
484059|NCT00700102|B3|Baseline|Total|Total of all reporting groups
484060|NCT00700102|B2|Baseline|Chemotherapy + Bevacizumab|"Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
Chemotherapy: As prescribed
Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle."
484061|NCT00700102|B1|Baseline|Chemotherapy|"Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
Chemotherapy: As prescribed"
484062|NCT00700102|P2|Participant Flow|Chemotherapy + Bevacizumab|"Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
Chemotherapy: As prescribed
Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle."
484063|NCT00700102|P1|Participant Flow|Chemotherapy|"Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
Chemotherapy: As prescribed"
484064|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
496044|NCT00724984|P3|Participant Flow|Cohort 3(45mg/m2,7days/wk)/Phase 1|
484065|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
484066|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
484067|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
484068|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
484069|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
484070|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
484071|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
484072|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
484073|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
484074|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
484075|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
484076|NCT00700102|E2|Reported Event|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
484077|NCT00700102|E1|Reported Event|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
484078|NCT00700115|B3|Baseline|Total|Total of all reporting groups
484079|NCT00700115|B2|Baseline|Standard HAART|Pre-study standard HAART regimen
484080|NCT00700115|B1|Baseline|Kaletra + Isentress|switched to Kaletra + Isentress
484081|NCT00700115|P2|Participant Flow|Standard HAART|Pre-study standard HAART regimen
484082|NCT00700115|P1|Participant Flow|Kaletra + Isentress|Switched to Kaletra + Isentress
484083|NCT00700115|O2|Outcome|Standard HAART|Pre-study standard HAART regimen
484084|NCT00700115|O1|Outcome|Kaletra + Isentress|switched to Kaletra + Isentress
484085|NCT00700115|O2|Outcome|Standard HAART|Pre-study standard HAART regimen
484086|NCT00700115|O1|Outcome|Kaletra + Isentress|switched to Kaletra + Isentress
484087|NCT00700115|E2|Reported Event|Standard HAART|Pre-study standard HAART regimen
484088|NCT00700115|E1|Reported Event|Kaletra + Isentress|switched to Kaletra + Isentress
484089|NCT00700141|B1|Baseline|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
484090|NCT00700141|P1|Participant Flow|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
484091|NCT00700141|O1|Outcome|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
484092|NCT00700141|O1|Outcome|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
484093|NCT00700141|E1|Reported Event|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
484094|NCT00700180|B3|Baseline|Total|Total of all reporting groups
484095|NCT00700180|B2|Baseline|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484248|NCT00700635|B3|Baseline|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
484096|NCT00700180|B1|Baseline|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484097|NCT00700180|P2|Participant Flow|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484098|NCT00700180|P1|Participant Flow|Bevacizumab 7.5 Milligrams (mg) Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg per kilogram (mg/kg) intravenously (IV) on Day 1; either carboplatin at a dose required to achieve an area under the concentration-time curve (AUC) of 6 mg per milliliter (mg/mL) IV and paclitaxel 200 mg per square meter (mg/m^2) IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484150|NCT00700310|B3|Baseline|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
484274|NCT00700713|B2|Baseline|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26
484099|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484100|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484101|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484102|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484103|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484104|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484249|NCT00700635|B2|Baseline|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
484105|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484106|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484107|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484151|NCT00700310|B2|Baseline|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
484152|NCT00700310|B1|Baseline|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
484153|NCT00700310|P4|Participant Flow|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
485427|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
484108|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484109|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484110|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484111|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484112|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484113|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484114|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484115|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484116|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484154|NCT00700310|P3|Participant Flow|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
484155|NCT00700310|P2|Participant Flow|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
484156|NCT00700310|P1|Participant Flow|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
485536|NCT00695565|B3|Baseline|Total|Total of all reporting groups
484117|NCT00700180|E2|Reported Event|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484118|NCT00700180|E1|Reported Event|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.
Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
484119|NCT00700271|B3|Baseline|Total|Total of all reporting groups
484120|NCT00700271|B2|Baseline|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484121|NCT00700271|B1|Baseline|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484122|NCT00700271|P2|Participant Flow|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484123|NCT00700271|P1|Participant Flow|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
486650|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
484124|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484125|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484126|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484127|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
486619|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
484128|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484129|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484130|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484131|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484132|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484133|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484241|NCT00700622|P2|Participant Flow|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
484134|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484135|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484136|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484137|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484157|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
484275|NCT00700713|B1|Baseline|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
484138|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484139|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484140|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484141|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484142|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484143|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484144|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484145|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484146|NCT00700271|E2|Reported Event|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484147|NCT00700271|E1|Reported Event|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
484148|NCT00700310|B5|Baseline|Total|Total of all reporting groups
484149|NCT00700310|B4|Baseline|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
484158|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
484159|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
484160|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
484161|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
484162|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
484163|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
484164|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
484165|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
484166|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
484167|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
484168|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
484169|NCT00700310|E4|Reported Event|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
484170|NCT00700310|E3|Reported Event|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
484171|NCT00700310|E2|Reported Event|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
484172|NCT00700310|E1|Reported Event|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
484173|NCT00700375|B3|Baseline|Total|Total of all reporting groups
484174|NCT00700375|B2|Baseline|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
484175|NCT00700375|B1|Baseline|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
486651|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
484176|NCT00700375|P2|Participant Flow|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
484177|NCT00700375|P1|Participant Flow|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
484178|NCT00700375|O2|Outcome|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
484197|NCT00700427|P2|Participant Flow|Atomoxetine (Study Period 3A)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during double-blind randomized withdrawal phase (Study Period 3).
484198|NCT00700427|P1|Participant Flow|Atomoxetine (Study Period 2)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2).
484199|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
496045|NCT00724984|P2|Participant Flow|Cohort 2(45mg/m2,5days/wk)/Phase 1|
484179|NCT00700375|O1|Outcome|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
484180|NCT00700375|E2|Reported Event|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
484181|NCT00700375|E1|Reported Event|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
484182|NCT00700401|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
484183|NCT00700401|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
484184|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
484185|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
484242|NCT00700622|P1|Participant Flow|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
484243|NCT00700622|O2|Outcome|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
484186|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
484187|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
484188|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
484189|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
484190|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
484191|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
484192|NCT00700401|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
484193|NCT00700427|B1|Baseline|Atomoxetine (40-100 mg)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment period (Study Period 2).
484194|NCT00700427|P5|Participant Flow|Atomoxetine (Study Period 4)|Participants who received either atomoxetine or placebo and completed the last visit of Study Period 3 who were in countries where the adult ADHD indication for atomoxetine was not approved were allowed to participant in Study Period 4 (Open-label Extension). Participants received 40 mg/day atomoxetine orally for at least 7 days after which it was increased to 80-100 mg/day atomoxetine orally for up to 2.3 years.
484195|NCT00700427|P4|Participant Flow|Placebo (Study Period 3B)|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484196|NCT00700427|P3|Participant Flow|Atomoxetine (Study Period 3B)|80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484200|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484201|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484202|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484203|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484204|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484205|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484206|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484207|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484208|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484209|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484210|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484211|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484212|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484213|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484214|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
484215|NCT00700427|E4|Reported Event|Atomoxetine (Study Period 4; Open-Label Extension)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A) and for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B), followed by a 2 year open label extension (Study Period 4). The open-label extension was optional and only offered to participants living in countries where atomoxetine for the adult ADHD indication had not been approved who had completed the Study Period 3B and were receiving benefit from the drug.
484216|NCT00700427|E3|Reported Event|Placebo (Study Period 3B)|"40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).
Followed by Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B)."
484217|NCT00700427|E2|Reported Event|Atomoxetine (Study Period 3B)|"40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).
Followed by 80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B)."
484218|NCT00700427|E1|Reported Event|Atomoxetine (Study Periods 2 and 3A)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).
484219|NCT00700440|B1|Baseline|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
484220|NCT00700440|P1|Participant Flow|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
484221|NCT00700440|O1|Outcome|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
484222|NCT00700440|E1|Reported Event|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
484223|NCT00700570|B3|Baseline|Total|Total of all reporting groups
484224|NCT00700570|B2|Baseline|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
484234|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
486751|NCT00703391|E1|Reported Event|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
484225|NCT00700570|B1|Baseline|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
484226|NCT00700570|P2|Participant Flow|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with partial response (PR) or stable disease (SD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, repeated neoadjuvant treatment until documented resectability or progressive disease (PD). Participants could be withdrawn at any point for unacceptable toxicity.
484227|NCT00700570|P1|Participant Flow|Resected|Participants with unresectable liver metastases secondary to colorectal cancer (CRC) were assigned to receive neoadjuvant treatment of intravenous (IV) bevacizumab with oral (PO) capecitabine and IV oxaliplatin (XELOX). Bevacizumab was given as 5 milligrams per kilogram (mg/kg) on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 milligrams per meter-squared (mg/m^2) on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
484228|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
484244|NCT00700622|O1|Outcome|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
484245|NCT00700622|E2|Reported Event|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
484246|NCT00700622|E1|Reported Event|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
484247|NCT00700635|B4|Baseline|Total|Total of all reporting groups
484315|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484229|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
484230|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
484231|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
484232|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
484233|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
484271|NCT00700635|E1|Reported Event|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
484272|NCT00700713|B4|Baseline|Total|Total of all reporting groups
484273|NCT00700713|B3|Baseline|Menactra-naïve Group|Participants had never received Menactra® vaccine.
484235|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
484236|NCT00700570|O1|Outcome|All Participants|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
484237|NCT00700570|E1|Reported Event|All Participants|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
484238|NCT00700622|B3|Baseline|Total|Total of all reporting groups
484239|NCT00700622|B2|Baseline|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
484240|NCT00700622|B1|Baseline|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
486652|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
484250|NCT00700635|B1|Baseline|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
484251|NCT00700635|P3|Participant Flow|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
484252|NCT00700635|P2|Participant Flow|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
484253|NCT00700635|P1|Participant Flow|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
484254|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
484255|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
484256|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
484257|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
484258|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
484259|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
484260|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
484261|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
484262|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
484263|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
484264|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
484265|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
484266|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
484267|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
484268|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
484269|NCT00700635|E3|Reported Event|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
484270|NCT00700635|E2|Reported Event|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
484276|NCT00700713|P3|Participant Flow|Menactra-naïve Group|Participants had never received Menactra® vaccine.
484277|NCT00700713|P2|Participant Flow|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
484278|NCT00700713|P1|Participant Flow|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
484279|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
484280|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
484281|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
484282|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
484283|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
484284|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
484285|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
484286|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
484287|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
484288|NCT00700713|E3|Reported Event|Menactra-naïve Group|Participants had never received Menactra® vaccine.
484289|NCT00700713|E2|Reported Event|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
484290|NCT00700713|E1|Reported Event|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
484291|NCT00700739|B3|Baseline|Total|Total of all reporting groups
484292|NCT00700739|B2|Baseline|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484293|NCT00700739|B1|Baseline|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484294|NCT00700739|P2|Participant Flow|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484295|NCT00700739|P1|Participant Flow|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
484296|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484297|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484298|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484299|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484300|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484301|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484302|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484303|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484304|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484305|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484306|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484307|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484308|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484309|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484310|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484311|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484312|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484313|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484314|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484316|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484317|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
484318|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484319|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
484320|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484321|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
484322|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484323|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
484324|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484325|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484326|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484327|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484328|NCT00700739|E2|Reported Event|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
484329|NCT00700739|E1|Reported Event|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
484330|NCT00700752|B1|Baseline|Overall|Completed study population
484331|NCT00700752|P2|Participant Flow|Balafilcon A/Senofilcon A|balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
484332|NCT00700752|P1|Participant Flow|Senofilcon A/Balafilcon A|senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
484333|NCT00700752|O2|Outcome|Balafilcon A|silicone hydrogel contact lens worn daily with a 4-week replacement regimen
484334|NCT00700752|O1|Outcome|Senofilcon A|silicone hydrogel contact lens worn daily with a 2-week replacement regimen.
484335|NCT00700752|E2|Reported Event|Balafilcon A/Senofilcon A|balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
484336|NCT00700752|E1|Reported Event|Senofilcon A/Balafilcon A|senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
484337|NCT00700804|B3|Baseline|Total|Total of all reporting groups
484338|NCT00700804|B2|Baseline|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
484339|NCT00700804|B1|Baseline|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
484340|NCT00700804|P2|Participant Flow|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
484341|NCT00700804|P1|Participant Flow|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
484342|NCT00700804|O2|Outcome|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
484343|NCT00700804|O1|Outcome|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
484344|NCT00700804|O2|Outcome|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
484345|NCT00700804|O1|Outcome|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
484346|NCT00700804|E2|Reported Event|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
484347|NCT00700804|E1|Reported Event|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
484348|NCT00700817|B6|Baseline|Total|Total of all reporting groups
484349|NCT00700817|B5|Baseline|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484350|NCT00700817|B4|Baseline|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484351|NCT00700817|B3|Baseline|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484352|NCT00700817|B2|Baseline|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484353|NCT00700817|B1|Baseline|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484354|NCT00700817|P5|Participant Flow|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484355|NCT00700817|P4|Participant Flow|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484356|NCT00700817|P3|Participant Flow|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484357|NCT00700817|P2|Participant Flow|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484789|NCT00701064|O2|Outcome|Arm 2: Placebo Negative Ion Generator|"Negative Ion Generator (30 min/day)
Inactivated Negative Ion Generator: Administered via Negative Ion Generator"
484358|NCT00700817|P1|Participant Flow|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484359|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484360|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484361|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484362|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484363|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484364|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484365|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484756|NCT00701038|B2|Baseline|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
484366|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484367|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484368|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484369|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484370|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484371|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484372|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484373|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484374|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484375|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484376|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484377|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484461|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484378|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484379|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484380|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484381|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484382|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484383|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484384|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484385|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484386|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484751|NCT00700999|O2|Outcome|Combat Exposed Control|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD.
484387|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484388|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484389|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484390|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484391|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484392|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484393|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484394|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484395|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484396|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484397|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484566|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484398|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484399|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484400|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484401|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484402|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484403|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484404|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484405|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484406|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484407|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
496046|NCT00724984|P1|Participant Flow|Cohort 1(30mg/m2,5days/wk)/Phase 1|
484408|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484409|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484410|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484411|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484412|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484413|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484414|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484415|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484416|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484417|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484418|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484419|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484420|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484421|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484422|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484423|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484424|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484425|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484426|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484427|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484428|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
496047|NCT00724984|O2|Outcome|Mantle Cell Lymphoma/Phase II (Efficacy)|
484429|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484430|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484431|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484432|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484433|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484434|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484435|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484436|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484437|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484438|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484439|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484440|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484441|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484442|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484443|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484444|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484445|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484446|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484447|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484448|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484449|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
487024|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
484450|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484451|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484452|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484453|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484454|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484455|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484456|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484457|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484458|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484459|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484460|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484462|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484463|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484464|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484465|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484466|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484467|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484468|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484469|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484470|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
487025|NCT00704340|O2|Outcome|Control|Standard of Care (control)
484471|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484472|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484473|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484474|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484475|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484476|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484477|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484478|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484479|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484480|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484481|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484482|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484483|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484484|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484485|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484486|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484487|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484488|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484489|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484490|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484491|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484752|NCT00700999|O1|Outcome|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
484492|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484493|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484494|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484495|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484496|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484497|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484498|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484499|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484500|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484501|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484502|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484671|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484503|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484504|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484505|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484506|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484507|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484508|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484509|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484510|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484511|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484512|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
496048|NCT00724984|O1|Outcome|Follicular/Phase II (Efficacy)|
484513|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484514|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484515|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484516|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484517|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484518|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484519|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484520|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484521|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484522|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484523|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484524|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484525|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484526|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484527|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484528|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484529|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484530|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484531|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484532|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484533|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
496049|NCT00724984|O4|Outcome|Cohort 4(60 mg/m2, BID, 7days/wk)/Phase I|
484534|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484535|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484536|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484537|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484538|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484539|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484540|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484541|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484542|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484543|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484544|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484545|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484546|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484547|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484548|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484549|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484550|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484551|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484552|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484553|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484554|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
487026|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
484555|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484556|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484557|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484558|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484559|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484560|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484561|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484562|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484563|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484564|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484565|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484567|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484568|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484569|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484570|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484571|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484572|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484573|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484574|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484575|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
487027|NCT00704340|E2|Reported Event|Control|Standard of Care (control)
484576|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484577|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484578|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484579|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484580|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484581|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484582|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484583|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484584|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484585|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484586|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484587|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484588|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484589|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484590|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484591|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484592|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484593|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484594|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484595|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484596|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484753|NCT00700999|E2|Reported Event|Combat Exposed Controls|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
484597|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484598|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484599|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484600|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484601|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484602|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484603|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484604|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484605|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484606|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484607|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484734|NCT00700817|E3|Reported Event|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484608|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484609|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484610|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484611|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484612|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484613|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484614|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484615|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484616|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484617|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
496050|NCT00724984|O3|Outcome|Cohort 3(45 mg/m2, BID, 7days/wk)/Phase I|
484618|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484619|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484620|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484621|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484622|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484623|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484624|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484625|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484626|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484627|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484628|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484629|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484630|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484631|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484632|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484633|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484634|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484635|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484636|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484637|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484638|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
496051|NCT00724984|O2|Outcome|Cohort 2(45 mg/m2, BID, 5days/wk)/Phase I|
484639|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484640|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484641|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484642|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484643|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484644|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484645|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484646|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484647|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484648|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484649|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484650|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484651|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484652|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484653|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484654|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484655|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484656|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484657|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484658|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484659|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
487028|NCT00704340|E1|Reported Event|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
484660|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484661|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484662|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484663|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484664|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484665|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484666|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484667|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484668|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484669|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484670|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484672|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484673|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484674|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484675|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484676|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484677|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484678|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484679|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484680|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
487029|NCT00704353|B3|Baseline|Total|Total of all reporting groups
484681|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484682|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484683|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484684|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484685|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484686|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484687|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484688|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484689|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484690|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484691|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484692|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484693|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484694|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484695|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484696|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484697|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484698|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484699|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484700|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484701|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484754|NCT00700999|E1|Reported Event|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
484702|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484703|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484704|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484705|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484706|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484707|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484708|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484709|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484710|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484711|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484712|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484788|NCT00701064|P1|Participant Flow|Bright Light Exposure|"Bright Light (30 min/day)
Bright Light Exposure: Administered via bright light box"
485184|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
484713|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484714|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484715|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484716|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484717|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484718|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484719|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484720|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484721|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484722|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484755|NCT00701038|B3|Baseline|Total|Total of all reporting groups
484723|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484724|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484725|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484726|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484727|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484728|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484729|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
484730|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
484731|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
484732|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484733|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484735|NCT00700817|E2|Reported Event|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484736|NCT00700817|E1|Reported Event|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
484737|NCT00700973|B3|Baseline|Total|Total of all reporting groups
484738|NCT00700973|B2|Baseline|Arm 2|"Interpersonal violence prevention intervention
Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
484739|NCT00700973|B1|Baseline|Arm 1|"Substance use disorder usual care
Usual care: Substance use disorder usual care"
484740|NCT00700973|P2|Participant Flow|IPV-P|"Interpersonal violence prevention intervention
Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
484741|NCT00700973|P1|Participant Flow|Usual Care|"Substance use disorder usual care
Usual care: Substance use disorder usual care"
484742|NCT00700973|O2|Outcome|Arm 2|"Interpersonal violence prevention intervention
Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
484743|NCT00700973|O1|Outcome|Arm 1|"Substance use disorder usual care
Usual care: Substance use disorder usual care"
484744|NCT00700973|E2|Reported Event|Arm 2|"Interpersonal violence prevention intervention
Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
484745|NCT00700973|E1|Reported Event|Arm 1|"Substance use disorder usual care
Usual care: Substance use disorder usual care"
484746|NCT00700999|B3|Baseline|Total|Total of all reporting groups
484747|NCT00700999|B2|Baseline|Combat Exposed Controls|veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
484748|NCT00700999|B1|Baseline|Treatment Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
484749|NCT00700999|P2|Participant Flow|Combat Exposed Controls|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
484750|NCT00700999|P1|Participant Flow|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD. Completed 12 weeks of treatment with paroxetine (20-40mg QD)
484757|NCT00701038|B1|Baseline|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
484758|NCT00701038|P2|Participant Flow|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
484759|NCT00701038|P1|Participant Flow|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
484760|NCT00701038|O2|Outcome|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
484761|NCT00701038|O1|Outcome|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
484762|NCT00701038|E2|Reported Event|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
484763|NCT00701038|E1|Reported Event|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
484764|NCT00701051|B3|Baseline|Total|Total of all reporting groups
484765|NCT00701051|B2|Baseline|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
484766|NCT00701051|B1|Baseline|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
484767|NCT00701051|P3|Participant Flow|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance. Participants assigned to group after Period 1: Screening
484768|NCT00701051|P2|Participant Flow|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance. Participants assigned to group after Period 1: Screening
484769|NCT00701051|P1|Participant Flow|Older Adults|
484770|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
484771|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
484772|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
484773|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
484774|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
484775|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
484776|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
484777|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
484778|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
484779|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
484780|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
484781|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
484782|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
484783|NCT00701051|E1|Reported Event|Older Adults|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm); thus, data are reported for the entire group of participants.
484784|NCT00701064|B3|Baseline|Total|Total of all reporting groups
484785|NCT00701064|B2|Baseline|Negative Ion Generator|"Negative Ion Generator (30 min/day)
Negative Ion Generator: Administered via Negative Ion Generatore"
484786|NCT00701064|B1|Baseline|Bright Light Exposure|"Bright Light (30 min/day)
Bright Light Exposure: Administered via bright light box"
484787|NCT00701064|P2|Participant Flow|Negative Ion Generator|"Negative Ion Generator (30 min/day)
Negative Ion Generator: Administered via Negative Ion Generatore"
485381|NCT00694369|O2|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
484790|NCT00701064|O1|Outcome|Arm 1: Bright Light|"Bright Light (30 min/day)
Bright Light Exposure: Administered via bright light box"
484791|NCT00701064|E2|Reported Event|Arm 2: Negative Ion Generator|"Negative Ion Generator (30 min/day)
Negative Ion Generator: Administered via Negative Ion Generatore"
484792|NCT00701064|E1|Reported Event|Arm 1: Bright Light Exposure|"Bright Light (30 min/day)
Bright Light Exposure: Administered via bright light box"
484793|NCT00701090|B3|Baseline|Total|Total of all reporting groups
484794|NCT00701090|B2|Baseline|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484795|NCT00701090|B1|Baseline|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484796|NCT00701090|P2|Participant Flow|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484797|NCT00701090|P1|Participant Flow|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484798|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484799|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484800|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484837|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
484801|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484802|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484803|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484804|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484805|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484806|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484807|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484808|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484809|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484810|NCT00701090|E2|Reported Event|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484811|NCT00701090|E1|Reported Event|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
484812|NCT00701103|B12|Baseline|Total|Total of all reporting groups
484813|NCT00701103|B11|Baseline|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
484814|NCT00701103|B10|Baseline|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
484815|NCT00701103|B9|Baseline|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
484816|NCT00701103|B8|Baseline|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
484817|NCT00701103|B7|Baseline|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
484818|NCT00701103|B6|Baseline|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
484819|NCT00701103|B5|Baseline|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
484820|NCT00701103|B4|Baseline|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
484821|NCT00701103|B3|Baseline|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484822|NCT00701103|B2|Baseline|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484823|NCT00701103|B1|Baseline|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
484824|NCT00701103|P11|Participant Flow|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion 1 time every 3 weeks (Q3W).
484825|NCT00701103|P10|Participant Flow|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).
484826|NCT00701103|P9|Participant Flow|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
484827|NCT00701103|P8|Participant Flow|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
484828|NCT00701103|P7|Participant Flow|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
484829|NCT00701103|P6|Participant Flow|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
484830|NCT00701103|P5|Participant Flow|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
484831|NCT00701103|P4|Participant Flow|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
484832|NCT00701103|P3|Participant Flow|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484833|NCT00701103|P2|Participant Flow|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484834|NCT00701103|P1|Participant Flow|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).
484835|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
484836|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
484838|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
484839|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
484840|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
484841|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
484842|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
484843|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484844|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484845|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
484846|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
484847|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
484848|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
484849|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
484850|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
484851|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
484852|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
484853|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
484854|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484855|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484856|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
484857|NCT00701103|O7|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
484858|NCT00701103|O6|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.
484859|NCT00701103|O5|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg IV infusion Q1W.
484860|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg IV infusion Q1W.
484861|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484862|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484863|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
484864|NCT00701103|O7|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
484865|NCT00701103|O6|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.
484866|NCT00701103|O5|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg IV infusion Q1W.
484867|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg IV infusion Q1W.
484868|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484869|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484870|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
484871|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
484872|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
484873|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
484874|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
484875|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
484876|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
484877|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
484878|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
484879|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484880|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484881|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
484882|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
484883|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
484884|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
484885|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
484886|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
484979|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
484887|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
484888|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
484889|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
484890|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484891|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484892|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
484893|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
484894|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
484895|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
484896|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
484897|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
484898|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
484899|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
484900|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
484901|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484902|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484903|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
484904|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
484905|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
484906|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
484907|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
484908|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
484909|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
484910|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
484911|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
484912|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484913|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484914|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
484915|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
484916|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
484917|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
484918|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
484919|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
484920|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
484921|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
484922|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
484923|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484924|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484925|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
484926|NCT00701103|E11|Reported Event|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
484927|NCT00701103|E10|Reported Event|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
484928|NCT00701103|E9|Reported Event|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q1W.
484929|NCT00701103|E8|Reported Event|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
484930|NCT00701103|E7|Reported Event|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/mL) IV infusion Q1W.
484931|NCT00701103|E6|Reported Event|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
484932|NCT00701103|E5|Reported Event|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
484933|NCT00701103|E4|Reported Event|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
484934|NCT00701103|E3|Reported Event|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
484935|NCT00701103|E2|Reported Event|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
484936|NCT00701103|E1|Reported Event|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
484937|NCT00701129|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
484938|NCT00701129|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 milligrams per kilogram (mg/kg) intravenous (IV) infusion every other week (qow) (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was less than (<) 6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 milligrams per square meter (mg/m^2) (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
484939|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
484940|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
484941|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
484942|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
484943|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
484944|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
484980|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
484981|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
496052|NCT00724984|O1|Outcome|Cohort 1(30 mg/m2, BID, 5days/wk)/Phase I|
484945|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
484946|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
484947|NCT00701129|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
484948|NCT00701311|B1|Baseline|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
484949|NCT00701311|P1|Participant Flow|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
484950|NCT00701311|O1|Outcome|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
484951|NCT00701311|E1|Reported Event|Treatment Arm|Open label, one arm study.
484952|NCT00701363|B5|Baseline|Total|Total of all reporting groups
484953|NCT00701363|B4|Baseline|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
484954|NCT00701363|B3|Baseline|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
484955|NCT00701363|B2|Baseline|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
484956|NCT00701363|B1|Baseline|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject’s normal medical care, completing details of the injection in the diary cards provided.
484957|NCT00701363|P4|Participant Flow|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
484958|NCT00701363|P3|Participant Flow|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
484959|NCT00701363|P2|Participant Flow|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
484960|NCT00701363|P1|Participant Flow|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject’s normal medical care, completing details of the injection in the diary cards provided.
484961|NCT00701363|O1|Outcome|Overall Study|
484962|NCT00701363|O1|Outcome|Overall Study|Lanreotide Autogel 120 mg injections every 6 weeks, then depending on IGF-1 results at Week 24
484963|NCT00701363|O5|Outcome|Overall Study|
484964|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
484965|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
484966|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
484967|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
484968|NCT00701363|O1|Outcome|Overall Study|
484969|NCT00701363|O1|Outcome|Overall Study|
484970|NCT00701363|O5|Outcome|Overall Study|
484971|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
484972|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
484973|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
484974|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
484975|NCT00701363|O5|Outcome|Overall Study|
484976|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
484977|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
484978|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
484982|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
484983|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|Only 15 subjects participated only in phase 1 and did not move on to phase 2. The other entered in phase 2 according to IGF-1 level. Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
484984|NCT00701363|O1|Outcome|Overall Study|
484985|NCT00701363|O3|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
484986|NCT00701363|O2|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
484987|NCT00701363|O1|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
484988|NCT00701363|O3|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
484989|NCT00701363|O2|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
484990|NCT00701363|O1|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
484991|NCT00701363|O1|Outcome|Overall Study|
484992|NCT00701363|O1|Outcome|Overall Study|
484993|NCT00701363|O1|Outcome|Overall Study|
484994|NCT00701363|O1|Outcome|Overall Study|
484995|NCT00701363|E4|Reported Event|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
484996|NCT00701363|E3|Reported Event|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
484997|NCT00701363|E2|Reported Event|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
484998|NCT00701363|E1|Reported Event|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
484999|NCT00701389|B1|Baseline|All Enrolled Participants|All participants enrolled in the study
485000|NCT00701389|P4|Participant Flow|Sequence 4: D→A→B→C|Participants receive the following: Period 1: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D), Period 2: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treament A); Period 3: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 4: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C). Each dosing period is separated by a 5-day washout.
485001|NCT00701389|P3|Participant Flow|Sequence 3: C→B→A→D|Participants receive the following: Period 1 :single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C), Period 2: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 3: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A): Period 4: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D). Each dosing period is separated by a 5-day washout.
485382|NCT00694369|O1|Outcome|Placebo|Placebo orally once daily
485002|NCT00701389|P2|Participant Flow|Sequence 2: B→D→C→A|Participants receive the following: Period 1:single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 2: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D): Period 3: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 4:single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A). Each dosing period is separated by a 5-day washout.
485003|NCT00701389|P1|Participant Flow|Sequence 1: A→C→D→B|Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A); Period 2: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 3: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D); Period 4: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B). Each dosing period is separated by a 5-day washout.
485004|NCT00701389|O4|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of generic placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
485005|NCT00701389|O3|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of generic placebo/600 mg telcagepant in either Period 1, 2, 3, or 4 in the crossover
485006|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
485007|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
485008|NCT00701389|O4|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
485009|NCT00701389|O3|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
485010|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
485011|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
485012|NCT00701389|O2|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
485013|NCT00701389|O1|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
485014|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
485015|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
485016|NCT00701389|E4|Reported Event|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
485017|NCT00701389|E3|Reported Event|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
485018|NCT00701389|E2|Reported Event|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
485019|NCT00701389|E1|Reported Event|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
485020|NCT00701415|B3|Baseline|Total|Total of all reporting groups
485021|NCT00701415|B2|Baseline|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485022|NCT00701415|B1|Baseline|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485023|NCT00701415|P2|Participant Flow|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485024|NCT00701415|P1|Participant Flow|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485025|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485026|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485027|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485028|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485029|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485185|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485030|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485031|NCT00701415|E2|Reported Event|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485032|NCT00701415|E1|Reported Event|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
485033|NCT00701441|B3|Baseline|Total|Total of all reporting groups
485034|NCT00701441|B2|Baseline|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
485035|NCT00701441|B1|Baseline|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
485036|NCT00701441|P2|Participant Flow|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
485037|NCT00701441|P1|Participant Flow|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
485038|NCT00701441|O3|Outcome|Obstructive Sleep Apnea Post Treatment|Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(Stain Density Units)
485039|NCT00701441|O2|Outcome|Control|Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure(Stain Density Units)
485040|NCT00701441|O1|Outcome|Obstructive Sleep Apnea-pre Treatment|Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment(Stain Density Units)
485041|NCT00701441|O3|Outcome|Obstructive Sleep Apnea Post Treatment|Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(% dilation change from baseline)
485042|NCT00701441|O2|Outcome|Control|Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure
485043|NCT00701441|O1|Outcome|Obstructive Sleep Apnea-pre Treatment|Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment
485044|NCT00701441|E2|Reported Event|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
485045|NCT00701441|E1|Reported Event|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
485081|NCT00701675|P3|Participant Flow|Placebo|"matching placebo
Placebo 50 or 100 mg: matching placebo"
485082|NCT00701675|P2|Participant Flow|Sertraline 100mg|"sertraline 100mg per day
sertraline 100 mg daily: 100 mg daily"
485046|NCT00701558|B1|Baseline|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
485047|NCT00701558|P1|Participant Flow|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
485048|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
485049|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
485050|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
485051|NCT00701558|E1|Reported Event|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
485052|NCT00701636|B3|Baseline|Total|Total of all reporting groups
485053|NCT00701636|B2|Baseline|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
485054|NCT00701636|B1|Baseline|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
485055|NCT00701636|P2|Participant Flow|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
485056|NCT00701636|P1|Participant Flow|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
485057|NCT00701636|O1|Outcome|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis for CABG.
485186|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485058|NCT00701636|E2|Reported Event|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
485059|NCT00701636|E1|Reported Event|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
485060|NCT00701662|B1|Baseline|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485061|NCT00701662|P1|Participant Flow|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485062|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485063|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485064|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485065|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485066|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485067|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485068|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485069|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485070|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485071|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485072|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485073|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485074|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485075|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485076|NCT00701662|E1|Reported Event|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
485077|NCT00701675|B4|Baseline|Total|Total of all reporting groups
485078|NCT00701675|B3|Baseline|Placebo|"matching placebo
Placebo 50 or 100 mg: matching placebo"
485079|NCT00701675|B2|Baseline|Sertraline 100mg|"sertraline 100mg per day
sertraline 100 mg daily: 100 mg daily"
485080|NCT00701675|B1|Baseline|Sertraline 50mg|"sertraline 50mg per day
sertraline 50 mg daily: 50 mg daily"
485083|NCT00701675|P1|Participant Flow|Sertraline 50mg|"sertraline 50mg per day
sertraline 50 mg daily: 50 mg daily"
485084|NCT00701675|O3|Outcome|Placebo|"matching placebo
Placebo 50 or 100 mg: matching placebo"
485085|NCT00701675|O2|Outcome|Sertraline 100mg|"sertraline 100mg per day
sertraline 100 mg daily: 100 mg daily"
485086|NCT00701675|O1|Outcome|Sertraline 50mg|"sertraline 50mg per day
sertraline 50 mg daily: 50 mg daily"
485087|NCT00701675|E3|Reported Event|Placebo|"matching placebo
Placebo 50 or 100 mg: matching placebo"
485088|NCT00701675|E2|Reported Event|Sertraline 100mg|"sertraline 100mg per day
sertraline 100 mg daily: 100 mg daily"
485089|NCT00701675|E1|Reported Event|Sertraline 50mg|"sertraline 50mg per day
sertraline 50 mg daily: 50 mg daily"
485090|NCT00701727|B1|Baseline|Entire Study Population|Includes groups randomized to receive ezetimibe first and placebo first
485091|NCT00701727|P2|Participant Flow|Placebo First, Ezetimibe Second|Placebo first for 7 weeks,followed by ezetimibe for 7 weeks
485092|NCT00701727|P1|Participant Flow|Ezetimibe First, Placebo Second|Ezetimibe first for 7 weeks, followed by placebo for 7 weeks
485093|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
485094|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
485095|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
485096|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
485097|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
485098|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
485099|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
485100|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
485101|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
485102|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
485103|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
485104|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
485105|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
485106|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
485107|NCT00701727|E2|Reported Event|Ezetimibe|ezetimibe, 10 mg/day, for 7 weeks
485108|NCT00701727|E1|Reported Event|Placebo|Placebo, 10 mg/day, for 7 weeks
485109|NCT00701779|B1|Baseline|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.
Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
485121|NCT00701805|B2|Baseline|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
486655|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
485110|NCT00701779|P1|Participant Flow|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.
Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
485111|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.
Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
485112|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.
Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
485113|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.
Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
485114|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.
Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
485205|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
496053|NCT00724984|E6|Reported Event|Mantle Cell Lymphoma/Phase II|
485115|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.
Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
485116|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.
Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
485117|NCT00701779|E1|Reported Event|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.
Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
485118|NCT00701805|B5|Baseline|Total|Total of all reporting groups
485119|NCT00701805|B4|Baseline|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485120|NCT00701805|B3|Baseline|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485182|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485122|NCT00701805|B1|Baseline|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485123|NCT00701805|P4|Participant Flow|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485124|NCT00701805|P3|Participant Flow|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485125|NCT00701805|P2|Participant Flow|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485126|NCT00701805|P1|Participant Flow|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485127|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485206|NCT00701935|E2|Reported Event|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485207|NCT00701935|E1|Reported Event|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485208|NCT00694018|B3|Baseline|Total|Total of all reporting groups
485128|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485129|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485130|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485131|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485132|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485133|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485134|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485183|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485135|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485136|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485137|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485138|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485139|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485140|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485141|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485421|NCT00695019|P2|Participant Flow|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
485142|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485143|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485144|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485145|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485146|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485147|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485148|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485149|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485150|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485151|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485152|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485153|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485154|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485155|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
487100|NCT00704418|O1|Outcome|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
485156|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485157|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485158|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485159|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485160|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485161|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485162|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485163|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485164|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485165|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485166|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485167|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485168|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485169|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
487101|NCT00704418|O2|Outcome|Placebo|Placebo, dosed 1 drop daily
485170|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485171|NCT00701805|E4|Reported Event|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485172|NCT00701805|E3|Reported Event|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485173|NCT00701805|E2|Reported Event|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485174|NCT00701805|E1|Reported Event|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
485175|NCT00701935|B3|Baseline|Total|Total of all reporting groups
485176|NCT00701935|B2|Baseline|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485177|NCT00701935|B1|Baseline|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485178|NCT00701935|P2|Participant Flow|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485179|NCT00701935|P1|Participant Flow|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485180|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485181|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485187|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485188|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485189|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485190|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485191|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485192|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485193|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485194|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485195|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485196|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485197|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485198|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485199|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485200|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485201|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485202|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
485203|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
485204|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
496054|NCT00724984|E5|Reported Event|Follicular/Phase II|
485209|NCT00694018|B2|Baseline|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.
Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
485210|NCT00694018|B1|Baseline|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
485211|NCT00694018|P2|Participant Flow|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.
Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
485212|NCT00694018|P1|Participant Flow|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
485213|NCT00694018|O2|Outcome|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.
Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
485214|NCT00694018|O1|Outcome|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
485215|NCT00694018|E2|Reported Event|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.
Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
485216|NCT00694018|E1|Reported Event|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
485217|NCT00694070|B1|Baseline|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
485218|NCT00694070|P1|Participant Flow|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
485219|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
485220|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
485221|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
485222|NCT00694070|E1|Reported Event|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
485223|NCT00694096|B1|Baseline|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
485224|NCT00694096|P1|Participant Flow|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
485225|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
485226|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
485227|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
485383|NCT00694369|E5|Reported Event|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
485228|NCT00694096|E1|Reported Event|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
485229|NCT00694109|B1|Baseline|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485230|NCT00694109|P1|Participant Flow|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485231|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485232|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485233|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485234|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485235|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) once a week subcutaneously for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485236|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485237|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485238|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485239|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485240|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485241|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485242|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485243|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485244|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485245|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485246|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485247|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485248|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485249|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485250|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485251|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485252|NCT00694109|E1|Reported Event|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
485253|NCT00694122|B1|Baseline|All Study Participants|"Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied.
If the participant entered the study on NPH, NPH insulin given twice per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on once per day Lantus. Upon the second overnight visit, Lantus insulin and blood glucose outcomes was studied"
485254|NCT00694122|P2|Participant Flow|NPH First, Then Lantus|NPH was given twice per day in the first intervention period for 3-4 weeks and .Lantus was given once per day in second intervention period for 3-4 weeks.
485255|NCT00694122|P1|Participant Flow|Lantus First, Then NPH|Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied
485256|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
485257|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission. .
485258|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
485259|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
485260|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
485261|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given at 22:00 on the evening of the overnight admission.
485262|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
485263|NCT00694122|O1|Outcome|Glargine (Lantus)|glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
485264|NCT00694122|O2|Outcome|NPH Insulin|NPH was the given at 22:00 on the evening of the overnight admission.
485265|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
485266|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
496055|NCT00724984|E4|Reported Event|Cohort 4(60 mg/m2,7days/wk)/Phase I|
485267|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
485268|NCT00694122|E2|Reported Event|Lantus Insulin|Individuals on Lantus insulin as long acting insulin.
485269|NCT00694122|E1|Reported Event|NPH Insulin|Individuals on NPH insuling as long acting insulin.
485270|NCT00694161|B1|Baseline|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485271|NCT00694161|P1|Participant Flow|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485272|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485273|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485274|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485275|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485276|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485277|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485278|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
486830|NCT00703781|O2|Outcome|Placebo|Placebo, Dosed 1 Drop Daily
485279|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485280|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485281|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485282|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485283|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485284|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485285|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485422|NCT00695019|P1|Participant Flow|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
485286|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485287|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485288|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485289|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485290|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485291|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485292|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485293|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485294|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485295|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485296|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485297|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485298|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485299|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485300|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485301|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485302|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485423|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
496056|NCT00724984|E3|Reported Event|Cohort 3(45 mg/m2, 7days/wk)/Phase I|
485303|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485304|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485305|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485306|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485307|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485308|NCT00694161|E1|Reported Event|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
485309|NCT00694304|B1|Baseline|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485310|NCT00694304|P1|Participant Flow|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485311|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485312|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485313|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485314|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485315|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485316|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485317|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485318|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485319|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485320|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
485321|NCT00694304|E1|Reported Event|Vortioxetine 2.5, 5, or 10 mg/Day|
485322|NCT00694356|B4|Baseline|Total|Total of all reporting groups
485345|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485323|NCT00694356|B3|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485324|NCT00694356|B2|Baseline|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485325|NCT00694356|B1|Baseline|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485326|NCT00694356|P3|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485327|NCT00694356|P2|Participant Flow|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485328|NCT00694356|P1|Participant Flow|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by intravenous (IV) infusion once each week for up to 1 year or until participant withdraws consent, experiences an adverse event (AE), progressive disease or major protocol violation, has moved or is lost to follow up.
485329|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485330|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485331|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485332|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485424|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
496057|NCT00724984|E2|Reported Event|Cohort 2(45 mg/m2, 5days/wk)/Phase I|
485333|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485334|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485335|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485336|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485337|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485338|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485339|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485340|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485341|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485342|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485343|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485344|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
486881|NCT00703924|B3|Baseline|Total|Total of all reporting groups
485346|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485347|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485348|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485349|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485350|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485351|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485352|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485353|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485354|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485355|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485425|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
485356|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485357|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485358|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485359|NCT00694356|E3|Reported Event|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485360|NCT00694356|E2|Reported Event|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485361|NCT00694356|E1|Reported Event|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
485362|NCT00694369|B6|Baseline|Total|Total of all reporting groups
485363|NCT00694369|B5|Baseline|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
485364|NCT00694369|B4|Baseline|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
485365|NCT00694369|B3|Baseline|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
485366|NCT00694369|B2|Baseline|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
485367|NCT00694369|B1|Baseline|Placebo|Placebo orally once daily
485368|NCT00694369|P5|Participant Flow|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
485369|NCT00694369|P4|Participant Flow|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
485370|NCT00694369|P3|Participant Flow|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
485371|NCT00694369|P2|Participant Flow|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
485372|NCT00694369|P1|Participant Flow|Placebo|Placebo orally once daily
485373|NCT00694369|O5|Outcome|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
485374|NCT00694369|O4|Outcome|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
485375|NCT00694369|O3|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
485376|NCT00694369|O2|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
485377|NCT00694369|O1|Outcome|Placebo|Placebo orally once daily
485378|NCT00694369|O5|Outcome|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
485379|NCT00694369|O4|Outcome|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
485380|NCT00694369|O3|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
485384|NCT00694369|E4|Reported Event|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
485385|NCT00694369|E3|Reported Event|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
485386|NCT00694369|E2|Reported Event|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
485387|NCT00694369|E1|Reported Event|Placebo|Placebo orally once daily
485388|NCT00694551|B4|Baseline|Total|Total of all reporting groups
485389|NCT00694551|B3|Baseline|C. Peptide Vaccine|"Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485390|NCT00694551|B2|Baseline|B. Peptide Vaccine|"Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485391|NCT00694551|B1|Baseline|A. Peptide Vaccine|"Peptide vaccine dose Level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485392|NCT00694551|P3|Participant Flow|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485393|NCT00694551|P2|Participant Flow|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485394|NCT00694551|P1|Participant Flow|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485426|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
485395|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485396|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485397|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485398|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485399|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485400|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485401|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485402|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485403|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose Level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485404|NCT00694551|E3|Reported Event|C. Peptide Vaccine|"Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485405|NCT00694551|E2|Reported Event|B. Peptide Vaccine|"Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485406|NCT00694551|E1|Reported Event|A. Peptide Vaccine|"Peptide vaccine dose Level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
485407|NCT00694564|B1|Baseline|Sam-e (Treatment)|"This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.
S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
485408|NCT00694564|P1|Participant Flow|SAM-e|"This an open-labeled study. All participants will receive SAM-e.
S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
485409|NCT00694564|O1|Outcome|SAM-e|"This an open-labeled study. All participants will receive SAM-e.
S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
485410|NCT00694564|E1|Reported Event|Sam-e (Treatment)|"This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.
S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
485411|NCT00694603|B1|Baseline|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
485412|NCT00694603|P1|Participant Flow|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
485413|NCT00694603|O1|Outcome|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
485414|NCT00694603|O1|Outcome|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
485415|NCT00694603|E1|Reported Event|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
485416|NCT00695019|B4|Baseline|Total|Total of all reporting groups
485417|NCT00695019|B3|Baseline|Placebo|placebo lozenges taken 3 times per day
485418|NCT00695019|B2|Baseline|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
485419|NCT00695019|B1|Baseline|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
485420|NCT00695019|P3|Participant Flow|Placebo|placebo lozenges taken 3 times per day
485428|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
485429|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
485430|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
485431|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
485432|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
485433|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
485434|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
485435|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
485436|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
485437|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
485438|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
485439|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
485440|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
485441|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
485442|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
485443|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
485444|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
485445|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
485446|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
485447|NCT00695019|E3|Reported Event|Placebo|placebo lozenges taken 3 times per day
485448|NCT00695019|E2|Reported Event|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
485449|NCT00695019|E1|Reported Event|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
485450|NCT00695097|B3|Baseline|Total|Total of all reporting groups
485451|NCT00695097|B2|Baseline|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only followed up monthly for 1 year.
485452|NCT00695097|B1|Baseline|Rituximab Group|Rituximab Group: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15) and followed monthly for 1 year.
485453|NCT00695097|P2|Participant Flow|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only and being followed monthly for 1 year.
485454|NCT00695097|P1|Participant Flow|Rituximab Group|Rituximab Group: Rituximab dose is 1000 mg given as an IV infusion every 2 weeks (day 1 and 15) and followed monthly for 1 year.
485455|NCT00695097|O2|Outcome|Control Group|No Rituximab infusion
485456|NCT00695097|O1|Outcome|Rituximab Group|Rituximab infusion day 1 and 15
485457|NCT00695097|E2|Reported Event|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only.
485458|NCT00695097|E1|Reported Event|Rituximab Group|Rituximab Group: Rituximab infusion day 1 and day 14.
485459|NCT00695136|B1|Baseline|Open Label Single Arm|"Single group study of Donepezil
Increase REM sleep percentage :
Donepezil hydrochloride :"
485506|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
485507|NCT00695396|E3|Reported Event|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
485508|NCT00695396|E2|Reported Event|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
485509|NCT00695396|E1|Reported Event|Placebo|(1ml or 2 mL) subcutaneously once every week
485460|NCT00695136|P1|Participant Flow|Open Label Single Arm|"The children start by taking 1.25 mg of donepezil for 2 to 4 weeks. Those whose REM sleep increases to normal levels stay on 1.25 mg of donepezil for 8 more weeks. That ends their participation in the study.
Children whose REM sleep does not increase to normal on 1.25 mg of donepezil are given a higher dose (2.5 mg) for 2 to 4 weeks. Those whose REM sleep does not increase to normal on 2.5 mg of donepezil take 5 mg of the drug for 2 to 4 weeks. Children whose REM sleep does not increase to normal on 5 mg of donepezil stop the medication and end their participation in the study."
485461|NCT00695136|O1|Outcome|Open Label Single Arm|"Single group study of Donepezil
Increase REM sleep percentage :
Donepezil hydrochloride :"
485462|NCT00695136|E1|Reported Event|Open Label Single Arm|"Single group study of Donepezil
Increase REM sleep percentage :
Donepezil hydrochloride :"
485463|NCT00695188|B3|Baseline|Total|Total of all reporting groups
485464|NCT00695188|B2|Baseline|High Dose|Start with 25 mg MTX per week, administered orally
485465|NCT00695188|B1|Baseline|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
485466|NCT00695188|P2|Participant Flow|High Dose|Start with 25 mg MTX per week, administered orally
485467|NCT00695188|P1|Participant Flow|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
485468|NCT00695188|O2|Outcome|High Dose|Start with 25 mg MTX per week, administered orally
485469|NCT00695188|O1|Outcome|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
485470|NCT00695188|E2|Reported Event|High Dose|Start with 25 mg MTX per week, administered orally
485471|NCT00695188|E1|Reported Event|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
485472|NCT00695292|B1|Baseline|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
485473|NCT00695292|P1|Participant Flow|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
485474|NCT00695292|O1|Outcome|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
485475|NCT00695292|O1|Outcome|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
485537|NCT00695565|B2|Baseline|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
485538|NCT00695565|B1|Baseline|Placebo Gel|Placebo Gel is vehicle without clonidine
485476|NCT00695292|E1|Reported Event|Intervention|Patients in the study will receive the following for the duration of the study: irinotecan 60 mg/m2 intravenously on Days 1, 8, and 15 and carboplatin AUC=4 on Day 1. The study will consist of 28-day cycles, to a maximum of 6 cycles of therapy with irinotecan and carboplatin. After treatment with irinotecan and carboplatin, sunitinib will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During sunitinib maintenance therapy, patients will receive sunitinib at 25 mg orally daily. Sunitinib maintenance therapy will continue until progressive disease or irreversible toxicity occurs.
485477|NCT00695318|B3|Baseline|Total|Total of all reporting groups
485478|NCT00695318|B2|Baseline|A, 2, II 0.5 µg/Day + Sham|"0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/Day + Sham treatment in fellow eye"
485479|NCT00695318|B1|Baseline|A, 2, I 0.2 µg/Day + Sham|"0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/Day + Sham treatment in fellow eye"
485480|NCT00695318|P2|Participant Flow|A, 2, II 0.5 µg/Day + Sham|"0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/Day"
485481|NCT00695318|P1|Participant Flow|A, 2, I 0.2 µg/Day + Sham|"0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/Day"
485482|NCT00695318|O4|Outcome|A, 2, II 0.5 µg/Day|"0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/Day"
485483|NCT00695318|O3|Outcome|A, 2, II Sham|
485484|NCT00695318|O2|Outcome|A, 2, I 0.2 µg/Day|"0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/Day"
485485|NCT00695318|O1|Outcome|A, 2, I Sham|
485486|NCT00695318|E5|Reported Event|0.5 ug/Day + Sham Injection|"Fluocinolone Acetonide: 0.5 µg/Day + Sham Injection
Systemic AEs"
485487|NCT00695318|E4|Reported Event|0.2 ug/Day + Sham Injection|"Fluocinolone Acetonide: 0.2 µg/Day + Sham Injection
Systemic AEs"
485488|NCT00695318|E3|Reported Event|0.5 ug/Day|"0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/Day
Ocular AEs"
485489|NCT00695318|E2|Reported Event|0.2 ug/Day|"0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/Day
Ocular AEs"
485490|NCT00695318|E1|Reported Event|Sham Injection|"Sham Injection
Sham Injection: Sham injection
Ocular AEs"
485491|NCT00695396|B4|Baseline|Total|Total of all reporting groups
485492|NCT00695396|B3|Baseline|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
485493|NCT00695396|B2|Baseline|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
485494|NCT00695396|B1|Baseline|Placebo|(1ml or 2 mL) subcutaneously once every week
485495|NCT00695396|P3|Participant Flow|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
485496|NCT00695396|P2|Participant Flow|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
485497|NCT00695396|P1|Participant Flow|Placebo|(1ml or 2 mL) subcutaneously once every week
485498|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
485499|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
485500|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
485501|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
485502|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
485503|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
485504|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
485505|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
485511|NCT00695435|P3|Participant Flow|TOBREX, Then TOBRADEX, Then Tob 0.3%/Dex 0.05%|Patients received TOBREX first, then TOBRADEX, then Tob 0.3%/Dex 0.05%
485512|NCT00695435|P2|Participant Flow|Tob 0.3%/Dex 0.05%, Then TOBREX, Then TOBRADEX|Patients received Tob 0.3%/Dex 0.05% first, then TOBREX, then TOBRADEX
485513|NCT00695435|P1|Participant Flow|TOBRADEX, Then Tob 0.3%/Dex 0.05%, Then TOBREX|Patients received TOBRADEX first, then Tob 0.3%/Dex 0.05%, then TOBREX
485514|NCT00695435|O3|Outcome|TOBRADEX® Ophthalmic Suspension|TOBRADEX® Ophthalmic Suspension
485515|NCT00695435|O2|Outcome|TOBREX® Ophthalmic Solution|TOBREX® Ophthalmic Solution
485516|NCT00695435|O1|Outcome|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
485517|NCT00695435|O3|Outcome|TOBRADEX® Ophthalmic Suspension|TOBRADEX® Ophthalmic Suspension
485518|NCT00695435|O2|Outcome|TOBREX® Ophthalmic Solution|TOBREX® Ophthalmic Solution
485519|NCT00695435|O1|Outcome|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
485520|NCT00695435|E3|Reported Event|TOBRADEX®|TOBRADEX® Ophthalmic Suspension
485521|NCT00695435|E2|Reported Event|TOBREX®|TOBREX® Ophthalmic Solution
485522|NCT00695435|E1|Reported Event|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
485523|NCT00695500|B3|Baseline|Total|Total of all reporting groups
485524|NCT00695500|B2|Baseline|Placebo|Placebo tablets, 0 mg per day for 3 weeks
485525|NCT00695500|B1|Baseline|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
485526|NCT00695500|P2|Participant Flow|Placebo|Placebo tablets, 0 mg per day for 3 weeks
485527|NCT00695500|P1|Participant Flow|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
485528|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
485529|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
485530|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
485531|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
485532|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
485533|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
485534|NCT00695500|E2|Reported Event|Placebo|Placebo tablets, 0 mg per day for 3 weeks
485535|NCT00695500|E1|Reported Event|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
485539|NCT00695565|P2|Participant Flow|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
485540|NCT00695565|P1|Participant Flow|Placebo Gel|Placebo Gel is vehicle without clonidine
485541|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485542|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485543|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485544|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485545|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485546|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485547|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485548|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485549|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485550|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485551|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485552|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485553|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485554|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485555|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485556|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485557|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485558|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485559|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485560|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485561|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485562|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485563|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485564|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485565|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485566|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485567|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485568|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
485569|NCT00695565|E2|Reported Event|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
485570|NCT00695565|E1|Reported Event|Placebo Gel|Placebo Gel is vehicle without clonidine
485571|NCT00695669|B5|Baseline|Total|Total of all reporting groups
485572|NCT00695669|B4|Baseline|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485573|NCT00695669|B3|Baseline|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485574|NCT00695669|B2|Baseline|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485575|NCT00695669|B1|Baseline|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485703|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
496058|NCT00724984|E1|Reported Event|Cohort 1(30 mg/m2, 5days/wk)/Phase I|
485576|NCT00695669|P4|Participant Flow|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485577|NCT00695669|P3|Participant Flow|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485578|NCT00695669|P2|Participant Flow|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485579|NCT00695669|P1|Participant Flow|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485580|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485581|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485582|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485583|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485584|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485585|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485586|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485587|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485588|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485589|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485590|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485591|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485592|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485593|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485594|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485595|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485596|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485597|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485598|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485761|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485599|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485600|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485601|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485602|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485603|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485604|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485605|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485606|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485607|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485608|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485609|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485610|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485611|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485612|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485613|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485614|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485615|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485616|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485617|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485618|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485619|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485620|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485621|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485866|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485622|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485623|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485624|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485625|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485626|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485627|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485628|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485629|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485630|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485631|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485632|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485633|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485634|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485635|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485636|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485637|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485638|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485639|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485640|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485641|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485642|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485643|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485644|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485867|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485645|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485646|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485647|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485648|NCT00695669|E4|Reported Event|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
485649|NCT00695669|E3|Reported Event|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
485650|NCT00695669|E2|Reported Event|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
485651|NCT00695669|E1|Reported Event|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
485652|NCT00695864|B1|Baseline|Placebo Then Ondansetron|"Dosage and form:
Placebo - tablet Odansetron - 8 mg oral tablet
Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron."
485653|NCT00695864|P1|Participant Flow|Placebo Then Ondansetron|"Dosage and form:
Placebo - tablet Odansetron - 8 mg oral tablet
Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron."
485654|NCT00695864|O2|Outcome|Ondansetron|"Ondansetron
Ondansetron and Placebo crossover"
485655|NCT00695864|O1|Outcome|Placebo - Sugar Pill|"Placebo - sugar pill
Ondansetron and Placebo crossover"
485656|NCT00695864|E2|Reported Event|Ondansetron|"Ondansetron
Ondansetron and Placebo crossover"
485657|NCT00695864|E1|Reported Event|Placebo - Sugar Pill|"Placebo - sugar pill
Ondansetron and Placebo crossover"
485658|NCT00695903|B3|Baseline|Total|Total of all reporting groups
485659|NCT00695903|B2|Baseline|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
485660|NCT00695903|B1|Baseline|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
485661|NCT00695903|P2|Participant Flow|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
485662|NCT00695903|P1|Participant Flow|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
485663|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
485664|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
485665|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
485666|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
485667|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
485668|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
485669|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
485670|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
485671|NCT00695903|E2|Reported Event|Vancomycin|Vancomycin 15 mg/kg i.v., dosed to maintain trough serum concentrations of 15 to 20 ug/mL
485672|NCT00695903|E1|Reported Event|Daptomycin|Daptomycin 10 mg/kg i.v.q24hr
485673|NCT00695955|B1|Baseline|Azilsartan Medoxomil|"Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved."
485674|NCT00695955|P1|Participant Flow|Azilsartan Medoxomil|"Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved."
485675|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
485676|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
485677|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
485678|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
485679|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
485680|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
485681|NCT00695955|E2|Reported Event|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
485682|NCT00695955|E1|Reported Event|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
485683|NCT00696020|B5|Baseline|Total|Total of all reporting groups
485684|NCT00696020|B4|Baseline|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485685|NCT00696020|B3|Baseline|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485686|NCT00696020|B2|Baseline|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485687|NCT00696020|B1|Baseline|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485688|NCT00696020|P4|Participant Flow|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485689|NCT00696020|P3|Participant Flow|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485690|NCT00696020|P2|Participant Flow|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485840|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485691|NCT00696020|P1|Participant Flow|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485692|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485693|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485694|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485695|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485696|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485697|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485698|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485699|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485700|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485701|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485702|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
487102|NCT00704418|O1|Outcome|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
485704|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485705|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485706|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485707|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485708|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485709|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485710|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485711|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485712|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485713|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485714|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485715|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485716|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485717|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485718|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485719|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
486227|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks
placebo :"
485720|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485721|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485722|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485723|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485724|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485725|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485726|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485727|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485728|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485729|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485730|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485731|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485868|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
487103|NCT00704418|E2|Reported Event|Placebo|Placebo, dosed 1 drop daily
485732|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485733|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485734|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485735|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485736|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485737|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485738|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485739|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485740|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485741|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485742|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485743|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485744|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485745|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485746|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485747|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485841|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485748|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485749|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485750|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485751|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485752|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485753|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485754|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485755|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485756|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485757|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485758|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485759|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485760|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485869|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485762|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485763|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485764|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485765|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485766|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485767|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485768|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485769|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485770|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485771|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485772|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485773|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485774|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485775|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485776|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485777|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485778|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485779|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485780|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485781|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485782|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485783|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485784|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485785|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485786|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485787|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485788|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485789|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485790|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
487104|NCT00704418|E1|Reported Event|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
485791|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485792|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485793|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485794|NCT00696020|E4|Reported Event|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485795|NCT00696020|E3|Reported Event|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485796|NCT00696020|E2|Reported Event|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485797|NCT00696020|E1|Reported Event|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
485798|NCT00696072|B3|Baseline|Total|Total of all reporting groups
485799|NCT00696072|B2|Baseline|Letrozole|Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
485800|NCT00696072|B1|Baseline|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years
Dasatinib 100 mg + Letrozole 2.5 mg"
485801|NCT00696072|P2|Participant Flow|Letrozole|Participants received letrozole 2.5 mg tablets, once daily, up to 2 years. If the participant developed progressive disease while on the single agent, the participant had the option to add dasatinib to their treatment regimen.
485802|NCT00696072|P1|Participant Flow|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years
Dasatinib 100 mg + Letrozole 2.5 mg Tablets, once daily up to 2 years. If a participant experienced intolerable toxicity related to dasatinib, they had the option to crossover to letrozole arm."
485803|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
485804|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years
Dasatinib 100 mg + Letrozole 2.5 mg
Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
485805|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
485842|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
487740|NCT00705367|E1|Reported Event|Abatacept 30 mg/kg|
485806|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years
Dasatinib 100 mg + Letrozole 2.5 mg
Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
485807|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
485808|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years
Dasatinib 100 mg + Letrozole 2.5 mg
Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
485809|NCT00696072|O1|Outcome|Crossed Over From Letrozole to Letrozole + Dasatinib|These participants were randomized to receive letrozole 2.5 mg PO once daily. After developing progressive disease they continued letrozole, and were permitted to add 100 mg PO once daily dasatinib to their treatment regimen.
485810|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
485811|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years
Dasatinib 100 mg + Letrozole 2.5 mg
Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
485812|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
485813|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years
Dasatinib 100 mg + Letrozole 2.5 mg
Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
485814|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
485870|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485871|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485815|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years
Dasatinib 100 mg + Letrozole 2.5 mg
Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
485816|NCT00696072|E2|Reported Event|Letrozole|Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
485817|NCT00696072|E1|Reported Event|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years
Dasatinib 100 mg + Letrozole 2.5 mg"
485818|NCT00696241|B6|Baseline|Total|Total of all reporting groups
485819|NCT00696241|B5|Baseline|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485820|NCT00696241|B4|Baseline|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485821|NCT00696241|B3|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485822|NCT00696241|B2|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485823|NCT00696241|B1|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485824|NCT00696241|P5|Participant Flow|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485825|NCT00696241|P4|Participant Flow|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485826|NCT00696241|P3|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485827|NCT00696241|P2|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485828|NCT00696241|P1|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485829|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485830|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485831|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485832|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485833|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485834|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485835|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485836|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485837|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485838|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485839|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485843|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485844|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485845|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485846|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485847|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485848|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485849|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485850|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485851|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485852|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485853|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485854|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485855|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485856|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485857|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485858|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485859|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485860|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485861|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485862|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485863|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485864|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485865|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485872|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485873|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485874|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485875|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485876|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485877|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485878|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485879|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485880|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485881|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485882|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485883|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485884|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485885|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485886|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485887|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485888|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485889|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485890|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485891|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485892|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485893|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485894|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485895|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485896|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485897|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485898|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485899|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485900|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485901|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485902|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485903|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485904|NCT00696241|E5|Reported Event|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
485905|NCT00696241|E4|Reported Event|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
485906|NCT00696241|E3|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
485907|NCT00696241|E2|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
485908|NCT00696241|E1|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
485909|NCT00696293|B1|Baseline|Duloxetine Plus Clinical Management|"Duloxetine + clinical management
Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
485910|NCT00696293|P1|Participant Flow|Duloxetine Plus Clinical Management|"Duloxetine + clinical management
Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
485911|NCT00696293|O1|Outcome|Duloxetine + Clinical Management|"Duloxetine + clinical management
NOTE -- THIS WORK WAS CONDUCTED AS PART OF A CAREER DEVELOPMENT AWARD. THE CLINICALTRIALS.GOV DESCRIPTION OF THE STUDY WAS UPDATED 1/5/16 TO UPDATE THE OPEN LABEL NATURE OF THIS WORK. THIS IS WHAT IS REPORTED HERE AND HAS BEEN PEER REVIEWED AND PUBLISHED.
Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
485912|NCT00696293|O1|Outcome|Duloxetine Plus Clinical Management|"Duloxetine + clinical management
Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
485913|NCT00696293|E1|Reported Event|Duloxetine Plus Clinical Management|"Duloxetine + clinical management
Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
485914|NCT00696384|B1|Baseline|Azilsartan Medoxomil QD - Open Label Phase|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks. Study medication could have been up-titrated only after participant had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up or down-titrated by 1 dose level per scheduled or unscheduled visit. Baseline characteristics of this Open Label phase population are described in the table below.
485915|NCT00696384|P3|Participant Flow|Placebo QD - Double-Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg, orally once daily or other non-ARB antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
485916|NCT00696384|P2|Participant Flow|Azilsartan Medoxomil QD - Double-Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking), for 6 weeks.
485917|NCT00696384|P1|Participant Flow|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.
Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
485918|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
485919|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
485920|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed and other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.
Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
485921|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.
Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
485922|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.
Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
487741|NCT00705406|B3|Baseline|Total|Total of all reporting groups
485923|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
485924|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
485925|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
485926|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
485927|NCT00696384|E3|Reported Event|Placebo QD - Double-Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for up to 6 weeks.
485928|NCT00696384|E2|Reported Event|Azilsartan Medoxomil QD - Double-Blind Reversal Phase|Azilsartan medoxomil current dose (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other antihypertensive medications as needed for 6 weeks.
485929|NCT00696384|E1|Reported Event|Azilsartan Medoxomil QD - Open Label|"Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, titrated to 80 mg, tablets, orally, once daily.. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.
Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
485930|NCT00696423|B3|Baseline|Total|Total of all reporting groups
485931|NCT00696423|B2|Baseline|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485932|NCT00696423|B1|Baseline|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485933|NCT00696423|P2|Participant Flow|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485974|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
485934|NCT00696423|P1|Participant Flow|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485935|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485936|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485937|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485938|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485939|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485940|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485941|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485942|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485943|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485944|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485945|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485946|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485947|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485948|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485949|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485950|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485951|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485952|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485953|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485954|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485955|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485956|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485957|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485958|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485959|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485960|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485961|NCT00696423|E2|Reported Event|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
485962|NCT00696423|E1|Reported Event|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
485963|NCT00696436|B6|Baseline|Total|Total of all reporting groups
485964|NCT00696436|B5|Baseline|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
485965|NCT00696436|B4|Baseline|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
485966|NCT00696436|B3|Baseline|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
485967|NCT00696436|B2|Baseline|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
485968|NCT00696436|B1|Baseline|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
485969|NCT00696436|P5|Participant Flow|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
485970|NCT00696436|P4|Participant Flow|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
485971|NCT00696436|P3|Participant Flow|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
485972|NCT00696436|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
485973|NCT00696436|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
487105|NCT00704522|B3|Baseline|Total|Total of all reporting groups
485975|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
485976|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
485977|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
485978|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
485979|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
485980|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
485981|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
485982|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
485983|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
485984|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
485985|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
485986|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
485987|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
485988|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
485989|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
485990|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486176|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
485991|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
485992|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
485993|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
485994|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
485995|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
485996|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
485997|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
485998|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
485999|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
486000|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486001|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
486002|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
486003|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
486004|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
487145|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
486005|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486006|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
486007|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
486008|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
486009|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
486010|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486011|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
486012|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
486013|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
486014|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
486015|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486016|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
486017|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
486018|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
486019|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
486020|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486021|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
486022|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
486023|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
486024|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
486025|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486026|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
486027|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
486028|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
486029|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
486030|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486031|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
486032|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
486033|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
486034|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
496278|NCT00725361|O1|Outcome|Active|"Ambrisentan
Ambrisentan"
486035|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486036|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
486037|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
486038|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
486039|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
486040|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486041|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
486042|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
486043|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
486044|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
486045|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486046|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
486047|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
486048|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
486049|NCT00696436|E5|Reported Event|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
486050|NCT00696436|E4|Reported Event|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
486051|NCT00696436|E3|Reported Event|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
486052|NCT00696436|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
486053|NCT00696436|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
486054|NCT00696449|B5|Baseline|Total|Total of all reporting groups
486055|NCT00696449|B4|Baseline|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
486056|NCT00696449|B3|Baseline|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
486057|NCT00696449|B2|Baseline|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
486058|NCT00696449|B1|Baseline|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
486059|NCT00696449|P4|Participant Flow|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
486060|NCT00696449|P3|Participant Flow|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
486061|NCT00696449|P2|Participant Flow|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
486062|NCT00696449|P1|Participant Flow|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
486063|NCT00696449|O4|Outcome|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
486064|NCT00696449|O3|Outcome|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
486065|NCT00696449|O2|Outcome|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
486066|NCT00696449|O1|Outcome|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
486067|NCT00696449|E4|Reported Event|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
486068|NCT00696449|E3|Reported Event|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
486069|NCT00696449|E2|Reported Event|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
486070|NCT00696449|E1|Reported Event|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
486071|NCT00696488|B1|Baseline|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions
Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
486104|NCT00702221|O1|Outcome|Angiotensin Therapeutic Vaccine + CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)
Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
486220|NCT00702364|B3|Baseline|Total|Total of all reporting groups
486072|NCT00696488|P1|Participant Flow|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions
Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
486073|NCT00696488|O1|Outcome|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions
Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
486074|NCT00696488|E1|Reported Event|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions
Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
486075|NCT00702143|B4|Baseline|Total|Total of all reporting groups
486076|NCT00702143|B3|Baseline|Healthy Controls|cognitively normal (healthy) controls
486077|NCT00702143|B2|Baseline|MCI Subjects|MCI (mild cognitive impairment)
486078|NCT00702143|B1|Baseline|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
486079|NCT00702143|P3|Participant Flow|Healthy Controls|cognitively normal (healthy) controls
486080|NCT00702143|P2|Participant Flow|MCI Subjects|MCI (mild cognitive impairment)
486081|NCT00702143|P1|Participant Flow|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
486082|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
486083|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
486084|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
486085|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
486086|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
486087|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
486088|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
486089|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
486090|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
486091|NCT00702143|E1|Reported Event|All Subjects|All subjects receiving florbetapir F 18 injection
486092|NCT00702208|B1|Baseline|Single Arm Study|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
486093|NCT00702208|P1|Participant Flow|Single Arm Study of Delphi Screener|"Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room."
486094|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|"Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room."
486095|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
486096|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
486097|NCT00702208|E1|Reported Event|Single Arm Study|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
486098|NCT00702221|B3|Baseline|Total|Total of all reporting groups
486099|NCT00702221|B2|Baseline|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone
CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
486100|NCT00702221|B1|Baseline|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)
Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
486101|NCT00702221|P2|Participant Flow|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone
CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
486102|NCT00702221|P1|Participant Flow|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)
Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
486103|NCT00702221|O2|Outcome|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone
CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
486105|NCT00702221|E2|Reported Event|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone
CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
492763|NCT00716742|P3|Participant Flow|Xalatan®|latanoprost 0.005%
486106|NCT00702221|E1|Reported Event|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)
Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
486107|NCT00702234|B1|Baseline|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
486108|NCT00702234|P2|Participant Flow|Fetuses Present at 10 Weeks After Fresh ET in Base Study|This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
486109|NCT00702234|P1|Participant Flow|Women/Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
486110|NCT00702234|O1|Outcome|Live Born Infants|This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.
486145|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
488138|NCT00708942|B4|Baseline|Arm 4: HAL Ointment, LED Diode Illumination|
486111|NCT00702234|O1|Outcome|Live Born Infants|This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.
486112|NCT00702234|O1|Outcome|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
486113|NCT00702234|O1|Outcome|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
486114|NCT00702234|O1|Outcome|Women - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
486115|NCT00702234|E2|Reported Event|Fetuses Present at 10 Weeks After Fresh ET in Base Study|This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
486221|NCT00702364|B2|Baseline|Placebo|"Placebo twice a day for two weeks
placebo :"
486116|NCT00702234|E1|Reported Event|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
486117|NCT00702273|B3|Baseline|Total|Total of all reporting groups
486118|NCT00702273|B2|Baseline|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486119|NCT00702273|B1|Baseline|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486120|NCT00702273|P2|Participant Flow|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486146|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
486147|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
486121|NCT00702273|P1|Participant Flow|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent frozen thawed embryo transfer (FTET) cycles.
486122|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486123|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486124|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486172|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486173|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486174|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486175|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486125|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486126|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486127|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486128|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486129|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486148|NCT00702299|E1|Reported Event|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60–1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
486149|NCT00702325|B3|Baseline|Total|Total of all reporting groups
486150|NCT00702325|B2|Baseline|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486130|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486131|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486132|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486133|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
492764|NCT00716742|P2|Participant Flow|Travatan®|travoprost 0.004%
486134|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486135|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486136|NCT00702273|E2|Reported Event|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486137|NCT00702273|E1|Reported Event|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
486138|NCT00702299|B1|Baseline|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60–1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
486139|NCT00702299|P1|Participant Flow|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
486140|NCT00702299|O3|Outcome|Pemetrexed Dose 1,000mg/m2|Level 5 Pemetrexed dose 1,000mg/m2
486141|NCT00702299|O2|Outcome|Pemetrexed Dose 750 mg/m2|Level 4 Pemetrexed dose 750 mg/m2
486142|NCT00702299|O1|Outcome|Pemetrexed Dose 500mg/m2|Level 3 Pemetrexed dose 500mg/m2
486143|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
486144|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
486151|NCT00702325|B1|Baseline|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486152|NCT00702325|P2|Participant Flow|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486153|NCT00702325|P1|Participant Flow|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486154|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486155|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486156|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486157|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486158|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486159|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486160|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486161|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486162|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486163|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486164|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486165|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486166|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486167|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486168|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486169|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486170|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486171|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486177|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486178|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486179|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486180|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486181|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486182|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486183|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486184|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486185|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486186|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486187|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486188|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486189|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486190|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486191|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486192|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486193|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486194|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486195|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486196|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486197|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486198|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486199|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486200|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486201|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486202|NCT00702325|E2|Reported Event|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
486203|NCT00702325|E1|Reported Event|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
486204|NCT00702338|B1|Baseline|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
486205|NCT00702338|P3|Participant Flow|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
486206|NCT00702338|P2|Participant Flow|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
486207|NCT00702338|P1|Participant Flow|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
486208|NCT00702338|O1|Outcome|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers from study P05693 (NCT00697255) were followed for safety and efficacy on the current study according to standard practice.
486209|NCT00702338|O1|Outcome|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
486222|NCT00702364|B1|Baseline|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks
atomoxetine :"
486223|NCT00702364|P2|Participant Flow|Placebo|"Placebo twice a day for two weeks
placebo :"
486224|NCT00702364|P1|Participant Flow|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks
atomoxetine :"
486225|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks
placebo :"
486226|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks
atomoxetine :"
486210|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
486211|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
486212|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
486213|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
486214|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
486249|NCT00702403|P1|Participant Flow|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
486325|NCT00702884|O1|Outcome|Grade 1 and 2 Adverse Events|"Grade 1=Mild; asymptomatic or mild symptoms
Grade 2=Moderate; minimal, local or noninvasive intervention indicated"
486215|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
486216|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
486217|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
486218|NCT00702338|E2|Reported Event|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
486219|NCT00702338|E1|Reported Event|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
486228|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks
atomoxetine :"
486229|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks
placebo :"
486230|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks
atomoxetine :"
486231|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks
placebo :"
486232|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks
atomoxetine :"
486233|NCT00702364|E2|Reported Event|Placebo|"Placebo twice a day for two weeks
placebo :"
486234|NCT00702364|E1|Reported Event|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks
atomoxetine :"
486235|NCT00702377|B3|Baseline|Total|Total of all reporting groups
486236|NCT00702377|B2|Baseline|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486237|NCT00702377|B1|Baseline|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486238|NCT00702377|P2|Participant Flow|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486239|NCT00702377|P1|Participant Flow|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486240|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486241|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486242|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486243|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486244|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486245|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486246|NCT00702377|E2|Reported Event|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486247|NCT00702377|E1|Reported Event|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
486248|NCT00702403|B1|Baseline|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
486319|NCT00702884|B1|Baseline|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle
sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
486320|NCT00702884|P1|Participant Flow|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle
sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
486250|NCT00702403|O1|Outcome|Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
486251|NCT00702403|O1|Outcome|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood counts recover (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood counts recover until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
486252|NCT00702403|O1|Outcome|Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)|"Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
nilotinib: Given PO
imatinib mesylate: Given PO
pharmacological study: Correlative studies"
486253|NCT00702403|O1|Outcome|Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
486254|NCT00702403|O1|Outcome|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
486255|NCT00702403|E1|Reported Event|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
486256|NCT00702754|B1|Baseline|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
486257|NCT00702754|P1|Participant Flow|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
486258|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
486653|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
486259|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
486260|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
486261|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
486262|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
486263|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
486264|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
486265|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
486266|NCT00702754|E1|Reported Event|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
486267|NCT00702780|B3|Baseline|Total|Total of all reporting groups
486268|NCT00702780|B2|Baseline|Placebo|placebo 20mg qd
486269|NCT00702780|B1|Baseline|Escitalopram|escitalopram 20mg qd
486270|NCT00702780|P2|Participant Flow|Placebo|placebo 20mg qd
486271|NCT00702780|P1|Participant Flow|Escitalopram|escitalopram 20mg qd
486272|NCT00702780|O2|Outcome|Placebo|placebo 20mg qd
486273|NCT00702780|O1|Outcome|Escitalopram|escitalopram 20mg qd
486274|NCT00702780|O2|Outcome|Placebo|placebo 20mg qd
486275|NCT00702780|O1|Outcome|Escitalopram|escitalopram 20mg qd
486276|NCT00702780|E2|Reported Event|Placebo|Placebo 20mg qd
486277|NCT00702780|E1|Reported Event|Escitalopram|Escitalopram 20mg qd
486278|NCT00702845|B3|Baseline|Total|Total of all reporting groups
486279|NCT00702845|B2|Baseline|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486280|NCT00702845|B1|Baseline|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486281|NCT00702845|P2|Participant Flow|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486282|NCT00702845|P1|Participant Flow|100 μg Corifollitropin Alfa|Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
486283|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486284|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486346|NCT00702949|P1|Participant Flow|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
486285|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486286|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486287|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486288|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486321|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle
sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
486322|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle
sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
486323|NCT00702884|O3|Outcome|Grade 4 Adverse Events|Grade 4=Life-threatening consequences; urgent intervention indicated
486324|NCT00702884|O2|Outcome|Grade 3 Adverse Events|Grade 3=Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated
486289|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486290|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486291|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486292|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486293|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486347|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
486654|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
486294|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486295|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486296|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486297|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486298|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
487712|NCT00705341|E1|Reported Event|Low Dose for phase1|4 weeks of Fluticasone (Flovent diskus) 250 mcg twice daily (500 mcg/day)
486299|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486300|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486301|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486302|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486303|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486304|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486305|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486306|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486307|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486308|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
487713|NCT00705367|B3|Baseline|Total|Total of all reporting groups
486309|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486310|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486311|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486312|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486313|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486314|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486315|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486316|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
486317|NCT00702845|E2|Reported Event|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
486318|NCT00702845|E1|Reported Event|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
487714|NCT00705367|B2|Baseline|Placebo|Infusion, Intravenous, single dose, 24 hours
486326|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle
sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
486327|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle
sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
486328|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle
sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
486329|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle
sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
486330|NCT00702884|E1|Reported Event|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle
sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
486331|NCT00702923|B1|Baseline|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
486332|NCT00702923|P1|Participant Flow|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
486333|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
486334|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
486335|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
486336|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
486337|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
486338|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
486339|NCT00702923|E1|Reported Event|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
486340|NCT00702949|B4|Baseline|Total|Total of all reporting groups
486341|NCT00702949|B3|Baseline|Placebo|Patients receive oral placebo twice daily for 6 weeks.
486342|NCT00702949|B2|Baseline|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
486343|NCT00702949|B1|Baseline|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
486344|NCT00702949|P3|Participant Flow|Placebo|Patients receive oral placebo twice daily for 6 weeks.
486345|NCT00702949|P2|Participant Flow|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
486636|NCT00703157|B1|Baseline|Catheter|Catheter Ablation
486348|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
486349|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
486350|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
486351|NCT00702949|O1|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
486352|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
486353|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
486354|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
486355|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
486356|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
486357|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
486358|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
486359|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
486360|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
486361|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
486362|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
486363|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
486364|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
486365|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
486366|NCT00702949|O1|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
486367|NCT00702949|E3|Reported Event|Placebo|Patients receive oral placebo twice daily for 6 weeks.
486368|NCT00702949|E2|Reported Event|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
486369|NCT00702949|E1|Reported Event|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
486370|NCT00703014|B3|Baseline|Total|Total of all reporting groups
486371|NCT00703014|B2|Baseline|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486372|NCT00703014|B1|Baseline|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486373|NCT00703014|P4|Participant Flow|Fetuses/Infants recFSH 200 IU|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
486374|NCT00703014|P3|Participant Flow|Fetuses/Infants Corifollitropin Alfa 150 µg|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
486375|NCT00703014|P2|Participant Flow|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486376|NCT00703014|P1|Participant Flow|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of human Chorion Gonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick-up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486377|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486637|NCT00703157|P2|Participant Flow|Surgery|Surgical Ablation
486378|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486379|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486380|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486381|NCT00703014|O2|Outcome|Infants recFSH 200 IU|Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
486382|NCT00703014|O1|Outcome|Infants Corifollitropin Alfa 150 µg|Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
486383|NCT00703014|O2|Outcome|Infants recFSH 200 IU|Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
486384|NCT00703014|O1|Outcome|Infants Corifollitropin Alfa 150 µg|Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
486401|NCT00703053|B2|Baseline|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486620|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486385|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486386|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486387|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486388|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486389|NCT00703014|E4|Reported Event|Fetuses/Infants recFSH 200 IU|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
486390|NCT00703014|E3|Reported Event|Fetuses/Infants Corifollitropin Alfa 150 µg|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
486638|NCT00703157|P1|Participant Flow|Catheter|Catheter Ablation
486391|NCT00703014|E2|Reported Event|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486392|NCT00703014|E1|Reported Event|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
486393|NCT00703053|B10|Baseline|Total|Total of all reporting groups
486394|NCT00703053|B9|Baseline|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486395|NCT00703053|B8|Baseline|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486396|NCT00703053|B7|Baseline|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486397|NCT00703053|B6|Baseline|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486398|NCT00703053|B5|Baseline|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486399|NCT00703053|B4|Baseline|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486400|NCT00703053|B3|Baseline|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486402|NCT00703053|B1|Baseline|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486403|NCT00703053|P9|Participant Flow|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486404|NCT00703053|P8|Participant Flow|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486405|NCT00703053|P7|Participant Flow|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486406|NCT00703053|P6|Participant Flow|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486407|NCT00703053|P5|Participant Flow|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486408|NCT00703053|P4|Participant Flow|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486409|NCT00703053|P3|Participant Flow|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486410|NCT00703053|P2|Participant Flow|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486411|NCT00703053|P1|Participant Flow|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486412|NCT00703053|O3|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486413|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486639|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
486640|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
486641|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
486414|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486415|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486416|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486417|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486418|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486419|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486420|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486421|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486422|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486423|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486424|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486425|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486426|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486427|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486748|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486428|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486429|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486430|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486431|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486432|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486433|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486434|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486435|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486436|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486437|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486438|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486642|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
486643|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
486439|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486440|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486441|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486442|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486443|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486444|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486445|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486446|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486447|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486448|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486449|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486450|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486451|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486452|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486453|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486454|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486455|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486456|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486457|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486458|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486459|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486460|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486461|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486462|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486463|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486464|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486465|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486466|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486467|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486468|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486469|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486470|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486471|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486472|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486473|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486474|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486475|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486476|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486477|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486478|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486479|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486480|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486481|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486482|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486483|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486484|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486485|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486486|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486487|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486488|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486489|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486490|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486644|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
486645|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
486646|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
486491|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486492|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486493|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486494|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486495|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486496|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486497|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486498|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486499|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486500|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486501|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486502|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486503|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486504|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486617|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486505|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486506|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486507|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486508|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486509|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486510|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486511|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486512|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486513|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486514|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486515|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486647|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
486516|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486517|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486518|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486519|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486520|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486521|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486522|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486523|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486524|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486525|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486526|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486527|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486528|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486529|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486530|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486531|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486532|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486533|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486534|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486535|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486536|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486537|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486538|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486539|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486540|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486648|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
486649|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
486541|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486542|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486543|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486544|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486545|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486546|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486547|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486548|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486549|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486550|NCT00703053|O8|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486551|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486552|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486553|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486554|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486555|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486618|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486556|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486557|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486558|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486559|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486560|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486561|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486562|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486563|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486564|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486565|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486566|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486567|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486568|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486569|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486570|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486571|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486572|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486573|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486574|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486575|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486576|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486577|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486578|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486579|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486580|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486581|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486582|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486583|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486584|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486585|NCT00703053|E9|Reported Event|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486586|NCT00703053|E8|Reported Event|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486587|NCT00703053|E7|Reported Event|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486588|NCT00703053|E6|Reported Event|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486589|NCT00703053|E5|Reported Event|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
486590|NCT00703053|E4|Reported Event|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486591|NCT00703053|E3|Reported Event|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
486592|NCT00703053|E2|Reported Event|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486593|NCT00703053|E1|Reported Event|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
486594|NCT00703092|B1|Baseline|Fiber-Stat|"2 tablespoons daily
Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
486595|NCT00703092|P1|Participant Flow|Fiber-Stat|"2 tablespoons daily
Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
486596|NCT00703092|O1|Outcome|Fiber-Stat|"2 tablespoons daily
Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
486597|NCT00703092|E1|Reported Event|Fiber-Stat|"2 tablespoons daily
Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
486598|NCT00703118|B4|Baseline|Total|Total of all reporting groups
486599|NCT00703118|B3|Baseline|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486600|NCT00703118|B2|Baseline|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486601|NCT00703118|B1|Baseline|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486602|NCT00703118|P3|Participant Flow|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486603|NCT00703118|P2|Participant Flow|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486604|NCT00703118|P1|Participant Flow|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486605|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486606|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486607|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486608|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486609|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486610|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486611|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486612|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486613|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486614|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486615|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486616|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
488139|NCT00708942|B3|Baseline|Arm 3: No Intervention|
486621|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486622|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486623|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486624|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486625|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486626|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486627|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
486628|NCT00703118|E6|Reported Event|Pbo/PR48 - OVERALL TREATMENT|48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the overall treatment phase
486629|NCT00703118|E5|Reported Event|T12(DS)/PR48 - OVERALL TREATMENT|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
486630|NCT00703118|E4|Reported Event|T12/PR48 - OVERALL TREATMENT|12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
486631|NCT00703118|E3|Reported Event|Pbo/PR48 - TVR/PBO TREATMENT|48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
486632|NCT00703118|E2|Reported Event|T12(DS)/PR48 - TVR/PBO TREATMENT|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
486633|NCT00703118|E1|Reported Event|T12/PR48 - TVR/PBO TREATMENT|12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
486634|NCT00703157|B3|Baseline|Total|Total of all reporting groups
486635|NCT00703157|B2|Baseline|Surgery|Surgical Ablation
486656|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
486657|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
486658|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
486659|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
486660|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
486661|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
486662|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
486663|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
486664|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
486665|NCT00703157|E3|Reported Event|All Randomized Subjects|All Randomized Subjects, regardless of randomization group
486666|NCT00703157|E2|Reported Event|Surgery|Surgical Ablation
486667|NCT00703157|E1|Reported Event|Catheter|Catheter Ablation
486668|NCT00703261|B3|Baseline|Total|Total of all reporting groups
486669|NCT00703261|B2|Baseline|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
486670|NCT00703261|B1|Baseline|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
486671|NCT00703261|P2|Participant Flow|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
486672|NCT00703261|P1|Participant Flow|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
486673|NCT00703261|O1|Outcome|Statin-Naive Participants|Participants self-administered one 10 mg or 80 mg atorvastatin tablet and one matching 80 mg or 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
486674|NCT00703261|O2|Outcome|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one matching 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
486675|NCT00703261|O1|Outcome|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one matching 80 mg atorvastatin placebo tablet orally once daily for 12 weeks.
486676|NCT00703261|E2|Reported Event|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
486749|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486677|NCT00703261|E1|Reported Event|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
486678|NCT00703326|B3|Baseline|Total|Total of all reporting groups
486679|NCT00703326|B2|Baseline|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486680|NCT00703326|B1|Baseline|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486681|NCT00703326|P2|Participant Flow|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486682|NCT00703326|P1|Participant Flow|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486683|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day
1 of each 21-day cycle."
486684|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486685|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486686|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486687|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486688|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486689|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486719|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486720|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486690|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486691|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486692|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486693|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486694|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486695|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486696|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486697|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486698|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486750|NCT00703391|E2|Reported Event|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486699|NCT00703326|E2|Reported Event|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m2) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486700|NCT00703326|E1|Reported Event|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m2) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
486701|NCT00703339|B1|Baseline|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.
Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
486702|NCT00703339|P1|Participant Flow|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.
Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
486703|NCT00703339|O1|Outcome|18mcg Inhaled Treprostinil Cohort|Number of participates on a dose of three 6mcg breaths (18mcg total)with Adverse Events
486704|NCT00703339|E1|Reported Event|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.
Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
486705|NCT00703391|B3|Baseline|Total|Total of all reporting groups
486706|NCT00703391|B2|Baseline|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486707|NCT00703391|B1|Baseline|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486708|NCT00703391|P2|Participant Flow|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486709|NCT00703391|P1|Participant Flow|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486710|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486711|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486712|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486713|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486714|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486715|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486716|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486717|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486718|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486721|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486722|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486723|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486724|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486725|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486726|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486727|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486728|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486729|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486730|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486731|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486732|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486733|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486734|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486735|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486736|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486737|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486738|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486739|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486740|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486741|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486742|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486743|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486744|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486745|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486746|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
486747|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
486752|NCT00703508|B1|Baseline|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration
Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
486753|NCT00703508|P1|Participant Flow|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration
Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
486754|NCT00703508|O3|Outcome|C/C Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
486755|NCT00703508|O2|Outcome|C/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
486756|NCT00703508|O1|Outcome|G/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
486757|NCT00703508|O3|Outcome|C/C Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
486758|NCT00703508|O2|Outcome|C/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
486759|NCT00703508|O1|Outcome|G/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
486760|NCT00703508|O3|Outcome|C/C Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
486761|NCT00703508|O2|Outcome|C/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
486762|NCT00703508|O1|Outcome|G/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
486763|NCT00703508|E1|Reported Event|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration
Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
486764|NCT00703534|B3|Baseline|Total|Total of all reporting groups
486765|NCT00703534|B2|Baseline|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
486766|NCT00703534|B1|Baseline|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
486767|NCT00703534|P2|Participant Flow|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
486768|NCT00703534|P1|Participant Flow|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
486769|NCT00703534|O2|Outcome|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
486770|NCT00703534|O1|Outcome|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
486771|NCT00703534|E2|Reported Event|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
486772|NCT00703534|E1|Reported Event|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
486773|NCT00703677|B1|Baseline|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486774|NCT00703677|P1|Participant Flow|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486775|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486776|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486777|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486823|NCT00703781|B3|Baseline|Total|Total of all reporting groups
486824|NCT00703781|B2|Baseline|Placebo|Placebo, Dosed 1 Drop Daily
486778|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486779|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486780|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486781|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486782|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486783|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486784|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486785|NCT00703677|E1|Reported Event|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
486786|NCT00703729|B3|Baseline|Total|Total of all reporting groups
486787|NCT00703729|B2|Baseline|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486841|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486788|NCT00703729|B1|Baseline|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486789|NCT00703729|P2|Participant Flow|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486790|NCT00703729|P1|Participant Flow|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486791|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486792|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486825|NCT00703781|B1|Baseline|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
486826|NCT00703781|P2|Participant Flow|Placebo|Placebo, Dosed 1 Drop Daily
486827|NCT00703781|P1|Participant Flow|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
486828|NCT00703781|O2|Outcome|Placebo|Placebo, Dosed 1 Drop Daily
486829|NCT00703781|O1|Outcome|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
486793|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486794|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486795|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486796|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486797|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486798|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486799|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486800|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486801|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486802|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486803|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486804|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486805|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486806|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486807|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486808|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486809|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486810|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486811|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486812|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486813|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486814|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486815|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486816|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486817|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486818|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486819|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486820|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486821|NCT00703729|E2|Reported Event|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486822|NCT00703729|E1|Reported Event|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
486831|NCT00703781|O1|Outcome|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
486832|NCT00703781|E2|Reported Event|Placebo|Placebo, Dosed 1 Drop Daily
486833|NCT00703781|E1|Reported Event|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
486834|NCT00703846|B1|Baseline|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486835|NCT00703846|P1|Participant Flow|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. The maximum treatment period was 12 months.
486836|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486837|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486838|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486839|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486840|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486942|NCT00704132|B3|Baseline|Total|Total of all reporting groups
487715|NCT00705367|B1|Baseline|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
486842|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486843|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486844|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486845|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486846|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486847|NCT00703846|E1|Reported Event|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
486848|NCT00703885|B1|Baseline|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|"Alprazolam Low Dose Alprazolam High Dose Placebo
Please note that this is a cross-over design with all subjects receiving all three treatments"
486849|NCT00703885|P1|Participant Flow|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|"Alprazolam Low Dose Alprazolam High Dose Placebo
Sequence of administration not available for subjects"
486850|NCT00703885|O1|Outcome|Imaging Data for Repeated Measures|"Crossover design. Each subject receives, in randomized order and on different days:
Low dose alprazolam High dose alprazolam Placebo"
486851|NCT00703885|O1|Outcome|BOLD fMRI|Cross-over design. Each subject receives, on alternate days and in randomized fashion, either low dose, high dose, or placebo
486852|NCT00703885|E1|Reported Event|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|Alprazolam Low Dose Alprazolam High Dose Placebo
486853|NCT00703911|B1|Baseline|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486854|NCT00703911|P1|Participant Flow|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486855|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486856|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
487212|NCT00705003|P2|Participant Flow|BCI-024 (Buspirone)|1 over-encapsulated tablet of buspirone 15 mg QD
486857|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486858|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486859|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486860|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486861|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486862|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486863|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486864|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486865|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486866|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486867|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486868|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486869|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486870|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486871|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486872|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486873|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486874|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486875|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486876|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486877|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486878|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486879|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486880|NCT00703911|E1|Reported Event|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
486882|NCT00703924|B2|Baseline|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.
Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
486883|NCT00703924|B1|Baseline|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin
WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
486884|NCT00703924|P2|Participant Flow|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.
Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
486885|NCT00703924|P1|Participant Flow|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin
WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
486886|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.
Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
486887|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin
WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
486888|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.
Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
486889|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin
WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
486890|NCT00703924|O4|Outcome|Day 180 (+7 Days)|100% Re-epithelialization by day 180 (+7 days)
486891|NCT00703924|O3|Outcome|Day 100|100% Re-epithelialization by day 100
486892|NCT00703924|O2|Outcome|Day 50|100% Re-epithelialization by day 50
486893|NCT00703924|O1|Outcome|Day 20|100% Re-epithelialization by day 20
486894|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.
Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
486895|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin
WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
486943|NCT00704132|B2|Baseline|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
486896|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.
Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
486897|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin
WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
486898|NCT00703924|E2|Reported Event|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.
Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
486899|NCT00703924|E1|Reported Event|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin
WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
486900|NCT00703937|B3|Baseline|Total|Total of all reporting groups
486901|NCT00703937|B2|Baseline|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
486902|NCT00703937|B1|Baseline|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
486903|NCT00703937|P2|Participant Flow|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
486904|NCT00703937|P1|Participant Flow|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
486905|NCT00703937|O2|Outcome|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
486906|NCT00703937|O1|Outcome|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
486907|NCT00703937|E2|Reported Event|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
486908|NCT00703937|E1|Reported Event|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
486909|NCT00703963|B3|Baseline|Total|Total of all reporting groups
486910|NCT00703963|B2|Baseline|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
486911|NCT00703963|B1|Baseline|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
486912|NCT00703963|P2|Participant Flow|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
487120|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
486913|NCT00703963|P1|Participant Flow|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
486914|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
486915|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
486916|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
486917|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
486918|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
486919|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
486920|NCT00703963|E2|Reported Event|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
486944|NCT00704132|B1|Baseline|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
486921|NCT00703963|E1|Reported Event|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
486922|NCT00703976|B3|Baseline|Total|Total of all reporting groups
486923|NCT00703976|B2|Baseline|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab
Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.
Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.
Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks
Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
486924|NCT00703976|B1|Baseline|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy
Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.
Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.
Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
486925|NCT00703976|P2|Participant Flow|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab
Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.
Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.
Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks
Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
486926|NCT00703976|P1|Participant Flow|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy
Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.
Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.
Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
486927|NCT00703976|O3|Outcome|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab
Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.
Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.
Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks
Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
486973|NCT00704184|B3|Baseline|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
492765|NCT00716742|P1|Participant Flow|Lumigan®|bimatoprost 0.03%
486928|NCT00703976|O2|Outcome|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy
Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.
Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.
Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
486929|NCT00703976|O1|Outcome|All Participants (Overall Study)|
486930|NCT00703976|O2|Outcome|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab
Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.
Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.
Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks
Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
486931|NCT00703976|O1|Outcome|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy
Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.
Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.
Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
486932|NCT00703976|E1|Reported Event|All Participants (Overall Study)|
486933|NCT00704028|B3|Baseline|Total|Total of all reporting groups
486934|NCT00704028|B2|Baseline|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
486935|NCT00704028|B1|Baseline|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
486936|NCT00704028|P2|Participant Flow|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
486937|NCT00704028|P1|Participant Flow|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
486938|NCT00704028|O2|Outcome|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
486939|NCT00704028|O1|Outcome|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
486940|NCT00704028|E2|Reported Event|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
486941|NCT00704028|E1|Reported Event|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
486945|NCT00704132|P2|Participant Flow|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
486946|NCT00704132|P1|Participant Flow|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
486947|NCT00704132|O2|Outcome|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
486948|NCT00704132|O1|Outcome|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
486949|NCT00704132|E2|Reported Event|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
486950|NCT00704132|E1|Reported Event|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
486951|NCT00704171|B3|Baseline|Total|Total of all reporting groups
486952|NCT00704171|B2|Baseline|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
486953|NCT00704171|B1|Baseline|PleuraSeal|PleuraSeal Lung Sealant System
486954|NCT00704171|P2|Participant Flow|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
486955|NCT00704171|P1|Participant Flow|PleuraSeal|PleuraSeal Lung Sealant System
486956|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
486957|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
486958|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
486959|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
486960|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
486961|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
486962|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
486963|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
486964|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
486965|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
486966|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
486967|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
486968|NCT00704171|E2|Reported Event|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
486969|NCT00704171|E1|Reported Event|PleuraSeal|PleuraSeal Lung Sealant System
486970|NCT00704184|B6|Baseline|Total|Total of all reporting groups
486971|NCT00704184|B5|Baseline|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486972|NCT00704184|B4|Baseline|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487176|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
486974|NCT00704184|B2|Baseline|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486975|NCT00704184|B1|Baseline|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486976|NCT00704184|P5|Participant Flow|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486977|NCT00704184|P4|Participant Flow|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486978|NCT00704184|P3|Participant Flow|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486979|NCT00704184|P2|Participant Flow|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486980|NCT00704184|P1|Participant Flow|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486981|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486982|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486983|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486984|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486985|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486986|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486987|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486988|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486989|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486990|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486991|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486992|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486993|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486994|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486995|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486996|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486997|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486998|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
486999|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487000|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487001|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487002|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487003|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487051|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
487004|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487005|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487006|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487007|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487008|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487009|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487010|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487011|NCT00704184|E5|Reported Event|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487012|NCT00704184|E4|Reported Event|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487013|NCT00704184|E3|Reported Event|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487014|NCT00704184|E2|Reported Event|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487015|NCT00704184|E1|Reported Event|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
487016|NCT00704340|B3|Baseline|Total|Total of all reporting groups
487017|NCT00704340|B2|Baseline|Control|Standard of Care (control)
487018|NCT00704340|B1|Baseline|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
487019|NCT00704340|P2|Participant Flow|Control|Standard of Care (control)
487020|NCT00704340|P1|Participant Flow|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
487021|NCT00704340|O2|Outcome|Control|Standard of Care (control)
487022|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
487030|NCT00704353|B2|Baseline|Standard Medical Care|Subjects received standard medical care (as determined by the Investigator) for treatment of IDA.
487031|NCT00704353|B1|Baseline|Ferric Carboxymaltose (FCM)|Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
487032|NCT00704353|P2|Participant Flow|Standard Medical Care|Subjects received standard medical care (as determined by the Investigator) for treatment of IDA.
487033|NCT00704353|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
487034|NCT00704353|O2|Outcome|Standard Medical Care|Received standard medical care (as determined by the Investigator) of IDA.
487035|NCT00704353|O1|Outcome|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
487036|NCT00704353|E2|Reported Event|Standard Medical Care|Received standard medical care (as determined by the Investigator) of IDA.
487037|NCT00704353|E1|Reported Event|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
487038|NCT00704379|B3|Baseline|Total|Total of all reporting groups
487039|NCT00704379|B2|Baseline|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
487040|NCT00704379|B1|Baseline|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
487041|NCT00704379|P2|Participant Flow|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
487042|NCT00704379|P1|Participant Flow|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
487043|NCT00704379|O2|Outcome|Patients Who Did Not Developped a Mood or Anxiety Disorder|
487044|NCT00704379|O1|Outcome|Patients Who Developped a Mood or Anxiety Disorder|
487045|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
487046|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
487047|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
487048|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
487049|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
487050|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
487211|NCT00705003|P3|Participant Flow|Placebo|Matching placebo QD
487052|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
487053|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
487054|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
487055|NCT00704379|E2|Reported Event|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
487056|NCT00704379|E1|Reported Event|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
487057|NCT00704405|B6|Baseline|Total|Total of all reporting groups
487058|NCT00704405|B5|Baseline|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487059|NCT00704405|B4|Baseline|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
487060|NCT00704405|B3|Baseline|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
487061|NCT00704405|B2|Baseline|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
487062|NCT00704405|B1|Baseline|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
487063|NCT00704405|P5|Participant Flow|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487064|NCT00704405|P4|Participant Flow|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
487065|NCT00704405|P3|Participant Flow|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
487066|NCT00704405|P2|Participant Flow|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
487067|NCT00704405|P1|Participant Flow|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
487068|NCT00704405|O2|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487069|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
487070|NCT00704405|O3|Outcome|PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487071|NCT00704405|O2|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487072|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
487073|NCT00704405|O2|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487074|NCT00704405|O1|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487075|NCT00704405|O5|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487076|NCT00704405|O4|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487077|NCT00704405|O3|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487078|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
487079|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
487080|NCT00704405|O5|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487081|NCT00704405|O4|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487082|NCT00704405|O3|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
488033|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
487083|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
487084|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
487085|NCT00704405|O4|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487086|NCT00704405|O3|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487087|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
487088|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
487089|NCT00704405|E5|Reported Event|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
487090|NCT00704405|E4|Reported Event|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
487091|NCT00704405|E3|Reported Event|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
487092|NCT00704405|E2|Reported Event|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
487093|NCT00704405|E1|Reported Event|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
487094|NCT00704418|B3|Baseline|Total|Total of all reporting groups
487095|NCT00704418|B2|Baseline|Placebo|Placebo, dosed 1 drop daily
487096|NCT00704418|B1|Baseline|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
487097|NCT00704418|P2|Participant Flow|Placebo|Placebo, dosed 1 drop daily
487098|NCT00704418|P1|Participant Flow|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
487099|NCT00704418|O2|Outcome|Placebo|Placebo, dosed 1 drop daily
487106|NCT00704522|B2|Baseline|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other
medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
487107|NCT00704522|B1|Baseline|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
487108|NCT00704522|P2|Participant Flow|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other
medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
487109|NCT00704522|P1|Participant Flow|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
487110|NCT00704522|O2|Outcome|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other
medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
487111|NCT00704522|O1|Outcome|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
487112|NCT00704522|O2|Outcome|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other
medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
487113|NCT00704522|O1|Outcome|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
487114|NCT00704522|E1|Reported Event|PegIntron Pen/Rebetol|
487115|NCT00704535|B1|Baseline|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
487116|NCT00704535|P1|Participant Flow|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
487117|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
487118|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
487119|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
487121|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
487122|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
487123|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
487124|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
487125|NCT00704535|E1|Reported Event|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
487126|NCT00704717|B1|Baseline|All Treated Patients|All patients participating in the study.
487127|NCT00704717|P1|Participant Flow|All Treated Patients|All patients participating in the study.
487128|NCT00704717|O1|Outcome|All Treated Patients|All patients participating in the study.
487129|NCT00704717|E1|Reported Event|All Treated Patients|All patients participating in the study.
487130|NCT00704730|B3|Baseline|Total|Total of all reporting groups
487131|NCT00704730|B2|Baseline|Placebo|oral capsules once daily
487132|NCT00704730|B1|Baseline|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
487133|NCT00704730|P2|Participant Flow|Placebo|oral capsules once daily
487134|NCT00704730|P1|Participant Flow|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
487135|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
487136|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
487137|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
487138|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
487139|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
487140|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
487141|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
487142|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
487143|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
487144|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
487146|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
487147|NCT00704730|E2|Reported Event|Placebo|oral capsules once daily
487148|NCT00704730|E1|Reported Event|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
487149|NCT00704769|B1|Baseline|Desloratadine|
487150|NCT00704769|P1|Participant Flow|Desloratadine|
487151|NCT00704769|O1|Outcome|Desloratadine|
487152|NCT00704769|O1|Outcome|Desloratadine|
487153|NCT00704769|E1|Reported Event|Desloratadine|
487154|NCT00704808|B1|Baseline|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
487155|NCT00704808|P1|Participant Flow|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
487156|NCT00704808|O1|Outcome|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
487157|NCT00704808|E1|Reported Event|Temozolomide|
487158|NCT00704847|B3|Baseline|Total|Total of all reporting groups
487159|NCT00704847|B2|Baseline|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
487160|NCT00704847|B1|Baseline|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
487161|NCT00704847|P2|Participant Flow|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
487162|NCT00704847|P1|Participant Flow|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
487163|NCT00704847|O2|Outcome|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
487164|NCT00704847|O1|Outcome|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
487165|NCT00704847|O2|Outcome|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
487166|NCT00704847|O1|Outcome|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
487167|NCT00704847|E2|Reported Event|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
487168|NCT00704847|E1|Reported Event|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
487169|NCT00704912|B4|Baseline|Total|Total of all reporting groups
487170|NCT00704912|B3|Baseline|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
487171|NCT00704912|B2|Baseline|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
487172|NCT00704912|B1|Baseline|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
487173|NCT00704912|P3|Participant Flow|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
487174|NCT00704912|P2|Participant Flow|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
487175|NCT00704912|P1|Participant Flow|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
487177|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
487178|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
487179|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
487180|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
487181|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
487182|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
487183|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
487184|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
487185|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
487186|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
487187|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
487188|NCT00704912|E3|Reported Event|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
487189|NCT00704912|E2|Reported Event|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
487190|NCT00704912|E1|Reported Event|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
487191|NCT00704938|B3|Baseline|Total|Total of all reporting groups
487192|NCT00704938|B2|Baseline|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
487193|NCT00704938|B1|Baseline|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
487194|NCT00704938|P2|Participant Flow|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
487195|NCT00704938|P1|Participant Flow|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
487196|NCT00704938|O2|Outcome|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
487197|NCT00704938|O1|Outcome|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
487198|NCT00704938|O2|Outcome|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
487199|NCT00704938|O1|Outcome|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
487200|NCT00704938|E2|Reported Event|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
487201|NCT00704938|E1|Reported Event|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
487202|NCT00704964|B1|Baseline|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
487203|NCT00704964|P1|Participant Flow|All Participants|"Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
Completers are considered those with documentation who finished the study on time."
487204|NCT00704964|O1|Outcome|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
487205|NCT00704964|O1|Outcome|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
487206|NCT00704964|E1|Reported Event|All Participants|
487207|NCT00705003|B4|Baseline|Total|Total of all reporting groups
487208|NCT00705003|B3|Baseline|Placebo|Placebo QD
487209|NCT00705003|B2|Baseline|BCI-024|Buspirone 15 mg QD
487210|NCT00705003|B1|Baseline|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
487213|NCT00705003|P1|Participant Flow|BCI-024 and BCI-049 (Buspirone and Melatonin)|1 over-encapsulated tablet of buspirone 15 mg and 1 over-encapsulated tablet of melatonin 3 mg QD
487214|NCT00705003|O3|Outcome|Placebo|Placebo QD
487215|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
487216|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
487217|NCT00705003|O3|Outcome|Placebo|Placebo QD
487218|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
487219|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
487220|NCT00705003|O3|Outcome|Placebo|Placebo QD
487221|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
487222|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
487223|NCT00705003|O3|Outcome|Placebo|Placebo QD
487224|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
487225|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
487226|NCT00705003|O3|Outcome|Placebo|Placebo QD
487227|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
487228|NCT00705003|O1|Outcome|BCI-024+BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
487229|NCT00705003|E3|Reported Event|Placebo|Placebo QD
487230|NCT00705003|E2|Reported Event|BCI-024|Buspirone 15 mg QD
487231|NCT00705003|E1|Reported Event|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
487232|NCT00705016|B4|Baseline|Total|Total of all reporting groups
487233|NCT00705016|B3|Baseline|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487267|NCT00705081|P1|Participant Flow|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
487268|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
488140|NCT00708942|B2|Baseline|Arm 2: Placebo Suppository, Laser Illumination|
487234|NCT00705016|B2|Baseline|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487235|NCT00705016|B1|Baseline|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487236|NCT00705016|P3|Participant Flow|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487237|NCT00705016|P2|Participant Flow|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487238|NCT00705016|P1|Participant Flow|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487239|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487298|NCT00705159|P3|Participant Flow|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
487240|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487241|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487242|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487243|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487391|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
487244|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487245|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487246|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487247|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487248|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487249|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487250|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487251|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487252|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487253|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
488141|NCT00708942|B1|Baseline|Arm 1: HAL Suppository, Laser Illumination|
487254|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487255|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487256|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487257|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487258|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487259|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487260|NCT00705016|E3|Reported Event|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487261|NCT00705016|E2|Reported Event|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487262|NCT00705016|E1|Reported Event|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
487263|NCT00705081|B3|Baseline|Total|Total of all reporting groups
487264|NCT00705081|B2|Baseline|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
487265|NCT00705081|B1|Baseline|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
487266|NCT00705081|P2|Participant Flow|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
487392|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
487269|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
487270|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
487271|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
487272|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
487273|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
487274|NCT00705081|E2|Reported Event|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
487275|NCT00705081|E1|Reported Event|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
487276|NCT00705107|B1|Baseline|All Treated Patients|
487277|NCT00705107|P1|Participant Flow|All Treated Patients|
487278|NCT00705107|O1|Outcome|All Treated Patients|
487279|NCT00705107|O1|Outcome|All Treated Patients|
487280|NCT00705107|E1|Reported Event|All Treated Patients|
487281|NCT00705146|B3|Baseline|Total|Total of all reporting groups
487282|NCT00705146|B2|Baseline|Comfort Cool Then Hybrid Splint|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
487283|NCT00705146|B1|Baseline|Hybrid Then Comfort Cool|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
487284|NCT00705146|P2|Participant Flow|Comfort Cool Splint 4 Weeks, 1 Week Washout, Then Hybrid Splin|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
487285|NCT00705146|P1|Participant Flow|Hybrid Splint 4 Weeks, 1 Week Washout, Then Comfort Cool Splin|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
487286|NCT00705146|O2|Outcome|Comfort Cool Splint|Use of the comfort cool splint for 4 weeks
487287|NCT00705146|O1|Outcome|Hybrid Splint|Use of the hybrid splint for 4 weeks
487288|NCT00705146|O2|Outcome|Comfort Cool Splint|Use of the comfort cool splint for 4 weeks
487289|NCT00705146|O1|Outcome|Hybrid Splint|Use of the hybrid splint for 4 weeks
487290|NCT00705146|E2|Reported Event|Comfort Cool Then Hybrid Splint|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
487291|NCT00705146|E1|Reported Event|Hybrid Then Comfort Cool|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
487292|NCT00705159|B5|Baseline|Total|Total of all reporting groups
487293|NCT00705159|B4|Baseline|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
487294|NCT00705159|B3|Baseline|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
487295|NCT00705159|B2|Baseline|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
487296|NCT00705159|B1|Baseline|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
487297|NCT00705159|P4|Participant Flow|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
487299|NCT00705159|P2|Participant Flow|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
487300|NCT00705159|P1|Participant Flow|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
487301|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
487302|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
487303|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
487304|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
487305|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
487306|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
487307|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
487308|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
487309|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
487310|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
487311|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
487312|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
487313|NCT00705159|E4|Reported Event|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
487314|NCT00705159|E3|Reported Event|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
487315|NCT00705159|E2|Reported Event|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
487316|NCT00705159|E1|Reported Event|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
487461|NCT00693420|O2|Outcome|Vehicle Solution|
487317|NCT00705224|B1|Baseline|Pegylated Interferon and Ribavirin|"Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous
injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the
morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C."
487318|NCT00705224|P1|Participant Flow|Pegylated Interferon and Ribavirin|"Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous
injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the
morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C."
487319|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
487320|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
487321|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
487336|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
487337|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
487338|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
492766|NCT00716742|O3|Outcome|Xalatan®|latanoprost 0.005%
487322|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and a stage of hepatitis C.
487323|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
487324|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
487325|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
487348|NCT00692419|O3|Outcome|Management Group - Change in ED Score|Management group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.
487349|NCT00692419|O2|Outcome|Feedback Group - Change in Pain Score|Feedback group - change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.
487326|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
487327|NCT00705224|O1|Outcome|Pegylated Interferon and Ribavirin|Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
487328|NCT00705224|E1|Reported Event|Pegylated Interferon and Ribavirin|"Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous
injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the
morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C."
487329|NCT00692406|B1|Baseline|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
487330|NCT00692406|P1|Participant Flow|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
487331|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
487332|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
487333|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
487334|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
487335|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
492767|NCT00716742|O2|Outcome|Travatan®|travoprost 0.004%
487339|NCT00692406|E1|Reported Event|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
487340|NCT00692419|B3|Baseline|Total|Total of all reporting groups
487341|NCT00692419|B2|Baseline|Feedback Intervention|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider
Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
487342|NCT00692419|B1|Baseline|Symptom Management Intervention|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression
Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
487343|NCT00692419|P2|Participant Flow|Arm 2|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider
Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
487344|NCT00692419|P1|Participant Flow|Arm 1|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression
Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
487345|NCT00692419|O6|Outcome|Feedback Arm Change in Depression Score|Feedback arm change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.
487346|NCT00692419|O5|Outcome|Management Group - Change in Depression Score|Management group - change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.
487347|NCT00692419|O4|Outcome|Feedback Group - Change in ED Score|Feedback group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.
487350|NCT00692419|O1|Outcome|Management Arm Change in Pain Score|Management arm change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.
487351|NCT00692419|E2|Reported Event|Arm 2|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider
Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
487352|NCT00692419|E1|Reported Event|Arm 1|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression
Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
487353|NCT00692692|B1|Baseline|Acellular Dermal Matrix|vs control group with traditional muscle cover of tissue expander only
487354|NCT00692692|P2|Participant Flow|Control 2|"muscle over tissue expanders
DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy
muscle coverage over tissue expander : Tissue expander reconstruction"
487355|NCT00692692|P1|Participant Flow|Experimental 1|"DermaMatrix acellular dermis over tissue expanders
DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy"
487356|NCT00692692|O2|Outcome|Experimental 1|acellular dermal matrix for total coverage of tissue expander after mastectomy for breast reconstruciton.
487357|NCT00692692|O1|Outcome|Control 2|"muscle over tissue expanders
DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy
muscle coverage over tissue expander : Tissue expander reconstruction"
487358|NCT00692692|E2|Reported Event|Control 2|"muscle over tissue expanders
DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy
muscle coverage over tissue expander : Tissue expander reconstruction"
487359|NCT00692692|E1|Reported Event|Experimental 1|"DermaMatrix acellular dermis over tissue expanders
DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy"
487360|NCT00692770|B3|Baseline|Total|Total of all reporting groups
487361|NCT00692770|B2|Baseline|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
487362|NCT00692770|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
487363|NCT00692770|P2|Participant Flow|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
487364|NCT00692770|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
487365|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
487366|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
487367|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
487368|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
487369|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
487370|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
487371|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
487372|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
487373|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
487374|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
487375|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
487376|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
487377|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
487378|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
487379|NCT00692770|E2|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
487380|NCT00692770|E1|Reported Event|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
487381|NCT00692913|B3|Baseline|Total|Total of all reporting groups
487382|NCT00692913|B2|Baseline|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
487383|NCT00692913|B1|Baseline|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
487384|NCT00692913|P2|Participant Flow|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
487385|NCT00692913|P1|Participant Flow|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
487386|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
487387|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
487388|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
487389|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
487390|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
487393|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
487394|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
487395|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
487396|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
487397|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
487398|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
487399|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
487400|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
487401|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
487402|NCT00692913|E2|Reported Event|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
487403|NCT00692913|E1|Reported Event|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
487404|NCT00693017|B3|Baseline|Total|Total of all reporting groups
487405|NCT00693017|B2|Baseline|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)"
487406|NCT00693017|B1|Baseline|Zonisamide|"50-400 mg capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)"
487407|NCT00693017|P2|Participant Flow|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)"
487408|NCT00693017|P1|Participant Flow|Zonisamide|"50-400 mg capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)"
487409|NCT00693017|O2|Outcome|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)"
487433|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
487410|NCT00693017|O1|Outcome|Zonisamide|"50-400 mg capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)"
487411|NCT00693017|O2|Outcome|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)"
487412|NCT00693017|O1|Outcome|Zonisamide|"50-400 mg capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)"
487413|NCT00693017|E2|Reported Event|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)"
487414|NCT00693017|E1|Reported Event|Zonisamide|"50-400 mg capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)"
487415|NCT00693160|B3|Baseline|Total|Total of all reporting groups
487416|NCT00693160|B2|Baseline|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
487417|NCT00693160|B1|Baseline|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
487462|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
487463|NCT00693420|O2|Outcome|Vehicle Solution|
487464|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
487465|NCT00693420|O2|Outcome|Vehicle Solution|
487466|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
487467|NCT00693420|O2|Outcome|Vehicle Solution|
487468|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
487469|NCT00693420|O2|Outcome|Vehicle Solution|
487418|NCT00693160|P2|Participant Flow|Placebo Intrathecal Injection|"In the presence of remifentanil subjects received a single intrathecal injection of placebo (preservative-free normal saline).
The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.
The remifentanil infusion was titrated based on the subjects’ pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes."
487419|NCT00693160|P1|Participant Flow|Intrathecal Ketorolac|"In the presence of a remifentanil infusion subjects received a single intrathecal injection of ketorolac 2 mg.
The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.
The remifentanil infusion was titrated based on the subjects’ pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes."
487420|NCT00693160|O2|Outcome|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
487421|NCT00693160|O1|Outcome|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
487422|NCT00693160|O2|Outcome|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
487423|NCT00693160|O1|Outcome|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
487424|NCT00693160|E2|Reported Event|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
487425|NCT00693160|E1|Reported Event|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
487426|NCT00693225|B3|Baseline|Total|Total of all reporting groups
487427|NCT00693225|B2|Baseline|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
487428|NCT00693225|B1|Baseline|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
487429|NCT00693225|P2|Participant Flow|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
487430|NCT00693225|P1|Participant Flow|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
487431|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
487432|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
487695|NCT00705289|O2|Outcome|Male|
487434|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
487435|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
487436|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
487437|NCT00693225|E2|Reported Event|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
487438|NCT00693225|E1|Reported Event|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
487439|NCT00693238|B3|Baseline|Total|Total of all reporting groups
487440|NCT00693238|B2|Baseline|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
487441|NCT00693238|B1|Baseline|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
487442|NCT00693238|P2|Participant Flow|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
487443|NCT00693238|P1|Participant Flow|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
487444|NCT00693238|O2|Outcome|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
487445|NCT00693238|O1|Outcome|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
487446|NCT00693238|E2|Reported Event|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
487447|NCT00693238|E1|Reported Event|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
487448|NCT00693303|B1|Baseline|My Scrivener Training|Children received My Scrivenor training
487449|NCT00693303|P1|Participant Flow|My Scrivener Training|Children received My Scrivenor training
487450|NCT00693303|O1|Outcome|My Scrivener Training|Children received My Scrivenor training
487451|NCT00693303|E1|Reported Event|My Scrivener Training|Children received My Scrivenor training
487452|NCT00693420|B3|Baseline|Total|Total of all reporting groups
487453|NCT00693420|B2|Baseline|Vehicle Solution|
487454|NCT00693420|B1|Baseline|Bimatoprost 0.03% Solution|
487455|NCT00693420|P2|Participant Flow|Vehicle Solution|
487456|NCT00693420|P1|Participant Flow|Bimatoprost 0.03% Solution|
487457|NCT00693420|O2|Outcome|Vehicle Solution|
487458|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
487459|NCT00693420|O2|Outcome|Vehicle Solution|
487460|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
487480|NCT00693472|B4|Baseline|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
487481|NCT00693472|B3|Baseline|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487482|NCT00693472|B2|Baseline|Part 1: Placebo|Placebo every 12 hours for 13 days
487483|NCT00693472|B1|Baseline|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487484|NCT00693472|P4|Participant Flow|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
487485|NCT00693472|P3|Participant Flow|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487486|NCT00693472|P2|Participant Flow|Part 1: Placebo|Placebo every 12 hours for 13 days
487487|NCT00693472|P1|Participant Flow|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487488|NCT00693472|O2|Outcome|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
487489|NCT00693472|O1|Outcome|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487490|NCT00693472|O2|Outcome|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
487491|NCT00693472|O1|Outcome|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487492|NCT00693472|O2|Outcome|Part 1: Placebo|Placebo every 12 hours for 13 days
487493|NCT00693472|O1|Outcome|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487494|NCT00693472|O2|Outcome|Part 1: Placebo|Placebo every 12 hours for 13 days
487495|NCT00693472|O1|Outcome|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487496|NCT00693472|O2|Outcome|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
487497|NCT00693472|O1|Outcome|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487498|NCT00693472|O2|Outcome|Part 1: Placebo|Placebo every 12 hours for 13 days
487499|NCT00693472|O1|Outcome|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487500|NCT00693472|E4|Reported Event|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487501|NCT00693472|E3|Reported Event|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
487502|NCT00693472|E2|Reported Event|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
487503|NCT00693472|E1|Reported Event|Part 1: Placebo|Placebo every 12 hours for 13 days
487504|NCT00693485|B4|Baseline|Total|Total of all reporting groups
487505|NCT00693485|B3|Baseline|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487506|NCT00693485|B2|Baseline|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487507|NCT00693485|B1|Baseline|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487508|NCT00693485|P3|Participant Flow|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487509|NCT00693485|P2|Participant Flow|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487510|NCT00693485|P1|Participant Flow|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
492768|NCT00716742|O1|Outcome|Lumigan®|bimatoprost 0.03%
487511|NCT00693485|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487512|NCT00693485|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487513|NCT00693485|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487514|NCT00693485|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487515|NCT00693485|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487516|NCT00693485|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487517|NCT00693485|E3|Reported Event|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487518|NCT00693485|E2|Reported Event|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487519|NCT00693485|E1|Reported Event|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
487520|NCT00693498|B3|Baseline|Total|Total of all reporting groups
487521|NCT00693498|B2|Baseline|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
487522|NCT00693498|B1|Baseline|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
487523|NCT00693498|P2|Participant Flow|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
487524|NCT00693498|P1|Participant Flow|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
487525|NCT00693498|O2|Outcome|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
487526|NCT00693498|O1|Outcome|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
487527|NCT00693498|E2|Reported Event|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
487528|NCT00693498|E1|Reported Event|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
487529|NCT00693628|B3|Baseline|Total|Total of all reporting groups
487530|NCT00693628|B2|Baseline|No Shrinker|Patients will receive no shrinker
487765|NCT00705406|E1|Reported Event|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487531|NCT00693628|B1|Baseline|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.
compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
487532|NCT00693628|P2|Participant Flow|No Shrinker|Patients will receive no shrinker
487533|NCT00693628|P1|Participant Flow|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.
compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
487534|NCT00693628|O2|Outcome|No Shrinker|Patients will receive no shrinker
487535|NCT00693628|O1|Outcome|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.
compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
487536|NCT00693628|E2|Reported Event|No Shrinker|Patients will receive no shrinker
487537|NCT00693628|E1|Reported Event|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.
compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
487538|NCT00693654|B3|Baseline|Total|Total of all reporting groups
487539|NCT00693654|B2|Baseline|Placebo|Placebo lotion (Cetaphil)
487540|NCT00693654|B1|Baseline|Active|Active Medicated Lotion (Sarna)
487541|NCT00693654|P2|Participant Flow|Placebo Cetaphil Lotion|Placebo lotion (Cetaphil) applied twice daily to areas of pruritus
487542|NCT00693654|P1|Participant Flow|Pramoxine Lotion|Active Medicated Pramoxine Lotion (Sarna) applied topically twice daily to areas of pruritus
487543|NCT00693654|O2|Outcome|Placebo|Placebo lotion (Cetaphil)
487544|NCT00693654|O1|Outcome|Active|Active Medicated Lotion (Sarna)
487545|NCT00693654|O2|Outcome|Placebo|Placebo lotion (Cetaphil)
487546|NCT00693654|O1|Outcome|Active|Active Medicated Pramoxine Lotion (Sarna)
487547|NCT00693654|E2|Reported Event|Placebo|Placebo lotion (Cetaphil)
487548|NCT00693654|E1|Reported Event|Active|Active Medicated Lotion (Sarna)
487549|NCT00693693|B4|Baseline|Total|Total of all reporting groups
487550|NCT00693693|B3|Baseline|Lipocream|topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily
487551|NCT00693693|B2|Baseline|Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily
487552|NCT00693693|B1|Baseline|Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily
487553|NCT00693693|P3|Participant Flow|Cream|topical hydrocortisone 17-butyrate 0.1% preparation cream
487554|NCT00693693|P2|Participant Flow|Lipocream|topical hydrocortisone 17-butyrate 0.1% preparation lipocream
487555|NCT00693693|P1|Participant Flow|Ointment|topical hydrocortisone 17-butyrate 0.1% preparation ointment
487556|NCT00693693|O3|Outcome|Lipocream|topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily to all areas of atopic dermatitis
487557|NCT00693693|O2|Outcome|Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily to all areas of atopic dermatitis
487558|NCT00693693|O1|Outcome|Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily to all areas of atopic dermatitis
487559|NCT00693693|E3|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Lipocream|topical hydrocortisone 17-butyrate 0.1% lipocream applied twice daily
492769|NCT00716742|E3|Reported Event|Xalatan®|latanoprost 0.005%
487560|NCT00693693|E2|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily
487561|NCT00693693|E1|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily
487562|NCT00693706|B3|Baseline|Total|Total of all reporting groups
487563|NCT00693706|B2|Baseline|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487564|NCT00693706|B1|Baseline|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487565|NCT00693706|P2|Participant Flow|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487566|NCT00693706|P1|Participant Flow|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487567|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487568|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487569|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487570|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487571|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487572|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487663|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
487664|NCT00699582|O1|Outcome|Placebo|
487573|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487574|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487575|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487576|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487577|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487578|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487579|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487580|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487581|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487582|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487583|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487584|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487585|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487586|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487587|NCT00693706|E2|Reported Event|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487588|NCT00693706|E1|Reported Event|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
487589|NCT00693719|B1|Baseline|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
487590|NCT00693719|P1|Participant Flow|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
487591|NCT00693719|O1|Outcome|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
487592|NCT00693719|O1|Outcome|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
487593|NCT00693719|E1|Reported Event|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
487594|NCT00693784|B1|Baseline|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
487595|NCT00693784|P1|Participant Flow|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
487596|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
487597|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
487598|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
487599|NCT00693784|E1|Reported Event|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
487600|NCT00693992|B3|Baseline|Total|Total of all reporting groups
487601|NCT00693992|B2|Baseline|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies"
487602|NCT00693992|B1|Baseline|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Sunitinib Malate: Given PO"
487603|NCT00693992|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies"
487711|NCT00705341|E2|Reported Event|High Dose for Phase 2|4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
487604|NCT00693992|P1|Participant Flow|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Sunitinib Malate: Given PO"
487605|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies"
487606|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Sunitinib Malate: Given PO"
487607|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies"
487608|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Sunitinib Malate: Given PO"
487609|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies"
487610|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Sunitinib Malate: Given PO"
487611|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies"
487612|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Sunitinib Malate: Given PO"
487613|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies"
487614|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Sunitinib Malate: Given PO"
487615|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies"
487737|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
487616|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Sunitinib Malate: Given PO"
487617|NCT00693992|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies"
487618|NCT00693992|E1|Reported Event|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Sunitinib Malate: Given PO"
487619|NCT00699491|B7|Baseline|Total|Total of all reporting groups
487620|NCT00699491|B6|Baseline|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.
15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487621|NCT00699491|B5|Baseline|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487622|NCT00699491|B4|Baseline|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487623|NCT00699491|B3|Baseline|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487624|NCT00699491|B2|Baseline|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487625|NCT00699491|B1|Baseline|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487626|NCT00699491|P6|Participant Flow|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.
15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487627|NCT00699491|P5|Participant Flow|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487628|NCT00699491|P4|Participant Flow|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487629|NCT00699491|P3|Participant Flow|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487630|NCT00699491|P2|Participant Flow|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487631|NCT00699491|P1|Participant Flow|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487632|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.
15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487633|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.
15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487634|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.
15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487635|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.
15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487636|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.
15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487637|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.
15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487638|NCT00699491|O5|Outcome|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487639|NCT00699491|O4|Outcome|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487738|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
487739|NCT00705367|E2|Reported Event|Placebo|
487640|NCT00699491|O3|Outcome|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487641|NCT00699491|O2|Outcome|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487642|NCT00699491|O1|Outcome|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
487643|NCT00699491|E6|Reported Event|Phase II|laboratory biomarker analysis: Correlative studies
487644|NCT00699491|E5|Reported Event|Dose Level -2B|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
487645|NCT00699491|E4|Reported Event|Dose Level -2A|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
487646|NCT00699491|E3|Reported Event|Dose Level -2|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
487647|NCT00699491|E2|Reported Event|Dose Level -1|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
487648|NCT00699491|E1|Reported Event|Dose Level 1|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
487649|NCT00699582|B4|Baseline|Total|Total of all reporting groups
487650|NCT00699582|B3|Baseline|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
487651|NCT00699582|B2|Baseline|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
487652|NCT00699582|B1|Baseline|Placebo|
487653|NCT00699582|P3|Participant Flow|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
487654|NCT00699582|P2|Participant Flow|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
487655|NCT00699582|P1|Participant Flow|Placebo|
487656|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
487657|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
487658|NCT00699582|O1|Outcome|Placebo|
487659|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
487660|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
487661|NCT00699582|O1|Outcome|Placebo|
487662|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
487665|NCT00699582|E3|Reported Event|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
487666|NCT00699582|E2|Reported Event|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
487667|NCT00699582|E1|Reported Event|Placebo|
487668|NCT00705250|B1|Baseline|All Participants|
487669|NCT00705250|P1|Participant Flow|All Participants|Patients will receive bendamustine 120mg/m2, administered as a 30-minute infusion.
487670|NCT00705250|O1|Outcome|All Participants|
487671|NCT00705250|E1|Reported Event|All Participants|
487672|NCT00705263|B1|Baseline|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
487673|NCT00705263|P1|Participant Flow|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
487674|NCT00705263|O1|Outcome|Patients Treated With PegIntron Pen Plus Rebetol|
487675|NCT00705263|E1|Reported Event|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
487676|NCT00705289|B1|Baseline|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
487677|NCT00705289|P1|Participant Flow|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
487678|NCT00705289|O4|Outcome|Established RA, Failed/Did Not Tolerate Another Anti-TNF|Subjects with established RA having failed or not tolerated another anti-TNF.
487679|NCT00705289|O3|Outcome|Established RA, Not Treated With Anti-TNF|Subjects with established RA not yet treated with an anti-TNF.
487680|NCT00705289|O2|Outcome|Early RA, Not Treated With Anti-TNF|Subjects with early RA not yet treated with an anti-TNF.
487681|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
487682|NCT00705289|O12|Outcome|Sweden|
487683|NCT00705289|O11|Outcome|Portugal|
487684|NCT00705289|O10|Outcome|Poland|
487685|NCT00705289|O9|Outcome|Norway|
487686|NCT00705289|O8|Outcome|Netherlands|
487687|NCT00705289|O7|Outcome|Italy|
487688|NCT00705289|O6|Outcome|Greece|
487689|NCT00705289|O5|Outcome|Germany|
487690|NCT00705289|O4|Outcome|France|
487691|NCT00705289|O3|Outcome|Denmark|
487692|NCT00705289|O2|Outcome|Belgium|
487693|NCT00705289|O1|Outcome|Austria|
487694|NCT00705289|O3|Outcome|Female|
487696|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
487697|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
487698|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
487699|NCT00705289|E1|Reported Event|Infliximab 3 mg/kg|
487700|NCT00705341|B3|Baseline|Total|Total of all reporting groups
487701|NCT00705341|B2|Baseline|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
487702|NCT00705341|B1|Baseline|Nonasthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
487703|NCT00705341|P4|Participant Flow|High Dose, Then Low Dose Fluticasone for Phase 2|People with asthma receive fluticasone at 1000 mcg per day 28 days), then wash-out period (28 days), fluticasone at 250 mcg per day (28 days) in phase 2.
487704|NCT00705341|P3|Participant Flow|Low Dose, Then High Dose Fluticasone for Phase 2|People with asthma receive fluticasone at 250 mcg per day (28 days), then wash-out period (28 days), then fluticasone at 1000 mcg per day (28 days) in phase 2.
487705|NCT00705341|P2|Participant Flow|Non Asthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
487706|NCT00705341|P1|Participant Flow|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
487707|NCT00705341|O2|Outcome|Non Asthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
487708|NCT00705341|O1|Outcome|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
487709|NCT00705341|O2|Outcome|4 Weeks of Low Dose Fluticasone|4 weeks of Fluticasone (Flovent diskus) 250 mcg once daily
487710|NCT00705341|O1|Outcome|4 Weeks of High Dose Fluticasone|4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
487766|NCT00705432|B7|Baseline|Total|Total of all reporting groups
487716|NCT00705367|P2|Participant Flow|Placebo/Abatacept,10 mg/kg|Short-term period: Participants received a single dose of placebo intravenously Long-term period: Placebo arm discontinued. All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
487717|NCT00705367|P1|Participant Flow|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
487718|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
487719|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
487720|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
487721|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
487722|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
487723|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
487724|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
487725|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
487726|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
487727|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
487728|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
487729|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
487730|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
487731|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
487732|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
487733|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
487734|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
487735|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
487736|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
487742|NCT00705406|B2|Baseline|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
487743|NCT00705406|B1|Baseline|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487744|NCT00705406|P2|Participant Flow|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
487745|NCT00705406|P1|Participant Flow|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487746|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
487747|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487748|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
487749|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487750|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
487751|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487752|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
487753|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487754|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
487755|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487756|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
487757|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487758|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection
487759|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487760|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
487761|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487762|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
487763|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
487764|NCT00705406|E2|Reported Event|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
488142|NCT00708942|P5|Participant Flow|Arm 5: Placebo Ointment, no Illumination|
487767|NCT00705432|B6|Baseline|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487768|NCT00705432|B5|Baseline|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487769|NCT00705432|B4|Baseline|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487770|NCT00705432|B3|Baseline|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487771|NCT00705432|B2|Baseline|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487772|NCT00705432|B1|Baseline|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487773|NCT00705432|P6|Participant Flow|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487774|NCT00705432|P5|Participant Flow|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487775|NCT00705432|P4|Participant Flow|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487845|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487776|NCT00705432|P3|Participant Flow|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487777|NCT00705432|P2|Participant Flow|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487778|NCT00705432|P1|Participant Flow|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487779|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487780|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487781|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487782|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487820|NCT00705523|O1|Outcome|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
487821|NCT00705523|E2|Reported Event|Placebo|placebo : BID 12 weeks
487822|NCT00705523|E1|Reported Event|Varenicline|varenicline : 1.0 mg BID for 12 weeks
487783|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487784|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487785|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487786|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487787|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487788|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487789|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487790|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487791|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487792|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487793|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487794|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487795|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487796|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487797|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487823|NCT00705536|B3|Baseline|Total|Total of all reporting groups
487824|NCT00705536|B2|Baseline|Stage 2: Humulin-R Alone or Humulin-R + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R alone or 20 U Humulin-R + 240 U recombinant human hyaluronidase (rHuPH20), followed by crossover treatment after a washout period of at least 6 days.
487825|NCT00705536|B1|Baseline|Stage 1: Humalog Alone or Humalog + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog alone or 20 U Humalog + 300 U recombinant human hyaluronidase (rHuPH20), followed by crossover treatment after a washout period of at least 6 days.
487798|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487799|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487800|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487801|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487802|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487803|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487804|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487805|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487806|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487807|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487808|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487809|NCT00705432|E3|Reported Event|BOCEPRIVIR + PEG + RBV - 44 WEEKS|Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487810|NCT00705432|E2|Reported Event|BOCEPREVIR + PEG + RBV - 24 WEEKS|"Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
487811|NCT00705432|E1|Reported Event|PEG + RBV|Cohort I (White participants) and Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487812|NCT00705523|B3|Baseline|Total|Total of all reporting groups
487813|NCT00705523|B2|Baseline|Placebo|placebo : BID 12 weeks
487814|NCT00705523|B1|Baseline|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
487815|NCT00705523|P2|Participant Flow|Placebo|placebo : BID 12 weeks
487816|NCT00705523|P1|Participant Flow|Varenicline|varenicline : 1.0 mg BID for 12 weeks
487817|NCT00705523|O2|Outcome|Placebo|placebo : BID 12 weeks
487818|NCT00705523|O1|Outcome|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
487819|NCT00705523|O2|Outcome|Placebo|placebo : BID 12 weeks
487826|NCT00705536|P4|Participant Flow|Stage 2: Humulin-R + rHuPH20 First, Then Humulin-R|Stage 2 of the study. A single subcutaneous (SC) injection of 20 units (U) Humulin-R + 240 U recombinant human hyaluronidase PH20 (rHuPH20) on Day 1 of Stage 2, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humulin-R alone.
487827|NCT00705536|P3|Participant Flow|Stage 2: Humulin-R First, Then Humulin-R + rHuPH20|Stage 2 of the study: A single subcutaneous (SC) injection of 20 units (U) Humulin-R alone on Day 1 of Stage 2, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humulin-R + 240 U recombinant human hyaluronidase PH20 (rHuPH20).
487828|NCT00705536|P2|Participant Flow|Stage 1: Humalog + rHuPH20 First, Then Humalog|Stage 1 of the study: A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U recombinant human hyaluronidase PH20 (rHuPH20) on Day 1 of Stage 1, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humalog alone.
487829|NCT00705536|P1|Participant Flow|Stage 1: Humalog First, Then Humalog + rHuPH20|Stage 1 of the study: A single subcutaneous (SC) injection of 20 units (U) Humalog alone on Day 1 of Stage 1, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humalog + 300 U recombinant human hyaluronidase PH20 (rHuPH20).
487830|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487831|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin: A single subcutaneous (SC) injection of 20 units (U)
487832|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487833|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487834|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487835|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
487836|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487837|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487838|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487839|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
487840|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487841|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487842|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487843|NCT00705536|O3|Outcome|Stage 2: Humulin Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
487844|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487846|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487847|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
487848|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487849|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487850|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487851|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
487852|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487853|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487854|NCT00705536|O2|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) of Humulin-R and 240 U of rHuPH20
487855|NCT00705536|O1|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) of Humalog and 300 U of rHuPH20
487856|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487857|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
487858|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487859|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487860|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487861|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
487862|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487863|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487954|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487864|NCT00705536|O3|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487865|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487866|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487867|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487868|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
487869|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) : A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U rHuPH20
487870|NCT00705536|O1|Outcome|Stage 1. Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487871|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487872|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
487873|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487874|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487875|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487876|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
487877|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487878|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487879|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
487880|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
487881|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
487882|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
487883|NCT00705536|E4|Reported Event|Stage 2: Humulin-R + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R + 240 U recombinant human hyaluronidase (rHuPH20) during Stage 2 of the study
487884|NCT00705536|E3|Reported Event|Stage 2: Humulin-R Alone|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R alone during Stage 2 of the study
487885|NCT00705536|E2|Reported Event|Stage 1: Humalog + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U recombinant human hyaluronidase (rHuPH20) during Stage 1 of the study
488030|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
487886|NCT00705536|E1|Reported Event|Stage 1: Humalog Alone|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog alone during Stage 1 of the study
487887|NCT00705575|B3|Baseline|Total|Total of all reporting groups
487888|NCT00705575|B2|Baseline|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
487889|NCT00705575|B1|Baseline|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
487890|NCT00705575|P2|Participant Flow|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
487891|NCT00705575|P1|Participant Flow|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
487892|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
487893|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
487894|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
487895|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
487896|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
487897|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
487898|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
487899|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
487900|NCT00705575|E2|Reported Event|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
487901|NCT00705575|E1|Reported Event|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
487902|NCT00708305|B1|Baseline|Overall Study|All randomized participants
487903|NCT00708305|P4|Participant Flow|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487904|NCT00708305|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487905|NCT00708305|P2|Participant Flow|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487906|NCT00708305|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)|Participants brushed their natural teeth for one timed minute with 1.6 grams (g) of with NaF and 0.4% carbopol toothpaste (1450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487907|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487908|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487909|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487910|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds
487911|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487912|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
492770|NCT00716742|E2|Reported Event|Travatan®|travoprost 0.004%
487913|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487914|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487915|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487916|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487917|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487918|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487919|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487920|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487921|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487922|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
488143|NCT00708942|P4|Participant Flow|Arm 4: HAL Ointment, LED Diode Illumination|
487923|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487924|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487925|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487926|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487927|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487928|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487929|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487930|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487931|NCT00708305|O2|Outcome|NaF Toothpaste (1400 Ppm F)|Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487932|NCT00708305|O1|Outcome|NaF Toothpaste(1450 Ppm F)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487933|NCT00708305|E4|Reported Event|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
488031|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
492771|NCT00716742|E1|Reported Event|Lumigan®|bimatoprost 0.03%
487934|NCT00708305|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487935|NCT00708305|E2|Reported Event|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487936|NCT00708305|E1|Reported Event|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
487937|NCT00708422|B3|Baseline|Total|Total of all reporting groups
487938|NCT00708422|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
487939|NCT00708422|B1|Baseline|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
487940|NCT00708422|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
487941|NCT00708422|P1|Participant Flow|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
487942|NCT00708422|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
487943|NCT00708422|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
487944|NCT00708422|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
487945|NCT00708422|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
487946|NCT00708422|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
487947|NCT00708422|E1|Reported Event|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
487948|NCT00708435|B3|Baseline|Total|Total of all reporting groups
487949|NCT00708435|B2|Baseline|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
487950|NCT00708435|B1|Baseline|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487951|NCT00708435|P2|Participant Flow|Fresh Frozen Plasma|Fresh frozen plasma : Single intravenous infusion as required to treat acute major bleeding; dosage 10, 12, or 15 mL/kg depending on baseline INR and body weight.
487952|NCT00708435|P1|Participant Flow|Beriplex® P/N|Beriplex® P/N : Single intravenous infusion as required to treat acute major bleeding; dosage 25, 35 or 50 units/kg depending on baseline INR, amount of coagulation factor IX and body weight.
487953|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
488144|NCT00708942|P3|Participant Flow|Arm 3: No Intervention|
487955|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
487956|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487957|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
487958|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487959|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
487960|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487961|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
487962|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487963|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
487964|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487965|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
487966|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487967|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487968|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
487969|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487970|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
487971|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487972|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
487973|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487974|NCT00708435|E2|Reported Event|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
487975|NCT00708435|E1|Reported Event|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
487976|NCT00708461|B3|Baseline|Total|Total of all reporting groups
488032|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
487977|NCT00708461|B2|Baseline|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
487978|NCT00708461|B1|Baseline|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
487979|NCT00708461|P2|Participant Flow|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
487980|NCT00708461|P1|Participant Flow|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
487981|NCT00708461|O2|Outcome|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
487982|NCT00708461|O1|Outcome|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
487983|NCT00708461|E2|Reported Event|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
487984|NCT00708461|E1|Reported Event|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
487985|NCT00708500|B4|Baseline|Total|Total of all reporting groups
487986|NCT00708500|B3|Baseline|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487987|NCT00708500|B2|Baseline|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
487988|NCT00708500|B1|Baseline|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487989|NCT00708500|P3|Participant Flow|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
488006|NCT00708500|E1|Reported Event|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
488007|NCT00708526|B3|Baseline|Total|Total of all reporting groups
487990|NCT00708500|P2|Participant Flow|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
487991|NCT00708500|P1|Participant Flow|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487992|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487993|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
487994|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487995|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487996|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
487997|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487998|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
487999|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
488000|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
488001|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
488002|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
488003|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
488004|NCT00708500|E3|Reported Event|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
488005|NCT00708500|E2|Reported Event|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
488008|NCT00708526|B2|Baseline|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
488009|NCT00708526|B1|Baseline|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
488010|NCT00708526|P2|Participant Flow|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
488011|NCT00708526|P1|Participant Flow|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
488012|NCT00708526|O2|Outcome|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
488013|NCT00708526|O1|Outcome|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
488014|NCT00708526|O2|Outcome|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
488015|NCT00708526|O1|Outcome|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
488016|NCT00708526|E2|Reported Event|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
488017|NCT00708526|E1|Reported Event|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
488018|NCT00708643|B3|Baseline|Total|Total of all reporting groups
488019|NCT00708643|B2|Baseline|Narafilcon A|Silicone hydrogel daily disposable contact lens
488020|NCT00708643|B1|Baseline|Habitual Silicone Hydrogel|Habitual contact lens wear.
488021|NCT00708643|P2|Participant Flow|Narafilcon A|Silicone hydrogel daily disposable contact lens
488022|NCT00708643|P1|Participant Flow|Habitual Silicone Hydrogel|Habitual contact lens wear.
488023|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
488024|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
488025|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
488026|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
488027|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
488028|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
488029|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
492772|NCT00716807|B5|Baseline|Total|Total of all reporting groups
488034|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
488035|NCT00708643|E2|Reported Event|Narafilcon A|Silicone hydrogel daily disposable contact lens
488036|NCT00708643|E1|Reported Event|Habitual Silicone Hydrogel|Habitual contact lens wear.
488037|NCT00708682|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488038|NCT00708682|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488039|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488040|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488041|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488042|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488043|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488044|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488045|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488046|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488047|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488048|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488135|NCT00708877|E1|Reported Event|Transplant|The cohort was comprised of patients who received neoadjuvant chemoradiation and transplantation.
488049|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488050|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488051|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488052|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
488053|NCT00708682|E3|Reported Event|Toddler Dose 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).
Other AEs (non-serious events): the number affected (n) for non-systematic (non-solicited) Other AEs n=50; systematic (solicited) Any Local Reaction n=73; systematic (solicited) Any Systemic Event n=96."
488054|NCT00708682|E2|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
488055|NCT00708682|E1|Reported Event|Infant Series 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
Other Adverse Events (AEs) (non-serious events): the number affected (n) for non-systematic (non-solicited) Other Adverse Events n=79; systematic (solicited) Any Local Reaction n=154, 139, and 112 for Dose 1, 2,and 3 of infant series, respectively; systematic (solicited) Any Systemic Event n=182, 144, and 126 for Dose 1, 2,and 3 of infant series, respectively."
488056|NCT00708708|B1|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488057|NCT00708708|P1|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488058|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488172|NCT00709098|B3|Baseline|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488059|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488060|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488061|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488062|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488063|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488064|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488065|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488066|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488067|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488068|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488069|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488070|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488173|NCT00709098|B2|Baseline|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488336|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488071|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488072|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488073|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
488074|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
488075|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
488088|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488076|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
488077|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
488078|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
488079|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488080|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488174|NCT00709098|B1|Baseline|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
488081|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488082|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488083|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488084|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488085|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488086|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488087|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488089|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488090|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488091|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488092|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488093|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488175|NCT00709098|P3|Participant Flow|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488337|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488094|NCT00708708|O3|Outcome|Remaining Participants|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
488095|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
488096|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
488097|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488098|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488099|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488100|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488101|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488102|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488103|NCT00708708|E1|Reported Event|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
488104|NCT00708721|B1|Baseline|All Groups|
488105|NCT00708721|P4|Participant Flow|Not Evaluable|
488106|NCT00708721|P3|Participant Flow|Cohort 3: 1 mg/Day for 7 Days|1 mg/day for 7/28 days
488107|NCT00708721|P2|Participant Flow|Cohort 2: 1 mg/Day for 10 Days|1 mg/day for 10/28 days and for cycle 1 and then 1 mg/day for 7/28 days for cycle 2 onward
488108|NCT00708721|P1|Participant Flow|Cohort 1: 5 mg/Day for 10 Days|5 mg/day for 10 out of 28 days
488109|NCT00708721|O1|Outcome|All Patients|All participants enrolled.
488110|NCT00708721|O1|Outcome|All Patients|All participants enrolled.
488111|NCT00708721|O1|Outcome|All Patients|All participants enrolled.
488112|NCT00708721|O1|Outcome|All Evaluable Patients|All evaluable patients. Eleven patients were enrolled, but only nine were evaluable.
488113|NCT00708721|O1|Outcome|All Evaluable Patients|Only nine of the eleven patients were evaluable for this outcome measure.
496785|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
488114|NCT00708721|O1|Outcome|All Evaluable Patients|"All participants enrolled.
Clofarabine: Clofarabine is a rationally designed, second generation purine nucleoside analogue. Clofarabine was designed as a hybrid molecule to overcome the limitations and incorporate the best qualities of both fludarabine (F-ara-A) and cladribine (2-CdA, CdA) both of which are currently approved by various regulatory authorities for treatment of hematologic malignancies."
488115|NCT00708721|O4|Outcome|Not Evaluable|
488116|NCT00708721|O3|Outcome|Cohort 3: 1 mg/Day for 7 Days|
488117|NCT00708721|O2|Outcome|Cohort 2: 1 mg/Day for 10 Days|
488118|NCT00708721|O1|Outcome|Cohort 1: 10 mg/Day for 10 Days|
488119|NCT00708721|E1|Reported Event|All Groups|All patients who received study treatment.
488120|NCT00708734|B1|Baseline|Functional Exercise Training|"functional exercise training
functional exercise training: twice weekly group sessions for 5 weeks"
488121|NCT00708734|P1|Participant Flow|Arm 1|"functional exercise training
functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise."
488122|NCT00708734|O1|Outcome|Composite Measures of Gait and Balance|Measurement of gait and balance using standardized tools
488123|NCT00708734|E1|Reported Event|Functional Exercise Training|"functional exercise training
functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise."
488124|NCT00708851|B1|Baseline|NB-UVB Alone|"One leg receives NB-UVB Alone: NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week
Opposite leg receives: LCD therapy 2 applications/day and NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy 3 light exposures / week"
488125|NCT00708851|P1|Participant Flow|NB-UVB and NB-UVB+LCD|"NB-UVB Alone: NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy: 3 light exposures / week
NB-UVB+LCD: 2 applications of LCD/day + NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy 3 light exposures / week"
488126|NCT00708851|O2|Outcome|LCD+NB-UVB|"LCD+NB-UVB
LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day
NB-UVB Phototherapy: 3 light sessions / week"
488127|NCT00708851|O1|Outcome|NB-UVB Alone|"NB-UVB Alone
NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
488128|NCT00708851|O2|Outcome|LCD+NB-UVB|"LCD+NB-UVB
LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day
NB-UVB Phototherapy: 3 light sessions / week"
488129|NCT00708851|O1|Outcome|NB-UVB Alone|"NB-UVB Alone
NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
488130|NCT00708851|E2|Reported Event|LCD+NB-UVB|"LCD+NB-UVB
LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day
NB-UVB Phototherapy: 3 light sessions / week"
488131|NCT00708851|E1|Reported Event|NB-UVB Alone|"NB-UVB Alone
NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
488132|NCT00708877|B1|Baseline|Transplant|All patients enrolled in study.
488133|NCT00708877|P1|Participant Flow|Transplant|All patients enrolled in study.
488134|NCT00708877|O1|Outcome|Transplant|The cohort was comprised of patients who received neoadjuvant chemoradiation and transplantation.
488136|NCT00708942|B6|Baseline|Total|Total of all reporting groups
488145|NCT00708942|P2|Participant Flow|Arm 2: Placebo Suppository, Laser Illumination|
488146|NCT00708942|P1|Participant Flow|Arm 1: HAL Suppository, Laser Illumination|
488147|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
488148|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
488149|NCT00708942|O3|Outcome|Arm 3: No Intervention|
488150|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
488151|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
488152|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
488153|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
488154|NCT00708942|O3|Outcome|Arm 3: No Intervention|
488155|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
488156|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
488157|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
488158|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
488159|NCT00708942|O3|Outcome|Arm 3: No Intervention|
488160|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
488161|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
488162|NCT00708942|E5|Reported Event|Arm 5: Placebo Ointment, no Illumination|
488163|NCT00708942|E4|Reported Event|Arm 4: HAL Ointment, LED Diode Illumination|
488164|NCT00708942|E3|Reported Event|Arm 3: No Intervention|
488165|NCT00708942|E2|Reported Event|Arm 2: Placebo Suppository, Laser Illumination|
488166|NCT00708942|E1|Reported Event|Arm 1: HAL Suppository, Laser Illumination|
488167|NCT00709059|B1|Baseline|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
488168|NCT00709059|P1|Participant Flow|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
488169|NCT00709059|O1|Outcome|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
488170|NCT00709059|E1|Reported Event|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
488171|NCT00709098|B4|Baseline|Total|Total of all reporting groups
489417|NCT00712244|E3|Reported Event|Healon5|Healon5 Ophthalmic Viscosurgical Device
488176|NCT00709098|P2|Participant Flow|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488177|NCT00709098|P1|Participant Flow|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
488178|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488179|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 6 disc
488180|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488181|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488182|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
488183|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488184|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488185|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
488186|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488187|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488188|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
488189|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488190|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488191|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
488192|NCT00709098|E3|Reported Event|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
496279|NCT00725361|O1|Outcome|Active|"Ambrisentan
Ambrisentan"
488193|NCT00709098|E2|Reported Event|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
488194|NCT00709098|E1|Reported Event|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
488195|NCT00709111|B1|Baseline|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488196|NCT00709111|P1|Participant Flow|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488197|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488198|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488199|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488200|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488201|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488202|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488203|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488204|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488338|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488205|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488206|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488207|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488208|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488209|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488210|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488211|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488212|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488213|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488214|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488215|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488216|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488217|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488264|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
488218|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488219|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488220|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488221|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488222|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488223|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488224|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488225|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488226|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488227|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488228|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488339|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
489418|NCT00712244|E2|Reported Event|DUOVISC|DUOVISC® Viscoelastic system
488229|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488230|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488231|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488232|NCT00709111|E1|Reported Event|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
488233|NCT00709124|B3|Baseline|Total|Total of all reporting groups
488234|NCT00709124|B2|Baseline|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.
Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
488235|NCT00709124|B1|Baseline|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.
Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
488236|NCT00709124|P2|Participant Flow|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.
Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
488237|NCT00709124|P1|Participant Flow|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.
Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
488238|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.
Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
488239|NCT00709124|O1|Outcome|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.
Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
488265|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
488266|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
488240|NCT00709124|E2|Reported Event|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.
Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
488241|NCT00709124|E1|Reported Event|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.
Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
488242|NCT00709228|B1|Baseline|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative HCV-RNA at Week 4 and at Week 24 (n = 170)
488243|NCT00709228|P1|Participant Flow|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
488244|NCT00709228|O1|Outcome|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
488245|NCT00709228|E1|Reported Event|PegInton Plus Rebetol|
488246|NCT00709319|B1|Baseline|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
488247|NCT00709319|P1|Participant Flow|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
488333|NCT00709852|O1|Outcome|Combined Gadobutrol vs. Combined Gadoteridol|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488248|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
488249|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
488250|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
488251|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
488252|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
488253|NCT00709319|E1|Reported Event|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
488254|NCT00709592|B3|Baseline|Total|Total of all reporting groups
488255|NCT00709592|B2|Baseline|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
488256|NCT00709592|B1|Baseline|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
488257|NCT00709592|P2|Participant Flow|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
488258|NCT00709592|P1|Participant Flow|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
488259|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
488260|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
488261|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
488262|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
488263|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
496280|NCT00725361|O1|Outcome|Active|"Ambrisentan
Ambrisentan"
488267|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
488268|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
488269|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
488270|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
488271|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
488272|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
488273|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
488274|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
488275|NCT00709592|E2|Reported Event|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
488276|NCT00709592|E1|Reported Event|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
488277|NCT00709618|B1|Baseline|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
488278|NCT00709618|P1|Participant Flow|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 milligrams per meters squared [mg/m^2]) intravenously (IV) once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
488279|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
488280|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
488281|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
488282|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
488283|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
488284|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
488285|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
488286|NCT00709618|E1|Reported Event|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
488287|NCT00709722|B1|Baseline|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
488288|NCT00709722|P1|Participant Flow|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
488289|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
488290|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
488291|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
488292|NCT00709722|E1|Reported Event|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
488293|NCT00709735|B3|Baseline|Total|Total of all reporting groups
488294|NCT00709735|B2|Baseline|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
488295|NCT00709735|B1|Baseline|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
488296|NCT00709735|P2|Participant Flow|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
488317|NCT00709826|P1|Participant Flow|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
488318|NCT00709826|O2|Outcome|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
496281|NCT00725361|O1|Outcome|Active|"Ambrisentan
Ambrisentan"
488297|NCT00709735|P1|Participant Flow|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
488298|NCT00709735|O2|Outcome|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
488299|NCT00709735|O1|Outcome|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
488300|NCT00709735|O2|Outcome|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
488301|NCT00709735|O1|Outcome|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
488334|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488335|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
497122|NCT00729807|P1|Participant Flow|Treatment Arm|
488302|NCT00709735|E2|Reported Event|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
488303|NCT00709735|E1|Reported Event|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
488304|NCT00709761|B1|Baseline|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
488305|NCT00709761|P1|Participant Flow|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
488306|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
488307|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
488308|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
488309|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
488310|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
488311|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
488312|NCT00709761|E1|Reported Event|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
488313|NCT00709826|B3|Baseline|Total|Total of all reporting groups
488314|NCT00709826|B2|Baseline|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
488315|NCT00709826|B1|Baseline|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
488316|NCT00709826|P2|Participant Flow|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
488319|NCT00709826|O1|Outcome|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
488320|NCT00709826|O2|Outcome|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
488321|NCT00709826|O1|Outcome|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
488322|NCT00709826|E2|Reported Event|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
488323|NCT00709826|E1|Reported Event|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
488324|NCT00709852|B1|Baseline|Entire Study Population|Includes participants who received either treatment
488325|NCT00709852|P2|Participant Flow|Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875)|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.
488326|NCT00709852|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance)|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2.
488327|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488328|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488329|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488330|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488331|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488332|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
497123|NCT00729807|O1|Outcome|Treatment Arm|Pentamidine
488340|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488341|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488342|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488343|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488344|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488345|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488346|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488347|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488348|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488349|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488350|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488351|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488352|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488353|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488354|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488355|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488356|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488357|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488358|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488359|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488360|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488361|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488362|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488363|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488364|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488365|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488366|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488367|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488368|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488369|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488370|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488371|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488372|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488373|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488374|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488375|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488376|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488377|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488378|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488379|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488380|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488381|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488382|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488383|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488384|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
489419|NCT00712244|E1|Reported Event|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
488385|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488386|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488387|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488388|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488389|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488390|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488391|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488392|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488393|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488394|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488395|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488396|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488397|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488398|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488399|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488400|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488401|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488402|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488403|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488404|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488405|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488406|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488407|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
496282|NCT00725361|E1|Reported Event|Active|"Ambrisentan
Ambrisentan"
488408|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488409|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488410|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488411|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488412|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488413|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488414|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488415|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488416|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488417|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488418|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488419|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488420|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488421|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488422|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488423|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488424|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488425|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488426|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488427|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488428|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488429|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
489420|NCT00712335|B6|Baseline|Total|Total of all reporting groups
488430|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488431|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488432|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488433|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488434|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488435|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488436|NCT00709852|O2|Outcome|Gadoteridol-enhanced Compared to Gadobutrol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
488437|NCT00709852|O1|Outcome|Gadobutrol-enhanced Compared to Gadoteridol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
488438|NCT00709852|O2|Outcome|Gadoteridol-enhanced Compared to Unenhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Unenhanced MRI.
488439|NCT00709852|O1|Outcome|Unenhanced Compared to Gadoteridol-enhanced|Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
488440|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced Compared to Unenhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous). Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Unenhanced MRI.
488441|NCT00709852|O1|Outcome|Unenhanced Compared to Combined Unenhanced/Gadobutrol-enhanced|Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
488442|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488443|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488444|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488445|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
488446|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488447|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488448|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488449|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488450|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488451|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488452|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488453|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488454|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488455|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488456|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488457|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488458|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488459|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488460|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488461|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488462|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488463|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488464|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488465|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488466|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488467|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488468|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488469|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488470|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488471|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488472|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488473|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488474|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488475|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
488476|NCT00709852|E2|Reported Event|Gadoteridol (ProHance)|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
488477|NCT00709852|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
488478|NCT00709878|B5|Baseline|Total|Total of all reporting groups
488479|NCT00709878|B4|Baseline|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
488480|NCT00709878|B3|Baseline|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
488481|NCT00709878|B2|Baseline|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
488482|NCT00709878|B1|Baseline|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
488483|NCT00709878|P4|Participant Flow|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
488484|NCT00709878|P3|Participant Flow|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
488485|NCT00709878|P2|Participant Flow|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
488486|NCT00709878|P1|Participant Flow|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
488487|NCT00709878|O4|Outcome|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
488488|NCT00709878|O3|Outcome|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
488489|NCT00709878|O2|Outcome|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
488490|NCT00709878|O1|Outcome|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
488491|NCT00709878|E4|Reported Event|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
488492|NCT00709878|E3|Reported Event|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
488493|NCT00709878|E2|Reported Event|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
488494|NCT00709878|E1|Reported Event|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
488495|NCT00709891|B1|Baseline|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
488496|NCT00709891|P1|Participant Flow|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
488497|NCT00709891|O1|Outcome|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
488498|NCT00709891|O1|Outcome|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
488499|NCT00709891|E1|Reported Event|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
488500|NCT00709956|B3|Baseline|Total|Total of all reporting groups
488501|NCT00709956|B2|Baseline|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
488502|NCT00709956|B1|Baseline|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
488503|NCT00709956|P2|Participant Flow|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
488504|NCT00709956|P1|Participant Flow|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
488505|NCT00709956|O2|Outcome|Borg Dyspnea Score After Iloprost (5 µg) Treatment|
488506|NCT00709956|O1|Outcome|Borg Dyspnea Score After Placebo Treatment|
488507|NCT00709956|O2|Outcome|6MWD After Iloprost (5 µg) Treatment|
488508|NCT00709956|O1|Outcome|6MWD After Placebo Treatment|
488509|NCT00709956|E2|Reported Event|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
488510|NCT00709956|E1|Reported Event|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
488511|NCT00710021|B4|Baseline|Total|Total of all reporting groups
488512|NCT00710021|B3|Baseline|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488761|NCT00710593|O1|Outcome|All Study Participants|The results are reported for participants in both Group A and Group B.
488513|NCT00710021|B2|Baseline|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488514|NCT00710021|B1|Baseline|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488515|NCT00710021|P3|Participant Flow|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488516|NCT00710021|P2|Participant Flow|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488517|NCT00710021|P1|Participant Flow|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488518|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488519|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488520|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488521|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488522|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488523|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488524|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488525|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488526|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488527|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488528|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488529|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488530|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488531|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488532|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488533|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488534|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488535|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488536|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488537|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488538|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488539|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488540|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488541|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488542|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488543|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488544|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488545|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488546|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488547|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488548|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488549|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488550|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488551|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488552|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488553|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488554|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488555|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488556|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488557|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488558|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488559|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488560|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488561|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488562|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488563|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488564|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488565|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488566|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488567|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488568|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488569|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488570|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488571|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488963|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
488572|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488573|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488574|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488575|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488576|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488577|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488578|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488579|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488580|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488581|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488582|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488583|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488584|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488585|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488586|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488587|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488588|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488589|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
497124|NCT00729807|E1|Reported Event|Treatment Arm|Pentamidine
488590|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488591|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488592|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488593|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488594|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488595|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488596|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488597|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488598|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488599|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488600|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488601|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488602|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488603|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488604|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488605|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488606|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488607|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488608|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488609|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488718|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488610|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488611|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488612|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488613|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488614|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488615|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488616|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488617|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488618|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488619|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488620|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488621|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488622|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
488623|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488624|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488625|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488626|NCT00710021|E3|Reported Event|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
488627|NCT00710021|E2|Reported Event|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
488628|NCT00710021|E1|Reported Event|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
488629|NCT00710203|B1|Baseline|Study Arm|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.
488630|NCT00710203|P1|Participant Flow|Study Arm|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.
488631|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
488632|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
488633|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
488634|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
488635|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
488636|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
488637|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
488638|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
488639|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
488640|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
488641|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
488719|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488642|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
488643|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
488644|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
488645|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
488646|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
488647|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
488648|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
488649|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
488650|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
488651|NCT00710203|E4|Reported Event|No Treatment|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
488652|NCT00710203|E3|Reported Event|Electrodesiccation|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
488653|NCT00710203|E2|Reported Event|Curettage|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
488762|NCT00710593|O1|Outcome|All Study Participants|The results are reported for participants in both Group A and Group B.
489421|NCT00712335|B5|Baseline|Normal Controls|Normal controls did not receive any treatment.
488654|NCT00710203|E1|Reported Event|Pulsed Dye Laser|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
488655|NCT00710385|B1|Baseline|Challenge Doses|This study employs a within-subjects design, all participant experience all challenge doses.
488656|NCT00710385|P1|Participant Flow|Intravenous Challenge Doses|This study employs a within-subjects design, all participants experienced all 7 intravenous challenge doses. The challenge doses were administered under 3 sublingual buprenorphine maintenance conditions. The data presented were collapsed across the 3 sublingual groups.
488657|NCT00710385|O7|Outcome|Placebo|Control intravenous placebo drug administration.
488658|NCT00710385|O6|Outcome|High Bup/Nal Dose|Higher doses of intravenous buprenorphine +naloxone
488659|NCT00710385|O5|Outcome|Lower Bup/Nal Dose|Lower doses of intravenous buprenorphine + naloxone.
488660|NCT00710385|O4|Outcome|High Bup Dose|Higher doses of intravenous buprenorphine
488661|NCT00710385|O3|Outcome|Low Bup Dose|Lower doses of intravenous buprenorphine alone.
488662|NCT00710385|O2|Outcome|Naloxone|Intravenous Naloxone HCl
488663|NCT00710385|O1|Outcome|Heroin|Intravenous heroin 25 mg
488664|NCT00710385|O7|Outcome|Placebo|Control intravenous placebo drug administration.
488665|NCT00710385|O6|Outcome|High Bup/Nal Dose|Higher doses of intravenous buprenorphine +naloxone
488666|NCT00710385|O5|Outcome|Lower Bup/Nal Dose|Lower doses of intravenous buprenorphine + naloxone.
488667|NCT00710385|O4|Outcome|High Bup Dose|Higher doses of intravenous buprenorphine
488668|NCT00710385|O3|Outcome|Low Bup Dose|Lower doses of intravenous buprenorphine alone.
488669|NCT00710385|O2|Outcome|Naloxone|Intravenous Naloxone HCl
488670|NCT00710385|O1|Outcome|Heroin|Intravenous heroin 25 mg
488671|NCT00710385|E1|Reported Event|Combined for All Study Conditions|This study employed a within-subjects design, all participants experienced all study conditions.
488672|NCT00710424|B3|Baseline|Total|Total of all reporting groups
488673|NCT00710424|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488674|NCT00710424|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488675|NCT00710424|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488676|NCT00710424|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488677|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488678|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488679|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488720|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488680|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488681|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488682|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488683|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488684|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488685|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488686|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488687|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488688|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488689|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488690|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488691|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488692|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488693|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488763|NCT00710593|O1|Outcome|All Study Participants|The results are reported for all study participants in both Group A and Group B.
488694|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488695|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488696|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488697|NCT00710424|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
488698|NCT00710424|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
488699|NCT00710554|B3|Baseline|Total|Total of all reporting groups
488700|NCT00710554|B2|Baseline|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488701|NCT00710554|B1|Baseline|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488702|NCT00710554|P2|Participant Flow|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488703|NCT00710554|P1|Participant Flow|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488704|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488705|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488706|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488707|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488708|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488709|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488710|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488711|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488712|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488713|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488714|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488715|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488716|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488717|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488785|NCT00702468|B3|Baseline|Total|Total of all reporting groups
488721|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488722|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488723|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488724|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488725|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488726|NCT00710554|E2|Reported Event|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
488727|NCT00710554|E1|Reported Event|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
488728|NCT00710593|B3|Baseline|Total|Total of all reporting groups
488729|NCT00710593|B2|Baseline|Group B|Participants who have been receiving highly active retroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
488730|NCT00710593|B1|Baseline|Group A|Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy(HAART) for at least the six months prior to study entry.
488731|NCT00710593|P2|Participant Flow|HAART|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
488732|NCT00710593|P1|Participant Flow|ART/HAART NAIVE|Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
488733|NCT00710593|O2|Outcome|Vaccine Report Card (VRC)|Participants at sites randomized to the VRC recorded any of their side effects.
488734|NCT00710593|O1|Outcome|Telephone Response System (TRS)|Participants at sites randomized to the TRS called the TRS once a day to report any side effects they were experiencing.
488764|NCT00710593|O1|Outcome|All Study Participants|All study participants who were administered vaccine doses #1, 2, and/or 3.
488765|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
488735|NCT00710593|O2|Outcome|Vaccine Report Card (VRC)|Participants at sites randomized to the VRC recorded any of their side effects. Participants were directed to call the clinical site staff or return to the clinic for evaluation if they were concerned about their signs or symptoms or if any symptoms appeared severe. Participants brought their VRC with them to all of their study visits. The completed cards were collected after all vaccine study visits were completed.
488736|NCT00710593|O1|Outcome|Telephone Response System (TRS)|Participants at sites randomized to the TRS called the TRS once a day to report any side effects they were experiencing.
488737|NCT00710593|O2|Outcome|Higher NSSB|Higher NSSB is defined as participants who had a higher need for safer sexual behaviors (summary score is equal to or greater than the median).
488738|NCT00710593|O1|Outcome|Lower NSSB|Lower NSSB is defined as participants who had a lower need for safer sexual behaviors (summary score is less than the median).
488739|NCT00710593|O2|Outcome|Higher NSSB|Higher NSSB is defined as participants who had a higher need for safer sexual behaviors (summary score is equal to or greater than the median).
488740|NCT00710593|O1|Outcome|Lower NSSB|Lower NSSB is defined as participants who had a lower need for safer sexual behaviors (summary score is less than the median).
488741|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
488742|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
488743|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
488744|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
488745|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
488746|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
488747|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
488748|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
488749|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
488750|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
488751|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
488752|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
496283|NCT00727337|B5|Baseline|Total|Total of all reporting groups
488753|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
488754|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
488755|NCT00710593|O2|Outcome|Group B|Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
488756|NCT00710593|O1|Outcome|Group A|Antiretroviral therapy (ART) naïve or if ART exposed, have not received highlight active antiretroviral (HAART) for at least the six months prior to study entry.
488757|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-18 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.
Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
488758|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-16 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.
Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
488759|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-11 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.
Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
488760|NCT00710593|O1|Outcome|All Study Participants|The results are reported for participants in both Group A and Group B.
497125|NCT00721253|B3|Baseline|Total|Total of all reporting groups
488766|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
488767|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
488768|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
488769|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-6 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.
Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
488770|NCT00710593|E2|Reported Event|Group B: Has Been Receiving HAART for > 6 Months, With Two HIV|Participants who have been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
488771|NCT00710593|E1|Reported Event|Group A: HAART naïve or, if HAART Exposed, Has Not Received HA|Participants who are ART naïve or, if ART-exposed, have not received HAART for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
488772|NCT00710606|B3|Baseline|Total|Total of all reporting groups
488773|NCT00710606|B2|Baseline|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
488774|NCT00710606|B1|Baseline|Obese Subjects|Obese subjects (BMI 30-39.9)
488775|NCT00710606|P2|Participant Flow|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
488776|NCT00710606|P1|Participant Flow|Obese Subjects|Obese subjects (BMI 30-39.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
488777|NCT00710606|O2|Outcome|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
488778|NCT00710606|O1|Outcome|Obese Subjects|Obese subjects (BMI 30-39.9)
488779|NCT00710606|O2|Outcome|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
488780|NCT00710606|O1|Outcome|Obese Subjects|Obese subjects (BMI 30-39.9)
488781|NCT00710606|O2|Outcome|Obese|Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
488782|NCT00710606|O1|Outcome|Normal Weight|Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
488783|NCT00710606|E2|Reported Event|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
488784|NCT00710606|E1|Reported Event|Obese Subjects|Obese subjects (BMI 30-39.9)
488786|NCT00702468|B2|Baseline|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488787|NCT00702468|B1|Baseline|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488788|NCT00702468|P2|Participant Flow|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488789|NCT00702468|P1|Participant Flow|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488790|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488791|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488792|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488793|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488794|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488795|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488796|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488797|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488798|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488799|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488800|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488801|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488802|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488803|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488804|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488805|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488806|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488807|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488808|NCT00702468|E2|Reported Event|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
488809|NCT00702468|E1|Reported Event|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
488810|NCT00702507|B1|Baseline|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
488920|NCT00702702|O2|Outcome|50 mg|Proellex 50 mg, 1 - 50 mg capsule and 1 placebo capsule daily for 3 months
488811|NCT00702507|P1|Participant Flow|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
488812|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
488813|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
488814|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
488815|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
488816|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
488817|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
488818|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
488976|NCT00710840|B2|Baseline|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
488819|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
488820|NCT00702507|E2|Reported Event|Vusion Follow-up Phase|After the Initial Treatment Phase participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment containing 0.25 percent miconazole nitrate.
488821|NCT00702507|E1|Reported Event|Vusion Initial Treatment Phase|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14.
488822|NCT00702520|B3|Baseline|Total|Total of all reporting groups
488823|NCT00702520|B2|Baseline|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
488824|NCT00702520|B1|Baseline|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
488825|NCT00702520|P4|Participant Flow|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
488826|NCT00702520|P3|Participant Flow|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
488827|NCT00702520|P2|Participant Flow|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
488828|NCT00702520|P1|Participant Flow|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
488829|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
488830|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
488962|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
488831|NCT00702520|O2|Outcome|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
488832|NCT00702520|O1|Outcome|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
488833|NCT00702520|O2|Outcome|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
488834|NCT00702520|O1|Outcome|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
488835|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
488836|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
488837|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
488838|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
489007|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
488839|NCT00702520|E4|Reported Event|Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug|Fetuses/Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
488840|NCT00702520|E3|Reported Event|Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug|Fetuses/Infants from mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
488841|NCT00702520|E2|Reported Event|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
488842|NCT00702520|E1|Reported Event|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the P05783 study (38834, NCT00702520).
488843|NCT00702546|B3|Baseline|Total|Total of all reporting groups
488844|NCT00702546|B2|Baseline|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
488845|NCT00702546|B1|Baseline|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
488875|NCT00702624|O2|Outcome|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
488846|NCT00702546|P2|Participant Flow|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
488847|NCT00702546|P1|Participant Flow|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
488848|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
489008|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
488849|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
488850|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
488851|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
488852|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
488853|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
496852|NCT00728988|B3|Baseline|Total|Total of all reporting groups
488854|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
488855|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
488856|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
489009|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
488857|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
488858|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
488859|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
488860|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
488861|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
488889|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488862|NCT00702546|E2|Reported Event|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
488863|NCT00702546|E1|Reported Event|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
488864|NCT00702624|B3|Baseline|Total|Total of all reporting groups
488865|NCT00702624|B2|Baseline|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
488866|NCT00702624|B1|Baseline|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
488867|NCT00702624|P4|Participant Flow|recFSH 150 IU Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
488868|NCT00702624|P3|Participant Flow|Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
488869|NCT00702624|P2|Participant Flow|recFSH 150 IU Women/Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
488870|NCT00702624|P1|Participant Flow|Corifollitropin Alfa 100 μg Women/Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
488871|NCT00702624|O2|Outcome|recFSH 150 IU Follow-Up Infants|Infants that were born to eligible mothers who received SC recFSH plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
488872|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Follow-Up Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
488873|NCT00702624|O2|Outcome|recFSH 150 IU Follow-Up Infants|Infants that were born to eligible mothers who received SC recFSH plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
488874|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Follow-Up Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
498381|NCT00732160|O1|Outcome|Vehicle, HS|Vehicle Infusion, High Salt diet
488876|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
488877|NCT00702624|O2|Outcome|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
488878|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
489010|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
489011|NCT00710866|E2|Reported Event|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
488879|NCT00702624|O2|Outcome|recFSH 150 IU Women|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
488880|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Women|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
488881|NCT00702624|E4|Reported Event|recFSH 150 IU Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
488882|NCT00702624|E3|Reported Event|Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
488883|NCT00702624|E2|Reported Event|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
488884|NCT00702624|E1|Reported Event|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
488885|NCT00702650|B1|Baseline|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488886|NCT00702650|P1|Participant Flow|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488887|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488888|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488890|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488891|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488892|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488893|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488894|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488895|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488896|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488897|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488898|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488899|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488900|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488901|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488902|NCT00702650|E1|Reported Event|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
488903|NCT00702689|B1|Baseline|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
489012|NCT00710866|E1|Reported Event|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
488904|NCT00702689|P1|Participant Flow|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
488905|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
488906|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
488907|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
488908|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
488909|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
488910|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
488911|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
488912|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
488913|NCT00702689|E1|Reported Event|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
488914|NCT00702702|B4|Baseline|Total|Total of all reporting groups
488915|NCT00702702|B3|Baseline|Placebo|Placebo, 2 placebo capsules daily for 3 months
488916|NCT00702702|B2|Baseline|50 mg|Proellex 50 mg, 1 - 50 mg capsule and 1 placebo capsule daily for 3 months
488917|NCT00702702|B1|Baseline|25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
488918|NCT00702702|P1|Participant Flow|All Groups|Proellex 25 mg, 50 mg or placebo
488919|NCT00702702|O3|Outcome|Placebo|Placebo, 2 placebo capsules daily for 3 months
488921|NCT00702702|O1|Outcome|25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
488922|NCT00702702|E3|Reported Event|C Placebo|Placebo, 2 capsules daily for 3 months
488923|NCT00702702|E2|Reported Event|B 50 mg|Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
488924|NCT00702702|E1|Reported Event|A 25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
488925|NCT00702715|B3|Baseline|Total|Total of all reporting groups
488926|NCT00702715|B2|Baseline|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
488927|NCT00702715|B1|Baseline|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
488928|NCT00702715|P2|Participant Flow|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
488929|NCT00702715|P1|Participant Flow|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 post-tetanic counts (PTC). Severe renal impairment was defined as creatinine clearance <30mL/min.
488930|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
488931|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
489013|NCT00710879|B3|Baseline|Total|Total of all reporting groups
488932|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
488933|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
488934|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
488935|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
488936|NCT00702715|E2|Reported Event|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
488937|NCT00702715|E1|Reported Event|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
488938|NCT00710749|B1|Baseline|Entire Study Population|Includes groups randomized to use the Disposable device first and the Digital device first.
488939|NCT00710749|P2|Participant Flow|Digital Device First, Then Disposable Device|12 voidings recorded with the digital device in the first intervention period, followed by 12 voidings recorded with the disposable device in the second intervention period.
488940|NCT00710749|P1|Participant Flow|Disposable Device First, Then Digital Device|12 voidings recorded with the disposable device in the first intervention period, followed by 12 voidings recorded with the digital device in the second intervention period.
488941|NCT00710749|O3|Outcome|Digital Device|Voidings recorded with the digital device in either first intervention period or second intervention period.
488942|NCT00710749|O2|Outcome|Clinic|Voidings recorded with the clinic gold standard.
488943|NCT00710749|O1|Outcome|Disposable Device|Voidings recorded with the disposable device in either first intervention period or second intervention period.
488944|NCT00710749|E3|Reported Event|Digital Device|Voidings recorded with the digital device in either first intervention period or second intervention period.
488945|NCT00710749|E2|Reported Event|Clinic|Voidings recorded with the clinic gold standard.
488946|NCT00710749|E1|Reported Event|Disposable Device|Voidings recorded with the disposable device in either first intervention period or second intervention period.
488947|NCT00710762|B3|Baseline|Total|Total of all reporting groups
488948|NCT00710762|B2|Baseline|Placebo|Patients were treated with matching placebo twice daily
488949|NCT00710762|B1|Baseline|Nintedanib|Patients were treated with 250mg nintedanib twice daily
488950|NCT00710762|P2|Participant Flow|Placebo|Patients were treated with matching placebo twice daily
488951|NCT00710762|P1|Participant Flow|Nintedanib|Patients were treated with 250mg nintedanib twice daily
488952|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
488953|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
488954|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
488955|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
488956|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
488957|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
488958|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
488959|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
488960|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
488961|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
488964|NCT00710762|E2|Reported Event|Placebo|Patients were treated with matching placebo twice daily.
488965|NCT00710762|E1|Reported Event|Nintedanib|Patients were treated with 250mg nintedanib twice daily.
488966|NCT00710814|B3|Baseline|Total|Total of all reporting groups
488967|NCT00710814|B2|Baseline|Placebo - Leptin|Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.
488968|NCT00710814|B1|Baseline|Leptin - Placebo|Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.
488969|NCT00710814|P2|Participant Flow|Placebo-Leptin|Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.
488970|NCT00710814|P1|Participant Flow|Leptin-Placebo|Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.
488971|NCT00710814|O2|Outcome|Placebo Intervention|"Participants in the Placebo-Leptin arm were randomized to receive placebo for the first 16 weeks, and participants in the Leptin-Placebo arm were randomized to receive placebo for the second 16 weeks.
Both Leptin and placebo were self-administered subcutaneously twice per day."
488972|NCT00710814|O1|Outcome|Leptin Intervention|"Participants in the Leptin-Placebo arm were randomized to first receive Leptin for the first 16 weeks, and participants in the Placebo-Leptin arm were randomized to receive Leptin for the second 16 weeks.
Both Leptin and placebo were self-administered subcutaneously twice per day."
488973|NCT00710814|E2|Reported Event|Placebo Intervention|"This group Placebo Intervention inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Placebo only."
488974|NCT00710814|E1|Reported Event|Leptin Intervention|"This group Leptin Intervention inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Leptin only."
488975|NCT00710840|B3|Baseline|Total|Total of all reporting groups
489045|NCT00710944|E2|Reported Event|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
488977|NCT00710840|B1|Baseline|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
488978|NCT00710840|P2|Participant Flow|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
488979|NCT00710840|P1|Participant Flow|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
488980|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
488981|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
488982|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
488983|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
488984|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
488985|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
488986|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
488987|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
488988|NCT00710840|E2|Reported Event|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
489030|NCT00710931|B1|Baseline|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
498770|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
488989|NCT00710840|E1|Reported Event|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
488990|NCT00710866|B3|Baseline|Total|Total of all reporting groups
488991|NCT00710866|B2|Baseline|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
488992|NCT00710866|B1|Baseline|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
488993|NCT00710866|P2|Participant Flow|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
488994|NCT00710866|P1|Participant Flow|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
488995|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
488996|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
488997|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
488998|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
488999|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
489000|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
489001|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
489002|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
489003|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
489004|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
489005|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
489006|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
498398|NCT00732199|O1|Outcome|Healthy Young Adults|Young adults
489014|NCT00710879|B2|Baseline|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
489015|NCT00710879|B1|Baseline|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
489016|NCT00710879|P2|Participant Flow|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
489017|NCT00710879|P1|Participant Flow|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
489018|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
489019|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
489020|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
489021|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
489022|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
489023|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
489024|NCT00710879|E2|Reported Event|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
489025|NCT00710879|E1|Reported Event|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
489026|NCT00710905|B1|Baseline|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
489027|NCT00710905|P1|Participant Flow|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
489028|NCT00710905|O1|Outcome|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
489029|NCT00710905|E1|Reported Event|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
489031|NCT00710931|P1|Participant Flow|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
489032|NCT00710931|O1|Outcome|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
489033|NCT00710931|E1|Reported Event|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
489034|NCT00710944|B4|Baseline|Total|Total of all reporting groups
489035|NCT00710944|B3|Baseline|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
489036|NCT00710944|B2|Baseline|Healed Ridges|"Immediate loading of implants placed in healed ridges.
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
489037|NCT00710944|B1|Baseline|Extraction Sockets|"Immediate loading of implants placed in extraction sockets.
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
489038|NCT00710944|P3|Participant Flow|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).
OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
489039|NCT00710944|P2|Participant Flow|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
489040|NCT00710944|P1|Participant Flow|Extraction Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
489041|NCT00710944|O3|Outcome|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).
OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
489042|NCT00710944|O2|Outcome|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
489043|NCT00710944|O1|Outcome|Extraction Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
489044|NCT00710944|E3|Reported Event|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).
OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
491503|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
489046|NCT00710944|E1|Reported Event|Extractions Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
489047|NCT00710970|B1|Baseline|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
489048|NCT00710970|P1|Participant Flow|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
489049|NCT00710970|O1|Outcome|Single Arm Receiving 20 mg Tamoxifen|
489050|NCT00710970|E1|Reported Event|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
489051|NCT00710996|B4|Baseline|Total|Total of all reporting groups
489052|NCT00710996|B3|Baseline|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
489053|NCT00710996|B2|Baseline|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
489054|NCT00710996|B1|Baseline|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
489055|NCT00710996|P3|Participant Flow|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
489056|NCT00710996|P2|Participant Flow|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
489057|NCT00710996|P1|Participant Flow|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
489058|NCT00710996|O3|Outcome|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
489059|NCT00710996|O2|Outcome|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
489060|NCT00710996|O1|Outcome|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
489061|NCT00710996|E3|Reported Event|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
489062|NCT00710996|E2|Reported Event|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
489063|NCT00710996|E1|Reported Event|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
489064|NCT00711009|B3|Baseline|Total|Total of all reporting groups
489065|NCT00711009|B2|Baseline|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489066|NCT00711009|B1|Baseline|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489067|NCT00711009|P2|Participant Flow|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489068|NCT00711009|P1|Participant Flow|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489069|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489070|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489071|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489072|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489073|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489074|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489075|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489076|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489077|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489078|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489079|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489080|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489081|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489082|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489083|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489084|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489085|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489086|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489087|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489088|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489089|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489090|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489091|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489092|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489093|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489094|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489095|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489096|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489097|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489098|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489099|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489100|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489101|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489102|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489103|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489104|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489105|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489106|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489107|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489108|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489109|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489110|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489111|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489112|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489113|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489114|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489115|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489116|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489117|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489118|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489119|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489120|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489121|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489122|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489123|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489124|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489125|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489126|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489127|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489128|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489129|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489130|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489131|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489132|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489133|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489134|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489135|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489136|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489137|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489138|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489139|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489140|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489141|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489142|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489143|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489144|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489145|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489146|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489147|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489148|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489149|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489150|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489151|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489152|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489153|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489154|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489155|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489156|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489157|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489158|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489159|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489160|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489161|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489162|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489163|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489164|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489165|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489166|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489167|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489168|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489169|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489170|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489171|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489172|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489173|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489174|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489175|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489176|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489177|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489178|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489179|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489180|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489181|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489182|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489183|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489184|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489185|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489186|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489187|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489188|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489189|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489190|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489191|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489192|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489193|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489194|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489195|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489196|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489197|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489198|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489199|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489200|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489201|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489202|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489203|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489204|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489205|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489206|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489207|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489208|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489209|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489210|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489211|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489212|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489213|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489214|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489215|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489216|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489217|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489218|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489219|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489220|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489221|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489222|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489223|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489224|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489225|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489226|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489227|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489228|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489229|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489230|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489231|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489232|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489233|NCT00711009|E2|Reported Event|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
489234|NCT00711009|E1|Reported Event|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
489235|NCT00711022|B1|Baseline|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
489236|NCT00711022|P1|Participant Flow|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
489237|NCT00711022|O1|Outcome|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
489238|NCT00711022|E1|Reported Event|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
489239|NCT00711958|B3|Baseline|Total|Total of all reporting groups
489240|NCT00711958|B2|Baseline|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.
ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
489241|NCT00711958|B1|Baseline|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.
HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
489242|NCT00711958|P2|Participant Flow|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.
ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
489243|NCT00711958|P1|Participant Flow|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.
HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
489244|NCT00711958|O2|Outcome|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.
ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
489245|NCT00711958|O1|Outcome|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.
HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
489246|NCT00711958|E2|Reported Event|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.
ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
489294|NCT00711997|O2|Outcome|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
492187|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
489247|NCT00711958|E1|Reported Event|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.
HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
489248|NCT00711971|B4|Baseline|Total|Total of all reporting groups
489249|NCT00711971|B3|Baseline|Soy Oil Placebo|placebo: control arm
489250|NCT00711971|B2|Baseline|DHA-rich Fish Oil Supplement|"DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA"
489251|NCT00711971|B1|Baseline|EPA-rich Fish Oil Supplement|"EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA"
489252|NCT00711971|P3|Participant Flow|Soy Oil Placebo|Soy oil placebo: control arm
489253|NCT00711971|P2|Participant Flow|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
489254|NCT00711971|P1|Participant Flow|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
489255|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
489256|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
489257|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
489258|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
489259|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
489260|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
489261|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
489262|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
489263|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
489264|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
489265|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
489266|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
489267|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
489268|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
489269|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
489270|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
489271|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
489272|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
489273|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
489274|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
489275|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
489276|NCT00711971|O3|Outcome|Soy Oil Placebo|"Soy oil
placebo: control arm"
489277|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|"DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA"
489278|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|"EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA"
489279|NCT00711971|O3|Outcome|Soy Oil Placebo|placebo: control arm
489280|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|"DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA"
489281|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|"EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA"
489282|NCT00711971|E3|Reported Event|Soy Oil Placebo|Soy oil placebo: control arm
489283|NCT00711971|E2|Reported Event|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
489284|NCT00711971|E1|Reported Event|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
489285|NCT00711997|B3|Baseline|Total|Total of all reporting groups
489286|NCT00711997|B2|Baseline|BC-819 8 mg|
489287|NCT00711997|B1|Baseline|BC-819 4 mg|
489288|NCT00711997|P2|Participant Flow|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
489289|NCT00711997|P1|Participant Flow|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
489290|NCT00711997|O2|Outcome|BC-819 8 mg|2 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819. Intratumoral injections were performed using CT-guided PTA or EUS of BC-819.
489291|NCT00711997|O1|Outcome|BC-819 4 mg|1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819. Intratumoral injections were performed using CT-guided PTA or EUS of BC-819.
489292|NCT00711997|O2|Outcome|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
489293|NCT00711997|O1|Outcome|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
489573|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
489295|NCT00711997|O1|Outcome|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
489296|NCT00711997|E2|Reported Event|BC-819 8 mg|2 mL of 4 mg/mL for a total of 8 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
489297|NCT00711997|E1|Reported Event|BC-819 4 mg|1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
489298|NCT00712010|B1|Baseline|Entire Study Population|Includes groups randomized to receive 7 products in a randomized series
489299|NCT00712010|P1|Participant Flow|7 Proteins Were Tested Randomly|"Seven high-protein meal replacement (MR) were tested. These high-protein MR contained 29% total energy intake (TEI) of protein, 28% TEI lipids and 43% TEI glucides in 400mL meal, were iso-nitrogenous and differed in their protein quality. The proteins were:
intact whey protein
whey protein micelles
exhaustively hydrolyzed whey protein
intact casein protein
exhaustively hydrolyzed casein protein
total milk protein
exhaustively hydrolyzed milk protein The high-protein MR were a 430g liquid meal containing 30g of the tested protein."
489300|NCT00712010|O7|Outcome|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489301|NCT00712010|O6|Outcome|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489302|NCT00712010|O5|Outcome|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489303|NCT00712010|O4|Outcome|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489304|NCT00712010|O3|Outcome|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489305|NCT00712010|O2|Outcome|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489306|NCT00712010|O1|Outcome|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489307|NCT00712010|O7|Outcome|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489308|NCT00712010|O6|Outcome|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489309|NCT00712010|O5|Outcome|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489310|NCT00712010|O4|Outcome|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489311|NCT00712010|O3|Outcome|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489312|NCT00712010|O2|Outcome|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489313|NCT00712010|O1|Outcome|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489314|NCT00712010|E7|Reported Event|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489315|NCT00712010|E6|Reported Event|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489316|NCT00712010|E5|Reported Event|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489317|NCT00712010|E4|Reported Event|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489318|NCT00712010|E3|Reported Event|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489319|NCT00712010|E2|Reported Event|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489320|NCT00712010|E1|Reported Event|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
489321|NCT00712075|B4|Baseline|Total|Total of all reporting groups
489322|NCT00712075|B3|Baseline|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
489323|NCT00712075|B2|Baseline|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
489324|NCT00712075|B1|Baseline|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
492188|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
489325|NCT00712075|P3|Participant Flow|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
489326|NCT00712075|P2|Participant Flow|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
489327|NCT00712075|P1|Participant Flow|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
489328|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
489329|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
489330|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
489331|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
489349|NCT00712166|O2|Outcome|AZLI 75 mg TID|"AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
Day 0: number of isolates = 104; Day 28: number of isolates = 76"
489388|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489332|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
489333|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
489334|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
489335|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
489358|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489574|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489336|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
489337|NCT00712075|E3|Reported Event|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
489338|NCT00712075|E2|Reported Event|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
489339|NCT00712075|E1|Reported Event|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
489340|NCT00712166|B3|Baseline|Total|Total of all reporting groups
489341|NCT00712166|B2|Baseline|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489342|NCT00712166|B1|Baseline|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489343|NCT00712166|P2|Participant Flow|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489344|NCT00712166|P1|Participant Flow|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489345|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489346|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489347|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489348|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489350|NCT00712166|O1|Outcome|Placebo TID|"Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
Day 0: number of isolates = 104; Day 28: number of isolates = 108"
489351|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489352|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489353|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489354|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489355|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489356|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489357|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489416|NCT00712244|E4|Reported Event|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489359|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489360|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489361|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489362|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489363|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489364|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489365|NCT00712166|E2|Reported Event|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
489366|NCT00712166|E1|Reported Event|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
489367|NCT00712179|B1|Baseline|Stroke Survivors|Cross-sectional study with a single group of stroke survivors
489368|NCT00712179|P1|Participant Flow|Stroke Survivors|Stroke survivors walked with varying speeds, amount of body weight support or therapist assistance
489369|NCT00712179|O1|Outcome|Stroke Survivors|Stroke survivors walked with varying speeds, amount of body weight support or therapist assistance
489370|NCT00712179|E1|Reported Event|Stroke Survivors|Subjects walked with or with therapists' assistance at different speeds and different amounts of body weight support across conditions.
489371|NCT00712244|B5|Baseline|Total|Total of all reporting groups
489372|NCT00712244|B4|Baseline|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489373|NCT00712244|B3|Baseline|Healon5|Healon5 Ophthalmic Viscosurgical Device
489374|NCT00712244|B2|Baseline|DUOVISC|DUOVISC® Viscoelastic system
489375|NCT00712244|B1|Baseline|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
489376|NCT00712244|P4|Participant Flow|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489377|NCT00712244|P3|Participant Flow|Healon5|Healon5 Ophthalmic Viscosurgical Device
489378|NCT00712244|P2|Participant Flow|DUOVISC|DUOVISC® Viscoelastic system
489379|NCT00712244|P1|Participant Flow|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
489380|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489381|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
489382|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
489383|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
489384|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489385|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
489386|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
489387|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
489389|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
489390|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
489391|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
489392|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489393|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
489394|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
489395|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
489396|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489397|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
489398|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
489399|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
489400|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489401|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
489402|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
489403|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
489404|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489405|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
489406|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
489407|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
489408|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489409|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
489410|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
489411|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
489412|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
489413|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
489414|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
489415|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
489422|NCT00712335|B4|Baseline|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489423|NCT00712335|B3|Baseline|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489424|NCT00712335|B2|Baseline|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489425|NCT00712335|B1|Baseline|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489426|NCT00712335|P5|Participant Flow|Normal Controls|Normal controls did not receive any treatment.
489427|NCT00712335|P4|Participant Flow|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489428|NCT00712335|P3|Participant Flow|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489429|NCT00712335|P2|Participant Flow|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489430|NCT00712335|P1|Participant Flow|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489431|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
489432|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489433|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489434|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489435|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489436|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
489437|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489438|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489439|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489440|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489441|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
489442|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489443|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489444|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489445|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489446|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
489447|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489448|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489449|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489450|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489451|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
489452|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489453|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489454|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489455|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489456|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
489457|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489575|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489458|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489459|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489460|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489461|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
489462|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489463|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489464|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489465|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489466|NCT00712335|E5|Reported Event|Normal Controls|Normal controls did not receive any treatment.
489467|NCT00712335|E4|Reported Event|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489468|NCT00712335|E3|Reported Event|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489469|NCT00712335|E2|Reported Event|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:
Montelukast dosage - PO 10 mg QHS for 3 months"
489470|NCT00712335|E1|Reported Event|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
489471|NCT00712348|B1|Baseline|Taliglucerase Alfa|"Open label taliglucerase alfa treatment
Taliglucerase alfa: Intravenous infusion every 2 weeks"
489472|NCT00712348|P1|Participant Flow|Taliglucerase Alfa|"Open label taliglucerase alfa treatment
Taliglucerase alfa: Intravenous infusion every 2 weeks"
489473|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment
Taliglucerase alfa: Intravenous infusion every 2 weeks"
489474|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment
Taliglucerase alfa: Intravenous infusion every 2 weeks"
489475|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment
Taliglucerase alfa: Intravenous infusion every 2 weeks"
489476|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment
Taliglucerase alfa: Intravenous infusion every 2 weeks"
489477|NCT00712348|E1|Reported Event|Taliglucerase Alfa|"Open label taliglucerase alfa treatment
Taliglucerase alfa: Intravenous infusion every 2 weeks"
489478|NCT00712530|B4|Baseline|Total|Total of all reporting groups
489479|NCT00712530|B3|Baseline|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization
0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
489480|NCT00712530|B2|Baseline|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization
0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
489481|NCT00712530|B1|Baseline|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization
0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
489482|NCT00712530|P3|Participant Flow|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization
0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
489483|NCT00712530|P2|Participant Flow|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization
0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
489484|NCT00712530|P1|Participant Flow|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization
0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
489485|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization
0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
489486|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization
0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
489487|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization
0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
489488|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization
0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
489489|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization
0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
489490|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization
0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
489576|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
489491|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization
0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
489492|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization
0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
489493|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization
0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
489494|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization
0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
489495|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization
0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
489496|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization
0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
489497|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization
0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
489498|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization
0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
489499|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization
0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
489500|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization
0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
489501|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization
0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
489502|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization
0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
489503|NCT00712530|E3|Reported Event|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization
0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
489504|NCT00712530|E2|Reported Event|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization
0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
489505|NCT00712530|E1|Reported Event|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization
0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
489506|NCT00712543|B3|Baseline|Total|Total of all reporting groups
489507|NCT00712543|B2|Baseline|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
489730|NCT00713310|B3|Baseline|Total|Total of all reporting groups
489508|NCT00712543|B1|Baseline|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
489509|NCT00712543|P2|Participant Flow|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
489510|NCT00712543|P1|Participant Flow|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
489511|NCT00712543|O2|Outcome|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
489512|NCT00712543|O1|Outcome|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
489513|NCT00712543|E2|Reported Event|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
489514|NCT00712543|E1|Reported Event|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
489515|NCT00712673|B4|Baseline|Total|Total of all reporting groups
489516|NCT00712673|B3|Baseline|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
489517|NCT00712673|B2|Baseline|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
489518|NCT00712673|B1|Baseline|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
489519|NCT00712673|P4|Participant Flow|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
489520|NCT00712673|P3|Participant Flow|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
489521|NCT00712673|P2|Participant Flow|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
492189|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
489522|NCT00712673|P1|Participant Flow|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
489523|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489524|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489525|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
489526|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489527|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489528|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
489529|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489530|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489531|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
489532|NCT00712673|O6|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of lixisenatide.
489533|NCT00712673|O5|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489534|NCT00712673|O4|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489535|NCT00712673|O3|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of volume matching placebo.
489536|NCT00712673|O2|Outcome|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo.
489537|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo.
489538|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489539|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489540|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of volume matching placebo.
489541|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489542|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489543|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
489544|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489545|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489546|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
489547|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489548|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
489549|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489550|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
489551|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489552|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
489553|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489554|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
489555|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489556|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
489557|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489558|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
489559|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489560|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
489561|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489562|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
489563|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489564|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489565|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
489566|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489567|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489568|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
489569|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489570|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
489571|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489572|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
490380|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
489577|NCT00712673|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation morning and evening regimen of lixisenatide.
489578|NCT00712673|E5|Reported Event|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
489579|NCT00712673|E4|Reported Event|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
489580|NCT00712673|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
489581|NCT00712673|E2|Reported Event|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo.
489582|NCT00712673|E1|Reported Event|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo.
489583|NCT00712725|B9|Baseline|Total|Total of all reporting groups
489584|NCT00712725|B8|Baseline|MK3207 200 mg|"MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
489585|NCT00712725|B7|Baseline|MK3207 100 mg|"MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
489586|NCT00712725|B6|Baseline|MK3207 50 mg|"MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
489587|NCT00712725|B5|Baseline|MK3207 20 mg|"MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
489588|NCT00712725|B4|Baseline|MK3207 10 mg|"MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
489589|NCT00712725|B3|Baseline|MK3207 5 mg|"MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
489590|NCT00712725|B2|Baseline|MK3207 2.5 mg|"MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
489591|NCT00712725|B1|Baseline|Placebo|"Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
489592|NCT00712725|P8|Participant Flow|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489593|NCT00712725|P7|Participant Flow|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489594|NCT00712725|P6|Participant Flow|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489595|NCT00712725|P5|Participant Flow|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489596|NCT00712725|P4|Participant Flow|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489804|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
489597|NCT00712725|P3|Participant Flow|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489598|NCT00712725|P2|Participant Flow|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489599|NCT00712725|P1|Participant Flow|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
489600|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489601|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489602|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489603|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489604|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489605|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489606|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489607|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
489608|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489609|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489610|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489611|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489612|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489613|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489614|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489615|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
489616|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489617|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
498399|NCT00732199|O1|Outcome|Healthy Older Adults|Older adults
489618|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489619|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489620|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489621|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489622|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489623|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
489624|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489625|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489626|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489627|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489628|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489629|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489630|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489631|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
489632|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489633|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489634|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489635|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489636|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489637|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489638|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489639|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
489640|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489641|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489642|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489643|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
498771|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
489644|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489645|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489646|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489647|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
489648|NCT00712725|E8|Reported Event|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489649|NCT00712725|E7|Reported Event|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489650|NCT00712725|E6|Reported Event|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489651|NCT00712725|E5|Reported Event|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489652|NCT00712725|E4|Reported Event|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489653|NCT00712725|E3|Reported Event|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489654|NCT00712725|E2|Reported Event|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
489655|NCT00712725|E1|Reported Event|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
489656|NCT00712920|B4|Baseline|Total|Total of all reporting groups
489657|NCT00712920|B3|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489658|NCT00712920|B2|Baseline|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489659|NCT00712920|B1|Baseline|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489660|NCT00712920|P3|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489661|NCT00712920|P2|Participant Flow|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489662|NCT00712920|P1|Participant Flow|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489663|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489664|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489665|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489666|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489667|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489668|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489669|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489670|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489671|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489672|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489673|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489674|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489675|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489676|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489677|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489678|NCT00712920|E3|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489679|NCT00712920|E2|Reported Event|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489680|NCT00712920|E1|Reported Event|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
489681|NCT00712959|B3|Baseline|Total|Total of all reporting groups
489682|NCT00712959|B2|Baseline|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
489683|NCT00712959|B1|Baseline|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
489684|NCT00712959|P2|Participant Flow|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
489685|NCT00712959|P1|Participant Flow|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
489686|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
489687|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
489688|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
489689|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
489731|NCT00713310|B2|Baseline|High-Dose|17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
489690|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
489691|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
489692|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
489693|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
489694|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
489695|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
489696|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
489697|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
489698|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
489699|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
489700|NCT00712959|E2|Reported Event|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
489701|NCT00712959|E1|Reported Event|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
489702|NCT00712985|B1|Baseline|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
489703|NCT00712985|P1|Participant Flow|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
489704|NCT00712985|O1|Outcome|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
489921|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
489705|NCT00712985|E1|Reported Event|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
489706|NCT00713206|B3|Baseline|Total|Total of all reporting groups
489707|NCT00713206|B2|Baseline|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
489708|NCT00713206|B1|Baseline|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
489709|NCT00713206|P2|Participant Flow|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
489710|NCT00713206|P1|Participant Flow|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
489711|NCT00713206|O2|Outcome|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
489712|NCT00713206|O1|Outcome|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
489713|NCT00713206|E2|Reported Event|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
489714|NCT00713206|E1|Reported Event|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
489715|NCT00713219|B1|Baseline|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
489716|NCT00713219|P1|Participant Flow|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
489717|NCT00713219|O1|Outcome|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
489718|NCT00713219|E1|Reported Event|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
489719|NCT00713258|B3|Baseline|Total|Total of all reporting groups
489720|NCT00713258|B2|Baseline|Alendronate|"PTH (1-84) placebo + alendronate
PTH (1-84) placebo: powder and solvent for solution for injection
alendronate: capsule"
489721|NCT00713258|B1|Baseline|PTH (1-84)|"PTH (1-84) + placebo alendronate
PTH (1-84): powder and solvent for solution for injection
placebo alendronate: capsule"
489722|NCT00713258|P2|Participant Flow|Alendronate|"PTH (1-84) placebo + alendronate
PTH (1-84) placebo: powder and solvent for solution for injection
alendronate: capsule"
489723|NCT00713258|P1|Participant Flow|PTH (1-84)|"PTH (1-84) + placebo alendronate
PTH (1-84): powder and solvent for solution for injection
placebo alendronate: capsule"
489724|NCT00713258|O2|Outcome|Alendronate|"PTH (1-84) placebo + alendronate
PTH (1-84) placebo: powder and solvent for solution for injection
alendronate: capsule"
489725|NCT00713258|O1|Outcome|PTH (1-84)|"PTH (1-84) + placebo alendronate
PTH (1-84): powder and solvent for solution for injection
placebo alendronate: capsule"
489726|NCT00713258|O2|Outcome|Alendronate|"PTH (1-84) placebo + alendronate
PTH (1-84) placebo: powder and solvent for solution for injection
alendronate: capsule"
489727|NCT00713258|O1|Outcome|PTH (1-84)|"PTH (1-84) + placebo alendronate
PTH (1-84): powder and solvent for solution for injection
placebo alendronate: capsule"
489728|NCT00713258|E2|Reported Event|Alendronate|"PTH (1-84) placebo + alendronate
PTH (1-84) placebo: powder and solvent for solution for injection
alendronate: capsule"
489729|NCT00713258|E1|Reported Event|PTH (1-84)|"PTH (1-84) + placebo alendronate
PTH (1-84): powder and solvent for solution for injection
placebo alendronate: capsule"
489732|NCT00713310|B1|Baseline|Low-Dose|17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
489733|NCT00713310|P2|Participant Flow|High-Dose|17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
489734|NCT00713310|P1|Participant Flow|Low-Dose|17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
489735|NCT00713310|O2|Outcome|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
489736|NCT00713310|O1|Outcome|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
489737|NCT00713310|O2|Outcome|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
489738|NCT00713310|O1|Outcome|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
489739|NCT00713310|E2|Reported Event|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
489740|NCT00713310|E1|Reported Event|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
489741|NCT00713323|B1|Baseline|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
489742|NCT00713323|P1|Participant Flow|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
489743|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
489744|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
489745|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
489746|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
489747|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
489748|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
489749|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
489750|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
489751|NCT00713323|E1|Reported Event|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
489752|NCT00713349|B1|Baseline|Vehicle vs. Placebo|"Xenaderm Vehicle and White Petrolatum as Placebo Comparator
Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.
White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days
Each subject acting as their own control"
489753|NCT00713349|P1|Participant Flow|Vehicle vs. Placebo|"Xenaderm Vehicle and White Petrolatum as Placebo Comparator
Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.
White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days
Each subject acting as their own control"
489754|NCT00713349|O2|Outcome|Placebo Control|White Petrolatum : each subject acting as their own control
489755|NCT00713349|O1|Outcome|Vehicle|Xenaderm Ointment Vehicle : each subject acting as their own control
489756|NCT00713349|E2|Reported Event|Placebo Control|White Petrolatum : each subject acting as their own control
489757|NCT00713349|E1|Reported Event|Vehicle|Xenaderm Ointment Vehicle : each subject acting as their own control
489758|NCT00713479|B1|Baseline|Total Sample|Includes only subjects who completed both components of the trial.
489759|NCT00713479|P2|Participant Flow|Varenicline, Then Placebo|Varenicline dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the placebo condition is started. Placebo is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
489760|NCT00713479|P1|Participant Flow|Placebo, Then Varenicline|Placebo drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the varenicline condition is started. Varenicline is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
489761|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
489762|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
489803|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
489763|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
489764|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
489765|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
489766|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
489767|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)"
489768|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
489769|NCT00713479|E2|Reported Event|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)"
489770|NCT00713479|E1|Reported Event|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.
Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
489771|NCT00713544|B7|Baseline|Total|Total of all reporting groups
489772|NCT00713544|B6|Baseline|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
489773|NCT00713544|B5|Baseline|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
489774|NCT00713544|B4|Baseline|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
489775|NCT00713544|B3|Baseline|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
489776|NCT00713544|B2|Baseline|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
489777|NCT00713544|B1|Baseline|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
489778|NCT00713544|P6|Participant Flow|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
489779|NCT00713544|P5|Participant Flow|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
489780|NCT00713544|P4|Participant Flow|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
489781|NCT00713544|P3|Participant Flow|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
489782|NCT00713544|P2|Participant Flow|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
489783|NCT00713544|P1|Participant Flow|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
489784|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
489785|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
489786|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
489787|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
489788|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
489789|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
489790|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
489791|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
489792|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
489793|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
489794|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
489795|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
489796|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
489797|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
489798|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
489799|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
489800|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
489801|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
489802|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
498772|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
489805|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
489806|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
489807|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
489808|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
489809|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
489810|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
489811|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
489812|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
489813|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
489814|NCT00713544|E6|Reported Event|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
489815|NCT00713544|E5|Reported Event|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
489816|NCT00713544|E4|Reported Event|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
489817|NCT00713544|E3|Reported Event|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
489818|NCT00713544|E2|Reported Event|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
489819|NCT00713544|E1|Reported Event|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
489820|NCT00713596|B4|Baseline|Total|Total of all reporting groups
489821|NCT00713596|B3|Baseline|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
489822|NCT00713596|B2|Baseline|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
489823|NCT00713596|B1|Baseline|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
489923|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
489824|NCT00713596|P3|Participant Flow|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
489825|NCT00713596|P2|Participant Flow|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
489826|NCT00713596|P1|Participant Flow|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
489827|NCT00713596|O3|Outcome|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
489828|NCT00713596|O2|Outcome|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
489829|NCT00713596|O1|Outcome|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
489830|NCT00713596|O3|Outcome|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
489831|NCT00713596|O2|Outcome|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
489832|NCT00713596|O1|Outcome|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
489833|NCT00713596|E3|Reported Event|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
489834|NCT00713596|E2|Reported Event|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
489835|NCT00713596|E1|Reported Event|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
489836|NCT00713609|B7|Baseline|Total|Total of all reporting groups
489854|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489837|NCT00713609|B6|Baseline|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489838|NCT00713609|B5|Baseline|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489839|NCT00713609|B4|Baseline|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489840|NCT00713609|B3|Baseline|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489841|NCT00713609|B2|Baseline|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489842|NCT00713609|B1|Baseline|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face
489922|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
489843|NCT00713609|P6|Participant Flow|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489844|NCT00713609|P5|Participant Flow|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489845|NCT00713609|P4|Participant Flow|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489846|NCT00713609|P3|Participant Flow|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489847|NCT00713609|P2|Participant Flow|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489848|NCT00713609|P1|Participant Flow|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face
489849|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489850|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489851|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489852|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489853|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489902|NCT00713661|O1|Outcome|Group 1: Open Surgery Lower|
489855|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489856|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489857|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489858|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489859|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489860|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489861|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489862|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489863|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489864|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489865|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489866|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489867|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489868|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489869|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489870|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489871|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489903|NCT00713661|E4|Reported Event|Group 4: Laparoscopic Surgery Middle/Upper|
489872|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489873|NCT00713609|E6|Reported Event|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489874|NCT00713609|E5|Reported Event|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489875|NCT00713609|E4|Reported Event|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489876|NCT00713609|E3|Reported Event|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489877|NCT00713609|E2|Reported Event|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489878|NCT00713609|E1|Reported Event|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
489879|NCT00713648|B1|Baseline|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
489880|NCT00713648|P1|Participant Flow|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
489881|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
489882|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
489883|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
489884|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
489885|NCT00713648|E1|Reported Event|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
489886|NCT00713661|B5|Baseline|Total|Total of all reporting groups
489887|NCT00713661|B4|Baseline|Group 4: Laparoscopic Surgery Middle/Upper|
489888|NCT00713661|B3|Baseline|Group 3: Laparoscopic Surgery Lower|
489889|NCT00713661|B2|Baseline|Group 2: Open Surgery Middle/Upper|
489890|NCT00713661|B1|Baseline|Group 1: Open Surgery Lower|
489891|NCT00713661|P4|Participant Flow|Group 4: Laparoscopic Surgery Middle/Upper|Laparasocopic colorectal resection. The anastomotic line in the mid/upper segment 5-12 cm from the anal verge.
489892|NCT00713661|P3|Participant Flow|Group 3: Laparoscopic Surgery Lower|Laparoscopic colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.
489893|NCT00713661|P2|Participant Flow|Group 2: Open Surgery Middle/Upper|Open colorectal resection. The anastomotic line in the middle/upper segment 5-12 cm from the anal verge.
489894|NCT00713661|P1|Participant Flow|Group 1: Open Surgery Lower|Open colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.
489895|NCT00713661|O4|Outcome|Group 4: Laparoscopic Surgery Middle/Upper|
489896|NCT00713661|O3|Outcome|Group 3: Laparoscopic Surgery Lower|
489897|NCT00713661|O2|Outcome|Group 2: Open Surgery Middle/Upper|
489898|NCT00713661|O1|Outcome|Group 1: Open Surgery Lower|
489899|NCT00713661|O4|Outcome|Group 4: Laparoscopic Surgery Middle/Upper|
489900|NCT00713661|O3|Outcome|Group 3: Laparoscopic Surgery Lower|
489901|NCT00713661|O2|Outcome|Group 2: Open Surgery Middle/Upper|
489907|NCT00713700|B1|Baseline|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
489908|NCT00713700|P1|Participant Flow|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
489909|NCT00713700|O1|Outcome|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
489910|NCT00713700|O1|Outcome|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
489911|NCT00713700|E1|Reported Event|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
489912|NCT00713817|B3|Baseline|Total|Total of all reporting groups
489913|NCT00713817|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
489914|NCT00713817|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
489915|NCT00713817|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
489916|NCT00713817|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
489917|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
489918|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
489919|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
489920|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
490381|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
489924|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
489925|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
489926|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
489927|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
489928|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
489929|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
489930|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
489931|NCT00713817|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
489932|NCT00713817|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
489933|NCT00713830|B3|Baseline|Total|Total of all reporting groups
489934|NCT00713830|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
489935|NCT00713830|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
489936|NCT00713830|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
489937|NCT00713830|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
489938|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489939|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489940|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489941|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489942|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489943|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489944|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489945|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489946|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489947|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489948|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489949|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489950|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489951|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489952|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489953|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489954|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489955|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489956|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489957|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489958|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489959|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489960|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489961|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489962|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489963|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489964|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489965|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489966|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489967|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489968|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
489969|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
489970|NCT00713830|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
489971|NCT00713830|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
489972|NCT00714051|B3|Baseline|Total|Total of all reporting groups
489973|NCT00714051|B2|Baseline|Control Group|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
490054|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490382|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
489974|NCT00714051|B1|Baseline|Falls Prevention Training Group|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
489975|NCT00714051|P2|Participant Flow|Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
489976|NCT00714051|P1|Participant Flow|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
489977|NCT00714051|O2|Outcome|Attention Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
489978|NCT00714051|O1|Outcome|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
489979|NCT00714051|E2|Reported Event|Attention Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
489980|NCT00714051|E1|Reported Event|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
489981|NCT00714168|B3|Baseline|Total|Total of all reporting groups
489982|NCT00714168|B2|Baseline|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
489983|NCT00714168|B1|Baseline|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
489984|NCT00714168|P2|Participant Flow|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
489985|NCT00714168|P1|Participant Flow|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
489986|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
489987|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
489988|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
489989|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
489990|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
489991|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
490032|NCT00714259|B1|Baseline|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section
Fludarabine: Fludarabine 30 mg/m2/day x 3 days
Total Body Irradiation: TBI 200cGy x1 dose on transplant day
Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
492190|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
489992|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
489993|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
489994|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
489995|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
489996|NCT00714168|E2|Reported Event|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
489997|NCT00714168|E1|Reported Event|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
489998|NCT00714233|B5|Baseline|Total|Total of all reporting groups
489999|NCT00714233|B4|Baseline|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
490000|NCT00714233|B3|Baseline|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
490001|NCT00714233|B2|Baseline|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
490002|NCT00714233|B1|Baseline|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
490003|NCT00714233|P4|Participant Flow|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
490004|NCT00714233|P3|Participant Flow|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
490005|NCT00714233|P2|Participant Flow|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
490006|NCT00714233|P1|Participant Flow|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
490007|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
490008|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
490009|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
490010|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
490011|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
490012|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
490013|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
490014|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
490015|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
498773|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
490016|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
490017|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
490018|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
490019|NCT00714233|O4|Outcome|Placebo to Metformin|Matched to metformin pill
490020|NCT00714233|O3|Outcome|Lifestle|Those assigned to a nutrition and exercise program
490021|NCT00714233|O2|Outcome|Oral Contraceptive|group assigned to oral contraceptive for 24 weeks
490022|NCT00714233|O1|Outcome|Metformin|Group assigned to metformin with free androgen index measured
490023|NCT00714233|O1|Outcome|Lifestyle Program|Subjects enrolled in a nutrition and exercise program
490024|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
490025|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
490026|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
490027|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
490028|NCT00714233|E4|Reported Event|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
490029|NCT00714233|E3|Reported Event|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
490030|NCT00714233|E2|Reported Event|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
490031|NCT00714233|E1|Reported Event|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
490033|NCT00714259|P1|Participant Flow|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section
Fludarabine: Fludarabine 30 mg/m2/day x 3 days
Total Body Irradiation: TBI 200cGy x1 dose on transplant day
Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
490034|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section
Fludarabine: Fludarabine 30 mg/m2/day x 3 days
Total Body Irradiation: TBI 200cGy x1 dose on transplant day
Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
490035|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section
Fludarabine: Fludarabine 30 mg/m2/day x 3 days
Total Body Irradiation: TBI 200cGy x1 dose on transplant day
Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
490036|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section
Fludarabine: Fludarabine 30 mg/m2/day x 3 days
Total Body Irradiation: TBI 200cGy x1 dose on transplant day
Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
490037|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section
Fludarabine: Fludarabine 30 mg/m2/day x 3 days
Total Body Irradiation: TBI 200cGy x1 dose on transplant day
Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
490038|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section
Fludarabine: Fludarabine 30 mg/m2/day x 3 days
Total Body Irradiation: TBI 200cGy x1 dose on transplant day
Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
490039|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section
Fludarabine: Fludarabine 30 mg/m2/day x 3 days
Total Body Irradiation: TBI 200cGy x1 dose on transplant day
Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
490040|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section
Fludarabine: Fludarabine 30 mg/m2/day x 3 days
Total Body Irradiation: TBI 200cGy x1 dose on transplant day
Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
490041|NCT00714259|E1|Reported Event|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section
Fludarabine: Fludarabine 30 mg/m2/day x 3 days
Total Body Irradiation: TBI 200cGy x1 dose on transplant day
Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
490042|NCT00714285|B5|Baseline|Total|Total of all reporting groups
490043|NCT00714285|B4|Baseline|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490044|NCT00714285|B3|Baseline|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490072|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490045|NCT00714285|B2|Baseline|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490046|NCT00714285|B1|Baseline|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490047|NCT00714285|P4|Participant Flow|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490048|NCT00714285|P3|Participant Flow|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490049|NCT00714285|P2|Participant Flow|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490050|NCT00714285|P1|Participant Flow|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490051|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490052|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490053|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
498842|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
490055|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490056|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490057|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490058|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490059|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490060|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490061|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490062|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490063|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490064|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490065|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490066|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490067|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490068|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490069|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490070|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490071|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
491167|NCT00706901|E1|Reported Event|Arm 1 GMI|Group Motivational Interviewing
490073|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490074|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490075|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490076|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490077|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490078|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490079|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490080|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490081|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490082|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490083|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490084|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490085|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490086|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490087|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490088|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490089|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490090|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490091|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490092|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
490093|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490094|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490095|NCT00714285|E4|Reported Event|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490096|NCT00714285|E3|Reported Event|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490097|NCT00714285|E2|Reported Event|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490098|NCT00714285|E1|Reported Event|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
490099|NCT00714311|B3|Baseline|Total|Total of all reporting groups
490100|NCT00714311|B2|Baseline|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
490101|NCT00714311|B1|Baseline|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
490102|NCT00714311|P2|Participant Flow|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
490103|NCT00714311|P1|Participant Flow|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
490104|NCT00714311|O2|Outcome|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
490105|NCT00714311|O1|Outcome|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
490106|NCT00714311|E2|Reported Event|Treatment by Experienced Community Psychotherapists|"treatment by experienced community psychotherapists (ECP)
treatment by experienced community psychotherapists: Outpatient psychotherapy in private practices or outpatient units of psychiatric hospitals. Licensed psychotherapists with experience and special interest in the treatment of borderline patients are treating according to the method they have learned."
490107|NCT00714311|E1|Reported Event|Transference-Focused Psychotherapy|"Transference-Focused Psychotherapy (TFP)
Transference-Focused Psychotherapy: Outpatient psychotherapy according to the treatment manual, sessions of 50 minutes twice per week"
490108|NCT00714389|B1|Baseline|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
490109|NCT00714389|P1|Participant Flow|Spontaneous Uroflow Measurements|Spontaneous voids of volunteers working in the care facility will recorded by uroflowmetry.
490110|NCT00714389|O1|Outcome|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
490111|NCT00714389|O1|Outcome|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
490112|NCT00714389|E1|Reported Event|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
490113|NCT00705679|B6|Baseline|Total|Total of all reporting groups
490114|NCT00705679|B5|Baseline|Gel Placebo|"Application of tenofovir placebo gel once daily
Tenofovir placebo: placebo gel"
490115|NCT00705679|B4|Baseline|TFV Gel|"Application of tenofovir 1% vaginal gel once daily
Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
490116|NCT00705679|B3|Baseline|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet
Tenofovir disoproxil fumarate placebo: placebo tablet"
492191|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
490117|NCT00705679|B2|Baseline|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet
Tenofovir disoproxil fumarate placebo: placebo tablet"
490118|NCT00705679|B1|Baseline|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet
Tenofovir disoproxil fumarate: 300 mg tablet"
490119|NCT00705679|P5|Participant Flow|Gel Placebo|"Application of tenofovir placebo gel once daily
Tenofovir placebo: placebo gel"
490120|NCT00705679|P4|Participant Flow|TFV Gel|"Application of tenofovir 1% vaginal gel once daily
Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
490121|NCT00705679|P3|Participant Flow|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet
Tenofovir disoproxil fumarate placebo: placebo tablet"
490122|NCT00705679|P2|Participant Flow|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet
Tenofovir disoproxil fumarate placebo: placebo tablet"
490123|NCT00705679|P1|Participant Flow|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet
Tenofovir disoproxil fumarate: 300 mg tablet"
490124|NCT00705679|O5|Outcome|Gel Placebo|"Application of tenofovir placebo gel once daily
Tenofovir placebo: placebo gel"
490125|NCT00705679|O4|Outcome|TFV Gel|"Application of tenofovir 1% vaginal gel once daily
Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
490126|NCT00705679|O3|Outcome|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet
Tenofovir disoproxil fumarate placebo: placebo tablet"
490127|NCT00705679|O2|Outcome|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet
Tenofovir disoproxil fumarate placebo: placebo tablet"
490128|NCT00705679|O1|Outcome|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet
Tenofovir disoproxil fumarate: 300 mg tablet"
490129|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
490130|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
490131|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
490132|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
490133|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
490134|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
490177|NCT00705757|B3|Baseline|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
490135|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
490136|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
490137|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
490138|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
490139|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
490140|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
490141|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
490142|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
490143|NCT00705679|O5|Outcome|Gel Placebo|"Application of tenofovir placebo gel once daily
Tenofovir placebo: placebo gel"
490144|NCT00705679|O4|Outcome|TFV Gel|"Application of tenofovir 1% vaginal gel once daily
Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
490145|NCT00705679|O3|Outcome|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet
Tenofovir disoproxil fumarate placebo: placebo tablet"
502689|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
490146|NCT00705679|O2|Outcome|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet
Tenofovir disoproxil fumarate placebo: placebo tablet"
490147|NCT00705679|O1|Outcome|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet
Tenofovir disoproxil fumarate: 300 mg tablet"
490148|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
490149|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
490150|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
490151|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
490152|NCT00705679|E5|Reported Event|Gel Placebo|"Application of tenofovir placebo gel once daily
Tenofovir placebo: placebo gel"
490153|NCT00705679|E4|Reported Event|TFV Gel|"Application of tenofovir 1% vaginal gel once daily
Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
490154|NCT00705679|E3|Reported Event|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet
Tenofovir disoproxil fumarate placebo: placebo tablet"
490155|NCT00705679|E2|Reported Event|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet
Tenofovir disoproxil fumarate placebo: placebo tablet"
490156|NCT00705679|E1|Reported Event|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet
Tenofovir disoproxil fumarate: 300 mg tablet"
490157|NCT00705718|B3|Baseline|Total|Total of all reporting groups
490158|NCT00705718|B2|Baseline|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
490159|NCT00705718|B1|Baseline|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
490160|NCT00705718|P2|Participant Flow|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
490161|NCT00705718|P1|Participant Flow|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
490162|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
490163|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
490164|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
490165|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
490166|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
490167|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
490168|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
490169|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
490170|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
490171|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
490172|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
490173|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
490174|NCT00705718|E2|Reported Event|2. Endurant Bifurcated Arm|Endurant Stent Graft System - Endurant Bifurcated arm
490175|NCT00705718|E1|Reported Event|1. Endurant AUI Arm|Endurant Stent Graft System - Endurant AUI arm
490176|NCT00705757|B4|Baseline|Total|Total of all reporting groups
490178|NCT00705757|B2|Baseline|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
490179|NCT00705757|B1|Baseline|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
490180|NCT00705757|P3|Participant Flow|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
490181|NCT00705757|P2|Participant Flow|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
490182|NCT00705757|P1|Participant Flow|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
490183|NCT00705757|O3|Outcome|Travatan|Participants were assigned to use Travatan ophthalmic solution one drop qhs for one year in affected eye(s).
490184|NCT00705757|O2|Outcome|Xalatan|Participants were assigned to use Xalatan ophthalmic solution one drop qhs for one year in affected eye(s).
490185|NCT00705757|O1|Outcome|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s).
490186|NCT00705757|E3|Reported Event|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
490187|NCT00705757|E2|Reported Event|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
490188|NCT00705757|E1|Reported Event|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
490189|NCT00705783|B3|Baseline|Total|Total of all reporting groups
490190|NCT00705783|B2|Baseline|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
490191|NCT00705783|B1|Baseline|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490192|NCT00705783|P3|Participant Flow|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
492363|NCT00715676|P3|Participant Flow|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
490193|NCT00705783|P2|Participant Flow|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490194|NCT00705783|P1|Participant Flow|All Patients|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy. During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. During the Depot Stabilization Phase, patients were stabilized on aripiprazole depot.
490195|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
490196|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490197|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
490198|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490199|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
490200|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490201|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
490202|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490203|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
490204|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490205|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
490206|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490207|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
490208|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490209|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
490210|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490211|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
490212|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490213|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
490214|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490215|NCT00705783|E5|Reported Event|Placebo Depot - Depot Maintenance Phase|Patients received placebo intramuscularly every 28 days for 52 weeks.
490216|NCT00705783|E4|Reported Event|Aripiprazole Depot - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
490217|NCT00705783|E3|Reported Event|Depot Stabilization Phase|During the IM Depot Stabilization Phase, patients were stabilized on aripiprazole IM depot.
490218|NCT00705783|E2|Reported Event|Oral Stabilization Phase|During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
490219|NCT00705783|E1|Reported Event|Conversion Phase|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
490220|NCT00705874|B8|Baseline|Total|Total of all reporting groups
490221|NCT00705874|B7|Baseline|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
490222|NCT00705874|B6|Baseline|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
490223|NCT00705874|B5|Baseline|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
490224|NCT00705874|B4|Baseline|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
490225|NCT00705874|B3|Baseline|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
490226|NCT00705874|B2|Baseline|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
490227|NCT00705874|B1|Baseline|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
490228|NCT00705874|P7|Participant Flow|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
490229|NCT00705874|P6|Participant Flow|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
490230|NCT00705874|P5|Participant Flow|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
490231|NCT00705874|P4|Participant Flow|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
490232|NCT00705874|P3|Participant Flow|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
490233|NCT00705874|P2|Participant Flow|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
490234|NCT00705874|P1|Participant Flow|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
490235|NCT00705874|O7|Outcome|PG11047/Sunitinib|"PG-11047 in combination with Sunitinib.
The MTD of PG-11047 was undetermineable due to only 2 evaluable patients in this treatment group"
490236|NCT00705874|O6|Outcome|PG11047/5-Flurouracil|CGC-11047 in combination with 5-Flurouracil / Leucovorin
490237|NCT00705874|O5|Outcome|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
490238|NCT00705874|O4|Outcome|PG11047/Erlotinib|PG-11047 in combination with Erlotinib
490239|NCT00705874|O3|Outcome|PG11047/Bevacizumab|PG-11047 in combination with Bevacizumab
490240|NCT00705874|O2|Outcome|PG11047/Docetaxel|PG-11047 in combination with Docetaxel
490241|NCT00705874|O1|Outcome|PG11047/Gemcitabine|PG-11047 in combination with Gemcitabine
490242|NCT00705874|E7|Reported Event|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
490243|NCT00705874|E6|Reported Event|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
490244|NCT00705874|E5|Reported Event|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
490245|NCT00705874|E4|Reported Event|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
490246|NCT00705874|E3|Reported Event|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
490247|NCT00705874|E2|Reported Event|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
490248|NCT00705874|E1|Reported Event|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
490249|NCT00705939|B4|Baseline|Total|Total of all reporting groups
490250|NCT00705939|B3|Baseline|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
490251|NCT00705939|B2|Baseline|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
490252|NCT00705939|B1|Baseline|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
490253|NCT00705939|P3|Participant Flow|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
490254|NCT00705939|P2|Participant Flow|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
490255|NCT00705939|P1|Participant Flow|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
490256|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
490257|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
490258|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
490259|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
490361|NCT00706134|P2|Participant Flow|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
490260|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
490261|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
490262|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
490263|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
490264|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
490265|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
490266|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
490267|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
490268|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
490269|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
490270|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
490271|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
490272|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
490273|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
490274|NCT00705939|E3|Reported Event|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
490275|NCT00705939|E2|Reported Event|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
490276|NCT00705939|E1|Reported Event|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
490277|NCT00706004|B1|Baseline|Lubiprostone|24 micrograms twice daily
490278|NCT00706004|P1|Participant Flow|Lubiprostone|24 micrograms twice daily
490279|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490280|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490281|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490282|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490283|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490284|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490285|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490286|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490287|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490288|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490289|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490290|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490291|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490292|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490293|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490294|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490295|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490296|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
490297|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
490298|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
490299|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
490300|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
490301|NCT00706004|E1|Reported Event|Lubiprostone|24 micrograms twice daily
490302|NCT00706095|B4|Baseline|Total|Total of all reporting groups
490303|NCT00706095|B3|Baseline|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
490304|NCT00706095|B2|Baseline|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
490305|NCT00706095|B1|Baseline|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
490306|NCT00706095|P3|Participant Flow|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
490307|NCT00706095|P2|Participant Flow|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
490308|NCT00706095|P1|Participant Flow|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
490309|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
490310|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
490311|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
490312|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
490313|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
490314|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
490315|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
490316|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
490317|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
490318|NCT00706095|E3|Reported Event|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
490319|NCT00706095|E2|Reported Event|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
490320|NCT00706095|E1|Reported Event|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
490321|NCT00706121|B5|Baseline|Total|Total of all reporting groups
490322|NCT00706121|B4|Baseline|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years"
490323|NCT00706121|B3|Baseline|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years"
490324|NCT00706121|B2|Baseline|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
490325|NCT00706121|B1|Baseline|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years"
490326|NCT00706121|P4|Participant Flow|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years"
490327|NCT00706121|P3|Participant Flow|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years"
490328|NCT00706121|P2|Participant Flow|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
490329|NCT00706121|P1|Participant Flow|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years"
490330|NCT00706121|O2|Outcome|Vitamin E Placebo|Vitamin E placebo +/- selenium
490331|NCT00706121|O1|Outcome|Active Vitamin E|Active vitamin E +/- selenium
490332|NCT00706121|O2|Outcome|Vitamin E Placebo|Vitamin E placebo +/- selenium
490333|NCT00706121|O1|Outcome|Active Vitamin E|Active vitamin E +/- selenium
490334|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- vitamin E
490335|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- vitamin E
490336|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- vitamin E
490337|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- vitamin E
490338|NCT00706121|O2|Outcome|Vitamin E Placebo|Vitamin E placebo +/- selenium
490339|NCT00706121|O1|Outcome|Active Vitamin E|Active vitamin E +/- selenium
490340|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- vitamin E
490341|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- vitamin E
490342|NCT00706121|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
490343|NCT00706121|O3|Outcome|Combination|Vitamin E + selenium
490344|NCT00706121|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
490345|NCT00706121|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
490346|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- Vitamin E
490347|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- Vitamin E
490348|NCT00706121|O2|Outcome|Selenium Placebo|Selenium Placebo +/- Vitamin E
490349|NCT00706121|O1|Outcome|Active Selenium|Active Selenium +/- Vitamin E
490350|NCT00706121|E4|Reported Event|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years"
490351|NCT00706121|E3|Reported Event|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years"
490352|NCT00706121|E2|Reported Event|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
490353|NCT00706121|E1|Reported Event|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years"
490354|NCT00706134|B5|Baseline|Total|Total of all reporting groups
490355|NCT00706134|B4|Baseline|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
490356|NCT00706134|B3|Baseline|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
490357|NCT00706134|B2|Baseline|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
490358|NCT00706134|B1|Baseline|Placebo|Placebo tablet taken once daily in the morning with a light meal.
490359|NCT00706134|P4|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
490360|NCT00706134|P3|Participant Flow|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
490362|NCT00706134|P1|Participant Flow|Placebo|Placebo tablet taken once daily in the morning with a light meal.
490363|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
490364|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
490365|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
490366|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
490367|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
490368|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
490369|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
490370|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
490371|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
490372|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
490373|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
490374|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
490375|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
490376|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
490377|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
490378|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
490379|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
503631|NCT00746187|B3|Baseline|Total|Total of all reporting groups
490383|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
490384|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
490385|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
490386|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
490387|NCT00706134|E4|Reported Event|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
490388|NCT00706134|E3|Reported Event|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
490389|NCT00706134|E2|Reported Event|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
490390|NCT00706134|E1|Reported Event|Placebo|Placebo tablet taken once daily in the morning with a light meal.
490391|NCT00706329|B1|Baseline|Deflux|Treatment with Deflux.
490392|NCT00706329|P1|Participant Flow|Deflux|Treatment with Deflux.
490393|NCT00706329|O1|Outcome|Close Belly Button or Umbilical Hernia|
490394|NCT00706329|E1|Reported Event|Deflux|Treatment with Deflux.
490395|NCT00706342|B1|Baseline|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
490396|NCT00706342|P1|Participant Flow|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
490397|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
490398|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
490399|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
490400|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
490401|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
490402|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
490403|NCT00706342|E1|Reported Event|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
490404|NCT00706355|B5|Baseline|Total|Total of all reporting groups
490405|NCT00706355|B4|Baseline|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490406|NCT00706355|B3|Baseline|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490407|NCT00706355|B2|Baseline|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490408|NCT00706355|B1|Baseline|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490409|NCT00706355|P4|Participant Flow|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490410|NCT00706355|P3|Participant Flow|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490411|NCT00706355|P2|Participant Flow|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490412|NCT00706355|P1|Participant Flow|PF-04217903 50 mg|Two tablets 25 milligram (mg) PF-04217903 administered orally twice a day in continuous 21-day cycles.
490413|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490414|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490415|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490416|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490417|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490418|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490419|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490420|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490421|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490422|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490423|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490424|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490425|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490426|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490427|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490428|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490429|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490430|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490431|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490432|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490433|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490434|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490435|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490436|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490437|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490438|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490439|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490440|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490441|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490442|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490443|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490444|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490445|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490446|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490447|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490448|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490449|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490450|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490451|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490452|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490453|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490454|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490455|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490456|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490457|NCT00706355|O1|Outcome|All Treated Participants|All participants who received PF-04217903 tablet (50 mg, 100 mg, 200 mg and 150 mg) orally twice a day in continuous 21-day cycles.
490458|NCT00706355|O1|Outcome|All Treated Participants|All participants who received PF-04217903 tablet (50 mg, 100 mg, 200 mg and 150 mg) orally twice a day in continuous 21-day cycles.
490459|NCT00706355|E4|Reported Event|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490460|NCT00706355|E3|Reported Event|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490461|NCT00706355|E2|Reported Event|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490462|NCT00706355|E1|Reported Event|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
490463|NCT00706433|B5|Baseline|Total|Total of all reporting groups
490464|NCT00706433|B4|Baseline|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490465|NCT00706433|B3|Baseline|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490466|NCT00706433|B2|Baseline|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490467|NCT00706433|B1|Baseline|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490468|NCT00706433|P4|Participant Flow|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490469|NCT00706433|P3|Participant Flow|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490470|NCT00706433|P2|Participant Flow|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490471|NCT00706433|P1|Participant Flow|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490472|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490473|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490474|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490475|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490476|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490477|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490478|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490479|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490480|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490481|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490482|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490483|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490484|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490485|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490486|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490487|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490488|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490489|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490490|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490491|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490492|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490493|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490494|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490495|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490496|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490497|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490498|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490499|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
491168|NCT00706914|B4|Baseline|Total|Total of all reporting groups
490500|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490501|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490502|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490503|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490504|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490505|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490506|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490507|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490508|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490509|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490510|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490511|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490512|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490513|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490514|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490515|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490516|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490517|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490518|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490519|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490520|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490521|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490522|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490523|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490524|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490525|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490526|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490527|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490528|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490529|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490530|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490531|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490532|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490533|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490534|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490535|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
491097|NCT00706849|P1|Participant Flow|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
490536|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490537|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490538|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490539|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490540|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490541|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490542|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490543|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490544|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490545|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490546|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490547|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490548|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490549|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490550|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490551|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490552|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490553|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490554|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490555|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490556|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490557|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490558|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490559|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490560|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490561|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490562|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490563|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490564|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490565|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490566|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490567|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490568|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490569|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490570|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490571|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
491098|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
490572|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490573|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490574|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490575|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490576|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490577|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490578|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490579|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490580|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490581|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490582|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490583|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490584|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490585|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490586|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490587|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490588|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490589|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490590|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490591|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490592|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490593|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490594|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490595|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490596|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490597|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490598|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490599|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490600|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490601|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490602|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490603|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490604|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490605|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490606|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490607|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
491099|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
490608|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490609|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490610|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490611|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490612|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490613|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490614|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490615|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490616|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490617|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490618|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490619|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490620|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490621|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490622|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490623|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490624|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490625|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490626|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490627|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490628|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490629|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490630|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490631|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490632|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490633|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490634|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490635|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490636|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490637|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490638|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490639|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490640|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490641|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490642|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490643|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
491100|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
490644|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490645|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490646|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490647|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490648|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490649|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490650|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490651|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490652|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490653|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490654|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490655|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490656|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490657|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490658|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490659|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490660|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490661|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490662|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490663|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490664|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490665|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490666|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490667|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490668|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490669|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490670|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490671|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490672|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490673|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490674|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490675|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490676|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490677|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490678|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490679|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
491101|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
490680|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490681|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490682|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490683|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490684|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490685|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490686|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490687|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490688|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490689|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490690|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490691|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490692|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490693|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490694|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490695|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490696|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490697|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490698|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490699|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490700|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490701|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490702|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490703|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490704|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490705|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490706|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490707|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490708|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490709|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490710|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490711|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490712|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490713|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490714|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490715|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
491102|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
490716|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490717|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490718|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490719|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490720|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490721|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490722|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490723|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490724|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490725|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490726|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490727|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490728|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490729|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490730|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490731|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490732|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490733|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490734|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490735|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490736|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490737|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490738|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490739|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490740|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490741|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490742|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490743|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490744|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490745|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490746|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490747|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490748|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490749|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490750|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490751|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
491103|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
490752|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490753|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490754|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490755|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490756|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490757|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490758|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490759|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490760|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490761|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490762|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490763|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490764|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490765|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490766|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490767|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490768|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490769|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490770|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490771|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490772|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490773|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490774|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490775|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490776|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490777|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490778|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490779|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490780|NCT00706433|E4|Reported Event|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
490781|NCT00706433|E3|Reported Event|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490782|NCT00706433|E2|Reported Event|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
490783|NCT00706433|E1|Reported Event|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
490784|NCT00706446|B7|Baseline|Total|Total of all reporting groups
490838|NCT00706485|E1|Reported Event|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.
Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
490839|NCT00706550|B3|Baseline|Total|Total of all reporting groups
490840|NCT00706550|B2|Baseline|Arm 2: PV After >6 Months of Antiretroviral Therapy|"Arm 2 received PV after at least 6 months of antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
490978|NCT00706654|E4|Reported Event|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
490785|NCT00706446|B6|Baseline|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490786|NCT00706446|B5|Baseline|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490850|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
490851|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
490787|NCT00706446|B4|Baseline|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490788|NCT00706446|B3|Baseline|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
490789|NCT00706446|B2|Baseline|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490790|NCT00706446|B1|Baseline|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490791|NCT00706446|P6|Participant Flow|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490841|NCT00706550|B1|Baseline|Arm 1: PV Before Starting Antiretroviral Therapy|"Arm 1 received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
490979|NCT00706654|E3|Reported Event|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
490792|NCT00706446|P5|Participant Flow|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490793|NCT00706446|P4|Participant Flow|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490794|NCT00706446|P3|Participant Flow|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
490795|NCT00706446|P2|Participant Flow|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490796|NCT00706446|P1|Participant Flow|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490797|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490798|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490842|NCT00706550|P2|Participant Flow|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
491104|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
490799|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490800|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
490801|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490802|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490803|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490804|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490805|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490843|NCT00706550|P1|Participant Flow|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
491105|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
490806|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
490807|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
492432|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
490808|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490809|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490810|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490811|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490812|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
490844|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
490980|NCT00706654|E2|Reported Event|All Patients - Oral Stabilization Phase|During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
490813|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490814|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490815|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490816|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490817|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490818|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
490819|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490845|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
490910|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490820|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490852|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
490853|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
490854|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
490821|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490822|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490823|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
490824|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
490825|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490826|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
490846|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
490976|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
490827|NCT00706446|E6|Reported Event|6 - LABA/ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
490828|NCT00706446|E5|Reported Event|5 - LABA/ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
490829|NCT00706446|E4|Reported Event|4 - LABA/ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
490830|NCT00706446|E3|Reported Event|3 - Tio/ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
490831|NCT00706446|E2|Reported Event|2 - Tio/ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
490832|NCT00706446|E1|Reported Event|1 - Tio/ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
490833|NCT00706485|B1|Baseline|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.
Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
490834|NCT00706485|P1|Participant Flow|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.
Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
490835|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.
Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
490836|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.
Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
490837|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.
Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
490890|NCT00706589|E2|Reported Event|Placebo|Placebo 2mg,5mg,10mg,15mg
490891|NCT00706589|E1|Reported Event|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg
490847|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
490848|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
490849|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
491119|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
490855|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
490856|NCT00706550|E2|Reported Event|Arm 2: PV After >6 Months of Antiretroviral Therapy|"Arm 2 received PV after at least 6 months of antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
490857|NCT00706550|E1|Reported Event|Arm 1: PV Before Starting Antiretroviral Therapy|"Arm 1 received PV prior to starting antiretroviral treatment.
PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
490858|NCT00706563|B3|Baseline|Total|Total of all reporting groups
490859|NCT00706563|B2|Baseline|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490860|NCT00706563|B1|Baseline|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490861|NCT00706563|P2|Participant Flow|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490862|NCT00706563|P1|Participant Flow|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490863|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490864|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490865|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490866|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490867|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490868|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490869|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490870|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490871|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490872|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490873|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490874|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490875|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490876|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490877|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490878|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490879|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490880|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490881|NCT00706563|E2|Reported Event|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
490882|NCT00706563|E1|Reported Event|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
490883|NCT00706589|B3|Baseline|Total|Total of all reporting groups
490884|NCT00706589|B2|Baseline|Placebo|Placebo 2mg,5mg,10mg,15mg
490885|NCT00706589|B1|Baseline|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg
490886|NCT00706589|P2|Participant Flow|Placebo|Placebo 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol)10mg,15mg, 20mg Mode of administration: P.O
490887|NCT00706589|P1|Participant Flow|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol) Mode of administration: P.O
490888|NCT00706589|O2|Outcome|Placebo|Placebo 2mg,5mg,10mg,15mg, 20mg
490889|NCT00706589|O1|Outcome|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg, 20mg
490893|NCT00706628|B4|Baseline|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.
The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
490894|NCT00706628|B3|Baseline|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490895|NCT00706628|B2|Baseline|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490896|NCT00706628|B1|Baseline|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490916|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490917|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
491271|NCT00707031|B3|Baseline|Total|Total of all reporting groups
490897|NCT00706628|P4|Participant Flow|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.
The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events (AE) reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
490898|NCT00706628|P3|Participant Flow|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490899|NCT00706628|P2|Participant Flow|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490900|NCT00706628|P1|Participant Flow|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490901|NCT00706628|O1|Outcome|Combination Therapy of BIBF 1120 and BIBW 2992|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
C12,14 values of BIBF 1120 BS after sequential alternating 7−days administration of 250 mg BIBF 1120 bid;
C24,7, C24,14 and C24,42 values of BIBW 2992 BS after sequential alternating 7−days administration of 40 mg BIBW 2992 qd"
490902|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490903|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490904|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.
The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
490905|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490906|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490907|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490908|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.
The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
490909|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490977|NCT00706654|E5|Reported Event|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
490911|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490912|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490913|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490914|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490915|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
492433|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
490918|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490919|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490920|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490921|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21 BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490922|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490923|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490924|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490925|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490926|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490927|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490928|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490929|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490930|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21 BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490931|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490932|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490933|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490934|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490935|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490936|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490937|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490938|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490939|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle. The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged. Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
491116|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
490940|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490941|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490942|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490943|NCT00706628|E4|Reported Event|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.
The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
490944|NCT00706628|E3|Reported Event|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.
Treatment regimen:
BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.
Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
490945|NCT00706628|E2|Reported Event|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490946|NCT00706628|E1|Reported Event|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
490947|NCT00706641|B1|Baseline|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
490948|NCT00706641|P1|Participant Flow|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
490949|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
490950|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
491159|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
490951|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
490952|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
490953|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
490954|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
490955|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
490956|NCT00706641|E1|Reported Event|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
490957|NCT00706654|B4|Baseline|Total|Total of all reporting groups
490958|NCT00706654|B3|Baseline|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
490959|NCT00706654|B2|Baseline|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
490960|NCT00706654|B1|Baseline|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
490961|NCT00706654|P4|Participant Flow|Aripiprazole Depot 25 or 50 mg|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
490962|NCT00706654|P3|Participant Flow|Aripiprazole 10-30 mg Orally|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
490963|NCT00706654|P2|Participant Flow|Aripiprazole Depot 300 or 400 mg|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
490964|NCT00706654|P1|Participant Flow|All Patients|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy and during the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
490965|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
490966|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
490967|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
490968|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
490969|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
490970|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
490971|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
490972|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
490973|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
490974|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
490975|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
490981|NCT00706654|E1|Reported Event|All Patients - Conversion Phase|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
490982|NCT00706706|B1|Baseline|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
490983|NCT00706706|P1|Participant Flow|Sunitinib|Sunitinib 50 milligram (mg) capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
490984|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
490985|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
490986|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
490987|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
491117|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
508204|NCT00757666|O2|Outcome|Accelerometer|
490988|NCT00706706|E1|Reported Event|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
490989|NCT00706719|B4|Baseline|Total|Total of all reporting groups
490990|NCT00706719|B3|Baseline|Group C Androxal Wash Out|25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
490991|NCT00706719|B2|Baseline|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
490992|NCT00706719|B1|Baseline|Group A Testim|1% Testim gel applied daily
490993|NCT00706719|P3|Participant Flow|Group C Androxal With Wash Out|25 mg capsules once daily in men who have previously had a 3 month wash out of topical testosterone
490994|NCT00706719|P2|Participant Flow|Group B Androxal no Washout|25 mg Androxal capsules once daily in men who have not previously washed out topical testosterone
490995|NCT00706719|P1|Participant Flow|Group A Testim (Topical Testosterone)|1% Testim gel applied once daily
490996|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
490997|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
490998|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
490999|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
491000|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
491001|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
491002|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
491003|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
491004|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
491005|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
491006|NCT00706719|E3|Reported Event|Androxal Wash Out|25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
491007|NCT00706719|E2|Reported Event|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
491008|NCT00706719|E1|Reported Event|Group A Testim|1% Testim gel applied daily
491009|NCT00706784|B3|Baseline|Total|Total of all reporting groups
491010|NCT00706784|B2|Baseline|36 mg Leuprolide for 3 Days|
491011|NCT00706784|B1|Baseline|18 mg Leuprolide for 3 Days|
491012|NCT00706784|P2|Participant Flow|36 mg Leuprolide for 3 Days|
491013|NCT00706784|P1|Participant Flow|18 mg Leuprolide for 3 Days|
491014|NCT00706784|O2|Outcome|36 mg Leuprolide for 3 Days|
491015|NCT00706784|O1|Outcome|18 mg Leuprolide for 3 Days|
491016|NCT00706784|E2|Reported Event|36 mg Leuprolide for 3 Days|
491017|NCT00706784|E1|Reported Event|18 mg Leuprolide for 3 Days|
491018|NCT00706797|B3|Baseline|Total|Total of all reporting groups
491019|NCT00706797|B2|Baseline|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491020|NCT00706797|B1|Baseline|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491021|NCT00706797|P2|Participant Flow|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491022|NCT00706797|P1|Participant Flow|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491023|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491024|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491095|NCT00706849|B1|Baseline|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491025|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491026|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491027|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491028|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491029|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491030|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491118|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
508205|NCT00757666|O1|Outcome|Minute Ventilation|
491031|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491032|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491033|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491034|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491035|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491036|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491037|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491038|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491039|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491040|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491041|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491042|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491043|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491044|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491045|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491046|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491047|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491048|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491049|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491050|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491051|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491052|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491160|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
491053|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491054|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491055|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491056|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491057|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491058|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491059|NCT00706797|E2|Reported Event|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
491060|NCT00706797|E1|Reported Event|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
491061|NCT00706810|B1|Baseline|All Groups|
491062|NCT00706810|P1|Participant Flow|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.
Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
491063|NCT00706810|O1|Outcome|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.
Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
491064|NCT00706810|O1|Outcome|All Groups|
491065|NCT00706810|E1|Reported Event|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.
Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
491066|NCT00706823|B3|Baseline|Total|Total of all reporting groups
491067|NCT00706823|B2|Baseline|LMA-Unique|Patients who received LMA-Unique for intubation
491068|NCT00706823|B1|Baseline|I-gel-SGA|Patients who received i-gel SGA for intubation
491069|NCT00706823|P2|Participant Flow|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
491070|NCT00706823|P1|Participant Flow|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
491071|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
491072|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
491073|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
491096|NCT00706849|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491074|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
491075|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
491076|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
491077|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
491078|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
491079|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
491080|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
491081|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
491082|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
491083|NCT00706823|E2|Reported Event|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
491084|NCT00706823|E1|Reported Event|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
491085|NCT00706836|B1|Baseline|All 3 Treatments (Cross-Over Design)|"Pregabalin oral tablets (50 mg) Pregabalin oral tables (200 mg) Placebo
All subjects received all 3 treatments on different days.
Sequence data not available."
491086|NCT00706836|P1|Participant Flow|All Study Participants|"Pregabalin oral tablets (50 mg) Pregabalin oral tablets (200 mg) Placebo
All participants received all 3 treatments on different days.
Sequence not available."
491087|NCT00706836|O3|Outcome|Placebo (Crossover)|"Placebo
placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan"
491088|NCT00706836|O2|Outcome|Pregabalin High Dose (Crossover)|"Pregabalin oral tablets (200 mg)
pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan"
491089|NCT00706836|O1|Outcome|Pregabalin Low Dose (Crossover)|"Pregabalin oral tablets (50 mg)
pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan"
491090|NCT00706836|E3|Reported Event|Placebo (Crossover)|"Placebo
placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan"
491091|NCT00706836|E2|Reported Event|Pregabalin High Dose (Crossover)|"Pregabalin oral tablets (200 mg)
pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan"
491092|NCT00706836|E1|Reported Event|Pregabalin Low Dose (Crossover)|"Pregabalin oral tablets (50 mg)
pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan"
491093|NCT00706849|B3|Baseline|Total|Total of all reporting groups
491094|NCT00706849|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491161|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
491106|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491107|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491108|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491109|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491110|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491111|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491112|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491113|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491114|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491115|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
508206|NCT00757666|E2|Reported Event|Minute Ventilation|Minute ventilation
491120|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491121|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491122|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491123|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491124|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491125|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491126|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491127|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491128|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491129|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491130|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491131|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491132|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491133|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491134|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491135|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491136|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491137|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491138|NCT00706849|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
491139|NCT00706849|E1|Reported Event|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
491140|NCT00706901|B4|Baseline|Total|Total of all reporting groups
491141|NCT00706901|B3|Baseline|Arm 3 TCC|Treatment Control condition
491142|NCT00706901|B2|Baseline|Arm 2 IHMD|In-Home-Messaging Device
491143|NCT00706901|B1|Baseline|Arm 1 GMI|Group Motivational Interviewing
491144|NCT00706901|P3|Participant Flow|Arm 3 TCC|Participants in TCC first completed a baseline assessment, then returned 1 week later to attend four TCC sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
491145|NCT00706901|P2|Participant Flow|Arm 2 IHMD|Participants in IHMD first completed a baseline assessment, then received within a 1 week period their IHMD CCHT device to be used on a daily basis for 27 days in their home. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
491146|NCT00706901|P1|Participant Flow|Arm 1 GMI|Participants in GMI first completed a baseline assessment, then returned 1 week later to attend four GMI sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
491147|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
491148|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
491149|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
491150|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
491151|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
491152|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
491153|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
491154|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
491155|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
491156|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
491157|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
491158|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
491169|NCT00706914|B3|Baseline|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
491170|NCT00706914|B2|Baseline|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
491171|NCT00706914|B1|Baseline|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
491172|NCT00706914|P3|Participant Flow|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
491173|NCT00706914|P2|Participant Flow|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
491174|NCT00706914|P1|Participant Flow|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
491175|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
491176|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
491177|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
491178|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
492434|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
491179|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
491180|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
491181|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
491182|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
491183|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
491184|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
491185|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
491186|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
491187|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
491188|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
491189|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
491190|NCT00706914|E3|Reported Event|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
491191|NCT00706914|E2|Reported Event|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
491192|NCT00706914|E1|Reported Event|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
491193|NCT00706966|B1|Baseline|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily"
491194|NCT00706966|P1|Participant Flow|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily"
491195|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 6 months.
491196|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 3 months.
491197|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 1 month.
491198|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at Baseline.
491199|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 6 months.
491200|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 3 months.
491201|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 1 month.
491202|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at Baseline.
491203|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 6 months.
491204|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 3 months.
491205|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 1 month.
491241|NCT00706992|B8|Baseline|Total|Total of all reporting groups
491206|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at Baseline.
491207|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 6 months.
491208|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 3 months.
491209|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 1 month.
491210|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at Baseline.
491211|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 6 months.
491212|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 3 months.
491213|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 1 month.
491214|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at Baseline.
508207|NCT00757666|E1|Reported Event|Accelerometer|Accelerometer
491215|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 6 months.
491216|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 3 months.
491217|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 1 month.
491218|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at baseline.
491219|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
491220|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
491221|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
491222|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at Baseline.
491223|NCT00706966|O1|Outcome|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily"
491224|NCT00706966|O1|Outcome|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride : 6 months of dutasteride 3.5 mg daily"
491225|NCT00706966|E1|Reported Event|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
dutasteride: 6 months of dutasteride 3.5 mg daily"
491226|NCT00706979|B3|Baseline|Total|Total of all reporting groups
491227|NCT00706979|B2|Baseline|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
491228|NCT00706979|B1|Baseline|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
491229|NCT00706979|P2|Participant Flow|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
491230|NCT00706979|P1|Participant Flow|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
491231|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
491232|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
491233|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
491234|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
491235|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
491236|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
491237|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
491238|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
491239|NCT00706979|E2|Reported Event|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
491240|NCT00706979|E1|Reported Event|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
491242|NCT00706992|B7|Baseline|Arm VII|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
491243|NCT00706992|B6|Baseline|Arm VI|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
491244|NCT00706992|B5|Baseline|Arm V|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
491245|NCT00706992|B4|Baseline|Arm IV|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
491246|NCT00706992|B3|Baseline|Arm III|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
491247|NCT00706992|B2|Baseline|Arm II|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
491248|NCT00706992|B1|Baseline|Arm I|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
491249|NCT00706992|P7|Participant Flow|Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
491250|NCT00706992|P6|Participant Flow|Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
491251|NCT00706992|P5|Participant Flow|Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
491252|NCT00706992|P4|Participant Flow|Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
491253|NCT00706992|P3|Participant Flow|Arm III - Adj-4 A2 F5 Cells + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
491254|NCT00706992|P2|Participant Flow|Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
491255|NCT00706992|P1|Participant Flow|Arm I - Adj-4 A2 F5 Cells|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
491256|NCT00706992|O7|Outcome|Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
491257|NCT00706992|O6|Outcome|Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
491258|NCT00706992|O5|Outcome|Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
491259|NCT00706992|O4|Outcome|Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
491260|NCT00706992|O3|Outcome|Arm III - Adj-4 A2 F5 Cells + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
491261|NCT00706992|O2|Outcome|Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
491262|NCT00706992|O1|Outcome|Arm I - Adj-4 A2 F5 Cells|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
491263|NCT00706992|O1|Outcome|Arm I - 6|Arm I - Adj-4 A2 F5 cells Arm II-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide Arm III-Adj-4 A2 F5 cells + SQ IL-2 Arm IV-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide+SQ IL-2 Arm V-Adj-4 A2 F5 cells + ALVAC MART-1:26-35(27L) Vaccine Arm VI-Adj-4 A2 F5 cells + ALVAC MART-1 Vaccine + SQ IL-2
491264|NCT00706992|E7|Reported Event|Arm VII|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
491316|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491265|NCT00706992|E6|Reported Event|Arm VI|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
491266|NCT00706992|E5|Reported Event|Arm V|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
491267|NCT00706992|E4|Reported Event|Arm IV|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
491268|NCT00706992|E3|Reported Event|Arm III|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
491269|NCT00706992|E2|Reported Event|Arm II|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
491270|NCT00706992|E1|Reported Event|Arm I|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
491272|NCT00707031|B2|Baseline|Exenatide|1-step initiation regimen of exenatide: 5 mcg BID subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment.
491273|NCT00707031|B1|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
491274|NCT00707031|P2|Participant Flow|Exenatide|1-step initiation regimen of exenatide: 5 mcg twice daily (BID) subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment.
491275|NCT00707031|P1|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
491276|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
491277|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
491278|NCT00707031|O2|Outcome|Exenatide|2-step initiation regimen of exenatide.
491279|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
491280|NCT00707031|O2|Outcome|Exenatide|2-step initiation regimen of exenatide.
491281|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
491282|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
491283|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
491284|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
491285|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
491286|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
491287|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
491288|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
491289|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
491290|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
491291|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
491292|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
491293|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
491294|NCT00707031|E2|Reported Event|Exenatide|1-step initiation regimen of exenatide.
491295|NCT00707031|E1|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
491296|NCT00707057|B3|Baseline|Total|Total of all reporting groups
491297|NCT00707057|B2|Baseline|Placebo|Participants received placebo tablet twice daily (BID)
491298|NCT00707057|B1|Baseline|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491299|NCT00707057|P2|Participant Flow|Placebo|Participants received placebo tablet twice daily (BID)
491300|NCT00707057|P1|Participant Flow|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491301|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491302|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491303|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491304|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491305|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491306|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491307|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491308|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491309|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491310|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491311|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491312|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491313|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491314|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491315|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491317|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491318|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491319|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491320|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491321|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491322|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491323|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491324|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491325|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491326|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491327|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
491328|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491329|NCT00707057|E2|Reported Event|Placebo|Participants received placebo tablet twice daily (BID)
491330|NCT00707057|E1|Reported Event|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
491504|NCT00707746|E2|Reported Event|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
509398|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
491331|NCT00707161|B1|Baseline|Treatment Arm (Radiation Therapy & Cisplatin)|Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
491332|NCT00707161|P1|Participant Flow|Treatment Arm (Radiation Therapy & Cisplatin)|All patients will receive Radiation Therapy and Cisplatin for their melanoma. If appropriate patients will have surgical resection for residual or recurrent melanoma following chemoradiation.
491333|NCT00707161|O1|Outcome|Treatment Arm (Radiation & Cisplatin)|Group of participants receiving Radiation and Cisplatin.
491334|NCT00707161|E1|Reported Event|Treatment Arm (Radiation Therapy & Cisplatin)|Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
491335|NCT00707174|B3|Baseline|Total|Total of all reporting groups
491336|NCT00707174|B2|Baseline|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:
Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
491337|NCT00707174|B1|Baseline|Imiquimod Only|"Topical imiquimod group:
treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist’s ability to evaluate the excised tumor/treatment site."
491338|NCT00707174|P2|Participant Flow|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:
Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
491339|NCT00707174|P1|Participant Flow|Imiquimod Only|"Topical imiquimod group:
treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
491340|NCT00707174|O2|Outcome|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:
Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
491341|NCT00707174|O1|Outcome|Imiquimod Only|"Topical imiquimod group:
treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
491342|NCT00707174|E2|Reported Event|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:
Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
491343|NCT00707174|E1|Reported Event|Imiquimod Only|"Topical imiquimod group:
treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist’s ability to evaluate the excised tumor/treatment site."
491344|NCT00707239|B4|Baseline|Total|Total of all reporting groups
491345|NCT00707239|B3|Baseline|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491346|NCT00707239|B2|Baseline|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491347|NCT00707239|B1|Baseline|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491487|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491488|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491348|NCT00707239|P3|Participant Flow|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491349|NCT00707239|P2|Participant Flow|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491350|NCT00707239|P1|Participant Flow|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491351|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491352|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491353|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491354|NCT00707239|O1|Outcome|Tigecycline or Imipenem/Cilastatin|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously every 12 hrs at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA.
491355|NCT00707239|O1|Outcome|Tigecycline or Imipenem/Cilastatin|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA.
491356|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
491357|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
491358|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
491359|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491360|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491361|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
491362|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491363|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491364|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491365|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491366|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491405|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
491406|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
491367|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491368|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491369|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491370|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491371|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491372|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491373|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491374|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491375|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491376|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491377|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491378|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491379|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491380|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491381|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491382|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491383|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491384|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491385|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491386|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491387|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491388|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491389|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491390|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491391|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491392|NCT00707239|E3|Reported Event|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491393|NCT00707239|E2|Reported Event|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
491394|NCT00707239|E1|Reported Event|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
491395|NCT00707343|B1|Baseline|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.
FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
491396|NCT00707343|P1|Participant Flow|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.
FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
491397|NCT00707343|O1|Outcome|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.
FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
491489|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491398|NCT00707343|E1|Reported Event|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.
FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
491399|NCT00707447|B3|Baseline|Total|Total of all reporting groups
491400|NCT00707447|B2|Baseline|2/PREDIAS|Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
491401|NCT00707447|B1|Baseline|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
491402|NCT00707447|P2|Participant Flow|2/PREDIAS|Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
491403|NCT00707447|P1|Participant Flow|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
491404|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
509399|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
491407|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
491408|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
491409|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
491410|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
491411|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
491412|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
491413|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
491414|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
491415|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
491416|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
491417|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
491418|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
491419|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
491420|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
491421|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
491422|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
491423|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
491424|NCT00707447|E2|Reported Event|2/PREDIAS|Intervention consists of a group programme (PRAEDIAS) aiming at modification of lifestyle
491425|NCT00707447|E1|Reported Event|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
491426|NCT00707486|B1|Baseline|Hemcon Dental Dressing and Gauze With Pressure|In the case of this study, participants served as their own control.
491427|NCT00707486|P1|Participant Flow|Hemcon Dental Dressing With Pressure|Subjects served as their own control. Subject had both the HemCon Dental Dressing and one of two controls: Gelfoam or Gauze with pressure. Subjects had paired extractions; each extraction site within the pair were randomized to the HemCon Dental Dressing or to a control.
491428|NCT00707486|O3|Outcome|Total|
491429|NCT00707486|O2|Outcome|Control: Gauze|
491430|NCT00707486|O1|Outcome|HemCon|Experimental
491431|NCT00707486|O3|Outcome|Total|
491432|NCT00707486|O2|Outcome|Control: Gauze|
491433|NCT00707486|O1|Outcome|HemCon|Experimental
491434|NCT00707486|E1|Reported Event|Hemcon Dental Dressing and Gauze With Pressure|In the case of this study, participants served as their own control.
491435|NCT00707577|B3|Baseline|Total|Total of all reporting groups
491436|NCT00707577|B2|Baseline|Control|No maintenance program provided
491437|NCT00707577|B1|Baseline|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs
Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
491438|NCT00707577|P2|Participant Flow|Control|No maintenance program provided
491490|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
498774|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
491439|NCT00707577|P1|Participant Flow|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs
Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
491440|NCT00707577|O2|Outcome|Control|No maintenance program provided
491498|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491499|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491500|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491501|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491502|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
509400|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
491441|NCT00707577|O1|Outcome|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs
Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
491442|NCT00707577|E2|Reported Event|Control|No maintenance program provided
491443|NCT00707577|E1|Reported Event|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs
Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
491444|NCT00707655|B3|Baseline|Total|Total of all reporting groups
491445|NCT00707655|B2|Baseline|Zalutumumab 8 mg/kg|8 weekly infusions
491446|NCT00707655|B1|Baseline|Zalutumumab 4 mg/kg|8 weekly infusions
491447|NCT00707655|P2|Participant Flow|Zalutumumab 8 mg/kg|8 weekly infusions
491448|NCT00707655|P1|Participant Flow|Zalutumumab 4 mg/kg|8 weekly infusions
491449|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|8 weekly infusions
491450|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|8 weekly infusions
491451|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|8 weekly infusions
491452|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|8 weekly infusions
491453|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|
491454|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|
491455|NCT00707655|E2|Reported Event|Zalutumumab 8 mg/kg|8 weekly infusions
491456|NCT00707655|E1|Reported Event|Zalutumumab 4 mg/kg|8 weekly infusions
491457|NCT00707746|B3|Baseline|Total|Total of all reporting groups
491458|NCT00707746|B2|Baseline|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491459|NCT00707746|B1|Baseline|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491460|NCT00707746|P2|Participant Flow|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491461|NCT00707746|P1|Participant Flow|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491462|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491463|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491464|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491465|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491466|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491467|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491468|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491469|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491470|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491471|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491472|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491473|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491474|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491475|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491476|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491477|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491478|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491479|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491480|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491481|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491482|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491483|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491484|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491485|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491486|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491491|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491492|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491493|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491494|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491495|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491496|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
491497|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491505|NCT00707746|E1|Reported Event|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
491506|NCT00707759|B3|Baseline|Total|Total of all reporting groups
491507|NCT00707759|B2|Baseline|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day
10°days after Tx: 2 mg/kg/d
Day 11 - 20: 1 mg/kg/d
Day 21 - 30: 0.5 mg/kg/d
Day 31 - 60: 0.3 mg/k/d
Week 8 - 12: 0.25 mg/k/d
Week 12 - 16: 0.20 mg/k/d
Week 16 - 20: 0.15 mg/k/d
Month 6 - 12: 0.10 - 0.12 mg/k/d
Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day
10°days after Tx: 2 mg/kg/d
Day 11 - 20: 1 mg/kg/d
Day 21 - 30: 0.5 mg/kg/d
Day 31 - 60: 0.3 mg/k/d
Week 8 - 12: 0.25 mg/k/d
Week 12 - 16: 0.20 mg/k/d
Week 16 - 20: 0.15 mg/k/d
Month 6 - 12: 0.10 - 0.12 mg/k/d"
491508|NCT00707759|B1|Baseline|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.
1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
3°day: Prednisone 2 mg/kg/d in 2 doses
4ºday: Prednisone 1 mg/kg/d in 2 doses
5ºday: Prednisone 0.5 mg/kg/d in 2 doses
6ºday: Prednisone 0.25 mg/kg/d in 2 doses
7ºday: Stop Prednisone
Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.
1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
3°day: Prednisone 2 mg/kg/d in 2 doses
4ºday: Prednisone 1 mg/kg/d in 2 doses
5ºday: Prednisone 0.5 mg/kg/d in 2 doses
6ºday: Prednisone 0.25 mg/kg/d in 2 doses
7ºday: Stop Prednisone"
491509|NCT00707759|P2|Participant Flow|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day
10°days after Tx: 2 mg/kg/d
Day 11 - 20: 1 mg/kg/d
Day 21 - 30: 0.5 mg/kg/d
Day 31 - 60: 0.3 mg/k/d
Week 8 - 12: 0.25 mg/k/d
Week 12 - 16: 0.20 mg/k/d
Week 16 - 20: 0.15 mg/k/d
Month 6 - 12: 0.10 - 0.12 mg/k/d
Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day
10°days after Tx: 2 mg/kg/d
Day 11 - 20: 1 mg/kg/d
Day 21 - 30: 0.5 mg/kg/d
Day 31 - 60: 0.3 mg/k/d
Week 8 - 12: 0.25 mg/k/d
Week 12 - 16: 0.20 mg/k/d
Week 16 - 20: 0.15 mg/k/d
Month 6 - 12: 0.10 - 0.12 mg/k/d"
491510|NCT00707759|P1|Participant Flow|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.
1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
3°day: Prednisone 2 mg/kg/d in 2 doses
4ºday: Prednisone 1 mg/kg/d in 2 doses
5ºday: Prednisone 0.5 mg/kg/d in 2 doses
6ºday: Prednisone 0.25 mg/kg/d in 2 doses
7ºday: Stop Prednisone
Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.
1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
3°day: Prednisone 2 mg/kg/d in 2 doses
4ºday: Prednisone 1 mg/kg/d in 2 doses
5ºday: Prednisone 0.5 mg/kg/d in 2 doses
6ºday: Prednisone 0.25 mg/kg/d in 2 doses
7ºday: Stop Prednisone"
491511|NCT00707759|O2|Outcome|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day
10°days after Tx: 2 mg/kg/d
Day 11 - 20: 1 mg/kg/d
Day 21 - 30: 0.5 mg/kg/d
Day 31 - 60: 0.3 mg/k/d
Week 8 - 12: 0.25 mg/k/d
Week 12 - 16: 0.20 mg/k/d
Week 16 - 20: 0.15 mg/k/d
Month 6 - 12: 0.10 - 0.12 mg/k/d
Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day
10°days after Tx: 2 mg/kg/d
Day 11 - 20: 1 mg/kg/d
Day 21 - 30: 0.5 mg/kg/d
Day 31 - 60: 0.3 mg/k/d
Week 8 - 12: 0.25 mg/k/d
Week 12 - 16: 0.20 mg/k/d
Week 16 - 20: 0.15 mg/k/d
Month 6 - 12: 0.10 - 0.12 mg/k/d"
491512|NCT00707759|O1|Outcome|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.
1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
3°day: Prednisone 2 mg/kg/d in 2 doses
4ºday: Prednisone 1 mg/kg/d in 2 doses
5ºday: Prednisone 0.5 mg/kg/d in 2 doses
6ºday: Prednisone 0.25 mg/kg/d in 2 doses
7ºday: Stop Prednisone
Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.
1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
3°day: Prednisone 2 mg/kg/d in 2 doses
4ºday: Prednisone 1 mg/kg/d in 2 doses
5ºday: Prednisone 0.5 mg/kg/d in 2 doses
6ºday: Prednisone 0.25 mg/kg/d in 2 doses
7ºday: Stop Prednisone"
491513|NCT00707759|E2|Reported Event|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day
10°days after Tx: 2 mg/kg/d
Day 11 - 20: 1 mg/kg/d
Day 21 - 30: 0.5 mg/kg/d
Day 31 - 60: 0.3 mg/k/d
Week 8 - 12: 0.25 mg/k/d
Week 12 - 16: 0.20 mg/k/d
Week 16 - 20: 0.15 mg/k/d
Month 6 - 12: 0.10 - 0.12 mg/k/d
Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day
10°days after Tx: 2 mg/kg/d
Day 11 - 20: 1 mg/kg/d
Day 21 - 30: 0.5 mg/kg/d
Day 31 - 60: 0.3 mg/k/d
Week 8 - 12: 0.25 mg/k/d
Week 12 - 16: 0.20 mg/k/d
Week 16 - 20: 0.15 mg/k/d
Month 6 - 12: 0.10 - 0.12 mg/k/d"
491551|NCT00707954|E3|Reported Event|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
492176|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
491514|NCT00707759|E1|Reported Event|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.
1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
3°day: Prednisone 2 mg/kg/d in 2 doses
4ºday: Prednisone 1 mg/kg/d in 2 doses
5ºday: Prednisone 0.5 mg/kg/d in 2 doses
6ºday: Prednisone 0.25 mg/kg/d in 2 doses
7ºday: Stop Prednisone
Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.
1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
3°day: Prednisone 2 mg/kg/d in 2 doses
4ºday: Prednisone 1 mg/kg/d in 2 doses
5ºday: Prednisone 0.5 mg/kg/d in 2 doses
6ºday: Prednisone 0.25 mg/kg/d in 2 doses
7ºday: Stop Prednisone"
491515|NCT00707863|B3|Baseline|Total|Total of all reporting groups
491516|NCT00707863|B2|Baseline|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
491517|NCT00707863|B1|Baseline|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
491518|NCT00707863|P2|Participant Flow|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
492435|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
491519|NCT00707863|P1|Participant Flow|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
491520|NCT00707863|O2|Outcome|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
491521|NCT00707863|O1|Outcome|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
491522|NCT00707863|E2|Reported Event|Subjects Age: 26 - 50|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50
Escitalopram: 10 mg of Escitalopram by mouth per day for 8 weeks"
491523|NCT00707863|E1|Reported Event|Subjects Age: 18 - 25|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25
Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
491524|NCT00707915|B1|Baseline|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
491525|NCT00707915|P1|Participant Flow|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
491526|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
491527|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
491528|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
491529|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
491530|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
491531|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
491532|NCT00707915|E1|Reported Event|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
491533|NCT00707954|B6|Baseline|Total|Total of all reporting groups
491534|NCT00707954|B5|Baseline|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491535|NCT00707954|B4|Baseline|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491536|NCT00707954|B3|Baseline|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491537|NCT00707954|B2|Baseline|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491538|NCT00707954|B1|Baseline|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491539|NCT00707954|P5|Participant Flow|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491540|NCT00707954|P4|Participant Flow|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491541|NCT00707954|P3|Participant Flow|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491542|NCT00707954|P2|Participant Flow|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491543|NCT00707954|P1|Participant Flow|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491544|NCT00707954|O5|Outcome|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491545|NCT00707954|O4|Outcome|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491546|NCT00707954|O3|Outcome|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491547|NCT00707954|O2|Outcome|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491548|NCT00707954|O1|Outcome|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491549|NCT00707954|E5|Reported Event|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491550|NCT00707954|E4|Reported Event|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491552|NCT00707954|E2|Reported Event|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491553|NCT00707954|E1|Reported Event|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
491554|NCT00707967|B4|Baseline|Total|Total of all reporting groups
491555|NCT00707967|B3|Baseline|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491556|NCT00707967|B2|Baseline|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491557|NCT00707967|B1|Baseline|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491558|NCT00707967|P3|Participant Flow|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491559|NCT00707967|P2|Participant Flow|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491560|NCT00707967|P1|Participant Flow|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491561|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491562|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491563|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491564|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491565|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491566|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491567|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491568|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491569|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491570|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491571|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491572|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491573|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491574|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491575|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491576|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491577|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491578|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491579|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491580|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491581|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491582|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491636|NCT00707993|P2|Participant Flow|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491583|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491584|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491585|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491586|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491587|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491588|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491643|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491589|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491590|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491591|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491592|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491593|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491594|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491595|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491596|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491597|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491598|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491599|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491600|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491601|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491602|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491603|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491604|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491605|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491606|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491607|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491608|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491609|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491610|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491611|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491612|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491737|NCT00708071|O1|Outcome|Complete Resolution of Ecchymosis With FS VH S/D 4 But Not SoC|
491613|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491614|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491615|NCT00707967|E3|Reported Event|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491616|NCT00707967|E2|Reported Event|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491617|NCT00707967|E1|Reported Event|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
491644|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
509401|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
491618|NCT00707980|B1|Baseline|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491619|NCT00707980|P1|Participant Flow|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491620|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491621|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491622|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491623|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491624|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491625|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491626|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491627|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491628|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491629|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491630|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491631|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491632|NCT00707980|E1|Reported Event|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
491633|NCT00707993|B3|Baseline|Total|Total of all reporting groups
491634|NCT00707993|B2|Baseline|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491635|NCT00707993|B1|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
498775|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
491637|NCT00707993|P1|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491638|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491639|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491640|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491641|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491642|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
510714|NCT00763451|B5|Baseline|Total|Total of all reporting groups
491645|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491646|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491647|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491648|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491649|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491650|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491651|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491652|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491653|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491654|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491655|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491656|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491657|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491658|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491659|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491660|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491661|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491662|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491663|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491664|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491665|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491666|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491667|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491668|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491669|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491670|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491671|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491672|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491673|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491674|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491675|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491676|NCT00707993|E2|Reported Event|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
491677|NCT00707993|E1|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
491678|NCT00708019|B3|Baseline|Total|Total of all reporting groups
491679|NCT00708019|B2|Baseline|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
491747|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491680|NCT00708019|B1|Baseline|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
491681|NCT00708019|P2|Participant Flow|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
491682|NCT00708019|P1|Participant Flow|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
491683|NCT00708019|O2|Outcome|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
491684|NCT00708019|O1|Outcome|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
491685|NCT00708019|O2|Outcome|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
491738|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491739|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491740|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491741|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
498776|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
491686|NCT00708019|O1|Outcome|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
491748|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491749|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
492436|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
491687|NCT00708019|E2|Reported Event|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
491688|NCT00708019|E1|Reported Event|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
491689|NCT00708032|B3|Baseline|Total|Total of all reporting groups
491690|NCT00708032|B2|Baseline|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
491691|NCT00708032|B1|Baseline|Spectacles|spectacles worn daily for 12 months
491692|NCT00708032|P2|Participant Flow|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
491693|NCT00708032|P1|Participant Flow|Spectacles|spectacles worn daily for 12 months
491694|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
491695|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
491696|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
491697|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
491698|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
491699|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
491700|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
491701|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
491702|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
491703|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
491704|NCT00708032|E2|Reported Event|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
491705|NCT00708032|E1|Reported Event|Spectacles|spectacles worn daily for 12 months
491706|NCT00708071|B1|Baseline|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491707|NCT00708071|P1|Participant Flow|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491708|NCT00708071|O1|Outcome|Facelift Participants|
491709|NCT00708071|O3|Outcome|SoC Looks Better|
491710|NCT00708071|O2|Outcome|FS VH S/D 4 Looks Better|
491711|NCT00708071|O1|Outcome|No Difference|
491712|NCT00708071|O1|Outcome|Facelift Participants|
491713|NCT00708071|O1|Outcome|Facelift Participants|
491714|NCT00708071|O8|Outcome|SoC - Day 14|
491715|NCT00708071|O7|Outcome|FS VH S/D 4 - Day 14|
491716|NCT00708071|O6|Outcome|SoC - Day 10|
491717|NCT00708071|O5|Outcome|FS VH S/D 4 - Day 10|
491718|NCT00708071|O4|Outcome|SoC - Day 7|
491719|NCT00708071|O3|Outcome|FS VH S/D 4 - Day 7|
491720|NCT00708071|O2|Outcome|SoC - Day 3|
491721|NCT00708071|O1|Outcome|FS VH S/D 4 - Day3|
491722|NCT00708071|O4|Outcome|Participants With No Hematoma/Seroma on Either Side|
491723|NCT00708071|O3|Outcome|Participants With Hematoma/Seroma on Both Sides|
491724|NCT00708071|O2|Outcome|Participants With Hematoma/Seroma on SoC Side|
491725|NCT00708071|O1|Outcome|Participants With Hematoma/Seroma on FS VH S/D 4 Side|
491726|NCT00708071|O2|Outcome|FS VH S/D 4|
491727|NCT00708071|O1|Outcome|Standard of Care (SoC)|
491728|NCT00708071|O2|Outcome|FS VH S/D 4|
491729|NCT00708071|O1|Outcome|Standard of Care (SoC)|
491730|NCT00708071|O4|Outcome|Participants With No Resolution on Either Side|
491731|NCT00708071|O3|Outcome|Participants With Complete Resolution on Both Sides|
491732|NCT00708071|O2|Outcome|Complete Resolution of Edema With SoC But Not FS VH S/D 4|
491733|NCT00708071|O1|Outcome|Complete Resolution of Edema With FS VH S/D 4 But Not SoC|
491734|NCT00708071|O4|Outcome|Participants With No Resolution on Either Side|
491735|NCT00708071|O3|Outcome|Participants With Complete Resolution on Both Sides|
491736|NCT00708071|O2|Outcome|Complete Resolution of Ecchymosis With SoC But Not FS VH S/D 4|
491742|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491743|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491744|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491745|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491746|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491750|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491751|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491752|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491753|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491754|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491755|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491756|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
491757|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
491758|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
491759|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
491760|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
491761|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
491762|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
491763|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
491764|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
491765|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
491766|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
491767|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
491768|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
491769|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
491770|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
491771|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
491772|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
491773|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
491774|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
491775|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
491776|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
491777|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
491778|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
491779|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
491780|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
491781|NCT00708071|E3|Reported Event|Non-localized AEs|AE affected a site other than either side of the face (ie, non-localized AE)
491782|NCT00708071|E2|Reported Event|Localized to FS VH S/D 4 Side of Face|AE was localized to the side of the face which was treated with FS VH S/D 4.
491783|NCT00708071|E1|Reported Event|Localized to SoC Side of Face|AE was localized to the side of the face which was treated with standard of care.
491784|NCT00708097|B1|Baseline|All Randomized Participants|All randomized participants who received at least one of the treatment dentifrices during the study and had at least one safety assessment after using the treatment dentifrice.
491785|NCT00708097|P5|Participant Flow|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491786|NCT00708097|P4|Participant Flow|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491787|NCT00708097|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491830|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
498777|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
491788|NCT00708097|P2|Participant Flow|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491789|NCT00708097|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491790|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
492437|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
491791|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491792|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491793|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491794|NCT00708097|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491795|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491796|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491797|NCT00708097|O3|Outcome|NaMFP/ NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491798|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491799|NCT00708097|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491800|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491801|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491802|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491803|NCT00708097|O2|Outcome|NaF Toothpaste(1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491804|NCT00708097|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491805|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491806|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491807|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491808|NCT00708097|O2|Outcome|NaF Toothpaste(1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491809|NCT00708097|O1|Outcome|NaF/Carbopol Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491810|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491811|NCT00708097|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491812|NCT00708097|E6|Reported Event|Overall|All participants received all treatments during the study
491813|NCT00708097|E5|Reported Event|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491814|NCT00708097|E4|Reported Event|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491815|NCT00708097|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491816|NCT00708097|E2|Reported Event|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491817|NCT00708097|E1|Reported Event|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
491818|NCT00708110|B5|Baseline|Total|Total of all reporting groups
491819|NCT00708110|B4|Baseline|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491820|NCT00708110|B3|Baseline|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491821|NCT00708110|B2|Baseline|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491822|NCT00708110|B1|Baseline|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491823|NCT00708110|P4|Participant Flow|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491824|NCT00708110|P3|Participant Flow|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491825|NCT00708110|P2|Participant Flow|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491826|NCT00708110|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491827|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491828|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491829|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491831|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491832|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491833|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491834|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491835|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491836|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491837|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491838|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491839|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491840|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491841|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491842|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491843|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491844|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491845|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491846|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491847|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491848|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491849|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491850|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491851|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491852|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491853|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491854|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491855|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491856|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491857|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491858|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491859|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491860|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491861|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491862|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491863|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491864|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491865|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491866|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491867|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491868|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491869|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491870|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491871|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491872|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
492092|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
491873|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491874|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491875|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491876|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491877|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491878|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491879|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491880|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491881|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491882|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491883|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491884|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491885|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491886|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491887|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491888|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491889|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491890|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491891|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491892|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491893|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491894|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491895|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491896|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491897|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491898|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491899|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491900|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491901|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491902|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491903|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491904|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491905|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491906|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491907|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491908|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491909|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491910|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491911|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491912|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491913|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491914|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
492093|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
491915|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491916|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491917|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491918|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491919|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491920|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491921|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491922|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491923|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491924|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491925|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491926|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491927|NCT00708110|E4|Reported Event|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
491928|NCT00708110|E3|Reported Event|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
491929|NCT00708110|E2|Reported Event|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
491930|NCT00708110|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
491931|NCT00708123|B1|Baseline|All Study Participants|All randomized participants were included for baseline evaluation.
491932|NCT00708123|P5|Participant Flow|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
491933|NCT00708123|P4|Participant Flow|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491934|NCT00708123|P3|Participant Flow|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491935|NCT00708123|P2|Participant Flow|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491936|NCT00708123|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491937|NCT00708123|O5|Outcome|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
491938|NCT00708123|O4|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491939|NCT00708123|O3|Outcome|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491940|NCT00708123|O2|Outcome|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491941|NCT00708123|O1|Outcome|NaF/ Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491942|NCT00708123|O5|Outcome|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
491943|NCT00708123|O4|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491944|NCT00708123|O3|Outcome|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491945|NCT00708123|O2|Outcome|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491946|NCT00708123|O1|Outcome|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491947|NCT00708123|O3|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial dentures from their mouth.
492177|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
491948|NCT00708123|O2|Outcome|NaF Toothpaste (1350 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491949|NCT00708123|O1|Outcome|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491950|NCT00708123|E5|Reported Event|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
491951|NCT00708123|E4|Reported Event|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491952|NCT00708123|E3|Reported Event|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491953|NCT00708123|E2|Reported Event|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491954|NCT00708123|E1|Reported Event|NaF/ Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
491955|NCT00708162|B3|Baseline|Total|Total of all reporting groups
491956|NCT00708162|B2|Baseline|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491957|NCT00708162|B1|Baseline|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491958|NCT00708162|P2|Participant Flow|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491959|NCT00708162|P1|Participant Flow|Elvitegravir|Elvitegravir (EVG) 85 or 150 mg tablet once daily plus raltegravir (RAL) placebo plus background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491960|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491961|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491962|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491963|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491964|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491965|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491966|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491967|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491968|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491969|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491970|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491971|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491972|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
492056|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
491973|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491974|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491975|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491976|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
492101|NCT00714571|B3|Baseline|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
491977|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491978|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491979|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491980|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491981|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491982|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491983|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491984|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491985|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491986|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491987|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491988|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491989|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491990|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491991|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491992|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491993|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491994|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491995|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
491996|NCT00708162|E3|Reported Event|All Elvitegravir|Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during both the Randomized Phase and Open-Label Phase, and those experienced by participants in the Raltegravir group following switch to EVG in the Open-Label Phase only.
492094|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
491997|NCT00708162|E2|Reported Event|Raltegravir|"Adverse events in this reporting group are those experienced by participants in the Raltegravir group during the Randomized Phase
RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase."
491998|NCT00708162|E1|Reported Event|Elvitegravir|"Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during the Randomized Phase
EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase."
491999|NCT00708175|B3|Baseline|Total|Total of all reporting groups
492000|NCT00708175|B2|Baseline|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
492438|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492001|NCT00708175|B1|Baseline|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
492002|NCT00708175|P2|Participant Flow|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
492003|NCT00708175|P1|Participant Flow|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
492004|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
492005|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
492006|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
492007|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
492008|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
492009|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
492010|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
492011|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
492012|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
492013|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
492014|NCT00708175|E2|Reported Event|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
492015|NCT00708175|E1|Reported Event|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
492016|NCT00708201|B3|Baseline|Total|Total of all reporting groups
492017|NCT00708201|B2|Baseline|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492018|NCT00708201|B1|Baseline|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492019|NCT00708201|P2|Participant Flow|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492020|NCT00708201|P1|Participant Flow|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492021|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492022|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492023|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492024|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492025|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492026|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492027|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492057|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492028|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492029|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492030|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492102|NCT00714571|B2|Baseline|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
492031|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492032|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492033|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492034|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492035|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492036|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492037|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492038|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492039|NCT00708201|E2|Reported Event|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
492040|NCT00708201|E1|Reported Event|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
492041|NCT00708214|B4|Baseline|Total|Total of all reporting groups
492042|NCT00708214|B3|Baseline|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492043|NCT00708214|B2|Baseline|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492044|NCT00708214|B1|Baseline|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492045|NCT00708214|P3|Participant Flow|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492046|NCT00708214|P2|Participant Flow|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492047|NCT00708214|P1|Participant Flow|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492048|NCT00708214|O1|Outcome|Afatinib Overall|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492049|NCT00708214|O1|Outcome|Afatinib Overall|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492050|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492051|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492052|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5 mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492053|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492054|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492055|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
498778|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
492058|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492059|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492060|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492061|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
510797|NCT00763867|B3|Baseline|Total|Total of all reporting groups
492062|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492063|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492064|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492065|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492066|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492067|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492068|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492069|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492070|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492071|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492072|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492073|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492074|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492075|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492076|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492077|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492078|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492079|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492080|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492081|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492082|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492083|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492084|NCT00708214|E3|Reported Event|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492085|NCT00708214|E2|Reported Event|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492086|NCT00708214|E1|Reported Event|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
492087|NCT00714493|B1|Baseline|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
492088|NCT00714493|P1|Participant Flow|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
492089|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
492090|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
492091|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
492095|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
492096|NCT00714493|E1|Reported Event|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
492097|NCT00714571|B7|Baseline|Total|Total of all reporting groups
492098|NCT00714571|B6|Baseline|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
492099|NCT00714571|B5|Baseline|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
492100|NCT00714571|B4|Baseline|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
492103|NCT00714571|B1|Baseline|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
492104|NCT00714571|P6|Participant Flow|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
492105|NCT00714571|P5|Participant Flow|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
492106|NCT00714571|P4|Participant Flow|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
492107|NCT00714571|P3|Participant Flow|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
492108|NCT00714571|P2|Participant Flow|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
492109|NCT00714571|P1|Participant Flow|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
492110|NCT00714571|O6|Outcome|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
492111|NCT00714571|O5|Outcome|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
492112|NCT00714571|O4|Outcome|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
492113|NCT00714571|O3|Outcome|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
492114|NCT00714571|O2|Outcome|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
492115|NCT00714571|O1|Outcome|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
492116|NCT00714571|E6|Reported Event|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
492117|NCT00714571|E5|Reported Event|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
492118|NCT00714571|E4|Reported Event|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
492119|NCT00714571|E3|Reported Event|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
492120|NCT00714571|E2|Reported Event|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
492121|NCT00714571|E1|Reported Event|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
492122|NCT00714688|B4|Baseline|Total|Total of all reporting groups
492123|NCT00714688|B3|Baseline|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
492124|NCT00714688|B2|Baseline|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
492125|NCT00714688|B1|Baseline|Placebo|2 tablets placebo once daily for 13 weeks
492126|NCT00714688|P3|Participant Flow|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
492127|NCT00714688|P2|Participant Flow|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
492128|NCT00714688|P1|Participant Flow|Placebo|2 tablets placebo once daily for 13 weeks
492129|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
492130|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
492131|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
492132|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
492133|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
492134|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
492135|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
492136|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
492137|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
492138|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
492139|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
492140|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
492141|NCT00714688|E3|Reported Event|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
492142|NCT00714688|E2|Reported Event|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
492143|NCT00714688|E1|Reported Event|Placebo|2 tablets placebo once daily for 13 weeks
492144|NCT00714714|B1|Baseline|Combined Arms|All subjects received treatment with both gels in a split-face model
492145|NCT00714714|P1|Participant Flow|Combined Arms|All subjects received treatment with both gels in a split-face model
492175|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
498779|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
492146|NCT00714714|O2|Outcome|Tretinoin|Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
492147|NCT00714714|O1|Outcome|Adapalene|Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
492185|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492186|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492148|NCT00714714|E2|Reported Event|Tretinion|Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
492149|NCT00714714|E1|Reported Event|Adapalene|Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
492150|NCT00715299|B1|Baseline|Arm 1|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.
locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
492151|NCT00715299|P1|Participant Flow|Total Locomotor Training Group|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.
locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
492152|NCT00715299|O1|Outcome|Locomotor Training Group|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.
locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.
18 responded with a walking speed greater than 0.16 m/s, while 9 has a change < 0.16 m/s."
492153|NCT00715299|E1|Reported Event|Arm 1|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.
locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
492154|NCT00715390|B1|Baseline|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
492155|NCT00715390|P1|Participant Flow|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
492156|NCT00715390|O1|Outcome|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
492157|NCT00715390|E1|Reported Event|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
492158|NCT00715403|B8|Baseline|Total|Total of all reporting groups
492159|NCT00715403|B7|Baseline|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492160|NCT00715403|B6|Baseline|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492161|NCT00715403|B5|Baseline|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492162|NCT00715403|B4|Baseline|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492163|NCT00715403|B3|Baseline|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492164|NCT00715403|B2|Baseline|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492165|NCT00715403|B1|Baseline|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492166|NCT00715403|P7|Participant Flow|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492167|NCT00715403|P6|Participant Flow|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492168|NCT00715403|P5|Participant Flow|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492169|NCT00715403|P4|Participant Flow|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492170|NCT00715403|P3|Participant Flow|100mg BID|Patients were treated with 100 mg Nintedanib twice daily (BID).
492171|NCT00715403|P2|Participant Flow|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492172|NCT00715403|P1|Participant Flow|50mg QD|Patients were treated with 50 mg Nintedanib once daily (QD) in the morning.
492173|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492174|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492178|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492179|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492180|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492181|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492182|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492183|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492184|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
511097|NCT00755716|B4|Baseline|Total|Total of all reporting groups
492192|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492193|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492194|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492195|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492196|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492197|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492198|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492199|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492200|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492201|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492202|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492203|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492204|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492205|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492206|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492207|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492208|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492209|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492210|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492211|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492212|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492213|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492214|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492215|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492216|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492217|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492218|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492219|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492220|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492221|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492222|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492223|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492224|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492225|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492226|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492227|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492228|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492229|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492230|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492231|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492232|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492233|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492234|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492235|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492236|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492237|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492238|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492239|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492240|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492241|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492242|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492243|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492244|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492245|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492246|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492247|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492248|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492249|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492250|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492251|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492252|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492253|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492254|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492255|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492256|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492257|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492258|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492259|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492260|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492261|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492262|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492263|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492264|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492265|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492266|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492267|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492268|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492269|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492270|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492271|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492272|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492273|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492274|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492275|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492276|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492277|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492278|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492279|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492280|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492281|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492282|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492283|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492284|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492285|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492286|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492287|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492288|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492289|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492290|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492291|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492292|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492293|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492294|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492295|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492296|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492297|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492298|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492299|NCT00715403|E7|Reported Event|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
492300|NCT00715403|E6|Reported Event|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
492301|NCT00715403|E5|Reported Event|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
492302|NCT00715403|E4|Reported Event|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
492303|NCT00715403|E3|Reported Event|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
492304|NCT00715403|E2|Reported Event|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
492305|NCT00715403|E1|Reported Event|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
492306|NCT00715559|B1|Baseline|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
492307|NCT00715559|P1|Participant Flow|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
492308|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
492309|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
492310|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
492311|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
492312|NCT00715559|E1|Reported Event|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
492313|NCT00715624|B3|Baseline|Total|Total of all reporting groups
492439|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
511747|NCT00764361|O2|Outcome|Placebo|placebo gel
492314|NCT00715624|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
492315|NCT00715624|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
492316|NCT00715624|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
492317|NCT00715624|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
492318|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492319|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492320|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492321|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492322|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492323|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492324|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492325|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492326|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492327|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492328|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492329|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492330|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492331|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492332|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492333|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492334|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492335|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492336|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492337|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492338|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492339|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492340|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
492341|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
492342|NCT00715624|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
492343|NCT00715624|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
492344|NCT00715650|B3|Baseline|Total|Total of all reporting groups
492345|NCT00715650|B2|Baseline|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
492346|NCT00715650|B1|Baseline|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
492347|NCT00715650|P2|Participant Flow|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
492348|NCT00715650|P1|Participant Flow|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
492349|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
492350|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
492351|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
492352|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
492353|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
492354|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
492355|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
492356|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
492357|NCT00715650|E2|Reported Event|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
492358|NCT00715650|E1|Reported Event|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
492359|NCT00715676|B4|Baseline|Total|Total of all reporting groups
492360|NCT00715676|B3|Baseline|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
492361|NCT00715676|B2|Baseline|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
492362|NCT00715676|B1|Baseline|Placebo|Placebo soft gel capsules, oral, once daily
492364|NCT00715676|P2|Participant Flow|220 ng of Vitamin D Analog (DP001)|220 ng DP001 soft gel capsules, oral, once daily DP001 is also known as 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3.
492365|NCT00715676|P1|Participant Flow|Placebo|Placebo soft gel capsules, oral, once daily
492366|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
492367|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
492368|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
492369|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
492370|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
492371|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
492372|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
492373|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
492374|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
492375|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
492376|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
492377|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
492378|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
492379|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
492380|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
492381|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
492382|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
492383|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
492384|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
492385|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
492386|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
492387|NCT00715676|E3|Reported Event|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
492388|NCT00715676|E2|Reported Event|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
492389|NCT00715676|E1|Reported Event|Placebo|Placebo soft gel capsules, oral, once daily
492390|NCT00715741|B5|Baseline|Total|Total of all reporting groups
492391|NCT00715741|B4|Baseline|Fi02 0.9 Without PEEP|90% oxygen without PEEP
492392|NCT00715741|B3|Baseline|Fi02 0.9 With PEEP|90% oxygen plus PEEP
492393|NCT00715741|B2|Baseline|Fi02 0.3 Without PEEP|30% oxygen without PEEP
492394|NCT00715741|B1|Baseline|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
492395|NCT00715741|P4|Participant Flow|Fi02 0.9 Without PEEP|90% oxygen without PEEP
492396|NCT00715741|P3|Participant Flow|Fi02 0.9 With PEEP|90% oxygen plus PEEP
492397|NCT00715741|P2|Participant Flow|Fi02 0.3 Without PEEP|30% oxygen without PEEP
492398|NCT00715741|P1|Participant Flow|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
492399|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
492400|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
492401|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
492402|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
492403|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
492404|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
492405|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
492406|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
492407|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
492408|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
492409|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
492410|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
492411|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
492412|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
492413|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
492414|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
492415|NCT00715741|E4|Reported Event|Fi02 0.9 Without PEEP|90% oxygen without PEEP
492416|NCT00715741|E3|Reported Event|Fi02 0.9 With PEEP|90% oxygen plus PEEP
492417|NCT00715741|E2|Reported Event|Fi02 0.3 Without PEEP|30% oxygen without PEEP
492418|NCT00715741|E1|Reported Event|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
492419|NCT00715754|B1|Baseline|Infants|
492420|NCT00715754|P1|Participant Flow|All Infants|One group comprised all infants evaluated.
492421|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
492422|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
492423|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
492424|NCT00715754|E1|Reported Event|All Infants|One group comprised all infants evaluated.
492425|NCT00715884|B3|Baseline|Total|Total of all reporting groups
492426|NCT00715884|B2|Baseline|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492427|NCT00715884|B1|Baseline|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492428|NCT00715884|P2|Participant Flow|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492429|NCT00715884|P1|Participant Flow|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492430|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492431|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492440|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492441|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492442|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492443|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492444|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492445|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492446|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492447|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492448|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492449|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492450|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492451|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492452|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492453|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492454|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492455|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492456|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492457|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492458|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492459|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492460|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492461|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492462|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492463|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492464|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492465|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492466|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492467|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492468|NCT00715884|E2|Reported Event|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
492469|NCT00715884|E1|Reported Event|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
492470|NCT00715910|B5|Baseline|Total|Total of all reporting groups
492471|NCT00715910|B4|Baseline|Nimenrix naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492472|NCT00715910|B3|Baseline|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492473|NCT00715910|B2|Baseline|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492474|NCT00715910|B1|Baseline|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492475|NCT00715910|P6|Participant Flow|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492476|NCT00715910|P5|Participant Flow|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492477|NCT00715910|P4|Participant Flow|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492478|NCT00715910|P3|Participant Flow|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492479|NCT00715910|P2|Participant Flow|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492480|NCT00715910|P1|Participant Flow|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492481|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492482|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492483|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492484|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492485|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492486|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492487|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492488|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492489|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492490|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492491|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492492|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492493|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492494|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492495|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492496|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492497|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492498|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492499|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492613|NCT00716092|E2|Reported Event|BI1356|Patients randomized to receive treatment with BI1356 5 mg
492500|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492501|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492502|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5
492503|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492504|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492505|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492506|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492507|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492508|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492509|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492510|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492511|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492512|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492513|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492514|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492515|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492516|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492517|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492518|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492519|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492520|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492521|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492522|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492523|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492524|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492525|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492526|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492527|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492528|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492529|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492530|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492531|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492532|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492533|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492534|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492535|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492536|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
498780|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
492537|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492538|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492539|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492540|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492541|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492542|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492543|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492544|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492545|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492546|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492547|NCT00715910|E6|Reported Event|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492548|NCT00715910|E5|Reported Event|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492720|NCT00716456|O1|Outcome|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
492721|NCT00716456|E3|Reported Event|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
492549|NCT00715910|E4|Reported Event|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
492550|NCT00715910|E3|Reported Event|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492551|NCT00715910|E2|Reported Event|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
492552|NCT00715910|E1|Reported Event|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
492553|NCT00715949|B1|Baseline|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
492554|NCT00715949|P1|Participant Flow|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury participating in computerized neurocognitive testing
492555|NCT00715949|O1|Outcome|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
492556|NCT00715949|E1|Reported Event|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
492557|NCT00715962|B3|Baseline|Total|Total of all reporting groups
492558|NCT00715962|B2|Baseline|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.
Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
492559|NCT00715962|B1|Baseline|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.
Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.
Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
492560|NCT00715962|P2|Participant Flow|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.
Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
492561|NCT00715962|P1|Participant Flow|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.
Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.
Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
492562|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.
Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
492614|NCT00716092|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
492615|NCT00716417|B11|Baseline|Total|Total of all reporting groups
492616|NCT00716417|B10|Baseline|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492563|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.
Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.
Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
492564|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.
Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
492565|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.
Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.
Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
492722|NCT00716456|E2|Reported Event|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
492723|NCT00716456|E1|Reported Event|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
492566|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.
Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
492567|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus a behavioral intervention that encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.
Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.
Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
492568|NCT00715962|E2|Reported Event|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.
Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
492569|NCT00715962|E1|Reported Event|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.
Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.
Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
492570|NCT00716079|B3|Baseline|Total|Total of all reporting groups
492571|NCT00716079|B2|Baseline|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.
Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
492572|NCT00716079|B1|Baseline|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.
Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
492573|NCT00716079|P2|Participant Flow|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.
Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
492574|NCT00716079|P1|Participant Flow|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.
Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
492703|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492704|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492575|NCT00716079|O2|Outcome|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.
Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
492576|NCT00716079|O1|Outcome|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.
Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
492577|NCT00716079|O2|Outcome|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.
Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
492759|NCT00716742|B4|Baseline|Total|Total of all reporting groups
492760|NCT00716742|B3|Baseline|Xalatan®|latanoprost 0.005%
492578|NCT00716079|O1|Outcome|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.
Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
492579|NCT00716079|E2|Reported Event|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.
Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
492580|NCT00716079|E1|Reported Event|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.
Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
492581|NCT00716092|B4|Baseline|Total|Total of all reporting groups
492582|NCT00716092|B3|Baseline|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
492583|NCT00716092|B2|Baseline|BI1356|Patients randomized to receive treatment with BI1356 5 mg
492584|NCT00716092|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
492585|NCT00716092|P3|Participant Flow|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
492586|NCT00716092|P2|Participant Flow|BI1356|Patients randomized to receive treatment with BI1356 5 mg
492587|NCT00716092|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
492588|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
492589|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
492590|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
492591|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
492592|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
492593|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
492594|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
492595|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
492596|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
492597|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
492598|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
492599|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
492600|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
492601|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
492602|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
492603|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
492604|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
492605|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
492606|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
492607|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
492608|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
492609|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
492610|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
492611|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
492612|NCT00716092|E3|Reported Event|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
492617|NCT00716417|B9|Baseline|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492618|NCT00716417|B8|Baseline|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492619|NCT00716417|B7|Baseline|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492620|NCT00716417|B6|Baseline|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492621|NCT00716417|B5|Baseline|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492622|NCT00716417|B4|Baseline|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492761|NCT00716742|B2|Baseline|Travatan®|travoprost 0.004%
492623|NCT00716417|B3|Baseline|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492624|NCT00716417|B2|Baseline|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492625|NCT00716417|B1|Baseline|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492626|NCT00716417|P10|Participant Flow|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492627|NCT00716417|P9|Participant Flow|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492628|NCT00716417|P8|Participant Flow|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492629|NCT00716417|P7|Participant Flow|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492630|NCT00716417|P6|Participant Flow|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492631|NCT00716417|P5|Participant Flow|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492632|NCT00716417|P4|Participant Flow|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492633|NCT00716417|P3|Participant Flow|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492634|NCT00716417|P2|Participant Flow|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492635|NCT00716417|P1|Participant Flow|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492636|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492637|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492638|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492639|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492640|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492641|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492642|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492643|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492644|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492645|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492646|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492647|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492648|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492649|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492650|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492651|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492652|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492653|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492654|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492655|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492656|NCT00716417|O2|Outcome|5FU + Cis + Afatinib (Regimen B)|Patients received continous daily dosing with Afatinib film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil and Cisplatin on day 1 of each cycle in 5 dose levels as outlined in first primary endpoint.
492657|NCT00716417|O1|Outcome|Pac + Cis + Afatinib (Regimen A)|Patients received continous daily dosing with Afatinib film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel and Cisplatin on day 1 of each cycle in 5 dose levels as outlined in first primary endpoint.
492658|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492659|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492660|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492661|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492662|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492663|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492664|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492705|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492665|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492666|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492667|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492668|NCT00716417|E10|Reported Event|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492669|NCT00716417|E9|Reported Event|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492670|NCT00716417|E8|Reported Event|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492671|NCT00716417|E7|Reported Event|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492672|NCT00716417|E6|Reported Event|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492673|NCT00716417|E5|Reported Event|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492674|NCT00716417|E4|Reported Event|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492675|NCT00716417|E3|Reported Event|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492676|NCT00716417|E2|Reported Event|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492677|NCT00716417|E1|Reported Event|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
492678|NCT00716443|B1|Baseline|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
492679|NCT00716443|P1|Participant Flow|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
492680|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492681|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492682|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492683|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492684|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492685|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492686|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492687|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492688|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492689|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492690|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492691|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492692|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492693|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492694|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492695|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492696|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492697|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492698|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492699|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492700|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492701|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492702|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492706|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492707|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492708|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
492709|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
492710|NCT00716443|E1|Reported Event|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
492711|NCT00716456|B4|Baseline|Total|Total of all reporting groups
492712|NCT00716456|B3|Baseline|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
492713|NCT00716456|B2|Baseline|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
492714|NCT00716456|B1|Baseline|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
492715|NCT00716456|P3|Participant Flow|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
492716|NCT00716456|P2|Participant Flow|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
492717|NCT00716456|P1|Participant Flow|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
492718|NCT00716456|O3|Outcome|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
492719|NCT00716456|O2|Outcome|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
492762|NCT00716742|B1|Baseline|Lumigan®|bimatoprost 0.03%
492724|NCT00716482|B1|Baseline|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
492725|NCT00716482|P1|Participant Flow|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
492726|NCT00716482|O1|Outcome|Overall (All Masses)|Benign and malignant lesions
492727|NCT00716482|O1|Outcome|Overall (All Masses)|614 benign and 144 malignant masses
492728|NCT00716482|O3|Outcome|Not Homogeneous|"The Elastography image of the lesion is inhomogeneous and has a mottled or patchy appearance throughout."
492729|NCT00716482|O2|Outcome|Reasonably Homogeneous|"The Elastography image of the lesion has a slightly patchy appearance. The image may consist of larger (2-5mm) sub-regions within the lesion boundary that are homogenous, or the color differences between adjacent areas within the lesion are small."
492730|NCT00716482|O1|Outcome|Very Homogeneous|The Elastography image of the lesion has a smooth and consistent color appearance throughout, or very subtle color differences relating to small changes on the color scale are observed.
492731|NCT00716482|O2|Outcome|Sensitivity|Number of cancers with positive test results/total #number of cancers B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
492732|NCT00716482|O1|Outcome|Specificity|Number of benign lesions with negative test results/total number of benign lesions B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
492733|NCT00716482|E1|Reported Event|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
492734|NCT00716625|B1|Baseline|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492735|NCT00716625|P1|Participant Flow|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492736|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492737|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492738|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492739|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492740|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492741|NCT00716625|O3|Outcome|Without Concomitant CYP3A4 Inhibitors|Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert
492742|NCT00716625|O2|Outcome|With Concomitant CYP3A4 Inhibitors (During Treatment)|Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert
492743|NCT00716625|O1|Outcome|With Concomitant CYP3A4 Inhibitors (Start of Treatment)|Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert
492744|NCT00716625|O3|Outcome|Unknown|Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert
492745|NCT00716625|O2|Outcome|Without Renal Impairment|Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert
492746|NCT00716625|O1|Outcome|With Renal Impairment|Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert
492856|NCT00716963|O1|Outcome|Fluticasone Propionate (Flovent Diskus) 250 mcg|
492857|NCT00716963|O3|Outcome|Placebo|
492747|NCT00716625|O3|Outcome|Unknown|Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert
492748|NCT00716625|O2|Outcome|Without Hepatic Impairment|Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert
492749|NCT00716625|O1|Outcome|With Hepatic Impairment|Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert
492750|NCT00716625|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
492751|NCT00716625|O2|Outcome|Non-elderly|Participants aged ˂65 years who received sunitinib malate according to Japanese package insert
492752|NCT00716625|O1|Outcome|Elderly|Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert
492753|NCT00716625|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
492754|NCT00716625|O2|Outcome|Adult|Participants aged ˃=15 years who received sunitinib malate according to Japanese package insert
492755|NCT00716625|O1|Outcome|Pediatric|Participants aged ˂15 years who received sunitinib malate according to Japanese package insert
492756|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492757|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492758|NCT00716625|E1|Reported Event|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492773|NCT00716807|B4|Baseline|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
492774|NCT00716807|B3|Baseline|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
492775|NCT00716807|B2|Baseline|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
492776|NCT00716807|B1|Baseline|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
492777|NCT00716807|P4|Participant Flow|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
492778|NCT00716807|P3|Participant Flow|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
492779|NCT00716807|P2|Participant Flow|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
492780|NCT00716807|P1|Participant Flow|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
492781|NCT00716807|O4|Outcome|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
492782|NCT00716807|O3|Outcome|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
492783|NCT00716807|O2|Outcome|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
492784|NCT00716807|O1|Outcome|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
492785|NCT00716807|E4|Reported Event|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
492786|NCT00716807|E3|Reported Event|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
492787|NCT00716807|E2|Reported Event|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
492858|NCT00716963|O2|Outcome|Budesonide 400mcg|
492788|NCT00716807|E1|Reported Event|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
492789|NCT00716820|B1|Baseline|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492790|NCT00716820|P1|Participant Flow|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492791|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492792|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492793|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492794|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492795|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492796|NCT00716820|O3|Outcome|Without Concomitant CYP3A4 Inhibitors|Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert
492797|NCT00716820|O2|Outcome|With Concomitant CYP3A4 Inhibitors (During Treatment)|Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert
492798|NCT00716820|O1|Outcome|With Concomitant CYP3A4 Inhibitors (Start of Treatment)|Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert
492799|NCT00716820|O3|Outcome|Unknown|Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert
492800|NCT00716820|O2|Outcome|Without Renal Impairment|Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert
492801|NCT00716820|O1|Outcome|With Renal Impairment|Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert
492802|NCT00716820|O3|Outcome|Unknown|Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert
492803|NCT00716820|O2|Outcome|Without Hepatic Impairment|Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert
492804|NCT00716820|O1|Outcome|With Hepatic Impairment|Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert
492805|NCT00716820|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
492806|NCT00716820|O2|Outcome|Non-elderly|Participants aged ˂65 years who received sunitinib malate according to Japanese package insert
492807|NCT00716820|O1|Outcome|Elderly|Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert
492808|NCT00716820|O3|Outcome|Unknown|Participants with unknown PDGFRα mutation status who received sunitinib malate according to Japanese package insert
492809|NCT00716820|O2|Outcome|PDGFRα Without Mutation|Participants without PDGFRα mutation who received sunitinib malate according to Japanese package insert
492810|NCT00716820|O1|Outcome|PDGFRα With Mutation|Participants with PDGFRα mutation who received sunitinib malate according to Japanese package insert
492811|NCT00716820|O3|Outcome|Unknown|Participants with unknown c-kit mutation status who received sunitinib malate according to Japanese package insert
492812|NCT00716820|O2|Outcome|c-Kit Without Mutation|Participants without c-kit mutation who received sunitinib malate according to Japanese package insert
492813|NCT00716820|O1|Outcome|c-Kit With Mutation|Participants with c-kit mutation who received sunitinib malate according to Japanese package insert
492814|NCT00716820|O3|Outcome|Unknown|Participants with unknown KIT expression status who received sunitinib malate according to Japanese package insert
492815|NCT00716820|O2|Outcome|KIT Negative|Participants with negative KIT expression who received sunitinib malate according to Japanese package insert
492816|NCT00716820|O1|Outcome|KIT Positive|Participants with positive KIT expression who received sunitinib malate according to Japanese package insert
492817|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492818|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492819|NCT00716820|E1|Reported Event|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
492820|NCT00716859|B3|Baseline|Total|Total of all reporting groups
492821|NCT00716859|B2|Baseline|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492822|NCT00716859|B1|Baseline|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492823|NCT00716859|P2|Participant Flow|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492824|NCT00716859|P1|Participant Flow|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492825|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492826|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492827|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492828|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492829|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492830|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492831|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492832|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492833|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492834|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492835|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492836|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492837|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492838|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492839|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492890|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
492840|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492841|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492842|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492843|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492844|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492845|NCT00716859|E2|Reported Event|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
492846|NCT00716859|E1|Reported Event|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
492847|NCT00716963|B1|Baseline|Screening/Baseline Participants|
492848|NCT00716963|P6|Participant Flow|Placebo/Budesonide/Fluticasone|Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
492849|NCT00716963|P5|Participant Flow|Placebo/Fluticasone/Budesonide|Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
492850|NCT00716963|P4|Participant Flow|Budesonide/Placebo/Fluticasone|Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
492851|NCT00716963|P3|Participant Flow|Budesonide/Fluticasone/Placebo|Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
492852|NCT00716963|P2|Participant Flow|Fluticasone/Placebo/Budesonide|Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
492853|NCT00716963|P1|Participant Flow|Fluticasone/Budesonide/Placebo|Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
492854|NCT00716963|O3|Outcome|Placebo|
492855|NCT00716963|O2|Outcome|Budesonide 400mcg|
492859|NCT00716963|O1|Outcome|Fluticasone Propionate (Flovent Diskus) 250 mcg|
492860|NCT00716963|E3|Reported Event|Placebo|
492861|NCT00716963|E2|Reported Event|Budesonide 400mcg|
492862|NCT00716963|E1|Reported Event|Fluticasone Propionate (Flovent Diskus) 250 mcg|
492863|NCT00716976|B3|Baseline|Total|Total of all reporting groups
492864|NCT00716976|B2|Baseline|Observation Arm|No sodium thiosulfate treatment.
492865|NCT00716976|B1|Baseline|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
492866|NCT00716976|P2|Participant Flow|Observation Arm|No sodium thiosulfate treatment.
492867|NCT00716976|P1|Participant Flow|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
492868|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
492869|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
492870|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
492871|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
492872|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
492873|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
492874|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
492875|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
492876|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
492877|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
492878|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
492879|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
492880|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
492881|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
492882|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
492883|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
492884|NCT00716976|E2|Reported Event|Observation Arm|
492885|NCT00716976|E1|Reported Event|STS Arm (Sodium Thiosulfate Treatment)|
492886|NCT00717041|B1|Baseline|Presenting to the ED|Patients who present to the ED
492887|NCT00717041|P1|Participant Flow|Presenting to the ED|Patients who present to the ED
492888|NCT00717041|O2|Outcome|Cognitively Impaired in the ED|Patients presenting to the ED who have cognitive impairment
492889|NCT00717041|O1|Outcome|Depressed in the ED|Patients who present to the ED who test positive for depression
492891|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
492892|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
492893|NCT00717041|E1|Reported Event|Presenting to the ED|Patients who present to the ED
492894|NCT00717054|B3|Baseline|Total|Total of all reporting groups
492895|NCT00717054|B2|Baseline|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.
Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492896|NCT00717054|B1|Baseline|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.
Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492897|NCT00717054|P2|Participant Flow|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.
Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492898|NCT00717054|P1|Participant Flow|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.
Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492899|NCT00717054|O2|Outcome|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.
Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492900|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.
Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492926|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
492901|NCT00717054|O2|Outcome|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.
Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492902|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.
Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492903|NCT00717054|O2|Outcome|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.
Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492904|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.
Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492905|NCT00717054|O2|Outcome|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.
Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492945|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492946|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
512607|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
492906|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.
Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492907|NCT00717054|E2|Reported Event|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.
Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492908|NCT00717054|E1|Reported Event|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.
Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
492909|NCT00717067|B6|Baseline|Total|Total of all reporting groups
492910|NCT00717067|B5|Baseline|ESRD on Hemodialysis|Subjects with End Stage Renal Disease Requiring Regular Hemodialysis 3 Times a Week for at Least 6 Weeks Prior to Screening (Creatinine Clearance <30 mL/min)
492911|NCT00717067|B4|Baseline|Severe Renal Impairment|Subjects with Severe Renal Impairment (Creatinine Clearance <30 mL/min)
492912|NCT00717067|B3|Baseline|Moderate Renal Impairment|Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)
492913|NCT00717067|B2|Baseline|Mild Renal Impairment|Subjects with Mild Renal Impairment (Creatinine Clearance >50 and ≤80 mL/min)
492914|NCT00717067|B1|Baseline|Healthy Subjects|Subjects with Normal Renal Function (Creatinine Clearance > 80mL/min)
492915|NCT00717067|P5|Participant Flow|ESRD: Single Dose|(I) Maraviroc single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc single dose three hours prior to start of hemodialysis.
492916|NCT00717067|P4|Participant Flow|Severe Renal Impairment|Maraviroc 300 mg single dose.
492917|NCT00717067|P3|Participant Flow|Moderate Renal Impairment|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492918|NCT00717067|P2|Participant Flow|Mild Renal Impairment|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492919|NCT00717067|P1|Participant Flow|Healthy Subjects|(I) Maraviroc single 300 mg dose, followed 4 days later by (II) Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
492920|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
492921|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
492922|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
492923|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492924|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492925|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492927|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
492928|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
492929|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
492930|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492931|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492932|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492933|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
492934|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
492935|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
492936|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
492937|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492938|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492939|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492940|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
492941|NCT00717067|O1|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis
492942|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
492943|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492944|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492947|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
492948|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492949|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492950|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492951|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
492952|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
492953|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
492954|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
492955|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492956|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492957|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492958|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
492959|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
492960|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
492961|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
492962|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492963|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492964|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492965|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
492966|NCT00717067|O4|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
492967|NCT00717067|O3|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
492968|NCT00717067|O2|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
492969|NCT00717067|O1|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492970|NCT00717067|O6|Outcome|ESRD|(I) Maraviroc 300 mg single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
492971|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
492972|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492973|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492974|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492975|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
492976|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
492977|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
492978|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
492979|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492980|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492981|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492982|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
492983|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492984|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492985|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
492986|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
492987|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
492988|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
492989|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492990|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492991|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492992|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
492993|NCT00717067|E7|Reported Event|ESRD: Dosing Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
492994|NCT00717067|E6|Reported Event|ESRD: Dosing After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
492995|NCT00717067|E5|Reported Event|Severe Renal Impairment:|Maraviroc 300 mg single dose.
492996|NCT00717067|E4|Reported Event|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
492997|NCT00717067|E3|Reported Event|Moderate Renal Impairment|Maraviroc 150 milligrams (mg) every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492998|NCT00717067|E2|Reported Event|Mild Renal Impairment|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
492999|NCT00717067|E1|Reported Event|Healthy Subjects|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
493000|NCT00717093|B3|Baseline|Total|Total of all reporting groups
493001|NCT00717093|B2|Baseline|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493002|NCT00717093|B1|Baseline|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493003|NCT00717093|P2|Participant Flow|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493004|NCT00717093|P1|Participant Flow|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493005|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493006|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493007|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493008|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
498781|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
493009|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493010|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493011|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493012|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493013|NCT00717093|E2|Reported Event|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493014|NCT00717093|E1|Reported Event|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
493015|NCT00717197|B1|Baseline|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
493016|NCT00717197|P1|Participant Flow|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
493017|NCT00717197|O1|Outcome|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
493018|NCT00717197|E1|Reported Event|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
493019|NCT00717236|B3|Baseline|Total|Total of all reporting groups
493020|NCT00717236|B2|Baseline|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493186|NCT00717574|B1|Baseline|Sevoflurane Group|"Sevoflurane based general anesthesia
Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
493021|NCT00717236|B1|Baseline|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493022|NCT00717236|P2|Participant Flow|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493023|NCT00717236|P1|Participant Flow|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493024|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493025|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493026|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493027|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493028|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493029|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493030|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493031|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493032|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493033|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493034|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493035|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493036|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493037|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493038|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493039|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493040|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493041|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493042|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493043|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493044|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493045|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493088|NCT00717236|E3|Reported Event|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493046|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493047|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493048|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493049|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493050|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493051|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493052|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493053|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493054|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493055|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493056|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493057|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493058|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493059|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493060|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493061|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493062|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493063|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493064|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493065|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493066|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493067|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493068|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493069|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493070|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493071|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493072|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493073|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493074|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493075|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493076|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493077|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493078|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493079|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493080|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493081|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493082|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493083|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493084|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493085|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493086|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493087|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
493089|NCT00717236|E2|Reported Event|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg certolizumab pegol (CZP) given as 1 subcutaneous injection every other week for a minimum 16 additional weeks until CZP is commercially available.
493090|NCT00717236|E1|Reported Event|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
493091|NCT00717249|B3|Baseline|Total|Total of all reporting groups
493092|NCT00717249|B2|Baseline|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
493093|NCT00717249|B1|Baseline|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
493094|NCT00717249|P2|Participant Flow|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
493095|NCT00717249|P1|Participant Flow|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
493096|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
493097|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
493098|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
493099|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
493100|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
493101|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
493102|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
493103|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
493104|NCT00717249|E2|Reported Event|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
493105|NCT00717249|E1|Reported Event|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
493106|NCT00717275|B1|Baseline|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
493107|NCT00717275|P1|Participant Flow|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
493108|NCT00717275|O1|Outcome|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
493109|NCT00717275|E1|Reported Event|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
493110|NCT00717288|B4|Baseline|Total|Total of all reporting groups
493111|NCT00717288|B3|Baseline|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
493112|NCT00717288|B2|Baseline|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
493113|NCT00717288|B1|Baseline|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
493114|NCT00717288|P3|Participant Flow|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
493115|NCT00717288|P2|Participant Flow|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
493116|NCT00717288|P1|Participant Flow|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
493117|NCT00717288|O3|Outcome|80% Conversion Factor|Number of subjects that reverted back to an insulin drip
493118|NCT00717288|O2|Outcome|65% Conversion Factor|Number of subjects that reverted back to an insulin drip
493119|NCT00717288|O1|Outcome|50% Conversion Factor|Number of subjects that reverted back to an insulin drip
493120|NCT00717288|O3|Outcome|80% Conversion Factor|Number of subjects with a BG value <65 mg/dl
493121|NCT00717288|O2|Outcome|65% Conversion Factor|Number of subjects with a BG value <65 mg/dl
493122|NCT00717288|O1|Outcome|50% Conversion Factor|Number of subjects with a BG value <65 mg/dl
493123|NCT00717288|O3|Outcome|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
493124|NCT00717288|O2|Outcome|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
493125|NCT00717288|O1|Outcome|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
493126|NCT00717288|E3|Reported Event|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
493127|NCT00717288|E2|Reported Event|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
493128|NCT00717288|E1|Reported Event|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
493129|NCT00717314|B3|Baseline|Total|Total of all reporting groups
493130|NCT00717314|B2|Baseline|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493131|NCT00717314|B1|Baseline|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493132|NCT00717314|P2|Participant Flow|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493133|NCT00717314|P1|Participant Flow|Mycophenolate Mofetil (MMF), 50% Calcineurin Inhibitor (CNI)|Participants received MMF capsules, 1.5 to 2.0 grams (g), orally (PO), twice daily (BID) up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50 percent (%) through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493134|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493135|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493136|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493137|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493377|NCT00711477|O2|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493138|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493139|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493140|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493141|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493142|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493185|NCT00717574|B2|Baseline|Propofol Group|"Propofol based general anesthesia
Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
493143|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493144|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493145|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493146|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493147|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493148|NCT00717314|E2|Reported Event|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493149|NCT00717314|E1|Reported Event|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
493206|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493207|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493150|NCT00717405|B1|Baseline|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493151|NCT00717405|P1|Participant Flow|Bevacizumab + Trastuzumab Chemotherapy|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 milligrams per kilogram (mg/kg) intravenous (IV) bevacizumab every 3 weeks (q3w) for 8 cycles, 4 cycles of 500 milligrams per squared-meter (mg/m^2) IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493152|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
512858|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
493153|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493154|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493155|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493156|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493157|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
494358|NCT00720096|B2|Baseline|Topotecan|Topotecan - Chemotherapy single agent systemic.
493158|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493159|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493160|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493540|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
493161|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493162|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493163|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493164|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493165|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493208|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493166|NCT00717405|E1|Reported Event|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
493167|NCT00717418|B5|Baseline|Total|Total of all reporting groups
493168|NCT00717418|B4|Baseline|Missing Treatment Information|
493169|NCT00717418|B3|Baseline|Combination Treatments|
493170|NCT00717418|B2|Baseline|Artificial Tears Alone|
493171|NCT00717418|B1|Baseline|Restasis® Alone|cyclosporine ophthalmic emulsion 0.05%
493172|NCT00717418|P4|Participant Flow|Missing Treatment Information|
493173|NCT00717418|P3|Participant Flow|Combination Treatments|
493174|NCT00717418|P2|Participant Flow|Artificial Tears Alone|
493175|NCT00717418|P1|Participant Flow|Restasis® Alone|cyclosporine ophthalmic emulsion 0.05%
493176|NCT00717418|O1|Outcome|All Patients|
493177|NCT00717418|O1|Outcome|All Patients|
493178|NCT00717418|E1|Reported Event|All Patients|
493179|NCT00717522|B1|Baseline|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
493180|NCT00717522|P1|Participant Flow|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
493181|NCT00717522|O1|Outcome|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
493182|NCT00717522|O1|Outcome|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
493183|NCT00717522|E1|Reported Event|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
493184|NCT00717574|B3|Baseline|Total|Total of all reporting groups
493187|NCT00717574|P2|Participant Flow|Propofol Group|"Propofol based general anesthesia
Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
493188|NCT00717574|P1|Participant Flow|Sevoflurane Group|"Sevoflurane based general anesthesia
Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
493189|NCT00717574|O2|Outcome|Propofol Group|"Propofol based general anesthesia
Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
493190|NCT00717574|O1|Outcome|Sevoflurane Group|"Sevoflurane based general anesthesia
Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
493191|NCT00717574|E2|Reported Event|Propofol Group|"Propofol based general anesthesia
Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
493192|NCT00717574|E1|Reported Event|Sevoflurane Group|"Sevoflurane based general anesthesia
Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
493193|NCT00717756|B1|Baseline|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
493194|NCT00717756|P1|Participant Flow|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
493195|NCT00717756|O1|Outcome|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
493196|NCT00717756|E1|Reported Event|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
493197|NCT00705614|B3|Baseline|Total|Total of all reporting groups
493198|NCT00705614|B2|Baseline|Standard Therapy Group|The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up.
493199|NCT00705614|B1|Baseline|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
493200|NCT00705614|P2|Participant Flow|Standard Therapy Group|"Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Some participants who start in the Standard Therapy Group switched over to Remicade sometime during the follow-up period. Participants who switched to Remicade were evaluated in the Standard Therapy group until the time of the switch and were evaluated in the Switched to Remicade group thereafter."
493201|NCT00705614|P1|Participant Flow|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
493202|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493203|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493204|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493205|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493287|NCT00711191|B4|Baseline|Total|Total of all reporting groups
493209|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493210|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493211|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493212|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493213|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493214|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493215|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493216|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493217|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493218|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493219|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493220|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493221|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493222|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493223|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493224|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493225|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493226|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493227|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493228|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493229|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493230|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493231|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493232|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493233|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493234|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493235|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493236|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493237|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493238|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493239|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493240|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493241|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
498782|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
493242|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493243|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493244|NCT00705614|E3|Reported Event|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
493245|NCT00705614|E2|Reported Event|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
493246|NCT00705614|E1|Reported Event|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
493247|NCT00705653|B1|Baseline|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
493248|NCT00705653|P1|Participant Flow|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
493249|NCT00705653|O1|Outcome|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
493250|NCT00705653|O1|Outcome|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
493251|NCT00705653|E1|Reported Event|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
493252|NCT00705666|B1|Baseline|PegIntron as Monotherapy or in Combination With Ribavirin|Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
493253|NCT00705666|P1|Participant Flow|PegIntron as Monotherapy or in Combination With Ribavirin|Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
493292|NCT00711191|P2|Participant Flow|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
493254|NCT00705666|O1|Outcome|PegIntron as Monotherapy or in Combination With Ribavirin|"Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
The recommended treatment duration was 24 weeks for genotypes 2 and 3 and 48 weeks for genotype 1 according to the French 2002 consensus meeting.
The start and end dates of the treatment were collected in the questionnaire, so the actual treatment duration was calculated for each participant and compared to the theoretical treatment duration reported at Day 0 by the investigators."
493255|NCT00705666|E1|Reported Event|PegIntron as Monotherapy or in Combination With Ribavirin|
493256|NCT00711087|B3|Baseline|Total|Total of all reporting groups
493257|NCT00711087|B2|Baseline|ARM 1|Subjects randomized to receive 100 units of BOTOX-A injections on Days 0 and 90.
493258|NCT00711087|B1|Baseline|ARM 2|Subjects randomized to receive placebo (saline) sham saline injections on Days 0 and 90.
493259|NCT00711087|P2|Participant Flow|ARM 1|Patients in ARM 1 randomized to receive 100 units of BOTOX-A on Day 0 and Day 90
493260|NCT00711087|P1|Participant Flow|ARM 2|Patients in ARM 2 randomized to receive placebo (saline) injections on Days 0 and 90.
493261|NCT00711087|O2|Outcome|ARM 1|Subjects randomized to receive 100 units of BOTOX-A on Days 0 and 90
493262|NCT00711087|O1|Outcome|ARM 2|Subjects randomized to receive placebo (saline) sham saline injections on Days 0 and 90.
493263|NCT00711087|E2|Reported Event|ARM 1|"Receiving BOTOX-A
BOTOX-A: Group 1-100 units of BTX-A (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90"
493264|NCT00711087|E1|Reported Event|ARM 2|"Receiving placebo (saline injections)
Saline injection: Group 2-sham saline injections on both Day 0 and Day 90."
493265|NCT00711100|B1|Baseline|Oral Tobacco Products|Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
493266|NCT00711100|P1|Participant Flow|Oral Tobacco Products|Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
493267|NCT00711100|O4|Outcome|Ariva|Number of participants who preferred this product during abstinence phase
493268|NCT00711100|O3|Outcome|Stonewall|Number of participants who preferred this product during abstinence phase
493269|NCT00711100|O2|Outcome|Marlboro Snus|Number of participants who preferred this product during abstinence phase
493270|NCT00711100|O1|Outcome|Camel Snus|Number of participants who preferred this product during abstinence phase
493271|NCT00711100|O5|Outcome|General Snus|Number of partiicipants who sampled General Snus
493272|NCT00711100|O4|Outcome|Ariva|Number of participants who sampled Ariva
493273|NCT00711100|O3|Outcome|Stonewall|Number of participants who sampled Stonewall
493274|NCT00711100|O2|Outcome|Marlboro Snus|Number of participants who sampled Marlboro Snus
493275|NCT00711100|O1|Outcome|Camel Snus|Number of participants who sampled Camel Snus
493276|NCT00711100|E5|Reported Event|General Snus|Participants who sampled General Snus
493277|NCT00711100|E4|Reported Event|Ariva|Participants who sampled Ariva
493278|NCT00711100|E3|Reported Event|Stonewall|Participants who sampled Stonewall
493279|NCT00711100|E2|Reported Event|Marlboro Snus|Participants who sampled Marlboro Snus
493280|NCT00711100|E1|Reported Event|Camel Snus|Participant who sampled Camel Snus
493281|NCT00711113|B1|Baseline|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493282|NCT00711113|P1|Participant Flow|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493283|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493284|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493285|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493286|NCT00711113|E1|Reported Event|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493288|NCT00711191|B3|Baseline|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493289|NCT00711191|B2|Baseline|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
493290|NCT00711191|B1|Baseline|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493291|NCT00711191|P3|Participant Flow|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493293|NCT00711191|P1|Participant Flow|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493294|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|"Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles."
493295|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493296|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
493297|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493298|NCT00711191|O1|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493299|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493300|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
493301|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493302|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493303|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
493304|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493305|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493306|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
513080|NCT00761007|B3|Baseline|Ibodutant 60 mg|oral tablet, once daily
493307|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493308|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493309|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
493310|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493311|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493312|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
493313|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493314|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493375|NCT00711477|O2|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493315|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
493316|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493317|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493318|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493344|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
493345|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
493346|NCT00711347|E2|Reported Event|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
493347|NCT00711347|E1|Reported Event|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
493319|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493320|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493321|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
493322|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493323|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493324|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
493325|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493326|NCT00711191|E3|Reported Event|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
493376|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493327|NCT00711191|E2|Reported Event|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
493328|NCT00711191|E1|Reported Event|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
493329|NCT00711347|B3|Baseline|Total|Total of all reporting groups
493330|NCT00711347|B2|Baseline|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
493331|NCT00711347|B1|Baseline|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
493332|NCT00711347|P2|Participant Flow|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
493333|NCT00711347|P1|Participant Flow|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
493334|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
493335|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
493336|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
493337|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
493338|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
493339|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
493340|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
493341|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
493342|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
493343|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
493348|NCT00711425|B1|Baseline|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493349|NCT00711425|P1|Participant Flow|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493350|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493351|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493352|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493353|NCT00711425|E1|Reported Event|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
493354|NCT00711477|B3|Baseline|Total|Total of all reporting groups
493355|NCT00711477|B2|Baseline|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493356|NCT00711477|B1|Baseline|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493357|NCT00711477|P2|Participant Flow|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493358|NCT00711477|P1|Participant Flow|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493359|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493360|NCT00711477|O1|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493361|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493362|NCT00711477|O1|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493363|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493364|NCT00711477|O1|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493365|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493366|NCT00711477|O1|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493367|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493368|NCT00711477|O1|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493369|NCT00711477|O2|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493370|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493371|NCT00711477|O2|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493372|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493373|NCT00711477|O2|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493374|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493378|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493379|NCT00711477|O2|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493380|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493381|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493382|NCT00711477|O1|Outcome|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493383|NCT00711477|E2|Reported Event|Placebo|"Placebo tablets
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493384|NCT00711477|E1|Reported Event|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
493385|NCT00711490|B1|Baseline|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
493386|NCT00711490|P1|Participant Flow|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
493387|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
493388|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
493389|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
493390|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
493391|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
493392|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
493393|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
493394|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
493496|NCT00711529|P2|Participant Flow|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493727|NCT00717912|O1|Outcome|Classical Sugar Syrup|The subjects consumed three times this product
493395|NCT00711490|E1|Reported Event|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
493396|NCT00711516|B3|Baseline|Total|Total of all reporting groups
493397|NCT00711516|B2|Baseline|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
493398|NCT00711516|B1|Baseline|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
493399|NCT00711516|P2|Participant Flow|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
493400|NCT00711516|P1|Participant Flow|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
493401|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493402|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493403|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493404|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493405|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493406|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493407|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493573|NCT00711646|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493408|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493409|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493410|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493411|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493412|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493413|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493414|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493537|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493538|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493415|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493416|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493417|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493418|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493419|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493420|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493421|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493422|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493423|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493424|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493425|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493426|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493427|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493574|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
494907|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
493428|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493429|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493430|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493431|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493432|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493433|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493434|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493435|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493436|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493437|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493438|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493439|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493440|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493441|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493442|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493443|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493444|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493445|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493446|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493447|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493575|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493448|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493449|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493450|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493451|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493452|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493453|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493454|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493455|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493456|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493457|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493458|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493459|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493460|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493461|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493462|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493463|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493464|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493465|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493466|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493467|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493576|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
494908|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
493468|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493469|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493470|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493471|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493472|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493473|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493474|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493475|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493476|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493477|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493478|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493479|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493480|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493481|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493482|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493483|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493484|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493485|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493486|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493487|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493577|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493488|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493489|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493490|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
493491|NCT00711516|E2|Reported Event|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
493492|NCT00711516|E1|Reported Event|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
493493|NCT00711529|B3|Baseline|Total|Total of all reporting groups
493494|NCT00711529|B2|Baseline|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493495|NCT00711529|B1|Baseline|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493539|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
493497|NCT00711529|P1|Participant Flow|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493498|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493499|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493500|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493501|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493502|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493503|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493504|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493505|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493506|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493507|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493508|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493509|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493510|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493511|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493512|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493513|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493514|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493515|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493516|NCT00711529|E2|Reported Event|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
493517|NCT00711529|E1|Reported Event|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
493518|NCT00711555|B1|Baseline|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
493519|NCT00711555|P1|Participant Flow|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
493520|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
493521|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
493522|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
493523|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
493524|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
493525|NCT00711594|B5|Baseline|Total|Total of all reporting groups
493526|NCT00711594|B4|Baseline|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493527|NCT00711594|B3|Baseline|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493528|NCT00711594|B2|Baseline|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
493529|NCT00711594|B1|Baseline|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
493530|NCT00711594|P4|Participant Flow|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493531|NCT00711594|P3|Participant Flow|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493532|NCT00711594|P2|Participant Flow|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
493533|NCT00711594|P1|Participant Flow|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
493534|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493535|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
493536|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
493541|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493542|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
493543|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
493544|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493545|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
493546|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
493547|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493548|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493549|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493550|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493551|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493552|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493553|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
493554|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
493555|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493556|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493557|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493558|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493559|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
493560|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
493561|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493562|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493563|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
493564|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
493565|NCT00711594|E4|Reported Event|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493566|NCT00711594|E3|Reported Event|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
493567|NCT00711594|E2|Reported Event|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
493568|NCT00711594|E1|Reported Event|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
493569|NCT00711646|B3|Baseline|Total|Total of all reporting groups
493570|NCT00711646|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493571|NCT00711646|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493572|NCT00711646|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493578|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493579|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493580|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493581|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493582|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493583|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493584|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493585|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493586|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493587|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493588|NCT00711646|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493589|NCT00711646|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493590|NCT00711802|B9|Baseline|Total|Total of all reporting groups
493591|NCT00711802|B8|Baseline|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to <2 years"
493728|NCT00717912|O3|Outcome|Classical Sweetener Syrup|The subjects consumed once this product
493592|NCT00711802|B7|Baseline|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to <2 years"
493593|NCT00711802|B6|Baseline|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years"
493594|NCT00711802|B5|Baseline|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years"
493595|NCT00711802|B4|Baseline|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years"
493596|NCT00711802|B3|Baseline|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years"
493597|NCT00711802|B2|Baseline|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years"
493598|NCT00711802|B1|Baseline|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years"
493599|NCT00711802|P8|Participant Flow|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to <2 years"
493600|NCT00711802|P7|Participant Flow|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to <2 years"
493601|NCT00711802|P6|Participant Flow|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years"
493602|NCT00711802|P5|Participant Flow|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years"
493603|NCT00711802|P4|Participant Flow|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years"
493604|NCT00711802|P3|Participant Flow|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years"
493605|NCT00711802|P2|Participant Flow|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years"
493606|NCT00711802|P1|Participant Flow|Age Group 1: Daptomycin|"Daptomycin: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years"
493607|NCT00711802|O4|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to <2 years"
493608|NCT00711802|O3|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years"
494909|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
493609|NCT00711802|O2|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years"
493610|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years"
493611|NCT00711802|O8|Outcome|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to <2 years"
493612|NCT00711802|O7|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to <2 years"
493613|NCT00711802|O6|Outcome|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years"
493614|NCT00711802|O5|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years"
493615|NCT00711802|O4|Outcome|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years"
493616|NCT00711802|O3|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years"
493617|NCT00711802|O2|Outcome|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years"
493618|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years"
493619|NCT00711802|O8|Outcome|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to <2 years"
493620|NCT00711802|O7|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to <2 years"
513081|NCT00761007|B2|Baseline|Ibodutant 30 mg|oral tablet, once daily
493621|NCT00711802|O6|Outcome|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years"
493622|NCT00711802|O5|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years"
493623|NCT00711802|O4|Outcome|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years"
493624|NCT00711802|O3|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years"
493625|NCT00711802|O2|Outcome|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years"
493626|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years"
493627|NCT00711802|E8|Reported Event|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 4: Participants ages 1 to <2 years"
493628|NCT00711802|E7|Reported Event|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days
Age Group 4: Participants ages 1 to <2 years"
493629|NCT00711802|E6|Reported Event|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 3: Participants ages 2 to 6 years"
493630|NCT00711802|E5|Reported Event|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days
Age Group 3: Participants ages 2 to 6 years"
493631|NCT00711802|E4|Reported Event|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 2: Participants ages 7 to 11 years"
493632|NCT00711802|E3|Reported Event|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days
Age Group 2: Participants ages 7 to 11 years"
493633|NCT00711802|E2|Reported Event|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years"
493634|NCT00711802|E1|Reported Event|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days
Age Group 1: Participants ages 12 to 17 years"
493635|NCT00711828|B1|Baseline|Treatment|Rituximab 375 mg/m2 IV on day 1 > Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 > Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 > Dexamethasone 40 mg PO on days 1, 8, 15, 22
493636|NCT00711828|P1|Participant Flow|Treatment|Rituximab 375 mg/m2 IV on day 1 > Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 > Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 > Dexamethasone 40 mg PO on days 1, 8, 15, 22
493637|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1
> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22
> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22
> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
494910|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
493638|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1
> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22
> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22
> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
493639|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1
> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22
> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22
> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
493640|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1
> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22
> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22
> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
493641|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1
> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22
> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22
> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
493642|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1
> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22
> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22
> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
493643|NCT00711828|E1|Reported Event|Treatment|Dexamethasone 40 mg PO on days 1, 8, 15, 22
493644|NCT00711867|B3|Baseline|Total|Total of all reporting groups
493645|NCT00711867|B2|Baseline|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
493646|NCT00711867|B1|Baseline|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
493647|NCT00711867|P2|Participant Flow|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
493648|NCT00711867|P1|Participant Flow|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
493649|NCT00711867|O2|Outcome|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
493650|NCT00711867|O1|Outcome|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
493651|NCT00711867|E2|Reported Event|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
493652|NCT00711867|E1|Reported Event|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
493653|NCT00711880|B3|Baseline|Total|Total of all reporting groups
493654|NCT00711880|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493655|NCT00711880|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493656|NCT00711880|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493657|NCT00711880|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493658|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493659|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493660|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493661|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493662|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493663|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493664|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493665|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493666|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493667|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493668|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493669|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493670|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493671|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493672|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493673|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493674|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493675|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493676|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493677|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493678|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
498783|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
493679|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493680|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493681|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493682|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493683|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493684|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493685|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493686|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493687|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493688|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493689|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493690|NCT00711880|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
493691|NCT00711880|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
493692|NCT00717860|B3|Baseline|Total|Total of all reporting groups
493693|NCT00717860|B2|Baseline|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
513082|NCT00761007|B1|Baseline|Ibodutant 10 mg|oral tablet, once daily
493694|NCT00717860|B1|Baseline|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
493695|NCT00717860|P2|Participant Flow|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
493696|NCT00717860|P1|Participant Flow|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
493697|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
493698|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
493699|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
493700|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
493701|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
493702|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
493703|NCT00717860|E2|Reported Event|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
493704|NCT00717860|E1|Reported Event|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
493705|NCT00717873|B3|Baseline|Total|Total of all reporting groups
493706|NCT00717873|B2|Baseline|CPT Arm|Airway clearance provided by manual CPT
493707|NCT00717873|B1|Baseline|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
493708|NCT00717873|P2|Participant Flow|CPT Arm|Airway clearance provided by manual CPT
493709|NCT00717873|P1|Participant Flow|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
493710|NCT00717873|O2|Outcome|CPT Arm|Airway clearance provided by manual CPT
493711|NCT00717873|O1|Outcome|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
493712|NCT00717873|E2|Reported Event|CPT Arm|Airway clearance provided by manual CPT
493713|NCT00717873|E1|Reported Event|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
493714|NCT00717886|B1|Baseline|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
493715|NCT00717886|P1|Participant Flow|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
493716|NCT00717886|O1|Outcome|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
493717|NCT00717886|E1|Reported Event|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
493718|NCT00717912|B1|Baseline|All Participants|Each subject received the study products in different order according to the randomization list
493719|NCT00717912|P6|Participant Flow|Arm 6|Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup
493720|NCT00717912|P5|Participant Flow|Arm 5|Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup
493721|NCT00717912|P4|Participant Flow|Arm 4|Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup
493722|NCT00717912|P3|Participant Flow|Arm 3|Experimental sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup / Experimental sweetener syrup
493723|NCT00717912|P2|Participant Flow|Arm 2|Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup
493724|NCT00717912|P1|Participant Flow|Arm 1|Classical sugar syrup/ Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup
493725|NCT00717912|O3|Outcome|Classical Sweetener Syrup|The subjects consumed once this product
493726|NCT00717912|O2|Outcome|Experimental Sweetener Syrup|The subjects consumed three times this product
493729|NCT00717912|O2|Outcome|Experimental Sweetener Syrup|The subjects consumed three times this product
493730|NCT00717912|O1|Outcome|Classical Sugar Syrup|The subjects consumed three time this product
493731|NCT00717912|E3|Reported Event|Classical Sweetener Syrup|The subjects consumed once this product
493732|NCT00717912|E2|Reported Event|Experimental Sweetener Syrup|The subjects consumed three times this product
493733|NCT00717912|E1|Reported Event|Classical Sugar Syrup|The subjects consumed three times this product
493734|NCT00717977|B1|Baseline|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493735|NCT00717977|P1|Participant Flow|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493736|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493737|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493738|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493739|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493740|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493741|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493742|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493743|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493744|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493745|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493746|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493747|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493748|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493749|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493750|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493751|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493752|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493753|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493754|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493755|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493756|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493757|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493758|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493759|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493760|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493761|NCT00717977|E1|Reported Event|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
493762|NCT00718042|B7|Baseline|Total|Total of all reporting groups
493763|NCT00718042|B6|Baseline|Chagas Extended Evaluation|All subject's blood tested by the investigational Chagas screening test.
493764|NCT00718042|B5|Baseline|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas.
493765|NCT00718042|B4|Baseline|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
493766|NCT00718042|B3|Baseline|Reactivity in Chagas Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
493767|NCT00718042|B2|Baseline|Reactivity T Cruzi Antibody Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols and unidentified US blood donor specimens (202) were tested with investigational Chagas screening assay and with the Chagas confirmatory assay.
493768|NCT00718042|B1|Baseline|ABBOTT PRISM Chagas Specificity|All subject's blood tested by the investigational Chagas screening test.
493769|NCT00718042|P6|Participant Flow|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
493770|NCT00718042|P5|Participant Flow|Chagas Extended Evaluation|US blood donor specimen were tested with investigational Chagas screening assay to identify repeatedly reactive specimens.
493771|NCT00718042|P4|Participant Flow|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas.
493772|NCT00718042|P3|Participant Flow|Reactivity in Chagas Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
493773|NCT00718042|P2|Participant Flow|Reactivity T Cruzi Antibody Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols and unidentified US blood donor specimens (202) were tested with investigational Chagas screening assay and with the Chagas confirmatory assay.
493774|NCT00718042|P1|Participant Flow|ABBOTT PRISM Chagas Specificity|All blood donor specimens tested by the investigational Chagas screening test in design validation phase.
493775|NCT00718042|O1|Outcome|Reactivity in Chagas Endemic Population|Specimen from Chagas endemic area in South or Central America (524) under separate specimen collection protocol were tested with investigational ESA Chagas.
493776|NCT00718042|O1|Outcome|ESA Chagas Non-US Serologically Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols.
493777|NCT00718042|O1|Outcome|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South or Central America under separate specimen collection protocols were tested with investigational with ESA Chagas.
493778|NCT00718042|O1|Outcome|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
493779|NCT00718042|O1|Outcome|ESA Chagas US Donor Specimen Testing|A total of 58 PRISM Chagas repeatedly reactive US blood donor specimens tested with both ESA Chagas and RIPA.
494169|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
493780|NCT00718042|O1|Outcome|PRISM Chagas Reactivity Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
493781|NCT00718042|O1|Outcome|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay.
493782|NCT00718042|O1|Outcome|Reactivity T Cruzi Antibody Positive|Specimen positive for T cruzi antibody collected in South America (85) under separate specimen collection protocol and unidentified US blood donor specimens repeatedly reactive by T cruzi antibody licensed screening assay (202) were tested with investigational PRISM Chagas screening assay.
493783|NCT00718042|O1|Outcome|ABBOTT PRISM Chagas Specificity|Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
493784|NCT00718042|E1|Reported Event|Donor Follow-up Specimen Collection|Blood donors
493785|NCT00718081|B4|Baseline|Total|Total of all reporting groups
493786|NCT00718081|B3|Baseline|Placebo NanoTab|
493787|NCT00718081|B2|Baseline|Sufentanil NanoTab 15 mcg|
493788|NCT00718081|B1|Baseline|Sufentanil NanoTab 10 mcg|
493789|NCT00718081|P3|Participant Flow|Placebo NanoTab|
493790|NCT00718081|P2|Participant Flow|Sufentanil NanoTab 15 mcg|
493791|NCT00718081|P1|Participant Flow|Sufentanil NanoTab 10 mcg|
493792|NCT00718081|O3|Outcome|Placebo NanoTab|
493793|NCT00718081|O2|Outcome|Sufentanil NanoTab 15 mcg|
493794|NCT00718081|O1|Outcome|Sufentanil NanoTab 10 mcg|
493795|NCT00718081|O3|Outcome|Placebo NanoTab|
493796|NCT00718081|O2|Outcome|Sufentanil NanoTab 15 mcg|
493797|NCT00718081|O1|Outcome|Sufentanil NanoTab 10 mcg|
493798|NCT00718081|E3|Reported Event|Placebo NanoTab|
493799|NCT00718081|E2|Reported Event|Sufentanil NanoTab 15 mcg|
493800|NCT00718081|E1|Reported Event|Sufentanil NanoTab 10 mcg|
493801|NCT00718523|B3|Baseline|Total|Total of all reporting groups
493802|NCT00718523|B2|Baseline|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
494102|NCT00719329|P2|Participant Flow|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
493803|NCT00718523|B1|Baseline|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.
AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
493804|NCT00718523|P2|Participant Flow|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
493805|NCT00718523|P1|Participant Flow|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.
AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
493806|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
493807|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.
AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
493808|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
493809|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.
AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
493810|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
493811|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.
AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
493812|NCT00718523|E2|Reported Event|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
493813|NCT00718523|E1|Reported Event|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.
AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
493814|NCT00718640|B1|Baseline|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493827|NCT00718770|P1|Participant Flow|Bexarotene|"Open label - all patients received the intervention
Bexarotene : Bexarotene was given by mouth once a day every day for 1 year. The dose used was 300 mg/m2."
493828|NCT00718770|O1|Outcome|Bexarotene|"Open label - all patients receive intervention
Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
493815|NCT00718640|P1|Participant Flow|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493816|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493817|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493818|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493840|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
513083|NCT00761007|P4|Participant Flow|Placebo|oral tablet, once daily
493819|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493820|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493821|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493822|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493823|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493824|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493825|NCT00718640|E1|Reported Event|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
493826|NCT00718770|B1|Baseline|Bexarotene|"Open label - all patients receive intervention
Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
494359|NCT00720096|B1|Baseline|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
493829|NCT00718770|E1|Reported Event|Bexarotene|"Open label - all patients receive intervention
Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
493830|NCT00718809|B3|Baseline|Total|Total of all reporting groups
493831|NCT00718809|B2|Baseline|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493832|NCT00718809|B1|Baseline|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493833|NCT00718809|P2|Participant Flow|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493834|NCT00718809|P1|Participant Flow|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493835|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493836|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493837|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493838|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493839|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493841|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493842|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493843|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493844|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493845|NCT00718809|E2|Reported Event|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493846|NCT00718809|E1|Reported Event|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
493847|NCT00718861|B3|Baseline|Total|Total of all reporting groups
493848|NCT00718861|B2|Baseline|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493849|NCT00718861|B1|Baseline|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493850|NCT00718861|P2|Participant Flow|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493851|NCT00718861|P1|Participant Flow|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493852|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493853|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493854|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493855|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493856|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493857|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
494170|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
493858|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493859|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493860|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493861|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493862|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493863|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493864|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493865|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493866|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493867|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
494103|NCT00719329|P1|Participant Flow|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
493868|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493869|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493870|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493871|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493872|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493873|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493874|NCT00718861|E2|Reported Event|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
493875|NCT00718861|E1|Reported Event|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
493876|NCT00718887|B3|Baseline|Total|Total of all reporting groups
493877|NCT00718887|B2|Baseline|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493878|NCT00718887|B1|Baseline|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
493879|NCT00718887|P2|Participant Flow|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493880|NCT00718887|P1|Participant Flow|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
493881|NCT00718887|O2|Outcome|Adefovir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493882|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
493883|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493884|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
493885|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493886|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
493887|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493888|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
493889|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493890|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
493891|NCT00718887|O2|Outcome|Adeforvi, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493892|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
493893|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493894|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
493895|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493896|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
493897|NCT00718887|O2|Outcome|Adefovir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493898|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD) for a maximum of 52 weeks.
493899|NCT00718887|E2|Reported Event|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
493900|NCT00718887|E1|Reported Event|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
493901|NCT00719043|B8|Baseline|Total|Total of all reporting groups
493902|NCT00719043|B7|Baseline|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493903|NCT00719043|B6|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493904|NCT00719043|B5|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493905|NCT00719043|B4|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493906|NCT00719043|B3|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493907|NCT00719043|B2|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494322|NCT00719914|O1|Outcome|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
493908|NCT00719043|B1|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493909|NCT00719043|P7|Participant Flow|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493910|NCT00719043|P6|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493911|NCT00719043|P5|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494472|NCT00720382|B1|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
493912|NCT00719043|P4|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493913|NCT00719043|P3|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493914|NCT00719043|P2|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493915|NCT00719043|P1|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493916|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493917|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493918|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494055|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
493919|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493920|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493921|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493922|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494064|NCT00719186|E1|Reported Event|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
494296|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
493923|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493924|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493925|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493926|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493927|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493928|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493929|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493930|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494056|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
494057|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
493931|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493932|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493933|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493934|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493935|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493936|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493937|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493938|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493939|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493940|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493941|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493942|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493943|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493944|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493945|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493946|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493947|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493948|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493949|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493950|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493951|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493952|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493953|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493954|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493955|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493956|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493957|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493958|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493959|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493960|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493961|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493962|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493963|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493964|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493965|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493966|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493967|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493968|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493969|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493970|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493971|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493972|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493973|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493974|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493975|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493976|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493977|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493978|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493979|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493980|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493981|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493982|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493983|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493984|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493985|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493986|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493987|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
493988|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493989|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493990|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493991|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493992|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493993|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493994|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
494058|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
494059|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
493995|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493996|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493997|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494104|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing of the cord
494297|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
493998|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
493999|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
494000|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494001|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494002|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494003|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494004|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
494005|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494006|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494323|NCT00719914|E2|Reported Event|Bolus of Normal Saline|Intra-coronary injection of normal saline.
494007|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
494008|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494009|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494065|NCT00719212|B1|Baseline|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
494010|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494011|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494012|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494013|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494014|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494015|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494016|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494017|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494018|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
494060|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
494061|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
494019|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
494020|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494066|NCT00719212|P1|Participant Flow|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
494105|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing of the cord
494021|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494022|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494023|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494024|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
494025|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494026|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494027|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494028|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494029|NCT00719043|E7|Reported Event|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
494090|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
494030|NCT00719043|E6|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494067|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
494068|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
515781|NCT00765076|B4|Baseline|Total|Total of all reporting groups
494031|NCT00719043|E5|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494032|NCT00719043|E4|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494033|NCT00719043|E3|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494034|NCT00719043|E2|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494035|NCT00719043|E1|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
494036|NCT00719134|B1|Baseline|All Participants|76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
494037|NCT00719134|P1|Participant Flow|All Participants|76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
494038|NCT00719134|O1|Outcome|All Participants|
494039|NCT00719134|O1|Outcome|All Participants|
494040|NCT00719134|E2|Reported Event|Placebo|
494041|NCT00719134|E1|Reported Event|Maxalt|
494042|NCT00719160|B1|Baseline|Entire Study Population|Includes groups randomized to receive 20 mg twice daily of either placebo or esomeprazole first
494043|NCT00719160|P2|Participant Flow|Intervention Placebo First/Esomeprazole Second|In this group this group received the placebo first and then the intervention
494044|NCT00719160|P1|Participant Flow|Intervention Esomeprazole First/Placebo Second|In this group this group received the intervention first and then the placebo
494045|NCT00719160|O2|Outcome|Placebo|Placebo 20 mg twice a day given as either the first or second intervention.
494046|NCT00719160|O1|Outcome|Esomeprazole Study Drug|Esomeprazole 20 mg twice daily given as either the first or second intervention
494047|NCT00719160|O2|Outcome|Placebo|Placebo administered twice daily in either first or second intervention
494048|NCT00719160|O1|Outcome|Esomeprazole|Esomeprazoled administered twice daily in either first or second intervention period
494049|NCT00719160|E1|Reported Event|Entire Study Population|Includes groups randomized to receive 20 mg twice daily of either placebo or esomeprazole first
494050|NCT00719186|B3|Baseline|Total|Total of all reporting groups
494051|NCT00719186|B2|Baseline|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
494052|NCT00719186|B1|Baseline|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
494053|NCT00719186|P2|Participant Flow|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
494054|NCT00719186|P1|Participant Flow|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
494324|NCT00719914|E1|Reported Event|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
494062|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
494063|NCT00719186|E2|Reported Event|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
494101|NCT00719329|P3|Participant Flow|Dry Cord Care|Dry cord care, as recommended by WHO
494069|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
494070|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
494071|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
494072|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
494073|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
494074|NCT00719212|E1|Reported Event|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
494075|NCT00719264|B3|Baseline|Total|Total of all reporting groups
494076|NCT00719264|B2|Baseline|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
494077|NCT00719264|B1|Baseline|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
494078|NCT00719264|P2|Participant Flow|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
494079|NCT00719264|P1|Participant Flow|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
494080|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
494081|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
494082|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
494083|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
494084|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
494085|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
494086|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
494087|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
494088|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
494089|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
498784|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
494091|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
494092|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
494093|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
494094|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
494095|NCT00719264|E2|Reported Event|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
494096|NCT00719264|E1|Reported Event|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
494097|NCT00719329|B4|Baseline|Total|Total of all reporting groups
494098|NCT00719329|B3|Baseline|Dry Cord Care|Dry cord care, as recommended by WHO
494099|NCT00719329|B2|Baseline|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
494100|NCT00719329|B1|Baseline|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
494106|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing of the cord
494107|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing of the cord
494108|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing of the cord
494109|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing of the cord
494110|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing to the cord
494111|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing to the cord
494112|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing to the cord
494113|NCT00719329|E3|Reported Event|Dry Cord Care|Dry cord care, as recommended by WHO
494114|NCT00719329|E2|Reported Event|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
494115|NCT00719329|E1|Reported Event|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
494116|NCT00719355|B3|Baseline|Total|Total of all reporting groups
494117|NCT00719355|B2|Baseline|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
494118|NCT00719355|B1|Baseline|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
494119|NCT00719355|P2|Participant Flow|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
494120|NCT00719355|P1|Participant Flow|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
494121|NCT00719355|O2|Outcome|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
494122|NCT00719355|O1|Outcome|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
494123|NCT00719355|O2|Outcome|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
494124|NCT00719355|O1|Outcome|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
494125|NCT00719355|E2|Reported Event|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
494126|NCT00719355|E1|Reported Event|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
494127|NCT00719472|B1|Baseline|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
494128|NCT00719472|P1|Participant Flow|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
494129|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
494130|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
494131|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
494132|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
494133|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
494134|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
494135|NCT00719472|E1|Reported Event|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
494136|NCT00719537|B3|Baseline|Total|Total of all reporting groups
494137|NCT00719537|B2|Baseline|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
494138|NCT00719537|B1|Baseline|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
494139|NCT00719537|P2|Participant Flow|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
494140|NCT00719537|P1|Participant Flow|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
494141|NCT00719537|O2|Outcome|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
494142|NCT00719537|O1|Outcome|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
494143|NCT00719537|E2|Reported Event|Aspirin and Progesterone|Aspirin and progesterone: aspirin 81 mg once a day oral progesterone 200mg twice daily
494144|NCT00719537|E1|Reported Event|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo
494145|NCT00719563|B3|Baseline|Total|Total of all reporting groups
494146|NCT00719563|B2|Baseline|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494147|NCT00719563|B1|Baseline|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494148|NCT00719563|P2|Participant Flow|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494149|NCT00719563|P1|Participant Flow|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494150|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494151|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494152|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494153|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494154|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494155|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494156|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494157|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494158|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494159|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494160|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494161|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494162|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494163|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494164|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494165|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494166|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494167|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494168|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494171|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494172|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment..
494173|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494174|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494175|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494176|NCT00719563|E2|Reported Event|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494177|NCT00719563|E1|Reported Event|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
494178|NCT00719615|B4|Baseline|Total|Total of all reporting groups
494179|NCT00719615|B3|Baseline|Active Thyroid Cancer|
494180|NCT00719615|B2|Baseline|Thyroid Cancer in Remission|
494181|NCT00719615|B1|Baseline|Thyroid Nodules|
494182|NCT00719615|P3|Participant Flow|Active Thyroid Cancer|
494183|NCT00719615|P2|Participant Flow|Thyroid Cancer in Remission|
494184|NCT00719615|P1|Participant Flow|Thyroid Nodules|
494185|NCT00719615|O3|Outcome|Active Thyroid Cancer|
494186|NCT00719615|O2|Outcome|Thyroid Cancer in Remission|
494187|NCT00719615|O1|Outcome|Thyroid Nodules|
494188|NCT00719615|E3|Reported Event|Active Thyroid Cancer|
494189|NCT00719615|E2|Reported Event|Thyroid Cancer in Remission|
494190|NCT00719615|E1|Reported Event|Thyroid Nodules|
494191|NCT00719680|B1|Baseline|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
494192|NCT00719680|P1|Participant Flow|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
494193|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494194|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494195|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494196|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494197|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494198|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494199|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494200|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494201|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494202|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494203|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494204|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494205|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494206|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494207|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494208|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494209|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
494210|NCT00719680|E1|Reported Event|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
494211|NCT00719706|B3|Baseline|Total|Total of all reporting groups
494212|NCT00719706|B2|Baseline|Placebo|Participants taking placebo.
494213|NCT00719706|B1|Baseline|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
494214|NCT00719706|P2|Participant Flow|Placebo|Participants taking placebo.
494215|NCT00719706|P1|Participant Flow|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
494216|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
494217|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
494218|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
494219|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
494220|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
494221|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
494222|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
494223|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
494224|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
494225|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
494226|NCT00719706|E2|Reported Event|Placebo|Participants taking placebo.
494227|NCT00719706|E1|Reported Event|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
494228|NCT00719732|B1|Baseline|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
494294|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
494229|NCT00719732|P1|Participant Flow|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
494230|NCT00719732|O1|Outcome|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
494231|NCT00719732|E1|Reported Event|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
494232|NCT00719810|B4|Baseline|Total|Total of all reporting groups
494233|NCT00719810|B3|Baseline|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
494234|NCT00719810|B2|Baseline|Delafloxacin 450 mg IV q12h|
494235|NCT00719810|B1|Baseline|Delafloxacin 300 mg IV q12h|
494236|NCT00719810|P3|Participant Flow|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
494237|NCT00719810|P2|Participant Flow|Delafloxacin 450 mg IV q12h|
494238|NCT00719810|P1|Participant Flow|Delafloxacin 300 mg IV q12h|
494239|NCT00719810|O3|Outcome|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
494240|NCT00719810|O2|Outcome|Delafloxacin 450 mg IV q12h|
494241|NCT00719810|O1|Outcome|Delafloxacin 300 mg IV q12h|
494242|NCT00719810|O3|Outcome|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
494243|NCT00719810|O2|Outcome|Delafloxacin 450 mg IV q12h|
494244|NCT00719810|O1|Outcome|Delafloxacin 300 mg IV q12h|
494245|NCT00719810|E3|Reported Event|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
494246|NCT00719810|E2|Reported Event|Delafloxacin 450 mg IV q12h|
494247|NCT00719810|E1|Reported Event|Delafloxacin 300 mg IV q12h|
494248|NCT00719849|B3|Baseline|Total|Total of all reporting groups
494249|NCT00719849|B2|Baseline|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
494250|NCT00719849|B1|Baseline|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
494251|NCT00719849|P2|Participant Flow|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
494252|NCT00719849|P1|Participant Flow|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
494253|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494254|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494255|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494256|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494257|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494258|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494295|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
494259|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494260|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494261|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494262|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494263|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494264|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494265|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494266|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494267|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494268|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494360|NCT00720096|P2|Participant Flow|Topotecan|Topotecan - Chemotherapy single agent systemic.
494911|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
494269|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494270|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494271|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494272|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494273|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
518692|NCT00778102|B3|Baseline|Total|Total of all reporting groups
494274|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494275|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494276|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494277|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494278|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494279|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494280|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494281|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494282|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494283|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494356|NCT00720083|E1|Reported Event|RT+ Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
494284|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494285|NCT00719849|E2|Reported Event|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day –1
Equine ATG 30mg/Kg Days –6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494286|NCT00719849|E1|Reported Event|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Cyclophosphamide 50 mg/Kg Day –6
Fludarabine 40mg/m2 Days –6 to –2
TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
494287|NCT00719862|B3|Baseline|Total|Total of all reporting groups
494288|NCT00719862|B2|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
494289|NCT00719862|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
494290|NCT00719862|P2|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
494291|NCT00719862|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
494292|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
494293|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
494298|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
494299|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
494300|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
494301|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
494302|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
494303|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
494304|NCT00719862|E2|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
494305|NCT00719862|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
494306|NCT00719901|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
494307|NCT00719901|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
494308|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
494309|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
494310|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
494311|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
494312|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
494313|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
494314|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
494315|NCT00719901|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
494316|NCT00719914|B3|Baseline|Total|Total of all reporting groups
494317|NCT00719914|B2|Baseline|Bolus of Normal Saline|Intra-coronary injection of normal saline.
494318|NCT00719914|B1|Baseline|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
494319|NCT00719914|P2|Participant Flow|Bolus of Normal Saline|Intracoronary injection of normal saline.
494320|NCT00719914|P1|Participant Flow|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
494321|NCT00719914|O2|Outcome|Bolus of Normal Saline|Intra-coronary injection of normal saline.
494325|NCT00719953|B1|Baseline|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
494326|NCT00719953|P1|Participant Flow|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
494327|NCT00719953|O1|Outcome|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
494328|NCT00719953|E1|Reported Event|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
494329|NCT00720057|B3|Baseline|Total|Total of all reporting groups
494330|NCT00720057|B2|Baseline|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494331|NCT00720057|B1|Baseline|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494332|NCT00720057|P2|Participant Flow|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494333|NCT00720057|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494334|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494335|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494336|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494337|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494338|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494339|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494340|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494341|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494342|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494343|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494344|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494345|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494346|NCT00720057|E2|Reported Event|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494347|NCT00720057|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
494348|NCT00720083|B3|Baseline|Total|Total of all reporting groups
494349|NCT00720083|B2|Baseline|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
494350|NCT00720083|B1|Baseline|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
494351|NCT00720083|P2|Participant Flow|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
494352|NCT00720083|P1|Participant Flow|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
494353|NCT00720083|O2|Outcome|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
494354|NCT00720083|O1|Outcome|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
494355|NCT00720083|E2|Reported Event|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
494361|NCT00720096|P1|Participant Flow|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
494362|NCT00720096|O2|Outcome|Topotecan|Topotecan - Chemotherapy single agent systemic.
494363|NCT00720096|O1|Outcome|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
494364|NCT00720096|O2|Outcome|Topotecan|Topotecan - Chemotherapy single agent systemic.
494365|NCT00720096|O1|Outcome|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
494366|NCT00720096|E2|Reported Event|Topotecan|Topotecan - Chemotherapy single agent systemic.
494367|NCT00720096|E1|Reported Event|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
494368|NCT00720109|B1|Baseline|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description
Asparaginase: Given IT
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dasatinib: Given PO
Daunorubicin Hydrochloride: Given IV
Dexamethasone: Given IV or PO
Etoposide: Given IV
Filgrastim: Given IV or SC
Hydrocortisone Sodium Succinate: Given IT
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV or PO
Mercaptopurine: Given PO
Methotrexate: Given IT, PO, or IV
Methylprednisolone: Given IV
Pegaspargase: Given IM
Prednisone: Given PO or IV
Radiation Therapy: Some patients undergo cranial RT
Vincristine Sulfate: Given IV"
494369|NCT00720109|P3|Participant Flow|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
494370|NCT00720109|P2|Participant Flow|Standard-risk|Based on Minimal Residual Disease, less than 1%.
494371|NCT00720109|P1|Participant Flow|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description
Asparaginase: Given IT
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dasatinib: Given PO
Daunorubicin Hydrochloride: Given IV
Dexamethasone: Given IV or PO
Etoposide: Given IV
Filgrastim: Given IV or SC
Hydrocortisone Sodium Succinate: Given IT
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV or PO
Mercaptopurine: Given PO
Methotrexate: Given IT, PO, or IV
Methylprednisolone: Given IV
Pegaspargase: Given IM
Prednisone: Given PO or IV
Radiation Therapy: Some patients undergo cranial RT
Vincristine Sulfate: Given IV"
494372|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
494373|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
494407|NCT00720278|P3|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494408|NCT00720278|P2|Participant Flow|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494374|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description
Asparaginase: Given IT
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dasatinib: Given PO
Daunorubicin Hydrochloride: Given IV
Dexamethasone: Given IV or PO
Etoposide: Given IV
Filgrastim: Given IV or SC
Hydrocortisone Sodium Succinate: Given IT
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV or PO
Mercaptopurine: Given PO
Methotrexate: Given IT, PO, or IV
Methylprednisolone: Given IV
Pegaspargase: Given IM
Prednisone: Given PO or IV
Radiation Therapy: Some patients undergo cranial RT
Vincristine Sulfate: Given IV"
494375|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
494376|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
494377|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description
Asparaginase: Given IT
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dasatinib: Given PO
Daunorubicin Hydrochloride: Given IV
Dexamethasone: Given IV or PO
Etoposide: Given IV
Filgrastim: Given IV or SC
Hydrocortisone Sodium Succinate: Given IT
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV or PO
Mercaptopurine: Given PO
Methotrexate: Given IT, PO, or IV
Methylprednisolone: Given IV
Pegaspargase: Given IM
Prednisone: Given PO or IV
Radiation Therapy: Some patients undergo cranial RT
Vincristine Sulfate: Given IV"
494378|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
494379|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
494380|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description
Asparaginase: Given IT
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dasatinib: Given PO
Daunorubicin Hydrochloride: Given IV
Dexamethasone: Given IV or PO
Etoposide: Given IV
Filgrastim: Given IV or SC
Hydrocortisone Sodium Succinate: Given IT
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV or PO
Mercaptopurine: Given PO
Methotrexate: Given IT, PO, or IV
Methylprednisolone: Given IV
Pegaspargase: Given IM
Prednisone: Given PO or IV
Radiation Therapy: Some patients undergo cranial RT
Vincristine Sulfate: Given IV"
494381|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|Feasibility measured by DLT rates in safety phase, Toxicities define DLTs and are summarized and reviewed to assess feasibility of administering the combination therapy with dasatinib
494382|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
494383|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
494384|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description
Asparaginase: Given IT
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dasatinib: Given PO
Daunorubicin Hydrochloride: Given IV
Dexamethasone: Given IV or PO
Etoposide: Given IV
Filgrastim: Given IV or SC
Hydrocortisone Sodium Succinate: Given IT
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV or PO
Mercaptopurine: Given PO
Methotrexate: Given IT, PO, or IV
Methylprednisolone: Given IV
Pegaspargase: Given IM
Prednisone: Given PO or IV
Radiation Therapy: Some patients undergo cranial RT
Vincristine Sulfate: Given IV"
494385|NCT00720109|E3|Reported Event|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
494386|NCT00720109|E2|Reported Event|Standard-risk|Based on Minimal Residual Disease, less than 1%.
494387|NCT00720109|E1|Reported Event|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description
Asparaginase: Given IT
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dasatinib: Given PO
Daunorubicin Hydrochloride: Given IV
Dexamethasone: Given IV or PO
Etoposide: Given IV
Filgrastim: Given IV or SC
Hydrocortisone Sodium Succinate: Given IT
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV or PO
Mercaptopurine: Given PO
Methotrexate: Given IT, PO, or IV
Methylprednisolone: Given IV
Pegaspargase: Given IM
Prednisone: Given PO or IV
Radiation Therapy: Some patients undergo cranial RT
Vincristine Sulfate: Given IV"
494458|NCT00720343|E1|Reported Event|Choline|"Oral choline
Choline: Oral Choline 20 grams before surgery"
494459|NCT00720369|B3|Baseline|Total|Total of all reporting groups
494388|NCT00720122|B1|Baseline|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
494389|NCT00720122|P1|Participant Flow|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
494390|NCT00720122|O1|Outcome|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
494391|NCT00720122|E1|Reported Event|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
494392|NCT00720226|B3|Baseline|Total|Total of all reporting groups
494393|NCT00720226|B2|Baseline|Placebo|Placebo 1 tablet daily
494394|NCT00720226|B1|Baseline|Losartan|Losartan 100 mg daily
494395|NCT00720226|P2|Participant Flow|Placebo|"Placebo 1 pill daily
Placebo: Placebo pill daily"
494396|NCT00720226|P1|Participant Flow|Losartan|"Losartan 100 mg daily
Losartan: Losartan 100 mg daily"
494397|NCT00720226|O2|Outcome|Placebo|Placebo: Placebo pill daily (Participants with 5-35% emphysema)
494398|NCT00720226|O1|Outcome|Losartan|Losartan: Losartan 100 mg daily (participants with 5-35% emphysema)
494399|NCT00720226|O2|Outcome|Placebo|Placebo: Placebo pill daily (Participants with 5-35% emphysema)
494400|NCT00720226|O1|Outcome|Losartan|Losartan: Losartan 100 mg daily (participants with 5-35% emphysema)
494401|NCT00720226|E2|Reported Event|Placebo|"Placebo 1 pill daily
Placebo: Placebo pill daily"
494402|NCT00720226|E1|Reported Event|Losartan 100 mg Daily|"Losartan 100 mg daily
Losartan: Losartan 100 mg daily"
494403|NCT00720278|B4|Baseline|Total|Total of all reporting groups
494404|NCT00720278|B3|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494405|NCT00720278|B2|Baseline|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494406|NCT00720278|B1|Baseline|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494409|NCT00720278|P1|Participant Flow|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494410|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494411|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494412|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494413|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494414|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494415|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494416|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494417|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494418|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494419|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494420|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494421|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494422|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494423|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494424|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494425|NCT00720278|E3|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494426|NCT00720278|E2|Reported Event|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494427|NCT00720278|E1|Reported Event|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
494428|NCT00720330|B4|Baseline|Total|Total of all reporting groups
494429|NCT00720330|B3|Baseline|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo"
494430|NCT00720330|B2|Baseline|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.
Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
494431|NCT00720330|B1|Baseline|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation
ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
494432|NCT00720330|P3|Participant Flow|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo"
494433|NCT00720330|P2|Participant Flow|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.
Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
494434|NCT00720330|P1|Participant Flow|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation
ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
494435|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo"
494436|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.
Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
494437|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation
ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
494438|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo"
494439|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.
Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
494440|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation
ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
494441|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo"
494470|NCT00720382|B3|Baseline|Total|Total of all reporting groups
494471|NCT00720382|B2|Baseline|Nasonex®|Mometasone furoate 200 mcg
494442|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.
Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
494443|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation
ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
494444|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo"
494445|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.
Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
494446|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation
ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
494447|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo"
494448|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.
Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
494449|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation
ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
494450|NCT00720330|E3|Reported Event|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo"
494451|NCT00720330|E2|Reported Event|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.
Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
494452|NCT00720330|E1|Reported Event|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation
ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
494453|NCT00720343|B1|Baseline|Choline or Placebo|"Oral choline or Placebo
Choline: Oral Choline or Placebo 20 grams before surgery"
494454|NCT00720343|P1|Participant Flow|Choline or Placebo|"Oral choline or Placebo
Choline: Oral Choline or Placebo 20 grams before surgery"
494455|NCT00720343|O2|Outcome|Placebo|"Gelatin Capsule
Placebo: Gelatin Capsule"
494456|NCT00720343|O1|Outcome|Choline|"Oral choline
Choline: Oral Choline 20 grams before surgery"
494457|NCT00720343|E2|Reported Event|Placebo|"Gelatin Capsule
Placebo: Gelatin Capsule"
494460|NCT00720369|B2|Baseline|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
494461|NCT00720369|B1|Baseline|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
494462|NCT00720369|P2|Participant Flow|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
494463|NCT00720369|P1|Participant Flow|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
494464|NCT00720369|O2|Outcome|Healthy Controls|Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.
494465|NCT00720369|O1|Outcome|CoQ10|Open Label Study
494466|NCT00720369|O2|Outcome|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group.
494467|NCT00720369|O1|Outcome|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated.
494468|NCT00720369|E2|Reported Event|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
494469|NCT00720369|E1|Reported Event|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
494473|NCT00720382|P2|Participant Flow|Nasonex®|Mometasone furoate 200 mcg
494474|NCT00720382|P1|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
494475|NCT00720382|O2|Outcome|Nasonex®|Mometasone furoate 200 mcg
494476|NCT00720382|O1|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
494477|NCT00720382|O2|Outcome|Nasonex®|Mometasone furoate 200 mcg
494478|NCT00720382|O1|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
494479|NCT00720382|E2|Reported Event|Nasonex®|Mometasone furoate 200 mcg
494480|NCT00720382|E1|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
494481|NCT00720434|B5|Baseline|Total|Total of all reporting groups
494482|NCT00720434|B4|Baseline|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494483|NCT00720434|B3|Baseline|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494484|NCT00720434|B2|Baseline|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494485|NCT00720434|B1|Baseline|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
494486|NCT00720434|P4|Participant Flow|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494515|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
494516|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494517|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
494518|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494487|NCT00720434|P3|Participant Flow|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494488|NCT00720434|P2|Participant Flow|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494489|NCT00720434|P1|Participant Flow|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
494490|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494491|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494492|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494493|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
494494|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494495|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494496|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494497|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
494498|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494610|NCT00720759|B5|Baseline|Total|Total of all reporting groups
494499|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494500|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494501|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
494502|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494503|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494504|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494505|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
494506|NCT00720434|E4|Reported Event|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494507|NCT00720434|E3|Reported Event|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494508|NCT00720434|E2|Reported Event|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
494509|NCT00720434|E1|Reported Event|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
494510|NCT00720473|B3|Baseline|Total|Total of all reporting groups
494511|NCT00720473|B2|Baseline|Control Subjects|Age matched controls without BPD
494512|NCT00720473|B1|Baseline|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494513|NCT00720473|P2|Participant Flow|B: Healthy Control|No Intervention
494514|NCT00720473|P1|Participant Flow|A: BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
498785|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
494519|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494520|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494521|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494522|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
494523|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494524|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
494525|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494526|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
494527|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494528|NCT00720473|O1|Outcome|A: Other|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494529|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
494530|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494531|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
494532|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494533|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
494534|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study
Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
494535|NCT00720473|E2|Reported Event|BPD Subjects|
494536|NCT00720473|E1|Reported Event|Control Subjects|Age matched controls without BPD
494537|NCT00720499|B1|Baseline|Overall Study|"A randomised, double-blind, 2-way cross-over study. The two treatment periods were separated by a wash-out period of 14 days during which they received open-label Tiotropium 5 mcg. The 2 treatments, administered once daily in the morning via the respimat inhaler, were :
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg
Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
494538|NCT00720499|P2|Participant Flow|Tio+Olo5/5µg / Tio+Olo5/2µg|"Patients received fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 5 µg followed by fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 2 µg.
Both treatments were administered once daily in the morning via the respimat inhaler."
494539|NCT00720499|P1|Participant Flow|Tio+Olo 5/2µg / Tio+Olo5/5µg|"Patients received fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 2 µg followed by fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 5 µg.
Both treatments were administered once daily in the morning via the respimat inhaler."
494540|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494541|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494542|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494543|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494544|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494545|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494546|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494547|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494548|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494549|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494550|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494551|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494552|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494553|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494554|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494555|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494556|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494557|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494558|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494559|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494560|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494561|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494562|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494563|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494707|NCT00715104|O2|Outcome|No Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
494564|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494565|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494566|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494567|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494568|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494569|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494570|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494571|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494572|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494573|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494574|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494575|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494576|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494577|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494578|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494611|NCT00720759|B4|Baseline|Arm 4|"Placebo + condensed treatment
Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
494579|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494580|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494581|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494582|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494583|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494584|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494585|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494586|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494587|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494588|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494589|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494590|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494591|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494592|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494593|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494594|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494595|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494596|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494597|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494598|NCT00720499|E2|Reported Event|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494599|NCT00720499|E1|Reported Event|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
494600|NCT00720629|B1|Baseline|First Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
494601|NCT00720629|P1|Participant Flow|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
494602|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
494603|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
494604|NCT00720629|O2|Outcome|5 Year Analysis Group|First Study Stage: Study Treatment. Visilizumab, Tacrolimus and Methotrexate.
494605|NCT00720629|O1|Outcome|2 Year Analysis Group|First Study Stage: Study Treatment. Visilizumab, Tacrolimus and Methotrexate.
494606|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
494607|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
494608|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
494609|NCT00720629|E1|Reported Event|First Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
494612|NCT00720759|B3|Baseline|Arm 3|"Placebo + distributed treatment
Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
494613|NCT00720759|B2|Baseline|Arm 2|"D-cycloserine + condensed treatment
D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
494614|NCT00720759|B1|Baseline|Arm 1|"D-cycloserine + distributed treatment
D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
494615|NCT00720759|P4|Participant Flow|Arm 4|"Placebo + condensed treatment
Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
494616|NCT00720759|P3|Participant Flow|Arm 3|"Placebo + distributed treatment
Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
494617|NCT00720759|P2|Participant Flow|Arm 2|"D-cycloserine + condensed treatment
D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
494618|NCT00720759|P1|Participant Flow|Arm 1|"D-cycloserine + distributed treatment
D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
494619|NCT00720759|O4|Outcome|Arm 4|"Placebo + condensed treatment
Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
494620|NCT00720759|O3|Outcome|Arm 3|"Placebo + distributed treatment
Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
494621|NCT00720759|O2|Outcome|Arm 2|"D-cycloserine + condensed treatment
D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
494708|NCT00715104|O1|Outcome|Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
494622|NCT00720759|O1|Outcome|Arm 1|"D-cycloserine + distributed treatment
D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
494623|NCT00720759|E4|Reported Event|Arm 4|"Placebo + condensed treatment
Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
494624|NCT00720759|E3|Reported Event|Arm 3|"Placebo + distributed treatment
Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
494625|NCT00720759|E2|Reported Event|Arm 2|"D-cycloserine + condensed treatment
D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
494626|NCT00720759|E1|Reported Event|Arm 1|"D-cycloserine + distributed treatment
D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
494627|NCT00720798|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494628|NCT00720798|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494629|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494630|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494631|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494632|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494633|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494634|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494635|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494690|NCT00715104|P3|Participant Flow|Sipuleucel-T Without Randomization to Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment).
494636|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494637|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494638|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494639|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494640|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494641|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494642|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494709|NCT00715104|O4|Outcome|72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster
494643|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494644|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494645|NCT00720798|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
494646|NCT00714792|B3|Baseline|Total|Total of all reporting groups
494647|NCT00714792|B2|Baseline|Control Subjects|Control subjects
494648|NCT00714792|B1|Baseline|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
494649|NCT00714792|P2|Participant Flow|Control Subjects|Control subjects
494650|NCT00714792|P1|Participant Flow|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
494651|NCT00714792|O2|Outcome|Control Subjects|
494652|NCT00714792|O1|Outcome|Overactive Bladder Subjects|
494653|NCT00714792|E2|Reported Event|Control Subjects|Control subjects
494654|NCT00714792|E1|Reported Event|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
494655|NCT00714870|B3|Baseline|Total|Total of all reporting groups
494656|NCT00714870|B2|Baseline|Control Group|control group: this group will not attend the nutrition and exercise program
494657|NCT00714870|B1|Baseline|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program
Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
494658|NCT00714870|P2|Participant Flow|Control Group: Standard of Care at Pediatrician's Office|control group: this group will not attend the nutrition and exercise program
494659|NCT00714870|P1|Participant Flow|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program
Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
494660|NCT00714870|O2|Outcome|Control|Control group received the standard of care at pediatrician's office
494661|NCT00714870|O1|Outcome|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program
Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
494662|NCT00714870|E2|Reported Event|Control|
494691|NCT00715104|P2|Participant Flow|Sipuleucel-T Without Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
494692|NCT00715104|P1|Participant Flow|Sipuleucel-T With Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
494693|NCT00715104|O8|Outcome|No Booster: 72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to no booster
494663|NCT00714870|E1|Reported Event|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program
Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
494664|NCT00714948|B1|Baseline|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.
Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
494665|NCT00714948|P1|Participant Flow|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.
Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
494666|NCT00714948|O1|Outcome|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.
Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
494710|NCT00715104|O3|Outcome|48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
494711|NCT00715104|O2|Outcome|24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
494667|NCT00714948|E1|Reported Event|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.
Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
494668|NCT00715026|B1|Baseline|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
494669|NCT00715026|P1|Participant Flow|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
494670|NCT00715026|O1|Outcome|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
494671|NCT00715026|O1|Outcome|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
494672|NCT00715026|E1|Reported Event|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
494673|NCT00715078|B4|Baseline|Total|Total of all reporting groups
494674|NCT00715078|B3|Baseline|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
494675|NCT00715078|B2|Baseline|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
494676|NCT00715078|B1|Baseline|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
494677|NCT00715078|P3|Participant Flow|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
494678|NCT00715078|P2|Participant Flow|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
494679|NCT00715078|P1|Participant Flow|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
494680|NCT00715078|O3|Outcome|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
494681|NCT00715078|O2|Outcome|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
494682|NCT00715078|O1|Outcome|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
494683|NCT00715078|E3|Reported Event|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
494684|NCT00715078|E2|Reported Event|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
494685|NCT00715078|E1|Reported Event|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 peripheral blood mononuclear cells (PBMCs) per mL
494686|NCT00715104|B4|Baseline|Total|Total of all reporting groups
494687|NCT00715104|B3|Baseline|Sipuleucel-T Without Randomization to Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase(received no further sipuleucel-T treatment).
494688|NCT00715104|B2|Baseline|Sipuleucel-T Without Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
494689|NCT00715104|B1|Baseline|Sipuleucel-T With Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
494912|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
494694|NCT00715104|O7|Outcome|Booster: 72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster
494695|NCT00715104|O6|Outcome|No Booster: 48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to no booster
494696|NCT00715104|O5|Outcome|Booster: 48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
494697|NCT00715104|O4|Outcome|No Booster: 24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to no booster
494698|NCT00715104|O3|Outcome|Booster: 24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
494699|NCT00715104|O2|Outcome|No Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
494700|NCT00715104|O1|Outcome|Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
494701|NCT00715104|O8|Outcome|No Booster: 72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
494702|NCT00715104|O7|Outcome|Booster: 72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
494703|NCT00715104|O6|Outcome|No Booster: 48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
494704|NCT00715104|O5|Outcome|Booster: 48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
494705|NCT00715104|O4|Outcome|No Booster: 24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to no booster
494706|NCT00715104|O3|Outcome|Booster: 24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
494765|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
494712|NCT00715104|O1|Outcome|12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
494713|NCT00715104|O4|Outcome|72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
494714|NCT00715104|O3|Outcome|48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
494715|NCT00715104|O2|Outcome|24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
494716|NCT00715104|O1|Outcome|12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
494717|NCT00715104|O4|Outcome|12 Weeks Post-RP|ELISPOT for PAP at 12 Weeks post-RP
494718|NCT00715104|O3|Outcome|6 Weeks Post-RP|ELISPOT for PAP at 6 Weeks post-RP
494719|NCT00715104|O2|Outcome|Pre-RP Visit|ELISPOT for PAP at pre-RP visit
494720|NCT00715104|O1|Outcome|Baseline|ELISPOT for PAP at baseline
494721|NCT00715104|O4|Outcome|12 Weeks Post-RP|ELISPOT for PA2024 at 12 Weeks post-RP
494722|NCT00715104|O3|Outcome|6 Weeks Post-RP|ELISPOT for PA2024 at 6 Weeks post-RP
494723|NCT00715104|O2|Outcome|Pre-RP Visit|ELISPOT for PA2024 at Pre-RP Visit
494724|NCT00715104|O1|Outcome|Baseline|ELISPOT for PA2024 at baseline
494725|NCT00715104|O4|Outcome|Post-RP Tumor Interface Tissue|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
494726|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
494727|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
494728|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
494729|NCT00715104|O4|Outcome|Post-RP Tumor Interface Tissue|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
494730|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
494731|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
494732|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
494733|NCT00715104|O4|Outcome|Post-RP Tumor Interface|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
494734|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
494735|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
494736|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
494737|NCT00715104|E3|Reported Event|Sipuleucel-T Without Randomization to Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment).
494738|NCT00715104|E2|Reported Event|Sipuleucel-T Without Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
494739|NCT00715104|E1|Reported Event|Sipuleucel-T With Booster|Subjects receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then received an additional booster infusion 13 weeks after RP.
494740|NCT00715117|B3|Baseline|Total|Total of all reporting groups
494741|NCT00715117|B2|Baseline|B: Naltrexone, Active Drug Group|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 16 weeks
494742|NCT00715117|B1|Baseline|A: Placebo Control Group|Subjects will receive placebo for for the first 8weeks then be crossed over to active drug for the last 8 weeks
494743|NCT00715117|P2|Participant Flow|B: Naltrexone Then Naltrexone|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 weeks followed by the same treatment for an additional 8 weeks
494744|NCT00715117|P1|Participant Flow|A: Placebo Then Naltrexone|Subjects will receive placebo for for the first 8weeks then be crossed over to active drug naltrexone for the last 8 weeks
494745|NCT00715117|O2|Outcome|Naltrexone|These subjects were treated with naltrexone at a dose 0.1 mg/kg not to exceed 4.5 mg po daily for either 8 or 16 weeks.
494746|NCT00715117|O1|Outcome|Placebo|These subjects received placebo for 8 weeks by mouth daily.
494747|NCT00715117|O2|Outcome|Week 16|Quality of life survey values in all subjects determined at week 16 after all 12 participants had received naltrexone for either 8 or 16 weeks.
494748|NCT00715117|O1|Outcome|Baseline|Quality of life values in all subjects at baseline before receiving placebo or naltrexone.
494749|NCT00715117|O3|Outcome|Naltrexone|Includes all Naltrexone treated participants 8 weeks of treatment.
494750|NCT00715117|O2|Outcome|Placebo|Patients were treated with a placebo (sugar pill)for 8 weeks.
494751|NCT00715117|O1|Outcome|All Participants Pretreament|All participants prior to receiving placebo or naltrexone at week 0
494752|NCT00715117|E2|Reported Event|B: Naltrexone, Active Drug Group|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 or 16 weeks
494753|NCT00715117|E1|Reported Event|A: Placebo Control Group|Subjects will receive placebo for 8weeks
494754|NCT00715208|B3|Baseline|Total|Total of all reporting groups
494755|NCT00715208|B2|Baseline|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
494756|NCT00715208|B1|Baseline|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
494757|NCT00715208|P2|Participant Flow|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
494758|NCT00715208|P1|Participant Flow|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
494759|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
494760|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
494761|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
494762|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
494763|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
494764|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
494766|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
494767|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
494768|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
494769|NCT00715208|E2|Reported Event|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
494770|NCT00715208|E1|Reported Event|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
494771|NCT00720941|B3|Baseline|Total|Total of all reporting groups
494772|NCT00720941|B2|Baseline|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494773|NCT00720941|B1|Baseline|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494774|NCT00720941|P2|Participant Flow|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494775|NCT00720941|P1|Participant Flow|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494776|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494777|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494778|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494779|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494780|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494781|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494845|NCT00721110|E2|Reported Event|Placebo|placebo is administered intravenously through out surgery and 24 hours after surgery.
494913|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
494782|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494783|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494784|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494785|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494786|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494787|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494788|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494789|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
495537|NCT00723801|O2|Outcome|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
494790|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494791|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494792|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494793|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494794|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494795|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494796|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494797|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494798|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494799|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494800|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494801|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494802|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494977|NCT00721175|E2|Reported Event|Plastic Stent|plastic stent group
494803|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494804|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494805|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494806|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494807|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494808|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494809|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494810|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494811|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494812|NCT00720941|E2|Reported Event|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494813|NCT00720941|E1|Reported Event|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
494814|NCT00721110|B5|Baseline|Total|Total of all reporting groups
494815|NCT00721110|B4|Baseline|Placebo|"A placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine or Lidocaine not given"
494816|NCT00721110|B3|Baseline|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
494817|NCT00721110|B2|Baseline|Lidocaine|"Intravenous lidocaine Group - A lidocaine is administered intravenously through out surgery and 24 hours after surgery.
Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours."
494818|NCT00721110|B1|Baseline|Lidocaine/Ketamine|"Intravenous Lidocaine and Ketamine Group -
Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours. Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters."
494819|NCT00721110|P4|Participant Flow|Placebo|"A placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine or lidocaine not given"
494820|NCT00721110|P3|Participant Flow|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
494821|NCT00721110|P2|Participant Flow|Lidocaine|Intravenous lidocaine Group - Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours.
494822|NCT00721110|P1|Participant Flow|Lidocaine/Ketamine|"Intravenous Lidocaine + Ketamine Group
Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours.
Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours.
Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters"
494823|NCT00721110|O4|Outcome|Nonketamine|"A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine not given"
494906|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
494824|NCT00721110|O3|Outcome|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
494825|NCT00721110|O2|Outcome|Nonlidocaine|"Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.
Placebo boluses and infusions will be substituted for the lidocaine"
494826|NCT00721110|O1|Outcome|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
494827|NCT00721110|O4|Outcome|Nonketamine|"A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine not given"
494828|NCT00721110|O3|Outcome|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
494829|NCT00721110|O2|Outcome|Nonlidocaine|"Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.
Placebo boluses and infusions will be substituted for the lidocaine"
494830|NCT00721110|O1|Outcome|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
494831|NCT00721110|O4|Outcome|Nonketamine|"A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine not given"
494832|NCT00721110|O3|Outcome|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
494833|NCT00721110|O2|Outcome|Nonlidocaine|"Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.
Placebo boluses and infusions will be substituted for the lidocaine"
494834|NCT00721110|O1|Outcome|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
494835|NCT00721110|O4|Outcome|Nonketamine|"A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine not given"
494836|NCT00721110|O3|Outcome|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
494837|NCT00721110|O2|Outcome|Nonlidocaine|"Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.
Placebo boluses and infusions will be substituted for the lidocaine"
494838|NCT00721110|O1|Outcome|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
494839|NCT00721110|O4|Outcome|Nonketamine|"A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine not given"
494840|NCT00721110|O3|Outcome|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
494841|NCT00721110|O2|Outcome|Nonlidocaine|"Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.
Placebo boluses and infusions will be substituted for the lidocaine"
494842|NCT00721110|O1|Outcome|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
494843|NCT00721110|E4|Reported Event|Ketamine + Lidocaine|both ketamine and Lidocaine administered intravenously throughout surgery and during the 24 hours after surgery.
494844|NCT00721110|E3|Reported Event|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
494846|NCT00721110|E1|Reported Event|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
494847|NCT00721123|B1|Baseline|Tocilizumab 8 mg/kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
494848|NCT00721123|P1|Participant Flow|Tocilizumab 8 mg/kg|Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.
494849|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
494850|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
494851|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
494852|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
494853|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
494854|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
494855|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
494856|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
494857|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
494858|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
494859|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
494860|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
494861|NCT00721123|O1|Outcome|Tocilizumab 8 mg/kg|Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.
494862|NCT00721123|O5|Outcome|Months Greater Than 48|Participants with scores during Months greater than 48, which equates to Weeks 193-264 (Total PY=731.93).
494863|NCT00721123|O4|Outcome|Months 37 − 48|Participants with scores during Months 37 − 48, which equates to Weeks 145-192 (Total PY=388.25).
494864|NCT00721123|O3|Outcome|Months 25 - 36|Participants with scores during Months 25 - 36, which equates to Weeks 97-144 (Total PY=410.93).
495538|NCT00723801|O1|Outcome|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
494865|NCT00721123|O2|Outcome|Months 13 − 24|Participants with scores during Months 13 − 24, which equates to Weeks 49-96 (Total PY=444.49).
494866|NCT00721123|O1|Outcome|Months 0 - 12|Participants with scores during Months 0-12, which equates to baseline through Week 48 (Total PY=486.34).
494867|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
494868|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
494869|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
494870|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
494871|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
494872|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
494873|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
494874|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
494875|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
494876|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
494877|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
494878|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
494879|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
494880|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
494881|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
494882|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
494883|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
494884|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
494885|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
494886|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
494887|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
494888|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
494889|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
494890|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
494891|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
494892|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
494893|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
494894|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
494895|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
494896|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
494897|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
494898|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
494899|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
494900|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
494901|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
494902|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
494903|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
494904|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
494905|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
498786|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
494914|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
494915|NCT00721123|O5|Outcome|Months Greater Than 48|Participants with scores during Months greater than 48, which equates to Weeks 193-264.
494916|NCT00721123|O4|Outcome|Months 37 − 48|Participants with scores during Months 37 − 48, which equates to Weeks 145-192.
494917|NCT00721123|O3|Outcome|Months 25 - 36|Participants with scores during Months 25 - 36, which equates to Weeks 97-144.
494918|NCT00721123|O2|Outcome|Months 13 − 24|Participants with scores during Months 13 − 24, which equates to Weeks 49-96.
494919|NCT00721123|O1|Outcome|Months 0 - 12|Participants with scores during Months 0-12, which equates to baseline through Week 48.
494920|NCT00721123|E1|Reported Event|Tocilizumab 8 mg/kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
494921|NCT00721136|B5|Baseline|Total|Total of all reporting groups
494922|NCT00721136|B4|Baseline|High Risk Holding Warfarin|These high risk patients randomized to holding coumadin for 4-5 days and using a heparin transition for bridging.
494923|NCT00721136|B3|Baseline|High Risk Continuing Warfarin|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue coumadin at the usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
494924|NCT00721136|B2|Baseline|Moderate Risk Holding Warfarin|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
494925|NCT00721136|B1|Baseline|Moderate Risk Continuing Warfarin|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
494926|NCT00721136|P4|Participant Flow|High Risk Holding Warfarin (Coumadin)|These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
494991|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494927|NCT00721136|P3|Participant Flow|High Risk Continuing Warfarin (Coumadin)|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
494928|NCT00721136|P2|Participant Flow|Moderate Risk Holding Warfarin (Coumadin)|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
494929|NCT00721136|P1|Participant Flow|Moderate Risk Continuing Warfarin (Coumadin)|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
494930|NCT00721136|O4|Outcome|High Risk Holding Warfarin (Coumadin)|These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
494931|NCT00721136|O3|Outcome|High Risk Continuing Warfarin (Coumadin)|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
494932|NCT00721136|O2|Outcome|Moderate Risk Holding Warfarin (Coumadin)|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
494933|NCT00721136|O1|Outcome|Moderate Risk Continuing Warfarin (Coumadin)|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
494934|NCT00721136|O4|Outcome|High Risk Holding Warfarin (Coumadin)|These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
494935|NCT00721136|O3|Outcome|High Risk Continuing Warfarin (Coumadin)|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
494936|NCT00721136|O2|Outcome|Moderate Risk Holding Warfarin (Coumadin)|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
494937|NCT00721136|O1|Outcome|Moderate Risk Continuing Warfarin (Coumadin)|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
494938|NCT00721136|O4|Outcome|High Risk Holding Warfarin|These high risk patients randomized to holding warfarin for 4-
494939|NCT00721136|O3|Outcome|High Risk Continuing Warfarin|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
These patients continue warfarin through the procedure: The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
494940|NCT00721136|O2|Outcome|Moderate Risk Holding Warfarin|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
494941|NCT00721136|O1|Outcome|Moderate Risk Continuing Warfarin|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure:The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
494942|NCT00721136|E4|Reported Event|High Risk Holding Warfarin|"These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging."
494943|NCT00721136|E3|Reported Event|High Risk Continuing Warfarin|High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
494944|NCT00721136|E2|Reported Event|Moderate Risk Holding Warfarin|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
494945|NCT00721136|E1|Reported Event|Moderate Risk Continuing Warfarin|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
494946|NCT00721149|B1|Baseline|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
494947|NCT00721149|P1|Participant Flow|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
494948|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
494992|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494949|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
494950|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
494951|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
494952|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
494953|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
494954|NCT00721149|E1|Reported Event|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
494955|NCT00721162|B1|Baseline|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
494956|NCT00721162|P1|Participant Flow|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
494957|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
494958|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
494959|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
494960|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
494961|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
494962|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
494963|NCT00721162|E1|Reported Event|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
494964|NCT00721175|B3|Baseline|Total|Total of all reporting groups
494965|NCT00721175|B2|Baseline|Plastic Stent|plastic stent group
494966|NCT00721175|B1|Baseline|SEMS|self-expandable metal stent group
494967|NCT00721175|P2|Participant Flow|Plastic Stent|plastic stent group
494968|NCT00721175|P1|Participant Flow|SEMS|self-expandable metal stent group
494969|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
494970|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
494971|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
494972|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
494973|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
494974|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
494975|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
494976|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
494978|NCT00721175|E1|Reported Event|SEMS|self-expandable metal stent group
494979|NCT00721188|B1|Baseline|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494980|NCT00721188|P1|Participant Flow|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494981|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494982|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494983|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494984|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494985|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494986|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494987|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494988|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494989|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494990|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
495539|NCT00723801|O2|Outcome|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
494993|NCT00721188|E1|Reported Event|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
494994|NCT00721214|B1|Baseline|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
494995|NCT00721214|P1|Participant Flow|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
494996|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
494997|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
494998|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
494999|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
495000|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
495001|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
495002|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
495003|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
495004|NCT00721214|E1|Reported Event|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.
5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
495005|NCT00721227|B3|Baseline|Total|Total of all reporting groups
495006|NCT00721227|B2|Baseline|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
495007|NCT00721227|B1|Baseline|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
495008|NCT00721227|P2|Participant Flow|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
495009|NCT00721227|P1|Participant Flow|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
495010|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
495011|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
495012|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
495013|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
495014|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
495015|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
495016|NCT00721227|E2|Reported Event|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
495017|NCT00721227|E1|Reported Event|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
495018|NCT00722553|B1|Baseline|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
495019|NCT00722553|P1|Participant Flow|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
495020|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
495021|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
495022|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
495023|NCT00722553|O1|Outcome|Evaluable Patients|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
495024|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed transitional cell carcinoma (TCC) (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
495025|NCT00722553|E1|Reported Event|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
495026|NCT00722566|B3|Baseline|Total|Total of all reporting groups
495027|NCT00722566|B2|Baseline|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
495028|NCT00722566|B1|Baseline|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
495029|NCT00722566|P2|Participant Flow|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
495030|NCT00722566|P1|Participant Flow|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
495031|NCT00722566|O2|Outcome|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
495032|NCT00722566|O1|Outcome|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
495033|NCT00722566|O2|Outcome|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
495034|NCT00722566|O1|Outcome|VELCADE Subcutaneuous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
495035|NCT00722566|E2|Reported Event|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
495036|NCT00722566|E1|Reported Event|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
495037|NCT00722722|B4|Baseline|Total|Total of all reporting groups
495038|NCT00722722|B3|Baseline|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495039|NCT00722722|B2|Baseline|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495040|NCT00722722|B1|Baseline|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495041|NCT00722722|P3|Participant Flow|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495042|NCT00722722|P2|Participant Flow|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495043|NCT00722722|P1|Participant Flow|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495044|NCT00722722|O3|Outcome|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495045|NCT00722722|O2|Outcome|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495046|NCT00722722|O1|Outcome|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495047|NCT00722722|E3|Reported Event|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495048|NCT00722722|E2|Reported Event|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495049|NCT00722722|E1|Reported Event|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)
Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
495050|NCT00722761|B3|Baseline|Total|Total of all reporting groups
495051|NCT00722761|B2|Baseline|Placebo Tablet|Placebo tablet once a day
495052|NCT00722761|B1|Baseline|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
495053|NCT00722761|P2|Participant Flow|Placebo Tablet|Placebo tablet once a day
495054|NCT00722761|P1|Participant Flow|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
495055|NCT00722761|O2|Outcome|Placebo Tablet|Placebo tablet once a day
495056|NCT00722761|O1|Outcome|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
495057|NCT00722761|O2|Outcome|Placebo Tablet|Placebo tablet once a day
495058|NCT00722761|O1|Outcome|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
495059|NCT00722761|E2|Reported Event|Placebo Tablet|Placebo tablet once a day
495060|NCT00722761|E1|Reported Event|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
495061|NCT00722800|B3|Baseline|Total|Total of all reporting groups
495062|NCT00722800|B2|Baseline|Placebo Tablets|Placebo tablet once a day for 6 months
495063|NCT00722800|B1|Baseline|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
495064|NCT00722800|P2|Participant Flow|Placebo Tablets|Placebo tablet once a day for 6 months
495065|NCT00722800|P1|Participant Flow|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
495066|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
495067|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
495068|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
495069|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
495070|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
495071|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
495072|NCT00722800|E2|Reported Event|Placebo Tablets|Placebo tablet once a day for 6 months
495073|NCT00722800|E1|Reported Event|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
495074|NCT00722865|B1|Baseline|Avastin (Bevacizumab)|"single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
495075|NCT00722865|P1|Participant Flow|Avastin (Bevacizumab)|"single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
495076|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
495077|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
495078|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
495079|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
495080|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
495081|NCT00722865|E1|Reported Event|Avastin (Bevacizumab)|"single-arm, open-label
Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
495082|NCT00723008|B3|Baseline|Total|Total of all reporting groups
495083|NCT00723008|B2|Baseline|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495140|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
495084|NCT00723008|B1|Baseline|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495085|NCT00723008|P2|Participant Flow|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495086|NCT00723008|P1|Participant Flow|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495087|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495088|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495089|NCT00723008|O4|Outcome|Group B: AFTER Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
495090|NCT00723008|O3|Outcome|Group B: BEFORE Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
495091|NCT00723008|O2|Outcome|Group A: AFTER CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
495092|NCT00723008|O1|Outcome|Group A: BEFORE CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
495093|NCT00723008|O4|Outcome|Group B: AFTER Sham or CES Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
495094|NCT00723008|O3|Outcome|Group B: BEFORE Sham or CES Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
495095|NCT00723008|O2|Outcome|Group A: AFTER CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
495096|NCT00723008|O1|Outcome|Group A: BEFORE CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
495097|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495098|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495099|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495100|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495141|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
495101|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495102|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.
Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
495103|NCT00723008|E4|Reported Event|Group B: Unblinded Phase|Subjects Previously receiving sham device, now using active Alpha Stim device with settings at the patient's preference (1 to 6/6), one hour per day for 5 days per week for 4 weeks.
495104|NCT00723008|E3|Reported Event|Group B: Blinded Phase|Subjects receiving sham CES treatment for 1 hour daily for 4 weeks.
495105|NCT00723008|E2|Reported Event|Group A: Unblinded Phase|Subjects using Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6).
495106|NCT00723008|E1|Reported Event|Group A: Blinded Phase|Subjects receiving double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) for one hour daily.
495107|NCT00723021|B1|Baseline|All Participants|Participants receiving any of the 5 treatments (PF-04191834 30 mg, PF-04191834 100 mg, PF-04191834 2000 mg, Zileuton CR 1200 mg and Placebo) in a randomized fashion first
495108|NCT00723021|P5|Participant Flow|Treatment Sequence 5|Zileuton CR 1200 mg/PF-04191834 2000 mg/Placebo/PF-04191834 100 mg/PF-04191834 30 mg
495109|NCT00723021|P4|Participant Flow|Treatment Sequence 4|PF-04191834 30 mg/Placebo/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 2000 mg
495110|NCT00723021|P3|Participant Flow|Treatment Sequence 3|PF-04191834 2000 mg/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 30 mg/Placebo
495111|NCT00723021|P2|Participant Flow|Treatment Sequence 2|PF-04191834 100 mg/PF-04191834 30 mg/PF-04191834 2000 mg/Placebo/Zileuton CR 1200 mg
495112|NCT00723021|P1|Participant Flow|Treatment Sequence 1|Placebo/Zileuton CR 1200 mg/PF-04191834 30 mg/PF-04191834 2000 mg/PF-04191834 100 mg
495113|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495114|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
495115|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
495116|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495117|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
495118|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
495119|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495120|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
495121|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
495122|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495123|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
495124|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
495125|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495126|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
495127|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
495128|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
495129|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495130|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
495131|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
495132|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
495133|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Each subject received zileuton CR 1200 mg, 2x600 mg tablets, single dose + placebo oral dispersion, single dose
495134|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495135|NCT00723021|O3|Outcome|PF-04191834 100 mg|Each subject received PF-04191834 100 mg, single dose, oral disersion + 2 x placebo tablets, single dose
495136|NCT00723021|O2|Outcome|PF-04191834 30 mg|Each subject received PF-04191834 30 mg, single dose, oral dispersion + 2 x placebo tablets
495137|NCT00723021|O1|Outcome|Placebo|Each subject received 2 x placebo tablets ( for zileuton 600 mg tablets) + placebo oral dispersion (for PF-04191834), single dose
495138|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
495139|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495142|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
495143|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Each subject received zileuton CR 1200 mg, 2x600 mg tablets, single dose + placebo oral dispersion, single dose
495144|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495145|NCT00723021|O3|Outcome|PF-04191834 100 mg|Each subject received PF-04191834 100 mg, single dose, oral disersion + 2 x placebo tablets, single dose
495146|NCT00723021|O2|Outcome|PF-04191834 30 mg|Each subject received PF-04191834 30 mg, single dose, oral dispersion + 2 x placebo tablets
495147|NCT00723021|O1|Outcome|Placebo|Each subject received 2 x placebo tablets ( for zileuton 600 mg tablets) + placebo oral dispersion (for PF-04191834), single dose
495148|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
495149|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495150|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
495151|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
495152|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
495153|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
495154|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495155|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
495156|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
495540|NCT00723801|O1|Outcome|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
495157|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
495158|NCT00723021|E5|Reported Event|Zileuton CR 1200 mg|Paticipants received single oral dose of zileuton CR1200 mg (2 x 600 mg tablets) in any treatment period
495159|NCT00723021|E4|Reported Event|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
495160|NCT00723021|E3|Reported Event|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
495161|NCT00723021|E2|Reported Event|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
495162|NCT00723021|E1|Reported Event|Placebo|Participants received single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
495163|NCT00723073|B3|Baseline|Total|Total of all reporting groups
495164|NCT00723073|B2|Baseline|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495165|NCT00723073|B1|Baseline|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495166|NCT00723073|P2|Participant Flow|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495167|NCT00723073|P1|Participant Flow|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495168|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495169|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495170|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495171|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495172|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495173|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495174|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495175|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495176|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495177|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495178|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495179|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495180|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495181|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495182|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495183|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495184|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495185|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495186|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495187|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495188|NCT00723073|E2|Reported Event|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
495189|NCT00723073|E1|Reported Event|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
495190|NCT00723125|B3|Baseline|Total|Total of all reporting groups
495191|NCT00723125|B2|Baseline|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks
Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
495192|NCT00723125|B1|Baseline|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks
Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
495193|NCT00723125|P2|Participant Flow|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks
Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
495194|NCT00723125|P1|Participant Flow|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks
Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
495195|NCT00723125|O2|Outcome|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks
Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
495196|NCT00723125|O1|Outcome|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks
Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
495197|NCT00723125|E6|Reported Event|Cohort 2 Adjuvant Post Surgery|Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks
495740|NCT00724594|E3|Reported Event|NAC Maternal|Mothers of infants treated with N-acetylcysteine
495198|NCT00723125|E5|Reported Event|Cohort 1 Adjuvant Post Surgery|Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks
495199|NCT00723125|E4|Reported Event|Cohort 2 DDAC|Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles
495200|NCT00723125|E3|Reported Event|Cohort 1 DDAC|Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles
495201|NCT00723125|E2|Reported Event|Cohort 2 Neo-adjuvant|Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)
495202|NCT00723125|E1|Reported Event|Cohort 1 Neo-adjuvant|Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10
495203|NCT00723177|B4|Baseline|Total|Total of all reporting groups
495204|NCT00723177|B3|Baseline|High-dose AV411|"This group will receive a high dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495205|NCT00723177|B2|Baseline|Low-dose AV411|"This group will receive a low dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495206|NCT00723177|B1|Baseline|Placebo|"This group will receive placebo AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495207|NCT00723177|P3|Participant Flow|High-dose AV411|"This group will receive a high dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
495208|NCT00723177|P2|Participant Flow|Low-dose AV411|"This group will receive a low dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
495209|NCT00723177|P1|Participant Flow|Placebo|"This group received placebo AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
495210|NCT00723177|O3|Outcome|High-dose AV411|"This group will receive a high dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495211|NCT00723177|O2|Outcome|Low-dose AV411|"This group will receive a low dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495212|NCT00723177|O1|Outcome|Placebo|"This group will receive placebo AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495213|NCT00723177|O3|Outcome|High-dose AV411|"This group will receive a high dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495214|NCT00723177|O2|Outcome|Low-dose AV411|"This group will receive a low dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495215|NCT00723177|O1|Outcome|Placebo|"This group will receive placebo AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495216|NCT00723177|E3|Reported Event|High-dose AV411|"This group will receive a high dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495217|NCT00723177|E2|Reported Event|Low-dose AV411|"This group will receive a low dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495218|NCT00723177|E1|Reported Event|Placebo|"This group will receive placebo AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
495219|NCT00723190|B1|Baseline|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495220|NCT00723190|P1|Participant Flow|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495221|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495222|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495223|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495224|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495225|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495226|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495227|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495228|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495229|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495741|NCT00724594|E2|Reported Event|Control Infant|Infants treated with saline
495230|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495231|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495232|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495233|NCT00723190|E1|Reported Event|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
495234|NCT00723203|B1|Baseline|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
gene expression analysis: Day 1 and day 28 samples
reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples
laboratory biomarker analysis: Day 1 and day 28 samples"
495235|NCT00723203|P1|Participant Flow|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
gene expression analysis: Day 1 and day 28 samples
reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples
laboratory biomarker analysis: Day 1 and day 28 samples"
495308|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495541|NCT00723801|E2|Reported Event|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
495236|NCT00723203|O1|Outcome|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
gene expression analysis: Day 1 and day 28 samples
reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples
laboratory biomarker analysis: Day 1 and day 28 samples"
495237|NCT00723203|E1|Reported Event|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
gene expression analysis: Day 1 and day 28 samples
reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples
laboratory biomarker analysis: Day 1 and day 28 samples"
495238|NCT00723229|B3|Baseline|Total|Total of all reporting groups
495239|NCT00723229|B2|Baseline|Acyclovir 400 mg Twice Daily|
495240|NCT00723229|B1|Baseline|No Medication|
495241|NCT00723229|P2|Participant Flow|Acyclovir 400 mg Twice Daily First, Followed by no Medication|Acyclovir 400 mg twice daily for 4 weeks, then 1 week washout, followed by no medication for 4 weeks
495242|NCT00723229|P1|Participant Flow|No Medication First, Then Standard-dose Acyclovir|No medication for 4 weeks, then 1 week washout, followed by acyclovir 400 mg twice daily for 4 weeks
495243|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
495244|NCT00723229|O1|Outcome|No Medication|
495245|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
495246|NCT00723229|O1|Outcome|No Medication|
495247|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
495248|NCT00723229|O1|Outcome|No Medication|
495249|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
495250|NCT00723229|O1|Outcome|No Medication|
495251|NCT00723229|E2|Reported Event|Acyclovir 400 mg Twice Daily|
495252|NCT00723229|E1|Reported Event|No Medication|
495253|NCT00723255|B1|Baseline|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
495254|NCT00723255|P1|Participant Flow|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
495255|NCT00723255|O2|Outcome|Grade 3|Patients with grade 3 tumors (patients with missing grade excluded, n=7)
495256|NCT00723255|O1|Outcome|Grade 1,2|Patients with grade 1-2 tumors (patients with missing grade excluded, n=7)
495257|NCT00723255|O2|Outcome|Grade 3|Patients with grade 3 tumors (patients with missing grade excluded, n=7)
495258|NCT00723255|O1|Outcome|Grade 1,2|Patients with grade 1-2 tumors (patients with missing grade excluded, n=7)
495259|NCT00723255|O2|Outcome|Other Histologic Types|Patients with other histologic types, including benign (not otherwise specified) (n=1), unspecified adenocarcinoma (n=1), clear cell carcinoma (n=2), mucinous adenocarcinoma (n=1), mixed epithelial carcinoma (n=5), undifferentiated carcinoma (n=1), serous adenocarcinoma (n=4)
495260|NCT00723255|O1|Outcome|Endometrioid Adenocarcinoma|Patients with endometrioid adenocarcinoma
495261|NCT00723255|O2|Outcome|Other Histologic Types|Patients with other histologic types, including benign (not otherwise specified) (n=1), unspecified adenocarcinoma (n=1), clear cell carcinoma (n=2), mucinous adenocarcinoma (n=1), mixed epithelial carcinoma (n=5), undifferentiated carcinoma (n=1), serous adenocarcinoma (n=4)
495262|NCT00723255|O1|Outcome|Endometrioid Adenocarcinoma|Patients with endometrioid adenocarcinoma
495263|NCT00723255|O2|Outcome|Performance Status 1,2|Patients with performance status 1 or 2 Performance Status 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work Performance Status 2: Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours
495264|NCT00723255|O1|Outcome|Performance Status 0|Patients with performance status 0 Performance Status 0: Fully active, able to carry on all pre-disease performance without restriction
495265|NCT00723255|O2|Outcome|Performance Status 1,2|Patients with performance status 1 or 2 Performance Status 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work Performance Status 2: Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours
498787|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
495266|NCT00723255|O1|Outcome|Performance Status 0|Patients with performance status 0 Performance Status 0: Fully active, able to carry on all pre-disease performance without restriction
495267|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
495268|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
495269|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
495270|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
495271|NCT00723255|E1|Reported Event|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
495272|NCT00723294|B1|Baseline|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
495310|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495273|NCT00723294|P1|Participant Flow|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
495274|NCT00723294|O1|Outcome|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
495275|NCT00723294|O1|Outcome|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
495276|NCT00723294|E1|Reported Event|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
495277|NCT00723450|B3|Baseline|Total|Total of all reporting groups
495278|NCT00723450|B2|Baseline|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495279|NCT00723450|B1|Baseline|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495280|NCT00723450|P3|Participant Flow|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495281|NCT00723450|P2|Participant Flow|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495282|NCT00723450|P1|Participant Flow|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
495283|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495284|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495285|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
495286|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495287|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495742|NCT00724594|E1|Reported Event|NAC Infant|Infants treated with N-acetylcysteine
495288|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
495289|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495290|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495309|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495419|NCT00723528|E3|Reported Event|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495291|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
495292|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495293|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495294|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
495295|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495296|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495297|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
495298|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495299|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495300|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
495301|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495302|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495303|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
495304|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495743|NCT00724698|B1|Baseline|Desloratadine|Desloratadine 5 mg daily
495305|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495306|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
495307|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495311|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495312|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495313|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495314|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495315|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495316|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495317|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495318|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
495319|NCT00723450|E3|Reported Event|Randomized and Double-blind Taper Phases: LTG|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Randomized Phase.
495320|NCT00723450|E2|Reported Event|Randomized and Double-blind Taper Phases: Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks. The participant received Placebo during this Phase.
495321|NCT00723450|E1|Reported Event|Open-Label and Open-Label Taper Phases: LTG|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks. Participants discontinuing from the study during the Open-Label Phase entered an open Taper and Follow-up Phase.The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Open-Label Phase.
495322|NCT00723489|B5|Baseline|Total|Total of all reporting groups
495323|NCT00723489|B4|Baseline|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495324|NCT00723489|B3|Baseline|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495325|NCT00723489|B2|Baseline|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
495326|NCT00723489|B1|Baseline|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
495327|NCT00723489|P4|Participant Flow|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495328|NCT00723489|P3|Participant Flow|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495329|NCT00723489|P2|Participant Flow|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
495420|NCT00723528|E2|Reported Event|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495542|NCT00723801|E1|Reported Event|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
495330|NCT00723489|P1|Participant Flow|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
495331|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495332|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495333|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
495334|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
495335|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495336|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495337|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
495338|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
495339|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
495340|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
495341|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495342|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495343|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
495413|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495344|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
495345|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495346|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495347|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
495348|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
520295|NCT00783692|B4|Baseline|Total|Total of all reporting groups
495349|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495350|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495351|NCT00723489|E4|Reported Event|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495352|NCT00723489|E3|Reported Event|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
495353|NCT00723489|E2|Reported Event|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
495354|NCT00723489|E1|Reported Event|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
495355|NCT00723528|B4|Baseline|Total|Total of all reporting groups
495356|NCT00723528|B3|Baseline|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495357|NCT00723528|B2|Baseline|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495358|NCT00723528|B1|Baseline|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
495359|NCT00723528|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
495360|NCT00723528|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
495361|NCT00723528|P5|Participant Flow|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495362|NCT00723528|P4|Participant Flow|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495363|NCT00723528|P3|Participant Flow|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495364|NCT00723528|P2|Participant Flow|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495365|NCT00723528|P1|Participant Flow|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
495366|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
495414|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
495367|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
495368|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
495369|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495370|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495371|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495372|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
495421|NCT00723528|E1|Reported Event|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
495373|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
495374|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
495375|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
495376|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495377|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
495378|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
495379|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
495380|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495381|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
495382|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
495383|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
495384|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495385|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
495386|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
495387|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
495388|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495389|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
495390|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
495391|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
495392|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495393|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
495422|NCT00723554|B1|Baseline|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495394|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
495395|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
495396|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495397|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
495398|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
495399|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
495400|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495401|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
495402|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
495403|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
495404|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495405|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
495406|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
495407|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
495408|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495409|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495410|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495411|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
495412|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
495679|NCT00724347|O1|Outcome|Training Group|Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
495415|NCT00723528|E7|Reported Event|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
495416|NCT00723528|E6|Reported Event|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
495417|NCT00723528|E5|Reported Event|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
495418|NCT00723528|E4|Reported Event|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
495423|NCT00723554|P1|Participant Flow|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495424|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
495425|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
495426|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495427|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495428|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
495429|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495430|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495431|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495432|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495433|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
495434|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495435|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495436|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495437|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
495438|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495439|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495440|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495441|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
495442|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495443|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495444|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495445|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
495446|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495447|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495448|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495449|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
495450|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495451|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495452|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495453|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495454|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
495455|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495456|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495457|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495458|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495459|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
495460|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
522792|NCT00795366|B3|Baseline|Total|Total of all reporting groups
495461|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
495462|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495463|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495464|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
495465|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495466|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495467|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495468|NCT00723554|E1|Reported Event|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
495469|NCT00723580|B1|Baseline|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
495470|NCT00723580|P1|Participant Flow|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
495471|NCT00723580|O1|Outcome|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
495494|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
495495|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
495472|NCT00723580|E1|Reported Event|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
495473|NCT00723606|B3|Baseline|Total|Total of all reporting groups
495474|NCT00723606|B2|Baseline|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
495475|NCT00723606|B1|Baseline|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
495476|NCT00723606|P2|Participant Flow|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
495534|NCT00723801|B1|Baseline|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
495535|NCT00723801|P2|Participant Flow|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
495477|NCT00723606|P1|Participant Flow|Ziprasidone|An initial intramuscular (IM) injection of ziprasidone 10 or 20 milligram (mg). Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours possible treatment.
495478|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
495479|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
495480|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
495481|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
495482|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
495483|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
495484|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
495485|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
495486|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
495487|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
495488|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
495489|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
495490|NCT00723606|E2|Reported Event|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
495491|NCT00723606|E1|Reported Event|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
495492|NCT00723632|B1|Baseline|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
495493|NCT00723632|P1|Participant Flow|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
495678|NCT00724347|P1|Participant Flow|Arm 1|PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
495496|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
495497|NCT00723632|E1|Reported Event|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
495498|NCT00723645|B1|Baseline|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
495499|NCT00723645|P1|Participant Flow|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
495500|NCT00723645|O1|Outcome|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
495536|NCT00723801|P1|Participant Flow|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
495501|NCT00723645|O1|Outcome|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
495502|NCT00723645|E1|Reported Event|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
495503|NCT00723697|B1|Baseline|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
495504|NCT00723697|P1|Participant Flow|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
495505|NCT00723697|O1|Outcome|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
495506|NCT00723697|O3|Outcome|Patients at 12 Month Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
495507|NCT00723697|O2|Outcome|Patients at 6 Month Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
495508|NCT00723697|O1|Outcome|Patients at First Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
495509|NCT00723697|O1|Outcome|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
495510|NCT00723697|E1|Reported Event|Patients|
495511|NCT00723710|B1|Baseline|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
495512|NCT00723710|P1|Participant Flow|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m^2). The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
495513|NCT00723710|O1|Outcome|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
495514|NCT00723710|E1|Reported Event|Intron-A|
495515|NCT00723736|B1|Baseline|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
495516|NCT00723736|P1|Participant Flow|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
495517|NCT00723736|O1|Outcome|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
495518|NCT00723736|E1|Reported Event|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
495519|NCT00723749|B1|Baseline|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
495520|NCT00723749|P1|Participant Flow|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
495521|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
495522|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
495523|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
495524|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
495525|NCT00723749|E1|Reported Event|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
495526|NCT00723788|B1|Baseline|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
495527|NCT00723788|P1|Participant Flow|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
495528|NCT00723788|O3|Outcome|CT of the Abdomen|All patients enrolled received an MRI followed in some cases by computed tomography.
495529|NCT00723788|O2|Outcome|US of the Abdomen|All patients enrolled received an MRI followed in some cases by ultrasund.
495530|NCT00723788|O1|Outcome|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
495531|NCT00723788|E1|Reported Event|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
495532|NCT00723801|B3|Baseline|Total|Total of all reporting groups
495533|NCT00723801|B2|Baseline|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
495543|NCT00723827|B1|Baseline|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
495544|NCT00723827|P1|Participant Flow|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
495545|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
495546|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
495547|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
495548|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
495549|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
495550|NCT00723827|E1|Reported Event|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
495551|NCT00723840|B1|Baseline|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6
months, who have a Crohn's Disease Activity Index
(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below
indicates remission and a score above 450 indicates extremely severe disease."
495738|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
495552|NCT00723840|P1|Participant Flow|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6
months, who have a Crohn's Disease Activity Index
(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below
indicates remission and a score above 450 indicates extremely severe disease."
495553|NCT00723840|O4|Outcome|18 Months|QoL scores per participant at 18 months
495554|NCT00723840|O3|Outcome|12 Months|QoL scores per participant at 12 months
495555|NCT00723840|O2|Outcome|6 Months|QoL scores per participant at 6 months
495556|NCT00723840|O1|Outcome|Baseline|QoL scores per participant at baseline
495557|NCT00723840|O4|Outcome|18 Months|Costs per participant at 18 months in Euros
495558|NCT00723840|O3|Outcome|12 Months|Costs per participant at 12 months in Euros
495559|NCT00723840|O2|Outcome|6 Months|Costs per participant at 6 months in Euros
495560|NCT00723840|O1|Outcome|Baseline|Costs per participant at baseline in Euros
495561|NCT00723840|E1|Reported Event|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6
months, who have a Crohn's Disease Activity Index
(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below
indicates remission and a score above 450 indicates extremely severe disease."
495562|NCT00723892|B3|Baseline|Total|Total of all reporting groups
495563|NCT00723892|B2|Baseline|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
495564|NCT00723892|B1|Baseline|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
495565|NCT00723892|P2|Participant Flow|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
495566|NCT00723892|P1|Participant Flow|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
495567|NCT00723892|O2|Outcome|PegIntron/Rebetol Alone (no Psychotherapy|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
495568|NCT00723892|O1|Outcome|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
495569|NCT00723892|O2|Outcome|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
495570|NCT00723892|O1|Outcome|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
495571|NCT00723892|E1|Reported Event|All Enrolled Participants|
495572|NCT00723931|B1|Baseline|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
495573|NCT00723931|P1|Participant Flow|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
495574|NCT00723931|O1|Outcome|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
495575|NCT00723931|O1|Outcome|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
495576|NCT00723931|E1|Reported Event|Pegintron/Pegintron Redipen Injection|
495577|NCT00723944|B3|Baseline|Total|Total of all reporting groups
495578|NCT00723944|B2|Baseline|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
495579|NCT00723944|B1|Baseline|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
495580|NCT00723944|P2|Participant Flow|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
495581|NCT00723944|P1|Participant Flow|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
495582|NCT00723944|O2|Outcome|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
495583|NCT00723944|O1|Outcome|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
495584|NCT00723944|E2|Reported Event|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
495585|NCT00723944|E1|Reported Event|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
495586|NCT00723957|B3|Baseline|Total|Total of all reporting groups
495587|NCT00723957|B2|Baseline|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495588|NCT00723957|B1|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495589|NCT00723957|P2|Participant Flow|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495590|NCT00723957|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495739|NCT00724594|E4|Reported Event|Control Maternal|Mothers of infants treated with saline
495591|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495592|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495593|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495594|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495595|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495596|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495597|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495598|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495599|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495600|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495601|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495602|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495603|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495604|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495605|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495606|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495607|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495608|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495609|NCT00723957|E2|Reported Event|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
495610|NCT00723957|E1|Reported Event|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
495656|NCT00724152|E3|Reported Event|Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
495611|NCT00724009|B1|Baseline|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
495612|NCT00724009|P1|Participant Flow|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
495613|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
495614|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
495615|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
495616|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
495617|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
495618|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
495619|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
495620|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
495677|NCT00724347|B1|Baseline|Training Group|Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
495621|NCT00724009|E1|Reported Event|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
495622|NCT00724061|B1|Baseline|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
495623|NCT00724061|P1|Participant Flow|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
495624|NCT00724061|O1|Outcome|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
495625|NCT00724061|E1|Reported Event|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
495626|NCT00724126|B3|Baseline|Total|Total of all reporting groups
495627|NCT00724126|B2|Baseline|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
495628|NCT00724126|B1|Baseline|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
495629|NCT00724126|P2|Participant Flow|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
495630|NCT00724126|P1|Participant Flow|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
495631|NCT00724126|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
495632|NCT00724126|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
495633|NCT00724126|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
523104|NCT00783263|B5|Baseline|Total|Total of all reporting groups
495634|NCT00724126|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
495635|NCT00724126|E2|Reported Event|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
495636|NCT00724126|E1|Reported Event|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
495637|NCT00724152|B6|Baseline|Total|Total of all reporting groups
495638|NCT00724152|B5|Baseline|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
495639|NCT00724152|B4|Baseline|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
495640|NCT00724152|B3|Baseline|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp randomize.
495641|NCT00724152|B2|Baseline|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
495642|NCT00724152|B1|Baseline|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp randomize.
495643|NCT00724152|P3|Participant Flow|Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
495644|NCT00724152|P2|Participant Flow|Arm 2/Tinnitus Education|"Participants randomly assigned to this group received six weeks of tinnitus education.
Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources."
495645|NCT00724152|P1|Participant Flow|Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
495646|NCT00724152|O5|Outcome|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
495647|NCT00724152|O4|Outcome|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
495648|NCT00724152|O3|Outcome|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp random.
495911|NCT00724893|O3|Outcome|64 to <75 kg|Participants with weight 64 to <75 kg
495649|NCT00724152|O2|Outcome|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
495650|NCT00724152|O1|Outcome|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp random.
495651|NCT00724152|O5|Outcome|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
495652|NCT00724152|O4|Outcome|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
495653|NCT00724152|O3|Outcome|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp random.
495654|NCT00724152|O2|Outcome|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
495655|NCT00724152|O1|Outcome|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp random.
495657|NCT00724152|E2|Reported Event|Arm 2/Tinnitus Education|"Participants randomly assigned to this group received six weeks of tinnitus education.
Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment."
495658|NCT00724152|E1|Reported Event|Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
495659|NCT00724243|B1|Baseline|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
495660|NCT00724243|P1|Participant Flow|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
495661|NCT00724243|O1|Outcome|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
495662|NCT00724243|O1|Outcome|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
495663|NCT00724243|E1|Reported Event|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
495912|NCT00724893|O2|Outcome|50 to <64 kg|Participants with weight 50 to <64 kg
495664|NCT00724282|B1|Baseline|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days
Placebo: Placebo by mouth daily at bedtime for 9 days"
495665|NCT00724282|P1|Participant Flow|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days
Placebo: Placebo by mouth daily at bedtime for 9 days"
495666|NCT00724282|O1|Outcome|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days
Placebo: Placebo by mouth daily at bedtime for 9 days"
495667|NCT00724282|E1|Reported Event|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days
Placebo: Placebo by mouth daily at bedtime for 9 days"
495668|NCT00724308|B3|Baseline|Total|Total of all reporting groups
495669|NCT00724308|B2|Baseline|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
495670|NCT00724308|B1|Baseline|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
495671|NCT00724308|P2|Participant Flow|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
495672|NCT00724308|P1|Participant Flow|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
495673|NCT00724308|O2|Outcome|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
495674|NCT00724308|O1|Outcome|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
495675|NCT00724308|E2|Reported Event|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
495676|NCT00724308|E1|Reported Event|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
495680|NCT00724347|E1|Reported Event|Arm 1|PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
495681|NCT00724373|B1|Baseline|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
495682|NCT00724373|P1|Participant Flow|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
495683|NCT00724373|O1|Outcome|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
495684|NCT00724373|E1|Reported Event|Pegylated Interferon Alfa-2b and Ribavirin|
495685|NCT00724451|B1|Baseline|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
495686|NCT00724451|P1|Participant Flow|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with chronic hepatitis C (CHC) seen in general clinical practice in Italy.
495687|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
495688|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
495689|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
495690|NCT00724451|E1|Reported Event|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
495691|NCT00724464|B1|Baseline|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
495692|NCT00724464|P1|Participant Flow|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
495693|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with Chronic Hepatitis C (CHC) of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype and viral load followed by a 24-week post-treatment follow-up.
495694|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
495695|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
495696|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
495697|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
495698|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
495699|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
495700|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
495701|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with Chronic Hepatitis C (CHC) of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype and viral load followed by a 24-week post-treatment follow-up.
495702|NCT00724464|E1|Reported Event|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
495703|NCT00724477|B1|Baseline|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
495704|NCT00724477|P1|Participant Flow|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
495705|NCT00724477|O1|Outcome|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
495706|NCT00724477|E1|Reported Event|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
495707|NCT00724568|B1|Baseline|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
495708|NCT00724568|P2|Participant Flow|Phase II|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
495709|NCT00724568|P1|Participant Flow|Phase I|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
495710|NCT00724568|O1|Outcome|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
495711|NCT00724568|O1|Outcome|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
495712|NCT00724568|E1|Reported Event|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
495713|NCT00724594|B5|Baseline|Total|Total of all reporting groups
495714|NCT00724594|B4|Baseline|Control Maternal|Mothers of infants treated with saline
495715|NCT00724594|B3|Baseline|NAC Maternal|Mothers of infants treated with N-acetylcysteine
495716|NCT00724594|B2|Baseline|Control Infant|Infants treated with saline
495717|NCT00724594|B1|Baseline|NAC Infant|Infants treated with N-acetylcysteine
495718|NCT00724594|P4|Participant Flow|Control Maternal|Mothers of infants treated with saline
495719|NCT00724594|P3|Participant Flow|NAC Maternal|Mothers of infants treated with N-acetylcysteine
495720|NCT00724594|P2|Participant Flow|Control Infant|Infants treated with saline
495721|NCT00724594|P1|Participant Flow|NAC Infant|Infants treated with N-acetylcysteine
495722|NCT00724594|O4|Outcome|Control Maternal|Mothers treated with saline prior to delivery
495723|NCT00724594|O3|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery
495724|NCT00724594|O2|Outcome|Control Infants|Infants treated with saline
495725|NCT00724594|O1|Outcome|NAC Infants|Infants treated with N-acetylcysteine
495726|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to birth
495727|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
495728|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
495729|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery
495730|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
495731|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
495732|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
495733|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
495734|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
495735|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
495736|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
495737|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
495744|NCT00724698|P1|Participant Flow|Desloratadine|Desloratadine 5 mg daily
495745|NCT00724698|O1|Outcome|Desloratadine|Desloratadine 5 mg daily
495746|NCT00724711|B3|Baseline|Total|Total of all reporting groups
495747|NCT00724711|B2|Baseline|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495748|NCT00724711|B1|Baseline|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495749|NCT00724711|P2|Participant Flow|Abacavir (ABC) /Lamivudine (3TC) + PI/r (Ritonavir-boosted PI)|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495750|NCT00724711|P1|Participant Flow|FTC/TDF (Truvada [TVD]) + PI/r (Ritonavir-boosted PI Regimen)|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495751|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495752|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495753|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495754|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495755|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495756|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495757|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495758|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495759|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495760|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495761|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495762|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495763|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495764|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495765|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495766|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495767|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495768|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495769|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495770|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495771|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495772|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495773|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495774|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495775|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495776|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495777|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495778|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495779|NCT00724711|E2|Reported Event|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
495780|NCT00724711|E1|Reported Event|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
495781|NCT00724750|B3|Baseline|Total|Total of all reporting groups
495782|NCT00724750|B2|Baseline|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.
Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
495783|NCT00724750|B1|Baseline|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
Gauze suction (G-SUC): Negative pressure wound therapy"
495784|NCT00724750|P2|Participant Flow|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.
Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
495785|NCT00724750|P1|Participant Flow|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
Gauze suction (G-SUC): Negative pressure wound therapy"
495786|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.
Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
495787|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
Gauze suction (G-SUC): Negative pressure wound therapy"
495788|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.
Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
495789|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
Gauze suction (G-SUC): Negative pressure wound therapy"
495790|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.
Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
495791|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
Gauze suction (G-SUC): Negative pressure wound therapy"
495792|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.
Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
495793|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
Gauze suction (G-SUC): Negative pressure wound therapy"
495794|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.
Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
495795|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
Gauze suction (G-SUC): Negative pressure wound therapy"
495796|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.
Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
495797|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
Gauze suction (G-SUC): Negative pressure wound therapy"
495798|NCT00724750|E2|Reported Event|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.
Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
495799|NCT00724750|E1|Reported Event|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
Gauze suction (G-SUC): Negative pressure wound therapy"
495800|NCT00724815|B3|Baseline|Total|Total of all reporting groups
495801|NCT00724815|B2|Baseline|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495802|NCT00724815|B1|Baseline|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495870|NCT00724867|E1|Reported Event|Belimumab 10 mg/kg IV|Belimumab 10 mg/kg IV every 28 days
495803|NCT00724815|P2|Participant Flow|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495804|NCT00724815|P1|Participant Flow|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495805|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495806|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495807|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495808|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495809|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495810|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495811|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495812|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495913|NCT00724893|O1|Outcome|40 to <50 kg|Participants with weight 40 to <50 kg
495813|NCT00724815|E2|Reported Event|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495814|NCT00724815|E1|Reported Event|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
495815|NCT00724854|B3|Baseline|Total|Total of all reporting groups
495816|NCT00724854|B2|Baseline|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495817|NCT00724854|B1|Baseline|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495818|NCT00724854|P2|Participant Flow|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495819|NCT00724854|P1|Participant Flow|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495820|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495821|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495822|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495823|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495824|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495825|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495826|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495827|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495828|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495829|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495830|NCT00724854|E3|Reported Event|Not Evaluated|
495831|NCT00724854|E2|Reported Event|Co-Infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495832|NCT00724854|E1|Reported Event|Mono-Infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
495871|NCT00724893|B3|Baseline|Total|Total of all reporting groups
495872|NCT00724893|B2|Baseline|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
496086|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
495833|NCT00724867|B1|Baseline|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
495834|NCT00724867|P1|Participant Flow|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
495835|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495836|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495914|NCT00724893|O3|Outcome|Viral Load Missing|Participants with viral load missing
495915|NCT00724893|O2|Outcome|Viral Load Low|Participants with viral load xxxx
495837|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495838|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495839|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495840|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495841|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495842|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495843|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495844|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495873|NCT00724893|B1|Baseline|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495983|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495845|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495846|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495847|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495848|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495916|NCT00724893|O1|Outcome|Viral Load High|Participants with viral load xxxx
524414|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
495849|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
495850|NCT00724867|O2|Outcome|Belimumab 10 mg/kg IV (Belimumab)|Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
495851|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV (Placebo)|Participants, who had received placebo in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
495852|NCT00724867|O2|Outcome|Belimumab 10 mg/kg IV (Belimumab)|Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
495853|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV (Placebo)|Participants, who had received placebo in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
495854|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495855|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495856|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495874|NCT00724893|P2|Participant Flow|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495984|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495985|NCT00724932|O1|Outcome|Sugammadex Only|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495857|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495858|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495859|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495860|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495861|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495862|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495863|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495864|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495865|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495866|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495867|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495868|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
495869|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
495875|NCT00724893|P1|Participant Flow|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495876|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495877|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495878|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495879|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495880|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495881|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495882|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
525894|NCT00790023|O3|Outcome|Placebo|Placebo once daily
495883|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495884|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495885|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495886|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495887|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495888|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495889|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495890|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495891|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495892|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495893|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495894|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495895|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495896|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495897|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495898|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495899|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495900|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495901|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495902|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495903|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495904|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495905|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495906|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495907|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495908|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495909|NCT00724893|O5|Outcome|>85 kg|Participants with weight >85 kg
495910|NCT00724893|O4|Outcome|75 to <85 kg|Participants with weight 75 to <85 kg
495917|NCT00724893|O6|Outcome|Unknown Stage|Participants with unknown Fibrosis Stage
495918|NCT00724893|O5|Outcome|Stage F4|Participants with Fibrosis Stage F4
495919|NCT00724893|O4|Outcome|Stage F3|Participants with Fibrosis Stage F4
495920|NCT00724893|O3|Outcome|Stage F2|Participants with Fibrosis Stage F2
495921|NCT00724893|O2|Outcome|Stage F1|Participants with Fibrosis Stage F1
495922|NCT00724893|O1|Outcome|Stage F0|Participants with Fibrosis Stage F0
495923|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495924|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495925|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495926|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495927|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495928|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495929|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495930|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495931|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495932|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495933|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495934|NCT00724893|O2|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495935|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495936|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495982|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
496036|NCT00724984|B5|Baseline|Follicular/Phase II|
495937|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495938|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495939|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495940|NCT00724893|E2|Reported Event|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495941|NCT00724893|E1|Reported Event|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
495942|NCT00724932|B3|Baseline|Total|Total of all reporting groups
495943|NCT00724932|B2|Baseline|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495944|NCT00724932|B1|Baseline|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495945|NCT00724932|P2|Participant Flow|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of the second twitch (T2)
495946|NCT00724932|P1|Participant Flow|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 Post Tetanic Count (PTC)
495947|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495948|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495949|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495950|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495951|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495952|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495953|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495954|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495955|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495956|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495957|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495958|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495959|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495960|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495961|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495962|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495963|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495964|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495965|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495966|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495967|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495968|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495969|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495970|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495971|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495972|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495973|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495974|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495975|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495976|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495977|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495978|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495979|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495980|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495981|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495986|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495987|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495988|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495989|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495990|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495991|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495992|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495993|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495994|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495995|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495996|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495997|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
495998|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
495999|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
496000|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
496001|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
496002|NCT00724932|O1|Outcome|Neostigmine Only|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
496003|NCT00724932|O1|Outcome|Sugammadex Only|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
496004|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
496005|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
496006|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
496007|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
496008|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
496009|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
496010|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
496011|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
496012|NCT00724932|E2|Reported Event|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of T2
496013|NCT00724932|E1|Reported Event|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
496014|NCT00724945|B1|Baseline|Overall|The reporting group for baseline characteristics includes all subjects that completed the study wearing contact lenses made from either senofilcon A or balafilcon A material. Excluded are 8 subjects that discontinued and 2 subjects dispensed lenses from outside study contact lens materials.
496015|NCT00724945|P2|Participant Flow|Balafilcon A/Senofilcon A|balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
496016|NCT00724945|P1|Participant Flow|Senofilcon A/Balafilcon A|senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
496017|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
496018|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
496019|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
496020|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
496021|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
496022|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
496023|NCT00724945|E2|Reported Event|Balafilcon A/Senofilcon A|balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
496024|NCT00724945|E1|Reported Event|Senofilcon A/Balafilcon A|senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
496025|NCT00724958|B1|Baseline|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting who received at least one infliximab infusion.
496026|NCT00724958|P1|Participant Flow|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
496027|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
496028|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
496029|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
496030|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
496031|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
496032|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
496033|NCT00724958|E1|Reported Event|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
496034|NCT00724984|B7|Baseline|Total|Total of all reporting groups
496035|NCT00724984|B6|Baseline|Mantle Cell Lymphoma/Phase II|
496059|NCT00725010|B1|Baseline|Planned Temozolomide+Radiotherapy|Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
496060|NCT00725010|P1|Participant Flow|Planned Temozolomide+Radiotherapy|Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
496061|NCT00725010|O2|Outcome|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
496062|NCT00725010|O1|Outcome|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
496101|NCT00718237|P1|Participant Flow|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
572687|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
496063|NCT00725010|O2|Outcome|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
496064|NCT00725010|O1|Outcome|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
496065|NCT00725010|E2|Reported Event|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
496066|NCT00725010|E1|Reported Event|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
496067|NCT00725049|B3|Baseline|Total|Total of all reporting groups
496068|NCT00725049|B2|Baseline|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
496069|NCT00725049|B1|Baseline|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
496070|NCT00725049|P2|Participant Flow|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
496071|NCT00725049|P1|Participant Flow|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
496072|NCT00725049|O2|Outcome|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
496073|NCT00725049|O1|Outcome|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
496074|NCT00725049|E2|Reported Event|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
496075|NCT00725049|E1|Reported Event|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
496076|NCT00718120|B3|Baseline|Total|Total of all reporting groups
496077|NCT00718120|B2|Baseline|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
496078|NCT00718120|B1|Baseline|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
496079|NCT00718120|P2|Participant Flow|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
496080|NCT00718120|P1|Participant Flow|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
496081|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
496082|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
496083|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
496084|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
496085|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
496260|NCT00725270|O2|Outcome|Mifepristone|Patients will be randomized to mifepristone
496087|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
496088|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
496089|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
496090|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
496091|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
496092|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
496093|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
496094|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
496095|NCT00718120|E2|Reported Event|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
496096|NCT00718120|E1|Reported Event|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
496097|NCT00718237|B3|Baseline|Total|Total of all reporting groups
496098|NCT00718237|B2|Baseline|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
496099|NCT00718237|B1|Baseline|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496100|NCT00718237|P2|Participant Flow|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
496102|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study
496103|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
496104|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
496105|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496106|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
496107|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
496108|NCT00718237|E2|Reported Event|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
496109|NCT00718237|E1|Reported Event|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496110|NCT00718302|B3|Baseline|Total|Total of all reporting groups
496111|NCT00718302|B2|Baseline|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
496112|NCT00718302|B1|Baseline|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws.
496113|NCT00718302|P2|Participant Flow|Lateral Plate|Lateral Plate: A metal plate is placed to the side of the broken ankle and is secured with screws
496114|NCT00718302|P1|Participant Flow|Antiglide Plate|Antiglide Plate: A plate is placed behind the broken ankle and secured with screws
496115|NCT00718302|O2|Outcome|Randomized Treatment; Lateral Plate|"Randomized treatment; lateral plate
Lateral Plate: A metal plate is placed to the side of the broken ankle and is secured with screws"
496116|NCT00718302|O1|Outcome|Randomized Treatment; Antiglide Plate|"Randomized treatment; antiglide plate
Antiglide Plate: A plate is placed behind the broken ankle and secured with screws"
496117|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
496118|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
496119|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
496120|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
496121|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
496122|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
496123|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
496124|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
496125|NCT00718302|E2|Reported Event|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
496126|NCT00718302|E1|Reported Event|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
496127|NCT00718315|B4|Baseline|Total|Total of all reporting groups
496201|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496128|NCT00718315|B3|Baseline|Verutex|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496129|NCT00718315|B2|Baseline|Stiemicyn|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496130|NCT00718315|B1|Baseline|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496131|NCT00718315|P3|Participant Flow|Verutex|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496132|NCT00718315|P2|Participant Flow|Stiemicyn|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496133|NCT00718315|P1|Participant Flow|Fisiogel|Participants received erlotinib 150 milligrams (mg) daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496134|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
496135|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496136|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
497350|NCT00721500|O1|Outcome|Narafilcon A (Bilateral)|narafilcon A contact lens worn in both eyes.
496137|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
496138|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496139|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496140|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
496141|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496142|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496143|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
496144|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496145|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496146|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
496147|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496148|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496149|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
496150|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496151|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496152|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
496153|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496256|NCT00725270|B2|Baseline|Mifepristone|Patients will be randomized to mifepristone
496257|NCT00725270|B1|Baseline|Placebo|Patients will be randomized to placebo
496154|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496155|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
496156|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496157|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496158|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
496159|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496160|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496161|NCT00718315|E3|Reported Event|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
496162|NCT00718315|E2|Reported Event|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496163|NCT00718315|E1|Reported Event|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
496164|NCT00718328|B3|Baseline|Total|Total of all reporting groups
496165|NCT00718328|B2|Baseline|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
496166|NCT00718328|B1|Baseline|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
496167|NCT00718328|P2|Participant Flow|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
496168|NCT00718328|P1|Participant Flow|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
496169|NCT00718328|O2|Outcome|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
496170|NCT00718328|O1|Outcome|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
496171|NCT00718328|E2|Reported Event|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
496172|NCT00718328|E1|Reported Event|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
496173|NCT00725075|B4|Baseline|Total|Total of all reporting groups
496174|NCT00725075|B3|Baseline|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496175|NCT00725075|B2|Baseline|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496176|NCT00725075|B1|Baseline|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496177|NCT00725075|P3|Participant Flow|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496178|NCT00725075|P2|Participant Flow|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496179|NCT00725075|P1|Participant Flow|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496180|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496181|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496277|NCT00725361|O1|Outcome|Active|"Ambrisentan
Ambrisentan"
496182|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496183|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496184|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496185|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496186|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496187|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496235|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
572688|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
496188|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496189|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496190|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496191|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496192|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496193|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496194|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496195|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496196|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496197|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496198|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496199|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496200|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496258|NCT00725270|P2|Participant Flow|Mifepristone|Patients will be randomized to mifepristone
496202|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496203|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496204|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496205|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496206|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496207|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496208|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496209|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496210|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496211|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496212|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496213|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496214|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496215|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496216|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496217|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496218|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496219|NCT00725075|E3|Reported Event|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
496220|NCT00725075|E2|Reported Event|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496259|NCT00725270|P1|Participant Flow|Placebo|Patients will be randomized to placebo
496221|NCT00725075|E1|Reported Event|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
496222|NCT00725101|B1|Baseline|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496223|NCT00725101|P1|Participant Flow|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496224|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496225|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496226|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496227|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496228|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496229|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496230|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496231|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496232|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496233|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496234|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496236|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496237|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496238|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496239|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496240|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496241|NCT00725101|E1|Reported Event|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
496242|NCT00725153|B1|Baseline|Overall|All enrolled participants
496243|NCT00725153|P2|Participant Flow|Acuvue 2 / PureVision|Acuvue 2 lenses worn in Period One, PureVision lenses worn in Period Two. Both products worn for 10 hours each.
496244|NCT00725153|P1|Participant Flow|PureVision / Acuvue 2|PureVision lenses worn in Period One, Acuvue 2 lenses worn in Period Two. Both products worn for 10 hours each.
496245|NCT00725153|O2|Outcome|Acuvue 2 Contact Lenses|Acuvue 2 lenses worn 10 hours
496246|NCT00725153|O1|Outcome|PureVision Contact Lenses|PureVision lenses worn 10 hours
496247|NCT00725153|E2|Reported Event|Acuvue 2 Lenses Worn 10 Hours|Acuvue 2 lenses worn 10 hours
496248|NCT00725153|E1|Reported Event|PureVision Lenses Worn 10 Hours|PureVision lenses worn 10 hours
496249|NCT00725205|B1|Baseline|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
496250|NCT00725205|P1|Participant Flow|Peginterferon Alfa-2b and Ribavirin|Previously untreated Chronic Hepatitis C (CHC) participants treated with a treatment regimen of 1.5 micgrograms (mcg)/killogram (kg) Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
496251|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
496252|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
496253|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
496254|NCT00725205|E1|Reported Event|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
496255|NCT00725270|B3|Baseline|Total|Total of all reporting groups
496261|NCT00725270|O1|Outcome|Placebo|Patients will be randomized to placebo
496262|NCT00725270|O2|Outcome|Mifepristone|Patients will be randomized to mifepristone
496263|NCT00725270|O1|Outcome|Placebo|Patients will be randomized to placebo
496264|NCT00725270|E2|Reported Event|Mifepristone|Patients will be randomized to mifepristone
496265|NCT00725270|E1|Reported Event|Placebo|Patients will be randomized to placebo
496266|NCT00725296|B1|Baseline|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
496267|NCT00725296|P1|Participant Flow|Infliximab|Participants with active and progressive psoriatic arthritis (PsA) who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
496293|NCT00727337|O3|Outcome|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
572689|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
496268|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
496269|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
496270|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
496271|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
496272|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
496273|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive psoriatic PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
496274|NCT00725296|E1|Reported Event|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
496275|NCT00725361|B1|Baseline|Active|"Ambrisentan
Ambrisentan"
496276|NCT00725361|P1|Participant Flow|Ambrisentan|5 mg orally daily X 4 weeks then 10 mg daily as tolerated
496284|NCT00727337|B4|Baseline|LACE-DVD|"DVD-based auditory training
Auditory Training with DVD: DVD based Auditory Training"
496285|NCT00727337|B3|Baseline|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
496286|NCT00727337|B2|Baseline|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD
Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
496287|NCT00727337|B1|Baseline|LACE-COMPUTER|"Computer-based auditory training
LACE: Computerized Auditory Training"
496288|NCT00727337|P4|Participant Flow|LACE-DVD|"DVD-based auditory training
Auditory Training with DVD: DVD based Auditory Training"
496289|NCT00727337|P3|Participant Flow|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
496290|NCT00727337|P2|Participant Flow|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD
Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
496291|NCT00727337|P1|Participant Flow|LACE - COMPUTER|"Computer-based auditory training
LACE: Computerized Auditory Training"
496292|NCT00727337|O4|Outcome|LACE-DVD|"DVD-based auditory training
Auditory Training with DVD: DVD based Auditory Training"
496370|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496294|NCT00727337|O2|Outcome|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD
Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
496295|NCT00727337|O1|Outcome|LACE-COMPUTER|"Computer-based auditory training
LACE: Computerized Auditory Training"
496296|NCT00727337|E4|Reported Event|LACE-DVD|"DVD-based auditory training
Auditory Training with DVD: DVD based Auditory Training"
496297|NCT00727337|E3|Reported Event|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
496298|NCT00727337|E2|Reported Event|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD
Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
496299|NCT00727337|E1|Reported Event|LACE-COMPUTER|"Computer-based auditory training
LACE: Computerized Auditory Training"
496300|NCT00727402|B1|Baseline|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
496301|NCT00727402|P1|Participant Flow|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
496302|NCT00727402|O1|Outcome|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
496303|NCT00727402|E1|Reported Event|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
496304|NCT00727506|B7|Baseline|Total|Total of all reporting groups
496305|NCT00727506|B6|Baseline|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496306|NCT00727506|B5|Baseline|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496307|NCT00727506|B4|Baseline|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496308|NCT00727506|B3|Baseline|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496309|NCT00727506|B2|Baseline|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496310|NCT00727506|B1|Baseline|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496311|NCT00727506|P6|Participant Flow|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496312|NCT00727506|P5|Participant Flow|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496313|NCT00727506|P4|Participant Flow|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496314|NCT00727506|P3|Participant Flow|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496315|NCT00727506|P2|Participant Flow|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496316|NCT00727506|P1|Participant Flow|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496317|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496318|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496319|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496320|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496321|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496322|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496323|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496324|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496325|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496326|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496327|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496328|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496329|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496330|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496331|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496332|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
498843|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
496333|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496334|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496335|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496336|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496337|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496338|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496339|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496340|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496341|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496342|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496343|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496344|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496345|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496346|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496347|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496348|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496349|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496350|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496351|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496352|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496353|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496354|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496355|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496356|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496357|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496358|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496468|NCT00727597|O2|Outcome|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
496359|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496360|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496361|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496362|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496363|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496364|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496365|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496366|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496367|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496368|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496369|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496371|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496372|NCT00727506|O1|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496373|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of Afatinib).
496374|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of Afatinib).
496375|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of Afatinib).
496376|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of Afatinib).
496377|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of Afatinib).
496378|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of Afatinib).
496379|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of Afatinib).
496380|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of Afatinib).
496381|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of temozolomide).
496382|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of temozolomide).
496383|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of temozolomide).
496384|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of temozolomide).
496385|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of temozolomide).
496386|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of temozolomide).
496387|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496388|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496389|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496390|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496391|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496392|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496554|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496393|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496394|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496395|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496396|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496397|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496398|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496399|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496400|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496401|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496402|NCT00727506|E6|Reported Event|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part.
498844|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
496403|NCT00727506|E5|Reported Event|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
496404|NCT00727506|E4|Reported Event|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
496405|NCT00727506|E3|Reported Event|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496406|NCT00727506|E2|Reported Event|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496407|NCT00727506|E1|Reported Event|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
496408|NCT00727558|B3|Baseline|Total|Total of all reporting groups
496409|NCT00727558|B2|Baseline|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
496410|NCT00727558|B1|Baseline|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
496411|NCT00727558|P2|Participant Flow|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
496412|NCT00727558|P1|Participant Flow|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
496413|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
496414|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
496415|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
496416|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
496417|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
496418|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
496419|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
496420|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
496421|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
496422|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
496423|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
496424|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
496425|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
496426|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
496427|NCT00727558|E2|Reported Event|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
496428|NCT00727558|E1|Reported Event|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
496429|NCT00727571|B5|Baseline|Total|Total of all reporting groups
496430|NCT00727571|B4|Baseline|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496431|NCT00727571|B3|Baseline|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496432|NCT00727571|B2|Baseline|No CKD or Anemia|CKD is based on estimated GFR, calculated by the MDRD method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496433|NCT00727571|B1|Baseline|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496434|NCT00727571|P4|Participant Flow|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
496467|NCT00727597|O1|Outcome|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
496435|NCT00727571|P3|Participant Flow|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed mobility and physical performance assessments.
496436|NCT00727571|P2|Participant Flow|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed an anemia work-up, and mobility and physical performance assessments.
496437|NCT00727571|P1|Participant Flow|No CKD or Anemia|Chronic kidney disease (CKD) is based on an estimated Glomerular Filtration Rate (GFR), calculated by the Modification of Diet in Renal Disease (MDRD) method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per World Health Organization (WHO) criteria. Participants completed the study after Week 1; data contributed to prevalence estimates.
496438|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496439|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496440|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496441|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496566|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496442|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496443|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496444|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496445|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496446|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496447|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496448|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496449|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496450|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496451|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496452|NCT00727571|O2|Outcome|No CKD But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496453|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496454|NCT00727571|O1|Outcome|All Enrolled Participants|
496455|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496456|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496457|NCT00727571|E4|Reported Event|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
496458|NCT00727571|E3|Reported Event|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496459|NCT00727571|E2|Reported Event|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496460|NCT00727571|E1|Reported Event|No CKD or Anemia|CKD is based on estimated GFR, calculated by the MDRD method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
496461|NCT00727597|B3|Baseline|Total|Total of all reporting groups
496462|NCT00727597|B2|Baseline|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
496463|NCT00727597|B1|Baseline|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
496464|NCT00727597|P2|Participant Flow|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
496465|NCT00727597|P1|Participant Flow|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
496466|NCT00727597|O2|Outcome|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
496469|NCT00727597|O1|Outcome|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
496470|NCT00727597|E2|Reported Event|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
496471|NCT00727597|E1|Reported Event|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
496472|NCT00727636|B3|Baseline|Total|Total of all reporting groups
496473|NCT00727636|B2|Baseline|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
496474|NCT00727636|B1|Baseline|Prospective Cohort|Received Gardasil as part of study
496475|NCT00727636|P2|Participant Flow|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
496476|NCT00727636|P1|Participant Flow|Prospective Cohort|Received Gardasil as part of study
496477|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
496478|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
496479|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
496480|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
496567|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496481|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
496482|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
496483|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
496484|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
496485|NCT00727636|E2|Reported Event|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
496486|NCT00727636|E1|Reported Event|Prospective Cohort|Received Gardasil as part of study
496487|NCT00727649|B3|Baseline|Total|Total of all reporting groups
496488|NCT00727649|B2|Baseline|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg pill
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
496489|NCT00727649|B1|Baseline|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 2 mg placebo daily with weekly dose adjustments for side-effects and/or efficacy"
496490|NCT00727649|P2|Participant Flow|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
496491|NCT00727649|P1|Participant Flow|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
496492|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
496493|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
496494|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
496495|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
496496|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
496497|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
496498|NCT00727649|E4|Reported Event|L1P2 (Psyllium Second); 2nd 4-weeks|"Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
496499|NCT00727649|E3|Reported Event|P1L2 (Loperamide Second); 2nd 4-weeks|"Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
496500|NCT00727649|E2|Reported Event|L1P2 (Loperamide First): 1st 4-weeks|"Fiber (psyllium) powder placebo with loperamide 2mg
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
496550|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496501|NCT00727649|E1|Reported Event|P1L2 (Psyllium First); 1st 4-weeks|"Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
496502|NCT00727714|B1|Baseline|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
496503|NCT00727714|P1|Participant Flow|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
496504|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
496505|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
496506|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
496507|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
496508|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
496509|NCT00727714|E1|Reported Event|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
496510|NCT00727740|B3|Baseline|Total|Total of all reporting groups
496511|NCT00727740|B2|Baseline|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.
Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
496512|NCT00727740|B1|Baseline|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.
Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
496513|NCT00727740|P2|Participant Flow|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.
Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
496514|NCT00727740|P1|Participant Flow|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.
Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
496515|NCT00727740|O2|Outcome|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.
Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
496516|NCT00727740|O1|Outcome|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.
Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
496517|NCT00727740|E2|Reported Event|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.
Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
496551|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496552|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496553|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
498382|NCT00732160|O4|Outcome|Aldosterone, LS|Aldosterone Infusion, Low Salt diet
496518|NCT00727740|E1|Reported Event|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.
Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
496519|NCT00727844|B3|Baseline|Total|Total of all reporting groups
496520|NCT00727844|B2|Baseline|Delayed Start Linezolid|Subjects will continue their existing regimen for 2 months after which LZD (600 mg once daily) will be added. After 2 consecutive AFB negative sputum smears (not to exceed 4 months of LZD therapy), subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
496521|NCT00727844|B1|Baseline|Immediate Start Linezolid|Upon completion of entry criteria, subjects will have LZD (600 mg once daily) added to their regimen. After 2 consecutive AFB negative sputum smears (or at 4 months) subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
496568|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496522|NCT00727844|P4|Participant Flow|2nd Randomization: Linezolid 300 mg Daily|After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities.
496523|NCT00727844|P3|Participant Flow|2nd Randomization: Linezolid 600 mg Daily|After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities.
496524|NCT00727844|P2|Participant Flow|Initial Randomization: Delayed Start Linezolid|Subjects continued their existing treatment regimen for 2 additional months after which linezolid 600 mg once daily was added.
496525|NCT00727844|P1|Participant Flow|Initial Randomization: Immediate Start Linezolid|Upon completion of entry criteria, subjects immediately added linezolid 600 mg once daily to their ongoing TB treatment regimen.
496526|NCT00727844|O2|Outcome|Delayed Start Linezolid|Subjects will continue their existing regimen for 2 months after which LZD (600 mg once daily) will be added. After 2 consecutive AFB negative sputum smears (not to exceed 4 months of LZD therapy), subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
496527|NCT00727844|O1|Outcome|Immediate Start Linezolid|Upon completion of entry criteria, subjects will have LZD (600 mg once daily) added to their regimen. After 2 consecutive AFB negative sputum smears (or at 4 months) subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
496528|NCT00727844|E1|Reported Event|Clinically Significant AEs|All clinically significant adverse events, regardless of relationship to linezolid. This includes all SAEs, all AEs grade 3 and above, and all neuropathies grade 2 and above.
496529|NCT00727857|B4|Baseline|Total|Total of all reporting groups
496530|NCT00727857|B3|Baseline|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496531|NCT00727857|B2|Baseline|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496532|NCT00727857|B1|Baseline|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496533|NCT00727857|P3|Participant Flow|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496534|NCT00727857|P2|Participant Flow|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496535|NCT00727857|P1|Participant Flow|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496536|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496537|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496538|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg/Metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496539|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496540|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496541|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496542|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496543|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496544|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496545|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496546|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496547|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496548|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496549|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496555|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496556|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496557|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496558|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496559|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496560|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496561|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496562|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496563|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496564|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496565|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
498845|NCT00733096|E3|Reported Event|Saline|Two epidural saline injections
496569|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496570|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496571|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496572|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496573|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496574|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496575|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496576|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496577|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496578|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496579|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496580|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496581|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496582|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496583|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496584|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496585|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496586|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496587|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496588|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496589|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496590|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496591|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496592|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496593|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496594|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496595|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496596|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496597|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496598|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496599|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496600|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496601|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496602|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496603|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
498383|NCT00732160|O3|Outcome|Aldosterone, HS|Aldosterone Infusion, High Salt diet
496604|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496605|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496606|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496607|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496608|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496609|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496610|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496611|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496612|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496613|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496614|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496615|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496616|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496617|NCT00727857|E3|Reported Event|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
496618|NCT00727857|E2|Reported Event|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
496619|NCT00727857|E1|Reported Event|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
496620|NCT00727909|B1|Baseline|All Study Participants|All study participants received all three hearing aid treatments (TC, RITA, RITE). The sequence of treatments was counter-balanced to prevent an order effect. Each hearing aid treatment lasted two months. Each treatment period was followed by the administration of a series of outcome measures before the next treatment was begun. At the conclusion of the third treatment, in addition to administration of the outcome measures, the participants were asked to rank the three hearing aid treatments in order of preference, and to provide subjective comments regarding the rationale for their rank-ordering.
496621|NCT00727909|P4|Participant Flow|RITA RITE TC|Participants received the Receiver in the Aid (RITA) hearing aid first, followed by Receiver in the Ear (RITE), followed by Traditional Custom (TC). The length of each hearing aid treatment condition was 2 months.
496622|NCT00727909|P3|Participant Flow|RITE RITA TC|Participants received the Receiver in the Ear (RITE) hearing aid first, followed by Receiver in the Aid (RITA), followed by Traditional Custom hearing aid (TC). The length of each hearing aid treatment condition was 2 months.
496623|NCT00727909|P2|Participant Flow|TC RITA RITE|Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Aid (RITA), followed by Receiver in the Ear (RITE). The length of each hearing aid treatment condition was 2 months.
496624|NCT00727909|P1|Participant Flow|TC RITE RITA|Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Ear (RITE), followed by Receiver in the Aid (RITA). The length of each hearing aid treatment condition was 2 months.
496625|NCT00727909|O1|Outcome|All Participants|All participants received all three hearing aid treatments.
496626|NCT00727909|E1|Reported Event|All Study Participants|All participants received all three hearing aid treatments.
496627|NCT00727961|B1|Baseline|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
496628|NCT00727961|P1|Participant Flow|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
496629|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
496630|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
496631|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
496632|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
496633|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
496634|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
496635|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
496636|NCT00727961|E1|Reported Event|Caelyx Intravenous|
496637|NCT00728130|B1|Baseline|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
496638|NCT00728130|P1|Participant Flow|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
496639|NCT00728130|O1|Outcome|Surgical Lymph Node Groups|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.
496640|NCT00728130|O1|Outcome|Surgical Lymph Node Groups|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.
496641|NCT00728130|E1|Reported Event|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
496642|NCT00728182|B3|Baseline|Total|Total of all reporting groups
496643|NCT00728182|B2|Baseline|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496644|NCT00728182|B1|Baseline|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496645|NCT00728182|P2|Participant Flow|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496646|NCT00728182|P1|Participant Flow|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496647|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496648|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496649|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496650|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496651|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496652|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496653|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496654|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496655|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496656|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496657|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496658|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496659|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496660|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496661|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496662|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496663|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496664|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496665|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496666|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496667|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496668|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496669|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496670|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496671|NCT00728182|E2|Reported Event|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
496672|NCT00728182|E1|Reported Event|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.
NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
496673|NCT00728260|B1|Baseline|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice."
496696|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
497641|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
496674|NCT00728260|P1|Participant Flow|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice."
496675|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice."
496701|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496965|NCT00729326|E1|Reported Event|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496676|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice."
496677|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice."
496678|NCT00728260|E1|Reported Event|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.
Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.
Menactra vaccine was administered according to routine clinical practice."
496679|NCT00728416|B3|Baseline|Total|Total of all reporting groups
496680|NCT00728416|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
496681|NCT00728416|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
496682|NCT00728416|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
496683|NCT00728416|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
496684|NCT00728416|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
496685|NCT00728416|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
496686|NCT00728416|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
496687|NCT00728416|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
496688|NCT00728416|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
496689|NCT00728416|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
496690|NCT00728468|B1|Baseline|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496691|NCT00728468|P1|Participant Flow|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496692|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496693|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496694|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496695|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496720|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
496697|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496698|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496699|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496700|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496702|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496703|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496704|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496705|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496706|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496707|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496708|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496709|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496710|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496711|NCT00728468|E1|Reported Event|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
496712|NCT00728481|B3|Baseline|Total|Total of all reporting groups
496713|NCT00728481|B2|Baseline|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
496714|NCT00728481|B1|Baseline|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
496715|NCT00728481|P2|Participant Flow|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
496716|NCT00728481|P1|Participant Flow|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
496717|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
496718|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
496719|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
496721|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
496722|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
496723|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
496724|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
496725|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
496726|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
496727|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
496728|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
496729|NCT00728481|E2|Reported Event|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
496730|NCT00728481|E1|Reported Event|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
496731|NCT00728494|B3|Baseline|Total|Total of all reporting groups
496732|NCT00728494|B2|Baseline|Treatment Alone|PegIntron/Rebetol treatment only
496733|NCT00728494|B1|Baseline|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
496734|NCT00728494|P2|Participant Flow|Treatment Alone|PegIntron/Rebetol treatment only
496735|NCT00728494|P1|Participant Flow|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
496736|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
496737|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
496738|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
496739|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
496740|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
496741|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
496742|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
496743|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
496744|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
496745|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
496746|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
496747|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
496748|NCT00728494|E2|Reported Event|Treatment Alone|
496749|NCT00728494|E1|Reported Event|Treatment and Patient Assistance Program|
496750|NCT00728507|B3|Baseline|Total|Total of all reporting groups
496751|NCT00728507|B2|Baseline|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
496851|NCT00728962|E1|Reported Event|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
496752|NCT00728507|B1|Baseline|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
496753|NCT00728507|P2|Participant Flow|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
496754|NCT00728507|P1|Participant Flow|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
496755|NCT00728507|O2|Outcome|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
496784|NCT00728728|P1|Participant Flow|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
496756|NCT00728507|O1|Outcome|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
496757|NCT00728507|O2|Outcome|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
496758|NCT00728507|O1|Outcome|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
496759|NCT00728507|E2|Reported Event|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
496760|NCT00728507|E1|Reported Event|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
496761|NCT00728689|B3|Baseline|Total|Total of all reporting groups
496762|NCT00728689|B2|Baseline|ST-246 Form V Followed by Form I|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
496763|NCT00728689|B1|Baseline|ST-246 Form I Followed by Form V|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
496764|NCT00728689|P2|Participant Flow|ST-246 Form V Followed by Form I|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
496765|NCT00728689|P1|Participant Flow|ST-246 Form I Followed by Form V|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
496766|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496767|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496768|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496769|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496770|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496771|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496772|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496773|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496774|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496775|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496815|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496776|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period. Drug was administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
496777|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period. Drug was administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
496778|NCT00728689|E2|Reported Event|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496779|NCT00728689|E1|Reported Event|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
496780|NCT00728728|B3|Baseline|Total|Total of all reporting groups
496781|NCT00728728|B2|Baseline|Arm 2: Placebo|Placebo control group
496782|NCT00728728|B1|Baseline|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
496783|NCT00728728|P2|Participant Flow|Arm 2: Placebo|Placebo control group
496786|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
496787|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
496788|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
496789|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
496790|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
496791|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo: Placebo
496792|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
496793|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
496794|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
496795|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
496796|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
496797|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
496798|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
496799|NCT00728728|E2|Reported Event|Arm 2: Placebo|"Placebo
Placebo: Placebo"
496800|NCT00728728|E1|Reported Event|Arm 1: Pregnenolone|"Pregnenolone
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial."
496801|NCT00728754|B3|Baseline|Total|Total of all reporting groups
496802|NCT00728754|B2|Baseline|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
496803|NCT00728754|B1|Baseline|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
496804|NCT00728754|P2|Participant Flow|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
496805|NCT00728754|P1|Participant Flow|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
496806|NCT00728754|O2|Outcome|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
496807|NCT00728754|O1|Outcome|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
496808|NCT00728754|E2|Reported Event|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
496809|NCT00728754|E1|Reported Event|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
496810|NCT00728845|B3|Baseline|Total|Total of all reporting groups
496811|NCT00728845|B2|Baseline|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496812|NCT00728845|B1|Baseline|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496813|NCT00728845|P2|Participant Flow|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496814|NCT00728845|P1|Participant Flow|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496816|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496817|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496818|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496819|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496820|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496821|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496966|NCT00729365|B4|Baseline|Total|Total of all reporting groups
496822|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496823|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496824|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496825|NCT00728845|E2|Reported Event|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496826|NCT00728845|E1|Reported Event|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
496827|NCT00728884|B1|Baseline|Certain Prevail Implants|Osseotite surfaced implants with internal connection
496828|NCT00728884|P1|Participant Flow|Certain Prevail Implants|Osseotite surfaced implants with internal connection
496829|NCT00728884|O1|Outcome|Certain Prevail Implants|Osseotite surfaced implants with internal connection
496830|NCT00728884|E1|Reported Event|Certain Prevail Implants|Osseotite surfaced implants with internal connection
496831|NCT00728910|B1|Baseline|Group 1|All participants received atorvastatin 10 mg/day for 4 weeks, followed by sequential addition of ABT335 135 mg/day for 8 weeks, and ER niacin 2000 mg/day for 10 weeks.
496832|NCT00728910|P1|Participant Flow|Atorvastatin/ABT335/Niaspan|All participants received atorvastatin 10 mg/day for 4 weeks, followed by sequential addition of ABT335 135 mg/day for 8 weeks, and ER niacin 2000 mg/day for 10 weeks, for a total study duration of 22 weeks
496833|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks followed by an oral fat tolerance test.
496834|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks followed by an oral fat tolerance test.
496835|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by an oral fat tolerance test
496836|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks.
496837|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks.
496838|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by apo-A1 kinetics
496839|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks.
496840|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks.
496841|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by apo-A1 kinetics
496842|NCT00728910|E1|Reported Event|Atorvastatin/ABT335/Niaspan|Subjects received atorvastatin 10 mg/day for 4 weeks, followed by addition of ABT335 135 mg/day for a further 8 weeks followed by the addition of Niaspan 2000 mg/day for a further 10 weeks.
496843|NCT00728923|B1|Baseline|Minocycline|minocycline 100mg bid for 12 weeks
496844|NCT00728923|P1|Participant Flow|Minocycline|minocycline 100mg bid for 12 weeks
496845|NCT00728923|O1|Outcome|Minocycline|Subjects received minocycline at 50mg BID (twice daily) for 3 days and then at 100mg BID for 12 weeks in addition to their SRI (serotonin reuptake inhibitor).
496846|NCT00728923|O1|Outcome|Minocycline|Subjects received minocycline at 50mg BID (twice daily) for 3 days and then at 100mg BID for 12 weeks in addition to their SRI (serotonin reuptake inhibitor).
496847|NCT00728923|E1|Reported Event|Minocycline|minocycline 100mg bid for 12 weeks
496848|NCT00728962|B1|Baseline|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
496849|NCT00728962|P1|Participant Flow|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
496850|NCT00728962|O1|Outcome|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
496853|NCT00728988|B2|Baseline|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
496854|NCT00728988|B1|Baseline|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
496855|NCT00728988|P2|Participant Flow|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
496856|NCT00728988|P1|Participant Flow|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
496857|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
496858|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
497020|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
496859|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
496860|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre-PCI and 40 mg 2 hours pre-percutaneous coronary intervention (PCI), and usual care.
496861|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
496862|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre-PCI and 40 mg 2 hours pre-percutaneous coronary intervention (PCI), and usual care.
496863|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
496864|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
496865|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
496866|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
496867|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
496868|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
496869|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
496870|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
496871|NCT00728988|E2|Reported Event|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
496872|NCT00728988|E1|Reported Event|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
496873|NCT00729157|B1|Baseline|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
496874|NCT00729157|P1|Participant Flow|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
496891|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496892|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496875|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
496876|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
572690|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
496877|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
496878|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
496879|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
496880|NCT00729157|E1|Reported Event|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
496881|NCT00729183|B3|Baseline|Total|Total of all reporting groups
496882|NCT00729183|B2|Baseline|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496883|NCT00729183|B1|Baseline|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496884|NCT00729183|P2|Participant Flow|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496885|NCT00729183|P1|Participant Flow|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496886|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496887|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496888|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496889|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496890|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496893|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496894|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496895|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496896|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496897|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
497126|NCT00721253|B2|Baseline|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
496898|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496899|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496900|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496901|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496902|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496903|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496904|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496905|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496906|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496907|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496908|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496909|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496910|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496911|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496912|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496913|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496914|NCT00729183|E2|Reported Event|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496915|NCT00729183|E1|Reported Event|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
496916|NCT00729248|B1|Baseline|All Participants|"All participants (6 donors, 6 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination:
Recipient PMBC + Donor PBMC + No drug Recipient PMBC + Donor PBMC + Tacrolimus (TAC) Recipient PMBC + Donor PBMC + Sirolimus (SRL)"
496955|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496956|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496917|NCT00729248|P1|Participant Flow|Participants|12 participants were recruited/consented for the study. 2 subjects (donor/recipient pair) were withdrawn from the study. Ten participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
496918|NCT00729248|O2|Outcome|MLRs in the Presence of SRL|"All participants (5 donors, 5 recipietns) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in teh following combination:
Recipient PMBC + Donor PBMC + Sirolimus (SRL)"
496919|NCT00729248|O1|Outcome|MLRs in the Presence of TAC|"All participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination:
REcipient PMBC + Donor PBMC + Tacrolimus (TAC)"
496920|NCT00729248|E1|Reported Event|All Participants|All participants (6 donors, 6 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
496921|NCT00729326|B3|Baseline|Total|Total of all reporting groups
496922|NCT00729326|B2|Baseline|Sitagliptin Followed By Exenatide|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496923|NCT00729326|B1|Baseline|Exenatide Followed By Sitagliptin|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496924|NCT00729326|P2|Participant Flow|Sitagliptin Followed By Exenatide|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496925|NCT00729326|P1|Participant Flow|Exenatide Followed By Sitagliptin|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496926|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496927|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496928|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496929|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496930|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496931|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496932|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496933|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496934|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496935|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496936|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496937|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496938|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496939|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496940|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496941|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496942|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496943|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496944|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496945|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496946|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496947|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496948|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496949|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496950|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496951|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496952|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496953|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496954|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496957|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496958|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496959|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496960|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496961|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496962|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
496963|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
496964|NCT00729326|E2|Reported Event|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
498846|NCT00733096|E2|Reported Event|Etanercept|Two epidural etanercept injections
496967|NCT00729365|B3|Baseline|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).
Ramipril: ACE inhibitor known as Ramipril
Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
496968|NCT00729365|B2|Baseline|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.
Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
496969|NCT00729365|B1|Baseline|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.
Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
496970|NCT00729365|P3|Participant Flow|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).
Ramipril: ACE inhibitor known as Ramipril
Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
496971|NCT00729365|P2|Participant Flow|Non-dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.
Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
496972|NCT00729365|P1|Participant Flow|Dippers - Placebo Group|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.
Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
496973|NCT00729365|O3|Outcome|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).
Ramipril: ACE inhibitor known as Ramipril
Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
496974|NCT00729365|O2|Outcome|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.
Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
496975|NCT00729365|O1|Outcome|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.
Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
496976|NCT00729365|O3|Outcome|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).
Ramipril: ACE inhibitor known as Ramipril
Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
496977|NCT00729365|O2|Outcome|Non-dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.
Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
496978|NCT00729365|O1|Outcome|Dippers - Placebo Group|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.
Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
496979|NCT00729365|E3|Reported Event|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).
Ramipril: ACE inhibitor known as Ramipril
Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
496980|NCT00729365|E2|Reported Event|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.
Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
496981|NCT00729365|E1|Reported Event|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.
Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
496982|NCT00729430|B3|Baseline|Total|Total of all reporting groups
496983|NCT00729430|B2|Baseline|Placebo Arm|"Participants will receive placebo for 6 months.
Placebo: Placebo tablets taken orally once per day for 6 months"
496984|NCT00729430|B1|Baseline|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
496985|NCT00729430|P2|Participant Flow|Placebo Arm|"Participants will receive placebo for 6 months.
Placebo: Placebo tablets taken orally once per day for 6 months"
496986|NCT00729430|P1|Participant Flow|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
496987|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.
Placebo: Placebo tablets taken orally once per day for 6 months"
496988|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acids Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
496989|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.
Placebo: Placebo tablets taken orally once per day for 6 months"
497127|NCT00721253|B1|Baseline|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
496990|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acids Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
496991|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.
Placebo: Placebo tablets taken orally once per day for 6 months"
496992|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
496993|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.
Placebo: Placebo tablets taken orally once per day for 6 months"
496994|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
496995|NCT00729430|E2|Reported Event|Placebo Arm|"Participants will receive placebo for 6 months.
Placebo: Placebo tablets taken orally once per day for 6 months"
496996|NCT00729430|E1|Reported Event|High Dose Omega-3 Fatty Acids Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
496997|NCT00729469|B3|Baseline|Total|Total of all reporting groups
496998|NCT00729469|B2|Baseline|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
496999|NCT00729469|B1|Baseline|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497000|NCT00729469|P2|Participant Flow|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497001|NCT00729469|P1|Participant Flow|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497002|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497003|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497004|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497005|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497006|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497007|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497008|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497009|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497010|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497011|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497012|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497013|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497642|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
497014|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497015|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497016|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497017|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497018|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497019|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497021|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497022|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497023|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497024|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497025|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497026|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497027|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497028|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497029|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497030|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497031|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497032|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497033|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497034|NCT00729469|E2|Reported Event|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497035|NCT00729469|E1|Reported Event|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
497036|NCT00729482|B1|Baseline|RAD001|Treatment Arm (RAD001)
497037|NCT00729482|P1|Participant Flow|RAD001|Treatment Arm (RAD001)
497038|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
497039|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
497040|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
497041|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
497042|NCT00729482|E1|Reported Event|RAD001|Treatment Arm (RAD001)
497043|NCT00729521|B4|Baseline|Total|Total of all reporting groups
497044|NCT00729521|B3|Baseline|Facilitative System|"a Facilitative System group of five communities and their residents over 65 years of age receiving support in addition to the resources provided the Standard Program group
facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
497643|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
497045|NCT00729521|B2|Baseline|Standard Program|"a Standard Program group of five communities and their residents over 65 years of age receiving modest funding to implement an evidence-based fall prevention program in their local community;
Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
497046|NCT00729521|B1|Baseline|Control|a control group of 10 communities and their residents over 65 years of age receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
497047|NCT00729521|P3|Participant Flow|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group
facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
497069|NCT00729651|B1|Baseline|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks
497048|NCT00729521|P2|Participant Flow|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;
Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
497049|NCT00729521|P1|Participant Flow|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
497050|NCT00729521|O3|Outcome|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group
facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
497051|NCT00729521|O2|Outcome|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;
Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
497052|NCT00729521|O1|Outcome|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
497053|NCT00729521|E3|Reported Event|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group
facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
497054|NCT00729521|E2|Reported Event|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;
Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
497055|NCT00729521|E1|Reported Event|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
497056|NCT00729560|B1|Baseline|Flutamide Treated and Placebo Control|Flutamide treated: 250 mg twice daily for 4 weeks or Placebo control: twice daily for 4 weeks. Study was terminated due to insufficient enrollment. Randomization is unknown as study was terminated prior to unblinding and no key can be found. Consequently, we are unable to differentiate between treated and control subjects.
497057|NCT00729560|P1|Participant Flow|Flutamide and Placebo Control Subjects|Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
497058|NCT00729560|O1|Outcome|Flutamide and Placebo Control Subjects|Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
497059|NCT00729560|E1|Reported Event|Flutamide Treated and Placebo Control Subjects|Flutamide: 250 mg twice daily for 4 weeks or Placebo: twice daily for 4 weeks
497060|NCT00729612|B1|Baseline|Treatment (Nab-paclitaxel, Carboplatin)|"Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
carboplatin
paclitaxel albumin-stabilized nanoparticle formulation
protein expression analysis
immunoenzyme technique
immunohistochemistry staining method
laboratory biomarker analysis"
497061|NCT00729612|P1|Participant Flow|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
497062|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
497085|NCT00729677|O1|Outcome|Participants on 2-drug Regimen|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving 2-drug antiemetic regimens who reported nausea.
497063|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
497064|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
497065|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
497066|NCT00729612|E1|Reported Event|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
497067|NCT00729651|B3|Baseline|Total|Total of all reporting groups
497068|NCT00729651|B2|Baseline|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks
497070|NCT00729651|P2|Participant Flow|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks
497071|NCT00729651|P1|Participant Flow|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks
497072|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
497073|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
497074|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
497075|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
497076|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
497077|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
497078|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
497079|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
497080|NCT00729651|E2|Reported Event|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs
497081|NCT00729651|E1|Reported Event|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs
497082|NCT00729677|B1|Baseline|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
497083|NCT00729677|P1|Participant Flow|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
497084|NCT00729677|O2|Outcome|Participants on 3-drug Regimen|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving 2-drug antiemetic regimens who reported nausea.
497086|NCT00729677|O2|Outcome|Participants With No History of Nausea|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving regimens containing oxaliplatin who had no history of nausea.
497087|NCT00729677|O1|Outcome|Participants With History of Nausea|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving regimens containing oxaliplatin who had history of nausea.
497088|NCT00729677|O1|Outcome|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
497089|NCT00729677|O3|Outcome|Transgender|transgender subject starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
497090|NCT00729677|O2|Outcome|Males|males starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
497091|NCT00729677|O1|Outcome|Females|females starting chemotherapy for stage 3 or 4 colorectal cancer with regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
497092|NCT00729677|E1|Reported Event|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
497093|NCT00729690|B4|Baseline|Total|Total of all reporting groups
497094|NCT00729690|B3|Baseline|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
497095|NCT00729690|B2|Baseline|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
497096|NCT00729690|B1|Baseline|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
497097|NCT00729690|P3|Participant Flow|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
497098|NCT00729690|P2|Participant Flow|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
497099|NCT00729690|P1|Participant Flow|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
497100|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
497101|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
497102|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
497103|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
497104|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
497105|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
497106|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
497107|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
497108|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
497109|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
497110|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
497111|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
497112|NCT00729690|E3|Reported Event|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
497113|NCT00729690|E2|Reported Event|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
497114|NCT00729690|E1|Reported Event|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
497115|NCT00729781|B1|Baseline|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
497116|NCT00729781|P1|Participant Flow|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
498384|NCT00732160|O2|Outcome|Vehicle, LS|Vehicle Infusion, Low Salt diet
497117|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
497118|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
497119|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
497120|NCT00729781|E1|Reported Event|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
497121|NCT00729807|B1|Baseline|Treatment Arm|
497128|NCT00721253|P3|Participant Flow|Tecnis MF|Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
497129|NCT00721253|P2|Participant Flow|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
497130|NCT00721253|P1|Participant Flow|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
497131|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
497132|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
497133|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
497134|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
497135|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
497136|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
497137|NCT00721253|E2|Reported Event|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
497138|NCT00721253|E1|Reported Event|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
497139|NCT00721279|B3|Baseline|Total|Total of all reporting groups
497140|NCT00721279|B2|Baseline|Pre-treated Patients|Patients that had been treated for RLS at baseline
497141|NCT00721279|B1|Baseline|De-novo Patients|Patients that had not been treated for RLS at baseline
497142|NCT00721279|P2|Participant Flow|Pre-treated Patients|Patients that had been treated for RLS at baseline
497143|NCT00721279|P1|Participant Flow|De-novo Patients|Patients that had not been treated for RLS at baseline
497144|NCT00721279|O1|Outcome|Overall|All Patients
497145|NCT00721279|O1|Outcome|Overall|All Patients
497146|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
497147|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
497148|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
497149|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
497150|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
497151|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
497152|NCT00721279|E2|Reported Event|Pre-treated Patients|Patients that had been treated for RLS at baseline
497153|NCT00721279|E1|Reported Event|De-novo Patients|Patients that had not been treated for RLS at baseline
497154|NCT00721357|B3|Baseline|Total|Total of all reporting groups
497155|NCT00721357|B2|Baseline|Control|"those without condition
Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity
Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
497156|NCT00721357|B1|Baseline|Stroke|"those with condition
Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity
Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
497157|NCT00721357|P2|Participant Flow|Control|"those without condition
Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity
Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
497158|NCT00721357|P1|Participant Flow|Stroke|"those with condition
Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity
Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
497159|NCT00721357|O2|Outcome|Control|"those without condition
Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity
Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
497160|NCT00721357|O1|Outcome|Stroke|"those with condition
Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity
Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
497644|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
497161|NCT00721357|E2|Reported Event|Group 2|"those without condition
Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity
Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
497162|NCT00721357|E1|Reported Event|Group 1|"those with condition
Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity
Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
497163|NCT00721396|B5|Baseline|Total|Total of all reporting groups
497164|NCT00721396|B4|Baseline|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
497165|NCT00721396|B3|Baseline|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
497166|NCT00721396|B2|Baseline|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
497167|NCT00721396|B1|Baseline|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
497168|NCT00721396|P4|Participant Flow|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
497169|NCT00721396|P3|Participant Flow|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
497170|NCT00721396|P2|Participant Flow|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
497171|NCT00721396|P1|Participant Flow|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
497172|NCT00721396|O2|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
497173|NCT00721396|O1|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
497174|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
497175|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
497176|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
497177|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
497178|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
497179|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
497180|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
497181|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
497182|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
497183|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
497184|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
497185|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
497186|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
497187|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
497188|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
497189|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
497190|NCT00721396|O2|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
497191|NCT00721396|O1|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
497192|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
497193|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
497194|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
497195|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations.
497196|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age.
497197|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations.
497198|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
497199|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
497200|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
497201|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
497202|NCT00721396|E4|Reported Event|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
497203|NCT00721396|E3|Reported Event|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
497204|NCT00721396|E2|Reported Event|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
497205|NCT00721396|E1|Reported Event|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
497206|NCT00721409|B4|Baseline|Total|Total of all reporting groups
497207|NCT00721409|B3|Baseline|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497208|NCT00721409|B2|Baseline|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497209|NCT00721409|B1|Baseline|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497210|NCT00721409|P3|Participant Flow|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497211|NCT00721409|P2|Participant Flow|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497212|NCT00721409|P1|Participant Flow|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497213|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497214|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497215|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497216|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497217|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497218|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497219|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497220|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497221|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497222|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497223|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497224|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497225|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497226|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497645|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
497227|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497228|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497229|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497230|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497231|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497232|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497233|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497234|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497235|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497236|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497237|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497238|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497239|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497240|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497241|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497242|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497243|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497244|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497245|NCT00721409|O4|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497246|NCT00721409|O3|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497247|NCT00721409|O2|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497248|NCT00721409|O1|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497249|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497250|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497251|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497252|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497279|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497253|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497254|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497255|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497256|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497257|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497258|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497259|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497260|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497261|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497262|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497263|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497264|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497265|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497266|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497267|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497268|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497269|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497270|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497271|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497272|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497273|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497274|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497275|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497276|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497277|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497278|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497280|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497281|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497282|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497283|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497284|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497285|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497286|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497287|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497288|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497289|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497290|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497291|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497292|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497293|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497294|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497295|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497296|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497297|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497298|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
497299|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
497300|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
497301|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
497302|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
497303|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
497304|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497305|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
497306|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497307|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
497308|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
498385|NCT00732160|O1|Outcome|Vehicle, HS|Vehicle Infusion, High Salt diet
497309|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
497310|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497311|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
497312|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497313|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
497314|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497315|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
497316|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497317|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
572691|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
497318|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497319|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497320|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497321|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497322|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497323|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497324|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497325|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497326|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497327|NCT00721409|E7|Reported Event|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497328|NCT00721409|E6|Reported Event|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497329|NCT00721409|E5|Reported Event|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
497330|NCT00721409|E4|Reported Event|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497331|NCT00721409|E3|Reported Event|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
497332|NCT00721409|E2|Reported Event|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
497333|NCT00721409|E1|Reported Event|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
497334|NCT00721500|B1|Baseline|All Subjects|All subjects who enrolled and completed study.
498788|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
497335|NCT00721500|P4|Participant Flow|Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A|First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
497336|NCT00721500|P3|Participant Flow|Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A|First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
497337|NCT00721500|P2|Participant Flow|Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.
497338|NCT00721500|P1|Participant Flow|Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.
497339|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
497340|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
497341|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
497342|NCT00721500|O1|Outcome|Narafilcon A (Bilateral)|Narafilcon A contact lens worn in both eyes.
497343|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
497344|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
497345|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
497346|NCT00721500|O1|Outcome|Narafilcon A|Narafilcon A contact lens worn in both eyes.
497347|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
497348|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
497349|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
497351|NCT00721500|E4|Reported Event|Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A|First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
497352|NCT00721500|E3|Reported Event|Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A|First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
497353|NCT00721500|E2|Reported Event|Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.
497354|NCT00721500|E1|Reported Event|Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.
497355|NCT00721539|B1|Baseline|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.
da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.
Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
497356|NCT00721539|P1|Participant Flow|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.
da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.
Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
497357|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.
da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.
Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
497358|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.
da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.
Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
497359|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.
da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.
Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
497380|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497646|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
497360|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.
da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.
Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
497361|NCT00721539|E1|Reported Event|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.
da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.
Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
497362|NCT00721578|B1|Baseline|Entire Study Population|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
497363|NCT00721578|P2|Participant Flow|Other Antifungal Treatment|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.
497364|NCT00721578|P1|Participant Flow|Voriconazole Antifungal Treatment|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.
498847|NCT00733096|E1|Reported Event|Steroid|Two epidural steroid injections
497365|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
497366|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infection|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
497367|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
497368|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
497369|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
497370|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
497371|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
497372|NCT00721578|O1|Outcome|All Antifungal Therapies|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
497373|NCT00721578|O1|Outcome|All Antifungal Therapies|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
497374|NCT00721578|E1|Reported Event|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
497375|NCT00721617|B1|Baseline|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h.
497376|NCT00721617|P1|Participant Flow|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497377|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497378|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497379|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
498789|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
497381|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497382|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497383|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497384|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497385|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497386|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497387|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497388|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497653|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
497389|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497390|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497391|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497392|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497393|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497394|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497395|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497396|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497397|NCT00721617|O1|Outcome|Healthy Subjects|Subjects received either IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours) in a random order.
497398|NCT00721617|E1|Reported Event|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
497399|NCT00721630|B1|Baseline|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
497400|NCT00721630|P1|Participant Flow|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
497401|NCT00721630|O1|Outcome|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
497402|NCT00721630|O1|Outcome|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
498386|NCT00732160|E4|Reported Event|Aldosterone, LS|Aldosterone Infusion, Low Salt diet
497403|NCT00721630|E1|Reported Event|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
497404|NCT00721734|B6|Baseline|Total|Total of all reporting groups
497405|NCT00721734|B5|Baseline|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497406|NCT00721734|B4|Baseline|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497407|NCT00721734|B3|Baseline|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497654|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
497408|NCT00721734|B2|Baseline|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497409|NCT00721734|B1|Baseline|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497410|NCT00721734|P5|Participant Flow|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497411|NCT00721734|P4|Participant Flow|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497412|NCT00721734|P3|Participant Flow|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497413|NCT00721734|P2|Participant Flow|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497414|NCT00721734|P1|Participant Flow|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497415|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497416|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497417|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497418|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497419|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497420|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497421|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497422|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497655|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
497423|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497424|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497425|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497426|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497427|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497428|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497429|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497430|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497431|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497432|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497433|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497560|NCT00722020|O2|Outcome|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
497434|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497435|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497436|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497437|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497438|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497439|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497440|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497441|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497442|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497443|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497444|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497445|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497446|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497447|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497448|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497633|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
498790|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
497449|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497450|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497451|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497452|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497453|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497454|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497455|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497456|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497457|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497458|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497459|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497460|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497461|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497462|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497463|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497634|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
498791|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
497464|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497465|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497466|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497467|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497468|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497469|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497470|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497471|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497472|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497473|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497474|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497475|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497476|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497477|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497478|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497635|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
498792|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
497479|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497480|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497481|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497482|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497483|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497484|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497485|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497486|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497487|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497488|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497489|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497490|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497491|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497492|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497493|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497636|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
502553|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
497494|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497495|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497496|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497497|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497498|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497499|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497500|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497501|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497502|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497503|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497504|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497505|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497506|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497507|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497508|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497637|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
502679|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
497509|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497510|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497511|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497512|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497513|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497514|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497515|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497516|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497517|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497518|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497519|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497520|NCT00721734|E5|Reported Event|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497521|NCT00721734|E4|Reported Event|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497522|NCT00721734|E3|Reported Event|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497523|NCT00721734|E2|Reported Event|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497638|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
497524|NCT00721734|E1|Reported Event|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
497525|NCT00721955|B4|Baseline|Total|Total of all reporting groups
497526|NCT00721955|B3|Baseline|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
497527|NCT00721955|B2|Baseline|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
497528|NCT00721955|B1|Baseline|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
497529|NCT00721955|P3|Participant Flow|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
497530|NCT00721955|P2|Participant Flow|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
497531|NCT00721955|P1|Participant Flow|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
497656|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
497532|NCT00721955|O3|Outcome|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
497533|NCT00721955|O2|Outcome|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
497534|NCT00721955|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
497535|NCT00721955|O3|Outcome|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
497536|NCT00721955|O2|Outcome|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
497537|NCT00721955|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
497538|NCT00721955|O3|Outcome|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
497539|NCT00721955|O2|Outcome|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
497540|NCT00721955|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
497541|NCT00721955|E3|Reported Event|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
497542|NCT00721955|E2|Reported Event|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
497543|NCT00721955|E1|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
497544|NCT00721968|B3|Baseline|Total|Total of all reporting groups
497545|NCT00721968|B2|Baseline|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
497546|NCT00721968|B1|Baseline|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
497547|NCT00721968|P2|Participant Flow|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
497548|NCT00721968|P1|Participant Flow|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
497549|NCT00721968|O2|Outcome|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
497550|NCT00721968|O1|Outcome|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
497551|NCT00721968|O2|Outcome|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
497552|NCT00721968|O1|Outcome|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
497553|NCT00721968|E2|Reported Event|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
497554|NCT00721968|E1|Reported Event|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
497555|NCT00722020|B3|Baseline|Total|Total of all reporting groups
497556|NCT00722020|B2|Baseline|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
497557|NCT00722020|B1|Baseline|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
497558|NCT00722020|P2|Participant Flow|Standard Care|"Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
Regular nebulized bronchodilator treatment.: Sham Vest treatment."
497559|NCT00722020|P1|Participant Flow|HFCWO / VEST Group|"Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.
High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest."
497561|NCT00722020|O1|Outcome|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
497562|NCT00722020|O2|Outcome|Standard Care|"Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
Regular nebulized bronchodilator treatment.: Sham Vest treatment."
497563|NCT00722020|O1|Outcome|HFCWO / VEST Group|"Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.
High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest."
497564|NCT00722020|E2|Reported Event|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
497565|NCT00722020|E1|Reported Event|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
497657|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
497658|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
499213|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
497566|NCT00722072|B1|Baseline|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:
500 mg IM on Day 1
250 mg IM on Day 15
Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
497567|NCT00722072|P1|Participant Flow|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:
500 mg IM on Day 1
250 mg IM on Day 15
Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
497568|NCT00722072|O1|Outcome|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:
500 mg IM on Day 1
250 mg IM on Day 15
Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
497569|NCT00722072|E1|Reported Event|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:
500 mg IM on Day 1
250 mg IM on Day 15
Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
497570|NCT00722124|B4|Baseline|Total|Total of all reporting groups
497571|NCT00722124|B3|Baseline|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
497572|NCT00722124|B2|Baseline|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
497573|NCT00722124|B1|Baseline|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
497574|NCT00722124|P3|Participant Flow|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
497575|NCT00722124|P2|Participant Flow|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
497576|NCT00722124|P1|Participant Flow|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
497577|NCT00722124|O3|Outcome|Placebo|
497578|NCT00722124|O2|Outcome|SAMe 1600|
497579|NCT00722124|O1|Outcome|SAMe 800|
497580|NCT00722124|E3|Reported Event|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
497581|NCT00722124|E2|Reported Event|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
497582|NCT00722124|E1|Reported Event|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
497583|NCT00722137|B3|Baseline|Total|Total of all reporting groups
497584|NCT00722137|B2|Baseline|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497585|NCT00722137|B1|Baseline|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
497586|NCT00722137|P2|Participant Flow|R-CHOP|"Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2
Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles"
497639|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
497640|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
503688|NCT00746395|B3|Baseline|Total|Total of all reporting groups
497587|NCT00722137|P1|Participant Flow|VcR-CAP|"Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2
Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles
VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles
Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497588|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497659|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
497660|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
572692|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
497589|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
497590|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497591|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
497592|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497593|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
497594|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Oraly on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497595|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
497596|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Oraly on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497597|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
497598|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497599|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
497600|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497601|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
498387|NCT00732160|E3|Reported Event|Aldosterone, HS|Aldosterone Infusion, High Salt diet
497602|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497603|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
497661|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
497604|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497605|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
497606|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
VELCADE: intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497607|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
497608|NCT00722137|E2|Reported Event|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
497609|NCT00722137|E1|Reported Event|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
497610|NCT00722371|B8|Baseline|Total|Total of all reporting groups
497611|NCT00722371|B7|Baseline|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
497612|NCT00722371|B6|Baseline|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
497613|NCT00722371|B5|Baseline|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
497614|NCT00722371|B4|Baseline|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
497615|NCT00722371|B3|Baseline|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
497616|NCT00722371|B2|Baseline|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
497617|NCT00722371|B1|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
497618|NCT00722371|P7|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
497619|NCT00722371|P6|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
497620|NCT00722371|P5|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
497621|NCT00722371|P4|Participant Flow|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
497622|NCT00722371|P3|Participant Flow|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
497623|NCT00722371|P2|Participant Flow|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
497624|NCT00722371|P1|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
497625|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
497626|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
497627|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
497628|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
497629|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
497630|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
497631|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
497632|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
498388|NCT00732160|E2|Reported Event|Vehicle, LS|Vehicle Infusion, Low Salt diet
497647|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
497648|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
497649|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
497650|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
497651|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
497652|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
572693|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
497662|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
497663|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
497664|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
497665|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
497666|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
497667|NCT00722371|E7|Reported Event|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
497668|NCT00722371|E6|Reported Event|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
497669|NCT00722371|E5|Reported Event|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
497670|NCT00722371|E4|Reported Event|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
497671|NCT00722371|E3|Reported Event|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
497672|NCT00722371|E2|Reported Event|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
497673|NCT00722371|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
497674|NCT00722423|B3|Baseline|Total|Total of all reporting groups
497675|NCT00722423|B2|Baseline|Usucal Care Model|
497676|NCT00722423|B1|Baseline|Integrated Care Model|Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals.
497677|NCT00722423|P2|Participant Flow|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
497678|NCT00722423|P1|Participant Flow|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
497679|NCT00722423|O2|Outcome|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
497680|NCT00722423|O1|Outcome|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
497681|NCT00722423|O2|Outcome|Usual Care Model|"usual care
Patients receive care as usual in their HCV clinic. This care does not include the co-located mental health provider."
497712|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
497713|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
497682|NCT00722423|O1|Outcome|Integrated Care Model|"integrated care
Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals."
497683|NCT00722423|E2|Reported Event|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
497684|NCT00722423|E1|Reported Event|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
497685|NCT00722436|B3|Baseline|Total|Total of all reporting groups
497686|NCT00722436|B2|Baseline|Placebo|"Saline
saline: Placebo"
497687|NCT00722436|B1|Baseline|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group."
497688|NCT00722436|P2|Participant Flow|Placebo|"Saline
saline: Placebo"
572694|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
497689|NCT00722436|P1|Participant Flow|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group."
497690|NCT00722436|O2|Outcome|Placebo|"Saline
saline: Placebo"
497691|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group."
497692|NCT00722436|O2|Outcome|Placebo|"Saline
saline: Placebo"
497693|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group."
497694|NCT00722436|O2|Outcome|Placebo|"Saline
saline: Placebo"
497695|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group."
497696|NCT00722436|O2|Outcome|Placebo|"Saline
saline: Placebo"
497697|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group."
497698|NCT00722436|E2|Reported Event|Placebo|"Saline
saline: Placebo"
497699|NCT00722436|E1|Reported Event|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group."
497700|NCT00729833|B1|Baseline|Figitumumab + Sunitinib (All Combined)|All participants who received at least one dose of figitumumab plus sunitinib.
497701|NCT00729833|P4|Participant Flow|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of continuous daily dosing followed by 1 week off, until disease progression or unacceptable toxicity.
497702|NCT00729833|P3|Participant Flow|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
497703|NCT00729833|P2|Participant Flow|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
497704|NCT00729833|P1|Participant Flow|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab (CP-751,871) 10 milligram/kilogram (mg/kg) intravenous (IV) on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participant experienced a dose-limiting toxicity (DLT).
497705|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
497706|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497707|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497708|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
497709|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
497710|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497711|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497714|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
497715|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
497716|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
497717|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
497718|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
497719|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
497720|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
497780|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497721|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
497722|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
497723|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497724|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497725|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
497726|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
497727|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497728|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497729|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
497730|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
497731|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497732|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497733|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
497734|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
497735|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497736|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497737|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
497738|NCT00729833|E4|Reported Event|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
497739|NCT00729833|E3|Reported Event|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497740|NCT00729833|E2|Reported Event|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
497741|NCT00729833|E1|Reported Event|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
497742|NCT00729846|B3|Baseline|Total|Total of all reporting groups
497743|NCT00729846|B2|Baseline|Standard Fluence|"Standard Fluence
Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
497744|NCT00729846|B1|Baseline|Reduced Fluence|"Reduced Fluence
Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
497745|NCT00729846|P2|Participant Flow|Standard Fluence|"Standard Fluence
Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
497746|NCT00729846|P1|Participant Flow|Reduced Fluence|"Reduced Fluence
Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
499214|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
497747|NCT00729846|O2|Outcome|Standard Fluence|"Standard Fluence
Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
497748|NCT00729846|O1|Outcome|Reduced Fluence|"Reduced Fluence
Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
497749|NCT00729846|E2|Reported Event|Standard Fluence|"Standard Fluence
Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
497750|NCT00729846|E1|Reported Event|Reduced Fluence|"Reduced Fluence
Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
497751|NCT00729859|B4|Baseline|Total|Total of all reporting groups
497752|NCT00729859|B3|Baseline|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
497753|NCT00729859|B2|Baseline|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
497754|NCT00729859|B1|Baseline|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
497755|NCT00729859|P3|Participant Flow|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
497756|NCT00729859|P2|Participant Flow|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
497757|NCT00729859|P1|Participant Flow|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
497758|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
497759|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497760|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497761|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
497762|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497763|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497764|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
497765|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497766|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497767|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
497768|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497769|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497770|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole Pill|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
498389|NCT00732160|E1|Reported Event|Vehicle, HS|Vehicle Infusion, High Salt diet
497771|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497772|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497773|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole Pill|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
497774|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497775|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497776|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
497777|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497778|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497779|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole|Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
498005|NCT00730015|B2|Baseline|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
497781|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497782|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrazole pill 1 mg for 28 days
497783|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497784|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497785|NCT00729859|O3|Outcome|Group 3: Acyline + T-gel + Oral Anastrozole 1mg|Acyline SQ inj. Day 0 & 14 + T-gel and anastrozole for 28 days
497786|NCT00729859|O2|Outcome|Group 2: Acyline + T-gel 10g/Day + Placebo Pill|Acyline SQ inj. Day 0 & 14 + T-gel and placebo pill for 28 days
497787|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel + Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
497788|NCT00729859|E3|Reported Event|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
497789|NCT00729859|E2|Reported Event|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
497790|NCT00729859|E1|Reported Event|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
497791|NCT00729924|B1|Baseline|Raltegravir: 400mg Orally Every 12 Hours for 7 Days|Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
497792|NCT00729924|P1|Participant Flow|Raltegravir 400mg Orally Every 12 Hours for 7 Days.|Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
497793|NCT00729924|O2|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 T/T|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
497794|NCT00729924|O1|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 C/C|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.
497795|NCT00729924|O2|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 T/T|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
497796|NCT00729924|O1|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 C/C|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.
497797|NCT00729924|E1|Reported Event|Raltegravir: 400mg Orally Every 12 Hours for 7 Days|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.
497798|NCT00729937|B7|Baseline|Total|Total of all reporting groups
497799|NCT00729937|B6|Baseline|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497800|NCT00729937|B5|Baseline|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497801|NCT00729937|B4|Baseline|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497802|NCT00729937|B3|Baseline|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497803|NCT00729937|B2|Baseline|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497804|NCT00729937|B1|Baseline|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497805|NCT00729937|P6|Participant Flow|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497806|NCT00729937|P5|Participant Flow|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497807|NCT00729937|P4|Participant Flow|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497808|NCT00729937|P3|Participant Flow|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497809|NCT00729937|P2|Participant Flow|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497810|NCT00729937|P1|Participant Flow|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497811|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497812|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497813|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497814|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497815|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497816|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497817|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497818|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497819|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497820|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497821|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497822|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497823|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497824|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497825|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497826|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497827|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497828|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497829|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497830|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497831|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497832|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497833|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497834|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497835|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497836|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497837|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497901|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497838|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497839|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497840|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497841|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497842|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497843|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497844|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497845|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497846|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497847|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497848|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497849|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497850|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497851|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497852|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497853|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497854|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497855|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497856|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497857|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497858|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497859|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497860|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497861|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497862|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497863|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497864|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497865|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497866|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497867|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497868|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
498103|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
497869|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497870|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497871|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497872|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497873|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497874|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497875|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497876|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
499215|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
497877|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497878|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497879|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497880|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497881|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497882|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497883|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497884|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497885|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497886|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497887|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497888|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497889|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497890|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497891|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497892|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497893|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497894|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497895|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497896|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497897|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497898|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497899|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497900|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
498390|NCT00732199|B3|Baseline|Total|Total of all reporting groups
497902|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497903|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497904|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497905|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497906|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497907|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497908|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
572695|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
497909|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497910|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497911|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497912|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497913|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497914|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497915|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497916|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497917|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497918|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497919|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497920|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497921|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497922|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497923|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497924|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497925|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497926|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497927|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497928|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497929|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497930|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497931|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497932|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
498104|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
497933|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497934|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497935|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497936|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497937|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497938|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497939|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
572696|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
497940|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497941|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497942|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497943|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497944|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497945|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497946|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497947|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497948|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497949|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497950|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497951|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497952|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497953|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497954|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497955|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497956|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497957|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497958|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497959|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497960|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497961|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497962|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497963|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497995|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497964|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497965|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497966|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497967|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497968|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497969|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
498002|NCT00729937|E1|Reported Event|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
498003|NCT00730015|B4|Baseline|Total|Total of all reporting groups
497970|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497971|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497972|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497973|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497974|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497975|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497976|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497977|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497978|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497979|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497980|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497981|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497982|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497983|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497984|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497985|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497986|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497987|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497988|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497989|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497990|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497991|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497992|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497993|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
497994|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
497996|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
497997|NCT00729937|E6|Reported Event|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
497998|NCT00729937|E5|Reported Event|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
497999|NCT00729937|E4|Reported Event|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
498000|NCT00729937|E3|Reported Event|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
498001|NCT00729937|E2|Reported Event|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
498004|NCT00730015|B3|Baseline|Placebo|Dose matched placebo, oral administration, once per day
498006|NCT00730015|B1|Baseline|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
498007|NCT00730015|P3|Participant Flow|Placebo|Dose matched placebo, oral administration, once per day
498008|NCT00730015|P2|Participant Flow|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
498009|NCT00730015|P1|Participant Flow|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
498010|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
498011|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
498012|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
498013|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
498014|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
498015|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
498016|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
498017|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
498018|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
498019|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
498020|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
498021|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
498022|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
498023|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
498024|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
498025|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
498026|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
498027|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
498028|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
498029|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
498030|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
498031|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
498032|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
498033|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
498034|NCT00730015|E8|Reported Event|Linaclotide 290μg to Linaclotide 290μg RW Period|Linaclotide 290μg, oral administration, once per day to Linaclotide 290μg, oral administration, once per day
498035|NCT00730015|E7|Reported Event|Linaclotide 290μg to Placebo RW Period|Linaclotide 290μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
498036|NCT00730015|E6|Reported Event|Linaclotide 145μg to Linaclotide 145μg RW Period|Linaclotide 145μg, oral administration, once per day to Linaclotide 145μg, oral administration, once per day
498037|NCT00730015|E5|Reported Event|Linaclotide 145μg to Placebo RW Period|Linaclotide 145μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
498038|NCT00730015|E4|Reported Event|Placebo to Linaclotide 290μg Randomized Withdrawal (RW) Period|Dose-matched placebo, oral administration, once per day or Linaclotide 290μg, oral administration, once per day.
498039|NCT00730015|E3|Reported Event|Placebo|Dose matched placebo, oral administration, once per day
498040|NCT00730015|E2|Reported Event|Linaclotide 290μg|Linaclotide, 290μg dose, oral administration, once per day
498041|NCT00730015|E1|Reported Event|Linaclotide 145μg|Linaclotide, 145μg dose, oral administration, once per day
498042|NCT00730028|B6|Baseline|Total|Total of all reporting groups
498043|NCT00730028|B5|Baseline|Limited Abscess – Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
498099|NCT00730041|B2|Baseline|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
498100|NCT00730041|B1|Baseline|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
498044|NCT00730028|B4|Baseline|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498045|NCT00730028|B3|Baseline|Limited Abscess – Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498046|NCT00730028|B2|Baseline|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498047|NCT00730028|B1|Baseline|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498048|NCT00730028|P5|Participant Flow|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
498049|NCT00730028|P4|Participant Flow|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498050|NCT00730028|P3|Participant Flow|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498051|NCT00730028|P2|Participant Flow|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498052|NCT00730028|P1|Participant Flow|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498053|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
498054|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498055|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498056|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498057|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498058|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
498059|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498060|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498101|NCT00730041|P2|Participant Flow|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
498102|NCT00730041|P1|Participant Flow|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
498061|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498062|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498063|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
498064|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
499216|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
498065|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498066|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498067|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498068|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
498069|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498070|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498071|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498072|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498073|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
498074|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498075|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498076|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498077|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498078|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
498079|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498080|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498081|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498113|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
498114|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
498082|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498083|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
498084|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498085|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498086|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498087|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498088|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
498089|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498090|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498091|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498092|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498093|NCT00730028|E5|Reported Event|Limited Abscess – Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with placebo three times daily.
498094|NCT00730028|E4|Reported Event|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498095|NCT00730028|E3|Reported Event|Limited Abscess – Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498096|NCT00730028|E2|Reported Event|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
498097|NCT00730028|E1|Reported Event|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
498098|NCT00730041|B3|Baseline|Total|Total of all reporting groups
503818|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
498105|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
498106|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
498107|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
498108|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
498109|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
498110|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
498111|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
498112|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
498115|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
498116|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
498117|NCT00730041|E2|Reported Event|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
498118|NCT00730041|E1|Reported Event|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
498119|NCT00730132|B1|Baseline|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
498120|NCT00730132|P1|Participant Flow|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
498121|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
498122|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
498123|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
498124|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
498125|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
498126|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
498127|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
498128|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
498129|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
498130|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
498131|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
498158|NCT00731640|E1|Reported Event|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
498828|NCT00733096|B2|Baseline|Etanercept|Two epidural etanercept injections
498132|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
498133|NCT00730132|O1|Outcome|All Participants Analyzed|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C. A participant was included in the study in case the lipid lowering therapy was modified in one of the following options: 1- statin dose (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) titration, 2- administration of a new statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin), 3- administration of ezetimibe in addition to current statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) therapy.
498134|NCT00730132|E1|Reported Event|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
498135|NCT00731614|B3|Baseline|Total|Total of all reporting groups
498136|NCT00731614|B2|Baseline|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
498137|NCT00731614|B1|Baseline|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.
Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
498138|NCT00731614|P2|Participant Flow|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
498139|NCT00731614|P1|Participant Flow|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.
Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
498140|NCT00731614|O2|Outcome|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
498141|NCT00731614|O1|Outcome|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.
Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
498142|NCT00731614|E2|Reported Event|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
498143|NCT00731614|E1|Reported Event|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.
Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
498144|NCT00731640|B3|Baseline|Total|Total of all reporting groups
498145|NCT00731640|B2|Baseline|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
498146|NCT00731640|B1|Baseline|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
498147|NCT00731640|P2|Participant Flow|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
498148|NCT00731640|P1|Participant Flow|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
498149|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
498150|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
498151|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
498152|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
498153|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
498154|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
498155|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
498156|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
498157|NCT00731640|E2|Reported Event|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
498159|NCT00731653|B1|Baseline|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
498160|NCT00731653|P1|Participant Flow|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
498161|NCT00731653|O1|Outcome|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
498162|NCT00731653|E1|Reported Event|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
498163|NCT00731666|B1|Baseline|Titan® IPP|Subjects implanted with Titan® IPP
498164|NCT00731666|P1|Participant Flow|Titan® IPP|Subjects implanted with Titan® IPP
498165|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
498166|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
498167|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
498168|NCT00731666|E1|Reported Event|Titan® IPP|Subjects implanted with Titan® IPP
498169|NCT00731679|B3|Baseline|Total|Total of all reporting groups
498170|NCT00731679|B2|Baseline|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
499217|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
498171|NCT00731679|B1|Baseline|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
498172|NCT00731679|P2|Participant Flow|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
498173|NCT00731679|P1|Participant Flow|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
498174|NCT00731679|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
498175|NCT00731679|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
498176|NCT00731679|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
498177|NCT00731679|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
498178|NCT00731679|E2|Reported Event|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
498179|NCT00731679|E1|Reported Event|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
498180|NCT00731692|B4|Baseline|Total|Total of all reporting groups
498181|NCT00731692|B3|Baseline|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498182|NCT00731692|B2|Baseline|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498183|NCT00731692|B1|Baseline|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
498184|NCT00731692|P3|Participant Flow|Placebo to -FTY 0.5 mg|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498185|NCT00731692|P2|Participant Flow|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498186|NCT00731692|P1|Participant Flow|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
498187|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498188|NCT00731692|O1|Outcome|FTY720 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498189|NCT00731692|O3|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498190|NCT00731692|O2|Outcome|FTY720 1.25mg to 0.5 mg|fingolimod 1.25mg/0.5 mg group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg
498191|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
498192|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498193|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498194|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
498195|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498196|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498197|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
498198|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498199|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498200|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
498201|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498424|NCT00732212|O3|Outcome|Standard Variceal Group|Rate of standard visually guided hemostasis variceal patients who had complications within 30 days.
498202|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498203|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
498204|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498205|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498206|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
498207|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498208|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498209|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
499218|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
498210|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498211|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498212|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498213|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498214|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498215|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498216|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498217|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498218|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498219|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498220|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498221|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
498222|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
498223|NCT00731692|E6|Reported Event|Extension: Placebo-FTY0.5|Patients who received Placebo in core and received 0.5 mg of FTY during Extension
498224|NCT00731692|E5|Reported Event|Extension: FTY0.5-0.5|Patients who received FTY20 0.5 mg in core and received 0.5 mg of FTY during Extension
498225|NCT00731692|E4|Reported Event|Extension: FTY1.25-0.5|Patients who received FTY20 1.25 mg in core and received 0.5 mg of FTY during Extension
498226|NCT00731692|E3|Reported Event|Core: Placebo|Patients who received Placebo during core
498227|NCT00731692|E2|Reported Event|Core: FTY720 0.5 mg|Patients who received FTY720 0.5 mg during core
498228|NCT00731692|E1|Reported Event|Core: FTY720 1.25 mg|Patients who received FTY720 1.25 mg during core
498229|NCT00731731|B4|Baseline|Total|Total of all reporting groups
498230|NCT00731731|B3|Baseline|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498231|NCT00731731|B2|Baseline|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498232|NCT00731731|B1|Baseline|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498243|NCT00731731|O1|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498233|NCT00731731|P3|Participant Flow|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498284|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
498285|NCT00731822|E2|Reported Event|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
498286|NCT00731822|E1|Reported Event|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
498287|NCT00731874|B3|Baseline|Total|Total of all reporting groups
498234|NCT00731731|P2|Participant Flow|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498235|NCT00731731|P1|Participant Flow|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498236|NCT00731731|O3|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy
>
> temozolomide: Given PO
>
> vorinostat: Given PO
>
> cognitive assessment: Ancillary studies
>
> laboratory biomarker analysis: Correlative studies"
498237|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy
>
> temozolomide: Given PO
>
> vorinostat: Given PO
>
> cognitive assessment: Ancillary studies
>
> laboratory biomarker analysis: Correlative studies"
498238|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy
>
> temozolomide: Given PO
>
> vorinostat: Given PO
>
> cognitive assessment: Ancillary studies
>
> laboratory biomarker analysis: Correlative studies"
498239|NCT00731731|O1|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy
>
> temozolomide: Given PO
>
> vorinostat: Given PO
>
> cognitive assessment: Ancillary studies
>
> laboratory biomarker analysis: Correlative studies"
498240|NCT00731731|O3|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498241|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498242|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498829|NCT00733096|B1|Baseline|Steroid|Two epidural steroid injections
498244|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498396|NCT00732199|O1|Outcome|Healthy Young Adults|Young adults
498245|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
498246|NCT00731731|E3|Reported Event|Phase II|laboratory biomarker analysis: Correlative studies
498247|NCT00731731|E2|Reported Event|Phase I, Dose Level 1|laboratory biomarker analysis: Correlative studies
498248|NCT00731731|E1|Reported Event|Phase I, Dose Level 0|laboratory biomarker analysis: Correlative studies
498249|NCT00731783|B3|Baseline|Total|Total of all reporting groups
498250|NCT00731783|B2|Baseline|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
498251|NCT00731783|B1|Baseline|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
498252|NCT00731783|P2|Participant Flow|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days.
498253|NCT00731783|P1|Participant Flow|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days.
498254|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
498255|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
498256|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
498257|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
498258|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
498259|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
498260|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
498261|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
498262|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
498263|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
498264|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
498265|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
498266|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
498267|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
498268|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
498269|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
498270|NCT00731783|E2|Reported Event|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
498271|NCT00731783|E1|Reported Event|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
498272|NCT00731822|B3|Baseline|Total|Total of all reporting groups
498273|NCT00731822|B2|Baseline|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
498274|NCT00731822|B1|Baseline|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
498275|NCT00731822|P2|Participant Flow|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
498276|NCT00731822|P1|Participant Flow|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
498277|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
498278|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
498279|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
498280|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
503819|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
498281|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
498282|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
498283|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
498397|NCT00732199|O2|Outcome|Healthy Older Adults|Older adults
498288|NCT00731874|B2|Baseline|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL
Tacrolimus: Dosed to achieve target trough concentrations."
498289|NCT00731874|B1|Baseline|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL
Tacrolimus: Dosed to achieve target trough concentrations."
498290|NCT00731874|P2|Participant Flow|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL
Tacrolimus: Dosed to achieve target trough concentrations."
498291|NCT00731874|P1|Participant Flow|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL
Tacrolimus: Dosed to achieve target trough concentrations."
498292|NCT00731874|O2|Outcome|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL
Tacrolimus: Dosed to achieve target trough concentrations."
498293|NCT00731874|O1|Outcome|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL
Tacrolimus: Dosed to achieve target trough concentrations."
498294|NCT00731874|O2|Outcome|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL
Tacrolimus: Dosed to achieve target trough concentrations."
498295|NCT00731874|O1|Outcome|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL
Tacrolimus: Dosed to achieve target trough concentrations."
498296|NCT00731874|E2|Reported Event|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL
Tacrolimus: Dosed to achieve target trough concentrations."
498297|NCT00731874|E1|Reported Event|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL
Tacrolimus: Dosed to achieve target trough concentrations."
498298|NCT00731939|B1|Baseline|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498299|NCT00731939|P1|Participant Flow|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498300|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498301|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498302|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498303|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498304|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498305|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498306|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498307|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498308|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498309|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498310|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498311|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498377|NCT00732160|P1|Participant Flow|HS-V/A; LS-V/A|High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone
498378|NCT00732160|O4|Outcome|Aldosterone, LS|Aldosterone Infusion, Low Salt diet
498312|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498313|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498314|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498315|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498316|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498317|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498318|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498319|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498320|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498321|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498322|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498323|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498324|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498325|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498326|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498327|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498328|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498329|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498330|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498331|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498332|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498333|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498334|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498335|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498336|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498379|NCT00732160|O3|Outcome|Aldosterone, HS|Aldosterone Infusion, High Salt diet
498380|NCT00732160|O2|Outcome|Vehicle, LS|Vehicle Infusion, Low Salt diet
498337|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498338|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498339|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498340|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498341|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498342|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498343|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498344|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498345|NCT00731939|E1|Reported Event|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
498346|NCT00732030|B1|Baseline|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
498347|NCT00732030|P1|Participant Flow|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
498348|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
498349|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
498350|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
498351|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
498352|NCT00732030|E1|Reported Event|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
498353|NCT00732069|B1|Baseline|All Study Participants|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
498354|NCT00732069|P6|Participant Flow|Valsartan, Ramipril, Then Placebo|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
498355|NCT00732069|P5|Participant Flow|Ramipril, Valsartan, Then Placebo|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
498356|NCT00732069|P4|Participant Flow|Valsartan, Then Placebo, Then Ramipril|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
498357|NCT00732069|P3|Participant Flow|Ramipril, Then Placebo, Then Valsartan|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
498358|NCT00732069|P2|Participant Flow|Placebo, Valsartan, Then Ramipril|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
498359|NCT00732069|P1|Participant Flow|Placebo, Then Ramipril, Then Valsartan|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
498360|NCT00732069|O3|Outcome|Placebo|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
498361|NCT00732069|O2|Outcome|Valsartan|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
498362|NCT00732069|O1|Outcome|Ramipril|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
498363|NCT00732069|O3|Outcome|Placebo|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
498364|NCT00732069|O2|Outcome|Valsartan|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
498365|NCT00732069|O1|Outcome|Ramipril|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
498366|NCT00732069|E3|Reported Event|Placebo|All subjects receiving placebo
498367|NCT00732069|E2|Reported Event|Valsartan|All subjects receiving valsartan
498368|NCT00732069|E1|Reported Event|Ramipril|All subjects receiving ramipril
498369|NCT00732160|B5|Baseline|Total|Total of all reporting groups
498370|NCT00732160|B4|Baseline|LS-A/V; HS-A/V|Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle
498371|NCT00732160|B3|Baseline|LS-V/A; HS-V/A|Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone
498372|NCT00732160|B2|Baseline|HS-A/V; LS-A/V|High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle
498373|NCT00732160|B1|Baseline|HS-V/A; LS-V/A|High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone
498374|NCT00732160|P4|Participant Flow|LS-A/V; HS-A/V|Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle
498375|NCT00732160|P3|Participant Flow|LS-V/A; HS-V/A|Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone
498376|NCT00732160|P2|Participant Flow|HS-A/V; LS-A/V|High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle
503820|NCT00746733|O2|Outcome|Adderall XR|
498391|NCT00732199|B2|Baseline|Healthy Older Adults|"Healthy Older adults, age >55-60yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
498392|NCT00732199|B1|Baseline|Health Young Adults|"Health Young adults, age 18-50 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
498393|NCT00732199|P2|Participant Flow|Arm 2|"Older adults, age >/=60 yrs
hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation"
498394|NCT00732199|P1|Participant Flow|Arm 1|"Young adults, age 18-59yrs
hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation"
498395|NCT00732199|O2|Outcome|Healthy Older Adults|Older adults
498400|NCT00732199|O2|Outcome|Healthy Old Adults|"Older adults, age >60 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
498401|NCT00732199|O1|Outcome|Healthy Young Adults|"Young adults, age 18-50 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
498402|NCT00732199|E2|Reported Event|Healthy Older Adults|"Older adults, age >55-60 years
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
498403|NCT00732199|E1|Reported Event|Healthy Young Adults|"Young adults, age 18-50 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
498404|NCT00732212|B5|Baseline|Total|Total of all reporting groups
498405|NCT00732212|B4|Baseline|Doppler Variceal Group|Doppler variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
498406|NCT00732212|B3|Baseline|Standard Variceal Group|Standard variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
498407|NCT00732212|B2|Baseline|Doppler Non-variceal Group|Doppler non-variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
498408|NCT00732212|B1|Baseline|Standard Non-variceal Group|Standard non-variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
498409|NCT00732212|P2|Participant Flow|Standard Endoscopic Hemostasis|"Standard, visually guided endoscopic hemostasis based on visual cues of stigmata of hemorrhage and endoscopic control of bleeding or treatment of the stigmata according to current guidelines
Standard endoscopic hemostasis: Per current treatment guidelines for non-variceal UGI lesions - based upon stigmata of hemorrhage & visual cues for risk stratification and completion of endoscopic treatment."
498410|NCT00732212|P1|Participant Flow|Doppler Endoscopic Probe Assisted Hemostasis|"In addition to stigmata of hemorrhage and visual cues, Doppler endoscopic probe will be used for detection of blood flow before and after standard endoscopic hemostasis. If residual blood flow in the lesion is found after standard treatment, further endoscopic treatment will be applied as deemed safe by the investigator-endoscopist.
Doppler endoscopic ultrasound probe is used for blood flow detection"
498411|NCT00732212|O4|Outcome|Doppler Variceal Group|Length of hospitalization days in Doppler assisted variceal patients.
498412|NCT00732212|O3|Outcome|Standard Variceal Group|Length of hospitalization days in standard visually guided hemostasis variceal patients.
498413|NCT00732212|O2|Outcome|Doppler Non-variceal Group|Length of hospitalization days in Doppler assisted non-variceal patients.
498414|NCT00732212|O1|Outcome|Standard Non-variceal Group|Length of hospitalization days in standard visually guided hemostasis non-variceal patients.
498415|NCT00732212|O4|Outcome|Doppler Variceal Group|RBC units of transfusion post-randomization in Doppler assisted variceal patients.
498416|NCT00732212|O3|Outcome|Standard Variceal Group|RBC units of transfusion post-randomization in standard visually guided hemostasis variceal patients.
498417|NCT00732212|O2|Outcome|Doppler Non-variceal Group|RBC units of transfusion post-randomization in Doppler assisted non-variceal patients.
498418|NCT00732212|O1|Outcome|Standard Non-variceal Group|RBC units of transfusion post-randomization in standard visually guided hemostasis non-variceal patients.
498419|NCT00732212|O4|Outcome|Doppler Variceal Group|Number of deaths in Doppler assisted variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
498420|NCT00732212|O3|Outcome|Standard Variceal Group|Number of deaths in standard visually guided hemostasis variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
498421|NCT00732212|O2|Outcome|Doppler Non-variceal Group|Number of deaths in Doppler assisted non-variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
498422|NCT00732212|O1|Outcome|Standard Non-variceal Group|Number of deaths in standard visually guided hemostasis non-variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
498423|NCT00732212|O4|Outcome|Doppler Variceal Patients|Rate of Doppler assisted variceal patients who had complications within 30 days.
503821|NCT00746733|O1|Outcome|Vyvanse|
498425|NCT00732212|O2|Outcome|Doppler Non-variceal Group|Rate of Doppler assisted non-variceal patients who had complications within 30 days.
498426|NCT00732212|O1|Outcome|Standard Non-variceal Group|Rate of standard visually guided hemostasis non-variceal patients who had complications within 30 days.
498427|NCT00732212|O4|Outcome|Doppler Variceal Group|30 day rate of surgery in Doppler assisted variceal patients.
498428|NCT00732212|O3|Outcome|Standard Variceal Group|30 day rate of surgery in standard visually guided hemostasis variceal patients.
498429|NCT00732212|O2|Outcome|Doppler Non-variceal Group|30 day rate of surgery in Doppler assisted non-variceal patients.
498430|NCT00732212|O1|Outcome|Standard Non-variceal Group|30 day rate of surgery in standard visually guided hemostasis non-variceal patients.
498431|NCT00732212|O4|Outcome|Doppler Variceal Group|30 day rebleeding rate in Doppler assisted variceal patients.
498432|NCT00732212|O3|Outcome|Standard Variceal Group|30 day rebleeding rate in standard variceal visually guided hemostasis patients.
498433|NCT00732212|O2|Outcome|Doppler Non-variceal Group|30 day rebleeding rate in Doppler assisted non-variceal patients.
498927|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498434|NCT00732212|O1|Outcome|Standard Non-variceal Group|30 day rebleeding rate in standard non-variceal visually guided hemostasis patients.
498435|NCT00732212|E4|Reported Event|Doppler Variceal Group|Serious adverse events in Doppler variceal visually guided hemostasis patients.
498436|NCT00732212|E3|Reported Event|Standard Variceal Group|Serious adverse events in standard variceal visually guided hemostasis patients.
498437|NCT00732212|E2|Reported Event|Doppler Non-variceal Group|Serious adverse events in Doppler non-variceal patients.
498438|NCT00732212|E1|Reported Event|Standard Non-variceal Group|Serious adverse events in standard non-variceal visually guided hemostasis patients.
498439|NCT00732225|B6|Baseline|Total|Total of all reporting groups
498440|NCT00732225|B5|Baseline|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
498441|NCT00732225|B4|Baseline|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
498442|NCT00732225|B3|Baseline|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
498443|NCT00732225|B2|Baseline|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
498444|NCT00732225|B1|Baseline|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
498445|NCT00732225|P5|Participant Flow|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
498446|NCT00732225|P4|Participant Flow|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
498447|NCT00732225|P3|Participant Flow|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
498448|NCT00732225|P2|Participant Flow|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
498449|NCT00732225|P1|Participant Flow|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
498450|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
498451|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
498452|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
498453|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
498454|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
498455|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
498456|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
498457|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
498458|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
498459|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
498460|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
498461|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
498462|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
498463|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
498464|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
498465|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
498466|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
498467|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
498468|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
498469|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
498470|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
498471|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
498472|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
498473|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
498474|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
498475|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
498476|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
498477|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
498478|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
498479|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
498480|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
498481|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
498482|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
498483|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
498484|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
498485|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
498486|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
498487|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
498488|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
498489|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
498490|NCT00732225|E5|Reported Event|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
498491|NCT00732225|E4|Reported Event|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
498492|NCT00732225|E3|Reported Event|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
498493|NCT00732225|E2|Reported Event|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
498494|NCT00732225|E1|Reported Event|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
498495|NCT00732238|B3|Baseline|Total|Total of all reporting groups
498496|NCT00732238|B2|Baseline|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
498497|NCT00732238|B1|Baseline|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
498498|NCT00732238|P2|Participant Flow|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
498499|NCT00732238|P1|Participant Flow|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
498500|NCT00732238|O2|Outcome|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
498501|NCT00732238|O1|Outcome|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
498502|NCT00732238|O2|Outcome|Arm 2|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
498503|NCT00732238|O1|Outcome|Arm 1|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
498504|NCT00732238|E2|Reported Event|Arm 2|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
498505|NCT00732238|E1|Reported Event|Arm 1|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
498693|NCT00732758|P2|Participant Flow|Placebo Group|"Placebo Tablet
Placebo Tablet: Placebo Tablet once daily for 6 months"
498506|NCT00732303|B1|Baseline|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
Radiation Therapy:
Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
498529|NCT00732472|P3|Participant Flow|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
572697|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
498507|NCT00732303|P1|Participant Flow|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles
Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
Radiation Therapy:
Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
498508|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles
Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
Radiation Therapy:
Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
498509|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles
Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
Radiation Therapy:
Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
498510|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles
Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
Radiation Therapy:
Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
498511|NCT00732303|E1|Reported Event|Pemetrexed\Radiation|"Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
Radiation Therapy:
Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
498512|NCT00732381|B3|Baseline|Total|Total of all reporting groups
498513|NCT00732381|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
498514|NCT00732381|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
498515|NCT00732381|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
498516|NCT00732381|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
498517|NCT00732381|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
498518|NCT00732381|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
498519|NCT00732381|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
498520|NCT00732381|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
498521|NCT00732381|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
498522|NCT00732381|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
498523|NCT00732472|B5|Baseline|Total|Total of all reporting groups
498524|NCT00732472|B4|Baseline|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498525|NCT00732472|B3|Baseline|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498526|NCT00732472|B2|Baseline|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498527|NCT00732472|B1|Baseline|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498528|NCT00732472|P4|Participant Flow|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
499219|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
498530|NCT00732472|P2|Participant Flow|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498531|NCT00732472|P1|Participant Flow|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498532|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498533|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498534|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498535|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498536|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498537|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498538|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498539|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498540|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498541|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498542|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498543|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498544|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498545|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498546|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498547|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498548|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498549|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498550|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498551|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498552|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498553|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498554|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498555|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498556|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498830|NCT00733096|P3|Participant Flow|Saline|Two epidural saline injections
498557|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498558|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498559|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498560|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498561|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498562|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498563|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498564|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498565|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498566|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498567|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498568|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498569|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498570|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498571|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498572|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498573|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498574|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498575|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498576|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498577|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC19 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498578|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498579|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498580|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498581|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498582|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498583|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498584|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498585|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498586|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498587|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498588|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498695|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet
Placebo Tablet: Placebo Tablet once daily for 6 months"
498589|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498590|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498591|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498592|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498593|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498594|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498595|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498596|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498597|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498598|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498599|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498600|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498601|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498602|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498603|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498604|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498605|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498606|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498607|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498608|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498609|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498610|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498611|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498612|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498613|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498614|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498615|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498616|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498617|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498618|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498619|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498620|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498766|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498767|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498621|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498622|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498623|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498624|NCT00732472|E4|Reported Event|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
498625|NCT00732472|E3|Reported Event|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
498626|NCT00732472|E2|Reported Event|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
498627|NCT00732472|E1|Reported Event|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
498628|NCT00732615|B3|Baseline|Total|Total of all reporting groups
498629|NCT00732615|B2|Baseline|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
498630|NCT00732615|B1|Baseline|Placebo|Matching Placebo: Placebo for subcutaneous injection
498631|NCT00732615|P2|Participant Flow|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
498632|NCT00732615|P1|Participant Flow|Placebo|Matching Placebo: Placebo for subcutaneous injection
498633|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
498634|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
498635|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
498636|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
498637|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
498638|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
498639|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
498640|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
498641|NCT00732615|E2|Reported Event|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
498642|NCT00732615|E1|Reported Event|Placebo|Matching Placebo: Placebo for subcutaneous injection
498643|NCT00732641|B3|Baseline|Total|Total of all reporting groups
498644|NCT00732641|B2|Baseline|No Treatment|Participants were observed and received no treatment
498645|NCT00732641|B1|Baseline|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
498646|NCT00732641|P2|Participant Flow|No Treatment|Participants were observed and received no treatment
498647|NCT00732641|P1|Participant Flow|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
498648|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
498649|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
498650|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
498651|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
498652|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
498653|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
498654|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
498655|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
498656|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
498657|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
498658|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
498659|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
498660|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
498661|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
498662|NCT00732641|E2|Reported Event|No Treatment|Participants were observed and received no treatment
498663|NCT00732641|E1|Reported Event|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
498664|NCT00732654|B4|Baseline|Total|Total of all reporting groups
498665|NCT00732654|B3|Baseline|SLIT Group|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.
Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
498694|NCT00732758|P1|Participant Flow|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet
Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
498666|NCT00732654|B2|Baseline|OITB Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
498667|NCT00732654|B1|Baseline|OITA Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
498668|NCT00732654|P3|Participant Flow|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
498669|NCT00732654|P2|Participant Flow|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
498670|NCT00732654|P1|Participant Flow|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.
Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
498671|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
498672|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
498673|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.
Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
498674|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
498675|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
498676|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.
Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
498768|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498677|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
498702|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet
Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
498703|NCT00732758|E2|Reported Event|Placebo Group|"Placebo Tablet
Placebo Tablet: Placebo Tablet once daily for 6 months"
498678|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
498679|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.
Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
498680|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
498681|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
498682|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.
Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
498683|NCT00732654|E3|Reported Event|SLIT Group|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.
Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
498684|NCT00732654|E2|Reported Event|OITB Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
498685|NCT00732654|E1|Reported Event|OITA Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.
Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
498686|NCT00732680|B1|Baseline|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
498687|NCT00732680|P1|Participant Flow|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
498688|NCT00732680|O1|Outcome|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
498689|NCT00732680|E1|Reported Event|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
498690|NCT00732758|B3|Baseline|Total|Total of all reporting groups
498691|NCT00732758|B2|Baseline|Placebo Group|"Placebo Tablet
Placebo Tablet: Placebo Tablet once daily for 6 months"
498692|NCT00732758|B1|Baseline|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet
Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
498769|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498696|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet
Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
498697|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet
Placebo Tablet: Placebo Tablet once daily for 6 months"
498698|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet
Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
498699|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet
Placebo Tablet: Placebo Tablet once daily for 6 months"
498700|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet
Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
498701|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet
Placebo Tablet: Placebo Tablet once daily for 6 months"
498704|NCT00732758|E1|Reported Event|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet
Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
498705|NCT00732875|B1|Baseline|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
498706|NCT00732875|P1|Participant Flow|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
498707|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
498708|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
498709|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
498710|NCT00732875|E1|Reported Event|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
498711|NCT00732901|B3|Baseline|Total|Total of all reporting groups
498712|NCT00732901|B2|Baseline|B (Placebo)|Placebo once daily for days 1-28
498713|NCT00732901|B1|Baseline|A (Escitalopram)|Escitalopram: once daily 10 mg on days 1–3, 20 mg on days 4–24 and 10 mg on days 25–28
498714|NCT00732901|P2|Participant Flow|B (Placebo)|"Placebo
Placebo: once daily for days 1-28"
498715|NCT00732901|P1|Participant Flow|A (Escitalopram)|"Escitalopram
Escitalopram: once daily 10 mg on days 1–3, 20 mg on days 4–24 and 10 mg on days 25–28"
498716|NCT00732901|O2|Outcome|B (Placebo)|"Placebo
Placebo: daily for days 1-28"
498717|NCT00732901|O1|Outcome|A (Escitalopram)|"Escitalopram
Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28"
498718|NCT00732901|O2|Outcome|B (Placebo)|"Placebo
Placebo: daily for days 1-28"
498719|NCT00732901|O1|Outcome|A (Escitalopram)|"Escitalopram
Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28"
498720|NCT00732901|O2|Outcome|B (Placebo)|"Placebo
Placebo: daily for days 1-28"
498721|NCT00732901|O1|Outcome|A (Escitalopram)|"Escitalopram
Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28"
498722|NCT00732901|E2|Reported Event|B (Placebo)|"Placebo
Placebo: once daily for days 1-28"
498723|NCT00732901|E1|Reported Event|A (Escitalopram)|"Escitalopram
Escitalopram: once daily 10 mg on days 1–3, 20 mg on days 4–24 and 10 mg on days 25–28"
498724|NCT00732940|B3|Baseline|Total|Total of all reporting groups
498725|NCT00732940|B2|Baseline|Belimumab SC 3X/WK|
498726|NCT00732940|B1|Baseline|Belimumab SC Q2WKS|
498727|NCT00732940|P2|Participant Flow|Belimumab SC 3X/WK|200 mg of belimumab (2 subcutaneous injections of 100 mg each) on days 0, 2, and 4 then 100 mg three times a week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
498728|NCT00732940|P1|Participant Flow|Belimumab SC Q2WKS|100 mg of belimumab (1 subcutaneous injection) on days 0, 7, and 14, then every other week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
498729|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498730|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498731|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498732|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498733|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498734|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498735|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498736|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498737|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498738|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498739|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498740|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498741|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498742|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498743|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498744|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498745|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498746|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498747|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498748|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498749|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498750|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498751|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498752|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498753|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498754|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498755|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498756|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498757|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498758|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498759|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498760|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498761|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498762|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498763|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498764|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
498765|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
498793|NCT00732940|E2|Reported Event|Belimumab SC 3X/WK|The 3x/wk group will receive 200 mg of belimumab (2 injections of 100 mg each) plus standard therapy on Days 0, 2, and 4 and then 100 mg (1 injection) 3 times per week thereafter.
498794|NCT00732940|E1|Reported Event|Belimumab SC Q2WKS|The Q2wk group will receive 100 mg of belimumab (1 injection) plus standard therapy on Days 0, 7, 14, and then every 2 weeks thereafter.
498795|NCT00732992|B3|Baseline|Total|Total of all reporting groups
498796|NCT00732992|B2|Baseline|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.
Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
498797|NCT00732992|B1|Baseline|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498798|NCT00732992|P2|Participant Flow|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.
Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
498799|NCT00732992|P1|Participant Flow|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498800|NCT00732992|O2|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.
Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
498801|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498802|NCT00732992|O1|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.
Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
498803|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498804|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498805|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498806|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498807|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498808|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498809|NCT00732992|O1|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.
Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
498810|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498811|NCT00732992|O2|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.
Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
498812|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498813|NCT00732992|E2|Reported Event|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.
Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
498814|NCT00732992|E1|Reported Event|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
498815|NCT00733005|B3|Baseline|Total|Total of all reporting groups
498816|NCT00733005|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
498817|NCT00733005|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
498818|NCT00733005|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
498819|NCT00733005|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
498820|NCT00733005|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
498821|NCT00733005|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
498822|NCT00733005|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
498823|NCT00733005|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
498824|NCT00733005|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
498825|NCT00733005|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
498826|NCT00733096|B4|Baseline|Total|Total of all reporting groups
498827|NCT00733096|B3|Baseline|Saline|Two epidural saline injections
498831|NCT00733096|P2|Participant Flow|Etanercept|Two epidural etanercept injections
498832|NCT00733096|P1|Participant Flow|Steroid|Two epidural steroid injections
498833|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
498834|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
498835|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
498836|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
498837|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
498838|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
498839|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
498840|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
498841|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
498848|NCT00733135|B1|Baseline|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
498849|NCT00733135|P1|Participant Flow|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
498850|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
498851|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
498852|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
498853|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk™ plaque excision systems with the SpiderFX™ embolic protection device placed distally.
498854|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
498855|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
498856|NCT00733135|E1|Reported Event|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
498857|NCT00733226|B3|Baseline|Total|Total of all reporting groups
498858|NCT00733226|B2|Baseline|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
498859|NCT00733226|B1|Baseline|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
498860|NCT00733226|P2|Participant Flow|Placebo Group|The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
498861|NCT00733226|P1|Participant Flow|Broncho-Vaxom Group|The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
498862|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
498863|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
498864|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
498865|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
498866|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
498867|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
498868|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
498869|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
498870|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
498871|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
498872|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
498873|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
503822|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
498874|NCT00733226|E2|Reported Event|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
498875|NCT00733226|E1|Reported Event|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
498876|NCT00733278|B1|Baseline|IUD Placement|
498877|NCT00733278|P1|Participant Flow|Copper IUD|Women undergoing elective C-section who request long-term contraception with Copper IUD.
498878|NCT00733278|O1|Outcome|IUD Strings|Visibility of IUD strings within the vagina at all times.
498879|NCT00733278|O1|Outcome|IUD Placement|IUD placement following removal of placenta at time of elective C-section
498880|NCT00733278|E1|Reported Event|Copper IUD|Women undergoing elective C-section who request long-term contraception with Copper IUD.
498881|NCT00733291|B3|Baseline|Total|Total of all reporting groups
498882|NCT00733291|B2|Baseline|Etafilcon A Contact Lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
498883|NCT00733291|B1|Baseline|Nelfilcon A Contact Lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
499220|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
498884|NCT00733291|P4|Participant Flow|Etafilcon A no Soak / Etafilcon Soak|Etafilcon A contact lenses inserted directly out of the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
498885|NCT00733291|P3|Participant Flow|Etafilcon A Soak / Etafilcon A no Soak|Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
498886|NCT00733291|P2|Participant Flow|Nelfilcon A no Soak / Nelfilcon A Soak|Nelfilcon A contact lenses inserted directly out of the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
498887|NCT00733291|P1|Participant Flow|Nelfilcon A Soak / Nelfilcon A no Soak|Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
498888|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
498889|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
498890|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
498891|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
498892|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
498893|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
498894|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
498895|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
498896|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
498897|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
498898|NCT00733291|O2|Outcome|Nelfilcon A / No Soak|Nelfilcon A contact lenses inserted directly out of the blister package
498899|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
498900|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
498901|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
498902|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
498903|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
498904|NCT00733291|E4|Reported Event|Etafilcon / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
498905|NCT00733291|E3|Reported Event|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
498906|NCT00733291|E2|Reported Event|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
498907|NCT00733291|E1|Reported Event|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
498908|NCT00733330|B3|Baseline|Total|Total of all reporting groups
498909|NCT00733330|B2|Baseline|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498910|NCT00733330|B1|Baseline|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
498911|NCT00733330|P2|Participant Flow|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498912|NCT00733330|P1|Participant Flow|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498913|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498914|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498915|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498916|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
503823|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
498917|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498918|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498919|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498920|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498921|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498922|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498923|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498924|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498925|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498926|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498928|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498929|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498930|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498931|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498932|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498933|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498934|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498935|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498936|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498937|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498938|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498939|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498940|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498941|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498942|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498943|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498944|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498945|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498946|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498947|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498948|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498949|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498950|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498951|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498952|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498953|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498954|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498955|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498956|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498957|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498958|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498959|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498960|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498961|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498962|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498963|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498964|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498965|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498966|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498967|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498968|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498969|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498970|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498971|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498972|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498973|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498974|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498975|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498976|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
499016|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
498977|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498978|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
498979|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498980|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
498981|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498982|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
498983|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498984|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
498985|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498986|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
498987|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498988|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
498989|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498990|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
498991|NCT00733330|E2|Reported Event|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
498992|NCT00733330|E1|Reported Event|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
498993|NCT00733369|B3|Baseline|Total|Total of all reporting groups
498994|NCT00733369|B2|Baseline|PFC Sigma RP|"125 patients to be allocated to this arm according to blinding envelopes
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing"
498995|NCT00733369|B1|Baseline|PFC Sigma RP-F|"125 patients to be allocated to this arm according to blinding envelopes
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing"
498996|NCT00733369|P2|Participant Flow|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
498997|NCT00733369|P1|Participant Flow|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
498998|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
498999|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499000|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499001|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499002|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499003|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499004|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499005|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499006|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499007|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499146|NCT00733512|B1|Baseline|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
499008|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499009|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499010|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499011|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499012|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499013|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499014|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499015|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499017|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499018|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499019|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499020|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499021|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499022|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499023|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499024|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499025|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499026|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499027|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499028|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499029|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499030|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499031|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499032|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499033|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499034|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499035|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499036|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499037|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499038|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499039|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499040|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499041|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499042|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499043|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499044|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499045|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499046|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499047|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499048|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499049|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499050|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
503824|NCT00746733|O2|Outcome|Adderall XR|
499051|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499052|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499053|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499054|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499055|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499056|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499057|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499058|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499059|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499060|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499061|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499062|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499063|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499064|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499065|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499066|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499067|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499068|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499069|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499070|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499071|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499072|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499073|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499074|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499075|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499076|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499077|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499078|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499079|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499080|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499081|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499082|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499083|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499084|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499085|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499086|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499087|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499088|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499089|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499090|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499091|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499092|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499093|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
503825|NCT00746733|O1|Outcome|Vyvanse|
499094|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499095|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499096|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499097|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499098|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499099|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499100|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499101|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499102|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499103|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499104|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499105|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499106|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499107|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499108|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499109|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499110|NCT00733369|E2|Reported Event|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
499111|NCT00733369|E1|Reported Event|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
499112|NCT00733421|B3|Baseline|Total|Total of all reporting groups
499113|NCT00733421|B2|Baseline|Control Tramadol|Tramadol 100 mg slow release twice daily
499114|NCT00733421|B1|Baseline|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499115|NCT00733421|P2|Participant Flow|Control Tramadol|Tramadol 100 mg slow release twice daily
499116|NCT00733421|P1|Participant Flow|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499117|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
499118|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499119|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
499120|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499121|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
499122|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499123|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
499124|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499125|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
499126|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499127|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
499128|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499129|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
499130|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499131|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
499132|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499133|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
499134|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499135|NCT00733421|E2|Reported Event|Control Tramadol|Tramadol 100 mg slow release twice daily
499136|NCT00733421|E1|Reported Event|Etoricoxib|"Active study drug:
Etoricoxib 90 mg once daily"
499137|NCT00733499|B3|Baseline|Total|Total of all reporting groups
499138|NCT00733499|B2|Baseline|LCS Complete Porocoat|102 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
499139|NCT00733499|B1|Baseline|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
499140|NCT00733499|P2|Participant Flow|LCS Complete Porocoat|103 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
499141|NCT00733499|P1|Participant Flow|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
499142|NCT00733499|O2|Outcome|LCS Complete Porocoat|102 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
499143|NCT00733499|O1|Outcome|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
499144|NCT00733499|E2|Reported Event|LCS Complete Porocoat|103 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
499145|NCT00733499|E1|Reported Event|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
499147|NCT00733512|P1|Participant Flow|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
499148|NCT00733512|O1|Outcome|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
499149|NCT00733512|O1|Outcome|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
499150|NCT00733512|E1|Reported Event|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
499151|NCT00733746|B1|Baseline|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
499167|NCT00733824|P3|Participant Flow|Phase I - Cohort 3|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499152|NCT00733746|P1|Participant Flow|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
499153|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
499154|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
499155|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
499156|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
499157|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
499158|NCT00733746|E1|Reported Event|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
499159|NCT00733824|B6|Baseline|Total|Total of all reporting groups
499160|NCT00733824|B5|Baseline|Phase II|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499161|NCT00733824|B4|Baseline|Cohort 4|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499162|NCT00733824|B3|Baseline|Cohort 3|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499199|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499163|NCT00733824|B2|Baseline|Cohort 2|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499164|NCT00733824|B1|Baseline|Cohort 1|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499165|NCT00733824|P5|Participant Flow|Phase II|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499166|NCT00733824|P4|Participant Flow|Phase I - Cohort 4|240 µg/kg SC AMD3100 Day -5 10 µg/kg SC G-CSF Day -4 thru Day -1 400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1 Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
499212|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499168|NCT00733824|P2|Participant Flow|Phase I - Cohort 2|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499169|NCT00733824|P1|Participant Flow|Phase I - Cohort 1|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499170|NCT00733824|O5|Outcome|Phase II|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
AMD3100
G-CSF
Apheresis"
499171|NCT00733824|O4|Outcome|Cohort 4|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499172|NCT00733824|O3|Outcome|Cohort 3|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499173|NCT00733824|O2|Outcome|Cohort 2|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499174|NCT00733824|O1|Outcome|Cohort 1|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499175|NCT00733824|O1|Outcome|Phase 1 and Phase 2 Participants|
499176|NCT00733824|O1|Outcome|Phase 1 and Phase 2 Participants|
499177|NCT00733824|O4|Outcome|Cohort 4|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499178|NCT00733824|O3|Outcome|Cohort 3|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499179|NCT00733824|O2|Outcome|Cohort 2|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499180|NCT00733824|O1|Outcome|Cohort 1|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499181|NCT00733824|O1|Outcome|Phase 1 (Dose Levels 1-4)|
499182|NCT00733824|E5|Reported Event|Phase II|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499183|NCT00733824|E4|Reported Event|Cohort 4|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499184|NCT00733824|E3|Reported Event|Cohort 3|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499185|NCT00733824|E2|Reported Event|Cohort 2|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499186|NCT00733824|E1|Reported Event|Cohort 1|"240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
499187|NCT00733954|B3|Baseline|Total|Total of all reporting groups
499188|NCT00733954|B2|Baseline|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499189|NCT00733954|B1|Baseline|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499190|NCT00733954|P2|Participant Flow|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499191|NCT00733954|P1|Participant Flow|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499192|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499193|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499194|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499195|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499196|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499197|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499198|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499200|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499201|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499202|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499203|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499204|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499205|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499206|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499207|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499208|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499209|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499210|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499211|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
572698|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
499221|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499222|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499223|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499224|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499225|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499226|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499227|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499228|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499229|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499230|NCT00733954|E2|Reported Event|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
499231|NCT00733954|E1|Reported Event|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
499232|NCT00733993|B3|Baseline|Total|Total of all reporting groups
499233|NCT00733993|B2|Baseline|Control Participants|Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
499234|NCT00733993|B1|Baseline|Cocaine Users|Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
499235|NCT00733993|P2|Participant Flow|Control Participants|"Control participants were allocated to different sequence orders for the 5 interventions
Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
499236|NCT00733993|P1|Participant Flow|Cocaine Users|"Cocaine users were allocated to different sequence orders for the 5 interventions
Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
499237|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
499238|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
499239|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
499240|NCT00733993|O1|Outcome|Placebo|"Placebo
Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
499241|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
499242|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
499243|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
499244|NCT00733993|O1|Outcome|Placebo|"Placebo
Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
499245|NCT00733993|O4|Outcome|Amphetamine 20 mg|Amphetamine 20 mg
499246|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300 mg
499247|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
499248|NCT00733993|O1|Outcome|Placebo|"Placebo
Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
499249|NCT00733993|O4|Outcome|Amphetamine 20 mg|Amphetamine 20 mg
499250|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300 mg
499251|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
499252|NCT00733993|O1|Outcome|Placebo|"Placebo
Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
499253|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
499254|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
499255|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
499256|NCT00733993|O1|Outcome|Placebo|"Placebo
Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
499257|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
499258|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
499259|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
499260|NCT00733993|O1|Outcome|Placebo|"Placebo
Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
499261|NCT00733993|O4|Outcome|Amphetamine 20 mg|Amphetamine 20 mg
499262|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300 mg
499263|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
499264|NCT00733993|O1|Outcome|Placebo|"Placebo
Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
499265|NCT00733993|E3|Reported Event|3 Amphetamine|Amphetamine: Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
499266|NCT00733993|E2|Reported Event|2 Placebo|"Placebo
Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
499267|NCT00733993|E1|Reported Event|1 Caffeine|"Caffeine
Caffeine: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
499268|NCT00734071|B3|Baseline|Total|Total of all reporting groups
499269|NCT00734071|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499270|NCT00734071|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499271|NCT00734071|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499272|NCT00734071|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499273|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499274|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499275|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499276|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499277|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499278|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499279|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499280|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499281|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499282|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499283|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499284|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499285|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499286|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499287|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499288|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499289|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499290|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499291|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499292|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499293|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499294|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499295|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499296|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499297|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499298|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499299|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499300|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499301|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499302|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499303|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499304|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499305|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499306|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499307|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499308|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499309|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499310|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
503826|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
499311|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499312|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499313|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499314|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499315|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499316|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499317|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499318|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499319|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499320|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499321|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499322|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499323|NCT00734071|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
499324|NCT00734071|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
499325|NCT00725452|B1|Baseline|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
499861|NCT00727194|O2|Outcome|Placebo|All patients who received study treatment(s)
499326|NCT00725452|P1|Participant Flow|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
499327|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
499328|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
499329|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
499330|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
499331|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
499332|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
499333|NCT00725452|E1|Reported Event|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
499334|NCT00725491|B3|Baseline|Total|Total of all reporting groups
499335|NCT00725491|B2|Baseline|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
499336|NCT00725491|B1|Baseline|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
499337|NCT00725491|P2|Participant Flow|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
499338|NCT00725491|P1|Participant Flow|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
499339|NCT00725491|O2|Outcome|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
499340|NCT00725491|O1|Outcome|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
499341|NCT00725491|E2|Reported Event|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
499342|NCT00725491|E1|Reported Event|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
499343|NCT00725504|B1|Baseline|Lidocaine Infusion|"Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml.
Intravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml"
499344|NCT00725504|P1|Participant Flow|Lidocaine Infusion|"Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml.
Intravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml"
499345|NCT00725504|O4|Outcome|Lidocaine 5 µg/ml|Each participant received an intravenous infusion of 5 µg/ml of lidocaine.
499346|NCT00725504|O3|Outcome|Lidocaine 3 µg/ml|Each participant received an intravenous infusion of 3 µg/ml of lidocaine.
499347|NCT00725504|O2|Outcome|Placebo|Each participant received a placebo-saline infusion.
499348|NCT00725504|O1|Outcome|Baseline|Each participant was tested at the zero infusion rate.
499349|NCT00725504|E1|Reported Event|Lidocaine Infusion|Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.
499350|NCT00725530|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
500410|NCT00734994|E1|Reported Event|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
499351|NCT00725530|P2|Participant Flow|Etafilcon A / Balafilcon A|Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
499352|NCT00725530|P1|Participant Flow|Balafilcon A / Etafilcon A|Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
499353|NCT00725530|O2|Outcome|Etafilcon A|Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
499354|NCT00725530|O1|Outcome|Balafilcon A|Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
499355|NCT00725530|E2|Reported Event|Etafilcon A|Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
499356|NCT00725530|E1|Reported Event|Balafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
499357|NCT00725543|B1|Baseline|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
499358|NCT00725543|P1|Participant Flow|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
499453|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499359|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
499360|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
499361|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
499362|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
499363|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
499364|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
499365|NCT00725543|E1|Reported Event|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
499366|NCT00725608|B1|Baseline|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
499367|NCT00725608|P1|Participant Flow|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
499368|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
499369|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
499370|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
499371|NCT00725608|E1|Reported Event|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
499372|NCT00725621|B1|Baseline|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499444|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
500451|NCT00735371|B5|Baseline|Total|Total of all reporting groups
499373|NCT00725621|P1|Participant Flow|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
499374|NCT00725621|O2|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499375|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499376|NCT00725621|O2|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499862|NCT00727194|O1|Outcome|Eculizumab|All patients who received study treatment(s)
499377|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499378|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499379|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499380|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499381|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499382|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499383|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499384|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499385|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499386|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499403|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499387|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499388|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499389|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499390|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499391|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499392|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499393|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499394|NCT00725621|E1|Reported Event|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
499395|NCT00725712|B3|Baseline|Total|Total of all reporting groups
499396|NCT00725712|B2|Baseline|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499397|NCT00725712|B1|Baseline|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499398|NCT00725712|P2|Participant Flow|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499399|NCT00725712|P1|Participant Flow|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 milligram (mg) per dosing day orally, on 5 days on and 9 days off cycle every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose
499400|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499401|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499402|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm
499441|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499966|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499404|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499405|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499406|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499407|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499454|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499408|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499409|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499410|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499411|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499412|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499413|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499414|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499415|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499416|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499417|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 & 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499418|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499419|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499442|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499443|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499420|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499421|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499422|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 and 9 dosing arm.
499455|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499456|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
500345|NCT00734799|P1|Participant Flow|Wait List|Usual Care/Wait-List Control
499423|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200 mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499424|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499425|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499426|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499427|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499428|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499429|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200 mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499430|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
499431|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499432|NCT00725712|E2|Reported Event|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 and 9 dosing arm.
499433|NCT00725712|E1|Reported Event|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally ( viz. foretinib solid capsules of 20, 100 and 200 mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
499434|NCT00725725|B4|Baseline|Total|Total of all reporting groups
499435|NCT00725725|B3|Baseline|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499436|NCT00725725|B2|Baseline|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499437|NCT00725725|B1|Baseline|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499438|NCT00725725|P3|Participant Flow|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499439|NCT00725725|P2|Participant Flow|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499440|NCT00725725|P1|Participant Flow|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499445|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499446|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499447|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499448|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499449|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499450|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499451|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499452|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499457|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499458|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499459|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499460|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499461|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499462|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499463|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499464|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499465|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499466|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499467|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499468|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499469|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499470|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499471|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499472|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499473|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499474|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499475|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499476|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499477|NCT00725725|E3|Reported Event|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
499478|NCT00725725|E2|Reported Event|Org 25935 12 mg|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
499479|NCT00725725|E1|Reported Event|Org 25935 4 mg|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
499480|NCT00725751|B3|Baseline|Total|Total of all reporting groups
499481|NCT00725751|B2|Baseline|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
499482|NCT00725751|B1|Baseline|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
499483|NCT00725751|P2|Participant Flow|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
499484|NCT00725751|P1|Participant Flow|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
499485|NCT00725751|O1|Outcome|All Participants|"Participants who received at least one dose of antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
Participants who received at least one dose of antiviral treatment and did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)"
500452|NCT00735371|B4|Baseline|Placebo|Placebo
499486|NCT00725751|O2|Outcome|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
499487|NCT00725751|O1|Outcome|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
499488|NCT00725751|O2|Outcome|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
499489|NCT00725751|O1|Outcome|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
499490|NCT00725751|E2|Reported Event|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
499491|NCT00725751|E1|Reported Event|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
499492|NCT00725842|B1|Baseline|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
500346|NCT00734799|O2|Outcome|Intervention|Sleep Intervention for PTSD (SIP)
499493|NCT00725842|P1|Participant Flow|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
499494|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
499495|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
499496|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
499497|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
499498|NCT00725842|E1|Reported Event|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
499499|NCT00725920|B3|Baseline|Total|Total of all reporting groups
499500|NCT00725920|B2|Baseline|Control Group|patients received pills content placebo, that were identical to the pills content active drug
499501|NCT00725920|B1|Baseline|Topiramate|patients receiving the active drug: topiramate
499502|NCT00725920|P2|Participant Flow|Control Group|patients receiving placebo pills, that were identical to the pills content active drug, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
499503|NCT00725920|P1|Participant Flow|Topiramate|patients receiving the active drug: topiramate. Patients will receive topiramate pills, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
499504|NCT00725920|O2|Outcome|Control Group|patients received pills content placebo, that were identical to the pills content active drug
499505|NCT00725920|O1|Outcome|Topiramate|patients receiving the active drug: topiramate
499506|NCT00725920|E2|Reported Event|Control Group|patients received pills content placebo, that were identical to the pills content active drug
499507|NCT00725920|E1|Reported Event|Topiramate|patients receiving the active drug: topiramate
499508|NCT00725985|B4|Baseline|Total|Total of all reporting groups
499509|NCT00725985|B3|Baseline|Placebo|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
499510|NCT00725985|B2|Baseline|Cladribine 3.5 mg/kg|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in (LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
499807|NCT00727025|B1|Baseline|All Participants|Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure.
499511|NCT00725985|B1|Baseline|Cladribine 5.25 mg/kg|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in (LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
499512|NCT00725985|P12|Participant Flow|Placebo, Rebif (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499528|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499513|NCT00725985|P11|Participant Flow|Cladribine 3.5 mg/kg, Rebif (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499514|NCT00725985|P10|Participant Flow|Cladribine 5.25 mg/kg, Rebif (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499515|NCT00725985|P9|Participant Flow|Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499516|NCT00725985|P8|Participant Flow|Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499517|NCT00725985|P7|Participant Flow|Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499518|NCT00725985|P6|Participant Flow|Placebo, Rebif (OLMP)|Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
499519|NCT00725985|P5|Participant Flow|Cladribine 3.5 mg/kg, Rebif (OLMP)|Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
499520|NCT00725985|P4|Participant Flow|Cladribine 5.25 mg/kg, Rebif (OLMP)|Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
499521|NCT00725985|P3|Participant Flow|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499522|NCT00725985|P2|Participant Flow|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499523|NCT00725985|P1|Participant Flow|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the initial treatment period (ITP) of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
499900|NCT00727246|B5|Baseline|Total|Total of all reporting groups
503827|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
499524|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499525|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499526|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499527|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499529|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499530|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499531|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499532|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499533|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499534|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499535|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499536|NCT00725985|E12|Reported Event|Placebo, Rebif (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499537|NCT00725985|E11|Reported Event|Cladribine 3.5 mg/kg, Rebif (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499538|NCT00725985|E10|Reported Event|Cladribine 5.25 mg/kg, Rebif (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499539|NCT00725985|E9|Reported Event|Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499564|NCT00726180|O1|Outcome|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
499540|NCT00725985|E8|Reported Event|Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499541|NCT00725985|E7|Reported Event|Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
499778|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499542|NCT00725985|E6|Reported Event|Placebo, Rebif (OLMP)|Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
499543|NCT00725985|E5|Reported Event|Cladribine 3.5 mg/kg, Rebif (OLMP)|Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
499544|NCT00725985|E4|Reported Event|Cladribine 5.25 mg/kg, Rebif (OLMP)|Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
499545|NCT00725985|E3|Reported Event|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499546|NCT00725985|E2|Reported Event|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
499547|NCT00725985|E1|Reported Event|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the initial treatment period (ITP) of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
499548|NCT00726037|B1|Baseline|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
499549|NCT00726037|P1|Participant Flow|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
499550|NCT00726037|O1|Outcome|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
499551|NCT00726037|O1|Outcome|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
499552|NCT00726037|E1|Reported Event|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
499553|NCT00726063|B3|Baseline|Total|Total of all reporting groups
499554|NCT00726063|B2|Baseline|Osseotite Implant|"Osseotite dental implant
Osseotite dental implant : Osseotite Root form titanium dental implant"
499555|NCT00726063|B1|Baseline|Nanotite Implant|"Nanotite dental implant
Nanotite dental implant : Nanotite root form titanium dental implant"
499556|NCT00726063|P2|Participant Flow|Osseotite Implant|"Osseotite dental implant
Osseotite dental implant : Osseotite Root form titanium dental implant"
499557|NCT00726063|P1|Participant Flow|Nanotite Implant|"Nanotite dental implant
Nanotite dental implant : Nanotite root form titanium dental implant"
499558|NCT00726063|O2|Outcome|Osseotite Implant|"Osseotite dental implant
Osseotite dental implant : Osseotite Root form titanium dental implant"
499559|NCT00726063|O1|Outcome|Nanotite Implant|"Nanotite dental implant
Nanotite dental implant : Nanotite root form titanium dental implant"
499560|NCT00726063|E2|Reported Event|Osseotite Implant|"Osseotite dental implant
Osseotite dental implant : Osseotite Root form titanium dental implant"
499561|NCT00726063|E1|Reported Event|Nanotite Implant|"Nanotite dental implant
Nanotite dental implant : Nanotite root form titanium dental implant"
499562|NCT00726180|B1|Baseline|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
499563|NCT00726180|P1|Participant Flow|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
503828|NCT00746733|O2|Outcome|Adderall XR|
499565|NCT00726180|E1|Reported Event|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
499566|NCT00726232|B7|Baseline|Total|Total of all reporting groups
499567|NCT00726232|B6|Baseline|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499681|NCT00726661|B2|Baseline|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499568|NCT00726232|B5|Baseline|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499569|NCT00726232|B4|Baseline|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499570|NCT00726232|B3|Baseline|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499571|NCT00726232|B2|Baseline|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499572|NCT00726232|B1|Baseline|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499573|NCT00726232|P6|Participant Flow|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499574|NCT00726232|P5|Participant Flow|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499575|NCT00726232|P4|Participant Flow|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499576|NCT00726232|P3|Participant Flow|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499577|NCT00726232|P2|Participant Flow|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499578|NCT00726232|P1|Participant Flow|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499967|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499579|NCT00726232|O6|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499580|NCT00726232|O5|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499682|NCT00726661|B1|Baseline|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499581|NCT00726232|O4|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499582|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499583|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499584|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499585|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499586|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499587|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499588|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499589|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499590|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499591|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499592|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499593|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499594|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499595|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499596|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499597|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499598|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499599|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499600|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499601|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499602|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499603|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499604|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499605|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499606|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499607|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499608|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499609|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499610|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499611|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499612|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499613|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499614|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499615|NCT00726232|E6|Reported Event|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499616|NCT00726232|E5|Reported Event|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499617|NCT00726232|E4|Reported Event|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499618|NCT00726232|E3|Reported Event|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499619|NCT00726232|E2|Reported Event|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499640|NCT00726453|P2|Participant Flow|38 mm Length Sub-study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
499968|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499620|NCT00726232|E1|Reported Event|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
499642|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
499621|NCT00726375|B1|Baseline|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose
Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
499622|NCT00726375|P1|Participant Flow|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose
Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
499623|NCT00726375|O1|Outcome|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose
Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
499624|NCT00726375|O1|Outcome|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose
Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
499625|NCT00726375|E1|Reported Event|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose
Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
499626|NCT00726414|B1|Baseline|Quinine Sulfate Under Fed and Fasted Conditions|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast or 30 minutes following a standardized, high fat breakfast.
499627|NCT00726414|P2|Participant Flow|Quinine Sulfate Under Fed Then Fasted Conditions|On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
499628|NCT00726414|P1|Participant Flow|Quinine Sulfate Under Fasted Then Fed Conditions|On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast.
499629|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
499630|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499631|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
499632|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499633|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
499634|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499635|NCT00726414|E2|Reported Event|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
499636|NCT00726414|E1|Reported Event|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499637|NCT00726453|B3|Baseline|Total|Total of all reporting groups
499638|NCT00726453|B2|Baseline|38 mm Length Sub-study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed. This sub-study completed the primary endpoint in March 2012 results not yet available.
499639|NCT00726453|B1|Baseline|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
503829|NCT00746733|O1|Outcome|Vyvanse|
499641|NCT00726453|P1|Participant Flow|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
499643|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
499644|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
499645|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
499646|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
499647|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
499648|NCT00726453|E2|Reported Event|38 mm Length Sub-Study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
499649|NCT00726453|E1|Reported Event|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study and are collectively referred to as the Primary Enrollment Group (PEG)."
499650|NCT00726557|B1|Baseline|PegIntron + Rebetol|Baseline measures only available for the 118 participants who completed.
499651|NCT00726557|P1|Participant Flow|PegIntron + Rebetol|PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
499652|NCT00726557|O1|Outcome|Participants Who Tolerated Treatment|Those who completed treatment.
499653|NCT00726557|O1|Outcome|Participants With Negative HCV-RNA at End of Treatment|End of treatment is 24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4
499654|NCT00726557|E1|Reported Event|PegIntron + Rebetol|PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
499655|NCT00726609|B1|Baseline|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.
Prophylaxis of invasive fungal infection."
499656|NCT00726609|P1|Participant Flow|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.
Prophylaxis of invasive fungal infection."
499657|NCT00726609|O1|Outcome|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.
Prophylaxis of invasive fungal infection."
499658|NCT00726609|E1|Reported Event|Posaconazole (Assigned by Physician in Normal Practice)|
499659|NCT00726622|B3|Baseline|Total|Total of all reporting groups
499660|NCT00726622|B2|Baseline|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
499661|NCT00726622|B1|Baseline|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
499705|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
503830|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
499662|NCT00726622|P2|Participant Flow|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
499663|NCT00726622|P1|Participant Flow|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
500347|NCT00734799|O1|Outcome|Wait List|Usual Care/Wait-List Control
499664|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
499665|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
499666|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
499667|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
499668|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
499669|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
499670|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
499671|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
499672|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
499673|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
499674|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
499675|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
499676|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
499677|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
499678|NCT00726622|E2|Reported Event|Arm 2: Laparoscopic-assisted Rectal Resection|Laparoscopic-assisted rectal resection: Patients undergo laparoscopic-assisted rectal resection.
499679|NCT00726622|E1|Reported Event|Arm 1: Open Laparotomy and Rectal Resection|Open laparotomy and rectal resection: Patients undergo open laparotomy and rectal resection.
499680|NCT00726661|B3|Baseline|Total|Total of all reporting groups
499713|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
499683|NCT00726661|P2|Participant Flow|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499684|NCT00726661|P1|Participant Flow|Chemotherapy Cohort|Eligible participants with human epidermal growth factor receptor 2-negative (HER2-negative) disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499685|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499686|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499687|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499688|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499689|NCT00726661|O1|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499690|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499691|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499692|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499693|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499694|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499695|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499696|NCT00726661|E2|Reported Event|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499697|NCT00726661|E1|Reported Event|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
499698|NCT00726713|B3|Baseline|Total|Total of all reporting groups
499699|NCT00726713|B2|Baseline|Placebo|Placebo one tablet twice a day
499700|NCT00726713|B1|Baseline|Metanx|Metanx one tablet twice a day
499701|NCT00726713|P2|Participant Flow|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
499702|NCT00726713|P1|Participant Flow|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499703|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
499704|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499706|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499707|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
499708|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499709|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
499710|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499711|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
499712|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499714|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499715|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
499716|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499717|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
499718|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499719|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
499720|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499721|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
499722|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499723|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
499724|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
499725|NCT00726713|E2|Reported Event|Placebo|Placebo one tablet twice a day
499726|NCT00726713|E1|Reported Event|Metanx|Metanx one tablet twice a day
499727|NCT00726739|B3|Baseline|Total|Total of all reporting groups
499728|NCT00726739|B2|Baseline|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
499729|NCT00726739|B1|Baseline|Arm I and III Crossover Group - LMI + Aldesleukin|"Includes 6 patients who progressed and crossed over from Arm II."
499730|NCT00726739|P2|Participant Flow|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
499731|NCT00726739|P1|Participant Flow|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
499732|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
499733|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II. Both KLH and DTH are tests assessing the ability to respond to immune therapy. These are independent tests and there is no bearing of KLH response on DTH response."
499734|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
499735|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
499736|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
499969|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499737|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
499738|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
499739|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
499740|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
499776|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499741|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
499742|NCT00726739|E2|Reported Event|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on arm I.
499743|NCT00726739|E1|Reported Event|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
499744|NCT00726752|B1|Baseline|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499745|NCT00726752|P1|Participant Flow|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499746|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499747|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499748|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499749|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499750|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499751|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499772|NCT00726882|E1|Reported Event|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.
Participants received no treatment in this follow-up study."
499901|NCT00727246|B4|Baseline|Control Participants Who Received Placebo|Participants without a history of TBI who were randomized to receive placebo
499752|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499753|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499777|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
572699|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
499754|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499755|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499756|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499757|NCT00726752|E1|Reported Event|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
499758|NCT00726830|B3|Baseline|Total|Total of all reporting groups
499759|NCT00726830|B2|Baseline|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
499760|NCT00726830|B1|Baseline|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
499761|NCT00726830|P2|Participant Flow|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
499762|NCT00726830|P1|Participant Flow|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
499763|NCT00726830|O2|Outcome|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
499764|NCT00726830|O1|Outcome|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
499765|NCT00726830|E2|Reported Event|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
499766|NCT00726830|E1|Reported Event|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
499767|NCT00726882|B1|Baseline|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.
Participants received no treatment in this follow-up study."
499768|NCT00726882|P1|Participant Flow|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.
Participants received no treatment in this follow-up study."
499769|NCT00726882|O1|Outcome|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.
Participants received no treatment in this follow-up study."
499770|NCT00726882|O2|Outcome|Participants From Study M10-351|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level in the prior clinical study (NCT00696904/M10-351) involving ABT−333.
Participants received no treatment in this follow-up study."
499771|NCT00726882|O1|Outcome|Participants From Study M10-380|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level in the prior clinical study (NCT00851890/M10-380) involving ABT−333.
Participants received no treatment in this follow-up study."
499806|NCT00726999|E1|Reported Event|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
503831|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
499773|NCT00726895|B1|Baseline|Entire Study Population|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received either one Quinine Sulfate 324 mg capsule or two Quinine Sulfate 324 mg capsules following an overnight fast of at least 10 hours.
499774|NCT00726895|P2|Participant Flow|Quinine Sulfate Capsules 2 x 324 mg Dose Then 1 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
499775|NCT00726895|P1|Participant Flow|Quinine Sulfate Capsules 1 x 324 mg Dose Then 2 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
499779|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499780|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
499781|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499782|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499783|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
499784|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499785|NCT00726895|E2|Reported Event|Treatment B - Quinine Sulfate Capsules 2 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
499786|NCT00726895|E1|Reported Event|Treatment A - Quinine Sulfate Capsules 1 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
499787|NCT00726986|B1|Baseline|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
499788|NCT00726986|P1|Participant Flow|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
499789|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
499790|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
499791|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
499792|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
499793|NCT00726986|E1|Reported Event|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
499794|NCT00726999|B3|Baseline|Total|Total of all reporting groups
499795|NCT00726999|B2|Baseline|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
499796|NCT00726999|B1|Baseline|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
499797|NCT00726999|P2|Participant Flow|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
499798|NCT00726999|P1|Participant Flow|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
499799|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
499800|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
499801|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
499802|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
499803|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
499804|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
499805|NCT00726999|E2|Reported Event|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
500895|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
499808|NCT00727025|P1|Participant Flow|All Participants|Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure.
499809|NCT00727025|O2|Outcome|Suture Closure|
499810|NCT00727025|O1|Outcome|Steri-strip Closure|
499811|NCT00727025|O2|Outcome|Wounds Closed With Suture|wound segments closed with traditional suture
499812|NCT00727025|O1|Outcome|Wounds Closed With Device|segment of wounds closed with steri-strip device
499813|NCT00727025|O2|Outcome|Wounds Closed With Suture|wound segments closed with traditional suture
499814|NCT00727025|O1|Outcome|Wounds Closed With Device|segment of wounds closed with steri-strip device
499815|NCT00727025|E2|Reported Event|Wounds Closed With Suture|wound segments closed with traditional suture
499816|NCT00727025|E1|Reported Event|Wounds Closed With Device|segment of wounds closed with steri-strip device
499817|NCT00727064|B3|Baseline|Total|Total of all reporting groups
499818|NCT00727064|B2|Baseline|Sequence Group B|Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling.
499859|NCT00727194|O2|Outcome|Placebo|All patients who received study treatment(s)
499860|NCT00727194|O1|Outcome|Eculizumab|All patients who received study treatment(s)
499819|NCT00727064|B1|Baseline|Sequence Group A|Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling.
499820|NCT00727064|P2|Participant Flow|Sequence Group B|Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling.
499821|NCT00727064|P1|Participant Flow|Sequence Group A|Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling.
499822|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
499823|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
499824|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
499825|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
499826|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
499827|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
499828|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
499829|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
499830|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
499831|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
499832|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
499833|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
499834|NCT00727064|E2|Reported Event|Venlafaxine Extended Release (VEN ER)|SAE or AE reported on VEN ER regardless of which arm or period of trial.
499835|NCT00727064|E1|Reported Event|Desvenlafaxine Succinate Sustained-Release (DVS SR)|SAE or AE reported on DVS SR regardless of which arm or period of trial.
499836|NCT00727090|B3|Baseline|Total|Total of all reporting groups
499837|NCT00727090|B2|Baseline|Usual Medical Care|Usual care by the attending physician staff
499838|NCT00727090|B1|Baseline|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
499839|NCT00727090|P2|Participant Flow|Usual Medical Care|Usual care by the attending physician staff
499840|NCT00727090|P1|Participant Flow|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
499841|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
499842|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
499843|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
499844|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
499845|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
499846|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
499847|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
499848|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
499849|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
499850|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
499851|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
499852|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
499853|NCT00727090|E2|Reported Event|Usual Medical Care|Usual care by the attending physician staff
499854|NCT00727090|E1|Reported Event|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
499902|NCT00727246|B3|Baseline|Control Participants Who Received CDP-Choline|Participants without a history of TBI who were randomized to receive CDP-Choline
499903|NCT00727246|B2|Baseline|Participants With TBI Who Received Placebo|Participants with TBI who were randomized to receive Placebo
499904|NCT00727246|B1|Baseline|Participants With TBI Who Received CDP-Choline|Participants with TBI who were randomized to receive the CDP-Choline
499855|NCT00727194|B1|Baseline|Overall Study|"Eculizumab:
Eculizumab [600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses)].
Period 1: patients received eculizumab for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received placebo for 16 weeks.
Placebo:
Matching placebo [IV weekly (4 doses) followed by IV every other week (7 doses)] Period 1: patients received placebo for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received eculizumab for 16 weeks."
499856|NCT00727194|P3|Participant Flow|Not Randomized/Screen Failures|Not randomized; not treatment cohort
499857|NCT00727194|P2|Participant Flow|Placebo to Eculizumab Sequence|"Placebo: matching placebo IV weekly (4 doses) followed by IV every other week (7 doses).
Eculizumab: eculizumab 600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses).
Period 1: patients received placebo for 16 weeks.
Wash-out period for 5 weeks.
Period 2 (cross-over treatment period): patients received eculizumab for 16 weeks."
499858|NCT00727194|P1|Participant Flow|Eculizumab to Placebo Sequence|"Eculizumab: eculizumab 600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses)
Placebo: matching placebo IV weekly (4 doses) followed by IV every other week (7 doses)
Period 1: patients received eculizumab for 16 weeks.
Wash-out period for 5 weeks.
Period 2 (cross-over treatment period): patients received placebo for 16 weeks."
499863|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499864|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab
eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499865|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499866|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab
eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499867|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499868|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab
eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499869|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499870|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab
eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499871|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499872|NCT00727194|O3|Outcome|Eculizumab Both Periods|"Eculizumab
Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499873|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499874|NCT00727194|O1|Outcome|Eculizumab Period 1|"Eculizumab
Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499875|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499876|NCT00727194|O3|Outcome|Eculizumab Both Periods|"Eculizumab
Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499877|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499878|NCT00727194|O1|Outcome|Eculizumab Period 1|"Eculizumab
Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499879|NCT00727194|O4|Outcome|Placebo Period 2|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499880|NCT00727194|O3|Outcome|Eculizumab Period 2|"eculizumab
eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499881|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499882|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab
eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499883|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499884|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab
eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499885|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499886|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab
eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499887|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
499888|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab
eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
499889|NCT00727194|E2|Reported Event|Eculizumab|"Eculizumab
Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses
Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1."
499890|NCT00727194|E1|Reported Event|Placebo|"Placebo
Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses
Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1."
499891|NCT00727220|B3|Baseline|Total|Total of all reporting groups
499892|NCT00727220|B2|Baseline|Insulin Injections|
499893|NCT00727220|B1|Baseline|Insulin Pump Therapy|
499894|NCT00727220|P2|Participant Flow|Insulin Injections|
499895|NCT00727220|P1|Participant Flow|Insulin Pump Therapy|
499896|NCT00727220|O2|Outcome|Insulin Injections|
499897|NCT00727220|O1|Outcome|Insulin Pump Therapy|
499898|NCT00727220|E2|Reported Event|Insulin Injections|
499899|NCT00727220|E1|Reported Event|Insulin Pump Therapy|
499905|NCT00727246|P4|Participant Flow|Control Participants Who Received Placebo|Individuals without a history of TBI who participated as control subjects and were randomly assigned to receive placebo
499906|NCT00727246|P3|Participant Flow|Control Participants Who Received CDP-Choline|Individuals without a history of TBI who acted as control participants and were randomly assigned to receive CDP-Choline
499907|NCT00727246|P2|Participant Flow|Participants With TBI Who Received Placebo|Participants with a history of TBI who were randomly assigned to the placebo group
499908|NCT00727246|P1|Participant Flow|Participants With TBI Who Received CDP-Choline|Participants who have experienced a TBI and were randomly assigned to receive the study supplement
499909|NCT00727246|O4|Outcome|Control Participants Who Received Placebo|Participants without a history of TBI who were randomized to receive placebo
499910|NCT00727246|O3|Outcome|Control Participants Who Received CDP-Choline|Participants without a history of TBI who were randomized to receive CDP-Choline
499911|NCT00727246|O2|Outcome|Participants With TBI Who Received Placebo|Participants with TBI who were randomized to receive Placebo
499912|NCT00727246|O1|Outcome|Participants With TBI Who Received CDP-Choline|Participants with TBI who were randomized to receive the CDP-Choline
499913|NCT00727246|O4|Outcome|Control Participants Who Received Placebo|Participants without a history of TBI who were randomized to receive placebo
499914|NCT00727246|O3|Outcome|Control Participants Who Received CDP-Choline|Participants without a history of TBI who were randomized to receive CDP-Choline
499915|NCT00727246|O2|Outcome|Participants With TBI Who Received Placebo|Participants with TBI who were randomized to receive Placebo
499916|NCT00727246|O1|Outcome|Participants With TBI Who Received CDP-Choline|Participants with TBI who were randomized to receive the CDP-Choline
499917|NCT00727246|E4|Reported Event|Control Participants Who Received Placebo|Individuals without a history of TBI who participated as control subjects and were randomly assigned to receive placebo
499918|NCT00727246|E3|Reported Event|Control Participants Who Received CDP-Choline|Individuals without a history of TBI who acted as control participants and were randomly assigned to receive CDP-Choline
499919|NCT00727246|E2|Reported Event|Participants With TBI Who Received Placebo|Participants with a history of TBI who were randomly assigned to the placebo group
499920|NCT00727246|E1|Reported Event|Participants With TBI Who Received CDP-Choline|Participants who have experienced a TBI and were randomly assigned to receive the study supplement
499921|NCT00727259|B1|Baseline|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. Results presented concern only participants with all questionnaires returned (940).
499922|NCT00727259|P1|Participant Flow|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
499923|NCT00727259|O2|Outcome|After 3 Months of Treatment|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
499924|NCT00727259|O1|Outcome|After 1 Month of Treatment|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
499925|NCT00727259|E1|Reported Event|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
499926|NCT00727272|B1|Baseline|Entire Study Population|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under Fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
499927|NCT00727272|P3|Participant Flow|Treatment Sequence CAB|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
499928|NCT00727272|P2|Participant Flow|Treatment Sequence BCA|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
499929|NCT00727272|P1|Participant Flow|Treatment Sequence ABC|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
499930|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
499931|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
499932|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
499933|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499934|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg 30 minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
499935|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
499936|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
499937|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499965|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499938|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
499939|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
499940|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
499941|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
499942|NCT00727272|E3|Reported Event|Treatment C - Quinine Sulfate Capsules 324 mg - Fed|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
499943|NCT00727272|E2|Reported Event|Treatment B - Quinine Sulphate Tablets 300 mg - Fasting|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
500340|NCT00734409|E1|Reported Event|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
499944|NCT00727272|E1|Reported Event|Treatment A - Quinine Sulfate Capsules 324 mg - Fasting|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
499945|NCT00727298|B1|Baseline|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
499946|NCT00727298|P1|Participant Flow|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
499947|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
499948|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
499949|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
499950|NCT00727298|E1|Reported Event|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
499951|NCT00727311|B1|Baseline|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
499952|NCT00727311|P1|Participant Flow|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
499953|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
499954|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
499955|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
499956|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.
Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
499957|NCT00727311|E1|Reported Event|All Participants|
499958|NCT00734097|B1|Baseline|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499959|NCT00734097|P1|Participant Flow|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499960|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499961|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499962|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499963|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499964|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
500896|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
499970|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499971|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499972|NCT00734097|E1|Reported Event|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
499973|NCT00734149|B1|Baseline|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
499974|NCT00734149|P1|Participant Flow|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
500002|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500003|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499975|NCT00734149|O2|Outcome|Bortezomib+Melphalan+Prednisone: ASCT|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients proceeded to autologous stem cell transplant (ASCT).
499976|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone: Non-ASCT|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients did not proceed to autologous stem cell transplant (ASCT).
499977|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
499978|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
499979|NCT00734149|E1|Reported Event|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
499980|NCT00734162|B5|Baseline|Total|Total of all reporting groups
499981|NCT00734162|B4|Baseline|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499982|NCT00734162|B3|Baseline|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499983|NCT00734162|B2|Baseline|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499984|NCT00734162|B1|Baseline|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499985|NCT00734162|P4|Participant Flow|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499986|NCT00734162|P3|Participant Flow|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499987|NCT00734162|P2|Participant Flow|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499988|NCT00734162|P1|Participant Flow|TDF 12-14 Years|Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499989|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499990|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499991|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499992|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499993|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499994|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499995|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500256|NCT00734305|E1|Reported Event|All Participatants|Dose Escalation cohort participants + Expansion cohort participants
499996|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499997|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499998|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
499999|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500000|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500001|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500341|NCT00734799|B3|Baseline|Total|Total of all reporting groups
500004|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500005|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500006|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500007|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500008|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500009|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500010|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500011|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500012|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500013|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500014|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500015|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500016|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500017|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500018|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500019|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500020|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500021|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500022|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500023|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500024|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500025|NCT00734162|O2|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500026|NCT00734162|O1|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500027|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500028|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500029|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500030|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500031|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500032|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500033|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500034|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500035|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500036|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500037|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500038|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500039|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500040|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500041|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500042|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500043|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500044|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500045|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500046|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500047|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500048|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500049|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500050|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500051|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500052|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500053|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500054|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500055|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500056|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500057|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500058|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500059|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500060|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500061|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500062|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500063|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500064|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500065|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500066|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500067|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500068|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500069|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500070|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500071|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500072|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500073|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500074|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500075|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500076|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500077|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500078|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500079|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500080|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500081|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500082|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500083|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500084|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500085|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500086|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500087|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500088|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500089|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500090|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500091|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500092|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500093|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500094|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500095|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500096|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500097|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500098|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500099|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500100|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500101|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500102|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500103|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500104|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500105|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500106|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500107|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500108|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500109|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500110|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500111|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500112|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500113|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500114|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500115|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500116|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500117|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500118|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500119|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500120|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500121|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500122|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500123|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500124|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500125|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500126|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500127|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500128|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500129|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500130|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500131|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500132|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500133|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500134|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500135|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500136|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500137|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500138|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500139|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500140|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500141|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500142|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500143|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500144|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500145|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500146|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500147|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500148|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500149|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500150|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500151|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500152|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500153|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500154|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500155|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500156|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500157|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500158|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500159|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500160|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500161|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500162|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500163|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500164|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500165|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500166|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500167|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500168|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500169|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500170|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500171|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500172|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500173|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500174|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500175|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500176|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500177|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500178|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500179|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500180|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500181|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500182|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500183|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500184|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500185|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500186|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500187|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500188|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500189|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500190|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500191|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500192|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500193|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500194|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500195|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500196|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500197|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500198|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500199|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500200|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500201|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500202|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500203|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500204|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500205|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500206|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
500207|NCT00734162|E4|Reported Event|Open-Label Placebo-TDF|Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received placebo during the Randomized Phase of the study and continued to the Open-Label Phase.
500208|NCT00734162|E3|Reported Event|Open-Label TDF-TDF|Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received double-blind TDF during the Randomized Phase of the study and continued to the Open-Label Phase.
500209|NCT00734162|E2|Reported Event|Double-Blind Placebo|Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received placebo during the Randomized Phase of the study.
500210|NCT00734162|E1|Reported Event|Double-Blind TDF|Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received double-blind TDF during the Randomized Phase of the study.
500211|NCT00734214|B3|Baseline|Total|Total of all reporting groups
500212|NCT00734214|B2|Baseline|0.45% NaCl|
500213|NCT00734214|B1|Baseline|0.9% NaCl|
500214|NCT00734214|P2|Participant Flow|0.45% NaCl|
500215|NCT00734214|P1|Participant Flow|0.9% NaCl|
500216|NCT00734214|O2|Outcome|0.45% NaCl|
500217|NCT00734214|O1|Outcome|0.9% NaCl|
500218|NCT00734214|E2|Reported Event|0.45% NaCl|
500219|NCT00734214|E1|Reported Event|0.9% NaCl|
500220|NCT00734305|B3|Baseline|Total|Total of all reporting groups
500221|NCT00734305|B2|Baseline|MM-121 Expansion Cohort|Expansion cohort at recommended phase 2 dose
500222|NCT00734305|B1|Baseline|MM-121 Dose Escalation|MM-121: Dose escalation Frequency - once weekly IV
500223|NCT00734305|P7|Participant Flow|Expansion Cohort|(Highest tested dose in absence of reaching maximum tolerated dose) 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW
500224|NCT00734305|P6|Participant Flow|Dose Escalation: Cohort 6|MM-121: 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW
500225|NCT00734305|P5|Participant Flow|Dose Escalation: Cohort 5|MM-121: 20 mg/kg IV QW
500226|NCT00734305|P4|Participant Flow|Dose Escalation: Cohort 4|MM-121: 15 mg/kg IV QW
500227|NCT00734305|P3|Participant Flow|Dose Escalation: Cohort 3|MM-121: 10 mg/kg IV QW
500228|NCT00734305|P2|Participant Flow|Dose Escalation: Cohort 2|MM-121: 6 mg/kg IV QW
500229|NCT00734305|P1|Participant Flow|Dose Escalation: Cohort 1|MM-121: 3.2 mg/kg IV QW
500230|NCT00734305|O6|Outcome|Recommended Phase 2 Dose|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses Combination of Cohort 6 patients (N=4) and Expansion Cohort Patients (N=18) that received this dose level.
500231|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
500232|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
500233|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
500234|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
500235|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
500236|NCT00734305|O6|Outcome|Recommended Phase 2 Dose|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses Combination of Cohort 6 patients (N=4) and Expansion Cohort Patients (N=18) that received this dose level.
500237|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
500238|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
500239|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
500240|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
500241|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
500242|NCT00734305|O6|Outcome|Cohort 6|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses
500243|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
500244|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
500245|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
500246|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
500247|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
500248|NCT00734305|O1|Outcome|Dose Escalation: All Participants|MM-121: Dose escalation Frequency - once weekly
500249|NCT00734305|O7|Outcome|MM-121 Expansion Cohort|Expansion cohort at recommended phase 2 dose
500250|NCT00734305|O6|Outcome|Dose Escalation: Cohort 6|MM-121 40 mg/kg IV loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV weekly maintenance doses
500251|NCT00734305|O5|Outcome|Dose Escalation: Cohort 5|MM-121 20 mg/kg IV QW
500252|NCT00734305|O4|Outcome|Dose Escalation: Cohort 4|MM-121 15 mg/kg IV QW
500253|NCT00734305|O3|Outcome|Dose Escalation: Cohort 3|MM-121 10 mg/kg IV QW
500254|NCT00734305|O2|Outcome|Dose Escalation: Cohort 2|MM-121 6 mg/kg IV QW
500255|NCT00734305|O1|Outcome|Dose Escalation: Cohort 1|MM-121: 3.2 mg/kg IV QW
500257|NCT00734344|B3|Baseline|Total|Total of all reporting groups
500258|NCT00734344|B2|Baseline|Arm 2|"Efavirenz plus Truvada
Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
500259|NCT00734344|B1|Baseline|Arm 1|"Raltegravir plus Truvada
Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
500260|NCT00734344|P2|Participant Flow|Arm 2|"Efavirenz plus Truvada
Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
500261|NCT00734344|P1|Participant Flow|Arm 1|"Raltegravir plus Truvada
Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
500262|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500263|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500264|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500265|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500342|NCT00734799|B2|Baseline|Intervention|Sleep Intervention for PTSD (SIP)
500266|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500267|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500268|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500269|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500270|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500271|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500272|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500273|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500274|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500275|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500276|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500277|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500278|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500279|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500280|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500281|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500282|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500283|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500284|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500285|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500286|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500287|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500288|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500289|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500290|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500291|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500292|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500293|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500294|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500295|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500296|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500297|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500298|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500299|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500300|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500301|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500343|NCT00734799|B1|Baseline|Wait List|Usual Care/Wait-List Control
500302|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500303|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500304|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500305|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500306|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500307|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500308|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500309|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500310|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500311|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500312|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500313|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500314|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500315|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500316|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500317|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500318|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500319|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500320|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500321|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500322|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500323|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500324|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
500325|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
500326|NCT00734344|E2|Reported Event|Arm 2|"Efavirenz plus Truvada
Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
500327|NCT00734344|E1|Reported Event|Arm 1|"Raltegravir plus Truvada
Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
500328|NCT00734409|B3|Baseline|Total|Total of all reporting groups
500329|NCT00734409|B2|Baseline|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
500330|NCT00734409|B1|Baseline|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
500331|NCT00734409|P2|Participant Flow|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
500332|NCT00734409|P1|Participant Flow|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
500333|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
500334|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
500335|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
500336|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
500337|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
500338|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
500339|NCT00734409|E2|Reported Event|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
500344|NCT00734799|P2|Participant Flow|Intervention|Sleep Intervention for PTSD (SIP)
500348|NCT00734799|O2|Outcome|Intervention|Sleep Intervention for PTSD (SIP)
500349|NCT00734799|O1|Outcome|Wait List|Usual Care/Wait-List Control
500350|NCT00734799|E2|Reported Event|Intervention|Sleep Intervention for PTSD (SIP)
500351|NCT00734799|E1|Reported Event|Wait List|Usual Care/Wait-List Control
500352|NCT00734851|B1|Baseline|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
500353|NCT00734851|P1|Participant Flow|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
500354|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
500355|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
500356|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
500357|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
500358|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
500359|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
500360|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
500361|NCT00734851|E1|Reported Event|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
500362|NCT00734929|B3|Baseline|Total|Total of all reporting groups
500363|NCT00734929|B2|Baseline|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500364|NCT00734929|B1|Baseline|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500365|NCT00734929|P2|Participant Flow|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500366|NCT00734929|P1|Participant Flow|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500367|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500368|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500369|NCT00734929|O2|Outcome|Ondansetron + Dexamethasone|"Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Ondansetron + Dexamethasone: Ondansetron 4 mg + Dexamethasone 10 mg"
500370|NCT00734929|O1|Outcome|Aprepitant + Dexamethasone|"Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
Aprepitant + Dexamethasone: Aprepitant 40 mg + Dexamethasone 10 mg"
500371|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500372|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500373|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500374|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500375|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500376|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500377|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500378|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500379|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500380|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500381|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500382|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500383|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500384|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500385|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500386|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500387|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500388|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500389|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
500390|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500391|NCT00734929|E2|Reported Event|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
572700|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
500392|NCT00734929|E1|Reported Event|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
500393|NCT00734968|B3|Baseline|Total|Total of all reporting groups
500394|NCT00734968|B2|Baseline|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)
Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
500395|NCT00734968|B1|Baseline|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
500396|NCT00734968|P2|Participant Flow|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
500397|NCT00734968|P1|Participant Flow|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO twice a day (BID) x 3 days post-operatively. The incidence of urinary tract infection (UTI) in this group will be compared with group one (1).
Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100 mg tablets."
500398|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)
Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
500399|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
500400|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)
Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
500401|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
500402|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)
Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
500403|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
500404|NCT00734968|E2|Reported Event|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
500405|NCT00734968|E1|Reported Event|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)
Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
500406|NCT00734994|B1|Baseline|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
500407|NCT00734994|P1|Participant Flow|Mitomycin C With Hyperthermia and Recurrent Bladder Cancer|Mitomycin C with Hyperthermia to Treat Recurrent Bladder Cancer
500408|NCT00734994|O1|Outcome|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
500409|NCT00734994|O1|Outcome|Hyperthermia System, Mitomycin C|"Pilot study single arm study to test the safety, tolerability and clinical benefit of regional hyperthermia and mitomycin-C intravesical chemotherapy to treat non-invasive Transitional Cell carcinoma (TCC) of the bladder that has recurred after standard resection and adjuvant therapy.
Hyperthermia System: Hyperthermia applied to heat the bladder to a temperature of 42 degrees Celsius for 40-60 minutes concurrent with mitomycin Treatment Schedule: 6 Weekly Sessions (Induction) followed by 4 Monthly Sessions (Maintenance) until documented second recurrence
Mitomycin C: 40 mg in 40 ml sterile water instilled into bladder"
503832|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
500411|NCT00735007|B1|Baseline|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500412|NCT00735007|P1|Participant Flow|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500413|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500414|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500415|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500416|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500417|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500418|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500419|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500420|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500421|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500422|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500423|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500424|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500425|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500426|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500427|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500428|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500429|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500430|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500431|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500432|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500433|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500434|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500435|NCT00735007|E1|Reported Event|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
500436|NCT00735072|B3|Baseline|Total|Total of all reporting groups
500437|NCT00735072|B2|Baseline|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
500438|NCT00735072|B1|Baseline|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
500439|NCT00735072|P2|Participant Flow|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
500440|NCT00735072|P1|Participant Flow|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
500441|NCT00735072|O2|Outcome|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
500442|NCT00735072|O1|Outcome|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
500443|NCT00735072|E2|Reported Event|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
500444|NCT00735072|E1|Reported Event|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
500445|NCT00735306|B1|Baseline|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
500446|NCT00735306|P1|Participant Flow|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
500447|NCT00735306|O1|Outcome|Single Arm Avastin, Tarceva and Radiation Therapy|"Avastin, Tarceva and Radiation Therapy
Avastin: Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy
Tarceva: Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy
Radiation Therapy: Radiation to the pancreas Monday through Friday for 28 treatments"
500448|NCT00735306|O1|Outcome|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
500449|NCT00735306|O1|Outcome|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
500450|NCT00735306|E1|Reported Event|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
500453|NCT00735371|B3|Baseline|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500454|NCT00735371|B2|Baseline|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500455|NCT00735371|B1|Baseline|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500456|NCT00735371|P4|Participant Flow|Placebo|Placebo
500457|NCT00735371|P3|Participant Flow|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500458|NCT00735371|P2|Participant Flow|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500459|NCT00735371|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500460|NCT00735371|O4|Outcome|Placebo|Placebo
500461|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
572701|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
500462|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500463|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500464|NCT00735371|O4|Outcome|Placebo|Placebo
500465|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500466|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500467|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500468|NCT00735371|O4|Outcome|Placebo|Placebo
500469|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500470|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500471|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500472|NCT00735371|E4|Reported Event|Placebo|Placebo
500473|NCT00735371|E3|Reported Event|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500474|NCT00735371|E2|Reported Event|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500475|NCT00735371|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
500476|NCT00735397|B1|Baseline|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
500477|NCT00735397|P1|Participant Flow|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
500478|NCT00735397|O3|Outcome|Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
500479|NCT00735397|O2|Outcome|Complex Partial Plus Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
500480|NCT00735397|O1|Outcome|Overall|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
500481|NCT00735397|O3|Outcome|Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
500520|NCT00735462|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
500482|NCT00735397|O2|Outcome|Complex Partial Plus Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
500483|NCT00735397|O1|Outcome|Overall|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
500484|NCT00735397|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
500485|NCT00735397|E1|Reported Event|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
500486|NCT00735436|B1|Baseline|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
500487|NCT00735436|P1|Participant Flow|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an enzyme-inducing anti-epileptic drugs (EIAED), the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
500488|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
500489|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
500535|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
500490|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the UGT 1A1 polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an EIAED, the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
500491|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the UGT 1A1 polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an EIAED, the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
500492|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
500493|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
500494|NCT00735436|E1|Reported Event|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
500495|NCT00735449|B3|Baseline|Total|Total of all reporting groups
500496|NCT00735449|B2|Baseline|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
500497|NCT00735449|B1|Baseline|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
500498|NCT00735449|P2|Participant Flow|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
500499|NCT00735449|P1|Participant Flow|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
500500|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
500501|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
500502|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
500503|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
500504|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
500505|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
500506|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
500507|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
500508|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
500509|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
500510|NCT00735449|E2|Reported Event|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
500511|NCT00735449|E1|Reported Event|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
500512|NCT00735462|B4|Baseline|Total|Total of all reporting groups
500513|NCT00735462|B3|Baseline|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
500514|NCT00735462|B2|Baseline|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
500515|NCT00735462|B1|Baseline|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
500516|NCT00735462|P3|Participant Flow|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
500517|NCT00735462|P2|Participant Flow|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
500518|NCT00735462|P1|Participant Flow|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
500519|NCT00735462|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
500521|NCT00735462|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
500522|NCT00735462|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
500523|NCT00735462|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
500524|NCT00735462|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
500525|NCT00735462|E3|Reported Event|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
500526|NCT00735462|E2|Reported Event|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
500527|NCT00735462|E1|Reported Event|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
500528|NCT00735475|B3|Baseline|Total|Total of all reporting groups
500529|NCT00735475|B2|Baseline|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
500530|NCT00735475|B1|Baseline|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
500531|NCT00735475|P2|Participant Flow|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
500532|NCT00735475|P1|Participant Flow|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
500533|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
500534|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
500536|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
500537|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
500538|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
500539|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
500540|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
500541|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
500542|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
500543|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
500544|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
500545|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
500546|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
500547|NCT00735475|E2|Reported Event|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
500548|NCT00735475|E1|Reported Event|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
500549|NCT00735553|B4|Baseline|Total|Total of all reporting groups
500550|NCT00735553|B3|Baseline|Placebo|"oral daily dose of placebo
Placebo: Two placebo capsules orally daily for up to four months"
500551|NCT00735553|B2|Baseline|50 mg Proellex|"50 mg oral daily dose of Proellex
Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
500552|NCT00735553|B1|Baseline|25 mg Proellex|"25 mg oral daily dose of Proellex
Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
500553|NCT00735553|P1|Participant Flow|All Groups|25 mg, 50 mg oral daily dose of Proellex or placebo
500554|NCT00735553|O3|Outcome|Placebo|"oral daily dose of placebo
Placebo: Two placebo capsules orally daily for up to four months"
500555|NCT00735553|O2|Outcome|50 mg Proellex|"50 mg oral daily dose of Proellex
Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
500556|NCT00735553|O1|Outcome|25 mg Proellex|"25 mg oral daily dose of Proellex
Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
500557|NCT00735553|E3|Reported Event|Placebo|"oral daily dose of placebo
Placebo: Two placebo capsules orally daily for up to four months"
500558|NCT00735553|E2|Reported Event|50 mg Proellex|"50 mg oral daily dose of Proellex
Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
500559|NCT00735553|E1|Reported Event|25 mg Proellex|"25 mg oral daily dose of Proellex
Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
500560|NCT00735618|B1|Baseline|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
500561|NCT00735618|P1|Participant Flow|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
500562|NCT00735618|O1|Outcome|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program and summed ESAS scores
500563|NCT00735618|E1|Reported Event|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
500564|NCT00735644|B6|Baseline|Total|Total of all reporting groups
500565|NCT00735644|B5|Baseline|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
500566|NCT00735644|B4|Baseline|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
500567|NCT00735644|B3|Baseline|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
500610|NCT00735670|B3|Baseline|Total|Total of all reporting groups
500568|NCT00735644|B2|Baseline|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
500569|NCT00735644|B1|Baseline|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
500570|NCT00735644|P5|Participant Flow|Hepatitis A|Participants 12 to 18 months of age received the Hepatitis A vaccine
500571|NCT00735644|P4|Participant Flow|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
500572|NCT00735644|P3|Participant Flow|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3
500573|NCT00735644|P2|Participant Flow|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
500574|NCT00735644|P1|Participant Flow|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.
500575|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
500576|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
500577|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
500578|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
500579|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
500580|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
500581|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
500582|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
500583|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
500584|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
500585|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received the Hepatitis vaccine intramuscularly
500586|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE CV from Acambis at WRAIR subcutaneously
500587|NCT00735644|O3|Outcome|JE-CV MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 3 subcutaneously
500588|NCT00735644|O2|Outcome|JE-CV MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 2 subcutaneously
500589|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
500590|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
500591|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
500592|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
500593|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
500594|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
500595|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
500596|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
500597|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
500598|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
500599|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
500600|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
500601|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
500602|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
500603|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
500604|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
500605|NCT00735644|E5|Reported Event|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
500606|NCT00735644|E4|Reported Event|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
500607|NCT00735644|E3|Reported Event|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
500608|NCT00735644|E2|Reported Event|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
500609|NCT00735644|E1|Reported Event|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
500611|NCT00735670|B2|Baseline|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
500612|NCT00735670|B1|Baseline|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
500613|NCT00735670|P2|Participant Flow|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
500614|NCT00735670|P1|Participant Flow|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
500615|NCT00735670|O2|Outcome|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
500653|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500616|NCT00735670|O1|Outcome|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
500617|NCT00735670|O2|Outcome|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
500618|NCT00735670|O1|Outcome|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
500619|NCT00735670|E2|Reported Event|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
500620|NCT00735670|E1|Reported Event|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
500621|NCT00735696|B1|Baseline|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks."
500622|NCT00735696|P1|Participant Flow|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
500623|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
500624|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
500625|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
500626|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
500654|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500655|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500656|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500627|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
500628|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
500629|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
500630|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
500631|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
500632|NCT00735696|E1|Reported Event|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.
paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.
carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.
Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
500633|NCT00735709|B5|Baseline|Total|Total of all reporting groups
500634|NCT00735709|B4|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500635|NCT00735709|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500636|NCT00735709|B2|Baseline|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500637|NCT00735709|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500638|NCT00735709|P4|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500639|NCT00735709|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500640|NCT00735709|P2|Participant Flow|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500641|NCT00735709|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500642|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500643|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500644|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500645|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500646|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500647|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500648|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500649|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500650|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500651|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500652|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500848|NCT00736073|B3|Baseline|Total|Total of all reporting groups
500657|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500658|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500659|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500660|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500661|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500662|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500663|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500664|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500665|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500666|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500667|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500668|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500669|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500670|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500671|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500672|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500673|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500674|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500675|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500676|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500677|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500678|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500679|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500680|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500681|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500682|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500683|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500684|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500685|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500686|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500687|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500688|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500689|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500690|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500691|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500692|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500693|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500694|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500695|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500696|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500697|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500698|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500699|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500700|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500701|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500702|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500703|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500704|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500705|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500706|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500707|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500708|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500709|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500710|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500711|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500712|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500713|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500714|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500715|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500716|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500717|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500718|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500719|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500720|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500721|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500722|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500723|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500724|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500725|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500726|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500727|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500728|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500729|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500730|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500731|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500732|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500733|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500734|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500735|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500736|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500737|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500738|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500739|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500740|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500741|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500742|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500743|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500744|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500745|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500746|NCT00735709|E4|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500747|NCT00735709|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500897|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500748|NCT00735709|E2|Reported Event|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
500749|NCT00735709|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
500750|NCT00735787|B3|Baseline|Total|Total of all reporting groups
500751|NCT00735787|B2|Baseline|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500752|NCT00735787|B1|Baseline|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500753|NCT00735787|P2|Participant Flow|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500754|NCT00735787|P1|Participant Flow|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500755|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500756|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500917|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500757|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500758|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500759|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500760|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500761|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500762|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500763|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500764|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500765|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500766|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500767|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500768|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500769|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500770|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500771|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500772|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500773|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500774|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500775|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500776|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500777|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500778|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500898|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500779|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500780|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500781|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500782|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500783|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500784|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500785|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500918|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500919|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500786|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500787|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500788|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500789|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500790|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500791|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500792|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500793|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500794|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500795|NCT00735787|E2|Reported Event|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
500796|NCT00735787|E1|Reported Event|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
500797|NCT00735839|B3|Baseline|Total|Total of all reporting groups
500798|NCT00735839|B2|Baseline|Placebo|Placebo single dose on Day 1
500799|NCT00735839|B1|Baseline|V710|V710 vaccination (60 mcg) single dose on Day 1
500800|NCT00735839|P2|Participant Flow|Placebo|Placebo single dose on Day 1
500801|NCT00735839|P1|Participant Flow|V710|V710 vaccination (60 mcg) single dose on Day 1
500802|NCT00735839|O2|Outcome|Placebo|Placebo single dose on Day 1
500803|NCT00735839|O1|Outcome|V710|V710 vaccination (60 mcg) single dose on Day 1
500804|NCT00735839|O2|Outcome|Placebo|Placebo single dose on Day 1
500805|NCT00735839|O1|Outcome|V710|V710 vaccination (60 mcg) single dose on Day 1
500806|NCT00735839|E2|Reported Event|Placebo|Placebo single dose on Day 1
500807|NCT00735839|E1|Reported Event|V710|V710 vaccination (60 mcg) single dose on Day 1
500808|NCT00735904|B1|Baseline|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
500809|NCT00735904|P1|Participant Flow|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
500810|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
500841|NCT00735969|P1|Participant Flow|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and assigned to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
500811|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
500812|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
500813|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
500920|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500814|NCT00735904|E1|Reported Event|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
500815|NCT00735917|B1|Baseline|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
500816|NCT00735917|P1|Participant Flow|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
500817|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
500818|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
500819|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
500820|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
500821|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
500822|NCT00735917|E1|Reported Event|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
500823|NCT00735943|B1|Baseline|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500824|NCT00735943|P1|Participant Flow|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500825|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500826|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500827|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500828|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500829|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500830|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500831|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500832|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500833|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500834|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500835|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500836|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500837|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500838|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500839|NCT00735943|E1|Reported Event|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
500840|NCT00735969|B1|Baseline|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
500894|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500842|NCT00735969|O1|Outcome|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
500843|NCT00735969|E1|Reported Event|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
500844|NCT00736034|B1|Baseline|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
500845|NCT00736034|P1|Participant Flow|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
500846|NCT00736034|O1|Outcome|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
500847|NCT00736034|E1|Reported Event|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
500849|NCT00736073|B2|Baseline|Arm 2-Randomized to Placebo|"Placebo
Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500850|NCT00736073|B1|Baseline|Arm 1-medication Pre and Post Procedure|"aprepitant
aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500851|NCT00736073|P2|Participant Flow|Arm 2-Randomized to Placebo|"Placebo
Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500852|NCT00736073|P1|Participant Flow|Arm 1-medication Pre and Post Procedure|"Aprepitant
aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500853|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo
Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500854|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"Aprepitant
aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500855|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo
Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500856|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"Aprepitant
aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500857|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo
Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500858|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"aprepitant
aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500859|NCT00736073|E2|Reported Event|Arm 2-Randomized to Placebo|"Placebo
Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500860|NCT00736073|E1|Reported Event|Arm 1-medication Pre and Post Procedure|"aprepitant
aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
500861|NCT00736099|B3|Baseline|Total|Total of all reporting groups
500862|NCT00736099|B2|Baseline|New Lina|Patients pre-treated with placebo
500863|NCT00736099|B1|Baseline|Old Lina|Patients pre-treated with linagliptin
500864|NCT00736099|P2|Participant Flow|New Lina|Patients pre-treated with placebo
500865|NCT00736099|P1|Participant Flow|Old Lina|Patients pre-treated with linagliptin (BI 1356)
500866|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500867|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500868|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500869|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500870|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500871|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500872|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500873|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500874|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500875|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500876|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500877|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500878|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500879|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500880|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500881|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500882|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500883|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500884|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500885|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500886|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500887|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500888|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500889|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500890|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500891|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500892|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500893|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500899|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500900|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500901|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500902|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500903|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500904|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500905|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500906|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500907|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500908|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500909|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500910|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500911|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500912|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500913|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500914|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500915|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500916|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500921|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500922|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500923|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500924|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500925|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500926|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500927|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500928|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500929|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500930|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500931|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500932|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500933|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500934|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500935|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500936|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500937|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500938|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500939|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500940|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500941|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500942|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500943|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500944|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500945|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500946|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500947|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500948|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500949|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500950|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500951|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500952|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500953|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500954|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500955|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500956|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
500957|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
500958|NCT00736099|E2|Reported Event|New Lina|Patients pre-treated with placebo
500959|NCT00736099|E1|Reported Event|Old Lina|Patients pre-treated with linagliptin
500960|NCT00736125|B3|Baseline|Total|Total of all reporting groups
500961|NCT00736125|B2|Baseline|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
500962|NCT00736125|B1|Baseline|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
500963|NCT00736125|P2|Participant Flow|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
500964|NCT00736125|P1|Participant Flow|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
500965|NCT00736125|O2|Outcome|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
500966|NCT00736125|O1|Outcome|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
500967|NCT00736125|O2|Outcome|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
500968|NCT00736125|O1|Outcome|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
503833|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
500969|NCT00736125|E2|Reported Event|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
500970|NCT00736125|E1|Reported Event|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
500971|NCT00736190|B1|Baseline|A: TDF|Tenofovir disoproxil fumarate 300 mg by mouth daily
500972|NCT00736190|P1|Participant Flow|A: TDF|Tenofovir disoproxil fumarate (TDF) 300 mg by mouth daily
500973|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
500974|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
500975|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
500976|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
500977|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
500978|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
500979|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
500980|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
500981|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
500982|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
500983|NCT00736190|E1|Reported Event|A: TDF|Tenofovir disoproxil fumarate 300 mg by mouth daily
500984|NCT00736229|B4|Baseline|Total|Total of all reporting groups
572702|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
500985|NCT00736229|B3|Baseline|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
500986|NCT00736229|B2|Baseline|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
500987|NCT00736229|B1|Baseline|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
500988|NCT00736229|P3|Participant Flow|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
500989|NCT00736229|P2|Participant Flow|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
500990|NCT00736229|P1|Participant Flow|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
500991|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
500992|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
500993|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
500994|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
500995|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
500996|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
500997|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
501023|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
501024|NCT00736255|E2|Reported Event|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
500998|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
500999|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in acute coronary syndrome (ACS) patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, all patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
501000|NCT00736229|O1|Outcome|Exenatide|Patients with admission blood glucose values of 140-400 mg/dL admitted to the coronary intensive care unit were eligible. Patients that provided consent were intravenously infused with Exenatide as a 0.05 mcg/min bolus for 30 minutes followed by a fixed 0.025 mcg/min dose for up to 48 hours. Blood glucose values were measured hourly following commencement of infusion.
501001|NCT00736229|E1|Reported Event|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
501036|NCT00736385|B2|Baseline|Placebo|"Placebo capsule
Placebo: placebo 2000 mg daily for 12 months"
501002|NCT00736242|B1|Baseline|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
501003|NCT00736242|P1|Participant Flow|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus ribavirin (RBV) according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
501004|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
501005|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
501006|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
501007|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
501008|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
501009|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
501010|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
501011|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
501012|NCT00736242|E1|Reported Event|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
501013|NCT00736255|B3|Baseline|Total|Total of all reporting groups
501014|NCT00736255|B2|Baseline|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
501015|NCT00736255|B1|Baseline|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
501016|NCT00736255|P2|Participant Flow|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
501017|NCT00736255|P1|Participant Flow|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
501018|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
501019|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
501020|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
501021|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
501022|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
501066|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
501025|NCT00736255|E1|Reported Event|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
501026|NCT00736333|B1|Baseline|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
501027|NCT00736333|P1|Participant Flow|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
501028|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
501029|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
501030|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
501031|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
501032|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
501033|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
501034|NCT00736333|E1|Reported Event|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
501035|NCT00736385|B3|Baseline|Total|Total of all reporting groups
572703|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
501037|NCT00736385|B1|Baseline|Metformin|"Metformin XR 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
501038|NCT00736385|P2|Participant Flow|Placebo|"Placebo capsule
Placebo: placebo 2000 mg daily for 12 months"
501039|NCT00736385|P1|Participant Flow|Metformin|"Metformin XR (extended-release) 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
501040|NCT00736385|O2|Outcome|Placebo|"Placebo capsule
Placebo: placebo 2000 mg daily for 12 months"
501041|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
501042|NCT00736385|O2|Outcome|Placebo|"Placebo capsule
Placebo: placebo 2000 mg daily for 12 months"
501043|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
501044|NCT00736385|O2|Outcome|Placebo|"Placebo capsule
Placebo: placebo 2000 mg daily for 12 months"
501045|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
501046|NCT00736385|O2|Outcome|Placebo|"Placebo capsule
Placebo: placebo 2000 mg daily for 12 months"
501047|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
501048|NCT00736385|E2|Reported Event|Placebo|"Placebo capsule
Placebo: placebo 2000 mg daily for 12 months"
501049|NCT00736385|E1|Reported Event|Metformin|"Metformin XR 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
501050|NCT00736476|B3|Baseline|Total|Total of all reporting groups
501051|NCT00736476|B2|Baseline|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months
501052|NCT00736476|B1|Baseline|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months.
501053|NCT00736476|P2|Participant Flow|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months,followed by H.pylori challenge (oral administration of infectious HP inoculum)1 month later.
501054|NCT00736476|P1|Participant Flow|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months, followed by H.pylori challenge(oral administration of infectious HP inoculum)1 month later.
501055|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
501056|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
501057|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
501058|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
501059|NCT00736476|O4|Outcome|Group II (Placebo) Non-Infected|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
501060|NCT00736476|O3|Outcome|Group II (Placebo) Infected|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
501061|NCT00736476|O2|Outcome|Group I (HP Vaccine) Non-Infected|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
501062|NCT00736476|O1|Outcome|Group I (HP Vaccine) Infected|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
501063|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
501064|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
501065|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
501067|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
501068|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
501069|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
501070|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
501071|NCT00736476|E2|Reported Event|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months
501072|NCT00736476|E1|Reported Event|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months.
501073|NCT00736489|B1|Baseline|Baseline Total|Total number of patients randomized and treated in the study
501074|NCT00736489|P6|Participant Flow|PEBCDAa|Placebo followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg.
501075|NCT00736489|P5|Participant Flow|EDABCPa|Formoterol 36 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Placebo.
501144|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501076|NCT00736489|P4|Participant Flow|DCPABEa|Formoterol 9 Mcg followed by AZD3199 1920 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg.
501077|NCT00736489|P3|Participant Flow|CBEPADa|AZD3199 1920 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg .
501078|NCT00736489|P2|Participant Flow|BADEPCa|AZD3199 480 Mcg followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 1920 Mcg.
501079|NCT00736489|P1|Participant Flow|APCDEBa|AZD3199 120 Mcg followed by Placebo followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg.
501080|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501081|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501082|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501083|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501084|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501085|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501086|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501087|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501088|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501089|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501090|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501091|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501092|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501093|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501094|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501095|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501096|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501097|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501098|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501099|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501100|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501101|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501102|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501103|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501104|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501105|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501106|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501107|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501108|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501109|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501110|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501111|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501112|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501113|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501114|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501115|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501116|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501117|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501118|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501119|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501120|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501121|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501122|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501123|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501124|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501125|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501126|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501127|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501128|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501129|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501130|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501131|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501132|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501133|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501134|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501135|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501136|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501137|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501138|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501139|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501140|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501141|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501142|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501143|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501145|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501146|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501147|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501148|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501149|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501150|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501151|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501152|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501153|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501154|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501155|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501156|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501157|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501158|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501159|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501160|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501161|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501162|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501163|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501164|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501165|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501166|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501167|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501168|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501169|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501170|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501171|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501172|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501173|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501174|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501175|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501176|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501177|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501178|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501179|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501180|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501181|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501182|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501183|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501184|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501185|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501186|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501187|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501188|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501189|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501190|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501191|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501192|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501193|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501194|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501195|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501196|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501197|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501198|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501199|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501200|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501201|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501202|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501203|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501204|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501205|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501206|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501207|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501208|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501209|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501210|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501211|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501212|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501213|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501214|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501215|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501216|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501217|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501218|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
501219|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501220|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501221|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501222|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501223|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501224|NCT00736489|E6|Reported Event|Placebo|Placebo inhaled via Turbuhaler
501225|NCT00736489|E5|Reported Event|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
501226|NCT00736489|E4|Reported Event|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
501227|NCT00736489|E3|Reported Event|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
501228|NCT00736489|E2|Reported Event|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
501229|NCT00736489|E1|Reported Event|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
501230|NCT00736502|B1|Baseline|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
501231|NCT00736502|P1|Participant Flow|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
501232|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
501233|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
501234|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
501235|NCT00736502|E1|Reported Event|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
501236|NCT00736580|B3|Baseline|Total|Total of all reporting groups
501237|NCT00736580|B2|Baseline|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
501238|NCT00736580|B1|Baseline|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
501239|NCT00736580|P2|Participant Flow|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
501240|NCT00736580|P1|Participant Flow|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
501241|NCT00736580|O2|Outcome|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
501242|NCT00736580|O1|Outcome|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
501243|NCT00736580|E2|Reported Event|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
501244|NCT00736580|E1|Reported Event|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
501245|NCT00736723|B3|Baseline|Total|Total of all reporting groups
501246|NCT00736723|B2|Baseline|Postoperative/Posttraumatic Patients With Septic Shock|Postoperative/posttraumatic critically ill patients with septic shock
501247|NCT00736723|B1|Baseline|Postoperative/Posttraumatic Patients With Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
501248|NCT00736723|P2|Participant Flow|Patients With Septic Shock|critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing septic shock
501249|NCT00736723|P1|Participant Flow|Patients With Non-septic Shock|critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing non-septic shock
501250|NCT00736723|O2|Outcome|Patients Septic Shock|Postoperative/posttraumatic critically ill patients with septic shock
501251|NCT00736723|O1|Outcome|Patients Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
501252|NCT00736723|E2|Reported Event|Postoperative/Posttraumatic Patients With Septi|Postoperative/posttraumatic critically ill patients with septic shock
501253|NCT00736723|E1|Reported Event|Postoperative/Posttraumatic Patients With Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
501254|NCT00736840|B1|Baseline|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
501311|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501839|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
501255|NCT00736840|P1|Participant Flow|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
501256|NCT00736840|O1|Outcome|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
501257|NCT00736840|O1|Outcome|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
501258|NCT00736840|E1|Reported Event|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
501320|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501505|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
501259|NCT00736853|B1|Baseline|Entire Study Population|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets) during the open-label period. Participants received placebo or fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg (same dose which was used in second week of open-label period) in double-blind period.
501260|NCT00736853|P3|Participant Flow|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501261|NCT00736853|P2|Participant Flow|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501262|NCT00736853|P1|Participant Flow|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501263|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501264|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501265|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501266|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501267|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501268|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501269|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501270|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501271|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501272|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501273|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501274|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501275|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501276|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501277|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501278|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501279|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501312|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501280|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501281|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501282|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501283|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501284|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501285|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501503|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501286|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501287|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501288|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501289|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501290|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501291|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501292|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501293|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501294|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501295|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501296|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501297|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501298|NCT00736853|E3|Reported Event|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
501299|NCT00736853|E2|Reported Event|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
501300|NCT00736853|E1|Reported Event|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
501301|NCT00736879|B5|Baseline|Total|Total of all reporting groups
501302|NCT00736879|B4|Baseline|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501303|NCT00736879|B3|Baseline|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501304|NCT00736879|B2|Baseline|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501305|NCT00736879|B1|Baseline|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501306|NCT00736879|P4|Participant Flow|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501307|NCT00736879|P3|Participant Flow|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501308|NCT00736879|P2|Participant Flow|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501309|NCT00736879|P1|Participant Flow|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501310|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
503834|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
501313|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501314|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501315|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501316|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501317|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501318|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501319|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
502564|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
501321|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501322|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501323|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501324|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501325|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501326|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501327|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501328|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501329|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501330|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501331|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501332|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501333|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501334|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501335|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501336|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501337|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501338|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501339|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501340|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501341|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501342|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501343|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501344|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501345|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501346|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501347|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501348|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501840|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501349|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501350|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501351|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501352|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501353|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501354|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501355|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501356|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501357|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501358|NCT00736879|E4|Reported Event|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501359|NCT00736879|E3|Reported Event|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501360|NCT00736879|E2|Reported Event|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501361|NCT00736879|E1|Reported Event|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
501362|NCT00736944|B1|Baseline|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501363|NCT00736944|P1|Participant Flow|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501364|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501365|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501366|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501367|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501368|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501369|NCT00736944|O3|Outcome|FDG-PET/CT|
501370|NCT00736944|O2|Outcome|CT Scan|
501371|NCT00736944|O1|Outcome|Clinical Examination|
501372|NCT00736944|O3|Outcome|FDG-PET/CT|
501373|NCT00736944|O2|Outcome|CT Scan|
501374|NCT00736944|O1|Outcome|Clinical Examination|
501375|NCT00736944|O3|Outcome|FDG-PET/CT|
501376|NCT00736944|O2|Outcome|CT Scan|
501377|NCT00736944|O1|Outcome|Clinical Examination|
501392|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
501378|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501379|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501380|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501381|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501382|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501383|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501384|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501385|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501386|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501387|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501388|NCT00736944|E1|Reported Event|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
501389|NCT00736957|B1|Baseline|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
501390|NCT00736957|P1|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
501391|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
501490|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
503835|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
501393|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
501394|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
501395|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
502565|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
501396|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
501397|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
501398|NCT00736957|E1|Reported Event|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
501399|NCT00736996|B4|Baseline|Total|Total of all reporting groups
501400|NCT00736996|B3|Baseline|Placebo|Placebo: Matching oral tablet daily for 6 months
501401|NCT00736996|B2|Baseline|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
501402|NCT00736996|B1|Baseline|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
501403|NCT00736996|P3|Participant Flow|Placebo|Placebo: Matching oral tablet daily for 6 months
501404|NCT00736996|P2|Participant Flow|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
501405|NCT00736996|P1|Participant Flow|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
501406|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
501407|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
501408|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
501409|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
501410|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
501411|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
501412|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
501413|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
501414|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
501415|NCT00736996|E3|Reported Event|Placebo|Placebo: Matching oral tablet daily for 6 months
501416|NCT00736996|E2|Reported Event|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
501417|NCT00736996|E1|Reported Event|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
501418|NCT00737048|B4|Baseline|Total|Total of all reporting groups
501419|NCT00737048|B3|Baseline|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501420|NCT00737048|B2|Baseline|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501491|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
503836|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
501421|NCT00737048|B1|Baseline|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501422|NCT00737048|P3|Participant Flow|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501423|NCT00737048|P2|Participant Flow|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501504|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501424|NCT00737048|P1|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501425|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501426|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501427|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501428|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501429|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501430|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501431|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501432|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501433|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501434|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501435|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501436|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501437|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501492|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
503837|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
501438|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501439|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501440|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501441|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501442|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501443|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501444|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501445|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501446|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501447|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501448|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501449|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501450|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501451|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501452|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501453|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501454|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501493|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
503838|NCT00746733|O2|Outcome|Adderall XR|
501455|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501456|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501457|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501458|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501459|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501460|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501461|NCT00737048|E3|Reported Event|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501462|NCT00737048|E2|Reported Event|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501463|NCT00737048|E1|Reported Event|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
501464|NCT00737061|B1|Baseline|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501465|NCT00737061|P1|Participant Flow|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501466|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501467|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501468|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501469|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501470|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501471|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501472|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501473|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501474|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501475|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501476|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501477|NCT00737061|E1|Reported Event|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
501478|NCT00737100|B4|Baseline|Total|Total of all reporting groups
501479|NCT00737100|B3|Baseline|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501480|NCT00737100|B2|Baseline|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501481|NCT00737100|B1|Baseline|Placebo|Patients randomised to receive matching placebo
501482|NCT00737100|P3|Participant Flow|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501483|NCT00737100|P2|Participant Flow|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501484|NCT00737100|P1|Participant Flow|Placebo|Patients randomised to receive matching placebo
501485|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501486|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501487|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
501488|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501489|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
503839|NCT00746733|O1|Outcome|Vyvanse|
501494|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501495|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501496|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
501497|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501498|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501499|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
501500|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501501|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501502|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
501506|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501507|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501508|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
501509|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501510|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501511|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
501512|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501513|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501514|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
501515|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501516|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501517|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
501518|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501519|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501520|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
501521|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501522|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501523|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
501524|NCT00737100|E3|Reported Event|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
501525|NCT00737100|E2|Reported Event|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
501526|NCT00737100|E1|Reported Event|Placebo|Patients randomised to receive matching placebo
501527|NCT00737178|B3|Baseline|Total|Total of all reporting groups
501528|NCT00737178|B2|Baseline|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
501529|NCT00737178|B1|Baseline|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
501530|NCT00737178|P2|Participant Flow|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
501531|NCT00737178|P1|Participant Flow|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
501532|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
501533|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
501534|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
501535|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
501536|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
501537|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
501538|NCT00737178|E2|Reported Event|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
501539|NCT00737178|E1|Reported Event|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
501540|NCT00737204|B3|Baseline|Total|Total of all reporting groups
501541|NCT00737204|B2|Baseline|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
501542|NCT00737204|B1|Baseline|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
501543|NCT00737204|P2|Participant Flow|Placebo|Participants will receive a placebo pill (matching the active medication) for 4 weeks, then a 16-week course of armodafinil. Starting dose of is one placebo pill/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 5 placebo pills/day.
501544|NCT00737204|P1|Participant Flow|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. Starting dose of armodafinil is 50 mg/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 250 mg/day.
501545|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
501546|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
501547|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
501548|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
501549|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
501550|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
501551|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
501552|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
501553|NCT00737204|E2|Reported Event|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
501554|NCT00737204|E1|Reported Event|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
501555|NCT00737243|B1|Baseline|Patients With Tumor Assays Performed|Of 289 patients initially enrolled, 252 had successful assays performed. 37 patients had insufficient tissue for assay and came off study.
501556|NCT00737243|P1|Participant Flow|All Patients With a Successful Tumor Assays Performed|Subjects in this group had a successful molecular assay of biopsy tissue
501557|NCT00737243|O1|Outcome|Patients With Successful Tumor Assays Performed|In 252 participants successful assays were performed. In 29 participants the amount of tumour and/or viable RNA present in the biopsy specimen was inadequate.
501558|NCT00737243|O2|Outcome|Less Treatment Responsive|Patients who received assay-directed therapy for tumors with a predicted median survival ≤ 12 months
501559|NCT00737243|O1|Outcome|More Treatment Responsive|Patients who received assay-directed therapy for tumor types with a predicted median survival ≥ 12 months.
501560|NCT00737243|E1|Reported Event|All Treated Patients|
501561|NCT00730236|B1|Baseline|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501562|NCT00730236|P1|Participant Flow|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501563|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501564|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501565|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501566|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501567|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501568|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501569|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501570|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501571|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501572|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501573|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501574|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501688|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501575|NCT00730236|E1|Reported Event|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
501576|NCT00730275|B5|Baseline|Total|Total of all reporting groups
501577|NCT00730275|B4|Baseline|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
501578|NCT00730275|B3|Baseline|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
501579|NCT00730275|B2|Baseline|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
501580|NCT00730275|B1|Baseline|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
501581|NCT00730275|P4|Participant Flow|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
501582|NCT00730275|P3|Participant Flow|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
501583|NCT00730275|P2|Participant Flow|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
501584|NCT00730275|P1|Participant Flow|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
501585|NCT00730275|O4|Outcome|Placebo|Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
501586|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
501587|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
501588|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
501589|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
501590|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
501591|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
501592|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
501593|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
501594|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
501595|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
501596|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
501597|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
501598|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
501599|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
501600|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
501601|NCT00730275|O4|Outcome|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
501602|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
501603|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
501604|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
501605|NCT00730275|E4|Reported Event|Placebo|Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
501606|NCT00730275|E3|Reported Event|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
501607|NCT00730275|E2|Reported Event|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
501608|NCT00730275|E1|Reported Event|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
501609|NCT00730327|B3|Baseline|Total|Total of all reporting groups
501610|NCT00730327|B2|Baseline|Control|"Control arm receives the Behavioral modification intervention only.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501611|NCT00730327|B1|Baseline|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501612|NCT00730327|P2|Participant Flow|Control|"Control arm receives the Behavioral modification intervention only.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501613|NCT00730327|P1|Participant Flow|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501614|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501615|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501616|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501617|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501618|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501619|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501620|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501621|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501622|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501623|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501893|NCT00731042|E1|Reported Event|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
501624|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501625|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501626|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501627|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501628|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501629|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501630|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501631|NCT00730327|E2|Reported Event|Control|Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
501632|NCT00730327|E1|Reported Event|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
501633|NCT00730353|B1|Baseline|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
501634|NCT00730353|P1|Participant Flow|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
501635|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
501636|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
501637|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
501689|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501754|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501638|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
501639|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
501692|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501640|NCT00730353|E1|Reported Event|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
501641|NCT00730483|B1|Baseline|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
501642|NCT00730483|P1|Participant Flow|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
501643|NCT00730483|O1|Outcome|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
501644|NCT00730483|O1|Outcome|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
501645|NCT00730483|O1|Outcome|Single Arm|PVA microporous hydrospheres/doxorubicin hydrochloride
501646|NCT00730483|O1|Outcome|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
501647|NCT00730483|O1|Outcome|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
501648|NCT00730483|E1|Reported Event|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
501649|NCT00730639|B6|Baseline|Total|Total of all reporting groups
501650|NCT00730639|B5|Baseline|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501651|NCT00730639|B4|Baseline|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501652|NCT00730639|B3|Baseline|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501653|NCT00730639|B2|Baseline|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501654|NCT00730639|B1|Baseline|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501655|NCT00730639|P5|Participant Flow|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
501714|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501715|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501836|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501656|NCT00730639|P4|Participant Flow|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
501657|NCT00730639|P3|Participant Flow|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
501658|NCT00730639|P2|Participant Flow|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
501659|NCT00730639|P1|Participant Flow|0.1 mg/kg Nivolumab|0.1 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg)was administered intravenously (IV) every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, partial response (PR), or stable disease (SD), who subsequently experienced confirmed PD.
501660|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501661|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501662|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501663|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501664|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501665|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501666|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501667|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501668|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501669|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501670|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501671|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501672|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501673|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501674|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501675|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501676|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501677|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501678|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501679|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501680|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501681|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501682|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501683|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501684|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501685|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501686|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501687|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
501837|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
501690|NCT00730639|O6|Outcome|All Dose Groups|All participants receiving Intravenous (IV) solution of 0.1-10 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501691|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501761|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501693|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501694|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501695|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501696|NCT00730639|O6|Outcome|All Dose Groups|All participants receiving Intravenous (IV) solution of 0.1-10 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501697|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501698|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501699|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501700|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501701|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
501702|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501703|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501704|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501705|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501706|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501707|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501708|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501709|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501710|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501711|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501712|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501713|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501716|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501717|NCT00730639|E5|Reported Event|10 mg/kg Nivolumab|IV solution of 10 milligrams nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501718|NCT00730639|E4|Reported Event|3 mg/kg Nivolumab|IV solution of 3 milligrams nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501719|NCT00730639|E3|Reported Event|1 mg/kg Nivolumab|IV solution of 1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501720|NCT00730639|E2|Reported Event|0.3 mg/kg Nivolumab|IV solution of 0.3 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501762|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
572704|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
501721|NCT00730639|E1|Reported Event|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
501722|NCT00730691|B6|Baseline|Total|Total of all reporting groups
501723|NCT00730691|B5|Baseline|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501724|NCT00730691|B4|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501725|NCT00730691|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501726|NCT00730691|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501727|NCT00730691|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501728|NCT00730691|P5|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501729|NCT00730691|P4|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501730|NCT00730691|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501731|NCT00730691|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501732|NCT00730691|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501733|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501734|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501735|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501736|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501737|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501738|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501739|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501740|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501741|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501742|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501743|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501744|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501745|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501746|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501747|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501748|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501749|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501750|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501751|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501752|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501753|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
503840|NCT00746733|E4|Reported Event|Adderall XR + Prilosec OTC|
501755|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501756|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501757|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501758|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501759|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501760|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501763|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501764|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501765|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501766|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501767|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501768|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501769|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501770|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501771|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501772|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501773|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501774|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501775|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501776|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501777|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501778|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501779|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501780|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501781|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501782|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501783|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501784|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501785|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501786|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501787|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501788|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501789|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501790|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501791|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501792|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501793|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501838|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501794|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501795|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501796|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501797|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501798|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501799|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501800|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
502151|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
501801|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501802|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501803|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501804|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501805|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501806|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501807|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501808|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501809|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501810|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501811|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501812|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501813|NCT00730691|E5|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
501814|NCT00730691|E4|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501815|NCT00730691|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
501816|NCT00730691|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
501817|NCT00730691|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
501818|NCT00730730|B1|Baseline|Iliac Stenting|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
501819|NCT00730730|P1|Participant Flow|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
501820|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
501821|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
501822|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
501823|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
501824|NCT00730730|E1|Reported Event|Iliac Stenting|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
501825|NCT00730756|B3|Baseline|Total|Total of all reporting groups
501826|NCT00730756|B2|Baseline|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501827|NCT00730756|B1|Baseline|Placebo|Vehicle placebo nasal spray once daily
501828|NCT00730756|P2|Participant Flow|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501829|NCT00730756|P1|Participant Flow|Placebo|Vehicle placebo nasal spray once daily
501830|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501831|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
501832|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501833|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
501834|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501835|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
501841|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
501842|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501843|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
501844|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501845|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
501846|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501847|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
501848|NCT00730756|E2|Reported Event|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
501849|NCT00730756|E1|Reported Event|Placebo|Vehicle placebo nasal spray once daily
501850|NCT00730847|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
502152|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
501851|NCT00730847|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
501852|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
501853|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
501854|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
501855|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
501856|NCT00730847|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
501857|NCT00730912|B4|Baseline|Total|Total of all reporting groups
501858|NCT00730912|B3|Baseline|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
501859|NCT00730912|B2|Baseline|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
501860|NCT00730912|B1|Baseline|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
501861|NCT00730912|P3|Participant Flow|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
501862|NCT00730912|P2|Participant Flow|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
501863|NCT00730912|P1|Participant Flow|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
501864|NCT00730912|O3|Outcome|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
501865|NCT00730912|O2|Outcome|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
501866|NCT00730912|O1|Outcome|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
501867|NCT00730912|O3|Outcome|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
501868|NCT00730912|O2|Outcome|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
501869|NCT00730912|O1|Outcome|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
501870|NCT00730912|E3|Reported Event|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
501871|NCT00730912|E2|Reported Event|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
501872|NCT00730912|E1|Reported Event|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
501873|NCT00730925|B1|Baseline|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
501874|NCT00730925|P1|Participant Flow|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
501875|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
501876|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
501877|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
501878|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
501879|NCT00730925|E1|Reported Event|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
501880|NCT00730964|B1|Baseline|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
501881|NCT00730964|P1|Participant Flow|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
501882|NCT00730964|O1|Outcome|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
501883|NCT00730964|O1|Outcome|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product.
501884|NCT00730964|E1|Reported Event|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
501885|NCT00731042|B3|Baseline|Total|Total of all reporting groups
502012|NCT00731120|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
501886|NCT00731042|B2|Baseline|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
501887|NCT00731042|B1|Baseline|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
501888|NCT00731042|P2|Participant Flow|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
501889|NCT00731042|P1|Participant Flow|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
501890|NCT00731042|O2|Outcome|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
501891|NCT00731042|O1|Outcome|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
501892|NCT00731042|E2|Reported Event|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
501894|NCT00731055|B1|Baseline|Study Participants|Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.
501895|NCT00731055|P1|Participant Flow|Study Participants|This is a within-group study design, all participant who completed the study receive all 4 experimental treatments
501896|NCT00731055|O4|Outcome|Varenicline 2.0 mg|The outcome of the session during which participant received varenicline 2.0 mg
501897|NCT00731055|O3|Outcome|Varenicline 1.0 mg|The outcome of the session during which participant received varenicline 1.0 mg
501898|NCT00731055|O2|Outcome|Varenicline 0.5 mg|The outcome of the session during which participant received varenicline 0.5 mg
501899|NCT00731055|O1|Outcome|Placebo|The outcome of the session during which participant received placebo
501900|NCT00731055|E1|Reported Event|Study Participants|Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.
501901|NCT00731094|B3|Baseline|Total|Total of all reporting groups
501902|NCT00731094|B2|Baseline|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501903|NCT00731094|B1|Baseline|Physcial Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501904|NCT00731094|P2|Participant Flow|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501905|NCT00731094|P1|Participant Flow|Physcial Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501906|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501907|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501908|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501909|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501910|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501911|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501912|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501913|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
502013|NCT00731120|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
501914|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501915|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501916|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
502031|NCT00731211|O1|Outcome|Pazopanib|"800 mg of pazopanib orally each day continuously
Pazopanib: 800 mg of pazopanib orally each day continuously"
502153|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
501917|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501918|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501919|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501920|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501921|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501922|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501923|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501924|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501925|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501926|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501927|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501928|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501929|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501930|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501931|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501932|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
502014|NCT00731133|B1|Baseline|Disulfiram|Disulfiram at 250 mg daily
502015|NCT00731133|P1|Participant Flow|Disulfiram|Disulfiram at 250 mg daily
501933|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501934|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
502032|NCT00731211|E1|Reported Event|Pazopanib|"800 mg of pazopanib orally each day continuously
Pazopanib: 800 mg of pazopanib orally each day continuously"
502566|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
501935|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501936|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501937|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501938|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501939|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501940|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501941|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501942|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501943|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501944|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501945|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501946|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501947|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501948|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501949|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501950|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
502016|NCT00731133|O1|Outcome|Disulfiram 250 mg|
502017|NCT00731133|O1|Outcome|Disulfiram 250 mg|
502018|NCT00731133|E1|Reported Event|Disulfiram|Disulfiram at 250 mg daily
502019|NCT00731198|B3|Baseline|Total|Total of all reporting groups
502020|NCT00731198|B2|Baseline|Active Comparator|Hyoscine-N-butylbromide
501951|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501952|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501953|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501954|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501955|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501956|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501957|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501958|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501959|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501960|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501961|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501962|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501963|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501964|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501965|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501966|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501967|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501968|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
502021|NCT00731198|B1|Baseline|Experimental|Drotaverine hydrochloride
502022|NCT00731198|P2|Participant Flow|Active Comparator|Hyoscine-N-butylbromide
502023|NCT00731198|P1|Participant Flow|Experimental|Drotaverine hydrochloride
502024|NCT00731198|O2|Outcome|Active Comparator|Hyoscine-N-butylbromide
502025|NCT00731198|O1|Outcome|Experimental|Drotaverine hydrochloride
501969|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501970|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501971|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501972|NCT00731094|E2|Reported Event|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
501973|NCT00731094|E1|Reported Event|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
501974|NCT00731120|B4|Baseline|Total|Total of all reporting groups
501975|NCT00731120|B3|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
501976|NCT00731120|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
501977|NCT00731120|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
501978|NCT00731120|P3|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
501979|NCT00731120|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
501980|NCT00731120|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
501981|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
501982|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
501983|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
501984|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
501985|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
501986|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
501987|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
501988|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
501989|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
501990|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
501991|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
501992|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
501993|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
501994|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
501995|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
501996|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
501997|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
501998|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
501999|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
502000|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
502001|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
502002|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
502003|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
502004|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
502005|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
502006|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
502007|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
502008|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
502009|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
502010|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
502011|NCT00731120|E3|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
503841|NCT00746733|E3|Reported Event|Vyvanse + Prilosec OTC|
502026|NCT00731198|E2|Reported Event|Active Comparator|Hyoscine-N-butylbromide
502027|NCT00731198|E1|Reported Event|Experimental|Drotaverine hydrochloride
502028|NCT00731211|B1|Baseline|Pazopanib|"800 mg of pazopanib orally each day continuously
Pazopanib: 800 mg of pazopanib orally each day continuously"
502029|NCT00731211|P1|Participant Flow|Pazopanib|"800 mg of pazopanib orally each day continuously
Pazopanib: 800 mg of pazopanib orally each day continuously"
502030|NCT00731211|O1|Outcome|Pazopanib|"800 mg of pazopanib orally each day continuously
Pazopanib: 800 mg of pazopanib orally each day continuously"
502684|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502033|NCT00731341|B1|Baseline|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
502034|NCT00731341|P1|Participant Flow|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
502035|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
502036|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
502037|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
502038|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
502039|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
502040|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
502041|NCT00731341|E1|Reported Event|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
502042|NCT00731484|B1|Baseline|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
502043|NCT00731484|P1|Participant Flow|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
502044|NCT00731484|O1|Outcome|General Population|Subjects were recruited from patients presenting for a routine visit at the physician office study sites
502045|NCT00731484|E1|Reported Event|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
502046|NCT00731549|B1|Baseline|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502047|NCT00731549|P1|Participant Flow|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502048|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502049|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502050|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502051|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502052|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502053|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
503842|NCT00746733|E2|Reported Event|Adderall XR|
502054|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502055|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502148|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502056|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502057|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502058|NCT00731549|E1|Reported Event|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
502059|NCT00737282|B3|Baseline|Total|Total of all reporting groups
502060|NCT00737282|B2|Baseline|Proellex 50 mg|"Proellex 50 mg once daily
Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
502061|NCT00737282|B1|Baseline|25 mg Proellex|"Proellex 25 mg once daily
Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
502062|NCT00737282|P1|Participant Flow|Proellex|"Proellex 25 or 50 mg once daily
One capsule Proellex 25 mg or 50 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
502063|NCT00737282|O2|Outcome|Proellex 50 mg|"Proellex 50 mg once daily
Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
502064|NCT00737282|O1|Outcome|25 mg Proellex|"Proellex 25 mg once daily
Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
502065|NCT00737282|E2|Reported Event|Proellex 50 mg|"Proellex 50 mg once daily
Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
502066|NCT00737282|E1|Reported Event|25 mg Proellex|"Proellex 25 mg once daily
Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
502067|NCT00737360|B1|Baseline|TAS-106|
502068|NCT00737360|P1|Participant Flow|TAS-106|
502069|NCT00737360|O1|Outcome|TAS-106|
502070|NCT00737360|O1|Outcome|TAS-106|
502071|NCT00737360|O1|Outcome|TAS-106|
502072|NCT00737360|O1|Outcome|TAS-106|
502073|NCT00737360|E1|Reported Event|TAS-106|
502074|NCT00737438|B1|Baseline|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
502075|NCT00737438|P1|Participant Flow|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
502076|NCT00737438|O1|Outcome|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
502077|NCT00737438|E1|Reported Event|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
502078|NCT00737464|B1|Baseline|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502079|NCT00737464|P1|Participant Flow|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502080|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502081|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502082|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502083|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502084|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502085|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502086|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502139|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502087|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502088|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502089|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502090|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502091|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502092|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502093|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502094|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502095|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502096|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502097|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502098|NCT00737464|E1|Reported Event|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
502099|NCT00737477|B1|Baseline|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502100|NCT00737477|P1|Participant Flow|Mircera in Chronic Kidney Disease (CKD)-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the dose adaptation period (DAP) to maintain target hemoglobin (Hb) concentrations within 10 to 12 grams per deciliter (g/dL). Treatment continued during a designated efficacy evaluation period (EEP) from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502101|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502102|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502103|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502104|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502105|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502140|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502141|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502106|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502149|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502150|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502107|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502108|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502109|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502110|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502111|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502112|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502113|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502114|NCT00737477|E1|Reported Event|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
502115|NCT00737529|B1|Baseline|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal
502116|NCT00737529|P1|Participant Flow|Lenalidomide|"Single agent lenalidomide
Lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal."
502117|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
502142|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502143|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
503843|NCT00746733|E1|Reported Event|Vyvanse|
502118|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
572705|NCT00923260|E2|Reported Event|Roux-en-Y Gastric Bypass Alone|
502119|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
502120|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
502121|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
502122|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
502123|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
502124|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
502125|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
502126|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
502127|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
502128|NCT00737529|E1|Reported Event|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal
502129|NCT00737568|B3|Baseline|Total|Total of all reporting groups
502130|NCT00737568|B2|Baseline|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502131|NCT00737568|B1|Baseline|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502132|NCT00737568|P2|Participant Flow|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502133|NCT00737568|P1|Participant Flow|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet once daily plus emtricitabine (FTC)/TDF placebo tablet once daily
502134|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502135|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502136|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502137|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502138|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
503844|NCT00746785|B4|Baseline|Total|Total of all reporting groups
502144|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502145|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502146|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502147|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502154|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502155|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502156|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502157|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502158|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502159|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502160|NCT00737568|E2|Reported Event|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
502161|NCT00737568|E1|Reported Event|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
502162|NCT00737594|B4|Baseline|Total|Total of all reporting groups
502163|NCT00737594|B3|Baseline|18 mcg TID|"Cobiprostone 54 mcg
Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
502164|NCT00737594|B2|Baseline|12 mcg TID|"Cobiprostone 36 mcg
Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
502165|NCT00737594|B1|Baseline|Placebo|Placebo: 0 mcg capsules three times daily (TID)
502166|NCT00737594|P3|Participant Flow|18 mcg TID|"Cobiprostone 54 mcg
Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
502167|NCT00737594|P2|Participant Flow|12 mcg TID|"Cobiprostone 36 mcg
Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
502168|NCT00737594|P1|Participant Flow|Placebo|Placebo: 0 mcg capsules three times daily (TID)
502169|NCT00737594|O3|Outcome|18 mcg TID|"Cobiprostone 54 mcg
Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
502170|NCT00737594|O2|Outcome|12 mcg TID|"Cobiprostone 36 mcg
Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
502171|NCT00737594|O1|Outcome|Placebo|Placebo: 0 mcg capsules three times daily (TID)
502172|NCT00737594|E3|Reported Event|18 mcg TID|"Cobiprostone 54 mcg
Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
502173|NCT00737594|E2|Reported Event|12 mcg TID|"Cobiprostone 36 mcg
Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
502174|NCT00737594|E1|Reported Event|Placebo|Placebo: 0 mcg capsules three times daily (TID)
502175|NCT00740714|B4|Baseline|Total|Total of all reporting groups
502176|NCT00740714|B3|Baseline|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502177|NCT00740714|B2|Baseline|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502178|NCT00740714|B1|Baseline|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502179|NCT00740714|P3|Participant Flow|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502180|NCT00740714|P2|Participant Flow|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502181|NCT00740714|P1|Participant Flow|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502182|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502183|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502184|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502185|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502186|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502187|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502188|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502189|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502190|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502191|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502192|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502193|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502194|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502195|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
503845|NCT00746785|B3|Baseline|C - Placebo|placebo : placebo
502196|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502197|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502198|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502199|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502200|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502201|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502202|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502203|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502204|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502205|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502206|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502207|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502208|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502209|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502210|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502211|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502212|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502213|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502214|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502215|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502216|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502217|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502218|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502219|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502220|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502221|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502222|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502223|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502224|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502225|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502226|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502227|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502228|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502229|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502230|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502231|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502232|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502233|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502234|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502235|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502236|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502237|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502238|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502239|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502240|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502241|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
503854|NCT00746785|E3|Reported Event|C - Placebo|placebo : placebo
502242|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502243|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502244|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502245|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502246|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502247|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502248|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502249|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502250|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502251|NCT00740714|E3|Reported Event|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
502252|NCT00740714|E2|Reported Event|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
502253|NCT00740714|E1|Reported Event|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
502254|NCT00740727|B1|Baseline|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
502255|NCT00740727|P1|Participant Flow|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
502256|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
502257|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
502258|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
502259|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
502260|NCT00740779|B4|Baseline|Total|Total of all reporting groups
502261|NCT00740779|B3|Baseline|Placebo|1 placebo capsule daily
502262|NCT00740779|B2|Baseline|Silodosin 8 mg|Silodosin 8 mg daily
502263|NCT00740779|B1|Baseline|Silodosin 4 mg|Silodosin 4 mg daily
502264|NCT00740779|P3|Participant Flow|Placebo|1 placebo capsule daily
502265|NCT00740779|P2|Participant Flow|Silodosin 8 mg|Silodosin 8 mg daily
502266|NCT00740779|P1|Participant Flow|Silodosin 4 mg|Silodosin 4 mg daily
502267|NCT00740779|O3|Outcome|Placebo|1 placebo capsule daily
502268|NCT00740779|O2|Outcome|Silodosin 8 mg|Silodosin 8 mg daily
502269|NCT00740779|O1|Outcome|Silodosin 4 mg|Silodosin 4 mg daily
502270|NCT00740779|E3|Reported Event|Placebo|1 placebo capsule daily
502271|NCT00740779|E2|Reported Event|Silodosin 8 mg|Silodosin 8 mg daily
502272|NCT00740779|E1|Reported Event|Silodosin 4 mg|Silodosin 4 mg daily
502273|NCT00740792|B5|Baseline|Total|Total of all reporting groups
502274|NCT00740792|B4|Baseline|Placebo|placebo control
502275|NCT00740792|B3|Baseline|Fluticasone Propionate|active comparator of fluticasone propionate
502276|NCT00740792|B2|Baseline|Azelastine HCL|active comparator of azelastine HCl
502277|NCT00740792|B1|Baseline|MP29-02|azelastine HCl/fluticasone propionate
502278|NCT00740792|P4|Participant Flow|Placebo|placebo control
502279|NCT00740792|P3|Participant Flow|Fluticasone Propionate|active comparator of fluticasone propionate
502280|NCT00740792|P2|Participant Flow|Azelastine HCL|active comparator of azelastine HCl
502281|NCT00740792|P1|Participant Flow|MP29-02|azelastine HCl/fluticasone propionate
502282|NCT00740792|O4|Outcome|Placebo|placebo control
502283|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
502284|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
502285|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
502286|NCT00740792|O4|Outcome|Placebo|placebo control
502287|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
502288|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
502289|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
502290|NCT00740792|O4|Outcome|Placebo|placebo control
502291|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
502292|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
502293|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
502294|NCT00740792|E4|Reported Event|Placebo|placebo control
502295|NCT00740792|E3|Reported Event|Fluticasone Propionate|active comparator of fluticasone propionate
502296|NCT00740792|E2|Reported Event|Azelastine HCL|active comparator of azelastine HCl
502297|NCT00740792|E1|Reported Event|MP29-02|azelastine HCl/fluticasone propionate
502298|NCT00740831|B4|Baseline|Total|Total of all reporting groups
502299|NCT00740831|B3|Baseline|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
502300|NCT00740831|B2|Baseline|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502301|NCT00740831|B1|Baseline|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502302|NCT00740831|P3|Participant Flow|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
503846|NCT00746785|B2|Baseline|B - 5 mg Olanzapine|"5 mg Olanzapine
olanzapine : 5 mg"
502303|NCT00740831|P2|Participant Flow|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502304|NCT00740831|P1|Participant Flow|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502305|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
502306|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502307|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502308|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
502309|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502310|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502311|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
502312|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502313|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502314|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
502315|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502316|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502317|NCT00740831|E3|Reported Event|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
502318|NCT00740831|E2|Reported Event|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502319|NCT00740831|E1|Reported Event|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
502320|NCT00740857|B4|Baseline|Total|Total of all reporting groups
502321|NCT00740857|B3|Baseline|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
502322|NCT00740857|B2|Baseline|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
502323|NCT00740857|B1|Baseline|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
502324|NCT00740857|P3|Participant Flow|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
502325|NCT00740857|P2|Participant Flow|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
502326|NCT00740857|P1|Participant Flow|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
502327|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
502328|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
502329|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
502330|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
502331|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
502332|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
502333|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
502334|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
502335|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
502336|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
502337|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
502338|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
502339|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
502340|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
502341|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
502342|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
502343|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
502344|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
502345|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
502346|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
502347|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
502348|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
502349|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
502350|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
502351|NCT00740857|E3|Reported Event|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
502352|NCT00740857|E2|Reported Event|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
502353|NCT00740857|E1|Reported Event|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
502354|NCT00740870|B1|Baseline|Enrolled Cohort|All subjects enrolled
502355|NCT00740870|P1|Participant Flow|Enrolled|All subjects enrolled (n=171)
502356|NCT00740870|O1|Outcome|Implanted >24 Hour Cohort|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
502357|NCT00740870|O1|Outcome|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
502358|NCT00740870|O1|Outcome|Implanted >24 Hour Cohort|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
502359|NCT00740870|O1|Outcome|Implanted >24 Hour Cohort|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
502360|NCT00740870|O1|Outcome|Implanted >24 Hour Cohort|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
502361|NCT00740870|O1|Outcome|Implanted Cohort|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
572706|NCT00923260|E1|Reported Event|Roux-en-Y Gastric Bypass/Omentectomy|
502362|NCT00740870|O1|Outcome|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
502363|NCT00740870|O1|Outcome|Attempted Implant Cohort|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).
502364|NCT00740870|O1|Outcome|Implanted >24 Hour Cohort|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
502365|NCT00740870|E1|Reported Event|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
502366|NCT00741013|B4|Baseline|Total|Total of all reporting groups
502367|NCT00741013|B3|Baseline|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
502368|NCT00741013|B2|Baseline|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
502369|NCT00741013|B1|Baseline|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
502370|NCT00741013|P3|Participant Flow|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
502371|NCT00741013|P2|Participant Flow|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
502372|NCT00741013|P1|Participant Flow|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
502373|NCT00741013|O3|Outcome|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
502374|NCT00741013|O2|Outcome|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
502375|NCT00741013|O1|Outcome|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
502376|NCT00741013|O3|Outcome|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
502377|NCT00741013|O2|Outcome|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
502378|NCT00741013|O1|Outcome|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
502379|NCT00741013|E3|Reported Event|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
502380|NCT00741013|E2|Reported Event|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
502381|NCT00741013|E1|Reported Event|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
502382|NCT00741026|B1|Baseline|Placebo / Olanzapine|"Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights.
OR
Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days."
502383|NCT00741026|P1|Participant Flow|Placebo / Olanzapine|"Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights.
OR
Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days.
Randomization information not available."
502384|NCT00741026|O2|Outcome|Olanzapine|
502385|NCT00741026|O1|Outcome|Placebo|
502386|NCT00741026|O2|Outcome|Olanzapine|
502387|NCT00741026|O1|Outcome|Placebo|
502388|NCT00741026|O2|Outcome|Olanzapine|
502389|NCT00741026|O1|Outcome|Placebo|
502390|NCT00741026|O2|Outcome|Olanzapine|
502391|NCT00741026|O1|Outcome|Placebo|
502392|NCT00741026|O2|Outcome|Olanzapine|
502393|NCT00741026|O1|Outcome|Placebo|
502394|NCT00741026|O2|Outcome|Olanzapine|
502395|NCT00741026|O1|Outcome|Placebo|
502396|NCT00741026|O2|Outcome|Olanzapine|
502397|NCT00741026|O1|Outcome|Placebo|
502398|NCT00741026|O2|Outcome|Olanzapine|
502399|NCT00741026|O1|Outcome|Placebo|
502400|NCT00741026|O2|Outcome|Olanzapine|
502401|NCT00741026|O1|Outcome|Placebo|
502402|NCT00741026|O2|Outcome|Olanzapine|
502403|NCT00741026|O1|Outcome|Placebo|
502404|NCT00741026|O2|Outcome|Olanzapine|
502405|NCT00741026|O1|Outcome|Placebo|
502406|NCT00741026|O2|Outcome|Olanzapine|
502407|NCT00741026|O1|Outcome|Placebo|
502408|NCT00741026|E2|Reported Event|Olanzapine|
502409|NCT00741026|E1|Reported Event|Placebo|Placebo : (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
502410|NCT00741039|B3|Baseline|Total|Total of all reporting groups
502411|NCT00741039|B2|Baseline|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
502412|NCT00741039|B1|Baseline|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
502413|NCT00741039|P2|Participant Flow|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
502414|NCT00741039|P1|Participant Flow|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
502415|NCT00741039|O2|Outcome|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
502416|NCT00741039|O1|Outcome|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
502417|NCT00741039|E2|Reported Event|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
502418|NCT00741039|E1|Reported Event|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
502419|NCT00741091|B1|Baseline|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
502420|NCT00741091|P1|Participant Flow|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
502421|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
502422|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
502423|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
502424|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
502425|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
502426|NCT00741091|E1|Reported Event|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
502427|NCT00741104|B1|Baseline|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
502428|NCT00741104|P1|Participant Flow|RA Patients|Patients on maintenance therapy for rheumatoid arthritis (RA) with infliximab for >= the past 12 months.
502429|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
502430|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
502431|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
502432|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
502433|NCT00741104|E1|Reported Event|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
502434|NCT00741156|B1|Baseline|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
502435|NCT00741156|P1|Participant Flow|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
502436|NCT00741156|O6|Outcome|Cerebral Resistance After Enalaprilat|cerebral resistance is measured after enalaprilat
502437|NCT00741156|O5|Outcome|Cerebral Resistance at Baseline|cerebral resistance is measured in baseline condition
502438|NCT00741156|O4|Outcome|Pulmonary Resistance After Enalaprilat|pulmonary resistance is measured after enalaprilat
502439|NCT00741156|O3|Outcome|Pulmonary Resistance at Baseline|pulmonary resistance at baseline is measured
502440|NCT00741156|O2|Outcome|Systemic Resistance After Enalaprilat|systemic resistance is measured after enalaprilat
502441|NCT00741156|O1|Outcome|Systemic Resistance at Baseline|systemic resistance in baseline condition
502442|NCT00741156|O6|Outcome|Cerebral Blood Flow After Enalaprilat|Cerebral blood flow 20 minutes after enalaprilat
502443|NCT00741156|O5|Outcome|Cerebral Blood Flow Baseline|Cerebral blood flow at baseline
502444|NCT00741156|O4|Outcome|Pulmonary Blood Flow After Enaliprilat|Pulmonary blood flow 20 minutes after enalaprilat
502445|NCT00741156|O3|Outcome|Pulmonary Blood Flow Baseline|Pulmonary blood flow baseline condition
502446|NCT00741156|O2|Outcome|Systemic Blood Flow After Enalaprilat|Systemic blood flow 20 minutes after enalaprilat
502447|NCT00741156|O1|Outcome|Systemic Blood Flow Baseline|Systemic blood flow in baseline condition
502448|NCT00741156|E1|Reported Event|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
502449|NCT00741273|B3|Baseline|Total|Total of all reporting groups
502450|NCT00741273|B2|Baseline|Mpaired|Hepatically impaired females
502451|NCT00741273|B1|Baseline|Healthy|Healthy females
502452|NCT00741273|P2|Participant Flow|Impaired|Proellex single dose each of 25 mg and 50 mg in hepatically impaired females
502453|NCT00741273|P1|Participant Flow|Healthy|Proellex single dose each of 25 mg and 50 mg in healthy females
502454|NCT00741273|O4|Outcome|50 mg Impaired|"Proellex 50 mg in impaired females
Proellex: Proellex 50 mg capsule, single dose"
502455|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females
Proellex: Proellex 50 mg capsule, single dose"
503847|NCT00746785|B1|Baseline|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine
olanzapine : 2.5 mg"
502456|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 25 mg in hepatically impaired females
Proellex: Proellex 25 mg capsule, single dose"
502457|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females
Proellex: Proellex 25 mg capsule, single dose"
502458|NCT00741273|O4|Outcome|50 mg Impaired|"Proellex 50 mg in impaired females
Proellex: Proellex 50 mg capsule, single dose"
502459|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females
Proellex: Proellex 50 mg capsule, single dose"
502460|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 25 mg in hepatically impaired females
Proellex: Proellex 25 mg capsule, single dose"
502461|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females
Proellex: Proellex 25 mg capsule, single dose"
502462|NCT00741273|O4|Outcome|Proellex 50 mg Impaired|"Proellex 50 mg in impaired females
Proellex: Proellex 50 mg capsule, single dose"
502463|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females
Proellex: Proellex 50 mg capsule, single dose"
502464|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 50 mg in hepatically impaired females
Proellex: Proellex 25 mg capsule, single dose"
502465|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females
Proellex: Proellex 25 mg capsule, single dose"
502466|NCT00741273|E2|Reported Event|Proellex Impaired|"Proellex 25 mg and 50 mg in hepatically impaired females
Proellex: Proellex 25 mg and 50 mg capsule, single dose each"
502467|NCT00741273|E1|Reported Event|Proellex Healthy|"Proellex 25 mg and 50 mg in healthy females
Proellex: Proellex 25 mg and 50 mg capsule, single dose each"
502468|NCT00741286|B3|Baseline|Total|Total of all reporting groups
502469|NCT00741286|B2|Baseline|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
502470|NCT00741286|B1|Baseline|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
502471|NCT00741286|P2|Participant Flow|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
502472|NCT00741286|P1|Participant Flow|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
502473|NCT00741286|O2|Outcome|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
502474|NCT00741286|O1|Outcome|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
502475|NCT00741286|O2|Outcome|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
502476|NCT00741286|O1|Outcome|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
502477|NCT00741286|E2|Reported Event|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
502478|NCT00741286|E1|Reported Event|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
502479|NCT00741338|B3|Baseline|Total|Total of all reporting groups
502480|NCT00741338|B2|Baseline|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
502481|NCT00741338|B1|Baseline|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
502482|NCT00741338|P2|Participant Flow|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
502483|NCT00741338|P1|Participant Flow|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
502484|NCT00741338|O2|Outcome|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
502496|NCT00741390|O3|Outcome|ACC/28G - BD/33G|Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
502497|NCT00741390|O2|Outcome|OTU/28G - BD/33G|OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
502498|NCT00741390|O1|Outcome|OTM/28G - BD/33G|OneTouch Mini Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
503848|NCT00746785|P3|Participant Flow|C - Placebo|placebo : placebo
502485|NCT00741338|O1|Outcome|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
502504|NCT00741390|O4|Outcome|OTU/28G|"OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet
See description for BD/33G."
502505|NCT00741390|O3|Outcome|OTM/28G|"OneTouch Mini Device / OneTouch UltraSoft 28G Lancet
See description for BD/33G."
502506|NCT00741390|O2|Outcome|OTM/33G|"OneTouch Mini Device / BD 33 Gauge Lancet
See description for BD/33G."
502486|NCT00741338|O2|Outcome|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
502487|NCT00741338|O1|Outcome|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
502488|NCT00741338|E2|Reported Event|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low- dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
502489|NCT00741338|E1|Reported Event|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
502490|NCT00741390|B1|Baseline|Entire Study Population|
502491|NCT00741390|P4|Participant Flow|Arm D|Visit1 (V1): BD/33G,OTM/33G,OTM/28G; V2: OTM/33G, OTM/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm D are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the OTM/33G and OTM/28G were used.
502492|NCT00741390|P3|Participant Flow|Arm C|Visit 1 (V1): BD/33G, OTM/33G,ACC/28G Visit 2 (V2): BD/33G, ACC/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm C are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: ACC/28G (Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip). For Visit 2 only the BD/33G and ACC/28G were used.
502493|NCT00741390|P2|Participant Flow|Arm B|Visit 1 (V1):BD/33G,OTM/33G,OTU/28G; Visit 2 (V2):BD/33G, OTU/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing).The lancet/lancing device combinations assigned to Arm B are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTU/28G (OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the BD/33G and OTU/28G were used.
502494|NCT00741390|P1|Participant Flow|Arm A|Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G. The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm A are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips. For Visit 2 only the BD/33G and OTM/28G were used.
502495|NCT00741390|O4|Outcome|OTM/28G - OTM/33G|OneTouch MiniDevice / OneTouch 28g Lancet - OneTouch MiniDevice /BD 33 Gauge Lancet
502499|NCT00741390|O1|Outcome|OTM/28G - OTM/33G|OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to OneTouch Mini Device / BD 33G Lancet
502500|NCT00741390|O3|Outcome|ACC/28G - BD/33G|Accu-Chek Softclix Device/Accu-Chek Softclix 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
502501|NCT00741390|O2|Outcome|OTU/28G - BD/33G|OneTouch UltraSoft Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
502502|NCT00741390|O1|Outcome|OTM/28G - BD/33G|OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
502503|NCT00741390|O5|Outcome|ACC/28G|"Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet
See description for BD/33G."
502507|NCT00741390|O1|Outcome|BD/33G|"BD Lancet Device / BD 33 Gauge Lancet.
In Study Visit 1 each subject was randomly assigned to one of four groups, each subject evaluated three different lancet device/lancet combinations. The order of evaluation of the three systems was randomly assigned for each subject. Subjects started at the middle depth setting of each lancet device. The lowest depth setting for each system yielding sufficient volume for each system was recorded for that subject and used during Visit 2. All subjects whom obtained adequate sample volumes were selected to participate in Study Visit 2."
502508|NCT00741390|E4|Reported Event|Arm D|Visit 1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit (V2) Device: OTM/33G,OTM/28G
502509|NCT00741390|E3|Reported Event|Arm C|Visit 1 (V1) Device: BD/33G,OTM/33G,ACC/28G; Visit 2 (V2)-BD/33G,ACC/28G
502510|NCT00741390|E2|Reported Event|Arm B|Visit 1 (V1) Device: BD/33G,OTM/33G,OTU/28G; Visit 2 (V2) Device: BD/33G,OTU/28G
502511|NCT00741390|E1|Reported Event|Arm A|Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G
502512|NCT00741468|B1|Baseline|All Subjects|"Proellex 50 mg
Proellex: 2, 25 mg Proellex capsules administered daily"
502513|NCT00741468|P1|Participant Flow|All Participants|CYP1A2, Day 8 relative to Day 1 AUC (caffeine probe) CYP2C19, Day 8 relative to Day 1 AUC (omeprazole probe) CYP 2C9, Day 8 relative to Day 1 AUC (tolbutamide probe) CYP2D6, Day 8 relative to Day 1 AUC (dextromethorphan probe) CYP3A4, Day 8 relative to Day 1 AUC (midazolam probe)
502514|NCT00741468|O5|Outcome|CYP3A4|Day 8 relative to Day 1 AUC (midazolam probe)
502515|NCT00741468|O4|Outcome|CYP2D6|Day 8 relative to Day 1 AUC (dextromethorphan probe)
502516|NCT00741468|O3|Outcome|CYP2C19|Day 8 relative to Day 1 AUC (omeprazole probe)
502517|NCT00741468|O2|Outcome|CYP2C9|Day 8 relative to Day 1 AUC (tolbutamide probe)
502518|NCT00741468|O1|Outcome|CYP1A2|Day 8 relative to Day 1 AUC (caffeine probe)
502519|NCT00741468|E1|Reported Event|All Subjects|"Proellex 50 mg
Proellex: 2, 25 mg Proellex capsules administered daily"
502520|NCT00741598|B3|Baseline|Total|Total of all reporting groups
502521|NCT00741598|B2|Baseline|Placebo|placebo equivalent
502522|NCT00741598|B1|Baseline|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
502523|NCT00741598|P2|Participant Flow|Placebo|placebo equivalent
502524|NCT00741598|P1|Participant Flow|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
502525|NCT00741598|O2|Outcome|Placebo|placebo equivalent
502526|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
502527|NCT00741598|O2|Outcome|Placebo|placebo equivalent
502528|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
502529|NCT00741598|O2|Outcome|Placebo|placebo equivalent
502530|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
502531|NCT00741598|O2|Outcome|Placebo|placebo equivalent
502532|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
502533|NCT00741598|O2|Outcome|Placebo|16-week treatment with flexible doses of placebo equivalent
502534|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
502535|NCT00741598|E2|Reported Event|Placebo|placebo equivalent
502536|NCT00741598|E1|Reported Event|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
502537|NCT00741611|B4|Baseline|Total|Total of all reporting groups
502538|NCT00741611|B3|Baseline|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
502539|NCT00741611|B2|Baseline|Drug|Treatment with anti-arrhythmic drugs
502540|NCT00741611|B1|Baseline|Mesh|Ablation with HD Mesh Ablation System
502541|NCT00741611|P3|Participant Flow|Roll-ins|Investigator's first patients treated with the experimental mesh ablation system prior to the start of the study randomization.
502542|NCT00741611|P2|Participant Flow|Drug|Treatment with anti-arrhythmic drugs: treatment was selected by the Investigator and administered in accordance with the approved drug labeling using labeled doses for the atrial fibrillation indication. Per protocol, medications were limited to sotalol, flecainide, propafenone, dofetilide, and amiodarone and did not include rate control medications or calcium chanel blockers.
502543|NCT00741611|P1|Participant Flow|Mesh|Ablation with HD Mesh Ablation System; energy delivered to the heart tissue intended to disrupt the abnormal electrical pathways which cause atrial fibrillation to occur.
502544|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
502545|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
502546|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
502547|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
502548|NCT00741611|O3|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
502549|NCT00741611|O2|Outcome|Drug|Treatment with anti-arrhythmic drugs
502550|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
502551|NCT00741611|O3|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
502552|NCT00741611|O2|Outcome|Drug|Treatment with anti-arrhythmic drugs
502554|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
502555|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
502556|NCT00741611|E3|Reported Event|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
502557|NCT00741611|E2|Reported Event|Drug|Treatment with anti-arrhythmic drugs
502558|NCT00741611|E1|Reported Event|Mesh|Ablation with HD Mesh Ablation System
502559|NCT00741819|B1|Baseline|Inhaled Treprostinil|Inhaled treprostinil was titrated up to 12 breaths four times daily.
502560|NCT00741819|P1|Participant Flow|Inhaled Treprostinil|Inhaled treprostinil was given four times daily at doses titrated up to 12 breaths.
502561|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
502562|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
502563|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
502567|NCT00741819|O1|Outcome|Inhaled Treprostinil|Up to 12 breaths four times daily.
502568|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily
502569|NCT00741819|E1|Reported Event|Inhaled Treprostinil|Inhaled treprostinil was titrated up to 12 breaths four times daily.
502570|NCT00741858|B3|Baseline|Total|Total of all reporting groups
502571|NCT00741858|B2|Baseline|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.
Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
502572|NCT00741858|B1|Baseline|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.
Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
502573|NCT00741858|P2|Participant Flow|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.
Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
502574|NCT00741858|P1|Participant Flow|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.
Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
502575|NCT00741858|O2|Outcome|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.
Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
502576|NCT00741858|O1|Outcome|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.
Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
502577|NCT00741858|E2|Reported Event|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.
Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
502578|NCT00741858|E1|Reported Event|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.
Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
502579|NCT00741936|B3|Baseline|Total|Total of all reporting groups
502580|NCT00741936|B2|Baseline|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502581|NCT00741936|B1|Baseline|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502582|NCT00741936|P2|Participant Flow|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502583|NCT00741936|P1|Participant Flow|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502584|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502585|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502586|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502587|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502588|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502589|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
504419|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
502590|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502591|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502592|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502593|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502594|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502595|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502687|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502596|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502597|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502598|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502599|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502600|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502601|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502602|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502603|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502604|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502605|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502606|NCT00741936|E2|Reported Event|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502607|NCT00741936|E1|Reported Event|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
502608|NCT00741988|B3|Baseline|Total|Total of all reporting groups
502609|NCT00741988|B2|Baseline|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
502610|NCT00741988|B1|Baseline|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
502611|NCT00741988|P2|Participant Flow|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
502612|NCT00741988|P1|Participant Flow|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
502613|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
502614|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
502615|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
502616|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
502617|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
502618|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
502619|NCT00741988|E2|Reported Event|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
502620|NCT00741988|E1|Reported Event|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
502621|NCT00742053|B1|Baseline|PICC Insertion|All patients, aged 18 to 80 years, who required PICC insertion for their standard care will be studied.
502622|NCT00742053|P1|Participant Flow|PICC Insertion|All patients, aged 18 to 80 years, who required Peripherally inserted central catheter (PICC) insertion for their standard care will be studied.
502623|NCT00742053|O1|Outcome|PICC Placement|Patients who require PICC placement
502624|NCT00742053|E1|Reported Event|PICC Insertion|All patients, aged 18 to 80 years, who required PICC insertion for their standard care will be studied.
502625|NCT00742079|B3|Baseline|Total|Total of all reporting groups
502626|NCT00742079|B2|Baseline|2 Placebo, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
503439|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
502627|NCT00742079|B1|Baseline|1 D-cycloserine, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
502628|NCT00742079|P2|Participant Flow|2 Placebo First, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
502629|NCT00742079|P1|Participant Flow|1 D-cycloserine First, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
502630|NCT00742079|O2|Outcome|Placebo, D-cycloserine|Participants will receive 50 mg of placebo 1 hour before a CBT session on Week 1, and they will receive 50 mg of D-cycloserine 1 hour before a CBT session on Week 2.
502631|NCT00742079|O1|Outcome|D-cycloserine, Placebo|Participants will receive 50 mg of D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and they will receive 50 mg of placebo 1 hour before a CBT session on Week 2.
502688|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502632|NCT00742079|E2|Reported Event|2 Placebo, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
502633|NCT00742079|E1|Reported Event|1 D-cycloserine, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
502634|NCT00742170|B3|Baseline|Total|Total of all reporting groups
502635|NCT00742170|B2|Baseline|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.
Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
502636|NCT00742170|B1|Baseline|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.
Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
502637|NCT00742170|P2|Participant Flow|Sham Electroacupuncture Condition|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.
Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
502638|NCT00742170|P1|Participant Flow|Active Electroacupuncture Condition|"Active electroacupuncture condition
Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
502639|NCT00742170|O2|Outcome|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.
Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
502640|NCT00742170|O1|Outcome|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.
Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
502641|NCT00742170|O2|Outcome|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.
Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
502822|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
502642|NCT00742170|O1|Outcome|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.
Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
502685|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502686|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502643|NCT00742170|E2|Reported Event|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.
Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
502644|NCT00742170|E1|Reported Event|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.
Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
502645|NCT00742183|B3|Baseline|Total|Total of all reporting groups
502646|NCT00742183|B2|Baseline|Silvadene|
502647|NCT00742183|B1|Baseline|Mepilex Ag|
502648|NCT00742183|P2|Participant Flow|Silvadene|Silver sulfadiazine 1% cream treatment period will be a maximum of three weeks. Dressing changes of Silvadene® will be performed at least once per day.
502649|NCT00742183|P1|Participant Flow|Mepilex Ag|"Treatment period will be a maximum of three weeks with Silvadene® or Mepilex® Ag.
Dressing changes of Mepilex® Ag will be performed every 5-7 day, depending on the status of the burn"
502650|NCT00742183|O2|Outcome|Silvadene|
502651|NCT00742183|O1|Outcome|Mepilex Ag|
502652|NCT00742183|E2|Reported Event|Silvadene|
502653|NCT00742183|E1|Reported Event|Mepilex Ag|
502654|NCT00742209|B6|Baseline|Total|Total of all reporting groups
502655|NCT00742209|B5|Baseline|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.
502656|NCT00742209|B4|Baseline|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day.
502657|NCT00742209|B3|Baseline|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day.
502658|NCT00742209|B2|Baseline|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
502659|NCT00742209|B1|Baseline|Placebo|Oral GEn (XP13512) placebo on Weeks 1-17
502660|NCT00742209|P5|Participant Flow|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.
502661|NCT00742209|P4|Participant Flow|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502662|NCT00742209|P3|Participant Flow|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502663|NCT00742209|P2|Participant Flow|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
502664|NCT00742209|P1|Participant Flow|Placebo|Oral GEn (XP13512) placebo
502665|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502666|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502667|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502668|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502669|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502670|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502671|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502672|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502673|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502674|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502675|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502676|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502677|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502678|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502680|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502681|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502682|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502683|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502690|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502691|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502692|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502693|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502694|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502695|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502696|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502697|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502698|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502699|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502700|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502701|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502702|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502703|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502704|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502705|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502706|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502707|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502708|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502709|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502710|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502711|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502712|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502713|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502714|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502715|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502716|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502717|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502718|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502719|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502720|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502721|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502722|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502723|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502724|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502920|NCT00742781|O2|Outcome|Vitamin D Supplemented|
502725|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502726|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502727|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502728|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502729|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502730|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502731|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502732|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502733|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502734|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502735|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502736|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502737|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502738|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502739|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502740|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502741|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502742|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502743|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502744|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502745|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502746|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502747|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502748|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502749|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502750|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502751|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502752|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502753|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502754|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502755|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502756|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502757|NCT00742209|O2|Outcome|Average of GEn 1800/2400 mg|Average of GEn 1800 mg group and GEn 2400 mg group
502758|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
502759|NCT00742209|E5|Reported Event|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
502760|NCT00742209|E4|Reported Event|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
502761|NCT00742209|E3|Reported Event|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
502762|NCT00742209|E2|Reported Event|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
502763|NCT00742209|E1|Reported Event|Placebo|Oral GEn (XP13512) placebo
502764|NCT00742235|B3|Baseline|Total|Total of all reporting groups
502765|NCT00742235|B2|Baseline|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
502766|NCT00742235|B1|Baseline|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
502767|NCT00742235|P2|Participant Flow|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL who were offered ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total)
502768|NCT00742235|P1|Participant Flow|Vitamin D Sufficient|Subjects not treated with ergocalciferol and who had 25-OH vitamin D > 32 ng/ml.
502921|NCT00742781|O1|Outcome|Baseline|
502922|NCT00742781|E1|Reported Event|Vitamin D Supplemented|
502923|NCT00742872|B3|Baseline|Total|Total of all reporting groups
502769|NCT00742235|O2|Outcome|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
502770|NCT00742235|O1|Outcome|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
502771|NCT00742235|O2|Outcome|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
502772|NCT00742235|O1|Outcome|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
502773|NCT00742235|E2|Reported Event|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
502774|NCT00742235|E1|Reported Event|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
502775|NCT00742274|B3|Baseline|Total|Total of all reporting groups
502776|NCT00742274|B2|Baseline|BEST MEDICAL THERAPY (BMT) Alone|
502777|NCT00742274|B1|Baseline|TAG Device + Best Medical Therapy (BMT)|
502778|NCT00742274|P2|Participant Flow|Best Medical Therapy (BMT) Alone|BMT alone
502779|NCT00742274|P1|Participant Flow|TAG Device + Best Medical Therapy (BMT)|TAG+BMT
502780|NCT00742274|O2|Outcome|BEST MEDICAL THERAPY (BMT) Alone|
502781|NCT00742274|O1|Outcome|TAG Device + Best Medical Therapy (BMT)|
502782|NCT00742274|E2|Reported Event|BEST MEDICAL THERAPY (BMT) Alone|
502783|NCT00742274|E1|Reported Event|TAG Device + Best Medical Therapy (BMT)|
502784|NCT00742313|B3|Baseline|Total|Total of all reporting groups
502785|NCT00742313|B2|Baseline|Control|Arm B does not have FloSeal Matrix applied to EVH wound bed.
502786|NCT00742313|B1|Baseline|FloSeal|Arm A has FloSeal Matrix applied to EVH wound bed.
502787|NCT00742313|P2|Participant Flow|Non-FloSeal Matrix|FloSeal Matrix was not added to the wound bed
502788|NCT00742313|P1|Participant Flow|FloSeal Matrix|FloSeal Matrix applied to EVH wound bed.
502789|NCT00742313|O2|Outcome|Control|Arm B does not have FloSeal Matrix applied to EVH wound bed.
502790|NCT00742313|O1|Outcome|FloSeal Matrix|Arm A has FloSeal Matrix applied to EVH wound bed.
502791|NCT00742313|E2|Reported Event|Arm B|Arm B does not have FloSeal Matrix applied to EVH wound bed.
502792|NCT00742313|E1|Reported Event|Arm A|Arm A has FloSeal Matrix applied to EVH wound bed.
502793|NCT00742326|B3|Baseline|Total|Total of all reporting groups
502794|NCT00742326|B2|Baseline|Placebo|Placebo once daily for 48 weeks
502795|NCT00742326|B1|Baseline|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks
Pioglitazone"
502796|NCT00742326|P2|Participant Flow|Placebo|Placebo once daily for 48 weeks
502797|NCT00742326|P1|Participant Flow|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks
Pioglitazone"
502798|NCT00742326|O2|Outcome|Placebo|Placebo once daily for 48 weeks
502799|NCT00742326|O1|Outcome|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks
Pioglitazone"
502800|NCT00742326|O2|Outcome|Placebo|Placebo once daily for 48 weeks
502801|NCT00742326|O1|Outcome|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks
Pioglitazone"
502802|NCT00742326|E2|Reported Event|Placebo|Placebo once daily for 48 weeks
502803|NCT00742326|E1|Reported Event|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks
Pioglitazone"
502804|NCT00742391|B3|Baseline|Total|Total of all reporting groups
502805|NCT00742391|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
502806|NCT00742391|B1|Baseline|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
502807|NCT00742391|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
502808|NCT00742391|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
502809|NCT00742391|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
502810|NCT00742391|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
502811|NCT00742391|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
502812|NCT00742391|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
502813|NCT00742391|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
502814|NCT00742391|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
502815|NCT00742417|B3|Baseline|Total|Total of all reporting groups
502816|NCT00742417|B2|Baseline|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
502817|NCT00742417|B1|Baseline|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
502818|NCT00742417|P2|Participant Flow|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
502819|NCT00742417|P1|Participant Flow|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
502820|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
502821|NCT00742417|O1|Outcome|Albutein 5%|"Patients allocated to this arm will undergo plasma exchange with Albutein 5%.
Albutein 5%: 18 Plasma Exchanges using
Albutein 5% or
Sham Procedure
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
503440|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
502823|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
502824|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
502825|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
502826|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
502827|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
502828|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
503363|NCT00734630|O2|Outcome|Placebo|Matching placebo tablets, oral administration
502829|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
502830|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
502831|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
502832|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
502833|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
502834|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
502835|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
502836|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
502837|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
502838|NCT00742417|E2|Reported Event|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
502839|NCT00742417|E1|Reported Event|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks"
502840|NCT00742508|B3|Baseline|Total|Total of all reporting groups
502841|NCT00742508|B2|Baseline|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502842|NCT00742508|B1|Baseline|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502843|NCT00742508|P2|Participant Flow|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502924|NCT00742872|B2|Baseline|Placebo|"Placebo
Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
503441|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
502844|NCT00742508|P1|Participant Flow|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502944|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502945|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
503446|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
502845|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502846|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502847|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502848|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502849|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502850|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502851|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502925|NCT00742872|B1|Baseline|Study|"Mosapride
Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
502926|NCT00742872|P2|Participant Flow|Placebo|"Placebo
Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
502927|NCT00742872|P1|Participant Flow|Study|"Mosapride
Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
502852|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502853|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502854|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502855|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502856|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502857|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502858|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502859|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502928|NCT00742872|O2|Outcome|Placebo|"Placebo
Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
502929|NCT00742872|O1|Outcome|Study|"Mosapride
Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
502930|NCT00742872|E2|Reported Event|Placebo|"Placebo
Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
502860|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502861|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502862|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502863|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502864|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502865|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502866|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502867|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502931|NCT00742872|E1|Reported Event|Study|"Mosapride
Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
502932|NCT00742885|B3|Baseline|Total|Total of all reporting groups
502933|NCT00742885|B2|Baseline|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502868|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502869|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502870|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502871|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502872|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502873|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502874|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502875|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502934|NCT00742885|B1|Baseline|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502935|NCT00742885|P2|Participant Flow|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502876|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502877|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502878|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502879|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502880|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502881|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502882|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502883|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502936|NCT00742885|P1|Participant Flow|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502937|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502884|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502885|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502886|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502887|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502888|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502889|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502890|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502891|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502938|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502939|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502892|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502893|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502894|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502895|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502896|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502897|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502898|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502899|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502940|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502941|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm
502900|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502901|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502902|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502903|NCT00742508|E2|Reported Event|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
502904|NCT00742508|E1|Reported Event|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
502905|NCT00742625|B1|Baseline|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
502906|NCT00742625|P1|Participant Flow|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
502907|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
502908|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
502909|NCT00742625|O3|Outcome|Bortezomib (1.3 mg/m^2) + Int-DAC|Bortezomib (1.3 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
502910|NCT00742625|O2|Outcome|Bortezomib (1.0 mg/m^2) + Int-DAC|Bortezomib (1.0 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
502911|NCT00742625|O1|Outcome|Bortezomib (0.7 mg/m^2) + Int-DAC|Bortezomib (0.7 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
502912|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
502913|NCT00742625|E1|Reported Event|Bortezomib + Daunorubicin + Cytarabine|Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
502914|NCT00742781|B1|Baseline|Vitamin D Supplementation|
502915|NCT00742781|P1|Participant Flow|Vitamin D Supplementation|
502916|NCT00742781|O2|Outcome|Vitamin D Supplemented|
502917|NCT00742781|O1|Outcome|Baseline|
502918|NCT00742781|O2|Outcome|Vitamin D Supplemented|
502919|NCT00742781|O1|Outcome|Baseline|
502942|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502943|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
503447|NCT00743275|E2|Reported Event|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
502946|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502947|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502948|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502949|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502950|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502951|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group.|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502952|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group.|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502953|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502954|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502955|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502956|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502957|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502958|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502959|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502960|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502961|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502962|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502963|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502964|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502965|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502966|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
503008|NCT00743093|E1|Reported Event|Acetaminophen Arm|"acetaminophen
acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
502967|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502968|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502969|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502970|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502971|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502972|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502973|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502974|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502975|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502976|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502977|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502978|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502979|NCT00742885|E2|Reported Event|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502980|NCT00742885|E1|Reported Event|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
502981|NCT00742924|B5|Baseline|Total|Total of all reporting groups
502982|NCT00742924|B4|Baseline|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502983|NCT00742924|B3|Baseline|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502984|NCT00742924|B2|Baseline|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
503009|NCT00743106|B3|Baseline|Total|Total of all reporting groups
503011|NCT00743106|B1|Baseline|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours
Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
502985|NCT00742924|B1|Baseline|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
503448|NCT00743275|E1|Reported Event|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
502986|NCT00742924|P4|Participant Flow|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502987|NCT00742924|P3|Participant Flow|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502988|NCT00742924|P2|Participant Flow|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502989|NCT00742924|P1|Participant Flow|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502990|NCT00742924|O4|Outcome|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502991|NCT00742924|O3|Outcome|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
503010|NCT00743106|B2|Baseline|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.
Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
503849|NCT00746785|P2|Participant Flow|B - 5 mg Olanzapine|"5 mg Olanzapine
olanzapine : 5 mg"
502992|NCT00742924|O2|Outcome|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502993|NCT00742924|O1|Outcome|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502994|NCT00742924|E4|Reported Event|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502995|NCT00742924|E3|Reported Event|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502996|NCT00742924|E2|Reported Event|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502997|NCT00742924|E1|Reported Event|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .
(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.
(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.
See Detailed Description.
cisplatin: Given IV
dexrazoxane hydrochloride: Given IV
doxorubicin hydrochloride: Given IV
etoposide: Given IV
ifosfamide: Given IV
leucovorin calcium: Given IV or orally"
502998|NCT00743093|B3|Baseline|Total|Total of all reporting groups
502999|NCT00743093|B2|Baseline|Placebo Arm|placebo
503000|NCT00743093|B1|Baseline|Acetaminophen Arm|acetaminophen 500 mg
503001|NCT00743093|P2|Participant Flow|Placebo Arm|"placebo
placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
503002|NCT00743093|P1|Participant Flow|Acetaminophen Arm|"acetaminophen
acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
503003|NCT00743093|O2|Outcome|Placebo Arm|"placebo
placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
503004|NCT00743093|O1|Outcome|Acetaminophen Arm|"acetaminophen
acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
503005|NCT00743093|O2|Outcome|Placebo Arm|"placebo
placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
503006|NCT00743093|O1|Outcome|Acetaminophen Arm|"acetaminophen
acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
503007|NCT00743093|E2|Reported Event|Placebo Arm|"placebo
placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
503012|NCT00743106|P2|Participant Flow|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.
Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
503013|NCT00743106|P1|Participant Flow|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours
Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
503014|NCT00743106|O2|Outcome|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.
Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
503474|NCT00743431|B1|Baseline|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
503015|NCT00743106|O1|Outcome|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours
Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
503016|NCT00743106|E2|Reported Event|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.
Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
503017|NCT00743106|E1|Reported Event|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours
Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
503018|NCT00734474|B10|Baseline|Total|Total of all reporting groups
503019|NCT00734474|B9|Baseline|Placebo/Sitagliptin|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503020|NCT00734474|B8|Baseline|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503021|NCT00734474|B7|Baseline|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503022|NCT00734474|B6|Baseline|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
503023|NCT00734474|B5|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503024|NCT00734474|B4|Baseline|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503025|NCT00734474|B3|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503026|NCT00734474|B2|Baseline|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
503027|NCT00734474|B1|Baseline|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
503028|NCT00734474|P9|Participant Flow|Placebo/Sitagliptin|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503029|NCT00734474|P8|Participant Flow|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503030|NCT00734474|P7|Participant Flow|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503031|NCT00734474|P6|Participant Flow|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
503032|NCT00734474|P5|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503236|NCT00734539|E2|Reported Event|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503033|NCT00734474|P4|Participant Flow|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503034|NCT00734474|P3|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503475|NCT00743431|P1|Participant Flow|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
503035|NCT00734474|P2|Participant Flow|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
503036|NCT00734474|P1|Participant Flow|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
503037|NCT00734474|O10|Outcome|Placebo/Sitagliptin (26 Weeks Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503038|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503039|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503040|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503041|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
503042|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503043|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503044|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503045|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
503046|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
503047|NCT00734474|O10|Outcome|Placebo/Sitagliptin (26 Weeks Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503048|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503049|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503050|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503115|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503051|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
503052|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
572707|NCT00923273|B6|Baseline|Total|Total of all reporting groups
503053|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503054|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503055|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
503056|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
503057|NCT00734474|O1|Outcome|LY2189265|"LY2189265 (Dulaglutide): 3.0, 2.0, 1.5, 1.0, 0.75, 0.5, or 0.25 milligrams (mg), subcutaneous (SC), once weekly for up to 104 weeks.
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks"
503058|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503059|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503060|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503061|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503062|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503063|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503064|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503065|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503066|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503067|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503068|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503069|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503070|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503071|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503072|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503442|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
503073|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503074|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503075|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503076|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503077|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503078|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503079|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503080|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503081|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503082|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503083|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503084|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
503085|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503086|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503087|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503088|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
503089|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
503090|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503091|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503092|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503235|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503093|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
503094|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503095|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503096|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503097|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
503098|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
503099|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503100|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503101|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503102|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503103|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503104|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503105|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503106|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503107|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503108|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503109|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503110|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503111|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503112|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503113|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503114|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
504423|NCT00739063|B1|Baseline|Tarceva Daily|Tarceva oral 150 mg daily.
503116|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503117|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503118|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
503119|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503120|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503121|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503122|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
503123|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
503124|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503125|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503126|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503127|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503128|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503129|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503130|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503131|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503132|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503133|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503134|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503135|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503136|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503137|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503138|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503476|NCT00743431|O1|Outcome|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
578582|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
503139|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503140|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503141|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503142|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503143|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503144|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503145|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503146|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503147|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503148|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503149|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503150|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503151|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503152|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503153|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503154|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503155|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503156|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503157|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503158|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503237|NCT00734539|E1|Reported Event|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503159|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
503477|NCT00743431|E1|Reported Event|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
578583|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
503160|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503161|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503162|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503163|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
503164|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
503165|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503166|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503167|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503168|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503169|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503170|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503171|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503172|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503173|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503174|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503175|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503176|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503177|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503178|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503179|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503238|NCT00734578|B4|Baseline|Total|Total of all reporting groups
503850|NCT00746785|P1|Participant Flow|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine
olanzapine : 2.5 mg"
503180|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503478|NCT00743444|B1|Baseline|Entire Study Population|Includes groups randomized to received Drug first and Placebo first.
503181|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503182|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503183|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503184|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
503185|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503186|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503187|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503188|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
503189|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
503190|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503191|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503192|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503193|NCT00734474|E9|Reported Event|Placebo/Sitagliptin (Baseline Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily, for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503194|NCT00734474|E8|Reported Event|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503195|NCT00734474|E7|Reported Event|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503196|NCT00734474|E6|Reported Event|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
503197|NCT00734474|E5|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally, for 104 weeks"
503198|NCT00734474|E4|Reported Event|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
503199|NCT00734474|E3|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
503851|NCT00746785|O3|Outcome|C - Placebo|placebo : placebo
503239|NCT00734578|B3|Baseline|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
578584|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
503200|NCT00734474|E2|Reported Event|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
503201|NCT00734474|E1|Reported Event|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)
Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)
Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
503202|NCT00734500|B1|Baseline|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
503203|NCT00734500|P1|Participant Flow|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
503204|NCT00734500|O1|Outcome|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
503205|NCT00734500|O1|Outcome|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
503206|NCT00734500|E1|Reported Event|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
503207|NCT00734539|B3|Baseline|Total|Total of all reporting groups
503208|NCT00734539|B2|Baseline|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503209|NCT00734539|B1|Baseline|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503210|NCT00734539|P2|Participant Flow|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503211|NCT00734539|P1|Participant Flow|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503212|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for a total of up to 12-13 doses"
503213|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6mg/kg IV/PO twice weekly for a total of up to 12-13 doses"
503214|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly for a total of up to 12-13 doses"
503215|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6mg/kg IV/PO twice weekly for a total of up to 12-13 doses"
503216|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503217|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503218|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503219|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503220|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503221|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503222|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503223|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503224|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503225|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503226|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503227|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503228|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503229|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503230|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503231|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503232|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
503233|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks
fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
503234|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks
placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508184|NCT00757627|O1|Outcome|Week 4 - EQ-5D|
503240|NCT00734578|B2|Baseline|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503241|NCT00734578|B1|Baseline|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503242|NCT00734578|P3|Participant Flow|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
503243|NCT00734578|P2|Participant Flow|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503244|NCT00734578|P1|Participant Flow|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503245|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
503246|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503247|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503248|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
503249|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503250|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503251|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
503252|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503253|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503254|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
503255|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503256|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503257|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
503300|NCT00734604|P3|Participant Flow|S(PRN)/T(OaD)/T(PRN)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
503258|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503259|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503260|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
503261|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503262|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503263|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
503264|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503265|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503266|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
503267|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503268|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503269|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
503270|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503271|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503272|NCT00734578|E3|Reported Event|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
503273|NCT00734578|E2|Reported Event|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503274|NCT00734578|E1|Reported Event|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
503275|NCT00734591|B3|Baseline|Total|Total of all reporting groups
503276|NCT00734591|B2|Baseline|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503277|NCT00734591|B1|Baseline|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503278|NCT00734591|P2|Participant Flow|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503279|NCT00734591|P1|Participant Flow|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503280|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503281|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503282|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503283|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503284|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503285|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503286|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503287|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503288|NCT00734591|E2|Reported Event|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503289|NCT00734591|E1|Reported Event|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
503290|NCT00734604|B7|Baseline|Total|Total of all reporting groups
503291|NCT00734604|B6|Baseline|T(PRN)/S(PRN)/T(OaD)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
503292|NCT00734604|B5|Baseline|T(PRN)/T(OaD)/S(PRN)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
503293|NCT00734604|B4|Baseline|S(PRN)/T(PRN)/T(OaD)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
503294|NCT00734604|B3|Baseline|S(PRN)/T(OaD)/T(PRN)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
503295|NCT00734604|B2|Baseline|T(OaD)/T(PRN)/S(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
503296|NCT00734604|B1|Baseline|T(OaD)/S(PRN)/T(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
503297|NCT00734604|P6|Participant Flow|T(PRN)/S(PRN)/T(OaD)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
503298|NCT00734604|P5|Participant Flow|T(PRN)/T(OaD)/S(PRN)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
503299|NCT00734604|P4|Participant Flow|S(PRN)/T(PRN)/T(OaD)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
508185|NCT00757627|O1|Outcome|Baseline - EQ-5D|
503301|NCT00734604|P2|Participant Flow|T(OaD)/T(PRN)/S(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
503302|NCT00734604|P1|Participant Flow|T(OaD)/S(PRN)/T(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
503303|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503304|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503305|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503306|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503307|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503308|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503309|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503310|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503311|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503312|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503313|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503314|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503315|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503316|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503317|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503318|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503319|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503320|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503321|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503322|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503323|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503324|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503325|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503326|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503327|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503328|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503329|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503330|NCT00734604|O3|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503331|NCT00734604|O2|Outcome|Tadalafil as Needed [T(PRN)]|tadalafil 20 mg as needed [T(PRN)]
503332|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503333|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503334|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503335|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503336|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503337|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503338|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503339|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503340|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503341|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503342|NCT00734604|O2|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503343|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503344|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503345|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503346|NCT00734604|E3|Reported Event|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
503347|NCT00734604|E2|Reported Event|Sildenafil Citrate as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
503348|NCT00734604|E1|Reported Event|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
503349|NCT00734617|B3|Baseline|Total|Total of all reporting groups
503350|NCT00734617|B2|Baseline|More Dependent|
503351|NCT00734617|B1|Baseline|Less Dependent|
503352|NCT00734617|P2|Participant Flow|More Dependent|
503353|NCT00734617|P1|Participant Flow|Less Dependent|
503354|NCT00734617|O2|Outcome|More Dependent|
503355|NCT00734617|O1|Outcome|Less Dependent|
503356|NCT00734617|E2|Reported Event|More Dependent|
503357|NCT00734617|E1|Reported Event|Less Dependent|
503358|NCT00734630|B3|Baseline|Total|Total of all reporting groups
503359|NCT00734630|B2|Baseline|Placebo|Matching placebo tablets, oral administration
503360|NCT00734630|B1|Baseline|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
503361|NCT00734630|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
503362|NCT00734630|P1|Participant Flow|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
503364|NCT00734630|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
503365|NCT00734630|O2|Outcome|Placebo|Matching placebo tablets, oral administration
503366|NCT00734630|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
503367|NCT00734630|E2|Reported Event|Placebo|Matching placebo tablets, oral administration
503368|NCT00734630|E1|Reported Event|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
503369|NCT00734656|B1|Baseline|All Study Participants|All study participants enrolled in Lab Session 1
503370|NCT00734656|P4|Participant Flow|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
503371|NCT00734656|P3|Participant Flow|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
503372|NCT00734656|P2|Participant Flow|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
503373|NCT00734656|P1|Participant Flow|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
503374|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
503375|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
503376|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
503377|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
503378|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
503379|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
503380|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
503381|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
503382|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
503383|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
503384|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
503385|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
503386|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
503387|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
503388|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
503389|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
503390|NCT00734656|E4|Reported Event|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
503391|NCT00734656|E3|Reported Event|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
503392|NCT00734656|E2|Reported Event|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
503393|NCT00734656|E1|Reported Event|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
503394|NCT00734734|B1|Baseline|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
503395|NCT00734734|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
503396|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.
503397|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
503398|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
503399|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
503400|NCT00734734|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
503401|NCT00734747|B1|Baseline|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD
MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
503438|NCT00743275|P1|Participant Flow|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
503402|NCT00734747|P1|Participant Flow|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD
Medigus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
503403|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD
MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
503404|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD
MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
503405|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD
MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
503406|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD
MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
503407|NCT00734747|E1|Reported Event|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD
MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
503408|NCT00743197|B3|Baseline|Total|Total of all reporting groups
503409|NCT00743197|B2|Baseline|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
503410|NCT00743197|B1|Baseline|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
503411|NCT00743197|P2|Participant Flow|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
503412|NCT00743197|P1|Participant Flow|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
503413|NCT00743197|O2|Outcome|Medical Treatment Group|
503414|NCT00743197|O1|Outcome|Usual Care Group|
503415|NCT00743197|E2|Reported Event|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
503416|NCT00743197|E1|Reported Event|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
503417|NCT00743249|B3|Baseline|Total|Total of all reporting groups
503418|NCT00743249|B2|Baseline|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
503419|NCT00743249|B1|Baseline|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
503420|NCT00743249|P2|Participant Flow|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
503421|NCT00743249|P1|Participant Flow|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
503422|NCT00743249|O2|Outcome|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
503423|NCT00743249|O1|Outcome|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
503424|NCT00743249|O2|Outcome|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
503425|NCT00743249|O1|Outcome|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
503426|NCT00743249|E2|Reported Event|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
503427|NCT00743249|E1|Reported Event|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
503428|NCT00743262|B1|Baseline|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
503429|NCT00743262|P1|Participant Flow|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
503430|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
503431|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
503432|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
503433|NCT00743262|E1|Reported Event|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
503434|NCT00743275|B3|Baseline|Total|Total of all reporting groups
503435|NCT00743275|B2|Baseline|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
503436|NCT00743275|B1|Baseline|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
503437|NCT00743275|P2|Participant Flow|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
503443|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
503444|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
503445|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
503449|NCT00743288|B1|Baseline|Melphalan and Panobinostat (LBH589)|"Schedule A: 10mg/daily of LBH589 per orem (PO) on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.
Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
503450|NCT00743288|P7|Participant Flow|Melphalan and Panobinostat Schedule D3|20 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
503451|NCT00743288|P6|Participant Flow|Melphalan and Panobinostat Schedule D2|15 mg/daily of LBH589 PO and melphalan PO at 0.10 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
503452|NCT00743288|P5|Participant Flow|Melphalan and Panobinostat Schedule D1|15 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
503453|NCT00743288|P4|Participant Flow|Melphalan and Panobinostat Schedule C|20 mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
503454|NCT00743288|P3|Participant Flow|Melphalan and Panobinostat Schedule B2|20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
503455|NCT00743288|P2|Participant Flow|Melphalan and Panobinostat Schedule B1|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
503456|NCT00743288|P1|Participant Flow|Melphalan and Panobinostat Schedule A|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
503457|NCT00743288|O5|Outcome|Melphalan and Panobinostat All Patients|Data for all patients irrespective of dosage
503458|NCT00743288|O4|Outcome|Melphalan and Panobinostat Schedule D|"Schedules D1, D2 and D3
D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1"
503459|NCT00743288|O3|Outcome|Melphalan and Panobinostat Schedule C|0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
503460|NCT00743288|O2|Outcome|Melphalan and Panobinostat Schedule B|"Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1.
B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1"
503461|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule A|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
503462|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule D3|20mg daily LBH589 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1
503463|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule D3|20mg daily LBH589 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1
503464|NCT00743288|O1|Outcome|Melphalan and Panobinostat|"Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.
Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
503465|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule B|"B1: 10mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.
B2: 20mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1."
503466|NCT00743288|E1|Reported Event|Melphalan and Panobinostat|"Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.
Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
503467|NCT00743366|B1|Baseline|Overall Number of Baseline Participants|
503468|NCT00743366|P2|Participant Flow|Placebo, Quetiapine (200mg/Day)|Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).
503469|NCT00743366|P1|Participant Flow|Quetiapine (200mg/Day), Placebo|Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours).
503470|NCT00743366|O2|Outcome|Placebo, Marijuana|
508186|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
503471|NCT00743366|O1|Outcome|Quetiapine, Marijuana|"quetiapine's effects on marijuana withdrawal and relapse
Marijuana: 0,6.9% THC
Quetiapine: 0, 200 mg/day"
503472|NCT00743366|E2|Reported Event|Placebo, Quetiapine (200mg/Day)|Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).
503473|NCT00743366|E1|Reported Event|Quetiapine (200mg/Day), Placebo|Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours).
578585|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
503479|NCT00743444|P2|Participant Flow|Placebo First, Then AZD3355|65 mg drug or placebo capsules, oral, 3 single doses
503480|NCT00743444|P1|Participant Flow|AZD3355 First, Then Placebo|65 mg drug or placebo capsules, oral, 3 single doses
503481|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
503482|NCT00743444|O2|Outcome|Placebo|placebo capsules, oral, 3 single doses
503483|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
503484|NCT00743444|O2|Outcome|Placebo|placebo capsules, oral, 3 single doses
503485|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
503486|NCT00743444|E2|Reported Event|Placebo|placebo capsules, oral, 3 single doses
503487|NCT00743444|E1|Reported Event|AZD3355|65 mg drug capsules, oral, 3 single doses
503488|NCT00745368|B1|Baseline|Raltegravir|Raltegravir 400 mg tablets twice daily
503489|NCT00745368|P1|Participant Flow|Raltegravir|Raltegravir 400 mg tablets twice daily
503490|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
503491|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
503492|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
503493|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
503494|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
503495|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
503496|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
503497|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
503498|NCT00745368|E1|Reported Event|Raltegravir|Raltegravir 400 mg tablets twice daily
503499|NCT00745498|B4|Baseline|Total|Total of all reporting groups
503500|NCT00745498|B3|Baseline|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
503501|NCT00745498|B2|Baseline|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
503502|NCT00745498|B1|Baseline|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
503503|NCT00745498|P3|Participant Flow|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
503504|NCT00745498|P2|Participant Flow|Introp IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
503505|NCT00745498|P1|Participant Flow|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
503506|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
503507|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
503508|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
503509|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
503510|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
503511|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
503512|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
503513|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
503514|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
503515|NCT00745498|E3|Reported Event|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
503516|NCT00745498|E2|Reported Event|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
503517|NCT00745498|E1|Reported Event|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
503518|NCT00745823|B3|Baseline|Total|Total of all reporting groups
503519|NCT00745823|B2|Baseline|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503520|NCT00745823|B1|Baseline|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503521|NCT00745823|P2|Participant Flow|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503522|NCT00745823|P1|Participant Flow|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503523|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503565|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503524|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503525|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503526|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503527|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg b.i.d. administered with TRUVADA™
503528|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg PO q.d. plus placebo to raltegravir PO b.i.d. plus one tablet of TRUVADA™ for 96 weeks
503529|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503530|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503531|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503532|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503533|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503534|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503535|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503536|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503537|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503538|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503539|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503540|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503541|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503542|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503543|NCT00745823|E2|Reported Event|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
503544|NCT00745823|E1|Reported Event|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
503545|NCT00745875|B3|Baseline|Total|Total of all reporting groups
503546|NCT00745875|B2|Baseline|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
503547|NCT00745875|B1|Baseline|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
503548|NCT00745875|P2|Participant Flow|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
503549|NCT00745875|P1|Participant Flow|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
503550|NCT00745875|O2|Outcome|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
503551|NCT00745875|O1|Outcome|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
503552|NCT00745875|O2|Outcome|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
503553|NCT00745875|O1|Outcome|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
503554|NCT00745875|E2|Reported Event|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
503555|NCT00745875|E1|Reported Event|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
503556|NCT00745901|B3|Baseline|Total|Total of all reporting groups
503557|NCT00745901|B2|Baseline|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503558|NCT00745901|B1|Baseline|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503559|NCT00745901|P2|Participant Flow|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503560|NCT00745901|P1|Participant Flow|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503561|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503562|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503563|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503564|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
508187|NCT00757627|O1|Outcome|Etoricoxib (Week 4)|Etoricoxib 60 mg q.d.
503566|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503567|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503568|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503569|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503570|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503571|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503628|NCT00746096|O1|Outcome|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
503572|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503573|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503574|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503575|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503576|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503577|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503578|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503579|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503580|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503581|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503582|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503583|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503584|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503585|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503586|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503587|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503588|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503589|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503590|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503591|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503592|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503593|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503594|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503595|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503596|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503597|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503598|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503599|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503600|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503601|NCT00745901|E2|Reported Event|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
503602|NCT00745901|E1|Reported Event|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
503603|NCT00745940|B3|Baseline|Total|Total of all reporting groups
503604|NCT00745940|B2|Baseline|MBCT Control Group|Control group waited.
503686|NCT00746356|O1|Outcome|Participants Successfully Implanted With Devices|All participants successfully implanted with an ICD or CRT-D
503605|NCT00745940|B1|Baseline|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
503606|NCT00745940|P2|Participant Flow|MBCT Control Group|Control group waited.
503629|NCT00746096|E2|Reported Event|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
503630|NCT00746096|E1|Reported Event|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
503607|NCT00745940|P1|Participant Flow|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
503608|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
503609|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
503610|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
503611|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
503612|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
503613|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
503614|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
503615|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
503616|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
503617|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
503618|NCT00745940|E2|Reported Event|MBCT Control Group|Control group waited.
503619|NCT00745940|E1|Reported Event|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
503620|NCT00746096|B3|Baseline|Total|Total of all reporting groups
503621|NCT00746096|B2|Baseline|Placebo|Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
503622|NCT00746096|B1|Baseline|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
503623|NCT00746096|P2|Participant Flow|Placebo|"Patient received placebo orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication.
The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle."
503624|NCT00746096|P1|Participant Flow|IKH-01|"Patient received IKH-01 orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication.
The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle."
503625|NCT00746096|O2|Outcome|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
503626|NCT00746096|O1|Outcome|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
503627|NCT00746096|O2|Outcome|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
503632|NCT00746187|B2|Baseline|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
503633|NCT00746187|B1|Baseline|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm
ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
503634|NCT00746187|P2|Participant Flow|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
503635|NCT00746187|P1|Participant Flow|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm
ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
503636|NCT00746187|O2|Outcome|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
503637|NCT00746187|O1|Outcome|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm
ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
503638|NCT00746187|E2|Reported Event|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
503639|NCT00746187|E1|Reported Event|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm
ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
503640|NCT00746239|B1|Baseline|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|Panic disorder subjects who were on Escitalopram (5-40 mg) received either Ramelteon 8 mg OR Placebo. As the study was terminated prematurely, the blind was never opened. Thus, it is not known as to how many were in each arm. As a result we are combining all subjects in one group for presenting in this record.
503641|NCT00746239|P1|Participant Flow|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|Subjects were randomly assigned to receive either Ramelteon 8 mg and Escitalopram (5-40 mg) OR Placebo and Escitalopram (5-40 mg). However, as the blind was never opened, we are combining all subjects in one group for presenting in this record.
503642|NCT00746239|O1|Outcome|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|11 subjects enrolled- 6 withdrew from study/the blind was never opened as the study was terminated prematurely for lack of continued funding- the data for outcome measures was never collected/compiled/analyzed
503643|NCT00746239|E1|Reported Event|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|"Panic disorder subjects who were on Escitalopram received either Escitalopram OR Placebo - as the study terminated prematurely, the blind was never opened; thus it is not known as to how many were in each arm- as a result we are not combining all in one group for presenting in this record.
Ramelteon and Escitalopram: Ramelteon 8 mg and Escitalopram (5-40 mg)"
503644|NCT00746330|B5|Baseline|Total|Total of all reporting groups
503645|NCT00746330|B4|Baseline|PL, MFF, F12M, F12D|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
503646|NCT00746330|B3|Baseline|MFF, F12D, PL, F12M|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
503647|NCT00746330|B2|Baseline|F12D, F12M, MFF, PL|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
503683|NCT00746356|O1|Outcome|Participants With CRT-D Devices|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle
503684|NCT00746356|O1|Outcome|Participants With Single or Dual Chamber ICDs|Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold in the right ventricle
503685|NCT00746356|O1|Outcome|Participants With Dual Chamber ICDs or CRTD Devices|Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold
503648|NCT00746330|B1|Baseline|F12M, PL, F12D, MFF|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
503694|NCT00746395|O1|Outcome|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
503695|NCT00746395|O2|Outcome|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
503696|NCT00746395|O1|Outcome|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
503697|NCT00746395|E2|Reported Event|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
504814|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
503649|NCT00746330|P4|Participant Flow|PL, MFF, F12M, F12D|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
503650|NCT00746330|P3|Participant Flow|MFF, F12D, PL, F12M|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
503651|NCT00746330|P2|Participant Flow|F12D, F12M, MFF, PL|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
503652|NCT00746330|P1|Participant Flow|F12M, PL, F12D, MFF|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via Pressurized Metered Dose Inhaler (pMDI) + placebo to formoterol fumarate via Dry Powder Inhaler (DPI); Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
503653|NCT00746330|O3|Outcome|F12D|Formoterol fumarate 12 μg via DPI/Placebo via pMDI
503654|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
503655|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
503656|NCT00746330|O3|Outcome|F12D|Formoterol fumarate 12 μg via DPI/Placebo via pMDI
503657|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
503658|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
503659|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
503660|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
503661|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
503662|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
503663|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
503664|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
503665|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
503666|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
503667|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
503668|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
503669|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
503670|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
503671|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
503672|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
503673|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
503674|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
503675|NCT00746330|E4|Reported Event|Placebo|Placebo via pMDI/ Placebo via DPI
503676|NCT00746330|E3|Reported Event|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
503677|NCT00746330|E2|Reported Event|F12D|Placebo Via pMDI/ Formoterol Fumarate 12 μg Via DPI
503678|NCT00746330|E1|Reported Event|F12M|Formoterol Fumarate 12 μg Via pMDI/ Placebo Via DPI
503679|NCT00746356|B1|Baseline|All Patients|All patients enrolled in the study
503680|NCT00746356|P2|Participant Flow|ICD Device Patients|All patients with an implantable cardioverter defibrillator (ICD) device enrolled in the study.
503681|NCT00746356|P1|Participant Flow|CRT-D Device Patients|All patients with a cardiac resynchronization therapy device (CRT-D)enrolled in the study.
503682|NCT00746356|O1|Outcome|Participants With CRT-D Devices|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle.
503687|NCT00746356|E1|Reported Event|All Patients|All patients enrolled in the study
503689|NCT00746395|B2|Baseline|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
503690|NCT00746395|B1|Baseline|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
503691|NCT00746395|P2|Participant Flow|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
503692|NCT00746395|P1|Participant Flow|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
503693|NCT00746395|O2|Outcome|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
504928|NCT00748072|O1|Outcome|Saline Solution|patients treated with 1 ml of s.c. saline solution
503698|NCT00746395|E1|Reported Event|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
503699|NCT00746421|B3|Baseline|Total|Total of all reporting groups
503700|NCT00746421|B2|Baseline|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
503701|NCT00746421|B1|Baseline|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
503702|NCT00746421|P2|Participant Flow|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
503703|NCT00746421|P1|Participant Flow|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
503704|NCT00746421|O2|Outcome|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
503705|NCT00746421|O1|Outcome|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
503706|NCT00746421|O2|Outcome|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
503707|NCT00746421|O1|Outcome|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
503708|NCT00746421|E2|Reported Event|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
503709|NCT00746421|E1|Reported Event|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
503710|NCT00746512|B5|Baseline|Total|Total of all reporting groups
503711|NCT00746512|B4|Baseline|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
503712|NCT00746512|B3|Baseline|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
503713|NCT00746512|B2|Baseline|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
503714|NCT00746512|B1|Baseline|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
503715|NCT00746512|P4|Participant Flow|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
503716|NCT00746512|P3|Participant Flow|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
503717|NCT00746512|P2|Participant Flow|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
503718|NCT00746512|P1|Participant Flow|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
503719|NCT00746512|O4|Outcome|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
503720|NCT00746512|O3|Outcome|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
503721|NCT00746512|O2|Outcome|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
503722|NCT00746512|O1|Outcome|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
503723|NCT00746512|O4|Outcome|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
503724|NCT00746512|O3|Outcome|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
503725|NCT00746512|O2|Outcome|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
503726|NCT00746512|O1|Outcome|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
503727|NCT00746512|E4|Reported Event|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
503728|NCT00746512|E3|Reported Event|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
503729|NCT00746512|E2|Reported Event|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
503730|NCT00746512|E1|Reported Event|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
503731|NCT00746551|B3|Baseline|Total|Total of all reporting groups
503753|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
503754|NCT00746564|E1|Reported Event|SJM Confirm Device|All patients in this study received the SJM Confirm device.
503852|NCT00746785|O2|Outcome|B - 5 mg Olanzapine|"5 mg Olanzapine
olanzapine : 5 mg"
503853|NCT00746785|O1|Outcome|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine
olanzapine : 2.5 mg"
503732|NCT00746551|B2|Baseline|Ferrous Fumarate, Ferri-6, Oral Tablet|Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
503757|NCT00746590|O1|Outcome|Prolarix Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
503758|NCT00746590|E1|Reported Event|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
503733|NCT00746551|B1|Baseline|Iron Sucrose, Venofer, Intravenous Drug|Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
503734|NCT00746551|P2|Participant Flow|Ferrous Fumarate, Ferri-6®, Oral Tablet|In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.
503735|NCT00746551|P1|Participant Flow|Iron Sucrose, Venofer®, Intravenous Drug|Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
503736|NCT00746551|O2|Outcome|Ferrous Fumarate, Ferri-6, Oral Tablet|The patients in the control group (OFF-group) were instructed to have 3 oral ferrous fumarate tablets (Ferli-6®, Continental-Pharm, Thailand) daily with a total of 200 mg elemental iron per day until delivery. The remaining of OFF tablets was counted at every visit to evaluate patient compliance. Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
503737|NCT00746551|O1|Outcome|Iron Sucrose, Venofer, Intravenous Drug|"Patients in the study group (ISC-group) were given 500 mg of ISC (Venofer®, Vifor International AG, St. Gallen, Switzerland) in three divided doses. The administration was given weekly with the maximum dose of 200 mg from GA 33 to 35 weeks. Thereafter, no other iron supplementation was given to this group until delivery. In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.
If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.
Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
503738|NCT00746551|O2|Outcome|Ferrous Fumarate, Ferri-6, Oral Tablet|The patients in the control group (OFF-group) were instructed to have 3 oral ferrous fumarate tablets (Ferli-6®, Continental-Pharm, Thailand) daily with a total of 200 mg elemental iron per day until delivery. The remaining of OFF tablets was counted at every visit to evaluate patient compliance. Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
503739|NCT00746551|O1|Outcome|Iron Sucrose, Venofer, Intravenous Drug|"Patients in the study group (ISC-group) were given 500 mg of ISC (Venofer®, Vifor International AG, St. Gallen, Switzerland) in three divided doses. The administration was given weekly with the maximum dose of 200 mg from GA 33 to 35 weeks. Thereafter, no other iron supplementation was given to this group until delivery. In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.
If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.
Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
503740|NCT00746551|E2|Reported Event|Ferrous Fumarate, Ferri-6®, Oral Tablet|Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
503741|NCT00746551|E1|Reported Event|Iron Sucrose, Venofer®, Intravenous Drug|"In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.
If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.
Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
503742|NCT00746564|B1|Baseline|Open Label|All patients who were implanted with the SJM Confirm device.
503743|NCT00746564|P1|Participant Flow|SJM Confirm Device|All patients in this study received the St. Jude Medical (SJM Confirm device.
503744|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with the SJM Confirm device.
503745|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with an SJM Confirm device.
503746|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with an SJM Confirm device.
503747|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
503748|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
503749|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
503750|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
503751|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
503752|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
503811|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
503755|NCT00746590|B1|Baseline|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
503756|NCT00746590|P1|Participant Flow|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
503862|NCT00746798|P4|Participant Flow|Placebo|Participants who received placebo (saline) given one time subcutaneously
503759|NCT00746668|B1|Baseline|All Study Participants|All subjects' reading performances were initially assessed before training began. Reading performance were assessed using sentences displayed on a computer monitor. Two lines of text were presented at the center of the monitor with each subject seated at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test.
503760|NCT00746668|P7|Participant Flow|Group 6|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
503761|NCT00746668|P6|Participant Flow|Group 5|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP)"
503762|NCT00746668|P5|Participant Flow|Group 4|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements)"
503763|NCT00746668|P4|Participant Flow|Group 3|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements)"
503764|NCT00746668|P3|Participant Flow|Group 2|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
503765|NCT00746668|P2|Participant Flow|Group 1|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP)"
503766|NCT00746668|P1|Participant Flow|Control Group|Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed.
503767|NCT00746668|O4|Outcome|Arm 4: Assessment After Module 3|Assessment after six-weeks of training in Module 3 (RSVP Reading).
503768|NCT00746668|O3|Outcome|Arm 3: Assessment After Module 2|Assessment after six-weeks of training in Module 2 (Eye Movement Training).
503769|NCT00746668|O2|Outcome|Arm 2: Assessment After Module 1|Assessment after six-weeks of training in Module 1 (PRL Awareness Training).
503770|NCT00746668|O1|Outcome|Arm 1: Pre-Training|Baseline Assessment prior to training.
503771|NCT00746668|E7|Reported Event|Group 6|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
503812|NCT00746733|O2|Outcome|Adderall XR|
503813|NCT00746733|O1|Outcome|Vyvanse|
503814|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
503815|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
503816|NCT00746733|O2|Outcome|Adderall XR|
503817|NCT00746733|O1|Outcome|Vyvanse|
503772|NCT00746668|E6|Reported Event|Group 5|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP)"
503860|NCT00746798|B2|Baseline|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
503861|NCT00746798|B1|Baseline|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
503773|NCT00746668|E5|Reported Event|Group 4|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements)"
503774|NCT00746668|E4|Reported Event|Group 3|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements)"
503775|NCT00746668|E3|Reported Event|Group 2|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
503776|NCT00746668|E2|Reported Event|Group 1|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.
Subjects in this group were trained according to the following counterbalanced module order:
Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP)"
503777|NCT00746668|E1|Reported Event|Control Group|Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed.
503778|NCT00746694|B1|Baseline|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
503779|NCT00746694|P1|Participant Flow|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
503780|NCT00746694|O1|Outcome|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
503781|NCT00746694|O1|Outcome|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
503782|NCT00746694|E1|Reported Event|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
503783|NCT00746733|B1|Baseline|Entire Study Population|
503784|NCT00746733|P2|Participant Flow|Adderall XR First|Adderall XR 20 mg dosed once in the first intervention, Vyvanse 50mg dosed once in the second intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the third intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the fourth intervention.
503785|NCT00746733|P1|Participant Flow|Vyvanse First|Vyvanse 50mg dosed once in the first intervention, Adderall XR 20 mg dosed once in the second intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the third intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the fourth intervention.
503786|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
503787|NCT00746733|O1|Outcome|Adderall XR|
503788|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
503789|NCT00746733|O1|Outcome|Adderall XR|
503790|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
503791|NCT00746733|O1|Outcome|Adderall XR|
503792|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
503793|NCT00746733|O1|Outcome|Adderall XR|
503794|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
503795|NCT00746733|O1|Outcome|Adderall XR|
503796|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
503797|NCT00746733|O1|Outcome|Adderall XR|
503798|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
503799|NCT00746733|O1|Outcome|Adderall XR|
503800|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
503801|NCT00746733|O1|Outcome|Adderall XR|
503802|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
503803|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
503804|NCT00746733|O2|Outcome|Adderall XR|
503805|NCT00746733|O1|Outcome|Vyvanse|
503806|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
503807|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
503808|NCT00746733|O2|Outcome|Adderall XR|
503809|NCT00746733|O1|Outcome|Vyvanse|
503810|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
503855|NCT00746785|E2|Reported Event|B - 5 mg Olanzapine|"5 mg Olanzapine
olanzapine : 5 mg"
503856|NCT00746785|E1|Reported Event|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine
olanzapine : 2.5 mg"
503857|NCT00746798|B5|Baseline|Total|Total of all reporting groups
503858|NCT00746798|B4|Baseline|Placebo|Participants who received placebo (saline) given one time subcutaneously
503859|NCT00746798|B3|Baseline|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
503863|NCT00746798|P3|Participant Flow|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
503864|NCT00746798|P2|Participant Flow|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
503865|NCT00746798|P1|Participant Flow|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
503866|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
503867|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
503868|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
503869|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
503870|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
503871|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
503872|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
503873|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
503874|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
503875|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
503876|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
503877|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
503878|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
503879|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
503880|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
503881|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
503882|NCT00746798|E4|Reported Event|Placebo|Participants who received placebo (saline) given one time subcutaneously
503883|NCT00746798|E3|Reported Event|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
503884|NCT00746798|E2|Reported Event|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
503885|NCT00746798|E1|Reported Event|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
503886|NCT00746863|B3|Baseline|Total|Total of all reporting groups
503887|NCT00746863|B2|Baseline|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
503888|NCT00746863|B1|Baseline|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
503889|NCT00746863|P2|Participant Flow|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
503890|NCT00746863|P1|Participant Flow|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
503891|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
508188|NCT00757627|O1|Outcome|Etoricoxib (Baseline)|Etoricoxib 60 mg q.d.
503892|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
503893|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
503894|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
503982|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
503895|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
503896|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
503897|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
503898|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
503899|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
503900|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
503901|NCT00746863|E2|Reported Event|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
503902|NCT00746863|E1|Reported Event|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
503903|NCT00746889|B3|Baseline|Total|Total of all reporting groups
503904|NCT00746889|B2|Baseline|Placebo|Intraarticular injection of 0.9% saline
503905|NCT00746889|B1|Baseline|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
503906|NCT00746889|P2|Participant Flow|Placebo|Intraarticular injection of 0.9% saline
503907|NCT00746889|P1|Participant Flow|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
503908|NCT00746889|O2|Outcome|Noninflammatory Patients Who Received Corticosteroid Injection|Patients with noninflammatory characteristics on ultrasound who received saline placebo knee injections
503909|NCT00746889|O1|Outcome|Inflammatory Patients Who Received Corticosteroid Injections|Patients with inflammatory characteristics on ultrsaound who were treated with corticosteroid knee injections
503910|NCT00746889|O2|Outcome|Placebo|Intraarticular injection of 0.9% saline
503911|NCT00746889|O1|Outcome|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
503912|NCT00746889|E2|Reported Event|Placebo|Intraarticular injection of 0.9% saline
503913|NCT00746889|E1|Reported Event|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
503914|NCT00746941|B5|Baseline|Total|Total of all reporting groups
503915|NCT00746941|B4|Baseline|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503916|NCT00746941|B3|Baseline|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment."
503917|NCT00746941|B2|Baseline|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment."
503918|NCT00746941|B1|Baseline|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56)."
503919|NCT00746941|P4|Participant Flow|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503974|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
503975|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
503976|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
503920|NCT00746941|P3|Participant Flow|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment."
503921|NCT00746941|P2|Participant Flow|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment."
578586|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
503922|NCT00746941|P1|Participant Flow|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56)."
503923|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|"Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Also includes participants who were randomized to receive local standard of care (only) and added mefloquine at Week 4 or Week 8."
503924|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
503925|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503926|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
503927|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503928|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
503929|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503930|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
503931|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503932|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
503933|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503934|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
503935|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503936|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
503937|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503938|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
503939|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503940|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
503941|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503942|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
503983|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
578587|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
503943|NCT00746941|E4|Reported Event|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
503944|NCT00746941|E3|Reported Event|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
Participants who chose to add mefloquine at Week 8 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started."
503945|NCT00746941|E2|Reported Event|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
Participants who chose to add mefloquine at Week 4 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started."
503946|NCT00746941|E1|Reported Event|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
Participants who chose to add mefloquine at Weeks 4 or 8 to their standard of care treatment are counted in this treatment arm until the time of switching to mefloquine treatment."
503947|NCT00746954|B1|Baseline|Arm 1|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
503948|NCT00746954|P3|Participant Flow|Arm 3 BUS to ACET to PLA|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
503949|NCT00746954|P2|Participant Flow|Arm 2 Acet to Placebo to Bus|Each patient will act as their own control, with comparisons over three nights, each night given actetazolamide (Acet 250mg), or placebo or buspirone (Bus 20mg),
503950|NCT00746954|P1|Participant Flow|Arm 1 Control to ACET to BUS|Each patient will act as their own control, with comparisons over three nights, this is placebo
503951|NCT00746954|O3|Outcome|PLACEBO|Each patient will act as their own control, with comparisons over three nights
503952|NCT00746954|O2|Outcome|ACETAZOLAMIDE|Each patient will act as their own control, with comparisons over three nights
503953|NCT00746954|O1|Outcome|BUSPIRONE|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
503954|NCT00746954|E1|Reported Event|Arm 1|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
503955|NCT00747006|B4|Baseline|Total|Total of all reporting groups
503956|NCT00747006|B3|Baseline|Amendment 1 Type 2 Diabetes|Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
503957|NCT00747006|B2|Baseline|Original Protocol Type 2 Diabetes|Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
503958|NCT00747006|B1|Baseline|Original Protocol Type 1 Diabetes|Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
503959|NCT00747006|P3|Participant Flow|Amendment 1 Type 2 Diabetes|Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
503960|NCT00747006|P2|Participant Flow|Original Protocol Type 2 Diabetes|Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
503961|NCT00747006|P1|Participant Flow|Original Protocol Type 1 Diabetes|Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
503962|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
503963|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
503964|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
503965|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
503966|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
503967|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
503968|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
503969|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
503970|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
503971|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
503972|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
503973|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
508189|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
503977|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
503978|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
503979|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
503980|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
503981|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
503984|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
503985|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
503986|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
503987|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
503988|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
503989|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
503990|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
503991|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
503992|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
503993|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
503994|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
503995|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
503996|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
503997|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
503998|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
503999|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504000|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504001|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504002|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504003|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504004|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504005|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504006|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504007|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504008|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504009|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504010|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504011|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504012|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504013|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504014|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504015|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504016|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504017|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504018|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504019|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504020|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504021|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504022|NCT00747006|E4|Reported Event|Humalog Amendment 1 Type 2 DM|Humalog treated subjects in protocol amendment 1
504023|NCT00747006|E3|Reported Event|TI Amendment 1 Type 2 DM|Technosphere Insulin treated subjects in protocol amendment 1
504024|NCT00747006|E2|Reported Event|TI Original Protocol Type 2 DM|Original protocol type 2 diabetes mellitus subjects
504025|NCT00747006|E1|Reported Event|TI Original Protocol Type 1 DM|Original protocol type 1 diabetes mellitus subjects
504026|NCT00747149|B3|Baseline|Total|Total of all reporting groups
504027|NCT00747149|B2|Baseline|Rosuvastatin 20 mg (Initial)|20 mg RSV as initial dose
504028|NCT00747149|B1|Baseline|Rosuvastatin 10 mg (Initial)|10 mg rosuvastatin (RSV) as initial dose
504029|NCT00747149|P2|Participant Flow|Rosuvastatin Non-titrated|10 mg RSV or 20 mg RSV
504030|NCT00747149|P1|Participant Flow|Rosuvastatin Titrated|10 mg rosuvastatin (RSV) as initial dose followed by 20 mg RSV as titrated dose or 20 mg rosuvastatin (RSV) as initial dose followed by 40 mg RSV as titrated dose
504031|NCT00747149|O4|Outcome|Rosuvastatin 40 mg (Titrated)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
504032|NCT00747149|O3|Outcome|Rosuvastatin 20 mg (Titrated)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
504071|NCT00747344|B3|Baseline|Total|Total of all reporting groups
504072|NCT00747344|B2|Baseline|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
504073|NCT00747344|B1|Baseline|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
504033|NCT00747149|O2|Outcome|Rosuvastatin 20 mg (Initial)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
504034|NCT00747149|O1|Outcome|Rosuvastatin 10 mg (Initial)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
504035|NCT00747149|E6|Reported Event|Rosuvastatin 40 mg (Titrated)|20 mg RSV as titrated dose
504036|NCT00747149|E5|Reported Event|Rosuvastatin 20 mg (Titrated)|20 mg RSV as titrated dose
504037|NCT00747149|E4|Reported Event|Rosuvastatin 20 mg (Continued, Non-titrated)|20 mg RSV as continued, non-titrated dose
504038|NCT00747149|E3|Reported Event|Rosuvastatin 20 mg (Initial)|20 mg RSV as initial dose
504039|NCT00747149|E2|Reported Event|Rosuvastatin 10 mg (Continued, Non-titrated)|10 mg RSV as a continued, non-titrated dose
504040|NCT00747149|E1|Reported Event|Rosuvastatin 10 mg (Initial)|10 mg rosuvastatin (RSV) as initial dose
504041|NCT00747214|B3|Baseline|Total|Total of all reporting groups
504042|NCT00747214|B2|Baseline|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
504043|NCT00747214|B1|Baseline|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
The following dose escalation scheme was used:
Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
504044|NCT00747214|P2|Participant Flow|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
504045|NCT00747214|P1|Participant Flow|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
The following dose escalation scheme was used:
Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone)
Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
504046|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
504047|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
The following dose escalation scheme was used:
Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
504048|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
504049|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
The following dose escalation scheme was used:
Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
504050|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
504051|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
The following dose escalation scheme was used:
Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
504052|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
504053|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
The following dose escalation scheme was used:
Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
504054|NCT00747214|E2|Reported Event|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
504055|NCT00747214|E1|Reported Event|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
The following dose escalation scheme was used:
Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) or placebo equivalent Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone) or placebo equivalent"
504056|NCT00747227|B3|Baseline|Total|Total of all reporting groups
504057|NCT00747227|B2|Baseline|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
504058|NCT00747227|B1|Baseline|ZV9003 Intraocular Lens|modified light transmission intraocular lens
504059|NCT00747227|P2|Participant Flow|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
504060|NCT00747227|P1|Participant Flow|ZV9003 Intraocular Lens|modified light transmission intraocular lens
504061|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
504062|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
504063|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
504064|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
504065|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
504066|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
504067|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
504068|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
504069|NCT00747227|E2|Reported Event|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
504070|NCT00747227|E1|Reported Event|ZV9003 Intraocular Lens|modified light transmission intraocular lens
504074|NCT00747344|P4|Participant Flow|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
504075|NCT00747344|P3|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
504076|NCT00747344|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
504077|NCT00747344|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
504078|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
504079|NCT00747344|O1|Outcome|Placebo|
504080|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
504081|NCT00747344|O1|Outcome|Placebo|
504082|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
504083|NCT00747344|O1|Outcome|Placebo|
504084|NCT00747344|E4|Reported Event|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
504085|NCT00747344|E3|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
504086|NCT00747344|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
504087|NCT00747344|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
504088|NCT00747435|B1|Baseline|Original Audiological Criteria|"Inclusion Criteria:
Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.
Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+
Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.
Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
504089|NCT00747435|P1|Participant Flow|Original Audiological Criteria|"Originally the study was designed to have two ARMs, but the second study ARM did not fully enroll. At the time of submission, the data for both ARMs was collapsed and data analysis was completed on all subjects as one group. The below inclusion criteria represents both ARMs as one group.
Inclusion Criteria:
Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.
Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+
Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.
Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
504090|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:
Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.
Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+
Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.
Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
504091|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:
Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.
Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+
Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.
Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
504092|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:
Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.
Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+
Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.
Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
504093|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:
Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.
Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+
Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.
Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
504094|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:
Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.
Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+
Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.
Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
504095|NCT00747435|E1|Reported Event|Original Audiological Criteria|"Inclusion Criteria:
Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.
Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+
Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.
Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
504096|NCT00747461|B1|Baseline|Cryo Spray Ablation|subjects will receive up to 4 -5 second cycles of cryospray ablation
504097|NCT00747461|P1|Participant Flow|Cryo Spray Ablation|subjects receiving up to 4 -5 second spray cycles
504098|NCT00747461|O1|Outcome|Cryo Spray Ablation|subjects receiving cryo spray ablation
504099|NCT00747461|O1|Outcome|Cryo Spray Ablation|Subject receiving cryo spray ablation
504100|NCT00747461|E1|Reported Event|All Subjects Receiving CSA Cryospray|"All subjects enrolled will received CSA cryospray.
CryoSpray Ablation (tm): The CryoSpray Ablation(TM) System is a cryosurgical device utilizing a low-pressure liquid nitrogen spray tip CSATM Catheter. Medical grade liquid nitrogen is the cryogen used in the device. The device is used to destroy unwanted tissue by the application of extreme cold with the focused application to select tissue. The cryogen is stored in a liquid nitrogen holding tank integrated into the system."
504101|NCT00747474|B1|Baseline|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504102|NCT00747474|P12|Participant Flow|Cohort 12 (60 mg/m^2)|Participants received 60 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504103|NCT00747474|P11|Participant Flow|Cohort 11 (50 mg/m^2)|Participants received 50 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504104|NCT00747474|P10|Participant Flow|Cohort 10 (40 mg/m^2)|Participants received 40 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504105|NCT00747474|P9|Participant Flow|Cohort 9 (35 mg/m^2)|Participants received 35 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504106|NCT00747474|P8|Participant Flow|Cohort 8 (40 mg/m^2)|Participants received 40 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504107|NCT00747474|P7|Participant Flow|Cohort 7 (30 mg/m^2)|Participants received 30 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504108|NCT00747474|P6|Participant Flow|Cohort 6 (20 mg/m^2)|Participants received 20 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504109|NCT00747474|P5|Participant Flow|Cohort 5 (13.5 mg/m^2)|Participants received 13.5 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504110|NCT00747474|P4|Participant Flow|Cohort 4 (9 mg/m^2)|Participants received 9 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504111|NCT00747474|P3|Participant Flow|Cohort 3 (6 mg/m^2)|Participants received 6 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504112|NCT00747474|P2|Participant Flow|Cohort 2 (3 mg/m^2)|Participants received 3 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504113|NCT00747474|P1|Participant Flow|Cohort 1 (1.5 mg/m^2)|Participants received 1.5 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
504114|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504115|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504116|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504117|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504118|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504119|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504120|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504121|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504122|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504123|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504124|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504125|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504126|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504127|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504128|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504129|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504130|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504131|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504132|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504133|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504134|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504135|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504136|NCT00747474|O1|Outcome|All Participants|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle according to the dose assigned.
504137|NCT00747474|E1|Reported Event|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504138|NCT00747552|B1|Baseline|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
504139|NCT00747552|P1|Participant Flow|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
504140|NCT00747552|O1|Outcome|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
504141|NCT00747552|O1|Outcome|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
504142|NCT00747552|E1|Reported Event|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
504143|NCT00747565|B3|Baseline|Total|Total of all reporting groups
504144|NCT00747565|B2|Baseline|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
504145|NCT00747565|B1|Baseline|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
504146|NCT00747565|P2|Participant Flow|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
504147|NCT00747565|P1|Participant Flow|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
504148|NCT00747565|O2|Outcome|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
504149|NCT00747565|O1|Outcome|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
504150|NCT00747565|O2|Outcome|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
504151|NCT00747565|O1|Outcome|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
504152|NCT00747565|E2|Reported Event|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
504153|NCT00747565|E1|Reported Event|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints. One additional multifocal subject was enrolled but received an incorrect lens; this subject is included for adverse event reporting for a total of 348 (347 +1) multifocal subjects.
504154|NCT00747617|B3|Baseline|Total|Total of all reporting groups
504155|NCT00747617|B2|Baseline|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
504156|NCT00747617|B1|Baseline|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
504157|NCT00747617|P2|Participant Flow|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
504158|NCT00747617|P1|Participant Flow|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
504159|NCT00747617|O2|Outcome|Normal|Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
504160|NCT00747617|O1|Outcome|PCOS|Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
504161|NCT00747617|E2|Reported Event|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
504162|NCT00747617|E1|Reported Event|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
504163|NCT00747643|B3|Baseline|Total|Total of all reporting groups
504164|NCT00747643|B2|Baseline|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
504165|NCT00747643|B1|Baseline|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
504166|NCT00747643|P2|Participant Flow|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
504167|NCT00747643|P1|Participant Flow|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
504168|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
504169|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
504170|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
504171|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
504172|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
504173|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
504174|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
504175|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
504176|NCT00747643|E2|Reported Event|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
504177|NCT00747643|E1|Reported Event|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
504178|NCT00747747|B4|Baseline|Total|Total of all reporting groups
504179|NCT00747747|B3|Baseline|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning – evening)
504180|NCT00747747|B2|Baseline|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning – evening)
504181|NCT00747747|B1|Baseline|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
504182|NCT00747747|P3|Participant Flow|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning – evening)
504183|NCT00747747|P2|Participant Flow|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning – evening)
504184|NCT00747747|P1|Participant Flow|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
504185|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
504186|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
504187|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
504188|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
504189|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
504190|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
504191|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
504192|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
504193|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
504194|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
504195|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
504196|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
504197|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
504198|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
504199|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
504200|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
504201|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
504202|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
504203|NCT00747747|E3|Reported Event|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
504204|NCT00747747|E2|Reported Event|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
504205|NCT00747747|E1|Reported Event|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
504206|NCT00738283|B1|Baseline|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
504207|NCT00738283|P1|Participant Flow|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
504208|NCT00738283|O1|Outcome|Observational Group|Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
504209|NCT00738283|E1|Reported Event|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
504210|NCT00738361|B1|Baseline|NAb-paclitaxel|Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
504211|NCT00738361|P1|Participant Flow|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
504212|NCT00738361|O1|Outcome|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
504213|NCT00738361|O1|Outcome|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
504214|NCT00738361|O1|Outcome|Nab-paclitaxel|"Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
nab-paclitaxel: 150 mg/m2 weekly for 3 of 4 weeks every 28 days."
504215|NCT00738361|E1|Reported Event|NAb-paclitaxel|Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
504216|NCT00738374|B4|Baseline|Total|Total of all reporting groups
504217|NCT00738374|B3|Baseline|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
504218|NCT00738374|B2|Baseline|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504219|NCT00738374|B1|Baseline|CLB + R: Not Randomized|Participants began a 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants who completed the induction treatment with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
504220|NCT00738374|P4|Participant Flow|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
504264|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
504420|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
504221|NCT00738374|P3|Participant Flow|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504269|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
504929|NCT00748072|E2|Reported Event|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
504222|NCT00738374|P2|Participant Flow|CLB + R: Completed Induction Treament But Not Randomized|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants were not randomized to receive further treatment or observation.
504223|NCT00738374|P1|Participant Flow|Chlorambucil (CLB) Plus (+) Rituximab (R): Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 milligrams per square meter (mg/m^2), orally (PO) as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, intravenously (IV), on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with complete response (CR), complete response with incomplete bone marrow recovery (CRi), or partial response (PR) were randomized to receive either rituximab, 375 mg/m^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
504224|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
504225|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504226|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
504227|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504228|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
504229|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504230|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
504231|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504232|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
504233|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
504234|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
504235|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
504236|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
504237|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
504238|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
504239|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
504240|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504241|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504242|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
504243|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504265|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
504266|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
504244|NCT00738374|O1|Outcome|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8.
504270|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
504245|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
504246|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504247|NCT00738374|O1|Outcome|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8.
504248|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
504249|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504250|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
504251|NCT00738374|E3|Reported Event|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
504252|NCT00738374|E2|Reported Event|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
504253|NCT00738374|E1|Reported Event|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
504254|NCT00738400|B3|Baseline|Total|Total of all reporting groups
504255|NCT00738400|B2|Baseline|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
504256|NCT00738400|B1|Baseline|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
504257|NCT00738400|P2|Participant Flow|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
504258|NCT00738400|P1|Participant Flow|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
504259|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
504260|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
504261|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
504262|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
504263|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
504267|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
504268|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
504930|NCT00748072|E1|Reported Event|Saline Solution|patients treated with 1 ml of s.c. saline solution
504271|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
504272|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
504273|NCT00738400|E2|Reported Event|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
504274|NCT00738400|E1|Reported Event|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
504275|NCT00738426|B3|Baseline|Total|Total of all reporting groups
504276|NCT00738426|B2|Baseline|Sham Device|"non-therapeutic sham light output
Sham device: non-therapeutic light energy output"
504277|NCT00738426|B1|Baseline|Erchonia ML Scanner (MLS)|"Red diode low level laser light energy
Erchonia ML Scanner (MLS): Red diode low level laser light energy."
504278|NCT00738426|P2|Participant Flow|Sham Device|"non-therapeutic sham light output
Sham device: non-therapeutic light energy output"
504279|NCT00738426|P1|Participant Flow|Erchonia ML Scanner (MLS)|"red diode low level laser light energy
Erchonia ML Scanner (MLS): Red diode low level laser light energy."
504280|NCT00738426|O2|Outcome|Sham Device|"non-therapeutic sham light output
Sham device: non-therapeutic light energy output"
504281|NCT00738426|O1|Outcome|Erchonia ML Scanner (MLS)|"Red diode low level laser light energy
Erchonia ML Scanner (MLS): Red diode low level laser light energy."
504282|NCT00738426|E2|Reported Event|Sham Device|"non-therapeutic sham light output
Sham device: non-therapeutic light energy output"
504283|NCT00738426|E1|Reported Event|Erchonia ML Scanner (MLS)|"red diode low level laser light energy
Erchonia ML Scanner (MLS): Red diode low level laser light energy."
504284|NCT00738530|B3|Baseline|Total|Total of all reporting groups
504285|NCT00738530|B2|Baseline|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504286|NCT00738530|B1|Baseline|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504287|NCT00738530|P2|Participant Flow|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504288|NCT00738530|P1|Participant Flow|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) was administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity.
504289|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504290|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504291|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504292|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504293|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504294|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504295|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504296|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504370|NCT00738881|B2|Baseline|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pemetrexed disodium: Given IV"
504297|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504298|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504299|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504300|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504301|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504302|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504303|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504304|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504305|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504306|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504307|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504308|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504309|NCT00738530|E2|Reported Event|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504310|NCT00738530|E1|Reported Event|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
504311|NCT00738543|B1|Baseline|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
504312|NCT00738543|P1|Participant Flow|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
504313|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
504314|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
504315|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
504316|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
504317|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
504318|NCT00738543|E1|Reported Event|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
504319|NCT00738673|B3|Baseline|Total|Total of all reporting groups
504320|NCT00738673|B2|Baseline|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504321|NCT00738673|B1|Baseline|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504322|NCT00738673|P2|Participant Flow|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504371|NCT00738881|B1|Baseline|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally"
504323|NCT00738673|P1|Participant Flow|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504324|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
578588|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
504325|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504326|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504327|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504328|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504329|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504330|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504331|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504332|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504333|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504334|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504335|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504336|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504337|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504338|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504339|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504340|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504341|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504342|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504343|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504344|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504345|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504421|NCT00739050|E2|Reported Event|Placebo|Placebo daily at nights for 12 weeks
504422|NCT00739050|E1|Reported Event|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
504346|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504347|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504348|NCT00738673|E2|Reported Event|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504349|NCT00738673|E1|Reported Event|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
504350|NCT00738699|B3|Baseline|Total|Total of all reporting groups
504351|NCT00738699|B2|Baseline|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504352|NCT00738699|B1|Baseline|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504353|NCT00738699|P2|Participant Flow|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504354|NCT00738699|P1|Participant Flow|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504355|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504356|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504357|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504358|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504372|NCT00738881|P2|Participant Flow|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pemetrexed disodium: Given IV"
504373|NCT00738881|P1|Participant Flow|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally"
504374|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pemetrexed disodium: Given IV"
504862|NCT00740181|B1|Baseline|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
504359|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504360|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504361|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504362|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504363|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504364|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504365|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504366|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504367|NCT00738699|E2|Reported Event|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504368|NCT00738699|E1|Reported Event|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
504369|NCT00738881|B3|Baseline|Total|Total of all reporting groups
504418|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
504375|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally"
504376|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pemetrexed disodium: Given IV"
504377|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally"
504378|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pemetrexed disodium: Given IV"
504379|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally"
504380|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pemetrexed disodium: Given IV"
504381|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally"
504382|NCT00738881|E2|Reported Event|Arm II|pemetrexed disodium: Given IV
504383|NCT00738881|E1|Reported Event|Arm I|erlotinib hydrochloride: Given orally
504384|NCT00738972|B5|Baseline|Total|Total of all reporting groups
504385|NCT00738972|B4|Baseline|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
504386|NCT00738972|B3|Baseline|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
504387|NCT00738972|B2|Baseline|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
504388|NCT00738972|B1|Baseline|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
504389|NCT00738972|P4|Participant Flow|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
504390|NCT00738972|P3|Participant Flow|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
504391|NCT00738972|P2|Participant Flow|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
504392|NCT00738972|P1|Participant Flow|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
504393|NCT00738972|O4|Outcome|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
504394|NCT00738972|O3|Outcome|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
504395|NCT00738972|O2|Outcome|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
504396|NCT00738972|O1|Outcome|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
504397|NCT00738972|E4|Reported Event|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
504398|NCT00738972|E3|Reported Event|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
504399|NCT00738972|E2|Reported Event|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
504400|NCT00738972|E1|Reported Event|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
504401|NCT00739024|B3|Baseline|Total|Total of all reporting groups
504402|NCT00739024|B2|Baseline|Placebo|Random assignment to placebo
504403|NCT00739024|B1|Baseline|Active Treatment|Random assignment to active treatment
504404|NCT00739024|P2|Participant Flow|Placebo|Random assignment to placebo
504405|NCT00739024|P1|Participant Flow|Active Treatment|Random assignment to active treatment
504406|NCT00739024|O2|Outcome|Placebo|Random assignment to placebo
504407|NCT00739024|O1|Outcome|Active Treatment|Random assignment to active treatment
504408|NCT00739024|E2|Reported Event|Placebo|Random assignment to placebo
504409|NCT00739024|E1|Reported Event|Active Treatment|Random assignment to active treatment
504410|NCT00739050|B1|Baseline|All Participants|"All Randomized patients.
Laboratory values were only avaliable for 3 participants for Total Cholesterol, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)"
504411|NCT00739050|P2|Participant Flow|Placebo|Placebo daily at nights for 12 weeks
504412|NCT00739050|P1|Participant Flow|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
504413|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
504414|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
504415|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
504416|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
504417|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
504424|NCT00739063|P1|Participant Flow|Tarceva Daily|Tarceva oral 150 mg daily.
504425|NCT00739063|O1|Outcome|Tarceva Daily|Tarceva oral 150 mg daily.
504426|NCT00739063|E1|Reported Event|Tarceva Daily|Tarceva oral 150 mg daily.
504505|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
504427|NCT00739102|B1|Baseline|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504428|NCT00739102|P1|Participant Flow|S.M.A.R.T.® Nitinol Stent System|The Cordis S.M.A.R.T. ®Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504429|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504430|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504431|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504432|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504433|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504434|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504435|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504436|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504437|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504438|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504439|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504440|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504441|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504442|NCT00739102|E1|Reported Event|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
504443|NCT00739297|B1|Baseline|All Participants|Combined participants from all arms.
504859|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
504506|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
505168|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
504444|NCT00739297|P7|Participant Flow|Total|"Consistent with the incomplete-block design of this study, 6 treatments (placebo and 5 active-dose levels) were administered during only 4 treatment periods. In other words, in this 4-period crossover design, no patient received all 6 treatments and thus some treatments were not
received by all of the patients. Therefore, the TOTAL number of participants across ALL the dose levels provides the best metric to follow the consistency of patient flow from one treatment period to the next treatment period."
504445|NCT00739297|P6|Participant Flow|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504446|NCT00739297|P5|Participant Flow|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504447|NCT00739297|P4|Participant Flow|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504448|NCT00739297|P3|Participant Flow|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504449|NCT00739297|P2|Participant Flow|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504450|NCT00739297|P1|Participant Flow|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504451|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504452|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504453|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504454|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504455|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504456|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504457|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504502|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
504503|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
504458|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504459|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504460|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504461|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504462|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504463|NCT00739297|O2|Outcome|Montelukast+ Placebo|Montelukast (data for each patient are pooled across all 3 of the active doses received by that patient) +Placebo for Albuterol (data for each patient are pooled across all 3 administrations of placebo for albuterol, as added to active montelukast)
504464|NCT00739297|O1|Outcome|Montelukast+Albuterol|Montelukast (data for each patient are pooled across all 3 of the active doses received by that patient) +Albuterol (data for each patient are pooled across all 3 administrations of active albuterol, as added to active montelukast)
504465|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504466|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504467|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504468|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504469|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504470|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504471|NCT00739297|E6|Reported Event|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504472|NCT00739297|E5|Reported Event|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504504|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
504860|NCT00740051|E2|Reported Event|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
504473|NCT00739297|E4|Reported Event|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504474|NCT00739297|E3|Reported Event|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504475|NCT00739297|E2|Reported Event|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504476|NCT00739297|E1|Reported Event|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
504477|NCT00739310|B1|Baseline|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation.
Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
504478|NCT00739310|P1|Participant Flow|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily
Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
504479|NCT00739310|O2|Outcome|Post Vest Treatment|12 months of intervention 2 x daily Vest Therapy
504480|NCT00739310|O1|Outcome|Pre-Treatment|Prior to Vest Treatment
504481|NCT00739310|E1|Reported Event|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily
Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
504482|NCT00739336|B3|Baseline|Total|Total of all reporting groups
504483|NCT00739336|B2|Baseline|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
504484|NCT00739336|B1|Baseline|Intervention|"A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
Diabetes Prevention and Control: The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings."
504485|NCT00739336|P2|Participant Flow|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
504486|NCT00739336|P1|Participant Flow|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
504487|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
504488|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
504489|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
504490|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
504491|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
504492|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
504493|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
504494|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
504495|NCT00739336|E2|Reported Event|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
504496|NCT00739336|E1|Reported Event|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
504497|NCT00739583|B3|Baseline|Total|Total of all reporting groups
504498|NCT00739583|B2|Baseline|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
504499|NCT00739583|B1|Baseline|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
504500|NCT00739583|P2|Participant Flow|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
504501|NCT00739583|P1|Participant Flow|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
504652|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
504507|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
504508|NCT00739583|E2|Reported Event|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
504509|NCT00739583|E1|Reported Event|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
504510|NCT00739596|B3|Baseline|Total|Total of all reporting groups
504511|NCT00739596|B2|Baseline|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
504512|NCT00739596|B1|Baseline|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
504513|NCT00739596|P2|Participant Flow|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
504514|NCT00739596|P1|Participant Flow|Aliskiren Hydrochlorothiazide (HCTZ)|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
504515|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
504516|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
504517|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
504518|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
504519|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
504520|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
504521|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
504522|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
504523|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
504524|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
504525|NCT00739596|E2|Reported Event|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks.
504526|NCT00739596|E1|Reported Event|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks.
504527|NCT00739648|B3|Baseline|Total|Total of all reporting groups
504528|NCT00739648|B2|Baseline|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
504529|NCT00739648|B1|Baseline|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
504530|NCT00739648|P2|Participant Flow|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
504531|NCT00739648|P1|Participant Flow|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
504532|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
504533|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
504534|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
504535|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
504536|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
504537|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
504538|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily (BID)via PARI eFlow nebulizer for 5 consecutive days in each 28-day treatment cycle for up to 12 cycles
504539|NCT00739648|O1|Outcome|Placebo|Placebo inhaled twice daily (BID) via PARI eFlow nebulizer for 5 consecutive days in each 28-day treatment cycle for up to 12 cycles
504540|NCT00739648|E2|Reported Event|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
504541|NCT00739648|E1|Reported Event|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
504542|NCT00739661|B3|Baseline|Total|Total of all reporting groups
504543|NCT00739661|B2|Baseline|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504544|NCT00739661|B1|Baseline|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504545|NCT00739661|P2|Participant Flow|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504653|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
504546|NCT00739661|P1|Participant Flow|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504863|NCT00740181|P1|Participant Flow|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
504547|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504548|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504549|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504550|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504551|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504552|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504553|NCT00739661|E2|Reported Event|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504554|NCT00739661|E1|Reported Event|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
504555|NCT00739674|B3|Baseline|Total|Total of all reporting groups
504556|NCT00739674|B2|Baseline|Diet Management and Losartan-Based Regimen (DML Group)|"Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit)."
504557|NCT00739674|B1|Baseline|Losartan-Based Regimen Alone (L Group)|"Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit)."
504558|NCT00739674|P2|Participant Flow|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt Dietary Approaches to Stop Hypertension (DASH) diet management.
504559|NCT00739674|P1|Participant Flow|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including hydrochlorothiazide (HCTZ) 12.5 mg or 25 mg and calcium channel blocker (CCB) as needed to achieve target blood pressure.
504560|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504561|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504562|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504563|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504564|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504565|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504566|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504567|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504568|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504569|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504570|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504571|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504572|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504922|NCT00748072|B3|Baseline|Total|Total of all reporting groups
504573|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504574|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504575|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504576|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504577|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504578|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504579|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504580|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504581|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504582|NCT00739674|E2|Reported Event|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
504583|NCT00739674|E1|Reported Event|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
504584|NCT00739765|B4|Baseline|Total|Total of all reporting groups
504585|NCT00739765|B3|Baseline|3 Relaxation Therapy|"Participants will receive relaxation therapy.
Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
504586|NCT00739765|B2|Baseline|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.
Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
504587|NCT00739765|B1|Baseline|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.
Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
504588|NCT00739765|P3|Participant Flow|3 Relaxation Therapy|"Participants will receive relaxation therapy.
Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
504589|NCT00739765|P2|Participant Flow|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.
Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
504590|NCT00739765|P1|Participant Flow|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.
Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
504591|NCT00739765|O3|Outcome|3 Relaxation Therapy|"Participants will receive relaxation therapy.
Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
504592|NCT00739765|O2|Outcome|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.
Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
504593|NCT00739765|O1|Outcome|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.
Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
504594|NCT00739765|O3|Outcome|3 Relaxation Therapy|"Participants will receive relaxation therapy.
Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
504595|NCT00739765|O2|Outcome|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.
Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
504596|NCT00739765|O1|Outcome|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.
Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
504597|NCT00739765|E3|Reported Event|3 Relaxation Therapy|"Participants will receive relaxation therapy.
Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
504654|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
504655|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
504598|NCT00739765|E2|Reported Event|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.
Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
504599|NCT00739765|E1|Reported Event|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.
Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
504600|NCT00739882|B3|Baseline|Total|Total of all reporting groups
504601|NCT00739882|B2|Baseline|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
504602|NCT00739882|B1|Baseline|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
504603|NCT00739882|P2|Participant Flow|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
504604|NCT00739882|P1|Participant Flow|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
504605|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
504606|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
504607|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
504608|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
504609|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
504610|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
504611|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
504612|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
504613|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
504614|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
504615|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
504616|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
504617|NCT00739882|E4|Reported Event|Placebo - Open-label Period|
504618|NCT00739882|E3|Reported Event|Efalizumab - Open-label Period|
504619|NCT00739882|E2|Reported Event|Placebo - Double-blind Period|
504620|NCT00739882|E1|Reported Event|Efalizumab - Double-blind Period|
504621|NCT00739908|B3|Baseline|Total|Total of all reporting groups
504622|NCT00739908|B2|Baseline|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
504623|NCT00739908|B1|Baseline|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
504624|NCT00739908|P2|Participant Flow|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
504625|NCT00739908|P1|Participant Flow|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
504626|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
504627|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
504628|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
504629|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
504630|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
504631|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
504632|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
504633|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
504634|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
504635|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
504636|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
504637|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
504638|NCT00739908|O2|Outcome|Oral Placebo TID|No active medication, the same as a Sugar Pill
504639|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational Reversible Monoamine Oxidase Inhibitor (MAOI)
504640|NCT00739908|E2|Reported Event|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
504641|NCT00739908|E1|Reported Event|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
504642|NCT00739934|B1|Baseline|All Participants|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
504643|NCT00739934|P1|Participant Flow|All Participants|Voriconazole intravenous (IV) multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
504644|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
504645|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
504646|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
504647|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
504648|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
504649|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
504650|NCT00739934|O1|Outcome|All Treatments|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
504651|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
504656|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
504657|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
504658|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
504659|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
504660|NCT00739934|E2|Reported Event|Voriconazole Oral|Voriconazole oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
504661|NCT00739934|E1|Reported Event|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
504662|NCT00739973|B10|Baseline|Total|Total of all reporting groups
504663|NCT00739973|B9|Baseline|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504664|NCT00739973|B8|Baseline|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504665|NCT00739973|B7|Baseline|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504666|NCT00739973|B6|Baseline|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504667|NCT00739973|B5|Baseline|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
504668|NCT00739973|B4|Baseline|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504669|NCT00739973|B3|Baseline|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504670|NCT00739973|B2|Baseline|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504671|NCT00739973|B1|Baseline|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504672|NCT00739973|P9|Participant Flow|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504673|NCT00739973|P8|Participant Flow|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504689|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504813|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504674|NCT00739973|P7|Participant Flow|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504675|NCT00739973|P6|Participant Flow|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504676|NCT00739973|P5|Participant Flow|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
504677|NCT00739973|P4|Participant Flow|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504678|NCT00739973|P3|Participant Flow|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504679|NCT00739973|P2|Participant Flow|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504680|NCT00739973|P1|Participant Flow|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504681|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504682|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504683|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504684|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504685|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
504686|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504687|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504688|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504767|NCT00739999|B1|Baseline|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504690|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504691|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504692|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504693|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504694|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
504695|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504696|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504697|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504698|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504699|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504700|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504701|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504702|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504703|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
504704|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504811|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504705|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504706|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504707|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504708|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504709|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504710|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504711|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
504712|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504713|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504714|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504715|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504716|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504717|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504718|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504719|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504768|NCT00739999|P2|Participant Flow|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Age 10 - 17 years, at Tanner Stage 2+. Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained.
504812|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504720|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504721|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504722|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504723|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
504724|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504725|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504726|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504727|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
504728|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504729|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504730|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504731|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504732|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504733|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504734|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504857|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
504735|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504736|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504737|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504738|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504739|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
504740|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504741|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504742|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504743|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504744|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504745|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504746|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504747|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504748|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504749|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504769|NCT00739999|P1|Participant Flow|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Age 6 - 10 years, at Tanner Stage 1. Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target low-density lipoprotein cholesterol (LDL-C) was not attained.
504750|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504751|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504752|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504753|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504754|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504755|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504756|NCT00739973|E9|Reported Event|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504757|NCT00739973|E8|Reported Event|Aliskiren/Amlodipine 300/5 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504758|NCT00739973|E7|Reported Event|Aliskiren/Amlodipine 150/10 mg Tablet|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504759|NCT00739973|E6|Reported Event|Aliskiren/Amlodipine 150/5 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504760|NCT00739973|E5|Reported Event|Amlodipine 10 mg Capsule|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
504761|NCT00739973|E4|Reported Event|Amlodipine 5 mg Capsule|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504762|NCT00739973|E3|Reported Event|Aliskiren 300 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504763|NCT00739973|E2|Reported Event|Aliskiren 150 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
504764|NCT00739973|E1|Reported Event|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
504765|NCT00739999|B3|Baseline|Total|Total of all reporting groups
504766|NCT00739999|B2|Baseline|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504770|NCT00739999|O1|Outcome|Atorvastatin (5 mg, 10 mg, 20 mg): Tanner Stages 1 and 2+|Tanner Stage 1: Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated; Tanner Stage 2+: Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504771|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504772|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504773|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504774|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504775|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504776|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504777|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504778|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504779|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504780|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504781|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504782|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504783|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504784|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504785|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504786|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504787|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504788|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504789|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504790|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504791|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504792|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504793|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504794|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504795|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504796|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504797|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504798|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504799|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504800|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504801|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504802|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504803|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504804|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504805|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504806|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504807|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504808|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504809|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504810|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504858|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
508197|NCT00757666|O1|Outcome|Accelerometer|Accelerometer
504815|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504816|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504817|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504818|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504819|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504820|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504821|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504822|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504823|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504824|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504825|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504826|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504827|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504828|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504829|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504830|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504831|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504832|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
504833|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504834|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
504835|NCT00739999|O2|Outcome|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
504836|NCT00739999|O1|Outcome|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504837|NCT00739999|E2|Reported Event|All Subjects (10 mg, 20 mg): Tanner Stage 2+|Atorvastatin: subjects who stayed at initial dose of 10 mg/day for duration of study and subjects who titrated to 20 mg/day after Week 4 if target LDL-C was not attained and study drug was well tolerated.
504838|NCT00739999|E1|Reported Event|All Subjects (5 mg, 10 mg): Tanner Stage 1|Atorvastatin: subjects who stayed at initial dose of 5 mg/day for duration of study and subjects who titrated after Week 4 to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
504839|NCT00740051|B3|Baseline|Total|Total of all reporting groups
504840|NCT00740051|B2|Baseline|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
504841|NCT00740051|B1|Baseline|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
504842|NCT00740051|P2|Participant Flow|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
504843|NCT00740051|P1|Participant Flow|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
504844|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
504845|NCT00740051|O1|Outcome|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
504846|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
504847|NCT00740051|O1|Outcome|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
504848|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
504849|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
504850|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
504851|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
504852|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
504853|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
504854|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
504855|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
504856|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
508198|NCT00757666|O2|Outcome|Minute Ventilation|Minute ventilation
504861|NCT00740051|E1|Reported Event|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
504885|NCT00740480|B1|Baseline|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
504864|NCT00740181|O1|Outcome|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
504865|NCT00740181|E1|Reported Event|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
504866|NCT00740207|B3|Baseline|Total|Total of all reporting groups
504867|NCT00740207|B2|Baseline|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504868|NCT00740207|B1|Baseline|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504869|NCT00740207|P2|Participant Flow|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504870|NCT00740207|P1|Participant Flow|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504871|NCT00740207|O2|Outcome|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504872|NCT00740207|O1|Outcome|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504873|NCT00740207|O2|Outcome|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504874|NCT00740207|O1|Outcome|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504875|NCT00740207|O4|Outcome|VAS Score After Injection of VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504876|NCT00740207|O3|Outcome|VAS Score Prior to Injection of VISIPAQUE 270|Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10.
504877|NCT00740207|O2|Outcome|VAS Score After Injection of ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504878|NCT00740207|O1|Outcome|VAS Score Prior to Injection of ISOVUE 250|Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10.
504879|NCT00740207|E2|Reported Event|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504880|NCT00740207|E1|Reported Event|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
504881|NCT00740220|B1|Baseline|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
504882|NCT00740220|P1|Participant Flow|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
504883|NCT00740220|O1|Outcome|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
504884|NCT00740220|E1|Reported Event|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
504886|NCT00740480|P1|Participant Flow|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
504887|NCT00740480|O1|Outcome|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
504888|NCT00740480|O1|Outcome|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
504889|NCT00740584|B1|Baseline|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
504890|NCT00740584|P1|Participant Flow|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
504891|NCT00740584|O1|Outcome|Open Label Active|
504892|NCT00740584|E1|Reported Event|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
504893|NCT00740597|B1|Baseline|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
504894|NCT00740597|P1|Participant Flow|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
504895|NCT00740597|O1|Outcome|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
504896|NCT00740597|E1|Reported Event|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
504897|NCT00740636|B3|Baseline|Total|Total of all reporting groups
504898|NCT00740636|B2|Baseline|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
504899|NCT00740636|B1|Baseline|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
504900|NCT00740636|P2|Participant Flow|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
504901|NCT00740636|P1|Participant Flow|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
504902|NCT00740636|O2|Outcome|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
504903|NCT00740636|O1|Outcome|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
504904|NCT00740636|E2|Reported Event|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
504905|NCT00740636|E1|Reported Event|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
504906|NCT00747812|B3|Baseline|Total|Total of all reporting groups
504907|NCT00747812|B2|Baseline|Sham Stimulation (Control Group)|Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
504908|NCT00747812|B1|Baseline|Active Stimulation (Treatment Group)|Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
504909|NCT00747812|P2|Participant Flow|Sham Stimulation (Control Group)|Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
504910|NCT00747812|P1|Participant Flow|Active Stimulation (Treatment Group)|Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
504911|NCT00747812|O2|Outcome|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
504912|NCT00747812|O1|Outcome|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
504913|NCT00747812|O2|Outcome|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
504914|NCT00747812|O1|Outcome|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
504915|NCT00747812|E2|Reported Event|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
504916|NCT00747812|E1|Reported Event|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
504917|NCT00747916|B1|Baseline|All Participants ICE PLS|
504918|NCT00747916|P1|Participant Flow|All Participants ICE PLS|The study consists of one arm. All subjects enrolled in All participants ICE PLS
504919|NCT00747916|O1|Outcome|All Participants ICE PLS|
504920|NCT00747916|O1|Outcome|All Participants ICE PLS|
504921|NCT00747916|E1|Reported Event|All Participants ICE PLS|
504923|NCT00748072|B2|Baseline|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
504924|NCT00748072|B1|Baseline|Saline Solution|patients treated with 1 ml of s.c. saline solution
504925|NCT00748072|P2|Participant Flow|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
504926|NCT00748072|P1|Participant Flow|Saline Solution|patients treated with 1 ml of s.c. saline solution
504927|NCT00748072|O2|Outcome|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
504931|NCT00748085|B1|Baseline|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
504932|NCT00748085|P1|Participant Flow|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
504933|NCT00748085|O1|Outcome|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
504934|NCT00748085|O1|Outcome|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
504935|NCT00748085|E1|Reported Event|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
504936|NCT00748098|B1|Baseline|All Participants in the Intent-to-Treat (ITT) Population|All randomized participants who took at least one dose of study drug and had at least one post-baseline polysomnography (PSG) efficacy assessment
504937|NCT00748098|P2|Participant Flow|GEn 1200 mg/Day Followed by Placebo|Participants randomized to GEn 1200 mg/day administered once daily with food at 5 pm during the 28-day First Treatment Intervention Period (Days 1-3, 600 mg). GEn 600 mg administered once daily with food at 5 pm during the 7-day First Taper Period. No treatment was given during 7-day Washout. Matching placebo administered once daily with food at 5 pm during the 28-day Second Treatment Intervention Period and the 7-day Second Taper Period. No treatment was given during Follow-up.
504938|NCT00748098|P1|Participant Flow|Placebo Followed by GEn 1200 mg/Day|Participants randomized to matching placebo administered once daily with food at 5 pm during the 28-day First Treatment Intervention Period and the 7-day First Taper Period. No treatment was given during the 7-day Washout. Gabapentin enacarbil (GEn) 1200 mg/day administered once daily with food at 5 pm during the 28-day Second Treatment Intervention Period (Days 1-3, 600 mg). GEn 600 mg administered once daily with food at 5 pm during the 7-day Second Taper Period. No treatment was given during Follow-up.
504939|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504940|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504941|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504942|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
504943|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504944|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504945|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504946|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504947|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504948|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
504949|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504950|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504951|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504952|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504953|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504954|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504955|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504956|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504957|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504958|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504959|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504960|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504961|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504962|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504963|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504964|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504965|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504966|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504967|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504968|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
504969|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504970|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504971|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504972|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504973|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504974|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504975|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504976|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504977|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504978|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504979|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504980|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504981|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504982|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504983|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504984|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504985|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504986|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504987|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504988|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504989|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504990|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504991|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504992|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504993|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504994|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504995|NCT00748098|E2|Reported Event|GEn 1200 mg|Participants who took at least one dose of GEn 1200 mg in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 127 took at least one dose of GEn 1200 mg.
504996|NCT00748098|E1|Reported Event|Placebo|Participants who took at least one dose of placebo in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 132 took at least one dose of placebo.
508199|NCT00757666|O1|Outcome|Accelerometer|Accelerometer
504997|NCT00748826|B1|Baseline|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
505035|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY
Low dose NPY: 50nmol, administered intranasally"
505036|NCT00748956|E3|Reported Event|Placebo|"Placebo comparator
Placebo: placebo comparator (0nmol)) administered intranasally"
505037|NCT00748956|E2|Reported Event|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY
High dose NPY: 100nmol administered intranasally"
504998|NCT00748826|P1|Participant Flow|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
504999|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
505000|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
505001|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
505002|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
505003|NCT00748826|E1|Reported Event|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
505004|NCT00748865|B1|Baseline|Overall Study|
505005|NCT00748865|P2|Participant Flow|Systane Drops, Then Systane Ultra Drops|Patients first received Systane Drops, then received Systane Ultra Drops
505006|NCT00748865|P1|Participant Flow|Systane Ultra Drops, Then Systane Drops|Patients received Systane Ultra Drops first, then received Systane Drops.
505007|NCT00748865|O2|Outcome|Systane|Systane
505008|NCT00748865|O1|Outcome|Systane Ultra|Systane Ultra
505009|NCT00748865|E2|Reported Event|Systane|Systane
505010|NCT00748865|E1|Reported Event|Systane Ultra|Systane Ultra
505011|NCT00748956|B4|Baseline|Total|Total of all reporting groups
505012|NCT00748956|B3|Baseline|Placebo|"Placebo comparator
Placebo: placebo comparator (0nmol)) administered intranasally"
505013|NCT00748956|B2|Baseline|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY
High dose NPY: 100nmol administered intranasally"
505014|NCT00748956|B1|Baseline|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY
Low dose NPY: 50nmol, administered intranasally"
505015|NCT00748956|P3|Participant Flow|Placebo|"Placebo comparator
Placebo: placebo comparator (0nmol)) administered intranasally"
505016|NCT00748956|P2|Participant Flow|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY
High dose NPY: 100nmol administered intranasally"
505017|NCT00748956|P1|Participant Flow|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY
Low dose NPY: 50nmol, administered intranasally"
505018|NCT00748956|O3|Outcome|Placebo|"Placebo comparator
Placebo: placebo comparator (0nmol)) administered intranasally"
505019|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY
High dose NPY: 100nmol administered intranasally"
505020|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY
Low dose NPY: 50nmol, administered intranasally"
505021|NCT00748956|O3|Outcome|Placebo|"Placebo comparator
Placebo: placebo comparator (0nmol)) administered intranasally"
505022|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY
High dose NPY: 100nmol administered intranasally"
505023|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY
Low dose NPY: 50nmol, administered intranasally"
505024|NCT00748956|O3|Outcome|Placebo|"Placebo comparator
Placebo: placebo comparator (0nmol)) administered intranasally"
505025|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY
High dose NPY: 100nmol administered intranasally"
505026|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY
Low dose NPY: 50nmol, administered intranasally"
505027|NCT00748956|O3|Outcome|Placebo|"Placebo comparator
Placebo: placebo comparator (0nmol)) administered intranasally"
505028|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY
High dose NPY: 100nmol administered intranasally"
505029|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY
Low dose NPY: 50nmol, administered intranasally"
505030|NCT00748956|O3|Outcome|Placebo|"Placebo comparator
Placebo: placebo comparator (0nmol)) administered intranasally"
505031|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY
High dose NPY: 100nmol administered intranasally"
505160|NCT00749268|B4|Baseline|Ventral Arm - ProTack|Ventral hernia study arm with ProTack as treatment.
505032|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY
Low dose NPY: 50nmol, administered intranasally"
505033|NCT00748956|O3|Outcome|Placebo|"Placebo comparator
Placebo: placebo comparator (0nmol)) administered intranasally"
505034|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY
High dose NPY: 100nmol administered intranasally"
578589|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
505038|NCT00748956|E1|Reported Event|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY
Low dose NPY: 50nmol, administered intranasally"
505039|NCT00748969|B3|Baseline|Total|Total of all reporting groups
505040|NCT00748969|B2|Baseline|No Growth Hormone Treatment in Year 1|No growth hormone treatment in year 1; option for treatment in year 2 open-label period.
505041|NCT00748969|B1|Baseline|Growth Hormone Treatmen|"Growth hormone treatment arm. Somatropin (DNA origin)
Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
505042|NCT00748969|P2|Participant Flow|No Growth Hormone Treatment in Year 1|No growth hormone treatment in year 1; option for treatment in year 2 open-label period.
505043|NCT00748969|P1|Participant Flow|Growth Hormone Treatmen|"Growth hormone treatment arm. Somatropin (DNA origin)
Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
505044|NCT00748969|O2|Outcome|No Growth Hormone Treatment|Observation only: no growth hormone treatment and no placebo.
505045|NCT00748969|O1|Outcome|Growth Hormone Treatment|"Growth hormone treatment arm. Somatropin (DNA origin)
Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
505046|NCT00748969|E2|Reported Event|No GH Treatment|No placebo/no treatment
505047|NCT00748969|E1|Reported Event|GH Treatment|"Growth hormone treatment arm. Somatropin (DNA origin)
Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
505048|NCT00748982|B3|Baseline|Total|Total of all reporting groups
505049|NCT00748982|B2|Baseline|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
505050|NCT00748982|B1|Baseline|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
505051|NCT00748982|P2|Participant Flow|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
505052|NCT00748982|P1|Participant Flow|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
505053|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
505054|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
505055|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
505056|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
505057|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
505058|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
505059|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
505060|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
505061|NCT00748982|E2|Reported Event|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
505109|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505110|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
505062|NCT00748982|E1|Reported Event|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
505063|NCT00749073|B1|Baseline|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
505064|NCT00749073|P1|Participant Flow|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
505065|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
505066|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression. The mean change and standard deviation between baseline (pretreatment) and Month 6 are reported, where a positive value represents the baseline value minus the 6 month value.
505067|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
505068|NCT00749073|E1|Reported Event|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
505069|NCT00749190|B8|Baseline|Total|Total of all reporting groups
505070|NCT00749190|B7|Baseline|Sitag|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
505071|NCT00749190|B6|Baseline|Empa 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505072|NCT00749190|B5|Baseline|Empa 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505073|NCT00749190|B4|Baseline|Empa 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505074|NCT00749190|B3|Baseline|Empa 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505075|NCT00749190|B2|Baseline|Empa 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505076|NCT00749190|B1|Baseline|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505077|NCT00749190|P7|Participant Flow|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
505078|NCT00749190|P6|Participant Flow|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505079|NCT00749190|P5|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505080|NCT00749190|P4|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505081|NCT00749190|P3|Participant Flow|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505082|NCT00749190|P2|Participant Flow|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505083|NCT00749190|P1|Participant Flow|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505084|NCT00749190|O5|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505085|NCT00749190|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505086|NCT00749190|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505087|NCT00749190|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505088|NCT00749190|O1|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505089|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
505090|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505091|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505092|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505093|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505094|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505095|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505096|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
505097|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505098|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505099|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505100|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505101|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505102|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505103|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
508200|NCT00757666|O2|Outcome|Minute Ventilation|Minute ventilation
505104|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505105|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505106|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505107|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505108|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505111|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505112|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505113|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505114|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505115|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505116|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505117|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
505118|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505119|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505120|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505121|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505122|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505123|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505124|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
505125|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505126|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505127|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505128|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505129|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505130|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505131|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
505132|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505133|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505134|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505135|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505136|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505137|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505138|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
505139|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505140|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505141|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505142|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505143|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505144|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505145|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
505146|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505147|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505148|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505149|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505150|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505151|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505152|NCT00749190|E7|Reported Event|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
505153|NCT00749190|E6|Reported Event|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
505154|NCT00749190|E5|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
505155|NCT00749190|E4|Reported Event|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
505156|NCT00749190|E3|Reported Event|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
505157|NCT00749190|E2|Reported Event|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
505158|NCT00749190|E1|Reported Event|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
505159|NCT00749268|B5|Baseline|Total|Total of all reporting groups
505161|NCT00749268|B3|Baseline|Ventral Arm - Absorbatack|Ventral hernia study arm with AbsorbaTack as treatment.
505162|NCT00749268|B2|Baseline|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
505163|NCT00749268|B1|Baseline|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
505164|NCT00749268|P2|Participant Flow|Ventral Arm|Patients with ventral hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.
505165|NCT00749268|P1|Participant Flow|Inguinal Arm|Patients with inguinal hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.
505166|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
505167|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
505169|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
505170|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
505171|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
505172|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
505173|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
505174|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
505175|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
505176|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
505177|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
505178|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
505179|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
505180|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
505181|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
505182|NCT00749268|E4|Reported Event|Ventral Arm - ProTack|Ventral hernia study arm with ProTack as treatment.
505183|NCT00749268|E3|Reported Event|Ventral Arm - Absorbatack|Ventral hernia study arm with AbsorbaTack as treatment.
505184|NCT00749268|E2|Reported Event|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
505185|NCT00749268|E1|Reported Event|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
505186|NCT00749398|B1|Baseline|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505187|NCT00749398|P1|Participant Flow|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505188|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505189|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505190|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505191|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505192|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505193|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505194|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505195|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505196|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505197|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505198|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505199|NCT00749398|E1|Reported Event|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
505200|NCT00749463|B4|Baseline|Total|Total of all reporting groups
505201|NCT00749463|B3|Baseline|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
505202|NCT00749463|B2|Baseline|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
505203|NCT00749463|B1|Baseline|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
505204|NCT00749463|P3|Participant Flow|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
505205|NCT00749463|P2|Participant Flow|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
505206|NCT00749463|P1|Participant Flow|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
505207|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
505208|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
505209|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
508201|NCT00757666|O1|Outcome|Accelerometer|Accelerometer
505210|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
505211|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
505212|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
505213|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
505214|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
505215|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
505216|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
505217|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
505218|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
505219|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
505220|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
505221|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
505222|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
505223|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
505224|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
505225|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
505226|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
505227|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
505228|NCT00749463|E3|Reported Event|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
505229|NCT00749463|E2|Reported Event|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
505230|NCT00749463|E1|Reported Event|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
505231|NCT00749476|B1|Baseline|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
505232|NCT00749476|P1|Participant Flow|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
505233|NCT00749476|O1|Outcome|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
505234|NCT00749476|E1|Reported Event|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
505235|NCT00749580|B3|Baseline|Total|Total of all reporting groups
505236|NCT00749580|B2|Baseline|2: Boosted PI+NRTIs|Group 2 Continue the same regimen without change
505237|NCT00749580|B1|Baseline|1: Boosted PI+RAL|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
505238|NCT00749580|P2|Participant Flow|Controlled|Group 2 Continue the same regimen without change
505239|NCT00749580|P1|Participant Flow|Switched|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
505240|NCT00749580|O2|Outcome|Boosted PI+NRTIs|Continue the same regimen without change
505241|NCT00749580|O1|Outcome|Boosted PI+RAL|Switch NRTI backbone to RAL
505242|NCT00749580|O2|Outcome|Boosted PI+NRTIs|Continue the same regimen without change
505243|NCT00749580|O1|Outcome|Boosted PI+RAL|Switch NRTI backbone to RAL
505244|NCT00749580|E2|Reported Event|Controlled|Group 2 Continue the same regimen without change
505245|NCT00749580|E1|Reported Event|Switched|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
505246|NCT00749671|B3|Baseline|Total|Total of all reporting groups
505247|NCT00749671|B2|Baseline|Nurse Administered Moderate Sedation|Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient
505248|NCT00749671|B1|Baseline|ICD Testingwith Bispectral Monitoring|"Bispectral Index Monitoring
Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
505249|NCT00749671|P2|Participant Flow|Ramsey Scale Monitoring|Group assigned to sedation monitoring using the Ramsey Scale for ICD testing
505250|NCT00749671|P1|Participant Flow|Bispectral Index Monitoring|Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate.
505251|NCT00749671|O2|Outcome|ICD Testing Ramsey|"Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT
Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale."
505252|NCT00749671|O1|Outcome|ICD Testing BIS|"Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT.
Bispectral index monitoring: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
505253|NCT00749671|O2|Outcome|ICD testing2|"Ramsey Sedation Scale
Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale."
505254|NCT00749671|O1|Outcome|ICD Testing|"Bispectral Index Monitoring
Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
505255|NCT00749671|E2|Reported Event|Nurse Administered Moderate Sedation|Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient
505256|NCT00749671|E1|Reported Event|ICD Testingwith Bispectral Monitoring|"Bispectral Index Monitoring
Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
505257|NCT00749684|B1|Baseline|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:
II and III (>/= 1.5 mm Breslow thickness without distant metastases
melanoma with lymph node metastases"
505258|NCT00749684|P1|Participant Flow|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:
II and III (>/= 1.5 mm Breslow thickness without distant metastases
melanoma with lymph node metastases"
505259|NCT00749684|O1|Outcome|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:
II and III (>/= 1.5 mm Breslow thickness without distant metastases
melanoma with lymph node metastases"
505260|NCT00749684|O1|Outcome|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:
II and III (>/= 1.5 mm Breslow thickness without distant metastases
melanoma with lymph node metastases"
505261|NCT00749684|E1|Reported Event|Interferon Alfa-2b|
505262|NCT00749775|B1|Baseline|Selara|Participants taking Selara according to Japanese Package Insert.
505263|NCT00749775|P1|Participant Flow|Selara|Participants taking Selara according to Japanese Package Insert.
505264|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
505265|NCT00749775|O5|Outcome|At Last Evaluation Date|Mean diastolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
578590|NCT00939094|E2|Reported Event|2 - Placebo|Placebo, capsule
505266|NCT00749775|O4|Outcome|At 12 Weeks|Mean diastolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
505267|NCT00749775|O3|Outcome|At 8 Weeks|Mean diastolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
505268|NCT00749775|O2|Outcome|At 4 Weeks|Mean diastolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
505269|NCT00749775|O1|Outcome|At Baseline|Mean diastolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
505270|NCT00749775|O5|Outcome|At Last Evaluation Date|Mean systolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
505271|NCT00749775|O4|Outcome|At 12 Weeks|Mean systolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
505272|NCT00749775|O3|Outcome|At 8 Weeks|Mean systolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
505273|NCT00749775|O2|Outcome|At 4 Weeks|Mean systolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
505274|NCT00749775|O1|Outcome|At Baseline|Mean systolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
505275|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
505276|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
505277|NCT00749775|E1|Reported Event|Selara|Participants taking Selara according to Japanese Package Insert.
505278|NCT00749931|B3|Baseline|Total|Total of all reporting groups
505279|NCT00749931|B2|Baseline|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.
MarginProbe: Device use to assess margin status of the excised specimen surface.
Lumpectomy: Standard of care lumpectomy procedure"
505280|NCT00749931|B1|Baseline|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure
Lumpectomy: Standard of care lumpectomy procedure"
505281|NCT00749931|P3|Participant Flow|Roll-in|"Use of the device in addition to the standard of care lumpectomy procedure.
MarginProbe: Device use to assess margin status of the excised specimen surface.
Lumpectomy: Standard of care lumpectomy procedure"
505282|NCT00749931|P2|Participant Flow|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.
MarginProbe: Device use to assess margin status of the excised specimen surface.
Lumpectomy: Standard of care lumpectomy procedure"
505283|NCT00749931|P1|Participant Flow|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure
Lumpectomy: Standard of care lumpectomy procedure"
505284|NCT00749931|O2|Outcome|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.
MarginProbe: Device use to assess margin status of the excised specimen surface.
Lumpectomy: Standard of care lumpectomy procedure"
505285|NCT00749931|O1|Outcome|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure
Lumpectomy: Standard of care lumpectomy procedure"
505286|NCT00749931|O2|Outcome|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.
MarginProbe: Device use to assess margin status of the excised specimen surface.
Lumpectomy: Standard of care lumpectomy procedure"
505287|NCT00749931|O1|Outcome|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure
Lumpectomy: Standard of care lumpectomy procedure"
505288|NCT00749931|E3|Reported Event|Roll-in|"Use of the device in addition to the standard of care lumpectomy procedure.
MarginProbe: Device use to assess margin status of the excised specimen surface.
Lumpectomy: Standard of care lumpectomy procedure"
505289|NCT00749931|E2|Reported Event|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.
MarginProbe: Device use to assess margin status of the excised specimen surface.
Lumpectomy: Standard of care lumpectomy procedure"
505290|NCT00749931|E1|Reported Event|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure
Lumpectomy: Standard of care lumpectomy procedure"
505291|NCT00749944|B3|Baseline|Total|Total of all reporting groups
505292|NCT00749944|B2|Baseline|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505293|NCT00749944|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505294|NCT00749944|P2|Participant Flow|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505295|NCT00749944|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505296|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505473|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy
SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
505612|NCT00750373|E1|Reported Event|Conventional|Conventional Treatment based on current guidelines
505297|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505298|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505299|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505300|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505890|NCT00738062|P1|Participant Flow|Open-Label Droxidopa|3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
505301|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505302|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505303|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505304|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505305|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505306|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505307|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505308|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505309|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505310|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505311|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505312|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505313|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505314|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505315|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505316|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505317|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505318|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505319|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505320|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505321|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505322|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505323|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505324|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505325|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505326|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505613|NCT00750737|B3|Baseline|Total|Total of all reporting groups
505327|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505328|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505329|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505330|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505331|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505332|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505333|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505334|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505335|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505336|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505337|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505338|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505339|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505340|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505341|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505342|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505343|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505344|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505345|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505346|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505347|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505348|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505349|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505350|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505351|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505352|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505353|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505354|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505355|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505356|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
508459|NCT00758459|O2|Outcome|Placebo|Placebo
505357|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505358|NCT00749944|E2|Reported Event|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
505359|NCT00749944|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
505360|NCT00749957|B3|Baseline|Total|Total of all reporting groups
507293|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
505361|NCT00749957|B2|Baseline|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505362|NCT00749957|B1|Baseline|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505363|NCT00749957|P2|Participant Flow|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505364|NCT00749957|P1|Participant Flow|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505365|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505366|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505367|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505368|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505369|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505370|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505371|NCT00749957|E2|Reported Event|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505372|NCT00749957|E1|Reported Event|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
505373|NCT00749996|B3|Baseline|Total|Total of all reporting groups
505374|NCT00749996|B2|Baseline|Control Group|"Single level herniectomy
Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
505375|NCT00749996|B1|Baseline|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
505376|NCT00749996|P2|Participant Flow|Control Group|"Single level herniectomy
Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
505377|NCT00749996|P1|Participant Flow|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
505378|NCT00749996|O2|Outcome|Control Group|"Single level herniectomy
Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
505379|NCT00749996|O1|Outcome|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
505380|NCT00749996|O2|Outcome|Control Group|"Single level herniectomy
Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
505381|NCT00749996|O1|Outcome|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
505382|NCT00749996|E2|Reported Event|Control Group|"Single level herniectomy
Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
505383|NCT00749996|E1|Reported Event|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
505384|NCT00750061|B3|Baseline|Total|Total of all reporting groups
505385|NCT00750061|B2|Baseline|Lithium Carbonate|"Lithium Carbonate
Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.
The course of medication is 6 weeks."
505386|NCT00750061|B1|Baseline|Placebo|"Placebo
Placebo: Matching placebo"
505387|NCT00750061|P2|Participant Flow|Lithium Carbonate Tablet|"Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.
The course of medication is 6 weeks."
505388|NCT00750061|P1|Participant Flow|Placebo|Placebo: Matching placebo
505389|NCT00750061|O2|Outcome|Lithium Carbonate|"Lithium Carbonate
Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.
The course of medication is 6 weeks."
505390|NCT00750061|O1|Outcome|Placebo|"Placebo
Placebo: Matching placebo"
505476|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
505477|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy
SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
505391|NCT00750061|O2|Outcome|Lithium Carbonate|"Lithium Carbonate
Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.
The course of medication is 6 weeks."
505392|NCT00750061|O1|Outcome|Placebo|"Placebo
Placebo: Matching placebo"
505393|NCT00750061|E2|Reported Event|Lithium Carbonate Tablet|"Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.
The course of medication is 6 weeks."
505394|NCT00750061|E1|Reported Event|Placebo|Placebo: Matching placebo
505395|NCT00750139|B5|Baseline|Total|Total of all reporting groups
505396|NCT00750139|B4|Baseline|Placebo 4-wks|Placebo cream applied daily for 4 weeks
505397|NCT00750139|B3|Baseline|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
505398|NCT00750139|B2|Baseline|Placebo 2-wks|Placebo applied daily for 2-weeks
505399|NCT00750139|B1|Baseline|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
505400|NCT00750139|P4|Participant Flow|Placebo 4-wks|Placebo cream applied daily for 4 weeks
505401|NCT00750139|P3|Participant Flow|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
505402|NCT00750139|P2|Participant Flow|Placebo 2-wks|Placebo applied daily for 2-weeks
505403|NCT00750139|P1|Participant Flow|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
505404|NCT00750139|O4|Outcome|Placebo 4-wks|Placebo cream applied daily for 4 weeks
505405|NCT00750139|O3|Outcome|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
505406|NCT00750139|O2|Outcome|Placebo 2-wks|Placebo applied daily for 2-weeks
505407|NCT00750139|O1|Outcome|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
505408|NCT00750139|O4|Outcome|Placebo 4-wks|Placebo control cream applied daily for 4 weeks
505409|NCT00750139|O3|Outcome|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
505410|NCT00750139|O2|Outcome|Placebo 2-weeks|Placebo Control cream applied daily for 2-weeks
505411|NCT00750139|O1|Outcome|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
505412|NCT00750139|E4|Reported Event|Placebo 4-wks|Placebo cream applied daily for 4 weeks
505413|NCT00750139|E3|Reported Event|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
505414|NCT00750139|E2|Reported Event|Placebo 2-wks|Placebo applied daily for 2-weeks
505415|NCT00750139|E1|Reported Event|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
505416|NCT00750152|B3|Baseline|Total|Total of all reporting groups
505417|NCT00750152|B2|Baseline|Placebo-2wks|Placebo cream applied daily for 2 weeks
505418|NCT00750152|B1|Baseline|NAFT-500|Naftin 2% cream applied daily for 2 weeks
505419|NCT00750152|P2|Participant Flow|Placebo-2wks|Placebo cream applied daily for 2 weeks
505420|NCT00750152|P1|Participant Flow|NAFT-500|Naftin 2% cream applied daily for 2 weeks
505421|NCT00750152|O2|Outcome|Placebo-2wks|Placebo cream applied daily for 2 weeks
505422|NCT00750152|O1|Outcome|NAFT-500|Naftin 2% cream applied daily for 2 weeks
505423|NCT00750152|O2|Outcome|Placebo-2wks|Placebo cream applied daily for 2 weeks
505424|NCT00750152|O1|Outcome|NAFT-500|Naftin 2% cream applied daily for 2 weeks
505425|NCT00750152|E2|Reported Event|Placebo-2wks|Placebo cream applied daily for 2 weeks
505426|NCT00750152|E1|Reported Event|NAFT-500|Naftin 2% cream applied daily for 2 weeks
505427|NCT00750191|B3|Baseline|Total|Total of all reporting groups
505428|NCT00750191|B2|Baseline|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.
The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
505429|NCT00750191|B1|Baseline|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.
After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
505430|NCT00750191|P2|Participant Flow|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.
The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
505431|NCT00750191|P1|Participant Flow|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.
After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
505474|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
505705|NCT00751114|B2|Baseline|Sitagliptin|Dose of 100 mg once a day administered with or without food
505432|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.
The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
505478|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy
SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
505433|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.
After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
505434|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.
The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
505435|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.
After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
505436|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.
The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
505437|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.
After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
505438|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.
The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
505439|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.
After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
505440|NCT00750191|E2|Reported Event|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.
The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
505441|NCT00750191|E1|Reported Event|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.
After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
505442|NCT00750204|B3|Baseline|Total|Total of all reporting groups
505443|NCT00750204|B2|Baseline|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.
Conventional MV: Low tidal-volume mechanical ventilation"
505444|NCT00750204|B1|Baseline|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.
APRV: APRV Protocol
Set FiO2 at 0.1 higher than the setting on conventional MV currently used
Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).
Respiratory rate (RR) to equal 60-65% of RR on conventional MV.
Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.
Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.
If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
505445|NCT00750204|P2|Participant Flow|Conventional MV First|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.
Conventional MV: Low tidal-volume mechanical ventilation"
505475|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
505479|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
505480|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
505446|NCT00750204|P1|Participant Flow|Airway Pressure Release Ventilation (APRV) First|Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude Airway Pressure Release Ventilation •Set FiO2 at 0.1 higher than the setting on conventional MV currently used •Tlow = 1.0 second (this setting shall remain unchanged throughout the trial). •Respiratory rate (RR) to equal 60-65% of RR on conventional MV. •Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20. •Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW. •If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (min Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire
505447|NCT00750204|O2|Outcome|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.
Conventional MV: Low tidal-volume mechanical ventilation"
505448|NCT00750204|O1|Outcome|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.
APRV: APRV Protocol
Set FiO2 at 0.1 higher than the setting on conventional MV currently used
Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).
Respiratory rate (RR) to equal 60-65% of RR on conventional MV.
Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.
Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.
If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
505449|NCT00750204|E2|Reported Event|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.
Conventional MV: Low tidal-volume mechanical ventilation"
505450|NCT00750204|E1|Reported Event|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.
APRV: APRV Protocol
Set FiO2 at 0.1 higher than the setting on conventional MV currently used
Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).
Respiratory rate (RR) to equal 60-65% of RR on conventional MV.
Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.
Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.
If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
505451|NCT00750269|B6|Baseline|Total|Total of all reporting groups
505452|NCT00750269|B5|Baseline|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy
SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
505453|NCT00750269|B4|Baseline|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy
SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
505454|NCT00750269|B3|Baseline|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
505455|NCT00750269|B2|Baseline|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
505456|NCT00750269|B1|Baseline|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy
SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
505457|NCT00750269|P5|Participant Flow|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy
SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
505458|NCT00750269|P4|Participant Flow|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy
SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
505459|NCT00750269|P3|Participant Flow|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
505460|NCT00750269|P2|Participant Flow|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
505461|NCT00750269|P1|Participant Flow|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy
SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
505462|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy
SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
505463|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy
SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
505464|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
505465|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
505466|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy
SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
505467|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy
SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
505468|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy
SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
505469|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
505470|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
505471|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy
SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
505472|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy
SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
508460|NCT00758459|O1|Outcome|AZD1236|AZD1236
505481|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
505482|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy
SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
505483|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy
SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
505484|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
505485|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
505486|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
505487|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy
SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
505488|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy
SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
505489|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
505490|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
505491|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
505492|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy
SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
505493|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy
SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
505494|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
505495|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
505496|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
505497|NCT00750269|O2|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy
SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
505498|NCT00750269|O1|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy
SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
505499|NCT00750269|O1|Outcome|All Participants|
505500|NCT00750269|E5|Reported Event|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy
SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
505501|NCT00750269|E4|Reported Event|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy
SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
505502|NCT00750269|E3|Reported Event|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
505503|NCT00750269|E2|Reported Event|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
505504|NCT00750269|E1|Reported Event|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy
SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
505505|NCT00750282|B5|Baseline|Total|Total of all reporting groups
505506|NCT00750282|B4|Baseline|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
505507|NCT00750282|B3|Baseline|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
505508|NCT00750282|B2|Baseline|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
505509|NCT00750282|B1|Baseline|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
505510|NCT00750282|P4|Participant Flow|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
505511|NCT00750282|P3|Participant Flow|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
505512|NCT00750282|P2|Participant Flow|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
505513|NCT00750282|P1|Participant Flow|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 megabequerel (MBq) single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions.
505514|NCT00750282|O4|Outcome|Healthy Volunteer (HV) Group (Part B)|All subjects that were confirmed by consensus panel as healthy volunteers
505515|NCT00750282|O3|Outcome|Alzheimer's (AD) Group (Part B)|"All subjects with consensus panel based diagnosis of probable AD"
505516|NCT00750282|O2|Outcome|Healthy Volunteer (HV) Group (Part A)|All evaluated healthy volunteers
505517|NCT00750282|O1|Outcome|Alzheimer's (AD) Group (Part A)|All evaluated subjects with Alzheimer's disease
505518|NCT00750282|O6|Outcome|Imaging Window 110-130 Min Part B|Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part B.
505519|NCT00750282|O5|Outcome|Imaging Window 90-110 Min Part B|Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part B
505520|NCT00750282|O4|Outcome|Imaging Window 45-60 Min Part B|Kappa coefficient estimate for PET data collected 45-60 min post-injection in Part B
505521|NCT00750282|O3|Outcome|Imaging Window 110-130 Min Part A|Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part A.
505522|NCT00750282|O2|Outcome|Imaging Window 90-110 Min Part A|Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part A
505523|NCT00750282|O1|Outcome|Imaging Window 45-60 Min Part A|Kappa coefficient estimate for PET data collected 45-60 min post-injection in Part A
505524|NCT00750282|O4|Outcome|HV (Specificity) Group (Part B)|All evaluated healthy volunteers from Part B
505525|NCT00750282|O3|Outcome|AD (Sensitivity) Group (Part B)|All evaluated subjects with probable Alzheimer's disease from part B
505526|NCT00750282|O2|Outcome|HV (Specificity) Group (Part A)|All evaluated healthy volunteers from Part A
505527|NCT00750282|O1|Outcome|AD (Sensitivity) Group (Part A)|All evaluated subjects with Alzheimer's disease from Part A
505528|NCT00750282|O2|Outcome|HV (Specificity) Group|All subjects evaluated as healthy volunteer by consensus panel
505529|NCT00750282|O1|Outcome|AD (Sensitivity) Group|All subjects evaluated as probable AD by consensus panel
505530|NCT00750282|O2|Outcome|HV (Specificity) Group|All evaluated healthy volunteers
505531|NCT00750282|O1|Outcome|AD (Sensitivity) Group|All evaluated subjects with Alzheimer's disease
505532|NCT00750282|E4|Reported Event|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
505533|NCT00750282|E3|Reported Event|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
505534|NCT00750282|E2|Reported Event|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
505535|NCT00750282|E1|Reported Event|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
505536|NCT00750308|B1|Baseline|Completed Subjects|Subjects who completed all four treatment arms.
505537|NCT00750308|P12|Participant Flow|Placebo, Ramipril, Tadalafil, Combo|
505538|NCT00750308|P11|Participant Flow|Combo, Tadalafil, Ramipril, Placebo|
505539|NCT00750308|P10|Participant Flow|Ramipril, Placebo, Combo, Tadalafil|
505540|NCT00750308|P9|Participant Flow|Tadalafil, Combo, Placebo, Ramipril|
505541|NCT00750308|P8|Participant Flow|Placebo, Tadalafil, Combo, Ramipril|
505542|NCT00750308|P7|Participant Flow|Combo, Ramipril, Placebo, Tadalafil|
505543|NCT00750308|P6|Participant Flow|Ramipril, Combo, Tadalafil, Placebo|
505544|NCT00750308|P5|Participant Flow|Tadalafil, Placebo, Ramipril, Combo|
505545|NCT00750308|P4|Participant Flow|Placebo, Combo, Ramipril, Tadalafil|
505546|NCT00750308|P3|Participant Flow|Combo, Placebo, Tadalafil, Ramipril|
505547|NCT00750308|P2|Participant Flow|Ramipril, Tadalafil, Placebo, Combo|
505548|NCT00750308|P1|Participant Flow|Tadalafil, Ramipril, Combo, Placebo|
505549|NCT00750308|O4|Outcome|Combination Treatment|Measured during combination (ramipril and tadalafil) in all 18 subjects who completed treatment
505550|NCT00750308|O3|Outcome|Tadalafil Treatment|Measured during tadalafil in all 18 subjects who completed the protocol
505551|NCT00750308|O2|Outcome|Ramipril Treatment|Measured during ramipril treatment in all 18 subjects who completed the protocol
505552|NCT00750308|O1|Outcome|Placebo Treatment|Measured during placebo treatment in all 18 subjects who completed the study
505553|NCT00750308|O4|Outcome|Combination Treatment|Measurements during combination (ramipril and tadalafil) for all 18 subjects who completed the protocol
505554|NCT00750308|O3|Outcome|Tadalafil Treatment|Measurements during tadalafil treatment for all 18 subjects who completed the protocol
505555|NCT00750308|O2|Outcome|Ramipril Treatment|Measurements during ramipril treatment for all 18 subjects who completed the protocol
505556|NCT00750308|O1|Outcome|Placeb Treatment|Measurements during placebo treatment for all 18 subjects who completed the protocol
505557|NCT00750308|E4|Reported Event|Combination Treatment|Any adverse event that occurred during combination (ramipril and tadalafil) treatment in anyone who received combination treatment
505558|NCT00750308|E3|Reported Event|Tadalafil Tretament|Any adverse event that occurred during tadalafil treatment in anyone who received tadalafil treatment
505559|NCT00750308|E2|Reported Event|Ramipril Treatment|Any adverse event that occured durng ramipril treatment in anyone who received ramipril treatment
505560|NCT00750308|E1|Reported Event|Placebo Treatment|Any adverse event that occurred during placebo treatment in anyone who received placebo treatment
505561|NCT00750360|B7|Baseline|Total|Total of all reporting groups
505562|NCT00750360|B6|Baseline|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
505563|NCT00750360|B5|Baseline|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
505564|NCT00750360|B4|Baseline|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
505565|NCT00750360|B3|Baseline|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
505566|NCT00750360|B2|Baseline|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
505567|NCT00750360|B1|Baseline|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
508461|NCT00758459|O2|Outcome|Placebo|Placebo
505568|NCT00750360|P6|Participant Flow|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
505569|NCT00750360|P5|Participant Flow|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
505570|NCT00750360|P4|Participant Flow|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
505571|NCT00750360|P3|Participant Flow|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
578591|NCT00939094|E1|Reported Event|A - AZD2066|AZD2066, 12 mg capsule
505572|NCT00750360|P2|Participant Flow|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
505573|NCT00750360|P1|Participant Flow|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
505574|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
505575|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
505576|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
505577|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
505578|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
505579|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
505580|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
505581|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
505582|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
505583|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
505584|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
505585|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
505586|NCT00750360|O4|Outcome|Group A (Primed), ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
505587|NCT00750360|O3|Outcome|Group A (Primed), ≥ 108 Months to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
505588|NCT00750360|O2|Outcome|Group A (Primed), ≥ 72 Months to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
505589|NCT00750360|O1|Outcome|Group B (Unprimed), ≥ 72 Months to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
505590|NCT00750360|O2|Outcome|Group A (Primed), > 6 Months to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
505591|NCT00750360|O1|Outcome|Group B (Unprimed), > 6 Months to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
505592|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
505593|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
505594|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
505595|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
505596|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
505597|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
505598|NCT00750360|E6|Reported Event|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
505599|NCT00750360|E5|Reported Event|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
505600|NCT00750360|E4|Reported Event|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
505601|NCT00750360|E3|Reported Event|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
505602|NCT00750360|E2|Reported Event|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
505603|NCT00750360|E1|Reported Event|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
505604|NCT00750373|B3|Baseline|Total|Total of all reporting groups
505605|NCT00750373|B2|Baseline|Surgery|Early surgery within 48 hours of randomization
505606|NCT00750373|B1|Baseline|Conventional|Conventional Treatment based on current guidelines
505607|NCT00750373|P2|Participant Flow|Surgery|Early surgery within 48 hours of randomization
505608|NCT00750373|P1|Participant Flow|Conventional|Conventional Treatment based on current guidelines
505609|NCT00750373|O2|Outcome|Surgery|Early surgery within 48 hours of randomization
505610|NCT00750373|O1|Outcome|Conventional|Conventional Treatment based on current guidelines
505611|NCT00750373|E2|Reported Event|Surgery|Early surgery within 48 hours of randomization
505614|NCT00750737|B2|Baseline|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
505615|NCT00750737|B1|Baseline|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
505616|NCT00750737|P2|Participant Flow|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
505617|NCT00750737|P1|Participant Flow|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
505618|NCT00750737|O2|Outcome|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
505619|NCT00750737|O1|Outcome|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
505620|NCT00750737|O2|Outcome|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
505621|NCT00750737|O1|Outcome|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
505622|NCT00750737|E2|Reported Event|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
505623|NCT00750737|E1|Reported Event|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
505624|NCT00750815|B3|Baseline|Total|Total of all reporting groups
505625|NCT00750815|B2|Baseline|B. Phase II - Maximum Planned Dose (MPD)|Participants received Cyclophosphamide and VELCADE at the MPD at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
505626|NCT00750815|B1|Baseline|A. Phase I - Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated:
Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
505627|NCT00750815|P2|Participant Flow|B. Phase II - Maximum Planned Dose (MPD)|Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
505628|NCT00750815|P1|Participant Flow|A. Phase I - Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:
Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
505629|NCT00750815|O2|Outcome|Standard-Risk Myeloma|"Participants eligible for risk stratification with Standard-Risk Myeloma.
Arm A:
Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Arm B:
Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule Arm A."
505630|NCT00750815|O1|Outcome|High-Risk Myeloma|"Participants eligible for risk stratification with High-Risk Myeloma.
Arm A:
Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Arm B:
Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as Arm A."
505631|NCT00750815|O1|Outcome|All Participants|"Arm A:
Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Arm B:
Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study."
505667|NCT00750893|P1|Participant Flow|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
506063|NCT00744055|E2|Reported Event|Placebo|"Placebo in identical looking capsule blister packs
Placebo"
505668|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
505669|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
506094|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
505632|NCT00750815|O1|Outcome|All Participants|"Arm A:
Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Arm B:
Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study."
505633|NCT00750815|O1|Outcome|A. Phase I Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:
Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
505634|NCT00750815|E4|Reported Event|Maximum Tolerated Dose|Participants at Dose Level 4
505635|NCT00750815|E3|Reported Event|Dose Level 3|Participants at Dose Level 3
505636|NCT00750815|E2|Reported Event|Dose Level 2|Participants at Dose Level 2
505637|NCT00750815|E1|Reported Event|Dose Level 1|Participants at Dose Level 1
505638|NCT00750867|B1|Baseline|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
505639|NCT00750867|P1|Participant Flow|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
505640|NCT00750867|O1|Outcome|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
505641|NCT00750867|O1|Outcome|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
505642|NCT00750867|E1|Reported Event|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
505643|NCT00750880|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505644|NCT00750880|P1|Participant Flow|Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 20 weeks (total of 6 infusions).
505645|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505646|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505647|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505648|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505649|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505650|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505651|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505652|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505653|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505654|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505655|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505656|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505657|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505658|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505659|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505660|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
505661|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505662|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
505663|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505664|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
505665|NCT00750880|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
505666|NCT00750893|B1|Baseline|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
505704|NCT00751114|B3|Baseline|Total|Total of all reporting groups
505670|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
505671|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
505672|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
505673|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
505674|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
505675|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
505676|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
505677|NCT00750893|E4|Reported Event|Rotarix Year 1 to Year 6 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during the study period from Year 1 to Year 6.
505678|NCT00750893|E3|Reported Event|Rotarix Year 5 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Year 5 of the study.
505679|NCT00750893|E2|Reported Event|Rotarix Years 3 and 4 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Years 3 and 4 of the study.
505680|NCT00750893|E1|Reported Event|Rotarix Years 1 and 2 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Years 1 and 2 of the study.
505681|NCT00750919|B1|Baseline|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
505682|NCT00750919|P1|Participant Flow|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
505683|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
505684|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
505685|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
505686|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
505687|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
505688|NCT00750919|E1|Reported Event|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
505689|NCT00751036|B3|Baseline|Total|Total of all reporting groups
505690|NCT00751036|B2|Baseline|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
505691|NCT00751036|B1|Baseline|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
505692|NCT00751036|P2|Participant Flow|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
505693|NCT00751036|P1|Participant Flow|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
505694|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
505695|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
505696|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
505697|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
505698|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
505699|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
505700|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
505701|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
505702|NCT00751036|E2|Reported Event|Imatinib 800 mg|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
505703|NCT00751036|E1|Reported Event|Nilotinib 800 mg|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
505706|NCT00751114|B1|Baseline|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505707|NCT00751114|P2|Participant Flow|Sitagliptin|Dose of 100 mg once a day administered with or without food
506234|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
505708|NCT00751114|P1|Participant Flow|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the Fasting Plasma Glucose (FPG) target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505709|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
505710|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505711|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
505712|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505713|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
505714|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505715|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
505716|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505717|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505718|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
505719|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505720|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
505721|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505722|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
505723|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505724|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
505725|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505726|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
505727|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505728|NCT00751114|E2|Reported Event|Sitagliptin|Dose of 100 mg once a day administered with or without food
505729|NCT00751114|E1|Reported Event|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
505730|NCT00751140|B1|Baseline|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).
Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
505731|NCT00751140|P1|Participant Flow|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).
Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
505732|NCT00751140|O4|Outcome|Robot-assisted RNU Lymph Node Count|Lymph Node Count for Robot-assisted RNU Procedure Group
505733|NCT00751140|O3|Outcome|Laparoscopic RNU Lymph Node Count|Lymph Node Count for Laparoscopic RNU Procedure Group
505734|NCT00751140|O2|Outcome|Open RNU Lymph Node Count|Lymph Node Count for Open RNU Procedure Group
505735|NCT00751140|O1|Outcome|Total Lymph Node Count|Total Lymph Node Count for All Participants
505736|NCT00751140|O1|Outcome|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).
Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
506013|NCT00743652|E3|Reported Event|Group 3 (Infant Series)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series)
505786|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505737|NCT00751140|E1|Reported Event|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).
Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
505738|NCT00751179|B3|Baseline|Total|Total of all reporting groups
505739|NCT00751179|B2|Baseline|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
505740|NCT00751179|B1|Baseline|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505741|NCT00751179|P2|Participant Flow|Succinylcholine|An intubation dose of succinylcholine (suc) was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
505742|NCT00751179|P1|Participant Flow|Rocuronium - Sugammadex|An intubation dose of rocuronium (roc) was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex (sug) was administered for reversal of neuromuscular blockade.
505743|NCT00751179|O1|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
505744|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505745|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
505746|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505747|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505748|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505749|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
505750|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505751|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505752|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
505753|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505754|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505755|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
505756|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505757|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
505758|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505759|NCT00751179|E2|Reported Event|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
505760|NCT00751179|E1|Reported Event|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
505785|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505761|NCT00751296|B1|Baseline|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.
Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles)."
505762|NCT00751296|P1|Participant Flow|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.
Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).
Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
505763|NCT00751296|O1|Outcome|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.
Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).
Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
505764|NCT00751296|O1|Outcome|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.
Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).
Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
505765|NCT00751296|E1|Reported Event|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.
Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).
Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
505766|NCT00737633|B3|Baseline|Total|Total of all reporting groups
505767|NCT00737633|B2|Baseline|72-week Population|subjects who were randomized to active during previous study
505768|NCT00737633|B1|Baseline|16-week Population|subjects who were randomized to placebo in previous study
505769|NCT00737633|P2|Participant Flow|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
505770|NCT00737633|P1|Participant Flow|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
505771|NCT00737633|O2|Outcome|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
505772|NCT00737633|O1|Outcome|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
505773|NCT00737633|O2|Outcome|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
505774|NCT00737633|O1|Outcome|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
505775|NCT00737633|E2|Reported Event|72-week Population|subjects who were randomized to active during previous study
505776|NCT00737633|E1|Reported Event|16-week Population|subjects who were randomized to placebo in previous study
505777|NCT00737672|B3|Baseline|Total|Total of all reporting groups
505778|NCT00737672|B2|Baseline|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm.
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis."
505779|NCT00737672|B1|Baseline|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm.
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis."
505780|NCT00737672|P2|Participant Flow|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA)in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505781|NCT00737672|P1|Participant Flow|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505782|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505783|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505784|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505826|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505787|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505788|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505789|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505790|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505791|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505792|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505793|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505794|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505795|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505796|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505797|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505798|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505799|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505800|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505801|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505802|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505803|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505827|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505804|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505805|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505806|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505807|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505808|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505809|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505810|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505811|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505812|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
505813|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
505814|NCT00737672|E2|Reported Event|PTA Treatment Group|Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
505815|NCT00737672|E1|Reported Event|VIABAHN Treatment Group|Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
505816|NCT00737711|B1|Baseline|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505817|NCT00737711|P1|Participant Flow|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 microgram per kilogram of body weight (mcg/kg) of Methoxy polyethylene glycol-epoetin beta (MIRCERA/RO0503821), intravenously once every two weeks for 16 weeks. A telephonic / physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505818|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505819|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505820|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505821|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505822|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505823|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505824|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505825|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505828|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505858|NCT00738023|B3|Baseline|Total|Total of all reporting groups
505829|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505830|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505831|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505832|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505833|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505834|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505835|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505836|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505837|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505838|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505839|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505840|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505841|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505842|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505843|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505844|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505845|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505846|NCT00737711|E1|Reported Event|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
505847|NCT00737737|B3|Baseline|Total|Total of all reporting groups
505848|NCT00737737|B2|Baseline|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
505849|NCT00737737|B1|Baseline|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg
MS Contin"
505850|NCT00737737|P2|Participant Flow|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
505851|NCT00737737|P1|Participant Flow|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg
MS Contin"
505852|NCT00737737|O2|Outcome|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
505853|NCT00737737|O1|Outcome|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg
MS Contin"
505854|NCT00737737|O2|Outcome|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
505855|NCT00737737|O1|Outcome|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg
MS Contin"
505856|NCT00737737|E2|Reported Event|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
505938|NCT00743652|P5|Participant Flow|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505857|NCT00737737|E1|Reported Event|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg
MS Contin"
505859|NCT00738023|B2|Baseline|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
505860|NCT00738023|B1|Baseline|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
505861|NCT00738023|P2|Participant Flow|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
505862|NCT00738023|P1|Participant Flow|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
505863|NCT00738023|O1|Outcome|Diabetics|"Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
Rosiglitazone: Diabetic subjects will be receive rosiglitazone for 6 weeks
Normal saline 0.9%: Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours
Intralipid 20%: Intralipid 20% at 40ml/hr intravenously for 48 hours"
505864|NCT00738023|O1|Outcome|Diabetics|"Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
Rosiglitazone: Diabetic subjects will be receive rosiglitazone for 6 weeks
Normal saline 0.9%: Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours
Intralipid 20%: Intralipid 20% at 40ml/hr intravenously for 48 hours"
505865|NCT00738023|O2|Outcome|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
505866|NCT00738023|O1|Outcome|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
505867|NCT00738023|E2|Reported Event|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
505868|NCT00738023|E1|Reported Event|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
505869|NCT00738049|B3|Baseline|Total|Total of all reporting groups
505870|NCT00738049|B2|Baseline|Group 2|Group 2 received placebo during Phase 1 then oral Darusentan 100 mg during Phase 2.
505871|NCT00738049|B1|Baseline|Group 1|Group 1 received oral Darusentan 100mg during Phase 1 then placebo during Phase 2.
505872|NCT00738049|P2|Participant Flow|Placebo, Then Darusentan 100mg|Patients were randomized to oral placebo for 14 days, then underwent PET imaging. Study patients then received Darusentan 100mg for 14 days. The patients underwent cardiac PET imaging followed by a 14 day washout period and final PET scan. Patients and physicians were blinded to medication assignment.
505873|NCT00738049|P1|Participant Flow|Darusentan Then Placebo,|Patients were randomized to oral Darusentan 100mg for 14 days and then underwent cardiac PET imaging. They then received placebo for 14 days and underwent PET imaging, followed by a washout period of 14 days and completed the final cardiac PET scan. Patients and physicians were blinded to medication assignment.
505874|NCT00738049|O2|Outcome|Darusentan 100mg|All patients underwent a assessment of CFR while receiving darusentan
505875|NCT00738049|O1|Outcome|Baseline|All patients underwent a baseline assessment of CFR before receiving darusentan or placebo
505876|NCT00738049|O4|Outcome|Baseline at Hyperemia|All patients underwent a baseline assessment of hyperemic flow before receiving darusentan or placebo
505877|NCT00738049|O3|Outcome|Baseline at Rest|All patients underwent a baseline assessment of resting flow before receiving darusentan or placebo
505878|NCT00738049|O2|Outcome|Darusentan 100mg at Hyperemia|All patients underwent assessment of hyperemic flow while receiving darusentan
505879|NCT00738049|O1|Outcome|Darusentan 100mg at Rest|All patients underwent assessment of rest flow while receiving darusentan
505880|NCT00738049|O2|Outcome|Darusentan 100mg|All patients underwent a baseline assessment of Markovian homogeneity while taking darusentan
505881|NCT00738049|O1|Outcome|Baseline|All patients underwent a baseline assessment of Markovian homogeneity before receiving darusentan or placebo
505882|NCT00738049|E2|Reported Event|Group 2|Received placebo during Phase 1, Darusentan 100mg during Phase 2
505883|NCT00738049|E1|Reported Event|Group 1|Darusentan 100mg during Phase 1, Placebo during Phase 2
505884|NCT00738062|B4|Baseline|Total|Total of all reporting groups
505885|NCT00738062|B3|Baseline|Double-blind Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505886|NCT00738062|B2|Baseline|Double-blind Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505887|NCT00738062|B1|Baseline|Open-Label Droxidopa|Only participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
505888|NCT00738062|P3|Participant Flow|Double-blind Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505939|NCT00743652|P4|Participant Flow|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505889|NCT00738062|P2|Participant Flow|Double-blind Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505891|NCT00738062|O2|Outcome|Placebo|"Placebo
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505892|NCT00738062|O1|Outcome|Droxidopa|"Study medication
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505893|NCT00738062|O2|Outcome|Placebo|"Placebo
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505894|NCT00738062|O1|Outcome|Droxidopa|"Study medication
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505895|NCT00738062|O2|Outcome|Placebo|"Placebo
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505896|NCT00738062|O1|Outcome|Droxidopa|"Study medication
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505897|NCT00738062|O2|Outcome|Placebo|"Placebo
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505898|NCT00738062|O1|Outcome|Droxidopa|"Study medication
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505899|NCT00738062|O2|Outcome|Placebo|"Placebo
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505900|NCT00738062|O1|Outcome|Droxidopa|"Study medication
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505901|NCT00738062|O2|Outcome|Placebo|"Placebo
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505902|NCT00738062|O1|Outcome|Droxidopa|"Study medication
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505903|NCT00738062|O2|Outcome|Placebo|"Placebo
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505904|NCT00738062|O1|Outcome|Droxidopa|"Study medication
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505905|NCT00738062|O2|Outcome|Placebo|"Placebo
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505906|NCT00738062|O1|Outcome|Droxidopa|"Study medication
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505907|NCT00738062|O2|Outcome|Placebo|"Placebo
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505908|NCT00738062|O1|Outcome|Droxidopa|"Study medication
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505909|NCT00738062|E5|Reported Event|Total Droxidopa|All Patients exposed to droxidopa
505910|NCT00738062|E4|Reported Event|Long-Term Follow-up|Open-label treatment with droxidopa (t.i.d) following the double-blind randomization phase.
505911|NCT00738062|E3|Reported Event|Double-blind Placebo|"Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505912|NCT00738062|E2|Reported Event|Double-blind Droxidopa|"Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
505913|NCT00738062|E1|Reported Event|Three Month Open-Label Droxidopa|all patients who participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
505914|NCT00743483|B1|Baseline|BSSL|Bucelipase alfa (INN): oral suspension, 170 mg BSSL, 3 times daily for 5-6 days
505915|NCT00743483|P1|Participant Flow|rhBSSL|Oral suspension, 170 mg rhBSSL, 3 times daily for 5-6 days
505916|NCT00743483|O1|Outcome|rhBSSL|oral suspension, 170 mg, 3 times daily for 5-6 days
505917|NCT00743483|E1|Reported Event|BSSL|Oral suspension, 170 mg, 3 times daily for 5-6 days
505918|NCT00743509|B1|Baseline|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.
Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.
Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
508462|NCT00758459|O1|Outcome|AZD1236|AZD1236
505919|NCT00743509|P1|Participant Flow|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.
Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.
Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
505920|NCT00743509|O1|Outcome|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.
Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.
Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
505921|NCT00743509|O1|Outcome|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.
Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.
Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
505922|NCT00743509|E1|Reported Event|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.
Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.
Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
505923|NCT00743574|B1|Baseline|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505924|NCT00743574|P1|Participant Flow|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505925|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505926|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505927|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505928|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505929|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505930|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505931|NCT00743574|E1|Reported Event|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505932|NCT00743652|B6|Baseline|Total|Total of all reporting groups
505933|NCT00743652|B5|Baseline|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505934|NCT00743652|B4|Baseline|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505935|NCT00743652|B3|Baseline|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505936|NCT00743652|B2|Baseline|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505937|NCT00743652|B1|Baseline|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
506062|NCT00744055|O1|Outcome|Prazosin|"prazosin (16mg/day)
Prazosin: prazosin (16mg/day) 2 times a day"
505940|NCT00743652|P3|Participant Flow|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
506235|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
505941|NCT00743652|P2|Participant Flow|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505942|NCT00743652|P1|Participant Flow|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505943|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505944|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505945|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505946|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505947|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505948|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505949|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505950|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505951|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505952|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505953|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505954|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505955|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505956|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505957|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505958|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505959|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505960|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505961|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505962|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505986|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
507294|NCT00753896|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
505963|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505964|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505965|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505966|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505967|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505968|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505969|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505970|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505971|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505972|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505973|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505974|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505975|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505976|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505977|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505978|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505979|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505980|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505981|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505982|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505983|NCT00743652|O1|Outcome|13vPnC (All Participants)|All participants 6 weeks to <5 years of age who received at least one single IM 0.5 mL dose of 13vPnC in either the infant series or the toddler dose.
505984|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505985|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505987|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505988|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505989|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505990|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505991|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505992|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505993|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505994|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505995|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505996|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505997|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505998|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505999|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
506000|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
506001|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
506002|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
506003|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
506004|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
506005|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
506006|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
506007|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
506008|NCT00743652|E8|Reported Event|Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
506009|NCT00743652|E7|Reported Event|Group 4 (2 Catch-Up Doses)|Participants ≥12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
506010|NCT00743652|E6|Reported Event|Group 3 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
506011|NCT00743652|E5|Reported Event|Group 2 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
506012|NCT00743652|E4|Reported Event|Group 1 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
506014|NCT00743652|E2|Reported Event|Group 2 (Infant Series)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series)
506015|NCT00743652|E1|Reported Event|Group 1 (Infant Series)|Participants 6 weeks to <10 months of age with 0 prior doses of Prevnar received 3 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series).
506016|NCT00743717|B3|Baseline|Total|Total of all reporting groups
506017|NCT00743717|B2|Baseline|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
506018|NCT00743717|B1|Baseline|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
506019|NCT00743717|P2|Participant Flow|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
506020|NCT00743717|P1|Participant Flow|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
506021|NCT00743717|O2|Outcome|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
506022|NCT00743717|O1|Outcome|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
506023|NCT00743717|E2|Reported Event|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
506024|NCT00743717|E1|Reported Event|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
506025|NCT00743730|B4|Baseline|Total|Total of all reporting groups
506026|NCT00743730|B3|Baseline|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis
Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
506027|NCT00743730|B2|Baseline|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal
Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
506028|NCT00743730|B1|Baseline|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal
Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
506029|NCT00743730|P3|Participant Flow|Medication as Needed|"Intermittent opioid administered IV on an as needed basis
Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
506030|NCT00743730|P2|Participant Flow|PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal
Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
506031|NCT00743730|P1|Participant Flow|PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal
Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
506032|NCT00743730|O3|Outcome|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis
Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
506033|NCT00743730|O2|Outcome|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal
Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
506034|NCT00743730|O1|Outcome|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal
Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
506035|NCT00743730|O3|Outcome|Intermittent Opioid on as Needed Basis|"Intermittent opioid administered IV on an as needed basis
Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
506064|NCT00744055|E1|Reported Event|Prazosin|"prazosin (16mg/day)
Prazosin: prazosin (16mg/day) 2 times a day"
506065|NCT00744237|B4|Baseline|Total|Total of all reporting groups
506036|NCT00743730|O2|Outcome|PNCA Without Basal|"Parent and Nurse Controlled Analgesics without basal
Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
506037|NCT00743730|O1|Outcome|PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal
Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
506038|NCT00743730|E3|Reported Event|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis
Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
506039|NCT00743730|E2|Reported Event|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal
Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
506040|NCT00743730|E1|Reported Event|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal
Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
506041|NCT00744042|B1|Baseline|Asfotase Alfa|All enrolled patients receive a single IV (intravenous) dose of Asfotase Alfa of 2 mg/kg followed by 7 days of observation. Following an assessment of safety data by an independent Data Safety Monitoring Board (DSMB), patients begin thrice weekly SC (subcutaneous) injections of Asfotase Alfa at a dose of 1 mg/kg for the remaining 23 weeks of the study.
506042|NCT00744042|P1|Participant Flow|Asfotase Alfa|All patients received an initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa for the first week followed by regular administration of subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times/week (total 3 mg/kg/week).
506043|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
506044|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
506045|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2mg/mg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
506046|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
506047|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
506048|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2 mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2 mg/kg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
506049|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
506050|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
506051|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2 mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2 mg/kg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
506052|NCT00744042|O1|Outcome|Asfotase Alfa|All HPP affected infants will receive a single IV (intravenous) dose of Asfotase Alfa of 2 mg/kg followed by 7 days of observation. Following an assessment of safety data by an independent Data Safety Monitoring Board (DSMB), patients will then begin every other day SC (subcutaneous) injections of Asfotase Alfa at a dose of 1 mg/kg for 23 weeks. End of Study will be at 24 weeks.
506053|NCT00744042|E1|Reported Event|Asfotase Alfa|All patients who received any asfotase alfa treatment, regardless of whether they were lost to follow-up or dropped out of the trial.
506054|NCT00744055|B3|Baseline|Total|Total of all reporting groups
506055|NCT00744055|B2|Baseline|Placebo|men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
506056|NCT00744055|B1|Baseline|Prazosin|men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
506057|NCT00744055|P2|Participant Flow|Placebo|"Placebo in identical looking capsule blister packs
Placebo: Placebo"
506058|NCT00744055|P1|Participant Flow|Prazosin|"prazosin (16mg/day)
Prazosin: prazosin (16mg/day) 2 times a day"
506059|NCT00744055|O2|Outcome|Placebo|"Placebo in identical looking capsule blister packs
Placebo"
506060|NCT00744055|O1|Outcome|Prazosin|"prazosin (16mg/day)
Prazosin: prazosin (16mg/day) 2 times a day"
506061|NCT00744055|O2|Outcome|Placebo|"Placebo in identical looking capsule blister packs
Placebo"
506066|NCT00744237|B3|Baseline|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Open-label amlodipine may be given"
506067|NCT00744237|B2|Baseline|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
Open-label amlodipine may be given"
506068|NCT00744237|B1|Baseline|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
Open-label amlodipine may be given"
506069|NCT00744237|P3|Participant Flow|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Open-label amlodipine may be given"
506070|NCT00744237|P2|Participant Flow|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
Open-label amlodipine may be given"
506071|NCT00744237|P1|Participant Flow|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
Open-label amlodipine may be given"
506072|NCT00744237|O3|Outcome|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Open-label amlodipine may be given"
506073|NCT00744237|O2|Outcome|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
Open-label amlodipine may be given"
506074|NCT00744237|O1|Outcome|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
Open-label amlodipine may be given"
506075|NCT00744237|O3|Outcome|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Open-label amlodipine may be given"
506076|NCT00744237|O2|Outcome|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
Open-label amlodipine may be given"
506077|NCT00744237|O1|Outcome|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
Open-label amlodipine may be given"
506078|NCT00744237|E3|Reported Event|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Open-label amlodipine may be given"
506079|NCT00744237|E2|Reported Event|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
Open-label amlodipine may be given"
506080|NCT00744237|E1|Reported Event|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
Open-label amlodipine may be given"
506081|NCT00744263|B3|Baseline|Total|Total of all reporting groups
506082|NCT00744263|B2|Baseline|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
506083|NCT00744263|B1|Baseline|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
506084|NCT00744263|P2|Participant Flow|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
506085|NCT00744263|P1|Participant Flow|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
506086|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
506087|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
506088|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
506089|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
506090|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
506091|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
506092|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
506231|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506093|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
506095|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
506096|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
506097|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
506098|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
506099|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
506100|NCT00744263|E4|Reported Event|Placebo Immunogenicity Subset|Participants included in immunogenicity subset who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other AEs from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
506101|NCT00744263|E3|Reported Event|13vPnC Immunogenicity Subset|Participants included in immunogenicity subset who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other adverse events (AEs) from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
506102|NCT00744263|E2|Reported Event|Placebo Safety Set|All participants who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
506103|NCT00744263|E1|Reported Event|13vPnC Safety Set|All Participants who received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1, were assessed for serious adverse events (SAEs) from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
506104|NCT00744328|B4|Baseline|Total|Total of all reporting groups
506105|NCT00744328|B3|Baseline|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
506106|NCT00744328|B2|Baseline|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day
Sertraline: Sertraline dose will range from 50 - 200 mg/day"
506107|NCT00744328|B1|Baseline|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day
Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
506108|NCT00744328|P3|Participant Flow|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
506109|NCT00744328|P2|Participant Flow|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day
Sertraline: Sertraline dose will range from 50 - 200 mg/day"
506110|NCT00744328|P1|Participant Flow|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day
Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
506111|NCT00744328|O3|Outcome|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
506112|NCT00744328|O2|Outcome|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day
Sertraline: Sertraline dose will range from 50 - 200 mg/day"
506113|NCT00744328|O1|Outcome|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day
Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
506114|NCT00744328|E3|Reported Event|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
506115|NCT00744328|E2|Reported Event|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day
Sertraline: Sertraline dose will range from 50 - 200 mg/day"
506116|NCT00744328|E1|Reported Event|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day
Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
506117|NCT00744380|B3|Baseline|Total|Total of all reporting groups
506118|NCT00744380|B2|Baseline|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506119|NCT00744380|B1|Baseline|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506120|NCT00744380|P2|Participant Flow|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506157|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506159|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506236|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506121|NCT00744380|P1|Participant Flow|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506122|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506123|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506124|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506125|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506126|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506127|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506128|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506129|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506130|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506131|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506132|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506133|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506158|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
508463|NCT00758459|O2|Outcome|Placebo|Placebo
506134|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506135|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506136|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506137|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506138|NCT00744380|E2|Reported Event|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506139|NCT00744380|E1|Reported Event|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
506140|NCT00744497|B3|Baseline|Total|Total of all reporting groups
506141|NCT00744497|B2|Baseline|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506142|NCT00744497|B1|Baseline|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506143|NCT00744497|P2|Participant Flow|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506144|NCT00744497|P1|Participant Flow|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506145|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506146|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506147|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506148|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506149|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506150|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506151|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506152|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506153|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506154|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506155|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506156|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506230|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506160|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506161|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506162|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506163|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506164|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506165|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506166|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506167|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506168|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506169|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506170|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506171|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506172|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506173|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506174|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506175|NCT00744497|E2|Reported Event|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506176|NCT00744497|E1|Reported Event|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
506177|NCT00744523|B3|Baseline|Total|Total of all reporting groups
506178|NCT00744523|B2|Baseline|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506179|NCT00744523|B1|Baseline|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506180|NCT00744523|P2|Participant Flow|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506181|NCT00744523|P1|Participant Flow|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506182|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506183|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506184|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506185|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506186|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506187|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506188|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506189|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506190|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506191|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506192|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506193|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506194|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
506195|NCT00744523|O1|Outcome|MO.MA Training Cases (Roll-In)|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506196|NCT00744523|E2|Reported Event|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506197|NCT00744523|E1|Reported Event|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
506198|NCT00744627|B3|Baseline|Total|Total of all reporting groups
506199|NCT00744627|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506200|NCT00744627|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506201|NCT00744627|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506202|NCT00744627|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506203|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506204|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506205|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506206|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506207|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506208|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506209|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506210|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506211|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506212|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506213|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506214|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506215|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506216|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506217|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506218|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506219|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506220|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506221|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506222|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506223|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506224|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506225|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506226|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506227|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506228|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506229|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506232|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506233|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506237|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506238|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506239|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506240|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506241|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506242|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506243|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506244|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506245|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506246|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506247|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506248|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506249|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506250|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506251|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506252|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506253|NCT00744627|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
506254|NCT00744627|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
506255|NCT00744653|B1|Baseline|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
506256|NCT00744653|P1|Participant Flow|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
506257|NCT00744653|O1|Outcome|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
506258|NCT00744653|O1|Outcome|Electrochemotherapy|All patients treated with electrochemotherapy
506259|NCT00744653|O1|Outcome|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
506260|NCT00744653|E1|Reported Event|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
506261|NCT00744692|B1|Baseline|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506262|NCT00744692|P1|Participant Flow|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506263|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506264|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506265|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506266|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506267|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506268|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506269|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506270|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506271|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506272|NCT00744692|E1|Reported Event|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant
Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
Reduced Intensity Conditioning"
506626|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
506273|NCT00744757|B1|Baseline|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506274|NCT00744757|P1|Participant Flow|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506275|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506276|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506277|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506278|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506279|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506280|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506281|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506282|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506283|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506284|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506285|NCT00744757|E1|Reported Event|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
506286|NCT00744848|B3|Baseline|Total|Total of all reporting groups
506287|NCT00744848|B2|Baseline|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
506288|NCT00744848|B1|Baseline|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
506289|NCT00744848|P2|Participant Flow|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
506290|NCT00744848|P1|Participant Flow|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
506291|NCT00744848|O2|Outcome|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
506292|NCT00744848|O1|Outcome|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
506293|NCT00744848|E2|Reported Event|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
506294|NCT00744848|E1|Reported Event|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
506295|NCT00744874|B1|Baseline|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506296|NCT00744874|P1|Participant Flow|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506297|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506298|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506627|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
506299|NCT00744874|O1|Outcome|Cumulative Radio Frequency Time for PV Isolation|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506300|NCT00744874|O3|Outcome|Quality of Life Scores at 6 Months|Quality of life scores at 6 months or 6 months before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506301|NCT00744874|O2|Outcome|Quality of Life Scores at 3 Months|Quality of life scores at 3 months or 3 months before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506302|NCT00744874|O1|Outcome|Baseline Quality of Life Scores|Quality of life scores at baseline or before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506303|NCT00744874|O3|Outcome|Ablated Patients Symptom Severity Score at 6 Months|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
506304|NCT00744874|O2|Outcome|Ablated Patients Symptom Severity Score at 3 Months|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.
506305|NCT00744874|O1|Outcome|Ablated Patients Symptom Severity Score at Baseline|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at baseline.
506306|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506307|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506308|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506309|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506310|NCT00744874|E1|Reported Event|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
506311|NCT00744939|B5|Baseline|Total|Total of all reporting groups
506312|NCT00744939|B4|Baseline|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
506313|NCT00744939|B3|Baseline|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
506314|NCT00744939|B2|Baseline|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
506315|NCT00744939|B1|Baseline|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
506316|NCT00744939|P1|Participant Flow|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
506317|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
506318|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
506319|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
506320|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
506321|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
506322|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
506323|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
506324|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
506325|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
506326|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
506327|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
506328|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
506366|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506329|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
506330|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
506331|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
506332|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
506333|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
506334|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
506335|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
506336|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
506337|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
506338|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
506339|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
506340|NCT00744939|O2|Outcome|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
506341|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
506342|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
506343|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
506344|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
506345|NCT00744939|O2|Outcome|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
506346|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
506347|NCT00744939|E4|Reported Event|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
506348|NCT00744939|E3|Reported Event|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
506349|NCT00744939|E2|Reported Event|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
506350|NCT00744939|E1|Reported Event|Mild Renal Impairment|Participants with eGFR >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
506351|NCT00744978|B3|Baseline|Total|Total of all reporting groups
506352|NCT00744978|B2|Baseline|Placebo Then Varenicline|Placebo twice a day (BID) initiated with a 2-week titration regimen (Week 1: once a day [QD]; Week 2: BID), followed by varenicline 1 mg BID initiated with a 2-week titration regimen (Week 1: 0.5 mg QD; Week 2: 0.5 mg BID).
506353|NCT00744978|B1|Baseline|Varenicline Then Placebo|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
506354|NCT00744978|P2|Participant Flow|Placebo Then Varenicline|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks; then varenicline 0.5 mg once daily for 1 week followed by 0.5 mg BID for 1 week followed by 1 mg BID for 4 weeks.
506355|NCT00744978|P1|Participant Flow|Varenicline Then Placebo|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
506356|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506357|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506358|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506359|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506360|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506361|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506362|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506363|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506364|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506365|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506367|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506368|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506628|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
506369|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506370|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506371|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506372|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506373|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506374|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506375|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506376|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506377|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506378|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506379|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506380|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506381|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506382|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506383|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506384|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506385|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506386|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506387|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506388|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506389|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506390|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506391|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506392|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506393|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506394|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506395|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506396|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506397|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506398|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506399|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506400|NCT00744978|E2|Reported Event|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
506401|NCT00744978|E1|Reported Event|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
506402|NCT00745030|B3|Baseline|Total|Total of all reporting groups
506403|NCT00745030|B2|Baseline|Placebo 8 mg Tablets|Placebo 8 mg tablets
506404|NCT00745030|B1|Baseline|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
506405|NCT00745030|P2|Participant Flow|Placebo 8 mg Tablets|Placebo 8 mg tablets
506406|NCT00745030|P1|Participant Flow|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
506407|NCT00745030|O2|Outcome|Placebo 8 mg Tablets|Placebo 8 mg tablets
506408|NCT00745030|O1|Outcome|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
506409|NCT00745030|E2|Reported Event|Placebo 8 mg Tablets|Placebo 8 mg tablets
506410|NCT00745030|E1|Reported Event|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
506411|NCT00745095|B7|Baseline|Total|Total of all reporting groups
506412|NCT00745095|B6|Baseline|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
506413|NCT00745095|B5|Baseline|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
506414|NCT00745095|B4|Baseline|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
506415|NCT00745095|B3|Baseline|SCI PIEE (Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
506416|NCT00745095|B2|Baseline|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
506417|NCT00745095|B1|Baseline|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG)
506418|NCT00745095|P6|Participant Flow|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no neostigmine plus glycopyrrolate [NG])
506419|NCT00745095|P5|Participant Flow|Control MoviPrep® Only|(Control, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] only (no neostigmine plus glycopyrrolate [NG])
506420|NCT00745095|P4|Participant Flow|SCI PIEE (With NG)|"(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (with neostigmine plus glycopyrrolate [NG])
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
506421|NCT00745095|P3|Participant Flow|SCI PIEE (Without NG)|(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (without neostigmine plus glycopyrrolate [NG])
506422|NCT00745095|P2|Participant Flow|SCI MoviPrep® (With NG)|"(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50ml/min and SCI, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (with neostigmine plus glycopyrrolate [NG])
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
506423|NCT00745095|P1|Participant Flow|SCI MoviPrep® (Without NG)|(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50 and SCI, GFR>=50) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (without neostigmine plus glycopyrrolate [NG])
506424|NCT00745095|O6|Outcome|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
506425|NCT00745095|O5|Outcome|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
506426|NCT00745095|O4|Outcome|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
506427|NCT00745095|O3|Outcome|SCI PIEE ( Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
506428|NCT00745095|O2|Outcome|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
506429|NCT00745095|O1|Outcome|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® ( without NG)
506430|NCT00745095|O6|Outcome|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
506431|NCT00745095|O5|Outcome|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
506432|NCT00745095|O4|Outcome|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
506433|NCT00745095|O3|Outcome|SCI PIEE (Without NG)|"(SCI, GFR>=50ml/min) PIEE (without NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
506434|NCT00745095|O2|Outcome|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® (withNG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
506435|NCT00745095|O1|Outcome|SCI MoviPrep® (Without NG)|(SCI, GFR<=50 and GFR >=50) MoviPrep® (without NG)
506436|NCT00745095|E6|Reported Event|SCI PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
506437|NCT00745095|E5|Reported Event|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
506438|NCT00745095|E4|Reported Event|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
506439|NCT00745095|E3|Reported Event|SCI PIEE (Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
506440|NCT00745095|E2|Reported Event|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
506441|NCT00745095|E1|Reported Event|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (without NG)
506442|NCT00745251|B3|Baseline|Total|Total of all reporting groups
506443|NCT00745251|B2|Baseline|Top Dose|PHEN/TPM 15mg/92mg
506444|NCT00745251|B1|Baseline|Placebo|
506445|NCT00745251|P2|Participant Flow|Top Dose|PHEN/TPM 15mg/92mg
506446|NCT00745251|P1|Participant Flow|Placebo|
506447|NCT00745251|O2|Outcome|Top Dose|PHEN/TPM 15mg/92mg
506448|NCT00745251|O1|Outcome|Placebo|
506449|NCT00745251|O2|Outcome|Top Dose|PHEN/TPM 15mg/92mg
506450|NCT00745251|O1|Outcome|Placebo|
506451|NCT00745251|E2|Reported Event|Top Dose|PHEN/TPM 15mg/92mg
506452|NCT00745251|E1|Reported Event|Placebo|
506453|NCT00745290|B3|Baseline|Total|Total of all reporting groups
506454|NCT00745290|B2|Baseline|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
506455|NCT00745290|B1|Baseline|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
506456|NCT00745290|P2|Participant Flow|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
506457|NCT00745290|P1|Participant Flow|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
506458|NCT00745290|O2|Outcome|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
506459|NCT00745290|O1|Outcome|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
506460|NCT00745290|E2|Reported Event|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
506461|NCT00745290|E1|Reported Event|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
506462|NCT00751348|B3|Baseline|Total|Total of all reporting groups
506487|NCT00751400|B1|Baseline|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506463|NCT00751348|B2|Baseline|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506464|NCT00751348|B1|Baseline|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506465|NCT00751348|P2|Participant Flow|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506466|NCT00751348|P1|Participant Flow|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506467|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506468|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506469|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506470|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506471|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506472|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506473|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506474|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506475|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506476|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506477|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506478|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506479|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506480|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506481|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506482|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506483|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506484|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506485|NCT00751348|E2|Reported Event|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
506486|NCT00751348|E1|Reported Event|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
506566|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
506567|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
506488|NCT00751400|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
507295|NCT00753922|B5|Baseline|Total|Total of all reporting groups
506489|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506490|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506491|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506492|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506493|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506494|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506495|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506496|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506497|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506498|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506499|NCT00751400|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
506500|NCT00751530|B3|Baseline|Total|Total of all reporting groups
506501|NCT00751530|B2|Baseline|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
506502|NCT00751530|B1|Baseline|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
506503|NCT00751530|P2|Participant Flow|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
506504|NCT00751530|P1|Participant Flow|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
506505|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
506506|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
506507|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
506508|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
506509|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
506510|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
506511|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
506512|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
506513|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
506514|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
506515|NCT00751530|E2|Reported Event|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
506516|NCT00751530|E1|Reported Event|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
506517|NCT00751621|B1|Baseline|IgPro20|Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506518|NCT00751621|P1|Participant Flow|IgPro20|Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506519|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506520|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506521|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506522|NCT00751621|O2|Outcome|IgPro20 - At End of Study|SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
506523|NCT00751621|O1|Outcome|IgPro20 - At Baseline|SF-36 score at baseline.
506524|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506568|NCT00751881|O1|Outcome|Placebo|Placebo once daily
506624|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
506525|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506526|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506527|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506528|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506529|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506530|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506531|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506532|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506533|NCT00751621|E1|Reported Event|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
506534|NCT00751634|B1|Baseline|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
506535|NCT00751634|P1|Participant Flow|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
506536|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
506537|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
506538|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
506539|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
506540|NCT00751634|O1|Outcome|Treatment Group at 0, 1, 2, 6 Hours|Application of the Gaymar Rapr-Round device per approved use
506541|NCT00751634|E1|Reported Event|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
506542|NCT00751777|B3|Baseline|Total|Total of all reporting groups
506543|NCT00751777|B2|Baseline|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
506544|NCT00751777|B1|Baseline|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
506545|NCT00751777|P2|Participant Flow|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
506546|NCT00751777|P1|Participant Flow|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
506547|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
506548|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
506549|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
506550|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
506551|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
506552|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
506553|NCT00751777|E2|Reported Event|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
506554|NCT00751777|E1|Reported Event|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
506555|NCT00751790|B1|Baseline|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
506556|NCT00751790|P1|Participant Flow|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
506557|NCT00751790|O1|Outcome|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
506558|NCT00751790|E1|Reported Event|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
506559|NCT00751881|B4|Baseline|Total|Total of all reporting groups
506560|NCT00751881|B3|Baseline|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506561|NCT00751881|B2|Baseline|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506562|NCT00751881|B1|Baseline|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506563|NCT00751881|P3|Participant Flow|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506564|NCT00751881|P2|Participant Flow|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506565|NCT00751881|P1|Participant Flow|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.
508464|NCT00758459|O1|Outcome|AZD1236|AZD1236
506569|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506570|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506571|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506572|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506573|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506574|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506575|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506576|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506577|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506578|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
506579|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
506580|NCT00751881|O1|Outcome|Placebo|Placebo once daily
506581|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
506582|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
506583|NCT00751881|O1|Outcome|Placebo|Placebo once daily
506584|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
506585|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
506586|NCT00751881|O1|Outcome|Placebo|Placebo once daily
506587|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
506588|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
506589|NCT00751881|O1|Outcome|Placebo|Placebo once daily
506590|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
506591|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
506592|NCT00751881|O1|Outcome|Placebo|Placebo once daily
506593|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
506594|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
506595|NCT00751881|O1|Outcome|Placebo|Placebo once daily
506596|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
506597|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
506598|NCT00751881|O1|Outcome|Placebo|Placebo once daily
506599|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
506600|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
506601|NCT00751881|O1|Outcome|Placebo|Placebo once daily
506602|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
506603|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
506604|NCT00751881|O1|Outcome|Placebo|Placebo once daily
506605|NCT00751881|E6|Reported Event|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506606|NCT00751881|E5|Reported Event|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
506607|NCT00751881|E4|Reported Event|Placebo / 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily
506608|NCT00751881|E3|Reported Event|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
506609|NCT00751881|E2|Reported Event|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
506610|NCT00751881|E1|Reported Event|Placebo|Placebo once daily
506611|NCT00751933|B1|Baseline|All Arms|Three patients entered the study, one man, two women. Age 24-41 years. The study was terminated due to lack of patients for inclusion.
506612|NCT00751933|P4|Participant Flow|Vaccine and Oats 1|"Vaccination with Vivotif and Dukoral + dietary supplement with oats.
Vaccine Vivotif + Vaccine Dukoral + oats: Vivotif 1 capsule at study day 1,3,5 and 7.
Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.
One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months."
506613|NCT00751933|P3|Participant Flow|Placebo 4|"Placebo instead of vaccines No dietary supplement
Placebo: Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine"
506614|NCT00751933|P2|Participant Flow|Oats Supplement 3|"Dietary supplement with oats
Oats: One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months."
506615|NCT00751933|P1|Participant Flow|Vaccine Arm 2|"Vaccination with Vivotif and Dukoral
Vaccine Vivotif + Vaccine Dukoral: Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14."
506616|NCT00751933|O1|Outcome|All Arms|No patient completed the study, therefore we have no information to report.
506617|NCT00751933|O1|Outcome|All Arms|No patient completed the study, therefore we have no information to report.
506618|NCT00751933|E1|Reported Event|All Arms|No adverse effects were recorded.
506619|NCT00751972|B3|Baseline|Total|Total of all reporting groups
506620|NCT00751972|B2|Baseline|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS (NCT00119834) during the same enrollment period.
506621|NCT00751972|B1|Baseline|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
506622|NCT00751972|P2|Participant Flow|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
506623|NCT00751972|P1|Participant Flow|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
506625|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
507597|NCT00754130|B7|Baseline|Total|Total of all reporting groups
506629|NCT00751972|O2|Outcome|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
506630|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
506631|NCT00751972|O2|Outcome|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
506632|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
506633|NCT00751972|E1|Reported Event|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
506634|NCT00751998|B1|Baseline|Arm 1|Test of SpyGlass device
506635|NCT00751998|P1|Participant Flow|Arm 1|Test of SpyGlass device
506636|NCT00751998|O1|Outcome|Arm 1|Test of SpyGlass device
506637|NCT00751998|E1|Reported Event|Arm 1|Test of SpyGlass device
506638|NCT00752089|B1|Baseline|Overall Study Participants|All randomized participants who received all four treatments NaF/ KNO3/ 2% isopentane Dentifrice, NaF/KNO3/ 0% isopentane Dentifrice, NaF Dentifrice, and placebo were included in the baseline assessment.
506639|NCT00752089|P1|Participant Flow|Overall Study|This was a single-center, examiner blind, randomized, controlled, four treatment cross-over study. Participants have used each study product twice per day for two weeks and participated in each of the four treatment periods.
506640|NCT00752089|O4|Outcome|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
506641|NCT00752089|O3|Outcome|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
506642|NCT00752089|O2|Outcome|NaF/ KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
506643|NCT00752089|O1|Outcome|NaF/ KNO3/ 2% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
506644|NCT00752089|O4|Outcome|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
506645|NCT00752089|O3|Outcome|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
506646|NCT00752089|O2|Outcome|NaF/KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
506647|NCT00752089|O1|Outcome|NaF/ KNO3/ 2% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
506648|NCT00752089|E4|Reported Event|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
506649|NCT00752089|E3|Reported Event|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
506650|NCT00752089|E2|Reported Event|NaF/KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
506651|NCT00752089|E1|Reported Event|NaF/ KNO3/ 2 % Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
506652|NCT00752128|B1|Baseline|Resolute Drug-Eluting Stent|
506653|NCT00752128|P1|Participant Flow|Resolute Drug-Eluting Stent|
506654|NCT00752128|O1|Outcome|Overall Stent Thrombosis (Definite and Probable-ARC)|Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition
506655|NCT00752128|O1|Outcome|Cardiac Death or Target Vessel MI|Percentage of participants that had either Cardiac Death or Myocardial Infarction (not clearly attributable to a non-target vessel)
506656|NCT00752128|E1|Reported Event|Resolute Drug-Eluting Stent|
506657|NCT00752232|B8|Baseline|Total|Total of all reporting groups
506658|NCT00752232|B7|Baseline|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506659|NCT00752232|B6|Baseline|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506660|NCT00752232|B5|Baseline|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506661|NCT00752232|B4|Baseline|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
506662|NCT00752232|B3|Baseline|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day
1, month 3, 6, 9 and 12"
506663|NCT00752232|B2|Baseline|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506664|NCT00752232|B1|Baseline|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506665|NCT00752232|P7|Participant Flow|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506995|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss
Weight Loss: 6 months of weight loss"
506666|NCT00752232|P6|Participant Flow|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506667|NCT00752232|P5|Participant Flow|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506790|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506668|NCT00752232|P4|Participant Flow|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
506669|NCT00752232|P3|Participant Flow|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day
1, month 3, 6, 9 and 12"
506670|NCT00752232|P2|Participant Flow|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506671|NCT00752232|P1|Participant Flow|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506672|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506673|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506674|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506675|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
506676|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506677|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506678|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506679|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506680|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506681|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506682|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
506683|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506684|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506685|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506686|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506687|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506688|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506689|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
506690|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506691|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506692|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506693|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506694|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506695|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506696|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
506697|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506698|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506699|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506700|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506701|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506702|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506703|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
506704|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506705|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506706|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506707|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506708|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506709|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506710|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
506711|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506712|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506713|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506714|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506715|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506716|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506717|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
506718|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506719|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506720|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506721|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506722|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506723|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506724|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
506725|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12
506726|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506727|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506728|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506729|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506730|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506731|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
506732|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12
506733|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506734|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506735|NCT00752232|E7|Reported Event|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
506736|NCT00752232|E6|Reported Event|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506737|NCT00752232|E5|Reported Event|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
506738|NCT00752232|E4|Reported Event|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 3, 6, 9 and 12
506739|NCT00752232|E3|Reported Event|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day
1, month 3, 6, 9 and 12"
506740|NCT00752232|E2|Reported Event|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
506791|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
578592|NCT00939107|B3|Baseline|Total|Total of all reporting groups
506741|NCT00752232|E1|Reported Event|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
506742|NCT00752609|B3|Baseline|Total|Total of all reporting groups
506743|NCT00752609|B2|Baseline|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506744|NCT00752609|B1|Baseline|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506745|NCT00752609|P2|Participant Flow|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506746|NCT00752609|P1|Participant Flow|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506747|NCT00752609|O3|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received 0.04 to 0.16 mg/kg Peginesatide subcutaneous injection, once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506748|NCT00752609|O2|Outcome|SC Peginesatide - On Dialysis|Participants on dialysis received 0.04 to 0.16 mg/kg Peginesatide subcutaneous (SC) injection, once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506749|NCT00752609|O1|Outcome|IV Peginesatide - On Dialysis|Participants on dialysis received 0.04 to 0.16 mg/kg Peginesatide intravenous (IV) injection once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506750|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506751|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506752|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506753|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506754|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506755|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506756|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506757|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506758|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506759|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506792|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506760|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506761|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506762|NCT00752609|E2|Reported Event|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506763|NCT00752609|E1|Reported Event|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506764|NCT00752622|B1|Baseline|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
506765|NCT00752622|P1|Participant Flow|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
506766|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
506767|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
506768|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
506769|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
506770|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
506771|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
506772|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
506773|NCT00752622|E2|Reported Event|Infliximab 5 mg/kg Then Randomized|Infliximab 5 mg/kg IV at weeks 0, 2 and 6 during the induction phase as well as every 8 weeks during the observational phase. Participants were then randomized to receive 5 mg/kg every 6 weeks (shortened interval group) or 7 mg/kg every 8 weeks (increased dose group) at entry into the interventional phase. This reporting group included 3 participants randomized into the shortened interval group and 5 participants randomized into the increased dose group.
506774|NCT00752622|E1|Reported Event|Infliximab 5 mg/kg Then Not Randomized|Infliximab 5 mg/kg IV at weeks 0, 2 and 6 during the induction phase as well as every 8 weeks during the observational phase. Participants who were further randomized into the interventional phase are not included in this reporting group; therefore, of the 100 enrolled participants, 92 participants were included in this safety reporting group.
506775|NCT00752726|B3|Baseline|Total|Total of all reporting groups
506776|NCT00752726|B2|Baseline|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day. ITT population was considered for baseline measures.
506777|NCT00752726|B1|Baseline|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day. Intent-to-treat (ITT) population was considered for baseline measures.
506778|NCT00752726|P2|Participant Flow|Placebo|Placebo to match orlistat 60 mg capsules taken orally with meals 3 times per day
506779|NCT00752726|P1|Participant Flow|Orlistat 60 Milligram (mg)|Orlistat 60 mg capsules taken orally with meals 3 times per day
506780|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506781|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
506782|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506783|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
506784|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506785|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
506786|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506787|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
506788|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506789|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
506793|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
506794|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506795|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
506796|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506797|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
506798|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506799|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
506800|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506801|NCT00752726|E2|Reported Event|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
506802|NCT00752726|E1|Reported Event|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
506803|NCT00752791|B1|Baseline|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506804|NCT00752791|P1|Participant Flow|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506805|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506806|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506807|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506808|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506809|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506810|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506811|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506812|NCT00752791|E1|Reported Event|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
506813|NCT00752895|B3|Baseline|Total|Total of all reporting groups
506814|NCT00752895|B2|Baseline|Arm II - Placebo|"Patients receive oral placebo twice daily.
Placebo: Given orally"
506815|NCT00752895|B1|Baseline|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally"
506816|NCT00752895|P2|Participant Flow|Arm II - Placebo|"Patients receive oral placebo twice daily.
Placebo: Given orally"
506817|NCT00752895|P1|Participant Flow|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally"
506818|NCT00752895|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo twice daily.
Placebo: Given orally"
506819|NCT00752895|O1|Outcome|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally"
506820|NCT00752895|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo twice daily.
Placebo: Given orally"
506821|NCT00752895|O1|Outcome|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally"
506822|NCT00752895|E2|Reported Event|Arm II - Placebo|"Patients receive oral placebo twice daily.
Placebo: Given orally"
506823|NCT00752895|E1|Reported Event|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.
American ginseng: Given orally"
506824|NCT00752973|B1|Baseline|MALG Treatment Arm|"MALG treatment
MALG (malathion) Treatment: MALG applied for 30 minutes"
506825|NCT00752973|P1|Participant Flow|Malathion Gel 0.5% Treatment Arm|"Malathion Gel 0.5% treatment
MALG (Malathion Gel 0.5%) Treatment: MALG applied for 30 minutes"
506826|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment
MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes
Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
506996|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training
Aerobic Exercise Training: 6 months of aerobic exercise training"
508465|NCT00758459|O2|Outcome|Placebo|Placebo
506853|NCT00752986|E3|Reported Event|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
506827|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment
MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes
Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator."
506828|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment
MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes
Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
506829|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment
MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes
Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
506830|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment
MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes
Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
506831|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment
MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes
A subject had out of range (low) RBC cholinesterase value 1 h post treatment. This value was considered to be not clinically significant by the investigator."
506832|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment
MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes
Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator."
506833|NCT00752973|E1|Reported Event|MALG Treatment Arm|"MALG treatment
MALG (malathion) Treatment: MALG applied for 30 minutes"
506834|NCT00752986|B4|Baseline|Total|Total of all reporting groups
506835|NCT00752986|B3|Baseline|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
506836|NCT00752986|B2|Baseline|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506837|NCT00752986|B1|Baseline|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506838|NCT00752986|P3|Participant Flow|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
506839|NCT00752986|P2|Participant Flow|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506840|NCT00752986|P1|Participant Flow|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506841|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
506842|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506843|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506844|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
506845|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506846|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506847|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
506848|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506849|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506850|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
506851|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506852|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506854|NCT00752986|E2|Reported Event|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506855|NCT00752986|E1|Reported Event|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
506856|NCT00753012|B3|Baseline|Total|Total of all reporting groups
506857|NCT00753012|B2|Baseline|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
506858|NCT00753012|B1|Baseline|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
506859|NCT00753012|P2|Participant Flow|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
506860|NCT00753012|P1|Participant Flow|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
506861|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|
506862|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
506863|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|
506864|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
506865|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
506866|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
506867|NCT00753012|E2|Reported Event|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
506868|NCT00753012|E1|Reported Event|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
506869|NCT00753142|B4|Baseline|Total|Total of all reporting groups
506870|NCT00753142|B3|Baseline|Nondiabetic Control Subjects|overweight/obese subjects without diabetes
506871|NCT00753142|B2|Baseline|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
506872|NCT00753142|B1|Baseline|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
506873|NCT00753142|P3|Participant Flow|Nondiabetic Control Subjects|overweight/obese subjects without diabetes
506874|NCT00753142|P2|Participant Flow|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
506875|NCT00753142|P1|Participant Flow|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
506876|NCT00753142|O3|Outcome|Nondiabetic Control Subjects|Overweight/obese subjects without diabetes
506877|NCT00753142|O2|Outcome|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
506878|NCT00753142|O1|Outcome|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
506879|NCT00753142|E3|Reported Event|Nondiabetic Control Subjects|Overweight/obese subjects without diabetes
506880|NCT00753142|E2|Reported Event|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
506881|NCT00753142|E1|Reported Event|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
506882|NCT00753220|B1|Baseline|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy
VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.
Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
506883|NCT00753220|P1|Participant Flow|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy
VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.
Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
506884|NCT00753220|O1|Outcome|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy
VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.
Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
506885|NCT00753220|E1|Reported Event|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy
VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.
Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
506886|NCT00753272|B3|Baseline|Total|Total of all reporting groups
506887|NCT00753272|B2|Baseline|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506888|NCT00753272|B1|Baseline|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506997|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss
Weight Loss: 6 months of weight loss"
508466|NCT00758459|O1|Outcome|AZD1236|AZD1236
506889|NCT00753272|P2|Participant Flow|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506890|NCT00753272|P1|Participant Flow|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506891|NCT00753272|O5|Outcome|FluNG Lot 3 Group|subjects received 1 dose of FluNG vaccine Lot 3 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 3. The vaccine was administered intramuscularly in the non-dominant deltoid.
506892|NCT00753272|O4|Outcome|FluNG Lot 2 Group|subjects received 1 dose of FluNG vaccine Lot 2 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 2. The vaccine was administered intramuscularly in the non-dominant deltoid.
506893|NCT00753272|O3|Outcome|FluNG Lot 1 Group|subjects received 1 dose of FluNG vaccine Lot 1 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 1. The vaccine was administered intramuscularly in the non-dominant deltoid.
506894|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506895|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506896|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506897|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506898|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506899|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506900|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506901|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506902|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506903|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506904|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506905|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506906|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506907|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506908|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506909|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506910|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506911|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506912|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506913|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506914|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506915|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506916|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506917|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506918|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506919|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506920|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506921|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506922|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506923|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506924|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506925|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506926|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506927|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506928|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506929|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506930|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506931|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506932|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506933|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506934|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506935|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506936|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506937|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506938|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506939|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506940|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506941|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506942|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506943|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506944|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
508467|NCT00758459|O2|Outcome|Placebo|Placebo
506945|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506946|NCT00753272|O5|Outcome|FluNG Lot 3 Group|subjects received 1 dose of FluNG vaccine Lot 3 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 3. The vaccine was administered intramuscularly in the non-dominant deltoid.
506947|NCT00753272|O4|Outcome|FluNG Lot 2 Group|subjects received 1 dose of FluNG vaccine Lot 2 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 2. The vaccine was administered intramuscularly in the non-dominant deltoid.
506948|NCT00753272|O3|Outcome|FluNG Lot 1 Group|subjects received 1 dose of FluNG vaccine Lot 1 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 1. The vaccine was administered intramuscularly in the non-dominant deltoid.
506949|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506950|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506951|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506952|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506953|NCT00753272|E2|Reported Event|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506954|NCT00753272|E1|Reported Event|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
506955|NCT00753298|B3|Baseline|Total|Total of all reporting groups
506956|NCT00753298|B2|Baseline|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
506957|NCT00753298|B1|Baseline|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
506958|NCT00753298|P2|Participant Flow|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
506959|NCT00753298|P1|Participant Flow|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
506960|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
506961|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
506962|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
506963|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
506964|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
506965|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
506966|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
506967|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
506968|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
506969|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
506970|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
506971|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
506972|NCT00753298|E2|Reported Event|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
506973|NCT00753298|E1|Reported Event|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
506974|NCT00753337|B1|Baseline|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
506975|NCT00753337|P1|Participant Flow|Assurant Cobalt Iliac Stent|Cobalt stent implanted using standard percutaneous intervention technique.
506976|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting.
506977|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
506978|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
506979|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
506980|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
506981|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
506982|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
506983|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
506984|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
506985|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
506986|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
506987|NCT00753337|E1|Reported Event|Assurant Cobalt Iliac Stent|Treatment with Iliac stenting system
506988|NCT00753363|B3|Baseline|Total|Total of all reporting groups
506989|NCT00753363|B2|Baseline|Arm 2|"6 months of weight loss
Weight Loss: 6 months of weight loss"
506990|NCT00753363|B1|Baseline|Arm 1|"6 months of aerobic exercise training
Aerobic Exercise Training: 6 months of aerobic exercise training"
506991|NCT00753363|P2|Participant Flow|Arm 2|"6 months of weight loss
Weight Loss: 6 months of weight loss"
506992|NCT00753363|P1|Participant Flow|Arm 1|"6 months of aerobic exercise training
Aerobic Exercise Training: 6 months of aerobic exercise training"
506993|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss
Weight Loss: 6 months of weight loss"
506994|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training
Aerobic Exercise Training: 6 months of aerobic exercise training"
506998|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training
Aerobic Exercise Training: 6 months of aerobic exercise training"
506999|NCT00753363|E2|Reported Event|Arm 2|"6 months of weight loss
Weight Loss: 6 months of weight loss"
507000|NCT00753363|E1|Reported Event|Arm 1|"6 months of aerobic exercise training
Aerobic Exercise Training: 6 months of aerobic exercise training"
507001|NCT00753415|B6|Baseline|Total|Total of all reporting groups
507002|NCT00753415|B5|Baseline|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507003|NCT00753415|B4|Baseline|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507004|NCT00753415|B3|Baseline|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
507005|NCT00753415|B2|Baseline|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
507006|NCT00753415|B1|Baseline|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
507007|NCT00753415|P10|Participant Flow|Part B: V934 HD(5)+V934 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507008|NCT00753415|P9|Participant Flow|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507009|NCT00753415|P8|Participant Flow|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507010|NCT00753415|P7|Participant Flow|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507011|NCT00753415|P6|Participant Flow|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.
507012|NCT00753415|P5|Participant Flow|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507013|NCT00753415|P4|Participant Flow|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507014|NCT00753415|P3|Participant Flow|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.
507015|NCT00753415|P2|Participant Flow|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
507016|NCT00753415|P1|Participant Flow|Part A: V935 LD|Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
507017|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507018|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507019|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, V934-EP booster was administered, 1 given every 2 weeks for 3 doses.
507020|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507021|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507022|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507023|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507024|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
507025|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
507026|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
507027|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507028|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507029|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
508468|NCT00758459|O1|Outcome|AZD1236|AZD1236
507030|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507031|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507032|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507033|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507034|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
507035|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
507036|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
507037|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507038|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507039|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507040|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507041|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507042|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507043|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507044|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
507045|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
507046|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
507047|NCT00753415|E10|Reported Event|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507048|NCT00753415|E9|Reported Event|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507049|NCT00753415|E8|Reported Event|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507050|NCT00753415|E7|Reported Event|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507051|NCT00753415|E6|Reported Event|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
507052|NCT00753415|E5|Reported Event|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507053|NCT00753415|E4|Reported Event|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
507054|NCT00753415|E3|Reported Event|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
507055|NCT00753415|E2|Reported Event|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
507056|NCT00753415|E1|Reported Event|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
507057|NCT00753454|B1|Baseline|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507127|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507128|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507129|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507134|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507135|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507058|NCT00753454|P1|Participant Flow|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507059|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507060|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507061|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507062|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507063|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507064|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507065|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507066|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507067|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507068|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507069|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507070|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507071|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507130|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507131|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
508469|NCT00758459|O2|Outcome|Placebo|Placebo
507072|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507073|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507074|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507075|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507076|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507077|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507078|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507079|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507080|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507081|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507082|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507083|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507084|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507085|NCT00753454|E1|Reported Event|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
507086|NCT00753506|B3|Baseline|Total|Total of all reporting groups
507132|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507133|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507087|NCT00753506|B2|Baseline|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
507088|NCT00753506|B1|Baseline|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
507089|NCT00753506|P2|Participant Flow|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
507090|NCT00753506|P1|Participant Flow|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
507091|NCT00753506|O2|Outcome|Placebo|100 mg artemisinin identical placebo capsule taken twice per day.
507092|NCT00753506|O1|Outcome|Artemisinin|100 mg capsule of artemisinin taken twice per day.
507093|NCT00753506|E2|Reported Event|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
507094|NCT00753506|E1|Reported Event|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
507095|NCT00753519|B3|Baseline|Total|Total of all reporting groups
507096|NCT00753519|B2|Baseline|Sham iTBS|Sham iTBS
507097|NCT00753519|B1|Baseline|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
507098|NCT00753519|P2|Participant Flow|Sham iTBS|Sham iTBS
507099|NCT00753519|P1|Participant Flow|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
507100|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
507101|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
507102|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
507103|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
507104|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
507105|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
507106|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
507107|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
507108|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
507109|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
507110|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
507111|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
507112|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
507113|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
507114|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
507115|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
507116|NCT00753519|E2|Reported Event|Sham iTBS|Sham iTBS
507117|NCT00753519|E1|Reported Event|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
507118|NCT00753545|B3|Baseline|Total|Total of all reporting groups
507119|NCT00753545|B2|Baseline|Placebo bd|olaparib matching placebo oral capsules twice daily
507120|NCT00753545|B1|Baseline|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507121|NCT00753545|P2|Participant Flow|Placebo bd|olaparib matching placebo oral capsules twice daily
507122|NCT00753545|P1|Participant Flow|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507123|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507124|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507125|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507126|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
508470|NCT00758459|O1|Outcome|AZD1236|AZD1236
507136|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507137|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507138|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507139|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507140|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507141|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507142|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507143|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507144|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507145|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507146|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507147|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507148|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507149|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507150|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507151|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507152|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507153|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
507154|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
507155|NCT00753545|E2|Reported Event|Placebo|
507156|NCT00753545|E1|Reported Event|Olaparib 400 mg bd|
507157|NCT00753623|B3|Baseline|Total|Total of all reporting groups
507158|NCT00753623|B2|Baseline|Ramelton Phase I; Placebo Phase II|"In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.
Ramelteon : ramelteon (8 mg)"
507159|NCT00753623|B1|Baseline|Placebo Phase I; Ramelteon Phase II|"In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.
Ramelteon : ramelteon (8 mg)"
507160|NCT00753623|P2|Participant Flow|Ramelton Phase I; Placebo Phase II|"In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.
Ramelteon : ramelteon (8 mg)"
507161|NCT00753623|P1|Participant Flow|Placebo Phase I; Ramelteon Phase II|"In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.
Ramelteon : ramelteon (8 mg)"
507162|NCT00753623|O2|Outcome|Placebo|Participants who received placebo medication during the first or last 2 weeks of the study.
507163|NCT00753623|O1|Outcome|Ramelteon|Participants who received Ramelteon 8 mg during the first or last 2 weeks of the study.
507164|NCT00753623|E2|Reported Event|Placebo|Participants who received placebo medication during the first or last 2 weeks of the study.
507165|NCT00753623|E1|Reported Event|Ramelteon|Participants who received Ramelteon 8 mg during the first or last 2 weeks of the study.
507166|NCT00753636|B1|Baseline|Isradipine 20mg, 15mg, 10mg or 5 mg|
507167|NCT00753636|P1|Participant Flow|Isradipine 20mg, 15mg, 10mg or 5 mg|
507168|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
507169|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
507170|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
507171|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
507172|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
507173|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
507174|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
507175|NCT00753636|E1|Reported Event|Isradipine 20mg, 15mg, 10mg or 5 mg|
507176|NCT00753649|B3|Baseline|Total|Total of all reporting groups
507177|NCT00753649|B2|Baseline|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507178|NCT00753649|B1|Baseline|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507179|NCT00753649|P2|Participant Flow|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507180|NCT00753649|P1|Participant Flow|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507290|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
508471|NCT00758459|E2|Reported Event|Placebo|Placebo
507291|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
507292|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
507181|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507182|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507183|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507184|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507185|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507186|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507187|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507188|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507189|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507190|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507191|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507192|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507193|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507194|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507240|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507195|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507196|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507197|NCT00753649|E2|Reported Event|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507198|NCT00753649|E1|Reported Event|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
507199|NCT00753675|B4|Baseline|Total|Total of all reporting groups
507200|NCT00753675|B3|Baseline|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
507201|NCT00753675|B2|Baseline|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
507202|NCT00753675|B1|Baseline|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
507203|NCT00753675|P3|Participant Flow|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
507204|NCT00753675|P2|Participant Flow|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
507205|NCT00753675|P1|Participant Flow|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
507206|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
507207|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
507208|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
507209|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
507210|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
507211|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
507212|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
507213|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
507214|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
507283|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
507284|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
507215|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
507216|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
507217|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
507218|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
507219|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
507220|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
507221|NCT00753675|E3|Reported Event|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
507222|NCT00753675|E2|Reported Event|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
507223|NCT00753675|E1|Reported Event|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
507224|NCT00753688|B3|Baseline|Total|Total of all reporting groups
507225|NCT00753688|B2|Baseline|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507226|NCT00753688|B1|Baseline|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507227|NCT00753688|P2|Participant Flow|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507228|NCT00753688|P1|Participant Flow|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507229|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507230|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507231|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507232|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507233|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507234|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507235|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507236|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507237|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507238|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507239|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507241|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507242|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507243|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507244|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507245|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507246|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507247|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507248|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507249|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507250|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507251|NCT00753688|E2|Reported Event|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507252|NCT00753688|E1|Reported Event|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
507253|NCT00753714|B3|Baseline|Total|Total of all reporting groups
507254|NCT00753714|B2|Baseline|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
507255|NCT00753714|B1|Baseline|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
507256|NCT00753714|P2|Participant Flow|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
507257|NCT00753714|P1|Participant Flow|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
507258|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
507259|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
507285|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
507286|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
507287|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
507288|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
507289|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
507260|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
507261|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
507262|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
507263|NCT00753714|O1|Outcome|ZD6474 ( (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
507264|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
507265|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
507266|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
507267|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
507268|NCT00753714|E2|Reported Event|Placebo to Match ZD6474 (Gemcitabine), Vandetanib|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
507269|NCT00753714|E1|Reported Event|ZD6474 (Gemcitabine), Vandetanib|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
507270|NCT00753766|B3|Baseline|Total|Total of all reporting groups
507271|NCT00753766|B2|Baseline|Control|Control group
507272|NCT00753766|B1|Baseline|Intervention|"Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
Multifactorial Intervention: Intervention included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise."
507273|NCT00753766|P2|Participant Flow|Usual Care|Control group
507274|NCT00753766|P1|Participant Flow|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
507275|NCT00753766|O2|Outcome|Usual Care|Control group
507276|NCT00753766|O1|Outcome|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
507277|NCT00753766|O2|Outcome|Usual Care|Control group
507278|NCT00753766|O1|Outcome|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
507279|NCT00753766|E2|Reported Event|Usual Care|Control group
507280|NCT00753766|E1|Reported Event|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
507281|NCT00753896|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
507282|NCT00753896|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
507296|NCT00753922|B4|Baseline|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
507297|NCT00753922|B3|Baseline|Revision Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
507298|NCT00753922|B2|Baseline|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
Asymmetry is one or more of the following conditions:
One cup size difference in breast size.
The need to differentially pad one bra cup to match the opposite breast size.
Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
507299|NCT00753922|B1|Baseline|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
507300|NCT00753922|P4|Participant Flow|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
507301|NCT00753922|P3|Participant Flow|Revision Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
507302|NCT00753922|P2|Participant Flow|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
Asymmetry is one or more of the following conditions:
One cup size difference in breast size.
The need to differentially pad one bra cup to match the opposite breast size.
Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
507303|NCT00753922|P1|Participant Flow|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
507304|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
507305|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
507306|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
507307|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
507308|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
507309|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
507310|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
507311|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
507312|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
507313|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
507314|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
507315|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
507316|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
507317|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
507318|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
507319|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
507320|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
507321|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
507322|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
507323|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
507324|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
507325|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
507326|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
507327|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
507328|NCT00753922|E4|Reported Event|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
507329|NCT00753922|E3|Reported Event|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
507330|NCT00753922|E2|Reported Event|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
Asymmetry is one or more of the following conditions:
One cup size difference in breast size.
The need to differentially pad one bra cup to match the opposite breast size.
Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
507331|NCT00753922|E1|Reported Event|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
507332|NCT00753948|B4|Baseline|Total|Total of all reporting groups
507333|NCT00753948|B3|Baseline|Healthy Controls|"Neurologically intact, otherwise healthy, age-matched control
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507334|NCT00753948|B2|Baseline|Mild Asthma|"Individuals with diagnosed mild asthma
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507335|NCT00753948|B1|Baseline|Chronic Tetraplegia|"Individuals with chronic tetraplegia
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507336|NCT00753948|P3|Participant Flow|Healthy Control|"Neurologically intact, otherwise healthy, age-matched control
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507337|NCT00753948|P2|Participant Flow|Mild Asthma|"Individuals with diagnosed mild asthma
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507338|NCT00753948|P1|Participant Flow|Chronic Tetraplegia|"Individuals with chronic tetraplegia
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507339|NCT00753948|O3|Outcome|Arm 3|"Neurologically intact, otherwise healthy, age-matched control
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507340|NCT00753948|O2|Outcome|Arm 2|"Individuals with diagnosed mild asthma
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507341|NCT00753948|O1|Outcome|Arm 1|"Individuals with chronic tetraplegia
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507342|NCT00753948|E3|Reported Event|Arm 3|"Neurologically intact, otherwise healthy, age-matched control
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507343|NCT00753948|E2|Reported Event|Arm 2|"Individuals with diagnosed mild asthma
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507344|NCT00753948|E1|Reported Event|Arm 1|"Individuals with chronic tetraplegia
N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
507345|NCT00754013|B3|Baseline|Total|Total of all reporting groups
507346|NCT00754013|B2|Baseline|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
507347|NCT00754013|B1|Baseline|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
507348|NCT00754013|P2|Participant Flow|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
507349|NCT00754013|P1|Participant Flow|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
507350|NCT00754013|O2|Outcome|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
507351|NCT00754013|O1|Outcome|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
507352|NCT00754013|O2|Outcome|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
507353|NCT00754013|O1|Outcome|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
507649|NCT00754156|B3|Baseline|Total|Total of all reporting groups
507354|NCT00754013|E2|Reported Event|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
507355|NCT00754013|E1|Reported Event|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
507356|NCT00754065|B3|Baseline|Total|Total of all reporting groups
507357|NCT00754065|B2|Baseline|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507358|NCT00754065|B1|Baseline|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507359|NCT00754065|P2|Participant Flow|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507360|NCT00754065|P1|Participant Flow|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507361|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507362|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507363|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507364|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507365|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507366|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507367|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507368|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507369|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507370|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507371|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507372|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507373|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507374|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507375|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507376|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507377|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507378|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507379|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507380|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
508269|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol
Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
507381|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507382|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507383|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507384|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507385|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507386|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507387|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507388|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507389|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507390|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507391|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507392|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507393|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507394|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507395|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507396|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507397|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507398|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507399|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507400|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507401|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507402|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507403|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507650|NCT00754156|B2|Baseline|V.A.C. or ABThera|V.A.C. or ABThera Therapy alone
507404|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507405|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507406|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507407|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507408|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507409|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507410|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507411|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507412|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507413|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507414|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507415|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507416|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507417|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507418|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507419|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507420|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507421|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507422|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507423|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507424|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507425|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507426|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507427|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507651|NCT00754156|B1|Baseline|1 ABRA Plus V.A.C or ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C. or AbThera Therapy
507428|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507429|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507430|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507431|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507432|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507433|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507434|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507435|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507436|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507437|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507438|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507439|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507440|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507441|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507442|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507443|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507444|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507445|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507446|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507447|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507448|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507449|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507450|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507451|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507652|NCT00754156|P2|Participant Flow|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
507452|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507453|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507454|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507455|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507456|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507457|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507458|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507459|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507460|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507461|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507462|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507463|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507464|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507465|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507466|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507467|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507468|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507469|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507470|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507471|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507472|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507473|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507474|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507475|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507783|NCT00748579|O1|Outcome|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
507476|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507477|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507478|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507479|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507480|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507481|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507482|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507483|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507484|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507485|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507486|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507487|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507488|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507489|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507490|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507491|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507492|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507493|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507494|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507495|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507496|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507497|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507498|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507499|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507784|NCT00748579|E2|Reported Event|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
507500|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507501|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507502|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507503|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507504|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507505|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507506|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507507|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507508|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507509|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507510|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507511|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507512|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507513|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507514|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507515|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507516|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507517|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507518|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507519|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507520|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507521|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507522|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507523|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507785|NCT00748579|E1|Reported Event|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
507524|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507525|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507526|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507527|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507528|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507529|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507530|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507531|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507532|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507533|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507534|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507535|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507536|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507537|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507538|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507539|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507540|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507541|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507542|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507543|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507544|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507545|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507546|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507547|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507786|NCT00748657|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
507548|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507549|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507550|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507551|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507552|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507553|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507554|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507555|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507556|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507557|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507558|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507559|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507560|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507561|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507562|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507563|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507564|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507565|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507566|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507567|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507568|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507569|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507570|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507571|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507787|NCT00748657|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
507572|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507573|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507574|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507575|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507576|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507577|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507578|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507579|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507580|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507581|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507582|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507583|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507584|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507585|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507586|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507587|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507588|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507589|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507590|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507591|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507592|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507593|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507594|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
507595|NCT00754065|E2|Reported Event|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
508190|NCT00757627|E1|Reported Event|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
507596|NCT00754065|E1|Reported Event|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles(treatment encapsulated)
507598|NCT00754130|B6|Baseline|MK-0941 10mg/MK-0941 40mg|Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
507599|NCT00754130|B5|Baseline|MK-0941 10mg/Placebo|Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
507600|NCT00754130|B4|Baseline|Placebo/MK-0941 40mg|Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
507601|NCT00754130|B3|Baseline|MK-0941 5mg/MK-0941 20mg|Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
507602|NCT00754130|B2|Baseline|MK-0941 5mg/Placebo|Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
507603|NCT00754130|B1|Baseline|Placebo/MK-0941 20mg|Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
507604|NCT00754130|P6|Participant Flow|MK-0941 10mg/MK-0941 40mg|Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
507605|NCT00754130|P5|Participant Flow|MK-0941 10mg/Placebo|Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
507606|NCT00754130|P4|Participant Flow|Placebo/MK-0941 40mg|Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
507607|NCT00754130|P3|Participant Flow|MK-0941 5mg/MK-0941 20mg|Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
507608|NCT00754130|P2|Participant Flow|MK-0941 5mg/Placebo|Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
507609|NCT00754130|P1|Participant Flow|Placebo/MK-0941 20mg|Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
507610|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
507611|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
507612|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
507613|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
507614|NCT00754130|O5|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
507615|NCT00754130|O4|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
507616|NCT00754130|O3|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
507617|NCT00754130|O2|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
507618|NCT00754130|O1|Outcome|Placebo|Participants receiving Placebo doses three times daily
507619|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
507620|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
507621|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
507622|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
507623|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
507624|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
507625|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
507626|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
507627|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
507628|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
507629|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
507630|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
507631|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
507632|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
507633|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
507634|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
507635|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
507636|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
507637|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
507638|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
507639|NCT00754130|O5|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
507640|NCT00754130|O4|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
507641|NCT00754130|O3|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
507642|NCT00754130|O2|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
507643|NCT00754130|O1|Outcome|Placebo|Participants receiving Placebo doses three times daily
507644|NCT00754130|E5|Reported Event|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
507645|NCT00754130|E4|Reported Event|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
507646|NCT00754130|E3|Reported Event|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
507647|NCT00754130|E2|Reported Event|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
507648|NCT00754130|E1|Reported Event|Placebo|Participants receiving Placebo doses three times daily
507653|NCT00754156|P1|Participant Flow|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
507654|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
508576|NCT00758550|B1|Baseline|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
507655|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
507656|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
507657|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
507658|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
507659|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
507660|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
507661|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
507662|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|V.A.C. or ABThera V.A.C. Therapy alone
507663|NCT00754156|O1|Outcome|1 ABRA Plus V.A.C. or ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C. or ABThera V.A.C. Therapy
507664|NCT00754156|O2|Outcome|2 ABThera|V.A.C. or ABThera V.A.C. Therapy alone
507665|NCT00754156|O1|Outcome|1 ABRA Plus ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C or ABThera V.A.C. Therapy
507666|NCT00754156|O2|Outcome|2 ABThera|ABThera V.A.C. Therapy alone
507667|NCT00754156|O1|Outcome|1 ABRA Plus ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
507668|NCT00754156|E2|Reported Event|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
507669|NCT00754156|E1|Reported Event|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
507670|NCT00754234|B1|Baseline|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
507671|NCT00754234|P1|Participant Flow|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
507672|NCT00754234|O1|Outcome|MyPyramid Menu|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
507673|NCT00754234|E1|Reported Event|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
507674|NCT00748189|B3|Baseline|Total|Total of all reporting groups
507675|NCT00748189|B2|Baseline|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507676|NCT00748189|B1|Baseline|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507677|NCT00748189|P2|Participant Flow|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507678|NCT00748189|P1|Participant Flow|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507679|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507680|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507681|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507682|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507683|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507684|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507685|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507686|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507708|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507687|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507688|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507689|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507690|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507691|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507692|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507693|NCT00748189|O2|Outcome|Study LEUA1001: Chlorambucil|Participants with CLL, Non-Hodgkin’s lymphoma or other refractory malignancies received three different formulations of a 0.2 mg/kilogram(kg) chlorambucil tablet orally with a two-day interval between drug administration.
507694|NCT00748189|O1|Outcome|Study OMB110911: Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507695|NCT00748189|O2|Outcome|Study LEUA1001: Chlorambucil|Participants with CLL, Non-Hodgkin’s lymphoma or other refractory malignancies received three different formulations of a 0.2 mg/kilogram(kg) chlorambucil tablet orally with a two-day interval between drug administration.
507696|NCT00748189|O1|Outcome|Study OMB110911: Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507697|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
507698|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
507699|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
507700|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
507701|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
507702|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
507703|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
507704|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
507705|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
507706|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
507707|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
508191|NCT00757666|B3|Baseline|Total|Total of all reporting groups
507709|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507710|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507711|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507712|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507713|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507714|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507715|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507716|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507717|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507718|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507719|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507720|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507721|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507722|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507723|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507724|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507725|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507726|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507727|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507788|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
507728|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507729|NCT00748189|E2|Reported Event|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507730|NCT00748189|E1|Reported Event|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
507731|NCT00748241|B1|Baseline|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
507732|NCT00748241|P1|Participant Flow|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
507733|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
507734|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
507735|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
507736|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
507737|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
507738|NCT00748241|E1|Reported Event|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
507739|NCT00748553|B3|Baseline|Total|Total of all reporting groups
507740|NCT00748553|B2|Baseline|Phase I|"Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle"
507741|NCT00748553|B1|Baseline|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
507742|NCT00748553|P2|Participant Flow|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
507743|NCT00748553|P1|Participant Flow|Phase 1|"Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle"
507744|NCT00748553|O1|Outcome|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
507745|NCT00748553|O1|Outcome|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
507746|NCT00748553|O1|Outcome|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
507747|NCT00748553|O1|Outcome|Phase 1|"Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle"
507748|NCT00748553|E1|Reported Event|Phase I and II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
507749|NCT00748566|B1|Baseline|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507750|NCT00748566|P1|Participant Flow|Ziprasidone|Ziprasidone 40 milligram (mg) capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507751|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507752|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507753|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507754|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507755|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507756|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507757|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507758|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507759|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507760|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507761|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507762|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507763|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507764|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507765|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507766|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507767|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507768|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507769|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507770|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507771|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507772|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507773|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507774|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507775|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507776|NCT00748566|E1|Reported Event|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
507777|NCT00748579|B3|Baseline|Total|Total of all reporting groups
507778|NCT00748579|B2|Baseline|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
507779|NCT00748579|B1|Baseline|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
507780|NCT00748579|P2|Participant Flow|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
507781|NCT00748579|P1|Participant Flow|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
507782|NCT00748579|O2|Outcome|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
507789|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
507790|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
507791|NCT00748657|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
507792|NCT00748709|B1|Baseline|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507793|NCT00748709|P1|Participant Flow|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507794|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507795|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507796|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507797|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507798|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507799|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507800|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507801|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507802|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507803|NCT00748709|E1|Reported Event|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
507804|NCT00754325|B3|Baseline|Total|Total of all reporting groups
507805|NCT00754325|B2|Baseline|Fulvestrant|"Participants in this group received a drug regimen that consisted of fulvestrant only.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
507806|NCT00754325|B1|Baseline|Fulvestrant and Dasatinib|"Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
507807|NCT00754325|P2|Participant Flow|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
507808|NCT00754325|P1|Participant Flow|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
507809|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
507810|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
507811|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
507812|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
507813|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
507814|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
507815|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
508192|NCT00757666|B2|Baseline|Minute Ventilation|Minute ventilation
507837|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
508025|NCT00757588|B1|Baseline|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
507816|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
507817|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
507818|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
507819|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
507820|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
507821|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
507822|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
507823|NCT00754325|E3|Reported Event|Fulvestrant Crossover to Fulvestrant and Dasatinib|"Arm 2b: Participants in this group started on the Fulvestrant only arm and later started receiving a drug regimen that consisted of both fulvestrant and dasatinib. These participants are all inclusive and not limited to Fulvestrant or Fulvestrant and Dasatinib treatment only. The timeframe for when these events occurred were not immediately available and may have been caused by previous exposure to Fulvestrant only (pre-crossover), therefore the events for this patient population are also reported separately.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
507824|NCT00754325|E2|Reported Event|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
507825|NCT00754325|E1|Reported Event|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
507826|NCT00754338|B5|Baseline|Total|Total of all reporting groups
507827|NCT00754338|B4|Baseline|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507828|NCT00754338|B3|Baseline|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507829|NCT00754338|B2|Baseline|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507830|NCT00754338|B1|Baseline|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507831|NCT00754338|P4|Participant Flow|Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
507832|NCT00754338|P3|Participant Flow|Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub)|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
507833|NCT00754338|P2|Participant Flow|Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
507834|NCT00754338|P1|Participant Flow|Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and Alcon RepleniSH™ 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
507835|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507836|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507838|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507839|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507840|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507841|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507842|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507843|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507844|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507845|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507846|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507847|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507848|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507849|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507850|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507851|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507852|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507853|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507854|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507855|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507856|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507857|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group
507858|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507859|NCT00754338|E4|Reported Event|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507860|NCT00754338|E3|Reported Event|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507861|NCT00754338|E2|Reported Event|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
507862|NCT00754338|E1|Reported Event|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
507863|NCT00754377|B3|Baseline|Total|Total of all reporting groups
507864|NCT00754377|B2|Baseline|Comparison Group|Didn't receive intervention
507865|NCT00754377|B1|Baseline|PBLI Curriculum Group|Received PBLI curriculum to evaluate and develop tools.
507866|NCT00754377|P2|Participant Flow|Comparison Group|Alternate rotations and didn't receive intervention
507867|NCT00754377|P1|Participant Flow|PBL Curriculum Group|"To evaluate preliminary data on a PBLI curriculum grounded on QI system projects.
PBLI curriculum comparison: The design is a pre-post comparison of PBLI curriculum participants versus non-participants. Data will come from the closed-ended items on the questionnaire given before the rotation and at the end of the rotation. PBLI curriculum was offered on alternate rotations (residents on alternate month were involved with a different curriculum). Preliminary data is available from 11 blocks, 6 PBLI QI Systems Curriculum blocks (n=50) and 5 comparison blocks (n=42) during the previous academic year. Closed-ended items assessed beliefs about different aspects of Continuous Quality Improvement (CQI) project development and implementation (6 items). In addition, there were 5 short definition items to address knowledge. Finally, content analysis methods will be used to evaluate responses to the open-ended item which asked respondents to develop a project to improve patient care."
507868|NCT00754377|O2|Outcome|Comparison Group|Didn't receive the intervention.
507869|NCT00754377|O1|Outcome|PBLI Curriclum Group|Received the intervention and evaluate and develop PBLI tools
507870|NCT00754377|O2|Outcome|Comparison Group|Didn't receive intervention
507871|NCT00754377|O1|Outcome|PBLI Curriculum Group|Received the intervention and used to evaluate and develop PBLI tools
507872|NCT00754377|E2|Reported Event|Comparison Group|Didn't receive the intervention
507873|NCT00754377|E1|Reported Event|PBLI Curriculum Group|Received the intervention. To evaluate and develop PBLI tools.
508024|NCT00757588|B2|Baseline|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508026|NCT00757588|P2|Participant Flow|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
507874|NCT00754390|B1|Baseline|Entire Study Population|Includes all subjects randomized to the 4 treatments. Treatments were assigned in randomized order so the number of subjects starting the study does not equal the starting number for a given treatment
507875|NCT00754390|P1|Participant Flow|Calcium and Phytate Interactions|Subjects consumed 4 test meals (Moderate Calcium (Ca),Low Phytate; Moderate Ca,High Phytate; High Ca,Low Phytate; High Ca,High Phytate) in random order
507876|NCT00754390|O4|Outcome|High Calcium, High Phytate Diet|Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 1800 milligrams of phytate per day
507877|NCT00754390|O3|Outcome|High Calcium, Low Phytate Diet|Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 440 milligrams of phytate per day
507878|NCT00754390|O2|Outcome|Moderate Calcium, High Phytate Diet|Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 1800 milligrams of phytate per day
507879|NCT00754390|O1|Outcome|Moderate Calcium, Low Phytate Diet|Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 440 milligrams of phytate per day
507880|NCT00754390|E1|Reported Event|Overall Study|Participants consumed 4 dietary treatments in randomized order
507881|NCT00754442|B3|Baseline|Total|Total of all reporting groups
507882|NCT00754442|B2|Baseline|Patient Group|patients with secondary hyperparathyroidism
507883|NCT00754442|B1|Baseline|Controls|controls with normal PTH
507884|NCT00754442|P2|Participant Flow|Patient Group|patients with secondary hyperparathyroidism
507885|NCT00754442|P1|Participant Flow|Controls|controls with normal PTH
507886|NCT00754442|O1|Outcome|Patients|patients with idiopathic secondary hyperparathyroidism
507887|NCT00754442|O2|Outcome|Controls|Controls without secondary hyperparathyroidism
507888|NCT00754442|O1|Outcome|Group 1|"patients with secondary hyperparathyroidism"
507889|NCT00754442|E2|Reported Event|Patient Group|patients with secondary hyperparathyroidism
507890|NCT00754442|E1|Reported Event|Controls|controls with normal PTH
507891|NCT00754468|B3|Baseline|Total|Total of all reporting groups
507892|NCT00754468|B2|Baseline|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.
CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
507893|NCT00754468|B1|Baseline|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.
CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
507894|NCT00754468|P2|Participant Flow|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.
CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
507895|NCT00754468|P1|Participant Flow|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.
CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
507896|NCT00754468|O2|Outcome|Group 2: Cryo Spray Ablation|Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds
507897|NCT00754468|O1|Outcome|Group 1: Cryo Spray Ablation|Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment
507898|NCT00754468|O2|Outcome|Group 2: Cryo Spray Ablation|"cryo spray ablation applied to healthy tissue 2 cycles x20 seconds
Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds"
507899|NCT00754468|O1|Outcome|Group 1: Cryo Spray Ablation|"cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds
Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment"
507922|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507923|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
508193|NCT00757666|B1|Baseline|Accelerometer|Accelerometer
507900|NCT00754468|E2|Reported Event|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.
CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
507901|NCT00754468|E1|Reported Event|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.
CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
507902|NCT00754494|B4|Baseline|Total|Total of all reporting groups
507903|NCT00754494|B3|Baseline|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
507904|NCT00754494|B2|Baseline|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
507905|NCT00754494|B1|Baseline|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
507906|NCT00754494|P3|Participant Flow|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
507907|NCT00754494|P2|Participant Flow|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
507908|NCT00754494|P1|Participant Flow|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
507909|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507910|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507911|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507912|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507913|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507914|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507915|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507916|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507917|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507918|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507919|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507920|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507921|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
508023|NCT00757588|B3|Baseline|Total|Total of all reporting groups
508194|NCT00757666|P2|Participant Flow|Minute Ventilation|Minute ventilation
507924|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507925|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507926|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507927|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507928|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507929|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507930|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507931|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507932|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507933|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507934|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507935|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507936|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507937|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507938|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507939|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507940|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507941|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507942|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507943|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507944|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507945|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 7 to 23 days"
507946|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 8 to 28 days"
507947|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies
The range of days on treatment is 10 to 29 days"
507948|NCT00754494|E3|Reported Event|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
508195|NCT00757666|P1|Participant Flow|Accelerometer|Accelerometer
507949|NCT00754494|E2|Reported Event|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
507950|NCT00754494|E1|Reported Event|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies"
507951|NCT00754546|B1|Baseline|All Participants|"All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:
Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline"
507952|NCT00754546|P1|Participant Flow|All Participants|"All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:
Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline"
507953|NCT00754546|O4|Outcome|Cycle Exercise With the Placebo Comparator|
507954|NCT00754546|O3|Outcome|Treadmill Exercise With the Placebo Comparator|
507955|NCT00754546|O2|Outcome|Cycle Exercise With the Active Comparator|
507956|NCT00754546|O1|Outcome|Treadmill Exercise With the Active Comparator|
507957|NCT00754546|O4|Outcome|Cycle Exercise With the Placebo Comparator|
507958|NCT00754546|O3|Outcome|Treadmill Exercise With the Placebo Comparator|
507959|NCT00754546|O2|Outcome|Cycle Exercise With the Active Comparator|
507960|NCT00754546|O1|Outcome|Treadmill Exercise With the Active Comparator|
507961|NCT00754546|E4|Reported Event|Cycle Exercise With the Placebo Comparator|
507962|NCT00754546|E3|Reported Event|Treadmill Exercise With the Placebo Comparator|
507963|NCT00754546|E2|Reported Event|Cycle Exercise With the Active Comparator|
507964|NCT00754546|E1|Reported Event|Treadmill Exercise With the Active Comparator|
507965|NCT00754559|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507966|NCT00754559|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks for a total of 6 infusions.
507967|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8mg /kg iv every 4 weeks for a total of 6 infusions.
507968|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507969|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507970|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
507971|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507972|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507973|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507974|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507975|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
507976|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
507977|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
507978|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507979|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
507980|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
507981|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
507982|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
507983|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507984|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507985|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507986|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507987|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507988|NCT00754559|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
507989|NCT00754572|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
507990|NCT00754572|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (iv), once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throuhgout the study.
507991|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
507992|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
507993|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508196|NCT00757666|O2|Outcome|Minute Ventilation|Minute ventilation
507994|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
507995|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
507996|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
507997|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
507998|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
507999|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508000|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508001|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508002|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508003|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508004|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508005|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508006|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508007|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508008|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508009|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508010|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508011|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508012|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508013|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508014|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508015|NCT00754572|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
508016|NCT00757484|B1|Baseline|Women Who Underwent Gyneologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
508017|NCT00757484|P1|Participant Flow|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
508018|NCT00757484|O1|Outcome|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
508019|NCT00757484|O1|Outcome|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
508020|NCT00757484|O1|Outcome|Women Who Underwent GYN Surgery|All women who underwent inpatient GYN surgery between Jan 2007 and 2008.
508021|NCT00757484|O1|Outcome|Women Who Underwent Scheduled Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008. Measure is categorized by the type of surgery.
508022|NCT00757484|E1|Reported Event|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient gynecologic surgery between Jan 2007 and 2008.
508027|NCT00757588|P1|Participant Flow|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508028|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508029|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508030|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508031|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508032|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508033|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508034|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508035|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508036|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508037|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508038|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508039|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508040|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508041|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508042|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508043|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508044|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508045|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508046|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508047|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508048|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508049|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508050|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508051|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508052|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508053|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508054|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508055|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508056|NCT00757588|E2|Reported Event|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
508057|NCT00757588|E1|Reported Event|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
508058|NCT00757601|B1|Baseline|All Participants|Participants were treated with MK1006 or dose-matched placebo over 5 treatment periods.
508059|NCT00757601|P12|Participant Flow|140mg MK1006/170mg MK1006/200mg MK1006/Placebo/260mg MK1006|Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
508060|NCT00757601|P11|Participant Flow|140mg MK1006/170mg MK1006/Placebo/230mg MK1006/260mg MK1006|Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
508061|NCT00757601|P10|Participant Flow|Placebo/170mg MK1006/200mg MK1006/230mg MK1006/260mg MK1006|Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
508096|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
508062|NCT00757601|P9|Participant Flow|140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo|Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5
508063|NCT00757601|P8|Participant Flow|60 mg MK1006/80 mg MK1006/100 mg MK1006/Placebo/140 mg MK1006|Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
508064|NCT00757601|P7|Participant Flow|60mg MK1006/80mg MK1006/Placebo/120mg MK1006/140mg MK1006|Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
508065|NCT00757601|P6|Participant Flow|Placebo/80mg MK1006/100mg MK1006/120mg MK1006/140mg MK1006|Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
508066|NCT00757601|P5|Participant Flow|60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo|Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
508067|NCT00757601|P4|Participant Flow|15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)|Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
508068|NCT00757601|P3|Participant Flow|15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)|Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
508069|NCT00757601|P2|Participant Flow|Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)|Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
508070|NCT00757601|P1|Participant Flow|15mg MK1006/Placebo/45mg MK1006/60mg MK1006/Placebo (Fed)|Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5.
508071|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
508072|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
508073|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
508074|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
508075|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
508076|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
508077|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
508078|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
508079|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
508080|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
508081|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
508082|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
508083|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
508084|NCT00757601|O14|Outcome|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
508085|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
508086|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
508087|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
508088|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
508089|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
508090|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
508091|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
508092|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
508093|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
508094|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
508095|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
508183|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
508097|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
508098|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
508099|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
508100|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
508101|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
508102|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
508103|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
508104|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
508105|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
508106|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
508107|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
508108|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
508109|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
508110|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
508111|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
508112|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
508113|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
508114|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
508115|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
508116|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
508117|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
508118|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
508119|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
508120|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
508121|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
508122|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
508123|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
508124|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
508125|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
508126|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
508127|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
508128|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
508129|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
508130|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
508131|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
508132|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
508133|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
508134|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
508135|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
508136|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
508137|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
508138|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
508139|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
508140|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
508141|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
508142|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
508143|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
508144|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
508145|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
508146|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
508147|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
508148|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
508149|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
508150|NCT00757601|O14|Outcome|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
508151|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
508152|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
508153|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
508154|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
508155|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
508156|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
508157|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
508158|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
508159|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
508160|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
508161|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
508162|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
508163|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
508164|NCT00757601|E14|Reported Event|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
508165|NCT00757601|E13|Reported Event|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
508166|NCT00757601|E12|Reported Event|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
508167|NCT00757601|E11|Reported Event|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
508168|NCT00757601|E10|Reported Event|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
508169|NCT00757601|E9|Reported Event|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
508170|NCT00757601|E8|Reported Event|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
508171|NCT00757601|E7|Reported Event|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
508172|NCT00757601|E6|Reported Event|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
508173|NCT00757601|E5|Reported Event|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
508174|NCT00757601|E4|Reported Event|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
508175|NCT00757601|E3|Reported Event|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
508176|NCT00757601|E2|Reported Event|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
508177|NCT00757601|E1|Reported Event|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
508178|NCT00757627|B1|Baseline|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
508179|NCT00757627|P1|Participant Flow|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
508180|NCT00757627|O1|Outcome|Etoricoxib 60 mg q.d.|
508181|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
508182|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
508202|NCT00757666|O2|Outcome|Minute Ventilation|"Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor.
Rate adaptive pacemaker: Minute ventilation sensor"
508203|NCT00757666|O1|Outcome|Accelerometer|"Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor.
Rate adaptive pacemaker: Accelerometer sensor"
508208|NCT00757705|B1|Baseline|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508209|NCT00757705|P1|Participant Flow|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508210|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508211|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508212|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508213|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508214|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508215|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508216|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508217|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508218|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508219|NCT00757705|E1|Reported Event|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
508220|NCT00757783|B3|Baseline|Total|Total of all reporting groups
508221|NCT00757783|B2|Baseline|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508222|NCT00757783|B1|Baseline|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508223|NCT00757783|P2|Participant Flow|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508224|NCT00757783|P1|Participant Flow|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508225|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508226|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508227|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508228|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508229|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508230|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508231|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508472|NCT00758459|E1|Reported Event|AZD1236|AZD1236
508232|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508233|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508234|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508235|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508236|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508237|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508238|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508239|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508240|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508241|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508242|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508243|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508244|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508245|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508246|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508247|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508248|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508249|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508250|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508251|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508252|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508253|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508254|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508255|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508256|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508257|NCT00757783|E2|Reported Event|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
508258|NCT00757783|E1|Reported Event|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
508259|NCT00757822|B3|Baseline|Total|Total of all reporting groups
508260|NCT00757822|B2|Baseline|Arm 2: Ondansetron|"ondansetron
Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
508261|NCT00757822|B1|Baseline|Arm 1: Dronabinol|"dronabinol
Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
508262|NCT00757822|P2|Participant Flow|Arm 2: Ondansetron|"ondansetron
Ondansetron: Ondansetron (4 mg) will be administered iv 20-30 min prior to end of surgery in those patients not receiving Dronabinol."
508263|NCT00757822|P1|Participant Flow|Arm 1: Dronabinol|"dronabinol
Dronabinol: Dronabinol (5mg) will be administered po 30-60 min prior start of surgery."
508264|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron
Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
508473|NCT00758485|B3|Baseline|Total|Total of all reporting groups
508265|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol
Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
508266|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron
Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
508267|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol
Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
508268|NCT00757822|O2|Outcome|Arm 2: Ondansetron|"ondansetron
Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
508270|NCT00757822|O2|Outcome|Arm 2: Ondnasetron|"ondansetron
Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
508271|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol
Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
508272|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron
Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
508273|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol
Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
508274|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron
Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
508275|NCT00757822|O1|Outcome|Arm 1: Dronabinol|"dronabinol
Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
508276|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron
Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
508277|NCT00757822|O1|Outcome|Arm 1: Dronabinol|"dronabinol
Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
508278|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron
Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
508279|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol
Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
508280|NCT00757822|E2|Reported Event|Ondansetron-control Therapy|Ondansetron (4 mg) was administered iv 20-30 min prior to end of elective abdominal surgery scheduled for same day discharge to home.
508281|NCT00757822|E1|Reported Event|Dronabinol- Experimental Therapy|Dronabinol (5mg) was administered po 30-60 min prior to start of elective abdominal surgery scheduled for same day discharge to home.
508282|NCT00757848|B3|Baseline|Total|Total of all reporting groups
508283|NCT00757848|B2|Baseline|Placebo|Placebo, 2 tablets twice daily (bid)
508284|NCT00757848|B1|Baseline|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508285|NCT00757848|P2|Participant Flow|Placebo|Placebo, 2 tablets twice daily (bid)
508286|NCT00757848|P1|Participant Flow|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508287|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508288|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508289|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508290|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508291|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508292|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508293|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508294|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508295|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508296|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508297|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508298|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508299|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508300|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508301|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508302|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508303|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508304|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508305|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508306|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508307|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508308|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508309|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508310|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508311|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508312|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508313|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508314|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508315|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508316|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508317|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508318|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508319|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508320|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508321|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508322|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508323|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508324|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508325|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
508326|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508327|NCT00757848|E2|Reported Event|Placebo|Placebo, 2 tablets twice daily (bid)
508328|NCT00757848|E1|Reported Event|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
508329|NCT00758043|B5|Baseline|Total|Total of all reporting groups
508330|NCT00758043|B4|Baseline|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
508331|NCT00758043|B3|Baseline|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
508332|NCT00758043|B2|Baseline|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
508577|NCT00758550|P2|Participant Flow|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
508333|NCT00758043|B1|Baseline|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
508334|NCT00758043|P4|Participant Flow|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
508335|NCT00758043|P3|Participant Flow|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
508336|NCT00758043|P2|Participant Flow|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
508337|NCT00758043|P1|Participant Flow|T12PR24 (eRVR+)|Telaprevir + peginterferon-alfa-2a (Peg-IFN-alfa-2a) + ribavirin (RBV) for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
508338|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
508339|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
508340|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
508341|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
508342|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
508343|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
508344|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
508345|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
508346|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
508347|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
508348|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
508349|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
508350|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
508351|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
508352|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
508353|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
508354|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
508355|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
508356|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
508357|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
508358|NCT00758043|E4|Reported Event|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
508359|NCT00758043|E3|Reported Event|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
508474|NCT00758485|B2|Baseline|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
508360|NCT00758043|E2|Reported Event|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
508361|NCT00758043|E1|Reported Event|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
508362|NCT00758069|B4|Baseline|Total|Total of all reporting groups
508363|NCT00758069|B3|Baseline|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
508364|NCT00758069|B2|Baseline|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
508365|NCT00758069|B1|Baseline|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
508366|NCT00758069|P3|Participant Flow|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
508367|NCT00758069|P2|Participant Flow|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
508368|NCT00758069|P1|Participant Flow|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
508369|NCT00758069|O3|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
508370|NCT00758069|O2|Outcome|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
508371|NCT00758069|O1|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
508372|NCT00758069|O3|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
508373|NCT00758069|O2|Outcome|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
508374|NCT00758069|O1|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
508375|NCT00758069|E3|Reported Event|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
508376|NCT00758069|E2|Reported Event|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
508377|NCT00758069|E1|Reported Event|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
508378|NCT00758160|B1|Baseline|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508379|NCT00758160|P1|Participant Flow|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508380|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508381|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508382|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508383|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508384|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508385|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508386|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508387|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508388|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508389|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508390|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508391|NCT00758160|O1|Outcome|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508392|NCT00758160|E4|Reported Event|OROS MPH-Week 8|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508475|NCT00758485|B1|Baseline|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
508807|NCT00758758|B6|Baseline|Allograft With Plate|Allograft with plate
508393|NCT00758160|E3|Reported Event|OROS MPH-Week 4|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508394|NCT00758160|E2|Reported Event|OROS MPH-Week 2|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508578|NCT00758550|P1|Participant Flow|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
508395|NCT00758160|E1|Reported Event|OROS MPH-Baseline|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
508396|NCT00758290|B3|Baseline|Total|Total of all reporting groups
508397|NCT00758290|B2|Baseline|Triclosan/Fluoride|
508398|NCT00758290|B1|Baseline|Fluoride/Triclosan|
508399|NCT00758290|P2|Participant Flow|Triclosan/Fluoride|
508400|NCT00758290|P1|Participant Flow|Fluoride/Triclosan|
508401|NCT00758290|O2|Outcome|Triclosan/Fluoride|
508402|NCT00758290|O1|Outcome|Fluoride/Triclosan|
508403|NCT00758342|B3|Baseline|Total|Total of all reporting groups
508404|NCT00758342|B2|Baseline|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
508405|NCT00758342|B1|Baseline|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
508406|NCT00758342|P2|Participant Flow|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
508407|NCT00758342|P1|Participant Flow|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
508408|NCT00758342|O2|Outcome|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
508409|NCT00758342|O1|Outcome|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
508410|NCT00758342|E2|Reported Event|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
508411|NCT00758342|E1|Reported Event|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
508412|NCT00758394|B5|Baseline|Total|Total of all reporting groups
508413|NCT00758394|B4|Baseline|Triclosan/Fluoride/Cavistat|toothpaste containing bicarbonate
508414|NCT00758394|B3|Baseline|Triclosan/Fluoride/Arginine|toothpaste containing amino acid
508415|NCT00758394|B2|Baseline|Fluoride/Triclosan - B|Positive control comparator
508416|NCT00758394|B1|Baseline|Fluoride - A|Negative control
508417|NCT00758394|P4|Participant Flow|Triclosan/Fluoride/Cavistat First|Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
508418|NCT00758394|P3|Participant Flow|Triclosan/Fluoride/Arginine First|Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
508419|NCT00758394|P2|Participant Flow|Triclosan/Fluoride First|Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
508420|NCT00758394|P1|Participant Flow|Fluoride First|Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
508421|NCT00758394|O4|Outcome|Triclosan/Fluoride/Cavistat|toothpaste containing bicarbonate
508422|NCT00758394|O3|Outcome|Triclosan/Fluoride/Arginine|toothpaste containing amino acid
508423|NCT00758394|O2|Outcome|Fluoride/Triclosan - B|Positive control comparator
508424|NCT00758394|O1|Outcome|Fluoride - A|Negative control
508425|NCT00758394|E4|Reported Event|Triclosan/Fluoride/Cavistat First|Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
508426|NCT00758394|E3|Reported Event|Triclosan/Fluoride/Arginine First|Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
508427|NCT00758394|E2|Reported Event|Triclosan/Fluoride First|Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
508428|NCT00758394|E1|Reported Event|Fluoride First|Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
508429|NCT00758420|B3|Baseline|Total|Total of all reporting groups
508430|NCT00758420|B2|Baseline|Polidocanol Injectable Foam, 1.0%|Polidocanol injectable foam 1%, up to 15 mL, one treatment session
508431|NCT00758420|B1|Baseline|Placebo|Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
508432|NCT00758420|P2|Participant Flow|Placebo|"Agitated saline
Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session"
508433|NCT00758420|P1|Participant Flow|Active Treatment|polidocanol injectiable foam 1%, up to 15 mL, one treatment session
508434|NCT00758420|O2|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam 1%, up to 15 mL, one treatment session
508435|NCT00758420|O1|Outcome|Placebo|agitated saline
508436|NCT00758420|E2|Reported Event|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam 1%, up to 15 mL, one treatment session
508437|NCT00758420|E1|Reported Event|Placebo|agitated saline
508438|NCT00758459|B3|Baseline|Total|Total of all reporting groups
508439|NCT00758459|B2|Baseline|Placebo|Placebo
508440|NCT00758459|B1|Baseline|AZD1236|AZD1236
508441|NCT00758459|P2|Participant Flow|Placebo|Placebo
508442|NCT00758459|P1|Participant Flow|AZD1236|AZD1236
508443|NCT00758459|O2|Outcome|Placebo|Placebo
508444|NCT00758459|O1|Outcome|AZD1236|AZD1236
508445|NCT00758459|O2|Outcome|Placebo|Placebo
508446|NCT00758459|O1|Outcome|AZD1236|AZD1236
508447|NCT00758459|O2|Outcome|Placebo|Placebo
508448|NCT00758459|O1|Outcome|AZD1236|AZD1236
508449|NCT00758459|O2|Outcome|Placebo|Placebo
508450|NCT00758459|O1|Outcome|AZD1236|AZD1236
508451|NCT00758459|O2|Outcome|Placebo|Placebo
508452|NCT00758459|O1|Outcome|AZD1236|AZD1236
508453|NCT00758459|O2|Outcome|Placebo|Placebo
508454|NCT00758459|O1|Outcome|AZD1236|AZD1236
508455|NCT00758459|O2|Outcome|Placebo|Placebo
508456|NCT00758459|O1|Outcome|AZD1236|AZD1236
508457|NCT00758459|O2|Outcome|Placebo|Placebo
508458|NCT00758459|O1|Outcome|AZD1236|AZD1236
508476|NCT00758485|P2|Participant Flow|Placebo|Participants receiving Placebo (0.9% sodium chloride[NaCl]) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
508477|NCT00758485|P1|Participant Flow|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium
508478|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
508479|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
508480|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
508481|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
508482|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
508483|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg/kg-1 Sugammadex at a target depth of NMB of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium
508484|NCT00758485|E2|Reported Event|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
508485|NCT00758485|E1|Reported Event|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
508486|NCT00758498|B4|Baseline|Total|Total of all reporting groups
508487|NCT00758498|B3|Baseline|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508488|NCT00758498|B2|Baseline|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508489|NCT00758498|B1|Baseline|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508490|NCT00758498|P3|Participant Flow|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508491|NCT00758498|P2|Participant Flow|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508492|NCT00758498|P1|Participant Flow|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508493|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508494|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508495|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508496|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508497|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508498|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508499|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508500|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508501|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508502|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508503|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508504|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508505|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508506|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508507|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508508|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508509|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508640|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508808|NCT00758758|B5|Baseline|Autograft With Plate|Autograft with plate
508510|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508511|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508579|NCT00758550|O2|Outcome|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
508512|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508513|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508514|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508515|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508516|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508517|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508518|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508519|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508520|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508521|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508522|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508523|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508524|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508525|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508526|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508527|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508528|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508529|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508530|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508531|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508532|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508533|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508534|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508535|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508536|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508537|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508538|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508539|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508540|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508541|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508542|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508543|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508544|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508545|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508546|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508547|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508548|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508549|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508550|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508551|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508552|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508553|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508554|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508555|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508556|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508557|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508558|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508559|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508560|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508561|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508562|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508563|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508564|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508565|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508566|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508567|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508568|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508569|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508570|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508571|NCT00758498|E3|Reported Event|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508572|NCT00758498|E2|Reported Event|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508641|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
509077|NCT00759564|B6|Baseline|Total|Total of all reporting groups
508573|NCT00758498|E1|Reported Event|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
508574|NCT00758550|B3|Baseline|Total|Total of all reporting groups
508575|NCT00758550|B2|Baseline|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
508580|NCT00758550|O1|Outcome|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
508581|NCT00758550|O2|Outcome|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
508582|NCT00758550|O1|Outcome|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
508583|NCT00758550|E2|Reported Event|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
508584|NCT00758550|E1|Reported Event|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
508585|NCT00758563|B3|Baseline|Total|Total of all reporting groups
508586|NCT00758563|B2|Baseline|Triclosan|
508587|NCT00758563|B1|Baseline|Fluoride|
508588|NCT00758563|P2|Participant Flow|Triclosan|
508589|NCT00758563|P1|Participant Flow|Fluoride|
508590|NCT00758563|O2|Outcome|Triclosan|
508591|NCT00758563|O1|Outcome|Fluoride|
508592|NCT00758576|B1|Baseline|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
508593|NCT00758576|P1|Participant Flow|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
508594|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
508595|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
508596|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
508597|NCT00758576|E1|Reported Event|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
508598|NCT00758589|B5|Baseline|Total|Total of all reporting groups
508599|NCT00758589|B4|Baseline|Placebo|placebo oral tablet, twice daily
508600|NCT00758589|B3|Baseline|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508601|NCT00758589|B2|Baseline|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508602|NCT00758589|B1|Baseline|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508603|NCT00758589|P4|Participant Flow|Placebo|placebo oral tablet, twice daily
508604|NCT00758589|P3|Participant Flow|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508605|NCT00758589|P2|Participant Flow|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508606|NCT00758589|P1|Participant Flow|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508607|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508608|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508609|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508610|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508611|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508612|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508613|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508614|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508615|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508616|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508617|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508618|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508619|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508620|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508621|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508622|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508623|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508624|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508625|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508626|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508627|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508628|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508629|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508630|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508631|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508632|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508633|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508634|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508635|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508636|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508637|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508638|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508639|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508642|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508643|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508644|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508645|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508646|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508647|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508648|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508649|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508650|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508651|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508652|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508653|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508654|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508655|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508656|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508657|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508658|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508659|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508660|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508661|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508662|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508663|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
508664|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508665|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508666|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508667|NCT00758589|E4|Reported Event|Placebo|placebo oral tablet, twice daily
508668|NCT00758589|E3|Reported Event|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
508669|NCT00758589|E2|Reported Event|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
508670|NCT00758589|E1|Reported Event|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
508671|NCT00758602|B3|Baseline|Total|Total of all reporting groups
508672|NCT00758602|B2|Baseline|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508673|NCT00758602|B1|Baseline|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508674|NCT00758602|P2|Participant Flow|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508675|NCT00758602|P1|Participant Flow|Mycophenolate Mofetil (MMF), Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 gram (g) orally (PO), twice daily (BID) from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508676|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508677|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508678|NCT00758602|O2|Outcome|MMFl, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508679|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508812|NCT00758758|B1|Baseline|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
508813|NCT00758758|P8|Participant Flow|Autograft 2 Levels With Plate|Autograft 2 levels with plate
508814|NCT00758758|P7|Participant Flow|Allograft 2 Levels With Plate|Allograft 2 levels with plate
508680|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508681|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508682|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508683|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508684|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508685|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508686|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508687|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508688|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508689|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508690|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508691|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508804|NCT00758758|B9|Baseline|Total|Total of all reporting groups
508805|NCT00758758|B8|Baseline|Allograft 2 Levels With Plate|Allograft 2 levels with plate
508806|NCT00758758|B7|Baseline|Autograft 2 Levels With Plate|Autograft 2 levels with plate
508719|NCT00758680|O9|Outcome|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
508815|NCT00758758|P6|Participant Flow|Allograft 1 Level With Plate|Allograft 1 level plated
508692|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508693|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508694|NCT00758602|E2|Reported Event|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508695|NCT00758602|E1|Reported Event|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
508696|NCT00758667|B3|Baseline|Total|Total of all reporting groups
508697|NCT00758667|B2|Baseline|Mesna|"The use of Mesna of removal of capsule for capsular contracture.
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
508698|NCT00758667|B1|Baseline|Standard|"Standard procedure or capsulectomy for removal of capsule; no mesna
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
508699|NCT00758667|P2|Participant Flow|Mesna|"The use of Mesna of removal of capsule for capsular contracture.
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
508700|NCT00758667|P1|Participant Flow|Standard|Standard procedure or capsulectomy for removal of capsule;
508701|NCT00758667|O2|Outcome|Mesna|"The use of Mesna of removal of capsule for capsular contracture.
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
508702|NCT00758667|O1|Outcome|Standard|Standard procedure or capsulectomy for removal of capsule;
508703|NCT00758667|O2|Outcome|Mesna|"The use of Mesna of removal of capsule for capsular contracture.
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
508704|NCT00758667|O1|Outcome|Standard|"Standard procedure or capsulectomy for removal of capsule; no mesna
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
508705|NCT00758667|E2|Reported Event|Mesna|"The use of Mesna of removal of capsule for capsular contracture.
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
508706|NCT00758667|E1|Reported Event|Standard|Standard procedure or capsulectomy for removal of capsule;
508707|NCT00758680|B1|Baseline|All Treated Participants|After a 2-week run-in/wash-off period, participants received doses of MK-1006 or matching placebo over a multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
508708|NCT00758680|P10|Participant Flow|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
508709|NCT00758680|P9|Participant Flow|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
508710|NCT00758680|P8|Participant Flow|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
508711|NCT00758680|P7|Participant Flow|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508712|NCT00758680|P6|Participant Flow|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508713|NCT00758680|P5|Participant Flow|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508714|NCT00758680|P4|Participant Flow|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508715|NCT00758680|P3|Participant Flow|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508716|NCT00758680|P2|Participant Flow|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508717|NCT00758680|P1|Participant Flow|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
508718|NCT00758680|O10|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
508720|NCT00758680|O8|Outcome|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
508721|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508722|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508723|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508724|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508725|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508726|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508727|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
508728|NCT00758680|O8|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
508729|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508730|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508731|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508732|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508733|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508734|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508735|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
508736|NCT00758680|O10|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
508737|NCT00758680|O9|Outcome|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
508738|NCT00758680|O8|Outcome|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
508739|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508740|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508741|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508742|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508743|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508744|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508745|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
508746|NCT00758680|E10|Reported Event|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
508747|NCT00758680|E9|Reported Event|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
508748|NCT00758680|E8|Reported Event|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
508749|NCT00758680|E7|Reported Event|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508750|NCT00758680|E6|Reported Event|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508751|NCT00758680|E5|Reported Event|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508752|NCT00758680|E4|Reported Event|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508753|NCT00758680|E3|Reported Event|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508754|NCT00758680|E2|Reported Event|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
508755|NCT00758680|E1|Reported Event|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
508756|NCT00758706|B3|Baseline|Total|Total of all reporting groups
508757|NCT00758706|B2|Baseline|Placebo|Placebo to AZD1236 twice daily(bid)
508758|NCT00758706|B1|Baseline|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508759|NCT00758706|P2|Participant Flow|Placebo|Placebo to AZD1236 twice daily(bid)
508760|NCT00758706|P1|Participant Flow|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508761|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508762|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508763|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508764|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508765|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508766|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508767|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508768|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508769|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508770|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508771|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508772|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508773|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508774|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508775|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508776|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508777|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508778|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508779|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508780|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508781|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508782|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508783|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508784|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508785|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508786|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508787|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508788|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508789|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508790|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508791|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
508792|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508793|NCT00758706|E2|Reported Event|Placebo|Placebo to AZD1236 twice daily(bid)
508794|NCT00758706|E1|Reported Event|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
508795|NCT00758745|B3|Baseline|Total|Total of all reporting groups
508796|NCT00758745|B2|Baseline|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
508797|NCT00758745|B1|Baseline|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
508798|NCT00758745|P2|Participant Flow|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
508799|NCT00758745|P1|Participant Flow|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
508800|NCT00758745|O2|Outcome|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
508801|NCT00758745|O1|Outcome|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
508802|NCT00758745|E2|Reported Event|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
508803|NCT00758745|E1|Reported Event|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
508809|NCT00758758|B4|Baseline|Autograft Only - Illiac Crest|Autograft only - Illiac crest
508810|NCT00758758|B3|Baseline|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
508811|NCT00758758|B2|Baseline|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
508816|NCT00758758|P5|Participant Flow|Autograft 1 Level With Plate|Autograft 1 level plated
508817|NCT00758758|P4|Participant Flow|Autograft Only - Illiac Crest|Autograft only - illiac crest
508818|NCT00758758|P3|Participant Flow|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
508819|NCT00758758|P2|Participant Flow|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
508820|NCT00758758|P1|Participant Flow|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
508821|NCT00758758|O8|Outcome|Allograft With 2 Plates|2 Levels with plated Allograft
508822|NCT00758758|O7|Outcome|Autograft With 2 Plates|2 Levels with plated Autograft
508823|NCT00758758|O6|Outcome|Allograft With Plate|Plated Allograft
508824|NCT00758758|O5|Outcome|Autograft With Plate|Plated Autograft
508825|NCT00758758|O4|Outcome|Illiac Crest Autograft|Iliac Crest Autograft
508826|NCT00758758|O3|Outcome|2 Levels Hedrocel With Plate|2 Levels Plated Hedrocel
508827|NCT00758758|O2|Outcome|Hedrocel With Plate|Hedrocel with a plate
508828|NCT00758758|O1|Outcome|1 Level Hedrocel Without Plate|1 level Hedrocel without plate
508829|NCT00758758|O8|Outcome|2 Levels With Plated Allograft|2 Levels with plated Allograft
508830|NCT00758758|O7|Outcome|2 Levels Plated Autograft|2 Levels with plated Autograft
508831|NCT00758758|O6|Outcome|Plated Allograft|Plated Allograft
508832|NCT00758758|O5|Outcome|Plated Autograft|Plated Autograft
508833|NCT00758758|O4|Outcome|Illiac Crest Autograft - no Plate|Iliac Crest Autograft
508834|NCT00758758|O3|Outcome|Two Levels Plated Hedrocel|2 Levels Plated Hedrocel
508835|NCT00758758|O2|Outcome|One Level Hedrocel With Plate|Hedrocel with a plate
508836|NCT00758758|O1|Outcome|1 Level Hedrocel Without Plate|1 level Hedrocel with out plate
508837|NCT00758758|E8|Reported Event|Allograft 2 Levels With Plate|Allograft 2 levels with plate
508838|NCT00758758|E7|Reported Event|Autograft 2 Levels With Plate|Autograft 2 levels with plate
508839|NCT00758758|E6|Reported Event|Allograft With Plate|Allograft with plate
508840|NCT00758758|E5|Reported Event|Autograft With Plate|Autograft with plate
508841|NCT00758758|E4|Reported Event|Autograft Only - Illiac Crest|Autograft only - Illiac crest
508842|NCT00758758|E3|Reported Event|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
508843|NCT00758758|E2|Reported Event|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
508844|NCT00758758|E1|Reported Event|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
508845|NCT00758771|B3|Baseline|Total|Total of all reporting groups
508846|NCT00758771|B2|Baseline|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
508847|NCT00758771|B1|Baseline|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
508848|NCT00758771|P2|Participant Flow|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
508849|NCT00758771|P1|Participant Flow|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
508850|NCT00758771|O2|Outcome|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
508851|NCT00758771|O1|Outcome|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
508852|NCT00758771|E2|Reported Event|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
508853|NCT00758771|E1|Reported Event|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
508854|NCT00758836|B5|Baseline|Total|Total of all reporting groups
508855|NCT00758836|B4|Baseline|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
508856|NCT00758836|B3|Baseline|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
508857|NCT00758836|B2|Baseline|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
508858|NCT00758836|B1|Baseline|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
508859|NCT00758836|P4|Participant Flow|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
508860|NCT00758836|P3|Participant Flow|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
508861|NCT00758836|P2|Participant Flow|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
508862|NCT00758836|P1|Participant Flow|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
508863|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
508864|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
508865|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
508866|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
509585|NCT00762021|B3|Baseline|Total|Total of all reporting groups
508867|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
508868|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
508869|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
508870|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
508871|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
508872|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
508873|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
508874|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
508875|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
508876|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
508877|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
508878|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
508879|NCT00758836|E4|Reported Event|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
508880|NCT00758836|E3|Reported Event|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
508881|NCT00758836|E2|Reported Event|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
508882|NCT00758836|E1|Reported Event|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
508883|NCT00759031|B3|Baseline|Total|Total of all reporting groups
508884|NCT00759031|B2|Baseline|Triclosan + Fluoride 1st, Then Fluoride 2nd|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
508885|NCT00759031|B1|Baseline|Fluoride 1st, Then Triclosan +Fluoride 2nd|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
508886|NCT00759031|P2|Participant Flow|Triclosan + Fluoride 1st, Fluoride 2nd|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
508887|NCT00759031|P1|Participant Flow|Fluoride 1st, Triclosan +Fluoride 2nd|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
508888|NCT00759031|O2|Outcome|Triclosan + Fluoride|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
508889|NCT00759031|O1|Outcome|Fluoride|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
508890|NCT00759031|E2|Reported Event|Triclosan + Fluoride|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
508891|NCT00759031|E1|Reported Event|Fluoride|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
508892|NCT00759096|B1|Baseline|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
508893|NCT00759096|P1|Participant Flow|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
508894|NCT00759096|O1|Outcome|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
508895|NCT00759096|E1|Reported Event|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
508896|NCT00759109|B3|Baseline|Total|Total of all reporting groups
508897|NCT00759109|B2|Baseline|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
508898|NCT00759109|B1|Baseline|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
508899|NCT00759109|P2|Participant Flow|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
508900|NCT00759109|P1|Participant Flow|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
508901|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
508902|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
508903|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
508904|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
508905|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
508906|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
508907|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
508908|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
511088|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
508909|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
508910|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
508911|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
508912|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
509297|NCT00759759|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
508913|NCT00759109|E2|Reported Event|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
508914|NCT00759109|E1|Reported Event|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
508915|NCT00759148|B3|Baseline|Total|Total of all reporting groups
508916|NCT00759148|B2|Baseline|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
508917|NCT00759148|B1|Baseline|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
508918|NCT00759148|P2|Participant Flow|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
508919|NCT00759148|P1|Participant Flow|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
508920|NCT00759148|O2|Outcome|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
508921|NCT00759148|O1|Outcome|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
508922|NCT00759148|O2|Outcome|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
508923|NCT00759148|O1|Outcome|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
508924|NCT00759148|E2|Reported Event|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
508925|NCT00759148|E1|Reported Event|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
508926|NCT00759161|B1|Baseline|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508927|NCT00759161|P1|Participant Flow|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508928|NCT00759161|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508929|NCT00759161|O2|Outcome|Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508930|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508931|NCT00759161|O2|Outcome|Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508932|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508933|NCT00759161|O2|Outcome|Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508934|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508935|NCT00759161|O2|Outcome|AN2728 Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508936|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508937|NCT00759161|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508938|NCT00759161|E1|Reported Event|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
508939|NCT00759174|B3|Baseline|Total|Total of all reporting groups
508940|NCT00759174|B2|Baseline|Potential NAION Cases Without PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
508941|NCT00759174|B1|Baseline|Potential NAION Cases With PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
508942|NCT00759174|P2|Participant Flow|Potential NAION Cases Without PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
508943|NCT00759174|P1|Participant Flow|Potential NAION Cases With PDE5i Exposure|Participants who met pre-defined potential acute nonarteritic anterior ischemic optic neuropathy (NAION) criteria and were exposed to phosphodiesterase type 5 inhibitors (PDE5i) (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
511628|NCT00756938|E5|Reported Event|Extension-Losartan 0.1 mg/kg/Day|
508944|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 7 weeks preceding the case window.
508980|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
508945|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the week preceding the symptom onset day.
508946|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
508947|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.
508948|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
508949|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.
508950|NCT00759174|E1|Reported Event|Potential NAION Cases|All participants who met pre-defined potential acute NAION criteria and were either exposed or not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
508951|NCT00759187|B4|Baseline|Total|Total of all reporting groups
508952|NCT00759187|B3|Baseline|Chlorhexidine Gluconate|
508953|NCT00759187|B2|Baseline|Fluoride/Triclosan|
508954|NCT00759187|B1|Baseline|Fluoride|
508955|NCT00759187|P3|Participant Flow|Chlorhexidine Gluconate|
508956|NCT00759187|P2|Participant Flow|Fluoride/Triclosan|
508957|NCT00759187|P1|Participant Flow|Fluoride|
508958|NCT00759187|O3|Outcome|Chlorhexidine Gluconate|
508959|NCT00759187|O2|Outcome|Fluoride/Triclosan|
508960|NCT00759187|O1|Outcome|Fluoride|
508961|NCT00759187|E3|Reported Event|Chlorhexidine Gluconate|
508962|NCT00759187|E2|Reported Event|Fluoride/Triclosan|
508963|NCT00759187|E1|Reported Event|Fluoride|
508964|NCT00759330|B5|Baseline|Total|Total of all reporting groups
508965|NCT00759330|B4|Baseline|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508966|NCT00759330|B3|Baseline|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
508967|NCT00759330|B2|Baseline|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508968|NCT00759330|B1|Baseline|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
508969|NCT00759330|P4|Participant Flow|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508970|NCT00759330|P3|Participant Flow|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
508971|NCT00759330|P2|Participant Flow|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508972|NCT00759330|P1|Participant Flow|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
508973|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508974|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
508975|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508976|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
508977|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508978|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
508979|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508981|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508982|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
508983|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508984|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
508985|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508986|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
508987|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508988|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
508989|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508990|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
508991|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508992|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
508993|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508994|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
508995|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508996|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
508997|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
508998|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
508999|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
509000|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
509001|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
509002|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
509003|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
509004|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
509005|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
509006|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
509007|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
509008|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
509009|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
509010|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
509011|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
509012|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
509013|NCT00759330|E4|Reported Event|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
509014|NCT00759330|E3|Reported Event|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
509015|NCT00759330|E2|Reported Event|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
509016|NCT00759330|E1|Reported Event|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
509017|NCT00759356|B3|Baseline|Total|Total of all reporting groups
509018|NCT00759356|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
509019|NCT00759356|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
509020|NCT00759356|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
509021|NCT00759356|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
509022|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
509023|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
509024|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
509025|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
509026|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
509027|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
509028|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
509029|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
509030|NCT00759356|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
509031|NCT00759356|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
509032|NCT00759395|B3|Baseline|Total|Total of all reporting groups
509033|NCT00759395|B2|Baseline|Placebo|Placebo BID, Tablet, Oral, Daily
509034|NCT00759395|B1|Baseline|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
509035|NCT00759395|P2|Participant Flow|Placebo|Placebo BID, Tablet, Oral, Daily
509036|NCT00759395|P1|Participant Flow|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
509037|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
509038|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
509039|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
509040|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
509041|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
509042|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
509043|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
509044|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
509045|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
509046|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
509047|NCT00759395|E2|Reported Event|Placebo|Placebo BID, Tablet, Oral, Daily
509048|NCT00759395|E1|Reported Event|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
509049|NCT00759473|B6|Baseline|Total|Total of all reporting groups
509050|NCT00759473|B5|Baseline|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue expsosure sessions, and at the one-week follow-up session. Participants also received cognitive skills training.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
509098|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509051|NCT00759473|B4|Baseline|DCS /DCS/Placebo|Participants were assigned to receive 50 mg of DCS at 2 cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
509298|NCT00759772|B3|Baseline|Total|Total of all reporting groups
509052|NCT00759473|B3|Baseline|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of DCS at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
509053|NCT00759473|B2|Baseline|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
509054|NCT00759473|B1|Baseline|DCS/DCS/DCS/Placebo|Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
509055|NCT00759473|P5|Participant Flow|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue exposure sessions, and at the one-week follow-up session. Participants also received cognitive skills training. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
509056|NCT00759473|P4|Participant Flow|DCS/DCS/Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) at 2 cue cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
509057|NCT00759473|P3|Participant Flow|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
509058|NCT00759473|P2|Participant Flow|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
509059|NCT00759473|P1|Participant Flow|DCS/DCS/DCS/ Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) for each of 3 cue exposure sessions and a placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
509060|NCT00759473|O5|Outcome|Placebo Plus Cognitive Skills Training|Participants received a placebo at 2 cue extinction sessions and at the one-week follow-up session. Participants also received cognitive skills training.
509061|NCT00759473|O4|Outcome|DCS Plus Cognitive Skills Training|Participants received 50 mg of DCS at 2 cue extinction sessions and placebo at the one-week follow-up session. Participants also received cognitive skills training.
509062|NCT00759473|O3|Outcome|DCS/ Placebo/DCS|Participants received 50 mg of DCS at the 1st and 3rd cue exposure sessions, and placebo at the 2nd cue exposure session and the one-week follow-up session.
509063|NCT00759473|O2|Outcome|Placebo Only|Participants received a placebo at each of 3 cue exposure sessions and at the one-week follow-up session.
509064|NCT00759473|O1|Outcome|DCS Only|Participants received 50 mg of DCS at each of 3 cue exposure sessions and placebo at the one-week follow-up session.
509065|NCT00759473|E5|Reported Event|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue exposure sessions, and at the one-week follow-up session.
509066|NCT00759473|E4|Reported Event|DCS /DCS/Placebo|Participants were assigned to receive 50 mg of DCS at 2 cue exposure sessions, and placebo at the one-week follow-up session.
509067|NCT00759473|E3|Reported Event|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of DCS at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session.
509068|NCT00759473|E2|Reported Event|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.
509069|NCT00759473|E1|Reported Event|DCS/DCS/DCS/Placebo|Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.
509070|NCT00759525|B1|Baseline|All Study Participants|
509071|NCT00759525|P2|Participant Flow|Placebo First, Then Glycyrrhetinic Acid|Placebo followed by Glycyrrhetic Acid-130 mg/day for 14 days
509072|NCT00759525|P1|Participant Flow|Glycyrrhetinic Acid First, Then Placebo|Glycyrrhetic Acid-130 mg/day for 14 days followed by placebo
509073|NCT00759525|O2|Outcome|Placebo|All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.
509074|NCT00759525|O1|Outcome|Glycyrrhinitic Acid|All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.
509075|NCT00759525|E2|Reported Event|Placebo First, Then Glycyrrhetinic Acid|Healthy subjects without medical condition.
509076|NCT00759525|E1|Reported Event|Glycyrrhetinic Acid First, Then Placebo|Healthy subjects without medical condition.
509078|NCT00759564|B5|Baseline|CP-70,429 (200 mg) + PF-03709270: Severe Renal Function|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-­70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF­-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
509396|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
509079|NCT00759564|B4|Baseline|CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
509080|NCT00759564|B3|Baseline|CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP­-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
509081|NCT00759564|B2|Baseline|CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
509082|NCT00759564|B1|Baseline|CP-70,429 (800 mg) + PF-03709270: Normal Renal Impairment|Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
509083|NCT00759564|P5|Participant Flow|CP-70,429 (200 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-­70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF­-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
509084|NCT00759564|P4|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
509085|NCT00759564|P3|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP­-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
509086|NCT00759564|P2|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
509087|NCT00759564|P1|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Normal Renal Function|Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
509088|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509089|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509090|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509091|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509092|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509093|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
509094|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509095|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509096|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509097|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509289|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
509099|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509241|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
509100|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509101|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509102|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
509103|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509104|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509105|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509106|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509107|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509108|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509109|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509110|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509111|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
509112|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509113|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509114|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509115|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509116|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509117|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509118|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509119|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509120|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
509121|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509122|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509123|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509124|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509125|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509126|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509127|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509128|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509129|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
509130|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509131|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509132|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509133|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509134|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509135|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509136|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509137|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509138|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509139|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509140|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509141|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509142|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509143|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509144|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509145|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
509146|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
509147|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509148|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509149|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509150|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509151|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509152|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509153|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
509154|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
509290|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
509291|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
509155|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509156|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509157|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509158|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509159|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509160|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509161|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509162|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509163|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509164|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509165|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509166|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509167|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509168|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509169|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
509170|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
509171|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509172|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509173|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509174|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509175|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509176|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509177|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
509178|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
509179|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509180|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509181|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509182|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
509183|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509184|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
509185|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509186|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
509187|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF­03709270 1000 mg tablet in second intervention period.
509188|NCT00759564|O1|Outcome|PF­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
509189|NCT00759564|O4|Outcome|PF­-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
509190|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
509191|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509192|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
509193|NCT00759564|O4|Outcome|PF-­03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
509194|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
509195|NCT00759564|O2|Outcome|PF-­03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
509196|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
509197|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509198|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509199|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509200|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509201|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509202|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509203|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509204|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509205|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509206|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509207|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509208|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509209|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509210|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509242|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
509211|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509212|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509213|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509214|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509215|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509216|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509217|NCT00759564|E9|Reported Event|PF-03709270 (1000 mg): Severe Renal|Participants with severe renal impairment received a single oral dose of PF-03709270 1000 mg tablet under fasted condition in second intervention period.
509218|NCT00759564|E8|Reported Event|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509219|NCT00759564|E7|Reported Event|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509220|NCT00759564|E6|Reported Event|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
509221|NCT00759564|E5|Reported Event|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509222|NCT00759564|E4|Reported Event|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
509223|NCT00759564|E3|Reported Event|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509224|NCT00759564|E2|Reported Event|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509225|NCT00759564|E1|Reported Event|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
509226|NCT00759577|B1|Baseline|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
509227|NCT00759577|P1|Participant Flow|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
509228|NCT00759577|O1|Outcome|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
509229|NCT00759577|E1|Reported Event|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
509230|NCT00759603|B1|Baseline|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
509231|NCT00759603|P1|Participant Flow|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
509232|NCT00759603|O1|Outcome|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
509233|NCT00759603|E1|Reported Event|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
509234|NCT00759642|B1|Baseline|Lapatinib|"lapatinib
lapatinib: lapatinib 1500 mg PO daily"
509235|NCT00759642|P1|Participant Flow|Lapatinib|"lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)
lapatinib: lapatinib 1500 mg PO daily"
509236|NCT00759642|O1|Outcome|Lapatinib|"lapatinib + Endocrine therapy
lapatinib: lapatinib 1500 mg PO daily"
509237|NCT00759642|E1|Reported Event|Lapatinib|"lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)
lapatinib: lapatinib 1500 mg PO daily"
509238|NCT00759655|B1|Baseline|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
509239|NCT00759655|P1|Participant Flow|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
509240|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
509292|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
509243|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
509244|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
509245|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
509246|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
509247|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
509248|NCT00759655|E1|Reported Event|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
509249|NCT00759668|B3|Baseline|Total|Total of all reporting groups
509250|NCT00759668|B2|Baseline|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
509251|NCT00759668|B1|Baseline|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
509252|NCT00759668|P2|Participant Flow|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
509253|NCT00759668|P1|Participant Flow|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
509254|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
509255|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
509256|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
509257|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
509258|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
509259|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
509260|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
509261|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
509262|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
509263|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
509264|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
509265|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
509266|NCT00759668|E2|Reported Event|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
509267|NCT00759668|E1|Reported Event|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
509268|NCT00759681|B3|Baseline|Total|Total of all reporting groups
509269|NCT00759681|B2|Baseline|Investigational Device|Investigational Treatment: ArterX Surgical Sealant
509270|NCT00759681|B1|Baseline|Control|Control Treatment: Gelfoam and Thrombin
509271|NCT00759681|P2|Participant Flow|Investigational Device: ArterX Surgical Sealant|ArterX is a two-component sealant provided in a double barreled syringe. The main components are bovine serum albumin and a polyaldehyde formed from polymerized glutaraldehyde. The solutions are dispensed through a double plunger, mixing the two components in a 1:1 ratio by passing them through a specially designed mixing tip, delivering up to 2 ml volume of each component.
509272|NCT00759681|P1|Participant Flow|Control: Gelfoam and Thrombin|Gelfoam PlusTM is used to seal suture lines of arterial grafts or patches made from PTFE and Dacron. Gelfoam is a sterile compressed sponge and Thrombin is the last enzyme in the clotting cascade.
509273|NCT00759681|O2|Outcome|Investigational Device|Investigational Device: ArterX Surgical Sealant
509274|NCT00759681|O1|Outcome|Control Treatment|Control Treatment with Gelfoam and Thrombin
509275|NCT00759681|O2|Outcome|Investigational Device|Investigational Device: ArterX Surgical Sealant
509276|NCT00759681|O1|Outcome|Control Treatment|Control Treatment: Gelfoam and Thrombin
509277|NCT00759681|E2|Reported Event|1. ArterX Surgical Sealant|ArterX Surgical Sealant
509278|NCT00759681|E1|Reported Event|2. Gelfoam and Thrombin|Gelfoam and Thrombin
509279|NCT00759707|B1|Baseline|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
509280|NCT00759707|P1|Participant Flow|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
509281|NCT00759707|O1|Outcome|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
509282|NCT00759707|E1|Reported Event|Study Population|All 19 study subjects. Each subject qualified for the study on the basis of a continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein.
509283|NCT00759759|B3|Baseline|Total|Total of all reporting groups
509284|NCT00759759|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
509285|NCT00759759|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
509286|NCT00759759|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
509287|NCT00759759|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
509288|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
509293|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
509294|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
509295|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
509296|NCT00759759|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
509299|NCT00759772|B2|Baseline|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
509300|NCT00759772|B1|Baseline|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
509301|NCT00759772|P2|Participant Flow|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
509302|NCT00759772|P1|Participant Flow|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
509303|NCT00759772|O2|Outcome|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
509304|NCT00759772|O1|Outcome|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
509305|NCT00759772|E2|Reported Event|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
509306|NCT00759772|E1|Reported Event|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
509307|NCT00759785|B3|Baseline|Total|Total of all reporting groups
509308|NCT00759785|B2|Baseline|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509309|NCT00759785|B1|Baseline|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509310|NCT00759785|P2|Participant Flow|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509311|NCT00759785|P1|Participant Flow|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509312|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509313|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509314|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509315|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509316|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509317|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509318|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509319|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509320|NCT00759785|E2|Reported Event|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509321|NCT00759785|E1|Reported Event|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
509322|NCT00759811|B3|Baseline|Total|Total of all reporting groups
509323|NCT00759811|B2|Baseline|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
509324|NCT00759811|B1|Baseline|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
509325|NCT00759811|P2|Participant Flow|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
509326|NCT00759811|P1|Participant Flow|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
509327|NCT00759811|O2|Outcome|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
509328|NCT00759811|O1|Outcome|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
509329|NCT00759811|E2|Reported Event|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
509330|NCT00759811|E1|Reported Event|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
509331|NCT00759863|B3|Baseline|Total|Total of all reporting groups
509332|NCT00759863|B2|Baseline|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
509333|NCT00759863|B1|Baseline|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
509334|NCT00759863|P2|Participant Flow|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
509335|NCT00759863|P1|Participant Flow|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
509336|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
509337|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
509338|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
511629|NCT00756938|E4|Reported Event|Base Study-Losartan 1.4 mg/kg/Day|
509339|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
509340|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
509397|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
509341|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
509342|NCT00759863|E2|Reported Event|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
509343|NCT00759863|E1|Reported Event|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
509344|NCT00759902|B3|Baseline|Total|Total of all reporting groups
509345|NCT00759902|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
509346|NCT00759902|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
509347|NCT00759902|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
509348|NCT00759902|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
509349|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
509350|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
509351|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
509352|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
509353|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
509354|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
509355|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
509356|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
509357|NCT00759902|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
509358|NCT00759902|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
509359|NCT00759915|B3|Baseline|Total|Total of all reporting groups
509360|NCT00759915|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
509361|NCT00759915|B1|Baseline|Period 1: Treatment Aor B|Treatment A (test product) followed by Treatment B (reference product)
509362|NCT00759915|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
509363|NCT00759915|P1|Participant Flow|Period 1: Treatment Aor B|Treatment A (test product) followed by Treatment B (reference product)
509364|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
509365|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
509366|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
509367|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
509368|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
509369|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
509370|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
509371|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
509372|NCT00759915|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
509373|NCT00759915|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
509374|NCT00759941|B3|Baseline|Total|Total of all reporting groups
509375|NCT00759941|B2|Baseline|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
509376|NCT00759941|B1|Baseline|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
509377|NCT00759941|P2|Participant Flow|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
509378|NCT00759941|P1|Participant Flow|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
509379|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
509380|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
509381|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
509382|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
509383|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
509384|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
509385|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
509386|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
509387|NCT00759941|E2|Reported Event|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
509388|NCT00759941|E1|Reported Event|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
509389|NCT00759954|B3|Baseline|Total|Total of all reporting groups
509390|NCT00759954|B2|Baseline|Period 2: Treatment Aor B|Treatment B (reference product)followed by Treatment A (test product)
509391|NCT00759954|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
509392|NCT00759954|P2|Participant Flow|Period 2: Treatment Aor B|Treatment B (reference product)followed by Treatment A (test product)
509393|NCT00759954|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
509394|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
509395|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
509402|NCT00759954|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
509403|NCT00759954|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
509404|NCT00759967|B1|Baseline|All Participants|All patients in the study were randomized after the 3 month run in phase to either Conventional HD or Short Daily HD for 3 months and then crossed over to the other treatment arm for 3 months
509405|NCT00759967|P2|Participant Flow|Short Daily Hemodialysis First, Then Conventional Hemodialysis|"After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). Blood pressure was monitored according to the Canadian hypertension guidelines both pre and post each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 month period, extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
In this group 9 participants started and completed the first intervention: Short Daily Hemodialysis first (Period Table 1: Right Column). These 9 participants then started the second intervention: Conventional Hemodialysis (Period Table 2: Right Column). All 9 participants finished conventional dialysis."
509406|NCT00759967|P1|Participant Flow|Conventional Hemodialysis First, Then Short Daily Hemodialysis|"After a 3 month run-in period patients who are randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. BP was monitored according to the Canadian hypertension guidelines both pre and post each dialysis session. Antihypertensive medication were adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period, extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
In this group 10 participants started and completed the first intervention: Conventional Hemodialysis first (Period Table 1; Left Column). These 10 participants then started the second intervention: Short Daily Hemodialysis (Period Table 2: Left Column), of which 8 participants completed the Short Daily Hemodialysis."
509407|NCT00759967|O2|Outcome|Conventional Hemodialysis First, Then Short Daily Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 month period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
509408|NCT00759967|O1|Outcome|Short Daily Hemodialysis First, Then Conventional Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 month period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
509409|NCT00759967|O2|Outcome|Conventional Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
509410|NCT00759967|O1|Outcome|Short Daily Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
509411|NCT00759967|O2|Outcome|Conventional Hemodialysis First, Then Short Daily Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 month period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
509412|NCT00759967|O1|Outcome|Short Daily Hemodialysis First, Then Conventional Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 month period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
509428|NCT00760019|O2|Outcome|Placebo|Outcomes were measured at the end of each 4-week study period. Here, median flow-mediated, endothelium-dependent vasodilation after 4 weeks of 4.5 g/day salsalate is compared with median FMD after 4 weeks of matching placebo. Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls.
509413|NCT00759967|O2|Outcome|Conventional Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
509431|NCT00760019|E1|Reported Event|Salsalate|Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Salsalate
509432|NCT00760084|B1|Baseline|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
509414|NCT00759967|O1|Outcome|Short Daily Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
509415|NCT00759967|O2|Outcome|Conventional Hemodialysis|"After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
Below shows the results of the extracellular fluid volume"
509416|NCT00759967|O1|Outcome|Short Daily Hemodialysis|"After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
Below shows the results of the extracellular fluid volume"
509417|NCT00759967|O2|Outcome|Conventional Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
509418|NCT00759967|O1|Outcome|Short Daily Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
509419|NCT00759967|E2|Reported Event|Conventional Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines.At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
509420|NCT00759967|E1|Reported Event|Short Daily Hemodialysis|After a 3 month run-in period patients who are randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication wer adjusted accordingly to maintain BP within the guidelines.At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress will be collected.
509421|NCT00760019|B3|Baseline|Total|Total of all reporting groups
509422|NCT00760019|B2|Baseline|Healthy|"Participant flow is identical to that of NCT00762827 (The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome):
The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this control arm, healthy individuals received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks."
509423|NCT00760019|B1|Baseline|Atherosclerosis or Metabolic Syndrome|"Participant flow is identical to that of NCT00762827 (The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome):
The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this arm, individuals with either Metabolic Syndrome or Atherosclerosis received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks."
509424|NCT00760019|P4|Participant Flow|Healthy Subjects: Placebo First, Then Salsalate|Healthy subjects received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks.
509425|NCT00760019|P3|Participant Flow|Healthy Subjects: Salsalate First, Then Placebo|Healthy subjects received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks.
509426|NCT00760019|P2|Participant Flow|Atherosclerosis/Metabolic Syndrome: Placebo First, Then Salsal|Subjects with either Metabolic Syndrome/Atherosclerosis received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks.
509427|NCT00760019|P1|Participant Flow|Atherosclerosis/Metabolic Syndrome: Salsalate First, Then Plac|Subjects with either Metabolic Syndrome/Atherosclerosis received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks.
509465|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509586|NCT00762021|B2|Baseline|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
509429|NCT00760019|O1|Outcome|Salsalate|Outcomes were measured at the end of each 4-week study period. Here, median flow-mediated, endothelium-dependent vasodilation after 4 weeks of 4.5 g/day salsalate is compared with median FMD after 4 weeks of matching placebo. Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls.
509430|NCT00760019|E2|Reported Event|Placebo|Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Placebo
509433|NCT00760084|P1|Participant Flow|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
509434|NCT00760084|O1|Outcome|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
509435|NCT00760084|E1|Reported Event|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
509436|NCT00760214|B4|Baseline|Total|Total of all reporting groups
509437|NCT00760214|B3|Baseline|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509438|NCT00760214|B2|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509439|NCT00760214|B1|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509440|NCT00760214|P3|Participant Flow|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509441|NCT00760214|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509442|NCT00760214|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509443|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509444|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509445|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509446|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509447|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509448|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509449|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509450|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509451|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509452|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509453|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509454|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509455|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509456|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509457|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509458|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509459|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509460|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509461|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509462|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509463|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509464|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509466|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509467|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509468|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509469|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509594|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
509470|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509471|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509472|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509473|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509474|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509475|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509476|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509477|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509478|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509479|NCT00760214|E3|Reported Event|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
509480|NCT00760214|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
509481|NCT00760214|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
509482|NCT00760266|B3|Baseline|Total|Total of all reporting groups
509483|NCT00760266|B2|Baseline|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
509484|NCT00760266|B1|Baseline|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
509485|NCT00760266|P2|Participant Flow|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
509486|NCT00760266|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
509487|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
509488|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
509489|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
509490|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
509491|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
509492|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
509493|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
509494|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
509495|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
509496|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
509497|NCT00760266|E2|Reported Event|HCTZ|HCTZ 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
509498|NCT00760266|E1|Reported Event|Aliskiren / HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week, Aliskiren HCTZ 300/25 mg (with or without amlodipine): 7 weeks
509499|NCT00761735|B1|Baseline|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509500|NCT00761735|P1|Participant Flow|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509501|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (Male)|Male pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509502|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (Female)|Female pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509562|NCT00761930|E1|Reported Event|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
509503|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509504|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509568|NCT00761956|O2|Outcome|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
509505|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509506|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509507|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509508|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509509|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (All)|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509510|NCT00761735|E1|Reported Event|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
509511|NCT00761748|B1|Baseline|Overall Study Population|Urostomy operated subjects
509512|NCT00761748|P2|Participant Flow|ConvaTec 2 Piece,First, Then Sensura Uro 2 Piece|Convatec is the reference product and was chosen because of its similarity with the Sensura appliance.
509513|NCT00761748|P1|Participant Flow|Sensura Uro 2 Piece First, Then Convatec 2 Piece|Sensura is a newly developed two piece product for people with urostomies.
509514|NCT00761748|O2|Outcome|Convatec 2 Piece|The reference product Convatec 2 piece is a urostomy bag intended for collecting urin from a stoma.
509515|NCT00761748|O1|Outcome|Sensura Uro 2 Piece|The new SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
509516|NCT00761748|E2|Reported Event|Convatec 2 Piece|The reference product Convatec 2 piece is a urostomy bag intended for collecting urine from a stoma.
509517|NCT00761748|E1|Reported Event|Sensura Uro 2 Piece|SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
509518|NCT00761761|B3|Baseline|Total|Total of all reporting groups
509519|NCT00761761|B2|Baseline|Placebo|"Placebo
Placebo will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week and will be continued for a total of 8 weeks."
509520|NCT00761761|B1|Baseline|Sensoril|"Sensoril(Ashwagandha)
Sensoril: Sensoril® will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509521|NCT00761761|P2|Participant Flow|Placebo - 2|"Placebo
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509522|NCT00761761|P1|Participant Flow|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509523|NCT00761761|O2|Outcome|Placebo - 2|"Placebo
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509524|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509525|NCT00761761|O2|Outcome|Placebo - 2|"Placebo
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509526|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509527|NCT00761761|O2|Outcome|Placebo - 2|"Placebo
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509528|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509529|NCT00761761|O2|Outcome|Placebo|"Placebo
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509563|NCT00761956|B3|Baseline|Total|Total of all reporting groups
509530|NCT00761761|O1|Outcome|Sensoril|"Sensoril(Ashwagandha)
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509531|NCT00761761|E2|Reported Event|Placebo|"Placebo
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509532|NCT00761761|E1|Reported Event|Sensoril|"Sensoril(Ashwagandha)
Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
509533|NCT00761865|B3|Baseline|Total|Total of all reporting groups
509534|NCT00761865|B2|Baseline|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.
Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
509535|NCT00761865|B1|Baseline|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
509536|NCT00761865|P2|Participant Flow|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.
Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
509537|NCT00761865|P1|Participant Flow|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
509538|NCT00761865|O2|Outcome|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.
Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
509539|NCT00761865|O1|Outcome|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
509540|NCT00761865|O2|Outcome|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.
Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
509541|NCT00761865|O1|Outcome|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
509542|NCT00761865|E2|Reported Event|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.
Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
509543|NCT00761865|E1|Reported Event|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.
Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
509544|NCT00761930|B4|Baseline|Total|Total of all reporting groups
509545|NCT00761930|B3|Baseline|C - Experimental Toothpaste|fluoride/herbal toothpaste
509546|NCT00761930|B2|Baseline|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
509547|NCT00761930|B1|Baseline|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
509548|NCT00761930|P3|Participant Flow|C - Experimental Toothpaste|fluoride/herbal toothpaste
509549|NCT00761930|P2|Participant Flow|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
509550|NCT00761930|P1|Participant Flow|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
509551|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
509552|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
509553|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
509554|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
509555|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
509556|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
509557|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
509558|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
509559|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
509560|NCT00761930|E3|Reported Event|C - Experimental Toothpaste|fluoride/herbal toothpaste
509561|NCT00761930|E2|Reported Event|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
509564|NCT00761956|B2|Baseline|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
509565|NCT00761956|B1|Baseline|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
509566|NCT00761956|P2|Participant Flow|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
509567|NCT00761956|P1|Participant Flow|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
509569|NCT00761956|O1|Outcome|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
509570|NCT00761956|O2|Outcome|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
509571|NCT00761956|O1|Outcome|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
509572|NCT00761956|E2|Reported Event|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
509573|NCT00761956|E1|Reported Event|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
509574|NCT00761969|B3|Baseline|Total|Total of all reporting groups
509575|NCT00761969|B2|Baseline|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
509576|NCT00761969|B1|Baseline|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
509577|NCT00761969|P2|Participant Flow|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice ."
509578|NCT00761969|P1|Participant Flow|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice ."
509579|NCT00761969|O2|Outcome|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
509580|NCT00761969|O1|Outcome|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
509581|NCT00761969|O2|Outcome|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
509582|NCT00761969|O1|Outcome|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
509583|NCT00761969|E2|Reported Event|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
509584|NCT00761969|E1|Reported Event|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
509587|NCT00762021|B1|Baseline|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
509588|NCT00762021|P2|Participant Flow|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
509589|NCT00762021|P1|Participant Flow|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
509590|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
509591|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
509592|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
509593|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
509595|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
509596|NCT00762021|E2|Reported Event|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
509597|NCT00762021|E1|Reported Event|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
509598|NCT00762034|B3|Baseline|Total|Total of all reporting groups
509599|NCT00762034|B2|Baseline|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509600|NCT00762034|B1|Baseline|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509601|NCT00762034|P2|Participant Flow|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509602|NCT00762034|P1|Participant Flow|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509603|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509604|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509605|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509606|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509607|NCT00762034|O2|Outcome|TTF-1 Negative (H Score = 0)|"Participants who were TTF-1 Negative (H score = 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.
Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.
OR
Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
509728|NCT00762086|B2|Baseline|Control Group|Aspirin/Clopidegrol and Standard walking exercises
509608|NCT00762034|O1|Outcome|TTF-1 Positive (H Score > 0)|"Participants who were TTF-1 Positive (H score > 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.
Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.
OR
Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
509669|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509739|NCT00762164|P2|Participant Flow|Simvastatin|Simvastatin 20 milligrams
509609|NCT00762034|O1|Outcome|Pem or Pac Plus Carbo/Bev|"Participants who received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.
Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.
OR
Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
509610|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509611|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509612|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509613|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509614|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509615|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509616|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509617|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509618|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509663|NCT00762073|P4|Participant Flow|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509729|NCT00762086|B1|Baseline|Treatment Group|AngioPress IPC Device
509670|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
509671|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509619|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509620|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509621|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509622|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509623|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509624|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509625|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509626|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509627|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509628|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509664|NCT00762073|P3|Participant Flow|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509629|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev)followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509630|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509631|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509632|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509633|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509634|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509635|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509636|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509637|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509638|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509665|NCT00762073|P2|Participant Flow|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509666|NCT00762073|P1|Participant Flow|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
509730|NCT00762086|P2|Participant Flow|Control Group|Aspirin/Clopidegrol and Standard walking exercises
509639|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509640|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509641|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509642|NCT00762034|O4|Outcome|Pac/Carbo/Bev; Maintenance Phase|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509643|NCT00762034|O3|Outcome|Pac/Carbo/Bev; Induction Phase|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509644|NCT00762034|O2|Outcome|Pem/Carbo/Bev; Maintenance Phase|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509645|NCT00762034|O1|Outcome|Pem/Carbo/Bev; Induction Phase|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509646|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509647|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509648|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509667|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509668|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509649|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509650|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509651|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509652|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509653|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509654|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509655|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
509656|NCT00762034|E2|Reported Event|Pac/Carbo/Bev|"Induction:
Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m ²) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days
Maintenance:
Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation."
509657|NCT00762034|E1|Reported Event|Pem/Carbo/Bev|"Induction:
Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days
Maintenance:
Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation."
509658|NCT00762073|B5|Baseline|Total|Total of all reporting groups
509659|NCT00762073|B4|Baseline|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509660|NCT00762073|B3|Baseline|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509661|NCT00762073|B2|Baseline|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509662|NCT00762073|B1|Baseline|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
509726|NCT00762073|E1|Reported Event|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
509672|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509673|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509674|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
509675|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
509676|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
509677|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
509678|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
509679|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
509680|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
509681|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
509682|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
509683|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
509684|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
509685|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
509686|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
509687|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509688|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509689|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509690|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
509691|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509692|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509693|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509694|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
509695|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509696|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509727|NCT00762086|B3|Baseline|Total|Total of all reporting groups
509697|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509698|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
509699|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509700|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509701|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509702|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
509703|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509704|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509705|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509706|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
509707|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509708|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509709|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509710|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
509711|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509712|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509713|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509714|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
509715|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509716|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509717|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509718|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
509719|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
509720|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
509721|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
509722|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
509723|NCT00762073|E4|Reported Event|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
509724|NCT00762073|E3|Reported Event|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
509725|NCT00762073|E2|Reported Event|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
509731|NCT00762086|P1|Participant Flow|Treatment Group|AngioPress IPC Device
509732|NCT00762086|O2|Outcome|Control Group|Aspirin/Clopidegrol and Standard walking exercises
509733|NCT00762086|O1|Outcome|Treatment Group|AngioPress IPC Device
509734|NCT00762086|E2|Reported Event|Control Group|Aspirin/Clopidegrol and Standard walking exercises
509735|NCT00762086|E1|Reported Event|Treatment Group|AngioPress IPC Device
509736|NCT00762164|B3|Baseline|Total|Total of all reporting groups
509737|NCT00762164|B2|Baseline|Simvastatin|Simvastatin 20 milligrams
509738|NCT00762164|B1|Baseline|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
509740|NCT00762164|P1|Participant Flow|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
509741|NCT00762164|O2|Outcome|Simvastatin|Simvastatin 20 milligrams
509742|NCT00762164|O1|Outcome|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
509743|NCT00762164|O2|Outcome|Simvastatin|Simvastatin 20 milligrams
509744|NCT00762164|O1|Outcome|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
509745|NCT00762164|E2|Reported Event|Simvastatin|Simvastatin 20 milligrams
509746|NCT00762164|E1|Reported Event|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
509747|NCT00762177|B4|Baseline|Total|Total of all reporting groups
509748|NCT00762177|B3|Baseline|Experimental 1st, Placebo 2nd, Active Comparator 3rd|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention.
509749|NCT00762177|B2|Baseline|Active Comparator 1st, Experimental 2nd, Placebo 3rd|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention.
509750|NCT00762177|B1|Baseline|Placebo 1st, Active Comparator 2nd and Experimental 3rd|Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention.
509751|NCT00762177|P3|Participant Flow|Experimental 1st, Placebo 2nd, Active Comparator 3rd|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention.
509752|NCT00762177|P2|Participant Flow|Active Comparator 1st, Experimental 2nd, Placebo 3rd|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention.
509753|NCT00762177|P1|Participant Flow|Placebo 1st, Active Comparator 2nd and Experimental 3rd|Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention.
509754|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509755|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509756|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509757|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509758|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509759|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509760|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509761|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509762|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509763|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509764|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509765|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509766|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509767|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509768|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509769|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509770|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509771|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509772|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509773|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509774|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509775|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509776|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509777|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509778|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509779|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509780|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509781|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509782|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509783|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509784|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509785|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509786|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509787|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509788|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509789|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509790|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509791|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509792|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509793|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509794|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509795|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509796|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509797|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509798|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509799|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509800|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509801|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509802|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509803|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509804|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509805|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509806|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509807|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509808|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509809|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509810|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509811|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509812|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509813|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509814|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509815|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509816|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509817|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509818|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509819|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509820|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
509821|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
509822|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only)
509823|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
510094|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
509824|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).
509825|NCT00762177|O1|Outcome|Placebo Toothpaste|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
509826|NCT00762177|E3|Reported Event|Experimental|Experimental test product (stannous fluoride toothpaste)
509827|NCT00762177|E2|Reported Event|Active Comparator|Active Comparator toothpaste containing fluoride/triclosan/copolymer (Total)
509828|NCT00762177|E1|Reported Event|Placebo - Fluoride Control|Fluoride only toothpaste (Crest Anti-Cavity)
509829|NCT00762216|B1|Baseline|Toric|Implantation with the AcrySof® Toric intraocular lens
509830|NCT00762216|P1|Participant Flow|Toric|Implantation with the AcrySof® Toric intraocular lens
509831|NCT00762216|O1|Outcome|Toric|Implantation with the AcrySof® Toric intraocular lens
509832|NCT00762216|O1|Outcome|Toric|Implantation with the AcrySof® Toric intraocular lens
509833|NCT00762216|E1|Reported Event|Toric|Implantation with the AcrySof® Toric intraocular lens
509834|NCT00762229|B3|Baseline|Total|Total of all reporting groups
509835|NCT00762229|B2|Baseline|Ezetimibe 5 mg|Ezetimibe 5 mg,
509836|NCT00762229|B1|Baseline|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
509837|NCT00762229|P2|Participant Flow|Ezetimibe 5 mg|Ezetimibe 5 mg,
509838|NCT00762229|P1|Participant Flow|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
509839|NCT00762229|O2|Outcome|Ezetimibe 5 mg|Ezetimibe 5 mg,
509840|NCT00762229|O1|Outcome|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
509841|NCT00762229|O2|Outcome|Ezetimibe 5 mg|Ezetimibe 5 mg,
509842|NCT00762229|O1|Outcome|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
509843|NCT00762229|E2|Reported Event|Ezetimibe 5 mg|Ezetimibe 5 mg,
509844|NCT00762229|E1|Reported Event|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
509845|NCT00762268|B3|Baseline|Total|Total of all reporting groups
509846|NCT00762268|B2|Baseline|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
509847|NCT00762268|B1|Baseline|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
509848|NCT00762268|P2|Participant Flow|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
509849|NCT00762268|P1|Participant Flow|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
509850|NCT00762268|O2|Outcome|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
509851|NCT00762268|O1|Outcome|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
509852|NCT00762268|E2|Reported Event|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
509853|NCT00762268|E1|Reported Event|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
509854|NCT00762320|B1|Baseline|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra
Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
509855|NCT00762320|P1|Participant Flow|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra
Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
509856|NCT00762320|O2|Outcome|Low Dose Kaletra Week 4|Patients Receiving Low Dose Kaletra at Week 4
509857|NCT00762320|O1|Outcome|Low Dose Kaletra Baseline|Patients receiving Low Dose Kaletra at baseline
509858|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
509859|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
509860|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
509861|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra
509862|NCT00762320|O2|Outcome|Low Dose Kaletra Week 4 Visit|Patient Satisfaction Score at Week 4 visit
509863|NCT00762320|O1|Outcome|Low Dose Kaletra Baseline Visit|Patient satisfaction score at baseline visit
509864|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
509865|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
509866|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
509867|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
509868|NCT00762320|E1|Reported Event|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra
Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
509869|NCT00762359|B3|Baseline|Total|Total of all reporting groups
509870|NCT00762359|B2|Baseline|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509871|NCT00762359|B1|Baseline|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509872|NCT00762359|P2|Participant Flow|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509873|NCT00762359|P1|Participant Flow|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
510101|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
509874|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509875|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509876|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509877|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509878|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509879|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509880|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509881|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509882|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509883|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509884|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509885|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509886|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509887|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509888|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509889|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509890|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509891|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509892|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509893|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509894|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509895|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509896|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509897|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509898|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509899|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509900|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509901|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509902|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509903|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509904|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509905|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509906|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509907|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509908|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509909|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509910|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509911|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509912|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509913|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509914|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509915|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509916|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509917|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509918|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509919|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509920|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509921|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509922|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509923|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509924|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509925|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509926|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509927|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509928|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509929|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509930|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509931|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509932|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509933|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509934|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509935|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509936|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509937|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509938|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509939|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509940|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509941|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509942|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509943|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509944|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509945|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509946|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509947|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509948|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509949|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509950|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509951|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509952|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509953|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509954|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509955|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509956|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509957|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509958|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509959|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509960|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509961|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509962|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509963|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509964|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509965|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509966|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509967|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509968|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509969|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509970|NCT00762359|E2|Reported Event|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
509971|NCT00762359|E1|Reported Event|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
509972|NCT00762385|B1|Baseline|Completed Population|Includes subjects randomized to galyfilcon A/comfilcon A and comfilcon A/galyfilcon A and that completed the study.
509973|NCT00762385|P2|Participant Flow|Comfilcon A / Galyfilcon A|comfilcon A contact lenses first period, galyfilcon A contact lenses second period
509974|NCT00762385|P1|Participant Flow|Galyfilcon A / Comfilcon A|galyfilcon A contact lenses first period, comfilcon a contact lenses second period
509975|NCT00762385|O2|Outcome|Comfilcon A|comfilcon A administered in either the first intervention period or the second intervention period.
509976|NCT00762385|O1|Outcome|Galyfilcon A|galyfilcon A administered in either the first intervention period or the second intervention period.
509977|NCT00762385|O2|Outcome|Comfilcon A|
509978|NCT00762385|O1|Outcome|Galyfilcon A|
509979|NCT00762385|O2|Outcome|Comfilcon A|comfilcon A administered in either the first intervention period or second intervention period.
509980|NCT00762385|O1|Outcome|Galyfilcon A|galyfilcon A administered in either the first intervention period or the second intervention period.
509981|NCT00762385|E2|Reported Event|Comfilcon A / Galyfilcon A|comfilcon A contact lenses first period, galyfilcon A contact lenses second period
509982|NCT00762385|E1|Reported Event|Galyfilcon A / Comfilcon A|galyfilcon A contact lenses first period, comfilcon a contact lenses second period
509983|NCT00762411|B3|Baseline|Total|Total of all reporting groups
510095|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
509984|NCT00762411|B2|Baseline|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
509985|NCT00762411|B1|Baseline|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
509986|NCT00762411|P2|Participant Flow|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510102|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
509987|NCT00762411|P1|Participant Flow|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
509988|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
509989|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
509990|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
509991|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
509992|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
509993|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
509994|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
509995|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
509996|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
509997|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
509998|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
509999|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510000|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510001|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510002|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510003|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510004|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510005|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510006|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510007|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510008|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510009|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510010|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510011|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510012|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510013|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510096|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510151|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510014|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510015|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510016|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510017|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510018|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510019|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510020|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510021|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510022|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510023|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510024|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510025|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510026|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510027|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510028|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510029|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510030|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510031|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510032|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510033|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510034|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510035|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510036|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510037|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510038|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510039|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510040|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510041|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510042|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
510043|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510149|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510150|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510044|NCT00762411|E6|Reported Event|140 mg LY450139 - SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
510045|NCT00762411|E5|Reported Event|Placebo-Safety Follow Up Period (SFU)|For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.
510046|NCT00762411|E4|Reported Event|140 mg LY450139- DO|After Week 76, participants received 140 mg LY450139 orally once daily until Week 88.
510047|NCT00762411|E3|Reported Event|Placebo- (Delayed Start Period [DO])|After Week 76, participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
510048|NCT00762411|E2|Reported Event|140 mg LY450139- NT|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 76.
510049|NCT00762411|E1|Reported Event|Placebo- (Initial Treatment Period [NT])|Participants received placebo orally once daily for the first 76 weeks.
510050|NCT00762424|B3|Baseline|Total|Total of all reporting groups
510051|NCT00762424|B2|Baseline|Placebo|placebo: cornstarch
510052|NCT00762424|B1|Baseline|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
510053|NCT00762424|P2|Participant Flow|Placebo|placebo: cornstarch
510054|NCT00762424|P1|Participant Flow|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
510055|NCT00762424|O2|Outcome|Placebo|placebo: cornstarch
510056|NCT00762424|O1|Outcome|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
510057|NCT00762424|E2|Reported Event|Placebo|placebo: cornstarch
510058|NCT00762424|E1|Reported Event|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
510059|NCT00762450|B4|Baseline|Total|Total of all reporting groups
510060|NCT00762450|B3|Baseline|Experimental First, Placebo Second and Positive Control Last|
510061|NCT00762450|B2|Baseline|Positive Control First, Experimental Second and Placebo Last|
510062|NCT00762450|B1|Baseline|Placebo First, Positive Control Second and Experimental Last|
510063|NCT00762450|P3|Participant Flow|Experimental 1st, Placebo 2nd and Active Comparator Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
510064|NCT00762450|P2|Participant Flow|Active Comparator 1st, Experimental 2nd and Placebo Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
510065|NCT00762450|P1|Participant Flow|Placebo 1st, Active Comparator 2nd and Experimental Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
510066|NCT00762450|O3|Outcome|Experimental Toothpaste|
510067|NCT00762450|O2|Outcome|Placebo - Silica Control|
510068|NCT00762450|O1|Outcome|Active Comparator|
510069|NCT00762450|E3|Reported Event|Experimental First, Placebo Second and Positive Control Last|
510070|NCT00762450|E2|Reported Event|Positive Control First, Experimental Second and Placebo Last|
510071|NCT00762450|E1|Reported Event|Placebo First, Positive Control Second and Experimental Last|
510072|NCT00762463|B3|Baseline|Total|Total of all reporting groups
510073|NCT00762463|B2|Baseline|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510074|NCT00762463|B1|Baseline|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510075|NCT00762463|P4|Participant Flow|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510076|NCT00762463|P3|Participant Flow|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510077|NCT00762463|P2|Participant Flow|Diclofenac SR 75 mg|Diclofenac sustained release (SR) 75 mg tablet once daily
510078|NCT00762463|P1|Participant Flow|Celecoxib 200 mg|Celecoxib 200 milligram (mg) capsule once daily
510079|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510080|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510081|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510082|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510083|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510084|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510085|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510086|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510087|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510088|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510089|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510090|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510091|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510092|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510093|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510097|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510098|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510099|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510100|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510103|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510104|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510105|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510106|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510107|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510108|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510109|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510110|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510111|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510112|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510113|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510114|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510115|NCT00762463|O4|Outcome|Diclofenac 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 and Celecoxib 400 mg once daily from Week 6 to Week 12
510116|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510117|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510118|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510119|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510120|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510121|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510122|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510123|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510124|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510125|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510126|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510127|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510128|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510129|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510130|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510131|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510132|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510133|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510134|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510135|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510136|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510137|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510138|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510139|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510140|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510141|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510142|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510143|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510144|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510145|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510146|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510147|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
510148|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510152|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
510153|NCT00762463|E6|Reported Event|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510154|NCT00762463|E5|Reported Event|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
510155|NCT00762463|E4|Reported Event|Diclofenac SR 75 mg, Then Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Diclofenac SR 75 mg tablet once daily from Week 6 to Week 12
510193|NCT00762515|P1|Participant Flow|A -Placebo Comparator|Fluoride toothpaste
510156|NCT00762463|E3|Reported Event|Celecoxib 200 mg, Then Celecoxib 200 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 200 mg capsule once daily from Week 6 to Week 12
510157|NCT00762463|E2|Reported Event|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6
510158|NCT00762463|E1|Reported Event|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6
510159|NCT00762476|B3|Baseline|Total|Total of all reporting groups
510160|NCT00762476|B2|Baseline|3804-250A|Experimental AV Lotion
510161|NCT00762476|B1|Baseline|Placebo|Modified AV Lotion without active ingredients.
510162|NCT00762476|P2|Participant Flow|3804-250A|Experimental AV Lotion
510163|NCT00762476|P1|Participant Flow|Placebo|Modified AV Lotion without active ingredients.
510164|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
510165|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients.
510166|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
510167|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients.
510168|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
510169|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients
510170|NCT00762476|E2|Reported Event|3804-250A|Experimental AV Lotion
510171|NCT00762476|E1|Reported Event|Placebo|Modified AV Lotion without active ingredients.
510172|NCT00762502|B4|Baseline|Total|Total of all reporting groups
510173|NCT00762502|B3|Baseline|Senofilcon A/Balafilcon A Contralaterally|senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
510174|NCT00762502|B2|Baseline|Balafilcon A Toric Bilaterally|balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
510175|NCT00762502|B1|Baseline|Senofilcon A Toric Bilaterally|senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
510176|NCT00762502|P3|Participant Flow|Senofilcon A Toric/Balafilcon A Toric Contralaterally|Senofilcon A toric lens worn in one eye and Balafilcon A toric lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
510177|NCT00762502|P2|Participant Flow|Balafilcon A Bilaterally|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
510178|NCT00762502|P1|Participant Flow|Senofilcon A Bilaterally|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
510179|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
510180|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
510181|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
510182|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
510183|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
510184|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
510185|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
510186|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
510187|NCT00762502|E2|Reported Event|Balafilcon A|balafilcon A lenses (control) worn daily bilaterally (in both eyes) for 6months, replaced weekly OR balifilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
510253|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510254|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510188|NCT00762502|E1|Reported Event|Senofilcon A|senofilcon A lenses (test) worn daily bilaterally (in both eyes) for 6 months, replaced weekly OR senofilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
510189|NCT00762515|B3|Baseline|Total|Total of all reporting groups
510190|NCT00762515|B2|Baseline|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
510191|NCT00762515|B1|Baseline|A -Placebo Comparator|Fluoride toothpaste
510192|NCT00762515|P2|Participant Flow|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
510194|NCT00762515|O2|Outcome|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
510195|NCT00762515|O1|Outcome|A -Placebo Comparator|Fluoride toothpaste
510196|NCT00762515|O2|Outcome|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
510197|NCT00762515|O1|Outcome|A -Placebo Comparator|Fluoride toothpaste
510198|NCT00762515|E2|Reported Event|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
510199|NCT00762515|E1|Reported Event|A -Placebo Comparator|Fluoride toothpaste
510200|NCT00762528|B3|Baseline|Total|Total of all reporting groups
510201|NCT00762528|B2|Baseline|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
510202|NCT00762528|B1|Baseline|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
510203|NCT00762528|P2|Participant Flow|Fluoride Toothpaste|Sodium monofluorophosphate toothpaste
510204|NCT00762528|P1|Participant Flow|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
510205|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
510206|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
510207|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
510208|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
510209|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
510210|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
510211|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
510212|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
510213|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
510214|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
510215|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
510216|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
510217|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
510218|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
510219|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
510220|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
510221|NCT00762528|E2|Reported Event|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
510222|NCT00762528|E1|Reported Event|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
510223|NCT00762606|B3|Baseline|Total|Total of all reporting groups
510224|NCT00762606|B2|Baseline|SICS|Small incision cataract surgery (SICS)
510225|NCT00762606|B1|Baseline|Phaco|cataract extraction surgery utilizing Phacoemulsification
510226|NCT00762606|P2|Participant Flow|SICS|Small incision cataract surgery (SICS)
510227|NCT00762606|P1|Participant Flow|Phaco|cataract extraction surgery utilizing Phacoemulsification
510228|NCT00762606|O2|Outcome|SICS|Small incision cataract surgery (SICS)
510229|NCT00762606|O1|Outcome|Phaco|cataract extraction surgery utilizing Phacoemulsification
510230|NCT00762606|O2|Outcome|SICS|Small incision cataract surgery (SICS)
510231|NCT00762606|O1|Outcome|Phaco|cataract extraction surgery utilizing Phacoemulsification
510232|NCT00762606|E2|Reported Event|SICS|Small incision cataract surgery (SICS)
510233|NCT00762606|E1|Reported Event|Phaco|cataract extraction surgery utilizing Phacoemulsification
510234|NCT00762619|B3|Baseline|Total|Total of all reporting groups
510235|NCT00762619|B2|Baseline|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510236|NCT00762619|B1|Baseline|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510237|NCT00762619|P2|Participant Flow|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510238|NCT00762619|P1|Participant Flow|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510239|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510240|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510241|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510242|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510243|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510244|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510245|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510246|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510247|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510248|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510249|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510250|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510251|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510252|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510255|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510256|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510257|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510258|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510259|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510260|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510261|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510262|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510263|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510264|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510265|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510266|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510267|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510268|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510269|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510270|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510271|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510272|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510273|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510274|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510275|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510276|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510277|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510278|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510279|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510280|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510281|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510282|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510283|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510284|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510285|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510286|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510287|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510288|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510289|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510290|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510291|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510292|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510293|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510294|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510295|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510296|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510297|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510298|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510299|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510300|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510301|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510302|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510303|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510304|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510305|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510306|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510307|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510308|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510309|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510310|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510311|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510312|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510313|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510314|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510315|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510316|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510317|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510318|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510319|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510320|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510321|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510322|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510323|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510324|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510325|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510326|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510377|NCT00762645|B3|Baseline|Total|Total of all reporting groups
510327|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510328|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510329|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510330|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510331|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510332|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510333|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510334|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510335|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510336|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510337|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510338|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510339|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510340|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510341|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510342|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510343|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510344|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510345|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510346|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510347|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510348|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510349|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
510350|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
510351|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510352|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510353|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510354|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510355|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510356|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510357|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510358|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510359|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510360|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510361|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510362|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510363|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510364|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510365|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510366|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510367|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510368|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510369|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510370|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510371|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510372|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510373|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510374|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510375|NCT00762619|E2|Reported Event|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510376|NCT00762619|E1|Reported Event|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
510378|NCT00762645|B2|Baseline|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
510379|NCT00762645|B1|Baseline|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
510380|NCT00762645|P2|Participant Flow|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
510381|NCT00762645|P1|Participant Flow|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
510382|NCT00762645|O2|Outcome|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
510383|NCT00762645|O1|Outcome|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
510384|NCT00762645|O2|Outcome|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
510385|NCT00762645|O1|Outcome|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
510386|NCT00762645|E2|Reported Event|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
510387|NCT00762645|E1|Reported Event|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
510388|NCT00762723|B4|Baseline|Total|Total of all reporting groups
510389|NCT00762723|B3|Baseline|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510390|NCT00762723|B2|Baseline|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510391|NCT00762723|B1|Baseline|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510392|NCT00762723|P3|Participant Flow|ALP With Hybrid Screws|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510393|NCT00762723|P2|Participant Flow|ALP With Variable Screws|"Trinica Anterior Lumbar Plate System with variable screws only
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510394|NCT00762723|P1|Participant Flow|ALP With Fixed Screws|"Trinica Anterior Lumbar Plate System with fixed screws only
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510395|NCT00762723|O3|Outcome|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510396|NCT00762723|O2|Outcome|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510397|NCT00762723|O1|Outcome|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510398|NCT00762723|E3|Reported Event|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510399|NCT00762723|E2|Reported Event|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510400|NCT00762723|E1|Reported Event|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
510401|NCT00762762|B3|Baseline|Total|Total of all reporting groups
510402|NCT00762762|B2|Baseline|Placebo Comparator|Anti-cavity, fluoride oral rinse
510403|NCT00762762|B1|Baseline|Active Comparator|triclosan/fluoride/copolymer toothpaste
510404|NCT00762762|P2|Participant Flow|Placebo Comparator|Anti-cavity, fluoride oral rinse
512593|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
510405|NCT00762762|P1|Participant Flow|Active Comparator|triclosan/fluoride/copolymer toothpaste
510406|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
510407|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
510408|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
510409|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
510410|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
510411|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
510412|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
510413|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
510414|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
510415|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
510416|NCT00762762|E2|Reported Event|Placebo Comparator|Anti-cavity, fluoride oral rinse
510417|NCT00762762|E1|Reported Event|Active Comparator|triclosan/fluoride/copolymer toothpaste
510418|NCT00762788|B7|Baseline|Total|Total of all reporting groups
510419|NCT00762788|B6|Baseline|Etafilcon A Contact Lens|ACUVUE 2
510420|NCT00762788|B5|Baseline|Comfilcon A Contact Lens|Biofinity
510421|NCT00762788|B4|Baseline|Balafilcon A Contact Lens|PureVision
510422|NCT00762788|B3|Baseline|Lotrafilcon B Contact Lens|O2Optix
510423|NCT00762788|B2|Baseline|Lotrafilcon A Contact Lens|NIGHT&DAY
510424|NCT00762788|B1|Baseline|Senofilcon A Contact Lens|ACUVUE OASYS
510425|NCT00762788|P6|Participant Flow|Etafilcon A Contact Lens|ACUVUE 2
510426|NCT00762788|P5|Participant Flow|Comfilcon A Contact Lens|Biofinity
510427|NCT00762788|P4|Participant Flow|Balafilcon A Contact Lens|PureVision
510428|NCT00762788|P3|Participant Flow|Lotrafilcon B Contact Lens|O2Optix
510429|NCT00762788|P2|Participant Flow|Lotrafilcon A Contact Lens|NIGHT&DAY
510430|NCT00762788|P1|Participant Flow|Senofilcon A Contact Lens|ACUVUE OASYS
510431|NCT00762788|O6|Outcome|Etafilcon A Contact Lens|ACUVUE 2
510432|NCT00762788|O5|Outcome|Comfilcon A Contact Lens|Biofinity
510433|NCT00762788|O4|Outcome|Balafilcon A Contact Lens|PureVision
510434|NCT00762788|O3|Outcome|Lotrafilcon B Contact Lens|O2Optix
510435|NCT00762788|O2|Outcome|Lotrafilcon A Contact Lens|NIGHT&DAY
510436|NCT00762788|O1|Outcome|Senofilcon A Contact Lens|ACUVUE OASYS
510437|NCT00762788|O6|Outcome|Etafilcon A Contact Lens|ACUVUE 2
510438|NCT00762788|O5|Outcome|Comfilcon A Contact Lens|Biofinity
510439|NCT00762788|O4|Outcome|Balafilcon A Contact Lens|PureVision
510440|NCT00762788|O3|Outcome|Lotrafilcon B Contact Lens|O2Optix
510441|NCT00762788|O2|Outcome|Lotrafilcon A Contact Lens|NIGHT&DAY
510442|NCT00762788|O1|Outcome|Senofilcon A Contact Lens|ACUVUE OASYS
510443|NCT00762788|E6|Reported Event|Etafilcon A Contact Lens|ACUVUE 2
510444|NCT00762788|E5|Reported Event|Comfilcon A Contact Lens|Biofinity
510445|NCT00762788|E4|Reported Event|Balafilcon A Contact Lens|PureVision
510446|NCT00762788|E3|Reported Event|Lotrafilcon B Contact Lens|O2Optix
510447|NCT00762788|E2|Reported Event|Lotrafilcon A Contact Lens|NIGHT&DAY
510448|NCT00762788|E1|Reported Event|Senofilcon A Contact Lens|ACUVUE OASYS
510449|NCT00762853|B3|Baseline|Total|Total of all reporting groups
510450|NCT00762853|B2|Baseline|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
510451|NCT00762853|B1|Baseline|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
510452|NCT00762853|P2|Participant Flow|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
510453|NCT00762853|P1|Participant Flow|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
510454|NCT00762853|O2|Outcome|Active Toothpaste|fluoride/triclosan/copolymer(Active) toothpaste
510455|NCT00762853|O1|Outcome|Fluoride Toothpaste (Placebo)|fluoride only toothpaste
510456|NCT00762853|E2|Reported Event|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
510457|NCT00762853|E1|Reported Event|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
510458|NCT00762892|B3|Baseline|Total|Total of all reporting groups
510459|NCT00762892|B2|Baseline|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
510460|NCT00762892|B1|Baseline|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)
Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
510461|NCT00762892|P2|Participant Flow|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
510462|NCT00762892|P1|Participant Flow|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)
Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
510463|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
510585|NCT00763243|O3|Outcome|Posttraining Visit|Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
510464|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)
Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
510465|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
510466|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)
Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
510467|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
510468|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)
Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
510469|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
510470|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)
Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
510471|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
510472|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)
Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
510473|NCT00762892|E2|Reported Event|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
510474|NCT00762892|E1|Reported Event|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)
Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
510475|NCT00762970|B4|Baseline|Total|Total of all reporting groups
510476|NCT00762970|B3|Baseline|Control Lens|Spectacle lenses worn daily.
510477|NCT00762970|B2|Baseline|Test Lens 2|Investigational soft contact lens worn daily.
510478|NCT00762970|B1|Baseline|Test Lens 1|Investigational soft contact lens worn daily.
510479|NCT00762970|P3|Participant Flow|Control Lens|Control spectacle lenses worn daily.
510480|NCT00762970|P2|Participant Flow|Test Lens 2|Investigational soft contact lenses worn daily.
510481|NCT00762970|P1|Participant Flow|Test Lens 1|Investigational soft contact lenses worn daily.
510482|NCT00762970|O3|Outcome|Control Lens|Spectacle lenses worn daily.
510483|NCT00762970|O2|Outcome|Test Lens 2|Investigational soft contact lenses worn daily.
510484|NCT00762970|O1|Outcome|Test Lens 1|Investigational soft contact lenses worn daily.
510485|NCT00762970|O3|Outcome|Control Lens|Spectacle lenses worn daily.
510486|NCT00762970|O2|Outcome|Test Lens 2|Investigational soft contact lenses worn daily.
510487|NCT00762970|O1|Outcome|Test Lens 1|Investigational soft contact lenses worn daily.
510488|NCT00762970|E3|Reported Event|Control Lens|Control spectacle lenses worn daily.
510489|NCT00762970|E2|Reported Event|Test Lens 2|Investigational soft contact lenses worn daily.
510490|NCT00762970|E1|Reported Event|Test Lens 1|Investigational soft contact lenses worn daily.
510491|NCT00762996|B1|Baseline|Entire Population|
510492|NCT00762996|P4|Participant Flow|Omafilcon A / Omafilcon A|Period 1: omafilcon A, Period 2: omafilcon A
510493|NCT00762996|P3|Participant Flow|Omafilcon A / Etafilcon A|Period 1: omafilcon A, Period 2: etafilcon A
510494|NCT00762996|P2|Participant Flow|Etafilcon A / Omafilcon A|Period 1: etafilcon A, Period 2: omafilcon A
510495|NCT00762996|P1|Participant Flow|Etafilcon A / Etafilcon A|Period 1: etafilcon A, Period 2: etafilcon A
510496|NCT00762996|O2|Outcome|Omafilcon A|
510497|NCT00762996|O1|Outcome|Etafilcon A|
510498|NCT00762996|O2|Outcome|Omafilcon A|
510499|NCT00762996|O1|Outcome|Etafilcon A|
510500|NCT00762996|E4|Reported Event|Omafilcon A / Omafilcon A|Period 1: omafilcon A, Period 2: omafilcon A
510501|NCT00762996|E3|Reported Event|Omafilcon A / Etafilcon A|Period 1: omafilcon A, Period 2: etafilcon A
510502|NCT00762996|E2|Reported Event|Etafilcon A / Omafilcon A|Period 1: etafilcon A, Period 2: omafilcon A
510503|NCT00762996|E1|Reported Event|Etafilcon A / Etafilcon A|Period 1: etafilcon A, Period 2: etafilcon A
510504|NCT00763009|B1|Baseline|Dipyridamole|Pre Results prior to Dipyridamole Post: Results post Dipyridamole
510505|NCT00763009|P1|Participant Flow|All Subjects Receive Dipyridamole|"There is only a single arm
dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
510506|NCT00763009|O1|Outcome|All Subjects Receive Dipyridamole|"There is only a single arm
dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
510507|NCT00763009|E1|Reported Event|All Subjects Receive Dipyridamole|"There is only a single arm
dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
510508|NCT00763048|B3|Baseline|Total|Total of all reporting groups
510509|NCT00763048|B2|Baseline|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510510|NCT00763048|B1|Baseline|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510511|NCT00763048|P2|Participant Flow|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510512|NCT00763048|P1|Participant Flow|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510513|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510514|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510515|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510516|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510517|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510518|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510798|NCT00763867|B2|Baseline|Sildenafil|20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
510519|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510520|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510521|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510522|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510523|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510524|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510525|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510526|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510527|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510528|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510529|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510530|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510531|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510532|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510533|NCT00763048|E2|Reported Event|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
510534|NCT00763048|E1|Reported Event|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
510535|NCT00763061|B3|Baseline|Total|Total of all reporting groups
510536|NCT00763061|B2|Baseline|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
510537|NCT00763061|B1|Baseline|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
510538|NCT00763061|P2|Participant Flow|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
510539|NCT00763061|P1|Participant Flow|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
510540|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
510541|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
510542|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
510543|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
510544|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
510545|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
510546|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
510547|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
510548|NCT00763061|E2|Reported Event|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
510549|NCT00763061|E1|Reported Event|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
510550|NCT00763139|B1|Baseline|Baseline Characteristics of Participants|participants who met American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA), age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month
510551|NCT00763139|P2|Participant Flow|Pioglitazone 1st, Placebo 2nd|"Pioglitazone for first 8 weeks, then washout period for 4 weeks, and finally placebo for 8 weeks.
Pioglitazone: 45 mg by mouth once a day for 8 weeks
Placebo: By mouth once a day for 8 weeks"
510552|NCT00763139|P1|Participant Flow|Placebo 1st, Pioglitazone 2nd|"Placebo for first 8 weeks, then washout period for 4 weeks, and finally pioglitazone for 8 weeks.
Pioglitazone: 45 mg by mouth once a day for 8 weeks
Placebo: By mouth once a day for 8 weeks"
510553|NCT00763139|O4|Outcome|Placebo Phase After 8 Weeks|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
510554|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
510555|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.
510556|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
510557|NCT00763139|O4|Outcome|Placebo Phase wk After 8 Weeks|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks on medication are reported here.
512594|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
510558|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
510559|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks on medication are reported here.
510560|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
510561|NCT00763139|O4|Outcome|Placebo Phase wk 8/20|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
510562|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
510563|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks on medication are reported here.
510564|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
510565|NCT00763139|O4|Outcome|Placebo Phase wk 8/20|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
510566|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
510567|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.
510568|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
510569|NCT00763139|E2|Reported Event|Placebo|participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking placebo
510570|NCT00763139|E1|Reported Event|Pioglitazone|participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking pioglitazone
510571|NCT00763243|B1|Baseline|Cogmed Working Memory Training|"Cogmed Working Memory Training Program
Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
510572|NCT00763243|P1|Participant Flow|Cogmed Working Memory Training|"Cogmed Working Memory Training Program
Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
510573|NCT00763243|O5|Outcome|6-Month Follow Up Visit|Visit 6 months after Cogmed working memory training completed
510574|NCT00763243|O4|Outcome|1-Month Follow Up Visit|Visit 1 month after Cogmed working memory training was completed
510575|NCT00763243|O3|Outcome|Posttraining Visit|Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
510576|NCT00763243|O2|Outcome|Pretraining Visit|Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
510577|NCT00763243|O1|Outcome|Screening Visit|"Screening Visit at Study Entry
Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
510578|NCT00763243|O5|Outcome|6-Month Follow Up Visit|Visit 6 months after Cogmed working memory training completed
510579|NCT00763243|O4|Outcome|1-Month Follow Up Visit|Visit 1 month after Cogmed working memory training was completed
510580|NCT00763243|O3|Outcome|Posttraining Visit|Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
510581|NCT00763243|O2|Outcome|Pretraining Visit|Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
510582|NCT00763243|O1|Outcome|Screening Visit|"Screening Visit at Study Entry
Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
510583|NCT00763243|O5|Outcome|6-Month Follow Up Visit|Visit 6 months after Cogmed working memory training completed
510584|NCT00763243|O4|Outcome|1-Month Follow Up Visit|Visit 1 month after Cogmed working memory training was completed
510586|NCT00763243|O2|Outcome|Pretraining Visit|Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
510711|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510712|NCT00763412|E2|Reported Event|Repaglinide|Repaglinide intervention group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH).
510587|NCT00763243|O1|Outcome|Screening Visit|"Screening Visit at Study Entry
Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
510588|NCT00763243|E5|Reported Event|6-Month Follow Up Visit|Visit 6 months after Cogmed working memory training completed
510589|NCT00763243|E4|Reported Event|1-Month Follow Up Visit|Visit 1 month after Cogmed working memory training was completed
510590|NCT00763243|E3|Reported Event|Posttraining Visit|Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
510591|NCT00763243|E2|Reported Event|Pretraining Visit|Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
510592|NCT00763243|E1|Reported Event|Screening Visit|"Screening Visit at Study Entry
Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
510593|NCT00763256|B3|Baseline|Total|Total of all reporting groups
510594|NCT00763256|B2|Baseline|B - Placebo Comparator|fluoride only toothpaste
510595|NCT00763256|B1|Baseline|Active Comparator|triclosan/fluoride/copolymer toothpaste
510596|NCT00763256|P2|Participant Flow|B - Placebo Comparator|fluoride only toothpaste
510597|NCT00763256|P1|Participant Flow|Active Comparator|triclosan/fluoride/copolymer toothpaste
510598|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
510599|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
510600|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
510601|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
510602|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
510603|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
510604|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
510605|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
510606|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
510607|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
510608|NCT00763256|E2|Reported Event|B - Placebo Comparator|fluoride only toothpaste
510609|NCT00763256|E1|Reported Event|Active Comparator|triclosan/fluoride/copolymer toothpaste
510610|NCT00763269|B3|Baseline|Total|Total of all reporting groups
510611|NCT00763269|B2|Baseline|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
510612|NCT00763269|B1|Baseline|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
510613|NCT00763269|P2|Participant Flow|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
510614|NCT00763269|P1|Participant Flow|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
510615|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
510616|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
510617|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
510618|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
510619|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
510620|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
510621|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
510622|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
510623|NCT00763269|E2|Reported Event|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
510624|NCT00763269|E1|Reported Event|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
510625|NCT00763282|B3|Baseline|Total|Total of all reporting groups
510626|NCT00763282|B2|Baseline|Education (ED)|"Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
510627|NCT00763282|B1|Baseline|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
510710|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510713|NCT00763412|E1|Reported Event|Placebo|Placebo group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH).
510628|NCT00763282|P2|Participant Flow|Education (ED)|"Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
510629|NCT00763282|P1|Participant Flow|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
510630|NCT00763282|O2|Outcome|ED Group|"An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
510631|NCT00763282|O1|Outcome|SM+MI Group|Self Management (SM) + Motivational Interviewing (MI). Motivational Interviewing (MI) is an evidence-based form of counseling to improve behavior change. Self Management (SM) includes: 1) ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.
510632|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
510633|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
510634|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
510635|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
510636|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
510637|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
510638|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
510639|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
510789|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
512595|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
510640|NCT00763282|E2|Reported Event|Education (ED)|"Education (ED)
Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
510641|NCT00763282|E1|Reported Event|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
510642|NCT00763321|B4|Baseline|Total|Total of all reporting groups
510643|NCT00763321|B3|Baseline|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
510644|NCT00763321|B2|Baseline|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
510645|NCT00763321|B1|Baseline|Nonrandomized|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period.
510646|NCT00763321|P3|Participant Flow|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
510647|NCT00763321|P2|Participant Flow|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
510648|NCT00763321|P1|Participant Flow|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
510649|NCT00763321|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
510650|NCT00763321|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
510651|NCT00763321|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
510652|NCT00763321|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
510653|NCT00763321|E3|Reported Event|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
510654|NCT00763321|E2|Reported Event|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
510655|NCT00763321|E1|Reported Event|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
510656|NCT00763360|B4|Baseline|Total|Total of all reporting groups
510657|NCT00763360|B3|Baseline|Amvisc Plus|Amvisc Plus
510658|NCT00763360|B2|Baseline|Healon|Healon
510659|NCT00763360|B1|Baseline|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
510660|NCT00763360|P3|Participant Flow|Amvisc Plus|Amvisc Plus
510661|NCT00763360|P2|Participant Flow|Healon|Healon
510662|NCT00763360|P1|Participant Flow|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
510663|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
510664|NCT00763360|O2|Outcome|Healon|Healon
510665|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
510666|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
510667|NCT00763360|O2|Outcome|Healon|Healon
510668|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
510669|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
510670|NCT00763360|O2|Outcome|Healon|Healon
510671|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
510672|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
510673|NCT00763360|O2|Outcome|Healon|Healon
510674|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
510675|NCT00763360|E3|Reported Event|Amvisc Plus|Amvisc Plus
510676|NCT00763360|E2|Reported Event|Healon|Healon
510677|NCT00763360|E1|Reported Event|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
510678|NCT00763386|B3|Baseline|Total|Total of all reporting groups
510679|NCT00763386|B2|Baseline|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
510680|NCT00763386|B1|Baseline|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
510681|NCT00763386|P2|Participant Flow|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
510682|NCT00763386|P1|Participant Flow|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
510683|NCT00763386|O2|Outcome|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
510684|NCT00763386|O1|Outcome|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
510685|NCT00763386|O2|Outcome|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
510686|NCT00763386|O1|Outcome|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
510687|NCT00763386|E2|Reported Event|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
510688|NCT00763386|E1|Reported Event|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
510689|NCT00763412|B3|Baseline|Total|Total of all reporting groups
510753|NCT00763490|B1|Baseline|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
510690|NCT00763412|B2|Baseline|Patients Who Received Repaglinide|All participants were receiving ADEK vitamins and pancreatic enzyme replacement. Patients were required to be clinically stable, without evidence of deterioration from previous pulmonary function tests (PFTs) for 3-months prior to the study and without CF exacerbation or hospitalization for 2-months prior to the study. Additionally, patients were required to have maintained stable weight within 5% variance for 3-months prior to participation. Exclusion criteria included fasting blood glucose levels >126 mg/dL on study day, IV antibiotic or systemic steroid use within two months, oral corticosteroid usage for more than 28-days over the past 6-months, history of lung or liver transplant, elevated transaminases, allergic bronchopulmonary aspergillosis, or the inability to perform spirometry.
510691|NCT00763412|B1|Baseline|Patients Who Received Placebo|All participants were receiving ADEK vitamins and pancreatic enzyme replacement. Patients were required to be clinically stable, without evidence of deterioration from previous pulmonary function tests (PFTs) for 3-months prior to the study and without CF exacerbation or hospitalization for 2-months prior to the study. Additionally, patients were required to have maintained stable weight within 5% variance for 3-months prior to participation. Exclusion criteria included fasting blood glucose levels >126 mg/dL on study day, IV antibiotic or systemic steroid use within two months, oral corticosteroid usage for more than 28-days over the past 6-months, history of lung or liver transplant, elevated transaminases, allergic bronchopulmonary aspergillosis, or the inability to perform spirometry.
510692|NCT00763412|P2|Participant Flow|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510693|NCT00763412|P1|Participant Flow|Placebo|"1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510694|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510695|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510696|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510697|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510698|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510699|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510700|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510701|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510702|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510703|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510704|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510705|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510706|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510707|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510708|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
510709|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
512596|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
510715|NCT00763451|B4|Baseline|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
510716|NCT00763451|B3|Baseline|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
510717|NCT00763451|B2|Baseline|Placebo (One-step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
510718|NCT00763451|B1|Baseline|Placebo (Two-step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
510719|NCT00763451|P4|Participant Flow|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
510720|NCT00763451|P3|Participant Flow|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
510721|NCT00763451|P2|Participant Flow|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
510722|NCT00763451|P1|Participant Flow|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
510723|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
510724|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
510725|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
510726|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
510727|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
510728|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
510729|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
510730|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
510731|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
510732|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
510733|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
510734|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
510735|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
510736|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
510737|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
510738|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
510739|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
510740|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
510741|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
510742|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
510743|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
510744|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
510745|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
510746|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
510747|NCT00763451|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
510748|NCT00763451|E5|Reported Event|Lixisenatide One-step Titration|1-step initiation regimen of lixisenatide.
510749|NCT00763451|E4|Reported Event|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
510750|NCT00763451|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
510751|NCT00763451|E2|Reported Event|Placebo (One-step Titration)|1-step initiation regimen of volume matching placebo.
510752|NCT00763451|E1|Reported Event|Placebo (Two-step Titration)|2-step initiation regimen of volume matching placebo.
510787|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
510788|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
510754|NCT00763490|P1|Participant Flow|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
510755|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
510756|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
510757|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
510758|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
510759|NCT00763490|E1|Reported Event|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
510760|NCT00763698|B1|Baseline|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
510761|NCT00763698|P1|Participant Flow|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
510762|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Leads|Patients included in this analysis include the first 16 patients to provide LV lead bipolar pacing capture threshold data at 3 months with a pulse width of 0.5 ms.
510763|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
510764|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
510765|NCT00763698|E1|Reported Event|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
510766|NCT00763750|B1|Baseline|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36
PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
510767|NCT00763750|P1|Participant Flow|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36
PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
510768|NCT00763750|O1|Outcome|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36
PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
510769|NCT00763750|E1|Reported Event|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36
PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
510770|NCT00763815|B3|Baseline|Total|Total of all reporting groups
510771|NCT00763815|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg once daily QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
510772|NCT00763815|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
510773|NCT00763815|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
510774|NCT00763815|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
510775|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
510776|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
510777|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
510778|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
510779|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
510780|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
510781|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
510782|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
510783|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
510784|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
510785|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
510786|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
510790|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
510791|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
510792|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
510793|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
510794|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
510795|NCT00763815|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
510796|NCT00763815|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
510799|NCT00763867|B1|Baseline|Placebo|20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
510800|NCT00763867|P2|Participant Flow|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510801|NCT00763867|P1|Participant Flow|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510802|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510803|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510804|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510805|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510806|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510807|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510808|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510809|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510810|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510811|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510812|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510813|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510814|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510815|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510816|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510817|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510818|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510819|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510820|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510821|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510822|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510823|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510824|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510825|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510826|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510827|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510828|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510829|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510830|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510831|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510832|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510833|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510834|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510835|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510836|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510837|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510838|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510839|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510840|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510841|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510842|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510843|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510844|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510845|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510846|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510847|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510848|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510849|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510850|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510851|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510852|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510853|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510854|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510855|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510856|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510857|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510858|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510859|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510860|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510861|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510862|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510863|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510864|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510865|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510866|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510867|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510868|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510869|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510870|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510871|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510872|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510873|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510874|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510875|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510876|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510877|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510878|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510879|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510880|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510881|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510882|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510883|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510884|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510885|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510886|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510887|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510888|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510889|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510890|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510891|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510892|NCT00763867|E2|Reported Event|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510893|NCT00763867|E1|Reported Event|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
510894|NCT00763919|B1|Baseline|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510895|NCT00763919|P1|Participant Flow|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510896|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510897|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510898|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510899|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510900|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510901|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510937|NCT00763971|P3|Participant Flow|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
510902|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510903|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510904|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510905|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510906|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510907|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510908|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510909|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510910|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510911|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510912|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510913|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510914|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510915|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510916|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510917|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510918|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510919|NCT00763919|E1|Reported Event|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
510920|NCT00763958|B3|Baseline|Total|Total of all reporting groups
510921|NCT00763958|B2|Baseline|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
510922|NCT00763958|B1|Baseline|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
510923|NCT00763958|P2|Participant Flow|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
510924|NCT00763958|P1|Participant Flow|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
510925|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
510926|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of study drug based on clinical assessment.
510927|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
510928|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of stuty drug based on clinical assessment.
510929|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
510930|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of study drug based on clinical assessment.
510931|NCT00763958|E2|Reported Event|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
510932|NCT00763958|E1|Reported Event|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
510933|NCT00763971|B4|Baseline|Total|Total of all reporting groups
511001|NCT00755105|E1|Reported Event|Male Subjects Having Consumed Iron-55 Tracer|
510934|NCT00763971|B3|Baseline|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
510935|NCT00763971|B2|Baseline|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
510936|NCT00763971|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
510938|NCT00763971|P2|Participant Flow|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
510939|NCT00763971|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
510940|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
510941|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
510942|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
510943|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
510944|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
510945|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
510946|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
510947|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
510948|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
510949|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
510950|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
510951|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
510952|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
510953|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
510954|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
510955|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
510956|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
510957|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
510958|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
510959|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
510960|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
510961|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
510962|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
510963|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
511002|NCT00755131|B3|Baseline|Total|Total of all reporting groups
510964|NCT00763971|E3|Reported Event|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
510965|NCT00763971|E2|Reported Event|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
510966|NCT00763971|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
510967|NCT00755040|B3|Baseline|Total|Total of all reporting groups
510968|NCT00755040|B2|Baseline|Placebo|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.
placebo: Given as eye drops"
510969|NCT00755040|B1|Baseline|Ocular Cyclosporine (Restasis)|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.
cyclosporine ophthalmic emulsion: Given as eye drops"
510970|NCT00755040|P2|Participant Flow|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.
placebo: Given as eye drops"
510971|NCT00755040|P1|Participant Flow|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.
cyclosporine ophthalmic emulsion: Given as eye drops"
510972|NCT00755040|O2|Outcome|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.
placebo: Given as eye drops"
510973|NCT00755040|O1|Outcome|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.
cyclosporine ophthalmic emulsion: Given as eye drops"
510974|NCT00755040|O2|Outcome|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.
placebo: Given as eye drops"
510975|NCT00755040|O1|Outcome|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.
cyclosporine ophthalmic emulsion: Given as eye drops"
510976|NCT00755040|E2|Reported Event|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.
placebo: Given as eye drops"
510977|NCT00755040|E1|Reported Event|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.
cyclosporine ophthalmic emulsion: Given as eye drops"
510978|NCT00755079|B3|Baseline|Total|Total of all reporting groups
510979|NCT00755079|B2|Baseline|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
510980|NCT00755079|B1|Baseline|Placebo|"group of persons with spinal cord injury will receive blinded placebo capsule
placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
510981|NCT00755079|P2|Participant Flow|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
510982|NCT00755079|P1|Participant Flow|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule
placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
510983|NCT00755079|O2|Outcome|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
510984|NCT00755079|O1|Outcome|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule
placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
510985|NCT00755079|O2|Outcome|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
510986|NCT00755079|O1|Outcome|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule
placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
510987|NCT00755079|E2|Reported Event|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
510988|NCT00755079|E1|Reported Event|Placebo|"group of persons with spinal cord injury will receive blinded placebo capsule
placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
510989|NCT00755105|B4|Baseline|Total|Total of all reporting groups
510990|NCT00755105|B3|Baseline|Postmenopausal Women Having Consumed Iron-55 Tracer|
510991|NCT00755105|B2|Baseline|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
510992|NCT00755105|B1|Baseline|Male Subjects Having Consumed Iron-55 Tracer|
510993|NCT00755105|P3|Participant Flow|Postmenopausal Women Having Consumed Iron-55 Tracer|
510994|NCT00755105|P2|Participant Flow|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
510995|NCT00755105|P1|Participant Flow|Male Subjects Having Consumed Iron-55 Tracer|
510996|NCT00755105|O3|Outcome|Postmenopausal Women Having Consumed Iron-55 Tracer|
510997|NCT00755105|O2|Outcome|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
510998|NCT00755105|O1|Outcome|Male Subjects Having Consumed Iron-55 Tracer|
510999|NCT00755105|E3|Reported Event|Postmenopausal Women Having Consumed Iron-55 Tracer|
511000|NCT00755105|E2|Reported Event|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
511003|NCT00755131|B2|Baseline|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
511004|NCT00755131|B1|Baseline|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
511005|NCT00755131|P2|Participant Flow|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
511006|NCT00755131|P1|Participant Flow|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
511007|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
511008|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
511009|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
511010|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
511011|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
511012|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
511013|NCT00755131|E2|Reported Event|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
511014|NCT00755131|E1|Reported Event|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
511015|NCT00755196|B1|Baseline|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
511016|NCT00755196|P1|Participant Flow|AN2728 5 Percent (%) Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
511017|NCT00755196|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment­ targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
511018|NCT00755196|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
511019|NCT00755196|E1|Reported Event|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
511020|NCT00755222|B3|Baseline|Total|Total of all reporting groups
511021|NCT00755222|B2|Baseline|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511022|NCT00755222|B1|Baseline|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511023|NCT00755222|P2|Participant Flow|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511024|NCT00755222|P1|Participant Flow|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511025|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511026|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511027|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511028|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511029|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511053|NCT00755274|B2|Baseline|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
511030|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511031|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511032|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511033|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511034|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511035|NCT00755222|E2|Reported Event|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511036|NCT00755222|E1|Reported Event|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
511037|NCT00755235|B3|Baseline|Total|Total of all reporting groups
511038|NCT00755235|B2|Baseline|Usual Care|Participants will receive their usual care, with no additional education or care management services.
511039|NCT00755235|B1|Baseline|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
511040|NCT00755235|P2|Participant Flow|Usual Care|Participants will receive their usual care, with no additional education or care management services.
511041|NCT00755235|P1|Participant Flow|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
511042|NCT00755235|O2|Outcome|Usual Care|Participants will receive their usual care, with no additional education or care management services.
511043|NCT00755235|O1|Outcome|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
511044|NCT00755235|O2|Outcome|Usual Care|Participants will receive their usual care, with no additional education or care management services.
511045|NCT00755235|O1|Outcome|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
511046|NCT00755235|E2|Reported Event|Usual Care|Participants will receive their usual care, with no additional education or care management services.
511047|NCT00755235|E1|Reported Event|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
511048|NCT00755261|B1|Baseline|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.
Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.
Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
511049|NCT00755261|P1|Participant Flow|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.
Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.
Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
511050|NCT00755261|O1|Outcome|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.
Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.
Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
511051|NCT00755261|E1|Reported Event|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.
Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.
Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
511052|NCT00755274|B3|Baseline|Total|Total of all reporting groups
511086|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
511087|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
511054|NCT00755274|B1|Baseline|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
511055|NCT00755274|P2|Participant Flow|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
511095|NCT00755417|E2|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
511096|NCT00755417|E1|Reported Event|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
511056|NCT00755274|P1|Participant Flow|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
511057|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
511058|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
511059|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
511060|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
511061|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
511062|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
511063|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
511064|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
511065|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
511066|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
511067|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
511068|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
511069|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
511070|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
511071|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
511072|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
511073|NCT00755274|E2|Reported Event|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
511074|NCT00755274|E1|Reported Event|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
511075|NCT00755417|B4|Baseline|Total|Total of all reporting groups
511076|NCT00755417|B3|Baseline|Sugar Pill|Placebo 1200 mg or 1800 mg
511077|NCT00755417|B2|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
511078|NCT00755417|B1|Baseline|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
511079|NCT00755417|P3|Participant Flow|Sugar Pill|Placebo 1200 mg or 1800 mg
511080|NCT00755417|P2|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
511081|NCT00755417|P1|Participant Flow|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
511082|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
511083|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
511084|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
511085|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
511089|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
511090|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
511091|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
511092|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
511093|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
511094|NCT00755417|E3|Reported Event|Sugar Pill|Placebo 1200 mg or 1800 mg
511098|NCT00755716|B3|Baseline|Topiramate and Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
511099|NCT00755716|B2|Baseline|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
511100|NCT00755716|B1|Baseline|Placebo (Sugar Pill)|"Person receives an inactive placebo
Placebo (sugar pill): patients receive"
511101|NCT00755716|P3|Participant Flow|Topiramate and Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
511102|NCT00755716|P2|Participant Flow|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
511103|NCT00755716|P1|Participant Flow|Placebo (Sugar Pill)|"Person receives an inactive placebo
Placebo (sugar pill):"
511104|NCT00755716|O3|Outcome|Topiramate and Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
511105|NCT00755716|O2|Outcome|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
511106|NCT00755716|O1|Outcome|Placebo (Sugar Pill)|"Person receives an inactive placebo
Placebo (sugar pill): patients receive"
511107|NCT00755716|O3|Outcome|Topiramate and Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
511108|NCT00755716|O2|Outcome|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
511109|NCT00755716|O1|Outcome|Placebo (Sugar Pill)|"Person receives an inactive placebo
Placebo (sugar pill): patients receive"
511110|NCT00755716|E3|Reported Event|Topiramate & Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
511111|NCT00755716|E2|Reported Event|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
511112|NCT00755716|E1|Reported Event|Placebo (Sugar Pill)|"Person receives an inactive placebo
Placebo (sugar pill): patients receive"
511113|NCT00755755|B4|Baseline|Total|Total of all reporting groups
511114|NCT00755755|B3|Baseline|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511115|NCT00755755|B2|Baseline|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511116|NCT00755755|B1|Baseline|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511117|NCT00755755|P3|Participant Flow|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511118|NCT00755755|P2|Participant Flow|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511119|NCT00755755|P1|Participant Flow|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511120|NCT00755755|O3|Outcome|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511121|NCT00755755|O2|Outcome|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511122|NCT00755755|O1|Outcome|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511123|NCT00755755|O3|Outcome|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511124|NCT00755755|O2|Outcome|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511125|NCT00755755|O1|Outcome|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511532|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511126|NCT00755755|E3|Reported Event|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511127|NCT00755755|E2|Reported Event|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511128|NCT00755755|E1|Reported Event|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
511129|NCT00755807|B3|Baseline|Total|Total of all reporting groups
511130|NCT00755807|B2|Baseline|Placebo|Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511131|NCT00755807|B1|Baseline|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511132|NCT00755807|P2|Participant Flow|Placebo|Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511133|NCT00755807|P1|Participant Flow|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511134|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
511135|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
511136|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
511137|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511138|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511139|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511140|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511141|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
511142|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511143|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511144|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511145|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511146|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511147|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511148|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511149|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
511150|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511151|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511152|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511153|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511154|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511155|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511190|NCT00755807|E3|Reported Event|Duloxetine - Open-label Extension Phase|Participants previously receiving duloxetine or placebo in the double-blind acute phase received duloxetine 60, 90, or 120 mg QD for 12 weeks (open label extension phase)
511156|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511157|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511158|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511159|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511160|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511161|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511162|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511163|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511164|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511165|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511166|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511167|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511168|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511169|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511170|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
511171|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511172|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
511173|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511174|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
511175|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511176|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
511177|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511178|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
511179|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511180|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
511181|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511182|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
511183|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511184|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
511185|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511186|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
511187|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511188|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
511189|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
511191|NCT00755807|E2|Reported Event|Placebo - Double-Blind Acute Phase|Oral, QD for 6 weeks
511192|NCT00755807|E1|Reported Event|Duloxetine - Double-Blind Acute Phase|60 mg oral (po), once daily (QD) for 6 weeks (acute phase)
511193|NCT00755846|B7|Baseline|Total|Total of all reporting groups
511194|NCT00755846|B6|Baseline|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511195|NCT00755846|B5|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511196|NCT00755846|B4|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511197|NCT00755846|B3|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511536|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511198|NCT00755846|B2|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511199|NCT00755846|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511200|NCT00755846|P6|Participant Flow|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511201|NCT00755846|P5|Participant Flow|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511202|NCT00755846|P4|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511203|NCT00755846|P3|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511204|NCT00755846|P2|Participant Flow|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511205|NCT00755846|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511206|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511207|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511208|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511209|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511210|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511211|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511212|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511213|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511214|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511215|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511216|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511217|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511218|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511219|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511220|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511221|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511222|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511223|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511224|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511225|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511226|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511227|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511228|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511229|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511230|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511231|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511232|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511233|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511234|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511235|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511236|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511237|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511238|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511239|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511240|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511241|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511242|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511243|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511244|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511245|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511246|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511247|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511248|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511249|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511250|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511251|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511537|NCT00756548|O1|Outcome|BLI850|
511252|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511253|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511254|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511255|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511256|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511257|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511258|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511259|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511260|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511261|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511262|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511263|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511264|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511265|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511266|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511267|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511268|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511269|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511270|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511271|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511272|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511273|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511274|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511275|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511276|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511277|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511278|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511279|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511280|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511281|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511282|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511283|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511284|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511285|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511286|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511287|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511288|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511289|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511290|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511291|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511292|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511293|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511294|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511295|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511296|NCT00755846|E6|Reported Event|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
511297|NCT00755846|E5|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
511298|NCT00755846|E4|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
511299|NCT00755846|E3|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
511300|NCT00755846|E2|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
511527|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
511301|NCT00755846|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
511302|NCT00755911|B3|Baseline|Total|Total of all reporting groups
511303|NCT00755911|B2|Baseline|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
511304|NCT00755911|B1|Baseline|Treatment|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
511538|NCT00756548|E2|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|
511539|NCT00756548|E1|Reported Event|BLI850|
511305|NCT00755911|P2|Participant Flow|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
511306|NCT00755911|P1|Participant Flow|Treatment|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
511307|NCT00755911|O2|Outcome|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
511308|NCT00755911|O1|Outcome|Tissue Repair Cells (TRC)|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
511309|NCT00755911|O2|Outcome|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
511310|NCT00755911|O1|Outcome|Tissue Repair Cells (TRC)|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
511311|NCT00755911|E2|Reported Event|Sham Comparator: Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
511312|NCT00755911|E1|Reported Event|Experimental: Tissue Repair Cell (TRC)|Subjects will receive TRC therapy plus Gelfoam carrier
511313|NCT00755937|B1|Baseline|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
511314|NCT00755937|P1|Participant Flow|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
511315|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
511316|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
511317|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
511318|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
511319|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
511320|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
511321|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
511322|NCT00755937|E1|Reported Event|Subjects Receiving Remicade|
511323|NCT00756002|B3|Baseline|Total|Total of all reporting groups
511324|NCT00756002|B2|Baseline|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511325|NCT00756002|B1|Baseline|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511326|NCT00756002|P2|Participant Flow|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511327|NCT00756002|P1|Participant Flow|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511328|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511329|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511330|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511331|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511332|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511333|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511334|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511335|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511336|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511337|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511338|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511339|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511340|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511341|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511528|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
511342|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511343|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511344|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511345|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511346|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511347|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511348|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511349|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511350|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511351|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511352|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511353|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511354|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511355|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511356|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511357|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511358|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511359|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511360|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511361|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511362|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511363|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511364|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511365|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511366|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511367|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511368|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511369|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511370|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511371|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511372|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511373|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511374|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511375|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511376|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511377|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511378|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511379|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511380|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511381|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511382|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511383|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511384|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511385|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511386|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511387|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511388|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511389|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511390|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511391|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511392|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511393|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511394|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511395|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511396|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511397|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511398|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511399|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511400|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511401|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511402|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511403|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511404|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511405|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511406|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511407|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511408|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511409|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511410|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511411|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511412|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511413|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511414|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511415|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511416|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511417|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511418|NCT00756002|E2|Reported Event|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
511419|NCT00756002|E1|Reported Event|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
511420|NCT00756093|B1|Baseline|Overall Study|
511421|NCT00756093|P4|Participant Flow|GenTeal Moderate, Then Systane, Then Optive, Then Blink Tears|Patients received GenTeal Moderate first, then Systane, then Optive, then Blink Tears last
511422|NCT00756093|P3|Participant Flow|Blink Tears, Then GenTeal Moderate, Then Systane, Then Optive|Patients received Blink Tears first, then GenTeal Moderate, then Systane, then Optive last
511423|NCT00756093|P2|Participant Flow|Optive, Then Blink Tears, Then GenTeal Moderate, Then Systane|Patients received Optive first, then Blink Tears, then GenTeal Moderate, then Systane
511424|NCT00756093|P1|Participant Flow|Systane, Then Optive, Then Blink Tears, Then GenTeal Moderate|Pateints received Systane first, then Optive, then Blink Tears, then GenTeal Moderate last.
511425|NCT00756093|O4|Outcome|GenTeal Moderate Lubricant Eye Drops|GenTeal Moderate Lubricant Eye Drops
511426|NCT00756093|O3|Outcome|Blink Tears|Blink Tears
511427|NCT00756093|O2|Outcome|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops
511428|NCT00756093|O1|Outcome|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops
511429|NCT00756093|E4|Reported Event|GenTeal Moderate Lubricant Eye Drops|GenTeal Moderate Lubricant Eye Drops
511430|NCT00756093|E3|Reported Event|Blink Tears|Blink Tears
511431|NCT00756093|E2|Reported Event|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops
511432|NCT00756093|E1|Reported Event|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops
511433|NCT00756236|B4|Baseline|Total|Total of all reporting groups
511434|NCT00756236|B3|Baseline|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.
P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
511435|NCT00756236|B2|Baseline|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.
Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
511436|NCT00756236|B1|Baseline|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.
Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
511437|NCT00756236|P3|Participant Flow|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.
P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
511438|NCT00756236|P2|Participant Flow|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.
Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
511439|NCT00756236|P1|Participant Flow|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.
Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
511440|NCT00756236|O3|Outcome|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.
P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
511441|NCT00756236|O2|Outcome|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.
Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
511442|NCT00756236|O1|Outcome|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.
Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
511443|NCT00756236|E3|Reported Event|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.
P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
511444|NCT00756236|E2|Reported Event|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.
Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
511533|NCT00756548|O1|Outcome|BLI850|
511445|NCT00756236|E1|Reported Event|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.
Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
511446|NCT00756314|B3|Baseline|Total|Total of all reporting groups
511447|NCT00756314|B2|Baseline|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
511448|NCT00756314|B1|Baseline|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
511449|NCT00756314|P2|Participant Flow|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
511450|NCT00756314|P1|Participant Flow|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
511451|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
511452|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
511453|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
511454|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
511455|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
511456|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
511457|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
511458|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
511459|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
511460|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
511461|NCT00756314|E2|Reported Event|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
511462|NCT00756314|E1|Reported Event|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
511463|NCT00756444|B3|Baseline|Total|Total of all reporting groups
511464|NCT00756444|B2|Baseline|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
511465|NCT00756444|B1|Baseline|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
511466|NCT00756444|P2|Participant Flow|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
511467|NCT00756444|P1|Participant Flow|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
511468|NCT00756444|O2|Outcome|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
511469|NCT00756444|O1|Outcome|Panitumuab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
511529|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
511470|NCT00756444|O2|Outcome|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
511540|NCT00756561|B1|Baseline|Healthy Normal Males|Men, 18-50 years of age, in good health
511471|NCT00756444|O1|Outcome|Panitumuab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
511472|NCT00756444|E3|Reported Event|Total|
511473|NCT00756444|E2|Reported Event|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
511474|NCT00756444|E1|Reported Event|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
511475|NCT00756457|B3|Baseline|Total|Total of all reporting groups
511476|NCT00756457|B2|Baseline|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
511477|NCT00756457|B1|Baseline|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
511478|NCT00756457|P2|Participant Flow|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
511479|NCT00756457|P1|Participant Flow|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
511480|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
511481|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
511482|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
511483|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
511484|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
511485|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
511486|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
511487|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
511488|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
511489|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
511490|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
511491|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
511492|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
511493|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
511494|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
511495|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
511530|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
511531|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
511496|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
511497|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
511498|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
511499|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
511500|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
511501|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
511502|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
511503|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
511504|NCT00756457|E2|Reported Event|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
511505|NCT00756457|E1|Reported Event|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
511506|NCT00756470|B1|Baseline|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
511507|NCT00756470|P1|Participant Flow|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil (5FU), Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
511508|NCT00756470|O1|Outcome|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
511509|NCT00756470|O1|Outcome|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
511510|NCT00756470|E1|Reported Event|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
511511|NCT00756548|B3|Baseline|Total|Total of all reporting groups
511512|NCT00756548|B2|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|
511513|NCT00756548|B1|Baseline|BLI850|
511514|NCT00756548|P2|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|single administration oral preparation - split dose
511515|NCT00756548|P1|Participant Flow|BLI850|single administration oral preparation - split dose
511516|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
511517|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
511518|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
511519|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
511520|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
511521|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
511522|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
511523|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
511524|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
511525|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
511526|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
511625|NCT00756938|E8|Reported Event|Extension-Losartan 1.4 mg/kg/Day|
511534|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
511535|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
511541|NCT00756561|P1|Participant Flow|Healthy Normal Males|Men, 18-50 years of age, in good health
511542|NCT00756561|O2|Outcome|Serum Concentration|Serum hormone concentration in 10 normal men
511543|NCT00756561|O1|Outcome|Intratesticular Concentration|Average intratesticular hormone concentration between right and left testis in 10 normal men
511544|NCT00756561|E1|Reported Event|Healthy Normal Males|Men, 18-50 years of age, in good health
511545|NCT00756574|B3|Baseline|Total|Total of all reporting groups
511546|NCT00756574|B2|Baseline|2. N95 Respirator|N95 respirator
511547|NCT00756574|B1|Baseline|1. Surgical|surgical mask
511548|NCT00756574|P2|Participant Flow|2. N95 Respirator|N95 respirator
511549|NCT00756574|P1|Participant Flow|1. Surgical|surgical mask
511550|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
511551|NCT00756574|O1|Outcome|1. Surgical|surgical mask
511552|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
511553|NCT00756574|O1|Outcome|1. Surgical|surgical mask
511554|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
511555|NCT00756574|O1|Outcome|1. Surgical|surgical mask
511556|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
511557|NCT00756574|O1|Outcome|1. Surgical|surgical mask
511558|NCT00756678|B1|Baseline|All Patients|All patients
511559|NCT00756678|P1|Participant Flow|All Patients|All patients
511560|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
511561|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
511562|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
511563|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
511564|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
511565|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
511566|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
511567|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
511568|NCT00756678|E1|Reported Event|All Patients|All patients
511569|NCT00756730|B3|Baseline|Total|Total of all reporting groups
511570|NCT00756730|B2|Baseline|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
511571|NCT00756730|B1|Baseline|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
511572|NCT00756730|P2|Participant Flow|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
511573|NCT00756730|P1|Participant Flow|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
511574|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
511575|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
511576|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
511577|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
511578|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
511579|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
511580|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
511581|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
511582|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
511583|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
511584|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
511626|NCT00756938|E7|Reported Event|Extension-Losartan 0.7 mg/kg/Day|
511627|NCT00756938|E6|Reported Event|Extension-Losartan 0.3 mg/kg/Day|
511585|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
511586|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
511587|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
511588|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
511589|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
511590|NCT00756730|E2|Reported Event|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
511591|NCT00756730|E1|Reported Event|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
511592|NCT00756886|B3|Baseline|Total|Total of all reporting groups
511593|NCT00756886|B2|Baseline|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
511594|NCT00756886|B1|Baseline|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
511595|NCT00756886|P2|Participant Flow|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
511596|NCT00756886|P1|Participant Flow|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
511597|NCT00756886|O2|Outcome|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
511598|NCT00756886|O1|Outcome|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
511599|NCT00756886|E2|Reported Event|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
511600|NCT00756886|E1|Reported Event|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
511601|NCT00756938|B4|Baseline|Total|Total of all reporting groups
511602|NCT00756938|B3|Baseline|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
511603|NCT00756938|B2|Baseline|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
511604|NCT00756938|B1|Baseline|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
511605|NCT00756938|P4|Participant Flow|Losartan Potassium-Extension|Participants who elected to enter extension; dose level of Losartan was that which was being administered at end of base study
511606|NCT00756938|P3|Participant Flow|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
511607|NCT00756938|P2|Participant Flow|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
511608|NCT00756938|P1|Participant Flow|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
511609|NCT00756938|O5|Outcome|Extension-Losartan Potassium|Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
511610|NCT00756938|O4|Outcome|Base Study-Losartan Potassium 1.4 mg/kg|Open-label losartan 1.4 mg/kg/day
511611|NCT00756938|O3|Outcome|Base Study-Losartan Potassium 0.7 mg/kg|Open-label Losartan 0.7 mg/kg/day
511612|NCT00756938|O2|Outcome|Base Study-Losartan Potassium 0.3 mg/kg|Open-label Losartan 0.3 mg/kg/day
511613|NCT00756938|O1|Outcome|Base Study-Losartan Potassium 0.1 mg/kg|Open-label Losartan 0.1 mg/kg/day
511614|NCT00756938|O5|Outcome|Extension-Losartan Potassium|Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
511615|NCT00756938|O4|Outcome|Base Study-Losartan Potassium 1.4 mg/kg|Open-label losartan 1.4 mg/kg/day
511616|NCT00756938|O3|Outcome|Base Study-Losartan Potassium 0.7 mg/kg|Open-label Losartan 0.7 mg/kg/day
511617|NCT00756938|O2|Outcome|Base Study-Losartan Potassium 0.3 mg/kg|Open-label Losartan 0.3 mg/kg/day
511618|NCT00756938|O1|Outcome|Base Study-Losartan Potassium 0.1 mg/kg|Open-label Losartan 0.1 mg/kg/day
511619|NCT00756938|O3|Outcome|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
511620|NCT00756938|O2|Outcome|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
511621|NCT00756938|O1|Outcome|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
511622|NCT00756938|O3|Outcome|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
511623|NCT00756938|O2|Outcome|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
511624|NCT00756938|O1|Outcome|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
511630|NCT00756938|E3|Reported Event|Base Study-Losartan Potassium 0.7 mg/kg/Day|
511631|NCT00756938|E2|Reported Event|Base Study-Losartan Potassium 0.3 mg/kg/Day|
511632|NCT00756938|E1|Reported Event|Base Study-Losartan Potassium 0.1 mg/kg/Day|
511633|NCT00756964|B3|Baseline|Total|Total of all reporting groups
511634|NCT00756964|B2|Baseline|Placebo Group|This group received an identical placebo of rasburicase.
511635|NCT00756964|B1|Baseline|Rasburicase Group|The drug rasburicase was used in this group.
511636|NCT00756964|P2|Participant Flow|Placebo Group|This group received an identical placebo of rasburicase.
511637|NCT00756964|P1|Participant Flow|Rasburicase Group|The drug rasburicase was used in this group.
511638|NCT00756964|O2|Outcome|Placebo Group|The patients which received a placebo identical to rasburicase.
511639|NCT00756964|O1|Outcome|Rasburicase Group|The patients received the drug rasburicase 7.5mg in 50mL of normal saline over 30 minutes period
511640|NCT00756964|E2|Reported Event|Placebo Group|This group received an identical placebo of rasburicase.
511641|NCT00756964|E1|Reported Event|Rasburicase Group|The drug rasburicase was used in this group.
511642|NCT00756977|B3|Baseline|Total|Total of all reporting groups
511643|NCT00756977|B2|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|
511644|NCT00756977|B1|Baseline|BLI850|
511645|NCT00756977|P2|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|Single administration oral preparation
511646|NCT00756977|P1|Participant Flow|BLI850|Single administration oral preparation
511647|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511648|NCT00756977|O1|Outcome|BLI850|
511649|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511650|NCT00756977|O1|Outcome|BLI850|
511651|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511652|NCT00756977|O1|Outcome|BLI850|
511653|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511654|NCT00756977|O1|Outcome|BLI850|
511655|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511656|NCT00756977|O1|Outcome|BLI850|
511657|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511658|NCT00756977|O1|Outcome|BLI850|
511659|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511660|NCT00756977|O1|Outcome|BLI850|
511661|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511662|NCT00756977|O1|Outcome|BLI850|
511663|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511664|NCT00756977|O1|Outcome|BLI850|
511665|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511666|NCT00756977|O1|Outcome|BLI850|
511667|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
511668|NCT00756977|O1|Outcome|BLI850|
511669|NCT00756977|E2|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|
511670|NCT00756977|E1|Reported Event|BLI850|
511671|NCT00757003|B1|Baseline|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
511672|NCT00757003|P1|Participant Flow|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
511673|NCT00757003|O1|Outcome|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
511674|NCT00757003|O1|Outcome|Treatment Arm - Placement of TAG Device|"A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta
Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta"
511675|NCT00757003|O1|Outcome|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
511676|NCT00757003|E1|Reported Event|Treatment Arm - Placement of TAG Device|"A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta
Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta"
511677|NCT00757172|B1|Baseline|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
511678|NCT00757172|P1|Participant Flow|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
511679|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
511680|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
511736|NCT00764322|O3|Outcome|Intermediate Metabolizers|Those with reduced transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
512597|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
511681|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
511682|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
511745|NCT00764361|P2|Participant Flow|Placebo|placebo gel
511683|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
511684|NCT00757172|E1|Reported Event|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
511685|NCT00757237|B3|Baseline|Total|Total of all reporting groups
511686|NCT00757237|B2|Baseline|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511687|NCT00757237|B1|Baseline|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511688|NCT00757237|P2|Participant Flow|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511689|NCT00757237|P1|Participant Flow|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511690|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511691|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511692|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511693|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511694|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511695|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511696|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511697|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511698|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511699|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511700|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511701|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511702|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511703|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511704|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511705|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511706|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511737|NCT00764322|O2|Outcome|Extensive Metabolizers|Those with the most normal transformation of the CYP2D6 genotype to allelic activity
511738|NCT00764322|O1|Outcome|Ultra-rapid Metabolizers|Those with the highest transformation of the CYP2D6 genotype to allelic activity
511707|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511708|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511746|NCT00764361|P1|Participant Flow|NanoDOX™ Hydrogel|1.0% doxycycline gel
511709|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511710|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511711|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511712|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511713|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511714|NCT00757237|E2|Reported Event|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
511715|NCT00757237|E1|Reported Event|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
511716|NCT00764309|B1|Baseline|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
511717|NCT00764309|P1|Participant Flow|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
511718|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
511719|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
511720|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
511721|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
511722|NCT00764309|E1|Reported Event|Dasatinib|
511723|NCT00764322|B3|Baseline|Total|Total of all reporting groups
511724|NCT00764322|B2|Baseline|Intermediate and Poor Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
511725|NCT00764322|B1|Baseline|Extensive and Ultra-rapid Metabolizers|Those with the highest endoxifen concentrations as measured at baseline.
511726|NCT00764322|P1|Participant Flow|Patients Enrolled|
511727|NCT00764322|O1|Outcome|All Participants|All participants in the main study who consented to this additional survey
511728|NCT00764322|O1|Outcome|Poor Metabolizers|Those with no transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
511729|NCT00764322|O1|Outcome|African Americans|Participants who self identified as African American Race
511730|NCT00764322|O3|Outcome|Poor Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
511731|NCT00764322|O2|Outcome|Intermediate Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
511732|NCT00764322|O1|Outcome|Extensive Metabolizers|Those with the highest endoxifen concentrations as measured at baseline.
511733|NCT00764322|O2|Outcome|Tamoxifen 40|"This arm, containing the intermediate and poor metabolizer genotypes, receives escalated treatment with tamoxifen at 40mg.
tamoxifen citrate: Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.
gene expression analysis: Genetic analysis of blood sample.
pharmacogenomic studies: Genetic analysis of blood sample.
questionnaire administration: Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months
quality-of-life assessment: Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months."
511734|NCT00764322|O1|Outcome|Tamoxifen 20|"One arm, containing the ultra-rapid and extensive metabolizer genotypes, continues treatment with tamoxifen at 20mg.
tamoxifen citrate: Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.
gene expression analysis: Genetic analysis of blood sample.
pharmacogenomic studies: Genetic analysis of blood sample.
questionnaire administration: Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months
quality-of-life assessment: Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months."
511735|NCT00764322|O4|Outcome|Poor Metabolizers|Those with no transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
511739|NCT00764322|E3|Reported Event|Poor Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
511740|NCT00764322|E2|Reported Event|Intermediate Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
511741|NCT00764322|E1|Reported Event|Ultra-rapid and Extensive Metabolizers|Those with the highest endoxifen concentrations as measured at baseline.
511742|NCT00764361|B3|Baseline|Total|Total of all reporting groups
511743|NCT00764361|B2|Baseline|Placebo|placebo gel
511744|NCT00764361|B1|Baseline|NanoDOX™ Hydrogel|1.0% doxycycline gel
511748|NCT00764361|O1|Outcome|NanoDOX™ Hydrogel|1.0% doxycycline monohydrate gel
511749|NCT00764361|E2|Reported Event|Placebo|placebo gel
511750|NCT00764361|E1|Reported Event|NanoDOX™ Hydrogel|1.0% doxycycline gel
511751|NCT00764465|B7|Baseline|Total|Total of all reporting groups
511752|NCT00764465|B6|Baseline|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
511753|NCT00764465|B5|Baseline|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
511754|NCT00764465|B4|Baseline|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
511755|NCT00764465|B3|Baseline|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
511756|NCT00764465|B2|Baseline|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
511757|NCT00764465|B1|Baseline|Group A|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
511758|NCT00764465|P6|Participant Flow|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
511759|NCT00764465|P5|Participant Flow|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
511760|NCT00764465|P4|Participant Flow|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
511761|NCT00764465|P3|Participant Flow|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
511762|NCT00764465|P2|Participant Flow|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
511763|NCT00764465|P1|Participant Flow|Group A|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
511764|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
511765|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
511766|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
511767|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
511768|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
511769|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
511770|NCT00764465|O6|Outcome|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
511771|NCT00764465|O5|Outcome|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
511772|NCT00764465|O4|Outcome|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
511773|NCT00764465|O3|Outcome|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
511774|NCT00764465|O2|Outcome|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
511775|NCT00764465|O1|Outcome|Group A|Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
511776|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
511818|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511777|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
511778|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
511823|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511779|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
511780|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
511781|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
511782|NCT00764465|E6|Reported Event|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
511783|NCT00764465|E5|Reported Event|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
511784|NCT00764465|E4|Reported Event|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
511785|NCT00764465|E3|Reported Event|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
511786|NCT00764465|E2|Reported Event|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
511787|NCT00764465|E1|Reported Event|Group A|Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
511788|NCT00764478|B4|Baseline|Total|Total of all reporting groups
511789|NCT00764478|B3|Baseline|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511790|NCT00764478|B2|Baseline|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511791|NCT00764478|B1|Baseline|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511792|NCT00764478|P3|Participant Flow|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511793|NCT00764478|P2|Participant Flow|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511794|NCT00764478|P1|Participant Flow|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually twice daily (BID) for 21 days
511795|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511796|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511797|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511798|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511799|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511800|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511801|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511802|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511803|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511804|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511805|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511806|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511807|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511808|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511809|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511810|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511811|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511812|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511813|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511814|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511815|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511816|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511817|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511819|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511820|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511821|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511822|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511824|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511825|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511826|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511827|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511828|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511829|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511830|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511831|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511832|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511833|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511834|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511835|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511836|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511837|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511838|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511839|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511840|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511841|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511842|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511843|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511844|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511845|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511846|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511847|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511848|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511849|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511850|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511851|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511852|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511853|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511854|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511855|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511856|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511857|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511858|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511859|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511860|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511861|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511862|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511863|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511864|NCT00764478|E3|Reported Event|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
511865|NCT00764478|E2|Reported Event|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
511866|NCT00764478|E1|Reported Event|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
511867|NCT00764504|B4|Baseline|Total|Total of all reporting groups
511943|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
511868|NCT00764504|B3|Baseline|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
511869|NCT00764504|B2|Baseline|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
512608|NCT00769119|E2|Reported Event|Placebo|Placebo, 2 tablets twice daily (bid)
511870|NCT00764504|B1|Baseline|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
511871|NCT00764504|P3|Participant Flow|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
511872|NCT00764504|P2|Participant Flow|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
511873|NCT00764504|P1|Participant Flow|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
511874|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
511875|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
511876|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
511877|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
511878|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
511879|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
511880|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
511881|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
511882|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
511883|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
511884|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
511885|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
511886|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
511887|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
511888|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
511889|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
511890|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
511891|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
511892|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
511893|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
512598|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
511894|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
511895|NCT00764504|E3|Reported Event|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
511896|NCT00764504|E2|Reported Event|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
511897|NCT00764504|E1|Reported Event|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
511898|NCT00767000|B6|Baseline|Total|Total of all reporting groups
511899|NCT00767000|B5|Baseline|Placebo|Placebo three times daily plus insulin once daily with or without metformin
511900|NCT00767000|B4|Baseline|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
511901|NCT00767000|B3|Baseline|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
511902|NCT00767000|B2|Baseline|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
511903|NCT00767000|B1|Baseline|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
511904|NCT00767000|P5|Participant Flow|Placebo|Placebo three times daily plus insulin once daily with or without metformin
511905|NCT00767000|P4|Participant Flow|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
511906|NCT00767000|P3|Participant Flow|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
511907|NCT00767000|P2|Participant Flow|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
511908|NCT00767000|P1|Participant Flow|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
511909|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
511910|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
511911|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
511912|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
511913|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
511914|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
511915|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
511916|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
511917|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
511918|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
511919|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
511920|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
511921|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
511922|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
511923|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
511924|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
511925|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
511926|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
511927|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
511928|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
511929|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
511930|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
511931|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
511932|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
511933|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
511934|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
511935|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
511936|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
511937|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
511938|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
511939|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
511940|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
511941|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
511942|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
512318|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
511944|NCT00767000|E5|Reported Event|Placebo|Placebo three times daily plus insulin once daily with or without metformin
511945|NCT00767000|E4|Reported Event|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
511946|NCT00767000|E3|Reported Event|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
512609|NCT00769119|E1|Reported Event|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
511947|NCT00767000|E2|Reported Event|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
511948|NCT00767000|E1|Reported Event|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
511949|NCT00767039|B3|Baseline|Total|Total of all reporting groups
511950|NCT00767039|B2|Baseline|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511951|NCT00767039|B1|Baseline|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511952|NCT00767039|P2|Participant Flow|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511953|NCT00767039|P1|Participant Flow|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511954|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511955|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511956|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511957|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511958|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511959|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511960|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511961|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511962|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511963|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511964|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511965|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511966|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511967|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511968|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511969|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511970|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511971|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511972|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511973|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511974|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
512599|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
511975|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
512072|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
511976|NCT00767039|E2|Reported Event|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
511977|NCT00767039|E1|Reported Event|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
511978|NCT00767104|B3|Baseline|Total|Total of all reporting groups
511979|NCT00767104|B2|Baseline|Control Pillowcase|placebo pillowcase made of 100% cotton
511980|NCT00767104|B1|Baseline|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
511981|NCT00767104|P2|Participant Flow|Control Pillowcase|placebo pillowcase made of 100% cotton
511982|NCT00767104|P1|Participant Flow|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
511983|NCT00767104|O2|Outcome|Control Pillowcase|placebo pillowcase made of 100% cotton
511984|NCT00767104|O1|Outcome|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
511985|NCT00767104|O2|Outcome|Control Cotton Pillowcase|placebo pillowcase made of 100% cotton
511986|NCT00767104|O1|Outcome|Experimental Silk-like Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
511987|NCT00767104|E2|Reported Event|Control Pillowcase|placebo pillowcase made of 100% cotton
511988|NCT00767104|E1|Reported Event|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
511989|NCT00767325|B1|Baseline|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
511990|NCT00767325|P1|Participant Flow|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
511991|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
511992|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
511993|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
511994|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
511995|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
511996|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
511997|NCT00767325|E1|Reported Event|Aba 10 mg/kg|
511998|NCT00767338|B5|Baseline|Total|Total of all reporting groups
511999|NCT00767338|B4|Baseline|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
512000|NCT00767338|B3|Baseline|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
512001|NCT00767338|B2|Baseline|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
512600|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512002|NCT00767338|B1|Baseline|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
512003|NCT00767338|P4|Participant Flow|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
512004|NCT00767338|P3|Participant Flow|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
512005|NCT00767338|P2|Participant Flow|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
512006|NCT00767338|P1|Participant Flow|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
512007|NCT00767338|O4|Outcome|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
512008|NCT00767338|O3|Outcome|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
512009|NCT00767338|O2|Outcome|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
512010|NCT00767338|O1|Outcome|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
512011|NCT00767338|E4|Reported Event|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
512012|NCT00767338|E3|Reported Event|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
512013|NCT00767338|E2|Reported Event|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
512014|NCT00767338|E1|Reported Event|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
512015|NCT00767364|B3|Baseline|Total|Total of all reporting groups
512016|NCT00767364|B2|Baseline|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
512017|NCT00767364|B1|Baseline|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
512018|NCT00767364|P2|Participant Flow|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
512019|NCT00767364|P1|Participant Flow|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
512020|NCT00767364|O2|Outcome|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
512021|NCT00767364|O1|Outcome|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
512022|NCT00767364|O2|Outcome|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
512023|NCT00767364|O1|Outcome|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
512024|NCT00767364|E2|Reported Event|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
512025|NCT00767364|E1|Reported Event|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
512026|NCT00767455|B1|Baseline|HP828-101 vs. Negative Control vs. Positive Control|each subject was their own control and received patches of all (test article, negative control, and positive control)
512027|NCT00767455|P1|Participant Flow|HP828-101 vs. Negative Control vs. Positive Control|Each subject was their own control and received patches containing approximately 200 mg of all three (test article, negative control, and positive control)
512028|NCT00767455|O3|Outcome|Positive Control|Sodium Lauryl Sulfate
512029|NCT00767455|O2|Outcome|Negative Control|Johnson's Baby Oil
512030|NCT00767455|O1|Outcome|HP828-101|Intervention test article
512031|NCT00767455|E1|Reported Event|HP828-101 vs. Negative Control vs. Positive Control|each subject was their own control and received patches of all (test article, negative control, and positive control)
512032|NCT00767507|B5|Baseline|Total|Total of all reporting groups
512033|NCT00767507|B4|Baseline|Stage II Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512034|NCT00767507|B3|Baseline|Stage II Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512601|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512035|NCT00767507|B2|Baseline|Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512036|NCT00767507|B1|Baseline|Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512037|NCT00767507|P4|Participant Flow|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512038|NCT00767507|P3|Participant Flow|Stage II - Cangrelor Arm (0.75 mcg/kg/Min )|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512039|NCT00767507|P2|Participant Flow|Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512040|NCT00767507|P1|Participant Flow|Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512041|NCT00767507|O4|Outcome|Stage I - Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512042|NCT00767507|O3|Outcome|Stage I, Cohort 1 - Cangrelor (0.5 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512043|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512044|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512045|NCT00767507|O4|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512046|NCT00767507|O3|Outcome|Stage I, Cohort 1 - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512047|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512048|NCT00767507|O1|Outcome|Stage II - Cangrelor (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512049|NCT00767507|O4|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512050|NCT00767507|O3|Outcome|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512051|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512052|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512053|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512054|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512055|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received m as a matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512056|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512057|NCT00767507|O2|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512058|NCT00767507|O1|Outcome|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512059|NCT00767507|E4|Reported Event|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512060|NCT00767507|E3|Reported Event|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512061|NCT00767507|E2|Reported Event|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512062|NCT00767507|E1|Reported Event|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
512063|NCT00767520|B3|Baseline|Total|Total of all reporting groups
512064|NCT00767520|B2|Baseline|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
512065|NCT00767520|B1|Baseline|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512066|NCT00767520|P2|Participant Flow|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
512067|NCT00767520|P1|Participant Flow|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512068|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
512069|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512070|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
512071|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512610|NCT00769132|B1|Baseline|Totals for Study|All participants in the study.
512073|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512074|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
512075|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512076|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
512077|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512078|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
512079|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512080|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
512081|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512082|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
512083|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512084|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
512085|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512086|NCT00767520|E2|Reported Event|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
512087|NCT00767520|E1|Reported Event|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
512088|NCT00767572|B1|Baseline|Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin|Patients were randomly assigned to receive atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment were performed before and after each 12 week intervention.
512089|NCT00767572|P1|Participant Flow|Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin|Patients were randomized to atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment was performed before and after each 12 week intervention.
512090|NCT00767572|O2|Outcome|Sugar Pill|See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
512091|NCT00767572|O1|Outcome|Atorvastatin|Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks.
512092|NCT00767572|E2|Reported Event|Sugar Pill|See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
512093|NCT00767572|E1|Reported Event|Atorvastatin|Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks. Brachial artery assessment will be performed before and after each 12 week period on therapy.
512094|NCT00767624|B3|Baseline|Total|Total of all reporting groups
512095|NCT00767624|B2|Baseline|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Cognitive Behavioral Therapy for Insomnia"
512096|NCT00767624|B1|Baseline|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Desensitization Therapy for Insomnia"
512097|NCT00767624|P2|Participant Flow|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Cognitive Behavioral Therapy for Insomnia"
512098|NCT00767624|P1|Participant Flow|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Desensitization Therapy for Insomnia"
512099|NCT00767624|O2|Outcome|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Cognitive Behavioral Therapy for Insomnia"
512100|NCT00767624|O1|Outcome|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Desensitization Therapy for Insomnia"
512101|NCT00767624|O2|Outcome|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Cognitive Behavioral Therapy for Insomnia"
512102|NCT00767624|O1|Outcome|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Desensitization Therapy for Insomnia"
512103|NCT00767624|E2|Reported Event|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Cognitive Behavioral Therapy for Insomnia"
512104|NCT00767624|E1|Reported Event|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Desensitization Therapy for Insomnia"
512105|NCT00767676|B1|Baseline|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
512106|NCT00767676|P1|Participant Flow|HP828-101|HP828-101 : Nine topical patch applications, each the approximate size of a nickel, over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
512107|NCT00767676|O1|Outcome|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
512108|NCT00767676|E1|Reported Event|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
512109|NCT00767767|B6|Baseline|Total|Total of all reporting groups
512110|NCT00767767|B5|Baseline|Thiopental 3mcg/mL|"Anesthetic Drug Infusion
Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
512111|NCT00767767|B4|Baseline|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion
Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
512112|NCT00767767|B3|Baseline|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion
Propofol 0.9mcg/mL: IV Propfol infusion for 2 hours."
512113|NCT00767767|B2|Baseline|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion
Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
512114|NCT00767767|B1|Baseline|Placebos|"Saline Infusion
Placebos: IV Saline infusion for 2 hours."
512115|NCT00767767|P5|Participant Flow|Thiopental 3mcg/mL|"Anesthetic Drug Infusion
Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
512116|NCT00767767|P4|Participant Flow|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion
Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
512117|NCT00767767|P3|Participant Flow|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion
Propofol 0.9mcg/mL: IV Propofol infusion for 2 hours."
512118|NCT00767767|P2|Participant Flow|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion
Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
512119|NCT00767767|P1|Participant Flow|Placebos|"Saline Infusion
Placebos: IV Saline infusion for 2 hours."
512120|NCT00767767|O5|Outcome|Thiopental 3mcg/mL|"Anesthetic Drug Infusion
Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
512121|NCT00767767|O4|Outcome|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion
Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
512122|NCT00767767|O3|Outcome|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion
Propofol 0.9mcg/mL: IV Propfol infusion for 2 hours."
512123|NCT00767767|O2|Outcome|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion
Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
512124|NCT00767767|O1|Outcome|Placebos|"Saline Infusion
Placebos: IV Saline infusion for 2 hours."
512125|NCT00767767|E5|Reported Event|Thiopental 3mcg/mL|"Anesthetic Drug Infusion
Thiopental 3mcg/mL: IV Thiopental 3mcg/mL infusion for 2 hours"
512126|NCT00767767|E4|Reported Event|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion
Thiopental 1.5mcg/mL: IV Thiopental 1.5mcg/mL infusion for 2 hours"
512127|NCT00767767|E3|Reported Event|Propofol 0.90mcg/mL|"Anesthetic Drug Infusion
Propofol 0.90mcg/mL: IV Propofol infusion for 2 hours."
512128|NCT00767767|E2|Reported Event|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion
Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
512129|NCT00767767|E1|Reported Event|Placebos|"Saline Infusion
Placebos: IV Saline infusion for 2 hours."
512130|NCT00767806|B3|Baseline|Total|Total of all reporting groups
512131|NCT00767806|B2|Baseline|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512132|NCT00767806|B1|Baseline|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512133|NCT00767806|P2|Participant Flow|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512134|NCT00767806|P1|Participant Flow|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512135|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512136|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512137|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512138|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512139|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512140|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512141|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512142|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512143|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512144|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512145|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512146|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512147|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512148|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512149|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512150|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512602|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512151|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512152|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512153|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512154|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512155|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512156|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512157|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512158|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512159|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512160|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512161|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512162|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512163|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512164|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512165|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512166|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512167|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512168|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512169|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512170|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512171|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512172|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512173|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512174|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512175|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512176|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512177|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512178|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512179|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512180|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512181|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512182|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512183|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512184|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512185|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512186|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512187|NCT00767806|E2|Reported Event|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
512188|NCT00767806|E1|Reported Event|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
512189|NCT00768040|B3|Baseline|Total|Total of all reporting groups
512190|NCT00768040|B2|Baseline|Placebo|Matching placebo once daily for 12 weeks
512191|NCT00768040|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
512192|NCT00768040|P2|Participant Flow|Placebo|Matching placebo once daily for 12 weeks
512193|NCT00768040|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
512194|NCT00768040|O2|Outcome|Placebo|Matching placebo once daily for 12 weeks
512195|NCT00768040|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
512196|NCT00768040|E2|Reported Event|Placebo|Matching placebo once daily for 12 weeks
512197|NCT00768040|E1|Reported Event|Aliskiren 300mg|Aliskiren 300 mg once daily for 12 weeks
512198|NCT00768053|B1|Baseline|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512199|NCT00768053|P1|Participant Flow|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512200|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512201|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512202|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512203|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512319|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512204|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512205|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512206|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512207|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512208|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512209|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512210|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512211|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512212|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512213|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512214|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512215|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512216|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512217|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512218|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512219|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512220|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512221|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512222|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512223|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512224|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512225|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512226|NCT00768053|E1|Reported Event|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
512227|NCT00768066|B4|Baseline|Total|Total of all reporting groups
512228|NCT00768066|B3|Baseline|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512229|NCT00768066|B2|Baseline|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512230|NCT00768066|B1|Baseline|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512231|NCT00768066|P3|Participant Flow|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512232|NCT00768066|P2|Participant Flow|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512233|NCT00768066|P1|Participant Flow|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512234|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512276|NCT00768222|B1|Baseline|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512603|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512320|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
512732|NCT00754767|B3|Baseline|Total|Total of all reporting groups
512235|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512236|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512237|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512238|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512239|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512240|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512241|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512242|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512243|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512244|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512245|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512246|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512247|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512248|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512249|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512250|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512251|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512252|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512253|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512254|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512255|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512256|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512257|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512258|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512259|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512260|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512261|NCT00768066|E3|Reported Event|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512262|NCT00768066|E2|Reported Event|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512263|NCT00768066|E1|Reported Event|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
512264|NCT00768118|B1|Baseline|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
512265|NCT00768118|P1|Participant Flow|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
512266|NCT00768118|O1|Outcome|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
512267|NCT00768118|E1|Reported Event|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
512268|NCT00768144|B1|Baseline|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
512269|NCT00768144|P1|Participant Flow|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
512270|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
512271|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
512272|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
512273|NCT00768144|E1|Reported Event|Sunitinib|Sunitinib : Taken orally once a day in the evening
512274|NCT00768222|B3|Baseline|Total|Total of all reporting groups
512275|NCT00768222|B2|Baseline|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512277|NCT00768222|P2|Participant Flow|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512278|NCT00768222|P1|Participant Flow|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512279|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512280|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512281|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512282|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512283|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512284|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512285|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512286|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512287|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512288|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512289|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512290|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512291|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512292|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512293|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512294|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512295|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512296|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512297|NCT00768222|E2|Reported Event|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
512298|NCT00768222|E1|Reported Event|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
512299|NCT00768300|B3|Baseline|Total|Total of all reporting groups
512300|NCT00768300|B2|Baseline|Placebo|Placebo to match ambrisentan administered orally once daily
512301|NCT00768300|B1|Baseline|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512302|NCT00768300|P2|Participant Flow|Placebo|Placebo to match ambrisentan administered orally once daily
512303|NCT00768300|P1|Participant Flow|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512304|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
512305|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512306|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
512307|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512308|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
512309|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512310|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
512311|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512312|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
512313|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512314|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
512315|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512316|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
512317|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512321|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512322|NCT00768300|E2|Reported Event|Placebo|Placebo to match ambrisentan administered orally once daily
512323|NCT00768300|E1|Reported Event|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
512324|NCT00768430|B3|Baseline|Total|Total of all reporting groups
512325|NCT00768430|B2|Baseline|Midazolam|Midazolam
512326|NCT00768430|B1|Baseline|Ketamine|Ketamine
512327|NCT00768430|P2|Participant Flow|Midazolam|single infusion of midazolam being used as an active control for the study
512328|NCT00768430|P1|Participant Flow|Ketamine|single infusion of 0.5mg/kg of Ketamine HCL
512329|NCT00768430|O2|Outcome|Midazolam|Midazolam
512330|NCT00768430|O1|Outcome|Ketamine|Ketamine
512331|NCT00768430|E2|Reported Event|Midazolam|Midazolam
512332|NCT00768430|E1|Reported Event|Ketamine|Ketamine
512333|NCT00768521|B1|Baseline|All Participants|All Study Participants from all groups.
512334|NCT00768521|P2|Participant Flow|Placebo Then Tolterodine|Placebo then Tolterodine 4 mg
512335|NCT00768521|P1|Participant Flow|Tolterodine Then Placebo|Tolterodine 4 mg then Placebo
512336|NCT00768521|O2|Outcome|Placebo|
512337|NCT00768521|O1|Outcome|Tolterodine|Tolterodine 4 mg
512338|NCT00768521|O2|Outcome|Placebo|
512339|NCT00768521|O1|Outcome|Tolterodine|Tolterodine 4 mg
512340|NCT00768521|E2|Reported Event|Placebo|
512341|NCT00768521|E1|Reported Event|Tolterodine|Tolterodine 4 mg
512342|NCT00768560|B7|Baseline|Total|Total of all reporting groups
512343|NCT00768560|B6|Baseline|Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each|
512344|NCT00768560|B5|Baseline|Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each|
512345|NCT00768560|B4|Baseline|Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each|
512346|NCT00768560|B3|Baseline|Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each|
512347|NCT00768560|B2|Baseline|Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each|
512348|NCT00768560|B1|Baseline|Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each|
512349|NCT00768560|P6|Participant Flow|Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each|
512350|NCT00768560|P5|Participant Flow|Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each|
512351|NCT00768560|P4|Participant Flow|Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each|
512352|NCT00768560|P3|Participant Flow|Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each|
512353|NCT00768560|P2|Participant Flow|Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each|
512354|NCT00768560|P1|Participant Flow|Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each|
512355|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
512356|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
512357|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
512358|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
512359|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
512360|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
512361|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
512362|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
512363|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
512364|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
512365|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
512366|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
512367|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
512368|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
512369|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
512370|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
512371|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
512372|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
512373|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
512374|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
512375|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
512604|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512376|NCT00768560|E3|Reported Event|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
512377|NCT00768560|E2|Reported Event|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
512378|NCT00768560|E1|Reported Event|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
512379|NCT00768599|B4|Baseline|Total|Total of all reporting groups
512380|NCT00768599|B3|Baseline|Control|Vehicle Foam
512381|NCT00768599|B2|Baseline|Test Drug|Econazole Nitrate Foam 1%
512382|NCT00768599|B1|Baseline|Reference Drug|Econazole Nitrate Cream 1%
512383|NCT00768599|P3|Participant Flow|Control|Vehicle Foam
512384|NCT00768599|P2|Participant Flow|Test Drug|Econazole Nitrate Foam 1%
512385|NCT00768599|P1|Participant Flow|Reference Drug|Econazole Nitrate Cream 1%
512386|NCT00768599|O3|Outcome|Control|Vehicle Foam
512387|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
512388|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
512389|NCT00768599|O3|Outcome|Control|Vehicle Foam
512390|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
512391|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
512392|NCT00768599|O3|Outcome|Control|Vehicle Foam
512393|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
512394|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
512395|NCT00768599|O3|Outcome|Control|Vehicle Foam
512396|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
512397|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
512398|NCT00768599|O3|Outcome|Control|Vehicle Foam
512399|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
512400|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
512401|NCT00768599|O3|Outcome|Control|Vehicle Foam
512402|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
512403|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
512404|NCT00768599|E3|Reported Event|Control|Vehicle Foam
512405|NCT00768599|E2|Reported Event|Test Drug|Econazole Nitrate Foam 1%
512406|NCT00768599|E1|Reported Event|Reference Drug|Econazole Nitrate Cream 1%
512407|NCT00768651|B1|Baseline|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:
Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:
Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.
Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
512408|NCT00768651|P1|Participant Flow|Sitagliptin + Pantoprazole|"Intervention Details:
Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months, followed by a three-month washout.
Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months, followed by a three-month washout."
512409|NCT00768651|O1|Outcome|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:
Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout.
Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.
Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
512410|NCT00768651|O1|Outcome|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:
Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:
Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.
Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
512411|NCT00768651|E1|Reported Event|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:
Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:
Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.
Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
512412|NCT00768755|B5|Baseline|Total|Total of all reporting groups
512413|NCT00768755|B4|Baseline|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512414|NCT00768755|B3|Baseline|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512415|NCT00768755|B2|Baseline|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512431|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512458|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
512416|NCT00768755|B1|Baseline|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
512417|NCT00768755|P4|Participant Flow|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512418|NCT00768755|P3|Participant Flow|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512419|NCT00768755|P2|Participant Flow|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512420|NCT00768755|P1|Participant Flow|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
512421|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512422|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512423|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512424|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512425|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512426|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512427|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512428|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512429|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512430|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512432|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512433|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512434|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512435|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512436|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512437|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512438|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512439|NCT00768755|E4|Reported Event|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512440|NCT00768755|E3|Reported Event|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512441|NCT00768755|E2|Reported Event|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
512442|NCT00768755|E1|Reported Event|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
512443|NCT00768898|B1|Baseline|Overall|All enrolled participants
512444|NCT00768898|P1|Participant Flow|Overall|All enrolled participants
512445|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
512446|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
512447|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
512448|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
512449|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
512450|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
512451|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
512452|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
512453|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
512454|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
512455|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
512456|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
512457|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
512459|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green were instilled in each eye.
512460|NCT00768898|E3|Reported Event|10.0 Microliters Lissamine Green|10.0 microliters lissamine green
512461|NCT00768898|E2|Reported Event|5.0 Microliters Lissamine Green|5.0 microliters lissamine green
512462|NCT00768898|E1|Reported Event|2.5 Microliters Lissamine Green|2.5 microliters lissamine green
512463|NCT00768989|B3|Baseline|Total|Total of all reporting groups
512464|NCT00768989|B2|Baseline|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512465|NCT00768989|B1|Baseline|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
512466|NCT00768989|P2|Participant Flow|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512467|NCT00768989|P1|Participant Flow|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
512468|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512469|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512470|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512471|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512472|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512473|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512474|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512475|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512476|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512477|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512478|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512479|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512480|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512481|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512482|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512483|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512484|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512485|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512486|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512487|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512488|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512489|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512490|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512491|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512492|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512493|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512494|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512495|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
512496|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512497|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512498|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512499|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512500|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512501|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily
512502|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512503|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512606|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512504|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512505|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512506|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512507|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily
512508|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512509|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512510|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
512511|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
512512|NCT00768989|E2|Reported Event|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
512513|NCT00768989|E1|Reported Event|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/Emtricitabine, 300 mg/200 mg once daily
512514|NCT00769015|B3|Baseline|Total|Total of all reporting groups
512515|NCT00769015|B2|Baseline|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
512516|NCT00769015|B1|Baseline|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
512517|NCT00769015|P2|Participant Flow|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
512518|NCT00769015|P1|Participant Flow|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
512519|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
512520|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
512521|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
512522|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
512523|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
512538|NCT00769067|P2|Participant Flow|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512605|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512524|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
512525|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
512526|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
512527|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
512528|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
512529|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
512530|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
512531|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
512532|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
512533|NCT00769015|E2|Reported Event|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
512534|NCT00769015|E1|Reported Event|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
512535|NCT00769067|B3|Baseline|Total|Total of all reporting groups
512536|NCT00769067|B2|Baseline|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512537|NCT00769067|B1|Baseline|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512592|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512539|NCT00769067|P1|Participant Flow|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512540|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512541|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512542|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512543|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512544|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512545|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512546|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512547|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512548|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512549|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512550|NCT00769067|O1|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512551|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512552|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512553|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512554|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512555|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512556|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512557|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512558|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512559|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512560|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512561|NCT00769067|E2|Reported Event|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512562|NCT00769067|E1|Reported Event|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
512563|NCT00769119|B3|Baseline|Total|Total of all reporting groups
512564|NCT00769119|B2|Baseline|Placebo|Placebo, 2 tablets twice daily (bid)
512565|NCT00769119|B1|Baseline|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512566|NCT00769119|P2|Participant Flow|Placebo|Placebo, 2 tablets twice daily (bid)
512567|NCT00769119|P1|Participant Flow|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512568|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512569|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512570|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512571|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512572|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512573|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512574|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512575|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512576|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512577|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512578|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512579|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512580|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512581|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512582|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512583|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512584|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512585|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512586|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512587|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512588|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512589|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512590|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
512591|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
512611|NCT00769132|P4|Participant Flow|Sequence 4: A/D/B/C|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days
B = ER niacin 2 g once daily for 7 days
C = laropiprant 40 mg once daily for 7 days
D = placebo once daily for 7 days"
512612|NCT00769132|P3|Participant Flow|Sequence 3: B/A/C/D|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days
C = laropiprant 40 mg once daily for 7 days
D = placebo once daily for 7 days"
512613|NCT00769132|P2|Participant Flow|Sequence 2: C/B/D/A|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days
C = laropiprant 40 mg once daily for 7 days
D = placebo once daily for 7 days"
512614|NCT00769132|P1|Participant Flow|Sequence 1: D/C/A/B|"A = Extended Release (ER) niacin 2 g/laropiprant 40 mg once daily for 7 days
B = ER niacin 2 g once daily for 7 days
C = laropiprant 40 mg once daily for 7 days
D = placebo once daily for 7 days"
512615|NCT00769132|O4|Outcome|Placebo|Placebo daily for 7 days
512616|NCT00769132|O3|Outcome|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
512617|NCT00769132|O2|Outcome|ER Niacin 2 g|ER niacin 2 g daily for 7 days
512618|NCT00769132|O1|Outcome|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg daily for 7 days
512619|NCT00769132|O4|Outcome|Placebo|Placebo daily for 7 days
512620|NCT00769132|O3|Outcome|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
512621|NCT00769132|O2|Outcome|ER Niacin 2 g|ER niacin 2 g daily for 7 days
512622|NCT00769132|O1|Outcome|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg daily for 7 days
512623|NCT00769132|E4|Reported Event|Placebo|Placebo once daily for 7 days
512624|NCT00769132|E3|Reported Event|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
512625|NCT00769132|E2|Reported Event|ER Niacin 2 g|ER niacin 2 g once daily for 7 days
512626|NCT00769132|E1|Reported Event|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg once daily for 7 days
512627|NCT00769184|B1|Baseline|Corticosteroid+LCD vs Corticosteroid+Placebo|"one side of body: corticosteroid and liquor carbonis distillate (LCD) treatment applied twice a day, for 2 weeks, then LCD-only twice a day, for 4 weeks, then no treatment for 6 weeks
opposite side of body: corticosteroid and placebo vehicle solution twice a day, for 2 weeks, then placebo vehicle solution-only twice a day, for 4 weeks, then no treatment for 6 weeks"
512628|NCT00769184|P2|Participant Flow|Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left)|"Corticosteroid + LCD on right side of body, Corticosteroid + Placebo on left side of body (n=8).
On right side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks
On left side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks"
512629|NCT00769184|P1|Participant Flow|Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right)|"Corticosteroid + LCD on left side of body, Corticosteroid + Placebo on right side of body (n=7).
On left side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks
On right side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks"
512630|NCT00769184|O2|Outcome|Corticosteroid + Placebo|Corticosteroid + placebo solution applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
512631|NCT00769184|O1|Outcome|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution-only applied to one side of the body twice per day for 4 weeks.
512632|NCT00769184|O2|Outcome|Corticosteroid + Placebo|Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
512633|NCT00769184|O1|Outcome|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
512634|NCT00769184|E2|Reported Event|Corticosteroid + Placebo|Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
512635|NCT00769184|E1|Reported Event|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
512636|NCT00769314|B3|Baseline|Total|Total of all reporting groups
512637|NCT00769314|B2|Baseline|Placebo Group|muco-adhesive buccal tablet with placebo/Intent-to-Treat population
512638|NCT00769314|B1|Baseline|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet/Intent-to-Treat population
512639|NCT00769314|P2|Participant Flow|Placebo Group|muco-adhesive buccal tablet with placebo
512640|NCT00769314|P1|Participant Flow|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512641|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
512642|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512643|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
512644|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512645|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
512646|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512647|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
512648|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512649|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
512650|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512651|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
512652|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512653|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
512654|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512655|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
512656|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512657|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
512658|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512659|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
512660|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512661|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
512662|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512663|NCT00769314|E2|Reported Event|Placebo Group|muco-adhesive buccal tablet with placebo
512664|NCT00769314|E1|Reported Event|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
512665|NCT00754624|B1|Baseline|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
512666|NCT00754624|P1|Participant Flow|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
512667|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
512668|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
512669|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
512670|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
512671|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
512672|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
512673|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
512674|NCT00754624|E1|Reported Event|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
512675|NCT00754650|B1|Baseline|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
512676|NCT00754650|P1|Participant Flow|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
512677|NCT00754650|O1|Outcome|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
512678|NCT00754650|O1|Outcome|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
512679|NCT00754650|E1|Reported Event|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
512680|NCT00754741|B4|Baseline|Total|Total of all reporting groups
512681|NCT00754741|B3|Baseline|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512682|NCT00754741|B2|Baseline|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512683|NCT00754741|B1|Baseline|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512684|NCT00754741|P3|Participant Flow|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512685|NCT00754741|P2|Participant Flow|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512686|NCT00754741|P1|Participant Flow|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512687|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512688|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512689|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512690|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512691|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512733|NCT00754767|B2|Baseline|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
placebo: Given orally"
512692|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512693|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512694|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512695|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512696|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512697|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512698|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512699|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512700|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512701|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512702|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512703|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512704|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512705|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512706|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512707|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512708|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512709|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512710|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512731|NCT00754741|E1|Reported Event|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512734|NCT00754767|B1|Baseline|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
L-carnitine L-tartrate: Given orally"
512711|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512712|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512713|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512714|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512715|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512716|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512717|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512718|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512719|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512720|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512721|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512722|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512723|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512724|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512725|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512726|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512727|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512728|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
512729|NCT00754741|E3|Reported Event|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
512730|NCT00754741|E2|Reported Event|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
512735|NCT00754767|P2|Participant Flow|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
placebo: Given orally"
512736|NCT00754767|P1|Participant Flow|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
L-carnitine L-tartrate: Given orally"
512737|NCT00754767|O2|Outcome|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
placebo: Given orally"
512738|NCT00754767|O1|Outcome|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
L-carnitine L-tartrate: Given orally"
512739|NCT00754767|E2|Reported Event|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
placebo: Given orally"
512740|NCT00754767|E1|Reported Event|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
L-carnitine L-tartrate: Given orally"
512741|NCT00754793|B3|Baseline|Total|Total of all reporting groups
512742|NCT00754793|B2|Baseline|Placebo|Placebo drug
512743|NCT00754793|B1|Baseline|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
512744|NCT00754793|P2|Participant Flow|Placebo|Placebo drug
512745|NCT00754793|P1|Participant Flow|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
512746|NCT00754793|O2|Outcome|Placebo|Placebo drug
512747|NCT00754793|O1|Outcome|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
512748|NCT00754793|E2|Reported Event|Placebo|Placebo drug
512749|NCT00754793|E1|Reported Event|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
512750|NCT00754832|B1|Baseline|Intent to Treat Study Population|all participants who received at least one dose of either placebo or ginseng in this crossover trial
512751|NCT00754832|P2|Participant Flow|Placebo First Then Ginseng|placebo 1 cap daily escalating to 4 caps daily for 6 weeks followed by 2 weeks washout, then ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
512752|NCT00754832|P1|Participant Flow|Ginseng First Then Placebo|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks followed by 2 weeks washout, then placebo 1 cap daily escalating to 4 caps daily for 6 weeks
512753|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
512754|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
512755|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
512756|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
512757|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
512758|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
512759|NCT00754832|E2|Reported Event|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
512760|NCT00754832|E1|Reported Event|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
512761|NCT00754923|B1|Baseline|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.
sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
512762|NCT00754923|P1|Participant Flow|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.
sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
512763|NCT00754923|O1|Outcome|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.
sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
512764|NCT00754923|O1|Outcome|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.
sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
512765|NCT00754923|E1|Reported Event|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.
sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
512766|NCT00760383|B3|Baseline|Total|Total of all reporting groups
512767|NCT00760383|B2|Baseline|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
512768|NCT00760383|B1|Baseline|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
512769|NCT00760383|P2|Participant Flow|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
512821|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512770|NCT00760383|P1|Participant Flow|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
512853|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
512771|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
512772|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
512773|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
512774|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
512775|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
512776|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
512777|NCT00760383|E2|Reported Event|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
512778|NCT00760383|E1|Reported Event|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.
Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
512779|NCT00760435|B3|Baseline|Total|Total of all reporting groups
512780|NCT00760435|B2|Baseline|Placebo Arm|"98 received Placebo plus IVIG
Placebo: Placebo (same volume as active drug)"
512781|NCT00760435|B1|Baseline|Infliximab Arm|"98 recieved infliximab plus IVIG
Infliximab: 5 mg/kg IV over 2 hours once"
512782|NCT00760435|P2|Participant Flow|Placebo Arm|"98 received Placebo plus IVIG
Placebo: Placebo (same volume as active drug)"
512783|NCT00760435|P1|Participant Flow|Infliximab Arm|"98 recieved infliximab plus IVIG
Infliximab: 5 mg/kg IV over 2 hours once"
512784|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
512785|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
512786|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
512787|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
512788|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
512789|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
512790|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
512791|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
512792|NCT00760435|E2|Reported Event|Placebo Arm|"98 received Placebo plus IVIG
Placebo: Placebo (same volume as active drug)"
512793|NCT00760435|E1|Reported Event|Infliximab Arm|"98 recieved infliximab plus IVIG
Infliximab: 5 mg/kg IV over 2 hours once"
512794|NCT00760461|B1|Baseline|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
512795|NCT00760461|P1|Participant Flow|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
512796|NCT00760461|O1|Outcome|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
512797|NCT00760461|E1|Reported Event|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
512798|NCT00760474|B1|Baseline|Entire Study Population|"Participants who met entrance criteria received placebo for 1 week (Day 1 to 8) then were randomized in a 1:1 ratio to blinded treatment sequence to receive either:
Pregabalin, then placebo: Pregabalin 75 mg PO BID Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38 and included dose escalation through Day 51 followed by placebo taper Day 52 to 58.
Or placebo, then Pregabalin: Placebo matching study treatment was administered in a similar fashion to Pregabalin treatment beginning Period 1/Day 9 and included dose escalation, taper and an 8-day placebo washout period. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58."
512851|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: Hypoglycemia Fear Survey
512895|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
512799|NCT00760474|P2|Participant Flow|Placebo First, Then Pregabalin|Placebo matching study treatment was administered beginning Period 1/Day9. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58.
512854|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
512800|NCT00760474|P1|Participant Flow|Pregabalin First, Then Placebo|Pregabalin 75 milligrams (mg) by mouth (PO) twice daily (BID) Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38.
512801|NCT00760474|O1|Outcome|All Study Treatment: Pregabalin, Placebo|"Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2."
512802|NCT00760474|O1|Outcome|All Study Treatment: Pregabalin, Placebo|"Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2."
512803|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512804|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512805|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512806|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512807|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512808|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512809|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512810|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512811|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512812|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512813|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512814|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512815|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512816|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512817|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512818|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512819|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512820|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512852|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: Hypoglycemia Fear Survey
512855|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
512856|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
512857|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
512822|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512823|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512824|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512825|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512826|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512827|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512828|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512829|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512830|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512831|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512832|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512833|NCT00760474|E2|Reported Event|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
512834|NCT00760474|E1|Reported Event|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
512835|NCT00760487|B1|Baseline|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
512836|NCT00760487|P1|Participant Flow|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
512837|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
512838|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
512839|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
512840|NCT00760487|E1|Reported Event|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
512841|NCT00760526|B3|Baseline|Total|Total of all reporting groups
512842|NCT00760526|B2|Baseline|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
512843|NCT00760526|B1|Baseline|Continuous Glucose Montoring|Treatment group
512844|NCT00760526|P2|Participant Flow|Standard Glucose Monitoring With Home Glucose Meter|Participants in the control group were given a FreeStyle Flash blood glucose meter and test strips and asked to perform blood glucose monitoring at least four times daily. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
512845|NCT00760526|P1|Participant Flow|Continuous Glucose Montoring|Participants randomized to the CGM (treatment) group were provided with an unblinded CGM device, sensors, and a FreeStyle Flash blood glucose meter and test strips. A Free- Style Navigator was provided unless the participant was already using a Medtronic Paradigm insulin pump, in which case a MiniMed MiniLink REAL-Time Transmitter could be used. Parents were instructed on device use and daily sensor use was encouraged. They were instructed to continue testing with the home blood glucose meter >=4 times/day and to verify the accuracy of the CGM glucose measurement with the meter before making management decisions. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
512846|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: CGM Satisfaction
512847|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: Blood Glucose Monitoring System Rating Scale
512848|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: Blood Glucose Monitoring System Rating Scale
512849|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: PAID
512850|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: PAID
512894|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
512859|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
512860|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
512861|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
512862|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
512863|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
512864|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
512865|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
512866|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
512867|NCT00760526|E2|Reported Event|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
512868|NCT00760526|E1|Reported Event|Continuous Glucose Montoring|Treatment group
512869|NCT00760552|B3|Baseline|Total|Total of all reporting groups
512870|NCT00760552|B2|Baseline|Arm 2|"VA patients with uncontrolled HTN.
Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
512871|NCT00760552|B1|Baseline|Arm 1|"VA patients with uncontrolled HTN.
High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
512872|NCT00760552|P2|Participant Flow|Arm 2|"VA patients with uncontrolled HTN.
Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
512873|NCT00760552|P1|Participant Flow|Arm 1|"VA patients with uncontrolled HTN.
High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
512874|NCT00760552|O2|Outcome|Arm 2|"VA patients with uncontrolled HTN.
Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
512875|NCT00760552|O1|Outcome|Arm 1|"VA patients with uncontrolled HTN.
High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
512876|NCT00760552|E2|Reported Event|Arm 2|"VA patients with uncontrolled HTN.
Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
512877|NCT00760552|E1|Reported Event|Arm 1|"VA patients with uncontrolled HTN.
High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
512878|NCT00760578|B5|Baseline|Total|Total of all reporting groups
512879|NCT00760578|B4|Baseline|Placebo|Microcrystaline cellulose once daily
512880|NCT00760578|B3|Baseline|Pioglitazone|Pioglitazone 45 mg once daily
512881|NCT00760578|B2|Baseline|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
512882|NCT00760578|B1|Baseline|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
512883|NCT00760578|P4|Participant Flow|Placebo|Microcrystaline cellulose once daily
512884|NCT00760578|P3|Participant Flow|Pioglitazone|Pioglitazone 45 mg once daily
512885|NCT00760578|P2|Participant Flow|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
512886|NCT00760578|P1|Participant Flow|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
512887|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
512888|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
512889|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
512890|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
512891|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
512892|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
512893|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
512896|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
512897|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
512898|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
512899|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
512900|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
512901|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
512902|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
512903|NCT00760578|O4|Outcome|Placebo|Microcrystalline cellulose taken once daily for 28 days
512904|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
512905|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
512906|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
512907|NCT00760578|O4|Outcome|Placebo|Microcrystalline cellulose taken once daily for 28 days
512908|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
512909|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
512910|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
512911|NCT00760578|O4|Outcome|Placebo|Placebo (microcrystalline cellulose) taken once daily for 28 days
512912|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
512913|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
512914|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
512915|NCT00760578|E4|Reported Event|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
512916|NCT00760578|E3|Reported Event|Pioglitazone|Pioglitazone 45 mg once daily
512917|NCT00760578|E2|Reported Event|Placebo|Microcrystaline cellulose once daily
512918|NCT00760578|E1|Reported Event|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
512919|NCT00760617|B4|Baseline|Total|Total of all reporting groups
512920|NCT00760617|B3|Baseline|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512921|NCT00760617|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512922|NCT00760617|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512923|NCT00760617|P3|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512924|NCT00760617|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512925|NCT00760617|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512926|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512927|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512928|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512929|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512930|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512931|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512932|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512933|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512934|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512935|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512936|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512937|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512938|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512939|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512940|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512941|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512942|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512943|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512944|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512945|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512946|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512947|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512948|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512949|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512950|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512951|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512952|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512953|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512954|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512955|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512956|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512957|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512958|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512959|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512960|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512961|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512962|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512963|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512964|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512965|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512966|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512967|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512968|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512969|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512970|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512971|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512972|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512973|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512974|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512975|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512976|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512977|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512978|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512979|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512980|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512981|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512982|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512983|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512984|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512985|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512986|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512987|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512988|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512989|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512990|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512991|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512992|NCT00760617|E3|Reported Event|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
512993|NCT00760617|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
512994|NCT00760617|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
512995|NCT00760669|B1|Baseline|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
513023|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513024|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513074|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
513027|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513028|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513084|NCT00761007|P3|Participant Flow|Ibodutant 60 mg|oral tablet, once daily
512996|NCT00760669|P1|Participant Flow|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
512997|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
512998|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
512999|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
513000|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
513001|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
513002|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
513003|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
513025|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513026|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513004|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
513005|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
513006|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
513007|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
513008|NCT00760669|E1|Reported Event|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
513009|NCT00760747|B3|Baseline|Total|Total of all reporting groups
513010|NCT00760747|B2|Baseline|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513011|NCT00760747|B1|Baseline|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513012|NCT00760747|P2|Participant Flow|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513013|NCT00760747|P1|Participant Flow|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day), orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513014|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513015|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513016|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513017|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513018|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513019|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513020|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513021|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513022|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513029|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513030|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513031|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513032|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513033|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513034|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513035|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513036|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513037|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513038|NCT00760747|E2|Reported Event|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
513039|NCT00760747|E1|Reported Event|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
513040|NCT00760838|B3|Baseline|Total|Total of all reporting groups
513041|NCT00760838|B2|Baseline|Azithromycin|"Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards"
513042|NCT00760838|B1|Baseline|Placebo|"Placebo
1x/day during 5 days 3x/week afterwards"
513043|NCT00760838|P2|Participant Flow|Azithromycin|"Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards"
513044|NCT00760838|P1|Participant Flow|Placebo|"Placebo
1x/day during 5 days 3x/week afterwards"
513045|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards"
513046|NCT00760838|O1|Outcome|Placebo|"Placebo
1x/day during 5 days 3x/week afterwards"
513047|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards"
513048|NCT00760838|O1|Outcome|Placebo|"Placebo
1x/day during 5 days 3x/week afterwards"
513049|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards"
513050|NCT00760838|O1|Outcome|Placebo|"Placebo
1x/day during 5 days 3x/week afterwards"
513051|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards"
513052|NCT00760838|O1|Outcome|Placebo|"Placebo
1x/day during 5 days 3x/week afterwards"
513053|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards"
513054|NCT00760838|O1|Outcome|Placebo|"Placebo
1x/day during 5 days 3x/week afterwards"
513055|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards"
513056|NCT00760838|O1|Outcome|Placebo|"Placebo
1x/day during 5 days 3x/week afterwards"
513057|NCT00760838|E2|Reported Event|Azithromycin|"Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards"
513058|NCT00760838|E1|Reported Event|Placebo|"Placebo
1x/day during 5 days 3x/week afterwards"
513059|NCT00760877|B3|Baseline|Total|Total of all reporting groups
513060|NCT00760877|B2|Baseline|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
513061|NCT00760877|B1|Baseline|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
513062|NCT00760877|P2|Participant Flow|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
513063|NCT00760877|P1|Participant Flow|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
513064|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
513065|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
513066|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
513067|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
513068|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
513069|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
513070|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
513071|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
513072|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
513073|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
513075|NCT00760877|E3|Reported Event|Imatinib Subset That Crossed Over to Nilotinib|Imatinib subset that crossed over to nilotinib
513076|NCT00760877|E2|Reported Event|Imatinib|Imatinib
513077|NCT00760877|E1|Reported Event|Nilotinib|Nilotinib
513078|NCT00761007|B5|Baseline|Total|Total of all reporting groups
513079|NCT00761007|B4|Baseline|Placebo|oral tablet, once daily
513085|NCT00761007|P2|Participant Flow|Ibodutant 30 mg|oral tablet, once daily
513086|NCT00761007|P1|Participant Flow|Ibodutant 10 mg|oral tablet, once daily
513087|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
513088|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
513089|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
513090|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
513091|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
513092|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
513093|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
513094|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
513095|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
513096|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
513097|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
513098|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
513099|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
513100|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
513101|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
513102|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
513103|NCT00761007|E4|Reported Event|Placebo|oral tablet, once daily
513104|NCT00761007|E3|Reported Event|Ibodutant 60 mg|oral tablet, once daily
513105|NCT00761007|E2|Reported Event|Ibodutant 30 mg|oral tablet, once daily
513106|NCT00761007|E1|Reported Event|Ibodutant 10 mg|oral tablet, once daily
513107|NCT00761137|B1|Baseline|All Study Participants|This study was a double-blind, randomized, placebo controlled, two-phased, Latin-square crossover study. Subjects received three single-doses of tropicamide or placebo in random order, with a 7-day washout period.
513108|NCT00761137|P1|Participant Flow|All Participants|subjects randomly received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide
513109|NCT00761137|O4|Outcome|Tropicamide 3 mg|Each subject randomly received blinded a thin film containing 3 mg active drug ingredient
513110|NCT00761137|O3|Outcome|Tropicamide - 1 mg|Each subject randomly received blinded a thin film containing 1 mg active drug ingredient
513111|NCT00761137|O2|Outcome|Tropicamide - 0.3 mg|Each subject randomly received blinded a thin film containing 0.3 mg active drug ingredient
513112|NCT00761137|O1|Outcome|Tropicamide - Placebo|Each subject randomly received blinded a placebo thin film containing no active drug ingredient
513113|NCT00761137|O4|Outcome|Tropicamide 3 mg|Each subject randomly received blinded a thin film containing 3 mg active drug ingredient
513114|NCT00761137|O3|Outcome|Tropicamide - 1 mg|Each subject randomly received blinded a thin film containing 1 mg active drug ingredient
513115|NCT00761137|O2|Outcome|Tropicamide - 0.3 mg|Each subject randomly received blinded a thin film containing 0.3 mg active drug ingredient
513116|NCT00761137|O1|Outcome|Tropicamide - Placebo|Each subject randomly received blinded a placebo thin film containing no active drug ingredient
513117|NCT00761137|E1|Reported Event|All Participants|subjects received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide
513118|NCT00761150|B4|Baseline|Total|Total of all reporting groups
513119|NCT00761150|B3|Baseline|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
513120|NCT00761150|B2|Baseline|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
513121|NCT00761150|B1|Baseline|Nonrandomized|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period.
513122|NCT00761150|P3|Participant Flow|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
513123|NCT00761150|P2|Participant Flow|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
513124|NCT00761150|P1|Participant Flow|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
513125|NCT00761150|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
513126|NCT00761150|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
513127|NCT00761150|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
513128|NCT00761150|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
513129|NCT00761150|E3|Reported Event|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
513130|NCT00761150|E2|Reported Event|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
513131|NCT00761150|E1|Reported Event|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
513132|NCT00761176|B3|Baseline|Total|Total of all reporting groups
513133|NCT00761176|B2|Baseline|Standard of Care|Standardized wound care is used
513134|NCT00761176|B1|Baseline|Active|The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.
513135|NCT00761176|P2|Participant Flow|Active|Provant Therapy Device
513136|NCT00761176|P1|Participant Flow|Standard of Care|standardized care will be used for wound care on patients randomized to this arm.
513137|NCT00761176|O2|Outcome|Active Provant Device|"Active Device
The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device."
513138|NCT00761176|O1|Outcome|Standard of Care|Standard of Care will be utilized without the device.
513139|NCT00761176|E2|Reported Event|Active|Provant Therapy Device
513140|NCT00761176|E1|Reported Event|Standard of Care|standardized care will be used for wound care on patients randomized to this arm.
513198|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
513199|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
513141|NCT00761189|B1|Baseline|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513142|NCT00761189|P1|Participant Flow|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513143|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513144|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513145|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513146|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513147|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513148|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513149|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513150|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513151|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513152|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513153|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513154|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513155|NCT00761189|E1|Reported Event|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
513156|NCT00761202|B3|Baseline|Total|Total of all reporting groups
513157|NCT00761202|B2|Baseline|Sodium Hyaluronate|
513158|NCT00761202|B1|Baseline|Carboxymethylcellulose and Glycerin|
513159|NCT00761202|P2|Participant Flow|Sodium Hyaluronate|
513160|NCT00761202|P1|Participant Flow|Carboxymethylcellulose and Glycerin|
513161|NCT00761202|O2|Outcome|Sodium Hyaluronate|
513162|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
513163|NCT00761202|O2|Outcome|Sodium Hyaluronate|
513164|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
513165|NCT00761202|O2|Outcome|Sodium Hyaluronate|
513166|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
513167|NCT00761202|O2|Outcome|Sodium Hyaluronate|
513168|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
513169|NCT00761202|O2|Outcome|Sodium Hyaluronate|
513170|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
513171|NCT00761202|O2|Outcome|Sodium Hyaluronate|
513172|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
513173|NCT00761202|E2|Reported Event|Sodium Hyaluronate|
513174|NCT00761202|E1|Reported Event|Carboxymethylcellulose and Glycerin|
513175|NCT00761215|B4|Baseline|Total|Total of all reporting groups
513176|NCT00761215|B3|Baseline|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
513177|NCT00761215|B2|Baseline|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
513178|NCT00761215|B1|Baseline|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
513179|NCT00761215|P3|Participant Flow|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
513180|NCT00761215|P2|Participant Flow|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
513181|NCT00761215|P1|Participant Flow|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
513182|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
513183|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
513184|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
513185|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
513186|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
513187|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
513188|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
513189|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
513190|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
513191|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
513192|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
513193|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
513194|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
513195|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
513196|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
513197|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
513200|NCT00761215|E3|Reported Event|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
513201|NCT00761215|E2|Reported Event|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
513202|NCT00761215|E1|Reported Event|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
513203|NCT00761280|B3|Baseline|Total|Total of all reporting groups
513204|NCT00761280|B2|Baseline|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513205|NCT00761280|B1|Baseline|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513206|NCT00761280|P2|Participant Flow|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513207|NCT00761280|P1|Participant Flow|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513208|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513209|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513210|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513211|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513212|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513213|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513214|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513259|NCT00761462|B2|Baseline|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
513260|NCT00761462|B1|Baseline|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
513945|NCT00771277|B1|Baseline|Arm 1|Family experience of concerns and providing support to TBI patient
513215|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513266|NCT00761462|O1|Outcome|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
513267|NCT00761462|E2|Reported Event|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
513216|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513217|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513218|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513219|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513220|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513221|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513222|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513223|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513224|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513225|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513226|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513227|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513228|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513330|NCT00761592|E1|Reported Event|Botulinum Toxin Type A 900kDa|
513229|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513230|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513231|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513232|NCT00761280|E2|Reported Event|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.
OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;
OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.
Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
513233|NCT00761280|E1|Reported Event|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.
Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
513234|NCT00761306|B1|Baseline|Vortioxetine 5 or 10 mg/Day|tablets; orally
513235|NCT00761306|P1|Participant Flow|Vortioxetine 5 or 10 mg/Day|tablets; orally
513236|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
513237|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
513238|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
513239|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
513240|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
513241|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
513242|NCT00761306|E1|Reported Event|Vortioxetine 5 or 10 mg/Day|
513243|NCT00761319|B3|Baseline|Total|Total of all reporting groups
513244|NCT00761319|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
513245|NCT00761319|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
513246|NCT00761319|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
513247|NCT00761319|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
513248|NCT00761319|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
513249|NCT00761319|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
513250|NCT00761319|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
513251|NCT00761319|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
513252|NCT00761319|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
513253|NCT00761319|E1|Reported Event|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
513254|NCT00761345|B1|Baseline|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle
gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.
Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle
low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
513255|NCT00761345|P1|Participant Flow|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle
gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.
Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle
low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
513256|NCT00761345|O1|Outcome|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle
gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.
Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle
low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
513257|NCT00761345|E1|Reported Event|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle
gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.
Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle
low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
513258|NCT00761462|B3|Baseline|Total|Total of all reporting groups
514381|NCT00771758|O4|Outcome|Poor - End of Study|Oxycodone IR
513261|NCT00761462|P2|Participant Flow|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
513262|NCT00761462|P1|Participant Flow|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
513263|NCT00761462|O2|Outcome|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
513264|NCT00761462|O1|Outcome|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
513265|NCT00761462|O2|Outcome|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
513268|NCT00761462|E1|Reported Event|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
513269|NCT00761514|B1|Baseline|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
513270|NCT00761514|P1|Participant Flow|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
513271|NCT00761514|O1|Outcome|Open-label Treatment With Adalimumab 40 mg Every Other Week|All subjects received 40 mg adalimumab by subcutaneous injection every other week for up to 24 weeks.
513272|NCT00761514|O1|Outcome|Open-label Treatment With Adalimumab 40 mg Every Other Week|All subjects received 40 mg adalimumab by subcutaneous injection every other week for up to 24 weeks.
513273|NCT00761514|E1|Reported Event|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
513274|NCT00761527|B1|Baseline|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
513275|NCT00761527|P1|Participant Flow|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
513276|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
513277|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
513278|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
513279|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
513280|NCT00761527|E1|Reported Event|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
513281|NCT00761579|B1|Baseline|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
513282|NCT00761579|P1|Participant Flow|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
513283|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
514382|NCT00771758|O3|Outcome|Fair - End of Study|Oxycodone IR
513284|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
513285|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513286|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
513287|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
513288|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513289|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
513290|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
513291|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513292|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
513293|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
513294|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513295|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
513296|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
513297|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513298|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
513299|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
513331|NCT00761605|B1|Baseline|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
513522|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513300|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513301|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
513302|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
513303|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513304|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
513305|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
513306|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513307|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
513308|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
513309|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513310|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
513311|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
513312|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513313|NCT00761579|E1|Reported Event|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
513314|NCT00761592|B3|Baseline|Total|Total of all reporting groups
513315|NCT00761592|B2|Baseline|Botulinum Toxin Type A 150kDa|
513316|NCT00761592|B1|Baseline|Botulinum Toxin Type A 900kDa|
513317|NCT00761592|P2|Participant Flow|Botulinum Toxin Type A 150kDa|
513318|NCT00761592|P1|Participant Flow|Botulinum Toxin Type A 900kDa|
513319|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
513320|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
513321|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
513322|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
513323|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
513324|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
513325|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
513326|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
513327|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
513328|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
513329|NCT00761592|E2|Reported Event|Botulinum Toxin Type A 150kDa|
513332|NCT00761605|P1|Participant Flow|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
513333|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513371|NCT00761631|O6|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
513334|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513335|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513336|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513337|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513338|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513339|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513340|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513341|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513342|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513343|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513344|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513345|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513346|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513347|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513369|NCT00761631|O2|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
513348|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513372|NCT00761631|O5|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
513349|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513350|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513351|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513352|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513353|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513354|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
513355|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
513356|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
513357|NCT00761605|E1|Reported Event|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
513358|NCT00761631|B5|Baseline|Total|Total of all reporting groups
513359|NCT00761631|B4|Baseline|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
513360|NCT00761631|B3|Baseline|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
513361|NCT00761631|B2|Baseline|13vPnC Group 2 (Cohort 1 and 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
513362|NCT00761631|B1|Baseline|13vPnC Group 1 (Cohort 1 and 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
513363|NCT00761631|P6|Participant Flow|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
513364|NCT00761631|P5|Participant Flow|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
513365|NCT00761631|P4|Participant Flow|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
513366|NCT00761631|P3|Participant Flow|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
513367|NCT00761631|P2|Participant Flow|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513368|NCT00761631|P1|Participant Flow|13vPnC Group 1 (Cohort 1)|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC). Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513523|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513370|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513854|NCT00770861|O2|Outcome|Placebo|Matching placebo tablets, oral administration
513373|NCT00761631|O4|Outcome|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
513374|NCT00761631|O3|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
513375|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513376|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513377|NCT00761631|O2|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
513378|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513379|NCT00761631|O6|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
513380|NCT00761631|O5|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
513381|NCT00761631|O4|Outcome|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
513382|NCT00761631|O3|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
513383|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513384|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513385|NCT00761631|O2|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
513386|NCT00761631|O1|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
513387|NCT00761631|O1|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
513388|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513389|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513390|NCT00761631|E12|Reported Event|6-Month Follow-up 13vPnC Group 4|6 -Month Follow-up Telephone Contact for participants in Group 4.
513391|NCT00761631|E11|Reported Event|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
513392|NCT00761631|E10|Reported Event|6-Month Follow-up 13vPnC Group 3|6-month follow-up telephone contact for participants in Group 3.
513393|NCT00761631|E9|Reported Event|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
513394|NCT00761631|E8|Reported Event|6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)|6-month follow-up telephone contact for participants in Group 2 (Cohort 1 and 2).
513395|NCT00761631|E7|Reported Event|6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)|6-month follow-up telephone contact for participants in Group 1 (Cohort 1 and 2).
513396|NCT00761631|E6|Reported Event|13vPnC Group 2 (Cohort 2) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
513397|NCT00761631|E5|Reported Event|13vPnC Group 1 (Cohort 2) Dose 2|13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
513436|NCT00769652|E2|Reported Event|Standard Care|"Standard care
Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
513398|NCT00761631|E4|Reported Event|13vPnC Group 1 (Cohort 2) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
513399|NCT00761631|E3|Reported Event|13vPnC Group 2 (Cohort 1) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
516324|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
513400|NCT00761631|E2|Reported Event|13vPnC Group 1 (Cohort 1) Dose 2|13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513401|NCT00761631|E1|Reported Event|13vPnC Group 1 (Cohort 1) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
513402|NCT00769561|B3|Baseline|Total|Total of all reporting groups
513403|NCT00769561|B2|Baseline|Occlusal Splint|Dental treatment with occlusal splint
513404|NCT00769561|B1|Baseline|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
513405|NCT00769561|P2|Participant Flow|Occlusal Splint|Dental treatment with occlusal splint
513406|NCT00769561|P1|Participant Flow|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
513407|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
513408|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
513409|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
513410|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
513411|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
513412|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
513413|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
513414|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
513415|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
513416|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
513417|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
513418|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
513419|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
513420|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
513421|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
513422|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
513423|NCT00769561|E2|Reported Event|Occlusal Splint|Dental treatment with occlusal splint
513424|NCT00769561|E1|Reported Event|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
513425|NCT00769652|B3|Baseline|Total|Total of all reporting groups
513426|NCT00769652|B2|Baseline|Standard Care|"Standard care
Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
513427|NCT00769652|B1|Baseline|Medical Nutrition Therapy|"Medical nutrition therapy
Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
513428|NCT00769652|P2|Participant Flow|Standard Care|"Standard care
Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
513429|NCT00769652|P1|Participant Flow|Medical Nutrition Therapy|"Medical nutrition therapy
Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
513430|NCT00769652|O2|Outcome|Standard Care|"Standard care
Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
513431|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy
Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
513432|NCT00769652|O2|Outcome|Standard Care|"Standard care
Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
513433|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy
Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
513434|NCT00769652|O2|Outcome|Standard Care|"Standard care
Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
513435|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy
Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
513553|NCT00770289|O1|Outcome|Beck Depression Inventory (BDI)|Participants who were administered BDI.
513437|NCT00769652|E1|Reported Event|Medical Nutrition Therapy|"Medical nutrition therapy
Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
513438|NCT00769704|B3|Baseline|Total|Total of all reporting groups
513439|NCT00769704|B2|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
513440|NCT00769704|B1|Baseline|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
513441|NCT00769704|P2|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose of talimogene laherparepvec was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
513442|NCT00769704|P1|Participant Flow|GM-CSF|Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
513443|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
513444|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
513445|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
513446|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
513447|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
513448|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
513449|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
513450|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
513451|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
513521|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513452|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
513526|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513527|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513453|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
513454|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
513455|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
513456|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
513457|NCT00769704|E2|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
513458|NCT00769704|E1|Reported Event|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
513459|NCT00770029|B3|Baseline|Total|Total of all reporting groups
513460|NCT00770029|B2|Baseline|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
513461|NCT00770029|B1|Baseline|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513462|NCT00770029|P2|Participant Flow|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
513463|NCT00770029|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513464|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
513465|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513466|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
513467|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513468|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
513469|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513470|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
513471|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
514383|NCT00771758|O2|Outcome|Good - End of Study|Oxycodone IR
513472|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
516325|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
513473|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513474|NCT00770029|E2|Reported Event|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
513475|NCT00770029|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513476|NCT00770120|B1|Baseline|Everolimus|"Daily oral Everolimus 10 mg/day
everolimus"
513477|NCT00770120|P1|Participant Flow|Everolimus|"Daily oral Everolimus 10 mg/day
everolimus"
513478|NCT00770120|O1|Outcome|Everolimus|Daily oral Everolimus 10 mg/day
513479|NCT00770120|O1|Outcome|Everolimus|"Daily oral Everolimus 10 mg/day
everolimus"
513480|NCT00770120|O1|Outcome|Everolimus|"Daily oral Everolimus 10 mg/day
everolimus"
513481|NCT00770120|O1|Outcome|Everolimus|"Daily oral Everolimus 10 mg/day
everolimus"
513482|NCT00770120|E1|Reported Event|Everolimus|Daily oral Everolimus 10 mg/day
513483|NCT00770146|B3|Baseline|Total|Total of all reporting groups
513484|NCT00770146|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513485|NCT00770146|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513486|NCT00770146|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513487|NCT00770146|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513488|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513489|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513490|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513491|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513492|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513493|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513494|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513495|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513496|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513497|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513498|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513499|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513500|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513501|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513502|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513503|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513504|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513505|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513506|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513507|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513508|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513509|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513510|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513511|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513512|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513513|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513514|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513515|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513516|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513517|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513518|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513519|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513520|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513524|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513525|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513528|NCT00770146|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
513529|NCT00770146|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
513530|NCT00770211|B3|Baseline|Total|Total of all reporting groups
513531|NCT00770211|B2|Baseline|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
513532|NCT00770211|B1|Baseline|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513533|NCT00770211|P2|Participant Flow|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
513534|NCT00770211|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513535|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
513536|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513537|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
513538|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513539|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
513540|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513541|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
513542|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513543|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
513544|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513545|NCT00770211|E2|Reported Event|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
513546|NCT00770211|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
513547|NCT00770289|B1|Baseline|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
513548|NCT00770289|P1|Participant Flow|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
513549|NCT00770289|O1|Outcome|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion and did not display remission.
513550|NCT00770289|O3|Outcome|Beck Depression Inventory (BDI)|Participants who were administered BDI.
513551|NCT00770289|O2|Outcome|Hamilton Depression Scale (HAM-D7)|Participants who were administered HAM-D7, a subset of clinician-administered rating scale HAM-D17.
513552|NCT00770289|O1|Outcome|Hamilton Depression Scale (HAM-D17)|Participants who were administered HAM-D17.
513554|NCT00770289|O1|Outcome|Hamilton Depression Scale (HAM-D)|Participants who were administered Hamilton depression scales, HAM-D17 and HAM-D7.
513555|NCT00770289|E1|Reported Event|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
513556|NCT00770315|B5|Baseline|Total|Total of all reporting groups
513557|NCT00770315|B4|Baseline|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513558|NCT00770315|B3|Baseline|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513559|NCT00770315|B2|Baseline|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513560|NCT00770315|B1|Baseline|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513561|NCT00770315|P4|Participant Flow|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513562|NCT00770315|P3|Participant Flow|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513563|NCT00770315|P2|Participant Flow|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513564|NCT00770315|P1|Participant Flow|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513565|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513566|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513567|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513568|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513569|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513570|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513571|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513572|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513573|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513574|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513575|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513576|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513577|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513578|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513579|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513580|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513581|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513582|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513583|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513584|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513585|NCT00770315|E4|Reported Event|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513586|NCT00770315|E3|Reported Event|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513587|NCT00770315|E2|Reported Event|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513588|NCT00770315|E1|Reported Event|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
513589|NCT00770341|B4|Baseline|Total|Total of all reporting groups
513590|NCT00770341|B3|Baseline|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
513591|NCT00770341|B2|Baseline|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
513592|NCT00770341|B1|Baseline|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
513593|NCT00770341|P3|Participant Flow|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
513594|NCT00770341|P2|Participant Flow|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
513595|NCT00770341|P1|Participant Flow|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
513596|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
513597|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
513598|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
513599|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
513600|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
513601|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
513602|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
513603|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
513604|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
513605|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
513606|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
513607|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
513608|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
513609|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
513610|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
513611|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
513612|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
513613|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
513614|NCT00770341|E4|Reported Event|DAPTOMYCIN (6 MG/KG)|
513615|NCT00770341|E3|Reported Event|VANCOMYCIN|
513616|NCT00770341|E2|Reported Event|DAPTOMYCIN (4 MG/KG)|
513617|NCT00770341|E1|Reported Event|NOT TREATED|
513618|NCT00770367|B3|Baseline|Total|Total of all reporting groups
513619|NCT00770367|B2|Baseline|Placebo|The analysis period during which participant took the placebo.
513620|NCT00770367|B1|Baseline|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
513621|NCT00770367|P2|Participant Flow|Placebo|The analysis period during which participant took the placebo.
513622|NCT00770367|P1|Participant Flow|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
513623|NCT00770367|O2|Outcome|Placebo|The analysis period during which participant took the placebo.
513624|NCT00770367|O1|Outcome|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
513625|NCT00770367|E2|Reported Event|Placebo|The analysis period during which participant took the placebo.
513626|NCT00770367|E1|Reported Event|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
513627|NCT00770432|B3|Baseline|Total|Total of all reporting groups
513628|NCT00770432|B2|Baseline|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
513629|NCT00770432|B1|Baseline|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
513630|NCT00770432|P2|Participant Flow|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
513631|NCT00770432|P1|Participant Flow|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
513632|NCT00770432|O2|Outcome|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
513633|NCT00770432|O1|Outcome|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
513634|NCT00770432|E2|Reported Event|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
513635|NCT00770432|E1|Reported Event|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
513636|NCT00770484|B3|Baseline|Total|Total of all reporting groups
513637|NCT00770484|B2|Baseline|Placebo Then Propranolol|"Placebo Treatment
Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
514384|NCT00771758|O1|Outcome|Excellent - End of Study|Oxycodone IR
513638|NCT00770484|B1|Baseline|Propranolol Then Placebo|"Active treatment
Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
513639|NCT00770484|P2|Participant Flow|Placebo Then Propranolol|"Placebo Treatment
Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
513640|NCT00770484|P1|Participant Flow|Propranolol Then Placebo|"Active treatment
Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
513641|NCT00770484|O2|Outcome|Placebo|"Placebo Treatment
Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
513642|NCT00770484|O1|Outcome|Propranolol|"Active treatment
Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
513643|NCT00770484|E2|Reported Event|Placebo Then Propranolol|"Placebo Treatment
Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
513644|NCT00770484|E1|Reported Event|Propranolol Then Placebo|"Active treatment
Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
513645|NCT00770510|B1|Baseline|Entire Study Population|"Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first.
Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7)
A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg"
513646|NCT00770510|P1|Participant Flow|Entire Study Population|"Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first.
Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7)
A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg"
513647|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513648|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513649|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513650|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513651|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513652|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513653|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513654|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513655|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513656|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513657|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513658|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513659|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513660|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513661|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513662|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513663|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513664|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513665|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513666|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513667|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513668|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513952|NCT00771316|B2|Baseline|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
513669|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513670|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
516326|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
513671|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513672|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513673|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513674|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513675|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513676|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513677|NCT00770510|E5|Reported Event|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513678|NCT00770510|E4|Reported Event|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513679|NCT00770510|E3|Reported Event|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513680|NCT00770510|E2|Reported Event|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513681|NCT00770510|E1|Reported Event|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
513682|NCT00770562|B3|Baseline|Total|Total of all reporting groups
513683|NCT00770562|B2|Baseline|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
513684|NCT00770562|B1|Baseline|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
513685|NCT00770562|P2|Participant Flow|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (<) 20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
513686|NCT00770562|P1|Participant Flow|Arm A: Dexamethasone|Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
513687|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
513688|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
513720|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513946|NCT00771277|P1|Participant Flow|Arm 1|"Use of volunteer support teams to provide services
Support Teams: Use of volunteers organized into teams with a coordinator to provide services to TBI family"
513721|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513954|NCT00771316|P2|Participant Flow|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
513689|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
513690|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
513691|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
513692|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
513693|NCT00770562|E3|Reported Event|Salvage Therapy|Nonresponsive (failed to achieve a sustained response) participants from Arm A (dexamethasone monotherapy) who had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants from Arm B (dexamethasone + rituximab) with platelets <20 x10^9/L or with active bleeding were treated with salvage therapy of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
513694|NCT00770562|E2|Reported Event|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
513695|NCT00770562|E1|Reported Event|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4).
513696|NCT00770588|B3|Baseline|Total|Total of all reporting groups
513697|NCT00770588|B2|Baseline|Placebo|placebo 1 tablet daily
513698|NCT00770588|B1|Baseline|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
513699|NCT00770588|P2|Participant Flow|Placebo|placebo 1 tablet daily
513700|NCT00770588|P1|Participant Flow|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
513701|NCT00770588|O2|Outcome|Placebo|Placebo 1 tablet daily
513702|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
513703|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
513704|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
513705|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
513706|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
513707|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
513708|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
513709|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
513710|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
513711|NCT00770588|E2|Reported Event|Placebo|placebo 1 tablet daily
513712|NCT00770588|E1|Reported Event|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
513713|NCT00770653|B3|Baseline|Total|Total of all reporting groups
513714|NCT00770653|B2|Baseline|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513715|NCT00770653|B1|Baseline|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513716|NCT00770653|P2|Participant Flow|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513717|NCT00770653|P1|Participant Flow|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513718|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513719|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513947|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
513722|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513723|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513724|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513725|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513726|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513727|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513728|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513729|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513730|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513731|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513732|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513733|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513734|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513735|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513736|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513737|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513738|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513739|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513740|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513741|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513742|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513743|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513744|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513745|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513948|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
513949|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
513746|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513747|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513748|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513749|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513750|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513751|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513752|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513753|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513754|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513755|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513756|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513757|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513758|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513759|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513760|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513761|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513762|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513763|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513764|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513765|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513766|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513767|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513768|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513769|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513770|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513950|NCT00771277|E1|Reported Event|TBI Caregivers|Family caregivers providing support to TBI patients.
513951|NCT00771316|B3|Baseline|Total|Total of all reporting groups
513771|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513772|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513773|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513774|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513775|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513776|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513777|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513778|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513779|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513780|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513781|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513782|NCT00770653|E2|Reported Event|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
513783|NCT00770653|E1|Reported Event|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
513784|NCT00770692|B5|Baseline|Total|Total of all reporting groups
513785|NCT00770692|B4|Baseline|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513786|NCT00770692|B3|Baseline|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513787|NCT00770692|B2|Baseline|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513788|NCT00770692|B1|Baseline|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513789|NCT00770692|P4|Participant Flow|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513790|NCT00770692|P3|Participant Flow|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513791|NCT00770692|P2|Participant Flow|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513792|NCT00770692|P1|Participant Flow|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513793|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513794|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513818|NCT00770757|P1|Participant Flow|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
513819|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
513795|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513796|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513797|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513798|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513799|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513800|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513801|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513802|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513803|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513804|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513805|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513806|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513807|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513808|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513809|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513810|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513811|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513812|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513813|NCT00770692|E4|Reported Event|Eszopiclone 2 mg Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513814|NCT00770692|E3|Reported Event|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513815|NCT00770692|E2|Reported Event|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
513816|NCT00770692|E1|Reported Event|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
513817|NCT00770757|B1|Baseline|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
513820|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
513821|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
513822|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
513823|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
513824|NCT00770757|E1|Reported Event|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
513825|NCT00770770|B3|Baseline|Total|Total of all reporting groups
513826|NCT00770770|B2|Baseline|Fluocinolone Acetonide 0.5 µg/Day|"0.5 µg/day
Fluocinolone Acetonide: 0.5 µg/day"
513827|NCT00770770|B1|Baseline|Fluocinolone Acetonide 0.2 µg/Day|"0.2 µg/day
Fluocinolone Acetonide: 0.2 µg/day"
513828|NCT00770770|P2|Participant Flow|Fluocinolone Acetonide: 0.5 µg/Day|Fluocinolone Acetonide: 0.5 µg/day
513829|NCT00770770|P1|Participant Flow|Fluocinolone Acetonide: 0.2 µg/Day|Fluocinolone Acetonide: 0.2 µg/day
513830|NCT00770770|O2|Outcome|Fluocinolone Acetonide 0.5 µg/Day|"0.5 µg/day
Fluocinolone Acetonide: 0.5 µg/day"
513831|NCT00770770|O1|Outcome|Fluocinolone Acetonide 0.2 µg/Day|"0.2 µg/day
Fluocinolone Acetonide: 0.2 µg/day"
513832|NCT00770770|E2|Reported Event|Fluocinolone Acetonide: 0.5 µg/Day|Fluocinolone Acetonide: 0.5 µg/day
513833|NCT00770770|E1|Reported Event|Fluocinolone Acetonide: 0.2 µg/Day|Fluocinolone Acetonide: 0.2 µg/day
513834|NCT00770809|B4|Baseline|Total|Total of all reporting groups
513835|NCT00770809|B3|Baseline|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
513836|NCT00770809|B2|Baseline|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
513837|NCT00770809|B1|Baseline|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
513838|NCT00770809|P3|Participant Flow|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
513839|NCT00770809|P2|Participant Flow|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
513840|NCT00770809|P1|Participant Flow|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
513841|NCT00770809|O3|Outcome|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
513842|NCT00770809|O2|Outcome|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
513843|NCT00770809|O1|Outcome|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
513844|NCT00770809|E3|Reported Event|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
513845|NCT00770809|E2|Reported Event|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
513846|NCT00770809|E1|Reported Event|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
513847|NCT00770861|B3|Baseline|Total|Total of all reporting groups
513848|NCT00770861|B2|Baseline|Placebo|Matching placebo tablets, oral administration
513849|NCT00770861|B1|Baseline|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
513850|NCT00770861|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
513851|NCT00770861|P1|Participant Flow|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
513852|NCT00770861|O2|Outcome|Placebo|Matching placebo tablets, oral administration
513908|NCT00770991|O1|Outcome|Lyophilized Black Raspberry (BRB) Suppositories Plus Placebo|Two, 730 mg BRB suppositories administered at bedtime plus 20 grams placebo slurry .
513853|NCT00770861|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
513855|NCT00770861|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
513856|NCT00770861|E2|Reported Event|Placebo|Matching placebo tablets, oral administration
513857|NCT00770861|E1|Reported Event|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
513858|NCT00770913|B4|Baseline|Total|Total of all reporting groups
513859|NCT00770913|B3|Baseline|E3810 20 mg Twice Daily|E3810 20mg twice daily orally for 8 weeks
513860|NCT00770913|B2|Baseline|E3810 10 mg Twice Daily|E3810 10mg twice daily orally for 8 weeks
513861|NCT00770913|B1|Baseline|E3810 20 mg Once Daily|E3810 20mg once daily orally for 8 weeks
513862|NCT00770913|P3|Participant Flow|E3810 20 mg Twice Daily|E3810 20mg twice daily orally for 8 weeks
513863|NCT00770913|P2|Participant Flow|E3810 10 mg Twice Daily|E3810 10mg twice daily orally for 8 weeks
513864|NCT00770913|P1|Participant Flow|E3810 20 mg Once Daily|E3810 20mg once daily orally for 8 weeks
513865|NCT00770913|O3|Outcome|E3810 20 mg|E3810 20 mg twice daily orally for 8 weeks
513866|NCT00770913|O2|Outcome|E3810 10 mg Twice Daily|E3810 10 mg twice daily orally for 8 weeks
513867|NCT00770913|O1|Outcome|E3810 20 mg Once Daily|E3810 20 mg once daily orally for 8 weeks
513868|NCT00770913|E3|Reported Event|E3810 20 mg|E3810 20 mg twice daily orally for 8 weeks
513869|NCT00770913|E2|Reported Event|E3810 10 mg Twice Daily|E3810 10 mg twice daily orally for 8 weeks
513870|NCT00770913|E1|Reported Event|E3810 20 mg Once Daily|E3810 20 mg once daily orally for 8 weeks
513871|NCT00770965|B5|Baseline|Total|Total of all reporting groups
513872|NCT00770965|B4|Baseline|Placebo|Participants received placebo to AIN457A IV on day 1.
513873|NCT00770965|B3|Baseline|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
513874|NCT00770965|B2|Baseline|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
513875|NCT00770965|B1|Baseline|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
513876|NCT00770965|P4|Participant Flow|Placebo|Participants received placebo to AIN457A IV on day 1.
513877|NCT00770965|P3|Participant Flow|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
513878|NCT00770965|P2|Participant Flow|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
513879|NCT00770965|P1|Participant Flow|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
513880|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
513881|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
513882|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
513883|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
513884|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
513885|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
513886|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
513887|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
513888|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
513889|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
513890|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
513891|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
513892|NCT00770965|E4|Reported Event|Placebo|Placebo
513893|NCT00770965|E3|Reported Event|AIN457 3 mg/kg|AIN457 3 mg/kg
513894|NCT00770965|E2|Reported Event|AIN457 1 mg/kg|AIN457 1 mg/kg
513895|NCT00770965|E1|Reported Event|AIN457 0.3 mg/kg|AIN457 0.3 mg/kg
513896|NCT00770991|B3|Baseline|Total|Total of all reporting groups
513897|NCT00770991|B2|Baseline|Two Berry Suppositories Bedtime Plus Placebo Powder|20 g of placebo powder administered as an oral slurry 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
513898|NCT00770991|B1|Baseline|Two Berry Suppositories Bedtime Plus Oral Berry Powder|20 g of lyophilized berry powder administered orally 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
513899|NCT00770991|P2|Participant Flow|Black Raspberry Slurry Plus 2 Berry Suppositories|20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
513900|NCT00770991|P1|Participant Flow|Placebo Powder Plus 2 Berry Suppositories|20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
513901|NCT00770991|O3|Outcome|All Participants|
513902|NCT00770991|O2|Outcome|Lyophilized BRB Suppositories + BRB Slurry|
513903|NCT00770991|O1|Outcome|Lyophilized Black Raspberry (BRB) Suppositories + Placebo|Two, 730 mg BRB suppositories administered at bedtime.
513904|NCT00770991|O2|Outcome|Polyp|all participants used for this analysis
513905|NCT00770991|O1|Outcome|Normal Mucosa|all participants combined for this analysis. Sample of normal mucosa
513906|NCT00770991|O3|Outcome|All Participants|
513907|NCT00770991|O2|Outcome|Lypholized BRB Suppositiry Plus BRB Slurry|2 lyphilized black raspberry suppositories plus black raspberry slurry.
513909|NCT00770991|E2|Reported Event|Black Raspberry Slurry Plus 2 Berry Suppositories|20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
514288|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
513910|NCT00770991|E1|Reported Event|Black Raspberry Placebo Slurry Plus 2 Berry Suppositories|20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
513911|NCT00771056|B1|Baseline|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
513912|NCT00771056|P1|Participant Flow|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
513913|NCT00771056|O1|Outcome|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
513914|NCT00771056|O1|Outcome|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
513915|NCT00771056|E1|Reported Event|Hydroxychloroquine|"Hydroxychloroquine 400 mg po daily for up to one year.
Hydroxychloroquine: 400mg by mouth daily x 1 year"
513916|NCT00771173|B3|Baseline|Total|Total of all reporting groups
513917|NCT00771173|B2|Baseline|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.
Placebo: Placebo tablet administered q8 hours for 24 hours postop."
513918|NCT00771173|B1|Baseline|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first
phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
513919|NCT00771173|P2|Participant Flow|Active Agent Group|Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first
513920|NCT00771173|P1|Participant Flow|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.
Blinding: The research pharmacist has facilitated the blinding by placing the active agent (200 mg tablets) into a solid colored capsule. She will make matching placebo capsules filled with lactose powder. To aid in blinding and avoid systemic administration of other dye agents for women in the placebo group, a small amount of orange dye will be placed in the Foley bag. This has been tested in the planning for this trial and is known effectively color the urine orange."
513921|NCT00771173|O2|Outcome|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.
Placebo: Placebo tablet administered q8 hours for 24 hours postop."
513922|NCT00771173|O1|Outcome|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first
phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
513923|NCT00771173|E2|Reported Event|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.
Placebo: Placebo tablet administered q8 hours for 24 hours postop."
513924|NCT00771173|E1|Reported Event|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first
phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
513925|NCT00771238|B3|Baseline|Total|Total of all reporting groups
513926|NCT00771238|B2|Baseline|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
513927|NCT00771238|B1|Baseline|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care
Total Care P500 Mattress: Study mattress"
513928|NCT00771238|P2|Participant Flow|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
513929|NCT00771238|P1|Participant Flow|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care
Total Care P500 Mattress: Study mattress"
513930|NCT00771238|O2|Outcome|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
513931|NCT00771238|O1|Outcome|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care
Total Care P500 Mattress: Study mattress"
513932|NCT00771238|O2|Outcome|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
513933|NCT00771238|O1|Outcome|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care
Total Care P500 Mattress: Study mattress"
513934|NCT00771238|E2|Reported Event|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
513935|NCT00771238|E1|Reported Event|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care
Total Care P500 Mattress: Study mattress"
513936|NCT00771264|B3|Baseline|Total|Total of all reporting groups
513937|NCT00771264|B2|Baseline|Sham / Placebo|
513938|NCT00771264|B1|Baseline|Urgent PC|
513939|NCT00771264|P2|Participant Flow|Sham / Placebo|
513940|NCT00771264|P1|Participant Flow|Urgent PC|
513941|NCT00771264|O2|Outcome|Sham / Placebo|
513942|NCT00771264|O1|Outcome|Urgent PC|
513943|NCT00771264|E2|Reported Event|Sham / Placebo|
513944|NCT00771264|E1|Reported Event|Urgent PC|
513953|NCT00771316|B1|Baseline|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
513955|NCT00771316|P1|Participant Flow|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
513956|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
513957|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
513958|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
513959|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
513960|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
513961|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
513962|NCT00771316|E2|Reported Event|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
513963|NCT00771316|E1|Reported Event|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
513964|NCT00771407|B3|Baseline|Total|Total of all reporting groups
513965|NCT00771407|B2|Baseline|Standard Ostomy Construction|Ostomy created in the standard fashion
513966|NCT00771407|B1|Baseline|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
513967|NCT00771407|P2|Participant Flow|Standard Ostomy Construction|Ostomy created in the standard fashion
513968|NCT00771407|P1|Participant Flow|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
513969|NCT00771407|O2|Outcome|Standard Ostomy Construction|Ostomy will be created in the standard fashion
513970|NCT00771407|O1|Outcome|Strattice Fascial Inlay|Strattice will be placed as a fascial inlay to support the ostomy site
513971|NCT00771407|E2|Reported Event|Standard Ostomy Construction|Ostomy created in the standard fashion
513972|NCT00771407|E1|Reported Event|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
513973|NCT00771472|B1|Baseline|Vorinostat|Parts I & II: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
513974|NCT00771472|P2|Participant Flow|Part II|Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle.
513975|NCT00771472|P1|Participant Flow|Part I|Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle.
513976|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
513977|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
513978|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
513979|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
513980|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
513981|NCT00771472|O1|Outcome|Vorinostat|Parts I & II: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
513982|NCT00771472|E1|Reported Event|Vorinostat|Parts I & II: vorinostat(400 mg) Oral, daily (QD). Treatment period was 28 days per cycle.
513983|NCT00771537|B17|Baseline|Total|Total of all reporting groups
513984|NCT00771537|B16|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
513985|NCT00771537|B15|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
513986|NCT00771537|B14|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
513987|NCT00771537|B13|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
513988|NCT00771537|B12|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
513989|NCT00771537|B11|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
513990|NCT00771537|B10|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
513991|NCT00771537|B9|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
513992|NCT00771537|B8|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
513993|NCT00771537|B7|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
514289|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
513994|NCT00771537|B6|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
513995|NCT00771537|B5|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
513996|NCT00771537|B4|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
513997|NCT00771537|B3|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
513998|NCT00771537|B2|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
513999|NCT00771537|B1|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514000|NCT00771537|P16|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
514001|NCT00771537|P15|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
514002|NCT00771537|P14|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
514003|NCT00771537|P13|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514004|NCT00771537|P12|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
514005|NCT00771537|P11|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
514006|NCT00771537|P10|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
514007|NCT00771537|P9|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514008|NCT00771537|P8|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
514009|NCT00771537|P7|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
514010|NCT00771537|P6|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
514011|NCT00771537|P5|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514012|NCT00771537|P4|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
514013|NCT00771537|P3|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
514014|NCT00771537|P2|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
514015|NCT00771537|P1|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514016|NCT00771537|O4|Outcome|2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
514017|NCT00771537|O3|Outcome|2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
514018|NCT00771537|O2|Outcome|1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
514019|NCT00771537|O1|Outcome|Control/Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514385|NCT00771758|O6|Outcome|Baseline Total|Tapentadol IR
514020|NCT00771537|O4|Outcome|2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514021|NCT00771537|O3|Outcome|2-Sided Trivial|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514022|NCT00771537|O2|Outcome|1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514023|NCT00771537|O1|Outcome|Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514024|NCT00771537|E16|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
514025|NCT00771537|E15|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
514026|NCT00771537|E14|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
514027|NCT00771537|E13|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514028|NCT00771537|E12|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
514029|NCT00771537|E11|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
514030|NCT00771537|E10|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
514031|NCT00771537|E9|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514032|NCT00771537|E8|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
514033|NCT00771537|E7|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
514034|NCT00771537|E6|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
514035|NCT00771537|E5|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514036|NCT00771537|E4|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
514037|NCT00771537|E3|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
514038|NCT00771537|E2|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
514039|NCT00771537|E1|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
514040|NCT00771602|B4|Baseline|Total|Total of all reporting groups
514041|NCT00771602|B3|Baseline|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
514042|NCT00771602|B2|Baseline|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
514043|NCT00771602|B1|Baseline|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
514044|NCT00771602|P3|Participant Flow|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
514045|NCT00771602|P2|Participant Flow|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
514046|NCT00771602|P1|Participant Flow|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
514047|NCT00771602|O3|Outcome|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
514048|NCT00771602|O2|Outcome|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
514049|NCT00771602|O1|Outcome|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
514050|NCT00771602|E3|Reported Event|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
514051|NCT00771602|E2|Reported Event|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
514052|NCT00771602|E1|Reported Event|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
514053|NCT00771615|B10|Baseline|Total|Total of all reporting groups
514262|NCT00771667|B4|Baseline|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
514263|NCT00771667|B3|Baseline|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
514386|NCT00771758|O5|Outcome|Missing - End of Study|Tapentadol IR
514290|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
514291|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
514054|NCT00771615|B9|Baseline|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514055|NCT00771615|B8|Baseline|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514056|NCT00771615|B7|Baseline|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514057|NCT00771615|B6|Baseline|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514058|NCT00771615|B5|Baseline|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514059|NCT00771615|B4|Baseline|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514060|NCT00771615|B3|Baseline|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514061|NCT00771615|B2|Baseline|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514062|NCT00771615|B1|Baseline|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514063|NCT00771615|P9|Participant Flow|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514064|NCT00771615|P8|Participant Flow|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514065|NCT00771615|P7|Participant Flow|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514066|NCT00771615|P6|Participant Flow|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514067|NCT00771615|P5|Participant Flow|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514068|NCT00771615|P4|Participant Flow|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514069|NCT00771615|P3|Participant Flow|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514070|NCT00771615|P2|Participant Flow|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514071|NCT00771615|P1|Participant Flow|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514387|NCT00771758|O4|Outcome|Poor - End of Study|Tapentadol IR
514072|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514073|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514074|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514075|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514076|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514077|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514078|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514079|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514080|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514081|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514082|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514083|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514084|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514085|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514086|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514087|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514088|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514089|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514264|NCT00771667|B2|Baseline|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
514265|NCT00771667|B1|Baseline|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
514090|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514091|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514092|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514093|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514094|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514095|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514096|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514097|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514098|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514099|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514100|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514101|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514102|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514103|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514104|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514105|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514106|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514107|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514266|NCT00771667|P10|Participant Flow|Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
514108|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514109|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514110|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514111|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514112|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514113|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514114|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514115|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514116|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514117|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514118|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514119|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514120|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514121|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514267|NCT00771667|P9|Participant Flow|Ustekinumab IV -> Nonresponder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
514268|NCT00771667|P8|Participant Flow|Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
514122|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514123|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514124|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514125|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514126|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514127|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514128|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514129|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514130|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514131|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514132|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514269|NCT00771667|P7|Participant Flow|Ustekinumab IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
514286|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
514133|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514134|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514135|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514136|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514137|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514138|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514139|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514140|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514141|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514142|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514143|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514144|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514145|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514146|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514147|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514148|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514149|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514150|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514151|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514152|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514153|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514154|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514155|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514270|NCT00771667|P6|Participant Flow|Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
514287|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
514156|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514157|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514158|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514159|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514160|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514161|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514162|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514163|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514164|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514165|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514166|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514271|NCT00771667|P5|Participant Flow|Placebo IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
514272|NCT00771667|P4|Participant Flow|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
514167|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514168|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514169|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514170|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514171|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514172|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514173|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514174|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514175|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514176|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514177|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514273|NCT00771667|P3|Participant Flow|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
514274|NCT00771667|P2|Participant Flow|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
514378|NCT00771758|O1|Outcome|Excellent - End of Study|Placebo
514178|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514179|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514180|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514181|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514182|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514183|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514184|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514185|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514186|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514187|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514188|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514189|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514190|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514191|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514192|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514193|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514194|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514195|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514196|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514197|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514198|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514199|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514200|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514275|NCT00771667|P1|Participant Flow|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
514276|NCT00771667|O2|Outcome|Ustekinumab 90 mg SC|As a single subcutaneous dose at Weeks 8 and 16
514277|NCT00771667|O1|Outcome|Placebo SC|As a single subcutaneous dose at Weeks 8 and 16
514201|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514202|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514203|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514204|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514205|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514206|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514207|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514208|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514209|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514210|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514211|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514278|NCT00771667|O2|Outcome|Ustekinumab 90 mg SC|As a single subcutaneous dose at Weeks 8 and 16
514279|NCT00771667|O1|Outcome|Placebo SC|As a single subcutaneous dose at Weeks 8 and 16
514280|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
514212|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514213|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514214|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514215|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514216|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514217|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514218|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514219|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514220|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514221|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514222|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514281|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
514282|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
514283|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
514223|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514224|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514225|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514226|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514227|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514228|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514229|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514230|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514231|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514232|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514233|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514234|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514235|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514236|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514237|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514238|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514239|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514240|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514241|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514242|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514243|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514244|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514245|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514284|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
514285|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
514379|NCT00771758|O6|Outcome|Baseline Total|Oxycodone IR
514246|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514247|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514248|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514249|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514250|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.
The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
514251|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514252|NCT00771615|E9|Reported Event|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514253|NCT00771615|E8|Reported Event|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514254|NCT00771615|E7|Reported Event|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514255|NCT00771615|E6|Reported Event|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514256|NCT00771615|E5|Reported Event|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514257|NCT00771615|E4|Reported Event|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514258|NCT00771615|E3|Reported Event|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514259|NCT00771615|E2|Reported Event|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514260|NCT00771615|E1|Reported Event|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514261|NCT00771667|B5|Baseline|Total|Total of all reporting groups
514292|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
514293|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
514294|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
514295|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
514296|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
514297|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
514298|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
514299|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
514300|NCT00771667|E10|Reported Event|Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
514301|NCT00771667|E9|Reported Event|Ustekinumab IV -> Nonresponder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
514302|NCT00771667|E8|Reported Event|Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
514303|NCT00771667|E7|Reported Event|Ustekinumab IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
514304|NCT00771667|E6|Reported Event|Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
514305|NCT00771667|E5|Reported Event|Placebo IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
514306|NCT00771667|E4|Reported Event|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
514307|NCT00771667|E3|Reported Event|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
514308|NCT00771667|E2|Reported Event|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
514309|NCT00771667|E1|Reported Event|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
514310|NCT00771745|B3|Baseline|Total|Total of all reporting groups
514311|NCT00771745|B2|Baseline|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
514312|NCT00771745|B1|Baseline|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF
anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
514313|NCT00771745|P2|Participant Flow|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
514314|NCT00771745|P1|Participant Flow|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF
anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
514315|NCT00771745|O2|Outcome|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
514316|NCT00771745|O1|Outcome|Preloading Induction With Thymoglobulin x 4 Doses|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF
anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
514317|NCT00771745|E2|Reported Event|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
514318|NCT00771745|E1|Reported Event|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF
anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
514319|NCT00771758|B4|Baseline|Total|Total of all reporting groups
514320|NCT00771758|B3|Baseline|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514321|NCT00771758|B2|Baseline|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514380|NCT00771758|O5|Outcome|Missing - End of Study|Oxycodone IR
514322|NCT00771758|B1|Baseline|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514323|NCT00771758|P3|Participant Flow|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514324|NCT00771758|P2|Participant Flow|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
516327|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
514325|NCT00771758|P1|Participant Flow|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514326|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514327|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514328|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514329|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514330|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514331|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514332|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514333|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514334|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514335|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514336|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514337|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514338|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514339|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514340|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514341|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514342|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514343|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514344|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514345|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514346|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514347|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514348|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514349|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514350|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514351|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514352|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514353|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514354|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514355|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514356|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514357|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514358|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514359|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514360|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514361|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514362|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514363|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514364|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514365|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514366|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514367|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514368|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514369|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514370|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514371|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514372|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514373|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514374|NCT00771758|O5|Outcome|Baseline Total|Placebo
514375|NCT00771758|O4|Outcome|Poor - End of Study|Placebo
514376|NCT00771758|O3|Outcome|Fair - End of Study|Placebo
514377|NCT00771758|O2|Outcome|Good - End of Study|Placebo
514388|NCT00771758|O3|Outcome|Fair - End of Study|Tapentadol IR
514389|NCT00771758|O2|Outcome|Good - End of Study|Tapentadol IR
514390|NCT00771758|O1|Outcome|Excellent - End of Study|Tapentadol IR
514391|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
516328|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
514392|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514393|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514394|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514395|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514396|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514397|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514398|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514399|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514400|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514401|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514402|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514403|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514404|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514405|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514406|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514407|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514408|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514409|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514410|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514411|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514412|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514413|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514414|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514415|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514416|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514417|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514418|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514419|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514420|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514421|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514422|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514423|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514424|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514425|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514426|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514427|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514428|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514429|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514430|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514431|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514432|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514433|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514434|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514435|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514436|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514437|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514438|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514439|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514440|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514441|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514442|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514443|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514444|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514445|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514446|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514447|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514448|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514449|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514450|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514451|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514452|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514453|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514454|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514455|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514456|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514457|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514458|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514459|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514460|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514461|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514462|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514463|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514464|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514465|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514466|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514467|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514468|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514469|NCT00771758|E3|Reported Event|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
514470|NCT00771758|E2|Reported Event|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
514471|NCT00771758|E1|Reported Event|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
514472|NCT00771810|B4|Baseline|Total|Total of all reporting groups
514473|NCT00771810|B3|Baseline|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514474|NCT00771810|B2|Baseline|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514475|NCT00771810|B1|Baseline|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514476|NCT00771810|P3|Participant Flow|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514477|NCT00771810|P2|Participant Flow|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514478|NCT00771810|P1|Participant Flow|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514479|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514480|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514481|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514482|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514483|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514484|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514485|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514486|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514487|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514488|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514489|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514490|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514491|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514492|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514493|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514494|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514495|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514496|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514497|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514498|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514499|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514500|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514501|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514502|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514503|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514504|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514505|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514506|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514507|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514508|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514509|NCT00771810|E3|Reported Event|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
514510|NCT00771810|E2|Reported Event|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
514511|NCT00771810|E1|Reported Event|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
514512|NCT00771849|B3|Baseline|Total|Total of all reporting groups
514513|NCT00771849|B2|Baseline|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
514514|NCT00771849|B1|Baseline|Menactra® Vaccine Group|Participants received Menactra® Vaccine
514515|NCT00771849|P2|Participant Flow|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
514516|NCT00771849|P1|Participant Flow|Menactra® Vaccine Group|Participants received Menactra® Vaccine
514517|NCT00771849|O2|Outcome|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
514518|NCT00771849|O1|Outcome|Menactra® Vaccine Group|Participants received Menactra® Vaccine
514519|NCT00771849|O2|Outcome|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
514520|NCT00771849|O1|Outcome|Menactra® Vaccine Group|Participants received Menactra® Vaccine
514521|NCT00771849|E2|Reported Event|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
514522|NCT00771849|E1|Reported Event|Menactra® Vaccine Group|Participants received Menactra® Vaccine
514523|NCT00771875|B4|Baseline|Total|Total of all reporting groups
514524|NCT00771875|B3|Baseline|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514525|NCT00771875|B2|Baseline|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
514526|NCT00771875|B1|Baseline|Rabbit Antithymocyte Globulin (RATG)|"RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514527|NCT00771875|P3|Participant Flow|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514528|NCT00771875|P2|Participant Flow|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
514529|NCT00771875|P1|Participant Flow|Rabbit Antithymocyte Globulin (RATG)|"RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on cluster of differentiation 3 (CD3) count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via intravenous push (IVP) over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514530|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514531|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
514583|NCT00771953|B2|Baseline|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
514549|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
514585|NCT00771953|P2|Participant Flow|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
514532|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514533|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514534|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
514535|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514536|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514537|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
514538|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514539|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514540|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
514541|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514542|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514543|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
514544|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514545|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514546|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
514547|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514548|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514550|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514551|NCT00771875|E3|Reported Event|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514552|NCT00771875|E2|Reported Event|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
514553|NCT00771875|E1|Reported Event|Rabbit Antithymocyte Globulin (RATG)|"RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
514554|NCT00771914|B5|Baseline|Total|Total of all reporting groups
514555|NCT00771914|B4|Baseline|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin
514556|NCT00771914|B3|Baseline|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin
514557|NCT00771914|B2|Baseline|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
514558|NCT00771914|B1|Baseline|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
514559|NCT00771914|P4|Participant Flow|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
514560|NCT00771914|P3|Participant Flow|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81 mg of Aspirin
514561|NCT00771914|P2|Participant Flow|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza, then 4 grams of Lovaza, then 81mg of Aspirin
514562|NCT00771914|P1|Participant Flow|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
514563|NCT00771914|O4|Outcome|Both Aspirin and Lovaza|All participants received Aspirin and Lovaza intervention regardless of sequence.
514564|NCT00771914|O3|Outcome|Lovaza|All participants received Lovaza intervention regardless of sequence.
514565|NCT00771914|O2|Outcome|Aspirin|All participants received Aspirin intervention regardless of sequence.
514566|NCT00771914|O1|Outcome|Placebo|All participants received Placebo intervention regardless of sequence.
514567|NCT00771914|E4|Reported Event|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin
514568|NCT00771914|E3|Reported Event|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin
514569|NCT00771914|E2|Reported Event|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
514570|NCT00771914|E1|Reported Event|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
514571|NCT00771927|B3|Baseline|Total|Total of all reporting groups
514572|NCT00771927|B2|Baseline|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
514573|NCT00771927|B1|Baseline|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
514574|NCT00771927|P2|Participant Flow|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
514575|NCT00771927|P1|Participant Flow|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
514576|NCT00771927|O2|Outcome|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
514577|NCT00771927|O1|Outcome|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
514578|NCT00771927|O2|Outcome|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
514579|NCT00771927|O1|Outcome|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
514580|NCT00771927|E2|Reported Event|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
514581|NCT00771927|E1|Reported Event|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
514582|NCT00771953|B3|Baseline|Total|Total of all reporting groups
514584|NCT00771953|B1|Baseline|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
515782|NCT00765076|B3|Baseline|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
514586|NCT00771953|P1|Participant Flow|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
514587|NCT00771953|O4|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed 500mg/m2 q21 days
514588|NCT00771953|O3|Outcome|Apricoxib Plus Pemetrexed|Apricoxib 400mg qd plus pemetrexed 500mg/m2 q21 days
514589|NCT00771953|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel 75mg/m2 q21 days
514590|NCT00771953|O1|Outcome|Apricoxib Plus Docetaxel|Apricoxib 400mg qd plus docetaxel 75mg/m2 q21 days
514591|NCT00771953|E2|Reported Event|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
514592|NCT00771953|E1|Reported Event|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
514593|NCT00772005|B5|Baseline|Total|Total of all reporting groups
514594|NCT00772005|B4|Baseline|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514595|NCT00772005|B3|Baseline|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514596|NCT00772005|B2|Baseline|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514597|NCT00772005|B1|Baseline|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514598|NCT00772005|P4|Participant Flow|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514599|NCT00772005|P3|Participant Flow|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514600|NCT00772005|P2|Participant Flow|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514601|NCT00772005|P1|Participant Flow|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514602|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515333|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
515334|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
516512|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
515518|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
514603|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514604|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514605|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514606|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514607|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514608|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514609|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514610|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514611|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514612|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514613|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515335|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
515336|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
515337|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
522745|NCT00795184|O4|Outcome|HDWLE+NBI+pCLE|
514614|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514615|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514616|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514617|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514618|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514619|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514620|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514621|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514622|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514623|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514624|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515338|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
515339|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
515340|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
522746|NCT00795184|O3|Outcome|pCLE|
514625|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514626|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514627|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514628|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514629|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514630|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514631|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514632|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514633|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514634|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514635|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515341|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
515342|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
515343|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
516513|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
514636|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514637|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514638|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514639|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514640|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514641|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514642|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514643|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514644|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514645|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514646|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515344|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
515345|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
515346|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
516514|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
514647|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514648|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514649|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514650|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514651|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514652|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514653|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514654|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514655|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514656|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514657|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515347|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
515348|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
515349|NCT00772109|E4|Reported Event|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
522747|NCT00795184|O2|Outcome|NBI (Narrow Band Imaging)|
514658|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514659|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514660|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514661|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514662|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514663|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514664|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514665|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514666|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514667|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514668|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515350|NCT00772109|E3|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
515351|NCT00772109|E2|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
515352|NCT00772109|E1|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
515353|NCT00772148|B3|Baseline|Total|Total of all reporting groups
514669|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514670|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514671|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514672|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514673|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514674|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514675|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514676|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514677|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514678|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514679|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515354|NCT00772148|B2|Baseline|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
516130|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
514680|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514681|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514682|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514683|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514684|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514685|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514686|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514687|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514688|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514689|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514690|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515355|NCT00772148|B1|Baseline|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
522748|NCT00795184|O1|Outcome|HDWLE|
514691|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514692|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514693|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514694|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514695|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514696|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514697|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514698|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514699|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514700|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514701|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515356|NCT00772148|P2|Participant Flow|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
516131|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
514702|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514703|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514704|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514705|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514706|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514707|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514708|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514709|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514710|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514711|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514712|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515357|NCT00772148|P1|Participant Flow|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
522749|NCT00795184|E1|Reported Event|Group 1|NBI-pCLE or pCLE-NBI
514713|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514714|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514715|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514716|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514717|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514718|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514719|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514720|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514721|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514722|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514723|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515358|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
516132|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
514724|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514725|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514726|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514727|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514728|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514729|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514730|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514731|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514732|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514733|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514734|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515359|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
522750|NCT00795210|B4|Baseline|Total|Total of all reporting groups
514735|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514736|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514737|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514738|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514739|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514740|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514741|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514742|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514743|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514744|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514745|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515360|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
516133|NCT00765882|E3|Reported Event|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
514746|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514747|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514748|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514749|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514750|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514751|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514752|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514753|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514754|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514755|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514756|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515361|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
523179|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
514757|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514758|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514759|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514760|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514761|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514762|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514763|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514764|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514765|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514766|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514767|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515362|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
516134|NCT00765882|E2|Reported Event|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
514768|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514769|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514770|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514771|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514772|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514773|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514774|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514775|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514776|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514777|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514778|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515363|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
523180|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
514779|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514780|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514781|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514782|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514783|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514784|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514785|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514786|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514787|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514788|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514789|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515364|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
516135|NCT00765882|E1|Reported Event|Placebo|Dose matched placebo, oral administration, once per day.
514790|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514791|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514792|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514793|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514794|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514795|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514796|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514797|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514798|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514799|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514800|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515365|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
516136|NCT00765895|B3|Baseline|Total|Total of all reporting groups
514801|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514802|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514803|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514804|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514805|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514806|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514807|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514808|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514809|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514810|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514811|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515366|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
516278|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
516279|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
514812|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514813|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514814|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514815|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514816|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514817|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514818|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514819|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514820|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514821|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514822|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515367|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
516280|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
514823|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514824|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514825|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514826|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514827|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514828|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514829|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514830|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514831|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514832|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514833|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515368|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
516281|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
516282|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
514834|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514835|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514836|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514837|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514838|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514839|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514840|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514841|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514842|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514843|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514844|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515369|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
516283|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
514845|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514846|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514847|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514848|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514849|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514850|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514851|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514852|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514853|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514854|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514855|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515370|NCT00772148|E2|Reported Event|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
516284|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
516285|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
514856|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514857|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514858|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514859|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514860|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514861|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514862|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514863|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514864|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514865|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514866|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515371|NCT00772148|E1|Reported Event|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
516286|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
514867|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514868|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514869|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514870|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514871|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514872|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514873|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514874|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514875|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514876|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514877|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515372|NCT00772304|B1|Baseline|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
515373|NCT00772304|P1|Participant Flow|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
515374|NCT00772304|O1|Outcome|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
515375|NCT00772304|E1|Reported Event|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
516287|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
514878|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514879|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514880|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514881|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514882|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514883|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514884|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514885|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514886|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514887|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514888|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515376|NCT00772369|B1|Baseline|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
515377|NCT00772369|P1|Participant Flow|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
515378|NCT00772369|O1|Outcome|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
515379|NCT00772369|O1|Outcome|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
516288|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
514889|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514890|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514891|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514892|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514893|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514894|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514895|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514896|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514897|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514898|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514899|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515380|NCT00772369|E1|Reported Event|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
515381|NCT00772382|B1|Baseline|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
515382|NCT00772382|P1|Participant Flow|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
515383|NCT00772382|O1|Outcome|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
515384|NCT00772382|O1|Outcome|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
514900|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514901|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514902|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514903|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514904|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514905|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514906|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514907|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514908|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514909|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514910|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515385|NCT00772382|E1|Reported Event|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
515386|NCT00772447|B3|Baseline|Total|Total of all reporting groups
515387|NCT00772447|B2|Baseline|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515388|NCT00772447|B1|Baseline|Daptomycin|daptomycin 4mg/kg iv every 24hours
516289|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
514911|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514912|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514913|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514914|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514915|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514916|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514917|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514918|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514919|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514920|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514921|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515389|NCT00772447|P2|Participant Flow|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515390|NCT00772447|P1|Participant Flow|Daptomycin|daptomycin 4mg/kg iv every 24hours
515391|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515392|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
514922|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514923|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514924|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514925|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514926|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514927|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514928|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514929|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514930|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514931|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514932|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515393|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515394|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
515395|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515396|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
514933|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514934|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514935|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514936|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514937|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514938|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514939|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514940|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514941|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514942|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514943|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515397|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515398|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
515399|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515400|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
514944|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514945|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514946|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514947|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514948|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514949|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514950|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514951|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514952|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514953|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514954|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515401|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hrs, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515402|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
515403|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515404|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
514955|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514956|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514957|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514958|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514959|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514960|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514961|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514962|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514963|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514964|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514965|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515405|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hrs, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515406|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
515407|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515408|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
514966|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514967|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514968|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514969|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514970|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514971|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514972|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514973|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514974|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514975|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514976|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515409|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515410|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
515411|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515412|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
514977|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514978|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514979|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514980|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514981|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514982|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514983|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514984|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514985|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514986|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514987|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515413|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515414|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
515415|NCT00772447|E2|Reported Event|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
515416|NCT00772447|E1|Reported Event|Daptomycin|daptomycin 4mg/kg iv every 24hours
514988|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514989|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514990|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514991|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514992|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514993|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514994|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514995|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514996|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514997|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
514998|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515417|NCT00764660|B3|Baseline|Total|Total of all reporting groups
515418|NCT00764660|B2|Baseline|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
515419|NCT00764660|B1|Baseline|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515420|NCT00764660|P2|Participant Flow|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
514999|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515000|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515001|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515002|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515003|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515004|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515005|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515006|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515007|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515008|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515009|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515421|NCT00764660|P1|Participant Flow|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515422|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
515423|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
516290|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515010|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515011|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515012|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515013|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515014|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515015|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515016|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515017|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515018|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515019|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515020|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515424|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
515425|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515426|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
516291|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
516292|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515021|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515022|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515023|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515024|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515025|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515026|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515027|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515028|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515029|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515030|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515031|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515427|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515428|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
515429|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
516293|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
515032|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515033|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515034|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515035|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515036|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515037|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515038|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515039|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515040|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515041|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515042|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515430|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
515431|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515432|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
516294|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
516295|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
515043|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515044|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515045|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515046|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515047|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515048|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515049|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515050|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515051|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515052|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515053|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515433|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515434|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
515435|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
516296|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515054|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515055|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515056|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515057|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515058|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515059|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515060|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515061|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515062|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515063|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515064|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515436|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
515437|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515438|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
516297|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
516298|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515065|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515066|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515067|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515068|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515069|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515070|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515071|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515072|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515073|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515074|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515075|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515439|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515440|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
515441|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
516299|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
515076|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515077|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515078|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515079|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515080|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515081|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515082|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515083|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515084|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515085|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515086|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515442|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
515443|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515444|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
516300|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
516301|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
515087|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515088|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515089|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515090|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515091|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515092|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515093|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515094|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515095|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515096|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515097|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515445|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515446|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
515447|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
516302|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515098|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515099|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515100|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515101|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515102|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515103|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515104|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515105|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515106|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515107|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515108|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515448|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
515449|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515450|NCT00764660|E2|Reported Event|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
516303|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
516304|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515109|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515110|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515111|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515112|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515113|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515114|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515115|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515116|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515117|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515118|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515119|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515451|NCT00764660|E1|Reported Event|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
515452|NCT00764673|B1|Baseline|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
515453|NCT00764673|P1|Participant Flow|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
515120|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515121|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515122|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515123|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515124|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515125|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515126|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515127|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515128|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515129|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515130|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515454|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
515455|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
515456|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
516305|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
515131|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515132|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515133|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515134|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515135|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515136|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515137|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515138|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515139|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515140|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515141|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515457|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
515458|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
515459|NCT00764673|E1|Reported Event|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
515142|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515143|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515144|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515145|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515146|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515147|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515148|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515149|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515150|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515151|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515152|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515460|NCT00764790|B4|Baseline|Total|Total of all reporting groups
515461|NCT00764790|B3|Baseline|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
516306|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515153|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515154|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515155|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515156|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515157|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515158|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515159|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515160|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515161|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515162|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515163|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515462|NCT00764790|B2|Baseline|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515962|NCT00765570|B1|Baseline|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
515164|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515165|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515166|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515167|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515168|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515169|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515170|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515171|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515172|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515173|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515174|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515463|NCT00764790|B1|Baseline|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515773|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515175|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515176|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515177|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515178|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515179|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515180|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515181|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515182|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515183|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515184|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515185|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515464|NCT00764790|P3|Participant Flow|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515774|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515186|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515187|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515188|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515189|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515190|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515191|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515192|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515193|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515194|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515195|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515196|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515465|NCT00764790|P2|Participant Flow|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515963|NCT00765570|P2|Participant Flow|Treatment Group-2|Treatment Group 2:15 treatments with standard radiation
515197|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515198|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515199|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515200|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515201|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515202|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515203|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515204|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515205|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515206|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515207|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515466|NCT00764790|P1|Participant Flow|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515775|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515208|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515209|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515210|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515211|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515212|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515213|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515214|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515215|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515216|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515217|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515218|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515467|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515776|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515219|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515220|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515221|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515222|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515223|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515224|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515225|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515226|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515227|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515228|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515229|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515468|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515964|NCT00765570|P1|Participant Flow|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
515230|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515231|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515232|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515233|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515234|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515235|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515236|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515237|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515238|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515239|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515240|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515469|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515777|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515241|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515242|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515243|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515244|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515245|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515246|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515247|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515248|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515249|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515250|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515251|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515470|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515778|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515252|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515253|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515254|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515255|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515256|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515257|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515258|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515259|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515260|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515261|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515262|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515471|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515965|NCT00765570|O2|Outcome|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
515263|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515264|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515265|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515266|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515267|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515268|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515269|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515270|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515271|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515272|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515273|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515472|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515779|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515274|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515275|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515276|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515277|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515278|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515279|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515280|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515281|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515282|NCT00772005|E4|Reported Event|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515283|NCT00772005|E3|Reported Event|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515284|NCT00772005|E2|Reported Event|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515473|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515828|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515285|NCT00772005|E1|Reported Event|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
515286|NCT00772031|B3|Baseline|Total|Total of all reporting groups
515287|NCT00772031|B2|Baseline|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
515288|NCT00772031|B1|Baseline|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
515289|NCT00772031|P2|Participant Flow|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
515290|NCT00772031|P1|Participant Flow|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
515291|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
515292|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
515293|NCT00772031|O4|Outcome|Topiramate Plus Placebo, Prior, Stable Topiramate|Participants with prior stable topiramate use received a placebo and topiramate.
515294|NCT00772031|O3|Outcome|Topiramate Plus Propranolol, Prior, Stable Topiramate|Participants with prior stable topiramate use received propranolol and topiramate.
515295|NCT00772031|O2|Outcome|Topiramate Plus Placebo, no Prior, Stable Topiramate|Participants without prior stable topiramate use received a placebo and topiramate.
515296|NCT00772031|O1|Outcome|Topiramate Plus Propranolol, no Prior, Stable Topiramate|Participants without prior stable topiramate use received propranolol and topiramate.
515297|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
515298|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
515299|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
515300|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
515301|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
515302|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
515303|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
515304|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
515305|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
515306|NCT00772031|O1|Outcome|Topiramate Plus Proporanolol|Participants will receive propranolol and topiramate.
515307|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
515308|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
515309|NCT00772031|E2|Reported Event|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
515310|NCT00772031|E1|Reported Event|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
515311|NCT00772070|B3|Baseline|Total|Total of all reporting groups
515312|NCT00772070|B2|Baseline|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
515313|NCT00772070|B1|Baseline|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
515314|NCT00772070|P2|Participant Flow|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
515315|NCT00772070|P1|Participant Flow|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
515316|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
515317|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
515318|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
515319|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
515320|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
515321|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
515322|NCT00772070|E2|Reported Event|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
515323|NCT00772070|E1|Reported Event|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
515324|NCT00772109|B5|Baseline|Total|Total of all reporting groups
515325|NCT00772109|B4|Baseline|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
515326|NCT00772109|B3|Baseline|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
515327|NCT00772109|B2|Baseline|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
515328|NCT00772109|B1|Baseline|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
515329|NCT00772109|P4|Participant Flow|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
515330|NCT00772109|P3|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
515331|NCT00772109|P2|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
515332|NCT00772109|P1|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
516307|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
515474|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515475|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515476|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515477|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515478|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515479|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515480|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515481|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515482|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515483|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515484|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515485|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515486|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515487|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515488|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515489|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515490|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515491|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515517|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515492|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515493|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515494|NCT00764790|E3|Reported Event|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515495|NCT00764790|E2|Reported Event|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515496|NCT00764790|E1|Reported Event|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
515497|NCT00764868|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
515498|NCT00764868|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
515499|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
515500|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
515501|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
515502|NCT00764868|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
515503|NCT00764881|B3|Baseline|Total|Total of all reporting groups
515504|NCT00764881|B2|Baseline|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515505|NCT00764881|B1|Baseline|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515506|NCT00764881|P2|Participant Flow|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515507|NCT00764881|P1|Participant Flow|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515508|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515509|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515510|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515511|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515512|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515513|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515514|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515515|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515516|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515957|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515519|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515520|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515521|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515522|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515523|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515524|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515525|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515526|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515527|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515528|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515529|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515530|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515531|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515532|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515533|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515534|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515535|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515536|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515537|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515538|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515539|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515540|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515541|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515542|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515543|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515544|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515545|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
516308|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515546|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515547|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515548|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515549|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515550|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515551|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515552|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515553|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515554|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515555|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515556|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515557|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515558|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515559|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515560|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515561|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515562|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515563|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515564|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515565|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515566|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515567|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515568|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515569|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515570|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515571|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515572|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515573|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
516309|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
515574|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515575|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515576|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515577|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515578|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515579|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515580|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515581|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515582|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515583|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515584|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515585|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515586|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515587|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515588|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515589|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515590|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515591|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515592|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515593|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515594|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515595|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515596|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515597|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515598|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515599|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515600|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515601|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
516310|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515602|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515603|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515604|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515605|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515606|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515607|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515608|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515609|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515610|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515611|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515612|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515613|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515614|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515615|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515616|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515617|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515618|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515619|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515620|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515621|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515622|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515623|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515624|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515625|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515626|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515627|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515628|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515629|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
516311|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
515630|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515631|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515632|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515633|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515634|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515635|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515636|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515637|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515638|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515639|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515640|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515641|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515642|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515643|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515644|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515645|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515646|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515647|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515648|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515649|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515650|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515651|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515652|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515653|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515654|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515655|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515656|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515657|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
516312|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515658|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515659|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515660|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515661|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515662|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515663|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515664|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515665|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515666|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515667|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515668|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515669|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515670|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515671|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515672|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515673|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515674|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515675|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515676|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515677|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515678|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515679|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515680|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515681|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515682|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515683|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515684|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515685|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
516313|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
515686|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515687|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515688|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515689|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515690|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515691|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515692|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515693|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515694|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515695|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515696|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515697|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515698|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515699|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515700|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515701|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515702|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515703|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515704|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515705|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515706|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515707|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515708|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515709|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515710|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515711|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515712|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515713|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
516314|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515714|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515715|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515716|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515717|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515718|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515719|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515720|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515721|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515722|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515723|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515724|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515725|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515726|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
515727|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
515728|NCT00764881|E2|Reported Event|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles
515729|NCT00764881|E1|Reported Event|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles
515730|NCT00764946|B4|Baseline|Total|Total of all reporting groups
515731|NCT00764946|B3|Baseline|Participants Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515732|NCT00764946|B2|Baseline|Participants Intolerant to Current Therapy|Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515733|NCT00764946|B1|Baseline|Participants Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515734|NCT00764946|P3|Participant Flow|Participants Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515735|NCT00764946|P2|Participant Flow|Participants Intolerant to Current Therapy|Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515736|NCT00764946|P1|Participant Flow|Participants Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg twice daily (b.i.d.) plus other antiretroviral agents at the discretion of the investigator.
515737|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515738|NCT00764946|O2|Outcome|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515739|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515740|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515741|NCT00764946|O2|Outcome|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515780|NCT00765063|E1|Reported Event|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515742|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515743|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515744|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515745|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515746|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515747|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515748|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515749|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515750|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515751|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515752|NCT00764946|O3|Outcome|Treatment Naive|
515753|NCT00764946|O2|Outcome|Treatment-Experienced - Treatment Intolerant|
515754|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|
515755|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515756|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515757|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515758|NCT00764946|E3|Reported Event|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515759|NCT00764946|E2|Reported Event|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515760|NCT00764946|E1|Reported Event|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
515761|NCT00765037|B1|Baseline|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
515762|NCT00765037|P1|Participant Flow|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
515763|NCT00765037|O1|Outcome|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
515764|NCT00765037|E1|Reported Event|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
515765|NCT00765063|B1|Baseline|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515766|NCT00765063|P1|Participant Flow|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515767|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515768|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515769|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515770|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515771|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515772|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
515783|NCT00765076|B2|Baseline|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515784|NCT00765076|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515785|NCT00765076|P3|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515786|NCT00765076|P2|Participant Flow|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515787|NCT00765076|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515788|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515789|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515790|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515791|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515792|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515793|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515794|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515795|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515796|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515797|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515798|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515799|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515800|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515801|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515802|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515803|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515804|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515805|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515806|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515807|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515808|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515809|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515810|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515811|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515812|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515813|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515814|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515815|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515816|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515817|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515818|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515819|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515820|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515821|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515822|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515823|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515824|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515825|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515826|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515827|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515829|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515830|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515831|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515832|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515833|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515834|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515835|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515836|NCT00765076|E3|Reported Event|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
515837|NCT00765076|E2|Reported Event|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
515838|NCT00765076|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
515839|NCT00765102|B1|Baseline|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
515840|NCT00765102|P1|Participant Flow|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
515841|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
515842|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
515843|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
515844|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
515845|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
515846|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
515847|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
515848|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
515849|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
515850|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
515851|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
515852|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
515853|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
515854|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
515855|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
515856|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
515857|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
515958|NCT00765388|E2|Reported Event|SenSura Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
516315|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
515858|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
516329|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
515859|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
515860|NCT00765102|E1|Reported Event|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
515861|NCT00765128|B3|Baseline|Total|Total of all reporting groups
515862|NCT00765128|B2|Baseline|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515863|NCT00765128|B1|Baseline|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515864|NCT00765128|P2|Participant Flow|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515865|NCT00765128|P1|Participant Flow|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515866|NCT00765128|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515867|NCT00765128|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515868|NCT00765128|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515869|NCT00765128|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515870|NCT00765128|E2|Reported Event|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515871|NCT00765128|E1|Reported Event|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515872|NCT00765193|B1|Baseline|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
515873|NCT00765193|P1|Participant Flow|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
515874|NCT00765193|O2|Outcome|Full Body Examination|
515875|NCT00765193|O1|Outcome|Problem Area Examination|
515876|NCT00765193|E1|Reported Event|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
515877|NCT00765206|B1|Baseline|Entire Study Population|
515878|NCT00765206|P4|Participant Flow|Prilosec First, Then Zegerid (7-Day Dosing)|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
515879|NCT00765206|P3|Participant Flow|Zegerid First, Then Prilosec ( 7-Day Dosing)|Participants received Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
515880|NCT00765206|P2|Participant Flow|Prilosec First, Then Zegerid (1-Day Dosing)|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
515881|NCT00765206|P1|Participant Flow|Zegerid First, Then Prilosec (1- Day Dosing)|Participants received Zegerid Over-the-counter (OTC) Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
515882|NCT00765206|O2|Outcome|Prilosec|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
515883|NCT00765206|O1|Outcome|Zegerid|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
515884|NCT00765206|E2|Reported Event|Prilosec|Subjects who received a single dose of Prilosec per day for either 1 or 7 days.
515885|NCT00765206|E1|Reported Event|Zegerid|Subjects who received a single dose of Zegerid per day for either 1 or 7 days.
515886|NCT00765232|B3|Baseline|Total|Total of all reporting groups
515887|NCT00765232|B2|Baseline|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515888|NCT00765232|B1|Baseline|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515889|NCT00765232|P2|Participant Flow|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515890|NCT00765232|P1|Participant Flow|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515891|NCT00765232|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515892|NCT00765232|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515893|NCT00765232|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515894|NCT00765232|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515895|NCT00765232|E2|Reported Event|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515896|NCT00765232|E1|Reported Event|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
515897|NCT00765245|B3|Baseline|Total|Total of all reporting groups
515966|NCT00765570|O1|Outcome|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
515967|NCT00765570|O2|Outcome|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
516330|NCT00766467|E2|Reported Event|Placebo|Placebo: Taken orally once a day in the morning.
515898|NCT00765245|B2|Baseline|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles
Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
515899|NCT00765245|B1|Baseline|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
515900|NCT00765245|P2|Participant Flow|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles
Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
515901|NCT00765245|P1|Participant Flow|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
515902|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles
Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
515903|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
515904|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles
Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
515905|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
515906|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles
Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
515907|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
515908|NCT00765245|E2|Reported Event|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles
Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
515909|NCT00765245|E1|Reported Event|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
515910|NCT00765336|B3|Baseline|Total|Total of all reporting groups
515911|NCT00765336|B2|Baseline|Placebo|daily dose of Placebo
515912|NCT00765336|B1|Baseline|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
515913|NCT00765336|P2|Participant Flow|Placebo|daily dose of Placebo
515914|NCT00765336|P1|Participant Flow|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
515915|NCT00765336|O2|Outcome|Placebo|daily dose of Placebo
515916|NCT00765336|O1|Outcome|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
515917|NCT00765336|E2|Reported Event|Placebo|daily dose of Placebo
515918|NCT00765336|E1|Reported Event|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
515919|NCT00765362|B1|Baseline|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
515920|NCT00765362|P1|Participant Flow|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
515959|NCT00765388|E1|Reported Event|Hollister Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515960|NCT00765570|B3|Baseline|Total|Total of all reporting groups
515961|NCT00765570|B2|Baseline|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
516316|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
515921|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
515922|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
515923|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
515924|NCT00765362|E1|Reported Event|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
515925|NCT00765375|B1|Baseline|Active on One Side and Placebo on the Other Side of Face|Botulinum Neurotoxin Type A (Botox) on one side of face, and bacteriostatic saline solution on the other side of face.
515926|NCT00765375|P1|Participant Flow|Active on One Side, Placebo on the Other Side of Face|Botulinum Neurotoxin Type A (Botox) treatment on one side of the face and bacteriostatic saline solution (Placebo) on the other side of the face.
515927|NCT00765375|O2|Outcome|2- Placebo|Saline Solution
515928|NCT00765375|O1|Outcome|1- Active|Botulinum Neurotoxin Type A (Botox)
515929|NCT00765375|E2|Reported Event|2- Placebo|Saline Solution
515930|NCT00765375|E1|Reported Event|1- Active|Botulinum Neurotoxin Type A (Botox)
515931|NCT00765388|B1|Baseline|Entire Study Population|Includes groups randomized to receive SenSura Uro first and Hollister Uro first
515932|NCT00765388|P2|Participant Flow|SenSura Uro First, Then Hollister Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515933|NCT00765388|P1|Participant Flow|Hollister Uro First, Then SenSura Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515934|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515935|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515936|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515937|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515938|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515939|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515940|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515941|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515942|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515943|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515944|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515945|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515946|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515947|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515948|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515949|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515950|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515951|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515952|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515953|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515954|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515955|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
515956|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
516317|NCT00766415|E2|Reported Event|Placebo|Placebo, twice daily
515968|NCT00765570|O1|Outcome|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
515969|NCT00765570|E2|Reported Event|Treatment Group-2|Treatment Group 2-15 treatments with standard radiation
515970|NCT00765570|E1|Reported Event|Treatment Group 1|Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation
515971|NCT00765648|B3|Baseline|Total|Total of all reporting groups
515972|NCT00765648|B2|Baseline|Bolus Labetalol Began at 20 mg Over 2 Minutes|Labetalol
515973|NCT00765648|B1|Baseline|Nicardipine Dosing Was 5 mg/Hour|nicardipine intravenous
515974|NCT00765648|P2|Participant Flow|Bolus Labetalol Began at 20 mg Over 2 Minutes|Labetalol
515975|NCT00765648|P1|Participant Flow|Nicardipine Dosing Was 5 mg/Hour|nicardipine intravenous
515976|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
515977|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
515978|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
515979|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
515980|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
515981|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
515982|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
515983|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
515984|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
515985|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
515986|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
515987|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
515988|NCT00765648|E2|Reported Event|Labetalol|Bolus Labetalol began at 20 mg over 2 minutes
515989|NCT00765648|E1|Reported Event|Nicardipine|Nicardipine dosing was 5 mg/hour
515990|NCT00765661|B3|Baseline|Total|Total of all reporting groups
515991|NCT00765661|B2|Baseline|Group B|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf®: Prograf® capsules, twice daily, orally"
515992|NCT00765661|B1|Baseline|Gorup A|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
tacrolimus (Tacro™): LCP - Tacro™ tablets, orally"
515993|NCT00765661|P2|Participant Flow|Group B|Randomized, parallel-group, open-label, multi-center study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of Prograf capsules in the first 2 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive Prograf capsules in 2 equally divided doses, starting at 0.1 mg/kg every 12 hours (0.2 mg/kg total daily dose) as recommended in the U.S. Prescribing Information
515994|NCT00765661|P1|Participant Flow|Group A|Randomized, parallel group, open-label, multi-center study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of LCP-Tacro tablets in the first 2 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive LCP-Tacro tablets orally once daily (QD) in the morning, with an interval of 24 +/-1 hours between doses, starting at 0.14 mg/kg (the starting daily dose for African-American patients was 0.17 mg/kg)
515995|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
515996|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
515997|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
515998|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
515999|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
516000|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
516001|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
516002|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
516003|NCT00765661|E2|Reported Event|Group B|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf®: Prograf® capsules, twice daily"
516318|NCT00766415|E1|Reported Event|AZD1981|AZD1981 1000 mg, twice daily
516004|NCT00765661|E1|Reported Event|Group A|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
tacrolimus (Tacro™): LCP - Tacro™ tablets"
516005|NCT00765674|B5|Baseline|Total|Total of all reporting groups
516006|NCT00765674|B4|Baseline|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516007|NCT00765674|B3|Baseline|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516008|NCT00765674|B2|Baseline|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516009|NCT00765674|B1|Baseline|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516010|NCT00765674|P4|Participant Flow|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516011|NCT00765674|P3|Participant Flow|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516012|NCT00765674|P2|Participant Flow|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516013|NCT00765674|P1|Participant Flow|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516014|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516015|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516016|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516054|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516055|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516056|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516017|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516018|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516019|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516020|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516021|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516022|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516023|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516024|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516025|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516026|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516027|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516028|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516129|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
516319|NCT00766467|B3|Baseline|Total|Total of all reporting groups
516029|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516030|NCT00765674|E4|Reported Event|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516031|NCT00765674|E3|Reported Event|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
516032|NCT00765674|E2|Reported Event|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516033|NCT00765674|E1|Reported Event|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
516034|NCT00765726|B1|Baseline|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
516035|NCT00765726|P1|Participant Flow|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
516036|NCT00765726|O1|Outcome|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
516037|NCT00765726|E1|Reported Event|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
516038|NCT00765765|B1|Baseline|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.
hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
516039|NCT00765765|P1|Participant Flow|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.
hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
516040|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.
hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
516041|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.
hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
516042|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.
hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
516043|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.
hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
516044|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.
hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
516045|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.
hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
516046|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.
hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
516047|NCT00765765|E1|Reported Event|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.
hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
516048|NCT00765817|B3|Baseline|Total|Total of all reporting groups
516049|NCT00765817|B2|Baseline|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516050|NCT00765817|B1|Baseline|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516051|NCT00765817|P2|Participant Flow|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516052|NCT00765817|P1|Participant Flow|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516053|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516057|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516058|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516059|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516060|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516061|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516062|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516063|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516064|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516065|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516066|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516067|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516068|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516069|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516070|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516071|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516072|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516073|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516074|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516075|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516076|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516077|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516078|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516079|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516080|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516081|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516082|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516083|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516084|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516085|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516086|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516087|NCT00765817|E2|Reported Event|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
516088|NCT00765817|E1|Reported Event|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
516089|NCT00765843|B4|Baseline|Total|Total of all reporting groups
516323|NCT00766467|P1|Participant Flow|Armodafinil|Armodafinil: 150mg taken orally once a day in the morning.
516090|NCT00765843|B3|Baseline|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516091|NCT00765843|B2|Baseline|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516092|NCT00765843|B1|Baseline|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516093|NCT00765843|P3|Participant Flow|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516094|NCT00765843|P2|Participant Flow|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516095|NCT00765843|P1|Participant Flow|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516096|NCT00765843|O3|Outcome|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516097|NCT00765843|O2|Outcome|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516098|NCT00765843|O1|Outcome|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516099|NCT00765843|E3|Reported Event|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516100|NCT00765843|E2|Reported Event|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516101|NCT00765843|E1|Reported Event|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
516102|NCT00765882|B4|Baseline|Total|Total of all reporting groups
516103|NCT00765882|B3|Baseline|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
516104|NCT00765882|B2|Baseline|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
516105|NCT00765882|B1|Baseline|Placebo|Dose matched placebo, oral administration, once per day.
516106|NCT00765882|P3|Participant Flow|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
516107|NCT00765882|P2|Participant Flow|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
516108|NCT00765882|P1|Participant Flow|Placebo|Dose matched placebo, oral administration, once per day.
516109|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
516110|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
516111|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
516112|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
516113|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
516114|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
516115|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
516116|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
516117|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
516118|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
516119|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
516120|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
516121|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
516122|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
516123|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
516124|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
516125|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
516126|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
516127|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
516128|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
516137|NCT00765895|B2|Baseline|Placebo|"No treatment
Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
516138|NCT00765895|B1|Baseline|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
516139|NCT00765895|P2|Participant Flow|Placebo|"No treatment
Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
516140|NCT00765895|P1|Participant Flow|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
516141|NCT00765895|O2|Outcome|Placebo|"No treatment
Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
516142|NCT00765895|O1|Outcome|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
516143|NCT00765895|E2|Reported Event|Placebo|"No treatment
Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
516144|NCT00765895|E1|Reported Event|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
516145|NCT00765947|B1|Baseline|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
516146|NCT00765947|P1|Participant Flow|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
516147|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
516148|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
516149|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
516150|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
516151|NCT00765947|E3|Reported Event|Aliskiren + HCTZ + Amlodipine|Aliskiren + HCTZ + Amlodipine treatment step
516152|NCT00765947|E2|Reported Event|Aliskiren + HCTZ|Aliskiren and HCTZ treatment step
516153|NCT00765947|E1|Reported Event|Aliskiren|Aliskiren treatment step
516154|NCT00766051|B3|Baseline|Total|Total of all reporting groups
516155|NCT00766051|B2|Baseline|Intervention Group|This is the only Matched Historical Comparison group infants that the analysis refer to. The intervention group consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia.
516156|NCT00766051|B1|Baseline|Matched Historical Comparison Group|This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee (1978) and consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia.
516157|NCT00766051|P2|Participant Flow|Matched Historical Comparison Group|Matched Historical Controls drawn from a three year period.
516158|NCT00766051|P1|Participant Flow|Intervention Group|This is the only intervention group that the analysis apply to.
516159|NCT00766051|O2|Outcome|Intervention Group Post Test|This is the only intervention group that the analysis apply to.
516160|NCT00766051|O1|Outcome|Intervention Group Pre-test|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
516161|NCT00766051|O2|Outcome|Intervention Group Post Test|This is the only intervention group that the analysis apply to.
516320|NCT00766467|B2|Baseline|Placebo|Placebo: Taken orally once a day in the morning.
516162|NCT00766051|O1|Outcome|Intervention Group Pre-test|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
516163|NCT00766051|O1|Outcome|Intervention Group|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
516164|NCT00766051|O2|Outcome|Matched Historical Comparison Group|This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee, (1978).
516165|NCT00766051|O1|Outcome|Intervention Group|This is the only intervention group that the analysis apply to. The intervention and the matched historical comparison group consisted of preterm, near term and full term infants with feeding problems.
516166|NCT00766051|E1|Reported Event|Intervention Group|This is the only intervention group that the analysis apply to.
516167|NCT00766090|B3|Baseline|Total|Total of all reporting groups
516168|NCT00766090|B2|Baseline|FP 200 µg, FP 100 µg, and Placebo Via DISKUS|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516169|NCT00766090|B1|Baseline|FF 200 µg, FF 100 µg, and Placebo Via DPI|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516170|NCT00766090|P12|Participant Flow|Sequence 12: FP 200 µg, FP 100 µg, Placebo|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516171|NCT00766090|P11|Participant Flow|Sequence 11: FP 200 µg, Placebo, FP 100 µg|Participants received FP 200 µg inhalation powder OD in the evening, placebo BID, and FP 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516172|NCT00766090|P10|Participant Flow|Sequence 10: FP 100 µg, FP 200 µg, Placebo|Participants received FP 100 µg inhalation powder BID, FP 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516173|NCT00766090|P9|Participant Flow|Sequence 9: FP 100 µg, Placebo, FP 200 µg|Participants received FP 100 µg inhalation powder BID, placebo BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516174|NCT00766090|P8|Participant Flow|Sequence 8: Placebo, FP 100 µg, FP 200 µg|Participants received placebo BID, FP 100 µg inhalation powder BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516175|NCT00766090|P7|Participant Flow|Sequence 7: Placebo, FP 200 µg, FP 100 µg|Participants received placebo twice daily (BID), fluticasone propionate (FP) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FP 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516176|NCT00766090|P6|Participant Flow|Sequence 6: FF 200 µg, FF 100 µg, Placebo|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516177|NCT00766090|P5|Participant Flow|Sequence 5: FF 200 µg, Placebo, FF 100 µg|Participants received FF 200 µg inhalation powder OD in the evening, placebo BID, and FF 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516178|NCT00766090|P4|Participant Flow|Sequence 4: FF 100 µg, FF 200 µg, Placebo|Participants received FF 100 µg inhalation powder BID, FF 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516179|NCT00766090|P3|Participant Flow|Sequence 3: FF 100 µg, Placebo, FF 200 µg|Participants received FF 100 µg inhalation powder BID, placebo BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516180|NCT00766090|P2|Participant Flow|Sequence 2: Placebo, FF 100 µg, FF 200 µg|Participants received placebo BID, FF 100 µg inhalation powder BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516181|NCT00766090|P1|Participant Flow|Sequence 1: Placebo, FF 200 µg, FF 100 µg|Participants received placebo twice daily (BID), fluticasone furoate (FF) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FF 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516182|NCT00766090|O2|Outcome|FP 200 µg, FP 100 µg, and Placebo Via DISKUS|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516183|NCT00766090|O1|Outcome|FF 200 µg, FF 100 µg, and Placebo Via DPI|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516184|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516185|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516186|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516187|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516188|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516189|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516190|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516191|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516192|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516193|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516194|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516195|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516196|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516197|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516321|NCT00766467|B1|Baseline|Armodafinil|Armodafinil: Taken orally once a day in the morning.
516322|NCT00766467|P2|Participant Flow|Placebo|Placebo: Taken orally once a day in the morning
516198|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516199|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516200|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516201|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516202|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516203|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516204|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516205|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516206|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516207|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516208|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516209|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516210|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516211|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516212|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516213|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516214|NCT00766090|E5|Reported Event|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516215|NCT00766090|E4|Reported Event|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516216|NCT00766090|E3|Reported Event|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516217|NCT00766090|E2|Reported Event|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516506|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516218|NCT00766090|E1|Reported Event|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
516219|NCT00766363|B5|Baseline|Total|Total of all reporting groups
516220|NCT00766363|B4|Baseline|Placebo|1 capsule per day for 28 days.
516221|NCT00766363|B3|Baseline|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516222|NCT00766363|B2|Baseline|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
516223|NCT00766363|B1|Baseline|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516224|NCT00766363|P4|Participant Flow|Placebo|1 capsule per day for 28 days.
516225|NCT00766363|P3|Participant Flow|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516226|NCT00766363|P2|Participant Flow|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
516227|NCT00766363|P1|Participant Flow|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516228|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516229|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516230|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516231|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516232|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516233|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516234|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
516235|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516236|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
516237|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516238|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
516239|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516240|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
516241|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516242|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
516243|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516244|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
516245|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516246|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516247|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
516248|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516249|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516250|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
516251|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516252|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516253|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
516254|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516255|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
516256|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516257|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
516258|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516259|NCT00766363|E4|Reported Event|Placebo|1 capsule per day for 28 days.
516260|NCT00766363|E3|Reported Event|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
516261|NCT00766363|E2|Reported Event|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
516262|NCT00766363|E1|Reported Event|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
516263|NCT00766376|B1|Baseline|Erbium Laser|Each subject will undergo a minimum of 1 treatment with 5 scheduled follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
516264|NCT00766376|P1|Participant Flow|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
516265|NCT00766376|O1|Outcome|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
516266|NCT00766376|O1|Outcome|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
516267|NCT00766376|E1|Reported Event|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
516268|NCT00766415|B3|Baseline|Total|Total of all reporting groups
516269|NCT00766415|B2|Baseline|Placebo|Placebo, twice daily
516270|NCT00766415|B1|Baseline|AZD1981|AZD1981 1000 mg, twice daily
516271|NCT00766415|P2|Participant Flow|Placebo|Placebo, twice daily
516272|NCT00766415|P1|Participant Flow|AZD1981|AZD1981 1000 mg, twice daily
516273|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
516274|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
516275|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
516276|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
516277|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
516331|NCT00766467|E1|Reported Event|Armodafinil|Armodafinil: Taken orally once a day in the morning.
516332|NCT00766493|B1|Baseline|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
516333|NCT00766493|P1|Participant Flow|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
516334|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
516335|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
516336|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
516337|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
516338|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
516339|NCT00766493|E1|Reported Event|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
516340|NCT00766506|B3|Baseline|Total|Total of all reporting groups
516341|NCT00766506|B2|Baseline|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516342|NCT00766506|B1|Baseline|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516343|NCT00766506|P2|Participant Flow|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516344|NCT00766506|P1|Participant Flow|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516345|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516346|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516347|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516348|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516349|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516350|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516351|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516352|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516353|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516354|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516355|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516507|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516356|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516357|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516381|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic virus
516358|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516359|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516360|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516361|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516362|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516363|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516364|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516365|NCT00766506|E2|Reported Event|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
516366|NCT00766506|E1|Reported Event|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
516367|NCT00766532|B1|Baseline|Group 1|
516368|NCT00766532|P1|Participant Flow|Arm Title- Aromatase Inhibitor Therapy|calcium absorption was measured among subjects at baseline and after taking aromatase inhibitor therapy.
516369|NCT00766532|O1|Outcome|Aromatase Inhibitor Therapy|
516370|NCT00766532|E1|Reported Event|Group 1|
516371|NCT00766597|B1|Baseline|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus
Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
516372|NCT00766597|P1|Participant Flow|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus
Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
516373|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus
Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
516374|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus
Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
516375|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus
Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
516376|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus
Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
516377|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus
Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
516378|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus
Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
516508|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516379|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus
Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
516380|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus
Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
516382|NCT00766597|E1|Reported Event|Vicriviroc in Tablet Form (20/30mg) or Liquid Form (1mg/ml)|Drug: Vicriviroc Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen
516383|NCT00766636|B3|Baseline|Total|Total of all reporting groups
516384|NCT00766636|B2|Baseline|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
516385|NCT00766636|B1|Baseline|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.
Surgical removal of the pancreas and duodenum."
516386|NCT00766636|P2|Participant Flow|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
516387|NCT00766636|P1|Participant Flow|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.
Surgical removal of the pancreas and duodenum."
516388|NCT00766636|O2|Outcome|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
516389|NCT00766636|O1|Outcome|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.
Surgical removal of the pancreas and duodenum."
516390|NCT00766636|E2|Reported Event|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
516391|NCT00766636|E1|Reported Event|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.
Surgical removal of the pancreas and duodenum."
516392|NCT00766649|B1|Baseline|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516393|NCT00766649|P1|Participant Flow|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516394|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516395|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516396|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516397|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516398|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516399|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516400|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516401|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516402|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516403|NCT00766649|E1|Reported Event|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
516404|NCT00766675|B1|Baseline|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516509|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516510|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516405|NCT00766675|P1|Participant Flow|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516406|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516407|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516515|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516408|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516409|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516410|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516411|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516412|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516413|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516414|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516415|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516416|NCT00766675|E1|Reported Event|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
516417|NCT00766753|B3|Baseline|Total|Total of all reporting groups
516418|NCT00766753|B2|Baseline|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516419|NCT00766753|B1|Baseline|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516420|NCT00766753|P2|Participant Flow|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516421|NCT00766753|P1|Participant Flow|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516422|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516423|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516424|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516425|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516426|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516427|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516428|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516429|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
516516|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516517|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516518|NCT00772538|E2|Reported Event|Tio R5|Patients treated with tiotropium inhalation solution 5 Î¼g qd
516430|NCT00766753|E1|Reported Event|Alpha DC1 Vaccine + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine, up to 4 vaccines
516431|NCT00766831|B1|Baseline|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516432|NCT00766831|P1|Participant Flow|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516433|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516434|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516435|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516436|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516437|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516438|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516439|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516440|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516441|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516442|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516443|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516444|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516511|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516519|NCT00772538|E1|Reported Event|Placebo|Patients treated with matching placebo
516520|NCT00772577|B3|Baseline|Total|Total of all reporting groups
516521|NCT00772577|B2|Baseline|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
516522|NCT00772577|B1|Baseline|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
516445|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516446|NCT00766831|E1|Reported Event|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
516447|NCT00772538|B3|Baseline|Total|Total of all reporting groups
516448|NCT00772538|B2|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516449|NCT00772538|B1|Baseline|Placebo|Patients treated with matching placebo
516450|NCT00772538|P2|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516451|NCT00772538|P1|Participant Flow|Placebo|Patients treated with matching placebo
516452|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516453|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516454|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516455|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516456|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516457|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516458|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516459|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516460|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516461|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516462|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516463|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516464|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516465|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516466|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516467|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516468|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516469|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516470|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516471|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516472|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516473|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516474|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516475|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516476|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516477|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516478|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516479|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516480|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516481|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516482|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516483|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516484|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516485|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516486|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516487|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516488|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516489|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516490|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516491|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516492|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516493|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516494|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516495|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516496|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516497|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516498|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516499|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516500|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516501|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516502|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516503|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516504|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
516505|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
516523|NCT00772577|P2|Participant Flow|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
516524|NCT00772577|P1|Participant Flow|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
516525|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
516526|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
516527|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
516528|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
516529|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
516530|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
516531|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
516532|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
516533|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
516534|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
516535|NCT00772577|E2|Reported Event|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
516536|NCT00772577|E1|Reported Event|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
516537|NCT00772590|B5|Baseline|Total|Total of all reporting groups
516538|NCT00772590|B4|Baseline|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
516539|NCT00772590|B3|Baseline|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
516540|NCT00772590|B2|Baseline|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
516541|NCT00772590|B1|Baseline|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
516542|NCT00772590|P4|Participant Flow|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
516543|NCT00772590|P3|Participant Flow|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
516544|NCT00772590|P2|Participant Flow|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
516545|NCT00772590|P1|Participant Flow|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
516546|NCT00772590|O4|Outcome|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
516547|NCT00772590|O3|Outcome|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
516548|NCT00772590|O2|Outcome|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
516549|NCT00772590|O1|Outcome|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
516550|NCT00772590|E4|Reported Event|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
516551|NCT00772590|E3|Reported Event|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
516552|NCT00772590|E2|Reported Event|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
516553|NCT00772590|E1|Reported Event|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
516554|NCT00772603|B4|Baseline|Total|Total of all reporting groups
516555|NCT00772603|B3|Baseline|Placebo|Placebo given once daily.
516556|NCT00772603|B2|Baseline|1200mg/Day SPN-804|1200mg SPN-804O given once daily
516557|NCT00772603|B1|Baseline|2400mg/Day SPN-804|2400mg SPN-804O once daily
516558|NCT00772603|P3|Participant Flow|Placebo|Placebo once daily
516559|NCT00772603|P2|Participant Flow|1200mg/Day SPN-804|1200mg SPN-804O once daily
516560|NCT00772603|P1|Participant Flow|2400mg/Day SPN-804|2400mg of SPN-804O once daily
516561|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
516562|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
516563|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
516564|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
516565|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
516566|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
516567|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
516568|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
516569|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
516570|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
516571|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
516572|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
516573|NCT00772603|O3|Outcome|Placebo|Placebo once daily.
516574|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804 once daily
516575|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804 once daily
516576|NCT00772603|E3|Reported Event|Placebo|placebo QD, given as four placebo tablets
516577|NCT00772603|E2|Reported Event|1200mg/Day SPN-804|1200mg total daily dose of SPN-804O QD, given as two 600mg tablets and two identical placebo tablets.
516578|NCT00772603|E1|Reported Event|2400mg/Day SPN-804|2400mg total daily dose of SPN-804O once a day (QD), given as four 600mg tablets
516579|NCT00772629|B3|Baseline|Total|Total of all reporting groups
516580|NCT00772629|B2|Baseline|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
516581|NCT00772629|B1|Baseline|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
516582|NCT00772629|P2|Participant Flow|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
516583|NCT00772629|P1|Participant Flow|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
516584|NCT00772629|O2|Outcome|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
516585|NCT00772629|O1|Outcome|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
516586|NCT00772629|E2|Reported Event|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
516587|NCT00772629|E1|Reported Event|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
516588|NCT00772668|B1|Baseline|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles
Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles
Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
516589|NCT00772668|P1|Participant Flow|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles
Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles
Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
516590|NCT00772668|O1|Outcome|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles
Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles
Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
516591|NCT00772668|E1|Reported Event|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles
Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles
Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
516592|NCT00772707|B1|Baseline|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
516593|NCT00772707|P1|Participant Flow|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
516594|NCT00772707|O1|Outcome|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
516595|NCT00772707|O1|Outcome|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
516596|NCT00772707|E1|Reported Event|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
516597|NCT00772772|B1|Baseline|Vitamin D3|
516598|NCT00772772|P1|Participant Flow|Vitamin D3|Vitamin D3 30,000 units PO weekly for 8 weeks
516599|NCT00772772|O1|Outcome|CKD Patients|
516600|NCT00772772|O1|Outcome|Patients With Chronic Kidney Disease (CKD)|CKD patients who were Vitamin D deficient and received Vitamin D3 repletion
516601|NCT00772772|E1|Reported Event|Vitamin D3|
516602|NCT00772941|B1|Baseline|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
516603|NCT00772941|P1|Participant Flow|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
516604|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
516605|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
516606|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
516607|NCT00772941|O2|Outcome|Varenicline - Without Antipsychotics as a Concomitant Drug|Varenicline without Antipsychotics as a Concomitant Drug
516608|NCT00772941|O1|Outcome|Varenicline - With Antipsychotics as a Concomitant Drug|Varenicline with Antipsychotics as a Concomitant Drug
516609|NCT00772941|O2|Outcome|Administration Not Prolonged After 12 Weeks|Participants without prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
516610|NCT00772941|O1|Outcome|Administration Prolonged After 12 Weeks|Participants with prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
516611|NCT00772941|O3|Outcome|>=41 Cigarettes Per Day|Participants with >=41 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
516612|NCT00772941|O2|Outcome|>=21 and <=40 Cigarettes Per Day|Participants with >=21 and <=40 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
516613|NCT00772941|O1|Outcome|<=20 Cigarettes Per Day|Participants with <=20 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
516614|NCT00772941|O6|Outcome|>= 80 kg at Baseline|Participants whose weights at baseline were more than or equal to 80 kg.
516615|NCT00772941|O5|Outcome|>=70 kg and <80 kg at Baseline|Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.
516616|NCT00772941|O4|Outcome|>=60 kg and <70 kg at Baseline|Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.
516617|NCT00772941|O3|Outcome|>=50 kg and <60 kg at Baseline|Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.
516618|NCT00772941|O2|Outcome|>=40 kg and <50 kg at Baseline|Participants whose weights at baseline were more than or equal to 40 kg and less than 50 kg.
516619|NCT00772941|O1|Outcome|<40 kg at Baseline|Participants whose weights at baseline were less than 40 kg.
516620|NCT00772941|O2|Outcome|Varenicline - Without Concomitant Therapies|Participants receiving no concomitant therapies while taking Varenicline according to Japanese Package Insert.
516693|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
516621|NCT00772941|O1|Outcome|Varenicline - With Concomitant Therapies|Participants receiving concomitant therapies while taking Varenicline according to Japanese Package Insert.
516622|NCT00772941|O2|Outcome|Varenicline - Without Concomitant Drugs|Participants taking no concomitant drugs while taking Varenicline according to Japanese Package Insert.
516623|NCT00772941|O1|Outcome|Varenicline - With Concomitant Drugs|Participants taking concomitant drugs while taking Varenicline according to Japanese Package Insert.
516624|NCT00772941|O2|Outcome|Varenicline - Without Chronic Obstructive Pulmonary Disease|Participants without chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
516625|NCT00772941|O1|Outcome|Varenicline - With Chronic Obstructive Pulmonary Disease|Participants with chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
516626|NCT00772941|O2|Outcome|>=65 Years|Participants with >=65 years taking Varenicline according to Japanese Package Insert.
516627|NCT00772941|O1|Outcome|<65 Years|Participants with <65 years taking Varenicline according to Japanese Package Insert.
516628|NCT00772941|O2|Outcome|Female|Female participants taking Varenicline according to Japanese Package Insert.
516629|NCT00772941|O1|Outcome|Male|Male participants taking Varenicline according to Japanese Package Insert.
516630|NCT00772941|E1|Reported Event|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
516631|NCT00772954|B4|Baseline|Total|Total of all reporting groups
516632|NCT00772954|B3|Baseline|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
516633|NCT00772954|B2|Baseline|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
516634|NCT00772954|B1|Baseline|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
516635|NCT00772954|P3|Participant Flow|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
516636|NCT00772954|P2|Participant Flow|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
516637|NCT00772954|P1|Participant Flow|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
516638|NCT00772954|O3|Outcome|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
516639|NCT00772954|O2|Outcome|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
516640|NCT00772954|O1|Outcome|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
516641|NCT00772954|E3|Reported Event|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
516642|NCT00772954|E2|Reported Event|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
516643|NCT00772954|E1|Reported Event|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
516644|NCT00772967|B1|Baseline|All Participants|All randomized participants
516645|NCT00772967|P6|Participant Flow|Ultracet, Naproxen, Placebo|Ultracet in Treatment Period 1, Naproxen in Treatment Period 2, Placebo in Treatment Period 3.
516646|NCT00772967|P5|Participant Flow|Naproxen, Placebo, Ultracet|Naproxen in Treatment Period 1, Placebo in Treatment Period 2, Ultracet inTreatment Period 3.
516647|NCT00772967|P4|Participant Flow|Placebo, Ultracet, Naproxen|Placebo in Treatment Period 1, Ultracet in Treatment Period 2, Naproxen in Treatment Period 3.
516648|NCT00772967|P3|Participant Flow|Ultracet, Placebo, Naproxen|Ultracet in Treatment Period 1, Placebo in Treatment Period 2, Naproxen in Treatment Period 3.
516649|NCT00772967|P2|Participant Flow|Naproxen, Ultracet, Placebo|Naproxen in Treatment Period 1, Ultracet in Treatment Period 2, Placebo in Treatment Period 3.
516650|NCT00772967|P1|Participant Flow|Placebo, Naproxen, Ultracet|Placebo in Treatment Period 1, Naproxen in Treatment Period 2, Ultracet in Treatment Period 3.
516651|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
516652|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
516653|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
516654|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
516655|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
516656|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
516657|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
516658|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
516659|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
516660|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
516661|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
516662|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
516663|NCT00772967|E3|Reported Event|Ultracet|Participants treated with at least one dose of Ultracet. Two participants were not treated due to discontinuation.
516664|NCT00772967|E2|Reported Event|Naproxen|Participants treated with at least one dose of Naproxen
516665|NCT00772967|E1|Reported Event|Placebo|Participants treated with at least one dose of Placebo
516666|NCT00773097|B1|Baseline|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
516694|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
516695|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
516667|NCT00773097|P1|Participant Flow|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
516668|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
516669|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
516670|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
516671|NCT00773097|E1|Reported Event|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
516672|NCT00773136|B1|Baseline|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
516673|NCT00773136|P1|Participant Flow|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
516674|NCT00773136|O2|Outcome|Control Group|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
516675|NCT00773136|O1|Outcome|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
516676|NCT00773136|E1|Reported Event|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
516677|NCT00773253|B3|Baseline|Total|Total of all reporting groups
516678|NCT00773253|B2|Baseline|Multi-channel EMG-guided Botox Injection Then Single Channel|Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design.
516679|NCT00773253|B1|Baseline|Standard EMG Guided Injections Then Multi-channel|All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.
516680|NCT00773253|P2|Participant Flow|Multi-channel EMG-guided Botox Injection Then Standard EMG Inj|Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel (standard) EMG-guided Botox, depending on which group they are assigned in the cross-over design.
516681|NCT00773253|P1|Participant Flow|Standard EMG Guided Injections Then Multi-channel Injections|All patients will undergo injection using conventional single channel (standard)EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.
516682|NCT00773253|O2|Outcome|Multi-channel EMG-guided Botox Injection|Patients will receive multi-channel EMG-guided Botox injection.
516683|NCT00773253|O1|Outcome|Standard EMG Guided Injections|All patients underwent single channel (standard)EMG-guided technique.
516684|NCT00773253|E2|Reported Event|Multi-channel EMG-guided Botox Injection|Patients will receive multi-channel EMG-guided Botox injection.
516685|NCT00773253|E1|Reported Event|Standard EMG Guided Injections|All patients underwent single channel (standard)EMG-guided technique.
516686|NCT00773279|B1|Baseline|Entire Trial Population|Participants who in random order received usual insulin treatment with pre-filled pen device PDS290 for 12 weeks followed by switch to pre-filled pen device FlexPen® for 12 weeks or vice versa. The frequency of basal and bolus injections were kept the same throughout the trial. Both prefilled pens were self-administered subcutaneously by the participants.
516687|NCT00773279|P2|Participant Flow|FlexPen® -> PDS290|
516688|NCT00773279|P1|Participant Flow|PDS290 -> FlexPen®|
516689|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
516690|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
516691|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
516692|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
516696|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
516697|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
516698|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
516699|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
516700|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
516701|NCT00773279|O1|Outcome|Entire Trial Population|Participants who in random order received usual insulin treatment with pre-filled pen device PDS290 for 12 weeks followed by switch to pre-filled pen device FlexPen® for 12 weeks or vice versa. The frequency of basal and bolus injections were kept the same throughout the trial. Both prefilled pens were self-administered subcutaneously by the participants.
516702|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
516703|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
516704|NCT00773279|E2|Reported Event|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
516705|NCT00773279|E1|Reported Event|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
516706|NCT00773370|B3|Baseline|Total|Total of all reporting groups
516707|NCT00773370|B2|Baseline|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
516708|NCT00773370|B1|Baseline|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
516709|NCT00773370|P2|Participant Flow|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
516710|NCT00773370|P1|Participant Flow|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
516711|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
516712|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
516713|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
516714|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
516715|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
523181|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
516716|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
516717|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
516718|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
516719|NCT00773370|E2|Reported Event|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.
Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
516720|NCT00773370|E1|Reported Event|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.
APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
516721|NCT00773383|B1|Baseline|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516722|NCT00773383|P1|Participant Flow|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516723|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516724|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516725|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516726|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516727|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516728|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516729|NCT00773383|O4|Outcome|R1507_Baseline Missing|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) Includes all participants with missing fasting glucose at baseline
516730|NCT00773383|O3|Outcome|R1507_Baseline Diabetes Mellitus|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline ≥ 126 mg/dL"
516731|NCT00773383|O2|Outcome|R1507_Baseline Impaired Fasting Glucose|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline ≥ 110 to < 126 mg/dL"
516732|NCT00773383|O1|Outcome|R1507_Baseline Glucose Normal|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline < 110 mg/dL."
516733|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516734|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516735|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516736|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516737|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516738|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516739|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516740|NCT00773383|E1|Reported Event|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
516741|NCT00773461|B3|Baseline|Total|Total of all reporting groups
523182|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
516742|NCT00773461|B2|Baseline|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516743|NCT00773461|B1|Baseline|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516744|NCT00773461|P2|Participant Flow|Tocilizumab + DMARDs|Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
516745|NCT00773461|P1|Participant Flow|Placebo + DMARDs|Participants received placebo intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
516746|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516747|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516748|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516749|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516750|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516751|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516752|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516753|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516754|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516755|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516756|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516757|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516758|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516759|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516760|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516761|NCT00773461|O1|Outcome|Placebo+DMARD|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516762|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516763|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516764|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516765|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516766|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516767|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516768|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516769|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516770|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516771|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516772|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516773|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516774|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516775|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516776|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516777|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516778|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516779|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516780|NCT00773461|E2|Reported Event|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
516781|NCT00773461|E1|Reported Event|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
517721|NCT00774748|O1|Outcome|All Participants|All participants on both dosing schedules, once and twice daily.
516782|NCT00773474|B1|Baseline|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
517415|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
516783|NCT00773474|P1|Participant Flow|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
516784|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
516785|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
516786|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
516787|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
516788|NCT00773474|E1|Reported Event|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
516789|NCT00773734|B5|Baseline|Total|Total of all reporting groups
516790|NCT00773734|B4|Baseline|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516791|NCT00773734|B3|Baseline|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516792|NCT00773734|B2|Baseline|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
516793|NCT00773734|B1|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).
516794|NCT00773734|P6|Participant Flow|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516795|NCT00773734|P5|Participant Flow|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516796|NCT00773734|P4|Participant Flow|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516797|NCT00773734|P3|Participant Flow|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516798|NCT00773734|P2|Participant Flow|Apremilast 10mg BID|Participants were initially randomized to apremilast (APR) 10 mg by mouth (PO) BID during the Placebo-controlled Phase (Weeks 0-16).
516799|NCT00773734|P1|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
516800|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516944|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517376|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
517722|NCT00774748|O1|Outcome|All Participants|All participants on both dosing schedules, once and twice daily LMWH.
517378|NCT00773968|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
516801|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516802|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516803|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516804|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516805|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516806|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516807|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516808|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516809|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516810|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516811|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516812|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516813|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516814|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516815|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516816|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516817|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516818|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516819|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516820|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516821|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516822|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516823|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516824|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516825|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516826|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516827|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516828|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516829|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516830|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516831|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516832|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516833|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516834|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516835|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517031|NCT00773734|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).
517377|NCT00773955|E1|Reported Event|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
517412|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
516836|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516837|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516838|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516839|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516840|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516841|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516842|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516843|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516844|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516845|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516846|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516847|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516848|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516849|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516850|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517251|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
517252|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516851|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516852|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516853|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516854|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516855|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516856|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516857|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516858|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516859|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516860|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516861|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516862|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516863|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516864|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516865|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517253|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517254|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517918|NCT00775190|E1|Reported Event|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
516866|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516867|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516868|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516869|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516870|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516871|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516872|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516873|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516874|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516875|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516876|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516877|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516878|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516879|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516880|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517255|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
517256|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516881|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516882|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516883|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516884|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516885|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516886|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516887|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516888|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516889|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516890|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516891|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516892|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516893|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516894|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516895|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516896|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516897|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516898|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516899|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516900|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516901|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516902|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516903|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516904|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516905|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516906|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516907|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516908|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516909|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516910|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516911|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516912|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516913|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516914|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516915|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516916|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516917|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516918|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516919|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517257|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516920|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516921|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
516922|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516923|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516924|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516925|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516926|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
516927|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516928|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
516929|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516930|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516931|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
516932|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516933|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
516934|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516935|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516936|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
516937|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516938|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
516939|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
516940|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516941|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
516942|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516943|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
516945|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516946|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516947|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516948|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516949|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516950|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516951|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516952|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516953|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516954|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516955|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516956|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516957|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516958|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516959|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516960|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517258|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517919|NCT00775203|B3|Baseline|Total|Total of all reporting groups
516961|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516962|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516963|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516964|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516965|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516966|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516967|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516968|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516969|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516970|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516971|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516972|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516973|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516974|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516975|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517259|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517260|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
518093|NCT00775463|B2|Baseline|Treprostinil Diethanolamine|intent to treat population
516976|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516977|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516978|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516979|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516980|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516981|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516982|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516983|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516984|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516985|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516986|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516987|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516988|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516989|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516990|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517261|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517262|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517263|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
516991|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516992|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516993|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516994|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
516995|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
516996|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516997|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
516998|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
516999|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517000|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517001|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517002|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517003|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517004|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517005|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517264|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517265|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
518094|NCT00775463|B1|Baseline|Placebo|intent to treat population
517006|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517007|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517008|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517009|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517010|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517011|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517012|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) continued dosing with apremilast 10mg PO BID through Week 52 of the extension phase. Participants who received 10mg PO BID at the end of the extension study were randomly assigned to apremilast 20 mg or 30 mg PO BID during the long term extension study. (LTE).
517013|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517014|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517015|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517016|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
517017|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517018|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517019|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517020|NCT00773734|O1|Outcome|Placebo BID|.Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
517021|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517022|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517023|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517024|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16)
517025|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517026|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517027|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) continued dosing with apremilast 10mg PO BID through Week 52 of the extension phase. Participants who received 10mg PO BID at the end of the extension study were randomly assigned to apremilast 20 mg or 30 mg PO BID during the long term extension study. (LTE).
517028|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517029|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517030|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517032|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517033|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517034|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517035|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517036|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517037|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517038|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517039|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517040|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517041|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517042|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517043|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517044|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517045|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517046|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517266|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517267|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
517408|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
523183|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
517047|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517048|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517049|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517050|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517051|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517052|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517053|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517054|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517055|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517056|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517057|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517058|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517059|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517060|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517061|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517291|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517292|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
523184|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
517062|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517063|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517064|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517065|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517066|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517067|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517068|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517069|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517070|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517071|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517072|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517073|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517074|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517075|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517076|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517293|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast (APR) 10 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16).
517294|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
517409|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
523185|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
517077|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517078|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517079|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517080|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517081|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517082|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517083|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517084|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517085|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517086|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517087|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517088|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517089|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517090|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517091|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517322|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517323|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
523186|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
517092|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517093|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517094|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517095|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517096|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517097|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517098|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517099|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517100|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517101|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517102|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517103|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517104|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517105|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517106|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517324|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517325|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
517410|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
523187|NCT00796224|E2|Reported Event|30 mg/kg Azithromycin IR|
517107|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517108|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517109|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517110|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517111|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517112|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517113|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517114|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517115|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517116|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517117|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517118|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517119|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517120|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517121|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517351|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517352|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
517353|NCT00773734|E7|Reported Event|Apremilast 30mg BID (APR Exposure Period) Years 0-6|Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
517122|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517123|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517124|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517125|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517126|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517127|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517128|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517129|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517130|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517131|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517132|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517133|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517134|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517135|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517136|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517354|NCT00773734|E6|Reported Event|Apremilast 20mg BID (APR Exposure Period) Years 0-6|Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
517355|NCT00773734|E5|Reported Event|Apremilast 10mg BID (APR Exposure Period) Years 0-6|Participants initially randomized to 10 mg PO BID apremilast at Week 0. Participants who were dosed with apremilast 10mg BID in the extension study were randomly assigned to either apremilast 20 mg or 30 mg BID in the long term extension study (LTE).
517137|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517138|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517139|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517140|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517141|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517142|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517143|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517144|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517145|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517146|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517147|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517148|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517149|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517150|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517151|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517356|NCT00773734|E4|Reported Event|Apremilast 30mg BID (Weeks 0-16)|Participants randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)
517357|NCT00773734|E3|Reported Event|Apremilast 20mg BID (Weeks 0-16)|Participants randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)
517358|NCT00773734|E2|Reported Event|Apremilast 10mg BID (Weeks 0-16)|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
518379|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
517152|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517153|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517154|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517155|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517156|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517157|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517158|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517159|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517160|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517161|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517162|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517163|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517164|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517165|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517166|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517359|NCT00773734|E1|Reported Event|Placebo (Weeks 0-16)|Participants randomized to placebo PO BID during the Placebo-controlled Phase
517360|NCT00773786|B1|Baseline|All Study Participants|Participants randomized and received either Tiotropium + Brovana twice daily for 1 week or Tiotropium + placebo twice daily for 1 week.
517361|NCT00773786|P2|Participant Flow|Placebo, Then Arformoterol (Brovana)|Participants first received Tiotropium + Placebo twice daily for 1 week . After a 1 week washout period, they received Tiotropium + Brovana twice daily for 1 week via nebulizer.
517167|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517168|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517169|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517170|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517171|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517172|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517173|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517174|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517175|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517176|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517177|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517178|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517179|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517180|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517181|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517362|NCT00773786|P1|Participant Flow|Tiotropium + Arformoterol (Brovana), Then Tiotropium + Placebo|Participants first received Tiotropium + Brovana twice daily for 1 week via nebulizer. After a 1 week washout period, they received Tiotropium + placebo twice daily for 1 week.
517363|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week
517364|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
523188|NCT00796224|E1|Reported Event|60 mg/kg Azithromycin ER|
517182|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517183|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517184|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517185|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517186|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517187|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517188|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517189|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517190|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517191|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517192|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517193|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517194|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517195|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517196|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517365|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week.
517366|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
517367|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week.
517368|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
517369|NCT00773786|E2|Reported Event|Placebo|Placebo twice daily for 1 week
517197|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517198|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517199|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517200|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517201|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517202|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517203|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517204|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517205|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517206|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517207|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517208|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517209|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517210|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517211|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517370|NCT00773786|E1|Reported Event|Arformoterol|Arformoterol twice daily for 1 week via nebulizer
517371|NCT00773955|B1|Baseline|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
517372|NCT00773955|P1|Participant Flow|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
523189|NCT00796302|B3|Baseline|Total|Total of all reporting groups
517212|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517213|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517214|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517215|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517216|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517217|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517218|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517219|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517220|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517221|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517222|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517223|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517224|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517225|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517226|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517373|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
517374|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
517375|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
517227|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517228|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517229|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517230|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517231|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
517232|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517233|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517234|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517235|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517236|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517237|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517238|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517239|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517240|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517241|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517242|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517243|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517244|NCT00773734|O3|Outcome|Apremilast 30 mg|Participants who were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Active Treatment Phase (Weeks 16-24).
517245|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
517246|NCT00773734|O1|Outcome|Apremilast 10mg|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517247|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517248|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517249|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
517250|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
517411|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517268|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517269|NCT00773734|O4|Outcome|Placebo-Apremilast (APR) 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
517270|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517271|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517272|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517273|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517274|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517275|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517276|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
517277|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517278|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
517279|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517280|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517281|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517282|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517283|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517284|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517285|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
517286|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517287|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
517288|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517289|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517290|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517295|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517296|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
517297|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517298|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517299|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517300|NCT00773734|O4|Outcome|Apremilast 30 mg|Participants were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517301|NCT00773734|O3|Outcome|Apremilast 20mg|Participants were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517302|NCT00773734|O2|Outcome|Apremilast 10mg|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517303|NCT00773734|O1|Outcome|Placebo|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
517304|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
517305|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
517306|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517307|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517308|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517309|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517310|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517311|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517312|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16). .
517313|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517314|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517315|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517316|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
517317|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
517318|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg tablets BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
517319|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517320|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517321|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to APR 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
524408|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
517326|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517327|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
517328|NCT00773734|O3|Outcome|Apremilast 30 mg|Participants who were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Active Treatment Phase (Weeks 16-24).
517329|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
517330|NCT00773734|O1|Outcome|Apremilast 10mg|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517331|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517332|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517333|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517334|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
517335|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
517336|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
517337|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517338|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
517339|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
517340|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517341|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517342|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
517343|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16).
517344|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
517345|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg PO BID during the active treatment phase (Weeks 16-24).
517346|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517347|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517348|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 10 mg BID PO during the Active Treatment Phase (Weeks 16-24).
517349|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
517350|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
517379|NCT00773968|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta (also known as continuous erythropoietin receptor activator [CERA]) once monthly by subcutaneous (SC) injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 micrograms (µg) if the last weekly dose of previous erythropoietin stimulating agent (ESA) (darbepoetin alfa) was less than (<) 40 µg or 40-80 µg or greater than (>) 80 µg, respectively. The doses were adjusted according to individual participant’s hemoglobin (Hb) value.
517380|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
517381|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
517382|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
517383|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
517384|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
517385|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
517386|NCT00773968|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
517387|NCT00774046|B1|Baseline|All Patients|Ara-C Mitoxantrone Etoposide
517388|NCT00774046|P1|Participant Flow|Induction Chemotherapy Followed by Stem Cell Transplant|Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
517389|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
517390|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
517391|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
517392|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
517393|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
517394|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
517395|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
517396|NCT00774046|E1|Reported Event|All Patients|Ara-C Mitoxantrone Etoposide
517397|NCT00774163|B3|Baseline|Total|Total of all reporting groups
517398|NCT00774163|B2|Baseline|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517399|NCT00774163|B1|Baseline|Lactobacillus Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517400|NCT00774163|P2|Participant Flow|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517401|NCT00774163|P1|Participant Flow|Lactobacillus Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517402|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517403|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517404|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517405|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517406|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517407|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
524412|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
517413|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517414|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517416|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517417|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517418|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517419|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517420|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517421|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517422|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517423|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517424|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517425|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517426|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517427|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517428|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517429|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517430|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517431|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517432|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517433|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517434|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517435|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517436|NCT00774163|E2|Reported Event|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
517437|NCT00774163|E1|Reported Event|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
517438|NCT00774267|B5|Baseline|Total|Total of all reporting groups
517439|NCT00774267|B4|Baseline|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517440|NCT00774267|B3|Baseline|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517441|NCT00774267|B2|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517442|NCT00774267|B1|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517443|NCT00774267|P4|Participant Flow|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517719|NCT00774748|O1|Outcome|All Participants|All participants on both a daily and twice daily dosing schedule
525556|NCT00789724|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
517444|NCT00774267|P3|Participant Flow|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517468|NCT00774306|E4|Reported Event|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
518388|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
517445|NCT00774267|P2|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517446|NCT00774267|P1|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517447|NCT00774267|O4|Outcome|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517448|NCT00774267|O3|Outcome|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517449|NCT00774267|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517450|NCT00774267|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517451|NCT00774267|E4|Reported Event|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517452|NCT00774267|E3|Reported Event|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517453|NCT00774267|E2|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517454|NCT00774267|E1|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
517455|NCT00774306|B5|Baseline|Total|Total of all reporting groups
517456|NCT00774306|B4|Baseline|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
517457|NCT00774306|B3|Baseline|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
517458|NCT00774306|B2|Baseline|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.
valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
517459|NCT00774306|B1|Baseline|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses."
517460|NCT00774306|P4|Participant Flow|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
517461|NCT00774306|P3|Participant Flow|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
517462|NCT00774306|P2|Participant Flow|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.
valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
517463|NCT00774306|P1|Participant Flow|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period. Daily dose will be adjusted to maintain levels in the standard therapeutic range of 10-20 mg/dL. Upon discharge, they will remain on the drug in oral form until follow-up with the principal investigator 6 weeks later.
x
x"
517464|NCT00774306|O4|Outcome|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
517465|NCT00774306|O3|Outcome|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
517466|NCT00774306|O2|Outcome|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.
valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
517467|NCT00774306|O1|Outcome|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.
x
x"
517469|NCT00774306|E3|Reported Event|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
517470|NCT00774306|E2|Reported Event|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.
valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
517471|NCT00774306|E1|Reported Event|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.
x
x"
517472|NCT00774397|B8|Baseline|Total|Total of all reporting groups
517473|NCT00774397|B7|Baseline|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517474|NCT00774397|B6|Baseline|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517475|NCT00774397|B5|Baseline|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517476|NCT00774397|B4|Baseline|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517477|NCT00774397|B3|Baseline|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517478|NCT00774397|B2|Baseline|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517479|NCT00774397|B1|Baseline|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517480|NCT00774397|P7|Participant Flow|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517481|NCT00774397|P6|Participant Flow|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517482|NCT00774397|P5|Participant Flow|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517483|NCT00774397|P4|Participant Flow|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517484|NCT00774397|P3|Participant Flow|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517485|NCT00774397|P2|Participant Flow|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517486|NCT00774397|P1|Participant Flow|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV (Pegylated interferon α-2a (Pegasys®)/ Ribavirin (Copegus®)): PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517487|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517488|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517723|NCT00774748|O1|Outcome|All Participants|Both dosing schedules, once and twice daily, all participants.
517489|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
518448|NCT00777062|B3|Baseline|Total|Total of all reporting groups
517490|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517491|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517492|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517493|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517494|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517495|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517496|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517497|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517498|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517499|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517500|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517501|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517502|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517503|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517504|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517505|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517506|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517507|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517508|NCT00774397|O6|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517509|NCT00774397|O5|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517510|NCT00774397|O4|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517511|NCT00774397|O3|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517512|NCT00774397|O2|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517513|NCT00774397|O1|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517514|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517515|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517516|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517517|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517518|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517519|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517520|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517521|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517522|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517523|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517524|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517525|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517526|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517527|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517528|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517529|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517720|NCT00774748|O1|Outcome|Once Daily Dosing|10 participants were placed on an once daily dosing schedule in accordance with their physician approved, standard of care weight specific dosage.
517530|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517531|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517532|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517533|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517534|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517535|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517536|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517537|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517538|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517539|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517540|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517541|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517542|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517543|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517544|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517545|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517546|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517547|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517548|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517549|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517550|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517551|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517552|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517553|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517554|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517555|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517556|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517557|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517558|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517559|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517560|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517561|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517562|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517563|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517564|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517565|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517566|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517567|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517568|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517569|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517570|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517571|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517572|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517573|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517574|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517575|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517576|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517577|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517578|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517579|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517580|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517581|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517582|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517583|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517584|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517585|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517586|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517587|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517588|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517589|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517590|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517591|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517592|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517593|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517594|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517595|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517596|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517597|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517598|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517599|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517600|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517601|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517602|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517603|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517604|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517605|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517606|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517607|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517608|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517609|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517610|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517611|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517612|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517613|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517614|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517615|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517616|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517617|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517618|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517619|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517620|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517621|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517622|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517623|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517624|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517625|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517626|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517627|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517628|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517629|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517630|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517631|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517632|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517633|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517634|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517635|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517636|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517637|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517638|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517639|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517640|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517641|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517642|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517643|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517644|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517645|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517646|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517647|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517648|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517649|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517650|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517651|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517652|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517653|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517654|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517655|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517656|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517657|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517658|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517659|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517660|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517661|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517662|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517663|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517664|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517665|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517666|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517667|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517668|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517669|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517670|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517671|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517672|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517673|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517674|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517675|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517676|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517677|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517678|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517679|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517680|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517681|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517682|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517683|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517684|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517685|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517686|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517687|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517688|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517689|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517690|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517691|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517692|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517693|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517694|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517695|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517696|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517697|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517698|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517699|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517700|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517701|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517702|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517703|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517704|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517705|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517706|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517707|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517708|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517709|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517710|NCT00774397|E7|Reported Event|240mg BID/LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517711|NCT00774397|E6|Reported Event|240mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517712|NCT00774397|E5|Reported Event|240mg QD/LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517713|NCT00774397|E4|Reported Event|240mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517714|NCT00774397|E3|Reported Event|240mg QD/LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517715|NCT00774397|E2|Reported Event|120mg QD/LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517716|NCT00774397|E1|Reported Event|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
517717|NCT00774748|B1|Baseline|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
517718|NCT00774748|P1|Participant Flow|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
518380|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
517724|NCT00774748|E1|Reported Event|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
518199|NCT00776230|B2|Baseline|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
517725|NCT00774787|B1|Baseline|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
517726|NCT00774787|P1|Participant Flow|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
517727|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
517728|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
517729|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
517730|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
517731|NCT00774787|E1|Reported Event|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
517732|NCT00774800|B1|Baseline|Overall Study|"Humalog+recombinant human hyaluronidase PH20 (rHuPH20): Up to 3 dose-finding (DF) visits (each visit separated by 3-10 days [d]) until an appropriate dose of Humalog was identified. For each DF visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously (SC) per unit of Humalog, corresponding to a mass concentration (conc) of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final conc of 91 U/mL of Humalog)
Humalog alone: After a 3-10 d washout (wo), a single SC injection of the appropriate identified dose of Humalog was delivered
Humulin-R+rHuPH20: After a 3-10 d wo, up to 2 DF visits (both visits separated by 3-10 d) until an appropriate dose of Humulin-R was identified. For each DF visit, a total of 24 U of rHuPH20 was injected SC per unit of Humulin-R, corresponding to a mass conc of 20.0 μg/mL rHuPH20 (at final conc of 100 U/mL of Humulin-R)
Humulin-R alone: After a 3-10 d wo, a single SC injection of the appropriate identified dose of Humulin-R was delivered"
517733|NCT00774800|P1|Participant Flow|First Humalog+PH20, Then Humalog, Humulin-R+PH20, Humulin-R|"Humalog + Recombinant human hyaluronidase PH20 (rHuPH20) (Intervention 1): 24 units (U) of rHuPH20 per unit of Humalog, injected subcutaneously (SC), for up to 3 visits until an appropriate dose was identified.
Humalog alone (Intervention 2): a single SC injection of the appropriate identified dose of Humalog, delivered before a liquid meal.
Humulin-R + rHuPH20 (Intervention 3): 24 U of rHuPH20 per unit of Humulin-R, injected SC, for up to 2 visits until an appropriate dose was identified.
Humulin-R alone (Intervention 4): a single SC injection of the appropriate identified dose of Humulin-R, delivered before a liquid meal.
Appropriate dose of either Humalog or Humulin-R was that at which blood glucose following a liquid meal was <160 milligrams per deciliter (mg/dL) for more than 30 minutes during the first 4 hours after injection and never fell below 60 mg/dL.
All dose finding visits and interventions were separated by 3-10 days."
517734|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
517735|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
517736|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
517737|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
517738|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
517739|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
517740|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
517831|NCT00774930|E3|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase)|All 101 subjects in the IOL phase received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks (56 and 45 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
526860|NCT00792116|P2|Participant Flow|Non-Gum Chewing|
517868|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517741|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
517742|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
517743|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
517744|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
517745|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
517746|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
517747|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
517748|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
517749|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
517750|NCT00774800|E4|Reported Event|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
517751|NCT00774800|E3|Reported Event|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
517752|NCT00774800|E2|Reported Event|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
517753|NCT00774800|E1|Reported Event|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
517754|NCT00774852|B3|Baseline|Total|Total of all reporting groups
517755|NCT00774852|B2|Baseline|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517756|NCT00774852|B1|Baseline|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517832|NCT00774930|E2|Reported Event|Placebo (DB Phase)|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
517833|NCT00774930|E1|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase)|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
517834|NCT00774995|B5|Baseline|Total|Total of all reporting groups
517757|NCT00774852|P2|Participant Flow|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517758|NCT00774852|P1|Participant Flow|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517759|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
517760|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
517761|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
517762|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
517763|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
517764|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
517765|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517766|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517767|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517768|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517835|NCT00774995|B4|Baseline|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517769|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517770|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517771|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517772|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517773|NCT00774852|O6|Outcome|Week 24 No Response: Placebo|At Week 28 participants assigned to Placebo group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
517774|NCT00774852|O5|Outcome|Week 24 No Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
517775|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
517776|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
517777|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
517778|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
517779|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517780|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517920|NCT00775203|B2|Baseline|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517781|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517782|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517783|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517784|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517785|NCT00774852|O2|Outcome|Week 24 Non-Responder Who Continued Treatment: Placebo|Participants who were in the placebo arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
517786|NCT00774852|O1|Outcome|Week 24 Non-Responder Who Continued Treatment: Abatacept|Participants who were in the abatacept arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
517787|NCT00774852|O2|Outcome|Week 24 Non-Responder: Placebo|Participants who were in the placebo arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
517788|NCT00774852|O1|Outcome|Week 24 Non-Responder: Abatacept|Participants who were in the abatacept arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
517789|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517790|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517836|NCT00774995|B3|Baseline|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517837|NCT00774995|B2|Baseline|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517840|NCT00774995|P3|Participant Flow|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517791|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517792|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517793|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
517794|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
517795|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
517796|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
517797|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
517798|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
517799|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517800|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517801|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517802|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517838|NCT00774995|B1|Baseline|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517803|NCT00774852|E2|Reported Event|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
517804|NCT00774852|E1|Reported Event|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
517805|NCT00774930|B3|Baseline|Total|Total of all reporting groups
517806|NCT00774930|B2|Baseline|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
517807|NCT00774930|B1|Baseline|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.
517808|NCT00774930|P2|Participant Flow|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
517809|NCT00774930|P1|Participant Flow|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the initial open label (IOL) phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the long term open label extension (LTOLE) phase.
517810|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
517811|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
517812|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
517813|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
517814|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
517815|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
517816|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
517817|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
517818|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
517819|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
517820|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
517821|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
517822|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
517823|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
517824|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
517825|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
517826|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
517827|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
517828|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
517829|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
517830|NCT00774930|E4|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)|All 57 subjects in the LTOLE phase received further deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (32 and 25 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
517839|NCT00774995|P4|Participant Flow|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517841|NCT00774995|P2|Participant Flow|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517842|NCT00774995|P1|Participant Flow|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517843|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517844|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517845|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517846|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517847|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517848|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517849|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517850|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517851|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517852|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517853|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517854|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517855|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517856|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517857|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517858|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517859|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517860|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517861|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517862|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517863|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517864|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517865|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517866|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517867|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517917|NCT00775190|E2|Reported Event|Trinessa™|Trinessa: generic oral contraceptive
517869|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517870|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517871|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517872|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517873|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517874|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517875|NCT00774995|E4|Reported Event|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517876|NCT00774995|E3|Reported Event|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517877|NCT00774995|E2|Reported Event|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517878|NCT00774995|E1|Reported Event|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
517879|NCT00775021|B1|Baseline|Total Participants|Total number of participants that completed the study.
517880|NCT00775021|P2|Participant Flow|Nelfilcon A/Etafilcon A|nelfilcon A contact lens worn first and etafilcon A contact lens second.
517881|NCT00775021|P1|Participant Flow|Etafilcon A/Nelfilcon A|etafilcon A contact lens worn first and nelfilcon A contact lens worn second
517882|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
517883|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
517884|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
517885|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
517886|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
517887|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
517888|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
517889|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
517890|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
517891|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
517892|NCT00775021|E2|Reported Event|Nelfilcon A|nelfilcon A contact lenses.
517893|NCT00775021|E1|Reported Event|Etafilcon A|etafilcon A contact lenses
517894|NCT00775190|B3|Baseline|Total|Total of all reporting groups
517895|NCT00775190|B2|Baseline|Trinessa™|Trinessa: generic oral contraceptive
517896|NCT00775190|B1|Baseline|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
517897|NCT00775190|P2|Participant Flow|Trinessa™|Trinessa: generic oral contraceptive
517898|NCT00775190|P1|Participant Flow|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
517899|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
517900|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
517901|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
517902|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
517903|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
517904|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
517905|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
517906|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
517907|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
517908|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
517909|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
517910|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
517911|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
517912|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
517913|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
517914|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
517915|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
517916|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
517942|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
518268|NCT00776919|B5|Baseline|Total|Total of all reporting groups
517921|NCT00775203|B1|Baseline|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517922|NCT00775203|P2|Participant Flow|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517923|NCT00775203|P1|Participant Flow|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517924|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517925|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517926|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517927|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517928|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517929|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517930|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517931|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517932|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517933|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517934|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517935|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517936|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517937|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517938|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517939|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517940|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517941|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
518054|NCT00769860|E2|Reported Event|Placebo|Matched placebo pills, 100 mg TID for 4 months
517943|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517944|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517945|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517946|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517947|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517948|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517949|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517950|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517951|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517952|NCT00775203|E2|Reported Event|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
517953|NCT00775203|E1|Reported Event|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
517954|NCT00775229|B3|Baseline|Total|Total of all reporting groups
517955|NCT00775229|B2|Baseline|Placebo|"Placebo
Placebo : pill, by mouth, daily"
517956|NCT00775229|B1|Baseline|Naltrexone|"Naltrexone
Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
517957|NCT00775229|P2|Participant Flow|Placebo|"Placebo
Placebo : pill, by mouth, daily"
517958|NCT00775229|P1|Participant Flow|Naltrexone|"Naltrexone
Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
517959|NCT00775229|O2|Outcome|Placebo|"Placebo
Placebo : pill, by mouth, daily"
517960|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone
Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
517961|NCT00775229|O2|Outcome|Placebo|"Placebo
Placebo : pill, by mouth, daily"
517962|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone
Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
517963|NCT00775229|O2|Outcome|Placebo|"Placebo
Placebo : pill, by mouth, daily"
517964|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone
Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
517965|NCT00775229|E2|Reported Event|Placebo|"Placebo
Placebo : pill, by mouth, daily"
517966|NCT00775229|E1|Reported Event|Naltrexone|"Naltrexone
Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
517967|NCT00775346|B1|Baseline|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
517968|NCT00775346|P1|Participant Flow|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
517969|NCT00775346|O1|Outcome|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
517970|NCT00775346|E1|Reported Event|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
517971|NCT00775411|B1|Baseline|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
517972|NCT00775411|P1|Participant Flow|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
517973|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
517974|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
518198|NCT00776230|B3|Baseline|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
517975|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
517976|NCT00775411|E1|Reported Event|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
517977|NCT00775437|B1|Baseline|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517978|NCT00775437|P1|Participant Flow|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517979|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517980|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517981|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517982|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517983|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517984|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517985|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517986|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517987|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517988|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517989|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518055|NCT00769860|E1|Reported Event|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518056|NCT00775450|B6|Baseline|Total|Total of all reporting groups
517990|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517991|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517992|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517993|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517994|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517995|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517996|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517997|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517998|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
517999|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518000|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518001|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518002|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518003|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518057|NCT00775450|B5|Baseline|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
518004|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518005|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518006|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518007|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518008|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518009|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518010|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518011|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518012|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518013|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518014|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518015|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518016|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518017|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518058|NCT00775450|B4|Baseline|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
518018|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518019|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518020|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518021|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518022|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518023|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518024|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518025|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518026|NCT00775437|E1|Reported Event|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
518027|NCT00769860|B3|Baseline|Total|Total of all reporting groups
518028|NCT00769860|B2|Baseline|Placebo|Matched placebo pills, 100 mg TID for 4 months
518029|NCT00769860|B1|Baseline|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518030|NCT00769860|P2|Participant Flow|Placebo|Matched placebo pills, 100 mg TID for 4 months
518031|NCT00769860|P1|Participant Flow|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518032|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
518033|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518034|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
518035|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518036|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
518037|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518038|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
518039|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518040|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
518041|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518042|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
518043|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518044|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
518045|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518046|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
518047|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518048|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
518049|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518050|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
518051|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518052|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
518053|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
518059|NCT00775450|B3|Baseline|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
518060|NCT00775450|B2|Baseline|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
518061|NCT00775450|B1|Baseline|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
518062|NCT00775450|P5|Participant Flow|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
518063|NCT00775450|P4|Participant Flow|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
518064|NCT00775450|P3|Participant Flow|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
518065|NCT00775450|P2|Participant Flow|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
518066|NCT00775450|P1|Participant Flow|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
518067|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
518068|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
518069|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
518070|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
518071|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
518072|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
518073|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
518074|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
518075|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
518076|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
518077|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
518078|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
518079|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
518080|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
518081|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
518082|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
518083|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
518084|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
518085|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
518086|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
518087|NCT00775450|E5|Reported Event|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
518088|NCT00775450|E4|Reported Event|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
518089|NCT00775450|E3|Reported Event|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
518090|NCT00775450|E2|Reported Event|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
518091|NCT00775450|E1|Reported Event|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
518092|NCT00775463|B3|Baseline|Total|Total of all reporting groups
518095|NCT00775463|P2|Participant Flow|Treprostinil Diethanolamine|All subejcts who recieved at least one dose of study drug. One subject in the treprostinil diethanolamine treatment group was randomized, withdrew consent and exited the study prior to taking any study medication and is not included in the analysis summary.
518096|NCT00775463|P1|Participant Flow|Placebo|All subjects who recieved at least one dose of study drug.
518097|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
518098|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
518099|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
518100|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
518101|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
518102|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
518103|NCT00775463|O6|Outcome|Treprostinil Diethanolamine- Overall Disease Status Response|Treprostinil diethanolamine intent to treat population
518104|NCT00775463|O5|Outcome|Placebo- Overall Disease Status Response|Placebo intent to treat population
518105|NCT00775463|O4|Outcome|Treprostinil Diethanolamine- Raynaud's Phenomenon Response|Treprostinil diethanolamine intent to treat population
518106|NCT00775463|O3|Outcome|Placebo- Raynaud's Phenomenon Response|Placebo intent to treat population
518107|NCT00775463|O2|Outcome|Treprostinil Diethanolamine- Digital Ulcer Response|Treprostinil diethanolamine intent to treat population
518108|NCT00775463|O1|Outcome|Placebo- Digital Ulcer Response|Placebo intent to treat population
518109|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
518110|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
518111|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
518112|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
518113|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
518114|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
518115|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
518116|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
518117|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
518118|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
518119|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
518120|NCT00775463|O1|Outcome|Placebo|placebo intent to treat population
518121|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
518122|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
518123|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
518124|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
518125|NCT00775463|E2|Reported Event|Treprostinil Diethanolamine|
518126|NCT00775463|E1|Reported Event|Placebo|
518127|NCT00775528|B1|Baseline|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
518128|NCT00775528|P1|Participant Flow|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
518129|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
518130|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
518131|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
518132|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
518133|NCT00775528|E1|Reported Event|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
518134|NCT00775593|B1|Baseline|Study Group|Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
518135|NCT00775593|P1|Participant Flow|Study Group|Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
518136|NCT00775593|O1|Outcome|Study Group|Evaluable patients
518137|NCT00775593|O1|Outcome|Study Group|Evaluable patients
518138|NCT00775593|O1|Outcome|Study Group|Evaluable patients
518139|NCT00775593|O1|Outcome|Study Group|Evaluable patients
518140|NCT00775593|E1|Reported Event|Study Group|Evaluable patients
518141|NCT00775606|B3|Baseline|Total|Total of all reporting groups
518142|NCT00775606|B2|Baseline|ARM B|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
518143|NCT00775606|B1|Baseline|ARM A|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
518144|NCT00775606|P2|Participant Flow|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
518145|NCT00775606|P1|Participant Flow|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
518146|NCT00775606|O2|Outcome|ARM B|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
518147|NCT00775606|O1|Outcome|ARM A|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
518148|NCT00775606|O2|Outcome|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
518149|NCT00775606|O1|Outcome|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
518150|NCT00775606|O2|Outcome|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
518151|NCT00775606|O1|Outcome|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
518152|NCT00775606|E2|Reported Event|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
518153|NCT00775606|E1|Reported Event|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
518154|NCT00775645|B3|Baseline|Total|Total of all reporting groups
518155|NCT00775645|B2|Baseline|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
518156|NCT00775645|B1|Baseline|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
518157|NCT00775645|P2|Participant Flow|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
518158|NCT00775645|P1|Participant Flow|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
518159|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
518160|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
518161|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
518162|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
518163|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
518164|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
518165|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
518166|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
518167|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
518168|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
518169|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
518170|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
518171|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
518172|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
518173|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
518174|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
518175|NCT00775645|E2|Reported Event|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
518176|NCT00775645|E1|Reported Event|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
518177|NCT00775658|B1|Baseline|All Participants|Includes both groups of participants
518178|NCT00775658|P2|Participant Flow|Placebo Then Olopatadine|participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
518179|NCT00775658|P1|Participant Flow|Olopatadine Then Placebo|participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
518180|NCT00775658|O2|Outcome|Placebo|
518181|NCT00775658|O1|Outcome|Olopatadine|double blind crossover
518182|NCT00775658|O2|Outcome|Placebo|
518183|NCT00775658|O1|Outcome|Olopatadine|double blind crossover
518184|NCT00775658|E2|Reported Event|Placebo|
518185|NCT00775658|E1|Reported Event|Olopatadine|double blind crossover
518186|NCT00775671|B3|Baseline|Total|Total of all reporting groups
518187|NCT00775671|B2|Baseline|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
518188|NCT00775671|B1|Baseline|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
518189|NCT00775671|P2|Participant Flow|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
518190|NCT00775671|P1|Participant Flow|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
518191|NCT00775671|O2|Outcome|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
518192|NCT00775671|O1|Outcome|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
518193|NCT00775671|O2|Outcome|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
518194|NCT00775671|O1|Outcome|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
518195|NCT00775671|E2|Reported Event|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
518196|NCT00775671|E1|Reported Event|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
518197|NCT00776230|B4|Baseline|Total|Total of all reporting groups
518381|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518200|NCT00776230|B1|Baseline|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
518201|NCT00776230|P3|Participant Flow|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
518202|NCT00776230|P2|Participant Flow|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
518203|NCT00776230|P1|Participant Flow|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
518204|NCT00776230|O3|Outcome|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
518205|NCT00776230|O2|Outcome|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
518206|NCT00776230|O1|Outcome|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
518207|NCT00776230|E3|Reported Event|IC51 Cohort 3|
518208|NCT00776230|E2|Reported Event|IC51 Cohort 2|
518209|NCT00776230|E1|Reported Event|IC51 Cohort 1|
518210|NCT00776295|B1|Baseline|p53 Vaccination|Dendritic cell p53 vaccination
518211|NCT00776295|P1|Participant Flow|p53 Vaccination|Dendritic cell p53 vaccination
518212|NCT00776295|O1|Outcome|p53 Vaccination|Dendritic cell p53 vaccination
518213|NCT00776295|O1|Outcome|p53 Vaccination|Dendritic cell p53 vaccination
518214|NCT00776295|E1|Reported Event|Biological/Vaccine|Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expaned T-lymphocytes
518215|NCT00776555|B3|Baseline|Total|Total of all reporting groups
518216|NCT00776555|B2|Baseline|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
518217|NCT00776555|B1|Baseline|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
518218|NCT00776555|P2|Participant Flow|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
518219|NCT00776555|P1|Participant Flow|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
518220|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
518221|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
518222|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
518223|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
518224|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
518225|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
518226|NCT00776555|E2|Reported Event|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
518227|NCT00776555|E1|Reported Event|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
518228|NCT00776594|B3|Baseline|Total|Total of all reporting groups
518229|NCT00776594|B2|Baseline|Androgen Deprivation Therapy Alone|"Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months"
518230|NCT00776594|B1|Baseline|Androgen Deprivation Therapy Plus Bevacizumab|"Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
518231|NCT00776594|P2|Participant Flow|Androgen Deprivation Therapy Alone|"Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months"
518232|NCT00776594|P1|Participant Flow|Androgen Deprivation Therapy Plus Bevacizumab|"Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
518233|NCT00776594|O2|Outcome|Leptin in Patients Treated With ADT Alone|Leptin in patients with sample available treated with ADT alone
526861|NCT00792116|P1|Participant Flow|Gum Chewing|
518234|NCT00776594|O1|Outcome|Leptin Level in Patients Treated With ADT+Bev|Leptin level in patients with sample available treated with ADT+bev
518386|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518235|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months"
518236|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
518237|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months"
518238|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
518239|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months"
518240|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
518241|NCT00776594|E2|Reported Event|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months
bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
518242|NCT00776594|E1|Reported Event|Group 2|"Androgen Deprivation Therapy Alone
Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
bicalutamide: 50mg orally daily for 6 months"
518243|NCT00776659|B1|Baseline|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
518244|NCT00776659|P1|Participant Flow|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
518245|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
518246|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
518247|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
518248|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
518249|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
518250|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
518251|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
518252|NCT00776659|E1|Reported Event|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
518253|NCT00776789|B3|Baseline|Total|Total of all reporting groups
518254|NCT00776789|B2|Baseline|Control Group|baby will be kept by the mothers side and not given skin to skin contact
518255|NCT00776789|B1|Baseline|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
518256|NCT00776789|P2|Participant Flow|Control Group|baby will be kept by the mothers side and not given skin to skin contact
518257|NCT00776789|P1|Participant Flow|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
518258|NCT00776789|O2|Outcome|Control Group|baby will be kept by the mothers side and not given skin to skin contact
518259|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
518260|NCT00776789|O2|Outcome|Control Group|Babies will be kept by the mothers side and not given skin to skin contact
518261|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
518262|NCT00776789|O2|Outcome|Control Group|baby will be kept by the mothers side and not given skin to skin contact
518263|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
518264|NCT00776789|O2|Outcome|Control Group|Baby will be kept by the mothers side and not given skin to skin contact
518265|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
518266|NCT00776789|E2|Reported Event|Control Group|baby will be kept by the mothers side and not given skin to skin contact
518267|NCT00776789|E1|Reported Event|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
518269|NCT00776919|B4|Baseline|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518270|NCT00776919|B3|Baseline|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518271|NCT00776919|B2|Baseline|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518272|NCT00776919|B1|Baseline|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518273|NCT00776919|P4|Participant Flow|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518274|NCT00776919|P3|Participant Flow|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518275|NCT00776919|P2|Participant Flow|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518276|NCT00776919|P1|Participant Flow|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518277|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518278|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518279|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518280|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518281|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518282|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518283|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518284|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518285|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518286|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518287|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518288|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518289|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518290|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518291|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518292|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518293|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518294|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518295|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518296|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518382|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518297|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518298|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518299|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518300|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518301|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518302|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518303|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518304|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518305|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518306|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518307|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518308|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518309|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518310|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518311|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518312|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518313|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518314|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518315|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518316|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518317|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518318|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518319|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518320|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518321|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518322|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518323|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518324|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518325|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518383|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518326|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518387|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518327|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518328|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518329|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518330|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518331|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518332|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518333|NCT00776919|E4|Reported Event|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518334|NCT00776919|E3|Reported Event|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518335|NCT00776919|E2|Reported Event|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518336|NCT00776919|E1|Reported Event|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
518337|NCT00776984|B3|Baseline|Total|Total of all reporting groups
518338|NCT00776984|B2|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518339|NCT00776984|B1|Baseline|Placebo|Patients treated with matching placebo
518340|NCT00776984|P2|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518341|NCT00776984|P1|Participant Flow|Placebo|Patients treated with matching placebo
518342|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518343|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518344|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518345|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518346|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518347|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518348|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518349|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518350|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518351|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518352|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518353|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518354|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518355|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518356|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518357|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518358|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518359|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518360|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518361|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518362|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518363|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518364|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518365|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518366|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518367|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518368|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518369|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518370|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518371|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518372|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518373|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518374|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518375|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518376|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518377|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518378|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
526862|NCT00792116|O2|Outcome|Non-Gum Chewing|
518384|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518385|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518389|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518390|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518391|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518392|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518393|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518394|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518395|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518396|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518397|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518398|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518399|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518400|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518401|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518402|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518403|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518404|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518405|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518406|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518407|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
518408|NCT00776984|E2|Reported Event|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
518409|NCT00776984|E1|Reported Event|Placebo|Patients treated with matching placebo
518410|NCT00776997|B1|Baseline|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
518411|NCT00776997|P1|Participant Flow|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
518412|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
518413|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
518414|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
518415|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
518416|NCT00776997|E1|Reported Event|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
518417|NCT00777023|B4|Baseline|Total|Total of all reporting groups
518418|NCT00777023|B3|Baseline|Sugar Pill|Placebo 1200 mg or 1800 mg
518419|NCT00777023|B2|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
518420|NCT00777023|B1|Baseline|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
518421|NCT00777023|P3|Participant Flow|Sugar Pill|Placebo 1200 mg or 1800 mg
518422|NCT00777023|P2|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
518423|NCT00777023|P1|Participant Flow|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
518424|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
518425|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
518426|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
518427|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
518428|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
518429|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
518430|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
518431|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
518432|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
518433|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
518434|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
518435|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
518436|NCT00777023|E3|Reported Event|Sugar Pill|Placebo 1200 mg or 1800 mg
518437|NCT00777023|E2|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
518438|NCT00777023|E1|Reported Event|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
518439|NCT00777049|B3|Baseline|Total|Total of all reporting groups
518440|NCT00777049|B2|Baseline|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
518441|NCT00777049|B1|Baseline|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
518442|NCT00777049|P2|Participant Flow|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
518443|NCT00777049|P1|Participant Flow|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
518444|NCT00777049|O2|Outcome|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
518445|NCT00777049|O1|Outcome|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
518446|NCT00777049|E2|Reported Event|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
518447|NCT00777049|E1|Reported Event|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
518449|NCT00777062|B2|Baseline|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
518450|NCT00777062|B1|Baseline|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
518451|NCT00777062|P2|Participant Flow|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
518452|NCT00777062|P1|Participant Flow|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
518453|NCT00777062|O2|Outcome|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
518454|NCT00777062|O1|Outcome|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
518455|NCT00777062|O2|Outcome|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
518456|NCT00777062|O1|Outcome|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
518457|NCT00777062|E2|Reported Event|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
518458|NCT00777062|E1|Reported Event|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
518459|NCT00777153|B4|Baseline|Total|Total of all reporting groups
518460|NCT00777153|B3|Baseline|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
518461|NCT00777153|B2|Baseline|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
518462|NCT00777153|B1|Baseline|Cediranib 30mg|Cediranib 30mg/Day
518463|NCT00777153|P3|Participant Flow|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
518464|NCT00777153|P2|Participant Flow|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
518465|NCT00777153|P1|Participant Flow|Cediranib 30mg|Cediranib 30mg/Day
518466|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
518467|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 119mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
518468|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
518469|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
518470|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
518471|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
518472|NCT00777153|O3|Outcome|Lomustine 100mg|Lomustine 110mg/m2/Day + Placebo cediranib
518473|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 100mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
518474|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
518475|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
518476|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
518477|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
518478|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
518479|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
518480|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
518481|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
518482|NCT00777153|O2|Outcome|Cediranib 20mg+ Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
518483|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
518484|NCT00777153|E3|Reported Event|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
518485|NCT00777153|E2|Reported Event|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
518486|NCT00777153|E1|Reported Event|Cediranib 30mg|Cediranib 30mg/Day
518487|NCT00777179|B3|Baseline|Total|Total of all reporting groups
518488|NCT00777179|B2|Baseline|Placebo|Matching Placebo
518489|NCT00777179|B1|Baseline|Vandetanib|Vandetanib 300 mg, orally, once daily
518490|NCT00777179|P2|Participant Flow|Placebo|Matching Placebo
518491|NCT00777179|P1|Participant Flow|Vandetanib|Vandetanib 300 mg, orally, once daily
518492|NCT00777179|O2|Outcome|Placebo|Matching Placebo
518493|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
518494|NCT00777179|O2|Outcome|Placebo|Matching Placebo
518495|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
518496|NCT00777179|O2|Outcome|Placebo|Matching Placebo
518497|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
518498|NCT00777179|O2|Outcome|Placebo|Matching Placebo
518499|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
518500|NCT00777179|O2|Outcome|Placebo|Matching Placebo
518501|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
518502|NCT00777179|E2|Reported Event|Placebo|Matching Placebo
518503|NCT00777179|E1|Reported Event|Vandetanib|Vandetanib 300 mg, orally, once daily
518504|NCT00777205|B3|Baseline|Total|Total of all reporting groups
518518|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518571|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
518572|NCT00777608|E2|Reported Event|Placebo|Participants were randomized to placebo for 84 days
518573|NCT00777608|E1|Reported Event|Donezepil 5-10 mg|Participants were randomized to donepezil for 84 days
518574|NCT00777634|B3|Baseline|Total|Total of all reporting groups
518575|NCT00777634|B2|Baseline|Without BED|Individuals who do not meet criteria for binge eating disorder.
518576|NCT00777634|B1|Baseline|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
518577|NCT00777634|P2|Participant Flow|Without BED|Individuals who do not meet criteria for binge eating disorder.
518578|NCT00777634|P1|Participant Flow|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
518505|NCT00777205|B2|Baseline|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518506|NCT00777205|B1|Baseline|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518507|NCT00777205|P2|Participant Flow|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518508|NCT00777205|P1|Participant Flow|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
518509|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518510|NCT00777205|O1|Outcome|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
518511|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518512|NCT00777205|O1|Outcome|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
518513|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518514|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518515|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518516|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518517|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518570|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
526863|NCT00792116|O1|Outcome|Gum Chewing|
518519|NCT00777205|E2|Reported Event|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
518520|NCT00777205|E1|Reported Event|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
518521|NCT00777257|B4|Baseline|Total|Total of all reporting groups
518522|NCT00777257|B3|Baseline|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
518523|NCT00777257|B2|Baseline|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
518524|NCT00777257|B1|Baseline|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
518525|NCT00777257|P3|Participant Flow|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
518526|NCT00777257|P2|Participant Flow|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
518527|NCT00777257|P1|Participant Flow|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
518528|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
518529|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
518530|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
518531|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
518532|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
518533|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
518534|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
518535|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
518536|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
518537|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
518538|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
518539|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
518540|NCT00777257|E3|Reported Event|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
518541|NCT00777257|E2|Reported Event|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
518542|NCT00777257|E1|Reported Event|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
518543|NCT00777335|B3|Baseline|Total|Total of all reporting groups
518544|NCT00777335|B2|Baseline|Panobinostat Oral|
518545|NCT00777335|B1|Baseline|Panobinostat Intra-venous (i.v.)|
518546|NCT00777335|P2|Participant Flow|Panobinostat Oral|
518547|NCT00777335|P1|Participant Flow|Panobinostat Intra-venous (i.v.)|
518548|NCT00777335|O2|Outcome|Panobinostat Oral|
518549|NCT00777335|O1|Outcome|Panobinostat Intra-venous (i.v.)|
518550|NCT00777335|O2|Outcome|Panobinostat Oral|
518551|NCT00777335|O1|Outcome|Panobinostat Intra-venous (i.v.)|
518552|NCT00777335|E2|Reported Event|Panobinostat Oral|
518553|NCT00777335|E1|Reported Event|Panobinostat Intra-venous (i.v.)|
518554|NCT00777556|B1|Baseline|DR-104|One tablet for emergency contraception
518555|NCT00777556|P1|Participant Flow|DR-104|One tablet for emergency contraception
518556|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
518557|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
518558|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
518559|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
518560|NCT00777556|E1|Reported Event|DR-104|One tablet for emergency contraception
518561|NCT00777608|B3|Baseline|Total|Total of all reporting groups
518562|NCT00777608|B2|Baseline|Placebo|Participants were randomized to placebo for 84 days
518563|NCT00777608|B1|Baseline|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
518564|NCT00777608|P2|Participant Flow|Placebo|Participants were randomized to placebo for 84 days
518565|NCT00777608|P1|Participant Flow|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
518566|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
518567|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
518568|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
518569|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
518579|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
518580|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
518581|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
518582|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
518583|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
518584|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
518585|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
518586|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
518587|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
518588|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
518589|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
518590|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
518591|NCT00777634|E2|Reported Event|Without BED|Individuals who do not meet criteria for binge eating disorder.
518592|NCT00777634|E1|Reported Event|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
518593|NCT00777764|B3|Baseline|Total|Total of all reporting groups
518594|NCT00777764|B2|Baseline|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.
Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
Dilutions of omalizumab and its excipients were made in saline solution."
518595|NCT00777764|B1|Baseline|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.
Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
518596|NCT00777764|P2|Participant Flow|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.
Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
Dilutions of omalizumab and its excipients were made in saline solution."
518597|NCT00777764|P1|Participant Flow|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.
Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
518598|NCT00777764|O1|Outcome|Patients With Allergic Asthma|
518599|NCT00777764|O1|Outcome|Healthy Subjects|
518600|NCT00777764|O2|Outcome|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.
Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
Dilutions of omalizumab and its excipients were made in saline solution."
518601|NCT00777764|O1|Outcome|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.
Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
518652|NCT00777803|E2|Reported Event|OnabotulinumtoxinA (Vistabel®)|
518653|NCT00777803|E1|Reported Event|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518733|NCT00778167|P1|Participant Flow|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
518654|NCT00777855|B1|Baseline|Entire Study Population|Includes participants randomized to receive warfarin alone then warfarin+rifampin, and those randomized to receive warfarin+rifampin then warfarin alone in the crossover design
518734|NCT00778167|O3|Outcome|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
520433|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
518602|NCT00777764|O2|Outcome|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.
Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
Dilutions of omalizumab and its excipients were made in saline solution."
518603|NCT00777764|O1|Outcome|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.
Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
518604|NCT00777764|E2|Reported Event|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.
Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
Dilutions of omalizumab and its excipients were made in saline solution."
518605|NCT00777764|E1|Reported Event|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.
Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
518606|NCT00777790|B4|Baseline|Total|Total of all reporting groups
518607|NCT00777790|B3|Baseline|Control Group|Meningococcal vaccine-naïve subjects
518608|NCT00777790|B2|Baseline|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
518609|NCT00777790|B1|Baseline|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
518610|NCT00777790|P3|Participant Flow|Control Group|Meningococcal vaccine-naïve subjects
518611|NCT00777790|P2|Participant Flow|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
518612|NCT00777790|P1|Participant Flow|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
518613|NCT00777790|O3|Outcome|Control Group|Meningococcal vaccine-naïve subjects
518614|NCT00777790|O2|Outcome|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
518615|NCT00777790|O1|Outcome|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
518616|NCT00777790|E3|Reported Event|Control Group|Meningococcal vaccine-naïve subjects
518617|NCT00777790|E2|Reported Event|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
518618|NCT00777790|E1|Reported Event|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
518619|NCT00777803|B3|Baseline|Total|Total of all reporting groups
518620|NCT00777803|B2|Baseline|OnabotulinumtoxinA (Vistabel®)|
518621|NCT00777803|B1|Baseline|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518622|NCT00777803|P2|Participant Flow|OnabotulinumtoxinA (Vistabel®)|
518623|NCT00777803|P1|Participant Flow|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518624|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518625|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518626|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518627|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518628|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518629|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518630|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518631|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518632|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518633|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518634|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518635|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518636|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518637|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518638|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518639|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518640|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518641|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518642|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518643|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518644|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518645|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518646|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518647|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518648|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518649|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518650|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
518651|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
518655|NCT00777855|P2|Participant Flow|Warfarin+Rifampin First, Then Warfarin Alone|In a randomized, single-dose, two-period, crossover design, 5 participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po; after a minimum of 14 days, participants received warfarin alone 7.5mg po.
518656|NCT00777855|P1|Participant Flow|Warfarin First, Then Warfarin+Rifampin|In a randomized, single-dose, two-period, crossover design, 5 participants received warfarin alone 7.5mg po; after a minimum of 14 days, participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po.
518657|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
518658|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
518659|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
518660|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
518661|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
518662|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
518663|NCT00777855|E1|Reported Event|Entire Study Population|Each of 10 participants received both study treatments, in randomly assigned sequence, separated by a minimum of 14 days
518664|NCT00777946|B4|Baseline|Total|Total of all reporting groups
518665|NCT00777946|B3|Baseline|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
518666|NCT00777946|B2|Baseline|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518667|NCT00777946|B1|Baseline|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518668|NCT00777946|P3|Participant Flow|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
518669|NCT00777946|P2|Participant Flow|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518670|NCT00777946|P1|Participant Flow|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518671|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
518672|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518673|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518674|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
518675|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518676|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518677|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
518678|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518679|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518680|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
518681|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518682|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518683|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
518684|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518685|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518686|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
518687|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518688|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518689|NCT00777946|E3|Reported Event|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
518690|NCT00777946|E2|Reported Event|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518731|NCT00778167|P3|Participant Flow|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
518691|NCT00777946|E1|Reported Event|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
518693|NCT00778102|B2|Baseline|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518694|NCT00778102|B1|Baseline|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518695|NCT00778102|P2|Participant Flow|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus oxaliplatin, irinotecan, leucovorin, and 5-FU (FOLFOXIRI). Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518696|NCT00778102|P1|Participant Flow|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX-6). Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 milligrams per kilogram (mg/kg) via intravenous (IV) infusion; oxaliplatin 85 milligrams per meter-squared (mg/m^2) via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, progressive disease (PD), unacceptable toxicity, or participant refusal.
518697|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518698|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518699|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518700|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518701|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518702|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518703|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518732|NCT00778167|P2|Participant Flow|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
518735|NCT00778167|O2|Outcome|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
518831|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
518704|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518705|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518706|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518707|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518708|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518709|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518710|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518711|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518712|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518713|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518714|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518715|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
519519|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
518716|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518717|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518718|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518719|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518720|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518721|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518722|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518723|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518724|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518725|NCT00778102|E2|Reported Event|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518726|NCT00778102|E1|Reported Event|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
518727|NCT00778167|B4|Baseline|Total|Total of all reporting groups
518728|NCT00778167|B3|Baseline|Cohort 3|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
518729|NCT00778167|B2|Baseline|Cohort 2|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
518730|NCT00778167|B1|Baseline|Cohort 1|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
526864|NCT00792116|O2|Outcome|Non-Gum Chewing|
518736|NCT00778167|O1|Outcome|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
518737|NCT00778167|E3|Reported Event|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
518738|NCT00778167|E2|Reported Event|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
518739|NCT00778167|E1|Reported Event|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
518740|NCT00778258|B10|Baseline|Total|Total of all reporting groups
518741|NCT00778258|B9|Baseline|Non-Randomized – Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
518742|NCT00778258|B8|Baseline|Non-Randomized – Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
518743|NCT00778258|B7|Baseline|Not Randomized – Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
518744|NCT00778258|B6|Baseline|Maintenance- Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518745|NCT00778258|B5|Baseline|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518746|NCT00778258|B4|Baseline|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518747|NCT00778258|B3|Baseline|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518748|NCT00778258|B2|Baseline|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518749|NCT00778258|B1|Baseline|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518768|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
518769|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
518770|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
518771|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
518750|NCT00778258|P9|Participant Flow|Non-Randomized – Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
518751|NCT00778258|P8|Participant Flow|Non-Randomized – Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
518752|NCT00778258|P7|Participant Flow|Not Randomized – Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
518753|NCT00778258|P6|Participant Flow|Maintenance- Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518754|NCT00778258|P5|Participant Flow|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518755|NCT00778258|P4|Participant Flow|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518756|NCT00778258|P3|Participant Flow|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518757|NCT00778258|P2|Participant Flow|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518758|NCT00778258|P1|Participant Flow|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518759|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
518760|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
518761|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
518762|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
518763|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
518764|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
518765|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
518766|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
518767|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
526865|NCT00792116|O1|Outcome|Gum Chewing|
518772|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
518773|NCT00778258|O3|Outcome|Group 4 - Milk|Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
518774|NCT00778258|O2|Outcome|Group 3 – Rice Pudding|Participants in this group experienced a reaction to rice pudding during their baseline visit oral food challenge
518775|NCT00778258|O1|Outcome|Group 2 – Pizza|Participants in this group experienced a reaction to pizza during their baseline visit oral food challenge
518776|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
518777|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
518778|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
518779|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
518780|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
518781|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
518782|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
518783|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
518784|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
518785|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
518786|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
518787|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
518788|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
518789|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
518790|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
518791|NCT00778258|O3|Outcome|Group 4 - Milk|Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
518792|NCT00778258|O2|Outcome|Group 3 – Rice Pudding|Participants in this group experienced a reaction to rice pudding during their baseline visit oral food challenge
518793|NCT00778258|O1|Outcome|Group 2 – Pizza|Participants in this group experienced a reaction to pizza during their baseline visit oral food challenge
518794|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.[Maintenance arm].
518795|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.[Dose Escalation arm].
518796|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.[Maintenance arm].
518797|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.[Dose Escalation arm].
518798|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
518799|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
518800|NCT00778258|E9|Reported Event|Non-Randomized - Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
518801|NCT00778258|E8|Reported Event|Non-Randomized - Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
518802|NCT00778258|E7|Reported Event|Not Randomized - Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
518828|NCT00778336|P1|Participant Flow|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
519699|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
518829|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
518830|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
518803|NCT00778258|E6|Reported Event|Maintenance - Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518804|NCT00778258|E5|Reported Event|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518805|NCT00778258|E4|Reported Event|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518806|NCT00778258|E3|Reported Event|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518807|NCT00778258|E2|Reported Event|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518808|NCT00778258|E1|Reported Event|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
518809|NCT00778310|B3|Baseline|Total|Total of all reporting groups
518810|NCT00778310|B2|Baseline|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
518811|NCT00778310|B1|Baseline|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
518812|NCT00778310|P2|Participant Flow|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
518813|NCT00778310|P1|Participant Flow|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
518814|NCT00778310|O4|Outcome|Children Placebo Condition|This is the BOLD signal data on the Placebo day scan.
518815|NCT00778310|O3|Outcome|Children Drug Condition|This is the BOLD signal data on the Concerta day scan.
518816|NCT00778310|O2|Outcome|Adults Placebo Condition|This is the BOLD signal data on the Placebo day scan.
518817|NCT00778310|O1|Outcome|Adults Drug Condition|This is the BOLD signal data on the Concerta day scan.
518818|NCT00778310|E2|Reported Event|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
518819|NCT00778310|E1|Reported Event|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
518820|NCT00778336|B5|Baseline|Total|Total of all reporting groups
518821|NCT00778336|B4|Baseline|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
518822|NCT00778336|B3|Baseline|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
518823|NCT00778336|B2|Baseline|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
518824|NCT00778336|B1|Baseline|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
518825|NCT00778336|P4|Participant Flow|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
518826|NCT00778336|P3|Participant Flow|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
518827|NCT00778336|P2|Participant Flow|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
518832|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
518833|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
518834|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
518835|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
518836|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
518837|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
518838|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
518839|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
518840|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
518841|NCT00778336|E4|Reported Event|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
518842|NCT00778336|E3|Reported Event|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
518843|NCT00778336|E2|Reported Event|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
518844|NCT00778336|E1|Reported Event|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
518845|NCT00778375|B1|Baseline|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
518846|NCT00778375|P1|Participant Flow|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 by vein (IV) as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
518847|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
518848|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
518849|NCT00778375|O2|Outcome|Re-Induction|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
518850|NCT00778375|O1|Outcome|Induction Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
518851|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
518852|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
518853|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
518854|NCT00778375|E1|Reported Event|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
518855|NCT00772889|B4|Baseline|Total|Total of all reporting groups
518856|NCT00772889|B3|Baseline|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518857|NCT00772889|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518858|NCT00772889|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518859|NCT00772889|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518860|NCT00772889|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518861|NCT00772889|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518862|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518863|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518864|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518865|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518866|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518867|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518868|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518869|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518870|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518871|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518872|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518873|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518874|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518875|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518876|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518877|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518878|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518879|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518880|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518881|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518882|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518883|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518884|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518885|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518886|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518887|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518888|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518889|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518890|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518891|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518892|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518893|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518894|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518895|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518896|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518897|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518898|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518899|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518900|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518901|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518902|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518903|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518904|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518905|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518906|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518907|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518908|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518909|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518910|NCT00772889|E3|Reported Event|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
518911|NCT00772889|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
518912|NCT00772889|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
518995|NCT00778648|E2|Reported Event|Placebo|
518996|NCT00778648|E1|Reported Event|Juice Plus|
526866|NCT00792116|O2|Outcome|Non-Gum Chewing|
518913|NCT00772915|B1|Baseline|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. >
> Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
518940|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518914|NCT00772915|P1|Participant Flow|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. >
> Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
518915|NCT00772915|O1|Outcome|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.
Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
518916|NCT00772915|E1|Reported Event|Lenalidomide With On-Demand Dexamethasone|Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.
518917|NCT00772928|B3|Baseline|Total|Total of all reporting groups
518918|NCT00772928|B2|Baseline|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
518919|NCT00772928|B1|Baseline|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
518920|NCT00772928|P2|Participant Flow|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
518921|NCT00772928|P1|Participant Flow|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
518922|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
518923|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
518924|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
518925|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
518926|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
518927|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
518928|NCT00772928|E2|Reported Event|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
518929|NCT00772928|E1|Reported Event|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
518930|NCT00778622|B4|Baseline|Total|Total of all reporting groups
518931|NCT00778622|B3|Baseline|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
518932|NCT00778622|B2|Baseline|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
518933|NCT00778622|B1|Baseline|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
518934|NCT00778622|P3|Participant Flow|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to (>=) 28 kg/m^2. Initial dose of Glucophage extended release (XR)on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
518935|NCT00778622|P2|Participant Flow|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to (>=) 24 kg/m^2 and less than (<) 28 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
518936|NCT00778622|P1|Participant Flow|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to (>=)18.5 kilogram per meter squared (kg/m^2) and less than (<) 24 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks.
518937|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
518938|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
519520|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
518939|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
518941|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518942|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518943|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518944|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518945|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518946|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518947|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518948|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518949|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518950|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518951|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518952|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518953|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518954|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518955|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518956|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518957|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518958|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518959|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518960|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518961|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518962|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518963|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518964|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518965|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518966|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518967|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518968|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518969|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518970|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518971|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518972|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518973|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518974|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518975|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518976|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518977|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518978|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518979|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518980|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518981|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518982|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518983|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518984|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 .
518985|NCT00778622|E3|Reported Event|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
518986|NCT00778622|E2|Reported Event|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
518987|NCT00778622|E1|Reported Event|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
518988|NCT00778648|B3|Baseline|Total|Total of all reporting groups
518989|NCT00778648|B2|Baseline|Placebo|
518990|NCT00778648|B1|Baseline|Juice Plus|
518991|NCT00778648|P2|Participant Flow|Placebo|
518992|NCT00778648|P1|Participant Flow|Juice Plus|
518993|NCT00778648|O2|Outcome|Placebo|
518994|NCT00778648|O1|Outcome|Juice Plus|
518997|NCT00778817|B1|Baseline|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519455|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
518998|NCT00778817|P1|Participant Flow|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
518999|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519000|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519001|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519002|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519003|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519004|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519005|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519006|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519007|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519008|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519009|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519010|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519011|NCT00778817|E1|Reported Event|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
519012|NCT00778830|B3|Baseline|Total|Total of all reporting groups
519013|NCT00778830|B2|Baseline|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519014|NCT00778830|B1|Baseline|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519015|NCT00778830|P2|Participant Flow|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519016|NCT00778830|P1|Participant Flow|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519017|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519213|NCT00780741|E1|Reported Event|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519214|NCT00780910|B1|Baseline|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519018|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519019|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519020|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519021|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519022|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519023|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519024|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
519025|NCT00778830|E2|Reported Event|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Oxaliplatin was administered intravenously at a dose of 100 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
519026|NCT00778830|E1|Reported Event|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Irinotecan was administered intravenously at a dose of 180 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
519027|NCT00778869|B1|Baseline|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
519028|NCT00778869|P1|Participant Flow|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
519029|NCT00778869|O1|Outcome|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54 in participants with AS.
519030|NCT00778869|E1|Reported Event|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
519031|NCT00778895|B4|Baseline|Total|Total of all reporting groups
519032|NCT00778895|B3|Baseline|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519033|NCT00778895|B2|Baseline|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519034|NCT00778895|B1|Baseline|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519452|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519035|NCT00778895|P3|Participant Flow|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519036|NCT00778895|P2|Participant Flow|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519037|NCT00778895|P1|Participant Flow|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519038|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519039|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519040|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519041|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519042|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519043|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519044|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519045|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519046|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519047|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519048|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519049|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519050|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519051|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519052|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519071|NCT00778895|E3|Reported Event|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519053|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519054|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519055|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519056|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519057|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519058|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519059|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519060|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519061|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519062|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519063|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519064|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519065|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519066|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519067|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519068|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519069|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519070|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
526867|NCT00792116|O1|Outcome|Gum Chewing|
519072|NCT00778895|E2|Reported Event|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519073|NCT00778895|E1|Reported Event|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
519074|NCT00778921|B4|Baseline|Total|Total of all reporting groups
519075|NCT00778921|B3|Baseline|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
519076|NCT00778921|B2|Baseline|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
519077|NCT00778921|B1|Baseline|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
519078|NCT00778921|P3|Participant Flow|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
519079|NCT00778921|P2|Participant Flow|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
519080|NCT00778921|P1|Participant Flow|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
519081|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
519082|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
519083|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
519084|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
519085|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
519086|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
519087|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
519088|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
519089|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
519090|NCT00778921|E3|Reported Event|Amlodipine 10mg|Amlodipine 10mg
519091|NCT00778921|E2|Reported Event|Aliskiren 150mg/ Amlodipine 10mg|Aliskiren 150mg/ Amlodipine 10mg
519092|NCT00778921|E1|Reported Event|Aliskiren 300mg/ Amlodipine 10mg|Aliskiren 300mg/ Amlodipine 10mg
519093|NCT00780338|B3|Baseline|Total|Total of all reporting groups
519094|NCT00780338|B2|Baseline|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519095|NCT00780338|B1|Baseline|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519096|NCT00780338|P2|Participant Flow|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519097|NCT00780338|P1|Participant Flow|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519098|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519118|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519144|NCT00780455|P2|Participant Flow|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519453|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519099|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519100|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
519101|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
519102|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519103|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519104|NCT00780338|O2|Outcome|AGTO Group - Non AGTO Users|Those assigned to AGTO intervention, but did NOT participate in the AGTO intervention.
519105|NCT00780338|O1|Outcome|AGTO Group - AGTO Users|Those assigned to AGTO intervention, but did participate in the AGTO intervention.
519106|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519107|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519108|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519109|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519110|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
519111|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
519112|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
519113|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
519114|NCT00780338|O2|Outcome|AGTO Group - Non AGTO Users|Those assigned to AGTO intervention, but did NOT participate in the AGTO intervention.
519115|NCT00780338|O1|Outcome|AGTO Group - AGTO Users|Those assigned to AGTO intervention, but did participate in the AGTO intervention.
519116|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519117|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519119|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519120|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519121|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.
Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519122|NCT00780338|E2|Reported Event|Control|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Assets Getting To Outcomes: Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519123|NCT00780338|E1|Reported Event|AGTO|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.
Assets Getting To Outcomes: Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
519124|NCT00780403|B1|Baseline|Total Population|All randomized subjects.
519125|NCT00780403|P2|Participant Flow|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).
519126|NCT00780403|P1|Participant Flow|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
519127|NCT00780403|O3|Outcome|No Preference|All randomized subjects.
519128|NCT00780403|O2|Outcome|Zyrtec|All randomized subjects.
519129|NCT00780403|O1|Outcome|RediTab|All randomized subjects.
519130|NCT00780403|E2|Reported Event|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).
519131|NCT00780403|E1|Reported Event|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
519132|NCT00780416|B3|Baseline|Total|Total of all reporting groups
519133|NCT00780416|B2|Baseline|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
519134|NCT00780416|B1|Baseline|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519135|NCT00780416|P2|Participant Flow|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
519136|NCT00780416|P1|Participant Flow|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519137|NCT00780416|O2|Outcome|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
519138|NCT00780416|O1|Outcome|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519139|NCT00780416|E2|Reported Event|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
519140|NCT00780416|E1|Reported Event|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519141|NCT00780455|B3|Baseline|Total|Total of all reporting groups
519142|NCT00780455|B2|Baseline|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519143|NCT00780455|B1|Baseline|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519145|NCT00780455|P1|Participant Flow|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519146|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519147|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519148|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519149|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519150|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519151|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519152|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519153|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519154|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519155|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519156|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519157|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519158|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519159|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519160|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519161|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519162|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519163|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519164|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519165|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519166|NCT00780455|E2|Reported Event|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519167|NCT00780455|E1|Reported Event|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
519168|NCT00780481|B1|Baseline|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.
Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
519169|NCT00780481|P1|Participant Flow|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.
Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
519170|NCT00780481|O1|Outcome|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.
Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
519171|NCT00780481|O1|Outcome|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.
Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
519172|NCT00780481|O1|Outcome|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.
Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
519173|NCT00780481|O1|Outcome|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.
Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
519174|NCT00780481|E1|Reported Event|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.
Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
519175|NCT00780572|B3|Baseline|Total|Total of all reporting groups
519176|NCT00780572|B2|Baseline|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
519177|NCT00780572|B1|Baseline|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group
ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
519178|NCT00780572|P2|Participant Flow|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
519179|NCT00780572|P1|Participant Flow|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group
ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
519180|NCT00780572|O2|Outcome|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
519181|NCT00780572|O1|Outcome|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group
ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
519182|NCT00780572|E2|Reported Event|Arm 2: Control/No Alert|The second arm is the control. Alerts will not be displayed for these patients.
519212|NCT00780741|E2|Reported Event|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519183|NCT00780572|E1|Reported Event|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group
ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
519184|NCT00780676|B6|Baseline|Total|Total of all reporting groups
519185|NCT00780676|B5|Baseline|MEK Pathway Predictor Negative|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
519186|NCT00780676|B4|Baseline|MEK Pathway Activity Predictor Positive|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (either MEK pathway activity predictor positive or MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
519187|NCT00780676|B3|Baseline|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
519188|NCT00780676|B2|Baseline|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
519189|NCT00780676|B1|Baseline|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
519190|NCT00780676|P5|Participant Flow|MEK Pathway Predictor Negative|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
519191|NCT00780676|P4|Participant Flow|MEK Pathway Activity Predictor Positive|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway activity predictor positive) receive selumetinib 75 mg by mouth twice daily (BID).
519192|NCT00780676|P3|Participant Flow|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
519193|NCT00780676|P2|Participant Flow|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
519194|NCT00780676|P1|Participant Flow|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
519195|NCT00780676|O3|Outcome|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
519196|NCT00780676|O2|Outcome|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
519197|NCT00780676|O1|Outcome|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
519198|NCT00780676|E1|Reported Event|Dasatinib 100 mg|Participants with one of 3 predictive gene signatures (dasatinib sensitivity signature, SRC pathway activity signature and dasatinib target index) received Dasatinib 100 mg orally daily.
519199|NCT00780741|B3|Baseline|Total|Total of all reporting groups
519200|NCT00780741|B2|Baseline|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519201|NCT00780741|B1|Baseline|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519202|NCT00780741|P2|Participant Flow|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a surgical facility under general anesthesia within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519203|NCT00780741|P1|Participant Flow|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office setting using topical anesthesia and infant restraint. Probing to be performed either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519204|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519205|NCT00780741|O1|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist.
519206|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519207|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519208|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519209|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519210|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519211|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
519514|NCT00782210|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519215|NCT00780910|P1|Participant Flow|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519216|NCT00780910|O1|Outcome|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519217|NCT00780910|E1|Reported Event|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519218|NCT00781079|B3|Baseline|Total|Total of all reporting groups
519219|NCT00781079|B2|Baseline|Arm 2|Care as usual
519220|NCT00781079|B1|Baseline|Arm 1|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
519221|NCT00781079|P2|Participant Flow|Arm 2|Care as usual
519222|NCT00781079|P1|Participant Flow|Arm 1|"Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA): Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)"
519223|NCT00781079|O2|Outcome|Care as Usual|Care as usual on the case management teams
519224|NCT00781079|O1|Outcome|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
519225|NCT00781079|O2|Outcome|Care as Usual|Care as usual on the case management teams
519226|NCT00781079|O1|Outcome|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
519227|NCT00781079|E2|Reported Event|Case as Usual|Care as usual on case management teams
519228|NCT00781079|E1|Reported Event|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
519229|NCT00781274|B1|Baseline|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519230|NCT00781274|P1|Participant Flow|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519231|NCT00781274|O1|Outcome|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519232|NCT00781274|E1|Reported Event|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
519233|NCT00781326|B1|Baseline|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
519234|NCT00781326|P1|Participant Flow|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
519235|NCT00781326|O1|Outcome|Open Label Antidepressant|"In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
Nimodipine: Nimodipine will be initiated at one, 30-mg tablet three times a day for 1 week, increased to 2 tablets three times a day for 1 week, and then increased to three tablets three times a day for the remaining 30 weeks of the study. Participants who cannot tolerate the maximum dose of 270 mg/day will be maintained at the highest tolerable dose.
Placebo: Placebo will be given in doses matching those of nimodipine."
519236|NCT00781326|E1|Reported Event|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
519237|NCT00781365|B3|Baseline|Total|Total of all reporting groups
519238|NCT00781365|B2|Baseline|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
519239|NCT00781365|B1|Baseline|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
519240|NCT00781365|P2|Participant Flow|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
519241|NCT00781365|P1|Participant Flow|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
519242|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
519243|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
519454|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519244|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
519245|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
519246|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
519247|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
519248|NCT00781365|E2|Reported Event|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
519249|NCT00781365|E1|Reported Event|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
519250|NCT00781391|B4|Baseline|Total|Total of all reporting groups
519251|NCT00781391|B3|Baseline|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519252|NCT00781391|B2|Baseline|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519253|NCT00781391|B1|Baseline|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519254|NCT00781391|P3|Participant Flow|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519255|NCT00781391|P2|Participant Flow|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519256|NCT00781391|P1|Participant Flow|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519257|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519258|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519259|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519260|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519261|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519262|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519263|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519264|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519265|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519266|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519267|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519268|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519269|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519270|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519271|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519272|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519273|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519274|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519275|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519276|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519277|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519278|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519279|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519280|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519281|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519282|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519283|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519284|NCT00781391|E3|Reported Event|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519285|NCT00781391|E2|Reported Event|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets
Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin: placebo warfarin"
519286|NCT00781391|E1|Reported Event|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets
warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
placebo edoxaban: placebo edoxaban"
519287|NCT00781456|B3|Baseline|Total|Total of all reporting groups
519288|NCT00781456|B2|Baseline|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
519289|NCT00781456|B1|Baseline|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
519290|NCT00781456|P2|Participant Flow|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
519291|NCT00781456|P1|Participant Flow|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
519292|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
519293|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
519294|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
519295|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
519296|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
519515|NCT00782210|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519297|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
519298|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
519299|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
519300|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
519301|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
519302|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
519303|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
519304|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
519305|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
519306|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
519307|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
519308|NCT00781456|E2|Reported Event|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
519309|NCT00781456|E1|Reported Event|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
519310|NCT00781508|B3|Baseline|Total|Total of all reporting groups
519311|NCT00781508|B2|Baseline|Placebo First Sildenafil Second|Effect of placebo on left ventricular filling pressures in patients with heart failure
519312|NCT00781508|B1|Baseline|Sildenafil First Placebo Second|Effect of sildenafil on left ventricular filling pressures in patients with heart failure
519313|NCT00781508|P2|Participant Flow|Placebo Then Sildenafil|Effect of Sildenafil on left ventricular function
519314|NCT00781508|P1|Participant Flow|Sildenafil Then Placebo|Effect of sildenafil on left ventricular filling pressures in patients with heart failure
519315|NCT00781508|O2|Outcome|Placebo First Then Sildenafil|placebo orally, then sildenafil 50 mg orally 2 days later.
519316|NCT00781508|O1|Outcome|Sildenafil First Then Placebo|Sildenafil 50 mg orally, placebo orally 2 days later.
519317|NCT00781508|O2|Outcome|Placebo First Then Sildenafil|placebo administered orally, then sildenafil orally 48 hrs later
519318|NCT00781508|O1|Outcome|Sildenafil First Then Placebo|sildenafil 50 mg administered orally, placebo administered orally 48 hrs later
519319|NCT00781508|E2|Reported Event|Placebo First Then Sildenafil|Effect of placebo on left ventricular filing pressures, then effect of sildenafil on left ventricular filling pressure.
519320|NCT00781508|E1|Reported Event|Sildenafil First Then Placebo|Effect of sildenafil first on left ventricular filling pressures, then effect of placebo on left ventricular filling pressure
519321|NCT00781599|B3|Baseline|Total|Total of all reporting groups
519322|NCT00781599|B2|Baseline|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
519323|NCT00781599|B1|Baseline|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
519324|NCT00781599|P2|Participant Flow|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
519325|NCT00781599|P1|Participant Flow|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
519326|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
519327|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
519516|NCT00782210|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519328|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
519329|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
519330|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
519331|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
519332|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
519333|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
519334|NCT00781599|E2|Reported Event|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
519335|NCT00781599|E1|Reported Event|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
519336|NCT00781859|B3|Baseline|Total|Total of all reporting groups
519337|NCT00781859|B2|Baseline|Placebo|Intravitreal injection of placebo
519338|NCT00781859|B1|Baseline|Ocriplasmin 125µg|125µg microplasmin intravitreal injection
519339|NCT00781859|P2|Participant Flow|Placebo|Intravitreal injection of placebo
519340|NCT00781859|P1|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
519341|NCT00781859|O2|Outcome|Placebo|Intravitreal injection of placebo
519342|NCT00781859|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
519343|NCT00781859|O2|Outcome|Placebo|Intravitreal injection of placebo
519344|NCT00781859|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
519345|NCT00781859|E2|Reported Event|Placebo|Intravitreal injection of placebo
519346|NCT00781859|E1|Reported Event|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
519347|NCT00781937|B3|Baseline|Total|Total of all reporting groups
519348|NCT00781937|B2|Baseline|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519349|NCT00781937|B1|Baseline|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519350|NCT00781937|P2|Participant Flow|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519351|NCT00781937|P1|Participant Flow|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519352|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519353|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519414|NCT00781950|O1|Outcome|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat and wheat bran to replace the flaxseed daily for one year.
526868|NCT00792116|O2|Outcome|Non-Gum Chewing|
519354|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519355|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519356|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519357|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519358|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519359|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519360|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519361|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519362|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519363|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519364|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519365|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519366|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519367|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519415|NCT00781950|E2|Reported Event|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year
Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
526869|NCT00792116|O1|Outcome|Gum Chewing|
519368|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519369|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519370|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519371|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519372|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519373|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519374|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519375|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519376|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519377|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519378|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519379|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519380|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519381|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519416|NCT00781950|E1|Reported Event|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
519417|NCT00781963|B4|Baseline|Total|Total of all reporting groups
519382|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519383|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519384|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519385|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519386|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519387|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519388|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519389|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519390|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519391|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519392|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519393|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519394|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519395|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519418|NCT00781963|B3|Baseline|Control|"Group-based Behavioral Sleep Intervention II
Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
519517|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519396|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519397|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519398|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519399|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519400|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519401|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519402|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519403|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519404|NCT00781937|E2|Reported Event|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
519405|NCT00781937|E1|Reported Event|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
519406|NCT00781950|B3|Baseline|Total|Total of all reporting groups
519407|NCT00781950|B2|Baseline|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year
Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
519408|NCT00781950|B1|Baseline|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
519409|NCT00781950|P2|Participant Flow|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year
Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
519410|NCT00781950|P1|Participant Flow|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
519411|NCT00781950|O2|Outcome|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year
Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
519412|NCT00781950|O1|Outcome|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
519413|NCT00781950|O2|Outcome|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year
Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
519518|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519419|NCT00781963|B2|Baseline|Group CBTI|"Group-based Behavioral Sleep Intervention I
Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
519420|NCT00781963|B1|Baseline|Individual CBTI|"Individual-Behavioral Sleep Intervention
Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
519421|NCT00781963|P3|Participant Flow|Arm 3|"Group-based Behavioral Sleep Intervention II
Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
519422|NCT00781963|P2|Participant Flow|Arm 2|"Group-based Behavioral Sleep Intervention I
Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
519423|NCT00781963|P1|Participant Flow|Arm 1|"Individual-Behavioral Sleep Intervention
Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
519424|NCT00781963|O3|Outcome|Arm 3|"Group-based Behavioral Sleep Intervention II
Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
519425|NCT00781963|O2|Outcome|Arm 2|"Group-based Behavioral Sleep Intervention I
Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
519426|NCT00781963|O1|Outcome|Arm 1|"Individual-Behavioral Sleep Intervention
Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
519427|NCT00781963|E3|Reported Event|Arm 3|"Group-based Behavioral Sleep Intervention II
Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
519428|NCT00781963|E2|Reported Event|Arm 2|"Group-based Behavioral Sleep Intervention I
Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
519429|NCT00781963|E1|Reported Event|Arm 1|"Individual-Behavioral Sleep Intervention
Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
519430|NCT00782067|B1|Baseline|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
519431|NCT00782067|P1|Participant Flow|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
519432|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
519433|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
519434|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
519435|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
519436|NCT00782067|E1|Reported Event|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
519437|NCT00782171|B3|Baseline|Total|Total of all reporting groups
519438|NCT00782171|B2|Baseline|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519439|NCT00782171|B1|Baseline|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519440|NCT00782171|P2|Participant Flow|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519441|NCT00782171|P1|Participant Flow|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519442|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519443|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519444|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519445|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519446|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519447|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519448|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519449|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519450|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519451|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519456|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519457|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519458|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519459|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519460|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519461|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519462|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519463|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519464|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519465|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519466|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519467|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519468|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
SLActive dental implant"
519469|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery
SLActive dental implant"
519470|NCT00782171|E2|Reported Event|Early Loading|Healing caps will be placed on the SLActive Implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
519471|NCT00782171|E1|Reported Event|Immediate Loading|SLActive Implant(s) will be restored with a temporary restoration on the day of surgery.
519472|NCT00782184|B3|Baseline|Total|Total of all reporting groups
519473|NCT00782184|B2|Baseline|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519474|NCT00782184|B1|Baseline|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519475|NCT00782184|P2|Participant Flow|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519476|NCT00782184|P1|Participant Flow|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519477|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519478|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519479|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519480|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519481|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519482|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519483|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519484|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519485|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519486|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519523|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519487|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519488|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519489|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519490|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519491|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519492|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519493|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519494|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519495|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519496|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519497|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519498|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519499|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519500|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519501|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519502|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519503|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519504|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519505|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519506|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519507|NCT00782184|E3|Reported Event|Placebo|One participant received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, the participant was randomized to the ezetimbe/simvastatin group, but took only pills from the bottle containing placebo to atorvastatin during the 6-week double-blind treatment period.
519508|NCT00782184|E2|Reported Event|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
519509|NCT00782184|E1|Reported Event|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
519510|NCT00782210|B4|Baseline|Total|Total of all reporting groups
519511|NCT00782210|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519512|NCT00782210|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519513|NCT00782210|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519521|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519522|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519524|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519525|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519526|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519527|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519528|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519529|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519530|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519531|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519532|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519533|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519534|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519535|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519536|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
519537|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
519538|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519539|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519540|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519541|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519542|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
519543|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
519544|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519545|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519546|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519547|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519548|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
519549|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
519550|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519551|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519552|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519553|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519554|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519555|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519556|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519557|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519558|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519559|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519560|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519561|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519562|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519563|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519564|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519565|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519566|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519567|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519568|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519569|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519570|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519571|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519572|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519573|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519574|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519575|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519576|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519577|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519578|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519579|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519580|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519581|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519582|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519583|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519584|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519585|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519586|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519587|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519588|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519589|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519590|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519591|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519592|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519593|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519594|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519595|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519596|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519597|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519598|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519599|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519600|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519601|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519602|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519603|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519604|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519605|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519606|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519607|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519608|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519609|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519610|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519611|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519612|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519613|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519614|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519615|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519616|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519617|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519618|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519619|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519620|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519621|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519622|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519623|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519624|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519625|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519626|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519627|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519628|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519629|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519630|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519631|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519632|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519633|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519634|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519635|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519636|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519637|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
526870|NCT00792259|B4|Baseline|Total|Total of all reporting groups
519638|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519639|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519640|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519641|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519642|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519643|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519644|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519645|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519646|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519647|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519648|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519649|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519650|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519651|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519652|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519653|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519654|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519655|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519656|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519657|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519658|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519659|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519660|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519661|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519662|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519663|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519664|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519665|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519666|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519667|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519668|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519669|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519670|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519671|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519672|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519673|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519674|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519675|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519676|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519677|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519678|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519679|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519680|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519681|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519682|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519683|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519684|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519685|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519686|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519687|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519688|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519689|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519690|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519691|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519692|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519693|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519694|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519695|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519696|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519697|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519698|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528271|NCT00802672|B3|Baseline|Vehicle Product|placebo
519700|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519701|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519702|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519703|NCT00782210|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519704|NCT00782210|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519705|NCT00782210|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519706|NCT00782288|B4|Baseline|Total|Total of all reporting groups
519707|NCT00782288|B3|Baseline|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519708|NCT00782288|B2|Baseline|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519709|NCT00782288|B1|Baseline|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519710|NCT00782288|P3|Participant Flow|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519711|NCT00782288|P2|Participant Flow|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519712|NCT00782288|P1|Participant Flow|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519713|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519714|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519715|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519716|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519717|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519718|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519719|NCT00782288|O1|Outcome|All Participants|All study participants had nasal cells collected pre and post treatment during the study. Because the data set is extremely large, the full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO) this information can be obtained under the accession number.
519720|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519721|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519722|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519723|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519724|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519725|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519726|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519727|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519728|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519729|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519730|NCT00782288|O2|Outcome|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519731|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519732|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519733|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519734|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519735|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519736|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519737|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519738|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519739|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519740|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519741|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519742|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519743|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519744|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519745|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519746|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519747|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519748|NCT00782288|O2|Outcome|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519749|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519750|NCT00782288|E3|Reported Event|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days
digitoxin: 0.1mg pills, once daily for 28 days."
519751|NCT00782288|E2|Reported Event|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days
digitoxin: 0.05mg tabs, once daily for 28 days"
519752|NCT00782288|E1|Reported Event|Placebo|"placebo given daily for 28 days
placebo: pill taken once daily for 28 days"
519753|NCT00782340|B4|Baseline|Total|Total of all reporting groups
519754|NCT00782340|B3|Baseline|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519755|NCT00782340|B2|Baseline|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519756|NCT00782340|B1|Baseline|Not Randomized|Patients entered open label droxidopa dose titration, but did not proceed into washout and randomization.
519757|NCT00782340|P3|Participant Flow|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519758|NCT00782340|P2|Participant Flow|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519759|NCT00782340|P1|Participant Flow|Open-Label Titration|All patients titrated to their optimal dose of droxidopa for up to 2 weeks during open-label dose titration.
519760|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519761|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519762|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519763|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519764|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519765|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519766|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519767|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519768|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519792|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519793|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519794|NCT00782379|E1|Reported Event|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519795|NCT00782418|B1|Baseline|All Patients|All patients from all arms
519769|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519770|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519771|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519772|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519773|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519774|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519775|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519776|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519777|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519778|NCT00782340|E3|Reported Event|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519779|NCT00782340|E2|Reported Event|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
519780|NCT00782340|E1|Reported Event|Open-Label Titration|All patients treated with study drug during dose titration (7-14 days)
519781|NCT00782379|B1|Baseline|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519782|NCT00782379|P1|Participant Flow|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519783|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519784|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519785|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519786|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519787|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519788|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519789|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519790|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
519791|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
528272|NCT00802672|B2|Baseline|Reference Product|Loprox Cream
519796|NCT00782418|P7|Participant Flow|Placebo (HGC or GGI)|Hyperglycemic Clamp or Graded Glucose Infusion: Treatment Group Placebo
519797|NCT00782418|P6|Participant Flow|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
519798|NCT00782418|P5|Participant Flow|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
519799|NCT00782418|P4|Participant Flow|Exenatide 5 ug Down Dosed to Placebo (HGC)|Hyperglycemic Clamp: Treatment Group Exenatide 5 ug down dosed to placebo
519800|NCT00782418|P3|Participant Flow|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
519801|NCT00782418|P2|Participant Flow|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
519802|NCT00782418|P1|Participant Flow|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
519803|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
519804|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
519805|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
519806|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
519807|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
519808|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
519809|NCT00782418|O6|Outcome|GGI - Placebo|Graded Glucose Infusion: Treatment Group Placebo
519810|NCT00782418|O5|Outcome|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
519811|NCT00782418|O4|Outcome|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
519812|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
519813|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
519814|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
519815|NCT00782418|E6|Reported Event|GGI - Placebo|Graded Glucose Infusion: Treatment Group Placebo
519816|NCT00782418|E5|Reported Event|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
519817|NCT00782418|E4|Reported Event|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
519818|NCT00782418|E3|Reported Event|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
519819|NCT00782418|E2|Reported Event|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
519820|NCT00782418|E1|Reported Event|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
519821|NCT00782483|B1|Baseline|Overall|Overall Study Group
519822|NCT00782483|P1|Participant Flow|Laser Therapy|Total number of participants
519823|NCT00782483|O1|Outcome|Laser Therapy|Total number of participants
519824|NCT00782483|E1|Reported Event|Overall|Overall Study Group
519825|NCT00782496|B3|Baseline|Total|Total of all reporting groups
519826|NCT00782496|B2|Baseline|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
519827|NCT00782496|B1|Baseline|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
519828|NCT00782496|P2|Participant Flow|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
519829|NCT00782496|P1|Participant Flow|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
519830|NCT00782496|O1|Outcome|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
519831|NCT00782496|O2|Outcome|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
519832|NCT00782496|O1|Outcome|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
519833|NCT00782496|E2|Reported Event|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
519834|NCT00782496|E1|Reported Event|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
519835|NCT00782509|B4|Baseline|Total|Total of all reporting groups
519836|NCT00782509|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519837|NCT00782509|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519838|NCT00782509|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519839|NCT00782509|P3|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519840|NCT00782509|P2|Participant Flow|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519841|NCT00782509|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519842|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519843|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519844|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519845|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519846|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519847|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519848|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519849|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519850|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519851|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519852|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519853|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519854|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519855|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519856|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519857|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519858|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519859|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519860|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519861|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
519862|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
519863|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519864|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519865|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519866|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519867|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
519868|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
519869|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519870|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519871|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
519872|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
519873|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
519874|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
519875|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519876|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519877|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519878|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519879|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519880|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519881|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519882|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519883|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519884|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519885|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519886|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519887|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519888|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519889|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519890|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519891|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519892|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519893|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519894|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519895|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519896|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519897|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519898|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519899|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519900|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519901|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519902|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519903|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519904|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519905|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519906|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519907|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519908|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519909|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519910|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519911|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519912|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519913|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519914|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519915|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519916|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519917|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519918|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519919|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519920|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519921|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519922|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519923|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519924|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519925|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519926|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519927|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519928|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519929|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519930|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519931|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519932|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519933|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519934|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519935|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519936|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519937|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519938|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519939|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519940|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519941|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519942|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519943|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519944|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519945|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519946|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519947|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519948|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519949|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519950|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519951|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519952|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519953|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519954|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519955|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519956|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519957|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519958|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519959|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519960|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519961|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519962|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519963|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519964|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519965|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519966|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519967|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519968|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519969|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528273|NCT00802672|B1|Baseline|Test Product|Ciclopirox cream
519970|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519971|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519972|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519973|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519974|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519975|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519976|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519977|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519978|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519979|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519980|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
519981|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519982|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519983|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519984|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519985|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519986|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519987|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519988|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519989|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519990|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519991|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519992|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519993|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519994|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519995|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519996|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
519997|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
519998|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
519999|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
520000|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
520001|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
520002|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
520003|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
520004|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
520005|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
520006|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
520007|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
520008|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
520009|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
520010|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
520011|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
520012|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
520013|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
520014|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
520015|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
520016|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
520017|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
520018|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
520019|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
520020|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
520021|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
520022|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
520023|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
520024|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
520025|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
520026|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
520027|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
520028|NCT00782509|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
520029|NCT00782509|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
520030|NCT00782509|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528274|NCT00802672|P3|Participant Flow|Vehicle Product|placebo
520076|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
520434|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520031|NCT00782626|B1|Baseline|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
520032|NCT00782626|P1|Participant Flow|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
520033|NCT00782626|O1|Outcome|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
520034|NCT00782626|E1|Reported Event|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
520035|NCT00782639|B3|Baseline|Total|Total of all reporting groups
520036|NCT00782639|B2|Baseline|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
520037|NCT00782639|B1|Baseline|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
520038|NCT00782639|P2|Participant Flow|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
520039|NCT00782639|P1|Participant Flow|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
520040|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 milligrams of iodine per milliliter [mgI/mL] concentration)
520041|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 milligrams of iodine per milliliter [mgI/mL] concentration)
520042|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
520043|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
520044|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
520045|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
520046|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
520047|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
520048|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
520049|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
520050|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
520051|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
520052|NCT00782639|E2|Reported Event|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
520053|NCT00782639|E1|Reported Event|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
520054|NCT00782717|B3|Baseline|Total|Total of all reporting groups
520055|NCT00782717|B2|Baseline|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
520056|NCT00782717|B1|Baseline|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
520057|NCT00782717|P2|Participant Flow|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
520058|NCT00782717|P1|Participant Flow|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
520059|NCT00782717|O2|Outcome|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
520060|NCT00782717|O1|Outcome|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
520061|NCT00782717|O2|Outcome|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
520062|NCT00782717|O1|Outcome|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
520063|NCT00782717|E2|Reported Event|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
520064|NCT00782717|E1|Reported Event|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
520065|NCT00775944|B5|Baseline|Total|Total of all reporting groups
520066|NCT00775944|B4|Baseline|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
520067|NCT00775944|B3|Baseline|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
520068|NCT00775944|B2|Baseline|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
520069|NCT00775944|B1|Baseline|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
520070|NCT00775944|P4|Participant Flow|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
520071|NCT00775944|P3|Participant Flow|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
520072|NCT00775944|P2|Participant Flow|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
520073|NCT00775944|P1|Participant Flow|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
520074|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
520075|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
520077|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
520078|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
520079|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
520080|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
520081|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
520082|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
520083|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
520084|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
520085|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
520086|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
520087|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
520088|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
520089|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
520090|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
520091|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
520092|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
520093|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
520094|NCT00775944|E4|Reported Event|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
520095|NCT00775944|E3|Reported Event|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
520096|NCT00775944|E2|Reported Event|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
520097|NCT00775944|E1|Reported Event|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
520098|NCT00775983|B3|Baseline|Total|Total of all reporting groups
520099|NCT00775983|B2|Baseline|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
520100|NCT00775983|B1|Baseline|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
520101|NCT00775983|P2|Participant Flow|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
520102|NCT00775983|P1|Participant Flow|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
520103|NCT00775983|O2|Outcome|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
520104|NCT00775983|O1|Outcome|Overnight Laminaria|Overnight laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
520105|NCT00775983|O2|Outcome|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
520106|NCT00775983|O1|Outcome|Overnight Laminaria|Overnight laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
520107|NCT00775983|E2|Reported Event|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
520108|NCT00775983|E1|Reported Event|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
520109|NCT00776009|B7|Baseline|Total|Total of all reporting groups
520292|NCT00783614|E3|Reported Event|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
520294|NCT00783614|E1|Reported Event|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
520110|NCT00776009|B6|Baseline|Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
520111|NCT00776009|B5|Baseline|Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
520112|NCT00776009|B4|Baseline|Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
520113|NCT00776009|B3|Baseline|Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
520114|NCT00776009|B2|Baseline|Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
520115|NCT00776009|B1|Baseline|Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
520116|NCT00776009|P6|Participant Flow|Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
520117|NCT00776009|P5|Participant Flow|Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
520118|NCT00776009|P4|Participant Flow|Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
520119|NCT00776009|P3|Participant Flow|Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
520120|NCT00776009|P2|Participant Flow|Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
520121|NCT00776009|P1|Participant Flow|Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
520122|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
520123|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
520124|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
520125|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
520126|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
520127|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
520128|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
520129|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
520130|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
520131|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
520132|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
520133|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
520134|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
520206|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520135|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
520136|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
520137|NCT00776009|E3|Reported Event|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
520138|NCT00776009|E2|Reported Event|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
520139|NCT00776009|E1|Reported Event|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
520140|NCT00776100|B3|Baseline|Total|Total of all reporting groups
520141|NCT00776100|B2|Baseline|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
520142|NCT00776100|B1|Baseline|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
520143|NCT00776100|P2|Participant Flow|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
520144|NCT00776100|P1|Participant Flow|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
520145|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
520146|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
520147|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
520148|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
520149|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
520150|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
520151|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
520152|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
520153|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
520154|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
520155|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
520156|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
520157|NCT00776100|E2|Reported Event|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
520158|NCT00776100|E1|Reported Event|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
520159|NCT00782821|B5|Baseline|Total|Total of all reporting groups
520160|NCT00782821|B4|Baseline|RATG/Rituxan/Velcade|"Thymoglobulin x 4 doses (1.5mg/kg IV)+ Rituximab 200mg/m2 IV + Velcade (1.3 mg/m2 IVP)
Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
520161|NCT00782821|B3|Baseline|RATG/Velcade|"Thymoglobulin (RATG) x 5 doses (1.5mg/kg IV) + Velcade (1.3 mg/m2 IVP)
Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
520162|NCT00782821|B2|Baseline|RATG/Rituxan|"Thymoglobulin (RATG) x 5 doses (1.5mg/kg IV)+ Rituximab 375mg/m2 IV
Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
520163|NCT00782821|B1|Baseline|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin (RATG) x 6 doses (1.5mg/kg IV) Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily).
520164|NCT00782821|P4|Participant Flow|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses (1.5mg/kg IV). + Rituximab 200mg/m2 IV + Bortezomib 1.3 mg/m2 IVP Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily). Patients randomized to Arm C or D will receive 1.3 mg/m2 via IVP over 3-5 minutes on POD 0, 3, 7 and 10. The dose administered on POD 0 will be administered before pre-operatively before the pre-operative dose of methylprednisolone.
520207|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520208|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520209|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520293|NCT00783614|E2|Reported Event|ART and Placebo|Start ART immediately and initiate placebo pill daily
520165|NCT00782821|P3|Participant Flow|RATG/Velcade|"Thymoglobulin x 5 doses (1.5mg/kg IV) + Velcade (1.3 mg/m2 IVP)
Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily). Patients randomized to Arm C or D will receive 1.3 mg/m2 via IVP over 3-5 minutes on POD 0, 3, 7 and 10. The dose administered on POD 0 will be administered before pre-operatively before the pre-operative dose of methylprednisolone."
520166|NCT00782821|P2|Participant Flow|RATG/Rituxan|"Thymoglobulin x 5 doses (1.5mg/kg IV) + Rituximab 375mg/m2 IV
Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
520167|NCT00782821|P1|Participant Flow|Rabbit Antithymocyte Globulin (rATG)|"Thymoglobulin x 6 doses (1.5mg/kg IV).
Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
520168|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|"Rabbit Antithymocyte Globulin (RATG) / Rituxan / Velcade
RATG/Velcade: RATG/Velcade"
520169|NCT00782821|O3|Outcome|RATG/Velcade|"Rabbit Antithymocyte Globulin (RATG) /Velcade
RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
520170|NCT00782821|O2|Outcome|RATG/Rituxan|"Rabbit Antithymocyte Globulin (RATG)/Rituxan
RATG/Rituxan: RATG/Rituxan
RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
520171|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"Rabbit Antithymocyte Globulin (RATG)
Rabbit Antithymocyte Globulin (RATG): RATG"
520172|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Bortezomib
520173|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
520174|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
520175|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin (RATG) x 6 doses (1.5mg/kg IV)
520176|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Bortezomib
520177|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Bortezomib
520178|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
520179|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
520180|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Velcade
520181|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
520182|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
520183|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
520184|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Velcade
520185|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
520186|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
520187|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
520188|NCT00782821|E4|Reported Event|RATG/Rituxan/Velcade|"Rabbit Antithymocyte Globulin (RATG) / Rituxan / Velcade
RATG/Velcade: RATG/Velcade"
520189|NCT00782821|E3|Reported Event|RATG/Velcade|"Rabbit Antithymocyte Globulin (RATG) /Velcade
RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
520190|NCT00782821|E2|Reported Event|RATG/Rituxan|"Rabbit Antithymocyte Globulin (RATG)/Rituxan
RATG/Rituxan: RATG/Rituxan
RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
520191|NCT00782821|E1|Reported Event|Rabbit Antithymocyte Globulin (RATG)|"Rabbit Antithymocyte Globulin (RATG)
Rabbit Antithymocyte Globulin (RATG): RATG"
520192|NCT00782834|B1|Baseline|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
520193|NCT00782834|P1|Participant Flow|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
520194|NCT00782834|O1|Outcome|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
520195|NCT00782834|O1|Outcome|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
520196|NCT00782834|E1|Reported Event|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
520197|NCT00783094|B4|Baseline|Total|Total of all reporting groups
520198|NCT00783094|B3|Baseline|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520199|NCT00783094|B2|Baseline|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520200|NCT00783094|B1|Baseline|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520201|NCT00783094|P3|Participant Flow|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520202|NCT00783094|P2|Participant Flow|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520203|NCT00783094|P1|Participant Flow|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520204|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520205|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520291|NCT00783614|E4|Reported Event|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
520210|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520211|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520212|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520213|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520214|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520215|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520216|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520217|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520218|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520219|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520220|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520221|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520222|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520223|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520224|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520225|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520226|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520227|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520228|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520229|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520230|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520231|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520232|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520233|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520234|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520235|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520236|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520237|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520238|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520239|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520240|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520241|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520242|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520243|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520244|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520245|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520246|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520247|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520248|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
528275|NCT00802672|P2|Participant Flow|Reference Product|Loprox Cream
520249|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520250|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520251|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520252|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520253|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520254|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520255|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520256|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520257|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520258|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520259|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520260|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520261|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520262|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520263|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520264|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520265|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520266|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520267|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520268|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520269|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
520270|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520271|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
520272|NCT00783094|E6|Reported Event|Placebo: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received placebo in the double-blind phase.
520273|NCT00783094|E5|Reported Event|Tadalafil 5 mg: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 5 mg tadalafil in the double-blind phase.
520274|NCT00783094|E4|Reported Event|Tadalafil 2.5 mg: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 2.5 mg tadalafil in the double-blind phase.
520275|NCT00783094|E3|Reported Event|Placebo - Double-Blind Phase|"Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase."
520276|NCT00783094|E2|Reported Event|Tadalafil 5 mg - Double-Blind Phase|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.
520277|NCT00783094|E1|Reported Event|Tadalafil 2.5 mg - Double-Blind Phase|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks in the Open-Label Phase.
520278|NCT00783614|B5|Baseline|Total|Total of all reporting groups
520279|NCT00783614|B4|Baseline|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
520280|NCT00783614|B3|Baseline|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
520281|NCT00783614|B2|Baseline|ART and Placebo|Start ART immediately and initiate placebo pill daily
520282|NCT00783614|B1|Baseline|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
520283|NCT00783614|P4|Participant Flow|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
520284|NCT00783614|P3|Participant Flow|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
520285|NCT00783614|P2|Participant Flow|ART and Placebo|Start ART immediately and initiate placebo pill daily
520286|NCT00783614|P1|Participant Flow|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
520287|NCT00783614|O4|Outcome|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
520288|NCT00783614|O3|Outcome|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
520289|NCT00783614|O2|Outcome|ART and Placebo|Start ART immediately and initiate placebo pill daily
520290|NCT00783614|O1|Outcome|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
528276|NCT00802672|P1|Participant Flow|Test Product|Ciclopirox cream
520296|NCT00783692|B3|Baseline|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
520297|NCT00783692|B2|Baseline|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
520298|NCT00783692|B1|Baseline|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2.
520299|NCT00783692|P7|Participant Flow|Maintenance Phase: Non-Responders|Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
520300|NCT00783692|P6|Participant Flow|Maintenance Phase: Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
520301|NCT00783692|P5|Participant Flow|Maintenance Phase: Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
520302|NCT00783692|P4|Participant Flow|Maintenance Phase: Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
520303|NCT00783692|P3|Participant Flow|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
520304|NCT00783692|P2|Participant Flow|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
520305|NCT00783692|P1|Participant Flow|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
520306|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
520307|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
520308|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
520309|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
520310|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
520311|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
520312|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
520313|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
520314|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
520315|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
520316|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
520317|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
520318|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
520319|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
520320|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
520321|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
520322|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
528277|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
520323|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
520324|NCT00783692|E3|Reported Event|VDZ/VDZ|Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
520325|NCT00783692|E2|Reported Event|VDZ/PBO|Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
520326|NCT00783692|E1|Reported Event|Placebo|Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
520327|NCT00783705|B3|Baseline|Total|Total of all reporting groups
520328|NCT00783705|B2|Baseline|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520329|NCT00783705|B1|Baseline|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520330|NCT00783705|P2|Participant Flow|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520331|NCT00783705|P1|Participant Flow|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520332|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520333|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520334|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520335|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520336|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520337|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520338|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520339|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520340|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520341|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520342|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520343|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520344|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520345|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520346|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520347|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520348|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520349|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520350|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520351|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520352|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520353|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520354|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520355|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520356|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520357|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520358|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520431|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520435|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520359|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520360|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520361|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520362|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520363|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520364|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520365|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520366|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520367|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520368|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520369|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520370|NCT00783705|E2|Reported Event|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520371|NCT00783705|E1|Reported Event|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
520372|NCT00783718|B4|Baseline|Total|Total of all reporting groups
520373|NCT00783718|B3|Baseline|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
520374|NCT00783718|B2|Baseline|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
520375|NCT00783718|B1|Baseline|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
520376|NCT00783718|P7|Participant Flow|Maintenance Phase: Non-responders|Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
520377|NCT00783718|P6|Participant Flow|Maintenance Phase: Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
520378|NCT00783718|P5|Participant Flow|Maintenance Phase: Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
520379|NCT00783718|P4|Participant Flow|Maintenance Phase: Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
520380|NCT00783718|P3|Participant Flow|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
520381|NCT00783718|P2|Participant Flow|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
520382|NCT00783718|P1|Participant Flow|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
520383|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
520384|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
520385|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
520386|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
520387|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
520388|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
520432|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520389|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
520390|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
520391|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
520392|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
520393|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
520394|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
520395|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
520396|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
520397|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
520398|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
520399|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
520400|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
520401|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
520402|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
520403|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
520404|NCT00783718|E3|Reported Event|Vedolizumab|Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
520405|NCT00783718|E2|Reported Event|Vedolizumab Then Placebo|Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
520406|NCT00783718|E1|Reported Event|Placebo|Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
520407|NCT00783796|B1|Baseline|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520408|NCT00783796|P1|Participant Flow|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
520409|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520410|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520411|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520412|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520413|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520414|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520415|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520416|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520417|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520418|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520419|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520420|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520421|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520422|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520423|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520424|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520425|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520426|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520427|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520428|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520429|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520430|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520436|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520437|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520438|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520439|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520440|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520441|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520442|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520443|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520444|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520445|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520446|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520447|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520448|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520449|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520450|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520451|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520452|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520453|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520454|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520455|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520456|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520457|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520458|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520459|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520460|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520461|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520462|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520463|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520464|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520465|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520466|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520467|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520468|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520469|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520470|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520471|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520472|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520473|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520474|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520475|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520476|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520477|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520478|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520479|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520480|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520481|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520482|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520483|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520484|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520485|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520486|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520487|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520488|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520489|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520490|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520491|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520492|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520493|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
520494|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
520495|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
520496|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
522397|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
520497|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
520498|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
520499|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
520500|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
520501|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
520502|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
520503|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
520504|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
520505|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects
520506|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects
520507|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520508|NCT00783796|E1|Reported Event|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
520509|NCT00783835|B1|Baseline|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520510|NCT00783835|P1|Participant Flow|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520511|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520512|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520513|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520514|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520515|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520516|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520517|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520518|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520519|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520520|NCT00783835|E1|Reported Event|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
520521|NCT00783952|B1|Baseline|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines
'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.
Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
520575|NCT00784134|P1|Participant Flow|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
529604|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
520576|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520522|NCT00783952|P1|Participant Flow|Mixed Venous Oxygen and Calculation of Saturation|"Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.
Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
520523|NCT00783952|O2|Outcome|Patients With Cerebral/Somatic Tissue Oximeter Device|"Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.
Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
520524|NCT00783952|O1|Outcome|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines
'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.
Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
520525|NCT00783952|E1|Reported Event|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines
'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.
Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
520526|NCT00783965|B3|Baseline|Total|Total of all reporting groups
520527|NCT00783965|B2|Baseline|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.
placebo : Applied to the skin
tazarotene : Applied to the skin"
520528|NCT00783965|B1|Baseline|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.
placebo : Applied to the skin
tazarotene : Applied to the skin"
520529|NCT00783965|P2|Participant Flow|Arm II|Vehicle (placebo) first, then 0.1% tazarotene cream
520530|NCT00783965|P1|Participant Flow|Arm I|0.1% tazarotene cream first, then placebo
520531|NCT00783965|O2|Outcome|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.
placebo : Applied to the skin
tazarotene : Applied to the skin"
520532|NCT00783965|O1|Outcome|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.
placebo : Applied to the skin
tazarotene : Applied to the skin"
520533|NCT00783965|O2|Outcome|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.
placebo : Applied to the skin
tazarotene : Applied to the skin"
520534|NCT00783965|O1|Outcome|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.
placebo : Applied to the skin
tazarotene : Applied to the skin"
520535|NCT00783965|E2|Reported Event|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.
placebo : Applied to the skin
tazarotene : Applied to the skin"
520536|NCT00783965|E1|Reported Event|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.
placebo : Applied to the skin
tazarotene : Applied to the skin"
520537|NCT00784030|B3|Baseline|Total|Total of all reporting groups
520538|NCT00784030|B2|Baseline|Healthy Patients|
520539|NCT00784030|B1|Baseline|Polycystic Kidney Disease (PKD) Patients|
520540|NCT00784030|P2|Participant Flow|Healthy Patients|
520541|NCT00784030|P1|Participant Flow|Polycystic Kidney Disease (PKD) Patients|Patients who present with polycystic kidney disease (PKD)
520542|NCT00784030|O2|Outcome|Healthy Controls|Healthy Controls
520543|NCT00784030|O1|Outcome|Polycystic Kidney Disease Patients|Patients with Autosomal Dominant Polycystic Kidney Disease
520544|NCT00784030|E2|Reported Event|Healthy Controls|Healthy Controls
520545|NCT00784030|E1|Reported Event|Polycystic Kidney Disease Patients|Patients with Autosomal Dominant Polycystic Kidney Disease
520546|NCT00784095|B4|Baseline|Total|Total of all reporting groups
520547|NCT00784095|B3|Baseline|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
520548|NCT00784095|B2|Baseline|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD."
520549|NCT00784095|B1|Baseline|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
520550|NCT00784095|P3|Participant Flow|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
520551|NCT00784095|P2|Participant Flow|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD."
520552|NCT00784095|P1|Participant Flow|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
520553|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
520554|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD."
520555|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
520556|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
520557|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD."
520558|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
520559|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
520560|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD."
520561|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
520562|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
520563|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD."
520564|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
520565|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
520566|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD."
520567|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
520568|NCT00784095|E3|Reported Event|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
520569|NCT00784095|E2|Reported Event|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects listened to a non-guided relaxation CD."
520570|NCT00784095|E1|Reported Event|Preparation and Completion|"Subjects in the first group (treatment) met with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy.
Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
520571|NCT00784134|B3|Baseline|Total|Total of all reporting groups
520572|NCT00784134|B2|Baseline|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520573|NCT00784134|B1|Baseline|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520574|NCT00784134|P2|Participant Flow|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520921|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520577|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520578|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520579|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520580|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520581|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520582|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520583|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520584|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520585|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520586|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520587|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520588|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520589|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520590|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520591|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520592|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520593|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520594|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520595|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520596|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520597|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520598|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520599|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520600|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520601|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520602|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520603|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520604|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520605|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520922|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520606|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520607|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520608|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520609|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520610|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520611|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520612|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520613|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520614|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520615|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520616|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520617|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520618|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520619|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520620|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520621|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520622|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520623|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520624|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520625|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520626|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520627|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520628|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520629|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520630|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520631|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520632|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520633|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520634|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520635|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520923|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520636|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520637|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520638|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520639|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520640|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520641|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520642|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520643|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520644|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520645|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520646|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520647|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520648|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520649|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520650|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520651|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520652|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520653|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520654|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520655|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520656|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520657|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520658|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520659|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520660|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520661|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520662|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520663|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520664|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520665|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520924|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520666|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520667|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520668|NCT00784134|E2|Reported Event|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520669|NCT00784134|E1|Reported Event|Alteplase|"Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
520670|NCT00784147|B3|Baseline|Total|Total of all reporting groups
520671|NCT00784147|B2|Baseline|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
520672|NCT00784147|B1|Baseline|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
520673|NCT00784147|P2|Participant Flow|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
520674|NCT00784147|P1|Participant Flow|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
520675|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
520676|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
520677|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
520678|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
520679|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
520680|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
520681|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
520682|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
520683|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
520684|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
520685|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
520686|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
520687|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
520688|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
520689|NCT00784147|E2|Reported Event|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
520690|NCT00784147|E1|Reported Event|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
520691|NCT00784238|B1|Baseline|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
520692|NCT00784238|P1|Participant Flow|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
520693|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520694|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520695|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
520696|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520697|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520925|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520731|NCT00784238|E1|Reported Event|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
520732|NCT00784277|B5|Baseline|Total|Total of all reporting groups
520698|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
520699|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520700|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520701|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
520702|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520703|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520704|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
520705|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520706|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520707|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
520708|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520709|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520710|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
520711|NCT00784238|O1|Outcome|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
520712|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520713|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520730|NCT00784238|O1|Outcome|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
520926|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520714|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
520715|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520716|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520717|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
520718|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520719|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520720|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
520721|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520722|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520723|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
520724|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520725|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520726|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
520727|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
520728|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
520729|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
521103|NCT00784875|B1|Baseline|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
520733|NCT00784277|B4|Baseline|Oxycodone|IR Treatment : 10mg capsule for 14 days
520734|NCT00784277|B3|Baseline|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
520735|NCT00784277|B2|Baseline|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
520736|NCT00784277|B1|Baseline|Placebo|IR Treatment : 1 capsule for 14 days
520737|NCT00784277|P7|Participant Flow|Oxycodone CR|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
520738|NCT00784277|P6|Participant Flow|Tapentadol ER|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
520739|NCT00784277|P5|Participant Flow|Placebo ER|ER Treatment : Tablets and capsules 2 x a day for 28 days
520740|NCT00784277|P4|Participant Flow|Oxycodone|IR Treatment : 10mg for 14 days
520741|NCT00784277|P3|Participant Flow|Tapentadol 75 mg|IR Treatment : 75mg for 14 days
520742|NCT00784277|P2|Participant Flow|Tapentadol 50 mg|IR Treatment : 50mg for 14 days
520743|NCT00784277|P1|Participant Flow|Placebo|IR Treatment : 1 capsule for 14 days
520744|NCT00784277|O4|Outcome|Oxycodone|IR Treatment : 10mg capsule for 14 days
520745|NCT00784277|O3|Outcome|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
520746|NCT00784277|O2|Outcome|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
520747|NCT00784277|O1|Outcome|Placebo|IR Treatment : 1 capsule for 14 days
520748|NCT00784277|O4|Outcome|Oxycodone|IR Treatment : 10mg capsule for 14 days
520749|NCT00784277|O3|Outcome|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
520750|NCT00784277|O2|Outcome|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
520751|NCT00784277|O1|Outcome|Placebo|IR Treatment : 1 capsule for 14 days
520752|NCT00784277|E7|Reported Event|Oxycodone CR|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
520753|NCT00784277|E6|Reported Event|Tapentadol ER|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
520754|NCT00784277|E5|Reported Event|Placebo ER|ER Treatment : Tablets and capsules 2 x a day for 28 days
520755|NCT00784277|E4|Reported Event|Oxycodone|IR Treatment : 10mg for 14 days
520756|NCT00784277|E3|Reported Event|Tapentadol 75 mg|IR Treatment : 75mg for 14 days
520757|NCT00784277|E2|Reported Event|Tapentadol 50 mg|IR Treatment : 50mg for 14 days
520758|NCT00784277|E1|Reported Event|Placebo|IR Treatment : 1 capsule for 14 days
520759|NCT00784368|B4|Baseline|Total|Total of all reporting groups
520760|NCT00784368|B3|Baseline|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520761|NCT00784368|B2|Baseline|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520762|NCT00784368|B1|Baseline|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520763|NCT00784368|P3|Participant Flow|FN (Switched Treatment)|Participants with febrile (with fever) neutropenia (a decrease in white blood cells) (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520764|NCT00784368|P2|Participant Flow|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous (into the vein) infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520765|NCT00784368|P1|Participant Flow|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520766|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520767|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520768|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520815|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
520817|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
520818|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
520769|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520770|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520771|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520772|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520773|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520774|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520775|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520776|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520777|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520778|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520779|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520780|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520781|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520782|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520783|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520784|NCT00784368|O1|Outcome|SFI (JK1211 Monotherapy)|Participants with deep-seated mycosis (SFI) received JK1211 orally (taken by mouth; to be swallowed) in the dose range of 20 milliliter per day (ml/day) to 40 ml/day for 12 weeks as per Investigator’s discretion.
520785|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520786|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520787|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520788|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520789|NCT00784368|O3|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520790|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520791|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520792|NCT00784368|O3|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520793|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520794|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520795|NCT00784368|E3|Reported Event|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520796|NCT00784368|E2|Reported Event|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520797|NCT00784368|E1|Reported Event|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
520798|NCT00784459|B3|Baseline|Total|Total of all reporting groups
520799|NCT00784459|B2|Baseline|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
520800|NCT00784459|B1|Baseline|Placebo|Placebo : Treatment with Placebo, IV
520801|NCT00784459|P2|Participant Flow|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
520802|NCT00784459|P1|Participant Flow|Placebo|Placebo : Treatment with Placebo, IV
520803|NCT00784459|O2|Outcome|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
520804|NCT00784459|O1|Outcome|Placebo|Placebo : Treatment with Placebo, IV
520805|NCT00784459|O2|Outcome|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
520806|NCT00784459|O1|Outcome|Placebo|Placebo : Treatment with Placebo, IV
520807|NCT00784459|E2|Reported Event|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
520808|NCT00784459|E1|Reported Event|Placebo|Placebo : Treatment with Placebo, IV
520809|NCT00784550|B3|Baseline|Total|Total of all reporting groups
520810|NCT00784550|B2|Baseline|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
520811|NCT00784550|B1|Baseline|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
520812|NCT00784550|P2|Participant Flow|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
520813|NCT00784550|P1|Participant Flow|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
520814|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
520816|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
520819|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
520820|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
520821|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
520822|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
520823|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
520824|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
520825|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
520826|NCT00784550|E2|Reported Event|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
520827|NCT00784550|E1|Reported Event|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
520828|NCT00784563|B4|Baseline|Total|Total of all reporting groups
520829|NCT00784563|B3|Baseline|Continuous-Year 3|Participants who were assigned to continuous training in the third year of the study without randomization. Due to potentially increased risk of knee pain without additional fitness benefits, we dropped the interval group for the third year.
520830|NCT00784563|B2|Baseline|Interval Training -Years 1 & 2|Participants who were randomized to interval training in the first 2 years of the study.
520831|NCT00784563|B1|Baseline|Continuous Training-Years 1 & 2|Participants who were randomized to continuous training in the first 2 years of the study.
520832|NCT00784563|P3|Participant Flow|Continuous Training - Year 3|Participant were assigned to continuous training without randomization.
520833|NCT00784563|P2|Participant Flow|Interval Training - Years 1 & 2|The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. Participants were asked to wear electronic heart rate and walking speed monitors (Polar RS400, Kempele, Finland) and fill out diaries for each session. Interval trainees alternated every 3 minutes between slower (60-70% of HRmax) and faster (80-90% of HRmax) walking.
520834|NCT00784563|P1|Participant Flow|Continuous Training - Years 1 & 2|The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. Participants were asked to wear electronic heart rate and walking speed monitors (Polar RS400, Kempele, Finland) and fill out diaries for each session. The goal for continuous training was to remain within 70-80% of HRmax throughout the session.
520835|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
520836|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
520837|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
520838|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
520839|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
520840|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
520841|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
520842|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
520843|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
520844|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
520845|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
520846|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
520847|NCT00784563|E2|Reported Event|Interval Training|This group consists of 22 subjects who were randomized to interval training in the first two years of the study. No subjects were assigned to the interval training in the third year of the study.
520848|NCT00784563|E1|Reported Event|Continuous Training|This group consists of 21 subjects who were randomized to continuous training in the first two years of the study and 17 subjects who were assigned to continuous training without randomization in the third year of the study. Thus, total group size is 38.
520849|NCT00784654|B1|Baseline|All Enrolled Subjects|
520850|NCT00784654|P3|Participant Flow|Placebo (Randomized Period)|After the Open-label Period, subjects were randomized to receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520851|NCT00784654|P2|Participant Flow|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|After the Open-label Period, subjects were randomized to receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
530452|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
520880|NCT00784654|E3|Reported Event|Placebo (Randomized Period)|After the Open-label Period, subjects were randomized to receive placebo once-daily orally at approximately 7:00 AM for up to 6 weeks.
521108|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
520852|NCT00784654|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
520853|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520854|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520855|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
520856|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520857|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520858|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520859|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520860|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
520861|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520862|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520863|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
520864|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520865|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520866|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
520867|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520868|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520869|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
520870|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
520871|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520872|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520873|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
520874|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
520875|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520876|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
520877|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
520878|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.
520879|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.
520881|NCT00784654|E2|Reported Event|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|After the Open-label Period, subjects were randomized to receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM for up to 6 weeks.
520882|NCT00784654|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM).
520883|NCT00784719|B8|Baseline|Total|Total of all reporting groups
520884|NCT00784719|B7|Baseline|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520885|NCT00784719|B6|Baseline|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520886|NCT00784719|B5|Baseline|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520887|NCT00784719|B4|Baseline|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520888|NCT00784719|B3|Baseline|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520889|NCT00784719|B2|Baseline|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520890|NCT00784719|B1|Baseline|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520891|NCT00784719|P7|Participant Flow|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520892|NCT00784719|P6|Participant Flow|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520893|NCT00784719|P5|Participant Flow|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520894|NCT00784719|P4|Participant Flow|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520895|NCT00784719|P3|Participant Flow|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520896|NCT00784719|P2|Participant Flow|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520897|NCT00784719|P1|Participant Flow|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520898|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520899|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520900|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520901|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520902|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520903|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520904|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520905|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520906|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520907|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520908|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520909|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520910|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520911|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520912|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520913|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520914|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520915|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520916|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520917|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520918|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520919|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520920|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
521107|NCT00784875|P1|Participant Flow|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
520927|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520928|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520929|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520930|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520931|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520932|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520933|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520934|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520935|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520936|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520937|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520938|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520939|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520940|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520941|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520942|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520943|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520944|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520945|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520946|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520947|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520948|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520949|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520950|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520951|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520952|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520953|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520954|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520955|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520956|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520957|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520958|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520959|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520960|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520961|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520962|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520963|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520964|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520965|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520966|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520967|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520968|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
521104|NCT00784875|P4|Participant Flow|Placebo|Participants received placebo in a 2-week treatment period.
520969|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520970|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520971|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520972|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520973|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520974|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520975|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520976|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520977|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520978|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520979|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520980|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520981|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520982|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520983|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520984|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520985|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520986|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520987|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520988|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520989|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520990|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520991|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520992|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
520993|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
520994|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
520995|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
520996|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
520997|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
520998|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
520999|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
521000|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
521001|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
521002|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
521003|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
521004|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
521005|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
521006|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
521007|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
521008|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
521009|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
521010|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
521105|NCT00784875|P3|Participant Flow|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
521011|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
521012|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
521013|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
521014|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
521015|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
521016|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
521017|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
521018|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
521019|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
521020|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
521021|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
521022|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
521023|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
521024|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
521025|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
521026|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
521027|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
521028|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
521029|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
521030|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
521031|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
521032|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
521033|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
521034|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
521035|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
521036|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
521037|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
521038|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
521039|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
521040|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
521041|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
521042|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
521043|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
521044|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
521045|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
521046|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
521047|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
521048|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
521049|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
521050|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
521051|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
521052|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
521106|NCT00784875|P2|Participant Flow|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
521053|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
521054|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
521055|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
521056|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
521057|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
521058|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
521059|NCT00784719|E7|Reported Event|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
521060|NCT00784719|E6|Reported Event|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
521061|NCT00784719|E5|Reported Event|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
521062|NCT00784719|E4|Reported Event|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
521063|NCT00784719|E3|Reported Event|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
521064|NCT00784719|E2|Reported Event|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
521065|NCT00784719|E1|Reported Event|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
521066|NCT00784784|B3|Baseline|Total|Total of all reporting groups
521067|NCT00784784|B2|Baseline|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
521068|NCT00784784|B1|Baseline|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
521069|NCT00784784|P2|Participant Flow|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
521070|NCT00784784|P1|Participant Flow|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
521071|NCT00784784|O2|Outcome|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
521072|NCT00784784|O1|Outcome|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
521073|NCT00784784|O2|Outcome|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
521074|NCT00784784|O1|Outcome|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
521075|NCT00784784|E2|Reported Event|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
521076|NCT00784784|E1|Reported Event|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
521077|NCT00784810|B3|Baseline|Total|Total of all reporting groups
521078|NCT00784810|B2|Baseline|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
521079|NCT00784810|B1|Baseline|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
521080|NCT00784810|P2|Participant Flow|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
521081|NCT00784810|P1|Participant Flow|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
521082|NCT00784810|O2|Outcome|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
521083|NCT00784810|O1|Outcome|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
521084|NCT00784810|O2|Outcome|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
521085|NCT00784810|O1|Outcome|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
521086|NCT00784810|E2|Reported Event|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
521087|NCT00784810|E1|Reported Event|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
521088|NCT00784836|B1|Baseline|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
521089|NCT00784836|P1|Participant Flow|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
521090|NCT00784836|O1|Outcome|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
521091|NCT00784836|O1|Outcome|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
521092|NCT00784836|E1|Reported Event|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
521093|NCT00784849|B1|Baseline|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
521094|NCT00784849|P1|Participant Flow|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
521095|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
521096|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
521097|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
521098|NCT00784849|E1|Reported Event|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
521099|NCT00784875|B5|Baseline|Total|Total of all reporting groups
521100|NCT00784875|B4|Baseline|Placebo|Participants received placebo in Period B (2-week treatment period).
521101|NCT00784875|B3|Baseline|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521102|NCT00784875|B2|Baseline|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
530569|NCT00807885|B2|Baseline|Tape-secured 24 ga Teflon Catheter|
521109|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
521110|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
521111|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
521112|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
521113|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
521114|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
521115|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period
521116|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
521117|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
521118|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
521119|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
521120|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
521121|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
521122|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
521123|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
521124|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
521125|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
521126|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
521127|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
521128|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
521129|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
521130|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
521131|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
521132|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
521133|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
521134|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
521135|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
521136|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
521137|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
521138|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
521139|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
521140|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
521141|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
521142|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
521143|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
521144|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521145|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521146|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521147|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521148|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
521149|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
521150|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
521151|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
521152|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521153|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521154|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521155|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521156|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521157|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521158|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521159|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521160|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521161|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521162|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521163|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521164|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521165|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521166|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521167|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521168|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521169|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521170|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521171|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521172|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521173|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521174|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521175|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521176|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521177|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521178|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521179|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521180|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521181|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521182|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521183|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521184|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521185|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521186|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521187|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521188|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521189|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521190|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521191|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521192|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521193|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521194|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521195|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521196|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521197|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521198|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521199|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521200|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521201|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521202|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521203|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521204|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
521205|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521206|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
521207|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
521208|NCT00784875|E12|Reported Event|Period D - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period D (2-week treatment period).
521209|NCT00784875|E11|Reported Event|Period D - Placebo|Patients received placebo in Period D (2-week treatment period).
521210|NCT00784875|E10|Reported Event|Period D - LY2624803 3 mg|Patients received LY2624803 3 mg in Period D (2-week treatment period).
521211|NCT00784875|E9|Reported Event|Period D - LY2624803 1 mg|Patients received LY2624803 1 mg in Period D (2-week treatment period.
521212|NCT00784875|E8|Reported Event|Period C - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period C (2-week treatment period).
521213|NCT00784875|E7|Reported Event|Period C - Placebo|Patients received placebo in Period C (2-week treatment period).
521214|NCT00784875|E6|Reported Event|Period C - LY2624803 3 mg|Patients received LY2624803 3 mg in Period C (2-week treatment period).
521215|NCT00784875|E5|Reported Event|Period C - LY2624803 1 mg|Patients received LY2624803 1 mg in Period C (2-week treatment period.
521216|NCT00784875|E4|Reported Event|Period B - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
521217|NCT00784875|E3|Reported Event|Period B - Placebo|Patients received placebo in Period B (2-week treatment period).
521218|NCT00784875|E2|Reported Event|Period B - LY2624803 3 mg|Patients received LY2624803 3 mg in Period B (2-week treatment period).
521219|NCT00784875|E1|Reported Event|Period B - LY2624803 1 mg|Patients received LY2624803 1 mg in Period B (2-week treatment period.
521363|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521220|NCT00784927|B1|Baseline|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:
375 mg/m^2 Rituximab IV on day 1.
20 mg Lenalidomide taken orally on days 1-21.
250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15.
40 mg Dexamethasone orally on days 1, 8, 15, 22."
521221|NCT00784927|P1|Participant Flow|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:
375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21.
250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15.
40 mg Dexamethasone orally on days 1, 8, 15, 22."
521222|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:
375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
521223|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:
375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
521224|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:
375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
521225|NCT00784927|O1|Outcome|Treatment|"Participants with lymphoplasmacytic lymphoma (Waldenstrom’s macroglobulinemia) will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles and analyzed as a separate cohort:
375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22.
rituximab
cyclophosphamide
dexamethasone
lenalidomide"
521226|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:
375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
521227|NCT00784927|E1|Reported Event|Treatment|40 mg Dexamethasone orally on days 1, 8, 15, 22.
521228|NCT00784979|B1|Baseline|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA >/= 20% within the last 12 months; identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
521229|NCT00784979|P1|Participant Flow|CMVIG Followed by PP|MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
521230|NCT00784979|O1|Outcome|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
521231|NCT00784979|E1|Reported Event|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
521232|NCT00785044|B1|Baseline|AdreView™ - Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of ACEs.
521233|NCT00785044|P1|Participant Flow|AdreView™- Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of adverse cardiac events (ACEs).
521234|NCT00785044|O2|Outcome|AdreView™- HF Group (With Adverse Cardiac Events)|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) with ACEs monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG.
521235|NCT00785044|O1|Outcome|AdreView™ - HF Group (With No Adverse Cardiac Events)|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) with no ACEs monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG.
521236|NCT00785044|E1|Reported Event|AdreView™ - Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of ACEs.
521237|NCT00785213|B1|Baseline|Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
521238|NCT00785213|P1|Participant Flow|Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
521239|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
521240|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
521320|NCT00785577|B3|Baseline|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521576|NCT00779259|O2|Outcome|4 Hours After Morning Dose of Quinine on Study Day 11|measured 4 hours after the morning dose of quinine
521241|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
521242|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
521243|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
521244|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
521245|NCT00785213|E3|Reported Event|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects were co-administered a dose of rosiglitazone 4mg and quinine sulfate 648 mg (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
521246|NCT00785213|E2|Reported Event|Quinine Sulfate Alone|On Days 4-7, subjects received a dose of quinine sulfate 648 mg (2 x 324 mg capsules) every 8 hours beginning with the 7:15 a.m. dose on Day 4 and continuing through the 11:15 p.m. dose on Day 7.
521247|NCT00785213|E1|Reported Event|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period.
521248|NCT00785291|B4|Baseline|Total|Total of all reporting groups
521249|NCT00785291|B3|Baseline|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
521250|NCT00785291|B2|Baseline|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521251|NCT00785291|B1|Baseline|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521252|NCT00785291|P3|Participant Flow|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
521253|NCT00785291|P2|Participant Flow|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521254|NCT00785291|P1|Participant Flow|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521255|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
521256|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521257|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521258|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
521259|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521260|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521261|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
521262|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521263|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521264|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
521265|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521266|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521267|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
521268|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521269|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521270|NCT00785291|E3|Reported Event|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
521271|NCT00785291|E2|Reported Event|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521272|NCT00785291|E1|Reported Event|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
521273|NCT00785356|B4|Baseline|Total|Total of all reporting groups
521274|NCT00785356|B3|Baseline|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
521275|NCT00785356|B2|Baseline|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
521276|NCT00785356|B1|Baseline|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
521277|NCT00785356|P1|Participant Flow|All Groups|Proellex 25 mg, Proellex 50 mg, 1placebo
521278|NCT00785356|O3|Outcome|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
521279|NCT00785356|O2|Outcome|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
521280|NCT00785356|O1|Outcome|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
521281|NCT00785356|E3|Reported Event|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
521282|NCT00785356|E2|Reported Event|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
521283|NCT00785356|E1|Reported Event|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
521284|NCT00785486|B1|Baseline|Qualaquin (Quinine) And Midazolam Alone And In Combination|All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other.
521285|NCT00785486|P1|Participant Flow|Qualaquin (Quinine) And Midazolam Alone And In Combination|All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other.
521286|NCT00785486|O2|Outcome|Qualaquin (Quinine) With Midazolam|On day 10 after six days of receiving Qualaquin 324 mg every 8 hours, and after a fast of at least 10 hours, patients received a 2 mg dose of midazolam and 324 mg of Qualaquin (quinine)(Steady state). Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(quinine) in the presence of midazolam over the final dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.
521287|NCT00785486|O1|Outcome|Qualaquin (Quinine) Alone|On the morning of day 9 after taking an oral dose of Qualaquin quinine)324 mg every 8 hours for the prior 5 days (Steady state) and following a fast of at least 10 hours all participants took a an additional 324 mg oral dose of the drug. Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(Quinine) alone over the following dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.
521288|NCT00785486|O4|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin(quinine) 324 mg. Blood was drawn sufficient to characterize AUC inf for 1- hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
521289|NCT00785486|O3|Outcome|Midazolam - Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg . Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
521290|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for 1-hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
521291|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
521321|NCT00785577|B2|Baseline|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521322|NCT00785577|B1|Baseline|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521292|NCT00785486|O4|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for 1-hydroxy midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method.
521293|NCT00785486|O3|Outcome|Midazolam - Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method.
521294|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of 1-hydroxy midazolam as calculated by the linear trapezoidal method.
521295|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of midazolam and 1-hydroxymidazolam
521296|NCT00785486|O6|Outcome|Quinine - Qualaquin (Quinine) With Midazolam|On the morning of day 10 after taking Qualaquin (quinine)capsules 324 mg orally every 8 hours for the prior 6 days, and following a fast of at least 10 hours all study participants co-ingested oral dose s of midazolam 2 mg and their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine)in the presence of midazolam.
521297|NCT00785486|O5|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin(Quinine)|On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg concurrently. On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the Cmax for 1-hydroxy-midazolam in the presence of Qualaquin (quinine) at steady state.
521298|NCT00785486|O4|Outcome|Midazolam - Midazolam With Qualaquin(Quinine)|On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917. 12, 15 and 24 hours to determine Cmax for midazolam in the presence of Qualaquin (qunine)at steady state.
521299|NCT00785486|O3|Outcome|Quinine - Qualaquin(Quinine) Alone|On the morning of day 9 after taking Qualaquin(quinine)capsules 324 mg orally every 8 hours for the prior 5 days, and following a fast of at least 10 hours all study participants received their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine) at this dose.
521300|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for 1-hydroxy-midazolam, the primary metabolite of midazolam
521301|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for midazolam.
521302|NCT00785486|E3|Reported Event|Midazolam With Qualaquin (Quinine) Together|Adverse effects reported on day 10 after participants received 2 mg of midazolam syrup and 324 mg of Qualaquin(quinine)orally.
521303|NCT00785486|E2|Reported Event|Qualaquin (Quinine) Alone|Adverse effects(ADR)while taking Qualaquin(quinine)324 mg alone orally every 8 hours on days 4-11. Results are reported as total for the 7 day period.
521304|NCT00785486|E1|Reported Event|Midazolam Alone|Adverse effects on day 1 after participants received 2mg of midazolam syrup orally.
521305|NCT00785512|B3|Baseline|Total|Total of all reporting groups
521306|NCT00785512|B2|Baseline|Placebo|Matching placebo tablets, oral administration
521307|NCT00785512|B1|Baseline|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
521308|NCT00785512|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
521309|NCT00785512|P1|Participant Flow|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
521310|NCT00785512|O2|Outcome|Placebo|Matching placebo tablets, oral administration
521311|NCT00785512|O1|Outcome|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
521312|NCT00785512|O2|Outcome|Placebo|Matching placebo tablets, oral administration
521313|NCT00785512|O1|Outcome|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
521314|NCT00785512|E3|Reported Event|Placebo|Matching placebo tablets, oral administration
521315|NCT00785512|E2|Reported Event|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
521316|NCT00785512|E1|Reported Event|Single-blind Nebivolol|Pre-randomization 12 week nebivolol treatment.
521317|NCT00785577|B6|Baseline|Total|Total of all reporting groups
521318|NCT00785577|B5|Baseline|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521319|NCT00785577|B4|Baseline|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521323|NCT00785577|P5|Participant Flow|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521324|NCT00785577|P4|Participant Flow|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521325|NCT00785577|P3|Participant Flow|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521326|NCT00785577|P2|Participant Flow|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521327|NCT00785577|P1|Participant Flow|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521328|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521329|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521330|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521331|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521332|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521333|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521334|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521335|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521336|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521337|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521338|NCT00785577|O2|Outcome|Compound 645838 (CLm)|Plasma Compound 645838 concentrations were obtained following daily oral doses of LY545694 21 mg to 105 mg.
521339|NCT00785577|O1|Outcome|LY545694 Clearance (CLp)|Plasma LY545694 concentrations were obtained following daily oral doses of LY545694 21 mg to LY545694 105 mg.
521340|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521341|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521342|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521343|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521344|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521345|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521346|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521347|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521348|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521349|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521350|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521351|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521352|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521353|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521354|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521355|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521356|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521357|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
521358|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521359|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521360|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521361|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521362|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521364|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521365|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521366|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521367|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521368|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521369|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521370|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521371|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521372|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521373|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521374|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521375|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521376|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521377|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521378|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521379|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521380|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521381|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521382|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521383|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521384|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521385|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521386|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521387|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521388|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521389|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521390|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521391|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521392|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521393|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521394|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521395|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521396|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521397|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521398|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521399|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521400|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521401|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521402|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521403|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521404|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521405|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521406|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521407|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521408|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521409|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521410|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521411|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521412|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521413|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521414|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521415|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521416|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521417|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521418|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521419|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521420|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521421|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521422|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521423|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521424|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521425|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521426|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521427|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521428|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521429|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521430|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521431|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521432|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521433|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521434|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521435|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521436|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
521437|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521438|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521439|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521440|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521441|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521442|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521575|NCT00779259|O1|Outcome|1 Hour Before Co-Administered Dose of Theophylline/Quinine|measured 1 hour prior to the 7 am co-administered dose of theophylline and quinine
521443|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521444|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521445|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
521446|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
521447|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521448|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521449|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521450|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
521451|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
521452|NCT00785577|E10|Reported Event|Pregabalin Washout|A one-week washout period in which no pregabalin was taken.
521453|NCT00785577|E9|Reported Event|LY545694 105 mg Washout|A one-week washout period in which no LY545694 105 mg was taken.
521454|NCT00785577|E8|Reported Event|LY545694 49 mg Washout|A one-week washout period in which no LY545694 49 mg was taken.
521455|NCT00785577|E7|Reported Event|LY545694 21 mg Washout|A one-week washout period in which no LY545694 21 mg was taken.
521456|NCT00785577|E6|Reported Event|Placebo Washout|A one-week washout period in which no placebo was taken.
521457|NCT00785577|E5|Reported Event|Pregabalin|Pregabalin thrice daily (TID) oral (po) for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
521458|NCT00785577|E4|Reported Event|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
521459|NCT00785577|E3|Reported Event|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
521460|NCT00785577|E2|Reported Event|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week
521461|NCT00785577|E1|Reported Event|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks
521462|NCT00785629|B5|Baseline|Total|Total of all reporting groups
521463|NCT00785629|B4|Baseline|Placebo|
521464|NCT00785629|B3|Baseline|Lanthanum Carbonate|phosphate binder : starting dose 500mg; titrations to 1500mg QAC
521465|NCT00785629|B2|Baseline|Sevelamer Carbonate|phosphate binder : starting dose 800mg; titrations to 3200mg QAC
521466|NCT00785629|B1|Baseline|Calcium Acetate|phosphate binder : starting dose 667mg;titrations to 2668mg QAC
521467|NCT00785629|P4|Participant Flow|Placebo|
521468|NCT00785629|P3|Participant Flow|Lanthanum Carbonate|phosphate binder : starting dose 500mg; titrations to 1500mg QAC
521469|NCT00785629|P2|Participant Flow|Sevelamer Carbonate|phosphate binder : starting dose 800mg; titrations to 3200mg QAC
521470|NCT00785629|P1|Participant Flow|Calcium Acetate|phosphate binder : starting dose 667mg;titrations to 2668mg QAC
521471|NCT00785629|O2|Outcome|All Placebo Treated Patients|All placebo treated patients
521472|NCT00785629|O1|Outcome|All Active Treated Patients|All actively treated patients
521473|NCT00785629|E4|Reported Event|Calcium Acetate|
521474|NCT00785629|E3|Reported Event|Sevelamer Carbonate|
521475|NCT00785629|E2|Reported Event|Lanthanum Carbonate|
521476|NCT00785629|E1|Reported Event|Placebo|
521477|NCT00785707|B1|Baseline|Cochlear Implant|children less than 24 months at time of cochlear implantation
521478|NCT00785707|P1|Participant Flow|Cochlear Implant|children less than 24 months at time of cochlear implantation
521479|NCT00785707|O1|Outcome|Cochlear Implant|children less than 24 months at time of cochlear implantation
521480|NCT00785707|O1|Outcome|Cochlear Implant|children less than 24 months at time of cochlear implantation
521481|NCT00785707|E1|Reported Event|Cochlear Implant|children less than 24 months at time of cochlear implantation
521482|NCT00785772|B1|Baseline|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.
The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
521483|NCT00785772|P1|Participant Flow|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.
The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
521484|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.
The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
521485|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.
The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
521574|NCT00779259|O2|Outcome|4 Hours After Co-Administered Dose of Theophylline/Quinine|measured 4 hours after the 7 am co-administered dose of theophylline and quinine
521486|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.
The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
521487|NCT00785772|E1|Reported Event|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.
The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
521488|NCT00785785|B3|Baseline|Total|Total of all reporting groups
521489|NCT00785785|B2|Baseline|Nilotinib First, Then Imatinib|patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
521490|NCT00785785|B1|Baseline|Imatinib First, Then Nilotinib|patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
521491|NCT00785785|P2|Participant Flow|Nilotinib First, Then Imatinib|patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
521492|NCT00785785|P1|Participant Flow|Imatinib First, Then Nilotinib|patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
521493|NCT00785785|O2|Outcome|Imatinib|imatinib 400 mg once daily
521494|NCT00785785|O1|Outcome|Nilotinib|nilotinib 400 mg twice a day
521495|NCT00785785|E4|Reported Event|Crossover Imatinib|exposure to nilotinib and then imatinib
521496|NCT00785785|E3|Reported Event|Crossover Nilotinib|exposure to imatinib and then nilotinib
521497|NCT00785785|E2|Reported Event|Imatinib|Exposure to Imatinib only
521498|NCT00785785|E1|Reported Event|Nilotinib|Exposure to Nilotinib only
521499|NCT00785798|B1|Baseline|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle
Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle
Vorinostat : 200mg to 400 mg twice daily on days 1-7"
521500|NCT00785798|P1|Participant Flow|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle
Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle
Vorinostat : 200mg to 400 mg twice daily on days 1-7"
521501|NCT00785798|O1|Outcome|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle
Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle
Vorinostat : 200mg to 400 mg twice daily on days 1-7"
521502|NCT00785798|O1|Outcome|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle
Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle
Vorinostat : 200mg to 400 mg twice daily on days 1-7"
521503|NCT00785798|E1|Reported Event|Vorinostat Doxil|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle
Vorinostat: 200mg to 400 mg twice daily on days 1-7
Pegylated Liposomal Doxorubicin (PLD), Doxil: IV 30mg/m2 on day 3 of a 21-day cycle"
521504|NCT00785980|B1|Baseline|Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin|All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
521505|NCT00785980|P1|Participant Flow|Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin|All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
521506|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
521507|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
521508|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
521509|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
521510|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
521511|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
521512|NCT00785980|E3|Reported Event|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, all subjects received a dose of quinine sulfate (2 x 324 mg capsules) co-administered with a dose of ciprofloxacin (1 x 500 mg tablet) after an overnight fast of at least 10 hours.
521513|NCT00785980|E2|Reported Event|Ciprofloxacin Alone|Beginning on Day 8 in the morning and continuing through Day 11 in the evening, all subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice daily for a total of 8 doses.
521514|NCT00785980|E1|Reported Event|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period. On Day 11 in the morning, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) following an overnight fast of 10 hours.
521515|NCT00778999|B3|Baseline|Total|Total of all reporting groups
521516|NCT00778999|B2|Baseline|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
521517|NCT00778999|B1|Baseline|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
521518|NCT00778999|P2|Participant Flow|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
521519|NCT00778999|P1|Participant Flow|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
521520|NCT00778999|O2|Outcome|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
521521|NCT00778999|O1|Outcome|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
521522|NCT00778999|E2|Reported Event|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
521523|NCT00778999|E1|Reported Event|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
521524|NCT00779025|B1|Baseline|Overall Study (ITT)|The group evaluated was based on intention to treat (ITT).
521525|NCT00779025|P1|Participant Flow|Overall Study (ITT)|The group evaluated was based on intention to treat (ITT).
521526|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
521527|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
521528|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
521529|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
521530|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
521531|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
521532|NCT00779025|E1|Reported Event|Overall Study|
521533|NCT00779038|B1|Baseline|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
521534|NCT00779038|P1|Participant Flow|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
521535|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
521536|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
521537|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
521538|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
521539|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
521540|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
521541|NCT00779038|E1|Reported Event|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
521542|NCT00779116|B1|Baseline|Total Population|All randomized subjects
521543|NCT00779116|P2|Participant Flow|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine Reditab.
521544|NCT00779116|P1|Participant Flow|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet.
521545|NCT00779116|O3|Outcome|No Preference|All randomized subjects.
521546|NCT00779116|O2|Outcome|Zyrtec|All randomized subjects.
521547|NCT00779116|O1|Outcome|RediTab|All randomized subjects.
521548|NCT00779116|E2|Reported Event|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine Reditab (first and second intervention period).
521549|NCT00779116|E1|Reported Event|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
521550|NCT00779142|B1|Baseline|Methotrexate 25mg/ml|Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.
521551|NCT00779142|P1|Participant Flow|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.
Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
521552|NCT00779142|O1|Outcome|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.
Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
521553|NCT00779142|E1|Reported Event|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.
Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
521554|NCT00779155|B3|Baseline|Total|Total of all reporting groups
521555|NCT00779155|B2|Baseline|Active Resonator Device|Active pico-tesla magnetic fields
521556|NCT00779155|B1|Baseline|Inactive Resonator Device|inactive magnetic fields with placebo fields
521557|NCT00779155|P2|Participant Flow|Active Resonator Device|Active pico-tesla magnetic fields
521558|NCT00779155|P1|Participant Flow|Inactive Resonator Device|inactive magnetic fields with placebo fields
521559|NCT00779155|O2|Outcome|Active Resonator Device|Active pico-tesla magnetic fields
521560|NCT00779155|O1|Outcome|Inactive Resonator Device|inactive magnetic fields with placebo fields
521561|NCT00779155|E2|Reported Event|Active Resonator Device|Active pico-tesla magnetic fields
521562|NCT00779155|E1|Reported Event|Inactive Resonator Device|inactive magnetic fields with placebo fields
521563|NCT00779246|B3|Baseline|Total|Total of all reporting groups
521564|NCT00779246|B2|Baseline|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
521565|NCT00779246|B1|Baseline|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
521566|NCT00779246|P2|Participant Flow|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
521567|NCT00779246|P1|Participant Flow|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
521568|NCT00779246|O2|Outcome|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will be performed but results will be blinded and not used to determine need for contact isolation.
521569|NCT00779246|O1|Outcome|Active Surveillance Cultures (ASC)|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Patient will remain in contact isolation until results returned as negative.
521570|NCT00779246|E2|Reported Event|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
521571|NCT00779246|E1|Reported Event|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
521572|NCT00779259|B1|Baseline|Theophylline Alone, Quinine Alone, Theophylline With Quinine|This study was done in two cohorts, each receiving the same dosing regimen. For each cohort, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml concentration) at 7:00am on Day 1 following an overnight fast of at least 10 hours. After a 4-day washout period, subjects received 648 mg of quinine sulfate (2 x 324 mg capsules) every 8 hours (dosing occurred at 7am, 3pm and 11pm daily) starting with the 3pm dose on Day 5 and continuing through the morning dose on Day 12. Subjects also received a single 300 mg dose of theophylline along with their 648 mg quinine sulfate dose on the morning of Day 12.
521573|NCT00779259|P1|Participant Flow|Theophylline Alone, Quinine Alone, Theophylline With Quinine|This study was done in two cohorts, each receiving the same dosing regimen. For each cohort, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml concentration) at 7:00am on Day 1 following an overnight fast of at least 10 hours. After a 4-day washout period, subjects received 648 mg of quinine sulfate (2 x 324 mg capsules) every 8 hours (dosing occurred at 7am, 3pm and 11pm daily) starting with the 3pm dose on Day 5 and continuing through the morning dose on Day 12. Subjects also received a single 300 mg dose of theophylline along with their 648 mg quinine sulfate dose on the morning of Day 12.
521577|NCT00779259|O1|Outcome|1 Hour Before Morning Dose of Quinine on Study Day 11|measured 1 hour prior to the morning dose of Quinine on study Day 11
521578|NCT00779259|O2|Outcome|Theophylline in Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
521579|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml)followed by a 4 day washout period
521580|NCT00779259|O4|Outcome|Quinine in Presence of Theophylline|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
521581|NCT00779259|O3|Outcome|Theophylline in Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
521582|NCT00779259|O2|Outcome|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11
521583|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml)followed by a 4 day washout period
521584|NCT00779259|O4|Outcome|Quinine in the Presence of Theophylline|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration) and quinine sulfate (2 x 324 mg capsules).
521585|NCT00779259|O3|Outcome|Theophylline in the Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration) and quinine sulfate (2 x 324 mg capsules).
521586|NCT00779259|O2|Outcome|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11.
521587|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration)followed by a 4-day washout period.
521588|NCT00779259|E3|Reported Event|Theophylline Co-administered With Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml) and quinine sulfate (2 x 324 mg capsules).
521589|NCT00779259|E2|Reported Event|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11
521590|NCT00779259|E1|Reported Event|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml)followed by a 4 day washout period
521591|NCT00779285|B1|Baseline|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
521592|NCT00779285|P1|Participant Flow|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
521593|NCT00779285|O1|Outcome|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
521594|NCT00779285|E1|Reported Event|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
521595|NCT00779311|B6|Baseline|Total|Total of all reporting groups
521596|NCT00779311|B5|Baseline|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
521597|NCT00779311|B4|Baseline|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
521598|NCT00779311|B3|Baseline|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
521599|NCT00779311|B2|Baseline|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
521600|NCT00779311|B1|Baseline|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
521601|NCT00779311|P5|Participant Flow|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
521602|NCT00779311|P4|Participant Flow|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
521603|NCT00779311|P3|Participant Flow|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
521604|NCT00779311|P2|Participant Flow|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
521605|NCT00779311|P1|Participant Flow|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
521606|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
522398|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
521607|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
521608|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
521609|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
521610|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
521611|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
521612|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
521613|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
521614|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
521615|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
521616|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
521617|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
521618|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
521619|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
521620|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
521621|NCT00779311|E5|Reported Event|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
521622|NCT00779311|E4|Reported Event|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
521623|NCT00779311|E3|Reported Event|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
521624|NCT00779311|E2|Reported Event|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
521625|NCT00779311|E1|Reported Event|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
521626|NCT00779467|B5|Baseline|Total|Total of all reporting groups
521627|NCT00779467|B4|Baseline|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml"
521628|NCT00779467|B3|Baseline|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521629|NCT00779467|B2|Baseline|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521630|NCT00779467|B1|Baseline|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521631|NCT00779467|P4|Participant Flow|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml"
521632|NCT00779467|P3|Participant Flow|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521633|NCT00779467|P2|Participant Flow|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521634|NCT00779467|P1|Participant Flow|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521635|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml"
521974|NCT00793793|B11|Baseline|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
521636|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521637|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521638|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521639|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml"
521640|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521641|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521642|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521643|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml"
521644|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521645|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521646|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521647|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml"
521648|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521649|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521650|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521651|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml"
521652|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521653|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521654|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521655|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml"
521656|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521657|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521658|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521659|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml"
521660|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521661|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521662|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521663|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml"
521664|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521665|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521666|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521667|NCT00779467|E4|Reported Event|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml"
521668|NCT00779467|E3|Reported Event|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521669|NCT00779467|E2|Reported Event|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521670|NCT00779467|E1|Reported Event|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine"
521671|NCT00779506|B1|Baseline|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
521672|NCT00779506|P1|Participant Flow|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
521673|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
521674|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
521675|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
521676|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
521677|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
521678|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
521679|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
521680|NCT00779506|E1|Reported Event|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
521681|NCT00779558|B3|Baseline|Total|Total of all reporting groups
521682|NCT00779558|B2|Baseline|Placebo|Placebo - normal saline infusion
521683|NCT00779558|B1|Baseline|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour
Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
521684|NCT00779558|P2|Participant Flow|Placebo|Placebo - normal saline infusion
521685|NCT00779558|P1|Participant Flow|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour
Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
521686|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
521687|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour
Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
521688|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
521689|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour
Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
521690|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
521691|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour
Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
521692|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
521693|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour
Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
521694|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
521695|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour
Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
521696|NCT00779558|E2|Reported Event|Placebo|Placebo - normal saline infusion
521697|NCT00779558|E1|Reported Event|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour
Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
521698|NCT00779584|B10|Baseline|Total|Total of all reporting groups
521699|NCT00779584|B9|Baseline|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521700|NCT00779584|B8|Baseline|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521701|NCT00779584|B7|Baseline|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521702|NCT00779584|B6|Baseline|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521703|NCT00779584|B5|Baseline|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521704|NCT00779584|B4|Baseline|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521705|NCT00779584|B3|Baseline|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521706|NCT00779584|B2|Baseline|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521707|NCT00779584|B1|Baseline|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521708|NCT00779584|P9|Participant Flow|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521709|NCT00779584|P8|Participant Flow|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521710|NCT00779584|P7|Participant Flow|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521711|NCT00779584|P6|Participant Flow|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521712|NCT00779584|P5|Participant Flow|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521713|NCT00779584|P4|Participant Flow|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521714|NCT00779584|P3|Participant Flow|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521715|NCT00779584|P2|Participant Flow|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521716|NCT00779584|P1|Participant Flow|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an intravenous (IV) infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521717|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521718|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521719|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521720|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521721|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521722|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521723|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521817|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521724|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521725|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521726|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521727|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521728|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521729|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521730|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521731|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521732|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521733|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521734|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521735|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521736|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521737|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521738|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521739|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521740|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521741|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521742|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521743|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521744|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521745|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521746|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521747|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521748|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521749|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521750|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521751|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521752|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521753|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521754|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521755|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521756|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521757|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521758|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521759|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521760|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521761|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521762|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521763|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521764|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521765|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521766|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521767|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521768|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521769|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521770|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521771|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521772|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521773|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521774|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521775|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521776|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521777|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521778|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521779|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521780|NCT00779584|E9|Reported Event|MK-8776 200mg Flat Dose+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521781|NCT00779584|E8|Reported Event|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521782|NCT00779584|E7|Reported Event|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521783|NCT00779584|E6|Reported Event|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521784|NCT00779584|E5|Reported Event|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521785|NCT00779584|E4|Reported Event|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521786|NCT00779584|E3|Reported Event|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521787|NCT00779584|E2|Reported Event|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521788|NCT00779584|E1|Reported Event|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
521789|NCT00779675|B1|Baseline|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521790|NCT00779675|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521791|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521792|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521793|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521794|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521818|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
522343|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
521819|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
521795|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521796|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
521797|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
521798|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
521799|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
521800|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Week 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characterisitics (SPC; European Union), or local labelling (for all other countries).
521801|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2,6, and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labelling (for all other Countries)
521802|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labelling (for all other Countries).
521803|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521804|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521805|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521806|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521807|NCT00779675|E1|Reported Event|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
521808|NCT00779701|B1|Baseline|Insulin Infusion|"All subjects placed on insulin infusion.
Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
521809|NCT00779701|P1|Participant Flow|Insulin Infusion|"All subjects placed on insulin infusion.
Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
521810|NCT00779701|O1|Outcome|Insulin Infusion|"All subjects placed on insulin infusion.
Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
521811|NCT00779701|E1|Reported Event|Insulin Infusion|"All subjects placed on insulin infusion.
Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
521812|NCT00779766|B3|Baseline|Total|Total of all reporting groups
521813|NCT00779766|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521814|NCT00779766|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521815|NCT00779766|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521816|NCT00779766|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521820|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521821|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521822|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521823|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521824|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521825|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
521826|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
521827|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521828|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521829|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521830|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521831|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521832|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521833|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521834|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521835|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521836|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521837|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521838|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521839|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521840|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521841|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521842|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521843|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521844|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521845|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521846|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521847|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521848|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521849|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521931|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
521850|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521851|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521852|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521853|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521854|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521855|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521856|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521857|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521858|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521859|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521860|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521861|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521862|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521863|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521864|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521865|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521866|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521867|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521868|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521869|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521870|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521871|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521872|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521873|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521874|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521875|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521876|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521877|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521878|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521879|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521880|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521973|NCT00793793|B12|Baseline|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
521881|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521882|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521883|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521884|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521885|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521886|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521887|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521888|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521889|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521890|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521891|NCT00779766|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521892|NCT00779766|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
521893|NCT00779779|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
521894|NCT00779779|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
521895|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
521896|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
521897|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
521898|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
521899|NCT00779779|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
521900|NCT00779857|B1|Baseline|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
521901|NCT00779857|P1|Participant Flow|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
521902|NCT00779857|O1|Outcome|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
521903|NCT00779857|O1|Outcome|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
521904|NCT00779857|E1|Reported Event|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
521905|NCT00780273|B1|Baseline|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.
Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.
A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.
After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated."
521928|NCT00786188|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Interventions Administered:
Subjects received Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime.
Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime."
521929|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
530570|NCT00807885|B1|Baseline|Tegaderm-secured 24 ga Teflon Catheter|
521975|NCT00793793|B10|Baseline|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
521906|NCT00780273|P1|Participant Flow|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.
Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.
A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.
After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated."
521907|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.
Biomet 3i Prevail Implants"
521908|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.
Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
521909|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.
Biomet 3i Prevail Implants"
521910|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.
Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
521911|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.
Biomet 3i Prevail Implants"
521912|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.
Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
521913|NCT00780273|E1|Reported Event|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.
Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study."
521914|NCT00786032|B1|Baseline|BCI Device|"All participants will use the BCI System as a means of communication.
Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
521915|NCT00786032|P1|Participant Flow|BCI Device|"All participants will use the BCI System as a means of communication.
Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
521916|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.
Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
521917|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.
Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
521918|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.
Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
521919|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.
Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
521920|NCT00786032|O1|Outcome|BCI Device - Time Assisting Patient With Device|"All participants will use the BCI System as a means of communication.
Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles. The time was measured of how long the the caregiver assisted the patient with the device."
521921|NCT00786032|O1|Outcome|BCI Device|"The McGill Quality of Life (MQOL) is a 16 item scale that has five distinct sub-measures: physical well-being; physical symptoms; psychological symptoms; existential well-being; support. These sub-measures are averaged to give a MQOL total score.
The range of total score is from 0 (worst) to 10 (best)."
521922|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.
Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
521923|NCT00786032|E1|Reported Event|BCI Device|"All participants will use the BCI System as a means of communication.
Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
521924|NCT00786188|B3|Baseline|Total|Total of all reporting groups
521925|NCT00786188|B2|Baseline|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill.
521926|NCT00786188|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
521927|NCT00786188|P2|Participant Flow|Placebo - Sugar Pill|"Interventions Administered:
Subjects received placebo capsules administered once daily at bedtime.
Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive placebo administered once daily at bedtime."
521930|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Subjects will be randomized to one of the two treatments in a 1:1 ratio."
522392|NCT00793910|P2|Participant Flow|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
521932|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Subjects will be randomized to one of the two treatments in a 1:1 ratio."
521933|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
521934|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Subjects will be randomized to one of the two treatments in a 1:1 ratio."
521935|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
521936|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Subjects will be randomized to one of the two treatments in a 1:1 ratio."
521937|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
521938|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Subjects will be randomized to one of the two treatments in a 1:1 ratio."
521939|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
521940|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Subjects will be randomized to one of the two treatments in a 1:1 ratio."
521941|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
521942|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Subjects will be randomized to one of the two treatments in a 1:1 ratio."
521943|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
521944|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Subjects will be randomized to one of the two treatments in a 1:1 ratio."
521945|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
521946|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Subjects will be randomized to one of the two treatments in a 1:1 ratio."
521947|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
521948|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
521949|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
521950|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg capsules.
Subjects will be randomized to one of the two treatments in a 1:1 ratio"
521951|NCT00786188|E2|Reported Event|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill.
521952|NCT00786188|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
521953|NCT00793780|B3|Baseline|Total|Total of all reporting groups
521954|NCT00793780|B2|Baseline|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
521955|NCT00793780|B1|Baseline|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
521956|NCT00793780|P2|Participant Flow|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
521957|NCT00793780|P1|Participant Flow|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
521958|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
521959|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
521960|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
521961|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
521962|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
521963|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
521964|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
521965|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
521966|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
521967|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
521968|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
521969|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
521970|NCT00793780|E2|Reported Event|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
521971|NCT00793780|E1|Reported Event|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
521972|NCT00793793|B13|Baseline|Total|Total of all reporting groups
522393|NCT00793910|P1|Participant Flow|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
521976|NCT00793793|B9|Baseline|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
521977|NCT00793793|B8|Baseline|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
521978|NCT00793793|B7|Baseline|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
521979|NCT00793793|B6|Baseline|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
521980|NCT00793793|B5|Baseline|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
521981|NCT00793793|B4|Baseline|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
521982|NCT00793793|B3|Baseline|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
521983|NCT00793793|B2|Baseline|TN: 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
521984|NCT00793793|B1|Baseline|Treatment Naive (TN): Placebo|TN patient to receive Placebo + PegIFN/RBV for 28 days
521985|NCT00793793|P12|Participant Flow|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
521986|NCT00793793|P11|Participant Flow|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
521987|NCT00793793|P10|Participant Flow|TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
521988|NCT00793793|P9|Participant Flow|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
521989|NCT00793793|P8|Participant Flow|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
521990|NCT00793793|P7|Participant Flow|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
521991|NCT00793793|P6|Participant Flow|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
521992|NCT00793793|P5|Participant Flow|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
521993|NCT00793793|P4|Participant Flow|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
521994|NCT00793793|P3|Participant Flow|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
521995|NCT00793793|P2|Participant Flow|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
521996|NCT00793793|P1|Participant Flow|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
521997|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
521998|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
521999|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522000|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522001|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522002|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522003|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522004|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522005|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522006|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522007|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
522008|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522009|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522010|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522011|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522012|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522013|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522014|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522015|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522016|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522017|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522018|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
522019|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522020|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522021|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522022|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522023|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522024|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522025|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522026|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522027|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522028|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522029|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522030|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522031|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522032|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522033|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522034|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522035|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522036|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522037|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522038|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522039|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522040|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522041|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522042|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522043|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522044|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522045|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522046|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522047|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522048|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522049|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522050|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522051|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522052|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522053|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522054|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522055|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522056|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522057|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522058|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522059|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522060|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522061|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522062|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522063|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522064|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522065|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522066|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522067|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522068|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522069|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522070|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522071|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522072|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522073|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522074|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522075|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522076|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522077|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522078|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522079|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522080|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522081|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522082|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522083|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522084|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522085|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522086|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522087|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522088|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522089|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522090|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522091|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522092|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522093|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522094|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522095|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522096|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522097|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522098|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522099|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522100|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522101|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522102|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522103|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522104|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522105|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522106|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522107|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522108|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522109|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522110|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522111|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522394|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
522112|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522113|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522114|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522115|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522116|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522117|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522118|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522119|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522120|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522121|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522122|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522123|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522124|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522125|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522126|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522127|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522128|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522129|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522130|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522131|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522132|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522133|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522134|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522135|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522136|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522137|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522138|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522139|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522140|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522141|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522142|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522143|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522144|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522145|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522146|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522147|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522148|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522149|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522150|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522151|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522152|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522153|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522154|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522155|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522156|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522157|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522204|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522158|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522159|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522160|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522161|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522162|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522163|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
522164|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522165|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522166|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522167|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522168|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522169|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522170|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE patient non-cirrhotic to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522171|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522172|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522173|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522174|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522175|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
522176|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522177|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522178|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522179|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522180|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522181|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522182|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522183|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522184|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522185|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522186|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
522187|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
522188|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522189|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522190|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522191|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522192|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522193|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522194|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522195|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522196|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522197|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522198|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
522199|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
522200|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522201|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522202|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522203|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522205|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522206|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522207|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522208|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522209|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522210|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
522211|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
522212|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522213|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522214|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522215|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522216|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522217|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522218|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522219|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522220|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522221|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522222|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522223|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
522224|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522225|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522226|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522227|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522228|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522229|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522230|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522231|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522232|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522233|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522234|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522235|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
522236|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522237|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522238|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522239|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522240|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522241|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522242|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522243|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522244|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522245|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522246|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
522247|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
522248|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522249|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522250|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522251|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522252|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522253|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522254|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522255|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522256|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522257|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522258|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
522259|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
522260|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522261|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522262|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522263|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522264|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522265|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522266|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522267|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522268|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522269|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522270|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522271|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
522272|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522273|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522274|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522275|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522276|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522277|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522278|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522279|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522280|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522281|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522282|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522283|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
522284|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522285|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522286|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522287|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522288|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522289|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522290|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522291|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522292|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522293|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522294|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
522295|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
522296|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522297|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522298|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522299|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522300|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522301|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522302|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522303|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522304|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522305|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522306|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522307|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
522308|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522309|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522310|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522311|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522312|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522313|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522314|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522315|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522316|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522317|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522318|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522319|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
522320|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522321|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522322|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522323|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522324|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522325|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522326|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522327|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522328|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522329|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522330|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522331|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
522332|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522333|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522334|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522335|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522336|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522337|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522338|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522339|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522340|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522341|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522342|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522344|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522345|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522346|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522347|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522348|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522349|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522350|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522351|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522352|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522353|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522354|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522355|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
522356|NCT00793793|E12|Reported Event|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522357|NCT00793793|E11|Reported Event|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522358|NCT00793793|E10|Reported Event|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522359|NCT00793793|E9|Reported Event|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
522360|NCT00793793|E8|Reported Event|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522361|NCT00793793|E7|Reported Event|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522362|NCT00793793|E6|Reported Event|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
522363|NCT00793793|E5|Reported Event|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522364|NCT00793793|E4|Reported Event|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522365|NCT00793793|E3|Reported Event|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
522366|NCT00793793|E2|Reported Event|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
522367|NCT00793793|E1|Reported Event|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
522368|NCT00793819|B3|Baseline|Total|Total of all reporting groups
522369|NCT00793819|B2|Baseline|Placebo|1 placebo capsule daily
522370|NCT00793819|B1|Baseline|Silodosin 8mg|Silodosin 8mg daily
522371|NCT00793819|P2|Participant Flow|Placebo|1 placebo capsule daily
522372|NCT00793819|P1|Participant Flow|Silodosin 8mg|Silodosin 8mg daily
522373|NCT00793819|O2|Outcome|Placebo|1 placebo capsule daily
522374|NCT00793819|O1|Outcome|Silodosin 8mg|Silodosin 8mg daily
522375|NCT00793819|E2|Reported Event|Placebo|1 placebo capsule daily
522376|NCT00793819|E1|Reported Event|Silodosin 8mg|Silodosin 8mg daily
522377|NCT00793871|B1|Baseline|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522378|NCT00793871|P1|Participant Flow|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 milligram (mg) orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522379|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522395|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
522396|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
522399|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
522400|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
522380|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522381|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522382|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522383|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522384|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522385|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522386|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522387|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522388|NCT00793871|E1|Reported Event|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
522389|NCT00793910|B3|Baseline|Total|Total of all reporting groups
522390|NCT00793910|B2|Baseline|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
522391|NCT00793910|B1|Baseline|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
522401|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
522402|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
522403|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
522404|NCT00793910|E2|Reported Event|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
522405|NCT00793910|E1|Reported Event|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
522406|NCT00794118|B1|Baseline|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522407|NCT00794118|P1|Participant Flow|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522408|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522409|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522410|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522411|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522412|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522413|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522414|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522415|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522416|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522417|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522418|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522419|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522420|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522421|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522422|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522423|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522424|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522425|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522426|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522427|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522428|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522429|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522504|NCT00794170|E1|Reported Event|Telephone and Print Based Intervention|
522505|NCT00794196|B3|Baseline|Total|Total of all reporting groups
522430|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522431|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522432|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522433|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522434|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522435|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522436|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522437|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522438|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522439|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522440|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522441|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522442|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522443|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522444|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522445|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522446|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522447|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522448|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522449|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522450|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522451|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522452|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522453|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522454|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522455|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522456|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522532|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
522457|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522458|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522459|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522460|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522461|NCT00794118|E1|Reported Event|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
522462|NCT00794144|B3|Baseline|Total|Total of all reporting groups
522463|NCT00794144|B2|Baseline|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
522464|NCT00794144|B1|Baseline|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
522465|NCT00794144|P2|Participant Flow|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
522466|NCT00794144|P1|Participant Flow|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
522467|NCT00794144|O2|Outcome|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
522468|NCT00794144|O1|Outcome|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
522469|NCT00794144|E2|Reported Event|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
522470|NCT00794144|E1|Reported Event|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
522471|NCT00794157|B4|Baseline|Total|Total of all reporting groups
522472|NCT00794157|B3|Baseline|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522473|NCT00794157|B2|Baseline|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522474|NCT00794157|B1|Baseline|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522475|NCT00794157|P3|Participant Flow|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522476|NCT00794157|P2|Participant Flow|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522477|NCT00794157|P1|Participant Flow|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522478|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522479|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522480|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522481|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522482|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522483|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522577|NCT00794664|B1|Baseline|Placebo|Weekly subcutaneous injections for 26 weeks
522533|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
522484|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522485|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522486|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522487|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522488|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522489|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522490|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522491|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522492|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522493|NCT00794157|E3|Reported Event|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522494|NCT00794157|E2|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522495|NCT00794157|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
522496|NCT00794170|B3|Baseline|Total|Total of all reporting groups
522497|NCT00794170|B2|Baseline|Usual Care|control
522498|NCT00794170|B1|Baseline|Telephone and Print Based Intervention|This was a tailored phone call followed up by print materials.
522499|NCT00794170|P2|Participant Flow|Usual Care|The control group receives usual care at each clinical site and interacts with study personnel only for data collection.
522500|NCT00794170|P1|Participant Flow|Telephone and Print Based Intervention|The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.
522501|NCT00794170|O2|Outcome|Usual Care|The control group receives usual care at each clinical site and interacts with study personnel only for data collection. Both groups receive birthday cards from the study team.
522502|NCT00794170|O1|Outcome|Telephone and Print Intervention|The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.
522503|NCT00794170|E2|Reported Event|Usual Care|
522506|NCT00794196|B2|Baseline|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.
Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
522507|NCT00794196|B1|Baseline|Usual Care|The control group will be receiving usual medical and pharmaceutical care.
522508|NCT00794196|P2|Participant Flow|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.
Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
522509|NCT00794196|P1|Participant Flow|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
522510|NCT00794196|O2|Outcome|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
522511|NCT00794196|O1|Outcome|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.
Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
522512|NCT00794196|O2|Outcome|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
522513|NCT00794196|O1|Outcome|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.
Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
522514|NCT00794196|E2|Reported Event|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.
Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
522515|NCT00794196|E1|Reported Event|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
522516|NCT00794313|B1|Baseline|All Study Participants|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks or Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week or Sugar Pill : sugar pill, capsule, three times a day, 2 weeks"
522517|NCT00794313|P3|Participant Flow|Placebo, Then Amantadine, Then Amantadine + Topiramate|Placebo: Sugar pill 2 capsule three times a day, 2 weeks then 7 Days washout then Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2) then 7 Days washout then Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2)
522518|NCT00794313|P2|Participant Flow|Amantadine + Topiramate, Then Placebo, Then Amantadine|Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2) then 7 Days washout then Placebo: Sugar pill 2 capsule three times a day, 2 weeks then 7 Days washout then Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2)
522519|NCT00794313|P1|Participant Flow|Amantadine, Then Amantadine + Topiramate, Then Placebo|Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2) then 7 Days washout then Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2) then 7 Days washout then Placebo: Sugar pill 2 capsule three times a day, 2 weeks
522520|NCT00794313|O3|Outcome|Sugar Pill|Sugar Pill: sugar pill, capsule, three times a day, 2 weeks
522521|NCT00794313|O2|Outcome|Amantadine Plus Topiramate|"Amantadine 300 mg: Amantadine, 300 mg, capsule, three times a day, two weeks
Topiramate: Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
522522|NCT00794313|O1|Outcome|Amantadine|Amantadine 300 mg: Amantadine, 300 mg, capsule, three times a day, two weeks
522523|NCT00794313|O3|Outcome|Sugar Pill|Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
522524|NCT00794313|O2|Outcome|Amantadine Plus Topiramate|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
522525|NCT00794313|O1|Outcome|Amantadine|Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
522526|NCT00794313|E3|Reported Event|Sugar Pill|Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
522527|NCT00794313|E2|Reported Event|Amantadine Plus Topiramate|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
522528|NCT00794313|E1|Reported Event|Amantadine|Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
522529|NCT00794365|B1|Baseline|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
522530|NCT00794365|P1|Participant Flow|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
522531|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
522578|NCT00794664|P2|Participant Flow|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522534|NCT00794365|E1|Reported Event|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
522535|NCT00794469|B1|Baseline|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
522536|NCT00794469|P1|Participant Flow|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
522537|NCT00794469|O1|Outcome|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
522538|NCT00794469|O1|Outcome|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
522539|NCT00794469|E1|Reported Event|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
522540|NCT00794508|B1|Baseline|Experimental Retroviral-mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
522541|NCT00794508|P1|Participant Flow|Gamma-retroviral-mediated ADA Gene Transfer|"Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow.
ADA gene transfer: Autologous CD34+ cells transduced with the gamma-retroviral vector, MND-ADA, carrying the human ADA gene."
522542|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
522543|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
522544|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
522545|NCT00794508|E1|Reported Event|Retroviral-mediated ADA Gene Transfer|"Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow.
ADA gene transfer: Autologous CD34+ cells transduced with the retroviral vector MND-ADA, carrying the human ADA gene."
522546|NCT00794547|B1|Baseline|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
522547|NCT00794547|P2|Participant Flow|Phase 2|"In the Phase II part of the study, we will find out the response of subjects' cancer has to the combination of a fixed dose of calcitriol (determined in the phase I study) with standard chemotherapy.
Calcitriol: In this portion of the study, all patients will get the same dose of calcitriol (determined from the Phase I study) along with the standard chemotherapy"
522548|NCT00794547|P1|Participant Flow|Phase 1|"In the Phase I part of the study, we will test the safety of calcitriol along with standard chemotherapy. In addition, the goal is to see what effects (good and bad) it has on you and your type of Non-Small Cell Lung Cancer. This study is ongoing. In this portion of the study, we are testing increasing doses of calcitriol in combination with standard chemotherapy. If 2/3 patients at any dose level experience side effects that are limiting, we will call the dose level below that dose the maximum tolerated dose.
Calcitriol: Escalating dose of Calcitriol will be infused IV over 1 hour every 21 days."
522549|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
522550|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
522551|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
522552|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
522553|NCT00794547|E1|Reported Event|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
522554|NCT00794560|B5|Baseline|Total|Total of all reporting groups
522555|NCT00794560|B4|Baseline|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
522556|NCT00794560|B3|Baseline|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
patient education: Possible, individualized interventions:
Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
First self-injection under control of a specially trained pharmacist"
522557|NCT00794560|B2|Baseline|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
522558|NCT00794560|B1|Baseline|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.
patient education: Possible, individualized interventions:
Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
First self-injection under control of a specially trained pharmacist"
522559|NCT00794560|P4|Participant Flow|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
522579|NCT00794664|P1|Participant Flow|Placebo|Weekly subcutaneous injections for 26 weeks
530571|NCT00807885|P9|Participant Flow|SC Button With 27 ga X 9 mm Needle|
522580|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522581|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522560|NCT00794560|P3|Participant Flow|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
patient education: Possible, individualized interventions:
Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
First self-injection under control of a specially trained pharmacist"
522561|NCT00794560|P2|Participant Flow|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
522562|NCT00794560|P1|Participant Flow|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.
patient education: Possible, individualized interventions:
Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
First self-injection under control of a specially trained pharmacist"
522563|NCT00794560|O4|Outcome|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
522564|NCT00794560|O3|Outcome|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
patient education: Possible, individualized interventions:
Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
First self-injection under control of a specially trained pharmacist"
522565|NCT00794560|O2|Outcome|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
522566|NCT00794560|O1|Outcome|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.
patient education: Possible, individualized interventions:
Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
First self-injection under control of a specially trained pharmacist"
522567|NCT00794560|O4|Outcome|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
522568|NCT00794560|O3|Outcome|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
patient education: Possible, individualized interventions:
Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
First self-injection under control of a specially trained pharmacist"
522569|NCT00794560|O2|Outcome|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
522570|NCT00794560|O1|Outcome|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.
patient education: Possible, individualized interventions:
Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
First self-injection under control of a specially trained pharmacist"
522571|NCT00794560|E4|Reported Event|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
522572|NCT00794560|E3|Reported Event|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
patient education: Possible, individualized interventions:
Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
First self-injection under control of a specially trained pharmacist"
522573|NCT00794560|E2|Reported Event|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
522574|NCT00794560|E1|Reported Event|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.
patient education: Possible, individualized interventions:
Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
First self-injection under control of a specially trained pharmacist"
522575|NCT00794664|B3|Baseline|Total|Total of all reporting groups
522576|NCT00794664|B2|Baseline|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522582|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522583|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522584|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522585|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522586|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522587|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522588|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522589|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522590|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522591|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522592|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522593|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522594|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522595|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522596|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522597|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522598|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522599|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522600|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522601|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522602|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522603|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522604|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522605|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522606|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522607|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522608|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522609|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522610|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522611|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522612|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522613|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522614|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522615|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522616|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522617|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522618|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522619|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
522620|NCT00794664|E2|Reported Event|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
522621|NCT00794664|E1|Reported Event|Placebo|Weekly subcutaneous injections for 26 weeks
522622|NCT00794677|B3|Baseline|Total|Total of all reporting groups
522623|NCT00794677|B2|Baseline|Placebo|Placebo once daily received as the first or second intervention
522624|NCT00794677|B1|Baseline|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
522625|NCT00794677|P2|Participant Flow|Placebo|Placebo once daily received as the first or second intervention
522626|NCT00794677|P1|Participant Flow|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
522627|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
522628|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
522629|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
522630|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
522631|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
522632|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
522633|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
522634|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
522635|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
522636|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
522637|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
522638|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
522639|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
522640|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
522641|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
522642|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
522643|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
522644|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
522743|NCT00795184|O6|Outcome|HDWLE+NBI|
522682|NCT00795132|O2|Outcome|Unrelated BM PBSC|All participants were analyzed.
522683|NCT00795132|O1|Outcome|Related BM PBSC|All participants were analyzed.
522645|NCT00794820|B1|Baseline|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
522646|NCT00794820|P1|Participant Flow|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
522647|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
522648|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
522649|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
522650|NCT00794820|E1|Reported Event|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
522651|NCT00794924|B3|Baseline|Total|Total of all reporting groups
522652|NCT00794924|B2|Baseline|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
522653|NCT00794924|B1|Baseline|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
522654|NCT00794924|P2|Participant Flow|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
522655|NCT00794924|P1|Participant Flow|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
522656|NCT00794924|O2|Outcome|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
522657|NCT00794924|O1|Outcome|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
522658|NCT00794963|B3|Baseline|Total|Total of all reporting groups
522659|NCT00794963|B2|Baseline|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
522660|NCT00794963|B1|Baseline|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
522661|NCT00794963|P2|Participant Flow|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
522662|NCT00794963|P1|Participant Flow|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
522663|NCT00794963|O2|Outcome|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
522664|NCT00794963|O1|Outcome|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
522665|NCT00794963|E2|Reported Event|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
522666|NCT00794963|E1|Reported Event|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
522667|NCT00795002|B3|Baseline|Total|Total of all reporting groups
522668|NCT00795002|B2|Baseline|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
522669|NCT00795002|B1|Baseline|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
522670|NCT00795002|P2|Participant Flow|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
522671|NCT00795002|P1|Participant Flow|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
522672|NCT00795002|O2|Outcome|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
522673|NCT00795002|O1|Outcome|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
522674|NCT00795002|E2|Reported Event|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
522675|NCT00795002|E1|Reported Event|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
522676|NCT00795132|B1|Baseline|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
522677|NCT00795132|P1|Participant Flow|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
522678|NCT00795132|O3|Outcome|Unrelated Cord Blood|All incidences of enrolled patients were analyzed.
522679|NCT00795132|O2|Outcome|Unrelated BM PBSC|All incidences of enrolled patients were analyzed.
522680|NCT00795132|O1|Outcome|Related BM PBSC|All incidences of enrolled patients were analyzed.
522681|NCT00795132|O3|Outcome|Unrelated Cord Blood|All participants were analyzed.
522744|NCT00795184|O5|Outcome|HDWLE+pCLE|
522684|NCT00795132|O3|Outcome|Unrelated Cord Blood|Unrelated donor: Cord Blood
522685|NCT00795132|O2|Outcome|Unrelated BM PBSC|Unrelated donor: bone marrow or peripheral blood stem cell (PBSC)
522686|NCT00795132|O1|Outcome|Related BM PBSC|Related donor: bone marrow or peripheral blood stem cell (PBSC)
522687|NCT00795132|E1|Reported Event|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
522688|NCT00795145|B3|Baseline|Total|Total of all reporting groups
522689|NCT00795145|B2|Baseline|Cohort 2: Placebo, Linezolid 600 mg and 1200 mg, Moxifloxacin|Subjects were randomly assigned to placebo first then moxifloxacin followed by linezolid 600 mg and 1200 mg linezolid last in Sequence 1; or linezolid 600 mg first then linezolid 1200 mg followed by placebo and moxifloxacin last in Sequence 2; or, linezolid 1200 mg first then moxifloxacin 400 mg followed by linezolid 600 mg and placebo last in Sequence 3; or, moxifloxacin 400 mg first then placebo followed by linezolid 1200 mg and 600 mg linezolid last in Sequence 4. There was a washout period of 48 hours between each dose.
522690|NCT00795145|B1|Baseline|Cohort 1: Placebo, Linezolid 900 mg and 1200 mg|Subjects were randomly assigned to placebo followed by linezolid 900 mg then 1200 mg linezolid in Sequence 1; or, linezolid 900 mg then linezolid 1200 mg followed by placebo in Sequence 2; or, linezolid 900 mg then placebo followed by linezolid 1200 mg in Sequence 3. There was a washout period of 48 hours between doses.
522691|NCT00795145|P7|Participant Flow|Cohort 2: Sequence 4|Subjects were randomly assigned to moxifloxacin 400 mg first, then placebo followed by linezolid 1200 mg and 600 mg linezolid after a washout period of 48 hours between doses in Sequence 4.
522692|NCT00795145|P6|Participant Flow|Cohort 2: Sequence 3|Subjects were randomly assigned to linezolid 1200 mg first, then moxifloxacin 400 mg followed by linezolid 600 mg and placebo after a washout period of 48 hours between doses in Sequence 3.
522693|NCT00795145|P5|Participant Flow|Cohort 2: Sequence 2|Subjects were randomly assigned to linezolid 600 mg first, then linezolid 1200 mg followed by placebo and moxifloxacin, after a washout period of 48 hours between doses in Sequence 2.
522694|NCT00795145|P4|Participant Flow|Cohort 2: Sequence 1|Subjects were randomly assigned to placebo, then moxifloxacin, followed by linezolid 600 mg and 1200 mg, after a washout period of 48 hours between doses in Sequence 1.
522695|NCT00795145|P3|Participant Flow|Cohort 1: Sequence 3|Subjects were randomly assigned to linezolid 900 mg first, then 1200 mg linezolid, followed by placebo after a washout period of 48 hours between doses in Sequence 3.
522696|NCT00795145|P2|Participant Flow|Cohort 1: Sequence 2|Subjects were randomly assigned to linezolid 900 mg first, then placebo, followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 2.
522697|NCT00795145|P1|Participant Flow|Cohort 1: Sequence 1|Subjects were randomly assigned to placebo first, then linezolid 900 milligrams (mg) followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 1.
522698|NCT00795145|O4|Outcome|Moxifloxacin 400 mg|
522699|NCT00795145|O3|Outcome|Cohort 2: Placebo|
522700|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
522701|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
522702|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
522703|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
522704|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
522705|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
522706|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
522707|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
522708|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
522709|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
522710|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
522711|NCT00795145|O1|Outcome|Cohort 2: 900 mg Linezolid|
522712|NCT00795145|O3|Outcome|Cohort 2: 1200 mg Linezolid|
522713|NCT00795145|O2|Outcome|Cohort 2: 600 mg Linezolid|
522714|NCT00795145|O1|Outcome|Cohort 2: Placebo|
522715|NCT00795145|O2|Outcome|Cohort 2: Placebo|
522716|NCT00795145|O1|Outcome|Cohort 2: Moxifloxacin|Oral administration, positive control, not blinded.
522717|NCT00795145|O3|Outcome|Cohort 2: Placebo|0.9% Saline
522718|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|Zyvox IV Injection
522719|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|Zyvox IV Injection
522720|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
522721|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
522722|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
522723|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
522724|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
522725|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
522726|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
522727|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
522728|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
522729|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
522730|NCT00795145|O3|Outcome|Cohort 1: 1200 mg Linezolid|600 mL Zyvox as a constant rate IV infusion of 60 minutes.
522731|NCT00795145|O2|Outcome|Cohort 1: 900 mg Linezolid|450 mL Zyvox plus 150 mL saline as a constant rate IV infusion of 60 minutes.
522732|NCT00795145|O1|Outcome|Cohort 1: Placebo|600 milliliters (mL) saline as a constant rate intravenous (IV) infusion of 60 minutes.
522733|NCT00795145|E7|Reported Event|Cohort 2: 400 mg Moxifloxacin|
522734|NCT00795145|E6|Reported Event|Cohort 2: 1200 mg Linezolid|
522735|NCT00795145|E5|Reported Event|Cohort 2: 600 mg Linezolid|
522736|NCT00795145|E4|Reported Event|Cohort 2: Placebo|
522737|NCT00795145|E3|Reported Event|Cohort 1: 1200 mg Linezolid|
522738|NCT00795145|E2|Reported Event|Cohort 1: 900 mg Linezolid|
522739|NCT00795145|E1|Reported Event|Cohort 1: Placebo|
522740|NCT00795184|B1|Baseline|Group 1|NBI-pCLE
522741|NCT00795184|P2|Participant Flow|NBI First HDWLE Second and pCLE|
522742|NCT00795184|P1|Participant Flow|HDWLE First NBI Second and pCLE|
522751|NCT00795210|B3|Baseline|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
522752|NCT00795210|B2|Baseline|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
522753|NCT00795210|B1|Baseline|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
522754|NCT00795210|P3|Participant Flow|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
522755|NCT00795210|P2|Participant Flow|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
522756|NCT00795210|P1|Participant Flow|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
522757|NCT00795210|O3|Outcome|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
522758|NCT00795210|O2|Outcome|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
522759|NCT00795210|O1|Outcome|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
522760|NCT00795210|O3|Outcome|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
522761|NCT00795210|O2|Outcome|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
522762|NCT00795210|O1|Outcome|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
522763|NCT00795210|E3|Reported Event|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
522764|NCT00795210|E2|Reported Event|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
522765|NCT00795210|E1|Reported Event|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
522766|NCT00795288|B3|Baseline|Total|Total of all reporting groups
522767|NCT00795288|B2|Baseline|Control|placebo: Control group
522768|NCT00795288|B1|Baseline|Simvastatin|"Simvastatin, 80 mg/day
Simvastatin, 80 mg/day for 21 days: Active treatment group"
522769|NCT00795288|P2|Participant Flow|Simvastatin|All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
522770|NCT00795288|P1|Participant Flow|Placebo|All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
522771|NCT00795288|O2|Outcome|Placebo|"Placebo
placebo: Control group"
522772|NCT00795288|O1|Outcome|Simvastatin, 80 mg/Day|"Simvastatin, 80 mg/day for 21 days
Simvastatin, 80 mg/day for 21 days: Active treatment group"
522773|NCT00795288|O2|Outcome|Control|placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
522774|NCT00795288|O1|Outcome|Simvastatin|Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
522775|NCT00795288|O2|Outcome|Control|placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
522776|NCT00795288|O1|Outcome|Simvastatin|Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
522777|NCT00795288|E2|Reported Event|Control|placebo: Control group
522778|NCT00795288|E1|Reported Event|Simvastatin|"Simvastatin, 80 mg/day
Simvastatin, 80 mg/day for 21 days: Active treatment group"
522779|NCT00795340|B3|Baseline|Total|Total of all reporting groups
522780|NCT00795340|B2|Baseline|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
carboplatin: Given IV
paclitaxel: Given IV
placebo: Given orally"
522781|NCT00795340|B1|Baseline|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
carboplatin: Given IV
cediranib maleate: Given orally
paclitaxel: Given IV"
522782|NCT00795340|P2|Participant Flow|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
carboplatin: Given IV
paclitaxel: Given IV
placebo: Given orally"
522783|NCT00795340|P1|Participant Flow|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
carboplatin: Given IV
cediranib maleate: Given orally
paclitaxel: Given IV"
522784|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
carboplatin: Given IV
paclitaxel: Given IV
placebo: Given orally"
522785|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
carboplatin: Given IV
cediranib maleate: Given orally
paclitaxel: Given IV"
522786|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
carboplatin: Given IV
paclitaxel: Given IV
placebo: Given orally"
522787|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
carboplatin: Given IV
cediranib maleate: Given orally
paclitaxel: Given IV"
522788|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
carboplatin: Given IV
paclitaxel: Given IV
placebo: Given orally"
522789|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
carboplatin: Given IV
cediranib maleate: Given orally
paclitaxel: Given IV"
522790|NCT00795340|E2|Reported Event|Placebo|Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
523443|NCT00797277|O1|Outcome|1. IM Olanzapine|10 mg olanzapine IM injection
522791|NCT00795340|E1|Reported Event|Cediranib|Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
522793|NCT00795366|B2|Baseline|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
522794|NCT00795366|B1|Baseline|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
522795|NCT00795366|P2|Participant Flow|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
522796|NCT00795366|P1|Participant Flow|AVP, Arginine Vasopressin|Vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
522797|NCT00795366|O2|Outcome|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
522798|NCT00795366|O1|Outcome|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
522799|NCT00795366|E2|Reported Event|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
522800|NCT00795366|E1|Reported Event|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
522801|NCT00795509|B1|Baseline|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
522802|NCT00795509|P1|Participant Flow|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
522803|NCT00795509|O1|Outcome|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
522804|NCT00795509|O1|Outcome|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
522805|NCT00795509|E1|Reported Event|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
522806|NCT00795535|B1|Baseline|Trauma Patients|Patients transported to the trauma center by helicopter
522807|NCT00795535|P1|Participant Flow|Trauma Patients|Patients transported to the trauma center by helicopter
522808|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
522809|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
522810|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
522811|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
522812|NCT00795535|E1|Reported Event|Trauma Patients|Patients transported to the trauma center by helicopter
522813|NCT00795600|B3|Baseline|Total|Total of all reporting groups
522814|NCT00795600|B2|Baseline|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522815|NCT00795600|B1|Baseline|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522816|NCT00795600|P2|Participant Flow|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522817|NCT00795600|P1|Participant Flow|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522818|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522819|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522820|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522821|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522822|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522823|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522824|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522825|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522826|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522827|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522828|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522829|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522830|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522831|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522832|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522833|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522989|NCT00795951|O1|Outcome|Irritation|Number of subjects who presented with irritation at patch removal
522834|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522835|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522836|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522837|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522838|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522839|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522840|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522841|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522842|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522843|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522844|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522845|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522846|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522847|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522848|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522849|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522850|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522851|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522852|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522853|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522854|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522855|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522856|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522857|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522858|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522859|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522860|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522861|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522862|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522863|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522864|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522865|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522866|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
523700|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
522867|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522868|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522869|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522870|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522871|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522872|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522873|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522874|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522875|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522876|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522877|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522878|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522879|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522880|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522881|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522882|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522883|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522884|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522885|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522886|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522887|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522888|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522889|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522890|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522891|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522892|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522893|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522894|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522895|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522896|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522897|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522898|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522899|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522900|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
523701|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
522901|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522902|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522903|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522904|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522905|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522906|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522907|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522908|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522909|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522910|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522911|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522912|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522913|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522914|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522915|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522916|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522917|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522918|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522919|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522920|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522921|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522922|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522923|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522924|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522925|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522926|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522927|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522928|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522929|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522930|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522931|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522932|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522933|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522934|NCT00795600|E2|Reported Event|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
523702|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
522988|NCT00795951|O1|Outcome|Adhesion|Number of subjects who presented with poor adhesion at patch removal
522935|NCT00795600|E1|Reported Event|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
522936|NCT00795639|B3|Baseline|Total|Total of all reporting groups
522937|NCT00795639|B2|Baseline|Placebo|Matching placebo tablet once a day
522938|NCT00795639|B1|Baseline|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
522939|NCT00795639|P2|Participant Flow|Placebo|Matching placebo tablet once a day
522940|NCT00795639|P1|Participant Flow|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
522941|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
522942|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
522943|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
522944|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
522945|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
522946|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
522947|NCT00795639|E2|Reported Event|Placebo|Matching placebo tablet once a day
522948|NCT00795639|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
522949|NCT00795704|B3|Baseline|Total|Total of all reporting groups
522950|NCT00795704|B2|Baseline|Mulberry Leaf Extract|500 mg #2 capsules three times daily
522951|NCT00795704|B1|Baseline|Placebo|Control Group
522952|NCT00795704|P2|Participant Flow|Mulberry Leaf Extract|500 mg #2 capsules three times daily
522953|NCT00795704|P1|Participant Flow|Placebo|Control Group
522954|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
522955|NCT00795704|O1|Outcome|Placebo|Control Group
522956|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
522957|NCT00795704|O1|Outcome|Placebo|Control Group
522958|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
522959|NCT00795704|O1|Outcome|Placebo|Control Group
522960|NCT00795704|E2|Reported Event|Mulberry Leaf Extract|500 mg #2 capsules three times daily
522961|NCT00795704|E1|Reported Event|Placebo|Control Group
522962|NCT00795717|B3|Baseline|Total|Total of all reporting groups
522963|NCT00795717|B2|Baseline|Placebo Then Lovaza|"Placebo or Corn oil pill, dietary counseling
Corn oil pill : 2 capsules given twice daily for 12 weeks"
522964|NCT00795717|B1|Baseline|Lovaza Then Placebo|"Lovaza, dietary counseling
Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
522965|NCT00795717|P2|Participant Flow|Placebo Then Lovaza|"Placebo, dietary counseling
Placebo : 2 capsules given twice daily vs. Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks"
522966|NCT00795717|P1|Participant Flow|Lovaza Then Placebo|"Lovaza, dietary counseling
Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks vs. placebo 2 capsules given twice daily."
522967|NCT00795717|O2|Outcome|Placebo|"Placebo, dietary counseling
Placebo : 2 capsules given twice daily"
522968|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling
Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
522969|NCT00795717|O2|Outcome|Placebo|"Placebo, dietary counseling
Placebo : 2 capsules given twice daily"
522970|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling
Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
522971|NCT00795717|O2|Outcome|Placebo|"Corn oil, dietary counseling
Corn oil : 2 capsules given twice daily"
522972|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling
Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
522973|NCT00795717|E2|Reported Event|Placebo|Placebo, dietary counseling
522974|NCT00795717|E1|Reported Event|Lovaza-Active|Lovaza, dietary counseling
522975|NCT00795769|B1|Baseline|Ondansteron Therapy|"Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
ondansetron: Given IV
survey administration: Correlative studies
management of therapy complications: Ondansetron IV"
522976|NCT00795769|P1|Participant Flow|Ondansetron Therapy|"Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
ondansetron: Given IV
survey administration: Correlative studies
management of therapy complications: Ondansetron IV"
522977|NCT00795769|O1|Outcome|Ondansetron Therapy|"Patients receive 16mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
ondansetron: Given IV
survey administration: Correlative studies
management of therapy complications: Ondansetron IV"
522978|NCT00795769|E1|Reported Event|Ondansteron Therapy|"Patients receive 16 mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
ondansetron: Given IV
survey administration: Correlative studies
management of therapy complications: Ondansetron IV"
522979|NCT00795886|B1|Baseline|Rapamycin|This includes all study participants.
522980|NCT00795886|P1|Participant Flow|Rapamycin|This includes all study participants.
522981|NCT00795886|O1|Outcome|Rapamycin|This includes all study participants.
522982|NCT00795886|O1|Outcome|Rapamycin|This includes all study participants.
522983|NCT00795886|O1|Outcome|Rate of Transplant Related Mortality|All participants enrolled in the trial
522984|NCT00795886|E1|Reported Event|Rapamycin|This includes all study participants.
522985|NCT00795951|B1|Baseline|Single Arm Study|All subjects were patched with TRUE Test panels 1.1, 2.1 and 3.1
522986|NCT00795951|P1|Participant Flow|Diagnostic Performance: Nickel Sulfate|Number of subjects with reactions recorded at visit 3 or 4
522987|NCT00795951|O1|Outcome|Itching|Number of subjects who presented with itching at patch removal
522990|NCT00795951|O1|Outcome|Persistent Reactions|Number of subjects who presented with persistent reactions
522991|NCT00795951|O1|Outcome|Late Reactions|Number of subjects who presented with late reactions
522992|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
522993|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
522994|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
522995|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
522996|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
522997|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
522998|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
522999|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523000|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523001|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523002|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523003|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523004|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523005|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523006|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523007|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523008|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523009|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523010|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523011|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523012|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523013|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523014|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523015|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523016|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523017|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523018|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523019|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
523020|NCT00795951|O1|Outcome|Diagnostic Performance: Nickel Sulfate|Number of subjects with a positive reaction to nickel sulfate at visit 3 or visit 4
523021|NCT00795951|E1|Reported Event|Safety|Adverse Events
523022|NCT00796003|B3|Baseline|Total|Total of all reporting groups
523023|NCT00796003|B2|Baseline|Phase I and II: 20 mg/m2|Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I)
523024|NCT00796003|B1|Baseline|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
523025|NCT00796003|P2|Participant Flow|Phase I and II: 20 mg/m2|Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I)
523026|NCT00796003|P1|Participant Flow|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
523027|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
523028|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
523029|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
523030|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
523031|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
523032|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
523033|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
523824|NCT00798317|B3|Baseline|Total|Total of all reporting groups
523034|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
523035|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
523036|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
523037|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
523038|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
523039|NCT00796003|O3|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
523040|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
523041|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
523042|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
523043|NCT00796003|E3|Reported Event|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
523044|NCT00796003|E2|Reported Event|Phase I - 20 mg/m2 Group|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1
523045|NCT00796003|E1|Reported Event|Phase I - 15 mg/m2 Group|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1
523046|NCT00796120|B3|Baseline|Total|Total of all reporting groups
523047|NCT00796120|B2|Baseline|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
523048|NCT00796120|B1|Baseline|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
523049|NCT00796120|P2|Participant Flow|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
523050|NCT00796120|P1|Participant Flow|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
523051|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
523052|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
523053|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
523054|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
523055|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
523056|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
523057|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
523058|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
523059|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
523060|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
523061|NCT00796120|E2|Reported Event|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
523062|NCT00796120|E1|Reported Event|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
523063|NCT00783198|B4|Baseline|Total|Total of all reporting groups
523064|NCT00783198|B3|Baseline|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523065|NCT00783198|B2|Baseline|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523066|NCT00783198|B1|Baseline|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523067|NCT00783198|P3|Participant Flow|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523068|NCT00783198|P2|Participant Flow|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523069|NCT00783198|P1|Participant Flow|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523070|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523071|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523072|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523073|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523074|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523075|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523076|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523077|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523078|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523079|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523080|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523081|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523082|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523083|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523084|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523085|NCT00783198|E3|Reported Event|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523086|NCT00783198|E2|Reported Event|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523087|NCT00783198|E1|Reported Event|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
523088|NCT00783224|B5|Baseline|Total|Total of all reporting groups
523089|NCT00783224|B4|Baseline|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
523090|NCT00783224|B3|Baseline|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
523091|NCT00783224|B2|Baseline|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
523092|NCT00783224|B1|Baseline|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
523093|NCT00783224|P4|Participant Flow|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
523094|NCT00783224|P3|Participant Flow|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
523095|NCT00783224|P2|Participant Flow|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
523096|NCT00783224|P1|Participant Flow|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
523097|NCT00783224|O4|Outcome|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
523098|NCT00783224|O3|Outcome|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
523099|NCT00783224|O2|Outcome|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
523100|NCT00783224|O1|Outcome|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
523101|NCT00783224|E3|Reported Event|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
523102|NCT00783224|E2|Reported Event|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
523825|NCT00798317|B2|Baseline|Placebo|Intravitreal injection of placebo
523103|NCT00783224|E1|Reported Event|Mometasone Furoate Placebo and Fluticasone Propionate Placebo|Both placebo groups (arms) were combined to report adverse events
523105|NCT00783263|B4|Baseline|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
523106|NCT00783263|B3|Baseline|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
523107|NCT00783263|B2|Baseline|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
523108|NCT00783263|B1|Baseline|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
523109|NCT00783263|P4|Participant Flow|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
523110|NCT00783263|P3|Participant Flow|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
523111|NCT00783263|P2|Participant Flow|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
523112|NCT00783263|P1|Participant Flow|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
523113|NCT00783263|O2|Outcome|Rosuvastatin 10 or 20 mg|Participants who received rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
523114|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 or 10 mg tablets once daily for 4 to 5 weeks then received 10 or 20 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
523115|NCT00783263|O4|Outcome|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
523116|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
523117|NCT00783263|O2|Outcome|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
523118|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
523119|NCT00783263|O2|Outcome|Rosuvastatin 10 or 20 mg|Participants who received rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
523120|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 or 10 mg tablets once daily for 4 to 5 weeks then received 10 or 20 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
523121|NCT00783263|O4|Outcome|Rosuvastatin 20 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
523122|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
523123|NCT00783263|O2|Outcome|Rosuvastatin 10 mg (Stratum I)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
523124|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
523125|NCT00783263|O2|Outcome|Rosuvastatin (10 or 20 mg)|Participants who received rosuvastatin (5 or 10 mg) mg tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
523126|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
523127|NCT00783263|O4|Outcome|Rosuvastatin 20 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
523128|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
523129|NCT00783263|O2|Outcome|Rosuvastatin 10 mg (Stratum I)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
523130|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
523131|NCT00783263|O2|Outcome|Rosuvastatin (10 or 20 mg)|Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
523132|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus (5 or 10 mg) rosuvastatin for an additional 6 weeks.
523695|NCT00798161|O1|Outcome|OL: L2.5+M1000BID|Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)
523133|NCT00783263|E4|Reported Event|Rosuva 20 mg|Participants who received rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
523134|NCT00783263|E3|Reported Event|Rosuva 10 mg + EZ 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
523135|NCT00783263|E2|Reported Event|Rosuva 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
523136|NCT00783263|E1|Reported Event|Rosuva 5 mg + EZ 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5mg rosuvastatin for an additional 6 weeks.
523137|NCT00783302|B1|Baseline|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
523138|NCT00783302|P1|Participant Flow|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
523139|NCT00783302|O3|Outcome|Follow-up Period at 12 Months|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 12 months.
523140|NCT00783302|O2|Outcome|Follow-up Period at 6 Months|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 6 months.
523141|NCT00783302|O1|Outcome|Follow-up Period at 1 Month|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 1 month.
523142|NCT00783302|O3|Outcome|Negative Predictive Value - Subject Follow-up Period 12 Months|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
523143|NCT00783302|O2|Outcome|Negative Predictive Value - Subject Follow-up Period 6 Months|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
523144|NCT00783302|O1|Outcome|Negative Predictive Value - Subject Follow-up Period 1 Month|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
523145|NCT00783302|O3|Outcome|Specificity - Subject Follow-up Period 12 Months|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
523146|NCT00783302|O2|Outcome|Specificity - Subject Follow-up Period 6 Months|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
523147|NCT00783302|O1|Outcome|Specificity - Subject Follow-up Period 1 Month|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
523148|NCT00783302|O3|Outcome|Positive Predictive Value - Subject Follow-up Period 12 Months|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
523149|NCT00783302|O2|Outcome|Positive Predictive Value - Subject Follow-up Period 6 Months|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
523150|NCT00783302|O1|Outcome|Positive Predictive Value - Subject Follow-up Period 1 Month|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
523151|NCT00783302|O3|Outcome|Sensitivity - Subject Follow-up Period 12 Months|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
523152|NCT00783302|O2|Outcome|Sensitivity - Subject Follow-up Period 6 Months|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
523153|NCT00783302|O1|Outcome|Sensitivity - Subject Follow-up Period 1 Month|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
523154|NCT00783302|E1|Reported Event|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
523155|NCT00783432|B3|Baseline|Total|Total of all reporting groups
523156|NCT00783432|B2|Baseline|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
523157|NCT00783432|B1|Baseline|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
523158|NCT00783432|P2|Participant Flow|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
523159|NCT00783432|P1|Participant Flow|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
523160|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
523161|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
523162|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
523163|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
523164|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
523165|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
523166|NCT00783432|E2|Reported Event|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
523167|NCT00783432|E1|Reported Event|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
523168|NCT00796224|B3|Baseline|Total|Total of all reporting groups
523169|NCT00796224|B2|Baseline|30 mg/kg Azithromycin IR|Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
523170|NCT00796224|B1|Baseline|60 mg/kg Azithromycin ER|Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
523171|NCT00796224|P2|Participant Flow|30 mg/kg Azithromycin Immediate-release (IR)|Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
523172|NCT00796224|P1|Participant Flow|60 mg/kg Azithromycin Extended-release (ER)|Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
523173|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
523174|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
523175|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
523176|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
523177|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR (Reference)|
523178|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER (Test)|
523190|NCT00796302|B2|Baseline|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
523191|NCT00796302|B1|Baseline|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
523192|NCT00796302|P2|Participant Flow|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
523193|NCT00796302|P1|Participant Flow|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
523194|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
523195|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
523196|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
523197|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
523198|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
523199|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
523200|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and risperidone. Parents will receive parent management training
523201|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
523202|NCT00796302|E2|Reported Event|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
523203|NCT00796302|E1|Reported Event|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
523204|NCT00796315|B1|Baseline|Doxylamine Succinate USP|Doxylamine Succinate, United States Pharmacopeia (USP): One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
523205|NCT00796315|P3|Participant Flow|Subjects Aged 12-17 Years (Doxylamine Suc|Ages 12-17 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
523206|NCT00796315|P2|Participant Flow|Aged 6-11 Years (Doxylamine Succinate|"Ages 6-11 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued."
523207|NCT00796315|P1|Participant Flow|Subjects Aged 2-5 Years (Doxylamine Succinate)|Ages 2-5 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
523208|NCT00796315|O3|Outcome|Subjects Aged 12-17 Years|Ages 12-17 years. Doxylamine Succinate USP
523209|NCT00796315|O2|Outcome|Subjects Aged 6-11 Years|Ages 6-11 years. Doxylamine Succinate USP
523210|NCT00796315|O1|Outcome|Subjects Aged 2-5 Years|Ages 2-5 years. Doxylamine Succinate USP
523211|NCT00796315|O3|Outcome|Subjects Aged 12-17 Years|Ages 12-17 years. All subjects received a dose of 12.5 mg Doxylamine Succinate USP
523212|NCT00796315|O2|Outcome|Subjects Aged 6-11 Years|Ages 6-11 years. Subjects received a dose of 4.17 or 6.25 or 8.33 or 10.42 mg Doxylamine Succinate USP (exact dose dependent upon body weight). Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued.
523213|NCT00796315|O1|Outcome|Subjects Aged 2-5 Years|Ages 2-5 years. Subjects received a dose of either 3.125 or 4.17 mg Doxylamine Succinate USP (exact dose dependent upon body weight)
523214|NCT00796315|E3|Reported Event|Subjects Aged 12-17 Years|Ages 12-17 years. Doxylamine succinate USP
523215|NCT00796315|E2|Reported Event|Aged 6-11 Years|Ages 6-11 years. Doxylamine Succinate USP
523216|NCT00796315|E1|Reported Event|Subjects Aged 2-5 Years|Ages 2-5 years. Doxylamine Succinate USP
523217|NCT00796328|B1|Baseline|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
523218|NCT00796328|P1|Participant Flow|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
523219|NCT00796328|O1|Outcome|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
523220|NCT00796328|E1|Reported Event|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
523221|NCT00796367|B4|Baseline|Total|Total of all reporting groups
523222|NCT00796367|B3|Baseline|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
523223|NCT00796367|B2|Baseline|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
523224|NCT00796367|B1|Baseline|Placebo|Placebo
523225|NCT00796367|P3|Participant Flow|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
523226|NCT00796367|P2|Participant Flow|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
523227|NCT00796367|P1|Participant Flow|Placebo|Placebo
523228|NCT00796367|O3|Outcome|VI-0521 Top|VI-0521 15 mg phentermine/92 mg topiramate
523229|NCT00796367|O2|Outcome|VI-0521 Mid|VI-0521 7.5 mg phentermine/46 mg topiramate
523230|NCT00796367|O1|Outcome|Placebo|Placebo
523231|NCT00796367|O3|Outcome|VI-0521 Top|VI-0521 15 mg phentermine/92 mg topiramate
523232|NCT00796367|O2|Outcome|VI-0521 Mid|VI-0521 7.5 mg phentermine/46 mg topiramate
523233|NCT00796367|O1|Outcome|Placebo|Placebo
523234|NCT00796367|E3|Reported Event|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
523235|NCT00796367|E2|Reported Event|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
523236|NCT00796367|E1|Reported Event|Placebo|Placebo
523237|NCT00796419|B3|Baseline|Total|Total of all reporting groups
523238|NCT00796419|B2|Baseline|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
523239|NCT00796419|B1|Baseline|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
523703|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523240|NCT00796419|P2|Participant Flow|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 6% hetastarch every 8 hours for 5 days
523241|NCT00796419|P1|Participant Flow|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 5% human albumin every 8 hours for 5 days
523242|NCT00796419|O2|Outcome|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
523243|NCT00796419|O1|Outcome|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
523244|NCT00796419|O2|Outcome|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
523245|NCT00796419|O1|Outcome|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
523246|NCT00796419|O2|Outcome|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
523247|NCT00796419|O1|Outcome|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
523248|NCT00796419|E2|Reported Event|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
523249|NCT00796419|E1|Reported Event|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
523250|NCT00796510|B3|Baseline|Total|Total of all reporting groups
523251|NCT00796510|B2|Baseline|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
523252|NCT00796510|B1|Baseline|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
523253|NCT00796510|P2|Participant Flow|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
523254|NCT00796510|P1|Participant Flow|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
523255|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
523256|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
523257|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
523258|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
523259|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
523260|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
523261|NCT00796510|E2|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
523262|NCT00796510|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
523263|NCT00796523|B3|Baseline|Total|Total of all reporting groups
523264|NCT00796523|B2|Baseline|Control Videotape|videotape with normal newborn instruction
523265|NCT00796523|B1|Baseline|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
523266|NCT00796523|P2|Participant Flow|Control Videotape|videotape with normal newborn instruction
523267|NCT00796523|P1|Participant Flow|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
523268|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
523269|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
523270|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
523271|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
523272|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
523273|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
523274|NCT00796549|B1|Baseline|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
523275|NCT00796549|P1|Participant Flow|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
523276|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
523277|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
523278|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
523279|NCT00796549|O2|Outcome|Afatinib 50mg 2nd Line|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
523280|NCT00796549|O1|Outcome|Afatinib 50mg 1st Line|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 1st line anti cancer treatment, indicating that they had not received prior treatment with chemotherapy.
523281|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
533499|NCT00806416|E3|Reported Event|Vitamin D|2800-IU vitamin D3 tablet
523282|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
523283|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
523284|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
523285|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
523286|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
523287|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
523288|NCT00796549|E1|Reported Event|Afatinib 50mg|Afatinib 50mg film coated tablets where administered once daily as long as they were tolerated by patients, until a disease progression (according to the response evaluation criteria in solid tumors)
523289|NCT00796991|B4|Baseline|Total|Total of all reporting groups
523290|NCT00796991|B3|Baseline|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523291|NCT00796991|B2|Baseline|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523292|NCT00796991|B1|Baseline|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523293|NCT00796991|P3|Participant Flow|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523294|NCT00796991|P2|Participant Flow|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523295|NCT00796991|P1|Participant Flow|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523296|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523297|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523320|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523444|NCT00797277|E2|Reported Event|2. IM Haloperidol Pus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization
533500|NCT00806416|E2|Reported Event|Alendronate|70 mg alendronate tablet
523298|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523299|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523300|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523301|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523302|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523303|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523304|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523305|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523306|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523307|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523308|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523332|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523445|NCT00797277|E1|Reported Event|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization
523309|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523310|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523311|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523312|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523313|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523314|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523315|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523316|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523317|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523318|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523319|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523446|NCT00797316|B3|Baseline|Total|Total of all reporting groups
523447|NCT00797316|B2|Baseline|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
523321|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523322|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523323|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523324|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523325|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523326|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523327|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523328|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523329|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523330|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523331|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523448|NCT00797316|B1|Baseline|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
523333|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523334|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523335|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523336|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523337|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523338|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523339|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523340|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523341|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523342|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523343|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523449|NCT00797316|P2|Participant Flow|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
523696|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523344|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523345|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523346|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523347|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523348|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523349|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523350|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523351|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523352|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523353|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523354|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523377|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523450|NCT00797316|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
523355|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523356|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523357|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523358|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523359|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523360|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523361|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523362|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523363|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523364|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523365|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523389|NCT00796991|E3|Reported Event|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523697|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523366|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523367|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523368|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523369|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523370|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523371|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523372|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523373|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523374|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523375|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523376|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523451|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
523698|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523378|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523379|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523380|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523381|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523382|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523383|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523384|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523385|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523386|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523387|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523388|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523452|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
523390|NCT00796991|E2|Reported Event|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523391|NCT00796991|E1|Reported Event|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
523392|NCT00797108|B4|Baseline|Total|Total of all reporting groups
523393|NCT00797108|B3|Baseline|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523394|NCT00797108|B2|Baseline|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523395|NCT00797108|B1|Baseline|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523396|NCT00797108|P3|Participant Flow|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523397|NCT00797108|P2|Participant Flow|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523398|NCT00797108|P1|Participant Flow|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523399|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523400|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523453|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
523489|NCT00797667|P3|Participant Flow|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523401|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523402|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523403|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523404|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523405|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523406|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523407|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523408|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523409|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523410|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523439|NCT00797277|P1|Participant Flow|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.
523411|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523412|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523413|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523414|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523415|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523416|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523417|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523418|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523419|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523420|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523438|NCT00797277|P2|Participant Flow|2. IM Haloperidol Plus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.
523421|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523422|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523423|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523424|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523425|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523426|NCT00797108|E3|Reported Event|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523427|NCT00797108|E2|Reported Event|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523428|NCT00797108|E1|Reported Event|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
523429|NCT00797212|B1|Baseline|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm
523430|NCT00797212|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
523431|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
523432|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
523433|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
523434|NCT00797212|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
523435|NCT00797277|B3|Baseline|Total|Total of all reporting groups
523436|NCT00797277|B2|Baseline|2. IM Haloperidol Pus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization
523437|NCT00797277|B1|Baseline|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization
523440|NCT00797277|O2|Outcome|2. IM Haloperidol Pus Lorazepam|5 mg haloperidol plus 2 mg lorazepam IM injection
523441|NCT00797277|O1|Outcome|1. IM Olanzapine|10 mg olanzapine IM injection
523442|NCT00797277|O2|Outcome|2. IM Haloperidol Plus Lorazepam|5 mg haloperidol plus 2 mg lorazepam IM injection
523454|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
523455|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
523456|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
523457|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
523458|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
523459|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
523460|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
523461|NCT00797316|E2|Reported Event|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
523462|NCT00797316|E1|Reported Event|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
523463|NCT00797459|B1|Baseline|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
523464|NCT00797459|P1|Participant Flow|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
523465|NCT00797459|O2|Outcome|Restylane Side of Face|The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
523466|NCT00797459|O1|Outcome|Restylane-L Side of Face|Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
523467|NCT00797459|O2|Outcome|Restylane-L|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
523468|NCT00797459|O1|Outcome|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
523469|NCT00797459|E2|Reported Event|Restylane Side of Face|The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
523470|NCT00797459|E1|Reported Event|Restylane-L Side of Face|Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
523471|NCT00797511|B1|Baseline|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
523472|NCT00797511|P1|Participant Flow|ADACEL POLIO Vaccine Study Group|Participants received one dose of TdcP-IPV vaccine (ADACEL Polio) on Day 0.
523473|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
523474|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
523475|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
523476|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
523477|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
523478|NCT00797511|E1|Reported Event|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
523479|NCT00797563|B1|Baseline|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
523480|NCT00797563|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
523481|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
523482|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
523483|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
523484|NCT00797563|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
523485|NCT00797667|B4|Baseline|Total|Total of all reporting groups
523486|NCT00797667|B3|Baseline|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523487|NCT00797667|B2|Baseline|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
523488|NCT00797667|B1|Baseline|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523490|NCT00797667|P2|Participant Flow|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
523491|NCT00797667|P1|Participant Flow|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523492|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523493|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
523494|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523495|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523496|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
523497|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523498|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523499|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
523500|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523501|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523502|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
523503|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523504|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523505|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
523506|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523507|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523508|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
523509|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523510|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523511|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
523512|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523513|NCT00797667|E3|Reported Event|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523514|NCT00797667|E2|Reported Event|MK-0974 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
523515|NCT00797667|E1|Reported Event|MK-0974 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
523516|NCT00797797|B3|Baseline|Total|Total of all reporting groups
523517|NCT00797797|B2|Baseline|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
523518|NCT00797797|B1|Baseline|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
523519|NCT00797797|P2|Participant Flow|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
523520|NCT00797797|P1|Participant Flow|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
523521|NCT00797797|O2|Outcome|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
523522|NCT00797797|O1|Outcome|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
523523|NCT00797797|O2|Outcome|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
523524|NCT00797797|O1|Outcome|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
523525|NCT00797797|E2|Reported Event|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
523526|NCT00797797|E1|Reported Event|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
523527|NCT00797823|B4|Baseline|Total|Total of all reporting groups
523528|NCT00797823|B3|Baseline|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
523529|NCT00797823|B2|Baseline|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
523600|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523602|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523530|NCT00797823|B1|Baseline|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
523531|NCT00797823|P3|Participant Flow|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
523532|NCT00797823|P2|Participant Flow|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
523533|NCT00797823|P1|Participant Flow|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
523534|NCT00797823|O2|Outcome|Active Comparator: Insulin Plus Glucagon|Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
523535|NCT00797823|O1|Outcome|Placebo Comparator: Insulin Alone|No glucagon given during closed loop control-insulin only
523536|NCT00797823|O2|Outcome|Active Comparator: Insulin Plus Glucagon|Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
523537|NCT00797823|O1|Outcome|Placebo Comparator: Insulin Alone|No glucagon given during closed loop control-insulin only
523538|NCT00797823|E3|Reported Event|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
523539|NCT00797823|E2|Reported Event|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
523540|NCT00797823|E1|Reported Event|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
523541|NCT00797862|B4|Baseline|Total|Total of all reporting groups
523542|NCT00797862|B3|Baseline|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523543|NCT00797862|B2|Baseline|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523544|NCT00797862|B1|Baseline|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523545|NCT00797862|P3|Participant Flow|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523546|NCT00797862|P2|Participant Flow|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523601|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
523547|NCT00797862|P1|Participant Flow|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523548|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523549|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523550|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523551|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523552|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523553|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523554|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523555|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523556|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523557|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523558|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523699|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523559|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523560|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523561|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523562|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523563|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523564|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523565|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523566|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523567|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523568|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523569|NCT00797862|E3|Reported Event|Amlodipine|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523570|NCT00797862|E2|Reported Event|Aliskiren|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523603|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523571|NCT00797862|E1|Reported Event|Aliskiren + Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
523572|NCT00797966|B5|Baseline|Total|Total of all reporting groups
523573|NCT00797966|B4|Baseline|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523574|NCT00797966|B3|Baseline|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523575|NCT00797966|B2|Baseline|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
523576|NCT00797966|B1|Baseline|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523577|NCT00797966|P6|Participant Flow|Participants in Phase A+|Based on the response at Week 8 (in Phase A), participants were either randomized to Phase B or continued single-blind treatment in Phase A+. Participants who met the criteria for a response at Week 8 were not to be randomized into Phase B but continued to receive single-blind placebo plus the maximum tolerated dose of ADT from Week 8 for an additional 6 weeks in Phase A+.
523578|NCT00797966|P5|Participant Flow|Participants in Phase A|Participants entered Phase A (single-blind prospective treatment) during which participants had received single-blind placebo plus an open-label commercially available ADT for 8 weeks at maximally tolerated doses.
523579|NCT00797966|P4|Participant Flow|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523580|NCT00797966|P3|Participant Flow|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523581|NCT00797966|P2|Participant Flow|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523582|NCT00797966|P1|Participant Flow|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523583|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523584|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523585|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
523586|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523587|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523588|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523589|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523590|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523591|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523592|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523593|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523594|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523595|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523596|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523597|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
523598|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523599|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523694|NCT00798161|O1|Outcome|OL: L2.5+M1000BID|Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)
523604|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523605|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523606|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523607|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523608|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523609|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523610|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523611|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523612|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523613|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523614|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523615|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523616|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523617|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523618|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523619|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523620|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523621|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523622|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523623|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
523624|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523625|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523626|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523627|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523628|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523629|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523630|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523631|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523632|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523633|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523634|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523635|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523636|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523637|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523638|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523639|NCT00797966|E4|Reported Event|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523640|NCT00797966|E3|Reported Event|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523641|NCT00797966|E2|Reported Event|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523642|NCT00797966|E1|Reported Event|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
523643|NCT00798018|B5|Baseline|Total|Total of all reporting groups
523644|NCT00798018|B4|Baseline|Tetracaine|1% tetracaine was used to inflate the cuff
523645|NCT00798018|B3|Baseline|Lidocaine|2% lidiocaine was used to inflate the cuff
523646|NCT00798018|B2|Baseline|Normal Saline|normal saline was used to inflate the cuff
523647|NCT00798018|B1|Baseline|Air Alone|Only air was injected into the cuff, as the routine practice
523648|NCT00798018|P4|Participant Flow|Tetracaine|1% tetracaine was used to inflate the cuff
523649|NCT00798018|P3|Participant Flow|Lidocaine|2% lidiocaine was used to inflate the cuff
523650|NCT00798018|P2|Participant Flow|Normal Saline|normal saline was used to inflate the cuff
523651|NCT00798018|P1|Participant Flow|Air Alone|Only air was injected into the cuff, as the routine practice
523652|NCT00798018|O4|Outcome|Tetracaine|1% tetracaine was used to inflate the cuff
523653|NCT00798018|O3|Outcome|Lidocaine|2% lidiocaine was used to inflate the cuff
523654|NCT00798018|O2|Outcome|Normal Saline|normal saline was used to inflate the cuff
523655|NCT00798018|O1|Outcome|Air Alone|Only air was injected into the cuff, as the routine practice
523656|NCT00798018|E4|Reported Event|Tetracaine|1% tetracaine was used to inflate the cuff
523657|NCT00798018|E3|Reported Event|Lidocaine|2% lidiocaine was used to inflate the cuff
523658|NCT00798018|E2|Reported Event|Normal Saline|normal saline was used to inflate the cuff
523659|NCT00798018|E1|Reported Event|Air Alone|Only air was injected into the cuff, as the routine practice
523660|NCT00798096|B1|Baseline|Overall Study|1-fostamatinib 200mg, BID, Oral
523661|NCT00798096|P1|Participant Flow|Overall Study|1-fostamatinib 200mg, BID, Oral
523662|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
523663|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
523664|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
523665|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
523666|NCT00798096|E1|Reported Event|Overall Study|1-fostamatinib 200mg, BID, Oral
523667|NCT00798135|B1|Baseline|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
523668|NCT00798135|P1|Participant Flow|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
523669|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
523670|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
523671|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
523672|NCT00798135|E1|Reported Event|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
523673|NCT00798161|B8|Baseline|Total|Total of all reporting groups
523674|NCT00798161|B7|Baseline|L2.5+M1000BID (Open Label)|Open label set: Linagliptin 2.5mg + Metformin 1000mg BID
523675|NCT00798161|B6|Baseline|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523676|NCT00798161|B5|Baseline|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523677|NCT00798161|B4|Baseline|Lina5|Patients treated with Linagliptin 5mg OD
523678|NCT00798161|B3|Baseline|M1000BID|Patients treated with Metformin 1000mg BID
523679|NCT00798161|B2|Baseline|M500BID|Patients treated with Metformin 500mg BID
523680|NCT00798161|B1|Baseline|Placebo|Patients treated with matching placebo
523681|NCT00798161|P7|Participant Flow|OL: L2.5+M1000 BID|Open label set: Linagliptin 2.5 mg + Metformin 1000 mg BID
523682|NCT00798161|P6|Participant Flow|L2.5 + M1000 BID|Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg BID
523683|NCT00798161|P5|Participant Flow|L2.5+M500 BID|Patients treated with Linagliptin 2.5 mg + Metformin 500 mg BID
523684|NCT00798161|P4|Participant Flow|Lina 5|Patients treated with Linagliptin 5 mg once daily (OD)
523685|NCT00798161|P3|Participant Flow|M1000 BID|Patients treated with Metformin 1000 mg BID
523686|NCT00798161|P2|Participant Flow|M500 Twice Daily (BID)|Patients treated with Metformin 500 mg BID
523687|NCT00798161|P1|Participant Flow|Placebo|Patients treated with matching placebo
523688|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523689|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523690|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523691|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523692|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523693|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523704|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523705|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523706|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523707|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523708|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523709|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523710|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523711|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523712|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523713|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523714|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523715|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523716|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523717|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523718|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523719|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523720|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523721|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523722|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523723|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523724|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523725|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523726|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523727|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523728|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523729|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523730|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523731|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523732|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523733|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523734|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523735|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523736|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523737|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523738|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523739|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523740|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523741|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523742|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523743|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523744|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523745|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523746|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523747|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523748|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523749|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523750|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523751|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523752|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523753|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523754|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523755|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523756|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523757|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523758|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523759|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523760|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523761|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523762|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523763|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523764|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523765|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523766|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523767|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523768|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523769|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523770|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523771|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523772|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523773|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523774|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523775|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523776|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523777|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523778|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523779|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523780|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
523781|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
523782|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
523783|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
523784|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
523785|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
523786|NCT00798161|E7|Reported Event|OL: L2.5+M1000 BID|Open label set: Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
523787|NCT00798161|E6|Reported Event|L2.5 + M1000 BID|Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
523788|NCT00798161|E5|Reported Event|L2.5+M500 BID|Patients treated with Linagliptin 2.5 mg + Metformin 500 mg bis in die (BID)
523789|NCT00798161|E4|Reported Event|Lina 5|Patients treated with Linagliptin 5 mg once daily (OD)
523790|NCT00798161|E3|Reported Event|M1000 BID|Patients treated with Metformin 1000 mg bis in die (BID)
523791|NCT00798161|E2|Reported Event|M500 BID|Patients treated with Metformin 500 mg BID
523792|NCT00798161|E1|Reported Event|Placebo|Patients treated with matching placebo
523793|NCT00798304|B4|Baseline|Total|Total of all reporting groups
523794|NCT00798304|B3|Baseline|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
523795|NCT00798304|B2|Baseline|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
523796|NCT00798304|B1|Baseline|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
523797|NCT00798304|P3|Participant Flow|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
523798|NCT00798304|P2|Participant Flow|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
523799|NCT00798304|P1|Participant Flow|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
523800|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
523801|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
523802|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
523803|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
523804|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
523805|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
523806|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
523807|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
523808|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
523809|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
523810|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
523811|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
523812|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
523813|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
523814|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
523815|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
523816|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
523817|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
523818|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
523819|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
523820|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
523821|NCT00798304|E3|Reported Event|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
523822|NCT00798304|E2|Reported Event|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
523823|NCT00798304|E1|Reported Event|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
523826|NCT00798317|B1|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
523827|NCT00798317|P2|Participant Flow|Placebo|Intravitreal injection of placebo
523828|NCT00798317|P1|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
523829|NCT00798317|O2|Outcome|Placebo|Intravitreal injection of placebo
523830|NCT00798317|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
523831|NCT00798317|O2|Outcome|Placebo|Intravitreal injection of placebo
523832|NCT00798317|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
523833|NCT00798317|E2|Reported Event|Placebo|Intravitreal injection of placebo
523834|NCT00798317|E1|Reported Event|Ocriplasmin 125ug|125ug ocriplasmin intravitreal injection
523835|NCT00798369|B7|Baseline|Total|Total of all reporting groups
523836|NCT00798369|B6|Baseline|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
523837|NCT00798369|B5|Baseline|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523838|NCT00798369|B4|Baseline|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523839|NCT00798369|B3|Baseline|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523840|NCT00798369|B2|Baseline|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523841|NCT00798369|B1|Baseline|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523842|NCT00798369|P6|Participant Flow|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
523843|NCT00798369|P5|Participant Flow|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523844|NCT00798369|P4|Participant Flow|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523845|NCT00798369|P3|Participant Flow|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523846|NCT00798369|P2|Participant Flow|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523847|NCT00798369|P1|Participant Flow|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523848|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
523849|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523850|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523851|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
524409|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524413|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
523852|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523853|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523854|NCT00798369|O1|Outcome|Linear Model|The linear model was the best-fitting model out of the 4 selected models (Emax, Logistic, Linear in Log-dose, Linear)with lowest Akaike Information Criterion (AIC).
523855|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
523856|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523857|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523858|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523859|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523860|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523861|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
523862|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523863|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523864|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523865|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523866|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523867|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
523868|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523869|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523870|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
524057|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
523871|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523872|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523873|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
523874|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523875|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523876|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523877|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523878|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523879|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
523880|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523881|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523882|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523883|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523884|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523885|NCT00798369|E6|Reported Event|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
523886|NCT00798369|E5|Reported Event|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523887|NCT00798369|E4|Reported Event|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523888|NCT00798369|E3|Reported Event|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523912|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
524410|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
523889|NCT00798369|E2|Reported Event|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523890|NCT00798369|E1|Reported Event|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
523891|NCT00798434|B3|Baseline|Total|Total of all reporting groups
523892|NCT00798434|B2|Baseline|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523893|NCT00798434|B1|Baseline|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523894|NCT00798434|P2|Participant Flow|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523895|NCT00798434|P1|Participant Flow|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 milligrams (mg) once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523896|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523897|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523898|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523899|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523900|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523901|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523902|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523903|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523904|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523905|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523906|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523907|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523908|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523909|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523910|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523911|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523913|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523914|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523915|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523916|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to 8 mg once daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523917|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523918|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to 8 mg once daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523919|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523920|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523921|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523922|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523923|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523924|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523925|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523926|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523927|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523928|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523929|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523930|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523931|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523932|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523933|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523934|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523935|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523936|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523937|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523938|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
524056|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
523939|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523940|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523941|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523942|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523943|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523944|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523945|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523946|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523947|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523948|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523949|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523950|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523951|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523952|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523953|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523954|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523955|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523956|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523957|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523958|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523959|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523960|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523961|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523962|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523963|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523964|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523965|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523966|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523967|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
523968|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
523969|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
524411|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
523970|NCT00798434|E4|Reported Event|Placebo/Fesoterodine Open-label|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). SAEs and non-serious AEs reported for these participants only during the open-label phase.
523971|NCT00798434|E3|Reported Event|Festerodine/Fesoterodine Open-Label|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). Serious adverse events (SAEs) and non-serious adverse events (AEs) reported reported for these participants only during the open-label phase.
523972|NCT00798434|E2|Reported Event|Fesoterodine Double-Blind|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded)
523973|NCT00798434|E1|Reported Event|Placebo Double-Blind|Participants received matched placebo once daily from baseline to Week 12 (double-blinded)
523974|NCT00798486|B1|Baseline|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
523975|NCT00798486|P1|Participant Flow|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
523976|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
523977|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
523978|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
523979|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
523980|NCT00798486|E1|Reported Event|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
523981|NCT00798577|B3|Baseline|Total|Total of all reporting groups
523982|NCT00798577|B2|Baseline|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
523983|NCT00798577|B1|Baseline|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
523984|NCT00798577|P2|Participant Flow|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
523985|NCT00798577|P1|Participant Flow|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
523986|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
523987|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
523988|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
523989|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
523990|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
523991|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
523992|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
523993|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
523994|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
523995|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
523996|NCT00798577|E2|Reported Event|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
523997|NCT00798577|E1|Reported Event|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
523998|NCT00798590|B3|Baseline|Total|Total of all reporting groups
523999|NCT00798590|B2|Baseline|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
524000|NCT00798590|B1|Baseline|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
524001|NCT00798590|P2|Participant Flow|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
524002|NCT00798590|P1|Participant Flow|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
524003|NCT00798590|O2|Outcome|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
524004|NCT00798590|O1|Outcome|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
524005|NCT00798590|O2|Outcome|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
524006|NCT00798590|O1|Outcome|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
524007|NCT00798590|E2|Reported Event|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
524008|NCT00798590|E1|Reported Event|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
524009|NCT00798603|B1|Baseline|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524010|NCT00798603|P1|Participant Flow|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524011|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524012|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524013|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524014|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524015|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524016|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524017|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524018|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524019|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524020|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524021|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524022|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524023|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524024|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524025|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524026|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524027|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524028|NCT00798603|E1|Reported Event|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
524029|NCT00798655|B1|Baseline|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
524030|NCT00798655|P1|Participant Flow|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
524031|NCT00798655|O1|Outcome|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
524032|NCT00798655|O1|Outcome|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
524033|NCT00798655|E1|Reported Event|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
524034|NCT00798707|B4|Baseline|Total|Total of all reporting groups
524035|NCT00798707|B3|Baseline|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524036|NCT00798707|B2|Baseline|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524037|NCT00798707|B1|Baseline|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524038|NCT00798707|P3|Participant Flow|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524039|NCT00798707|P2|Participant Flow|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524040|NCT00798707|P1|Participant Flow|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524041|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524042|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524043|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524044|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524045|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524046|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524047|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524048|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524049|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524050|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524051|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524052|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524053|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524054|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524055|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524058|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524059|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524060|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524061|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524062|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524063|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524064|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524065|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524066|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524067|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524068|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524069|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524070|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524071|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524072|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524073|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524074|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524075|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524076|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524077|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524078|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524079|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524080|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524081|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524082|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524083|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524084|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524085|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524086|NCT00798707|E3|Reported Event|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
524087|NCT00798707|E2|Reported Event|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
524088|NCT00798707|E1|Reported Event|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
524089|NCT00798720|B1|Baseline|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2
vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle
bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
524090|NCT00798720|P1|Participant Flow|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2
vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle
bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
524091|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2
vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle
bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
524092|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2
vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle
bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
524093|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2
vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle
bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
524094|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2
vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle
bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
524095|NCT00798720|E1|Reported Event|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2
vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle
bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
524096|NCT00798759|B3|Baseline|Total|Total of all reporting groups
524097|NCT00798759|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
524098|NCT00798759|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
524099|NCT00798759|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
524100|NCT00798759|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
524101|NCT00798759|O2|Outcome|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
524102|NCT00798759|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
524103|NCT00798759|O2|Outcome|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
524104|NCT00798759|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
524105|NCT00798759|E2|Reported Event|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
524106|NCT00798759|E1|Reported Event|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
524201|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524107|NCT00798889|B1|Baseline|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
524108|NCT00798889|P1|Participant Flow|Sunitinib|Sunitinib 50 milligram (mg) capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
524109|NCT00798889|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
524110|NCT00798889|E1|Reported Event|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
524111|NCT00798967|B3|Baseline|Total|Total of all reporting groups
524112|NCT00798967|B2|Baseline|Placebo|Matching sc dose of placebo to teduglutide
524113|NCT00798967|B1|Baseline|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
524114|NCT00798967|P2|Participant Flow|Placebo|Matching sc dose of placebo to teduglutide
524115|NCT00798967|P1|Participant Flow|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
524116|NCT00798967|O2|Outcome|Placebo|Matching sc dose of placebo to teduglutide
524117|NCT00798967|O1|Outcome|Teduglutide|0.05 mg/kg/day sc dose of teduglutide
524118|NCT00798967|O2|Outcome|Placebo|Matching sc dose of placebo to teduglutide
524119|NCT00798967|O1|Outcome|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
524120|NCT00798967|E2|Reported Event|Placebo|Matching sc dose of placebo to teduglutide
524121|NCT00798967|E1|Reported Event|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
524122|NCT00799227|B1|Baseline|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
524123|NCT00799227|P1|Participant Flow|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
524124|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
524125|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
524126|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
524127|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
524128|NCT00799227|E1|Reported Event|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
524129|NCT00799292|B3|Baseline|Total|Total of all reporting groups
524130|NCT00799292|B2|Baseline|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
524131|NCT00799292|B1|Baseline|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
524132|NCT00799292|P2|Participant Flow|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
524133|NCT00799292|P1|Participant Flow|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
524134|NCT00799292|O2|Outcome|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
524135|NCT00799292|O1|Outcome|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
524136|NCT00799396|B1|Baseline|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.
Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days
Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
524137|NCT00799396|P1|Participant Flow|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.
Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days
Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
524138|NCT00799396|O1|Outcome|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.
Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days
Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment
PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation
PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation"
524139|NCT00799396|O1|Outcome|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.
Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days
Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment
PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation
PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation"
524140|NCT00799396|E1|Reported Event|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.
Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days
Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
524141|NCT00799409|B4|Baseline|Total|Total of all reporting groups
524142|NCT00799409|B3|Baseline|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
524143|NCT00799409|B2|Baseline|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
524144|NCT00799409|B1|Baseline|Not Randomized|Children who started dose adjustment period, but were not randomized
524145|NCT00799409|P3|Participant Flow|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
524146|NCT00799409|P2|Participant Flow|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
524147|NCT00799409|P1|Participant Flow|Not Randomized|Children who started dose adjustment period, but were not randomized
524148|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524149|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524150|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524151|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524152|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524153|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524154|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524155|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524156|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524157|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524158|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524159|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524160|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524161|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524162|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524163|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524164|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524165|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524166|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524167|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524168|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524169|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524170|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524171|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524172|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524173|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524174|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524175|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524176|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524177|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524178|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524179|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524180|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524181|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524182|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524183|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524184|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524185|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524186|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524187|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524188|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524189|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524190|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524191|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524192|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524193|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524194|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524195|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524196|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524197|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524198|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524199|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524200|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524202|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524203|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524204|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524205|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524206|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524207|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524208|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524209|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524210|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524211|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524212|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524213|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524214|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524215|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524216|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524217|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524218|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524219|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524220|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524221|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524222|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524223|NCT00799409|E3|Reported Event|Open Label/Non-Lab Day CONCERTA|Dose adjustment period and double blind period other than lab school day
524224|NCT00799409|E2|Reported Event|Concerta|Concerta was received during the lab school day
524225|NCT00799409|E1|Reported Event|Placebo|Placebo was received during the lab school day
524226|NCT00799422|B1|Baseline|Overall|Baseline characteristics are presented for all participants completing all three treatment sequences.
524227|NCT00799422|P6|Participant Flow|Clear Care / Complete / ReNu|Clear Care, then Complete Easy Rub, then ReNu MultiPlus, 1 week each
524228|NCT00799422|P5|Participant Flow|Complete / ReNu / Clear Care|Complete Easy Rub, then ReNu MultiPlus), then Clear Care, 1 week each
524229|NCT00799422|P4|Participant Flow|ReNu / Clear Care / Complete|ReNu MultiPlus, then Clear Care, then Complete Easy Rub, 1 week each
524230|NCT00799422|P3|Participant Flow|Clear Care / ReNu / Complete|Clear Care, then ReNu MultiPlus, then Complete Easy Rub, 1 week each
524231|NCT00799422|P2|Participant Flow|Complete / Clear Care / ReNu|Complete Easy Rub, then Clear Care, then ReNu MultiPlus, 1 week each
524232|NCT00799422|P1|Participant Flow|ReNu / Complete / Clear Care|ReNu Multiplus, then Complete Easy Rub, then Clear Care, 1 week each
524233|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
524234|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
524235|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
524236|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
524237|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
524238|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
524239|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
524240|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
524241|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
524242|NCT00799422|E3|Reported Event|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
524243|NCT00799422|E2|Reported Event|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
524244|NCT00799422|E1|Reported Event|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
524245|NCT00799474|B1|Baseline|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
524246|NCT00799474|P1|Participant Flow|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
524247|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
524248|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
524249|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
524250|NCT00799474|E1|Reported Event|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
524251|NCT00799487|B4|Baseline|Total|Total of all reporting groups
524252|NCT00799487|B3|Baseline|Concerta/Placebo|Children randomized to receive Concerta at lab school day 1 and Placebo at lab school day 2
524253|NCT00799487|B2|Baseline|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and Concerta lab school day 2
524254|NCT00799487|B1|Baseline|Not Randomized|Children who started dose adjustment period, but were not randomized
524255|NCT00799487|P3|Participant Flow|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
524256|NCT00799487|P2|Participant Flow|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
524257|NCT00799487|P1|Participant Flow|Not Randomized|Children who started dose adjustment period, but were not randomized
524258|NCT00799487|O3|Outcome|Concerta|Chilfdren randomized to receive Concerta at lab school day 1 or lab school day 2
524259|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524260|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524261|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524262|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524263|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524264|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524265|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524266|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524267|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524268|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524269|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524270|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524271|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524272|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524273|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524274|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524275|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524276|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524277|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524278|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524279|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524280|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524281|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524282|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524283|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524284|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524285|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524286|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524287|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524288|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524289|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524290|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524291|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524292|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524293|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524294|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524295|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524296|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524297|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524298|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524299|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524300|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524301|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524302|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524303|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524304|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524305|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524306|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524307|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524308|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524309|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524310|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or at lab school day 2
524311|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524312|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524313|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524314|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524315|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524316|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524317|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524318|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524319|NCT00799487|O2|Outcome|Placebo|Chidren randomized to receive Placebo at lab school day 1 or lab school day 2
524320|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524321|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524322|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524323|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524324|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524325|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524326|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524327|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524328|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524329|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524330|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
524331|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
524332|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
524333|NCT00799487|E3|Reported Event|Open Label|dose adjustment period and double blind period other than lab school day
524334|NCT00799487|E2|Reported Event|Concerta|Concerta was received during the lab school day
524335|NCT00799487|E1|Reported Event|Placebo|Placebo was received during the lab school day
524336|NCT00786422|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
524337|NCT00786422|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
524338|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
524339|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
524340|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
524341|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
524342|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
524343|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
524344|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
524345|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
524346|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
524347|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
524348|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
524349|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
524350|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
524351|NCT00786422|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
524352|NCT00786474|B3|Baseline|Total|Total of all reporting groups
524353|NCT00786474|B2|Baseline|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
524354|NCT00786474|B1|Baseline|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
524355|NCT00786474|P2|Participant Flow|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
524356|NCT00786474|P1|Participant Flow|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
524357|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
524358|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
524359|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
524360|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
524361|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
524362|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
524363|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
524364|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
524365|NCT00786474|E2|Reported Event|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
524366|NCT00786474|E1|Reported Event|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
524367|NCT00786487|B5|Baseline|Total|Total of all reporting groups
524368|NCT00786487|B4|Baseline|Glycerol Untrained|"glycerol infusion into untrained subjects
glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
524369|NCT00786487|B3|Baseline|Lipid Untrained|"lipid infusion into untrained subjects
20% lipid infusion: 1.5 ml/min for 6 hours"
524370|NCT00786487|B2|Baseline|Glycerol Trained|"glycerol infusion into trained subjects
glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
524371|NCT00786487|B1|Baseline|Lipid Trained|"20% lipid infusion in trained subjects
20% lipid infusion: 1.5 ml/min for 6 hours"
524372|NCT00786487|P4|Participant Flow|Glycerol Untrained|"glycerol infusion into untrained subjects
glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
524373|NCT00786487|P3|Participant Flow|Lipid Untrained|"lipid infusion into untrained subjects
20% lipid infusion: 1.5 ml/min for 6 hours"
524374|NCT00786487|P2|Participant Flow|Glycerol Trained|"glycerol infusion into trained subjects
glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
524375|NCT00786487|P1|Participant Flow|Lipid Trained|"20% lipid infusion in trained subjects
20% lipid infusion: 1.5 ml/min for 6 hours"
524376|NCT00786487|O4|Outcome|Glycerol Untrained|"glycerol infusion into untrained subjects
glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
524377|NCT00786487|O3|Outcome|Lipid Untrained|"lipid infusion into untrained subjects
20% lipid infusion: 1.5 ml/min for 6 hours"
524378|NCT00786487|O2|Outcome|Glycerol Trained|"glycerol infusion into trained subjects
glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
524379|NCT00786487|O1|Outcome|Lipid Trained|"20% lipid infusion in trained subjects
20% lipid infusion: 1.5 ml/min for 6 hours"
524380|NCT00786487|E4|Reported Event|Glycerol Untrained|"glycerol infusion into untrained subjects
glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
524381|NCT00786487|E3|Reported Event|Lipid Untrained|"lipid infusion into untrained subjects
20% lipid infusion: 1.5 ml/min for 6 hours"
524382|NCT00786487|E2|Reported Event|Glycerol Trained|"glycerol infusion into trained subjects
glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
524383|NCT00786487|E1|Reported Event|Lipid Trained|"20% lipid infusion in trained subjects
20% lipid infusion: 1.5 ml/min for 6 hours"
524384|NCT00786565|B1|Baseline|Akreos Intraocular Lens|
524385|NCT00786565|P1|Participant Flow|Akreos Intraocular Lens|Subjects randomised to receive Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
524386|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524387|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524388|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524389|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524390|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524391|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524392|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524393|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524394|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524395|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524396|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524397|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524398|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524399|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524400|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524401|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524402|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524403|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524404|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524405|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524406|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524407|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524415|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524416|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524417|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524418|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
524419|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
524420|NCT00786565|E2|Reported Event|Akreos Adapt Intraocular Lens|Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
524421|NCT00786565|E1|Reported Event|Akreos Advanced Intraocular Lenses|Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
524422|NCT00786643|B3|Baseline|Total|Total of all reporting groups
524423|NCT00786643|B2|Baseline|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
524424|NCT00786643|B1|Baseline|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
524425|NCT00786643|P2|Participant Flow|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
524426|NCT00786643|P1|Participant Flow|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
524427|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
524428|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
524429|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
524430|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
524431|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
524432|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
524433|NCT00786643|E2|Reported Event|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
524434|NCT00786643|E1|Reported Event|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
524435|NCT00786682|B1|Baseline|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days."
524436|NCT00786682|P1|Participant Flow|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days."
524437|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days."
524438|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days."
524439|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days."
524440|NCT00786682|E1|Reported Event|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days."
524441|NCT00786799|B3|Baseline|Total|Total of all reporting groups
524442|NCT00786799|B2|Baseline|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
524443|NCT00786799|B1|Baseline|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
524444|NCT00786799|P2|Participant Flow|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
524445|NCT00786799|P1|Participant Flow|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
524446|NCT00786799|O2|Outcome|Placebo Group: Change in TNFα|
524447|NCT00786799|O1|Outcome|Active Omega-3 Group: Change in TNFα|
524448|NCT00786799|O2|Outcome|Placebo Group: Change in Levels of Omega 3 Fatty Acids|Change in percentage of serum levels of Omega-3 fatty acids in the placebo group (100% * ((One Year - Baseline)/Baseline).
524449|NCT00786799|O1|Outcome|Active Omega-3 Group: Change in Levels of Omega 3 Fatty Acids|Change in percentage of serum levels of Omega-3 fatty acids in the active Omega-3 group (100% * ((One Year - Baseline)/Baseline)
524450|NCT00786799|O3|Outcome|Comparison Between Omega-3 and Placebo Groups|Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score between Omega-3 and Placebo groups (p-value given in statistical analysis section)
524451|NCT00786799|O2|Outcome|Placebo|Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Placebo Group Only
524452|NCT00786799|O1|Outcome|Active Omega-3|Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Omega-3 Group Only
524581|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524453|NCT00786799|E2|Reported Event|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
524454|NCT00786799|E1|Reported Event|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
524455|NCT00786838|B1|Baseline|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524456|NCT00786838|P1|Participant Flow|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524457|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
524458|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1.
524459|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524460|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
524461|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524462|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
524463|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524464|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
524465|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524466|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
524467|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524468|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
524469|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524470|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
524471|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524472|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
524473|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524474|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
524475|NCT00786838|O1|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524476|NCT00786838|O1|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524477|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
524478|NCT00786838|O1|Outcome|Placebo|Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
524479|NCT00786838|E1|Reported Event|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
524480|NCT00786864|B3|Baseline|Total|Total of all reporting groups
524481|NCT00786864|B2|Baseline|Control Group|Control group - no intervention
524482|NCT00786864|B1|Baseline|Exercise Intervention Group|Experimental Group
524483|NCT00786864|P2|Participant Flow|Control Group|Control group - no intervention
524484|NCT00786864|P1|Participant Flow|Exercise Intervention Group|Experimental Group
524485|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
524486|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
524487|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
524488|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
524489|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
524490|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
524491|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
524492|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
524493|NCT00786864|E2|Reported Event|Control Group|Control group - no intervention
524494|NCT00786864|E1|Reported Event|Exercise Intervention Group|Experimental Group
524495|NCT00786916|B4|Baseline|Total|Total of all reporting groups
524496|NCT00786916|B3|Baseline|Group C|"Lidocaine 0.5 mg/kg
lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
524497|NCT00786916|B2|Baseline|Group B|"Lidocaine 0.25 mg/kg
lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
524498|NCT00786916|B1|Baseline|Group A|"Saline
normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
534287|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
524499|NCT00786916|P3|Participant Flow|Group C|"Lidocaine 0.5 mg/kg
lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
524500|NCT00786916|P2|Participant Flow|Group B|"Lidocaine 0.25 mg/kg
lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
524501|NCT00786916|P1|Participant Flow|Group A|"Saline
normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
524502|NCT00786916|O3|Outcome|Group C|"Lidocaine 0.5 mg/kg
lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
524503|NCT00786916|O2|Outcome|Group B|"Lidocaine 0.25 mg/kg
lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
524504|NCT00786916|O1|Outcome|Group A|"Saline
normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
524505|NCT00786916|E3|Reported Event|Group C|0.50 mg/kg Lidocaine Group
524506|NCT00786916|E2|Reported Event|Group B|0.25 mg/kg Lidocaine Group
524507|NCT00786916|E1|Reported Event|Group A|Placebo (Saline) Group
524508|NCT00786994|B5|Baseline|Total|Total of all reporting groups
524509|NCT00786994|B4|Baseline|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day (27 patients)
Placebo (petroleum jelly)"
524510|NCT00786994|B3|Baseline|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day (27 patients)
Placebo (petroleum jelly)"
524511|NCT00786994|B2|Baseline|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day (54 patients)
Oleogel-S10: topical use once or twice daily"
524512|NCT00786994|B1|Baseline|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day (54 patients)
Oleogel-S10: topical use once or twice daily"
524513|NCT00786994|P4|Participant Flow|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day (27 patients)
Placebo (petroleum jelly)"
524514|NCT00786994|P3|Participant Flow|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day (27 patients)
Placebo (petroleum jelly)"
524515|NCT00786994|P2|Participant Flow|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day (54 patients)
Oleogel-S10: topical use once or twice daily"
524516|NCT00786994|P1|Participant Flow|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day (54 patients)
Oleogel-S10: topical use once or twice daily"
524517|NCT00786994|O3|Outcome|C/D - Placebo Once or Twice Daily|"Placebo (petroleum jelly) for three months once or twice a day
Placebo (petroleum jelly)"
524518|NCT00786994|O2|Outcome|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day
Oleogel-S10: topical use once or twice daily"
524519|NCT00786994|O1|Outcome|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day
Oleogel-S10: topical use once or twice daily"
524520|NCT00786994|E4|Reported Event|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day
Placebo (petroleum jelly)"
524521|NCT00786994|E3|Reported Event|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day
Placebo (petroleum jelly)"
524522|NCT00786994|E2|Reported Event|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day
Oleogel-S10: topical use once or twice daily"
524523|NCT00786994|E1|Reported Event|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day
Oleogel-S10: topical use once or twice daily"
524524|NCT00787020|B3|Baseline|Total|Total of all reporting groups
524525|NCT00787020|B2|Baseline|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
524526|NCT00787020|B1|Baseline|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
524527|NCT00787020|P2|Participant Flow|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
524528|NCT00787020|P1|Participant Flow|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
524580|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524529|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
524530|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
524531|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
524532|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
524533|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
524534|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
524535|NCT00787020|E2|Reported Event|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
524536|NCT00787020|E1|Reported Event|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
524537|NCT00787124|B3|Baseline|Total|Total of all reporting groups
524538|NCT00787124|B2|Baseline|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
524539|NCT00787124|B1|Baseline|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
524540|NCT00787124|P2|Participant Flow|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
524541|NCT00787124|P1|Participant Flow|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
524542|NCT00787124|O2|Outcome|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
524543|NCT00787124|O1|Outcome|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
524544|NCT00787124|O2|Outcome|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
524545|NCT00787124|O1|Outcome|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
524546|NCT00787124|E2|Reported Event|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
524547|NCT00787124|E1|Reported Event|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
524548|NCT00787137|B4|Baseline|Total|Total of all reporting groups
524549|NCT00787137|B3|Baseline|Placebo|Control, phosphate-buffered saline
524550|NCT00787137|B2|Baseline|PG102 1 mg/kg|Second dose PG102
524551|NCT00787137|B1|Baseline|PG102 0.3 mg/kg|Lowest dose PG102
524552|NCT00787137|P3|Participant Flow|Placebo|Control, phosphate-buffered saline
524553|NCT00787137|P2|Participant Flow|PG102 1 mg/kg|Second dose PG102
524554|NCT00787137|P1|Participant Flow|PG102 0.3 mg/kg|Lowest dose PG102
524555|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
524556|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
524557|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
524558|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
524559|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
524560|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
524561|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
524562|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
524563|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
524564|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
524565|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
524566|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
524567|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
524568|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
524569|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
524570|NCT00787137|E3|Reported Event|Placebo|Control, phosphate-buffered saline
524571|NCT00787137|E2|Reported Event|PG102 1 mg/kg|Second dose PG102
524572|NCT00787137|E1|Reported Event|PG102 0.3 mg/kg|Lowest dose PG102
524573|NCT00787150|B4|Baseline|Total|Total of all reporting groups
524574|NCT00787150|B3|Baseline|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524575|NCT00787150|B2|Baseline|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524576|NCT00787150|B1|Baseline|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524577|NCT00787150|P3|Participant Flow|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524578|NCT00787150|P2|Participant Flow|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524579|NCT00787150|P1|Participant Flow|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524582|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524583|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524584|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524585|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524586|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524587|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524588|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524589|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524590|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524591|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524592|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524593|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524594|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524595|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524596|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524597|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524598|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524599|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524600|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524601|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524602|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524603|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524604|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524605|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524606|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524607|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524608|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524609|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524610|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524611|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524612|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524664|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524665|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524613|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524614|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524615|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524616|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524617|NCT00787150|E3|Reported Event|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524618|NCT00787150|E2|Reported Event|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
524619|NCT00787150|E1|Reported Event|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
524620|NCT00787189|B3|Baseline|Total|Total of all reporting groups
524621|NCT00787189|B2|Baseline|Control|Placebo laser device
524622|NCT00787189|B1|Baseline|Active|Active laser device
524623|NCT00787189|P2|Participant Flow|Control|Placebo laser device
524624|NCT00787189|P1|Participant Flow|Active|Active laser device
524625|NCT00787189|O2|Outcome|Control|Placebo laser device
524626|NCT00787189|O1|Outcome|Active|Active laser device
524627|NCT00787189|E2|Reported Event|Control|Placebo laser device
524628|NCT00787189|E1|Reported Event|Active|Active laser device
524629|NCT00787202|B6|Baseline|Total|Total of all reporting groups
524630|NCT00787202|B5|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524631|NCT00787202|B4|Baseline|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524632|NCT00787202|B3|Baseline|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524633|NCT00787202|B2|Baseline|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
524634|NCT00787202|B1|Baseline|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
524635|NCT00787202|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524636|NCT00787202|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524637|NCT00787202|P3|Participant Flow|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524638|NCT00787202|P2|Participant Flow|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 milligram (mg) orally twice daily for 8 weeks.
524639|NCT00787202|P1|Participant Flow|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
524640|NCT00787202|O4|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524641|NCT00787202|O3|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524642|NCT00787202|O2|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524643|NCT00787202|O1|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
524644|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524645|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524646|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524647|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
524648|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
524649|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524650|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524651|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524652|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
524653|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
524654|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524655|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524656|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524657|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
524658|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
524659|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524660|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524661|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524662|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
524663|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
524666|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524667|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
524668|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
524669|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524670|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524671|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524672|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
524673|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
524674|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524675|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524676|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524677|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
524678|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
524679|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524680|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524681|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524682|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
524683|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
524684|NCT00787202|E5|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
524685|NCT00787202|E4|Reported Event|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
524686|NCT00787202|E3|Reported Event|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
524687|NCT00787202|E2|Reported Event|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
524688|NCT00787202|E1|Reported Event|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
524689|NCT00787241|B4|Baseline|Total|Total of all reporting groups
524690|NCT00787241|B3|Baseline|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
524691|NCT00787241|B2|Baseline|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
524692|NCT00787241|B1|Baseline|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
524693|NCT00787241|P3|Participant Flow|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
524694|NCT00787241|P2|Participant Flow|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
524695|NCT00787241|P1|Participant Flow|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
524696|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
524697|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
524698|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
524699|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
524700|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
524701|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
524702|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
524703|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
524704|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
524705|NCT00787241|E3|Reported Event|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
524706|NCT00787241|E2|Reported Event|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
524707|NCT00787241|E1|Reported Event|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
524708|NCT00787254|B3|Baseline|Total|Total of all reporting groups
524709|NCT00787254|B2|Baseline|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524710|NCT00787254|B1|Baseline|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524711|NCT00787254|P2|Participant Flow|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524712|NCT00787254|P1|Participant Flow|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524963|NCT00787904|P1|Participant Flow|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
524713|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524714|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524715|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524716|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524717|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524718|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524719|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524720|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524721|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524722|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524723|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524724|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524725|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524726|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524727|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524728|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524729|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524730|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524731|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524732|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524733|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524734|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524735|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524736|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524737|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524738|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524739|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524740|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524741|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524742|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524743|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524744|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524745|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524746|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524747|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524748|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524749|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524750|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524751|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524752|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524753|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524754|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524755|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524756|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524757|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524758|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524759|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524760|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524761|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524762|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524763|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524764|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524765|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524766|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524767|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524768|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524769|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524770|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524771|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524772|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524773|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524774|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524775|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524776|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524777|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524778|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524779|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524780|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524781|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524782|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524783|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524784|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524785|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524786|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524787|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524788|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524789|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524790|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524791|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524792|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524793|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524794|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524795|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524796|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524797|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524798|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524799|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524800|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524801|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524802|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524803|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524804|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524805|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524806|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524807|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524808|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524809|NCT00787254|E2|Reported Event|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
524810|NCT00787254|E1|Reported Event|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
524811|NCT00787267|B1|Baseline|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
524812|NCT00787267|P1|Participant Flow|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
524813|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
524814|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
524815|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
524816|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
524817|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
524818|NCT00787267|E1|Reported Event|Evalulable Patients That Received Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
524819|NCT00787319|B1|Baseline|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524820|NCT00787319|P1|Participant Flow|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524821|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524822|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524823|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524897|NCT00787644|P1|Participant Flow|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
524901|NCT00787644|E1|Reported Event|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
524824|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524825|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524826|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524827|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524828|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524829|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524830|NCT00787319|E1|Reported Event|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
524831|NCT00787332|B3|Baseline|Total|Total of all reporting groups
524832|NCT00787332|B2|Baseline|Argatroban®|Patients with suspected HIT randomized to IV Argatroban®
524833|NCT00787332|B1|Baseline|Desirudin|Patients with suspected HIT randomized to SC Desirudin i
524834|NCT00787332|P2|Participant Flow|Argatroban®|Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
524835|NCT00787332|P1|Participant Flow|Desirudin|Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
524836|NCT00787332|O2|Outcome|Argatroban®|Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
524837|NCT00787332|O1|Outcome|Desirudin|Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
524838|NCT00787332|E2|Reported Event|Argatroban®|Patients with suspected HIT randomized to IV Argatroban®
524839|NCT00787332|E1|Reported Event|Desirudin|Patients with suspected HIT randomized to SC Desirudin i
524840|NCT00787527|B1|Baseline|Zolinza + CHOP|"Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)
Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle
Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle
Zolinza (vorinostat) : Starting oral dose (Schedule A) of 300 mg once a day on Days 5-14 of 21 day cycle.
Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle
Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
524841|NCT00787527|P1|Participant Flow|Zolinza + CHOP|"Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)
Doxorubicin: 50 mg/m^2 by vein/intravenous (IV) over 15 minutes on Day 1 of 21 day cycle
Prednisone: 100 mg tablets by mouth/orally (PO) once a day on Days 1-5 of 21 day cycle
Zolinza (vorinostat): Phase I Starting dose of 300 mg by mouth each evening on Days 5-14 of 21 day cycle.
Cyclophosphamide: 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle
Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
524842|NCT00787527|O1|Outcome|Schedule B - Vorinostat Three Times Daily|"Vorinostat administered orally 300 mg three times daily from days -2 to 3 (4500 mg over 5 days per cycle) of 21 day cycle.
Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)
Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle
Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle
Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle
Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
524843|NCT00787527|O2|Outcome|Schedule A - Vorinostat Twice Daily|"Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle
Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)
Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle
Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle
Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle
Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
524844|NCT00787527|O1|Outcome|Schedule A - Vorinostat Once Daily|"Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle
Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)
Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle
Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle
Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle
Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
524845|NCT00787527|O1|Outcome|Schedule A - Vorinostat Once or Twice Daily|"Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle or Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle
Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)
Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle
Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle
Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle
Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
524846|NCT00787527|E2|Reported Event|Schedule B: Vorinostat Three Times Daily|"Phase II: Vorinostat administered at starting dose 300 mg orally three times daily from Days -2 to 3 (4500 mg over 5 days per cycle).
Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1."
524898|NCT00787644|O2|Outcome|2. Placebo|Placebo: Matching placebo (inert tablet)
524899|NCT00787644|O1|Outcome|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
524900|NCT00787644|E2|Reported Event|2. Placebo|Placebo: Matching placebo (inert tablet)
524847|NCT00787527|E1|Reported Event|Schedule A: Vorinostat Once or Twice Daily|"Phase I: Vorinostat administered Days 5 to 14 at starting dose 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), next administered dose 200 mg orally twice daily (4000 mg over 10 days per cycle).
Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1."
524848|NCT00787566|B4|Baseline|Total|Total of all reporting groups
524849|NCT00787566|B3|Baseline|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
524850|NCT00787566|B2|Baseline|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
524851|NCT00787566|B1|Baseline|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
524852|NCT00787566|P3|Participant Flow|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
524853|NCT00787566|P2|Participant Flow|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
524854|NCT00787566|P1|Participant Flow|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
524855|NCT00787566|O3|Outcome|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
524856|NCT00787566|O2|Outcome|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
524857|NCT00787566|O1|Outcome|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
524858|NCT00787566|E3|Reported Event|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
524859|NCT00787566|E2|Reported Event|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
524860|NCT00787566|E1|Reported Event|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
524861|NCT00787605|B3|Baseline|Total|Total of all reporting groups
524862|NCT00787605|B2|Baseline|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
524863|NCT00787605|B1|Baseline|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
524864|NCT00787605|P2|Participant Flow|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
524865|NCT00787605|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
524866|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
524867|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
524868|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
524869|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
524870|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
524871|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
524872|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
524873|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
524874|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
524875|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
524876|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
524877|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
524878|NCT00787605|E2|Reported Event|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
524879|NCT00787605|E1|Reported Event|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
524880|NCT00787618|B4|Baseline|Total|Total of all reporting groups
524881|NCT00787618|B3|Baseline|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.
50 mg Proellex: Single dose"
524882|NCT00787618|B2|Baseline|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.
50 mg Proellex: Single dose"
524883|NCT00787618|B1|Baseline|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.
50 mg Proellex: Single dose"
524884|NCT00787618|P3|Participant Flow|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.
50 mg Proellex: Single dose"
524885|NCT00787618|P2|Participant Flow|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.
50 mg Proellex: Single dose"
524886|NCT00787618|P1|Participant Flow|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.
50 mg Proellex: Single dose"
524887|NCT00787618|O3|Outcome|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.
50 mg Proellex: Single dose"
524888|NCT00787618|O2|Outcome|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.
50 mg Proellex: Single dose"
524889|NCT00787618|O1|Outcome|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.
50 mg Proellex: Single dose"
524890|NCT00787618|E3|Reported Event|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.
50 mg Proellex: Single dose"
524891|NCT00787618|E2|Reported Event|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.
50 mg Proellex: Single dose"
524892|NCT00787618|E1|Reported Event|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.
50 mg Proellex: Single dose"
524893|NCT00787644|B3|Baseline|Total|Total of all reporting groups
524894|NCT00787644|B2|Baseline|2. Placebo|Placebo: Matching placebo (inert tablet)
524895|NCT00787644|B1|Baseline|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
524896|NCT00787644|P2|Participant Flow|2. Placebo|Placebo: Matching placebo (inert tablet)
524902|NCT00787761|B1|Baseline|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
524903|NCT00787761|P1|Participant Flow|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
524904|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
524905|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
524906|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
524907|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
524908|NCT00787761|O1|Outcome|Severe Graft Versus Host Disease|patients receiving transplant using ATG/Bu/Flu/Cy per this protocol and who had severe graft versus host disease as a post-transplant complication
524909|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
524910|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
524911|NCT00787761|O1|Outcome|Transplant Recipients|patients receiving transplant using ATG/Bu/Flu/Cy per this protocol
524912|NCT00787761|E1|Reported Event|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
524913|NCT00787787|B1|Baseline|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.
sunitinib malate: Given PO
capecitabine: Given PO"
524914|NCT00787787|P1|Participant Flow|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.
sunitinib malate: Given PO
capecitabine: Given PO"
524915|NCT00787787|O1|Outcome|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.
sunitinib malate: Given PO
capecitabine: Given PO"
524916|NCT00787787|O1|Outcome|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.
sunitinib malate: Given PO
capecitabine: Given PO"
524917|NCT00787787|O1|Outcome|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.
sunitinib malate: Given PO
capecitabine: Given PO"
524918|NCT00787787|E1|Reported Event|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.
sunitinib malate: Given PO
capecitabine: Given PO"
524919|NCT00787800|B3|Baseline|Total|Total of all reporting groups
524920|NCT00787800|B2|Baseline|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
524921|NCT00787800|B1|Baseline|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
524922|NCT00787800|P2|Participant Flow|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
524923|NCT00787800|P1|Participant Flow|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
524924|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
525557|NCT00789724|O1|Outcome|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
524964|NCT00787904|O2|Outcome|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
524925|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
524926|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
524927|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
524928|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
524929|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
524930|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
524931|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
524932|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
524933|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
524934|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
524935|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
524936|NCT00787800|E2|Reported Event|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
524937|NCT00787800|E1|Reported Event|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
524938|NCT00787891|B3|Baseline|Total|Total of all reporting groups
524939|NCT00787891|B2|Baseline|Rabeprazole 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524940|NCT00787891|B1|Baseline|Rabeprazole 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524941|NCT00787891|P2|Participant Flow|Rabeprazole 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524942|NCT00787891|P1|Participant Flow|Rabeprazole 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524943|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524944|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524945|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524946|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524947|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524948|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524949|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524950|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524951|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524952|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524953|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524954|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524955|NCT00787891|E4|Reported Event|Rabeprazole 1.0 mg/kg (Double-blind Maintenance Phase|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524956|NCT00787891|E3|Reported Event|Rabeprazole 0.5 mg/kg (Double-blind Maintenance Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524957|NCT00787891|E2|Reported Event|Rabeprazole 1.0 mg/kg (Short-term Double-blinde Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524958|NCT00787891|E1|Reported Event|Rabeprazole 0.5 mg/kg (Short-term Double-blinde Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
524959|NCT00787904|B3|Baseline|Total|Total of all reporting groups
524960|NCT00787904|B2|Baseline|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
524961|NCT00787904|B1|Baseline|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
524962|NCT00787904|P2|Participant Flow|Surgical Control|Pre-menopausal women with or without surgery
525558|NCT00789724|E2|Reported Event|Placebo|0.67 ml of NaCl 0.9% solution
524965|NCT00787904|O1|Outcome|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
524966|NCT00787904|O2|Outcome|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
524967|NCT00787904|O1|Outcome|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
524968|NCT00787904|E2|Reported Event|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
524969|NCT00787904|E1|Reported Event|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
524970|NCT00787917|B3|Baseline|Total|Total of all reporting groups
524971|NCT00787917|B2|Baseline|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
524972|NCT00787917|B1|Baseline|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
524973|NCT00787917|P2|Participant Flow|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
524974|NCT00787917|P1|Participant Flow|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
524975|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
524976|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
524977|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
524978|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
524979|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
524980|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
524981|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
525041|NCT00788255|E3|Reported Event|32.9 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
525137|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
524982|NCT00787917|O1|Outcome|Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
524983|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
524984|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
524985|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
524986|NCT00787917|O1|Outcome|Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
524987|NCT00787917|E3|Reported Event|Open Label Omalizumab|Patients who completed double-blinded phase of the study, enrolled into 6 months open label phase and continued in the same regimen of omalizumab as they were during double-blinded phase. A maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
524988|NCT00787917|E2|Reported Event|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
524989|NCT00787917|E1|Reported Event|Blinded Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
524990|NCT00787930|B1|Baseline|Naturalistic Treatment|
524991|NCT00787930|P1|Participant Flow|Naturalistic Treatment|Acutely manic subjects were treated using the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) expert consensus guidelines beginning with valproic acid (titrated to therapeutic levels) over a three week period. If there was a non-response to this intervention, then a subject would continue acute treatment using other interventions indicated by STEP-BD protocols. After stabilization, subjects were followed monthly up to a year's duration and treated using the STEP-BD expert consensus guidelines.
524992|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.
MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.
YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
524993|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.
MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.
YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
524994|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|"Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) <15 or Montgomery Asberg Depression Rating Scale (MADRS) scales <15.
MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.
YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
525028|NCT00788073|O1|Outcome|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)
Study Design:
Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
525029|NCT00788073|E2|Reported Event|Placebo|variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
524995|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.
MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.
YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
524996|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the YMRS or MADRS scales.
524997|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the YMRS or MADRS scales.
524998|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the YMRS or MADRS scales.
524999|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the YMRS or MADRS scales.
525000|NCT00787930|O2|Outcome|Non-Responders to Acute Treatment|Subjects in an acute manic episode who did not respond to treatment as measured by a YMRS >15 by week 3.
525001|NCT00787930|O1|Outcome|Responders to Acute Treatment|Subjects in an acute manic episode who responded to treatment as measured by a Young Mania Rating Scale (YMRS) <15 by week 3, which was the protocol-defined determination point for response to treatment.
525002|NCT00787930|E1|Reported Event|Naturalistic Treatment|Patients were treated acutely using expert consensus guidelines beginning with valproic acid. After stabilization, subjects were followed monthly up to a year's duration and treated using expert consensus guidelines. indicated.
525003|NCT00787943|B1|Baseline|All Study Participants|Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
525004|NCT00787943|P1|Participant Flow|All Study Participants|Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
525005|NCT00787943|O4|Outcome|Pustules: Benzoyl Peroxide 10.0% Cream Formulation #2|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
525006|NCT00787943|O3|Outcome|Papules: Benzoyl Peroxide 10.0% Cream Formulation #2|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
525007|NCT00787943|O2|Outcome|Pustules: Benzoyl Peroxide 10.0% Cream Formulation #1|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
525008|NCT00787943|O1|Outcome|Papules: Benzoyl Peroxide 10.0% Cream Formulation #1|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
525009|NCT00787943|E2|Reported Event|Benzoyl Peroxide 10.0% Cream: Formulation #2|Formulation #2 applied to one side of the face by all 10 subjects.
525010|NCT00787943|E1|Reported Event|Benzoyl Peroxide 10.0% Cream Formulation #1|Formulation #1 applied to one side of the face by all 10 subjects.
525011|NCT00788008|B3|Baseline|Total|Total of all reporting groups
525012|NCT00788008|B2|Baseline|Propofol|Total intravenous anesthesia with propofol
525013|NCT00788008|B1|Baseline|Isoflurane|Inhalational anesthesia with isoflurane
525014|NCT00788008|P2|Participant Flow|Propofol|Total intravenous anesthesia with propofol
525015|NCT00788008|P1|Participant Flow|Isoflurane|Inhalational anesthesia with isoflurane
525016|NCT00788008|O2|Outcome|Propofol|Total intravenous anesthesia with propofol
525017|NCT00788008|O1|Outcome|Isoflurane|Inhalational anesthesia with isoflurane
525018|NCT00788008|E2|Reported Event|Propofol|Total intravenous anesthesia with propofol
525019|NCT00788008|E1|Reported Event|Isoflurane|Inhalational anesthesia with isoflurane
525020|NCT00788073|B3|Baseline|Total|Total of all reporting groups
525021|NCT00788073|B2|Baseline|Placebo|placebo variable dose (same flexible dose titration protocol) bid to tid, oral, 4weeks
525022|NCT00788073|B1|Baseline|STX209|STX209 Variable dose, 1mg bid to 10mg tid, oral capsules, 4weeks
525023|NCT00788073|P2|Participant Flow|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)
Study Design:
Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
525024|NCT00788073|P1|Participant Flow|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)
Study Design:
Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
525025|NCT00788073|O2|Outcome|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)
Study Design:
Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
525026|NCT00788073|O1|Outcome|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)
Study Design:
Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
525027|NCT00788073|O2|Outcome|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)
Study Design:
Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
525030|NCT00788073|E1|Reported Event|STX209|STX209 variable dose from 1mg bid to 10mg tid, capsule, oral, 4 weeks
525042|NCT00788255|E2|Reported Event|30.1 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
525031|NCT00788255|B1|Baseline|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
525032|NCT00788255|P1|Participant Flow|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
525033|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
525034|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
525035|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
525036|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
525037|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
525038|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
525039|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:
Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
525040|NCT00788255|E4|Reported Event|0 μU/mL Exogenous Oxytocin|Thromboelastography on native blood sample.
534960|NCT00817336|O2|Outcome|Placebo|Placebo: oral
525043|NCT00788255|E1|Reported Event|22.5 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
525044|NCT00788372|B1|Baseline|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525045|NCT00788372|P1|Participant Flow|Fentanyl|Fentanyl transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525046|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525047|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525048|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525049|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525050|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525051|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525052|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525053|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525054|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525055|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525056|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525057|NCT00788372|E1|Reported Event|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
525058|NCT00788593|B1|Baseline|Entire Study Population|Includes participants who received placebo, EUR-1008 (APT-1008) high dose first and EUR-1008 (APT-1008) low dose first.
525059|NCT00788593|P3|Participant Flow|EUR-1008 (APT-1008) Low Dose, Then High Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
525132|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
525133|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
525060|NCT00788593|P2|Participant Flow|EUR-1008 (APT-1008) High Dose, Then Low Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
525061|NCT00788593|P1|Participant Flow|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).
525062|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525063|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525064|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525065|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525066|NCT00788593|O3|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525067|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525068|NCT00788593|O1|Outcome|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules, orally daily, for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008)
525069|NCT00788593|O3|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525070|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525071|NCT00788593|O1|Outcome|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules, orally daily, for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008)
525072|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525073|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525074|NCT00788593|E3|Reported Event|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525134|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
525135|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
525136|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
525075|NCT00788593|E2|Reported Event|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
525076|NCT00788593|E1|Reported Event|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsule orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).
525077|NCT00788697|B1|Baseline|ITD Population|All patients who received SonoVue and enrolled in the efficacy phase, had a definite final diagnosis from truth standard and unenhanced and SonoVue-enhanced ultrasonography available
525078|NCT00788697|P1|Participant Flow|Safety Population|All patients who received SonoVue (training and efficacy phases)
525079|NCT00788697|O2|Outcome|CE-US|CE-US Inter-reader agreement
525080|NCT00788697|O1|Outcome|UE-US|UE-US Inter-reader agreement
525081|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
525082|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
525083|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
525084|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
525085|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
525086|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
525087|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
525088|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
525089|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
525090|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
525091|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
525092|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
525093|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
525094|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
525095|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
525096|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
525097|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
525098|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
525099|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
525100|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
525101|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
525102|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
525103|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
525104|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
525105|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
525106|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
525107|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
525108|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
525109|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
525110|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
525111|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
525112|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
525113|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
525114|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
525115|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
525116|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
525117|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
525118|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
525119|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
525120|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
525121|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
525122|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 unenhanced (UE) US assessment
525123|NCT00788697|E1|Reported Event|Safety Population|All patients who received SonoVue (training and efficacy phases)
525124|NCT00788710|B4|Baseline|Total|Total of all reporting groups
525125|NCT00788710|B3|Baseline|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
525126|NCT00788710|B2|Baseline|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
525127|NCT00788710|B1|Baseline|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
525128|NCT00788710|P3|Participant Flow|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
525129|NCT00788710|P2|Participant Flow|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
525130|NCT00788710|P1|Participant Flow|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
525131|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
525138|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
525139|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
525140|NCT00788710|E3|Reported Event|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
525141|NCT00788710|E2|Reported Event|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
525142|NCT00788710|E1|Reported Event|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
525143|NCT00788775|B3|Baseline|Total|Total of all reporting groups
525144|NCT00788775|B2|Baseline|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525145|NCT00788775|B1|Baseline|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525146|NCT00788775|P2|Participant Flow|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525147|NCT00788775|P1|Participant Flow|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525148|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525149|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525150|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525151|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525152|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525153|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525154|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525155|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525156|NCT00788775|E2|Reported Event|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525157|NCT00788775|E1|Reported Event|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
525158|NCT00788957|B5|Baseline|Total|Total of all reporting groups
525159|NCT00788957|B4|Baseline|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525160|NCT00788957|B3|Baseline|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525161|NCT00788957|B2|Baseline|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525162|NCT00788957|B1|Baseline|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525163|NCT00788957|P6|Participant Flow|Part 3: Ganitumab|Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
525261|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
534961|NCT00817336|O1|Outcome|D-serine|"60 mg/kg/day
D Serine: 60 mg/kg/day"
525633|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525164|NCT00788957|P5|Participant Flow|Part 3: Rilotumumab|Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
525165|NCT00788957|P4|Participant Flow|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525166|NCT00788957|P3|Participant Flow|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525167|NCT00788957|P2|Participant Flow|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525168|NCT00788957|P1|Participant Flow|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525169|NCT00788957|O1|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525170|NCT00788957|O1|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525171|NCT00788957|O1|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525172|NCT00788957|O1|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525173|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525174|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525175|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525176|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525177|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525178|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525179|NCT00788957|O2|Outcome|Rilotumumab|Pharmacokinetics of rilotumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525180|NCT00788957|O1|Outcome|Panitumumab|Pharmacokinetics of panitumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525181|NCT00788957|O2|Outcome|Rilotumumab|Pharmacokinetics of rilotumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525182|NCT00788957|O1|Outcome|Panitumumab|Pharmacokinetics of panitumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525183|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525184|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525185|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525186|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525187|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525188|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525189|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525190|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525262|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
535211|NCT00811252|B4|Baseline|Total|Total of all reporting groups
525191|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525192|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525193|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525194|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525195|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525196|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525197|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525198|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525199|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525200|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525201|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525202|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525203|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525204|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525205|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525206|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525207|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525208|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525209|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525210|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525211|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525212|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525213|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525214|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525215|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525216|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525217|NCT00788957|E4|Reported Event|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525218|NCT00788957|E3|Reported Event|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525263|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
535358|NCT00811473|B2|Baseline|Placebo|Matching placebo
525219|NCT00788957|E2|Reported Event|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525220|NCT00788957|E1|Reported Event|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
525221|NCT00789035|B6|Baseline|Total|Total of all reporting groups
525222|NCT00789035|B5|Baseline|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525223|NCT00789035|B4|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
525224|NCT00789035|B3|Baseline|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
525225|NCT00789035|B2|Baseline|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525226|NCT00789035|B1|Baseline|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525227|NCT00789035|P5|Participant Flow|Metformin OL|Patients were to take a open-label (OL) dose of 500 mg Metformin twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525228|NCT00789035|P4|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
525229|NCT00789035|P3|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
525230|NCT00789035|P2|Participant Flow|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525231|NCT00789035|P1|Participant Flow|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525232|NCT00789035|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
525233|NCT00789035|O2|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
525234|NCT00789035|O1|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525235|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525236|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
525237|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
525238|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525239|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525240|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525241|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
525242|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
525243|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525244|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525245|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525246|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
525247|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
525248|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525249|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525250|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525251|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
525252|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
525253|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525254|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525255|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525256|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
525257|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
525258|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525259|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525260|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525264|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525265|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525266|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
525267|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
525268|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525269|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525270|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525271|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
525272|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
525273|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525274|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525275|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525276|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
525277|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
525278|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525279|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525280|NCT00789035|E5|Reported Event|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
525281|NCT00789035|E4|Reported Event|Empagliflozin 25 mg qd|Patients receive 25 mg Empagliflozin in tablets once daily.
525282|NCT00789035|E3|Reported Event|Empagliflozin 10 mg qd|Patients receive 10 mg Empagliflozin in tablets once daily.
525283|NCT00789035|E2|Reported Event|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
525284|NCT00789035|E1|Reported Event|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
525285|NCT00789074|B3|Baseline|Total|Total of all reporting groups
525286|NCT00789074|B2|Baseline|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
525287|NCT00789074|B1|Baseline|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
525288|NCT00789074|P2|Participant Flow|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
525289|NCT00789074|P1|Participant Flow|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
525290|NCT00789074|O2|Outcome|Placebo|
525291|NCT00789074|O1|Outcome|Varenicline Pre-treatment|
525292|NCT00789074|O2|Outcome|Placebo|
525293|NCT00789074|O1|Outcome|Varenicline Pre-treatment|
525294|NCT00789074|O2|Outcome|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
525295|NCT00789074|O1|Outcome|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
525296|NCT00789074|O2|Outcome|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
525297|NCT00789074|O1|Outcome|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
525298|NCT00789074|O2|Outcome|Placebo|
525299|NCT00789074|O1|Outcome|Varenicline|
525300|NCT00789074|O2|Outcome|Placebo|
525301|NCT00789074|O1|Outcome|Varenicline|
525302|NCT00789074|E2|Reported Event|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
525303|NCT00789074|E1|Reported Event|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
525304|NCT00789113|B1|Baseline|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
525305|NCT00789113|P1|Participant Flow|Extended Release Lamotrigine|"Extended Release Lamotrigine
Extended Release Lamotrigine"
525306|NCT00789113|O2|Outcome|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
525307|NCT00789113|O1|Outcome|Immediate Release (IR) Lamotrigine|Study population was on chronic IR lamotrigine therapy and first period of the study was a continuation of standard treatment with IR lamotrigine.
525308|NCT00789113|E1|Reported Event|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
525309|NCT00789191|B3|Baseline|Total|Total of all reporting groups
525310|NCT00789191|B2|Baseline|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525311|NCT00789191|B1|Baseline|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525312|NCT00789191|P2|Participant Flow|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525632|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525313|NCT00789191|P1|Participant Flow|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525314|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525315|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525316|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525317|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525318|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525319|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525320|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525321|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525322|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525323|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525324|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525325|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525326|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525327|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525328|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525329|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525330|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525331|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525332|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525333|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525334|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525335|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525336|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525337|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525338|NCT00789191|E2|Reported Event|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
525339|NCT00789191|E1|Reported Event|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
525340|NCT00789256|B3|Baseline|Total|Total of all reporting groups
525341|NCT00789256|B2|Baseline|Strata 2|will include patients who have received prior medical intervention for their disease.
525342|NCT00789256|B1|Baseline|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
525343|NCT00789256|P2|Participant Flow|Strata 2|will include patients who have received prior medical intervention for their disease.
525344|NCT00789256|P1|Participant Flow|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
525345|NCT00789256|O2|Outcome|Strata 2|will include patients who have received prior medical intervention for their disease.
525346|NCT00789256|O1|Outcome|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
525347|NCT00789256|E2|Reported Event|Strata 2|will include patients who have received prior medical intervention for their disease.
525348|NCT00789256|E1|Reported Event|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
525349|NCT00789321|B3|Baseline|Total|Total of all reporting groups
525350|NCT00789321|B2|Baseline|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
525351|NCT00789321|B1|Baseline|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
525352|NCT00789321|P2|Participant Flow|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
525353|NCT00789321|P1|Participant Flow|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
525354|NCT00789321|O2|Outcome|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
525355|NCT00789321|O1|Outcome|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
525356|NCT00789321|O2|Outcome|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
525357|NCT00789321|O1|Outcome|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
525358|NCT00789321|E2|Reported Event|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
525359|NCT00789321|E1|Reported Event|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
525360|NCT00789373|B1|Baseline|Induction Pemetrexed + Cisplatin|pemetrexed plus cisplatin
525361|NCT00789373|P3|Participant Flow|Pemetrexed + Cisplatin Followed by Placebo|Following Induction, received placebo (normal saline [0.9% sodium chloride]) administered IV on Day 1 of every 21-day cycle plus Best Supportive Care until PD or treatment discontinuation.
525362|NCT00789373|P2|Participant Flow|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|Following Induction, received 500 mg/m^2 maintenance pemetrexed, IV, on Day 1 of each 21-day cycle plus Best Supportive Care until progressive disease (PD) or treatment discontinuation.
525363|NCT00789373|P1|Participant Flow|Induction Pemetrexed + Cisplatin|"pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles.
cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles."
525364|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
525365|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
525366|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
525367|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed and best supportive care
525368|NCT00789373|O2|Outcome|Pemetrexed Plus Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
525369|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
525370|NCT00789373|O2|Outcome|Pemetrexed Plus Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
525371|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
525372|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
525373|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
525374|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
525375|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
525376|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
525377|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
525378|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed and cisplatin followed by placebo plus best supportive care
525379|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
525380|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
525381|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
525382|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
525383|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
525384|NCT00789373|E3|Reported Event|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed and cisplatin followed by placebo plus best supportive care
525385|NCT00789373|E2|Reported Event|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
525386|NCT00789373|E1|Reported Event|Induction Pemetrexed + Cisplatin|"pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles.
cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles."
525387|NCT00789438|B4|Baseline|Total|Total of all reporting groups
525388|NCT00789438|B3|Baseline|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
525389|NCT00789438|B2|Baseline|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
525390|NCT00789438|B1|Baseline|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
525391|NCT00789438|P3|Participant Flow|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
525392|NCT00789438|P2|Participant Flow|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
525393|NCT00789438|P1|Participant Flow|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
525394|NCT00789438|O3|Outcome|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
525395|NCT00789438|O2|Outcome|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
525396|NCT00789438|O1|Outcome|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
525397|NCT00789438|E3|Reported Event|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
525398|NCT00789438|E2|Reported Event|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
525399|NCT00789438|E1|Reported Event|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
525400|NCT00789477|B6|Baseline|Total|Total of all reporting groups
525401|NCT00789477|B5|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
525402|NCT00789477|B4|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
525403|NCT00789477|B3|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
535737|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
525404|NCT00789477|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
525405|NCT00789477|B1|Baseline|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
525406|NCT00789477|P5|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria to week 52
525407|NCT00789477|P4|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
525408|NCT00789477|P3|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2 mg every 4 weeks to week 52
525409|NCT00789477|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
525410|NCT00789477|P1|Participant Flow|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
525411|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
525412|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
525413|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
525414|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
525415|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
525416|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
525417|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
525418|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
525419|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
525420|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
525421|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
525422|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
525423|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
525424|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
525425|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
525426|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
525427|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
525428|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
525429|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
525430|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
525431|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
525432|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
525433|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
525434|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
525435|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
525436|NCT00789477|E5|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
525437|NCT00789477|E4|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
525438|NCT00789477|E3|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
525439|NCT00789477|E2|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
525440|NCT00789477|E1|Reported Event|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
525441|NCT00789529|B3|Baseline|Total|Total of all reporting groups
525442|NCT00789529|B2|Baseline|2 - Opti-Free RepleniSH First|Opti-Free RepleniSH first, ReNu MultiPlus Second
525443|NCT00789529|B1|Baseline|1 - ReNu MultiPlus First|Used ReNu MultiPlus first, Opti-Free RepleniSH Second
525444|NCT00789529|P2|Participant Flow|2 - Opti-Free RepleniSH First, ReNu MultiPlus Second|Used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the first intervention period, and used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the second intervention period
525445|NCT00789529|P1|Participant Flow|1 - ReNu MultiPlus First, Opti-Free RepleniSH Second|Used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the first intervention period, and used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the second intervention period
525446|NCT00789529|O2|Outcome|Renu MultiPlus®|Used Renu MultiPlus®
525447|NCT00789529|O1|Outcome|Opti-Free® RepleniSH® MPDS|Used Opti-Free® RepleniSH® MPDS
525448|NCT00789529|O2|Outcome|Renu MultiPlus®|Used Renu MultiPlus®
525449|NCT00789529|O1|Outcome|Opti-Free® RepleniSH® MPDS|Used Opti-Free® RepleniSH® MPDS
525450|NCT00789529|E2|Reported Event|2 - Opti-Free RepleniSH First|Opti-Free RepleniSH first, ReNu MultiPlus Second
525451|NCT00789529|E1|Reported Event|1 - ReNu MultiPlus First|Used ReNu MultiPlus first, Opti-Free RepleniSH Second
525452|NCT00789555|B4|Baseline|Total|Total of all reporting groups
525453|NCT00789555|B3|Baseline|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
525454|NCT00789555|B2|Baseline|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
525455|NCT00789555|B1|Baseline|PATANASE|Two sprays in each nostril twice a day for up to 12 months
525456|NCT00789555|P3|Participant Flow|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
525457|NCT00789555|P2|Participant Flow|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
525458|NCT00789555|P1|Participant Flow|PATANASE|Two sprays in each nostril twice a day for up to 12 months
525459|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
525460|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
525461|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
525462|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
525463|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
525464|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
525465|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
525466|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
525467|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
525468|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
525469|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
525470|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
525471|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
525472|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
525473|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
525474|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
525475|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
525476|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
525477|NCT00789555|E3|Reported Event|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
525478|NCT00789555|E2|Reported Event|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
525479|NCT00789555|E1|Reported Event|PATANASE|Two sprays in each nostril twice a day for up to 12 months
525480|NCT00789581|B3|Baseline|Total|Total of all reporting groups
525481|NCT00789581|B2|Baseline|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel weekly for 12 weeks.
Doxorubicin: 60 mg/m2
Cyclophosphamide: 600 mg/m2
Paclitaxel (Taxol): 80 mg/m2"
525482|NCT00789581|B1|Baseline|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.
Doxorubicin: 60 mg/m2
Cyclophosphamide: 600 mg/m2
Ixabepilone (Ixempra): 40 mg/m2"
525483|NCT00789581|P2|Participant Flow|AC/Paclitaxel|"Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by weekly paclitaxel for 12 weeks.
Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Paclitaxel (Taxol): 80 mg/m2"
525484|NCT00789581|P1|Participant Flow|AC/Ixabepilone|"Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by ixabepilone every 3 weeks for 4 cycles (12 weeks).
Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Ixabepilone (Ixempra): 40 mg/m2"
525485|NCT00789581|O2|Outcome|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel weekly for 12 weeks.
Doxorubicin: 60 mg/m2
Cyclophosphamide: 600 mg/m2
Paclitaxel (Taxol): 80 mg/m2"
525486|NCT00789581|O1|Outcome|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.
Doxorubicin: 60 mg/m2
Cyclophosphamide: 600 mg/m2
Ixabepilone (Ixempra): 40 mg/m2"
525487|NCT00789581|O2|Outcome|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.
Doxorubicin: 60 mg/m2
Cyclophosphamide: 600 mg/m2
Paclitaxel (Taxol): 80 mg/m2"
525488|NCT00789581|O1|Outcome|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.
Doxorubicin: 60 mg/m2
Cyclophosphamide: 600 mg/m2
Ixabepilone (Ixempra): 40 mg/m2"
525489|NCT00789581|E2|Reported Event|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.
Doxorubicin: 60 mg/m2
Cyclophosphamide: 600 mg/m2
Paclitaxel (Taxol): 80 mg/m2"
525490|NCT00789581|E1|Reported Event|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.
Doxorubicin: 60 mg/m2
Cyclophosphamide: 600 mg/m2
Ixabepilone (Ixempra): 40 mg/m2"
525491|NCT00789672|B3|Baseline|Total|Total of all reporting groups
525492|NCT00789672|B2|Baseline|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525493|NCT00789672|B1|Baseline|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525494|NCT00789672|P2|Participant Flow|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525495|NCT00789672|P1|Participant Flow|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525496|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525497|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525498|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525499|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525500|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525501|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525502|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525503|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525504|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525505|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525506|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525507|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525508|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525509|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525510|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525511|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525512|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525513|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525514|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525515|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525555|NCT00789724|P1|Participant Flow|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
525516|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525517|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525518|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525519|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525520|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525521|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525522|NCT00789672|E2|Reported Event|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525523|NCT00789672|E1|Reported Event|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
525524|NCT00789685|B1|Baseline|Safety Population|Safety population includes all patients who received at least one dose of study medication, and was used for summaries of demographic and other baseline characteristics
525525|NCT00789685|P1|Participant Flow|Interferon Beta|"Interferon Beta
Interferon Beta administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU or 6.0 MIU (dose escalation phase) or 2.7 MIU (dose expansion phase) were administered."
525526|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
525527|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
525528|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
525529|NCT00789685|E1|Reported Event|Safety Population|Safety population includes all patients who received at least one dose of study medication
525530|NCT00789698|B5|Baseline|Total|Total of all reporting groups
525531|NCT00789698|B4|Baseline|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
525532|NCT00789698|B3|Baseline|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
525533|NCT00789698|B2|Baseline|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
525534|NCT00789698|B1|Baseline|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
525535|NCT00789698|P4|Participant Flow|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
525536|NCT00789698|P3|Participant Flow|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
525537|NCT00789698|P2|Participant Flow|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
525538|NCT00789698|P1|Participant Flow|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
525539|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
525540|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
525541|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
525542|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
525543|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
525544|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or Lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
525545|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
525546|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
525547|NCT00789698|E4|Reported Event|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
525548|NCT00789698|E3|Reported Event|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
525549|NCT00789698|E2|Reported Event|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
525550|NCT00789698|E1|Reported Event|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
525551|NCT00789724|B3|Baseline|Total|Total of all reporting groups
525552|NCT00789724|B2|Baseline|Placebo|0.67 ml of NaCl 0.9% solution
525553|NCT00789724|B1|Baseline|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
525554|NCT00789724|P2|Participant Flow|Placebo|0.67 ml of NaCl 0.9% solution
525559|NCT00789724|E1|Reported Event|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
525560|NCT00789737|B3|Baseline|Total|Total of all reporting groups
525561|NCT00789737|B2|Baseline|Placebo|"placebo
Placebo : placebo"
525562|NCT00789737|B1|Baseline|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525563|NCT00789737|P2|Participant Flow|Placebo|"placebo
Placebo : placebo"
525564|NCT00789737|P1|Participant Flow|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525565|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525566|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525567|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525568|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525569|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525570|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525571|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525572|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525573|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525574|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525575|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525576|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525577|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525578|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525579|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525580|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525581|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525582|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525583|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525584|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525585|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525586|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525587|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525588|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525589|NCT00789737|O2|Outcome|Placebo|"placebo
Placebo : placebo"
525590|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525591|NCT00789737|E2|Reported Event|Placebo|"placebo
Placebo : placebo"
525592|NCT00789737|E1|Reported Event|Welchol|"Welchol 625mg tablets
Welchol : Welchol 625mg tablets"
525593|NCT00789750|B3|Baseline|Total|Total of all reporting groups
525594|NCT00789750|B2|Baseline|Placebo|Placebo tablets with pioglitazone therapy
525595|NCT00789750|B1|Baseline|Colesevelam|Colesevelam tablets with pioglitazone therapy
525596|NCT00789750|P2|Participant Flow|Placebo|Placebo tablets with pioglitazone therapy
525597|NCT00789750|P1|Participant Flow|Colesevelam|Colesevelam tablets with pioglitazone therapy
525598|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525599|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525600|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525601|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525602|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525603|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525604|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525605|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525606|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525607|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525608|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525609|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525610|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525611|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525612|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525613|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525614|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525615|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525616|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525617|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525618|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525619|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525620|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525621|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525622|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525623|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525624|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525625|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525626|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525627|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525628|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525629|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525630|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525631|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525634|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
525635|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
525636|NCT00789750|E2|Reported Event|Placebo|Placebo tablets with pioglitazone therapy
525637|NCT00789750|E1|Reported Event|Colesevelam|Colesevelam tablets with pioglitazone therapy
525638|NCT00789802|B4|Baseline|Total|Total of all reporting groups
525639|NCT00789802|B3|Baseline|Transdermal Estradiol|"participants will be randomized to transdermal estradiol
transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
525640|NCT00789802|B2|Baseline|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
525641|NCT00789802|B1|Baseline|Oral Naproxen|"participants will be randomized to oral naproxen
naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
525642|NCT00789802|P3|Participant Flow|Transdermal Estradiol|"participants will be randomized to transdermal estradiol
transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
525643|NCT00789802|P2|Participant Flow|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
525644|NCT00789802|P1|Participant Flow|Oral Naproxen|"participants will be randomized to oral naproxen
naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
525645|NCT00789802|O3|Outcome|Transdermal Estradiol|"participants will be randomized to transdermal estradiol
transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
525646|NCT00789802|O2|Outcome|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
525647|NCT00789802|O1|Outcome|Oral Naproxen|"participants will be randomized to oral naproxen
naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
525648|NCT00789802|E3|Reported Event|Transdermal Estradiol|"participants will be randomized to transdermal estradiol
transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
525649|NCT00789802|E2|Reported Event|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
525650|NCT00789802|E1|Reported Event|Oral Naproxen|"participants will be randomized to oral naproxen
naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
525651|NCT00789815|B3|Baseline|Total|Total of all reporting groups
525652|NCT00789815|B2|Baseline|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
525653|NCT00789815|B1|Baseline|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
525654|NCT00789815|P2|Participant Flow|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
525655|NCT00789815|P1|Participant Flow|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
525656|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
525657|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
525658|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
525659|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
525660|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
525661|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
525662|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
525688|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
537370|NCT00821041|O2|Outcome|Cognitive Behavioral Therapy|
525893|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525663|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
525664|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
525665|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
525666|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
525667|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
525668|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
525669|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
525670|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
525671|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
525672|NCT00789815|E2|Reported Event|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
525673|NCT00789815|E1|Reported Event|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
525674|NCT00789828|B3|Baseline|Total|Total of all reporting groups
525675|NCT00789828|B2|Baseline|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
525676|NCT00789828|B1|Baseline|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525677|NCT00789828|P2|Participant Flow|Placebo|Participants received oral dose of placebo matching to everolimus daily.
525678|NCT00789828|P1|Participant Flow|Everolimus|Participants received oral dose of everolimus 4.5 milligram/square meter (mg/m^2) daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 nanogram/millilitre (ng/mL). Dose adjustments were permitted based on safety and whole blood trough concentrations.
525679|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
525680|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525681|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
525682|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525683|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
525684|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525685|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
525686|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525687|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
537371|NCT00821041|O1|Outcome|Waiting List Control|
525689|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525690|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
525691|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
525692|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525693|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
525694|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525695|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
525696|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525697|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
525698|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
525699|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525700|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
525701|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
525702|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525703|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
525704|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
525705|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
525706|NCT00789828|E3|Reported Event|Placebo Treated (Core Period)|Participants who received placebo in core period.
525707|NCT00789828|E2|Reported Event|Placebo (Core) Then Everolimus Treated (Extension Period)|Participants who received placebo in core period and then received evrolimus treatment in extension period.
525708|NCT00789828|E1|Reported Event|Everolimus Treated (Core and Extension Period)|Participants who received everolimus treatment in core period and continued to receive evrolimus treatment in extension period.
525709|NCT00789854|B4|Baseline|Total|Total of all reporting groups
525710|NCT00789854|B3|Baseline|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525711|NCT00789854|B2|Baseline|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525712|NCT00789854|B1|Baseline|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525713|NCT00789854|P3|Participant Flow|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525714|NCT00789854|P2|Participant Flow|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525715|NCT00789854|P1|Participant Flow|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525716|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525717|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525718|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525719|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525720|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525721|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525722|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525723|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525724|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525725|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525726|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525727|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525728|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525729|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525730|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525731|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525732|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525733|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525734|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525735|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525736|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525737|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525738|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525739|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525740|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525741|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525742|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525743|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525744|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525745|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525746|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525747|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525748|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525749|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525750|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525751|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525752|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525753|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525754|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525755|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525756|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525757|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525758|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525889|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525759|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525760|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525761|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525762|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525763|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525764|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525765|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525766|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525767|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525768|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525769|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525770|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525771|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525772|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525773|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525774|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525775|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525776|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525777|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525778|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525779|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525780|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525781|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525782|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525783|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525784|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525785|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525786|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525787|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525788|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525789|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525790|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525791|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525792|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525793|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525794|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525890|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525795|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525796|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525797|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525798|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525799|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525800|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525801|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525802|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525803|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525804|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525805|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525806|NCT00789854|E3|Reported Event|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
525807|NCT00789854|E2|Reported Event|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
525808|NCT00789854|E1|Reported Event|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
525809|NCT00789880|B7|Baseline|Total|Total of all reporting groups
525810|NCT00789880|B6|Baseline|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
525811|NCT00789880|B5|Baseline|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
525812|NCT00789880|B4|Baseline|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
525813|NCT00789880|B3|Baseline|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525814|NCT00789880|B2|Baseline|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525815|NCT00789880|B1|Baseline|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
525816|NCT00789880|P6|Participant Flow|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
525817|NCT00789880|P5|Participant Flow|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
525818|NCT00789880|P4|Participant Flow|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
525819|NCT00789880|P3|Participant Flow|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525820|NCT00789880|P2|Participant Flow|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525821|NCT00789880|P1|Participant Flow|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
525822|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
525823|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525824|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
525825|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
525826|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
525827|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525891|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525892|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525828|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
525829|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525830|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
525831|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
525832|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
525833|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525834|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
525835|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525836|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
525837|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
525838|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
525839|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525840|NCT00789880|E6|Reported Event|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
525841|NCT00789880|E5|Reported Event|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
525842|NCT00789880|E4|Reported Event|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
525843|NCT00789880|E3|Reported Event|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525844|NCT00789880|E2|Reported Event|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
525845|NCT00789880|E1|Reported Event|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
525846|NCT00789958|B1|Baseline|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
525847|NCT00789958|P1|Participant Flow|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
525848|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
525849|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
525850|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
525851|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
525852|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
525853|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
525854|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
525855|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
525856|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
525857|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
525858|NCT00789958|E1|Reported Event|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
525859|NCT00789997|B3|Baseline|Total|Total of all reporting groups
525860|NCT00789997|B2|Baseline|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
525861|NCT00789997|B1|Baseline|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
525862|NCT00789997|P2|Participant Flow|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
525863|NCT00789997|P1|Participant Flow|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
525864|NCT00789997|O2|Outcome|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
525865|NCT00789997|O1|Outcome|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
525866|NCT00789997|O2|Outcome|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
525867|NCT00789997|O1|Outcome|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
525868|NCT00789997|E2|Reported Event|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
525869|NCT00789997|E1|Reported Event|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
525870|NCT00790023|B4|Baseline|Total|Total of all reporting groups
525871|NCT00790023|B3|Baseline|Placebo|Placebo once daily
525872|NCT00790023|B2|Baseline|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525873|NCT00790023|B1|Baseline|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525874|NCT00790023|P3|Participant Flow|Placebo|Placebo once daily
525875|NCT00790023|P2|Participant Flow|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525876|NCT00790023|P1|Participant Flow|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525877|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525878|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525879|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525880|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525881|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525882|NCT00790023|O3|Outcome|Placebo|
525883|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525884|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525885|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525886|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525887|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525888|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525895|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525896|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525897|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525898|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525899|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525900|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525901|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525902|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525903|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525904|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525905|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525906|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525907|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525908|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525909|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525910|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525911|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525912|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525913|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525914|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525915|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525916|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525917|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525918|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525919|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525920|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525921|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525922|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525923|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525924|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525925|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525926|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525927|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525928|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525929|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525930|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525931|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525932|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525933|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525934|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525935|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525936|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525937|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525938|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525939|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525940|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525941|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525942|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525943|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525944|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525945|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525946|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525947|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525948|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525949|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525950|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525951|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525952|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525953|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525954|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525955|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525956|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525957|NCT00790023|O3|Outcome|Placebo|Placebo once daily
525958|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525959|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525960|NCT00790023|E3|Reported Event|Placebo|Placebo once daily
525961|NCT00790023|E2|Reported Event|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
525962|NCT00790023|E1|Reported Event|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
525963|NCT00790036|B3|Baseline|Total|Total of all reporting groups
525964|NCT00790036|B2|Baseline|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
525965|NCT00790036|B1|Baseline|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
525966|NCT00790036|P2|Participant Flow|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
525967|NCT00790036|P1|Participant Flow|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
525968|NCT00790036|O2|Outcome|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
525969|NCT00790036|O1|Outcome|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
525970|NCT00790036|O2|Outcome|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
526081|NCT00790218|O1|Outcome|CF102 1mg|CF102 tablets given orally, BID
525971|NCT00790036|O1|Outcome|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
525972|NCT00790036|O2|Outcome|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
525973|NCT00790036|O1|Outcome|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
525974|NCT00790036|E3|Reported Event|All Patients|All Patients in the Everolimus and Placebo groups.
525975|NCT00790036|E2|Reported Event|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
525976|NCT00790036|E1|Reported Event|RAD001 (Everolimus)|RAD001 10 mg (two 5 mg tablets), daily for 12 months
525977|NCT00790062|B4|Baseline|Total|Total of all reporting groups
525978|NCT00790062|B3|Baseline|Oxytocin 80U/500cc|
525979|NCT00790062|B2|Baseline|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
525980|NCT00790062|B1|Baseline|Oxytocin 10 Units/500cc|
525981|NCT00790062|P3|Participant Flow|Oxytocin 80U/500cc|
525982|NCT00790062|P2|Participant Flow|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
525983|NCT00790062|P1|Participant Flow|Oxytocin 10 Units/500cc|
525984|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|"1 dose only given over 1 hour
Oxytocin: See arms"
525985|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
Oxytocin: See arms"
525986|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|"1 dose only for prophylaxis given over 1 hour
Oxytocin: See arms"
525987|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
525988|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
525989|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
525990|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
525991|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
525992|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
525993|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
525994|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
525995|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
525996|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
525997|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
525998|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
525999|NCT00790062|O3|Outcome|Oxytocin 80U/500cc Over 1 Hour|
526000|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc Over 1 Hour|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
526001|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc Over 1 Hour|
526002|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|"1 dose only given over 1 hour
Oxytocin: See arms"
526003|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
Oxytocin: See arms"
526004|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|"1 dose only for prophylaxis given over 1 hour
Oxytocin: See arms"
526005|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|1 dose only for prophylaxsis given over 1 hour
526006|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1 dose only for prophylaxsis given over 1 hour"
526007|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|1 dose only for prophylaxsis given over 1 hour
526008|NCT00790062|E3|Reported Event|Oxytocin 80U/500cc|
526009|NCT00790062|E2|Reported Event|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
526010|NCT00790062|E1|Reported Event|Oxytocin 10 Units/500cc|
526011|NCT00790192|B5|Baseline|Total|Total of all reporting groups
526012|NCT00790192|B4|Baseline|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
526013|NCT00790192|B3|Baseline|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
526014|NCT00790192|B2|Baseline|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
526015|NCT00790192|B1|Baseline|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
526016|NCT00790192|P4|Participant Flow|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
526017|NCT00790192|P3|Participant Flow|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
526018|NCT00790192|P2|Participant Flow|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
526019|NCT00790192|P1|Participant Flow|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
526020|NCT00790192|O4|Outcome|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
526021|NCT00790192|O3|Outcome|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
526022|NCT00790192|O2|Outcome|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
526023|NCT00790192|O1|Outcome|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
526024|NCT00790192|O4|Outcome|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
526025|NCT00790192|O3|Outcome|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
526026|NCT00790192|O2|Outcome|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
526027|NCT00790192|O1|Outcome|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
526028|NCT00790192|E4|Reported Event|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
537372|NCT00821041|O2|Outcome|Cognitive Behavioral Therapy|
526029|NCT00790192|E3|Reported Event|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
526030|NCT00790192|E2|Reported Event|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
526031|NCT00790192|E1|Reported Event|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
526032|NCT00790205|B3|Baseline|Total|Total of all reporting groups
526033|NCT00790205|B2|Baseline|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526034|NCT00790205|B1|Baseline|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526035|NCT00790205|P2|Participant Flow|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526036|NCT00790205|P1|Participant Flow|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526037|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526038|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526039|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526040|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526041|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526042|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526043|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526044|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526045|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526046|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526047|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526048|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526049|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526050|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526051|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526052|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526053|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526054|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526055|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526056|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526057|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526058|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526059|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526060|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526061|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526062|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526063|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526064|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526065|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526066|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526067|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526068|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526069|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526070|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526071|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526072|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526073|NCT00790205|E2|Reported Event|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
526074|NCT00790205|E1|Reported Event|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
526075|NCT00790218|B1|Baseline|CF102|CF102: CF102 capsules twice daily by mouth
526076|NCT00790218|P3|Participant Flow|CF102 25mg|CF102: CF102 tablets were given orally twice daily
526077|NCT00790218|P2|Participant Flow|CF102 5mg|CF102: CF102 tablets were given orally twice daily
526078|NCT00790218|P1|Participant Flow|CF102 1mg|CF102: CF102 tablets were given orally twice daily
526079|NCT00790218|O3|Outcome|CF102 25mg|CF102 tablets given orally, BID
526080|NCT00790218|O2|Outcome|CF102 5mg|CF102 tablets given orally, BID
526082|NCT00790218|E3|Reported Event|CF102 25mg|CF102: CF102 capsules twice daily by mouth
526083|NCT00790218|E2|Reported Event|CF102 5mg|CF102: CF102 capsules twice daily by mouth
526084|NCT00790218|E1|Reported Event|CF102 1mg|CF102: CF102 capsules twice daily by mouth
526085|NCT00790270|B4|Baseline|Total|Total of all reporting groups
526086|NCT00790270|B3|Baseline|Ibuprophen Plus Cyclobenzaprine|
526087|NCT00790270|B2|Baseline|Ibuprofen|
526088|NCT00790270|B1|Baseline|Cyclobenzaprine|
526089|NCT00790270|P3|Participant Flow|Ibuprophen Plus Cyclobenzaprine|
526090|NCT00790270|P2|Participant Flow|Ibuprofen|
526091|NCT00790270|P1|Participant Flow|Cyclobenzaprine|
526092|NCT00790270|O3|Outcome|Ibuprophen Plus Cyclobenzaprine|
526093|NCT00790270|O2|Outcome|Ibuprofen|
526094|NCT00790270|O1|Outcome|Cyclobenzaprine|
526095|NCT00790270|O3|Outcome|Ibuprophen Plus Cyclobenzaprine|
526096|NCT00790270|O2|Outcome|Ibuprofen|
526097|NCT00790270|O1|Outcome|Cyclobenzaprine|
526098|NCT00790270|E3|Reported Event|Ibuprophen Plus Cyclobenzaprine|
526099|NCT00790270|E2|Reported Event|Ibuprofen|
526100|NCT00790270|E1|Reported Event|Cyclobenzaprine|
526101|NCT00790296|B3|Baseline|Total|Total of all reporting groups
526102|NCT00790296|B2|Baseline|Saline Then TRH|Saline given first followed by TRH (0.5 mg)
526103|NCT00790296|B1|Baseline|TRH Then Saline|TRH (0.5mg) given first followed by Saline
526104|NCT00790296|P2|Participant Flow|Saline Then TRH|Saline given first followed by TRH (0.5 mg)
526105|NCT00790296|P1|Participant Flow|TRH Then Saline|TRH (0.5mg) given first followed by Saline
526106|NCT00790296|O2|Outcome|Saline|Saline given Intravenously
526107|NCT00790296|O1|Outcome|Thyrotropin-releasing Hormone (TRH)|TRH given as 0.5mg and 1.5mg intravenously
526108|NCT00790296|E2|Reported Event|Saline|Saline given intravenously
526109|NCT00790296|E1|Reported Event|Thyrotropin-releasing Hormone (TRH)|TRH given as 0.5mg and 1.5mg intravenously
526110|NCT00790400|B3|Baseline|Total|Total of all reporting groups
526111|NCT00790400|B2|Baseline|Placebo|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
526112|NCT00790400|B1|Baseline|Everolimus|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526113|NCT00790400|P2|Participant Flow|Placebo|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
526114|NCT00790400|P1|Participant Flow|Everolimus|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526115|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
526116|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526117|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
526118|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526119|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
526120|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526121|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526122|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526123|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
526124|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526125|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
526126|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
526127|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526128|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
526129|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
526130|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526131|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
526132|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
526133|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526134|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
526135|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
526136|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
526137|NCT00790400|E3|Reported Event|Placebo Randomized/Never Crossed-over|Patients randomized to placebo who never crossed-over to Everolimus
526138|NCT00790400|E2|Reported Event|Placebo Randomized/Crossed Over to Everolimus|Patients who were randomized to placebo in the Core phase and who crossed-over to Everolimus in the Extension phase
526202|NCT00790673|P2|Participant Flow|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid
CF 102: Oral capsules"
526139|NCT00790400|E1|Reported Event|Everolimus Randomized (Core & Ext)|Patients who were randomized and treated with Everolimus during the Core and Extension phase
526140|NCT00790452|B3|Baseline|Total|Total of all reporting groups
526141|NCT00790452|B2|Baseline|Group 2 (Placebo)|Tablet/day orally
526142|NCT00790452|B1|Baseline|Group 1 (Aspirin)|Aspirin 325 mg/day orally
526143|NCT00790452|P2|Participant Flow|Group 2 (Placebo)|Tablet/day orally
526144|NCT00790452|P1|Participant Flow|Group 1 (Aspirin)|Aspirin 325 mg/day orally
526145|NCT00790452|O2|Outcome|Group 2 (Placebo)|Tablet/day orally
526146|NCT00790452|O1|Outcome|Group 1 (Aspirin)|Aspirin 325 mg/day orally
526147|NCT00790452|E2|Reported Event|Group 2 (Placebo)|Tablet/day orally
526148|NCT00790452|E1|Reported Event|Group 1 (Aspirin)|Aspirin 325 mg/day orally
526149|NCT00790556|B1|Baseline|All Participants|All participants
526150|NCT00790556|P2|Participant Flow|Placebo Then MK8245|"During Treatment Period 1, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.
During Treatment Period 2, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14."
526151|NCT00790556|P1|Participant Flow|MK8245 Then Placebo|"During Treatment Period 1, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.
During Treatment Period 2, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14."
526152|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.
Includes results of this treatment from both treatment periods."
526153|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.
Includes results of this treatment from both treatment periods."
526154|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.
Includes results of this treatment from both treatment periods."
526155|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.
Includes results of this treatment from both treatment periods."
526156|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.
Includes results of this treatment from both treatment periods."
526157|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.
Includes results of this treatment from both treatment periods."
526158|NCT00790556|E2|Reported Event|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.
Includes results of this treatment from both treatment periods."
526159|NCT00790556|E1|Reported Event|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.
Includes results of this treatment from both treatment periods."
526160|NCT00790569|B4|Baseline|Total|Total of all reporting groups
526161|NCT00790569|B3|Baseline|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally"
526162|NCT00790569|B2|Baseline|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally"
526163|NCT00790569|B1|Baseline|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally"
526164|NCT00790569|P3|Participant Flow|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally"
526165|NCT00790569|P2|Participant Flow|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally"
526166|NCT00790569|P1|Participant Flow|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally"
526167|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally"
526168|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally"
526169|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally"
526170|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally"
526171|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally"
526172|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally"
526173|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally"
526201|NCT00790673|P3|Participant Flow|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks
CF 102: Oral capsules"
526174|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally"
526175|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally"
526176|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally"
526177|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally"
526178|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally"
526179|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally"
526180|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally"
526181|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally"
526182|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally"
526183|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally"
526184|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally"
526185|NCT00790569|E3|Reported Event|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally"
526186|NCT00790569|E2|Reported Event|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally"
526187|NCT00790569|E1|Reported Event|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally"
526188|NCT00790647|B1|Baseline|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC
bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4
melphalan: 100 mg/m2/dose D –2, D –1
Stem Cell Infusion: infusion of previously collected autologous stem cells"
526189|NCT00790647|P1|Participant Flow|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC
bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4
melphalan: 100 mg/m2/dose D –2, D –1
Stem Cell Infusion: infusion of previously collected autologous stem cells"
526190|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection
bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4
melphalan: 100 mg/m2/dose D –2, D –1
Stem Cell Infusion: infusion of previously collected autologous stem cells"
526191|NCT00790647|O1|Outcome|Stem Cell Transplantation With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection
bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4
melphalan: 100 mg/m2/dose D –2, D –1
Stem Cell Infusion: infusion of previously collected autologous stem cells"
526192|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection
bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4
melphalan: 100 mg/m2/dose D –2, D –1
Stem Cell Infusion: infusion of previously collected autologous stem cells"
526193|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection
bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4
melphalan: 100 mg/m2/dose D –2, D –1
Stem Cell Infusion: infusion of previously collected autologous stem cells"
526194|NCT00790647|E1|Reported Event|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion
filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC
bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4
melphalan: 100 mg/m2/dose D –2, D –1
Stem Cell Infusion: infusion of previously collected autologous stem cells"
526195|NCT00790673|B5|Baseline|Total|Total of all reporting groups
526196|NCT00790673|B4|Baseline|Placebo|Placebo: Matching placebo capsules
526197|NCT00790673|B3|Baseline|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks
CF 102: Oral capsules"
526198|NCT00790673|B2|Baseline|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid
CF 102: Oral capsules"
526199|NCT00790673|B1|Baseline|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd
CF 102: Oral capsules"
526200|NCT00790673|P4|Participant Flow|Placebo|Placebo: Matching placebo capsules
526203|NCT00790673|P1|Participant Flow|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd
CF 102: Oral capsules"
526204|NCT00790673|O4|Outcome|Placebo|Placebo: Matching placebo capsules
526205|NCT00790673|O3|Outcome|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks
CF 102: Oral capsules"
526206|NCT00790673|O2|Outcome|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid
CF 102: Oral capsules"
526207|NCT00790673|O1|Outcome|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd
CF 102: Oral capsules"
526208|NCT00790673|E4|Reported Event|Placebo|Placebo: Matching placebo capsules
526209|NCT00790673|E3|Reported Event|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks
CF 102: Oral capsules"
526210|NCT00790673|E2|Reported Event|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid
CF 102: Oral capsules"
526211|NCT00790673|E1|Reported Event|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd
CF 102: Oral capsules"
526212|NCT00791258|B1|Baseline|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526213|NCT00791258|P1|Participant Flow|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526214|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526215|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526216|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526217|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526218|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526219|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526220|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526221|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526222|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526223|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526224|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526225|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526226|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526227|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526228|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526229|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526230|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526231|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526232|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526233|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526234|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526235|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
537373|NCT00821041|O1|Outcome|Waiting List Control|
526571|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
526236|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526237|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526238|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526239|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526240|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526241|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526242|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526243|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526244|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526245|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526246|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526247|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526248|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526249|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526250|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526251|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526252|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526253|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526254|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526255|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526256|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526257|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526258|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526259|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526260|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526261|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526262|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526263|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526568|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
526264|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526265|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526266|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526267|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526268|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526269|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526270|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526271|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526272|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526273|NCT00791258|E1|Reported Event|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
526274|NCT00791323|B3|Baseline|Total|Total of all reporting groups
526275|NCT00791323|B2|Baseline|Soothe® XP|Mineral Oil Emollient
526276|NCT00791323|B1|Baseline|Ketorolac 0.4%|Ketorolac 0.4%
526277|NCT00791323|P2|Participant Flow|Soothe® XP|Mineral Oil Emollient
526278|NCT00791323|P1|Participant Flow|Ketorolac 0.4%|Ketorolac 0.4%
526279|NCT00791323|O2|Outcome|Soothe® XP|Mineral Oil Emollient
526280|NCT00791323|O1|Outcome|Ketorolac 0.4%|Ketorolac 0.4%
526281|NCT00791323|E2|Reported Event|Soothe® XP|Mineral Oil Emollient
526282|NCT00791323|E1|Reported Event|Ketorolac 0.4%|Ketorolac 0.4%
526283|NCT00791336|B1|Baseline|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
526284|NCT00791336|P1|Participant Flow|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
526285|NCT00791336|O1|Outcome|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
526286|NCT00791336|O1|Outcome|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
526287|NCT00791336|O1|Outcome|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
526288|NCT00791336|E1|Reported Event|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
526289|NCT00791388|B6|Baseline|Total|Total of all reporting groups
526290|NCT00791388|B5|Baseline|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
526291|NCT00791388|B4|Baseline|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
526292|NCT00791388|B3|Baseline|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
526293|NCT00791388|B2|Baseline|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
526294|NCT00791388|B1|Baseline|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
526295|NCT00791388|P5|Participant Flow|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
526296|NCT00791388|P4|Participant Flow|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
526297|NCT00791388|P3|Participant Flow|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
526298|NCT00791388|P2|Participant Flow|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
526299|NCT00791388|P1|Participant Flow|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
526300|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
526569|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
526301|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
526302|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
526303|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
526304|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
526305|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
526306|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
526307|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
526308|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
526309|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
526310|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
526311|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
526312|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
526313|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
526314|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
526315|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
526316|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
526317|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
526318|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
526319|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
526320|NCT00791388|E5|Reported Event|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
526321|NCT00791388|E4|Reported Event|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
526322|NCT00791388|E3|Reported Event|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
526323|NCT00791388|E2|Reported Event|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
526324|NCT00791388|E1|Reported Event|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
526325|NCT00791479|B7|Baseline|Total|Total of all reporting groups
526326|NCT00791479|B6|Baseline|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526327|NCT00791479|B5|Baseline|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526328|NCT00791479|B4|Baseline|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526329|NCT00791479|B3|Baseline|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526330|NCT00791479|B2|Baseline|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526331|NCT00791479|B1|Baseline|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526332|NCT00791479|P6|Participant Flow|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526333|NCT00791479|P5|Participant Flow|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526334|NCT00791479|P4|Participant Flow|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526335|NCT00791479|P3|Participant Flow|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526336|NCT00791479|P2|Participant Flow|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526337|NCT00791479|P1|Participant Flow|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526338|NCT00791479|O5|Outcome|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526339|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526340|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526341|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526342|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526343|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526344|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526345|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526346|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526347|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526348|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526349|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526350|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526351|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526352|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526353|NCT00791479|O6|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526354|NCT00791479|O5|Outcome|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526355|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526356|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526357|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526358|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526359|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526360|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526361|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526362|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526363|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526364|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526365|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526366|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526367|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
537374|NCT00821041|E2|Reported Event|Cognitive Behavioral Therapy|
526368|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526369|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526370|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526371|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526372|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526373|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526374|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526375|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526376|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526377|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526378|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526379|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526380|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526381|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526382|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526383|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526384|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526385|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526386|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526387|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526388|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526389|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526390|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526391|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526392|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526393|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526394|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526395|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526396|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526397|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526398|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526399|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526400|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526401|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526402|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526403|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526404|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526405|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526406|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526407|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526408|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526409|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526410|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526411|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526412|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526413|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
526414|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526415|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526416|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526417|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526418|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526419|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
526420|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
526421|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
526422|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
526423|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
526424|NCT00791479|E6|Reported Event|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526425|NCT00791479|E5|Reported Event|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526426|NCT00791479|E4|Reported Event|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526427|NCT00791479|E3|Reported Event|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526428|NCT00791479|E2|Reported Event|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526429|NCT00791479|E1|Reported Event|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
526430|NCT00791492|B3|Baseline|Total|Total of all reporting groups
526431|NCT00791492|B2|Baseline|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526432|NCT00791492|B1|Baseline|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526433|NCT00791492|P2|Participant Flow|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526434|NCT00791492|P1|Participant Flow|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526435|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526436|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526437|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526438|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526439|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526440|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526441|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526442|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526443|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526444|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526445|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526446|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526447|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526448|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526449|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526450|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526451|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526452|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526453|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526454|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526455|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526456|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526457|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526458|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526459|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526460|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526461|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526462|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526463|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526464|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526465|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526466|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526467|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526468|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526469|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526470|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526471|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526472|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526473|NCT00791492|E2|Reported Event|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526474|NCT00791492|E1|Reported Event|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
526475|NCT00791518|B1|Baseline|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
526476|NCT00791518|P1|Participant Flow|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
526477|NCT00791518|O4|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
526478|NCT00791518|O3|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
526479|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
526480|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and a an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
526481|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
526482|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
526483|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
526484|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
526485|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
526486|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
526487|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
526488|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
526489|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 >=50%
526490|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 <50%
526570|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
526491|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
526492|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <80%
526493|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
526494|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <50%
526495|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
526496|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <80%
526497|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
526498|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
526499|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
526500|NCT00791518|E1|Reported Event|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
526501|NCT00791557|B1|Baseline|Infliximab|"Single arm open label
Infliximab : IV drug given at weeks 1,2,14,22"
526502|NCT00791557|P1|Participant Flow|Infliximab|"Single arm open label
Infliximab : IV drug given at weeks 1,2,14,22"
526503|NCT00791557|O1|Outcome|Infliximab|"Single arm open label
Infliximab : IV drug given at weeks 1,2,14,22"
526504|NCT00791557|E1|Reported Event|Infliximab|"Single arm open label
Infliximab : IV drug given at weeks 1,2,14,22"
526505|NCT00791648|B3|Baseline|Total|Total of all reporting groups
526506|NCT00791648|B2|Baseline|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1."
526507|NCT00791648|B1|Baseline|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
526508|NCT00791648|P2|Participant Flow|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1."
526509|NCT00791648|P1|Participant Flow|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
526510|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1."
526511|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
526512|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1."
526513|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
526514|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1."
526515|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
526516|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1."
526517|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
526518|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1."
526519|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
526520|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1."
526521|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
526522|NCT00791648|E2|Reported Event|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1."
526523|NCT00791648|E1|Reported Event|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
526524|NCT00791661|B4|Baseline|Total|Total of all reporting groups
526525|NCT00791661|B3|Baseline|Panel C: MK-1006 100/140/170|Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
526526|NCT00791661|B2|Baseline|Panel B: MK-1006 60/80/60 Fed|Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
526527|NCT00791661|B1|Baseline|Panel A: MK-1006 15/30/45|Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
526528|NCT00791661|P3|Participant Flow|Panel C: MK-1006 100/140/170|Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
526529|NCT00791661|P2|Participant Flow|Panel B: MK-1006 60/80/60 Fed|Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
526530|NCT00791661|P1|Participant Flow|Panel A: MK-1006 15/30/45|Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
526531|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
526532|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
526533|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
526534|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
526535|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
526536|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
526537|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
526538|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
526539|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
526540|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
526541|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
526542|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
526543|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
526544|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
526545|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
526546|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
526547|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
526548|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
526549|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
526550|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
526551|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
526552|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
526553|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
526554|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
526555|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
526556|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
526557|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
526558|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
526559|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
526560|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
526561|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
526562|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
526563|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
526564|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
526565|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
526566|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
526567|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
526572|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
526573|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
526574|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
526575|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
526576|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
526577|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
526578|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
526579|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
526580|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
526581|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
526582|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
526583|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
526584|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
526585|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
526586|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
526587|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
526588|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
526589|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
526590|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
526591|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
526592|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
526593|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
526594|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
526595|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
526596|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
526597|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
526598|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
526599|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
526600|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
526601|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
526602|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
526603|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
526604|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
526605|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
526606|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
526607|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
526608|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
526609|NCT00791661|E11|Reported Event|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
526610|NCT00791661|E10|Reported Event|Placebo|Participants received matching placebo to MK-1006
526611|NCT00791661|E9|Reported Event|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
526612|NCT00791661|E8|Reported Event|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
526613|NCT00791661|E7|Reported Event|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
526614|NCT00791661|E6|Reported Event|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
526615|NCT00791661|E5|Reported Event|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
526616|NCT00791661|E4|Reported Event|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
526617|NCT00791661|E3|Reported Event|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
526618|NCT00791661|E2|Reported Event|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
526619|NCT00791661|E1|Reported Event|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
526620|NCT00791700|B5|Baseline|Total|Total of all reporting groups
526621|NCT00791700|B4|Baseline|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526622|NCT00791700|B3|Baseline|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526623|NCT00791700|B2|Baseline|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526624|NCT00791700|B1|Baseline|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
526625|NCT00791700|P4|Participant Flow|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526626|NCT00791700|P3|Participant Flow|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526627|NCT00791700|P2|Participant Flow|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526628|NCT00791700|P1|Participant Flow|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
526629|NCT00791700|O3|Outcome|Other Failure/Remainder|Participants with other failures
526630|NCT00791700|O2|Outcome|PDVF|Participants who meet the protocol-defined virologic failure
526631|NCT00791700|O1|Outcome|Response|Participants with plasma HIV-1 RNA <48 copies/mL
526632|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526633|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526634|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526635|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526636|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526637|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526638|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526639|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526640|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526641|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526642|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526643|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526644|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526645|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526646|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526647|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526648|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526649|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526650|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526651|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526652|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526653|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526654|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526655|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526656|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526657|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526658|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526659|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526660|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526661|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526662|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526663|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526664|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526665|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526666|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526667|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526668|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526669|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526670|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526671|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526672|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526673|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526674|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526675|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526676|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526677|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526678|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526679|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526680|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526681|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526682|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526683|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526684|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526685|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526686|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526687|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526688|NCT00791700|O8|Outcome|Cohort 4 (Grade 4)|>=12 - <18 years of age, MVC tablet formulation
526689|NCT00791700|O7|Outcome|Cohort 4 (Grade 3)|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526690|NCT00791700|O6|Outcome|Cohort 3 (Grade 4)|>=6- <12years of age, MVC liquid formulation
526691|NCT00791700|O5|Outcome|Cohort 3 (Grade 3)|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526692|NCT00791700|O4|Outcome|Cohort 2 (Grade 4)|>=6 - <12 years of age, MVC tablet formulation
526693|NCT00791700|O3|Outcome|Cohort 2 (Grade 3)|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526694|NCT00791700|O2|Outcome|Cohort 1 (Grade 4)|>=2 - <6 years of age, MVC liquid formulation
526695|NCT00791700|O1|Outcome|Cohort 1 (Grade 3)|>=2 - <6 years of age, MVC liquid formulation
526696|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526697|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526698|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526699|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526700|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526701|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526702|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526703|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526704|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526705|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526706|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526707|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
526708|NCT00791700|E4|Reported Event|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
526709|NCT00791700|E3|Reported Event|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
526710|NCT00791700|E2|Reported Event|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
526711|NCT00791700|E1|Reported Event|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
526712|NCT00791765|B3|Baseline|Total|Total of all reporting groups
526713|NCT00791765|B2|Baseline|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
526714|NCT00791765|B1|Baseline|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
526715|NCT00791765|P2|Participant Flow|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
526716|NCT00791765|P1|Participant Flow|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
526717|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
526718|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
526719|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
526720|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
526721|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
526770|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526771|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526871|NCT00792259|B3|Baseline|Glaucoma Subjects|Glaucoma subjects presented with pathology
526722|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
526723|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
526724|NCT00791765|E2|Reported Event|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
526725|NCT00791765|E1|Reported Event|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
526726|NCT00791778|B3|Baseline|Total|Total of all reporting groups
526727|NCT00791778|B2|Baseline|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526728|NCT00791778|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526729|NCT00791778|P2|Participant Flow|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526730|NCT00791778|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526731|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526732|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526733|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526734|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526735|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526736|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526737|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526738|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526739|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526740|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526741|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526742|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526743|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526744|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526745|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526746|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526747|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526748|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526749|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526750|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526751|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526752|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526753|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526754|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526755|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526756|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526757|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526758|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526759|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526760|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526761|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526762|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526763|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526764|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526765|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526766|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526767|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526768|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526769|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526859|NCT00792116|B1|Baseline|Gum Chewing|
526772|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526773|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526774|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526775|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526776|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526777|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526778|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526779|NCT00791778|E2|Reported Event|Placebo|Participants received 2 matching placebo tablets per oral twice daily
526780|NCT00791778|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
526781|NCT00791817|B3|Baseline|Total|Total of all reporting groups
526782|NCT00791817|B2|Baseline|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
526783|NCT00791817|B1|Baseline|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
526784|NCT00791817|P2|Participant Flow|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
526785|NCT00791817|P1|Participant Flow|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
526786|NCT00791817|O2|Outcome|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
526787|NCT00791817|O1|Outcome|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
526788|NCT00791817|E2|Reported Event|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
526789|NCT00791817|E1|Reported Event|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
526790|NCT00791908|B1|Baseline|Subjects|
526791|NCT00791908|P1|Participant Flow|Subjects|
526792|NCT00791908|O3|Outcome|Pulsed-dye Laser (PDL)|Laser treatment applied to a third of the torso at each study visit.
526793|NCT00791908|O2|Outcome|KTP Laser|Laser treatment applied to a third of the torso at each study visit.
526794|NCT00791908|O1|Outcome|Electrodesiccation (ED)|Laser treatment applied to a third of the torso at each study visit.
526795|NCT00791908|E3|Reported Event|Pulsed-dye Laser (PDL)|Laser treatment applied to a third of the torso at each study visit.
526796|NCT00791908|E2|Reported Event|KTP Laser|Laser treatment applied to a third of the torso at each study visit.
526797|NCT00791908|E1|Reported Event|Electrodesiccation (ED)|Laser treatment applied to a third of the torso at each study visit.
526798|NCT00791921|B3|Baseline|Total|Total of all reporting groups
526799|NCT00791921|B2|Baseline|Placebo|Placebo of CDP870
526800|NCT00791921|B1|Baseline|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
526801|NCT00791921|P2|Participant Flow|Placebo|Placebo of CDP870
526802|NCT00791921|P1|Participant Flow|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
526803|NCT00791921|O2|Outcome|Placebo|Placebo of CDP870
526804|NCT00791921|O1|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
526805|NCT00791921|O2|Outcome|Placebo|Placebo of CDP870
526806|NCT00791921|O1|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
526807|NCT00791921|E2|Reported Event|Placebo|Placebo of CDP870
526808|NCT00791921|E1|Reported Event|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
526809|NCT00791934|B1|Baseline|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
526810|NCT00791934|P1|Participant Flow|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days.
526811|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
526812|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
526813|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
526814|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
526815|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
526816|NCT00791934|E1|Reported Event|Stratus Microflow Ethmoid Spacer|Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
526817|NCT00791973|B3|Baseline|Total|Total of all reporting groups
526818|NCT00791973|B2|Baseline|Placebo, Then Veramyst|placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
526819|NCT00791973|B1|Baseline|Veramyst, Then Placbeo|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week
526820|NCT00791973|P2|Participant Flow|Placebo, Then Veramyst|placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
526821|NCT00791973|P1|Participant Flow|Veramyst, Then Placebo|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week
526822|NCT00791973|O2|Outcome|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
526823|NCT00791973|O1|Outcome|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
526824|NCT00791973|O2|Outcome|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
526825|NCT00791973|O1|Outcome|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
526826|NCT00791973|E2|Reported Event|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
526827|NCT00791973|E1|Reported Event|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
526828|NCT00791999|B5|Baseline|Total|Total of all reporting groups
526829|NCT00791999|B4|Baseline|Placebo|Placebo given every 2 weeks
526830|NCT00791999|B3|Baseline|CDP870 400mg|400mg CDP870 given every 2 weeks
526831|NCT00791999|B2|Baseline|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
526832|NCT00791999|B1|Baseline|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
526833|NCT00791999|P4|Participant Flow|Placebo|Placebo given every 2 weeks
526834|NCT00791999|P3|Participant Flow|CDP870 400mg|400mg CDP870 given every 2 weeks
526835|NCT00791999|P2|Participant Flow|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
526836|NCT00791999|P1|Participant Flow|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
526837|NCT00791999|O4|Outcome|Placebo|Placebo given every 2 weeks
526838|NCT00791999|O3|Outcome|CDP870 400mg|400mg CDP870 given every 2 weeks
526839|NCT00791999|O2|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
526840|NCT00791999|O1|Outcome|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
526841|NCT00791999|O4|Outcome|Placebo|Placebo given every 2 weeks
526842|NCT00791999|O3|Outcome|CDP870 400mg|400mg CDP870 given every 2 weeks
526843|NCT00791999|O2|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
526844|NCT00791999|O1|Outcome|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
526845|NCT00791999|E4|Reported Event|Placebo|Placebo given every 2 weeks
526846|NCT00791999|E3|Reported Event|CDP870 400mg|400mg CDP870 given every 2 weeks
526847|NCT00791999|E2|Reported Event|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
526848|NCT00791999|E1|Reported Event|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
526849|NCT00792103|B1|Baseline|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
526850|NCT00792103|P1|Participant Flow|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
526851|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
526852|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
526853|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
526854|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
526855|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
526856|NCT00792103|E1|Reported Event|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
526857|NCT00792116|B3|Baseline|Total|Total of all reporting groups
526858|NCT00792116|B2|Baseline|Non-Gum Chewing|
526872|NCT00792259|B2|Baseline|Retinal Disease Subjects|Retinal Disease subjects with ocular pathology
526873|NCT00792259|B1|Baseline|Normal Subjects|Normal Subjects with no known ocular pathology
526874|NCT00792259|P3|Participant Flow|Glaucoma Subjects|Subjects presented with Glaucoma
526875|NCT00792259|P2|Participant Flow|Normal Subjects|Normal subjects with no known ocular pathology
526876|NCT00792259|P1|Participant Flow|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
526877|NCT00792259|O3|Outcome|Glaucoma Subjects|Subjects presented with glaucoma
526878|NCT00792259|O2|Outcome|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
526879|NCT00792259|O1|Outcome|Normal Subjects|Normal subjects with no known ocular pathology
526880|NCT00792259|E3|Reported Event|Glaucoma Subjects|Subjects presented with glaucoma
526881|NCT00792259|E2|Reported Event|Normal Subjects|Normal subjects with no known ocular pathology
526882|NCT00792259|E1|Reported Event|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
526883|NCT00792298|B1|Baseline|All Treated Participants|All randomized participants who received at least one dose of study treatment.
526884|NCT00792298|P8|Participant Flow|Placebo → Suvorexant 80 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2.
526885|NCT00792298|P7|Participant Flow|Suvorexant 80 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
526886|NCT00792298|P6|Participant Flow|Placebo → Suvorexant 40 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2.
526887|NCT00792298|P5|Participant Flow|Suvorexant 40 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
526888|NCT00792298|P4|Participant Flow|Placebo → Suvorexant 20 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2.
526889|NCT00792298|P3|Participant Flow|Suvorexant 20 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
526890|NCT00792298|P2|Participant Flow|Placebo → Suvorexant 10 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2.
526891|NCT00792298|P1|Participant Flow|Suvorexant 10 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
526892|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
526893|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
526894|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
526895|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
526896|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
526897|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526898|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526899|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526900|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526901|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
526902|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526903|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526904|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526905|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526906|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
526907|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526908|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526909|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
528287|NCT00802672|E2|Reported Event|Reference Product|Loprox® (ciclopirox) Cream 0.77%
526910|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526911|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
526912|NCT00792298|E5|Reported Event|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526913|NCT00792298|E4|Reported Event|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526914|NCT00792298|E3|Reported Event|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526915|NCT00792298|E2|Reported Event|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
526916|NCT00792298|E1|Reported Event|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
526917|NCT00792428|B3|Baseline|Total|Total of all reporting groups
526918|NCT00792428|B2|Baseline|Sham-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.
Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue."
526919|NCT00792428|B1|Baseline|Real-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.
Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue"
526920|NCT00792428|P2|Participant Flow|Sham-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.
Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue."
526921|NCT00792428|P1|Participant Flow|Real-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.
Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue"
526922|NCT00792428|O2|Outcome|Sham-tDCS + PT-OT|Subjects are receiving sham tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
526923|NCT00792428|O1|Outcome|Real-tDCS + PT-OT|Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
526924|NCT00792428|O2|Outcome|Sham-tDCS + PT-OT|Subjects are receiving sham tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
526925|NCT00792428|O1|Outcome|Real-tDCS + PT-OT|Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
526926|NCT00792428|E2|Reported Event|Sham tDCS + PT-OT|Subjects are receiving sham tDCS in a dual configuration over both motor regions for 30 minutes while they are also receiving PT-OT for 60 minutes
526927|NCT00792428|E1|Reported Event|Real-tDCS + PT-OT|Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
526928|NCT00792610|B1|Baseline|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
526929|NCT00792610|P1|Participant Flow|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
526930|NCT00792610|O1|Outcome|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
526931|NCT00792610|E1|Reported Event|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
526932|NCT00792623|B1|Baseline|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526933|NCT00792623|P1|Participant Flow|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526934|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526935|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526936|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526937|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526938|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526939|NCT00792623|O1|Outcome|Varilrix Arm|
526940|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526941|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526942|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526943|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526944|NCT00792623|E1|Reported Event|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
526945|NCT00792636|B4|Baseline|Total|Total of all reporting groups
526946|NCT00792636|B3|Baseline|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526947|NCT00792636|B2|Baseline|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
526948|NCT00792636|B1|Baseline|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526949|NCT00792636|P3|Participant Flow|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526950|NCT00792636|P2|Participant Flow|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
526951|NCT00792636|P1|Participant Flow|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526952|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526953|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
526954|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526955|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526956|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
526957|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526958|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526959|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
526960|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526961|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526962|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
526963|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526964|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526965|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
526966|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526967|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526968|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
526969|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526970|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526971|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
526972|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526973|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526974|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526975|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526976|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526977|NCT00792636|O2|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526978|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526979|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
526980|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526981|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526982|NCT00792636|O2|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526983|NCT00792636|O1|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
526984|NCT00792636|E3|Reported Event|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
526985|NCT00792636|E2|Reported Event|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
527234|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
526986|NCT00792636|E1|Reported Event|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
526987|NCT00792688|B4|Baseline|Total|Total of all reporting groups
526988|NCT00792688|B3|Baseline|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
526989|NCT00792688|B2|Baseline|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
526990|NCT00792688|B1|Baseline|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
526991|NCT00792688|P3|Participant Flow|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
526992|NCT00792688|P2|Participant Flow|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
526993|NCT00792688|P1|Participant Flow|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
526994|NCT00792688|O3|Outcome|All Treatments Placebo|
526995|NCT00792688|O2|Outcome|All Treatments GLYC-101 Gel, 1.0%|
526996|NCT00792688|O1|Outcome|All Treatments GLYC-101 Gel, 0.1%|
526997|NCT00792688|O3|Outcome|All Treatments Placebo|
526998|NCT00792688|O2|Outcome|All Treatments GLYC-101 Gel, 1.0%|
526999|NCT00792688|O1|Outcome|All Treatments GLYC-101 Gel, 0.1%|
527000|NCT00792688|E3|Reported Event|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
527001|NCT00792688|E2|Reported Event|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
527002|NCT00792688|E1|Reported Event|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
527003|NCT00792701|B3|Baseline|Total|Total of all reporting groups
527004|NCT00792701|B2|Baseline|Gemcitabine Hydrochloride and Cisplatin|"Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Gemcitabine Hydrochloride: Given IV"
527005|NCT00792701|B1|Baseline|Active Monitoring|"Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks.
Active surveillance: Patients undergo active monitoring"
527006|NCT00792701|P2|Participant Flow|Gemcitabine Hydrochloride and Cisplatin|"Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Gemcitabine Hydrochloride: Given IV"
527007|NCT00792701|P1|Participant Flow|Active Monitoring|"Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks.
Active surveillance: Patients undergo active monitoring"
527008|NCT00792701|O1|Outcome|All Patients|All registered patients.
527009|NCT00792701|O1|Outcome|All Patients|All registered patients.
527010|NCT00792701|O1|Outcome|All Patients|All registered patients.
527011|NCT00792701|O1|Outcome|All Patients|All registered patients.
527012|NCT00792701|O1|Outcome|Gemcitabine Hydrochloride and Cisplatin|Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
527013|NCT00792701|O2|Outcome|Gemcitabine Hydrochloride and Cisplatin|"Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Gemcitabine Hydrochloride: Given IV"
527014|NCT00792701|O1|Outcome|Active Monitoring|"Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks.
Active surveillance: Patients undergo active monitoring"
527015|NCT00792701|O1|Outcome|All Eligible Patients|All patients who received a treatment assignment within the prespecified timeframe.
527016|NCT00792701|E1|Reported Event|Gemcitabine Hydrochloride and Cisplatin|Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
527017|NCT00792805|B4|Baseline|Total|Total of all reporting groups
527018|NCT00792805|B3|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527019|NCT00792805|B2|Baseline|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527020|NCT00792805|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527021|NCT00792805|P3|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527022|NCT00792805|P2|Participant Flow|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527023|NCT00792805|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527024|NCT00792805|O3|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527025|NCT00792805|O2|Outcome|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527026|NCT00792805|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527027|NCT00792805|E3|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527028|NCT00792805|E2|Reported Event|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527029|NCT00792805|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
527030|NCT00792922|B5|Baseline|Total|Total of all reporting groups
527031|NCT00792922|B4|Baseline|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%
In Niger, treatment will be every 6-months for children ages twelve and under.
Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
527032|NCT00792922|B3|Baseline|≥90% Coverage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%
In Niger, treatment will be every 6-months for children ages twelve and under.
Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
527033|NCT00792922|B2|Baseline|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate"
527034|NCT00792922|B1|Baseline|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate"
527035|NCT00792922|P4|Participant Flow|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%
In Niger, treatment will be every 6-months for children ages twelve and under.
Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
527036|NCT00792922|P3|Participant Flow|≥90% Coverage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%
In Niger, treatment will be every 6-months for children ages twelve and under.
Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
527037|NCT00792922|P2|Participant Flow|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate"
527083|NCT00793325|B1|Baseline|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
527038|NCT00792922|P1|Participant Flow|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate"
527039|NCT00792922|O4|Outcome|80%-89% Coverage With Azithromycin: Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%
In Niger, treatment will be every 6-months for children ages twelve and under.
Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
527040|NCT00792922|O3|Outcome|≥90% Coveage With Azithromycin, Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%
In Niger, treatment will be every 6-months for children ages twelve and under.
Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
527041|NCT00792922|O2|Outcome|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate"
527042|NCT00792922|O1|Outcome|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate"
527043|NCT00792922|O4|Outcome|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%
In Niger, treatment will be every 6-months for children ages twelve and under.
Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
527044|NCT00792922|O3|Outcome|≥90% Coveage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%
In Niger, treatment will be every 6-months for children ages twelve and under.
Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
527045|NCT00792922|O2|Outcome|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate"
527046|NCT00792922|O1|Outcome|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate"
527047|NCT00792922|E4|Reported Event|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%
In Niger, treatment will be every 6-months for children ages twelve and under.
Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
527048|NCT00792922|E3|Reported Event|≥90% Coverage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%
In Niger, treatment will be every 6-months for children ages twelve and under.
Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
527049|NCT00792922|E2|Reported Event|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate"
527050|NCT00792922|E1|Reported Event|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate"
527051|NCT00792935|B3|Baseline|Total|Total of all reporting groups
527052|NCT00792935|B2|Baseline|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
527053|NCT00792935|B1|Baseline|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
527054|NCT00792935|P2|Participant Flow|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
527055|NCT00792935|P1|Participant Flow|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
527056|NCT00792935|O2|Outcome|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
527057|NCT00792935|O1|Outcome|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
527058|NCT00792935|O2|Outcome|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
527059|NCT00792935|O1|Outcome|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
527060|NCT00792935|E2|Reported Event|Glimepiride|All patients as treated (APaT) defined as all randomized participants who received at least one dose of glimepiride.
527061|NCT00792935|E1|Reported Event|MK-0941|All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941.
527062|NCT00792948|B1|Baseline|Treatment|
527063|NCT00792948|P1|Participant Flow|Treatment|"See Detailed Description
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dasatinib: Given PO
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Methotrexate: Given IV or IT
Methylprednisolone: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Prednisone: Given PO
Sirolimus: Given PO
Tacrolimus: Given IV
Total-Body Irradiation: Undergo TBI
Vincristine Sulfate: Given IV"
527064|NCT00792948|O1|Outcome|Treatment|"See Detailed Description
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dasatinib: Given PO
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Methotrexate: Given IV or IT
Methylprednisolone: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Prednisone: Given PO
Sirolimus: Given PO
Tacrolimus: Given IV
Total-Body Irradiation: Undergo TBI
Vincristine Sulfate: Given IV"
527065|NCT00792948|O1|Outcome|Treatment|"See Detailed Description
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dasatinib: Given PO
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Methotrexate: Given IV or IT
Methylprednisolone: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Prednisone: Given PO
Sirolimus: Given PO
Tacrolimus: Given IV
Total-Body Irradiation: Undergo TBI
Vincristine Sulfate: Given IV"
527066|NCT00792948|O1|Outcome|Treatment|"See Detailed Description
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dasatinib: Given PO
Dexamethasone: Given IV or PO
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Methotrexate: Given IV or IT
Methylprednisolone: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant
Prednisone: Given PO
Sirolimus: Given PO
Tacrolimus: Given IV
Total-Body Irradiation: Undergo TBI
Vincristine Sulfate: Given IV"
527067|NCT00792948|E4|Reported Event|Dasatinib|Patients receive Single-Agent Dasatinib therapy PO every day for up to five years from original registration.
527068|NCT00792948|E3|Reported Event|Allogeneic Stem Cell Transplant|Patients who have an available sibling donor or a 10/10 matched unrelated donor will be removed from therapy and proceed directly to allogeneic stem cell transplant after achieving CR or CRi.
527069|NCT00792948|E2|Reported Event|Vincristine/Prednisone/Dasatinib|Patients receive vincristine IV on day 1, prednisone PO on days 1 to 5, and dasatinib PO on days 1 to 28 for up to 24 courses or until transplant is available.
527070|NCT00792948|E1|Reported Event|Induction/Consolidation|Patients receive up to 8 courses, alternating between hyper-CVAD plus dasatinib and high dose methotrexate and cytarabine plus dasatinib. There are nine possible induction/consolidation courses.
527071|NCT00793104|B1|Baseline|CR Plug|Placement of allograft CR Plug in primary injury site
527072|NCT00793104|P1|Participant Flow|CR Plug|Placement of allograft CR Plug in primary injury site
527073|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
527074|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
527075|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
527076|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
527077|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
527078|NCT00793104|E1|Reported Event|CR Plug|Placement of allograft CR Plug in primary injury site
527079|NCT00793169|B1|Baseline|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
527080|NCT00793169|P1|Participant Flow|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
527081|NCT00793169|O1|Outcome|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
527082|NCT00793169|E1|Reported Event|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
527235|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
527084|NCT00793325|P1|Participant Flow|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
527085|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants whose change in the height SD scores was measured at one, two, and three years of taking somatropin for small-for-gestational age according to Japanese package insert.
527086|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants whose change in the growth rate SD scores was measured at one, two, and three years of taking somatropin for small-for-gestational age according to Japanese package insert.
527087|NCT00793325|O2|Outcome|Participants Without Concomitant Drug(s)|Participants taking no concomitant drugs while taking somatropin for SGA according to Japanese package insert.
527088|NCT00793325|O1|Outcome|Participants With Concomitant Drug(s)|Participants taking concomitant drug(s) while taking somatropin for SGA according to Japanese package insert.
527089|NCT00793325|O2|Outcome|Participants Without Renal Impairment|Participants without renal impairment taking somatropin for SGA according to Japanese package insert.
527090|NCT00793325|O1|Outcome|Participants With Renal Impairment|Participants with renal impairment taking somatropin for SGA according to Japanese package insert.
527091|NCT00793325|O2|Outcome|Participants Without Hepatic Function Disorder|Participants without hepatic function disorder taking somatropin for SGA according to Japanese package insert.
527092|NCT00793325|O1|Outcome|Participants With Hepatic Function Disorder|Participants with hepatic function disorder taking somatropin for SGA according to Japanese package insert.
527093|NCT00793325|O2|Outcome|Participants Without Complication(s)|Participants without complications while taking somatropin for SGA according to Japanese package insert.
527094|NCT00793325|O1|Outcome|Participants With Complication(s)|Participants with complication(s) while taking somatropin for SGA according to Japanese package insert.
527095|NCT00793325|O2|Outcome|Participants Without Past History of Any Disease|Participants without past history of any disease taking somatropin for SGA according to Japanese package insert.
527096|NCT00793325|O1|Outcome|Participants With Past History of Any Disease|Participants with past history of any disease taking somatropin for SGA according to Japanese package insert.
527097|NCT00793325|O3|Outcome|Severe SGA|Participants with severe SGA taking somatropin for SGA according to Japanese package insert.
527098|NCT00793325|O2|Outcome|Moderate SGA|Participants with moderate SGA taking somatropin for SGA according to Japanese package insert.
527099|NCT00793325|O1|Outcome|Mild SGA|Participants with mild SGA taking somatropin for SGA according to Japanese package insert.
527100|NCT00793325|O2|Outcome|Female|Female Participants taking somatropin for SGA according to Japanese package insert.
527101|NCT00793325|O1|Outcome|Male|Male Participants taking somatropin for SGA according to Japanese package insert.
527102|NCT00793325|O2|Outcome|>=15 Years|Participants 15 years of age or older when taking somatropin for SGA according to Japanese package insert.
527103|NCT00793325|O1|Outcome|<15 Years|Participants younger than 15 years of age when taking somatropin for SGA according to Japanese package insert.
527104|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
527105|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
527106|NCT00793325|E1|Reported Event|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
527107|NCT00793403|B1|Baseline|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527108|NCT00793403|P1|Participant Flow|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527109|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527110|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527111|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527112|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527113|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527114|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527115|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527116|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527117|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527118|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527119|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527120|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527121|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527122|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527123|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527124|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527125|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527126|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527127|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527128|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527129|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527130|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527131|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527132|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527133|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527134|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527135|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527191|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
527136|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527137|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527138|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527139|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527140|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527141|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527142|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527143|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527144|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527145|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527146|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527147|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527148|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527149|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527150|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527151|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527152|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527153|NCT00793403|E1|Reported Event|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
527154|NCT00793455|B3|Baseline|Total|Total of all reporting groups
527155|NCT00793455|B2|Baseline|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
527156|NCT00793455|B1|Baseline|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
527232|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
527157|NCT00793455|P2|Participant Flow|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
527158|NCT00793455|P1|Participant Flow|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
527159|NCT00793455|O2|Outcome|Intervention Group|Received outreach intervention
527160|NCT00793455|O1|Outcome|Usual Care Control Group|Usual Care
527161|NCT00793455|O2|Outcome|Intervention Group|Received Educational Outreach
527162|NCT00793455|O1|Outcome|Usual Care Control Group|Usual Care
527163|NCT00793455|E2|Reported Event|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
527164|NCT00793455|E1|Reported Event|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
527165|NCT00793520|B3|Baseline|Total|Total of all reporting groups
527166|NCT00793520|B2|Baseline|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
527167|NCT00793520|B1|Baseline|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
527168|NCT00793520|P2|Participant Flow|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
527169|NCT00793520|P1|Participant Flow|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
527170|NCT00793520|O2|Outcome|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
527171|NCT00793520|O1|Outcome|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
527172|NCT00793520|O2|Outcome|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
527173|NCT00793520|O1|Outcome|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
527174|NCT00793520|E2|Reported Event|Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
527175|NCT00793520|E1|Reported Event|Milnacipran|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
527176|NCT00793546|B3|Baseline|Total|Total of all reporting groups
527177|NCT00793546|B2|Baseline|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527178|NCT00793546|B1|Baseline|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527179|NCT00793546|P2|Participant Flow|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527180|NCT00793546|P1|Participant Flow|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527181|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
527182|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527183|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
527184|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527185|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
527186|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527187|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
527188|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527189|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
527190|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527192|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527193|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
527194|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527195|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
527196|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527197|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
527198|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527199|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
527200|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527201|NCT00793546|O2|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527202|NCT00793546|O1|Outcome|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527203|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
527204|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527205|NCT00793546|E2|Reported Event|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527206|NCT00793546|E1|Reported Event|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
527207|NCT00793572|B1|Baseline|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation
Bortezomib: Given SC
Cyclosporine: Given IV
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation
Peripheral Blood Stem Cell Transplantation: Undergo transplantation
Syngeneic Bone Marrow Transplantation: Undergo transplantation
Total-Body Irradiation: Undergo radiotherapy"
527208|NCT00793572|P1|Participant Flow|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation
Bortezomib: Given SC
Cyclosporine: Given IV
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation
Peripheral Blood Stem Cell Transplantation: Undergo transplantation
Syngeneic Bone Marrow Transplantation: Undergo transplantation
Total-Body Irradiation: Undergo radiotherapy"
527209|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation
Bortezomib: Given SC
Cyclosporine: Given IV
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation
Peripheral Blood Stem Cell Transplantation: Undergo transplantation
Syngeneic Bone Marrow Transplantation: Undergo transplantation
Total-Body Irradiation: Undergo radiotherapy"
527210|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation
Bortezomib: Given SC
Cyclosporine: Given IV
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation
Peripheral Blood Stem Cell Transplantation: Undergo transplantation
Syngeneic Bone Marrow Transplantation: Undergo transplantation
Total-Body Irradiation: Undergo radiotherapy"
527211|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation
Bortezomib: Given SC
Cyclosporine: Given IV
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation
Peripheral Blood Stem Cell Transplantation: Undergo transplantation
Syngeneic Bone Marrow Transplantation: Undergo transplantation
Total-Body Irradiation: Undergo radiotherapy"
527233|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
537375|NCT00821041|E1|Reported Event|Waiting List Control|
527212|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation
Bortezomib: Given SC
Cyclosporine: Given IV
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation
Peripheral Blood Stem Cell Transplantation: Undergo transplantation
Syngeneic Bone Marrow Transplantation: Undergo transplantation
Total-Body Irradiation: Undergo radiotherapy"
527213|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation
Bortezomib: Given SC
Cyclosporine: Given IV
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation
Peripheral Blood Stem Cell Transplantation: Undergo transplantation
Syngeneic Bone Marrow Transplantation: Undergo transplantation
Total-Body Irradiation: Undergo radiotherapy"
527214|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation
Bortezomib: Given SC
Cyclosporine: Given IV
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation
Peripheral Blood Stem Cell Transplantation: Undergo transplantation
Syngeneic Bone Marrow Transplantation: Undergo transplantation
Total-Body Irradiation: Undergo radiotherapy"
527215|NCT00793572|E1|Reported Event|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation
Bortezomib: Given SC
Cyclosporine: Given IV
Cyclosporine: Given PO
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation
Peripheral Blood Stem Cell Transplantation: Undergo transplantation
Syngeneic Bone Marrow Transplantation: Undergo transplantation
Total-Body Irradiation: Undergo radiotherapy"
527216|NCT00793585|B3|Baseline|Total|Total of all reporting groups
527217|NCT00793585|B2|Baseline|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
527218|NCT00793585|B1|Baseline|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
527219|NCT00793585|P2|Participant Flow|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
527220|NCT00793585|P1|Participant Flow|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
527221|NCT00793585|O2|Outcome|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
527222|NCT00793585|O1|Outcome|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
527223|NCT00793585|O2|Outcome|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
527224|NCT00793585|O1|Outcome|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
527225|NCT00793585|E2|Reported Event|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
527226|NCT00793585|E1|Reported Event|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
527227|NCT00793611|B3|Baseline|Total|Total of all reporting groups
527228|NCT00793611|B2|Baseline|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
527229|NCT00793611|B1|Baseline|Behavioral Therapy Standard Care|received 3 behavioral therapy session
527230|NCT00793611|P2|Participant Flow|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
527231|NCT00793611|P1|Participant Flow|Behavioral Therapy Standard Care|received 3 behavioral therapy session
527236|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
527237|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
527238|NCT00793611|E2|Reported Event|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
527239|NCT00793611|E1|Reported Event|Behavioral Therapy Standard Care|received 3 behavioral therapy session
527240|NCT00793624|B5|Baseline|Total|Total of all reporting groups
527241|NCT00793624|B4|Baseline|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527242|NCT00793624|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527243|NCT00793624|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527244|NCT00793624|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527245|NCT00793624|P4|Participant Flow|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527246|NCT00793624|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527247|NCT00793624|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527248|NCT00793624|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527249|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527250|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527251|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527252|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527253|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527254|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527255|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527256|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527257|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527258|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527259|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527260|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527261|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527262|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527263|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527264|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527265|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527266|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527267|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527268|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527269|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527270|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527271|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527272|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527273|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
527274|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
527275|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
527276|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
527277|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
527278|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
527279|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
527280|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
527281|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
527282|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
527283|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
527284|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
527285|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
527286|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
527287|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
527288|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
527289|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
527348|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527290|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
527291|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
527292|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
527293|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
527294|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
527295|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
527296|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
527297|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527298|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527299|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527300|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527301|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527302|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527303|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527304|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527305|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527306|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527307|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527308|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527309|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527310|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527311|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527312|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527313|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527314|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527315|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527316|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527317|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527318|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527319|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527320|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527321|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527322|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527323|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527324|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527325|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527326|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527327|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527328|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527329|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527330|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527331|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527332|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527333|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527334|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527335|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527336|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527337|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527338|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527339|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527340|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527341|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527342|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527343|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527344|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527345|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527346|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527347|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527349|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527350|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527351|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527352|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527353|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527354|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527355|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527356|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527357|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527358|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527359|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527360|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527361|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527362|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527363|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527364|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527365|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527366|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527367|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527368|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527369|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527370|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527371|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527372|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527373|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527374|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527375|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527376|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527377|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527378|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527379|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527380|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527381|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527382|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527383|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527384|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527385|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527386|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527387|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527388|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527389|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527390|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527391|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527392|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527393|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527394|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527395|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527396|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527397|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527398|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527399|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527400|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527401|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527402|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527403|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527404|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527405|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527406|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527407|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527408|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527409|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527410|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527411|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527412|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527413|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527414|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527415|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527416|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527417|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527418|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527419|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527420|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527421|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527422|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527423|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527424|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527425|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527426|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527427|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527428|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527429|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527430|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527431|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527432|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527433|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527434|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527435|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527436|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527437|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527438|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527439|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527440|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527441|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527442|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527443|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527444|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527445|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527446|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527447|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527448|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527449|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527450|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527451|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527452|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527453|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527454|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527455|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527456|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527457|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527458|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527459|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527460|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527461|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527462|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527463|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527464|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527465|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527466|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527467|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527468|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527469|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527470|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527471|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527472|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527473|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527474|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527475|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527476|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527477|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527478|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527479|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527480|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527481|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527482|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527483|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527484|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527485|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527486|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527487|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527488|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527489|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527490|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527491|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527492|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527493|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527494|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527495|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527496|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527497|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527498|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527499|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527500|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527501|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527502|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527503|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527504|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527505|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527506|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527507|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527508|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527509|NCT00793624|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
527510|NCT00793624|E3|Reported Event|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
527511|NCT00793624|E2|Reported Event|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
527512|NCT00793624|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
527513|NCT00793650|B3|Baseline|Total|Total of all reporting groups
527514|NCT00793650|B2|Baseline|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days
−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
527515|NCT00793650|B1|Baseline|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days
−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
527516|NCT00793650|P2|Participant Flow|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days
−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
527517|NCT00793650|P1|Participant Flow|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days
−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
527518|NCT00793650|O2|Outcome|Bortezomib After Melphalan|"patients received melphalan (100 mg/m^2/day × 2; days
−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
527699|NCT00799708|O3|Outcome|Placebo|Placebo capsule once daily for 7 days.
527700|NCT00799708|O2|Outcome|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
527519|NCT00793650|O1|Outcome|Bortezomib Before Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days
−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
527520|NCT00793650|O2|Outcome|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days
−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
527521|NCT00793650|O1|Outcome|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days
−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
527522|NCT00793650|E2|Reported Event|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days
−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
527523|NCT00793650|E1|Reported Event|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days
−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
527524|NCT00787839|B1|Baseline|Group 1|Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.
527525|NCT00787839|P1|Participant Flow|Group 1|"Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.
Glucose challenge test: At a first outpatient visit, at different times of the day and without a prior fast, subjects will have a 50 gram glucose drink followed by measurement of plasma and capillary glucose along with A1c one hour later. They will also fill out questionnaires. At a second outpatient visit, in the morning after fasting overnight, they will have a 75 gram oral glucose tolerance test.
Glucose tolerance test: Subjects found to have diabetes or prediabetes on the initial glucose tolerance test may be requested to have a repeat glucose tolerance test and A1c."
527526|NCT00787839|O8|Outcome|GCTcap - Dysglycemia - Medicare|Medicare costs per case of dysglycemia identified, using the GCTcap screening test
527527|NCT00787839|O7|Outcome|GCTpl - Dysglycemia - Medicare|Medicare costs per case of dysglycemia identified, using the GCTpl screening test
527528|NCT00787839|O6|Outcome|GCTcap - Diabetes - Medicare|Medicare costs per case of diabetes identified, using the GCTcap screening test
527529|NCT00787839|O5|Outcome|GCTpl - Diabetes - Medicare|Medicare costs per case of diabetes identified, using the GCTpl screening test
527530|NCT00787839|O4|Outcome|GCTcap - Dysglycemia - VA|VA costs per case of dysglycemia identified, using the GCTcap screening test
527531|NCT00787839|O3|Outcome|GCTpl - Dysglycemia - VA|VA costs per case of dysglycemia identified, using the GCTpl screening test
527532|NCT00787839|O2|Outcome|GCTcap - Diabetes - VA|VA costs per case of diabetes identified, using the GCTcap screening test
527533|NCT00787839|O1|Outcome|GCTpl - Diabetes - VA|VA costs per case of diabetes identified, using the GCTpl screening test
527534|NCT00787839|O10|Outcome|A1c - Dysglycemia|hemoglobin A1c, measured at the time of the OGTT
527535|NCT00787839|O9|Outcome|RCG - Dysglycemia|random capillary glucose measured prior to the 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
527536|NCT00787839|O8|Outcome|RPG - Dysglycemia|random plasma glucose measured prior to the 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
527537|NCT00787839|O7|Outcome|GCTcap - Dysglycemia|capillary glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
527538|NCT00787839|O6|Outcome|GCTpl - Dysglycemia|plasma glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
527539|NCT00787839|O5|Outcome|A1c - Diabetes|hemoglobin A1c, measured at the time of the OGTT
527540|NCT00787839|O4|Outcome|RCG - Diabetes|random capillary glucose measured prior to administration of the 50g oral glucose challenge, at any time during the day, without requiring a prior overnight fast
527541|NCT00787839|O3|Outcome|RPG - Diabetes|random plasma glucose measured prior to administration of the 50g oral glucose challenge, at any time during the day, without requiring a prior overnight fast
527542|NCT00787839|O2|Outcome|GCTcap - Diabetes|capillary glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
527543|NCT00787839|O1|Outcome|GCTpl - Diabetes|plasma glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
527544|NCT00787839|E1|Reported Event|Group 1|Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, the American Diabetes Association, and the National Institutes of Health
527545|NCT00787852|B3|Baseline|Total|Total of all reporting groups
527546|NCT00787852|B2|Baseline|Group 2|"Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,
Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily
50 mg daily 100 mg daily
70 mg daily 100 mg daily
100 mg daily 100 mg daily"
527584|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527547|NCT00787852|B1|Baseline|Group 1|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily
50 mg daily 100 mg daily
70 mg daily 100 mg daily
100 mg daily 100 mg daily"
527548|NCT00787852|P2|Participant Flow|Group 2: Dasatinib 70mg|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib & Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43
Dasatinib is to be taken 1x daily 70 mg daily
Maintenance x 2 years*"
527549|NCT00787852|P1|Participant Flow|Group 1: Dasatinib 50mg|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib & Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43
Dasatinib is to be taken 1x daily 50 mg daily
Maintenance x 2 years*"
527550|NCT00787852|O2|Outcome|Group 2|"Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,
Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily
50 mg daily 100 mg daily
70 mg daily 100 mg daily
100 mg daily 100 mg daily"
527551|NCT00787852|O1|Outcome|Group 1|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily
50 mg daily 100 mg daily
70 mg daily 100 mg daily
100 mg daily 100 mg daily"
527552|NCT00787852|E2|Reported Event|Group 2|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily
70 mg daily"
527553|NCT00787852|E1|Reported Event|Group 1|DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily 50 mg daily
527554|NCT00799578|B1|Baseline|Cystagon-EC|
527555|NCT00799578|P1|Participant Flow|Cystagon-EC|
527556|NCT00799578|O1|Outcome|Number of Improved Subjects|
527557|NCT00799578|E1|Reported Event|Number of Improved Subjects|
527558|NCT00799591|B1|Baseline|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
527559|NCT00799591|P1|Participant Flow|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
527560|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
527561|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
527562|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
527563|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
527564|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
527565|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
527566|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
527567|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
527568|NCT00799591|E1|Reported Event|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
527569|NCT00799604|B4|Baseline|Total|Total of all reporting groups
527570|NCT00799604|B3|Baseline|Cohort 3: Clevidipine 125 μg ( mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527571|NCT00799604|B2|Baseline|Cohort 2: Clevidipine 500 μg (1.0 mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which Clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527572|NCT00799604|B1|Baseline|Cohort 1: Clevidipine 250 μg (0.5 mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527573|NCT00799604|P3|Participant Flow|Planned Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5mL Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Three participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 received a Bolus 2 dose of 125 μg during Treatment Period 2 in this cohort.
527574|NCT00799604|P2|Participant Flow|Planned Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Six participants who received a Bolus 1 dose of 500 μg and six participants who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 500 μg during Treatment Period 2 in this cohort.
527575|NCT00799604|P1|Participant Flow|Planned Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Five participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 and one participant who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 250 μg during Treatment Period 2 in this cohort.
527576|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527577|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527578|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527579|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527580|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527581|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527582|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527583|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527701|NCT00799708|O1|Outcome|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
527585|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527586|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527587|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527588|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527589|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527590|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527591|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527592|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527593|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527594|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527595|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527596|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
527597|NCT00799604|E1|Reported Event|All Participants Across All Cohorts and Treatment Periods|Study participants were sequentially assigned one of three cohorts to receive either a 250 μg, 500 μg or 125 μg bolus dose of clevidipine during Treatment Period 1 prior to induction of general anesthesia (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds). At the discretion of the investigator, a second bolus could be administered during Treatment Period 2 after induction of general anesthesia (Bolus 2 - with anesthesia) at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1.
527598|NCT00799617|B3|Baseline|Total|Total of all reporting groups
527599|NCT00799617|B2|Baseline|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527600|NCT00799617|B1|Baseline|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527601|NCT00799617|P2|Participant Flow|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527602|NCT00799617|P1|Participant Flow|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527603|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527604|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527605|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527702|NCT00799708|E3|Reported Event|Placebo|Placebo capsule once daily for 7 days.
527703|NCT00799708|E2|Reported Event|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
527704|NCT00799708|E1|Reported Event|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
527606|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527607|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527608|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527609|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527610|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527611|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527612|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527613|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527614|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527615|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527616|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527617|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527618|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527619|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527620|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527705|NCT00799773|B3|Baseline|Total|Total of all reporting groups
527706|NCT00799773|B2|Baseline|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527621|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527622|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527623|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527624|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527625|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527626|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527627|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527628|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527629|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527630|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527631|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527632|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527633|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527634|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527635|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527651|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527636|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527637|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527638|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527639|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527640|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527641|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527642|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527643|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527644|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527645|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527646|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527647|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527648|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527649|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527650|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527695|NCT00799708|P2|Participant Flow|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
537376|NCT00821093|B3|Baseline|Total|Total of all reporting groups
527652|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527653|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527654|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527655|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527656|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527657|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527658|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527659|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527660|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527661|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527662|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527663|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527664|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527665|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527666|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527696|NCT00799708|P1|Participant Flow|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
527697|NCT00799708|O2|Outcome|Placebo|
527667|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527668|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527669|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527670|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527671|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527672|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527673|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527674|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527675|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527676|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527677|NCT00799617|E2|Reported Event|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.
Placebo: Testosterone levels will be measured at regular intervals."
527678|NCT00799617|E1|Reported Event|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.
AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
527679|NCT00799643|B3|Baseline|Total|Total of all reporting groups
527680|NCT00799643|B2|Baseline|Salsalate|Salsalate, 3.5 g/d orally, divided dosing
527681|NCT00799643|B1|Baseline|Placebo|Placebo for salsalate, orally, divided dosing
527682|NCT00799643|P2|Participant Flow|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
527683|NCT00799643|P1|Participant Flow|Placebo|Placebo for salsalate, orally, divided dosing
527684|NCT00799643|O2|Outcome|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
527685|NCT00799643|O1|Outcome|Placebo|Placebo for salsalate, orally, divided dosing
527686|NCT00799643|O2|Outcome|Salsalate|Salsalate, 3.5 g/d orally, divided dosing
527687|NCT00799643|O1|Outcome|Placebo|Placebo for salsalate, orally, divided dosing
527688|NCT00799643|E2|Reported Event|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
527689|NCT00799643|E1|Reported Event|Placebo|Placebo for salsalate, orally, divided dosing
527690|NCT00799708|B4|Baseline|Total|Total of all reporting groups
527691|NCT00799708|B3|Baseline|Placebo|Placebo capsule once daily for 7 days.
527692|NCT00799708|B2|Baseline|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
527693|NCT00799708|B1|Baseline|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
527694|NCT00799708|P3|Participant Flow|Placebo|Placebo capsule once daily for 7 days.
527698|NCT00799708|O1|Outcome|17β-estradiol 2.0 Milligrams|
527707|NCT00799773|B1|Baseline|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527708|NCT00799773|P2|Participant Flow|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527709|NCT00799773|P1|Participant Flow|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527710|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527711|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527712|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527713|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527714|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527715|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527716|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527717|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527718|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527719|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527720|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527721|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527722|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527723|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527724|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527725|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527726|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527727|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527728|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527729|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527730|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527731|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527732|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527733|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527734|NCT00799773|E2|Reported Event|Standard of Care|Participants will receive plasma exchange and corticosteroids.
527735|NCT00799773|E1|Reported Event|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
527736|NCT00799825|B1|Baseline|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
527737|NCT00799825|P1|Participant Flow|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
527738|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
527739|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
527740|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
527741|NCT00799825|E1|Reported Event|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
527742|NCT00800345|B1|Baseline|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.
Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.
Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
527743|NCT00800345|P1|Participant Flow|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.
Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.
Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
537599|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
527744|NCT00800345|O1|Outcome|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.
Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.
Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
527745|NCT00800345|O1|Outcome|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.
Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.
Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
527746|NCT00800345|E1|Reported Event|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.
Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.
Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
527747|NCT00800384|B3|Baseline|Total|Total of all reporting groups
527748|NCT00800384|B2|Baseline|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
527749|NCT00800384|B1|Baseline|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
527750|NCT00800384|P2|Participant Flow|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
527751|NCT00800384|P1|Participant Flow|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
527752|NCT00800384|O2|Outcome|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and ventricular fibrillation (VF) induction was performed followed by shock delivery to test shock efficacy at implant.
527753|NCT00800384|O1|Outcome|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
527754|NCT00800384|O2|Outcome|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
527755|NCT00800384|O1|Outcome|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
527756|NCT00800384|E2|Reported Event|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
527757|NCT00800384|E1|Reported Event|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
527758|NCT00800436|B8|Baseline|Total|Total of all reporting groups
527759|NCT00800436|B7|Baseline|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
527760|NCT00800436|B6|Baseline|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
527761|NCT00800436|B5|Baseline|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
527762|NCT00800436|B4|Baseline|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
527763|NCT00800436|B3|Baseline|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
527764|NCT00800436|B2|Baseline|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
527765|NCT00800436|B1|Baseline|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
527766|NCT00800436|P7|Participant Flow|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
527767|NCT00800436|P6|Participant Flow|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
527768|NCT00800436|P5|Participant Flow|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
527769|NCT00800436|P4|Participant Flow|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
527770|NCT00800436|P3|Participant Flow|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg subcutaneously (SC) on Day 1.
527771|NCT00800436|P2|Participant Flow|Part 1: Cohort 2|Female participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
527772|NCT00800436|P1|Participant Flow|Part 1: Cohort 1|Healthy male participants received Herceptin 6 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1.
527773|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
527774|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
527775|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
527776|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
527777|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
527778|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
527779|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
528278|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
527780|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
527781|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
527782|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
527783|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
527784|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
527785|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
527786|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
527787|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
527788|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
527789|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
527790|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
527791|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
527792|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
527793|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
527794|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
527795|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
527796|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
527797|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
527798|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
527799|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
527800|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
527801|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
527802|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
527803|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
527804|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
527805|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
527806|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
527807|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
527808|NCT00800436|E7|Reported Event|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
527809|NCT00800436|E6|Reported Event|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
527810|NCT00800436|E5|Reported Event|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
527811|NCT00800436|E4|Reported Event|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
527812|NCT00800436|E3|Reported Event|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
527813|NCT00800436|E2|Reported Event|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
527814|NCT00800436|E1|Reported Event|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
527815|NCT00800540|B1|Baseline|Overall|All enrolled
527816|NCT00800540|P2|Participant Flow|COMBIGAN/AZARGA|COMBIGAN, followed by AZARGA, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
527817|NCT00800540|P1|Participant Flow|AZARGA/COMBIGAN|AZARGA, followed by COMBIGAN, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
527818|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527819|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527820|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527821|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527822|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527823|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527824|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527825|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527826|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527827|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527828|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527829|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527830|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527831|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527832|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527833|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527834|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527835|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527836|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527837|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527838|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527839|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527840|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527841|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527842|NCT00800540|E2|Reported Event|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527843|NCT00800540|E1|Reported Event|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
527844|NCT00800683|B3|Baseline|Total|Total of all reporting groups
527845|NCT00800683|B2|Baseline|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527846|NCT00800683|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
527847|NCT00800683|P2|Participant Flow|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527848|NCT00800683|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
527849|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527850|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527851|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527852|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527853|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527854|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527855|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527856|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527857|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527858|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527859|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527860|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527861|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527862|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527863|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527864|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527865|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527866|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527867|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527868|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527869|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527870|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527871|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527872|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527873|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527874|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527875|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527876|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527877|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527878|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527879|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527880|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527881|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527882|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527883|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527884|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527885|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527886|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527887|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527888|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527889|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
527890|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
527891|NCT00800683|E2|Reported Event|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
528279|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
527892|NCT00800683|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
527893|NCT00800735|B1|Baseline|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
527894|NCT00800735|P1|Participant Flow|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
527895|NCT00800735|O1|Outcome|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
527896|NCT00800735|E1|Reported Event|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
527897|NCT00800839|B1|Baseline|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
527898|NCT00800839|P1|Participant Flow|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
527899|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
527900|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
527901|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
527902|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
527903|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
527904|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
527905|NCT00800839|E1|Reported Event|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
527906|NCT00800865|B3|Baseline|Total|Total of all reporting groups
527907|NCT00800865|B2|Baseline|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
527908|NCT00800865|B1|Baseline|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
527909|NCT00800865|P2|Participant Flow|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
527910|NCT00800865|P1|Participant Flow|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
527911|NCT00800865|O2|Outcome|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
527912|NCT00800865|O1|Outcome|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
528280|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
527913|NCT00800865|O2|Outcome|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
527914|NCT00800865|O1|Outcome|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
527915|NCT00800865|E2|Reported Event|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
527916|NCT00800865|E1|Reported Event|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
527917|NCT00800982|B3|Baseline|Total|Total of all reporting groups
527918|NCT00800982|B2|Baseline|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
527919|NCT00800982|B1|Baseline|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
527920|NCT00800982|P2|Participant Flow|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
In addition, for months 3-6, subjects will receive Narrow Band Ultraviolet B phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. Narrow Band Ultraviolet B therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff."
527921|NCT00800982|P1|Participant Flow|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No Ultraviolet B will be given. Sham Ultraviolet B will not be used because the subjects are not blinded because they often know they are receiving sham Ultraviolet B due to differences in light intensity and heat.
527922|NCT00800982|O2|Outcome|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
527923|NCT00800982|O1|Outcome|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
527924|NCT00800982|E2|Reported Event|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
527925|NCT00800982|E1|Reported Event|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
527926|NCT00801099|B1|Baseline|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
527927|NCT00801099|P1|Participant Flow|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
527928|NCT00801099|O1|Outcome|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
527929|NCT00801099|E1|Reported Event|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
527930|NCT00801138|B5|Baseline|Total|Total of all reporting groups
527931|NCT00801138|B4|Baseline|Group 4|"Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid"
527932|NCT00801138|B3|Baseline|Group 3|"Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid"
527933|NCT00801138|B2|Baseline|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline"
527934|NCT00801138|B1|Baseline|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline"
527935|NCT00801138|P4|Participant Flow|Group 4|"Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid"
528281|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
527936|NCT00801138|P3|Participant Flow|Group 3|"Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid"
527937|NCT00801138|P2|Participant Flow|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline"
527938|NCT00801138|P1|Participant Flow|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline"
527939|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid"
527940|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid"
527941|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline"
527942|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline"
527943|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid"
527944|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid"
527945|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline"
527946|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline"
527947|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid"
527948|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid"
527949|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline"
527950|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline"
527951|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid"
527952|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid"
527953|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline"
527954|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline"
527955|NCT00801138|E4|Reported Event|Group 4|"Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid"
527956|NCT00801138|E3|Reported Event|Group 3|"Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid"
527957|NCT00801138|E2|Reported Event|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline"
527958|NCT00801138|E1|Reported Event|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline"
527959|NCT00801229|B3|Baseline|Total|Total of all reporting groups
527960|NCT00801229|B2|Baseline|Placebo|
527961|NCT00801229|B1|Baseline|Vyvanse|
527962|NCT00801229|P2|Participant Flow|Placebo|
527963|NCT00801229|P1|Participant Flow|Vyvanse|
527964|NCT00801229|O2|Outcome|Placebo|
527965|NCT00801229|O1|Outcome|Vyvanse|
527966|NCT00801229|E2|Reported Event|Placebo|
527967|NCT00801229|E1|Reported Event|Vyvanse|
527968|NCT00801242|B1|Baseline|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
527969|NCT00801242|P1|Participant Flow|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
527970|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
527971|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
527972|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
527973|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
527974|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
527975|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
527976|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
528282|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
527977|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
527978|NCT00801242|E1|Reported Event|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix at a concentration of 40 mg/mL was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix at a concentration of 20 mg/mL were administered 28 days apart via single s.c. injections.
527979|NCT00801632|B1|Baseline|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
527980|NCT00801632|P1|Participant Flow|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
527981|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
527982|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
527983|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
527984|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
527994|NCT00801684|O2|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
528029|NCT00801892|E1|Reported Event|1 Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP
Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
527985|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
527986|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
527987|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
527988|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
527989|NCT00801632|E1|Reported Event|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
527990|NCT00801684|B1|Baseline|Overall Study|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.
The dosing formulations were as follows:
Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate)"
527991|NCT00801684|P1|Participant Flow|Overall Study|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.
The dosing formulations were as follows:
Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate)"
527992|NCT00801684|O4|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
527993|NCT00801684|O3|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
528030|NCT00801983|B3|Baseline|Total|Total of all reporting groups
528283|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
527995|NCT00801684|O1|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
527996|NCT00801684|O5|Outcome|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
527997|NCT00801684|O4|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
527998|NCT00801684|O3|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
527999|NCT00801684|O2|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
528000|NCT00801684|O1|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
528001|NCT00801684|O5|Outcome|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
528002|NCT00801684|O4|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
528003|NCT00801684|O3|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
528004|NCT00801684|O2|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
528005|NCT00801684|O1|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
528006|NCT00801684|E6|Reported Event|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
528007|NCT00801684|E5|Reported Event|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
528028|NCT00801892|E2|Reported Event|2 = Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP
Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
537600|NCT00823043|O1|Outcome|Timolol Hemihydrate|
528008|NCT00801684|E4|Reported Event|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
528009|NCT00801684|E3|Reported Event|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
528010|NCT00801684|E2|Reported Event|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
528011|NCT00801684|E1|Reported Event|Overall Study|
528012|NCT00801801|B1|Baseline|Metronomic Taxotere + Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
528013|NCT00801801|P1|Participant Flow|Metronomic Taxotere and Nexavar|"Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluated after every 8 weeks. Treatment with metronomic chemotherapy and sorafenib will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with sorafenib will then continue until disease progression, intolerable toxicity or withdrawal of consent."
528014|NCT00801801|O1|Outcome|Metronomic Docetaxel + Sorafenib|"Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle."
528015|NCT00801801|O1|Outcome|Metronomic Taxotere + Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
528016|NCT00801801|E1|Reported Event|Metronomic Taxotere and Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
528017|NCT00801827|B1|Baseline|Surgical|Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
528018|NCT00801827|P1|Participant Flow|Surgical|Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
528019|NCT00801827|O1|Outcome|F-18 (Fallypride)|Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.
528020|NCT00801827|E1|Reported Event|F-18 (Fallypride)|"Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.
F-18 (fallypride): Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation."
528021|NCT00801892|B3|Baseline|Total|Total of all reporting groups
528022|NCT00801892|B2|Baseline|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP
Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
528023|NCT00801892|B1|Baseline|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP
Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
528024|NCT00801892|P2|Participant Flow|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP
Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
528025|NCT00801892|P1|Participant Flow|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP
Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
528026|NCT00801892|O2|Outcome|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP
Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
528027|NCT00801892|O1|Outcome|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP
Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
528284|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
528031|NCT00801983|B2|Baseline|Group B|Subject receives alternative keyboard first (0-6 months) and typical keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
528032|NCT00801983|B1|Baseline|Group A|Subject receives typical keyboard first (0-6 months) and alternative keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
528033|NCT00801983|P2|Participant Flow|Group B (Alternative/Typical)|Subject receives alternate keyboard for 5-6 months first and typical keyboard second for 5-6 months (total 12 months in study
528034|NCT00801983|P1|Participant Flow|Group A (Typical/Alternative)|Subject receives typical keyboard for 5-6 months first and alternative keyboard second for 5-6 months (total 12 months in study
528035|NCT00801983|O2|Outcome|Alternative Keyboard|MSD reported when a subject was typing on an alternative keyboard (regardless of order)
528036|NCT00801983|O1|Outcome|Typical Keyboard|MSD reported when a subject was typing on a typical keyboard (regardless of order)
528037|NCT00801983|E2|Reported Event|Alternative Keyboard|MSD reported when a subject was typing on an alternative keyboard (regardless of order)
528038|NCT00801983|E1|Reported Event|Typical Keyboard|MSD reported when a subject was typing on a typical keyboard (regardless of order)
528039|NCT00802074|B7|Baseline|Total|Total of all reporting groups
528040|NCT00802074|B6|Baseline|Group F|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528041|NCT00802074|B5|Baseline|Group E|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528042|NCT00802074|B4|Baseline|Group D|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528043|NCT00802074|B3|Baseline|Group C|"Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528044|NCT00802074|B2|Baseline|Group B|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528045|NCT00802074|B1|Baseline|Group A|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528046|NCT00802074|P6|Participant Flow|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
528047|NCT00802074|P5|Participant Flow|Group E|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
528048|NCT00802074|P4|Participant Flow|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
528049|NCT00802074|P3|Participant Flow|Group C|Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
528050|NCT00802074|P2|Participant Flow|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
528051|NCT00802074|P1|Participant Flow|Group A|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
528052|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
528053|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
528054|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
528055|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
528056|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
528057|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
528058|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
528085|NCT00802100|B1|Baseline|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
528285|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
528059|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
528060|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
528061|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
528062|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
528063|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
528064|NCT00802074|O6|Outcome|Group F|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528065|NCT00802074|O5|Outcome|Group E|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528066|NCT00802074|O4|Outcome|Group D|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528067|NCT00802074|O3|Outcome|Group C|"Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528068|NCT00802074|O2|Outcome|Group B|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528069|NCT00802074|O1|Outcome|Group A|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Raltegravir: 400mg BID
Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
528070|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
528071|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
528072|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
528073|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
528074|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
528075|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
528076|NCT00802074|E6|Reported Event|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
528077|NCT00802074|E5|Reported Event|Group E|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
528078|NCT00802074|E4|Reported Event|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
528079|NCT00802074|E3|Reported Event|Group C|Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
528080|NCT00802074|E2|Reported Event|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
528081|NCT00802074|E1|Reported Event|Group A|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
528082|NCT00802100|B4|Baseline|Total|Total of all reporting groups
528083|NCT00802100|B3|Baseline|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
528084|NCT00802100|B2|Baseline|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
528286|NCT00802672|E3|Reported Event|Vehicle Product|Vehicle
528086|NCT00802100|P3|Participant Flow|Aripiprazole|"Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
Aripiprazole dose 10-30 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day"
528087|NCT00802100|P2|Participant Flow|Perphenazine|"Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
Perphenazine dose 8-24 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day"
528088|NCT00802100|P1|Participant Flow|Olanzapine|"Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
Olanzapine dose 10-30 mg/day Metformin dose 850-2550 mg/day"
528089|NCT00802100|O3|Outcome|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
528090|NCT00802100|O2|Outcome|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
528091|NCT00802100|O1|Outcome|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
528092|NCT00802100|O1|Outcome|Overall Study|This refers to the feasibility of the entire pilot study. Only 21 eligible participants of the goal of 60 were randomized because sites were unable to identify adequate numbers of eligible participants.
528093|NCT00802100|E3|Reported Event|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
528094|NCT00802100|E2|Reported Event|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
528095|NCT00802100|E1|Reported Event|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
528096|NCT00802178|B1|Baseline|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
528097|NCT00802178|P1|Participant Flow|Mirapexin® (Pramipexole)|"The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics.
mode of administration (admin.): Tablets for oral use"
528098|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
528099|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
528100|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
528101|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
528102|NCT00802178|E1|Reported Event|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
528103|NCT00802204|B3|Baseline|Total|Total of all reporting groups
528104|NCT00802204|B2|Baseline|Obese|
528105|NCT00802204|B1|Baseline|Lean|
528106|NCT00802204|P2|Participant Flow|Obese|BMI>/=30kg/m2
528107|NCT00802204|P1|Participant Flow|Lean|BMI<~25kg/m2
528108|NCT00802204|O2|Outcome|Obese|
528109|NCT00802204|O1|Outcome|Lean|
528110|NCT00802204|O3|Outcome|Obese Post-diet|
528111|NCT00802204|O2|Outcome|Obese Baseline|
528112|NCT00802204|O1|Outcome|Lean Baseline|
528113|NCT00802204|O3|Outcome|Obese Post-diet|
528114|NCT00802204|O2|Outcome|Obese Baseline|
528115|NCT00802204|O1|Outcome|Lean Baseline|
528116|NCT00802204|O3|Outcome|Obese Post-diet|
528117|NCT00802204|O2|Outcome|Obese Baseline|
528118|NCT00802204|O1|Outcome|Lean Baseline|
528119|NCT00802204|O3|Outcome|Obese Post-diet|
528120|NCT00802204|O2|Outcome|Obese Baseline|
528121|NCT00802204|O1|Outcome|Lean Baseline|
528122|NCT00802204|O3|Outcome|Obese Post-diet|
528123|NCT00802204|O2|Outcome|Obese Baseline|
528124|NCT00802204|O1|Outcome|Lean Baseline|
528125|NCT00802204|O3|Outcome|Obese Post-diet|
528126|NCT00802204|O2|Outcome|Obese Baseline|
528127|NCT00802204|O1|Outcome|Lean Baseline|
528128|NCT00802204|E2|Reported Event|Obese|
528129|NCT00802204|E1|Reported Event|Lean|
528130|NCT00802360|B5|Baseline|Total|Total of all reporting groups
528131|NCT00802360|B4|Baseline|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528212|NCT00802503|E1|Reported Event|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
528213|NCT00802529|B3|Baseline|Total|Total of all reporting groups
528132|NCT00802360|B3|Baseline|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528133|NCT00802360|B2|Baseline|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528134|NCT00802360|B1|Baseline|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528135|NCT00802360|P4|Participant Flow|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528136|NCT00802360|P3|Participant Flow|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528137|NCT00802360|P2|Participant Flow|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528138|NCT00802360|P1|Participant Flow|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528139|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528140|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528141|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528142|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528143|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528144|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528145|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528214|NCT00802529|B2|Baseline|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
528215|NCT00802529|B1|Baseline|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
528146|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528147|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528148|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528149|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528150|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528151|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528152|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528153|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528154|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528155|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528156|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528157|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528158|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528159|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528216|NCT00802529|P2|Participant Flow|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.Each injection was 40mg/ml.
528217|NCT00802529|P1|Participant Flow|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks. Each injection was 62.5mg/ml.
528160|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528161|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528162|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528163|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
528164|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
528165|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
528166|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
528167|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
528168|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
528169|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
528170|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
528171|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
528172|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
528173|NCT00802360|E4|Reported Event|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528174|NCT00802360|E3|Reported Event|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528218|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
528175|NCT00802360|E2|Reported Event|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528176|NCT00802360|E1|Reported Event|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
528177|NCT00802412|B3|Baseline|Total|Total of all reporting groups
528178|NCT00802412|B2|Baseline|Placebo|Received placebo
528179|NCT00802412|B1|Baseline|Topiramate|Received active topiramate
528180|NCT00802412|P2|Participant Flow|Placebo|"90 participants, will receive matching placebo
Placebo: Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design."
528181|NCT00802412|P1|Participant Flow|Topiramate|"The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.
Topiramate: Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days)."
528182|NCT00802412|O2|Outcome|Placebo|12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
528183|NCT00802412|O1|Outcome|Topiramate|12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
528184|NCT00802412|O2|Outcome|Placebo|12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
528185|NCT00802412|O1|Outcome|Topiramate|12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
528186|NCT00802412|E2|Reported Event|Placebo|
528187|NCT00802412|E1|Reported Event|Topiramate|
528188|NCT00802503|B3|Baseline|Total|Total of all reporting groups
528189|NCT00802503|B2|Baseline|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528190|NCT00802503|B1|Baseline|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
528191|NCT00802503|P2|Participant Flow|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528192|NCT00802503|P1|Participant Flow|Control Group|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
528193|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528194|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
528195|NCT00802503|O2|Outcome|SPN gr|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528196|NCT00802503|O1|Outcome|Controle gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
528219|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
528220|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
528221|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
528197|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528198|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
528199|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528200|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
528201|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528202|NCT00802503|O1|Outcome|Control Group|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
528203|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528204|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
528205|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528206|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
528207|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528208|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
528209|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528210|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
528211|NCT00802503|E2|Reported Event|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
528222|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
528223|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
528224|NCT00802529|E2|Reported Event|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
528225|NCT00802529|E1|Reported Event|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
528226|NCT00802633|B3|Baseline|Total|Total of all reporting groups
528227|NCT00802633|B2|Baseline|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy
Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
528228|NCT00802633|B1|Baseline|Stapling Device|"Efficacy of stapling device during radical cystectomy
Stapling device during radical cystectomy: Hemostasis"
528229|NCT00802633|P2|Participant Flow|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy
Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
528230|NCT00802633|P1|Participant Flow|Stapling Device|"Efficacy of stapling device during radical cystectomy
Stapling device during radical cystectomy: Hemostasis"
528231|NCT00802633|O2|Outcome|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy
Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
528232|NCT00802633|O1|Outcome|Stapling Device|"Efficacy of stapling device during radical cystectomy
Stapling device during radical cystectomy: Hemostasis"
528233|NCT00802633|O2|Outcome|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy
Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
528234|NCT00802633|O1|Outcome|Stapling Device|"Efficacy of stapling device during radical cystectomy
Stapling device during radical cystectomy: Hemostasis"
528235|NCT00802633|E2|Reported Event|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy
Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
528236|NCT00802633|E1|Reported Event|Stapling Device|"Efficacy of stapling device during radical cystectomy
Stapling device during radical cystectomy: Hemostasis"
528237|NCT00802659|B5|Baseline|Total|Total of all reporting groups
528238|NCT00802659|B4|Baseline|Group 3|"1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528239|NCT00802659|B3|Baseline|Group 2|"1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528240|NCT00802659|B2|Baseline|Group 1|"1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528241|NCT00802659|B1|Baseline|Group -1|"1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528242|NCT00802659|P4|Participant Flow|Group 3|"1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528243|NCT00802659|P3|Participant Flow|Group 2|"1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528244|NCT00802659|P2|Participant Flow|Group 1|"1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528245|NCT00802659|P1|Participant Flow|Group -1|"1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528246|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528247|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528248|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528249|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528270|NCT00802672|B4|Baseline|Total|Total of all reporting groups
528250|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528251|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528252|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528253|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528254|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528255|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528256|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528257|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528258|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528259|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528260|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528261|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528262|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528263|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528264|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528265|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528266|NCT00802659|E4|Reported Event|Group 3|"1600 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528267|NCT00802659|E3|Reported Event|Group 2|"1400 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528268|NCT00802659|E2|Reported Event|Group 1|"1200 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528269|NCT00802659|E1|Reported Event|Group -1|"1000 cGY radiation
Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
528288|NCT00802672|E1|Reported Event|Test Product|Ciclopirox Olamine Cream, USP
528289|NCT00802685|B3|Baseline|Total|Total of all reporting groups
528290|NCT00802685|B2|Baseline|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group
IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).
Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
528291|NCT00802685|B1|Baseline|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.
Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
528292|NCT00802685|P2|Participant Flow|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group
IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).
Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
528293|NCT00802685|P1|Participant Flow|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.
Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
528294|NCT00802685|O2|Outcome|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group
IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).
Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
528295|NCT00802685|O1|Outcome|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.
Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
528296|NCT00802685|O2|Outcome|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group
IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).
Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
528366|NCT00790751|B3|Baseline|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
528367|NCT00790751|B2|Baseline|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
572686|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
528297|NCT00802685|O1|Outcome|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.
Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
528298|NCT00802685|E2|Reported Event|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group
IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).
Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
528299|NCT00802685|E1|Reported Event|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.
Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
528300|NCT00802737|B4|Baseline|Total|Total of all reporting groups
528301|NCT00802737|B3|Baseline|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528302|NCT00802737|B2|Baseline|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528303|NCT00802737|B1|Baseline|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528304|NCT00802737|P3|Participant Flow|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528305|NCT00802737|P2|Participant Flow|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528368|NCT00790751|B1|Baseline|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
528369|NCT00790751|P4|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
528370|NCT00790751|P3|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
537601|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
528306|NCT00802737|P1|Participant Flow|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528307|NCT00802737|O4|Outcome|Total|This arm includes a total of all three arms combined.
528308|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528309|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528310|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528311|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528312|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528313|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528314|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528315|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528371|NCT00790751|P2|Participant Flow|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
537602|NCT00823043|O1|Outcome|Timolol Hemihydrate|
528316|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528317|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528318|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528319|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528320|NCT00802737|O4|Outcome|Total|This arm includes a total of all three arms combined.
528321|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528322|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528323|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528324|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528325|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528372|NCT00790751|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
528373|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
528326|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528327|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528328|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528329|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528330|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528331|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528332|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528333|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528334|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528374|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
528375|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
537603|NCT00823043|E1|Reported Event|Total Subjects Surveyed|
528335|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528336|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528337|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528338|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528339|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528340|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528341|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528342|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528343|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528376|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
528377|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
539368|NCT00827372|E1|Reported Event|Overall|All patients who were treated
528344|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528345|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528346|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528347|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528348|NCT00802737|E3|Reported Event|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
528349|NCT00802737|E2|Reported Event|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
528350|NCT00802737|E1|Reported Event|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
528351|NCT00790738|B3|Baseline|Total|Total of all reporting groups
528352|NCT00790738|B2|Baseline|Placebo|"placebo
placebo: placebo"
528353|NCT00790738|B1|Baseline|Liothyronine (T3)|"liothyronine (T3)
Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day"
528354|NCT00790738|P2|Participant Flow|Placebo|"placebo
placebo: placebo"
528355|NCT00790738|P1|Participant Flow|Liothyronine (T3)|"liothyronine (T3)
Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
528356|NCT00790738|O2|Outcome|Placebo|"placebo
placebo: placebo"
528357|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)
Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
528358|NCT00790738|O2|Outcome|Placebo|"placebo
placebo: placebo"
528359|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)
Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
528360|NCT00790738|O2|Outcome|Placebo|"placebo
placebo: placebo"
528361|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)
Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
528362|NCT00790738|E2|Reported Event|Placebo|"placebo
placebo: placebo"
528363|NCT00790738|E1|Reported Event|Liothyronine (T3)|"liothyronine (T3)
Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day"
528364|NCT00790751|B5|Baseline|Total|Total of all reporting groups
528365|NCT00790751|B4|Baseline|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
528550|NCT00791128|O1|Outcome|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
528378|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
528379|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
528380|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
528381|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
528382|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
528383|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
528384|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
528385|NCT00790751|E4|Reported Event|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
528386|NCT00790751|E3|Reported Event|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
528387|NCT00790751|E2|Reported Event|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
528388|NCT00790751|E1|Reported Event|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
528389|NCT00790790|B4|Baseline|Total|Total of all reporting groups
528390|NCT00790790|B3|Baseline|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528391|NCT00790790|B2|Baseline|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528392|NCT00790790|B1|Baseline|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528393|NCT00790790|P3|Participant Flow|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528394|NCT00790790|P2|Participant Flow|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528395|NCT00790790|P1|Participant Flow|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528396|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528397|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528398|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528399|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528400|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528401|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528402|NCT00790790|O2|Outcome|Compound 645838 (CLm)|Plasma Compound 645838 concentrations were obtained following daily oral doses of LY545694 21 mg to 105 mg.
528403|NCT00790790|O1|Outcome|LY545694 Clearance (CLp)|Plasma LY545694 concentrations were obtained following daily oral doses of LY545694 21 mg to LY545694 105 mg.
528404|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528405|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528406|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528407|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528669|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528408|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528409|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528410|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528411|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528412|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528413|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528414|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528415|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528416|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528417|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528418|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528419|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528420|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528421|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528422|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528423|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528424|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528425|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528426|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528427|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528428|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528429|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528551|NCT00791128|E1|Reported Event|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
528430|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528431|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528432|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528433|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528434|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528435|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528436|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528437|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528438|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528439|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528440|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528441|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528442|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528443|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528444|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528445|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528446|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528447|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528448|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528449|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528450|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528451|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528537|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001
Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528552|NCT00796614|B5|Baseline|Total|Total of all reporting groups
528452|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528453|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528454|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528455|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528456|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528457|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528458|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528459|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528460|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528461|NCT00790790|E6|Reported Event|LY545694 105 mg Washout|1 week washout period from taking 105 mg LY545694
528462|NCT00790790|E5|Reported Event|LY545694 49 mg Washout|1 week washout period from taking 49 mg LY545694
528463|NCT00790790|E4|Reported Event|Placebo Washout|1 week washout period from taking placebo
528464|NCT00790790|E3|Reported Event|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
528465|NCT00790790|E2|Reported Event|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) twice daily (BID) oral (po) were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
528466|NCT00790790|E1|Reported Event|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
528467|NCT00790803|B1|Baseline|Macugen|"Single arm pilot trial
Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
528468|NCT00790803|P1|Participant Flow|Macugen|"Single arm pilot trial
Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
528469|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial
Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
528470|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial
Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
528471|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial
Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
528472|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial
Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
528473|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial
Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
528474|NCT00790803|E1|Reported Event|Macugen|"Single arm pilot trial
Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
528475|NCT00790855|B1|Baseline|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
528476|NCT00790855|P1|Participant Flow|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
528477|NCT00790855|O1|Outcome|Bendamustine (75 mg/m^2)|75 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
528478|NCT00790855|O1|Outcome|Bendamustine|Starting dose 50 mg/m^2 intravenously, over 2 hours twice on Days 1-4 of every 4 week study cycle, with dose escalation of 25 mg/m^2 for 3 levels.
528479|NCT00790855|E1|Reported Event|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
528480|NCT00790907|B4|Baseline|Total|Total of all reporting groups
528538|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001
ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528613|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528481|NCT00790907|B3|Baseline|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
528482|NCT00790907|B2|Baseline|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
528483|NCT00790907|B1|Baseline|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
528484|NCT00790907|P3|Participant Flow|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
528485|NCT00790907|P2|Participant Flow|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
528486|NCT00790907|P1|Participant Flow|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
528487|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
528488|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
528489|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
528490|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
528491|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
528539|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001
Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528540|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001
ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528541|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001
Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528492|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
528493|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
528494|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
528495|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
528496|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
528497|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
528498|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
528499|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
528500|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
528501|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
528542|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001
ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528543|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001
Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528544|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001
ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528502|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
528503|NCT00790907|E3|Reported Event|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
528504|NCT00790907|E2|Reported Event|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
528505|NCT00790907|E1|Reported Event|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
528506|NCT00791037|B1|Baseline|Treatment (Vaccine Therapy+ex Vivo T Cell Expansion)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.
Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.
HER-2/neu peptide vaccine: Given ID
leukapheresis: Undergo leukapheresis
ex vivo-expanded HER2-specific T cells: Given IV
cyclophosphamide: Given IV
sargramostim: Given ID
laboratory biomarker analysis: Correlative study"
528507|NCT00791037|P1|Participant Flow|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.
Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.
HER-2/neu peptide vaccine: Given ID
leukapheresis: Undergo leukapheresis
ex vivo-expanded HER2-specific T cells: Given IV
cyclophosphamide: Given IV
sargramostim: Given ID
laboratory biomarker analysis: Correlative study"
528508|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.
Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.
HER-2/neu peptide vaccine: Given ID
leukapheresis: Undergo leukapheresis
ex vivo-expanded HER2-specific T cells: Given IV
cyclophosphamide: Given IV
sargramostim: Given ID
laboratory biomarker analysis: Correlative study"
528509|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.
Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.
HER-2/neu peptide vaccine: Given ID
leukapheresis: Undergo leukapheresis
ex vivo-expanded HER2-specific T cells: Given IV
cyclophosphamide: Given IV
sargramostim: Given ID
laboratory biomarker analysis: Correlative study"
528510|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.
Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.
HER-2/neu peptide vaccine: Given ID
leukapheresis: Undergo leukapheresis
ex vivo-expanded HER2-specific T cells: Given IV
cyclophosphamide: Given IV
sargramostim: Given ID
laboratory biomarker analysis: Correlative study"
528545|NCT00791102|E2|Reported Event|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001
Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528546|NCT00791102|E1|Reported Event|Topical ASP-1001|"Topical ASP-1001
ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528547|NCT00791128|B1|Baseline|EndoBarrier Liner Device|Subjects implanted with the EndoBarrier for up to 12 months.
528548|NCT00791128|P1|Participant Flow|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
539369|NCT00827502|B1|Baseline|Azithromycin|
528511|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy+ex Vivo-expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.
Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.
HER-2/neu peptide vaccine: Given ID
leukapheresis: Undergo leukapheresis
ex vivo-expanded HER2-specific T cells: Given IV
cyclophosphamide: Given IV
sargramostim: Given ID
laboratory biomarker analysis: Correlative study"
528512|NCT00791037|E1|Reported Event|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.
Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.
HER-2/neu peptide vaccine: Given ID
leukapheresis: Undergo leukapheresis
ex vivo-expanded HER2-specific T cells: Given IV
cyclophosphamide: Given IV
sargramostim: Given ID
laboratory biomarker analysis: Correlative study"
528513|NCT00791076|B1|Baseline|All Study Participants|"2pmol/kg-1/min-1 saline infused continuously over 72 hours OR
2pmol/kg-1/min-1 PP infused continuously over 72 hours."
528514|NCT00791076|P1|Participant Flow|All Participants|"Saline
Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.
OR
Pancreatic Polypeptide
Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
528515|NCT00791076|O2|Outcome|Pancreatic Polypeptide|"Pancreatic Polypeptide
Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
528516|NCT00791076|O1|Outcome|Saline Placebo|"Saline
Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
528517|NCT00791076|O2|Outcome|Pancreatic Polypeptide|"Pancreatic Polypeptide
Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
528518|NCT00791076|O1|Outcome|Saline Placebo|"Saline
Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
528519|NCT00791076|E2|Reported Event|Pancreatic Polypeptide|"Pancreatic Polypeptide
Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
528520|NCT00791076|E1|Reported Event|Saline Placebo|"Saline
Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
528521|NCT00791089|B3|Baseline|Total|Total of all reporting groups
528522|NCT00791089|B2|Baseline|Placebo, Ablation, Sinus Rhythm|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.
placebo: Control group will receive placebo before & after ablation."
528523|NCT00791089|B1|Baseline|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.
LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.
LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
528524|NCT00791089|P2|Participant Flow|Placebo, Ablation, Sinus Rhythm|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.
placebo: Control group will receive placebo before & after ablation."
528525|NCT00791089|P1|Participant Flow|Fish Oil, Ablation, Sinus Rhythm|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.
LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.
LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
528526|NCT00791089|O2|Outcome|Placebo, Ablation|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.
placebo: Control group will receive placebo before & after ablation."
528527|NCT00791089|O1|Outcome|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.
LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.
LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
528528|NCT00791089|E2|Reported Event|Placebo, Ablation|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.
placebo: Control group will receive placebo before & after ablation."
528529|NCT00791089|E1|Reported Event|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.
LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.
LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
528530|NCT00791102|B1|Baseline|All Study Participants|
528531|NCT00791102|P2|Participant Flow|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001
Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528532|NCT00791102|P1|Participant Flow|Topical ASP-1001|"Topical ASP-1001
ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528533|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001
Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528534|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001
ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528535|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001
Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528536|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001
ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
528549|NCT00791128|O1|Outcome|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
528553|NCT00796614|B4|Baseline|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528554|NCT00796614|B3|Baseline|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528555|NCT00796614|B2|Baseline|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528556|NCT00796614|B1|Baseline|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528557|NCT00796614|P4|Participant Flow|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528558|NCT00796614|P3|Participant Flow|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528559|NCT00796614|P2|Participant Flow|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528560|NCT00796614|P1|Participant Flow|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528561|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528562|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528563|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528564|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528565|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528566|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528567|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528568|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528569|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528614|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528570|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528571|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528572|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528573|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528574|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528575|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528576|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528577|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528578|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528579|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528580|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528581|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528582|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528583|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528584|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528585|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528586|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528615|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
539814|NCT00822354|O2|Outcome|Week 4 of Treatment|
528587|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528588|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528589|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528590|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528591|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528592|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528593|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528594|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528595|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528596|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528597|NCT00796614|E4|Reported Event|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528598|NCT00796614|E3|Reported Event|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528599|NCT00796614|E2|Reported Event|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528600|NCT00796614|E1|Reported Event|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
528601|NCT00796653|B5|Baseline|Total|Total of all reporting groups
528602|NCT00796653|B4|Baseline|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528603|NCT00796653|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528604|NCT00796653|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528605|NCT00796653|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528606|NCT00796653|P4|Participant Flow|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528607|NCT00796653|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528608|NCT00796653|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528609|NCT00796653|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528610|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528611|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528612|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528616|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528617|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528618|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528619|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528620|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528621|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528622|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528623|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528624|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528625|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528626|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528627|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528628|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528629|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528630|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528631|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528632|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528633|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528634|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
528635|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
528636|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
528637|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
528638|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
528639|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
528640|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
528641|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
528642|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
528643|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
528644|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
528645|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
528646|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
528647|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
528648|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
528649|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
528650|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
528651|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
528652|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
528653|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
528654|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
528655|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
528656|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
528657|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
528658|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528659|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528660|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528661|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528662|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528663|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528664|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528665|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528666|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528667|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528668|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528670|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528671|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528672|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528673|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528674|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528675|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528676|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528677|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528678|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528679|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528680|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528681|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528682|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528683|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528684|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528685|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528686|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528687|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528688|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528689|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528690|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528691|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528692|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528693|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528694|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528695|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528696|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528697|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528698|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528699|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528700|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528701|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528702|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528703|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528704|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528705|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528706|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528707|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528708|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528709|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528710|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528711|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528712|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528713|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528714|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528715|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528716|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528717|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528718|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528719|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528720|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528721|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528722|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528723|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528724|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528725|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528726|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528727|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528728|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528729|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528730|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528731|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528732|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528733|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528734|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528735|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528736|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528737|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528738|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528739|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528740|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528741|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528742|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528743|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528744|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528745|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528746|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528747|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528748|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528749|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528750|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528751|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528752|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528753|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528754|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528755|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528756|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528757|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528758|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528759|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528760|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528761|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528762|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528763|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528764|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528765|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528766|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528767|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528768|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528769|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528770|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528771|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528772|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528773|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528774|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528775|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528776|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528777|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528778|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528779|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528780|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528781|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528782|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528783|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528784|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528785|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528786|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528787|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528788|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528789|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528790|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528791|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528792|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528793|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528794|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528795|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528796|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528797|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528798|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528799|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528800|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528801|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528802|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528803|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528804|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528805|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528806|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528807|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528808|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528809|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528810|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528811|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528812|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528813|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528814|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528815|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528816|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528817|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528818|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528819|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528820|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528821|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528822|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528823|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528824|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528825|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528826|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528827|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528828|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528829|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528830|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528831|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528832|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528833|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528834|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528835|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528836|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528837|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528838|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528839|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528840|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528841|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528842|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528843|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528844|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528845|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528846|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528847|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528848|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528849|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528850|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528851|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528852|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528853|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528854|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528855|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528856|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528857|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528858|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528859|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528860|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528861|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528862|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528863|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528864|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528865|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528866|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528867|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528868|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528869|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528870|NCT00796653|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
528871|NCT00796653|E3|Reported Event|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
528872|NCT00796653|E2|Reported Event|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
528873|NCT00796653|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
528874|NCT00796666|B3|Baseline|Total|Total of all reporting groups
528875|NCT00796666|B2|Baseline|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528876|NCT00796666|B1|Baseline|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528877|NCT00796666|P2|Participant Flow|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528878|NCT00796666|P1|Participant Flow|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528879|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528880|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528881|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528882|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528883|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528884|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528885|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528886|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528887|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528888|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528889|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528890|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528891|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528892|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528893|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528894|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528895|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528896|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528897|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528898|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528899|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528900|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528901|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528902|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528903|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528904|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528905|NCT00796666|E2|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
528906|NCT00796666|E1|Reported Event|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
528907|NCT00796705|B5|Baseline|Total|Total of all reporting groups
528908|NCT00796705|B4|Baseline|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528909|NCT00796705|B3|Baseline|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528910|NCT00796705|B2|Baseline|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528911|NCT00796705|B1|Baseline|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528912|NCT00796705|P4|Participant Flow|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528913|NCT00796705|P3|Participant Flow|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1] at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528914|NCT00796705|P2|Participant Flow|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528915|NCT00796705|P1|Participant Flow|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528916|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528917|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528918|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528919|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528948|NCT00796705|E2|Reported Event|Non-Switcher/Etanercept|Subjects failing Etanercept at screening who were randomized to remain on Etanercept
528920|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528921|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528922|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528923|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528924|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528925|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528926|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528927|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528928|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528929|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528930|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528931|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528932|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528933|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
539815|NCT00822354|O1|Outcome|Pre-treatment|
528934|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528935|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528936|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528937|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528938|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528939|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528940|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528941|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528942|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528943|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
528944|NCT00796705|O2|Outcome|Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion and participants defined as etanercept failures [2] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg SQ injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.
Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.
Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528945|NCT00796705|O1|Outcome|Non-Switcher/ Adalimumab or Etanercept|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion and participants defined as etanercept failures [2] at screening who were randomized to receive etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.
Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.
Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
528946|NCT00796705|E4|Reported Event|Switcher/Etanercept to Adalimumab|Subjects failing Etanercept at screening who were randomized to switch to Adalimumab
528947|NCT00796705|E3|Reported Event|Switcher/Adalimumab to Etanercept|Subjects failing Adalimumab at screening who were randomized to switch to Etanercept
528949|NCT00796705|E1|Reported Event|Non-Switcher/Adalimumab|Subjects failing Adalimumab at screening who were randomized to remain on Adalimumab
528950|NCT00796718|B1|Baseline|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
528951|NCT00796718|P1|Participant Flow|Capecitabine|Capecitabine 825 milligrams per meter square (mg/m^2) orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
528952|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
528953|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
528954|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
528955|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
528956|NCT00796718|E1|Reported Event|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
528957|NCT00796744|B4|Baseline|Total|Total of all reporting groups
528958|NCT00796744|B3|Baseline|0.01% DSC127|0.01% DSC127 in Vehicle Control
528959|NCT00796744|B2|Baseline|0.03 % DSC127|0.03% DSC127 in Vehicle Control
528960|NCT00796744|B1|Baseline|Placebo Vehicle Control|control placebo vehicle
528961|NCT00796744|P3|Participant Flow|0.01% DSC127|0.01% DSC127 in Vehicle Control
528962|NCT00796744|P2|Participant Flow|0.03 % DSC127|0.03% DSC127 in Vehicle Control
528963|NCT00796744|P1|Participant Flow|Placebo Vehicle Control|control placebo vehicle
528964|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
528965|NCT00796744|O2|Outcome|0.03 % DSC127|0.03% DSC127 in Vehicle Control
528966|NCT00796744|O1|Outcome|Placebo Vehicle Control|control placebo vehicle
528967|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
528968|NCT00796744|O2|Outcome|0.03% DSC127|0.03% DSC127 in Vehicle Control
528969|NCT00796744|O1|Outcome|Placebo|control placebo vehicle
528970|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
528971|NCT00796744|O2|Outcome|0.03 % DSC127|0.03% DSC127 in Vehicle Control
528972|NCT00796744|O1|Outcome|Placebo Vehicle Control|control placebo vehicle
528973|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
528974|NCT00796744|O2|Outcome|0.03% DSC127|0.03% DSC127 in Vehicle Control
528975|NCT00796744|O1|Outcome|Placebo|control placebo vehicle
528976|NCT00796744|E3|Reported Event|0.01% DSC127|0.01% DSC127 in Vehicle Control
528977|NCT00796744|E2|Reported Event|0.03 % DSC127|0.03% DSC127 in Vehicle Control
528978|NCT00796744|E1|Reported Event|Placebo Vehicle Control|control placebo vehicle
528979|NCT00796757|B1|Baseline|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
528980|NCT00796757|P1|Participant Flow|Bevacizumab Plus (+) Interferon|Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 and Interferon alpha-2a (IFN) 3 million international units (MIU) subcutaneously (SC) 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
528981|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
528982|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
528983|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
528984|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
528985|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
528986|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
528987|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
528988|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
529045|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
528989|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
528990|NCT00796757|E1|Reported Event|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
528991|NCT00796822|B3|Baseline|Total|Total of all reporting groups
528992|NCT00796822|B2|Baseline|Placebo|"Participants will receive placebo.
Placebo : One pill three times a day for 8 weeks"
528993|NCT00796822|B1|Baseline|Pentoxifylline|"Participants will receive pentoxifylline.
Pentoxifylline : 400 mg three times a day for 8 weeks"
528994|NCT00796822|P2|Participant Flow|Placebo|"Participants will receive placebo.
Placebo : One pill three times a day for 8 weeks"
528995|NCT00796822|P1|Participant Flow|Pentoxifylline|"Participants will receive pentoxifylline.
Pentoxifylline : 400 mg three times a day for 8 weeks"
528996|NCT00796822|O2|Outcome|Placebo|"Participants will receive placebo.
Placebo : One pill three times a day for 8 weeks"
528997|NCT00796822|O1|Outcome|Pentoxifylline|"Participants will receive pentoxifylline.
Pentoxifylline : 400 mg three times a day for 8 weeks"
528998|NCT00796822|E2|Reported Event|Placebo|"Participants will receive placebo.
Placebo : One pill three times a day for 8 weeks"
528999|NCT00796822|E1|Reported Event|Pentoxifylline|"Participants will receive pentoxifylline.
Pentoxifylline : 400 mg three times a day for 8 weeks"
529000|NCT00796926|B3|Baseline|Total|Total of all reporting groups
529001|NCT00796926|B2|Baseline|Refresh|Four times a day for 6 weeks in each eye
529002|NCT00796926|B1|Baseline|Systane Ultra|four times a day for six weeks in each eye
529003|NCT00796926|P2|Participant Flow|Refresh|Four times a day for 6 weeks in each eye
529004|NCT00796926|P1|Participant Flow|Systane Ultra|four times a day for six weeks in each eye
529005|NCT00796926|O2|Outcome|Refresh|Four times a day for 6 weeks in each eye
529006|NCT00796926|O1|Outcome|Systane Ultra|four times a day for six weeks in each eye
529007|NCT00796926|E2|Reported Event|Refresh|Four times a day for 6 weeks in each eye
529008|NCT00796926|E1|Reported Event|Systane Ultra|four times a day for six weeks in each eye
529009|NCT00802841|B3|Baseline|Total|Total of all reporting groups
529010|NCT00802841|B2|Baseline|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
529011|NCT00802841|B1|Baseline|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
529012|NCT00802841|P2|Participant Flow|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
529013|NCT00802841|P1|Participant Flow|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
529014|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
529015|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
529016|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
529017|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
529018|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
529019|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
529020|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
529021|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
529022|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
529023|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
529024|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
529025|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
529026|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
529027|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
529028|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
529029|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
529030|NCT00802841|E4|Reported Event|Cross-over to Imatinib|600 mg QD
529031|NCT00802841|E3|Reported Event|Cross-over to Nilotinib|Nilotinib 400 mg BID
529032|NCT00802841|E2|Reported Event|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
529033|NCT00802841|E1|Reported Event|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
529034|NCT00802867|B1|Baseline|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
529035|NCT00802867|P1|Participant Flow|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
529036|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
529037|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
529038|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
529039|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
529040|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
529041|NCT00802867|E1|Reported Event|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
529042|NCT00802880|B1|Baseline|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529043|NCT00802880|P1|Participant Flow|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529044|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529046|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529047|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529048|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529049|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529050|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529051|NCT00802880|O4|Outcome|Total|
529052|NCT00802880|O3|Outcome|Progressive Metabolic Disease|
529053|NCT00802880|O2|Outcome|Stable Metabolic Disease|
529054|NCT00802880|O1|Outcome|Partial Metabolic Response|
529055|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529056|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529057|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529058|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529059|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529060|NCT00802880|E1|Reported Event|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
529061|NCT00802893|B1|Baseline|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period
OR
Placebo: placebo given BID for entire length of study"
529062|NCT00802893|P1|Participant Flow|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period
OR
Placebo: placebo given BID for entire length of study"
529063|NCT00802893|O1|Outcome|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period
OR
Placebo: placebo given BID for entire length of study"
529064|NCT00802893|O1|Outcome|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period
OR
Placebo: placebo given BID for entire length of study"
529065|NCT00802893|E1|Reported Event|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period
OR
Placebo: placebo given BID for entire length of study"
529066|NCT00802997|B3|Baseline|Total|Total of all reporting groups
529067|NCT00802997|B2|Baseline|Sham Procedure|
529068|NCT00802997|B1|Baseline|Lateral Branch Neurotomy|
529069|NCT00802997|P2|Participant Flow|Sham Procedure|The sham procedure was identical to the active treatment procedure but without the delivery of radiofrequency energy. The sham procedure was completed one time within 60 days of enrollment.
529070|NCT00802997|P1|Participant Flow|Lateral Branch Neurotomy|The lateral branch neurotomy procedure involved the ablation of the S1-S3 lateral branches and the L5 dorsal ramus using cooled radiofrequency electrodes. The procedure was completed one time within 60 days of enrollment.
529071|NCT00802997|O2|Outcome|Sham Procedure|
529072|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
529073|NCT00802997|O2|Outcome|Sham Procedure|
529074|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
529075|NCT00802997|O2|Outcome|Sham Procedure|
529076|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
529077|NCT00802997|E2|Reported Event|Sham Procedure|
529078|NCT00802997|E1|Reported Event|Lateral Branch Neurotomy|
529079|NCT00803010|B3|Baseline|Total|Total of all reporting groups
529080|NCT00803010|B2|Baseline|Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate
Tacrolimus / Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3
Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
529081|NCT00803010|B1|Baseline|Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin
Tacrolimus / Rapamycin: Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.
Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
529082|NCT00803010|P2|Participant Flow|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate
Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3
Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
529083|NCT00803010|P1|Participant Flow|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin
Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.
Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
529084|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate
Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3
Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
529085|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin
Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.
Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
529086|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate
Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3
Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
529087|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin
Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.
Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
529124|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
529088|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate
Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3
Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
529089|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin
Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.
Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
529090|NCT00803010|E2|Reported Event|Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate
Tacrolimus / Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3
Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
529091|NCT00803010|E1|Reported Event|Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin
Tacrolimus / Rapamycin: Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.
Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
529092|NCT00803023|B5|Baseline|Total|Total of all reporting groups
529093|NCT00803023|B4|Baseline|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
529094|NCT00803023|B3|Baseline|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
529095|NCT00803023|B2|Baseline|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
529096|NCT00803023|B1|Baseline|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
529097|NCT00803023|P4|Participant Flow|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
529098|NCT00803023|P3|Participant Flow|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
529099|NCT00803023|P2|Participant Flow|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
529100|NCT00803023|P1|Participant Flow|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
529101|NCT00803023|O4|Outcome|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
529102|NCT00803023|O3|Outcome|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
529103|NCT00803023|O2|Outcome|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
529104|NCT00803023|O1|Outcome|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
529105|NCT00803023|E4|Reported Event|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
529106|NCT00803023|E3|Reported Event|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
529107|NCT00803023|E2|Reported Event|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
529108|NCT00803023|E1|Reported Event|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
529109|NCT00803049|B5|Baseline|Total|Total of all reporting groups
529110|NCT00803049|B4|Baseline|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529111|NCT00803049|B3|Baseline|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529112|NCT00803049|B2|Baseline|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
529113|NCT00803049|B1|Baseline|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
529114|NCT00803049|P4|Participant Flow|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529115|NCT00803049|P3|Participant Flow|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529116|NCT00803049|P2|Participant Flow|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
529117|NCT00803049|P1|Participant Flow|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
529118|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529119|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529120|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
529121|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
529122|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529123|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529125|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
529126|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529127|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529128|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
529129|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
529130|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529131|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529132|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
529133|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
529134|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529135|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529136|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
529137|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
529138|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529139|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
529140|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
529141|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
529142|NCT00803049|E4|Reported Event|Teriflunomide 14 mg/14 mg|"Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
Excluded 1 participant randomized in 14 mg arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received correct dose of 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis."
529143|NCT00803049|E3|Reported Event|Placebo/Teriflunomide 14 mg|"Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
Excluded 1 participant randomized in placebo arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received 14 mg dose but included in teriflunomide 7 mg/7 mg arm for safety analysis."
529144|NCT00803049|E2|Reported Event|Teriflunomide 7 mg/7 mg|"Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
Included 2 participants randomized in placebo and teriflunomide 14 mg arm respectively in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participants received correct dose of teriflunomide 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis."
529145|NCT00803049|E1|Reported Event|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
529146|NCT00803062|B5|Baseline|Total|Total of all reporting groups
529147|NCT00803062|B4|Baseline|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529148|NCT00803062|B3|Baseline|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
529149|NCT00803062|B2|Baseline|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529175|NCT00803101|P1|Participant Flow|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline international normalized ratio (INR), amount of coagulation factor IX and body-weight.
529150|NCT00803062|B1|Baseline|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
529151|NCT00803062|P4|Participant Flow|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529152|NCT00803062|P3|Participant Flow|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
529153|NCT00803062|P2|Participant Flow|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529154|NCT00803062|P1|Participant Flow|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
529155|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529156|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
529157|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529158|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
529159|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529160|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
529161|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529162|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
529163|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529164|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
529165|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529166|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
529167|NCT00803062|E4|Reported Event|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529168|NCT00803062|E3|Reported Event|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
529169|NCT00803062|E2|Reported Event|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
529170|NCT00803062|E1|Reported Event|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
529171|NCT00803101|B3|Baseline|Total|Total of all reporting groups
529172|NCT00803101|B2|Baseline|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
529173|NCT00803101|B1|Baseline|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
529174|NCT00803101|P2|Participant Flow|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
529176|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
529177|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
529178|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
529179|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
529180|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
529181|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
529182|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
529183|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
529184|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
529185|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
529186|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
529187|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
529188|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
529189|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
529190|NCT00803101|E2|Reported Event|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
529191|NCT00803101|E1|Reported Event|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
529192|NCT00803114|B3|Baseline|Total|Total of all reporting groups
529193|NCT00803114|B2|Baseline|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
529194|NCT00803114|B1|Baseline|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
529195|NCT00803114|P2|Participant Flow|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
529196|NCT00803114|P1|Participant Flow|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
529197|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
529198|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
529199|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
529200|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
529201|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
529202|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
529203|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
529204|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
529205|NCT00803179|B1|Baseline|Growth Hormone Therapy|"Nutropin AQ:
Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
529206|NCT00803179|P1|Participant Flow|Growth Hormone Therapy|"Nutropin AQ:
Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
529207|NCT00803179|O1|Outcome|Growth Hormone Therapy|"Nutropin Aqueous (AQ):
Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
529208|NCT00803179|E1|Reported Event|Growth Hormone Therapy|"Nutropin AQ:
Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
529209|NCT00803244|B3|Baseline|Total|Total of all reporting groups
529210|NCT00803244|B2|Baseline|Placebo|Placebo tablet
529211|NCT00803244|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
529212|NCT00803244|P2|Participant Flow|Placebo|Placebo tablet
529213|NCT00803244|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
529214|NCT00803244|O2|Outcome|Placebo|Placebo tablet
529215|NCT00803244|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
529216|NCT00803244|O2|Outcome|Placebo|Placebo tablet
529217|NCT00803244|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
529218|NCT00803244|E2|Reported Event|Placebo|Placebo tablet
529219|NCT00803244|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
529220|NCT00803270|B3|Baseline|Total|Total of all reporting groups
529221|NCT00803270|B2|Baseline|Non Surgical Treatment|"The non-surgical treatment will include two components:
Pharmacological therapy with any FDA approved OAB drug in approved doses; and
Behavioral therapy."
529222|NCT00803270|B1|Baseline|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
529223|NCT00803270|P2|Participant Flow|Non Surgical Treatment|"The non-surgical treatment will include two components:
Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and
Behavioral therapy."
529224|NCT00803270|P1|Participant Flow|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
529225|NCT00803270|O2|Outcome|Non Surgical Treatment|"The non-surgical treatment will include two components:
Pharmacological therapy with any FDA approved OAB drug in approved doses; and
Behavioral therapy."
529226|NCT00803270|O1|Outcome|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
529227|NCT00803270|O2|Outcome|Non Surgical Treatment|"The non-surgical treatment will include two components:
Pharmacological therapy with any FDA approved OAB drug in approved doses; and
Behavioral therapy."
529228|NCT00803270|O1|Outcome|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
529229|NCT00803270|E2|Reported Event|Non Surgical Treatment|"The non-surgical treatment will include two components:
Pharmacological therapy with any FDA approved OAB drug in approved doses; and
Behavioral therapy."
529230|NCT00803270|E1|Reported Event|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
529231|NCT00803283|B3|Baseline|Total|Total of all reporting groups
529232|NCT00803283|B2|Baseline|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529233|NCT00803283|B1|Baseline|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529234|NCT00803283|P2|Participant Flow|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529235|NCT00803283|P1|Participant Flow|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529236|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529237|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529238|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529239|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529240|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529241|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529242|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529243|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529244|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529245|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529246|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529247|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529248|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529249|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529250|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529251|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529252|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529253|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529254|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529255|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529256|NCT00803283|E2|Reported Event|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529257|NCT00803283|E1|Reported Event|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
529258|NCT00803361|B3|Baseline|Total|Total of all reporting groups
529259|NCT00803361|B2|Baseline|Placebo|placebo capsules, oral, once a day for 15 weeks
529260|NCT00803361|B1|Baseline|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
529261|NCT00803361|P2|Participant Flow|Placebo|placebo capsules, oral, once a day for 15 weeks
529262|NCT00803361|P1|Participant Flow|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
529263|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
529264|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
529265|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
529266|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
529267|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
529268|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
529269|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
529270|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
529271|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
529272|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
529273|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
529274|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
529275|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
529276|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
529277|NCT00803361|E2|Reported Event|Placebo|placebo capsules, oral, once a day for 15 weeks
529278|NCT00803361|E1|Reported Event|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
529279|NCT00803400|B3|Baseline|Total|Total of all reporting groups
529280|NCT00803400|B2|Baseline|Alprazolam + Aerobic Exercise|
529281|NCT00803400|B1|Baseline|Alprazolam|
529282|NCT00803400|P2|Participant Flow|Alprazolam + Aerobic Exercise|
529283|NCT00803400|P1|Participant Flow|Alprazolam|
529284|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
529285|NCT00803400|O1|Outcome|Alprazolam|
529286|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
529287|NCT00803400|O1|Outcome|Alprazolam|
529288|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
529289|NCT00803400|O1|Outcome|Alprazolam|
529290|NCT00803400|E2|Reported Event|Alprazolam + Aerobic Exercise|
529291|NCT00803400|E1|Reported Event|Alprazolam|
529292|NCT00803413|B5|Baseline|Total|Total of all reporting groups
529293|NCT00803413|B4|Baseline|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
529294|NCT00803413|B3|Baseline|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
529295|NCT00803413|B2|Baseline|Supervised Walking|
529296|NCT00803413|B1|Baseline|Back School|
529297|NCT00803413|P4|Participant Flow|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
529298|NCT00803413|P3|Participant Flow|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
529299|NCT00803413|P2|Participant Flow|Supervised Walking|
529300|NCT00803413|P1|Participant Flow|Back School|
529301|NCT00803413|O4|Outcome|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
529390|NCT00803686|P4|Participant Flow|Fortical Nasal Spray (Part 2, Period 3)|After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter the open label Part 2, Period 3 and were given Fortical Nasal Spray 2 hours after the evening meal
529302|NCT00803413|O3|Outcome|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
529303|NCT00803413|O2|Outcome|Supervised Walking|
529304|NCT00803413|O1|Outcome|Back School|
529305|NCT00803413|O4|Outcome|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
529306|NCT00803413|O3|Outcome|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
529307|NCT00803413|O2|Outcome|Supervised Walking|
529308|NCT00803413|O1|Outcome|Back School|
529309|NCT00803517|B3|Baseline|Total|Total of all reporting groups
529310|NCT00803517|B2|Baseline|Focal Laser Photocoagulation|
529311|NCT00803517|B1|Baseline|Photodynamic Therapy|
529312|NCT00803517|P2|Participant Flow|Focal Laser Photocoagulation|
529313|NCT00803517|P1|Participant Flow|Photodynamic Therapy|
529314|NCT00803517|O2|Outcome|Focal Laser Photocoagulation|
529315|NCT00803517|O1|Outcome|Photodynamic Therapy|
529316|NCT00803517|O2|Outcome|Focal Laser Photocoagulation|
529317|NCT00803517|O1|Outcome|Photodynamic Therapy|
529318|NCT00803543|B3|Baseline|Total|Total of all reporting groups
529319|NCT00803543|B2|Baseline|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
529320|NCT00803543|B1|Baseline|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
529321|NCT00803543|P2|Participant Flow|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
529322|NCT00803543|P1|Participant Flow|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
529323|NCT00803543|O2|Outcome|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
529324|NCT00803543|O1|Outcome|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
529325|NCT00803543|O2|Outcome|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
529326|NCT00803543|O1|Outcome|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
529327|NCT00803543|O2|Outcome|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
529328|NCT00803543|O1|Outcome|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
529329|NCT00803543|O2|Outcome|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
529330|NCT00803543|O1|Outcome|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
529331|NCT00803543|E2|Reported Event|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
529332|NCT00803543|E1|Reported Event|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
529333|NCT00803595|B4|Baseline|Total|Total of all reporting groups
529334|NCT00803595|B3|Baseline|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
529335|NCT00803595|B2|Baseline|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
529336|NCT00803595|B1|Baseline|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
529337|NCT00803595|P3|Participant Flow|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
529338|NCT00803595|P2|Participant Flow|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
529339|NCT00803595|P1|Participant Flow|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
529340|NCT00803595|O3|Outcome|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
529341|NCT00803595|O2|Outcome|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
529342|NCT00803595|O1|Outcome|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
529343|NCT00803595|O3|Outcome|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
529344|NCT00803595|O2|Outcome|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
529345|NCT00803595|O1|Outcome|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
529346|NCT00803595|E3|Reported Event|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
529347|NCT00803595|E2|Reported Event|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
529348|NCT00803595|E1|Reported Event|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
529349|NCT00803634|B3|Baseline|Total|Total of all reporting groups
529350|NCT00803634|B2|Baseline|SOC IV Antihypertensive Therapy|All randomized and eligible patients who received any SOC dose.
529351|NCT00803634|B1|Baseline|Clevidipine Emulsion|All randomized and eligible patients who received any dose of clevidipine.
529352|NCT00803634|P2|Participant Flow|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529391|NCT00803686|P3|Participant Flow|Oral rsCT Tablets (Part 2, Period 3)|After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter open label Part 2, Period 3, and received oral rsCT tablets given 2 hours after the evening meal.
529353|NCT00803634|P1|Participant Flow|Clevidipine|Clevidipine (0.5 mg/mL in 20% lipid emulsion) was administered intravenously via a single dedicated line to all patients randomized to the clevidipine arm. Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529354|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529355|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529356|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529357|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529358|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529359|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529360|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529361|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529362|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529363|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529364|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529365|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529366|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529438|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529367|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529368|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529369|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529370|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529371|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529372|NCT00803634|O2|Outcome|SOC IV Therapy|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529373|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529374|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529375|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529376|NCT00803634|E2|Reported Event|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
529377|NCT00803634|E1|Reported Event|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
529378|NCT00803647|B1|Baseline|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
529379|NCT00803647|P1|Participant Flow|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
529380|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
529381|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
529382|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
529383|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
529384|NCT00803647|E1|Reported Event|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
529385|NCT00803686|B5|Baseline|Total|Total of all reporting groups
529386|NCT00803686|B4|Baseline|Part 2 Open Label Fortical Intranasal Spray|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal
529387|NCT00803686|B3|Baseline|Part 2 Open Label--Oral rsCT Tablets|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal.
529388|NCT00803686|B2|Baseline|Part 1 Oral Placebo Tablets|Subjects were given oral placebo tablets 4 hours after the evening meal.
529389|NCT00803686|B1|Baseline|Part 1 Oral rsCT Tablets|Subjects were given oral rsCT tablets 4 hours after the evening meal
529439|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529392|NCT00803686|P2|Participant Flow|Oral Placebo|In Part 1, Period 1, 6 Subjects each were given oral placebo tablets 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral rsCT tablets 4 hours after the evening meal.
529393|NCT00803686|P1|Participant Flow|Oral Recombinant Salmon Calcitonin (rsCT)|In Part 1, Period 1, 6 Subjects each were given rsCT tablets or 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral placebo 4 hours after the evening meal.
529394|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|After completing Part 1, subjects were eligible to enter the open-label Part 2. Two dropped out and 4 received Fortical nasal spray 2 hours after the evening meal.
529395|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|After completing Part 1, subjects were eligible to enter the open-label Part 2. One dropped out and 5 entered and received oral rsCT tablets given 2 hours after the evening meal.
529396|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
529397|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
529398|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|After completing Part 1, subjects were eligible to enter the open-label Part 2. Two dropped out and 4 received Fortical nasal spray 2 hours after the evening meal.
529399|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|After completing Part 1, subjects were eligible to enter the open-label Part 2. One dropped out and 5 entered and received oral rsCT tablets given 2 hours after the evening meal.
529400|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
529401|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
529402|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|Subjects were given Fortical (rsCT) nasal spray four hours after the evening meal
529403|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|Subjects were given oral rsCT tablets four hours after the evening meal
529404|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
529405|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
529406|NCT00803686|E4|Reported Event|Part 2 Open Label Fortical Intranasal Spray|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal
529407|NCT00803686|E3|Reported Event|Part 2 Open Label--Oral rsCT Tablets|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal.
529408|NCT00803686|E2|Reported Event|Part 1 Oral Placebo Tablets|Subjects were given oral placebo tablets 4 hours after the evening meal.
529409|NCT00803686|E1|Reported Event|Part 1 Oral rsCT Tablets|Subjects were given oral rsCT tablets 4 hours after the evening meal
529410|NCT00803712|B3|Baseline|Total|Total of all reporting groups
529411|NCT00803712|B2|Baseline|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529412|NCT00803712|B1|Baseline|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529413|NCT00803712|P2|Participant Flow|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529414|NCT00803712|P1|Participant Flow|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529415|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529416|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529417|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529418|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529419|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529420|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529421|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529422|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529423|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529424|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529425|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529426|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529427|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529428|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529429|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529430|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529431|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529432|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529433|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529434|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529435|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529436|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529437|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
539816|NCT00822354|O4|Outcome|Week 4 of Placebo|
529440|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529441|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529442|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529443|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529444|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529445|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529446|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529447|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529448|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529449|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529450|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529451|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529452|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529453|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529454|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529455|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529456|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529457|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529458|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529459|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529460|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529461|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529462|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529463|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529464|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529465|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529466|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529467|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529468|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529469|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529470|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529471|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529472|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529473|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529474|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529475|NCT00803712|E2|Reported Event|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
529476|NCT00803712|E1|Reported Event|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
529477|NCT00803738|B3|Baseline|Total|Total of all reporting groups
529478|NCT00803738|B2|Baseline|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
529479|NCT00803738|B1|Baseline|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
529480|NCT00803738|P2|Participant Flow|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
529481|NCT00803738|P1|Participant Flow|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
529482|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
529483|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
529484|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
529485|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
529605|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529486|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
529487|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
529488|NCT00803738|E2|Reported Event|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
529489|NCT00803738|E1|Reported Event|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
529490|NCT00803751|B3|Baseline|Total|Total of all reporting groups
529491|NCT00803751|B2|Baseline|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
529492|NCT00803751|B1|Baseline|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
529493|NCT00803751|P2|Participant Flow|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
529494|NCT00803751|P1|Participant Flow|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
529495|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
529496|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
529497|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
529498|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
529499|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
529500|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
529501|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
529502|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
529503|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
529504|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
529505|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
529506|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
529507|NCT00803751|E2|Reported Event|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
529508|NCT00803751|E1|Reported Event|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
529509|NCT00803777|B1|Baseline|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
529510|NCT00803777|P1|Participant Flow|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
529511|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
529512|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
529513|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
529514|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
529515|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
529516|NCT00803777|E1|Reported Event|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
529517|NCT00803790|B3|Baseline|Total|Total of all reporting groups
529518|NCT00803790|B2|Baseline|Part 2|"Alendronate+vitamin D combo, then vitamin D: In Period 1 participants received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet, and in Period 2 a single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets. A washout of at least 12 days separated each treatment period.
Vitamin D, then alendronate+vitamin D combo: In Period 1 participants received a single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets, and in Period 2 a single dose of 70mg alendronate+5600 IU vitamin D combination tablet. A washout of at least 12 days separated each treatment period."
529551|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529606|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
539817|NCT00822354|O3|Outcome|Pre-placebo|
529519|NCT00803790|B1|Baseline|Part 1|"Alendronate+vitamin D combo, then alendronate: In Period 1 participants received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet, and in Period 2 a single dose of 70mg alendronate tablet. A washout of at least 12 days separated each treatment period.
Alendronate, then alendronate+vitamin D combo: In Period 1 participants received 70mg alendronate tablet, and in Period 2 a single dose of 70mg alendronate+5600 IU vitamin D combination tablet. A washout of at least 12 days separated each treatment period."
529520|NCT00803790|P4|Participant Flow|Part 2 Vitamin D, Then Alendronate+Vitamin D Combo|Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
529521|NCT00803790|P3|Participant Flow|Part 2 Alendronate+Vitamin D Combo, Then Vitamin D|Participants in Part 2 received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period.
529522|NCT00803790|P2|Participant Flow|Part 1 Alendronate, Then Alendronate+Vitamin D Combo|Participants in Part 1 received a single dose of 70mg alendronate tablet in Period 1 followed by a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
529523|NCT00803790|P1|Participant Flow|Part 1 Alendronate+Vitamin D Combo, Then Alendronate|Participants in Part 1 received a single dose of 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by a single dose of 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period.
529524|NCT00803790|O2|Outcome|Vitamin D|Single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets
529525|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|Single dose of 70 mg alendronate+5600 IU vitamin D combination tablet
529526|NCT00803790|O2|Outcome|Vitamin D|Single dose of 5600 IU vitamin D administered as 2 x 2800 IU tablets
529527|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|A single dose of 70mg alendronate+5600 IU vitamin D combination tablet
529528|NCT00803790|O2|Outcome|Alendronate|Single dose of 70mg alendronate tablet
529529|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|Single dose of 70mg alendronate+5600 IU vitamin D combination tablet
529530|NCT00803790|E3|Reported Event|Vitamin D|Single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets
529531|NCT00803790|E2|Reported Event|Alendronate|Single dose of 70mg alendronate tablet
529532|NCT00803790|E1|Reported Event|Alendronate+Vitamin D Combo|Single dose of 70 mg alendronate+5600 IU vitamin D combination tablet
529533|NCT00803959|B3|Baseline|Total|Total of all reporting groups
529534|NCT00803959|B2|Baseline|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529535|NCT00803959|B1|Baseline|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529536|NCT00803959|P2|Participant Flow|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529537|NCT00803959|P1|Participant Flow|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529538|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529539|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529540|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529541|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529542|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529543|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529544|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529545|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529546|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529547|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529548|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529549|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529550|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529603|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529552|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529553|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529554|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529555|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529556|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529557|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529558|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529559|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529560|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529561|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529562|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529563|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529564|NCT00803959|E2|Reported Event|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529565|NCT00803959|E1|Reported Event|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
529566|NCT00804193|B4|Baseline|Total|Total of all reporting groups
529567|NCT00804193|B3|Baseline|Vehicle Product|placebo of test product
529568|NCT00804193|B2|Baseline|Reference Product|Loprox® Topical Suspension 0.77%
529569|NCT00804193|B1|Baseline|Test Product|Ciclopirox Olamine Topical Suspension
529570|NCT00804193|P3|Participant Flow|Vehicle Product|placebo of test product was applied treatment two times a day for 4 weeks
529571|NCT00804193|P2|Participant Flow|Reference Product|Loprox® Topical Suspension 0.77%; the Reference Product was applied treatment two times a day for 4 weeks
529572|NCT00804193|P1|Participant Flow|Test Product|Ciclopirox Olamine Topical Suspension; the Test Product was applied treatment two times a day for 4 weeks
529573|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
529574|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
529575|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
529576|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
529577|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
529578|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
529579|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
529580|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
529581|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
529582|NCT00804193|E3|Reported Event|Vehicle Product|placebo of test product
529583|NCT00804193|E2|Reported Event|Reference Product|Loprox® Topical Suspension 0.77%
529584|NCT00804193|E1|Reported Event|Test Product|Ciclopirox Olamine Topical Suspension
529585|NCT00804570|B3|Baseline|Total|Total of all reporting groups
529586|NCT00804570|B2|Baseline|Placebo|once daily, orally, 16 weeks
529587|NCT00804570|B1|Baseline|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529588|NCT00804570|P2|Participant Flow|Placebo|once daily, orally, 16 weeks
529589|NCT00804570|P1|Participant Flow|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529590|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529591|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529592|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529593|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529594|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529595|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529596|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529597|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529598|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529599|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529600|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529601|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529602|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529607|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529608|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
529609|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
529610|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529611|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529612|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529613|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529614|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529615|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529616|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529617|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529618|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529619|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529620|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529621|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529622|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529623|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529624|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529625|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529626|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529627|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529628|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529629|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529630|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529631|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529632|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529633|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529634|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529635|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529636|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529637|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529638|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529639|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529640|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
529641|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
529642|NCT00804570|E2|Reported Event|Placebo|once daily (QD), orally (PO), 16 weeks
529643|NCT00804570|E1|Reported Event|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
529644|NCT00804596|B1|Baseline|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
529645|NCT00804596|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
529646|NCT00804596|O1|Outcome|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
529647|NCT00804596|O1|Outcome|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
529648|NCT00804596|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
529649|NCT00804609|B3|Baseline|Total|Total of all reporting groups
529650|NCT00804609|B2|Baseline|Epidural DepoDur Following Spinal Anesthetic|"Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
DepoDur: Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space.
Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug."
529705|NCT00804687|P6|Participant Flow|Pseudoephedrine Then Placebo Then JNJ-39220675|Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
529740|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
529964|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
529651|NCT00804609|B1|Baseline|Epidural DepoDur Following Epidural Lidocaine Administration|"Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
DepoDur: All participant underwent cesarean delivery. An epidural top-up anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered.
Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration."
529652|NCT00804609|P2|Participant Flow|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
529653|NCT00804609|P1|Participant Flow|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
529654|NCT00804609|O2|Outcome|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
529655|NCT00804609|O1|Outcome|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
529656|NCT00804609|E2|Reported Event|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
529657|NCT00804609|E1|Reported Event|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
529658|NCT00804648|B1|Baseline|Overall|
529659|NCT00804648|P6|Participant Flow|Maleate Gel/Maleate/Hemihydrate|Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
529660|NCT00804648|P5|Participant Flow|Maleate/Hemihydrate/Maleate Gel|Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
529661|NCT00804648|P4|Participant Flow|Hemihydrate/Maleate Gel/Maleate|Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
529662|NCT00804648|P3|Participant Flow|Maleate Gel/Hemihydrate/Maleate|Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
529663|NCT00804648|P2|Participant Flow|Maleate/Maleate Gel/Hemihydrate|Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
529664|NCT00804648|P1|Participant Flow|Hemihydrate/Maleate/Maleate Gel|Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
529665|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529666|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529667|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529668|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529669|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529670|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529671|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529672|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529673|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529674|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529675|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529676|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529677|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529678|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529679|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529680|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529681|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529682|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529683|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529684|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529685|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529686|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529687|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529688|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529689|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529690|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529691|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529692|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529693|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529694|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529695|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529696|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529697|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529698|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
529699|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
529700|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
529701|NCT00804648|E3|Reported Event|Timolol Maleate Gel Forming Solution 0.5%|
529702|NCT00804648|E2|Reported Event|Timolol Maleate 0.5%|
529703|NCT00804648|E1|Reported Event|Timolol Hemihydrate 0.5%|
529704|NCT00804687|B1|Baseline|Entire Study Population|Includes all participants randomized in the study.
529738|NCT00804843|P1|Participant Flow|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
529739|NCT00804843|O2|Outcome|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
529706|NCT00804687|P5|Participant Flow|Pseudoephedrine Then JNJ-39220675 Then Placebo|Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
529707|NCT00804687|P4|Participant Flow|Placebo Then Pseudoephedrine Then JNJ-39220675|Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
529708|NCT00804687|P3|Participant Flow|Placebo Then JNJ-39220675 Then Pseudoephedrine|Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
529709|NCT00804687|P2|Participant Flow|JNJ-39220675 Then Placebo Then Pseudoephedrine|Single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
529710|NCT00804687|P1|Participant Flow|JNJ-39220675 Then Pseudoephedrine Then Placebo|Single-dose of JNJ-39220675 as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 milligram (mg) pseudoephedrine tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
529711|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
529712|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
529713|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
529714|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
529715|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
529716|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
529717|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
529718|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
529719|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
529720|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
529721|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
529722|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
529723|NCT00804687|E3|Reported Event|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
529724|NCT00804687|E2|Reported Event|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
529725|NCT00804687|E1|Reported Event|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
529726|NCT00804713|B1|Baseline|All Study Participants|Subjects administered the Tuberculosis skin test (TST), Battey skin test, QFT-GIT, and T-spot
529727|NCT00804713|P1|Participant Flow|All Study Participants|Subjects administered the tuberculosis skin test (TST), Battey skin test, Quantiferon Gold-in-tube (QFT-GIT), and T-Spot
529728|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test
Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot"
529729|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
All study participants: 0.1 mcg/mL (1 dose) Battey skin test antigen administered using the Mantoux method.
All study participants: Administer TB Skin test
All study participants: Perform QFT-GIT TB test
All study participants: Perform T-Spot TB test"
529730|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
All study participants: 0.1 mcg/mL (1 dose) Battey skin test antigen administered using the Mantoux method.
All study participants: Administer TB Skin test
All study participants: Perform QFT-GIT TB test
All study participants: Perform T-Spot TB test"
529731|NCT00804713|O1|Outcome|QFT-GIT|"Subjects administered the QFT-GIT TB test
QFT-GIT: Perform QFT-GIT TB test"
529732|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test
Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot"
529733|NCT00804713|E1|Reported Event|All Study Participants|Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
529734|NCT00804843|B3|Baseline|Total|Total of all reporting groups
529735|NCT00804843|B2|Baseline|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
529736|NCT00804843|B1|Baseline|Statin 80 mg + Niacin ER|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.
529737|NCT00804843|P2|Participant Flow|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
529741|NCT00804843|O2|Outcome|Statin 10 mg|"Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will
receive 10 mg Atorvastatin."
529742|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
529743|NCT00804843|O2|Outcome|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
529744|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
529745|NCT00804843|E2|Reported Event|Statin 10 mg|"Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will
recieve 10 mg Atorvastatin."
529746|NCT00804843|E1|Reported Event|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will recieve 80 mg Atorvastatin + niacin
529747|NCT00804908|B4|Baseline|Total|Total of all reporting groups
529748|NCT00804908|B3|Baseline|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529749|NCT00804908|B2|Baseline|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529750|NCT00804908|B1|Baseline|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529751|NCT00804908|P3|Participant Flow|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529752|NCT00804908|P2|Participant Flow|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529753|NCT00804908|P1|Participant Flow|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529754|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529755|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529756|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529757|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529758|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529759|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529760|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529761|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529762|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529763|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529764|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529765|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529766|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529767|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529768|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529769|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529770|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529771|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529772|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529773|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529774|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529775|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529776|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529777|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529778|NCT00804908|E3|Reported Event|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529779|NCT00804908|E2|Reported Event|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529780|NCT00804908|E1|Reported Event|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
529781|NCT00804986|B7|Baseline|Total|Total of all reporting groups
529782|NCT00804986|B6|Baseline|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529783|NCT00804986|B5|Baseline|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529784|NCT00804986|B4|Baseline|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529785|NCT00804986|B3|Baseline|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529786|NCT00804986|B2|Baseline|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529787|NCT00804986|B1|Baseline|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529788|NCT00804986|P6|Participant Flow|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529789|NCT00804986|P5|Participant Flow|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529790|NCT00804986|P4|Participant Flow|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529791|NCT00804986|P3|Participant Flow|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529792|NCT00804986|P2|Participant Flow|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529793|NCT00804986|P1|Participant Flow|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529794|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529795|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529796|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529797|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529798|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529799|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529800|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529801|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529802|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529803|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529804|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529805|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529806|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529807|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529965|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
529808|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529809|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529810|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529811|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529812|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529813|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529814|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529815|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529816|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529817|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529818|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529819|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529820|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529821|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529822|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529823|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529824|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529825|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529826|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529827|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529828|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529829|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529830|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529831|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529832|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529833|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529834|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529835|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529836|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529837|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529838|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529839|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529840|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
539818|NCT00822354|O2|Outcome|Week 4 of Treatment|
529841|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529842|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529843|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529844|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529845|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529846|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529847|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529848|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529849|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529850|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529851|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529852|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529853|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529854|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529855|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529856|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529857|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529858|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529859|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529860|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529861|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529862|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529863|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529864|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529865|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529866|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529867|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529868|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529869|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529870|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529871|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529872|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529873|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
539819|NCT00822354|O1|Outcome|Pre-treatment|
529874|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529875|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529876|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529877|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529878|NCT00804986|E6|Reported Event|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529879|NCT00804986|E5|Reported Event|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529880|NCT00804986|E4|Reported Event|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529881|NCT00804986|E3|Reported Event|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529882|NCT00804986|E2|Reported Event|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529883|NCT00804986|E1|Reported Event|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
529884|NCT00805025|B1|Baseline|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
529885|NCT00805025|P1|Participant Flow|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of aztreonam for inhalation solution (AZLI) 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
529886|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
529887|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
529888|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
529889|NCT00805025|E1|Reported Event|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
529890|NCT00805038|B3|Baseline|Total|Total of all reporting groups
529891|NCT00805038|B2|Baseline|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
529892|NCT00805038|B1|Baseline|Usual Care|Usual care received by participants
529893|NCT00805038|P2|Participant Flow|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
529894|NCT00805038|P1|Participant Flow|Usual Care|Usual care received by participants
529895|NCT00805038|O2|Outcome|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
529896|NCT00805038|O1|Outcome|Usual Care|Usual care received by participants
529897|NCT00805038|E2|Reported Event|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
529898|NCT00805038|E1|Reported Event|Usual Care|Usual care received by participants
529899|NCT00805142|B3|Baseline|Total|Total of all reporting groups
529900|NCT00805142|B2|Baseline|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
529901|NCT00805142|B1|Baseline|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529966|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
529902|NCT00805142|P2|Participant Flow|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
529903|NCT00805142|P1|Participant Flow|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529904|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529905|NCT00805142|O1|Outcome|Opioid-Naive Participants Maintenance Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529906|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
529907|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529908|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
529909|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529928|NCT00805194|B1|Baseline|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529929|NCT00805194|P2|Participant Flow|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529967|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
540792|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
529910|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
529911|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529912|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
529913|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529914|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
529915|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529916|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
529930|NCT00805194|P1|Participant Flow|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529931|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529968|NCT00805285|E1|Reported Event|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
529917|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529918|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
529919|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529920|NCT00805142|O2|Outcome|Opioid-Switch Participants Titration Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Initial dose of tapentadol PR was selected according to the daily dose of opioid (morphine sustained release (SR) preparation, oxycodone hydrochloride (HCl) SR tablet or fentanyl patch). Equivalent dose of the tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day.
529921|NCT00805142|O1|Outcome|Opioid-Naive Participants Titration Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Treatment was initiated with tapentadol PR 25 mg oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day.
529922|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529923|NCT00805142|O1|Outcome|Opioid-Naive Participants Maintenance Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529924|NCT00805142|E2|Reported Event|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
529925|NCT00805142|E1|Reported Event|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
529926|NCT00805194|B3|Baseline|Total|Total of all reporting groups
529927|NCT00805194|B2|Baseline|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529963|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
529932|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529933|NCT00805194|O2|Outcome|Nintedanib 150 Bid mg Plus Docetaxel|Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529934|NCT00805194|O1|Outcome|Nitedanib 200 mg Bid Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529935|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529936|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529937|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529938|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529939|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529940|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529941|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529942|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529943|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 (with dose reduction to 60 mg/m2 if required) once every 3 weeks administered via intravenous infusion over 1 hour (h).
529944|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529945|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529946|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529947|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529948|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529949|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529950|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529951|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529952|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529953|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529954|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529955|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529956|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529957|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529958|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529959|NCT00805194|E2|Reported Event|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529960|NCT00805194|E1|Reported Event|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
529961|NCT00805285|B1|Baseline|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
529962|NCT00805285|P1|Participant Flow|Combination Oral Budesonide and Rectal Hydrocortisone|Budesonide 9 mg po daily and Rectal Hydrocortisone once daily
529969|NCT00805389|B6|Baseline|Total|Total of all reporting groups
529970|NCT00805389|B5|Baseline|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529971|NCT00805389|B4|Baseline|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529972|NCT00805389|B3|Baseline|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529973|NCT00805389|B2|Baseline|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529974|NCT00805389|B1|Baseline|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529975|NCT00805389|P5|Participant Flow|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529976|NCT00805389|P4|Participant Flow|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529977|NCT00805389|P3|Participant Flow|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529978|NCT00805389|P2|Participant Flow|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529979|NCT00805389|P1|Participant Flow|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529980|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529981|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530258|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
530259|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
529982|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529983|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529984|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529985|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529986|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529987|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529988|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529989|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529990|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529991|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529992|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529993|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530260|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
530261|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
529994|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529995|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529996|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529997|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529998|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
529999|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530000|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530001|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530002|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530003|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530004|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530005|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530262|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
530263|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
530006|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530007|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530008|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530009|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530010|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530011|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530012|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530013|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530014|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530015|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530016|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530017|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530264|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
530265|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
530018|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530019|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530020|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530021|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530022|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530023|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530024|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530025|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530026|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530027|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530028|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530029|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530030|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530031|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530032|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530033|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530034|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530035|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530036|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530037|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530038|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530039|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530040|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530041|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530042|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530043|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530266|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
530044|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530045|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530046|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530047|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530048|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530049|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530050|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530051|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530052|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530053|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530054|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530055|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530267|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
530268|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
541038|NCT00831675|B3|Baseline|Total|Total of all reporting groups
530056|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530057|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530058|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530059|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530060|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530061|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530062|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530063|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530064|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530065|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530066|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530067|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530081|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
541168|NCT00833027|B1|Baseline|Sitagliptin 100mg|
530068|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530069|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530070|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530071|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530072|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530073|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530074|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530075|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530076|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530077|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530078|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530079|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530080|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
530229|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
530082|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
530083|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530084|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530085|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530086|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530087|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530088|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530089|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530090|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530091|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530092|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530093|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530094|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530230|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
530231|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
530232|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
530095|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530096|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530097|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530098|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530099|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530100|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530101|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530102|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530103|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530104|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530105|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
530106|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
530107|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
530233|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
530108|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530109|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530110|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530111|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530112|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530113|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530114|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530115|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
530116|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
530117|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
530118|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530119|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530120|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
530121|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
530234|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
530235|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
530236|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
530122|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
530123|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530124|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530125|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530126|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530127|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530128|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530129|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530130|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530131|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530132|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530133|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530134|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530237|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
530238|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
530239|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
530240|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
530241|NCT00805467|E4|Reported Event|50 MG BID|
530242|NCT00805467|E3|Reported Event|150 MG QD|
530135|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530136|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530137|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530138|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530139|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530140|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530141|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530142|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530143|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530144|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530145|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530146|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530147|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530243|NCT00805467|E2|Reported Event|100 MG QD|
530244|NCT00805467|E1|Reported Event|100 MG BID|
530245|NCT00805480|B5|Baseline|Total|Total of all reporting groups
530246|NCT00805480|B4|Baseline|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
530148|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530149|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530150|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530151|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530152|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530153|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530154|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530155|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530156|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530157|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530158|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530159|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530160|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530247|NCT00805480|B3|Baseline|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
530248|NCT00805480|B2|Baseline|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
530161|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530162|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530163|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530164|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530165|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530166|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530167|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530168|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530169|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530170|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530171|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530172|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530249|NCT00805480|B1|Baseline|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
530250|NCT00805480|P4|Participant Flow|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
530251|NCT00805480|P3|Participant Flow|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
530173|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530174|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530175|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530176|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530177|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530178|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530179|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530180|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530181|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530182|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530183|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530184|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530252|NCT00805480|P2|Participant Flow|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
530253|NCT00805480|P1|Participant Flow|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
530185|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530186|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530187|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530188|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530189|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530190|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530191|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530192|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530193|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530194|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530195|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530196|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530254|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
530255|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
541169|NCT00833027|P1|Participant Flow|Sitagliptin 100mg|
530197|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530198|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530199|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530200|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530201|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530202|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530203|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530204|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530205|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530206|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530207|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530208|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530256|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
530257|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
530209|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530210|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530211|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530212|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530213|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530214|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530215|NCT00805389|E5|Reported Event|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530216|NCT00805389|E4|Reported Event|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530217|NCT00805389|E3|Reported Event|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530218|NCT00805389|E2|Reported Event|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530219|NCT00805389|E1|Reported Event|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
530220|NCT00805467|B5|Baseline|Total|Total of all reporting groups
530221|NCT00805467|B4|Baseline|Fostamatinib 100 mg Bid|Oral treatment
530222|NCT00805467|B3|Baseline|Fostamatinib 150 mg qd|Oral treatment
530223|NCT00805467|B2|Baseline|Fostamatinib 100 mg qd|Oral treatment
530224|NCT00805467|B1|Baseline|Fostamatinib 50 mg Bid|Oral treatment
530225|NCT00805467|P4|Participant Flow|Fostamatinib 100 mg Bid|Oral treatment
530226|NCT00805467|P3|Participant Flow|Fostamatinib 150 mg qd|Oral treatment
530227|NCT00805467|P2|Participant Flow|Fostamatinib 100 mg qd|Oral treatment
530228|NCT00805467|P1|Participant Flow|Fostamatinib 50 mg Bid|Oral treatment
530269|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
530270|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
530271|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
530272|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
530273|NCT00805480|E4|Reported Event|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
530274|NCT00805480|E3|Reported Event|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
530275|NCT00805480|E2|Reported Event|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
530276|NCT00805480|E1|Reported Event|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
530277|NCT00805493|B4|Baseline|Total|Total of all reporting groups
530278|NCT00805493|B3|Baseline|Not Randomized|
530279|NCT00805493|B2|Baseline|Placebo|
530280|NCT00805493|B1|Baseline|Riluzole|
530281|NCT00805493|P3|Participant Flow|Not Randomized|Those who withdrew prior to the decision to randomize
530282|NCT00805493|P2|Participant Flow|Placebo|Those randomized to receive placebo
530283|NCT00805493|P1|Participant Flow|Riluzole|Those randomized to riluzole
530284|NCT00805493|O3|Outcome|Riluzole|The group randomized to receive riluzole
530285|NCT00805493|O2|Outcome|Not Randomized|Participants who withdrew prior to the decision to randomize
530286|NCT00805493|O1|Outcome|Placebo|The group randomized to receive placebo
530287|NCT00805493|O3|Outcome|Not Randomized|Those who withdrew prior to the decision to randomize
530288|NCT00805493|O2|Outcome|Placebo|
530289|NCT00805493|O1|Outcome|Riluzole|The group randomized to riluzole
530290|NCT00805493|E3|Reported Event|Not Randomized|
530291|NCT00805493|E2|Reported Event|Placebo|
530292|NCT00805493|E1|Reported Event|Riluzole|
530293|NCT00805545|B3|Baseline|Total|Total of all reporting groups
530294|NCT00805545|B2|Baseline|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
530295|NCT00805545|B1|Baseline|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
530296|NCT00805545|P2|Participant Flow|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
530297|NCT00805545|P1|Participant Flow|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
530298|NCT00805545|O2|Outcome|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
530299|NCT00805545|O1|Outcome|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
530300|NCT00805545|E2|Reported Event|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
530301|NCT00805545|E1|Reported Event|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
530302|NCT00799903|B3|Baseline|Total|Total of all reporting groups
530303|NCT00799903|B2|Baseline|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
530304|NCT00799903|B1|Baseline|Placebo|Participants were randomized to receive matching placebo once daily.
530305|NCT00799903|P2|Participant Flow|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
530306|NCT00799903|P1|Participant Flow|Placebo|Participants were randomized to receive matching placebo once daily.
530307|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
530308|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
530309|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
530310|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
530311|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
530312|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
530313|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
530314|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
530315|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
530316|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
530317|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
530318|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
530319|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
530320|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
530321|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
530322|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
530323|NCT00799903|E2|Reported Event|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
530324|NCT00799903|E1|Reported Event|Placebo|Participants were randomized to receive matching placebo once daily.
530325|NCT00800202|B3|Baseline|Total|Total of all reporting groups
530453|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
530326|NCT00800202|B2|Baseline|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
530327|NCT00800202|B1|Baseline|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
530328|NCT00800202|P2|Participant Flow|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib150 milligrams per day (mg/day) administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
530329|NCT00800202|P1|Participant Flow|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 milligrams per square meter (mg/m^2) iv every 3 weeks for 6 cycles and carboplatin Area Under Curve (AUC) 6.0 milligrams per milliliter per minute (mg/mL/min) iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
530330|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
530331|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
530332|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
530333|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
530334|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
530335|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
530336|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
530337|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
530338|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
530339|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
530340|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
530341|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
530342|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
530343|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
530344|NCT00800202|E2|Reported Event|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
530345|NCT00800202|E1|Reported Event|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
530346|NCT00800254|B3|Baseline|Total|Total of all reporting groups
530454|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
530347|NCT00800254|B2|Baseline|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
530348|NCT00800254|B1|Baseline|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
530349|NCT00800254|P2|Participant Flow|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
530350|NCT00800254|P1|Participant Flow|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
530351|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
530352|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
530353|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
530354|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
530355|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
530356|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
530357|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
530358|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
530359|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
530360|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
530361|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
530362|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
530363|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
530364|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
530365|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
530366|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
530367|NCT00800254|E2|Reported Event|Standard Rehabilitation Protocol|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
530368|NCT00800254|E1|Reported Event|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
530369|NCT00805675|B4|Baseline|Total|Total of all reporting groups
530370|NCT00805675|B3|Baseline|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530371|NCT00805675|B2|Baseline|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530372|NCT00805675|B1|Baseline|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530373|NCT00805675|P3|Participant Flow|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530408|NCT00805740|B1|Baseline|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530374|NCT00805675|P2|Participant Flow|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530375|NCT00805675|P1|Participant Flow|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530376|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530377|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530378|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530379|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530380|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530381|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530382|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530383|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530384|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
541170|NCT00833027|O1|Outcome|Sitagliptin 100mg|
530385|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530386|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530387|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530388|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530389|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530390|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530391|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530392|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530393|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530394|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530395|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530396|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530397|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530398|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530399|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530400|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530401|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530402|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530403|NCT00805675|E3|Reported Event|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530404|NCT00805675|E2|Reported Event|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530405|NCT00805675|E1|Reported Event|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
530406|NCT00805740|B3|Baseline|Total|Total of all reporting groups
530407|NCT00805740|B2|Baseline|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530447|NCT00805870|B2|Baseline|Control|Wheat Germ Oil, 3 grams/day for 65 days
530448|NCT00805870|B1|Baseline|Fish Oil|Lovaza, 3 grams/day for 65 days
530409|NCT00805740|P2|Participant Flow|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530410|NCT00805740|P1|Participant Flow|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530411|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530412|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530413|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530414|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530415|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530416|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530417|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530418|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530419|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530420|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530421|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530422|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530449|NCT00805870|P2|Participant Flow|Control|Wheat Germ Oil, 3 grams/day for 65 days
530450|NCT00805870|P1|Participant Flow|Fish Oil|Lovaza, 3 grams/day for 65 days
530451|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
530423|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530424|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530425|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530426|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530427|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530428|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530429|NCT00805740|E2|Reported Event|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530430|NCT00805740|E1|Reported Event|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
530431|NCT00805766|B1|Baseline|TA-650|
530432|NCT00805766|P1|Participant Flow|TA-650|"Screening period: From the beginning of TA-650 5 mg/kg administration to the beginning of TA-650 10 mg/kg administration in the increased dose period in order to confirm that the effects of treatment with TA-650 5 mg/kg at 8-week intervals were insufficient. The screening period was to be up to 16 weeks. Patients who did not satisfy the dose-increasing criteria discontinued study treatment.Patients who discontinued study treatment during the screening period were to be evaluated until withdrawal.
Increased dose period: From the beginning of administration of TA-650 10 mg/kg to evaluation at week 40. Patients who discontinued study treatment during the increased dose period were to be evaluated until withdrawal."
530433|NCT00805766|O1|Outcome|TA-650|
530434|NCT00805766|O1|Outcome|TA-650|
530435|NCT00805766|E3|Reported Event|Increased Dose Period|
530436|NCT00805766|E2|Reported Event|Screening Period|
530437|NCT00805766|E1|Reported Event|Entire Evaluation Period|Screening Period + Increased Dose Period
530438|NCT00805792|B1|Baseline|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
530439|NCT00805792|P1|Participant Flow|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
530440|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
530441|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
530442|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
530443|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
530444|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
530445|NCT00805792|E1|Reported Event|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
530446|NCT00805870|B3|Baseline|Total|Total of all reporting groups
530455|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
530456|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
530457|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
530458|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
530459|NCT00805870|E2|Reported Event|Control|Wheat Germ Oil, 3 grams/day for 65 days
530460|NCT00805870|E1|Reported Event|Fish Oil|Lovaza, 3 grams/day for 65 days
530461|NCT00805935|B5|Baseline|Total|Total of all reporting groups
530462|NCT00805935|B4|Baseline|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530463|NCT00805935|B3|Baseline|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530464|NCT00805935|B2|Baseline|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530465|NCT00805935|B1|Baseline|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530466|NCT00805935|P4|Participant Flow|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530467|NCT00805935|P3|Participant Flow|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530468|NCT00805935|P2|Participant Flow|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530469|NCT00805935|P1|Participant Flow|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530470|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530471|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530472|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530473|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530474|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530475|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530476|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530531|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
541171|NCT00833027|O1|Outcome|Sitagliptin 100mg|
530477|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530478|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530479|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530480|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530481|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530482|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530483|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530484|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530485|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530486|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530487|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530488|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530489|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530490|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530491|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530492|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530493|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530572|NCT00807885|P8|Participant Flow|Tape-secured 20 ga Polyurethane Catheter|
530494|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530495|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530496|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530497|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530498|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530499|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530500|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530501|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530502|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
530503|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
530504|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
530505|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
530506|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
530507|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
530508|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
530509|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
530532|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530510|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
530511|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
530512|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530513|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530514|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530515|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530516|NCT00805935|E4|Reported Event|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530517|NCT00805935|E3|Reported Event|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530518|NCT00805935|E2|Reported Event|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530519|NCT00805935|E1|Reported Event|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
530520|NCT00805961|B1|Baseline|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
530521|NCT00805961|P1|Participant Flow|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
530522|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
530523|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
530524|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
530525|NCT00805961|E1|Reported Event|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
530526|NCT00807846|B3|Baseline|Total|Total of all reporting groups
530527|NCT00807846|B2|Baseline|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530528|NCT00807846|B1|Baseline|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530529|NCT00807846|P2|Participant Flow|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530530|NCT00807846|P1|Participant Flow|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530567|NCT00807885|B4|Baseline|Tape-secured 24 ga Polyurethane Catheter|
530568|NCT00807885|B3|Baseline|Tegaderm-secured 24 ga Polyurethane Catheter|
530533|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530534|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530535|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530536|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530537|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530538|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530539|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530540|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530541|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530542|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530543|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530544|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530545|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530546|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530547|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530548|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530549|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530550|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530551|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530552|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530553|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530554|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530555|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530556|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530557|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530558|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530559|NCT00807846|E2|Reported Event|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530560|NCT00807846|E1|Reported Event|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
530561|NCT00807885|B10|Baseline|Total|Total of all reporting groups
530562|NCT00807885|B9|Baseline|SC Button With 27 ga X 9 mm Needle|
530563|NCT00807885|B8|Baseline|Tape-secured 20 ga Polyurethane Catheter|
530564|NCT00807885|B7|Baseline|Tegaderm-secured 20 ga Polyurethane Catheter|
530565|NCT00807885|B6|Baseline|Tape-secured 20 ga Teflon Catheter|
530566|NCT00807885|B5|Baseline|Tegaderm-secured 20 ga Teflon Catheter|
530573|NCT00807885|P7|Participant Flow|Tegaderm-secured 20 ga Polyurethane Catheter|
530574|NCT00807885|P6|Participant Flow|Tape-secured 20 ga Teflon Catheter|
530575|NCT00807885|P5|Participant Flow|Tegaderm-secured 20 ga Teflon Catheter|
530576|NCT00807885|P4|Participant Flow|Tape-secured 24 ga Polyurethane Catheter|
530577|NCT00807885|P3|Participant Flow|Tegaderm-secured 24 ga Polyurethane Catheter|
530578|NCT00807885|P2|Participant Flow|Tape-secured 24 ga Teflon Catheter|
530579|NCT00807885|P1|Participant Flow|Tegaderm-secured 24 ga Teflon Catheter|
530580|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
530581|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
530582|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
530583|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
530584|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
530585|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
530586|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
530587|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
530588|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
530589|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
530590|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
530591|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
530592|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
530593|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
530594|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
530595|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
530596|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
530597|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
530598|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
530599|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
530600|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
530601|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
530602|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
530603|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
530604|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
530605|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
530606|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
530607|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
530608|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
530609|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
530610|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
530611|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
530612|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
530613|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
530614|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
530615|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
530616|NCT00807885|E9|Reported Event|SC Button With 27 ga X 9 mm Needle|
530617|NCT00807885|E8|Reported Event|Tape-secured 20 ga Polyurethane Catheter|
530618|NCT00807885|E7|Reported Event|Tegaderm-secured 20 ga Polyurethane Catheter|
530619|NCT00807885|E6|Reported Event|Tape-secured 20 ga Teflon Catheter|
530620|NCT00807885|E5|Reported Event|Tegaderm-secured 20 ga Teflon Catheter|
530621|NCT00807885|E4|Reported Event|Tape-secured 24 ga Polyurethane Catheter|
530622|NCT00807885|E3|Reported Event|Tegaderm-secured 24 ga Polyurethane Catheter|
530623|NCT00807885|E2|Reported Event|Tape-secured 24 ga Teflon Catheter|
530624|NCT00807885|E1|Reported Event|Tegaderm-secured 24 ga Teflon Catheter|
530625|NCT00807937|B5|Baseline|Total|Total of all reporting groups
530626|NCT00807937|B4|Baseline|Placebo|Placebo
530627|NCT00807937|B3|Baseline|Lorazepam|Lorazepam 2 mg twice daily (BID)
530628|NCT00807937|B2|Baseline|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
530629|NCT00807937|B1|Baseline|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
530630|NCT00807937|P4|Participant Flow|Placebo|Placebo
530631|NCT00807937|P3|Participant Flow|Lorazepam|Lorazepam 2 mg twice daily (BID)
530632|NCT00807937|P2|Participant Flow|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
530633|NCT00807937|P1|Participant Flow|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
530634|NCT00807937|O4|Outcome|Placebo|Placebo
530635|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
530636|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
530637|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
530638|NCT00807937|O4|Outcome|Placebo|Placebo
530639|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
530640|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
530641|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
530642|NCT00807937|O4|Outcome|Placebo|Placebo
530643|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
530644|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
530645|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
530646|NCT00807937|O4|Outcome|Placebo|Placebo
530647|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
530648|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
530649|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
530650|NCT00807937|O4|Outcome|Placebo|Placebo
530651|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
530652|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
530653|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
530654|NCT00807937|E4|Reported Event|Placebo|Placebo
530655|NCT00807937|E3|Reported Event|Lorazepam|Lorazepam 2 mg twice daily (BID)
530656|NCT00807937|E2|Reported Event|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
530657|NCT00807937|E1|Reported Event|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
530658|NCT00807989|B3|Baseline|Total|Total of all reporting groups
530659|NCT00807989|B2|Baseline|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate"
530660|NCT00807989|B1|Baseline|Carbamazepine|"Carbamazepine
Carbamazepine"
530661|NCT00807989|P2|Participant Flow|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy
Lamotrigine 25mg/day for the first two weeks. At next two weeks, LTG 50 mg once a day"
530662|NCT00807989|P1|Participant Flow|Carbamazepine|Carbamazepine 100mg/day for the first two weeks. At next two weeks, dose of Carbamazepine was increased to 200mg/day in two divided doses
530663|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate"
530664|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine
Carbamazepine"
530665|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate"
530666|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine
Carbamazepine"
530667|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate"
530668|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine
Carbamazepine"
530669|NCT00807989|E2|Reported Event|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate"
530670|NCT00807989|E1|Reported Event|Carbamazepine|"Carbamazepine
Carbamazepine"
530671|NCT00808015|B1|Baseline|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530672|NCT00808015|P1|Participant Flow|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530673|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530674|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530675|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530676|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530677|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530678|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530679|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530680|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530681|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530682|NCT00808015|E1|Reported Event|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
530683|NCT00808028|B5|Baseline|Total|Total of all reporting groups
530684|NCT00808028|B4|Baseline|rLP2086 200 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530685|NCT00808028|B3|Baseline|rLP2086 120 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530686|NCT00808028|B2|Baseline|rLP2086 60 mcg|Given on a 0, 2-, 6-month schedule in Stage 1.
530687|NCT00808028|B1|Baseline|Control|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530688|NCT00808028|P4|Participant Flow|rLP2086 200 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530689|NCT00808028|P3|Participant Flow|rLP2086 120 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530690|NCT00808028|P2|Participant Flow|rLP2086 60 Microgram (mcg)|Given on a 0, 2-, 6-month schedule in Stage 1
530691|NCT00808028|P1|Participant Flow|Control|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530692|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530693|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530694|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
530695|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530696|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530697|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530698|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
530699|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530700|NCT00808028|O3|Outcome|rLP2086 200 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
530701|NCT00808028|O2|Outcome|rLP2086 120 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
530702|NCT00808028|O1|Outcome|Control- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
530703|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530704|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530705|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
530706|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530707|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530708|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530709|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
530710|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530711|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530712|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530713|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
530714|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
530715|NCT00808028|E11|Reported Event|rLP2086 200 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
530716|NCT00808028|E10|Reported Event|rLP2086 120 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
530717|NCT00808028|E9|Reported Event|Control-Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
530718|NCT00808028|E8|Reported Event|rLP2086 200 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
530719|NCT00808028|E7|Reported Event|rLP2086 120 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
530720|NCT00808028|E6|Reported Event|rLP2086 60 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
530721|NCT00808028|E5|Reported Event|Control-Stage 1 Follow-up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
530722|NCT00808028|E4|Reported Event|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
530723|NCT00808028|E3|Reported Event|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
530724|NCT00808028|E2|Reported Event|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
530725|NCT00808028|E1|Reported Event|Control- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
530726|NCT00808067|B3|Baseline|Total|Total of all reporting groups
530727|NCT00808067|B2|Baseline|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530728|NCT00808067|B1|Baseline|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530729|NCT00808067|P2|Participant Flow|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530730|NCT00808067|P1|Participant Flow|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530731|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530732|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530733|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530734|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530735|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530736|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530737|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530738|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530739|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530740|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530741|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530742|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530743|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530744|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530745|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530746|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530747|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530748|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530749|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530750|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530751|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530752|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530753|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530754|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530755|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530756|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530757|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530758|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530759|NCT00808067|E2|Reported Event|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
530760|NCT00808067|E1|Reported Event|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
530761|NCT00808080|B1|Baseline|Biologic|"AML_CTL cells
AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)"
530855|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530762|NCT00808080|P1|Participant Flow|Biologic|"AML_CTL cells
AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)
6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
530763|NCT00808080|O1|Outcome|Biologic|"AML_CTL cells
AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)
6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
530764|NCT00808080|E1|Reported Event|Biologic|"AML_CTL cells
AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)
6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
530765|NCT00808132|B6|Baseline|Total|Total of all reporting groups
530766|NCT00808132|B5|Baseline|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530767|NCT00808132|B4|Baseline|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530768|NCT00808132|B3|Baseline|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530769|NCT00808132|B2|Baseline|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530770|NCT00808132|B1|Baseline|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530771|NCT00808132|P5|Participant Flow|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530772|NCT00808132|P4|Participant Flow|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530773|NCT00808132|P3|Participant Flow|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530774|NCT00808132|P2|Participant Flow|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530775|NCT00808132|P1|Participant Flow|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530776|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530777|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530778|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530779|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530780|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530781|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530782|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530783|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530784|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530785|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530786|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530787|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530788|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530789|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530790|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530791|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530856|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530792|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530793|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530794|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530795|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530796|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530797|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530798|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530799|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530800|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530801|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530802|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530803|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530804|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530805|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530806|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530807|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530808|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530809|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530810|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530811|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530812|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530813|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530814|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530815|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530816|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530817|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530818|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530819|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530820|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530821|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
541172|NCT00833027|E1|Reported Event|Sitagliptin 100mg|
530822|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530823|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530824|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530825|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530826|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530827|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530828|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530829|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530830|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530831|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530832|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530833|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530834|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530835|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530836|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530837|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530838|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530839|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530840|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530841|NCT00808132|E5|Reported Event|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530842|NCT00808132|E4|Reported Event|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530843|NCT00808132|E3|Reported Event|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530844|NCT00808132|E2|Reported Event|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530845|NCT00808132|E1|Reported Event|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
530846|NCT00808236|B3|Baseline|Total|Total of all reporting groups
530847|NCT00808236|B2|Baseline|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530848|NCT00808236|B1|Baseline|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530849|NCT00808236|P2|Participant Flow|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530850|NCT00808236|P1|Participant Flow|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530851|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530852|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530853|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530854|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
532018|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
530857|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530858|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530859|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530860|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530861|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530862|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530863|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530864|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530865|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530866|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530867|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530868|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530869|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530870|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530871|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530872|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530873|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530874|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530875|NCT00808236|E2|Reported Event|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
530876|NCT00808236|E1|Reported Event|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
530877|NCT00808249|B5|Baseline|Total|Total of all reporting groups
530878|NCT00808249|B4|Baseline|D-Placebo|Placebo
530879|NCT00808249|B3|Baseline|C-AZD7325 10 mg|AZD7325 10 mg QD
530880|NCT00808249|B2|Baseline|B-AZD7325 5 mg|AZD7325 5 mg BID
530881|NCT00808249|B1|Baseline|A-AZD7325 2 mg|AZD7325 2 mg BID
530882|NCT00808249|P4|Participant Flow|D-Placebo|Placebo
530883|NCT00808249|P3|Participant Flow|C-AZD7325 10 mg|AZD7325 10 mg QD
530884|NCT00808249|P2|Participant Flow|B-AZD7325 5 mg|AZD7325 5 mg BID
530885|NCT00808249|P1|Participant Flow|A-AZD7325 2 mg|AZD7325 2 mg BID
530886|NCT00808249|O4|Outcome|D-Placebo|Placebo
530887|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
530888|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
530889|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
530890|NCT00808249|O4|Outcome|D-Placebo|Placebo
530891|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
530892|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
530893|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
530894|NCT00808249|O4|Outcome|D-Placebo|Placebo
530895|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
530896|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
530897|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
530898|NCT00808249|O4|Outcome|D-Placebo|Placebo
530899|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
530900|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
530901|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
530902|NCT00808249|O4|Outcome|D-Placebo|Placebo
530903|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
530904|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
530905|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
530906|NCT00808249|E4|Reported Event|D-Placebo|Placebo
530907|NCT00808249|E3|Reported Event|C-AZD7325 10 mg|AZD7325 10 mg QD
530908|NCT00808249|E2|Reported Event|B-AZD7325 5 mg|AZD7325 5 mg BID
530909|NCT00808249|E1|Reported Event|A-AZD7325 2 mg|AZD7325 2 mg BID
530910|NCT00808340|B1|Baseline|Overall|
530911|NCT00808340|P6|Participant Flow|Balafilcon A/Senofilcon A Prod/Senofilcon A Test|Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A producton worn second, senofilcon A test worn third.
530912|NCT00808340|P5|Participant Flow|Balafilcon A/Senofilcon A Test/Senofilcon A Prod|Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
530913|NCT00808340|P4|Participant Flow|Senofilcon A Prod/ Balifilcon A/ Senofilcon A Test|Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, balafilcon A worn second, and senofilcon A test worn third.
530914|NCT00808340|P3|Participant Flow|Senofilcon A Prod/Senofilcon A Test/Balafilcon A|Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, senofilcon A test worn second, and balafilcon A worn third.
530915|NCT00808340|P2|Participant Flow|Senofilcon A Test/Balafilcon A/Senofilcon A Prod|Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
532019|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
530916|NCT00808340|P1|Participant Flow|Senofilcon A Test/Senofilcon A Prod/Balafilcon A|Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
530917|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
530918|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
530919|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
530920|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
530921|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
530922|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
530923|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
530924|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
530925|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
530926|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
530927|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
530928|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
530929|NCT00808340|E3|Reported Event|Balafilcon A|
530930|NCT00808340|E2|Reported Event|Senofilcon A Prod|
530931|NCT00808340|E1|Reported Event|Senofilcon A Test|
530932|NCT00808405|B3|Baseline|Total|Total of all reporting groups
530933|NCT00808405|B2|Baseline|Placebo|Matching placebo tablet
530934|NCT00808405|B1|Baseline|Acyclovir|Acyclovir 400 mg orally three times daily
530935|NCT00808405|P2|Participant Flow|Placebo|Matching placebo tablet
530936|NCT00808405|P1|Participant Flow|Acyclovir|Acyclovir 400 mg orally three times daily
530937|NCT00808405|O2|Outcome|Placebo|Matching placebo tablet
530938|NCT00808405|O1|Outcome|Acyclovir|Acyclovir 400 mg orally three times daily
530939|NCT00808405|O2|Outcome|Placebo|Matching placebo tablet
530940|NCT00808405|O1|Outcome|Acyclovir|Acyclovir 400 mg orally three times daily
530941|NCT00808405|E2|Reported Event|Placebo|Matching placebo tablet
530942|NCT00808405|E1|Reported Event|Acyclovir|Acyclovir 400 mg orally three times daily
530943|NCT00808444|B3|Baseline|Total|Total of all reporting groups
530944|NCT00808444|B2|Baseline|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530945|NCT00808444|B1|Baseline|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530946|NCT00808444|P2|Participant Flow|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530947|NCT00808444|P1|Participant Flow|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530948|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530949|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530950|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
531046|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
530951|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530952|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530953|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530954|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530955|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530956|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530957|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530958|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530959|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530960|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530961|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530962|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530963|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530964|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
531161|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
531445|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
530965|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530966|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530967|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530968|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530969|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530970|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530971|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530972|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530973|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530974|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530975|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530976|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530977|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530978|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
531162|NCT00808808|E3|Reported Event|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
530979|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530980|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530981|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530982|NCT00808444|E2|Reported Event|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530983|NCT00808444|E1|Reported Event|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
530984|NCT00808470|B3|Baseline|Total|Total of all reporting groups
530985|NCT00808470|B2|Baseline|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.
Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
530986|NCT00808470|B1|Baseline|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.
Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily
total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
530987|NCT00808470|P2|Participant Flow|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.
Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
530988|NCT00808470|P1|Participant Flow|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.
Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily
total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
530989|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.
Placebo: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
530990|NCT00808470|O1|Outcome|Nutrients|"beta-carotene, vitamins C and E, magnesium
beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily
total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
530991|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.
Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
530992|NCT00808470|O1|Outcome|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.
Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily
total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
530993|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in UF music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.
Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
530994|NCT00808470|O1|Outcome|Nutrients|"Dietary Supplement. Subjects in UF music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.
Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily
total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
530995|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.
Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
530996|NCT00808470|O1|Outcome|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.
Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily
total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
530997|NCT00808470|E2|Reported Event|Placebo for Nutrients|"Subjects in UF music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.
Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
530998|NCT00808470|E1|Reported Event|Nutrients|"Dietary Supplement. Subjects in UF music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.
Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily
total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
530999|NCT00808483|B3|Baseline|Total|Total of all reporting groups
531000|NCT00808483|B2|Baseline|Control Group|No participation in the walking skill training group
531001|NCT00808483|B1|Baseline|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.
Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and sit-to-stand with guidance and supervision from a physiotherapist."
531002|NCT00808483|P2|Participant Flow|Control Group|No participation in the walking skill training group
531003|NCT00808483|P1|Participant Flow|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.
Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
531004|NCT00808483|O2|Outcome|Control Group|No session of participation in the walking skill training program
531005|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
531006|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
531007|NCT00808483|O1|Outcome|Walking Skilll Training Group|12 sessions of participation in the supervised walking skilll training program
531008|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
531009|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
531010|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
531011|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
531012|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
531013|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training group
531014|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
531015|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in a supervised walking skill training program
531016|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
531017|NCT00808483|O1|Outcome|Walking Skill Training Group|12 session of participation in the supervised walking skill training program
531018|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
531019|NCT00808483|O1|Outcome|Walking Skill Training Group|"12 sessions of participation in the supervised walking skill training program.
Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
531020|NCT00808483|E2|Reported Event|Control Group|No participation in the walking skill training group
531021|NCT00808483|E1|Reported Event|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.
Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
531022|NCT00808509|B3|Baseline|Total|Total of all reporting groups
531023|NCT00808509|B2|Baseline|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531024|NCT00808509|B1|Baseline|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531025|NCT00808509|P2|Participant Flow|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531026|NCT00808509|P1|Participant Flow|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531027|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531028|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531029|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531030|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531031|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531032|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531033|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531034|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531035|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531036|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531037|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531038|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531039|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531040|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531041|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531042|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531043|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531044|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531045|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
532020|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
531047|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531048|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531049|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531050|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531051|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531052|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531053|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531054|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531055|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531056|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531057|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531058|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531059|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531060|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531061|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531062|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531063|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531064|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531065|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
532021|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
531066|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531067|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531068|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531069|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531070|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531071|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531072|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531073|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531074|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531075|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531076|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531077|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531078|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531079|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531080|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531081|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531082|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531083|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531084|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531220|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
531085|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531086|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531087|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531088|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531089|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531090|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531091|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531092|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531093|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531094|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531095|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531096|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531097|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531098|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531099|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531100|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531101|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531102|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531103|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
532022|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
531104|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531105|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531106|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531107|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531108|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531109|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531110|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531111|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531112|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531113|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531114|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531115|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531116|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531117|NCT00808509|E4|Reported Event|Methotrexate-Including Rescue|Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531118|NCT00808509|E3|Reported Event|Methotrexate-Rescue Arm|Participants received methotrexate alone for 52 weeks, but due to an increase in disease activity were reinstituted with adalimumab 40 mg subcutaneously every other week during the 52-week randomized period. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531119|NCT00808509|E2|Reported Event|Methotrexate-Excluding Rescue|Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks and were not reinstituted to adalimumab as rescue treatment. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531120|NCT00808509|E1|Reported Event|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
531121|NCT00808639|B1|Baseline|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes
Doxorubicin: intravenously 30mg/ms over 15 minutes
vinblastine: intravenously 3mg/m2 over 30 minutes
cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
531122|NCT00808639|P1|Participant Flow|Dose Dense MVAC|Dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC)
531123|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes
Doxorubicin: intravenously 30mg/ms over 15 minutes
vinblastine: intravenously 3mg/m2 over 30 minutes
cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
543560|NCT00837876|E1|Reported Event|Treatment|Sorafenib + Erlotinib
531124|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes
Doxorubicin: intravenously 30mg/ms over 15 minutes
vinblastine: intravenously 3mg/m2 over 30 minutes
cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
531125|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes
Doxorubicin: intravenously 30mg/ms over 15 minutes
vinblastine: intravenously 3mg/m2 over 30 minutes
cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
531126|NCT00808639|E1|Reported Event|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes
Doxorubicin: intravenously 30mg/ms over 15 minutes
vinblastine: intravenously 3mg/m2 over 30 minutes
cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
531127|NCT00808769|B1|Baseline|All Study Participants|
531128|NCT00808769|P2|Participant Flow|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
531129|NCT00808769|P1|Participant Flow|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
531130|NCT00808769|O2|Outcome|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
531131|NCT00808769|O1|Outcome|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
531132|NCT00808769|E2|Reported Event|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
531133|NCT00808769|E1|Reported Event|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
531134|NCT00808808|B4|Baseline|Total|Total of all reporting groups
531135|NCT00808808|B3|Baseline|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
531136|NCT00808808|B2|Baseline|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
531137|NCT00808808|B1|Baseline|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
531138|NCT00808808|P3|Participant Flow|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
531139|NCT00808808|P2|Participant Flow|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
531140|NCT00808808|P1|Participant Flow|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
531141|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as male.
531142|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as male.
531143|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as college graduates.
531144|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as college graduates.
531145|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as white.
531146|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as white
531147|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
531148|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
531149|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
531150|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
531151|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
531152|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
531153|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
531154|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
531155|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
531156|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
531157|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
531158|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
531159|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
531160|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
531163|NCT00808808|E2|Reported Event|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
531164|NCT00808808|E1|Reported Event|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
531165|NCT00808834|B1|Baseline|Overall|This reporting group includes all enrolled and exposed subjects.
531166|NCT00808834|P2|Participant Flow|Lotrafilcon A / Senofilcon A|Lotrafilcon A, followed by Senofilcon A
531167|NCT00808834|P1|Participant Flow|Senofilcon A / Lotrafilcon A|Senofilcon A, followed by Lotrafilcon A
531168|NCT00808834|O2|Outcome|Lotrafilcon A|Investigational, silicone hydrogel, spherical, soft contact lens
531169|NCT00808834|O1|Outcome|Senofilcon A|Commercially marketed, silicone hydrogel, spherical, soft contact lens
531170|NCT00808834|E2|Reported Event|Lotrafilcon A|Investigational, silicone hydrogel, spherical, soft contact lens
531171|NCT00808834|E1|Reported Event|Senofilcon A|Commercially marketed, silicone hydrogel, spherical, soft contact lens
531172|NCT00808899|B1|Baseline|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
531173|NCT00808899|P1|Participant Flow|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
531174|NCT00808899|O1|Outcome|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
531175|NCT00808899|E1|Reported Event|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
531176|NCT00809055|B3|Baseline|Total|Total of all reporting groups
531177|NCT00809055|B2|Baseline|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531178|NCT00809055|B1|Baseline|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531179|NCT00809055|P2|Participant Flow|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531180|NCT00809055|P1|Participant Flow|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531181|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531182|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531183|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531184|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531185|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531186|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531187|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531188|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531189|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531190|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531191|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531446|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531192|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531193|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531194|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531195|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531196|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531197|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531198|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531199|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531200|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531201|NCT00809055|E2|Reported Event|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531202|NCT00809055|E1|Reported Event|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.
Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
531203|NCT00809094|B3|Baseline|Total|Total of all reporting groups
531204|NCT00809094|B2|Baseline|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
531205|NCT00809094|B1|Baseline|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
531206|NCT00809094|P2|Participant Flow|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
531207|NCT00809094|P1|Participant Flow|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
531208|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
531209|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
531210|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
531211|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
531212|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
531213|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
531214|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
531215|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
531216|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
531217|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
531218|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
531219|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
532023|NCT00810303|E5|Reported Event|Ezetimibe and Efavirenz Multiple Dose|
531221|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
531222|NCT00809094|E2|Reported Event|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
531223|NCT00809094|E1|Reported Event|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
531224|NCT00809133|B15|Baseline|Total|Total of all reporting groups
531225|NCT00809133|B14|Baseline|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531226|NCT00809133|B13|Baseline|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531227|NCT00809133|B12|Baseline|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531228|NCT00809133|B11|Baseline|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531229|NCT00809133|B10|Baseline|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531230|NCT00809133|B9|Baseline|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531231|NCT00809133|B8|Baseline|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531232|NCT00809133|B7|Baseline|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531233|NCT00809133|B6|Baseline|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531234|NCT00809133|B5|Baseline|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531235|NCT00809133|B4|Baseline|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531236|NCT00809133|B3|Baseline|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531237|NCT00809133|B2|Baseline|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531238|NCT00809133|B1|Baseline|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531239|NCT00809133|P14|Participant Flow|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531240|NCT00809133|P13|Participant Flow|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531241|NCT00809133|P12|Participant Flow|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531242|NCT00809133|P11|Participant Flow|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531243|NCT00809133|P10|Participant Flow|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531244|NCT00809133|P9|Participant Flow|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531447|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531245|NCT00809133|P8|Participant Flow|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531246|NCT00809133|P7|Participant Flow|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531247|NCT00809133|P6|Participant Flow|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531248|NCT00809133|P5|Participant Flow|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531249|NCT00809133|P4|Participant Flow|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531250|NCT00809133|P3|Participant Flow|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531251|NCT00809133|P2|Participant Flow|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531252|NCT00809133|P1|Participant Flow|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531253|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531254|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531255|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531256|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531257|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531258|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531259|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531260|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531261|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531262|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531263|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531264|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531265|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531266|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531448|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531267|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531268|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531269|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531270|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531271|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531272|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531273|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531274|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531275|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531276|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531277|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531278|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531279|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531280|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531281|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531282|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531283|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531284|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531285|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531286|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531287|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531288|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531401|NCT00809133|E2|Reported Event|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531289|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531290|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531291|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531292|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531293|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531294|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531295|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531296|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531297|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531298|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531299|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531300|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531301|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531302|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531303|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531304|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531305|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531306|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531307|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531308|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531309|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531310|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531449|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531311|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531312|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531313|NCT00809133|O2|Outcome|Part B: End of 2nd Infusion of Cycle 1|Dose escalation of Bevacizumab administered as intravenous infusion to 5 mg/kg. Bevacizumab administered on Days 1 and 15 of a 28-day cycle.
531314|NCT00809133|O1|Outcome|Part B: End of 1st Infusion of Cycle 1|Dose escalation of Bevacizumab administered as intravenous infusion to 5 mg/kg. Bevacizumab administered on Days 1 and 15 of a 28-day cycle.
531315|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531316|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531317|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531318|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531319|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531320|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531321|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531322|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531323|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531324|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531325|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531326|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531327|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531328|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531329|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531330|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531331|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531402|NCT00809133|E1|Reported Event|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531332|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531333|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531334|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531335|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531336|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531337|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531338|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531339|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531340|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531341|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531342|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531343|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531344|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531345|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531346|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531347|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531348|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531349|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531350|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531351|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531352|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531353|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531354|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531355|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531403|NCT00809146|B3|Baseline|Total|Total of all reporting groups
531356|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531357|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531358|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531359|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531360|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531361|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531362|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531363|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531364|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531365|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531366|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531367|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531368|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531369|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531370|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531371|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531372|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531373|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531374|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531375|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531376|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531377|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531378|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
543561|NCT00837967|B1|Baseline|All Study Participants|
531379|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531380|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531381|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531382|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531383|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531384|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531385|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531386|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531387|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531388|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531389|NCT00809133|E14|Reported Event|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531390|NCT00809133|E13|Reported Event|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531391|NCT00809133|E12|Reported Event|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531392|NCT00809133|E11|Reported Event|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
531393|NCT00809133|E10|Reported Event|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531394|NCT00809133|E9|Reported Event|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
531395|NCT00809133|E8|Reported Event|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531396|NCT00809133|E7|Reported Event|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531397|NCT00809133|E6|Reported Event|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531398|NCT00809133|E5|Reported Event|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531399|NCT00809133|E4|Reported Event|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
531400|NCT00809133|E3|Reported Event|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
531681|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531404|NCT00809146|B2|Baseline|Intravenous (IV) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
531405|NCT00809146|B1|Baseline|Intramuscular (IM) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
531406|NCT00809146|P2|Participant Flow|Intravenous (IV) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
531407|NCT00809146|P1|Participant Flow|Intramuscular (IM) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
531408|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
531409|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
531410|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
531411|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
531412|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
531413|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
531414|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
531415|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
531416|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
531417|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
531418|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
531419|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
531420|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
531421|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
531422|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
531423|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
531424|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
531425|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
531426|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
531427|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
531428|NCT00809146|E2|Reported Event|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
531429|NCT00809146|E1|Reported Event|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
531430|NCT00809159|B5|Baseline|Total|Total of all reporting groups
531431|NCT00809159|B4|Baseline|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531432|NCT00809159|B3|Baseline|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531433|NCT00809159|B2|Baseline|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531434|NCT00809159|B1|Baseline|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531435|NCT00809159|P6|Participant Flow|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531436|NCT00809159|P5|Participant Flow|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531437|NCT00809159|P4|Participant Flow|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531438|NCT00809159|P3|Participant Flow|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531439|NCT00809159|P2|Participant Flow|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531440|NCT00809159|P1|Participant Flow|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531441|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531442|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531443|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531444|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
543855|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
531450|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531451|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531452|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531453|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531454|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531455|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/Kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531456|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531457|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531458|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531459|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531460|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531461|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531462|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531463|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531464|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531465|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531466|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531467|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531468|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531469|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531470|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531471|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531472|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531473|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531474|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531475|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531476|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531477|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531478|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531479|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531480|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531481|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531482|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531483|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531484|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531485|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531486|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531487|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531488|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531489|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531490|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531491|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531492|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531493|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531494|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531495|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531496|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
531497|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
531498|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
531499|NCT00809159|E4|Reported Event|Placebo|Placebo to AIN457A was administered intravenously as a single dose
531500|NCT00809159|E3|Reported Event|AIN457 2x0.1mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531501|NCT00809159|E2|Reported Event|AIN457 2x1.0mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531502|NCT00809159|E1|Reported Event|AIN457 2x10mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
531503|NCT00809185|B1|Baseline|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
531504|NCT00809185|P1|Participant Flow|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
531505|NCT00809185|O1|Outcome|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
531506|NCT00809185|E1|Reported Event|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
531507|NCT00809276|B1|Baseline|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
531508|NCT00809276|P1|Participant Flow|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
531509|NCT00809276|O1|Outcome|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
531510|NCT00809276|E1|Reported Event|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
531511|NCT00809328|B1|Baseline|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
531512|NCT00809328|P1|Participant Flow|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
531513|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
531514|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
531515|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
531516|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
531517|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
531518|NCT00809328|E1|Reported Event|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
531519|NCT00809445|B4|Baseline|Total|Total of all reporting groups
531520|NCT00809445|B3|Baseline|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
531521|NCT00809445|B2|Baseline|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
531522|NCT00809445|B1|Baseline|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
531523|NCT00809445|P3|Participant Flow|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
531524|NCT00809445|P2|Participant Flow|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
531525|NCT00809445|P1|Participant Flow|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
531526|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
543856|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
531527|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
531528|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
531529|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
531530|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
531531|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
531532|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
531533|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
531534|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
531535|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
531536|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
531537|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
531538|NCT00809445|E3|Reported Event|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
531539|NCT00809445|E2|Reported Event|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
531540|NCT00809445|E1|Reported Event|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
531541|NCT00809458|B3|Baseline|Total|Total of all reporting groups
531542|NCT00809458|B2|Baseline|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
531543|NCT00809458|B1|Baseline|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
531544|NCT00809458|P2|Participant Flow|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
531545|NCT00809458|P1|Participant Flow|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
531546|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
531547|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
531548|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
531549|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
531550|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
531551|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
531552|NCT00809458|E2|Reported Event|Arm 2|"Placebo (same vehicle as used for vitamin E)
Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy."
531553|NCT00809458|E1|Reported Event|Arm 1 (Vitamin E)|"Vitamin E
Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy."
531554|NCT00809471|B4|Baseline|Total|Total of all reporting groups
531555|NCT00809471|B3|Baseline|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
531556|NCT00809471|B2|Baseline|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
531557|NCT00809471|B1|Baseline|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
531558|NCT00809471|P3|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
531559|NCT00809471|P2|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
531560|NCT00809471|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
531561|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
531562|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
531563|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
531564|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
531565|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
531566|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
543857|NCT00832416|O4|Outcome|4: Placebo|
531567|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
531568|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
531569|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
531570|NCT00809471|E3|Reported Event|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
531571|NCT00809471|E2|Reported Event|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
531572|NCT00809471|E1|Reported Event|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
531573|NCT00809523|B3|Baseline|Total|Total of all reporting groups
531574|NCT00809523|B2|Baseline|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
531575|NCT00809523|B1|Baseline|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
531576|NCT00809523|P2|Participant Flow|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
531577|NCT00809523|P1|Participant Flow|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
531578|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
531579|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
531580|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
531581|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
531582|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
531583|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
531584|NCT00809523|E2|Reported Event|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
531585|NCT00809523|E1|Reported Event|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
531586|NCT00809614|B3|Baseline|Total|Total of all reporting groups
531587|NCT00809614|B2|Baseline|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531588|NCT00809614|B1|Baseline|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531589|NCT00809614|P2|Participant Flow|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531590|NCT00809614|P1|Participant Flow|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531591|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531592|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531593|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531594|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531595|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531596|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531597|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531598|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531599|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531600|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531601|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531602|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531603|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531604|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531605|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531606|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531607|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531608|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531609|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531610|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531611|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531612|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531613|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531614|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531615|NCT00809614|E2|Reported Event|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
531616|NCT00809614|E1|Reported Event|AIN457 2x10mg/kg|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
531617|NCT00809757|B4|Baseline|Total|Total of all reporting groups
531618|NCT00809757|B3|Baseline|Levalbuterol UDV|Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531619|NCT00809757|B2|Baseline|Levalbuterol MDI|Levalbuterol MDI TID
531620|NCT00809757|B1|Baseline|Placebo|Placebo Placebo MDI TID
531621|NCT00809757|P3|Participant Flow|Levalbuterol UDV|"0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID"
531622|NCT00809757|P2|Participant Flow|Levalbuterol MDI|"90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)"
531623|NCT00809757|P1|Participant Flow|Placebo|Placebo: Placebo (2 actuations)
531624|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531625|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531626|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531627|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531628|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531629|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531630|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531631|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531632|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531633|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531634|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531635|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531636|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531637|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531638|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531639|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531640|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531641|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531642|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531643|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531644|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
531645|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531646|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531647|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531648|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531649|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531650|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531651|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531652|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531653|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
531654|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531655|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531656|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531657|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531658|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531659|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531660|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531661|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531662|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531663|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531664|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531665|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531666|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531667|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531668|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531669|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531670|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531671|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531672|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531673|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531674|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531675|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531676|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531677|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531678|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531679|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531680|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531682|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531683|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531684|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
531685|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531686|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
531687|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531688|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531689|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
531690|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
531691|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531692|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531693|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
531694|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531695|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531696|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531697|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531698|NCT00809757|O1|Outcome|Placebo|"PBO MDI
Placebo: Placebo (2 actuations) MDI TID"
531699|NCT00809757|O3|Outcome|Levalbuterol UDV|"0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID"
531700|NCT00809757|O2|Outcome|Levalbuterol MDI|"90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)"
531701|NCT00809757|O1|Outcome|Placebo|Placebo: Placebo (2 actuations)
531702|NCT00809757|E3|Reported Event|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
531703|NCT00809757|E2|Reported Event|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
531704|NCT00809757|E1|Reported Event|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
531705|NCT00809809|B3|Baseline|Total|Total of all reporting groups
531706|NCT00809809|B2|Baseline|Placebo Treatment|Placebo medication - Swabs identical to medication group
531707|NCT00809809|B1|Baseline|Active Treatment|Active medication - Zinc Swabs
531708|NCT00809809|P2|Participant Flow|Placebo Treatment|Placebo medication - Swabs identical to medication group
531709|NCT00809809|P1|Participant Flow|Active Treatment|Active medication - Zinc Swabs
531710|NCT00809809|O2|Outcome|Placebo Treatment|Placebo medication - Swabs identical to medication group
531711|NCT00809809|O1|Outcome|Active Treatment|Active medication - Zinc Swabs
531712|NCT00809809|E2|Reported Event|Placebo Treatment|Placebo medication - Swabs identical to medication group
531713|NCT00809809|E1|Reported Event|Active Treatment|Active medication - Zinc Swabs
531714|NCT00809835|B5|Baseline|Total|Total of all reporting groups
531715|NCT00809835|B4|Baseline|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
531716|NCT00809835|B3|Baseline|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
531717|NCT00809835|B2|Baseline|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
531718|NCT00809835|B1|Baseline|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
531719|NCT00809835|P4|Participant Flow|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
531720|NCT00809835|P3|Participant Flow|Placebo and CBT|TAU plus computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
531721|NCT00809835|P2|Participant Flow|Galantamine Only|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
531722|NCT00809835|P1|Participant Flow|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
531723|NCT00809835|O4|Outcome|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
543858|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
531724|NCT00809835|O3|Outcome|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
531725|NCT00809835|O2|Outcome|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
531726|NCT00809835|O1|Outcome|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
531727|NCT00809835|O4|Outcome|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
531728|NCT00809835|O3|Outcome|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
531729|NCT00809835|O2|Outcome|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
531730|NCT00809835|O1|Outcome|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
531731|NCT00809835|O4|Outcome|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
531732|NCT00809835|O3|Outcome|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
531733|NCT00809835|O2|Outcome|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
531734|NCT00809835|O1|Outcome|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
531735|NCT00809835|E4|Reported Event|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
531736|NCT00809835|E3|Reported Event|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
531737|NCT00809835|E2|Reported Event|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
531738|NCT00809835|E1|Reported Event|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule
Other Names:
Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
531739|NCT00809848|B6|Baseline|Total|Total of all reporting groups
531740|NCT00809848|B5|Baseline|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
531741|NCT00809848|B4|Baseline|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
531742|NCT00809848|B3|Baseline|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
531743|NCT00809848|B2|Baseline|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
531744|NCT00809848|B1|Baseline|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
531745|NCT00809848|P5|Participant Flow|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
531746|NCT00809848|P4|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
531838|NCT00810043|E2|Reported Event|IBT-First|Use of the inflatable bone tamps prior to using the curette
531747|NCT00809848|P3|Participant Flow|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
531748|NCT00809848|P2|Participant Flow|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
531749|NCT00809848|P1|Participant Flow|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
531750|NCT00809848|O5|Outcome|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
531751|NCT00809848|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
531752|NCT00809848|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
531753|NCT00809848|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
531754|NCT00809848|O1|Outcome|AGN 210669 Non-preserved Ophthalmic Solution, 0.075%|AGN 210669 non-preserved ophthalmic solution, 0.075%. One drop in each eye each morning once-daily for 2 weeks.
531755|NCT00809848|O5|Outcome|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
531756|NCT00809848|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
531757|NCT00809848|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
531758|NCT00809848|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
531759|NCT00809848|O1|Outcome|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
531760|NCT00809848|E5|Reported Event|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
531761|NCT00809848|E4|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
531762|NCT00809848|E3|Reported Event|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
531763|NCT00809848|E2|Reported Event|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
531764|NCT00809848|E1|Reported Event|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
531765|NCT00809926|B3|Baseline|Total|Total of all reporting groups
531766|NCT00809926|B2|Baseline|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531767|NCT00809926|B1|Baseline|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531768|NCT00809926|P2|Participant Flow|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531769|NCT00809926|P1|Participant Flow|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531770|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531771|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531772|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531773|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531774|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531775|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531776|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531777|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531778|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531779|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531780|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531781|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531782|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531839|NCT00810043|E1|Reported Event|Curette-First|Use of the curette prior to use of the inflatable bone tamps
531840|NCT00810069|B3|Baseline|Total|Total of all reporting groups
531783|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531784|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531785|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531786|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531787|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531788|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
531789|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
531790|NCT00809926|E2|Reported Event|Valsartan|Valsartan (160mg) for 2weeks followed by forced titration toValsartan (320mg) for the remaining 6 weeks
531791|NCT00809926|E1|Reported Event|Valsartan/ Aliskiren|Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks
531792|NCT00809965|B4|Baseline|Total|Total of all reporting groups
531793|NCT00809965|B3|Baseline|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
531794|NCT00809965|B2|Baseline|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
531795|NCT00809965|B1|Baseline|Placebo|One placebo tablet twice daily
531796|NCT00809965|P3|Participant Flow|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
531797|NCT00809965|P2|Participant Flow|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
531798|NCT00809965|P1|Participant Flow|Placebo|One placebo tablet twice daily
531799|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
531800|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
531801|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
531802|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
531803|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
531804|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
531805|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
531806|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
531807|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
531808|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
531809|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
531810|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
531811|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
531812|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
531813|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
531814|NCT00809965|E3|Reported Event|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
531815|NCT00809965|E2|Reported Event|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
531816|NCT00809965|E1|Reported Event|Placebo|One placebo tablet twice daily
531817|NCT00810043|B3|Baseline|Total|Total of all reporting groups
531818|NCT00810043|B2|Baseline|IBT-First|Use of the inflatable bone tamps prior to using the curette
531819|NCT00810043|B1|Baseline|Curette-First|Use of the curette prior to use of the inflatable bone tamps
531820|NCT00810043|P3|Participant Flow|Non-treated Patients|Patients who met the enrollment criteria at screening who had terminated prior to surgery or those who no longer met the inclusion criteria due to new fractures prior to surgery. These patients were never randomized to treatment because randomization was performed in the operating room.
531821|NCT00810043|P2|Participant Flow|IBT-First|Use of the inflatable bone tamps prior to using the curette
531822|NCT00810043|P1|Participant Flow|Curette-First|Use of the curette prior to use of the inflatable bone tamps
531823|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
531824|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
531825|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
531826|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
531827|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
531828|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
531829|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
531830|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
531831|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
531832|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
531833|NCT00810043|O1|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
531834|NCT00810043|O2|Outcome|IBT-First|Use of the inflatable bone tamps prior to using the curette
531835|NCT00810043|O1|Outcome|Curette-First|Use of the curette prior to use of the inflatable bone tamps
531836|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
531837|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
531841|NCT00810069|B2|Baseline|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531842|NCT00810069|B1|Baseline|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531843|NCT00810069|P3|Participant Flow|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531844|NCT00810069|P2|Participant Flow|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531845|NCT00810069|P1|Participant Flow|Escitalopram (Acute Treatment)|Escitalopram 10 milligrams (mg) per day for 4 weeks
531846|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531847|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531848|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531849|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531850|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531851|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531852|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531853|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531854|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531855|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531856|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531857|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531858|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531859|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531860|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531861|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531862|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531863|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531864|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531865|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531866|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531867|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531868|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531869|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531870|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531871|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531872|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531873|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531874|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531875|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531876|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531877|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531878|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531879|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531880|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
531881|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
531882|NCT00810069|E5|Reported Event|Delayed Intervention Non-Responders|Duloxetine 60 or 120 mg per day for 8 weeks.
531883|NCT00810069|E4|Reported Event|Delayed Intervention Responders|Escitalopram 10 to 20 mg per day for 8 weeks.
531884|NCT00810069|E3|Reported Event|Early Intervention (Double Blind)|Duloxetine flexible dose (60 or 120 milligram [mg] daily) for 12 weeks.
531885|NCT00810069|E2|Reported Event|Delayed Intervention (Double Blind)|Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule[s]). Then, non-responders switched to duloxetine 60 or 120 mg per day for 8 weeks, and responders continued on escitalopram 10 to 20 mg per day for 8 weeks.
531886|NCT00810069|E1|Reported Event|Escitalopram (Acute Treatment)|Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule)
531887|NCT00810082|B3|Baseline|Total|Total of all reporting groups
531888|NCT00810082|B2|Baseline|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
531889|NCT00810082|B1|Baseline|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
531890|NCT00810082|P2|Participant Flow|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
531891|NCT00810082|P1|Participant Flow|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
531892|NCT00810082|O2|Outcome|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
531893|NCT00810082|O1|Outcome|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
531894|NCT00810082|E2|Reported Event|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
531895|NCT00810082|E1|Reported Event|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
531896|NCT00810095|B1|Baseline|Treatment Group|All participants treated with the Test System
531897|NCT00810095|P1|Participant Flow|MindFrame System Treatment Group|All participants with acute ischemic stroke who were treated with the 1st generation MindFrame System of neurothrombotic stent retrievers. The first generation MindFrame System was a self-expanding nitinol stent retriever mounted on a hypotube delivery wire and delivered to the occlusion site via a 0.027 inch microcatheter. Eligible patients were aged 18-80 years, had a baseline NIHSS score of 6-30, had a thrombotic occlusion of the ICA, MCA (M1 or M2) or basilar arteries, and could be treated within 6 hours of stroke onset.
531898|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
531899|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
531900|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
531901|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
531902|NCT00810095|E1|Reported Event|Treatment Group|All participants treated with the Test System
531903|NCT00810108|B3|Baseline|Total|Total of all reporting groups
531904|NCT00810108|B2|Baseline|Crushed Then Whole Tablets|These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
531905|NCT00810108|B1|Baseline|Whole Then Crushed Tablets|These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
531906|NCT00810108|P2|Participant Flow|Crushed Then Whole Tablets|These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
531907|NCT00810108|P1|Participant Flow|Whole Then Crushed Tablets|These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
531908|NCT00810108|O2|Outcome|All Subjects Taking Crushed Tablets|Lopinavir AUC from all subjects taking the crushed tablet
531909|NCT00810108|O1|Outcome|All Subjects Taking Whole Tablets|Lopinavir AUC from all subjects taking the whole tablet
531910|NCT00810108|E1|Reported Event|All Subjects|Data from all subjects combined
531911|NCT00810199|B3|Baseline|Total|Total of all reporting groups
531912|NCT00810199|B2|Baseline|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531913|NCT00810199|B1|Baseline|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531914|NCT00810199|P2|Participant Flow|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531915|NCT00810199|P1|Participant Flow|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531916|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531917|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531918|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531995|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
531919|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531920|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531921|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531922|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531923|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531924|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added
531925|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
531926|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
531927|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
531928|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531929|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531930|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531931|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531932|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531933|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531934|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531935|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531936|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531937|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531996|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
531997|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
531998|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
531938|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531939|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531940|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531941|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531942|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531943|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531944|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531945|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531999|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
532000|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
532001|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
531946|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531947|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531948|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531949|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531950|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531951|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531952|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531953|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
532002|NCT00810277|E1|Reported Event|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
532003|NCT00810303|B1|Baseline|Study Group|whole study group: 12 healthy subjects
532004|NCT00810303|P1|Participant Flow|Study Group|whole study group: 12 healthy subjects
532005|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
531954|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531955|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531956|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531957|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531958|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531959|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531960|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531961|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
532006|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
532007|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
532008|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
532009|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
532010|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
532011|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
531962|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531963|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531964|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531965|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531966|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
531967|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
531968|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
531969|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
531970|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531971|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531972|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531973|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531974|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531975|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531976|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531977|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531978|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531979|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531980|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
532012|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
532013|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
532014|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
532015|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
532016|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
532017|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
531981|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531982|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531983|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531984|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531985|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531986|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
531987|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
531988|NCT00810199|E2|Reported Event|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
531989|NCT00810199|E1|Reported Event|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
531990|NCT00810277|B1|Baseline|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
531991|NCT00810277|P1|Participant Flow|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
531992|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
531993|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
531994|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
532024|NCT00810303|E4|Reported Event|Ezetimibe Multiple Dose and Efavirenz Single Dose|
532025|NCT00810303|E3|Reported Event|Ezetimibe Alone Multiple Dose|
532026|NCT00810303|E2|Reported Event|Efavirenz Alone Single Dose|
532027|NCT00810303|E1|Reported Event|Study Group|whole study group: 12 healthy subjects
532028|NCT00810342|B3|Baseline|Total|Total of all reporting groups
532029|NCT00810342|B2|Baseline|2 - Standard|"Website resources on physical activity
physical activity: standard print and website information on how to become more active"
532030|NCT00810342|B1|Baseline|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.
physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
532031|NCT00810342|P2|Participant Flow|2 - Standard|"Website resources on physical activity
physical activity: standard print and website information on how to become more active"
532032|NCT00810342|P1|Participant Flow|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.
physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
532033|NCT00810342|O2|Outcome|2 - Physical Activity Standard|"Standard Website resources / information on physical activity
physical activity standard: standard print and website information on how to become more active"
532034|NCT00810342|O1|Outcome|1- Physical Activity Tailored|"Tailored telephone counseling about how to become more physically active and goal setting. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.
physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
532035|NCT00810342|O2|Outcome|2 - Standard|"Website resources on physical activity
physical activity: standard print and website information on how to become more active"
532036|NCT00810342|O1|Outcome|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.
physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
532037|NCT00810342|E2|Reported Event|2 - Standard|"Website resources on physical activity
physical activity: standard print and website information on how to become more active"
532038|NCT00810342|E1|Reported Event|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.
physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
532039|NCT00810355|B4|Baseline|Total|Total of all reporting groups
532040|NCT00810355|B3|Baseline|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation
Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
Cognitive Remediation: Computerized training to enhance cognitive functioning."
532041|NCT00810355|B2|Baseline|Cognitive Behavior Therapy|"Cognitive Behavior Therapy
Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
532042|NCT00810355|B1|Baseline|Support Group|"Support group
Support Group: General support and problem solving for work activity"
532043|NCT00810355|P3|Participant Flow|Cognitive Behavior Therapy and Cognitive Remediation|"Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
Cognitive Remediation: Computerized training to enhance cognitive functioning."
532044|NCT00810355|P2|Participant Flow|Cognitive Behavior Therapy|Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
532045|NCT00810355|P1|Participant Flow|Support Group|Support Group: General support and problem solving for work activity
532046|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation
Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
Cognitive Remediation: Computerized training to enhance cognitive functioning."
532047|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy
Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
532048|NCT00810355|O1|Outcome|Support Group|"Support group
Support Group: General support and problem solving for work activity"
532049|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation
Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
Cognitive Remediation: Computerized training to enhance cognitive functioning."
532050|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy
Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
532051|NCT00810355|O1|Outcome|Support Group|"Support group
Support Group: General support and problem solving for work activity"
532052|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation
Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
Cognitive Remediation: Computerized training to enhance cognitive functioning."
532053|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy
Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
532054|NCT00810355|O1|Outcome|Support Group|"Support group
Support Group: General support and problem solving for work activity"
532723|NCT00812955|O2|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg
532055|NCT00810355|E3|Reported Event|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation
Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
Cognitive Remediation: Computerized training to enhance cognitive functioning."
532056|NCT00810355|E2|Reported Event|Cognitive Behavior Therapy|"Cognitive Behavior Therapy
Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
532057|NCT00810355|E1|Reported Event|Support Group|"Support group
Support Group: General support and problem solving for work activity"
532058|NCT00810368|B3|Baseline|Total|Total of all reporting groups
532059|NCT00810368|B2|Baseline|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
532060|NCT00810368|B1|Baseline|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
532061|NCT00810368|P2|Participant Flow|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
532062|NCT00810368|P1|Participant Flow|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
532063|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
532064|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
532065|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
532066|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
532067|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
532068|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
532069|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
532070|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
532071|NCT00810368|O2|Outcome|Placebo Control Group|"Placebo control group
Placebo: Microcrystalline cellulose placebo tablets x2 daily"
532072|NCT00810368|O1|Outcome|Carnosine Treatment Group|"Carnosine treatment group
Carnosine: 500mg Carnosine x2 daily"
532073|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
532074|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
532075|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
532076|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
532077|NCT00810368|E2|Reported Event|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
532078|NCT00810368|E1|Reported Event|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
532079|NCT00810394|B1|Baseline|Sorafenib|"Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
532169|NCT00811798|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
543859|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
532080|NCT00810394|P1|Participant Flow|Sorafenib|"Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
532081|NCT00810394|O1|Outcome|Sorafenib|"Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
532082|NCT00810394|O1|Outcome|Sorafenib|"Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
532083|NCT00810394|O1|Outcome|Sorafenib|"Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
532084|NCT00810394|E1|Reported Event|Sorafenib|"Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
532085|NCT00811655|B1|Baseline|Pre-OP SRS|"SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.
therapeutic conventional surgery : Surgery of a single brain metastasis.
stereotactic radiosurgery : Pre-operative single fraction SRS"
532086|NCT00811655|P1|Participant Flow|Pre-Operative SRS|"Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
therapeutic conventional surgery : Surgery of a single brain metastasis.
stereotactic radiosurgery : Pre-operative single fraction SRS"
532087|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
532088|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
532089|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
532090|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
532091|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
532092|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
532093|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
532094|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
532095|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
532096|NCT00811655|E1|Reported Event|Pre-Operative SRS|"Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
therapeutic conventional surgery : Surgery of a single brain metastasis.
stereotactic radiosurgery : Pre-operative single fraction SRS"
532097|NCT00811720|B3|Baseline|Total|Total of all reporting groups
532098|NCT00811720|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532099|NCT00811720|B1|Baseline|Placebo|as-needed use, tablets, orally, 6 months
532100|NCT00811720|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532101|NCT00811720|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 6 months
532102|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532103|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532104|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532105|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532106|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532107|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532108|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532109|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532110|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532111|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532112|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532113|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532114|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532115|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532116|NCT00811720|E2|Reported Event|Nalmefene 18.06 mg|
532117|NCT00811720|E1|Reported Event|Placebo|
532118|NCT00811733|B3|Baseline|Total|Total of all reporting groups
532119|NCT00811733|B2|Baseline|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532120|NCT00811733|B1|Baseline|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532121|NCT00811733|P2|Participant Flow|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532122|NCT00811733|P1|Participant Flow|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532123|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532124|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532125|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532126|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532127|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532170|NCT00811798|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
532171|NCT00811850|B1|Baseline|All Patients|All patients in the study
532172|NCT00811850|P1|Participant Flow|All Patients|This was a cross-over study with 3 treatment periods. In Treatment Period 1, patients received either Combigan® or Cosopt®. In Treatment Period 2, patients were washed out of their previous treatment. In Treatment Period 3, patients received either Combigan® or Cosopt® (treatment not received in Treatment Period 1).
543860|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
532128|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532129|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532130|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532131|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532132|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532133|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532134|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532135|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532136|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532137|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532138|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532139|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532140|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532141|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532142|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532143|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532144|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532145|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532146|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532147|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532148|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532149|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532150|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532151|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532152|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532153|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532154|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532155|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532156|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532157|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532158|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532159|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532160|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532161|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532162|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532163|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532164|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532165|NCT00811733|E2|Reported Event|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
532166|NCT00811733|E1|Reported Event|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
532167|NCT00811798|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
532168|NCT00811798|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
532552|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532173|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532174|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532175|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532176|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532177|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532178|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532179|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532180|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532181|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532182|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532183|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532184|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532185|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532186|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532187|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532188|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532189|NCT00811850|E2|Reported Event|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532190|NCT00811850|E1|Reported Event|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
532191|NCT00811928|B3|Baseline|Total|Total of all reporting groups
532192|NCT00811928|B2|Baseline|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
532193|NCT00811928|B1|Baseline|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
532194|NCT00811928|P2|Participant Flow|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
532195|NCT00811928|P1|Participant Flow|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
532196|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
532197|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
532198|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
532199|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
532200|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
532201|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
532202|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
532203|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
532204|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
532205|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
532206|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
532207|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
532208|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
532209|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
532210|NCT00811928|E2|Reported Event|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
532211|NCT00811928|E1|Reported Event|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
532212|NCT00811941|B3|Baseline|Total|Total of all reporting groups
532213|NCT00811941|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532214|NCT00811941|B1|Baseline|Placebo|as-needed use, tablets, orally, 52 weeks
532215|NCT00811941|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532216|NCT00811941|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 52 weeks
532217|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532218|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532219|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532220|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532221|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532222|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532223|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532224|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532225|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532226|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532227|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532228|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532229|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532230|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532231|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532232|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532233|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532234|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532235|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532236|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532237|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532238|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532239|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532240|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532241|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532242|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532243|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532244|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532245|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532246|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532247|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532248|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
532249|NCT00811941|E2|Reported Event|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
532250|NCT00811941|E1|Reported Event|Placebo|as-needed use, tablets, orally, 52 weeks
532251|NCT00811954|B4|Baseline|Total|Total of all reporting groups
532252|NCT00811954|B3|Baseline|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532253|NCT00811954|B2|Baseline|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532254|NCT00811954|B1|Baseline|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532255|NCT00811954|P3|Participant Flow|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532256|NCT00811954|P2|Participant Flow|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532257|NCT00811954|P1|Participant Flow|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532258|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532259|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
543861|NCT00832416|O4|Outcome|4: Placebo|
532260|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532261|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532262|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532263|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532264|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532265|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532266|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532267|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532268|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532269|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532270|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532271|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532272|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532273|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532274|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532275|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532276|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532277|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532278|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532279|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532280|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532281|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532414|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532282|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532283|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532284|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532285|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532286|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532287|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532288|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532289|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532290|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532291|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532292|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532293|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532294|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532295|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532296|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532297|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532298|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532299|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532300|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532301|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532302|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532303|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532304|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532305|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532306|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532307|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532308|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532309|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532310|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532311|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532312|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532313|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532314|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532315|NCT00811954|E3|Reported Event|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
532316|NCT00811954|E2|Reported Event|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
532317|NCT00811954|E1|Reported Event|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
532318|NCT00812006|B4|Baseline|Total|Total of all reporting groups
532319|NCT00812006|B3|Baseline|Placebo / Rizatriptan / Rizatriptan|First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
532320|NCT00812006|B2|Baseline|Rizatriptan / Placebo / Rizatriptan|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
532321|NCT00812006|B1|Baseline|Rizatriptan / Rizatriptan / Placebo|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo
532322|NCT00812006|P3|Participant Flow|Placebo / Rizatriptan / Rizatriptan|First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
532323|NCT00812006|P2|Participant Flow|Rizatriptan / Placebo / Rizatriptan|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
532324|NCT00812006|P1|Participant Flow|Rizatriptan / Rizatriptan / Placebo|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo
532325|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
532326|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
532327|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
532328|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
532596|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532329|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
532330|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
532331|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
532332|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
532333|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
532334|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
532335|NCT00812006|E2|Reported Event|Placebo|"Placebo. Patients who treated an attack with placebo were included. Adverse events occurring within 14 days of administration of placebo, but not within 14 days of any administration of rizatriptan (including sponsor-provided rescue), were attributed to placebo group.
It is possible for one patient to be counted twice (once in each treatment group).
The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo."
532336|NCT00812006|E1|Reported Event|Rizatriptan|"Rizatriptan 10 mg. Patients who treated at least one attack with rizatriptan 10 mg (including sponsor-provided rescue) were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group. Adverse events occurring within 14 days of any administration of rizatriptan (including sponsor-provided rescue) were attributed to rizatriptan group, even if placebo was administered more recently.
It is possible for one patient to be counted twice (once in each treatment group).
The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo."
532337|NCT00812097|B5|Baseline|Total|Total of all reporting groups
532338|NCT00812097|B4|Baseline|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532339|NCT00812097|B3|Baseline|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532340|NCT00812097|B2|Baseline|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532341|NCT00812097|B1|Baseline|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532342|NCT00812097|P4|Participant Flow|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532343|NCT00812097|P3|Participant Flow|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532415|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532416|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532417|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532344|NCT00812097|P2|Participant Flow|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532345|NCT00812097|P1|Participant Flow|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532346|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532347|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532348|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532349|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532350|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532351|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532352|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532353|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532354|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532355|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532720|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
532356|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532357|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532358|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532359|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532360|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532361|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532362|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532363|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532364|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532365|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532366|NCT00812097|E4|Reported Event|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532367|NCT00812097|E3|Reported Event|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532721|NCT00812955|O2|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg
532368|NCT00812097|E2|Reported Event|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532369|NCT00812097|E1|Reported Event|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
532370|NCT00812110|B1|Baseline|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
532371|NCT00812110|P1|Participant Flow|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
532372|NCT00812110|O1|Outcome|Caregivers|Caregivers of children at risk for complications of influenza
532373|NCT00812110|O1|Outcome|Caregivers|Caregivers of children at risk for complications of influenza
532374|NCT00812110|E1|Reported Event|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
532375|NCT00812253|B3|Baseline|Total|Total of all reporting groups
532376|NCT00812253|B2|Baseline|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
532377|NCT00812253|B1|Baseline|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
532378|NCT00812253|P2|Participant Flow|Subcutaneous Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
532379|NCT00812253|P1|Participant Flow|Intravenous Insulin (IV)|Intravenous insulin: In patients assigned to intravenous (IV) insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
532380|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
532381|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
532382|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
532383|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
532418|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532419|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532722|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
532384|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
532385|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
532386|NCT00812253|E2|Reported Event|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
532387|NCT00812253|E1|Reported Event|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
532388|NCT00812331|B6|Baseline|Total|Total of all reporting groups
532389|NCT00812331|B5|Baseline|Genotype 6|Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
532390|NCT00812331|B4|Baseline|Genotype 5|Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
532391|NCT00812331|B3|Baseline|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
532392|NCT00812331|B2|Baseline|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
532393|NCT00812331|B1|Baseline|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
532394|NCT00812331|P5|Participant Flow|Genotype 6|Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
532395|NCT00812331|P4|Participant Flow|Genotype 5|Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
532396|NCT00812331|P3|Participant Flow|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
532397|NCT00812331|P2|Participant Flow|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
532398|NCT00812331|P1|Participant Flow|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
532399|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532400|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532401|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532402|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532403|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532404|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532405|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532406|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532407|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532408|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532409|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532410|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532411|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532412|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532413|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532420|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532421|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532422|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532423|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532424|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532425|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532426|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532427|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532428|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532429|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532430|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532431|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532432|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532433|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532434|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532435|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532436|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532437|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532438|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532439|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532440|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532441|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532442|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532443|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532444|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532445|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532446|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532447|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532448|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532449|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532450|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532451|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532452|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532453|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532454|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532455|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532456|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532457|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
543862|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
532458|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532459|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532460|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532461|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532462|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532463|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532464|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532465|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532466|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532467|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532468|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
532469|NCT00812331|E1|Reported Event|Total|Participants with chronic genotype 2,3,4,5 or 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
532470|NCT00812461|B3|Baseline|Total|Total of all reporting groups
532471|NCT00812461|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532472|NCT00812461|B1|Baseline|Placebo|as-needed use, tablets, orally, 6 months
532473|NCT00812461|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532474|NCT00812461|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 6 months
532475|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532476|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532477|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532478|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532479|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532480|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532481|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532482|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532483|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532484|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532485|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532486|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532487|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532488|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
532489|NCT00812461|E2|Reported Event|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
532490|NCT00812461|E1|Reported Event|Placebo|as-needed use, tablets, orally, 6 months
532491|NCT00812487|B3|Baseline|Total|Total of all reporting groups
532492|NCT00812487|B2|Baseline|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532493|NCT00812487|B1|Baseline|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532494|NCT00812487|P2|Participant Flow|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532495|NCT00812487|P1|Participant Flow|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532496|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532497|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532498|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532499|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532500|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532501|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532502|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532503|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532504|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532505|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532506|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532507|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532508|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532509|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532510|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532511|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532512|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532513|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532514|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532515|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532516|NCT00812487|E2|Reported Event|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
532517|NCT00812487|E1|Reported Event|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
532518|NCT00812565|B9|Baseline|Total|Total of all reporting groups
532519|NCT00812565|B8|Baseline|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532520|NCT00812565|B7|Baseline|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532521|NCT00812565|B6|Baseline|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532522|NCT00812565|B5|Baseline|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532523|NCT00812565|B4|Baseline|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532524|NCT00812565|B3|Baseline|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532525|NCT00812565|B2|Baseline|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532526|NCT00812565|B1|Baseline|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532527|NCT00812565|P8|Participant Flow|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532528|NCT00812565|P7|Participant Flow|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532529|NCT00812565|P6|Participant Flow|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532530|NCT00812565|P5|Participant Flow|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532531|NCT00812565|P4|Participant Flow|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532532|NCT00812565|P3|Participant Flow|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532533|NCT00812565|P2|Participant Flow|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532534|NCT00812565|P1|Participant Flow|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532535|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532536|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532537|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532538|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532539|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532540|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532541|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532542|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532543|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532544|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532545|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532546|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532547|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532548|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532549|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532550|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532551|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532553|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532554|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532555|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532556|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532557|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532558|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532559|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532560|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532561|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532562|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532563|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532564|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532565|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532566|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532567|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532568|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532569|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532570|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532571|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532572|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532573|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532574|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532575|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532576|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532577|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532578|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532579|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532580|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532581|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532582|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532583|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532584|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532585|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532586|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532587|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532588|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532589|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532590|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532591|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532592|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532593|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532594|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532595|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532597|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532598|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532599|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532600|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532601|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532602|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532603|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532604|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532605|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532606|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532607|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532608|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532609|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532610|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532611|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532612|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532613|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532614|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532615|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532616|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532617|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532618|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532619|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532620|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532621|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532622|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532623|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532624|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532625|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532626|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532627|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532628|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532629|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532630|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532631|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532632|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532633|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532634|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532635|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532636|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532637|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532638|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532639|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532640|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532641|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532642|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532643|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532644|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532645|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532646|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532647|NCT00812565|E8|Reported Event|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532648|NCT00812565|E7|Reported Event|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
532649|NCT00812565|E6|Reported Event|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532650|NCT00812565|E5|Reported Event|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
532651|NCT00812565|E4|Reported Event|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532652|NCT00812565|E3|Reported Event|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
532653|NCT00812565|E2|Reported Event|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532654|NCT00812565|E1|Reported Event|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
532655|NCT00812604|B3|Baseline|Total|Total of all reporting groups
532656|NCT00812604|B2|Baseline|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
532657|NCT00812604|B1|Baseline|Ping On Ointment Group|Ping On Ointment was used
532658|NCT00812604|P2|Participant Flow|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
532659|NCT00812604|P1|Participant Flow|Ping On Ointment Group|Ping On Ointment was used
532660|NCT00812604|O2|Outcome|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
532661|NCT00812604|O1|Outcome|Ping On Ointment Group|Ping On Ointment was used
532662|NCT00812604|O2|Outcome|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
532663|NCT00812604|O1|Outcome|Ping On Ointment Group|Ping On Ointment was used
532664|NCT00812604|E2|Reported Event|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
532665|NCT00812604|E1|Reported Event|Ping On Ointment Group|Ping On Ointment was used
532666|NCT00812812|B3|Baseline|Total|Total of all reporting groups
532667|NCT00812812|B2|Baseline|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
532668|NCT00812812|B1|Baseline|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
532669|NCT00812812|P2|Participant Flow|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase (total of 8 weeks). During the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase, (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
532670|NCT00812812|P1|Participant Flow|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
532671|NCT00812812|O1|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
532672|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
532673|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
532674|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
532675|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
532676|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
532677|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
532678|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
532679|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
532680|NCT00812812|E2|Reported Event|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
532681|NCT00812812|E1|Reported Event|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
532682|NCT00812877|B3|Baseline|Total|Total of all reporting groups
532683|NCT00812877|B2|Baseline|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
532684|NCT00812877|B1|Baseline|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
532685|NCT00812877|P2|Participant Flow|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
532686|NCT00812877|P1|Participant Flow|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
532687|NCT00812877|O2|Outcome|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
532688|NCT00812877|O1|Outcome|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
532689|NCT00812877|O2|Outcome|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
532690|NCT00812877|O1|Outcome|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
532691|NCT00812877|E2|Reported Event|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
532692|NCT00812877|E1|Reported Event|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
532693|NCT00812916|B1|Baseline|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
532694|NCT00812916|P1|Participant Flow|Number of Patients|Radiofrequency (RF) Ablation using specialized complex fractionated atrial electrogram (CFAE) software
532695|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized CFAE software
532696|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
532697|NCT00812916|O1|Outcome|RF Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
532698|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized CFAE software
532699|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
532700|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
532701|NCT00812916|E1|Reported Event|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
532702|NCT00812955|B5|Baseline|Total|Total of all reporting groups
532703|NCT00812955|B4|Baseline|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
532704|NCT00812955|B3|Baseline|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
532705|NCT00812955|B2|Baseline|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
532706|NCT00812955|B1|Baseline|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
532707|NCT00812955|P4|Participant Flow|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
532708|NCT00812955|P3|Participant Flow|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
532709|NCT00812955|P2|Participant Flow|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
532710|NCT00812955|P1|Participant Flow|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
532711|NCT00812955|O4|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
532712|NCT00812955|O3|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
532713|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
532714|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
532715|NCT00812955|O4|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
532716|NCT00812955|O3|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
532717|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
532718|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
532719|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg
532724|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
532725|NCT00812955|E4|Reported Event|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
532726|NCT00812955|E3|Reported Event|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
532727|NCT00812955|E2|Reported Event|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
532728|NCT00812955|E1|Reported Event|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
532729|NCT00812968|B1|Baseline|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532730|NCT00812968|P1|Participant Flow|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle. Treatment continued until disease progression or relapse following an erythroid improvement was documented, any of the criteria for treatment discontinuation was violated, or lenalidomide became commercially available for the treatment of MDS associated with a del (5q) cytogenetic abnormality, for up to 156 weeks (3 years).
532731|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532732|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532733|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532734|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532735|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532736|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532737|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532738|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532739|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532740|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532741|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
532742|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
532743|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
532744|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
532745|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
532746|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
532747|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
532748|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
532749|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532750|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
532751|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
532752|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
532753|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
532754|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
532755|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
532756|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
532757|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
532758|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532759|NCT00812968|E1|Reported Event|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
532760|NCT00812981|B3|Baseline|Total|Total of all reporting groups
532761|NCT00812981|B2|Baseline|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532762|NCT00812981|B1|Baseline|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532763|NCT00812981|P2|Participant Flow|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532764|NCT00812981|P1|Participant Flow|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532765|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532766|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532767|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532768|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532769|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532770|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532771|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532772|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532773|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532774|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532775|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532776|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532777|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532778|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532779|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532780|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532781|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532782|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532783|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532784|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532785|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532786|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532787|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532788|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
533501|NCT00806416|E1|Reported Event|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
532789|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532790|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532791|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532792|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532793|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532794|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532795|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532796|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532797|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532798|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532799|NCT00812981|E2|Reported Event|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532800|NCT00812981|E1|Reported Event|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
532801|NCT00813098|B4|Baseline|Total|Total of all reporting groups
532802|NCT00813098|B3|Baseline|Placebo|Matching placebo dosing with daily oral intake
532803|NCT00813098|B2|Baseline|Low Dose|A low dose of LX1031; daily oral intake for 28 days
532804|NCT00813098|B1|Baseline|High Dose|A high dose of LX1031; daily oral intake for 28 days
532805|NCT00813098|P3|Participant Flow|Placebo|Matching placebo dosing with daily oral intake
532806|NCT00813098|P2|Participant Flow|Low Dose|A low dose of LX1031; daily oral intake for 28 days
532807|NCT00813098|P1|Participant Flow|High Dose|A high dose of LX1031; daily oral intake for 28 days
532808|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
532809|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
532810|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
532811|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
532812|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
532813|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
532814|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
532815|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
532816|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
532817|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
532818|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
532819|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
532820|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
532821|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
532822|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
532823|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
532824|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
532825|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
532826|NCT00813098|E3|Reported Event|Placebo|Matching placebo dosing with daily oral intake
532827|NCT00813098|E2|Reported Event|Low Dose|A low dose of LX1031; daily oral intake for 28 days
532828|NCT00813098|E1|Reported Event|High Dose|A high dose of LX1031; daily oral intake for 28 days
532829|NCT00813111|B3|Baseline|Total|Total of all reporting groups
532830|NCT00813111|B2|Baseline|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
532831|NCT00813111|B1|Baseline|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
532832|NCT00813111|P2|Participant Flow|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
533597|NCT00806624|B3|Baseline|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
532833|NCT00813111|P1|Participant Flow|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
532834|NCT00813111|O2|Outcome|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
532835|NCT00813111|O1|Outcome|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
532836|NCT00813111|E2|Reported Event|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
532837|NCT00813111|E1|Reported Event|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
532838|NCT00813150|B3|Baseline|Total|Total of all reporting groups
532839|NCT00813150|B2|Baseline|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
532840|NCT00813150|B1|Baseline|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
532841|NCT00813150|P2|Participant Flow|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
532842|NCT00813150|P1|Participant Flow|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
532843|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
532844|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
532845|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
532846|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
532847|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
532848|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
532849|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
532850|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
533063|NCT00813748|P2|Participant Flow|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
533598|NCT00806624|B2|Baseline|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
532851|NCT00813150|E2|Reported Event|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
532852|NCT00813150|E1|Reported Event|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
532853|NCT00813319|B3|Baseline|Total|Total of all reporting groups
532854|NCT00813319|B2|Baseline|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
532855|NCT00813319|B1|Baseline|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.
Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
532856|NCT00813319|P2|Participant Flow|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
532857|NCT00813319|P1|Participant Flow|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.
Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
532858|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
532859|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.
Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
532860|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
532861|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.
Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
532862|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
532863|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.
Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
532864|NCT00813319|E2|Reported Event|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
532865|NCT00813319|E1|Reported Event|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.
Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
532866|NCT00813488|B1|Baseline|Total Number of Patients|
532886|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
533599|NCT00806624|B1|Baseline|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
532867|NCT00813488|P2|Participant Flow|Immediate-Release Oxycodone First FBT Second|Subjects in this treatment group were assigned 15 mg oxycodone during the first titration period and then 200 mcg FBT during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
532868|NCT00813488|P1|Participant Flow|FBT First Immediate Release Oxycodone Second|Subjects in this treatment group were assigned 200 mcg FBT during the first titration period and then 15 mg oxycodone during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
532869|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
532870|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532871|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
532872|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532873|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
532874|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532875|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
532876|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532877|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
532878|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532879|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
532880|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532881|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
532882|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532883|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
532884|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532885|NCT00813488|O1|Outcome|Total|"Includes all patients who participated in the double-blind treatment period and completed treatment.
Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
543863|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
532887|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532888|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532889|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532890|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532891|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532892|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532893|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532894|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532895|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532896|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532897|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532909|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532898|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532899|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532900|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532901|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532902|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532903|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532904|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532905|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532906|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532907|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532908|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
533064|NCT00813748|P1|Participant Flow|Omalizumab Cases|Participants who received omalizumab (Xolair) and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533841|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
532910|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532911|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532912|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532913|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532914|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532915|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532916|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532917|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532918|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532919|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532920|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
533065|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
543864|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
532921|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532922|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532923|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532924|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532925|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532926|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532927|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532928|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532929|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532930|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532931|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532943|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532932|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532933|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532934|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532935|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532936|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532937|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532938|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532939|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532940|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532941|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532942|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
533066|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533600|NCT00806624|P3|Participant Flow|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
532944|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532945|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532946|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532947|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532948|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532949|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532950|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532951|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532952|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532953|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532954|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
533067|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
543865|NCT00832416|O4|Outcome|4: Placebo|
532955|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532956|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532957|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532958|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
532959|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.
During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
532960|NCT00813488|E3|Reported Event|Standard of Care|21 subjects received standard of care analgesics apart from oxycodone or FBT during the Open-Label Extension Period. Subjects who took oxycodone during SOC are listed under Oxycodone.
532961|NCT00813488|E2|Reported Event|Oxycodone|This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period (they were only exposed to one drug). 213 subjects began the first titration period and of those 27 discontinued before exposure to oxycodone. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 186 subjects had exposure to oxycodone
532962|NCT00813488|E1|Reported Event|Fentanyl Buccal Tablet|This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period. 213 subjects began the first titration period and of those 17 discontinued before exposure to FBT. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 196 subjects had exposure to FBT
532963|NCT00813592|B1|Baseline|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
532964|NCT00813592|P1|Participant Flow|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
532965|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
533502|NCT00806442|B1|Baseline|All Study Particpants|Includes patients scheduled to receive Borage and Echium seed oil first and participants scheduled to receive placebo first.
532966|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
532967|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
532968|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
532969|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
532970|NCT00813592|O1|Outcome|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
532971|NCT00813592|E1|Reported Event|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
532972|NCT00813709|B4|Baseline|Total|Total of all reporting groups
532973|NCT00813709|B3|Baseline|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (18 participants from DB converted to CDMS and switched to OL period over course of this study)
532974|NCT00813709|B2|Baseline|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (26 participants from DB converted to CDMS and switched to OL period over course of this study)
532989|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533842|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
532975|NCT00813709|B1|Baseline|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (9 participants from DB converted to CDMS and switched to OL period over course of this study)
532976|NCT00813709|P6|Participant Flow|RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
532977|NCT00813709|P5|Participant Flow|RNF 44 Mcg Once Weekly /OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
532978|NCT00813709|P4|Participant Flow|Placebo/RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
532979|NCT00813709|P3|Participant Flow|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
532980|NCT00813709|P2|Participant Flow|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
532981|NCT00813709|P1|Participant Flow|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
532982|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
532983|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
532984|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
532985|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
532986|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
532987|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
532988|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533601|NCT00806624|P2|Participant Flow|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
532990|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
532991|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
532992|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
532993|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
532994|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
532995|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
532996|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
532997|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
532998|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533058|NCT00813709|E2|Reported Event|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
533068|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533602|NCT00806624|P1|Participant Flow|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
532999|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533000|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533001|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533002|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533003|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533004|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533005|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533006|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (6 participants from DB converted to CDMS and switched to OL period over course of this study)
533007|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (10 participants from DB converted to CDMS and switched to OL period over course of this study)
533069|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
533008|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (4 participants from DB converted to CDMS and switched to OL period over course of this study)
533009|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (6 participants from DB converted to CDMS and switched to OL period over course of this study)
533010|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (10 participants from DB converted to CDMS and switched to OL period over course of this study)
533011|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (4 participants from DB converted to CDMS and switched to OL period over course of this study)
533012|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533013|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533014|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533015|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533016|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533070|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533017|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
533018|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
533019|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
533020|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
533021|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
533022|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
533023|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
533024|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533025|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533026|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533027|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533028|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533071|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
533029|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533030|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533031|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533032|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533033|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533034|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533035|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533036|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533037|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533059|NCT00813709|E1|Reported Event|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
533060|NCT00813748|B3|Baseline|Total|Total of all reporting groups
533603|NCT00806624|O3|Outcome|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
533038|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533039|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533040|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533041|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533042|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533043|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533044|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533045|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533046|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533061|NCT00813748|B2|Baseline|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
533062|NCT00813748|B1|Baseline|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533604|NCT00806624|O2|Outcome|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
533047|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533048|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533049|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533050|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533051|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533052|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533053|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
533054|NCT00813709|E6|Reported Event|RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
533055|NCT00813709|E5|Reported Event|RNF 44 Mcg Once Weekly /OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
533056|NCT00813709|E4|Reported Event|Placebo/RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
533057|NCT00813709|E3|Reported Event|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
543866|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
533072|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533073|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533074|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533075|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533076|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533077|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533078|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533079|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533080|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533081|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533082|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533083|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533084|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533085|NCT00813748|E4|Reported Event|Skin Test Substudy: Omalizumab Controls – Without Anaphylaxis|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions and were from the same site or region for their matched anaphylaxis case participant.
533086|NCT00813748|E3|Reported Event|Skin Test Substudy: Omalizumab Cases – With Anaphylaxis|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533087|NCT00813748|E2|Reported Event|Observational Study: Omalizumab Controls – Without Anaphylaxis|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions and were from the same site or region for their matched anaphylaxis case participant.
533088|NCT00813748|E1|Reported Event|Observational Study: Omalizumab Cases – With Anaphylaxis|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
533089|NCT00813761|B3|Baseline|Total|Total of all reporting groups
533090|NCT00813761|B2|Baseline|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533091|NCT00813761|B1|Baseline|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533092|NCT00813761|P4|Participant Flow|Proclear CL and Clear Care LCS|Proclear contact lens and Clear Care lens care solution
533093|NCT00813761|P3|Participant Flow|02Optix CL and Clear Care LCS|O2Optix contact lens and Clear Care lens care solution
533094|NCT00813761|P2|Participant Flow|Proclear CL and ReNu MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
533095|NCT00813761|P1|Participant Flow|02Optix CL and ReNu MPS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
533096|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533097|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533098|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533099|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533100|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533101|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533102|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533103|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533104|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533105|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533106|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533107|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
533108|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533109|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533110|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533111|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533112|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533113|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533114|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533115|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533116|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533117|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533118|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533119|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533120|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533121|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533122|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533123|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533124|NCT00813761|O2|Outcome|ReNU MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
533125|NCT00813761|O1|Outcome|Clear Care LCS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
533126|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533127|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533128|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533129|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533130|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533131|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533132|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533133|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533134|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
533135|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
533136|NCT00813761|O2|Outcome|ReNU Multi Purpose Solution (MPS)|All subjects assigned to ReNU MPS
533137|NCT00813761|O1|Outcome|Clear Care Lens Cleaning Solution (LCS)|All subjects assigned to Clear Care LCS
533138|NCT00813761|E4|Reported Event|Proclear CL and Clear Care LCS|Proclear contact lens and Clear Care lens care solution
533139|NCT00813761|E3|Reported Event|02Optix CL and Clear Care LCS|O2Optix contact lens and Clear Care lens care solution
533140|NCT00813761|E2|Reported Event|Proclear CL and ReNu MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose
533141|NCT00813761|E1|Reported Event|02Optix CL and ReNu MPS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
533142|NCT00813800|B1|Baseline|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
533143|NCT00813800|P1|Participant Flow|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
533605|NCT00806624|O1|Outcome|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
533144|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
533145|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
533146|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
533147|NCT00813800|E1|Reported Event|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
533148|NCT00813813|B3|Baseline|Total|Total of all reporting groups
533149|NCT00813813|B2|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533150|NCT00813813|B1|Baseline|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533151|NCT00813813|P2|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533152|NCT00813813|P1|Participant Flow|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533153|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533154|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533155|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533156|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533157|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533158|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533159|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533160|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533161|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533162|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533354|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
533163|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533164|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533165|NCT00813813|E2|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533166|NCT00813813|E1|Reported Event|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
533167|NCT00813904|B1|Baseline|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
533168|NCT00813904|P1|Participant Flow|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
533169|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
533170|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
533171|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
533172|NCT00813904|E1|Reported Event|TOTAL|
533173|NCT00813917|B3|Baseline|Total|Total of all reporting groups
533174|NCT00813917|B2|Baseline|Placebo|nonactive lookalike pill per day for 12 weeks
533175|NCT00813917|B1|Baseline|Varenicline|varenicline-1mg/day for 12 weeks
533176|NCT00813917|P2|Participant Flow|Placebo|nonactive lookalike pill per day for 12 weeks
533177|NCT00813917|P1|Participant Flow|Varenicline|varenicline-1mg/day for 12 weeks
533178|NCT00813917|O2|Outcome|Placebo|nonactive lookalike pill per day for 12 weeks
533179|NCT00813917|O1|Outcome|Varenicline|varenicline-1mg/day for 12 weeks
533180|NCT00813917|E2|Reported Event|Placebo|nonactive lookalike pill per day for 12 weeks
533181|NCT00813917|E1|Reported Event|Varenicline|varenicline-1mg/day for 12 weeks
533182|NCT00813943|B4|Baseline|Total|Total of all reporting groups
533183|NCT00813943|B3|Baseline|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
533184|NCT00813943|B2|Baseline|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533185|NCT00813943|B1|Baseline|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533186|NCT00813943|P3|Participant Flow|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
533187|NCT00813943|P2|Participant Flow|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533188|NCT00813943|P1|Participant Flow|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533189|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
533190|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533191|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533192|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
533193|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533194|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533195|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
533196|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533197|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533198|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533199|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533540|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533200|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533201|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533202|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533203|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533204|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533205|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533206|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
533207|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533208|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533209|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
533210|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533606|NCT00806624|E3|Reported Event|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
533211|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533212|NCT00813943|E3|Reported Event|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
533213|NCT00813943|E2|Reported Event|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533214|NCT00813943|E1|Reported Event|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
533215|NCT00813982|B1|Baseline|Experimental Contact Lens / Commercial Contact Lens|Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
533216|NCT00813982|P1|Participant Flow|Experimental Contact Lens / Commercial Contact Lens|Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
533217|NCT00813982|O2|Outcome|Lotrafilcon A Experimental Contact Lens|Experimental spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
533218|NCT00813982|O1|Outcome|Lotrafilcon A Commercial Contact Lens|Commercial spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
533219|NCT00813982|E2|Reported Event|Lotrafilcon A Experimental Contact Lens|Experimental spherical silicone hydrogel contact lens
533220|NCT00813982|E1|Reported Event|Lotrafilcon A Commercial Contact Lens|Commercial spherical silicone hydrogel contact lens
533221|NCT00813995|B3|Baseline|Total|Total of all reporting groups
533222|NCT00813995|B2|Baseline|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
533223|NCT00813995|B1|Baseline|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
533224|NCT00813995|P2|Participant Flow|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
533225|NCT00813995|P1|Participant Flow|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
533226|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
533227|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
533228|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
533229|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
533230|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.
533231|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.
533232|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.
533233|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.
533234|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
533235|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
533236|NCT00813995|E2|Reported Event|Placebo|
533237|NCT00813995|E1|Reported Event|Sitagliptin|
533238|NCT00806026|B7|Baseline|Total|Total of all reporting groups
533239|NCT00806026|B6|Baseline|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533334|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533240|NCT00806026|B5|Baseline|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533241|NCT00806026|B4|Baseline|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533242|NCT00806026|B3|Baseline|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533243|NCT00806026|B2|Baseline|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533244|NCT00806026|B1|Baseline|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533245|NCT00806026|P6|Participant Flow|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533246|NCT00806026|P5|Participant Flow|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533247|NCT00806026|P4|Participant Flow|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533248|NCT00806026|P3|Participant Flow|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533249|NCT00806026|P2|Participant Flow|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533250|NCT00806026|P1|Participant Flow|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533251|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533252|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533253|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533353|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
533254|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533255|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533256|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533257|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533258|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533259|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533260|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533261|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533262|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533263|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533264|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533265|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533266|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533267|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533268|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533269|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533607|NCT00806624|E2|Reported Event|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
533270|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533271|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533272|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533273|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533274|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533275|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533276|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533277|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533278|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533279|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533280|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533281|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533282|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533283|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533284|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533285|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533608|NCT00806624|E1|Reported Event|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
533286|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533287|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533288|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533289|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533290|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533291|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533292|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533293|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533294|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533295|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533296|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533297|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533298|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533299|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533300|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533301|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533609|NCT00806676|B4|Baseline|Total|Total of all reporting groups
533302|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533303|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533304|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533305|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533306|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533307|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533308|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533309|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533310|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533311|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533312|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533313|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533314|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533315|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533316|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533317|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533643|NCT00806819|B3|Baseline|Total|Total of all reporting groups
533318|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533319|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533320|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533321|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533322|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533323|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533324|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533325|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533326|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533327|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533328|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533329|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533330|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
533331|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533332|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533333|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533335|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533336|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533337|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533338|NCT00806026|E6|Reported Event|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533339|NCT00806026|E5|Reported Event|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533340|NCT00806026|E4|Reported Event|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533341|NCT00806026|E3|Reported Event|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533342|NCT00806026|E2|Reported Event|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
533343|NCT00806026|E1|Reported Event|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
533344|NCT00806078|B3|Baseline|Total|Total of all reporting groups
533345|NCT00806078|B2|Baseline|Quinine With Chocolate Pudding First|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
533346|NCT00806078|B1|Baseline|Quinine Alone First|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
533347|NCT00806078|P2|Participant Flow|Quinine With Chocolate Pudding First|Participants were randomized to receive a single dose of Quinine 648 mg (2 x 324 mg capsules) opened and mixed in 120 mL chocolate pudding after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose. Following a 7 day wash out period, all participants were given Quinine 648 mg (2 x 324 mg) as intact capsules under similar conditions.
533348|NCT00806078|P1|Participant Flow|Quinine Alone First|Participants were randomized to receive a single dose of quinine 648 mg (2 x 324 mg) as intact capsules after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize quinine pharmacokinetics after this dose. Following a 7 day wash out period, all participants were given quinine 648 mg (2 x 324 mg) as capsules opened and their contents mixed in 120 mL chocolate pudding under similar conditions.
533349|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
533350|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
533351|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
533352|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
533355|NCT00806078|E2|Reported Event|Quinine With Chocolate Pudding First|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
533356|NCT00806078|E1|Reported Event|Quinine Alone First|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
533357|NCT00806195|B5|Baseline|Total|Total of all reporting groups
533358|NCT00806195|B4|Baseline|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
533359|NCT00806195|B3|Baseline|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
533360|NCT00806195|B2|Baseline|Routine Vaccines (Non-Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Non-Detailed - subjects who only provided SAEs and medically attended AEs."
533361|NCT00806195|B1|Baseline|MenACWY-CRM197 + Routine Vaccines (Non-Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Non-Detailed - subjects who only provided SAEs and medically attended AEs."
533362|NCT00806195|P4|Participant Flow|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Detailed - subjects who provided Reactogenicity, all AEs for 7 days, SAEs and medically attended AEs."
533363|NCT00806195|P3|Participant Flow|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
533364|NCT00806195|P2|Participant Flow|Routine Vaccines (Non-detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Non-Detailed - subjects who only provided SAEs and medically attended AEs."
533365|NCT00806195|P1|Participant Flow|MenACWY-CRM197 + Routine Vaccines (Non-detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Non-Detailed - subjects who only provided Serious Adverse Events (SAEs) and medically attended Adverse (AE)."
533366|NCT00806195|O2|Outcome|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs."
533367|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs."
533385|NCT00806234|B2|Baseline|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.
Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
533368|NCT00806195|O2|Outcome|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
533369|NCT00806195|O1|Outcome|MenACWY-CRM 197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
533370|NCT00806195|O2|Outcome|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
533371|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
533372|NCT00806195|O2|Outcome|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."
533373|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."
533374|NCT00806195|E2|Reported Event|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
533375|NCT00806195|E1|Reported Event|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.
Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.
All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
533376|NCT00806221|B1|Baseline|Emollient|"Skin barrier protection from birth
emollient (Cetaphil cream): Cetaphil cream applied daily from birth"
533377|NCT00806221|P1|Participant Flow|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
533378|NCT00806221|O1|Outcome|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
533379|NCT00806221|O1|Outcome|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
533380|NCT00806221|O1|Outcome|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
533381|NCT00806221|O1|Outcome|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
533382|NCT00806221|E1|Reported Event|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
533383|NCT00806234|B4|Baseline|Total|Total of all reporting groups
533384|NCT00806234|B3|Baseline|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.
Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
533541|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533386|NCT00806234|B1|Baseline|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.
Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
533387|NCT00806234|P3|Participant Flow|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.
Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
533388|NCT00806234|P2|Participant Flow|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.
Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
533389|NCT00806234|P1|Participant Flow|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.
Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
533390|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.
Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
533391|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.
Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
533392|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.
Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
533393|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.
Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
533394|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.
Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
533395|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.
Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
533396|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.
Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
533397|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.
Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
533398|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.
Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
533399|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.
Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
533400|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.
Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
533401|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.
Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
533402|NCT00806234|E3|Reported Event|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.
Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
533403|NCT00806234|E2|Reported Event|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.
Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
533503|NCT00806442|P2|Participant Flow|2 - Placebo, Then Borage Seed Oil and Echium Seed Oil|Placebo (11 g of corn oil/day) 3x day for 3 weeks followed by a 3-week washout period, then Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks.
533404|NCT00806234|E1|Reported Event|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.
Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
533405|NCT00806260|B7|Baseline|Total|Total of all reporting groups
533406|NCT00806260|B6|Baseline|Alcohol Placebo Only|Subject in this study arm only participated in period 1 and were given alcohol placebo.
533407|NCT00806260|B5|Baseline|Alcohol Only|Subjects in this study arm only participated in period 1 and were given alcohol.
533408|NCT00806260|B4|Baseline|Alcohol Placebo, VI-0521 Then VI-0521 Placebo|Participants in this study arm were given alcohol placebo in period 1, VI-0521 in period 2 and VI-0521 placebo in period 3.
533409|NCT00806260|B3|Baseline|Alcohol Placebo, VI-0521 Placebo Then VI-0521|Participants in this study arm were given alcohol placebo in period 1, VI-0521-placebo in period 2 and VI-0521 in period 3.
533410|NCT00806260|B2|Baseline|Alcohol, VI-0521 Then VI-0521 Placebo|Participants in this study arm were given alcohol in period 1, VI-0521 in period 2 and VI-0521-placebo in period 3.
533411|NCT00806260|B1|Baseline|Alcohol, VI-0521 Placebo Then VI-0521|Participants in this study arm were given alcohol in period 1, VI-0521 placebo in period 2 and VI-0521 in period 3.
533412|NCT00806260|P6|Participant Flow|Alcohol-placebo Only|Alcohol-placebo was administered during period one after which the subject's participation ended.
533413|NCT00806260|P5|Participant Flow|Alcohol Only|Alcohol was administered during period one after which the subject's participation ended.
533414|NCT00806260|P4|Participant Flow|Alcohol-placebo, VI-0521 Then VI-0521-placebo|Alcohol-placebo was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
533415|NCT00806260|P3|Participant Flow|Alcohol-placebo, VI-0521-placebo Then VI-0521|Alcohol-placebo was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
533416|NCT00806260|P2|Participant Flow|Alcohol, VI-0521 Then VI-0521 Placebo|Alcohol was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
533417|NCT00806260|P1|Participant Flow|Alcohol, VI-0521 Placebo Then VI-0521|Alcohol was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
533418|NCT00806260|O4|Outcome|Period 3 VI-0521|phentermine/topiramate
533419|NCT00806260|O3|Outcome|Period 3 VI-0521-placebo|placebo
533420|NCT00806260|O2|Outcome|Period 2 VI-0521|phentermine/topiramate
533421|NCT00806260|O1|Outcome|Period 2 VI-0521-placebo|Placebo
533422|NCT00806260|O2|Outcome|Period 1 Alcohol|Alcohol
533423|NCT00806260|O1|Outcome|Period 1 Alcohol-placebo|fruit juice
533424|NCT00806260|E4|Reported Event|Period 2 and 3 Qnexa|The total number of subjects that were given VI-0521 was 41. 2 subjects were excluded from the analysis, one due to failing a drug/alcohol screen and the other due to pregnancy. Excluding these two subjects leaves 39 subjects in the analyzed ITT population.
533425|NCT00806260|E3|Reported Event|Period 2 and 3 Placebo|Total number of subjects that were given VI-0521 placebo was 43. 1 subject was excluded from the analysis due to failing a drug/alcohol screen leaving 42 subjects in the ITT population.
533426|NCT00806260|E2|Reported Event|Period 1 Alcohol|
533427|NCT00806260|E1|Reported Event|Period 1 Placebo|
533428|NCT00806351|B3|Baseline|Total|Total of all reporting groups
533429|NCT00806351|B2|Baseline|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant’s weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533430|NCT00806351|B1|Baseline|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533431|NCT00806351|P2|Participant Flow|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533484|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
533485|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
533432|NCT00806351|P1|Participant Flow|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533433|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533434|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533435|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533436|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533437|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533438|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533439|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533440|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533486|NCT00806416|B3|Baseline|Total|Total of all reporting groups
533487|NCT00806416|B2|Baseline|Part II|2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
533488|NCT00806416|B1|Baseline|Part I|70 mg alendronate/2800-IU vitamin D3 combination tablet; 70 mg alendronate tablet
533489|NCT00806416|P4|Participant Flow|Vitamin D Then Alendronate/Vitamin D Combination|2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
533441|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533442|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533443|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533444|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533445|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533446|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533447|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533448|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533449|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533490|NCT00806416|P3|Participant Flow|Alendronate/Vitamin D Combination Then Vitamin D|70 mg alendronate/2800-IU vitamind D3 combination tablet; 2800-IU vitamin D3 tablet
533491|NCT00806416|P2|Participant Flow|Alendronate Then Alendronate/Vitamin D Combination|70 mg alendronate tablet; 70 mg alendronate/2800-IU vitamind D3 comination tablet
533492|NCT00806416|P1|Participant Flow|Alendronate/Vitamin D Combination Then Alendronate|70 mg alendronate/2800-IU (international unit) vitamin D3 (cholecalciferol) combination tablet; 70 mg alendronate tablet
533450|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533451|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533452|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533453|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533454|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533455|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533456|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533457|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533458|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533493|NCT00806416|O2|Outcome|Vitamin D|2800-IU vitamin D3 tablet
533494|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
533495|NCT00806416|O2|Outcome|Vitamin D|2800-IU vitamin D3 tablet
533496|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
533497|NCT00806416|O2|Outcome|Alendronate|70 mg alendronate tablet
533459|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533460|NCT00806351|E2|Reported Event|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant’s weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533461|NCT00806351|E1|Reported Event|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
533462|NCT00806390|B3|Baseline|Total|Total of all reporting groups
533463|NCT00806390|B2|Baseline|Control|Not receiving metoprolol
533464|NCT00806390|B1|Baseline|Metoprolol|"Receiving metoprolol
Metoprolol: Metroprolol tartrate titrated up"
533465|NCT00806390|P2|Participant Flow|Control|Not receiving metoprolol
533466|NCT00806390|P1|Participant Flow|Metoprolol|"Receiving metoprolol
Metoprolol: Metroprolol tartrate titrated up"
533467|NCT00806390|O2|Outcome|Control|Not receiving metoprolol
533468|NCT00806390|O1|Outcome|Metoprolol|"Receiving metoprolol
Metoprolol: Metroprolol tartrate titrated up"
533469|NCT00806390|E2|Reported Event|Control|Not receiving metoprolol
533470|NCT00806390|E1|Reported Event|Metoprolol|"Receiving metoprolol
Metoprolol: Metroprolol tartrate titrated up"
533471|NCT00806403|B3|Baseline|Total|Total of all reporting groups
533472|NCT00806403|B2|Baseline|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
533473|NCT00806403|B1|Baseline|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
533474|NCT00806403|P2|Participant Flow|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
533475|NCT00806403|P1|Participant Flow|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
533476|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
533477|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
533478|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
533479|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
533480|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
533481|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
533482|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
533483|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
533498|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
533504|NCT00806442|P1|Participant Flow|1 - Borage Seed Oil and Echium Seed Oil, Then Placebo|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks followed a 3-week washout period, then Placebo (11 g/day corn oil) 3x day for 3 weeks.
533505|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
533506|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
533507|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
533508|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
533509|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
533510|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
533511|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
533512|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
533513|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
533514|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
533515|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
533516|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
533517|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
533518|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
533519|NCT00806442|E4|Reported Event|Washout After Placebo|Washout period between first (placebo) and second (plant seed oil) treatment assignments
533520|NCT00806442|E3|Reported Event|Washout After Plant Seed Oil|Washout period between first (plant seed oil) and second (placebo) treatment assignments
533521|NCT00806442|E2|Reported Event|Placebo|Placebo (11 g of corn oil/day)
533522|NCT00806442|E1|Reported Event|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
533523|NCT00806494|B1|Baseline|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533524|NCT00806494|P1|Participant Flow|Fesoterodine|Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533525|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533526|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533527|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533528|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533529|NCT00806494|O1|Outcome|Fesoteridine|Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533530|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533531|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533532|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533533|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533534|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533535|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533536|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533537|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533538|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533539|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533843|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533542|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533543|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533544|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533545|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533546|NCT00806494|E1|Reported Event|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
533547|NCT00806546|B1|Baseline|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
533548|NCT00806546|P1|Participant Flow|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
533549|NCT00806546|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
533550|NCT00806546|E1|Reported Event|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
533551|NCT00806585|B6|Baseline|Total|Total of all reporting groups
533552|NCT00806585|B5|Baseline|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
533553|NCT00806585|B4|Baseline|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533554|NCT00806585|B3|Baseline|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533555|NCT00806585|B2|Baseline|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533556|NCT00806585|B1|Baseline|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533557|NCT00806585|P5|Participant Flow|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
533558|NCT00806585|P4|Participant Flow|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533559|NCT00806585|P3|Participant Flow|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533560|NCT00806585|P2|Participant Flow|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533561|NCT00806585|P1|Participant Flow|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533562|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
533563|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533564|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533565|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533566|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533567|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
533568|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533569|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533570|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533571|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533572|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
533573|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533574|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533575|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533576|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533577|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
533578|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533579|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533580|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533581|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533582|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
533583|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533584|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533585|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533586|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533587|NCT00806585|E5|Reported Event|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
533588|NCT00806585|E4|Reported Event|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533589|NCT00806585|E3|Reported Event|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533590|NCT00806585|E2|Reported Event|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
533591|NCT00806585|E1|Reported Event|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
533592|NCT00806598|B1|Baseline|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF
Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.
G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.
Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days
Aplastic anemia patients receive 3.5 mg/kg/day for 5 days
MDS patients <55 years receive 3.5 mg/kg/day for 5 days
MDS patients >55 years receive 2.5 mg/kg/day for 5 days
Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
533593|NCT00806598|P1|Participant Flow|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF
Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.
G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.
Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days
Aplastic anemia patients receive 3.5 mg/kg/day for 5 days
MDS patients <55 years receive 3.5 mg/kg/day for 5 days
MDS patients >55 years receive 2.5 mg/kg/day for 5 days
Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
533594|NCT00806598|O1|Outcome|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + Granulocyte Colony stimulating factor (G-CSF
Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.
G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.
Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days
Aplastic anemia patients receive 3.5 mg/kg/day for 5 days
MDS patients <55 years receive 3.5 mg/kg/day for 5 days
MDS patients >55 years receive 2.5 mg/kg/day for 5 days
Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
533595|NCT00806598|E1|Reported Event|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF
Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.
G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.
Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days
Aplastic anemia patients receive 3.5 mg/kg/day for 5 days
MDS patients <55 years receive 3.5 mg/kg/day for 5 days
MDS patients >55 years receive 2.5 mg/kg/day for 5 days
Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
533596|NCT00806624|B4|Baseline|Total|Total of all reporting groups
533610|NCT00806676|B3|Baseline|3. Kidney Transplant Recipient|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
533611|NCT00806676|B2|Baseline|2. ESRD (Dialysis)|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
533612|NCT00806676|B1|Baseline|1. Chronic Kidney Disease, NKF Stage 1-4|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
533613|NCT00806676|P3|Participant Flow|3. Kidney Transplant Recipient|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
533614|NCT00806676|P2|Participant Flow|2. ESRD (Dialysis)|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
533615|NCT00806676|P1|Participant Flow|1. Chronic Kidney Disease, NKF Stage 1-4|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
533616|NCT00806676|O4|Outcome|HPV 18|
533617|NCT00806676|O3|Outcome|HPV 16|
533618|NCT00806676|O2|Outcome|HPV 11|
533619|NCT00806676|O1|Outcome|HPV 6|HPV genotype
533620|NCT00806676|O4|Outcome|HPV 18|
533621|NCT00806676|O3|Outcome|HPV 16|
533622|NCT00806676|O2|Outcome|HPV 11|
533623|NCT00806676|O1|Outcome|HPV 6|HPV genotype
533624|NCT00806676|O4|Outcome|HPV 18|
533625|NCT00806676|O3|Outcome|HPV 16|
533626|NCT00806676|O2|Outcome|HPV 11|
533627|NCT00806676|O1|Outcome|HPV 6|HPV genotype
533628|NCT00806676|O4|Outcome|HPV 18|
533629|NCT00806676|O3|Outcome|HPV 16|
533630|NCT00806676|O2|Outcome|HPV 11|
533631|NCT00806676|O1|Outcome|HPV 6|HPV genotype
533632|NCT00806676|O4|Outcome|HPV 18|
533633|NCT00806676|O3|Outcome|HPV 16|
533634|NCT00806676|O2|Outcome|HPV 11|
533635|NCT00806676|O1|Outcome|HPV 6|HPV genotype
533636|NCT00806676|O4|Outcome|HPV 18|
533637|NCT00806676|O3|Outcome|HPV 16|
533638|NCT00806676|O2|Outcome|HPV 11|
533639|NCT00806676|O1|Outcome|HPV 6|HPV genotype
533640|NCT00806676|E3|Reported Event|3. Kidney Transplant Recipient|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
533641|NCT00806676|E2|Reported Event|2. ESRD (Dialysis)|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
533642|NCT00806676|E1|Reported Event|1. Chronic Kidney Disease, NKF Stage 1-4|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
533644|NCT00806819|B2|Baseline|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533645|NCT00806819|B1|Baseline|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533646|NCT00806819|P2|Participant Flow|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533647|NCT00806819|P1|Participant Flow|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533648|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533649|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533650|NCT00806819|O2|Outcome|Nintedanib 150 mg Bid Plus Pemetrexed|Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion.
533651|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533652|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533653|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533654|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533655|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533656|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533657|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533658|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533734|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533659|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533660|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533661|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533662|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533663|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533664|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533665|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533666|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533667|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533668|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533669|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533670|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533671|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533672|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533685|NCT00806988|O2|Outcome|CABG|"Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
533673|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533674|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533675|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533676|NCT00806819|E2|Reported Event|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533677|NCT00806819|E1|Reported Event|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
533678|NCT00806988|B3|Baseline|Total|Total of all reporting groups
533679|NCT00806988|B2|Baseline|CABG|"Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
533680|NCT00806988|B1|Baseline|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
The heart will be arrested with cardioplegia.
A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using"
533681|NCT00806988|P2|Participant Flow|CABG|"Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
533682|NCT00806988|P1|Participant Flow|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
The heart will be arrested with cardioplegia.
A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using"
533683|NCT00806988|O2|Outcome|CABG|"Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
533684|NCT00806988|O1|Outcome|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
The heart will be arrested with cardioplegia.
A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using"
533732|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533733|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533686|NCT00806988|O1|Outcome|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
The heart will be arrested with cardioplegia.
A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using"
533687|NCT00806988|E2|Reported Event|CABG|"Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
533688|NCT00806988|E1|Reported Event|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
The heart will be arrested with cardioplegia.
A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using"
533689|NCT00807001|B6|Baseline|Total|Total of all reporting groups
533690|NCT00807001|B5|Baseline|IDX184 100 mg|
533691|NCT00807001|B4|Baseline|IDX184 75 mg|
533692|NCT00807001|B3|Baseline|IDX184 50 mg|
533693|NCT00807001|B2|Baseline|IDX184 25 mg|
533694|NCT00807001|B1|Baseline|Placebo|
533695|NCT00807001|P5|Participant Flow|IDX184 100 mg|
533696|NCT00807001|P4|Participant Flow|IDX184 75 mg|
533697|NCT00807001|P3|Participant Flow|IDX184 50 mg|
533698|NCT00807001|P2|Participant Flow|IDX184 25 mg|
533699|NCT00807001|P1|Participant Flow|Placebo|
533700|NCT00807001|O5|Outcome|IDX184 100 mg|
533701|NCT00807001|O4|Outcome|IDX184 75 mg|
533702|NCT00807001|O3|Outcome|IDX184 50 mg|
533703|NCT00807001|O2|Outcome|IDX184 25 mg|
533704|NCT00807001|O1|Outcome|Placebo|
533705|NCT00807001|O5|Outcome|IDX184 100 mg|
533706|NCT00807001|O4|Outcome|IDX184 75 mg|
533707|NCT00807001|O3|Outcome|IDX184 50 mg|
533708|NCT00807001|O2|Outcome|IDX184 25 mg|
533709|NCT00807001|O1|Outcome|Placebo|
533710|NCT00807001|E5|Reported Event|IDX184 100 mg|
533711|NCT00807001|E4|Reported Event|IDX184 75 mg|
533712|NCT00807001|E3|Reported Event|IDX184 50 mg|
533713|NCT00807001|E2|Reported Event|IDX184 25 mg|
533714|NCT00807001|E1|Reported Event|Placebo|
533715|NCT00807014|B3|Baseline|Total|Total of all reporting groups
533716|NCT00807014|B2|Baseline|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533717|NCT00807014|B1|Baseline|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533718|NCT00807014|P2|Participant Flow|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533719|NCT00807014|P1|Participant Flow|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533720|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533721|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533722|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533723|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533724|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533725|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533726|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533727|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533728|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533729|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533730|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533731|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533844|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
533735|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533736|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533737|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533738|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533739|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533740|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533741|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533742|NCT00807014|E2|Reported Event|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
533743|NCT00807014|E1|Reported Event|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
533744|NCT00807040|B3|Baseline|Total|Total of all reporting groups
533745|NCT00807040|B2|Baseline|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
533746|NCT00807040|B1|Baseline|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
533747|NCT00807040|P2|Participant Flow|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
533748|NCT00807040|P1|Participant Flow|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
533749|NCT00807040|O2|Outcome|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
533750|NCT00807040|O1|Outcome|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
533751|NCT00807040|O2|Outcome|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
533752|NCT00807040|O1|Outcome|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
533753|NCT00807040|E2|Reported Event|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
533754|NCT00807040|E1|Reported Event|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
533755|NCT00807092|B3|Baseline|Total|Total of all reporting groups
533756|NCT00807092|B2|Baseline|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533793|NCT00807209|O3|Outcome|Low Dose SKY0402|Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
533757|NCT00807092|B1|Baseline|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533758|NCT00807092|P2|Participant Flow|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533759|NCT00807092|P1|Participant Flow|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533760|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533761|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533762|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533763|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533764|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533765|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533766|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533767|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533768|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533769|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533770|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533771|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
534284|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
533772|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533773|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533774|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533775|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533776|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533777|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533778|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533779|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533780|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533781|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533782|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533783|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533784|NCT00807092|E2|Reported Event|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533785|NCT00807092|E1|Reported Event|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
533786|NCT00807209|B4|Baseline|Total|Total of all reporting groups
533787|NCT00807209|B3|Baseline|Low Dose SKY0402|
533788|NCT00807209|B2|Baseline|Standard of Care|
533789|NCT00807209|B1|Baseline|High Dose SKY0402|
533790|NCT00807209|P3|Participant Flow|Low Dose SKY0402|
533791|NCT00807209|P2|Participant Flow|Standard of Care|
533792|NCT00807209|P1|Participant Flow|High Dose SKY0402|
533794|NCT00807209|O2|Outcome|Standard of Care|Bupivacaine HCl solution (1.25 mg/mL) and epinephrine (5 mcg/mL) administered via an epidural catheter at a concentration of 0.125% (1.25 mg/mL) at a rate of 8 cc per hour
533795|NCT00807209|O1|Outcome|High Dose SKY0402|Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
533796|NCT00807209|E3|Reported Event|Low Dose SKY0402|
533797|NCT00807209|E2|Reported Event|Standard of Care|
533798|NCT00807209|E1|Reported Event|High Dose SKY0402|
533799|NCT00807235|B3|Baseline|Total|Total of all reporting groups
533800|NCT00807235|B2|Baseline|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533801|NCT00807235|B1|Baseline|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533802|NCT00807235|P2|Participant Flow|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533803|NCT00807235|P1|Participant Flow|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533804|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533805|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533806|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533807|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533808|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533809|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533810|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533811|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533812|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533813|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533814|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533815|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533816|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533817|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533818|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533819|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533820|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533821|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533822|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533823|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533824|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533825|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533826|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533827|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533828|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533829|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533830|NCT00807235|E2|Reported Event|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
533831|NCT00807235|E1|Reported Event|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
533832|NCT00807248|B5|Baseline|Total|Total of all reporting groups
533833|NCT00807248|B4|Baseline|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
533834|NCT00807248|B3|Baseline|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
533835|NCT00807248|B2|Baseline|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533836|NCT00807248|B1|Baseline|Placebo (Orally, Once Daily)|
533837|NCT00807248|P4|Participant Flow|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
533838|NCT00807248|P3|Participant Flow|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
533839|NCT00807248|P2|Participant Flow|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533840|NCT00807248|P1|Participant Flow|Placebo (Orally, Once Daily)|
533845|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
533846|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
533847|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533848|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
533849|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
533850|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
533851|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533852|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
533853|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
533854|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
533855|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533856|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
533857|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
533858|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
533859|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533860|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
533861|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
533862|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
533863|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533864|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
533865|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
533866|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
533867|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533868|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
533869|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
533870|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
533871|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533872|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
533873|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
533874|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
533875|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533876|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
533877|NCT00807248|E4|Reported Event|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
533878|NCT00807248|E3|Reported Event|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
533879|NCT00807248|E2|Reported Event|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
533880|NCT00807248|E1|Reported Event|Placebo (Orally, Once Daily)|
533881|NCT00807365|B1|Baseline|GHRH|"Growth Hormone-Releasing Hormone
GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
533882|NCT00807365|P1|Participant Flow|GHRH|"Growth Hormone-Releasing Hormone
GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 Post Meridian (PM), 1:00 Ante Meridian (AM), 3:00 AM, & 5:00 AM for 6 months."
533883|NCT00807365|O1|Outcome|GHRH|"Growth Hormone-Releasing Hormone
GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
533884|NCT00807365|E1|Reported Event|GHRH|"Growth Hormone-Releasing Hormone
GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
533885|NCT00807456|B1|Baseline|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
533886|NCT00807456|P1|Participant Flow|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
533887|NCT00807456|O1|Outcome|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
533888|NCT00807456|E1|Reported Event|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
533889|NCT00807560|B3|Baseline|Total|Total of all reporting groups
533890|NCT00807560|B2|Baseline|NEC-control|Nutritional Educational Control Condition
533891|NCT00807560|B1|Baseline|FBT-PO|Family Based Therapy for Pediatric Overweight
533892|NCT00807560|P2|Participant Flow|NEC- Control|"Nutritional Educational Control Condition (NEC).
NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks."
533893|NCT00807560|P1|Participant Flow|FBT-PO|"Family Based Therapy for Pediatric Overweight.
FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases."
533894|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533895|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533896|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533897|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533898|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533899|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533900|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533901|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533902|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533903|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533904|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533905|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533906|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533907|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533908|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533909|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533910|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533911|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533912|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533913|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533914|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533915|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533916|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533917|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533918|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533919|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533920|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533921|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533922|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
533923|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
533924|NCT00807560|E2|Reported Event|NEC- Control|"Nutritional Educational Control Condition (NEC).
NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks."
533925|NCT00807560|E1|Reported Event|FBT-PO|"Family Based Therapy for Pediatric Overweight.
FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases."
533926|NCT00807573|B1|Baseline|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced NSCLC. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1, 15 and 19.
533927|NCT00807573|P1|Participant Flow|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
533928|NCT00807573|O1|Outcome|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
533929|NCT00807573|E1|Reported Event|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
533930|NCT00814138|B3|Baseline|Total|Total of all reporting groups
533931|NCT00814138|B2|Baseline|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533932|NCT00814138|B1|Baseline|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533933|NCT00814138|P2|Participant Flow|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533934|NCT00814138|P1|Participant Flow|1 - Methotrexate (2.5 mg)|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533935|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533936|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533937|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533938|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533939|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533940|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533941|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533942|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533943|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533944|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533945|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg/day for 2 weeks and then increase to 15mg/day for 2 weeks and then 20mg/day until the end of the study
533946|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg/day for 2 weeks and then increase to 15mg/day for 2 weeks and then 20mg/day until the end of the study
533947|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533948|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
533949|NCT00814138|E2|Reported Event|Placebo Group - Adverse Events|Reported the number of adverse events in the group randomized to placebo
533950|NCT00814138|E1|Reported Event|Methotrexate Group - Adverse Events|Reported the number of adverse events in the group randomized to methotrexate.
533951|NCT00814164|B1|Baseline|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine: IV
daunorubicin hydrochloride: IV
cytogenetic analysis: Correlative study
protein expression analysis: Correlative Study
immunologic technique: Correlative Study
pharmacological study: Correlative Study"
533952|NCT00814164|P1|Participant Flow|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine: IV
daunorubicin hydrochloride: IV
cytogenetic analysis: Correlative study
protein expression analysis: Correlative Study
immunologic technique: Correlative Study
pharmacological study: Correlative Study"
533953|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine: IV
daunorubicin hydrochloride: IV
cytogenetic analysis: Correlative study
protein expression analysis: Correlative Study
immunologic technique: Correlative Study
pharmacological study: Correlative Study"
533954|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine: IV
daunorubicin hydrochloride: IV
cytogenetic analysis: Correlative study
protein expression analysis: Correlative Study
immunologic technique: Correlative Study
pharmacological study: Correlative Study"
533955|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine: IV
daunorubicin hydrochloride: IV
cytogenetic analysis: Correlative study
protein expression analysis: Correlative Study
immunologic technique: Correlative Study
pharmacological study: Correlative Study"
533956|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine: IV
daunorubicin hydrochloride: IV
cytogenetic analysis: Correlative study
protein expression analysis: Correlative Study
immunologic technique: Correlative Study
pharmacological study: Correlative Study"
533957|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine: IV
daunorubicin hydrochloride: IV
cytogenetic analysis: Correlative study
protein expression analysis: Correlative Study
immunologic technique: Correlative Study
pharmacological study: Correlative Study"
533958|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine: IV
daunorubicin hydrochloride: IV
cytogenetic analysis: Correlative study
protein expression analysis: Correlative Study
immunologic technique: Correlative Study
pharmacological study: Correlative Study"
533959|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine: IV
daunorubicin hydrochloride: IV
cytogenetic analysis: Correlative study
protein expression analysis: Correlative Study
immunologic technique: Correlative Study
pharmacological study: Correlative Study"
533960|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine: IV
daunorubicin hydrochloride: IV
cytogenetic analysis: Correlative study
protein expression analysis: Correlative Study
immunologic technique: Correlative Study
pharmacological study: Correlative Study"
533961|NCT00814164|E1|Reported Event|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine: IV
daunorubicin hydrochloride: IV
cytogenetic analysis: Correlative study
protein expression analysis: Correlative Study
immunologic technique: Correlative Study
pharmacological study: Correlative Study"
533962|NCT00814177|B3|Baseline|Total|Total of all reporting groups
533963|NCT00814177|B2|Baseline|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
533964|NCT00814177|B1|Baseline|No Change|Intervention Drug warfarin no change in the dose is performed
533965|NCT00814177|P2|Participant Flow|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
533966|NCT00814177|P1|Participant Flow|No Change|Intervention Drug warfarin no change in the dose is performed
533967|NCT00814177|O2|Outcome|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
533968|NCT00814177|O1|Outcome|No Change|Intervention Drug warfarin no change in the dose is performed
533969|NCT00814177|E2|Reported Event|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
533970|NCT00814177|E1|Reported Event|No Change|Intervention Drug warfarin no change in the dose is performed
533971|NCT00814255|B4|Baseline|Total|Total of all reporting groups
533972|NCT00814255|B3|Baseline|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID
galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID"
533973|NCT00814255|B2|Baseline|Conservative Medical Therapy|"Conservative medical therapy (lisinopril, losartan, atorvastatin)
Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
533974|NCT00814255|B1|Baseline|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
533975|NCT00814255|P3|Participant Flow|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID
galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID
NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
533976|NCT00814255|P2|Participant Flow|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)
Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
533977|NCT00814255|P1|Participant Flow|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
533978|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID
galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID
NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
533979|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)
Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
533980|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
533981|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID
galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID
NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
533982|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)
Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
533983|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
533984|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID
galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID
NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
533985|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)
Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
533986|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
533987|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID
galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID
NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
533988|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)
Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
533989|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
533990|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID
galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID 2 out of 7"
533991|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)
Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day 2 out of 7"
533992|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days 0 out of 7"
533993|NCT00814255|E3|Reported Event|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID
galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID"
533994|NCT00814255|E2|Reported Event|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)
Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
533995|NCT00814255|E1|Reported Event|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab
Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
533996|NCT00814307|B5|Baseline|Total|Total of all reporting groups
533997|NCT00814307|B4|Baseline|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
533998|NCT00814307|B3|Baseline|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
533999|NCT00814307|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534000|NCT00814307|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534001|NCT00814307|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534002|NCT00814307|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534003|NCT00814307|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534004|NCT00814307|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534005|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534006|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534007|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534008|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534009|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534010|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534011|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534012|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534013|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534014|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534015|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534016|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534017|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534018|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534019|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534020|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534021|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534022|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534023|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534024|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534025|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534026|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534027|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534028|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534029|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534030|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534031|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534032|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534033|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534034|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534035|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534036|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534037|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534038|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534039|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534040|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534041|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534042|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534043|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534044|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534045|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534046|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534047|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534048|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534049|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534050|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534051|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534052|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534053|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534054|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534055|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534056|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534057|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534285|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
534058|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534059|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534060|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534061|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534062|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534063|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534064|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534065|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534066|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534067|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534068|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534069|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534070|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534071|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534072|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534073|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534074|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534075|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534076|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534077|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534078|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534079|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534080|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534081|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534082|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534083|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534084|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534085|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534086|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534087|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534088|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534089|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534090|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534091|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534092|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534093|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534094|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534095|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534096|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534097|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534098|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534099|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534100|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534101|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534102|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534103|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534104|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534105|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534106|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534107|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534108|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534109|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534110|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534111|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534112|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534113|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534114|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534115|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534116|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534117|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534118|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534119|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534120|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534121|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534122|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534123|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534124|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534125|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534126|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534127|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534128|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534129|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534130|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534131|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534132|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534133|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534134|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534135|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534136|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534137|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534138|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534139|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534140|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534141|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534142|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534143|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534144|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534145|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
534146|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534147|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534148|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534149|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534150|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534151|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534152|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534153|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534154|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534155|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534156|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534286|NCT00814320|O2|Outcome|Participants ≥12 Years|
534157|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
534158|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
534159|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
534160|NCT00814307|E5|Reported Event|CP-690550 10 mg (Post Month 3)|CP-690550 10 mg tablet orally twice daily from Month 3 to Month 6.
534161|NCT00814307|E4|Reported Event|CP-690550 5 mg (Post Month 3)|CP-690550 5 mg tablet orally twice daily from Month 3 to Month 6.
534162|NCT00814307|E3|Reported Event|Placebo (Up To Month 3)|Matching placebo tablet orally twice daily up to Month 3.
534163|NCT00814307|E2|Reported Event|CP-690550 10 mg (Up To Month 3)|CP-690550 10 mg tablet orally twice daily up to Month 3.
534164|NCT00814307|E1|Reported Event|CP-690550 5 mg (Up To Month 3)|CP-690550 5 mg tablet orally twice daily up to Month 3.
534165|NCT00814320|B3|Baseline|Total|Total of all reporting groups
534166|NCT00814320|B2|Baseline|12 Years and Older|"EPOCH 1: Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of Subcutaneous (SC) infusions Recombinant human hyaluronidase (rHuPH20) + immune globulin intravenous (IGIV).
Participants who previously participated in Study 160601 entered this study at Epoch 2. PK data collected during IV treatment in Study 160601 were used for comparison with PK data from SC treatment during this study (160603).
EPOCH 2: (ramp-up and After ramp-up). Participants were treated SC with GAMMAGARD LIQUID/KIOVIG at 108% of IV dose from Epoch 1 or Study 160601. 108% was derived from PK data from Study 160602. Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG.
Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment (ramp-up), to allow participants to adjust to increasing volume administered SC. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
534167|NCT00814320|B1|Baseline|2 to <12 Years|"The same as the other study arm/group (please see 12 Years and Older, due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children."
534168|NCT00814320|P2|Participant Flow|12 Years and Older|"EPOCH 1: Pharmacokinetics (PK) of intravenous (IV) administration of immune globulin intravenous (IGIV), 10%.
Participants who previously participated in Study 160601 entered this study directly to Epoch 2 ramp-up. PK data collected during IV treatment in Study 160601 was compared with PK data from subcutaneous (SC) treatment during this study.
EPOCH 2 RAMP-UP (ramp-up):Treatment intervals/ doses used for initial SC infusions of IGIV, 10% were slowly increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. Prior to SC infusions, recombinant human hyaluronidase (rHuPH20) was administered at a minimum dose of 75 U/g IgG.
EPOCH 2 after RAMP-UP: Participants were treated SC with IGIV, 10% with rHuPH20 at 108% of IV dose from Epoch 1 (or from study 160601). Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG.
Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
534169|NCT00814320|P1|Participant Flow|2 to <12 Years|"The same as the other study arm/group (please see 12 Years and Older, due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children."
534170|NCT00814320|O1|Outcome|Participants in Safety Data Analysis Set|Participants exposed to either or both study drugs
534171|NCT00814320|O1|Outcome|Participants in Safety Data Analysis Set|Participants exposed to either or both study drugs
534172|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534173|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534174|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534175|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534176|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534177|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534178|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 With Ramp-up|
534179|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534180|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534181|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534182|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534183|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534184|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534185|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534186|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534187|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534188|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534189|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534190|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534191|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534192|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534193|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534194|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534195|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534196|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534197|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534198|NCT00814320|O2|Outcome|Study Epoch 2|Epoch 2 - SC administration of IGIV, 10% with rHuPH20 after ramp-up
534199|NCT00814320|O1|Outcome|Study Epoch 1|Epoch 1 - IV administration of IGIV, 10%
534200|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534201|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534202|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up|
534203|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534204|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534205|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534206|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534207|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534208|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534209|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534210|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534211|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534212|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534213|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534214|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534215|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534216|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534217|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20 at Ramp-up|At start of SC administration of IGIV, 10% with rHuPH20, the first SC dose was a 1-week dose given for a 1-week interval, then if the 1 week SC infusions were tolerated, each week the interval (and dose) was increased by 1 week, until the treatment interval was the same as the interval for intravenous treatment (3 weeks or 4 weeks)
534218|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534219|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534220|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up|Includes 2 participants who withdrew during ramp-up SC and rHuPH20 administration of IGIV, 10%
534221|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534222|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534223|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534224|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534225|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534226|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534227|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534228|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534229|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534230|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534231|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534232|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534233|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534234|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534235|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534236|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534237|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534238|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
534239|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534240|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534241|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534242|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534243|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534244|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534245|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534246|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534247|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534248|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534249|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534250|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534251|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534252|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534253|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534254|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534255|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534256|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534257|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534258|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534259|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534260|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534261|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534262|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534263|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534264|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534265|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534266|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534267|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534268|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534269|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534270|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534271|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534272|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534273|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534274|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
534275|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534276|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
534277|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
534278|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
534279|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
534280|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
534281|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
534282|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
534283|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
534288|NCT00814320|O2|Outcome|SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up|
534289|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
534290|NCT00814320|O1|Outcome|Ratio IgG AUC of SC With and Without rHuPH20|Percentage Ratio of IgG AUC (dose per kg) with and without rHuPH20 for SC administration of IGIV, 10%
534291|NCT00814320|O1|Outcome|%Ratio IgG Trough Level of SC/IV|Percentage Ratio IgGTrough Level after SC administration with rHuPH20/IgG versus after IV administration of IGIV, 10% for participants aged 2 to < 12 years
534292|NCT00814320|O1|Outcome|% Ratio IgG AUC/Week of SC/ IV|Percentage Ratio of IgG AUC (/Week) after SC administration with rHuPH20/ IgG AUC (/Week) after IV administration of IGIV, 10%
534293|NCT00814320|O1|Outcome|Full Analysis Data Set (FADS)|All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
534294|NCT00814320|E2|Reported Event|SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)|"Consists of participants treated SC with IGIV, 10% at 108% of IV dose during administration of IGIV, 10%. This arm INCLUDES participants during ramp-up.
Ramp-up: Participants were treated with SC infusions of IGIV, 10% with recombinant human hyaluronidase (rHuPH20). Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC.
During SC administration of IGIV, 10% with rHuPh20, aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
534295|NCT00814320|E1|Reported Event|IV Administration of IGIV, 10%|Consists of Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of IV infusions of immune globulin intravenous (IGIV), 10%.
534296|NCT00814333|B3|Baseline|Total|Total of all reporting groups
534297|NCT00814333|B2|Baseline|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
534298|NCT00814333|B1|Baseline|Merocel Pack|"Standard of care for persons being treated for epistaxis.
Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
534299|NCT00814333|P2|Participant Flow|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
534300|NCT00814333|P1|Participant Flow|Merocel Pack|"Standard of care for persons being treated for epistaxis.
Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
534301|NCT00814333|O2|Outcome|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
534302|NCT00814333|O1|Outcome|Merocel Pack|"Standard of care for persons being treated for epistaxis.
Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
534303|NCT00814333|E2|Reported Event|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
534304|NCT00814333|E1|Reported Event|Merocel Pack|"Standard of care for persons being treated for epistaxis.
Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
534305|NCT00814346|B3|Baseline|Total|Total of all reporting groups
534306|NCT00814346|B2|Baseline|Placebo|Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients
534307|NCT00814346|B1|Baseline|EGb761 120 mg|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
534308|NCT00814346|P2|Participant Flow|Placebo|Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients
534309|NCT00814346|P1|Participant Flow|EGb761 120 mg|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
534310|NCT00814346|O2|Outcome|EGb761 120 mg (MC)|EGb761 120 mg 17 months (open phase) for MC patients
534311|NCT00814346|O1|Outcome|EGb761 120 mg (CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534312|NCT00814346|O3|Outcome|EGb761 120 mg (Open Phase)|EGb761 120 mg twice a day for 17 months (open phase) for MC and CNE patients
534313|NCT00814346|O2|Outcome|Placebo (Double-blind Phase)|Placebo 1 tablet twice a day for 4 weeks (double-blind phase) for CNE, MC and AD patients
534314|NCT00814346|O1|Outcome|EGb761 120 mg (Double-blind Phase)|EGb761 120 mg twice a day for 4 weeks (double-blind phase) for CNE, MC and AD patients
534315|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534316|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534317|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534318|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534319|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534320|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534321|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534322|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534323|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534324|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534325|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534326|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534327|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534328|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534329|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534330|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534331|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534332|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534333|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (Open phase) for MC patients
534334|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534335|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534336|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534337|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534338|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534339|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534340|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534341|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534342|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534343|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534344|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534345|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534346|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534347|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534348|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534349|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534350|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534351|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534352|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534353|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534354|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534355|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534356|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534357|NCT00814346|O4|Outcome|Placebo (MC)|Placebo 1 tablet twice a day for 4 weeks for CNE, MC and AD patients
534358|NCT00814346|O3|Outcome|EGb761 120 mg (MC)|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients
534359|NCT00814346|O2|Outcome|Placebo (CNE)|Placebo 1 tablet twice a day for 4 weeks for CNE, MC and AD patients
534360|NCT00814346|O1|Outcome|EGb761 120 mg (CNE)|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients
534361|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534362|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534363|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
534364|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534365|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patient
534366|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534367|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg 17 months (open phase) for MC patients
534368|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
534369|NCT00814346|E3|Reported Event|EGb761 120 mg (Open Phase)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC and CNE patients
534370|NCT00814346|E2|Reported Event|Placebo (Double-blind Phase)|Placebo 1 tablet twice a day for 4 weeks (double-blind phase) for CNE, MC, and AD patients
534371|NCT00814346|E1|Reported Event|EGb761 120 mg (Double-blind Phase)|EGb761 120 mg tablet twice a day for 4 weeks (double-blind phase) for CNE, MC, and AD patients
534372|NCT00814463|B1|Baseline|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.
Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
MMSE : Neurocognitive function via MMSE done every 3 months for length of study.
MRI : MRI done every 3 months for the length of the study."
534416|NCT00815347|P1|Participant Flow|All Study Participants|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
534417|NCT00815347|O2|Outcome|Bosentan|
534373|NCT00814463|P1|Participant Flow|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.
Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
MMSE : Neurocognitive function via MMSE done every 3 months for length of study.
MRI : MRI done every 3 months for the length of the study."
534374|NCT00814463|O1|Outcome|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.
Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
MMSE : Neurocognitive function via MMSE done every 3 months for length of study.
MRI : MRI done every 3 months for the length of the study."
534375|NCT00814463|E1|Reported Event|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.
Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
MMSE : Neurocognitive function via MMSE done every 3 months for length of study.
MRI : MRI done every 3 months for the length of the study."
534376|NCT00815087|B3|Baseline|Total|Total of all reporting groups
534377|NCT00815087|B2|Baseline|Home Rehabilitation Program (HRP)|"Exercise home program
Exercise home program : Daily exercise training"
534378|NCT00815087|B1|Baseline|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental
Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
534379|NCT00815087|P2|Participant Flow|Home Rehabilitation Program (HRP)|"Exercise home program
Exercise home program : Daily exercise training"
534380|NCT00815087|P1|Participant Flow|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental
Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
534381|NCT00815087|O2|Outcome|Home Rehabilitation Program (HRP)|"Exercise home program
Exercise home program : Daily exercise training"
534382|NCT00815087|O1|Outcome|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental
Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
534383|NCT00815087|E2|Reported Event|Home Rehabilitation Program (HRP)|"Exercise home program
Exercise home program : Daily exercise training"
534384|NCT00815087|E1|Reported Event|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental
Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
534385|NCT00815191|B3|Baseline|Total|Total of all reporting groups
534386|NCT00815191|B2|Baseline|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.
a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
534387|NCT00815191|B1|Baseline|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.
vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
534388|NCT00815191|P2|Participant Flow|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.
a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
534389|NCT00815191|P1|Participant Flow|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.
vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
534390|NCT00815191|O2|Outcome|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.
a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
534391|NCT00815191|O1|Outcome|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.
vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
534392|NCT00815191|E2|Reported Event|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.
a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
534418|NCT00815347|O1|Outcome|Placebo|
534419|NCT00815347|O2|Outcome|Bosentan|
534420|NCT00815347|O1|Outcome|Placebo|
534393|NCT00815191|E1|Reported Event|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.
vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
534394|NCT00815295|B4|Baseline|Total|Total of all reporting groups
534395|NCT00815295|B3|Baseline|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
534396|NCT00815295|B2|Baseline|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg was administered orally twice daily.
534397|NCT00815295|B1|Baseline|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg was administered orally twice daily.
534398|NCT00815295|P3|Participant Flow|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
534399|NCT00815295|P2|Participant Flow|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg was administered orally twice daily.
534400|NCT00815295|P1|Participant Flow|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg was administered orally twice daily.
534401|NCT00815295|O1|Outcome|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
534402|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
534403|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
534404|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
534405|NCT00815295|O1|Outcome|Phase 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg or 400 mg was administered orally twice daily. The dose of sorafenib was escalated from 200 mg to 400 mg in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the maximum dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT).
534406|NCT00815295|E3|Reported Event|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
534407|NCT00815295|E2|Reported Event|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg/m2 was administered orally twice daily.
534408|NCT00815295|E1|Reported Event|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg/m2 was administered orally twice daily.
534409|NCT00815308|B1|Baseline|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
534410|NCT00815308|P1|Participant Flow|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
534411|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
534412|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
534413|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
534414|NCT00815308|E1|Reported Event|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
534415|NCT00815347|B1|Baseline|All Study Participants|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
534421|NCT00815347|O2|Outcome|Bosentan|
534422|NCT00815347|O1|Outcome|Placebo|
534423|NCT00815347|O2|Outcome|Bosentan|
534424|NCT00815347|O1|Outcome|Placebo|
534429|NCT00815347|E2|Reported Event|Placebo|Placebo orally, twice a day for four weeks.
534430|NCT00815347|E1|Reported Event|Bosentan|Bosentan 62.5mg orally, twice a day for four weeks.
534431|NCT00815360|B3|Baseline|Total|Total of all reporting groups
534432|NCT00815360|B2|Baseline|Comparative Group 1|Intravitreal triamcinolone with macular laser
534433|NCT00815360|B1|Baseline|Treatment Group 1|ranibizumab and scatter laser
534434|NCT00815360|P2|Participant Flow|Comparative Group 1|Intravitreal triamcinolone with macular laser
534435|NCT00815360|P1|Participant Flow|Treatment Group 1|ranibizumab and scatter laser
534436|NCT00815360|O2|Outcome|Comparative Group 1|Intravitreal triamcinolone with macular laser
534437|NCT00815360|O1|Outcome|Treatment Group 1|ranibizumab and scatter laser
534438|NCT00815360|O2|Outcome|Comparative Group 1|Intravitreal triamcinolone with macular laser
534439|NCT00815360|O1|Outcome|Treatment Group 1|ranibizumab and scatter laser
534440|NCT00815360|E2|Reported Event|Comparative Group 1|Intravitreal triamcinolone acetonide and macular laser
534441|NCT00815360|E1|Reported Event|Treatment Group 1|Intravitreal ranibizumab and peripheral laser
534442|NCT00815490|B3|Baseline|Total|Total of all reporting groups
534443|NCT00815490|B2|Baseline|Validation|Group of subjects in whom the final algorithm is tested.
534444|NCT00815490|B1|Baseline|Calibration|Initial group of subjects on whom the test algorithm is developed.
534445|NCT00815490|P2|Participant Flow|Validation|Group of subjects in whom the final algorithm is tested.
534446|NCT00815490|P1|Participant Flow|Calibration|Initial group of subjects on whom the test algorithm is developed.
534447|NCT00815490|O2|Outcome|Validation|Group of subjects in whom the final algorithm is tested.
534448|NCT00815490|O1|Outcome|Calibration|Initial group of subjects on whom the test algorithm is developed.
534449|NCT00815490|E2|Reported Event|Validation|Group of subjects in whom the final algorithm is tested.
534450|NCT00815490|E1|Reported Event|Calibration|Initial group of subjects on whom the test algorithm is developed.
534451|NCT00815516|B3|Baseline|Total|Total of all reporting groups
534452|NCT00815516|B2|Baseline|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534453|NCT00815516|B1|Baseline|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534454|NCT00815516|P2|Participant Flow|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534455|NCT00815516|P1|Participant Flow|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534456|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534457|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534458|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534459|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534460|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534461|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534462|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534463|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534464|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534465|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534466|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534467|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534468|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534469|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534470|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534471|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534472|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534473|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534474|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534475|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534476|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534477|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534478|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534479|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534480|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534481|NCT00815516|E2|Reported Event|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534482|NCT00815516|E1|Reported Event|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
534483|NCT00815659|B1|Baseline|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534484|NCT00815659|P1|Participant Flow|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534485|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534486|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534487|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534488|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534489|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534490|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534491|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534492|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534493|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534494|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534495|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534496|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534497|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534498|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534499|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534500|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534501|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534502|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534503|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534504|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534505|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534506|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534507|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534508|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534509|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534510|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534511|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534512|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534513|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534514|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534515|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534516|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534517|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534518|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534519|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534520|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534521|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534522|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534523|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534524|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534525|NCT00815659|E1|Reported Event|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
534526|NCT00815685|B1|Baseline|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
534527|NCT00815685|P1|Participant Flow|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
534528|NCT00815685|O1|Outcome|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
534529|NCT00815685|O1|Outcome|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
534530|NCT00815685|E1|Reported Event|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
534531|NCT00815698|B3|Baseline|Total|Total of all reporting groups
534532|NCT00815698|B2|Baseline|Suture|"Suture for mesh fixation
suture: suture for mesh fixation"
534533|NCT00815698|B1|Baseline|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation
no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
534534|NCT00815698|P2|Participant Flow|Suture|"Suture for mesh fixation
suture: suture for mesh fixation"
534535|NCT00815698|P1|Participant Flow|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation
no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
534536|NCT00815698|O2|Outcome|Suture|"Suture for mesh fixation
suture: suture for mesh fixation"
534537|NCT00815698|O1|Outcome|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation
no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
534538|NCT00815698|O2|Outcome|Suture|"Suture for mesh fixation
suture: suture for mesh fixation"
534539|NCT00815698|O1|Outcome|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation
no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
534540|NCT00815698|E2|Reported Event|Suture|"Suture for mesh fixation
suture: suture for mesh fixation"
534541|NCT00815698|E1|Reported Event|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation
no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
534542|NCT00815776|B4|Baseline|Total|Total of all reporting groups
534543|NCT00815776|B3|Baseline|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
534544|NCT00815776|B2|Baseline|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
534545|NCT00815776|B1|Baseline|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
534546|NCT00815776|P3|Participant Flow|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
534547|NCT00815776|P2|Participant Flow|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
534548|NCT00815776|P1|Participant Flow|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
534549|NCT00815776|O3|Outcome|Jaw Exercise Group|This subject group received no device but was assigned to complete a study-specified jaw exercise program
534550|NCT00815776|O2|Outcome|Mouth Splint Group|This group was not part of the analysis
534551|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|This group of subjects received the Clayton Intra-aural Device
534552|NCT00815776|O3|Outcome|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
534553|NCT00815776|O2|Outcome|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
534554|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
534555|NCT00815776|O3|Outcome|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
534556|NCT00815776|O2|Outcome|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
534557|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
534558|NCT00815776|E3|Reported Event|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
534559|NCT00815776|E2|Reported Event|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
534560|NCT00815776|E1|Reported Event|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
534844|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534561|NCT00815919|B1|Baseline|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.
Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
534562|NCT00815919|P1|Participant Flow|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.
Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
534563|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.
Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
534564|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.
Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
534565|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.
Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
534566|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.
Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
534567|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.
Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
534568|NCT00815919|E1|Reported Event|Velcade (Bortezomib)|"Prednisone : Taken orally once a day. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.
bortezomib : Given intravenously once a week for the first four weeks of a five week cycle for a total of 3 cycles"
534569|NCT00816023|B5|Baseline|Total|Total of all reporting groups
534570|NCT00816023|B4|Baseline|Placebo|
534571|NCT00816023|B3|Baseline|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
534572|NCT00816023|B2|Baseline|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
534573|NCT00816023|B1|Baseline|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
534574|NCT00816023|P4|Participant Flow|Placebo|
534575|NCT00816023|P3|Participant Flow|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
534576|NCT00816023|P2|Participant Flow|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
534577|NCT00816023|P1|Participant Flow|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
534578|NCT00816023|O4|Outcome|Placebo|
534579|NCT00816023|O3|Outcome|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
534580|NCT00816023|O2|Outcome|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
534581|NCT00816023|O1|Outcome|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
534582|NCT00816023|O4|Outcome|Placebo|
534583|NCT00816023|O3|Outcome|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
534584|NCT00816023|O2|Outcome|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
534585|NCT00816023|O1|Outcome|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
534586|NCT00816023|E4|Reported Event|PLACEBO|
534587|NCT00816023|E3|Reported Event|ECALLANTIDE LOW DOSE|Target steady state concentration of 0.15 mg/L
534588|NCT00816023|E2|Reported Event|ECALLANTIDE MEDIUM DOSE|Target steady state concentration of 0.75 mg/L
534589|NCT00816023|E1|Reported Event|ECALLANTIDE HIGH DOSE|Target steady state concentration of 2.25 mg/L
534590|NCT00816036|B3|Baseline|Total|Total of all reporting groups
534591|NCT00816036|B2|Baseline|Arm 2|"Intervention Period
Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
534592|NCT00816036|B1|Baseline|Arm 1|Pre-intervention Period
534593|NCT00816036|P2|Participant Flow|Intervention Period|"Intervention Period
Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
534594|NCT00816036|P1|Participant Flow|Pre-intervention Period|Pre-intervention Period
534595|NCT00816036|O2|Outcome|Arm 2|"Intervention Period
Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
534596|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
534597|NCT00816036|O2|Outcome|Arm 2|"Intervention Period
Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
534598|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
534627|NCT00816166|O2|Outcome|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)
Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
534599|NCT00816036|O2|Outcome|Arm 2|"Intervention Period
Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
534600|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
534601|NCT00816036|E2|Reported Event|Arm 2|"Intervention Period
Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
534602|NCT00816036|E1|Reported Event|Arm 1|Pre-intervention Period
534603|NCT00816101|B4|Baseline|Total|Total of all reporting groups
534604|NCT00816101|B3|Baseline|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
534605|NCT00816101|B2|Baseline|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
534606|NCT00816101|B1|Baseline|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.
Dressing changes every 3 days, more frequently if needed"
534607|NCT00816101|P3|Participant Flow|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
534608|NCT00816101|P2|Participant Flow|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
534609|NCT00816101|P1|Participant Flow|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.
Dressing changes every 3 days, more frequently if needed"
534610|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
534611|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
534612|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.
Dressing changes every 3 days, more frequently if needed"
534613|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
534614|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
534615|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.
Dressing changes every 3 days, more frequently if needed"
534616|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
534617|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
534618|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.
Dressing changes every 3 days, more frequently if needed"
534619|NCT00816101|E3|Reported Event|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
534620|NCT00816101|E2|Reported Event|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
534621|NCT00816101|E1|Reported Event|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.
Dressing changes every 3 days, more frequently if needed"
534622|NCT00816166|B3|Baseline|Total|Total of all reporting groups
534623|NCT00816166|B2|Baseline|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)
Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
534624|NCT00816166|B1|Baseline|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)
Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
534625|NCT00816166|P2|Participant Flow|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)
Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
534626|NCT00816166|P1|Participant Flow|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)
Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
534840|NCT00816556|P3|Participant Flow|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534628|NCT00816166|O1|Outcome|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)
Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
534629|NCT00816166|E2|Reported Event|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)
Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
534630|NCT00816166|E1|Reported Event|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)
Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
534631|NCT00816348|B1|Baseline|Omegaven|"All subjects will receive Omegaven
Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
534632|NCT00816348|P1|Participant Flow|Omegaven|"All subjects will receive Omegaven
Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
534633|NCT00816348|O1|Outcome|Omegaven|"All subjects will receive Omegaven
Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
534634|NCT00816348|E1|Reported Event|Omegaven|"All subjects will receive Omegaven
Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
534635|NCT00816400|B10|Baseline|Total|Total of all reporting groups
534636|NCT00816400|B9|Baseline|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534637|NCT00816400|B8|Baseline|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534638|NCT00816400|B7|Baseline|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534639|NCT00816400|B6|Baseline|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534640|NCT00816400|B5|Baseline|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534641|NCT00816400|B4|Baseline|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534642|NCT00816400|B3|Baseline|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534643|NCT00816400|B2|Baseline|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534644|NCT00816400|B1|Baseline|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534645|NCT00816400|P9|Participant Flow|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534845|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534646|NCT00816400|P8|Participant Flow|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534647|NCT00816400|P7|Participant Flow|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534648|NCT00816400|P6|Participant Flow|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534649|NCT00816400|P5|Participant Flow|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534650|NCT00816400|P4|Participant Flow|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534651|NCT00816400|P3|Participant Flow|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534652|NCT00816400|P2|Participant Flow|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534653|NCT00816400|P1|Participant Flow|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534654|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534655|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534656|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534657|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534658|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534659|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534660|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534661|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534662|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534663|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534664|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534665|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534666|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534841|NCT00816556|P2|Participant Flow|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534667|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534668|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534669|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534670|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534671|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534672|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534673|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534674|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534675|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534676|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534677|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534678|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534679|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534680|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534681|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534682|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534683|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534684|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534685|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534686|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534687|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534842|NCT00816556|P1|Participant Flow|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534913|NCT00816907|O2|Outcome|Metformin|
534688|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534689|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534690|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534691|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534692|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534693|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534694|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534695|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534696|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534697|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534698|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534699|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534700|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534701|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534702|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534703|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534704|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534705|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534706|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534707|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534708|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534914|NCT00816907|O1|Outcome|Placebo|
534915|NCT00816907|O2|Outcome|Metformin|
534709|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534710|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534711|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534712|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534713|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534714|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534715|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534716|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534717|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534718|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534719|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
534720|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534721|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534722|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534723|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534724|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534725|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534726|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534727|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534728|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534729|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
534730|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534916|NCT00816907|O1|Outcome|Placebo|
534917|NCT00816907|O2|Outcome|Metformin|
534731|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534732|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534733|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534734|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534735|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534736|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534737|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534738|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534739|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
534740|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534741|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534742|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534743|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534744|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534745|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534746|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534747|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534748|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534749|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
534750|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534751|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534752|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534918|NCT00816907|O1|Outcome|Placebo|
534919|NCT00816907|O2|Outcome|Metformin|
534753|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534754|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534755|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534756|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534757|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534758|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534759|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
534760|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534761|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534762|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534763|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534764|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534765|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534766|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534767|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534768|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534769|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
534770|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534771|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534772|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534773|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534774|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534920|NCT00816907|O1|Outcome|Placebo|
534921|NCT00816907|O2|Outcome|Metformin|
534775|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534776|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534777|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534778|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534779|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534780|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534781|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534782|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534783|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534784|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534785|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534786|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534787|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534788|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534789|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534790|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534791|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534792|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534793|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534794|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534795|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534922|NCT00816907|O1|Outcome|Placebo|
534796|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534797|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534798|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534799|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534800|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534801|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534802|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534803|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534804|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534805|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534806|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534807|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534808|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534809|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534810|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534811|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534812|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534813|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534814|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534815|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534816|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534843|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
543867|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
534817|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534818|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534819|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534820|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534821|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534822|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534823|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534824|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534825|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534826|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534827|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534828|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534829|NCT00816400|E7|Reported Event|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534830|NCT00816400|E6|Reported Event|MEDI-575, 25 mg/kg Q3Wk Escalation/Expansion Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534831|NCT00816400|E5|Reported Event|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534832|NCT00816400|E4|Reported Event|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534833|NCT00816400|E3|Reported Event|MEDI-575, 9.0 mg/kg QWk Escalation/Expansion Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21 day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534834|NCT00816400|E2|Reported Event|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534835|NCT00816400|E1|Reported Event|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
534836|NCT00816556|B4|Baseline|Total|Total of all reporting groups
534837|NCT00816556|B3|Baseline|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534838|NCT00816556|B2|Baseline|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534839|NCT00816556|B1|Baseline|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534846|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534847|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534848|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534849|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534850|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534851|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534852|NCT00816556|E3|Reported Event|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534853|NCT00816556|E2|Reported Event|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534854|NCT00816556|E1|Reported Event|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
534855|NCT00816595|B3|Baseline|Total|Total of all reporting groups
534856|NCT00816595|B2|Baseline|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
534857|NCT00816595|B1|Baseline|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
534858|NCT00816595|P2|Participant Flow|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
534859|NCT00816595|P1|Participant Flow|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
534860|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
534861|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
534862|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
534863|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
534864|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
534923|NCT00816907|O2|Outcome|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
534924|NCT00816907|O1|Outcome|Placebo|Matching over-encapsulated placebo pills
534865|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
534866|NCT00816595|E2|Reported Event|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
534867|NCT00816595|E1|Reported Event|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
534868|NCT00816777|B3|Baseline|Total|Total of all reporting groups
534869|NCT00816777|B2|Baseline|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks
Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
534870|NCT00816777|B1|Baseline|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)
Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule
Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
534871|NCT00816777|P2|Participant Flow|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks
Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
534872|NCT00816777|P1|Participant Flow|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)
Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule
Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
534873|NCT00816777|O2|Outcome|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks
Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
534874|NCT00816777|O1|Outcome|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)
Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule
Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
534875|NCT00816777|E2|Reported Event|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks
Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
534876|NCT00816777|E1|Reported Event|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)
Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule
Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
534877|NCT00816829|B3|Baseline|Total|Total of all reporting groups
534878|NCT00816829|B2|Baseline|Fenofibrate|Fenofibrate 145 mg
534879|NCT00816829|B1|Baseline|Placebo|Placebo
534880|NCT00816829|P2|Participant Flow|Fenofibrate|Fenofibrate 145 mg
534881|NCT00816829|P1|Participant Flow|Placebo|Placebo
534882|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
534883|NCT00816829|O1|Outcome|Placebo|Placebo
534884|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
534885|NCT00816829|O1|Outcome|Placebo|Placebo
534886|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
534887|NCT00816829|O1|Outcome|Placebo|Placebo
534888|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
534889|NCT00816829|O1|Outcome|Placebo|Placebo
534890|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
534891|NCT00816829|O1|Outcome|Placebo|Placebo
534892|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
534893|NCT00816829|O1|Outcome|Placebo|Placebo
534894|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
534895|NCT00816829|O1|Outcome|Placebo|Placebo
534896|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
534897|NCT00816829|O1|Outcome|Placebo|Placebo
534898|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
534899|NCT00816829|O1|Outcome|Placebo|Placebo
534900|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
534901|NCT00816829|O1|Outcome|Placebo|Placebo
534902|NCT00816829|E2|Reported Event|Fenofibrate|Fenofibrate 145 mg
534903|NCT00816829|E1|Reported Event|Placebo|Placebo
534904|NCT00816907|B3|Baseline|Total|Total of all reporting groups
534905|NCT00816907|B2|Baseline|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
534906|NCT00816907|B1|Baseline|Placebo|Matching over-encapsulated placebo pills
534907|NCT00816907|P2|Participant Flow|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
534908|NCT00816907|P1|Participant Flow|Placebo|Matching over-encapsulated placebo pills
534909|NCT00816907|O2|Outcome|Metformin|
534910|NCT00816907|O1|Outcome|Placebo|
534911|NCT00816907|O2|Outcome|Metformin|
534912|NCT00816907|O1|Outcome|Placebo|
534925|NCT00816907|E2|Reported Event|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
534926|NCT00816907|E1|Reported Event|Placebo|Matching over-encapsulated placebo pills
534927|NCT00817206|B3|Baseline|Total|Total of all reporting groups
534928|NCT00817206|B2|Baseline|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
534929|NCT00817206|B1|Baseline|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)
LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
534930|NCT00817206|P2|Participant Flow|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
534931|NCT00817206|P1|Participant Flow|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)
LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
534932|NCT00817206|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
534933|NCT00817206|O1|Outcome|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)
LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
534934|NCT00817206|E2|Reported Event|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
534935|NCT00817206|E1|Reported Event|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)
LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
534936|NCT00817219|B1|Baseline|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534937|NCT00817219|P1|Participant Flow|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534938|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534939|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534940|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534941|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534942|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534943|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534944|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534945|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534946|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534947|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534948|NCT00817219|E1|Reported Event|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
534949|NCT00817336|B3|Baseline|Total|Total of all reporting groups
534950|NCT00817336|B2|Baseline|Placebo Followed by D-serine|Does not include 1 drop-out during phase 1
534951|NCT00817336|B1|Baseline|D-serine Followed by Placebo|Does not include 1 drop-out during phase 1
534952|NCT00817336|P2|Participant Flow|Placebo Followed by D-serine|subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
534953|NCT00817336|P1|Participant Flow|D-serine Followed by Placebo|subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
534954|NCT00817336|O2|Outcome|Placebo|Placebo: oral
534955|NCT00817336|O1|Outcome|D-serine|"60 mg/kg/day
D Serine: 60 mg/kg/day"
534956|NCT00817336|O2|Outcome|Placebo|Placebo: oral
534957|NCT00817336|O1|Outcome|D-serine|"60 mg/kg/day
D Serine: 60 mg/kg/day"
534958|NCT00817336|O2|Outcome|Placebo|Placebo: oral
534959|NCT00817336|O1|Outcome|D-serine|"60 mg/kg/day
D Serine: 60 mg/kg/day"
534962|NCT00817336|E1|Reported Event|D-serine/Placebo Crossover|subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
534963|NCT00817479|B3|Baseline|Total|Total of all reporting groups
534964|NCT00817479|B2|Baseline|Dexamethasone|20 mg dexamethasone IV push
534965|NCT00817479|B1|Baseline|Placebo|Placebo [saline]
534966|NCT00817479|P2|Participant Flow|Dexamethasone|20 mg dexamethasone IV push
534967|NCT00817479|P1|Participant Flow|Placebo|Placebo [saline]
534968|NCT00817479|O2|Outcome|Dexamethasone|20 mg dexamethasone IV push
534969|NCT00817479|O1|Outcome|Placebo|Placebo [saline]
534970|NCT00817479|O2|Outcome|Dexamethasone|20 mg dexamethasone IV push
534971|NCT00817479|O1|Outcome|Placebo|Placebo [saline]
534972|NCT00817479|E2|Reported Event|Dexamethasone|20 mg dexamethasone IV push
534973|NCT00817479|E1|Reported Event|Placebo|Placebo [saline]
534974|NCT00817531|B1|Baseline|Dasatinib|Patients took Dasatinib 100mg daily
534975|NCT00817531|P1|Participant Flow|Dasatinib|Patients took Dasatinib 100mg daily
534976|NCT00817531|O1|Outcome|Dasatinib|Dasatinib 100 mg once daily
534977|NCT00817531|E1|Reported Event|Dasatinib|Patients took Dasatinib 100mg daily
534978|NCT00810511|B3|Baseline|Total|Total of all reporting groups
534979|NCT00810511|B2|Baseline|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
534980|NCT00810511|B1|Baseline|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
534981|NCT00810511|P2|Participant Flow|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
534982|NCT00810511|P1|Participant Flow|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
534983|NCT00810511|O2|Outcome|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
534984|NCT00810511|O1|Outcome|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
534985|NCT00810511|E2|Reported Event|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
534986|NCT00810511|E1|Reported Event|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
534987|NCT00810576|B1|Baseline|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
534988|NCT00810576|P1|Participant Flow|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
534989|NCT00810576|O1|Outcome|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
534990|NCT00810576|E1|Reported Event|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
534991|NCT00810602|B1|Baseline|Vorinostat Prophylaxis|"Vorinostat, combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.
Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.
Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
534992|NCT00810602|P2|Participant Flow|Phase 2|100 mg was selected as the Phase 2 dose. Participants were administered Vorinostat, 100 mg, twice daily, orally, starting ten days prior to the stem cell infusion and continuing through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
534993|NCT00810602|P1|Participant Flow|Phase 1|In the Phase 1 portion of the study, participants were administered Vorinostat, either 100 mg or 200mg, twice daily, orally, starting ten days prior to the stem cell infusion and continuing through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
534994|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.
Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.
Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
534995|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.
Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.
Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
535026|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
543868|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
534996|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.
Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.
Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
534997|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.
Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.
Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
534998|NCT00810602|E1|Reported Event|Vorinostat Prophylaxis|"Vorinostat, combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.
Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.
Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
534999|NCT00810641|B4|Baseline|Total|Total of all reporting groups
535000|NCT00810641|B3|Baseline|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
535001|NCT00810641|B2|Baseline|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
535002|NCT00810641|B1|Baseline|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
535003|NCT00810641|P3|Participant Flow|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
535004|NCT00810641|P2|Participant Flow|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
535005|NCT00810641|P1|Participant Flow|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
535006|NCT00810641|O3|Outcome|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
535007|NCT00810641|O2|Outcome|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
535008|NCT00810641|O1|Outcome|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
535009|NCT00810641|E3|Reported Event|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
535010|NCT00810641|E2|Reported Event|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
535011|NCT00810641|E1|Reported Event|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
535012|NCT00810693|B4|Baseline|Total|Total of all reporting groups
535013|NCT00810693|B3|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
535014|NCT00810693|B2|Baseline|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535015|NCT00810693|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535016|NCT00810693|P3|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
535017|NCT00810693|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535018|NCT00810693|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535019|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
535020|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535021|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535022|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
535023|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535024|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535025|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
535212|NCT00811252|B3|Baseline|Duloxetine 60 mg|encapsulated tablets; daily; orally
535027|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535028|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
535029|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535030|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535031|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
535032|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535033|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535034|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
535035|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535036|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535037|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
535038|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535039|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535040|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
535041|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535042|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535043|NCT00810693|E3|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
535044|NCT00810693|E2|Reported Event|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535045|NCT00810693|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
535046|NCT00810719|B1|Baseline|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.
Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.
gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
535047|NCT00810719|P1|Participant Flow|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.
Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.
gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
535048|NCT00810719|O1|Outcome|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.
Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.
gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
535085|NCT00810901|O1|Outcome|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol
Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
535049|NCT00810719|O1|Outcome|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.
Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.
gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
535050|NCT00810719|O1|Outcome|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.
Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.
gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
535051|NCT00810719|E1|Reported Event|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.
Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.
gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
535052|NCT00810771|B4|Baseline|Total|Total of all reporting groups
535053|NCT00810771|B3|Baseline|Usual Care|Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
535054|NCT00810771|B2|Baseline|Standard Information (SI) Intervention|Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
535055|NCT00810771|B1|Baseline|Preference-tailored (PT) Intervention|Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
535056|NCT00810771|P3|Participant Flow|Usual Care|Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
535057|NCT00810771|P2|Participant Flow|Standard Information (SI) Intervention|Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
535058|NCT00810771|P1|Participant Flow|Preference-tailored (PT) Intervention|"Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
535059|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention
Behavioral: Standard Information"
535060|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information"
535061|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention
Behavioral: Standard Information"
535062|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information"
535063|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention
Behavioral: Standard Information
Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
535086|NCT00810901|E2|Reported Event|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.
Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
535213|NCT00811252|B2|Baseline|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535214|NCT00811252|B1|Baseline|Placebo|capsules; daily; orally
535064|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information
Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
535065|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention
Behavioral: Standard Information"
535066|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information"
535067|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention
Behavioral: Standard Information"
535068|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information"
535069|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention
Behavioral: Standard Information
Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
535070|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information
Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
535071|NCT00810771|O3|Outcome|Usual Care|"Usual Care - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening."
535072|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention
Behavioral: Standard Information
Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
535073|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information
Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
535074|NCT00810771|E3|Reported Event|Usual Care|"Usual Care - due to budget and time constraints this group was not powered as a true study arm but was used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may occur during the study timeframe and impact rated of CRC screening. Data was not collected on every participant in this arm."
535075|NCT00810771|E2|Reported Event|Standard Information (SI) Intervention|Standard information (SI) intervention
535076|NCT00810771|E1|Reported Event|Preference-tailored (PT) Intervention|Preference-tailored (PT) intervention
535077|NCT00810901|B3|Baseline|Total|Total of all reporting groups
535078|NCT00810901|B2|Baseline|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol
Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
535079|NCT00810901|B1|Baseline|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.
Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
535080|NCT00810901|P2|Participant Flow|Alcohol Prevention|"Intervention used a digital video disk (DVD) and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol
Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
535081|NCT00810901|P1|Participant Flow|Organ Donor|"Intervention used a digital video disk (DVD), text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.
Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
535082|NCT00810901|O2|Outcome|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.
Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
535083|NCT00810901|O1|Outcome|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol
Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
535084|NCT00810901|O2|Outcome|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.
Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
535087|NCT00810901|E1|Reported Event|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol
Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
535088|NCT00811018|B1|Baseline|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535089|NCT00811018|P1|Participant Flow|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535090|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535091|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535092|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535093|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535094|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535095|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535096|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535097|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535098|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535099|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535100|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535101|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535102|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535103|NCT00811018|E1|Reported Event|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
535104|NCT00811057|B4|Baseline|Total|Total of all reporting groups
535105|NCT00811057|B3|Baseline|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
535106|NCT00811057|B2|Baseline|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.
Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
535107|NCT00811057|B1|Baseline|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
535108|NCT00811057|P3|Participant Flow|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
535109|NCT00811057|P2|Participant Flow|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.
Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
535110|NCT00811057|P1|Participant Flow|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
535111|NCT00811057|O3|Outcome|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
535112|NCT00811057|O2|Outcome|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.
Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
535113|NCT00811057|O1|Outcome|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
535114|NCT00811057|O3|Outcome|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
535185|NCT00811070|E3|Reported Event|Total Population|Total participants who were second-line or third-line chronic myelogenous leukemia (CML).
535215|NCT00811252|P3|Participant Flow|Duloxetine 60 mg|encapsulated tablets; daily; orally
535115|NCT00811057|O2|Outcome|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.
Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
535116|NCT00811057|O1|Outcome|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
535117|NCT00811057|E3|Reported Event|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
535118|NCT00811057|E2|Reported Event|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.
Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
535119|NCT00811057|E1|Reported Event|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
535120|NCT00811070|B7|Baseline|Total|Total of all reporting groups
535121|NCT00811070|B6|Baseline|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535122|NCT00811070|B5|Baseline|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535123|NCT00811070|B4|Baseline|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535124|NCT00811070|B3|Baseline|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
535125|NCT00811070|B2|Baseline|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535126|NCT00811070|B1|Baseline|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535127|NCT00811070|P6|Participant Flow|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535128|NCT00811070|P5|Participant Flow|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535129|NCT00811070|P4|Participant Flow|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535130|NCT00811070|P3|Participant Flow|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
535131|NCT00811070|P2|Participant Flow|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535132|NCT00811070|P1|Participant Flow|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535133|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535134|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535135|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535136|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535137|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535138|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535139|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535140|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535141|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535142|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535143|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535144|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535145|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535146|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535147|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535148|NCT00811070|O2|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535149|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535150|NCT00811070|O2|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535151|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535152|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535186|NCT00811070|E2|Reported Event|Exploratory Third-line|All participants who received bosutinib 500 mg orally once daily in third-line chronic myelogenous leukemia (CML), participants were with imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant.
543869|NCT00832416|O4|Outcome|4: Placebo|
535153|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
535154|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535155|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535156|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535157|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535158|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535159|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
535160|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
535161|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535162|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535163|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
535164|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535165|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535166|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
535167|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535168|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535187|NCT00811070|E1|Reported Event|Total Second-line|All participants who received bosutinib orally once daily in second-line chronic myelogenous leukemia (CML), who were imatinib resistant/refractory/intolerant.
535169|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
535170|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535171|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535172|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
535173|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535174|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535175|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
535176|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535177|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535178|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
535179|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535180|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535181|NCT00811070|O1|Outcome|All Treated Participants (Part 1 )|All participants who received single oral dose of bosutinib 400 mg, 500 mg or 600 mg on Day 1 and then bosutinib 400 mg, 500 mg or 600 mg orally once daily continuously from Day 3 up to Week 4.
535182|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
535183|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535184|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
535188|NCT00811135|B1|Baseline|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535189|NCT00811135|P1|Participant Flow|Trastuzumab + Bevacizumab + Capecitabine|Participants received intravenous (IV) trastuzumab (8 milligrams per kilogram [mg/kg]) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 milligrams per meter square (mg/m^2) twice daily (BID) on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535190|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535191|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535192|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535193|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535194|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535195|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535196|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535197|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535198|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535199|NCT00811135|E1|Reported Event|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
535200|NCT00811174|B1|Baseline|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
535201|NCT00811174|P1|Participant Flow|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
535202|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
535203|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
535204|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
535205|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
535206|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
535207|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
535208|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
535209|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
535210|NCT00811174|E1|Reported Event|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
535216|NCT00811252|P2|Participant Flow|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535217|NCT00811252|P1|Participant Flow|Placebo|capsules; daily; orally
535218|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535219|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535220|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535221|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535222|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535223|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535224|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535225|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535226|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535227|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535228|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535229|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535230|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535231|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535232|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535233|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535234|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535235|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535236|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535237|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535238|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535239|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535240|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535241|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535242|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535243|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535244|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535245|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535246|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535247|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535248|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535249|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535250|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535251|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535252|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535253|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535254|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
535255|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
535256|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
535257|NCT00811252|E3|Reported Event|Duloxetine 60 mg|
535258|NCT00811252|E2|Reported Event|Vortioxetine 5 mg|
535259|NCT00811252|E1|Reported Event|Placebo|
535260|NCT00811382|B3|Baseline|Total|Total of all reporting groups
535261|NCT00811382|B2|Baseline|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)."
535262|NCT00811382|B1|Baseline|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC.
Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring."
535263|NCT00811382|P2|Participant Flow|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
535264|NCT00811382|P1|Participant Flow|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC
Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
535265|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
535266|NCT00811382|O1|Outcome|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC
Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
535267|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
535303|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535268|NCT00811382|O1|Outcome|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC
Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
535269|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
535270|NCT00811382|O1|Outcome|1: Access to HMSC (Home Monitoring Service Center)|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
535271|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
535272|NCT00811382|O1|Outcome|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC
Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
535273|NCT00811382|E2|Reported Event|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
535274|NCT00811382|E1|Reported Event|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of cardiac resynchronization therapy and management of atrial fibrillation with a full access for the treating physician to the Home Monitoring Service Center
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy with Home Monitoring feature): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
535275|NCT00811395|B7|Baseline|Total|Total of all reporting groups
535276|NCT00811395|B6|Baseline|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
535277|NCT00811395|B5|Baseline|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
535278|NCT00811395|B4|Baseline|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
535279|NCT00811395|B3|Baseline|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535280|NCT00811395|B2|Baseline|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535281|NCT00811395|B1|Baseline|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535282|NCT00811395|P6|Participant Flow|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
535283|NCT00811395|P5|Participant Flow|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
535284|NCT00811395|P4|Participant Flow|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
535285|NCT00811395|P3|Participant Flow|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535286|NCT00811395|P2|Participant Flow|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535287|NCT00811395|P1|Participant Flow|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535288|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
535289|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
535290|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
535291|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535292|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535293|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535294|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
535295|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
535296|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
535297|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535298|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535299|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535300|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
535301|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
535302|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
535357|NCT00811473|B3|Baseline|Total|Total of all reporting groups
535304|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535305|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535306|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
535307|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
535308|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
535309|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535310|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535311|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535312|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
535313|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
535314|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
535315|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535316|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535317|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535318|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
535319|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
535320|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
535321|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535322|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535323|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535324|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
535325|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
535326|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
535327|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535328|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535329|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535330|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA]
535331|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA]
535332|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA]
535333|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535334|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535335|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535336|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
535337|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
535338|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
535339|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535340|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535341|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535342|NCT00811395|E6|Reported Event|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA]
535343|NCT00811395|E5|Reported Event|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA]
535344|NCT00811395|E4|Reported Event|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA]
535345|NCT00811395|E3|Reported Event|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
535346|NCT00811395|E2|Reported Event|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
535347|NCT00811395|E1|Reported Event|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
535348|NCT00811434|B1|Baseline|All Participants|all aprticipants who were randomized to receive treatment
535349|NCT00811434|P2|Participant Flow|Placebo First, Then Lactulose|Placebo therapy of 1.5ml/kg/day; washout; lactulose therapy based on weight
535350|NCT00811434|P1|Participant Flow|Lactulose First, Then Placebo|Lactulose therapy based on weight; Washout; placebo therapy of 1.5ml/kg/day
535351|NCT00811434|O2|Outcome|Placebo|1.5 ml/kg day po of sugar water placebo for three months
535352|NCT00811434|O1|Outcome|Lactulose|3 months of Lactulose therapy based on pt. weight
535353|NCT00811434|O1|Outcome|All Randomized Participants|
535354|NCT00811434|O1|Outcome|All Randomized Participants|
535355|NCT00811434|E2|Reported Event|Placebo|1.5 ml/kg day po of sugar water placebo for three months
535356|NCT00811434|E1|Reported Event|Lactulose|3 months of Lactulose therapy based on pt. weight
535359|NCT00811473|B1|Baseline|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
535360|NCT00811473|P2|Participant Flow|Placebo|Matching placebo
535361|NCT00811473|P1|Participant Flow|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
535362|NCT00811473|O2|Outcome|Placebo|Matching placebo
535363|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
535364|NCT00811473|O2|Outcome|Placebo|Matching placebo
535365|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
535366|NCT00811473|O2|Outcome|Placebo|Matching placebo
535367|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
535368|NCT00811473|O2|Outcome|Placebo|Matching placebo
535369|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
535370|NCT00811473|O2|Outcome|Placebo|Matching placebo
535371|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
535372|NCT00811473|O2|Outcome|Placebo|Matching placebo
535373|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
535374|NCT00811473|E2|Reported Event|Placebo|Matching placebo
535375|NCT00811473|E1|Reported Event|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
535376|NCT00811564|B3|Baseline|Total|Total of all reporting groups
535377|NCT00811564|B2|Baseline|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
535378|NCT00811564|B1|Baseline|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
535379|NCT00811564|P2|Participant Flow|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
535380|NCT00811564|P1|Participant Flow|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
535381|NCT00811564|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
535382|NCT00811564|O1|Outcome|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
535383|NCT00811564|E2|Reported Event|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
535384|NCT00811564|E1|Reported Event|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
535385|NCT00811577|B3|Baseline|Total|Total of all reporting groups
535386|NCT00811577|B2|Baseline|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
535387|NCT00811577|B1|Baseline|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
535388|NCT00811577|P2|Participant Flow|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
535389|NCT00811577|P1|Participant Flow|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
535390|NCT00811577|O3|Outcome|Alpha SMA Results for 10 mg AZX100 Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535391|NCT00811577|O2|Outcome|Alpha SMA Results for 3 mg AZX100 Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535392|NCT00811577|O1|Outcome|Alpha SMA Results for Placebo Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535393|NCT00811577|O9|Outcome|Collagen Fiber Orientation Results for 10 mg AZX100 Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535394|NCT00811577|O8|Outcome|Collagen Fiber Orientation Results for 3 mg AZX100 Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535395|NCT00811577|O7|Outcome|Collagen Fiber Orientation Results for Placebo Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535396|NCT00811577|O6|Outcome|Collagen Fiber Maturity Results for 10 mg AZX100 Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535397|NCT00811577|O5|Outcome|Collagen Fiber Maturity Results for 3 mg AZX100 Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535398|NCT00811577|O4|Outcome|Collagen Fiber Maturity Results for Placebo Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535399|NCT00811577|O3|Outcome|Collagen Fiber Density Results for 10 mg AZX100 Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535400|NCT00811577|O2|Outcome|Collagen Fiber Density Results for 3 mg AZX100 Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535401|NCT00811577|O1|Outcome|Collagen Fiber Density Results for Placebo Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535402|NCT00811577|O9|Outcome|Scar Total Volume for 10 mg AZX100 Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535403|NCT00811577|O8|Outcome|Scar Total Volume for 3 mg AZX100 Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535404|NCT00811577|O7|Outcome|Scar Total Volume for Placebo Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535405|NCT00811577|O6|Outcome|Scar Negative Volume for 10 mg AZX100 Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535406|NCT00811577|O5|Outcome|Scar Negative Volume for 3 mg AZX100 Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535407|NCT00811577|O4|Outcome|Scar Negative Volume for Placebo Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535408|NCT00811577|O3|Outcome|Scar Positive Volume for 10 mg AZX100 Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535409|NCT00811577|O2|Outcome|Scar Positive Volume for 3 mg AZX100 Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535410|NCT00811577|O1|Outcome|Scar Positive Volume for Placebo Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535411|NCT00811577|O12|Outcome|Scar Maximum Elevation for 10 mg AZX100 Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535412|NCT00811577|O11|Outcome|Scar Maximum Elevation for 3 mg AZX100 Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535413|NCT00811577|O10|Outcome|Scar Maximum Elevation for Placebo Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535414|NCT00811577|O9|Outcome|Scar Minimum Elevation for 10 mg AZX100 Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535415|NCT00811577|O8|Outcome|Scar Minimum Elevation for 3 mg AZX100 Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535416|NCT00811577|O7|Outcome|Scar Minimum Elevation for Placebo Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 saline placebo/cm at 9 days and 21 days following shoulder surgery.
535417|NCT00811577|O6|Outcome|Scar Width for 10 mg AZX100 Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535418|NCT00811577|O5|Outcome|Scar Width for 3 mg AZX100 Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535419|NCT00811577|O4|Outcome|Scar Width for Placebo Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535420|NCT00811577|O3|Outcome|Scar Length for 10 mg AZX100 Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535421|NCT00811577|O2|Outcome|Scar Length for 3 mg AZX100 Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535422|NCT00811577|O1|Outcome|Scar Length for Placebo Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535423|NCT00811577|O6|Outcome|Rater 2 VAS Scores for 10 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535424|NCT00811577|O5|Outcome|Rater 2 VAS Scores for 3 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535425|NCT00811577|O4|Outcome|Rater 2 VAS Scores for Placebo Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535426|NCT00811577|O3|Outcome|Rater 1 VAS Scores for 10 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535427|NCT00811577|O2|Outcome|Rater 1 VAS Scores for 3 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535428|NCT00811577|O1|Outcome|Rater 1 VAS Scores for Placebo Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535429|NCT00811577|O6|Outcome|OSAS Results for 10 mg AZX100 Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535589|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
535430|NCT00811577|O5|Outcome|OSAS Results for 3 mg AZX100 Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535431|NCT00811577|O4|Outcome|OSAS Results for Placebo Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535432|NCT00811577|O3|Outcome|PSAS Results for 10 mg AZX100 Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
535433|NCT00811577|O2|Outcome|PSAS Results for 3 mg AZX100 Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
535434|NCT00811577|O1|Outcome|PSAS Results for Placebo Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
535435|NCT00811577|E2|Reported Event|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
535436|NCT00811577|E1|Reported Event|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
535437|NCT00811590|B1|Baseline|All Patients|All patients enrolled/eligible.
535438|NCT00811590|P1|Participant Flow|All Patients|All patients enrolled/eligible.
535439|NCT00811590|O1|Outcome|All Patients|All enrolled/eligible patients.
535440|NCT00811590|E1|Reported Event|All Patients|All enrolled/eligible patients.
535441|NCT00811642|B1|Baseline|Posaconazole|"400 mg twice a day (BID) oral suspension for
12 weeks"
535442|NCT00811642|P1|Participant Flow|Posaconazole|"400 mg twice a day (BID) oral suspension for
12 weeks"
535443|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for
12 weeks"
535444|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for
12 weeks"
535445|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for
12 weeks"
535446|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for
12 weeks"
535447|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for
12 weeks"
535448|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for
12 weeks"
535449|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for
12 weeks"
535450|NCT00811642|E1|Reported Event|POSACONAZOLE|400mg oral suspension BID for 12 weeks
535451|NCT00817596|B1|Baseline|Prometra Intrathecal Pump System|This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.
535452|NCT00817596|P1|Participant Flow|Prometra Intrathecal Pump System|This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.
535453|NCT00817596|O1|Outcome|Group 1|Prometra Intrathecal Pump System
535454|NCT00817596|E1|Reported Event|Group 1|Prometra Intrathecal Pump System
535455|NCT00817778|B3|Baseline|Total|Total of all reporting groups
535456|NCT00817778|B2|Baseline|Placebo Comparator|Placebo
535457|NCT00817778|B1|Baseline|Experimental|AZD1656
535458|NCT00817778|P2|Participant Flow|Placebo Comparator|Placebo
535459|NCT00817778|P1|Participant Flow|Experimental|AZD1656
535460|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
535461|NCT00817778|O1|Outcome|Experimental|AZD1656
535462|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
535463|NCT00817778|O1|Outcome|Experimental|AZD1656
535464|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
535465|NCT00817778|O1|Outcome|Experimental|AZD1656
535466|NCT00817778|O1|Outcome|Experimental|AZD1656
535467|NCT00817778|O1|Outcome|Experimental|AZD1656
535468|NCT00817778|O1|Outcome|Experimental|AZD1656
535469|NCT00817778|O1|Outcome|Experimental|AZD1656
535470|NCT00817778|O1|Outcome|Experimental|AZD1656
535471|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
535472|NCT00817778|O1|Outcome|Experimental|AZD1656
535473|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
535474|NCT00817778|O1|Outcome|Experimental|AZD1656
535475|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
535476|NCT00817778|O1|Outcome|Experimental|AZD1656
535477|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
535478|NCT00817778|O1|Outcome|Experimental|AZD1656
535479|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
535480|NCT00817778|O1|Outcome|Experimental|AZD1656
535481|NCT00817778|E2|Reported Event|Placebo Comparator|Placebo
535482|NCT00817778|E1|Reported Event|Experimental|AZD1656
535483|NCT00817804|B3|Baseline|Total|Total of all reporting groups
535484|NCT00817804|B2|Baseline|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
535485|NCT00817804|B1|Baseline|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
535486|NCT00817804|P2|Participant Flow|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
535487|NCT00817804|P1|Participant Flow|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
535488|NCT00817804|O2|Outcome|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
535489|NCT00817804|O1|Outcome|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
535490|NCT00817804|E2|Reported Event|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
535491|NCT00817804|E1|Reported Event|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
535590|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
535492|NCT00817843|B1|Baseline|Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg|All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
535493|NCT00817843|P2|Participant Flow|Simvastatin/Ezetimibe 10/10mg First, Then Simvastatin 80mg|First 6 weeks of treatment with simvastatin/ezetimibe 10/10 mg combination with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin 80 mg and placebo
535494|NCT00817843|P1|Participant Flow|Simvastatin 80mg First, Then Simvastatin/Ezetimibe 10/10mg|First 6 weeks of treatment with simvastatin 80 mg with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin/ezetimibe 10/10 mg combination and placebo
535495|NCT00817843|O2|Outcome|Simvastatin 10 mg / Ezetimibe 10 mg|6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg
535496|NCT00817843|O1|Outcome|Simvastatin 80 mg|6 weeks of treatment with simvastatin 80 mg
535497|NCT00817843|E1|Reported Event|Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg|All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
535498|NCT00818519|B3|Baseline|Total|Total of all reporting groups
535499|NCT00818519|B2|Baseline|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535500|NCT00818519|B1|Baseline|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535501|NCT00818519|P2|Participant Flow|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535502|NCT00818519|P1|Participant Flow|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535503|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535504|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535505|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535506|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535507|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535508|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535509|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535510|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535511|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535512|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535513|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535514|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535515|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535516|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535517|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535518|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535519|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535520|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535521|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535522|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535523|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535524|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535525|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535526|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535527|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535528|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535529|NCT00818519|E2|Reported Event|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
535530|NCT00818519|E1|Reported Event|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
535531|NCT00818623|B9|Baseline|Total|Total of all reporting groups
535532|NCT00818623|B8|Baseline|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
535533|NCT00818623|B7|Baseline|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
535534|NCT00818623|B6|Baseline|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
535535|NCT00818623|B5|Baseline|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
535536|NCT00818623|B4|Baseline|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
535537|NCT00818623|B3|Baseline|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
535538|NCT00818623|B2|Baseline|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
535539|NCT00818623|B1|Baseline|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
535540|NCT00818623|P8|Participant Flow|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
535541|NCT00818623|P7|Participant Flow|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
535542|NCT00818623|P6|Participant Flow|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
535543|NCT00818623|P5|Participant Flow|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
535544|NCT00818623|P4|Participant Flow|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
535545|NCT00818623|P3|Participant Flow|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
535546|NCT00818623|P2|Participant Flow|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
535547|NCT00818623|P1|Participant Flow|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
535548|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
535549|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
535550|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
535551|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
535552|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
535553|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
535554|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
535555|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
535556|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
535557|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
535558|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
535559|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
535560|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
535561|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
535562|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
535563|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
535564|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
535565|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
535566|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
535567|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
535568|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
535569|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
535570|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
535571|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
535572|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
535573|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
535574|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
535575|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
535576|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
535577|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
535578|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
535579|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
535580|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
535581|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
535582|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
535583|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
535584|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
535585|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
535586|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
535587|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
535588|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
535591|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
535592|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
535593|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
535594|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
535595|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
535596|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
535597|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
535598|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
535599|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
535600|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
535601|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
535602|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
535603|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
535604|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
535605|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
535606|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
535607|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
535608|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
535609|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
535610|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
535611|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
535612|NCT00818623|E8|Reported Event|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
535613|NCT00818623|E7|Reported Event|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
535614|NCT00818623|E6|Reported Event|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
535615|NCT00818623|E5|Reported Event|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
535616|NCT00818623|E4|Reported Event|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
535617|NCT00818623|E3|Reported Event|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
535618|NCT00818623|E2|Reported Event|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
535619|NCT00818623|E1|Reported Event|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
535620|NCT00818649|B1|Baseline|Velcade + Vorinostat|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.
vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle
bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
535621|NCT00818649|P1|Participant Flow|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.
vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle
bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
535622|NCT00818649|O1|Outcome|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.
vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle
bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
535623|NCT00818649|O1|Outcome|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.
vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle
bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
535624|NCT00818649|O1|Outcome|Evaluable Patients|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment continued for a total of 3 treatment cycles.
vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle
bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
535625|NCT00818649|E1|Reported Event|Velcade + Vorinostat|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.
vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle
bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
535626|NCT00818662|B5|Baseline|Total|Total of all reporting groups
535627|NCT00818662|B4|Baseline|Placebo 2 mL/kg|"0.25% human albumin solution infused at 2 mL/kg/2weeks
Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks"
535628|NCT00818662|B3|Baseline|Placebo 4 mL/kg|"0.25% human albumin solution infused at 4 mL/kg/2weeks
Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks"
535629|NCT00818662|B2|Baseline|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535630|NCT00818662|B1|Baseline|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535631|NCT00818662|P4|Participant Flow|Placebo 2 mL/kg|"0.25% human albumin solution infused at 2 mL/kg/2weeks
Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks"
535632|NCT00818662|P3|Participant Flow|Placebo 4 mL/kg|"0.25% human albumin solution infused at 4 mL/kg/2weeks
Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks"
535633|NCT00818662|P2|Participant Flow|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535634|NCT00818662|P1|Participant Flow|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535635|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535636|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535637|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535638|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535639|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535640|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535641|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535642|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535643|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535644|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535645|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535646|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535647|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535648|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535649|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535650|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535651|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535652|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535653|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535654|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535655|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535656|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535657|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535658|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535659|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535660|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535661|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535662|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535663|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535664|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535665|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535666|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535667|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535668|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535669|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535670|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535671|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535672|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535673|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535674|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535675|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535676|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535677|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535678|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535679|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535680|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535681|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535682|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535683|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535684|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535685|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535686|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535687|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535688|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535689|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535690|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535691|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535692|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535693|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535694|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535736|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
535695|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535696|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535697|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535698|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535699|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535700|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535701|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535702|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535703|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535704|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535705|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535706|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535707|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535708|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535709|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535710|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
535711|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
535712|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
535713|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535714|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535715|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535716|NCT00818662|E3|Reported Event|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution
Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535717|NCT00818662|E2|Reported Event|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535718|NCT00818662|E1|Reported Event|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks
Adverse Events That Occurred During or After Treatment"
535719|NCT00818753|B4|Baseline|Total|Total of all reporting groups
535720|NCT00818753|B3|Baseline|Heparin|Unfractionated heparin administered during intervention
535721|NCT00818753|B2|Baseline|Dabigatran 150mg Bis in Die (BID)|
535722|NCT00818753|B1|Baseline|Dabigatran 110mg Bis in Die (BID)|
535723|NCT00818753|P3|Participant Flow|Heparin|Unfractionated heparin administered during intervention
535724|NCT00818753|P2|Participant Flow|Dabigatran 150mg Bis in Die (BID)|
535725|NCT00818753|P1|Participant Flow|Dabigatran 110mg Bis in Die (BID)|
535726|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
535727|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
535728|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
535729|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
535730|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
535731|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
535732|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
535733|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
535734|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
535735|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
535738|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
535739|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
535740|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
535741|NCT00818753|E3|Reported Event|Heparin|Unfractionated heparin administered during intervention
535742|NCT00818753|E2|Reported Event|Dabigatran 150mg Bis in Die (BID)|
535743|NCT00818753|E1|Reported Event|Dabigatran 110mg Bis in Die (BID)|
535744|NCT00818766|B3|Baseline|Total|Total of all reporting groups
535745|NCT00818766|B2|Baseline|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535746|NCT00818766|B1|Baseline|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535747|NCT00818766|P2|Participant Flow|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535748|NCT00818766|P1|Participant Flow|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535749|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535750|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535751|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535752|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535753|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535754|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535755|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535756|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535757|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535758|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535759|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535760|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535761|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535762|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535763|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535764|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535765|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535766|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535767|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535768|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535769|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535770|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535771|NCT00818766|E2|Reported Event|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
535772|NCT00818766|E1|Reported Event|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
535773|NCT00818779|B3|Baseline|Total|Total of all reporting groups
535774|NCT00818779|B2|Baseline|Amlodipine|5-10 mg amlodipine once daily
535775|NCT00818779|B1|Baseline|Aliskiren|Aliskiren 150-300 mg once daily
535776|NCT00818779|P2|Participant Flow|Amlodipine|5-10 mg amlodipine once daily
535777|NCT00818779|P1|Participant Flow|Aliskiren|Aliskiren 150-300 mg once daily
535778|NCT00818779|O2|Outcome|Amlodipine|5-10 mg amlodipine once daily
535779|NCT00818779|O1|Outcome|Aliskiren|Aliskiren 150-300 mg once daily
535780|NCT00818779|E2|Reported Event|Amlodipine|5-10 mg amlodipine once daily
535781|NCT00818779|E1|Reported Event|Aliskiren|Aliskiren 150-300 mg once daily
535782|NCT00818805|B1|Baseline|Entire Study Population|
535783|NCT00818805|P2|Participant Flow|Tranilast 0.5% First, Then Olopatadine Second|Patients received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye first, then received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye last.
535784|NCT00818805|P1|Participant Flow|Olopatadine 0.1% First, Then Tranilast Second|Patients received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye first, then received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye next
535785|NCT00818805|O4|Outcome|Placebo (Tranilast)|Placebo (Tranilast) in one eye in either the first or second period
535786|NCT00818805|O3|Outcome|Placebo (Olopatadine)|Placebo (Olopatadine) in one eye in either the first or second period
535787|NCT00818805|O2|Outcome|Tranilast 0.5% One Eye|Tranilast 0.5% in one eye in either the first or second period
535788|NCT00818805|O1|Outcome|Olopatadine 0.1% One Eye|Olopatadine 0.1% in one eye in either the first or second period
535789|NCT00818805|E4|Reported Event|Placebo (Tranilast) One Eye|Placebo (Tranilast) in one eye in either the first or second period
535790|NCT00818805|E3|Reported Event|Placebo (Olopatadine) One Eye|Placebo (Olopatadine) in one eye in either the first or second period
535791|NCT00818805|E2|Reported Event|Tranilast 0.5% One Eye|Tranilast 0.5% in one eye in either the first or second period
535792|NCT00818805|E1|Reported Event|Olopatadine 0.1% One Eye|Olopatadine 0.1% in one eye in either the first or second period
535793|NCT00818883|B3|Baseline|Total|Total of all reporting groups
535794|NCT00818883|B2|Baseline|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535795|NCT00818883|B1|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535796|NCT00818883|P2|Participant Flow|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535797|NCT00818883|P1|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535798|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535841|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535966|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535799|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535800|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535801|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535802|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535803|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535804|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535805|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535806|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535807|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535808|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535809|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535810|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535811|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535812|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535813|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535814|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535815|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535816|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535842|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
543870|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
535817|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535818|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535819|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535820|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535821|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535822|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535823|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535824|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535825|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535826|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535827|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535828|NCT00818883|E2|Reported Event|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
535829|NCT00818883|E1|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
535830|NCT00818961|B1|Baseline|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535831|NCT00818961|P1|Participant Flow|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535832|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535833|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535834|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535835|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535836|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535837|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535838|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535839|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535840|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
535843|NCT00818961|E1|Reported Event|Hematopoietic Stem Cell Transplantation|All patients received a hematopoietic Stem Cell Transplantation as part of this clinical trial.
535844|NCT00819013|B5|Baseline|Total|Total of all reporting groups
535845|NCT00819013|B4|Baseline|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535846|NCT00819013|B3|Baseline|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535847|NCT00819013|B2|Baseline|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535848|NCT00819013|B1|Baseline|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535849|NCT00819013|P4|Participant Flow|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535850|NCT00819013|P3|Participant Flow|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535851|NCT00819013|P2|Participant Flow|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535852|NCT00819013|P1|Participant Flow|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535853|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535854|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535855|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535856|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535857|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535858|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535859|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535860|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535861|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535862|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535863|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535864|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535865|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535866|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535867|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535868|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535869|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535870|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535871|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535872|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535873|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535874|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535875|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535876|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535877|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535878|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535879|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535880|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535881|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535882|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535883|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535884|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535885|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535886|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535887|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535888|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535889|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535890|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535891|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535892|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535893|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535894|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535895|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535896|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535897|NCT00819013|E4|Reported Event|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
535898|NCT00819013|E3|Reported Event|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
535899|NCT00819013|E2|Reported Event|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
535900|NCT00819013|E1|Reported Event|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
535901|NCT00819039|B4|Baseline|Total|Total of all reporting groups
535902|NCT00819039|B3|Baseline|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535903|NCT00819039|B2|Baseline|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535904|NCT00819039|B1|Baseline|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535905|NCT00819039|P3|Participant Flow|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535906|NCT00819039|P2|Participant Flow|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535907|NCT00819039|P1|Participant Flow|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535908|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535909|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
535910|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535911|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
535912|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535913|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
535914|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535915|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
535916|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535917|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
535918|NCT00819039|O3|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535919|NCT00819039|O2|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
543871|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
535920|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535921|NCT00819039|O3|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535922|NCT00819039|O2|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535923|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535924|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535925|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535926|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535927|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535928|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535929|NCT00819039|E3|Reported Event|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535930|NCT00819039|E2|Reported Event|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535931|NCT00819039|E1|Reported Event|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
535932|NCT00819052|B3|Baseline|Total|Total of all reporting groups
535933|NCT00819052|B2|Baseline|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
535934|NCT00819052|B1|Baseline|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
535935|NCT00819052|P2|Participant Flow|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
535936|NCT00819052|P1|Participant Flow|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
535937|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
535938|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
535939|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
535940|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
535941|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
535942|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
535943|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
535944|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
535945|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
535946|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
535947|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
535948|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
535949|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
535950|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
535951|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535952|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535953|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535954|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535955|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535956|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535957|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535958|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535959|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535960|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535961|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535962|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535963|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535964|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535965|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535967|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535968|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535969|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535970|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535971|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535972|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535973|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535974|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535975|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535976|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535977|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535978|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535979|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535980|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535981|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535982|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535983|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535984|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535985|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535986|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535987|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535988|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535989|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535990|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535991|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535992|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535993|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535994|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535995|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535996|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
535997|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
535998|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
535999|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
536000|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
536001|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
536002|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
536003|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
536004|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
536005|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
536006|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
536007|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
536008|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
536009|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
536010|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
536011|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
536012|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
536013|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
536014|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
536015|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
536016|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
536017|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536018|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536019|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536020|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536021|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536022|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536023|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536024|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536025|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536026|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536027|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536028|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536029|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536030|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536031|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536032|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536033|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536034|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536035|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536036|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536037|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536038|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536039|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536040|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536041|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536042|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536043|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536044|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536045|NCT00819052|E2|Reported Event|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
536046|NCT00819052|E1|Reported Event|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
536047|NCT00819091|B3|Baseline|Total|Total of all reporting groups
536048|NCT00819091|B2|Baseline|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536049|NCT00819091|B1|Baseline|Placebo|Matching placebo tablet taken orally once daily
536050|NCT00819091|P2|Participant Flow|Linagliptin (BI 1356) 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536051|NCT00819091|P1|Participant Flow|Placebo|Matching placebo tablet taken orally once daily
536052|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536053|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
536054|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536055|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
536056|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536057|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
536058|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536059|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
536060|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536061|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
536062|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536063|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
536064|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536065|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
536066|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536067|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
536068|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536069|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
536070|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536071|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
536072|NCT00819091|E2|Reported Event|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
536073|NCT00819091|E1|Reported Event|Placebo|Matching placebo tablet taken orally once daily
536074|NCT00819156|B7|Baseline|Total|Total of all reporting groups
536075|NCT00819156|B6|Baseline|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536076|NCT00819156|B5|Baseline|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536077|NCT00819156|B4|Baseline|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536078|NCT00819156|B3|Baseline|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536079|NCT00819156|B2|Baseline|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536080|NCT00819156|B1|Baseline|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536081|NCT00819156|P6|Participant Flow|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536082|NCT00819156|P5|Participant Flow|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536083|NCT00819156|P4|Participant Flow|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536084|NCT00819156|P3|Participant Flow|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536085|NCT00819156|P2|Participant Flow|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536086|NCT00819156|P1|Participant Flow|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536087|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536088|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536089|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536090|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536091|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536092|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536093|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536094|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536095|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536096|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536097|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536098|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536099|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536100|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536101|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536102|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536103|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536104|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536105|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536106|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536107|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536108|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536109|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536110|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536111|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536112|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536113|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536114|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536115|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536423|NCT00819286|O2|Outcome|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
536116|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536117|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536118|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536119|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536120|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536121|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536122|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536123|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536124|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536125|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536126|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536127|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536128|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536129|NCT00819156|O5|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536130|NCT00819156|O4|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536131|NCT00819156|O3|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536132|NCT00819156|O2|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536133|NCT00819156|O1|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536134|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536135|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536136|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536137|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536138|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536139|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536140|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536141|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536142|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536143|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536144|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536145|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536146|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536147|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536148|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536149|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536349|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
536150|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536151|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536152|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536153|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536154|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536155|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536156|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536157|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536158|NCT00819156|O3|Outcome|Maintenance Dose of 160 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 160 milligram per cycle in cycles 2-13 have been combined.
536159|NCT00819156|O2|Outcome|Maintenance Dose of 120 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 120 milligram per cycle in cycles 2-13 have been combined.
536160|NCT00819156|O1|Outcome|Maintenance Dose of 80 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 80 milligram per cycle in cycles 2-13 have been combined.
536161|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536162|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536163|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536164|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536165|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536166|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536167|NCT00819156|E6|Reported Event|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536168|NCT00819156|E5|Reported Event|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536169|NCT00819156|E4|Reported Event|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536170|NCT00819156|E3|Reported Event|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
536171|NCT00819156|E2|Reported Event|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
536172|NCT00819156|E1|Reported Event|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
536173|NCT00819182|B4|Baseline|Total|Total of all reporting groups
536174|NCT00819182|B3|Baseline|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
536175|NCT00819182|B2|Baseline|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
536176|NCT00819182|B1|Baseline|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536177|NCT00819182|P3|Participant Flow|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
536178|NCT00819182|P2|Participant Flow|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
536194|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
536287|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536179|NCT00819182|P1|Participant Flow|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536180|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
536181|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536182|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536183|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536184|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
536185|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
536186|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536187|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
536188|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
536189|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536190|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
536191|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
536192|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536193|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
536195|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536196|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
536197|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
536198|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536199|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
536200|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
536201|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536202|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
536203|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
536204|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536205|NCT00819182|E3|Reported Event|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
536206|NCT00819182|E2|Reported Event|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
536207|NCT00819182|E1|Reported Event|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
536208|NCT00819234|B1|Baseline|All Participants|All participants who completed the original study and chose to enter the extension study.
536209|NCT00819234|P10|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536210|NCT00819234|P9|Participant Flow|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536421|NCT00819286|P2|Participant Flow|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
536211|NCT00819234|P8|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536212|NCT00819234|P7|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
536213|NCT00819234|P6|Participant Flow|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
536214|NCT00819234|P5|Participant Flow|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
536215|NCT00819234|P4|Participant Flow|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536216|NCT00819234|P3|Participant Flow|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536217|NCT00819234|P2|Participant Flow|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536218|NCT00819234|P1|Participant Flow|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536219|NCT00819234|O6|Outcome|360 mcg Pramlintide + Metreleptin 5 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536220|NCT00819234|O5|Outcome|360 mcg Pramlintide + Metreleptin 2.5 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536221|NCT00819234|O4|Outcome|360 mcg Pramlintide + Metreleptin 1.25 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536222|NCT00819234|O3|Outcome|360 mcg Pramlintide + Metreleptin 5 mg - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536223|NCT00819234|O2|Outcome|360 mcg Pramlintide + Metreleptin 2.5 mg - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536224|NCT00819234|O1|Outcome|360 mcg Pramlintide + Metreleptin 1.25 mg - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536225|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536226|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536227|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536228|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536285|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536229|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536230|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536231|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536232|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536233|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536234|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536235|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536236|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536237|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536238|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536239|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536240|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536241|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536242|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536243|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536244|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536245|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536246|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536286|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536422|NCT00819286|P1|Participant Flow|Wire (Control)|patients will have their sternum closed using stainless steel wires.
536247|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536248|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536249|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536250|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536251|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536252|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536253|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536254|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536255|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536256|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536257|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536258|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536259|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536260|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536261|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536262|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536263|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536264|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536265|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536266|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536267|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536268|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536269|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536270|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536271|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536272|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536273|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536274|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536275|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 5 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536276|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536277|NCT00819234|O1|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536278|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536279|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536280|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536281|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536282|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536283|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536284|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
543872|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
536288|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536289|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536290|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536291|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536292|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536293|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536294|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536295|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536296|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536297|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
536298|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536299|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536300|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536301|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536302|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536303|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536304|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536305|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536306|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536307|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
536308|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536309|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536310|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536311|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536312|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536313|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536314|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536315|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536316|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536317|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536318|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536319|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536320|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536321|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536322|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536323|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536324|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536325|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536326|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536327|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536328|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536329|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536330|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed, to minimize nausea and/or vomiting.
536331|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536332|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536333|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536334|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536335|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536336|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536337|NCT00819234|O1|Outcome|Placebo|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
536338|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
536339|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
536340|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
536341|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
536342|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
536343|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
536344|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
536345|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
536346|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
536347|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
536348|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
543873|NCT00832416|O4|Outcome|4: Placebo|
536350|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
536351|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
536352|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
536353|NCT00819234|O1|Outcome|Placebo|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
536354|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
536355|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
536356|NCT00819234|O1|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
536357|NCT00819234|O4|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
536358|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
536359|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
536360|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536361|NCT00819234|O4|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
536362|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
536363|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
536364|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536365|NCT00819234|E10|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536366|NCT00819234|E9|Reported Event|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536367|NCT00819234|E8|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
536368|NCT00819234|E7|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536369|NCT00819234|E6|Reported Event|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536370|NCT00819234|E5|Reported Event|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
536371|NCT00819234|E4|Reported Event|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536372|NCT00819234|E3|Reported Event|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536373|NCT00819234|E2|Reported Event|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E"
536374|NCT00819234|E1|Reported Event|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E."
536375|NCT00819247|B4|Baseline|Total|Total of all reporting groups
536376|NCT00819247|B3|Baseline|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
536377|NCT00819247|B2|Baseline|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536378|NCT00819247|B1|Baseline|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536379|NCT00819247|P3|Participant Flow|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
536380|NCT00819247|P2|Participant Flow|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536381|NCT00819247|P1|Participant Flow|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536382|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
536383|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536384|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536385|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
536386|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536387|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536388|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
536389|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536390|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536391|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
536392|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536393|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536394|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
536395|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536396|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536397|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
536398|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536399|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536400|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
536401|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536402|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536403|NCT00819247|E3|Reported Event|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
536404|NCT00819247|E2|Reported Event|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536405|NCT00819247|E1|Reported Event|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
536406|NCT00819260|B1|Baseline|All Participants|Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery.
536407|NCT00819260|P1|Participant Flow|All Participants|All participants were randomized to have one breast reduced using the harmonic scalpel and the other breast using electrocautery.
536408|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
536409|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
536410|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
536411|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
536412|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
536413|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
536414|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
536415|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
536416|NCT00819260|E2|Reported Event|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
536417|NCT00819260|E1|Reported Event|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
536418|NCT00819286|B3|Baseline|Total|Total of all reporting groups
536419|NCT00819286|B2|Baseline|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
536420|NCT00819286|B1|Baseline|Wire (Control)|patients will have their sternum closed using stainless steel wires.
536424|NCT00819286|O1|Outcome|Wire (Control)|patients will have their sternum closed using stainless steel wires.
536425|NCT00819286|O2|Outcome|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
536426|NCT00819286|O1|Outcome|Wire (Control)|patients will have their sternum closed using stainless steel wires.
536427|NCT00819286|E2|Reported Event|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
536428|NCT00819286|E1|Reported Event|Wire (Control)|patients will have their sternum closed using stainless steel wires.
536429|NCT00819390|B5|Baseline|Total|Total of all reporting groups
536430|NCT00819390|B4|Baseline|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536431|NCT00819390|B3|Baseline|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536432|NCT00819390|B2|Baseline|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536433|NCT00819390|B1|Baseline|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536434|NCT00819390|P4|Participant Flow|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536435|NCT00819390|P3|Participant Flow|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536436|NCT00819390|P2|Participant Flow|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536437|NCT00819390|P1|Participant Flow|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536438|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536439|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536440|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536441|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536442|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536443|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536444|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536445|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536446|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536447|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
538045|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
536448|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536449|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536450|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536451|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536452|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536453|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536454|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536455|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536456|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536457|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536458|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536459|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536460|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536461|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536462|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536463|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536464|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536465|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536466|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536467|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536712|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536468|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536469|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536470|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536471|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536472|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536473|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536474|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536475|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536476|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536477|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536478|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536479|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536480|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536481|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536482|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536483|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536484|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536485|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536486|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536487|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536718|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536488|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536489|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536490|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536491|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536492|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536493|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536494|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536495|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536496|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536497|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536498|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536499|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536500|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536501|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536502|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536503|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536504|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536505|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536506|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536507|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536771|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536508|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536509|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536510|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536511|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536512|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536513|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536514|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536515|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536516|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536517|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536518|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536519|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536520|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536521|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536522|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536523|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536524|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536525|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536526|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536527|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536772|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536528|NCT00819390|O2|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536529|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536530|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536531|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536532|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536533|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536534|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536535|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536536|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536537|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536538|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536539|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536540|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536541|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536542|NCT00819390|E4|Reported Event|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536543|NCT00819390|E3|Reported Event|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536544|NCT00819390|E2|Reported Event|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536545|NCT00819390|E1|Reported Event|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.
Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Placebo: Taken orally, once daily for 12 weeks."
536546|NCT00819403|B3|Baseline|Total|Total of all reporting groups
536547|NCT00819403|B2|Baseline|Simvastatin/Ezetimibe|"Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
536548|NCT00819403|B1|Baseline|Simvastatin|"Simvastatin 40 mg daily
simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
536713|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536549|NCT00819403|P2|Participant Flow|Simvastatin/Ezetimibe Then Simvastatin|Subjects will receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
536550|NCT00819403|P1|Participant Flow|Simvastatin Then Simvastatin/Ezetimibe|"Simvastatin 40 mg daily then simvastatin/ezetimibe 10/40 mg daily
Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied."
536551|NCT00819403|O2|Outcome|Simvastatin/Ezetimibe|Ezetimibe/simvastatin 10/40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
536552|NCT00819403|O1|Outcome|Simvastatin|Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
536553|NCT00819403|O2|Outcome|Simvastatin/Ezetimibe|Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
536554|NCT00819403|O1|Outcome|Simvastatin|Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
536555|NCT00819403|E2|Reported Event|Simvastatin/Ezetimibe|"Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
536556|NCT00819403|E1|Reported Event|Simvastatin|"Simvastatin 40 mg daily
simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
536557|NCT00819507|B1|Baseline|Vanos Cream|"glucocorticoid cream
Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
536558|NCT00819507|P1|Participant Flow|Vanos Cream|"glucocorticoid cream
Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
536559|NCT00819507|O1|Outcome|Vanos Cream|"glucocorticoid cream
Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
536560|NCT00819507|O1|Outcome|Vanos Cream|"glucocorticoid cream
Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
536561|NCT00819507|E1|Reported Event|Vanos Cream|"glucocorticoid cream
Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
536562|NCT00819585|B8|Baseline|Total|Total of all reporting groups
536563|NCT00819585|B7|Baseline|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536564|NCT00819585|B6|Baseline|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536565|NCT00819585|B5|Baseline|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536566|NCT00819585|B4|Baseline|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536567|NCT00819585|B3|Baseline|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536568|NCT00819585|B2|Baseline|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536569|NCT00819585|B1|Baseline|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536570|NCT00819585|P7|Participant Flow|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536571|NCT00819585|P6|Participant Flow|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536572|NCT00819585|P5|Participant Flow|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
538049|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
536573|NCT00819585|P4|Participant Flow|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536574|NCT00819585|P3|Participant Flow|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536575|NCT00819585|P2|Participant Flow|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536576|NCT00819585|P1|Participant Flow|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536577|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536578|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536579|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536580|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536581|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536582|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536583|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536584|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536585|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536586|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536587|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536588|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536714|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536589|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536590|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536591|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536592|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536593|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536594|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536595|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536596|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536597|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536598|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536599|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536600|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536601|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536602|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536603|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536604|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536715|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536605|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536606|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536607|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536608|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536609|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536610|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536611|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536612|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536613|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536614|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536615|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536616|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536617|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536618|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536619|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536620|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536716|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536621|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536622|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536623|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536624|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536625|NCT00819585|E7|Reported Event|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536626|NCT00819585|E6|Reported Event|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536627|NCT00819585|E5|Reported Event|Canakinumab 300mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.
536628|NCT00819585|E4|Reported Event|Canakinumab 200mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536629|NCT00819585|E3|Reported Event|Canakinumab 100mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536630|NCT00819585|E2|Reported Event|Canakinumab 50mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536631|NCT00819585|E1|Reported Event|Canakinumab 25mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
536632|NCT00819637|B4|Baseline|Total|Total of all reporting groups
536633|NCT00819637|B3|Baseline|Levalbuterol 3 Doses|
536634|NCT00819637|B2|Baseline|Arformoterol 3 Doses|
536635|NCT00819637|B1|Baseline|Arformoterol 1 Dose, Placebo 2 Doses|
536636|NCT00819637|P3|Participant Flow|Levalbuterol 3 Doses|
536637|NCT00819637|P2|Participant Flow|Arformoterol 3 Doses|
536638|NCT00819637|P1|Participant Flow|Arformoterol 1 Dose, Placebo 2 Doses|
536639|NCT00819637|O3|Outcome|Levalbuterol 3 Doses|
536640|NCT00819637|O2|Outcome|Arformoterol 3 Doses|
536641|NCT00819637|O1|Outcome|Arformoterol 1 Dose, Placebo 2 Doses|
536642|NCT00819637|E3|Reported Event|Levalbuterol 3 Doses|
536643|NCT00819637|E2|Reported Event|Arformoterol 3 Doses|
536644|NCT00819637|E1|Reported Event|Arformoterol 1 Dose, Placebo 2 Doses|
536645|NCT00819741|B3|Baseline|Total|Total of all reporting groups
536646|NCT00819741|B2|Baseline|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536647|NCT00819741|B1|Baseline|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536648|NCT00819741|P2|Participant Flow|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536649|NCT00819741|P1|Participant Flow|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536650|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536651|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536652|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536653|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536654|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536655|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536656|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536657|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536658|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536659|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536660|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536661|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536662|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536663|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536664|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536665|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536666|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536667|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536668|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536669|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536670|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536717|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
538251|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
536671|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536672|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536673|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536674|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536675|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536676|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536677|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536678|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536679|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536680|NCT00819741|E2|Reported Event|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
536681|NCT00819741|E1|Reported Event|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
536682|NCT00819767|B3|Baseline|Total|Total of all reporting groups
536683|NCT00819767|B2|Baseline|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536684|NCT00819767|B1|Baseline|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536685|NCT00819767|P2|Participant Flow|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536686|NCT00819767|P1|Participant Flow|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536687|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536688|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536773|NCT00819910|O3|Outcome|Rosiglitazone + Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
536689|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536690|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536691|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536692|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536693|NCT00819767|E2|Reported Event|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536694|NCT00819767|E1|Reported Event|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
536695|NCT00819780|B3|Baseline|Total|Total of all reporting groups
536696|NCT00819780|B2|Baseline|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536697|NCT00819780|B1|Baseline|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536698|NCT00819780|P2|Participant Flow|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2), followed by 5-FU (2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
536699|NCT00819780|P1|Participant Flow|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2) and 5-fluorouracil (5-FU; 2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
536700|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536701|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536702|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536703|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536704|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536705|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536706|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536707|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536708|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536709|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536710|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536711|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536774|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
536719|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536720|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536721|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536722|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536723|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536724|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536725|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536726|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536727|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536728|NCT00819780|E2|Reported Event|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536729|NCT00819780|E1|Reported Event|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
536730|NCT00819832|B7|Baseline|Total|Total of all reporting groups
536731|NCT00819832|B6|Baseline|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
536732|NCT00819832|B5|Baseline|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
536733|NCT00819832|B4|Baseline|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
536734|NCT00819832|B3|Baseline|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
536735|NCT00819832|B2|Baseline|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
536736|NCT00819832|B1|Baseline|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
536737|NCT00819832|P6|Participant Flow|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
536738|NCT00819832|P5|Participant Flow|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
536739|NCT00819832|P4|Participant Flow|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
536740|NCT00819832|P3|Participant Flow|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
536741|NCT00819832|P2|Participant Flow|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
536742|NCT00819832|P1|Participant Flow|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
536743|NCT00819832|O6|Outcome|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
536744|NCT00819832|O5|Outcome|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
536745|NCT00819832|O4|Outcome|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
536746|NCT00819832|O3|Outcome|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
536747|NCT00819832|O2|Outcome|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
536748|NCT00819832|O1|Outcome|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
536749|NCT00819832|E6|Reported Event|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
536750|NCT00819832|E5|Reported Event|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
536751|NCT00819832|E4|Reported Event|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
536752|NCT00819832|E3|Reported Event|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
536753|NCT00819832|E2|Reported Event|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
536754|NCT00819832|E1|Reported Event|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
536755|NCT00819910|B5|Baseline|Total|Total of all reporting groups
536756|NCT00819910|B4|Baseline|Placebo Therapy Daily|Placebo (Rosiglitazone 8mg once daily) and placebo (Fenofibrate 145 mg once daily) for 12 weeks
536757|NCT00819910|B3|Baseline|Rosiglitazone + Placebo|Rosiglitazone 8mg once daily and Placebo ( Fenofibrate 145mg once daily)
536758|NCT00819910|B2|Baseline|Fenofibrate + Placebo|Fenofibrate 145mg once daily for 12 weeks and Placebo (Rosiglitazone 8mg once daily)
536759|NCT00819910|B1|Baseline|Rosiglitazone/Fenofibrate Therapy Daily|Rosiglitazone 8mg once daily and Fenofibrate 145mg once daily for 12 weeks
536760|NCT00819910|P4|Participant Flow|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536761|NCT00819910|P3|Participant Flow|Rosiglitazone + Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
536762|NCT00819910|P2|Participant Flow|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
536763|NCT00819910|P1|Participant Flow|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536764|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536765|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
536766|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
536767|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536768|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536769|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
536770|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
536775|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536776|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536777|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
536778|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
536779|NCT00819910|O1|Outcome|Rosiglitazone and Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536780|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536781|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
536782|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
536783|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
536784|NCT00819910|E4|Reported Event|Placebo Therapy Daily|"Rosiglitazone (placebo) once daily and Fenofibrate (placebo)once daily for 12 weeks
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
536785|NCT00819910|E3|Reported Event|Fenofibrate + Placebo|"Fenofibrate 145 mg po daily for 12 weeks= Placebo (Rosiglitazone 8mg po daily)
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
536786|NCT00819910|E2|Reported Event|Rosiglitazone + Placebo|"Rosiglitazone 8mg po daily + Placebo (Fenofibrate 145 mg po daily) for 12 weeks
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
536787|NCT00819910|E1|Reported Event|Rosiglitazone/Fenofibrate Therapy Daily|"Rosiglitazone 8mg po daily + Fenofibrate 145 mg po daily for 12 weeks
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
536788|NCT00820222|B3|Baseline|Total|Total of all reporting groups
536789|NCT00820222|B2|Baseline|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536790|NCT00820222|B1|Baseline|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536791|NCT00820222|P2|Participant Flow|Trastuzumab Plus Capecitabine|Participants received an intravenous (IV) infusion of trastuzumab 8 mg/kilogram (kg) on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536792|NCT00820222|P1|Participant Flow|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536793|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536794|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536795|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536796|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536797|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
537685|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
536798|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536799|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536800|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536801|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536802|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536803|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536804|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536805|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536806|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536807|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536808|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536809|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536810|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536811|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
538252|NCT00824382|O1|Outcome|Placebo|Placebo
536812|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536813|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536814|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536815|NCT00820222|E2|Reported Event|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536816|NCT00820222|E1|Reported Event|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
536817|NCT00820248|B3|Baseline|Total|Total of all reporting groups
536818|NCT00820248|B2|Baseline|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.
panitumumab: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy"
536819|NCT00820248|B1|Baseline|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
cisplatin: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy"
536820|NCT00820248|P2|Participant Flow|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.
panitumumab: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy"
536821|NCT00820248|P1|Participant Flow|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
cisplatin: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy"
536822|NCT00820248|O2|Outcome|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.
panitumumab: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy"
536823|NCT00820248|O1|Outcome|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
cisplatin: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy"
536824|NCT00820248|O2|Outcome|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.
panitumumab: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy"
536825|NCT00820248|O1|Outcome|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
cisplatin: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy"
536826|NCT00820248|E2|Reported Event|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.
panitumumab: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy"
536827|NCT00820248|E1|Reported Event|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
cisplatin: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy"
536870|NCT00820573|O2|Outcome|Metformin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
536828|NCT00820443|B1|Baseline|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis
Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
536829|NCT00820443|P1|Participant Flow|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis
Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
536830|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis
Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
536831|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis
Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component"
536832|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis
Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
536833|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis
Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
536834|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis
Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
536835|NCT00820443|E1|Reported Event|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis
Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
536836|NCT00820534|B3|Baseline|Total|Total of all reporting groups
536837|NCT00820534|B2|Baseline|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
536838|NCT00820534|B1|Baseline|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
536839|NCT00820534|P2|Participant Flow|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
536840|NCT00820534|P1|Participant Flow|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
536841|NCT00820534|O2|Outcome|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
536842|NCT00820534|O1|Outcome|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
536843|NCT00820534|O2|Outcome|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
536844|NCT00820534|O1|Outcome|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
536845|NCT00820534|E2|Reported Event|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
536846|NCT00820534|E1|Reported Event|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
536847|NCT00820573|B5|Baseline|Total|Total of all reporting groups
536848|NCT00820573|B4|Baseline|Metformin Plus Sitagliptin|all subjects after receiving 6 weeks of combined sitagliptin plus metformin therpay
536849|NCT00820573|B3|Baseline|Sitagliptin|all subjects after receiving 6 weeks of sitagliptin therapy
536850|NCT00820573|B2|Baseline|Metformin|all subjects after receiving 6 weeks of metformin therapy
536851|NCT00820573|B1|Baseline|Placebo|all subjects after 6 weeks of placebo therapy
536852|NCT00820573|P4|Participant Flow|Sitagliptin Plus Metformin, Sitagliptin, Placebo,Metformin|Sequence as described, starting with combination sitagliptn plus metformin for 6 weeks, then sitagliptin 100 mg daily placebo therapy for 6 weeks and finally metforminfor 6 weeks.
536853|NCT00820573|P3|Participant Flow|Metformin, Sitagliptin Plus Metformin, Sitagliptin,Placebo|Sequence as described, starting with metformin 1000 mg twice daily for 6 weeks, combination sitagliptn plus metformin for 6 weeks, then sitagliptin 100 mg daily followed by placebo therapy for the final 6 weeks
536854|NCT00820573|P2|Participant Flow|Sitagliptin, Metformin, Sitagliptin Plus Metformin, Placebo|Sequence as described, starting with sitagliptin 100 mg once daily, then metformin 1000 mg twice daily for 6 weeks, combination sitagliptn plus metformin for 6 weeks and then placebo therapy for the final 6 weeks
536855|NCT00820573|P1|Participant Flow|Placebo,Sitagliptin,Metformin and Sitagliptin Plus Metformin|Sequence as described, starting placebo therapy for 6 weeks,followed by sitagliptin 100 mg once daily, then metformin 1000 mg twice daily for 6 weeks and the combination sitagliptn plus metformin for the final 6 weeks
536856|NCT00820573|O4|Outcome|Sitagliptin+Metformin|placebo for 6 weeks
536857|NCT00820573|O3|Outcome|Sitagliptin|"Sitagliptin + Metformin
Sitagliptin and Metformin : tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks"
536858|NCT00820573|O2|Outcome|Metformin|"Metformin
Metformin : tablet, 1000 mg/ bid, 6 weeks"
536859|NCT00820573|O1|Outcome|Placebo|"Sitagliptin
Sitagliptin : tablet, 100 mg/day, 6 weeks"
536860|NCT00820573|O4|Outcome|Sitagliptin + Metformin|placebo for 6 weeks
536861|NCT00820573|O3|Outcome|Sitagliptin|"Sitagliptin + Metformin
Sitagliptin and Metformin : tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks"
536862|NCT00820573|O2|Outcome|Metformin|"Metformin
Metformin : tablet, 1000 mg/ bid, 6 weeks"
536863|NCT00820573|O1|Outcome|Placebo|"Sitagliptin
Sitagliptin : tablet, 100 mg/day, 6 weeks"
536864|NCT00820573|O4|Outcome|Sitagliptin Plus Metformin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
536865|NCT00820573|O3|Outcome|Sitagliptin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
536866|NCT00820573|O2|Outcome|Metformin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
536867|NCT00820573|O1|Outcome|Placebo|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin.
536868|NCT00820573|O4|Outcome|Sitagliptin Plus Metformin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
536869|NCT00820573|O3|Outcome|Sitagliptin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
538253|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
536871|NCT00820573|O1|Outcome|Placebo|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
536872|NCT00820573|E4|Reported Event|Metformin Plus Sitagliptin|all subjects after receiving 6 weeks of combined sitagliptin plus metformin therpay
536873|NCT00820573|E3|Reported Event|Sitagliptin|all subjects after receiving 6 weeks of sitagliptin therapy
536874|NCT00820573|E2|Reported Event|Metformin|all subjects after receiving 6 weeks of metformin therapy
536875|NCT00820573|E1|Reported Event|Placebo|all subjects after 6 weeks of placebo therapy
536876|NCT00820612|B3|Baseline|Total|Total of all reporting groups
536877|NCT00820612|B2|Baseline|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
536878|NCT00820612|B1|Baseline|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
536879|NCT00820612|P2|Participant Flow|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
536880|NCT00820612|P1|Participant Flow|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
536881|NCT00820612|O2|Outcome|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
536882|NCT00820612|O1|Outcome|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
536883|NCT00820612|E2|Reported Event|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
536884|NCT00820612|E1|Reported Event|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
536885|NCT00820664|B4|Baseline|Total|Total of all reporting groups
536886|NCT00820664|B3|Baseline|Placebo|
536887|NCT00820664|B2|Baseline|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
536888|NCT00820664|B1|Baseline|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
536889|NCT00820664|P3|Participant Flow|Placebo|
536890|NCT00820664|P2|Participant Flow|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
536891|NCT00820664|P1|Participant Flow|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
536892|NCT00820664|O3|Outcome|Placebo|
536893|NCT00820664|O2|Outcome|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
536894|NCT00820664|O1|Outcome|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
536895|NCT00820664|E3|Reported Event|Placebo|
536896|NCT00820664|E2|Reported Event|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
536897|NCT00820664|E1|Reported Event|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
536898|NCT00820755|B1|Baseline|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
536899|NCT00820755|P3|Participant Flow|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
536900|NCT00820755|P2|Participant Flow|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
536901|NCT00820755|P1|Participant Flow|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
536902|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
536903|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
536904|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
536905|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
536906|NCT00820755|O1|Outcome|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
536907|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
536908|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
536909|NCT00820755|O1|Outcome|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
536910|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
536911|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
536912|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
536913|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
536914|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
536915|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
536916|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
536917|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
536918|NCT00820755|E3|Reported Event|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
536919|NCT00820755|E2|Reported Event|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression after combination therapy, they administered with cetuximab 500 mg/m^2 intravenously for 2 weeks, for up to PD, development of unacceptable toxicities, or withdrawal of consent after the end of combination therapy.
536939|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536940|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
543874|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
536920|NCT00820755|E1|Reported Event|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
536921|NCT00820872|B1|Baseline|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
536922|NCT00820872|P1|Participant Flow|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
536923|NCT00820872|O1|Outcome|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
536924|NCT00820872|E1|Reported Event|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
536925|NCT00814489|B4|Baseline|Total|Total of all reporting groups
536926|NCT00814489|B3|Baseline|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536927|NCT00814489|B2|Baseline|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted GSK2254232A Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536928|NCT00814489|B1|Baseline|GSK2254233A Group|Subjects received 2 doses of GSK2254233A adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2.The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536929|NCT00814489|P3|Participant Flow|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536930|NCT00814489|P2|Participant Flow|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536931|NCT00814489|P1|Participant Flow|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536932|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536933|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536934|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536935|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536936|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536937|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536938|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536941|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536942|NCT00814489|O2|Outcome|GSK2254232A Non-adjuvanted Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536943|NCT00814489|O1|Outcome|GSK2254232A Adjuvanted Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536944|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536945|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536946|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536947|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536948|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536949|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536950|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536951|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536952|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536953|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536954|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536955|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536956|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536957|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536958|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536959|NCT00814489|E3|Reported Event|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536960|NCT00814489|E2|Reported Event|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536961|NCT00814489|E1|Reported Event|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
536962|NCT00814502|B3|Baseline|Total|Total of all reporting groups
536963|NCT00814502|B2|Baseline|Placebo|"Subjects randomized to Placebo
Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
536964|NCT00814502|B1|Baseline|Zolpidem CR|"Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
536965|NCT00814502|P2|Participant Flow|Placebo|"Subjects randomized to Placebo
After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Placebo received Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
536966|NCT00814502|P1|Participant Flow|Zolpidem CR|"Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Zolpidem CR received Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
536967|NCT00814502|O2|Outcome|Placebo|"Subjects randomized to Placebo
Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
537008|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
536968|NCT00814502|O1|Outcome|Zolpidem CR|"Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
536969|NCT00814502|O2|Outcome|Placebo|"Subjects randomized to Placebo
Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
536970|NCT00814502|O1|Outcome|Zolpidem CR|"Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
536971|NCT00814502|O2|Outcome|Placebo|"Subjects randomized to Placebo
After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
536972|NCT00814502|O1|Outcome|Zolpidem CR|"Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
536973|NCT00814502|E2|Reported Event|Placebo|"Subjects randomized to Placebo
Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
536974|NCT00814502|E1|Reported Event|Zolpidem CR|"Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
536975|NCT00814580|B3|Baseline|Total|Total of all reporting groups
536976|NCT00814580|B2|Baseline|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
536977|NCT00814580|B1|Baseline|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
536978|NCT00814580|P2|Participant Flow|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
536979|NCT00814580|P1|Participant Flow|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
536980|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
536981|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
536982|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
536983|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
536984|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
536985|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
536986|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
536987|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
536988|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
536989|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
536990|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
536991|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
536992|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
536993|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
536994|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
536995|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
536996|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
536997|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
536998|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
536999|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
537000|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
537001|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
537002|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
537003|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
537004|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
537005|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
537006|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
537007|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
537009|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
537010|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
537011|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
537012|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
537013|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
537014|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
537015|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
537016|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
537017|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
537018|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
537019|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
537020|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
537021|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
537022|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
537023|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
537024|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
537025|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
537026|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
537027|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
537028|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
537029|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
537030|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
537031|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
537032|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
537033|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
537034|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
537035|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
537036|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
537037|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
537038|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
537039|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
537040|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
537041|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
537042|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
537043|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
537044|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
537045|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
537046|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
537047|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
537048|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
537049|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
537050|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
537051|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
537052|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
537053|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
537054|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
537055|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
537280|NCT00814801|E2|Reported Event|Galantamine Group 1|Galantamine 16 mg/day
537056|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
537057|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
537058|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
537059|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
537060|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
537061|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
537062|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
537063|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
537064|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537065|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537066|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537067|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537068|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537069|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537070|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537071|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537072|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537073|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537074|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537075|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537076|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537077|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537078|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537079|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537080|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537081|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537082|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537083|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537084|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537085|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537086|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537087|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537088|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537089|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537090|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537091|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537092|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537093|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537094|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537095|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537096|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537097|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537098|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537099|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537100|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537101|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537102|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537103|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537104|NCT00814580|E2|Reported Event|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
537105|NCT00814580|E1|Reported Event|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
537106|NCT00814632|B1|Baseline|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
537107|NCT00814632|P1|Participant Flow|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
537108|NCT00814632|O1|Outcome|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
537109|NCT00814632|E1|Reported Event|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
537110|NCT00814658|B3|Baseline|Total|Total of all reporting groups
537111|NCT00814658|B2|Baseline|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537112|NCT00814658|B1|Baseline|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537113|NCT00814658|P2|Participant Flow|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537114|NCT00814658|P1|Participant Flow|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537115|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537116|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537117|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537118|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537119|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537120|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537121|NCT00814658|O8|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537122|NCT00814658|O7|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537123|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 16)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537124|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 16)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537125|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537126|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537127|NCT00814658|O2|Outcome|Galantamine + Placebo (Week 4)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537128|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Week 4)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537129|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537130|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537131|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537132|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537133|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537134|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537135|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537136|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537137|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537138|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537139|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537140|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537141|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537142|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537143|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537144|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537145|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537146|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537147|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537148|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537149|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537150|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537151|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537152|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537153|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537281|NCT00814801|E1|Reported Event|Placebo Group|
537154|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537155|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537156|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537157|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537158|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537159|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537160|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537161|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537162|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537163|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537164|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537165|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537166|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537167|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537168|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537169|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537170|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537171|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537172|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537173|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537174|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537175|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537176|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537282|NCT00814879|B3|Baseline|Total|Total of all reporting groups
537177|NCT00814658|E2|Reported Event|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
537178|NCT00814658|E1|Reported Event|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
537179|NCT00814671|B4|Baseline|Total|Total of all reporting groups
537180|NCT00814671|B3|Baseline|RPT 600|"Rifapentine 600mg daily
Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537181|NCT00814671|B2|Baseline|RIF 600|"Rifampin 600mg daily
Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537182|NCT00814671|B1|Baseline|RPT450|"Rifapentine 450mg daily
Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537183|NCT00814671|P3|Participant Flow|RPT 600|"Rifapentine 600mg daily
Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537184|NCT00814671|P2|Participant Flow|RIF 600|"Rifampin 600mg daily
Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537185|NCT00814671|P1|Participant Flow|RPT450|"Rifapentine 450mg daily
Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537186|NCT00814671|O3|Outcome|RPT 600|"Rifapentine 600mg daily
Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537187|NCT00814671|O2|Outcome|RIF 600|"Rifampin 600mg daily
Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537188|NCT00814671|O1|Outcome|RPT450|"Rifapentine 450mg daily
Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537189|NCT00814671|O3|Outcome|RPT 600|"Rifapentine 600mg daily
Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537190|NCT00814671|O2|Outcome|RIF 600|"Rifampin 600mg daily
Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537191|NCT00814671|O1|Outcome|RPT450|"Rifapentine 450mg daily
Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537192|NCT00814671|E3|Reported Event|RPT 600|"Rifapentine 600mg daily
Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537193|NCT00814671|E2|Reported Event|RIF 600|"Rifampin 600mg daily
Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537194|NCT00814671|E1|Reported Event|RPT450|"Rifapentine 450mg daily
Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
537195|NCT00814697|B1|Baseline|rTMS|"rTMS treatment in Alzheimer's disease
Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
537196|NCT00814697|P1|Participant Flow|rTMS|"rTMS treatment in Alzheimer's disease
Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
537197|NCT00814697|O1|Outcome|Cognitive Assessment|"rTMS treatment in Alzheimer's disease
Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
537198|NCT00814697|E1|Reported Event|rTMS|"rTMS treatment in Alzheimer's disease
Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
537199|NCT00814710|B3|Baseline|Total|Total of all reporting groups
537200|NCT00814710|B2|Baseline|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537201|NCT00814710|B1|Baseline|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537202|NCT00814710|P2|Participant Flow|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537203|NCT00814710|P1|Participant Flow|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537204|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537205|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537206|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537207|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537208|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537209|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537210|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537211|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537212|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537213|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537214|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537215|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537216|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537217|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537218|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537219|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537220|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537221|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537222|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537223|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537224|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537225|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537226|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537227|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537228|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537229|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537230|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537231|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537232|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537233|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537367|NCT00821041|B1|Baseline|Waiting List Control|
537234|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537235|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537236|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537237|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537238|NCT00814710|E2|Reported Event|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537239|NCT00814710|E1|Reported Event|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
537240|NCT00814775|B3|Baseline|Total|Total of all reporting groups
537241|NCT00814775|B2|Baseline|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask
CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
537242|NCT00814775|B1|Baseline|Fastrach|"Fastrach Laryngeal Mask Airway intubation
Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
537243|NCT00814775|P2|Participant Flow|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask
CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
537244|NCT00814775|P1|Participant Flow|Fastrach|"Fastrach Laryngeal Mask Airway intubation
Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
537245|NCT00814775|O2|Outcome|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask
CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
537246|NCT00814775|O1|Outcome|Fastrach|"Fastrach Laryngeal Mask Airway intubation
Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
537247|NCT00814775|O2|Outcome|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask
CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
537248|NCT00814775|O1|Outcome|Fastrach|"Fastrach Laryngeal Mask Airway intubation
Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
537249|NCT00814775|E2|Reported Event|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask
CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
537250|NCT00814775|E1|Reported Event|Fastrach|"Fastrach Laryngeal Mask Airway intubation
Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
537251|NCT00814788|B1|Baseline|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
bicalutamide: Bicalutamide 50 mg oral daily
Everolimus: RAD001 10 mg oral capsule daily - continuously."
537252|NCT00814788|P1|Participant Flow|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bicalutamide 50 mg oral daily
Everolimus: RAD001 10 mg oral capsule daily - continuously."
537253|NCT00814788|O1|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bicalutamide: 50 mg oral tablet daily
Everolimus: 10 mg oral capsule daily"
537254|NCT00814788|O1|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bicalutamide 50 mg oral daily
Everolimus: RAD001 10 mg oral capsule daily - continuously."
537255|NCT00814788|O1|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
bicalutamide: Bicalutamide 50 mg oral daily
Everolimus: RAD001 10 mg oral capsule daily - continuously."
537256|NCT00814788|E1|Reported Event|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bicalutamide 50 mg oral daily
Everolimus: RAD001 10 mg oral capsule daily - continuously."
537257|NCT00814801|B4|Baseline|Total|Total of all reporting groups
537258|NCT00814801|B3|Baseline|Galantamine Group 2|Galantamine 24 mg/day
537259|NCT00814801|B2|Baseline|Galantamine Group 1|Galantamine 16 mg/day
537260|NCT00814801|B1|Baseline|Placebo Group|
537261|NCT00814801|P3|Participant Flow|Galantamine Group 2|Galantamine 24 mg/day
537262|NCT00814801|P2|Participant Flow|Galantamine Group 1|Galantamine 16 mg/day
537263|NCT00814801|P1|Participant Flow|Placebo Group|
537264|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
537265|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
537266|NCT00814801|O1|Outcome|Placebo Group|
537267|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
537268|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
537269|NCT00814801|O1|Outcome|Placebo Group|
537270|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
537271|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
537272|NCT00814801|O1|Outcome|Placebo Group|
537273|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
537274|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
537275|NCT00814801|O1|Outcome|Placebo Group|
537276|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
537277|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
537278|NCT00814801|O1|Outcome|Placebo Group|
537279|NCT00814801|E3|Reported Event|Galantamine Group 2|Galantamine 24 mg/day
537283|NCT00814879|B2|Baseline|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID
Raltegravir: 400 mg BID
Atazanavir: 300 mg BID"
537284|NCT00814879|B1|Baseline|N(t)NRTI + Plr|"N(t)RTI(s) based backbone & PI/r
Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
537285|NCT00814879|P2|Participant Flow|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID
Raltegravir: 400 mg BID
Atazanavir: 300 mg BID"
537286|NCT00814879|P1|Participant Flow|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r
Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
537287|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID
Raltegravir: 400 mg BID
Atazanavir: 300 mg BID"
537288|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r
Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
537289|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID
Raltegravir: 400 mg BID
Atazanavir: 300 mg BID"
537290|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r
Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
537291|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID
Raltegravir: 400 mg BID
Atazanavir: 300 mg BID"
537292|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r
Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
537293|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID
Raltegravir: 400 mg BID
Atazanavir: 300 mg BID"
537294|NCT00814879|O1|Outcome|N(t)NRTI + Plr|"N(t)RTI(s) based backbone & PI/r
Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
537295|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID
Raltegravir: 400 mg BID
Atazanavir: 300 mg BID"
537296|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r
Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
537297|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID
Raltegravir: 400 mg BID
Atazanavir: 300 mg BID"
537298|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r
Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
537299|NCT00814879|E2|Reported Event|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID
Raltegravir: 400 mg BID
Atazanavir: 300 mg BID"
537300|NCT00814879|E1|Reported Event|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r
Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
537301|NCT00814892|B1|Baseline|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
537302|NCT00814892|P1|Participant Flow|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
537303|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
537304|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
537305|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
537306|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
537307|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
537308|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
537309|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
537310|NCT00814892|E1|Reported Event|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
537311|NCT00814970|B1|Baseline|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537312|NCT00814970|P1|Participant Flow|Complete Self-expanding (SE) Vascular Stent System|"Device: Complete Self-expanding (SE) Vascular Stent System >
> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537313|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.
Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
537314|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.
Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
537315|NCT00814970|O1|Outcome|Complete Self-expanding (SE) Vascular Stent System|"Device: Complete Self-expanding (SE) Vascular Stent System >
> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537316|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.
Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
537317|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537318|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537319|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537320|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537321|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537322|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537323|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537324|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537325|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537326|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537327|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537328|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537329|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537330|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >
> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
537331|NCT00814970|E1|Reported Event|1. Complete SE Vascular Stent System|Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
537332|NCT00814983|B3|Baseline|Total|Total of all reporting groups
537333|NCT00814983|B2|Baseline|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
537368|NCT00821041|P2|Participant Flow|Cognitive Behavioral Therapy|
537369|NCT00821041|P1|Participant Flow|Waiting List Control|
537334|NCT00814983|B1|Baseline|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
537335|NCT00814983|P2|Participant Flow|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
537336|NCT00814983|P1|Participant Flow|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
537337|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
537338|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
537339|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
537340|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
537341|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
537342|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
537343|NCT00814983|E2|Reported Event|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
537344|NCT00814983|E1|Reported Event|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
537345|NCT00815035|B3|Baseline|Total|Total of all reporting groups
537346|NCT00815035|B2|Baseline|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.
Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
537347|NCT00815035|B1|Baseline|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537348|NCT00815035|P3|Participant Flow|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537349|NCT00815035|P2|Participant Flow|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.
Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
537350|NCT00815035|P1|Participant Flow|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537351|NCT00815035|O3|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537352|NCT00815035|O2|Outcome|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.
Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
537353|NCT00815035|O1|Outcome|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537354|NCT00815035|O3|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537355|NCT00815035|O2|Outcome|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.
Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
537356|NCT00815035|O1|Outcome|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537357|NCT00815035|O3|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537358|NCT00815035|O2|Outcome|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.
Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
537359|NCT00815035|O1|Outcome|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537360|NCT00815035|O1|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537361|NCT00815035|O1|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537362|NCT00815035|E3|Reported Event|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537363|NCT00815035|E2|Reported Event|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.
Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
537364|NCT00815035|E1|Reported Event|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.
Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
537365|NCT00821041|B3|Baseline|Total|Total of all reporting groups
537366|NCT00821041|B2|Baseline|Cognitive Behavioral Therapy|
537377|NCT00821093|B2|Baseline|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537378|NCT00821093|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537379|NCT00821093|P2|Participant Flow|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537380|NCT00821093|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537381|NCT00821093|O2|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537382|NCT00821093|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537383|NCT00821093|O2|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537384|NCT00821093|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537385|NCT00821093|E2|Reported Event|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537386|NCT00821093|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537387|NCT00821119|B3|Baseline|Total|Total of all reporting groups
537388|NCT00821119|B2|Baseline|2- NIPP|preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
537389|NCT00821119|B1|Baseline|1 - NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
537390|NCT00821119|P2|Participant Flow|Nasal Intermittent Positive Pressure Ventilation (NIPPV)|Nasal intermittent positive pressure ventilation as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life.We used a time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 – 6 cm H2O, inspiratory time (Ti) of 0.4 – 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 – 92%.
537391|NCT00821119|P1|Participant Flow|Nasal Continuous Positive Airway Pressure (NCPAP)|Continuous nasal positive airway pressure as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life. Infants randomized to the NCPAP group were initiated on a pressure of 5 – 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 – 92%.
537392|NCT00821119|O2|Outcome|NIPPV|Preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support. These infants were treated with time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 - 6 cm H2O, inspiratory time (Ti) of 0.4 - 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
537393|NCT00821119|O1|Outcome|NCPAP|Preterm infants with nasal continuous positive pressure as the mode of respiratory support.Infants randomized to the NCPAP group were initiated on a pressure of 5 - 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
537394|NCT00821119|O2|Outcome|NIPPV|Preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support. These infants were treated with time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 - 6 cm H2O, inspiratory time (Ti) of 0.4 - 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
537395|NCT00821119|O1|Outcome|NCPAP|Preterm infants with nasal continuous positive pressure as the mode of respiratory support.Infants randomized to the NCPAP group were initiated on a pressure of 5 - 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
537396|NCT00821119|O2|Outcome|NIPPV|preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
537397|NCT00821119|O1|Outcome|NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
537398|NCT00821119|E2|Reported Event|2- NIPP|preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
537399|NCT00821119|E1|Reported Event|1 - NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
537400|NCT00821184|B3|Baseline|Total|Total of all reporting groups
537401|NCT00821184|B2|Baseline|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
537402|NCT00821184|B1|Baseline|Vesicare Alone|Vesicare alone in treatment of incontinence
537403|NCT00821184|P2|Participant Flow|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
537404|NCT00821184|P1|Participant Flow|Vesicare Alone|Vesicare alone in treatment of incontinence
537405|NCT00821184|O2|Outcome|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
537406|NCT00821184|O1|Outcome|Vesicare Alone|Vesicare alone in treatment of incontinence
537407|NCT00821184|E2|Reported Event|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
537408|NCT00821184|E1|Reported Event|Vesicare Alone|Vesicare alone in treatment of incontinence
537409|NCT00821236|B4|Baseline|Total|Total of all reporting groups
537410|NCT00821236|B3|Baseline|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
537411|NCT00821236|B2|Baseline|AMO/VISX CustomVue|AMO/VISX CustomVue™
537412|NCT00821236|B1|Baseline|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
537413|NCT00821236|P1|Participant Flow|Lasik for Treatment of Nearsightedness|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment LADARVision 4000 excimer laser AMO/VISX CustomVue™ excimer laser treatment
537414|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
537415|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
537416|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
537417|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
537418|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
537419|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
537420|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
537421|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
537422|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
537423|NCT00821236|E3|Reported Event|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
537424|NCT00821236|E2|Reported Event|AMO/VISX CustomVue|AMO/VISX CustomVue™
537425|NCT00821236|E1|Reported Event|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
537426|NCT00821327|B1|Baseline|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
537451|NCT00822510|E2|Reported Event|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks"
537499|NCT00822523|E3|Reported Event|Placebo|"Saline, Single dose, Intramuscular injection into right EDB
Saline: Single Dose, Intramuscular into right EDB muscle"
537427|NCT00821327|P1|Participant Flow|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
537428|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
537429|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
537430|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
537431|NCT00821327|E1|Reported Event|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
537432|NCT00822510|B3|Baseline|Total|Total of all reporting groups
537433|NCT00822510|B2|Baseline|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks"
537434|NCT00822510|B1|Baseline|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
537435|NCT00822510|P2|Participant Flow|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks"
537436|NCT00822510|P1|Participant Flow|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
537437|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks"
537438|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
537439|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks"
537440|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
537441|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks"
537442|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
537443|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks"
537444|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
537445|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks"
537446|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
537447|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only. Educational topics included prostate cancer health, side effects, physical activity, diet. Participants were called on the telephone each week for about 30 minutes.
Telephone delivered education only: Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation"
537448|NCT00822510|O1|Outcome|Telephone Interpersonal Counseling|"Telephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes.
Telephone Interpersonal Counseling: Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy."
537449|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks
Telephone delivered education only: Telephone delivered education for 8 weeks"
537450|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
537452|NCT00822510|E1|Reported Event|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks
Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
537453|NCT00822523|B4|Baseline|Total|Total of all reporting groups
537454|NCT00822523|B3|Baseline|Placebo|"Saline, Single dose, Intramuscular injection into right EDB
Saline: Single Dose, Intramuscular into right EDB muscle"
537455|NCT00822523|B2|Baseline|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units
Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
537456|NCT00822523|B1|Baseline|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537457|NCT00822523|P3|Participant Flow|Placebo|"Saline, Single dose, Intramuscular injection into right EDB
Saline: Single Dose, Intramuscular into right EDB muscle"
537458|NCT00822523|P2|Participant Flow|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units
Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
537459|NCT00822523|P1|Participant Flow|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537460|NCT00822523|O2|Outcome|Surface EMG MRV-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 200 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537461|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537462|NCT00822523|O2|Outcome|Surface EMG MRV-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 500 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537463|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537464|NCT00822523|O2|Outcome|Surface EMG MRV-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 1000 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537465|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537466|NCT00822523|O2|Outcome|Surface EMG RMS-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 200 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537467|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537468|NCT00822523|O2|Outcome|Surface EMG RMS-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 500 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537469|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537470|NCT00822523|O2|Outcome|Surface EMG RMS-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 1000 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537471|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537472|NCT00822523|O2|Outcome|Surface EMG MRV-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 200 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537473|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537594|NCT00823043|P1|Participant Flow|Timolol Hemihydrate|Timolol hemihydrate 0.5% ophthalmic solution.
537474|NCT00822523|O2|Outcome|Surface EMG MRV-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 500 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537475|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537476|NCT00822523|O2|Outcome|Surface EMG MRV-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 1000 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537477|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537478|NCT00822523|O2|Outcome|Surface EMG RMS-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 200 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537479|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537480|NCT00822523|O2|Outcome|Surface EMG RMS-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 500 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537481|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537482|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB
Saline: Single Dose, Intramuscular into right EDB muscle"
537483|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units
Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
537484|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537485|NCT00822523|O2|Outcome|Surface EMG RMS-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 1000 ms interval
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537486|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe
Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537487|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB
Saline: Single Dose, Intramuscular into right EDB muscle"
537488|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units
Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
537489|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537490|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB
Saline: Single Dose, Intramuscular into right EDB muscle"
537491|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units
Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
537492|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537493|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB
Saline: Single Dose, Intramuscular into right EDB muscle"
537494|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units
Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
537495|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537496|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB
Saline: Single Dose, Intramuscular into right EDB muscle"
537497|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units
Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
537498|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537500|NCT00822523|E2|Reported Event|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units
Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
537501|NCT00822523|E1|Reported Event|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
537502|NCT00822588|B3|Baseline|Total|Total of all reporting groups
537503|NCT00822588|B2|Baseline|No Sangvia|No autologous blood transfusion.
537504|NCT00822588|B1|Baseline|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
537505|NCT00822588|P2|Participant Flow|No Sangvia|No autologous blood transfusion.
537506|NCT00822588|P1|Participant Flow|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
537507|NCT00822588|O2|Outcome|No Sangvia|No autologous blood transfusion.
537508|NCT00822588|O1|Outcome|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
537509|NCT00822588|E2|Reported Event|No Sangvia|No autologous blood transfusion.
537510|NCT00822588|E1|Reported Event|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
537511|NCT00822679|B3|Baseline|Total|Total of all reporting groups
537512|NCT00822679|B2|Baseline|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
Placebo: Subjects are given placebo for 3 consecutive nights"
537513|NCT00822679|B1|Baseline|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
537514|NCT00822679|P2|Participant Flow|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
Placebo: Subjects are given placebo for 3 consecutive nights"
537515|NCT00822679|P1|Participant Flow|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
537516|NCT00822679|O2|Outcome|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
Placebo: Subjects are given placebo for 3 consecutive nights"
537517|NCT00822679|O1|Outcome|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
537518|NCT00822679|E2|Reported Event|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
Placebo: Subjects are given placebo for 3 consecutive nights"
537519|NCT00822679|E1|Reported Event|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors
Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
537520|NCT00822692|B3|Baseline|Total|Total of all reporting groups
537521|NCT00822692|B2|Baseline|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
537522|NCT00822692|B1|Baseline|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
537523|NCT00822692|P2|Participant Flow|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
537524|NCT00822692|P1|Participant Flow|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
537525|NCT00822692|O2|Outcome|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
537526|NCT00822692|O1|Outcome|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
537527|NCT00822692|E2|Reported Event|Matched Placebo 2 Pills PO BID x 7 Days|matched placebo 2 pills PO BID x 7 days
537528|NCT00822692|E1|Reported Event|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|bactrim DS (800/160) two tablets PO BID x 7 days
537529|NCT00822757|B3|Baseline|Total|Total of all reporting groups
537530|NCT00822757|B2|Baseline|Placebo|Saline placebo single dose at baseline.
537531|NCT00822757|B1|Baseline|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
537532|NCT00822757|P2|Participant Flow|Placebo|Saline placebo single dose at baseline.
537533|NCT00822757|P1|Participant Flow|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
537534|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
537535|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
537536|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
537537|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
537538|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
537539|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
537540|NCT00822757|E2|Reported Event|Placebo|Saline placebo single dose at baseline.
537541|NCT00822757|E1|Reported Event|V710 (60 mcg) Lyophilized|V710 (60 mcg)single dose at baseline.
537542|NCT00822770|B1|Baseline|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant
Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)
Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.
Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.
ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.
Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.
Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.
Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
537595|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
537596|NCT00823043|O1|Outcome|Timolol Hemihydrate|
537597|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
537543|NCT00822770|P1|Participant Flow|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant
Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)
Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.
Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.
Thymoglobulin (ATG) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.
Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.
Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.
Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
537544|NCT00822770|O1|Outcome|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant
Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)
Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.
Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.
ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.
Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.
Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.
Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
537545|NCT00822770|E1|Reported Event|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant
Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)
Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.
Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.
ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.
Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.
Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.
Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
537546|NCT00822900|B3|Baseline|Total|Total of all reporting groups
537547|NCT00822900|B2|Baseline|Placebo|
537548|NCT00822900|B1|Baseline|Progesterone|
537549|NCT00822900|P2|Participant Flow|Placebo|
537550|NCT00822900|P1|Participant Flow|Progesterone|
537551|NCT00822900|O2|Outcome|Placebo|
537552|NCT00822900|O1|Outcome|Progesterone|
537553|NCT00822900|O2|Outcome|Placebo|
537554|NCT00822900|O1|Outcome|Progesterone|
537555|NCT00822900|O2|Outcome|Placebo|
537556|NCT00822900|O1|Outcome|Progesterone|
537557|NCT00822900|O2|Outcome|Placebo|
537558|NCT00822900|O1|Outcome|Progesterone|
537559|NCT00822900|O2|Outcome|Placebo|
537560|NCT00822900|O1|Outcome|Progesterone|
537561|NCT00822900|O2|Outcome|Placebo|
537562|NCT00822900|O1|Outcome|Progesterone|
537563|NCT00822900|O2|Outcome|Placebo|
537564|NCT00822900|O1|Outcome|Progesterone|
537565|NCT00822900|O2|Outcome|Placebo|
537566|NCT00822900|O1|Outcome|Progesterone|
537567|NCT00822900|O2|Outcome|Placebo|
537568|NCT00822900|O1|Outcome|Progesterone|
537569|NCT00822900|O2|Outcome|Placebo|
537570|NCT00822900|O1|Outcome|Progesterone|
537571|NCT00822900|O2|Outcome|Placebo|
537572|NCT00822900|O1|Outcome|Progesterone|
537573|NCT00822900|O2|Outcome|Placebo|
537574|NCT00822900|O1|Outcome|Progesterone|
537575|NCT00822900|E2|Reported Event|Placebo|
537576|NCT00822900|E1|Reported Event|Progesterone|
537577|NCT00822926|B3|Baseline|Total|Total of all reporting groups
537578|NCT00822926|B2|Baseline|Botox Then Placebo|Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
537579|NCT00822926|B1|Baseline|Placebo Then Botox|Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
537580|NCT00822926|P2|Participant Flow|Botox Then Placebo|Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
537581|NCT00822926|P1|Participant Flow|Placebo Then Botox|Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
537582|NCT00822926|O3|Outcome|Botox|Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
537583|NCT00822926|O2|Outcome|Placebo|Saline- Subcutaneous injection of saline into scar tissue
537584|NCT00822926|O1|Outcome|Baseline|
537585|NCT00822926|O3|Outcome|Botox|Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
537586|NCT00822926|O2|Outcome|Placebo|Saline- Subcutaneous injection of saline into scar tissue
537587|NCT00822926|O1|Outcome|Baseline|
537588|NCT00822926|O2|Outcome|Botox|Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
537589|NCT00822926|O1|Outcome|Placebo|Saline- Subcutaneous injection of saline into scar tissue
537590|NCT00822926|E2|Reported Event|Botox Then Placebo|Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
537591|NCT00822926|E1|Reported Event|Placebo Then Botox|Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
537592|NCT00823043|B1|Baseline|Total Subject Population|All subjects responding to survey
537593|NCT00823043|P2|Participant Flow|Timolol Maleate in Sorbate|Timolol maleate in sorbate 0.5% ophthalmic solution
537598|NCT00823043|O1|Outcome|Timolol Hemihydrate|
537604|NCT00823069|B1|Baseline|Perlane and Perlane-L|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
537605|NCT00823069|P1|Participant Flow|Perlane-L and Perlane|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
537606|NCT00823069|O2|Outcome|Perlane|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
537607|NCT00823069|O1|Outcome|Perlane-L|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
537608|NCT00823069|O1|Outcome|Perlane-L and Perlane|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
537609|NCT00823069|E2|Reported Event|Perlane|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
537610|NCT00823069|E1|Reported Event|Perlane-L|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
537611|NCT00823082|B3|Baseline|Total|Total of all reporting groups
537612|NCT00823082|B2|Baseline|Control Group|No preoperative ATIII supplementation administered
537613|NCT00823082|B1|Baseline|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537614|NCT00823082|P2|Participant Flow|Control Group|No preoperative ATIII supplementation administered
537615|NCT00823082|P1|Participant Flow|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537616|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537617|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537618|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537619|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537620|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537621|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537622|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537623|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537624|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537625|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537626|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537627|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537628|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537629|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537630|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537631|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537632|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537633|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537634|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537635|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537636|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537637|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537638|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537639|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537640|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537641|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537642|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537643|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537644|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
537645|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537646|NCT00823082|E2|Reported Event|Control Group|No preoperative ATII supplementation administered
537647|NCT00823082|E1|Reported Event|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction
Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
537648|NCT00823095|B1|Baseline|Group 1|Treatment
537649|NCT00823095|P1|Participant Flow|Topically Applied Nitric Oxide|Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
537650|NCT00823095|O1|Outcome|Treatment|reduction in bioburden as assessed by number of cfu's per cm2 on culture
537651|NCT00823095|O1|Outcome|Group 1|Treatment
537652|NCT00823095|E1|Reported Event|Group 1|Treatment
537653|NCT00823199|B1|Baseline|Group 1|
537654|NCT00823199|P1|Participant Flow|Allopurinal Treatment|
537655|NCT00823199|O1|Outcome|Allopurinal Treatment|
537656|NCT00823199|O1|Outcome|Allopurinal Treatment|
537657|NCT00823199|O1|Outcome|Allopurinal Treatment|
537658|NCT00823199|E1|Reported Event|Group 1|
537659|NCT00823212|B3|Baseline|Total|Total of all reporting groups
537660|NCT00823212|B2|Baseline|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537661|NCT00823212|B1|Baseline|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537662|NCT00823212|P2|Participant Flow|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537663|NCT00823212|P1|Participant Flow|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537664|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537665|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537666|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537667|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537668|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537669|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537670|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537671|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537672|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537673|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537674|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537675|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537676|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537677|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537678|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537679|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537680|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537681|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537682|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537683|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537684|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537686|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537687|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537688|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537689|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537690|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537691|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537692|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537693|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537694|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537695|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537696|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537697|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537698|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537699|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537700|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537701|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537702|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537703|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537704|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537705|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537706|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537707|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537708|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537709|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537710|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537711|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537712|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537713|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537714|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537715|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537716|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537717|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537718|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537719|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537720|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537721|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537722|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537723|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537724|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537725|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537726|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537727|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537728|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537729|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537730|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537731|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537732|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537733|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
543875|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
537734|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537735|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537736|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537737|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537738|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537739|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537740|NCT00823212|O2|Outcome|PROMUS Element|PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
537741|NCT00823212|O1|Outcome|PROMUS|PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
537742|NCT00823212|E2|Reported Event|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
537743|NCT00823212|E1|Reported Event|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
537744|NCT00823264|B3|Baseline|Total|Total of all reporting groups
537745|NCT00823264|B2|Baseline|Multiple Doses of Activated Charcoal|Will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels are < 25 ug/cc.
537746|NCT00823264|B1|Baseline|Control|Will not receive activated charcoal. Serum levels will be followed.
537747|NCT00823264|P2|Participant Flow|Multiple Doses of Activated Charcoal|Will receive 50 grams of activated charcoal every 4 hours by mouth until phenytoin level is < 25 ug/cc.
537748|NCT00823264|P1|Participant Flow|Control|Will not receive activated charcoal. Serum levels will be followed.
537749|NCT00823264|O2|Outcome|Multiple Doses of Activated Charcoal|Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
537750|NCT00823264|O1|Outcome|Control|Will not receive activated charcoal. Serum levels will be followed.
537751|NCT00823264|E2|Reported Event|Control|Will not receive activated charcoal. Serum levels will be followed.
537752|NCT00823264|E1|Reported Event|Multiple Doses of Charcoal|Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
537753|NCT00823303|B3|Baseline|Total|Total of all reporting groups
537754|NCT00823303|B2|Baseline|Calcitriol|"titrated to achieve 40-60% PTH suppression
Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
537755|NCT00823303|B1|Baseline|Paricalcitol|"titrated to achieve 40-60% PTH suppression
Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
537756|NCT00823303|P2|Participant Flow|Calcitriol|"titrated to achieve 40-60% PTH suppression
Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
537757|NCT00823303|P1|Participant Flow|Paricalcitol|"titrated to achieve 40-60% PTH suppression
Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
537758|NCT00823303|O2|Outcome|Calcitriol|"titrated to achieve 40-60% PTH suppression
Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
537759|NCT00823303|O1|Outcome|Paricalcitol|"titrated to achieve 40-60% PTH suppression
Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
537760|NCT00823303|E2|Reported Event|Calcitriol|"titrated to achieve 40-60% PTH suppression
Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
537761|NCT00823303|E1|Reported Event|Paricalcitol|"titrated to achieve 40-60% PTH suppression
Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
537762|NCT00823472|B3|Baseline|Total|Total of all reporting groups
537763|NCT00823472|B2|Baseline|Start rFSH on Cycle Day 5|
537764|NCT00823472|B1|Baseline|Start rFSH Cycle Day 2|
537765|NCT00823472|P2|Participant Flow|Start rFSH on Cycle Day 5|
537766|NCT00823472|P1|Participant Flow|Start rFSH Cycle Day 2|
537767|NCT00823472|O2|Outcome|Start rFSH on Cycle Day 5|
537768|NCT00823472|O1|Outcome|Start rFSH Cycle Day 2|
537769|NCT00823472|O2|Outcome|Start rFSH on Cycle Day 5|
537770|NCT00823472|O1|Outcome|Start rFSH Cycle Day 2|
537771|NCT00823472|E2|Reported Event|Start rFSH on Cycle Day 5|
537772|NCT00823472|E1|Reported Event|Start rFSH Cycle Day 2|
537773|NCT00823615|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects
537774|NCT00823615|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A multifocal contact lens worn first, followed by Lotrafilcon B multifocal contact lens worn second. Both products were worn on a daily-wear basis.
537775|NCT00823615|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B multifocal contact lens worn first, followed by Senofilcon A multifocal contact lens worn second. Both products were worn on a daily-wear basis.
537776|NCT00823615|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
537777|NCT00823615|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
537778|NCT00823615|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
537779|NCT00823615|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
537780|NCT00823615|E2|Reported Event|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
537781|NCT00823615|E1|Reported Event|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
537782|NCT00823719|B3|Baseline|Total|Total of all reporting groups
537783|NCT00823719|B2|Baseline|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537784|NCT00823719|B1|Baseline|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537785|NCT00823719|P2|Participant Flow|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537786|NCT00823719|P1|Participant Flow|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537787|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537788|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537789|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537790|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537791|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537792|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537793|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
538254|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
537794|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537795|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537796|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537797|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537798|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537799|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537800|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537801|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537802|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537803|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537854|NCT00823823|B1|Baseline|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
537804|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537805|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537806|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537807|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537808|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537809|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537810|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537811|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537812|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537813|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
538046|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
537814|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537815|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537816|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537817|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537818|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537819|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537820|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537821|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537822|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537823|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537824|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537825|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537826|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537827|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537828|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537829|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537830|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537831|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537832|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537833|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537855|NCT00823823|P2|Participant Flow|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
537834|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537835|NCT00823719|E3|Reported Event|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537836|NCT00823719|E2|Reported Event|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
537837|NCT00823719|E1|Reported Event|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
537838|NCT00823797|B3|Baseline|Total|Total of all reporting groups
537839|NCT00823797|B2|Baseline|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537840|NCT00823797|B1|Baseline|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537841|NCT00823797|P2|Participant Flow|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537842|NCT00823797|P1|Participant Flow|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537843|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537844|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537845|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537846|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537847|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537848|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537849|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537850|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
537851|NCT00823797|E1|Reported Event|Treatment (Bendamustine Hydrochloride)|"Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Quality-of-Life Assessment: Ancillary studies"
537852|NCT00823823|B3|Baseline|Total|Total of all reporting groups
537853|NCT00823823|B2|Baseline|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
537856|NCT00823823|P1|Participant Flow|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
537857|NCT00823823|O2|Outcome|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
537858|NCT00823823|O1|Outcome|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
537859|NCT00823823|O2|Outcome|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
537860|NCT00823823|O1|Outcome|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
537861|NCT00823823|E2|Reported Event|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
537862|NCT00823823|E1|Reported Event|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
537863|NCT00823836|B3|Baseline|Total|Total of all reporting groups
537864|NCT00823836|B2|Baseline|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537865|NCT00823836|B1|Baseline|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537866|NCT00823836|P2|Participant Flow|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537867|NCT00823836|P1|Participant Flow|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537868|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537869|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537904|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537870|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537871|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537872|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537873|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537874|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537875|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537876|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537877|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537987|NCT00823979|B1|Baseline|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538047|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538048|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
537878|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537879|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537880|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537881|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537882|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537883|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537884|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537885|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537988|NCT00823979|P3|Participant Flow|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537989|NCT00823979|P2|Participant Flow|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537886|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537887|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537888|NCT00823836|O1|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537889|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537890|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537891|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537892|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537893|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537894|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537895|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537896|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537897|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537898|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537899|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537900|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537901|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537902|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537903|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537905|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537906|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537907|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537908|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537909|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537910|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537911|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537912|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537913|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537914|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537915|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537916|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537917|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537918|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537919|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537920|NCT00823836|O1|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537921|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537922|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537923|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537924|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537925|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537926|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537927|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537928|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537929|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537930|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537931|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537932|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537933|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537934|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537935|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537936|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537937|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537938|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537939|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537940|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537941|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537942|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537943|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537944|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537945|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537946|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537947|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537948|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537949|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537950|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537951|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537952|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537953|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537954|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537955|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537956|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537957|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537958|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537959|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537960|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537961|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537962|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537963|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537964|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537965|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537966|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537990|NCT00823979|P1|Participant Flow|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537991|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537967|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537968|NCT00823836|E2|Reported Event|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537969|NCT00823836|E1|Reported Event|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
537970|NCT00823901|B3|Baseline|Total|Total of all reporting groups
537971|NCT00823901|B2|Baseline|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
537972|NCT00823901|B1|Baseline|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
537973|NCT00823901|P2|Participant Flow|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
537974|NCT00823901|P1|Participant Flow|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
537975|NCT00823901|O2|Outcome|Placebo|Participants applied placebo gel without active ingredient on entire face (forehead, nose, cheek, chin)once daily at night for 12 weeks
537976|NCT00823901|O1|Outcome|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
537977|NCT00823901|E2|Reported Event|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
537978|NCT00823901|E1|Reported Event|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
537979|NCT00823966|B1|Baseline|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
537980|NCT00823966|P1|Participant Flow|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
537981|NCT00823966|O1|Outcome|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
537982|NCT00823966|O1|Outcome|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
537983|NCT00823966|E1|Reported Event|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
537984|NCT00823979|B4|Baseline|Total|Total of all reporting groups
537985|NCT00823979|B3|Baseline|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537986|NCT00823979|B2|Baseline|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537992|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
543876|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
537993|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537994|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537995|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537996|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537997|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537998|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
537999|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538000|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538001|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538002|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538003|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538004|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538005|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538006|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538007|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538008|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538009|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538010|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538011|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538012|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538013|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538014|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538015|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538016|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538017|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538018|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538019|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538020|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538021|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538022|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538023|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538024|NCT00823979|E3|Reported Event|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538025|NCT00823979|E2|Reported Event|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538026|NCT00823979|E1|Reported Event|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
538027|NCT00824005|B3|Baseline|Total|Total of all reporting groups
538028|NCT00824005|B2|Baseline|Active Stem Cell Injections|Participants will receive active stem cell injections.
538029|NCT00824005|B1|Baseline|Placebo Injections|Participants will receive placebo injections.
538030|NCT00824005|P2|Participant Flow|Active Stem Cell Injections|Participants will receive active stem cell injections.
538031|NCT00824005|P1|Participant Flow|Placebo Injections|Participants will receive placebo injections.
538032|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538033|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538034|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538035|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538036|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538037|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538038|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538039|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538040|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538041|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538042|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538043|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538044|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538050|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538051|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538052|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538053|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538054|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538055|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538056|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538057|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538058|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
538059|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
538060|NCT00824005|E2|Reported Event|Active Stem Cell Injections|Participants received active stem cell injections.
538061|NCT00824005|E1|Reported Event|Placebo Injections|Participants received placebo injections.
538062|NCT00824044|B3|Baseline|Total|Total of all reporting groups
538063|NCT00824044|B2|Baseline|Escitalopram|
538064|NCT00824044|B1|Baseline|Cognitive Behavioral Therapy (CBT)|
538065|NCT00824044|P2|Participant Flow|Escitalopram|
538066|NCT00824044|P1|Participant Flow|Cognitive Behavioral Therapy (CBT)|
538067|NCT00824044|O2|Outcome|Escitalopram|Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.
538068|NCT00824044|O1|Outcome|Cognitive Behavioral Therapy (CBT)|Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.
538069|NCT00824044|E2|Reported Event|Escitalopram|
538070|NCT00824044|E1|Reported Event|Cognitive Behavioral Therapy (CBT)|
538071|NCT00824070|B4|Baseline|Total|Total of all reporting groups
538072|NCT00824070|B3|Baseline|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
538073|NCT00824070|B2|Baseline|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
538074|NCT00824070|B1|Baseline|Besifloxacin|Besifloxacin ophthalmic suspension
538075|NCT00824070|P3|Participant Flow|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
538076|NCT00824070|P2|Participant Flow|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
538077|NCT00824070|P1|Participant Flow|Besifloxacin|Besifloxacin ophthalmic suspension
538078|NCT00824070|O3|Outcome|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
538079|NCT00824070|O2|Outcome|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
538080|NCT00824070|O1|Outcome|Besifloxacin|Besifloxacin ophthalmic suspension
538081|NCT00824070|E3|Reported Event|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
538082|NCT00824070|E2|Reported Event|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
538083|NCT00824070|E1|Reported Event|Besifloxacin|Besifloxacin ophthalmic suspension
538084|NCT00824161|B1|Baseline|TAS-109|TAS-109 2.0 mg/m^2/day
538085|NCT00824161|P1|Participant Flow|TAS-109|TAS-109 2.0 mg/m^2/day
538086|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day
538087|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day
538088|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day Independent Assessment
538089|NCT00824161|E1|Reported Event|TAS-109|TAS-109 2.0 mg/m^2/day
538090|NCT00824265|B3|Baseline|Total|Total of all reporting groups
538091|NCT00824265|B2|Baseline|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538092|NCT00824265|B1|Baseline|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538093|NCT00824265|P2|Participant Flow|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538094|NCT00824265|P1|Participant Flow|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538095|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538154|NCT00824291|B1|Baseline|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
538096|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538097|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538098|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538099|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538100|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538101|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538102|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538103|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538104|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538105|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538106|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538107|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538108|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538109|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538110|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538111|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538112|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538113|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538114|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538115|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538116|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538117|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538118|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538119|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538120|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538121|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538122|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538123|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538155|NCT00824291|P2|Participant Flow|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
538255|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538256|NCT00824382|O1|Outcome|Placebo|Placebo
538124|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538125|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538126|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538127|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538128|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538129|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538130|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538131|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538132|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538133|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538134|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538135|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538136|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538137|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538156|NCT00824291|P1|Participant Flow|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
538157|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
538138|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538139|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538140|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538141|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538142|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538143|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538144|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538145|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538146|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538147|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538148|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538149|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538150|NCT00824265|E2|Reported Event|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538151|NCT00824265|E1|Reported Event|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
538152|NCT00824291|B3|Baseline|Total|Total of all reporting groups
538153|NCT00824291|B2|Baseline|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
543877|NCT00832416|E4|Reported Event|4: Placebo|
538158|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
538159|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
538160|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
538161|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
538162|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
538163|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
538164|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
538165|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
538166|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
538167|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
538168|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
538169|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
538170|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
538171|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
538172|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
538173|NCT00824291|E2|Reported Event|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
538174|NCT00824291|E1|Reported Event|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
538175|NCT00824369|B7|Baseline|Total|Total of all reporting groups
538176|NCT00824369|B6|Baseline|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
538177|NCT00824369|B5|Baseline|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
538178|NCT00824369|B4|Baseline|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
538179|NCT00824369|B3|Baseline|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
538180|NCT00824369|B2|Baseline|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
538181|NCT00824369|B1|Baseline|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
538182|NCT00824369|P6|Participant Flow|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
538183|NCT00824369|P5|Participant Flow|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
538184|NCT00824369|P4|Participant Flow|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
538185|NCT00824369|P3|Participant Flow|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
538186|NCT00824369|P2|Participant Flow|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
538187|NCT00824369|P1|Participant Flow|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
538188|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
538189|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
538190|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
538191|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
538192|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
538193|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
538194|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
538195|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
538196|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
538197|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
538198|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
538250|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538199|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
538200|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
538201|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
538202|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
538203|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
538204|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
538205|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
538206|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
538207|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
538208|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
538209|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
538210|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
538211|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
538212|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
538213|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
538214|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
538215|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
538216|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
538217|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
538218|NCT00824369|E6|Reported Event|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
538219|NCT00824369|E5|Reported Event|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
538220|NCT00824369|E4|Reported Event|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
538221|NCT00824369|E3|Reported Event|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
538222|NCT00824369|E2|Reported Event|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
538223|NCT00824369|E1|Reported Event|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
538224|NCT00824382|B5|Baseline|Total|Total of all reporting groups
538225|NCT00824382|B4|Baseline|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538226|NCT00824382|B3|Baseline|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538227|NCT00824382|B2|Baseline|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538228|NCT00824382|B1|Baseline|Placebo|Placebo
538229|NCT00824382|P4|Participant Flow|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538230|NCT00824382|P3|Participant Flow|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538231|NCT00824382|P2|Participant Flow|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538232|NCT00824382|P1|Participant Flow|Placebo|Placebo
538233|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538234|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538235|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538236|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538237|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538238|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538239|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538240|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538241|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538242|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538243|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538244|NCT00824382|O1|Outcome|Placebo|Placebo
538245|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538246|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538247|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538248|NCT00824382|O1|Outcome|Placebo|Placebo
538249|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538257|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538258|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538259|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538260|NCT00824382|O1|Outcome|Placebo|Placebo
538261|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538262|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538263|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538264|NCT00824382|O1|Outcome|Placebo|Placebo
538265|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538266|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538267|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538268|NCT00824382|O1|Outcome|Placebo|Placebo
538269|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538270|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538271|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538272|NCT00824382|O1|Outcome|Placebo|Placebo
538273|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538274|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538275|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538276|NCT00824382|O1|Outcome|Placebo|Placebo
538277|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538278|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538279|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538280|NCT00824382|O1|Outcome|Placebo|Placebo
538281|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538282|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538283|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538284|NCT00824382|O1|Outcome|Placebo|Placebo
538285|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538286|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538287|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538288|NCT00824382|O1|Outcome|Placebo|Placebo
538289|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538290|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538291|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538292|NCT00824382|O1|Outcome|Placebo|Placebo
538293|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538294|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538295|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538296|NCT00824382|O1|Outcome|Placebo|Placebo
538297|NCT00824382|E4|Reported Event|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
538298|NCT00824382|E3|Reported Event|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
538299|NCT00824382|E2|Reported Event|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
538300|NCT00824382|E1|Reported Event|Placebo|Placebo
538301|NCT00824408|B6|Baseline|Total|Total of all reporting groups
538302|NCT00824408|B5|Baseline|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538303|NCT00824408|B4|Baseline|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
538304|NCT00824408|B3|Baseline|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
538305|NCT00824408|B2|Baseline|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538306|NCT00824408|B1|Baseline|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538307|NCT00824408|P5|Participant Flow|Randomized Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538308|NCT00824408|P4|Participant Flow|Randomized Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously on day 1 of each 21 day cycle
538309|NCT00824408|P3|Participant Flow|Randomized Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle
538310|NCT00824408|P2|Participant Flow|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538311|NCT00824408|P1|Participant Flow|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538312|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538313|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538314|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538457|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
538315|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538316|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538317|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538318|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
538319|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538320|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538321|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
538322|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538323|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538324|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
538325|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538326|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538327|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538328|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
538329|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
538330|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538331|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538332|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538333|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538334|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538335|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
538336|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
538337|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538338|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538339|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538340|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
538341|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
538342|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538343|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
538344|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
538345|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538346|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
538347|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
538348|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538349|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538350|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538351|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
538352|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
538353|NCT00824408|E5|Reported Event|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538354|NCT00824408|E4|Reported Event|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
538355|NCT00824408|E3|Reported Event|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
538356|NCT00824408|E2|Reported Event|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
538357|NCT00824408|E1|Reported Event|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
538358|NCT00824421|B4|Baseline|Total|Total of all reporting groups
538359|NCT00824421|B3|Baseline|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538360|NCT00824421|B2|Baseline|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538361|NCT00824421|B1|Baseline|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538362|NCT00824421|P3|Participant Flow|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538363|NCT00824421|P2|Participant Flow|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538364|NCT00824421|P1|Participant Flow|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538365|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
538366|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
538367|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
538458|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
538459|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
538460|NCT00824460|O5|Outcome|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
538368|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
538369|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
538370|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
538371|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
538372|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
538373|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538374|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538375|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538376|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538377|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538378|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538379|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538461|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
538380|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538381|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538382|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538383|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538384|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538385|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538386|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538387|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538388|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538389|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538390|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538391|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538392|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538393|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538394|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538395|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538396|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538397|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538398|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538462|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
538463|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
538464|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
538465|NCT00824460|E6|Reported Event|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
538466|NCT00824460|E5|Reported Event|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
538467|NCT00824460|E4|Reported Event|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
538399|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538400|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538401|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538402|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538403|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538404|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538405|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538406|NCT00824421|E3|Reported Event|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538407|NCT00824421|E2|Reported Event|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538468|NCT00824460|E3|Reported Event|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
538469|NCT00824460|E2|Reported Event|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
538470|NCT00824460|E1|Reported Event|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
538471|NCT00824473|B3|Baseline|Total|Total of all reporting groups
538472|NCT00824473|B2|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
538473|NCT00824473|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
538408|NCT00824421|E1|Reported Event|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
538409|NCT00824434|B1|Baseline|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538410|NCT00824434|P1|Participant Flow|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538411|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538412|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538413|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538414|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538415|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538416|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538417|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538418|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538419|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538420|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538421|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538422|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538423|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538424|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538425|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538426|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538427|NCT00824434|E1|Reported Event|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
538428|NCT00824460|B7|Baseline|Total|Total of all reporting groups
538429|NCT00824460|B6|Baseline|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
538430|NCT00824460|B5|Baseline|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
538431|NCT00824460|B4|Baseline|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0g PA21 (8 tablets)
538432|NCT00824460|B3|Baseline|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
538433|NCT00824460|B2|Baseline|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
538434|NCT00824460|B1|Baseline|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
538435|NCT00824460|P6|Participant Flow|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
538436|NCT00824460|P5|Participant Flow|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
538437|NCT00824460|P4|Participant Flow|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
538438|NCT00824460|P3|Participant Flow|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
538439|NCT00824460|P2|Participant Flow|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
538440|NCT00824460|P1|Participant Flow|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
538441|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
538442|NCT00824460|O5|Outcome|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
538443|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
538444|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
538445|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
538446|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
538447|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8g sevelamer hydrochloride (6 tablets)
538448|NCT00824460|O5|Outcome|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5g PA21 (10 tablets)
538449|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0g PA21 (8 tablets)
538450|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5g PA21 (6 tablets)
538451|NCT00824460|O2|Outcome|5.0g PA21 (1,000 mg Iron)|Daily dose of 5.0g PA21 (4 tablets)
538452|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25g PA21 (1 tablet)
538453|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
538454|NCT00824460|O5|Outcome|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
538455|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
538456|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
538474|NCT00824473|P2|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
538475|NCT00824473|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
538476|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
538477|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
538478|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
538479|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
538480|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
538481|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
538482|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
538483|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
538484|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
538485|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
538486|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
538487|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
538488|NCT00824473|E2|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
538489|NCT00824473|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
538490|NCT00824512|B3|Baseline|Total|Total of all reporting groups
538491|NCT00824512|B2|Baseline|Placebo|"Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed."
538492|NCT00824512|B1|Baseline|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538493|NCT00824512|P2|Participant Flow|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538494|NCT00824512|P1|Participant Flow|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538495|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538496|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538497|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538498|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538499|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538500|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538501|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538502|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538503|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538504|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538505|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538506|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538507|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538508|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538509|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538510|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538511|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538512|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538513|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538514|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538515|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538516|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538517|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538518|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538519|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538520|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538521|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538522|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538523|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538524|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538525|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538526|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538527|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538528|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538529|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538530|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538531|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538532|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538533|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538534|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538535|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538536|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538537|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
538538|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538539|NCT00824512|E2|Reported Event|Placebo|"Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed."
538540|NCT00824512|E1|Reported Event|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
538541|NCT00824538|B1|Baseline|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
538542|NCT00824538|P1|Participant Flow|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
538543|NCT00824538|O1|Outcome|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
538544|NCT00824538|O1|Outcome|Sunitinib|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
538545|NCT00824538|O1|Outcome|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
538546|NCT00824538|E1|Reported Event|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
538547|NCT00824564|B3|Baseline|Total|Total of all reporting groups
538548|NCT00824564|B2|Baseline|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
538549|NCT00824564|B1|Baseline|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
538550|NCT00824564|P2|Participant Flow|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
538551|NCT00824564|P1|Participant Flow|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
538552|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
538553|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
538554|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
538555|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
538556|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
538557|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
538558|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
538559|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
538560|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
538561|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
539256|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
538562|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
538563|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
538564|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
538565|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
538566|NCT00824564|E2|Reported Event|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
538567|NCT00824564|E1|Reported Event|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
538568|NCT00824616|B3|Baseline|Total|Total of all reporting groups
538569|NCT00824616|B2|Baseline|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
538570|NCT00824616|B1|Baseline|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
538571|NCT00824616|P2|Participant Flow|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
538572|NCT00824616|P1|Participant Flow|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
538573|NCT00824616|O2|Outcome|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
538574|NCT00824616|O1|Outcome|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
538575|NCT00824616|O2|Outcome|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
538576|NCT00824616|O1|Outcome|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
538577|NCT00824616|E2|Reported Event|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
538578|NCT00824616|E1|Reported Event|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
538579|NCT00824655|B3|Baseline|Total|Total of all reporting groups
538580|NCT00824655|B2|Baseline|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
538581|NCT00824655|B1|Baseline|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
538582|NCT00824655|P2|Participant Flow|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants had received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
538583|NCT00824655|P1|Participant Flow|13vPnC/13vPnC|Participants received two doses of 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7-valent pneumococcal conjugate vaccine (7vPnC), at approximately 3 months of age prior to enrollment in the study.
538584|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
538585|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
538586|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
538587|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
538588|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
538589|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
538590|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
538591|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
538592|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
538675|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538593|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
538594|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
538595|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
538596|NCT00824655|E4|Reported Event|13vPnC at 12 Months|13vPnC 0.5 mL dose administered IM at 12 months of age (toddler dose).
538597|NCT00824655|E3|Reported Event|13vPnC/13vPnC at 12 Months|13vPnC 0.5 mL dose administered IM at 5 months (infant dose) and 12 months of age (toddler dose).
538598|NCT00824655|E2|Reported Event|13vPnC/13vPnC at 6 Months of Age|13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose); assessment 1 month after the infant series (6 months of age).
538599|NCT00824655|E1|Reported Event|13vPnC/13vPnC at 5 Months|13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose)
538600|NCT00824720|B4|Baseline|Total|Total of all reporting groups
538601|NCT00824720|B3|Baseline|Placebo|punctal plug without bimatoprost
538602|NCT00824720|B2|Baseline|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
538603|NCT00824720|B1|Baseline|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
538604|NCT00824720|P3|Participant Flow|Placebo|punctal plug without bimatoprost
538605|NCT00824720|P2|Participant Flow|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
538606|NCT00824720|P1|Participant Flow|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
538607|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
538608|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
538609|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
538610|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
538611|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
538612|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
538613|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
538614|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
538615|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
538616|NCT00824720|E3|Reported Event|Placebo|punctal plug without bimatoprost
538617|NCT00824720|E2|Reported Event|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
538618|NCT00824720|E1|Reported Event|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
538619|NCT00824733|B1|Baseline|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.
Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
538620|NCT00824733|P1|Participant Flow|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.
Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
538621|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.
Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
538639|NCT00824824|P2|Participant Flow|Brimonidine-Timolol Then Dorzolamide-Timolol|3 of the 7 POAG RVD subjects were ransomized into the brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution. The 3 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 3 subjects were treated with dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution for 6 weeks.After this second 6 week treatment period the same measurements where taken again.
538676|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
539025|NCT00825812|O1|Outcome|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
538622|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.
Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
538623|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.
Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
538624|NCT00824733|E1|Reported Event|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.
Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
538625|NCT00824746|B1|Baseline|Single Arm|Gefitinib retreatment
538626|NCT00824746|P1|Participant Flow|Gefitinib Retreatment Group|Gefitinib retreatment group Patients who were previously treated with gefitinib followed by at least one line of cytotoxic chemotherapy can be enrolled to this retreatment group.
538627|NCT00824746|O1|Outcome|Single Arm|Gefitinib retreatment
538628|NCT00824746|O1|Outcome|Gefitinib Retreatment Group|Gefitinib retreatment
538629|NCT00824746|O1|Outcome|Gefitinib Retreatment Arm|Gefitinib retreatment arm
538630|NCT00824746|E1|Reported Event|Single Arm|Gefitinib retreatment
538631|NCT00824772|B1|Baseline|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:
19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia
Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
538632|NCT00824772|P1|Participant Flow|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:
19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia
Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
538633|NCT00824772|O1|Outcome|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:
19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia
Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
538634|NCT00824772|O1|Outcome|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:
19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia
Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
538635|NCT00824772|E1|Reported Event|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:
19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia
Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
538636|NCT00824824|B3|Baseline|Total|Total of all reporting groups
538637|NCT00824824|B2|Baseline|POAG With RVD|7 subjects with POAG were identified to have retinal vascular dysregulation (RVD). We determined whether RVD was present in the following way. The percentage change between the retinal blood flow measured while reclining for 30 min and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the retinal blood flow while reclining compared to sitting was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ±2 standard deviations about the mean percentage change found in the control group in our previous study. Subjects with a change in retinal blood flow induced by posture change outside of -17.5% to +35.5% where considered to have RVD.
538638|NCT00824824|B1|Baseline|Primary Open Angle Glaucoma|Subjects of either gender with age range 40 to 80 years old with POAG were eligible for the study. Eligible subjects had a history of an untreated IOP > 21 mmHg in the left eye and a CPSD ≥ 1.0 in this eye. Patients being treated with more than two IOP lowering medications concurrently were excluded. All eligible subjects had open angles on gonioscopy with the filtering portion of the trabecular meshwork visible for 360° in both eyes. All subjects also had at least two reliable Humphrey 24-2 full threshold visual fields that showed reproducible loss in the left eye on tests with fixation loss ≤33%, false positives ≤ 20% and false negatives ≤ 20%. Patients with evidence of exfoliation or pigment dispersion syndrome in either eye were excluded. Subjects with diabetic retinopathy or a history of ocular laser or incisional surgery in either eye were also excluded.
539125|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
538640|NCT00824824|P1|Participant Flow|Dorzolamide-Timolol Then Brimonidine-Timolol|4 of the 7 POAG subjects with RVD were randomized into the dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution. The 4 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 4 subjects were treated with brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution for 6 weeks. After this second 6 week period the same measurements that were taken previously were taken again.
538641|NCT00824824|O2|Outcome|Brimonidine-Timolol|Post timolol-brimonidine outcome: 6 of the 7 patients were tested following timolol-brimonidine. One of the 7 patients could not be tested due to technical issues. Of the 6 that were tested, 4 patients had retinal vascular autoregulation that was in the normal range. Two patients continued to show RVD.
538642|NCT00824824|O1|Outcome|Dorzolamide-Timolol|Post timolol-dorzolamide outcome: All 7 patients who had RVD following timolol had retinal vascular autoregulation that was in the normal range.
538643|NCT00824824|E2|Reported Event|Brimonidine-Timolol Then Dorzolamide-Timolol|3 of the 7 POAG RVD subjects were ransomized into the brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution. The 3 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 3 subjects were treated with dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution for 6 weeks.After this second 6 week treatment period the same measurements where taken again.
538644|NCT00824824|E1|Reported Event|Dorzolamide-Timolol Then Brimonidine-Timolol|4 of the 7 POAG subjects with RVD were randomized into the dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution. The 4 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 4 subjects were treated with brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution for 6 weeks. After this second 6 week period the same measurements that were taken previously were taken again.
538645|NCT00824850|B3|Baseline|Total|Total of all reporting groups
538646|NCT00824850|B2|Baseline|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538647|NCT00824850|B1|Baseline|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538648|NCT00824850|P2|Participant Flow|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538649|NCT00824850|P1|Participant Flow|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538650|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538651|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538652|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538653|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538654|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538655|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538656|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538657|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538658|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538659|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538660|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538661|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538662|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538663|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538664|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538665|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538666|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538667|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538668|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538669|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538670|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538671|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538672|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538673|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538674|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
539364|NCT00827372|O1|Outcome|Overall|All patients who were treated
538677|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538678|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538679|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538680|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538681|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538682|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538683|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538684|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538685|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538686|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538687|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538688|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
538689|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
538690|NCT00824850|E2|Reported Event|MnCC / 13vPnC|"13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).
Other Adverse Events N=20; Local reactions N=36; Systemic events N=36."
538691|NCT00824850|E1|Reported Event|7vPnC / 13vPnC|"13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).
Other Adverse Events N=22; Local reactions N=38; Systemic events N=38."
538692|NCT00817999|B3|Baseline|Total|Total of all reporting groups
538693|NCT00817999|B2|Baseline|Maintenance Dose|
538694|NCT00817999|B1|Baseline|Loading Dose|
538695|NCT00817999|P2|Participant Flow|Maintenance Dose|Healthy volunteers who received clopidogrel 75 mg/day for 7 days during each period with or without grapefruit juice.
538696|NCT00817999|P1|Participant Flow|Loading Dose|Healthy volunteers who received a 300 mg dose of clopidogrel with or without grapefruit juice.
538697|NCT00817999|O4|Outcome|Maintenance Dose Without Grapefruit Juice|
538698|NCT00817999|O3|Outcome|Loading Dose Without Grapefruit Juice|
538699|NCT00817999|O2|Outcome|Maintenance Dose With Grapefruit Juice|
538700|NCT00817999|O1|Outcome|Loading Dose With Grapefruit Juice|
538701|NCT00817999|E2|Reported Event|Maintenance Dose|
538702|NCT00817999|E1|Reported Event|Loading Dose|
538703|NCT00818116|B1|Baseline|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
538704|NCT00818116|P1|Participant Flow|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
538705|NCT00818116|O1|Outcome|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
538706|NCT00818116|E1|Reported Event|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
538707|NCT00818168|B1|Baseline|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
538708|NCT00818168|P1|Participant Flow|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
538709|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
538710|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
538711|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
538712|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
538713|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
538714|NCT00818168|E1|Reported Event|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
538715|NCT00818207|B3|Baseline|Total|Total of all reporting groups
538716|NCT00818207|B2|Baseline|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
538740|NCT00818259|B7|Baseline|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538717|NCT00818207|B1|Baseline|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
538718|NCT00818207|P2|Participant Flow|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
538719|NCT00818207|P1|Participant Flow|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
538720|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
538721|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
538722|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
538723|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
538724|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
538725|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
538726|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
538727|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
538728|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
538729|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
538730|NCT00818207|E2|Reported Event|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
538731|NCT00818207|E1|Reported Event|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
538732|NCT00818246|B1|Baseline|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
538733|NCT00818246|P1|Participant Flow|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
538734|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
538735|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
538736|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
538737|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
538738|NCT00818246|E1|Reported Event|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
538739|NCT00818259|B8|Baseline|Total|Total of all reporting groups
538741|NCT00818259|B6|Baseline|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538742|NCT00818259|B5|Baseline|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538743|NCT00818259|B4|Baseline|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538744|NCT00818259|B3|Baseline|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538745|NCT00818259|B2|Baseline|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538746|NCT00818259|B1|Baseline|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538747|NCT00818259|P9|Participant Flow|Part V-Additional Enrollers|Additional participants were enrolled in Part V. Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538748|NCT00818259|P8|Participant Flow|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538749|NCT00818259|P7|Participant Flow|Part IV-Additional Enrollers|Additional participants were enrolled in Part IV. Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538750|NCT00818259|P6|Participant Flow|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538751|NCT00818259|P5|Participant Flow|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538752|NCT00818259|P4|Participant Flow|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538753|NCT00818259|P3|Participant Flow|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538754|NCT00818259|P2|Participant Flow|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538755|NCT00818259|P1|Participant Flow|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538756|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538757|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
539126|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
539127|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
538758|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538759|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538760|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538761|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538762|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538763|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538764|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538765|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538766|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538767|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538768|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538769|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538770|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538771|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538772|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538773|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538774|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538775|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538776|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
539128|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
539129|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
538777|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538778|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538779|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538780|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538781|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538782|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538783|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538784|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538785|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538786|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538787|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538788|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538789|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538790|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538791|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538792|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538793|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538794|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538814|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538795|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538796|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538797|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538798|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538799|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538800|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538801|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538802|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538803|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538804|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538805|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538806|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538807|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538808|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538809|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538810|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538811|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538812|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538813|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538815|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538816|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538817|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538818|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538819|NCT00818259|E7|Reported Event|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538820|NCT00818259|E6|Reported Event|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
538821|NCT00818259|E5|Reported Event|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
538822|NCT00818259|E4|Reported Event|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538823|NCT00818259|E3|Reported Event|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538824|NCT00818259|E2|Reported Event|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538825|NCT00818259|E1|Reported Event|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
538826|NCT00818272|B1|Baseline|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
538827|NCT00818272|P1|Participant Flow|Infliximab|Participants with confirmed diagnosis of severe active Crohn's disease (CD) and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
538828|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
538829|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
538830|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
538928|NCT00825162|O2|Outcome|After Second Vaccination, Cohort A|Participants aged 6 months to less than 3 years
538831|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
538832|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
538833|NCT00818272|E1|Reported Event|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
538834|NCT00818324|B1|Baseline|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
538835|NCT00818324|P1|Participant Flow|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
538836|NCT00818324|O1|Outcome|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
538837|NCT00818324|O1|Outcome|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
538838|NCT00818324|E1|Reported Event|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
538839|NCT00818337|B1|Baseline|Aspirin 81mg|Aspirin 81mg at baseline
538840|NCT00818337|P1|Participant Flow|Aspirin 81mg|Aspirin 81mg at baseline
538841|NCT00818337|O1|Outcome|Aspirin 325 mg|Participants who were aspirin resistant who were increased to aspirin 325 mg
538842|NCT00818337|O1|Outcome|Aspirin 81 mg|Aspirin 81 mg at baseline
538843|NCT00818337|E1|Reported Event|Aspirin 81mg|Aspirin 81mg at baseline
538844|NCT00818389|B3|Baseline|Total|Total of all reporting groups
538845|NCT00818389|B2|Baseline|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
538846|NCT00818389|B1|Baseline|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
538847|NCT00818389|P2|Participant Flow|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
538848|NCT00818389|P1|Participant Flow|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
538849|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
538850|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
538851|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
539130|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
538852|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
538853|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
538854|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
538855|NCT00818389|E2|Reported Event|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
538856|NCT00818389|E1|Reported Event|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
538857|NCT00818441|B3|Baseline|Total|Total of all reporting groups
538858|NCT00818441|B2|Baseline|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
538859|NCT00818441|B1|Baseline|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
538860|NCT00818441|P2|Participant Flow|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
538861|NCT00818441|P1|Participant Flow|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
538929|NCT00825162|O1|Outcome|After First Vaccination, Cohort A|Participants aged 6 months to less than 3 years
538930|NCT00825162|O3|Outcome|Cohort C|
538931|NCT00825162|O2|Outcome|Cohort B|
538932|NCT00825162|O1|Outcome|Cohort A|
538933|NCT00825162|O2|Outcome|After Second Vaccination, Cohort A|Participants aged 6 months to less than 3 years
538934|NCT00825162|O1|Outcome|After First Vaccination, Cohort A|Participants aged 6 months to less than 3 years
539365|NCT00827372|O1|Outcome|Overall|All patients who were treated
538862|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
538863|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
538864|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
538865|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
538866|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
538867|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
538868|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
538869|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
538968|NCT00825630|E1|Reported Event|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
538870|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
538871|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
538872|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
538873|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
538874|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
538875|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
538876|NCT00818441|O1|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
538877|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
538969|NCT00825682|B3|Baseline|Total|Total of all reporting groups
539366|NCT00827372|O1|Outcome|Overall|All patients who were treated
538878|NCT00818441|E2|Reported Event|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
538879|NCT00818441|E1|Reported Event|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
538880|NCT00818454|B1|Baseline|Entire Study Population|Participants randomized to crossover part at randomization 1
538881|NCT00818454|P4|Participant Flow|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
538882|NCT00818454|P3|Participant Flow|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
538883|NCT00818454|P2|Participant Flow|Combivent CFC First, Then Albuterol HFA|Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
538884|NCT00818454|P1|Participant Flow|Albuterol HFA First, Then Combivent CFC|Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
538885|NCT00818454|O2|Outcome|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
538886|NCT00818454|O1|Outcome|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
538887|NCT00818454|O2|Outcome|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
538888|NCT00818454|O1|Outcome|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
538889|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
538890|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
538891|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
538892|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
538893|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
538894|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
538895|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
538896|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
538897|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
538898|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
538899|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
538900|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
538901|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
538902|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
538903|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
538904|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
538905|NCT00818454|E4|Reported Event|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
538906|NCT00818454|E3|Reported Event|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
538907|NCT00818454|E2|Reported Event|Combivent CFC First, Then Albuterol HFA|Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
538908|NCT00818454|E1|Reported Event|Albuterol HFA First, Then Combivent CFC|Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
538909|NCT00825162|B4|Baseline|Total|Total of all reporting groups
538910|NCT00825162|B3|Baseline|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
538911|NCT00825162|B2|Baseline|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
538912|NCT00825162|B1|Baseline|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
538913|NCT00825162|P3|Participant Flow|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
538914|NCT00825162|P2|Participant Flow|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
538915|NCT00825162|P1|Participant Flow|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
538916|NCT00825162|O3|Outcome|Cohort C|
538917|NCT00825162|O2|Outcome|Cohort B|
538918|NCT00825162|O1|Outcome|Cohort A|
538919|NCT00825162|O3|Outcome|Cohort C|
538920|NCT00825162|O2|Outcome|Cohort B|
538921|NCT00825162|O1|Outcome|Cohort A|
538922|NCT00825162|O1|Outcome|Cohort C|Participants aged 9 to less than 18 years
538923|NCT00825162|O1|Outcome|Cohort C|Participants aged 9 to less than 18 years
538924|NCT00825162|O2|Outcome|After Second Vaccination, Cohort B|Participants aged 3 Years to Less Than 9 Years
538925|NCT00825162|O1|Outcome|After First Vaccination, Cohort B|Participants aged 3 to less than 9 years
538926|NCT00825162|O2|Outcome|After Second Vaccination, Cohort B|Participants aged 3 Years to Less Than 9 Years
538927|NCT00825162|O1|Outcome|After First Vaccination, Cohort B|Participants aged 3 to less than 9 years
538935|NCT00825162|E3|Reported Event|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
538936|NCT00825162|E2|Reported Event|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
538937|NCT00825162|E1|Reported Event|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
538938|NCT00825175|B3|Baseline|Total|Total of all reporting groups
538939|NCT00825175|B2|Baseline|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
538940|NCT00825175|B1|Baseline|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
538941|NCT00825175|P2|Participant Flow|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
538942|NCT00825175|P1|Participant Flow|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
538943|NCT00825175|O2|Outcome|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
538944|NCT00825175|O1|Outcome|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
538945|NCT00825175|E2|Reported Event|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
538946|NCT00825175|E1|Reported Event|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
538947|NCT00825565|B1|Baseline|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
538948|NCT00825565|P1|Participant Flow|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
538949|NCT00825565|O1|Outcome|Allantoin 3% Cream|Subjects were instructed to apply allantoin 3% cream once daily to the target lesion area for assessing the impact on target wound closure.
538950|NCT00825565|O1|Outcome|Allantoin 3% Cream|Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
538951|NCT00825565|E1|Reported Event|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
538952|NCT00825630|B5|Baseline|Total|Total of all reporting groups
538953|NCT00825630|B4|Baseline|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
538954|NCT00825630|B3|Baseline|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
538955|NCT00825630|B2|Baseline|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
538956|NCT00825630|B1|Baseline|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
538957|NCT00825630|P4|Participant Flow|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
538958|NCT00825630|P3|Participant Flow|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
538959|NCT00825630|P2|Participant Flow|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
538960|NCT00825630|P1|Participant Flow|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
538961|NCT00825630|O4|Outcome|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
538962|NCT00825630|O3|Outcome|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
538963|NCT00825630|O2|Outcome|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
538964|NCT00825630|O1|Outcome|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
538965|NCT00825630|E4|Reported Event|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
538966|NCT00825630|E3|Reported Event|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
538967|NCT00825630|E2|Reported Event|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
539131|NCT00826111|O2|Outcome|Placebo|Open label escitalopram for 10 weeks together with placebo for 10 weeks.
538970|NCT00825682|B2|Baseline|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
538971|NCT00825682|B1|Baseline|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
538972|NCT00825682|P2|Participant Flow|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
538973|NCT00825682|P1|Participant Flow|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
538974|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
538975|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
538976|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
538977|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks. Five women did not begin the study and 8 women did not complete reflexology treatments due to personal reasons / inconvenience
538978|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
538979|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
538980|NCT00825682|E2|Reported Event|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
538981|NCT00825682|E1|Reported Event|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
538982|NCT00825734|B1|Baseline|All Patients|"Patients treated at all dose levels in the Phase I and Phase II portions of the study
: Dose Level 1 (4 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)
Dose Level -1 (3 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)
Dose Level 1a (76 patients) Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)"
538983|NCT00825734|P3|Participant Flow|Dose Level 1a|Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)
538984|NCT00825734|P2|Participant Flow|Dose Level -1|Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)
538985|NCT00825734|P1|Participant Flow|Dose Level 1|Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)
538986|NCT00825734|O1|Outcome|Phase II - Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
538987|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
538988|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
538989|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
538990|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
538991|NCT00825734|E1|Reported Event|Dose Level 1a|Includes patients treated at the Phase II dose - Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)
538992|NCT00825786|B3|Baseline|Total|Total of all reporting groups
538993|NCT00825786|B2|Baseline|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
538994|NCT00825786|B1|Baseline|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
538995|NCT00825786|P2|Participant Flow|Control|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
538996|NCT00825786|P1|Participant Flow|Treatment|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
538997|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
538998|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
538999|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539000|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539001|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539002|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539003|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539004|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539005|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539006|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539007|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539008|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539009|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539010|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539011|NCT00825786|E2|Reported Event|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539012|NCT00825786|E1|Reported Event|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
Ropivacaine: ropivacaine (15 ml).
Mepivacaine: One syringe will contain mepivacaine (15 ml)"
539013|NCT00825812|B5|Baseline|Total|Total of all reporting groups
539014|NCT00825812|B4|Baseline|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
539015|NCT00825812|B3|Baseline|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
539016|NCT00825812|B2|Baseline|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
539017|NCT00825812|B1|Baseline|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
539018|NCT00825812|P4|Participant Flow|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
539019|NCT00825812|P3|Participant Flow|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
539020|NCT00825812|P2|Participant Flow|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
539021|NCT00825812|P1|Participant Flow|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
539022|NCT00825812|O4|Outcome|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
539023|NCT00825812|O3|Outcome|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
539024|NCT00825812|O2|Outcome|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
539026|NCT00825812|O4|Outcome|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
539027|NCT00825812|O3|Outcome|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
539028|NCT00825812|O2|Outcome|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
539029|NCT00825812|O1|Outcome|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
539030|NCT00825812|E4|Reported Event|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
539031|NCT00825812|E3|Reported Event|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
539032|NCT00825812|E2|Reported Event|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
539033|NCT00825812|E1|Reported Event|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
539034|NCT00825825|B1|Baseline|Entire Study Population|Includes all randomized subjects regardless of order in which they received medications
539035|NCT00825825|P6|Participant Flow|Placebo First / Citalopram Second / Escitalopram Third|2 weeks of placebo followed by 2 weeks of citalopram followed by 2 weeks escitalopram
539036|NCT00825825|P5|Participant Flow|Placebo First / Escitalopram Second / Citalopram Third|2 weeks of placebo followed by 2 weeks of escitalopram followed by 2 weeks of citalopram
539037|NCT00825825|P4|Participant Flow|Citalopram First / Placebo Second / Escitalopram Third|2 weeks of citalopram followed by 2 weeks of placebo followed by 2 weeks of escitalopram
539038|NCT00825825|P3|Participant Flow|Citalopram First / Escitalopram Second / Placebo Third|2 weeks of citalopram followed by 2 weeks of escitalopram followed by 2 weeks of placebo
539039|NCT00825825|P2|Participant Flow|Escitalopram First / Placebo Second / Citalopram Third|2 weeks of escitalopram followed by 2 weeks of placebo followed by 2 weeks of citalopram
539040|NCT00825825|P1|Participant Flow|Escitalopram First / Citalopram Second / Placebo Third|2 weeks of escitalopram followed by 2 weeks of citalopram followed by 2 weeks of placebo
539041|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
539042|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
539043|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
539044|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
539045|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
539046|NCT00825825|O1|Outcome|All Participants With Complete Usuable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
539047|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
539048|NCT00825825|E3|Reported Event|Placebo|Includes all subjects who received placebo in one of the three medication periods
539049|NCT00825825|E2|Reported Event|Citalopram|Includes all subjects who received citalopram in one of the three medication periods
539050|NCT00825825|E1|Reported Event|Escitalopram|Includes all subjects who received escitalopram in one of the three medication periods
539051|NCT00825916|B4|Baseline|Total|Total of all reporting groups
539052|NCT00825916|B3|Baseline|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539053|NCT00825916|B2|Baseline|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539054|NCT00825916|B1|Baseline|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539055|NCT00825916|P3|Participant Flow|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539056|NCT00825916|P2|Participant Flow|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539367|NCT00827372|O1|Outcome|Overall Study|All patients who were treated
539057|NCT00825916|P1|Participant Flow|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539058|NCT00825916|O9|Outcome|Scar Total Volume - 10 mg AZX100|This group included Month 12 scar total volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539059|NCT00825916|O8|Outcome|Scar Total Volume - 3 mg AZX100|This group included Month 12 scar total volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539060|NCT00825916|O7|Outcome|Scar Total Volume - Placebo|This group included Month 12 scar total volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539061|NCT00825916|O6|Outcome|Scar Negative Volume - 10 mg AZX100|This group included Month 12 scar negative volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539062|NCT00825916|O5|Outcome|Scar Negative Volume - 3 mg AZX100|This group included Month 12 scar negative volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539063|NCT00825916|O4|Outcome|Scar Negative Volume - Placebo|This group included Month 12 scar negative volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539064|NCT00825916|O3|Outcome|Scar Positive Volume - 10 mg AZX100|This group included Month 12 scar positive volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539065|NCT00825916|O2|Outcome|Scar Positive Volume - 3 mg AZX100|This group included Month 12 scar positive volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539066|NCT00825916|O1|Outcome|Scar Positive Volume - Placebo|This group included Month 12 scar positive volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539067|NCT00825916|O15|Outcome|Scar Mean Elevation - 10 mg AZX100|This group included Month 12 scar mean elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539068|NCT00825916|O14|Outcome|Scar Mean Elevation - 3 mg AZX100|This group included Month 12 scar mean elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539069|NCT00825916|O13|Outcome|Scar Mean Elevation - Placebo|This group included Month 12 scar mean elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539070|NCT00825916|O12|Outcome|Scar Maximum Elevation - 10 mg AZX100|This group included Month 12 scar maximum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539071|NCT00825916|O11|Outcome|Scar Maximum Elevation - 3 mg AZX100|This group included Month 12 scar maximum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539072|NCT00825916|O10|Outcome|Scar Maximum Elevation - Placebo|This group included Month 12 scar maximum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539073|NCT00825916|O9|Outcome|Scar Minimum Elevation - 10 mg AZX100|This group included Month 12 scar minimum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539074|NCT00825916|O8|Outcome|Scar Minimum Elevation - 3 mg AZX100|This group included Month 12 scar minimum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539075|NCT00825916|O7|Outcome|Scar Minimum Elevation - Placebo|This group included Month 12 scar minimum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539076|NCT00825916|O6|Outcome|Scar Width - 10 mg AZX100|This group included Month 12 scar width (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539077|NCT00825916|O5|Outcome|Scar Width - 3 mg AZX100|This group included Month 12 scar width (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539078|NCT00825916|O4|Outcome|Scar Width - Placebo|This group included Month 12 scar width (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539079|NCT00825916|O3|Outcome|Scar Length - 10 mg AZX100|This group included Month 12 scar length (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539080|NCT00825916|O2|Outcome|Scar Length - 3 mg AZX100|This group included Month 12 scar length (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539081|NCT00825916|O1|Outcome|Scar Length - Placebo|This group included Month 12 scar length (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539082|NCT00825916|O6|Outcome|Rater 2 VAS Scores for 10 mg AZX100|This group included Month 12 VAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539083|NCT00825916|O5|Outcome|Rater 2 VAS Scores for 3 mg AZX100|This group included Month 12 VAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539084|NCT00825916|O4|Outcome|Rater 2 VAS Scores for Placebo|This group included Month 12 VAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539085|NCT00825916|O3|Outcome|Rater 1 VAS Scores for 10 mg AZX100|This group included Month 12 VAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539086|NCT00825916|O2|Outcome|Rater 1 VAS Scores for 3 mg AZX100|This group included Month 12 VAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539087|NCT00825916|O1|Outcome|Rater 1 VAS Scores for Placebo|This group included Month 12 VAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539088|NCT00825916|O6|Outcome|OSAS Results for 10 mg AZX100|This group included Month 12 OSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539089|NCT00825916|O5|Outcome|OSAS Results for 3 mg AZX100|This group included Month 12 OSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539090|NCT00825916|O4|Outcome|OSAS Results for Placebo|This group included Month 12 OSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539091|NCT00825916|O3|Outcome|PSAS Results for 10 mg AZX100|This group included Month 12 PSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539092|NCT00825916|O2|Outcome|PSAS Results for 3 mg AZX100|This group included Month 12 PSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539093|NCT00825916|O1|Outcome|PSAS Results for Placebo|This group included Month 12 PSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539094|NCT00825916|E3|Reported Event|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539095|NCT00825916|E2|Reported Event|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539096|NCT00825916|E1|Reported Event|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
539097|NCT00825994|B1|Baseline|Omega-3|omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
539098|NCT00825994|P1|Participant Flow|Omega-3|omega-3 fatty acids, 2g qd [every day] (2 x 1 gram tablets), PO [by mouth]
539099|NCT00825994|O1|Outcome|Omega-3 Fatty Acids|We conducted an open label study of omega-3 fatty acids for the treatment of major depressive disorder (MDD) in women who were perimenopausal or postmenopausal.
539100|NCT00825994|O1|Outcome|Omega-3 Fatty Acids|We conducted an open label study of omega-3 fatty acids for the treatment of major depressive disorder (MDD) in women who were perimenopausal or postmenopausal.
539101|NCT00825994|E1|Reported Event|Omega-3|omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
539102|NCT00826007|B3|Baseline|Total|Total of all reporting groups
539103|NCT00826007|B2|Baseline|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
539104|NCT00826007|B1|Baseline|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
539105|NCT00826007|P2|Participant Flow|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
539106|NCT00826007|P1|Participant Flow|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
539107|NCT00826007|O2|Outcome|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
539108|NCT00826007|O1|Outcome|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
539109|NCT00826007|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
539110|NCT00826111|B3|Baseline|Total|Total of all reporting groups
539111|NCT00826111|B2|Baseline|Placebo|Escitalopram with placebo
539112|NCT00826111|B1|Baseline|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
539113|NCT00826111|P2|Participant Flow|Placebo|Escitalopram with placebo
539114|NCT00826111|P1|Participant Flow|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
539115|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
539116|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
539117|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
539118|NCT00826111|O1|Outcome|Eszopiclone|Escitalopram for 10 weeks together with eszopiclone.
539119|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
539120|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
539121|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
539122|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
539123|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
539124|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
539132|NCT00826111|O1|Outcome|Eszopiclone|Open label escitalopram for 10 weeks together with 3 mg eszopiclone for eight weeks followed by placebo for two weeks.
539133|NCT00826111|E2|Reported Event|Placebo|Escitalopram with placebo
539134|NCT00826111|E1|Reported Event|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
539135|NCT00826176|B3|Baseline|Total|Total of all reporting groups
539136|NCT00826176|B2|Baseline|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
539137|NCT00826176|B1|Baseline|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
539138|NCT00826176|P2|Participant Flow|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
539139|NCT00826176|P1|Participant Flow|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
539140|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
539141|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
539142|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
539143|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
539144|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
539145|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
539146|NCT00826176|E2|Reported Event|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
539147|NCT00826176|E1|Reported Event|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
539148|NCT00826202|B3|Baseline|Total|Total of all reporting groups
539149|NCT00826202|B2|Baseline|Placebo|Placebo: Inert Placebo
539150|NCT00826202|B1|Baseline|D Serine|"60 mg/kg/day
D-serine: 60 mg/kg/day"
539151|NCT00826202|P2|Participant Flow|Placebo|Placebo: Inert Placebo
539152|NCT00826202|P1|Participant Flow|D Serine|"60 mg/kg/day
D-serine: 60 mg/kg/day"
539153|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
539154|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day
D-serine: 60 mg/kg/day"
539155|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
539156|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day
D-serine: 60 mg/kg/day"
539157|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
539158|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day
D-serine: 60 mg/kg/day"
539159|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
539160|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day
D-serine: 60 mg/kg/day"
539161|NCT00826202|E2|Reported Event|Placebo|Placebo: Inert Placebo
539162|NCT00826202|E1|Reported Event|D Serine|"60 mg/kg/day
D-serine: 60 mg/kg/day"
539163|NCT00826228|B1|Baseline|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
539164|NCT00826228|P1|Participant Flow|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing on a Lokomat
539165|NCT00826228|O1|Outcome|PTH/Weight-Bearing|
539166|NCT00826228|O1|Outcome|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
539167|NCT00826228|E1|Reported Event|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
539168|NCT00826267|B4|Baseline|Total|Total of all reporting groups
539169|NCT00826267|B3|Baseline|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
539170|NCT00826267|B2|Baseline|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539171|NCT00826267|B1|Baseline|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539172|NCT00826267|P3|Participant Flow|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
539173|NCT00826267|P2|Participant Flow|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539174|NCT00826267|P1|Participant Flow|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539175|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
539176|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539177|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539178|NCT00826267|O1|Outcome|Afatinib 50mg|Patients received Afatinib 50 mg at day 7.
539255|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
539179|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
539180|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539181|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539182|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
539183|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539184|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539185|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
539186|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539187|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539188|NCT00826267|E3|Reported Event|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
539189|NCT00826267|E2|Reported Event|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539190|NCT00826267|E1|Reported Event|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
539191|NCT00826280|B4|Baseline|Total|Total of all reporting groups
539192|NCT00826280|B3|Baseline|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539193|NCT00826280|B2|Baseline|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539194|NCT00826280|B1|Baseline|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
539195|NCT00826280|P3|Participant Flow|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539196|NCT00826280|P2|Participant Flow|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539197|NCT00826280|P1|Participant Flow|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
539198|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539199|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539200|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
539201|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539202|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539203|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
539204|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539205|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539206|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
539207|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539208|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539209|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
539210|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539211|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539212|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
539213|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539214|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539215|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
539216|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539217|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539218|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
539219|NCT00826280|E3|Reported Event|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539220|NCT00826280|E2|Reported Event|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
539221|NCT00826280|E1|Reported Event|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
539222|NCT00826449|B3|Baseline|Total|Total of all reporting groups
539223|NCT00826449|B2|Baseline|Dasatinib + Erlotinib: Phase 2|MTD from Phase I Dasatinib orally dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
539224|NCT00826449|B1|Baseline|Dasatinib + Erlotinib: Phase I|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
539225|NCT00826449|P1|Participant Flow|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
539226|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
539227|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
539228|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
539229|NCT00826449|E1|Reported Event|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
539230|NCT00826540|B1|Baseline|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies > > sorafenib tosylate: Given orally >
> bevacizumab: Given IV"
539231|NCT00826540|P1|Participant Flow|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies > > sorafenib tosylate: Given orally >
> bevacizumab: Given IV"
539232|NCT00826540|O1|Outcome|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies >
> sorafenib tosylate: Given orally
>
> bevacizumab: Given IV"
539233|NCT00826540|E1|Reported Event|Treatment (Sorafenib Tosylate and Bevacizumab)|bevacizumab: Given IV
539234|NCT00826618|B1|Baseline|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
539235|NCT00826618|P1|Participant Flow|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
539236|NCT00826618|O1|Outcome|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME. Mean change in BCVA (assessed by the ETDRS chart at 4 m) from baseline at 12 months was 12.2 ETDRS letters (P = 0.015).
539237|NCT00826618|E1|Reported Event|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
539238|NCT00826800|B1|Baseline|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
539239|NCT00826800|P1|Participant Flow|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
539240|NCT00826800|O1|Outcome|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
539241|NCT00826800|E1|Reported Event|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
539242|NCT00826943|B1|Baseline|All Study Participants|Cross Over (all participants received all interventions)
539243|NCT00826943|P6|Participant Flow|C Then P Then L|cetirizine 10 mg daily x 7 days then placebo daily x 7 days then levocetirizine 5 mg daily x 7 days (wash out periods before and after each)
539244|NCT00826943|P5|Participant Flow|C Then L Then P|cetirizine 10 mg daily x 7 days then levocetirizine 5 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
539245|NCT00826943|P4|Participant Flow|P Then C Then L|placebo daily x 7 days then cetirizine 10 mg daily x 7 days then levocetirizine daily x 7 days (wash out periods before and after each)
539246|NCT00826943|P3|Participant Flow|P Then L Then C|placebo daily x 7 days then levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days (wash out periods before and after each)
539247|NCT00826943|P2|Participant Flow|L Then P Then C|Levocetirizine 5 mg daily x 7 days then placebo daily x 7 days then cetiriznie 10 mg daily x 7 days (wash out periods before and after each)
539248|NCT00826943|P1|Participant Flow|L Then C Then P|Levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
539249|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
539250|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
539251|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
539252|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
539253|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
539254|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
539257|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
539258|NCT00826943|E3|Reported Event|Cetirizine|cross over = all participants received all interventions
539259|NCT00826943|E2|Reported Event|Levocetirizine|cross over (all participants received all interventions)
539260|NCT00826943|E1|Reported Event|Placebo|Cross Over (all participants received all interventions)
539261|NCT00827073|B3|Baseline|Total|Total of all reporting groups
539262|NCT00827073|B2|Baseline|Lidocaine 2% Jelly|"betadine: betadine 5%
anesthetic"
539263|NCT00827073|B1|Baseline|Tetracaine 5% Drop|"betadine: betadine 5%
topical anesthetic"
539264|NCT00827073|P2|Participant Flow|Lidocaine 2% Jelly|betadine: betadine 5% Anesthetic: lidocaine 2% jelly
539265|NCT00827073|P1|Participant Flow|Tetracaine 5% Drop|betadine: betadine 5%, topical anesthetic drop
539266|NCT00827073|O2|Outcome|Lidocaine 2% Jelly|"betadine: betadine 5%
Anesthetic"
539267|NCT00827073|O1|Outcome|Tetracaine 0.5% Drop|"betadine: betadine 5%
topical anesthetic"
539268|NCT00827073|O2|Outcome|Lidocaine 2% Jelly|"betadine: betadine 5%
Anesthetic"
539269|NCT00827073|O1|Outcome|Tetracaine 0.5% Drop|"betadine: betadine 5%
topical anesthetic"
539270|NCT00827073|E2|Reported Event|Lidocaine 2% Jelly|"betadine: betadine 5%
Anesthetic"
539271|NCT00827073|E1|Reported Event|Tetracaine 0.5% Drop|"betadine: betadine 5%
Topical Anesthetic"
539272|NCT00827099|B1|Baseline|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3
Melphalan 140 mg^m2 on day -2
Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)
Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.
Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
539273|NCT00827099|P1|Participant Flow|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3
Melphalan 140 mg^m2 on day -2
Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)
Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.
Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
539274|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
539275|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
539276|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
539277|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
539278|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
539279|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
539280|NCT00827099|E1|Reported Event|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3
Melphalan 140 mg^m2 on day -2
Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)
Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.
Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
539281|NCT00827112|B3|Baseline|Total|Total of all reporting groups
539282|NCT00827112|B2|Baseline|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539283|NCT00827112|B1|Baseline|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539284|NCT00827112|P2|Participant Flow|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539285|NCT00827112|P1|Participant Flow|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539286|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539287|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539288|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539289|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539290|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539291|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539292|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539293|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539294|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539295|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539296|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539297|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539298|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539299|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539300|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539301|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539302|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539303|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539304|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539305|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539306|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539307|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539308|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539309|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539310|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539311|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539312|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539313|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539314|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
539315|NCT00827112|E2|Reported Event|Atazanavir / Ritonavir + Emtricitabine/ Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets QD along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
539316|NCT00827112|E1|Reported Event|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir 300 mg or ritonavir 100 mg tablets once daily were orally administered for 96 weeks.
539317|NCT00827242|B3|Baseline|Total|Total of all reporting groups
539318|NCT00827242|B2|Baseline|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539319|NCT00827242|B1|Baseline|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539320|NCT00827242|P2|Participant Flow|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539321|NCT00827242|P1|Participant Flow|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539322|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539323|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539324|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539325|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539326|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539327|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539328|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539329|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539330|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539331|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539332|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539333|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539334|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539335|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539336|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539337|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539338|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539339|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539340|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539341|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539342|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539343|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539344|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539345|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539346|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539347|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539348|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539349|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539350|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539351|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539352|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539353|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539354|NCT00827242|E2|Reported Event|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
539355|NCT00827242|E1|Reported Event|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
539356|NCT00827255|B1|Baseline|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
539357|NCT00827255|P1|Participant Flow|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
539358|NCT00827255|O1|Outcome|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
539359|NCT00827255|O1|Outcome|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
539360|NCT00827255|E1|Reported Event|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
539361|NCT00827372|B1|Baseline|Overall Study|All patients who were treated
539362|NCT00827372|P1|Participant Flow|Overall Study|All patients who were treated
539363|NCT00827372|O1|Outcome|Overall|All patients who were treated
539370|NCT00827502|P1|Participant Flow|Azithromycin|The use and dosage recommendations for Azithromycin took place on the basis of the approved local product document (LPD) and were adjusted solely according to medical and therapeutic necessities. According to the approved LPD, in general a total dose of 30 mg/kg was given as a single daily dose(10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, and then reduced to 5 mg/kg on days 2 to 5). For children with acute otitis media a single dose of 30 mg/kg was recommended. Children with streptococcal pharyngitis were given a single dose of 10 mg/kg or 20 mg/kg for 3 days and did not exceed a daily dose of 500mg. The maximum recommended total dose of Azithromycin in children for any treatment was 1500 mg. Azithromycin tablets were administered only to children weighing more than 45 kg.
539371|NCT00827502|O1|Outcome|Azithromycin|
539372|NCT00827502|O1|Outcome|Azithromycin|
539373|NCT00827502|O1|Outcome|Azithromycin|
539374|NCT00827502|E1|Reported Event|Azithromycin|
539375|NCT00827541|B3|Baseline|Total|Total of all reporting groups
539376|NCT00827541|B2|Baseline|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539377|NCT00827541|B1|Baseline|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539378|NCT00827541|P2|Participant Flow|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539379|NCT00827541|P1|Participant Flow|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539380|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539381|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539382|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539383|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539384|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539385|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539386|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539387|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539388|NCT00827541|E2|Reported Event|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539389|NCT00827541|E1|Reported Event|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
539390|NCT00827567|B1|Baseline|RAD 001|RAD001-10 mg by mouth once everyday
539391|NCT00827567|P1|Participant Flow|RAD 001|RAD001-10 mg by mouth once everyday
539392|NCT00827567|O1|Outcome|RAD 001|RAD001-10 mg by mouth once everyday
539393|NCT00827567|E1|Reported Event|RAD 001|RAD001-10 mg by mouth once everyday
539394|NCT00827606|B3|Baseline|Total|Total of all reporting groups
539395|NCT00827606|B2|Baseline|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539396|NCT00827606|B1|Baseline|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539397|NCT00827606|P2|Participant Flow|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged greater than or equal to (≥) 10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539710|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539398|NCT00827606|P1|Participant Flow|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to less than (<)10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 milligrams per day (mg/day), orally (PO), through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target low-density lipoprotein cholesterol (LDL-C) (<3.35 millimoles per liter [mmol/L]) was not attained.
539399|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539400|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539401|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539402|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539403|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539404|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539405|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539406|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539407|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539408|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539409|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539410|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539411|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539423|NCT00827606|O5|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 5|Participants aged ≥10 to 15 years, at Tanner_Stage 5 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539412|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539413|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539414|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539415|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539416|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539417|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539418|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539419|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539420|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539421|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539422|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539424|NCT00827606|O4|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 4|Participants aged ≥10 to 15 years, at Tanner_Stage 4 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539425|NCT00827606|O3|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 3|Participants aged ≥10 to 15 years, at Tanner_Stage 3 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539426|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 2|Participants aged ≥10 to 15 years, at Tanner_Stage 2 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539427|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Baseline Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539428|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539429|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539430|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539431|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539432|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539433|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539434|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539435|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539436|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539437|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539438|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539439|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539440|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539441|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539577|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
543878|NCT00832416|E3|Reported Event|3: Tramadol Once A Day 300mg|
539442|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539443|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539444|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539445|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539446|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539447|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539448|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539449|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539450|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539451|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539452|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539453|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539454|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539455|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539456|NCT00827606|E2|Reported Event|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539457|NCT00827606|E1|Reported Event|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
539458|NCT00827632|B3|Baseline|Total|Total of all reporting groups
539459|NCT00827632|B2|Baseline|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
539460|NCT00827632|B1|Baseline|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
539461|NCT00827632|P2|Participant Flow|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
539462|NCT00827632|P1|Participant Flow|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
539463|NCT00827632|O2|Outcome|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
539464|NCT00827632|O1|Outcome|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
539465|NCT00827632|E2|Reported Event|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
539466|NCT00827632|E1|Reported Event|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
539467|NCT00827827|B3|Baseline|Total|Total of all reporting groups
543879|NCT00832416|E2|Reported Event|2: Tramadol Once A Day 200mg|
539468|NCT00827827|B2|Baseline|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539469|NCT00827827|B1|Baseline|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539470|NCT00827827|P2|Participant Flow|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539471|NCT00827827|P1|Participant Flow|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539472|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539473|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539474|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539475|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539476|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539477|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539478|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539479|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539480|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539481|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539820|NCT00822354|E2|Reported Event|Placebo|Subjects received placebo every other day for four weeks
539482|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539483|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539484|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539485|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539486|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539487|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539488|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539489|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539490|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539491|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539492|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539493|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539494|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539495|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539914|NCT00828204|B3|Baseline|Total|Total of all reporting groups
539496|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539497|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539498|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539499|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539500|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539501|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539502|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539503|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539504|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539505|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539506|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539507|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539508|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539509|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
540793|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
539510|NCT00827827|E2|Reported Event|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
539511|NCT00827827|E1|Reported Event|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
539512|NCT00827918|B4|Baseline|Total|Total of all reporting groups
539513|NCT00827918|B3|Baseline|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
539514|NCT00827918|B2|Baseline|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
539515|NCT00827918|B1|Baseline|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
539516|NCT00827918|P3|Participant Flow|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
539517|NCT00827918|P2|Participant Flow|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
539518|NCT00827918|P1|Participant Flow|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
539519|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
539520|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
539521|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
539522|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
539523|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
539524|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
539525|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
539526|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
539527|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
539528|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
539529|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
539530|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
539531|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
539532|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
539533|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
539534|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
539535|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
539536|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
539537|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
539538|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
539539|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
539540|NCT00827918|E3|Reported Event|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
539541|NCT00827918|E2|Reported Event|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
539542|NCT00827918|E1|Reported Event|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
539543|NCT00827931|B3|Baseline|Total|Total of all reporting groups
539544|NCT00827931|B2|Baseline|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
539545|NCT00827931|B1|Baseline|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
539546|NCT00827931|P2|Participant Flow|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
539547|NCT00827931|P1|Participant Flow|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
539548|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
539711|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539549|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
539550|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
539551|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
539552|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
539553|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
539554|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
539555|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
539556|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
539557|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
539558|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
539559|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
539560|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
539561|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
539562|NCT00827931|E2|Reported Event|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
539563|NCT00827931|E1|Reported Event|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
539564|NCT00827944|B3|Baseline|Total|Total of all reporting groups
539565|NCT00827944|B2|Baseline|Lichtenstein Group|"Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
539566|NCT00827944|B1|Baseline|Progrip Group|"Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
539567|NCT00827944|P2|Participant Flow|Lichtenstein Group|"Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
539568|NCT00827944|P1|Participant Flow|Progrip Group|"Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
539569|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
539570|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
539571|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
539572|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
539573|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
539574|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
539575|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
539576|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
539578|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
539579|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
539580|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
539581|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
539582|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
539583|NCT00827944|E2|Reported Event|Lichtenstein Group|"Low weight polypropylene mesh
Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
539584|NCT00827944|E1|Reported Event|Progrip Group|"Parietex ProGrip
Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
539585|NCT00827983|B3|Baseline|Total|Total of all reporting groups
539586|NCT00827983|B2|Baseline|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539587|NCT00827983|B1|Baseline|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539588|NCT00827983|P2|Participant Flow|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539589|NCT00827983|P1|Participant Flow|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539590|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539591|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539592|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539593|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539594|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539595|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539596|NCT00827983|E2|Reported Event|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539597|NCT00827983|E1|Reported Event|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
539598|NCT00821431|B3|Baseline|Total|Total of all reporting groups
539599|NCT00821431|B2|Baseline|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.
Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
539600|NCT00821431|B1|Baseline|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.
Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:
Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.
Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
539601|NCT00821431|P2|Participant Flow|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.
Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
539602|NCT00821431|P1|Participant Flow|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.
Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:
Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.
Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
539603|NCT00821431|O2|Outcome|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.
Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
539604|NCT00821431|O1|Outcome|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.
Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:
Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.
Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
539605|NCT00821431|O2|Outcome|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.
Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
539606|NCT00821431|O1|Outcome|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.
Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:
Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.
Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
539607|NCT00821431|E2|Reported Event|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.
Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
539608|NCT00821431|E1|Reported Event|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.
Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:
Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.
Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
539609|NCT00821509|B4|Baseline|Total|Total of all reporting groups
539610|NCT00821509|B3|Baseline|Control|No change in hygiene behaviour
539611|NCT00821509|B2|Baseline|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
539612|NCT00821509|B1|Baseline|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
539613|NCT00821509|P3|Participant Flow|Control|No change in hygiene behaviour
539614|NCT00821509|P2|Participant Flow|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
539615|NCT00821509|P1|Participant Flow|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
539616|NCT00821509|O3|Outcome|Control|Participants were advised not to change their hand hygiene habits
539617|NCT00821509|O2|Outcome|Disinfectant Rubbing|Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution
539618|NCT00821509|O1|Outcome|Hand Washing|Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently
539619|NCT00821509|O3|Outcome|Control|Participants were advised not to change their hand hygiene habits
539620|NCT00821509|O2|Outcome|Disinfectant Rubbing|Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution
539621|NCT00821509|O1|Outcome|Hand Washing|Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently
539622|NCT00821509|E3|Reported Event|Control|No change in hygiene behaviour
539623|NCT00821509|E2|Reported Event|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
539624|NCT00821509|E1|Reported Event|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
539625|NCT00821587|B3|Baseline|Total|Total of all reporting groups
539626|NCT00821587|B2|Baseline|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
539712|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539627|NCT00821587|B1|Baseline|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
539628|NCT00821587|P2|Participant Flow|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
539629|NCT00821587|P1|Participant Flow|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
539630|NCT00821587|O2|Outcome|Cyclosporine (CsA)|Cyclosporine 2.0–4.0 mg/kg/day orally in two divided doses
539631|NCT00821587|O1|Outcome|Tacrolimus (TAC)|Tacrolimus 0.08–0.12 mg/kg/day orally in two divided doses
539632|NCT00821587|E2|Reported Event|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
539633|NCT00821587|E1|Reported Event|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
539634|NCT00821678|B3|Baseline|Total|Total of all reporting groups
539635|NCT00821678|B2|Baseline|Arm 2 Treatment as Usual|Treatment as usual
539636|NCT00821678|B1|Baseline|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care
Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
539637|NCT00821678|P2|Participant Flow|Arm 2 Treatment as Usual|Treatment as usual
539638|NCT00821678|P1|Participant Flow|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care
Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
539639|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
539640|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care
Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
539641|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
539642|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care
Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
539643|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
539644|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care
Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
539645|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
539684|NCT00821964|P1|Participant Flow|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies"
539812|NCT00822354|O4|Outcome|Week 4 of Placebo|
539646|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care
Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
539647|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
539648|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care
Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
539649|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
539650|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care
Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
539651|NCT00821678|E2|Reported Event|Arm 2 Treatment as Usual|Treatment as usual
539652|NCT00821678|E1|Reported Event|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care
Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
539653|NCT00821821|B4|Baseline|Total|Total of all reporting groups
539654|NCT00821821|B3|Baseline|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo"
539655|NCT00821821|B2|Baseline|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
539656|NCT00821821|B1|Baseline|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
539657|NCT00821821|P3|Participant Flow|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo"
539658|NCT00821821|P2|Participant Flow|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
539659|NCT00821821|P1|Participant Flow|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
539660|NCT00821821|O2|Outcome|MCI-186 Cohort2|Edaravone:circa 2000mg / 72-hour infusion
539661|NCT00821821|O1|Outcome|MCI-186 Cohort1|Edaravone:circa 1000mg / 72-hour infusion
539662|NCT00821821|O3|Outcome|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo"
539663|NCT00821821|O2|Outcome|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
539664|NCT00821821|O1|Outcome|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
539665|NCT00821821|E3|Reported Event|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo"
539666|NCT00821821|E2|Reported Event|MCI-186 Cohort2|Edaravone: circa 2000mg / 72-hour infusion
539667|NCT00821821|E1|Reported Event|MCI-186 Cohort1|Edaravone: circa 1000mg / 72-hour infusion
539668|NCT00821873|B1|Baseline|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
539669|NCT00821873|P1|Participant Flow|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
539670|NCT00821873|O1|Outcome|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
539671|NCT00821873|E1|Reported Event|Adverse Events|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
539672|NCT00821886|B1|Baseline|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate
Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)
Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52
Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
539708|NCT00822185|P1|Participant Flow|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539673|NCT00821886|P1|Participant Flow|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate
Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)
Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52
Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
539674|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate
Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)
Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52
Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
539675|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate
Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)
Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52
Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
539676|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate
Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)
Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52
Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
539677|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate
Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)
Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52
Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
539678|NCT00821886|E1|Reported Event|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate
Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)
Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52
Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
539679|NCT00821951|B1|Baseline|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction
Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
539680|NCT00821951|P1|Participant Flow|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction
Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
539681|NCT00821951|O1|Outcome|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction
Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
539682|NCT00821951|E1|Reported Event|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction
Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
539683|NCT00821964|B1|Baseline|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies"
539709|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539685|NCT00821964|O1|Outcome|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies"
539686|NCT00821964|O1|Outcome|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies"
539687|NCT00821964|O1|Outcome|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies"
539688|NCT00821964|E1|Reported Event|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
imiquimod: Given topically
Abraxane: Given IV
laboratory biomarker analysis: Correlative studies
RNA analysis: Correlative studies
immunoenzyme technique: Correlative studies"
539689|NCT00822172|B3|Baseline|Total|Total of all reporting groups
539690|NCT00822172|B2|Baseline|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
539691|NCT00822172|B1|Baseline|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.
cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
539692|NCT00822172|P2|Participant Flow|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
539693|NCT00822172|P1|Participant Flow|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.
cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
539694|NCT00822172|O2|Outcome|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
539695|NCT00822172|O1|Outcome|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.
cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
539696|NCT00822172|E2|Reported Event|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
539697|NCT00822172|E1|Reported Event|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.
cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
539698|NCT00822185|B6|Baseline|Total|Total of all reporting groups
539699|NCT00822185|B5|Baseline|Placebo|A single dose of placebo was administered intravenously
539700|NCT00822185|B4|Baseline|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539701|NCT00822185|B3|Baseline|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539702|NCT00822185|B2|Baseline|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539703|NCT00822185|B1|Baseline|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539704|NCT00822185|P5|Participant Flow|Placebo|A single dose of placebo was administered intravenously
539705|NCT00822185|P4|Participant Flow|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539706|NCT00822185|P3|Participant Flow|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539707|NCT00822185|P2|Participant Flow|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539713|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539714|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539715|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539716|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539717|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539718|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539719|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539720|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539721|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539722|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539723|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539724|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539725|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539726|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539727|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539728|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539729|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539730|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539731|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539732|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539733|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539734|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539735|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539736|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539737|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539738|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539739|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539740|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539741|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539742|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539743|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539744|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539745|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539746|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539747|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539748|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539749|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539750|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539751|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539752|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539753|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539754|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539755|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539756|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539757|NCT00822185|O5|Outcome|Placebo|A single dose of placebo was administered intravenously
539758|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539759|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539813|NCT00822354|O3|Outcome|Pre-placebo|
539760|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539761|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539762|NCT00822185|O5|Outcome|Placebo|A single dose of placebo was administered intravenously
539763|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539764|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539765|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539766|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539767|NCT00822185|E5|Reported Event|Placebo|A single dose of placebo was administered intravenously
539768|NCT00822185|E4|Reported Event|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
539769|NCT00822185|E3|Reported Event|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
539770|NCT00822185|E2|Reported Event|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
539771|NCT00822185|E1|Reported Event|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
539772|NCT00822237|B3|Baseline|Total|Total of all reporting groups
539773|NCT00822237|B2|Baseline|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
539774|NCT00822237|B1|Baseline|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
539775|NCT00822237|P2|Participant Flow|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
539776|NCT00822237|P1|Participant Flow|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
539777|NCT00822237|O1|Outcome|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
539778|NCT00822237|E2|Reported Event|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by
injection ~6 weeks apart"
539779|NCT00822237|E1|Reported Event|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by
injection ~6 weeks apart"
539780|NCT00822328|B3|Baseline|Total|Total of all reporting groups
539781|NCT00822328|B2|Baseline|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
539782|NCT00822328|B1|Baseline|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
539783|NCT00822328|P2|Participant Flow|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
539784|NCT00822328|P1|Participant Flow|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
539785|NCT00822328|O2|Outcome|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
539786|NCT00822328|O1|Outcome|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
539787|NCT00822328|O2|Outcome|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
539788|NCT00822328|O1|Outcome|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
539789|NCT00822328|E2|Reported Event|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
539790|NCT00822328|E1|Reported Event|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
539791|NCT00822354|B3|Baseline|Total|Total of all reporting groups
539792|NCT00822354|B2|Baseline|Placebo Followed by Tadalafil|Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
539793|NCT00822354|B1|Baseline|Tadalafil Followed by Placebo|Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
539794|NCT00822354|P2|Participant Flow|Placebo Followed by Tadalafil|Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
539795|NCT00822354|P1|Participant Flow|Tadalafil Followed by Placebo|Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
539796|NCT00822354|O4|Outcome|Week 4 of Placebo|
539797|NCT00822354|O3|Outcome|Pre-placebo|
539798|NCT00822354|O2|Outcome|Week 4 of Treatment|
539799|NCT00822354|O1|Outcome|Pre-treatment|
539800|NCT00822354|O4|Outcome|Week 4 of Placebo|
539801|NCT00822354|O3|Outcome|Pre-placebo|
539802|NCT00822354|O2|Outcome|Week 4 of Treatment|
539803|NCT00822354|O1|Outcome|Pre-treatment|
539804|NCT00822354|O4|Outcome|Week 4 of Placebo|
539805|NCT00822354|O3|Outcome|Pre-placebo|
539806|NCT00822354|O2|Outcome|Week 4 of Treatment|
539807|NCT00822354|O1|Outcome|Pre-treatment|
539808|NCT00822354|O4|Outcome|Week 4 of Placebo|
539809|NCT00822354|O3|Outcome|Pre-placebo|
539810|NCT00822354|O2|Outcome|Week 4 of Treatment|
539811|NCT00822354|O1|Outcome|Pre-treatment|
539821|NCT00822354|E1|Reported Event|Tadalafil|Subjects received tadalafil 20 mg every other day for four weeks.
539822|NCT00828061|B1|Baseline|All Patients|All patients who completed at least one period are included in the analysis
539823|NCT00828061|P6|Participant Flow|Prednisone / Prednisone / Placebo|1 day 25 mg prednisone, 1 day 10 mg prednisone, 1 day placebo
539824|NCT00828061|P5|Participant Flow|Prednisone / Placebo / Prednisone|1 day 10 mg prednisone, 1 day placebo, 1 day 25 mg prednisone
539825|NCT00828061|P4|Participant Flow|Placebo / Prednisone / Prednisone|1 day placebo, 1 day 25 mg prednisone, 1 day 10 mg prednisone
539826|NCT00828061|P3|Participant Flow|Prednisone / Placebo / Prednisone|1 day 25 mg prednisone, 1 day placebo, 1 day 10 mg prednisone
539827|NCT00828061|P2|Participant Flow|Prednisone / Prednisone / Placebo|1 day 10 mg prednisone, 1 day 25 mg prednisone, 1 day placebo
539828|NCT00828061|P1|Participant Flow|Placebo / Prednisone / Prednisone|1 day placebo, 1 day 10 mg prednisone, 1 day 25 mg prednisone
539829|NCT00828061|O3|Outcome|25 mg Prednisone|
539830|NCT00828061|O2|Outcome|10 mg Prednisone|
539831|NCT00828061|O1|Outcome|Placebo|
539832|NCT00828061|O3|Outcome|25 mg Prednisone|
539833|NCT00828061|O2|Outcome|10 mg Prednisone|
539834|NCT00828061|O1|Outcome|Placebo|
539835|NCT00828061|E3|Reported Event|25 mg Prednisone|
539836|NCT00828061|E2|Reported Event|10 mg Prednisone|
539837|NCT00828061|E1|Reported Event|Placebo|
539838|NCT00828074|B3|Baseline|Total|Total of all reporting groups
539839|NCT00828074|B2|Baseline|Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
539840|NCT00828074|B1|Baseline|Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
539841|NCT00828074|P3|Participant Flow|Phase II - Vinorelbine 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
539842|NCT00828074|P2|Participant Flow|Phase I - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
539843|NCT00828074|P1|Participant Flow|Phase I - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
539844|NCT00828074|O1|Outcome|Phase I & II|"Patients receive sorafenib tosylate PO twice daily on days 1-28 and vinorelbine ditartrate IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
sorafenib tosylate: Dose level 1 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle. Dose level 2 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle.
vinorelbine ditartrate: Dose level 1 = 20 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 2 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle."
539845|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
539846|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
539847|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
539848|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine I.V. 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
539849|NCT00828074|O1|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
539850|NCT00828074|O2|Outcome|Phase I: Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
539851|NCT00828074|O1|Outcome|Phase I: Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
539852|NCT00828074|E2|Reported Event|Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
539853|NCT00828074|E1|Reported Event|Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
539854|NCT00828113|B3|Baseline|Total|Total of all reporting groups
539855|NCT00828113|B2|Baseline|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
539856|NCT00828113|B1|Baseline|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
539857|NCT00828113|P2|Participant Flow|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
539858|NCT00828113|P1|Participant Flow|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
539859|NCT00828113|O2|Outcome|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
539860|NCT00828113|O1|Outcome|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
539861|NCT00828113|E2|Reported Event|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
539862|NCT00828113|E1|Reported Event|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
539863|NCT00828139|B5|Baseline|Total|Total of all reporting groups
539864|NCT00828139|B4|Baseline|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
539865|NCT00828139|B3|Baseline|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
539866|NCT00828139|B2|Baseline|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
539941|NCT00828295|O2|Outcome|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
palonosetron: palonosetron 3mcg/kg IV"
540794|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
539867|NCT00828139|B1|Baseline|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
539868|NCT00828139|P4|Participant Flow|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
539869|NCT00828139|P3|Participant Flow|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
539870|NCT00828139|P2|Participant Flow|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
539871|NCT00828139|P1|Participant Flow|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
539872|NCT00828139|O2|Outcome|Topotecan|
539873|NCT00828139|O1|Outcome|Ziv-aflibercept + Topotecan|
539874|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
539875|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
539876|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
539877|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
539878|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
539879|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
539880|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
539881|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
539882|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
539883|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
539884|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
539885|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
539886|NCT00828139|E2|Reported Event|Topotecan|There are total 92 patients in this arm, but only 87 patients with measurable disease at baseline will be included in this analysis.
539887|NCT00828139|E1|Reported Event|Ziv-aflibercept + Topotecan|There are total 97 patients in this arm, but only 92 patients with measurable disease at baseline will be included in this analysis.
539888|NCT00828178|B3|Baseline|Total|Total of all reporting groups
539889|NCT00828178|B2|Baseline|Placebo|corn starch
539890|NCT00828178|B1|Baseline|Fish Oil|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
539891|NCT00828178|P2|Participant Flow|Placebo|Placebo (corn starch) once daily
539892|NCT00828178|P1|Participant Flow|Fish Oil|fish oil 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters) daily
539893|NCT00828178|O2|Outcome|Placebo|Corn Starch
539894|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
539895|NCT00828178|O2|Outcome|Placebo|Placebo (cornstarch)
539896|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
539897|NCT00828178|O2|Outcome|Placebo|Corn starch
539898|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
539899|NCT00828178|E2|Reported Event|Placebo|Placebo (cornstarch)
539900|NCT00828178|E1|Reported Event|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
539901|NCT00828191|B3|Baseline|Total|Total of all reporting groups
539902|NCT00828191|B2|Baseline|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
539903|NCT00828191|B1|Baseline|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
539904|NCT00828191|P2|Participant Flow|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
539905|NCT00828191|P1|Participant Flow|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
539906|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
539907|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
539908|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
539909|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
539910|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
539911|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
539912|NCT00828191|E2|Reported Event|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
539913|NCT00828191|E1|Reported Event|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
539915|NCT00828204|B2|Baseline|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
539916|NCT00828204|B1|Baseline|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
539917|NCT00828204|P2|Participant Flow|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
539918|NCT00828204|P1|Participant Flow|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
539919|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
539920|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
539921|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
539922|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
539923|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
539924|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
539942|NCT00828295|O1|Outcome|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
palonosetron: palonosetron IV 1 mcg/kg"
539943|NCT00828295|E2|Reported Event|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
palonosetron: palonosetron 3mcg/kg IV"
539944|NCT00828295|E1|Reported Event|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
palonosetron: palonosetron IV 1 mcg/kg"
539925|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
539926|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
539927|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
539928|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
539929|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
539930|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
539931|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
539932|NCT00828204|E2|Reported Event|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
539933|NCT00828204|E1|Reported Event|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
539934|NCT00828295|B3|Baseline|Total|Total of all reporting groups
539935|NCT00828295|B2|Baseline|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
palonosetron: palonosetron 3mcg/kg IV"
539936|NCT00828295|B1|Baseline|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
palonosetron: palonosetron IV 1 mcg/kg"
539937|NCT00828295|P2|Participant Flow|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
palonosetron: palonosetron 3mcg/kg IV"
539938|NCT00828295|P1|Participant Flow|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
palonosetron: palonosetron IV 1 mcg/kg"
539939|NCT00828295|O2|Outcome|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
palonosetron: palonosetron 3mcg/kg IV"
539940|NCT00828295|O1|Outcome|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
palonosetron: palonosetron IV 1 mcg/kg"
543880|NCT00832416|E1|Reported Event|1: Tramadol Once A Day 100mg|
539945|NCT00828308|B1|Baseline|Ixabepilone|Ixabepilone, 16 mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care and not a part of the study)
539946|NCT00828308|P1|Participant Flow|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy.
539947|NCT00828308|O1|Outcome|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
539948|NCT00828308|E1|Reported Event|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
539949|NCT00828321|B3|Baseline|Total|Total of all reporting groups
539950|NCT00828321|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
539951|NCT00828321|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
539952|NCT00828321|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
539953|NCT00828321|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
539954|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
539955|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
539956|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
539957|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
539958|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
539959|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
539960|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
539961|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
539962|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
539963|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
539964|NCT00828347|B3|Baseline|Total|Total of all reporting groups
539965|NCT00828347|B2|Baseline|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
539966|NCT00828347|B1|Baseline|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
539967|NCT00828347|P2|Participant Flow|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
539968|NCT00828347|P1|Participant Flow|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
539969|NCT00828347|O2|Outcome|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
539970|NCT00828347|O1|Outcome|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
539971|NCT00828347|E2|Reported Event|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
539972|NCT00828347|E1|Reported Event|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
539973|NCT00829166|B3|Baseline|Total|Total of all reporting groups
539974|NCT00829166|B2|Baseline|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
539975|NCT00829166|B1|Baseline|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
539976|NCT00829166|P2|Participant Flow|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
539977|NCT00829166|P1|Participant Flow|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
539978|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
540064|NCT00829296|B2|Baseline|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Metoprolol"
546462|NCT00847886|B3|Baseline|Total|Total of all reporting groups
539979|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
539980|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
539981|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
539982|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
539983|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
539984|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
539985|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
539986|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
539987|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
539988|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
539989|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
539990|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
539991|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
539992|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
539993|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
539994|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
539995|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
539996|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
540065|NCT00829296|B1|Baseline|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
nebivolol"
539997|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
539998|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
539999|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
540000|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
540001|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
540002|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
540003|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
540004|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
540005|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
540006|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
540007|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
540008|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
540009|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
540010|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
540011|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
540012|NCT00829166|E3|Reported Event|Lapatinib + Capecitabine/ Trastuzumab Emtansine|"Participants of Lapatinib + Capecitabine arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis."
540013|NCT00829166|E2|Reported Event|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
540014|NCT00829166|E1|Reported Event|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
540015|NCT00829179|B1|Baseline|RhuMab-E25|
540038|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540016|NCT00829179|P1|Participant Flow|RhuMab-E25|"Subjects with mild asthma received three doses of study drug subcutaneous injections at one month intervals. Dosing range was 150mg-375mg which was based on baseline IGE and subject body weight.
Subjects with a baseline Ige above 30 and up to 100 with a body weight between 30 and 150kg would receive a study drug dose of 150 mg. Subjects with an IGE 100-200 and body weight 30 - 150 kg would receive a dose of 225 mg. And up to subjects with an IGE of 600-700 only body weight of 30 - 60 would be included with a dose of 375 mg."
540017|NCT00829179|O1|Outcome|RhuMab-E25|
540018|NCT00829179|E1|Reported Event|RhuMab-E25|
540019|NCT00829244|B3|Baseline|Total|Total of all reporting groups
540020|NCT00829244|B2|Baseline|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
540021|NCT00829244|B1|Baseline|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540022|NCT00829244|P2|Participant Flow|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
540023|NCT00829244|P1|Participant Flow|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540024|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540025|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540026|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540027|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540028|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540029|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540030|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540031|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540032|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540033|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540034|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540035|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540036|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540037|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540126|NCT00829452|B3|Baseline|Total|Total of all reporting groups
540039|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540040|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540041|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540042|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540043|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540044|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540045|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540046|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540047|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540048|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
540049|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540050|NCT00829244|E2|Reported Event|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
540051|NCT00829244|E1|Reported Event|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
540052|NCT00829283|B3|Baseline|Total|Total of all reporting groups
540053|NCT00829283|B2|Baseline|Stepped-care|"Stepped-care
Behavioral Weight Loss: weekly individual sessions for 6 months
Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
Placebo: One pill daily
Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
540054|NCT00829283|B1|Baseline|Standard Care|"Standard Care
Behavioral Weight Loss: weekly individual sessions for 6 months"
540055|NCT00829283|P2|Participant Flow|Stepped-care|"Stepped-care
Behavioral Weight Loss: weekly individual sessions for 6 months
Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
Placebo: One pill daily
Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
540056|NCT00829283|P1|Participant Flow|Standard Care|"Standard Care
Behavioral Weight Loss: weekly individual sessions for 6 months"
540057|NCT00829283|O2|Outcome|Stepped-care|"Stepped-care
Behavioral Weight Loss: weekly individual sessions for 6 months
Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
Placebo: One pill daily
Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
540058|NCT00829283|O1|Outcome|Standard Care|"Standard Care
Behavioral Weight Loss: weekly individual sessions for 6 months"
540059|NCT00829283|O2|Outcome|Stepped-care|"Stepped-care
Behavioral Weight Loss: weekly individual sessions for 6 months
Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
Placebo: One pill daily
Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
540060|NCT00829283|O1|Outcome|Standard Care|"Standard Care
Behavioral Weight Loss: weekly individual sessions for 6 months"
540061|NCT00829283|E2|Reported Event|Stepped-care|"Stepped-care
Behavioral Weight Loss: weekly individual sessions for 6 months
Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
Placebo: One pill daily
Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
540062|NCT00829283|E1|Reported Event|Standard Care|"Standard Care
Behavioral Weight Loss: weekly individual sessions for 6 months"
540063|NCT00829296|B3|Baseline|Total|Total of all reporting groups
540066|NCT00829296|P2|Participant Flow|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Metoprolol"
540067|NCT00829296|P1|Participant Flow|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
nebivolol"
540068|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Metoprolol"
540069|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
nebivolol"
540070|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Metoprolol"
540071|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
nebivolol"
540072|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Metoprolol"
540073|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
nebivolol"
540074|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Metoprolol"
540075|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
nebivolol"
540076|NCT00829296|E2|Reported Event|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Metoprolol"
540077|NCT00829296|E1|Reported Event|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
nebivolol"
540078|NCT00829309|B3|Baseline|Total|Total of all reporting groups
540079|NCT00829309|B2|Baseline|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
540080|NCT00829309|B1|Baseline|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
540081|NCT00829309|P2|Participant Flow|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
540082|NCT00829309|P1|Participant Flow|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
540083|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
540084|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
540085|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
540086|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
540087|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
540088|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
540089|NCT00829387|B3|Baseline|Total|Total of all reporting groups
540090|NCT00829387|B2|Baseline|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
540091|NCT00829387|B1|Baseline|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
540092|NCT00829387|P2|Participant Flow|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
540093|NCT00829387|P1|Participant Flow|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
540094|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
540095|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
540096|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
540097|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
540098|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
540099|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
540127|NCT00829452|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
540358|NCT00830076|E2|Reported Event|Metformin + Placebo Sitagliptin|Participants received metformin + placebo sitagliptin for 2 days.
540100|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
540101|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
540102|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
540103|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
540104|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
540105|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
540106|NCT00829387|E2|Reported Event|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
540107|NCT00829387|E1|Reported Event|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
540108|NCT00829426|B3|Baseline|Total|Total of all reporting groups
540109|NCT00829426|B2|Baseline|Xanax® (Reference) First|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
540110|NCT00829426|B1|Baseline|Alprazolam (Test) First|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
540111|NCT00829426|P2|Participant Flow|Xanax® (Reference) First|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
540112|NCT00829426|P1|Participant Flow|Alprazolam (Test) First|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
540113|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
540114|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
540115|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
540116|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
540117|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
540118|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
540119|NCT00829439|B1|Baseline|Levodopa/Carbidopa|"Other Names:
Sinemet L-dopa
Dosages are based on levodopa.
Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.
Levodopa/Carbidopa (4:1): Dosages are based on levodopa.
Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
540120|NCT00829439|P4|Participant Flow|Levodopa / Carbidopa 15 mg/kg/Day|Levodopa / Carbidopa 15 mg/kg/day in 3 divided doses
540121|NCT00829439|P3|Participant Flow|Levodopa / Carbidopa 10 mg/kg/Day|Levodopa 10 mg/kg/day in 3 divided doses
540122|NCT00829439|P2|Participant Flow|Levodopa / Carbidopa 5 mg/kg/Day|Levodopa 5 mg/kg/day in 3 divided doses
540123|NCT00829439|P1|Participant Flow|Levodopa/Carbidopa 2 mg/kg/Day|Levodopa at 2 mg/kg/day in 3 divided doses
540124|NCT00829439|O1|Outcome|Levodopa/Carbidopa|"Other Names:
Sinemet L-dopa
Dosages are based on levodopa.
Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.
Levodopa/Carbidopa (4:1): Dosages are based on levodopa.
Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
540125|NCT00829439|E1|Reported Event|Levodopa/Carbidopa|"Other Names:
Sinemet L-dopa
Dosages are based on levodopa.
Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.
Levodopa/Carbidopa (4:1): Dosages are based on levodopa.
Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
540128|NCT00829452|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
540129|NCT00829452|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
540130|NCT00829452|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
540131|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
540132|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
540133|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
540134|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
540135|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
540136|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
540137|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
540138|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
540139|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
540140|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
540141|NCT00829504|B3|Baseline|Total|Total of all reporting groups
540142|NCT00829504|B2|Baseline|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
540143|NCT00829504|B1|Baseline|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
540144|NCT00829504|P2|Participant Flow|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
540145|NCT00829504|P1|Participant Flow|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
540146|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
540147|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
540148|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
540149|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
540150|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
540151|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
540152|NCT00829530|B3|Baseline|Total|Total of all reporting groups
540153|NCT00829530|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
540154|NCT00829530|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
540155|NCT00829530|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
540156|NCT00829530|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
540157|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
540158|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
540159|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
540160|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
540161|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
540162|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
540163|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
540164|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
540165|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
540166|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
540167|NCT00829621|B3|Baseline|Total|Total of all reporting groups
540168|NCT00829621|B2|Baseline|125 mmHg|"IVAC suction 125 mmHg
125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
540169|NCT00829621|B1|Baseline|75 mmHg|"IVAC suction 75 mmHg
75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
540170|NCT00829621|P2|Participant Flow|125 mmHg|"IVAC suction 125 mmHg
125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
540171|NCT00829621|P1|Participant Flow|75 mmHg|"IVAC suction 75 mmHg
75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
540172|NCT00829621|O2|Outcome|125 mmHg|"IVAC suction 125 mmHg
125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
540173|NCT00829621|O1|Outcome|75 mmHg|"IVAC suction 75 mmHg
75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
540174|NCT00829621|E2|Reported Event|125 mmHg|"IVAC suction 125 mmHg
125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
540175|NCT00829621|E1|Reported Event|75 mmHg|"IVAC suction 75 mmHg
75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
540176|NCT00829673|B3|Baseline|Total|Total of all reporting groups
540177|NCT00829673|B2|Baseline|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
540178|NCT00829673|B1|Baseline|Dexmethylphenidate HCl First|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
540179|NCT00829673|P2|Participant Flow|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
540180|NCT00829673|P1|Participant Flow|Dexmethylphenidate HCl First|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
540181|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
540182|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
540183|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
540184|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
540185|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
540186|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
540187|NCT00829686|B3|Baseline|Total|Total of all reporting groups
540188|NCT00829686|B2|Baseline|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
540189|NCT00829686|B1|Baseline|No Intervention|No antibiotic
540190|NCT00829686|P2|Participant Flow|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
540191|NCT00829686|P1|Participant Flow|No Intervention|No antibiotic
540192|NCT00829686|O2|Outcome|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
540193|NCT00829686|O1|Outcome|No Intervention|No antibiotic
540194|NCT00829686|O2|Outcome|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
540195|NCT00829686|O1|Outcome|No Intervention|No antibiotic
540196|NCT00829712|B3|Baseline|Total|Total of all reporting groups
540197|NCT00829712|B2|Baseline|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the second period.
540198|NCT00829712|B1|Baseline|Dexmethylphenidate HCl First|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
540199|NCT00829712|P2|Participant Flow|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the second period.
540200|NCT00829712|P1|Participant Flow|Dexmethylphenidate HCl First|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
540201|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
540202|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
540203|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
540204|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
540205|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
540206|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
540207|NCT00829738|B1|Baseline|Pantoprazole|All patients enrolled
540208|NCT00829738|P1|Participant Flow|Pantoprazole|All patients enrolled
540209|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
540210|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
540211|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540212|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540213|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540214|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
540215|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540216|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540217|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540218|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
540219|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540220|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540221|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540222|NCT00829738|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
540223|NCT00829764|B3|Baseline|Total|Total of all reporting groups
540224|NCT00829764|B2|Baseline|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
540225|NCT00829764|B1|Baseline|Doxycycline Monohydrate First|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
540262|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
540226|NCT00829764|P2|Participant Flow|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
540227|NCT00829764|P1|Participant Flow|Doxycycline Monohydrate First|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
540228|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
540229|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
540230|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
540231|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
540232|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
540233|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
540234|NCT00829790|B3|Baseline|Total|Total of all reporting groups
540235|NCT00829790|B2|Baseline|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
540236|NCT00829790|B1|Baseline|Doxycycline Monohydrate First|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
540237|NCT00829790|P2|Participant Flow|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
540238|NCT00829790|P1|Participant Flow|Doxycycline Monohydrate First|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
540239|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
540240|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
540241|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
540242|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
540243|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
540244|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
540245|NCT00829829|B4|Baseline|Total|Total of all reporting groups
540246|NCT00829829|B3|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
540247|NCT00829829|B2|Baseline|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
540248|NCT00829829|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
540249|NCT00829829|P3|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
540250|NCT00829829|P2|Participant Flow|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
540251|NCT00829829|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
540252|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
540253|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
540254|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
540255|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
540256|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
540257|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
540258|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
540259|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
540260|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
540261|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
540445|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540263|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
540264|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
540265|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
540266|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
540267|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
540268|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
540269|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
540270|NCT00829829|E3|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
540271|NCT00829829|E2|Reported Event|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
540272|NCT00829829|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
540273|NCT00829868|B3|Baseline|Total|Total of all reporting groups
540274|NCT00829868|B2|Baseline|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
540275|NCT00829868|B1|Baseline|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
540276|NCT00829868|P2|Participant Flow|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
540277|NCT00829868|P1|Participant Flow|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
540278|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
540279|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
540280|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
540281|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
540282|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
540283|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
540284|NCT00829933|B5|Baseline|Total|Total of all reporting groups
540285|NCT00829933|B4|Baseline|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
540286|NCT00829933|B3|Baseline|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
540287|NCT00829933|B2|Baseline|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
540288|NCT00829933|B1|Baseline|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
540289|NCT00829933|P4|Participant Flow|Warfarin|"Warfarin potassium tablets:
Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose"
540290|NCT00829933|P3|Participant Flow|DU-176b High Dose 60mg|"DU-176b tablets:
DU-176b tablets taken once daily for 12 weeks"
540291|NCT00829933|P2|Participant Flow|DU-176b Intermediate Dose 45mg|"DU-176b tablets:
DU-176b tablets taken once daily for 12 weeks"
540292|NCT00829933|P1|Participant Flow|DU-176b Low Dose 30mg|"DU-176b tablets:
DU-176b tablets taken once daily for 12 weeks"
540293|NCT00829933|O4|Outcome|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
540294|NCT00829933|O3|Outcome|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
540295|NCT00829933|O2|Outcome|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
540296|NCT00829933|O1|Outcome|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
540297|NCT00829933|E4|Reported Event|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
540298|NCT00829933|E3|Reported Event|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
540299|NCT00829933|E2|Reported Event|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
540300|NCT00829933|E1|Reported Event|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
540301|NCT00829985|B3|Baseline|Total|Total of all reporting groups
540302|NCT00829985|B2|Baseline|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
540303|NCT00829985|B1|Baseline|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
540319|NCT00829998|B2|Baseline|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
540320|NCT00829998|B1|Baseline|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
540304|NCT00829985|P2|Participant Flow|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
540305|NCT00829985|P1|Participant Flow|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
540306|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
540307|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
540308|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
540309|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
540310|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
540311|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
540312|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
540313|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
540314|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
540315|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
540316|NCT00829985|E2|Reported Event|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
540317|NCT00829985|E1|Reported Event|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
540318|NCT00829998|B3|Baseline|Total|Total of all reporting groups
540321|NCT00829998|P2|Participant Flow|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
540322|NCT00829998|P1|Participant Flow|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
540323|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
540324|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
540325|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
540326|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
540327|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
540328|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
540329|NCT00830024|B3|Baseline|Total|Total of all reporting groups
540330|NCT00830024|B2|Baseline|Reference First|Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
540331|NCT00830024|B1|Baseline|Test First|Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period
540332|NCT00830024|P2|Participant Flow|Reference First|Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
540333|NCT00830024|P1|Participant Flow|Test First|Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period
540334|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
540335|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
540336|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
540337|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
540338|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
540339|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
540340|NCT00830037|B3|Baseline|Total|Total of all reporting groups
540341|NCT00830037|B2|Baseline|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
540342|NCT00830037|B1|Baseline|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
540343|NCT00830037|P2|Participant Flow|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
540344|NCT00830037|P1|Participant Flow|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
540345|NCT00830037|O2|Outcome|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
540346|NCT00830037|O1|Outcome|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
540347|NCT00830037|O2|Outcome|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
540348|NCT00830037|O1|Outcome|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
540349|NCT00830037|E2|Reported Event|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
540350|NCT00830037|E1|Reported Event|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
540351|NCT00830076|B1|Baseline|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
540352|NCT00830076|P1|Participant Flow|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
540353|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
540354|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
540355|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
540356|NCT00830076|E4|Reported Event|Placebo Sitagliptin + Placebo Metformin|Participants received placebo sitagliptin + placebo metformin for 2 days.
540357|NCT00830076|E3|Reported Event|Sitagliptin + Metformin|Participants received co-administration of sitagliptin + metformin for 2 days.
547423|NCT00842829|B3|Baseline|Total|Total of all reporting groups
540359|NCT00830076|E1|Reported Event|Sitagliptin + Placebo Metformin|Participants received sitagliptin + placebo metformin for 2 days.
540360|NCT00830115|B1|Baseline|Pantoprazole|All patients enrolled
540361|NCT00830115|P1|Participant Flow|Pantoprazole|All patients enrolled
540362|NCT00830115|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
540363|NCT00830115|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
540364|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540365|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540366|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540367|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
540368|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
540369|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
540370|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
540371|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
540372|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
540373|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
540374|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
540375|NCT00830115|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
540376|NCT00830128|B1|Baseline|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540377|NCT00830128|P1|Participant Flow|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540378|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540379|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540380|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540381|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540382|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540383|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540384|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540385|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540386|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540387|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540388|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540389|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540390|NCT00830128|E1|Reported Event|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
540391|NCT00830167|B3|Baseline|Total|Total of all reporting groups
540392|NCT00830167|B2|Baseline|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540393|NCT00830167|B1|Baseline|Placebo|Placebo was administered twice a day for 15 weeks.
540394|NCT00830167|P2|Participant Flow|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540395|NCT00830167|P1|Participant Flow|Placebo|Placebo was administered twice a day for 15 weeks.
540396|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540397|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540398|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540399|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540400|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540401|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540402|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540403|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540404|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540405|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540406|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540407|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540408|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540409|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540410|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540411|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540412|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540413|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540414|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540415|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540416|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540417|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540418|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540419|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540420|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540421|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540422|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540423|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540424|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540425|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540426|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540427|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540428|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540429|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540430|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540431|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540432|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540433|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540434|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540435|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540436|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540437|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540438|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540439|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540440|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540441|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540442|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540443|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540444|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
551708|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
540446|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540447|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540448|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540449|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540450|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540451|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540452|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540453|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540454|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540455|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540456|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540457|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540458|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540459|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540460|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540461|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
540462|NCT00830167|E2|Reported Event|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
540463|NCT00830167|E1|Reported Event|Placebo|Placebo was administered twice a day for 15 weeks.
540464|NCT00830206|B3|Baseline|Total|Total of all reporting groups
540465|NCT00830206|B2|Baseline|Zithromax® (Reference) First|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
540466|NCT00830206|B1|Baseline|Azithromycin (Test) First|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
540467|NCT00830206|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
540468|NCT00830206|P1|Participant Flow|Azithromycin (Test) First|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
540469|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
540470|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
540471|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
540472|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
540473|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
540474|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
540475|NCT00830219|B3|Baseline|Total|Total of all reporting groups
540476|NCT00830219|B2|Baseline|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
540477|NCT00830219|B1|Baseline|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
540478|NCT00830219|P2|Participant Flow|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
552227|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
540479|NCT00830219|P1|Participant Flow|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
540480|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
540481|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
540482|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
540483|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
540484|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
540485|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
540486|NCT00830232|B3|Baseline|Total|Total of all reporting groups
540487|NCT00830232|B2|Baseline|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
540488|NCT00830232|B1|Baseline|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
540489|NCT00830232|P2|Participant Flow|Open-cell Stent|"Patients enrolled in this study arm underwent for carotid stenting using open stent cell stents. This type of stent is a tube shaped graft composed of flexible nitinol rings. The device used in this group was the Acculinx open-cell stent.
Stenting procedure eas performed on standard fashion.Filters were used as embolic protection device."
540490|NCT00830232|P1|Participant Flow|Closed-cell Stent|"Patients enrolled in this study arm underwent for carotid stenting using closed stent cell. The graft used in this group was the Xact closed-cell stent. This type of device is a rigid device with a dense composition between the nitinol rings.
Carotid stenting was used on standard fashion using filters as embolic protection device."
540491|NCT00830232|O2|Outcome|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
540492|NCT00830232|O1|Outcome|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
540493|NCT00830232|E2|Reported Event|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
540494|NCT00830232|E1|Reported Event|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
540495|NCT00830258|B3|Baseline|Total|Total of all reporting groups
540496|NCT00830258|B2|Baseline|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
540497|NCT00830258|B1|Baseline|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
540498|NCT00830258|P2|Participant Flow|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
540499|NCT00830258|P1|Participant Flow|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
540500|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
540501|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
540502|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
540503|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
540504|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
540505|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
540506|NCT00830284|B1|Baseline|Recruitment|"Patients with hypoxic respiratory failure
Recruitment maneuver: Three types of maneuvers will be performed.
6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.
6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.
PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
540507|NCT00830284|P1|Participant Flow|Recruitment|"Patients with hypoxic respiratory failure
Recruitment maneuver: Three types of maneuvers will be performed.
6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.
6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.
PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
540508|NCT00830284|O1|Outcome|Recruitment|"Patients with hypoxic respiratory failure
Recruitment maneuver: Three types of maneuvers will be performed.
6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.
6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.
PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
540509|NCT00830284|O1|Outcome|Recruitment|"Patients with hypoxic respiratory failure
Recruitment maneuver: Three types of maneuvers will be performed.
6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.
6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.
PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
540510|NCT00830284|E1|Reported Event|Recruitment|"Patients with hypoxic respiratory failure
Recruitment maneuver: Three types of maneuvers will be performed.
6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.
6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.
PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
540548|NCT00830388|P1|Participant Flow|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
540549|NCT00830388|O1|Outcome|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
540511|NCT00830310|B1|Baseline|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540512|NCT00830310|P1|Participant Flow|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540513|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540514|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540515|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540516|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540517|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540518|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540519|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540789|NCT00831129|P2|Participant Flow|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540520|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540521|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540522|NCT00830310|E1|Reported Event|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.
Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.
An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
540523|NCT00830336|B3|Baseline|Total|Total of all reporting groups
540524|NCT00830336|B2|Baseline|Zithromax® (Reference) First|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
540525|NCT00830336|B1|Baseline|Azithromycin (Test) First|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
540526|NCT00830336|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
540527|NCT00830336|P1|Participant Flow|Azithromycin (Test) First|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
540528|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
540529|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
540530|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
540531|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
540532|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
540533|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
540534|NCT00830362|B3|Baseline|Total|Total of all reporting groups
540535|NCT00830362|B2|Baseline|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
540536|NCT00830362|B1|Baseline|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
540537|NCT00830362|P2|Participant Flow|Placebo|Placebo : administered once. The subjects whose data we analyzed upon study completion who received placebo were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
540538|NCT00830362|P1|Participant Flow|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects whose data we analyzed upon study completion who received propranolol were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
540539|NCT00830362|O2|Outcome|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
540540|NCT00830362|O1|Outcome|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
540541|NCT00830362|E2|Reported Event|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
540542|NCT00830362|E1|Reported Event|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
540543|NCT00830375|B1|Baseline|Memantine|10-30mg tablets of memantine taken once daily by mouth
540544|NCT00830375|P1|Participant Flow|Memantine|10-30mg tablets of memantine taken once daily by mouth
540545|NCT00830375|O1|Outcome|Memantine|10-30mg tablets of memantine taken once daily by mouth
540546|NCT00830375|E1|Reported Event|Memantine|10-30mg tablets of memantine taken once daily by mouth
540547|NCT00830388|B1|Baseline|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
540790|NCT00831129|P1|Participant Flow|Placebo|simvastatin 40 mg/day plus placebo
540550|NCT00830388|O1|Outcome|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
540551|NCT00830388|E1|Reported Event|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
540552|NCT00830440|B3|Baseline|Total|Total of all reporting groups
540553|NCT00830440|B2|Baseline|Control: (Diet and Lifestyle Counseling)|"Diet + Lifestyle counseling
Diet + Lifestyle Counseling: Monthly Visits"
540554|NCT00830440|B1|Baseline|EndoBarrier and Diet/Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling
EndoBarrier: Monthly visits"
540555|NCT00830440|P2|Participant Flow|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling
Diet + Lifestyle Counseling: Monthly Visits"
540556|NCT00830440|P1|Participant Flow|EndoBarrier Device|"EndoBarrier + Diet + Lifestyle counseling 12 Week implant duration
EndoBarrier: Monthly visits"
540557|NCT00830440|O2|Outcome|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling
Diet + Lifestyle Counseling: Monthly Visits"
540558|NCT00830440|O1|Outcome|EndoBarrier/Diet and Lifestyle Counseling/12 Weeks|12 week implantation period
540559|NCT00830440|O2|Outcome|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling
Diet + Lifestyle Counseling: Monthly Visits"
540560|NCT00830440|O1|Outcome|EndoBarrier and Diet and Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling
EndoBarrier: Monthly visits"
540561|NCT00830440|O2|Outcome|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling
Diet + Lifestyle Counseling: Monthly Visits"
540562|NCT00830440|O1|Outcome|EndoBarrier/Diet and Lifestyle Counseling/12 Weeks|12 week implantation period
540563|NCT00830440|E2|Reported Event|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling
Diet + Lifestyle Counseling: Monthly Visits"
540564|NCT00830440|E1|Reported Event|EndoBarrier and Diet and Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling
EndoBarrier: Monthly visits"
540565|NCT00830765|B3|Baseline|Total|Total of all reporting groups
540566|NCT00830765|B2|Baseline|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
540567|NCT00830765|B1|Baseline|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
540568|NCT00830765|P2|Participant Flow|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
540569|NCT00830765|P1|Participant Flow|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
540570|NCT00830765|O2|Outcome|Placebo Group|Progesterone injection was compared to placebo injection on a weekly basis.
540571|NCT00830765|O1|Outcome|Progesterone Group|Progesterone injection was compared to placebo injection on a weekly basis.
540572|NCT00830765|E2|Reported Event|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
540573|NCT00830765|E1|Reported Event|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
540574|NCT00830791|B7|Baseline|Total|Total of all reporting groups
540575|NCT00830791|B6|Baseline|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
540576|NCT00830791|B5|Baseline|MK-0941 5 mg Severe Renal Insufficiency|MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
540577|NCT00830791|B4|Baseline|Control + 20 mg MK-0941|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540578|NCT00830791|B3|Baseline|MK-0941 20 mg Moderate Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
540579|NCT00830791|B2|Baseline|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540580|NCT00830791|B1|Baseline|MK-0941 20 mg Mild Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
540581|NCT00830791|P6|Participant Flow|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
540582|NCT00830791|P5|Participant Flow|MK-0941 5 mg Severe Renal Insufficiency|MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
540583|NCT00830791|P4|Participant Flow|Control + 20 mg MK-0941|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540584|NCT00830791|P3|Participant Flow|MK-0941 20 mg Moderate Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
540585|NCT00830791|P2|Participant Flow|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540586|NCT00830791|P1|Participant Flow|MK-0941 20 mg Mild Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
540587|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg.
540588|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
552228|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
540589|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg (10 mg x 2).
540590|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540591|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg (10 mg x 2).
540592|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540593|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
540594|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
540595|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose (10 mg x 2).
540596|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540597|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose (10 mg x 2).
540598|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540599|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose of 10 mg x 2.
540600|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
540601|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540602|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540603|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540604|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540605|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
540606|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
540607|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540608|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540609|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540610|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540611|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
540612|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
540613|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540614|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540615|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540616|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540617|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
540618|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
540619|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540620|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540621|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
540622|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
540623|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540624|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540625|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540626|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540627|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540628|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
540629|NCT00830791|E3|Reported Event|MK-0941 20 mg and Moderate Renal Insufficiency|MK-0941 was administered as a single oral dose of 20 mg to participants with moderate renal insufficiency.
540630|NCT00830791|E2|Reported Event|MK-0941 20 mg and Mild Renal Insufficiency|MK-0941 was administered as a single oral dose to participants with mild renal insufficiency.
540631|NCT00830791|E1|Reported Event|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
540632|NCT00830804|B1|Baseline|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540633|NCT00830804|P1|Participant Flow|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540634|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540635|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540636|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540637|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540638|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540639|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540640|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540641|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540642|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540643|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540644|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540645|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540646|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540647|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540648|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540649|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540650|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540651|NCT00830804|E1|Reported Event|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
540652|NCT00830947|B3|Baseline|Total|Total of all reporting groups
540653|NCT00830947|B2|Baseline|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
540654|NCT00830947|B1|Baseline|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
540655|NCT00830947|P2|Participant Flow|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
540656|NCT00830947|P1|Participant Flow|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
540657|NCT00830947|O2|Outcome|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
540658|NCT00830947|O1|Outcome|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
540659|NCT00830947|E2|Reported Event|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
540660|NCT00830947|E1|Reported Event|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
540661|NCT00830960|B7|Baseline|Total|Total of all reporting groups
540662|NCT00830960|B6|Baseline|Clopidogrel 300/75 Low Weight/Elderly|Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
540663|NCT00830960|B5|Baseline|Prasugrel 30/5 Low Weight/Elderly|Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
540664|NCT00830960|B4|Baseline|Clopidogrel 300/75 Primary|Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540665|NCT00830960|B3|Baseline|Prasugrel 30/5 Primary|Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540666|NCT00830960|B2|Baseline|Prasugrel 30/7.5 Primary|Study treatment of prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540667|NCT00830960|B1|Baseline|Prasugrel 60/10 Primary|"Study treatment of prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
Reporting groups for Baseline Characteristics do not include all randomized participants (n=720), but includes all randomized participants who received at least 1 dose of study drug."
540668|NCT00830960|P6|Participant Flow|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
540669|NCT00830960|P5|Participant Flow|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
540670|NCT00830960|P4|Participant Flow|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540671|NCT00830960|P3|Participant Flow|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540672|NCT00830960|P2|Participant Flow|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540673|NCT00830960|P1|Participant Flow|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540674|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540675|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540676|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540677|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540678|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540679|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540680|NCT00830960|O4|Outcome|Clopidogrel 300/75 PD|Population includes participants in genetics substudy who were randomly assigned to receive a clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
540681|NCT00830960|O3|Outcome|Prasugrel 30/5 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
540682|NCT00830960|O2|Outcome|Prasugrel 30/7.5 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
540683|NCT00830960|O1|Outcome|Prasugrel 60/10 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary Cohort.
540684|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540685|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540686|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540687|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540688|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540689|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540690|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540691|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540692|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540693|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540694|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540695|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540696|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540697|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
552229|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
540698|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540699|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540700|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540701|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540702|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540703|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540704|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540705|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540706|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540707|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540708|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540709|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540710|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540711|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540712|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540713|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540714|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540715|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540716|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540717|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540718|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540719|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540720|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540721|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540722|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540723|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540724|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540725|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540791|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540726|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540727|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540728|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540729|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540730|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540731|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540732|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540733|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540734|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540735|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540736|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540737|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540738|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
540739|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
540740|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540741|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540742|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540743|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540744|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants in primary cohort randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort participant weight ≥60 kg and age <75 years)
540745|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540746|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540747|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540748|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
540749|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
540750|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540751|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540752|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540753|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540754|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540755|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
540756|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540757|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540758|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540759|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540760|NCT00830960|O5|Outcome|Clopidogrel 300-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were treated with a clopidogrel 300-mg LD.
540761|NCT00830960|O4|Outcome|Prasugrel 30-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were treated with a prasugrel 30-mg LD.
540762|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were treated with a clopidogrel 300-mg LD.
540763|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were treated with a prasugrel 30-mg LD(including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
540764|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort who were treated with a prasugrel 60-mg LD.
540765|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
540766|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
540767|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540768|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540769|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540770|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
540771|NCT00830960|O5|Outcome|Clopidogrel 300-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
540772|NCT00830960|O4|Outcome|Prasugrel 30-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
540773|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
540774|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
540775|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
540776|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
540777|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
540778|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
540779|NCT00830960|E7|Reported Event|Clopidogrel 300/75 No Weight|Participant didn't have weight recorded. Loading dose 300 mg followed by maintenance dose 75 mg/day
540780|NCT00830960|E6|Reported Event|Clopidogrel 300/75 Low Weight/Elderly|Low Weight/Elderly = participant weight <60 kg or age ≥75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
540781|NCT00830960|E5|Reported Event|Prasugrel 30/5 Low Weight/Elderly|Low Weight/Elderly = participant weight <60 kg or age ≥75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
540782|NCT00830960|E4|Reported Event|Clopidogrel 300/75 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
540783|NCT00830960|E3|Reported Event|Prasugrel 30/5 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
540784|NCT00830960|E2|Reported Event|Prasugrel 30/7.5 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 30mg followed by maintenance dose 7.5 mg/day
540785|NCT00830960|E1|Reported Event|Prasugrel 60/10 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 60 mg followed by maintenance dose 10 mg/day.
540786|NCT00831129|B3|Baseline|Total|Total of all reporting groups
540787|NCT00831129|B2|Baseline|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540788|NCT00831129|B1|Baseline|Placebo|simvastatin 40 mg/day plus placebo
540795|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540796|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540797|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540798|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540799|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540800|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540801|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540802|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540803|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540804|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540805|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540806|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540807|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540808|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540809|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540810|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540811|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540812|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540813|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540814|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540815|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540816|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540817|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540818|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540819|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540820|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540821|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540822|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
540823|NCT00831129|E2|Reported Event|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
540824|NCT00831129|E1|Reported Event|Placebo|simvastatin 40 mg/day plus placebo
540825|NCT00831233|B3|Baseline|Total|Total of all reporting groups
540826|NCT00831233|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540827|NCT00831233|B1|Baseline|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540828|NCT00831233|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540829|NCT00831233|P1|Participant Flow|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540830|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540831|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540832|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540833|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540834|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540835|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540836|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540837|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540838|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540839|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540840|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540841|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540842|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540843|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540844|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540845|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540846|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540847|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540848|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540849|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540850|NCT00831233|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
540851|NCT00831233|E1|Reported Event|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
540852|NCT00831272|B5|Baseline|Total|Total of all reporting groups
540853|NCT00831272|B4|Baseline|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
540854|NCT00831272|B3|Baseline|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
540855|NCT00831272|B2|Baseline|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
540856|NCT00831272|B1|Baseline|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
540857|NCT00831272|P4|Participant Flow|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
540858|NCT00831272|P3|Participant Flow|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
540859|NCT00831272|P2|Participant Flow|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
540860|NCT00831272|P1|Participant Flow|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
540861|NCT00831272|O4|Outcome|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
540862|NCT00831272|O3|Outcome|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
540863|NCT00831272|O2|Outcome|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
540864|NCT00831272|O1|Outcome|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
540865|NCT00831272|E4|Reported Event|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
540866|NCT00831272|E3|Reported Event|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
540867|NCT00831272|E2|Reported Event|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
540868|NCT00831272|E1|Reported Event|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
540869|NCT00831311|B3|Baseline|Total|Total of all reporting groups
540870|NCT00831311|B2|Baseline|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
540871|NCT00831311|B1|Baseline|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
540872|NCT00831311|P2|Participant Flow|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
540873|NCT00831311|P1|Participant Flow|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
540874|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
540875|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
540876|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
540877|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
540878|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
540879|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
540880|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
540881|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
540882|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
540883|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
540884|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
540885|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
540886|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
540887|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
540888|NCT00831311|E2|Reported Event|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
540889|NCT00831311|E1|Reported Event|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
540890|NCT00831389|B1|Baseline|All Study Participants|Four day inpatient study with exercise (on second or third day based on randomization) with closed loop insulin delivery system for glycemic control.
540891|NCT00831389|P1|Participant Flow|All Participants|All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540892|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540893|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540894|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
541498|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
540895|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540896|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540897|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540898|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540899|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540900|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540901|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540902|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540903|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540904|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540905|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540906|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540907|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540908|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540909|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540910|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540911|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540912|NCT00831389|E2|Reported Event|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540913|NCT00831389|E1|Reported Event|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
540914|NCT00831415|B1|Baseline|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
540915|NCT00831415|P1|Participant Flow|DVS SR|Desvenlafaxine succinate sustained release formulation (DVS SR) flexible dose 25 milligrams per day (mg/day) up to 100 mg/day.
540916|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
540917|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
540918|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
540919|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
540920|NCT00831415|E1|Reported Event|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
540921|NCT00831428|B1|Baseline|Scottish Swimming Team|
540922|NCT00831428|P1|Participant Flow|Scottish Swimming Team|
540923|NCT00831428|O1|Outcome|Scottish Swimming Team|
540924|NCT00831428|E1|Reported Event|Scottish Swimming Team|
540925|NCT00831441|B3|Baseline|Total|Total of all reporting groups
540926|NCT00831441|B2|Baseline|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily.
540927|NCT00831441|B1|Baseline|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540928|NCT00831441|P2|Participant Flow|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
540929|NCT00831441|P1|Participant Flow|Placebo BID|Placebo: Tablets, Oral, 0 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
540930|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
540931|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540932|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
540933|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540934|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
540935|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540936|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
540937|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540938|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
540939|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540940|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
540941|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540942|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
540943|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540944|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
540945|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540946|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
540947|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540948|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
540949|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540950|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
540951|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540952|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated in Year 2.
540953|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
540954|NCT00831441|E2|Reported Event|Placebo BID|Placebo: Tablets, Oral, 0 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
540955|NCT00831441|E1|Reported Event|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
540956|NCT00831480|B1|Baseline|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus
everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
540993|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
540957|NCT00831480|P1|Participant Flow|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus
everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
540958|NCT00831480|O1|Outcome|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus
everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
540959|NCT00831480|E1|Reported Event|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus
everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
540960|NCT00831493|B1|Baseline|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
540961|NCT00831493|P1|Participant Flow|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
540962|NCT00831493|O1|Outcome|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
540963|NCT00831493|E1|Reported Event|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
540964|NCT00825227|B3|Baseline|Total|Total of all reporting groups
540965|NCT00825227|B2|Baseline|Matching Placebo|"placebo
taxane chemotherapy treatment alone or in combination with other agents"
540966|NCT00825227|B1|Baseline|150 mg/Day Armodafinil|"150 mg/day armodafinil
taxane chemotherapy treatment alone or in combination with other agents"
540967|NCT00825227|P2|Participant Flow|Matching Placebo|"placebo
taxane chemotherapy treatment alone or in combination with other agents"
540968|NCT00825227|P1|Participant Flow|150 mg/Day Armodafinil|"150 mg/day armodafinil
taxane chemotherapy treatment alone or in combination with other agents"
540969|NCT00825227|O2|Outcome|Armodafinil 150 mg/Day|"150 mg/day armodafinil (3 tablets of 50 mg armodafinil)
taxane chemotherapy treatment alone or in combination with other agents"
540970|NCT00825227|O1|Outcome|Placebo|"Placebo (3 tablets matching armodafinil tablets)
taxane chemotherapy treatment alone or in combination with other agents"
540971|NCT00825227|E2|Reported Event|Matching Placebo|"placebo
taxane chemotherapy treatment alone or in combination with other agents"
540972|NCT00825227|E1|Reported Event|150 mg/Day Armodafinil|"150 mg/day armodafinil
taxane chemotherapy treatment alone or in combination with other agents"
540973|NCT00825266|B3|Baseline|Total|Total of all reporting groups
540974|NCT00825266|B2|Baseline|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.
Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
540975|NCT00825266|B1|Baseline|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.
bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
540976|NCT00825266|P2|Participant Flow|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.
Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
540977|NCT00825266|P1|Participant Flow|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.
bosentan: Bosentan 62.5 mg twice daily for 4 weeks, then 125mg BID for duration of study."
540978|NCT00825266|O2|Outcome|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.
Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
540979|NCT00825266|O1|Outcome|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.
bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
540980|NCT00825266|O2|Outcome|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.
Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
540981|NCT00825266|O1|Outcome|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.
bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
540982|NCT00825266|O2|Outcome|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.
Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
540983|NCT00825266|O1|Outcome|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.
bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
540984|NCT00825266|E2|Reported Event|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.
Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
540985|NCT00825266|E1|Reported Event|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.
bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
540986|NCT00825305|B3|Baseline|Total|Total of all reporting groups
540987|NCT00825305|B2|Baseline|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
540988|NCT00825305|B1|Baseline|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
540989|NCT00825305|P2|Participant Flow|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
540990|NCT00825305|P1|Participant Flow|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
540991|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
540992|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
540994|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
540995|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
540996|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
540997|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
540998|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
540999|NCT00825305|E2|Reported Event|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
541000|NCT00825305|E1|Reported Event|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
541001|NCT00825318|B1|Baseline|Daily Ultrafiltration|During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
541002|NCT00825318|P1|Participant Flow|Daily Ultrafiltration|During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
541003|NCT00825318|O3|Outcome|Return Phase|During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
541004|NCT00825318|O2|Outcome|Daily Ultrafiltration Phase|During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
541005|NCT00825318|O1|Outcome|Prestudy Phase|During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.
541006|NCT00825318|E3|Reported Event|Return Phase|During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
541007|NCT00825318|E2|Reported Event|Daily Ultrafiltration Phase|During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
541008|NCT00825318|E1|Reported Event|Prestudy Phase|During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.
541009|NCT00825344|B3|Baseline|Total|Total of all reporting groups
541010|NCT00825344|B2|Baseline|Group 2|"Subcutaneous saline preoperatively
Saline : Given subcutaneously preoperatively"
541011|NCT00825344|B1|Baseline|Group 1|"Etanercept 50 mg preoperatively
Etanercept : 50 mg subcutaenous preoperatively"
541012|NCT00825344|P2|Participant Flow|Saline|"Subcutaneous saline preoperatively
Saline : Given subcutaneously preoperatively"
541013|NCT00825344|P1|Participant Flow|Etanercept|"Etanercept 50 mg preoperatively
Etanercept : 50 mg subcutaenous preoperatively"
541014|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively
Saline : Given subcutaneously preoperatively"
541015|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively
Etanercept : 50 mg subcutaenous preoperatively"
541016|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively
Saline : Given subcutaneously preoperatively"
541017|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively
Etanercept : 50 mg subcutaenous preoperatively"
541018|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively
Saline : Given subcutaneously preoperatively"
541019|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively
Etanercept : 50 mg subcutaenous preoperatively"
541020|NCT00825344|E2|Reported Event|Group 2|"Subcutaneous saline preoperatively
Saline : Given subcutaneously preoperatively"
541021|NCT00825344|E1|Reported Event|Group 1|"Etanercept 50 mg preoperatively
Etanercept : 50 mg subcutaenous preoperatively"
541022|NCT00825500|B4|Baseline|Total|Total of all reporting groups
541023|NCT00825500|B3|Baseline|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose
Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
541024|NCT00825500|B2|Baseline|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose
Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
541025|NCT00825500|B1|Baseline|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)
Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
541026|NCT00825500|P3|Participant Flow|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose
Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
541027|NCT00825500|P2|Participant Flow|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose
Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
541028|NCT00825500|P1|Participant Flow|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)
Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
541029|NCT00825500|O3|Outcome|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose
Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
541030|NCT00825500|O2|Outcome|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose
Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
541031|NCT00825500|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)
Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
541032|NCT00825500|O3|Outcome|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose
Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
541033|NCT00825500|O2|Outcome|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose
Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
541034|NCT00825500|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)
Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
541035|NCT00825500|E3|Reported Event|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose
Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
541036|NCT00825500|E2|Reported Event|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose
Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
541037|NCT00825500|E1|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)
Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
541039|NCT00831675|B2|Baseline|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541040|NCT00831675|B1|Baseline|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541041|NCT00831675|P2|Participant Flow|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541042|NCT00831675|P1|Participant Flow|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541043|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541044|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541045|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541046|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541047|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541048|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541049|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541050|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541051|NCT00831675|E2|Reported Event|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541052|NCT00831675|E1|Reported Event|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
541053|NCT00831701|B3|Baseline|Total|Total of all reporting groups
541054|NCT00831701|B2|Baseline|Placebo Treatment|Patients received Placebo pill once daily
541055|NCT00831701|B1|Baseline|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
541056|NCT00831701|P2|Participant Flow|Placebo Treatment|Patients received Placebo pill once daily
541057|NCT00831701|P1|Participant Flow|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
541058|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
541059|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
541060|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
541061|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
541062|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
541063|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
541064|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
541065|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
541066|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
541067|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
541068|NCT00831701|E2|Reported Event|Placebo Treatment|Patients received Placebo pill once daily
541069|NCT00831701|E1|Reported Event|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
541070|NCT00831753|B3|Baseline|Total|Total of all reporting groups
541071|NCT00831753|B2|Baseline|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
541072|NCT00831753|B1|Baseline|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
541073|NCT00831753|P2|Participant Flow|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
541074|NCT00831753|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
541075|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
541076|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
541196|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
541077|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
541078|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
541079|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
541080|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
541081|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
541082|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
541083|NCT00831753|E2|Reported Event|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
541084|NCT00831753|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
541085|NCT00831766|B3|Baseline|Total|Total of all reporting groups
541086|NCT00831766|B2|Baseline|Phase II: Treatment at MTD|"Idarubicin: 12 mg/m^2.
Cytarabine: 200 mg/m^2.
Lenalidomide: Maximum Tolerated Dose (MTD).
Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
541087|NCT00831766|B1|Baseline|Phase I: Dose Escalation|"Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.
Idarubicin: 12 mg/m^2.
Cytarabine: 200 mg/m^2.
Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.
Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
541088|NCT00831766|P2|Participant Flow|Phase II: Treatment at MTD|"Idarubicin: 12 mg/m^2.
Cytarabine: 200 mg/m^2.
Lenalidomide: Maximum Tolerated Dose (MTD).
Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
541089|NCT00831766|P1|Participant Flow|Phase I: Dose Escalation|"Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.
Idarubicin: 12 mg/m^2.
Cytarabine: 200 mg/m^2.
Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.
Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
541090|NCT00831766|O1|Outcome|All Participants Treated at MTD|All participants, regardless of Phase who were treated at the maximum tolerated dose (MTD).
541091|NCT00831766|O1|Outcome|Phase I Participants|Dose escalation group.
541092|NCT00831766|E2|Reported Event|Phase II: Treatment at MTD|Participants enrolled during Phase II.
541093|NCT00831766|E1|Reported Event|Phase I: Dose Escalation|Participants enrolled during Phase I.
541094|NCT00831779|B3|Baseline|Total|Total of all reporting groups
541095|NCT00831779|B2|Baseline|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
541096|NCT00831779|B1|Baseline|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
541097|NCT00831779|P2|Participant Flow|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
541098|NCT00831779|P1|Participant Flow|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
541099|NCT00831779|O2|Outcome|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
541100|NCT00831779|O1|Outcome|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
541101|NCT00831779|O2|Outcome|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
541102|NCT00831779|O1|Outcome|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
541103|NCT00831779|E2|Reported Event|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
541104|NCT00831779|E1|Reported Event|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
541105|NCT00831844|B11|Baseline|Total|Total of all reporting groups
541197|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
541499|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541106|NCT00831844|B10|Baseline|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541107|NCT00831844|B9|Baseline|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541108|NCT00831844|B8|Baseline|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541109|NCT00831844|B7|Baseline|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541110|NCT00831844|B6|Baseline|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541111|NCT00831844|B5|Baseline|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541112|NCT00831844|B4|Baseline|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541113|NCT00831844|B3|Baseline|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541114|NCT00831844|B2|Baseline|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541115|NCT00831844|B1|Baseline|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541116|NCT00831844|P10|Participant Flow|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541117|NCT00831844|P9|Participant Flow|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541118|NCT00831844|P8|Participant Flow|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541119|NCT00831844|P7|Participant Flow|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541120|NCT00831844|P6|Participant Flow|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541121|NCT00831844|P5|Participant Flow|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541122|NCT00831844|P4|Participant Flow|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541123|NCT00831844|P3|Participant Flow|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541198|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
541124|NCT00831844|P2|Participant Flow|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541125|NCT00831844|P1|Participant Flow|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541126|NCT00831844|O10|Outcome|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541127|NCT00831844|O9|Outcome|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541128|NCT00831844|O8|Outcome|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541129|NCT00831844|O7|Outcome|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541130|NCT00831844|O6|Outcome|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541131|NCT00831844|O5|Outcome|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541132|NCT00831844|O4|Outcome|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541133|NCT00831844|O3|Outcome|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541134|NCT00831844|O2|Outcome|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541135|NCT00831844|O1|Outcome|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541136|NCT00831844|E10|Reported Event|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541137|NCT00831844|E9|Reported Event|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541138|NCT00831844|E8|Reported Event|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541139|NCT00831844|E7|Reported Event|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541140|NCT00831844|E6|Reported Event|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541141|NCT00831844|E5|Reported Event|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541199|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
541500|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541142|NCT00831844|E4|Reported Event|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541143|NCT00831844|E3|Reported Event|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541144|NCT00831844|E2|Reported Event|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541145|NCT00831844|E1|Reported Event|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
laboratory biomarker analysis: Correlative studies"
541146|NCT00832819|B4|Baseline|Total|Total of all reporting groups
541147|NCT00832819|B3|Baseline|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
541148|NCT00832819|B2|Baseline|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
541149|NCT00832819|B1|Baseline|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (Area under the curve (AUC) 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
541150|NCT00832819|P3|Participant Flow|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
541151|NCT00832819|P2|Participant Flow|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
541152|NCT00832819|P1|Participant Flow|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
541153|NCT00832819|O1|Outcome|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
541154|NCT00832819|E3|Reported Event|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
541155|NCT00832819|E2|Reported Event|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
541156|NCT00832819|E1|Reported Event|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
541157|NCT00832871|B1|Baseline|Mifepristone|"200 mg RU-486 (Mifepristone) daily
Mifepristone: Mifepristone 200 mg will be administered orally"
541158|NCT00832871|P1|Participant Flow|Mifepristone|"200 mg RU-486 (Mifepristone) daily
Mifepristone: Mifepristone 200 mg will be administered orally"
541159|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily
Mifepristone: Mifepristone 200 mg will be administered orally"
541160|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily
Mifepristone: Mifepristone 200 mg will be administered orally"
541161|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily
Mifepristone: Mifepristone 200 mg will be administered orally"
541162|NCT00832871|E1|Reported Event|Mifepristone|"200 mg RU-486 (Mifepristone) daily
Mifepristone: Mifepristone 200 mg will be administered orally"
541163|NCT00832975|B1|Baseline|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
541164|NCT00832975|P1|Participant Flow|St Jude Medical ICD/CRT-D|St Jude Medical Implantable Cardioverter Defibrillator (ICD) / Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Device implanted patients
541165|NCT00832975|O1|Outcome|Single Arm|St Jude Medical ICD/CRT-D Device implanted patients
541166|NCT00832975|O1|Outcome|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
541167|NCT00832975|E1|Reported Event|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
541173|NCT00833040|B1|Baseline|Sufentanil Followed by Sufentanil and PBO|"During the Titration Phase, patients titrated to the effective dosage of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken as needed for breakthrough pain.
During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of which included seven active (dosage determined in Titration Phase) and three placebo doses taken in random order per. One NanoTab™ was taken as needed for breakthrough pain."
541174|NCT00833040|P6|Participant Flow|Sequence 6|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 6 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 10th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
541175|NCT00833040|P5|Participant Flow|Sequence 5|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 5 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
541176|NCT00833040|P4|Participant Flow|Sequence 4|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 4 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 5th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
541177|NCT00833040|P3|Participant Flow|Sequence 3|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 3 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 5th, and 9th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
541178|NCT00833040|P2|Participant Flow|Sequence 2|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 2 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
541179|NCT00833040|P1|Participant Flow|Sequence 1|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.
Double-Blind Phase/Sequence 1 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
541180|NCT00833040|O2|Outcome|Double Blind Phase of 3 Pbo Tablets|Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
541181|NCT00833040|O1|Outcome|Double Blind Phase of 7 Sufentanil Tablets|Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
541182|NCT00833040|E1|Reported Event|Titration of Sufentanil Followed by Sufentanil and PBO|"During the Titration Phase, patients titrated to their personal effective strength of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken for each episode of breakthrough pain.
During the Double-Blind Phase, patients were randomized to one of six treatment sequences, each of which included seven active doses (the strength determined in Titration Phase) and three placebo doses. The ten doses were in random order. One NanoTab™ was taken for each episode of breakthrough pain."
541183|NCT00833053|B3|Baseline|Total|Total of all reporting groups
541184|NCT00833053|B2|Baseline|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
541185|NCT00833053|B1|Baseline|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
541186|NCT00833053|P2|Participant Flow|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
541187|NCT00833053|P1|Participant Flow|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
541188|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
541189|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
541190|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
541191|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
541192|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
541193|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
541194|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
541195|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
552230|NCT00852917|E4|Reported Event|4: Placebo|
541200|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
541201|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
541202|NCT00833053|E2|Reported Event|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
541203|NCT00833053|E1|Reported Event|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
541204|NCT00833092|B3|Baseline|Total|Total of all reporting groups
541205|NCT00833092|B2|Baseline|Magnesium|300 milligrams of magnesium daily
541206|NCT00833092|B1|Baseline|Sugar Pill|zero magnesium supplementation
541207|NCT00833092|P2|Participant Flow|Magnesium|300 milligrams of magnesium daily
541208|NCT00833092|P1|Participant Flow|Sugar Pill|zero magnesium supplementation
541209|NCT00833092|O2|Outcome|Magnesium|300 milligrams of magnesium daily
541210|NCT00833092|O1|Outcome|Sugar Pill|zero magnesium supplementation
541211|NCT00833092|E2|Reported Event|Magnesium|300 milligrams of magnesium daily
541212|NCT00833092|E1|Reported Event|Sugar Pill|zero magnesium supplementation
541213|NCT00833248|B3|Baseline|Total|Total of all reporting groups
541214|NCT00833248|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541215|NCT00833248|B1|Baseline|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541216|NCT00833248|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541217|NCT00833248|P1|Participant Flow|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541218|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541219|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541220|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541221|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541222|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541223|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541224|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541225|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541226|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541227|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541501|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541228|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541229|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541230|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541231|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541232|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541233|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541234|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541235|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541236|NCT00833248|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
541237|NCT00833248|E1|Reported Event|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
541238|NCT00833365|B3|Baseline|Total|Total of all reporting groups
541239|NCT00833365|B2|Baseline|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.
Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
541240|NCT00833365|B1|Baseline|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
541241|NCT00833365|P2|Participant Flow|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.
Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
541242|NCT00833365|P1|Participant Flow|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
541243|NCT00833365|O2|Outcome|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.
Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
541244|NCT00833365|O1|Outcome|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
541245|NCT00833365|O2|Outcome|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.
Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
541246|NCT00833365|O1|Outcome|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
541247|NCT00833365|E2|Reported Event|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.
Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
541248|NCT00833365|E1|Reported Event|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
541249|NCT00833417|B3|Baseline|Total|Total of all reporting groups
541250|NCT00833417|B2|Baseline|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541251|NCT00833417|B1|Baseline|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541252|NCT00833417|P2|Participant Flow|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541253|NCT00833417|P1|Participant Flow|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541254|NCT00833417|O1|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541255|NCT00833417|O1|Outcome|Metastatic and Locally Advanced BCC Cohorts|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541256|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541257|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541258|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541259|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541260|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541261|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541262|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541263|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541264|NCT00833417|E1|Reported Event|Metastatic and Locally Advanced BCC Cohorts|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
541265|NCT00833443|B3|Baseline|Total|Total of all reporting groups
541266|NCT00833443|B2|Baseline|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
541267|NCT00833443|B1|Baseline|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
541268|NCT00833443|P2|Participant Flow|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
541269|NCT00833443|P1|Participant Flow|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
541270|NCT00833443|O2|Outcome|NOT Medication Adherent|Participants in the bupropion group with a week 6 bupropion/hydroxybupropion plasma levels suggesting medication NON-adherence
541271|NCT00833443|O1|Outcome|Medication Adherent|Participants in the bupropion group with a week 6 bupropion/hydroxybupropion plasma levels suggesting medication adherence
541290|NCT00833482|P5|Participant Flow|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
541380|NCT00833586|B1|Baseline|Terbinafine (Test) First|Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
541272|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
541273|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
541274|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
541275|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
541276|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
541277|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
541278|NCT00833443|E2|Reported Event|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
541279|NCT00833443|E1|Reported Event|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.
Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
541280|NCT00833469|B1|Baseline|Escitalopram|"Flexible dose escitalopram 10mg
Escitalopram: Once daily by mouth"
541281|NCT00833469|P1|Participant Flow|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
541282|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
541283|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
541284|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
541285|NCT00833469|E1|Reported Event|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
541286|NCT00833482|B3|Baseline|Total|Total of all reporting groups
541287|NCT00833482|B2|Baseline|Poor Metabolizers (PM)|Participants without a functional CYP2C19 allele (poor metabolizers, or PM).
541288|NCT00833482|B1|Baseline|Extensive Metabolizers (EM)|Participants with functional CYP2C19 alleles (extensive metabolizers, or EM).
541289|NCT00833482|P6|Participant Flow|Atazanavir/Ritonavir, 300/100 QD (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541291|NCT00833482|P4|Participant Flow|Voriconazole, 50 mg BID (PM)|Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541292|NCT00833482|P3|Participant Flow|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541293|NCT00833482|P2|Participant Flow|Atazanavir/Ritonavir, 300/100 QD (EM)|EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541294|NCT00833482|P1|Participant Flow|Voriconazole, 200 BID (EM)|Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541295|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541296|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
541297|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541298|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541299|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541300|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541301|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541302|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
541303|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541304|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541305|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541306|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541307|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541308|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
541309|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541310|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541311|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541312|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541313|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541314|NCT00833482|O5|Outcome|Atazanavir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
541315|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM) received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541497|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541316|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541317|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541318|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541319|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541320|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
541321|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM) received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541322|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541323|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541324|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541325|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541326|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541327|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541328|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541329|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mg QD + Voriconazole, 200 mg BID|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541330|NCT00833482|O1|Outcome|Voriconazole, 200 BID|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541331|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541332|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541333|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541334|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541335|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541336|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541337|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541338|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EMs received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541339|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541340|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541341|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541342|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541343|NCT00833482|E6|Reported Event|Atazanazvir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
541344|NCT00833482|E5|Reported Event|Voriconazole, 50 mg BID (PM)|Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541345|NCT00833482|E4|Reported Event|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
541346|NCT00833482|E3|Reported Event|Atazanavir/Ritonavir, 300/100 QD (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
541347|NCT00833482|E2|Reported Event|Atazanavir/Ritonavir, 300/100 QD (EM)|EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal
541348|NCT00833482|E1|Reported Event|Voriconazole, 200 BID (EM)|Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
541349|NCT00833521|B3|Baseline|Total|Total of all reporting groups
541350|NCT00833521|B2|Baseline|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
541351|NCT00833521|B1|Baseline|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
541352|NCT00833521|P2|Participant Flow|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
541353|NCT00833521|P1|Participant Flow|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
541354|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
541355|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
541356|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
541357|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
541358|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
541359|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
541360|NCT00833547|B3|Baseline|Total|Total of all reporting groups
541361|NCT00833547|B2|Baseline|Placebo|placebo capsule that looks identical to eszopiclone at bedtime on 2 consecutive nights
541362|NCT00833547|B1|Baseline|Eszopiclone|3mg of eszopiclone at bedtime on 2 consecutive nights
541363|NCT00833547|P2|Participant Flow|Eszopiclone|3mg of eszopiclone at bedtime for two consecutive nights
541364|NCT00833547|P1|Participant Flow|Placebo|placebo capsules that appear identical to eszopiclone capsules on 2 consecutive nights
541365|NCT00833547|O2|Outcome|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
541366|NCT00833547|O1|Outcome|Eszopiclone|3mg of eszopiclone on two consecutive nights
541367|NCT00833547|O2|Outcome|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
541368|NCT00833547|O1|Outcome|Eszopiclone|3mg of eszopiclone on two consecutive nights
541369|NCT00833547|E2|Reported Event|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
541370|NCT00833547|E1|Reported Event|Eszopiclone|3mg of eszopiclone on two consecutive nights
541371|NCT00833560|B1|Baseline|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
541372|NCT00833560|P1|Participant Flow|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
541373|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
541374|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
541375|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
541376|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
541377|NCT00833560|E1|Reported Event|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
541378|NCT00833586|B3|Baseline|Total|Total of all reporting groups
541379|NCT00833586|B2|Baseline|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
541381|NCT00833586|P2|Participant Flow|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
541382|NCT00833586|P1|Participant Flow|Terbinafine (Test) First|Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
541383|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
541384|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
541385|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
541386|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
541387|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
541388|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
541389|NCT00833638|B4|Baseline|Total|Total of all reporting groups
541390|NCT00833638|B3|Baseline|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
541391|NCT00833638|B2|Baseline|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541392|NCT00833638|B1|Baseline|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541393|NCT00833638|P3|Participant Flow|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
541394|NCT00833638|P2|Participant Flow|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541395|NCT00833638|P1|Participant Flow|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541396|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541397|NCT00833638|O1|Outcome|Tadalafil 2.5 mg Double-blind|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541398|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541399|NCT00833638|O1|Outcome|Tadalafil 5 mg Double-blind|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541400|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541401|NCT00833638|O1|Outcome|Tadalafil 2.5 mg Double-blind|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541402|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541403|NCT00833638|O1|Outcome|Placebo Double-blind|No drug during baseline period, placeob for 14 days, then will continue at 5 mg for 14 days.
541404|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
541405|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541406|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541407|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
541408|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541409|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541410|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
541411|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541412|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541413|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
541414|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541415|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541416|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
541417|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541418|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541419|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
541420|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541421|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541422|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
541423|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541424|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541425|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
541426|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
541427|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
541428|NCT00833638|E6|Reported Event|Placebo to Tadalafil 5 mg|Participants receiving open-label tadalafil 5 mg after receiving placebo in the double-blind period.
541429|NCT00833638|E5|Reported Event|Tadalafil 5 mg to Tadalafil 5 mg|Participants receiving open-label tadalafil 5 mg after receiving tadalafil 5 mg in the double-blind period.
541430|NCT00833638|E4|Reported Event|Tadalafil 2.5 mg to Tadalafil 5 mg|Participants receiving tadalafil 5 mg in the open-label period after receiving tadalafil 2.5 mg in the double-blind period.
541431|NCT00833638|E3|Reported Event|Placebo|No drug during baseline period followed by placebo for 14 days.
541432|NCT00833638|E2|Reported Event|Tadalafil 5 mg|No drug during baseline period followed by tadalafil 5 mg for 14 days.
541433|NCT00833638|E1|Reported Event|Tadalafil 2.5 mg|No drug during baseline period followed by tadalafil 2.5 mg for 14 days.
541434|NCT00833664|B3|Baseline|Total|Total of all reporting groups
541435|NCT00833664|B2|Baseline|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
541436|NCT00833664|B1|Baseline|Terbinafine (Test) First|Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
541437|NCT00833664|P2|Participant Flow|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
541438|NCT00833664|P1|Participant Flow|Terbinafine (Test) First|Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
541439|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
541440|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
541441|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
541442|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
541443|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
541444|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
541445|NCT00833690|B4|Baseline|Total|Total of all reporting groups
541446|NCT00833690|B3|Baseline|[C.]Moderate|Inosine to produce a moderate urate elevation
541447|NCT00833690|B2|Baseline|[B:]Mild|Inosine to produce a mild urate elevation
541448|NCT00833690|B1|Baseline|[A:]Placebo|Placebo to produce no urate elevation
541449|NCT00833690|P3|Participant Flow|[C.]Moderate|Inosine to produce a moderate urate elevation
541450|NCT00833690|P2|Participant Flow|[B:]Mild|Inosine to produce a mild urate elevation
541451|NCT00833690|P1|Participant Flow|[A:]Placebo|Placebo to produce no urate elevation
541452|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541453|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541454|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541455|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541456|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541457|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541458|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541459|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541460|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541461|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541462|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541463|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541464|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541465|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541466|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541467|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541468|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541469|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541470|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541471|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541472|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541473|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541474|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541475|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541476|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541477|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541478|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541479|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541480|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541481|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541482|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541483|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541484|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541485|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541486|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541487|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541488|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541489|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541490|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541491|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541492|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541493|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541494|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541495|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541496|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541502|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541503|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541504|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541505|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541506|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541507|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541508|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541509|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541510|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541511|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541512|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541513|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541514|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541515|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541516|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541517|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541518|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541519|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541520|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541521|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541522|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541523|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541524|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541525|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541526|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541527|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541528|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541529|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541530|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541531|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541532|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541533|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541534|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541535|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541536|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541537|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541538|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541539|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541540|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541541|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541542|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541543|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541544|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541545|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541546|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541547|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541548|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541549|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541550|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541551|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541552|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541553|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541554|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541555|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541556|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541557|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541558|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541559|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541560|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541561|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541562|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541563|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541564|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541565|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541566|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
541567|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
541568|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
541569|NCT00833690|E3|Reported Event|[C.]Moderate|Inosine to produce a moderate urate elevation
541570|NCT00833690|E2|Reported Event|[B:]Mild|Inosine to produce a mild urate elevation
541571|NCT00833690|E1|Reported Event|[A:]Placebo|Placebo to produce no urate elevation
541572|NCT00833703|B3|Baseline|Total|Total of all reporting groups
541573|NCT00833703|B2|Baseline|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
541574|NCT00833703|B1|Baseline|Placebo|0.2 mL/kg/day matching placebo solution once daily
541575|NCT00833703|P2|Participant Flow|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
541576|NCT00833703|P1|Participant Flow|Placebo|0.2 mL/kg/day matching placebo solution once daily
541577|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
541578|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
541579|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
541580|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
541581|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
541582|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
541583|NCT00833703|E2|Reported Event|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
541584|NCT00833703|E1|Reported Event|Placebo|0.2 mL/kg/day matching placebo solution once daily
541585|NCT00833755|B5|Baseline|Total|Total of all reporting groups
541586|NCT00833755|B4|Baseline|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
541587|NCT00833755|B3|Baseline|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
541588|NCT00833755|B2|Baseline|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
541589|NCT00833755|B1|Baseline|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
541590|NCT00833755|P4|Participant Flow|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
541591|NCT00833755|P3|Participant Flow|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
541592|NCT00833755|P2|Participant Flow|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
541593|NCT00833755|P1|Participant Flow|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
541594|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
541595|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
541596|NCT00833755|O2|Outcome|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
541597|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
541598|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
541599|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
541600|NCT00833755|O2|Outcome|Opioid - Placebo|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
541601|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
541602|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
541603|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
541604|NCT00833755|O2|Outcome|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
541605|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
541606|NCT00833755|E4|Reported Event|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
541607|NCT00833755|E3|Reported Event|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
541608|NCT00833755|E2|Reported Event|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
541609|NCT00833755|E1|Reported Event|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
541610|NCT00833781|B3|Baseline|Total|Total of all reporting groups
541611|NCT00833781|B2|Baseline|Autologous Dendritic Cells Without Transfected mRNA.|"Dendritic cell vaccine without transfected mRNA.
Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10."
541789|NCT00834041|P1|Participant Flow|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
541612|NCT00833781|B1|Baseline|mRNA-transfected Autologous Dendritic Cell Vaccine.|mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
541613|NCT00833781|P2|Participant Flow|Autologous Dendritic Cells Without Transfected mRNA.|"Dendritic cell vaccine without transfected mRNA.
Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10."
541614|NCT00833781|P1|Participant Flow|mRNA-transfected Autologous Dendritic Cell Vaccine.|mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
541615|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
541616|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
541617|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
541618|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
541619|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
541620|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
541621|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
541622|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
541623|NCT00833781|E1|Reported Event|mRNA Transfected DCs|
541624|NCT00833794|B3|Baseline|Total|Total of all reporting groups
541625|NCT00833794|B2|Baseline|2 Placebo|
541626|NCT00833794|B1|Baseline|1 Tramadol Once A Day|
541627|NCT00833794|P2|Participant Flow|2 Placebo|
541628|NCT00833794|P1|Participant Flow|1 Tramadol Once A Day|
541629|NCT00833794|O2|Outcome|2 Placebo|
541630|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
541631|NCT00833794|O2|Outcome|2 Placebo|
541632|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
541633|NCT00833794|O2|Outcome|2 Placebo|
541634|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
541635|NCT00833794|O2|Outcome|2 Placebo|
541636|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
541637|NCT00833794|O2|Outcome|2 Placebo|
541638|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
541639|NCT00833794|O2|Outcome|2 Placebo|
541640|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
541641|NCT00833794|O2|Outcome|2 Placebo|
541642|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
541643|NCT00833794|O4|Outcome|Tramadol Once A Day 300 mg|
541644|NCT00833794|O3|Outcome|Tramadol Once A Day 200 mg|
541645|NCT00833794|O2|Outcome|2 Placebo|
541646|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
541647|NCT00833794|O2|Outcome|2 Placebo|
541648|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
541649|NCT00833794|O2|Outcome|2 Placebo|
541650|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
541651|NCT00833794|E2|Reported Event|2 Placebo|
541652|NCT00833794|E1|Reported Event|1 Tramadol Once A Day|
541653|NCT00833833|B7|Baseline|Total|Total of all reporting groups
541654|NCT00833833|B6|Baseline|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
541655|NCT00833833|B5|Baseline|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
541656|NCT00833833|B4|Baseline|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541657|NCT00833833|B3|Baseline|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541658|NCT00833833|B2|Baseline|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541659|NCT00833833|B1|Baseline|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541660|NCT00833833|P6|Participant Flow|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
541661|NCT00833833|P5|Participant Flow|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
541662|NCT00833833|P4|Participant Flow|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541663|NCT00833833|P3|Participant Flow|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541664|NCT00833833|P2|Participant Flow|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541665|NCT00833833|P1|Participant Flow|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541837|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
541666|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
541667|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
541668|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
541669|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
541670|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
541671|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
541672|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
541673|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
541674|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
541675|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
541676|NCT00833833|O4|Outcome|Phase 2: Pomalidomide (Overall)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone."
541677|NCT00833833|O3|Outcome|Phase 2: Pomalidomide (Pom + Dex Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone."
541678|NCT00833833|O2|Outcome|Phase 2: Pomalidomide (Pom Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added."
541679|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
541680|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541681|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541682|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541683|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541684|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541685|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541686|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541687|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541688|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
541689|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
541690|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541718|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541691|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541692|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541693|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541694|NCT00833833|E8|Reported Event|Phase 2: Pomalidomide (Overall)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.
Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone."
541695|NCT00833833|E7|Reported Event|Phase 2: Pomalidomide (Pom + Dex Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.
Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone."
541696|NCT00833833|E6|Reported Event|Phase 2: Pomalidomide (Pom Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.
Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added."
541697|NCT00833833|E5|Reported Event|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
541698|NCT00833833|E4|Reported Event|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541699|NCT00833833|E3|Reported Event|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541700|NCT00833833|E2|Reported Event|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541701|NCT00833833|E1|Reported Event|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
541702|NCT00833859|B1|Baseline|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
541703|NCT00833859|P1|Participant Flow|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
541704|NCT00833859|O1|Outcome|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
541705|NCT00833859|E1|Reported Event|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
541706|NCT00833898|B3|Baseline|Total|Total of all reporting groups
541707|NCT00833898|B2|Baseline|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541708|NCT00833898|B1|Baseline|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541709|NCT00833898|P2|Participant Flow|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541710|NCT00833898|P1|Participant Flow|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541711|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541712|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541713|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541714|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541715|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541716|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541717|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541787|NCT00834041|B1|Baseline|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
541719|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541720|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541721|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541722|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541723|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541724|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541725|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541726|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541727|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541728|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541729|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541730|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541731|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541732|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541733|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541734|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541735|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541736|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541737|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541738|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541739|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541740|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541741|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541742|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541743|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541744|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541745|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541746|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541788|NCT00834041|P2|Participant Flow|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
541838|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
541747|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541748|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541749|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541750|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541751|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541752|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541753|NCT00833898|E2|Reported Event|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
541754|NCT00833898|E1|Reported Event|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
541755|NCT00833911|B1|Baseline|300 mg Tramadol HCl OAD|
541756|NCT00833911|P1|Participant Flow|300 mg Tramadol HCl OAD|
541757|NCT00833911|O3|Outcome|12-months Safety|
541758|NCT00833911|O2|Outcome|6-months Safety|
541759|NCT00833911|O1|Outcome|All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum|All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
541760|NCT00833911|E3|Reported Event|12-months Safety|
541761|NCT00833911|E2|Reported Event|6-months Safety|
541762|NCT00833911|E1|Reported Event|All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum|All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
541763|NCT00833924|B1|Baseline|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
541764|NCT00833924|P1|Participant Flow|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
541765|NCT00833924|O1|Outcome|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
541766|NCT00833924|O1|Outcome|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
541767|NCT00833924|E1|Reported Event|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
541768|NCT00833937|B3|Baseline|Total|Total of all reporting groups
541769|NCT00833937|B2|Baseline|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
541770|NCT00833937|B1|Baseline|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
541771|NCT00833937|P2|Participant Flow|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
541772|NCT00833937|P1|Participant Flow|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
541773|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
541774|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
541775|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
541776|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
541777|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
541778|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
541779|NCT00833976|B1|Baseline|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks
Lovaza: 4 grams per day"
541780|NCT00833976|P1|Participant Flow|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks
Lovaza: 4 grams per day"
541781|NCT00833976|O1|Outcome|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks
Lovaza: 4 grams per day"
541782|NCT00833976|O1|Outcome|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks
Lovaza: 4 grams per day"
541783|NCT00833976|O1|Outcome|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks
Lovaza: 4 grams per day"
541784|NCT00833976|E1|Reported Event|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks
Lovaza: 4 grams per day"
541785|NCT00834041|B3|Baseline|Total|Total of all reporting groups
541786|NCT00834041|B2|Baseline|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
541790|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
541791|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
541792|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
541793|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
541794|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
541795|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
541796|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
541797|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
541798|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
541799|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
541800|NCT00834041|E2|Reported Event|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
541801|NCT00834041|E1|Reported Event|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
541802|NCT00834067|B3|Baseline|Total|Total of all reporting groups
541803|NCT00834067|B2|Baseline|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in the second period.
541804|NCT00834067|B1|Baseline|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
541805|NCT00834067|P2|Participant Flow|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in the second period.
541806|NCT00834067|P1|Participant Flow|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
541807|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
541808|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
541809|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
541810|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
541811|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
541812|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
541813|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
541814|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
541815|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
541816|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
541817|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
541818|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
541819|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
541820|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
541821|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
541822|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
541823|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
541824|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
541825|NCT00834080|B1|Baseline|VIVITROL, 380mg|
541826|NCT00834080|P1|Participant Flow|VIVITROL|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
541827|NCT00834080|O1|Outcome|VIVITROL|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
541828|NCT00834080|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
541829|NCT00834132|B3|Baseline|Total|Total of all reporting groups
541830|NCT00834132|B2|Baseline|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
541831|NCT00834132|B1|Baseline|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
541832|NCT00834132|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
541833|NCT00834132|P1|Participant Flow|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
541834|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
541835|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
541836|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
541839|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
541840|NCT00834171|B3|Baseline|Total|Total of all reporting groups
541841|NCT00834171|B2|Baseline|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
541842|NCT00834171|B1|Baseline|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
541843|NCT00834171|P2|Participant Flow|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
541844|NCT00834171|P1|Participant Flow|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
541845|NCT00834171|O2|Outcome|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
541846|NCT00834171|O1|Outcome|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
541847|NCT00834171|E2|Reported Event|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
541848|NCT00834171|E1|Reported Event|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
541849|NCT00834197|B3|Baseline|Total|Total of all reporting groups
541850|NCT00834197|B2|Baseline|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
541851|NCT00834197|B1|Baseline|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
541852|NCT00834197|P2|Participant Flow|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
541853|NCT00834197|P1|Participant Flow|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
541854|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
541855|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
541856|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
541857|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
541858|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
541859|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
541860|NCT00834210|B3|Baseline|Total|Total of all reporting groups
541861|NCT00834210|B2|Baseline|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
541862|NCT00834210|B1|Baseline|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
541863|NCT00834210|P2|Participant Flow|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
541864|NCT00834210|P1|Participant Flow|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
541865|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
541866|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
541867|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
541868|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
541869|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
541870|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
541871|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
541872|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
541873|NCT00834210|E2|Reported Event|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
541874|NCT00834210|E1|Reported Event|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
541875|NCT00834236|B3|Baseline|Total|Total of all reporting groups
541876|NCT00834236|B2|Baseline|Normal Subject|"healthy subject
normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
541877|NCT00834236|B1|Baseline|Gastric Cancer|"gastric cancer patients
normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
541878|NCT00834236|P2|Participant Flow|Normal Subject|"healthy subject
normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
541879|NCT00834236|P1|Participant Flow|Gastric Cancer|"gastric cancer patients
normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
541880|NCT00834236|O2|Outcome|Normal Subject|"healthy subject
normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
541881|NCT00834236|O1|Outcome|Gastric Cancer|"gastric cancer patients
normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
541882|NCT00834236|E2|Reported Event|Normal Subject|"healthy subject
normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
541883|NCT00834236|E1|Reported Event|Gastric Cancer|"gastric cancer patients
normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
541884|NCT00834249|B3|Baseline|Total|Total of all reporting groups
541885|NCT00834249|B2|Baseline|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
541886|NCT00834249|B1|Baseline|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
541887|NCT00834249|P2|Participant Flow|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
541888|NCT00834249|P1|Participant Flow|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
541889|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
541890|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
541891|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
541892|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
541893|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
541894|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
541895|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
541896|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
541897|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
541898|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
541899|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
541900|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
541901|NCT00834275|B3|Baseline|Total|Total of all reporting groups
541902|NCT00834275|B2|Baseline|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
541903|NCT00834275|B1|Baseline|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
541904|NCT00834275|P2|Participant Flow|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
541905|NCT00834275|P1|Participant Flow|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
541906|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
541907|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
541908|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
541909|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
541910|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
541911|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
541912|NCT00834288|B3|Baseline|Total|Total of all reporting groups
541913|NCT00834288|B2|Baseline|Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First|1 x 50 mg Tramadol HCl IR (Ultram®) Tablet 6-Hourly reference product dosed in first period followed by Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II). IR = Immediate Release.
541914|NCT00834288|B1|Baseline|Test (Tramadol HCl OAD 200 mg) First|1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
541915|NCT00834288|P2|Participant Flow|Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First|"1 x 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.
IR = Immediate Release."
541916|NCT00834288|P1|Participant Flow|Test (Tramadol HCl OAD 200 mg) First|1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
541917|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
541918|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
541919|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
541920|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
541921|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
541922|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
541923|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
541924|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
541925|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
541926|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
541927|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
541928|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
541929|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
541930|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
541931|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
541932|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
541933|NCT00834288|E2|Reported Event|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
541934|NCT00834288|E1|Reported Event|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
541935|NCT00834340|B3|Baseline|Total|Total of all reporting groups
541936|NCT00834340|B2|Baseline|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
541937|NCT00834340|B1|Baseline|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
541938|NCT00834340|P2|Participant Flow|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
541939|NCT00834340|P1|Participant Flow|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
541940|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
541941|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
541942|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
541943|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
541944|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
541945|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
541946|NCT00834366|B3|Baseline|Total|Total of all reporting groups
541947|NCT00834366|B2|Baseline|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
541948|NCT00834366|B1|Baseline|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
541949|NCT00834366|P2|Participant Flow|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
541950|NCT00834366|P1|Participant Flow|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
541951|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
541952|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
541953|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
541954|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
541955|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
541956|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
541957|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
541958|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
541959|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
541960|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
541961|NCT00834366|E2|Reported Event|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
541962|NCT00834366|E1|Reported Event|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
541963|NCT00834405|B3|Baseline|Total|Total of all reporting groups
541964|NCT00834405|B2|Baseline|Arava®|Arava® 20 mg Tablet
541965|NCT00834405|B1|Baseline|Leflunomide|Leflunomide 20 mg Tablet
541966|NCT00834405|P2|Participant Flow|Arava®|Arava® 20 mg Tablet
541967|NCT00834405|P1|Participant Flow|Leflunomide|Leflunomide 20 mg Tablet
541968|NCT00834405|O2|Outcome|Arava®|Arava® 20 mg Tablet
541969|NCT00834405|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
541970|NCT00834405|O2|Outcome|Arava®|Arava® 20 mg Tablet
541971|NCT00834405|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
541972|NCT00834418|B3|Baseline|Total|Total of all reporting groups
541973|NCT00834418|B2|Baseline|Arava™|Arava™ 20 mg Tablet
541974|NCT00834418|B1|Baseline|Leflunomide|Leflunomide 20 mg Tablet
541975|NCT00834418|P2|Participant Flow|Arava™|Arava™ 20 mg Tablet
541976|NCT00834418|P1|Participant Flow|Leflunomide|Leflunomide 20 mg Tablet
541977|NCT00834418|O2|Outcome|Arava™|Arava™ 20 mg Tablet
541978|NCT00834418|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
541979|NCT00834418|O2|Outcome|Arava™|Arava™ 20 mg Tablet
541980|NCT00834418|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
541981|NCT00834431|B3|Baseline|Total|Total of all reporting groups
541982|NCT00834431|B2|Baseline|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
541983|NCT00834431|B1|Baseline|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
541984|NCT00834431|P2|Participant Flow|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
541985|NCT00834431|P1|Participant Flow|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
541986|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
541987|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
541988|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
541989|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
541990|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
541991|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
541992|NCT00834444|B3|Baseline|Total|Total of all reporting groups
541993|NCT00834444|B2|Baseline|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
541994|NCT00834444|B1|Baseline|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
541995|NCT00834444|P2|Participant Flow|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
541996|NCT00834444|P1|Participant Flow|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
541997|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
541998|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
541999|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
542000|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
542001|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
542002|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
542003|NCT00834483|B3|Baseline|Total|Total of all reporting groups
542004|NCT00834483|B2|Baseline|Control Group|Layered traditional wound closure (monocryl)
542005|NCT00834483|B1|Baseline|Treatment Group|Knotless suture for wound closure
542006|NCT00834483|P2|Participant Flow|Control Group|Layered traditional wound closure (monocryl)
542007|NCT00834483|P1|Participant Flow|Treatment Group|Knotless suture for wound closure
542008|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
542009|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
542010|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
542011|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
542012|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
542013|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
542014|NCT00834483|E2|Reported Event|Control Group|Layered traditional wound closure (monocryl)
542015|NCT00834483|E1|Reported Event|Treatment Group|Knotless suture for wound closure
542016|NCT00834522|B3|Baseline|Total|Total of all reporting groups
542017|NCT00834522|B2|Baseline|Kytril® (Reference) First|Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
542018|NCT00834522|B1|Baseline|Granisetron (Test) First|Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
542019|NCT00834522|P2|Participant Flow|Kytril® (Reference) First|Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
542020|NCT00834522|P1|Participant Flow|Granisetron (Test) First|Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
542021|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
542022|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
542023|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
542024|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
542025|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
542026|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
542027|NCT00834535|B3|Baseline|Total|Total of all reporting groups
542028|NCT00834535|B2|Baseline|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
542029|NCT00834535|B1|Baseline|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
542030|NCT00834535|P2|Participant Flow|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
542031|NCT00834535|P1|Participant Flow|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
542032|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
542033|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
542034|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
542035|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
542036|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
542037|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
542038|NCT00834561|B3|Baseline|Total|Total of all reporting groups
542039|NCT00834561|B2|Baseline|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
542040|NCT00834561|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
542041|NCT00834561|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
542042|NCT00834561|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
542043|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
542044|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
542045|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
542046|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
542047|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
542048|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
542049|NCT00834574|B3|Baseline|Total|Total of all reporting groups
542050|NCT00834574|B2|Baseline|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period.
542051|NCT00834574|B1|Baseline|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
542052|NCT00834574|P2|Participant Flow|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period.
542053|NCT00834574|P1|Participant Flow|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
542054|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
542055|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
542056|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
542319|NCT00834990|B3|Baseline|Total|Total of all reporting groups
542057|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
542058|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
542059|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
542060|NCT00834587|B3|Baseline|Total|Total of all reporting groups
542061|NCT00834587|B2|Baseline|Metaglip™ (Reference) First|Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
542062|NCT00834587|B1|Baseline|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
542063|NCT00834587|P2|Participant Flow|Metaglip™ (Reference) First|Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
542064|NCT00834587|P1|Participant Flow|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
542065|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
542066|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
542067|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
542068|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
542069|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
542070|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
542071|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
542072|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
542073|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
542074|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
542075|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
542076|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
542077|NCT00834613|B3|Baseline|Total|Total of all reporting groups
542078|NCT00834613|B2|Baseline|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
542079|NCT00834613|B1|Baseline|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
542080|NCT00834613|P2|Participant Flow|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
542081|NCT00834613|P1|Participant Flow|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
542082|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
542083|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
542084|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
542085|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
542086|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
542087|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
542088|NCT00834626|B1|Baseline|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
542089|NCT00834626|P1|Participant Flow|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
542090|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
542091|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
542092|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
542093|NCT00834626|O1|Outcome|Percentage of Participants Not Requiring Insulin|Percentage of participants not requiring Insulin assessed at 1 year post-surgery
542094|NCT00834626|E1|Reported Event|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
542095|NCT00834639|B3|Baseline|Total|Total of all reporting groups
542096|NCT00834639|B2|Baseline|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
542097|NCT00834639|B1|Baseline|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
542098|NCT00834639|P2|Participant Flow|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
542099|NCT00834639|P1|Participant Flow|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
542919|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542100|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
542101|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
542102|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
542103|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
542104|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
542105|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
542106|NCT00834678|B1|Baseline|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.
bendamustine: 100 or 120 mg/m2 IV on days 1 and 2
erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle
Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
542107|NCT00834678|P1|Participant Flow|Bendamustine and Erlotinib|Patients in dose level I were administered Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and 100 mg PO of Erlotinib on days 5 – 21 of each 28 day cycle.
542108|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.
bendamustine: 100 or 120 mg/m2 IV on days 1 and 2
erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle
Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
542109|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.
bendamustine: 100 or 120 mg/m2 IV on days 1 and 2
erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle
Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
542110|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.
bendamustine: 100 or 120 mg/m2 IV on days 1 and 2
erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle
Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
542111|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.
bendamustine: 100 or 120 mg/m2 IV on days 1 and 2
erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle
Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
542112|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.
bendamustine: 100 or 120 mg/m2 IV on days 1 and 2
erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle
Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
542113|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.
bendamustine: 100 or 120 mg/m2 IV on days 1 and 2
erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle
Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
542114|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.
Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle."
542115|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.
Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle."
542116|NCT00834678|E1|Reported Event|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.
bendamustine: 100 or 120 mg/m2 IV on days 1 and 2
erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle
Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
542117|NCT00834717|B3|Baseline|Total|Total of all reporting groups
542118|NCT00834717|B2|Baseline|Kytril® (Reference) First|Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
542119|NCT00834717|B1|Baseline|Granisetron (Test) First|Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period
542120|NCT00834717|P2|Participant Flow|Kytril® (Reference) First|Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
542121|NCT00834717|P1|Participant Flow|Granisetron (Test) First|Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period
542122|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
542123|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
542124|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
542125|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
542126|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
542127|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
542128|NCT00834743|B3|Baseline|Total|Total of all reporting groups
542129|NCT00834743|B2|Baseline|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
542130|NCT00834743|B1|Baseline|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
542131|NCT00834743|P2|Participant Flow|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
542132|NCT00834743|P1|Participant Flow|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
542133|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
542134|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
542135|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
542136|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
542137|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
542138|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
542139|NCT00834756|B3|Baseline|Total|Total of all reporting groups
542140|NCT00834756|B2|Baseline|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
542141|NCT00834756|B1|Baseline|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
542142|NCT00834756|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
542143|NCT00834756|P1|Participant Flow|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
542144|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
542145|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
542146|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
542147|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
542148|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
542149|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
542150|NCT00834795|B3|Baseline|Total|Total of all reporting groups
542151|NCT00834795|B2|Baseline|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
542152|NCT00834795|B1|Baseline|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
542153|NCT00834795|P2|Participant Flow|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
542154|NCT00834795|P1|Participant Flow|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
542155|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
542156|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
542157|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
542158|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
542159|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
542160|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
542161|NCT00834808|B4|Baseline|Total|Total of all reporting groups
542162|NCT00834808|B3|Baseline|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542163|NCT00834808|B2|Baseline|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542164|NCT00834808|B1|Baseline|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542165|NCT00834808|P3|Participant Flow|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542166|NCT00834808|P2|Participant Flow|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542167|NCT00834808|P1|Participant Flow|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542168|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542169|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542170|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542171|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542172|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542173|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542174|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542175|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542176|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542177|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542178|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542179|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542180|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542181|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542182|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542183|NCT00834808|E3|Reported Event|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542184|NCT00834808|E2|Reported Event|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542185|NCT00834808|E1|Reported Event|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.
Randomization schedule based on a Latin Square design."
542186|NCT00834834|B3|Baseline|Total|Total of all reporting groups
542187|NCT00834834|B2|Baseline|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).
DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
542188|NCT00834834|B1|Baseline|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.
Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.
Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
542189|NCT00834834|P2|Participant Flow|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).
DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
542190|NCT00834834|P1|Participant Flow|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.
Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.
Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
542191|NCT00834834|O2|Outcome|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).
DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
542192|NCT00834834|O1|Outcome|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.
Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.
Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
542193|NCT00834834|O2|Outcome|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).
DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
542194|NCT00834834|O1|Outcome|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.
Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.
Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
542195|NCT00834834|E2|Reported Event|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).
DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
542196|NCT00834834|E1|Reported Event|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.
Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.
Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
542197|NCT00834873|B3|Baseline|Total|Total of all reporting groups
542198|NCT00834873|B2|Baseline|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
542199|NCT00834873|B1|Baseline|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period
542200|NCT00834873|P2|Participant Flow|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
542201|NCT00834873|P1|Participant Flow|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period
542202|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
542203|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
542204|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
542205|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
542206|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
542207|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
542208|NCT00834886|B5|Baseline|Total|Total of all reporting groups
542209|NCT00834886|B4|Baseline|Placebo Melatonin and Placebo Light|"Placebo melatonin + placebo light therapy
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo light"
542210|NCT00834886|B3|Baseline|Placebo Melatonin and Light Therapy|"Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542211|NCT00834886|B2|Baseline|Melatonin and Placebo Light|"Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light"
542212|NCT00834886|B1|Baseline|Melatonin and Light Therapy|"Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542213|NCT00834886|P4|Participant Flow|Placebo|"Placebo melatonin + placebo light therapy
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo light"
542214|NCT00834886|P3|Participant Flow|Bright Light|"Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542215|NCT00834886|P2|Participant Flow|Melatonin|"Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light"
542216|NCT00834886|P1|Participant Flow|Combination|"Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542217|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo light"
542218|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule
Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542219|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light
Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light"
542220|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin
Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542221|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo light"
542222|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule
Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542223|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light
Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light"
542224|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin
Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542225|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo light"
542226|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule
Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542227|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light
Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light"
542228|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin
Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542229|NCT00834886|E4|Reported Event|Placebo|"Placebo melatonin + placebo light therapy
Placebo melatonin: Capsule 3 mg, rice flour
placebo light therapy: Placebo light"
542230|NCT00834886|E3|Reported Event|Bright Light|"Placebo melatonin: Capsule 3 mg, rice flour
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542231|NCT00834886|E2|Reported Event|Melatonin|"Melatonin: Capsules, 3 mg, once every night
placebo light therapy: Placebo light"
542232|NCT00834886|E1|Reported Event|Combination|"Melatonin: Capsules, 3 mg, once every night
Light therapy: Light therapy 10.000 lux by Miljølys AS"
542233|NCT00834899|B3|Baseline|Total|Total of all reporting groups
542234|NCT00834899|B2|Baseline|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
542235|NCT00834899|B1|Baseline|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
542236|NCT00834899|P2|Participant Flow|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
542237|NCT00834899|P1|Participant Flow|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
542238|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
542239|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
542240|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
542241|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
542242|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
542243|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
542244|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
542245|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
542246|NCT00834899|E2|Reported Event|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
542247|NCT00834899|E1|Reported Event|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
542248|NCT00834912|B7|Baseline|Total|Total of all reporting groups
542249|NCT00834912|B6|Baseline|Trillium Fasting / Confab Fed / Confab Fasting|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
542250|NCT00834912|B5|Baseline|Trillium Fasting / Confab Fasting / Confab Fed|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
542251|NCT00834912|B4|Baseline|Confab Fed / Trillium Fasting / Confab Fasting|Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
542320|NCT00834990|B2|Baseline|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
542434|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542252|NCT00834912|B3|Baseline|Confab Fed / Confab Fasting / Trillium Fasting|Confab fed / Confab fasting / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
542253|NCT00834912|B2|Baseline|Confab Fasting / Trillium Fasting / Confab Fed|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
542254|NCT00834912|B1|Baseline|Confab Fasting / Confab Fed / Trillium Fasting|Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
542255|NCT00834912|P6|Participant Flow|Trillium Fasting / Confab Fed / Confab Fasting|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
542256|NCT00834912|P5|Participant Flow|Trillium Fasting / Confab Fasting / Confab Fed|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
542257|NCT00834912|P4|Participant Flow|Confab Fed / Trillium Fasting / Confab Fasting|Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
542258|NCT00834912|P3|Participant Flow|Confab Fed / Confab Fasting / Trillium Fasting|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
542259|NCT00834912|P2|Participant Flow|Confab Fasting / Trillium Fasting / Confab Fed|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
542260|NCT00834912|P1|Participant Flow|Confab Fasting / Confab Fed / Trillium Fasting|Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
542261|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
542262|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
542263|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
542264|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
542435|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542265|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
542266|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
542267|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
542268|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
542269|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
542270|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
542271|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
542272|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
542273|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
542274|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
542275|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
542321|NCT00834990|B1|Baseline|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
542436|NCT00828464|E1|Reported Event|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542276|NCT00834912|E3|Reported Event|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
542277|NCT00834912|E2|Reported Event|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
542278|NCT00834912|E1|Reported Event|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
542279|NCT00834964|B3|Baseline|Total|Total of all reporting groups
542280|NCT00834964|B2|Baseline|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
542281|NCT00834964|B1|Baseline|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
542282|NCT00834964|P2|Participant Flow|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
542283|NCT00834964|P1|Participant Flow|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
542284|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
542285|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
542286|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
542287|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
542288|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
542289|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
542290|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
542291|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
542292|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
542293|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
542294|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
542295|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
542296|NCT00834977|B3|Baseline|Total|Total of all reporting groups
542297|NCT00834977|B2|Baseline|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period
542298|NCT00834977|B1|Baseline|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period
542299|NCT00834977|P2|Participant Flow|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period
542300|NCT00834977|P1|Participant Flow|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period
542301|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542302|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
542303|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542304|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
542305|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542306|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
542307|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542308|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
542309|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542310|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
542311|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542312|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
542313|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542314|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
542315|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542316|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
542317|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542318|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
542322|NCT00834990|P2|Participant Flow|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
542323|NCT00834990|P1|Participant Flow|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
542324|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
542325|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
542326|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
542327|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
542328|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
542329|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
542330|NCT00835003|B3|Baseline|Total|Total of all reporting groups
542331|NCT00835003|B2|Baseline|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation
Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
542332|NCT00835003|B1|Baseline|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation
Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
542333|NCT00835003|P2|Participant Flow|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation
Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
542334|NCT00835003|P1|Participant Flow|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation
Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
542335|NCT00835003|O2|Outcome|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation
Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
542336|NCT00835003|O1|Outcome|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation
Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
542337|NCT00835003|E2|Reported Event|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation
Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
542338|NCT00835003|E1|Reported Event|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation
Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
542339|NCT00835042|B3|Baseline|Total|Total of all reporting groups
542340|NCT00835042|B2|Baseline|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
542341|NCT00835042|B1|Baseline|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
542342|NCT00835042|P2|Participant Flow|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
542343|NCT00835042|P1|Participant Flow|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
542344|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
542345|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
542346|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
542347|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
542348|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
542349|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
542350|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
542351|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
542352|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
542353|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
542354|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
542355|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
542356|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
542357|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
542358|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
542359|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
542360|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
542361|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
542362|NCT00835068|B3|Baseline|Total|Total of all reporting groups
542363|NCT00835068|B2|Baseline|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
542920|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
542364|NCT00835068|B1|Baseline|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542365|NCT00835068|P2|Participant Flow|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
542366|NCT00835068|P1|Participant Flow|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542367|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542368|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542369|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542370|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542371|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
542372|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542373|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542374|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542375|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
542376|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542377|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
542378|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542379|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
542380|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542381|NCT00835068|E2|Reported Event|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
542382|NCT00835068|E1|Reported Event|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
542383|NCT00835081|B3|Baseline|Total|Total of all reporting groups
542384|NCT00835081|B2|Baseline|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
542385|NCT00835081|B1|Baseline|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
542386|NCT00835081|P2|Participant Flow|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
542387|NCT00835081|P1|Participant Flow|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
542388|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
542389|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
542390|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
542391|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
542392|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
542393|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
542433|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542921|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542394|NCT00835120|B1|Baseline|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
542395|NCT00835120|P1|Participant Flow|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
542396|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
542397|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
542398|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
542399|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
542400|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
542401|NCT00835120|E1|Reported Event|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
542402|NCT00835146|B3|Baseline|Total|Total of all reporting groups
542403|NCT00835146|B2|Baseline|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
542404|NCT00835146|B1|Baseline|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
542405|NCT00835146|P2|Participant Flow|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
542406|NCT00835146|P1|Participant Flow|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
542407|NCT00835146|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
542408|NCT00835146|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
542409|NCT00835146|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
542410|NCT00835146|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
542411|NCT00828412|B3|Baseline|Total|Total of all reporting groups
542412|NCT00828412|B2|Baseline|Desonide Cream 0.05%|Desonide Cream 0.05%
542413|NCT00828412|B1|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
542414|NCT00828412|P2|Participant Flow|Desonide Cream 0.05%|Desonide Cream 0.05% topically twice daily
542415|NCT00828412|P1|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion topically twice daily
542416|NCT00828412|O2|Outcome|Desonide Cream 0.05%|Week 6 Desonide Cream 0.05%
542417|NCT00828412|O1|Outcome|EpiCeram Skin Barrier Emulsion|Week 6 EpiCeram Skin Barrier Emulsion
542418|NCT00828412|E2|Reported Event|Desonide Cream 0.05%|Desonide Cream 0.05%
542419|NCT00828412|E1|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
542420|NCT00828464|B1|Baseline|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542421|NCT00828464|P1|Participant Flow|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542422|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542423|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542424|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542425|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542426|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542427|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542428|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542429|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542430|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542431|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
542432|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
552231|NCT00852917|E3|Reported Event|3: Tramadol Once A Day 300mg|
542437|NCT00828516|B1|Baseline|Clinical Phase|Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment
542438|NCT00828516|P1|Participant Flow|Clinical Phase|Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment. Acupuncture and moxibustion, individualised according to participant priorities, delivered once weekly for 7 treatments (Series 1) followed by a further 6 treatments (Series 2) if participant wishes to continue treatment.
542439|NCT00828516|O1|Outcome|Usual Care Plus Traditional Acupuncture|All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
542440|NCT00828516|O1|Outcome|Usual Care Plus Traditional Acupuncture|All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
542441|NCT00828516|E1|Reported Event|Usual Care Plus Traditional Acupuncture|
542442|NCT00828542|B3|Baseline|Total|Total of all reporting groups
542443|NCT00828542|B2|Baseline|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of DMPA (Contracept®, EMS Sigma Pharma, Hortolândia, Brazil)
542444|NCT00828542|B1|Baseline|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24–48 h after delivery
542445|NCT00828542|P2|Participant Flow|Depot Medroxyprogesterone Acetate|Women randomized to depot medroxyprogesterone acetate group had at the 6th week postpartum, 150 mg of depot medroxyprogesterone acetate intramuscular (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil). A new injection was applied every 90 days if the patient wished to keep using the method.
542446|NCT00828542|P1|Participant Flow|Etonogestrel Implant|Immediately after giving birth, women randomized to etonogestrel implant group had an Etonogestrel releasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery. It is a long-acting reversible contraceptive method, compounded by 68mg of etonogestrel, 3years of duration.
542447|NCT00828542|O2|Outcome|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of depot medroxyprogesterone (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil)
542448|NCT00828542|O1|Outcome|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24–48 h after delivery
542449|NCT00828542|E2|Reported Event|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of depot medroxyprogesterone (Contracept®, EMS Sigma Pharma, Hortolândia, Brazil)
542450|NCT00828542|E1|Reported Event|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24–48 h after delivery
542451|NCT00828568|B4|Baseline|Total|Total of all reporting groups
542452|NCT00828568|B3|Baseline|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
542453|NCT00828568|B2|Baseline|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
542454|NCT00828568|B1|Baseline|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
542455|NCT00828568|P3|Participant Flow|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
542456|NCT00828568|P2|Participant Flow|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
542457|NCT00828568|P1|Participant Flow|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
542458|NCT00828568|O3|Outcome|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
542459|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
542460|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
542461|NCT00828568|O3|Outcome|Vehicle|Patients receiving imiquimod vehicle for 16 weeks
542462|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
542463|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
542464|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
542465|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
542466|NCT00828568|E3|Reported Event|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
542467|NCT00828568|E2|Reported Event|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
542468|NCT00828568|E1|Reported Event|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
542469|NCT00828711|B4|Baseline|Total|Total of all reporting groups
542470|NCT00828711|B3|Baseline|MVI 200|"MVI 200 mcg vaginal insert
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542471|NCT00828711|B2|Baseline|MVI 150|"MVI 150 mcg vaginal insert
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542472|NCT00828711|B1|Baseline|MVI 100|"MVI 100 mcg vaginal insert
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542473|NCT00828711|P3|Participant Flow|MVI 200|"MVI 200 mcg vaginal insert
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542922|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
542474|NCT00828711|P2|Participant Flow|MVI 150|"MVI 150 mcg vaginal insert
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542475|NCT00828711|P1|Participant Flow|MVI 100|"MVI 100 mcg vaginal insert
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542476|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542477|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542478|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542479|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542480|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542481|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542482|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542483|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542484|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542485|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542486|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542487|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542488|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542489|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542490|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542491|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542492|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542493|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542494|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542495|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542496|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542497|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542498|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542499|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542500|NCT00828711|E3|Reported Event|MVI 200|"MVI 200 mcg vaginal insert
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542501|NCT00828711|E2|Reported Event|MVI 150|"MVI 150 mcg vaginal insert
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542502|NCT00828711|E1|Reported Event|MVI 100|"MVI 100 mcg vaginal insert
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
542503|NCT00828750|B1|Baseline|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
542504|NCT00828750|P1|Participant Flow|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count (PC) at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
542505|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
542506|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
542507|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
542508|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
542923|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542933|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542509|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
542510|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
542511|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
542512|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
542513|NCT00828750|E1|Reported Event|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
542514|NCT00828841|B4|Baseline|Total|Total of all reporting groups
542515|NCT00828841|B3|Baseline|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.
Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542516|NCT00828841|B2|Baseline|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.
Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542517|NCT00828841|B1|Baseline|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.
Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542518|NCT00828841|P3|Participant Flow|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.
Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542519|NCT00828841|P2|Participant Flow|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.
Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542552|NCT00828984|P1|Participant Flow|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
552232|NCT00852917|E2|Reported Event|2: Tramadol Once A Day 200mg|
542520|NCT00828841|P1|Participant Flow|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.
Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542521|NCT00828841|O2|Outcome|Non-squamous Cell Histology|Subjects who were identified as having non-squamous cell histology, prior to randomization to a treatment arm.
542522|NCT00828841|O1|Outcome|Squamous Cell Histology|Subjects who were identified as having squamous cell histology, prior to randomization to a treatment arm.
542523|NCT00828841|O3|Outcome|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.
Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542524|NCT00828841|O2|Outcome|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.
Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542525|NCT00828841|O1|Outcome|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.
Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542526|NCT00828841|O3|Outcome|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.
Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542527|NCT00828841|O2|Outcome|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.
Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542528|NCT00828841|O1|Outcome|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.
Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542553|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542554|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
543091|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
542529|NCT00828841|E3|Reported Event|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.
Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542530|NCT00828841|E2|Reported Event|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.
Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542531|NCT00828841|E1|Reported Event|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.
Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days
Carboplatin : Carboplatin AUC 6 Day 1 every 21 days
Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
542532|NCT00828945|B1|Baseline|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542533|NCT00828945|P1|Participant Flow|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542534|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542535|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542536|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542537|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542538|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542539|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542540|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542541|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542542|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542543|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542544|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542545|NCT00828945|E1|Reported Event|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
542546|NCT00828984|B4|Baseline|Total|Total of all reporting groups
542547|NCT00828984|B3|Baseline|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542548|NCT00828984|B2|Baseline|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542549|NCT00828984|B1|Baseline|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542550|NCT00828984|P3|Participant Flow|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542551|NCT00828984|P2|Participant Flow|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542924|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
542555|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542556|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542557|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542558|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542559|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542560|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542561|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542562|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542563|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542564|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542565|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542566|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542567|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542568|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542569|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542570|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542571|NCT00828984|E3|Reported Event|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542572|NCT00828984|E2|Reported Event|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
8g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542573|NCT00828984|E1|Reported Event|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
17g day/macrogol 3350-based oral osmotic laxative: Given PO
Laboratory Biomarker Analysis: Correlative studies"
542574|NCT00829010|B6|Baseline|Total|Total of all reporting groups
542575|NCT00829010|B5|Baseline|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542768|NCT00835159|P1|Participant Flow|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
542769|NCT00835159|O2|Outcome|Placebo Patch|Eligible patients received a placebo patch
542576|NCT00829010|B4|Baseline|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542577|NCT00829010|B3|Baseline|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542578|NCT00829010|B2|Baseline|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542579|NCT00829010|B1|Baseline|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542580|NCT00829010|P5|Participant Flow|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542581|NCT00829010|P4|Participant Flow|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542582|NCT00829010|P3|Participant Flow|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542770|NCT00835159|O1|Outcome|Rivastigmine Patch|Eligible patients received a rivastigmine 5-cm2 transdermal patch
542925|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542926|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
542927|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542583|NCT00829010|P2|Participant Flow|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542584|NCT00829010|P1|Participant Flow|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542585|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542586|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542587|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542588|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542589|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542771|NCT00835159|E2|Reported Event|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
552233|NCT00852917|E1|Reported Event|1: Tramadol Once A Day 100mg|
542590|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542591|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542592|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542593|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542594|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542595|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542596|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542772|NCT00835159|E1|Reported Event|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
542773|NCT00835172|B3|Baseline|Total|Total of all reporting groups
542597|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542598|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542599|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542600|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542601|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542602|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542603|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542774|NCT00835172|B2|Baseline|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
542775|NCT00835172|B1|Baseline|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
542776|NCT00835172|P2|Participant Flow|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
542604|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542605|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542606|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542607|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542608|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542609|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542610|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542777|NCT00835172|P1|Participant Flow|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
542778|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
542779|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
542780|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
542611|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542612|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542613|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542614|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542615|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542616|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542617|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542781|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
542782|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
542783|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
542928|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
542929|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542618|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542619|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542620|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542621|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542622|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542623|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542624|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542850|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
542851|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
542852|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
543881|NCT00832455|B1|Baseline|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
542625|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542626|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542627|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542628|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542629|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542630|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542631|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542853|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
542854|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
542855|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
542856|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
542632|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542633|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542634|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542635|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542636|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542637|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542638|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542857|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
542858|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
542859|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
552234|NCT00852930|B4|Baseline|Total|Total of all reporting groups
542639|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542640|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542641|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542642|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542643|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542644|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542645|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542860|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
542861|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
542862|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
543882|NCT00832455|P1|Participant Flow|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
542646|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542647|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542648|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542649|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542650|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542651|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542652|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542863|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
542864|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
542865|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
542866|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
542653|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542654|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542655|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542656|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542657|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542658|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542659|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542867|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
542868|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
542869|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
543883|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|
542660|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542661|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542662|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542663|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542664|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542665|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542666|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542870|NCT00835237|E2|Reported Event|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
542871|NCT00835237|E1|Reported Event|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
542872|NCT00835263|B3|Baseline|Total|Total of all reporting groups
542873|NCT00835263|B2|Baseline|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
542667|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542668|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542669|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542670|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542671|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542672|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542673|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542874|NCT00835263|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
542875|NCT00835263|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
542876|NCT00835263|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
542674|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542675|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542676|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542677|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542678|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542679|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542680|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542877|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
542878|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
542879|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
542880|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
542881|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
542681|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542682|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542683|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542684|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542685|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542686|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542687|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542882|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
542883|NCT00835276|B3|Baseline|Total|Total of all reporting groups
542884|NCT00835276|B2|Baseline|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
542930|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
543884|NCT00832455|O2|Outcome|Montelukast ITT at Week 8|
542688|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542689|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542690|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542691|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542692|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542693|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542694|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542885|NCT00835276|B1|Baseline|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
542886|NCT00835276|P2|Participant Flow|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
542931|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542695|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542696|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542697|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542698|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542699|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542700|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542701|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542887|NCT00835276|P1|Participant Flow|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
542888|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
542889|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
542890|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
542702|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542703|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542704|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542705|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542706|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542707|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542708|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542891|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
542892|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
542893|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
542894|NCT00835341|B3|Baseline|Total|Total of all reporting groups
543885|NCT00832455|O1|Outcome|Montelukast ITT at Week 4|
542709|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542710|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542711|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542712|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542713|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542714|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542715|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542895|NCT00835341|B2|Baseline|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
542896|NCT00835341|B1|Baseline|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
542897|NCT00835341|P2|Participant Flow|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
543886|NCT00832455|O4|Outcome|Montelukast ITT at Week 12|
542716|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542717|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542718|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542719|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542720|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542721|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542722|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542898|NCT00835341|P1|Participant Flow|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
542899|NCT00835341|O2|Outcome|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
542900|NCT00835341|O1|Outcome|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
542901|NCT00835341|E2|Reported Event|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
542723|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542724|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542725|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542726|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542727|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542728|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542729|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542902|NCT00835341|E1|Reported Event|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
542903|NCT00835354|B3|Baseline|Total|Total of all reporting groups
542904|NCT00835354|B2|Baseline|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
543887|NCT00832455|O3|Outcome|Montelukast ITT at Week 8|
542730|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542731|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542732|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542733|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542734|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542735|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542736|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542905|NCT00835354|B1|Baseline|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
542906|NCT00835354|P2|Participant Flow|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
542932|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
542737|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542738|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542739|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542740|NCT00829010|E5|Reported Event|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542741|NCT00829010|E4|Reported Event|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542742|NCT00829010|E3|Reported Event|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542743|NCT00829010|E2|Reported Event|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542907|NCT00835354|P1|Participant Flow|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
542908|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
542909|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
542744|NCT00829010|E1|Reported Event|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
542745|NCT00829036|B1|Baseline|Baseline Wayfinding Performance|An Orientation and Mobility specialist teaches subjects (1) how to find each of 4 specific locations in an open space from a random starting location, and (2) how to navigate hallways from a known starting location to find each of 8 specific locations in the hallways of the Atlanta VA Medical Center. Subjects are then (1) brought to a random start point in the open space and asked to walk to the same 4 specific locations they were taught to find and (2) brought to a known starting point in the hallways of the VA Medical Center and asked to walk to the same 8 specific locations they were taught to find.
542746|NCT00829036|P1|Participant Flow|Prototype vs. Baseline|"Prototype:
Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.
Baseline:
An Orientation and Mobility (O&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure."
542747|NCT00829036|O1|Outcome|Prototype vs. Baseline|"Prototype:
Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.
Baseline:
An Orientation and Mobility (O&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure."
542748|NCT00829036|E1|Reported Event|Wayfinding: Prototype vs. Baseline|"Prototype:
Subjects are trained to use the prototype to walk to selected destinations (1) in open spaces and (2) through hallways. Then, over 12 trials, subjects are asked to use the prototype to walk to a different unknown location in each trial. Half the locations are in open spaces and half in hallways. Performance time is measured.
Baseline:
An Orientation and Mobility (O&M) specialist first teaches the subjects how to find (walk to) 12 specific locations, 6 in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations. Performance time is measured."
542749|NCT00829049|B3|Baseline|Total|Total of all reporting groups
542750|NCT00829049|B2|Baseline|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
542751|NCT00829049|B1|Baseline|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
542752|NCT00829049|P2|Participant Flow|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
542753|NCT00829049|P1|Participant Flow|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
542754|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
542755|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
542756|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
542757|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
542758|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
542759|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
542760|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
542761|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
542762|NCT00829049|E2|Reported Event|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
542763|NCT00829049|E1|Reported Event|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
542764|NCT00835159|B3|Baseline|Total|Total of all reporting groups
542765|NCT00835159|B2|Baseline|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
542766|NCT00835159|B1|Baseline|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
542767|NCT00835159|P2|Participant Flow|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
542910|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
542911|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
542784|NCT00835185|B1|Baseline|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542785|NCT00835185|P1|Participant Flow|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 milligrams (mg) IMC-11F8 intravenous (IV) infusion over 50 minutes
85 milligrams per meter square (mg/m²) oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent or until other criteria for treatment discontinuation were met."
542786|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542787|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542788|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542789|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542790|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542791|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542792|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542793|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes;
85 mg/m² oxaliplatin IV infusion over 2 hours;
400 mg/m² folinic acid;
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
542912|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
542913|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
542914|NCT00835367|B3|Baseline|Total|Total of all reporting groups
542915|NCT00835367|B2|Baseline|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test)dosed in second period
542794|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes;
85 mg/m² oxaliplatin IV infusion over 2 hours;
400 mg/m² folinic acid;
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
542795|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes;
85 mg/m² oxaliplatin IV infusion over 2 hours;
400 mg/m² folinic acid;
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
542796|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes;
85 mg/m² oxaliplatin IV infusion over 2 hours;
400 mg/m² folinic acid;
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
542797|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes;
85 mg/m² oxaliplatin IV infusion over 2 hours;
400 mg/m² folinic acid;
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
542798|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542799|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542800|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542801|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542802|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542803|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes
85 mg/m² oxaliplatin IV infusion over 2 hours
400 mg/m² folinic acid
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542916|NCT00835367|B1|Baseline|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed in second period
542917|NCT00835367|P2|Participant Flow|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test)dosed in second period
542918|NCT00835367|P1|Participant Flow|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed in second period
542804|NCT00835185|E1|Reported Event|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
800 mg IMC-11F8 IV infusion over 50 minutes;
85 mg/m² oxaliplatin IV infusion over 2 hours;
400 mg/m² folinic acid;
400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
542805|NCT00835198|B3|Baseline|Total|Total of all reporting groups
542806|NCT00835198|B2|Baseline|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
542807|NCT00835198|B1|Baseline|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
542808|NCT00835198|P2|Participant Flow|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
542809|NCT00835198|P1|Participant Flow|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
542810|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
542811|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
542812|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
542813|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
542814|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
542815|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
542816|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
542817|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
542818|NCT00835198|E2|Reported Event|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
542819|NCT00835198|E1|Reported Event|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
542820|NCT00835211|B3|Baseline|Total|Total of all reporting groups
542821|NCT00835211|B2|Baseline|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
542822|NCT00835211|B1|Baseline|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
542823|NCT00835211|P2|Participant Flow|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
542824|NCT00835211|P1|Participant Flow|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
542825|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
542826|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
542827|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
542828|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
542829|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
542830|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
542831|NCT00835224|B1|Baseline|All Participants|All participants were studied on three laboratory visits and underwent seated blood pressure assessment before and after administration of Midodrine, L-NAME or placebo, which were given in random order.
542832|NCT00835224|P1|Participant Flow|All Participants|All Participants visited the laboratory on 3 occasions for a 4-5 hour observation of blood pressure following administration of a non-selective inhibitor of nitric oxide synthase (L-NAME) an alpha-agonist (midodrine) or placebo. The interventions were administered in random order on separate laboratory visits.
542833|NCT00835224|O6|Outcome|Arm 3B|Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
542834|NCT00835224|O5|Outcome|Arm 3A|Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
542835|NCT00835224|O4|Outcome|Arm 2B|Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
542836|NCT00835224|O3|Outcome|Arm 2A|Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
542837|NCT00835224|O2|Outcome|Arm 1B|Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
542838|NCT00835224|O1|Outcome|Arm 1A|Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
542839|NCT00835224|E6|Reported Event|Arm 3B|Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
542840|NCT00835224|E5|Reported Event|Arm 3A|Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
542841|NCT00835224|E4|Reported Event|Arm 2B|Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
542842|NCT00835224|E3|Reported Event|Arm 2A|Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
542843|NCT00835224|E2|Reported Event|Arm 1B|Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
542844|NCT00835224|E1|Reported Event|Arm 1A|Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
542845|NCT00835237|B3|Baseline|Total|Total of all reporting groups
542846|NCT00835237|B2|Baseline|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
542847|NCT00835237|B1|Baseline|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
542848|NCT00835237|P2|Participant Flow|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
542849|NCT00835237|P1|Participant Flow|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
542934|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
542935|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
542936|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
542937|NCT00835380|B1|Baseline|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
542938|NCT00835380|P1|Participant Flow|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
542939|NCT00835380|O1|Outcome|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
542940|NCT00835380|O1|Outcome|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
542941|NCT00835380|E1|Reported Event|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
542942|NCT00835406|B3|Baseline|Total|Total of all reporting groups
542943|NCT00835406|B2|Baseline|Fosamax® First|70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
542944|NCT00835406|B1|Baseline|Alendronate Sodium First|70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
542945|NCT00835406|P2|Participant Flow|Fosamax® First|70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
542946|NCT00835406|P1|Participant Flow|Alendronate Sodium First|70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
542947|NCT00835406|O2|Outcome|Fosamax®|70 mg Fosamax® Tablets reference product dosed in either period
542948|NCT00835406|O1|Outcome|Alendronate Sodium|70 mg Alendronate Sodium Tablets test product dosed in either period
542949|NCT00835406|O2|Outcome|Fosamax®|70 mg Fosamax® Tablets reference product dosed in either period
542950|NCT00835406|O1|Outcome|Alendronate Sodium|70 mg Alendronate Sodium Tablets test product dosed in either period
542951|NCT00835484|B3|Baseline|Total|Total of all reporting groups
542952|NCT00835484|B2|Baseline|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
542953|NCT00835484|B1|Baseline|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
542954|NCT00835484|P2|Participant Flow|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
542955|NCT00835484|P1|Participant Flow|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
542956|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
542957|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
542958|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
542959|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
542960|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
542961|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
542962|NCT00835861|B3|Baseline|Total|Total of all reporting groups
542963|NCT00835861|B2|Baseline|Insulin|Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
542964|NCT00835861|B1|Baseline|Metformin|Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone.
542965|NCT00835861|P2|Participant Flow|Insulin|Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and neutral protamine Hagedorn (NPH) insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
542966|NCT00835861|P1|Participant Flow|Metformin|Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone
542967|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
542968|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
542969|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
542970|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
542971|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
542972|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
542973|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
542974|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
542975|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
542976|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
542977|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
542978|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
542979|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
542980|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
542981|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
543092|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
543093|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
542982|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
542983|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
542984|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
542985|NCT00835861|E2|Reported Event|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
542986|NCT00835861|E1|Reported Event|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
542987|NCT00835900|B3|Baseline|Total|Total of all reporting groups
542988|NCT00835900|B2|Baseline|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.
Both groups received brief cognitive-behavioral counseling."
542989|NCT00835900|B1|Baseline|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
542990|NCT00835900|P2|Participant Flow|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.
Both groups received brief cognitive-behavioral counseling."
542991|NCT00835900|P1|Participant Flow|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
542992|NCT00835900|O2|Outcome|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.
Both groups received brief cognitive-behavioral counseling."
542993|NCT00835900|O1|Outcome|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
542994|NCT00835900|O2|Outcome|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.
Both groups received brief cognitive-behavioral counseling."
542995|NCT00835900|O1|Outcome|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
542996|NCT00835900|E2|Reported Event|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.
Both groups received brief cognitive-behavioral counseling."
542997|NCT00835900|E1|Reported Event|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
542998|NCT00835926|B3|Baseline|Total|Total of all reporting groups
542999|NCT00835926|B2|Baseline|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
543000|NCT00835926|B1|Baseline|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
543001|NCT00835926|P2|Participant Flow|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
543002|NCT00835926|P1|Participant Flow|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
543003|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
543004|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
543005|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
543006|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
543007|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
543008|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
543009|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
543010|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
543011|NCT00835926|E2|Reported Event|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
543012|NCT00835926|E1|Reported Event|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
543013|NCT00835978|B5|Baseline|Total|Total of all reporting groups
543014|NCT00835978|B4|Baseline|Discontinued Prior to Randomization|Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
543015|NCT00835978|B3|Baseline|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543016|NCT00835978|B2|Baseline|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543017|NCT00835978|B1|Baseline|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543018|NCT00835978|P4|Participant Flow|Discontinued Prior to Randomization|Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
543019|NCT00835978|P3|Participant Flow|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543020|NCT00835978|P2|Participant Flow|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543021|NCT00835978|P1|Participant Flow|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543022|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543023|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543024|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543025|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543026|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543027|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543028|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543029|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo[blinded therapy] 5 mg BID).
543030|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543031|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543032|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543094|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
543095|NCT00836004|B3|Baseline|Total|Total of all reporting groups
543033|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543034|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543035|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543036|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543037|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543038|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543039|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543040|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543041|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543042|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543043|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543044|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543045|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543046|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo[blinded therapy] 5 mg BID).
543047|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543048|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543096|NCT00836004|B2|Baseline|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
543049|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543050|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo[blinded therapy] 5 mg BID).
543051|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543052|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543053|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543054|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543055|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543056|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543057|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543058|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543059|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543060|NCT00835978|O3|Outcome|Non-randomized Arm (SA Population)|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543061|NCT00835978|O2|Outcome|Placebo Titration Arm (FA Population)|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543062|NCT00835978|O1|Outcome|Active Titration Arm (FA Population)|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543063|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543172|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
543064|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543065|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543066|NCT00835978|O4|Outcome|All Participants|All enrolled participants (randomized and non-randomized)
543067|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543068|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543069|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543070|NCT00835978|O4|Outcome|All Participants|All enrolled participants (randomized and non-randomized)
543071|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543072|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543073|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543074|NCT00835978|E4|Reported Event|Discontinued Prior to Randomization|Participants who were discontinued prior to randomization to either treatment or non-randomization arms.
543075|NCT00835978|E3|Reported Event|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
543076|NCT00835978|E2|Reported Event|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
543077|NCT00835978|E1|Reported Event|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
543078|NCT00835991|B3|Baseline|Total|Total of all reporting groups
543079|NCT00835991|B2|Baseline|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
543080|NCT00835991|B1|Baseline|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
543081|NCT00835991|P2|Participant Flow|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
543082|NCT00835991|P1|Participant Flow|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
543083|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
543084|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
543085|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
543086|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
543087|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
543088|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
543089|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
543090|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
543097|NCT00836004|B1|Baseline|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
543098|NCT00836004|P2|Participant Flow|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
543099|NCT00836004|P1|Participant Flow|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
543100|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
543101|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
543102|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
543103|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
543104|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
543105|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
543106|NCT00836017|B1|Baseline|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
543107|NCT00836017|P1|Participant Flow|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
543108|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
543109|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
543110|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
543111|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
543112|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
543113|NCT00836017|E1|Reported Event|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
543114|NCT00836056|B3|Baseline|Total|Total of all reporting groups
543115|NCT00836056|B2|Baseline|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
543116|NCT00836056|B1|Baseline|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
543117|NCT00836056|P2|Participant Flow|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
543118|NCT00836056|P1|Participant Flow|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
543119|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
543120|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
543121|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
543122|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
543123|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
543124|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
543125|NCT00836095|B3|Baseline|Total|Total of all reporting groups
543126|NCT00836095|B2|Baseline|Proseal LMA|"The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.
Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway"
543127|NCT00836095|B1|Baseline|Supreme LMA|"The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.
Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant."
543128|NCT00836095|P2|Participant Flow|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway.
The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
543129|NCT00836095|P1|Participant Flow|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.
The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
543130|NCT00836095|O2|Outcome|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway
The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
543131|NCT00836095|O1|Outcome|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant
The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
543132|NCT00836095|O2|Outcome|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway
The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
543173|NCT00836355|O4|Outcome|Control|
543888|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|
543133|NCT00836095|O1|Outcome|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant
The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
543134|NCT00836095|E2|Reported Event|Proseal LMA|"Proseal is a multiple use, variant of the laryngeal mask airway.
The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.
Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway"
543135|NCT00836095|E1|Reported Event|Supreme LMA|"Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.
The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.
Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant"
543136|NCT00836277|B1|Baseline|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
543137|NCT00836277|P1|Participant Flow|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
543138|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
543139|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
543140|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
543141|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
543142|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
543143|NCT00836277|E1|Reported Event|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
543144|NCT00836342|B4|Baseline|Total|Total of all reporting groups
543145|NCT00836342|B3|Baseline|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
543146|NCT00836342|B2|Baseline|Previous History of BCC|Participants had previous history of basal cell carcinoma
543147|NCT00836342|B1|Baseline|Previous History of SCC|Participants had previous history of squamous cell carcinoma
543148|NCT00836342|P3|Participant Flow|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
543149|NCT00836342|P2|Participant Flow|Previous History of BCC|Participants had previous history of basal cell carcinoma
543150|NCT00836342|P1|Participant Flow|Previous History of SCC|Participants had previous history of squamous cell carcinoma
543151|NCT00836342|O2|Outcome|Control Group|Participants had no history of previous squamous cell carcinoma or basal cell carcinoma
543152|NCT00836342|O1|Outcome|Previous History of BCC|Participants had previous history of basal cell carcinoma
543153|NCT00836342|O2|Outcome|Previous History of BCC|Participants had previous history of basal cell carcinoma
543154|NCT00836342|O1|Outcome|Previous History of SCC|Participants had previous history of squamous cell carcinoma
543155|NCT00836342|O2|Outcome|Control Group|Participants had no previous history or squamous cell carcinoma or basal cell carcinoma
543156|NCT00836342|O1|Outcome|Previous History of SCC|Participants had previous history of squamous cell carcinoma
543157|NCT00836342|E3|Reported Event|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
543158|NCT00836342|E2|Reported Event|Previous History of BCC|Participants had previous history of basal cell carcinoma
543159|NCT00836342|E1|Reported Event|Previous History of SCC|Participants had previous history of squamous cell carcinoma
543160|NCT00836355|B5|Baseline|Total|Total of all reporting groups
543161|NCT00836355|B4|Baseline|Control|
543162|NCT00836355|B3|Baseline|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
Minocycline: 200 mg orally once daily for 5 days"
543163|NCT00836355|B2|Baseline|Minocycline|"Minocycline 200 mg orally once daily for 5 days
Minocycline: 200 mg orally once daily for 5 days"
543164|NCT00836355|B1|Baseline|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
543165|NCT00836355|P4|Participant Flow|Control|
543166|NCT00836355|P3|Participant Flow|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
Minocycline: 200 mg orally once daily for 5 days"
543167|NCT00836355|P2|Participant Flow|Minocycline|"Minocycline 200 mg orally once daily for 5 days
Minocycline: 200 mg orally once daily for 5 days"
543168|NCT00836355|P1|Participant Flow|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
543169|NCT00836355|O4|Outcome|Control|
543170|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
Minocycline: 200 mg orally once daily for 5 days"
543171|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days
Minocycline: 200 mg orally once daily for 5 days"
543889|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|
543174|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
Minocycline: 200 mg orally once daily for 5 days"
543175|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days
Minocycline: 200 mg orally once daily for 5 days"
543176|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
543177|NCT00836355|O4|Outcome|Control|
543178|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
Minocycline: 200 mg orally once daily for 5 days"
543179|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days
Minocycline: 200 mg orally once daily for 5 days"
543180|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
543181|NCT00836355|E4|Reported Event|Control|
543182|NCT00836355|E3|Reported Event|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
Minocycline: 200 mg orally once daily for 5 days"
543183|NCT00836355|E2|Reported Event|Minocycline|"Minocycline 200 mg orally once daily for 5 days
Minocycline: 200 mg orally once daily for 5 days"
543184|NCT00836355|E1|Reported Event|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
543185|NCT00836407|B3|Baseline|Total|Total of all reporting groups
543186|NCT00836407|B2|Baseline|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
543187|NCT00836407|B1|Baseline|Arm 1: Ipilimumab Alone|Ipilimumab alone
543188|NCT00836407|P2|Participant Flow|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
543189|NCT00836407|P1|Participant Flow|Arm 1: Ipilimumab Alone|Ipilimumab alone
543190|NCT00836407|O2|Outcome|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
543191|NCT00836407|O1|Outcome|Arm 1: Ipilimumab Alone|Ipilimumab alone
543192|NCT00836407|O2|Outcome|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
543193|NCT00836407|O1|Outcome|Arm 1: Ipilimumab Alone|Ipilimumab alone
543194|NCT00836407|E2|Reported Event|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
543195|NCT00836407|E1|Reported Event|Arm 1: Ipilimumab Alone|Ipilimumab alone
543196|NCT00836433|B3|Baseline|Total|Total of all reporting groups
543197|NCT00836433|B2|Baseline|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication
CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving
FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
543198|NCT00836433|B1|Baseline|FALLS Only|"Traditional falls educational intervention
FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
543199|NCT00836433|P2|Participant Flow|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication
CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving
FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
543200|NCT00836433|P1|Participant Flow|FALLS Only|"Traditional falls educational intervention
FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
543201|NCT00836433|O2|Outcome|CONNECT and FALLS|"CONNECT intervention on relationship-building and communication. Includes 2 in-class session, group mapping, individual relationship mapping, coaching sessions.
CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving
FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
543202|NCT00836433|O1|Outcome|FALLS Only|"Traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.
FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
543203|NCT00836433|O2|Outcome|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication
CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving
FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
543204|NCT00836433|O1|Outcome|FALLS|"Traditional falls educational intervention
FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
543205|NCT00836433|E2|Reported Event|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication
CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving
FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
543206|NCT00836433|E1|Reported Event|FALLS Only|"Traditional falls educational intervention
FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
543207|NCT00836472|B3|Baseline|Total|Total of all reporting groups
543208|NCT00836472|B2|Baseline|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
543209|NCT00836472|B1|Baseline|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
543210|NCT00836472|P2|Participant Flow|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
543211|NCT00836472|P1|Participant Flow|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
543212|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
543213|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
543214|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
543215|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
543216|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
543217|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
543218|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
543219|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
543220|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
543221|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
543222|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
543223|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
543224|NCT00836498|B3|Baseline|Total|Total of all reporting groups
543225|NCT00836498|B2|Baseline|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543226|NCT00836498|B1|Baseline|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543227|NCT00836498|P2|Participant Flow|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543228|NCT00836498|P1|Participant Flow|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543229|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543230|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543231|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543232|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543233|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543234|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543235|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543236|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543237|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543238|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543239|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543240|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543241|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543242|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543243|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543244|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543245|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543246|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543280|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543247|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543248|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543249|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543250|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543251|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543252|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543253|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543254|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543255|NCT00836498|E2|Reported Event|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543256|NCT00836498|E1|Reported Event|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
543257|NCT00836641|B3|Baseline|Total|Total of all reporting groups
543258|NCT00836641|B2|Baseline|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
543259|NCT00836641|B1|Baseline|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
543260|NCT00836641|P2|Participant Flow|Group B: Sequential Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
543261|NCT00836641|P1|Participant Flow|Group A: Sequential Pneumococcal Immunzation (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
543262|NCT00836641|O2|Outcome|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
543263|NCT00836641|O1|Outcome|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
543264|NCT00836641|O2|Outcome|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
543265|NCT00836641|O1|Outcome|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
543266|NCT00836641|E1|Reported Event|Overall Study Population|the whole study population was observed for adverse events.
543267|NCT00836693|B3|Baseline|Total|Total of all reporting groups
543268|NCT00836693|B2|Baseline|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543269|NCT00836693|B1|Baseline|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543270|NCT00836693|P2|Participant Flow|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543271|NCT00836693|P1|Participant Flow|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543272|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543273|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543274|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543275|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543276|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543277|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543278|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543279|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543890|NCT00832455|O4|Outcome|Montelukast ITT at Week 12|
543281|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543282|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543283|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543284|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543285|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543286|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543287|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543288|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543289|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543290|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543291|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543292|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543293|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543294|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543295|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543296|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543297|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543298|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543299|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543300|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543301|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543302|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543303|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543304|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543305|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543306|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
543307|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543308|NCT00836693|E2|Reported Event|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration.
543309|NCT00836693|E1|Reported Event|Tadalafil|Tadalafil 5 milligrams administered orally once a day over 12 weeks. Dosing started at 5 mg tadalafil daily (or matching placebo) and could be down-titrated to 2.5 mg tadalafil daily (or matching placebo) based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
543310|NCT00836706|B3|Baseline|Total|Total of all reporting groups
543311|NCT00836706|B2|Baseline|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
543312|NCT00836706|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.
543313|NCT00836706|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
543314|NCT00836706|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.
543315|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
543316|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
543317|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
543318|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
543319|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
543320|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
543321|NCT00836719|B1|Baseline|Polyphenon E|"Standarized green tea extract containing 50% EGCG
Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.
Two capsules twice a day."
543322|NCT00836719|P1|Participant Flow|Polyphenon E|"Standarized green tea extract containing 50% EGCG
Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.
Two capsules twice a day."
543323|NCT00836719|O1|Outcome|Polyphenon E|"Standarized green tea extract containing 50% EGCG
Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.
Two capsules twice a day."
543324|NCT00836719|O1|Outcome|Polyphenon E|"Standarized green tea extract containing 50% EGCG
Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.
Two capsules twice a day."
543325|NCT00836719|E1|Reported Event|Polyphenon E|"Standarized green tea extract containing 50% EGCG
Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.
Two capsules twice a day."
543326|NCT00836745|B1|Baseline|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
543327|NCT00836745|P1|Participant Flow|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
543328|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
543329|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
543330|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
543331|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
543332|NCT00836745|E1|Reported Event|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
543333|NCT00836875|B3|Baseline|Total|Total of all reporting groups
543334|NCT00836875|B2|Baseline|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
543335|NCT00836875|B1|Baseline|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
543336|NCT00836875|P2|Participant Flow|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
543354|NCT00836901|P1|Participant Flow|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
543355|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
543337|NCT00836875|P1|Participant Flow|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
543338|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
543339|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
543340|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
543341|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
543342|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
543343|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
543344|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
543345|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
543346|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
543347|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
543348|NCT00836875|E2|Reported Event|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
543349|NCT00836875|E1|Reported Event|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
543350|NCT00836901|B3|Baseline|Total|Total of all reporting groups
543351|NCT00836901|B2|Baseline|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
543352|NCT00836901|B1|Baseline|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
543353|NCT00836901|P2|Participant Flow|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
543356|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
543357|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
543358|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
543359|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
543360|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
543361|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
543362|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
543363|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
543364|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
543365|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
543366|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
543367|NCT00836953|B1|Baseline|Study Group|Participants received study vaccine on Days 0 and 30.
543368|NCT00836953|P1|Participant Flow|Study Group|Participants received study vaccine on Days 0 and 30.
543369|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
543370|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
543371|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
543372|NCT00836953|E1|Reported Event|Study Group|Participants received study vaccine on Days 0 and 30.
543373|NCT00837031|B1|Baseline|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
543374|NCT00837031|P1|Participant Flow|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
543375|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
543376|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
543377|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
543378|NCT00837031|E1|Reported Event|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
543379|NCT00837148|B1|Baseline|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
543380|NCT00837148|P1|Participant Flow|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
543381|NCT00837148|O1|Outcome|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
543382|NCT00837148|E1|Reported Event|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
543383|NCT00837161|B1|Baseline|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
543384|NCT00837161|P1|Participant Flow|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
543385|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
543555|NCT00837876|P1|Participant Flow|Treatment|Sorafenib + Erlotinib
543386|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
543387|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
543388|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
543389|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
543390|NCT00837161|E1|Reported Event|HIFU Treatment|
543391|NCT00837200|B1|Baseline|Treatment|Oncaspar 2500 IU/m2 D1,15; Doxil 20mg/m2 D1,15; Decadron 20 mg D1,8,15,22
543392|NCT00837200|P1|Participant Flow|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
543393|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
543394|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
543395|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
543396|NCT00837200|E1|Reported Event|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
543397|NCT00837213|B3|Baseline|Total|Total of all reporting groups
543398|NCT00837213|B2|Baseline|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
543399|NCT00837213|B1|Baseline|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
543400|NCT00837213|P2|Participant Flow|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
543401|NCT00837213|P1|Participant Flow|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
543402|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
543403|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
543404|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
543405|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
543406|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
543407|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
543408|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
543409|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
543410|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
543411|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
543412|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
543413|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
543414|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
543415|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
543416|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
543417|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
543418|NCT00837213|E2|Reported Event|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
543419|NCT00837213|E1|Reported Event|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
543420|NCT00837252|B1|Baseline|Finasteride|
543421|NCT00837252|P1|Participant Flow|Finasteride|All five study participants (all of whom were diagnosed with chronic CSC) were administered a 5mg oral dose of finasteride daily for three months. After three months, the finasteride was withheld and the participants were observed for another three months.
543422|NCT00837252|O1|Outcome|Finasteride|
543423|NCT00837252|O1|Outcome|Finasteride|
543424|NCT00837252|O1|Outcome|Finasteride|
543425|NCT00837252|O1|Outcome|Finasteride|
543426|NCT00837252|O1|Outcome|Finasteride|
543427|NCT00837252|O1|Outcome|Finasteride|
543428|NCT00837252|O1|Outcome|Finasteride|
543429|NCT00837252|O1|Outcome|Finasteride|
543430|NCT00837252|O1|Outcome|Finasteride|
543431|NCT00837252|O1|Outcome|Finasteride|
543432|NCT00837252|O1|Outcome|Finasteride|
543433|NCT00837252|O1|Outcome|Finasteride|
543434|NCT00837252|E1|Reported Event|Finasteride|
543435|NCT00837330|B3|Baseline|Total|Total of all reporting groups
543436|NCT00837330|B2|Baseline|Ranibizumab 0.3 mg/ 0.05 cc|Intraocular injection of 0.3 mg /0.05 cc ranibizumab
543437|NCT00837330|B1|Baseline|Ranibizumab 0.5 mg/ 0.05 cc|Intraocular injection of 0.5 mg /0.05 cc ranibizumab
543438|NCT00837330|P2|Participant Flow|Intraocular Injection 0.3 mg Ranibizumab|10 patients will receive intraocular injection 0.3 mg ranibizumab
543439|NCT00837330|P1|Participant Flow|Intraocular Injection 0.5 mg Ranibizumab|10 patients will receive intraocular injection 0.5 mg ranibizumab
543440|NCT00837330|O2|Outcome|Ranibizumab 0.3 mg|Intraocular injection 0.3 mg ranibizumab
543441|NCT00837330|O1|Outcome|Ranibizumab 0.5 mg|Intraocular injection of 0.5 mg ranibizumab
543442|NCT00837330|E2|Reported Event|Ranibizumab 0.3 mg|Intravitreal Injection of Ranibizumab 0.5 mg
543443|NCT00837330|E1|Reported Event|Ranibizumab 0.5 mg|Intravitreal Injection of Ranibizumab 0.5 mg
543444|NCT00837434|B3|Baseline|Total|Total of all reporting groups
543445|NCT00837434|B2|Baseline|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
543446|NCT00837434|B1|Baseline|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
543447|NCT00837434|P2|Participant Flow|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
543448|NCT00837434|P1|Participant Flow|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
543449|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
543450|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
543451|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
543452|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
543453|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
543454|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
543455|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
543456|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
543457|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
543458|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
543459|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
543460|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
543461|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
543462|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
543463|NCT00837434|E2|Reported Event|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
543464|NCT00837434|E1|Reported Event|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
543465|NCT00837447|B1|Baseline|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
543466|NCT00837447|P1|Participant Flow|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
543467|NCT00837447|O2|Outcome|High-Flexion Posterior Cruciate Scrificing TKA|
543468|NCT00837447|O1|Outcome|High-Flexion Posterior Cruciate Retaining TKA|
543469|NCT00837447|E1|Reported Event|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
543470|NCT00837486|B3|Baseline|Total|Total of all reporting groups
543471|NCT00837486|B2|Baseline|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
543472|NCT00837486|B1|Baseline|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
543473|NCT00837486|P2|Participant Flow|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
543474|NCT00837486|P1|Participant Flow|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
543475|NCT00837486|O1|Outcome|All Enrolled Subjects|The 30 subjects were followed an average of 36 months after enrollment.
543476|NCT00837486|O1|Outcome|Long-term Open-label Treatment|All subjects received open-label active stimulation after the 16 week blinded-treatment phase.
543477|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
543478|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
543479|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
543480|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
543481|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
543482|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
543483|NCT00837486|E2|Reported Event|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
543484|NCT00837486|E1|Reported Event|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
543485|NCT00837512|B1|Baseline|Entire Study Population|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
543486|NCT00837512|P2|Participant Flow|First: Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
543487|NCT00837512|P1|Participant Flow|First: Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
543488|NCT00837512|O2|Outcome|Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
543489|NCT00837512|O1|Outcome|Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
543490|NCT00837512|E2|Reported Event|Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
543491|NCT00837512|E1|Reported Event|Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
543492|NCT00837577|B3|Baseline|Total|Total of all reporting groups
543493|NCT00837577|B2|Baseline|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
543494|NCT00837577|B1|Baseline|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
543495|NCT00837577|P2|Participant Flow|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
543496|NCT00837577|P1|Participant Flow|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
543497|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
543498|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
543499|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
543500|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
543501|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
543502|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
543556|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
543557|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
543558|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
543559|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
543503|NCT00837577|E3|Reported Event|Pooled Sitagliptin (Data Through Week 52)|The Pooled Sitagliptin group includes data from all participants who took sitagliptin in either treatment group: data from Week 0 to Week 52 for participants in the Sitagliptin/Sitagliptin group; data from Weeks 12 through Week 52 for participants in the Placebo/Sitagliptin group; and data from participants in either group who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
543504|NCT00837577|E2|Reported Event|Placebo/Sitagliptin (Data Through Week 12)|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
543505|NCT00837577|E1|Reported Event|Sitagliptin/Sitagliptin (Data Through Week 12)|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
543506|NCT00837616|B3|Baseline|Total|Total of all reporting groups
543507|NCT00837616|B2|Baseline|Group B|Group B received the transdermal estradiol for 12 months
543508|NCT00837616|B1|Baseline|Group A|Group A received the oral estradiol for 12 months
543509|NCT00837616|P2|Participant Flow|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
543510|NCT00837616|P1|Participant Flow|Oral Estradiol|Group A received the oral estradiol for 12 months
543511|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
543512|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
543513|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
543514|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
543515|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
543516|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
543517|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
543518|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
543519|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
543520|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
543521|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
543522|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
543523|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
543524|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
543525|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
543526|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
543527|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
543528|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
543529|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
543530|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
543531|NCT00837616|E2|Reported Event|Group B|Group B received the transdermal estradiol for 12 months
543532|NCT00837616|E1|Reported Event|Group A|Group A received the oral estradiol for 12 months
543533|NCT00837759|B1|Baseline|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
543534|NCT00837759|P1|Participant Flow|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
543535|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
543536|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
543537|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
543538|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
543539|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
543540|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
543541|NCT00837759|E1|Reported Event|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
543542|NCT00837824|B3|Baseline|Total|Total of all reporting groups
543543|NCT00837824|B2|Baseline|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
543544|NCT00837824|B1|Baseline|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
543545|NCT00837824|P2|Participant Flow|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
543546|NCT00837824|P1|Participant Flow|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
543547|NCT00837824|O2|Outcome|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
543548|NCT00837824|O1|Outcome|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
543549|NCT00837824|O2|Outcome|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
543550|NCT00837824|O1|Outcome|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
543551|NCT00837824|E3|Reported Event|Total|
543552|NCT00837824|E2|Reported Event|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
543553|NCT00837824|E1|Reported Event|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
543554|NCT00837876|B1|Baseline|Treatment|Sorafenib + Erlotinib
543562|NCT00837967|P2|Participant Flow|Terbutaline First, Then Symbicort|Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
543563|NCT00837967|P1|Participant Flow|Symbicort First, Then Terbutaline|Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
543564|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
543565|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
543566|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
543567|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
543568|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
543569|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
543570|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
543571|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
543572|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
543573|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
543574|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
543575|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
543576|NCT00837967|E2|Reported Event|Terbutaline|Terbutaline Turbuhaler 0.4 mg for 3 days
543577|NCT00837967|E1|Reported Event|Symbicort|Symbicort Turbuhaler 160/4.5μg for 3 days
543578|NCT00838097|B1|Baseline|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
543579|NCT00838097|P1|Participant Flow|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
543580|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
543581|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
543582|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
543583|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
543584|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
543585|NCT00838097|E1|Reported Event|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
543586|NCT00838110|B3|Baseline|Total|Total of all reporting groups
543587|NCT00838110|B2|Baseline|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
543588|NCT00838110|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
543589|NCT00838110|P4|Participant Flow|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
543590|NCT00838110|P3|Participant Flow|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
543591|NCT00838110|P2|Participant Flow|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
543592|NCT00838110|P1|Participant Flow|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
543593|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
543594|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
543595|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
543596|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
543597|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
543598|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
543599|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
543600|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
543642|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543891|NCT00832455|O3|Outcome|Montelukast ITT at Week 8|
543601|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg Dimebon (latrepirdine) tablet orally three times a day up to Week 12.
543602|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
543603|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
543604|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
543605|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
543606|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
543607|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
543608|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
543609|NCT00838110|E2|Reported Event|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
543610|NCT00838110|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
543611|NCT00838136|B3|Baseline|Total|Total of all reporting groups
543612|NCT00838136|B2|Baseline|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
543613|NCT00838136|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
543614|NCT00838136|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
543615|NCT00838136|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
543616|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
543617|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
543618|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
543619|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
543620|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
543621|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
543622|NCT00838162|B5|Baseline|Total|Total of all reporting groups
543623|NCT00838162|B4|Baseline|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543624|NCT00838162|B3|Baseline|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543625|NCT00838162|B2|Baseline|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543626|NCT00838162|B1|Baseline|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543627|NCT00838162|P4|Participant Flow|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543628|NCT00838162|P3|Participant Flow|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543629|NCT00838162|P2|Participant Flow|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543630|NCT00838162|P1|Participant Flow|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543631|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543632|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543633|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543634|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543635|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543636|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543637|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543638|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543639|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543640|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543641|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543892|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|
543643|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543644|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543645|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543646|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543647|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543648|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543649|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543650|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543651|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543652|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543653|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543654|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543655|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543656|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543657|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543658|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543659|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543660|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543661|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543662|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543663|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543664|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543665|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543666|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543667|NCT00838162|E4|Reported Event|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
543668|NCT00838162|E3|Reported Event|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
543669|NCT00838162|E2|Reported Event|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
543670|NCT00838162|E1|Reported Event|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
543671|NCT00838201|B3|Baseline|Total|Total of all reporting groups
543672|NCT00838201|B2|Baseline|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
543673|NCT00838201|B1|Baseline|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
543674|NCT00838201|P2|Participant Flow|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
543675|NCT00838201|P1|Participant Flow|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
543676|NCT00838201|O2|Outcome|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
543677|NCT00838201|O1|Outcome|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
543678|NCT00838201|E2|Reported Event|Denosumab/ Denosumab 60 mg Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
543679|NCT00838201|E1|Reported Event|Placebo/ Denosumab 60 mg Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
543680|NCT00838279|B3|Baseline|Total|Total of all reporting groups
543681|NCT00838279|B2|Baseline|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
543682|NCT00838279|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
543683|NCT00838279|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
543684|NCT00838279|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
543685|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
543686|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
543687|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
543688|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
543689|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
543690|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
543691|NCT00831987|B3|Baseline|Total|Total of all reporting groups
543893|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|
543692|NCT00831987|B2|Baseline|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543693|NCT00831987|B1|Baseline|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543694|NCT00831987|P2|Participant Flow|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543695|NCT00831987|P1|Participant Flow|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543696|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543697|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543698|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543699|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543700|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543701|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543702|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543703|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543704|NCT00831987|E2|Reported Event|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543705|NCT00831987|E1|Reported Event|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
543706|NCT00832000|B1|Baseline|All Study Participants|All participants received all inerventions; therefore, we combined all participants into one Arm/Group.
543707|NCT00832000|P2|Participant Flow|Placebo Then Mexiletine|"30 Participants will receive placebo for 4 weeks, then no intervention for 1 week, and finally mexiletine for 4 weeks.
Included in analysis* 29 patients
*Modified intention to treat analysis. 1 subject in each not included in primary analysis due to failure to make any calls to the IVR system for stiffness in either period."
543708|NCT00832000|P1|Participant Flow|Mexiletine Then Placebo|"29 Participants will receive mexiletine for 4 weeks, then no intervention for 1 week, and finally placebo for 4 weeks.
Included in anaysis*: 28 patients
*Modified intention to treat analysis. 1 subject in each group not included in primary analysis due to failure to make any calls to the IVR system for stiffness in either period"
543709|NCT00832000|O4|Outcome|Placebo - Period 2|SF-36 mental composite for participants receiving placebo capsules orally three times daily in period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
543710|NCT00832000|O3|Outcome|Mexiletine - Period 2|SF-36 mental composite for participants receiving mexiletine capsules 200 mg orally three times daily in period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
543711|NCT00832000|O2|Outcome|Placebo - Period 1|SF-36 mental composite for participants receiving placebo capsules orally three times daily in period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
543712|NCT00832000|O1|Outcome|Mexiletine - Period 1|SF-36 mental composite for participants receiving mexiletine capsules 200 mg orally three times daily in period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
543713|NCT00832000|O2|Outcome|Placebo|SF-36 physical composite score for participants receiving placebo capsules orally three times daily either in period 1 or period 2
543714|NCT00832000|O1|Outcome|Mexiletine|SF-36 physical composite score for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
543715|NCT00832000|O2|Outcome|Placebo|INQoL summary score for participants receiving placebo capsules orally three times daily either in period 1 or period 2
543716|NCT00832000|O1|Outcome|Mexiletine|INQoL summary score for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
543717|NCT00832000|O2|Outcome|Placebo|Post exercise CMAP amplitude ( as a percentage of baseline measurement) for participants receiving placebo capsules orally three times daily either in period 1 or period 2
543718|NCT00832000|O1|Outcome|Mexiletine|Post exercise CMAP amplitude (as a percentage of baseline measreument) for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
543719|NCT00832000|O2|Outcome|Placebo|Graded myotonia in right ADM for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
543720|NCT00832000|O1|Outcome|Mexiletine|Graded myotonia in right TA for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
543721|NCT00832000|O2|Outcome|Placebo|Average time to open eyes after forced eye closure for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
543722|NCT00832000|O1|Outcome|Mexiletine|Average time to open eyes after forced eye closure for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
543723|NCT00832000|O2|Outcome|Placebo|Average time to open the fist after forced hand grip for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
543724|NCT00832000|O1|Outcome|Mexiletine|Average time to open the fist after forced hand grip for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
543725|NCT00832000|O2|Outcome|Placebo|Graded myotonia in right ADM for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
543726|NCT00832000|O1|Outcome|Mexiletine|Graded myotonia in right ADM for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
543727|NCT00832000|O2|Outcome|Placebo|Post exercise CMAP amplitude (as a percento f baseline measurement) for particpants receiving mexiletine capsules orally three times daily either in period 1 or period 2
543728|NCT00832000|O1|Outcome|Mexiletine|Post exercise CMAP amplitude (as a percent of baseline measurement) for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
543729|NCT00832000|O2|Outcome|Placebo|Average 90% to 5% hand grip relaxation time for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
543730|NCT00832000|O1|Outcome|Mexiletine|Average 90% to 5% hand grip relaxation time for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
543731|NCT00832000|O2|Outcome|Placebo|Particiapnts who experienced tiredness on placebo capsules orally three times daily in either period 1 or period 2.
543732|NCT00832000|O1|Outcome|Mexiletine|Particiapnts who experienced tiredness on mexiletine 200 mg capsules orally three times daily in either period 1 or period 2.
543733|NCT00832000|O2|Outcome|Placebo|Particiapnts who experienced weakness on placebo capsules orally three times daily in either period 1 or period 2.
543734|NCT00832000|O1|Outcome|Mexiletine|Particiapnts who experienced weakness on mexiletine capsules 200 mg orally three times daily in either period 1 or period 2.
543735|NCT00832000|O2|Outcome|Placebo|Participants experiencing pain on placebo capsules orally three times dailyin period 1 or period 2
543736|NCT00832000|O1|Outcome|Mexiletine|Participants experiencing pain on mexiletine capsules 200 mg orally three times daily in period 1 or period 2
543737|NCT00832000|O4|Outcome|Placebo - Period 2|Placebo capsules orally three times dailyperiod 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
543738|NCT00832000|O3|Outcome|Mexiletine - Period 2|Mexiletine capsules 200 mg orally three times daily period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
543739|NCT00832000|O2|Outcome|Placebo - Period 1|Placebo capsules orally three times dailyperiod 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
543740|NCT00832000|O1|Outcome|Mexiletine - Period 1|Mexiletine capsules 200 mg orally three times daily period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
543741|NCT00832000|E2|Reported Event|Placebo Treatment|Adverse events that occurred when patients were taking mexiletine.
543742|NCT00832000|E1|Reported Event|Mexiletine Treatment|Adverse events that occurred when patients were taking placebo.
543743|NCT00832078|B1|Baseline|Entire Study Population|
543744|NCT00832078|P2|Participant Flow|Group B|Test day 1 first SC then SCCM; Test day 2 first SCCM then SC; this gives 4 catherizations per participant
543745|NCT00832078|P1|Participant Flow|Group A|Test day 1: first SCCM then SC; Test day 2: first SC then SCCM; this gives 4 catherizations per participant
543746|NCT00832078|O2|Outcome|Standard Catheter SC|The Stanard catheter SpeediCath (SC)
543747|NCT00832078|O1|Outcome|Test Catheter SCCM|The Test catheter SpeediCath Compact Male (SCCM)
543748|NCT00832078|E2|Reported Event|Standard Catheter|
543749|NCT00832078|E1|Reported Event|Test Catheter|
543750|NCT00832091|B3|Baseline|Total|Total of all reporting groups
543751|NCT00832091|B2|Baseline|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
543752|NCT00832091|B1|Baseline|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
543753|NCT00832091|P2|Participant Flow|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
543754|NCT00832091|P1|Participant Flow|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
543755|NCT00832091|O2|Outcome|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
543756|NCT00832091|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
543757|NCT00832091|O2|Outcome|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
543758|NCT00832091|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
543759|NCT00832091|E2|Reported Event|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
543760|NCT00832091|E1|Reported Event|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
543761|NCT00832117|B3|Baseline|Total|Total of all reporting groups
543762|NCT00832117|B2|Baseline|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
543763|NCT00832117|B1|Baseline|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
543764|NCT00832117|P1|Participant Flow|All Enrolled Participants|Participants received both ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 and ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle.
543765|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
543766|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
543767|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
543768|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
543769|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
543808|NCT00832299|B1|Baseline|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.
FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
543770|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
543771|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
543772|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
543773|NCT00832117|O1|Outcome|All Treated Participants|All participants who received at least 1 dose of either ixabepilone or carboplatin
543774|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
543775|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
543776|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
543777|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
543778|NCT00832117|E2|Reported Event|Ixa 32 mg/m2 +Cis 80 mg/m2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
543779|NCT00832117|E1|Reported Event|Ixa 32 mg/m2 + Cis 60 mg/m2|6 participants with solid tumor (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) for NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
543780|NCT00832130|B3|Baseline|Total|Total of all reporting groups
543781|NCT00832130|B2|Baseline|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
543782|NCT00832130|B1|Baseline|Manual Mini System|Treatment with experimental Manual Mini System
543783|NCT00832130|P2|Participant Flow|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
543784|NCT00832130|P1|Participant Flow|Manual Mini System|Treatment with experimental Manual Mini System
543785|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
543786|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
543787|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
543788|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
543789|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
543790|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
543791|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
543792|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
543793|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
543794|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
543795|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
543796|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
543797|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
543798|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
543799|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
543800|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
543801|NCT00832130|E2|Reported Event|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
543802|NCT00832130|E1|Reported Event|Manual Mini System|Treatment with experimental Manual Mini System
543803|NCT00832260|B1|Baseline|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
543804|NCT00832260|P1|Participant Flow|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
543805|NCT00832260|O1|Outcome|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
543806|NCT00832260|O1|Outcome|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
543807|NCT00832260|E1|Reported Event|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
543854|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
543809|NCT00832299|P1|Participant Flow|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.
FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
543810|NCT00832299|O1|Outcome|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.
FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
543811|NCT00832299|E1|Reported Event|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.
FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
543812|NCT00832338|B1|Baseline|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
543813|NCT00832338|P1|Participant Flow|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg twice daily (BID) PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
543814|NCT00832338|O1|Outcome|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
543815|NCT00832338|E1|Reported Event|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
543816|NCT00832377|B1|Baseline|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
543817|NCT00832377|P1|Participant Flow|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
543818|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
543819|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
543820|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
543821|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
543822|NCT00832377|E1|Reported Event|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
543823|NCT00832390|B4|Baseline|Total|Total of all reporting groups
543824|NCT00832390|B3|Baseline|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
543825|NCT00832390|B2|Baseline|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
543826|NCT00832390|B1|Baseline|Sitagliptin 100 mg q.d. (Once Daily)|
543827|NCT00832390|P3|Participant Flow|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
543828|NCT00832390|P2|Participant Flow|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
543829|NCT00832390|P1|Participant Flow|Sitagliptin 100 mg q.d. (Once Daily)|
543830|NCT00832390|O3|Outcome|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
543831|NCT00832390|O2|Outcome|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
543832|NCT00832390|O1|Outcome|Sitagliptin 100 mg q.d. (Once Daily)|
543833|NCT00832390|E3|Reported Event|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
543834|NCT00832390|E2|Reported Event|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
543835|NCT00832390|E1|Reported Event|Sitagliptin 100 mg q.d. (Once Daily)|
543836|NCT00832416|B5|Baseline|Total|Total of all reporting groups
543837|NCT00832416|B4|Baseline|4: Placebo|
543838|NCT00832416|B3|Baseline|3: Tramadol Once A Day 300mg|
543839|NCT00832416|B2|Baseline|2: Tramadol Once A Day 200mg|
543840|NCT00832416|B1|Baseline|1: Tramadol Once A Day 100mg|
543841|NCT00832416|P4|Participant Flow|4: Placebo|
543842|NCT00832416|P3|Participant Flow|3: Tramadol Once A Day 300mg|
543843|NCT00832416|P2|Participant Flow|2: Tramadol Once A Day 200mg|
543844|NCT00832416|P1|Participant Flow|1: Tramadol Once A Day 100mg|
543845|NCT00832416|O4|Outcome|4: Placebo|
543846|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
543847|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
543848|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
543849|NCT00832416|O4|Outcome|4: Placebo|
543850|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
543851|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
543852|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
543853|NCT00832416|O4|Outcome|4: Placebo|
543894|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|ITT population, receiving montelukast 4 or 5 mg/day
543895|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|ITT population, receiving montelukast 4 or 5 mg/day
543896|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|ITT population, receiving montelukast 4 or 5 mg/day
543897|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|ITT population, receiving montelukast 4 or 5 mg/day
543898|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|ITT population, receiving montelukast 4 or 5 mg/day
543899|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|ITT population, receiving montelukast 4 or 5 mg/day
543900|NCT00832455|E1|Reported Event|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
543901|NCT00832520|B1|Baseline|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
543902|NCT00832520|P1|Participant Flow|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
543903|NCT00832520|O1|Outcome|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
543904|NCT00832520|E1|Reported Event|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
543905|NCT00832572|B3|Baseline|Total|Total of all reporting groups
543906|NCT00832572|B2|Baseline|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
543907|NCT00832572|B1|Baseline|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
543908|NCT00832572|P2|Participant Flow|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
543909|NCT00832572|P1|Participant Flow|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
543910|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
543911|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
543912|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
543913|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
543914|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
543915|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
543916|NCT00832572|E4|Reported Event|Ranolazine/Placebo, Period 2|"Adverse events for this reporting group are those occurring during Period 2 (participants were receiving placebo).
Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2)."
543917|NCT00832572|E3|Reported Event|Ranolazine/Placebo, Period 1|"Adverse events for this reporting group are those occurring during Period 1 (participants were receiving ranolazine).
Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2)."
543918|NCT00832572|E2|Reported Event|Placebo/Ranolazine, Period 2|"Adverse events for this reporting group are those occurring during Period 2 (participants were receiving ranolazine).
Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2)."
543919|NCT00832572|E1|Reported Event|Placebo/Ranolazine, Period 1|"Adverse events for this reporting group are those occurring during Period 1 (participants were receiving placebo).
Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2)."
543920|NCT00832585|B1|Baseline|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
543921|NCT00832585|P1|Participant Flow|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
544022|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
544023|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
543922|NCT00832585|O1|Outcome|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
543923|NCT00832585|O1|Outcome|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
543924|NCT00832585|E1|Reported Event|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
543925|NCT00832624|B1|Baseline|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
543926|NCT00832624|P1|Participant Flow|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
543927|NCT00832624|O1|Outcome|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
543928|NCT00832624|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
543929|NCT00832637|B1|Baseline|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
543930|NCT00832637|P1|Participant Flow|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
543931|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
543932|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
543933|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
544024|NCT00842985|B1|Baseline|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.
Not all participants received the interventions in the same order."
544060|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
543934|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
543935|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
543936|NCT00832637|E1|Reported Event|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.
Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
Erlotinib: 100 mg orally daily.
Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
543937|NCT00832650|B4|Baseline|Total|Total of all reporting groups
543938|NCT00832650|B3|Baseline|Solifenacin|Solifenacin 10 mg capsule once daily
543939|NCT00832650|B2|Baseline|Placebo|Matched placebo tablet or capsule
543940|NCT00832650|B1|Baseline|Fesoterodine|Fesoterodine 8 mg tablet once daily
543941|NCT00832650|P3|Participant Flow|Solifenacin|Solifenacin 10 mg capsule once daily
543942|NCT00832650|P2|Participant Flow|Placebo|Matched placebo tablet or capsule
543943|NCT00832650|P1|Participant Flow|Fesoterodine|Fesoterodine 8 mg tablet once daily
543944|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
543945|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
543946|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
543947|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
543948|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
543949|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
543950|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
543951|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
543952|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
543953|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
543954|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
543955|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
543956|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
543957|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
543958|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
543959|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
543960|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
543961|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
543962|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
543963|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
543964|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
543965|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
543966|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
543967|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
543968|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
543969|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
543970|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
543971|NCT00832650|E3|Reported Event|Solifenacin|Solifenacin 10 mg capsule once daily
543972|NCT00832650|E2|Reported Event|Placebo|Matched placebo tablet or capsule
543973|NCT00832650|E1|Reported Event|Fesoterodine|Fesoterodine 8 mg tablet once daily
543974|NCT00838331|B1|Baseline|All Subjects|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
543975|NCT00838331|P1|Participant Flow|Fresh Blood, Then Aged Blood|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
543976|NCT00838331|O1|Outcome|Fresh Blood, Then Aged Blood|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
543977|NCT00838331|E1|Reported Event|All Subjects|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
543978|NCT00838513|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543979|NCT00838513|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543980|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543981|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543982|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543983|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543984|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543985|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543986|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543987|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543988|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543989|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543990|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543991|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543992|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543993|NCT00838513|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
543994|NCT00838526|B3|Baseline|Total|Total of all reporting groups
543995|NCT00838526|B2|Baseline|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
543996|NCT00838526|B1|Baseline|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
543997|NCT00838526|P2|Participant Flow|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
543998|NCT00838526|P1|Participant Flow|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
543999|NCT00838526|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
544000|NCT00838526|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
544001|NCT00838526|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
544002|NCT00838526|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
544003|NCT00838526|E2|Reported Event|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
544004|NCT00838526|E1|Reported Event|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
544005|NCT00838578|B1|Baseline|KRN330 + Irinotecan|open label, single arm
544006|NCT00838578|P1|Participant Flow|KRN330 + Irinotecan|"Phase 1____ Biweekly KRN330 (0.5 mg/kg) (N=8) Weekly KRN330 (0.5 mg/kg) (N=7) Biweekly KRN330 (1.0 mg/kg) (N=4) Total (N=19)
Phase 2____ Weekly KRN330 (0.5 mg/kg)) (N=46)
Phase 1 and 2Combined (N=65)"
544007|NCT00838578|O3|Outcome|PH 2 Treatment: KRN330 Wkly + IRI Biwkly|The Phase 2 portion was a single arm study using the regimen and dose selected in Phase 1 (0.5 mg/kg KRN330 weekly and 180 mg/m2 irinotecan biweekly).
544008|NCT00838578|O2|Outcome|Regimen B: KRN330 Weekly + Irinotecan Biweekly|treatment regimen B, KRN330 was administered weekly (Weeks 1, 2, 3, 4 and 5) and irinotecan (180 mg/m2) biweekly (Weeks 1, 3, and 5).
544009|NCT00838578|O1|Outcome|Regimen A: KRN330 Biweekly + Irinotecan Biweekly|"In treatment regimen A, both KRN330 and irinotecan (180 mg/m2) were administered biweekly(Weeks 1, 3, and 5).
Cohort 1: 1 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly Cohort 2: 0.5 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly"
544010|NCT00838578|E3|Reported Event|Phase 2: KRN330 Weekly + IRI Biweekly|The Phase 2 portion had a single arm in which patients received Regimen B as included in the Phase 1 portion
544011|NCT00838578|E2|Reported Event|Phase 1 Regimen B: KRN330 Weekly + IRI Biweekly|In Regimen B, patients received KRN330 0.5 mg/kg weekly (Weeks 1, 2, 3, 4, and 5) and irinotecan 180 mg/m2 biweekly (Weeks 1, 3, and 5)
544012|NCT00838578|E1|Reported Event|Phase 1 Regimen A: KRN330 Biweekly + IRI Biweekly|"In Regimen A, patients received both KRN330 and irinotecan biweekly (Weeks 1, 3, and 5):
Cohort 1: KRN330 1.0 mg/kg + irinotecan 180 mg/m2 Cohort 2: KRN330 0.5 mg/kg + irinotecan 180 mg/m2"
544013|NCT00838630|B3|Baseline|Total|Total of all reporting groups
544014|NCT00838630|B2|Baseline|Pletal® (Reference) First|Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
544015|NCT00838630|B1|Baseline|Cilostazol (Test) First|Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
544016|NCT00838630|P2|Participant Flow|Pletal® (Reference) First|Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
544017|NCT00838630|P1|Participant Flow|Cilostazol (Test) First|Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
544018|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
544019|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
544020|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
544021|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
544025|NCT00842985|P1|Participant Flow|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.
Not all participants received the interventions in the same order."
544026|NCT00842985|O4|Outcome|Placebo+Placebo|Session where placebo THC and Placebo Modafinil were given.
544027|NCT00842985|O3|Outcome|Pla+Modafinil|Session where Placebo THC and Modafinil were given
544028|NCT00842985|O2|Outcome|THC+Placebo|Session where TCH and Placebo Modafinil were given
544029|NCT00842985|O1|Outcome|THC+Modafinil|Session where THC+Modafinil was given.
544030|NCT00842985|E1|Reported Event|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.
Not all participants received the interventions in the same order."
544031|NCT00843024|B5|Baseline|Total|Total of all reporting groups
544032|NCT00843024|B4|Baseline|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544033|NCT00843024|B3|Baseline|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544034|NCT00843024|B2|Baseline|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544035|NCT00843024|B1|Baseline|Placebo|A single matching placebo tablet taken within a 12-week period
544036|NCT00843024|P6|Participant Flow|Sumatriptan 85 mg/ Naproxen 500 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544037|NCT00843024|P5|Participant Flow|Sumatriptan 30 mg/ Naproxen 180 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544038|NCT00843024|P4|Participant Flow|Sumatriptan 10 mg/ Naproxen 60 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544039|NCT00843024|P3|Participant Flow|Placebo|After completing the single-blind phase, participants received a single matching placebo tablet taken within a 12-week period
544040|NCT00843024|P2|Participant Flow|15 to 17 Years Age Group: Single-blind Phase|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
544041|NCT00843024|P1|Participant Flow|12 to 14 Years Age Group: Single-blind Phase|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
544042|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
544043|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
544044|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
544045|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
544046|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
544047|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
544048|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
544049|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
544050|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544051|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544052|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544053|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544054|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
544055|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
544056|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544057|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544058|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544059|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544061|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544062|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544063|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544064|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544065|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544066|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544067|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544068|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544069|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544070|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544071|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544072|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544073|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544074|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544075|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544076|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544077|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544078|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544079|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544080|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544081|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544082|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544083|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544084|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544085|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544086|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544087|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544088|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544089|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544090|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544091|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544092|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544093|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544094|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544095|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544096|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544097|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544098|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544099|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
544100|NCT00843024|E5|Reported Event|Single-blind Run-In Phase Placebo|One tablet of single-blind placebo taken during the Run-In Phase
544101|NCT00843024|E4|Reported Event|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
544102|NCT00843024|E3|Reported Event|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
544103|NCT00843024|E2|Reported Event|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
544104|NCT00843024|E1|Reported Event|Placebo|A single matching double-blind placebo tablet taken within a 12-week period
544105|NCT00843050|B1|Baseline|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
544106|NCT00843050|P1|Participant Flow|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
544107|NCT00843050|O1|Outcome|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
544108|NCT00843050|O1|Outcome|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
544109|NCT00843050|O1|Outcome|P276-00|P276-00: All patients received P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there was progression of disease or unacceptable toxicity
544110|NCT00843050|E1|Reported Event|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
544111|NCT00843115|B1|Baseline|Donepezil|As per physician prescription
544112|NCT00843115|P1|Participant Flow|Donepezil|As per physician prescription
544113|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544114|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544115|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544116|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544117|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544118|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544119|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544120|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544121|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544122|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544123|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544124|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544125|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544126|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544127|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544128|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544129|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544130|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544131|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544132|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544133|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544134|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544135|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544136|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544137|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544138|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544139|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544140|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544141|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544142|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544143|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544144|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544145|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544146|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544147|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544148|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544149|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544150|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544151|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544152|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544153|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544154|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544155|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
544156|NCT00843115|E1|Reported Event|Donepezil|As per physician prescription
544157|NCT00843167|B3|Baseline|Total|Total of all reporting groups
544158|NCT00843167|B2|Baseline|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
544159|NCT00843167|B1|Baseline|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
broccoli sprout extract: Given orally"
544160|NCT00843167|P2|Participant Flow|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
544161|NCT00843167|P1|Participant Flow|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
broccoli sprout extract: Given orally"
544162|NCT00843167|O2|Outcome|Treatment|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
544203|NCT00843349|B2|Baseline|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
544163|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
broccoli sprout extract: Given orally"
544164|NCT00843167|O2|Outcome|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
544165|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
broccoli sprout extract: Given orally"
544166|NCT00843167|O3|Outcome|Invasive Ductal Carcinoma Tissue; Ki-67|Sulforaphane Supplement= 7, Placebo= 6
544167|NCT00843167|O2|Outcome|DCIS Tissue; Ki-67|Sulforaphane Supplement= 6, Placebo = 13
544168|NCT00843167|O1|Outcome|Benign Tissue; Ki-67|Sulforaphane Supplement = 23, Placebo = 25
544169|NCT00843167|O2|Outcome|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
544170|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
broccoli sprout extract: Given orally"
544171|NCT00843167|E2|Reported Event|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
544172|NCT00843167|E1|Reported Event|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
broccoli sprout extract: Given orally"
544173|NCT00843180|B3|Baseline|Total|Total of all reporting groups
544174|NCT00843180|B2|Baseline|Control|usual care only as control arm hospital care during bone marrow transplant
544175|NCT00843180|B1|Baseline|Massage|massage and acupressure up to 3x/week for entire hospital stay
544176|NCT00843180|P2|Participant Flow|Control|usual care only as control arm hospital care during bone marrow transplant
544177|NCT00843180|P1|Participant Flow|Massage|massage and acupressure up to 3x/week for entire hospital stay
544178|NCT00843180|O2|Outcome|Control|
544179|NCT00843180|O1|Outcome|Massage|
544180|NCT00843180|O2|Outcome|Control|
544181|NCT00843180|O1|Outcome|Massage|
544182|NCT00843180|O2|Outcome|Control|
544183|NCT00843180|O1|Outcome|Massage|
544184|NCT00843180|O2|Outcome|Control|
544185|NCT00843180|O1|Outcome|Massage|
544186|NCT00843180|E2|Reported Event|Control|usual care only as control arm hospital care during bone marrow transplant
544187|NCT00843180|E1|Reported Event|Massage|massage and acupressure up to 3x/week for entire hospital stay
544188|NCT00843284|B1|Baseline|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
544189|NCT00843284|P1|Participant Flow|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
544190|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
544191|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
544192|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
544193|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
544194|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
544195|NCT00843284|E1|Reported Event|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
544196|NCT00843310|B1|Baseline|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):
Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.
Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):
lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
544197|NCT00843310|P1|Participant Flow|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):
Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.
Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):
lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
544198|NCT00843310|O1|Outcome|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):
Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.
Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):
lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
544199|NCT00843310|E1|Reported Event|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):
Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.
Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):
lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
544200|NCT00843349|B5|Baseline|Total|Total of all reporting groups
544201|NCT00843349|B4|Baseline|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
544202|NCT00843349|B3|Baseline|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
553652|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
544204|NCT00843349|B1|Baseline|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
544205|NCT00843349|P4|Participant Flow|Ad Libitum Diet-Lanthanum Carbonate Placebo|no dietary intervention + Lanthanum Carbonate placebo
544206|NCT00843349|P3|Participant Flow|900 mg Phosphate Diet-Lanthanum Carbonate Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + Lanthanum Carbonate placebo
544207|NCT00843349|P2|Participant Flow|Ad Libitum Diet-Lanthanum Carbonate|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
544208|NCT00843349|P1|Participant Flow|900 mg Phosphate Diet-Lanthanum Carbonate (LC)|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
544209|NCT00843349|O4|Outcome|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
544210|NCT00843349|O3|Outcome|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
544211|NCT00843349|O2|Outcome|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
544212|NCT00843349|O1|Outcome|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
544213|NCT00843349|O4|Outcome|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
544214|NCT00843349|O3|Outcome|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
544215|NCT00843349|O2|Outcome|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
544216|NCT00843349|O1|Outcome|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
544217|NCT00843349|E4|Reported Event|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
544218|NCT00843349|E3|Reported Event|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
544219|NCT00843349|E2|Reported Event|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
544220|NCT00843349|E1|Reported Event|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
544221|NCT00843466|B3|Baseline|Total|Total of all reporting groups
544222|NCT00843466|B2|Baseline|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
544223|NCT00843466|B1|Baseline|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
544224|NCT00843466|P2|Participant Flow|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
544225|NCT00843466|P1|Participant Flow|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
544226|NCT00843466|O2|Outcome|No Treatment|The control group continued to use their current cleanser for hand washing.
544227|NCT00843466|O1|Outcome|Mild Moisturizing Hand Cleanser Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
544228|NCT00843466|E2|Reported Event|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
544229|NCT00843466|E1|Reported Event|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
544230|NCT00843479|B3|Baseline|Total|Total of all reporting groups
544231|NCT00843479|B2|Baseline|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
544232|NCT00843479|B1|Baseline|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
544233|NCT00843479|P2|Participant Flow|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
544234|NCT00843479|P1|Participant Flow|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
544235|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
544236|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
544237|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
544238|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
544239|NCT00843479|O2|Outcome|Middle-age NGT|Middle-age normoglycemic subjects 35 to 50 years old
544240|NCT00843479|O1|Outcome|Elderly NGT|Normoglycemic subjects 65-80 years old
544241|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
544242|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
544243|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
544244|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
544245|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
544246|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
544247|NCT00843479|E2|Reported Event|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
544248|NCT00843479|E1|Reported Event|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
544249|NCT00843492|B3|Baseline|Total|Total of all reporting groups
544250|NCT00843492|B2|Baseline|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
544251|NCT00843492|B1|Baseline|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
544252|NCT00843492|P2|Participant Flow|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
544398|NCT00844051|E2|Reported Event|Intervention|School-based Influenza Vaccination Program
544253|NCT00843492|P1|Participant Flow|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
544254|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
544255|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
544256|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
544257|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
544258|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
544259|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
544260|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
544261|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
544262|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
544263|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
544264|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
544265|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
544266|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
544267|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
544268|NCT00843492|E2|Reported Event|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
544269|NCT00843492|E1|Reported Event|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
544270|NCT00843622|B3|Baseline|Total|Total of all reporting groups
544271|NCT00843622|B2|Baseline|Placebo Snus|Non-tobacco, non-nicotine placebo product
544272|NCT00843622|B1|Baseline|Active Snus|Tobacco-based, smokefree product
544273|NCT00843622|P2|Participant Flow|Placebo Snus|Non-tobacco, non-nicotine placebo product
544274|NCT00843622|P1|Participant Flow|Active Snus|Tobacco-based, smokefree product
544275|NCT00843622|O2|Outcome|Placebo Snus|Non-tobacco, non-nicotine placebo product
544276|NCT00843622|O1|Outcome|Active Snus|Tobacco-based, smokefree product
544277|NCT00843622|E2|Reported Event|Placebo Snus|Non-tobacco, non-nicotine placebo product
544278|NCT00843622|E1|Reported Event|Active Snus|Tobacco-based, smokefree product
544279|NCT00843635|B4|Baseline|Total|Total of all reporting groups
544280|NCT00843635|B3|Baseline|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally"
544281|NCT00843635|B2|Baseline|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544282|NCT00843635|B1|Baseline|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544283|NCT00843635|P3|Participant Flow|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally"
544284|NCT00843635|P2|Participant Flow|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544285|NCT00843635|P1|Participant Flow|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544286|NCT00843635|O3|Outcome|Arm C - Placebo|Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
544287|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
544288|NCT00843635|O1|Outcome|Arm A - 10mg|Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
544289|NCT00843635|O1|Outcome|Arm A (Tadalafil 10mg) + Arm B (Tadalafil 20mg)|All participants enrolled to the two dosing arms, Arm A (Tadalafil 10 mg) and Arm B (Tadalafil 20 mg).
544290|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally"
544291|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544292|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544293|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally"
544294|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544295|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544296|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally"
544297|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544298|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544299|NCT00843635|E3|Reported Event|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally"
544300|NCT00843635|E2|Reported Event|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544301|NCT00843635|E1|Reported Event|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally"
544302|NCT00843713|B3|Baseline|Total|Total of all reporting groups
544303|NCT00843713|B2|Baseline|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication
raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
544304|NCT00843713|B1|Baseline|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication
Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
544305|NCT00843713|P2|Participant Flow|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication
raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
544306|NCT00843713|P1|Participant Flow|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication
Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
544307|NCT00843713|O2|Outcome|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication
raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
544308|NCT00843713|O1|Outcome|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication
Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
544309|NCT00843713|E2|Reported Event|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication
raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
544310|NCT00843713|E1|Reported Event|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication
Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
544311|NCT00843778|B1|Baseline|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544312|NCT00843778|P1|Participant Flow|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544399|NCT00844051|E1|Reported Event|No Intervention|No school-based influenza vaccination program
544400|NCT00844090|B3|Baseline|Total|Total of all reporting groups
544313|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544314|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544315|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544316|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544317|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544318|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544319|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544320|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544321|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544322|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544323|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544324|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544401|NCT00844090|B2|Baseline|Placebo|"placebo
methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
544402|NCT00844090|B1|Baseline|Methylphenidate|"methylphenidate
methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
545735|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
544325|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544326|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544327|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544328|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544329|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544330|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544331|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544332|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544333|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544334|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544335|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544336|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544403|NCT00844090|P2|Participant Flow|Placebo|"placebo
placebo only to treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
544404|NCT00844090|P1|Participant Flow|Methylphenidate|"methylphenidate
methylphenidate 10mg twice daily P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
553653|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
544337|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544338|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544339|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544340|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544341|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544342|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
544343|NCT00843778|E1|Reported Event|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks
Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).
Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks."
544344|NCT00843830|B1|Baseline|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
544345|NCT00843830|P1|Participant Flow|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
544346|NCT00843830|O1|Outcome|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
544347|NCT00843830|O1|Outcome|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
544405|NCT00844090|O2|Outcome|Placebo|"placebo
Placebo tabs BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
553654|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
544348|NCT00843830|E1|Reported Event|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
544349|NCT00843843|B3|Baseline|Total|Total of all reporting groups
544350|NCT00843843|B2|Baseline|3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
544351|NCT00843843|B1|Baseline|9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
544352|NCT00843843|P2|Participant Flow|3 Hour Nap and 6 Hour Sleep (3days), Then 9 Hour Sleep (3days)|3 hour nap and 6 hour sleep (3days), then 9 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
544353|NCT00843843|P1|Participant Flow|9 Hour Sleep (3days), Then 3 Hour Nap and 6 Hour Sleep (3days)|9 hour sleep (3days), then 3 hour nap and 6 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
544354|NCT00843843|O2|Outcome|3 Hour Nap and 6 Hour Sleep|
544355|NCT00843843|O1|Outcome|9 Hour Sleep|
544356|NCT00843843|O2|Outcome|3 Hour Nap and 6 Hour Sleep|
544357|NCT00843843|O1|Outcome|9 Hour Sleep|
544358|NCT00843843|E2|Reported Event|3 Hour Nap and 6 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
544359|NCT00843843|E1|Reported Event|9 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
544360|NCT00843986|B3|Baseline|Total|Total of all reporting groups
544361|NCT00843986|B2|Baseline|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544362|NCT00843986|B1|Baseline|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544363|NCT00843986|P2|Participant Flow|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544364|NCT00843986|P1|Participant Flow|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544365|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544366|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544367|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544368|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544369|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544370|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544371|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544372|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544373|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544374|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544375|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544376|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544377|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544378|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544379|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544380|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544381|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544382|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544383|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544384|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544385|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544386|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544387|NCT00843986|E2|Reported Event|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
544388|NCT00843986|E1|Reported Event|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
544389|NCT00844051|B3|Baseline|Total|Total of all reporting groups
544390|NCT00844051|B2|Baseline|Intervention|"School-based Influenza Vaccination Program
School-based influenza vaccination program: School-based influenza vaccination program"
544391|NCT00844051|B1|Baseline|No Intervention|No school-based influenza vaccination program
544392|NCT00844051|P2|Participant Flow|Intervention|School-based Influenza Vaccination Program
544393|NCT00844051|P1|Participant Flow|No Intervention|No school-based influenza vaccination program
544394|NCT00844051|O2|Outcome|Intervention|School-based Influenza Vaccination Program
544395|NCT00844051|O1|Outcome|No Intervention|No school-based influenza vaccination program
544396|NCT00844051|O2|Outcome|Intervention|School-based Influenza Vaccination Program
544397|NCT00844051|O1|Outcome|No Intervention|No school-based influenza vaccination program
553655|NCT00862082|O1|Outcome|PR104|
544406|NCT00844090|O1|Outcome|Methylphenidate|"methylphenidate
methylphenidate 10mg BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
544407|NCT00844090|E2|Reported Event|Placebo|"placebo
Placebo bid p.o. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
544408|NCT00844090|E1|Reported Event|Methyphenidate|"methylphenidate
methylphenidate 10mg bid p.o.: treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
544409|NCT00844194|B3|Baseline|Total|Total of all reporting groups
544410|NCT00844194|B2|Baseline|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544411|NCT00844194|B1|Baseline|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544412|NCT00844194|P2|Participant Flow|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544413|NCT00844194|P1|Participant Flow|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544414|NCT00844194|O4|Outcome|MDD+ Non-Responder|MDD+, not treatment responder. 60mg, after week 5 120mg DLX
544415|NCT00844194|O3|Outcome|MDD- Non-Responder|MDD-, not treatment responder. 60mg, after week 5 120mg DLX
544416|NCT00844194|O2|Outcome|MDD+ Responder|MDD+, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
544417|NCT00844194|O1|Outcome|MDD- Responder|MDD-, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
544418|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544419|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544420|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544421|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544422|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544423|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544424|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544425|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544426|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544427|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544428|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544429|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544430|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544431|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544432|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544433|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544434|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544435|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544436|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544437|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544438|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544439|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544440|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544441|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544442|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544443|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544444|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544445|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544446|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544447|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544448|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544449|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544450|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544451|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544452|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544453|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544454|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544455|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544456|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544457|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544458|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544459|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544460|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544461|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544462|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544463|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544464|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544465|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544466|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544467|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544468|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544469|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544470|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544471|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544472|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544473|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544474|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544475|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544476|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544477|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544478|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544479|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544480|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544481|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544482|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544483|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544484|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544485|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544486|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544487|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544488|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544489|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544490|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544491|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544492|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544493|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544494|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544495|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544496|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544497|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544498|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544499|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544500|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544501|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544502|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544503|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544504|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544505|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544506|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544507|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544508|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544509|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544510|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544511|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
556506|NCT00871871|B3|Baseline|Total|Total of all reporting groups
544512|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544513|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544514|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544515|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544516|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544517|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544518|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544519|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544520|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544521|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544522|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544523|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544524|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544525|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544526|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544527|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544528|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544529|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544530|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544531|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544532|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544533|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544534|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544535|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544536|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544537|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544538|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544539|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544540|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544541|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544542|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544543|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544544|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544545|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544546|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544547|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544548|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544549|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544550|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544551|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544552|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544553|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544554|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544555|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544556|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544557|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544558|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544559|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544560|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544561|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544562|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544563|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544564|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
557818|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
544565|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544566|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544567|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544568|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544569|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544570|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544571|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544572|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544573|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544574|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544575|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544576|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544577|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544578|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544579|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544580|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544581|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544582|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544583|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544584|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544585|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544586|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544587|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544588|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544589|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544590|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544591|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544592|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544593|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544594|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544595|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544596|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544597|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544598|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544599|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544600|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544601|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544602|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544603|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544604|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544605|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544606|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544607|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544608|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544609|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544610|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544611|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544612|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544613|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544614|NCT00844194|E2|Reported Event|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
544615|NCT00844194|E1|Reported Event|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
544691|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544616|NCT00844298|B1|Baseline|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan
Nilotinib+mVPD: 1.Induction:
Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)
Vincristine 2 mg iv push (d1, 8, 15, 22)
Prednisolone 60 mg/m2/day po (d1-28)
Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)
Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)
Vincristine 2 mg iv (d1, 8)
Prednisolone 60 mg/m2/day po (d1-14)
Nilotinib 400mg bid/d
3. Consolidation B (cycles 2&4)
Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)
Etoposide 150 mg/m2/day iv over 3 hours (d1-4)
Nilotinib 400mg bid/d
4.Consolidation C (cycles 3&5)
Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)
Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,
Nilotinib 400mg bid/d
5.Maintenance
Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)
6.Consider alloHCT"
544617|NCT00844298|P1|Participant Flow|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan
Nilotinib+mVPD: 1.Induction:
Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)
Vincristine 2 mg iv push (d1, 8, 15, 22)
Prednisolone 60 mg/m2/day po (d1-28)
Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)
Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)
Vincristine 2 mg iv (d1, 8)
Prednisolone 60 mg/m2/day po (d1-14)
Nilotinib 400mg bid/d
3. Consolidation B (cycles 2&4)
Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)
Etoposide 150 mg/m2/day iv over 3 hours (d1-4)
Nilotinib 400mg bid/d
4.Consolidation C (cycles 3&5)
Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)
Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,
Nilotinib 400mg bid/d
5.Maintenance
Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)
6.Consider alloHCT"
544618|NCT00844298|O1|Outcome|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan
Nilotinib+mVPD: 1.Induction:
Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)
Vincristine 2 mg iv push (d1, 8, 15, 22)
Prednisolone 60 mg/m2/day po (d1-28)
Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)
Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)
Vincristine 2 mg iv (d1, 8)
Prednisolone 60 mg/m2/day po (d1-14)
Nilotinib 400mg bid/d
3. Consolidation B (cycles 2&4)
Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)
Etoposide 150 mg/m2/day iv over 3 hours (d1-4)
Nilotinib 400mg bid/d
4.Consolidation C (cycles 3&5)
Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)
Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,
Nilotinib 400mg bid/d
5.Maintenance
Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)
6.Consider alloHCT"
544619|NCT00844298|E1|Reported Event|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan
Nilotinib+mVPD: 1.Induction:
Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)
Vincristine 2 mg iv push (d1, 8, 15, 22)
Prednisolone 60 mg/m2/day po (d1-28)
Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)
Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)
Vincristine 2 mg iv (d1, 8)
Prednisolone 60 mg/m2/day po (d1-14)
Nilotinib 400mg bid/d
3. Consolidation B (cycles 2&4)
Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)
Etoposide 150 mg/m2/day iv over 3 hours (d1-4)
Nilotinib 400mg bid/d
4.Consolidation C (cycles 3&5)
Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)
Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,
Nilotinib 400mg bid/d
5.Maintenance
Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)
6.Consider alloHCT"
544620|NCT00844376|B1|Baseline|All Participants|
544621|NCT00844376|P2|Participant Flow|Reference Drug First (Atorvastatin Tablet)|80-mg Commercial atorvastatin tablet (Lipitor®) as a single dose in the first intervention period and 80-mg EP suspension atorvastatin prototype formulation as a single dose in the second intervention period. Period 2 began immediately after period 1.
544622|NCT00844376|P1|Participant Flow|Test Drug First (Atorvastatin EP Suspension)|80-milligram (mg) Extemporaneous preparation (EP) suspension atorvastatin prototype formulation as a single dose in the first intervention period and commercial (reference) 80 mg atorvastatin tablet (Lipitor®) as a single dose in the second intervention period. Period 2 began immediately after period 1.
544623|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
544624|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
544625|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
544626|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
544627|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
544628|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
544629|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
544630|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
544631|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
544632|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
544633|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
544634|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
544635|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
544636|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
544637|NCT00844376|E2|Reported Event|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
544638|NCT00844376|E1|Reported Event|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
544639|NCT00844415|B1|Baseline|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
544801|NCT00844558|O1|Outcome|Gait|"Gait Training Arm
Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
544802|NCT00844558|O2|Outcome|Control Group|No adverse events
544640|NCT00844415|P1|Participant Flow|All Patients (Pat.)|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
544641|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
544642|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
544643|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
544644|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
544645|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
544646|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
544647|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
544648|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
544803|NCT00844558|O1|Outcome|Gait|No adverse events
544831|NCT00844597|E4|Reported Event|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
544649|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
544650|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
544651|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
544652|NCT00844415|E1|Reported Event|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
544653|NCT00844428|B1|Baseline|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544654|NCT00844428|P1|Participant Flow|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544655|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544656|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544657|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544658|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544659|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544660|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544692|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544661|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544662|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544663|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544664|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544665|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544666|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544667|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544668|NCT00844428|E1|Reported Event|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544669|NCT00844480|B3|Baseline|Total|Total of all reporting groups
544670|NCT00844480|B2|Baseline|Placebo|placebo: iv
544671|NCT00844480|B1|Baseline|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
544672|NCT00844480|P2|Participant Flow|Placebo|placebo: iv
544673|NCT00844480|P1|Participant Flow|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
544674|NCT00844480|O2|Outcome|Placebo|placebo: iv
544675|NCT00844480|O1|Outcome|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
544676|NCT00844480|O2|Outcome|Placebo|placebo: iv
544677|NCT00844480|O1|Outcome|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
544678|NCT00844480|E2|Reported Event|Placebo|placebo: iv
544679|NCT00844480|E1|Reported Event|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
544680|NCT00844519|B3|Baseline|Total|Total of all reporting groups
544681|NCT00844519|B2|Baseline|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
544682|NCT00844519|B1|Baseline|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
544683|NCT00844519|P2|Participant Flow|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
544684|NCT00844519|P1|Participant Flow|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
544685|NCT00844519|O2|Outcome|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
544686|NCT00844519|O1|Outcome|Maraviroc|maraviroc 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
544687|NCT00844519|E2|Reported Event|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
544688|NCT00844519|E1|Reported Event|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
544689|NCT00844532|B1|Baseline|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544690|NCT00844532|P1|Participant Flow|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544693|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544694|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544695|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544696|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544697|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544698|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544699|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544700|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544701|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544702|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544703|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544704|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544705|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544706|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544707|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544708|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544709|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544710|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544711|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544712|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544713|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544798|NCT00844558|O2|Outcome|Control|"Control Group
Control: There is no intervention associated with this arm of the study"
544861|NCT00844753|B4|Baseline|Placebo Without Parent Management Training|Sugar pill administered twice daily.
544714|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544715|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544716|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544717|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544718|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544719|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544720|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544721|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544722|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544723|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544724|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544725|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544726|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544727|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544728|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544729|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544730|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544731|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544732|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544733|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544734|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544799|NCT00844558|O1|Outcome|Gait|"Gait Training Arm
Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
545736|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
544735|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544736|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544737|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544738|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544739|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544740|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544741|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544742|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544743|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544744|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544745|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544746|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544747|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544748|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544749|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544750|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544751|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544752|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544753|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544754|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544755|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544800|NCT00844558|O2|Outcome|Control|"Control Group
Control: There is no intervention associated with this arm of the study"
545006|NCT00844896|P2|Participant Flow|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
544756|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544757|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544758|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544759|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544760|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544761|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544762|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544763|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544764|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544765|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544766|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544767|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544768|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544769|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544770|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544771|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544772|NCT00844532|E1|Reported Event|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
544773|NCT00844545|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544774|NCT00844545|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544775|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
545007|NCT00844896|P1|Participant Flow|DEF-only|Distress Emotional Support and Family Assessment Treatment
544776|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
544777|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
544778|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
544779|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
544780|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
544781|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
544782|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
544783|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
544784|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
544785|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
544786|NCT00844545|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544787|NCT00844558|B3|Baseline|Total|Total of all reporting groups
544788|NCT00844558|B2|Baseline|Control|The control participants received their usual care for symptomatic knee osteoarthritis (OA) through their usual healthcare providers and were not asked to make changes to their lifestyle.Usual care for these subjects may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery, and/or physical therapy.
544789|NCT00844558|B1|Baseline|Gait|The gait participants were randomized and attended 24 biweekly 45-minute sessions directed by a physical therapist, which were composed of guided strategies to optimize knee movements during treadmill walking, using computerized motion analysis with visual biofeedback.
544790|NCT00844558|P2|Participant Flow|Control|"Control Group
Control: There is no intervention associated with this arm of the study"
544791|NCT00844558|P1|Participant Flow|Gait|"Gait Training Arm
Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
544792|NCT00844558|O2|Outcome|Control|"Control Group
Control: There is no intervention associated with this arm of the study"
544793|NCT00844558|O1|Outcome|Gait|"Gait Training Arm
Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
544794|NCT00844558|O2|Outcome|Control|"Gait Training Control Group Participants
Control: There is no intervention associated with this arm of the study"
544795|NCT00844558|O1|Outcome|Gait Training|"Gait Training Intervention Group Participants
Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
544796|NCT00844558|O2|Outcome|Control|No adverse events
544797|NCT00844558|O1|Outcome|Gait|No adverse events
544804|NCT00844558|E2|Reported Event|Control|Usual care for symptomatic knee OA through their usual healthcare providers and were not asked to make changes in their lifestyle. Usual care may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery and/or physical therapy.
544805|NCT00844558|E1|Reported Event|Gait|Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months
544806|NCT00844597|B7|Baseline|Total|Total of all reporting groups
544807|NCT00844597|B6|Baseline|Cohort 6 - 20.0mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544808|NCT00844597|B5|Baseline|Cohort 5 - 10.0mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544809|NCT00844597|B4|Baseline|Cohort 4 - 4.0mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544810|NCT00844597|B3|Baseline|Cohort 3 - 2.0mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544811|NCT00844597|B2|Baseline|Cohort 2 - 1.0mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544812|NCT00844597|B1|Baseline|Cohort 1 - 0.5mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544813|NCT00844597|P6|Participant Flow|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group will receive a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544814|NCT00844597|P5|Participant Flow|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group will receive a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544815|NCT00844597|P4|Participant Flow|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group will receive a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544816|NCT00844597|P3|Participant Flow|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group will receive a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544817|NCT00844597|P2|Participant Flow|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group will receive a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544818|NCT00844597|P1|Participant Flow|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
544819|NCT00844597|O6|Outcome|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
544820|NCT00844597|O5|Outcome|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
544821|NCT00844597|O4|Outcome|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
544822|NCT00844597|O3|Outcome|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
544823|NCT00844597|O2|Outcome|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
544824|NCT00844597|O1|Outcome|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
544825|NCT00844597|O1|Outcome|Open Label Treatment Arm|"Subjects will be sequentially allocated to one of 6 dose level cohorts and will receive 12 weekly IV infusions of AVI-4658 in 50 mL of normal saline solution over a 60-minute period
AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:
Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
544826|NCT00844597|O1|Outcome|Open Label Treatment Arm|"Subjects will be sequentially allocated to one of 6 dose level cohorts and will receive 12 weekly IV infusions of AVI-4658 in 50 mL of normal saline solution over a 60-minute period
AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:
Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
544827|NCT00844597|O1|Outcome|Open Label Treatment Arm|"AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:
Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
544828|NCT00844597|O1|Outcome|Open Label Treatment Arm|"AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:
Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
544829|NCT00844597|E6|Reported Event|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
544830|NCT00844597|E5|Reported Event|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
557819|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
544832|NCT00844597|E3|Reported Event|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
544833|NCT00844597|E2|Reported Event|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
544834|NCT00844597|E1|Reported Event|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
544835|NCT00844649|B3|Baseline|Total|Total of all reporting groups
544836|NCT00844649|B2|Baseline|Gemcitabine|"Gemcitabine, 1000 mg/m^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).
Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)."
544837|NCT00844649|B1|Baseline|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|"ABI-007 125 mg/m^2 administered in combination with gemcitabine 1000 mg/m^2 weekly for 3 weeks followed by one week of rest.
Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m^2 administered in combination with Gemcitabine 1000 mg/m^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest"
544838|NCT00844649|P2|Participant Flow|Gemcitabine (Gem)|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
544839|NCT00844649|P1|Participant Flow|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
544840|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
544841|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
544842|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
544843|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
544844|NCT00844649|O2|Outcome|Gemcitabine (Gem)|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
544845|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
544846|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
544847|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
544848|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
544849|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
544850|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
544851|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
544852|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
544853|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
544854|NCT00844649|E2|Reported Event|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
544855|NCT00844649|E1|Reported Event|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
544856|NCT00844714|B1|Baseline|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
544857|NCT00844714|P1|Participant Flow|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
544858|NCT00844714|O1|Outcome|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
544859|NCT00844714|E1|Reported Event|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
544860|NCT00844753|B5|Baseline|Total|Total of all reporting groups
544862|NCT00844753|B3|Baseline|Placebo + Parent Management Training|"Sugar pill administered twice daily
Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
544863|NCT00844753|B2|Baseline|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
544864|NCT00844753|B1|Baseline|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
544865|NCT00844753|P4|Participant Flow|Placebo Without Parent Management Training|Sugar pill administered twice daily.
544866|NCT00844753|P3|Participant Flow|Placebo + Parent Management Training|"Sugar pill administered twice daily
Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
544867|NCT00844753|P2|Participant Flow|Atomoxetine (ATX) Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
544868|NCT00844753|P1|Participant Flow|Atomoxetine (ATX) + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to adverse events. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
Parent Management Training (PT)-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
544869|NCT00844753|O4|Outcome|Placebo Without Parent Management Training|Sugar pill administered twice daily.
544870|NCT00844753|O3|Outcome|Placebo + Parent Management Training|"Sugar pill administered twice daily
Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
544871|NCT00844753|O2|Outcome|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
544872|NCT00844753|O1|Outcome|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
544873|NCT00844753|O4|Outcome|Placebo Without Parent Management Training|Sugar pill administered twice daily.
544874|NCT00844753|O3|Outcome|Placebo + Parent Management Training|"Sugar pill administered twice daily
Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
545008|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
544875|NCT00844753|O2|Outcome|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
544876|NCT00844753|O1|Outcome|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
544877|NCT00844753|E2|Reported Event|Placebo|Data includes the placebo alone arm and the placebo+parent therapy arm
544878|NCT00844753|E1|Reported Event|Atomoxetine|Data includes both the ATX alone arm and the ATX+ parent therapy arm
544879|NCT00844805|B3|Baseline|Total|Total of all reporting groups
544880|NCT00844805|B2|Baseline|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544881|NCT00844805|B1|Baseline|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
544882|NCT00844805|P4|Participant Flow|No Treatment|For participants who achieved partial remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
544883|NCT00844805|P3|Participant Flow|Naproxen|For participants who achieved partial remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
544884|NCT00844805|P2|Participant Flow|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544885|NCT00844805|P1|Participant Flow|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
544886|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544887|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
544888|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544889|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
544890|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
544891|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
544892|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
544893|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
544894|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
544895|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
544896|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
544897|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
544898|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
544899|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
544900|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544901|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
545009|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
544902|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544903|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
544904|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544905|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
544906|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
544907|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
544908|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
544909|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
544910|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544911|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
544912|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544913|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
544914|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544915|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
544916|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
544917|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
544918|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544919|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
544920|NCT00844805|E4|Reported Event|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
544921|NCT00844805|E3|Reported Event|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
544922|NCT00844805|E2|Reported Event|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
544923|NCT00844805|E1|Reported Event|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
544924|NCT00844831|B1|Baseline|Lubiprostone Open Label|
544925|NCT00844831|P1|Participant Flow|Lubiprostone Open Label|
544926|NCT00844831|O2|Outcome|After Open Label Treatment|Subjects receive lubiprostone and bacteria is measured after Lubiprostone: 24 mcg bid for 28 days
544927|NCT00844831|O1|Outcome|Before Open Label Lubiprostone|Bacteria is measured before Lubiprostone: 24 mcg bid for 28 days
544928|NCT00844831|O1|Outcome|Treatment With Lubiprostone|Lubiprostone: 24 mcg bid for 28 days
544929|NCT00844831|O2|Outcome|After Open Label Treatment|After 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily
544930|NCT00844831|O1|Outcome|Before Open Label Lubiprostone|Before 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily.
544931|NCT00844831|E1|Reported Event|Lubiprostone Open Label|4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily
544932|NCT00844844|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544976|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544933|NCT00844844|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544934|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544935|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544936|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544937|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544938|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544939|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544940|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544941|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544942|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544943|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544944|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544945|NCT00844844|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
544946|NCT00844857|B3|Baseline|Total|Total of all reporting groups
544947|NCT00844857|B2|Baseline|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544948|NCT00844857|B1|Baseline|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544949|NCT00844857|P2|Participant Flow|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544977|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
545094|NCT00845182|O3|Outcome|PIOGLITAZONE and EXNATIDE|Combinatiton of PIoglitazone and Exenatide led to weight gain of 2.7 kg
544950|NCT00844857|P1|Participant Flow|Olanzapine/Fluoxetine Combination|Olanzapine/fluoxetine Combination (OFC) 3 milligrams (mg) olanzapine and 25 mg fluoxetine (OFC 3/25) administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544951|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544952|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544953|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544954|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544955|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544956|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544957|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544958|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
544959|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544960|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544961|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544962|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544963|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544964|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
544965|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544966|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
544967|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544968|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544969|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544970|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544971|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544972|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544973|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544974|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544975|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
545004|NCT00844896|B2|Baseline|DEF + COPE|28 subjects in this arm of the study.
545005|NCT00844896|B1|Baseline|DEF-only|29 subjects in this arm of the study.
545095|NCT00845182|O2|Outcome|EXENATIDE|PIO therapy led to a weigh loss of 2.4 kg
544978|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544979|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544980|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
544981|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544982|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544983|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544984|NCT00844857|O1|Outcome|Olanzapine Plus Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544985|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544986|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544987|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544988|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544989|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally, once daily for 8 weeks.
544990|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544991|NCT00844857|E2|Reported Event|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
544992|NCT00844857|E1|Reported Event|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
544993|NCT00844883|B1|Baseline|Sorafenib and Drug Eluting Beads|"single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
544994|NCT00844883|P1|Participant Flow|Sorafenib and Drug Eluting Beads|"single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
544995|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
544996|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
544997|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
544998|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
544999|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
545000|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
545001|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
545002|NCT00844883|E1|Reported Event|Sorafenib and Drug Eluting Beads|"single arm
sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial
LC Bead-TACE: LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
545003|NCT00844896|B3|Baseline|Total|Total of all reporting groups
545010|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
545011|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
545012|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
545013|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
545014|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment.
545015|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
545016|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
545017|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
545018|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
545019|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
545020|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
545021|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
545022|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
545023|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
545024|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
545025|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
545026|NCT00844896|E2|Reported Event|DEF + COPE|28 subjects in this arm of the study.
545027|NCT00844896|E1|Reported Event|DEF-only|29 subjects in this arm of the study.
545028|NCT00845000|B7|Baseline|Total|Total of all reporting groups
545029|NCT00845000|B6|Baseline|Placebo→ SCH 420814 100 mg→SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545030|NCT00845000|B5|Baseline|SCH 420814 100 mg→ SCH 420814 10 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545031|NCT00845000|B4|Baseline|SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545032|NCT00845000|B3|Baseline|Placebo→SCH 420814 10 mg→SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545033|NCT00845000|B2|Baseline|SCH 420814 100 mg→Placebo→ SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545034|NCT00845000|B1|Baseline|SCH 420814 10 mg→SCH 420814 100 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545035|NCT00845000|P6|Participant Flow|Placebo→ SCH 420814 100 mg→SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545036|NCT00845000|P5|Participant Flow|SCH 420814 100 mg→ SCH 420814 10 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545096|NCT00845182|O1|Outcome|PIOGLITAZONE|PIO therapy led to a weigh gain of 5.5 kg
545097|NCT00845182|E3|Reported Event|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
545037|NCT00845000|P4|Participant Flow|SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545038|NCT00845000|P3|Participant Flow|Placebo→SCH 420814 10 mg→SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545039|NCT00845000|P2|Participant Flow|SCH 420814 100 mg→Placebo→ SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545040|NCT00845000|P1|Participant Flow|SCH 420814 10 mg→SCH 420814 100 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
545041|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
545042|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
545043|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
545044|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
545045|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
545046|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
545047|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
545048|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
545049|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
545050|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
545051|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
545052|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
545053|NCT00845000|E3|Reported Event|Placebo|Participants who received single oral dose of placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
545054|NCT00845000|E2|Reported Event|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
545055|NCT00845000|E1|Reported Event|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
545056|NCT00845065|B3|Baseline|Total|Total of all reporting groups
545057|NCT00845065|B2|Baseline|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
545058|NCT00845065|B1|Baseline|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
545059|NCT00845065|P2|Participant Flow|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
545060|NCT00845065|P1|Participant Flow|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
545061|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
545098|NCT00845182|E2|Reported Event|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
545099|NCT00845182|E1|Reported Event|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
545062|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
545063|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
545064|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
545065|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
545066|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
545067|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
545068|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
545069|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
545070|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
545071|NCT00845065|E2|Reported Event|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
545072|NCT00845065|E1|Reported Event|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
545073|NCT00845130|B3|Baseline|Total|Total of all reporting groups
545074|NCT00845130|B2|Baseline|Health Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
545075|NCT00845130|B1|Baseline|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
545076|NCT00845130|P2|Participant Flow|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
545077|NCT00845130|P1|Participant Flow|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
545078|NCT00845130|O2|Outcome|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
545079|NCT00845130|O1|Outcome|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
545080|NCT00845130|O2|Outcome|Healthy Subjects|Vitamin C levels in the living brain.
545081|NCT00845130|O1|Outcome|Diabetic Type II Subjects|Vitamin C level in the living brain
545082|NCT00845130|E2|Reported Event|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
545083|NCT00845130|E1|Reported Event|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
545084|NCT00845182|B4|Baseline|Total|Total of all reporting groups
545085|NCT00845182|B3|Baseline|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
545086|NCT00845182|B2|Baseline|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
545087|NCT00845182|B1|Baseline|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
545088|NCT00845182|P3|Participant Flow|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
545089|NCT00845182|P2|Participant Flow|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
545090|NCT00845182|P1|Participant Flow|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
545091|NCT00845182|O3|Outcome|Drug Pioglitazone and Drug Exentatide|"Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
Pioglitazone and Exenatide: Pioglitazone 30mg daily for 1 month and then 45mg daily for 5 months and Exenatide 5mcg twice daily for one month then 10mcg twice daily for 5 months"
545092|NCT00845182|O2|Outcome|Exenatide|"Exenatide: 15 subjects will be randomized to receive Exenatide
Exenatide: Exenatide 5mcg twice daily for 1 month, then 10mcg twice daily for 5 months"
545093|NCT00845182|O1|Outcome|Pioglitazone|"Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
Pioglitazone: Pioglitazone 15 mg/day for 1 month and then 45 mg/day for 5 months"
545100|NCT00845195|B3|Baseline|Total|Total of all reporting groups
545101|NCT00845195|B2|Baseline|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
545102|NCT00845195|B1|Baseline|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
545103|NCT00845195|P2|Participant Flow|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
545104|NCT00845195|P1|Participant Flow|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
545105|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
545106|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
545107|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
545108|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
545109|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
545110|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
545111|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
545112|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
545113|NCT00845195|E2|Reported Event|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
545114|NCT00845195|E1|Reported Event|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
545115|NCT00845429|B4|Baseline|Total|Total of all reporting groups
545116|NCT00845429|B3|Baseline|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
545117|NCT00845429|B2|Baseline|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
545118|NCT00845429|B1|Baseline|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
545119|NCT00845429|P3|Participant Flow|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
545120|NCT00845429|P2|Participant Flow|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
545121|NCT00845429|P1|Participant Flow|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
545122|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
545123|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
545124|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
545125|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
545126|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
545127|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
545128|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
545129|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
545130|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
545131|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
545132|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
545133|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
545134|NCT00845429|E3|Reported Event|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
545135|NCT00845429|E2|Reported Event|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
545136|NCT00845429|E1|Reported Event|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
545137|NCT00845481|B1|Baseline|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
545138|NCT00845481|P1|Participant Flow|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
545139|NCT00845481|O1|Outcome|Patients Treated With Diprosalic Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Diprosalic ointment
545140|NCT00845481|O1|Outcome|Patients Treated With Dermovat Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Dermovat ointment
545191|NCT00835536|P2|Participant Flow|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
545141|NCT00845481|O1|Outcome|Patients Treated With Daivobet® Ointment Vehicle|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® Ointment vehicle
545142|NCT00845481|O1|Outcome|Patients Treated With Elocon Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Elocon ointment
545143|NCT00845481|O1|Outcome|Patients Treated With Betnovat® Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Betnovat® ointment
545144|NCT00845481|O1|Outcome|Patients Treated With Daivobet® Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® ointment
545145|NCT00845481|E1|Reported Event|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
545146|NCT00835497|B3|Baseline|Total|Total of all reporting groups
545147|NCT00835497|B2|Baseline|Metaglip® (Reference) First|Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
545148|NCT00835497|B1|Baseline|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period
545149|NCT00835497|P2|Participant Flow|Metaglip® (Reference) First|Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
545150|NCT00835497|P1|Participant Flow|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period
545151|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
545152|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
545153|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
545154|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
545155|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
545156|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
545157|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
545158|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
545159|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
545160|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
545161|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
545162|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
545163|NCT00835510|B4|Baseline|Total|Total of all reporting groups
545164|NCT00835510|B3|Baseline|Vehicle|Butenafine vehicle applied for 7 days
545165|NCT00835510|B2|Baseline|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
545166|NCT00835510|B1|Baseline|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
545167|NCT00835510|P3|Participant Flow|Vehicle|Butenafine vehicle applied for 7 days
545168|NCT00835510|P2|Participant Flow|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
545169|NCT00835510|P1|Participant Flow|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
545170|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
545171|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
545172|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
545173|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
545174|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
545175|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
545176|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
545177|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
545178|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
545179|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
545180|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
545181|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
545182|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
545183|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
545184|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
545185|NCT00835510|E3|Reported Event|Vehicle|Butenafine vehicle applied for 7 days
545186|NCT00835510|E2|Reported Event|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
545187|NCT00835510|E1|Reported Event|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
545188|NCT00835536|B3|Baseline|Total|Total of all reporting groups
545189|NCT00835536|B2|Baseline|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
545190|NCT00835536|B1|Baseline|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
545235|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
545192|NCT00835536|P1|Participant Flow|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
545193|NCT00835536|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
545194|NCT00835536|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
545195|NCT00835536|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
545196|NCT00835536|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
545197|NCT00835549|B3|Baseline|Total|Total of all reporting groups
545198|NCT00835549|B2|Baseline|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
545199|NCT00835549|B1|Baseline|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
545200|NCT00835549|P2|Participant Flow|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
545201|NCT00835549|P1|Participant Flow|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
545202|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
545203|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
545204|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
545205|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
545206|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
545207|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
545208|NCT00835575|B3|Baseline|Total|Total of all reporting groups
545209|NCT00835575|B2|Baseline|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
545210|NCT00835575|B1|Baseline|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
545211|NCT00835575|P2|Participant Flow|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
545212|NCT00835575|P1|Participant Flow|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
545213|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
545214|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
545215|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
545216|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
545217|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
545218|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
545219|NCT00835588|B3|Baseline|Total|Total of all reporting groups
545220|NCT00835588|B2|Baseline|Protonix® (Reference) First|Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
545221|NCT00835588|B1|Baseline|Pantoprazole (Test) First|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period
545222|NCT00835588|P2|Participant Flow|Protonix® (Reference) First|Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
545223|NCT00835588|P1|Participant Flow|Pantoprazole (Test) First|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period
545224|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
545225|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
545226|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
545227|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
545228|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
545229|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
545230|NCT00835614|B3|Baseline|Total|Total of all reporting groups
545231|NCT00835614|B2|Baseline|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
545232|NCT00835614|B1|Baseline|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
545233|NCT00835614|P2|Participant Flow|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
545234|NCT00835614|P1|Participant Flow|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
545236|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
545237|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
545238|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
545239|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
545240|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
545241|NCT00835640|B3|Baseline|Total|Total of all reporting groups
545242|NCT00835640|B2|Baseline|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
545243|NCT00835640|B1|Baseline|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
545244|NCT00835640|P2|Participant Flow|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
545245|NCT00835640|P1|Participant Flow|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
545246|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
545247|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
545248|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
545249|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
545250|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
545251|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
545252|NCT00835666|B3|Baseline|Total|Total of all reporting groups
545253|NCT00835666|B2|Baseline|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
545254|NCT00835666|B1|Baseline|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
545255|NCT00835666|P2|Participant Flow|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
545256|NCT00835666|P1|Participant Flow|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
545257|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
545258|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
545259|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
545260|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
545261|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
545262|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
545263|NCT00835679|B5|Baseline|Total|Total of all reporting groups
545264|NCT00835679|B4|Baseline|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
545265|NCT00835679|B3|Baseline|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
545266|NCT00835679|B2|Baseline|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
545267|NCT00835679|B1|Baseline|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
545268|NCT00835679|P4|Participant Flow|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
545269|NCT00835679|P3|Participant Flow|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
545270|NCT00835679|P2|Participant Flow|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
545271|NCT00835679|P1|Participant Flow|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
545272|NCT00835679|O4|Outcome|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
545273|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
545274|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
545275|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
545276|NCT00835679|O4|Outcome|Cetuximab + Dasatinib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
545277|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15 1-14.
545278|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
545279|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
545280|NCT00835679|O4|Outcome|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
545281|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
545282|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
545283|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
545284|NCT00835679|O4|Outcome|Cetuximab +Dasatinib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
545285|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
545286|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
545287|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
545288|NCT00835679|E4|Reported Event|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
545289|NCT00835679|E3|Reported Event|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
545290|NCT00835679|E2|Reported Event|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
545291|NCT00835679|E1|Reported Event|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
545292|NCT00835692|B3|Baseline|Total|Total of all reporting groups
545293|NCT00835692|B2|Baseline|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
545294|NCT00835692|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
545295|NCT00835692|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
545296|NCT00835692|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
545297|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
545298|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
545299|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
545300|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
545301|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
545302|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
545303|NCT00835705|B3|Baseline|Total|Total of all reporting groups
545304|NCT00835705|B2|Baseline|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
545305|NCT00835705|B1|Baseline|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
545306|NCT00835705|P2|Participant Flow|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
545307|NCT00835705|P1|Participant Flow|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
545308|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
545309|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
545310|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
545311|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
545312|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
545313|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
545314|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
545315|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
545316|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
545317|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
545318|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
545319|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
545320|NCT00835731|B3|Baseline|Total|Total of all reporting groups
545321|NCT00835731|B2|Baseline|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually
Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.
Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
545322|NCT00835731|B1|Baseline|Misoprostol|"400mcg buccal misoprostol
misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
545323|NCT00835731|P2|Participant Flow|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually
Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.
Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
545324|NCT00835731|P1|Participant Flow|Misoprostol|"400mcg buccal misoprostol
misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
545325|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually
Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.
Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
545326|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol
misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
545327|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually
Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.
Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
545328|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol
misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
545329|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually
Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.
Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
545330|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol
misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
545331|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually
Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.
Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
545332|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol
misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
545333|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually
Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.
Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
545334|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol
misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
545335|NCT00835731|E2|Reported Event|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually
Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.
Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
545336|NCT00835731|E1|Reported Event|Misoprostol|"400mcg buccal misoprostol
misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
545337|NCT00835796|B3|Baseline|Total|Total of all reporting groups
545338|NCT00835796|B2|Baseline|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
545339|NCT00835796|B1|Baseline|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
545340|NCT00835796|P2|Participant Flow|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
545341|NCT00835796|P1|Participant Flow|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
545342|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
545343|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
545344|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
545345|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
545346|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
545347|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
545348|NCT00845663|B3|Baseline|Total|Total of all reporting groups
545349|NCT00845663|B2|Baseline|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545350|NCT00845663|B1|Baseline|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545351|NCT00845663|P2|Participant Flow|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545352|NCT00845663|P1|Participant Flow|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545353|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545354|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545355|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545356|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545357|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545358|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545359|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545360|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545361|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545362|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545363|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545364|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545365|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545366|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545367|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545368|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545369|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545370|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545371|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545372|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545373|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545374|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545375|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545376|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545377|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545378|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545379|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545380|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545381|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545382|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545383|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545384|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545385|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545386|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545387|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545388|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545389|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545390|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545391|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545392|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545393|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545394|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545395|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545396|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545397|NCT00845663|E2|Reported Event|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545398|NCT00845663|E1|Reported Event|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
545399|NCT00845676|B1|Baseline|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
545400|NCT00845676|P1|Participant Flow|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.
545401|NCT00845676|O1|Outcome|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
545402|NCT00845676|E1|Reported Event|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
545403|NCT00845702|B1|Baseline|TOF and Dotarem Enhanced MRA|Each subject will undergo a Time of Flight Magnetic Resonance Angiography followed by a Dotarem-enhanced Magnetic Resonance Angiography (with injection of Dotarem 0.2 ml/kg).
545404|NCT00845702|P1|Participant Flow|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-Of-Flight Magnetic Resonance Angiography followed by an Dotarem-enhanced Magnetic Resonance Angiography(with an injection of Dotarem 0.2 ml/kg).
545405|NCT00845702|O2|Outcome|Time Of Flight MRA|Each subject will undergo a TOF MRA
545406|NCT00845702|O1|Outcome|Dotarem MRA|Each subject will receive one injection of Dotarem 0.2 ml/kg.
545407|NCT00845702|E2|Reported Event|Time Of Flight MRA|Subjects undergo a TOF MRA
545408|NCT00845702|E1|Reported Event|Dotarem Magnetic Resonance Angiography|Each subject will receive one injection of Dotarem 0.2 ml/kg.
545409|NCT00845728|B3|Baseline|Total|Total of all reporting groups
545410|NCT00845728|B2|Baseline|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
545411|NCT00845728|B1|Baseline|Indacaterol|"Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.
delivered via the manufacturer’s proprietary inhalation device (Handihaler®)"
545412|NCT00845728|P2|Participant Flow|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
545413|NCT00845728|P1|Participant Flow|Indacaterol|"Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.
delivered via the manufacturer’s proprietary inhalation device (Handihaler®)"
545414|NCT00845728|O2|Outcome|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
545415|NCT00845728|O1|Outcome|Indacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
545416|NCT00845728|O2|Outcome|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
545417|NCT00845728|O1|Outcome|Indacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
545418|NCT00845728|E2|Reported Event|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
545419|NCT00845728|E1|Reported Event|IndIndacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
545420|NCT00845832|B4|Baseline|Total|Total of all reporting groups
545421|NCT00845832|B3|Baseline|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545422|NCT00845832|B2|Baseline|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545423|NCT00845832|B1|Baseline|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545424|NCT00845832|P3|Participant Flow|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545425|NCT00845832|P2|Participant Flow|Rituximab (0.5 Grams [g]) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545426|NCT00845832|P1|Participant Flow|Placebo + Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)|Participants received placebo intravenously (iv) on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545427|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545428|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545429|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545430|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545431|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545432|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545433|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545434|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545737|NCT00846768|E4|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545435|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545436|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545437|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545438|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545439|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545440|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545441|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545442|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545443|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545444|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545445|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545446|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545447|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545448|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545449|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545450|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545451|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545452|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545453|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545454|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545455|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545456|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545457|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545458|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545459|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545460|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545461|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545462|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545463|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545464|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545465|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545466|NCT00845832|E3|Reported Event|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545467|NCT00845832|E2|Reported Event|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545468|NCT00845832|E1|Reported Event|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
545469|NCT00845975|B3|Baseline|Total|Total of all reporting groups
545470|NCT00845975|B2|Baseline|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.
Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
545486|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
545738|NCT00846768|E3|Reported Event|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545471|NCT00845975|B1|Baseline|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.
Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.
Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.
Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
545472|NCT00845975|P2|Participant Flow|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.
Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
545473|NCT00845975|P1|Participant Flow|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 milliwatts (mW) laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.
Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.
Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.
Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
545474|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.
Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
545475|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.
Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.
Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.
Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
545476|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.
Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
545477|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.
Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.
Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.
Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
545478|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.
Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
545479|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.
Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.
Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.
Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
545480|NCT00845975|E2|Reported Event|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.
Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
545481|NCT00845975|E1|Reported Event|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.
Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.
Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.
Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
545482|NCT00846027|B1|Baseline|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
545483|NCT00846027|P1|Participant Flow|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
545484|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
545485|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
545739|NCT00846768|E2|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545487|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
545488|NCT00846027|E1|Reported Event|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
545489|NCT00846066|B3|Baseline|Total|Total of all reporting groups
545490|NCT00846066|B2|Baseline|WBT+HOT|Web Based Training plus Hands on Training
545491|NCT00846066|B1|Baseline|WBT Only|Control Group Web Based Training only
545492|NCT00846066|P2|Participant Flow|WBT Plus Hands on Training (HOT)|This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
545493|NCT00846066|P1|Participant Flow|Web Based Training Only (WBT)|This group received only the web based training prior to randomization(control group)
545494|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
545495|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
545496|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
545497|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
545498|NCT00846066|O2|Outcome|WBT + HOT|Web Based Training plus Hands on Training
545499|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
545500|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
545501|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
545502|NCT00846066|E2|Reported Event|WBT Plus Hands on Training (HOT)|This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
545503|NCT00846066|E1|Reported Event|Web Based Training Only (WBT)|This group received only the web based training prior to randomization(control group)
545504|NCT00846287|B3|Baseline|Total|Total of all reporting groups
545505|NCT00846287|B2|Baseline|Drug Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
545506|NCT00846287|B1|Baseline|Saline|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
545507|NCT00846287|P2|Participant Flow|Active Comparator: Drug Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
545508|NCT00846287|P1|Participant Flow|Active Comparator: Saline|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
545509|NCT00846287|O2|Outcome|Brovana Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
545510|NCT00846287|O1|Outcome|Placebo Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag
545574|NCT00846391|B3|Baseline|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
557820|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
545511|NCT00846287|O2|Outcome|Brovana Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
545512|NCT00846287|O1|Outcome|Placebo Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag
545513|NCT00846287|E2|Reported Event|Drug Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
545514|NCT00846287|E1|Reported Event|Saline|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
545515|NCT00846365|B4|Baseline|Total|Total of all reporting groups
545516|NCT00846365|B3|Baseline|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545517|NCT00846365|B2|Baseline|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545518|NCT00846365|B1|Baseline|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545519|NCT00846365|P3|Participant Flow|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545520|NCT00846365|P2|Participant Flow|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545521|NCT00846365|P1|Participant Flow|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545522|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545523|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545524|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545729|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
557821|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
545525|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545526|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545527|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545528|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545529|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545530|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545531|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545532|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545533|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545534|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545535|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545536|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545537|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545538|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545539|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545540|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545730|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545541|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545542|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545543|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545544|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545545|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545546|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545547|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545548|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545549|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545550|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545551|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545552|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545553|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545554|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545555|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545556|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545731|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545557|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545558|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545559|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545560|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545561|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545562|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545563|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545564|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545565|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545566|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545567|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545568|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545569|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545570|NCT00846365|E3|Reported Event|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545571|NCT00846365|E2|Reported Event|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545572|NCT00846365|E1|Reported Event|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
545573|NCT00846391|B4|Baseline|Total|Total of all reporting groups
545575|NCT00846391|B2|Baseline|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
545576|NCT00846391|B1|Baseline|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
545577|NCT00846391|P3|Participant Flow|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
545578|NCT00846391|P2|Participant Flow|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
545579|NCT00846391|P1|Participant Flow|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
545580|NCT00846391|O3|Outcome|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
545581|NCT00846391|O2|Outcome|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
545582|NCT00846391|O1|Outcome|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
545583|NCT00846391|E3|Reported Event|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
545584|NCT00846391|E2|Reported Event|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
545585|NCT00846391|E1|Reported Event|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
545586|NCT00846495|B3|Baseline|Total|Total of all reporting groups
545587|NCT00846495|B2|Baseline|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
545588|NCT00846495|B1|Baseline|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
545589|NCT00846495|P2|Participant Flow|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
545590|NCT00846495|P1|Participant Flow|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
545591|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
545592|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
545593|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
545594|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
545595|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
545596|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
545597|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
545598|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
545732|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545733|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545599|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
545600|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
545601|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
545602|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
545603|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
545604|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
545605|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
545606|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
545607|NCT00846495|E2|Reported Event|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
545608|NCT00846495|E1|Reported Event|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
545609|NCT00846521|B1|Baseline|Acarbose Administration|"Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).
Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner."
545610|NCT00846521|P1|Participant Flow|Acarbose Administration|"Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).
Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner."
545611|NCT00846521|O1|Outcome|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study
545612|NCT00846521|O1|Outcome|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study
545613|NCT00846521|E1|Reported Event|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
545614|NCT00846547|B1|Baseline|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
545615|NCT00846547|P1|Participant Flow|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
545616|NCT00846547|O1|Outcome|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
545617|NCT00846547|E1|Reported Event|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
545618|NCT00846573|B4|Baseline|Total|Total of all reporting groups
545619|NCT00846573|B3|Baseline|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
545620|NCT00846573|B2|Baseline|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
545621|NCT00846573|B1|Baseline|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
545622|NCT00846573|P4|Participant Flow|Healthy|"This population is made up of subjects who are considered clinically healthy. This means that there are no records of any chronic disorders or pulmonary history.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
545623|NCT00846573|P3|Participant Flow|Cystic Fibrosis|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
545624|NCT00846573|P2|Participant Flow|Asthma|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
545625|NCT00846573|P1|Participant Flow|COPD|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
545626|NCT00846573|O3|Outcome|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
545627|NCT00846573|O2|Outcome|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
545628|NCT00846573|O1|Outcome|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
545629|NCT00846573|E3|Reported Event|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
545630|NCT00846573|E2|Reported Event|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
545631|NCT00846573|E1|Reported Event|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
545632|NCT00846586|B3|Baseline|Total|Total of all reporting groups
545633|NCT00846586|B2|Baseline|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545634|NCT00846586|B1|Baseline|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545635|NCT00846586|P2|Participant Flow|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545734|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545636|NCT00846586|P1|Participant Flow|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545637|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545638|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545639|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545640|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545641|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545642|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545643|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545644|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545645|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545646|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545647|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545648|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
557822|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
545649|NCT00846586|E2|Reported Event|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545650|NCT00846586|E1|Reported Event|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
545651|NCT00846651|B3|Baseline|Total|Total of all reporting groups
545652|NCT00846651|B2|Baseline|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545653|NCT00846651|B1|Baseline|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545654|NCT00846651|P2|Participant Flow|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545655|NCT00846651|P1|Participant Flow|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545656|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545657|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545658|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545659|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545660|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545661|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545662|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545663|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545664|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545665|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545666|NCT00846651|E2|Reported Event|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545667|NCT00846651|E1|Reported Event|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
545668|NCT00846768|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, active-controlled, 4 way crossover trial. 47 patients were assigned randomly to one of 4 treatment sequences in which they received each of the 4 treatments. The duration of each treatment period was 3 weeks with no washout period between treatments.
545669|NCT00846768|P4|Participant Flow|Olo 10mcg qd / Olo 5mcg Bid / Olo 2mcg Bid / Olo 5mcg qd|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg bid in the second period, Olodaterol 2 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.
545670|NCT00846768|P3|Participant Flow|Olo 5mcg Bid / Olo 5mcg qd / Olo 10mcg qd / Olo 2mcg Bid|Patients were administered Olodaterol 5 mcg bid in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 2 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
545671|NCT00846768|P2|Participant Flow|Olo 5mcg qd / Olo 2mcg Bid / Olo 5mcg Bid / Olo 10mcg qd|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg bid in the second period, Olodaterol 5 mcg bid in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.
545672|NCT00846768|P1|Participant Flow|Olo 2mcg Bid / Olo 10mcg qd / Olo 5mcg qd / Olo 5mcg Bid|Patients were administered Olodaterol 2 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and Olodaterol 5 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
545673|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545674|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545675|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545676|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545677|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545678|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545679|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545680|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545681|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545682|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545683|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545684|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545685|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545686|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545687|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545688|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545689|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545690|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545691|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545692|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545693|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545694|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545695|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545696|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545697|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545698|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545699|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545700|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545701|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545702|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545703|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545704|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545705|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545706|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545707|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545708|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545709|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545710|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545711|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545712|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545713|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545714|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545715|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545716|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545717|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545718|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545719|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545720|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545721|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545722|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545723|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545724|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545725|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
545726|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
545727|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
545728|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
557823|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
545740|NCT00846768|E1|Reported Event|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
545741|NCT00846807|B1|Baseline|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
545742|NCT00846807|P1|Participant Flow|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
545743|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
545744|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
545745|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
545746|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
545747|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
545748|NCT00846807|E1|Reported Event|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
545749|NCT00846846|B1|Baseline|Endeavor® Zotarolimus Eluting Coronary Stent System|Endeavor® Zotarolimus Eluting Coronary Stent Implantation in a patient population requiring stent implantation.
545750|NCT00846846|P1|Participant Flow|Endeavor® Zotarolimus Eluting Coronary Stent System|"Endeavor® Zotarolimus Eluting Coronary Stent System >
> Endeavor® Zotarolimus Eluting Coronary Stent System: Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation"
545751|NCT00846846|O1|Outcome|Endeavor® Zotarolimus Eluting Coronary Stent System|Intention to treat analyis has been used.
545752|NCT00846846|O1|Outcome|Endeavor® Zotarolimus Eluting Coronary Stent System|Intention to treat analyis has been used.
545753|NCT00846846|E1|Reported Event|Endeavor|Medtronic Endeavor
545754|NCT00846885|B3|Baseline|Total|Total of all reporting groups
545755|NCT00846885|B2|Baseline|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
545756|NCT00846885|B1|Baseline|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
545757|NCT00846885|P2|Participant Flow|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
545758|NCT00846885|P1|Participant Flow|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
545759|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
545760|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
545761|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
545762|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
545763|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
545764|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
545765|NCT00847002|B3|Baseline|Total|Total of all reporting groups
545766|NCT00847002|B2|Baseline|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
545767|NCT00847002|B1|Baseline|Standard of Care Wound Treatment|Standard Wound Care using compression
545768|NCT00847002|P2|Participant Flow|Flexitouch System|Flexitouch system with Standard Wound Care using compression
545769|NCT00847002|P1|Participant Flow|Standard of Care|Standard Wound Care using compression
545770|NCT00847002|O2|Outcome|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
545771|NCT00847002|O1|Outcome|Standard of Care Wound Treatment|Standard Wound Care using compression
545772|NCT00847002|O2|Outcome|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
545773|NCT00847002|O1|Outcome|Standard of Care Wound Treatment|Standard Wound Care using compression
545774|NCT00847002|E2|Reported Event|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
545775|NCT00847002|E1|Reported Event|Standard of Care Wound Treatment|Standard Wound Care using compression
545776|NCT00847015|B1|Baseline|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
545777|NCT00847015|P1|Participant Flow|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
545868|NCT00847197|E1|Reported Event|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
545778|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
545779|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
545780|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
545781|NCT00847015|E1|Reported Event|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
545782|NCT00847132|B3|Baseline|Total|Total of all reporting groups
545783|NCT00847132|B2|Baseline|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.
Usual Care Treatment: treatment as usual, providers are notified of diagnoses"
545784|NCT00847132|B1|Baseline|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations
Collaborative Care Treatment: depression education, treatment recommendations, coordination of care"
545785|NCT00847132|P2|Participant Flow|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.
Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
545786|NCT00847132|P1|Participant Flow|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations
Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
545787|NCT00847132|O2|Outcome|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.
Usual Care Treatment: treatment as usual, providers are notified of diagnoses"
545788|NCT00847132|O1|Outcome|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations
Collaborative Care Treatment: depression education, treatment recommendations, coordination of care"
545789|NCT00847132|O2|Outcome|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.
Usual Care Treatment: treatment as usual, providers are notified of diagnoses"
545790|NCT00847132|O1|Outcome|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations
Collaborative Care Treatment: depression education, treatment recommendations, coordination of care"
545791|NCT00847132|E2|Reported Event|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.
Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
545792|NCT00847132|E1|Reported Event|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations
Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
545793|NCT00847145|B9|Baseline|Total|Total of all reporting groups
545794|NCT00847145|B8|Baseline|12B13M_C (4b)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
545795|NCT00847145|B7|Baseline|12B12M_C (4a)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
545796|NCT00847145|B6|Baseline|12B13M (3b)|Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
545797|NCT00847145|B5|Baseline|12B12M (3a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
545869|NCT00847210|B3|Baseline|Total|Total of all reporting groups
545798|NCT00847145|B4|Baseline|12M12B14B (2b)|Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
545799|NCT00847145|B3|Baseline|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
545800|NCT00847145|B2|Baseline|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
545801|NCT00847145|B1|Baseline|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
545802|NCT00847145|P8|Participant Flow|12B13M_C (4b)|Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
545803|NCT00847145|P7|Participant Flow|12B12M_C (4a)|Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
545804|NCT00847145|P6|Participant Flow|12B13M (3b)|Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
545805|NCT00847145|P5|Participant Flow|12B12M (3a)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
545806|NCT00847145|P4|Participant Flow|12M12B14B (2b)|Previously in the parent study (NCT00657709) subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
545807|NCT00847145|P3|Participant Flow|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
545808|NCT00847145|P2|Participant Flow|12B13M (1b)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
545809|NCT00847145|P1|Participant Flow|12B12M (1a)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
545810|NCT00847145|O4|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
545811|NCT00847145|O3|Outcome|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
545812|NCT00847145|O2|Outcome|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
545813|NCT00847145|O1|Outcome|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
545814|NCT00847145|O4|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
545815|NCT00847145|O3|Outcome|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
545816|NCT00847145|O2|Outcome|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
545817|NCT00847145|O1|Outcome|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
545818|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
546463|NCT00847886|B2|Baseline|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
545819|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
545820|NCT00847145|O4|Outcome|12B13M|Combination of Groups 12B13M (1b) and 12B13M (3b).
545821|NCT00847145|O3|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
545822|NCT00847145|O2|Outcome|12B13M_C (4b)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
545823|NCT00847145|O1|Outcome|12B12M_C (4a)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
545824|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
545825|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
545826|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
545827|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
545828|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
545829|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
545830|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
545831|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
545832|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
545833|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
545834|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine was given concomitantly at 12 months of age in the present study
545835|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
545836|NCT00847145|O4|Outcome|Routine246|Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age [12M13B15B (2a)]; 12 and 14 months [12M12B14B (2b)] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
545837|NCT00847145|O3|Outcome|Men246|Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
545838|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
545839|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjets received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
545840|NCT00847145|O4|Outcome|Routine246|Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age [12M13B15B (2a)]; 12 and 14 months [12M12B14B (2b)] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
545841|NCT00847145|O3|Outcome|Men246|Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
557824|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
545842|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
545843|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjets received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
545844|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
545845|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
545846|NCT00847145|O2|Outcome|12M13B15B (2a)|Previously in the parent study subjects had received only routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age in the present study.
545847|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine.
545848|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
545849|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
545850|NCT00847145|E6|Reported Event|12B13M_C (4b)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
4b - rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
545851|NCT00847145|E5|Reported Event|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
545852|NCT00847145|E4|Reported Event|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
545853|NCT00847145|E3|Reported Event|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
545854|NCT00847145|E2|Reported Event|12B13M|"Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
This group is a combination of Groups 12B13M (1b) and 12B13M (3b) for safety data analysis purposes."
545855|NCT00847145|E1|Reported Event|12B12M|"Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
This group is a combination of Groups 12B12M (1a) and 12B12M (3a) for safety data analysis purposes."
545856|NCT00847197|B3|Baseline|Total|Total of all reporting groups
545857|NCT00847197|B2|Baseline|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
545858|NCT00847197|B1|Baseline|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
545859|NCT00847197|P2|Participant Flow|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
545860|NCT00847197|P1|Participant Flow|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
545861|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
545862|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
545863|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
545864|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
545865|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
545866|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
545867|NCT00847197|E2|Reported Event|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
546464|NCT00847886|B1|Baseline|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
545870|NCT00847210|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
545871|NCT00847210|B1|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
545872|NCT00847210|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
545873|NCT00847210|P1|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
545874|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
545875|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
545876|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
545877|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
545878|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
545879|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
545880|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
545881|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
545882|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
545883|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
545884|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
545885|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
545886|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
545887|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
545888|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
545889|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
545890|NCT00847210|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
545891|NCT00847210|E1|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
545892|NCT00847288|B3|Baseline|Total|Total of all reporting groups
545893|NCT00847288|B2|Baseline|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
545894|NCT00847288|B1|Baseline|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
545895|NCT00847288|P2|Participant Flow|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
545896|NCT00847288|P1|Participant Flow|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
545897|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
545898|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
545899|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
545900|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
545901|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
545902|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
545903|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
545904|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
545905|NCT00847288|E2|Reported Event|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
545906|NCT00847288|E1|Reported Event|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
545907|NCT00847301|B1|Baseline|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
545908|NCT00847301|P1|Participant Flow|Overall Study Design|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily
545909|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
545910|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
545911|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
545912|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
545913|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
545914|NCT00847301|E1|Reported Event|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
545915|NCT00847405|B3|Baseline|Total|Total of all reporting groups
545916|NCT00847405|B2|Baseline|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
545917|NCT00847405|B1|Baseline|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
545918|NCT00847405|P2|Participant Flow|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
545919|NCT00847405|P1|Participant Flow|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
545920|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
545921|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
545922|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
545923|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
545924|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
545925|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
545926|NCT00847509|B1|Baseline|[F-18]FLT Scan|
545927|NCT00847509|P1|Participant Flow|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
545928|NCT00847509|O1|Outcome|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
545929|NCT00847509|E1|Reported Event|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
545930|NCT00847535|B1|Baseline|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
545931|NCT00847535|P3|Participant Flow|Part II: Transurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
545932|NCT00847535|P2|Participant Flow|Part I: Periurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
545933|NCT00847535|P1|Participant Flow|Part I: Transurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
545934|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
545935|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
545936|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
545937|NCT00847535|O1|Outcome|Patients With Biopsy|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
545938|NCT00847535|O1|Outcome|Patients With Biopsy|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
545939|NCT00847535|E1|Reported Event|Patients|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women
545940|NCT00847561|B3|Baseline|Total|Total of all reporting groups
545941|NCT00847561|B2|Baseline|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.
Information Monitoring: Packet providing information on strategies for coping with anxiety"
545942|NCT00847561|B1|Baseline|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.
Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
545943|NCT00847561|P2|Participant Flow|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.
Information Monitoring: Packet providing information on strategies for coping with anxiety"
545944|NCT00847561|P1|Participant Flow|Family-based CBT|"Family-based Cognitive Behavioral Therapy (CBT). Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.
Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
546231|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
545945|NCT00847561|O2|Outcome|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.
Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
545946|NCT00847561|O1|Outcome|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.
Information Monitoring: Packet providing information on strategies for coping with anxiety"
545947|NCT00847561|E2|Reported Event|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.
Information Monitoring: Packet providing information on strategies for coping with anxiety"
545948|NCT00847561|E1|Reported Event|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.
Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
545949|NCT00847587|B3|Baseline|Total|Total of all reporting groups
545950|NCT00847587|B2|Baseline|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
545951|NCT00847587|B1|Baseline|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
545952|NCT00847587|P2|Participant Flow|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
545953|NCT00847587|P1|Participant Flow|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
545954|NCT00847587|O2|Outcome|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
545955|NCT00847587|O1|Outcome|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
545956|NCT00847587|O2|Outcome|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
545957|NCT00847587|O1|Outcome|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
545958|NCT00847587|E2|Reported Event|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
545959|NCT00847587|E1|Reported Event|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
545960|NCT00847613|B5|Baseline|Total|Total of all reporting groups
545961|NCT00847613|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
545962|NCT00847613|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
545963|NCT00847613|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
545964|NCT00847613|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
545965|NCT00847613|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
545966|NCT00847613|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
545967|NCT00847613|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
545968|NCT00847613|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
545969|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
545970|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
545971|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
545972|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546232|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
545973|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
545974|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
545975|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
545976|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
545977|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
545978|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
545979|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
545980|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
545981|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
545982|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
545983|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
545984|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
545985|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
545986|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
545987|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
545988|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
545989|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
545990|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
545991|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
545992|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
545993|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
545994|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
545995|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
545996|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
545997|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
545998|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546233|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
545999|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546000|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546001|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546002|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546003|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546004|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546005|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546006|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546007|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546008|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546009|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546010|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546011|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546012|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546013|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546014|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546015|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546016|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546017|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546018|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546019|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546020|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546021|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546022|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546023|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546024|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546025|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546026|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546027|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546028|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546029|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546030|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546031|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546032|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546033|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546034|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546035|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546036|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546037|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546038|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546039|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546040|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546041|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546042|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546043|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546044|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546045|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546046|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546047|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546048|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546049|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546050|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546051|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546052|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546234|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546053|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546054|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546055|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546056|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546057|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546058|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546059|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546060|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546061|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546062|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546063|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546064|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546065|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546066|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546067|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546068|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546069|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546070|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546071|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546072|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546073|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546074|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546075|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546076|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546077|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546078|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546079|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546080|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546081|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546082|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546083|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546084|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546085|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546086|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546087|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546088|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546089|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546090|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546091|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546092|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546093|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546094|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546095|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546096|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546097|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546098|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546099|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546100|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546101|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546102|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546103|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546104|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546105|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546106|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546107|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546108|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546109|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546110|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546111|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546112|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546113|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546114|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546115|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546116|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546117|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546118|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546119|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546120|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546121|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546122|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546123|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546124|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546125|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546126|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546127|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546128|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546129|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546130|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546131|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546132|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546133|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546134|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546135|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546136|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546137|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546138|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546139|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546140|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546141|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546142|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546143|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546144|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546145|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546146|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546147|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546148|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546149|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546150|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546151|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546152|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546153|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546154|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546155|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546156|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546157|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546158|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546159|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546160|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546161|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546162|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546163|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546164|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546165|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546166|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546167|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546168|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546169|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546170|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546171|NCT00847613|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546172|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546173|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546174|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546175|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546176|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546177|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546178|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
546179|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
546180|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546181|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546182|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546183|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546184|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546185|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546186|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546187|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546188|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546189|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546190|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546191|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546192|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546193|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546235|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546194|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
546195|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
546196|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
546197|NCT00847613|E8|Reported Event|CP-690,550 10 mg (Post Month 6)|Participants who received either CP-690,550 10 mg or matching placebo up to Month 6, received CP-690,550 10 mg tablet orally twice daily from Month 6 to 24.
546198|NCT00847613|E7|Reported Event|CP-690,550 5 mg (Post Month 6)|Participants who received either CP-690,550 5 mg or matching placebo up to Month 6, received CP-690,550 5 mg tablet orally twice daily from Month 6 to 24.
546199|NCT00847613|E6|Reported Event|Placebo (Month 3 to 6)|Participants received placebo matched to CP-690,550 tablet orally twice daily from Month 3 to 6.
546200|NCT00847613|E5|Reported Event|CP-690,550 10 mg (Month 3 to 6)|Participants who received either CP-690,550 10 mg or matching placebo up to Month 3, received CP-690,550 10 mg tablet orally twice daily from Month 3 to 6.
546201|NCT00847613|E4|Reported Event|CP-690,550 5 mg (Month 3 to 6)|Participants who received either CP-690,550 5 mg or matching placebo up to Month 3, received CP-690,550 5 mg tablet orally twice daily from Month 3 to 6.
546202|NCT00847613|E3|Reported Event|Placebo (Up to Month 3)|Participants received placebo matched to CP-690,550 tablet orally twice daily up to Month 3.
546203|NCT00847613|E2|Reported Event|CP-690,550 10 mg (Up to Month 3)|Participants received CP-690,550 10 mg tablet orally twice daily up to Month 3.
546204|NCT00847613|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|Participants received CP-690,550 5 mg tablet orally twice daily up to Month 3.
546205|NCT00847626|B12|Baseline|Total|Total of all reporting groups
546206|NCT00847626|B11|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546207|NCT00847626|B10|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546208|NCT00847626|B9|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546209|NCT00847626|B8|Baseline|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546210|NCT00847626|B7|Baseline|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546211|NCT00847626|B6|Baseline|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546212|NCT00847626|B5|Baseline|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546213|NCT00847626|B4|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546214|NCT00847626|B3|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546215|NCT00847626|B2|Baseline|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546216|NCT00847626|B1|Baseline|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546217|NCT00847626|P11|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546218|NCT00847626|P10|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546219|NCT00847626|P9|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546220|NCT00847626|P8|Participant Flow|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546221|NCT00847626|P7|Participant Flow|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546222|NCT00847626|P6|Participant Flow|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546223|NCT00847626|P5|Participant Flow|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546224|NCT00847626|P4|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546225|NCT00847626|P3|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546226|NCT00847626|P2|Participant Flow|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546227|NCT00847626|P1|Participant Flow|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546228|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546229|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546230|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546465|NCT00847886|P2|Participant Flow|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546236|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546237|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546238|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546239|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546240|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546241|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546242|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546243|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546244|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546245|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546246|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546247|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546248|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546249|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546250|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546251|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546252|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546253|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546254|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546255|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546256|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546257|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546258|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546259|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546260|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546261|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546262|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546263|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546264|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546265|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546266|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546267|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546268|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546269|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546270|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546271|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546272|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546273|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546469|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546274|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546275|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546276|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546277|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546278|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546279|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546280|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546281|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546282|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546283|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546284|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546285|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546286|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546287|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546288|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546289|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546290|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546291|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546292|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546293|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546294|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546295|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546296|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546297|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546298|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546299|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546300|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546301|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546302|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546303|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546304|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546305|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546306|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546307|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546308|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546309|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546310|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546311|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546466|NCT00847886|P1|Participant Flow|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546312|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546313|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546314|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546315|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546316|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546317|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546318|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546319|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546320|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546321|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546322|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546323|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546324|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546325|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546326|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546327|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546328|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546329|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546330|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546331|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546332|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546333|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546334|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546335|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546336|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546337|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546338|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546339|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546340|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546341|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546342|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546343|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546344|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546345|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546346|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546347|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546348|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546349|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546467|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546350|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546351|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546352|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546353|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546354|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546355|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546356|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546357|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546358|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546359|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546360|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546361|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546362|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546363|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546364|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546365|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546366|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546367|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546368|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546369|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546370|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546371|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546372|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546373|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546374|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546375|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546376|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546377|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546378|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546379|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546380|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546381|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546382|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546383|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546384|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546385|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546386|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546387|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546468|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546388|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546389|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546390|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546391|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546392|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546393|NCT00847626|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546394|NCT00847626|O2|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546395|NCT00847626|O1|Outcome|Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
OR
Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks."
546396|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546397|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546398|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546399|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546400|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546401|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546402|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546403|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546404|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546405|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546406|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546407|NCT00847626|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546408|NCT00847626|O2|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546409|NCT00847626|O1|Outcome|Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
OR
Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks."
546410|NCT00847626|E11|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546411|NCT00847626|E10|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546412|NCT00847626|E9|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
546413|NCT00847626|E8|Reported Event|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546414|NCT00847626|E7|Reported Event|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546415|NCT00847626|E6|Reported Event|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546416|NCT00847626|E5|Reported Event|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546417|NCT00847626|E4|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546418|NCT00847626|E3|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546419|NCT00847626|E2|Reported Event|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
546420|NCT00847626|E1|Reported Event|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
546421|NCT00847665|B3|Baseline|Total|Total of all reporting groups
546422|NCT00847665|B2|Baseline|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546423|NCT00847665|B1|Baseline|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546461|NCT00847808|E1|Reported Event|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546424|NCT00847665|P2|Participant Flow|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546425|NCT00847665|P1|Participant Flow|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546426|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546427|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546428|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546429|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546430|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546431|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546432|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546433|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546434|NCT00847665|E2|Reported Event|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546435|NCT00847665|E1|Reported Event|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
546436|NCT00847704|B1|Baseline|Test Group|"Device: Assisted movement and enhanced sensation
Assisted movement and enhanced sensation: Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.
Assisted movement and enhanced sensation: Thirty treatment sessions on the AMES device, each session 30 minutes of cyclic rotation of the ankle with tendon vibration. Testing before, during, and after treatments to evaluate response to treatments."
546437|NCT00847704|P1|Participant Flow|Test Group|Device: Assisted movement and enhanced sensation
546438|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
546439|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
546440|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
546441|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
546442|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
546443|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
546444|NCT00847704|E1|Reported Event|Test Treatment Group|Device: Subjects receiving AMES treatments.
546445|NCT00847808|B1|Baseline|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546446|NCT00847808|P1|Participant Flow|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546447|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546448|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546449|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546450|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546451|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546452|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546453|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546454|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546455|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546456|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546457|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546458|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546459|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546460|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
546470|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546471|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546472|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546473|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546474|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546475|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546476|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546477|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546478|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546479|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546480|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546481|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546482|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546483|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546484|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546485|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546486|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546487|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546488|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546489|NCT00847886|E2|Reported Event|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
546490|NCT00847886|E1|Reported Event|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
546491|NCT00847912|B3|Baseline|Total|Total of all reporting groups
546492|NCT00847912|B2|Baseline|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses
Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
546493|NCT00847912|B1|Baseline|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses
5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
546494|NCT00847912|P2|Participant Flow|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses
Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
546495|NCT00847912|P1|Participant Flow|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses
5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
546496|NCT00847912|O2|Outcome|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses
Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
546519|NCT00848042|O2|Outcome|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
546520|NCT00848042|O1|Outcome|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
546521|NCT00848042|E3|Reported Event|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
546923|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
546497|NCT00847912|O1|Outcome|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses
5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
546498|NCT00847912|O2|Outcome|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses
Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
546499|NCT00847912|O1|Outcome|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-fluorouracil (5-FU) cream applied to face and ears twice daily for maximum of 56 doses
5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
546500|NCT00847912|E2|Reported Event|Arm 2: Placebo|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses
Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
546501|NCT00847912|E1|Reported Event|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses
5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
546502|NCT00848016|B1|Baseline|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
546503|NCT00848016|P1|Participant Flow|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
546504|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
546505|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
546506|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
546507|NCT00848016|E1|Reported Event|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
546508|NCT00848042|B4|Baseline|Total|Total of all reporting groups
546509|NCT00848042|B3|Baseline|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
546510|NCT00848042|B2|Baseline|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
546511|NCT00848042|B1|Baseline|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
546512|NCT00848042|P3|Participant Flow|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
546513|NCT00848042|P2|Participant Flow|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
546514|NCT00848042|P1|Participant Flow|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
546515|NCT00848042|O3|Outcome|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
546516|NCT00848042|O2|Outcome|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
546517|NCT00848042|O1|Outcome|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
546518|NCT00848042|O3|Outcome|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
546522|NCT00848042|E2|Reported Event|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
546523|NCT00848042|E1|Reported Event|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
546524|NCT00848081|B3|Baseline|Total|Total of all reporting groups
546525|NCT00848081|B2|Baseline|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
546526|NCT00848081|B1|Baseline|Placebo|Placebo by mouth once daily for 12 weeks
546527|NCT00848081|P2|Participant Flow|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
546528|NCT00848081|P1|Participant Flow|Placebo|Placebo by mouth once daily for 12 weeks
546529|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
546530|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
546531|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
546532|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
546533|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
546534|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
546535|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
546536|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
546537|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
546538|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
546539|NCT00848081|E2|Reported Event|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
546540|NCT00848081|E1|Reported Event|Placebo|Placebo by mouth once daily for 12 weeks
546541|NCT00848107|B1|Baseline|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
546542|NCT00848107|P1|Participant Flow|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
546543|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
546544|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
546545|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
546546|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
546547|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
546548|NCT00848107|E1|Reported Event|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
546549|NCT00848120|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
546550|NCT00848120|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 24 weeks.
546551|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
546552|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
546553|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
546554|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
546555|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
546556|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
546557|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
546558|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
546559|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
546560|NCT00848120|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
546561|NCT00848172|B3|Baseline|Total|Total of all reporting groups
546562|NCT00848172|B2|Baseline|Sequence Placebo / OA|First day: placebo Second day: octanoic acid
546563|NCT00848172|B1|Baseline|Sequence OA / Placebo|First day: octanoic acid Second day: placebo
546564|NCT00848172|P2|Participant Flow|Sequence Placebo / OA|During the 3-day inpatient Visit 2 (Drug Administration), after the admissions day (day 1 of Visit 2) patients randomized to Sequence OA / Placebo received Placebo on the second day of Visit 2, and a single oral dose of 4 mg/kg OA on the third day of Visit 2. Patients were discharged at the end of the third day of Visit 2, which ended this study visit.
546565|NCT00848172|P1|Participant Flow|Sequence OA / Placebo|During the 3-day inpatient Visit 2 (Drug Administration), after the admissions day (day 1 of Visit 2) patients randomized to Sequence OA / Placebo received a single oral dose of 4 mg/kg OA on the second day of Visit 2, and matching Placebo on the third day of Visit 2. Patients were discharged at the end of the third day of Visit 2, which ended this study visit.
546566|NCT00848172|O1|Outcome|Octanoic Acid AUC|
546567|NCT00848172|O1|Outcome|Octanoic Acid Tmax|
546568|NCT00848172|O2|Outcome|Placebo|
546569|NCT00848172|O1|Outcome|Octanoic Acid|
546570|NCT00848172|O2|Outcome|Placebo|
546571|NCT00848172|O1|Outcome|Octanoic Acid|
546622|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
546572|NCT00848172|E3|Reported Event|Non-drug Related|AE was considered to be non-drug related, if no temporal connection was present between AE occurrence and drug administration (e.g. if AE occurred during the study, but prior to drug-administration), or an AE was clearly related to a study procedure (e.g. PICC line) rather than the study drug.
546573|NCT00848172|E2|Reported Event|Placebo|
546574|NCT00848172|E1|Reported Event|Octanoic Acid|
546575|NCT00848185|B4|Baseline|Total|Total of all reporting groups
546576|NCT00848185|B3|Baseline|Long Protocol-hCG|Long Protocol and hCG to trigger oocyte maturation
546577|NCT00848185|B2|Baseline|Antagonist-aGnRH to Trigger|Protocol with antagonist and 0.2 mg triptorelin to trigger oocyte maturation
546578|NCT00848185|B1|Baseline|Antagonist-hCG to Trigger|Protocol with antagonist and hCG to trigger oocyte maturation
546579|NCT00848185|P3|Participant Flow|Long Protocol hCG|Long Protocol with hCG to trigger oocyte maturation
546580|NCT00848185|P2|Participant Flow|Antagonist Trigger With hCG|Protocol with antagonist and hCG to trigger oocyte maturation
546581|NCT00848185|P1|Participant Flow|Antagonist Trigger With aGnRH|Protocol with antagonist and 0,2 mg triptorelin to trigger oocyte maturation
546582|NCT00848185|O3|Outcome|Long Protocol- hCG|Levels of VEGF in folicular fluid of patients with long protocol anf hCG for triggering
546583|NCT00848185|O2|Outcome|Antagonist-aGnRH Levels of VEGF|Levels of VEGF in folicular fluid of patients with antagonist protocol and aGnRH for triggering
546584|NCT00848185|O1|Outcome|Antagonist-hCG Levels of VEGF|Levels of VEGF in folicular fluid of patients with antagonist protocol anf hCG for triggering
546585|NCT00848185|E3|Reported Event|Long Protocol - hCG Trigger|Long protocol and hCG trigger as control
546586|NCT00848185|E2|Reported Event|GnRH Antagonist Triptorelin Trigger|GnRH antagonist protocol and triptorelin trigger
546587|NCT00848185|E1|Reported Event|GnRH Antagonist - hCG Trigger|GnRH antagonist protocol and hCG trigger
546588|NCT00848198|B1|Baseline|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
546589|NCT00848198|P1|Participant Flow|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
546590|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
546591|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
546592|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
546593|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
546594|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
546595|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
546596|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
546597|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
546598|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
546599|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
546600|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
546601|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
546602|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
546603|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
546604|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
546605|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
546606|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
546607|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
546608|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
546609|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
546610|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
546611|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
546612|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
546613|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
546614|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
546615|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
546616|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
546617|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
546618|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
546619|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
546620|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
546621|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
557825|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
546623|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
546624|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
546625|NCT00848198|E1|Reported Event|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
546626|NCT00848211|B5|Baseline|Total|Total of all reporting groups
546627|NCT00848211|B4|Baseline|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546628|NCT00848211|B3|Baseline|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546629|NCT00848211|B2|Baseline|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546630|NCT00848211|B1|Baseline|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546631|NCT00848211|P4|Participant Flow|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546632|NCT00848211|P3|Participant Flow|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546633|NCT00848211|P2|Participant Flow|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546634|NCT00848211|P1|Participant Flow|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546635|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546636|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546637|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546638|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546639|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546640|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546641|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546642|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546643|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546644|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546645|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546646|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546647|NCT00848211|E4|Reported Event|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546648|NCT00848211|E3|Reported Event|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546649|NCT00848211|E2|Reported Event|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546650|NCT00848211|E1|Reported Event|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
546651|NCT00848237|B1|Baseline|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
546652|NCT00848237|P1|Participant Flow|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
546653|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
546654|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
546655|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
546656|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
546855|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
546657|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
546658|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
546659|NCT00848237|E1|Reported Event|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.
Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
546660|NCT00848250|B3|Baseline|Total|Total of all reporting groups
546661|NCT00848250|B2|Baseline|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
546662|NCT00848250|B1|Baseline|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
546663|NCT00848250|P2|Participant Flow|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
546664|NCT00848250|P1|Participant Flow|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
546665|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
546666|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
546667|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
546668|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
546669|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
546670|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
546671|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
546672|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
546673|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
546674|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
546675|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
546676|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
546677|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
546678|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
546679|NCT00848250|E2|Reported Event|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
546680|NCT00848250|E1|Reported Event|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
546681|NCT00848354|B3|Baseline|Total|Total of all reporting groups
546856|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
546857|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
546858|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
557826|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
546682|NCT00848354|B2|Baseline|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546683|NCT00848354|B1|Baseline|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546684|NCT00848354|P2|Participant Flow|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546685|NCT00848354|P1|Participant Flow|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection subcutaneously (s.c.) once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546686|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546687|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546688|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546689|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546690|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546691|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546859|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
546860|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
546692|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546693|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546694|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546695|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546696|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546697|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546698|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546699|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546700|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546701|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546861|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
546862|NCT00840658|B5|Baseline|Total|Total of all reporting groups
546702|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546703|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546704|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546705|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546706|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546707|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546708|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546709|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546710|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546711|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546904|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
546905|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
546712|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546713|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546714|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546715|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546716|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546717|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546718|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546719|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546720|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546721|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546906|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
546907|NCT00840879|B3|Baseline|Total|Total of all reporting groups
546722|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546723|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546724|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546725|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546726|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546727|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546728|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546729|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546730|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546731|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546908|NCT00840879|B2|Baseline|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
546732|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546733|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546734|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546735|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546736|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546737|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546738|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546739|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546740|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546741|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546909|NCT00840879|B1|Baseline|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
546742|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546743|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546744|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546745|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546746|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546747|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546748|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546749|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546750|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546751|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546910|NCT00840879|P2|Participant Flow|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
546752|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546753|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546754|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546755|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546756|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546757|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546758|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546759|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546760|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546761|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546911|NCT00840879|P1|Participant Flow|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
546762|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546763|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546764|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546765|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546766|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546767|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546768|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546769|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546770|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546771|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546912|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
546913|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
546772|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546773|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546774|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546775|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546776|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546777|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546778|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546779|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546780|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546781|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546914|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
546915|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
546782|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546783|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546784|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546785|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546786|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546787|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546788|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546789|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546790|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546791|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546916|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
546917|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
546792|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546793|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546794|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546795|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546796|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546797|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546798|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546799|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546800|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546801|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546918|NCT00840996|B3|Baseline|Total|Total of all reporting groups
546919|NCT00840996|B2|Baseline|Placebo|Perioperative equal volume of saline placebo IV infusion
546802|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546803|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546804|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546805|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546806|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546807|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546808|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546809|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546810|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546811|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546920|NCT00840996|B1|Baseline|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
546812|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546813|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546814|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546815|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546816|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546817|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546818|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546819|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546820|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546821|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546921|NCT00840996|P2|Participant Flow|Placebo|Perioperative equal volume of saline placebo IV infusion
547914|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
546822|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546823|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546824|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546825|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546826|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546827|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546828|NCT00848354|E6|Reported Event|DMARD + Methotrexate Phase 2 Year 2|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546829|NCT00848354|E5|Reported Event|Etanercept + Methotrexate Phase 2 Year 2|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546830|NCT00848354|E4|Reported Event|DMARD + Methotrexate Phase 2 Year 1|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546831|NCT00848354|E3|Reported Event|Etanercept + Methotrexate Phase 2 Year 1|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
547188|NCT00842023|B1|Baseline|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
546832|NCT00848354|E2|Reported Event|DMARD + Methotrexate Phase 1|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546833|NCT00848354|E1|Reported Event|Etanercept + Methotrexate Phase 1|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
546834|NCT00848367|B3|Baseline|Total|Total of all reporting groups
546835|NCT00848367|B2|Baseline|Low Attachment Anxiety Condition|These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety.
546836|NCT00848367|B1|Baseline|High Attachment Anxiety Condition|These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety.
546837|NCT00848367|P2|Participant Flow|High Attachment Anxiety Condition|In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety (i.e. others that scored above the cut off). The type of therapy provided was called Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist.
546838|NCT00848367|P1|Participant Flow|Low Attachment Anxiety Condition|In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety (i.e. others that scored below the cut off). The type of therapy administered to this group was Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist.
546839|NCT00848367|O2|Outcome|Low Attachment Anxiety Condition|These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety.
546840|NCT00848367|O1|Outcome|High Attachment Anxiety Condition|These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety.
546841|NCT00848367|O2|Outcome|Low Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
546842|NCT00848367|O1|Outcome|High Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
546843|NCT00848367|E2|Reported Event|Low Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
546844|NCT00848367|E1|Reported Event|High Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
546845|NCT00840632|B3|Baseline|Total|Total of all reporting groups
546846|NCT00840632|B2|Baseline|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
546847|NCT00840632|B1|Baseline|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
546848|NCT00840632|P2|Participant Flow|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
546849|NCT00840632|P1|Participant Flow|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
546850|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
546851|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
546852|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
546853|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
546854|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
557827|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
546863|NCT00840658|B4|Baseline|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one-on-one intervention incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory and Theory of Reasoned Action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV, STIs, pregnancy)."
546864|NCT00840658|B3|Baseline|C:Interactive Sexual Risk & Didactic Safer Injection Education|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI)and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a lecture-format presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
546865|NCT00840658|B2|Baseline|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI) and principles of SCT/TRA to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
546866|NCT00840658|B1|Baseline|A: Didactic Safer Injection & Sexual Activity Education|In each city, 75 women will participate in a 60 minute lecture-format presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
546867|NCT00840658|P4|Participant Flow|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.
This one-on-one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., Human Immuno-deficiency Virus (HIV)infection,Sexually Transmitted Infections (STIs, pregnancy)."
546868|NCT00840658|P3|Participant Flow|C:Interactive Sexual Risk & Didactic Safer Injection Eductatio|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.
This one on one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA)to address the context of unsafe sex and condom use with clients.
In addition, participants will be provided a lecture-type presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
546869|NCT00840658|P2|Participant Flow|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session.
This one on one intervention incorporates elements of motivational interviewing (MI) and principles of social cognitive theory and theory of reasoned action(SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.
In addition, participants will be provided a lecture-type presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
546870|NCT00840658|P1|Participant Flow|A: Didactic Safer Injection & Sexual Activity Education|"In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on Centers for Disease Control and Prevention (CDC) guidelines for Human Immuno-deficiency Virus (HIV) counseling, testing, and referral and materials from Mexico's National Center for AIDS (Acquired Immuno-Deficiency Syndrome)Studies (CENSIDA).
In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."
546871|NCT00840658|O4|Outcome|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.
This one-on-one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., Human Immuno-deficiency Virus (HIV)infection,Sexually Transmitted Infections (STIs, pregnancy)."
546872|NCT00840658|O3|Outcome|C:Interactive Sexual Risk & Didactic Safer Injection Eductatio|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.
This one on one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA)to address the context of unsafe sex and condom use with clients.
In addition, participants will be provided a lecture-type presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
546873|NCT00840658|O2|Outcome|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session.
This one on one intervention incorporates elements of motivational interviewing (MI) and principles of social cognitive theory and theory of reasoned action(SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.
In addition, participants will be provided a lecture-type presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
546922|NCT00840996|P1|Participant Flow|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
557828|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
546874|NCT00840658|O1|Outcome|A: Didactic Safer Injection & Sexual Activity Education|"In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on Centers for Disease Control and Prevention (CDC) guidelines for Human Immuno-deficiency Virus (HIV) counseling, testing, and referral and materials from Mexico's National Center for AIDS (Acquired Immuno-Deficiency Syndrome)Studies (CENSIDA).
In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."
546875|NCT00840658|E4|Reported Event|D: Interactive Injection and Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one-on-one intervention incorporates elements of MI and principles of SCT/TRA to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV, STIs, pregnancy)."
546876|NCT00840658|E3|Reported Event|C:Interactive Sexual Risk Intervention & Didactic Safer|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one on one intervention incorporates elements of MI and principles of SCT/TRA to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a didactic presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
546877|NCT00840658|E2|Reported Event|B: Interactive Injection Risk Intervention and Didactic Safer|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI) and principles of SCT/TRA to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
546878|NCT00840658|E1|Reported Event|A: Didactic Safer Injection and Sexual Activity Education|In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
546879|NCT00840840|B3|Baseline|Total|Total of all reporting groups
546880|NCT00840840|B2|Baseline|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
546881|NCT00840840|B1|Baseline|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
546882|NCT00840840|P2|Participant Flow|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
546883|NCT00840840|P1|Participant Flow|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
546884|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
546885|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
546886|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
546887|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
546888|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
546889|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
546890|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
546891|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
546892|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
546893|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
546894|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
546895|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
546896|NCT00840866|B3|Baseline|Total|Total of all reporting groups
546897|NCT00840866|B2|Baseline|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
546898|NCT00840866|B1|Baseline|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
546899|NCT00840866|P2|Participant Flow|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
546900|NCT00840866|P1|Participant Flow|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
546901|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
546902|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
546903|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
546924|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
546925|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
546926|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
546927|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
546928|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
546929|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
546930|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
546931|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
546932|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
546933|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
546934|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
546935|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
546936|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
546937|NCT00840996|E2|Reported Event|Placebo|Perioperative equal volume of saline placebo IV infusion
546938|NCT00840996|E1|Reported Event|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
546939|NCT00841035|B1|Baseline|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles
erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
546940|NCT00841035|P1|Participant Flow|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles
erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
546941|NCT00841035|O1|Outcome|Eroltinib Added to Standard of Care|150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles
546942|NCT00841035|O1|Outcome|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles
erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
546943|NCT00841035|E1|Reported Event|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles
erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
546944|NCT00841087|B3|Baseline|Total|Total of all reporting groups
546945|NCT00841087|B2|Baseline|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546946|NCT00841087|B1|Baseline|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546947|NCT00841087|P2|Participant Flow|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546948|NCT00841087|P1|Participant Flow|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546949|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546950|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546951|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546952|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546953|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546954|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
547802|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
546955|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546956|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546957|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546958|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546959|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546960|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546961|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546962|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546963|NCT00841087|E2|Reported Event|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546964|NCT00841087|E1|Reported Event|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
546965|NCT00841204|B3|Baseline|Total|Total of all reporting groups
546966|NCT00841204|B2|Baseline|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
546967|NCT00841204|B1|Baseline|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
546968|NCT00841204|P2|Participant Flow|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
546969|NCT00841204|P1|Participant Flow|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
546970|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
546971|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
546972|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
546973|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
546974|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
546975|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
546976|NCT00841204|E2|Reported Event|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
546977|NCT00841204|E1|Reported Event|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
546978|NCT00841269|B1|Baseline|Open Label Uridine Treatment|All participants were Caucasian. There were 5 female participants and 2 male participants.
546979|NCT00841269|P1|Participant Flow|Open Label Uridine Treatment|Participants received fixed-dose uridine 500 mg twice daily for 6 weeks. At each treatment visit, the following rating scales were administered: The CDRS-R, YMRS, and the Columbia-Suicide Severity Rating Scale (C-SSRS)
546980|NCT00841269|O1|Outcome|Open Label Uridine Treatment|
546981|NCT00841269|E1|Reported Event|Uridine 500 mg by Mouth Twice Daily for 6 Weeks|Because this was an open-label study, all participants received the investigational drug uridine.
546982|NCT00841321|B3|Baseline|Total|Total of all reporting groups
546983|NCT00841321|B2|Baseline|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
546984|NCT00841321|B1|Baseline|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
546985|NCT00841321|P2|Participant Flow|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
546986|NCT00841321|P1|Participant Flow|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
546987|NCT00841321|O4|Outcome|Placebo Exit|Placebo, one capsule orally twice a day for 12 weeks.
546988|NCT00841321|O3|Outcome|Placebo Baseline|Placebo, one capsule orally twice a day for 12 weeks.
546989|NCT00841321|O2|Outcome|Ginkgo Exit|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
546990|NCT00841321|O1|Outcome|Ginkgo Baseline|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
546991|NCT00841321|O4|Outcome|Placebo Exit|Placebo, one capsule orally twice a day for 12 weeks.
546992|NCT00841321|O3|Outcome|Placebo Baseline|Placebo, one capsule orally twice a day for 12 weeks.
546993|NCT00841321|O2|Outcome|Ginkgo Exit|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
546994|NCT00841321|O1|Outcome|Ginkgo Baseline|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
546995|NCT00841321|E2|Reported Event|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
546996|NCT00841321|E1|Reported Event|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
547118|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
546997|NCT00841412|B1|Baseline|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
546998|NCT00841412|P2|Participant Flow|Delayed Intervention Group/Units|Delayed Intervention units (control group) was monitored by research staff under usual care conditions.
546999|NCT00841412|P1|Participant Flow|Immediate Intervention Group/Units|Immediate Intervention units received a staff training and management intervention to improve daily nutritional care processes.
547000|NCT00841412|O1|Outcome|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so outcome measures are reported overall for both groups combined.
547001|NCT00841412|E1|Reported Event|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
547002|NCT00841542|B3|Baseline|Total|Total of all reporting groups
547003|NCT00841542|B2|Baseline|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
547004|NCT00841542|B1|Baseline|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference)dosed in second period
547005|NCT00841542|P2|Participant Flow|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
547006|NCT00841542|P1|Participant Flow|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference)dosed in second period
547007|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
547008|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
547009|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
547010|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
547011|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
547012|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
547013|NCT00841555|B4|Baseline|Total|Total of all reporting groups
547014|NCT00841555|B3|Baseline|Dose Level 3|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment
Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547015|NCT00841555|B2|Baseline|Dose Level 2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment
Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547016|NCT00841555|B1|Baseline|Dose Level 1|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment
Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547017|NCT00841555|P3|Participant Flow|Dose Level 3: 75 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment
Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547018|NCT00841555|P2|Participant Flow|Dose Level 2: 65 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment
Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547019|NCT00841555|P1|Participant Flow|Dose Level 1: 50 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment
Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547020|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment
Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547046|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
547021|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment
Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547022|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment
Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547023|NCT00841555|E3|Reported Event|75 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment
Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547024|NCT00841555|E2|Reported Event|65 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547025|NCT00841555|E1|Reported Event|50 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment
Hypofractionated radiation therapy: Patients will undergo HIMRT
Intensity-modulated radiation therapy: Patients undergo HIMRT"
547026|NCT00841659|B3|Baseline|Total|Total of all reporting groups
547027|NCT00841659|B2|Baseline|Paxil® (Reference) First|Paxil® 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
547028|NCT00841659|B1|Baseline|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
547029|NCT00841659|P2|Participant Flow|Paxil® (Reference) First|Paxil® 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
547030|NCT00841659|P1|Participant Flow|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
547031|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
547032|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
547033|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
547034|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
547035|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
547036|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
547037|NCT00841672|B3|Baseline|Total|Total of all reporting groups
547038|NCT00841672|B2|Baseline|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
547039|NCT00841672|B1|Baseline|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
547040|NCT00841672|P2|Participant Flow|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
547041|NCT00841672|P1|Participant Flow|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
547042|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
547043|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
547044|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
547045|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
547116|NCT00841763|O4|Outcome|TIV + aH5N1 (>60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547047|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
547048|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
547049|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
547050|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
547051|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
547052|NCT00841672|E2|Reported Event|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
547053|NCT00841672|E1|Reported Event|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
547054|NCT00841698|B3|Baseline|Total|Total of all reporting groups
547055|NCT00841698|B2|Baseline|Paxil® (Reference First)|Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
547056|NCT00841698|B1|Baseline|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
547057|NCT00841698|P2|Participant Flow|Paxil® (Reference First)|Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
547058|NCT00841698|P1|Participant Flow|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
547059|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
547060|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
547061|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
547062|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
547063|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
547064|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
547065|NCT00841763|B3|Baseline|Total|Total of all reporting groups
547066|NCT00841763|B2|Baseline|PL+ aTIV|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
547067|NCT00841763|B1|Baseline|TIV + aH5N1|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1).
547068|NCT00841763|P4|Participant Flow|PL + aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
547069|NCT00841763|P3|Participant Flow|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547070|NCT00841763|P2|Participant Flow|PL+ aTIV (18 to 60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
547071|NCT00841763|P1|Participant Flow|TIV + aH5N1 (18 to 60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547072|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547073|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547074|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547075|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547076|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547077|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547078|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547079|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas ≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547080|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547081|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547082|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers ≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547117|NCT00841763|O3|Outcome|TIV + aH5N1 (18-60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547083|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers ≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547084|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547085|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547086|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547087|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60yrs) MN Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547088|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547089|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547090|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs)|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547091|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs)|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547092|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547093|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547094|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547095|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547096|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547097|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547098|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547099|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547100|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547101|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547102|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas ≥25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547103|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas ≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547104|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers ≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547105|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547106|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547107|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1).
547108|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547109|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547110|NCT00841763|O4|Outcome|TIV + aH5N1 (>60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547111|NCT00841763|O3|Outcome|TIV + aH5N1 (18-60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547112|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547113|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547114|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547115|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547119|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547120|NCT00841763|O4|Outcome|PL + aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
547121|NCT00841763|O3|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547122|NCT00841763|O2|Outcome|PL+ aTIV (18-60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
547123|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547124|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547125|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
547126|NCT00841763|E4|Reported Event|PL+MF59-eTIV (>60yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV)
547127|NCT00841763|E3|Reported Event|eTIV_a + MF59-eH5N1 (>60 Yrs)|First dose of non adjuvanted seasonal trivalent influenza vaccine (eTIV_a) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (MF59-eH5N1)
547128|NCT00841763|E2|Reported Event|PL+MF59-eTIV (18-60yrs)|First dose of placebo(PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV)
547129|NCT00841763|E1|Reported Event|eTIV_a + MF59-eH5N1 (18-60 Yrs)|First dose of non-adjuvanted seasonal trivalent influenza vaccine (eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
547130|NCT00841776|B3|Baseline|Total|Total of all reporting groups
547131|NCT00841776|B2|Baseline|Ziana|Clindamycin and topical tretinoin gel
547132|NCT00841776|B1|Baseline|Duac|Clindamycin and benzoyl peroxide topical gel
547133|NCT00841776|P2|Participant Flow|Ziana|Clindamycin and topical tretinoin gel
547134|NCT00841776|P1|Participant Flow|Duac|Clindamycin and benzoyl peroxide topical gel
547135|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
547136|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
547137|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
547138|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
547139|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
547140|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
547141|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
547142|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
547143|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
547144|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
547145|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
547146|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
547147|NCT00841776|E2|Reported Event|Ziana|Clindamycin and topical tretinoin gel
547148|NCT00841776|E1|Reported Event|Duac|Clindamycin and benzoyl peroxide topical gel
547149|NCT00841815|B3|Baseline|Total|Total of all reporting groups
547150|NCT00841815|B2|Baseline|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
547151|NCT00841815|B1|Baseline|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
547152|NCT00841815|P2|Participant Flow|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
547153|NCT00841815|P1|Participant Flow|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
547154|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
547155|NCT00841815|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
547156|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
547157|NCT00841815|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
547158|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
547159|NCT00841815|O1|Outcome|Amlodipine Besylate|Amlodipine Besylate 10 mg tablet (test) dosed in either period
547160|NCT00841906|B3|Baseline|Total|Total of all reporting groups
547161|NCT00841906|B2|Baseline|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
547162|NCT00841906|B1|Baseline|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
547187|NCT00842023|B2|Baseline|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
547163|NCT00841906|P2|Participant Flow|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
547164|NCT00841906|P1|Participant Flow|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
547165|NCT00841906|O2|Outcome|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
547166|NCT00841906|O1|Outcome|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
547167|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
547168|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
547169|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
547170|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
547171|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
547172|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
547173|NCT00841906|E2|Reported Event|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
547174|NCT00841906|E1|Reported Event|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
547175|NCT00841971|B3|Baseline|Total|Total of all reporting groups
547176|NCT00841971|B2|Baseline|Fluconazole|"anti-fungal agent
Fluconazole: 400 mg IV for 21 days"
547177|NCT00841971|B1|Baseline|Anidulafungin|"anti-fungal agent
Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
547178|NCT00841971|P2|Participant Flow|Fluconazole|"anti-fungal agent
Fluconazole: 400 mg IV for 21 days"
547179|NCT00841971|P1|Participant Flow|Anidulafungin|"anti-fungal agent
Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
547180|NCT00841971|O2|Outcome|Fluconazole|"anti-fungal agent
Fluconazole: 400 mg IV for 21 days"
547181|NCT00841971|O1|Outcome|Anidulafungin|"anti-fungal agent
Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
547182|NCT00841971|O2|Outcome|Fluconazole|"anti-fungal agent
Fluconazole: 400 mg IV for 21 days"
547183|NCT00841971|O1|Outcome|Anidulafungin|"anti-fungal agent
Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
547184|NCT00841971|E2|Reported Event|Fluconazole|"anti-fungal agent
Fluconazole: 400 mg IV for 21 days"
547185|NCT00841971|E1|Reported Event|Anidulafungin|"anti-fungal agent
Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
547186|NCT00842023|B3|Baseline|Total|Total of all reporting groups
547189|NCT00842023|P2|Participant Flow|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
547190|NCT00842023|P1|Participant Flow|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
547191|NCT00842023|O2|Outcome|Nitroglycerin|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
547192|NCT00842023|O1|Outcome|Nesiritide|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
547193|NCT00842023|O2|Outcome|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
547194|NCT00842023|O1|Outcome|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
547195|NCT00842023|O2|Outcome|Nitroglycerin|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment
547196|NCT00842023|O1|Outcome|Nesiritide|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
547197|NCT00842023|E2|Reported Event|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
547198|NCT00842023|E1|Reported Event|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
547199|NCT00842075|B3|Baseline|Total|Total of all reporting groups
547200|NCT00842075|B2|Baseline|2 Usual Regimen|Usual bolus insulin dose at each meal
547201|NCT00842075|B1|Baseline|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
547202|NCT00842075|P2|Participant Flow|2 Usual Regimen|Usual bolus insulin dose at each meal
547203|NCT00842075|P1|Participant Flow|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
547204|NCT00842075|O2|Outcome|2 Usual Regimen|Usual bolus insulin dose at each meal
547205|NCT00842075|O1|Outcome|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
547206|NCT00842075|O2|Outcome|2 Usual Regimen|Usual bolus insulin dose at each meal
547207|NCT00842075|O1|Outcome|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
547208|NCT00842075|E2|Reported Event|2 Usual Regimen|Usual bolus insulin dose at each meal
547209|NCT00842075|E1|Reported Event|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
547210|NCT00842153|B3|Baseline|Total|Total of all reporting groups
547211|NCT00842153|B2|Baseline|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547212|NCT00842153|B1|Baseline|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547213|NCT00842153|P2|Participant Flow|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547214|NCT00842153|P1|Participant Flow|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547215|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547216|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547217|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547218|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547219|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547220|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547221|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547222|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547223|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547224|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547225|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547226|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547227|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547228|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547229|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547230|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
557829|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
547231|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547232|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547233|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547234|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547235|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547236|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547237|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547238|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547239|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547240|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547241|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547242|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547243|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547244|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547245|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547246|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547247|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547248|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547249|NCT00842153|E2|Reported Event|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
547250|NCT00842153|E1|Reported Event|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
547251|NCT00842231|B1|Baseline|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
547252|NCT00842231|P1|Participant Flow|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
547253|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
547254|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
547255|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
547256|NCT00842231|E1|Reported Event|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
547257|NCT00842244|B1|Baseline|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547258|NCT00842244|P1|Participant Flow|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547259|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547803|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547260|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547261|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in Pharmacokinetic (PK) expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547262|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in Pharmacokinetic (PK) expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547263|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547264|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547265|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547266|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547267|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547268|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547269|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547270|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547271|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547272|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547273|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (MTD Determination)|Axitinib (AG-013736) 5 mg tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547274|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (MTD Determination)|Axitinib (AG-013736) 5 mg tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547275|NCT00842244|E1|Reported Event|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
547276|NCT00842257|B1|Baseline|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
547277|NCT00842257|P1|Participant Flow|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
547278|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
547279|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
547280|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
547281|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
547282|NCT00842257|E1|Reported Event|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
547283|NCT00842335|B1|Baseline|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
547284|NCT00842335|P1|Participant Flow|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
547285|NCT00842335|O1|Outcome|All Subjects|
547286|NCT00842335|O1|Outcome|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
547287|NCT00842335|O1|Outcome|All Subjects|"The starting dose of JI-101 for patients in the first cohort was 100 mg QD. All patients took JI-101 without food on Day 0, with a high fat meal on Day 2, and with a regular diet on Day 3 onwards. Patients in the first three cohorts were dosed QD. Based on PK characteristics observed from the first eight patients (Cohort 1, Cohort 2, and Cohort 3), subsequent cohorts were dosed BID.
After the first eight patients, the combined PK profiles of the enrolled patients were studied. These assessments indicated that the PK profile for JI-101 supported BID dosing. Therefore, BID dosing was administered to patients who enrolled in the study following the effective date of Protocol"
547288|NCT00842335|O1|Outcome|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
547289|NCT00842335|E1|Reported Event|JI-101|Maximum tolerated dose
547290|NCT00842348|B3|Baseline|Total|Total of all reporting groups
547291|NCT00842348|B2|Baseline|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
547292|NCT00842348|B1|Baseline|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
547293|NCT00842348|P2|Participant Flow|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
547294|NCT00842348|P1|Participant Flow|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding double blind (DB) study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
547295|NCT00842348|O2|Outcome|Placebo - Randomised Treatment in Study 726|All patients randomised to placebo in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
547296|NCT00842348|O1|Outcome|Lanreotide Autogel - Randomised Treatment in Study 726|All patients randomised to lanreotide 120 mg (Autogel formulation) in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
547297|NCT00842348|O3|Outcome|Total|All patients treated with Lanreotide 120 mg (Autogel formulation) in the open label study.
547298|NCT00842348|O2|Outcome|Placebo|Patients who received placebo in the preceding double DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
547299|NCT00842348|O1|Outcome|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
547300|NCT00842348|E3|Reported Event|Total|All patients treated with lanreotide 120 mg (Autogel formulation) in the open label study.
547301|NCT00842348|E2|Reported Event|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
547302|NCT00842348|E1|Reported Event|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
547303|NCT00842361|B3|Baseline|Total|Total of all reporting groups
547304|NCT00842361|B2|Baseline|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
547305|NCT00842361|B1|Baseline|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
547306|NCT00842361|P2|Participant Flow|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
547307|NCT00842361|P1|Participant Flow|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
547308|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
547309|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
547310|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
547311|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
547312|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
547313|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
547314|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
547315|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
547316|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
547317|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
547318|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
547319|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
547320|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
547321|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
547322|NCT00842361|E2|Reported Event|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
547323|NCT00842361|E1|Reported Event|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
547324|NCT00842543|B5|Baseline|Total|Total of all reporting groups
547325|NCT00842543|B4|Baseline|Lean Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
547326|NCT00842543|B3|Baseline|Overweight Placebo|Overweight Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
547327|NCT00842543|B2|Baseline|Lean FVJC|Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
547328|NCT00842543|B1|Baseline|Overweight FVJC|Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
547329|NCT00842543|P4|Participant Flow|Lean Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months
547330|NCT00842543|P3|Participant Flow|Overweight Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
547331|NCT00842543|P2|Participant Flow|Lean FVJC|Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
547332|NCT00842543|P1|Participant Flow|Overweight FVJC|Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
547333|NCT00842543|O4|Outcome|Lean Placebo|
547334|NCT00842543|O3|Outcome|Overweight Placebo|Reesults displayed for overweight boys who received 6 months of Placebo intervention
547335|NCT00842543|O2|Outcome|Lean FVJC|
547336|NCT00842543|O1|Outcome|Overweight FVJC|Results displayed for overweight boys who received 6 months of FVJC intervention
547337|NCT00842543|O2|Outcome|Lean|Lean boys prior to receiving intervention.
547338|NCT00842543|O1|Outcome|Overweight|Overweight boys prior to receiving intervention.
547339|NCT00842543|E4|Reported Event|Lean Placebo|Lean Boys receiving Placebo, 1 capsule, twice a day, for 6 months.
547340|NCT00842543|E3|Reported Event|Overweight Placebo|Overweight Boys receiving Placebo, 1 capsule, twice a day, for 6 months.
547341|NCT00842543|E2|Reported Event|Lean FVJC|Lean Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
547342|NCT00842543|E1|Reported Event|Overweight FVJC|Overweight Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
547343|NCT00842608|B5|Baseline|Total|Total of all reporting groups
547344|NCT00842608|B4|Baseline|Haldol Ineligible Usual Care|"Usual Care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547345|NCT00842608|B3|Baseline|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.
Patients are randomized and will still receive:
reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
547346|NCT00842608|B2|Baseline|Haloperidol Eligible Usual Care|"Usual care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547347|NCT00842608|B1|Baseline|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
547348|NCT00842608|P4|Participant Flow|Haldol Ineligible Usual Care|"Usual Care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547349|NCT00842608|P3|Participant Flow|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.
Patients are randomized and will still receive:
reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
547350|NCT00842608|P2|Participant Flow|Haloperidol Eligible Usual Care|"Usual care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547351|NCT00842608|P1|Participant Flow|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
547352|NCT00842608|O4|Outcome|Haldol Ineligible Usual Care|"Usual Care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547353|NCT00842608|O3|Outcome|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.
Patients are randomized and will still receive:
reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
547354|NCT00842608|O2|Outcome|Haloperidol Eligible Usual Care|"Usual care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547355|NCT00842608|O1|Outcome|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
547356|NCT00842608|O4|Outcome|Haldol Ineligible Usual Care|"Usual Care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547357|NCT00842608|O3|Outcome|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.
Patients are randomized and will still receive:
reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
547358|NCT00842608|O2|Outcome|Haloperidol Eligible Usual Care|"Usual care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547359|NCT00842608|O1|Outcome|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
547360|NCT00842608|O4|Outcome|Haldol Ineligible Usual Care|"Usual Care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547361|NCT00842608|O3|Outcome|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.
Patients are randomized and will still receive:
reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
547362|NCT00842608|O2|Outcome|Haloperidol Eligible Usual Care|"Usual care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547413|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, twice daily (BID) orally + placebo finasteride
547414|NCT00842751|O3|Outcome|Acyline + Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 1mg finasteride
547363|NCT00842608|O1|Outcome|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
547364|NCT00842608|E4|Reported Event|Haldol Ineligible Usual Care|"Usual Care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547365|NCT00842608|E3|Reported Event|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.
Patients are randomized and will still receive:
reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
547366|NCT00842608|E2|Reported Event|Haloperidol Eligible Usual Care|"Usual care
Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
547367|NCT00842608|E1|Reported Event|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
547368|NCT00842712|B8|Baseline|Total|Total of all reporting groups
547369|NCT00842712|B7|Baseline|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547370|NCT00842712|B6|Baseline|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547371|NCT00842712|B5|Baseline|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547372|NCT00842712|B4|Baseline|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547373|NCT00842712|B3|Baseline|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547374|NCT00842712|B2|Baseline|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547375|NCT00842712|B1|Baseline|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547415|NCT00842751|O2|Outcome|Acyline + Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 0.5mg finasteride
547416|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg subcutaneous (SC) +Testosterone Undecanoate 200 mg, BID orally + Placebo finasteride
547376|NCT00842712|P7|Participant Flow|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547377|NCT00842712|P6|Participant Flow|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547378|NCT00842712|P5|Participant Flow|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547379|NCT00842712|P4|Participant Flow|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547380|NCT00842712|P3|Participant Flow|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547381|NCT00842712|P2|Participant Flow|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547382|NCT00842712|P1|Participant Flow|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547383|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547384|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547385|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547386|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547417|NCT00842751|O3|Outcome|Acyline +Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 1 mg, BID orally
547418|NCT00842751|O2|Outcome|Acyline +Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5 mg, BID orally
547419|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + Placebo Finasteride
547804|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547387|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547388|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547389|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547390|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547391|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547392|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547393|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547394|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547395|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547420|NCT00842751|E3|Reported Event|Third Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, twice daily orally + Finasteride 1mg, twice a day, orally
547421|NCT00842751|E2|Reported Event|Second Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5mg, twice a day, orally
547422|NCT00842751|E1|Reported Event|First Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, twice daily, orally + Finasteride placebo, twice daily, orally
547396|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547397|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547398|NCT00842712|O4|Outcome|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547399|NCT00842712|O3|Outcome|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547400|NCT00842712|O2|Outcome|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547401|NCT00842712|O1|Outcome|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547402|NCT00842712|E7|Reported Event|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547403|NCT00842712|E6|Reported Event|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547404|NCT00842712|E5|Reported Event|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
547405|NCT00842712|E4|Reported Event|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547406|NCT00842712|E3|Reported Event|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547407|NCT00842712|E2|Reported Event|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547408|NCT00842712|E1|Reported Event|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
547409|NCT00842751|B1|Baseline|All Study Participants|
547410|NCT00842751|P1|Participant Flow|Acyline + Testosterone Undecanoate + Placebo Finasteride|Acyline 300 mcg/kg +Testosterone Undecanoate 200 mg, BID orally + placebo finasteride
547411|NCT00842751|O3|Outcome|Acyline +Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 1mg finasteride
547412|NCT00842751|O2|Outcome|Acyline + Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 0.5mg finasteride
547424|NCT00842829|B2|Baseline|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
547425|NCT00842829|B1|Baseline|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
547426|NCT00842829|P3|Participant Flow|FBT - Treatment and Continuation Periods|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days). The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
547427|NCT00842829|P2|Participant Flow|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
547428|NCT00842829|P1|Participant Flow|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
547429|NCT00842829|O4|Outcome|FBT - Continuation Period|The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
547430|NCT00842829|O3|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547431|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
547432|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
547433|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547434|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547435|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547436|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547437|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547438|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547439|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547440|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547441|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547442|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547443|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547444|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547445|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547446|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547447|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547448|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547449|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547805|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547450|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547451|NCT00842829|O2|Outcome|60 Minutes|Participant assessments of medication performance 60 minutes after dosing during the Treatment Period.
547452|NCT00842829|O1|Outcome|30 Minutes|Participant assessments of medication performance 30 minutes after dosing during the Treatment Period.
547453|NCT00842829|O2|Outcome|During Treatment Period|The treatment period included participants who identified an effective dose during the earlier study period and used that dose for BTP episodes during the Treatment Period.
547454|NCT00842829|O1|Outcome|During Titration Period|The titration period consisted of up to 7 days of treatment in which participants used increasing dosage of study drug in order to identify the effective dose for their breakthrough pain episodes.
547455|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
547456|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
547457|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
547458|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
547459|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
547460|NCT00842829|E1|Reported Event|FBT - All Doses and Study Periods|Participants took fentanyl buccal tables (FBT) with doses between 100-800 mcg
547461|NCT00842946|B3|Baseline|Total|Total of all reporting groups
547462|NCT00842946|B2|Baseline|Habituation|Behavioral exposure within the context of habituation.
547463|NCT00842946|B1|Baseline|Acceptance|Behavioral exposure within the context of psychological acceptance.
547464|NCT00842946|P2|Participant Flow|Habituation|Behavioral exposure within the context of habituation.
547465|NCT00842946|P1|Participant Flow|Acceptance|Behavioral exposure within the context of psychological acceptance.
547466|NCT00842946|O2|Outcome|Habituation|Behavioral exposure within the context of habituation.
547467|NCT00842946|O1|Outcome|Acceptance|Behavioral exposure within the context of psychological acceptance.
547468|NCT00842946|E2|Reported Event|Habituation|Behavioral exposure within the context of habituation.
547469|NCT00842946|E1|Reported Event|Acceptance|Behavioral exposure within the context of psychological acceptance.
547470|NCT00848484|B3|Baseline|Total|Total of all reporting groups
547471|NCT00848484|B2|Baseline|Placebo / MK5757|"Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2.
Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.
Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
547472|NCT00848484|B1|Baseline|MK5757 / Placebo|"Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2.
Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.
Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
547473|NCT00848484|P2|Participant Flow|Placebo / MK5757|"Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2.
Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.
Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
547474|NCT00848484|P1|Participant Flow|MK5757 / Placebo|"Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2.
Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.
Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
547475|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547645|NCT00849680|P8|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
547476|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547477|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547478|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547479|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547480|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547481|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547482|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547483|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547484|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547485|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547486|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547487|NCT00848484|E2|Reported Event|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547488|NCT00848484|E1|Reported Event|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
547489|NCT00848497|B3|Baseline|Total|Total of all reporting groups
547490|NCT00848497|B2|Baseline|Arm 2|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
547491|NCT00848497|B1|Baseline|Arm 1|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
547492|NCT00848497|P2|Participant Flow|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
547493|NCT00848497|P1|Participant Flow|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
547494|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
547495|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
547496|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
547497|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
547498|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
547499|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
547500|NCT00848497|O2|Outcome|Placebo Testim + Viagra|"Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
SHIM at Baseline = 0 SHIM at 5 months = 0"
547501|NCT00848497|O1|Outcome|Testim + Viagra|"Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
SHIM at Baseline = N/A SHIM at 5 months = N/A"
547502|NCT00848497|E2|Reported Event|Arm 2|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
547503|NCT00848497|E1|Reported Event|Arm 1|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
547504|NCT00848510|B5|Baseline|Total|Total of all reporting groups
547505|NCT00848510|B4|Baseline|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547506|NCT00848510|B3|Baseline|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547646|NCT00849680|P7|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
547507|NCT00848510|B2|Baseline|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547508|NCT00848510|B1|Baseline|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547509|NCT00848510|P4|Participant Flow|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547510|NCT00848510|P3|Participant Flow|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547511|NCT00848510|P2|Participant Flow|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547512|NCT00848510|P1|Participant Flow|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 milligram (mg) at Weeks 1, 3 and 5. In case of clinical benefit (stable disease [SD], complete response [CR], or partial response [PR]) as assessed by the Response Evaluation Criteria in Solid Tumors version (RECIST) Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547513|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547514|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547515|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547516|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547517|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547518|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547519|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547520|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547647|NCT00849680|P6|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
557830|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
547521|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547522|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547523|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547524|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547525|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547526|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547527|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547528|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547529|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547530|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547531|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547532|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547533|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547534|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547576|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
557831|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
547535|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547536|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547537|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547538|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547539|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547540|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547541|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547542|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547543|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547544|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547545|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547546|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547547|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547548|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547577|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
557832|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
547549|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547550|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547551|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547552|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547553|NCT00848510|E4|Reported Event|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547554|NCT00848510|E3|Reported Event|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547555|NCT00848510|E2|Reported Event|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547556|NCT00848510|E1|Reported Event|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
547557|NCT00848536|B3|Baseline|Total|Total of all reporting groups
547558|NCT00848536|B2|Baseline|TRAVATAN|One drop once daily in the evening for 3 months
547559|NCT00848536|B1|Baseline|TRAVATAN APS|One drop once daily in the evening for 3 months
547560|NCT00848536|P2|Participant Flow|TRAVATAN|One drop once daily in the evening for 3 months
547561|NCT00848536|P1|Participant Flow|TRAVATAN APS|One drop once daily in the evening for 3 months
547562|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
547563|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
547564|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
547565|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
547566|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
547567|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
547568|NCT00848536|E2|Reported Event|TRAVATAN|One drop once daily in the evening for 3 months
547569|NCT00848536|E1|Reported Event|TRAVATAN APS|One drop once daily in the evening for 3 months
547570|NCT00848549|B3|Baseline|Total|Total of all reporting groups
547571|NCT00848549|B2|Baseline|Carbamazepine|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547572|NCT00848549|B1|Baseline|Zonisamide|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547573|NCT00848549|P2|Participant Flow|Carbamazepine|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547574|NCT00848549|P1|Participant Flow|Zonisamide|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547575|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547643|NCT00849680|B2|Baseline|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
547578|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547579|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547580|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547581|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547582|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547583|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547584|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547585|NCT00848549|E4|Reported Event|Carbamazepine (Base Study 310, NCT00477295)|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
547586|NCT00848549|E3|Reported Event|Zonisamide (Base Study 310, NCT00477295)|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
547587|NCT00848549|E2|Reported Event|Carbamazepine (Extension Study 314, NCT00848549)|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547588|NCT00848549|E1|Reported Event|Zonisamide (Extension Study 314, NCT00848549)|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
547589|NCT00848744|B1|Baseline|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
547590|NCT00848744|P1|Participant Flow|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
547591|NCT00848744|O2|Outcome|Formulation B|Participants used salicylic acid Formulation A on either the right or left side of the face.
547592|NCT00848744|O1|Outcome|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
547593|NCT00848744|E1|Reported Event|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
547594|NCT00848783|B4|Baseline|Total|Total of all reporting groups
547595|NCT00848783|B3|Baseline|Induction Treatment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
547596|NCT00848783|B2|Baseline|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
547597|NCT00848783|B1|Baseline|A-with IP Floxuridine|"Induction treatment:
Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.
Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.
Randomization
Surgery.
Postoperative IP treatment:
Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once
Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
547598|NCT00848783|P3|Participant Flow|Induction Treartment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
547599|NCT00848783|P2|Participant Flow|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
547600|NCT00848783|P1|Participant Flow|A-with IP Floxuridine|"Induction treatment:
Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.
Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.
Randomization
Surgery.
Postoperative IP treatment:
Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once
Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
547601|NCT00848783|O2|Outcome|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
547602|NCT00848783|O1|Outcome|A-with IP Floxuridine|"Induction treatment:
Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.
Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.
Randomization
Surgery.
Postoperative IP treatment:
Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once
Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
547603|NCT00848783|E2|Reported Event|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
547604|NCT00848783|E1|Reported Event|A-with IP Floxuridine|"Induction treatment:
Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.
Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.
Randomization
Surgery.
Postoperative IP treatment:
Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once
Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
547605|NCT00849472|B1|Baseline|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547606|NCT00849472|P1|Participant Flow|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants (par.) were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547607|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547608|NCT00849472|O1|Outcome|Overall Study Arm|
547609|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547610|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547611|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547612|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547613|NCT00849472|O1|Outcome|Overall Study Arm|
547614|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547615|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547644|NCT00849680|B1|Baseline|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
547616|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547617|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547618|NCT00849472|E1|Reported Event|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
547619|NCT00849485|B3|Baseline|Total|Total of all reporting groups
547620|NCT00849485|B2|Baseline|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
547621|NCT00849485|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
547622|NCT00849485|P2|Participant Flow|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
547623|NCT00849485|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
547624|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
547625|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
547626|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
547627|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
547628|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
547629|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
547630|NCT00849524|B1|Baseline|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
547631|NCT00849524|P1|Participant Flow|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
547632|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
547633|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
547634|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
547635|NCT00849524|E1|Reported Event|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
547636|NCT00849680|B9|Baseline|Total|Total of all reporting groups
547637|NCT00849680|B8|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
547638|NCT00849680|B7|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
547639|NCT00849680|B6|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
547640|NCT00849680|B5|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
547641|NCT00849680|B4|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
547642|NCT00849680|B3|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
548876|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
547648|NCT00849680|P5|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
547649|NCT00849680|P4|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
547650|NCT00849680|P3|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
547651|NCT00849680|P2|Participant Flow|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
547652|NCT00849680|P1|Participant Flow|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
547653|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
547654|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
547655|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
547656|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
547657|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
547658|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
547659|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
547660|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
547661|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
547662|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
547663|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
547664|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
547665|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
547666|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
547667|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
547668|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
547669|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
547670|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
547671|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
547672|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
547673|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
547674|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
547675|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
547676|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
547677|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
547678|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
547679|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
547680|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
547681|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
547682|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
547801|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547683|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
547684|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
547685|NCT00849680|E8|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10[11] vp/Dose)|
547686|NCT00849680|E7|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[10] vp/Dose)|
547687|NCT00849680|E6|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[9] vp/Dose)|
547688|NCT00849680|E5|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[8] vp/Dose)|
547689|NCT00849680|E4|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[7] vp/Dose)|
547690|NCT00849680|E3|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[6] vp/Dose)|
547691|NCT00849680|E2|Reported Event|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10[9] vp/Dose)|
547692|NCT00849680|E1|Reported Event|Placebo|
547693|NCT00849693|B5|Baseline|Total|Total of all reporting groups
547694|NCT00849693|B4|Baseline|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547695|NCT00849693|B3|Baseline|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
547696|NCT00849693|B2|Baseline|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547697|NCT00849693|B1|Baseline|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547698|NCT00849693|P4|Participant Flow|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547699|NCT00849693|P3|Participant Flow|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
547700|NCT00849693|P2|Participant Flow|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547701|NCT00849693|P1|Participant Flow|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547702|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547703|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
547704|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547705|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547706|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
547707|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
547708|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
547709|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
547710|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547711|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
547712|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547713|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547714|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
547715|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
547716|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
547717|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
547718|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547719|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
547720|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547721|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547722|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
547723|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
547724|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
547725|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
547726|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547727|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
547728|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547729|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547730|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
547731|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
547732|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
547733|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
547734|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547735|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
547736|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547737|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547738|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
547739|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
547740|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
547741|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
547742|NCT00849693|O3|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
547743|NCT00849693|O2|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
547744|NCT00849693|O1|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
547745|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547746|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
547747|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547748|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
547749|NCT00849693|O2|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
547750|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
547751|NCT00849693|E8|Reported Event|Placebo/Duloxetine - Extension|Duloxetine 60-120 mg , orally, once daily for 6 months
547752|NCT00849693|E7|Reported Event|Fluoxetine 20 mg - Extension|Fluoxetine 20-40 mg, orally, once daily for 6 months
547753|NCT00849693|E6|Reported Event|Duloxetine 30 mg - Extension|"Duloxetine 60-120 mg , orally, once daily for 6 months
One participant who had completed the acute treatment phase and didn't go into the extension phase, was accidentally dispensed the drug at the last visit of the acute treatment phase. Based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs; resulting in one more participant being analyzed for AEs than the number of participants who started the extension phase [see Participant Flow section])."
547754|NCT00849693|E5|Reported Event|Duloxetine 60 mg - Extension|Duloxetine 60-120 mg , orally, once daily for 6 months
547755|NCT00849693|E4|Reported Event|Placebo - Acute|Placebo capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks
547756|NCT00849693|E3|Reported Event|Fluoxetine 20 mg - Acute|Fluoxetine 20 mg, orally, once daily for 10 weeks
547757|NCT00849693|E2|Reported Event|Duloxetine 30 mg - Acute|Duloxetine 30 mg, orally, once daily for 10 weeks
547758|NCT00849693|E1|Reported Event|Duloxetine 60 mg - Acute|Duloxetine 60 mg, orally, once daily for 10 weeks
547759|NCT00849797|B3|Baseline|Total|Total of all reporting groups
547760|NCT00849797|B2|Baseline|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
547761|NCT00849797|B1|Baseline|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
547762|NCT00849797|P2|Participant Flow|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
547763|NCT00849797|P1|Participant Flow|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
547764|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
547765|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547766|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
547767|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547768|NCT00849797|O2|Outcome|Trileptal|Trileptal® 600 mg Tablet (reference) dosed in either period
547769|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547770|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
547771|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547772|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
547773|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547774|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
547775|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547776|NCT00849810|B1|Baseline|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.
Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
547777|NCT00849810|P1|Participant Flow|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.
Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
547778|NCT00849810|O1|Outcome|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.
Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
547779|NCT00849810|E1|Reported Event|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.
Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
547780|NCT00849862|B3|Baseline|Total|Total of all reporting groups
547781|NCT00849862|B2|Baseline|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
547782|NCT00849862|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
547783|NCT00849862|P2|Participant Flow|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
547784|NCT00849862|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
547785|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
547786|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
547787|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
547788|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
547789|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
547790|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
547791|NCT00849875|B4|Baseline|Total|Total of all reporting groups
547792|NCT00849875|B3|Baseline|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547793|NCT00849875|B2|Baseline|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547794|NCT00849875|B1|Baseline|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547795|NCT00849875|P1|Participant Flow|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547796|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547797|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547798|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547799|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547800|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547806|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547807|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547808|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547809|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547810|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547811|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547812|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547813|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547814|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547815|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547816|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547817|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547818|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547819|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547820|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547821|NCT00849875|O3|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547822|NCT00849875|O2|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547823|NCT00849875|O1|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547824|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547825|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547826|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547827|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547828|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547829|NCT00849875|O3|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547830|NCT00849875|O2|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547831|NCT00849875|O1|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547832|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547833|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547834|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547835|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547836|NCT00849875|O3|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547837|NCT00849875|O2|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547838|NCT00849875|O1|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547915|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
547839|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547840|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547841|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547842|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547843|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547844|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547845|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547846|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547847|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening
547848|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547849|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547850|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547851|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547852|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547853|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547854|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547855|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547856|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547857|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547858|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547859|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547860|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547861|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547862|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547863|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening
547864|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547865|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547866|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547867|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547913|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
547868|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547869|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
547870|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547871|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547872|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547873|NCT00849875|E1|Reported Event|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
547874|NCT00849901|B4|Baseline|Total|Total of all reporting groups
547875|NCT00849901|B3|Baseline|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
547876|NCT00849901|B2|Baseline|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
547877|NCT00849901|B1|Baseline|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
547878|NCT00849901|P3|Participant Flow|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
547879|NCT00849901|P2|Participant Flow|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
547880|NCT00849901|P1|Participant Flow|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
547881|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
547882|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
547883|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
547884|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
547885|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
547886|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
547887|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
547888|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
547889|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
547890|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
547891|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
547892|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
547893|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
547894|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
547895|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
547896|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
547897|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
547898|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
547899|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
547900|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
547901|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
547902|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
547903|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
547904|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
547905|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
547906|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
547907|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
547908|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
547909|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
547910|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
547911|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
547912|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
547916|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
547917|NCT00849901|E6|Reported Event|Placebo/Duloxetine - Extension|Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
547918|NCT00849901|E5|Reported Event|Fluoxetine - Extension|Received fluoxetine 20 and/or 40 mg PO, QD during extension phase. One participant had discontinued the acute phase due to an adverse event but was accidentally dispensed drug at the last visit of the acute phase, thus based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs) (resulting in one more participant being analyzed for AEs than started the extension phase in the Participant Flow section).
547919|NCT00849901|E4|Reported Event|Duloxetine - Extension|Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
547920|NCT00849901|E3|Reported Event|Placebo - Acute|Received placebo PO, QD during acute treatment phase
547921|NCT00849901|E2|Reported Event|Fluoxetine - Acute|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
547922|NCT00849901|E1|Reported Event|Duloxetine - Acute|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
547923|NCT00849940|B1|Baseline|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.
CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
547924|NCT00849940|P1|Participant Flow|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.
CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
547925|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.
CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
547926|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.
CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
547927|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.
CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
547928|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.
CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
547929|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.
CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
547930|NCT00849940|E1|Reported Event|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.
CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
547931|NCT00850031|B1|Baseline|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
AcuFocus Corneal Inlay ACI 7000PDT: Inlay implanted in cornea for improvement of near vision"
547932|NCT00850031|P1|Participant Flow|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
547933|NCT00850031|O1|Outcome|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
547934|NCT00850031|O1|Outcome|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
547935|NCT00850031|E1|Reported Event|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
547936|NCT00850070|B3|Baseline|Total|Total of all reporting groups
547937|NCT00850070|B2|Baseline|Placebo|sugar pill
547938|NCT00850070|B1|Baseline|Sapropterin|tetrahydrobiopterin (BH4)
547939|NCT00850070|P2|Participant Flow|Placebo|sugar pill; matched identical tablet, dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
547940|NCT00850070|P1|Participant Flow|Sapropterin|tetrahydrobiopterin (BH4); dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
547941|NCT00850070|O2|Outcome|Placebo|sugar pill
547942|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
547943|NCT00850070|O2|Outcome|Placebo|sugar pill
547944|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
547945|NCT00850070|O2|Outcome|Placebo|sugar pill
547946|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
547947|NCT00850070|O2|Outcome|Placebo|sugar pill
547948|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
547949|NCT00850070|O2|Outcome|Placebo|sugar pill
547950|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
547951|NCT00850070|O2|Outcome|Placebo|sugar pill
547952|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
547953|NCT00850070|E2|Reported Event|Placebo|sugar pill
547954|NCT00850070|E1|Reported Event|Sapropterin|sapropterin 20 mg/kg/day
547955|NCT00850096|B3|Baseline|Total|Total of all reporting groups
547956|NCT00850096|B2|Baseline|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
547957|NCT00850096|B1|Baseline|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
547958|NCT00850096|P2|Participant Flow|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
557833|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
547959|NCT00850096|P1|Participant Flow|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
547960|NCT00850096|O2|Outcome|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
547961|NCT00850096|O1|Outcome|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
547962|NCT00850096|O2|Outcome|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
547963|NCT00850096|O1|Outcome|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
547964|NCT00850096|E2|Reported Event|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
547965|NCT00850096|E1|Reported Event|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
547966|NCT00850135|B1|Baseline|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
547967|NCT00850135|P1|Participant Flow|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
547968|NCT00850135|O2|Outcome|Participants With AUC 130 >22,000|AUC-130 values were divided into“high” and “low” at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
547969|NCT00850135|O1|Outcome|Participants With AUC 130 <= 22,000|AUC-130 values were divided into“high” and “low” at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
547970|NCT00850135|O1|Outcome|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
547971|NCT00850135|E1|Reported Event|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
547972|NCT00850174|B3|Baseline|Total|Total of all reporting groups
547973|NCT00850174|B2|Baseline|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
547974|NCT00850174|B1|Baseline|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
547975|NCT00850174|P2|Participant Flow|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
547976|NCT00850174|P1|Participant Flow|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
547977|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
547978|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547979|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
547980|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547981|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
547982|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547983|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
547984|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547985|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
547986|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547987|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
547988|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
547989|NCT00850200|B1|Baseline|Proton Therapy Plan Compared to IMRT and Conventional RT|Each patient has a proton, IMRT and conventional plan done prior to treatment for dosimetric comparison of the primary endpoint which is the percent of the body that receives 4 Gray (%V4). The plan that delivers the smallest %V4 will be the plan that is pursued for actual treatment. Therefore, each patient will have three treatment plans, but will only be treated with one of these three plans (the superior one).
547990|NCT00850200|P1|Participant Flow|Optimal Treatment Plan|"Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).
The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm."
547991|NCT00850200|O3|Outcome|Intensity Modulated Radiation Plan|Intensity Modulated Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
547992|NCT00850200|O2|Outcome|Conventional Photon Radiation Plan|Conventional Photon Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
547993|NCT00850200|O1|Outcome|Proton Radiation Plan|Proton Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
547994|NCT00850200|E1|Reported Event|Superior Treatment Plan|"Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).
The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm."
547995|NCT00850343|B5|Baseline|Total|Total of all reporting groups
547996|NCT00850343|B4|Baseline|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
547997|NCT00850343|B3|Baseline|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
547998|NCT00850343|B2|Baseline|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
547999|NCT00850343|B1|Baseline|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548000|NCT00850343|P4|Participant Flow|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548001|NCT00850343|P3|Participant Flow|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548002|NCT00850343|P2|Participant Flow|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548003|NCT00850343|P1|Participant Flow|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548004|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548005|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548006|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548007|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548008|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548009|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548010|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548011|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548012|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548130|NCT00850759|O1|Outcome|Virtual Reality|street-crossing training in a virtual pedestrian environment
548013|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548014|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548015|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548016|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548017|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548018|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548019|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548020|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548021|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548022|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548023|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548024|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548025|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548026|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548027|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548028|NCT00850343|E4|Reported Event|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548029|NCT00850343|E3|Reported Event|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548030|NCT00850343|E2|Reported Event|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548031|NCT00850343|E1|Reported Event|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548032|NCT00850395|B1|Baseline|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548033|NCT00850395|P1|Participant Flow|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548034|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548035|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548036|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548037|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548038|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548039|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548040|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548041|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548042|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548043|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548044|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548045|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548046|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548047|NCT00850395|E1|Reported Event|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
548048|NCT00850421|B1|Baseline|Botulinum Toxin Type A|
548049|NCT00850421|P1|Participant Flow|Botulinum Toxin Type A|
548050|NCT00850421|O1|Outcome|Botulinum Toxin Type A|
548051|NCT00850421|E1|Reported Event|Botulinum Toxin Type A|
548052|NCT00850460|B3|Baseline|Total|Total of all reporting groups
548053|NCT00850460|B2|Baseline|Statins|"Statin medications
Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
548054|NCT00850460|B1|Baseline|Placebo|"Lactose placebo pill
Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
548055|NCT00850460|P2|Participant Flow|Statins|"Statin medications
Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
548056|NCT00850460|P1|Participant Flow|Placebo|"Lactose placebo pill
Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
548057|NCT00850460|O2|Outcome|Statins|"Statin medications
Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
548058|NCT00850460|O1|Outcome|Placebo|"Lactose placebo pill
Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
548059|NCT00850460|O2|Outcome|Statins|"Statin medications
Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
548060|NCT00850460|O1|Outcome|Placebo|"Lactose placebo pill
Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
548061|NCT00850460|E2|Reported Event|Statins|"Statin medications
Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
548062|NCT00850460|E1|Reported Event|Placebo|"Lactose placebo pill
Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
548063|NCT00850499|B3|Baseline|Total|Total of all reporting groups
548064|NCT00850499|B2|Baseline|Rituximab + Fludarabine|
548065|NCT00850499|B1|Baseline|Velcade + Fludarabine|
548066|NCT00850499|P2|Participant Flow|Rituximab + Fludarabine|
548067|NCT00850499|P1|Participant Flow|Velcade + Fludarabine|
548068|NCT00850499|O2|Outcome|Rituximab + Fludarabine|Rituximab + Fludarabine
548069|NCT00850499|O1|Outcome|Velcade + Fludarabine|Velcade + Fludarabine
548070|NCT00850499|O2|Outcome|Rituximab + Fludarabine|Rituximab + Fludarabine
548071|NCT00850499|O1|Outcome|Velcade + Fludarabine|Velcade + Fludarabine
548072|NCT00850499|E2|Reported Event|Rituximab + Fludarabine|
548073|NCT00850499|E1|Reported Event|Velcade + Fludarabine|
548074|NCT00850538|B1|Baseline|Enrolled|"Subjects having primary knee replacement surgery
Exclusion Criteria:
having a revision knee replacement instead of a primary knee replacement
contraindicated for MRI or CT scans
allergy to the contrast agent gadolinium
pregnant women"
548131|NCT00850759|E4|Reported Event|No-contact Control|no-contact control group.
548877|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
548075|NCT00850538|P1|Participant Flow|Enrolled|"Inclusion Criteria:
- subjects having primary knee replacement surgery
Exclusion Criteria:
having a revision knee replacement instead of a primary knee replacement
contraindicated for MRI or CT scans
allergy to the contrast agent gadolinium
pregnant women"
548076|NCT00850538|O1|Outcome|Specimens|Viable specimens for genetic analysis
548077|NCT00850538|E1|Reported Event|Enrolled|subjects having primary knee replacement surgery
548078|NCT00850564|B1|Baseline|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
548079|NCT00850564|P1|Participant Flow|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
548080|NCT00850564|O1|Outcome|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
548081|NCT00850564|O1|Outcome|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
548082|NCT00850564|E1|Reported Event|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
548083|NCT00850603|B6|Baseline|Total|Total of all reporting groups
548084|NCT00850603|B5|Baseline|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
548085|NCT00850603|B4|Baseline|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
548086|NCT00850603|B3|Baseline|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
548087|NCT00850603|B2|Baseline|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
548088|NCT00850603|B1|Baseline|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
548089|NCT00850603|P5|Participant Flow|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
548090|NCT00850603|P4|Participant Flow|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
548091|NCT00850603|P3|Participant Flow|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
548092|NCT00850603|P2|Participant Flow|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
548093|NCT00850603|P1|Participant Flow|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
548094|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
548095|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
548096|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
548097|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
548098|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
548099|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
548100|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
548101|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
548102|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
548103|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
548104|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
548105|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
548106|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
548107|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
548108|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
548109|NCT00850603|E5|Reported Event|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
548110|NCT00850603|E4|Reported Event|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
548111|NCT00850603|E3|Reported Event|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
548112|NCT00850603|E2|Reported Event|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
548113|NCT00850603|E1|Reported Event|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
548114|NCT00850720|B1|Baseline|Cardiac Surgery|Infants with congenital defects.
548115|NCT00850720|P1|Participant Flow|Cardiac Surgery|Infants with congenital defects.
548116|NCT00850720|O1|Outcome|Cardiac Surgery|Infants with congenital defects.
548117|NCT00850720|E1|Reported Event|Cardiac Surgery|Infants with congenital defects.
548118|NCT00850759|B5|Baseline|Total|Total of all reporting groups
548119|NCT00850759|B4|Baseline|No-contact Control|no-contact control group.
548120|NCT00850759|B3|Baseline|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
548121|NCT00850759|B2|Baseline|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
548122|NCT00850759|B1|Baseline|Virtual Reality|street-crossing training in a virtual pedestrian environment
548123|NCT00850759|P4|Participant Flow|No-contact Control|no-contact control group.
548124|NCT00850759|P3|Participant Flow|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
548125|NCT00850759|P2|Participant Flow|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
548126|NCT00850759|P1|Participant Flow|Virtual Reality|street-crossing training in a virtual pedestrian environment
548127|NCT00850759|O4|Outcome|No-contact Control|no-contact control group.
548128|NCT00850759|O3|Outcome|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
548129|NCT00850759|O2|Outcome|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
548132|NCT00850759|E3|Reported Event|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
548133|NCT00850759|E2|Reported Event|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
548134|NCT00850759|E1|Reported Event|Virtual Reality|street-crossing training in a virtual pedestrian environment
548135|NCT00850889|B1|Baseline|Total Participants|Each participant received Juvederm on one side of the face and Restylane on the other side.
548136|NCT00850889|P1|Participant Flow|Total Participants|Each participant received Juvederm on one side of the face and Restylane on the other side.
548137|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
548138|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
548139|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
548140|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
548141|NCT00850889|O1|Outcome|Total Study Participants|
548142|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
548143|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
548144|NCT00850889|E2|Reported Event|Restylane|
548145|NCT00850889|E1|Reported Event|Juvederm Ultra Injectable Gel With Lidocaine|
548146|NCT00850993|B5|Baseline|Total|Total of all reporting groups
548147|NCT00850993|B4|Baseline|Stanate® 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548148|NCT00850993|B3|Baseline|Stanate® 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548149|NCT00850993|B2|Baseline|Stanate® 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548150|NCT00850993|B1|Baseline|Placebo|Saline : Normal saline (0.9%) solution
548151|NCT00850993|P4|Participant Flow|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548152|NCT00850993|P3|Participant Flow|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548153|NCT00850993|P2|Participant Flow|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548154|NCT00850993|P1|Participant Flow|Placebo|Saline : Normal saline (0.9%) solution
548155|NCT00850993|O4|Outcome|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548156|NCT00850993|O3|Outcome|Stannsoporfin3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548157|NCT00850993|O2|Outcome|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548158|NCT00850993|O1|Outcome|Placebo|Saline : Normal saline (0.9%) solution
548159|NCT00850993|O4|Outcome|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548160|NCT00850993|O3|Outcome|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548161|NCT00850993|O2|Outcome|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548162|NCT00850993|O1|Outcome|Placebo|Saline : Normal saline (0.9%) solution
548163|NCT00850993|E4|Reported Event|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548164|NCT00850993|E3|Reported Event|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548165|NCT00850993|E2|Reported Event|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
548166|NCT00850993|E1|Reported Event|Placebo|Saline : Normal saline (0.9%) solution
548167|NCT00851006|B1|Baseline|Open Label Creatine Treatment|Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks. Inclusion criteria were: females 13–18 years of age with a primary diagnosis of MDD. All participants were Caucasian females.
548168|NCT00851006|P2|Participant Flow|Healthy Control Group|Only 31P MRS brain scans were used from healthy individuals. HC group were not treated.
548169|NCT00851006|P1|Participant Flow|Open Label Creatine Treatment|Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks.
548170|NCT00851006|O2|Outcome|Healthy Control Group|6 healthy controls returned 8 weeks later for a follow-up scan. HC group did not receive any treatment.
548171|NCT00851006|O1|Outcome|Open Label Creatine Treatment|"MDD participants' 31P MRS scans were performed prior to the first dose of creatine, and repeated following 8 weeks of treatment.
Participants were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks."
548172|NCT00851006|O1|Outcome|Open Label Creatine Treatment|The seven subjects who completed the protocol received creatine in the 1-8 week interval. Creatine was initiated at week 0 and terminated at week 8.
548173|NCT00851006|E2|Reported Event|Healthy Control Group|Healthy Control Group did not go through treatment. HC 31P MRS scans were only used for the study.
548174|NCT00851006|E1|Reported Event|Open Label Creatine Treatment|There were no serious adverse events were experienced in this study.
548175|NCT00851084|B3|Baseline|Total|Total of all reporting groups
548176|NCT00851084|B2|Baseline|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
548177|NCT00851084|B1|Baseline|mFOLFOX6 Only|modified FOLFOX6
548178|NCT00851084|P2|Participant Flow|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
548179|NCT00851084|P1|Participant Flow|mFOLFOX6 Only|modified FOLFOX6
548180|NCT00851084|O2|Outcome|Positive|Positive antidrug antibody (ADA) assay status at Baseline for those participants treated with aflibercept.
548181|NCT00851084|O1|Outcome|Negative or Missing|Negative or missing antidrug antibody (ADA) assay status at Baseline for those participants treated with aflibercept.
548182|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
548183|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
548184|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
548185|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
548186|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
548187|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
548188|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
548189|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
548190|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
548191|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
548192|NCT00851084|E2|Reported Event|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
548193|NCT00851084|E1|Reported Event|mFOLFOX6 Only|modified FOLFOX6
548194|NCT00851279|B1|Baseline|Magnetic Irrigated Ablation Catheter|Patients underwent ablation therapy using remote magnetic navigation, RMN (Niobe, Stereotaxis Inc.,St Louis, USA), and an irrigated RF ablation catheter (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
548195|NCT00851279|P1|Participant Flow|Magnetic Irrigated Ablation Catheter|Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system
548196|NCT00851279|O1|Outcome|Magnetic Irrigated Ablation Catheter|Either the transseptal or transaortic approach was employed to gain access for endocardial mapping/ablation during VT (entrainment mapping, activation mapping) and/or substrate mapping in sinus rhythm (elimination of fractionated/late potentials, endocardial scar homogenization) with RMN (Niobe, Stereotaxis Inc.,St Louis, USA) and irrigated RF ablation (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
548197|NCT00851279|E1|Reported Event|Magnetic Irrigated Ablation Catheter|"Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system
There were no adverse events associated with the procedure and within a 7 to 10 days post-doc window"
548198|NCT00851318|B5|Baseline|Total|Total of all reporting groups
548199|NCT00851318|B4|Baseline|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548200|NCT00851318|B3|Baseline|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548201|NCT00851318|B2|Baseline|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548202|NCT00851318|B1|Baseline|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548203|NCT00851318|P4|Participant Flow|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548204|NCT00851318|P3|Participant Flow|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548878|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
548879|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
548205|NCT00851318|P2|Participant Flow|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548206|NCT00851318|P1|Participant Flow|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548207|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548208|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548209|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548210|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548211|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548212|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548213|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548214|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548215|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548216|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548217|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548218|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548219|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548220|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548221|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548222|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548223|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548224|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548225|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548880|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
548226|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548227|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548228|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548229|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548230|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548231|NCT00851318|E4|Reported Event|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548232|NCT00851318|E3|Reported Event|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548233|NCT00851318|E2|Reported Event|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548234|NCT00851318|E1|Reported Event|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
548235|NCT00851409|B1|Baseline|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor
Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
548236|NCT00851409|P1|Participant Flow|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor
Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
548237|NCT00851409|O1|Outcome|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor
Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
548238|NCT00851409|O1|Outcome|Recombinant Human C1 Inhibitor|"Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
548239|NCT00851409|E1|Reported Event|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor
Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
548240|NCT00851552|B1|Baseline|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
548241|NCT00851552|P1|Participant Flow|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
548242|NCT00851552|O1|Outcome|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
548243|NCT00851552|O1|Outcome|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
548244|NCT00851552|E1|Reported Event|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
548245|NCT00851591|B3|Baseline|Total|Total of all reporting groups
548246|NCT00851591|B2|Baseline|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
548247|NCT00851591|B1|Baseline|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
548248|NCT00851591|P2|Participant Flow|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
548249|NCT00851591|P1|Participant Flow|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
548250|NCT00851591|O2|Outcome|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
548251|NCT00851591|O1|Outcome|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
548252|NCT00851591|E2|Reported Event|2 Group Scheduled to Receive Placebo|Psyllium Category: These patients were scheduled to take 3 capsules 3 times a day with a full glass of water and each dose was for 7 days.
548253|NCT00851591|E1|Reported Event|1 Group Scheduled to Receive Fenugreek|Fenugreek Category: These patients were scheduled to take 3 capsules 3 times per day with a full glass of water and each dose was for 7 days.
548254|NCT00851630|B3|Baseline|Total|Total of all reporting groups
548881|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
548255|NCT00851630|B2|Baseline|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
548256|NCT00851630|B1|Baseline|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
548257|NCT00851630|P2|Participant Flow|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
548258|NCT00851630|P1|Participant Flow|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
548259|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
548260|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
548261|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
548262|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
548263|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
548264|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
548265|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
548266|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
548267|NCT00851630|E2|Reported Event|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
548268|NCT00851630|E1|Reported Event|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
548269|NCT00851643|B7|Baseline|Total|Total of all reporting groups
548270|NCT00851643|B6|Baseline|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548271|NCT00851643|B5|Baseline|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548272|NCT00851643|B4|Baseline|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548273|NCT00851643|B3|Baseline|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548274|NCT00851643|B2|Baseline|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate(AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548275|NCT00851643|B1|Baseline|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548276|NCT00851643|P6|Participant Flow|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548277|NCT00851643|P5|Participant Flow|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548278|NCT00851643|P4|Participant Flow|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548279|NCT00851643|P3|Participant Flow|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548280|NCT00851643|P2|Participant Flow|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548281|NCT00851643|P1|Participant Flow|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
548282|NCT00851643|O3|Outcome|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
548283|NCT00851643|O2|Outcome|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 60 mcg ISCOMATRIX™(IMX)
548284|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase B
548285|NCT00851643|O3|Outcome|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
548286|NCT00851643|O2|Outcome|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
548287|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
548288|NCT00851643|O3|Outcome|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
548289|NCT00851643|O2|Outcome|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 60 mcg ISCOMATRIX™(IMX)
548290|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase B
548291|NCT00851643|O3|Outcome|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
548292|NCT00851643|O2|Outcome|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
548293|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
548294|NCT00851643|E5|Reported Event|Octavalent With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 120 mcg IMX.
548295|NCT00851643|E4|Reported Event|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 60 mcg IMX.
548296|NCT00851643|E3|Reported Event|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 30 mcg IMX.
548297|NCT00851643|E2|Reported Event|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 15 mcg IMX.
548298|NCT00851643|E1|Reported Event|qHPV (GARDASIL™) - Phase A and Phase B Controls|Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) combined from Phase A and Phase B.
548299|NCT00851682|B3|Baseline|Total|Total of all reporting groups
548300|NCT00851682|B2|Baseline|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
548301|NCT00851682|B1|Baseline|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
548302|NCT00851682|P2|Participant Flow|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
548303|NCT00851682|P1|Participant Flow|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
548304|NCT00851682|O2|Outcome|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
548305|NCT00851682|O1|Outcome|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
548336|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548882|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
548883|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
548306|NCT00851682|O2|Outcome|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
548307|NCT00851682|O1|Outcome|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
548308|NCT00851682|E2|Reported Event|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
548309|NCT00851682|E1|Reported Event|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
548310|NCT00851721|B3|Baseline|Total|Total of all reporting groups
548311|NCT00851721|B2|Baseline|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548312|NCT00851721|B1|Baseline|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
548313|NCT00851721|P2|Participant Flow|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548314|NCT00851721|P1|Participant Flow|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
548315|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548316|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548317|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548318|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548319|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548320|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548321|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548322|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548323|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548324|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548325|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548326|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548327|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548328|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548329|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548330|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548331|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548332|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548333|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548334|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548335|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548337|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548338|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548339|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548340|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548341|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548342|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548343|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548344|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548345|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548346|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548347|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548348|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548349|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548350|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548351|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548352|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548353|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548354|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548355|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548356|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548357|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548358|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548359|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548360|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548361|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548362|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548363|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548364|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548365|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548366|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548367|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548368|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548369|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548370|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548371|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548372|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548373|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548374|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548375|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548376|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548377|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548378|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548379|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548380|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548381|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548382|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548383|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548384|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548385|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548386|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548387|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548388|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548389|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548390|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
548391|NCT00851721|O1|Outcome|On-demand Arm Versus Prophylaxis Arm|"On-demand arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
Prophylaxis arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period"
548392|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548393|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548394|NCT00851721|O1|Outcome|On-demand Arm Versus Prophylaxis Arm|"On-demand arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
Prophylaxis arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period"
548395|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548396|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548397|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
548398|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
548399|NCT00851721|E2|Reported Event|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month ± 14 days prophylactic period
548400|NCT00851721|E1|Reported Event|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
548401|NCT00851786|B3|Baseline|Total|Total of all reporting groups
548402|NCT00851786|B2|Baseline|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
548403|NCT00851786|B1|Baseline|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
548404|NCT00851786|P2|Participant Flow|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
548405|NCT00851786|P1|Participant Flow|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
548406|NCT00851786|O2|Outcome|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
548407|NCT00851786|O1|Outcome|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
548408|NCT00851786|O2|Outcome|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
548409|NCT00851786|O1|Outcome|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
548410|NCT00851786|E2|Reported Event|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
548411|NCT00851786|E1|Reported Event|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
548412|NCT00851799|B4|Baseline|Total|Total of all reporting groups
548413|NCT00851799|B3|Baseline|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548414|NCT00851799|B2|Baseline|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548415|NCT00851799|B1|Baseline|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548416|NCT00851799|P3|Participant Flow|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548417|NCT00851799|P2|Participant Flow|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548418|NCT00851799|P1|Participant Flow|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548419|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548420|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548421|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548422|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548423|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548424|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548804|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548805|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548806|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548425|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548426|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548427|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548428|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548429|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548430|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548431|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548432|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548433|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548434|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548435|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548436|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548437|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548438|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548439|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548440|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548441|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548442|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548443|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548444|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548445|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548807|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548808|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548446|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548447|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548448|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548449|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548450|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548451|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548452|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548453|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548454|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548455|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548456|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548457|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548458|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548459|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548460|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548461|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548462|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548463|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548464|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548465|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548466|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548809|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548810|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548467|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548468|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548469|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548470|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548471|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548472|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548473|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548474|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548475|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548476|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548477|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548478|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548479|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548480|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548481|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548482|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548483|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548484|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548485|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548486|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548487|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548811|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548812|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548488|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548489|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548490|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548491|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548492|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548493|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548494|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548495|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548496|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548497|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548498|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548499|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548500|NCT00851799|E3|Reported Event|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
548501|NCT00851799|E2|Reported Event|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
548502|NCT00851799|E1|Reported Event|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
548503|NCT00851890|B5|Baseline|Total|Total of all reporting groups
548504|NCT00851890|B4|Baseline|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548505|NCT00851890|B3|Baseline|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548506|NCT00851890|B2|Baseline|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548507|NCT00851890|B1|Baseline|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548508|NCT00851890|P4|Participant Flow|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548813|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548509|NCT00851890|P3|Participant Flow|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548510|NCT00851890|P2|Participant Flow|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548511|NCT00851890|P1|Participant Flow|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548512|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548513|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548514|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548515|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548516|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548517|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548518|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548519|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548520|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548521|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548522|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548523|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548524|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548525|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548526|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548814|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548527|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548528|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548529|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548530|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548531|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548532|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548533|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548534|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548535|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548536|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548537|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548538|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548539|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548540|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548541|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548542|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548543|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548544|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548815|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548545|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548546|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548547|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548548|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548549|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548550|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548551|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548552|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548553|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548554|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548555|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548556|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548557|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548558|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548559|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548560|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548561|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548562|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
548816|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548563|NCT00851890|E4|Reported Event|Placebo + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
548564|NCT00851890|E3|Reported Event|ABT-333 (1200 mg) Once Daily (QD) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
548565|NCT00851890|E2|Reported Event|ABT-333 (600 mg) Twice Daily (BID) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
548566|NCT00851890|E1|Reported Event|ABT-333 (300 mg) Twice Daily (BID) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
548567|NCT00851903|B1|Baseline|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).
Sitagliptin: stable dose of 100 mg once a day administered with or without food."
548568|NCT00851903|P1|Participant Flow|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).
Sitagliptin: stable dose of 100 mg once a day administered with or without food."
548569|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).
Sitagliptin: stable dose of 100 mg once a day administered with or without food."
548570|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).
Sitagliptin: stable dose of 100 mg once a day administered with or without food."
548571|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).
Sitagliptin: stable dose of 100 mg once a day administered with or without food."
548572|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).
Sitagliptin: stable dose of 100 mg once a day administered with or without food."
548573|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).
Sitagliptin: stable dose of 100 mg once a day administered with or without food."
548574|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).
Sitagliptin: stable dose of 100 mg once a day administered with or without food."
548817|NCT00839241|E2|Reported Event|Allogenic Blood Transfusion|
548818|NCT00839241|E1|Reported Event|Autologous Blood Transfusion|
548575|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).
Sitagliptin: stable dose of 100 mg once a day administered with or without food."
548576|NCT00851903|E1|Reported Event|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).
Sitagliptin: stable dose of 100 mg once a day administered with or without food."
548577|NCT00838682|B3|Baseline|Total|Total of all reporting groups
548578|NCT00838682|B2|Baseline|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548579|NCT00838682|B1|Baseline|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548580|NCT00838682|P2|Participant Flow|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548581|NCT00838682|P1|Participant Flow|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548582|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548583|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548584|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548585|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548586|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548587|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548588|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548589|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548590|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548591|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548592|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548593|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548594|NCT00838682|E2|Reported Event|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548595|NCT00838682|E1|Reported Event|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
548596|NCT00838903|B5|Baseline|Total|Total of all reporting groups
548597|NCT00838903|B4|Baseline|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548598|NCT00838903|B3|Baseline|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548599|NCT00838903|B2|Baseline|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548600|NCT00838903|B1|Baseline|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548819|NCT00839306|B3|Baseline|Total|Total of all reporting groups
548884|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
557834|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
548601|NCT00838903|P4|Participant Flow|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548602|NCT00838903|P3|Participant Flow|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548603|NCT00838903|P2|Participant Flow|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548604|NCT00838903|P1|Participant Flow|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548605|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548606|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548607|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548608|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548609|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548610|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548611|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548612|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548613|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548614|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548615|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548616|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548617|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548618|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548619|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548620|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548621|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548622|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548623|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548624|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548625|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548626|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548627|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548628|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548629|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548630|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548631|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548632|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548633|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548634|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548635|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548636|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548885|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
548637|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548638|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548639|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548640|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548641|NCT00838903|E4|Reported Event|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548642|NCT00838903|E3|Reported Event|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548643|NCT00838903|E2|Reported Event|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548644|NCT00838903|E1|Reported Event|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548645|NCT00838916|B3|Baseline|Total|Total of all reporting groups
548646|NCT00838916|B2|Baseline|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548647|NCT00838916|B1|Baseline|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548648|NCT00838916|P2|Participant Flow|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548649|NCT00838916|P1|Participant Flow|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548650|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548651|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548652|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548653|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548654|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548886|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
548887|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
548655|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548656|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548657|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548658|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548659|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548660|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548661|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548662|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548663|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548664|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548665|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548666|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548667|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548668|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548669|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548670|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548671|NCT00838916|E2|Reported Event|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548888|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
548672|NCT00838916|E1|Reported Event|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
548673|NCT00838929|B4|Baseline|Total|Total of all reporting groups
548674|NCT00838929|B3|Baseline|Vorinostat (400 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.
Vorinostat : All doses given for 3 weeks
Dose level III - 400 mg PO qd
Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
548675|NCT00838929|B2|Baseline|Vorinostat (300 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.
Vorinostat : All doses given for 3 weeks
Dose level II - 300 mg PO qd
Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
548676|NCT00838929|B1|Baseline|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.
Vorinostat : All doses given for 3 weeks
Dose level I - 200 mg PO qd (initial starting dose)
Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
548677|NCT00838929|P3|Participant Flow|Vorinostat (400 mg) and Radiation|
548678|NCT00838929|P2|Participant Flow|Vorinostat (300 mg) and Radiation|
548679|NCT00838929|P1|Participant Flow|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.
Vorinostat : All doses given for 3 weeks
Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd
Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
548680|NCT00838929|O1|Outcome|Vorinostat and Radiation - All Participants|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.
Vorinostat : All doses given for 3 weeks
Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd
Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
548681|NCT00838929|E3|Reported Event|Vorinostat (400 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.
Vorinostat : All doses given for 3 weeks
Dose level III - 400 mg PO qd
Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
548682|NCT00838929|E2|Reported Event|Vorinostat (300 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.
Vorinostat : All doses given for 3 weeks
Dose level II - 300 mg PO qd
Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
548683|NCT00838929|E1|Reported Event|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.
Vorinostat : All doses given for 3 weeks
Dose level I - 200 mg PO qd (initial starting dose)
Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
548684|NCT00839072|B1|Baseline|Entire Study Population|Includes groups randomized to receive Test first and Reference first.
548685|NCT00839072|P2|Participant Flow|Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First|"1 * 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone Contramid® OAD (Once-A-Day) 300 mg Tablet Daily test product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.
IR = Immediate Release."
548686|NCT00839072|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"1 * 300 mg Trazodone Contramid® OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Trazodone IR (Desyrel®) 100 mg tablet 8-hourly reference product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.
IR = Immediate Release."
548687|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548688|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548689|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548690|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548691|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548692|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548693|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548694|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548695|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548696|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548697|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548698|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548699|NCT00839072|E2|Reported Event|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548700|NCT00839072|E1|Reported Event|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.
OAD = Once A Day"
548701|NCT00839098|B4|Baseline|Total|Total of all reporting groups
548702|NCT00839098|B3|Baseline|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group
Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
548703|NCT00839098|B2|Baseline|Instruction Group|"Instruction Group
Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
548704|NCT00839098|B1|Baseline|Control Group|Control Group
548820|NCT00839306|B2|Baseline|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
548821|NCT00839306|B1|Baseline|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
548822|NCT00839306|P2|Participant Flow|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
548705|NCT00839098|P3|Participant Flow|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group
Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
548706|NCT00839098|P2|Participant Flow|Instruction Group|"Instruction Group
Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
548707|NCT00839098|P1|Participant Flow|Control Group|Control Group
548708|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
548709|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
548710|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
548711|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
548712|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
548713|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
548714|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
548715|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
548716|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
548717|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
548718|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
548719|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
548720|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
548721|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
548722|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
548723|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
548724|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
548725|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
548726|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
548727|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
548728|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
548823|NCT00839306|P1|Participant Flow|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
548824|NCT00839306|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
548825|NCT00839306|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
548729|NCT00839098|E3|Reported Event|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group
Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
548730|NCT00839098|E2|Reported Event|Instruction Group|"Instruction Group
Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
548731|NCT00839098|E1|Reported Event|Control Group|Control Group
548732|NCT00839241|B3|Baseline|Total|Total of all reporting groups
548733|NCT00839241|B2|Baseline|Allogenic Blood Transfusion|
548734|NCT00839241|B1|Baseline|Autologous Blood Transfusion|
548735|NCT00839241|P2|Participant Flow|Allogenic Blood Transfusion|
548736|NCT00839241|P1|Participant Flow|Autologous Blood Transfusion|
548737|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548738|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548739|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548740|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548741|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548742|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548743|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548744|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548745|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548746|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548747|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548748|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548749|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548750|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548751|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548752|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548753|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548754|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548755|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548756|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548757|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548758|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548759|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548760|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548761|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548762|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548763|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548764|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548765|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548766|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548767|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548768|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548769|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548770|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548771|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548772|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548773|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548774|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548775|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548776|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548777|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548778|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548779|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548780|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548781|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548782|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548783|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548784|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548785|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548786|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548787|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548788|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548789|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548790|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548791|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548792|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548793|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548794|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548795|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548796|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548797|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548798|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548799|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548800|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548801|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548802|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
548803|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
548826|NCT00839306|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose inlcuded 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
548827|NCT00839306|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
548828|NCT00839306|E2|Reported Event|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
548829|NCT00839306|E1|Reported Event|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
548830|NCT00839319|B6|Baseline|Total|Total of all reporting groups
548831|NCT00839319|B5|Baseline|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
548832|NCT00839319|B4|Baseline|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
548833|NCT00839319|B3|Baseline|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
548834|NCT00839319|B2|Baseline|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
548835|NCT00839319|B1|Baseline|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
548836|NCT00839319|P5|Participant Flow|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
548837|NCT00839319|P4|Participant Flow|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
548838|NCT00839319|P3|Participant Flow|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
548839|NCT00839319|P2|Participant Flow|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
548840|NCT00839319|P1|Participant Flow|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
548841|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
548842|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
548843|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
548844|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
548845|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
548846|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
548847|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
548848|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
548849|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
548850|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
548851|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
548852|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
548853|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
548854|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
548855|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
548856|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
548857|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
548858|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
548859|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
548860|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
548861|NCT00839319|E5|Reported Event|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
548862|NCT00839319|E4|Reported Event|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
548863|NCT00839319|E3|Reported Event|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
548864|NCT00839319|E2|Reported Event|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
548865|NCT00839319|E1|Reported Event|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
548866|NCT00839423|B5|Baseline|Total|Total of all reporting groups
548867|NCT00839423|B4|Baseline|Venlafaxine 225 mg|capsules, daily, orally
548868|NCT00839423|B3|Baseline|Vortioxetine 10 mg|encapsulated tablets, daily, orally
548869|NCT00839423|B2|Baseline|Vortioxetine 5 mg|encapsulated tablets, daily, orally
548870|NCT00839423|B1|Baseline|Placebo|capsules, daily, orally
548871|NCT00839423|P4|Participant Flow|Venlafaxine 225 mg|capsules, daily, orally
548872|NCT00839423|P3|Participant Flow|Vortioxetine 10 mg|encapsulated tablets, daily, orally
548873|NCT00839423|P2|Participant Flow|Vortioxetine 5 mg|encapsulated tablets, daily, orally
548874|NCT00839423|P1|Participant Flow|Placebo|capsules, daily, orally
548875|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
548889|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
548890|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
548891|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
548892|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
548893|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
548894|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
548895|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
548896|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
548897|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
548898|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
548899|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
548900|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
548901|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
548902|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
548903|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
548904|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
548905|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
548906|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
548907|NCT00839423|E4|Reported Event|Venlafaxine 225 mg|
548908|NCT00839423|E3|Reported Event|Vortioxetine 10 mg|
548909|NCT00839423|E2|Reported Event|Vortioxetine 5 mg|
548910|NCT00839423|E1|Reported Event|Placebo|
548911|NCT00839436|B4|Baseline|Total|Total of all reporting groups
548912|NCT00839436|B3|Baseline|20 mcg/kg Cohort|
548913|NCT00839436|B2|Baseline|10 mcg/kg Cohort|
548914|NCT00839436|B1|Baseline|3 mcg/kg Cohort|
548915|NCT00839436|P3|Participant Flow|20 mcg/kg Cohort|
548916|NCT00839436|P2|Participant Flow|10 mcg/kg Cohort|
548917|NCT00839436|P1|Participant Flow|3 mcg/kg Cohort|
548918|NCT00839436|O3|Outcome|20 mcg/kg Cohort|
548919|NCT00839436|O2|Outcome|10 mcg/kg Cohort|
548920|NCT00839436|O1|Outcome|3 mcg/kg Cohort|
548921|NCT00839436|E3|Reported Event|20 mcg/kg Cohort|
548922|NCT00839436|E2|Reported Event|10 mcg/kg Cohort|
548923|NCT00839436|E1|Reported Event|3 mcg/kg Cohort|
548924|NCT00839527|B4|Baseline|Total|Total of all reporting groups
548925|NCT00839527|B3|Baseline|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548926|NCT00839527|B2|Baseline|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548927|NCT00839527|B1|Baseline|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548928|NCT00839527|P3|Participant Flow|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548929|NCT00839527|P2|Participant Flow|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548930|NCT00839527|P1|Participant Flow|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548931|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548932|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548933|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548934|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548935|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548936|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548937|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548938|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548939|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548940|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548941|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548942|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548943|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548944|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548945|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548946|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548947|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548948|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548949|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548950|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548951|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548982|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548952|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548953|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548954|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548955|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548956|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548957|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548958|NCT00839527|E3|Reported Event|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548959|NCT00839527|E2|Reported Event|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548960|NCT00839527|E1|Reported Event|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
548961|NCT00839540|B4|Baseline|Total|Total of all reporting groups
548962|NCT00839540|B3|Baseline|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
548963|NCT00839540|B2|Baseline|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
548964|NCT00839540|B1|Baseline|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
548965|NCT00839540|P3|Participant Flow|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
548966|NCT00839540|P2|Participant Flow|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
548967|NCT00839540|P1|Participant Flow|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
548968|NCT00839540|O3|Outcome|Log Inhibition of 200 mg/Day Micafungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 200 mg/day dosing, measured as Ex-vivo effect.
548969|NCT00839540|O2|Outcome|Log Inhibition of 100 mg/Day Micafungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 100 mg/day dosing, measured as Ex-vivo effect.
548970|NCT00839540|O1|Outcome|Log Inhibition of 50 mg/Day Caspofungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Caspofungin based on 50 mg/day dosing, measured as Ex-vivo effect.
548971|NCT00839540|E3|Reported Event|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
548972|NCT00839540|E2|Reported Event|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
548973|NCT00839540|E1|Reported Event|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
548974|NCT00839800|B3|Baseline|Total|Total of all reporting groups
548975|NCT00839800|B2|Baseline|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
548976|NCT00839800|B1|Baseline|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548977|NCT00839800|P2|Participant Flow|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
548978|NCT00839800|P1|Participant Flow|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548979|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
548980|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548981|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
549036|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
548983|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
548984|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548985|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
548986|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548987|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
548988|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548989|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
548990|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548991|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
548992|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548993|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
548994|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548995|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
548996|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548997|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
548998|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
548999|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
549000|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
549001|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
549002|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
549003|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
549004|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
549005|NCT00839800|E2|Reported Event|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
549006|NCT00839800|E1|Reported Event|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
549007|NCT00839917|B3|Baseline|Total|Total of all reporting groups
549008|NCT00839917|B2|Baseline|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549009|NCT00839917|B1|Baseline|ProQuad™|Single subcutaneous 0.5 mL vaccination
549010|NCT00839917|P2|Participant Flow|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549011|NCT00839917|P1|Participant Flow|ProQuad™|Single subcutaneous 0.5 mL vaccination
549012|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549013|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549014|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549015|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549016|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549017|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549018|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549019|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549020|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549021|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549022|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549023|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549024|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549025|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549026|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549027|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549028|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549029|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549030|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549031|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549032|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549033|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549034|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549035|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
557835|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
549037|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549038|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549039|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549040|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549041|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549042|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549043|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
549044|NCT00839917|E2|Reported Event|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
549045|NCT00839917|E1|Reported Event|ProQuad™|Single subcutaneous 0.5 mL vaccination
549046|NCT00839930|B3|Baseline|Total|Total of all reporting groups
549047|NCT00839930|B2|Baseline|Pletal® (Reference) First|Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period
549048|NCT00839930|B1|Baseline|Cilostazol (Test) First|Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period
549049|NCT00839930|P2|Participant Flow|Pletal® (Reference) First|Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period
549050|NCT00839930|P1|Participant Flow|Cilostazol (Test) First|Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period
549051|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
549052|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
549053|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
549054|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
549055|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
549056|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
549057|NCT00839956|B1|Baseline|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Vorinostat: Given PO"
549058|NCT00839956|P1|Participant Flow|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Vorinostat: Given PO"
549059|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Vorinostat: Given PO"
549060|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Vorinostat: Given PO"
549061|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Vorinostat: Given PO"
549062|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Vorinostat: Given PO"
549063|NCT00839956|E1|Reported Event|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given IV
Vorinostat: Given PO"
549064|NCT00839982|B1|Baseline|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549065|NCT00839982|P4|Participant Flow|Dose Level 4|"Patients receive clofarabine 30mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549066|NCT00839982|P3|Participant Flow|Dose Level 3|"Patients receive clofarabine 25mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549067|NCT00839982|P2|Participant Flow|Dose Level 2|"Patients receive clofarabine 20mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549068|NCT00839982|P1|Participant Flow|Dose Level 1|"Patients receive clofarabine 10mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549069|NCT00839982|O1|Outcome|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549070|NCT00839982|O1|Outcome|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549071|NCT00839982|O4|Outcome|Dose Level 4|"Patients receive clofarabine 30 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549105|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
549072|NCT00839982|O3|Outcome|Dose Level 3|"Patients receive clofarabine 25 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549073|NCT00839982|O2|Outcome|Dose Level 2|"Patients receive clofarabine 20 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549074|NCT00839982|O1|Outcome|Dose Level 1|"Patients receive clofarabine 10 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549075|NCT00839982|O1|Outcome|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549076|NCT00839982|O4|Outcome|Dose Level 4|"Patients receive clofarabine 30 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549077|NCT00839982|O3|Outcome|Dose Level 3|"Patients receive clofarabine 25 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549078|NCT00839982|O2|Outcome|Dose Level 2|"Patients receive clofarabine 20 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549079|NCT00839982|O1|Outcome|Dose Level 1|"Patients receive clofarabine 10 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO
cytarabine: Given SC"
549080|NCT00839982|E1|Reported Event|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
clofarabine: Given PO cytarabine: Given SC"
549081|NCT00840060|B3|Baseline|Total|Total of all reporting groups
549082|NCT00840060|B2|Baseline|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
549083|NCT00840060|B1|Baseline|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
549084|NCT00840060|P2|Participant Flow|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
549085|NCT00840060|P1|Participant Flow|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
549086|NCT00840060|O2|Outcome|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
549087|NCT00840060|O1|Outcome|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
549088|NCT00840060|O2|Outcome|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
549089|NCT00840060|O1|Outcome|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
549090|NCT00840060|E2|Reported Event|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
549091|NCT00840060|E1|Reported Event|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
549092|NCT00840073|B3|Baseline|Total|Total of all reporting groups
549093|NCT00840073|B2|Baseline|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
549094|NCT00840073|B1|Baseline|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
549095|NCT00840073|P2|Participant Flow|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
549096|NCT00840073|P1|Participant Flow|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
549097|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
549098|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
549099|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
549100|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
549101|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
549102|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
549103|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
549104|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
549106|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
549107|NCT00840086|B1|Baseline|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
549108|NCT00840086|P1|Participant Flow|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
549109|NCT00840086|O3|Outcome|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
549110|NCT00840086|O2|Outcome|Part C|Surgery sub-trial: This part of the trial included any of the patients from Part A and Part B that during the course of the trial needed to undergo a major or minor surgical procedure requiring at least 7 days of daily FVIII treatment, including the day of surgery. Patients received a preoperative loading dose of turoctocog alfa immediately prior to the surgical procedure. On the day of surgery and until Day 7 (included) turoctocog alfa was dose adjusted aiming for a trough level above 0.50 IU/mL. Day 8 to last day of the surgical recovery period (if relevant) turoctocog alfa was dosed according to local guidelines.
549111|NCT00840086|O1|Outcome|Total (Part A + Part B)|Preventive treatment and treatment of bleeds: The doses were individualised based on the trough FVIII activity level. The doses could be adjusted by the investigator. The dose level chosen was 20-40 IU/kg every second day or 20-50 IU/kg three times per week (Part A + Part B). Subjects previously treated with turoctocog alpha were included in Part A.
549112|NCT00840086|O1|Outcome|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
549113|NCT00840086|E1|Reported Event|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
549114|NCT00840099|B3|Baseline|Total|Total of all reporting groups
549115|NCT00840099|B2|Baseline|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
549116|NCT00840099|B1|Baseline|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
549117|NCT00840099|P2|Participant Flow|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
549118|NCT00840099|P1|Participant Flow|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
549119|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
549120|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
549121|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
549122|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
549123|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
549124|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
549125|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
549126|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
549127|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
549128|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
549129|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
549130|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
549131|NCT00840203|B3|Baseline|Total|Total of all reporting groups
549132|NCT00840203|B2|Baseline|Rowasa® (Reference) First|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
549133|NCT00840203|B1|Baseline|Mesalamine (Test) First|Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
549134|NCT00840203|P2|Participant Flow|Rowasa® (Reference) First|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
549135|NCT00840203|P1|Participant Flow|Mesalamine (Test) First|Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
549136|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
549137|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
549138|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
549139|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
549140|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
549141|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
549142|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
549143|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
549144|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
549145|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
549146|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
549147|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
549148|NCT00840216|B3|Baseline|Total|Total of all reporting groups
549149|NCT00840216|B2|Baseline|Biaxin® (Reference) First|Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
549150|NCT00840216|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
549151|NCT00840216|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
549152|NCT00840216|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
549153|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
549154|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
549155|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
549156|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
549157|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
549158|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
549159|NCT00840281|B3|Baseline|Total|Total of all reporting groups
549160|NCT00840281|B2|Baseline|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
549161|NCT00840281|B1|Baseline|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
549162|NCT00840281|P2|Participant Flow|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
549163|NCT00840281|P1|Participant Flow|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
549164|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
549165|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
549166|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
549167|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
549168|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
549169|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
549170|NCT00840294|B3|Baseline|Total|Total of all reporting groups
549171|NCT00840294|B2|Baseline|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
549172|NCT00840294|B1|Baseline|Observation|Observation only for 2 weeks
549173|NCT00840294|P2|Participant Flow|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
549174|NCT00840294|P1|Participant Flow|Observation|Observation only for 2 weeks
549175|NCT00840294|O2|Outcome|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
549176|NCT00840294|O1|Outcome|Observation|Observation only for 2 weeks
549177|NCT00840294|O2|Outcome|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
549178|NCT00840294|O1|Outcome|Observation|Observation only for 2 weeks
549179|NCT00840294|E2|Reported Event|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
549180|NCT00840294|E1|Reported Event|Observation|Observation only for 2 weeks
549181|NCT00840411|B3|Baseline|Total|Total of all reporting groups
549182|NCT00840411|B2|Baseline|Biaxin® XL (Reference) First|Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
549183|NCT00840411|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.
549184|NCT00840411|P2|Participant Flow|Biaxin® XL (Reference) First|Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
549185|NCT00840411|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.
549186|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
549187|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
549188|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
549189|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
549190|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
549191|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
549192|NCT00840450|B1|Baseline|Paclitaxel and Imatinib Mesylate (Gleevec)|
549193|NCT00840450|P1|Participant Flow|Paclitaxel and Imatinib Mesylate (Gleevec)|
549194|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
549195|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
549196|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
549197|NCT00840450|E1|Reported Event|Paclitaxel and Imatinib Mesylate (Gleevec)|
549198|NCT00840476|B3|Baseline|Total|Total of all reporting groups
549199|NCT00840476|B2|Baseline|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
549200|NCT00840476|B1|Baseline|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
549573|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
549201|NCT00840476|P2|Participant Flow|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
549202|NCT00840476|P1|Participant Flow|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
549203|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
549204|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
549205|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
549206|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
549207|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
549208|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
549209|NCT00845845|B3|Baseline|Total|Total of all reporting groups
549210|NCT00845845|B2|Baseline|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
549211|NCT00845845|B1|Baseline|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
549212|NCT00845845|P2|Participant Flow|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
549213|NCT00845845|P1|Participant Flow|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
549214|NCT00845845|O2|Outcome|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
549215|NCT00845845|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
549216|NCT00845845|O2|Outcome|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
549217|NCT00845845|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
549218|NCT00845845|E2|Reported Event|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
549219|NCT00845845|E1|Reported Event|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
549220|NCT00845858|B4|Baseline|Total|Total of all reporting groups
549221|NCT00845858|B3|Baseline|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
549222|NCT00845858|B2|Baseline|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
549223|NCT00845858|B1|Baseline|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
549224|NCT00845858|P3|Participant Flow|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
549225|NCT00845858|P2|Participant Flow|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
549226|NCT00845858|P1|Participant Flow|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
549227|NCT00845858|O3|Outcome|Female-Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
549228|NCT00845858|O2|Outcome|Female-Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
549229|NCT00845858|O1|Outcome|Female-Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
549230|NCT00845858|O3|Outcome|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
549231|NCT00845858|O2|Outcome|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
549232|NCT00845858|O1|Outcome|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
549233|NCT00845858|E3|Reported Event|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
549234|NCT00845858|E2|Reported Event|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
549235|NCT00845858|E1|Reported Event|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
549236|NCT00845897|B4|Baseline|Total|Total of all reporting groups
549237|NCT00845897|B3|Baseline|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
549238|NCT00845897|B2|Baseline|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
549239|NCT00845897|B1|Baseline|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
549240|NCT00845897|P3|Participant Flow|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
549241|NCT00845897|P2|Participant Flow|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
549242|NCT00845897|P1|Participant Flow|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
549243|NCT00845897|O3|Outcome|Botulinum Toxin 300 Units|300 units of Botox®
549244|NCT00845897|O2|Outcome|Placebo|Saline
549245|NCT00845897|O1|Outcome|Botulinum Toxin 200 Units|200 units of Botox®
549246|NCT00845897|O3|Outcome|Botulinum Toxin 300 Units|300 units of Botox®
549247|NCT00845897|O2|Outcome|Placebo|Saline
549248|NCT00845897|O1|Outcome|Botulinum Toxin 200 Units|200 units of Botox®
549249|NCT00845897|E3|Reported Event|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
549250|NCT00845897|E2|Reported Event|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
549251|NCT00845897|E1|Reported Event|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
549252|NCT00852124|B3|Baseline|Total|Total of all reporting groups
549253|NCT00852124|B2|Baseline|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.
VSL#3 : VSL#3 2 times daily"
549254|NCT00852124|B1|Baseline|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria
VSL#3 or placebo : 1 packet 2 x daily of placebo"
549255|NCT00852124|P2|Participant Flow|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.
VSL#3 : VSL#3 2 times daily"
549256|NCT00852124|P1|Participant Flow|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria
VSL#3 or placebo : 1 packet 2 x daily of placebo"
549257|NCT00852124|O1|Outcome|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria
VSL#3 or placebo : 1 packet 2 x daily of placebo"
549258|NCT00852124|E2|Reported Event|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.
VSL#3 : VSL#3 2 times daily"
549259|NCT00852124|E1|Reported Event|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria
VSL#3 or placebo : 1 packet 2 x daily of placebo"
549260|NCT00852137|B3|Baseline|Total|Total of all reporting groups
549261|NCT00852137|B2|Baseline|Vehicle|Vehicle gel once daily for 2 consecutive days
549262|NCT00852137|B1|Baseline|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
549263|NCT00852137|P2|Participant Flow|Vehicle|Vehicle gel once daily for 2 consecutive days
549264|NCT00852137|P1|Participant Flow|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
549265|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
549266|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
549267|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
549268|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
549269|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
549270|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
549271|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
549272|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
549273|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
549274|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
549275|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
549276|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
549277|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
549278|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
549279|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
549280|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
549281|NCT00852137|E2|Reported Event|Vehicle|Vehicle gel once daily for 2 consecutive days
549282|NCT00852137|E1|Reported Event|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
549283|NCT00853333|B4|Baseline|Total|Total of all reporting groups
549284|NCT00853333|B3|Baseline|Propofol|
549285|NCT00853333|B2|Baseline|Midazolam|
549286|NCT00853333|B1|Baseline|Dexmedetomidine|
549287|NCT00853333|P3|Participant Flow|Propofol|Sedation Arm 3, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
549288|NCT00853333|P2|Participant Flow|Midazolam|Sedation Arm 2, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
549289|NCT00853333|P1|Participant Flow|Dexmedetomidine|Sedation Arm 1, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
549290|NCT00853333|O3|Outcome|Propofol|
549291|NCT00853333|O2|Outcome|Midazolam|
549292|NCT00853333|O1|Outcome|Dexmedetomidine|
549293|NCT00853333|E3|Reported Event|Propofol|
549294|NCT00853333|E2|Reported Event|Midazolam|
549295|NCT00853333|E1|Reported Event|Dexmedetomidine|
549296|NCT00853385|B6|Baseline|Total|Total of all reporting groups
549297|NCT00853385|B5|Baseline|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549298|NCT00853385|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549299|NCT00853385|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549300|NCT00853385|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549301|NCT00853385|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549302|NCT00853385|P5|Participant Flow|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549321|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549563|NCT00853658|B1|Baseline|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
549303|NCT00853385|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549304|NCT00853385|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549305|NCT00853385|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549306|NCT00853385|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549307|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549308|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549309|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549310|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549311|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549312|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549313|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549314|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549315|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549316|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549317|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549318|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549319|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549320|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549322|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549323|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549324|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549325|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549326|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549327|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549328|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549329|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549330|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549331|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549332|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549333|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549334|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549335|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549336|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549337|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549338|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549339|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549508|NCT00853385|E10|Reported Event|CP-690,550 10 mg (Post Month 6)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
549509|NCT00853385|E9|Reported Event|CP-690,550 5 mg (Post Month 6)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
550319|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
549340|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549341|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549342|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549343|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549344|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549345|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549346|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549347|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549348|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549349|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549350|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549351|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549352|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549353|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549354|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549355|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549356|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549357|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549510|NCT00853385|E8|Reported Event|Adalimumab (Month 3 to 6)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
549564|NCT00853658|P3|Participant Flow|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
549565|NCT00853658|P2|Participant Flow|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
557836|NCT00875420|E5|Reported Event|Placebo|Oral once a day for 28 days
549358|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549359|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549360|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549361|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549362|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549363|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549364|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549365|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549366|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549367|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549368|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549369|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549370|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549371|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549372|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549373|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549374|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549375|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549554|NCT00853606|B1|Baseline|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
549566|NCT00853658|P1|Participant Flow|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
549376|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549377|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549378|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549379|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549380|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549381|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549382|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549383|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549384|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549385|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549386|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549387|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549388|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549389|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549390|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549391|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549392|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549393|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549555|NCT00853606|P1|Participant Flow|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
549567|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
549568|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
549394|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549395|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549396|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549397|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549398|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549399|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549400|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549401|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549402|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549403|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549404|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549405|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549406|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549407|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549408|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549409|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549410|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549411|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549556|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
549569|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
560072|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
549412|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549413|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549414|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549415|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549416|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549417|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549418|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549419|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549420|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549421|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549422|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549423|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549424|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549425|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549426|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549427|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549428|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549429|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549557|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
549570|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
549571|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
549430|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549431|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549432|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549433|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549434|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549435|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549436|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549437|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549438|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549439|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549440|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549441|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549442|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549443|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549444|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549445|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549446|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549447|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549448|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549449|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549450|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549451|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549452|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549453|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549454|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549455|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549456|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549457|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549458|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549459|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549460|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549461|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549462|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549463|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549464|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549465|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549466|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549467|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549468|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549558|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
549572|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
560073|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
549469|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549470|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549471|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549472|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549473|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549474|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549475|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549476|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549477|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549478|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549479|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549480|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549481|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549482|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549483|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549484|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549485|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549486|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549559|NCT00853606|E1|Reported Event|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
549560|NCT00853658|B4|Baseline|Total|Total of all reporting groups
549561|NCT00853658|B3|Baseline|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
549487|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549488|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549489|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549490|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549491|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549492|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549493|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549494|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549495|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549496|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549497|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549498|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549499|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549500|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549501|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549502|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549503|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
549504|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549505|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549506|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549507|NCT00853385|E11|Reported Event|Adalimumab (Post Month 6)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
549511|NCT00853385|E7|Reported Event|Placebo (Month 3 to 6)|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549512|NCT00853385|E6|Reported Event|CP-690,550 10 mg (Month 3 to 6)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
549513|NCT00853385|E5|Reported Event|CP-690,550 5 mg (Month 3 to 6)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
549514|NCT00853385|E4|Reported Event|Adalimumab (Up To Month 3)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 3.
549515|NCT00853385|E3|Reported Event|Placebo (Up To Month 3)|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
549516|NCT00853385|E2|Reported Event|CP-690,550 10 mg (Up To Month 3)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
549517|NCT00853385|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
549518|NCT00853567|B4|Baseline|Total|Total of all reporting groups
549519|NCT00853567|B3|Baseline|Placebo|Placebo treatment
549520|NCT00853567|B2|Baseline|50 mg Proellex|Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
549521|NCT00853567|B1|Baseline|25 g Proellex|Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
549522|NCT00853567|P1|Participant Flow|All Arms|Proellex: 25 mg or 50 mg or placebo oral daily dose
549523|NCT00853567|O3|Outcome|Placebo|"Placebo treatment
placebo: Placebo"
549524|NCT00853567|O2|Outcome|50 mg Proellex|"50 mg oral daily dose of Proellex
Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
549525|NCT00853567|O1|Outcome|25 g Proellex|"25 mg oral daily dose of Proellex
Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
549526|NCT00853567|E3|Reported Event|Placebo|"Placebo treatment
placebo: Placebo"
549527|NCT00853567|E2|Reported Event|50 mg Proellex|"50 mg oral daily dose of Proellex
Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
549528|NCT00853567|E1|Reported Event|25 g Proellex|"25 mg oral daily dose of Proellex
Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
549529|NCT00853593|B1|Baseline|Model 4396 LV Lead|Subjects underwent Model 4396 left ventricular lead implant attempt
549530|NCT00853593|P1|Participant Flow|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
549531|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration R-wave amplitude at 6 month.
549532|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration pacing impedance at 6 month.
549533|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration threshold captured at 0.5ms at 6 month.
549534|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode R-wave amplitude at implant.
549535|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode pacing impedance at 6 month.
549536|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode threshold captured at 0.5 ms at 6 month.
549537|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode R-wave amplitude at 6 month.
549538|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode pacing impedance at 6 month.
549539|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode threshold captured at 0.5ms at 6 month.
549540|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead and completed 1 month visit.
549541|NCT00853593|O1|Outcome|Model 4396 LV Lead|Model 4396 lead implant attempts.
549542|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
549543|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
549544|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
549545|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
549546|NCT00853593|O1|Outcome|Any Medtronic LV Lead (Attain Family Lead)|Subjects who underwent an implant attempt.
549547|NCT00853593|O1|Outcome|Any Transvenous LV Lead|Subjects who underwent an implant attempt.
549548|NCT00853593|O1|Outcome|Any Transvenous LV Lead|Subjects who underwent an implant attempt with successful CS cannulation.
549549|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
549550|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode threshold captured at 0.5ms at 3-month.
549551|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode capture at 0.5ms at 1-month.
549552|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects who underwent a Model 4396 left ventricular lead implant attempt
549553|NCT00853593|E1|Reported Event|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
549562|NCT00853658|B2|Baseline|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
549574|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
549575|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
549576|NCT00853658|E3|Reported Event|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
549577|NCT00853658|E2|Reported Event|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
549578|NCT00853658|E1|Reported Event|Combination of Aliskiren and Enalapril|Aliskiren/Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg
549579|NCT00853723|B4|Baseline|Total|Total of all reporting groups
549580|NCT00853723|B3|Baseline|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
549581|NCT00853723|B2|Baseline|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
549582|NCT00853723|B1|Baseline|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
549583|NCT00853723|P3|Participant Flow|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
549584|NCT00853723|P2|Participant Flow|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
549585|NCT00853723|P1|Participant Flow|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
549586|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
549587|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
549588|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
549589|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
549590|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
549591|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
549592|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
549593|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
549594|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
549595|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
549596|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
549597|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
549598|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
549599|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
549600|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
549601|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
549602|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
549603|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
549604|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
549605|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
549606|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
549607|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
549608|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
549609|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
549610|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
549772|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
549611|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
549612|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
549613|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
549614|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
549615|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
549616|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
549617|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
549618|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
549619|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
549620|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
549621|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
549622|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
549623|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
549624|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
549625|NCT00853723|E3|Reported Event|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
549626|NCT00853723|E2|Reported Event|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
549627|NCT00853723|E1|Reported Event|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
549628|NCT00853749|B3|Baseline|Total|Total of all reporting groups
549629|NCT00853749|B2|Baseline|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
549630|NCT00853749|B1|Baseline|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
549631|NCT00853749|P2|Participant Flow|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
549632|NCT00853749|P1|Participant Flow|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
549633|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
549634|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
549635|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
549636|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
549637|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
549638|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
549773|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
549639|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
549640|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
549641|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
549642|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
549643|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
549644|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
549645|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
549646|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
549647|NCT00853749|E2|Reported Event|PCV/PCV/13vPnC|"For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Local Reactions N=30; systematic (solicited) Systemic Events N=5."
549648|NCT00853749|E1|Reported Event|PCV/23vPS/13vPnC|"For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=8; systematic (solicited) Local Reactions N=44; systematic (solicited) Systemic Events N=9."
549649|NCT00853762|B5|Baseline|Total|Total of all reporting groups
549650|NCT00853762|B4|Baseline|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549651|NCT00853762|B3|Baseline|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549652|NCT00853762|B2|Baseline|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549653|NCT00853762|B1|Baseline|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549654|NCT00853762|P4|Participant Flow|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549655|NCT00853762|P3|Participant Flow|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549656|NCT00853762|P2|Participant Flow|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549657|NCT00853762|P1|Participant Flow|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 milligram (mg) subcutaneously (SC) as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549658|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549659|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549660|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549661|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549662|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549663|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549664|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549665|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549666|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549667|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549668|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549669|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549670|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549671|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549672|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549673|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549674|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549675|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549676|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549677|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549678|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549679|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549680|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
550320|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
549681|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549682|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549683|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549684|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549685|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549686|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549687|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549688|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549689|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549690|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549691|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549692|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549693|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549694|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549695|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549696|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549697|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549698|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549699|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549700|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549701|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
550321|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
549702|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549703|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549704|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549705|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549706|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549707|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549708|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549709|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549710|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549711|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549712|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549713|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549714|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549715|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549716|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549717|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549718|NCT00853762|E4|Reported Event|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC as loading dose twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549719|NCT00853762|E3|Reported Event|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549720|NCT00853762|E2|Reported Event|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549721|NCT00853762|E1|Reported Event|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
549722|NCT00853827|B3|Baseline|Total|Total of all reporting groups
549742|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
549723|NCT00853827|B2|Baseline|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
549724|NCT00853827|B1|Baseline|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
549725|NCT00853827|P2|Participant Flow|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
549726|NCT00853827|P1|Participant Flow|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
549727|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
549728|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
549729|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
549730|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
549731|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
549732|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
549733|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
549734|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
549735|NCT00853827|E2|Reported Event|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
549736|NCT00853827|E1|Reported Event|Aliskiren 300 mg|Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
549737|NCT00853840|B1|Baseline|All Subjects|In this 2-way crossover study, in Period 1, all 18 subjects were randomized to receive a single dose of either vardenafil 20 mg (Treatment A) or placebo (Treatment B), subsequent to treatment with 3 to 4 days of maraviroc 300 mg BID. All subjects were then crossed over to receive the second treatment in Period 2.
549738|NCT00853840|P2|Participant Flow|Non-matching Placebo + Maraviroc|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
549739|NCT00853840|P1|Participant Flow|Vardenafil + Maraviroc|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
549740|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
549741|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
550322|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
549743|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
549744|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
549745|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
549746|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
549747|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
549748|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
549749|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
549750|NCT00853840|E3|Reported Event|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
549751|NCT00853840|E2|Reported Event|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was to be taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
549752|NCT00853840|E1|Reported Event|Maraviroc Run-In|All subjects received 3 to 4 days of maraviroc 300 mg twice daily (BID) before receiving single oral doses of either vardenafil 20 mg (Treatment A) or placebo (Treatment B).
549753|NCT00853905|B3|Baseline|Total|Total of all reporting groups
549754|NCT00853905|B2|Baseline|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.
balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
549755|NCT00853905|B1|Baseline|Treatment 1(Triesence)|"0.2cc Triesence
Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
549756|NCT00853905|P2|Participant Flow|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.
balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
549757|NCT00853905|P1|Participant Flow|Treatment 1(Triesence)|"0.2cc Triesence
Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
549758|NCT00853905|O2|Outcome|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.
balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
549759|NCT00853905|O1|Outcome|Treatment 1(Triesence)|"0.2cc Triesence
Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
549760|NCT00853905|E2|Reported Event|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.
balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
549761|NCT00853905|E1|Reported Event|Treatment 1(Triesence)|"0.2cc Triesence
Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
549762|NCT00853957|B3|Baseline|Total|Total of all reporting groups
549763|NCT00853957|B2|Baseline|Amlodipine|Amlodipine 5mg titrated to 10 mg
549764|NCT00853957|B1|Baseline|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
549765|NCT00853957|P2|Participant Flow|Amlodipine|Amlodipine 5mg titrated to 10 mg
549766|NCT00853957|P1|Participant Flow|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
549767|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
549768|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
549769|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
549770|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
549771|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
560074|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
549774|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
549775|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
549776|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
549777|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
549778|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
549779|NCT00853957|E2|Reported Event|Amlodipine|Amlodipine 5mg titrated to 10 mg
549780|NCT00853957|E1|Reported Event|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
549781|NCT00853970|B3|Baseline|Total|Total of all reporting groups
549782|NCT00853970|B2|Baseline|Placebo|one drop daily in study eye for 2 weeks
549783|NCT00853970|B1|Baseline|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
549784|NCT00853970|P2|Participant Flow|Placebo|dosed 1 drop daily into the study eye for 2 weeks
549785|NCT00853970|P1|Participant Flow|Bromfenac Ophthalmic Solution 0.09%|dosed 1 drop daily into the study eye for 2 weeks
549786|NCT00853970|O2|Outcome|Placebo|one drop daily in study eye for 2 weeks
549787|NCT00853970|O1|Outcome|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
549788|NCT00853970|O2|Outcome|Placebo|one drop daily in study eye for 2 weeks
549789|NCT00853970|O1|Outcome|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
549790|NCT00853970|E2|Reported Event|Placebo|one drop daily in study eye for 2 weeks
549791|NCT00853970|E1|Reported Event|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
549792|NCT00853996|B1|Baseline|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally"
549793|NCT00853996|P1|Participant Flow|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally"
549794|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally"
549795|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally"
549796|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally"
549797|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally"
549798|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally"
549799|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally"
549800|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally"
549801|NCT00853996|E1|Reported Event|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally"
549802|NCT00854087|B3|Baseline|Total|Total of all reporting groups
549803|NCT00854087|B2|Baseline|Placebo|"Pill without Fuzheng Huayu (sugar pill)
Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
549804|NCT00854087|B1|Baseline|Fuzheng Huayu|"Pill with Fuzheng Huayu
Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
549805|NCT00854087|P2|Participant Flow|Placebo|"Pill without Fuzheng Huayu (sugar pill)
Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
549806|NCT00854087|P1|Participant Flow|Fuzheng Huayu|"Pill with Fuzheng Huayu
Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
549807|NCT00854087|O2|Outcome|Placebo|"Pill without Fuzheng Huayu (sugar pill)
Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
549808|NCT00854087|O1|Outcome|Fuzheng Huayu|"Pill with Fuzheng Huayu
Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
549809|NCT00854087|E2|Reported Event|Placebo|"Pill without Fuzheng Huayu (sugar pill)
Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
549810|NCT00854087|E1|Reported Event|Fuzheng Huayu|"Pill with Fuzheng Huayu
Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
549811|NCT00854113|B12|Baseline|Total|Total of all reporting groups
549812|NCT00854113|B11|Baseline|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
549813|NCT00854113|B10|Baseline|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
549814|NCT00854113|B9|Baseline|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
549815|NCT00854113|B8|Baseline|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
549816|NCT00854113|B7|Baseline|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
549817|NCT00854113|B6|Baseline|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
549818|NCT00854113|B5|Baseline|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
549819|NCT00854113|B4|Baseline|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
549820|NCT00854113|B3|Baseline|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
549821|NCT00854113|B2|Baseline|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
560075|NCT00882687|O4|Outcome|Placebo|
549822|NCT00854113|B1|Baseline|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
549823|NCT00854113|P11|Participant Flow|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
549824|NCT00854113|P10|Participant Flow|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
549825|NCT00854113|P9|Participant Flow|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
549826|NCT00854113|P8|Participant Flow|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
549827|NCT00854113|P7|Participant Flow|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
549828|NCT00854113|P6|Participant Flow|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
549829|NCT00854113|P5|Participant Flow|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
549830|NCT00854113|P4|Participant Flow|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
549831|NCT00854113|P3|Participant Flow|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
549832|NCT00854113|P2|Participant Flow|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
549833|NCT00854113|P1|Participant Flow|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
549834|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
549835|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
549836|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
549837|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
549838|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
549839|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
549840|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
549841|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
549842|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
549843|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
549844|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
549845|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
549846|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
549847|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
549848|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
549849|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
549850|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
549851|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
549852|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
549853|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
549854|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
549855|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
549856|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
549857|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
549858|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
549859|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
549860|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
549861|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
549862|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
549863|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
549864|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
549865|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
549866|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
549867|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
549868|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
549869|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
549870|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
549871|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
549872|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
549873|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
549874|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
549875|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
549876|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
549877|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
549878|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
549879|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
549880|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
549881|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
549882|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
549883|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
549884|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
549885|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
549886|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
549887|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
549888|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
549889|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
549890|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
549891|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
549892|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
549893|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
549894|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
549895|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
549896|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
549897|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
549898|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
549899|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
549900|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
549901|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
549902|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
549903|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
549904|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
549905|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
549906|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
549907|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
549908|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
549909|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
549910|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
549911|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
549912|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
549913|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
549914|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
549915|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
549916|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
549917|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
549918|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
549919|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
549920|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
549921|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
549922|NCT00854113|E11|Reported Event|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
549923|NCT00854113|E10|Reported Event|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
550323|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
549924|NCT00854113|E9|Reported Event|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
549925|NCT00854113|E8|Reported Event|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
549926|NCT00854113|E7|Reported Event|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
549927|NCT00854113|E6|Reported Event|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
549928|NCT00854113|E5|Reported Event|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
549929|NCT00854113|E4|Reported Event|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
549930|NCT00854113|E3|Reported Event|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
549931|NCT00854113|E2|Reported Event|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
549932|NCT00854113|E1|Reported Event|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
549933|NCT00854308|B3|Baseline|Total|Total of all reporting groups
549934|NCT00854308|B2|Baseline|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
549935|NCT00854308|B1|Baseline|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
549936|NCT00854308|P2|Participant Flow|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
549937|NCT00854308|P1|Participant Flow|MetMAb + Erlotinib|MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
549938|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
549939|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
549940|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
549941|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
549942|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
549943|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
549944|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
549945|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
549946|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
549947|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
549948|NCT00854308|E2|Reported Event|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
549949|NCT00854308|E1|Reported Event|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
549950|NCT00854360|B5|Baseline|Total|Total of all reporting groups
549951|NCT00854360|B4|Baseline|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
549952|NCT00854360|B3|Baseline|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
549953|NCT00854360|B2|Baseline|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
549954|NCT00854360|B1|Baseline|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
549955|NCT00854360|P4|Participant Flow|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
549956|NCT00854360|P3|Participant Flow|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
549957|NCT00854360|P2|Participant Flow|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
549958|NCT00854360|P1|Participant Flow|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) and two actuations of placebo HFA once daily.
549959|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
549960|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
549961|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
549962|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
550324|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
549963|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
549964|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
549965|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
549966|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
549967|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
549968|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
549969|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
549970|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
549971|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
549972|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
549973|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
549974|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
549975|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
549976|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
549977|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
549978|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
549979|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
549980|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
549981|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
549982|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
549983|NCT00854360|E4|Reported Event|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
549984|NCT00854360|E3|Reported Event|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
549985|NCT00854360|E2|Reported Event|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
549986|NCT00854360|E1|Reported Event|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
549987|NCT00854373|B3|Baseline|Total|Total of all reporting groups
549988|NCT00854373|B2|Baseline|Placebo|"Saline
Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
549989|NCT00854373|B1|Baseline|Bravelle|"Bravelle
Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
549990|NCT00854373|P2|Participant Flow|Placebo|"Saline
Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
549991|NCT00854373|P1|Participant Flow|Bravelle|"Bravelle
Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
549992|NCT00854373|O2|Outcome|Placebo|"Saline
Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
549993|NCT00854373|O1|Outcome|Bravelle|"Bravelle
Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
549994|NCT00854373|O2|Outcome|Placebo|"Saline
Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
549995|NCT00854373|O1|Outcome|Bravelle|"Bravelle
Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
549996|NCT00854373|O2|Outcome|Placebo|"Saline
Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
549997|NCT00854373|O1|Outcome|Bravelle|"Bravelle
Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
549998|NCT00854373|E2|Reported Event|Placebo|"Saline
Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
549999|NCT00854373|E1|Reported Event|Bravelle|"Bravelle
Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
550048|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
550000|NCT00854581|B1|Baseline|Induction + Maintenance Therapy|All patients are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR)
550001|NCT00854581|P1|Participant Flow|Induction + Maintenance Therapy|All patients are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR)
550002|NCT00854581|O1|Outcome|Induction + Maintenance Therapy|All patients are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR)
550003|NCT00854581|E2|Reported Event|Maintenance Therapy|"Zidovudine + Interferon alfa-2b + PEG Interferon alfa-2b
PEG-interferon alfa-2b: PEG-IFN-alfa2b 1.5 ug/kg SQ weekly.
Interferon alfa-2b: Days 3 - 14: Interferon Alpha-2b 5 10 million units IV twice daily.
Valproic Acid: Patients will be started on one capsule (250 mg) with water twice daily.
Zidovudine: Days 1-2: (0-48 hours) Zidovudine (AZT) 1.5 grams intravenously (IV) twice daily. Days 3-14: Zidovudine (AZT) 1.5 grams IV twice daily and Interferon Alpha-2b 5 10 million units IV twice daily. Subsequent doses dependent on patient response.
Molecular Evaluation/Analysis of Malignant Clones of ATLL: Blood Sample - Baseline/Pre-Treatment, months 3 and 6, End of Month 12, Disease Progession"
550004|NCT00854581|E1|Reported Event|Induction Therapy|"Zidovudine + Interferon alfa-2b
Interferon alfa-2b: Days 3 - 14: Interferon Alpha-2b 5 10 million units IV twice daily.
Zidovudine: Days 1-2: (0-48 hours) Zidovudine (AZT) 1.5 grams intravenously (IV) twice daily. Days 3-14: Zidovudine (AZT) 1.5 grams IV twice daily and Interferon Alpha-2b 5 10 million units IV twice daily. Subsequent doses dependent on patient response.
NF-kB Inhibition: Blood Sample - Baseline/Pre-Treatment, Induction,"
550005|NCT00854594|B3|Baseline|Total|Total of all reporting groups
550006|NCT00854594|B2|Baseline|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.
Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
550007|NCT00854594|B1|Baseline|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
550008|NCT00854594|P2|Participant Flow|ReSPECT Intervention|"Providers within sites randomized to the intervention arm will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.
Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention Community-Based Outpatient Clinics (CBOCs) by modeling interprofessional team practices during SMAs for diabetes mellitus (DM) patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
550009|NCT00854594|P1|Participant Flow|Control|Providers within sites randomized to the control arm will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
550010|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.
Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
550011|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
550012|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.
Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
550013|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
550014|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.
Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
550015|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
550016|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.
Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
550017|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
550018|NCT00854594|E2|Reported Event|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.
Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
550019|NCT00854594|E1|Reported Event|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
550020|NCT00854607|B1|Baseline|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
550021|NCT00854607|P1|Participant Flow|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven Invasive Aspergillosis (IA) infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
550022|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
550023|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
550024|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
550025|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
550026|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
550027|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
550028|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
550029|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
550030|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
550031|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
550032|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
550033|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
550034|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
550035|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
550036|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
550037|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
550038|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
550039|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
550040|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
550041|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
550042|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
550043|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
550044|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
550045|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
550046|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
550047|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
550049|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
550050|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 6.
550051|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
550052|NCT00854607|E1|Reported Event|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, and were started on standard of care antifungal therapy.
550053|NCT00854620|B1|Baseline|Sorafenib|"Cycle 1: 400 mg BID sorafenib
Cycle 2: 600 mg BID sorafenib
Cycle 3+: 800 mg BID sorafenib
Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
550054|NCT00854620|P1|Participant Flow|Sorafenib|"Cycle 1: 400 mg BID sorafenib
Cycle 2: 600 mg BID sorafenib
Cycle 3+: 800 mg BID sorafenib
Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
550055|NCT00854620|O1|Outcome|Sorafenib|"Cycle 1: 400 mg BID sorafenib
Cycle 2: 600 mg BID sorafenib
Cycle 3+: 800 mg BID sorafenib
Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
550056|NCT00854620|E1|Reported Event|Sorafenib|"Cycle 1: 400 mg BID sorafenib
Cycle 2: 600 mg BID sorafenib
Cycle 3+: 800 mg BID sorafenib
Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
550057|NCT00854724|B3|Baseline|Total|Total of all reporting groups
550058|NCT00854724|B2|Baseline|Puerarin, Then Placebo|
550059|NCT00854724|B1|Baseline|Placebo, Then Puerarin|
550060|NCT00854724|P2|Participant Flow|Puerarin, Then Placebo|
550061|NCT00854724|P1|Participant Flow|Placebo, Then Puerarin|
550062|NCT00854724|O2|Outcome|Puerarin, Then Placebo|
550063|NCT00854724|O1|Outcome|Placebo, Then Puerarin|
550064|NCT00854724|E2|Reported Event|Puerarin, Then Placebo|
550065|NCT00854724|E1|Reported Event|Placebo, Then Puerarin|
550066|NCT00854906|B1|Baseline|All Study Participants|These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). All study participants participated in both the KTBUT Study Arm and the FTBUT Study Arm.
550067|NCT00854906|P1|Participant Flow|All Study Participants|These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). Both KTBUT and FTBUT were measured in all study participants.
550068|NCT00854906|O1|Outcome|All Study Participants|
550069|NCT00854906|O2|Outcome|FTBUT|
550070|NCT00854906|O1|Outcome|KTBUT|
550071|NCT00854906|E2|Reported Event|FTBUT|
550072|NCT00854906|E1|Reported Event|KTBUT|
550073|NCT00855062|B3|Baseline|Total|Total of all reporting groups
550074|NCT00855062|B2|Baseline|Placebo|Placebo minocycline capsules every 12 hours
550075|NCT00855062|B1|Baseline|Minocycline|Minocycline 100 mg orally every 12 hours
550076|NCT00855062|P2|Participant Flow|Placebo|Placebo minocycline capsules every 12 hours
550077|NCT00855062|P1|Participant Flow|Minocycline|Minocycline 100 mg orally every 12 hours
550078|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
550079|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
550080|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
550081|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
550082|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
550083|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
550084|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
550085|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
550086|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
550087|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
550088|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
550089|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
550090|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
550091|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
550092|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
550093|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
550094|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
550095|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
550096|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
550097|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
550098|NCT00855062|E2|Reported Event|Placebo|Placebo minocycline capsules every 12 hours
550099|NCT00855062|E1|Reported Event|Minocycline|Minocycline 100 mg orally every 12 hours
550100|NCT00855166|B3|Baseline|Total|Total of all reporting groups
550101|NCT00855166|B2|Baseline|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
550102|NCT00855166|B1|Baseline|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
550103|NCT00855166|P2|Participant Flow|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
550104|NCT00855166|P1|Participant Flow|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
550105|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
550106|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
550107|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
550108|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
550109|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
550110|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
550111|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
550112|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
550113|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
550114|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
550115|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
550116|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
550117|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
550118|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
550119|NCT00855166|E2|Reported Event|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
550120|NCT00855166|E1|Reported Event|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
550121|NCT00855218|B3|Baseline|Total|Total of all reporting groups
550122|NCT00855218|B2|Baseline|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550123|NCT00855218|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550124|NCT00855218|P2|Participant Flow|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550125|NCT00855218|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550126|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550127|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550128|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550129|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550130|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550131|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550155|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months
Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
550132|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550133|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550134|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550135|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550136|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550137|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550138|NCT00855218|E2|Reported Event|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo on cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550139|NCT00855218|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib on cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
550140|NCT00855309|B3|Baseline|Total|Total of all reporting groups
550141|NCT00855309|B2|Baseline|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
550142|NCT00855309|B1|Baseline|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
550143|NCT00855309|P2|Participant Flow|Low-dose IV Acyclovir|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
550144|NCT00855309|P1|Participant Flow|Weight-based IV Acyclovir|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
550145|NCT00855309|O2|Outcome|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
550146|NCT00855309|O1|Outcome|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
550147|NCT00855309|E2|Reported Event|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
550148|NCT00855309|E1|Reported Event|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
550149|NCT00855439|B3|Baseline|Total|Total of all reporting groups
550150|NCT00855439|B2|Baseline|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.
Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
550151|NCT00855439|B1|Baseline|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months
Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
550152|NCT00855439|P2|Participant Flow|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.
Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
550153|NCT00855439|P1|Participant Flow|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months
Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
550154|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.
Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
550219|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550156|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.
Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
550157|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months
Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
550158|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.
Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
550159|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months
Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
550160|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.
Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
550161|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months
Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
550162|NCT00855439|E2|Reported Event|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.
Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
550163|NCT00855439|E1|Reported Event|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months
Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
550164|NCT00855465|B3|Baseline|Total|Total of all reporting groups
550165|NCT00855465|B2|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550166|NCT00855465|B1|Baseline|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550167|NCT00855465|P2|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550168|NCT00855465|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550169|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550170|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550171|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550172|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550173|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550174|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550175|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550176|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550177|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550178|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550179|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550180|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550181|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550182|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550183|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550184|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550185|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550318|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550186|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550187|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550188|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550189|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550190|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550191|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550192|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550193|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550194|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550195|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550196|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550197|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550198|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550199|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550200|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550201|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550202|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550203|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550204|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550205|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550206|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550207|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550208|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550209|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550210|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550211|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550212|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550213|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550214|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550215|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550216|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550217|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550218|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550220|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550221|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550222|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550223|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550224|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550225|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550226|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550227|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550228|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550229|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550230|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550231|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550232|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550233|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550234|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550235|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550236|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550237|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550238|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550239|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550240|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550241|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550242|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550243|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550244|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550245|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550246|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550247|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550248|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550249|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550250|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550251|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550252|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550253|NCT00855465|E2|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
550254|NCT00855465|E1|Reported Event|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
550255|NCT00855582|B4|Baseline|Total|Total of all reporting groups
550256|NCT00855582|B3|Baseline|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550257|NCT00855582|B2|Baseline|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550258|NCT00855582|B1|Baseline|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550259|NCT00855582|P3|Participant Flow|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550260|NCT00855582|P2|Participant Flow|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550261|NCT00855582|P1|Participant Flow|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550262|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550263|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550264|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550265|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550266|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550267|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550268|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550269|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550270|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550271|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550272|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550273|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550274|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550275|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550276|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550277|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550278|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550279|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550280|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550281|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550282|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550283|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550284|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550285|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550286|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550287|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550288|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550289|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550290|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550291|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550292|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550293|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550294|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550295|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550296|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550297|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550298|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550299|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550300|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550301|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550302|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550303|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550304|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550305|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550306|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550307|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550308|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550309|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550310|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550311|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550312|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550313|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550314|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550315|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550316|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550317|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550325|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550326|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550327|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550328|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550329|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
550330|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550331|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
550332|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550333|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
550334|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550335|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
550336|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550337|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
550338|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550339|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
550340|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550341|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
550342|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550343|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
550344|NCT00855582|E3|Reported Event|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
550345|NCT00855582|E2|Reported Event|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
550346|NCT00855582|E1|Reported Event|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
550347|NCT00855595|B3|Baseline|Total|Total of all reporting groups
550348|NCT00855595|B2|Baseline|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550349|NCT00855595|B1|Baseline|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550350|NCT00855595|P2|Participant Flow|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550351|NCT00855595|P1|Participant Flow|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550352|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550353|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550354|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550355|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550356|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550357|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550358|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550359|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550360|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550361|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550362|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550363|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550364|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550365|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550366|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550367|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550368|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550369|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550370|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550371|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550372|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550373|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550374|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550375|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550376|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550377|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550378|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550379|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550380|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550381|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550382|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
550383|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
550384|NCT00855595|E2|Reported Event|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and systemic doxycycline 40 mg once daily for 12 weeks
550385|NCT00855595|E1|Reported Event|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and systemic doxycycline 40 mg once daily for 12 weeks
550386|NCT00855738|B1|Baseline|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550387|NCT00855738|P1|Participant Flow|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550388|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550389|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550390|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550391|NCT00855738|O1|Outcome|All Antiepileptic Drugs|
550392|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550393|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550394|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550395|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550396|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550397|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550398|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550399|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550400|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550401|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550402|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550403|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550404|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550442|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550405|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550406|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550407|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550408|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550409|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
550410|NCT00855738|E2|Reported Event|Pregabalin (Pregabalin Only)|
550411|NCT00855738|E1|Reported Event|All Antiepileptic Drugs (Including Pregabalin)|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin
550412|NCT00848926|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550413|NCT00848926|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
550414|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550415|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550416|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550417|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550418|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550419|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550420|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550421|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550422|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550423|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550424|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550425|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550426|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550427|NCT00848926|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
550428|NCT00848965|B1|Baseline|Placebo/FP 25, 50, 100, 200 µg|Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
550429|NCT00848965|P1|Participant Flow|Placebo/FP 25, 50, 100, 200 µg|Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
550430|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550431|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550432|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550433|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550434|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
550435|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550436|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550437|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550438|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550439|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
550440|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550441|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550443|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550444|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
550445|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550446|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550447|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550448|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550449|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
550450|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550451|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550452|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550453|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550454|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
550455|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550456|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550457|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550458|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550459|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
550460|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550461|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550462|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550463|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550464|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
550465|NCT00848965|E5|Reported Event|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550466|NCT00848965|E4|Reported Event|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550467|NCT00848965|E3|Reported Event|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550468|NCT00848965|E2|Reported Event|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
550469|NCT00848965|E1|Reported Event|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
550470|NCT00849017|B4|Baseline|Total|Total of all reporting groups
550471|NCT00849017|B3|Baseline|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550472|NCT00849017|B2|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550473|NCT00849017|B1|Baseline|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550474|NCT00849017|P3|Participant Flow|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550475|NCT00849017|P2|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550476|NCT00849017|P1|Participant Flow|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550477|NCT00849017|O2|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550478|NCT00849017|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550583|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550479|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550480|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550481|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550482|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550483|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550484|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550485|NCT00849017|O3|Outcome|Albiglutide 50 mg Weekly|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550486|NCT00849017|O2|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550487|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550488|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550489|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550490|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550491|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550492|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550493|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550494|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550495|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550496|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550497|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550498|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550499|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550500|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550501|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550502|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550503|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550504|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550505|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550506|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550507|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550508|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550509|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550510|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550511|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550512|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550513|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550514|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550515|NCT00849017|E3|Reported Event|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550516|NCT00849017|E2|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550517|NCT00849017|E1|Reported Event|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
550518|NCT00849056|B3|Baseline|Total|Total of all reporting groups
550519|NCT00849056|B2|Baseline|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550520|NCT00849056|B1|Baseline|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550521|NCT00849056|P2|Participant Flow|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550522|NCT00849056|P1|Participant Flow|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550523|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550524|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550525|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550584|NCT00849147|E1|Reported Event|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
560076|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
550526|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550527|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550528|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550529|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550530|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550531|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550532|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550533|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550534|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550535|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550536|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550537|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550538|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550539|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550540|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550587|NCT00849186|O1|Outcome|Sunitinib|"sunitinib malate: oral
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery"
550541|NCT00849056|E2|Reported Event|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550542|NCT00849056|E1|Reported Event|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
550543|NCT00849108|B4|Baseline|Total|Total of all reporting groups
550544|NCT00849108|B3|Baseline|Cohort 2: Efficacy Exercise Stress|"Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at exercise stress over a 1-day period.
For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose."
550545|NCT00849108|B2|Baseline|Cohort 2: Pharm Stress|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at pharmacologic stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose.
550546|NCT00849108|B1|Baseline|Cohort 1 Dose Ranging and Dose Interval|Patients received either 2 or 3 IV bolus injhections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period
550547|NCT00849108|P2|Participant Flow|Cohort 2 Preliminary Efficacy Pharmacologic Stress|Patients received 2 injections of BMS747158: 1 at rest and 1 at Pharmacologic stress, over a 1-day period.
550548|NCT00849108|P1|Participant Flow|Cohort 1 Dose Ranging and Dose Interval|Patients received 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 at pharmacologic/exercise stress, over a 1-day or 2-day period
550549|NCT00849108|O1|Outcome|Cohort 2: Efficacy/Safety|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose. For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose.
550550|NCT00849108|O1|Outcome|Cohort 1 Dose Ranging and Dose Interval|Subjects received 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 at pharmacologic/exercise stress, over a 1-day or 2-day period
550551|NCT00849108|O1|Outcome|Cohort 2 Efficacy/Safety|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose. For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose.
550552|NCT00849108|O1|Outcome|Cohort 1: Dose Acquistion Time Product|Subjects received either 2 or 3 IV bolus injhections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period
550553|NCT00849108|E2|Reported Event|Cohort 2: Efficacy in Pharm Stress|"Patients receive 2 IV injections of BMS747158:at rest and stress
For the Pharmacologic (Adenosine) Stress:
Doses range at rest between 2.9 and 3.4 mCi.
Dose range at stress between 5.8 and 8.2 mCi (factor of 2.0 to 2.4 greater than the rest dose).
For the Exercise Stress:
Doses at rest were to range between 1.7 and 2.0 mCi.
Doses under stress were to be a factor of 3.0 to 3.6 greater than the rest dose, resulting in a range between 5.1 and 7.2 mCi."
550554|NCT00849108|E1|Reported Event|Cohort 1: Dose Range and Dose Interval|"Patients to receive either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during pharmacological or exercise stress, over a 1-day or 2-day period.
BMS747158: dosages at rest and at stress were not to exceed a total of 14 mCi.
Cohort 1: Patients received either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period."
550555|NCT00849121|B3|Baseline|Total|Total of all reporting groups
550556|NCT00849121|B2|Baseline|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
550557|NCT00849121|B1|Baseline|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
550558|NCT00849121|P2|Participant Flow|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
550559|NCT00849121|P1|Participant Flow|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally (i.d.) biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally every 3 months until radiographic disease progression"
550585|NCT00849186|B1|Baseline|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery"
550586|NCT00849186|P1|Participant Flow|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery"
560077|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
550560|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
550561|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
550562|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
550563|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
550564|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
550565|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
550566|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
550567|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
550568|NCT00849121|E2|Reported Event|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
550569|NCT00849121|E1|Reported Event|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.
pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
550570|NCT00849147|B1|Baseline|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550571|NCT00849147|P1|Participant Flow|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550572|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550573|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550574|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550575|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550576|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550577|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550578|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550579|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550580|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550581|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550582|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
550588|NCT00849186|O1|Outcome|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery"
550589|NCT00849186|O1|Outcome|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery"
550590|NCT00849186|E1|Reported Event|Sunitinib|"sunitinib malate: oral
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery"
550591|NCT00849212|B1|Baseline|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
550592|NCT00849212|P1|Participant Flow|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
550593|NCT00849212|O1|Outcome|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
550594|NCT00849212|O1|Outcome|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
550595|NCT00849212|E1|Reported Event|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
550596|NCT00849290|B1|Baseline|APC8015F|
550597|NCT00849290|P1|Participant Flow|APC8015F|APC8015F (cryopreserved autologous PBMCs, including APCs, that have been thawed and then activated in vitro with a recombinant fusion protein). Each dose contains a minimum of 3 X 10^6 CD54+ cells administered intravenously; treatment is 3 doses approximately 2 weeks apart.
550598|NCT00849290|O1|Outcome|APC8015F|
550599|NCT00849290|E1|Reported Event|APC8015F|
550600|NCT00849381|B1|Baseline|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
550601|NCT00849381|P1|Participant Flow|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
550602|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
550603|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
550604|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
550605|NCT00849381|E1|Reported Event|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
550606|NCT00855816|B3|Baseline|Total|Total of all reporting groups
550607|NCT00855816|B2|Baseline|Treatment as Usual|No intervention: Treatment as usual
550608|NCT00855816|B1|Baseline|Breathing Training|relaxation training
550609|NCT00855816|P2|Participant Flow|Treatment as Usual|No intervention - treatment as usual
550610|NCT00855816|P1|Participant Flow|Breathing Training|relaxation training
550611|NCT00855816|O2|Outcome|Treatment as Usual|No intervention: treatment as usual
550612|NCT00855816|O1|Outcome|Breathing Training|relaxation training
550613|NCT00855816|E2|Reported Event|Treatment as Usual|No intervention: Treatment as usual
550614|NCT00855816|E1|Reported Event|Breathing Training|relaxation training
550615|NCT00855842|B1|Baseline|Osmotic Dilator|osmotic dilator
550616|NCT00855842|P1|Participant Flow|Osmotic Dilator|osmotic dilator
550617|NCT00855842|O1|Outcome|Osmotic Dilator|osmotic dilator
550618|NCT00855842|E1|Reported Event|Osmotic Dilator|osmotic dilator
550619|NCT00855868|B3|Baseline|Total|Total of all reporting groups
550620|NCT00855868|B2|Baseline|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
550621|NCT00855868|B1|Baseline|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
550622|NCT00855868|P2|Participant Flow|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
550623|NCT00855868|P1|Participant Flow|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
550624|NCT00855868|O2|Outcome|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
550625|NCT00855868|O1|Outcome|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
550626|NCT00855868|E2|Reported Event|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
550627|NCT00855868|E1|Reported Event|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
550628|NCT00855894|B1|Baseline|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
550629|NCT00855894|P1|Participant Flow|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
550630|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
550631|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
550632|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
550633|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
550634|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
550635|NCT00855894|E1|Reported Event|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
550636|NCT00855920|B4|Baseline|Total|Total of all reporting groups
550637|NCT00855920|B3|Baseline|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
550638|NCT00855920|B2|Baseline|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550639|NCT00855920|B1|Baseline|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550640|NCT00855920|P3|Participant Flow|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
550641|NCT00855920|P2|Participant Flow|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550642|NCT00855920|P1|Participant Flow|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550643|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
550644|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550645|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550646|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
550647|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550648|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550649|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
550650|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550651|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550652|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
550653|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550654|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
550655|NCT00855920|E3|Reported Event|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
550656|NCT00855920|E2|Reported Event|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in arm (Placebo [for Rilonacept] and Indomethacin).
550657|NCT00855920|E1|Reported Event|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in this arm.
550658|NCT00855933|B3|Baseline|Total|Total of all reporting groups
550659|NCT00855933|B2|Baseline|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
550660|NCT00855933|B1|Baseline|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
550661|NCT00855933|P2|Participant Flow|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
550662|NCT00855933|P1|Participant Flow|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
550663|NCT00855933|O2|Outcome|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
550664|NCT00855933|O1|Outcome|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
550665|NCT00855933|E2|Reported Event|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
550666|NCT00855933|E1|Reported Event|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
550667|NCT00855959|B1|Baseline|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550668|NCT00855959|P1|Participant Flow|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550669|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550670|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550671|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550672|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550673|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550674|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550675|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550676|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550677|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550704|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
550747|NCT00856245|O1|Outcome|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
550678|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550679|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550680|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550681|NCT00855959|E1|Reported Event|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
550682|NCT00856024|B1|Baseline|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550683|NCT00856024|P1|Participant Flow|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550684|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550685|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550686|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550687|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550688|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550689|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550690|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550691|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550692|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550693|NCT00856024|E1|Reported Event|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
550694|NCT00856050|B1|Baseline|Letrozole|letrozole 2.5mg by mouth per day
550695|NCT00856050|P1|Participant Flow|Letrozole|Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
550696|NCT00856050|O1|Outcome|Letrozole|letrozole 2.5mg by mouth per day
550697|NCT00856050|E1|Reported Event|Letrozole|Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
550698|NCT00856193|B1|Baseline|All Randomized Patients|NVA237 50 μg capsules for inhalation once daily with Concept 1 device. Matching placebo 50 µg capsules for inhalation once daily with Concept 1 device.
550699|NCT00856193|P2|Participant Flow|Placebo Then NVA237 50μg|Placebo 50 µg capsules followed by NVA237 50 µg capsules for inhalation once daily with Concept 1 device.
550700|NCT00856193|P1|Participant Flow|NVA237 50μg Then Placebo|NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
550701|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
550702|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
550703|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
550705|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
550706|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
550707|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
550708|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
550709|NCT00856193|E2|Reported Event|NVA237 50 μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
550710|NCT00856193|E1|Reported Event|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
550711|NCT00856206|B3|Baseline|Total|Total of all reporting groups
550712|NCT00856206|B2|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
550713|NCT00856206|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
550714|NCT00856206|P2|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
550715|NCT00856206|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
550716|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
550717|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
550718|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
550719|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
550720|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
550721|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
550722|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
550723|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
550724|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
550725|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
550726|NCT00856206|E2|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
550727|NCT00856206|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
550728|NCT00856232|B4|Baseline|Total|Total of all reporting groups
550729|NCT00856232|B3|Baseline|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
550730|NCT00856232|B2|Baseline|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
550731|NCT00856232|B1|Baseline|Standard Therapy|Standard emergency department evaluation and treatment for headache
550732|NCT00856232|P3|Participant Flow|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
550733|NCT00856232|P2|Participant Flow|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
550734|NCT00856232|P1|Participant Flow|Standard Therapy|Standard emergency department evaluation and treatment for headache
550735|NCT00856232|O3|Outcome|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
550736|NCT00856232|O2|Outcome|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
550737|NCT00856232|O1|Outcome|Standard Therapy|Standard emergency department evaluation and treatment for headache
550738|NCT00856232|O3|Outcome|Oxygen at 15 L / Min|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
550739|NCT00856232|O2|Outcome|Medical Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
550740|NCT00856232|O1|Outcome|Standard Therapy|Standard emergency department evaluation and treatment for headache
550741|NCT00856232|E3|Reported Event|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
550742|NCT00856232|E2|Reported Event|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
550743|NCT00856232|E1|Reported Event|Standard Therapy|Standard emergency department evaluation and treatment for headache
550744|NCT00856245|B1|Baseline|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
550745|NCT00856245|P1|Participant Flow|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
550746|NCT00856245|O1|Outcome|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
550748|NCT00856245|E1|Reported Event|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
550749|NCT00856284|B4|Baseline|Total|Total of all reporting groups
550750|NCT00856284|B3|Baseline|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
550751|NCT00856284|B2|Baseline|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550752|NCT00856284|B1|Baseline|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550753|NCT00856284|P3|Participant Flow|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
550754|NCT00856284|P2|Participant Flow|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550755|NCT00856284|P1|Participant Flow|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550756|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
550757|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550758|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550759|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
550760|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550761|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550762|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
550763|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550764|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550765|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
550766|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550767|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550768|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
550769|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550770|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550771|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
550772|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550773|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550774|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
550941|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550775|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550776|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550777|NCT00856284|E3|Reported Event|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
550778|NCT00856284|E2|Reported Event|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550779|NCT00856284|E1|Reported Event|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
550780|NCT00856297|B6|Baseline|Total|Total of all reporting groups
550781|NCT00856297|B5|Baseline|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550782|NCT00856297|B4|Baseline|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.
550783|NCT00856297|B3|Baseline|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
550784|NCT00856297|B2|Baseline|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
550785|NCT00856297|B1|Baseline|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
550786|NCT00856297|P5|Participant Flow|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550787|NCT00856297|P4|Participant Flow|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550788|NCT00856297|P3|Participant Flow|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
550789|NCT00856297|P2|Participant Flow|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
550790|NCT00856297|P1|Participant Flow|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
550791|NCT00856297|O3|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
550792|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
550793|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
550794|NCT00856297|O4|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550795|NCT00856297|O3|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550796|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination..
550797|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
550798|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550799|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550800|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550801|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550802|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550803|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550804|NCT00856297|O2|Outcome|Licensed Comparator/MenACWY-CRM|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study, and one booster dose of MenACWY- CRM conjugate vaccine in the present study at 3 years after primary vaccination.
550805|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550806|NCT00856297|O1|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
550807|NCT00856297|O1|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
550808|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
550809|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
550810|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
550811|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
550812|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
550813|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
550814|NCT00856297|E5|Reported Event|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
550815|NCT00856297|E4|Reported Event|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.
550816|NCT00856297|E3|Reported Event|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
550817|NCT00856297|E2|Reported Event|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
550818|NCT00856297|E1|Reported Event|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
550819|NCT00856323|B1|Baseline|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
550820|NCT00856323|P1|Participant Flow|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
550821|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
550822|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
550823|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
550824|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
550825|NCT00856323|E1|Reported Event|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
550826|NCT00856349|B1|Baseline|Analysis Cohort|"Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Therapy Programming Report (TPR): Center-specific therapy programming reports (TPRs) illustrating physician usage of shock reduction programming are provided to each center approximately 9-12 months after their first enrollment and monthly thereafter throughout the study."
550827|NCT00856349|P1|Participant Flow|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward the primary and/or secondary study endpoints.
550828|NCT00856349|O1|Outcome|Subjects With Final Programming Data Available|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.
550829|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
550830|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
550831|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
550832|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
550833|NCT00856349|O1|Outcome|Subjects With Paired Programming Data|Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
550834|NCT00856349|E1|Reported Event|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
550835|NCT00856388|B1|Baseline|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
550836|NCT00856388|P1|Participant Flow|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
550837|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
fludarabine phosphate: Given IV
melphalan: Given IV
total-body irradiation: Undergo total-body irradiation
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
anti-thymocyte globulin: Given IV"
550838|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
550839|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
550840|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
550841|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
550842|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
550843|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
550844|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
550845|NCT00856388|E1|Reported Event|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
fludarabine phosphate: Given IV
melphalan: Given IV
total-body irradiation: Undergo total-body irradiation
allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation
anti-thymocyte globulin: Given IV"
550846|NCT00856414|B1|Baseline|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
550847|NCT00856414|P1|Participant Flow|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
550848|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
550849|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
550850|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
550851|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
550852|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
550853|NCT00856414|E1|Reported Event|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
550854|NCT00856492|B4|Baseline|Total|Total of all reporting groups
550855|NCT00856492|B3|Baseline|Arm 3 (AC+PEG-G / Nab-Paclitaxel)|Received ddAC x 6 first followed by nP x 12, without bevacizumab
550856|NCT00856492|B2|Baseline|Arm 2 (Nab-Paclitaxel / AC+PEG-G))|Received nP x 12 followed by ddAC x 6 without bevacizumab
550857|NCT00856492|B1|Baseline|Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
550858|NCT00856492|P3|Participant Flow|Arm 3 (AC+PEG-G / Nab-Paclitaxel)|ddAC x 6 followed by nP x 12 without bevacizumab
550859|NCT00856492|P2|Participant Flow|Arm 2 (Nab-Paclitaxel / AC+PEG-G)|Received nP x 12 without bevacizumab followed by ddAC x 6
550860|NCT00856492|P1|Participant Flow|Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G))|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
550861|NCT00856492|O3|Outcome|Arm III (AC+PEG-G - Nab-Paclitaxel)|Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
550862|NCT00856492|O2|Outcome|Arm II (Nab-Paclitaxel - AC+PEG-G)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
550863|NCT00856492|O1|Outcome|Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
550864|NCT00856492|O2|Outcome|Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))|Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab
550865|NCT00856492|O1|Outcome|Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
550866|NCT00856492|O2|Outcome|Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))|Arm II received nP x 12 followed by ddAC x 6, and those randomized to Arm III received ddAC x 6 first followed by nP x 12, both without bevacizumab
550867|NCT00856492|O1|Outcome|Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
550868|NCT00856492|O2|Outcome|Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))|Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab
550869|NCT00856492|O1|Outcome|Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
550870|NCT00856492|E3|Reported Event|Arm III (AC+PEG-G - Nab-Paclitaxel)|Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
550871|NCT00856492|E2|Reported Event|Arm II (Nab-Paclitaxel - AC+PEG-G)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
550872|NCT00856492|E1|Reported Event|Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
550873|NCT00856518|B3|Baseline|Total|Total of all reporting groups
550874|NCT00856518|B2|Baseline|Arm 2: Sham Group|Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
550875|NCT00856518|B1|Baseline|Arm 1: EMST|Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
550876|NCT00856518|P2|Participant Flow|Arm 2: Sham Group|"sham group
sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
550877|NCT00856518|P1|Participant Flow|Arm 1: EMST|"Experimental Group
Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
550878|NCT00856518|O2|Outcome|Arm 2: Sham Group|"The sham group undergoes the same 5-week EMST exercise as the experimental group using the same device but without a spring for minimal pressure load
sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
550879|NCT00856518|O1|Outcome|Arm 1: EMST|"The experimental group receives five weeks of expiratory muscle strength training (EMST) using a positive pressure threshold device
Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
550880|NCT00856518|O2|Outcome|Arm 2: Sham|"Sham group
sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
550881|NCT00856518|O1|Outcome|Arm 1: EMST|"EMST Group
Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
550882|NCT00856518|O2|Outcome|Arm 2: Sham|"Sham group
sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
550883|NCT00856518|O1|Outcome|Arm 1: EMST|"EMST Group
Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
550884|NCT00856518|E2|Reported Event|Arm 2: Sham Group|Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
550912|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550885|NCT00856518|E1|Reported Event|Arm 1: EMST|Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
550886|NCT00856544|B5|Baseline|Total|Total of all reporting groups
550887|NCT00856544|B4|Baseline|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550888|NCT00856544|B3|Baseline|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550889|NCT00856544|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550890|NCT00856544|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550891|NCT00856544|P4|Participant Flow|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550892|NCT00856544|P3|Participant Flow|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550893|NCT00856544|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550894|NCT00856544|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550895|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550896|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550897|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550898|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550899|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550900|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550901|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550902|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550903|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550904|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550905|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550906|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550907|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550908|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550909|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550910|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550911|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550913|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550914|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550915|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550916|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550917|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550918|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550919|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550920|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550921|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550922|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550923|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550924|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550925|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550926|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550927|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550928|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550929|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550930|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550931|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550932|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550933|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550934|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550935|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550936|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550937|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550938|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550939|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550940|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550942|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550943|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550944|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550945|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550946|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550947|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550948|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550949|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550950|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550951|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550952|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550953|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550954|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550955|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550956|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550957|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550958|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550959|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550960|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550961|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550962|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550963|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550964|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550965|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550966|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550967|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550968|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550969|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550970|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550971|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550972|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550973|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550974|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550975|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550976|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550977|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550978|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550979|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550980|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550981|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550982|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550983|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550984|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550985|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550986|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550987|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550988|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550989|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
550990|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550991|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550992|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
550993|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
550994|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550995|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550996|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
560078|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
550997|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
550998|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
550999|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
551000|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
551001|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551002|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551003|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
551004|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551005|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551006|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
551007|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
551008|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551009|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551010|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
551011|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
551012|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551013|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551014|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
551015|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
551016|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551017|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551018|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
551019|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551020|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551021|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
551022|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
551023|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551086|NCT00856583|P2|Participant Flow|Risperidone|Normally in the range of 2 to 8 mg/day
551024|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551025|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
551026|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551027|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551028|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
551029|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
551030|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551031|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551032|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
551033|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551034|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551035|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
551036|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
551037|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551038|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551039|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
551040|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551041|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551042|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
551043|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
551044|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551045|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551046|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
551047|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551048|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551049|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
551050|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551051|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551087|NCT00856583|P1|Participant Flow|Sertindole|Normally in the range of 4 to 20 mg/day
551088|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551089|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551052|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
551053|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551054|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551055|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
551056|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
551057|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
551058|NCT00856544|E12|Reported Event|Placebo, Then CP-690,550 10 mg (Post Month 6)|Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 10 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 10 mg tablet twice daily from Month 6 to 12.
551059|NCT00856544|E11|Reported Event|Placebo, Then CP-690,550 5 mg (Post Month 6)|Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 5 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 5 mg tablet twice daily from Month 6 to 12.
551060|NCT00856544|E10|Reported Event|CP-690,550 10 mg (Post Month 6)|CP-690,550 10 mg tablet orally twice daily from Month 6 to 12.
551061|NCT00856544|E9|Reported Event|CP-690,550 5 mg (Post Month 6)|CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
551062|NCT00856544|E8|Reported Event|Placebo, Then CP-690,550 10 mg (Month 3 to 6)|Participants who received matching placebo twice daily up to Month 3, received CP-690,550 10 mg tablet twice daily from Month 3 to 6.
551063|NCT00856544|E7|Reported Event|Placebo, Then CP-690,550 5 mg (Month 3 to 6)|Participants who received matching placebo twice daily up to Month 3, received CP-690,550 5 mg tablet twice daily from Month 3 to 6.
551064|NCT00856544|E6|Reported Event|Placebo (Month 3 to 6)|Matching placebo twice daily from Month 3 to 6.
551065|NCT00856544|E5|Reported Event|CP-690,550 10 mg (Month 3 to 6)|CP-690,550 10 mg tablet twice daily from Month 3 to 6.
551066|NCT00856544|E4|Reported Event|CP-690,550 5 mg (Month 3 to 6)|CP-690,550 5 mg twice daily from Month 3 to 6.
551067|NCT00856544|E3|Reported Event|Placebo (Up To Month 3)|Matching placebo Film-coated tablet orally twice daily up to Month 3.
551068|NCT00856544|E2|Reported Event|CP-690,550 10 mg (Up To Month 3)|CP-690,550 10 mg Film-coated tablet administered orally twice daily up to Month 3.
551069|NCT00856544|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|CP-690,550 5 mg Film-coated tablet administered orally twice daily up to Month 3.
551070|NCT00856557|B3|Baseline|Total|Total of all reporting groups
551071|NCT00856557|B2|Baseline|No Intervention|No educational intervention
551072|NCT00856557|B1|Baseline|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
551073|NCT00856557|P2|Participant Flow|No Intervention|No educational intervention
551074|NCT00856557|P1|Participant Flow|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
551075|NCT00856557|O2|Outcome|No Intervention|No educational intervention
551076|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
551077|NCT00856557|O2|Outcome|No Intervention|No educational intervention
551078|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
551079|NCT00856557|O2|Outcome|No Intervention|No educational intervention
551080|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
551081|NCT00856557|E2|Reported Event|No Intervention|No educational intervention
551082|NCT00856557|E1|Reported Event|Seminar and Practium|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
551083|NCT00856583|B3|Baseline|Total|Total of all reporting groups
551084|NCT00856583|B2|Baseline|Risperidone|Normally in the range of 2 to 8 mg/day
551085|NCT00856583|B1|Baseline|Sertindole|Normally in the range of 4 to 20 mg/day
551090|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551091|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551092|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551093|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551094|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551095|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551096|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551097|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551098|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551099|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551100|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551101|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551102|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551103|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551104|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551105|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551106|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551107|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551108|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551109|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551110|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
551111|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
551112|NCT00856583|E2|Reported Event|Risperidone|Normally in the range of 2 to 8 mg/day
551113|NCT00856583|E1|Reported Event|Sertindole|Normally in the range of 4 to 20 mg/day
551114|NCT00856635|B3|Baseline|Total|Total of all reporting groups
551115|NCT00856635|B2|Baseline|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
551116|NCT00856635|B1|Baseline|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
551117|NCT00856635|P2|Participant Flow|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
551118|NCT00856635|P1|Participant Flow|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
551119|NCT00856635|O2|Outcome|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
551120|NCT00856635|O1|Outcome|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
551121|NCT00856635|E2|Reported Event|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
551122|NCT00856635|E1|Reported Event|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
551123|NCT00856661|B3|Baseline|Total|Total of all reporting groups
551124|NCT00856661|B2|Baseline|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551125|NCT00856661|B1|Baseline|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551126|NCT00856661|P2|Participant Flow|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551127|NCT00856661|P1|Participant Flow|Desmoteplase|90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551128|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551129|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551130|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551131|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551132|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551133|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551134|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551135|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551136|NCT00856661|E2|Reported Event|Desmoteplase|Desmoteplase: 90 ug/kg, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551137|NCT00856661|E1|Reported Event|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
551138|NCT00856739|B4|Baseline|Total|Total of all reporting groups
551139|NCT00856739|B3|Baseline|Obese|Body mass index between 30 and 50 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
551140|NCT00856739|B2|Baseline|Overweight|Body mass index between 25 and 30 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
551141|NCT00856739|B1|Baseline|Normal Weight|Body mass index between 18 and 25 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
551142|NCT00856739|P3|Participant Flow|Obese|Body mass index over 30 kg/m^2
551143|NCT00856739|P2|Participant Flow|Overweight|Body mass index between 25 and 30 kg/m^2
551144|NCT00856739|P1|Participant Flow|Normal Weight|Body mass index between 18 and 25 kg/m^2
551145|NCT00856739|O4|Outcome|Overweight and Obese Middle Age|Body mass index between 27 and 50 kg/m^2, age between 35 and 60
551146|NCT00856739|O3|Outcome|Normal Weight Middle Age|Body mass index between 18 and 25 kg/m^2, age between 35 and 60
551147|NCT00856739|O2|Outcome|Overweight and Obese Young|Body mass index between 27 and 50 kg/m^2, age between 20 and 35
551148|NCT00856739|O1|Outcome|Normal Weight Young|Body mass index between 18 and 25 kg/m^2, age between 20 and 35
560079|NCT00882687|O4|Outcome|Placebo|
551149|NCT00856739|O2|Outcome|Obese|Body mass index between 30 and 50 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
551150|NCT00856739|O1|Outcome|Normal Weight|Body mass index between 18 and 25 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
551151|NCT00856739|E3|Reported Event|Obese|Body mass index between 30 and 50 kg/m^2
551152|NCT00856739|E2|Reported Event|Overweight|Body mass index between 25 and 30 kg/m^2
551153|NCT00856739|E1|Reported Event|Normal Weight|Body mass index between 18 and 25 kg/m^2
551154|NCT00856778|B1|Baseline|Subjects Implanted With Virtue® Male Sling|The Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
551155|NCT00856778|P1|Participant Flow|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551156|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551157|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551158|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551159|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551160|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551161|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551162|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551163|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551164|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551165|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551166|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551167|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551168|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
551169|NCT00856778|E1|Reported Event|Subjects Implanted With Virtue® Male Sling|The Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
551170|NCT00856791|B1|Baseline|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
551171|NCT00856791|P1|Participant Flow|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
551172|NCT00856791|O1|Outcome|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
551173|NCT00856791|O1|Outcome|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
551174|NCT00856791|E1|Reported Event|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
551175|NCT00856830|B5|Baseline|Total|Total of all reporting groups
551176|NCT00856830|B4|Baseline|Regimen A: Cohort IV Bendamustine 100 -120 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. Bendamustine was given at 100 - 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
551177|NCT00856830|B3|Baseline|Regimen A: Cohort III Bendamustine 120 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. The initial dose of bendamustine was 120 mg/m2 with incremental 20 mg/m2 dose escalation to a maximum of 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
551178|NCT00856830|B2|Baseline|Regimen A: Cohort II Bendamustine 100 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. The initial dose of bendamustine was 100 mg/m2 with incremental 20 mg/m2 dose escalation to a maximum of 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
551179|NCT00856830|B1|Baseline|Regimen A: Cohort I Bendamustine 80 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. The initial dose of bendamustine was 80 mg/m2 with incremental 20 mg/m2 dose escalation to a maximum of 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
551180|NCT00856830|P4|Participant Flow|Phase II - Regimen A: Cohort IV (B) 100 -120 mg/m2 (Day 1,2)|"Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at bendamustine 100-120 mg/m2 (Day 1,2). This was repeated every 21 days for a total of 3 cycles.
Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles."
551181|NCT00856830|P3|Participant Flow|Phase I - Regimen A: Cohort III (120 mg/M2) - (B)|"Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendamustine (120 mg/m2) on days 1 and 2: every 21 days for a total of 3 cycles.
Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles."
551182|NCT00856830|P2|Participant Flow|Phase I - Regimen A: Cohort II 100mg/m2) - (B)|"Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendamustine (100 mg/m2) on days 1 and 2: every 21 days for a total of 3 cycles.
Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles."
551183|NCT00856830|P1|Participant Flow|Phase I - Regimen A: Cohort I (80 mg/m2) - Bendamustine (B)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendamustine (80 mg/m2) on days 1 and 2: every 21 days for a total of 3 cycles Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles.
551184|NCT00856830|O1|Outcome|Novel Drug Combination|"This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin.
This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.
Novel Drug Combination: This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.
•All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging."
551185|NCT00856830|O1|Outcome|Novel Drug Combination|"This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin.
This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.
Novel Drug Combination: This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.
•All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging."
551186|NCT00856830|O1|Outcome|Novel Drug Combination|"There is only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.
Bendamustine, Irinotecan, Etoposide/Carboplatin (Novel drug combination): Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.
All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging.
At the end (3 weeks after) of the sixth total round of chemotherapy, subjects will be re-evaluated for response, and will be followed"
551187|NCT00856830|E1|Reported Event|Novel Drug Combination|"This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin.This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.
Novel Drug Combination: This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.
•All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging."
551188|NCT00856843|B3|Baseline|Total|Total of all reporting groups
551189|NCT00856843|B2|Baseline|BLI800|Investigational prep - oral solution, 1 administration
551190|NCT00856843|B1|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551191|NCT00856843|P2|Participant Flow|BLI800|Investigational prep - oral solution, 1 administration
551192|NCT00856843|P1|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551193|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551194|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551195|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551196|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551197|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551198|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551199|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551200|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551201|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551202|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551203|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551204|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551205|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551206|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551207|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551208|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551209|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551210|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551211|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551212|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551213|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551214|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551215|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551216|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551217|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551218|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551219|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
551220|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551221|NCT00856843|E2|Reported Event|BLI800|Investigational prep - oral solution, 1 administration
551222|NCT00856843|E1|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
551223|NCT00856908|B3|Baseline|Total|Total of all reporting groups
551224|NCT00856908|B2|Baseline|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551225|NCT00856908|B1|Baseline|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551226|NCT00856908|P2|Participant Flow|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551227|NCT00856908|P1|Participant Flow|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551228|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551229|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551230|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551231|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551232|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551233|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551234|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551235|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551236|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551237|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
560080|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
551238|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551239|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551240|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551241|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551242|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551243|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551244|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551245|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551246|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551247|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551248|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551249|NCT00856908|E2|Reported Event|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551250|NCT00856908|E1|Reported Event|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
551251|NCT00856934|B4|Baseline|Total|Total of all reporting groups
551252|NCT00856934|B3|Baseline|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
551253|NCT00856934|B2|Baseline|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
551254|NCT00856934|B1|Baseline|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
551255|NCT00856934|P3|Participant Flow|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
551256|NCT00856934|P2|Participant Flow|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
551257|NCT00856934|P1|Participant Flow|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
551258|NCT00856934|O3|Outcome|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
551259|NCT00856934|O2|Outcome|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
551260|NCT00856934|O1|Outcome|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
551261|NCT00856934|O3|Outcome|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
551262|NCT00856934|O2|Outcome|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
551263|NCT00856934|O1|Outcome|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
551264|NCT00856973|B4|Baseline|Total|Total of all reporting groups
551265|NCT00856973|B3|Baseline|Placebo|Placebo Once Daily. This included only patients that were randomized (ITT population).
551266|NCT00856973|B2|Baseline|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily. This includes only patients that were randomized (ITT population).
551267|NCT00856973|B1|Baseline|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily. This included only patients that were randomized (ITT population).
551268|NCT00856973|P3|Participant Flow|Placebo|Placebo 6-17 years
551269|NCT00856973|P2|Participant Flow|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551270|NCT00856973|P1|Participant Flow|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551271|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551272|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551273|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551274|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551275|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551276|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551277|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551278|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551279|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551280|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551281|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551282|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551283|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551284|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551285|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551286|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551287|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551288|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551289|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551290|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551291|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551292|NCT00856973|O3|Outcome|Placebo|Placebo once daily
551293|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily
551294|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily
551295|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551296|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551297|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551298|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551299|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551300|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551301|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551302|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551303|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551304|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551305|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551306|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551307|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551308|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551309|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551310|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551311|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551312|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551313|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551314|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551315|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551316|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551317|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551318|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551319|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551320|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551321|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551322|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551323|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551324|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551325|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
551326|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551327|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551328|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years
551329|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551330|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551331|NCT00856973|E3|Reported Event|Placebo|Placebo 6-17 years once daily
551332|NCT00856973|E2|Reported Event|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
551333|NCT00856973|E1|Reported Event|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
551334|NCT00856986|B6|Baseline|Total|Total of all reporting groups
551335|NCT00856986|B5|Baseline|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551563|NCT00857272|B1|Baseline|HalfLytely With 5mg Bisacodyl|Investigational dose
551564|NCT00857272|P2|Participant Flow|HalfLytely With 10mg Bisacodyl|Active Control
551565|NCT00857272|P1|Participant Flow|HalfLytely With 5mg Bisacodyl|Investigational dose
551566|NCT00857272|O2|Outcome|HalfLytely With 10mg Bisacodyl|Active Control
551336|NCT00856986|B4|Baseline|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551337|NCT00856986|B3|Baseline|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551338|NCT00856986|B2|Baseline|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551339|NCT00856986|B1|Baseline|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551340|NCT00856986|P5|Participant Flow|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551341|NCT00856986|P4|Participant Flow|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551342|NCT00856986|P3|Participant Flow|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551343|NCT00856986|P2|Participant Flow|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551344|NCT00856986|P1|Participant Flow|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551345|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551346|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551347|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551348|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551349|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551350|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551567|NCT00857272|O1|Outcome|HalfLytely With 5mg Bisacodyl|Investigational dose
551568|NCT00857272|E2|Reported Event|HalfLytely With 10mg Bisacodyl|Active Control
551351|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551352|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551353|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551354|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551355|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551356|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551357|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551358|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551359|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551360|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551361|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551362|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551363|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551364|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551365|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551569|NCT00857272|E1|Reported Event|HalfLytely With 5mg Bisacodyl|Investigational dose
551570|NCT00857285|B3|Baseline|Total|Total of all reporting groups
551571|NCT00857285|B2|Baseline|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
551366|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551367|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551368|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551369|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551370|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551371|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551372|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551373|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551374|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551375|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551376|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551377|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551378|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551379|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551380|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551572|NCT00857285|B1|Baseline|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
551573|NCT00857285|P2|Participant Flow|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
551381|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551382|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551383|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551384|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551385|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551386|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551387|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551388|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551389|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551390|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551391|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551392|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551393|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551394|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551395|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551574|NCT00857285|P1|Participant Flow|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
551575|NCT00857285|O2|Outcome|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
551396|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551397|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551398|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551399|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551400|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551401|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551402|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551403|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551404|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551405|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551406|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551407|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551408|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551409|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551410|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551576|NCT00857285|O1|Outcome|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
551577|NCT00857311|B5|Baseline|Total|Total of all reporting groups
560081|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
551411|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551412|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551413|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551414|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551415|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551416|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551417|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551418|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551419|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551420|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551421|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551422|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551423|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551424|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551425|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551614|NCT00857454|E1|Reported Event|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
551615|NCT00857506|B4|Baseline|Total|Total of all reporting groups
551616|NCT00857506|B3|Baseline|Cognitively Normal|
551426|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551427|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551428|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551429|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551430|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551431|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551432|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551433|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551434|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551435|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551436|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551437|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551438|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551439|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551440|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551617|NCT00857506|B2|Baseline|Mild Cognitive Impairment|
551618|NCT00857506|B1|Baseline|Alzheimer's Disease|
551709|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
551441|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551442|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551443|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551444|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551445|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551446|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551447|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551448|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551449|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551450|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551451|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551452|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551453|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551454|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551455|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551661|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551710|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
551456|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551457|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551458|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551459|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551460|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551461|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551462|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551463|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551464|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551465|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551466|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551467|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551468|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551469|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551470|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551662|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
560082|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
551471|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551472|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551473|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551474|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551475|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551476|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551477|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551478|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551479|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551480|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551481|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551482|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551483|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551484|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551485|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551663|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551711|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
551486|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551487|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551488|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551489|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551490|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551491|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551492|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551493|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551494|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551495|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551496|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551497|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551498|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551499|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551500|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551664|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551712|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
551501|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551502|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551503|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551504|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551505|NCT00856986|E5|Reported Event|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
551506|NCT00856986|E4|Reported Event|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
551507|NCT00856986|E3|Reported Event|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
551508|NCT00856986|E2|Reported Event|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551509|NCT00856986|E1|Reported Event|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
551510|NCT00857220|B1|Baseline|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551511|NCT00857220|P1|Participant Flow|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551512|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551513|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551514|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551515|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551516|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551517|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551518|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551519|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551520|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551521|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551522|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551523|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551524|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551525|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551526|NCT00857220|E1|Reported Event|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
551527|NCT00857233|B1|Baseline|Memantine|20 mg Oral Tablets Once Daily
551528|NCT00857233|P1|Participant Flow|Memantine|20 mg Oral Tablets Once Daily
551529|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
551530|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
551531|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
551532|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
551533|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
551534|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
551535|NCT00857233|E1|Reported Event|Memantine|20 mg Oral Tablets Once Daily
551536|NCT00857246|B1|Baseline|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
Surgery (3-4 weeks after induction treatment).
Chemoradiation treatment (4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
551537|NCT00857246|P1|Participant Flow|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
Surgery (starts 3-4 weeks after induction treatment).
Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
551538|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
Surgery (starts 3-4 weeks after induction treatment).
Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
551539|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
Surgery (starts 3-4 weeks after induction treatment).
Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
551540|NCT00857246|O1|Outcome|Induction Treatment|Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
551541|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
Surgery (3-4 weeks after induction treatment).
Chemoradiation treatment (4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
551542|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
Surgery (starts 3-4 weeks after induction treatment).
Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
551543|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
Surgery (starts 3-4 weeks after induction treatment).
Chemoradiation treatment ( starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
551544|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
Surgery (starts 3-4 weeks after induction treatment).
Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
551545|NCT00857246|E1|Reported Event|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
Surgery (starts 3-4 weeks after induction treatment).
Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
551546|NCT00857259|B4|Baseline|Total|Total of all reporting groups
551547|NCT00857259|B3|Baseline|Everolimus and Ranibizumab|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
551548|NCT00857259|B2|Baseline|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
551549|NCT00857259|B1|Baseline|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
551550|NCT00857259|P3|Participant Flow|Everolimus and Ranibizumab|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
551551|NCT00857259|P2|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
551552|NCT00857259|P1|Participant Flow|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
551553|NCT00857259|O3|Outcome|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
551554|NCT00857259|O2|Outcome|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (Baseline)
551555|NCT00857259|O1|Outcome|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
551556|NCT00857259|O3|Outcome|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
551557|NCT00857259|O2|Outcome|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy 0.5 mg on Day 1 (baseline)
551558|NCT00857259|O1|Outcome|Oral Everolimus 5 mg|5 mg once daily plus sham ocular injection on Day 1 (Baseline)
551559|NCT00857259|E2|Reported Event|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
551560|NCT00857259|E1|Reported Event|Oral Everolimus 5 mg|5 mg once daily plus sham ocular injection on Day 1 (Baseline)
551561|NCT00857272|B3|Baseline|Total|Total of all reporting groups
551562|NCT00857272|B2|Baseline|HalfLytely With 10mg Bisacodyl|Active Control
551578|NCT00857311|B4|Baseline|Open Label Tetanus and Diptheria Toxoids Adsorbed|"Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only.
Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group."
551579|NCT00857311|B3|Baseline|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
551580|NCT00857311|B2|Baseline|MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose|"Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.
Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose."
551581|NCT00857311|B1|Baseline|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
551582|NCT00857311|P4|Participant Flow|Open Label Tetanus and Diptheria Toxoids Adsorbed|"Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only.
Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group."
551583|NCT00857311|P3|Participant Flow|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
551584|NCT00857311|P2|Participant Flow|MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose|"Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.
Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose."
551585|NCT00857311|P1|Participant Flow|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
551586|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
551587|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
551588|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
551589|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
551590|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
551591|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
551592|NCT00857311|E2|Reported Event|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
551593|NCT00857311|E1|Reported Event|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
551594|NCT00857415|B3|Baseline|Total|Total of all reporting groups
551595|NCT00857415|B2|Baseline|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
551596|NCT00857415|B1|Baseline|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
551597|NCT00857415|P2|Participant Flow|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
551598|NCT00857415|P1|Participant Flow|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
551599|NCT00857415|O1|Outcome|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy
551600|NCT00857415|O1|Outcome|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques
551601|NCT00857415|O1|Outcome|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy
551602|NCT00857415|E2|Reported Event|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
551603|NCT00857415|E1|Reported Event|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
551604|NCT00857454|B1|Baseline|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
551605|NCT00857454|P1|Participant Flow|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
551606|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
551607|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
551608|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
551609|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
551610|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
551611|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
551612|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
551613|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
551707|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
551619|NCT00857506|P3|Participant Flow|Cognitively Normal|Cognitively Normal (CN) subjects were recruited from study 18F-AV-45-A05 (NCT00702143). 50 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
551620|NCT00857506|P2|Participant Flow|Mild Cognitive Impairment|Subject's with Mild Cognitive Impairment (MCI) were recruited from study 18F-AV-45-A05 (NCT00702143). 36 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
551621|NCT00857506|P1|Participant Flow|Alzheimer's Disease|Subject's with Alzheimer's Disease were recruited from study 18F-AV-45-A05 (NCT00702143). None of these subjects received additional interventions in study 18F-AV-45-A11.
551622|NCT00857506|O3|Outcome|Cognitively Normal|Subjects with a baseline clinical diagnosis of CN.
551623|NCT00857506|O2|Outcome|Mild Cognitive Impairment|Subjects with a baseline clinical diagnosis of MCI.
551624|NCT00857506|O1|Outcome|Alzheimer's Disease|Subjects with a baseline clinical diagnosis of AD.
551625|NCT00857506|O6|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
551626|NCT00857506|O5|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
551627|NCT00857506|O4|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
551628|NCT00857506|O3|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
551629|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline. All assessments were obtained for 57 subjects except for CDR-SOB and ADCS ADL which were obtained for 55 and 56 subjects respectively.
551630|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
551631|NCT00857506|O4|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
551632|NCT00857506|O3|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
551633|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline. 57 subjects were analyzed for change in ADAS-Cog and 55 subjects were analyzed for change in CDR.
551634|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
551635|NCT00857506|O4|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
551636|NCT00857506|O3|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
551637|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline.
551638|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
551639|NCT00857506|O2|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
551640|NCT00857506|O1|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
551641|NCT00857506|O2|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
551642|NCT00857506|O1|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
551643|NCT00857506|E3|Reported Event|Cognitively Normal|
551644|NCT00857506|E2|Reported Event|Mild Cognitive Impairment|
551645|NCT00857506|E1|Reported Event|Alzheimer's Disease|
551646|NCT00857532|B1|Baseline|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
551647|NCT00857532|P1|Participant Flow|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 megabecquerel (MBq) injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
551648|NCT00857532|O1|Outcome|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir followed by a 10 minute PET scan 50 minutes post-injections
551649|NCT00857532|O1|Outcome|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir followed by a 10 minute PET scan 50 minutes post-injections
551650|NCT00857532|O3|Outcome|Subjects With Moderate to Severe Cognitive Impairment|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score 5 and below.
551651|NCT00857532|O2|Outcome|Subjects With Mild Cognitive Deficits|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score between 6 and 8 inclusive.
551652|NCT00857532|O1|Outcome|Subjects With Normal Cognitive Performance|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score greater than or equal to 9.
551653|NCT00857532|E1|Reported Event|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
551654|NCT00857584|B3|Baseline|Total|Total of all reporting groups
551655|NCT00857584|B2|Baseline|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551656|NCT00857584|B1|Baseline|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551657|NCT00857584|P2|Participant Flow|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551658|NCT00857584|P1|Participant Flow|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551659|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551660|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551665|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551666|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551667|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551668|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551669|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551670|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551671|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551672|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551673|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551674|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551675|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551676|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551677|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551678|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551679|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551680|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551681|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551682|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551683|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551684|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551685|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551686|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551687|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551688|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551689|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551690|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551691|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551692|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551693|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551694|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551695|NCT00857584|E2|Reported Event|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
551696|NCT00857584|E1|Reported Event|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
551697|NCT00857623|B3|Baseline|Total|Total of all reporting groups
551698|NCT00857623|B2|Baseline|Placebo|Capsule, once daily
551699|NCT00857623|B1|Baseline|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
551700|NCT00857623|P2|Participant Flow|Placebo|Capsule, once daily
551701|NCT00857623|P1|Participant Flow|AZD2066|Capsule, once daily. 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
551702|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
551703|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
551704|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
551705|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
551706|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
551713|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
551714|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
551715|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
551716|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
551717|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
551718|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
551719|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
551720|NCT00857623|E2|Reported Event|Placebo|Capsule, once daily
551721|NCT00857623|E1|Reported Event|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
551722|NCT00857649|B3|Baseline|Total|Total of all reporting groups
551723|NCT00857649|B2|Baseline|Placebo|Oral Tablets Once Daily
551724|NCT00857649|B1|Baseline|Memantine|20 mg Oral Tablets Once Daily
551725|NCT00857649|P2|Participant Flow|Placebo|Oral Tablets Once Daily
551726|NCT00857649|P1|Participant Flow|Memantine|20 mg Oral Tablets Once Daily
551727|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
551728|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
551729|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
551730|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
551731|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
551732|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
551733|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
551734|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
551735|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
551736|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
551737|NCT00857649|E2|Reported Event|Placebo|Oral Tablets Once Daily
551738|NCT00857649|E1|Reported Event|Memantine|20 mg Oral Tablets Once Daily
551739|NCT00857714|B1|Baseline|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
551740|NCT00857714|P1|Participant Flow|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
551741|NCT00857714|O1|Outcome|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
551742|NCT00857714|O1|Outcome|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
551743|NCT00857714|E1|Reported Event|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
551744|NCT00857766|B3|Baseline|Total|Total of all reporting groups
551745|NCT00857766|B2|Baseline|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551746|NCT00857766|B1|Baseline|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551747|NCT00857766|P2|Participant Flow|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551748|NCT00857766|P1|Participant Flow|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551749|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551750|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551751|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551752|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551753|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551754|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551755|NCT00857766|E2|Reported Event|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551756|NCT00857766|E1|Reported Event|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
551757|NCT00857792|B1|Baseline|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
551758|NCT00857792|P1|Participant Flow|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
551759|NCT00857792|O1|Outcome|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
551760|NCT00857792|E1|Reported Event|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
551761|NCT00857818|B3|Baseline|Total|Total of all reporting groups
551762|NCT00857818|B2|Baseline|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
552095|NCT00852527|O2|Outcome|Veterans Assessed With the Structured TBI Diagnostic Interview|
551763|NCT00857818|B1|Baseline|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551764|NCT00857818|P2|Participant Flow|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551765|NCT00857818|P1|Participant Flow|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551766|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551767|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551768|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551769|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551770|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551771|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551772|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551773|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551774|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551775|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551776|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551777|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551778|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551779|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551780|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551781|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551782|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551783|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551784|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551785|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551786|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551787|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551788|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551789|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551790|NCT00857818|E2|Reported Event|CONTROL GROUP|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
551791|NCT00857818|E1|Reported Event|ARIPIPRAZOLE|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
551792|NCT00857896|B1|Baseline|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
551793|NCT00857896|P1|Participant Flow|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
551794|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
552096|NCT00852527|O1|Outcome|Veterans Assessed With the Comprehensive TBI Evaluation|
551795|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
551796|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
551797|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
551798|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
551799|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
551800|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
551801|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
551802|NCT00857896|E2|Reported Event|Fesoterodine 8 mg|Fesoterodine 8 mg tablet QD anytime during the study
551803|NCT00857896|E1|Reported Event|Fesoterodine 4 mg|Fesoterodine 4 mg tablet QD anytime during the study
551804|NCT00857948|B5|Baseline|Total|Total of all reporting groups
551805|NCT00857948|B4|Baseline|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
551806|NCT00857948|B3|Baseline|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
551807|NCT00857948|B2|Baseline|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
551808|NCT00857948|B1|Baseline|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
551809|NCT00857948|P4|Participant Flow|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
551810|NCT00857948|P3|Participant Flow|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
551811|NCT00857948|P2|Participant Flow|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
551812|NCT00857948|P1|Participant Flow|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
551813|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
551814|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
551815|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
551816|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
551817|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
551818|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
551819|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
551820|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
551821|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
551822|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
551823|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
551824|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
551825|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
551826|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
551827|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
551828|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
551829|NCT00857948|E4|Reported Event|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
551830|NCT00857948|E3|Reported Event|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
551831|NCT00857948|E2|Reported Event|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
551832|NCT00857948|E1|Reported Event|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
551833|NCT00857961|B1|Baseline|Testosterone MD-Lotion|"Applied once daily for 7 days.
All study participants received each of the 4 study treatments:
3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).
1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.
3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).
4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla)."
551834|NCT00857961|P1|Participant Flow|Testosterone MD-Lotion|"Applied once daily for 7 days.
All study participants received each of the 4 study treatments:
3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).
1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.
3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).
4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla)."
551835|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
551836|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551837|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
551838|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551839|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
551840|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551841|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
551842|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551843|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
551844|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551845|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
551846|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551847|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
551848|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551849|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
551850|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551851|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
551852|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551853|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
551854|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551855|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
551856|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551857|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
551858|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551859|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
551860|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551861|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
551862|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551863|NCT00857961|E4|Reported Event|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
551864|NCT00857961|E3|Reported Event|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551865|NCT00857961|E2|Reported Event|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
551866|NCT00857961|E1|Reported Event|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
551867|NCT00858013|B3|Baseline|Total|Total of all reporting groups
551868|NCT00858013|B2|Baseline|Glimepiride|"Glimepiride 1~2mg once a day
Glimepiride: Glimepiride 1~2mg once a day"
551869|NCT00858013|B1|Baseline|Nateglinide|"Nateglinide 90~120mg three times a day
Nateglinide: Nateglinide 90~120mg three times a day"
551870|NCT00858013|P2|Participant Flow|Glimepiride|"Glimepiride 1~2mg once a day
Glimepiride: Glimepiride 1~2mg once a day"
551871|NCT00858013|P1|Participant Flow|Nateglinide|"Nateglinide 90~120mg three times a day
Nateglinide: Nateglinide 90~120mg three times a day"
551872|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day
Glimepiride: Glimepiride 1~2mg once a day"
551873|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day
Nateglinide: Nateglinide 90~120mg three times a day"
551874|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day
Glimepiride: Glimepiride 1~2mg once a day"
551875|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day
Nateglinide: Nateglinide 90~120mg three times a day"
551876|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day
Glimepiride: Glimepiride 1~2mg once a day"
551877|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day
Nateglinide: Nateglinide 90~120mg three times a day"
551878|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day
Glimepiride: Glimepiride 1~2mg once a day"
551879|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day
Nateglinide: Nateglinide 90~120mg three times a day"
551880|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day
Glimepiride: Glimepiride 1~2mg once a day"
551881|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day
Nateglinide: Nateglinide 90~120mg three times a day"
551882|NCT00858013|E2|Reported Event|Glimepiride|"Glimepiride 1~2mg once a day
Glimepiride: Glimepiride 1~2mg once a day"
551883|NCT00858013|E1|Reported Event|Nateglinide|"Nateglinide 90~120mg three times a day
Nateglinide: Nateglinide 90~120mg three times a day"
551884|NCT00858143|B1|Baseline|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
552097|NCT00852527|E1|Reported Event|OEF/OIF Veterans|No adverse events.
551885|NCT00858143|P1|Participant Flow|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551886|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551887|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551888|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551889|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551890|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551891|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551892|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551893|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551894|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551895|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551896|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551897|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551898|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551899|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551900|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551901|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551902|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551903|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551904|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551905|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551906|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551907|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551908|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551909|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551910|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551911|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551912|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551913|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551914|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551915|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551916|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551917|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551918|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551919|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551920|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551921|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551922|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551923|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551924|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551925|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551926|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551927|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551928|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551929|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551930|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551931|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551932|NCT00858143|E1|Reported Event|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
551933|NCT00858208|B1|Baseline|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551934|NCT00858208|P1|Participant Flow|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551935|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551936|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
552098|NCT00852540|B3|Baseline|Total|Total of all reporting groups
551937|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551938|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551939|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551940|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551941|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551942|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551943|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551944|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551945|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551946|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551947|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551948|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551949|NCT00858208|E1|Reported Event|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
551950|NCT00858247|B3|Baseline|Total|Total of all reporting groups
551951|NCT00858247|B2|Baseline|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily
551952|NCT00858247|B1|Baseline|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily
551953|NCT00858247|P2|Participant Flow|Vitamin D3-high Dose|"Vitamin D3 2000 IU capsule, one capsule daily
Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks."
551954|NCT00858247|P1|Participant Flow|Vitamin D3-low Dose|"Vitamin D3 400 IU capsule, one capsule daily
Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks."
551955|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
551956|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
551957|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
551958|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
551959|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
551960|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
551961|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
551962|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
551963|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
551964|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
551965|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
551966|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
551967|NCT00858247|E2|Reported Event|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
551968|NCT00858247|E1|Reported Event|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
551969|NCT00858390|B3|Baseline|Total|Total of all reporting groups
551970|NCT00858390|B2|Baseline|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
551971|NCT00858390|B1|Baseline|1 Standard Care|18 organ donors receiving standard care
551972|NCT00858390|P2|Participant Flow|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
551973|NCT00858390|P1|Participant Flow|1 Standard Care|18 organ donors receiving standard care
552774|NCT00859638|B2|Baseline|Case Matched Controls|Usual care in primary health care.
551974|NCT00858390|O2|Outcome|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
551975|NCT00858390|O1|Outcome|1 Standard Care|18 organ donors receiving standard care
551976|NCT00858390|E2|Reported Event|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
551977|NCT00858390|E1|Reported Event|1 Standard Care|18 organ donors receiving standard care
551978|NCT00858403|B1|Baseline|Treatment With Dasatinib|
551979|NCT00858403|P1|Participant Flow|Treatment With Dasatinib|
551980|NCT00858403|O1|Outcome|Treatment With Dasatinib|
551981|NCT00858403|O1|Outcome|Treatment With Dasatinib|
551982|NCT00858403|O1|Outcome|Treatment With Dasatinib|
551983|NCT00858403|O1|Outcome|Treatment With Dasatinib|
551984|NCT00858403|O1|Outcome|Treatment With Dasatinib|
551985|NCT00858403|O1|Outcome|Treatment With Dasatinib|
551986|NCT00858403|O1|Outcome|Treatment With Dasatinib|
551987|NCT00858403|E1|Reported Event|Treatment With Dasatinib|
551988|NCT00858442|B3|Baseline|Total|Total of all reporting groups
551989|NCT00858442|B2|Baseline|With PRP|Patients with burns sequelae on their limbs treated with release of burn contractures and skin graft with PRP between 2008-2010.
551990|NCT00858442|B1|Baseline|Without PRP|Patients with burns sequelae on their limbs treated with release of burns contractures and skin graft between 2008-2010.
551991|NCT00858442|P2|Participant Flow|With PRP|4 cc of PRP is evenly distributed before the dermo-epidermic draft.
551992|NCT00858442|P1|Participant Flow|Without PRP|This arm did not receive any intervention
551993|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
551994|NCT00858442|O1|Outcome|Without PRP|Patients did not receive plasma enriched platelets
551995|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
551996|NCT00858442|O1|Outcome|Without PRP|Patients did not receive plasma enriched platelets
551997|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
551998|NCT00858442|O1|Outcome|Without PRP|Patients did not received plasma enrich platelets
551999|NCT00858442|E2|Reported Event|With PRP|Patients received plasma enriched platelets
552000|NCT00858442|E1|Reported Event|Without PRP|Patients did not receive plasma enriched platelets
552001|NCT00858468|B3|Baseline|Total|Total of all reporting groups
552002|NCT00858468|B2|Baseline|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
552003|NCT00858468|B1|Baseline|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
552004|NCT00858468|P2|Participant Flow|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
552005|NCT00858468|P1|Participant Flow|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
552006|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
552007|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
552008|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
552009|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
552010|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
552011|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
552012|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
552013|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
552014|NCT00858468|E2|Reported Event|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
552015|NCT00858468|E1|Reported Event|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
552016|NCT00858494|B1|Baseline|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
552017|NCT00858494|P1|Participant Flow|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
552018|NCT00858494|O1|Outcome|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
552019|NCT00858494|O1|Outcome|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
552020|NCT00858494|E1|Reported Event|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
552021|NCT00858507|B3|Baseline|Total|Total of all reporting groups
552022|NCT00858507|B2|Baseline|Arm 2: Social Work Based Outreach (Usual Care)|"Social work based outreach (usual care)
Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
552023|NCT00858507|B1|Baseline|Arm 1: RN-based Medical Outreach, Administration of a Personal|"RN-based medical outreach, administration of a personal health assessment and brief intervention
Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
552024|NCT00858507|P2|Participant Flow|Arm 2: Social Work Based Outreach (Usual Care)|"Social work based outreach (usual care)
Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
552025|NCT00858507|P1|Participant Flow|Arm 1: RN-based Medical Outreach, Administration of a Personal|"RN-based medical outreach, administration of a personal health assessment and brief intervention
Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
552026|NCT00858507|O2|Outcome|Arm 2: Usual Care|"Social work based outreach (usual care)
Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
552056|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
560083|NCT00882687|O4|Outcome|Placebo|
552027|NCT00858507|O1|Outcome|Arm 1: Outreach|"RN-based medical outreach, administration of a personal health assessment and brief intervention
Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
552028|NCT00858507|E2|Reported Event|Arm 2: Usual Care|"Social work based outreach (usual care)
Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
552029|NCT00858507|E1|Reported Event|Arm 1: Outreach|"RN-based medical outreach, administration of a personal health assessment and brief intervention
Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
552030|NCT00858637|B3|Baseline|Total|Total of all reporting groups
552031|NCT00858637|B2|Baseline|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|"Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
There was a gap of 2 subject between STARTED and Overall Number of Baseline Participants.
One subject did not take any study medication and excluded from Baseline Participants.
In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
552032|NCT00858637|B1|Baseline|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|"Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants.
One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
552033|NCT00858637|P6|Participant Flow|Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
552034|NCT00858637|P5|Participant Flow|Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
552035|NCT00858637|P4|Participant Flow|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|"Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
There was a gap of 2 subject between STARTED and Overall Number of Baseline Participants.
One subject did not take any study medication and excluded from Baseline Participants.
In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
552036|NCT00858637|P3|Participant Flow|MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
552037|NCT00858637|P2|Participant Flow|MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
552038|NCT00858637|P1|Participant Flow|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|"Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants.
One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
552039|NCT00858637|O2|Outcome|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|Active Comparison Phase: 10 mg to 40 mgof Simvastatin / day as titrated
552040|NCT00858637|O1|Outcome|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
552041|NCT00858637|O4|Outcome|Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
552042|NCT00858637|O3|Outcome|Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
552043|NCT00858637|O2|Outcome|MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
552044|NCT00858637|O1|Outcome|MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
552045|NCT00858637|E2|Reported Event|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
552046|NCT00858637|E1|Reported Event|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
552047|NCT00852397|B4|Baseline|Total|Total of all reporting groups
552048|NCT00852397|B3|Baseline|Apixaban 5.0 mg BID|"Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Number of participants in baseline characteristics means randomized participants."
552049|NCT00852397|B2|Baseline|Apixaban 2.5 mg BID|"2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Number of participants in baseline characteristics means randomized participants."
552050|NCT00852397|B1|Baseline|Placebo|"Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Number of participants in baseline characteristics means randomized participants."
552051|NCT00852397|P3|Participant Flow|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552052|NCT00852397|P2|Participant Flow|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552053|NCT00852397|P1|Participant Flow|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552054|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552055|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552057|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552058|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552059|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552060|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552061|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552062|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552063|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552064|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552065|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552066|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552067|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552068|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552069|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552070|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552071|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552072|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552073|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552074|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552075|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552076|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552077|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552078|NCT00852397|E3|Reported Event|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552079|NCT00852397|E2|Reported Event|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552080|NCT00852397|E1|Reported Event|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
552081|NCT00852475|B3|Baseline|Total|Total of all reporting groups
552082|NCT00852475|B2|Baseline|PUFA|"Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program
PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
552083|NCT00852475|B1|Baseline|MUFA|"Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program
MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program"
552084|NCT00852475|P2|Participant Flow|PUFA|"Assignment to polyunsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the PUFA MOVE! program
PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
552085|NCT00852475|P1|Participant Flow|MUFA|"Assignment to monounsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the MUFA MOVE! program
MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE! diet and exercise program"
552086|NCT00852475|O2|Outcome|PUFA Arm|Assessment of FMD after 6 months of PUFA enrichment
552087|NCT00852475|O1|Outcome|MUFA Arm|Assessment of FMD after six months of MUFA enrichment
552088|NCT00852475|O2|Outcome|PUFA|"Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program
PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
552089|NCT00852475|O1|Outcome|MUFA|"Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program
MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program"
552090|NCT00852475|E2|Reported Event|PUFA|subjects received a diet enriched in PUFA
552091|NCT00852475|E1|Reported Event|MUFA|subjects received a diet enriched in MUFA
552092|NCT00852527|B1|Baseline|OEF/OIF Veterans|Operation Enduring Freedom /Operation Iraqi Freedom (OEF/OIF) Veterans seeking care at one of three VA Polytrauma Network Sites (PNS) who screen positive or negative for mild traumatic brain injury.
552093|NCT00852527|P2|Participant Flow|Negative Mild TBI|Participants who screened negative on the TBI Clinical Reminder Screen
552094|NCT00852527|P1|Participant Flow|Positive Mild TBI|Participants who screened positive on the TBI Clinical Reminder Screen
552099|NCT00852540|B2|Baseline|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552100|NCT00852540|B1|Baseline|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552101|NCT00852540|P2|Participant Flow|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552102|NCT00852540|P1|Participant Flow|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552103|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (&gt;=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were &lt;5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552104|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552105|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (&gt;=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were &lt;5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552106|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552107|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552108|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552109|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552110|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552111|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552112|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552113|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552114|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552115|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552116|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552117|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552118|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552119|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552145|NCT00852761|B2|Baseline|Clobex Lotion|Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
552146|NCT00852761|B1|Baseline|Olux-E Foam|Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
552147|NCT00852761|P2|Participant Flow|Clobex Lotion|Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
552120|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552121|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552122|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552123|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552124|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552125|NCT00852540|E2|Reported Event|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
552126|NCT00852540|E1|Reported Event|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
552127|NCT00852592|B3|Baseline|Total|Total of all reporting groups
552128|NCT00852592|B2|Baseline|Inactive Comparator|"inactive light unit
Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily"
552129|NCT00852592|B1|Baseline|Active Comparator|"active light unit
active light therapy unit: dosage - 15-60minutes NOON-2PM daily"
552130|NCT00852592|P2|Participant Flow|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
552131|NCT00852592|P1|Participant Flow|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
552132|NCT00852592|O2|Outcome|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
552133|NCT00852592|O1|Outcome|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
552134|NCT00852592|O2|Outcome|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
552135|NCT00852592|O1|Outcome|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
552136|NCT00852592|E2|Reported Event|Inactive Comparator|inactive light unit Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
552137|NCT00852592|E1|Reported Event|Active Comparator|"active light unit
active light therapy unit: dosage - 15-60minutes NOON-2PM daily"
552138|NCT00852631|B1|Baseline|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
552139|NCT00852631|P1|Participant Flow|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
552140|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
552141|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
552142|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
552143|NCT00852631|E1|Reported Event|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
552144|NCT00852761|B3|Baseline|Total|Total of all reporting groups
552148|NCT00852761|P1|Participant Flow|Olux-E Foam|Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
552149|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552150|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552151|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552152|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552153|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552154|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552155|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552156|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552157|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552158|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552159|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552160|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552161|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552162|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552163|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552164|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552165|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552166|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552167|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552168|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552169|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552170|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552171|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552172|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552173|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552174|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552175|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552176|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552177|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552178|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552179|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552180|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552181|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552182|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552183|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552184|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552185|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552186|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552187|NCT00852761|E2|Reported Event|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
552188|NCT00852761|E1|Reported Event|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
552189|NCT00852917|B5|Baseline|Total|Total of all reporting groups
552190|NCT00852917|B4|Baseline|4: Placebo|
552191|NCT00852917|B3|Baseline|3: Tramadol Once A Day 300mg|
552192|NCT00852917|B2|Baseline|2: Tramadol Once A Day 200mg|
552193|NCT00852917|B1|Baseline|1: Tramadol Once A Day 100mg|
552194|NCT00852917|P4|Participant Flow|4: Placebo|
552195|NCT00852917|P3|Participant Flow|3: Tramadol Once A Day 300mg|
552196|NCT00852917|P2|Participant Flow|2: Tramadol Once A Day 200mg|
552197|NCT00852917|P1|Participant Flow|1: Tramadol Once A Day 100mg|
552198|NCT00852917|O4|Outcome|4: Placebo|
552199|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
552200|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
552201|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
552202|NCT00852917|O4|Outcome|4: Placebo|
552203|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
552204|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
552205|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
552206|NCT00852917|O4|Outcome|4: Placebo|
552207|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
552208|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
552209|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
552210|NCT00852917|O4|Outcome|4: Placebo|
552211|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
552212|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
552213|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
552214|NCT00852917|O4|Outcome|4: Placebo|
552215|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
552216|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
552217|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
552218|NCT00852917|O4|Outcome|4: Placebo|
552219|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
552220|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
552221|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
552222|NCT00852917|O4|Outcome|4: Placebo|
552223|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
552224|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
552225|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
552235|NCT00852930|B3|Baseline|Laser and Mld Combined|"therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
552236|NCT00852930|B2|Baseline|Mld Alone|"therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy"
552237|NCT00852930|B1|Baseline|Laser Therapy Alone|"therapist administered laser treatment
laser: therapist administered laser"
552238|NCT00852930|P3|Participant Flow|Laser and Mld Combined|"therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
552239|NCT00852930|P2|Participant Flow|Mld Alone|"therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy"
552240|NCT00852930|P1|Participant Flow|Laser Therapy Alone|"therapist administered laser treatment
laser: therapist administered laser"
552241|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
552242|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage (mld)
manual lymphatic drainage: therapist administered massage therapy"
552243|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment
laser: therapist administered laser"
552244|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
552245|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy"
552246|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment
laser: therapist administered laser"
552247|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
552248|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy"
552249|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment
laser: therapist administered laser"
552250|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
552251|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy"
552252|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment
laser: therapist administered laser"
552253|NCT00852930|E3|Reported Event|Laser and Mld Combined|"therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment
No adverse events during the study."
552254|NCT00852930|E2|Reported Event|Mld Alone|"therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy
No adverse events during the study."
552255|NCT00852930|E1|Reported Event|Laser Therapy Alone|"therapist administered laser treatment
laser: therapist administered laser
No adverse events during the study."
552256|NCT00852969|B3|Baseline|Total|Total of all reporting groups
552257|NCT00852969|B2|Baseline|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
552258|NCT00852969|B1|Baseline|Niacin|Niacin : 1000 mg tablets once per day
552259|NCT00852969|P2|Participant Flow|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
552260|NCT00852969|P1|Participant Flow|Niacin|Niacin : 1000 mg tablets once per day
552261|NCT00852969|O2|Outcome|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
552262|NCT00852969|O1|Outcome|Niacin|Niacin : 1000 mg tablets once per day
552263|NCT00852969|O2|Outcome|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
552264|NCT00852969|O1|Outcome|Niacin|Niacin : 1000 mg tablets once per day
552265|NCT00852969|E2|Reported Event|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
552266|NCT00852969|E1|Reported Event|Niacin|Niacin : 1000 mg tablets once per day
552267|NCT00852995|B6|Baseline|Total|Total of all reporting groups
552268|NCT00852995|B5|Baseline|C - High Q7D|"High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552269|NCT00852995|B4|Baseline|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552270|NCT00852995|B3|Baseline|A - Low Q7D|"Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552271|NCT00852995|B2|Baseline|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552272|NCT00852995|B1|Baseline|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
552273|NCT00852995|P5|Participant Flow|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
552274|NCT00852995|P4|Participant Flow|C - High Q7D|"High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552300|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552275|NCT00852995|P3|Participant Flow|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552276|NCT00852995|P2|Participant Flow|A - Low Q7D|"Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552277|NCT00852995|P1|Participant Flow|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552278|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552279|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552280|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552281|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552282|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
552283|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552284|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552285|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552286|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552287|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
552288|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552289|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552290|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552291|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552292|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
552293|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552294|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552295|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552296|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552297|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
552298|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552299|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
560084|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
552301|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552302|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
552303|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552304|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552305|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552306|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552307|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
552308|NCT00852995|O5|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
552309|NCT00852995|O4|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552310|NCT00852995|O3|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552311|NCT00852995|O2|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552312|NCT00852995|O1|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552313|NCT00852995|E5|Reported Event|C - High Q7D|"High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552314|NCT00852995|E4|Reported Event|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552315|NCT00852995|E3|Reported Event|A - Low Q7D|"Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552316|NCT00852995|E2|Reported Event|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
552317|NCT00852995|E1|Reported Event|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
552318|NCT00853021|B1|Baseline|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
552319|NCT00853021|P1|Participant Flow|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
552320|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
552321|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
552322|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
552323|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
552324|NCT00853021|E1|Reported Event|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
552325|NCT00853073|B3|Baseline|Total|Total of all reporting groups
552449|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552326|NCT00853073|B2|Baseline|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
552327|NCT00853073|B1|Baseline|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
552328|NCT00853073|P2|Participant Flow|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
552329|NCT00853073|P1|Participant Flow|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
552330|NCT00853073|O2|Outcome|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
552331|NCT00853073|O1|Outcome|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
552332|NCT00853073|E2|Reported Event|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
552333|NCT00853073|E1|Reported Event|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
552334|NCT00853099|B4|Baseline|Total|Total of all reporting groups
552335|NCT00853099|B3|Baseline|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552336|NCT00853099|B2|Baseline|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552337|NCT00853099|B1|Baseline|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552338|NCT00853099|P4|Participant Flow|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
552339|NCT00853099|P3|Participant Flow|Double-blind Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
552340|NCT00853099|P2|Participant Flow|Double-blind Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
552341|NCT00853099|P1|Participant Flow|Double-blind Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.
552342|NCT00853099|O1|Outcome|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
552343|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552344|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552405|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552345|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552346|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552347|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552348|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552349|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552350|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552351|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552352|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552353|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552354|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552355|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552356|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552357|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552358|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552406|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552580|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552359|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552360|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552361|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552362|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552363|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552364|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552365|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552366|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552367|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552368|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552369|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552370|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552371|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552372|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552407|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552408|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552373|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552374|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552375|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
552376|NCT00853099|E4|Reported Event|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
552377|NCT00853099|E3|Reported Event|Double-blind Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
552378|NCT00853099|E2|Reported Event|Double-blind Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
552379|NCT00853099|E1|Reported Event|Double-blind Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.
552380|NCT00853151|B5|Baseline|Total|Total of all reporting groups
552381|NCT00853151|B4|Baseline|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552382|NCT00853151|B3|Baseline|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552383|NCT00853151|B2|Baseline|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552384|NCT00853151|B1|Baseline|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552385|NCT00853151|P4|Participant Flow|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552386|NCT00853151|P3|Participant Flow|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552387|NCT00853151|P2|Participant Flow|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552388|NCT00853151|P1|Participant Flow|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552389|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552390|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552391|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552392|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552393|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552394|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552395|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552396|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552397|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552398|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552399|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552400|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552401|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552402|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552403|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552404|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552409|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552410|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552411|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552412|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552413|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552414|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552415|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552416|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552417|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552418|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552419|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552420|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552421|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552422|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552423|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552424|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552425|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552426|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552427|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552428|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552429|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552430|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552431|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552432|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552433|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552434|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552435|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552436|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552437|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552438|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552439|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552440|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552441|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552442|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552443|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks TT223
552444|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552445|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552446|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552447|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552448|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
560085|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
552450|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552451|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552452|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552453|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552454|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552455|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks TT223
552456|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552457|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552458|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552459|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552460|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552461|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552462|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552463|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552464|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552465|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552466|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552467|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552468|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552469|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552470|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552471|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552472|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552473|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552474|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552475|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552476|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552477|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552478|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552479|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552480|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552481|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552482|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552483|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552484|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552485|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552486|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552487|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552488|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552489|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552960|NCT00860262|B1|Baseline|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552490|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552491|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552492|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552493|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552494|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552495|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552496|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552497|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552498|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552499|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552500|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552501|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552502|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552503|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552504|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552505|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552506|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552507|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552508|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552509|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552510|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552511|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552512|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552513|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552514|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552515|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552516|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552517|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552518|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552519|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552520|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552521|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552522|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552523|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552524|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552525|NCT00853151|E4|Reported Event|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552526|NCT00853151|E3|Reported Event|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
552527|NCT00853151|E2|Reported Event|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
552528|NCT00853151|E1|Reported Event|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
552529|NCT00853229|B3|Baseline|Total|Total of all reporting groups
552581|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552530|NCT00853229|B2|Baseline|Placebo First 4 Weeks|"placebo and pregabalin given using a cross-over design
pregabalin: pregabalin 150mg twice daily for 4 weeks"
552531|NCT00853229|B1|Baseline|Pregabalin First 4 Weeks|"pregabalin and placebo given using a cross-over design
pregabalin: pregabalin 150mg twice daily for 4 weeks"
552532|NCT00853229|P2|Participant Flow|Placebo First 4 Weeks|"placebo and pregabalin given using a cross-over design
pregabalin: pregabalin 150mg twice daily for 4 weeks"
552533|NCT00853229|P1|Participant Flow|Pregabalin First 4 Weeks|"pregabalin and placebo given using a cross-over design
pregabalin: pregabalin 150mg twice daily for 4 weeks"
552534|NCT00853229|O2|Outcome|Placebo/Pregabalin|"placebo and pregabalin given using a cross-over design
pregabalin: pregabalin 150mg twice daily for 4 weeks"
552535|NCT00853229|O1|Outcome|Pregabalin/Placebo|"pregabalin and placebo given using a cross-over design
pregabalin: pregabalin 150mg twice daily for 4 weeks"
552536|NCT00853229|E2|Reported Event|Placebo/Pregabalin|"placebo and pregabalin given using a cross-over design
pregabalin: pregabalin 150mg twice daily for 4 weeks"
552537|NCT00853229|E1|Reported Event|Pregabalin/Placebo|"pregabalin and placebo given using a cross-over design
pregabalin: pregabalin 150mg twice daily for 4 weeks"
552538|NCT00853242|B8|Baseline|Total|Total of all reporting groups
552539|NCT00853242|B7|Baseline|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552540|NCT00853242|B6|Baseline|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552541|NCT00853242|B5|Baseline|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552542|NCT00853242|B4|Baseline|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552543|NCT00853242|B3|Baseline|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552544|NCT00853242|B2|Baseline|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552545|NCT00853242|B1|Baseline|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
552546|NCT00853242|P7|Participant Flow|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552547|NCT00853242|P6|Participant Flow|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552548|NCT00853242|P5|Participant Flow|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552549|NCT00853242|P4|Participant Flow|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552550|NCT00853242|P3|Participant Flow|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552551|NCT00853242|P2|Participant Flow|Genz-644470 2.4 Grams Per Day (g/Day)|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552552|NCT00853242|P1|Participant Flow|Placebo|Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
552553|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552554|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552555|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552556|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552557|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552558|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552559|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
552560|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552561|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552562|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552563|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552564|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552565|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552566|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
552567|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552568|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552569|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552570|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552571|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552572|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552573|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
552574|NCT00853242|O6|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552575|NCT00853242|O5|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552576|NCT00853242|O4|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552577|NCT00853242|O3|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552578|NCT00853242|O2|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552579|NCT00853242|O1|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552582|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552583|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
552584|NCT00853242|E7|Reported Event|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552585|NCT00853242|E6|Reported Event|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552586|NCT00853242|E5|Reported Event|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552587|NCT00853242|E4|Reported Event|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
552588|NCT00853242|E3|Reported Event|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
552589|NCT00853242|E2|Reported Event|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
552590|NCT00853242|E1|Reported Event|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
552591|NCT00858689|B1|Baseline|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
552592|NCT00858689|P1|Participant Flow|Minocyline 50 mg or 100 mg PO BID|open label, single arm study of minocyline 50 mg or 100 mg PO BID
552593|NCT00858689|O1|Outcome|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
552594|NCT00858689|O1|Outcome|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
552595|NCT00858689|E1|Reported Event|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
552596|NCT00858702|B3|Baseline|Total|Total of all reporting groups
552597|NCT00858702|B2|Baseline|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic once daily for 8 weeks
552598|NCT00858702|B1|Baseline|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks
552599|NCT00858702|P2|Participant Flow|Olmesartan Medoxomil Tablets and a Diuretic Tablet|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class)once daily for 8 weeks
552600|NCT00858702|P1|Participant Flow|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
552601|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet(of the the thiazide class) once daily for 8 weeks
552602|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
552603|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
552604|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker (of the dihydropyridine class) tablet, once daily for 8 weeks
552605|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
552606|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
552607|NCT00858702|E2|Reported Event|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic once daily for 8 weeks
552608|NCT00858702|E1|Reported Event|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks
552609|NCT00858780|B1|Baseline|Entire Study Population|Includes all participants who were enrolled in this study.
552610|NCT00858780|P5|Participant Flow|Etanercept 50 mg – Period 3|Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
552611|NCT00858780|P4|Participant Flow|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552612|NCT00858780|P3|Participant Flow|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552613|NCT00858780|P2|Participant Flow|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552614|NCT00858780|P1|Participant Flow|Etanercept 50 mg – Period 1|Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.
552734|NCT00859508|O2|Outcome|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
552615|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552616|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552617|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552618|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552619|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552620|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552621|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552622|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552623|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552624|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552625|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552626|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552627|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552628|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552629|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552630|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552631|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552632|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552633|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552634|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552635|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552636|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552637|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552638|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552639|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552640|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552641|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552642|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552643|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552644|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552645|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552646|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552647|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552648|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552649|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552650|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552651|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552652|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552653|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552654|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552655|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552656|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552657|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552658|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552659|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552660|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552661|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552662|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552663|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552664|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552665|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552666|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552667|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552668|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552669|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552670|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552671|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552672|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552673|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552674|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552675|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552676|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552677|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552678|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552679|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552680|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552681|NCT00858780|E5|Reported Event|Etanercept 50 mg – Period 3|Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
552682|NCT00858780|E4|Reported Event|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552683|NCT00858780|E3|Reported Event|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
552684|NCT00858780|E2|Reported Event|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
552685|NCT00858780|E1|Reported Event|Etanercept 50 mg – Period 1|Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.
552686|NCT00858832|B3|Baseline|Total|Total of all reporting groups
552687|NCT00858832|B2|Baseline|No Methergine|
552688|NCT00858832|B1|Baseline|Methergine|
552689|NCT00858832|P2|Participant Flow|No Treatment|Participants received no intervention (no treatment).
552690|NCT00858832|P1|Participant Flow|Methergine|Participants received Methergine 0.2mg orally every 6 hours for 2 days
552691|NCT00858832|O2|Outcome|No Methergine|
552692|NCT00858832|O1|Outcome|Methergine|
552693|NCT00858832|E2|Reported Event|No Methergine|
552694|NCT00858832|E1|Reported Event|Methergine|
552695|NCT00858845|B1|Baseline|Clonidine Patch|Participants will wear a clonidine patch.
552696|NCT00858845|P1|Participant Flow|Clonidine Patch|Participants will wear a clonidine patch.
552697|NCT00858845|O1|Outcome|Clonidine Patch|Participants will wear a clonidine patch.
552698|NCT00858845|E1|Reported Event|Clonidine Patch|Participants will wear a clonidine patch.
552699|NCT00858858|B1|Baseline|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
552700|NCT00858858|P1|Participant Flow|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
552701|NCT00858858|O1|Outcome|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
552735|NCT00859508|O1|Outcome|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
552736|NCT00859508|E2|Reported Event|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
552737|NCT00859508|E1|Reported Event|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
552702|NCT00858858|E1|Reported Event|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
552703|NCT00858962|B1|Baseline|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
552704|NCT00858962|P1|Participant Flow|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
552705|NCT00858962|O1|Outcome|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
552706|NCT00858962|E1|Reported Event|Bup/Ral|HIV negative subjects currently enrolled in Buprenorphine maintenance therapy on a stable dose of BUP for at least 3 weeks were admitted to the HRU for PK sampling at intervals over a 24 hour period. Subjects then received RAL and BUP co-administration for a minimum of 4 days after which a second series of blood draws at intervals over a 24 hour period were conducted.
552707|NCT00859014|B1|Baseline|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
552708|NCT00859014|P1|Participant Flow|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
552709|NCT00859014|O1|Outcome|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
552710|NCT00859014|O1|Outcome|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
552711|NCT00859014|E1|Reported Event|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
552712|NCT00859430|B3|Baseline|Total|Total of all reporting groups
552713|NCT00859430|B2|Baseline|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
552714|NCT00859430|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
552715|NCT00859430|P2|Participant Flow|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
552716|NCT00859430|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
552717|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
552718|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
552719|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
552720|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
552721|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
552722|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
552723|NCT00859469|B1|Baseline|Oxaliplatin and Gemcitabine|
552724|NCT00859469|P1|Participant Flow|Oxaliplatin and Gemcitabine|
552725|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
552726|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
552727|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
552728|NCT00859469|E1|Reported Event|Oxaliplatin and Gemcitabine|
552729|NCT00859508|B3|Baseline|Total|Total of all reporting groups
552730|NCT00859508|B2|Baseline|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
552731|NCT00859508|B1|Baseline|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
552732|NCT00859508|P2|Participant Flow|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
552733|NCT00859508|P1|Participant Flow|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
552738|NCT00859521|B3|Baseline|Total|Total of all reporting groups
552961|NCT00860262|P3|Participant Flow|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552739|NCT00859521|B2|Baseline|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
552740|NCT00859521|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
552741|NCT00859521|P2|Participant Flow|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
552742|NCT00859521|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
552743|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
552744|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
552745|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
552746|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
552747|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
552748|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
552749|NCT00859547|B1|Baseline|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
552750|NCT00859547|P1|Participant Flow|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
552751|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
552752|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
552753|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
552754|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
552755|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
552756|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
552757|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
552758|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
552759|NCT00859547|E1|Reported Event|TOTAL|
552760|NCT00859573|B3|Baseline|Total|Total of all reporting groups
552761|NCT00859573|B2|Baseline|Placebo|Two placebo tablets orally once daily
552762|NCT00859573|B1|Baseline|Modafinil|Modafinil 400mg orally once daily
552763|NCT00859573|P2|Participant Flow|Placebo|Two placebo tablets orally once daily
552764|NCT00859573|P1|Participant Flow|Modafinil|Modafinil 400mg orally once daily
552765|NCT00859573|O2|Outcome|Modafinil|Modafinil 400mg orally daily
552766|NCT00859573|O1|Outcome|Placebo|Participants received 2 capsules placebo orally daily
552767|NCT00859573|E2|Reported Event|Placebo|Two placebo tablets orally once daily
552768|NCT00859573|E1|Reported Event|Modafinil|Modafinil 400mg orally once daily
552769|NCT00859586|B1|Baseline|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.
This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
552770|NCT00859586|P1|Participant Flow|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.
This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
552771|NCT00859586|O1|Outcome|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.
This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
552772|NCT00859586|E1|Reported Event|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.
This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
552773|NCT00859638|B3|Baseline|Total|Total of all reporting groups
552775|NCT00859638|B1|Baseline|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
552776|NCT00859638|P2|Participant Flow|Case Matched Controls|Usual care in primary health care.
552777|NCT00859638|P1|Participant Flow|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
552778|NCT00859638|O2|Outcome|Case Matched Controls|Usual care in primary health care.
552779|NCT00859638|O1|Outcome|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
552780|NCT00859638|E2|Reported Event|Case Matched Controls|Usual care in primary health care.
552781|NCT00859638|E1|Reported Event|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
552782|NCT00859833|B1|Baseline|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
552783|NCT00859833|P1|Participant Flow|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson was given (0.4 mg) given as in i.v. bolus.
552784|NCT00859833|O2|Outcome|Regadenoson|Regadenoson 0.5 mg i.v. bolus.
552785|NCT00859833|O1|Outcome|Adenosine|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes).
552786|NCT00859833|E1|Reported Event|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
552787|NCT00859898|B4|Baseline|Total|Total of all reporting groups
552788|NCT00859898|B3|Baseline|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552789|NCT00859898|B2|Baseline|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
552790|NCT00859898|B1|Baseline|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552791|NCT00859898|P3|Participant Flow|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552792|NCT00859898|P2|Participant Flow|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks.
Placebo: Metformin hydrochloride (HCl) Modified Release matching placebo tablets, once daily, 24 weeks."
552793|NCT00859898|P1|Participant Flow|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552794|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552795|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
552796|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552797|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552798|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
552799|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552800|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552801|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
552802|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552803|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552804|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
552805|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552806|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552807|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
552808|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552809|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552810|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
552811|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552812|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552813|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
552962|NCT00860262|P2|Participant Flow|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552814|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552815|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552816|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
552817|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552818|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552819|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
552820|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552821|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552822|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
552823|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552824|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552825|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
552826|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552827|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552828|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
552829|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552830|NCT00859898|E3|Reported Event|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
552831|NCT00859898|E2|Reported Event|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
552832|NCT00859898|E1|Reported Event|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
552833|NCT00859937|B3|Baseline|Total|Total of all reporting groups
552834|NCT00859937|B2|Baseline|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552835|NCT00859937|B1|Baseline|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552836|NCT00859937|P2|Participant Flow|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552837|NCT00859937|P1|Participant Flow|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552838|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552839|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552840|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552841|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552842|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552843|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552844|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552845|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552970|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552846|NCT00859937|E2|Reported Event|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552847|NCT00859937|E1|Reported Event|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
552848|NCT00859950|B3|Baseline|Total|Total of all reporting groups
552849|NCT00859950|B2|Baseline|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
552850|NCT00859950|B1|Baseline|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.
Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
552851|NCT00859950|P2|Participant Flow|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
552852|NCT00859950|P1|Participant Flow|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.
Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
552853|NCT00859950|O2|Outcome|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
552854|NCT00859950|O1|Outcome|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.
Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
552855|NCT00859950|E2|Reported Event|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.
Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw.
Serious and Other [Not Including Serious] Adverse Events were not observed."
552856|NCT00859950|E1|Reported Event|Normal Control|"Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
Serious and Other [Not Including Serious] Adverse Events were not observed."
552857|NCT00860028|B3|Baseline|Total|Total of all reporting groups
552858|NCT00860028|B2|Baseline|Short Varenicline Pretreatment (Placebo)|Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
552859|NCT00860028|B1|Baseline|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
552860|NCT00860028|P2|Participant Flow|Placebo Pretreatment/Varenicline Treatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
552861|NCT00860028|P1|Participant Flow|Varenicline Pretreatment/Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.
552862|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date
552863|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date
552864|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
552865|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date.
552866|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
552867|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date
552868|NCT00860028|E2|Reported Event|Short Varenicline Pretreatment (Placebo)|Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
552869|NCT00860028|E1|Reported Event|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
552870|NCT00860067|B4|Baseline|Total|Total of all reporting groups
552871|NCT00860067|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
552872|NCT00860067|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
552873|NCT00860067|B1|Baseline|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552874|NCT00860067|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
552875|NCT00860067|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
552876|NCT00860067|P1|Participant Flow|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552877|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552878|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552879|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552880|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552881|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552882|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552883|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552884|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552885|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552886|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552963|NCT00860262|P1|Participant Flow|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552964|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552965|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552887|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
552888|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552889|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
552890|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552891|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552892|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552893|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552894|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552895|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
552896|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552897|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
552898|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552899|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552900|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552901|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552902|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552903|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552904|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
552905|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
552906|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552907|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
552908|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552909|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
552910|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552911|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552912|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552913|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552914|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552915|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
552916|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552917|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
552918|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552919|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552920|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552921|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552922|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552923|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552924|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
552925|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
552926|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552927|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552928|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
552929|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
552930|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552931|NCT00860067|E2|Reported Event|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
552932|NCT00860067|E1|Reported Event|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
552933|NCT00860158|B1|Baseline|Experimental Arm|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
552934|NCT00860158|P1|Participant Flow|Experimental Arm|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
552935|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
552966|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552967|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552968|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552969|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552936|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
552937|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
552938|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
552939|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
552940|NCT00860158|E1|Reported Event|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
552941|NCT00860249|B4|Baseline|Total|Total of all reporting groups
552942|NCT00860249|B3|Baseline|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
552943|NCT00860249|B2|Baseline|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
552944|NCT00860249|B1|Baseline|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
552945|NCT00860249|P3|Participant Flow|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
552946|NCT00860249|P2|Participant Flow|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
552947|NCT00860249|P1|Participant Flow|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
552948|NCT00860249|O3|Outcome|Behavioral: Letter and Educational DVD|Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
552949|NCT00860249|O2|Outcome|Behavioral: Letter Only|Participants in this arm will receive a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
552950|NCT00860249|O1|Outcome|Usual Care|Usual Care - participants receive usual care
552951|NCT00860249|O3|Outcome|Behavioral: Letter and Educational DVD|Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
552952|NCT00860249|O2|Outcome|Behavioral: Letter Only|Participants in this arm will receive a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
552953|NCT00860249|O1|Outcome|Usual Care|Usual Care - participants receive usual care
552954|NCT00860249|E3|Reported Event|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
552955|NCT00860249|E2|Reported Event|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
552956|NCT00860249|E1|Reported Event|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
552957|NCT00860262|B4|Baseline|Total|Total of all reporting groups
552958|NCT00860262|B3|Baseline|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552959|NCT00860262|B2|Baseline|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
560086|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
552971|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552972|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552973|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552974|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552975|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552976|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552977|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552978|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552979|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552980|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552981|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552982|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552983|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552984|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552985|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552986|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552987|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552988|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552989|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552990|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552991|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552992|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552993|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552994|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552995|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552996|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
552997|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
552998|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
552999|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
553000|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
553001|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553002|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
553003|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
553004|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553005|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
553006|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
553007|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553008|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
553009|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553010|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553011|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553012|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553013|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553014|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553015|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553016|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553017|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553018|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553019|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553020|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553021|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553022|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553023|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553024|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553025|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553026|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553027|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553028|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553029|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553030|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553031|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553032|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553033|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553034|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553035|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553036|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553037|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553038|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553039|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553040|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553041|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553042|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553043|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553044|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553045|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
553046|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553047|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
553048|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
553049|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553050|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
553051|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
553052|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553053|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
553054|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553055|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553056|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553057|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
553058|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553059|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
553060|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
553061|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553062|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
553063|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
553064|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553065|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
553066|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
553067|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553068|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
553069|NCT00860262|E3|Reported Event|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
553070|NCT00860262|E2|Reported Event|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
553071|NCT00860262|E1|Reported Event|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
553072|NCT00860314|B3|Baseline|Total|Total of all reporting groups
553073|NCT00860314|B2|Baseline|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
553074|NCT00860314|B1|Baseline|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
553075|NCT00860314|P2|Participant Flow|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
553076|NCT00860314|P1|Participant Flow|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
553077|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
553078|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
553079|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
553080|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
553081|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
553082|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
553083|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
553084|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
553085|NCT00860314|E2|Reported Event|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
553086|NCT00860314|E1|Reported Event|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
553087|NCT00860405|B3|Baseline|Total|Total of all reporting groups
553088|NCT00860405|B2|Baseline|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553089|NCT00860405|B1|Baseline|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553090|NCT00860405|P2|Participant Flow|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553091|NCT00860405|P1|Participant Flow|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553092|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553093|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553094|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553095|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553096|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553097|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553098|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553099|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553100|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553101|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553102|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553103|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553104|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553105|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553106|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553107|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553108|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553109|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553110|NCT00860405|E2|Reported Event|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
553111|NCT00860405|E1|Reported Event|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
553112|NCT00860457|B1|Baseline|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide
Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles
Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles
Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
553113|NCT00860457|P1|Participant Flow|Chemotherapy|Fludarabine/Rituximab followed by Lenalidomide
553114|NCT00860457|O1|Outcome|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide
Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles
Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles
Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
553115|NCT00860457|E1|Reported Event|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide
Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles
Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles
Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
553116|NCT00860470|B3|Baseline|Total|Total of all reporting groups
553117|NCT00860470|B2|Baseline|Multiple Micronutrient|"Multiple micronutrient
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553118|NCT00860470|B1|Baseline|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553119|NCT00860470|P2|Participant Flow|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553120|NCT00860470|P1|Participant Flow|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553121|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553122|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553123|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553124|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553125|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553126|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553127|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553128|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553129|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553130|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553131|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553132|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553133|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553134|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553135|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553136|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553137|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553138|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553139|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553140|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553141|NCT00860470|E2|Reported Event|Multiple Micronutrient|"Multiple micronutrient
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553142|NCT00860470|E1|Reported Event|Iron (27 mg) and Folic Acid (600 ug)|"Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
553143|NCT00860535|B1|Baseline|Ph+ CML or Ph+ ALL|Growth Factor Signature (GFS) biomarker evaluation in participants with blast phase Ph+ CML or Ph+ ALL who were treated with imatinib, dasatinib or nilotinib as per standard of care.
553144|NCT00860535|P1|Participant Flow|Ph+ CML or Ph+ ALL|Participants with blast phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL) who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
553145|NCT00860535|O1|Outcome|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
553146|NCT00860535|O1|Outcome|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
553170|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
553147|NCT00860535|E1|Reported Event|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care.
553148|NCT00860743|B7|Baseline|Total|Total of all reporting groups
553149|NCT00860743|B6|Baseline|Aim 2 - Healthy - Hypoxia - Antioxidant/Placebo|We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
553150|NCT00860743|B5|Baseline|Aim 2 - OSA - Hypoxia - Antioxidant/Placebo|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
553151|NCT00860743|B4|Baseline|Aim 1 - Healthy Females- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
553152|NCT00860743|B3|Baseline|Aim 1 - Healthy Males- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 healthy males. These males will be matched with 10 OSA males and 10 OSA females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
553153|NCT00860743|B2|Baseline|Aim 1 - OSA Female- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 OSA females. These females will be matched with 10 males with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
553154|NCT00860743|B1|Baseline|Aim 1 - OSA Male - Sleep/Wake - Hypoxia/Sham|"We plan to study 10 OSA males. These males will be matched with 10 females with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
553155|NCT00860743|P2|Participant Flow|Arm 2|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
553156|NCT00860743|P1|Participant Flow|OSA/Healthy - Males/Females - Wake/Sleep|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
553157|NCT00860743|O1|Outcome|OSA/HEALTHY - HYPOXIA - ANTIOXIDANT/PLACEBO|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
553158|NCT00860743|O1|Outcome|OSA/HEALTHY - MALES/FEMALES - WAKE/SLEEP|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
553159|NCT00860743|E2|Reported Event|Arm 2|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
553160|NCT00860743|E1|Reported Event|Arm 1|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
553161|NCT00860795|B3|Baseline|Total|Total of all reporting groups
553162|NCT00860795|B2|Baseline|Placebo|25 ml daily in 2 divided doses for 10 days
553163|NCT00860795|B1|Baseline|Echinacea|25 ml daily in 2 divided doses for 10 days
553164|NCT00860795|P2|Participant Flow|Placebo|25 ml daily in 2 divided doses for 10 days
553165|NCT00860795|P1|Participant Flow|Echinacea|25 ml daily in 2 divided doses for 10 days
553166|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
553167|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
553168|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
553169|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
560087|NCT00882687|O4|Outcome|Placebo|
553171|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
553172|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
553173|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
553174|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
553175|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
553176|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
553177|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
553178|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
553179|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
553180|NCT00860795|E2|Reported Event|Placebo|25 ml daily in 2 divided doses for 10 days
553181|NCT00860795|E1|Reported Event|Echinacea|25 ml daily in 2 divided doses for 10 days
553182|NCT00860847|B3|Baseline|Total|Total of all reporting groups
553183|NCT00860847|B2|Baseline|Placebo|Patients randomized to placebo
553184|NCT00860847|B1|Baseline|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
553185|NCT00860847|P2|Participant Flow|Placebo|Patients randomized to placebo
553186|NCT00860847|P1|Participant Flow|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
553187|NCT00860847|O2|Outcome|Placebo|Patients randomized to placebo
553188|NCT00860847|O1|Outcome|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
553189|NCT00860847|E2|Reported Event|Placebo|Patients randomized to placebo
553190|NCT00860847|E1|Reported Event|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
553191|NCT00860951|B1|Baseline|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?
Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
553192|NCT00860951|P1|Participant Flow|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?
Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
553193|NCT00860951|O3|Outcome|Assistive Technology Enironment|Average accuracy of selections for three sessions of text copying with the BCI acting as a keyboard replacement for a communication system.
553194|NCT00860951|O2|Outcome|Computer Environment|Average accuracy of selections for three sessions of text copying within the BCI acting as a keyboard replacement for a laptop computer.
553195|NCT00860951|O1|Outcome|BCI Environment|Average accuracy of selections for three sessions of text copying within the BCI as a stand-alone device.
553196|NCT00860951|E1|Reported Event|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?
Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
553197|NCT00861146|B3|Baseline|Total|Total of all reporting groups
553198|NCT00861146|B2|Baseline|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553199|NCT00861146|B1|Baseline|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553200|NCT00861146|P2|Participant Flow|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553201|NCT00861146|P1|Participant Flow|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553202|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553203|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553204|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553205|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553206|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553207|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553208|NCT00861146|E2|Reported Event|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553209|NCT00861146|E1|Reported Event|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
553210|NCT00861198|B1|Baseline|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
553211|NCT00861198|P1|Participant Flow|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
553212|NCT00861198|O1|Outcome|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
553213|NCT00861198|E1|Reported Event|ERCP|"Patients who have a medical indication for ERCP with cholangioscopy and/or pancreatoscopy and are referred for the procedure as part of their standard medical care will be considered for the study.
ERCP as per medical indication: ERCP as per medical indication"
553214|NCT00861263|B1|Baseline|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
553215|NCT00861263|P1|Participant Flow|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
553216|NCT00861263|O1|Outcome|Spiral Enteroscopy Subjects|All subjects followed up after spiral enteroscopy
553217|NCT00861263|E1|Reported Event|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
553218|NCT00861341|B1|Baseline|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
553219|NCT00861341|P1|Participant Flow|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
553220|NCT00861341|O1|Outcome|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
553221|NCT00861341|O1|Outcome|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
553222|NCT00861341|E1|Reported Event|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
553223|NCT00861471|B1|Baseline|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
553224|NCT00861471|P1|Participant Flow|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
553225|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
553226|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
553227|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
553228|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
553229|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
553230|NCT00861471|E1|Reported Event|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
553231|NCT00861601|B4|Baseline|Total|Total of all reporting groups
553232|NCT00861601|B3|Baseline|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553233|NCT00861601|B2|Baseline|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553234|NCT00861601|B1|Baseline|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553235|NCT00861601|P3|Participant Flow|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553236|NCT00861601|P2|Participant Flow|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553237|NCT00861601|P1|Participant Flow|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553238|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553239|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553240|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553241|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553242|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553243|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553244|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553245|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553246|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553247|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553248|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553249|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553250|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553251|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553252|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553253|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553254|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553255|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553256|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553257|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553258|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553259|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553260|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553261|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553262|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
560088|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
553263|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553264|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553265|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553266|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553267|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553268|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553269|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553270|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553271|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553272|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553273|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553274|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553275|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553276|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 mg of eltrombopag once daily for 14 days.
553277|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553278|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553279|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 mg of eltrombopag once daily for 14 days.
553280|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553281|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553282|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553283|NCT00861601|E3|Reported Event|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553284|NCT00861601|E2|Reported Event|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
553285|NCT00861601|E1|Reported Event|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
553286|NCT00861614|B3|Baseline|Total|Total of all reporting groups
553287|NCT00861614|B2|Baseline|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed PD, drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553288|NCT00861614|B1|Baseline|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4,7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553552|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553553|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553554|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553289|NCT00861614|P2|Participant Flow|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553290|NCT00861614|P1|Participant Flow|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gray units (Gy) to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553291|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553292|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553293|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553294|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553295|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553296|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553297|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553298|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553299|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553300|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
560089|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
553301|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553302|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553303|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553304|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553305|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553306|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553307|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553308|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553309|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553310|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553311|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553312|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553555|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553313|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553314|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553315|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553316|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553317|NCT00861614|E2|Reported Event|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553318|NCT00861614|E1|Reported Event|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
553319|NCT00861692|B1|Baseline|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
553320|NCT00861692|P1|Participant Flow|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
553321|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
553322|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
553323|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
553324|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
553325|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
553326|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
553327|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
553328|NCT00861692|E1|Reported Event|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
553329|NCT00861705|B5|Baseline|Total|Total of all reporting groups
553330|NCT00861705|B4|Baseline|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV
carboplatin: Given IV"
553331|NCT00861705|B3|Baseline|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
carboplatin: Given IV"
553332|NCT00861705|B2|Baseline|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV"
553333|NCT00861705|B1|Baseline|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV"
553334|NCT00861705|P4|Participant Flow|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV
carboplatin: Given IV"
553335|NCT00861705|P3|Participant Flow|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
carboplatin: Given IV"
553336|NCT00861705|P2|Participant Flow|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV"
553337|NCT00861705|P1|Participant Flow|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV"
553338|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
553339|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
553340|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
553341|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
553342|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
553343|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
553344|NCT00861705|O2|Outcome|Factor A: No Carboplatin|Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 & 2).
553345|NCT00861705|O1|Outcome|Factor A: Carboplatin|Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 & 4).
553346|NCT00861705|O2|Outcome|Factor A: No Carboplatin|Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 & 2).
553347|NCT00861705|O1|Outcome|Factor A: Carboplatin|Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 & 4).
553348|NCT00861705|E4|Reported Event|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|carboplatin: Given IV
553349|NCT00861705|E3|Reported Event|Arm 3 (Pac + Carboplatin --> ddAC)|carboplatin: Given IV
553350|NCT00861705|E2|Reported Event|Arm 2 (Pac + Bev --> ddAC + Bev)|bevacizumab: Given IV
553351|NCT00861705|E1|Reported Event|Arm 1 (Pac --> ddAC)|cyclophosphamide: Given IV
553352|NCT00861744|B5|Baseline|Total|Total of all reporting groups
553353|NCT00861744|B4|Baseline|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553354|NCT00861744|B3|Baseline|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553355|NCT00861744|B2|Baseline|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553356|NCT00861744|B1|Baseline|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553357|NCT00861744|P4|Participant Flow|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553358|NCT00861744|P3|Participant Flow|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553359|NCT00861744|P2|Participant Flow|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553556|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553557|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553558|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553360|NCT00861744|P1|Participant Flow|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553361|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553362|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553363|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553364|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553365|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553366|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553367|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553368|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553369|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553370|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553371|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553649|NCT00862082|O1|Outcome|PR104|
553372|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553373|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553374|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553375|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553376|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553377|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553378|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553379|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553380|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553381|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553382|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553383|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553384|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553385|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553386|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553387|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553388|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553389|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553390|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553391|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553392|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553393|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553394|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553395|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553396|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553397|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553398|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553399|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553400|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553401|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553402|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553403|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553404|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553405|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553406|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553407|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553408|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553409|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553410|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553411|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553412|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553413|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553414|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553415|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553416|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553417|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553418|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553419|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553420|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553421|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553422|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553423|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553424|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553425|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553426|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553427|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553428|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553429|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553430|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553431|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553432|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553433|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553434|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553435|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553436|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553437|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553438|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553439|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553440|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553441|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553442|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553443|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553444|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553445|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553446|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553447|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553448|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553449|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553450|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553451|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553452|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553453|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553454|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553455|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553456|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553457|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553458|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553459|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553460|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553461|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553462|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553463|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553464|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553465|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553466|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553467|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553468|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553469|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553470|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553471|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553472|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553473|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553474|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553475|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553476|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553477|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553478|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553479|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553480|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553481|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553482|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553483|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553484|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553485|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553486|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553487|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553488|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553489|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553490|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553491|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553492|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553493|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553494|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553495|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553496|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553497|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553498|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553499|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553500|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553501|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553502|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553503|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553504|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553505|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553506|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553507|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553508|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553509|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553510|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553511|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553512|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553513|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553514|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553515|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553516|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553517|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553518|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553519|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553520|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553521|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553522|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553523|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553524|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553525|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553526|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553527|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553528|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553529|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553530|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553531|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553532|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553533|NCT00861744|E4|Reported Event|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553534|NCT00861744|E3|Reported Event|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553535|NCT00861744|E2|Reported Event|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553536|NCT00861744|E1|Reported Event|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
553537|NCT00861757|B5|Baseline|Total|Total of all reporting groups
553538|NCT00861757|B4|Baseline|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553539|NCT00861757|B3|Baseline|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553540|NCT00861757|B2|Baseline|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553541|NCT00861757|B1|Baseline|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553542|NCT00861757|P4|Participant Flow|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553543|NCT00861757|P3|Participant Flow|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553544|NCT00861757|P2|Participant Flow|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553545|NCT00861757|P1|Participant Flow|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553546|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553547|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553548|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553549|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553550|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553551|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553559|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553560|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553561|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553562|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553563|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553564|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553565|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553566|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553567|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553568|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553569|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553570|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553571|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553572|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553573|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553574|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553575|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553576|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553577|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553578|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553579|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553580|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553581|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553582|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553583|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553584|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553585|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553586|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553587|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553588|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553589|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553590|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
553591|NCT00861757|O3|Outcome|5 mg Tadalafil|Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
553592|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
553593|NCT00861757|O1|Outcome|Placebo|Drug: Placebo PO, QD (30min after meal) for 12 weeks
553594|NCT00861757|E4|Reported Event|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
553595|NCT00861757|E3|Reported Event|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553596|NCT00861757|E2|Reported Event|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
553597|NCT00861757|E1|Reported Event|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
553598|NCT00856180|B1|Baseline|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
553599|NCT00856180|P1|Participant Flow|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
553600|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
553601|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
553650|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
553651|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
553602|NCT00856180|O2|Outcome|Platinum Resistant|At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum resisistant is defined as having had a </=6 month interval since last receiving platinum therapy prior to disease recurrence.
553603|NCT00856180|O1|Outcome|Platinum Sensitive|At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum sensitive is defined as having had a >6 month interval since last receiving platinum therapy prior to disease recurrence.
553604|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
553605|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
553606|NCT00856180|E1|Reported Event|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
553607|NCT00861913|B1|Baseline|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553608|NCT00861913|P1|Participant Flow|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553609|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553610|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553611|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553612|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553613|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553614|NCT00861913|E1|Reported Event|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553615|NCT00862082|B3|Baseline|Total|Total of all reporting groups
553616|NCT00862082|B2|Baseline|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
553617|NCT00862082|B1|Baseline|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
553618|NCT00862082|P2|Participant Flow|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
553619|NCT00862082|P1|Participant Flow|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
553620|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
553621|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
553622|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
553623|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
553624|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
553625|NCT00862082|O1|Outcome|PR104|
553626|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
553627|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
553628|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
553629|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
553630|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
553631|NCT00862082|O1|Outcome|PR104|
553632|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
553633|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
553634|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
553635|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
553636|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
553637|NCT00862082|O1|Outcome|PR104|
553638|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
553639|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
553640|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
553641|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
553642|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
553643|NCT00862082|O1|Outcome|PR104|
553644|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
553645|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
553646|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
553647|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
553648|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
553656|NCT00862082|O2|Outcome|Cohort 2|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
553657|NCT00862082|O1|Outcome|Cohort 1|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
553658|NCT00862082|O1|Outcome|Cohorts 1 and 2|770 and 550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
553659|NCT00862082|E2|Reported Event|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
553660|NCT00862082|E1|Reported Event|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
553661|NCT00862121|B3|Baseline|Total|Total of all reporting groups
553662|NCT00862121|B2|Baseline|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553663|NCT00862121|B1|Baseline|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553664|NCT00862121|P2|Participant Flow|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553665|NCT00862121|P1|Participant Flow|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553666|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553667|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553668|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553669|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553670|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553671|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553672|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553673|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553674|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553675|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553676|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553677|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553678|NCT00862121|E2|Reported Event|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553679|NCT00862121|E1|Reported Event|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
553680|NCT00862134|B3|Baseline|Total|Total of all reporting groups
553681|NCT00862134|B2|Baseline|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
553682|NCT00862134|B1|Baseline|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
553683|NCT00862134|P2|Participant Flow|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic Granulocyte Colony-stimulating Factor (G-CSF).
553684|NCT00862134|P1|Participant Flow|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
553685|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
553686|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
553687|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
553688|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
553689|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
553690|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
553691|NCT00862134|E2|Reported Event|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
553692|NCT00862134|E1|Reported Event|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
553693|NCT00862186|B1|Baseline|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
553694|NCT00862186|P1|Participant Flow|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
553695|NCT00862186|O2|Outcome|Resource Helpfulness|Fatigue Facts & Fixes was assessed for amount of resource helpfulness on a 1-5 Likert-type scale.
553696|NCT00862186|O1|Outcome|Resource Use|Fatigue Facts & Fixes was assessed for amount of resource use on a 1-5 Likert-type scale.
553738|NCT00864916|B2|Baseline|Placebo+cART|"Participants will receive placebo and cART.
Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)
Placebo: Participants will receive placebo three times per day for 48 weeks."
553953|NCT00865904|E5|Reported Event|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553697|NCT00862186|E1|Reported Event|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
553698|NCT00864851|B4|Baseline|Total|Total of all reporting groups
553699|NCT00864851|B3|Baseline|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553700|NCT00864851|B2|Baseline|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553701|NCT00864851|B1|Baseline|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553702|NCT00864851|P3|Participant Flow|Replagal 0.4 mg/kg, IV, Weekly|Patients randomized to receive Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553703|NCT00864851|P2|Participant Flow|Replagal 0.2 mg/kg, IV, Weekly|Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553704|NCT00864851|P1|Participant Flow|Replagal 0.2 mg/kg, IV, Every Other Week|Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553705|NCT00864851|O4|Outcome|Overall|Total of all reporting groups.
553706|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553707|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553708|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553709|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553710|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553711|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553712|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553713|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553714|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553715|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553716|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553717|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553718|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553719|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553720|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553721|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553722|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553723|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553724|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553725|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553726|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553727|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553728|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553729|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553730|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553731|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553732|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553733|NCT00864851|E4|Reported Event|Overall|Total of all reporting groups.
553734|NCT00864851|E3|Reported Event|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
553735|NCT00864851|E2|Reported Event|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
553736|NCT00864851|E1|Reported Event|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
553737|NCT00864916|B3|Baseline|Total|Total of all reporting groups
553806|NCT00865124|E1|Reported Event|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
553739|NCT00864916|B1|Baseline|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).
Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)
Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
553740|NCT00864916|P2|Participant Flow|Placebo+cART|"Participants will receive placebo and cART.
Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)
Placebo: Participants will receive placebo three times per day for 48 weeks."
553741|NCT00864916|P1|Participant Flow|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).
Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)
Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
553742|NCT00864916|O2|Outcome|Placebo+cART|"Participants will receive placebo and cART.
Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)
Placebo: Participants will receive placebo three times per day for 48 weeks."
553743|NCT00864916|O1|Outcome|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).
Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)
Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
553744|NCT00864916|E2|Reported Event|Placebo+cART|"Participants will receive placebo and cART.
Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)
Placebo: Participants will receive placebo three times per day for 48 weeks."
553745|NCT00864916|E1|Reported Event|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).
Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)
Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
553746|NCT00865020|B3|Baseline|Total|Total of all reporting groups
553747|NCT00865020|B2|Baseline|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
553748|NCT00865020|B1|Baseline|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
553749|NCT00865020|P2|Participant Flow|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
553750|NCT00865020|P1|Participant Flow|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
553751|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
553752|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
553753|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
553754|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
553755|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
553756|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
553757|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
553758|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
553807|NCT00865189|B3|Baseline|Total|Total of all reporting groups
560090|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
553759|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
553760|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
553761|NCT00865020|E2|Reported Event|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
553762|NCT00865020|E1|Reported Event|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
553763|NCT00865046|B4|Baseline|Total|Total of all reporting groups
553764|NCT00865046|B3|Baseline|Arm 3|"control-PST for 10 weeks
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
553765|NCT00865046|B2|Baseline|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
553766|NCT00865046|B1|Baseline|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
553767|NCT00865046|P3|Participant Flow|Arm 3|"control-PST for 10 weeks
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
553768|NCT00865046|P2|Participant Flow|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
553769|NCT00865046|P1|Participant Flow|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
553770|NCT00865046|O3|Outcome|Arm 3|"control-PST for 10 weeks
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
553771|NCT00865046|O2|Outcome|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
553772|NCT00865046|O1|Outcome|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
553773|NCT00865046|E3|Reported Event|Arm 3|"control-PST for 10 weeks
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
553774|NCT00865046|E2|Reported Event|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
553775|NCT00865046|E1|Reported Event|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
553776|NCT00865098|B1|Baseline|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
553857|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
553858|NCT00865306|O1|Outcome|Active CBT|
553859|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
553860|NCT00865306|O1|Outcome|Active CBT|
553861|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
553862|NCT00865306|O1|Outcome|Active CBT|
553863|NCT00865306|E2|Reported Event|No Intervention (Wait-list Controls)|
553777|NCT00865098|P1|Participant Flow|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
553778|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
553779|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
553780|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
553781|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
553782|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
553783|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
553784|NCT00865098|E1|Reported Event|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
553785|NCT00865124|B4|Baseline|Total|Total of all reporting groups
553786|NCT00865124|B3|Baseline|Placebo Capsule|Placebo: Placebo capsule daily
553787|NCT00865124|B2|Baseline|Hydrochlorothiazide + Potassium|Hydrochlorothiazide + potassium: hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
553788|NCT00865124|B1|Baseline|Spironolactone (MR Blockade)|Spironolactone: 25 mg capsule daily for 6 months
553789|NCT00865124|P3|Participant Flow|Placebo|Placebo capsule daily
553790|NCT00865124|P2|Participant Flow|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 milliequivalents (mEq) capsule daily
553791|NCT00865124|P1|Participant Flow|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
553792|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
553793|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
553794|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
553795|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
553796|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
553797|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
553798|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
553799|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
553800|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
553801|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
553802|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
553803|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
553804|NCT00865124|E3|Reported Event|Placebo|Placebo capsule daily
553805|NCT00865124|E2|Reported Event|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
553864|NCT00865306|E1|Reported Event|Active CBT|
553808|NCT00865189|B2|Baseline|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553809|NCT00865189|B1|Baseline|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553810|NCT00865189|P2|Participant Flow|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553811|NCT00865189|P1|Participant Flow|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (intravenous [IV] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the total mesorectal excision (TME) technique.
553812|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553813|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553814|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553815|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553816|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553817|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553865|NCT00865345|B1|Baseline|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
553866|NCT00865345|P1|Participant Flow|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
553867|NCT00865345|O1|Outcome|All Completed Subjects|All subjects that completed the inpatient frequent sampling procedure.
553868|NCT00865345|O1|Outcome|All Completed Subjects|All subjects that completed the inpatient frequent sampling procedure.
560091|NCT00882687|O4|Outcome|Placebo|
553818|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553819|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553820|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553821|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553822|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553823|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553824|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553825|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553826|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553827|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553869|NCT00865345|E1|Reported Event|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
553870|NCT00865514|B1|Baseline|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
553828|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553829|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553830|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553831|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553832|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553833|NCT00865189|E2|Reported Event|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
553834|NCT00865189|E1|Reported Event|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
553835|NCT00865202|B3|Baseline|Total|Total of all reporting groups
553836|NCT00865202|B2|Baseline|Placebo|similar appearing placebo
553837|NCT00865202|B1|Baseline|L-tryptophan|L-tryptophan 1 gm enterally TID starting the evening of the operation
553838|NCT00865202|P2|Participant Flow|Placebo|Similar appearing placebo
553839|NCT00865202|P1|Participant Flow|Study Drug|L-tryptophan 1 gm enterally TID starting the evening of the operation
553840|NCT00865202|O2|Outcome|Placebo|Similar appearing placebo
553841|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
553842|NCT00865202|O2|Outcome|Placebo|Similar appearing placebo
553843|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
553844|NCT00865202|O2|Outcome|Placebo|similar appearing placebo
553845|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
553846|NCT00865202|O2|Outcome|Placebo|similar appearing placebo
553847|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
553848|NCT00865202|O2|Outcome|Placebo|similar appearing placebo
553849|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
553850|NCT00865202|E2|Reported Event|Placebo|Similar appearing placebo
553851|NCT00865202|E1|Reported Event|Study Drug|L-tryptophan 1 gm enterally TID starting the evening of the operation
553852|NCT00865306|B3|Baseline|Total|Total of all reporting groups
553853|NCT00865306|B2|Baseline|No Intervention (Wait-list Controls)|
553854|NCT00865306|B1|Baseline|Active CBT|
553855|NCT00865306|P2|Participant Flow|No Intervention (Wait-list Controls)|This was a 6-month wait-list control condition in which children received no intervention. After participating in the control condition, families who wanted it were offered the opportunity to receive the CBT intervention.
553856|NCT00865306|P1|Participant Flow|Active CBT|This was parent-child CBT, administered to families individually over 6 months, and including six 1-hour parent-only sessions, followed by 8-13 1-hour child-parent sessions, and one final 1-hour parent-only session.
553871|NCT00865514|P1|Participant Flow|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
553872|NCT00865514|O1|Outcome|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
553873|NCT00865514|O1|Outcome|The Interaction of DCA and/or Tyrosine Breakdown Products|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
553874|NCT00865514|E1|Reported Event|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
553875|NCT00865709|B3|Baseline|Total|Total of all reporting groups
553876|NCT00865709|B2|Baseline|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
553877|NCT00865709|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
553878|NCT00865709|P2|Participant Flow|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
553879|NCT00865709|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
553880|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
553881|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
553882|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
553883|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
553884|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
553885|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
553886|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
553887|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
553888|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
553889|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
553890|NCT00865709|E4|Reported Event|Matching Placebo + mFOLFOX6 (OS Update)|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
553891|NCT00865709|E3|Reported Event|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (OS Update)|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
560092|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
553892|NCT00865709|E2|Reported Event|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
553893|NCT00865709|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
553894|NCT00865904|B6|Baseline|Total|Total of all reporting groups
553895|NCT00865904|B5|Baseline|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553896|NCT00865904|B4|Baseline|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553897|NCT00865904|B3|Baseline|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553898|NCT00865904|B2|Baseline|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553899|NCT00865904|B1|Baseline|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
553900|NCT00865904|P5|Participant Flow|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553901|NCT00865904|P4|Participant Flow|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553902|NCT00865904|P3|Participant Flow|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553903|NCT00865904|P2|Participant Flow|VX-809, 25 mg|VX-809, 25 milligram (mg) capsule orally once daily for 28 days.
553904|NCT00865904|P1|Participant Flow|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
553905|NCT00865904|O4|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553906|NCT00865904|O3|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553907|NCT00865904|O2|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553908|NCT00865904|O1|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553909|NCT00865904|O4|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553910|NCT00865904|O3|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553911|NCT00865904|O2|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553912|NCT00865904|O1|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553913|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553914|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553915|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553916|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553917|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
553918|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553919|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553920|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553921|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553922|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
553923|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553924|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553925|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553926|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553927|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
553928|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553929|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553930|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553931|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553932|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
553933|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553934|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553935|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553936|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553937|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
553938|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553939|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553940|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553941|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553942|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
553943|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553944|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553945|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553946|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553947|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
553948|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
553949|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553950|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553951|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553952|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
553954|NCT00865904|E4|Reported Event|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
553955|NCT00865904|E3|Reported Event|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
553956|NCT00865904|E2|Reported Event|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
553957|NCT00865904|E1|Reported Event|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
553958|NCT00866034|B3|Baseline|Total|Total of all reporting groups
553959|NCT00866034|B2|Baseline|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
553960|NCT00866034|B1|Baseline|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
553961|NCT00866034|P2|Participant Flow|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
553962|NCT00866034|P1|Participant Flow|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
553963|NCT00866034|O2|Outcome|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
553964|NCT00866034|O1|Outcome|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
553965|NCT00866034|O2|Outcome|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
553966|NCT00866034|O1|Outcome|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
553967|NCT00866034|E2|Reported Event|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
553968|NCT00866034|E1|Reported Event|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
553969|NCT00866047|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553970|NCT00866047|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
553971|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553972|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553973|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553974|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553975|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553976|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553977|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553978|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553979|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553980|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553981|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553982|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553983|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553984|NCT00866047|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
553985|NCT00866177|B1|Baseline|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553986|NCT00866177|P1|Participant Flow|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553987|NCT00866177|O1|Outcome|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553988|NCT00866177|E1|Reported Event|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
553989|NCT00866281|B3|Baseline|Total|Total of all reporting groups
553990|NCT00866281|B2|Baseline|Cohort 2: Midostaurin (60 mg/m^2)|Participants received body-weight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
553991|NCT00866281|B1|Baseline|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received body-weight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
553992|NCT00866281|P2|Participant Flow|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
553993|NCT00866281|P1|Participant Flow|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m^2 twice daily (bid) through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
553994|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
553995|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
554139|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
553996|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
553997|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
553998|NCT00866281|O2|Outcome|MLLr­ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
553999|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
554000|NCT00866281|O2|Outcome|MLLr­ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
554001|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
554002|NCT00866281|O2|Outcome|MLLr-ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
554003|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
554004|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
554005|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
554006|NCT00866281|E2|Reported Event|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
554007|NCT00866281|E1|Reported Event|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
554008|NCT00866294|B4|Baseline|Total|Total of all reporting groups
554009|NCT00866294|B3|Baseline|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
554010|NCT00866294|B2|Baseline|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
554011|NCT00866294|B1|Baseline|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
554012|NCT00866294|P3|Participant Flow|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
554013|NCT00866294|P2|Participant Flow|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
554014|NCT00866294|P1|Participant Flow|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
554015|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554078|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
554140|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554016|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554017|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
554018|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554019|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554020|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
554021|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554022|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554023|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
554024|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554025|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554026|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
554027|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554028|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554029|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
554030|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554031|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
554032|NCT00866294|O1|Outcome|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
554033|NCT00866294|E7|Reported Event|Paroxetine IR, Total|All participants receiving either paroxetine IR 10-40 mg/day or 20-40 mg/day
554034|NCT00866294|E6|Reported Event|Paroxetine IR 20-40 mg/Day|An initial dose of 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
554035|NCT00866294|E5|Reported Event|Paroxetine IR 10-40 mg/Day|An initial dose of 10 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 20 mg/day, and 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
554036|NCT00866294|E4|Reported Event|Paroxetine CR, Total|All participants receiving either paroxetine CR 12.5-50 mg/day or 25-50 mg/day
554037|NCT00866294|E3|Reported Event|Paroxetine CR 25-50 mg/Day|An initial dose of 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
554038|NCT00866294|E2|Reported Event|Paroxetine CR 12.5-50 mg/Day|An initial dose of 12.5 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 25 mg/day, and 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
554039|NCT00866294|E1|Reported Event|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
554040|NCT00866307|B1|Baseline|Induction|All Patients
554041|NCT00866307|P3|Participant Flow|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
554042|NCT00866307|P2|Participant Flow|Group A (High Risk-Average)|Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM)
554043|NCT00866307|P1|Participant Flow|Induction|All Patients
554044|NCT00866307|O1|Outcome|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
554045|NCT00866307|O1|Outcome|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
554046|NCT00866307|E3|Reported Event|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy.
554047|NCT00866307|E2|Reported Event|Group A (High Risk-Average)|Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM).
554048|NCT00866307|E1|Reported Event|Induction|All Patients
554049|NCT00866320|B1|Baseline|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
554050|NCT00866320|P1|Participant Flow|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
554051|NCT00866320|O1|Outcome|Sorafenib|Patients receive Sorafenib twice a day until disease progression or toxicity
554052|NCT00866320|O1|Outcome|Sorafenib|Sorafenib twice a day until progression or toxicity
554053|NCT00866320|O1|Outcome|Sorafenib|Patients receive sorafenib twice a day until disease progression or toxicity.
554054|NCT00866320|O1|Outcome|Sorafenib|Patients receive sorafenib twice a day until disease progression or toxicity.
554055|NCT00866320|E1|Reported Event|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
554056|NCT00866359|B3|Baseline|Total|Total of all reporting groups
554057|NCT00866359|B2|Baseline|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554058|NCT00866359|B1|Baseline|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
554059|NCT00866359|P4|Participant Flow|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast BID tablets in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
554060|NCT00866359|P3|Participant Flow|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
554061|NCT00866359|P2|Participant Flow|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554062|NCT00866359|P1|Participant Flow|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
554079|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
554063|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554064|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|"Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554065|NCT00866359|O2|Outcome|Apremilast 30 mg/Apremilast 30mg BID|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554066|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554067|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554068|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554069|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554070|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554071|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554072|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554073|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554074|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
554075|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Treatment and Extension Phases (Days 1 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
554076|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase
554077|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID were titrated to 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
554080|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase .
554081|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
554082|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
554083|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially administered to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
554084|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
554085|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
554086|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase
554087|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554088|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
554089|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554090|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
554091|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554092|NCT00866359|O1|Outcome|Placebo|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
554093|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554094|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
554095|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554096|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
554097|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554098|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
554099|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554100|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
554101|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554102|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
554103|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554104|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
554105|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554106|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
554107|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554108|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
554109|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
554110|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
554138|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554111|NCT00866359|E3|Reported Event|Week 24: Apremilast 30 mg BID|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, or 12), up until Week 24. Includes data through Week 24 for participants who were treated with Apremilast started at Week 0 and data from Week 12 through Week 24 for participants who were treated with Apremilast started at Week 12.
554112|NCT00866359|E2|Reported Event|Week 12: Apremilast 30 mg BID|Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase. Includes data through Week 12 for all participants randomized to 30mg Apremilast BID.
554113|NCT00866359|E1|Reported Event|Week 12: Placebo BID|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 12 for all participants randomized to placebo.
554114|NCT00866606|B1|Baseline|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554115|NCT00866606|P1|Participant Flow|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554116|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554117|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554118|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554119|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554120|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554121|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554122|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554123|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554124|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554125|NCT00866606|E1|Reported Event|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
554126|NCT00866658|B3|Baseline|Total|Total of all reporting groups
554127|NCT00866658|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
554128|NCT00866658|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
554129|NCT00866658|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
554130|NCT00866658|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
554131|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554132|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554133|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554134|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554135|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554136|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554137|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554141|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554142|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554143|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554144|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554145|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554146|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554147|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554148|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554149|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554150|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554151|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554152|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554153|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554154|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554155|NCT00866658|E2|Reported Event|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
554156|NCT00866658|E1|Reported Event|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
554157|NCT00866697|B3|Baseline|Total|Total of all reporting groups
554158|NCT00866697|B2|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554159|NCT00866697|B1|Baseline|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554160|NCT00866697|P2|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554161|NCT00866697|P1|Participant Flow|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554162|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554163|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554164|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554165|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554166|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554167|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554168|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554169|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554170|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554171|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554172|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554173|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554174|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554175|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554176|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554177|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554178|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554179|NCT00866697|O1|Outcome|Placebo|Placebo
554180|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554181|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554182|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554183|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554184|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554185|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554186|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554187|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554188|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554189|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554190|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554191|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554192|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554193|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554194|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554195|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554196|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554197|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554198|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554199|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554200|NCT00866697|E2|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
554201|NCT00866697|E1|Reported Event|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
554202|NCT00866723|B1|Baseline|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
554203|NCT00866723|P1|Participant Flow|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
554204|NCT00866723|O1|Outcome|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
554205|NCT00866723|O1|Outcome|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
554206|NCT00866723|E1|Reported Event|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
554207|NCT00866775|B3|Baseline|Total|Total of all reporting groups
554208|NCT00866775|B2|Baseline|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554209|NCT00866775|B1|Baseline|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554210|NCT00866775|P2|Participant Flow|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554211|NCT00866775|P1|Participant Flow|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554212|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554213|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554214|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554215|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554216|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554217|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554218|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554219|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554220|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554221|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554222|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554223|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554224|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554225|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554226|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554227|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554228|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554229|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554230|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554231|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554232|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554233|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554234|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554235|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554236|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554237|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554238|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554239|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554240|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554241|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554242|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554243|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554244|NCT00866775|E2|Reported Event|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
554245|NCT00866775|E1|Reported Event|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
554246|NCT00866788|B5|Baseline|Total|Total of all reporting groups
554247|NCT00866788|B4|Baseline|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554248|NCT00866788|B3|Baseline|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554249|NCT00866788|B2|Baseline|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554250|NCT00866788|B1|Baseline|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554251|NCT00866788|P4|Participant Flow|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554252|NCT00866788|P3|Participant Flow|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554253|NCT00866788|P2|Participant Flow|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554254|NCT00866788|P1|Participant Flow|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554255|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554256|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554257|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554258|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554259|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554260|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554261|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554262|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554263|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554264|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554265|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554266|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554267|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554268|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554269|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554270|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554271|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554272|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
560093|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
554273|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554274|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554275|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554276|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554277|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554278|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554279|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554280|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554281|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554282|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554283|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554284|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554285|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554286|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554287|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554288|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554289|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554290|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554291|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554292|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554486|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554293|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554294|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554295|NCT00866788|E4|Reported Event|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554296|NCT00866788|E3|Reported Event|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554297|NCT00866788|E2|Reported Event|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554298|NCT00866788|E1|Reported Event|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
554299|NCT00866814|B1|Baseline|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
554300|NCT00866814|P1|Participant Flow|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
554301|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
554302|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
554303|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
554304|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
554305|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
554306|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
554307|NCT00866814|E1|Reported Event|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
554308|NCT00866905|B1|Baseline|Arm/Group 1|
554309|NCT00866905|P1|Participant Flow|Ixabepilone/Cyclophosphamide|"Ixabepilone: 40 mg/m2 via intraveous (IV) infusion over 3 hours
Cyclophosphamide: 600 mg/m2 via IV infusion per institutional guidelines"
554310|NCT00866905|O1|Outcome|Ixabepilone/Cyclophosphamide|Systemic Therapy followed by surgery and possible radiation therapy
554311|NCT00866905|O1|Outcome|Ixabepilone/Cyclophosphamide|Systemic Therapy followed by surgery and possible radiation therapy
554312|NCT00866905|E1|Reported Event|Ixabepilone/Cyclophosphamide|
554313|NCT00866918|B3|Baseline|Total|Total of all reporting groups
554314|NCT00866918|B2|Baseline|High Risk|WBC>=10,000/MicroLiter
554315|NCT00866918|B1|Baseline|Standard Risk|WBC<10,000/MicroLiter
554316|NCT00866918|P2|Participant Flow|High Risk|WBC>=10,000/MicroLiter
554317|NCT00866918|P1|Participant Flow|Standard Risk|WBC<10,000/MicroLiter
554318|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
554319|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
554320|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
554321|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
554322|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
554323|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
554324|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
554325|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
554326|NCT00866918|E2|Reported Event|High Risk|WBC>=10,000/MicroLiter
554327|NCT00866918|E1|Reported Event|Standard Risk|WBC<10,000/MicroLiter
554328|NCT00867009|B1|Baseline|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
554329|NCT00867009|P1|Participant Flow|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
554330|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
554364|NCT00867087|B1|Baseline|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554487|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554331|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
554332|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
554333|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
554334|NCT00867009|E1|Reported Event|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
554335|NCT00867035|B3|Baseline|Total|Total of all reporting groups
554336|NCT00867035|B2|Baseline|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554337|NCT00867035|B1|Baseline|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554338|NCT00867035|P2|Participant Flow|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554339|NCT00867035|P1|Participant Flow|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554340|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554341|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554342|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554343|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554344|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554345|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554346|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554347|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554348|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554349|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554350|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554351|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554352|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554353|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554354|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554355|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554356|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554357|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554358|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554359|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554360|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554361|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554362|NCT00867035|E2|Reported Event|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
554363|NCT00867035|E1|Reported Event|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
554390|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receiveTCAD or neuraminidase inhibitor monotherapy.
554365|NCT00867087|P1|Participant Flow|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|Intravenous (IV) inotuzumab ozogamicin 1.8 milligrams per square meter (mg/m^2) given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554366|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554367|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554368|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554369|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554370|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554371|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554372|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554373|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554374|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554375|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554376|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554377|NCT00867087|E1|Reported Event|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
554378|NCT00867139|B4|Baseline|Total|Total of all reporting groups
554379|NCT00867139|B3|Baseline|Open-Labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received open-label TCAD.
554380|NCT00867139|B2|Baseline|Neuraminidase Inhibitor Monotheraphy|Neuraminidase inhibitors include zanamivir and oseltamivir phosphate in this study.
554381|NCT00867139|B1|Baseline|TCAD|This substudy was a randomized study comparing TCAD therapy and OSL monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
554382|NCT00867139|P3|Participant Flow|Open-labeled TCAD|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
554383|NCT00867139|P2|Participant Flow|Neuraminidase Inhibitor Monotherapy|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
554384|NCT00867139|P1|Participant Flow|TCAD|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
554385|NCT00867139|O3|Outcome|Open-lable TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554386|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554387|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554388|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554389|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554485|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554391|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554392|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554393|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554394|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554395|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554396|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554397|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554398|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554399|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554400|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554401|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554402|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554403|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554404|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554405|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554406|NCT00867139|O3|Outcome|Open-label TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554407|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554408|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554409|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554410|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554411|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554412|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554413|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554414|NCT00867139|O1|Outcome|TCAD|This substudy was a randomized study comparing TCAD therapy and OSL monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
554415|NCT00867139|O3|Outcome|Open-label TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554416|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554417|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554418|NCT00867139|O3|Outcome|Open-labeled TCAD|amantadine (75 mg), oseltamivir (50 mg), and ribavirin (200 mg); three times a day for 10 days
554419|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|oseltamivir (50 mg); three times a day for 10 days
554420|NCT00867139|O1|Outcome|TCAD|amantadine (75 mg), oseltamivir (50 mg), and ribavirin (200 mg); three times a day for 10 days
554421|NCT00867139|E3|Reported Event|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
554422|NCT00867139|E2|Reported Event|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554423|NCT00867139|E1|Reported Event|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
554424|NCT00867165|B3|Baseline|Total|Total of all reporting groups
554425|NCT00867165|B2|Baseline|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554426|NCT00867165|B1|Baseline|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554427|NCT00867165|P2|Participant Flow|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554428|NCT00867165|P1|Participant Flow|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554429|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554430|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554431|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554432|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554433|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554434|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554435|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554436|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554437|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554438|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554439|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554440|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554441|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554442|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554443|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554444|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554445|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554446|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554447|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554448|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554449|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554450|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554451|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554452|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554453|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554454|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554455|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554456|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554457|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554458|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554459|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554460|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554461|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554462|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554463|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554464|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554465|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554466|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554467|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554468|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554469|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554470|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554471|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554472|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554473|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554474|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554475|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554476|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554477|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554478|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554479|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554480|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554481|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554482|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554483|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554484|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554488|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554489|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554490|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554491|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554492|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554493|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554494|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554495|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554496|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554497|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554498|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554499|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554500|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554501|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554502|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554503|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554504|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554505|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554506|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554507|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554508|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554509|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554510|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554511|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554512|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554513|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554514|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554515|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554516|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554517|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554518|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554519|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554520|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554521|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554522|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554523|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554524|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554525|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554526|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554527|NCT00867165|E2|Reported Event|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
554528|NCT00867165|E1|Reported Event|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
554529|NCT00859027|B3|Baseline|Total|Total of all reporting groups
554530|NCT00859027|B2|Baseline|Calcium and Vitamin D|
554531|NCT00859027|B1|Baseline|Risedronate Plus Calcium and Vit D|
554532|NCT00859027|P2|Participant Flow|Calcium and Vitamin D Daily (Placebo Group)|
554533|NCT00859027|P1|Participant Flow|Risedronate 35 mg p.o.Every Week Plus Calcium and Vit D Daily|
554534|NCT00859027|O2|Outcome|Calcium and Vitamin D-Spine|
554535|NCT00859027|O1|Outcome|Risedronate - Spine|
554536|NCT00859027|E2|Reported Event|Risedronate|Particiapnts given 35 mg by mouth every week
554537|NCT00859027|E1|Reported Event|CAlcium and Vitamin D|
554538|NCT00859040|B3|Baseline|Total|Total of all reporting groups
554539|NCT00859040|B2|Baseline|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554540|NCT00859040|B1|Baseline|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554541|NCT00859040|P2|Participant Flow|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554542|NCT00859040|P1|Participant Flow|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554543|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554544|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554545|NCT00859040|O1|Outcome|SOM230C|"Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)
SOM230C: Injection in the buttocks every 28 days"
554546|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554547|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554548|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554549|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554550|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554551|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
554552|NCT00859040|E1|Reported Event|SOM230C|"Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)
SOM230C: Injection in the buttocks every 28 days"
554553|NCT00859053|B5|Baseline|Total|Total of all reporting groups
554554|NCT00859053|B4|Baseline|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554555|NCT00859053|B3|Baseline|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554556|NCT00859053|B2|Baseline|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554557|NCT00859053|B1|Baseline|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554558|NCT00859053|P4|Participant Flow|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554559|NCT00859053|P3|Participant Flow|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554560|NCT00859053|P2|Participant Flow|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554561|NCT00859053|P1|Participant Flow|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 milligrams (mg) (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554562|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554563|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554564|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554565|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554566|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554567|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554568|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554569|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554570|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554571|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554572|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554573|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554574|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554575|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554576|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554577|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554578|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
555654|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
554579|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554580|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554581|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554582|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554583|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554584|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554585|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554586|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554587|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554588|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554589|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554590|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554591|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554592|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554593|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554594|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554595|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554596|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554597|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554598|NCT00859053|E4|Reported Event|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554599|NCT00859053|E3|Reported Event|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554600|NCT00859053|E2|Reported Event|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554601|NCT00859053|E1|Reported Event|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
554602|NCT00859131|B3|Baseline|Total|Total of all reporting groups
554603|NCT00859131|B2|Baseline|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
554604|NCT00859131|B1|Baseline|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation
Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
554605|NCT00859131|P2|Participant Flow|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
554606|NCT00859131|P1|Participant Flow|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation
Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
554607|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
554608|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation
Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
554609|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
554610|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation
Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
554611|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
554612|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation
Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
554613|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
556228|NCT00863707|B1|Baseline|Placebo|Matching intravenous (IV) bolus injection
554614|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation
Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
554615|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
554616|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation
Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
554617|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
554618|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation
Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
554619|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
554620|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation
Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
554621|NCT00859131|E2|Reported Event|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
554622|NCT00859131|E1|Reported Event|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation
Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
554623|NCT00859222|B4|Baseline|Total|Total of all reporting groups
554624|NCT00859222|B3|Baseline|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554625|NCT00859222|B2|Baseline|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554626|NCT00859222|B1|Baseline|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
554627|NCT00859222|P5|Participant Flow|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554628|NCT00859222|P4|Participant Flow|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554629|NCT00859222|P3|Participant Flow|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554630|NCT00859222|P2|Participant Flow|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554631|NCT00859222|P1|Participant Flow|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
554632|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
554633|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554634|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554635|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
554636|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
554637|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554638|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554639|NCT00859222|O5|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554640|NCT00859222|O4|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554641|NCT00859222|O3|Outcome|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554642|NCT00859222|O2|Outcome|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554643|NCT00859222|O1|Outcome|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
554644|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554645|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554646|NCT00859222|O3|Outcome|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554647|NCT00859222|O2|Outcome|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554648|NCT00859222|O1|Outcome|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
554649|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
554650|NCT00859222|E5|Reported Event|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554651|NCT00859222|E4|Reported Event|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554652|NCT00859222|E3|Reported Event|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554653|NCT00859222|E2|Reported Event|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
554654|NCT00859222|E1|Reported Event|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
554655|NCT00859313|B1|Baseline|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
554656|NCT00859313|P1|Participant Flow|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
560094|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
554657|NCT00859313|O1|Outcome|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
554658|NCT00859313|E1|Reported Event|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
554659|NCT00859339|B1|Baseline|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
554660|NCT00859339|P1|Participant Flow|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
554661|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
554662|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
554663|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
554664|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
554665|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
554666|NCT00859339|E1|Reported Event|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
554667|NCT00867321|B4|Baseline|Total|Total of all reporting groups
554668|NCT00867321|B3|Baseline|All Phase I Patients|This includes all patients who participated in the phase I dose escalation portion of the trial.
554669|NCT00867321|B2|Baseline|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
554670|NCT00867321|B1|Baseline|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
554671|NCT00867321|P6|Participant Flow|Phase I: Dose Level -2|"Patients receive: > > Oral 200 mg BID Sorafenib days 1-28 >
> 1.25 mg/kg Bevacizumab IV on days 1, 15"
554672|NCT00867321|P5|Participant Flow|Phase I: Dose Level -2a|"Patients receive: > > Oral 200 mg BID Sorafenib days 1-28 >
> 2.5 mg/kg Bevacizumab IV on days 1, 15"
554673|NCT00867321|P4|Participant Flow|Phase I: Dose Level -1|"Patients receive: > > Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days >
> 1.25 mg/kg Bevacizumab IV on days 1, 15"
554674|NCT00867321|P3|Participant Flow|Phase I: Dose Level 0|"Patients receive: > > Oral 400 mg BID Sorafenib on days 1-28. >
> 1.25 mg/kg Bevacizumab IV on days 1, 15."
554675|NCT00867321|P2|Participant Flow|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
554676|NCT00867321|P1|Participant Flow|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
554677|NCT00867321|O2|Outcome|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
554678|NCT00867321|O1|Outcome|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
554679|NCT00867321|O2|Outcome|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
554680|NCT00867321|O1|Outcome|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
554681|NCT00867321|O2|Outcome|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
554682|NCT00867321|O1|Outcome|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
554683|NCT00867321|O4|Outcome|Phase I: Dose Level -2|"Patients receive:
>
> Oral 200 mg BID Sorafenib days 1-28
>
> 1.25 mg/kg Bevacizumab IV on days 1, 15"
554684|NCT00867321|O3|Outcome|Phase I: Dose Level -2a (Maximum Tolerated Dose)|"Patients receive:
>
> Oral 200 mg BID Sorafenib days 1-28
>
> 2.5 mg/kg Bevacizumab IV on days 1, 15"
554685|NCT00867321|O2|Outcome|Phase I: Dose Level -1|"Patients receive:
>
> Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days
>
> 1.25 mg/kg Bevacizumab IV on days 1, 15"
554686|NCT00867321|O1|Outcome|Phase I: Dose Level 0|"Patients receive:
>
> Oral 400 mg BID Sorafenib on days 1-28.
>
> 1.25 mg/kg Bevacizumab IV on days 1, 15."
554687|NCT00867321|E6|Reported Event|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
554688|NCT00867321|E5|Reported Event|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
554927|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
554689|NCT00867321|E4|Reported Event|Phase I: Dose Level -2|"Patients receive:
Oral 200 mg BID Sorafenib days 1-28
1.25 mg/kg Bevacizumab IV on days 1, 15"
554690|NCT00867321|E3|Reported Event|Phase I: Dose Level -2a|"Patients receive:
Oral 200 mg BID Sorafenib days 1-28
2.5 mg/kg Bevacizumab IV on days 1, 15"
554691|NCT00867321|E2|Reported Event|Phase I: Dose Level -1|"Patients receive:
Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days
1.25 mg/kg Bevacizumab IV on days 1, 15"
554692|NCT00867321|E1|Reported Event|Phase I: Dose Level 0|"Patients receive:
Oral 400 mg BID Sorafenib on days 1-28.
1.25 mg/kg Bevacizumab IV on days 1, 15"
554693|NCT00867360|B3|Baseline|Total|Total of all reporting groups
554694|NCT00867360|B2|Baseline|Placebo|"Receive placebo rather than mifepristone
Placebo: Placebo medication"
554695|NCT00867360|B1|Baseline|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days
Mifepristone (RU-486)"
554696|NCT00867360|P2|Participant Flow|Placebo|"Receive placebo rather than mifepristone
Placebo: Placebo medication"
554697|NCT00867360|P1|Participant Flow|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days
Mifepristone (RU-486)"
554698|NCT00867360|O2|Outcome|Placebo|"Receive placebo rather than mifepristone
Placebo: Placebo medication"
554699|NCT00867360|O1|Outcome|Mifepristone|"Receive 600 or 1200 mg/ day of mifepristone for 8 days
Mifepristone (RU-486)"
554700|NCT00867360|O2|Outcome|Placebo|"Receive placebo rather than mifepristone
Placebo: Placebo medication"
554701|NCT00867360|O1|Outcome|Mifepristone|"Receive 600 or 1200 mg/ day of mifepristone for 8 days
Mifepristone (RU-486)"
554702|NCT00867360|O2|Outcome|Placebo|"Receive placebo rather than mifepristone
Placebo: Placebo medication"
554703|NCT00867360|O1|Outcome|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days
Mifepristone (RU-486)"
554704|NCT00867360|E2|Reported Event|Placebo|"Receive placebo rather than mifepristone
Placebo: Placebo medication"
554705|NCT00867360|E1|Reported Event|Mifepristone|"Receive 600 or 1200 mg/ day of mifepristone for 8 days
Mifepristone (RU-486)"
554706|NCT00867451|B3|Baseline|Total|Total of all reporting groups
554707|NCT00867451|B2|Baseline|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
554708|NCT00867451|B1|Baseline|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
554709|NCT00867451|P2|Participant Flow|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
554710|NCT00867451|P1|Participant Flow|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
554711|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delays treatment participants).
554712|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delays treatment participants).
554713|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delays treatment participants).
554714|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delays treatment participants).
554715|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed treatment participants).
554716|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delayed treatment participants).
554717|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed treatment participants).
554718|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delayed treatment participants).
554719|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
554720|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
554721|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
554722|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
554723|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
554724|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
554725|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
554726|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
554746|NCT00867503|B1|Baseline|Bendamustine|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
554727|NCT00867451|E2|Reported Event|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
554728|NCT00867451|E1|Reported Event|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
554729|NCT00867490|B1|Baseline|Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine|4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.
554730|NCT00867490|P1|Participant Flow|Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine|4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.
554731|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
554732|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
554733|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
554734|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
554735|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
554736|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
554737|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
554738|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
554739|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
554740|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
554741|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
554742|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
554743|NCT00867490|E3|Reported Event|Phase 3 - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am.
554744|NCT00867490|E2|Reported Event|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
554745|NCT00867490|E1|Reported Event|Phase 1 - Candesartan+HCTZ|4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide (HCTZ) 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am.
554747|NCT00867503|P1|Participant Flow|Bendamustine|Bendamustine Hydrochloride (HCL) 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
554748|NCT00867503|O1|Outcome|Median Overall Survival in Days|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
554749|NCT00867503|O1|Outcome|Bendamustine Grade 4 Toxicity|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
554750|NCT00867503|O1|Outcome|Bendamustine Median Progression Free Surivial in Months|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
554751|NCT00867503|E1|Reported Event|Bendamustine|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
554752|NCT00867529|B1|Baseline|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
554753|NCT00867529|P1|Participant Flow|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
554754|NCT00867529|O1|Outcome|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
554755|NCT00867529|O1|Outcome|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
554756|NCT00867529|E1|Reported Event|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
554757|NCT00867568|B1|Baseline|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
554758|NCT00867568|P1|Participant Flow|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
554759|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
554760|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
554761|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
556229|NCT00863707|P2|Participant Flow|Regadenoson|0.4 mg/5 mL intravenous bolus injection
554762|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
554763|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
554764|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
554765|NCT00867568|E1|Reported Event|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
554766|NCT00869349|B3|Baseline|Total|Total of all reporting groups
554767|NCT00869349|B2|Baseline|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
554768|NCT00869349|B1|Baseline|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.
Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
554769|NCT00869349|P2|Participant Flow|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
554770|NCT00869349|P1|Participant Flow|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.
Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
554771|NCT00869349|O2|Outcome|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
554772|NCT00869349|O1|Outcome|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.
Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
554773|NCT00869349|O2|Outcome|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
554774|NCT00869349|O1|Outcome|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.
Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
554775|NCT00869349|O2|Outcome|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
554808|NCT00869401|P2|Participant Flow|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
556230|NCT00863707|P1|Participant Flow|Placebo|Matching intravenous (IV) bolus injection
554776|NCT00869349|O1|Outcome|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.
Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
554777|NCT00869349|E2|Reported Event|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
554778|NCT00869349|E1|Reported Event|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.
Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
554779|NCT00869362|B3|Baseline|Total|Total of all reporting groups
554780|NCT00869362|B2|Baseline|Control|Patients receive usual care for diabetes
554781|NCT00869362|B1|Baseline|Diabetes Management Team|Evaluation and management by diabetes management team
554782|NCT00869362|P2|Participant Flow|Control|Patients receive usual care for diabetes
554783|NCT00869362|P1|Participant Flow|Diabetes Management Team|Evaluation and management by diabetes management team including physician and nurse practitioner CDE. Physician performed diabetes medication initiation and/or titration and nurse performed CDE focusing on Diabetes Survival Skills.
554784|NCT00869362|O2|Outcome|Control|Patients receive usual care for diabetes
554785|NCT00869362|O1|Outcome|Diabetes Management Team|Evaluation and management by diabetes management team
554786|NCT00869362|O2|Outcome|Control|Patients receive usual care for diabetes
554787|NCT00869362|O1|Outcome|Diabetes Management Team|Evaluation and management by diabetes management team (physician, nurse practitioner CDE) with physician-initiation and titration of diabetes medication and nurse CDE education on Diabetes Survival Skills.
554788|NCT00869362|E2|Reported Event|Control|Patients receive usual care for diabetes
554789|NCT00869362|E1|Reported Event|Diabetes Management Team|Evaluation and management by diabetes management team
554790|NCT00869375|B3|Baseline|Total|Total of all reporting groups
554791|NCT00869375|B2|Baseline|ANGIOJET GROUP|3 patients were randomized in this group
554792|NCT00869375|B1|Baseline|CLEARWAY GROUP|3 patients were randomized in this group.
554793|NCT00869375|P2|Participant Flow|ANGIOJET GROUP|3 patients were randomized in this group
554794|NCT00869375|P1|Participant Flow|CLEARWAY GROUP|3 patients were randomized in this group.
554795|NCT00869375|O2|Outcome|ANGIOJET GROUP|3 patients were randomized in this group
554796|NCT00869375|O1|Outcome|CLEARWAY GROUP|4 patients were randomized in this group. One patient was excluded since intervention was not required.
554797|NCT00869375|O2|Outcome|ANGIOJET GROUP|No patients had distal embolization
554798|NCT00869375|O1|Outcome|CLEARWAY GROUP|No patients had distal embolization
554799|NCT00869375|E2|Reported Event|ANGIOJET GROUP|3 patients were randomized in this group
554800|NCT00869375|E1|Reported Event|CLEARWAY GROUP|4 patients were randomized in this group. One patient was excluded since intervention was not required.
554801|NCT00869401|B4|Baseline|Total|Total of all reporting groups
554802|NCT00869401|B3|Baseline|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
554803|NCT00869401|B2|Baseline|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
554804|NCT00869401|B1|Baseline|Phase I|All patients included in the Phase I portion of the study were published together for this results portion.
554805|NCT00869401|P5|Participant Flow|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
554806|NCT00869401|P4|Participant Flow|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
554807|NCT00869401|P3|Participant Flow|Dose Level 1 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
554809|NCT00869401|P1|Participant Flow|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 50 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
554810|NCT00869401|O2|Outcome|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
554811|NCT00869401|O1|Outcome|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
554812|NCT00869401|O2|Outcome|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
554813|NCT00869401|O1|Outcome|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
554814|NCT00869401|O3|Outcome|Dose Level 1 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
554815|NCT00869401|O2|Outcome|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
554816|NCT00869401|O1|Outcome|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 50 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
554817|NCT00869401|O2|Outcome|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
554818|NCT00869401|O1|Outcome|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
554819|NCT00869401|E5|Reported Event|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
554820|NCT00869401|E4|Reported Event|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
554821|NCT00869401|E3|Reported Event|Dose Level 1 Phase1|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
554822|NCT00869401|E2|Reported Event|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib100 mg/day until progression.
554823|NCT00869401|E1|Reported Event|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
554824|NCT00869414|B1|Baseline|All Study Participants|Participants were randomized to receive one of the three interventions: Insulin glargine only in the morning, Insulin glargine only in the evening, or a split dose of insulin glargine (half the dose in the morning and the other half in the evening).
554928|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
554825|NCT00869414|P3|Participant Flow|Split Dose Insulin Glargine|"Split dose administration of insulin glargine, half dose in morning, half dose in evening
split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening"
554826|NCT00869414|P2|Participant Flow|Insulin Glargine Only at Evening|"Evening only administration of insulin glargine
Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning."
554827|NCT00869414|P1|Participant Flow|Insulin Glargine Only in Morning|"Morning only administration of insulin glargine
Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night."
554828|NCT00869414|O3|Outcome|Split Dose Insulin Glargine|"Split dose administration of insulin glargine, half dose in morning, half dose in evening
split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening"
554829|NCT00869414|O2|Outcome|Insulin Glargine Only at Evening|"Evening only administration of insulin glargine
Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning."
554830|NCT00869414|O1|Outcome|Insulin Glargine Only in Morning|"Morning only administration of insulin glargine
Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night."
554831|NCT00869414|O3|Outcome|Split Dose Insulin Glargine|"Split dose administration of insulin glargine, half dose in morning, half dose in evening
split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening"
554832|NCT00869414|O2|Outcome|Insulin Glargine Only at Evening|"Evening only administration of insulin glargine
Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning."
554833|NCT00869414|O1|Outcome|Insulin Glargine Only in Morning|"Morning only administration of insulin glargine
Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night."
554834|NCT00869414|E3|Reported Event|Split Dose Insulin Glargine|"Split dose administration of insulin glargine, half dose in morning, half dose in evening
split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening"
554835|NCT00869414|E2|Reported Event|Insulin Glargine Only at Evening|"Evening only administration of insulin glargine
Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning."
554836|NCT00869414|E1|Reported Event|Insulin Glargine Only in Morning|"Morning only administration of insulin glargine
Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night."
554837|NCT00869518|B3|Baseline|Total|Total of all reporting groups
554838|NCT00869518|B2|Baseline|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole
placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554839|NCT00869518|B1|Baseline|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole
rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554840|NCT00869518|P2|Participant Flow|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole
placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554841|NCT00869518|P1|Participant Flow|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole
rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554842|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole
placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554843|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole
rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554844|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole
placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554845|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole
rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554846|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole
placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554847|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole
rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554848|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole
placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554849|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole
rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554850|NCT00869518|E2|Reported Event|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole
placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554929|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
554851|NCT00869518|E1|Reported Event|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole
rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
554852|NCT00869557|B3|Baseline|Total|Total of all reporting groups
554853|NCT00869557|B2|Baseline|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
554854|NCT00869557|B1|Baseline|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
554855|NCT00869557|P2|Participant Flow|Atripla|Atripla (efavirenz [EFV] 150 mg/FTC 200 mg/TDF 300 mg) QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
554856|NCT00869557|P1|Participant Flow|Stribild|Stribild (elvitegravir [EVG] 150 mg/GS-9350 [cobicistat; COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) once daily (QD) and placebo to match Atripla once daily prior to bedtime (QHS) were administered during the double-blind phase. Stribild QD was administered during the extension phase.
554857|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
554858|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
554859|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
554860|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
554861|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
554862|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
554863|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
554864|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
554865|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
554866|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
554867|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
554868|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
554869|NCT00869557|E3|Reported Event|All Stribild|The All Stribild safety analysis set included all participants who received at least 1 dose of Stribild in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind Stribild group while they received double-blind Stribild during the randomized phase and open-label Stribild during the extension phase; adverse events collected from the open-label Stribild extension phase only from the participants who were initially randomized to the Atripla group during the randomized phase.
554870|NCT00869557|E2|Reported Event|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase.
554871|NCT00869557|E1|Reported Event|Stribild|Stribild and placebo to match Atripla were administered during the double-blind phase.
554872|NCT00869609|B3|Baseline|Total|Total of all reporting groups
554873|NCT00869609|B2|Baseline|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554874|NCT00869609|B1|Baseline|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554875|NCT00869609|P2|Participant Flow|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554876|NCT00869609|P1|Participant Flow|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554877|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554878|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554879|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554880|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554881|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554882|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554883|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554884|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554894|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554930|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
554885|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554886|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554887|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554888|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554889|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554890|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554891|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554892|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554893|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554925|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
554926|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
556231|NCT00863707|O2|Outcome|Regadenoson|0.4 mg/5 mL intravenous bolus injection
554895|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554896|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554897|NCT00869609|E2|Reported Event|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554898|NCT00869609|E1|Reported Event|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.
GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
554899|NCT00869622|B3|Baseline|Total|Total of all reporting groups
554900|NCT00869622|B2|Baseline|Placebo Sugar Pill|Placebo participants received calcium and vitamin D supplementation in addition to a placebo tablet identical to risedronate tablet weekly
554901|NCT00869622|B1|Baseline|Risedronate|Active drug participants received calcium and vitamin D supplementation in addition to 35 mgs of risedronate tablet weekly
554902|NCT00869622|P2|Participant Flow|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D
Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
554903|NCT00869622|P1|Participant Flow|Risedronate|"Active drug
Risedronate: 35 mgs/week + calcium and vit d"
554904|NCT00869622|O2|Outcome|Placebo + Calcium and Vitamin D|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D
Placebo + Calcium and Vitamin D: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
554905|NCT00869622|O1|Outcome|Risedronate|"Active drug
Risedronate: 35 mgs/week + calcium and vit d"
554906|NCT00869622|O2|Outcome|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D
Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
554907|NCT00869622|O1|Outcome|Risedronate|"Active drug
Risedronate: 35 mgs/week + calcium and vit d"
554908|NCT00869622|E2|Reported Event|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D
Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
554909|NCT00869622|E1|Reported Event|Risedronate|"Active drug
Risedronate: 35 mgs/week + calcium and vit d"
554910|NCT00869778|B4|Baseline|Total|Total of all reporting groups
554911|NCT00869778|B3|Baseline|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
554912|NCT00869778|B2|Baseline|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
554913|NCT00869778|B1|Baseline|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28."
554914|NCT00869778|P3|Participant Flow|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
554915|NCT00869778|P2|Participant Flow|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
554916|NCT00869778|P1|Participant Flow|εPA-44 900μg|Subcutaneous injection of εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
554917|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
554918|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
554919|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
554920|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
554921|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
554922|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
554923|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
554924|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
556232|NCT00863707|O1|Outcome|Placebo|Matching intravenous (IV) bolus injection
554931|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
554932|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
554933|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
554934|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
554935|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
554936|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
554937|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
554938|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
554939|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
554940|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
554941|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
554942|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
554943|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
554944|NCT00869778|O3|Outcome|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
554945|NCT00869778|O2|Outcome|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
554946|NCT00869778|O1|Outcome|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28."
554947|NCT00869778|E3|Reported Event|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28."
554948|NCT00869778|E2|Reported Event|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28."
554949|NCT00869778|E1|Reported Event|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28."
554950|NCT00869791|B1|Baseline|All Study Participants|Participants who were randomized to receive either IPX066 or IR CD-LD
554951|NCT00869791|P2|Participant Flow|IR CD-LD First ( 7 Days), Washout (7 Days) Then IPX066 (7days)|In this arm there were 2 treatment periods of one week each. During period 1, 13 subjects received 7 days of IR CD-LD first. Then subjects returned to their pre-study regimen during the washout period of approximately 1 week. This was followed by Period 2. During period 2, the 13 subjects received IPX066 for 7 days.
554952|NCT00869791|P1|Participant Flow|IPX066 First (7 Days), Washout (7 Days) Then IR CD-LD (7 Days)|In this arm there were 2 treatment periods of one week each. During period 1, 14 subjects received 7 days of IPX066 first. Then subjects returned to their pre-study regimen during the washout period of approximately 1 week. This was followed by Period 2. During period 2, the 14 subjects received IR CD-LD for 7 days.
554953|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
554954|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
554955|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
554956|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
554957|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
554958|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
554959|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
554960|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
554961|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
554962|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
554963|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
554964|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
554965|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
554966|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
554967|NCT00869791|E2|Reported Event|CD-LD IR|All participants who received IR CD-LD in either study period
554968|NCT00869791|E1|Reported Event|IPX066|All participants who received IPX066 in either study period
554969|NCT00869947|B3|Baseline|Total|Total of all reporting groups
554970|NCT00869947|B2|Baseline|Non-amputee|Non-amputees
554971|NCT00869947|B1|Baseline|Prosthesis|Subjects with transtibial amputation using a passive ankle-foot prosthesis
554972|NCT00869947|P2|Participant Flow|Non-amputees|Non-amputees
554973|NCT00869947|P1|Participant Flow|Prosthesis|Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis
554974|NCT00869947|O3|Outcome|Non-Amputees|
554975|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
554976|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
554977|NCT00869947|O3|Outcome|Non-amputees|
554978|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
554979|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
554980|NCT00869947|O3|Outcome|Non-amputees|
554981|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
554982|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
554983|NCT00869947|E2|Reported Event|Non-amputees|Non-amputees
554984|NCT00869947|E1|Reported Event|Prosthesis|Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis
554985|NCT00869960|B1|Baseline|Combination Antiretroviral Therapy|Single dose administration of tenofovir, emtricitabine, atazanavir and ritonavir to healthy women
554986|NCT00869960|P1|Participant Flow|Antiretroviral Therapy|Healthy volunteers
554987|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
554988|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
554989|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
554990|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
554991|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
554992|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
554993|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
554994|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
554995|NCT00869960|E1|Reported Event|Antiretroviral Therapy|Healthy volunteers
554996|NCT00869999|B1|Baseline|Treatment Arm|All patients received treatment with everolimus-rituximab on this single am study
554997|NCT00869999|P1|Participant Flow|Everolimus-Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
554998|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
554999|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
555000|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
555001|NCT00869999|E1|Reported Event|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
555002|NCT00870103|B1|Baseline|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
555003|NCT00870103|P1|Participant Flow|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
555004|NCT00870103|O1|Outcome|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
555005|NCT00870103|O1|Outcome|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
555006|NCT00870103|E1|Reported Event|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
555007|NCT00870194|B3|Baseline|Total|Total of all reporting groups
555008|NCT00870194|B2|Baseline|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555009|NCT00870194|B1|Baseline|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555010|NCT00870194|P2|Participant Flow|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555011|NCT00870194|P1|Participant Flow|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555012|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555013|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555014|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555015|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555016|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555017|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555018|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555019|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555020|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555021|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555022|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555023|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555024|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555025|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555026|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555027|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555028|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555029|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555030|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555031|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555032|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555033|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555034|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555035|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555036|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555037|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555038|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555039|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555040|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555041|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555042|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555043|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555044|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555045|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555046|NCT00870194|E2|Reported Event|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
555047|NCT00870194|E1|Reported Event|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
555048|NCT00870363|B5|Baseline|Total|Total of all reporting groups
555049|NCT00870363|B4|Baseline|HIV Negative Controls Not on ART|HIV-negative
555050|NCT00870363|B3|Baseline|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555051|NCT00870363|B2|Baseline|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555052|NCT00870363|B1|Baseline|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555053|NCT00870363|P4|Participant Flow|HIV Negative Controls Not on ART|HIV-negative
555110|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555054|NCT00870363|P3|Participant Flow|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555055|NCT00870363|P2|Participant Flow|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555056|NCT00870363|P1|Participant Flow|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555057|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
555058|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555059|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555060|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555061|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
555062|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555063|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555064|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555065|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
555066|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555067|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555068|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555069|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
555070|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555180|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555071|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555072|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555073|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
555074|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555075|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555076|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555077|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
555078|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555079|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555080|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555081|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
555082|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555083|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555084|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555085|NCT00870363|E4|Reported Event|HIV Negative Controls Not on ART|HIV-negative
555086|NCT00870363|E3|Reported Event|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555087|NCT00870363|E2|Reported Event|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555646|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555088|NCT00870363|E1|Reported Event|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
555089|NCT00870467|B3|Baseline|Total|Total of all reporting groups
555090|NCT00870467|B2|Baseline|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555091|NCT00870467|B1|Baseline|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555092|NCT00870467|P6|Participant Flow|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555093|NCT00870467|P5|Participant Flow|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555094|NCT00870467|P4|Participant Flow|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555095|NCT00870467|P3|Participant Flow|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555096|NCT00870467|P2|Participant Flow|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555097|NCT00870467|P1|Participant Flow|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555098|NCT00870467|O1|Outcome|Any Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
555099|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555100|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555101|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555102|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555103|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555104|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555105|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555106|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555107|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555108|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555109|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555111|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555112|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555113|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555114|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555115|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555116|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555117|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555118|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555119|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555120|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555121|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
555122|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555123|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555124|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555125|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555126|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555127|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555128|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555129|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555130|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555131|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555132|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555133|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555647|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555134|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555135|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555136|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555137|NCT00870467|E3|Reported Event|Any Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
555138|NCT00870467|E2|Reported Event|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555139|NCT00870467|E1|Reported Event|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
555140|NCT00870545|B1|Baseline|Telephone Support|"12 telephone support groups based on the letters of the word BATTLEMIND
Telephone support groups : 12 hour-long structured telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND."
555141|NCT00870545|P1|Participant Flow|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
555142|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
555143|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
555144|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
555145|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
555146|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
555147|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
555148|NCT00870545|E1|Reported Event|Telephone Support|"12 telephone support groups based on the letters of the word BATTLEMIND
Telephone support groups : 12 hour-long structured telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND."
555149|NCT00870584|B3|Baseline|Total|Total of all reporting groups
555150|NCT00870584|B2|Baseline|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
555151|NCT00870584|B1|Baseline|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
555152|NCT00870584|P2|Participant Flow|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
555153|NCT00870584|P1|Participant Flow|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
555154|NCT00870584|O2|Outcome|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
555155|NCT00870584|O1|Outcome|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
555156|NCT00870584|O2|Outcome|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
555157|NCT00870584|O1|Outcome|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
555158|NCT00870584|E2|Reported Event|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
555159|NCT00870584|E1|Reported Event|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
555160|NCT00870688|B1|Baseline|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
555161|NCT00870688|P1|Participant Flow|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
555162|NCT00870688|O1|Outcome|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
555163|NCT00870740|B7|Baseline|Total|Total of all reporting groups
555164|NCT00870740|B6|Baseline|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555165|NCT00870740|B5|Baseline|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555166|NCT00870740|B4|Baseline|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555167|NCT00870740|B3|Baseline|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555168|NCT00870740|B2|Baseline|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555169|NCT00870740|B1|Baseline|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555170|NCT00870740|P6|Participant Flow|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555171|NCT00870740|P5|Participant Flow|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555172|NCT00870740|P4|Participant Flow|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555173|NCT00870740|P3|Participant Flow|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555174|NCT00870740|P2|Participant Flow|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555175|NCT00870740|P1|Participant Flow|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555176|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555177|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555178|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555179|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555181|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555182|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
555183|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
555184|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
555185|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555186|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555187|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555188|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555189|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555190|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555191|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555192|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555193|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555194|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555195|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555196|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555197|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555198|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555199|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555200|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555201|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555202|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555203|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555204|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555205|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555206|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555207|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555208|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555209|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555210|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555648|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555211|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555212|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555213|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555214|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555215|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
555216|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
555217|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
555218|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
555219|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
555220|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
555221|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555222|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555223|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555224|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555225|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555226|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555227|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
555228|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
555229|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
555230|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555231|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555232|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555233|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555234|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555235|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555236|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555237|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555238|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555239|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555240|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555241|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555242|NCT00870740|E6|Reported Event|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
555243|NCT00870740|E5|Reported Event|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
555244|NCT00870740|E4|Reported Event|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
555245|NCT00870740|E3|Reported Event|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
555246|NCT00870740|E2|Reported Event|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
555247|NCT00870740|E1|Reported Event|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
555248|NCT00870896|B1|Baseline|Tiotropium|Subjects 40-80 with > 10 pk/year or ex-smoker stopped within 1 year with 10 pk/year smoking history, Subjects with mild and moderate COPD defined by ATS/ERS clinically stable for 4 weeks, subjects off tiotropium or ipratropium 1 month prior to start, Chronic cough Defined by ATS/ERS Exclusion:Age < 40 or > 80, Refusal to volunteer, Lung disease other than COPD,O2 or ventilator dependent COPD, Received antibiotics or a change in inhaled steroid during last 4 weeks.History CHF, cardiomyopathy, valvular heart disease, angina, arrhythmia, MI or uncontrolled HTN within last 6 months, History chronic hepatitis/cirrhosis, End-stage renal disease, neurologic or psychiatric disorder, Physician diagnosis GERD/allergic/non-allergic rhinitis/sinusitis/lung cancer/radiation to the chest or mediastinum/Lung volume reduction surgery/lobectomy/pneumonectomy/thoracotomy, Symptomatic BPH/bladder outlet obstruction/glaucoma Severe COPD defined ERS/ATS, Allergic response or history of allergy to lactose
555249|NCT00870896|P1|Participant Flow|Group 1|Capsaicin Inhalation challenge (CIH): Each solution of capsaicin administered to a subject will be quantified by HPLC. Solutions of capsaicin are prepared to make a stock solution of 0.01 Mol and subsequently further diluted with physiologic saline solution to yield 11 serial doubling concentrations from 0.98 to 1,000 uMol/L. Final diluted capsaicin concentrations are: 0.98, 1.95, 3.9, 7.8, 15.6, 31.2, 62.5, 125, 250, 500, and 1000 uMol/L. Single breaths of capsaicin are delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until two or more coughs (C2) and five or more coughs (C5) are reached. The different concentrations are delivered at 2 minute intervals. CIH is administered at baseline one and 3 months following treatment with Spiriva
555250|NCT00870896|O1|Outcome|Change in FEV1/FVC|We measured the change in FEV1/FVC ratio before and after treatment with Spiriva. Change in ratio reflects the percentage value at 30 days minus the percentage value at baseline
555251|NCT00870896|O1|Outcome|Spirometry|We measured the change in FEV1 (in liters) at baseline and following 30 days of treatment with Spiriva.Spirometry will be performed with a KoKO Spirometer, which uses a pneumotachograph to provide Flow/Volume Loops and Volume/Time graphics and multiple incentive graphics for patient coaching. Spirometry will be performed at baseline and at 4 weeks. Normal values will be those of Hankinson, et al (Am J Respir Crit Care Med 159:179-187). Spirometry will also be performed after each dose of inhaled capsaicin. If there is a drop of 20% or more in FEV1 at any time after inhalation of capsaicin, the protocol will be ended at that point.
555252|NCT00870896|O1|Outcome|Group 1|Capsaicin Inhalation Challenge Testing (CICT) will follow the protocol of Dicpinigaitis et al (Chest 2003; 123:685-8). CICT will be performed at baseline before beginning treatment with tiotropium and at 4 weeks after initiation of treatment. Solutions of capsaicin are prepared to make a stock solution of 0.01 Mol and subsequently further diluted with physiologic saline solution to yield 11 serial doubling concentrations from 0.98 to 1,000 uMol/L. Final diluted capsaicin concentrations are: 0.98, 1.95, 3.9, 7.8, 15.6, 31.2, 62.5, 125, 250, 500, and 1000 uMol/L. Single breaths of capsaicin are delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until five or more coughs (C5) are reached. We measured the change in the number of coughs at baseline and following 30 days of treatment with spiriva
555253|NCT00870896|E1|Reported Event|Tiotropium|Subjects 40-80 with > 10 pk/year or ex-smoker stopped within 1 year with 10 pk/year smoking history, Subjects with mild and moderate COPD defined by ATS/ERS clinically stable for 4 weeks, subjects off tiotropium or ipratropium 1 month prior to start, Chronic cough Defined by ATS/ERS Exclusion:Age < 40 or > 80, Refusal to volunteer, Lung disease other than COPD,O2 or ventilator dependent COPD, Received antibiotics or a change in inhaled steroid during last 4 weeks.History CHF, cardiomyopathy, valvular heart disease, angina, arrhythmia, MI or uncontrolled HTN within last 6 months, History chronic hepatitis/cirrhosis, End-stage renal disease, neurologic or psychiatric disorder, Physician diagnosis GERD/allergic/non-allergic rhinitis/sinusitis/lung cancer/radiation to the chest or mediastinum/Lung volume reduction surgery/lobectomy/pneumonectomy/thoracotomy, Symptomatic BPH/bladder outlet obstruction/glaucoma Severe COPD defined ERS/ATS, Allergic response or history of allergy to lactose
555254|NCT00871000|B3|Baseline|Total|Total of all reporting groups
555255|NCT00871000|B2|Baseline|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555309|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555649|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555256|NCT00871000|B1|Baseline|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555257|NCT00871000|P2|Participant Flow|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555258|NCT00871000|P1|Participant Flow|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555259|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555260|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555261|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555262|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555263|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555264|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555265|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555266|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555267|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555310|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555650|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555268|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555269|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555270|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555271|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555272|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555273|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555274|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555275|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555276|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555277|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555278|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555279|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555311|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555521|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
555280|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555281|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555282|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555283|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555284|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555285|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555286|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555287|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555288|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555289|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555290|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555291|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555312|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555651|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555292|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555293|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555294|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555295|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555296|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555297|NCT00871000|E2|Reported Event|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555298|NCT00871000|E1|Reported Event|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
555299|NCT00871117|B3|Baseline|Total|Total of all reporting groups
555300|NCT00871117|B2|Baseline|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555301|NCT00871117|B1|Baseline|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555302|NCT00871117|P2|Participant Flow|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555303|NCT00871117|P1|Participant Flow|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555304|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555305|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555306|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555307|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555308|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555484|NCT00871377|P2|Participant Flow|P H L|Placebo, then High Dose, then Low Dose
555485|NCT00871377|P1|Participant Flow|P L H|Placebo, then Low Dose, then High Dose
555313|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555314|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555315|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555316|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555317|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555318|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555319|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555320|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555321|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555322|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555323|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555324|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555325|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555326|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555327|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555328|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555329|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
555330|NCT00871117|E2|Reported Event|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
555331|NCT00871117|E1|Reported Event|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm, and one dose of Varivax subcutaneously in the deltoid region of the right lower arm.
555332|NCT00871143|B3|Baseline|Total|Total of all reporting groups
555333|NCT00871143|B2|Baseline|Non Specific CBT|Anxiety Management treatment was provided once a week for 12 weeks, with each session lasting 1 hr. AM was planned to entail a therapeutic alliance, support and homework similar to the CBT group. The rationale provided was that when triggered, the person would experience a threat and negative thoughts about their appearance. This, in turn, would lead to physical symptoms of anxiety and magnify the perceived threat. The treatment consisted of (1) practising progressive muscle relaxation and breathing daily, (2) identifying triggers and physical symptoms associated with appearance-related anxiety and (3) utilising brief muscle relaxation and breathing techniques in trigger situations.
555486|NCT00871377|O3|Outcome|Fish OIl High Dose|Fish Oil - 6 capsules per day EPA+DHA = 2160 mg/day
555334|NCT00871143|B1|Baseline|CBT Specific for BDD|This consisted of 12 wks of 1 hr sessions (1 per week).The consisted of engagement in a developmental understanding of the problem and setting up an alternative view of the problem. Imagery rescripting followed for past aversive memories that were associated with the onset (e.g. bullying). The behaviours were aimed at either (1) threat detection and monitoring or (2) preventing feared consequences by avoidance or (3) attempts to undo the appearance concerns. The therapist aimed to help individuals identify their beliefs about processes, conduct behavioural experiments that tested out their expectations and to gradually drop the safety-seeking behaviours and test out their fears.
555335|NCT00871143|P2|Participant Flow|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits of anxiety management were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
555336|NCT00871143|P1|Participant Flow|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
555337|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
555338|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
555339|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
555340|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
555341|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
555342|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
555343|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
555344|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
555345|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
555346|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
555347|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
555348|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
555349|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
555350|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
555351|NCT00871143|E2|Reported Event|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
555352|NCT00871143|E1|Reported Event|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
555353|NCT00871169|B1|Baseline|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)
Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).
The treatment interval (one cycle) is every 14 days."
555354|NCT00871169|P1|Participant Flow|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)
Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).
The treatment interval (one cycle) is every 14 days."
555355|NCT00871169|O1|Outcome|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)
Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).
The treatment interval (one cycle) is every 14 days."
555356|NCT00871169|O1|Outcome|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)
Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).
The treatment interval (one cycle) is every 14 days."
555357|NCT00871169|E1|Reported Event|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)
Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).
The treatment interval (one cycle) is every 14 days."
555358|NCT00871234|B1|Baseline|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
555359|NCT00871234|P1|Participant Flow|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
555360|NCT00871234|O1|Outcome|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
555361|NCT00871234|E1|Reported Event|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
555362|NCT00871286|B3|Baseline|Total|Total of all reporting groups
555363|NCT00871286|B2|Baseline|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
555364|NCT00871286|B1|Baseline|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
555365|NCT00871286|P2|Participant Flow|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
555366|NCT00871286|P1|Participant Flow|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
555367|NCT00871286|O2|Outcome|CT Scan (Sinus) Post-tx|
555368|NCT00871286|O1|Outcome|CT Scan (Sinus) Pre-tx|
555369|NCT00871286|O2|Outcome|CT Scan (Sinus) Post-tx|
555370|NCT00871286|O1|Outcome|CT Scan (Sinus) Pre-tx|
555371|NCT00871286|E2|Reported Event|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
555487|NCT00871377|O2|Outcome|Fish Oil Low Dose|Fish Oil - 3 capsules per day Corn Oil - 3 capsules per day EPA+DHA = 1080 mg/day
555372|NCT00871286|E1|Reported Event|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
555373|NCT00871338|B3|Baseline|Total|Total of all reporting groups
555374|NCT00871338|B2|Baseline|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555375|NCT00871338|B1|Baseline|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555376|NCT00871338|P2|Participant Flow|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555377|NCT00871338|P1|Participant Flow|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555378|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555379|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555380|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555381|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555382|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555383|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555384|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555385|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555488|NCT00871377|O1|Outcome|Placebo|Corn Oil - 6 capsules per day
555489|NCT00871377|E3|Reported Event|Placebo|Corn Oil Placebo
555490|NCT00871377|E2|Reported Event|Low Dose|Low Dose Fish Oil Intervention
555491|NCT00871377|E1|Reported Event|High Dose|High Dose Fish Oil Intervention
555492|NCT00871403|B4|Baseline|Total|Total of all reporting groups
555386|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555387|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555388|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555389|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555390|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555391|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555392|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555393|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555394|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555395|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555396|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555397|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555398|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555511|NCT00871429|P1|Participant Flow|Lindi Skin Participant Flow|
555512|NCT00871429|O3|Outcome|Lindi Skin Face Serum (Product B)|
555513|NCT00871429|O2|Outcome|Lindi Skin Face Wash (Product C)|
555399|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555400|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555401|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555402|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555403|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555404|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555405|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555406|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555407|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555408|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555409|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555410|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555411|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555514|NCT00871429|O1|Outcome|Lindi Skin Soothing Balm (Product A)|
555515|NCT00871429|E3|Reported Event|Lindi Skin Face Serum (Product B)|
555516|NCT00871429|E2|Reported Event|Lindi Skin Face Wash (Product C)|
555517|NCT00871429|E1|Reported Event|Lindi Skin Soothing Balm (Product A)|
555412|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555413|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555414|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555415|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555416|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555417|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555418|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555419|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555420|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555421|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555422|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555423|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555424|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555518|NCT00871494|B1|Baseline|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
555425|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555426|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555427|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555428|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555429|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555430|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555431|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555432|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555433|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555434|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555435|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555436|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555437|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555519|NCT00871494|P1|Participant Flow|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
556233|NCT00863707|E2|Reported Event|Regadenoson|0.4 mg/5 mL intravenous bolus injection
555438|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555439|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555440|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555441|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555442|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555443|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555444|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555445|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555446|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555447|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555448|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555449|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555450|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555520|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
555451|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555452|NCT00871338|E2|Reported Event|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
555453|NCT00871338|E1|Reported Event|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
555454|NCT00871351|B4|Baseline|Total|Total of all reporting groups
555455|NCT00871351|B3|Baseline|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555456|NCT00871351|B2|Baseline|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555457|NCT00871351|B1|Baseline|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555458|NCT00871351|P3|Participant Flow|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555459|NCT00871351|P2|Participant Flow|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555460|NCT00871351|P1|Participant Flow|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555461|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555462|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555463|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555464|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555465|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555466|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555467|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555468|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555469|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555470|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555471|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555472|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555473|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555474|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555475|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555476|NCT00871351|E3|Reported Event|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555477|NCT00871351|E2|Reported Event|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555478|NCT00871351|E1|Reported Event|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
555479|NCT00871377|B1|Baseline|Baseline|The study began on Visit 1 when baseline data was collected and Intervention 1 was initiated.
555480|NCT00871377|P6|Participant Flow|H P L|High Dose, then Placebo, then Low Dose
555481|NCT00871377|P5|Participant Flow|H L P|High Dose, then Low Dose, then Placebo
555482|NCT00871377|P4|Participant Flow|L P H|Low Dose, then Placebo, then High Dose
555483|NCT00871377|P3|Participant Flow|L H P|Low Dose, then High Dose, then Placebo
560095|NCT00882687|E4|Reported Event|Placebo|
555493|NCT00871403|B3|Baseline|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
555494|NCT00871403|B2|Baseline|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
555495|NCT00871403|B1|Baseline|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
555496|NCT00871403|P3|Participant Flow|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
555497|NCT00871403|P2|Participant Flow|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
555498|NCT00871403|P1|Participant Flow|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
555499|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
555500|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
555501|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
555502|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
555503|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
555504|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
555505|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
555506|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
555507|NCT00871403|E3|Reported Event|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
555508|NCT00871403|E2|Reported Event|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
555509|NCT00871403|E1|Reported Event|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
555510|NCT00871429|B1|Baseline|Cancer Patients Using Lindi Skin Products|
555522|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
555523|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
555524|NCT00871494|E1|Reported Event|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
555525|NCT00871624|B3|Baseline|Total|Total of all reporting groups
555526|NCT00871624|B2|Baseline|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
555527|NCT00871624|B1|Baseline|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
555528|NCT00871624|P2|Participant Flow|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
555529|NCT00871624|P1|Participant Flow|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
555530|NCT00871624|O2|Outcome|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
555531|NCT00871624|O1|Outcome|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
555532|NCT00871624|E2|Reported Event|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
555533|NCT00871624|E1|Reported Event|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
555534|NCT00871689|B1|Baseline|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
555535|NCT00871689|P1|Participant Flow|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
555536|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
555537|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
555538|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
555539|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
555540|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
555541|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
555542|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
555652|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
560096|NCT00882687|E3|Reported Event|Lifitegrast 5.0%|
555543|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
555544|NCT00871689|E1|Reported Event|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
555545|NCT00871715|B4|Baseline|Total|Total of all reporting groups
555546|NCT00871715|B3|Baseline|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
555547|NCT00871715|B2|Baseline|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
555548|NCT00871715|B1|Baseline|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.
Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
555549|NCT00871715|P3|Participant Flow|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
555550|NCT00871715|P2|Participant Flow|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
555551|NCT00871715|P1|Participant Flow|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.
Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
555552|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
555553|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
555554|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.
Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
555590|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555653|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555555|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
555556|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
555557|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.
Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
555558|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
555559|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
555560|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.
Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
555561|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
555562|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
555563|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.
Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
555564|NCT00871715|E4|Reported Event|Screened But Not Randomized|Individuals who consented to an in-person screening assessment for eligibility but were never randomized.
555565|NCT00871715|E3|Reported Event|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
555566|NCT00871715|E2|Reported Event|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
555644|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555567|NCT00871715|E1|Reported Event|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.
Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
555568|NCT00871728|B1|Baseline|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
555569|NCT00871728|P1|Participant Flow|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
555570|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
555571|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
555572|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
555573|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
555574|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
555575|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
555576|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
555577|NCT00871728|E1|Reported Event|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
555578|NCT00871741|B3|Baseline|Total|Total of all reporting groups
555579|NCT00871741|B2|Baseline|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555580|NCT00871741|B1|Baseline|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555581|NCT00871741|P2|Participant Flow|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555582|NCT00871741|P1|Participant Flow|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555583|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555584|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555585|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555586|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555587|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555588|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555589|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555645|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555591|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555592|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555593|NCT00871741|E2|Reported Event|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555594|NCT00871741|E1|Reported Event|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
555595|NCT00871780|B1|Baseline|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555596|NCT00871780|P1|Participant Flow|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555597|NCT00871780|O3|Outcome|Natalizumab: Baseline EDSS >= 4.5|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS >= 4.5
555598|NCT00871780|O2|Outcome|Natalizumab: Baseline EDSS 3.0 to 4.0|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS 3.0 to 4.0
555599|NCT00871780|O1|Outcome|Natalizumab: Baseline EDSS 0 to 2.5|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS of 0 to 2.5
555600|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555601|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555602|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555603|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555604|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555605|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555606|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555607|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555608|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555609|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555610|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555611|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555612|NCT00871780|E1|Reported Event|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
555613|NCT00871819|B1|Baseline|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
555614|NCT00871819|P1|Participant Flow|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
555615|NCT00871819|O1|Outcome|All Subjects|All enrolled subjects
555616|NCT00871819|E1|Reported Event|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
555617|NCT00862251|B4|Baseline|Total|Total of all reporting groups
555618|NCT00862251|B3|Baseline|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555619|NCT00862251|B2|Baseline|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555620|NCT00862251|B1|Baseline|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555621|NCT00862251|P3|Participant Flow|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555622|NCT00862251|P2|Participant Flow|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555623|NCT00862251|P1|Participant Flow|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555624|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555625|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555626|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555627|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555628|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555629|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555630|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555631|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555632|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555633|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555634|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555635|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555636|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555637|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555638|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555639|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555640|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555641|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555642|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555643|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
560097|NCT00882687|E2|Reported Event|Lifitegrast 1.0%|
555655|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555656|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555657|NCT00862251|O2|Outcome|Doubling Atorvastatin Dose|atorvastatin 20 mg tablets, taken once daily for six weeks.
555658|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555659|NCT00862251|O2|Outcome|Doubling Simvastatin Dose|simvastatin 40 mg tablets, taken once daily for six weeks.
555660|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555661|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555662|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555663|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555664|NCT00862251|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555665|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555666|NCT00862251|O2|Outcome|Doubling Atorvastatin Dose|atorvastatin 20 mg tablets, taken once daily for six weeks.
555667|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555668|NCT00862251|O2|Outcome|Doubling Simvastatin Dose|simvastatin 40 mg tablets, taken once daily for six weeks.
555669|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555670|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555671|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555672|NCT00862251|E3|Reported Event|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
555673|NCT00862251|E2|Reported Event|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
555674|NCT00862251|E1|Reported Event|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
555675|NCT00862277|B4|Baseline|Total|Total of all reporting groups
555676|NCT00862277|B3|Baseline|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
555677|NCT00862277|B2|Baseline|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
555678|NCT00862277|B1|Baseline|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
555679|NCT00862277|P3|Participant Flow|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
555680|NCT00862277|P2|Participant Flow|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
555681|NCT00862277|P1|Participant Flow|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
555682|NCT00862277|O3|Outcome|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
555683|NCT00862277|O2|Outcome|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
555684|NCT00862277|O1|Outcome|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
555685|NCT00862277|O3|Outcome|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
555686|NCT00862277|O2|Outcome|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
555687|NCT00862277|O1|Outcome|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
555688|NCT00862277|E3|Reported Event|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
555689|NCT00862277|E2|Reported Event|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
555690|NCT00862277|E1|Reported Event|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
555691|NCT00862459|B4|Baseline|Total|Total of all reporting groups
555692|NCT00862459|B3|Baseline|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555693|NCT00862459|B2|Baseline|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555694|NCT00862459|B1|Baseline|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 millimole per kilogram of body weight (mmol/kg BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
555695|NCT00862459|P3|Participant Flow|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555722|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555696|NCT00862459|P2|Participant Flow|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555697|NCT00862459|P1|Participant Flow|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg body weight (BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
555698|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555699|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555700|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555701|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555702|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555703|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555704|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555705|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555706|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555707|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555708|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555709|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555710|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555711|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555712|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555713|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555714|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555715|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555716|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555717|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555718|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555719|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555720|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555721|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555723|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555724|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555725|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555726|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555727|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555728|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555729|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555730|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555731|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555732|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555733|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555734|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555735|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555736|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555737|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555738|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555739|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555740|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555741|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555742|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555743|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555744|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555745|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555746|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555747|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555748|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555749|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555750|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555751|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555752|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555753|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555754|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555755|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555756|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555757|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555758|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555759|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555760|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555761|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555762|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555763|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555764|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555765|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555766|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555767|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555768|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555769|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555770|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555771|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555772|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555773|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555774|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555775|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555776|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555777|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555778|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555779|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555780|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555781|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555782|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555783|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555784|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555785|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555786|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555787|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555788|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555789|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555790|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555791|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555792|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555793|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555794|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555795|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555796|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555797|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555798|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555799|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555800|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555801|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555802|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555803|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555804|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555805|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555806|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555807|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555808|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555809|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555810|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555811|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555812|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555813|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555814|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555815|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555816|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555817|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555818|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555819|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555820|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555821|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555822|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555823|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555824|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555825|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555826|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555827|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555828|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555829|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555830|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555831|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555832|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555833|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555834|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555835|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555836|NCT00862459|E4|Reported Event|Optimark~0.1mmol/kg BW|Reporting group 4 (RG4): Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555837|NCT00862459|E3|Reported Event|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Reporting group 3 (RG3): Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555838|NCT00862459|E2|Reported Event|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Reporting group 2 (RG2): Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555839|NCT00862459|E1|Reported Event|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Reporting Group 1 (RG1): Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
555840|NCT00862537|B1|Baseline|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
555841|NCT00862537|P1|Participant Flow|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
555842|NCT00862537|O1|Outcome|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
555843|NCT00862537|E1|Reported Event|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
555844|NCT00862563|B5|Baseline|Total|Total of all reporting groups
555845|NCT00862563|B4|Baseline|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
555846|NCT00862563|B3|Baseline|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
555847|NCT00862563|B2|Baseline|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
555848|NCT00862563|B1|Baseline|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
555849|NCT00862563|P4|Participant Flow|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
555850|NCT00862563|P3|Participant Flow|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
555851|NCT00862563|P2|Participant Flow|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
555852|NCT00862563|P1|Participant Flow|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
555853|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.
Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
555854|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .
Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
555855|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .
Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
555856|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.
zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
555857|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.
Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
555858|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .
topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
555885|NCT00862563|E4|Reported Event|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
555859|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .
Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
555860|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.
zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
555861|NCT00862563|O4|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
555862|NCT00862563|O3|Outcome|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
555863|NCT00862563|O2|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
555864|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
555865|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.
Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
555866|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .
topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
555867|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .
Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
555868|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.
zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
555869|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.
Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
555870|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .
topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
555871|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .
Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
555872|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.
zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
555873|NCT00862563|O4|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
555874|NCT00862563|O3|Outcome|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
555875|NCT00862563|O2|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
555876|NCT00862563|O1|Outcome|Zonisamide|Zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
555877|NCT00862563|O4|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
555878|NCT00862563|O3|Outcome|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
555879|NCT00862563|O2|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
555880|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
555881|NCT00862563|O4|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
555882|NCT00862563|O3|Outcome|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
555883|NCT00862563|O2|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
555884|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
555886|NCT00862563|E3|Reported Event|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
555887|NCT00862563|E2|Reported Event|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
555888|NCT00862563|E1|Reported Event|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
555889|NCT00862641|B5|Baseline|Total|Total of all reporting groups
555890|NCT00862641|B4|Baseline|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555891|NCT00862641|B3|Baseline|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555892|NCT00862641|B2|Baseline|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555893|NCT00862641|B1|Baseline|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
555894|NCT00862641|P4|Participant Flow|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555895|NCT00862641|P3|Participant Flow|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555896|NCT00862641|P2|Participant Flow|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555897|NCT00862641|P1|Participant Flow|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
555898|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555899|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555900|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555901|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
555902|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555903|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555904|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555905|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
555906|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555907|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555908|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555909|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
555910|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555911|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555912|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555913|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
555914|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555915|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555916|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555917|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
555918|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555919|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555920|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555921|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
555922|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555923|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555924|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555925|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
555926|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555927|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555928|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555929|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
555930|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555931|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555932|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555933|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
556225|NCT00863655|E1|Reported Event|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
555934|NCT00862641|E4|Reported Event|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555935|NCT00862641|E3|Reported Event|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
555936|NCT00862641|E2|Reported Event|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
555937|NCT00862641|E1|Reported Event|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
555938|NCT00862654|B5|Baseline|Total|Total of all reporting groups
555939|NCT00862654|B4|Baseline|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
555940|NCT00862654|B3|Baseline|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
555941|NCT00862654|B2|Baseline|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
555942|NCT00862654|B1|Baseline|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
555943|NCT00862654|P4|Participant Flow|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
555944|NCT00862654|P3|Participant Flow|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
555945|NCT00862654|P2|Participant Flow|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
555946|NCT00862654|P1|Participant Flow|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
555947|NCT00862654|O4|Outcome|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
555948|NCT00862654|O3|Outcome|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
555949|NCT00862654|O2|Outcome|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
555950|NCT00862654|O1|Outcome|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
555951|NCT00862654|E4|Reported Event|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
555952|NCT00862654|E3|Reported Event|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
555953|NCT00862654|E2|Reported Event|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
555954|NCT00862654|E1|Reported Event|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
555955|NCT00862719|B5|Baseline|Total|Total of all reporting groups
555956|NCT00862719|B4|Baseline|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
555957|NCT00862719|B3|Baseline|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
555958|NCT00862719|B2|Baseline|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
555959|NCT00862719|B1|Baseline|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
555960|NCT00862719|P4|Participant Flow|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
555961|NCT00862719|P3|Participant Flow|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
555962|NCT00862719|P2|Participant Flow|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
555963|NCT00862719|P1|Participant Flow|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
555964|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
555965|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
555966|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
555967|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
555968|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
555969|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
555970|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
555971|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
555972|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
555973|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
555974|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
555975|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
555976|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
555977|NCT00862719|E4|Reported Event|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
555978|NCT00862719|E3|Reported Event|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
555979|NCT00862719|E2|Reported Event|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
555980|NCT00862719|E1|Reported Event|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
555981|NCT00862745|B3|Baseline|Total|Total of all reporting groups
555982|NCT00862745|B2|Baseline|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
555983|NCT00862745|B1|Baseline|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
555984|NCT00862745|P2|Participant Flow|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
555985|NCT00862745|P1|Participant Flow|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
555986|NCT00862745|O2|Outcome|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
555987|NCT00862745|O1|Outcome|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
555988|NCT00862745|E2|Reported Event|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
555989|NCT00862745|E1|Reported Event|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
555990|NCT00862784|B1|Baseline|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
555991|NCT00862784|P1|Participant Flow|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
555992|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
555993|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
555994|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
555995|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
555996|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556226|NCT00863707|B3|Baseline|Total|Total of all reporting groups
555997|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
555998|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
555999|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556000|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556001|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556002|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556003|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556004|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556005|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556058|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556059|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556006|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556007|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556008|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556009|NCT00862784|E1|Reported Event|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:
Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.
This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
556010|NCT00862810|B3|Baseline|Total|Total of all reporting groups
556011|NCT00862810|B2|Baseline|Received Concomitant Vaccines First|Received concomitant vaccines first
556012|NCT00862810|B1|Baseline|Received HPV Vaccine First|Received HPV vaccine first
556013|NCT00862810|P2|Participant Flow|Received Concomitant Vaccines First|Received Concomitant Vaccines First
556014|NCT00862810|P1|Participant Flow|Received HPV Vaccine First|Received HPV vaccine first
556015|NCT00862810|O2|Outcome|Received Concomitant Vaccines First|Received concomitant vaccines first
556016|NCT00862810|O1|Outcome|Received HPV Vaccine First|Received HPV vaccine first
556017|NCT00862810|E2|Reported Event|Received Concomitant Vaccines First|Received concomitant vaccines first
556018|NCT00862810|E1|Reported Event|Received HPV Vaccine First|Received HPV vaccine first
556019|NCT00862823|B1|Baseline|Entire Study Population|Includes groups randomized to receive tablet first and liquid first
556020|NCT00862823|P2|Participant Flow|Liquid First, Then Tablet|Single dose of Atripla liquid in first intervention period and single dose of Atripla tablet in second intervnetion period
556021|NCT00862823|P1|Participant Flow|Tablet First, Then Liquid|Single dose of Atripla tablet in first intervention period and Single dose of Atripla liquid in second intervnetion period
556022|NCT00862823|O2|Outcome|Atripla Liquid|Includes groups randomized to receive tablet first and liquid first
556023|NCT00862823|O1|Outcome|Atripla Tablet|Includes groups randomized to receive tablet first and liquid first
556024|NCT00862823|O2|Outcome|Atripla Liquid|Includes groups randomized to receive tablet first and liquid first
556025|NCT00862823|O1|Outcome|Atripla Tablet|Includes groups randomized to receive tablet first and liquid first
556026|NCT00862823|E1|Reported Event|Entire Study Population|Includes groups randomized to receive tablet first and liquid first
556027|NCT00862836|B1|Baseline|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
556028|NCT00862836|P1|Participant Flow|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
556029|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
556030|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
556031|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
556032|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
556033|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
556034|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
556035|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
556036|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
556037|NCT00862836|E1|Reported Event|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
556060|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
556038|NCT00862849|B1|Baseline|All Participants|"All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C).
Intervention A: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Intervention B: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20
Intervention C: a single, SC injection of 0.15 U/kg insulin lispro alone
There was a washout period of 3 to 14 days between interventions.
The treatment sequence (ABC, ACB, BAC, BCA, CAB, or CBA) was repeated once so that each participant received up to 6 injections."
556039|NCT00862849|P6|Participant Flow|Lispro Alone First, Then RHI+rHuPH20, Then Lispro+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone
Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
556040|NCT00862849|P5|Participant Flow|Lispro Alone First, Then Lispro+rHuPH20, Then RHI+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
556041|NCT00862849|P4|Participant Flow|RHI+rHuPH20 First, Then Lispro Alone, Then Lispro+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
556042|NCT00862849|P3|Participant Flow|RHI+rHuPH20 First, Then Lispro+rHuPH20, Then Lispro Alone|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
556043|NCT00862849|P2|Participant Flow|Lispro+rHuPH20 First, Then Lispro Alone, Then RHI+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone
Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
556044|NCT00862849|P1|Participant Flow|Lispro+rHuPH20 First, Then RHI+rHuPH20, Then Lispro Alone|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
556045|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
556046|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556047|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556048|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
556049|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556050|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556051|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
556052|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556053|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556054|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
556055|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556056|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556057|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
556061|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556062|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556063|NCT00862849|E3|Reported Event|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
556064|NCT00862849|E2|Reported Event|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556065|NCT00862849|E1|Reported Event|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
556066|NCT00862940|B3|Baseline|Total|Total of all reporting groups
556067|NCT00862940|B2|Baseline|Placebo Tablets Twice Daily|
556068|NCT00862940|B1|Baseline|Memantine 10 mg Tablets Twice Daily|
556069|NCT00862940|P2|Participant Flow|Placebo Tablets Twice Daily|
556070|NCT00862940|P1|Participant Flow|Memantine 10 mg Tablets Twice Daily|
556071|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
556072|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
556073|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
556074|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
556075|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
556076|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
556077|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
556078|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
556079|NCT00862940|E2|Reported Event|Placebo Tablets Twice Daily|
556080|NCT00862940|E1|Reported Event|Memantine 10 mg Tablets Twice Daily|
556081|NCT00863057|B5|Baseline|Total|Total of all reporting groups
556082|NCT00863057|B4|Baseline|D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
556083|NCT00863057|B3|Baseline|D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
556084|NCT00863057|B2|Baseline|D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
556085|NCT00863057|B1|Baseline|D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
556086|NCT00863057|P4|Participant Flow|D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
556104|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556087|NCT00863057|P3|Participant Flow|D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
556088|NCT00863057|P2|Participant Flow|D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
556089|NCT00863057|P1|Participant Flow|D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
556090|NCT00863057|O2|Outcome|Duloxetine|Maximum tolerated daily dose of Duloxetine was reported.
556091|NCT00863057|O1|Outcome|Methadone|Maximum tolerated daily dose of Methadone was reported.
556092|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556093|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556094|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556095|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556096|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556097|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556098|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556099|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556100|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556101|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556102|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556103|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556105|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556106|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556107|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556108|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556109|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556110|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556111|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556112|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556113|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556114|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556115|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556116|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556117|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556118|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556119|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556120|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556121|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556122|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556123|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
556152|NCT00863330|O1|Outcome|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
556124|NCT00863057|E4|Reported Event|Duloxetine Placebo and Methadone Placebo|Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
556125|NCT00863057|E3|Reported Event|Duloxetine Placebo and Methadone|Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
556126|NCT00863057|E2|Reported Event|Duloxetine and Methadone Placebo|Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
556127|NCT00863057|E1|Reported Event|Duloxetine and Methadone|Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
556128|NCT00863109|B1|Baseline|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
556129|NCT00863109|P1|Participant Flow|PEG + RBV (Standard Clinical Practice)|Participants receive peginterferon alfa-2b (PEG) and ribavirin (RBV) in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
556130|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
556131|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
556132|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
556133|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
556134|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
556135|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
556136|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
556137|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
556138|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
556139|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
556140|NCT00863109|E1|Reported Event|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
556141|NCT00863317|B3|Baseline|Total|Total of all reporting groups
556142|NCT00863317|B2|Baseline|Sucrose|sucrose: table sugar as placebo daily for 14 days
556143|NCT00863317|B1|Baseline|Montelukast|"4mg granules
montelukast sodium: 4mg granules daily for 14 days"
556144|NCT00863317|P2|Participant Flow|Placebo|sucrose: table sugar as placebo daily for 14 days
556145|NCT00863317|P1|Participant Flow|Montelukast|"4mg granules
montelukast sodium: 4mg granules daily for 14 days"
556146|NCT00863317|O2|Outcome|Placebo|sucrose: table sugar as placebo daily for 14 days
556147|NCT00863317|O1|Outcome|Montelukast|"4mg granules
montelukast sodium: 4mg granules daily for 14 days"
556148|NCT00863317|E2|Reported Event|Placebo|sucrose: table sugar as placebo daily for 14 days
556149|NCT00863317|E1|Reported Event|Montelukast|"4mg granules
montelukast sodium: 4mg granules daily for 14 days"
556150|NCT00863330|B1|Baseline|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
556151|NCT00863330|P1|Participant Flow|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
556179|NCT00863512|B3|Baseline|Total|Total of all reporting groups
556180|NCT00863512|B2|Baseline|Arm II (Observation)|Patients receive standard care (observation).
556153|NCT00863330|E1|Reported Event|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
556154|NCT00863343|B3|Baseline|Total|Total of all reporting groups
556155|NCT00863343|B2|Baseline|Participants w/o Disease|Participants without Flu A by reference method
556156|NCT00863343|B1|Baseline|Participants w/ Disease|Positive for Flu A by reference test
556157|NCT00863343|P2|Participant Flow|Participants w/o Disease|Participants without Flu A by reference method
556158|NCT00863343|P1|Participant Flow|Participants w/ Disease|Positive for Flu A by reference test
556159|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu B by reference method
556160|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu B by reference test
556161|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu A by reference method
556162|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu A by reference test
556163|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu B by reference method
556164|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu B by reference test
556165|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu A by reference method
556166|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu A by reference test
556167|NCT00863343|E2|Reported Event|Participants w/o Disease|Participants without Flu by reference method
556168|NCT00863343|E1|Reported Event|Participants With Disease|Positive for Flu by reference test
556169|NCT00863356|B1|Baseline|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.
One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
556170|NCT00863356|P1|Participant Flow|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.
One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
556171|NCT00863356|O1|Outcome|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.
One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
556172|NCT00863356|E1|Reported Event|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.
One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
556173|NCT00863434|B1|Baseline|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.
clofarabine: Given IV
cytarabine: Given IV
filgrastim: Given SC"
556174|NCT00863434|P1|Participant Flow|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.
clofarabine: Given IV
cytarabine: Given IV
filgrastim: Given SC"
556175|NCT00863434|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.
clofarabine: Given IV
cytarabine: Given IV
filgrastim: Given SC"
556176|NCT00863434|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.
clofarabine: Given IV
cytarabine: Given IV
filgrastim: Given SC"
556177|NCT00863434|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.
clofarabine: Given IV
cytarabine: Given IV
filgrastim: Given SC"
556178|NCT00863434|E1|Reported Event|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.
clofarabine: Given IV
cytarabine: Given IV
filgrastim: Given SC"
556181|NCT00863512|B1|Baseline|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
556182|NCT00863512|P2|Participant Flow|Arm II (Observation)|Patients receive standard care (observation).
556183|NCT00863512|P1|Participant Flow|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
556184|NCT00863512|O2|Outcome|Arm II (Observation)|Patients receive standard care (observation).
556185|NCT00863512|O1|Outcome|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
556186|NCT00863512|E2|Reported Event|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
556187|NCT00863512|E1|Reported Event|Arm II (Observation)|Patients receive standard care (observation).
556188|NCT00863551|B1|Baseline|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
556189|NCT00863551|P1|Participant Flow|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
556190|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
556191|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
556192|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
556193|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
556194|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
556195|NCT00863551|E1|Reported Event|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
556196|NCT00863655|B3|Baseline|Total|Total of all reporting groups
556197|NCT00863655|B2|Baseline|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556198|NCT00863655|B1|Baseline|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556199|NCT00863655|P2|Participant Flow|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556200|NCT00863655|P1|Participant Flow|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556201|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556202|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556203|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556204|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556205|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556206|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556207|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556208|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556209|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556210|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556211|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556212|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556213|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556214|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556215|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556216|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556217|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556218|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556219|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556220|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556221|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556222|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556223|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
556224|NCT00863655|E2|Reported Event|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
556227|NCT00863707|B2|Baseline|Regadenoson|0.4 mg/5 mL intravenous bolus injection
556234|NCT00863707|E1|Reported Event|Placebo|Matching intravenous (IV) bolus injection
556235|NCT00863746|B3|Baseline|Total|Total of all reporting groups
556236|NCT00863746|B2|Baseline|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556237|NCT00863746|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556238|NCT00863746|P2|Participant Flow|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556239|NCT00863746|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556240|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556241|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556242|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556243|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556244|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556245|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556246|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556247|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556248|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556249|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556250|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556251|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556252|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556253|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556254|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556255|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556256|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556257|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556258|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556259|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
556260|NCT00863746|E2|Reported Event|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
556261|NCT00863746|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (BID)
556262|NCT00863798|B4|Baseline|Total|Total of all reporting groups
556263|NCT00863798|B3|Baseline|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556264|NCT00863798|B2|Baseline|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556265|NCT00863798|B1|Baseline|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556266|NCT00863798|P3|Participant Flow|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556267|NCT00863798|P2|Participant Flow|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556268|NCT00863798|P1|Participant Flow|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556269|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556270|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556271|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556272|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556273|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556274|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556275|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556276|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556277|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556278|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556279|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556280|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556281|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556282|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556283|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556284|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556285|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556286|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556287|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556288|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
557305|NCT00868140|O2|Outcome|2/Placebo|"Placebo control to arm 1
Placebo: placebo daily"
556289|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556290|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556291|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556292|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556293|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556294|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556295|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556296|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556297|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556298|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556299|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556300|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556301|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556302|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556303|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556304|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556305|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556306|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556307|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556308|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556309|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556310|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556311|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556312|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556313|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556314|NCT00863798|E3|Reported Event|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
556315|NCT00863798|E2|Reported Event|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
556316|NCT00863798|E1|Reported Event|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
556317|NCT00864032|B1|Baseline|Phase I|
556318|NCT00864032|P3|Participant Flow|Sorafenib 400/400|"Dose level 3 sorafenib 400 mg PO BID with concurrent neoadjuvant radiation therapy.
sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent."
556319|NCT00864032|P2|Participant Flow|Sorafenib 200/400|"Dose level 2 sorafenib 200 mg PO Q AM and 400 mg PO Q PM with concurrent neoadjuvant radiation therapy.
sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent.
Traditional 3+3 dose escalation Phase I trial. Cohort 2 enrolled after completion of all 3 participants in dose level 1."
556320|NCT00864032|P1|Participant Flow|Sorafenib 200/200|"Dose level 1 sorafenib 200 bid with concurrent neoadjuvant radiation therapy.
sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent."
556321|NCT00864032|O2|Outcome|Sorafenib 200/400|
556322|NCT00864032|O1|Outcome|Sorafenib 200/200|
556323|NCT00864032|E2|Reported Event|Sorafenib 200/400|Dose level 2. Sorafenib 200 mg PO Q AM and 400 mg PO Q PM
556324|NCT00864032|E1|Reported Event|Sorafenib 200/200|Dose level 1. Sorafenib 200 mg PO BID
556325|NCT00864084|B1|Baseline|Pulmonary Rehabilitation|People with respiratory disease
556326|NCT00864084|P1|Participant Flow|Pulmonary Rehabilitation|An 8-week out-patient pulmonary rehabilitation program.
556327|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
556328|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
556329|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
556330|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
556331|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
556332|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
556333|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
556362|NCT00864227|P1|Participant Flow|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556334|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
556335|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
556336|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
556337|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
556338|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
556339|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
556340|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
556341|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
556342|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
556343|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
556344|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
556345|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
556346|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
556347|NCT00864084|E1|Reported Event|Study Participation|Participant data collection at baseline (pre-pulmonary rehabilitation), participation in an 8-week outpatient pulmonary rehabilitation program and data collection at follow-up (post-pulmonary rehabilitation).
556348|NCT00864123|B3|Baseline|Total|Total of all reporting groups
556349|NCT00864123|B2|Baseline|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556350|NCT00864123|B1|Baseline|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556351|NCT00864123|P2|Participant Flow|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556352|NCT00864123|P1|Participant Flow|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556353|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556354|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556355|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556356|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556357|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556358|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556359|NCT00864123|E2|Reported Event|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556360|NCT00864123|E1|Reported Event|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
556361|NCT00864227|B1|Baseline|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
557314|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone
pioglitazone: pioglitazone 45 mg"
556363|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556364|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556365|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556366|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556367|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556368|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556369|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556370|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556371|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556372|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556373|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556374|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556375|NCT00864227|E1|Reported Event|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
556376|NCT00864253|B3|Baseline|Total|Total of all reporting groups
556377|NCT00864253|B2|Baseline|Dacarbazine Arm B 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556378|NCT00864253|B1|Baseline|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556379|NCT00864253|P2|Participant Flow|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556380|NCT00864253|P1|Participant Flow|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556381|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556382|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556383|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556384|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556385|NCT00864253|O2|Outcome|Dacarbazine Arm B|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556386|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556387|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556388|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556389|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556390|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556391|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556392|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556393|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556394|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556395|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556396|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556397|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556398|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556399|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556400|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556401|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556402|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556403|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556404|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556405|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
556406|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 every 4 weeks
556407|NCT00864253|E2|Reported Event|Dacarbazine Arm B|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
560098|NCT00882687|E1|Reported Event|Lifitegrast 0.1%|
556408|NCT00864253|E1|Reported Event|ABI-007 Arm A|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
556409|NCT00864383|B4|Baseline|Total|Total of all reporting groups
556410|NCT00864383|B3|Baseline|Regimen 3 - 2EMRZ/2MR (Ethambutol)|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556411|NCT00864383|B2|Baseline|Regimen 2 - 2MHRZ/2MHR (Isoniazid)|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556412|NCT00864383|B1|Baseline|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556413|NCT00864383|P3|Participant Flow|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556414|NCT00864383|P2|Participant Flow|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556415|NCT00864383|P1|Participant Flow|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556416|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556417|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556498|NCT00864708|P1|Participant Flow|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
556499|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
556500|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
556501|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
556502|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
556418|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556419|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556420|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556421|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556422|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556423|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556424|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556425|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556426|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556503|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
556427|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556428|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556429|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556430|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556431|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556432|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556433|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556434|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556435|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556504|NCT00864708|O1|Outcome|Arm 1|gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
556436|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556437|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556438|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556439|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556440|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556441|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556442|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556443|NCT00864383|E3|Reported Event|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556444|NCT00864383|E2|Reported Event|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556505|NCT00864708|E1|Reported Event|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
556445|NCT00864383|E1|Reported Event|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
Nine weeks of Isoniazid and Rifampicin only.
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
556446|NCT00864513|B1|Baseline|Chemotherapy|pemetrexed
556447|NCT00864513|P1|Participant Flow|Chemotherapy|Subjects will be treated with pemetrexed 500 mg/m2 IV once every 21 days. They are also premdicated with dexamethasone 4 mg po BID on the day before, of and after chemotherapy. They will start folic acid 350-1000mcg by mouth daily, 5-7 days before starting study therapy. They will also receive a 1000 mcg IM injeciton of vitamin B12 1-2 weeks before study drug, and eveyr 9 weeks thereafter, until 3 weeks after the last dose of study treatment
556448|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
556449|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
556450|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
556451|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
556452|NCT00864513|E1|Reported Event|Chemotherapy|pemetrexed
556453|NCT00864539|B7|Baseline|Total|Total of all reporting groups
556454|NCT00864539|B6|Baseline|Placebo|Subjects receiving daily placebo containing 1 g starch
556455|NCT00864539|B5|Baseline|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
556456|NCT00864539|B4|Baseline|Plain Juice|subjects receiving plain orange juice
556457|NCT00864539|B3|Baseline|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
556458|NCT00864539|B2|Baseline|Plain Milk|daily intake of 200 mL plain milk
556459|NCT00864539|B1|Baseline|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
556460|NCT00864539|P6|Participant Flow|Placebo|Subjects receiving daily placebo containing 1 g starch
556461|NCT00864539|P5|Participant Flow|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
556462|NCT00864539|P4|Participant Flow|Plain Juice|subjects receiving plain orange juice
556463|NCT00864539|P3|Participant Flow|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
556464|NCT00864539|P2|Participant Flow|Plain Milk|daily intake of 200 mL plain milk
556465|NCT00864539|P1|Participant Flow|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
556466|NCT00864539|O6|Outcome|Placebo|Subjects receiving daily placebo containing 1 g starch
556467|NCT00864539|O5|Outcome|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
556468|NCT00864539|O4|Outcome|Plain Juice|subjects receiving plain orange juice
556469|NCT00864539|O3|Outcome|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
556470|NCT00864539|O2|Outcome|Plain Milk|daily intake of 200 mL plain milk
556471|NCT00864539|O1|Outcome|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
556472|NCT00864539|E6|Reported Event|Placebo|Subjects receiving daily placebo containing 1 g starch
556473|NCT00864539|E5|Reported Event|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
556474|NCT00864539|E4|Reported Event|Plain Juice|subjects receiving plain orange juice
556475|NCT00864539|E3|Reported Event|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
556476|NCT00864539|E2|Reported Event|Plain Milk|daily intake of 200 mL plain milk
556477|NCT00864539|E1|Reported Event|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
556478|NCT00864682|B4|Baseline|Total|Total of all reporting groups
556479|NCT00864682|B3|Baseline|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
556480|NCT00864682|B2|Baseline|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
556481|NCT00864682|B1|Baseline|Control Arm|saline pretreatment, saline plus propofol admixture
556482|NCT00864682|P3|Participant Flow|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
556483|NCT00864682|P2|Participant Flow|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
556484|NCT00864682|P1|Participant Flow|Control Arm|saline pretreatment, saline plus propofol admixture
556485|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
556486|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
556487|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
556488|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
556489|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
556490|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
556491|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
556492|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
556493|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
556494|NCT00864682|E3|Reported Event|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
556495|NCT00864682|E2|Reported Event|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
556496|NCT00864682|E1|Reported Event|Control Arm|saline pretreatment, saline plus propofol admixture
556497|NCT00864708|B1|Baseline|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
556507|NCT00871871|B2|Baseline|All Part II Participants|Part II Overall: Isosorbide mononitrate (ISMN)in Period 1, followed by placebo in Period 2 or placebo in Period 1, followed by ISMN in Period 2
556508|NCT00871871|B1|Baseline|All Part I Participants|Part I Overall: Hydrochlorothiazide (HCTZ) in Period 1 followed by Placebo in Period 2 or Placebo in Period 1, followed by HCTZ in Period 2
556509|NCT00871871|P4|Participant Flow|ISMN Placebo First, Then ISMN|Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2
556510|NCT00871871|P3|Participant Flow|ISMN First, Then ISMN Placebo|Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2
556511|NCT00871871|P2|Participant Flow|HCTZ Placebo First, Then HCTZ|Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
556512|NCT00871871|P1|Participant Flow|HCTZ First, Then HCTZ Placebo|Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
556513|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
556514|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
556515|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
556516|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
556517|NCT00871871|O2|Outcome|Isosorbide Mononitrate (ISMN) Placebo|Part II: Participants on ISMN Placebo in either Period 1 or Period 2
556518|NCT00871871|O1|Outcome|Isosorbide Mononitrate (ISMN)|Part II: Participants on ISMN in either Period 1 or Period 2
556519|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
556520|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
556521|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
556522|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
556523|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
556524|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
556525|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
556526|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
556527|NCT00871871|E4|Reported Event|ISMN Placebo|Part II: Participants on ISMN Placebo in either Period 1 or Period 2
556528|NCT00871871|E3|Reported Event|ISMN|Part II: Participants on ISMN in either Period 1 or Period 2
556529|NCT00871871|E2|Reported Event|HCTZ Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
556530|NCT00871871|E1|Reported Event|HCTZ|Part I: Participants on HCTZ in either Period 1 or Period 2
556531|NCT00871975|B1|Baseline|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
556532|NCT00871975|P1|Participant Flow|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
556533|NCT00871975|O1|Outcome|Urodynamics + Tetra NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
556534|NCT00871975|E1|Reported Event|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
556535|NCT00872001|B3|Baseline|Total|Total of all reporting groups
556536|NCT00872001|B2|Baseline|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
556537|NCT00872001|B1|Baseline|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
556538|NCT00872001|P2|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
556539|NCT00872001|P1|Participant Flow|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
556540|NCT00872001|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
556541|NCT00872001|O1|Outcome|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
556542|NCT00872001|O2|Outcome|Placebo|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB.
556543|NCT00872001|O1|Outcome|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB).
556544|NCT00872001|E2|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
556545|NCT00872001|E1|Reported Event|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
556546|NCT00872027|B3|Baseline|Total|Total of all reporting groups
556547|NCT00872027|B2|Baseline|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.
Placebo: Placebo pills for 8 weeks"
556548|NCT00872027|B1|Baseline|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.
Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
556549|NCT00872027|P2|Participant Flow|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.
Placebo: Placebo pills for 8 weeks"
556550|NCT00872027|P1|Participant Flow|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.
Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
556551|NCT00872027|O2|Outcome|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.
Placebo: Placebo pills for 8 weeks"
556552|NCT00872027|O1|Outcome|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.
Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
556553|NCT00872027|E2|Reported Event|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.
Placebo: Placebo pills for 8 weeks"
556554|NCT00872027|E1|Reported Event|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.
Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
556555|NCT00872079|B1|Baseline|Genomics|"The specific aims of this research are:
Determine the structure and the type of neural network model for predictions from historically obtained data. (Computer Model)
Prospectively develop an individualized neural network and NONMEM model capable of predicting erythropoietin dosing for chronic in-center hemodialysis patients using adaptive techniques.
Develop computer programs based on neural computing that can be used in a clinical setting. (Computer Model)
Determine the utility of the computer programs prospectively in the clinical setting."
556556|NCT00872079|P1|Participant Flow|Genomics|Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.
556557|NCT00872079|O1|Outcome|Genomics|"Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.
There are 4 Aims in this study.
To collect historical data on warfarin dosing in subjects.
To collect genotype information on up to 300 subjects receiving warfarin anticoagulation.
to develop a computer model incorporating the information from aim 1 and aim 2.
To conduct a randomized clinical trial."
556558|NCT00872079|E1|Reported Event|Genomics|Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.
556559|NCT00872170|B3|Baseline|Total|Total of all reporting groups
556560|NCT00872170|B2|Baseline|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
556561|NCT00872170|B1|Baseline|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556562|NCT00872170|P2|Participant Flow|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
556563|NCT00872170|P1|Participant Flow|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556564|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556565|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556566|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556567|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556568|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556569|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556570|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556571|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556572|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556573|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556574|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556575|NCT00872170|E2|Reported Event|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
556576|NCT00872170|E1|Reported Event|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
556577|NCT00872339|B4|Baseline|Total|Total of all reporting groups
556578|NCT00872339|B3|Baseline|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
556579|NCT00872339|B2|Baseline|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
556580|NCT00872339|B1|Baseline|Transfusion-dependant|People with transfusion-dependant thalassemia.
556581|NCT00872339|P3|Participant Flow|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
556582|NCT00872339|P2|Participant Flow|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
556583|NCT00872339|P1|Participant Flow|Transfusion-dependant|People with transfusion-dependant thalassemia.
556584|NCT00872339|O1|Outcome|All Subjects Combined|Subjects with pain in the last 7 days were combined into one group.
556585|NCT00872339|O1|Outcome|All Subjects Combined|Subjects were combined into one group.
556586|NCT00872339|O1|Outcome|All Subjects Combined|Subjects with pain in the last 7 days were combined into one group.
556587|NCT00872339|O3|Outcome|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
562526|NCT00881335|O2|Outcome|Control Group|without any intervention
556588|NCT00872339|O2|Outcome|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
556589|NCT00872339|O1|Outcome|Transfusion-dependant|People with transfusion-dependant thalassemia.
556590|NCT00872339|E1|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected for this study.
556591|NCT00872430|B3|Baseline|Total|Total of all reporting groups
556592|NCT00872430|B2|Baseline|Laxative Tea First Crossover|Laxative tea in the first period and placebo in the second period (after washout period).
556593|NCT00872430|B1|Baseline|Placebo First Crossover|Placebo in the first period and laxative tea in the second period (after washout period)
556594|NCT00872430|P2|Participant Flow|Laxative Tea First Crossover|Laxative tea in the first period and placebo in the second period (after washout period).
556595|NCT00872430|P1|Participant Flow|Placebo First Crossover|Placebo in the first period and laxative tea in the second period (after washout period)
556596|NCT00872430|O2|Outcome|Laxative Tea|Laxative tea administered three times a day in either first intervention period or second intervention period.
556597|NCT00872430|O1|Outcome|Placebo|Placebo administered three times a day in either first intervention period or second intervention period.
556598|NCT00872430|O2|Outcome|Laxative Tea|Laxative tea administered three times a day in either first intervention period or second intervention period.
556599|NCT00872430|O1|Outcome|Placebo|Placebo administered three times a day in either first intervention period or second intervention period.
556600|NCT00872521|B4|Baseline|Total|Total of all reporting groups
556601|NCT00872521|B3|Baseline|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556602|NCT00872521|B2|Baseline|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556603|NCT00872521|B1|Baseline|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556604|NCT00872521|P3|Participant Flow|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556605|NCT00872521|P2|Participant Flow|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556606|NCT00872521|P1|Participant Flow|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556607|NCT00872521|O2|Outcome|Positive|Participants with FGFR3 expression
556608|NCT00872521|O1|Outcome|Negative|Participants without FGFR3 expression
556609|NCT00872521|O2|Outcome|Positive|Participants with bcl-2 expression
556610|NCT00872521|O1|Outcome|Negative|Participants without bcl-2 expression
556611|NCT00872521|O2|Outcome|Positive|Participants with Cyclin D1 expression
556612|NCT00872521|O1|Outcome|Negative|Participants without Cyclin D1 expression
556613|NCT00872521|O2|Outcome|Positive|Participants with p53 expression
556614|NCT00872521|O1|Outcome|Negative|Participants without p53 expression
556615|NCT00872521|O2|Outcome|Positive|Participants with FGFR3 expression
556616|NCT00872521|O1|Outcome|Negative|Participants without FGFR3 expression
556617|NCT00872521|O2|Outcome|Positive|Participants with bcl-2 expression
556618|NCT00872521|O1|Outcome|Negative|Participants without bcl-2 expression
556619|NCT00872521|O2|Outcome|Positive|Participants with Cyclin D1 expression
556620|NCT00872521|O1|Outcome|Negative|Participants without Cyclin D1 expression
556621|NCT00872521|O2|Outcome|Positive|Participants with p53 expression
556622|NCT00872521|O1|Outcome|Negative|Participants without p53 expression
556623|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556624|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556625|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556626|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556627|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556628|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556629|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556706|NCT00872833|O2|Outcome|Older Cohort|People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
556630|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556631|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556632|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556633|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556634|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556635|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556636|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556637|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556638|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556639|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556640|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556641|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556642|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556643|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556644|NCT00872521|O3|Outcome|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556645|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556646|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556647|NCT00872521|E4|Reported Event|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556648|NCT00872521|E3|Reported Event|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556649|NCT00872521|E2|Reported Event|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556650|NCT00872521|E1|Reported Event|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
556651|NCT00872534|B3|Baseline|Total|Total of all reporting groups
556652|NCT00872534|B2|Baseline|Aspirin|"Immediate release 325mg aspirin
acetylsalicylic acid: 325mg once a day for 7 days"
556653|NCT00872534|B1|Baseline|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
acetylsalicylic acid: 325mg once a day for 7 days"
556654|NCT00872534|P2|Participant Flow|Aspirin|"Immediate release 325mg aspirin
acetylsalicylic acid: 325mg once a day for 7 days"
556655|NCT00872534|P1|Participant Flow|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
acetylsalicylic acid: 325mg once a day for 7 days"
556656|NCT00872534|O2|Outcome|Aspirin|"Immediate release 325mg aspirin
acetylsalicylic acid: 325mg once a day for 7 days"
556657|NCT00872534|O1|Outcome|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
acetylsalicylic acid: 325mg once a day for 7 days"
556658|NCT00872534|E2|Reported Event|Aspirin|"Immediate release 325mg aspirin
acetylsalicylic acid: 325mg once a day for 7 days"
557306|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone treated subjects
pioglitazone: pioglitazone 45 mg"
556659|NCT00872534|E1|Reported Event|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
acetylsalicylic acid: 325mg once a day for 7 days"
556660|NCT00872599|B1|Baseline|Study Group|
556661|NCT00872599|P2|Participant Flow|Fenofibrate, Then Placebo|Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received fenofibrate 160mg/d. During the second they received matching placebo.
556662|NCT00872599|P1|Participant Flow|Placebo, Then Fenofibrate|Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received matching placebo. During the second they received fenofibrate 160mg/d.
556663|NCT00872599|O2|Outcome|Salt-sensitive Hypertension|Subjects were classified as salt-sensitive if the average study day mean arterial pressure was at least 5 mmHg higher during high salt placebo compared to low salt intake
556664|NCT00872599|O1|Outcome|Salt-resistant Hypertension|Subjects whose average study day mean arterial pressure was less than 5 mmHg higher during high salt intake compared to low salt intake
556665|NCT00872599|O2|Outcome|Salt-sensitive Hypertension|Subjects were classified as salt-sensitive if the average study day mean arterial pressure was at least 5 mmHg higher during high salt placebo compared to low salt intake
556666|NCT00872599|O1|Outcome|Salt-resistant Hypertension|Subjects whose average study day mean arterial pressure was less than 5 mmHg higher during high salt intake compared to low salt intake
556667|NCT00872599|E2|Reported Event|Fenofibrate|
556668|NCT00872599|E1|Reported Event|Placebo|
556669|NCT00872729|B1|Baseline|Cystagon® and RP103|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules,150 mg/50 mg; Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules,75 mg.
556670|NCT00872729|P1|Participant Flow|Cystagon® and RP103|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules,150 mg/50 mg; Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules,75 mg; Single-dose, open-label, nonrandomized, 2-period, crossover study of cysteamine bitartrate delayed-release capsules (RP103) and Cystagon®. Subjects were enrolled sequentially and received Cystagon® first followed by RP103.
556671|NCT00872729|O20|Outcome|RP103 (12 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556672|NCT00872729|O19|Outcome|Cystagon® (12 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556673|NCT00872729|O18|Outcome|RP103 (10 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556674|NCT00872729|O17|Outcome|Cystagon® (10 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556675|NCT00872729|O16|Outcome|RP103 (8 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556676|NCT00872729|O15|Outcome|Cystagon® (8 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556677|NCT00872729|O14|Outcome|RP103 (6 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556678|NCT00872729|O13|Outcome|Cystagon® (6 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556679|NCT00872729|O12|Outcome|RP103 (4 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556680|NCT00872729|O11|Outcome|Cystagon® (4 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556681|NCT00872729|O10|Outcome|RP103 (3 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556682|NCT00872729|O9|Outcome|Cystagon® (3 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556683|NCT00872729|O8|Outcome|RP103 (2.5 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556684|NCT00872729|O7|Outcome|Cystagon® (2.5 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556685|NCT00872729|O6|Outcome|RP103 (2 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556686|NCT00872729|O5|Outcome|Cystagon® (2 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556687|NCT00872729|O4|Outcome|RP103 (1 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556688|NCT00872729|O3|Outcome|Cystagon® (1 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556689|NCT00872729|O2|Outcome|RP103 (0.5 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556690|NCT00872729|O1|Outcome|Cystagon® (0.5 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556691|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556692|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556693|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556694|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556695|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
556696|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
556697|NCT00872729|E2|Reported Event|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg
556698|NCT00872729|E1|Reported Event|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg;
556699|NCT00872833|B1|Baseline|Overall|Both cohorts combined
556700|NCT00872833|P2|Participant Flow|Older Cohort|People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
556701|NCT00872833|P1|Participant Flow|Younger Cohort|People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
556702|NCT00872833|O4|Outcome|> 28 Days|Subjects with transfusion cycles greater than 28 days
556703|NCT00872833|O3|Outcome|22 - 28 Days|Subjects with transfusion cycles between 22 and 28 days
556704|NCT00872833|O2|Outcome|15 - 21 Days|Subjects with transfusion cycles between 15 and 21 days
556705|NCT00872833|O1|Outcome|<= 14 Days|Subjects with transfusion cycles of 14 days or less
557307|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1
Placebo: placebo daily"
556707|NCT00872833|O1|Outcome|Younger Cohort|People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
556708|NCT00872833|E1|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected as part of this observational study.
556709|NCT00872898|B4|Baseline|Total|Total of all reporting groups
556710|NCT00872898|B3|Baseline|Part Two - Memantine|Once daily oral administration of memantine extended release for 12 weeks. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups.
556711|NCT00872898|B2|Baseline|Part Two - Placebo|Once daily oral administration of placebo for 12 weeks.
556712|NCT00872898|B1|Baseline|Part One - Memantine|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
556713|NCT00872898|P2|Participant Flow|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556714|NCT00872898|P1|Participant Flow|Placebo|Once daily, oral administration of placebo for 12 weeks.
556715|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556716|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556717|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556718|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556719|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556720|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556721|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556722|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556723|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556724|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556725|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556726|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556727|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556728|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556729|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556730|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556731|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556732|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556733|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556734|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556735|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556736|NCT00872898|O1|Outcome|Placebo|Once daily, oral administration of placebo for 12 weeks.
556737|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556738|NCT00872898|O1|Outcome|Placebo|Once daily, oral administration of placebo for 12 weeks.
556739|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556740|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556741|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
556742|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
556743|NCT00872898|O1|Outcome|Memantine|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
556744|NCT00872898|E3|Reported Event|Memantine - Part One, Open Label Treatment|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
556745|NCT00872898|E2|Reported Event|Memantine - Part Two, Double-Blind Treatment|"Once daily oral administration of memantine extended release for 12 weeks.
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups."
556746|NCT00872898|E1|Reported Event|Placebo - Part Two, Double-Blind Treatment|Once daily oral administration of placebo for 12 weeks
556747|NCT00872989|B3|Baseline|Total|Total of all reporting groups
556748|NCT00872989|B2|Baseline|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
vandetanib: Given orally"
556989|NCT00873860|B4|Baseline|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
556749|NCT00872989|B1|Baseline|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.
docetaxel: Given IV
vandetanib: Given orally"
556750|NCT00872989|P2|Participant Flow|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
vandetanib: Given orally"
556751|NCT00872989|P1|Participant Flow|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.
docetaxel: Given IV
vandetanib: Given orally"
556752|NCT00872989|O1|Outcome|Vandetanib|Patients elected to participant in the crossover registration in Vandetanib after progression in single agent docetaxel.
556753|NCT00872989|O1|Outcome|Vandetanib|Vandetanib treated patients
556754|NCT00872989|O3|Outcome|Vandetanib|
556755|NCT00872989|O2|Outcome|Docetaxel + Vandetanib|
556756|NCT00872989|O1|Outcome|Docetaxel|
556757|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
vandetanib: Given orally"
556758|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.
docetaxel: Given IV
vandetanib: Given orally"
556759|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
vandetanib: Given orally"
556760|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.
docetaxel: Given IV
vandetanib: Given orally"
556761|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
vandetanib: Given orally"
556762|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.
docetaxel: Given IV
vandetanib: Given orally"
556763|NCT00872989|E3|Reported Event|Vandetanib|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
556764|NCT00872989|E2|Reported Event|Docetaxel + Vandetanib|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
556765|NCT00872989|E1|Reported Event|Docetaxel|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
556766|NCT00873015|B5|Baseline|Total|Total of all reporting groups
556767|NCT00873015|B4|Baseline|64 Nmol/Min/kg|Sodium nitrite: 14 day continuous infusion 64 nmol/min/kg
556768|NCT00873015|B3|Baseline|48 Nmol/Min/kg|Sodium nitrite: 14 day continuous infusion 48 nmol/min/kg
556769|NCT00873015|B2|Baseline|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
556770|NCT00873015|B1|Baseline|32 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion 32 nmol/min/kg
556771|NCT00873015|P4|Participant Flow|Nitrite 64 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 64 nmol/min/kg
556772|NCT00873015|P3|Participant Flow|Nitrite 48 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 48 nmol/min/kg
556773|NCT00873015|P2|Participant Flow|Nitrite 32 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 32 nmol/min/kg
556774|NCT00873015|P1|Participant Flow|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
556775|NCT00873015|O3|Outcome|32 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 32 nmol/min/kg
556776|NCT00873015|O2|Outcome|48 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 48 nmol/min/kg
556777|NCT00873015|O1|Outcome|64 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 64 nmol/min/kg
556778|NCT00873015|E2|Reported Event|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
556779|NCT00873015|E1|Reported Event|Nitrite|Sodium nitrite : 14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg
556780|NCT00873041|B4|Baseline|Total|Total of all reporting groups
556781|NCT00873041|B3|Baseline|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556782|NCT00873041|B2|Baseline|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556783|NCT00873041|B1|Baseline|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556784|NCT00873041|P3|Participant Flow|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556785|NCT00873041|P2|Participant Flow|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556786|NCT00873041|P1|Participant Flow|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556787|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556788|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556789|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556790|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556791|NCT00873041|O1|Outcome|All Randomized Participants|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets or matching placebo orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556792|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556793|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556794|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556795|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556796|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556797|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556798|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556799|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556800|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556801|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556802|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556803|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556804|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556805|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556806|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556807|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556808|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556809|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556810|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556811|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556812|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556813|NCT00873041|O1|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556814|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556815|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556816|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556817|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556818|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556819|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556820|NCT00873041|O1|Outcome|All Randomized Participants|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets or matching placebo orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556821|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556822|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556990|NCT00873860|B3|Baseline|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557308|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone
pioglitazone: pioglitazone 45 mg"
556823|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556824|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556825|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556826|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556827|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556828|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556829|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556830|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556831|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556832|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556833|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556834|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556835|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
556836|NCT00873041|E3|Reported Event|Placebo/Deferasirox Any Dose|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556837|NCT00873041|E2|Reported Event|Deferasirox 10 mg/kg/Day|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556838|NCT00873041|E1|Reported Event|Deferasirox 5 mg/kg/Day|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
556839|NCT00873093|B6|Baseline|Total|Total of all reporting groups
556840|NCT00873093|B5|Baseline|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556841|NCT00873093|B4|Baseline|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556842|NCT00873093|B3|Baseline|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556991|NCT00873860|B2|Baseline|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557309|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1
Placebo: placebo daily"
556843|NCT00873093|B2|Baseline|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556844|NCT00873093|B1|Baseline|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556845|NCT00873093|P5|Participant Flow|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556846|NCT00873093|P4|Participant Flow|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556847|NCT00873093|P3|Participant Flow|Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556848|NCT00873093|P2|Participant Flow|Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556849|NCT00873093|P1|Participant Flow|Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556850|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556851|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556852|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556853|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556992|NCT00873860|B1|Baseline|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
556993|NCT00873860|P4|Participant Flow|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
563301|NCT00890682|O1|Outcome|SKY0402|Single injection of study drug
556854|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556855|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556856|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556857|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556858|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556859|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556860|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556882|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556994|NCT00873860|P3|Participant Flow|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557310|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone
pioglitazone: pioglitazone 45 mg"
556861|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556862|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556863|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556864|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556865|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556866|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556867|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556883|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556995|NCT00873860|P2|Participant Flow|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557311|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1
Placebo: placebo daily"
556868|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556869|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9
doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22
vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9
prednisone: Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8
pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22
MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22
etopo"
556870|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556871|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556872|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556873|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556874|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556875|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556876|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556877|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556878|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556879|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556880|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556881|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556970|NCT00873730|E1|Reported Event|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556884|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556885|NCT00873093|O1|Outcome|Overall|All enrolled eligible patients.
556886|NCT00873093|O1|Outcome|Overall|All enrolled eligible patients.
556887|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556888|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556889|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556890|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556891|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556892|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556893|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556894|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556895|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556896|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556897|NCT00873093|E5|Reported Event|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556898|NCT00873093|E4|Reported Event|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556899|NCT00873093|E3|Reported Event|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556900|NCT00873093|E2|Reported Event|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556996|NCT00873860|P1|Participant Flow|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
556997|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557312|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone
pioglitazone: pioglitazone 45 mg"
556901|NCT00873093|E1|Reported Event|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
556902|NCT00873119|B3|Baseline|Total|Total of all reporting groups
556903|NCT00873119|B2|Baseline|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
556904|NCT00873119|B1|Baseline|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
556905|NCT00873119|P2|Participant Flow|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
556906|NCT00873119|P1|Participant Flow|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
556907|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
556908|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
556909|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
556910|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
556911|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
556912|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
556913|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
556914|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
556915|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
556916|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
556917|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
556918|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
556919|NCT00873119|E2|Reported Event|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
556987|NCT00873821|E1|Reported Event|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
556920|NCT00873119|E1|Reported Event|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
556921|NCT00873327|B1|Baseline|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses
piperacillin-tazobactam : 6 doses intravenously at the following doses:
Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6
Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6
≥ 14 days PNA 100 mg/kg Q6"
556922|NCT00873327|P1|Participant Flow|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses
piperacillin-tazobactam : 6 doses intravenously at the following doses:
Infants <32 weeks gestation at birth < 14 days postnatal age (PNA) 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6
Infants ≥32 weeks gestation (GA) at birth < 14 days PNA 100 mg/kg Q6
≥ 14 days PNA 100 mg/kg Q6"
556923|NCT00873327|O1|Outcome|PK Analysis Cohort - Piperacillin Plasma Clearance|"Open label -- 6 interval doses
piperacillin-tazobactam : 6 doses intravenously at the following doses:
Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6
Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6
≥ 14 days PNA 100 mg/kg Q6"
556924|NCT00873327|E1|Reported Event|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses
piperacillin-tazobactam : 6 doses intravenously at the following doses:
Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6
Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6
≥ 14 days PNA 100 mg/kg Q6"
556925|NCT00873457|B1|Baseline|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
556926|NCT00873457|P1|Participant Flow|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
556927|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
556928|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
556929|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
556930|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
556931|NCT00873457|E1|Reported Event|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
556932|NCT00873730|B3|Baseline|Total|Total of all reporting groups
556933|NCT00873730|B2|Baseline|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556934|NCT00873730|B1|Baseline|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556935|NCT00873730|P2|Participant Flow|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556936|NCT00873730|P1|Participant Flow|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556937|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556938|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556939|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556940|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556941|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556942|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556943|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556944|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556945|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556946|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556947|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556948|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556949|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556950|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556951|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556952|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556953|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556954|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556955|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556956|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556957|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556958|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556959|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556960|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556961|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556962|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556963|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556964|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556965|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556966|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556967|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556968|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
556969|NCT00873730|E2|Reported Event|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
556971|NCT00873782|B1|Baseline|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
556972|NCT00873782|P1|Participant Flow|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
556973|NCT00873782|O1|Outcome|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
556974|NCT00873782|E1|Reported Event|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
556975|NCT00873821|B3|Baseline|Total|Total of all reporting groups
556976|NCT00873821|B2|Baseline|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
556977|NCT00873821|B1|Baseline|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
556978|NCT00873821|P2|Participant Flow|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
556979|NCT00873821|P1|Participant Flow|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
556980|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
556981|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
556982|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
556983|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
556984|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
556985|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
556986|NCT00873821|E2|Reported Event|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
556988|NCT00873860|B5|Baseline|Total|Total of all reporting groups
557140|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
556998|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
556999|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557000|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557001|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557002|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557003|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557004|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557005|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557006|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557007|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557008|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557009|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557010|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557011|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557012|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557013|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557014|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557015|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557016|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557017|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557018|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557019|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557020|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557021|NCT00873860|O3|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557022|NCT00873860|O2|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557023|NCT00873860|O1|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557024|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557025|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557026|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557027|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557028|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557029|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557030|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557031|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557032|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557033|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557034|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557035|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557036|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557037|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557038|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557039|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557040|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557041|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557042|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557043|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557141|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
557044|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557045|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557046|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557047|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557048|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557049|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557050|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557051|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557052|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557053|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557054|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557055|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557056|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557057|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557058|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557059|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557060|NCT00873860|E4|Reported Event|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557061|NCT00873860|E3|Reported Event|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557062|NCT00873860|E2|Reported Event|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557063|NCT00873860|E1|Reported Event|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
557064|NCT00873873|B5|Baseline|Total|Total of all reporting groups
557065|NCT00873873|B4|Baseline|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
557066|NCT00873873|B3|Baseline|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
557067|NCT00873873|B2|Baseline|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
557068|NCT00873873|B1|Baseline|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
557069|NCT00873873|P4|Participant Flow|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
557070|NCT00873873|P3|Participant Flow|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
557071|NCT00873873|P2|Participant Flow|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
557072|NCT00873873|P1|Participant Flow|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
557073|NCT00873873|O4|Outcome|Persistent Normal|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
557074|NCT00873873|O3|Outcome|Late Normal|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
557075|NCT00873873|O2|Outcome|Late Obstruction|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
557076|NCT00873873|O1|Outcome|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
557077|NCT00873873|O4|Outcome|Persistent Normal|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
557078|NCT00873873|O3|Outcome|Late Normal|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
557079|NCT00873873|O2|Outcome|Late Obstruction|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
557080|NCT00873873|O1|Outcome|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
557142|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
557081|NCT00873873|E4|Reported Event|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
557082|NCT00873873|E3|Reported Event|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
557083|NCT00873873|E2|Reported Event|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
557084|NCT00873873|E1|Reported Event|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
557085|NCT00873912|B3|Baseline|Total|Total of all reporting groups
557086|NCT00873912|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
557087|NCT00873912|B1|Baseline|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
557088|NCT00873912|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
557089|NCT00873912|P1|Participant Flow|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
557090|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
557091|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
557092|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
557093|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
557094|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
557095|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
557096|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
557097|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
557098|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
557099|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
557100|NCT00873912|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
557101|NCT00873912|E1|Reported Event|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
557143|NCT00874250|E1|Reported Event|CTAG Device Aneurysm Subjects|
557144|NCT00874276|B3|Baseline|Total|Total of all reporting groups
557145|NCT00874276|B2|Baseline|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
557146|NCT00874276|B1|Baseline|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
557313|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1
Placebo: placebo daily"
563302|NCT00890682|E2|Reported Event|Placebo|Study Drug Injection
557102|NCT00874029|B1|Baseline|Halt Medical Acessa Procedure|In this single-arm study, subjects who have symptomatic uterine fibroids had the Acessa Procedure using the Halt Medical Proprietary Acessa System. The Acessa System delivers monopolar radiofrequency energy to tissue through a disposable electrosurgical radiofrequency (RF) Handpiece. The Generator provides sinusoidally-varying voltage at 460 kilohertz (kHz) to drive a current through the tissue to be ablated. The current delivered through the Handpiece causes controlled, local heating, resulting in targeted tissue destruction. The heat produced then disperses by conduction. During these controlled ablations, the Generator produces an alternating current which flows between the Handpiece and the dispersive electrode pads, through the body of the patient. These components, coupled with the visualization capabilities of laparoscopic ultrasound, enable the surgeon to accurately identify the patient’s uterine fibroids and treat all of her fibroids, and just the fibroids.
557103|NCT00874029|P1|Participant Flow|Halt Procedure|In this single-arm study, subjects who have symptomatic uterine fibroids will have the Halt Procedure in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.
557104|NCT00874029|O2|Outcome|How Effective Was This Treatment in Eliminating Symptoms|Patients were asked to respond in their opinion, how effective was this treatment in eliminating their symptoms.
557105|NCT00874029|O1|Outcome|Overall, Satisfaction With Uterine Fibroid Treatment|Patients were asked, overall, how satisfied with their uterine fibroid treatment.
557106|NCT00874029|O1|Outcome|Full Analysis Set - Month 12 Health Status Change|All subjects who completed the Health State Score Questionnaire (EQ-5D) at both baseline and at 12 months post treatment.
557107|NCT00874029|O2|Outcome|Full Analysis Set - Health Related Quality of Life (HRQL)|All treated subjects who met all inclusion and exclusion Criteria and who completed the HRQL questionnaire at both baseline and 12 months.
557108|NCT00874029|O1|Outcome|Full Analysis Set - Symptom Severity|All treated subjects who met all inclusion and exclusion criteria and who completed the Symptom Severity Questionnaire at Baseline and 12 months.
557109|NCT00874029|O2|Outcome|Change in Fibroid Volume|Fibroid volume assessment 12 months post treatment via contrast enhanced MRI
557110|NCT00874029|O1|Outcome|Change in Uterine Volume|Uterine volume assessment 12 months post treatment via contrast enhanced MRI
557111|NCT00874029|O1|Outcome|Surgical Reintervention 12 Months Post Treatment|The Per Protocol Set was the primary analysis set for surgical reintervention.
557112|NCT00874029|O2|Outcome|Procedural|Procedure-related events are those that the investigator considered to be definitely, probably, or possibly related to the procedure, including those related to abdominal entry and anesthesia.
557113|NCT00874029|O1|Outcome|Device Related Adverse Events|Device-related events are those that the investigator considered to be definitely, probably, or possibly related to the device.
557114|NCT00874029|O1|Outcome|Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment|"Of the 137 subjects enrolled and treated under this protocol, 124 (90.5%) were considered evaluable in terms of their 1) ability to provide a menstrual blood loss assessment, 2) lack of concomitant disease that affects the menstrual cycle, 3) baseline menstrual blood loss was within protocol inclusion limits."
557115|NCT00874029|E1|Reported Event|Safety Set|The Safety Set consisted of all subjects treated in the study.
557116|NCT00874094|B1|Baseline|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
557117|NCT00874094|P1|Participant Flow|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
557118|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
557119|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
557120|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
557121|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
557122|NCT00874094|E1|Reported Event|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
557123|NCT00874120|B3|Baseline|Total|Total of all reporting groups
557124|NCT00874120|B2|Baseline|Placebo Followed by Phenylephrine|Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
557125|NCT00874120|B1|Baseline|Phenylephrine Followed by Placebo|Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days
557126|NCT00874120|P2|Participant Flow|Placebo Followed by Phenylephrine|Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
557127|NCT00874120|P1|Participant Flow|Phenylephrine Followed by Placebo|Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days
557128|NCT00874120|O2|Outcome|Placebo|Placebo twice daily for 7 days
557129|NCT00874120|O1|Outcome|Phenylephrine|Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
557130|NCT00874120|E2|Reported Event|Placebo|Placebo twice daily for 7 days
557131|NCT00874120|E1|Reported Event|Phenylephrine|Phenylephrine HCL Extended Release tablets 30 mg twice daily for 7 days
557132|NCT00874250|B1|Baseline|GORE CTAG Device|The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
557133|NCT00874250|P1|Participant Flow|GORE CTAG Device|The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
557134|NCT00874250|O1|Outcome|GORE CTAG Device|GORE CTAG Device: Endovascular aortic stent-graft
557135|NCT00874250|O1|Outcome|GORE CTAG Device|GORE CTAG Device: Endovascular aortic stent-graft
557136|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
557137|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
557138|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
557139|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
557147|NCT00874276|P2|Participant Flow|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)
Dichloroacetate 2.5ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
557148|NCT00874276|P1|Participant Flow|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)
Dichloroacetate 2.5ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
557149|NCT00874276|O2|Outcome|At Least One EGT Allele|At least one EGT allele
557150|NCT00874276|O1|Outcome|No EGT Allele|No EGT allele
557151|NCT00874276|O2|Outcome|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)
Dichloroacetate 2.5.ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, and 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
557152|NCT00874276|O1|Outcome|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)
Dichloroacetate 2.5.ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, and 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
557153|NCT00874276|E2|Reported Event|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
557154|NCT00874276|E1|Reported Event|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
557155|NCT00874497|B3|Baseline|Total|Total of all reporting groups
557156|NCT00874497|B2|Baseline|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557157|NCT00874497|B1|Baseline|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557158|NCT00874497|P2|Participant Flow|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557159|NCT00874497|P1|Participant Flow|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557160|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557161|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557162|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557163|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557164|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557165|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557166|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557167|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557168|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557169|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557170|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557171|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557172|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557173|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557174|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557175|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557176|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557177|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557178|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557179|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557180|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557181|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557182|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557183|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557184|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557185|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557186|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557187|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557188|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557189|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557190|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557191|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557192|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557193|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557194|NCT00874497|E2|Reported Event|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
557195|NCT00874497|E1|Reported Event|Tetomilast 25 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
557196|NCT00874510|B3|Baseline|Total|Total of all reporting groups
557197|NCT00874510|B2|Baseline|Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.
Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
557198|NCT00874510|B1|Baseline|Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
557199|NCT00874510|P2|Participant Flow|Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.
Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
557200|NCT00874510|P1|Participant Flow|Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
557201|NCT00874510|O2|Outcome|Arm 2 - Mandatory Nap|"In Year 1 interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am and were asked to nap during this time
For Year 2, the mandatory sign out of cell phones and cross-coverage responsibilities was split between two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am and were asked to nap during this time"
557202|NCT00874510|O1|Outcome|Arm 1 - Standard Schedule for Years 1 and Year 2|interns work standard schedule, being on duty for 30 continuous hours
557203|NCT00874510|E2|Reported Event|Arm 2 - Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.
Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
557204|NCT00874510|E1|Reported Event|Arm 1 - Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
557205|NCT00874549|B5|Baseline|Total|Total of all reporting groups
557206|NCT00874549|B4|Baseline|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557207|NCT00874549|B3|Baseline|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557208|NCT00874549|B2|Baseline|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557209|NCT00874549|B1|Baseline|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557210|NCT00874549|P4|Participant Flow|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557211|NCT00874549|P3|Participant Flow|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557304|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone
pioglitazone: pioglitazone 45 mg"
557212|NCT00874549|P2|Participant Flow|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557213|NCT00874549|P1|Participant Flow|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557214|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557215|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557216|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557217|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557218|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557219|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557220|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557221|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557222|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557223|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557224|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557225|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557226|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557227|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557228|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557229|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557230|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557231|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557232|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557233|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557234|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557235|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557236|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557237|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557238|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557239|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557240|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557241|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557242|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557243|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557244|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557245|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557246|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557247|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557248|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557249|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557250|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557251|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557252|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557253|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557254|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557255|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557256|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557257|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557258|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557259|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557260|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557261|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557262|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557263|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557264|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557265|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557266|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557267|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557268|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557269|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557270|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
557271|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
557272|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
557273|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
557274|NCT00874549|E4|Reported Event|Menactra® Day 0 and Day 28|
557275|NCT00874549|E3|Reported Event|Menactra® Day 0 and Day 14|
557276|NCT00874549|E2|Reported Event|Menactra® Day 0 x 2|
557277|NCT00874549|E1|Reported Event|Menomune® Day 0|
557278|NCT00867659|B1|Baseline|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
557279|NCT00867659|P1|Participant Flow|Cetrotide Acetate|oocyte donors will receive 3 mg cetrotide acetate by a single injection on the day of oocyte retrieval. The incidence of OHSS will be assessed.
557280|NCT00867659|O1|Outcome|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
557281|NCT00867659|O1|Outcome|Cetrotide Acetate|oocyte donors will receive a single injection of 3 mg cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
557282|NCT00867659|E1|Reported Event|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
557283|NCT00868101|B3|Baseline|Total|Total of all reporting groups
557284|NCT00868101|B2|Baseline|Control|Children who did not receive the preconditioning stimulus
557285|NCT00868101|B1|Baseline|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
557286|NCT00868101|P2|Participant Flow|Control|Children who did not receive the preconditioning stimulus
557287|NCT00868101|P1|Participant Flow|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
557288|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
557289|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
557290|NCT00868101|O2|Outcome|Control|Children that don´t received the preconditioning stimmulus
557291|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus
557292|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
557293|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
557294|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
557295|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
557296|NCT00868101|E2|Reported Event|Control|Children who did not receive the preconditioning stimulus
557297|NCT00868101|E1|Reported Event|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
557298|NCT00868140|B3|Baseline|Total|Total of all reporting groups
557299|NCT00868140|B2|Baseline|2/Placebo|"Placebo control to arm 1
Placebo: placebo daily"
557300|NCT00868140|B1|Baseline|1/Pioglitazaone Treated|"Pioglitazone treated subjects
pioglitazone: pioglitazone 45 mg"
557301|NCT00868140|P2|Participant Flow|2/Placebo|"Placebo control to arm 1
Placebo: placebo daily"
557302|NCT00868140|P1|Participant Flow|1/Pioglitazaone Treated|"Pioglitazone treated subjects
pioglitazone: pioglitazone 45 mg"
557303|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1
Placebo: placebo daily"
557315|NCT00868140|E2|Reported Event|2/Placebo|"Placebo control to arm 1 in pill form identical to treatment form also twice per day for 6 months
Placebo: placebo daily"
557316|NCT00868140|E1|Reported Event|1/Pioglitazone|"Pioglitazone in pill form at 45mg twice per day for 6 months
pioglitazone: pioglitazone 45 mg"
557317|NCT00868192|B1|Baseline|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557318|NCT00868192|P1|Participant Flow|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557319|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557320|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557321|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557322|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557323|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557324|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557325|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557326|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557327|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557328|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557329|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557330|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557331|NCT00868192|E1|Reported Event|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle
Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
557332|NCT00868218|B5|Baseline|Total|Total of all reporting groups
557333|NCT00868218|B4|Baseline|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557334|NCT00868218|B3|Baseline|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557335|NCT00868218|B2|Baseline|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557336|NCT00868218|B1|Baseline|30µg HA Vaccine|"30µg HA vaccine Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557337|NCT00868218|P4|Participant Flow|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557338|NCT00868218|P3|Participant Flow|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557339|NCT00868218|P2|Participant Flow|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557340|NCT00868218|P1|Participant Flow|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
557341|NCT00868218|O4|Outcome|30µg HA Adjuvanted|30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
557342|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
557343|NCT00868218|O2|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered
557344|NCT00868218|O1|Outcome|1.5µg HA Adjuvanted|1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
557345|NCT00868218|O4|Outcome|30µg HA Adjuvanted|30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
557346|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
557347|NCT00868218|O2|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered
557348|NCT00868218|O1|Outcome|1.5µg HA Adjuvanted|1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
557349|NCT00868218|O4|Outcome|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557350|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557351|NCT00868218|O2|Outcome|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557352|NCT00868218|O1|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
557353|NCT00868218|E4|Reported Event|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
563303|NCT00890682|E1|Reported Event|Sky0402|Injection of Study Drug
557354|NCT00868218|E3|Reported Event|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557355|NCT00868218|E2|Reported Event|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557356|NCT00868218|E1|Reported Event|30µg HA Vaccine|"30µg HA vaccine Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
557357|NCT00868231|B1|Baseline|Overall Study Population|All patients randomized into the crossover study
557358|NCT00868231|P6|Participant Flow|Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler at in the evening for 15 consecutive days."
557359|NCT00868231|P5|Participant Flow|Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
557360|NCT00868231|P4|Participant Flow|Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the evening and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
557361|NCT00868231|P3|Participant Flow|Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
557362|NCT00868231|P2|Participant Flow|Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
557363|NCT00868231|P1|Participant Flow|Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.
In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.
In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
557364|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557365|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557366|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557367|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557368|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557369|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557370|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557371|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
563304|NCT00890695|B3|Baseline|Total|Total of all reporting groups
557372|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557373|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557374|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557375|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557376|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557377|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557378|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557379|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557380|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557381|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557382|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557383|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557384|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557385|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557386|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557387|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557388|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557389|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557390|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557391|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557392|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557393|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557394|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557395|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557396|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557397|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
557398|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557399|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557400|NCT00868231|E3|Reported Event|Placebo|Placebo via inhalation
557401|NCT00868231|E2|Reported Event|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
557402|NCT00868231|E1|Reported Event|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
557403|NCT00868296|B3|Baseline|Total|Total of all reporting groups
557404|NCT00868296|B2|Baseline|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
557405|NCT00868296|B1|Baseline|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
557406|NCT00868296|P2|Participant Flow|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
557407|NCT00868296|P1|Participant Flow|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
557408|NCT00868296|O2|Outcome|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
557584|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
557409|NCT00868296|O1|Outcome|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
557410|NCT00868296|O2|Outcome|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
557411|NCT00868296|O1|Outcome|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
557412|NCT00868296|E2|Reported Event|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
557413|NCT00868296|E1|Reported Event|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
557414|NCT00868309|B3|Baseline|Total|Total of all reporting groups
557415|NCT00868309|B2|Baseline|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
557416|NCT00868309|B1|Baseline|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
557417|NCT00868309|P2|Participant Flow|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
557418|NCT00868309|P1|Participant Flow|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
557419|NCT00868309|O2|Outcome|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
557420|NCT00868309|O1|Outcome|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
557421|NCT00868309|O2|Outcome|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
557422|NCT00868309|O1|Outcome|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
557423|NCT00868309|E2|Reported Event|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
557424|NCT00868309|E1|Reported Event|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
557425|NCT00868348|B3|Baseline|Total|Total of all reporting groups
557426|NCT00868348|B2|Baseline|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
557427|NCT00868348|B1|Baseline|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
557428|NCT00868348|P2|Participant Flow|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
557429|NCT00868348|P1|Participant Flow|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
557430|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
557431|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
557585|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
557432|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
557433|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
557434|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
557435|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
557436|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
557437|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
557438|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
557439|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
557440|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
557441|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
557442|NCT00868348|E2|Reported Event|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
557443|NCT00868348|E1|Reported Event|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
557444|NCT00868374|B3|Baseline|Total|Total of all reporting groups
557445|NCT00868374|B2|Baseline|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
557446|NCT00868374|B1|Baseline|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
557447|NCT00868374|P2|Participant Flow|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
557448|NCT00868374|P1|Participant Flow|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
557449|NCT00868374|O2|Outcome|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
557450|NCT00868374|O1|Outcome|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
557451|NCT00868374|E2|Reported Event|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
557452|NCT00868374|E1|Reported Event|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
557453|NCT00868439|B3|Baseline|Total|Total of all reporting groups
557454|NCT00868439|B2|Baseline|Placebo|"Spironolactone + Placebo
Participants received placebo (twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557455|NCT00868439|B1|Baseline|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (15 g twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557456|NCT00868439|P2|Participant Flow|Placebo|"Spironolactone + Placebo
Participants received placebo (twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557457|NCT00868439|P1|Participant Flow|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (15 g twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557458|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo
Participants received placebo (twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557732|NCT00874848|B1|Baseline|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
557459|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (15 g twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557460|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo
Participants received placebo (twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557461|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (15 g twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557462|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo
Participants received placebo (twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557463|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (15 g twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557464|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo
Participants received placebo (twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557465|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (15 g twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557466|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo
Participants received placebo (twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557467|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (15 g twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557468|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo
Participants received placebo (twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557469|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (15 g twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557470|NCT00868439|E2|Reported Event|Placebo|"Spironolactone + Placebo
Participants received placebo (twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557471|NCT00868439|E1|Reported Event|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (15 g twice daily [BID]).
Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
557472|NCT00868452|B3|Baseline|Total|Total of all reporting groups
557473|NCT00868452|B2|Baseline|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
557474|NCT00868452|B1|Baseline|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
557475|NCT00868452|P2|Participant Flow|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
557476|NCT00868452|P1|Participant Flow|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
557477|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
557478|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
557479|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
557480|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
557481|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
557482|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
557483|NCT00868452|E2|Reported Event|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
557484|NCT00868452|E1|Reported Event|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
557485|NCT00868517|B4|Baseline|Total|Total of all reporting groups
557486|NCT00868517|B3|Baseline|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.
Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
557487|NCT00868517|B2|Baseline|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture."
557488|NCT00868517|B1|Baseline|True Group Auricular Acupuncture|"Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture"
557489|NCT00868517|P3|Participant Flow|Wait-List Control Group|Served as wait-list control group. Did not receive any type of group ear acupuncture intervention--served as strict control and received conventional care only. Eligible to receive true group auricular acupuncture once study period was completed.
557490|NCT00868517|P2|Participant Flow|Sham Group Auricular Acupuncture|Received sham group auricular acupuncture.
557491|NCT00868517|P1|Participant Flow|True Group Auricular Acupuncture|Received true group auricular acupuncture.
557492|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.
Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
557493|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture."
557494|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture"
557495|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.
Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
557496|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture."
557497|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture"
557498|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.
Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
557499|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture."
557500|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture"
557501|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.
Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
557502|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture."
557503|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture"
557504|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.
Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
557505|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture."
557506|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture"
557507|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.
Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
557508|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture."
557509|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture"
557510|NCT00868517|E3|Reported Event|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.
Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
557511|NCT00868517|E2|Reported Event|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture."
557512|NCT00868517|E1|Reported Event|True Group Auricular Acupuncture|"Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture"
557513|NCT00868530|B1|Baseline|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557514|NCT00868530|P1|Participant Flow|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557515|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557516|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557517|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557518|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557519|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557520|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557521|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557522|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557523|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557524|NCT00868530|E1|Reported Event|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
557525|NCT00868699|B4|Baseline|Total|Total of all reporting groups
557526|NCT00868699|B3|Baseline|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
557527|NCT00868699|B2|Baseline|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
557528|NCT00868699|B1|Baseline|Placebo|Placebo : Placebo Comparator
557529|NCT00868699|P3|Participant Flow|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
557530|NCT00868699|P2|Participant Flow|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
557531|NCT00868699|P1|Participant Flow|Placebo|Placebo : Placebo Comparator
557532|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
557533|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
557534|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
557535|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
557536|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
557537|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
557538|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
557539|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
557540|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
557541|NCT00868699|E3|Reported Event|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
557542|NCT00868699|E2|Reported Event|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
557543|NCT00868699|E1|Reported Event|Placebo|Placebo : Placebo Comparator
557544|NCT00868712|B4|Baseline|Total|Total of all reporting groups
557545|NCT00868712|B3|Baseline|3 - Warfarin Use Chronic|Warfarin use >24 months
557546|NCT00868712|B2|Baseline|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
557547|NCT00868712|B1|Baseline|Warfarin Use Short Duration|Warfarin use for less than 6 months
557548|NCT00868712|P3|Participant Flow|3 - Warfarin Use Chronic|Warfarin use >24 months
557549|NCT00868712|P2|Participant Flow|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
557550|NCT00868712|P1|Participant Flow|Warfarin Use Short Duration|Warfarin use for less than 6 months
557551|NCT00868712|O3|Outcome|3 - Warfarin Use Chronic|Warfarin use >24 months
557552|NCT00868712|O2|Outcome|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
557553|NCT00868712|O1|Outcome|Warfarin Use Short Duration|Warfarin use for less than 6 months
557554|NCT00868712|O3|Outcome|3 - Warfarin Use Chronic|Warfarin use >24 months
557555|NCT00868712|O2|Outcome|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
557556|NCT00868712|O1|Outcome|Warfarin Use Short Duration|Warfarin use for less than 6 months
557557|NCT00868712|E3|Reported Event|3 - Warfarin Use Chronic|Warfarin use >24 months
557558|NCT00868712|E2|Reported Event|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
557559|NCT00868712|E1|Reported Event|Warfarin Use Short Duration|Warfarin use for less than 6 months
557560|NCT00868751|B1|Baseline|Tocilizumab|"Single arm study - treatment only
tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.
Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
557561|NCT00868751|P1|Participant Flow|Tocilizumab|"Single arm study - treatment only
tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.
Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
557562|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only
tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.
Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
557563|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only
tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.
Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
557564|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only
tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.
Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
557565|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only
tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.
Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
557586|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
557566|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only
tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.
Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
557567|NCT00868751|E1|Reported Event|Tocilizumab|"Single arm study - treatment only
tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.
Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
557568|NCT00868790|B1|Baseline|All Randomized Participants|All randomized participants who took at least one dose of study treatment
557569|NCT00868790|P14|Participant Flow|METF→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 14)|Domiciled participants received oral treatment with metformin 1000 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to metformin for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4. Participants in this arm were administered active metformin during Period 1 and metformin placebo during Period 2.
557570|NCT00868790|P13|Participant Flow|PLA→METF→MK-3577 QD AM→MK-3577 QD PM (Arm 13)|Domiciled participants received oral treatment with dose-matched placebo to metformin (METF) for 4 weeks during Period 1, followed by metformin 1000 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Participants in this arm were administered metformin placebo during Period 1 and active metformin during Period 2.
557571|NCT00868790|P12|Participant Flow|MK-3577 BID→MK-3577 QD AM→PLA→MK-3577 QD PM (Arm 12)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
557572|NCT00868790|P11|Participant Flow|MK-3577 QD PM→PLA→MK-3577 QD AM→MK-3577 BID (Arm 11)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
557573|NCT00868790|P10|Participant Flow|MK-3577 QD AM→MK-3577 BID→MK-3577 QD PM→PLA (Arm 10)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
557574|NCT00868790|P9|Participant Flow|PLA→MK-3577 QD PM→MK-3577 BID→MK-3577 QD AM (Arm 9)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
557575|NCT00868790|P8|Participant Flow|MK-3577 BID→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 8)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
557576|NCT00868790|P7|Participant Flow|MK-3577 QD PM→MK-3577 QD AM→MK-3577 BID→PLA (Arm 7)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
557577|NCT00868790|P6|Participant Flow|MK-3577 QD AM→MK-3577 QD PM→PLA→MK-3577 BID (Arm 6)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4.
557578|NCT00868790|P5|Participant Flow|PLA→MK-3577 BID→MK-3577 QD AM→MK-3577 QD PM (Arm 5)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
557579|NCT00868790|P4|Participant Flow|MK-3577 BID→MK-3577 QD PM→MK-3577 QD AM→PLA (Arm 4)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
557580|NCT00868790|P3|Participant Flow|MK-3577 QD PM→MK-3577 BID→PLA→MK-3577 QD AM (Arm 3)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed MK- 3577 25 mg BID for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
557581|NCT00868790|P2|Participant Flow|MK-3577 QD AM→PLA→MK-3577 BID→MK-3577 QD PM (Arm 2)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
557582|NCT00868790|P1|Participant Flow|PLA→MK-3577 QD AM→MK-3577 QD PM→MK-3577 BID (Arm 1)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
557583|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
557587|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
557588|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
557589|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
557590|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
557591|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
557592|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
557593|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
557594|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
557595|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
557596|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
557597|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
557598|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
557599|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
557600|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
557601|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
557602|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
557603|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
557604|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
557605|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
557606|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
557607|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
557608|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID 4 weeks (received during Period 1 or 2 only).
557609|NCT00868790|O4|Outcome|MK-3577 BID|Domiciled participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
557610|NCT00868790|O3|Outcome|MK-3577 PM|Domiciled participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
557611|NCT00868790|O2|Outcome|MK-3577 AM|Domiciled participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks
557612|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
557613|NCT00868790|E5|Reported Event|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
557614|NCT00868790|E4|Reported Event|MK-3577 BID|Participants received 25 mg MK-3577 orally BID for 4 weeks.
557615|NCT00868790|E3|Reported Event|MK-3577 PM|Participants received 6 mg MK-3577 orally QD in the PM for 4 weeks.
557616|NCT00868790|E2|Reported Event|MK-3577 AM|Participants received 10 mg MK-3577 orally QD in the AM for 4 weeks.
557617|NCT00868790|E1|Reported Event|Placebo|Participants received a placebo tablet matching the respective MK-3577 dose (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
557618|NCT00868959|B1|Baseline|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
557619|NCT00868959|P1|Participant Flow|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
557620|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
557621|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
557622|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
557623|NCT00868959|E1|Reported Event|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
557624|NCT00868998|B1|Baseline|Treatment|Gemcitabine, Docetaxel, and Capecitabine
557625|NCT00868998|P1|Participant Flow|Treatment|Gemcitabine, Docetaxel, and Capecitabine
557626|NCT00868998|O1|Outcome|Treatment|Gemcitabine, Docetaxel, and Capecitabine
557627|NCT00868998|O1|Outcome|Treatment|Gemcitabine, Docetaxel, and Capecitabine
557628|NCT00868998|E1|Reported Event|Treatment|Gemcitabine, Docetaxel, and Capecitabine
557629|NCT00869050|B1|Baseline|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
557653|NCT00869141|O1|Outcome|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
557817|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
557630|NCT00869050|P1|Participant Flow|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
557631|NCT00869050|O1|Outcome|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
557632|NCT00869050|O1|Outcome|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
557633|NCT00869050|E1|Reported Event|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
557634|NCT00869089|B1|Baseline|CC-10004|CC-10004 Treatment
557635|NCT00869089|P1|Participant Flow|CC-10004|"CC-10004 treatment:
30mg,oral medication, BID, for 24 weeks (60mg total DAILY)"
557636|NCT00869089|O1|Outcome|CC-10004|CC-10004 treatment
557637|NCT00869089|E1|Reported Event|CC-10004|CC-10004: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
557638|NCT00869128|B1|Baseline|Entire Study Population|Subjects were treated for 3 weeks with 1 tablet per night of Placebo or Circadin and then 3 weeks of Circadin or Placebo, respectively.
557639|NCT00869128|P2|Participant Flow|Circadin First|Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg and then with Placebo.
557640|NCT00869128|P1|Participant Flow|Placebo First|Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
557641|NCT00869128|O2|Outcome|Circadin|Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg
557642|NCT00869128|O1|Outcome|Placebo|Subjects were treated for 3 weeks with 1 tablet per night of Placebo
557643|NCT00869141|B3|Baseline|Total|Total of all reporting groups
557644|NCT00869141|B2|Baseline|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
557645|NCT00869141|B1|Baseline|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
557646|NCT00869141|P2|Participant Flow|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
557647|NCT00869141|P1|Participant Flow|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
557648|NCT00869141|O2|Outcome|Non-hypertensive Phase Group|Eyes that did not develop hypertensive phase after Ahmed valve implantation
557649|NCT00869141|O1|Outcome|Hypertensive Phase Group|Eyes that developed hypertensive phase after Ahmed valve implantation
557650|NCT00869141|O2|Outcome|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
557651|NCT00869141|O1|Outcome|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
557652|NCT00869141|O2|Outcome|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
557729|NCT00874822|E1|Reported Event|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
557654|NCT00869141|E2|Reported Event|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
557655|NCT00869141|E1|Reported Event|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
557656|NCT00869167|B3|Baseline|Total|Total of all reporting groups
557657|NCT00869167|B2|Baseline|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557658|NCT00869167|B1|Baseline|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557659|NCT00869167|P2|Participant Flow|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557660|NCT00869167|P1|Participant Flow|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557661|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime
557662|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime
557663|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557664|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557665|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557666|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557667|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557668|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557669|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557670|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557671|NCT00869167|E2|Reported Event|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557672|NCT00869167|E1|Reported Event|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
557673|NCT00869258|B1|Baseline|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
557674|NCT00869258|P1|Participant Flow|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
557675|NCT00869258|O1|Outcome|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
557676|NCT00869258|E1|Reported Event|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
557677|NCT00869323|B1|Baseline|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
557678|NCT00869323|P1|Participant Flow|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
557679|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
557680|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
557681|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
557682|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
557683|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
557684|NCT00869323|E1|Reported Event|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
557685|NCT00874770|B5|Baseline|Total|Total of all reporting groups
557686|NCT00874770|B4|Baseline|Placebo+pegIFNα-2a+Ribavirin|Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557687|NCT00874770|B3|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin|Participants received 60-mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557688|NCT00874770|B2|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin|Participants received 10-mg of daclatasvir OD in coadministration with pegIFNα-2a-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557689|NCT00874770|B1|Baseline|Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557690|NCT00874770|P4|Participant Flow|Placebo+pegIFNα-2a+Ribavirin|Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557691|NCT00874770|P3|Participant Flow|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557692|NCT00874770|P2|Participant Flow|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα-2a 180 µg given subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557693|NCT00874770|P1|Participant Flow|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557694|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets once daily for 48 weeks coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557695|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557696|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557697|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557698|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).48 weeks.
557699|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557700|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557701|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Riibavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557702|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557703|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557704|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557705|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557706|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weekswith pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557707|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557708|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10-mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557730|NCT00874848|B3|Baseline|Total|Total of all reporting groups
557731|NCT00874848|B2|Baseline|Control Arm|Cetuximab + Paclitaxel/Carboplatin
557709|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557710|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557711|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557712|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557713|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557714|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557715|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557716|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557717|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Rribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557718|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557719|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557720|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557721|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557722|NCT00874770|E4|Reported Event|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks in with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557723|NCT00874770|E3|Reported Event|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557724|NCT00874770|E2|Reported Event|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557725|NCT00874770|E1|Reported Event|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
557726|NCT00874822|B1|Baseline|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
557727|NCT00874822|P1|Participant Flow|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
557728|NCT00874822|O1|Outcome|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
557733|NCT00874848|P2|Participant Flow|Control Arm|"Cetuximab infusion:
initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;
Paclitaxel infusion:
200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Carboplatin infusion:
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor."
557734|NCT00874848|P1|Participant Flow|Imprime PGG Arm|"Imprime PGG® infusion:
4 mg/kg i.v. over 2 to 4 hrs on Days 1, 8 and 15 of each 3-week treatment cycle;
Cetuximab infusion:
initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;
Paclitaxel infusion:
200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Carboplatin infusion:
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of Imprime PGG and cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor."
557735|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
557736|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
557737|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
557738|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
557739|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
557740|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
557741|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
557742|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
557743|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
557744|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
557745|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
557746|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
557747|NCT00874848|E2|Reported Event|Control Arm|Cetuximab + Paclitaxel/Carboplatin
557748|NCT00874848|E1|Reported Event|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
557749|NCT00874887|B3|Baseline|Total|Total of all reporting groups
557750|NCT00874887|B2|Baseline|Zymar®|Gatifloxacin 0.3% ophthalmic solution
557751|NCT00874887|B1|Baseline|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
557752|NCT00874887|P2|Participant Flow|Zymar®|Gatifloxacin 0.3% ophthalmic solution
557753|NCT00874887|P1|Participant Flow|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
557754|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
557755|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
557756|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
557757|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
557758|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
557759|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
557760|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
557761|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
557762|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
557763|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
557764|NCT00874887|E2|Reported Event|Zymar®|Gatifloxacin 0.3% ophthalmic solution
557765|NCT00874887|E1|Reported Event|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
557766|NCT00874939|B1|Baseline|All Participants|All enrolled participants
557767|NCT00874939|P1|Participant Flow|All Participants|All enrolled participants
557768|NCT00874939|O2|Outcome|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
557769|NCT00874939|O1|Outcome|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
557770|NCT00874939|O2|Outcome|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
557771|NCT00874939|O1|Outcome|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
557772|NCT00874939|O2|Outcome|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
557773|NCT00874939|O1|Outcome|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
557774|NCT00874939|O2|Outcome|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
557775|NCT00874939|O1|Outcome|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
557776|NCT00874939|E4|Reported Event|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
557777|NCT00874939|E3|Reported Event|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
557778|NCT00874939|E2|Reported Event|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
557779|NCT00874939|E1|Reported Event|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
557780|NCT00875017|B7|Baseline|Total|Total of all reporting groups
557781|NCT00875017|B6|Baseline|Sequence 6|Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
557782|NCT00875017|B5|Baseline|Sequence 5|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
557783|NCT00875017|B4|Baseline|Sequence 4|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
557784|NCT00875017|B3|Baseline|Sequence 3|Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
557785|NCT00875017|B2|Baseline|Sequence 2|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
557786|NCT00875017|B1|Baseline|Sequence 1|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
557787|NCT00875017|P6|Participant Flow|Sequence 6|Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
557788|NCT00875017|P5|Participant Flow|Sequence 5|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
557789|NCT00875017|P4|Participant Flow|Sequence 4|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
557790|NCT00875017|P3|Participant Flow|Sequence 3|Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
557791|NCT00875017|P2|Participant Flow|Sequence 2|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
557792|NCT00875017|P1|Participant Flow|Sequence 1|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
557793|NCT00875017|O3|Outcome|Meal Only|A meal containing a known amount of calcium is ingested. No phosphorous binder is administered. 10 hours post-meal, rectal effluent is collected and the amount of calcium is measured.
557794|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of calcium is ingested along with oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of calcium is measured.
557795|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of calcium is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of calcium is measured.
557796|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
557797|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
557798|NCT00875017|O3|Outcome|Meal Only|A meal containing a known amount of phosphorous is ingested. No phosphorous binder is administered. 10 hours post-meal, rectal effluent is collected and the amount of phosphorous is measured.
557799|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of phosphorous is ingested along wuith oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
557800|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
557801|NCT00875017|E4|Reported Event|Fasting|
557802|NCT00875017|E3|Reported Event|Meal Only|
557803|NCT00875017|E2|Reported Event|Sevelamer Carbonate|
557804|NCT00875017|E1|Reported Event|Lanthanum Carbonate|
557805|NCT00875420|B6|Baseline|Total|Total of all reporting groups
557806|NCT00875420|B5|Baseline|Placebo|Oral once a day for 28 days
557807|NCT00875420|B4|Baseline|RAD1901 100 mg|Oral once a day for 28 days
557808|NCT00875420|B3|Baseline|RAD1901 50 mg|Oral once a day for 28 days
557809|NCT00875420|B2|Baseline|RAD1901 25 mg|Oral once a day for 28 days
557810|NCT00875420|B1|Baseline|RAD1901 10 mg|Oral once a day for 28 days
557811|NCT00875420|P5|Participant Flow|Placebo|Oral once a day for 28 days
557812|NCT00875420|P4|Participant Flow|RAD1901 100 mg|Oral once a day for 28 days
557813|NCT00875420|P3|Participant Flow|RAD1901 50 mg|Oral once a day for 28 days
557814|NCT00875420|P2|Participant Flow|RAD1901 25 mg|Oral once a day for 28 days
557815|NCT00875420|P1|Participant Flow|RAD1901 10 mg|Oral once a day for 28 days
557816|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
557837|NCT00875420|E4|Reported Event|RAD1901 100 mg|Oral once a day for 28 days
557838|NCT00875420|E3|Reported Event|RAD1901 50 mg|Oral once a day for 28 days
557839|NCT00875420|E2|Reported Event|RAD1901 25 mg|Oral once a day for 28 days
557840|NCT00875420|E1|Reported Event|RAD1901 10 mg|Oral once a day for 28 days
557841|NCT00875433|B1|Baseline|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557842|NCT00875433|P1|Participant Flow|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557843|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557844|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557845|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557846|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557847|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557848|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557849|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557850|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557851|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557852|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557853|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557854|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557855|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557856|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557857|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557858|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557859|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557860|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557861|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557978|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|Group P - group with parenterally supplemented glutamine
563305|NCT00890695|B2|Baseline|2 Normal Diet|normal diet arm
557862|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557863|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557864|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557865|NCT00875433|E1|Reported Event|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
557866|NCT00875485|B3|Baseline|Total|Total of all reporting groups
557867|NCT00875485|B2|Baseline|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557868|NCT00875485|B1|Baseline|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557869|NCT00875485|P2|Participant Flow|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557870|NCT00875485|P1|Participant Flow|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557871|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557872|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557873|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557874|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557875|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557876|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557877|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557878|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557879|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557880|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557881|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557882|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557883|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557884|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557885|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557886|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557887|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557888|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557889|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557890|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557891|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557892|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557893|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557894|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557895|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557896|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557979|NCT00875797|E2|Reported Event|Group E|Group E - group with enterally supplemented glutamine
557897|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557898|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557899|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557900|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557901|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557902|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557903|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557904|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557905|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557906|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557907|NCT00875485|E2|Reported Event|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
557908|NCT00875485|E1|Reported Event|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
557909|NCT00875550|B3|Baseline|Total|Total of all reporting groups
557910|NCT00875550|B2|Baseline|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores."
557911|NCT00875550|B1|Baseline|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores."
557912|NCT00875550|P2|Participant Flow|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores."
557913|NCT00875550|P1|Participant Flow|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores."
557914|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores"
557915|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores"
557916|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores"
557917|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores"
557918|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores"
557919|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores"
557920|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores"
557921|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores"
557922|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores"
557980|NCT00875797|E1|Reported Event|Group P|Group P - group with parenterally supplemented glutamine
557923|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores"
557924|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores."
557925|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores."
557926|NCT00875550|E2|Reported Event|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores."
557927|NCT00875550|E1|Reported Event|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores."
557928|NCT00875563|B1|Baseline|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
557929|NCT00875563|P1|Participant Flow|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
557930|NCT00875563|O1|Outcome|Zenith® Fenestrated AAA Endovascular Graft|
557931|NCT00875563|E1|Reported Event|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
557932|NCT00875589|B3|Baseline|Total|Total of all reporting groups
557933|NCT00875589|B2|Baseline|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
557934|NCT00875589|B1|Baseline|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
557935|NCT00875589|P2|Participant Flow|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
557936|NCT00875589|P1|Participant Flow|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
557937|NCT00875589|O2|Outcome|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
557938|NCT00875589|O1|Outcome|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
557939|NCT00875589|E2|Reported Event|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
557940|NCT00875589|E1|Reported Event|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
557941|NCT00875615|B1|Baseline|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
557942|NCT00875615|P1|Participant Flow|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
557943|NCT00875615|O1|Outcome|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
557944|NCT00875615|O1|Outcome|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
557945|NCT00875615|E1|Reported Event|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
557946|NCT00875706|B4|Baseline|Total|Total of all reporting groups
557947|NCT00875706|B3|Baseline|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
557948|NCT00875706|B2|Baseline|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
557949|NCT00875706|B1|Baseline|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.
The educational intervention is included in this arm."
558092|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
558649|NCT00877487|E1|Reported Event|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
557950|NCT00875706|P3|Participant Flow|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
557951|NCT00875706|P2|Participant Flow|Data Collection - Survey|"Survey data collection tools were piloted to assess feasibility of survey administration and development for use in a long-term care setting. These tools were piloted in sites where the educational intervention was administered.
The survey was a modified version of the Care Coordination Survey which was originally validated in a hospital setting (citation below). The survey pertains to work context factors that shape practice, including staffing and resources, communication and IT, participation in decision-making, relationships with supervisors, professional empowerment, and relational coordination. Modifications were made for use of the survey in a VA Community Living Centers.
Weinberg, D., J. Perloff, D. Cooney-Miner, and E. Glaser, Supporting work and workers: Validation of a hospital work organization survey for professional and paraprofessional workers. 2008."
557952|NCT00875706|P1|Participant Flow|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.
The educational intervention is included in this arm.
Educational Intervention: The intervention consists of two (2) different types of training, both to be delivered through a train-the-trainer approach. The first of these is coaching-supervision training for nurse managers and other supervisory personnel in the CLC units. The second component is a one-day training for DCWs on communication and managing problem behaviors associated with dementia. These two trainings build on validated training models that have been developed by PHINational, but will be adapted and customized to include VA-developed clinical content on the management of problem behaviors associated with dementia."
557953|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
557954|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
557955|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.
The educational intervention is included in this arm."
557956|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
557957|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
557958|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.
The educational intervention is included in this arm."
557959|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
557960|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
557961|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.
The educational intervention is included in this arm."
557962|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
557963|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
557964|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.
The educational intervention is included in this arm."
557965|NCT00875706|E3|Reported Event|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
557966|NCT00875706|E2|Reported Event|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
557967|NCT00875706|E1|Reported Event|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.
The educational intervention is included in this arm."
557968|NCT00875797|B3|Baseline|Total|Total of all reporting groups
557969|NCT00875797|B2|Baseline|Enteral Glutamine|enteral glutamine supplementation
557970|NCT00875797|B1|Baseline|Parenteral Glutamine|parenteral glutamine supplementation
557971|NCT00875797|P2|Participant Flow|Group E|Group E - group with enterally supplemented glutamine
557972|NCT00875797|P1|Participant Flow|Group P|Group P - group with parenterally supplemented glutamine
557973|NCT00875797|O2|Outcome|Group E - Enteral Glutamine|enteral glutamine supplementation
557974|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|parenteral glutamine supplementation
557975|NCT00875797|O2|Outcome|Group - Enteral Glutamine|Group E - group with enterally supplemented glutamine
557976|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|Group P - group with parenterally supplemented glutamine
557977|NCT00875797|O2|Outcome|Group E - Enteral Glutamine|Group E - group with enterally supplemented glutamine
558650|NCT00877604|B3|Baseline|Total|Total of all reporting groups
557981|NCT00875810|B1|Baseline|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
557982|NCT00875810|P1|Participant Flow|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
557983|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
557984|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
557985|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
557986|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
557987|NCT00875810|E1|Reported Event|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
557988|NCT00875836|B3|Baseline|Total|Total of all reporting groups
557989|NCT00875836|B2|Baseline|Placebo|Placebo: 30 mg capsules twice daily
557990|NCT00875836|B1|Baseline|Buspirone|Buspirone: 30 mg capsules twice daily
557991|NCT00875836|P2|Participant Flow|Placebo|Placebo: Flexible dose up to 60mg/day
557992|NCT00875836|P1|Participant Flow|Buspirone|Buspirone: Flexible dose up to 60 mg/day
557993|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
557994|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
557995|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
557996|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
557997|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
557998|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
557999|NCT00875836|E2|Reported Event|Placebo|Placebo: Flexible dose up to 60mg/day
558000|NCT00875836|E1|Reported Event|Buspirone|Buspirone: Flexible dose up to 60 mg/day
558001|NCT00875979|B3|Baseline|Total|Total of all reporting groups
558002|NCT00875979|B2|Baseline|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
558003|NCT00875979|B1|Baseline|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
558004|NCT00875979|P2|Participant Flow|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
558005|NCT00875979|P1|Participant Flow|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
558006|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
558007|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
558008|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
558009|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
558010|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
564749|NCT00895531|E2|Reported Event|Depodur Group|
558011|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
558012|NCT00875979|E2|Reported Event|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
558013|NCT00875979|E1|Reported Event|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
558014|NCT00876018|B4|Baseline|Total|Total of all reporting groups
558015|NCT00876018|B3|Baseline|Control Group B (No Intervention)|Participants were not administered with any intervention.
558016|NCT00876018|B2|Baseline|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558017|NCT00876018|B1|Baseline|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558018|NCT00876018|P3|Participant Flow|Control Group B (No Intervention)|Participants were not administered with any intervention.
558019|NCT00876018|P2|Participant Flow|Control Group A (Un-fortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558020|NCT00876018|P1|Participant Flow|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40 gram (g) in 100 milliliter (mL) water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558021|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558022|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558023|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558024|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558025|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558026|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558027|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558028|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558029|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558030|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558031|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558032|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558033|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558137|NCT00876447|E21|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 11|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558034|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558035|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558036|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558037|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558038|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558039|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558040|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558041|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558042|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558043|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558044|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558045|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558046|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558047|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558048|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558049|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558050|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558051|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558052|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558053|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558054|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558055|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558056|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558057|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
559393|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
558058|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558059|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558060|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558061|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558062|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558063|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558064|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558065|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558066|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
558067|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558068|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558069|NCT00876018|E3|Reported Event|Control Group B (No Intervention)|Participants were not administered with any intervention.
558070|NCT00876018|E2|Reported Event|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558071|NCT00876018|E1|Reported Event|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
558072|NCT00876265|B1|Baseline|Overall Study|
558073|NCT00876265|P1|Participant Flow|Overall Study|
558074|NCT00876265|O2|Outcome|Zyplast|Zyplast was injected into the opposite nasolabial fold that Belotero was injected into.
558075|NCT00876265|O1|Outcome|Belotero|Belotero was injected into the left or right nasolabial fold using a randomization schedule.
558076|NCT00876265|E2|Reported Event|Zyplast|
558077|NCT00876265|E1|Reported Event|Belotero|
558078|NCT00876343|B4|Baseline|Total|Total of all reporting groups
558079|NCT00876343|B3|Baseline|Placebo Group|Placebo were administered orally once daily
558080|NCT00876343|B2|Baseline|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
558081|NCT00876343|B1|Baseline|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
558082|NCT00876343|P3|Participant Flow|Placebo Group|Placebo were administered orally once daily
558083|NCT00876343|P2|Participant Flow|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
558084|NCT00876343|P1|Participant Flow|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
558085|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
558086|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
558087|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
558088|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
558089|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
558090|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
558091|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
558093|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
558094|NCT00876343|E3|Reported Event|Placebo Group|Placebo were administered orally once daily
558095|NCT00876343|E2|Reported Event|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
558096|NCT00876343|E1|Reported Event|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
558097|NCT00876447|B3|Baseline|Total|Total of all reporting groups
558098|NCT00876447|B2|Baseline|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558099|NCT00876447|B1|Baseline|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558100|NCT00876447|P2|Participant Flow|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558101|NCT00876447|P1|Participant Flow|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558102|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558103|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558104|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558105|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558106|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558107|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558108|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558109|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558110|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558111|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558112|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558113|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558114|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558115|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558116|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558117|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558118|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558119|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558120|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558121|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558122|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558123|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558124|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558125|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558126|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558127|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558128|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558129|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558130|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558131|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
558132|NCT00876447|E26|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 13|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558133|NCT00876447|E25|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 13|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558134|NCT00876447|E24|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 12|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558135|NCT00876447|E23|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 12|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558136|NCT00876447|E22|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 11|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558138|NCT00876447|E20|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 10|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558139|NCT00876447|E19|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 10|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558140|NCT00876447|E18|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 9|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558141|NCT00876447|E17|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 9|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558142|NCT00876447|E16|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 8|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558143|NCT00876447|E15|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 8|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558144|NCT00876447|E14|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 7|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558145|NCT00876447|E13|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 7|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558146|NCT00876447|E12|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 6|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558147|NCT00876447|E11|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 6|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558148|NCT00876447|E10|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 5|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558149|NCT00876447|E9|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 5|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558150|NCT00876447|E8|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 4|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558151|NCT00876447|E7|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 4|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558152|NCT00876447|E6|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 3|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558153|NCT00876447|E5|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 3|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558154|NCT00876447|E4|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 2|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558155|NCT00876447|E3|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 2|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558156|NCT00876447|E2|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 1|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
558157|NCT00876447|E1|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 1|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
558158|NCT00876460|B9|Baseline|Total|Total of all reporting groups
558159|NCT00876460|B8|Baseline|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558160|NCT00876460|B7|Baseline|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558161|NCT00876460|B6|Baseline|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558162|NCT00876460|B5|Baseline|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558163|NCT00876460|B4|Baseline|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558164|NCT00876460|B3|Baseline|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558165|NCT00876460|B2|Baseline|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558166|NCT00876460|B1|Baseline|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558167|NCT00876460|P8|Participant Flow|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
559394|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
558168|NCT00876460|P7|Participant Flow|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558169|NCT00876460|P6|Participant Flow|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558170|NCT00876460|P5|Participant Flow|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558171|NCT00876460|P4|Participant Flow|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558172|NCT00876460|P3|Participant Flow|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558173|NCT00876460|P2|Participant Flow|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558174|NCT00876460|P1|Participant Flow|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558175|NCT00876460|O3|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
558176|NCT00876460|O2|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
558177|NCT00876460|O1|Outcome|Docetaxel 50 mg/m2|Patients with Docetaxel 50 mg/m2
558178|NCT00876460|O3|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
558179|NCT00876460|O2|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
558180|NCT00876460|O1|Outcome|Docetaxel 50 mg/m2|Patients with Docetaxel 50 mg/m2
558181|NCT00876460|O2|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
558182|NCT00876460|O1|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
558183|NCT00876460|O2|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
558184|NCT00876460|O1|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
558185|NCT00876460|O3|Outcome|Nintedanib 200 mg|Patients with Nintedanib 200 mg b.i.d.
558186|NCT00876460|O2|Outcome|Nintedanib 150 mg|Patients with Nintedanib 150 mg b.i.d.
558187|NCT00876460|O1|Outcome|Nintedanib 100 mg|Patients with Nintedanib 100 mg b.i.d.
558188|NCT00876460|O3|Outcome|Nintedanib 200 mg|Patients with Nintedanib 200 mg b.i.d.
558189|NCT00876460|O2|Outcome|Nintedanib 150 mg|Patients with Nintedanib 150 mg b.i.d.
558190|NCT00876460|O1|Outcome|Nintedanib 100 mg|Patients with Nintedanib 100 mg b.i.d.
558191|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558192|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558193|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558194|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558195|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558196|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558197|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558262|NCT00876694|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558198|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558199|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558200|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558201|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558202|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558203|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558204|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558205|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558206|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558207|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558208|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558209|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558210|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558211|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558212|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558213|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558214|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558215|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558216|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558217|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558468|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558218|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558219|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558220|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558221|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558222|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558223|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558224|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558225|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558226|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558227|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558228|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558229|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558230|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558231|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558232|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558233|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558234|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558235|NCT00876460|E8|Reported Event|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558236|NCT00876460|E7|Reported Event|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
564750|NCT00895531|E1|Reported Event|Peripheral Nerve Group|
558237|NCT00876460|E6|Reported Event|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558238|NCT00876460|E5|Reported Event|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558239|NCT00876460|E4|Reported Event|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558240|NCT00876460|E3|Reported Event|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558241|NCT00876460|E2|Reported Event|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558242|NCT00876460|E1|Reported Event|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
558243|NCT00876694|B3|Baseline|Total|Total of all reporting groups
558244|NCT00876694|B2|Baseline|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558245|NCT00876694|B1|Baseline|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558246|NCT00876694|P2|Participant Flow|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558247|NCT00876694|P1|Participant Flow|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558248|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558249|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558250|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558251|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558252|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558253|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558254|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558255|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558256|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558257|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558258|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558259|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558260|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558261|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558263|NCT00876694|E1|Reported Event|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
558264|NCT00876733|B5|Baseline|Total|Total of all reporting groups
558265|NCT00876733|B4|Baseline|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558266|NCT00876733|B3|Baseline|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558267|NCT00876733|B2|Baseline|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558268|NCT00876733|B1|Baseline|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558269|NCT00876733|P4|Participant Flow|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558270|NCT00876733|P3|Participant Flow|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558271|NCT00876733|P2|Participant Flow|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558272|NCT00876733|P1|Participant Flow|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558273|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558274|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558275|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558276|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558277|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558278|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558279|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558280|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558281|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558282|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558283|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558284|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558285|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558286|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558287|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558288|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558289|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558290|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558291|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558292|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558293|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558294|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558295|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558296|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558297|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558298|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558299|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558300|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558301|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558302|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558303|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558304|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558305|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558306|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558307|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558308|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558309|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558310|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558311|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558312|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558313|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558314|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558315|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558316|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558317|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558318|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558319|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558320|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558321|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558322|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558323|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558324|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558325|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558326|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558327|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558328|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558329|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558330|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558331|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558332|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558333|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558334|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558335|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558336|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558337|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558338|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558339|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558340|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558341|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558342|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558343|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558344|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558345|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558346|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558347|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558348|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558349|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558350|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558351|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558352|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558353|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558354|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558355|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558356|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558357|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558358|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558359|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558360|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558361|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558362|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558363|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558364|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558365|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558366|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558367|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558368|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558369|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558370|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558371|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558372|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558373|NCT00876733|E4|Reported Event|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
558374|NCT00876733|E3|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
558375|NCT00876733|E2|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
558376|NCT00876733|E1|Reported Event|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
558377|NCT00876915|B4|Baseline|Total|Total of all reporting groups
558378|NCT00876915|B3|Baseline|Low Risk|Ambulatory cancer patients deemed Low risk based on a Khorona score of 0-2
558379|NCT00876915|B2|Baseline|High Risk Randomized to No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
558380|NCT00876915|B1|Baseline|High Risk Randomized to Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
558469|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558381|NCT00876915|P3|Participant Flow|Low or Medium Risk Group|Subjects deemed low or medium risk for VTE by Khorona score. These subjects did not enter into the study but supplied a one-time baseline blood sample for use as a control in the studies Secondary Objective of establishing the value of TF as a predictive marker for VTE.
558382|NCT00876915|P2|Participant Flow|High Risk No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
558383|NCT00876915|P1|Participant Flow|High Risk Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
558384|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
558385|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
558386|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
558387|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
558388|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
558389|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
558390|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
558391|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
558392|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
558393|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
558394|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
558395|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
558396|NCT00876915|O2|Outcome|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
558397|NCT00876915|O1|Outcome|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
558398|NCT00876915|O2|Outcome|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
558399|NCT00876915|O1|Outcome|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
558400|NCT00876915|E2|Reported Event|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
558401|NCT00876915|E1|Reported Event|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
558402|NCT00876928|B3|Baseline|Total|Total of all reporting groups
558403|NCT00876928|B2|Baseline|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
558404|NCT00876928|B1|Baseline|Placebo|Subjects with low vitamin D levels and pre-diabetes
558405|NCT00876928|P2|Participant Flow|Vitamin D|"Subjects with low vitamin D levels and pre-diabetes
Liquid vitamin D3 dissolved in medium chain triglyceride once per week"
558406|NCT00876928|P1|Participant Flow|Placebo|"Subjects with low vitamin D levels and pre-diabetes
Medium chain triglyceride given once per week"
558407|NCT00876928|O2|Outcome|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
558408|NCT00876928|O1|Outcome|Placebo|Subjects with low vitamin D levels and pre-diabetes
558409|NCT00876928|O2|Outcome|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
558410|NCT00876928|O1|Outcome|Placebo|Subjects with low vitamin D levels and pre-diabetes
558411|NCT00876928|E2|Reported Event|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
558412|NCT00876928|E1|Reported Event|Placebo|Subjects with low vitamin D levels and pre-diabetes
558413|NCT00877006|B3|Baseline|Total|Total of all reporting groups
558414|NCT00877006|B2|Baseline|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558415|NCT00877006|B1|Baseline|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558470|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558471|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
558472|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558416|NCT00877006|P2|Participant Flow|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558417|NCT00877006|P1|Participant Flow|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558418|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558419|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558420|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558421|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558422|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558423|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558424|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"R-CHOP, consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, doxorubicin at 50 mg/m2 by iv over 3-5 minutes on day 1, cyclophosphamide iv at 750 mg/m2 on day 1.
R-CVP consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, only 1 of the following doses of cyclophosphamide throughout the study: cyclophosphamide at 750 mg/m2 iv on day 1 or cyclophosphamide at 1000 mg/m2 iv on day 1."
558425|NCT00877006|O1|Outcome|Bendamustine/Rituximab|bendamustine at 90 mg/m2 iv on days 1 and 2 and rituximab at 375 mg/m2 iv infusion on day 1
558426|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558427|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558428|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558429|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558430|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558431|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558432|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558433|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558434|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558435|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558436|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558437|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558438|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558439|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558440|NCT00877006|E2|Reported Event|R-CHOP/CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
558441|NCT00877006|E1|Reported Event|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
558442|NCT00877032|B8|Baseline|Total|Total of all reporting groups
558443|NCT00877032|B7|Baseline|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
558444|NCT00877032|B6|Baseline|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558445|NCT00877032|B5|Baseline|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558446|NCT00877032|B4|Baseline|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558447|NCT00877032|B3|Baseline|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558448|NCT00877032|B2|Baseline|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558449|NCT00877032|B1|Baseline|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558450|NCT00877032|P7|Participant Flow|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
558451|NCT00877032|P6|Participant Flow|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558452|NCT00877032|P5|Participant Flow|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558453|NCT00877032|P4|Participant Flow|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558454|NCT00877032|P3|Participant Flow|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558455|NCT00877032|P2|Participant Flow|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558456|NCT00877032|P1|Participant Flow|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558457|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
558458|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558459|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558460|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558461|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558462|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558463|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558464|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
558465|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558466|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558467|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
559995|NCT00875212|O3|Outcome|Fluoride|intrvention of using a 1,500 ppm fluoridated dentifrice
558473|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558474|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558475|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558476|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558477|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558478|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
558479|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558480|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558481|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558482|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558483|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558484|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558485|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558486|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558487|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558488|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558489|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558490|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558491|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558492|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558493|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558494|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558495|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558496|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558497|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558498|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558499|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558500|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558501|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558502|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558503|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558504|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558505|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558506|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558507|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558508|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558509|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558510|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558511|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558512|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558513|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558514|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558515|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558516|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558517|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558518|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
564751|NCT00895583|B3|Baseline|Total|Total of all reporting groups
558519|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558520|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558521|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558522|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558523|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558524|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558525|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558526|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558527|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558528|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558529|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558530|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558531|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558532|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558533|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
558534|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558535|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558536|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558537|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558538|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558539|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558540|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
558541|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558542|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558543|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558544|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558545|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558546|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558547|NCT00877032|E7|Reported Event|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
558548|NCT00877032|E6|Reported Event|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
558549|NCT00877032|E5|Reported Event|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
558550|NCT00877032|E4|Reported Event|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
558551|NCT00877032|E3|Reported Event|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
558552|NCT00877032|E2|Reported Event|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
558553|NCT00877032|E1|Reported Event|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
558554|NCT00877058|B4|Baseline|Total|Total of all reporting groups
558555|NCT00877058|B3|Baseline|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
558556|NCT00877058|B2|Baseline|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
558557|NCT00877058|B1|Baseline|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
558558|NCT00877058|P3|Participant Flow|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
558559|NCT00877058|P2|Participant Flow|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings. http://www.vardalinstitutet.net/livslots.pdf.
558560|NCT00877058|P1|Participant Flow|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
558561|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
558562|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
558563|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
558564|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
558565|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
558566|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
558640|NCT00877487|P2|Participant Flow|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
558641|NCT00877487|P1|Participant Flow|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
565934|NCT00900627|B7|Baseline|Total|Total of all reporting groups
558567|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
558568|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
558569|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
558570|NCT00877058|E3|Reported Event|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
558571|NCT00877058|E2|Reported Event|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
558572|NCT00877058|E1|Reported Event|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
558573|NCT00877071|B1|Baseline|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility
LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
558574|NCT00877071|P1|Participant Flow|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility
LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
558575|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility
LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
558576|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility
LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
558642|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
558643|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
558644|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
558645|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
558577|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility
LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
558578|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility
LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
558579|NCT00877071|E1|Reported Event|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility
LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
558580|NCT00877370|B1|Baseline|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD
ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
558581|NCT00877370|P1|Participant Flow|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD
ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
558582|NCT00877370|O1|Outcome|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD
ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
558583|NCT00877370|E1|Reported Event|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD
ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
558584|NCT00877383|B3|Baseline|Total|Total of all reporting groups
558585|NCT00877383|B2|Baseline|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558586|NCT00877383|B1|Baseline|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558587|NCT00877383|P2|Participant Flow|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558646|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
558647|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
558648|NCT00877487|E2|Reported Event|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
558588|NCT00877383|P1|Participant Flow|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558589|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558590|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558591|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558592|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558593|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558594|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558595|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558596|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558597|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558598|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558599|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558600|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
566584|NCT00903630|B2|Baseline|Phase 1 - Dose Level 2|
558601|NCT00877383|E2|Reported Event|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558602|NCT00877383|E1|Reported Event|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
558603|NCT00877448|B8|Baseline|Total|Total of all reporting groups
558604|NCT00877448|B7|Baseline|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
558605|NCT00877448|B6|Baseline|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
558606|NCT00877448|B5|Baseline|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
558607|NCT00877448|B4|Baseline|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
558608|NCT00877448|B3|Baseline|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
558609|NCT00877448|B2|Baseline|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
558610|NCT00877448|B1|Baseline|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
558611|NCT00877448|P7|Participant Flow|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
558612|NCT00877448|P6|Participant Flow|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
558613|NCT00877448|P5|Participant Flow|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
558614|NCT00877448|P4|Participant Flow|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
558615|NCT00877448|P3|Participant Flow|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
558616|NCT00877448|P2|Participant Flow|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
558617|NCT00877448|P1|Participant Flow|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution (PBS) injected twice with the interval of 21 days between them.
558618|NCT00877448|O7|Outcome|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
558619|NCT00877448|O6|Outcome|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
558620|NCT00877448|O5|Outcome|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
558621|NCT00877448|O4|Outcome|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
558622|NCT00877448|O3|Outcome|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
558623|NCT00877448|O2|Outcome|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
558624|NCT00877448|O1|Outcome|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
558625|NCT00877448|O7|Outcome|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
558626|NCT00877448|O6|Outcome|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
558627|NCT00877448|O5|Outcome|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
558628|NCT00877448|O4|Outcome|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
558629|NCT00877448|O3|Outcome|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
558630|NCT00877448|O2|Outcome|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
558631|NCT00877448|O1|Outcome|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
558632|NCT00877448|E7|Reported Event|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
558633|NCT00877448|E6|Reported Event|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
558634|NCT00877448|E5|Reported Event|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
558635|NCT00877448|E4|Reported Event|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
558636|NCT00877448|E3|Reported Event|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
558637|NCT00877448|E2|Reported Event|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
558638|NCT00877448|E1|Reported Event|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
558639|NCT00877487|B1|Baseline|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
566585|NCT00903630|B1|Baseline|Phase 1 - Dose Level 1|
558651|NCT00877604|B2|Baseline|Placebo|"excipient lactose
Placebo: identical placebo by oral route at the same dosing schedule"
558652|NCT00877604|B1|Baseline|TUDCA|"tauroursodeoxycholic acid di-hydrate
tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
558653|NCT00877604|P2|Participant Flow|Placebo|"excipient lactose
Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
558654|NCT00877604|P1|Participant Flow|TUDCA|"tauroursodeoxycholic acid di-hydrate
tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
558655|NCT00877604|O2|Outcome|Placebo|"excipient lactose
Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
558656|NCT00877604|O1|Outcome|TUDCA|"tauroursodeoxycholic acid di-hydrate
tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
558657|NCT00877604|E2|Reported Event|Placebo|"excipient lactose
Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
558658|NCT00877604|E1|Reported Event|TUDCA|"tauroursodeoxycholic acid di-hydrate
tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
558659|NCT00877773|B1|Baseline|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
558660|NCT00877773|P1|Participant Flow|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
558661|NCT00877773|O1|Outcome|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
558662|NCT00877773|E1|Reported Event|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
558663|NCT00877799|B6|Baseline|Total|Total of all reporting groups
558664|NCT00877799|B5|Baseline|Cohort 2: CR845 0.040 mg/kg|CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours post-surgery (Day 0)
558665|NCT00877799|B4|Baseline|Cohort 2: Placebo|Matched placebo administered within 3 hours post-surgery (Day 0)
558666|NCT00877799|B3|Baseline|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
558667|NCT00877799|B2|Baseline|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
558668|NCT00877799|B1|Baseline|Cohort 1: Placebo|Matched placebo administered 24 hours post-surgery (Day 1)
558669|NCT00877799|P5|Participant Flow|Cohort 2: CR845 0.040 mg/kg|CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours after surgery (Day 0)
558670|NCT00877799|P4|Participant Flow|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery (Day 0)
558671|NCT00877799|P3|Participant Flow|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
558672|NCT00877799|P2|Participant Flow|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
558673|NCT00877799|P1|Participant Flow|Cohort 1: Placebo|Matched Placebo administered 24 hours post-surgery (Day 1)
558674|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
558675|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
558676|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
558677|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
558678|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
558679|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
558680|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|Cohort 2: CR845 (0.040 mg/kg) administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
558681|NCT00877799|O1|Outcome|Cohort 2: Placebo|Cohort 2: Matched Placebo administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
558682|NCT00877799|E5|Reported Event|Cohort 2: CR845 0.040 mg/kg|Cohort 2: CR845 (0.040 mg/kg) administered within 3 hours after surgery (Day 0)
558683|NCT00877799|E4|Reported Event|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery (Day 0)
558684|NCT00877799|E3|Reported Event|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) administered 24 hours after surgery (Day 1)
558685|NCT00877799|E2|Reported Event|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) administered 24 hours after surgery (Day 1)
558686|NCT00877799|E1|Reported Event|Cohort 1: Placebo|Matched placebo administered 24 hours after surgery (Day 1)
558687|NCT00877877|B1|Baseline|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558688|NCT00877877|P1|Participant Flow|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558689|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558690|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558691|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558692|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558693|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558694|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558695|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558696|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558697|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558698|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558699|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558700|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558701|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558702|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558703|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558704|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558705|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558706|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
558707|NCT00877877|E6|Reported Event|Cervarix Group From Month 108 to Month 120|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 108 until Month 120.
558708|NCT00877877|E5|Reported Event|Cervarix Group From Month 96 to Month 108|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 96 until Month 108.
558709|NCT00877877|E4|Reported Event|Cervarix Group From Month 84 to Month 96|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 84 until Month 96.
558710|NCT00877877|E3|Reported Event|Cervarix Group From Month 72 to Month 84|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 72 until Month 84.
558711|NCT00877877|E2|Reported Event|Cervarix Group From Month 60 Until Month 72|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 60 until Month 72.
558712|NCT00877877|E1|Reported Event|Cervarix Group From Month 48 Until Month 60|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 48 until Month 60.
558713|NCT00877890|B3|Baseline|Total|Total of all reporting groups
558714|NCT00877890|B2|Baseline|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558715|NCT00877890|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558716|NCT00877890|P2|Participant Flow|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558717|NCT00877890|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558718|NCT00877890|O4|Outcome|Exenatide Twice Daily No SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
558719|NCT00877890|O3|Outcome|Exenatide Once Weekly No SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
558720|NCT00877890|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening
558721|NCT00877890|O1|Outcome|Exenatide Once Weekly With SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening
558722|NCT00877890|O4|Outcome|Exenatide Twice Daily No SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
558723|NCT00877890|O3|Outcome|Exenatide Once Weekly No SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
558724|NCT00877890|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening
558725|NCT00877890|O1|Outcome|Exenatide Once Weekly With SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening
558726|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558727|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558728|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558729|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558730|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558731|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558732|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558733|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558734|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558735|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558736|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558737|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558738|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558739|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558740|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558741|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558742|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558743|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558744|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558745|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558746|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558747|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558748|NCT00877890|E2|Reported Event|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
558749|NCT00877890|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
558750|NCT00877929|B3|Baseline|Total|Total of all reporting groups
558751|NCT00877929|B2|Baseline|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558752|NCT00877929|B1|Baseline|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558753|NCT00877929|P2|Participant Flow|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558754|NCT00877929|P1|Participant Flow|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558755|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558756|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558757|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558758|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558759|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558760|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558761|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558762|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558763|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558764|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558765|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558766|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558767|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558768|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558769|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558770|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558771|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558772|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558773|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558774|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558775|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558776|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558777|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558778|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558779|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558780|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558781|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558782|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558783|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558784|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558785|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558786|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558787|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558788|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558789|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558790|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558791|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558792|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558793|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558794|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558795|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558796|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558797|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558798|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558799|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558800|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558801|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558802|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558803|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558804|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558805|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558806|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558807|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558808|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558809|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558810|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558811|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558812|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558813|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558814|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558815|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558816|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558817|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558818|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558819|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558820|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558821|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558822|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558823|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558824|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558825|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558826|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558827|NCT00877929|O2|Outcome|Amlodipine 5 mg|
558828|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|
558829|NCT00877929|O2|Outcome|Amlodipine 5 mg|
558830|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|
558831|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558832|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558833|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
572604|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
558834|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558835|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558836|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558837|NCT00877929|E2|Reported Event|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
558838|NCT00877929|E1|Reported Event|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
558839|NCT00878501|B4|Baseline|Total|Total of all reporting groups
558840|NCT00878501|B3|Baseline|Placebo Control|Placebo bid for 4 weeks
558841|NCT00878501|B2|Baseline|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
558842|NCT00878501|B1|Baseline|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
558843|NCT00878501|P3|Participant Flow|Placebo Control|Placebo bid for 4 weeks
558844|NCT00878501|P2|Participant Flow|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
558845|NCT00878501|P1|Participant Flow|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
558846|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
558847|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
558848|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
558849|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
558850|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
558851|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
558852|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
558853|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
558854|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
558855|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
558856|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
558857|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
558858|NCT00878501|E3|Reported Event|Placebo Control|Placebo bid for 4 weeks
558859|NCT00878501|E2|Reported Event|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
558860|NCT00878501|E1|Reported Event|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
558861|NCT00878553|B5|Baseline|Total|Total of all reporting groups
558862|NCT00878553|B4|Baseline|Sequence 4|15mg SKP-1041, 10mg SKP-1041, 20mg SKP-1041, Placebo
558863|NCT00878553|B3|Baseline|Sequence 3|20mg SKP-1041, Placebo, 15mg SKP-1041, 10mg SKP-1041
558864|NCT00878553|B2|Baseline|Sequence 2|Placebo, 10mg SKP-1041, 20mg SKP-1041, 15mg SKP-1041
558865|NCT00878553|B1|Baseline|Sequence 1|10mg SKP-1041, 15mg SKP-1041, Placebo, 20mg SKP-1041
558866|NCT00878553|P5|Participant Flow|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558867|NCT00878553|P4|Participant Flow|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558868|NCT00878553|P3|Participant Flow|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558869|NCT00878553|P2|Participant Flow|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment. Two placebo tablets were administered orally at bedtime for two consecutive nights during the Sleep Study, after which patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned for the next treatment in their randomized sequence.
558870|NCT00878553|P1|Participant Flow|Baseline: All Randomized Patients|"The second screening visit consisted of 2 consecutive sleep laboratory nights of placebo pretreatment and full PSG recordings. The 67 patients who met entry criteria were then randomized to four treatment sequences with their screening night mean PSG parameters defined as their baseline.
This trial was comprised of 2 study periods: Sleep and Pharmacokinetic (PK). Each of 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence for the Sleep Study. For each of these treatment arms, two double-dummy tablets were administered at bedtime for two consecutive nights. An additional (third) dosing night allowed for pharmacokinetic characterization of the investigational zaleplon formulation. In this PK Substudy, patient's plasma concentrations were measured after a single dose in parallel group design."
558871|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558872|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558873|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558874|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558875|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558876|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558877|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558878|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558879|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558880|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558881|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558882|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558883|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558884|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558885|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558886|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558887|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
558888|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
559996|NCT00875212|O2|Outcome|Calcium Glycerophosphate|intervention of using a CaGP dentifrice
558889|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558890|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558891|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10 mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558892|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558893|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558894|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558895|NCT00878553|O2|Outcome|10 mg SKP=1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558896|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558897|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558898|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558899|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558900|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558901|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558944|NCT00878722|B7|Baseline|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558947|NCT00878722|B4|Baseline|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
572605|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
558902|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558903|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558904|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558905|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558906|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558907|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558908|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558909|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558910|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558911|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558912|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558913|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558914|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558945|NCT00878722|B6|Baseline|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558946|NCT00878722|B5|Baseline|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
558915|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558916|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558917|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558918|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558919|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558920|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
558921|NCT00878553|E4|Reported Event|20mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
558922|NCT00878553|E3|Reported Event|15mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
558923|NCT00878553|E2|Reported Event|10 mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
558924|NCT00878553|E1|Reported Event|Placebo|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
558925|NCT00878605|B5|Baseline|Total|Total of all reporting groups
558926|NCT00878605|B4|Baseline|Cyclo-Z Gel 15mg + 20 mg Zinc|"Active medication high dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
558927|NCT00878605|B3|Baseline|Cyclo-Z Gel 9mg + 20 mg Zinc|"Active medication efficacy dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
558928|NCT00878605|B2|Baseline|Cyclo-Z Gel 3mg + 20 mg Zinc|"Active medication
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
558929|NCT00878605|B1|Baseline|Placebo|"Placebo control
Placebo: Placebo control"
558930|NCT00878605|P4|Participant Flow|Arm 4|"Active medication high dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
Participants received Cyclo-Z gel 15mg + 20 mg zinc orally per day for 12 weeks."
558931|NCT00878605|P3|Participant Flow|Arm 3|"Active medication efficacy dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
Participants received Cyclo-Z gel 9mg + 20 mg zinc orally per day for 12 weeks."
558932|NCT00878605|P2|Participant Flow|Arm 2|"Active medication
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
Participants received Cyclo-Z gel 3mg + 20 mg zinc orally per day for 12 weeks."
558933|NCT00878605|P1|Participant Flow|Arm 1|"Placebo control
Placebo: Placebo control
Participants received placebo tablet orally daily for 12 weeks."
558934|NCT00878605|O4|Outcome|Cyclo-Z Gel 15mg + 20 mg Zinc|"Active medication high dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
558935|NCT00878605|O3|Outcome|Cyclo-Z Gel 9mg + 20 mg Zinc|"Active medication efficacy dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
558936|NCT00878605|O2|Outcome|Cyclo-Z Gel 3mg + 20 mg Zinc|"Active medication
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
558937|NCT00878605|O1|Outcome|Placebo|"Placebo control
Placebo: Placebo control"
558938|NCT00878605|E4|Reported Event|Arm 4|"Active medication high dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
558939|NCT00878605|E3|Reported Event|Arm 3|"Active medication efficacy dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
558940|NCT00878605|E2|Reported Event|Arm 2|"Active medication
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
558941|NCT00878605|E1|Reported Event|Arm 1|"Placebo control
Placebo: Placebo control"
558942|NCT00878722|B9|Baseline|Total|Total of all reporting groups
558943|NCT00878722|B8|Baseline|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558948|NCT00878722|B3|Baseline|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
558949|NCT00878722|B2|Baseline|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
558950|NCT00878722|B1|Baseline|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
558951|NCT00878722|P8|Participant Flow|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558952|NCT00878722|P7|Participant Flow|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558953|NCT00878722|P6|Participant Flow|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558954|NCT00878722|P5|Participant Flow|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
558955|NCT00878722|P4|Participant Flow|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
558956|NCT00878722|P3|Participant Flow|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
558957|NCT00878722|P2|Participant Flow|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
558958|NCT00878722|P1|Participant Flow|Arm A, Step 1|PXD101 (belinostat) 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
558959|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
558960|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
558961|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
558962|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
558963|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
558964|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
558965|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
558966|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
558967|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
558968|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558969|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558970|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558971|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
558972|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
558973|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
558974|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
558975|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
558976|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558977|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558978|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558979|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
558980|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
558981|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
558982|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
558983|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
558984|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558985|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558986|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558987|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
558988|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
558989|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
572606|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
558990|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
558991|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
558992|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558993|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558994|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
558995|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
558996|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
558997|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
558998|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
558999|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
559000|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559001|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559002|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559003|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
559004|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
559005|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
559006|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
559007|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
559008|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559009|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559010|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559011|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
559012|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
559013|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
559014|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
559015|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
559016|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559017|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559018|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559019|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
559020|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
559021|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
559022|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
559023|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
559024|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559025|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559072|NCT00878800|E4|Reported Event|Cohort 4: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559026|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559027|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
559028|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
559029|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
559030|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
559031|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
559032|NCT00878722|E8|Reported Event|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559033|NCT00878722|E7|Reported Event|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559034|NCT00878722|E6|Reported Event|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
559035|NCT00878722|E5|Reported Event|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
559036|NCT00878722|E4|Reported Event|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
559037|NCT00878722|E3|Reported Event|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
559038|NCT00878722|E2|Reported Event|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
559039|NCT00878722|E1|Reported Event|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
559040|NCT00878800|B6|Baseline|Total|Total of all reporting groups
559041|NCT00878800|B5|Baseline|MTD Expansion: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559042|NCT00878800|B4|Baseline|Cohort 4: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559043|NCT00878800|B3|Baseline|Cohort 3: BelDox IV (800/75)|PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
559044|NCT00878800|B2|Baseline|Cohort 2: BelDox IV (600/75)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
559045|NCT00878800|B1|Baseline|Cohort 1: BelDox IV (600/50)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
559046|NCT00878800|P5|Participant Flow|MTD Expansion: BelDox IV (1000/75)|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559047|NCT00878800|P4|Participant Flow|Cohort 4: BelDox IV (1000/75)|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559048|NCT00878800|P3|Participant Flow|Cohort 3: BelDox IV (800/75)|PXD101 and doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
559049|NCT00878800|P2|Participant Flow|Cohort 2: BelDox IV (600/75)|PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
559050|NCT00878800|P1|Participant Flow|Cohort 1: BelDox IV (600/50)|PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
559051|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
559052|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
559053|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
559054|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
559055|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
559056|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
559057|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559058|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
559059|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559060|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
559061|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559062|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
559063|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559064|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
559065|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559066|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
559067|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559068|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
559069|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
559070|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
559071|NCT00878800|E5|Reported Event|MTD Expansion: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
559073|NCT00878800|E3|Reported Event|Cohort 3: BelDox IV (800/75)|PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
559074|NCT00878800|E2|Reported Event|Cohort 2: BelDox IV (600/75)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
559075|NCT00878800|E1|Reported Event|Cohort 1: BelDox IV (600/50)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
559076|NCT00878826|B4|Baseline|Total|Total of all reporting groups
559077|NCT00878826|B3|Baseline|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
559078|NCT00878826|B2|Baseline|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
559079|NCT00878826|B1|Baseline|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
559080|NCT00878826|P3|Participant Flow|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
559081|NCT00878826|P2|Participant Flow|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
559082|NCT00878826|P1|Participant Flow|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
559083|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
559084|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
559085|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
559086|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
559087|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
559088|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
559089|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
559090|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
559091|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
559092|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
559093|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
559094|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
559095|NCT00878826|E3|Reported Event|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
559096|NCT00878826|E2|Reported Event|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
559097|NCT00878826|E1|Reported Event|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
559098|NCT00878878|B3|Baseline|Total|Total of all reporting groups
559099|NCT00878878|B2|Baseline|Placebo Control First, Then Followed by Optison Product|Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
559100|NCT00878878|B1|Baseline|Optison First, Then Followed by Placebo Control|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
559101|NCT00878878|P2|Participant Flow|Placebo Control First, Then Followed by Optison Product|Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
559102|NCT00878878|P1|Participant Flow|Optison First, Then Followed by Placebo Control|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
559103|NCT00878878|O2|Outcome|Placebo Control (5% Dextrose) Given First, Then Optison|Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
559104|NCT00878878|O1|Outcome|Optison Given First, Then Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
559105|NCT00878878|O2|Outcome|Elevated Pulmonary Artery Systolic Pressure (PASP)|Observe subjects with elevated pulmonary artery systolic pressure (PASP)as measured by any adverse events. The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP).
559106|NCT00878878|O1|Outcome|Normal Pulmonary Artery Systolic Pressure (PASP)|Observe subjects with normal pulmonary artery systolic pressure (PASP)as measured by any adverse events. The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP).
559107|NCT00878878|O2|Outcome|Placebo Control (5% Dextrose) Given First, Then Optison|Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
559108|NCT00878878|O1|Outcome|Optison Given First, Then Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
559109|NCT00878878|E2|Reported Event|Placebo Control (5% Dextrose) First Followed by the Optison|Placebo Control (5% Dextrose) given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP. There was a 15 minute interval between the injections.
559110|NCT00878878|E1|Reported Event|Optison Product First Followed by Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
559111|NCT00878969|B4|Baseline|Total|Total of all reporting groups
559112|NCT00878969|B3|Baseline|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
559113|NCT00878969|B2|Baseline|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 6 mg of ramipril taken orally on a daily basis for 18 months
559114|NCT00878969|B1|Baseline|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
560025|NCT00881205|O2|Outcome|Placebo|Matching the size, shape and color of rivastigmine patches.
559115|NCT00878969|P3|Participant Flow|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
559116|NCT00878969|P2|Participant Flow|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
559117|NCT00878969|P1|Participant Flow|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
559118|NCT00878969|O3|Outcome|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
559119|NCT00878969|O2|Outcome|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
559120|NCT00878969|O1|Outcome|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
559121|NCT00878969|E3|Reported Event|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
559122|NCT00878969|E2|Reported Event|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
559123|NCT00878969|E1|Reported Event|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
559124|NCT00879034|B1|Baseline|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
559125|NCT00879034|P1|Participant Flow|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
559126|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
559127|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
559128|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
559129|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
559130|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
559168|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559169|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559131|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
559132|NCT00879034|E1|Reported Event|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
559133|NCT00879190|B3|Baseline|Total|Total of all reporting groups
559134|NCT00879190|B2|Baseline|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
559135|NCT00879190|B1|Baseline|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
559136|NCT00879190|P2|Participant Flow|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
559137|NCT00879190|P1|Participant Flow|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
559138|NCT00879190|O2|Outcome|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
559139|NCT00879190|O1|Outcome|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
559140|NCT00879190|O2|Outcome|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
559141|NCT00879190|O1|Outcome|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
559142|NCT00879190|O2|Outcome|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
559143|NCT00879190|O1|Outcome|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
559144|NCT00879190|E2|Reported Event|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
559145|NCT00879190|E1|Reported Event|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
559146|NCT00879229|B3|Baseline|Total|Total of all reporting groups
559147|NCT00879229|B2|Baseline|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559148|NCT00879229|B1|Baseline|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559149|NCT00879229|P2|Participant Flow|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559150|NCT00879229|P1|Participant Flow|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559151|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559152|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559153|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559154|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559155|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559156|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559157|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559158|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559159|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559160|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559161|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559162|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559163|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559164|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559165|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559166|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559167|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559170|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559171|NCT00879229|E2|Reported Event|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
559172|NCT00879229|E1|Reported Event|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
559173|NCT00879255|B3|Baseline|Total|Total of all reporting groups
559174|NCT00879255|B2|Baseline|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.
Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
559175|NCT00879255|B1|Baseline|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.
Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
559176|NCT00879255|P2|Participant Flow|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.
Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
559177|NCT00879255|P1|Participant Flow|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.
Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
559178|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.
Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
559179|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.
Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
559180|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.
Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
559181|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.
Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
559182|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.
Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
559183|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.
Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
559184|NCT00879255|E2|Reported Event|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.
Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
559204|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559185|NCT00879255|E1|Reported Event|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.
Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
559186|NCT00879333|B3|Baseline|Total|Total of all reporting groups
559187|NCT00879333|B2|Baseline|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559188|NCT00879333|B1|Baseline|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559189|NCT00879333|P2|Participant Flow|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559190|NCT00879333|P1|Participant Flow|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559191|NCT00879333|O2|Outcome|Everolimus 5mg/Day|Patients were randomized to receive everolimus + BSC. Patients orally took 5 mg tablet of everolimus once daily. One of the 11 patients on the 5 mg arm, only had a pre-dose evaluable sample.
559192|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559193|NCT00879333|O2|Outcome|Everolimus 5 mg/Day|Patients were randomized to receive everolimus + BSC. Patients orally took 1 5 mg tablet of everolimus once daily. Two of the 18 patients on the 5 mg arm, only had pre-dose evaluable samples.
559194|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559195|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559196|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559197|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559198|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559199|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559200|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559201|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559202|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559203|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
559205|NCT00879333|E2|Reported Event|Placebo|Placebo
559206|NCT00879333|E1|Reported Event|Everolimus 10mg / Daily|Everolimus 10mg / daily
559207|NCT00879359|B1|Baseline|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m^2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
559208|NCT00879359|P1|Participant Flow|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m^2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
559209|NCT00879359|O1|Outcome|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
559210|NCT00879359|O1|Outcome|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
559211|NCT00879359|O1|Outcome|Maintenance With Bevacizumab|carboplatin, paclitaxel, and bevacizumab: All patients enrolled will receive carboplatin AUC 5 plus paclitaxel 175 mg/m2 (135 mg/m2 if prior radiation to greater than 25% of bone marrow) plus bevacizumab 15 mg/kg every 3 weeks.
559212|NCT00879359|E1|Reported Event|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
559213|NCT00879398|B1|Baseline|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
559214|NCT00879398|P1|Participant Flow|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
559215|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
559216|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
559217|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
559218|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
559219|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
559220|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
559221|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
559222|NCT00879398|E1|Reported Event|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
559223|NCT00879411|B1|Baseline|Telmisartan, Hydrochlorothiazide|
559224|NCT00879411|P1|Participant Flow|Telmisartan, Hydrochlorothiazide|
559225|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
559226|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
559227|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
559228|NCT00879411|E1|Reported Event|Telmisartan, Hydrochlorothiazide|
559229|NCT00879619|B1|Baseline|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
prednisone : Given PO
docetaxel : Given IV
sunitinib malate : Given PO"
559230|NCT00879619|P1|Participant Flow|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO once daily (QD) on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
prednisone : Given PO
docetaxel : Given IV
sunitinib malate : Given PO"
559231|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
prednisone : Given PO
docetaxel : Given IV
sunitinib malate : Given PO"
559263|NCT00879684|B1|Baseline|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2, administered once-weekly in a 4-week cycle.
561205|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
559232|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
prednisone : Given PO
docetaxel : Given IV
sunitinib malate : Given PO"
559233|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
prednisone : Given PO
docetaxel : Given IV
sunitinib malate : Given PO"
559234|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
prednisone : Given PO
docetaxel : Given IV
sunitinib malate : Given PO"
559235|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
prednisone : Given PO
docetaxel : Given IV
sunitinib malate : Given PO"
559236|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
prednisone : Given PO
docetaxel : Given IV
sunitinib malate : Given PO"
559237|NCT00879619|E1|Reported Event|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
prednisone : Given PO
docetaxel : Given IV
sunitinib malate : Given PO"
559238|NCT00879645|B5|Baseline|Total|Total of all reporting groups
559239|NCT00879645|B4|Baseline|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
559240|NCT00879645|B3|Baseline|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
559241|NCT00879645|B2|Baseline|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
559242|NCT00879645|B1|Baseline|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
559243|NCT00879645|P4|Participant Flow|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
559244|NCT00879645|P3|Participant Flow|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
559245|NCT00879645|P2|Participant Flow|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
559246|NCT00879645|P1|Participant Flow|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
559247|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
559248|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
559249|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
559250|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
559251|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
559252|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
559253|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
559254|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
559255|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
559256|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
559257|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
559258|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
559259|NCT00879645|E4|Reported Event|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
559260|NCT00879645|E3|Reported Event|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
559261|NCT00879645|E2|Reported Event|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
559262|NCT00879645|E1|Reported Event|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
559298|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559264|NCT00879684|P7|Participant Flow|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
559265|NCT00879684|P6|Participant Flow|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559266|NCT00879684|P5|Participant Flow|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559267|NCT00879684|P4|Participant Flow|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559268|NCT00879684|P3|Participant Flow|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559269|NCT00879684|P2|Participant Flow|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559270|NCT00879684|P1|Participant Flow|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559271|NCT00879684|O7|Outcome|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
559272|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559273|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559274|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559275|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559276|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559277|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559278|NCT00879684|O1|Outcome|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2 administered once-weekly in a 4-week cycle.
559279|NCT00879684|O1|Outcome|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2 administered once-weekly in a 4-week cycle.
559280|NCT00879684|O1|Outcome|CVX-060 (Stage 1)|All participants who received 0.3, 1, 3, 6, 12, 15 mg/kg intravenous infusion once-weekly in Stage 1. Participants who discontinued treatment at any time were followed for 6 weeks to assess toxicity, pharmacokinetics (elimination half-life), and immunogenicity.
559281|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
559282|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559283|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559284|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559285|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559286|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559287|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
559288|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559289|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559290|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559291|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559292|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559293|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
559294|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559295|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559296|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559297|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
561206|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
559299|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
559300|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559301|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559302|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559303|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559304|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559305|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
559306|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559307|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559308|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559309|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559310|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559311|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
559312|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559313|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559314|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559315|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559316|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559317|NCT00879684|O7|Outcome|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
559318|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559319|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559320|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559321|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559322|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559323|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559324|NCT00879684|E7|Reported Event|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
559325|NCT00879684|E6|Reported Event|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559326|NCT00879684|E5|Reported Event|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559327|NCT00879684|E4|Reported Event|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559328|NCT00879684|E3|Reported Event|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559329|NCT00879684|E2|Reported Event|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559330|NCT00879684|E1|Reported Event|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
559331|NCT00879697|B3|Baseline|Total|Total of all reporting groups
559332|NCT00879697|B2|Baseline|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
559387|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559388|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559333|NCT00879697|B1|Baseline|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
559334|NCT00879697|P2|Participant Flow|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds (s) of each exercise bout.
559335|NCT00879697|P1|Participant Flow|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
559336|NCT00879697|O2|Outcome|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
559337|NCT00879697|O1|Outcome|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
559338|NCT00879697|E2|Reported Event|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
559339|NCT00879697|E1|Reported Event|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
559340|NCT00879710|B3|Baseline|Total|Total of all reporting groups
559341|NCT00879710|B2|Baseline|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,
4 weeks washout period
Ezetimibe 10 mg by month for 6 weeks
simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
559342|NCT00879710|B1|Baseline|Subjects With Type 1 Diabetes Mellitus,|"Simvastatin 40 mg tablet by month daily for 6 weeks,
4 weeks washout period
Ezetimibe 10 mg by month for 6 weeks
simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
559343|NCT00879710|P4|Participant Flow|Subjects With Type 2 Diabetes mellitus_Ezet_Simva|"Patients with T2DM were treated only with oral sulfonylurea drugs and/or biguanides and/or thiazolidinediones. Subjects with T2DM were excluded if they were on insulin or other injectable agents. All subjects were interviewed by S.K. to ensure classifications of T1DM and T2DM were accurate by history.
This group started with ezetimibe for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of simvastatin."
559344|NCT00879710|P3|Participant Flow|Subjects With Type 1 Diabetes mellitus_Ezet_Simva|"Subjects with T1DM were ascertained based on ketosis at the time of diagnosis and/or being treated with insulin since the diagnosis.
All subjects were interviewed by S.K. (a board certified endocrinologist) to ensure classifications of T1DM and T2DM were accurate by history and physical exam.
This group started with ezetimibe for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of simvastatin."
559345|NCT00879710|P2|Participant Flow|Subjects With Type 2 Diabetes mellitus_Simva_Ezet|"Patients with T2DM were treated only with oral sulfonylurea drugs and/or biguanides and/or thiazolidinediones. Subjects with T2DM were excluded if they were on insulin or other injectable agents. All subjects were interviewed by S.K. to ensure classifications of T1DM and T2DM were accurate by history.
This group started with simvastatin for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of ezetimibe."
559346|NCT00879710|P1|Participant Flow|Subjects With Type 1 Diabetes mellitus_Simva_Ezet|"Subjects with T1DM were ascertained based on ketosis at the time of diagnosis and/or being treated with insulin since the diagnosis.
All subjects were interviewed by S.K. (a board certified endocrinologist) to ensure classifications of T1DM and T2DM were accurate by history and physical exam.
This group started with simvastatin for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of ezetimibe."
559347|NCT00879710|O2|Outcome|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,
4 weeks washout period
Ezetimibe 10 mg by month for 6 weeks
simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
559389|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559390|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559391|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559392|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559348|NCT00879710|O1|Outcome|Subjects With Type 1 Diabetes Mellitus,|"Simvastatin 40 mg tablet by month daily for 6 weeks,
4 weeks washout period
Ezetimibe 10 mg by month for 6 weeks
simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
559349|NCT00879710|E4|Reported Event|Subjects With Type 2 Diabetes mellitus_Ezet_Simva|"Ezetimibe 10 mg tablet by month daily for 6 weeks,
4 weeks washout period
Simvastatin 40 mg by month for 6 weeks
simvastatin: Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
559350|NCT00879710|E3|Reported Event|Subjects With Type 1 Diabetes mellitus_Ezet_Simva|"Ezetimibe 10 mg tablet by month daily for 6 weeks,
4 weeks washout period
Simvastatin 40 mg by month for 6 weeks
simvastatin: Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
559351|NCT00879710|E2|Reported Event|Subjects With Type 2 Diabetes mellitus_Simva_Ezet|"Simvastatin 40 mg tablet by month daily for 6 weeks,
4 weeks washout period
Ezetimibe 10 mg by month for 6 weeks
simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
559352|NCT00879710|E1|Reported Event|Subjects With Type 1 Diabetes mellitus_Simva_Ezet|"Simvastatin 40 mg tablet by month daily for 6 weeks,
4 weeks washout period
Ezetimibe 10 mg by month for 6 weeks
simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
559353|NCT00879775|B3|Baseline|Total|Total of all reporting groups
559354|NCT00879775|B2|Baseline|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
559355|NCT00879775|B1|Baseline|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
559356|NCT00879775|P2|Participant Flow|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
559357|NCT00879775|P1|Participant Flow|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
559358|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
559359|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
559360|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
559361|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
559362|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
559363|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
559364|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
559365|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
559366|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
559367|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
559368|NCT00879775|E2|Reported Event|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
559369|NCT00879775|E1|Reported Event|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
559370|NCT00879814|B5|Baseline|Total|Total of all reporting groups
559371|NCT00879814|B4|Baseline|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559372|NCT00879814|B3|Baseline|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559373|NCT00879814|B2|Baseline|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559374|NCT00879814|B1|Baseline|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559375|NCT00879814|P4|Participant Flow|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559376|NCT00879814|P3|Participant Flow|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559377|NCT00879814|P2|Participant Flow|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559378|NCT00879814|P1|Participant Flow|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559379|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559380|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559381|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559382|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559383|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559384|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559385|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559386|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
572607|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
559395|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559396|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559397|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559398|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559399|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559400|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559401|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559402|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559403|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559404|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559405|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559406|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559407|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559408|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559409|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559410|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559411|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559412|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559413|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559414|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559415|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559416|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559417|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559418|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559419|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559420|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559421|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559422|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559423|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559424|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559425|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559426|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559427|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559428|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559429|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559430|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559431|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559432|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559433|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559434|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559435|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559436|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559437|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559438|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559439|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559440|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559441|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559442|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559443|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559444|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559445|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559446|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559447|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559448|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559449|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559450|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559451|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559452|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559453|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559454|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559455|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559456|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559457|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559458|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559459|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559460|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559461|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559462|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
561207|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
559463|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559464|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559465|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559466|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559467|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559468|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559469|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559470|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559471|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559472|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559473|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559474|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559475|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559476|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559477|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559478|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559479|NCT00879814|E4|Reported Event|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
559480|NCT00879814|E3|Reported Event|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
559481|NCT00879814|E2|Reported Event|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
559482|NCT00879814|E1|Reported Event|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
559483|NCT00879879|B1|Baseline|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year
losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
559484|NCT00879879|P1|Participant Flow|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year
losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
559485|NCT00879879|O1|Outcome|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year
losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
559486|NCT00879879|E1|Reported Event|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year
losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
559487|NCT00879970|B4|Baseline|Total|Total of all reporting groups
559488|NCT00879970|B3|Baseline|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559489|NCT00879970|B2|Baseline|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559490|NCT00879970|B1|Baseline|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559491|NCT00879970|P5|Participant Flow|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
559492|NCT00879970|P4|Participant Flow|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
559493|NCT00879970|P3|Participant Flow|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559494|NCT00879970|P2|Participant Flow|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559495|NCT00879970|P1|Participant Flow|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559496|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559497|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559498|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559499|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559500|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559501|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559502|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559503|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559504|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559505|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559506|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559507|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559508|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559509|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559510|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559511|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559512|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559513|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559514|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559515|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559516|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559517|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559518|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
572608|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
559519|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559520|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559521|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559522|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559523|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559524|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559525|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559526|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559527|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559528|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559529|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559530|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559531|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559532|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559533|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559534|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559535|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559536|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559537|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559538|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559539|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559540|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559541|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559542|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559543|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559544|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559545|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559546|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559547|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559548|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559549|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559550|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559551|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559552|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559553|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559554|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559555|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559556|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
559557|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
559558|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559559|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559560|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559561|NCT00879970|O5|Outcome|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
559562|NCT00879970|O4|Outcome|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
559563|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559564|NCT00879970|O2|Outcome|Pioglitzaone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559565|NCT00879970|O1|Outcome|Placebo|PLACEBO Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559566|NCT00879970|O5|Outcome|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
559567|NCT00879970|O4|Outcome|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
559568|NCT00879970|O3|Outcome|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559569|NCT00879970|O2|Outcome|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559570|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559571|NCT00879970|E5|Reported Event|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
559572|NCT00879970|E4|Reported Event|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days
559573|NCT00879970|E3|Reported Event|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
559574|NCT00879970|E2|Reported Event|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
559575|NCT00879970|E1|Reported Event|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
559576|NCT00879996|B3|Baseline|Total|Total of all reporting groups
559577|NCT00879996|B2|Baseline|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
559578|NCT00879996|B1|Baseline|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
559579|NCT00879996|P2|Participant Flow|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
559580|NCT00879996|P1|Participant Flow|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
559581|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
559582|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
559583|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
559584|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
559585|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
559586|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
559587|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day divided in 2-4 doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
559588|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day divided in 2-4 doses for 6 months
559589|NCT00879996|E2|Reported Event|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
559590|NCT00879996|E1|Reported Event|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
559591|NCT00880009|B1|Baseline|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559592|NCT00880009|P1|Participant Flow|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559593|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559594|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559595|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559596|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559597|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559598|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559599|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559600|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559601|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559602|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559603|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559604|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559605|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559606|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559607|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559608|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559609|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559610|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
572609|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
559611|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559612|NCT00880009|E1|Reported Event|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
559613|NCT00880022|B3|Baseline|Total|Total of all reporting groups
559614|NCT00880022|B2|Baseline|Arm, Trunck and Chest Compression|
559615|NCT00880022|B1|Baseline|Arm Compression Only|
559616|NCT00880022|P2|Participant Flow|Arm, Trunk and Chest Compression|Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
559617|NCT00880022|P1|Participant Flow|Arm Compression Only|Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
559618|NCT00880022|O2|Outcome|Arm, Trunck and Chest Compression|
559619|NCT00880022|O1|Outcome|Arm Compression Only|
559620|NCT00880022|E2|Reported Event|Arm, Trunck and Chest Compression|
559621|NCT00880022|E1|Reported Event|Arm Compression Only|
559622|NCT00880100|B1|Baseline|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
559623|NCT00880100|P1|Participant Flow|Ultrase® MT12|Patients received usual pancreatic enzymes therapy for 9 to 14 days during baseline phase followed by Ultrase® MT12 capsules orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
559624|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
559625|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
559626|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
559627|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
559628|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
559629|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
559630|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
559631|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
559632|NCT00880100|E1|Reported Event|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
559633|NCT00880165|B3|Baseline|Total|Total of all reporting groups
559634|NCT00880165|B2|Baseline|Arm 2|"Home unattended testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
559635|NCT00880165|B1|Baseline|Arm 1|"In-laboratory testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
559636|NCT00880165|P2|Participant Flow|Home Unattended Testing|"Home unattended testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment."
559637|NCT00880165|P1|Participant Flow|In-laboratory Testing|"In-laboratory testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment."
559638|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
559639|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
559640|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
559641|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
559642|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
559643|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
559644|NCT00880165|E2|Reported Event|Arm 2|"Home unattended testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
559645|NCT00880165|E1|Reported Event|Arm 1|"In-laboratory testing
Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
559646|NCT00880191|B3|Baseline|Total|Total of all reporting groups
559647|NCT00880191|B2|Baseline|Placebo|Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy. > dexamethasone: Given orally > placebo: Given orally
559648|NCT00880191|B1|Baseline|Gabapentin|Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy. > dexamethasone: Given orally > gabapentin: Given orally
559649|NCT00880191|P2|Participant Flow|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> placebo: Given orally"
559650|NCT00880191|P1|Participant Flow|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> gabapentin: Given orally"
559651|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> placebo: Given orally"
559652|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> gabapentin: Given orally"
559653|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> placebo: Given orally"
559654|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> gabapentin: Given orally"
559655|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> placebo: Given orally"
559656|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> gabapentin: Given orally"
559657|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> placebo: Given orally"
559658|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> gabapentin: Given orally"
559659|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> placebo: Given orally"
559660|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> gabapentin: Given orally"
559661|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> placebo: Given orally"
559662|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> gabapentin: Given orally"
559663|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> placebo: Given orally"
559664|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
> dexamethasone: Given orally
> gabapentin: Given orally"
559665|NCT00880191|E2|Reported Event|Placebo|placebo: Given orally
559666|NCT00880191|E1|Reported Event|Gabapentin|gabapentin: Given orally
559667|NCT00880230|B1|Baseline|Scuba Iliac Stent System|"Device: Scuba™ Iliac stent
Scuba Iliac Stent System: The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559668|NCT00880230|P1|Participant Flow|Scuba Iliac Stent System|"Device: Scuba Iliac Stent
Scuba Iliac Stent System: The Scuba Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559669|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559670|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559671|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559672|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559673|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559674|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559675|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559676|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559677|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559678|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559679|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559680|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559681|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559682|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559683|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559684|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559685|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559686|NCT00880230|E1|Reported Event|Scuba Iliac Stent System|"Device: Scuba™ iliac stent
Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
559687|NCT00880256|B1|Baseline|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
559688|NCT00880256|P1|Participant Flow|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
559689|NCT00880256|O1|Outcome|Mindfulness-Based Stress Reduction (MBSR)|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
559690|NCT00880256|O1|Outcome|Mindfulness-Based Stress Reduction (MBSR)|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
559691|NCT00880256|E1|Reported Event|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
559692|NCT00880269|B3|Baseline|Total|Total of all reporting groups
559693|NCT00880269|B2|Baseline|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
572610|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
559694|NCT00880269|B1|Baseline|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
559695|NCT00880269|P2|Participant Flow|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
559696|NCT00880269|P1|Participant Flow|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
559697|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
559698|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
559699|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
559700|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
559701|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
559702|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
559703|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
559704|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
559705|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
559706|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
559707|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
559708|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
559709|NCT00880269|E2|Reported Event|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
559710|NCT00880269|E1|Reported Event|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
559711|NCT00880334|B3|Baseline|Total|Total of all reporting groups
559712|NCT00880334|B2|Baseline|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
559713|NCT00880334|B1|Baseline|Vandetanib & Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
559714|NCT00880334|P2|Participant Flow|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
559715|NCT00880334|P1|Participant Flow|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
559716|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
559717|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
559718|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
559719|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
559720|NCT00880334|O2|Outcome|Placebo and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Placebo: Taken orally once a day every day"
559721|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Vandetanib: taken orally once a day, every day"
559722|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
559723|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
559724|NCT00880334|O2|Outcome|Placebo and Docetaxel|"Placebo orally and docetaxel intravenously
Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Placebo: Taken orally once a day every day"
559725|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Vandetanib: taken orally once a day, every day"
559726|NCT00880334|E2|Reported Event|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
559727|NCT00880334|E1|Reported Event|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
559728|NCT00880360|B1|Baseline|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
559729|NCT00880360|P1|Participant Flow|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
559730|NCT00880360|O1|Outcome|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
559731|NCT00880360|E1|Reported Event|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
559732|NCT00880425|B1|Baseline|Chronic Daily Headache|Patients who fulfilled criteria for Chronic Migraine, New Daily Persistent Headache , Chronic Post Traumatic Headache or Chronic Tension Type Headache
559733|NCT00880425|P2|Participant Flow|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
559734|NCT00880425|P1|Participant Flow|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
559735|NCT00880425|O2|Outcome|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
559736|NCT00880425|O1|Outcome|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
559737|NCT00880425|O2|Outcome|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
559738|NCT00880425|O1|Outcome|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
559739|NCT00880425|E2|Reported Event|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
559740|NCT00880425|E1|Reported Event|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
559741|NCT00880542|B1|Baseline|Sorafenib + Ifosfamide|
559742|NCT00880542|P1|Participant Flow|Sorafenib + Ifosfamide|
559743|NCT00880542|O1|Outcome|Sorafenib + Ifosfamide|
559744|NCT00880542|O1|Outcome|Sorafenib + Ifosfamide|
559745|NCT00880542|E1|Reported Event|Sorafenib + Ifosfamide|
559746|NCT00880555|B4|Baseline|Total|Total of all reporting groups
559747|NCT00880555|B3|Baseline|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
559748|NCT00880555|B2|Baseline|Arm 2: Control|Elderly controls without memory impairment
559749|NCT00880555|B1|Baseline|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
559750|NCT00880555|P6|Participant Flow|Non-AD Dementia|Other causes of dementia
559751|NCT00880555|P5|Participant Flow|Intoxicated|Individuals who appeared to be intoxicated at baseline evaluation
559752|NCT00880555|P4|Participant Flow|CIND|Individuals with cognitive impairment who did not meet criteria for MCI or dementia
559753|NCT00880555|P3|Participant Flow|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
559754|NCT00880555|P2|Participant Flow|Arm 2: Control|Elderly controls without memory impairment
559755|NCT00880555|P1|Participant Flow|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
559756|NCT00880555|O3|Outcome|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
559757|NCT00880555|O2|Outcome|Arm 2: Control|Elderly controls without memory impairment
559758|NCT00880555|O1|Outcome|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
559759|NCT00880555|E6|Reported Event|Non-AD Dementia|Other causes of dementia
559760|NCT00880555|E5|Reported Event|Intoxicated|Individuals who appeared to be intoxicated at baseline evaluation
559761|NCT00880555|E4|Reported Event|CIND|Individuals with cognitive impairment who did not meet criteria for MCI or dementia
559762|NCT00880555|E3|Reported Event|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
559763|NCT00880555|E2|Reported Event|Arm 2: Control|Elderly controls without memory impairment
559764|NCT00880555|E1|Reported Event|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
559765|NCT00880568|B10|Baseline|Total|Total of all reporting groups
559766|NCT00880568|B9|Baseline|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559767|NCT00880568|B8|Baseline|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559768|NCT00880568|B7|Baseline|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559769|NCT00880568|B6|Baseline|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559770|NCT00880568|B5|Baseline|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559771|NCT00880568|B4|Baseline|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
559772|NCT00880568|B3|Baseline|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
559773|NCT00880568|B2|Baseline|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
559774|NCT00880568|B1|Baseline|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
559775|NCT00880568|P9|Participant Flow|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559776|NCT00880568|P8|Participant Flow|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559777|NCT00880568|P7|Participant Flow|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559778|NCT00880568|P6|Participant Flow|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559779|NCT00880568|P5|Participant Flow|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559780|NCT00880568|P4|Participant Flow|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
559781|NCT00880568|P3|Participant Flow|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
559782|NCT00880568|P2|Participant Flow|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
559783|NCT00880568|P1|Participant Flow|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
559784|NCT00880568|O9|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559785|NCT00880568|O8|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559786|NCT00880568|O7|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559787|NCT00880568|O6|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559788|NCT00880568|O5|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559789|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
559790|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
559791|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
559792|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
559793|NCT00880568|O5|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559794|NCT00880568|O4|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559795|NCT00880568|O3|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559796|NCT00880568|O2|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559797|NCT00880568|O1|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559798|NCT00880568|O5|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559799|NCT00880568|O4|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559800|NCT00880568|O3|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559801|NCT00880568|O2|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559802|NCT00880568|O1|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559803|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
559804|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
559805|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
559806|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
559807|NCT00880568|O9|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559808|NCT00880568|O8|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559809|NCT00880568|O7|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559810|NCT00880568|O6|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559811|NCT00880568|O5|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559812|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
559813|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
559814|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
559815|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
559816|NCT00880568|E9|Reported Event|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559817|NCT00880568|E8|Reported Event|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559818|NCT00880568|E7|Reported Event|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559819|NCT00880568|E6|Reported Event|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559820|NCT00880568|E5|Reported Event|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
559821|NCT00880568|E4|Reported Event|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
559822|NCT00880568|E3|Reported Event|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
559823|NCT00880568|E2|Reported Event|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
559824|NCT00880568|E1|Reported Event|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
559825|NCT00880581|B1|Baseline|PF-3512676|To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma.
559826|NCT00880581|P1|Participant Flow|PF-3512676|To assess the feasibility of using intra-tumoral PF-3512676 (CpG 7909 or ProMune) at 18 mg per week over 10 weeks in combination with local radiation [2 gray (2Gy) on each of Days 1 and 2] as a therapy for low-grade B-cell lymphoma.
559827|NCT00880581|O1|Outcome|PF-3512676|"Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.
PF-3512676: 18 mg injection
Local radiotherapy: 2 x 2 Gy"
559828|NCT00880581|O1|Outcome|PF-3512676|"Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.
PF-3512676: 18 mg injection
Local radiotherapy: 2 x 2 Gy"
559829|NCT00880581|E1|Reported Event|PF-3512676|Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.
559830|NCT00880620|B5|Baseline|Total|Total of all reporting groups
559831|NCT00880620|B4|Baseline|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
559832|NCT00880620|B3|Baseline|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
559833|NCT00880620|B2|Baseline|IPX066 145 mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
559834|NCT00880620|B1|Baseline|Placebo|Placebo capsules were used
559835|NCT00880620|P4|Participant Flow|IPX066 390 mg LD|IPX066 capsules that contained 390 mg levodopa and 97.5 mg carbidopa
559836|NCT00880620|P3|Participant Flow|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
559837|NCT00880620|P2|Participant Flow|IPX066 145 mg LD|IPX066 capsule containing 145 mg levodopa and 36.25 mg carbidopa
559838|NCT00880620|P1|Participant Flow|Placebo|Placebo capsules were used
559839|NCT00880620|O4|Outcome|Placebo|Placebo capsules were used
559840|NCT00880620|O3|Outcome|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
559841|NCT00880620|O2|Outcome|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
559842|NCT00880620|O1|Outcome|IPX066 145 mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
559843|NCT00880620|O4|Outcome|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
559844|NCT00880620|O3|Outcome|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
559845|NCT00880620|O2|Outcome|IPX066 145mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
559846|NCT00880620|O1|Outcome|Placebo|Placebo capsules were used
559847|NCT00880620|E4|Reported Event|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
559848|NCT00880620|E3|Reported Event|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
559849|NCT00880620|E2|Reported Event|IPX066 145 mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
559850|NCT00880620|E1|Reported Event|Placebo|Placebo capsules were used
559851|NCT00880685|B1|Baseline|Memantine 10mg-30mg|10mg-30mg
559852|NCT00880685|P1|Participant Flow|Memantine 10mg-30mg|10mg-30mg
559853|NCT00880685|O1|Outcome|Memantine 10mg-30mg|10mg-30mg
559854|NCT00880685|O1|Outcome|Memantine|"Memantine 10-30mg
Memantine: 10-30mg, daily for 8 weeks"
559855|NCT00880685|O1|Outcome|Memantine 10mg-30mg|10mg-30mg
559856|NCT00880685|E3|Reported Event|Memantine 30mg|30mg
559857|NCT00880685|E2|Reported Event|Memantine 20mg|20mg
559858|NCT00880685|E1|Reported Event|Memantine 10mg|10mg
559859|NCT00880698|B5|Baseline|Total|Total of all reporting groups
559860|NCT00880698|B4|Baseline|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559861|NCT00880698|B3|Baseline|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559862|NCT00880698|B2|Baseline|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559863|NCT00880698|B1|Baseline|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559864|NCT00880698|P4|Participant Flow|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559865|NCT00880698|P3|Participant Flow|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559866|NCT00880698|P2|Participant Flow|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559867|NCT00880698|P1|Participant Flow|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559868|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559869|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559870|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559871|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559872|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559873|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559874|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559875|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559876|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559877|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559878|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559879|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559880|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559881|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559882|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559883|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559884|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559885|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559886|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
Placebo: 2 mL solution"
559887|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
559888|NCT00880698|E4|Reported Event|HIV-1 Infected Placebo|
559889|NCT00880698|E3|Reported Event|HIV-1 Infected RotaTeq|
559890|NCT00880698|E2|Reported Event|HIV-1 Uninfected Placebo|
559891|NCT00880698|E1|Reported Event|HIV-1 Uninfected RotaTeq|
559892|NCT00880750|B3|Baseline|Total|Total of all reporting groups
560026|NCT00881205|O1|Outcome|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
559893|NCT00880750|B2|Baseline|Lanthanum Carbonate Chewable Tablet First|Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
559894|NCT00880750|B1|Baseline|Lanthanum Carbonate Granules First|Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
559895|NCT00880750|P2|Participant Flow|Lanthanum Carbonate Chewable Tablet First|Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
559896|NCT00880750|P1|Participant Flow|Lanthanum Carbonate Granules First|Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
559897|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559898|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559899|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559900|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559901|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559902|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559903|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559904|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559905|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559906|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559907|NCT00880750|E2|Reported Event|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559908|NCT00880750|E1|Reported Event|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
559909|NCT00880763|B5|Baseline|Total|Total of all reporting groups
559910|NCT00880763|B4|Baseline|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559911|NCT00880763|B3|Baseline|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559912|NCT00880763|B2|Baseline|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559913|NCT00880763|B1|Baseline|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559914|NCT00880763|P4|Participant Flow|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559915|NCT00880763|P3|Participant Flow|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559916|NCT00880763|P2|Participant Flow|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559917|NCT00880763|P1|Participant Flow|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559918|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559919|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559920|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559921|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559922|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559923|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559924|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559925|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559926|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559927|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559928|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559929|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559930|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559931|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559932|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559933|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559934|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559935|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559936|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559937|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559938|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559939|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559940|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559941|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559942|NCT00880763|E4|Reported Event|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559943|NCT00880763|E3|Reported Event|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559944|NCT00880763|E2|Reported Event|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559945|NCT00880763|E1|Reported Event|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
559946|NCT00880906|B3|Baseline|Total|Total of all reporting groups
559947|NCT00880906|B2|Baseline|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
559948|NCT00880906|B1|Baseline|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.
Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
559949|NCT00880906|P2|Participant Flow|Group B Drug Therapy Only|Receives steroids and PPI only- Does not have esophageal dilation.
559950|NCT00880906|P1|Participant Flow|Group A Drug Therapy Plus Dilation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.
Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
559951|NCT00880906|O2|Outcome|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
559952|NCT00880906|O1|Outcome|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.
Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
559953|NCT00880906|E2|Reported Event|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
559954|NCT00880906|E1|Reported Event|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.
Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
559955|NCT00880919|B4|Baseline|Total|Total of all reporting groups
559956|NCT00880919|B3|Baseline|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
559957|NCT00880919|B2|Baseline|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
559958|NCT00880919|B1|Baseline|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
559959|NCT00880919|P3|Participant Flow|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
559960|NCT00880919|P2|Participant Flow|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
559961|NCT00880919|P1|Participant Flow|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
559962|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
559963|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
559964|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
559965|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
559966|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
559967|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
559968|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
559969|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
559970|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
559971|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
559972|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
559973|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
559974|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
559975|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
559976|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
559977|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
559978|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
559979|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
559980|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
559981|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
559982|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
559983|NCT00880919|O3|Outcome|Placebo (n=29)|"Equivalent number of placebo oral tablets taken daily for 8 weeks.
Placebo: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
559984|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33)|"Seroquel XR 300mg oral tablets taken daily for 8 weeks.
quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
559985|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33)|"Seroquel XR 150mg oral tablets taken daily for 8 weeks.
quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
559986|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
559987|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
559988|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
559989|NCT00880919|E3|Reported Event|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
559990|NCT00880919|E2|Reported Event|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
559991|NCT00880919|E1|Reported Event|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
559992|NCT00875212|B1|Baseline|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
559993|NCT00875212|P1|Participant Flow|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
559994|NCT00875212|O4|Outcome|Calcium Glycerophosphate and Fluoride|intervention of using a CaGP+Fluoride dentifrice
559997|NCT00875212|O1|Outcome|Control|use of a placebo dentifrice (no fluoride and no CaGP). The volunteers were asked to use the placebo dentifrices for more one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
559998|NCT00875212|O4|Outcome|Calcium Glycerophosphate and Fluoride|intervention of using a dentifrice containing fluoride and calcium glycerophosphate
559999|NCT00875212|O3|Outcome|Fluoride|intervention of using a dentifrice with 1,500 ppm of fluoride
560000|NCT00875212|O2|Outcome|Calcium Glycerophosphate|intervention of using a dentifrice containing only calcium glycerophosphate (CaGP)
560001|NCT00875212|O1|Outcome|Control|intervention of using a dentifrice of no active ingredient. The volunteers were asked to use the placebo dentifrices for one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
560002|NCT00875212|E1|Reported Event|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
560003|NCT00875329|B1|Baseline|Group 1|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
560004|NCT00875329|P1|Participant Flow|Convenience Sample|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder were included. This included all ages, both sexes, and all races and ethnicities. All participants provided responses to demographic information, a TBI Re-screen, and a semi-structured TBI Identification Clinical Interview.
560005|NCT00875329|O1|Outcome|Convenience Sample|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
560006|NCT00875329|E1|Reported Event|Convenience Sample|A convenience sample of 97 VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
560007|NCT00875394|B4|Baseline|Total|Total of all reporting groups
560008|NCT00875394|B3|Baseline|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
560009|NCT00875394|B2|Baseline|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
560010|NCT00875394|B1|Baseline|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
560011|NCT00875394|P3|Participant Flow|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
560012|NCT00875394|P2|Participant Flow|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
560013|NCT00875394|P1|Participant Flow|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
560014|NCT00875394|O3|Outcome|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
560015|NCT00875394|O2|Outcome|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
560016|NCT00875394|O1|Outcome|Sitagliptin + Metformin|Patients administered sitagliptin and metformin.
560017|NCT00875394|E3|Reported Event|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
560018|NCT00875394|E2|Reported Event|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
560019|NCT00875394|E1|Reported Event|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
560020|NCT00881205|B3|Baseline|Total|Total of all reporting groups
560021|NCT00881205|B2|Baseline|Placebo|Matching the size, shape and color of rivastigmine patches.
560022|NCT00881205|B1|Baseline|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
560023|NCT00881205|P2|Participant Flow|Placebo|Matching the size, shape and color of rivastigmine patches.
560024|NCT00881205|P1|Participant Flow|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
560027|NCT00881205|E3|Reported Event|Placebo|Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
560028|NCT00881205|E2|Reported Event|Rivastigmine|Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
560029|NCT00881205|E1|Reported Event|Total Patients|Total Patients
560030|NCT00882661|B4|Baseline|Total|Total of all reporting groups
560031|NCT00882661|B3|Baseline|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
560032|NCT00882661|B2|Baseline|ASSURE Cervical Plate and Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
560033|NCT00882661|B1|Baseline|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
560034|NCT00882661|P2|Participant Flow|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
560035|NCT00882661|P1|Participant Flow|SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
560036|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
560037|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
560038|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
560039|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
560040|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
560041|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
560042|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
560043|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
560044|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
560045|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
560046|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
560047|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
560048|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
560049|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
560050|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
560051|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
560052|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
560053|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
560054|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
560055|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
560056|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
560057|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
560058|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
560059|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
560060|NCT00882661|E2|Reported Event|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
560061|NCT00882661|E1|Reported Event|SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
560062|NCT00882687|B5|Baseline|Total|Total of all reporting groups
560063|NCT00882687|B4|Baseline|Placebo|
560064|NCT00882687|B3|Baseline|Lifitegrast 5.0%|
560065|NCT00882687|B2|Baseline|Lifitegrast 1.0%|
560066|NCT00882687|B1|Baseline|Lifitegrast 0.1%|
560067|NCT00882687|P4|Participant Flow|Placebo|
560068|NCT00882687|P3|Participant Flow|Lifitegrast 5.0%|
560069|NCT00882687|P2|Participant Flow|Lifitegrast 1.0%|
560070|NCT00882687|P1|Participant Flow|Lifitegrast 0.1%|
560071|NCT00882687|O4|Outcome|Placebo|
560099|NCT00882713|B1|Baseline|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560100|NCT00882713|P1|Participant Flow|C.E.R.A.|Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A.) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560101|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560102|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560103|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560104|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560105|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560106|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560107|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560108|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560109|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560110|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560111|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560112|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560113|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560342|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
561208|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
560114|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560115|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560116|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560117|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560118|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560119|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560120|NCT00882713|E1|Reported Event|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
560121|NCT00882778|B1|Baseline|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560122|NCT00882778|P1|Participant Flow|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560123|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560124|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560125|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560126|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560127|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560128|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560165|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560129|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560130|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560131|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560132|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560133|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560134|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560135|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560136|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560137|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560138|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560139|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560140|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560141|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560142|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560143|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560144|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560336|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560145|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560146|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560147|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560148|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560149|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560150|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560151|NCT00882778|E1|Reported Event|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
560152|NCT00882908|B6|Baseline|Total|Total of all reporting groups
560153|NCT00882908|B5|Baseline|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560154|NCT00882908|B4|Baseline|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560155|NCT00882908|B3|Baseline|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560156|NCT00882908|B2|Baseline|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560157|NCT00882908|B1|Baseline|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560158|NCT00882908|P5|Participant Flow|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560159|NCT00882908|P4|Participant Flow|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560160|NCT00882908|P3|Participant Flow|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560161|NCT00882908|P2|Participant Flow|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560162|NCT00882908|P1|Participant Flow|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560163|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560164|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560337|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560166|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560167|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560168|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560169|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560170|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560171|NCT00882908|O5|Outcome|All TMC435 Treatment Groups|Participants in all 4 TMC435 treatment groups combined.
560172|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560173|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560174|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560175|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560176|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560177|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560178|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560179|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560180|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560181|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560182|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560183|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560184|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560185|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560186|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560187|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560338|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560339|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560188|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560189|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560190|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560191|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560192|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560193|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560194|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560195|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560196|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560197|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560198|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560199|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560200|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560201|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560202|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560203|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560204|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560205|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560206|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560207|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560208|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560209|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560340|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
572611|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
560210|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560211|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560212|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560213|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560214|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560215|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560216|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560217|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560218|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560219|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560220|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560221|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560222|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560223|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560224|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560225|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560226|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560227|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560228|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560229|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560230|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560231|NCT00882908|E5|Reported Event|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
560232|NCT00882908|E4|Reported Event|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560233|NCT00882908|E3|Reported Event|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560234|NCT00882908|E2|Reported Event|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560235|NCT00882908|E1|Reported Event|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
560236|NCT00882921|B1|Baseline|Elaprase® (0.5 mg/kg)|
560237|NCT00882921|P1|Participant Flow|Elaprase® (0.5 mg/kg)|
560238|NCT00882921|O1|Outcome|Elaprase|"Idursulfase 0.5 mg/kg Weekly
Idursulfase: Patients will receive idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire or the HOS."
560239|NCT00882921|O1|Outcome|Idursulfase (Elaprase) 0.5 mg/kg Weekly|Idursulfase: Patients will receive idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire or the HOS.
560240|NCT00882921|E1|Reported Event|Elaprase® (0.5 mg/kg)|
560241|NCT00883090|B1|Baseline|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560242|NCT00883090|P1|Participant Flow|FXIII|All subjects treated with Factor XIII Concentrate (Human) (FXIII)
560243|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560244|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560245|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560246|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560247|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560248|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560249|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560250|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560251|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560252|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560253|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560254|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560255|NCT00883090|E1|Reported Event|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
560256|NCT00883103|B3|Baseline|Total|Total of all reporting groups
560257|NCT00883103|B2|Baseline|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
560258|NCT00883103|B1|Baseline|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
560259|NCT00883103|P2|Participant Flow|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
560260|NCT00883103|P1|Participant Flow|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
560261|NCT00883103|O2|Outcome|Aqueous Gel|Aqueous gel was applied to the Q-tip and the catheter before insertion.
560262|NCT00883103|O1|Outcome|Lidocaine|Lidocaine gel was applied to the Q-tip and the catheter before insertion.
560263|NCT00883103|E2|Reported Event|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
560264|NCT00883103|E1|Reported Event|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
560265|NCT00883116|B3|Baseline|Total|Total of all reporting groups
560266|NCT00883116|B2|Baseline|Control Chemotherapy|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
560267|NCT00883116|B1|Baseline|Ixabepilone, 40 mg/m^2, IV|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
560268|NCT00883116|P2|Participant Flow|Control Chemotherapy|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
560269|NCT00883116|P1|Participant Flow|Ixabepilone, 40 mg/m^2, IV|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
560270|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
560271|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
560272|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
560273|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
560274|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
560275|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
560276|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received paclitaxel, 175 mg/m^2, given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2, given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
560277|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
560278|NCT00883116|E3|Reported Event|Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)|Participants received paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity.
560279|NCT00883116|E2|Reported Event|Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)|Participants received doxorubicin, 60 mg/m^2 given intravenously (IV) per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
560280|NCT00883116|E1|Reported Event|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
560281|NCT00883129|B3|Baseline|Total|Total of all reporting groups
560282|NCT00883129|B2|Baseline|Cyclophosphamide Arm|"Participants will receive oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560283|NCT00883129|B1|Baseline|Mycophenolate Arm|"Participants will receive oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560284|NCT00883129|P2|Participant Flow|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560285|NCT00883129|P1|Participant Flow|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560286|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560287|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560288|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560289|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560290|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560291|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560292|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560293|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560341|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560294|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560295|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560296|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560297|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560298|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560299|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560300|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560301|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560302|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560303|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560304|NCT00883129|E2|Reported Event|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.
Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
560305|NCT00883129|E1|Reported Event|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.
Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
560306|NCT00883168|B5|Baseline|Total|Total of all reporting groups
560307|NCT00883168|B4|Baseline|Placebo|placebo nasal spray
560308|NCT00883168|B3|Baseline|Fluticasone Propionate|fluticasone propionate nasal spray
560309|NCT00883168|B2|Baseline|Azelastine Hcl|azelastine HCl nasal spray
560310|NCT00883168|B1|Baseline|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
560311|NCT00883168|P4|Participant Flow|Placebo|placebo nasal spray
560312|NCT00883168|P3|Participant Flow|Fluticasone Propionate|fluticasone propionate nasal spray
560313|NCT00883168|P2|Participant Flow|Azelastine Hcl|azelastine HCl nasal spray
560314|NCT00883168|P1|Participant Flow|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
560315|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
560316|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
560317|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
560318|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
560319|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
560320|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
560321|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
560322|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
560323|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
560324|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
560325|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
560326|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
560327|NCT00883168|E4|Reported Event|Placebo|placebo nasal spray
560328|NCT00883168|E3|Reported Event|Fluticasone Propionate|fluticasone propionate nasal spray
560329|NCT00883168|E2|Reported Event|Azelastine Hcl|azelastine HCl nasal spray
560330|NCT00883168|E1|Reported Event|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
560331|NCT00883181|B1|Baseline|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560332|NCT00883181|P1|Participant Flow|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560333|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560334|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560335|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560343|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560344|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560345|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560346|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560347|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560348|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560349|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560350|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560351|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560352|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560353|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560354|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560355|NCT00883181|O2|Outcome|No ESA Use|Participants who did not receive treatment with a erythropoiesis-stimulating agent (ESA) during cycles 1 to 8.
560356|NCT00883181|O1|Outcome|Any ESA Use|Participants who received treatment with any erythropoiesis-stimulating agent (ESA) during cycles 1 to 8.
560357|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560358|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560359|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
560360|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560361|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560362|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560363|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560364|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560365|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560366|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560367|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560368|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560369|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560370|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560371|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560372|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560373|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560374|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560375|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560376|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560377|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560378|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560379|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560380|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560381|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560382|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560383|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560384|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560385|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560386|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560387|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560388|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560389|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560390|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560391|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560392|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560393|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
572612|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
560394|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560395|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560396|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560397|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560398|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560399|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560400|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560401|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560402|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560403|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560404|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560405|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560406|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560407|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560408|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560409|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560410|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560411|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560412|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560413|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560414|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560415|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560416|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560417|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560418|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560419|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560420|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560421|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560422|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560423|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560424|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560425|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560426|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560427|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560428|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560429|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560430|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560431|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560432|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560433|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560434|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560435|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560436|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560437|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560438|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560439|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560440|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560441|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560442|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560443|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560444|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560445|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560446|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
572613|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
560447|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560448|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560449|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560450|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560451|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560452|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560453|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560454|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560455|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560456|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560457|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560458|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560459|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560460|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560461|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560462|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560463|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560464|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560465|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560466|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560467|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560468|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560469|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560470|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560471|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560472|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560473|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560474|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560475|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560476|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560477|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560478|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560479|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560480|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560481|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560482|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560483|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560484|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560485|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560486|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560487|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560488|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560489|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560490|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560491|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560492|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560493|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560494|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560495|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560496|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560497|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560498|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560499|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
572614|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
560500|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560501|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560502|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560503|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560504|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560505|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560506|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560507|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560508|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560509|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560510|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560511|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560512|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560513|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560514|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560515|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560516|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560517|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560518|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560519|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560520|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560521|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560522|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560523|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560524|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560525|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560526|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560527|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560528|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
560529|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
560530|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
560531|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
560532|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
560533|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
560534|NCT00883181|E6|Reported Event|Breast Total|All Breast Cancer
560535|NCT00883181|E5|Reported Event|Breast Metastatic|Breast Cancer, Metastatic
560536|NCT00883181|E4|Reported Event|Breast Stage I-III|Breast Cancer, Stages I-III
560537|NCT00883181|E3|Reported Event|SCLC|Small Cell Lung Cancer
560538|NCT00883181|E2|Reported Event|NSCLC|Non-small Cell Lung Cancer
560539|NCT00883181|E1|Reported Event|Ovarian|Ovarian Cancer
560540|NCT00883233|B5|Baseline|Total|Total of all reporting groups
560541|NCT00883233|B4|Baseline|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
560542|NCT00883233|B3|Baseline|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
560543|NCT00883233|B2|Baseline|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
560544|NCT00883233|B1|Baseline|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
560545|NCT00883233|P4|Participant Flow|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
560546|NCT00883233|P3|Participant Flow|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
560547|NCT00883233|P2|Participant Flow|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
560548|NCT00883233|P1|Participant Flow|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
560549|NCT00883233|O4|Outcome|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
560550|NCT00883233|O3|Outcome|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
560551|NCT00883233|O2|Outcome|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
560552|NCT00883233|O1|Outcome|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
560553|NCT00883233|E4|Reported Event|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
560554|NCT00883233|E3|Reported Event|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
560555|NCT00883233|E2|Reported Event|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
560556|NCT00883233|E1|Reported Event|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
560557|NCT00883246|B1|Baseline|Atherectomy|"All patients enrolled in this single-arm study were treated with directional atherectomy.
SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
560558|NCT00883246|P1|Participant Flow|Atherectomy|"All patients enrolled in this single-arm study were treated with directional atherectomy.
SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
560559|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
560560|NCT00883246|O1|Outcome|CLI Subgroup|Wound healing was assessed in subjects who had Rutherford Clinical Category score of 5 or 6 at the time of enrollment.
560561|NCT00883246|O1|Outcome|Claudicant Subjects|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
560562|NCT00883246|O1|Outcome|CLI Subgroup|Subjects who had CLI (RCC 4 – 6) at time of enrollment
560563|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
560564|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.
SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
560565|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.
SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
560566|NCT00883246|O2|Outcome|Claudicant Subgroup (One Year)|"All claudicant subjects (RCC 1-3) enrolled in this single-arm study were treated with directional atherectomy and walking distance measured at the one year follow-up visit.
SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
560567|NCT00883246|O1|Outcome|Claudicant Subgroup (Baseline)|"All claudicant subjects enrolled in this single-arm study were treated with directional atherectomy and had walking distance measured prior to treatment.
SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
560568|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.
SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
560569|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.
SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
560570|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.
SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
560571|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.
SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
560572|NCT00883246|O1|Outcome|CLI Subgroup|Subjects who had CLI (RCC 4 – 6) at time of enrollment
560573|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
560574|NCT00883246|E1|Reported Event|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.
SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
560575|NCT00883337|B4|Baseline|Total|Total of all reporting groups
560576|NCT00883337|B3|Baseline|IFNβ1a / Teriflunomide 14 mg|"Core treatment period: Interferon β-1a 3 times a week.
Extension treatment period: Teriflunomide 14 mg once daily."
560577|NCT00883337|B2|Baseline|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg once daily.
Extension treatment period: Teriflunomide 14 mg once daily."
560578|NCT00883337|B1|Baseline|Teriflunomide 7 mg / 14 mg|"Core treatment period: Teriflunomide 7 mg once daily
Extension treatment period: Teriflunomide 14 mg once daily"
560579|NCT00883337|P3|Participant Flow|IFN-β-1a / Teriflunomide 14 mg|"Core treatment period: Interferon β-1a 3 times a week.
Extension treatment period: Teriflunomide 14 mg once daily."
560580|NCT00883337|P2|Participant Flow|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg once daily.
Extension treatment period: Teriflunomide 14 mg once daily."
560581|NCT00883337|P1|Participant Flow|Teriflunomide 7 mg/14 mg|"Core treatment period: Teriflunomide 7 mg once daily.
Extension treatment period: Teriflunomide 14 mg once daily."
560582|NCT00883337|O3|Outcome|IFN-β-1a / 14 mg|Core treatment period: Interferon β1a 3 times a week. Extension treatment period: Teriflunomide 14 mg once daily.
560583|NCT00883337|O2|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
560584|NCT00883337|O1|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
560585|NCT00883337|O3|Outcome|IFN-β-1a / 14 mg|Core treatment period: Interferon β1a 3 times a week. Extension treatment period: Teriflunomide 14 mg once daily.
560586|NCT00883337|O2|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
560587|NCT00883337|O1|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
560588|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
560589|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
560590|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
560591|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
560592|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
560593|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
560594|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
560595|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
560596|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
560597|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
560598|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
560599|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
560600|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
560601|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
560602|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
560603|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
560604|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
560605|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
560606|NCT00883337|E6|Reported Event|Extended Treatment: Teriflunomide 14 mg (After IFN-β-1a)|Teriflunomide 14 mg once daily in extended treatment period after Interferon β-1a 3 times a week in core treatment period (mean exposure of 1000.03 days).
560607|NCT00883337|E5|Reported Event|Extended Treatment: Teriflunomide 14 mg (After 14 mg)|Teriflunomide 14 mg once daily in extended treatment period after 14 mg in core treatment period (mean exposure of 1015.32 days).
560608|NCT00883337|E4|Reported Event|Extended Treatment: Teriflunomide 14 mg (After 7 mg)|Teriflunomide 14 mg once daily in extended treatment period after 7 mg in the core treatment period (mean exposure of 996.76 days).
560609|NCT00883337|E3|Reported Event|Core Treatment: IFN-β-1a|Interferon β-1a 3 times a week (mean exposure of 405.18 days).
560610|NCT00883337|E2|Reported Event|Core Treatment:Teriflunomide 14 mg|Teriflunomide 14 mg once daily (mean exposure of 434.43 days).
560611|NCT00883337|E1|Reported Event|Core Treatment Period: Teriflunomide 7 mg|Teriflunomide 7 mg once daily (mean exposure of 456.62 days).
560612|NCT00883389|B1|Baseline|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
560613|NCT00883389|P1|Participant Flow|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
560614|NCT00883389|O1|Outcome|Med-alert Pilot Group|Participants in pilot study assigned a med-alert device of bracelet or necklace
560615|NCT00883389|E1|Reported Event|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
560616|NCT00883493|B3|Baseline|Total|Total of all reporting groups
560617|NCT00883493|B2|Baseline|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560618|NCT00883493|B1|Baseline|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560619|NCT00883493|P2|Participant Flow|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560620|NCT00883493|P1|Participant Flow|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560621|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560622|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560623|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560624|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560625|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560626|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560627|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
561209|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
560628|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560629|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560630|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560631|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560632|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560633|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560634|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560635|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560636|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560637|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560638|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560639|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560640|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560641|NCT00883493|E2|Reported Event|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
560642|NCT00883493|E1|Reported Event|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
560643|NCT00883558|B1|Baseline|All Randomized Participants|"Following a 1-month titration period, participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle.
INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually.
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump."
560644|NCT00883558|P3|Participant Flow|Insulin Lispro First, Then INSULIN-PH20 NP|"Following a 1-month dose titration period, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.
Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
560645|NCT00883558|P2|Participant Flow|INSULIN-PH20 NP First, Then Insulin Lispro|"Following a 1-month dose titration period, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.
INSULIN-PH20 NP (Treatment A): 100 units per milliliter (U/mL) non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
560646|NCT00883558|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a 1-month dose titration period.
Insulin Lispro (Titration Period): 100 units per milliliter (U/mL), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 1 month.
Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
560647|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
560648|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
560649|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
560650|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
560651|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
560652|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
560653|NCT00883558|E2|Reported Event|Insulin Lispro Treatment Period|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
560654|NCT00883558|E1|Reported Event|INSULIN-PH20 NP Treatment Period|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
560655|NCT00883675|B1|Baseline|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
560656|NCT00883675|P1|Participant Flow|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
560657|NCT00883675|O1|Outcome|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
560658|NCT00883675|E1|Reported Event|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
560659|NCT00883740|B1|Baseline|Entire Study Population|Includes groups randomized to receive matching placebo and Pregabalin, 75 up to 225 mg, twice per day in the first intervention and Pregabalin, 75 up to 225 mg, and matching placebo twice per day in the second intervention
560660|NCT00883740|P2|Participant Flow|Pregabalin, Then Placebo|Pregabalin 75 mg up to 225 mg twice per day in intervention (treatment period 1, weeks 1-4) and matching placebo twice daily in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
560661|NCT00883740|P1|Participant Flow|Placebo, Then Pregabalin|Matching placebo twice daily in first intervention (treatment period 1, weeks 1-4) and pregabalin 75 milligrams (mg) up to 225 mg twice per day in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
560662|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560663|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560664|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560665|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560666|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560667|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560668|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560669|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560670|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560671|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560672|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560673|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560674|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560675|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560676|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560677|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560678|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560679|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560680|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560681|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560682|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560683|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560684|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560685|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560686|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560687|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560688|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560689|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560690|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560691|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560692|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560693|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560694|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560695|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560696|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560697|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560698|NCT00883740|E2|Reported Event|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560699|NCT00883740|E1|Reported Event|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
560700|NCT00883753|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560701|NCT00883753|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560702|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560703|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560704|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560705|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560706|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560707|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560708|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560975|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
560709|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560710|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560711|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560712|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560713|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560714|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560715|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560716|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560717|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560718|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560719|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560720|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560721|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560722|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560723|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560724|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560725|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560726|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560727|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560728|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560729|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560730|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560731|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560732|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560733|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560734|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560735|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560736|NCT00883753|O3|Outcome|Tocilizumab + > 1 DMARD|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were taking more than one DMARD at Core study Baseline.
560737|NCT00883753|O2|Outcome|Tocilizumab + 1 DMARD|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were taking one DMARD at Core study Baseline.
560738|NCT00883753|O1|Outcome|Tocilizumab Monotherapy|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were not taking DMARDS at Core Baseline.
560739|NCT00883753|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
560740|NCT00883779|B3|Baseline|Total|Total of all reporting groups
560741|NCT00883779|B2|Baseline|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560742|NCT00883779|B1|Baseline|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560743|NCT00883779|P2|Participant Flow|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 milligrams per day (mg/day) from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560744|NCT00883779|P1|Participant Flow|Placebo|Participants received 1250 milligrams per squared meter (mg/m^2) of gemcitabine intravenous (IV) infusion on Day 1 and 8, carboplatin 5 times (5x) area under concentration versus time curve (AUC) or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day Cycle) until disease progression (PD), unacceptable toxicity or death in primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560745|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560811|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560976|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
572615|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
560746|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560747|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560748|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560749|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560750|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560751|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560752|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560753|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560920|NCT00884325|O2|Outcome|Subjects Receiving Placebo|
560921|NCT00884325|O1|Outcome|Subjects Receiving Xyzal|
560922|NCT00884325|O2|Outcome|Subjects Receiving Placebo|
560923|NCT00884325|O1|Outcome|Subjects Receiving Xyzal|
560924|NCT00884325|E2|Reported Event|Subjects Receiving Placebo|
560925|NCT00884325|E1|Reported Event|Subjects Receiving Xyzal|
560754|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560755|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560756|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560757|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560758|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560759|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560760|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560761|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560926|NCT00884377|B3|Baseline|Total|Total of all reporting groups
560977|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
561076|NCT00884949|O1|Outcome|0.1 mg/kg/Week|"Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week"
560762|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560763|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560764|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560765|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560766|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560767|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560768|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560769|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560970|NCT00884585|B1|Baseline|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
561053|NCT00884832|E1|Reported Event|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
560770|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560771|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560772|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560773|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560774|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560775|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560776|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560777|NCT00883779|E2|Reported Event|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
560971|NCT00884585|P2|Participant Flow|Placebo Followed by COS|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
561054|NCT00884897|B3|Baseline|Total|Total of all reporting groups
560778|NCT00883779|E1|Reported Event|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
560779|NCT00884039|B3|Baseline|Total|Total of all reporting groups
560780|NCT00884039|B2|Baseline|15 mg Anecortave Acetate|
560781|NCT00884039|B1|Baseline|30 mg Anecortave Acetate|
560782|NCT00884039|P2|Participant Flow|15 mg Anecortave Acetate|
560783|NCT00884039|P1|Participant Flow|30 mg Anecortave Acetate|
560784|NCT00884039|O2|Outcome|15 mg Anecortave Acetate|
560785|NCT00884039|O1|Outcome|30 mg Anecortave Acetate|
560786|NCT00884039|E2|Reported Event|15 mg Anecortave Acetate|
560787|NCT00884039|E1|Reported Event|30 mg Anecortave Acetate|
560788|NCT00884065|B3|Baseline|Total|Total of all reporting groups
560789|NCT00884065|B2|Baseline|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
560790|NCT00884065|B1|Baseline|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
560791|NCT00884065|P2|Participant Flow|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
560792|NCT00884065|P1|Participant Flow|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
560793|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
560794|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
560795|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
560796|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
560797|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
560798|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
560799|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
560800|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
560801|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
560802|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
560803|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
560804|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
560805|NCT00884065|E2|Reported Event|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
560806|NCT00884065|E1|Reported Event|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
560807|NCT00884117|B1|Baseline|Otherwise Healthy Participants Infected With Influenza|Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560808|NCT00884117|P1|Participant Flow|All Participants Infected With Influenza|Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, otherwise healthy/non-immunocompromised adults and children greater than or equal to (≥) 1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include healthy or immunocompromised children less than or equal to (≤) 12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560809|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560810|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
561210|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
560812|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560813|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560814|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560815|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560816|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560817|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560818|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560819|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560820|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560821|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560822|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560823|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560824|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560825|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560826|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560827|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560828|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560829|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560830|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560831|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560832|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560833|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560834|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560835|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560836|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560837|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560838|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560839|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560840|NCT00884117|O6|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560841|NCT00884117|O5|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560842|NCT00884117|O4|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560843|NCT00884117|O3|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560844|NCT00884117|O2|Outcome|Children 1 to 5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 1 to 5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560845|NCT00884117|O1|Outcome|Children <1 Year of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children less than (<) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 6 and 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560846|NCT00884117|O1|Outcome|Otherwise Healthy Participants Infected With Influenza|Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560847|NCT00884117|E2|Reported Event|Participants Not Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants not receiving oseltamivir, including no treatment or other antiviral treatment, were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560848|NCT00884117|E1|Reported Event|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
560849|NCT00884221|B3|Baseline|Total|Total of all reporting groups
560850|NCT00884221|B2|Baseline|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560851|NCT00884221|B1|Baseline|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560852|NCT00884221|P2|Participant Flow|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. Hereafter, the subjects were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation. From stimulation day 6 and onwards, dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days. Coasting was prohibited.
560853|NCT00884221|P1|Participant Flow|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. Hereafter, the subjects were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation. From stimulation day 6 and onwards, dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days. Coasting was prohibited.
560854|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560855|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
561211|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
560856|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560857|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560858|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560859|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560860|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560861|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560862|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560863|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560864|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560865|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560866|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560867|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560868|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560869|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560870|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560871|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560872|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560873|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560874|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560875|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560876|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560877|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560878|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560879|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560880|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560881|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560882|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560972|NCT00884585|P1|Participant Flow|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
560973|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
560883|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
560884|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560885|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560886|NCT00884221|E2|Reported Event|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560887|NCT00884221|E1|Reported Event|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
560888|NCT00884273|B3|Baseline|Total|Total of all reporting groups
560889|NCT00884273|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560890|NCT00884273|B1|Baseline|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560891|NCT00884273|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560892|NCT00884273|P1|Participant Flow|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560893|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560894|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560895|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560896|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560897|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560898|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560974|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
572616|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
560899|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560900|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560901|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560902|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560903|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560904|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560905|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560906|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560907|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560908|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560909|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560910|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560911|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560912|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560913|NCT00884273|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
560914|NCT00884273|E1|Reported Event|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
560915|NCT00884325|B3|Baseline|Total|Total of all reporting groups
560916|NCT00884325|B2|Baseline|Subjects Receiving Placebo|
560917|NCT00884325|B1|Baseline|Subjects Receiving Xyzal|
560918|NCT00884325|P2|Participant Flow|Subjects Receiving Placebo|one tablet taken orally at night for 28 days
560919|NCT00884325|P1|Participant Flow|Subjects Receiving Xyzal|one tablet, 5 mg, taken orally at night for 28 days
560927|NCT00884377|B2|Baseline|Treatment With Thermomed Device|Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated
560928|NCT00884377|B1|Baseline|Treatment With IV Sodium Stibogluconate|Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic.
560929|NCT00884377|P2|Participant Flow|Treatment With Thermomed Device|Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated
560930|NCT00884377|P1|Participant Flow|Treatment With IV Sodium Stibogluconate|Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic.
560931|NCT00884377|O2|Outcome|ThermoMed Device|ThermoMed device group
560932|NCT00884377|O1|Outcome|Sodium Stibogluconate|Sodium Stibogluconate group
560933|NCT00884377|O4|Outcome|Study Day 10: ThermoMed|Day 10: ThermoMed group
560934|NCT00884377|O3|Outcome|Study Day 1: ThermoMed|Day 1: TherrmoMed group
560935|NCT00884377|O2|Outcome|Study Day 10: Sodium Stibogluconate|Day 10: Sodium Stibogluconate group
560936|NCT00884377|O1|Outcome|Study Day 1: Sodium Stibogluconate|Day 1: Sodium Stibogluconate group
560937|NCT00884377|O4|Outcome|Study Day 10: ThermoMed|Day 10: ThermoMed group
560938|NCT00884377|O3|Outcome|Study Day 1: ThermoMed|Day 1: TherrmoMed group
560939|NCT00884377|O2|Outcome|Study Day 10: Sodium Stibogluconate|Day 10: Sodium Stibogluconate group
560940|NCT00884377|O1|Outcome|Study Day 1: Sodium Stibogluconate|Day 1: Sodium Stibogluconate group
560941|NCT00884377|O2|Outcome|ThermoMed Treatment|ThermoMed Treatment Groups
560942|NCT00884377|O1|Outcome|Sodium Stibogluconate|Sodium Stibogluconate Groups
560943|NCT00884377|O2|Outcome|ThermoMed Device|ThermoMed device group
560944|NCT00884377|O1|Outcome|Sodium Stibogluconate|Sodium Stibogluconate group
560945|NCT00884377|O2|Outcome|ThermoMed Device|ThermoMed device group
560946|NCT00884377|O1|Outcome|Sodium Stibogluconate|Sodium Stibogluconate group
560947|NCT00884377|E2|Reported Event|ThermoMed Device|"ThermoMed device, single heat treatment at 50 degrees Celsius
ThermoMed: ThermoMed heat treatment device, one treatment"
560948|NCT00884377|E1|Reported Event|Sodium Stibogluconate Intravenous|"20 mg/kg/day Sodium stibogluconate intravenous
Sodium stibogluconate (Pentostam): intravenous 20 mg/kg/day for 10 days"
560949|NCT00884390|B3|Baseline|Total|Total of all reporting groups
560950|NCT00884390|B2|Baseline|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
560951|NCT00884390|B1|Baseline|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
560952|NCT00884390|P2|Participant Flow|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
560953|NCT00884390|P1|Participant Flow|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
560954|NCT00884390|O1|Outcome|All Participants With at Least One Prophylaxis Infusion|All enrolled participants with at least one prophylaxis infusion
560955|NCT00884390|O1|Outcome|All Participants With at Least One Bleed|All enrolled participants with at least one bleed.
560956|NCT00884390|O2|Outcome|Participants Following a Prophylaxis Regimen at Baseline|All enrolled participants following a prophylaxis regimen at baseline
560957|NCT00884390|O1|Outcome|Participants Following a Non-prophylaxis Regimen at Baseline|All enrolled participants following an on-demand or preventive regimen at baseline
560958|NCT00884390|O1|Outcome|All Participants|All enrolled participants following a non-prophylaxis regimen at baseline.
560959|NCT00884390|O1|Outcome|All Participants|All enrolled participants following a non-prophylaxis regimen at baseline.
560960|NCT00884390|O1|Outcome|Participants Who Received at Least One Prophylactic Infusion|Participants who had at least one prophylaxis dose, and at least one bleed.
560961|NCT00884390|O1|Outcome|Participants Who Received at Least One Prophylactic Infusion|Participants who had at least one prophylaxis dose, and at least one bleed.
560962|NCT00884390|O1|Outcome|All Participants With Bleeds|Includes any infusion with an associated bleeding episode, regardless of the reason for treatment indicated on the case report form
560963|NCT00884390|O1|Outcome|First Infusion Per Bleed|Includes the first infusion for an associated bleeding episode
560964|NCT00884390|O1|Outcome|Annualized Bleed Rate|ABR by regimen at baseline is summarized for all participants for on-demand regimen, preventive regimen and prophylaxis regimen, respectively
560965|NCT00884390|O2|Outcome|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
560966|NCT00884390|O1|Outcome|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
560967|NCT00884390|E1|Reported Event|All Participants|The primary safety analysis was performed on all subjects who received at least 1 dose of ReFacto AF.
560968|NCT00884585|B3|Baseline|Total|Total of all reporting groups
560969|NCT00884585|B2|Baseline|Placebo Followed by COS|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
560978|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
560979|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
560980|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
560981|NCT00884585|E2|Reported Event|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
560982|NCT00884585|E1|Reported Event|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
560983|NCT00884741|B4|Baseline|Total|Total of all reporting groups
560984|NCT00884741|B3|Baseline|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
560985|NCT00884741|B2|Baseline|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
560986|NCT00884741|B1|Baseline|Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
560987|NCT00884741|P4|Participant Flow|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
560988|NCT00884741|P3|Participant Flow|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
560989|NCT00884741|P2|Participant Flow|Step 2 Registration: Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization
560990|NCT00884741|P1|Participant Flow|Step 1 Registration|No treatment. Central Pathology Tissue Screening to confirm histology and adequacy of tissue for MGMT analysis and molecular profile. Tumor tissue must be received and central review confirmation completed before STEP 2 registration can occur.
560991|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
560992|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
560993|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
560994|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
560995|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
560996|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
560997|NCT00884741|E3|Reported Event|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
560998|NCT00884741|E2|Reported Event|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
560999|NCT00884741|E1|Reported Event|Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
561000|NCT00884754|B3|Baseline|Total|Total of all reporting groups
561001|NCT00884754|B2|Baseline|90º Curvature, Malleable Stylet|
561002|NCT00884754|B1|Baseline|Rigid GlideScope Specific Stylet|
561003|NCT00884754|P2|Participant Flow|90º Curvature, Malleable Stylet|
561004|NCT00884754|P1|Participant Flow|Rigid GlideScope Specific Stylet|
561005|NCT00884754|O2|Outcome|90º Curvature, Malleable Stylet|
561006|NCT00884754|O1|Outcome|Rigid GlideScope Specific Stylet|
561007|NCT00884754|E2|Reported Event|90º Curvature, Malleable Stylet|
561008|NCT00884754|E1|Reported Event|Rigid GlideScope Specific Stylet|
561009|NCT00884793|B1|Baseline|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
561010|NCT00884793|P1|Participant Flow|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
561011|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
561012|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
561013|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
561014|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
561075|NCT00884949|O2|Outcome|1.0 mg/kg/Week|"Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week"
572617|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
561015|NCT00884793|E1|Reported Event|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
561016|NCT00884806|B1|Baseline|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
561017|NCT00884806|P1|Participant Flow|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
561018|NCT00884806|O1|Outcome|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
561019|NCT00884806|O1|Outcome|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
561020|NCT00884806|E1|Reported Event|FID 114675A|Investigational multi-purpose contact lens solution
561021|NCT00884832|B3|Baseline|Total|Total of all reporting groups
561022|NCT00884832|B2|Baseline|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561023|NCT00884832|B1|Baseline|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561024|NCT00884832|P2|Participant Flow|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561025|NCT00884832|P1|Participant Flow|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561026|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561027|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561028|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561029|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561030|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561031|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561032|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561033|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561034|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561035|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561036|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561037|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561038|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561039|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561040|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561041|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561042|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561043|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561044|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561045|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561046|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561047|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561048|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561049|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561050|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561051|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
561052|NCT00884832|E2|Reported Event|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
561055|NCT00884897|B2|Baseline|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Placebo: Placebo given as 20 IU BID"
561056|NCT00884897|B1|Baseline|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Oxytocin: Oxytocin given as 20 IU BID"
561057|NCT00884897|P2|Participant Flow|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Placebo: Placebo given as 20 IU BID"
561058|NCT00884897|P1|Participant Flow|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Oxytocin: Oxytocin given as 20 IU BID"
561059|NCT00884897|O2|Outcome|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Placebo: Placebo given as 20 IU BID"
561060|NCT00884897|O1|Outcome|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Oxytocin: Oxytocin given as 20 IU BID"
561061|NCT00884897|O2|Outcome|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Placebo: Placebo given as 20 IU BID"
561062|NCT00884897|O1|Outcome|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Oxytocin: Oxytocin given as 20 IU BID"
561063|NCT00884897|E2|Reported Event|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Placebo: Placebo given as 20 IU BID"
561064|NCT00884897|E1|Reported Event|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Oxytocin: Oxytocin given as 20 IU BID"
561065|NCT00884910|B1|Baseline|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
561066|NCT00884910|P1|Participant Flow|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
561067|NCT00884910|O1|Outcome|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
561068|NCT00884910|O1|Outcome|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
561069|NCT00884910|E1|Reported Event|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
561070|NCT00884949|B1|Baseline|BMN 110|Dose-Escalation Period:
561071|NCT00884949|P1|Participant Flow|BMN 110|"Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
Weeks 1-12: 0.1 mg/kg/week
Weeks 13-24: 1.0 mg/kg/week
Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
561072|NCT00884949|O5|Outcome|Entire Study|Entire Study period includes both Dose-Escalation Period and Continuation Period.
561073|NCT00884949|O4|Outcome|Continuation Period|Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
561074|NCT00884949|O3|Outcome|2.0 mg/kg/Week|"Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week"
572618|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
561077|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
Weeks 1-12: 0.1 mg/kg/week
Weeks 13-24: 1.0 mg/kg/week
Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
561078|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
Weeks 1-12: 0.1 mg/kg/week
Weeks 13-24: 1.0 mg/kg/week
Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
561079|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
Weeks 1-12: 0.1 mg/kg/week
Weeks 13-24: 1.0 mg/kg/week
Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
561080|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
Weeks 1-12: 0.1 mg/kg/week
Weeks 13-24: 1.0 mg/kg/week
Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
561081|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
Weeks 1-12: 0.1 mg/kg/week
Weeks 13-24: 1.0 mg/kg/week
Weeks 25-36: 2.0 mg/kg/week
Continuation Period:
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
561082|NCT00884949|E5|Reported Event|Entire Study|Entire Study period includes both Dose-Escalation Period and Continuation Period.
561083|NCT00884949|E4|Reported Event|Continuation Period|Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
561084|NCT00884949|E3|Reported Event|2.0 mg/kg/Week|"Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week"
561085|NCT00884949|E2|Reported Event|1.0 mg/kg/Week|"Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week"
561086|NCT00884949|E1|Reported Event|0.1 mg/kg/Week|"Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week
Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week"
561087|NCT00885079|B3|Baseline|Total|Total of all reporting groups
561088|NCT00885079|B2|Baseline|Hyaluronate|"Instillation,6 times/day for 4 weeks
Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
561089|NCT00885079|B1|Baseline|Rebamipide|"Instillation,4 times/day for 4 weeks
OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
561090|NCT00885079|P2|Participant Flow|Hyaluronate|"Instillation,6 times/day for 4 weeks
Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
561091|NCT00885079|P1|Participant Flow|Rebamipide|"Instillation,4 times/day for 4 weeks
OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
561092|NCT00885079|O2|Outcome|Hyaluronate|"Instillation,6 times/day for 4 weeks
Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
561093|NCT00885079|O1|Outcome|Rebamipide|"Instillation,4 times/day for 4 weeks
OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
561094|NCT00885079|O2|Outcome|Hyaluronate|"Instillation,6 times/day for 4 weeks
Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
561095|NCT00885079|O1|Outcome|Rebamipide|"Instillation,4 times/day for 4 weeks
OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
561096|NCT00885079|E2|Reported Event|Hyaluronate|"Instillation,6 times/day for 4 weeks
Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
561097|NCT00885079|E1|Reported Event|Rebamipide|"Instillation,4 times/day for 4 weeks
OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
561098|NCT00885092|B3|Baseline|Total|Total of all reporting groups
561099|NCT00885092|B2|Baseline|RepleniSH / FID 114675A|RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
561100|NCT00885092|B1|Baseline|FID 114675A / RepleniSH|FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
561101|NCT00885092|P2|Participant Flow|RepleniSH / FID 114675A|RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
561102|NCT00885092|P1|Participant Flow|FID 114675A / RepleniSH|FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
561136|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
572619|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
561103|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
561104|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
561105|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
561106|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
561107|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
561108|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
561109|NCT00885092|E2|Reported Event|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.
561110|NCT00885092|E1|Reported Event|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.
561111|NCT00878228|B3|Baseline|Total|Total of all reporting groups
561112|NCT00878228|B2|Baseline|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
561113|NCT00878228|B1|Baseline|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
561114|NCT00878228|P2|Participant Flow|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
561115|NCT00878228|P1|Participant Flow|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
561116|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
561117|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
561118|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
561119|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
561120|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
561121|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
561122|NCT00878228|E2|Reported Event|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
561123|NCT00878228|E1|Reported Event|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
561124|NCT00885105|B3|Baseline|Total|Total of all reporting groups
561125|NCT00885105|B2|Baseline|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561126|NCT00885105|B1|Baseline|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561127|NCT00885105|P2|Participant Flow|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561128|NCT00885105|P1|Participant Flow|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561129|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561130|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561131|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561132|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561133|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561134|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561135|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561204|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561137|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561138|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561139|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561140|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561141|NCT00885105|E2|Reported Event|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561142|NCT00885105|E1|Reported Event|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
561143|NCT00885118|B6|Baseline|Total|Total of all reporting groups
561144|NCT00885118|B5|Baseline|Empa 25 mg|Treatment with Empa 25 mg once daily
561145|NCT00885118|B4|Baseline|Empa 10 mg|Treatment with Empa 10 mg once daily
561146|NCT00885118|B3|Baseline|Empa 5 mg|Treatment with Empa 5 mg once daily
561147|NCT00885118|B2|Baseline|Empa 1 mg|Treatment with Empa 1 mg once daily
561148|NCT00885118|B1|Baseline|Placebo|Treatment with placebo once daily
561149|NCT00885118|P5|Participant Flow|Empa 25 mg|Treatment with Empa 25 mg once daily
561150|NCT00885118|P4|Participant Flow|Empa 10 mg|Treatment with Empa 10 mg once daily
561151|NCT00885118|P3|Participant Flow|Empa 5 mg|Treatment with Empa 5 mg once daily
561152|NCT00885118|P2|Participant Flow|Empa 1 mg|Treatment with Empa 1 mg once daily
561153|NCT00885118|P1|Participant Flow|Placebo|Treatment with placebo once daily
561154|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561155|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561156|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561157|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561158|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561159|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561160|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561161|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561162|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561163|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561164|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561165|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561166|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561167|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561168|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561169|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561170|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561171|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561172|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561173|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561174|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561175|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561176|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561177|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561178|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561179|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561180|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561181|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561182|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561183|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561184|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561185|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561186|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561187|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561188|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561189|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561190|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561191|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561192|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561193|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561194|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561195|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561196|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561197|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561198|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561199|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561200|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561201|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561202|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561203|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561212|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561213|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561214|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561215|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561216|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561217|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561218|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561219|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561220|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561221|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561222|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561223|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561224|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561225|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561226|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561227|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561228|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561229|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561230|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561231|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561232|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561233|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561234|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561235|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561236|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561237|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561238|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
561239|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561240|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561241|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561242|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561243|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
561244|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561245|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561246|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561247|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561248|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
561249|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561250|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561251|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561252|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561253|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
561254|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561255|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561256|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561257|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561258|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
561259|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561260|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561261|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561262|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561263|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
561264|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561265|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561266|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561267|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561268|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
561269|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561270|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561271|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561272|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561273|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
561274|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561275|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561276|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561277|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561278|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
561279|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
561280|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
561281|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
561282|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
561283|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
561284|NCT00885118|E5|Reported Event|Empa 25 mg|Treatment with Empa 25 mg once daily
561285|NCT00885118|E4|Reported Event|Empa 10 mg|Treatment with Empa 10 mg once daily
561286|NCT00885118|E3|Reported Event|Empa 5 mg|Treatment with Empa 5 mg once daily
561287|NCT00885118|E2|Reported Event|Empa 1 mg|Treatment with Empa 1 mg once daily
561288|NCT00885118|E1|Reported Event|Placebo|Treatment with placebo once daily
561289|NCT00885170|B3|Baseline|Total|Total of all reporting groups
561290|NCT00885170|B2|Baseline|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561291|NCT00885170|B1|Baseline|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561292|NCT00885170|P2|Participant Flow|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561293|NCT00885170|P1|Participant Flow|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561294|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561295|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561296|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561297|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561298|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561299|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561300|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561301|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561302|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561303|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561304|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561305|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561306|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561307|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561308|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561309|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561310|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561311|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561312|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561388|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561313|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561314|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561315|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561316|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561317|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561318|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561319|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561320|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561321|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561322|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561323|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561324|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561325|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561326|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561327|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561328|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561329|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561330|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561331|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561332|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561333|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561334|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561335|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561336|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561337|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561338|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561339|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561340|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561341|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561342|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561343|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561344|NCT00885170|E2|Reported Event|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561345|NCT00885170|E1|Reported Event|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
561346|NCT00885352|B3|Baseline|Total|Total of all reporting groups
561347|NCT00885352|B2|Baseline|Placebo|Placebo to sitagliptin once daily
561348|NCT00885352|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily
561349|NCT00885352|P2|Participant Flow|Placebo|Placebo to sitagliptin once daily
561350|NCT00885352|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily
561351|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
561352|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
561353|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
561354|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
561355|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
561356|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
561357|NCT00885352|E2|Reported Event|Placebo|Placebo to sitagliptin once daily
561358|NCT00885352|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
561359|NCT00885365|B3|Baseline|Total|Total of all reporting groups
561360|NCT00885365|B2|Baseline|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561361|NCT00885365|B1|Baseline|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561362|NCT00885365|P2|Participant Flow|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561363|NCT00885365|P1|Participant Flow|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561364|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561365|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561366|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561367|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561368|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561369|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561370|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561371|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561372|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561373|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561374|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561375|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561376|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561377|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561378|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561379|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561380|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561381|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561382|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561383|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561384|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561385|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561386|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561387|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561389|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561390|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561391|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561392|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561393|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561394|NCT00885365|E2|Reported Event|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
561395|NCT00885365|E1|Reported Event|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
561396|NCT00885378|B3|Baseline|Total|Total of all reporting groups
561397|NCT00885378|B2|Baseline|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561398|NCT00885378|B1|Baseline|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561399|NCT00885378|P2|Participant Flow|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561400|NCT00885378|P1|Participant Flow|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561401|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561402|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561403|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561404|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561405|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561406|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561407|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561408|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561409|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561410|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561411|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561412|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561413|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561414|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561415|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561416|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561417|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561418|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561419|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561420|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561421|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561422|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561423|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561424|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561425|NCT00885378|E2|Reported Event|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
561426|NCT00885378|E1|Reported Event|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
561427|NCT00885638|B1|Baseline|All Study Participants|Placebo first, then sitagliptin or sitagliptin first, then placebo
561428|NCT00885638|P2|Participant Flow|Sitagliptin First, Then Placebo|First intervention 1 day, washout 14 days, second intervention 1 day
561429|NCT00885638|P1|Participant Flow|Placebo First, Then Sitagliptin|First intervention 1 day, washout 14 days, second intervention 1 day
561430|NCT00885638|O2|Outcome|Sitagliptin|Sitagliptin is given before ingestion of meal
561431|NCT00885638|O1|Outcome|Placebo|A placebo tablet is given before ingestion of meal
561432|NCT00885638|O2|Outcome|Sitagliptin|Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for sitagliptin
561433|NCT00885638|O1|Outcome|Placebo|Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for placebo
561434|NCT00885638|E1|Reported Event|All Study Participants|Placebo first, then sitagliptin or sitagliptin first, then placebo
561435|NCT00885677|B3|Baseline|Total|Total of all reporting groups
561436|NCT00885677|B2|Baseline|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
561492|NCT00885846|B3|Baseline|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
561545|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
561437|NCT00885677|B1|Baseline|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.
Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.
Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
561438|NCT00885677|P2|Participant Flow|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
561439|NCT00885677|P1|Participant Flow|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.
Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.
Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
561440|NCT00885677|O2|Outcome|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
561441|NCT00885677|O1|Outcome|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.
Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.
Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
561442|NCT00885677|O2|Outcome|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
561443|NCT00885677|O1|Outcome|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.
Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.
Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
561444|NCT00885677|E2|Reported Event|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
561445|NCT00885677|E1|Reported Event|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.
Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.
Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
561446|NCT00885742|B1|Baseline|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
561447|NCT00885742|P1|Participant Flow|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
561448|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
561449|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
561450|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
561451|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
561452|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
561453|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
561454|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
561455|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
561456|NCT00885742|E1|Reported Event|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
561457|NCT00885755|B4|Baseline|Total|Total of all reporting groups
561458|NCT00885755|B3|Baseline|No Group|This group included participants who died before any on study disease assessments or post-baseline biopsies. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression.
561493|NCT00885846|B2|Baseline|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
561494|NCT00885846|B1|Baseline|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
561495|NCT00885846|P3|Participant Flow|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
561496|NCT00885846|P2|Participant Flow|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
561459|NCT00885755|B2|Baseline|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561460|NCT00885755|B1|Baseline|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561461|NCT00885755|P3|Participant Flow|No Group|This group included participants who died before any study disease assessments or post-baseline biopsies. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression.
561462|NCT00885755|P2|Participant Flow|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561463|NCT00885755|P1|Participant Flow|Group A:Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 milligrams per square meter (mg/m^2) or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on Body Surface Area (BSA) on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561464|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561465|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561497|NCT00885846|P1|Participant Flow|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
561498|NCT00885846|O3|Outcome|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
561499|NCT00885846|O2|Outcome|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
561500|NCT00885846|O1|Outcome|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
572620|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
561466|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561467|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561468|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561469|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561470|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561471|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561472|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561501|NCT00885846|E3|Reported Event|Control|Wait list group; no activity at this arm. On list to start Qigong
561502|NCT00885846|E2|Reported Event|Progressive Resistance Training|Progressive resistance training: For 12 weeks, subjects in the PRT group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
561506|NCT00886015|B1|Baseline|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
572621|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
561473|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561474|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561475|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561476|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561477|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561478|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561479|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561503|NCT00885846|E1|Reported Event|Qigong Therapy|Qigong therapy: For 12 weeks, subjects in Qigong therapy group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
561504|NCT00886015|B3|Baseline|Total|Total of all reporting groups
561505|NCT00886015|B2|Baseline|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
572622|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
561480|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561481|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561482|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561483|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561484|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561485|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561486|NCT00885755|E1|Reported Event|All Participants|In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Trastuzumab was administered according to SMPC. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
561487|NCT00885768|B1|Baseline|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
561488|NCT00885768|P1|Participant Flow|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
561489|NCT00885768|O1|Outcome|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
561490|NCT00885768|E1|Reported Event|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
561491|NCT00885846|B4|Baseline|Total|Total of all reporting groups
561507|NCT00886015|P2|Participant Flow|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
561508|NCT00886015|P1|Participant Flow|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
561509|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.
Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
561510|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.
TT Clamp: trichiasis surgery performed with TT clamp"
561511|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.
Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
561512|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.
TT Clamp: trichiasis surgery performed with TT clamp"
561513|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.
Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
561514|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.
TT Clamp: trichiasis surgery performed with TT clamp"
561515|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.
Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
561516|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.
TT Clamp: trichiasis surgery performed with TT clamp"
561517|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.
Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
561518|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.
TT Clamp: trichiasis surgery performed with TT clamp"
561519|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.
Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
561520|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.
TT Clamp: trichiasis surgery performed with TT clamp"
561521|NCT00886015|E2|Reported Event|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
561522|NCT00886015|E1|Reported Event|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
561523|NCT00886119|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
561524|NCT00886119|P2|Participant Flow|Omafilcon A / Lotrafilcon B|Omafilcon A multifocal contact lens worn first, with Lotrafilcon B multifocal contact lens worn second. Both products worn in a daily wear basis.
561525|NCT00886119|P1|Participant Flow|Lotrafilcon B / Omafilcon A|Lotrafilcon B multifocal contact lens worn first, with Omafilcon A multifocal contact lens worn second. Both products worn in a daily wear basis.
561526|NCT00886119|O2|Outcome|Omafilcon A|Hydrogel, soft, multifocal contact lens for daily wear
561527|NCT00886119|O1|Outcome|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens for daily wear use
561528|NCT00886119|E2|Reported Event|Omafilcon A|Hydrogel, soft, multifocal contact lens for daily wear
561529|NCT00886119|E1|Reported Event|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens for daily wear
561530|NCT00886145|B1|Baseline|Vibration- Right Leg and No Vibration-left Leg|"The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month."
561531|NCT00886145|P1|Participant Flow|Vibration: Right Leg and No Vibration: Left Leg|"The subjects will undergo vibration intervention in the seated position, 5 sessions a week, each session lasting 20 minutes for 6 months. All footwear will be removed, but they may wear socks or be barefoot. Only the right leg will be vibrated and the left leg will serve as a control. The frequency and force of the vibrations will be approximately 35 Hz and 0.3 g.
In additional load of 50lbs will be added to both legs by using an extra wide strap equipped with bungee cords."
561532|NCT00886145|O2|Outcome|No Vibration- Left Leg|No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
561533|NCT00886145|O1|Outcome|Vibration- Right Leg|Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
561534|NCT00886145|E2|Reported Event|No Vibration-left Leg:|No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
561535|NCT00886145|E1|Reported Event|Vibration- Right Leg:|Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
561536|NCT00886288|B3|Baseline|Total|Total of all reporting groups
561537|NCT00886288|B2|Baseline|Patients With Albuminuria Treated With Telmisartan|baseline population
561538|NCT00886288|B1|Baseline|Patients Without Albuminuria Treated With Telmisartan|baseline population
561539|NCT00886288|P2|Participant Flow|Patients With Albuminuria Treated With Telmisartan|
561540|NCT00886288|P1|Participant Flow|Patients Without Albuminuria Treated With Telmisartan|
561541|NCT00886288|O1|Outcome|Patients With Albuminuria Treated With Telmisartan|
561542|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
561543|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
561544|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
561546|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
561547|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
561548|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
561549|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
561550|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
561551|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
561552|NCT00886288|E3|Reported Event||patients without baseline albuminuria data
561553|NCT00886288|E2|Reported Event|Patients With Albuminuria Treated With Telmisartan|
561554|NCT00886288|E1|Reported Event|Patients Without Albuminuria Treated With Telmisartan|
561555|NCT00886340|B3|Baseline|Total|Total of all reporting groups
561556|NCT00886340|B2|Baseline|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
561557|NCT00886340|B1|Baseline|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
561558|NCT00886340|P2|Participant Flow|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
561559|NCT00886340|P1|Participant Flow|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
561560|NCT00886340|O2|Outcome|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
561561|NCT00886340|O1|Outcome|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
561562|NCT00886340|E2|Reported Event|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
561563|NCT00886340|E1|Reported Event|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
561564|NCT00886483|B3|Baseline|Total|Total of all reporting groups
561565|NCT00886483|B2|Baseline|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant’s brainwave power spectrum.
561566|NCT00886483|B1|Baseline|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
561567|NCT00886483|P2|Participant Flow|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
561568|NCT00886483|P1|Participant Flow|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
561569|NCT00886483|O2|Outcome|Sham Neurofeedback|Participants in the Sham group completing 40 treatments
561570|NCT00886483|O1|Outcome|Active Neurofeedback|All participants in the Active group completing 40 treatments
561571|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 24th treatment (n=10).
561572|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 24th treatment (n=24).
561573|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 24th treatment (n=10).
561574|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 24th treatment (n=24).
561575|NCT00886483|O2|Outcome|Sham Neurofeedback|Correct guess vs. incorrect guess/don't know/decline to guess for Sham Neurofeedback group.
561576|NCT00886483|O1|Outcome|Active Neurofeedback|Correct guess vs. incorrect guess/don't know/decline to guess for Neurofeedback group.
561577|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 40th treatment (n=10).
561578|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 40th treatment (n=24).
561579|NCT00886483|O2|Outcome|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
561580|NCT00886483|O1|Outcome|Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
561581|NCT00886483|E2|Reported Event|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant’s brainwave power spectrum.
561582|NCT00886483|E1|Reported Event|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
561583|NCT00886587|B3|Baseline|Total|Total of all reporting groups
561584|NCT00886587|B2|Baseline|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561585|NCT00886587|B1|Baseline|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561614|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561586|NCT00886587|P2|Participant Flow|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561587|NCT00886587|P1|Participant Flow|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561588|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561589|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561590|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561591|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561592|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561593|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561594|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561595|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561596|NCT00886587|E2|Reported Event|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561597|NCT00886587|E1|Reported Event|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
561598|NCT00886600|B5|Baseline|Total|Total of all reporting groups
561599|NCT00886600|B4|Baseline|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561600|NCT00886600|B3|Baseline|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
561601|NCT00886600|B2|Baseline|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561602|NCT00886600|B1|Baseline|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561603|NCT00886600|P4|Participant Flow|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 50 mg orally twice daily (b.i.d.) for 4 weeks
Combination Therapy Period: Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
561604|NCT00886600|P3|Participant Flow|Losartan 100 mg q.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 100 mg orally once daily (q.d.) for 4 weeks
Combination Therapy Period:Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy).orally once daily for 2 weeks"
561605|NCT00886600|P2|Participant Flow|Losartan 50 mg q.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 50 mg orally once daily (q.d.) for 4 weeks
Combination Therapy Period: Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
561606|NCT00886600|P1|Participant Flow|Placebo / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan placebo orally once daily for 4 weeks
Combination Therapy Period: Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
561607|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561608|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
561609|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561610|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561611|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561612|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
561613|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561615|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561616|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
561617|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561618|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561619|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561620|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
561621|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561622|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561623|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561624|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
561625|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561626|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
561627|NCT00886613|B4|Baseline|Total|Total of all reporting groups
561628|NCT00886613|B3|Baseline|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
561629|NCT00886613|B2|Baseline|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
561630|NCT00886613|B1|Baseline|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)
administered at Day 1 and Day 31."
561631|NCT00886613|P3|Participant Flow|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
561632|NCT00886613|P2|Participant Flow|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
561633|NCT00886613|P1|Participant Flow|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)
administered at Day 1 and Day 31."
561634|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
561635|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
561636|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)
administered at Day 1 and Day 31."
561637|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
561638|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
561639|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)
administered at Day 1 and Day 31."
561640|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
561641|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
561642|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)
administered at Day 1 and Day 31."
561643|NCT00886613|O2|Outcome|Part A Participants - VZV Skin Reaction (72 Hrs)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction after 72 hours.
561644|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (48 Hrs)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction after 48 hours.
561645|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (Baseline)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction at baseline.
561646|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (Baseline)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction at baseline.
561647|NCT00886613|E3|Reported Event|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
561648|NCT00886613|E2|Reported Event|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
561649|NCT00886613|E1|Reported Event|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)
administered at Day 1 and Day 31."
561650|NCT00886626|B1|Baseline|All Participants|All enrolled participants
561651|NCT00886626|P2|Participant Flow|Control Then Exenatide|No medication control for 3-months then exenatide 5 mcg for 1-month uptitrated to 10 mcg for following 2-months
561652|NCT00886626|P1|Participant Flow|Exenatide Then Control|Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months followed by control for 3-months
561653|NCT00886626|O2|Outcome|Control|No medication control for 3-months. Participants came from period 1 and period 2.
561654|NCT00886626|O1|Outcome|Exenatide|Exenatide 5 mcg for 1-month then up-titration to 10-mcg for remaining 2-months. Participants came from period 1 and period 2.
561655|NCT00886626|E2|Reported Event|Control|No medication control for 3-months.
561656|NCT00886626|E1|Reported Event|Exenatide|Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months.
561657|NCT00886639|B1|Baseline|6MWT With Different Gas Mixtures|
561658|NCT00886639|P1|Participant Flow|6MWT With Different Gas Mixtures|
561659|NCT00886639|O1|Outcome|Oxygen Response|difference between 6-minute-walking test on oxygen and on medical air
561660|NCT00886639|E1|Reported Event|6MWT With Different Gas Mixtures|
561661|NCT00886704|B3|Baseline|Total|Total of all reporting groups
561662|NCT00886704|B2|Baseline|Convenience Drink Without EPA and DHA|
561663|NCT00886704|B1|Baseline|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
561664|NCT00886704|P2|Participant Flow|Convenience Drink Without EPA and DHA|
561665|NCT00886704|P1|Participant Flow|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
561666|NCT00886704|O2|Outcome|Convenience Drink Without EPA and DHA|
561667|NCT00886704|O1|Outcome|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
561668|NCT00886704|O2|Outcome|Convenience Drink Without EPA and DHA|Palatability
561669|NCT00886704|O1|Outcome|Convenience Drink With EPA and DHA|Palatability
561670|NCT00886704|E2|Reported Event|Convenience Drink Without EPA and DHA|
561671|NCT00886704|E1|Reported Event|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
561672|NCT00886743|B1|Baseline|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
561673|NCT00886743|P1|Participant Flow|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
561674|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
561675|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
561676|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
561677|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
561678|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
561679|NCT00886743|E1|Reported Event|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
561680|NCT00886769|B3|Baseline|Total|Total of all reporting groups
561681|NCT00886769|B2|Baseline|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561682|NCT00886769|B1|Baseline|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561683|NCT00886769|P2|Participant Flow|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561684|NCT00886769|P1|Participant Flow|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561685|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561686|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561687|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561688|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561689|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561690|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561691|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561692|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561693|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561694|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561695|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561696|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561697|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561698|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561699|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561700|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561701|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561702|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561703|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561704|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561705|NCT00886769|E2|Reported Event|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
561706|NCT00886769|E1|Reported Event|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
561707|NCT00886795|B1|Baseline|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.
abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
561708|NCT00886795|P1|Participant Flow|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.
abatacept (Orencia ®): 4 infusions of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks. The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
561709|NCT00886795|O1|Outcome|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.
abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks."
561710|NCT00886795|O1|Outcome|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.
abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
561711|NCT00886795|E1|Reported Event|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.
abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
561712|NCT00886821|B15|Baseline|Total|Total of all reporting groups
561713|NCT00886821|B14|Baseline|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
561714|NCT00886821|B13|Baseline|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561715|NCT00886821|B12|Baseline|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561716|NCT00886821|B11|Baseline|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561717|NCT00886821|B10|Baseline|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or two dose on Day 1 and 8 respectively.
561718|NCT00886821|B9|Baseline|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561719|NCT00886821|B8|Baseline|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561720|NCT00886821|B7|Baseline|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561721|NCT00886821|B6|Baseline|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561722|NCT00886821|B5|Baseline|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561723|NCT00886821|B4|Baseline|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561724|NCT00886821|B3|Baseline|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561725|NCT00886821|B2|Baseline|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561726|NCT00886821|B1|Baseline|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561727|NCT00886821|P14|Participant Flow|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
561728|NCT00886821|P13|Participant Flow|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561729|NCT00886821|P12|Participant Flow|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561730|NCT00886821|P11|Participant Flow|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561731|NCT00886821|P10|Participant Flow|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561732|NCT00886821|P9|Participant Flow|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561733|NCT00886821|P8|Participant Flow|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561734|NCT00886821|P7|Participant Flow|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561735|NCT00886821|P6|Participant Flow|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561736|NCT00886821|P5|Participant Flow|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561737|NCT00886821|P4|Participant Flow|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561738|NCT00886821|P3|Participant Flow|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561739|NCT00886821|P2|Participant Flow|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561740|NCT00886821|P1|Participant Flow|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561741|NCT00886821|O4|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
561742|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561743|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561744|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561745|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561746|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
561747|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561748|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561749|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561750|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561751|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561752|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561753|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561754|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561755|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561756|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561757|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
561758|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561759|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561760|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561761|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561762|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561763|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561764|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561765|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561766|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561767|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561768|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
561769|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561770|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561771|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561772|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561773|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561774|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561775|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561776|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561777|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561778|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
561779|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561780|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561781|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561782|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561783|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
561784|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561785|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561786|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561787|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561788|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561789|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561790|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561791|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561792|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561793|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
561794|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561795|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561796|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561797|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561798|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
561799|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561800|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561801|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561802|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561803|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561804|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561805|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561806|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561807|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561808|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
561809|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561810|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561811|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561812|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561813|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
561814|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561815|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561816|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561817|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561818|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561819|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561820|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561821|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561822|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561823|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
561824|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561825|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561826|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561827|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561828|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
561829|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561830|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561831|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561832|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561833|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561834|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561835|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561836|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561837|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561838|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561839|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
561840|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561841|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561842|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561843|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561844|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561845|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561846|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561847|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561848|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561849|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561850|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
561851|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561852|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561853|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561854|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561855|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561856|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561857|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561858|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561859|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561860|NCT00886821|O14|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
561861|NCT00886821|O13|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561862|NCT00886821|O12|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561863|NCT00886821|O11|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561864|NCT00886821|O10|Outcome|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561865|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561866|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561867|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561868|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561869|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561870|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561871|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561872|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561873|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561874|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561875|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561876|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561877|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561878|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561879|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561880|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561881|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561882|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561883|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561884|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561885|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561886|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561887|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561888|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561889|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561890|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561891|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561892|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561893|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561894|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561895|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561896|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561897|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561898|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561899|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561900|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561901|NCT00886821|O1|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561902|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561903|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561904|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561905|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561906|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561907|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561908|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561909|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561910|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561911|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561912|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561913|NCT00886821|O1|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561914|NCT00886821|O12|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561915|NCT00886821|O11|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561916|NCT00886821|O10|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561917|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561918|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561919|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561920|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561921|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561922|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561923|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561924|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561925|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561926|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561927|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561928|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561929|NCT00886821|O1|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561930|NCT00886821|O12|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561931|NCT00886821|O11|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561932|NCT00886821|O10|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561933|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561934|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561935|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561936|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561937|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561938|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561939|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561940|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561941|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561942|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561943|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561944|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561945|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
561946|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561947|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561948|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561949|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561950|NCT00886821|E14|Reported Event|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
561951|NCT00886821|E13|Reported Event|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
561952|NCT00886821|E12|Reported Event|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
561953|NCT00886821|E11|Reported Event|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
561954|NCT00886821|E10|Reported Event|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
561955|NCT00886821|E9|Reported Event|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
561956|NCT00886821|E8|Reported Event|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
561957|NCT00886821|E7|Reported Event|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
561958|NCT00886821|E6|Reported Event|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
561959|NCT00886821|E5|Reported Event|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
572623|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
561960|NCT00886821|E4|Reported Event|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
561961|NCT00886821|E3|Reported Event|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
561962|NCT00886821|E2|Reported Event|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
561963|NCT00886821|E1|Reported Event|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
561964|NCT00886834|B3|Baseline|Total|Total of all reporting groups
561965|NCT00886834|B2|Baseline|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
561966|NCT00886834|B1|Baseline|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
561967|NCT00886834|P2|Participant Flow|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
561968|NCT00886834|P1|Participant Flow|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
561969|NCT00886834|O2|Outcome|Placebo|
561970|NCT00886834|O1|Outcome|Misoprostol|
561971|NCT00886834|O2|Outcome|Placebo|
561972|NCT00886834|O1|Outcome|Misoprostol|
561973|NCT00886834|E2|Reported Event|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
561974|NCT00886834|E1|Reported Event|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
561975|NCT00886899|B1|Baseline|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
561976|NCT00886899|P1|Participant Flow|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
561977|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
561978|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
561979|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
561980|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
561981|NCT00886899|E1|Reported Event|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
561982|NCT00886938|B1|Baseline|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
561983|NCT00886938|P1|Participant Flow|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
561984|NCT00886938|O1|Outcome|rTMS|rTMS to the left dorsolateral prefrontal cortex for patients with tinnitus
561985|NCT00886938|E1|Reported Event|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
561986|NCT00887159|B4|Baseline|Total|Total of all reporting groups
561987|NCT00887159|B3|Baseline|Arm C (CE+IMC-A12)|"Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
cisplatin: Given IV
etoposide: Given IV"
561988|NCT00887159|B2|Baseline|Arm B (CE+GDC-0449)|"Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
cisplatin: Given IV
etoposide: Given IV"
561989|NCT00887159|B1|Baseline|Arm A (CE)|"Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
cisplatin: Given IV
etoposide: Given IV"
561990|NCT00887159|P3|Participant Flow|Arm C (CE+IMC-A12)|"Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
cisplatin: Given IV
etoposide: Given IV"
561991|NCT00887159|P2|Participant Flow|Arm B (CE+GDC-0449)|"Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
cisplatin: Given IV
etoposide: Given IV"
561992|NCT00887159|P1|Participant Flow|Arm A (CE)|"Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
cisplatin: Given IV
etoposide: Given IV"
561993|NCT00887159|O2|Outcome|Low CTC Count|Low CTC count is defined as <= 100 CTCs per 7.5 ml at baseline.
561994|NCT00887159|O1|Outcome|High CTC Count|High CTC count is defined as greater than 100 CTCs per 7.5 ml at baseline.
561995|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
562018|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
561996|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
561997|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
561998|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
561999|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
562000|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
562001|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
562002|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
562003|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
562004|NCT00887159|E3|Reported Event|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
562005|NCT00887159|E2|Reported Event|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
562006|NCT00887159|E1|Reported Event|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
562007|NCT00887198|B3|Baseline|Total|Total of all reporting groups
562008|NCT00887198|B2|Baseline|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562009|NCT00887198|B1|Baseline|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562010|NCT00887198|P2|Participant Flow|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562011|NCT00887198|P1|Participant Flow|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562012|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562013|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562014|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562015|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562016|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562017|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562019|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562020|NCT00887198|O3|Outcome|Placebo to Abiraterone Acetate|Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
562021|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562022|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562023|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562024|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562025|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562026|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562027|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562028|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562029|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562030|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562031|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562032|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562033|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562034|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562035|NCT00887198|E3|Reported Event|Placebo to Abiraterone Acetate|Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
562036|NCT00887198|E2|Reported Event|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562037|NCT00887198|E1|Reported Event|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
562038|NCT00887224|B4|Baseline|Total|Total of all reporting groups
562039|NCT00887224|B3|Baseline|DVS SR 50 mg (Double-blind Phase)|"Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population)."
562040|NCT00887224|B2|Baseline|Placebo (Double-blind Phase)|"Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population)."
562070|NCT00887250|B2|Baseline|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
562071|NCT00887250|B1|Baseline|Placebo|Losartan placebo orally once daily for 12 weeks
572624|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
562041|NCT00887224|B1|Baseline|DVS SR 50 mg (Open-label Phase)|DVS SR 50 mg PO QD for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
562042|NCT00887224|P3|Participant Flow|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population).
562043|NCT00887224|P2|Participant Flow|Placebo (Double-blind Phase)|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population).
562044|NCT00887224|P1|Participant Flow|DVS SR 50 mg (Open-label Phase)|Desvenlafaxine succinate sustained release (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
562045|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
562046|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
562047|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
562048|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
562049|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
562050|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
562051|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
562052|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
562053|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
562054|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
562055|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
562056|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
562057|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD..
562058|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
562059|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
562060|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
562061|NCT00887224|E7|Reported Event|DVS SR 50 mg (DB Taper / DB Post Study Follow Up)|Participants who concluded or discontinued DVS SR 50 mg during the DB phase could have entered the taper phase and received DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
562062|NCT00887224|E6|Reported Event|Placebo (DB Taper / DB Post Study Follow Up)|Participants who concluded or discontinued placebo during the DB phase could have entered the taper phase and received placebo matching DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
562063|NCT00887224|E5|Reported Event|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
562064|NCT00887224|E4|Reported Event|Placebo (Double-blind Phase)|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
562065|NCT00887224|E3|Reported Event|DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up)|Participants who concluded DVS SR 50 mg open-label study or discontinued treatment at any time in OLR or OLS could have entered the taper phase and received DVS SR 25 mg PO QD for a 7-day period of taper treatment. N=number of participants with OL Taper or OL Post Study Follow Up emergent events who did not enter the DB Phase and concluded or discontinued with or without taper treatment.
562066|NCT00887224|E2|Reported Event|DVS SR 50 mg (Open Label Stability Phase)|DVS SR 50 mg PO QD; Responders at week 8 entered a 12-week stability phase.
562067|NCT00887224|E1|Reported Event|DVS SR 50 mg (Open-label Response Phase)|DVS SR 50 mg PO QD for 8 weeks.
562068|NCT00887250|B4|Baseline|Total|Total of all reporting groups
562069|NCT00887250|B3|Baseline|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
562072|NCT00887250|P3|Participant Flow|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
562073|NCT00887250|P2|Participant Flow|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
562074|NCT00887250|P1|Participant Flow|Placebo|Losartan placebo orally once daily for 12 weeks
562075|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
562076|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
562077|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562078|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
562079|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
562080|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562081|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
562082|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
562083|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562084|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
562085|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
562086|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562087|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
562088|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
562089|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562090|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
562091|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
562092|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562093|NCT00887289|B1|Baseline|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
562094|NCT00887289|P1|Participant Flow|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
562095|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
562096|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
562097|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
562098|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
562099|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
562100|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
562101|NCT00887289|E1|Reported Event|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
562102|NCT00887315|B3|Baseline|Total|Total of all reporting groups
562103|NCT00887315|B2|Baseline|Chemo and Radiation|Chemotherapy and radiotherapy
562104|NCT00887315|B1|Baseline|Chemo Only|Chemotherapy only
562105|NCT00887315|P2|Participant Flow|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
562106|NCT00887315|P1|Participant Flow|Chemo Only|Chemotherapy only
562107|NCT00887315|O2|Outcome|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
562108|NCT00887315|O1|Outcome|Chemo Only|Chemotherapy only
562109|NCT00887315|O2|Outcome|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
562110|NCT00887315|O1|Outcome|Chemo Only|Chemotherapy only
562111|NCT00887315|E2|Reported Event|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
562112|NCT00887315|E1|Reported Event|Chemo Only|Chemotherapy only
562113|NCT00887341|B3|Baseline|Total|Total of all reporting groups
562114|NCT00887341|B2|Baseline|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562115|NCT00887341|B1|Baseline|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562116|NCT00887341|P2|Participant Flow|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562117|NCT00887341|P1|Participant Flow|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562118|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562119|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562169|NCT00887354|E2|Reported Event|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562120|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562121|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562122|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562123|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562124|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562125|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562126|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562127|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562128|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562129|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562130|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562131|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562132|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562133|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562134|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562135|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562136|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562137|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562138|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562139|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562140|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562141|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562142|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562143|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562211|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562144|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562145|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562146|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562147|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562148|NCT00887341|E2|Reported Event|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
562149|NCT00887341|E1|Reported Event|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
562150|NCT00887354|B3|Baseline|Total|Total of all reporting groups
562151|NCT00887354|B2|Baseline|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562152|NCT00887354|B1|Baseline|Teriparatide|"20 mcg a day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562153|NCT00887354|P2|Participant Flow|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562154|NCT00887354|P1|Participant Flow|Teriparatide|"20 microgram (mcg) a day by subcutaneous (SC) injection throughout study.
Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562155|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562156|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562157|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562158|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562159|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562160|NCT00887354|O1|Outcome|Teriparatide|"20 mg per day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562161|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562162|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562163|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562164|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562165|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562166|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562167|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562168|NCT00887354|O1|Outcome|Teriparatide|"20 mg per day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562210|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
572625|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
562170|NCT00887354|E1|Reported Event|Teriparatide|"20 mcg a day by SC injection throughout study.
Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
562171|NCT00887458|B3|Baseline|Total|Total of all reporting groups
562172|NCT00887458|B2|Baseline|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
562173|NCT00887458|B1|Baseline|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)
Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
562174|NCT00887458|P2|Participant Flow|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
562175|NCT00887458|P1|Participant Flow|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)
Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
562176|NCT00887458|O2|Outcome|High Dose Itraconazole|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
562177|NCT00887458|O1|Outcome|Low Dose Itraconazole|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)
Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
562178|NCT00887458|E2|Reported Event|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
562179|NCT00887458|E1|Reported Event|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)
Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
562180|NCT00887471|B3|Baseline|Total|Total of all reporting groups
562181|NCT00887471|B2|Baseline|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
562182|NCT00887471|B1|Baseline|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
562183|NCT00887471|P2|Participant Flow|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
562184|NCT00887471|P1|Participant Flow|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
562185|NCT00887471|O2|Outcome|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
562186|NCT00887471|O1|Outcome|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
562187|NCT00887471|O2|Outcome|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
562188|NCT00887471|O1|Outcome|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
562189|NCT00887471|E2|Reported Event|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
562190|NCT00887471|E1|Reported Event|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
562191|NCT00887484|B1|Baseline|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
562192|NCT00887484|P1|Participant Flow|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
562193|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
562194|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562195|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562196|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
562197|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562198|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562199|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
562200|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562201|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562202|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
562203|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562204|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562205|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
562206|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562207|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562208|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
562209|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562212|NCT00887484|O1|Outcome|All Subjects|Subjects applied both study products in a split-face fashion through week 2. Study products were applied once-daily in the evening.
562213|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562214|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562215|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562216|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562217|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562218|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562219|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562220|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562221|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562222|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562223|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562224|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562225|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562226|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562227|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562228|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562229|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562230|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562231|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562232|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562233|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562234|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562235|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562236|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562237|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562238|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562239|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562240|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562241|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562242|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562243|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562244|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562245|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562246|NCT00887484|O2|Outcome|Epiduo|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562247|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562248|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562249|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562250|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562251|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
562252|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562253|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
562254|NCT00887484|E1|Reported Event|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
562255|NCT00887510|B3|Baseline|Total|Total of all reporting groups
562256|NCT00887510|B2|Baseline|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
562257|NCT00887510|B1|Baseline|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
562258|NCT00887510|P2|Participant Flow|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
562259|NCT00887510|P1|Participant Flow|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
562260|NCT00887510|O2|Outcome|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
562261|NCT00887510|O1|Outcome|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
562262|NCT00887510|O2|Outcome|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
562263|NCT00887510|O1|Outcome|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
562264|NCT00887510|E2|Reported Event|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
562265|NCT00887510|E1|Reported Event|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
562266|NCT00887549|B1|Baseline|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
562267|NCT00887549|P1|Participant Flow|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
562268|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
562269|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
562270|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
562271|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
562272|NCT00887549|E1|Reported Event|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
562273|NCT00887562|B4|Baseline|Total|Total of all reporting groups
562274|NCT00887562|B3|Baseline|Placebo|"Placebo
Placebo: Placebo - No idebenone"
562275|NCT00887562|B2|Baseline|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day
Idebenone: 2250 mg/day for one month"
562276|NCT00887562|B1|Baseline|Idebenone 900 mg/Day|"Idebenone 900 mg/day
Idebenone: 900 mg/day for 1 month"
562277|NCT00887562|P3|Participant Flow|Placebo|"Placebo
Placebo: Placebo - No idebenone"
562278|NCT00887562|P2|Participant Flow|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day
Idebenone: 2250 mg/day for one month"
562279|NCT00887562|P1|Participant Flow|Idebenone 900 mg/Day|"Idebenone 900 mg/day
Idebenone: 900 mg/day for 1 month"
562280|NCT00887562|O3|Outcome|Placebo|"Placebo
Placebo: Placebo - No idebenone"
562281|NCT00887562|O2|Outcome|2250 mg/Day|"Idebenone 2250 mg/day
Idebenone: 2250 mg/day for one month"
562282|NCT00887562|O1|Outcome|900 mg/Day|"Idebenone 900 mg/day
Idebenone: 900 mg/day for 1 month"
562283|NCT00887562|O3|Outcome|Placebo|"Placebo
Placebo: Placebo - No idebenone"
562284|NCT00887562|O2|Outcome|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day
Idebenone: 2250 mg/day for one month"
562285|NCT00887562|O1|Outcome|Idebenone 900 mg/Day|"Idebenone 900 mg/day
Idebenone: 900 mg/day for 1 month"
562286|NCT00887562|O3|Outcome|Placebo|"Placebo
Placebo: Placebo - No idebenone"
562287|NCT00887562|O2|Outcome|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day
Idebenone: 2250 mg/day for one month"
562288|NCT00887562|O1|Outcome|Idebenone 900 mg/Day|"Idebenone 900 mg/day
Idebenone: 900 mg/day for 1 month"
562289|NCT00887562|E3|Reported Event|Placebo|"Placebo
Placebo: Placebo - No idebenone"
562290|NCT00887562|E2|Reported Event|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day
Idebenone: 2250 mg/day for one month"
562291|NCT00887562|E1|Reported Event|Idebenone 900 mg/Day|"Idebenone 900 mg/day
Idebenone: 900 mg/day for 1 month"
562292|NCT00887575|B1|Baseline|All Patients|Includes all patients treated at all dose levels
562293|NCT00887575|P3|Participant Flow|Dose Level III|Paclitaxel IV (80 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 6) day 1 of every cycle and Sunitinib PO (25mg) daily.
562294|NCT00887575|P2|Participant Flow|Dose Level II|Paclitaxel IV (80 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.
562295|NCT00887575|P1|Participant Flow|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.
Maintenance - Sunitinib PO (25mg) daily"
562296|NCT00887575|O1|Outcome|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.
Maintenance - Sunitinib PO (25mg) daily"
562297|NCT00887575|O1|Outcome|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.
Maintenance - Sunitinib PO (25mg) daily"
562298|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
562299|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
562300|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
562301|NCT00887575|E1|Reported Event|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.
Maintenance - Sunitinib PO (25mg) daily"
562302|NCT00887588|B3|Baseline|Total|Total of all reporting groups
562303|NCT00887588|B2|Baseline|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562304|NCT00887588|B1|Baseline|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562305|NCT00887588|P2|Participant Flow|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562306|NCT00887588|P1|Participant Flow|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562307|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562308|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562309|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562310|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562311|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562312|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562313|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562314|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562315|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562316|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562317|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562318|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562462|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562319|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562320|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562321|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562322|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562323|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562324|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562325|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562326|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562327|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562328|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562329|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562330|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562331|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562332|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562333|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562334|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562335|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562336|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562337|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562338|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562339|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562340|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562341|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562342|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562343|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562344|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562345|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562346|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562347|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562348|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562349|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562350|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562351|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562352|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562353|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562354|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562355|NCT00887588|E2|Reported Event|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
562356|NCT00887588|E1|Reported Event|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
562357|NCT00887640|B1|Baseline|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562358|NCT00887640|P1|Participant Flow|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562359|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562360|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562361|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562362|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562363|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562364|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562365|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562366|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562367|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562368|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562369|NCT00887640|E1|Reported Event|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
562370|NCT00887653|B1|Baseline|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months
raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
562371|NCT00887653|P1|Participant Flow|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months
raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
562372|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months
raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
562373|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months
raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
562374|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months
raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
562375|NCT00887653|E1|Reported Event|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months
raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
562376|NCT00887679|B1|Baseline|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
562377|NCT00887679|P1|Participant Flow|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
562378|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
562379|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
562380|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
562381|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
562382|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
562383|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Subjects received escitalopram 10-20mg. Escitalopram was started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day.
562384|NCT00887679|E1|Reported Event|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
562385|NCT00887744|B1|Baseline|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
562463|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562386|NCT00887744|P1|Participant Flow|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication.
562387|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
562388|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
562389|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
562390|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
562391|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
562392|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
562393|NCT00887744|E1|Reported Event|ITT Analysis|Single group - Aperius
562394|NCT00887809|B3|Baseline|Total|Total of all reporting groups
562395|NCT00887809|B2|Baseline|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
562396|NCT00887809|B1|Baseline|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
562397|NCT00887809|P2|Participant Flow|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
562398|NCT00887809|P1|Participant Flow|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
562399|NCT00887809|O2|Outcome|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
562400|NCT00887809|O1|Outcome|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
562401|NCT00887809|E2|Reported Event|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
562402|NCT00887809|E1|Reported Event|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
562403|NCT00887822|B3|Baseline|Total|Total of all reporting groups
562404|NCT00887822|B2|Baseline|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562405|NCT00887822|B1|Baseline|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562406|NCT00887822|P2|Participant Flow|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562407|NCT00887822|P1|Participant Flow|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562408|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562409|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562410|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562464|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562465|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562411|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562412|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562413|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562414|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562415|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562416|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562417|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562418|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562419|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562420|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562421|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562422|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562423|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562424|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562425|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562426|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562427|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562466|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562428|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562429|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562430|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562431|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562432|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562433|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562434|NCT00887822|E2|Reported Event|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562435|NCT00887822|E1|Reported Event|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
562436|NCT00887913|B1|Baseline|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
562437|NCT00887913|P1|Participant Flow|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
562438|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
562439|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
562440|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
562441|NCT00887913|E1|Reported Event|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
562442|NCT00887965|B1|Baseline|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562443|NCT00887965|P1|Participant Flow|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562444|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562445|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562446|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562447|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562448|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562449|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562450|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562451|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562452|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562453|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562454|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562455|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562456|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562457|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562458|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562459|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562460|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562461|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562467|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562468|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562469|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562470|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562471|NCT00887965|E1|Reported Event|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
562472|NCT00887978|B3|Baseline|Total|Total of all reporting groups
562473|NCT00887978|B2|Baseline|Placebo|Identical placebo tablets to UT-15C, doses were titrated in the same manner
562474|NCT00887978|B1|Baseline|UT-15C SR|Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
562475|NCT00887978|P2|Participant Flow|Placebo|Identical placebo tablets to UT-15C, doses were titrated in the same manner
562476|NCT00887978|P1|Participant Flow|UT-15C SR|Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
562477|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562478|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562479|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562480|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562481|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562482|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562483|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562484|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562485|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562486|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562487|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562488|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562489|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562490|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562491|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562492|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562493|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562494|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562495|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562496|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562497|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562498|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562499|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562500|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562501|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562502|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562503|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562504|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562505|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562506|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562507|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
562508|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
562509|NCT00887978|E2|Reported Event|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1 (3.6).
562510|NCT00887978|E1|Reported Event|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1 (1.9).
562511|NCT00881335|B3|Baseline|Total|Total of all reporting groups
562512|NCT00881335|B2|Baseline|Control Group|without any intervention
562513|NCT00881335|B1|Baseline|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
562514|NCT00881335|P2|Participant Flow|Control Group|without any intervention
562515|NCT00881335|P1|Participant Flow|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
562516|NCT00881335|O2|Outcome|Control Group|without any intervention
562517|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
562518|NCT00881335|O2|Outcome|Control Group|without any intervention
562519|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
562520|NCT00881335|O2|Outcome|Control Group|without any intervention
562521|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
562522|NCT00881335|O2|Outcome|Control Group|without any intervention
562523|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
562524|NCT00881335|O2|Outcome|Control Group|without any intervention
562525|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
562527|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
562528|NCT00881335|O2|Outcome|Control Group|without any intervention
562529|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
562530|NCT00881335|E2|Reported Event|Control Group|without any intervention
562531|NCT00881335|E1|Reported Event|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
562532|NCT00881465|B3|Baseline|Total|Total of all reporting groups
562533|NCT00881465|B2|Baseline|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
562534|NCT00881465|B1|Baseline|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.
Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
562535|NCT00881465|P2|Participant Flow|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
562536|NCT00881465|P1|Participant Flow|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.
Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
562537|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
562538|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.
Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
562539|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
562540|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.
Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
562541|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
562542|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.
Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
562543|NCT00881465|E2|Reported Event|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
562569|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562777|NCT00882440|P5|Participant Flow|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
562544|NCT00881465|E1|Reported Event|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.
Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
562545|NCT00881504|B1|Baseline|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab
Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
562546|NCT00881504|P1|Participant Flow|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab
Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
562547|NCT00881504|O1|Outcome|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab
Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
562548|NCT00881504|O1|Outcome|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab
Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
562549|NCT00881504|E1|Reported Event|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab
Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
562550|NCT00881530|B7|Baseline|Total|Total of all reporting groups
562551|NCT00881530|B6|Baseline|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562552|NCT00881530|B5|Baseline|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562553|NCT00881530|B4|Baseline|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562554|NCT00881530|B3|Baseline|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
562555|NCT00881530|B2|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
562556|NCT00881530|B1|Baseline|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
562557|NCT00881530|P6|Participant Flow|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562558|NCT00881530|P5|Participant Flow|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562559|NCT00881530|P4|Participant Flow|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562560|NCT00881530|P3|Participant Flow|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
562561|NCT00881530|P2|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
562562|NCT00881530|P1|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
562563|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562564|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562565|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562566|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
562567|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
562568|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
562778|NCT00882440|P4|Participant Flow|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
562570|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562571|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562572|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
562573|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
562574|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
562575|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562576|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562577|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562578|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
562579|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
562580|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
562581|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562582|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562583|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562584|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
562585|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
562586|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
562587|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562588|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562589|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562590|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
562591|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
562592|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
562593|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562594|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562595|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562596|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
562597|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
562598|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
562599|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562779|NCT00882440|P3|Participant Flow|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
562600|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562601|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562602|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
562603|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
562604|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
562605|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562606|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562607|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562608|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
562609|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
562610|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
562611|NCT00881530|E6|Reported Event|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562612|NCT00881530|E5|Reported Event|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562613|NCT00881530|E4|Reported Event|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
562614|NCT00881530|E3|Reported Event|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
562615|NCT00881530|E2|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
562616|NCT00881530|E1|Reported Event|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
562617|NCT00881608|B6|Baseline|Total|Total of all reporting groups
562618|NCT00881608|B5|Baseline|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562619|NCT00881608|B4|Baseline|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562620|NCT00881608|B3|Baseline|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562621|NCT00881608|B2|Baseline|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562622|NCT00881608|B1|Baseline|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Placebo: Placebo, 1 capsule daily for five days"
562623|NCT00881608|P1|Participant Flow|All Subjects Enrolled|All subjects initiated treatment with placebo. Further information is not availasble due to premature termination of the study.
562624|NCT00881608|O5|Outcome|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562625|NCT00881608|O4|Outcome|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562626|NCT00881608|O3|Outcome|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562627|NCT00881608|O2|Outcome|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562628|NCT00881608|O1|Outcome|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Placebo: Placebo, 1 capsule daily for five days"
562629|NCT00881608|O5|Outcome|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562630|NCT00881608|O4|Outcome|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562631|NCT00881608|O3|Outcome|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562632|NCT00881608|O2|Outcome|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562633|NCT00881608|O1|Outcome|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Placebo: Placebo, 1 capsule daily for five days"
562634|NCT00881608|E5|Reported Event|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562635|NCT00881608|E4|Reported Event|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562636|NCT00881608|E3|Reported Event|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562637|NCT00881608|E2|Reported Event|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
562638|NCT00881608|E1|Reported Event|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Placebo: Placebo, 1 capsule daily for five days"
562639|NCT00881621|B1|Baseline|Lapatinib and Capecitabine|"Treatment
Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
562640|NCT00881621|P1|Participant Flow|Lapatinib and Capecitabine|"Treatment
Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
562641|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment
Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
562642|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment
Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
562643|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment
Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
562644|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment
Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
562645|NCT00881621|E1|Reported Event|Lapatinib and Capecitabine|"Treatment
Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
562646|NCT00881647|B3|Baseline|Total|Total of all reporting groups
562647|NCT00881647|B2|Baseline|Waitlist|Participants placed on a waitlist for 8 weeks.
562648|NCT00881647|B1|Baseline|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
562649|NCT00881647|P2|Participant Flow|Waitlist|Participants placed on a waitlist for 8 weeks.
562650|NCT00881647|P1|Participant Flow|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
562651|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
562652|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
562653|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
562654|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
562655|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
562656|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
562657|NCT00881647|E2|Reported Event|Waitlist|Participants placed on a waitlist for 8 weeks.
562658|NCT00881647|E1|Reported Event|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
562659|NCT00881712|B4|Baseline|Total|Total of all reporting groups
562723|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562660|NCT00881712|B3|Baseline|Patients Considered Resectable|"Proton radiation plus surgery
Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
562661|NCT00881712|B2|Baseline|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation
PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
562662|NCT00881712|B1|Baseline|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy
PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
562663|NCT00881712|P3|Participant Flow|Patients Considered Resectable|"Proton radiation plus surgery
Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
562664|NCT00881712|P2|Participant Flow|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation
PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
562665|NCT00881712|P1|Participant Flow|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy
PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
562666|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery
Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
562667|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation
PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
562668|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy
PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
562669|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery
Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
562670|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation
PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
562671|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy
PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
562672|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery
Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
562673|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation
PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
562674|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy
PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
562675|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery
Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
562676|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation
PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
562677|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy
PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
562678|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery
Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
562679|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation
PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
562680|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy
PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
562681|NCT00881712|E3|Reported Event|Patients Considered Resectable|"Proton radiation plus surgery
Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
562682|NCT00881712|E2|Reported Event|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation
PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
562683|NCT00881712|E1|Reported Event|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy
PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
562684|NCT00881868|B3|Baseline|Total|Total of all reporting groups
562685|NCT00881868|B2|Baseline|Vehicle Spray|
562686|NCT00881868|B1|Baseline|Clobex Spray|
562687|NCT00881868|P2|Participant Flow|Vehicle Spray|
562688|NCT00881868|P1|Participant Flow|Clobex Spray|
562689|NCT00881868|O2|Outcome|Vehicle Spray|
562690|NCT00881868|O1|Outcome|Clobex Spray|
562691|NCT00881868|O2|Outcome|Vehicle Spray|
562692|NCT00881868|O1|Outcome|Clobex Spray|
562693|NCT00881868|O2|Outcome|Vehicle Spray|
562694|NCT00881868|O1|Outcome|Clobex Spray|
562695|NCT00881868|O2|Outcome|Vehicle Spray|
562696|NCT00881868|O1|Outcome|Clobex Spray|
562697|NCT00881868|E2|Reported Event|Vehicle Spray|
562698|NCT00881868|E1|Reported Event|Clobex Spray|
562699|NCT00881894|B3|Baseline|Total|Total of all reporting groups
562700|NCT00881894|B2|Baseline|Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)|Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days
562701|NCT00881894|B1|Baseline|Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)|Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days
562702|NCT00881894|P2|Participant Flow|Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)|Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days
562703|NCT00881894|P1|Participant Flow|Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)|Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days
562704|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562705|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562706|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562707|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562708|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562709|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562710|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562711|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562712|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562713|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562714|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562715|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562716|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562717|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562718|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562719|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562720|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562721|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562722|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562769|NCT00882440|B6|Baseline|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
572626|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
562724|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562725|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562726|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562727|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562728|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562729|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562730|NCT00881894|E2|Reported Event|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
562731|NCT00881894|E1|Reported Event|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
562732|NCT00881959|B3|Baseline|Total|Total of all reporting groups
562733|NCT00881959|B2|Baseline|Group 2: Alloderm|"Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.
Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"
562734|NCT00881959|B1|Baseline|Group 1: Puros Dermis|"Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.
Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"
562735|NCT00881959|P2|Participant Flow|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
562736|NCT00881959|P1|Participant Flow|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
562737|NCT00881959|O2|Outcome|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
562738|NCT00881959|O1|Outcome|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
562739|NCT00881959|E2|Reported Event|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
562740|NCT00881959|E1|Reported Event|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
562741|NCT00882102|B1|Baseline|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
562742|NCT00882102|P1|Participant Flow|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
562743|NCT00882102|O1|Outcome|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 by vein over 1-1/2 hours daily for 5 days. Gemtuzumab ozogamicin 3 mg/m^2 by vein on day 5.
562744|NCT00882102|E1|Reported Event|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
562745|NCT00882206|B1|Baseline|Decitabine / Vorinostat|This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
562746|NCT00882206|P1|Participant Flow|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.
*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.
decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour
doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes
imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.
methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.
pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)
prednisone: 40mg/m2/day divided BID (days 5 – 33)
vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
562747|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.
*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.
decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour
doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes
imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.
methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.
pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)
prednisone: 40mg/m2/day divided BID (days 5 – 33)
vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
562770|NCT00882440|B5|Baseline|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
562771|NCT00882440|B4|Baseline|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
562772|NCT00882440|B3|Baseline|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
562773|NCT00882440|B2|Baseline|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
562774|NCT00882440|B1|Baseline|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
562775|NCT00882440|P7|Participant Flow|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
562776|NCT00882440|P6|Participant Flow|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
562748|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.
*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.
decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour
doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes
imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.
methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.
pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)
prednisone: 40mg/m2/day divided BID (days 5 – 33)
vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
562749|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.
*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.
decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour
doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes
imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.
methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.
pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)
prednisone: 40mg/m2/day divided BID (days 5 – 33)
vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
562750|NCT00882206|O1|Outcome|Decitabine / Vorinostat|This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
562751|NCT00882206|E1|Reported Event|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.
*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.
decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour
doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes
imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.
methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.
pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)
prednisone: 40mg/m2/day divided BID (days 5 – 33)
vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12)"
562752|NCT00882310|B1|Baseline|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
562753|NCT00882310|P1|Participant Flow|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
562754|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
562755|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
562756|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
562757|NCT00882310|E1|Reported Event|Gemcitabine, Docetaxel, Capecitabine GTX|"GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
AE data was collected on 26 subjects (out of 37 subjects, 10 were screen failures and 1 was not treated)."
562758|NCT00882362|B3|Baseline|Total|Total of all reporting groups
562759|NCT00882362|B2|Baseline|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
562760|NCT00882362|B1|Baseline|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
562761|NCT00882362|P2|Participant Flow|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
562762|NCT00882362|P1|Participant Flow|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
562763|NCT00882362|O2|Outcome|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
562764|NCT00882362|O1|Outcome|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
562765|NCT00882362|E2|Reported Event|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
562766|NCT00882362|E1|Reported Event|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
562767|NCT00882440|B8|Baseline|Total|Total of all reporting groups
562768|NCT00882440|B7|Baseline|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
572627|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
562780|NCT00882440|P2|Participant Flow|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
562781|NCT00882440|P1|Participant Flow|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
562782|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
562783|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
562784|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
562785|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
562786|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
562787|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
562788|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
562789|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
562790|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
562791|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
562792|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
562793|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
562794|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
562795|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
562796|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
562797|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
562798|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
562799|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
562800|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
562801|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
562802|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
562803|NCT00882518|B3|Baseline|Total|Total of all reporting groups
562804|NCT00882518|B2|Baseline|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion. Full analysis set (FAS) population used for baseline characteristics
562805|NCT00882518|B1|Baseline|Seroquel_XR|Quetiapine fumarate XR was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion. Full analysis set (FAS) population used for baseline characteristics
562806|NCT00882518|P2|Participant Flow|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion.
562807|NCT00882518|P1|Participant Flow|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion.
562808|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
562809|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
562810|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
562811|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
562812|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
562813|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
562814|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
562840|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
562841|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
562815|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
562816|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
562817|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
562818|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
562819|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
562820|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
562821|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
562822|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
562823|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
562824|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
562825|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
562826|NCT00882518|E2|Reported Event|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion.
562827|NCT00882518|E1|Reported Event|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion.
562828|NCT00882557|B3|Baseline|Total|Total of all reporting groups
562829|NCT00882557|B2|Baseline|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
562830|NCT00882557|B1|Baseline|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
562831|NCT00882557|P2|Participant Flow|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
562832|NCT00882557|P1|Participant Flow|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
562833|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
562834|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
562835|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
562836|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
562837|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
562838|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
562839|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
562911|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562842|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
562843|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
562844|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
562845|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
562846|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
562847|NCT00882557|E2|Reported Event|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
562848|NCT00882557|E1|Reported Event|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
562849|NCT00882583|B3|Baseline|Total|Total of all reporting groups
562850|NCT00882583|B2|Baseline|Cohort B|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.
Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.
Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8
Dasatinib: Oral Dasatinib Days 8 through 64.
Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days
Radiation Therapy: Standard Radiation Therapy."
562851|NCT00882583|B1|Baseline|Cohort A|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.
Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).
Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8
Dasatinib: Oral Dasatinib Days 8 through 64.
Radiation Therapy: Standard Radiation Therapy."
562852|NCT00882583|P2|Participant Flow|Cohort B T3N0-1,T1-4N2-3M0, T4N0-1M0 SCCHN|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.
Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma (SCC) of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.
Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8
Dasatinib: Oral Dasatinib Days 8 through 64.
Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days
Radiation Therapy: Standard Radiation Therapy."
562853|NCT00882583|P1|Participant Flow|Cohort A T2N0, T1-2N1 SCCHN|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.
Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).
Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8
Dasatinib: Oral Dasatinib Days 8 through 64.
Radiation Therapy: Standard Radiation Therapy."
562854|NCT00882583|O2|Outcome|Cohort B|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.
Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.
Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8
Dasatinib: Oral Dasatinib Days 8 through 64.
Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days
Radiation Therapy: Standard Radiation Therapy."
562855|NCT00882583|O1|Outcome|Cohort A|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.
Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).
Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8
Dasatinib: Oral Dasatinib Days 8 through 64.
Radiation Therapy: Standard Radiation Therapy."
562856|NCT00882583|E2|Reported Event|Cohort B|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.
Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.
Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8
Dasatinib: Oral Dasatinib Days 8 through 64.
Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days
Radiation Therapy: Standard Radiation Therapy."
562857|NCT00882583|E1|Reported Event|Cohort A|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.
Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).
Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8
Dasatinib: Oral Dasatinib Days 8 through 64.
Radiation Therapy: Standard Radiation Therapy."
562858|NCT00888134|B1|Baseline|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
562910|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562859|NCT00888134|P1|Participant Flow|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
562860|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
562861|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Selumetinib: Given PO"
562862|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
562863|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
562864|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
562865|NCT00888134|E1|Reported Event|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO"
562866|NCT00888238|B1|Baseline|All Patients|All Randomized patients
562867|NCT00888238|P3|Participant Flow|Placebo / Sitagliptin / Sitagliptin|Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
562868|NCT00888238|P2|Participant Flow|Sitagliptin / Placebo / Sitagliptin|Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
562869|NCT00888238|P1|Participant Flow|Sitagliptin / Sitagliptin / Placebo|Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo
562870|NCT00888238|O2|Outcome|Placebo|12 subjects received a single-dose of placebo in 1 period.
562871|NCT00888238|O1|Outcome|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
562872|NCT00888238|O2|Outcome|Placebo|12 subjects received a single-dose of placebo in 1 period.
562873|NCT00888238|O1|Outcome|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
562874|NCT00888238|E2|Reported Event|Placebo|12 subjects received a single-dose of placebo in 1 period.
562875|NCT00888238|E1|Reported Event|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
562876|NCT00888329|B3|Baseline|Total|Total of all reporting groups
562877|NCT00888329|B2|Baseline|Placebo|Placebo
562878|NCT00888329|B1|Baseline|Aprepitant|40 mg aprepitant
562879|NCT00888329|P2|Participant Flow|Placebo|Placebo
562880|NCT00888329|P1|Participant Flow|Aprepitant|40 mg aprepitant
562881|NCT00888329|O2|Outcome|Placebo|Placebo
562882|NCT00888329|O1|Outcome|Aprepitant|40 mg aprepitant
562883|NCT00888329|E2|Reported Event|Placebo|Placebo
562884|NCT00888329|E1|Reported Event|Aprepitant|40 mg aprepitant
562885|NCT00888355|B5|Baseline|Total|Total of all reporting groups
562886|NCT00888355|B4|Baseline|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562887|NCT00888355|B3|Baseline|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562888|NCT00888355|B2|Baseline|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562889|NCT00888355|B1|Baseline|Placebo|Losartan placebo orally once daily for 12 weeks
562890|NCT00888355|P4|Participant Flow|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562891|NCT00888355|P3|Participant Flow|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562892|NCT00888355|P2|Participant Flow|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562893|NCT00888355|P1|Participant Flow|Placebo|Losartan placebo orally once daily for 12 weeks
562894|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562895|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562896|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562897|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562898|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562899|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562900|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562901|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562902|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562903|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562904|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562905|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562906|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562907|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562908|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562909|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
563061|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
562912|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562913|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562914|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562915|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562916|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562917|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562918|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562919|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562920|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562921|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562922|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562923|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562924|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562925|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562926|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562927|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562928|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562929|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562930|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562931|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562932|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562933|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562934|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562935|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562936|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562937|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562938|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562939|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562940|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562941|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562942|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
562943|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
562944|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
562945|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
562946|NCT00888381|B3|Baseline|Total|Total of all reporting groups
562947|NCT00888381|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older
562948|NCT00888381|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years
562949|NCT00888381|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older
562950|NCT00888381|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years
562951|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
562952|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
562953|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
562954|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
562955|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
562956|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
562957|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
562958|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
562959|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
562960|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
562961|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
562962|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
562963|NCT00888381|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older
562964|NCT00888381|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years
562965|NCT00888628|B1|Baseline|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.
For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.
Induction therapy for subsequent transplants will be 2 doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.
Etanercept: Given as induction for islet cell transplant"
562966|NCT00888628|P1|Participant Flow|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.
For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.
Induction therapy for subsequent transplants will be 2 doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.
Etanercept: Given as induction for islet cell transplant"
563062|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
562967|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.
For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.
Induction therapy for subsequent transplants will be 2 doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.
Etanercept: Given as induction for islet cell transplant"
562968|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.
For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.
Induction therapy for subsequent transplants will be 2 doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.
Etanercept: Given as induction for islet cell transplant"
562969|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.
For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.
Induction therapy for subsequent transplants will be 2 doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.
Etanercept: Given as induction for islet cell transplant"
562970|NCT00888628|E1|Reported Event|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.
For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.
Induction therapy for subsequent transplants will be 2 doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.
Etanercept: Given as induction for islet cell transplant"
562971|NCT00888654|B1|Baseline|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Radical Prostatectomy
B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Radical Prosatectomy"
562972|NCT00888654|P1|Participant Flow|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Radical Prostatectomy
B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Radical Prosatectomy"
562973|NCT00888654|O1|Outcome|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Radical Prostatectomy
B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Radical Prosatectomy"
562974|NCT00888654|E1|Reported Event|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Radical Prostatectomy
B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Radical Prosatectomy"
562975|NCT00888849|B3|Baseline|Total|Total of all reporting groups
562976|NCT00888849|B2|Baseline|Suturing|4 layered hand-sutured anastomosis
562977|NCT00888849|B1|Baseline|Stapling|
562978|NCT00888849|P2|Participant Flow|Suturing|4 layered hand-sutured anastomosis
562979|NCT00888849|P1|Participant Flow|Stapling|
562980|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
562981|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
562982|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
562983|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
562984|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
562985|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
562986|NCT00888849|E2|Reported Event|Suturing|4 layered hand-sutured anastomosis
562987|NCT00888849|E1|Reported Event|Stapling|
562988|NCT00888940|B3|Baseline|Total|Total of all reporting groups
562989|NCT00888940|B2|Baseline|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
562990|NCT00888940|B1|Baseline|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
562991|NCT00888940|P2|Participant Flow|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
562992|NCT00888940|P1|Participant Flow|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
562993|NCT00888940|O2|Outcome|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
562994|NCT00888940|O1|Outcome|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
562995|NCT00888940|O2|Outcome|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
562996|NCT00888940|O1|Outcome|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
562997|NCT00888940|E2|Reported Event|Cyklokapron|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
562998|NCT00888940|E1|Reported Event|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
562999|NCT00888979|B1|Baseline|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
563000|NCT00888979|P1|Participant Flow|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
563001|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
563002|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
563003|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
563004|NCT00888979|E1|Reported Event|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
563005|NCT00889187|B1|Baseline|All Phase I: Photon Rad+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
All Phase I participants received the radiation regimen according to the established dose escalation schedule.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563006|NCT00889187|P4|Participant Flow|Phase II: Photon Rad (MTD)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
Phase II participants received the radiation regimen established in the Phase I study (MTD).
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563007|NCT00889187|P3|Participant Flow|Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563008|NCT00889187|P2|Participant Flow|Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563009|NCT00889187|P1|Participant Flow|Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563010|NCT00889187|O1|Outcome|Experimental: Phase II: Photon Rad (MTD)+Capecitabine|"Phase II participants received the radiation regimen established in the Phase I study (MTD).
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563011|NCT00889187|O3|Outcome|Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563012|NCT00889187|O2|Outcome|Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563013|NCT00889187|O1|Outcome|Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563014|NCT00889187|O1|Outcome|All Phase I: Photon Rad+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
All Phase I participants received the radiation regimen according to the established dose escalation schedule.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563063|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
572628|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
563015|NCT00889187|E3|Reported Event|Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563016|NCT00889187|E2|Reported Event|Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563017|NCT00889187|E1|Reported Event|Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:
At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.
Chemotherapy:
Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.
Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
563018|NCT00889200|B1|Baseline|Open-label Eszopiclone|"Standard dosing of drug for 6 weeks for insomnia
eszopiclone : 6 weeks standard oral therapy"
563019|NCT00889200|P1|Participant Flow|Open-label Eszopiclone|"Standard daily dosing of 3 mg drug nightly for 6 weeks for insomnia
eszopiclone : 6 weeks standard oral therapy"
563020|NCT00889200|O1|Outcome|Open-label Eszopiclone|After Standard dosing of drug for 6 weeks for insomnia, Dex/CRH test was repeated to measure cortisol reactivity with the same neuroendocrine test
563021|NCT00889200|E1|Reported Event|Open-label Eszopiclone|"Standard dosing of drug for 6 weeks for insomnia
eszopiclone : 6 weeks standard oral therapy"
563022|NCT00889252|B3|Baseline|Total|Total of all reporting groups
563023|NCT00889252|B2|Baseline|Placebo Lens|contact lens without drug
563024|NCT00889252|B1|Baseline|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563025|NCT00889252|P2|Participant Flow|Placebo Lens|contact lens without drug
563026|NCT00889252|P1|Participant Flow|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563027|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563028|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563029|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563030|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563031|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563032|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563033|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563034|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563035|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563036|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563037|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563038|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563039|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563040|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563041|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563042|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563043|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563044|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563045|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563046|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563047|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563048|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563049|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563050|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563051|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563052|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563053|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563054|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563055|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563056|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563057|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563058|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563059|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
563060|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563064|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563065|NCT00889252|E2|Reported Event|Placebo Lens|contact lens without drug
563066|NCT00889252|E1|Reported Event|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
563067|NCT00889265|B1|Baseline|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.
CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
563068|NCT00889265|P1|Participant Flow|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.
CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
563069|NCT00889265|O1|Outcome|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.
CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
563070|NCT00889265|O1|Outcome|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.
CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
563071|NCT00889265|E1|Reported Event|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.
CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
563072|NCT00889330|B3|Baseline|Total|Total of all reporting groups
563073|NCT00889330|B2|Baseline|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563074|NCT00889330|B1|Baseline|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563075|NCT00889330|P2|Participant Flow|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563076|NCT00889330|P1|Participant Flow|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563077|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563078|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563079|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563080|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563081|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563082|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563083|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563084|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563085|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563086|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563087|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563088|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563089|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563090|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563091|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563092|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563093|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563094|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563095|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563096|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563299|NCT00890682|P1|Participant Flow|SKY0402|Injection of 8cc SKY0402 (single dose)
563097|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563098|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563099|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563100|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563101|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563102|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563103|NCT00889330|E2|Reported Event|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563104|NCT00889330|E1|Reported Event|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
563105|NCT00889421|B1|Baseline|Treatment|Patient receiving apremilast.
563106|NCT00889421|P1|Participant Flow|Treatment|Patient receiving apremilast.
563107|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
563108|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
563109|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
563110|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
563111|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
563112|NCT00889421|E1|Reported Event|Treatment|Patient receiving apremilast.
563113|NCT00889512|B3|Baseline|Total|Total of all reporting groups
563114|NCT00889512|B2|Baseline|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.
Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
563115|NCT00889512|B1|Baseline|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.
Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
563116|NCT00889512|P2|Participant Flow|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.
Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
563117|NCT00889512|P1|Participant Flow|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.
Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
563118|NCT00889512|O2|Outcome|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.
Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
563119|NCT00889512|O1|Outcome|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.
Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
563120|NCT00889512|E2|Reported Event|Group B|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.
Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
563121|NCT00889512|E1|Reported Event|Group A|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.
Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
563122|NCT00889603|B1|Baseline|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563123|NCT00889603|P1|Participant Flow|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563124|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563125|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563126|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563127|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563128|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563129|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563130|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563131|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563132|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563133|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563134|NCT00889603|E1|Reported Event|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
563135|NCT00889681|B1|Baseline|Enrolled for Cryoablation Treatment|All patients that signed the informed consent were considered enrolled. Patients enrolled in the study to receive cryoablation treatment for paroxysmal atrial fibrillation.
563136|NCT00889681|P1|Participant Flow|Enrolled for Cryoablation Treatment|All patients that signed the informed consent were considered enrolled. Patients enrolled in the study received cryoablation treatment for paroxysmal atrial fibrillation.
563137|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
563138|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
563139|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
563140|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
563141|NCT00889681|E1|Reported Event|Treated With Cryoablation|"This study is a single arm, non-randomized controlled study of patients with PAF referred for ablation after failing one or more antiarrhythmic drugs used in the treatment of AF (Atrial Fibrillation Drugs  or AFDs). All study subjects will be receiving cryoablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.
Arctic Front Cardiac Cryoablation System : The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation."
563142|NCT00889707|B3|Baseline|Total|Total of all reporting groups
563143|NCT00889707|B2|Baseline|Placebo|2% HSA without PRX302
563144|NCT00889707|B1|Baseline|PRX302|0.6 microgram/gram prostate in 2% HSA
563145|NCT00889707|P2|Participant Flow|Placebo|2% (weight/volume) human serum albumin (HSA) without PRX302
563146|NCT00889707|P1|Participant Flow|PRX302|0.6 microgram/gram prostate weight in 2% (weight/volume) human serum albumin (HSA)
563147|NCT00889707|O2|Outcome|Placebo|2% HSA without PRX302
563148|NCT00889707|O1|Outcome|PRX302|0.6 microgram/gram prostate in 2% HSA
563149|NCT00889707|O2|Outcome|Placebo|2% HSA without PRX302
563150|NCT00889707|O1|Outcome|PRX302|0.6 microgram/gram prostate in 2% HSA
563151|NCT00889707|E2|Reported Event|Placebo|2% HSA without PRX302
563152|NCT00889707|E1|Reported Event|PRX302|0.6 microgram/gram prostate in 2% HSA
563153|NCT00889720|B1|Baseline|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563154|NCT00889720|P1|Participant Flow|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563155|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563156|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563157|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563158|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563159|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563160|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563161|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563162|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563163|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563164|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563165|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563166|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563167|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563168|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563300|NCT00890682|O2|Outcome|Placebo|Single injection of study drug
563169|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563170|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563171|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563172|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563173|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563174|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563175|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563176|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563177|NCT00889720|E1|Reported Event|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
563178|NCT00889824|B1|Baseline|Balcap Group|Each participant received Balcap Tactile prosthesis
563179|NCT00889824|P1|Participant Flow|Balcap Group|"Balcap group
Balcap group; balance prosthesis : vibrotactile stimulation
Patients wore a Balcap device that provided a vibrotactile stimulation that felt like a buzz either in front, back, or either side of their head when they swayed a certain distance from their center.
They wore the device daily and performed specific personalized exercises as prescribed by a physical therapist. They were tested with and without the balcap during tests of balance and postural stability when they first received the balcap and again six weeks later.
Each patient wore the balcap device a total of six weeks and then returned the device."
563180|NCT00889824|O1|Outcome|Balcap Group|Vibrotactile stimulation exercises with the device over a span of 6 weeks
563181|NCT00889824|E1|Reported Event|Balcap Group|Each participant received Balcap Tactile prosthesis
563182|NCT00889863|B1|Baseline|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563183|NCT00889863|P2|Participant Flow|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563184|NCT00889863|P1|Participant Flow|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563185|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563186|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563187|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563188|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563189|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563190|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563191|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563192|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563193|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563194|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563195|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563196|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563197|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563212|NCT00889915|P2|Participant Flow|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.
Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
563254|NCT00890097|O1|Outcome|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
563198|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563199|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563200|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563201|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563202|NCT00889863|E3|Reported Event|Placebo: Part II|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563203|NCT00889863|E2|Reported Event|Canakinumab: Part II|Participants received 4 mg/kg canakinumab subcutaneous injection in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
563204|NCT00889863|E1|Reported Event|Canakinumab: Part I|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period.
563205|NCT00889915|B5|Baseline|Total|Total of all reporting groups
563206|NCT00889915|B4|Baseline|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.
Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:
The dose form for is 5, 10, 15, 20, 25, 30 mg capsules. The typical starting dose for children greater than or equal to 6 years of age is 10 mg every day.
The FDA maximum dose per day is 30 mg if weight is greater than 50 kilograms. The off label maximum dose per day is 60 mg. The capsule may be opened and sprinkled on soft foods."
563207|NCT00889915|B3|Baseline|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).
Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:
Dose form is 18, 27, 36, 54 mg capsules. The typical starting dose is 18 mg every morning. The FDA maximum dose per day is 54 mg in children or 72 mg in adolescents. The off label maximum dose is 108 mg. Longer acting stimulants offer greater convenience, confidentiality, and compliance with single daily dosing, but may have greater problematic effects on evening appetite and sleep. Its nonabsorbable tablet shell may appear in the stool.
Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
563208|NCT00889915|B2|Baseline|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.
Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:
Dose form is 20, 30, 40, 50, 60, 70 mg ivory body/ivory cap. The typical starting dose is 30 mg every day in the morning; dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals.
The FDA maximum dose per day is 70 mg. Afternoon doses should be avoided because of the potential for insomnia. Vyvanse may be taken with or without food. Vyvanse capsules may be taken whole, or the capsule may be opened and the entire contents dissolved in a glass of water. The solution should be consumed immediately and should not be stored. The dose of a single capsule should not be divided."
563209|NCT00889915|B1|Baseline|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system. Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:
Dose form as 10, 15, 20, 30 mg patches. Typical starting dose is 10 mg patch every day then titrate up by patch strength.
The FDA maximum dose per day is 30 mg and the off label maximum dose per day is 40 mg.
The patch should be applied to the hip area, avoiding the waistline and the patch application should be alternated between hips."
563210|NCT00889915|P4|Participant Flow|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.
Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
563211|NCT00889915|P3|Participant Flow|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).
Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
563213|NCT00889915|P1|Participant Flow|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.
Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
563214|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.
Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
563215|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).
Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
563216|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.
Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
563217|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.
Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
563218|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.
Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
563219|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).
Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
563220|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.
Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
563221|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.
Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
563222|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.
Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
563223|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).
Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
563224|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.
Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
563225|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.
Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
563226|NCT00889915|E4|Reported Event|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.
Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
563227|NCT00889915|E3|Reported Event|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).
Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
563228|NCT00889915|E2|Reported Event|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.
Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
563229|NCT00889915|E1|Reported Event|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.
Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
563230|NCT00889928|B1|Baseline|Cholecystectomy|transvaginal cholecystectomy
563231|NCT00889928|P1|Participant Flow|Cholecystectomy|transvaginal cholecystectomy
563232|NCT00889928|O1|Outcome|Transvaginal Cholecystectomy|
563233|NCT00889928|E1|Reported Event|Cholecystectomy|transvaginal cholecystectomy
563234|NCT00890084|B1|Baseline|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
563235|NCT00890084|P1|Participant Flow|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
563236|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
563237|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
563238|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
563239|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
563240|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
563241|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
563242|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
563243|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
563244|NCT00890084|E1|Reported Event|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
563245|NCT00890097|B4|Baseline|Total|Total of all reporting groups
563246|NCT00890097|B3|Baseline|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
563247|NCT00890097|B2|Baseline|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
563248|NCT00890097|B1|Baseline|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
563249|NCT00890097|P3|Participant Flow|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
563250|NCT00890097|P2|Participant Flow|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
563251|NCT00890097|P1|Participant Flow|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
563252|NCT00890097|O3|Outcome|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
563253|NCT00890097|O2|Outcome|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
563255|NCT00890097|E3|Reported Event|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
563256|NCT00890097|E2|Reported Event|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
563257|NCT00890097|E1|Reported Event|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
563258|NCT00890201|B3|Baseline|Total|Total of all reporting groups
563259|NCT00890201|B2|Baseline|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
563260|NCT00890201|B1|Baseline|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
563261|NCT00890201|P2|Participant Flow|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
563262|NCT00890201|P1|Participant Flow|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
563263|NCT00890201|O2|Outcome|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
563264|NCT00890201|O1|Outcome|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
563265|NCT00890201|E2|Reported Event|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
563266|NCT00890201|E1|Reported Event|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
563267|NCT00890409|B3|Baseline|Total|Total of all reporting groups
563268|NCT00890409|B2|Baseline|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
563269|NCT00890409|B1|Baseline|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
563270|NCT00890409|P2|Participant Flow|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
563271|NCT00890409|P1|Participant Flow|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
563272|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
563273|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
563274|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
563275|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
563276|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
563277|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
563278|NCT00890552|B1|Baseline|Lenalidomide, Melphalan and Dexamethasone (MDR)|The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
563294|NCT00890656|E1|Reported Event|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
563295|NCT00890682|B3|Baseline|Total|Total of all reporting groups
563296|NCT00890682|B2|Baseline|Placebo|Study Drug Injection
563297|NCT00890682|B1|Baseline|Sky0402|Injection of Study Drug
563298|NCT00890682|P2|Participant Flow|Placebo|Injection of 8cc Placebo (single dose)
563279|NCT00890552|P1|Participant Flow|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.
Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.
Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
563280|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.
Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.
Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
563281|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.
Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.
Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
563282|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.
Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.
Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
563283|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.
Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.
Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
563284|NCT00890552|E1|Reported Event|Lenalidomide, Melphalan and Dexamethasone (MDR)|The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
563285|NCT00890591|B1|Baseline|Olmesartan + Hydrochlorothiazide + Amlodipine|"olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.
olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved
olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved
olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved"
563286|NCT00890591|P1|Participant Flow|Olmesartan + Hydrochlorothiazide + Amlodipine|"olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.
olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved
olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved
olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved"
563287|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide + Amlodipine|olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets + amlodipine tablets 5 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
563288|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide|olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
563289|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide|olmesartan 20 mg/hydrochlorothiazide 12.5 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
563290|NCT00890591|O1|Outcome|Olmesartan Monotherapy|olmesartan monotherapy 20 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
563291|NCT00890656|B1|Baseline|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
563292|NCT00890656|P1|Participant Flow|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
563293|NCT00890656|O1|Outcome|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
563306|NCT00890695|B1|Baseline|1 RUSF|RUSF prescribed for the child for 4 weeks
563307|NCT00890695|P2|Participant Flow|2 Normal Diet|For equity, parents or guardians of children in the usual diet arm are given 2 bags of maize meal (4Kg) for family consumption instead of RUSF. All parents and carers in both arms will also receive standard nutritional advice as specified in the current WHO IMCI handbook.
563308|NCT00890695|P1|Participant Flow|1 Ready to Use Supplementary Food (RUSF)|"Products, Kenya. The RUSF composition is in accordance with recommended supplementary feed composition specified by the latest WHO expert consultation in 2008 reported by Golden et al. It is formulated to provide 507 kcal per 100g, 6% protein/energy ratio and 55% fat/energy ratio. Essential fatty acids contained are N-6 (linoleic acid) 6 kcal % and N-3 (o-linoleic) 0.3 kcal %. Vitamin and mineral premix (3%) will provide the currently recommended nutrient intake for moderately malnourished children of minerals (K, Na, Ca, P, Mg, Fe, Zn, Cu, Se, I, Mn, Cr, Mo, F), Vitamins (thiamine, riboflavin, pyridoxine, niacin, Vit B12, folic acid, Vit C, Biotin, Pantothenic acid, Vit A, Vit D,Vit E and Vit K).
initial visit. The amount supplied is based on the child's weight; the recommended energy supplement being 100kcal per kg per day which is equivalent to 25g RUSF per kg per day."
563309|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
563310|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
563311|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
563312|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
563313|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
563314|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
563315|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
563316|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
563317|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
563318|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
563319|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
563320|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
563321|NCT00890695|E2|Reported Event|2 Normal Diet|normal diet arm
563322|NCT00890695|E1|Reported Event|1 RUSF|RUSF prescribed for the child for 4 weeks
563323|NCT00890721|B3|Baseline|Total|Total of all reporting groups
563324|NCT00890721|B2|Baseline|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
563325|NCT00890721|B1|Baseline|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
563326|NCT00890721|P2|Participant Flow|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
563327|NCT00890721|P1|Participant Flow|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
563328|NCT00890721|O2|Outcome|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
563329|NCT00890721|O1|Outcome|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
563330|NCT00890721|E2|Reported Event|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
563331|NCT00890721|E1|Reported Event|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
563332|NCT00890916|B1|Baseline|Neuroprosthesis System|"Receives implanted device for hand function.
FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels. Also known as the IST-12 System."
563333|NCT00890916|P1|Participant Flow|Neuroprosthesis System|Subjects who have undergone implantation of the neuroprosthesis system known as the FIRSTHAND/IST-12 System.
563334|NCT00890916|O1|Outcome|Neuroprosthesis System|Subjects with the implanted FIRSTHAND/IST-12 System.
563335|NCT00890916|E1|Reported Event|Neuroprosthesis System|"Receives implanted device for hand function.
FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels."
563336|NCT00890929|B1|Baseline|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563337|NCT00890929|P1|Participant Flow|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563338|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563339|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563340|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563341|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563342|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563343|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563378|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563344|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563345|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563346|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563347|NCT00890929|E1|Reported Event|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion
Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
563348|NCT00890981|B3|Baseline|Total|Total of all reporting groups
563349|NCT00890981|B2|Baseline|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563350|NCT00890981|B1|Baseline|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563351|NCT00890981|P2|Participant Flow|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563352|NCT00890981|P1|Participant Flow|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179 (NCT00293813). No study drug was administered during this study.
563353|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563354|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563355|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563356|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563357|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563358|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563359|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563360|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563361|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563362|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563363|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563364|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563365|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563366|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563367|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563368|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563369|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563370|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563371|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563372|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563373|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563374|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563375|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563376|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563377|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563379|NCT00890981|E2|Reported Event|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
563380|NCT00890981|E1|Reported Event|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
563381|NCT00891020|B4|Baseline|Total|Total of all reporting groups
563382|NCT00891020|B3|Baseline|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563383|NCT00891020|B2|Baseline|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563384|NCT00891020|B1|Baseline|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563385|NCT00891020|P3|Participant Flow|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563386|NCT00891020|P2|Participant Flow|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563387|NCT00891020|P1|Participant Flow|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563388|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563389|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563390|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563391|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563392|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563393|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563394|NCT00891020|O1|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563427|NCT00891046|B4|Baseline|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563772|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563395|NCT00891020|O1|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563396|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563397|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563398|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563399|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563400|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563401|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563402|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563403|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563404|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563405|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563406|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563407|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563408|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563428|NCT00891046|B3|Baseline|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563773|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563774|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563409|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563410|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563411|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563412|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563413|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563414|NCT00891020|E3|Reported Event|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563415|NCT00891020|E2|Reported Event|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563416|NCT00891020|E1|Reported Event|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
563417|NCT00885482|B1|Baseline|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
563418|NCT00885482|P1|Participant Flow|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
563419|NCT00885482|O1|Outcome|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
563420|NCT00885482|E1|Reported Event|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
563421|NCT00885534|B1|Baseline|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:
Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
563422|NCT00885534|P1|Participant Flow|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:
Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
563423|NCT00885534|O1|Outcome|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:
Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
563424|NCT00885534|E1|Reported Event|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:
Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
563425|NCT00891046|B6|Baseline|Total|Total of all reporting groups
563426|NCT00891046|B5|Baseline|ACZ885 Treatment Naive|Participants who were canakinumab treatment­ naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
572629|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
563429|NCT00891046|B2|Baseline|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563430|NCT00891046|B1|Baseline|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563431|NCT00891046|P5|Participant Flow|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563432|NCT00891046|P4|Participant Flow|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563433|NCT00891046|P3|Participant Flow|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in CACZ885G2301 (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563434|NCT00891046|P2|Participant Flow|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed Study CACZ885G2301 (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563435|NCT00891046|P1|Participant Flow|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from Study CACZ885G2301 Part 2 (NCT00889863) due to SJIA flare, received a subcutaneous (s.c.).
563436|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
563437|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563438|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
563439|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563440|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563441|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563442|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in CACZ885G2301 Study ­Part I (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563443|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study CACZ885G2301 ­ Part II (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563444|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from CACZ885G2301 study Part II (NCT00889863), received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563445|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
563446|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563447|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563448|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563449|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563450|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563451|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563775|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563452|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563453|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563454|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563455|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563456|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563457|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563458|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563459|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563460|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563461|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563462|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563463|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563464|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563465|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563466|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
563467|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563468|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563469|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563470|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563471|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563472|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563473|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563776|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563777|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563474|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563475|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563476|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563477|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563478|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563479|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563480|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563481|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563482|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563483|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563484|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in CACZ885G2301 Study ­Part I (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563485|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study CACZ885G2301 ­ Part II (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563486|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from CACZ885G2301 study Part II (NCT00889863), received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563487|NCT00891046|O4|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to other biologics, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563488|NCT00891046|O3|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued other biologics for other reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563489|NCT00891046|O2|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued other biologics for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563490|NCT00891046|O1|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment­ naive and who discontinued other biologics due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563491|NCT00891046|O4|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to tocilizumab, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563492|NCT00891046|O3|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued tocilizumab for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563493|NCT00891046|O2|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued tocilizumab for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563494|NCT00891046|O1|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment naive and who discontinued tocilizumab due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563495|NCT00891046|O4|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to anakinra, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563496|NCT00891046|O3|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued anakinra for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563497|NCT00891046|O2|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued anakinra for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563498|NCT00891046|O1|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment naive and who discontinued anakinra due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563499|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
563500|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563501|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
563502|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563503|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
563504|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563505|NCT00891046|E2|Reported Event|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
563506|NCT00891046|E1|Reported Event|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
563507|NCT00891176|B5|Baseline|Total|Total of all reporting groups
563508|NCT00891176|B4|Baseline|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563509|NCT00891176|B3|Baseline|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563510|NCT00891176|B2|Baseline|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563511|NCT00891176|B1|Baseline|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563512|NCT00891176|P4|Participant Flow|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563513|NCT00891176|P3|Participant Flow|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563778|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563779|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563514|NCT00891176|P2|Participant Flow|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563515|NCT00891176|P1|Participant Flow|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563516|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563517|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563518|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563519|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563520|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563521|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563522|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563523|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563696|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
563780|NCT00891982|E2|Reported Event|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563781|NCT00891982|E1|Reported Event|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563524|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563525|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563526|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563527|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563528|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563529|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563530|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563531|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563532|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563533|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563534|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563782|NCT00891995|B3|Baseline|Total|Total of all reporting groups
563535|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563536|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563537|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563538|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563539|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563540|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563541|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563542|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563543|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563544|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563545|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563967|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
563546|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563547|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563548|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563549|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563550|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563551|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563552|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563553|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563554|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563555|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563556|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563557|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563558|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563559|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563560|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563561|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563562|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563563|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563564|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563565|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563566|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563567|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563568|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563569|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563570|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563571|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563572|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563573|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563574|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563575|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563576|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563577|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563578|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
564332|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
563579|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563580|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563581|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563582|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563583|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563584|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563585|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563586|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563587|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563588|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563589|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
564333|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
563590|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563591|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563592|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563593|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563594|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563595|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563596|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563597|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563598|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563599|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563600|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563601|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563602|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563603|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563604|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563605|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563606|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563607|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563608|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563609|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563610|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563611|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563612|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563613|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563614|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563615|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563616|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563617|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563618|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563619|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563620|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563621|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563622|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
564334|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
563623|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563624|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563625|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563626|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563627|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563628|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563629|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563630|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563631|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563632|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563633|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
564335|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
563634|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563635|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563636|NCT00891176|E4|Reported Event|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563637|NCT00891176|E3|Reported Event|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
563638|NCT00891176|E2|Reported Event|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563639|NCT00891176|E1|Reported Event|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
563640|NCT00891202|B3|Baseline|Total|Total of all reporting groups
563641|NCT00891202|B2|Baseline|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
563642|NCT00891202|B1|Baseline|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
563643|NCT00891202|P4|Participant Flow|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563644|NCT00891202|P3|Participant Flow|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563645|NCT00891202|P2|Participant Flow|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
563646|NCT00891202|P1|Participant Flow|PAP: Eliglustat|Eliglustat tartrate capsule as a single 50 milligram (mg) dose on Day 1 followed by eliglustat tartrate 50 mg capsule twice daily (BID) from Day 2 to Week 4, and then either eliglustat tartrate 50 mg capsule BID (in participants who had a Genz-99067 [active moiety of eliglustat tartrate in plasma] trough plasma concentration greater than or equal to [>=] 5 nanogram per milliliter [ng/mL]) or eliglustat tartrate 100 mg capsule BID (in participants who had a Genz-99067 trough plasma concentration less than [<] 5 ng/mL), up to Week 39. The pharmacokinetic (PK) assessment at Week 2 was used for dose adjustment after Week 4.
563697|NCT00891813|E1|Reported Event|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
563783|NCT00891995|B2|Baseline|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563647|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563648|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563649|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563650|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563651|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563652|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563653|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563654|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563655|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
563656|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
563657|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
563658|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
563659|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
563660|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
563661|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
563662|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
563663|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
563664|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
563770|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563665|NCT00891202|E2|Reported Event|Placebo|PAP: Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39. LTTP: Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline for LTTP. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563666|NCT00891202|E1|Reported Event|Eliglustat|PAP: Eliglustat tartrate capsule 50 mg orally on Day 1 followed by eliglustat tartrate 50 mg capsule BID from Day 2 to Week 4, then either eliglustat tartrate 50 mg capsule BID(participants with Genz-99067 trough plasma concentration>=5 ng/mL) or eliglustat tartrate 100 mg capsule BID(participants with Genz-99067 trough plasma concentration<5 ng/mL), up to Week 39. PK assessment at Week 2 used for dose adjustment after Week 4. LTTP: Participants of the eliglustat arm in PAP who completed PAP were included in LTTP & received eliglustat tartrate capsule 50 mg BID orally from Day 1(post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 & Week 47 were based on Genz-99067 trough plasma concentrations(if trough plasma concentration<5 ng/mL: next higher dose administered;if>=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
563667|NCT00891293|B1|Baseline|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563668|NCT00891293|P1|Participant Flow|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563669|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563670|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563671|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563672|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563673|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563674|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563675|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563676|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563677|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563678|NCT00891293|E1|Reported Event|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
563679|NCT00891371|B1|Baseline|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
563680|NCT00891371|P1|Participant Flow|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
563681|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
563682|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
563683|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
563684|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
563685|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
563686|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
563687|NCT00891371|E1|Reported Event|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
563688|NCT00891774|B1|Baseline|Device|Treatment with EVOLENCE®
563689|NCT00891774|P1|Participant Flow|Device|Treatment with EVOLENCE®
563690|NCT00891774|O1|Outcome|Device|Treatment with EVOLENCE®
563691|NCT00891774|E1|Reported Event|Device|Treatment with EVOLENCE®
563692|NCT00891813|B1|Baseline|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
563693|NCT00891813|P1|Participant Flow|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
563694|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
563695|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
563771|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563698|NCT00891839|B1|Baseline|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
563699|NCT00891839|P1|Participant Flow|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
563700|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
563701|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
563702|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
563703|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
563704|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
563705|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
563706|NCT00891839|E1|Reported Event|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
563707|NCT00891904|B1|Baseline|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
563708|NCT00891904|P1|Participant Flow|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
563709|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
563710|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
563711|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
563712|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
563713|NCT00891904|E1|Reported Event|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
563714|NCT00891930|B1|Baseline|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
563715|NCT00891930|P1|Participant Flow|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
563716|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
563717|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
563718|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
563719|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
563720|NCT00891930|O1|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
572630|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
563721|NCT00891930|O1|Outcome|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
563722|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
563723|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
563724|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
563725|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
563726|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
563727|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
563728|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
563729|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
563730|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
563731|NCT00891930|O1|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
563732|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
563733|NCT00891930|E2|Reported Event|Part-2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
563734|NCT00891930|E1|Reported Event|Part-1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
563735|NCT00891982|B3|Baseline|Total|Total of all reporting groups
563736|NCT00891982|B2|Baseline|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563737|NCT00891982|B1|Baseline|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563738|NCT00891982|P2|Participant Flow|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563739|NCT00891982|P1|Participant Flow|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563740|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563741|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563742|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563743|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563744|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563745|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563746|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563747|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563748|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563749|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563750|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563751|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563752|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563753|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563754|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563755|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563756|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563757|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563758|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563759|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563760|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563761|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563762|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563763|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563764|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563765|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563766|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563767|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563768|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
563769|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
563784|NCT00891995|B1|Baseline|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
563785|NCT00891995|P2|Participant Flow|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563786|NCT00891995|P1|Participant Flow|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and continuous glucose monitoring (CGM) in addition to standard monitoring with a home glucose meter for 2 years.
563787|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563788|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
563789|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563790|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
563791|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563792|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
563793|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563794|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
563795|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563796|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
563797|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563798|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
563799|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563800|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
563801|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563802|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
563803|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563804|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
563805|NCT00891995|E2|Reported Event|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
563806|NCT00891995|E1|Reported Event|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
563807|NCT00892008|B1|Baseline|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563808|NCT00892008|P1|Participant Flow|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563809|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563810|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563811|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563812|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563813|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563814|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563815|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563816|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563817|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563818|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563819|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563820|NCT00892008|E1|Reported Event|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
563821|NCT00892047|B3|Baseline|Total|Total of all reporting groups
563822|NCT00892047|B2|Baseline|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks."
563823|NCT00892047|B1|Baseline|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks."
563824|NCT00892047|P2|Participant Flow|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
563825|NCT00892047|P1|Participant Flow|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
563826|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
563827|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
563828|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
563829|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
563830|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
563831|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
563832|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
563833|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
563834|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
563835|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
563836|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks."
563837|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks."
563838|NCT00892047|E2|Reported Event|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
563839|NCT00892047|E1|Reported Event|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo
venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
563840|NCT00892099|B4|Baseline|Total|Total of all reporting groups
563841|NCT00892099|B3|Baseline|Placebo|"Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
563842|NCT00892099|B2|Baseline|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly"
563843|NCT00892099|B1|Baseline|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly"
563844|NCT00892099|P3|Participant Flow|Placebo|"Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
563845|NCT00892099|P2|Participant Flow|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly"
563846|NCT00892099|P1|Participant Flow|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly"
563847|NCT00892099|O3|Outcome|Placebo|"Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
563848|NCT00892099|O2|Outcome|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly"
563849|NCT00892099|O1|Outcome|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly"
563850|NCT00892099|E3|Reported Event|Placebo|"Receives no ergocalciferol
Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
563851|NCT00892099|E2|Reported Event|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month
Ergocalciferol: 50,000 IU tablet given monthly"
563852|NCT00892099|E1|Reported Event|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly
Ergocalciferol: 50,000 IU tablet given weekly"
563853|NCT00892151|B1|Baseline|Intended Users of the Software|Baseline measures apply to lay persons (n=40) not healthcare professionals in the study.
563854|NCT00892151|P1|Participant Flow|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
563855|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
563856|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
563857|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
563858|NCT00892151|E1|Reported Event|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
563859|NCT00892177|B4|Baseline|Total|Total of all reporting groups
563860|NCT00892177|B3|Baseline|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563861|NCT00892177|B2|Baseline|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563862|NCT00892177|B1|Baseline|Phase I|Patients receive (either: 5 or 10 mg/kg) bevacizumab IV over 90 minutes on Day 1 and oral dasatinib (either: 50, 70, or 100 mg) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563863|NCT00892177|P6|Participant Flow|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563864|NCT00892177|P5|Participant Flow|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563865|NCT00892177|P4|Participant Flow|Phase I: Dose Level 3|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563866|NCT00892177|P3|Participant Flow|Phase I: Dose Level 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563867|NCT00892177|P2|Participant Flow|Phase I: Dose Level 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563868|NCT00892177|P1|Participant Flow|Phase I: Dose Level 0|Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563869|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563870|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563871|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563872|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563873|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563874|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
564033|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
563875|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563876|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563877|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563878|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563879|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563880|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563881|NCT00892177|O5|Outcome|Phase I: Dose Level 3 Cohort 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563882|NCT00892177|O4|Outcome|Phase I : Dose Level 3 Cohort 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563883|NCT00892177|O3|Outcome|Phase I : Dose Level 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 70 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563884|NCT00892177|O2|Outcome|Phase I : Dose Level 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563885|NCT00892177|O1|Outcome|Phase I : Dose Level 0|Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563886|NCT00892177|E6|Reported Event|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563887|NCT00892177|E5|Reported Event|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563888|NCT00892177|E4|Reported Event|Phase I: Dose Level 3|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563889|NCT00892177|E3|Reported Event|Phase I: Dose Level 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563890|NCT00892177|E2|Reported Event|Phase I: Dose Level 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563891|NCT00892177|E1|Reported Event|Phase I: Dose Level 0|Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
563892|NCT00892281|B3|Baseline|Total|Total of all reporting groups
563893|NCT00892281|B2|Baseline|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
563894|NCT00892281|B1|Baseline|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
563895|NCT00892281|P2|Participant Flow|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
563896|NCT00892281|P1|Participant Flow|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
563897|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
563898|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
563899|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
563900|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
563930|NCT00892606|O2|Outcome|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation
Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
563901|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
563902|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
563903|NCT00892281|E2|Reported Event|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
563904|NCT00892281|E1|Reported Event|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
563905|NCT00892437|B3|Baseline|Total|Total of all reporting groups
563906|NCT00892437|B2|Baseline|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563907|NCT00892437|B1|Baseline|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563908|NCT00892437|P2|Participant Flow|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563909|NCT00892437|P1|Participant Flow|ATV+COBI+FTC/TDF|"Randomized Phase: Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563910|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563911|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563912|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563913|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563914|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563915|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563916|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563917|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563918|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563919|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563920|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563921|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
563922|NCT00892437|E3|Reported Event|All ATV+COBI+FTC/TDF|The All ATV+COBI+FTC/TDF Safety Analysis Set included all participants who received at least 1 dose of COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind ATV+COBI+FTC/TDF group while they received double-blind ATV+COBI+FTC/TDF during the randomized phase and open-label ATV+COBI+FTC/TDF during the extension phase; adverse events collected from the open-label ATV+COBI+FTC/TDF extension phase only from the participants who were initially randomized to the ATV+RTV+FTC/TDF group during the randomized phase. Adverse event data collected up to Week 286 are presented in this entry.
563923|NCT00892437|E2|Reported Event|ATV+RTV+FTC/TDF|For the reporting of Adverse Events, this group includes participants who were randomized to receive RTV 100 mg+COBI placebo+ATV 300 mg+FTC 200 mg/TDF 300 mg once daily in the randomized period, and were analyzed from Baseline to Week 60.
563924|NCT00892437|E1|Reported Event|ATV+COBI+FTC/TDF|For the reporting of Adverse Events, this group includes participants who were randomized to receive COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily in the randomized phase, and were analyzed from Baseline to Week 60.
563925|NCT00892606|B3|Baseline|Total|Total of all reporting groups
563926|NCT00892606|B2|Baseline|Control|Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg morphine
563927|NCT00892606|B1|Baseline|Methadone|Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg of methadone IV immediately after intubation
563928|NCT00892606|P2|Participant Flow|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation
Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
563929|NCT00892606|P1|Participant Flow|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation
Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
563931|NCT00892606|O1|Outcome|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation
Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
563932|NCT00892606|O2|Outcome|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation
Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
563933|NCT00892606|O1|Outcome|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation
Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
563934|NCT00892606|O2|Outcome|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation
Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
563935|NCT00892606|O1|Outcome|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation
Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
563936|NCT00892606|E2|Reported Event|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation
Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
563937|NCT00892606|E1|Reported Event|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation
Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
563938|NCT00892697|B1|Baseline|Telaprevir/Peg-IFN/RBV|"15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.
Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg)."
563939|NCT00892697|P1|Participant Flow|Telaprevir/Peg-IFN/RBV|"15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.
Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg)."
563940|NCT00892697|O1|Outcome|Telaprevir/PEG-IFN/RBV|15 subjects will receive Telaprevir in combination with pegylated interferon alfa-2a and ribavirin
563941|NCT00892697|O1|Outcome|Telaprevir/Peg-IFN/RBV|"15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.
Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy."
563942|NCT00892697|E1|Reported Event|Telaprevir/PEG-IFN/RBV|"15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.
Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy."
563943|NCT00892710|B4|Baseline|Total|Total of all reporting groups
563944|NCT00892710|B3|Baseline|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days"
563945|NCT00892710|B2|Baseline|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days"
563946|NCT00892710|B1|Baseline|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
563947|NCT00892710|P3|Participant Flow|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days"
563948|NCT00892710|P2|Participant Flow|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days"
563949|NCT00892710|P1|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
563950|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days"
563951|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days"
563952|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
563953|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days"
563954|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days"
563955|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
563956|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days"
563957|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days"
563958|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
563959|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days"
563960|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days"
563961|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
563962|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days"
563963|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days"
563964|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
563965|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days"
563966|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days"
572631|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
563968|NCT00892710|E3|Reported Event|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days"
563969|NCT00892710|E2|Reported Event|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days"
563970|NCT00892710|E1|Reported Event|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
563971|NCT00892723|B4|Baseline|Total|Total of all reporting groups
563972|NCT00892723|B3|Baseline|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
563973|NCT00892723|B2|Baseline|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
563974|NCT00892723|B1|Baseline|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
563975|NCT00892723|P3|Participant Flow|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
563976|NCT00892723|P2|Participant Flow|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
563977|NCT00892723|P1|Participant Flow|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
563978|NCT00892723|O9|Outcome|Scar Total Volume - 1 mg AZX100|This group included Month 12 scar total volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563979|NCT00892723|O8|Outcome|Scar Total Volume - 0.3 mg AZX100|This group included Month 12 scar total volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563980|NCT00892723|O7|Outcome|Scar Total Volume - Placebo|This group included Month 12 scar total volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563981|NCT00892723|O6|Outcome|Scar Negative Volume - 1 mg AZX100|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563982|NCT00892723|O5|Outcome|Scar Negative Volume - 0.3 mg AZX100|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563983|NCT00892723|O4|Outcome|Scar Negative Volume - Placebo|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563984|NCT00892723|O3|Outcome|Scar Positive Volume - 1 mg AZX100|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563985|NCT00892723|O2|Outcome|Scar Positive Volume - 0.3 mg AZX100|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received 0.3 mg AZx100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563986|NCT00892723|O1|Outcome|Scar Positive Volume - Placebo|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563987|NCT00892723|O15|Outcome|Scar Mean Elevation - 1 mg AZX100|This group included Month 12 scar mean elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563988|NCT00892723|O14|Outcome|Scar Mean Elevation - 0.3 mg AZX100|This group included Month 12 scar mean elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563989|NCT00892723|O13|Outcome|Scar Mean Elevation - Placebo|This group included Month 12 scar mean elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563990|NCT00892723|O12|Outcome|Scar Maximum Elevation - 1 mg AZX100|This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563991|NCT00892723|O11|Outcome|Scar Maximum Elevation - 0.3 mg AZX100|This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563992|NCT00892723|O10|Outcome|Scar Maximum Elevation - Placebo|This group included Month 12 scar maximum elevation measurements f(mm) or those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563993|NCT00892723|O9|Outcome|Scar Minimum Elevation - 1 mg AZX100|This group included Month 12 scar minimum elevation measurements f(mm) or those patients who received 1 mg/ AZX100linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563994|NCT00892723|O8|Outcome|Scar Minimum Elevation - 0.3 mg AZX100|This group included Month 12 scar minimum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563995|NCT00892723|O7|Outcome|Scar Minimum Elevation - Placebo|This group included Month 12 scar minimum elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563996|NCT00892723|O6|Outcome|Scar Width - 1 mg AZX100|This group included Month 12 scar width measurements (mm)for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
564034|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
563997|NCT00892723|O5|Outcome|Scar Width - 0.3 mg AZX100|This group included Month 12 scar width measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563998|NCT00892723|O4|Outcome|Scar Width - Placebo|This group included Month 12 scar width measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
563999|NCT00892723|O3|Outcome|Scar Length - 1 mg AZX100|This group included Month 12 scar length measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
564000|NCT00892723|O2|Outcome|Scar Length - 0.3 mg AZX100|This group included Month 12 scar length measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
564001|NCT00892723|O1|Outcome|Scar Length - Placebo|This group included Month 12 scar length measurements (mm)for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
564002|NCT00892723|O6|Outcome|Rater 2 VAS Scores for 1 mg AZX100|This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
564003|NCT00892723|O5|Outcome|Rater 2 VAS Scores for 0.3 mg AZX100|This group included Month 12 VAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
564004|NCT00892723|O4|Outcome|Rater 2 VAS Scores for Placebo|This group included Month 12 VAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
564005|NCT00892723|O3|Outcome|Rater 1 VAS Scores for 1 mg AZX100|This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
564006|NCT00892723|O2|Outcome|Rater 1 VAS Scores for 0.3 mg AZX100|This group included Month 12 VAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
564007|NCT00892723|O1|Outcome|Rater 1 VAS Scores for Placebo|This group included Month 12 VAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
564008|NCT00892723|O6|Outcome|OSAS Results for 1 mg AZX100|This group included Month 12 OSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
564009|NCT00892723|O5|Outcome|OSAS Results for 0.3 mg AZX100|This group included Month 12 OSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
564010|NCT00892723|O4|Outcome|OSAS Results for Placebo|This group included Month 12 OSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
564011|NCT00892723|O3|Outcome|PSAS Results for 1 mg AZX100|This group included Month 12 PSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
564012|NCT00892723|O2|Outcome|PSAS Results for 0.3 mg AZX100|This group included Month 12 PSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
564013|NCT00892723|O1|Outcome|PSAS Results for Placebo|This group included Month 12 PSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
564014|NCT00892723|E3|Reported Event|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
564015|NCT00892723|E2|Reported Event|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
564016|NCT00892723|E1|Reported Event|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
564017|NCT00892957|B3|Baseline|Total|Total of all reporting groups
564018|NCT00892957|B2|Baseline|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
564019|NCT00892957|B1|Baseline|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
564020|NCT00892957|P2|Participant Flow|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
564021|NCT00892957|P1|Participant Flow|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
564022|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564023|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564024|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564025|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564026|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
564027|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
564028|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
564029|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
564030|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
564031|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
564032|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
572632|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
564035|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
564036|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
564037|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
564038|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
564039|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
564040|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
564041|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
564042|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
564043|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
564044|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
564045|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
564046|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
564047|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
564048|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
564049|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
564050|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
564051|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
564052|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
564053|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
564054|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
564055|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
564056|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
564057|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
564058|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
564059|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
564060|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
564061|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
564062|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
564063|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
564064|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
564065|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
564066|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
564067|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
564068|NCT00892957|O2|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
564069|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
564070|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564071|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564072|NCT00892957|O6|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
564073|NCT00892957|O5|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
564074|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
564075|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
564076|NCT00892957|O2|Outcome|Control: Preop Baseline - Intraoperative Day 0|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
564077|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr was applied to the study suture line
564078|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564079|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564080|NCT00892957|O6|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
564081|NCT00892957|O5|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
564082|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
564083|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
564084|NCT00892957|O2|Outcome|Control: Preop Baseline - Intraoperative Day 0|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
564085|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr was applied to the study suture line
564086|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564087|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564088|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564089|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564090|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564091|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564092|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564093|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564094|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564095|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564096|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564097|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564098|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564099|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564100|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564101|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564102|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
564103|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
564104|NCT00892957|E2|Reported Event|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
564105|NCT00892957|E1|Reported Event|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
564106|NCT00893074|B1|Baseline|Study Participant|Participants who received active drug as part of the study
564107|NCT00893074|P1|Participant Flow|0, 30, 60, and 120mg Dronabinol|0, 30, 60, and 120mg Dronabinol administered for 5 consecutive days in a double blind, placebo controlled study, with dose administered in a random order to the same study participants
564108|NCT00893074|O4|Outcome|120mg Dronabinol|120mg (40mg tid) dronabinol maintenance
564109|NCT00893074|O3|Outcome|60mg Dronabinol|60mg (20mg tid) dronabinol maintenance
564110|NCT00893074|O2|Outcome|30mg Dronabinol|30mg (10mg tid) dronabinol maintenance
564111|NCT00893074|O1|Outcome|Placebo|placebo dronabinol maintenance
564112|NCT00893074|O4|Outcome|120mg Dronabinol|120mg (40mg tid) dronabinol maintenance
564113|NCT00893074|O3|Outcome|60mg Dronabinol|60mg (20mg tid) dronabinol maintenance
564114|NCT00893074|O2|Outcome|30mg Dronabinol|30mg (10mg tid) dronabinol maintenance
564115|NCT00893074|O1|Outcome|Placebo|Placebo dronabinol maintenance
564116|NCT00893074|O4|Outcome|120mg Dronabinol|120mg daily dronabinol (40mg tid) administered for 5 days
564117|NCT00893074|O3|Outcome|60mg Dronabinol|60mg daily dronabinol (20mg tid) administered for 5 days
564118|NCT00893074|O2|Outcome|30mg Dronabinol|30mg daily dronabinol (10mg tid) administered for 5 days
564119|NCT00893074|O1|Outcome|Placebo|0mg daily dronabinol administered for 5 days
564120|NCT00893074|E4|Reported Event|120mg|120mg dronabinol maintenance
564121|NCT00893074|E3|Reported Event|60mg|60mg dronabinol maintenance
564122|NCT00893074|E2|Reported Event|30mg|30mg dronabinol maintenance
564123|NCT00893074|E1|Reported Event|Placebo|Placebo maintenance
564124|NCT00893113|B3|Baseline|Total|Total of all reporting groups
564125|NCT00893113|B2|Baseline|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
564126|NCT00893113|B1|Baseline|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
564127|NCT00893113|P2|Participant Flow|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
564128|NCT00893113|P1|Participant Flow|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
564129|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
564130|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
564131|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
564132|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
564133|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
564134|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
564135|NCT00893113|E2|Reported Event|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
564136|NCT00893113|E1|Reported Event|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
564137|NCT00893152|B3|Baseline|Total|Total of all reporting groups
564138|NCT00893152|B2|Baseline|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
564139|NCT00893152|B1|Baseline|Veterans|Participants in focus groups or individual qualitative interviews
564140|NCT00893152|P2|Participant Flow|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
564141|NCT00893152|P1|Participant Flow|Veterans|Participants in focus groups or individual qualitative interviews
564142|NCT00893152|O2|Outcome|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
564143|NCT00893152|O1|Outcome|Veterans|Participants in focus groups or individual qualitative interviews
564144|NCT00893152|E2|Reported Event|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
564145|NCT00893152|E1|Reported Event|Veterans|Participants in focus groups or individual qualitative interviews
564146|NCT00893464|B9|Baseline|Total|Total of all reporting groups
564147|NCT00893464|B8|Baseline|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564148|NCT00893464|B7|Baseline|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564149|NCT00893464|B6|Baseline|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564150|NCT00893464|B5|Baseline|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564151|NCT00893464|B4|Baseline|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564152|NCT00893464|B3|Baseline|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564153|NCT00893464|B2|Baseline|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564154|NCT00893464|B1|Baseline|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564155|NCT00893464|P8|Participant Flow|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564156|NCT00893464|P7|Participant Flow|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564157|NCT00893464|P6|Participant Flow|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564158|NCT00893464|P5|Participant Flow|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708) 1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564159|NCT00893464|P4|Participant Flow|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564160|NCT00893464|P3|Participant Flow|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564161|NCT00893464|P2|Participant Flow|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564162|NCT00893464|P1|Participant Flow|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity.
564163|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564164|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564165|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564166|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564167|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564168|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564169|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564170|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564171|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564172|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564173|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564174|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564175|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564176|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564177|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564178|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564179|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564180|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564181|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564182|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564183|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564184|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564185|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564186|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564187|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564188|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564189|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564190|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564191|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564192|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564193|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564194|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564195|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564196|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564197|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564198|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564199|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564200|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564201|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564202|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564203|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564204|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564205|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564206|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564207|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564208|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564209|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564210|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity..
564211|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
572633|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
564212|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564213|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564214|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564215|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564216|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564217|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564218|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564219|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564220|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564221|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564222|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564223|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564224|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564225|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564226|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564227|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564228|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564229|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564230|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564231|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564232|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564233|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564234|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564235|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564236|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564237|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564238|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564239|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564240|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564241|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564242|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564243|NCT00893464|O1|Outcome|All Participants|All participants who received MLN9708 at dose 0.125 mg/m^2, 0.25 mg/m^2, 0.5 mg/m^2, 1.0 mg/m^2, 1.4 mg/m^2, 1.76 mg/m^2, 2.34 mg/m^2 and 3.11 mg/m^2 in Phase 1.
564244|NCT00893464|O1|Outcome|All Participants|All participants who received ixazomib (MLN9708) 0.125 mg/m^2, 0.25 mg/m^2, 0.5 mg/m^2, 1.0 mg/m^2, 1.4 mg/m^2, 1.76 mg/m^2, 2.34 mg/m^2 or 3.11 mg/m^2 in dose-escalation cohorts .
564245|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564246|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564247|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564248|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564249|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564250|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564251|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564252|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564253|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564254|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564255|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564256|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564257|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564258|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564259|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564260|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564261|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m²|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564262|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564263|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564264|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564265|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564266|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564267|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564268|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564269|NCT00893464|E8|Reported Event|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564270|NCT00893464|E7|Reported Event|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564271|NCT00893464|E6|Reported Event|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564272|NCT00893464|E5|Reported Event|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564273|NCT00893464|E4|Reported Event|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564274|NCT00893464|E3|Reported Event|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564275|NCT00893464|E2|Reported Event|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564276|NCT00893464|E1|Reported Event|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
564277|NCT00893737|B1|Baseline|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
564278|NCT00893737|P1|Participant Flow|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
564331|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564279|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
564280|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
564281|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
564282|NCT00893737|E1|Reported Event|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
564283|NCT00893763|B3|Baseline|Total|Total of all reporting groups
564284|NCT00893763|B2|Baseline|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
564285|NCT00893763|B1|Baseline|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
564286|NCT00893763|P2|Participant Flow|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
564287|NCT00893763|P1|Participant Flow|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
564288|NCT00893763|O2|Outcome|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
564289|NCT00893763|O1|Outcome|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
564290|NCT00893763|O2|Outcome|2: COntrol|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
564291|NCT00893763|O1|Outcome|1: Preintubation Intervention|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
564292|NCT00893763|E2|Reported Event|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
564293|NCT00893763|E1|Reported Event|1: Intervention|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
564294|NCT00893789|B5|Baseline|Total|Total of all reporting groups
564295|NCT00893789|B4|Baseline|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564296|NCT00893789|B3|Baseline|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564297|NCT00893789|B2|Baseline|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564298|NCT00893789|B1|Baseline|Placebo|Oral placebo tablets, once daily (QD)
564299|NCT00893789|P4|Participant Flow|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564300|NCT00893789|P3|Participant Flow|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564301|NCT00893789|P2|Participant Flow|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564302|NCT00893789|P1|Participant Flow|Placebo|Oral placebo tablets, once daily (QD)
564303|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564304|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564305|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564306|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564307|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564308|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564309|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564310|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564311|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564312|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564313|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564314|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564315|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564316|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564317|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564318|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564319|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564320|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564321|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564322|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564323|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564324|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564325|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564326|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564327|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564328|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564329|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564330|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564336|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564337|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564338|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564339|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564340|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564341|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564342|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564343|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564344|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564345|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564346|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564347|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564348|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564349|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564350|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564351|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564352|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564353|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564354|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564355|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564356|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564357|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564358|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564359|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564360|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564361|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564362|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564363|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564364|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564365|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564366|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564367|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564368|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564369|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564370|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564371|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564372|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564373|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564374|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564375|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564376|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564377|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564378|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
564379|NCT00893789|E4|Reported Event|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
564380|NCT00893789|E3|Reported Event|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
564381|NCT00893789|E2|Reported Event|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
564382|NCT00893789|E1|Reported Event|Placebo|Oral placebo tablets, once daily (QD)
564383|NCT00893971|B1|Baseline|All Subjects|Any treatment arm
564384|NCT00893971|P1|Participant Flow|Overall Study|All patients randomized
564385|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564386|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564387|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564388|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564389|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564390|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564391|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564392|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564393|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564394|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564395|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564396|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564397|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564398|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564399|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564400|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564401|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564402|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564403|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564404|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564405|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564406|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564407|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564408|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564409|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564410|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564411|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564412|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564413|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564414|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564415|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564416|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564417|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564418|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564419|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564420|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564421|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564422|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564423|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564424|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564425|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564426|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564427|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564428|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564429|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564430|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564431|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564432|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564433|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564434|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564435|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564436|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564437|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564438|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564439|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564440|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564441|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564442|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564443|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564444|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564445|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564446|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564447|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564448|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564449|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564450|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564451|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564452|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564453|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564454|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564455|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564456|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564457|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564458|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564459|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564460|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564461|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564462|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564463|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564464|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564465|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564466|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564467|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564468|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564469|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564470|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564471|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564472|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564473|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564474|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564475|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564476|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564477|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564478|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564479|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564480|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564481|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564482|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564483|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564484|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564485|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564486|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564487|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564488|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564489|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564490|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564491|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564492|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564493|NCT00893971|E4|Reported Event|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
564494|NCT00893971|E3|Reported Event|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
564495|NCT00893971|E2|Reported Event|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
564496|NCT00893971|E1|Reported Event|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
564497|NCT00893997|B1|Baseline|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
564498|NCT00893997|P1|Participant Flow|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
564499|NCT00893997|O1|Outcome|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
564500|NCT00893997|O1|Outcome|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
564501|NCT00893997|E1|Reported Event|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
564502|NCT00894127|B1|Baseline|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
564503|NCT00894127|P1|Participant Flow|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
564504|NCT00894127|O1|Outcome|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|"Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum"
564505|NCT00894127|E1|Reported Event|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|"Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum"
564506|NCT00894166|B9|Baseline|Total|Total of all reporting groups
564507|NCT00894166|B8|Baseline|Withdrew Prior to Randomization|These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.
564508|NCT00894166|B7|Baseline|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
564509|NCT00894166|B6|Baseline|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
564684|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
564510|NCT00894166|B5|Baseline|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
564511|NCT00894166|B4|Baseline|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
564512|NCT00894166|B3|Baseline|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
564513|NCT00894166|B2|Baseline|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
564514|NCT00894166|B1|Baseline|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
564515|NCT00894166|P8|Participant Flow|Withdrew Prior to Randomization|"These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.
21mg (1 patch) or 42mg (2 patches) nicotine patches were dispensed for the first week of study participation during the one session they completed."
564516|NCT00894166|P7|Participant Flow|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
564517|NCT00894166|P6|Participant Flow|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
564518|NCT00894166|P5|Participant Flow|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
564519|NCT00894166|P4|Participant Flow|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
564520|NCT00894166|P3|Participant Flow|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
564521|NCT00894166|P2|Participant Flow|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
564522|NCT00894166|P1|Participant Flow|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
564523|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
564524|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
564639|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
564525|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
564526|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
564527|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
564528|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
564529|NCT00894166|O1|Outcome|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
564530|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
564531|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
564532|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
564533|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
564534|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
564535|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
564685|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
564536|NCT00894166|O1|Outcome|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
564537|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
564538|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
564539|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
564540|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
564541|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
564542|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
564543|NCT00894166|O1|Outcome|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
564544|NCT00894166|E7|Reported Event|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
564545|NCT00894166|E6|Reported Event|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
564546|NCT00894166|E5|Reported Event|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
564547|NCT00894166|E4|Reported Event|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
564548|NCT00894166|E3|Reported Event|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
564549|NCT00894166|E2|Reported Event|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
564550|NCT00894166|E1|Reported Event|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
564551|NCT00894244|B1|Baseline|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
564552|NCT00894244|P1|Participant Flow|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
564553|NCT00894244|O1|Outcome|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
564554|NCT00894244|E1|Reported Event|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
564555|NCT00888433|B3|Baseline|Total|Total of all reporting groups
564556|NCT00888433|B2|Baseline|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
564557|NCT00888433|B1|Baseline|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
564558|NCT00888433|P2|Participant Flow|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
564559|NCT00888433|P1|Participant Flow|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
564560|NCT00888433|O2|Outcome|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
564561|NCT00888433|O1|Outcome|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
564562|NCT00888433|E2|Reported Event|2. CONTROL|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
564563|NCT00888433|E1|Reported Event|1. DENERVATION|Renal Denervation and maintenance of anti-hypertensive medications
564564|NCT00888459|B3|Baseline|Total|Total of all reporting groups
564565|NCT00888459|B2|Baseline|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
564566|NCT00888459|B1|Baseline|Active|4 mg nicotine lozenges
564567|NCT00888459|P2|Participant Flow|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
564568|NCT00888459|P1|Participant Flow|Active|4 mg nicotine lozenges
564569|NCT00888459|O2|Outcome|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
564570|NCT00888459|O1|Outcome|Active|4 mg nicotine lozenges
564571|NCT00888459|E2|Reported Event|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
564572|NCT00888459|E1|Reported Event|Active|4 mg nicotine lozenges
564573|NCT00894322|B4|Baseline|Total|Total of all reporting groups
564574|NCT00894322|B3|Baseline|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564575|NCT00894322|B2|Baseline|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.
564576|NCT00894322|B1|Baseline|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564577|NCT00894322|P3|Participant Flow|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564578|NCT00894322|P2|Participant Flow|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.
564579|NCT00894322|P1|Participant Flow|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564580|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564581|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564582|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564583|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564584|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564585|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564586|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564587|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564588|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564589|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564590|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564591|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564592|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564593|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564594|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564595|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564596|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564597|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564598|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564599|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564600|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564601|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564602|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564603|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564604|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564605|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564606|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564607|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564608|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564609|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564640|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
564610|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564611|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564612|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564613|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564614|NCT00894322|E3|Reported Event|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564615|NCT00894322|E2|Reported Event|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
564616|NCT00894322|E1|Reported Event|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
564617|NCT00894361|B3|Baseline|Total|Total of all reporting groups
564618|NCT00894361|B2|Baseline|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
564619|NCT00894361|B1|Baseline|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design
564620|NCT00894361|P2|Participant Flow|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
564621|NCT00894361|P1|Participant Flow|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing TKA design
564622|NCT00894361|O2|Outcome|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
564623|NCT00894361|O1|Outcome|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing TKA design
564624|NCT00894361|E2|Reported Event|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
564625|NCT00894361|E1|Reported Event|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design
564626|NCT00894387|B3|Baseline|Total|Total of all reporting groups
564627|NCT00894387|B2|Baseline|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
564628|NCT00894387|B1|Baseline|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
564629|NCT00894387|P2|Participant Flow|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
564630|NCT00894387|P1|Participant Flow|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
564631|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
564632|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
564633|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
564634|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
564635|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
564636|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
564637|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
564638|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
564747|NCT00895531|O2|Outcome|Depodur Group|
564641|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
564642|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
564643|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
564644|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
564645|NCT00894387|E2|Reported Event|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
564646|NCT00894387|E1|Reported Event|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
564647|NCT00894465|B3|Baseline|Total|Total of all reporting groups
564648|NCT00894465|B2|Baseline|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.
placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
564649|NCT00894465|B1|Baseline|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.
midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
564650|NCT00894465|P2|Participant Flow|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.
placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
564651|NCT00894465|P1|Participant Flow|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.
midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
564652|NCT00894465|O2|Outcome|Placebo|Parents of patients who were given oral placebo prior to undergoing the VCUG.
564653|NCT00894465|O1|Outcome|Versed|Parents of patients who were given oral midazolam prior to undergoing the VCUG.
564654|NCT00894465|O2|Outcome|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.
placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
564655|NCT00894465|O1|Outcome|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.
midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
564656|NCT00894465|E2|Reported Event|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.
placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
564657|NCT00894465|E1|Reported Event|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.
midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
564658|NCT00894504|B1|Baseline|Panitumumab/Gemcitabine/Carboplatin|Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
564659|NCT00894504|P1|Participant Flow|Panitumumab/Gemcitabine/Carboplatin|"Treatment cycles are repeated every 14 days (2 weeks)
Panitumumab: 6mg/kg intravenous (IV), Day 1 of each 2-week treatment cycle.
Gemcitabine: 1500mg/m2 IV, Day 1 of each 2-week treatment cycle
Carboplatin: Area Under the Curve (AUC) = 2.5 IV, Day 1 of each 2-week treatment cycle"
564660|NCT00894504|O8|Outcome|PIK3CA Mutation(s)|
564661|NCT00894504|O7|Outcome|PIK3CA No Mutation|
564662|NCT00894504|O6|Outcome|PTEN Loss|
564663|NCT00894504|O5|Outcome|PTEN Normal|
564664|NCT00894504|O4|Outcome|p53 Loss|
564665|NCT00894504|O3|Outcome|p53 Normal|
564666|NCT00894504|O2|Outcome|EGFR Amplified|
564667|NCT00894504|O1|Outcome|EGFR Normal|
564668|NCT00894504|O1|Outcome|Arm/Group 1|
564669|NCT00894504|O1|Outcome|Panitumumab/Gemcitabine/Carboplatin|Systemic therapy
564670|NCT00894504|O1|Outcome|Panitumumab/Gemcitabine/Carboplatin|Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
564671|NCT00894504|E1|Reported Event|Panitumumab/Gemcitabine/Carboplatin|
564672|NCT00894517|B3|Baseline|Total|Total of all reporting groups
564673|NCT00894517|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
564674|NCT00894517|B1|Baseline|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
564675|NCT00894517|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
564676|NCT00894517|P1|Participant Flow|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
564677|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
564678|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
564679|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
564680|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
564681|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
564682|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
564683|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
564686|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
564687|NCT00894517|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
564688|NCT00894517|E1|Reported Event|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
564689|NCT00894543|B3|Baseline|Total|Total of all reporting groups
564690|NCT00894543|B2|Baseline|Placebo|Inactive pill
564691|NCT00894543|B1|Baseline|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564692|NCT00894543|P2|Participant Flow|Placebo|Inactive pill
564693|NCT00894543|P1|Participant Flow|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564694|NCT00894543|O2|Outcome|Placebo|Inactive pill
564695|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564696|NCT00894543|O2|Outcome|Placebo|Inactive pill
564697|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564698|NCT00894543|O2|Outcome|Placebo|Inactive pill
564699|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564700|NCT00894543|O2|Outcome|Placebo|Inactive pill
564701|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564702|NCT00894543|O2|Outcome|Placebo|Inactive pill
564703|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564704|NCT00894543|O2|Outcome|Placebo|Inactive pill
564705|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564706|NCT00894543|O2|Outcome|Placebo|Inactive pill
564707|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564708|NCT00894543|O2|Outcome|Placebo|Inactive pill
564709|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564710|NCT00894543|O2|Outcome|Placebo|Inactive pill
564711|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564712|NCT00894543|E2|Reported Event|Placebo|Inactive pill
564748|NCT00895531|O1|Outcome|Peripheral Nerve Group|
564713|NCT00894543|E1|Reported Event|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
564714|NCT00894556|B4|Baseline|Total|Total of all reporting groups
564715|NCT00894556|B3|Baseline|Placebo / Rizatriptan / Rizatriptan|The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT
564716|NCT00894556|B2|Baseline|Rizatriptan / Placebo / Rizatriptan|The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT.
564717|NCT00894556|B1|Baseline|Rizatriptan / Rizatriptan / Placebo|The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo.
564718|NCT00894556|P4|Participant Flow|Sumatriptan 100 mg|Pre-Randomization Phase conducted 2 months prior to Study Randomization. Eligible participants were to treat a moderate/severe migraine attack with sumatriptan 100 mg. Those who failed to respond to sumatriptan (i.e. continued to experience moderate or severe pain at 2 hours post dose) were classified as non-responders and were entered into the double-blind treatment phase of the study.
564719|NCT00894556|P3|Participant Flow|Placebo / Rizatriptan / Rizatriptan|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were
then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one
with placebo.
The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT"
564720|NCT00894556|P2|Participant Flow|Rizatriptan / Placebo / Rizatriptan|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were
then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one
with placebo.
The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT."
564721|NCT00894556|P1|Participant Flow|Rizatriptan / Rizatriptan / Placebo|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were
then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one
with placebo.
The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo."
564722|NCT00894556|O2|Outcome|Placebo|Migraines were treated with placebo
564723|NCT00894556|O1|Outcome|Rizatriptan|"Migraines were treated with Rizatriptan 10 mg ODT.
Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups."
564724|NCT00894556|O2|Outcome|Placebo|Migraines were treated with placebo
564725|NCT00894556|O1|Outcome|Rizatriptan|"Migraines were treated with Rizatriptan 10 mg ODT.
Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups."
564726|NCT00894556|E3|Reported Event|Sumatriptan 100 mg|"Adverse Events that occurred in the Baseline Phase (prior to taking study medication) are identified in the tables as Baseline Phase"
564727|NCT00894556|E2|Reported Event|Placebo|
564728|NCT00894556|E1|Reported Event|Rizatriptan 10 mg|"Patients took at least one dose of study medication. It is possible for one patient to be counted twice (once in each treatment group).
Although a patient may have had two or more adverse events of the same type, the patient is counted only once for that type of adverse event.
Adverse events occurring within 14 days of administration of Rizatriptan 10 mg are attributed to Rizatriptan 10 mg group even if placebo was administered more recently."
564729|NCT00895453|B4|Baseline|Total|Total of all reporting groups
564730|NCT00895453|B3|Baseline|Classic Homeopathy|
564731|NCT00895453|B2|Baseline|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
564732|NCT00895453|B1|Baseline|Itraconazole|itraconazole alone
564733|NCT00895453|P3|Participant Flow|Classic Homeopathy|
564734|NCT00895453|P2|Participant Flow|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
564735|NCT00895453|P1|Participant Flow|Itraconazole|itraconazole alone
564736|NCT00895453|O3|Outcome|Classic Homeopathy|
564737|NCT00895453|O2|Outcome|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
564738|NCT00895453|O1|Outcome|Itraconazole|itraconazole alone
564739|NCT00895453|E3|Reported Event|Classic Homeopathy (CH)|"CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.
classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed): CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000."
564740|NCT00895453|E2|Reported Event|Itraconazole + Lactobacilli Agent|"6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.
itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)
lactobacillus gasseri: Lactobacillus vaginal tablets monthly given through 6 days"
564741|NCT00895453|E1|Reported Event|Itraconazole|"6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).
itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)"
564742|NCT00895531|B3|Baseline|Total|Total of all reporting groups
564743|NCT00895531|B2|Baseline|Depodur Group|
564744|NCT00895531|B1|Baseline|Peripheral Nerve Group|
564745|NCT00895531|P2|Participant Flow|Depodur Group|
564746|NCT00895531|P1|Participant Flow|Peripheral Nerve Group|
564752|NCT00895583|B2|Baseline|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564753|NCT00895583|B1|Baseline|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564754|NCT00895583|P2|Participant Flow|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564755|NCT00895583|P1|Participant Flow|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564756|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564757|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564758|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564759|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564760|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564836|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional
rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
564845|NCT00895752|O1|Outcome|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
564761|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564762|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564763|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564764|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564765|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564766|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564767|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564768|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564769|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564846|NCT00895752|O1|Outcome|Riluzole|6 subjects received open label riluzole, maximum dose of 50mg bid.
564770|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564771|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564772|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564773|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564774|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564775|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564776|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564777|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564778|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564837|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional
rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
564847|NCT00895752|O1|Outcome|Riluzole|6 subjects received open label riluzole, maximum dose of 50mg bid.
572634|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
564779|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564780|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564781|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564782|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564783|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564784|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564785|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564786|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564787|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564848|NCT00895752|O1|Outcome|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
564788|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564789|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564790|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564791|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564792|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564793|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564794|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564795|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564796|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564838|NCT00895661|E1|Reported Event|Rituximab|"single-arm, open-label, interventional
rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
564839|NCT00895752|B1|Baseline|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
564797|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564798|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564799|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564800|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564801|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564802|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564803|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564804|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564805|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564840|NCT00895752|P1|Participant Flow|Riluzole|6 subjects received open label riluzole, maximum dose of 50mg bid.
564806|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564807|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564808|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564809|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564810|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564811|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564812|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564813|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564814|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564841|NCT00895752|O1|Outcome|Riluzole|Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
564842|NCT00895752|O1|Outcome|Riluzole|Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
564843|NCT00895752|O1|Outcome|Riluzole|Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
572635|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
564815|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564816|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564817|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564818|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564819|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564820|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564821|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564822|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564823|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564844|NCT00895752|O1|Outcome|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
564824|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564825|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564826|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564827|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564828|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564829|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564830|NCT00895583|E2|Reported Event|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564831|NCT00895583|E1|Reported Event|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
564832|NCT00895661|B1|Baseline|Rituximab|"single-arm, open-label, interventional
rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
564833|NCT00895661|P1|Participant Flow|Rituximab|"single-arm, open-label, interventional
rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
564834|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional
rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
564835|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional
rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
564849|NCT00895752|E1|Reported Event|Riluzole|"Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
Riluzole: Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day."
564850|NCT00895817|B3|Baseline|Total|Total of all reporting groups
564851|NCT00895817|B2|Baseline|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
564852|NCT00895817|B1|Baseline|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
564853|NCT00895817|P2|Participant Flow|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
564854|NCT00895817|P1|Participant Flow|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
564855|NCT00895817|O2|Outcome|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
564856|NCT00895817|O1|Outcome|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
564857|NCT00895817|E2|Reported Event|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
564858|NCT00895817|E1|Reported Event|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
564859|NCT00895830|B6|Baseline|Total|Total of all reporting groups
564860|NCT00895830|B5|Baseline|APD405 3mg Dose|
564861|NCT00895830|B4|Baseline|APD405 2mg Dose|
564862|NCT00895830|B3|Baseline|APD405 1mg Dose|
564863|NCT00895830|B2|Baseline|APD405 0.3mg Dose|
564864|NCT00895830|B1|Baseline|Placebo|
564865|NCT00895830|P5|Participant Flow|APD405 3mg Dose|
564866|NCT00895830|P4|Participant Flow|APD405 2mg Dose|
564867|NCT00895830|P3|Participant Flow|APD405 1mg Dose|
564868|NCT00895830|P2|Participant Flow|APD405 0.3mg Dose|
564869|NCT00895830|P1|Participant Flow|Placebo|
564870|NCT00895830|O5|Outcome|APD405 3mg Dose|
564871|NCT00895830|O4|Outcome|APD405 2mg Dose|
564872|NCT00895830|O3|Outcome|APD405 1mg Dose|
564873|NCT00895830|O2|Outcome|APD405 0.3mg Dose|
564874|NCT00895830|O1|Outcome|Placebo|
564875|NCT00895830|E5|Reported Event|APD405 3mg Dose|
564876|NCT00895830|E4|Reported Event|APD405 2mg Dose|
564877|NCT00895830|E3|Reported Event|APD405 1mg Dose|
564878|NCT00895830|E2|Reported Event|APD405 0.3mg Dose|
564879|NCT00895830|E1|Reported Event|Placebo|
564880|NCT00895843|B3|Baseline|Total|Total of all reporting groups
564881|NCT00895843|B2|Baseline|Brufen Retard|
564882|NCT00895843|B1|Baseline|Conventional Ibuprofen|
564883|NCT00895843|P2|Participant Flow|Brufen Retard|
564884|NCT00895843|P1|Participant Flow|Conventional Ibuprofen|
564885|NCT00895843|O2|Outcome|Brufen Retard|
564886|NCT00895843|O1|Outcome|Conventional Ibuprofen|
564887|NCT00895843|E2|Reported Event|Brufen Retard|
564888|NCT00895843|E1|Reported Event|Conventional Ibuprofen|
564889|NCT00895895|B6|Baseline|Total|Total of all reporting groups
564890|NCT00895895|B5|Baseline|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564891|NCT00895895|B4|Baseline|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564892|NCT00895895|B3|Baseline|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564893|NCT00895895|B2|Baseline|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564894|NCT00895895|B1|Baseline|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564895|NCT00895895|P5|Participant Flow|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564896|NCT00895895|P4|Participant Flow|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564897|NCT00895895|P3|Participant Flow|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564898|NCT00895895|P2|Participant Flow|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565024|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
564899|NCT00895895|P1|Participant Flow|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564900|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564901|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564902|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564903|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564904|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564905|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564906|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564907|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564908|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564909|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564910|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564911|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564912|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564913|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564914|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564915|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
572636|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
564916|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564917|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564918|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564919|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564920|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564921|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564922|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564923|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564924|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564925|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564926|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564927|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564928|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564929|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564930|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564931|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564932|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565025|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
572637|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
564933|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564934|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564935|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564936|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564937|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564938|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564939|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564940|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564941|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564942|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564943|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564944|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564945|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564946|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564947|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564948|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564949|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
572638|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
564950|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564951|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564952|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564953|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564954|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564955|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564956|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564957|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564958|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564959|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564960|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564961|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564962|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564963|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564964|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564965|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564966|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565026|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
565028|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
564967|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564968|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564969|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564970|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564971|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564972|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564973|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564974|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564975|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564976|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564977|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564978|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564979|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564980|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564981|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564982|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564983|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565027|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
565197|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
564984|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564985|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564986|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564987|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564988|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564989|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564990|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564991|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564992|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564993|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564994|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564995|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564996|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564997|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564998|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
564999|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565000|NCT00895895|E10|Reported Event|Donepezil Period 2|Matching SAM-531 placebo capsule administered QD (morning dose) for up to 52 weeks. One encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) from Week 25 up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion and according to tolerance.
565001|NCT00895895|E9|Reported Event|SAM-531 5.0 mg Period 2|SAM-531 5.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565002|NCT00895895|E8|Reported Event|SAM-531 3.0 mg Period 2|SAM-531 3.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565003|NCT00895895|E7|Reported Event|SAM-531 1.5 mg Period 2|SAM-531 1.5 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565004|NCT00895895|E6|Reported Event|SAM-531 5.0 mg Crossover Period 2|Participants who received Placebo in Period 1, beginning in Week 25 and up to Week 52 (Period 2) received SAM-531 5.0 mg capsule administered QD (morning dose) and matching encapsulated Donepezil placebo tablet administered QD (evening dose). The evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565005|NCT00895895|E5|Reported Event|Donepezil Period 1|Matching SAM-531 placebo capsule administered QD (morning dose) and 1 encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion and according to tolerance.
565006|NCT00895895|E4|Reported Event|SAM-531 5.0 mg Period 1|SAM-531 5.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565007|NCT00895895|E3|Reported Event|SAM-531 3.0 mg Period 1|SAM-531 3.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565008|NCT00895895|E2|Reported Event|SAM-531 1.5 mg Period 1|SAM-531 1.5 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565009|NCT00895895|E1|Reported Event|Placebo/5.0 mg Period 1|Matching SAM-531 placebo capsule administered QD (morning dose) and one encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 24 weeks (Period 1). From Week 7 the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
565010|NCT00895934|B3|Baseline|Total|Total of all reporting groups
565011|NCT00895934|B2|Baseline|Phase 2/Selected Dose|Azacitidine 75 mg/m2 SC or IV on days 1-7, vorinostat 400 mg qd po on days 1-9, gemtuzumab ozogamicin 3 mg/m2 IV on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
565012|NCT00895934|B1|Baseline|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
gemtuzumab ozogamicin: Given IV
azacitidine: Given IV or SC
laboratory biomarker analysis: Correlative studies"
565013|NCT00895934|P2|Participant Flow|Phase 2/Selected Dose|Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.
565014|NCT00895934|P1|Participant Flow|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat orally on days 1-9, azacitidine subcutaneously (SC) or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
gemtuzumab ozogamicin: Given IV
azacitidine: Given IV or SC
laboratory biomarker analysis: Correlative studies"
565015|NCT00895934|O2|Outcome|Phase 2/Selected Dose|Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.
565016|NCT00895934|O1|Outcome|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
gemtuzumab ozogamicin: Given IV
azacitidine: Given IV or SC
laboratory biomarker analysis: Correlative studies"
565017|NCT00895934|E2|Reported Event|Phase 2/Selected Dose|"Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.
Laboratory biomarker analysis: correlative studies"
565018|NCT00895934|E1|Reported Event|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis: correlative studies"
565019|NCT00895947|B3|Baseline|Total|Total of all reporting groups
565020|NCT00895947|B2|Baseline|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
565021|NCT00895947|B1|Baseline|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
565022|NCT00895947|P2|Participant Flow|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
565023|NCT00895947|P1|Participant Flow|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
565029|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
565030|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
565031|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
565032|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
565033|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
565034|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
565035|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
565036|NCT00895947|E2|Reported Event|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
565037|NCT00895947|E1|Reported Event|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
565038|NCT00896025|B1|Baseline|N-acetycylcysteine|Each eligible Acute Liver Failure patient will be given N-acetylcysteine (NAC), beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, followed by 50 mg/kg in 500 ml 5% dextrose over four hours, and 125 mg/kg in 1000 ml 5% dextrose over 19 hours, then 150 mg/kg in 1000 ml 5% dextrose per 24 hours for an additional 48 hours. The patient will be on continuous NAC infusion for a total of 72 hours.
565039|NCT00896025|P1|Participant Flow|N-acetycylcysteine|Acute liver failure population
565040|NCT00896025|O1|Outcome|N-acetycylcysteine|"Acute liver failure population
N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.
NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.
i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour
ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours
iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours
iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours
v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours"
565041|NCT00896025|E1|Reported Event|N-acetycylcysteine|"Acute liver failure population
N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.
NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.
i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour
ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours
iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours
iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours
v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours"
565042|NCT00896038|B3|Baseline|Total|Total of all reporting groups
565043|NCT00896038|B2|Baseline|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
565044|NCT00896038|B1|Baseline|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565045|NCT00896038|P2|Participant Flow|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
565046|NCT00896038|P1|Participant Flow|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565047|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565048|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565049|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565050|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565051|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565052|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565053|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565054|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565055|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565056|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565057|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565058|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565059|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565060|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565061|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565062|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565063|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565064|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565065|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565066|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565067|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565068|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565069|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565070|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565071|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565072|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565073|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565074|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565075|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565076|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565077|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565078|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565079|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
565080|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565081|NCT00896038|E2|Reported Event|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
565082|NCT00896038|E1|Reported Event|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
565083|NCT00896051|B3|Baseline|Total|Total of all reporting groups
565084|NCT00896051|B2|Baseline|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
565085|NCT00896051|B1|Baseline|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
565086|NCT00896051|P2|Participant Flow|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
565087|NCT00896051|P1|Participant Flow|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
565088|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
565089|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
565090|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
565091|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
565092|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
565093|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
565094|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
565095|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
565198|NCT00896233|E1|Reported Event|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
565096|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
565097|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
565098|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
565099|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
565100|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
565101|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
565102|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
565103|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
565104|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
565105|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
565106|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
565107|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
565108|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
565109|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
565110|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for rtv provided in the table below are at Week 2.
565111|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
565112|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
565113|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
565114|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
565115|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
565116|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
565117|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
565118|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
565119|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
565120|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
565121|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
565122|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
565123|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
565124|NCT00896051|E2|Reported Event|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
565125|NCT00896051|E1|Reported Event|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
565126|NCT00896064|B3|Baseline|Total|Total of all reporting groups
565127|NCT00896064|B2|Baseline|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565128|NCT00896064|B1|Baseline|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565129|NCT00896064|P2|Participant Flow|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565130|NCT00896064|P1|Participant Flow|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565131|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565132|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565133|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565134|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565135|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565136|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565137|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565138|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565139|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565140|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565141|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565142|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565143|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565144|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565145|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565146|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565147|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565148|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565149|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565150|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565151|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565152|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565252|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565153|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565154|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565155|NCT00896064|E2|Reported Event|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565156|NCT00896064|E1|Reported Event|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
565157|NCT00896168|B3|Baseline|Total|Total of all reporting groups
565158|NCT00896168|B2|Baseline|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565159|NCT00896168|B1|Baseline|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565160|NCT00896168|P2|Participant Flow|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565161|NCT00896168|P1|Participant Flow|Infliximab + Methotrexate (Moderate Rheumatoid Arthritis [RA])|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activitiy score [DAS] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565162|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565163|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565164|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565165|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565166|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565167|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565168|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565169|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565170|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565171|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565199|NCT00896337|B1|Baseline|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
572639|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
565172|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565173|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565174|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565175|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565176|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565177|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565178|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565179|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565180|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565181|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565182|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565183|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565184|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565185|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565186|NCT00896168|E2|Reported Event|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
565187|NCT00896168|E1|Reported Event|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
565188|NCT00896233|B1|Baseline|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
565189|NCT00896233|P1|Participant Flow|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
565190|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
565191|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
565192|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
565193|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
565194|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
565195|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
565196|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
565200|NCT00896337|P1|Participant Flow|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
565201|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565202|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565203|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565204|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565205|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565206|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565207|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565208|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565209|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565210|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565211|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565212|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565213|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565214|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565215|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565216|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565217|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565218|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565219|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565220|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565221|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565222|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565223|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565224|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565225|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565226|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565227|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565228|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565229|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565230|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565231|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565232|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565233|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565234|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent
565235|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent
565236|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
565237|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
565238|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
565239|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565240|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565241|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565242|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565243|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565244|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565245|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565246|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565247|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565248|NCT00896337|O1|Outcome|Epis Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
565249|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565250|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565251|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
572640|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
565253|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565254|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565255|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565256|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565257|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565258|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565259|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565260|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565261|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565262|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565263|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565264|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
565265|NCT00896337|E1|Reported Event|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
565266|NCT00896454|B1|Baseline|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565267|NCT00896454|P1|Participant Flow|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565268|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565269|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565270|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565271|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565272|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565273|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565274|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565275|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565276|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565277|NCT00896454|E1|Reported Event|Denosumab 120 mg Q4W|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
565278|NCT00896649|B1|Baseline|Positron Emission Mammography (PEM), Mammography, Questionaire|"questionnaire administration digital mammography positron emission mammography
questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.
digital mammography: standard screening mammogram
positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram"
565279|NCT00896649|P1|Participant Flow|Single Arm Positron Emission Mamm, Mammogram and Questionnaire|"questionnaire administration positron emission mammography
digital mammography: standard screening mammogram
questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.
positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
565280|NCT00896649|O1|Outcome|Single Arm Positron Emission Mammo, Mammogram & Questionnaire|"questionnaire administration positron emission mammography
digital mammography: standard screening mammogram
questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.
positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
565281|NCT00896649|O1|Outcome|Single Arm Positron Emission Mammography and Questionnaire|"questionnaire administration positron emission mammography
digital mammography: standard screening mammogram
questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.
positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram"
565282|NCT00896649|E1|Reported Event|Single Arm PEM, Mammography and Questionnaire|"questionnaire administration positron emission mammography
digital mammography: standard screening mammogram
questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.
positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
565283|NCT00896779|B3|Baseline|Total|Total of all reporting groups
565284|NCT00896779|B2|Baseline|Ranibizumab Group 2|Group 2: 6 monthly injecions of 0.5mg then prn
565285|NCT00896779|B1|Baseline|Ranibizumab Group 1|Group 1: 3 monthly injections of 0.5mg then prn
565286|NCT00896779|P2|Participant Flow|Ranibizumab Group 2|Group 1: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
565287|NCT00896779|P1|Participant Flow|Ranibizumab Group 1|Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
565288|NCT00896779|O2|Outcome|Ranibizumab Group 2|Group 2: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
565289|NCT00896779|O1|Outcome|Ranibizumab Group 1|Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
565290|NCT00896779|E2|Reported Event|Ranibizumab Group 2|Group 2: 6 monthly injections of 0.5 mg then prn
565291|NCT00896779|E1|Reported Event|Ranibizumab Group 1|Group 1: 3 monthly injections of 0.5mg then prn
565292|NCT00897104|B4|Baseline|Total|Total of all reporting groups
565293|NCT00897104|B3|Baseline|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
565294|NCT00897104|B2|Baseline|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
565295|NCT00897104|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565296|NCT00897104|P3|Participant Flow|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
565297|NCT00897104|P2|Participant Flow|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
565298|NCT00897104|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565299|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
565300|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
565301|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565302|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
565303|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
565304|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565305|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
565306|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
565307|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565308|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
565309|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
565310|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565311|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
565312|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
565313|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565314|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
565315|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
565316|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565317|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
565318|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
565319|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565320|NCT00897104|E3|Reported Event|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
565321|NCT00897104|E2|Reported Event|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
565322|NCT00897104|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565323|NCT00897390|B1|Baseline|All Enrolled and Treated Participants|
565324|NCT00897390|P1|Participant Flow|All Treated Participants|Participants were assigned to 1 of 4 treatment sequences (A-D-B-C, B-A-C-D, C-B-D-A, D-C-A-B). Treatment A=2.5-mg saxagliptin tablet co-administered with 1000-mg metformin IR tablet, fasted; Treatment B=fixed-dose combination (FDC) tablet of 2.5-mg saxagliptin/1000-mg metformin immediate release (IR), fasted; Treatment C=2.5-mg saxagliptin tablet co-administered with 1000-mg metformin IR tablet, fed; Treatment D=FDC tablet of 2.5-mg saxagliptin/1000-mg metformin IR, fed. The washout between each dose was at least 7 days.
565325|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565326|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565327|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565328|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565329|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565330|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565331|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565332|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565432|NCT00897949|B2|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
565333|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565334|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565335|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565336|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565337|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565338|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565339|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565340|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565341|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565342|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565343|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565344|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565345|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565346|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565347|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565348|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565349|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565350|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565351|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565352|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565353|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565354|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565355|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565356|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565357|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565358|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565359|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565360|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565361|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565362|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565363|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565364|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565433|NCT00897949|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565365|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565366|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565367|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565368|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565369|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565370|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565371|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565372|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565373|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565374|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565375|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565376|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565377|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565378|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565379|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565380|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565381|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565382|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565383|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565384|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565385|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565386|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565387|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565388|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565389|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565390|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565391|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565392|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565393|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565394|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565395|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565396|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565434|NCT00897949|P3|Participant Flow|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
565397|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565398|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565399|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565400|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565401|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
565402|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
565403|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565404|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
565405|NCT00897390|E5|Reported Event|Not Dosed|58 participants were enrolled in the study; 34 participants were not dosed (23 no longer met study criteria, 4 withdrew consent, and 7 for other reasons).
565406|NCT00897390|E4|Reported Event|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal.
565407|NCT00897390|E3|Reported Event|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal.
565408|NCT00897390|E2|Reported Event|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
565409|NCT00897390|E1|Reported Event|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions.
565410|NCT00897715|B3|Baseline|Total|Total of all reporting groups
565411|NCT00897715|B2|Baseline|Placebo|"matching placebo
Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
565412|NCT00897715|B1|Baseline|Interleukin-1 Receptor Antagonist|"active drug
Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
565413|NCT00897715|P2|Participant Flow|Placebo|"matching placebo
Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
565414|NCT00897715|P1|Participant Flow|Interleukin-1 Receptor Antagonist|"active drug
Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
565415|NCT00897715|O2|Outcome|Placebo|"matching placebo
Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
565416|NCT00897715|O1|Outcome|Interleukin-1 Receptor Antagonist|"active drug
Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
565417|NCT00897715|O2|Outcome|Placebo|"matching placebo
Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
565418|NCT00897715|O1|Outcome|Interleukin-1 Receptor Antagonist|"active drug
Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
565419|NCT00897715|E2|Reported Event|Placebo|"matching placebo
Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
565420|NCT00897715|E1|Reported Event|Interleukin-1 Receptor Antagonist|"active drug
Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
565421|NCT00897897|B1|Baseline|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.
Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
565422|NCT00897897|P1|Participant Flow|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.
Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
565423|NCT00897897|O1|Outcome|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.
Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
565424|NCT00897897|O1|Outcome|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.
Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
565425|NCT00897897|E1|Reported Event|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.
Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
565426|NCT00897910|B1|Baseline|Collection of Circulating Blood and Bone Marrow.|
565427|NCT00897910|P1|Participant Flow|Collection of Circulating Blood and Bone Marrow.|
565428|NCT00897910|O1|Outcome|Collection of Blood and Bone Marrow.|
565429|NCT00897910|E1|Reported Event|Collection of Circulating Blood and Bone Marrow.|
565430|NCT00897949|B4|Baseline|Total|Total of all reporting groups
565431|NCT00897949|B3|Baseline|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
565435|NCT00897949|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
565436|NCT00897949|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565437|NCT00897949|O6|Outcome|Placebo / Rizatriptan 10 mg|Placebo initially, prerandomized to rizatriptan 10 mg
565438|NCT00897949|O5|Outcome|Placebo / Rizatriptan 5 mg|Placebo initially, prerandomized to rizatriptan 5 mg
565439|NCT00897949|O4|Outcome|Rizatriptan 10 mg / Placebo|Rizatriptan 10 mg initially, prerandomized to placebo
565440|NCT00897949|O3|Outcome|Rizatriptan 10 mg / Rizatriptan 10 mg|Rizatriptan 10 mg initially, prerandomized to rizatriptan 10 mg
565441|NCT00897949|O2|Outcome|Rizatriptan 5 mg / Placebo|Rizatriptan 5 mg initially, prerandomized to placebo
565442|NCT00897949|O1|Outcome|Rizatriptan 5 mg / Rizatriptan 5 mg|Rizatriptan 5 mg initially, prerandomized to rizatriptan 5 mg
565443|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
565444|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
565445|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565446|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
565447|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
565448|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565449|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
565450|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
565451|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565452|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
565453|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
565454|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565455|NCT00897949|E3|Reported Event|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
565456|NCT00897949|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
565457|NCT00897949|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
565458|NCT00891436|B3|Baseline|Total|Total of all reporting groups
565459|NCT00891436|B2|Baseline|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
565460|NCT00891436|B1|Baseline|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
565461|NCT00891436|P2|Participant Flow|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
565462|NCT00891436|P1|Participant Flow|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
565463|NCT00891436|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
565464|NCT00891436|O1|Outcome|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
565465|NCT00891436|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
565466|NCT00891436|O1|Outcome|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
565467|NCT00891436|E2|Reported Event|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
565468|NCT00891436|E1|Reported Event|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
565469|NCT00891462|B4|Baseline|Total|Total of all reporting groups
565470|NCT00891462|B3|Baseline|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
565471|NCT00891462|B2|Baseline|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
565472|NCT00891462|B1|Baseline|Placebo|Inhaled placebo for 12 weeks
565473|NCT00891462|P3|Participant Flow|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
565474|NCT00891462|P2|Participant Flow|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
565475|NCT00891462|P1|Participant Flow|Placebo|Inhaled placebo for 12 weeks
565476|NCT00891462|O3|Outcome|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
565477|NCT00891462|O2|Outcome|Aclidinium Bromide, 200 µg|Aclidinium bromide, 200 µg dose, Oral inhalation, twice per day, for 12 weeks of treatment
565478|NCT00891462|O1|Outcome|Placebo|Dose matched placebo twice per day, inhaled for 12 weeks of treatment
565479|NCT00891462|O3|Outcome|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
565480|NCT00891462|O2|Outcome|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
565481|NCT00891462|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment
565482|NCT00891462|E3|Reported Event|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
565483|NCT00891462|E2|Reported Event|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
565484|NCT00891462|E1|Reported Event|Placebo|Inhaled placebo for 12 weeks
565485|NCT00891527|B1|Baseline|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
565935|NCT00900627|B6|Baseline|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565486|NCT00891527|P1|Participant Flow|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
565487|NCT00891527|O1|Outcome|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease, significant lung disease, and those who progressed were also treated with Avastin (bevacizumab).
565488|NCT00891527|O1|Outcome|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
565489|NCT00891527|O1|Outcome|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease, significant lung disease, and those who progressed were also treated with Avastin (bevacizumab).
565490|NCT00891527|E1|Reported Event|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
565491|NCT00891618|B1|Baseline|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
565492|NCT00891618|P1|Participant Flow|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
565493|NCT00891618|O1|Outcome|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
565494|NCT00891618|E1|Reported Event|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
565495|NCT00891657|B3|Baseline|Total|Total of all reporting groups
565496|NCT00891657|B2|Baseline|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
565497|NCT00891657|B1|Baseline|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
565498|NCT00891657|P2|Participant Flow|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
565499|NCT00891657|P1|Participant Flow|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
565500|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
565501|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
565502|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
565503|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
565504|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
565505|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
565506|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
565507|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
565508|NCT00891657|E2|Reported Event|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
565509|NCT00891657|E1|Reported Event|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
565510|NCT00891735|B5|Baseline|Total|Total of all reporting groups
565511|NCT00891735|B4|Baseline|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
565512|NCT00891735|B3|Baseline|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
565513|NCT00891735|B2|Baseline|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
565514|NCT00891735|B1|Baseline|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
565615|NCT00899392|E1|Reported Event|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
565515|NCT00891735|P4|Participant Flow|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
565516|NCT00891735|P3|Participant Flow|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
565517|NCT00891735|P2|Participant Flow|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
565518|NCT00891735|P1|Participant Flow|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
565519|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
565520|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
565521|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
565522|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
565523|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
565524|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
565525|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
565526|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
565527|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
565528|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
565529|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
565530|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
565531|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
565532|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
565533|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
565534|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
565535|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
565536|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
565537|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
565538|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
565539|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
565574|NCT00899353|O5|Outcome|Nuclear Factor Kappa B Activation Post Supplement|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following discontinued consumption of omega 3.
565920|NCT00900159|O1|Outcome|Eszopiclone|Medication for insomnia symptoms
565540|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
565541|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
565542|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
565543|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
565544|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
565545|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
565546|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
565547|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
565548|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
565549|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
565550|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
565551|NCT00891735|E4|Reported Event|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
565552|NCT00891735|E3|Reported Event|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
565553|NCT00891735|E2|Reported Event|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
565554|NCT00891735|E1|Reported Event|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
565555|NCT00898222|B1|Baseline|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks
aspirin : 81 mg orally daily for two weeks"
565556|NCT00898222|P1|Participant Flow|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks
aspirin : 81 mg orally daily for two weeks"
565557|NCT00898222|O1|Outcome|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks
aspirin : 81 mg orally daily for two weeks"
565558|NCT00898222|E1|Reported Event|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks
aspirin : 81 mg orally daily for two weeks"
565559|NCT00899353|B1|Baseline|Omega 3 Supplementation|
565560|NCT00899353|P1|Participant Flow|Omega 3 Supplementation|Baseline blood specimens were obtained. All participants were then assigned to consume three, 1250mg omega 3 supplement capsules per day (providing 2.4g of omega 3 total) for one month, the first period. Blood was obtained and participants were assigned to consume six, 1250mg capsules of omega 3 per day (providing 4.8g of omega 3)for one month, the second period. Blood was again obtained and participants were assigned to consume 9 capsules of omega 3 per day, providing 7.2g of omega 3,the third period.
565561|NCT00899353|O13|Outcome|Fold Change in ALC-Patient 14|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565562|NCT00899353|O12|Outcome|Fold Change in ALC-Patient 13|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565563|NCT00899353|O11|Outcome|Fold Change in ALC-Patient 11|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565564|NCT00899353|O10|Outcome|Fold Change in ALC-Patient 10|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565565|NCT00899353|O9|Outcome|Fold Change in ALC-Patient 9|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565566|NCT00899353|O8|Outcome|Fold Change in ALC-Patient 8|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565567|NCT00899353|O7|Outcome|Fold Change in ALC-Patient 7|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565568|NCT00899353|O6|Outcome|Fold Change in ALC-Patient 6|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565569|NCT00899353|O5|Outcome|Fold Change in ALC-Patient 5|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565570|NCT00899353|O4|Outcome|Fold Change in ALC-Patient 4|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565571|NCT00899353|O3|Outcome|Fold Change in ALC-Patient 3|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565572|NCT00899353|O2|Outcome|Fold Change in ALC-Patient 2|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565573|NCT00899353|O1|Outcome|Fold Change in ALC-Patient 1|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
565614|NCT00899392|E2|Reported Event|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
565575|NCT00899353|O4|Outcome|Nuclear Factor Kappa B Activation Following 9 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 9 capsules per day (7.2 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
565576|NCT00899353|O3|Outcome|Nuclear Factor Kappa B Activation Following 6 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 6 capsules per day (4.8 g of omega 3 per day).Each 1250mg capsule provided 800mg of omega 3.
565577|NCT00899353|O2|Outcome|Nuclear Factor Kappa B Activation Following 3 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 3 capsules per day (2.4 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
565578|NCT00899353|O1|Outcome|Baseline Nuclear Factor Kappa B Activation|Baseline nuclear factor Kappa B (NFkB) activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia.
565579|NCT00899353|E1|Reported Event|Adverse Effects|Serious adverse effects associated with omega 3 fatty acid consumption.
565580|NCT00899379|B6|Baseline|Total|Total of all reporting groups
565581|NCT00899379|B5|Baseline|Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
565582|NCT00899379|B4|Baseline|Rizatriptan/Rizatriptan/Rizatriptan/Placebo|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
565583|NCT00899379|B3|Baseline|Rizatriptan/Rizatriptan/Placebo/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
565584|NCT00899379|B2|Baseline|Rizatriptan/Placebo/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
565585|NCT00899379|B1|Baseline|Placebo/Rizatriptan/Rizatriptan/Rizatriptan|Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
565586|NCT00899379|P5|Participant Flow|Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
565587|NCT00899379|P4|Participant Flow|Rizatriptan/Rizatriptan/Rizatriptan/Placebo|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
565588|NCT00899379|P3|Participant Flow|Rizatriptan/Rizatriptan/Placebo/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
565589|NCT00899379|P2|Participant Flow|Rizatriptan/Placebo/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
565590|NCT00899379|P1|Participant Flow|Placebo/Rizatriptan/Rizatriptan/Rizatriptan|Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
565591|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
565592|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
565593|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
565594|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
565595|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
565596|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
565597|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
565598|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
565599|NCT00899379|E2|Reported Event|Placebo|All Placebo patients from all Treatment Sequences
565600|NCT00899379|E1|Reported Event|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
565601|NCT00899392|B3|Baseline|Total|Total of all reporting groups
565602|NCT00899392|B2|Baseline|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
565603|NCT00899392|B1|Baseline|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
565604|NCT00899392|P2|Participant Flow|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
565605|NCT00899392|P1|Participant Flow|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
565606|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
565607|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
565608|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
565609|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
565610|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
565611|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
565612|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
565613|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
565616|NCT00899470|B1|Baseline|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
565617|NCT00899470|P4|Participant Flow|S/M (Fed)> S+M (Fed)> S+M (Fasted)> S/M (Fasted)|Participants were randomized to receive S/M (fed) followed by S+M (fed) followed by S+M (fasted) followed by S/M (fasted)
565618|NCT00899470|P3|Participant Flow|S+M (Fed)> S/M (Fasted) >S/M (Fed)> S+M (Fasted)|Participants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted)
565619|NCT00899470|P2|Participant Flow|S/M (Fasted)> S+M (Fasted)> S+M (Fed)> S/M (Fed)|Participants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed)
565620|NCT00899470|P1|Participant Flow|S+M (Fasted)> S/M (Fed)> S/M (Fasted)>S+M (Fed)|Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M [fasted]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M [fed]) followed by S/M under fasting conditions (S/M [fasted]) followed by S + M under fed conditions (S + M [fed])
565621|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565622|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565623|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565624|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565625|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565626|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565627|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565628|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565629|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565630|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565631|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565632|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565633|NCT00899470|O5|Outcome|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
565634|NCT00899470|O4|Outcome|Saxagliptin/Metformin (Fed)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565635|NCT00899470|O3|Outcome|Co-administration of Saxagliptin and Metformin IR (Fed)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions
565636|NCT00899470|O2|Outcome|Saxagliptin/Metformin (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565637|NCT00899470|O1|Outcome|Co-administration of Saxagliptin and Metformin IR (Fasted)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565638|NCT00899470|O5|Outcome|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
565639|NCT00899470|O4|Outcome|Saxagliptin/Metformin (Fed)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565936|NCT00900627|B5|Baseline|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565640|NCT00899470|O3|Outcome|Co-administration of Saxagliptin and Metformin IR (Fed)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions
565641|NCT00899470|O2|Outcome|Saxagliptin/Metformin (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565642|NCT00899470|O1|Outcome|Co-administration of Saxagliptin and Metformin IR (Fasted)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565643|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565644|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565645|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565646|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565647|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565648|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565649|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565650|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565651|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565652|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565653|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565654|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565655|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565656|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565657|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565658|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565659|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565660|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565661|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565662|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565663|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565664|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565665|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565666|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565667|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565668|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565669|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565670|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565671|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565937|NCT00900627|B4|Baseline|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565672|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565673|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565674|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565675|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565676|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565677|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565678|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565679|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565680|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565681|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565682|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565683|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565684|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565685|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565686|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565687|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565688|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565689|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565690|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565691|NCT00899470|E4|Reported Event|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
565692|NCT00899470|E3|Reported Event|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
565693|NCT00899470|E2|Reported Event|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
565694|NCT00899470|E1|Reported Event|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
565695|NCT00899574|B1|Baseline|Imiquimod|"Each treatment cycle consists of 8 weeks.
Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.
Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
565696|NCT00899574|P1|Participant Flow|Imiquimod|"Each treatment cycle consists of 8 weeks.
Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.
Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
565697|NCT00899574|O1|Outcome|Imiquimod|"Each treatment cycle consists of 8 weeks.
Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.
Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
565698|NCT00899574|O1|Outcome|Imiquimod|"Each treatment cycle consists of 8 weeks.
Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.
Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
565921|NCT00900159|E2|Reported Event|Placebo|"eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
placebo: matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)"
565922|NCT00900159|E1|Reported Event|Eszopiclone|eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
565699|NCT00899574|E1|Reported Event|Imiquimod|"Each treatment cycle consists of 8 weeks.
Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.
Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
565700|NCT00899600|B3|Baseline|Total|Total of all reporting groups
565701|NCT00899600|B2|Baseline|Ketamine|
565702|NCT00899600|B1|Baseline|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
565703|NCT00899600|P2|Participant Flow|Ketamine|
565704|NCT00899600|P1|Participant Flow|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
565705|NCT00899600|O2|Outcome|Ketamine|Ketamine 0.5 mg/kg on induction and an infusion at 10mcg/kg/min until wound closure.
565706|NCT00899600|O1|Outcome|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
565707|NCT00899600|E2|Reported Event|Ketamine|
565708|NCT00899600|E1|Reported Event|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
565709|NCT00899678|B4|Baseline|Total|Total of all reporting groups
565710|NCT00899678|B3|Baseline|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565711|NCT00899678|B2|Baseline|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565712|NCT00899678|B1|Baseline|Induction Only|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
400 mg for subjects ≥ 40 kg
200 mg for subjects 20 to < 40 kg"
565713|NCT00899678|P3|Participant Flow|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565714|NCT00899678|P2|Participant Flow|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565715|NCT00899678|P1|Participant Flow|Induction Only|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
400 mg for subjects ≥ 40 kg
200 mg for subjects 20 to < 40 kg"
565716|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565717|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565718|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565719|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565720|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565721|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565722|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565723|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565724|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565725|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565726|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565727|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565728|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565729|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565730|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565731|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565732|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565733|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565734|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565735|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565736|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565737|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565738|NCT00899678|E4|Reported Event|Overall Study|Overall Study comprises Induction Period and Maintenance Period (Week -6 to Week 62).
565923|NCT00900237|B3|Baseline|Total|Total of all reporting groups
566107|NCT00894699|P2|Participant Flow|Single Dose of Placebo NanoTab™|Single dose of sublingual Placebo NanoTab™
565739|NCT00899678|E3|Reported Event|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565740|NCT00899678|E2|Reported Event|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
565741|NCT00899678|E1|Reported Event|Induction Period|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
400 mg for subjects ≥ 40 kg
200 mg for subjects 20 to < 40 kg"
565742|NCT00899717|B3|Baseline|Total|Total of all reporting groups
565743|NCT00899717|B2|Baseline|Sham Occlusal Adjustment|
565744|NCT00899717|B1|Baseline|Real Occlusal Adjustment|
565745|NCT00899717|P2|Participant Flow|Sham Occlusal Adjustment|Placebo occlusal adjustment : Simulated modification of occlusal surfaces
565746|NCT00899717|P1|Participant Flow|Real Occlusal Adjustment|Occlusal adjustment : modification of occlusal surfaces
565747|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|Placebo occlusal adjustment : Simulated modification of occlusal surfaces
565748|NCT00899717|O1|Outcome|Real Occlusal Adjustment|Occlusal adjustment : modification of occlusal surfaces
565749|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|
565750|NCT00899717|O1|Outcome|Real Occlusal Adjustment|
565751|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|Number of patients who changed their habitual chewing side
565752|NCT00899717|O1|Outcome|Real Occlusal Adjustment|Number of patients who changed their habitual chewing side
565753|NCT00899717|O2|Outcome|Placebo|
565754|NCT00899717|O1|Outcome|Real|
565755|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|
565756|NCT00899717|O1|Outcome|Real Occlusal Adjustment|
565757|NCT00899717|E2|Reported Event|Sham Occlusal Adjustment|
565758|NCT00899717|E1|Reported Event|Real Occlusal Adjustment|
565759|NCT00900029|B6|Baseline|Total|Total of all reporting groups
565760|NCT00900029|B5|Baseline|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
565761|NCT00900029|B4|Baseline|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
565762|NCT00900029|B3|Baseline|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
565763|NCT00900029|B2|Baseline|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
565764|NCT00900029|B1|Baseline|HP802-247 Vehicle|Acellular vehicle applied weekly
565765|NCT00900029|P5|Participant Flow|HP802-247 Vehicle|Acellular vehicle applied weekly applied to wound surface every week
565766|NCT00900029|P4|Participant Flow|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
565767|NCT00900029|P3|Participant Flow|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
565768|NCT00900029|P2|Participant Flow|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
565769|NCT00900029|P1|Participant Flow|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
565770|NCT00900029|O5|Outcome|HP802-247 Vehicle|Acellular vehicle applied weekly
565771|NCT00900029|O4|Outcome|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
565772|NCT00900029|O3|Outcome|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
565773|NCT00900029|O2|Outcome|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
565774|NCT00900029|O1|Outcome|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
565775|NCT00900029|O5|Outcome|HP802-247 Vehicle|Acellular vehicle applied weekly
565776|NCT00900029|O4|Outcome|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
565777|NCT00900029|O3|Outcome|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
565778|NCT00900029|O2|Outcome|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
565779|NCT00900029|O1|Outcome|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
565780|NCT00900029|E5|Reported Event|HP802-247 Vehicle|
565781|NCT00900029|E4|Reported Event|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
565782|NCT00900029|E3|Reported Event|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
565783|NCT00900029|E2|Reported Event|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
565784|NCT00900029|E1|Reported Event|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
565785|NCT00900146|B6|Baseline|Total|Total of all reporting groups
565786|NCT00900146|B5|Baseline|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565787|NCT00900146|B4|Baseline|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
566109|NCT00894699|O2|Outcome|Placebo NanoTab™|Single dose of sublingual Placebo NanoTab™
565788|NCT00900146|B3|Baseline|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565789|NCT00900146|B2|Baseline|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565790|NCT00900146|B1|Baseline|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565791|NCT00900146|P5|Participant Flow|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565792|NCT00900146|P4|Participant Flow|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565793|NCT00900146|P3|Participant Flow|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565794|NCT00900146|P2|Participant Flow|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565795|NCT00900146|P1|Participant Flow|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565796|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565797|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565938|NCT00900627|B3|Baseline|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
566171|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
565798|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565799|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565800|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565801|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565802|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565803|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565804|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565805|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565806|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565807|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565924|NCT00900237|B2|Baseline|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
565808|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565809|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565810|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565811|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565812|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565813|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565814|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565815|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565816|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565817|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565925|NCT00900237|B1|Baseline|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
565818|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565819|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565820|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565821|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565822|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565823|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565824|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565825|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565826|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565827|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565926|NCT00900237|P2|Participant Flow|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
565828|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565829|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565830|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565831|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565832|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565833|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565834|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565835|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565836|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565837|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565927|NCT00900237|P1|Participant Flow|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
565838|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565839|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565840|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565841|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565842|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565843|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565844|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565845|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565846|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565847|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565928|NCT00900237|O2|Outcome|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
565848|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565849|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565850|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565851|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565852|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565853|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565854|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565855|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565856|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565857|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565929|NCT00900237|O1|Outcome|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
565858|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565859|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565860|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565861|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565862|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565863|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565864|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565865|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565866|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565867|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565930|NCT00900237|O2|Outcome|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
565868|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565869|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565870|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565871|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565872|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565873|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565874|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565875|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565876|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565877|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565931|NCT00900237|O1|Outcome|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
565878|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565879|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565880|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565881|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565882|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565883|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565884|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565885|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565886|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565887|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565932|NCT00900237|E2|Reported Event|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
565888|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565889|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565890|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565891|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565892|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565893|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565894|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565895|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565896|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565897|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565933|NCT00900237|E1|Reported Event|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
565898|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565899|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565900|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565901|NCT00900146|E5|Reported Event|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
565902|NCT00900146|E4|Reported Event|Canakinumab 150 mg + Metformin|"Experimental: Canakinumab 150 mg + Metformin In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565903|NCT00900146|E3|Reported Event|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565904|NCT00900146|E2|Reported Event|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565905|NCT00900146|E1|Reported Event|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.
The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
565906|NCT00900159|B3|Baseline|Total|Total of all reporting groups
565907|NCT00900159|B2|Baseline|Placebo Then Eszopiclone|Study participants on placebo and then eszopiclone
565908|NCT00900159|B1|Baseline|Eszopiclone Then Placebo|Study participants on eszopiclone and then placebo
565909|NCT00900159|P2|Participant Flow|Placebo Then Eszopiclone|Study participants on placebo and then eszopiclone
565910|NCT00900159|P1|Participant Flow|Eszopiclone Then Placebo|Study participants on eszopiclone and then placebo
565911|NCT00900159|O2|Outcome|Placebo|Non-medicated pills
565912|NCT00900159|O1|Outcome|Eszopiclone|Medication for insomnia symptoms
565913|NCT00900159|O2|Outcome|Placebo|Non-medicated pills
565914|NCT00900159|O1|Outcome|Eszopiclone|Medication for insomnia symptoms
565915|NCT00900159|O2|Outcome|Placebo|Non-medicated pills
565916|NCT00900159|O1|Outcome|Eszopiclone|Medication for insomnia symptoms
565917|NCT00900159|O2|Outcome|Placebo|Non-medicated pills
565918|NCT00900159|O1|Outcome|Eszopiclone|Medication for insomnia symptoms
565919|NCT00900159|O2|Outcome|Placebo|Non-medicated pills
565939|NCT00900627|B2|Baseline|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565940|NCT00900627|B1|Baseline|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565941|NCT00900627|P6|Participant Flow|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565942|NCT00900627|P5|Participant Flow|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565943|NCT00900627|P4|Participant Flow|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565944|NCT00900627|P3|Participant Flow|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565945|NCT00900627|P2|Participant Flow|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565946|NCT00900627|P1|Participant Flow|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565947|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565948|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565949|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565950|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565951|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565952|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565953|NCT00900627|O4|Outcome|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565954|NCT00900627|O3|Outcome|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565955|NCT00900627|O2|Outcome|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565956|NCT00900627|O1|Outcome|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565957|NCT00900627|E6|Reported Event|Placebo + Paclitaxel|
565958|NCT00900627|E5|Reported Event|AZD8931 40MG bd + Paclitaxel|
565959|NCT00900627|E4|Reported Event|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565960|NCT00900627|E3|Reported Event|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
565961|NCT00900627|E2|Reported Event|AZD8931 80 mg bd|
565962|NCT00900627|E1|Reported Event|AZD8931 40 mg bd|
565963|NCT00900666|B3|Baseline|Total|Total of all reporting groups
565964|NCT00900666|B2|Baseline|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
565965|NCT00900666|B1|Baseline|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
565966|NCT00900666|P2|Participant Flow|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
565967|NCT00900666|P1|Participant Flow|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
565968|NCT00900666|O2|Outcome|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
565969|NCT00900666|O1|Outcome|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
565970|NCT00900666|O2|Outcome|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
565971|NCT00900666|O1|Outcome|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
565972|NCT00900666|E2|Reported Event|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
565973|NCT00900666|E1|Reported Event|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
565974|NCT00900731|B3|Baseline|Total|Total of all reporting groups
566108|NCT00894699|P1|Participant Flow|Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
565975|NCT00900731|B2|Baseline|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565976|NCT00900731|B1|Baseline|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565977|NCT00900731|P2|Participant Flow|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565978|NCT00900731|P1|Participant Flow|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565979|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565980|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565981|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565982|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565983|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565984|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565985|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565986|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565987|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565988|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565989|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565990|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565991|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565992|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565993|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565994|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
566042|NCT00901186|P2|Participant Flow|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
565995|NCT00900731|E2|Reported Event|Tiotropium 18 μg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565996|NCT00900731|E1|Reported Event|Indacaterol 150 μg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
565997|NCT00900757|B1|Baseline|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
565998|NCT00900757|P1|Participant Flow|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
565999|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
566000|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
566001|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
566002|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
566003|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
566004|NCT00900757|E1|Reported Event|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
566005|NCT00900796|B1|Baseline|Anti-tumor Necrosis Factor Agents (Evaluable Population)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-TNF agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, in Phase 1 of the study and who were eligible for the analysis.
566006|NCT00900796|P1|Participant Flow|Anti-tumor Necrosis Factor Agents|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator’s discretion in Phase 2 of the study.
566007|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
566008|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
566009|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
566010|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
566011|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
566012|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
566013|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
566014|NCT00900796|E1|Reported Event|Anti-tumor Necrosis Factor Agents|Participants with active AS who were prescribed with an anti-TNF agent, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator’s discretion in Phase 2 of the study.
566015|NCT00900822|B1|Baseline|Straumann Bone Ceramic|Synthetic bone graft material
566016|NCT00900822|P1|Participant Flow|Straumann BoneCeramic|Synthetic bone graft material
566017|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
566018|NCT00900822|O1|Outcome|Straumann Bone Ceramic|Synthetic bone graft material
566019|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
566020|NCT00900822|O1|Outcome|Straumann BoneCeramic|Synthetic bone graft material
566021|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
566022|NCT00900822|O1|Outcome|Straumann Bone Ceramic|Synthetic bone graft material
566023|NCT00900822|E2|Reported Event|BioOss|Xenograft bone graft material
566024|NCT00900822|E1|Reported Event|Straumann Bone Ceramic|Synthetic bone graft material
566025|NCT00901017|B1|Baseline|Straumann BoneCeramic and Geistlich Bio-Oss|Each patient received both treatments in a split-mouth design.
566026|NCT00901017|P1|Participant Flow|Straumann BoneCeramic and Geistlich Bio-Oss|Each patient received both treatments in a split-mouth design.
566027|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
566028|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
566029|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
566030|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
566031|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
566032|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
566033|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
566034|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
566035|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
566036|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
566037|NCT00901017|E2|Reported Event|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
566038|NCT00901017|E1|Reported Event|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
566039|NCT00901186|B3|Baseline|Total|Total of all reporting groups
566040|NCT00901186|B2|Baseline|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
566041|NCT00901186|B1|Baseline|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
566102|NCT00894647|E2|Reported Event|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
566043|NCT00901186|P1|Participant Flow|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
566044|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
566045|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
566046|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
566047|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
566048|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
566049|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
566050|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
566051|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
566052|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
566053|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
566054|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
566055|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
566056|NCT00901186|E2|Reported Event|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
566057|NCT00901186|E1|Reported Event|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
566058|NCT00901225|B1|Baseline|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
566059|NCT00901225|P1|Participant Flow|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
566060|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
566061|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
566062|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
566063|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
566064|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
566065|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
566066|NCT00901225|E1|Reported Event|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
566067|NCT00901316|B3|Baseline|Total|Total of all reporting groups
566068|NCT00901316|B2|Baseline|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
566069|NCT00901316|B1|Baseline|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
566103|NCT00894647|E1|Reported Event|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
566104|NCT00894699|B3|Baseline|Total|Total of all reporting groups
566105|NCT00894699|B2|Baseline|Placebo|Single dose of Placebo
566106|NCT00894699|B1|Baseline|Sufentanil/Triazolam NanoTab™|Single dose of sublingual Sufentanil/Triazolam 15/200 mcg NanoTab™
566172|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566070|NCT00901316|P2|Participant Flow|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
566071|NCT00901316|P1|Participant Flow|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
566072|NCT00901316|O2|Outcome|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
566073|NCT00901316|O1|Outcome|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
566074|NCT00901316|E2|Reported Event|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
566075|NCT00901316|E1|Reported Event|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
566076|NCT00901342|B1|Baseline|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
566077|NCT00901342|P1|Participant Flow|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
566078|NCT00901342|O1|Outcome|Sipuleucel-T|All subjects who received ≥ one sipuleucel-T infusion
566079|NCT00901342|E1|Reported Event|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
566080|NCT00901459|B1|Baseline|All Study Participants|"Active:
rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus
Location Control:
rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex
Frequency Control:
rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus"
566081|NCT00901459|P1|Participant Flow|All Study Participants|"Active:
rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus
Location Control:
rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex
Frequency Control:
rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus"
566082|NCT00901459|O3|Outcome|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
566083|NCT00901459|O2|Outcome|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
566084|NCT00901459|O1|Outcome|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Superior Frontal Gyrus
566085|NCT00901459|O3|Outcome|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTMS Location: Superior Frontal Gyrus
566086|NCT00901459|O2|Outcome|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex
566087|NCT00901459|O1|Outcome|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus
566088|NCT00901459|E3|Reported Event|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
566089|NCT00901459|E2|Reported Event|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
566090|NCT00901459|E1|Reported Event|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Superior Frontal Gyrus
566091|NCT00894647|B3|Baseline|Total|Total of all reporting groups
566092|NCT00894647|B2|Baseline|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
566093|NCT00894647|B1|Baseline|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
566094|NCT00894647|P2|Participant Flow|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
566095|NCT00894647|P1|Participant Flow|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
566096|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
566097|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
566098|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
566099|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
566100|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
566101|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
566110|NCT00894699|O1|Outcome|Sublingual Sufentanil 15 mcg/Triazolam NanoTab™ 200 mcg|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
566111|NCT00894699|E2|Reported Event|Placebo|Single dose of Placebo
566112|NCT00894699|E1|Reported Event|Sufentanil/Triazolam NanoTab™|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
566113|NCT00894790|B3|Baseline|Total|Total of all reporting groups
566114|NCT00894790|B2|Baseline|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566115|NCT00894790|B1|Baseline|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566116|NCT00894790|P2|Participant Flow|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566117|NCT00894790|P1|Participant Flow|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566118|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566119|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566120|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566121|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566122|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566123|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566124|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566125|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566126|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566127|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566128|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566129|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566130|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566131|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566132|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566133|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566134|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566135|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566136|NCT00894790|E2|Reported Event|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
566137|NCT00894790|E1|Reported Event|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
566138|NCT00894803|B3|Baseline|Total|Total of all reporting groups
566139|NCT00894803|B2|Baseline|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566140|NCT00894803|B1|Baseline|Rt-PA Only|rt-PA (0.9 mg/kg)
566141|NCT00894803|P2|Participant Flow|Rt-PA Only|recombinant tissue Plasminogen Activator (rt-PA; 0.9 mg/kg)
566142|NCT00894803|P1|Participant Flow|Rt-PA and Eptifibatide|recombinant tissue Plasminogen Activator (rt-PA; 0.6 mg/kg) and Epifibatide (225 mcg/kg)
566143|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566144|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566145|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566146|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566147|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566148|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566149|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566150|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566151|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566152|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566153|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566154|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566155|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566156|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566157|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566158|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566159|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566160|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566161|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566162|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566163|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566164|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566165|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566166|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566167|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566168|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566169|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566170|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
566173|NCT00894803|E2|Reported Event|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
566174|NCT00894803|E1|Reported Event|Rt-PA Only|rt-PA (0.9 mg/kg)
566175|NCT00894933|B1|Baseline|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566176|NCT00894933|P1|Participant Flow|Continuum|"Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique.
CONTINUUM™: Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy."
566177|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566178|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566179|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566180|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566181|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566182|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566183|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566184|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566185|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566186|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566187|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566188|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566189|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566190|NCT00894933|E1|Reported Event|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
566191|NCT00895011|B4|Baseline|Total|Total of all reporting groups
566192|NCT00895011|B3|Baseline|Avanafil 200 mg|
566193|NCT00895011|B2|Baseline|Avanafil 100 mg|
566194|NCT00895011|B1|Baseline|Placebo|
566195|NCT00895011|P3|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
566196|NCT00895011|P2|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
566197|NCT00895011|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
566198|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
566199|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
566200|NCT00895011|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
566201|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
566202|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
566203|NCT00895011|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
566204|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
566205|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
566206|NCT00895011|O1|Outcome|Placebo|placeb 30 minutes orally prior to initiation of sexual activity
566207|NCT00895011|E3|Reported Event|Avanafil 200 mg|
566208|NCT00895011|E2|Reported Event|Avanafil 100 mg|
566209|NCT00895011|E1|Reported Event|Placebo|
566210|NCT00895180|B3|Baseline|Total|Total of all reporting groups
566211|NCT00895180|B2|Baseline|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566212|NCT00895180|B1|Baseline|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566213|NCT00895180|P2|Participant Flow|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566214|NCT00895180|P1|Participant Flow|Group 1 Ramucirumab|Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566215|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566216|NCT00895180|O1|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566217|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566218|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
572641|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
566219|NCT00895180|O1|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566220|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566221|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566222|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566223|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566224|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566225|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566226|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566227|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566228|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566229|NCT00895180|E2|Reported Event|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566230|NCT00895180|E1|Reported Event|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
566231|NCT00895193|B5|Baseline|Total|Total of all reporting groups
566232|NCT00895193|B4|Baseline|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566233|NCT00895193|B3|Baseline|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566234|NCT00895193|B2|Baseline|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566235|NCT00895193|B1|Baseline|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566236|NCT00895193|P4|Participant Flow|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566237|NCT00895193|P3|Participant Flow|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566238|NCT00895193|P2|Participant Flow|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566239|NCT00895193|P1|Participant Flow|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566240|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566241|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566242|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566243|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566244|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566245|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566246|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566247|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566248|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566249|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566250|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566251|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566252|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566253|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566254|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566255|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566256|NCT00895193|E4|Reported Event|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566257|NCT00895193|E3|Reported Event|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566258|NCT00895193|E2|Reported Event|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566259|NCT00895193|E1|Reported Event|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
566260|NCT00895232|B4|Baseline|Total|Total of all reporting groups
566261|NCT00895232|B3|Baseline|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
566262|NCT00895232|B2|Baseline|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
566263|NCT00895232|B1|Baseline|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
566264|NCT00895232|P3|Participant Flow|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
566265|NCT00895232|P2|Participant Flow|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
566266|NCT00895232|P1|Participant Flow|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
566267|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
566268|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
566269|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
566270|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
566271|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
566272|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
566273|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
566274|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
566275|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
566276|NCT00895232|E3|Reported Event|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
566277|NCT00895232|E2|Reported Event|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
566278|NCT00895232|E1|Reported Event|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
566279|NCT00895245|B1|Baseline|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.
Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.
Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.
fosaprepitant dimeglumine: Given IV
cisplatin: Given IV
palonosetron hydrochloride: Given IV
dexamethasone: Given IV and orally
Functional Living Index-Emesis Questionnaire: Ancillary studies
Emesis Diary: Ancillary studies
Radiotherapy: Undergo radiotherapy"
566280|NCT00895245|P1|Participant Flow|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.
Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.
Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.
fosaprepitant dimeglumine: Given IV
cisplatin: Given IV
palonosetron hydrochloride: Given IV
dexamethasone: Given IV and orally
Functional Living Index-Emesis Questionnaire: Ancillary studies
Emesis Diary: Ancillary studies
Radiotherapy: Undergo radiotherapy"
566281|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.
Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.
Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.
fosaprepitant dimeglumine: Given IV
cisplatin: Given IV
palonosetron hydrochloride: Given IV
dexamethasone: Given IV and orally
Functional Living Index-Emesis Questionnaire: Ancillary studies
Emesis Diary: Ancillary studies
Radiotherapy: Undergo r"
566307|NCT00901576|B2|Baseline|SPD503 First, Then SPD503 + Concerta, Then Concerta|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
566308|NCT00901576|B1|Baseline|SPD503 First, Then Concerta, Then SPD503 + Concerta|SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
566407|NCT00903175|P1|Participant Flow|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566282|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.
Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.
Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.
fosaprepitant dimeglumine: Given IV
cisplatin: Given IV
palonosetron hydrochloride: Given IV
dexamethasone: Given IV and orally
Functional Living Index-Emesis Questionnaire: Ancillary studies
Emesis Diary: Ancillary studies
Radiotherapy: Undergo r"
566283|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.
Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.
Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.
fosaprepitant dimeglumine: Given IV
cisplatin: Given IV
palonosetron hydrochloride: Given IV
dexamethasone: Given IV and orally
Functional Living Index-Emesis Questionnaire: Ancillary studies
Emesis Diary: Ancillary studies
Radiotherapy: Undergo r"
566284|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.
Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.
Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.
fosaprepitant dimeglumine: Given IV
cisplatin: Given IV
palonosetron hydrochloride: Given IV
dexamethasone: Given IV and orally
Functional Living Index-Emesis Questionnaire: Ancillary studies
Emesis Diary: Ancillary studies
Radiotherapy: Undergo r"
566285|NCT00895245|E1|Reported Event|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.
Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.
Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.
fosaprepitant dimeglumine: Given IV
cisplatin: Given IV
palonosetron hydrochloride: Given IV
dexamethasone: Given IV and orally
Functional Living Index-Emesis Questionnaire: Ancillary studies
Emesis Diary: Ancillary studies
Radiotherapy: Undergo r"
566286|NCT00895284|B3|Baseline|Total|Total of all reporting groups
566287|NCT00895284|B2|Baseline|Standard|Standard hysterectomy
566288|NCT00895284|B1|Baseline|Robot|Robotic hysterectomy
566289|NCT00895284|P2|Participant Flow|Standard|Standard hysterectomy
566290|NCT00895284|P1|Participant Flow|Robot|Robotic hysterectomy
566291|NCT00895284|O2|Outcome|Standard|Standard hysterectomy
566292|NCT00895284|O1|Outcome|Robot|Robotic hysterectomy
566293|NCT00895284|E2|Reported Event|Standard|Standard hysterectomy
566294|NCT00895284|E1|Reported Event|Robot|Robotic hysterectomy
566295|NCT00895310|B1|Baseline|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm
Ketoconazole: Ketoconazole is taken three times a day by mouth."
566296|NCT00895310|P1|Participant Flow|Ketoconazole|"Ketoconazole 200mg PO (by mouth) TID (three times a day) + Hydrocortisone 20mg PO Qam (every morning), 10mg PO Qpm (every evening)
Ketoconazole: Ketoconazole is taken three times a day by mouth."
566297|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm
Ketoconazole: Ketoconazole is taken three times a day by mouth."
566298|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm
Ketoconazole: Ketoconazole is taken three times a day by mouth."
566299|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm
Ketoconazole: Ketoconazole is taken three times a day by mouth."
566300|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm
Ketoconazole: Ketoconazole is taken three times a day by mouth."
566301|NCT00895310|E1|Reported Event|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm
Ketoconazole: Ketoconazole is taken three times a day by mouth."
566302|NCT00901576|B7|Baseline|Total|Total of all reporting groups
566303|NCT00901576|B6|Baseline|SPD503 + Concerta First, Then Concerta, Then SPD503|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
566304|NCT00901576|B5|Baseline|SPD503 + Concerta First, Then SPD503, Then Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
566305|NCT00901576|B4|Baseline|Concerta First, Then SPD503 + Concerta, Then SPD503|Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
566306|NCT00901576|B3|Baseline|Concerta First, Then SPD503, Then SPD503 + Concerta|Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
566438|NCT00903331|B1|Baseline|Placebo|"Matching placebo, once daily
Placebo : matching placebo, once daily"
567032|NCT00905255|O2|Outcome|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
566309|NCT00901576|P6|Participant Flow|SPD503 + Concerta First, Then Concerta, Then SPD503|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
566310|NCT00901576|P5|Participant Flow|SPD503 + Concerta First, Then SPD503, Then Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
566311|NCT00901576|P4|Participant Flow|Concerta First, Then SPD503 + Concerta, Then SPD503|Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
566312|NCT00901576|P3|Participant Flow|Concerta First, Then SPD503, Then SPD503 + Concerta|Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
566313|NCT00901576|P2|Participant Flow|SPD503 First, Then SPD503 + Concerta, Then Concerta|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
566314|NCT00901576|P1|Participant Flow|SPD503 First, Then Concerta, Then SPD503 + Concerta|SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
566315|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
566316|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
566317|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
566318|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
566319|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
566320|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
566321|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
566322|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
566323|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
566324|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
566325|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
566326|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
566327|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
566328|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
566329|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
566330|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
566331|NCT00901576|E3|Reported Event|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
566332|NCT00901576|E2|Reported Event|Concerta Alone|Single 36 mg dose of extended-release methylphenidate HCl
566333|NCT00901576|E1|Reported Event|SPD503 Alone|Single 4 mg dose of extended-release guanfacine HCl
566334|NCT00901628|B3|Baseline|Total|Total of all reporting groups
566335|NCT00901628|B2|Baseline|No Injection Group|usual postoperative care without periarticular injection
566336|NCT00901628|B1|Baseline|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
566337|NCT00901628|P2|Participant Flow|No Injection Group|usual postoperative care using the continuous femoral nerve block, IV-PCA and preemptive oral medications without periarticular injection
566338|NCT00901628|P1|Participant Flow|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
566339|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
566340|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
566341|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
566342|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
566343|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
566344|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
566345|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
566346|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
566347|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
566348|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
566349|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
566350|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
566351|NCT00901628|E2|Reported Event|No Injection Group|usual postoperative care without periarticular injection
566352|NCT00901628|E1|Reported Event|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
566353|NCT00902668|B1|Baseline|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
566354|NCT00902668|P1|Participant Flow|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
566355|NCT00902668|O1|Outcome|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
566356|NCT00902668|E1|Reported Event|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
566357|NCT00902746|B1|Baseline|NPC-01|"Norethisterone, Ethinyl Estradiol
NPC-01: This study consist of the following steps.
Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.
Step 2(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg, or Norethisterone 1mg, Ethinyl Estradiol 0.035mg):
After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
566358|NCT00902746|P1|Participant Flow|NPC-01|"Norethisterone, Ethinyl Estradiol
NPC-01: This study consist of the following steps.
Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.
Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):
After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
566359|NCT00902746|O1|Outcome|NPC-01|"Norethisterone, Ethinyl Estradiol
NPC-01: This study consist of the following steps.
Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.
Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):
After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
566360|NCT00902746|O1|Outcome|NPC-01|"Norethisterone, Ethinyl Estradiol
NPC-01: This study consist of the following steps.
Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.
Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):
After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
566361|NCT00902746|E1|Reported Event|NPC-01|"Norethisterone, Ethinyl Estradiol
NPC-01: This study consist of the following steps.
Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.
Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):
After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
566362|NCT00902850|B3|Baseline|Total|Total of all reporting groups
566363|NCT00902850|B2|Baseline|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens
Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
566364|NCT00902850|B1|Baseline|SofLens Daily Disposable|"SofLens Daily Disposable Lenses
SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
566365|NCT00902850|P2|Participant Flow|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens
Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
566366|NCT00902850|P1|Participant Flow|SofLens Daily Disposable|"SofLens Daily Disposable Lenses
SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
566367|NCT00902850|O2|Outcome|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens
Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
566368|NCT00902850|O1|Outcome|SofLens Daily Disposable|"SofLens Daily Disposable Lenses
SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
566369|NCT00902850|E2|Reported Event|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens
Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
566370|NCT00902850|E1|Reported Event|SofLens Daily Disposable|"SofLens Daily Disposable Lenses
SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
566371|NCT00903006|B5|Baseline|Total|Total of all reporting groups
566372|NCT00903006|B4|Baseline|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
566373|NCT00903006|B3|Baseline|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
566406|NCT00903175|P2|Participant Flow|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
567033|NCT00905255|O1|Outcome|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
566374|NCT00903006|B2|Baseline|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
566375|NCT00903006|B1|Baseline|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
566376|NCT00903006|P4|Participant Flow|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
566377|NCT00903006|P3|Participant Flow|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
566378|NCT00903006|P2|Participant Flow|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
566379|NCT00903006|P1|Participant Flow|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
566380|NCT00903006|O4|Outcome|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
566381|NCT00903006|O3|Outcome|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
566382|NCT00903006|O2|Outcome|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
566383|NCT00903006|O1|Outcome|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
566384|NCT00903006|E4|Reported Event|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
566385|NCT00903006|E3|Reported Event|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
566386|NCT00903006|E2|Reported Event|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
566387|NCT00903006|E1|Reported Event|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.
Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
566388|NCT00903032|B3|Baseline|Total|Total of all reporting groups
566389|NCT00903032|B2|Baseline|Usual Care|"Patients will receive usual care following ACS hospital discharge
Usual care: Usual care following ACS hospital discharge."
566390|NCT00903032|B1|Baseline|Patient Centered Intervention|The multi-faceted patient centered intervention adapts elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, PCPs, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs. Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
566391|NCT00903032|P2|Participant Flow|Usual Care|"Patients will receive usual care following ACS hospital discharge
Usual care: Usual care following ACS hospital discharge."
566439|NCT00903331|P2|Participant Flow|ACT-064922|"ACT-064922 tablet, 10 mg, once daily
ACT-064992 (macitentan) : tablet, 10 mg, once daily"
567105|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
566392|NCT00903032|P1|Participant Flow|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of re"
566393|NCT00903032|O2|Outcome|Usual Care|"Patients will receive usual care following ACS hospital discharge
Usual care: Usual care following ACS hospital discharge."
566394|NCT00903032|O1|Outcome|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs."
566395|NCT00903032|E2|Reported Event|Usual Care|"Patients will receive usual care following ACS hospital discharge
Usual care: Usual care following ACS hospital discharge."
566396|NCT00903032|E1|Reported Event|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education, tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs."
566397|NCT00903162|B1|Baseline|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.
leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years
letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration
zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
566398|NCT00903162|P1|Participant Flow|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.
leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years
letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration
zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
566399|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.
leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years
letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration
zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
566400|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.
leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years
letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration
zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
566401|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.
leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years
letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration
zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
566402|NCT00903162|E1|Reported Event|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.
leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years
letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration
zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
566403|NCT00903175|B3|Baseline|Total|Total of all reporting groups
566404|NCT00903175|B2|Baseline|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566405|NCT00903175|B1|Baseline|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566440|NCT00903331|P1|Participant Flow|Placebo|"Matching placebo, once daily
Placebo : matching placebo, once daily"
566408|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566409|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566410|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566411|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566412|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566413|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566414|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566415|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566416|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566417|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566418|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566419|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566420|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566421|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566422|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566423|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566424|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566425|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566426|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566427|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566428|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566429|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566430|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566431|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566432|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566433|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566434|NCT00903175|E2|Reported Event|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
566435|NCT00903175|E1|Reported Event|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
566436|NCT00903331|B3|Baseline|Total|Total of all reporting groups
566437|NCT00903331|B2|Baseline|ACT-064922|"ACT-064922 tablet, 10 mg, once daily
ACT-064992 (macitentan) : tablet, 10 mg, once daily"
566441|NCT00903331|O2|Outcome|ACT-064922|"ACT-064922 tablet, 10 mg, once daily
ACT-064992 (macitentan) : tablet, 10 mg, once daily"
566442|NCT00903331|O1|Outcome|Placebo|"Matching placebo, once daily
Placebo : matching placebo, once daily"
566443|NCT00903331|O2|Outcome|ACT-064922|"ACT-064922 tablet, 10 mg, once daily
ACT-064992 (macitentan) : tablet, 10 mg, once daily"
566444|NCT00903331|O1|Outcome|Placebo|"Matching placebo, once daily
Placebo : matching placebo, once daily"
566445|NCT00903331|E2|Reported Event|ACT-064922|"ACT-064922 tablet, 10 mg, once daily
ACT-064992 (macitentan) : tablet, 10 mg, once daily"
566446|NCT00903331|E1|Reported Event|Placebo|"Matching placebo, once daily
Placebo : matching placebo, once daily"
566447|NCT00903344|B3|Baseline|Total|Total of all reporting groups
566448|NCT00903344|B2|Baseline|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet
Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
566449|NCT00903344|B1|Baseline|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin
Vitamin D3: 4000IU vitamin D3 tablet taken daily"
566450|NCT00903344|P2|Participant Flow|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet
Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
566451|NCT00903344|P1|Participant Flow|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin
Vitamin D3: 4000IU vitamin D3 tablet taken daily"
566452|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet
Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
566453|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin
Vitamin D3: 4000IU vitamin D3 tablet taken daily"
566454|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet
Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
566455|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin
Vitamin D3: 4000IU vitamin D3 tablet taken daily"
566456|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet
Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
566457|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin
Vitamin D3: 4000IU vitamin D3 tablet taken daily"
566458|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet
Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
566459|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin
Vitamin D3: 4000IU vitamin D3 tablet taken daily"
566460|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet
Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
566461|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin
Vitamin D3: 4000IU vitamin D3 tablet taken daily"
566462|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet
Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
566463|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin
Vitamin D3: 4000IU vitamin D3 tablet taken daily"
566464|NCT00903344|E2|Reported Event|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet
Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
566465|NCT00903344|E1|Reported Event|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin
Vitamin D3: 4000IU vitamin D3 tablet taken daily"
566466|NCT00903357|B1|Baseline|Entire Study Population|Includes groups randomized to receive Montelukast first and placebo first.
566467|NCT00903357|P2|Participant Flow|Placebo First, Then Montelukast|Placebo(chewable ascorbic acid) once daily in first intervention period and Montelukast(4mg or 5mg) once daily in second intervention period (after washout period).
566468|NCT00903357|P1|Participant Flow|Montelukast First, Then Placebo|Montelukast(4mg or 5mg) once daily in first intervention period and placebo(chewable ascorbic acid) once daily in second intervention period (after washout period).
566469|NCT00903357|O2|Outcome|Placebo Drug|Changes of Urine EDN after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary EDN before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
566470|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of Urine EDN after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary EDN before and after taking Montelukast sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
566471|NCT00903357|O2|Outcome|Placebo Drug|Changes of Urine LTE4 after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary LTE4 before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
566472|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of Urine LTE4 after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary LTE4 before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
566539|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.
placebo: Given IV"
566540|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.
palonosetron hydrochloride: Given IV"
566541|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.
palonosetron hydrochloride: Given IV"
567273|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
566473|NCT00903357|O2|Outcome|Placebo Drug|Changes of SCORAD index after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
566474|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of SCORAD index after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
566475|NCT00903357|E2|Reported Event|Placebo Drug|Placebo drug administered once daily in either first intervention period or second intervention period.
566476|NCT00903357|E1|Reported Event|Montelukast Sodium|Montelukast sodium(4mg or 5mg) administered once daily in either first intervention period or second intervention period.
566477|NCT00903370|B3|Baseline|Total|Total of all reporting groups
566478|NCT00903370|B2|Baseline|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.
MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.
For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
566479|NCT00903370|B1|Baseline|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.
MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
566480|NCT00903370|P2|Participant Flow|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.
MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.
For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
566481|NCT00903370|P1|Participant Flow|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.
MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
566482|NCT00903370|O2|Outcome|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.
MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.
For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
566483|NCT00903370|O1|Outcome|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.
MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
566484|NCT00903370|O2|Outcome|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.
MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.
For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
566485|NCT00903370|O1|Outcome|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.
MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
566542|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.
placebo: Given IV"
566543|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.
placebo: Given IV"
567274|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
566486|NCT00903370|E2|Reported Event|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.
MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.
For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
566487|NCT00903370|E1|Reported Event|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.
MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
566488|NCT00903383|B5|Baseline|Total|Total of all reporting groups
566489|NCT00903383|B4|Baseline|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
566490|NCT00903383|B3|Baseline|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
566491|NCT00903383|B2|Baseline|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
566492|NCT00903383|B1|Baseline|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
566493|NCT00903383|P4|Participant Flow|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
566494|NCT00903383|P3|Participant Flow|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
566495|NCT00903383|P2|Participant Flow|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
566496|NCT00903383|P1|Participant Flow|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
566497|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
566498|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
566499|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
566500|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
566501|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
566502|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
566503|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
566504|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
566505|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
566506|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
566507|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
566508|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
566509|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
566510|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
566511|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
566512|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
566513|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
566514|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
566515|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
566516|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
566517|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
566518|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
566519|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
566520|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
566521|NCT00903383|E4|Reported Event|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
566522|NCT00903383|E3|Reported Event|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
566523|NCT00903383|E2|Reported Event|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
566524|NCT00903383|E1|Reported Event|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
566525|NCT00903396|B5|Baseline|Total|Total of all reporting groups
566526|NCT00903396|B4|Baseline|Arm IV|"Patients receive placebo IV on days 1 and 4.
placebo: Given IV"
566527|NCT00903396|B3|Baseline|Arm III|"Patients receive placebo IV on day 1.
placebo: Given IV"
566528|NCT00903396|B2|Baseline|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.
palonosetron hydrochloride: Given IV"
566529|NCT00903396|B1|Baseline|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.
palonosetron hydrochloride: Given IV"
566530|NCT00903396|P4|Participant Flow|Arm IV|"Patients receive placebo IV on days 1 and 4.
placebo: Given IV"
566531|NCT00903396|P3|Participant Flow|Arm III|"Patients receive placebo IV on day 1.
placebo: Given IV"
566532|NCT00903396|P2|Participant Flow|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.
palonosetron hydrochloride: Given IV"
566533|NCT00903396|P1|Participant Flow|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.
palonosetron hydrochloride: Given IV"
566534|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.
placebo: Given IV"
566535|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.
placebo: Given IV"
566536|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.
palonosetron hydrochloride: Given IV"
566537|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.
palonosetron hydrochloride: Given IV"
566538|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.
placebo: Given IV"
566544|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.
palonosetron hydrochloride: Given IV"
566545|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.
palonosetron hydrochloride: Given IV"
566546|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.
placebo: Given IV"
566547|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.
placebo: Given IV"
566548|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.
palonosetron hydrochloride: Given IV"
566549|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.
palonosetron hydrochloride: Given IV"
566550|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.
placebo: Given IV"
566551|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.
placebo: Given IV"
566552|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.
palonosetron hydrochloride: Given IV"
566553|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.
palonosetron hydrochloride: Given IV"
566554|NCT00903396|E4|Reported Event|Arm IV|"Patients receive placebo IV on days 1 and 4.
placebo: Given IV"
566555|NCT00903396|E3|Reported Event|Arm III|"Patients receive placebo IV on day 1.
placebo: Given IV"
566556|NCT00903396|E2|Reported Event|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.
palonosetron hydrochloride: Given IV"
566557|NCT00903396|E1|Reported Event|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.
palonosetron hydrochloride: Given IV"
566558|NCT00903409|B3|Baseline|Total|Total of all reporting groups
566559|NCT00903409|B2|Baseline|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
566560|NCT00903409|B1|Baseline|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
566561|NCT00903409|P2|Participant Flow|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
566562|NCT00903409|P1|Participant Flow|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
566563|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
566564|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
566565|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
566566|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
566567|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
566568|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
566569|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
566570|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
566571|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
566572|NCT00903409|E3|Reported Event|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
566573|NCT00903409|E2|Reported Event|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
566574|NCT00903409|E1|Reported Event|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
566575|NCT00903448|B1|Baseline|Entire Study Population|
566576|NCT00903448|P2|Participant Flow|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
566577|NCT00903448|P1|Participant Flow|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
566578|NCT00903448|O2|Outcome|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
566579|NCT00903448|O1|Outcome|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
566580|NCT00903448|E2|Reported Event|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
566581|NCT00903448|E1|Reported Event|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
566582|NCT00903630|B4|Baseline|Total|Total of all reporting groups
566586|NCT00903630|P3|Participant Flow|Phase 2 - Dose Level 1|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
566587|NCT00903630|P2|Participant Flow|Phase 1 - Dose Level 2|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
566588|NCT00903630|P1|Participant Flow|Phase 1 - Dose Level 1|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
566589|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin fpr recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566590|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566591|NCT00903630|O3|Outcome|Phase 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566592|NCT00903630|O2|Outcome|Phase I - Dose Level 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566593|NCT00903630|O1|Outcome|Phase 1 - Dose Level 1|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566594|NCT00903630|O3|Outcome|Phase 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566595|NCT00903630|O2|Outcome|Phase I - Dose Level 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566596|NCT00903630|O1|Outcome|Phase 1 - Dose Level 1|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle
liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566597|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566598|NCT00903630|E3|Reported Event|Phase 2|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566599|NCT00903630|E2|Reported Event|Phase 1 - Dose Level 2|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose of 15 mg daily of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566600|NCT00903630|E1|Reported Event|Phase 1 - Dose Level 1|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle
pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
566601|NCT00903682|B3|Baseline|Total|Total of all reporting groups
566602|NCT00903682|B2|Baseline|Efavirenz|EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
566603|NCT00903682|B1|Baseline|Etravirine|ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
566604|NCT00903682|P2|Participant Flow|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
566605|NCT00903682|P1|Participant Flow|Etravirine|Etravirine (ETR TMC125) 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks
566606|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
566607|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
566608|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
566609|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
566610|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
566611|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
566612|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
566613|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
566614|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
566615|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
566616|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
566617|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
566618|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
566619|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
566620|NCT00903682|E2|Reported Event|Efavirenz|EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
566621|NCT00903682|E1|Reported Event|Etravirine|ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
566622|NCT00903695|B3|Baseline|Total|Total of all reporting groups
566623|NCT00903695|B2|Baseline|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
566624|NCT00903695|B1|Baseline|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
566625|NCT00903695|P2|Participant Flow|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
566626|NCT00903695|P1|Participant Flow|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
566627|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566628|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566629|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566630|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566631|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566632|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566633|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566688|NCT00904189|B1|Baseline|1Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.
Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
566634|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566635|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566636|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566637|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566638|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566639|NCT00903695|O2|Outcome|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
566640|NCT00903695|O1|Outcome|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
566641|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566642|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
566643|NCT00903695|E2|Reported Event|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
566644|NCT00903695|E1|Reported Event|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
566645|NCT00903877|B1|Baseline|Placebo Followed by T3|Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
566646|NCT00903877|P1|Participant Flow|Placebo Followed by T3|Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
566647|NCT00903877|O1|Outcome|Placebo Followed by T3|Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
566648|NCT00903877|E1|Reported Event|Placebo Followed by T3|All participants receive placebo, followed by 25 mcg of T3.
566649|NCT00903929|B1|Baseline|Eltrombopag|Eltrombopag: dose escalation
566650|NCT00903929|P4|Participant Flow|Eltrombopag 300 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
566651|NCT00903929|P3|Participant Flow|Eltrombopag 225 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
566652|NCT00903929|P2|Participant Flow|Eltrombopag 150 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
566653|NCT00903929|P1|Participant Flow|Eltrombopag 75 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
566654|NCT00903929|O1|Outcome|Eltrombopag|Eltrombopag: dose escalation
566655|NCT00903929|O1|Outcome|Eltrombopag|Eltrombopag: dose escalation
566656|NCT00903929|O1|Outcome|All Participants|
566657|NCT00903929|E1|Reported Event|Eltrombopag|Eltrombopag: dose escalation
566658|NCT00904007|B3|Baseline|Total|Total of all reporting groups
566659|NCT00904007|B2|Baseline|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
566660|NCT00904007|B1|Baseline|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
566661|NCT00904007|P2|Participant Flow|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
566662|NCT00904007|P1|Participant Flow|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
566663|NCT00904007|O2|Outcome|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
566664|NCT00904007|O1|Outcome|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
566665|NCT00904007|E2|Reported Event|Arm 2|Control clinicians received identical educational content in an online posting with email reminders.
566666|NCT00904007|E1|Reported Event|Arm 1|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
566667|NCT00904150|B3|Baseline|Total|Total of all reporting groups
566668|NCT00904150|B2|Baseline|2 No Migraine|Caucasian women with no personal history of migraine
566669|NCT00904150|B1|Baseline|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
566670|NCT00904150|P2|Participant Flow|2 No Migraine|Caucasian women with no personal history of migraine
566671|NCT00904150|P1|Participant Flow|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
566672|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
566673|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
566674|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
566675|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
566676|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
566677|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
566678|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
566679|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
566680|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
566681|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
566682|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
566683|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
566684|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
566685|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
566686|NCT00904150|E2|Reported Event|2 No Migraine|Caucasian women with no personal history of migraine
566687|NCT00904150|E1|Reported Event|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
566894|NCT00904995|E2|Reported Event|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
567275|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
566689|NCT00904189|P1|Participant Flow|1 Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.
Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
566690|NCT00904189|O1|Outcome|1 Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.
Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
566691|NCT00904189|O1|Outcome|Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.
Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
566692|NCT00904189|E1|Reported Event|Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.
Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
566693|NCT00904215|B1|Baseline|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
566694|NCT00904215|P1|Participant Flow|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
566695|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
566696|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
566697|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
566698|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
566699|NCT00904215|E1|Reported Event|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
566700|NCT00904371|B1|Baseline|Micardis® 80mg; MicardisPlus® 80/12.5 mg|
566701|NCT00904371|P1|Participant Flow|Micardis® 80mg; MicardisPlus® 80/12.5 mg|
566702|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566703|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566704|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566705|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566706|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566707|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566708|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566709|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566710|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566711|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566712|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566713|NCT00904371|E1|Reported Event|Micardis® 80mg MicardisPlus® 80/12.5 mg|
566714|NCT00904423|B1|Baseline|Vitamin D|
566715|NCT00904423|P1|Participant Flow|Vitamin D|
566716|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
566717|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
566718|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
566719|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
566720|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
566721|NCT00904423|E1|Reported Event|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
566722|NCT00904618|B1|Baseline|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
566723|NCT00904618|P1|Participant Flow|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
566724|NCT00904618|O2|Outcome|U-Method|The ‘U-Method’ is similar to the retropubic tape dissection.
566725|NCT00904618|O1|Outcome|'Hammock' Technique|The ‘Hammock’ technique is similar to the transobturator tape dissection.
566726|NCT00904618|O2|Outcome|U-Method|The U-Method is similar to the retropubic tape dissection
566727|NCT00904618|O1|Outcome|'Hammock' Technique|The 'Hammock' technique is similar to the transobturator tape dissection.
566728|NCT00904618|O1|Outcome|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
566729|NCT00904618|E1|Reported Event|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
566730|NCT00904670|B1|Baseline|Entire Study Population|Includes all randomized participants who received at least 1 dose of study medication.
566731|NCT00904670|P2|Participant Flow|OL Phase (NWP06); DB Phase (NWP06 First, Then Placebo)|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the first intervention period followed by placebo-matched to NWP06 oral suspension once daily for 1 week in the second intervention period.
566732|NCT00904670|P1|Participant Flow|OL Phase (NWP06); DB Phase (Placebo First, Then NWP06)|Placebo-matched to NWP06 oral suspension once daily for 1 week in the first intervention period followed by NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the second intervention period.
566733|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
566734|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
566735|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
566736|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
566737|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention period.
566738|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
566739|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
566740|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
566741|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
566742|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
566743|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
566744|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
566745|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
566746|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
566747|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
566748|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
566749|NCT00904670|E3|Reported Event|DB Phase (NWP06)|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60mg/day) for 1 week in either of the 2 intervention periods of the DB phase.
566750|NCT00904670|E2|Reported Event|DB Phase (Placebo)|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods of the DB phase.
566751|NCT00904670|E1|Reported Event|OL Phase (NWP06)|NWP06 oral suspension once daily optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day.
566752|NCT00904722|B1|Baseline|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
566753|NCT00904722|P1|Participant Flow|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
566754|NCT00904722|O1|Outcome|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
566755|NCT00904722|O1|Outcome|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
566756|NCT00904722|E1|Reported Event|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
566757|NCT00904748|B1|Baseline|Entire Study Population|Includes all participants who were randomized to any treatment sequence
566758|NCT00904748|P6|Participant Flow|Sequence 6|Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water
566985|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
566759|NCT00904748|P5|Participant Flow|Sequence 5|Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water)
566760|NCT00904748|P4|Participant Flow|Sequence 4|Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water
566761|NCT00904748|P3|Participant Flow|Sequence 3|Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water)
566762|NCT00904748|P2|Participant Flow|Sequence 2|Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water)
566763|NCT00904748|P1|Participant Flow|Sequence 1|Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water)
566764|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
566765|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
566766|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
566767|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
566768|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
566769|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
566770|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
566771|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
566772|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
566773|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
566774|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
566775|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
566776|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
566777|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
566778|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
566779|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
566780|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
566781|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
566782|NCT00904748|E4|Reported Event|Formulation Unspecified|Sildenafil 100 mg tablet: formulation unspecified
566783|NCT00904748|E3|Reported Event|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
566784|NCT00904748|E2|Reported Event|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
566785|NCT00904748|E1|Reported Event|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
566786|NCT00904826|B1|Baseline|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566787|NCT00904826|P1|Participant Flow|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566788|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566789|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566790|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566791|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566792|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566793|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566794|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566795|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566796|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566797|NCT00904826|E1|Reported Event|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
566798|NCT00904839|B3|Baseline|Total|Total of all reporting groups
566799|NCT00904839|B2|Baseline|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566800|NCT00904839|B1|Baseline|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566801|NCT00904839|P3|Participant Flow|Bevacizumab 5 mg + mFolfox6 (Phase II)|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566802|NCT00904839|P2|Participant Flow|Nintedanib 200 mg + mFolfox6|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566803|NCT00904839|P1|Participant Flow|Nintedanib 150 mg + mFolfox6|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566804|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566805|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566806|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566807|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
566808|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566809|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566810|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566811|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566812|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
566813|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566814|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566815|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
566816|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
567276|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
566817|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
566818|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566819|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566820|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566821|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566822|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566823|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566824|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566825|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566826|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566827|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566828|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566829|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566830|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566831|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566832|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566833|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
566834|NCT00904839|E2|Reported Event|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
566835|NCT00904839|E1|Reported Event|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
566836|NCT00904917|B5|Baseline|Total|Total of all reporting groups
566837|NCT00904917|B4|Baseline|Lecture (Children)|Children of the mother-child dyad in the lecture control group.
566838|NCT00904917|B3|Baseline|Lecture (Mothers)|Mothers of the mother-child dyad in the lecture control group.
566839|NCT00904917|B2|Baseline|Adapted PIP (Children)|Children of the mother-child dyad in the adapted PIP intervention.
566840|NCT00904917|B1|Baseline|Adapted PIP (Mothers)|Mothers of the mother-child dyad in the adapted PIP intervention.
566841|NCT00904917|P4|Participant Flow|Lecture (Children)|"Children of mothers who received education about depression.
Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family."
566842|NCT00904917|P3|Participant Flow|Lecture (Mothers)|"Mothers who received education about depression.
Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family."
566895|NCT00904995|E1|Reported Event|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
566896|NCT00905021|B1|Baseline|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:
Exemestane 25 mg by mouth every day.
Sunitinib 37.5 mg by mouth every day."
566843|NCT00904917|P2|Participant Flow|Adapted PIP (Children)|"Children of the mother-child dyad in the adapted PIP intervention for families of children with a depressed African American Mother.
Intervention Project: Eight 1 hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies"
566844|NCT00904917|P1|Participant Flow|Adapted PIP (Mothers)|"Mothers participated in an adapted PIP for the families of children with a depressed African American mother.
Prevention Intervention Project : Eight 1-hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies."
566845|NCT00904917|O4|Outcome|Lecture (Child)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
566846|NCT00904917|O3|Outcome|Lecture (Mother)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
566847|NCT00904917|O2|Outcome|Adapted PIP (Child)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.
The intervention was the Prevention Intervention Project."
566848|NCT00904917|O1|Outcome|Adapted PIP (Mother)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.
The intervention was the Prevention Intervention Project."
566849|NCT00904917|O4|Outcome|Lecture (Child)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
566850|NCT00904917|O3|Outcome|Lecture (Mother)|Mothers received psychoeducation about depression.
566851|NCT00904917|O2|Outcome|Adapted PIP (Child)|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
566852|NCT00904917|O1|Outcome|Adapted PIP (Mother)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.
The intervention was the Prevention Intervention Project."
566853|NCT00904917|O2|Outcome|Lecture|Mothers received psychoeducation about depression. The intervention was psychoeducation.
566854|NCT00904917|O1|Outcome|Adapted PIP|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
566855|NCT00904917|O2|Outcome|Lecture|Mothers received psychoeducation about depression. The intervention was psychoeducation.
566856|NCT00904917|O1|Outcome|Adapted PIP|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.
The intervention was the Prevention Intervention Project."
566857|NCT00904917|E2|Reported Event|Lecture|Mothers received psychoeducation about depression.
566858|NCT00904917|E1|Reported Event|Adapted PIP|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Preventive Intervention Project.
566859|NCT00904943|B3|Baseline|Total|Total of all reporting groups
566860|NCT00904943|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
566861|NCT00904943|B1|Baseline|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
566862|NCT00904943|P2|Participant Flow|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
566863|NCT00904943|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
566864|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
566865|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
566866|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
566867|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
566868|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
566869|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
566870|NCT00904982|B5|Baseline|Total|Total of all reporting groups
566871|NCT00904982|B4|Baseline|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
566897|NCT00905021|P1|Participant Flow|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:
Exemestane 25 mg by mouth every day.
Sunitinib 37.5 mg by mouth every day."
566898|NCT00905021|O1|Outcome|Exemestane Plus Sunitinib|This is a single arm study. All patients received Exemestane 25mg per day and Sunitinib 37.5 mg per day.
566899|NCT00905021|O1|Outcome|Exemestane Plus Sunitinib|"All patients enrolled on the study will receive treatment as follows:
Exemestane 25 mg by mouth every day.
Sunitinib 37.5 mg by mouth every day."
566900|NCT00905021|E1|Reported Event|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:
Exemestane 25 mg by mouth every day.
Sunitinib 37.5 mg by mouth every day."
566986|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
566872|NCT00904982|B3|Baseline|3 Incentive Group/Lottery|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken
566873|NCT00904982|B2|Baseline|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.
2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
566874|NCT00904982|B1|Baseline|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.
Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
566875|NCT00904982|P4|Participant Flow|4 Combined Group/Lottery and Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.
Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an"
566876|NCT00904982|P3|Participant Flow|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.
Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
566877|NCT00904982|P2|Participant Flow|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.
2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
566878|NCT00904982|P1|Participant Flow|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.
Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.
Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
566879|NCT00904982|O4|Outcome|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
566984|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
566880|NCT00904982|O3|Outcome|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.
Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
566881|NCT00904982|O2|Outcome|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.
2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
566882|NCT00904982|O1|Outcome|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.
Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.
Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
566883|NCT00904982|E4|Reported Event|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
566884|NCT00904982|E3|Reported Event|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.
Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
566885|NCT00904982|E2|Reported Event|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.
2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
566886|NCT00904982|E1|Reported Event|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.
Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
566887|NCT00904995|B3|Baseline|Total|Total of all reporting groups
566888|NCT00904995|B2|Baseline|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
566889|NCT00904995|B1|Baseline|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
566890|NCT00904995|P2|Participant Flow|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
566891|NCT00904995|P1|Participant Flow|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
566892|NCT00904995|O2|Outcome|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
566893|NCT00904995|O1|Outcome|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
566901|NCT00905034|B1|Baseline|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
566902|NCT00905034|P1|Participant Flow|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
566903|NCT00905034|O1|Outcome|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
566904|NCT00905034|E1|Reported Event|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
566905|NCT00905125|B3|Baseline|Total|Total of all reporting groups
566906|NCT00905125|B2|Baseline|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566907|NCT00905125|B1|Baseline|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566908|NCT00905125|P2|Participant Flow|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566909|NCT00905125|P1|Participant Flow|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566910|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566911|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566912|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566913|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566914|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566915|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566916|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566917|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566918|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566919|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566920|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566921|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566922|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566923|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566924|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566925|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566926|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566927|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566928|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566929|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566930|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566931|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566932|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566933|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566934|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566935|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566936|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566937|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566938|NCT00905125|E2|Reported Event|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
566939|NCT00905125|E1|Reported Event|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
566940|NCT00905151|B1|Baseline|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
566941|NCT00905151|P1|Participant Flow|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
566942|NCT00905151|O1|Outcome|HIV Positive|Across-sectional analysis of 200 HIV+ patients with varying levels of kidney function
566943|NCT00905151|E1|Reported Event|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
566944|NCT00898443|B3|Baseline|Total|Total of all reporting groups
566945|NCT00898443|B2|Baseline|Epidural Anesthetic Group|This is the experimental group for this study.
566946|NCT00898443|B1|Baseline|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
566947|NCT00898443|P2|Participant Flow|Epidural Anesthetic Group|This is the experimental group for this study.
566948|NCT00898443|P1|Participant Flow|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
566949|NCT00898443|O2|Outcome|Epidural Anesthetic Group|This is the experimental group for this study.
566950|NCT00898443|O1|Outcome|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
566951|NCT00898443|O2|Outcome|Epidural Anesthetic Group|This is the experimental group for this study.
567277|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
566952|NCT00898443|O1|Outcome|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
566953|NCT00898443|E2|Reported Event|Epidural Anesthetic Group|This is the experimental group for this study.
566954|NCT00898443|E1|Reported Event|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
566955|NCT00898560|B1|Baseline|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period"
566956|NCT00898560|P1|Participant Flow|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period"
566957|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period"
566958|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
566959|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period"
566960|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
566961|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period"
566962|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
566963|NCT00898560|E2|Reported Event|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
566964|NCT00898560|E1|Reported Event|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period"
566965|NCT00898677|B5|Baseline|Total|Total of all reporting groups
566966|NCT00898677|B4|Baseline|Placebo|"Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
Baseline measure Participants reported are those participants that recieved study treatment."
566967|NCT00898677|B3|Baseline|Sumatriptan 100 mg|"Sumatriptan 100 mg orally once for treatment of single migraine attack
Baseline measure Participants reported are those participants that recieved study treatment."
566968|NCT00898677|B2|Baseline|Rizatriptan 10 mg|"Rizatriptan 10 mg orally once for treatment of single migraine attack
Baseline measure Participants reported are those participants that recieved study treatment."
566969|NCT00898677|B1|Baseline|Rizatriptan 5 mg|"Rizatriptan 5 mg orally once for treatment of single migraine attack.
Baseline measure Participants reported are those participants that recieved study treatment."
566970|NCT00898677|P4|Participant Flow|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
566971|NCT00898677|P3|Participant Flow|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
566972|NCT00898677|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
566973|NCT00898677|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
566974|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
566975|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
566976|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
566977|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
566978|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
566979|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
566980|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
566981|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
566982|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
566983|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
567278|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
566987|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
566988|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
566989|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
566990|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
566991|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
566992|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
566993|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
566994|NCT00898677|E4|Reported Event|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
566995|NCT00898677|E3|Reported Event|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
566996|NCT00898677|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
566997|NCT00898677|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
566998|NCT00898807|B3|Baseline|Total|Total of all reporting groups
566999|NCT00898807|B2|Baseline|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention
placebo : daily for 9 weeks"
567000|NCT00898807|B1|Baseline|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention
citalopram : target dose 30mg daily for 9 weeks"
567001|NCT00898807|P2|Participant Flow|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention
placebo : daily for 9 weeks"
567002|NCT00898807|P1|Participant Flow|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention
citalopram : target dose 30mg daily for 9 weeks"
567003|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention
placebo : daily for 9 weeks"
567004|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention
citalopram : target dose 30mg daily for 9 weeks"
567005|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention
placebo : daily for 9 weeks"
567006|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention
citalopram : target dose 30mg daily for 9 weeks"
567007|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention
placebo : daily for 9 weeks"
567008|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention
citalopram : target dose 30mg daily for 9 weeks"
567009|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention
placebo : daily for 9 weeks"
567010|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention
citalopram : target dose 30mg daily for 9 weeks"
567011|NCT00898807|E2|Reported Event|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention
placebo : daily for 9 weeks"
567012|NCT00898807|E1|Reported Event|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention
citalopram : target dose 30mg daily for 9 weeks"
567013|NCT00905164|B3|Baseline|Total|Total of all reporting groups
567014|NCT00905164|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules,2 x 25 mg (test) dosed in second period
567015|NCT00905164|B1|Baseline|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
567016|NCT00905164|P2|Participant Flow|Topomax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
567017|NCT00905164|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topomax® Capsules, 2 x 25 mg (reference) dosed in second period
567018|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
567019|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
567020|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
567021|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
567022|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
567023|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
567024|NCT00905255|B3|Baseline|Total|Total of all reporting groups
567025|NCT00905255|B2|Baseline|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment.
567026|NCT00905255|B1|Baseline|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
567027|NCT00905255|P2|Participant Flow|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment.
567028|NCT00905255|P1|Participant Flow|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
567029|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
567030|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
567031|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
567034|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
567035|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
567036|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
567037|NCT00905255|O2|Outcome|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
567038|NCT00905255|O1|Outcome|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
567039|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
567040|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
567041|NCT00905255|E2|Reported Event|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
567042|NCT00905255|E1|Reported Event|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
567043|NCT00905268|B5|Baseline|Total|Total of all reporting groups
567044|NCT00905268|B4|Baseline|D: Placebo|"placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567045|NCT00905268|B3|Baseline|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567046|NCT00905268|B2|Baseline|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567047|NCT00905268|B1|Baseline|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567048|NCT00905268|P4|Participant Flow|D: Placebo|"placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567049|NCT00905268|P3|Participant Flow|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567050|NCT00905268|P2|Participant Flow|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567051|NCT00905268|P1|Participant Flow|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567052|NCT00905268|O4|Outcome|D: Placebo|"placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567053|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567054|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567055|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567056|NCT00905268|O4|Outcome|D: Placebo|"placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567057|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567058|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567059|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567060|NCT00905268|O4|Outcome|D: Placebo|"placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567061|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567062|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567063|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567064|NCT00905268|O4|Outcome|D: Placebo|"placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567065|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567066|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567067|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567068|NCT00905268|O4|Outcome|D: Placebo|"placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567069|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567070|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567071|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567072|NCT00905268|O4|Outcome|D: Placebo|"placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567073|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567074|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567075|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567076|NCT00905268|E4|Reported Event|D: Placebo|"placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567077|NCT00905268|E3|Reported Event|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567078|NCT00905268|E2|Reported Event|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567079|NCT00905268|E1|Reported Event|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
567080|NCT00905307|B7|Baseline|Total|Total of all reporting groups
567081|NCT00905307|B6|Baseline|Placebo|Placebo QD for 6 weeks
567082|NCT00905307|B5|Baseline|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567083|NCT00905307|B4|Baseline|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567084|NCT00905307|B3|Baseline|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567085|NCT00905307|B2|Baseline|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567086|NCT00905307|B1|Baseline|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
567087|NCT00905307|P6|Participant Flow|Placebo|Placebo QD for 6 weeks
567088|NCT00905307|P5|Participant Flow|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567089|NCT00905307|P4|Participant Flow|OPC-34712 High Dose|5.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567090|NCT00905307|P3|Participant Flow|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567091|NCT00905307|P2|Participant Flow|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567092|NCT00905307|P1|Participant Flow|OPC-34712 0.25 mg|0.25 mg once daily (QD) for 6 weeks
567093|NCT00905307|O6|Outcome|Placebo|Placebo QD
567094|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567095|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
567096|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567097|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physicna could request a dose increase, if needed for efficacy, based on clinical judgment.
567098|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
567099|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
567100|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567101|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
567102|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567103|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567104|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
567106|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567107|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567108|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567109|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567110|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
567111|NCT00905307|O6|Outcome|Placebo|Placebo QD
567112|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
567113|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
567114|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
567115|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
567116|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD
567117|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
567118|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567119|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
567120|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567121|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567122|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
567123|NCT00905307|O6|Outcome|Placebo|Placebo QD
567124|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
567125|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
567126|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
567127|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
567128|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD
567129|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
567130|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg.After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567131|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567132|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567133|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567134|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
567135|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
567136|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
567137|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
567138|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment , the physician could request a dose increase, if needed for efficacy, based on clinical judgment
567139|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
567140|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
567141|NCT00905307|E6|Reported Event|Placebo|Placebo QD
567358|NCT00907738|P1|Participant Flow|Base Protocol 001|Vorinostat 400 mg daily (QD)
567142|NCT00905307|E5|Reported Event|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
567143|NCT00905307|E4|Reported Event|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567144|NCT00905307|E3|Reported Event|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567145|NCT00905307|E2|Reported Event|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
567146|NCT00905307|E1|Reported Event|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
567147|NCT00905346|B3|Baseline|Total|Total of all reporting groups
567148|NCT00905346|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
567149|NCT00905346|B1|Baseline|Topiramate (Test) First|Topiramate Capsules 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
567150|NCT00905346|P2|Participant Flow|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
567151|NCT00905346|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules 2 x 25 mg (reference) dosed in second period
567152|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
567153|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
567154|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
567155|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
567156|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
567157|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
567158|NCT00905359|B3|Baseline|Total|Total of all reporting groups
567159|NCT00905359|B2|Baseline|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567160|NCT00905359|B1|Baseline|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567161|NCT00905359|P2|Participant Flow|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567162|NCT00905359|P1|Participant Flow|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567163|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567164|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567165|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567166|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567167|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567168|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567169|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567170|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567171|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567172|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567173|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567174|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567175|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567176|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567177|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567178|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567179|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567180|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567181|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567182|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
572642|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
567183|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567184|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567185|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567186|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567187|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567188|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567189|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567190|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567191|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567192|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567193|NCT00905359|E2|Reported Event|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
567194|NCT00905359|E1|Reported Event|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
567195|NCT00905424|B3|Baseline|Total|Total of all reporting groups
567196|NCT00905424|B2|Baseline|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
567197|NCT00905424|B1|Baseline|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
567198|NCT00905424|P2|Participant Flow|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
567199|NCT00905424|P1|Participant Flow|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
567200|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567201|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567202|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567203|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567204|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567205|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
568002|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
567206|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567207|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567208|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567209|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567210|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567211|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567212|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567213|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567214|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567215|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567216|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567217|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567218|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567219|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
568068|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
567220|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567221|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567222|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567223|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567224|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567225|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567226|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567227|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567228|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567229|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567230|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567231|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567232|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567233|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
568069|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
567234|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
567235|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
567236|NCT00905424|E2|Reported Event|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
567237|NCT00905424|E1|Reported Event|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
567238|NCT00905437|B3|Baseline|Total|Total of all reporting groups
567239|NCT00905437|B2|Baseline|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
567240|NCT00905437|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
567241|NCT00905437|P2|Participant Flow|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
567242|NCT00905437|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
567243|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
567244|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
567245|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
567246|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
567247|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
567248|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
567249|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
567250|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
567251|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
567252|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
567253|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
567254|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
567255|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
567256|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
567257|NCT00905437|E2|Reported Event|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
567258|NCT00905437|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
567259|NCT00905489|B1|Baseline|Total.|"All patients enrolled in study.
All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
567260|NCT00905489|P1|Participant Flow|Total.|"All patients enrolled in study.
All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
567261|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
567262|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
567263|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
567264|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
567265|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
567266|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
567267|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
567268|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
567269|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
567270|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
567271|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
567272|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
567279|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
567280|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
567281|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
567282|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
567283|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
567284|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
567285|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
567286|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
567287|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
567288|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
567289|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
567290|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
567291|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
567292|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
567293|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
567294|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
567295|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
567296|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
567297|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
567298|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
567299|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
567300|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
567301|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
567302|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
567303|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
567304|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
567305|NCT00905489|E1|Reported Event|Total.|"All patients enrolled in study.
All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
567306|NCT00907517|B6|Baseline|Total|Total of all reporting groups
567307|NCT00907517|B5|Baseline|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567308|NCT00907517|B4|Baseline|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567309|NCT00907517|B3|Baseline|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567310|NCT00907517|B2|Baseline|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567311|NCT00907517|B1|Baseline|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567312|NCT00907517|P5|Participant Flow|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567313|NCT00907517|P4|Participant Flow|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567314|NCT00907517|P3|Participant Flow|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567315|NCT00907517|P2|Participant Flow|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567316|NCT00907517|P1|Participant Flow|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 intravenously (IV) on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour continuous intravenous infusion (CIV) on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567939|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567317|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567318|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567319|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567320|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567321|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567322|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567323|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567324|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567325|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567326|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567327|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567328|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567329|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567330|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567331|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567332|NCT00907517|E5|Reported Event|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567333|NCT00907517|E4|Reported Event|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567334|NCT00907517|E3|Reported Event|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567335|NCT00907517|E2|Reported Event|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567359|NCT00907738|O5|Outcome|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
568000|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
567336|NCT00907517|E1|Reported Event|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
567337|NCT00907621|B3|Baseline|Total|Total of all reporting groups
567338|NCT00907621|B2|Baseline|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
The Control group will have no intervention.
The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time."
567339|NCT00907621|B1|Baseline|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.
The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time."
567340|NCT00907621|P2|Participant Flow|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
The Control group will have no intervention."
567341|NCT00907621|P1|Participant Flow|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
567342|NCT00907621|O2|Outcome|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
The Control group will have no intervention."
567343|NCT00907621|O1|Outcome|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
567344|NCT00907621|O2|Outcome|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
The Control group will have no intervention."
567345|NCT00907621|O1|Outcome|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
567346|NCT00907621|E2|Reported Event|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
The Control group will have no intervention."
567347|NCT00907621|E1|Reported Event|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:
Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
567348|NCT00907738|B6|Baseline|Total|Total of all reporting groups
567349|NCT00907738|B5|Baseline|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
567350|NCT00907738|B4|Baseline|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
567351|NCT00907738|B3|Baseline|Base Protocol 008|vorinostat 400 mg QD
567352|NCT00907738|B2|Baseline|Base Protocol 006|vorinostat 200 mg twice daily (BID)
567353|NCT00907738|B1|Baseline|Base Protocol 001|Vorinostat 400 mg daily (QD)
567354|NCT00907738|P5|Participant Flow|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
567355|NCT00907738|P4|Participant Flow|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
567356|NCT00907738|P3|Participant Flow|Base Protocol 008|vorinostat 400 mg QD
567357|NCT00907738|P2|Participant Flow|Base Protocol 006|vorinostat 200 mg twice daily (BID)
572643|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
567360|NCT00907738|O4|Outcome|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
567361|NCT00907738|O3|Outcome|Base Protocol 008|vorinostat 400 mg QD
567362|NCT00907738|O2|Outcome|Base Protocol 006|vorinostat 200 mg twice daily (BID)
567363|NCT00907738|O1|Outcome|Base Protocol 001|Vorinostat 400 mg daily (QD)
567364|NCT00907738|E9|Reported Event|Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)|
567365|NCT00907738|E8|Reported Event|Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21)|
567366|NCT00907738|E7|Reported Event|Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21)|
567367|NCT00907738|E6|Reported Event|Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21)|
567368|NCT00907738|E5|Reported Event|Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7)|
567369|NCT00907738|E4|Reported Event|Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21)|
567370|NCT00907738|E3|Reported Event|Base Protocol 008 (Vorinostat 400 mg Once Daily [QD])|
567371|NCT00907738|E2|Reported Event|Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID])|
567372|NCT00907738|E1|Reported Event|Base Protocol 001 (Vorinostat 400 mg Once Daily [QD])|
567373|NCT00907777|B3|Baseline|Total|Total of all reporting groups
567374|NCT00907777|B2|Baseline|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567375|NCT00907777|B1|Baseline|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567376|NCT00907777|P2|Participant Flow|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567377|NCT00907777|P1|Participant Flow|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567378|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567379|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567380|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567381|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567382|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567383|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567384|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567385|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567386|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567417|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
567387|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567388|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567389|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567390|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567391|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567392|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567393|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567394|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567395|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567396|NCT00907777|E2|Reported Event|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567397|NCT00907777|E1|Reported Event|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
567398|NCT00907803|B4|Baseline|Total|Total of all reporting groups
567399|NCT00907803|B3|Baseline|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
567400|NCT00907803|B2|Baseline|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
567401|NCT00907803|B1|Baseline|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
567402|NCT00907803|P3|Participant Flow|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
567403|NCT00907803|P2|Participant Flow|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
567404|NCT00907803|P1|Participant Flow|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
567405|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
567406|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
567407|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
567408|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
567409|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
567410|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
567411|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
567412|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
567413|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
567414|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
567415|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
567416|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
567418|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
567419|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
567420|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
567421|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
567422|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
567423|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
567424|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
567425|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
567426|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
567427|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
567428|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
567429|NCT00907803|E3|Reported Event|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
567430|NCT00907803|E2|Reported Event|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
567431|NCT00907803|E1|Reported Event|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
567432|NCT00907881|B1|Baseline|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s)."
567433|NCT00907881|P1|Participant Flow|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s)."
567434|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s)."
567435|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s)."
567436|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s)."
567437|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s)."
567438|NCT00907881|E1|Reported Event|All Participants|
567439|NCT00907907|B3|Baseline|Total|Total of all reporting groups
567440|NCT00907907|B2|Baseline|Cellcept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
567441|NCT00907907|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
567442|NCT00907907|P2|Participant Flow|Cellcept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
567443|NCT00907907|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
567444|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
567445|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
567446|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
567447|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
567448|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
567449|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
567450|NCT00908011|B3|Baseline|Total|Total of all reporting groups
567451|NCT00908011|B2|Baseline|Standard Care|"Increased dose of rosuvastatin to 20mg/day
Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
567452|NCT00908011|B1|Baseline|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)
Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
567453|NCT00908011|P2|Participant Flow|Standard Care|"Increased dose of rosuvastatin to 20mg/day
Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
567454|NCT00908011|P1|Participant Flow|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)
Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
567455|NCT00908011|O2|Outcome|Standard Care|"Increased dose of rosuvastatin to 20mg/day
Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
567456|NCT00908011|O1|Outcome|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)
Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
567457|NCT00908011|E2|Reported Event|Standard Care|"Increased dose of rosuvastatin to 20mg/day
Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
567458|NCT00908011|E1|Reported Event|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)
Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
567459|NCT00908037|B8|Baseline|Total|Total of all reporting groups
567729|NCT00908596|B1|Baseline|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567460|NCT00908037|B7|Baseline|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Par aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Par of East Asian ancestry began at 0.8 mg/kg/day. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
567461|NCT00908037|B6|Baseline|Part 2 (Randomized Period) Cohort 3-Placebo|Par aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Par of East Asian ancestry received 0.8 mg/kg/day. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567462|NCT00908037|B5|Baseline|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Par aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, par with a weight of &lt;27 kg received 25 mg QD and par with a weight of &gt;=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of &lt;27 kg received 12.5 mg QD and par with a weight of &gt;=27 kg received 25 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
567463|NCT00908037|B4|Baseline|Part 2 (Randomized Period) Cohort 2-Placebo|Par aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Par with a body weight of &lt;=27 kg received 25 mg QD and par with a body weight of &gt;=27 kg QD received 50 mg QD. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
567464|NCT00908037|B3|Baseline|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Par aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
567465|NCT00908037|B2|Baseline|Part 2 (Randomized Period) Cohort 1-Placebo|Par aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
567466|NCT00908037|B1|Baseline|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of East Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
567467|NCT00908037|P12|Participant Flow|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567468|NCT00908037|P11|Participant Flow|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567524|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567469|NCT00908037|P10|Participant Flow|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567470|NCT00908037|P9|Participant Flow|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567471|NCT00908037|P8|Participant Flow|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
567472|NCT00908037|P7|Participant Flow|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567473|NCT00908037|P6|Participant Flow|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567474|NCT00908037|P5|Participant Flow|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567475|NCT00908037|P4|Participant Flow|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567476|NCT00908037|P3|Participant Flow|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567477|NCT00908037|P2|Participant Flow|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567478|NCT00908037|P1|Participant Flow|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567479|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567480|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567481|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567482|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567483|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567484|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567485|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567486|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567487|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567488|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, as approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567489|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
567490|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567491|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567492|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose eltrombopag was 37.5 mg QD. The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567493|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567494|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567495|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567496|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567646|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
567497|NCT00908037|O1|Outcome|Part 2/ 3 Eltrombopag Open-Label Period|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
567498|NCT00908037|O2|Outcome|Part 2 Randomized Period - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
567499|NCT00908037|O1|Outcome|Part 2 Randomized Period - Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo QD for 7 weeks.
567500|NCT00908037|O1|Outcome|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of East Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
567501|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567502|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567503|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567504|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567505|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
567506|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567507|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567508|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567509|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567647|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
567648|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
567510|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567511|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567512|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567513|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567514|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567515|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567516|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567517|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
567518|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567519|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567520|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567521|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567522|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567523|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567649|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
567650|NCT00908141|B3|Baseline|Total|Total of all reporting groups
567525|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
567526|NCT00908037|O3|Outcome|Part 2 Randomized Period - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
567527|NCT00908037|O2|Outcome|Part 2 Randomized Period - Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
567528|NCT00908037|O1|Outcome|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
567529|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567530|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567531|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567532|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567533|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
567534|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567535|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567536|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567537|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567651|NCT00908141|B2|Baseline|Group B: Sargramostim (3 x Week)|"GROUP B:
Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
572644|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
567538|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567539|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567540|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567541|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
567542|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 7 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight <27 kg: 25 mg QD, Weight >=27 kg: 50 mg QD; east Asian ancestry subjects Weight <27 kg: 12.5 mg QD, Weight >=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
567543|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
567544|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight <27 kg: 25 mg QD, Weight >=27 kg: 50 mg QD; east Asian ancestry subjects Weight <27 kg: 12.5 mg QD, Weight >=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
567545|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
567546|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
567547|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
567548|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
567549|NCT00908037|O4|Outcome|Part 2/3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
567652|NCT00908141|B1|Baseline|Group A: Sargramostim (Days 1-14)|"GROUP A:
Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
567550|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
567551|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
567552|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a body weight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
567553|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the studyat 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567554|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567555|NCT00908037|O1|Outcome|Part 2/ 3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567556|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567557|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
567558|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567559|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567560|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567561|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567562|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567653|NCT00908141|P2|Participant Flow|Group B:Sargramostim (3 x Week)|"GROUP B:
Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
567563|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567564|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567565|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567566|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
567567|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567568|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567569|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567570|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567571|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567572|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567573|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567574|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567575|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567654|NCT00908141|P1|Participant Flow|Group A: Sargramostim (Days 1-14)|"GROUP A:
Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
567655|NCT00908141|O2|Outcome|Group B: Sargramostim (3 x Week)|"GROUP B:
Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
567576|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567577|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567578|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567579|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567580|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567581|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567582|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567583|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567584|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567585|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567656|NCT00908141|O1|Outcome|Group A: Sargramostim (Days 1-14)|"GROUP A:
Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
567657|NCT00908141|E2|Reported Event|Group B: Sargramostim (3 x Week)|"GROUP B:
Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
567586|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567587|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
567588|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567589|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567590|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567591|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567592|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567593|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567594|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567595|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567596|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567658|NCT00908141|E1|Reported Event|Group A: Sargramostim (Days 1-14)|"GROUP A:
Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
567659|NCT00908232|B1|Baseline|All Study Participants|bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
567860|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
567597|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567598|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567599|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567600|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567601|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567602|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567603|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
567604|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567817|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567605|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of &lt;=27 kg received 25 mg QD and participants with a body weight of &gt;=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567606|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567607|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567608|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567609|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567610|NCT00908037|O2|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
567611|NCT00908037|O1|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
567612|NCT00908037|O2|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
567613|NCT00908037|O1|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
567614|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567615|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
567616|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567617|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567618|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
567619|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
567620|NCT00908037|E4|Reported Event|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose unless adjustments were warranted according to the dosing guidelines. Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2.
567621|NCT00908037|E3|Reported Event|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of &lt;27 kg received 25 mg QD, and par with a body weight of &gt;=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of &lt;27 kg received 12.5 mg QD, and with a body weight of &gt;=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
567622|NCT00908037|E2|Reported Event|Part 2 (Randomized Period) -Placebo|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
567623|NCT00908037|E1|Reported Event|Part 1 (Dose-Finding Period)|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight &lt;27 kg: 25 mg QD, Weight &gt;=27 kg: 50 mg QD; east Asian ancestry subjects Weight &lt;27 kg: 12.5 mg QD, Weight &gt;=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
567624|NCT00908076|B3|Baseline|Total|Total of all reporting groups
567625|NCT00908076|B2|Baseline|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
567626|NCT00908076|B1|Baseline|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
567627|NCT00908076|P2|Participant Flow|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
567628|NCT00908076|P1|Participant Flow|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
567629|NCT00908076|O2|Outcome|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
567630|NCT00908076|O1|Outcome|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
567631|NCT00908076|E2|Reported Event|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
567632|NCT00908076|E1|Reported Event|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
567633|NCT00908115|B1|Baseline|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
567634|NCT00908115|P1|Participant Flow|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
567635|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
567636|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
567637|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
567638|NCT00908115|E1|Reported Event|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
567639|NCT00908128|B3|Baseline|Total|Total of all reporting groups
567640|NCT00908128|B2|Baseline|CellCept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
567641|NCT00908128|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
567642|NCT00908128|P2|Participant Flow|CellCept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
567643|NCT00908128|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
567644|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
567645|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
567660|NCT00908232|P4|Participant Flow|SD: Bortezomib+Dexamethasone+Lenalidomide (VDR)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
567661|NCT00908232|P3|Participant Flow|SD: Bortezomib+Dexamethasone+Cyclophosphamide (VDC)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and cyclophosphamide 500 mg, orally daily, days 1, 8 and 15 for cycle 5 to 8
567662|NCT00908232|P2|Participant Flow|Stable Disease: Bortezomib + Dexamethasone (VD)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
567663|NCT00908232|P1|Participant Flow|Cycle 1 to 4: Bortezomib + Dexamethasone (VD)|bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
567664|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
567665|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
567666|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
567667|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
567668|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
567669|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
567670|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
567671|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
567672|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
567673|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
567674|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
567675|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
567728|NCT00908596|B2|Baseline|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567894|NCT00909324|B3|Baseline|Total|Total of all reporting groups
567676|NCT00908232|E2|Reported Event|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
567677|NCT00908232|E1|Reported Event|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
567678|NCT00908310|B1|Baseline|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
567679|NCT00908310|P1|Participant Flow|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
567680|NCT00908310|O1|Outcome|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
567681|NCT00908310|E1|Reported Event|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
567682|NCT00908349|B1|Baseline|Oxcarbazepine XR|"Open Label Study
Oxcarbazepine XR: Open Label Study"
567683|NCT00908349|P1|Participant Flow|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
567684|NCT00908349|O1|Outcome|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
567685|NCT00908349|E1|Reported Event|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
567686|NCT00908375|B3|Baseline|Total|Total of all reporting groups
567687|NCT00908375|B2|Baseline|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.
Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
567688|NCT00908375|B1|Baseline|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
567689|NCT00908375|P2|Participant Flow|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.
Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
567690|NCT00908375|P1|Participant Flow|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
567691|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.
Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
567692|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
567693|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.
Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
567694|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
567695|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.
Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
567696|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
568001|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
567697|NCT00908375|E2|Reported Event|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.
Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
567698|NCT00908375|E1|Reported Event|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
567699|NCT00908388|B1|Baseline|GORE Conformable TAG® Device Surgical Implant|Subjects prospectively treated with the GORE Conformable TAG® Thoracic Endoprosthesis for acute complicated type B aortic dissection
567700|NCT00908388|P1|Participant Flow|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
567701|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
567702|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
567703|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
567704|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
567705|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
567706|NCT00908388|E1|Reported Event|CTAG Device Dissection Subjects|
567707|NCT00908583|B1|Baseline|All Study Participants|Combined study participants, all phases.
567708|NCT00908583|P1|Participant Flow|All Study Participants|Combined study participants all phases.
567709|NCT00908583|O1|Outcome|All Transplanted Participants|Combined phases, transplanted patients.
567710|NCT00908583|O1|Outcome|All Study Participants|All study participants combined.4 participants were enrolled in multiple groups or phases. They are only counted once.
567711|NCT00908583|O1|Outcome|All Study Participants|All study participants combined. Counting participants only once even though 7 participants were enrolled in multiple phases.
567712|NCT00908583|O8|Outcome|Phase 5, Single Stage|"Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567713|NCT00908583|O7|Outcome|Phase 4, Single Stage|"Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567714|NCT00908583|O6|Outcome|Phase 3, Cycle 2|"Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567715|NCT00908583|O5|Outcome|Phase 3, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567716|NCT00908583|O4|Outcome|Phase 2 Cycle 2|"Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567717|NCT00908583|O3|Outcome|Phase 2, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567718|NCT00908583|O2|Outcome|Phase 1 Cycle 2|"Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567719|NCT00908583|O1|Outcome|Phase 1, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567720|NCT00908583|E5|Reported Event|Phase 5, Single Stage|"Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567721|NCT00908583|E4|Reported Event|Phase 4, Single Stage|"Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567722|NCT00908583|E3|Reported Event|Phase 3|"Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567723|NCT00908583|E2|Reported Event|Phase 2, Two Stages|"Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567724|NCT00908583|E1|Reported Event|Phase 1, Two Stages|"Deletional, two stage approach with terminal plasmapheresis
Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
567725|NCT00908596|B5|Baseline|Total|Total of all reporting groups
567726|NCT00908596|B4|Baseline|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567727|NCT00908596|B3|Baseline|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567730|NCT00908596|P4|Participant Flow|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567731|NCT00908596|P3|Participant Flow|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567732|NCT00908596|P2|Participant Flow|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567733|NCT00908596|P1|Participant Flow|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567734|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567735|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567736|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567737|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567738|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567739|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567740|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567741|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567742|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567743|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567744|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567745|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567746|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567747|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567748|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567749|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567750|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567751|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567752|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567753|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567754|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567755|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567793|NCT00908687|E3|Reported Event|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
A/H5N1: A/H5N1 Low Dose
LT Adjuvant Patch: LT Adjuvant Patch High Dose"
567756|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567757|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567758|NCT00908596|E4|Reported Event|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567759|NCT00908596|E3|Reported Event|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567760|NCT00908596|E2|Reported Event|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567761|NCT00908596|E1|Reported Event|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
567762|NCT00908648|B3|Baseline|Total|Total of all reporting groups
567763|NCT00908648|B2|Baseline|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
567764|NCT00908648|B1|Baseline|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
567765|NCT00908648|P2|Participant Flow|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
567766|NCT00908648|P1|Participant Flow|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
567767|NCT00908648|O2|Outcome|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
567768|NCT00908648|O1|Outcome|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
567769|NCT00908648|O2|Outcome|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
567770|NCT00908648|O1|Outcome|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
567771|NCT00908687|B7|Baseline|Total|Total of all reporting groups
567772|NCT00908687|B6|Baseline|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
A/H5N1: A/H5N1 High Dose
LT Adjuvant Patch: LT Adjuvant Patch High Dose"
567773|NCT00908687|B5|Baseline|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1: A/H5N1 High Dose
LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
567774|NCT00908687|B4|Baseline|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0
A/H5N1: A/H5N1 High Dose"
567775|NCT00908687|B3|Baseline|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
A/H5N1: A/H5N1 Low Dose
LT Adjuvant Patch: LT Adjuvant Patch High Dose"
567776|NCT00908687|B2|Baseline|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1: A/H5N1 Low Dose
LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
567777|NCT00908687|B1|Baseline|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0
A/H5N1: A/H5N1 Low Dose"
567778|NCT00908687|P6|Participant Flow|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
A/H5N1: A/H5N1 High Dose
LT Adjuvant Patch: LT Adjuvant Patch High Dose"
567779|NCT00908687|P5|Participant Flow|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1: A/H5N1 High Dose
LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
567780|NCT00908687|P4|Participant Flow|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0
A/H5N1: A/H5N1 High Dose"
567781|NCT00908687|P3|Participant Flow|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
A/H5N1: A/H5N1 Low Dose
LT Adjuvant Patch: LT Adjuvant Patch High Dose"
567782|NCT00908687|P2|Participant Flow|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1: A/H5N1 Low Dose
LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
567783|NCT00908687|P1|Participant Flow|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0
A/H5N1: A/H5N1 Low Dose"
567784|NCT00908687|O6|Outcome|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
A/H5N1: A/H5N1 High Dose
LT Adjuvant Patch: LT Adjuvant Patch High Dose"
567785|NCT00908687|O5|Outcome|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1: A/H5N1 High Dose
LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
567786|NCT00908687|O4|Outcome|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0
A/H5N1: A/H5N1 High Dose"
567787|NCT00908687|O3|Outcome|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
A/H5N1: A/H5N1 Low Dose
LT Adjuvant Patch: LT Adjuvant Patch High Dose"
567788|NCT00908687|O2|Outcome|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1: A/H5N1 Low Dose
LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
567789|NCT00908687|O1|Outcome|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0
A/H5N1: A/H5N1 Low Dose"
567790|NCT00908687|E6|Reported Event|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
A/H5N1: A/H5N1 High Dose
LT Adjuvant Patch: LT Adjuvant Patch High Dose"
567791|NCT00908687|E5|Reported Event|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1: A/H5N1 High Dose
LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
567792|NCT00908687|E4|Reported Event|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0
A/H5N1: A/H5N1 High Dose"
567938|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567794|NCT00908687|E2|Reported Event|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1: A/H5N1 Low Dose
LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
567795|NCT00908687|E1|Reported Event|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0
A/H5N1: A/H5N1 Low Dose"
567796|NCT00908882|B3|Baseline|Total|Total of all reporting groups
567797|NCT00908882|B2|Baseline|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567798|NCT00908882|B1|Baseline|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567799|NCT00908882|P2|Participant Flow|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567800|NCT00908882|P1|Participant Flow|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567801|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567802|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567803|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567804|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567805|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567806|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567807|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567808|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567809|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567810|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567811|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567812|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567813|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567814|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567815|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567816|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567818|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567819|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
567820|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567821|NCT00908882|E2|Reported Event|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke received standard of care for smoking cessation and use the standard PTSD Health Buddy
567822|NCT00908882|E1|Reported Event|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke are exposed to an intervention which included a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care
Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
567823|NCT00908895|B3|Baseline|Total|Total of all reporting groups
567824|NCT00908895|B2|Baseline|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
567825|NCT00908895|B1|Baseline|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
567826|NCT00908895|P2|Participant Flow|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
567827|NCT00908895|P1|Participant Flow|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
567828|NCT00908895|O2|Outcome|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
567829|NCT00908895|O1|Outcome|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
567830|NCT00908895|O2|Outcome|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
567831|NCT00908895|O1|Outcome|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
567832|NCT00908895|E2|Reported Event|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
567833|NCT00908895|E1|Reported Event|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
567834|NCT00908908|B1|Baseline|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
567835|NCT00908908|P1|Participant Flow|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
567836|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
567837|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
567838|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
567839|NCT00908908|E1|Reported Event|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
567840|NCT00908960|B4|Baseline|Total|Total of all reporting groups
567841|NCT00908960|B3|Baseline|Arm C (Low TFMP)|Observation
567842|NCT00908960|B2|Baseline|Arm B (High TFMP)|Observation
567843|NCT00908960|B1|Baseline|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
567844|NCT00908960|P3|Participant Flow|Arm C (Low TFMP)|Observation
567845|NCT00908960|P2|Participant Flow|Arm B (High TFMP)|Observation
567846|NCT00908960|P1|Participant Flow|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
567847|NCT00908960|O3|Outcome|Arm C (Low TFMP)|Observation
567848|NCT00908960|O2|Outcome|Arm B (High TFMP)|Observation
567849|NCT00908960|O1|Outcome|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
567850|NCT00908960|E3|Reported Event|Arm C (Low TFMP)|Observation
567851|NCT00908960|E2|Reported Event|Arm B (High TFMP)|Observation
567852|NCT00908960|E1|Reported Event|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
567853|NCT00909038|B1|Baseline|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
567854|NCT00909038|P1|Participant Flow|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
567855|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
567856|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
567857|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
567858|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
567859|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
572645|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
567861|NCT00909038|E1|Reported Event|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
567862|NCT00909064|B1|Baseline|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement
Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
567863|NCT00909064|P1|Participant Flow|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement
Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
567864|NCT00909064|O1|Outcome|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement
Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
567865|NCT00909064|O1|Outcome|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement
Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
567866|NCT00909064|O1|Outcome|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement
Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
567867|NCT00909064|E1|Reported Event|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement
Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
567868|NCT00909155|B4|Baseline|Total|Total of all reporting groups
567869|NCT00909155|B3|Baseline|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
567870|NCT00909155|B2|Baseline|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine
Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
567871|NCT00909155|B1|Baseline|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT
Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
567872|NCT00909155|P3|Participant Flow|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
567873|NCT00909155|P2|Participant Flow|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine
Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
567874|NCT00909155|P1|Participant Flow|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT).
Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
567875|NCT00909155|O3|Outcome|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
567876|NCT00909155|O2|Outcome|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine
Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
567877|NCT00909155|O1|Outcome|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT
Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
567878|NCT00909155|E3|Reported Event|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
567879|NCT00909155|E2|Reported Event|Currently Depressed Subjects; Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine
Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
567880|NCT00909155|E1|Reported Event|Currently Depressed Subjects; Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT.
Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
567881|NCT00909181|B4|Baseline|Total|Total of all reporting groups
567882|NCT00909181|B3|Baseline|Placebo Gel|
567883|NCT00909181|B2|Baseline|Oxybutynin Gel 84 mg/Day|
567884|NCT00909181|B1|Baseline|Oxybutynin Gel 56 mg/Day|
567885|NCT00909181|P3|Participant Flow|Placebo Gel|
567886|NCT00909181|P2|Participant Flow|Oxybutynin Gel 84 mg/Day|
567887|NCT00909181|P1|Participant Flow|Oxybutynin Gel 56 mg/Day|
567888|NCT00909181|O3|Outcome|Placebo Gel|
567889|NCT00909181|O2|Outcome|Oxybutynin Gel 84 mg/Day|
567890|NCT00909181|O1|Outcome|Oxybutynin Gel 56 mg/Day|
567891|NCT00909181|E3|Reported Event|Placebo Gel|
567892|NCT00909181|E2|Reported Event|Oxybutynin Gel 84 mg/Day|
567893|NCT00909181|E1|Reported Event|Oxybutynin Gel 56 mg/Day|
567895|NCT00909324|B2|Baseline|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
567896|NCT00909324|B1|Baseline|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
567897|NCT00909324|P2|Participant Flow|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
567898|NCT00909324|P1|Participant Flow|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
567899|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
567900|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
567901|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
567902|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
567903|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
567904|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
567905|NCT00909324|E2|Reported Event|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
567906|NCT00909324|E1|Reported Event|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
567907|NCT00909389|B1|Baseline|Filipino Patients With Hypercholesterolemia|
567908|NCT00909389|P1|Participant Flow|Filipino Patients With Hypercholesterolemia|
567909|NCT00909389|O1|Outcome|Filipino Patients With Hypercholesterolemia|
567910|NCT00909389|E1|Reported Event|Filipino Patients With Hypercholesterolemia|
567911|NCT00909428|B4|Baseline|Total|Total of all reporting groups
567912|NCT00909428|B3|Baseline|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
567913|NCT00909428|B2|Baseline|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
567914|NCT00909428|B1|Baseline|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI)
567915|NCT00909428|P3|Participant Flow|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
567916|NCT00909428|P2|Participant Flow|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
567917|NCT00909428|P1|Participant Flow|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI).
567918|NCT00909428|O2|Outcome|One Month Maximal Cystometric Capacity|All patients with DOI or USI had their maximal cystometric capacity recorded following 30 days of treatment with daily 10mg solifenacin succinate.
567919|NCT00909428|O1|Outcome|Baseline Maximal Cystometric Capacity|All patients with DOI or USI had their baseline maximal cystometric capacity recorded
567920|NCT00909428|E3|Reported Event|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
567921|NCT00909428|E2|Reported Event|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
567922|NCT00909428|E1|Reported Event|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI)
567923|NCT00909480|B3|Baseline|Total|Total of all reporting groups
567924|NCT00909480|B2|Baseline|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567925|NCT00909480|B1|Baseline|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567926|NCT00909480|P2|Participant Flow|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567927|NCT00909480|P1|Participant Flow|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567928|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567929|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567930|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567931|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567932|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567933|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567934|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567935|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567936|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567937|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
572646|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
567940|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567941|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567942|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567943|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567944|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567945|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567946|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567947|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567948|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567949|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567950|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567951|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567952|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567953|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567954|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567955|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567956|NCT00909480|E2|Reported Event|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
567957|NCT00909480|E1|Reported Event|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
567958|NCT00909532|B3|Baseline|Total|Total of all reporting groups
567959|NCT00909532|B2|Baseline|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
567960|NCT00909532|B1|Baseline|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
567961|NCT00909532|P2|Participant Flow|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
567962|NCT00909532|P1|Participant Flow|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
567963|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
567964|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
567965|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
567966|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
567967|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
567968|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
567969|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
567970|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
567971|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablets of 150 mg of ivacaftor q12h for up to 48 weeks.
567972|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
567973|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
567974|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
567975|NCT00909532|E2|Reported Event|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
567976|NCT00909532|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
567977|NCT00909545|B5|Baseline|Total|Total of all reporting groups
567978|NCT00909545|B4|Baseline|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
567979|NCT00909545|B3|Baseline|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
567980|NCT00909545|B2|Baseline|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
567981|NCT00909545|B1|Baseline|Placebo|4 Placebo to Match (PTM) tablets once daily
567982|NCT00909545|P4|Participant Flow|Isradipine CR 15-20mg/Day|3-4 Dynacirc CR 5mg tablets once daily
567983|NCT00909545|P3|Participant Flow|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
567984|NCT00909545|P2|Participant Flow|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
567985|NCT00909545|P1|Participant Flow|Placebo|4 Placebo to Match (PTM) tablets once daily
567986|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
567987|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
567988|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
567989|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
567990|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
567991|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
567992|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
567993|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
567994|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
567995|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
567996|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
567997|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
567998|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
567999|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
572647|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
568003|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568004|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568005|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568006|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568007|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568008|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568009|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568010|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568011|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568012|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568013|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568014|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568015|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568016|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568017|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568018|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568019|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568020|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568021|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568022|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568023|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568024|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568025|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568026|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568027|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568028|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568029|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568030|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568031|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568032|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568033|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568034|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568035|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568036|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568037|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568038|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568039|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568040|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568041|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568042|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568043|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568044|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568045|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568046|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568047|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568048|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568049|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568050|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568051|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568052|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568053|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568054|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568055|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568056|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568057|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568058|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568059|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568060|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568061|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568062|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568063|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568064|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568065|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568066|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568067|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568070|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568071|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568072|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568073|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568074|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568075|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568076|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568077|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568078|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568079|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568080|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568081|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568082|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568083|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568084|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568085|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568086|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568087|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568088|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568089|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568090|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568091|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568092|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568093|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568094|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568095|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568096|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568097|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568098|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568099|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568100|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568101|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568102|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568103|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568104|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568105|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568106|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568107|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568108|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568109|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568110|NCT00909545|O4|Outcome|Isradipine CR 15-20mg/Day|3-4 Dynacirc CR 5mg tablets once daily
568111|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568112|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568113|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
568114|NCT00909545|E4|Reported Event|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
568115|NCT00909545|E3|Reported Event|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
568116|NCT00909545|E2|Reported Event|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
568117|NCT00909545|E1|Reported Event|Placebo|4 Placebo to Match (PTM) tablets once daily
568118|NCT00909610|B3|Baseline|Total|Total of all reporting groups
568119|NCT00909610|B2|Baseline|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
568120|NCT00909610|B1|Baseline|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.
568121|NCT00909610|P2|Participant Flow|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
568122|NCT00909610|P1|Participant Flow|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.
568123|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
568124|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
568125|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
568126|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
568127|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
568128|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
568129|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
568130|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
568131|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
568132|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
568133|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
568134|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
568135|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
568136|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
568137|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
568138|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period
568139|NCT00909649|B3|Baseline|Total|Total of all reporting groups
568140|NCT00909649|B2|Baseline|Non Fibrin Group|
568141|NCT00909649|B1|Baseline|Fibrin Group|
568142|NCT00909649|P2|Participant Flow|Non Fibrin Group|
568143|NCT00909649|P1|Participant Flow|Fibrin Group|
568144|NCT00909649|O2|Outcome|Non Fibrin Group|
568145|NCT00909649|O1|Outcome|Fibrin Group|
568146|NCT00909727|B3|Baseline|Total|Total of all reporting groups
568147|NCT00909727|B2|Baseline|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
568148|NCT00909727|B1|Baseline|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
568149|NCT00909727|P2|Participant Flow|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
568150|NCT00909727|P1|Participant Flow|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
568151|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
568152|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
568153|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
568154|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
568155|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
568156|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
568157|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
568158|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
568159|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
568160|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
568161|NCT00909727|E2|Reported Event|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
568162|NCT00909727|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
568163|NCT00909753|B3|Baseline|Total|Total of all reporting groups
568164|NCT00909753|B2|Baseline|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
568165|NCT00909753|B1|Baseline|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
568166|NCT00909753|P2|Participant Flow|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
568167|NCT00909753|P1|Participant Flow|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
568168|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
568169|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
568170|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
568171|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
568172|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
568173|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
568174|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
568175|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
568176|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
568177|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
568178|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
568179|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
568180|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
568181|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
568182|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
568183|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
568184|NCT00909779|B3|Baseline|Total|Total of all reporting groups
568185|NCT00909779|B2|Baseline|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568186|NCT00909779|B1|Baseline|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568187|NCT00909779|P2|Participant Flow|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568188|NCT00909779|P1|Participant Flow|Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568647|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
568189|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568190|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
568191|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568192|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
568193|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568194|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
568195|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568196|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
568197|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568198|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
568199|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568200|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
568201|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568202|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
568203|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568204|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
568205|NCT00909779|O2|Outcome|Placebo|Placebo twice daily
568206|NCT00909779|O1|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568207|NCT00909779|E2|Reported Event|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568208|NCT00909779|E1|Reported Event|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
568209|NCT00909792|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
568210|NCT00909792|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A multifocal contact lenses worn first, with Lotrafilcon B multifocal contact lenses worn second. Both products worn in a daily wear basis.
568211|NCT00909792|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B multifocal contact lenses worn first, with Senofilcon A multifocal contact lenses worn second. Both products worn in a daily wear basis.
568212|NCT00909792|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
568213|NCT00909792|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
568214|NCT00909792|E2|Reported Event|Senofilcon A|Silicone hydrogel, soft, multifocal contact lens
568215|NCT00909792|E1|Reported Event|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens
568216|NCT00909844|B1|Baseline|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
568217|NCT00909844|P1|Participant Flow|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
568429|NCT00901901|B2|Baseline|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
568218|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568219|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568220|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568221|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568222|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568223|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568224|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568225|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568226|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568227|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568228|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568229|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568230|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568231|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
568232|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
568233|NCT00909844|E1|Reported Event|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
568234|NCT00909857|B3|Baseline|Total|Total of all reporting groups
568235|NCT00909857|B2|Baseline|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568236|NCT00909857|B1|Baseline|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568237|NCT00909857|P2|Participant Flow|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568238|NCT00909857|P1|Participant Flow|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568239|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568240|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568241|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568242|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568243|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568244|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568245|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568246|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568247|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568248|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568249|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568250|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568251|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568252|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568253|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568254|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568255|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568256|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568257|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568258|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568259|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568260|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568261|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568262|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568263|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568264|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568265|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568266|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568267|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568268|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568269|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568270|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568271|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568272|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568273|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568274|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568275|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568276|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568277|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568278|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568279|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568430|NCT00901901|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
568280|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568281|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568282|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568283|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568284|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568285|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568286|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568287|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568288|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568289|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568290|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568291|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568292|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568293|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568294|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568295|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568296|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568297|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568298|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568299|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568300|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568301|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568302|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568303|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568304|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568305|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568306|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568307|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568308|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568309|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568431|NCT00901901|P2|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
568310|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568311|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568312|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568313|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568314|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568315|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568316|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568317|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568318|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568319|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568320|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568321|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568322|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568323|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568324|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568325|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568326|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568327|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568328|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568329|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568330|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568331|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568332|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568333|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568334|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568335|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568336|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568337|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568338|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568339|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568432|NCT00901901|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
568340|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568341|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568342|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568343|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568344|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568345|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568346|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568347|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568348|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568349|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568350|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568351|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568352|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568353|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568354|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568355|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568356|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568357|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568358|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568359|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568360|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568361|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568362|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568363|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568364|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568365|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568366|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568367|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568368|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568369|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568433|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
568370|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568371|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568372|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568373|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568374|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568375|NCT00909857|E2|Reported Event|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
568376|NCT00909857|E1|Reported Event|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
568377|NCT00909870|B3|Baseline|Total|Total of all reporting groups
568378|NCT00909870|B2|Baseline|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
568379|NCT00909870|B1|Baseline|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
568380|NCT00909870|P2|Participant Flow|Active Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
568381|NCT00909870|P1|Participant Flow|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
568382|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
568383|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
568384|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
568385|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of=- Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
568386|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
568387|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
568388|NCT00909870|E2|Reported Event|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
568389|NCT00909870|E1|Reported Event|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
568390|NCT00910000|B7|Baseline|Total|Total of all reporting groups
568391|NCT00910000|B6|Baseline|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568392|NCT00910000|B5|Baseline|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568393|NCT00910000|B4|Baseline|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568394|NCT00910000|B3|Baseline|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568395|NCT00910000|B2|Baseline|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568396|NCT00910000|B1|Baseline|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568434|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
569183|NCT00914810|B1|Baseline|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
568397|NCT00910000|P6|Participant Flow|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568398|NCT00910000|P5|Participant Flow|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568399|NCT00910000|P4|Participant Flow|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568400|NCT00910000|P3|Participant Flow|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568401|NCT00910000|P2|Participant Flow|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568402|NCT00910000|P1|Participant Flow|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568403|NCT00910000|O6|Outcome|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568404|NCT00910000|O5|Outcome|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568405|NCT00910000|O4|Outcome|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568406|NCT00910000|O3|Outcome|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568407|NCT00910000|O2|Outcome|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568408|NCT00910000|O1|Outcome|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568409|NCT00910000|O6|Outcome|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568410|NCT00910000|O5|Outcome|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568411|NCT00910000|O4|Outcome|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568435|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
568700|NCT00910273|B2|Baseline|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568412|NCT00910000|O3|Outcome|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568413|NCT00910000|O2|Outcome|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568414|NCT00910000|O1|Outcome|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle
Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle
Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568415|NCT00910000|O1|Outcome|All Phase Ib Participants|"All Phase Ib participants received Vorinostat according to the established dose escalation schedule during a 3-week cycle in combination with IV carboplatin AUC 4 (day 2) and IV gemcitabine 1000 mg/m2 (days 2 and 9).
Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
568416|NCT00910000|E1|Reported Event|All Phase Ib Participants|All Phase Ib participants received Vorinostat according to the established dose escalation schedule during a 3-week cycle in combination with IV carboplatin AUC 4 (day 2) and IV gemcitabine 1000 mg/m2 (days 2 and 9). Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
568417|NCT00910039|B1|Baseline|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
568418|NCT00910039|P1|Participant Flow|Sunitinib Malate|"Oral sunitinib malate (37.5mg) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
568419|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
568420|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
568421|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
568422|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
568423|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
568424|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
568425|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
568426|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
568427|NCT00910039|E1|Reported Event|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
568428|NCT00901901|B3|Baseline|Total|Total of all reporting groups
568750|NCT00910273|E2|Reported Event|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568436|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
568437|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
568438|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
568439|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
568440|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
568441|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
568442|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
568443|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
568444|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
568445|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
568446|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
568447|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
568448|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
568449|NCT00901901|E2|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
568450|NCT00901901|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
568451|NCT00902161|B3|Baseline|Total|Total of all reporting groups
568452|NCT00902161|B2|Baseline|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568453|NCT00902161|B1|Baseline|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568454|NCT00902161|P3|Participant Flow|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week run-on before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranol titration through Visit 8 clamp procedures).
568455|NCT00902161|P2|Participant Flow|Propanolol + Placebo / Propanolol + MK0893|After a 4 week wash-out period with a 4-week propanolol run-on, MK0893-matched placebo was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8) while continuing on propanolol.
568456|NCT00902161|P1|Participant Flow|Propanolol + MK0893 / Propanolol + Placebo|After a 4 week wash-out period with a 4-week propanolol run-on, single dose MK0893 was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8) while continuing on propanolol.
568457|NCT00902161|O3|Outcome|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
568458|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568459|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568460|NCT00902161|O3|Outcome|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
568461|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568462|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568463|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568464|NCT00902161|O1|Outcome|MK0893|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568465|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568466|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568529|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568467|NCT00902161|E3|Reported Event|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
568468|NCT00902161|E2|Reported Event|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568469|NCT00902161|E1|Reported Event|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
568470|NCT00902174|B3|Baseline|Total|Total of all reporting groups
568471|NCT00902174|B2|Baseline|Placebo|Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
568472|NCT00902174|B1|Baseline|Imatinib Mesylate|Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
568473|NCT00902174|P2|Participant Flow|Placebo|Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
568474|NCT00902174|P1|Participant Flow|Imatinib Mesylate|Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
568475|NCT00902174|O2|Outcome|GCP74588|imatinib metabolite
568476|NCT00902174|O1|Outcome|Imatinib 400 mg|imatinib mesylate 400 mg once daily
568477|NCT00902174|O2|Outcome|GCP74588|imatinib metabolite
568478|NCT00902174|O1|Outcome|Imatinib 200 mg|imatinib mesylate 200 mg once daily
568479|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568480|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568481|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568482|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568483|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568484|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568485|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568486|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568487|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568488|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568489|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568490|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568491|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568492|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568493|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568494|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568495|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568496|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568497|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568498|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568499|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568500|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568501|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568502|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568503|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568504|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568505|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
568506|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
568507|NCT00902174|E2|Reported Event|Placebo|Placebo to imatinib
568508|NCT00902174|E1|Reported Event|Imatinib|imatinib mesylate
568509|NCT00902226|B1|Baseline|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568510|NCT00902226|P1|Participant Flow|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568511|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568512|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568513|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568514|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568515|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568516|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568517|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568518|NCT00902226|E1|Reported Event|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568519|NCT00902265|B1|Baseline|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568520|NCT00902265|P1|Participant Flow|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568521|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568522|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568523|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568524|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568525|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568526|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568527|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568528|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568530|NCT00902265|E1|Reported Event|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription."
568531|NCT00902304|B4|Baseline|Total|Total of all reporting groups
568532|NCT00902304|B3|Baseline|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568533|NCT00902304|B2|Baseline|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568534|NCT00902304|B1|Baseline|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568535|NCT00902304|P3|Participant Flow|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568536|NCT00902304|P2|Participant Flow|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568537|NCT00902304|P1|Participant Flow|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568538|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568539|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568540|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568541|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568542|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568543|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568544|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568545|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568546|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568547|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568548|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568549|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568550|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568551|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568552|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568553|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568554|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568555|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568556|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568557|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568558|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568559|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568560|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568561|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568645|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
568562|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568563|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568564|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568565|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568566|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568567|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568568|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568569|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568570|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568571|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568572|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568573|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568574|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568575|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568576|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568646|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
568577|NCT00902304|E4|Reported Event|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568578|NCT00902304|E3|Reported Event|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
568579|NCT00902304|E2|Reported Event|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
568580|NCT00902304|E1|Reported Event|Pre-randomization|Pre-randomization
568581|NCT00902330|B3|Baseline|Total|Total of all reporting groups
568582|NCT00902330|B2|Baseline|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.
sham intervention: Given once a day for 18 weeks"
568583|NCT00902330|B1|Baseline|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.
energy-based therapy: Given once a day for 18 weeks"
568584|NCT00902330|P2|Participant Flow|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.
sham intervention: Given once a day for 18 weeks"
568585|NCT00902330|P1|Participant Flow|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.
energy-based therapy: Given once a day for 18 weeks"
568586|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
568587|NCT00902330|O2|Outcome|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.
sham intervention: Given once a day for 18 weeks"
568588|NCT00902330|O1|Outcome|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.
energy-based therapy: Given once a day for 18 weeks"
568589|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
568590|NCT00902330|O2|Outcome|Arm II|Sham CES
568591|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
568592|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
568593|NCT00902330|O2|Outcome|Arm II|Sham CES
568594|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
568595|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
568596|NCT00902330|O2|Outcome|Arm II|Sham CES
568597|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
568598|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
568599|NCT00902330|O2|Outcome|Arm II|Sham CES
568600|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
568601|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
568602|NCT00902330|O2|Outcome|Arm II|Sham CES
568603|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
568604|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
568605|NCT00902330|O2|Outcome|Arm II|Sham CES
568606|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
568607|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
568608|NCT00902330|O2|Outcome|Arm II|Sham CES
568609|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
568610|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
568611|NCT00902330|O2|Outcome|Arm II|Sham CES
568612|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
568613|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
568614|NCT00902330|O2|Outcome|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.
sham intervention: Given once a day for 18 weeks"
568615|NCT00902330|O1|Outcome|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.
energy-based therapy: Given once a day for 18 weeks"
568616|NCT00902330|E2|Reported Event|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.
sham intervention: Given once a day for 18 weeks"
569184|NCT00914810|P2|Participant Flow|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
568617|NCT00902330|E1|Reported Event|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.
energy-based therapy: Given once a day for 18 weeks"
568618|NCT00902538|B4|Baseline|Total|Total of all reporting groups
568619|NCT00902538|B3|Baseline|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
568620|NCT00902538|B2|Baseline|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3
568621|NCT00902538|B1|Baseline|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
568622|NCT00902538|P6|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 oral tablets, given once daily, in double-blind, randomized, Period 4
568623|NCT00902538|P5|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets, given once daily, in double-blind, randomized, Period 4.
568624|NCT00902538|P4|Participant Flow|OLM 40-AML 10-HCTZ 12.5 (Responders)|Participants who meet their blood pressure goals (responded) in Period 3 and continued into 8-week, double-blind Period 4 continued to receive OLM 40-AML 10-HCTZ 12.5 oral tablets given once daily.
568625|NCT00902538|P3|Participant Flow|OLM 40-AML 10-HCTZ 25|Participants could start receiving OLM 40-AML 10-HCTZ 25 oral tablets, given once daily, in randomized, double-blind, 8- week Period 2.
568626|NCT00902538|P2|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets given once daily in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
568627|NCT00902538|P1|Participant Flow|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received Olmesartan(OLM) 40 mg-Amlodipine(AML) 10 mg oral tablets, once a day, for the 8-week, single-blind, run-in Period 1. Then in Period 2, participants would be randomized to this same combination or have hydrochlorothiazide oral tablets (12.5 or 25 mg) added for an additional 8 weeks. All medication is given once a day.
568628|NCT00902538|O2|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
568629|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
568630|NCT00902538|O2|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
568631|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
568632|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
568633|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
568634|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
568635|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
568636|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
568637|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
568638|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
568639|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
568640|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
568641|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
568642|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
568643|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
568644|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
568648|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
568649|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
568650|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
568651|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
568652|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
568653|NCT00902538|E3|Reported Event|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
568654|NCT00902538|E2|Reported Event|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
568655|NCT00902538|E1|Reported Event|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
568656|NCT00902564|B1|Baseline|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568657|NCT00902564|P1|Participant Flow|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568658|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568659|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568660|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568661|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568662|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568663|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568664|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568665|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568666|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568667|NCT00902564|E1|Reported Event|Escitalopram (5 to 20 mg Oral Tablets Daily)|
568668|NCT00910091|B3|Baseline|Total|Total of all reporting groups
568669|NCT00910091|B2|Baseline|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568670|NCT00910091|B1|Baseline|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568671|NCT00910091|P2|Participant Flow|Arm B: MA 160 mg|Megestrol Acetate (MA) 160 mg tablet by mouth once daily
568672|NCT00910091|P1|Participant Flow|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568673|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568674|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568675|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568676|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568677|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568678|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568679|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568680|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568681|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568682|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568683|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568684|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568685|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568686|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568687|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568688|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568689|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568690|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568691|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568692|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568693|NCT00910091|O2|Outcome|Arm B: MA 160 mg|Megestrol Acetate (MA) 160 mg tablet by mouth once daily
568694|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568695|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
568696|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
568697|NCT00910091|E2|Reported Event|B- MA - 160mg|"After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service
Megestrol Acetate (MA): MA will be administered orally as 160mg daily"
568698|NCT00910091|E1|Reported Event|A- BN 83495- 40mg|"After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service
BN83495: BN83495 will be administered as a 40 mg tablet once a day orally"
568699|NCT00910273|B3|Baseline|Total|Total of all reporting groups
572648|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
568701|NCT00910273|B1|Baseline|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568702|NCT00910273|P2|Participant Flow|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568703|NCT00910273|P1|Participant Flow|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568704|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568705|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568706|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568707|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568708|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568709|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568710|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568711|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568712|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568713|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568714|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568715|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568716|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568717|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568718|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568719|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568720|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568721|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568722|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568723|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568724|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568725|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568726|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568727|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568728|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568729|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568730|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568731|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568732|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568733|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568734|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568735|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568736|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568737|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568738|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568739|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568740|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568741|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568742|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568743|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568744|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568745|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568746|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568747|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568748|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
568749|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
572649|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
568751|NCT00910273|E1|Reported Event|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
568752|NCT00910299|B3|Baseline|Total|Total of all reporting groups
568753|NCT00910299|B2|Baseline|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
568754|NCT00910299|B1|Baseline|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
568755|NCT00910299|P2|Participant Flow|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
568756|NCT00910299|P1|Participant Flow|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
568757|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
568758|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
568759|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
568760|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
568761|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
568762|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
568763|NCT00910299|E2|Reported Event|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
568764|NCT00910299|E1|Reported Event|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
568765|NCT00913003|B3|Baseline|Total|Total of all reporting groups
568766|NCT00913003|B2|Baseline|Lidocaine|"Group A lidocaine infusion and bolus.
Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
568767|NCT00913003|B1|Baseline|Placebo|"Group B using saline as a placebo.
Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
568768|NCT00913003|P2|Participant Flow|Lidocaine|"Group A lidocaine infusion and bolus.
Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
568769|NCT00913003|P1|Participant Flow|Placebo|"Group B using saline as a placebo.
Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
568770|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.
Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
568771|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.
Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
568772|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.
Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
568773|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.
Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
568774|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.
Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
568775|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.
Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
568776|NCT00913003|E2|Reported Event|Lidocaine|"Group A lidocaine infusion and bolus.
Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
568777|NCT00913003|E1|Reported Event|Placebo|"Group B using saline as a placebo.
Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
568778|NCT00913081|B1|Baseline|All Study Participants|Participants received one dose of Quercetin 500 mg, Quercetin 1000 mg, Quercetin 2000 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
568779|NCT00913081|P1|Participant Flow|All Study Participants|Participants received one dose of Quercetin 500 mg, Quercetin 100 mg, Quercetin 200 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and pharmacodymic assessments for 8 hours after Quercetin dosing. Each participant then crossed over to one of the remaining dose group/placebo in a randomized, double blind fashion after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
568780|NCT00913081|O4|Outcome|Placebo|Participants received placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
568781|NCT00913081|O3|Outcome|Quercetin 2000 mg|Participants received one dose of Quercetin 2000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
568782|NCT00913081|O2|Outcome|Quercetin 1000 mg|Participants received one dose of Quercetin 1000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
568968|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
572650|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
568783|NCT00913081|O1|Outcome|Quercetin 500 mg|Participants received one dose of Quercetin 500 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
568784|NCT00913081|E4|Reported Event|Placebo|Participants received placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
568785|NCT00913081|E3|Reported Event|Quercetin 2000 mg|Participants received one dose of Quercetin 2000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
568786|NCT00913081|E2|Reported Event|Quercetin 1000 mg|Participants received one dose of Quercetin 1000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
568787|NCT00913081|E1|Reported Event|Quercetin 500 mg|Participants received one dose of Quercetin 500 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
568788|NCT00913133|B1|Baseline|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
568789|NCT00913133|P1|Participant Flow|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
568790|NCT00913133|O1|Outcome|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
568791|NCT00913133|O1|Outcome|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
568792|NCT00913133|E1|Reported Event|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
568793|NCT00913263|B1|Baseline|Group 1|Men with histologically confirmed localized prostate cancer (T1–T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
568794|NCT00913263|P1|Participant Flow|Hydroxyflutamide (2-HOF)|Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
568795|NCT00913263|O1|Outcome|Part 1|Patients (24 patients) have been injected with Liproca depot once
568796|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once.
568797|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once.
568798|NCT00913263|O1|Outcome|Part I|Patients (24 patients) in Part I have been injected with Liproca Depot once.
568799|NCT00913263|O1|Outcome|Group 1|24 patients (Part I of the study) have been injected with Liproca Depot once.
568800|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
568801|NCT00913263|E1|Reported Event|Group 1|Men with histologically confirmed localized prostate cancer (T1–T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
568802|NCT00913380|B3|Baseline|Total|Total of all reporting groups
568803|NCT00913380|B2|Baseline|Standard-dose CT|Aimed to 8 mSv in an average patient
568804|NCT00913380|B1|Baseline|Low-dose CT|Aimed to 2 mSv in an average patient
568805|NCT00913380|P2|Participant Flow|Standard-dose CT|Aimed to 8 mSv in an average patient
568806|NCT00913380|P1|Participant Flow|Low-dose CT|Aimed to 2 mSv in an average patient
568807|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
568808|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
568809|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
568810|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
568811|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
568812|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
568813|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
568814|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
568815|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
568816|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
568817|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
568818|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
568819|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
568820|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
568821|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
568822|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
568823|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
568824|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
568825|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
568826|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
568827|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
568828|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
568829|NCT00913380|E2|Reported Event|Standard-dose CT|Aimed to 8 mSv in an average patient
568830|NCT00913380|E1|Reported Event|Low-dose CT|Aimed to 2 mSv in an average patient
569178|NCT00914589|E3|Reported Event|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
568831|NCT00913458|B1|Baseline|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568832|NCT00913458|P7|Participant Flow|Placebo (PBO) (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
568833|NCT00913458|P6|Participant Flow|MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
568834|NCT00913458|P5|Participant Flow|E25+MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
568835|NCT00913458|P4|Participant Flow|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
568836|NCT00913458|P3|Participant Flow|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568837|NCT00913458|P2|Participant Flow|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568838|NCT00913458|P1|Participant Flow|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568839|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
568840|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568841|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
569185|NCT00914810|P1|Participant Flow|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
569186|NCT00914810|O2|Outcome|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
568842|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568843|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568844|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568845|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
568846|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568847|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568848|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568849|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568969|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
572651|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
568850|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568851|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
568852|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568853|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568854|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568855|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568856|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568857|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
568909|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
572652|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
568858|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568859|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568860|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568861|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568862|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568863|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
568864|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568865|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568966|NCT00913692|P1|Participant Flow|Glutamine (Study Agent) or Glycine (Placebo)|Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
568866|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568867|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568868|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568869|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568870|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568871|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568872|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568873|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568967|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
572653|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
568874|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568875|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568876|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568877|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568878|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568879|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568880|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568881|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe.All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568910|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
572654|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
568882|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568883|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568884|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568885|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568886|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568887|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568888|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568889|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568911|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568890|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568891|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568892|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568893|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568894|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568895|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568896|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568897|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568957|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
568958|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
568959|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
568898|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568899|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568900|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
568901|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568902|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568903|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568904|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568905|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568906|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568907|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568908|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568960|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
568961|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
568962|NCT00913523|E3|Reported Event|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
568912|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568913|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568914|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568915|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568916|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568917|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568918|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
568919|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568920|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
568921|NCT00913458|E7|Reported Event|Placebo (PBO) (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
568922|NCT00913458|E6|Reported Event|MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
568923|NCT00913458|E5|Reported Event|E25+MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
568963|NCT00913523|E2|Reported Event|Tampon Without GML|Regular and Super Tampon without GML added to the cover
568964|NCT00913523|E1|Reported Event|Tampon With GML|Regular and Super Tampon with GML added to the cover
568965|NCT00913692|B1|Baseline|Glutamine (Study Agent) or Glycine (Placebo)|Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
572655|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
568924|NCT00913458|E4|Reported Event|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.
Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
568925|NCT00913458|E3|Reported Event|MTX + PBO (Phase 2)|"In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.
Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.
The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.
Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
568926|NCT00913458|E2|Reported Event|E25 + MTX (Phase 2)|"In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.
The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.
Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
568927|NCT00913458|E1|Reported Event|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
568928|NCT00913510|B3|Baseline|Total|Total of all reporting groups
568929|NCT00913510|B2|Baseline|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
568930|NCT00913510|B1|Baseline|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
568931|NCT00913510|P2|Participant Flow|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start.
568932|NCT00913510|P1|Participant Flow|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start and start of CIC using LoFric Primo catheters.
568933|NCT00913510|O2|Outcome|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
568934|NCT00913510|O1|Outcome|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
568935|NCT00913510|E2|Reported Event|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
568936|NCT00913510|E1|Reported Event|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
568937|NCT00913523|B4|Baseline|Total|Total of all reporting groups
568938|NCT00913523|B3|Baseline|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
568939|NCT00913523|B2|Baseline|Tampon Without GML|Regular and Super Tampon without GML added to the cover
568940|NCT00913523|B1|Baseline|Tampon With GML|Regular and Super Tampon with GML added to the cover
568941|NCT00913523|P3|Participant Flow|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
568942|NCT00913523|P2|Participant Flow|Tampon Without GML|Regular and Super Tampon without GML added to the cover
568943|NCT00913523|P1|Participant Flow|Tampon With GML|Regular and Super Tampon with GML added to the cover
568944|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
568945|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
568946|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
568947|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
568948|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
568949|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
568950|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
568951|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
568952|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
568953|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
568954|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
568955|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
568956|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
572656|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
568970|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
568971|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the primary outcome could not be measured and analyzed.
568972|NCT00913692|E3|Reported Event|Treatment Phase 2|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
568973|NCT00913692|E2|Reported Event|Washout|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
568974|NCT00913692|E1|Reported Event|Treatment Phase 1|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
568975|NCT00913744|B3|Baseline|Total|Total of all reporting groups
568976|NCT00913744|B2|Baseline|Sham|Sham injection
568977|NCT00913744|B1|Baseline|Ocriplasmin|Intravitreal injection (125 µg)
568978|NCT00913744|P2|Participant Flow|Sham|Sham injection
568979|NCT00913744|P1|Participant Flow|Ocriplasmin|Intravitreal injection (125 µg)
568980|NCT00913744|O2|Outcome|Sham|Sham injection
568981|NCT00913744|O1|Outcome|Ocriplasmin|Intravitreal injection (125 µg)
568982|NCT00913744|E2|Reported Event|Sham|Sham injection
568983|NCT00913744|E1|Reported Event|Ocriplasmin|Intravitreal injection (125 µg)
568984|NCT00913770|B4|Baseline|Total|Total of all reporting groups
568985|NCT00913770|B3|Baseline|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation
Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
568986|NCT00913770|B2|Baseline|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment
Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
568987|NCT00913770|B1|Baseline|Standard Care|Standard Care including receiving a referral.
568988|NCT00913770|P3|Participant Flow|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation
Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
568989|NCT00913770|P2|Participant Flow|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment
Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
568990|NCT00913770|P1|Participant Flow|Standard Care|Standard Care including receiving a referral.
568991|NCT00913770|O3|Outcome|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation
Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
568992|NCT00913770|O2|Outcome|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment
Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
568993|NCT00913770|O1|Outcome|Standard Care|Standard Care including receiving a referral.
569011|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569187|NCT00914810|O1|Outcome|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
568994|NCT00913770|O3|Outcome|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation
Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
568995|NCT00913770|O2|Outcome|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment
Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
568996|NCT00913770|O1|Outcome|Standard Care|Standard Care including receiving a referral.
568997|NCT00913770|E3|Reported Event|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation
Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
568998|NCT00913770|E2|Reported Event|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment
Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
568999|NCT00913770|E1|Reported Event|Standard Care|Standard Care including receiving a referral.
569000|NCT00913835|B3|Baseline|Total|Total of all reporting groups
569001|NCT00913835|B2|Baseline|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569002|NCT00913835|B1|Baseline|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569003|NCT00913835|P2|Participant Flow|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there is evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569004|NCT00913835|P1|Participant Flow|Olaratumab + Liposomal Doxorubicin|"20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity.
40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569005|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569006|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569007|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Treatment|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
569008|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569009|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569010|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
569012|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569013|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
569014|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569015|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569016|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
569017|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569018|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569019|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
569020|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569021|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569022|NCT00913835|O1|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
569023|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
569024|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569025|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
569026|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.."
569027|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569028|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569179|NCT00914589|E2|Reported Event|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569029|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569030|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569031|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569032|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569033|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569034|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569035|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569036|NCT00913835|E3|Reported Event|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
569037|NCT00913835|E2|Reported Event|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy."
569038|NCT00913835|E1|Reported Event|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
569039|NCT00913913|B1|Baseline|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)
DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle
Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks
IL-2: IL-2 18 MiU/m2 CI 5 days
IFN: IFN 6 MiU subc TIW"
569040|NCT00913913|P1|Participant Flow|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)
DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle
Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks
IL-2: IL-2 18 MiU/m2 CI 5 days
IFN: IFN 6 MiU subc TIW"
569041|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)
DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle
Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks
IL-2: IL-2 18 MiU/m2 CI 5 days
IFN: IFN 6 MiU subc TIW"
569042|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)
DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle
Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks
IL-2: IL-2 18 MiU/m2 CI 5 days
IFN: IFN 6 MiU subc TIW"
569043|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)
DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle
Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks
IL-2: IL-2 18 MiU/m2 CI 5 days
IFN: IFN 6 MiU subc TIW"
569103|NCT00914316|B4|Baseline|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Placebo: twice daily"
569044|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)
DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle
Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks
IL-2: IL-2 18 MiU/m2 CI 5 days
IFN: IFN 6 MiU subc TIW"
569045|NCT00913913|E1|Reported Event|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)
DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle
Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks
IL-2: IL-2 18 MiU/m2 CI 5 days
IFN: IFN 6 MiU subc TIW"
569046|NCT00914069|B3|Baseline|Total|Total of all reporting groups
569047|NCT00914069|B2|Baseline|Conventional Vascular Access|"Conventional vascular access
Conventional vascular access: Vascular access using conventional venous access device"
569048|NCT00914069|B1|Baseline|RIVS Vascular Access|"RIVS vascular access
RIVS vascular access: Access to peripheral vasculature"
569049|NCT00914069|P2|Participant Flow|Conventional Vascular Access|"Conventional vascular access
Conventional vascular access: Vascular access using conventional venous access device"
569050|NCT00914069|P1|Participant Flow|RIVS Vascular Access|"RIVS vascular access
RIVS vascular access: Access to peripheral vasculature"
569051|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access
Conventional vascular access: Vascular access using conventional venous access device"
569052|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access
RIVS vascular access: Access to peripheral vasculature"
569053|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access
Conventional vascular access: Vascular access using conventional venous access device"
569054|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access
RIVS vascular access: Access to peripheral vasculature"
569055|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access
Conventional vascular access: Vascular access using conventional venous access device"
569056|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access
RIVS vascular access: Access to peripheral vasculature"
569057|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access
Conventional vascular access: Vascular access using conventional venous access device"
569058|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access
RIVS vascular access: Access to peripheral vasculature"
569059|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access
Conventional vascular access: Vascular access using conventional venous access device"
569060|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access
RIVS vascular access: Access to peripheral vasculature"
569061|NCT00914069|E2|Reported Event|Conventional Vascular Access|"Conventional vascular access
Conventional vascular access: Vascular access using conventional venous access device"
569062|NCT00914069|E1|Reported Event|RIVS Vascular Access|"RIVS vascular access
RIVS vascular access: Access to peripheral vasculature"
569063|NCT00914186|B5|Baseline|Total|Total of all reporting groups
569064|NCT00914186|B4|Baseline|TS-022 0.020%|lotion/once daily
569065|NCT00914186|B3|Baseline|TS-022 0.010%|lotion/once daily
569066|NCT00914186|B2|Baseline|TS-022 0.005%|lotion/once daily
569067|NCT00914186|B1|Baseline|Vehicle|once daily
569068|NCT00914186|P4|Participant Flow|TS-022 0.020%|lotion/once daily
569069|NCT00914186|P3|Participant Flow|TS-022 0.010%|lotion/once daily
569070|NCT00914186|P2|Participant Flow|TS-022 0.005%|lotion/once daily
569071|NCT00914186|P1|Participant Flow|Vehicle|once daily
569072|NCT00914186|O2|Outcome|TS-022|lotion/once daily
569073|NCT00914186|O1|Outcome|Vehicle|once daily
569074|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
569075|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
569076|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
569077|NCT00914186|O1|Outcome|Vehicle|once daily
569078|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
569079|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
569080|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
569081|NCT00914186|O1|Outcome|Vehicle|once daily
569082|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
569083|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
569084|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
569085|NCT00914186|O1|Outcome|Vehicle|once daily
569086|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
569087|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
569088|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
569089|NCT00914186|O1|Outcome|Vehicle|once daily
569090|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
569091|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
569092|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
569093|NCT00914186|O1|Outcome|Vehicle|once daily
569094|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
569095|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
569096|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
569097|NCT00914186|O1|Outcome|Vehicle|once daily
569098|NCT00914186|E4|Reported Event|TS-022 0.020%|lotion/once daily
569099|NCT00914186|E3|Reported Event|TS-022 0.010%|lotion/once daily
569100|NCT00914186|E2|Reported Event|TS-022 0.005%|lotion/once daily
569101|NCT00914186|E1|Reported Event|Vehicle|once daily
569102|NCT00914316|B5|Baseline|Total|Total of all reporting groups
569180|NCT00914589|E1|Reported Event|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
569181|NCT00914810|B3|Baseline|Total|Total of all reporting groups
569104|NCT00914316|B3|Baseline|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily"
569105|NCT00914316|B2|Baseline|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily"
569106|NCT00914316|B1|Baseline|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
569107|NCT00914316|P4|Participant Flow|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Placebo: twice daily"
569108|NCT00914316|P3|Participant Flow|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily"
569109|NCT00914316|P2|Participant Flow|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily"
569110|NCT00914316|P1|Participant Flow|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
569111|NCT00914316|O4|Outcome|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Placebo: twice daily"
569112|NCT00914316|O3|Outcome|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily"
569113|NCT00914316|O2|Outcome|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily"
569114|NCT00914316|O1|Outcome|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
569115|NCT00914316|O4|Outcome|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Placebo: twice daily"
569116|NCT00914316|O3|Outcome|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily"
569117|NCT00914316|O2|Outcome|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily"
569118|NCT00914316|O1|Outcome|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
569119|NCT00914316|E4|Reported Event|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Placebo: twice daily"
569120|NCT00914316|E3|Reported Event|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily"
569121|NCT00914316|E2|Reported Event|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily"
569145|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569122|NCT00914316|E1|Reported Event|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
569123|NCT00914459|B3|Baseline|Total|Total of all reporting groups
569124|NCT00914459|B2|Baseline|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569125|NCT00914459|B1|Baseline|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569126|NCT00914459|P2|Participant Flow|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569127|NCT00914459|P1|Participant Flow|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 international units per kilogram [IU/kg] up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the Summary of Product Characteristics (SmPC).
569128|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569129|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569130|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569131|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569132|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569133|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569134|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569135|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569136|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569137|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569138|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569139|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569140|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569141|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569142|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569143|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569144|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged less than or equal to [<=] 12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569182|NCT00914810|B2|Baseline|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
569146|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569147|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569148|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569149|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569150|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569151|NCT00914459|E1|Reported Event|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
569152|NCT00914485|B1|Baseline|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
569153|NCT00914485|P1|Participant Flow|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
569154|NCT00914485|O1|Outcome|Arm 1|"Provider clinical communication training intervention
Provider Communication Skills Training: Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
569155|NCT00914485|E1|Reported Event|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
569156|NCT00914589|B4|Baseline|Total|Total of all reporting groups
569157|NCT00914589|B3|Baseline|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569158|NCT00914589|B2|Baseline|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569159|NCT00914589|B1|Baseline|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
569160|NCT00914589|P3|Participant Flow|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569161|NCT00914589|P2|Participant Flow|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569162|NCT00914589|P1|Participant Flow|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
569163|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569164|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569165|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
569166|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569167|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569168|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
569169|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569170|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569171|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
569172|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569173|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569174|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
569175|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569176|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
569177|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
572657|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
569188|NCT00914810|O2|Outcome|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
569189|NCT00914810|O1|Outcome|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
569190|NCT00914810|E2|Reported Event|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
569191|NCT00914810|E1|Reported Event|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
569192|NCT00914849|B3|Baseline|Total|Total of all reporting groups
569193|NCT00914849|B2|Baseline|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569194|NCT00914849|B1|Baseline|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569195|NCT00914849|P2|Participant Flow|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569196|NCT00914849|P1|Participant Flow|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg intravenous (IV)
Leukopheresis
Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569197|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569198|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569199|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569200|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569201|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569202|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569203|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569204|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569205|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569206|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569207|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569208|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569209|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569210|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569211|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569212|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569213|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569214|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569215|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569216|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569217|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569218|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569219|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569220|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569221|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569222|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569223|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569224|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569225|NCT00914849|E2|Reported Event|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant"
569226|NCT00914849|E1|Reported Event|Arm 1 - Donor|"Day 1
AMD3100 320 ug/kg IV
Leukopheresis
Day 2 (if PBSC collected is not sufficient)
AMD3100 320 ug/kg IV
Leukopheresis"
569227|NCT00914862|B6|Baseline|Total|Total of all reporting groups
569228|NCT00914862|B5|Baseline|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569229|NCT00914862|B4|Baseline|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569230|NCT00914862|B3|Baseline|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569231|NCT00914862|B2|Baseline|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569232|NCT00914862|B1|Baseline|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569233|NCT00914862|P5|Participant Flow|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569234|NCT00914862|P4|Participant Flow|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569235|NCT00914862|P3|Participant Flow|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569236|NCT00914862|P2|Participant Flow|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569237|NCT00914862|P1|Participant Flow|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with Attention Deficit Hyperactivity Disorder (ADHD) received a single 4 mg oral dose of ramelteon.
569238|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569239|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569240|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569241|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569242|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569243|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569244|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569245|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569246|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
572658|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
569247|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569248|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569249|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569250|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569251|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569252|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569253|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569254|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569255|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569256|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569257|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569258|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569259|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569260|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569261|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569262|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569263|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569264|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569265|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569266|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569267|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569268|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569269|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569270|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569271|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569272|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569273|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569274|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569275|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569276|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569277|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569278|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569279|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569280|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569281|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569282|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569283|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569284|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569285|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569286|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569287|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569288|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569289|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569290|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569291|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569292|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569293|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569294|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569295|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569296|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569297|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569298|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569299|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569300|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569301|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569302|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569303|NCT00914862|E5|Reported Event|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
569304|NCT00914862|E4|Reported Event|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
569305|NCT00914862|E3|Reported Event|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
569306|NCT00914862|E2|Reported Event|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
569307|NCT00914862|E1|Reported Event|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
569308|NCT00914966|B1|Baseline|CINRYZE|"There were 3 potential dose escalation steps:
Step 1: 1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks (starting dosing regimen for all subjects in the study)
Step 2: 2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
Step 3: 2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks"
569309|NCT00914966|P1|Participant Flow|CINRYZE|"There were 3 potential dose escalation steps:
Step 1: 1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks (starting dosing regimen for all subjects in the study)
Step 2: 2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
Step 3: 2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks"
569310|NCT00914966|O3|Outcome|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
569311|NCT00914966|O2|Outcome|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
569312|NCT00914966|O1|Outcome|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
569313|NCT00914966|O3|Outcome|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
569314|NCT00914966|O2|Outcome|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
569315|NCT00914966|O1|Outcome|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
569316|NCT00914966|E4|Reported Event|All Subjects|
569317|NCT00914966|E3|Reported Event|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
569318|NCT00914966|E2|Reported Event|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
569319|NCT00914966|E1|Reported Event|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
569320|NCT00915148|B1|Baseline|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.
Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
569321|NCT00915148|P1|Participant Flow|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.
Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
569322|NCT00915148|O1|Outcome|Women Delivered Within 6 Hours|"Nulliparous women, single pregnancy, > 37 weeks of pregnancy, fetus alive and cephalic presentation.
Ultrasound examinations: 2D transperineal scan"
569323|NCT00915148|O1|Outcome|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.
Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
569324|NCT00915148|E1|Reported Event|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.
Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
569325|NCT00915278|B7|Baseline|Total|Total of all reporting groups
569326|NCT00915278|B6|Baseline|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569327|NCT00915278|B5|Baseline|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569536|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569328|NCT00915278|B4|Baseline|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569329|NCT00915278|B3|Baseline|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569330|NCT00915278|B2|Baseline|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569331|NCT00915278|B1|Baseline|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569332|NCT00915278|P6|Participant Flow|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569333|NCT00915278|P5|Participant Flow|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569334|NCT00915278|P4|Participant Flow|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569335|NCT00915278|P3|Participant Flow|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569336|NCT00915278|P2|Participant Flow|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569337|NCT00915278|P1|Participant Flow|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569338|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569339|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569340|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569341|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569342|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569343|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569344|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569345|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569346|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569347|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569348|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569349|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569350|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569689|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
569351|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569352|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569353|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569354|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569355|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569356|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569357|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569358|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569359|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569360|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569361|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569362|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569363|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569364|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569365|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569366|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569367|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569368|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569369|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569370|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569371|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569372|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569373|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
572659|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
569374|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569375|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569376|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569377|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569378|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569379|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569380|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569381|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569382|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569383|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569384|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569385|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569386|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569387|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569388|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569389|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569390|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569391|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569392|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569393|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569394|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569395|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569396|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
572660|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
569397|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569398|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569399|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569400|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569401|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569402|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569403|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569404|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569405|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569406|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569407|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569408|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569409|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569410|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569411|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569412|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569413|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569414|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569415|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569416|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569417|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569418|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569419|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
572661|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
569420|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569421|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569422|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569423|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569424|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569425|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569426|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569427|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569428|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569429|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569430|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569431|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569432|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569433|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569434|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569435|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569436|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569437|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569438|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569439|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569440|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569441|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569442|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
572662|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
569443|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569444|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569445|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569446|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569447|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569448|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569449|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569450|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569451|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569452|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569453|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569454|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569455|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569456|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569457|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569458|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569459|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569460|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569461|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569462|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569463|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569464|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569465|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
572663|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
569466|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569467|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569468|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569469|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569470|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569471|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569472|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569473|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569474|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569475|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569476|NCT00915278|E6|Reported Event|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569477|NCT00915278|E5|Reported Event|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569478|NCT00915278|E4|Reported Event|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569479|NCT00915278|E3|Reported Event|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569480|NCT00915278|E2|Reported Event|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569481|NCT00915278|E1|Reported Event|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
569482|NCT00915343|B1|Baseline|Entire Study|Included all participants randomized to receive hydrocortisone MR tablets orally OD first or hydrocortisone tablets orally TID first; in any of the intervention periods during the 12-week cross-over period of Part A or hydrocortisone MR tablets orally OD during the 6-month open-label period of Part B.
569483|NCT00915343|P3|Participant Flow|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD for 6 months.
569484|NCT00915343|P2|Participant Flow|Hydrocortisone TID Then Hydrocortisone MR OD - Part A|Participants received hydrocortisone tablets TID in the first intervention period then novel OD hydrocortisone MR tablets in the second intervention period, at the same total daily dose of 20 to 40 mg for 12 weeks.
569485|NCT00915343|P1|Participant Flow|Hydrocortisone MR OD Then Hydrocortisone TID - Part A|Participants received novel once daily (OD) hydrocortisone modified release (MR) tablets in the first intervention period then hydrocortisone tablets thrice daily (TID) in the second intervention period, at the same total daily dose of 20 to 40 milligram (mg) for 12 weeks.
569486|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569487|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569488|NCT00915343|O1|Outcome|Hydrocortisone OD Versus TID|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study. Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569489|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
569490|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569491|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569492|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
569493|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|During the 4-week run-in period prior to the first intervention period during Part A, participants on a twice-a-day (BID) regimen were transferred to a thrice-a-day (TID) regimen while maintaining the same total daily hydrocortisone dose. In the first and second intervention periods during Part A, participants were randomised to novel once daily (OD) treatment with hydrocortisone modified release (MR) tablets 20 to 40 milligram (mg) orally and the treatment continued for 12 weeks and returned every 4 weeks for study drug dispensation.
569494|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
569495|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569496|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569497|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
569498|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569499|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569500|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
569501|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569502|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569503|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
569504|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569505|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569506|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569507|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569508|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569509|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569510|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569511|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569512|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569513|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569514|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569515|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569516|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569517|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569518|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569519|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569520|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569521|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569522|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569523|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569524|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569525|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569526|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569527|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569528|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569529|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569530|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569531|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569532|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569533|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569534|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569535|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
572664|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
569537|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569538|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569539|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569540|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569541|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569542|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569543|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569544|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569545|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569546|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569547|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569548|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569549|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569550|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569551|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569552|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569553|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569554|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569555|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569556|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
569557|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
569558|NCT00915343|E5|Reported Event|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the entire 6-month period of Part B.
569559|NCT00915343|E4|Reported Event|Hydrocortisone MR Tablet OD - Part B (Second 3 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the second 3 months of Part B (6 months).
569560|NCT00915343|E3|Reported Event|Hydrocortisone MR Tablet OD - Part B (First 3 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the first 3 months of Part B (6 months).
569561|NCT00915343|E2|Reported Event|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally, thrice daily (TID) during the 12-week period of Part A.
569562|NCT00915343|E1|Reported Event|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone modified release (MR) tablets 20 to 40 mg orally, once daily (OD) during the 12-week period of Part A.
569563|NCT00915356|B6|Baseline|Total|Total of all reporting groups
569564|NCT00915356|B5|Baseline|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569565|NCT00915356|B4|Baseline|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569566|NCT00915356|B3|Baseline|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569567|NCT00915356|B2|Baseline|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569568|NCT00915356|B1|Baseline|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569569|NCT00915356|P5|Participant Flow|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569570|NCT00915356|P4|Participant Flow|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569571|NCT00915356|P3|Participant Flow|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569572|NCT00915356|P2|Participant Flow|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569573|NCT00915356|P1|Participant Flow|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569574|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569575|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569576|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569577|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569578|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569579|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569580|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569581|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569582|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569583|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569584|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569585|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569586|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569587|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569588|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569589|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569590|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569591|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569592|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569593|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569594|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569595|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569596|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569597|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569598|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569599|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569600|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569601|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569602|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569603|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569604|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569635|NCT00905515|B3|Baseline|Standard TAC|Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
569605|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569606|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569607|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569608|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569609|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569610|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569611|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569612|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569613|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569614|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569615|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569616|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569617|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569618|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569619|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569620|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569621|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569622|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569623|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569624|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569625|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569626|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569627|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569628|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569629|NCT00915356|E5|Reported Event|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
569630|NCT00915356|E4|Reported Event|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
569631|NCT00915356|E3|Reported Event|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
569632|NCT00915356|E2|Reported Event|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
569633|NCT00915356|E1|Reported Event|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
569634|NCT00905515|B4|Baseline|Total|Total of all reporting groups
569636|NCT00905515|B2|Baseline|Reduced TAC|Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
569637|NCT00905515|B1|Baseline|Remaining on CsA|Patients remained on CSA and were not converted to TAC.
569638|NCT00905515|P3|Participant Flow|Standard TAC|"Stable transplant recipients randomly assigned to convert to standard TAC with target trough levels of 6.0-8.9 ng/mL."
569639|NCT00905515|P2|Participant Flow|Reduced TAC|"Stable transplant recipients randomly assigned to convert to reduced Tacrolimus (TAC) with target trough levels 3.0-5.9 ng/mL."
569640|NCT00905515|P1|Participant Flow|Remaining on CsA|Stable transplant recipients randomly assigned to continue on Cyclosporine (CsA( with a target trough level of 50-250 ng/mL.
569641|NCT00905515|O3|Outcome|Standard TAC|"Stable transplant recipients randomly assigned to convert to standard TAC with target trough levels of 6.0-8.9 ng/mL."
569642|NCT00905515|O2|Outcome|Reduced TAC|"Stable transplant recipients randomly assigned to convert to reduced TAC with target trough levels 3.0-5.9 ng/mL."
569643|NCT00905515|O1|Outcome|Remaining on CsA|Stable transplant recipients randomly assigned to continue on CSA with a target trough level of 50-250 ng/mL.
569644|NCT00905515|E3|Reported Event|Standard TAC|Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
569645|NCT00905515|E2|Reported Event|Reduced TAC|Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
569646|NCT00905515|E1|Reported Event|Remaining on CsA|Patients remained on CSA and were not converted to TAC.
569647|NCT00905554|B3|Baseline|Total|Total of all reporting groups
569648|NCT00905554|B2|Baseline|Air Insufflation|air insufflation during the insertion phase of colonoscopy
569649|NCT00905554|B1|Baseline|Warm Water|warm water irrigation during the insertion phase of colonoscopy
569650|NCT00905554|P2|Participant Flow|Air Insufflation|air insufflation during the insertion phase of colonoscopy
569651|NCT00905554|P1|Participant Flow|Warm Water|warm water irrigation during the insertion phase of colonoscopy
569652|NCT00905554|O2|Outcome|Air Insufflation|air insufflation during the insertion phase of colonoscopy
569653|NCT00905554|O1|Outcome|Warm Water|warm water irrigation during the insertion phase of colonoscopy
569654|NCT00905554|O2|Outcome|Air Insufflation|air insufflation during the insertion phase of colonoscopy
569655|NCT00905554|O1|Outcome|Warm Water|warm water irrigation during the insertion phase of colonoscopy
569656|NCT00905554|E2|Reported Event|Air Insufflation|air insufflation during the insertion phase of colonoscopy
569657|NCT00905554|E1|Reported Event|Warm Water|warm water irrigation during the insertion phase of colonoscopy
569658|NCT00905567|B3|Baseline|Total|Total of all reporting groups
569659|NCT00905567|B2|Baseline|Topamax® (Reference) First|Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
569660|NCT00905567|B1|Baseline|Topiramate (Test) First|Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period
569661|NCT00905567|P2|Participant Flow|Topamax® (Reference) First|Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
569662|NCT00905567|P1|Participant Flow|Topiramate (Test) First|Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period
569663|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
569664|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
569665|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
569666|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
569667|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
569668|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
569669|NCT00905580|B3|Baseline|Total|Total of all reporting groups
569670|NCT00905580|B2|Baseline|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
569671|NCT00905580|B1|Baseline|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
569672|NCT00905580|P2|Participant Flow|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
569673|NCT00905580|P1|Participant Flow|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
569674|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
569675|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
569676|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
569677|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
569678|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
569679|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
569680|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
569681|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
569682|NCT00905580|E2|Reported Event|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
569683|NCT00905580|E1|Reported Event|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
569684|NCT00905606|B3|Baseline|Total|Total of all reporting groups
569685|NCT00905606|B2|Baseline|Topamax® (Reference) First|Topamax® Tablets, 2 x 25 mg reference product, dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product, dosed in second period
569686|NCT00905606|B1|Baseline|Topiramate (Test) First|Topiramate Tablets, 2 x 25 mg test product, dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product, dosed in second period
569687|NCT00905606|P2|Participant Flow|Topamax® (Reference) First|Topamax® Tablets, 2 x 25 mg reference product dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product dosed in second period
569688|NCT00905606|P1|Participant Flow|Topiramate (Test) First|Topiramate Tablets, 2 x 25 mg test product dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product dosed in second period.
569690|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
569691|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
569692|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
569693|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
569694|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
569695|NCT00905632|B8|Baseline|Total|Total of all reporting groups
569696|NCT00905632|B7|Baseline|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569697|NCT00905632|B6|Baseline|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569698|NCT00905632|B5|Baseline|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569699|NCT00905632|B4|Baseline|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569700|NCT00905632|B3|Baseline|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569701|NCT00905632|B2|Baseline|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569702|NCT00905632|B1|Baseline|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569703|NCT00905632|P7|Participant Flow|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
569704|NCT00905632|P6|Participant Flow|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
569705|NCT00905632|P5|Participant Flow|Treatment Experienced (TE): BI 207127 400 mg|Treatment Experienced (TE) patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
569706|NCT00905632|P4|Participant Flow|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
569707|NCT00905632|P3|Participant Flow|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
569708|NCT00905632|P2|Participant Flow|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
569709|NCT00905632|P1|Participant Flow|Treatment Naive (TN): Placebo|Treatment Naive (TN) patients to receive Placebo (given as a tablet, orally three times daily (tid)) + Peg-IFN (Peginterferon alfa (Peg-IFN) injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
569710|NCT00905632|O4|Outcome|BI 207127 800 mg|Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569711|NCT00905632|O3|Outcome|BI 207127 600 mg|Patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569712|NCT00905632|O2|Outcome|BI 207127 400 mg|Patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569713|NCT00905632|O1|Outcome|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569714|NCT00905632|O4|Outcome|BI 207127 800 mg|Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569715|NCT00905632|O3|Outcome|BI 207127 600 mg|Patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569716|NCT00905632|O2|Outcome|BI 207127 400 mg|Patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569717|NCT00905632|O1|Outcome|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569718|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569719|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569720|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569721|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569722|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569723|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569724|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569725|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569726|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569727|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569728|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569729|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569730|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569731|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
570035|NCT00906698|O2|Outcome|in Absence of Afatinib|60mg/m^2 vinorelbine per os in absence of afatinib
569732|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569733|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569734|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569735|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569736|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569737|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569738|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569739|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569740|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569741|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569742|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569743|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569744|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569745|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569746|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569747|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569748|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569749|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569750|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569751|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569752|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569753|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569754|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569755|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569756|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569757|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569758|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569759|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569760|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569761|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569762|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569763|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569764|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569765|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569766|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569767|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569768|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569769|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569770|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569771|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569772|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569773|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569774|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569775|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569776|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569777|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569778|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569779|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569780|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569781|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569782|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569783|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569784|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569785|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569786|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569787|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569788|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569789|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569790|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569791|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569792|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569793|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569794|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569795|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569796|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569797|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569798|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569799|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569800|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569801|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569802|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569803|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569804|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569805|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569806|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569807|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569808|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569809|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569810|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569811|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569812|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569813|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569814|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569815|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569816|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569817|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569818|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569819|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569820|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569821|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569822|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569823|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569824|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569825|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569826|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569827|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569828|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569829|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569830|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569831|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569832|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569833|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569834|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569835|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569836|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569837|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569838|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569839|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569840|NCT00905632|E4|Reported Event|BI 207127 800 mg|patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569841|NCT00905632|E3|Reported Event|BI 207127 600 mg|patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569842|NCT00905632|E2|Reported Event|BI 207127 400 mg|patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
569843|NCT00905632|E1|Reported Event|Placebo|patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
569844|NCT00905827|B4|Baseline|Total|Total of all reporting groups
569845|NCT00905827|B3|Baseline|Control|Control: no training
569846|NCT00905827|B2|Baseline|Intervention: E-training CAMS|Intervention: e-training CAMS training for providers
569847|NCT00905827|B1|Baseline|Intervention 1: In-person CAMS|Intervention: in-person CAMS training for providers
569848|NCT00905827|P3|Participant Flow|Control|Control: no training
569849|NCT00905827|P2|Participant Flow|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
569850|NCT00905827|P1|Participant Flow|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
569851|NCT00905827|O2|Outcome|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
569852|NCT00905827|O1|Outcome|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
569853|NCT00905827|O3|Outcome|Control|Control: no training
569854|NCT00905827|O2|Outcome|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
569855|NCT00905827|O1|Outcome|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
569856|NCT00905827|E3|Reported Event|Arm 3|Control Group: no training
569857|NCT00905827|E2|Reported Event|Arm 2|"Intervention: e-learning CAMS training for providers
CAMS: Collaborative assessment management in suicidality"
569858|NCT00905827|E1|Reported Event|Arm 1|"Intervention: in person CAMS training for providers
CAMS: Collaborative assessment management in suicidality"
569859|NCT00905840|B1|Baseline|Two Bone Level Implants in Interforaminal Region|"All patients received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon alloy. All implants were 3.3 mm in Ø, had a similar macro- and micro-structure, and had the chemically modified SLActive (Sand blasted Large grid Acid-etched) surface.
The implants were placed in the interforaminal region of the mandible, one implant in each side.
Implant placement was double-blinded as the implants are visually identical, and the study was unblinded after 12 month for the first analysis."
569860|NCT00905840|P1|Participant Flow|Titan Grade IV Implant and Titan Zircon Implant|Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Titan Zircon in the interforaminal region.
569861|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
569885|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
570012|NCT00906425|E2|Reported Event|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
569862|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
569863|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth design
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
569864|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth design
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
569865|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
569866|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
569867|NCT00905840|E1|Reported Event|Two Bone Level Implants in Interforaminal Region|Patients with edentulous mandibles received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
569868|NCT00906074|B3|Baseline|Total|Total of all reporting groups
569869|NCT00906074|B2|Baseline|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
569870|NCT00906074|B1|Baseline|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569871|NCT00906074|P2|Participant Flow|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
569872|NCT00906074|P1|Participant Flow|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569873|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569874|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569875|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569876|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569877|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
569878|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569879|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
569880|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569881|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569882|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569883|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
569884|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569886|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569887|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
569888|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569889|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
569890|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569891|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
569892|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569893|NCT00906074|E2|Reported Event|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
569894|NCT00906074|E1|Reported Event|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
569895|NCT00906087|B1|Baseline|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.
Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
569896|NCT00906087|P1|Participant Flow|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.
Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
569897|NCT00906087|O1|Outcome|Cosopt|"Intraocular pressure and blood pressure measurements will be compared under the following conditions: 1) after washout of clinical treatment, 2) after treatment with Cosopt, and 3) after another washout of Cosopt.
Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
569898|NCT00906087|O1|Outcome|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.
Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
569899|NCT00906087|O1|Outcome|Cosopt|"Intraocular pressure comparison after washout of Cosopt and while on treatment with Cosopt
Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
569900|NCT00906087|E2|Reported Event|Washout (no Glaucoma Medication)|After appropriate washout, no glaucoma medication was administered for 6 weeks.
569901|NCT00906087|E1|Reported Event|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.
Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
569902|NCT00906178|B3|Baseline|Total|Total of all reporting groups
569903|NCT00906178|B2|Baseline|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program"
569904|NCT00906178|B1|Baseline|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program"
569905|NCT00906178|P2|Participant Flow|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program"
569906|NCT00906178|P1|Participant Flow|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program"
569907|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program"
569908|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program"
569909|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program"
569910|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program"
569911|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program"
569912|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program"
569913|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program"
569914|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program"
569915|NCT00906178|E2|Reported Event|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program"
569916|NCT00906178|E1|Reported Event|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program"
569917|NCT00906204|B3|Baseline|Total|Total of all reporting groups
569918|NCT00906204|B2|Baseline|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4
Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
570011|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
569919|NCT00906204|B1|Baseline|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion
Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
569920|NCT00906204|P2|Participant Flow|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4
Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
569921|NCT00906204|P1|Participant Flow|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion
Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
569922|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4
Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
569923|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion
Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
569924|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4
Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
569925|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion
Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
569926|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4
Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
569927|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion
Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
569928|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4
Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
569929|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion
Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
569930|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4
Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
569931|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion
Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
569932|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4
Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
569933|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion
Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
569934|NCT00906204|E2|Reported Event|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4
Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
569935|NCT00906204|E1|Reported Event|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion
Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
569936|NCT00906243|B1|Baseline|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
569937|NCT00906243|P1|Participant Flow|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
569938|NCT00906243|O1|Outcome|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
569939|NCT00906243|E1|Reported Event|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
569940|NCT00906282|B1|Baseline|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks (4 cycles) of preoperative treatment given on Day 1 of each 21-day cycle:
Pemetrexed: 500 mg/m2 intravenously (IV) over 10 minutes
Carboplatin: AUC 6.0, IV infused over 30-60 minutes
At weeks 15-18, surgical candidates will have resection."
569941|NCT00906282|P1|Participant Flow|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:
Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;
Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle
Weeks 15-18: Patients deemed surgical candidates will have resection."
569942|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks (4 cycles) of preoperative treatment on Day 1 of each 21-day cycle:
Pemetrexed: 500 mg/m2 intravenously (IV) over 10 minutes
Carboplatin: AUC 6.0, IV infused over 30-60 minutes
At weeks 15-18, surgical candidates will have resection."
569943|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:
Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;
Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle
Weeks 15-18: Patients deemed surgical candidates will have resection."
569944|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:
Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;
Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle
Weeks 15-18: Patients deemed surgical candidates will have resection."
569945|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:
Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;
Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle
Weeks 15-18: Patients deemed surgical candidates will have resection."
569946|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:
Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;
Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle
Weeks 15-18: Patients deemed surgical candidates will have resection."
569947|NCT00906282|E1|Reported Event|Pemetrexed/Carboplatin|All patients who received at least 1 dose of study treatment were included in the safety analysis.
569948|NCT00906347|B3|Baseline|Total|Total of all reporting groups
569949|NCT00906347|B2|Baseline|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
569950|NCT00906347|B1|Baseline|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
569951|NCT00906347|P2|Participant Flow|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
569952|NCT00906347|P1|Participant Flow|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
569953|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
569954|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
569955|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
569956|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
569957|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
569958|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
569959|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
569960|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
569961|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
569962|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
569963|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
569964|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
569965|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
569966|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
569967|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
569968|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
569969|NCT00906347|E2|Reported Event|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
569970|NCT00906347|E1|Reported Event|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
569971|NCT00906399|B4|Baseline|Total|Total of all reporting groups
569972|NCT00906399|B3|Baseline|Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks
569973|NCT00906399|B2|Baseline|Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
569974|NCT00906399|B1|Baseline|Placebo|Placebo every 2 weeks for 48 weeks
569975|NCT00906399|P7|Participant Flow|Year 2: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
569976|NCT00906399|P6|Participant Flow|Year 2: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
569977|NCT00906399|P5|Participant Flow|Year 2: Placebo Followed by Peginterferon Beta-1a Q2W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
569978|NCT00906399|P4|Participant Flow|Year 2: Placebo Followed by Peginterferon Beta-1a Q4W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
569979|NCT00906399|P3|Participant Flow|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
569980|NCT00906399|P2|Participant Flow|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
569981|NCT00906399|P1|Participant Flow|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
569982|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
569983|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
569984|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
569985|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
569986|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
569987|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
569988|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
569989|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
569990|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
569991|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
569992|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
569993|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
569994|NCT00906399|E7|Reported Event|Year 2: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
569995|NCT00906399|E6|Reported Event|Year 2: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
569996|NCT00906399|E5|Reported Event|Year 2: Placebo Followed by Peginterferon Beta-1a Q2W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
569997|NCT00906399|E4|Reported Event|Year 2: Placebo Followed by Peginterferon Beta-1a Q4W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
569998|NCT00906399|E3|Reported Event|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
569999|NCT00906399|E2|Reported Event|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
570000|NCT00906399|E1|Reported Event|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
570001|NCT00906425|B3|Baseline|Total|Total of all reporting groups
570002|NCT00906425|B2|Baseline|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
570003|NCT00906425|B1|Baseline|Submerged Healing|The dental implants will be placed using a submerged healing treatment
570004|NCT00906425|P2|Participant Flow|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
570005|NCT00906425|P1|Participant Flow|Submerged Healing|The dental implants will be placed using a submerged healing treatment
570006|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
570007|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
570008|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
570009|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
570010|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
570013|NCT00906425|E1|Reported Event|Submerged Healing|The dental implants will be placed using a submerged healing treatment
570014|NCT00906503|B1|Baseline|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan
PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
570015|NCT00906503|P1|Participant Flow|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan
PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
570016|NCT00906503|O1|Outcome|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan
PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
570017|NCT00906503|E1|Reported Event|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan
PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
570018|NCT00906698|B7|Baseline|Total|Total of all reporting groups
570019|NCT00906698|B6|Baseline|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570020|NCT00906698|B5|Baseline|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570021|NCT00906698|B4|Baseline|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570022|NCT00906698|B3|Baseline|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570023|NCT00906698|B2|Baseline|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570024|NCT00906698|B1|Baseline|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570025|NCT00906698|P6|Participant Flow|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570026|NCT00906698|P5|Participant Flow|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570027|NCT00906698|P4|Participant Flow|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
570028|NCT00906698|P3|Participant Flow|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570029|NCT00906698|P2|Participant Flow|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570030|NCT00906698|P1|Participant Flow|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity
570031|NCT00906698|O2|Outcome|in Absence of Afatinib|60mg/m^2 vinorelbine per os in absence of afatinib
570032|NCT00906698|O1|Outcome|in Presence of Afatinib|60mg/m^2 vinorelbine per os in presence of afatinib
570033|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os
570034|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os
570036|NCT00906698|O1|Outcome|in Presence of Afatinib|60mg/m^2 vinorelbine per os in presence of afatinib
570037|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine per os
570038|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine per os
570039|NCT00906698|O2|Outcome|in Absence of Afatinib|60 mg/m^2 vinorelbine per os in absence of Afatinib
570040|NCT00906698|O1|Outcome|in Presence of Afatinib|60 mg/m^2 vinorelbine per os in presence of Afatinib
570041|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os.
570042|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os.
570043|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 or 50 mg
570044|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50 mg
570045|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
570046|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
570047|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 and 50mg Afatinib
570048|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50mg Afatinib
570049|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
570050|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
570051|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 or 50 mg
570052|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50 mg
570053|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
570054|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
570055|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570056|NCT00906698|O1|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570057|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570058|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570059|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570060|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570061|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570062|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570063|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570064|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570065|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570066|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570067|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570068|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570069|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570070|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570071|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570072|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570073|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570074|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570075|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570076|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570077|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570078|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570079|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570080|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570081|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570082|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570083|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570084|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570085|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570086|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570087|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570088|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570089|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570113|NCT00906776|B1|Baseline|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
570090|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570091|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570092|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570093|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570094|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570095|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570096|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570097|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570098|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570099|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570100|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570101|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570102|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570103|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570104|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
570105|NCT00906698|E6|Reported Event|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
570106|NCT00906698|E5|Reported Event|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
570107|NCT00906698|E4|Reported Event|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
570108|NCT00906698|E3|Reported Event|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
570109|NCT00906698|E2|Reported Event|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
570110|NCT00906698|E1|Reported Event|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
570111|NCT00906776|B3|Baseline|Total|Total of all reporting groups
570112|NCT00906776|B2|Baseline|Autogenous Bone|Autogenous bone from the patient
570114|NCT00906776|P2|Participant Flow|Autogenous Bone|Autogenous bone from the patient
570115|NCT00906776|P1|Participant Flow|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
570116|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
570117|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
570118|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
570119|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
570120|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
570121|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
570122|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
570123|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
570124|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
570125|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
570126|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
570127|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
570128|NCT00906776|E2|Reported Event|Autogenous Bone|Autogenous bone from the patient
570129|NCT00906776|E1|Reported Event|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
570130|NCT00906789|B1|Baseline|Radiologists|"Radiologists who have certification by the American Board of Radiology
Riverain OnGuard CAD Software : This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, both SoftView (TM) OnGuard (TM) CADe Software with be tested"
570131|NCT00906789|P1|Participant Flow|Radiologists|"Radiologists who have certification by the American Board of Radiology
Riverain OnGuard and SoftView Software : This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, Two types of software are tested: SoftView (TM). SoftView decreases the visibility of the ribs and clavicles on chest radiographs. OnGuard marks locations on chest radiographs meeting some of the software signs of lung nodules, a method often called Computer Aided Detection (CADe)."
570132|NCT00906789|O2|Outcome|Radiologists Using Softview Software|This software suppresses the visibility of the ribs and clavicles potentially revealing non-calcified nodules make less conspicuous by the bones projected on top of the nodules
570133|NCT00906789|O1|Outcome|Radiologists Control for SoftView|Control image interpretation unaided by software of either type. This is the control for the SoftView experiment. It uses the same radiologists (to avoid a bias that might result from using different radiologists) as the OnGuard Computer-aided detection software, but different cases.
570134|NCT00906789|O1|Outcome|Radiologists Using OnGuard Software: Difference of 1.0 and 5.1|Radiologists using OnGuard software. Two different versions were tested. OnGuard 1.0 and OnGuard 5.1. This software uses a computer algorithm to identify non-calcified lung nodules consistent with lung cancer. The value presented is the average difference in the areas under the LROC curve as demonstrated for the participating radiologists. The value for OnGuard 5.1 was subtracted from that of OnGuard 1.0, so a negative value indicates that OnGuard 5.1 had a higher value than OnGuard 1.0. The 95% confidence interval indicates that the OnGuard 5.1 was significantly improved.
570135|NCT00906789|O2|Outcome|Radiologists Using Softview Software|This software suppresses the visibility of the ribs and clavicles potentially revealing non-calcified nodules make less conspicuous by the bones projected on top of the nodules
570136|NCT00906789|O1|Outcome|Radiologists Control for SoftView|Control image interpretation unaided by software of either type. This is the control for the SoftView experiment. It uses the same radiologists (to avoid a bias that might result from using different radiologists) as the OnGuard Computer-aided detection software, but different cases.
570137|NCT00906789|E1|Reported Event|Participants|The 15 radiologists who participated
570138|NCT00906945|B6|Baseline|Total|Total of all reporting groups
570139|NCT00906945|B5|Baseline|Dose Level 5 (Includes MTD-Phase II)|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 750 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570140|NCT00906945|B4|Baseline|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 560 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570141|NCT00906945|B3|Baseline|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 420 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570142|NCT00906945|B2|Baseline|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 320 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570143|NCT00906945|B1|Baseline|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 240 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570144|NCT00906945|P6|Participant Flow|MTD - Phase II|"G-CSF MTD determined in Phase 1 SQ on Days 1-8
Plerixafor MTD determined in Phase 1 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570145|NCT00906945|P5|Participant Flow|Dose Level 5|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 750 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570146|NCT00906945|P4|Participant Flow|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 560 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570210|NCT00907257|P2|Participant Flow|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
570147|NCT00906945|P3|Participant Flow|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 420 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570148|NCT00906945|P2|Participant Flow|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 320 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570149|NCT00906945|P1|Participant Flow|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 240 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570150|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570151|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570152|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570153|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570154|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570155|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570156|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570157|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570158|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570159|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570160|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570161|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
570162|NCT00906945|O5|Outcome|Grade 5|
570163|NCT00906945|O4|Outcome|Grade 4|
570164|NCT00906945|O3|Outcome|Grade 3|
570165|NCT00906945|O2|Outcome|Grade 2|
570166|NCT00906945|O1|Outcome|Grade 1|
570167|NCT00906945|O1|Outcome|Phase II (MTD)|
570168|NCT00906945|O1|Outcome|Phase I (Includes Levels 1-5)|
570169|NCT00906945|E6|Reported Event|MTD - Phase II|"G-CSF MTD determined in Phase 1 SQ on Days 1-8
Plerixafor MTD determined in Phase 1 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570170|NCT00906945|E5|Reported Event|Dose Level 5|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 750 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570171|NCT00906945|E4|Reported Event|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 560 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570172|NCT00906945|E3|Reported Event|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 420 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570173|NCT00906945|E2|Reported Event|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 320 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570174|NCT00906945|E1|Reported Event|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8
Plerixafor 240 mcg/kg/d IV qd
Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
570175|NCT00906971|B3|Baseline|Total|Total of all reporting groups
570176|NCT00906971|B2|Baseline|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
570177|NCT00906971|B1|Baseline|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
570178|NCT00906971|P2|Participant Flow|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
570179|NCT00906971|P1|Participant Flow|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
570180|NCT00906971|O2|Outcome|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
570181|NCT00906971|O1|Outcome|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
570182|NCT00906971|O2|Outcome|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
570183|NCT00906971|O1|Outcome|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
570184|NCT00906971|E2|Reported Event|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
570185|NCT00906971|E1|Reported Event|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
570186|NCT00907088|B3|Baseline|Total|Total of all reporting groups
570187|NCT00907088|B2|Baseline|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling provided in the control group, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
570188|NCT00907088|B1|Baseline|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel based on the Canadian Paediatric Society Guidelines. Nutrition counselling occurs at the 9-month visit and is repeated at the 15-month visit if the child has not transitioned into the use of a cup. Recommendations include iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
570189|NCT00907088|P2|Participant Flow|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
570190|NCT00907088|P1|Participant Flow|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
570191|NCT00907088|O2|Outcome|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
570192|NCT00907088|O1|Outcome|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
570193|NCT00907088|E2|Reported Event|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
570194|NCT00907088|E1|Reported Event|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
570195|NCT00907101|B1|Baseline|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
570196|NCT00907101|P1|Participant Flow|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
570197|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
570198|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
570199|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
570200|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
570201|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
570202|NCT00907101|E1|Reported Event|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
570203|NCT00907218|B1|Baseline|No Data Was Analyzed|
570204|NCT00907218|P1|Participant Flow|Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper|Varenicline (Chantix) : Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if
570205|NCT00907218|O1|Outcome|Adults Who Meet DSM-IV-TR Criteria for ADHD and Smoke Cigarett|
570206|NCT00907218|E1|Reported Event|Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper|Varenicline (Chantix) : Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if
570207|NCT00907257|B3|Baseline|Total|Total of all reporting groups
570208|NCT00907257|B2|Baseline|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
570209|NCT00907257|B1|Baseline|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
570211|NCT00907257|P1|Participant Flow|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
570212|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
570213|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
570214|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
570215|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
570216|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
570217|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
570218|NCT00907257|E2|Reported Event|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
570219|NCT00907257|E1|Reported Event|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
570220|NCT00907335|B3|Baseline|Total|Total of all reporting groups
570221|NCT00907335|B2|Baseline|Vehicle Control|Color matched facial gel vehicle control used once daily
570222|NCT00907335|B1|Baseline|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
570223|NCT00907335|P2|Participant Flow|Vehicle Control|Color matched facial gel vehicle control used once daily
570224|NCT00907335|P1|Participant Flow|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
570225|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
570226|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
570227|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
570228|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
570229|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
570230|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
570231|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
570232|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
570233|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
570234|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
570235|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
570236|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
570237|NCT00907335|E2|Reported Event|Vehicle Control|Color matched facial gel vehicle control used once daily
570238|NCT00907335|E1|Reported Event|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
570239|NCT00907374|B3|Baseline|Total|Total of all reporting groups
570240|NCT00907374|B2|Baseline|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
570241|NCT00907374|B1|Baseline|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
570242|NCT00907374|P2|Participant Flow|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
570243|NCT00907374|P1|Participant Flow|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
570244|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
570245|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
570246|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
570247|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
570248|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
570249|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
570250|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
570251|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
570252|NCT00907374|E2|Reported Event|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
570253|NCT00907374|E1|Reported Event|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
570254|NCT00907426|B4|Baseline|Total|Total of all reporting groups
570255|NCT00907426|B3|Baseline|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
570256|NCT00907426|B2|Baseline|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
570257|NCT00907426|B1|Baseline|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
570290|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
570291|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
570258|NCT00907426|P3|Participant Flow|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
570259|NCT00907426|P2|Participant Flow|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
570260|NCT00907426|P1|Participant Flow|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
570261|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
570262|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
570263|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
570264|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
570265|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
570266|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
570267|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
570268|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
570269|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
570270|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
570271|NCT00907426|E3|Reported Event|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
570272|NCT00907426|E2|Reported Event|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
570273|NCT00907426|E1|Reported Event|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
570274|NCT00907478|B4|Baseline|Total|Total of all reporting groups
570275|NCT00907478|B3|Baseline|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
570276|NCT00907478|B2|Baseline|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
570277|NCT00907478|B1|Baseline|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
570278|NCT00907478|P3|Participant Flow|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
570279|NCT00907478|P2|Participant Flow|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
570280|NCT00907478|P1|Participant Flow|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
570281|NCT00907478|O1|Outcome|Romiplostim|Participants received once weekly romiplostim for 3 years.
570282|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
570283|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
570284|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
570285|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
570286|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
570287|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
570288|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
570289|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
572665|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
570292|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
570293|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
570294|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
570295|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
570296|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
570297|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
570298|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
570299|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
570300|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
570301|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
570302|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
570303|NCT00907478|E4|Reported Event|Overall|Participants received once weekly romiplostim for 3 years.
570304|NCT00907478|E3|Reported Event|Cohort 3|Year 1 Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
570305|NCT00907478|E2|Reported Event|Cohort 2|Year 1 Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
570306|NCT00907478|E1|Reported Event|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
570307|NCT00915473|B3|Baseline|Total|Total of all reporting groups
570308|NCT00915473|B2|Baseline|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570309|NCT00915473|B1|Baseline|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570310|NCT00915473|P2|Participant Flow|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570311|NCT00915473|P1|Participant Flow|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570312|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570313|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570314|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570315|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570316|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570317|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570318|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570319|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
570320|NCT00915473|E2|Reported Event|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the greater occipital nerve.
570321|NCT00915473|E1|Reported Event|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the greater occipital nerve.
570322|NCT00915499|B3|Baseline|Total|Total of all reporting groups
570323|NCT00915499|B2|Baseline|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
570324|NCT00915499|B1|Baseline|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
570325|NCT00915499|P2|Participant Flow|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
570326|NCT00915499|P1|Participant Flow|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
570327|NCT00915499|O2|Outcome|CPAP Mode|Positive airway pressure in the continuous positive airway pressure (CPAP) mode
570328|NCT00915499|O1|Outcome|ASV Mode|Positive airway pressure in the adaptive servo-ventilation (ASV) mode
570329|NCT00915499|O2|Outcome|CPAP Mode|Positive airway pressure in the continuous positive airway pressure (CPAP) mode
570330|NCT00915499|O1|Outcome|ASV Mode|Positive airway pressure in the adaptive servo-ventilation (ASV) mode
570331|NCT00915499|E2|Reported Event|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
570332|NCT00915499|E1|Reported Event|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
570333|NCT00915525|B3|Baseline|Total|Total of all reporting groups
570334|NCT00915525|B2|Baseline|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570335|NCT00915525|B1|Baseline|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570336|NCT00915525|P2|Participant Flow|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570337|NCT00915525|P1|Participant Flow|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570338|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570339|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570340|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570341|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570342|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570343|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570344|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570345|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570346|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570347|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570348|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570349|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570350|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570351|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570352|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570353|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570354|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570355|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570356|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570357|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570358|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570359|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570360|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570361|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570362|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570363|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570364|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570365|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570366|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
572666|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
570367|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570368|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570369|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570370|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570371|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570372|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570373|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570374|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570375|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570376|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570377|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570378|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570379|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570380|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570381|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570382|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570383|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570384|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570385|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570386|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570387|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570388|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570389|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570390|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570391|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570392|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570393|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570394|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570395|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570396|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570397|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570398|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570399|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570400|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570518|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570401|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570402|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570403|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570404|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570405|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570406|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570407|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570408|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570409|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570410|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570411|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570412|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570413|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570414|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570415|NCT00915525|E22|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 13|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570416|NCT00915525|E21|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 12|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570417|NCT00915525|E20|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 11|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570418|NCT00915525|E19|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 10|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570419|NCT00915525|E18|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 10|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570420|NCT00915525|E17|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 9|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570421|NCT00915525|E16|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 9|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570422|NCT00915525|E15|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 8|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570423|NCT00915525|E14|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 8|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570424|NCT00915525|E13|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 7|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570425|NCT00915525|E12|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 7|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570426|NCT00915525|E11|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 6|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570427|NCT00915525|E10|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 6|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570428|NCT00915525|E9|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 5|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570429|NCT00915525|E8|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 5|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570430|NCT00915525|E7|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 4|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570431|NCT00915525|E6|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 4|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570432|NCT00915525|E5|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 3|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570519|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570433|NCT00915525|E4|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 3|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570434|NCT00915525|E3|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 2|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570435|NCT00915525|E2|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 2|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570436|NCT00915525|E1|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 1|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
570437|NCT00915551|B3|Baseline|Total|Total of all reporting groups
570438|NCT00915551|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
570439|NCT00915551|B1|Baseline|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
570440|NCT00915551|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
570441|NCT00915551|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
570442|NCT00915551|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
570443|NCT00915551|O1|Outcome|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days
570444|NCT00915551|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
570445|NCT00915551|O1|Outcome|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days
570446|NCT00915551|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
570447|NCT00915551|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
570448|NCT00915590|B3|Baseline|Total|Total of all reporting groups
570449|NCT00915590|B2|Baseline|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570450|NCT00915590|B1|Baseline|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570451|NCT00915590|P2|Participant Flow|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570452|NCT00915590|P1|Participant Flow|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570453|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570454|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570455|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570456|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570457|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570458|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570459|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570460|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570461|NCT00915590|O2|Outcome|IL-1RA First, Then Placebo|"It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
Placebo: Custom eye drop eye three times a day in both eyes for a period of 6 weeks
IL-1Ra: 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks"
570520|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570521|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570462|NCT00915590|O1|Outcome|Placebo First, Then IL-1RA|"It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.
Placebo: Custom eye drop eye three times a day in both eyes for a period of 6 weeks
IL-1Ra: 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks"
570463|NCT00915590|O2|Outcome|IL-1RA First, Then Placebo|"It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570464|NCT00915590|O1|Outcome|Placebo First, Then IL-1RA|"It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.
IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
570465|NCT00915590|E3|Reported Event|Off Treatment|Off treatment
570466|NCT00915590|E2|Reported Event|IL-1Ra|IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
570467|NCT00915590|E1|Reported Event|Placebo|Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks
570468|NCT00915603|B3|Baseline|Total|Total of all reporting groups
570469|NCT00915603|B2|Baseline|Paclitaxel/Carboplatin/Everolimus|
570470|NCT00915603|B1|Baseline|Paclitaxel/Carboplatin/Placebo|
570471|NCT00915603|P2|Participant Flow|Paclitaxel/Carboplatin/Everolimus|
570472|NCT00915603|P1|Participant Flow|Paclitaxel/Carboplatin/Placebo|
570473|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
570474|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
570475|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
570476|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
570477|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
570478|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
570479|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
570480|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
570481|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
570482|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
570483|NCT00915603|E2|Reported Event|Paclitaxel/Bevacizumab/Placebo|
570484|NCT00915603|E1|Reported Event|Paclitaxel/Bevacizumab/Everolimus|
570485|NCT00915655|B1|Baseline|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
570486|NCT00915655|P1|Participant Flow|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
570487|NCT00915655|O1|Outcome|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
570488|NCT00915655|O1|Outcome|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
570489|NCT00915655|E1|Reported Event|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
570490|NCT00915759|B1|Baseline|ProKera and Bandage Contact Lens|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
570491|NCT00915759|P1|Participant Flow|ProKera/Bandage Contact Lens|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
570492|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 3: bandage contact lens in place until postoperative day 1
570493|NCT00915759|O1|Outcome|ProKera|Group 3: ProKera in place until postoperative day 1
570494|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 2: bandage contact lens in place until postoperative day 3
570495|NCT00915759|O1|Outcome|ProKera|Group 2: ProKera in place until postoperative day 3
570496|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 1: bandage contact lens in place until complete corneal re-repithelialization (healing)
570497|NCT00915759|O1|Outcome|ProKera|Group 1: ProKera in place until complete corneal re-repithelialization (healing)
570498|NCT00915759|E2|Reported Event|Bandage Contact Lens|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
570499|NCT00915759|E1|Reported Event|ProKera|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
570500|NCT00915772|B4|Baseline|Total|Total of all reporting groups
570501|NCT00915772|B3|Baseline|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570502|NCT00915772|B2|Baseline|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570503|NCT00915772|B1|Baseline|M1000|Metformin 1000mg monotherapy twice daily
570504|NCT00915772|P3|Participant Flow|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570505|NCT00915772|P2|Participant Flow|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570506|NCT00915772|P1|Participant Flow|M1000|Metformin 1000mg monotherapy twice daily
570507|NCT00915772|O4|Outcome|Post-treat|7 days follow-up period
570508|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570509|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570510|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570511|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570512|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570513|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570514|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570515|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570516|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570517|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570522|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570523|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570524|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570525|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570526|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570527|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570528|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570529|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570530|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570531|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570532|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570533|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570534|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570535|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570536|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570537|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570538|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570539|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570540|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570541|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570542|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570543|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570544|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
570545|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
570546|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
570547|NCT00915772|E3|Reported Event|L2.5+M1000|Linagliptin 2.5 mg + Metformin 1000 mg twice daily
570548|NCT00915772|E2|Reported Event|L2.5+M500|Linagliptin 2.5 mg + Metformin 500 mg twice daily
570549|NCT00915772|E1|Reported Event|M1000|Metformin 1000 mg twice daily
570550|NCT00915798|B5|Baseline|Total|Total of all reporting groups
570551|NCT00915798|B4|Baseline|Control Nonsmokers|Control nonsmokers participated in the abstinence condition.
570552|NCT00915798|B3|Baseline|Control Smokers|Control smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
570553|NCT00915798|B2|Baseline|ADHD Nonsmokers|ADHD nonsmokers participated in the abstinence condition.
570554|NCT00915798|B1|Baseline|ADHD Smokers|ADHD smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
570555|NCT00915798|P4|Participant Flow|Control Nonsmokers|Control nonsmokers participated in one fMRI scan during an experimental task consisting of mathematical problems.
570556|NCT00915798|P3|Participant Flow|Control Smokers|"Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).
Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
570557|NCT00915798|P2|Participant Flow|Nonsmokers With ADHD|Nonsmokers with ADHD participated in one fMRI scan during an experimental task consisting of mathematical problems.
570558|NCT00915798|P1|Participant Flow|Smokers With ADHD|"Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).
Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
570559|NCT00915798|O4|Outcome|Control Nonsmokers|
570560|NCT00915798|O3|Outcome|Control Smokers|
570561|NCT00915798|O2|Outcome|ADHD Nonsmokers|
570562|NCT00915798|O1|Outcome|ADHD Smokers|
570563|NCT00915798|O4|Outcome|Control Nonsmokers|Control nonsmokers provided a blood sample.
570564|NCT00915798|O3|Outcome|Control Smokers|Control smokers provided a blood sample.
570565|NCT00915798|O2|Outcome|Nonsmokers With ADHD|Nonsmokers with ADHD provided a blood sample.
570566|NCT00915798|O1|Outcome|Smokers With ADHD|Smokers with ADHD provided a blood sample.
570567|NCT00915798|O6|Outcome|Control Smokers After Smoking|Control smokers after smoking the first cigarette of the day
570568|NCT00915798|O5|Outcome|Smokers With ADHD After Smoking|Smokers with ADHD after smoking the first cigarette of the day
570569|NCT00915798|O4|Outcome|Control Nonsmokers|Nonsmokers participate in one condition.
570570|NCT00915798|O3|Outcome|Control Smokers After Abstinence|Control smokers after overnight abstinence (withdrawal).
570571|NCT00915798|O2|Outcome|Nonsmokers With ADHD|Nonsmokers participate in one condition.
570572|NCT00915798|O1|Outcome|Smokers With ADHD After Abstinence|Smokers with ADHD after overnight abstinence (withdrawal).
570573|NCT00915798|E4|Reported Event|Control Nonsmokers|Control nonsmokers participated in one fMRI scan during an experimental task consisting of mathematical problems.
570574|NCT00915798|E3|Reported Event|Control Smokers|"Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).
Cigarette smoking versus withdrawal in smokers: Each participant will undergo an fMRI scan during an experimental task consisting of mathematical problems and unpleasant and neutral pictures. Smokers will undergo two fMRI scans during similar experimental tasks under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
570575|NCT00915798|E2|Reported Event|Nonsmokers With ADHD|Nonsmokers with ADHD participated in one fMRI scan during an experimental task consisting of mathematical problems.
570576|NCT00915798|E1|Reported Event|Smokers With ADHD|"Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).
Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
570577|NCT00918346|B1|Baseline|Entire Study Population|Includes all 43 randomized patients (86 eyes)
570578|NCT00918346|P2|Participant Flow|Unpreserved Formulation First, Then Preserved Formulation|Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks, then preserved formulation (after washout)
570579|NCT00918346|P1|Participant Flow|Preserved Formulation First, Then Unpreserved Formulation|Tafluprost 0.0015% preserved formulation once daily for first 4 weeks, then unpreserved formulation (after washout)
570580|NCT00918346|O1|Outcome|RM ANCOVA: PP Efficacy Dataset|randomized patients who completed the study per protocol (PP)
570581|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized who received at least one dose of study medication and had at least one IOP measurement
570582|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
570583|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
570584|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
570585|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
570586|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized and received study medication
570587|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized and received study medication
570588|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
570589|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
570590|NCT00918346|E2|Reported Event|Unpreserved Formulation|Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks
570591|NCT00918346|E1|Reported Event|Preserved Formulation|Tafluprost 0.0015% preserved formulation once daily for 4 weeks
570592|NCT00918385|B3|Baseline|Total|Total of all reporting groups
570593|NCT00918385|B2|Baseline|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
570594|NCT00918385|B1|Baseline|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
570595|NCT00918385|P2|Participant Flow|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
570596|NCT00918385|P1|Participant Flow|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
570597|NCT00918385|O1|Outcome|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
570598|NCT00918385|O1|Outcome|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
570599|NCT00918385|O2|Outcome|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
570600|NCT00918385|O1|Outcome|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
570601|NCT00918385|E3|Reported Event|Combination Nilutamide and Dasatinib|
570602|NCT00918385|E2|Reported Event|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
570603|NCT00918385|E1|Reported Event|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
570604|NCT00918580|B1|Baseline|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570605|NCT00918580|P1|Participant Flow|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570606|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570607|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570608|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570609|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570610|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570611|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570612|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570613|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570614|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570615|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570616|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570617|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
570618|NCT00918580|E4|Reported Event|1-Year Follow-up|Participants previously immunized with 23vPS who received 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from the 6-month follow-up telephone contact after 13vPnC Dose 2 to the 1-year follow-up after 13vPnC Dose 2.
570619|NCT00918580|E3|Reported Event|6-Month Follow-up|Participants previously immunized with 23vPS who received at least 1 of the 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from last 13vPnC Dose (Dose 1 or Dose 2) blood draw to the 6-month follow-up telephone contact.
570620|NCT00918580|E2|Reported Event|13vPnC Dose 2|Participants previously immunized with 23vPS who received Dose 2 of 0.5 mL 13vPnC intramuscular injection, assessed between 13vPnC Dose 2 and before 13vPnC Dose 2 blood draw.
570621|NCT00918580|E1|Reported Event|13vPnC Dose 1|Participants previously immunized with 23vPS who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose2.
570622|NCT00918671|B1|Baseline|Medication-overuse Headache|Chronic daily headache combined with medication overuse
570623|NCT00918671|P1|Participant Flow|Medication-overuse Headache|Chronic daily headache combined with medication overuse
570624|NCT00918671|O1|Outcome|Medication-overuse Headache|Chronic daily headache combined with medication overuse
570625|NCT00918671|O1|Outcome|Medication-overuse Headache|Chronic daily headache combined with medication overuse
570626|NCT00918671|E1|Reported Event|Medication-overuse Headache|Chronic daily headache combined with medication overuse
570627|NCT00918684|B1|Baseline|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily"
570628|NCT00918684|P1|Participant Flow|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily"
570629|NCT00918684|O1|Outcome|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily"
570630|NCT00918684|O1|Outcome|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily"
570631|NCT00918684|O1|Outcome|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily"
570632|NCT00918684|E1|Reported Event|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily"
570633|NCT00918736|B1|Baseline|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
570634|NCT00918736|P1|Participant Flow|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
570635|NCT00918736|O1|Outcome|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
570636|NCT00918736|E1|Reported Event|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
570637|NCT00918749|B4|Baseline|Total|Total of all reporting groups
570638|NCT00918749|B3|Baseline|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570639|NCT00918749|B2|Baseline|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570640|NCT00918749|B1|Baseline|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570641|NCT00918749|P3|Participant Flow|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570642|NCT00918749|P2|Participant Flow|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570643|NCT00918749|P1|Participant Flow|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570644|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570645|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570646|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570647|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570648|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570649|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570650|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570651|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570652|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570653|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570654|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570655|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570656|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570657|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570658|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570659|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570660|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570661|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570662|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570663|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570664|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570665|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570666|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570667|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570668|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570669|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570670|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570671|NCT00918749|E3|Reported Event|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570672|NCT00918749|E2|Reported Event|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
570673|NCT00918749|E1|Reported Event|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
570674|NCT00918866|B3|Baseline|Total|Total of all reporting groups
570675|NCT00918866|B2|Baseline|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
570676|NCT00918866|B1|Baseline|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
570677|NCT00918866|P2|Participant Flow|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
570678|NCT00918866|P1|Participant Flow|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
570679|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
570680|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
570681|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
570682|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
570683|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
570684|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
570685|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
570686|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
570687|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
570688|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
570689|NCT00918866|E2|Reported Event|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
570690|NCT00918866|E1|Reported Event|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
570691|NCT00918879|B3|Baseline|Total|Total of all reporting groups
570692|NCT00918879|B2|Baseline|Placebo|Placebo tablet, once daily( OD) for 24 weeks
570693|NCT00918879|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
572667|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
570694|NCT00918879|P2|Participant Flow|Placebo|Placebo tablet, once daily( OD) for 24 weeks
570695|NCT00918879|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
570696|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
570697|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
570698|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
570699|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
570700|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
570701|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
570702|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
570703|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
570704|NCT00918879|E2|Reported Event|Placebo|Placebo tablet, once daily( OD) for 24 weeks
570705|NCT00918879|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
570706|NCT00918931|B1|Baseline|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
570707|NCT00918931|P1|Participant Flow|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
570708|NCT00918931|O1|Outcome|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
570709|NCT00918931|E1|Reported Event|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
570710|NCT00918957|B3|Baseline|Total|Total of all reporting groups
570711|NCT00918957|B2|Baseline|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570712|NCT00918957|B1|Baseline|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570713|NCT00918957|P2|Participant Flow|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570714|NCT00918957|P1|Participant Flow|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570715|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570716|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570717|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570718|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570719|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570720|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570721|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570722|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570723|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570724|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570725|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570726|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570727|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570728|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570729|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570730|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570731|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570732|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570733|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570734|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570735|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570736|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570737|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570738|NCT00918957|E2|Reported Event|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
570739|NCT00918957|E1|Reported Event|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
570740|NCT00919035|B1|Baseline|Torisel|"Single Agent Temsorilmus (Torisel®)
Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
570741|NCT00919035|P1|Participant Flow|Torisel|"Single Agent Temsirolimus (Torisel®)
torisel: Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
570742|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)
Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
570743|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)
Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
570744|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)
Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
570745|NCT00919035|E1|Reported Event|Torisel|"Single Agent Temsirolimus (Torisel®)
Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
570746|NCT00919061|B1|Baseline|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
570747|NCT00919061|P1|Participant Flow|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
570748|NCT00919061|O1|Outcome|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
570749|NCT00919061|O1|Outcome|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
570812|NCT00919191|P1|Participant Flow|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
570750|NCT00919061|E1|Reported Event|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
570751|NCT00919113|B3|Baseline|Total|Total of all reporting groups
570752|NCT00919113|B2|Baseline|Placebo|identical buffer
570753|NCT00919113|B1|Baseline|Uracyst|2% sodium chondroitin sulfate
570754|NCT00919113|P2|Participant Flow|Placebo|identical buffer
570755|NCT00919113|P1|Participant Flow|Uracyst|2% sodium chondroitin sulfate
570756|NCT00919113|O2|Outcome|Placebo|identical buffer
570757|NCT00919113|O1|Outcome|Uracyst|2% sodium chondroitin sulfate
570758|NCT00919113|O2|Outcome|Placebo|identical buffer
570759|NCT00919113|O1|Outcome|Uracyst|2% sodium chondroitin sulfate
570760|NCT00919113|E2|Reported Event|Placebo|"identical buffer
One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis."
570761|NCT00919113|E1|Reported Event|Uracyst|"2% sodium chondroitin sulfate
One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis."
570762|NCT00919126|B4|Baseline|Total|Total of all reporting groups
570763|NCT00919126|B3|Baseline|Group C|Medical Air in Oxygen (45%-55%)
570764|NCT00919126|B2|Baseline|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570765|NCT00919126|B1|Baseline|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570766|NCT00919126|P3|Participant Flow|Group C|Medical Air in Oxygen (45%-55%)
570767|NCT00919126|P2|Participant Flow|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570768|NCT00919126|P1|Participant Flow|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570769|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570770|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570771|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570772|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570773|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570774|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570775|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570776|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570777|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570778|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570779|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570780|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570781|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570782|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570783|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570784|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570785|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570786|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570787|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570788|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570789|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570790|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570791|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570792|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570793|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570794|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570795|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570796|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570797|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570798|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570799|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570800|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570801|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570802|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570803|NCT00919126|O2|Outcome|Group B|Xenon 70%(65%-75%) in Oxygen (25%-35%)
570804|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570805|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
570806|NCT00919126|O2|Outcome|Group B|Xenon 70%(65%-75%) in Oxygen (25%-35%)
570807|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570808|NCT00919126|E3|Reported Event|Group C|Medical Air in Oxygen (45%-55%)
570809|NCT00919126|E2|Reported Event|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
570810|NCT00919126|E1|Reported Event|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
570811|NCT00919191|B1|Baseline|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
570813|NCT00919191|O2|Outcome|Adapalene Benzoyl Peroxide Facial Gel|Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
570814|NCT00919191|O1|Outcome|Tretinoin Facial Gel|Tretinoin Facial Gel used once daily on one side of the face in a split-face model
572668|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
570815|NCT00919191|O2|Outcome|Adapalene Benzoyl Peroxide Facial Gel|Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
570816|NCT00919191|O1|Outcome|Tretinoin Facial Gel|Tretinoin Facial Gel used once daily on one side of the face in a split face model
570817|NCT00919191|E1|Reported Event|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
570818|NCT00919633|B5|Baseline|Total|Total of all reporting groups
570819|NCT00919633|B4|Baseline|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570820|NCT00919633|B3|Baseline|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570821|NCT00919633|B2|Baseline|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570822|NCT00919633|B1|Baseline|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks
peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570823|NCT00919633|P4|Participant Flow|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570824|NCT00919633|P3|Participant Flow|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570825|NCT00919633|P2|Participant Flow|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570826|NCT00919633|P1|Participant Flow|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks
peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570827|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570828|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570829|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570830|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks
peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570831|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570832|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570833|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570834|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks
peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570835|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570836|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570837|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570838|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks
peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570839|NCT00919633|E4|Reported Event|INTRON A 160,000|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570840|NCT00919633|E3|Reported Event|INTRON A 120,000|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570841|NCT00919633|E2|Reported Event|INTRON A 80,000|"continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570842|NCT00919633|E1|Reported Event|PEGINTRON 1.5|"subcutaneous weekly for 48 weeks
peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin"
570843|NCT00919711|B3|Baseline|Total|Total of all reporting groups
570844|NCT00919711|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
570845|NCT00919711|B1|Baseline|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
570846|NCT00919711|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
570847|NCT00919711|P1|Participant Flow|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
570848|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
570849|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
570850|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
570851|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
570852|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
570853|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
570854|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
570855|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
570856|NCT00919711|E2|Reported Event|Denosumab 60 mg Q6M|
570857|NCT00919711|E1|Reported Event|Risedronate 150 mg QM|
570858|NCT00919724|B3|Baseline|Total|Total of all reporting groups
570859|NCT00919724|B2|Baseline|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
570860|NCT00919724|B1|Baseline|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
570861|NCT00919724|P2|Participant Flow|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
570862|NCT00919724|P1|Participant Flow|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
570863|NCT00919724|O2|Outcome|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
570864|NCT00919724|O1|Outcome|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
570865|NCT00919724|E2|Reported Event|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
570866|NCT00919724|E1|Reported Event|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
570867|NCT00919763|B3|Baseline|Total|Total of all reporting groups
570868|NCT00919763|B2|Baseline|CD 2027 Vehicle, Twice Daily|Topical Ointment
570869|NCT00919763|B1|Baseline|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
570870|NCT00919763|P2|Participant Flow|CD 2027 Vehicle, Twice Daily|Topical Ointment
570871|NCT00919763|P1|Participant Flow|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
570872|NCT00919763|O2|Outcome|CD 2027 Vehicle, Twice Daily|Topical Ointment
570873|NCT00919763|O1|Outcome|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
570874|NCT00919763|E2|Reported Event|CD 2027 Vehicle, Twice Daily|Topical Ointment
570875|NCT00919763|E1|Reported Event|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
570876|NCT00919802|B1|Baseline|All Study Participants|Patients will be randomized to receive a single dose of oxytocin 40 IU (20 IU to each nostril) or saline. Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time the patient will receive the alternative intranasal agent. Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described.
570877|NCT00919802|P2|Participant Flow|Intranasal Saline Followed With Intranasal Oxytocin|"Saline, 4ml intranasally, once
Patients will be randomized to receive saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects.
Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time they will receive the alternative intranasal agent, Oxytocin a single dose of oxytocin 40 IU (20 IU to each nostril). Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described."
570878|NCT00919802|P1|Participant Flow|Intranasal Oxytocin, Followed by Intranasal Saline|"Oxytocin, 40 IU intranasally, once
Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time the patient will receive the alternative intranasal agent. Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described."
571283|NCT00910728|P6|Participant Flow|70 mg QD|AZD1480 may be administered orally in capsules
570879|NCT00919802|O2|Outcome|Saline as a Nasal Spray|"Saline, 4ml intranasally, once
Saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed."
570880|NCT00919802|O1|Outcome|Oxytocin|"Oxytocin, 40 IU intranasally, once
Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed."
570881|NCT00919802|O2|Outcome|Saline as a Nasal Spray|"Saline, 4ml intranasally, once
Saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed."
570882|NCT00919802|O1|Outcome|Oxytocin|"Oxytocin, 40 IU intranasally, once
Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed."
570883|NCT00919802|E2|Reported Event|Saline as a Nasal Spray|"Saline, 4ml intranasally, once
Saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed."
570884|NCT00919802|E1|Reported Event|Oxytocin|"Oxytocin, 40 IU intranasally, once
Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed."
570885|NCT00919854|B1|Baseline|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
570886|NCT00919854|P1|Participant Flow|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
570887|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
570888|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
570889|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
570890|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
570891|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
570892|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
570893|NCT00919854|E1|Reported Event|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
570894|NCT00919867|B7|Baseline|Total|Total of all reporting groups
570895|NCT00919867|B6|Baseline|SPD503 + Vyvanse, Then Vyvanse, Then SPD503|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
570896|NCT00919867|B5|Baseline|SPD503 + Vyvanse First, Then SPD503, Then Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
571284|NCT00910728|P5|Participant Flow|50 mg QD|AZD1480 may be administered orally in capsules
570897|NCT00919867|B4|Baseline|Vyvanse First, Then SPD503 + Vyvanse, Then SPD503|Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
570898|NCT00919867|B3|Baseline|Vyvanse First, Then SPD503, Then SPD503 + Vyvanse|Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
570899|NCT00919867|B2|Baseline|SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
570900|NCT00919867|B1|Baseline|SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse|SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
570901|NCT00919867|P6|Participant Flow|SPD503 + Vyvanse, Then Vyvanse, Then SPD503|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
570902|NCT00919867|P5|Participant Flow|SPD503 + Vyvanse First, Then SPD503, Then Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
570903|NCT00919867|P4|Participant Flow|Vyvanse First, Then SPD503 + Vyvanse, Then SPD503|Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
570904|NCT00919867|P3|Participant Flow|Vyvanse First, Then SPD503, Then SPD503 + Vyvanse|Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
570905|NCT00919867|P2|Participant Flow|SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
570906|NCT00919867|P1|Participant Flow|SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse|SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
570907|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
570908|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
570909|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
570910|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
570911|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
570912|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
570913|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
570914|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
570915|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
570916|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
570917|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
570918|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
570919|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
570920|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
570921|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
570922|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
570923|NCT00919867|E3|Reported Event|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
570924|NCT00919867|E2|Reported Event|Vyvanse Alone|Single 50 mg dose
570925|NCT00919867|E1|Reported Event|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
570926|NCT00919893|B3|Baseline|Total|Total of all reporting groups
570927|NCT00919893|B2|Baseline|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
570928|NCT00919893|B1|Baseline|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
570929|NCT00919893|P2|Participant Flow|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
570930|NCT00919893|P1|Participant Flow|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
570931|NCT00919893|O2|Outcome|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
570932|NCT00919893|O1|Outcome|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
570933|NCT00919893|O2|Outcome|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
570934|NCT00919893|O1|Outcome|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
570935|NCT00919932|B3|Baseline|Total|Total of all reporting groups
570985|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
570936|NCT00919932|B2|Baseline|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.
Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
570937|NCT00919932|B1|Baseline|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.
Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
570938|NCT00919932|P2|Participant Flow|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.
Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
570939|NCT00919932|P1|Participant Flow|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.
Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
570940|NCT00919932|O2|Outcome|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.
Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
570941|NCT00919932|O1|Outcome|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.
Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
570942|NCT00919932|O2|Outcome|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.
Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
570943|NCT00919932|O1|Outcome|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.
Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
570944|NCT00919932|E2|Reported Event|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.
Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
570945|NCT00919932|E1|Reported Event|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.
Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
570946|NCT00920023|B1|Baseline|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
570947|NCT00920023|P1|Participant Flow|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
570948|NCT00920023|O1|Outcome|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
570949|NCT00920023|O1|Outcome|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
570950|NCT00920023|E1|Reported Event|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
570951|NCT00920075|B1|Baseline|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
571075|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
570952|NCT00920075|P1|Participant Flow|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
570953|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
570954|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
570955|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
570956|NCT00920075|E1|Reported Event|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
570957|NCT00920140|B6|Baseline|Total|Total of all reporting groups
570958|NCT00920140|B5|Baseline|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
570959|NCT00920140|B4|Baseline|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
570960|NCT00920140|B3|Baseline|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
570961|NCT00920140|B2|Baseline|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570962|NCT00920140|B1|Baseline|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
570963|NCT00920140|P5|Participant Flow|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
570964|NCT00920140|P4|Participant Flow|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or chronic myelomonocytic leukemia (CMML) with RAS wild type (wt) or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
570965|NCT00920140|P3|Participant Flow|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplasia (MDS) with rat sarcoma (RAS) mutation received GSK1120212 2 mg OD as a continuous dose.
570966|NCT00920140|P2|Participant Flow|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570967|NCT00920140|P1|Participant Flow|GSK1120212 < 2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
570968|NCT00920140|O3|Outcome|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
570969|NCT00920140|O2|Outcome|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
570970|NCT00920140|O1|Outcome|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
570971|NCT00920140|O1|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570972|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570973|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
570974|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
570975|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570976|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
570977|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
570978|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570979|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
570980|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
570981|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570982|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
570983|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
570984|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570986|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
570987|NCT00920140|O3|Outcome|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
570988|NCT00920140|O2|Outcome|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
570989|NCT00920140|O1|Outcome|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
570990|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570991|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
570992|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570993|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
570994|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570995|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
570996|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570997|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
570998|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
570999|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
571000|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
571001|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
571002|NCT00920140|E2|Reported Event|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
571003|NCT00920140|E1|Reported Event|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
571004|NCT00920231|B3|Baseline|Total|Total of all reporting groups
571005|NCT00920231|B2|Baseline|Modified System|"a second group of 8 blind subjects were tested with a modified computer vision system.
same task as the initial group with improved computer vision algorithm."
571006|NCT00920231|B1|Baseline|Initial System|"a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.
the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors."
571007|NCT00920231|P2|Participant Flow|Modified Computer Vision System|"a second group of 8 blind subjects were tested with a modified computer vision system.
same task as the initial group with improved computer vision algorithm."
571008|NCT00920231|P1|Participant Flow|Initial Computer Vision System|"a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.
the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors."
571009|NCT00920231|O2|Outcome|Modified System|this computer vision system incorporates the needed changes identified by the first group of subjects using the initial prototype system.
571010|NCT00920231|O1|Outcome|Initial Prototype|The initial prototype is a system that has been successfully tested in outdoor navigation and successfully tested for simple object recognition.
571011|NCT00920231|O2|Outcome|Modified System|a second group of 8 subjects were tested with a system that incorporated modifications identified by the first group using the initial prototype system.
571012|NCT00920231|O1|Outcome|Initial System|The subjects were asked to travel over a novel path in the hospital after given instructions how to reach the final destination. the computer vision system was used to provide additional information as when to turn and in what direction. the subjects were allowed to also use their white cane
571013|NCT00920231|E2|Reported Event|Arm 2|"The subject without the assist device can only locate the object by groping and random searching with hands.
No adverse events"
571014|NCT00920231|E1|Reported Event|Arm 1|"the blind subject is asked to locate a randomly placed object with the assistance of the webcam/laptop computer.
computer vision: a webcam-laptop based system to assist the blind in locating objects and in way finding.
No adverse events"
571015|NCT00920309|B3|Baseline|Total|Total of all reporting groups
571016|NCT00920309|B2|Baseline|Standard of Care-Placebo|
571017|NCT00920309|B1|Baseline|Rapamycin|"Drug: Rapamycin
Other Names:
sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
571018|NCT00920309|P2|Participant Flow|Standard of Care-Placebo|
571019|NCT00920309|P1|Participant Flow|Rapamycin|"Drug: Rapamycin
Other Names:
sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
571020|NCT00920309|O2|Outcome|Standard of Care-Placebo|
571021|NCT00920309|O1|Outcome|Rapamycin|"Drug: Rapamycin
Other Names:
sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
571022|NCT00920309|O2|Outcome|Standard of Care-Placebo|
571023|NCT00920309|O1|Outcome|Rapamycin|The study was terminated before any enrolled patients were treated for 2 years.
571024|NCT00920309|E2|Reported Event|Standard of Care-Placebo|
571025|NCT00920309|E1|Reported Event|Rapamycin|"Drug: Rapamycin
Other Names:
sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
571026|NCT00920374|B3|Baseline|Total|Total of all reporting groups
571027|NCT00920374|B2|Baseline|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571028|NCT00920374|B1|Baseline|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571029|NCT00920374|P2|Participant Flow|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571030|NCT00920374|P1|Participant Flow|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571031|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571032|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571033|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571034|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571035|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571036|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571037|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571038|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571039|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571040|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571041|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571042|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571043|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571044|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571045|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571046|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571047|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571048|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571049|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571050|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571051|NCT00920374|E2|Reported Event|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
571052|NCT00920374|E1|Reported Event|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
571053|NCT00920621|B5|Baseline|Total|Total of all reporting groups
571054|NCT00920621|B4|Baseline|Placebo (Children)|"Children of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
571055|NCT00920621|B3|Baseline|Vitamin D Treatment (Children)|Children of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
571056|NCT00920621|B2|Baseline|Placebo (Mothers)|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
571057|NCT00920621|B1|Baseline|Vitamin D Treatment (Mothers)|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)
571058|NCT00920621|P4|Participant Flow|Placebo (Offspring)|"Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control"
571059|NCT00920621|P3|Participant Flow|Vitamin D Treatment (Offspring)|Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)
571060|NCT00920621|P2|Participant Flow|Placebo (Mothers)|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
571061|NCT00920621|P1|Participant Flow|Vitamin D Treatment (Mothers)|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
571062|NCT00920621|O2|Outcome|Placebo|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
571063|NCT00920621|O1|Outcome|Vitamin D Treatment|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
571064|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
571065|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
571066|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
571067|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
571068|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
571069|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
571070|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
571071|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
571072|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
571073|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
571074|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
571076|NCT00920621|O2|Outcome|Placebo|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
571077|NCT00920621|O1|Outcome|Vitamin D Treatment|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
571078|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
571079|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
571080|NCT00920621|E4|Reported Event|Placebo (Offspring)|"Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
571081|NCT00920621|E3|Reported Event|Vitamin D Treatment (Offspring)|Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
571082|NCT00920621|E2|Reported Event|Placebo (Mothers)|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
571083|NCT00920621|E1|Reported Event|Vitamin D Treatment (Mothers)|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
571084|NCT00920647|B5|Baseline|Total|Total of all reporting groups
571085|NCT00920647|B4|Baseline|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571086|NCT00920647|B3|Baseline|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571087|NCT00920647|B2|Baseline|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
571088|NCT00920647|B1|Baseline|Control|Untreated Patients
571089|NCT00920647|P4|Participant Flow|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571090|NCT00920647|P3|Participant Flow|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571091|NCT00920647|P2|Participant Flow|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
571092|NCT00920647|P1|Participant Flow|Control|Untreated Patients
571093|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571094|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571095|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
571096|NCT00920647|O1|Outcome|Control|Untreated Patients, Observed Value
571097|NCT00920647|O3|Outcome|Idursulfase IT (30 mg)|"monthly using an intrathecal drug delivery device (IDDD)
Value represents concentration at 36 hours post drug administration"
571098|NCT00920647|O2|Outcome|Idursulfase IT (10 mg)|"monthly using an intrathecal drug delivery device (IDDD)
Value represents concentration at 24 hours post drug administration"
571099|NCT00920647|O1|Outcome|Idursulfase IT (1 mg)|"monthly using an intrathecal drug delivery device (IDDD)
Value represents concentration at 36 hours post drug administration."
571100|NCT00920647|O3|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571101|NCT00920647|O2|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571102|NCT00920647|O1|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD.
571103|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571104|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571105|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
571106|NCT00920647|O1|Outcome|Control|Untreated Patients
571107|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571108|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571109|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
571110|NCT00920647|O1|Outcome|Control|Untreated Patients
571111|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571112|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571113|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
571114|NCT00920647|O1|Outcome|Control|Untreated Patients
571115|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571116|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571117|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
571118|NCT00920647|O1|Outcome|Control|Untreated Patients
571119|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571120|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571121|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
571122|NCT00920647|O1|Outcome|Control|
571123|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571124|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571125|NCT00920647|O2|Outcome|Idursulfase IT (1mg)|monthly using an intrathecal drug delivery device (IDDD)
571126|NCT00920647|O1|Outcome|Control|Untreated Patients
571127|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571128|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571129|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
571130|NCT00920647|O1|Outcome|Control|Untreated Patients for 6 months, Observed Value
571131|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571132|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571133|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
571134|NCT00920647|O1|Outcome|Control|Untreated Patients
571135|NCT00920647|E4|Reported Event|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
571136|NCT00920647|E3|Reported Event|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
571137|NCT00920647|E2|Reported Event|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
571138|NCT00920647|E1|Reported Event|Control|Untreated Patients
571139|NCT00920686|B4|Baseline|Total|Total of all reporting groups
571140|NCT00920686|B3|Baseline|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
571141|NCT00920686|B2|Baseline|NXN-188 600 mg|3 x 200 mg capsules
571142|NCT00920686|B1|Baseline|Placebo|3 x 0 mg capsules
571143|NCT00920686|P3|Participant Flow|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
571144|NCT00920686|P2|Participant Flow|NXN-188 600 mg|3 x 200 mg capsules
571145|NCT00920686|P1|Participant Flow|Placebo|3 x 0 mg capsules
571146|NCT00920686|O3|Outcome|Sumatriptan Succinate|1 x 100 mg, 2 x 0 mg capsules
571147|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
571148|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
571149|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
571150|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
571151|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
571152|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
571153|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
571154|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
571155|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
571156|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
571157|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
571158|NCT00920686|O3|Outcome|Sumatriptan Succinate|100 mg of sumatriptan succinate provided as 1 capsule containing 100 mg of sumatriptan and 2 capsules containing placebo
571159|NCT00920686|O2|Outcome|NXN-188|600 mg of NXN-188 provided as 3 x 200 mg capsules.
571160|NCT00920686|O1|Outcome|Placebo|Three capsules containing placebo
571161|NCT00920686|E3|Reported Event|Sumatriptan Succinate|100 mg sumatriptan. Three capsules, one containing 100 mg sumatriptan succinate and two placebo-containing capsules were provided. All capsules were taken at the same time.
571162|NCT00920686|E2|Reported Event|NXN-188|600 mg NXN-188. Three capsules each containing 200 mg of NXN-188 were provided. All capsules were taken at the same time.
571163|NCT00920686|E1|Reported Event|Placebo|Three placebo capsules were provided. All capsules were taken at the same time.
571164|NCT00920790|B1|Baseline|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
571165|NCT00920790|P1|Participant Flow|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
571166|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
571167|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
571168|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
571169|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
571170|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
571171|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
571172|NCT00920790|E1|Reported Event|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
571173|NCT00910520|B3|Baseline|Total|Total of all reporting groups
571174|NCT00910520|B2|Baseline|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571175|NCT00910520|B1|Baseline|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571176|NCT00910520|P2|Participant Flow|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571177|NCT00910520|P1|Participant Flow|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571178|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571179|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571180|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571181|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571182|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571183|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571184|NCT00910520|E2|Reported Event|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571285|NCT00910728|P4|Participant Flow|30 mg QD|AZD1480 may be administered orally in capsules
571185|NCT00910520|E1|Reported Event|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571186|NCT00910624|B5|Baseline|Total|Total of all reporting groups
571187|NCT00910624|B4|Baseline|BOC + PEG/RBV: Other|Participants who were characterized as “Other” (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571188|NCT00910624|B3|Baseline|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571189|NCT00910624|B2|Baseline|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571190|NCT00910624|B1|Baseline|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571191|NCT00910624|P4|Participant Flow|BOC + PEG/RBV: Other|Participants who were characterized as “Other” (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571192|NCT00910624|P3|Participant Flow|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571193|NCT00910624|P2|Participant Flow|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571194|NCT00910624|P1|Participant Flow|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at Treatment Week (TW) 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571195|NCT00910624|O4|Outcome|BOC + PEG/RBV: All|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571196|NCT00910624|O3|Outcome|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571197|NCT00910624|O2|Outcome|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571229|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
571230|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
571231|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
572669|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
571198|NCT00910624|O1|Outcome|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571199|NCT00910624|O1|Outcome|All Treated Participants|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571200|NCT00910624|O4|Outcome|BOC + PEG/RBV: All|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571201|NCT00910624|O3|Outcome|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571202|NCT00910624|O2|Outcome|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571203|NCT00910624|O1|Outcome|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571204|NCT00910624|E1|Reported Event|All Treated Participants|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
571205|NCT00910663|B3|Baseline|Total|Total of all reporting groups
571206|NCT00910663|B2|Baseline|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
571207|NCT00910663|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
571208|NCT00910663|P2|Participant Flow|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
571209|NCT00910663|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
571210|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
571211|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
571212|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
571213|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
571214|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
571215|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
571216|NCT00910663|E2|Reported Event|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
571217|NCT00910663|E1|Reported Event|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
571218|NCT00910689|B5|Baseline|Total|Total of all reporting groups
571219|NCT00910689|B4|Baseline|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
571220|NCT00910689|B3|Baseline|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
571221|NCT00910689|B2|Baseline|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
571222|NCT00910689|B1|Baseline|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
571223|NCT00910689|P4|Participant Flow|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
571224|NCT00910689|P3|Participant Flow|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
571225|NCT00910689|P2|Participant Flow|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
571226|NCT00910689|P1|Participant Flow|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
571227|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
571228|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
571232|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
571233|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
571234|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
571235|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
571236|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
571237|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
571238|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
571239|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
571240|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
571241|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
571242|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
571243|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
571244|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
571245|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
571246|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
571247|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
571248|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
571249|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
571250|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
571251|NCT00910689|E4|Reported Event|OAT + BMM + Beta-Blocker at Month 5|"Optimal Acute Therapy (OAT)+ Behavioral Migraine Management (BMM)+ Beta-Blocker(Propranolol/Nadolol).
Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side effect) assessed after dose adjustment(Month 5)."
571252|NCT00910689|E3|Reported Event|OAT + BMM + PL at Month 5|"Optimal Acute Therapy + Behavioral Migraine Management(BMM) + Beta-Blocker(Propranolol/Nadolol) Placebo.
Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect)as assessed after dose adjustment(Month 5)."
571253|NCT00910689|E2|Reported Event|OAT + Beta-Blocker at Month 5|Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/Nadolol. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect assessed after dose adjustment(Month 5).
571254|NCT00910689|E1|Reported Event|OAT + Placebo (PL) at Month 5|Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/ Nadolol)Placebo. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or Other side effect at Month 5 following dose adjustment.
571255|NCT00910715|B4|Baseline|Total|Total of all reporting groups
571256|NCT00910715|B3|Baseline|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
571257|NCT00910715|B2|Baseline|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
571258|NCT00910715|B1|Baseline|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
571259|NCT00910715|P3|Participant Flow|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
571260|NCT00910715|P2|Participant Flow|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
571261|NCT00910715|P1|Participant Flow|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
571262|NCT00910715|O2|Outcome|Controls|control subjects without a history of Lyme borreliosis
571263|NCT00910715|O1|Outcome|EM Patients|EM patients treated with doxycycline 100 mg b.i.d. for 10 or 15 days
571264|NCT00910715|O3|Outcome|Controls|subjects without a history of Lyme borreliosis included in the study as controls only at the 6 month follow-up time point, results are given only in the secondary outcome section
571265|NCT00910715|O2|Outcome|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
571266|NCT00910715|O1|Outcome|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
571267|NCT00910715|E3|Reported Event|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
571268|NCT00910715|E2|Reported Event|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
571269|NCT00910715|E1|Reported Event|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
571270|NCT00910728|B10|Baseline|Total|Total of all reporting groups
571271|NCT00910728|B9|Baseline|20 mg QD|AZD1480 may be administered orally in capsules
571272|NCT00910728|B8|Baseline|10 mg BID|AZD1480 may be administered orally in capsules
571273|NCT00910728|B7|Baseline|50 mg QD|AZD1480 may be administered orally in capsules
571274|NCT00910728|B6|Baseline|30 mg QD|AZD1480 may be administered orally in capsules
571275|NCT00910728|B5|Baseline|15 mg BID|AZD1480 may be administered orally in capsules
571276|NCT00910728|B4|Baseline|70 mg QD|AZD1480 may be administered orally in capsules
571277|NCT00910728|B3|Baseline|10 mg QD|AZD1480 may be administered orally in capsules
571278|NCT00910728|B2|Baseline|5.0 mg QD|AZD1480 may be administered orally in capsules
571279|NCT00910728|B1|Baseline|2.5 mg QD|AZD1480 may be administered orally in capsules
571280|NCT00910728|P9|Participant Flow|20 mg QD|AZD1480 may be administered orally in capsules
571281|NCT00910728|P8|Participant Flow|15 mg BID|AZD1480 may be administered orally in capsules
571282|NCT00910728|P7|Participant Flow|10 mg BID|AZD1480 may be administered orally in capsules
571286|NCT00910728|P3|Participant Flow|10 mg QD|AZD1480 may be administered orally in capsules
571287|NCT00910728|P2|Participant Flow|5.0 mg QD|AZD1480 may be administered orally in capsules
571288|NCT00910728|P1|Participant Flow|2.5 mg QD|AZD1480 may be administered orally in capsules
571289|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571290|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571291|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571292|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571293|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571294|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571295|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571296|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571297|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571298|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571299|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571300|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571301|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571302|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571303|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571304|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571305|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571306|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571307|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571308|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571309|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571310|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571311|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571312|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571313|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571314|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571315|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571316|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571317|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571318|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571319|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571320|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571321|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571322|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571323|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571324|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571325|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571326|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571327|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571328|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571329|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571330|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571331|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571332|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571333|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571334|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571335|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571336|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571337|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571338|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571339|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571340|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571341|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571342|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571343|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571344|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571345|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571346|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571347|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571348|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571349|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571350|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571351|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571352|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571353|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571354|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571355|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571356|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571357|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571358|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571359|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571360|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571361|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571362|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571363|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571364|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571365|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571366|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571367|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571368|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571369|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571370|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571371|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571372|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571373|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571374|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571375|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571376|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571377|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571378|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571379|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571380|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571381|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571382|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571383|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571384|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571385|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571386|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571387|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571388|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
571389|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
571390|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
571391|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
571392|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
571393|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
571394|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
571395|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
571396|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
571397|NCT00910728|E9|Reported Event|10 mg BID|AZD1480 may be administered orally in capsules
571398|NCT00910728|E8|Reported Event|50 mg QD|AZD1480 may be administered orally in capsules
571399|NCT00910728|E7|Reported Event|30 mg QD|AZD1480 may be administered orally in capsules
571400|NCT00910728|E6|Reported Event|20 mg QD|AZD1480 may be administered orally in capsules
571401|NCT00910728|E5|Reported Event|15 mg BID|AZD1480 may be administered orally in capsules
571402|NCT00910728|E4|Reported Event|70 mg QD|AZD1480 may be administered orally in capsules
571403|NCT00910728|E3|Reported Event|10 mg QD|AZD1480 may be administered orally in capsules
571404|NCT00910728|E2|Reported Event|5.0 mg QD|AZD1480 may be administered orally in capsules
571405|NCT00910728|E1|Reported Event|2.5 mg QD|AZD1480 may be administered orally in capsules
571406|NCT00910845|B3|Baseline|Total|Total of all reporting groups
571407|NCT00910845|B2|Baseline|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571408|NCT00910845|B1|Baseline|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571409|NCT00910845|P2|Participant Flow|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571410|NCT00910845|P1|Participant Flow|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571411|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571412|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571413|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571444|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
572670|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
571414|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571415|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571416|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571417|NCT00910845|E2|Reported Event|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
571418|NCT00910845|E1|Reported Event|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
571419|NCT00910858|B4|Baseline|Total|Total of all reporting groups
571420|NCT00910858|B3|Baseline|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.
During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571421|NCT00910858|B2|Baseline|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571422|NCT00910858|B1|Baseline|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.
During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571423|NCT00910858|P3|Participant Flow|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.
During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571424|NCT00910858|P2|Participant Flow|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571425|NCT00910858|P1|Participant Flow|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.
During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571426|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571461|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571427|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571428|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
571429|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571430|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571431|NCT00910858|O3|Outcome|Overall|All participants in the Safety population.
571432|NCT00910858|O2|Outcome|Non-responders|Participants who were not erythroid responders.
571433|NCT00910858|O1|Outcome|Responders|Participants with a erythroid response.
571434|NCT00910858|O3|Outcome|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.
During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571435|NCT00910858|O2|Outcome|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571436|NCT00910858|O1|Outcome|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.
During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571437|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571438|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571439|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
571440|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
571441|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
571442|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
571443|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
571445|NCT00910858|E2|Reported Event|15 mg Lenalidomide|"Participants with low- or intermediate-1-risk MDS were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571446|NCT00910858|E1|Reported Event|10 mg Lenalidomide|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.
During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.
After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
571447|NCT00910871|B1|Baseline|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
571448|NCT00910871|P1|Participant Flow|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
571449|NCT00910871|O1|Outcome|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
571450|NCT00910871|O1|Outcome|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
571451|NCT00910871|E1|Reported Event|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
571452|NCT00910910|B3|Baseline|Total|Total of all reporting groups
571453|NCT00910910|B2|Baseline|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571454|NCT00910910|B1|Baseline|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571455|NCT00910910|P2|Participant Flow|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571456|NCT00910910|P1|Participant Flow|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571457|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571458|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571459|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571460|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571462|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571463|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571464|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571465|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571466|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571467|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571468|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571469|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571470|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571471|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571472|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571473|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571474|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571475|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571492|NCT00910988|B2|Baseline|Ziprasidone (Drug First)|Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
571493|NCT00910988|B1|Baseline|Olanzapine (Drug First)|Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
572671|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
571476|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571477|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571478|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571479|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571480|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571481|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571482|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571483|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571484|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571485|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571486|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571487|NCT00910910|E2|Reported Event|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
571488|NCT00910910|E1|Reported Event|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
571489|NCT00910988|B5|Baseline|Total|Total of all reporting groups
571490|NCT00910988|B4|Baseline|Ziprasidone (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
571491|NCT00910988|B3|Baseline|Olanzapine (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
571683|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
571494|NCT00910988|P4|Participant Flow|Ziprasidone (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
571495|NCT00910988|P3|Participant Flow|Olanzapine (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
571496|NCT00910988|P2|Participant Flow|Ziprasidone (Drug First)|Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
571497|NCT00910988|P1|Participant Flow|Olanzapine (Drug First)|Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
571498|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
571499|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
571500|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
571501|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
571502|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
571503|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
571504|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
571505|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
571506|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
571507|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
571508|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
571509|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
571510|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
571511|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
571512|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
571513|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
571514|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
571515|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
571516|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
571517|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
571518|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
571519|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
571520|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
571521|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
571522|NCT00910988|O8|Outcome|Ziprasidone (Drug/Placebo)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
571523|NCT00910988|O7|Outcome|Ziprasidone (Drug/Placebo)-Drug|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
571524|NCT00910988|O6|Outcome|Ziprasidone (Placebo/Drug)-Drug|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
571525|NCT00910988|O5|Outcome|Ziprasidone (Placebo/Drug)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
571526|NCT00910988|O4|Outcome|Olanzapine (Placebo/Drug)-Drug|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
571527|NCT00910988|O3|Outcome|Olanzapine (Placebo/Drug)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
571528|NCT00910988|O2|Outcome|Olanzapine (Drug/Placebo)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
571529|NCT00910988|O1|Outcome|Olanzapine (Drug/Placebo)-Drug|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
571530|NCT00910988|E8|Reported Event|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
571531|NCT00910988|E7|Reported Event|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
571532|NCT00910988|E6|Reported Event|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
571533|NCT00910988|E5|Reported Event|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
571534|NCT00910988|E4|Reported Event|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
571535|NCT00910988|E3|Reported Event|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
571536|NCT00910988|E2|Reported Event|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
571537|NCT00910988|E1|Reported Event|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
571538|NCT00911144|B3|Baseline|Total|Total of all reporting groups
571539|NCT00911144|B2|Baseline|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571540|NCT00911144|B1|Baseline|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571541|NCT00911144|P2|Participant Flow|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571542|NCT00911144|P1|Participant Flow|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571543|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571544|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571545|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571546|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571547|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571548|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571549|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571550|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571551|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571552|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571553|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571554|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571555|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571556|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571557|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571558|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571559|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571560|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571561|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571562|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571563|NCT00911144|E2|Reported Event|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571564|NCT00911144|E1|Reported Event|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
571565|NCT00911157|B3|Baseline|Total|Total of all reporting groups
571566|NCT00911157|B2|Baseline|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
571567|NCT00911157|B1|Baseline|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
571568|NCT00911157|P2|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
571569|NCT00911157|P1|Participant Flow|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
571570|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
571571|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
571572|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
571573|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
571574|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
571593|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
572672|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
571575|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
571576|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
571577|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
571578|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
571579|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
571580|NCT00911157|E2|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
571581|NCT00911157|E1|Reported Event|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
571582|NCT00911170|B3|Baseline|Total|Total of all reporting groups
571583|NCT00911170|B2|Baseline|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571584|NCT00911170|B1|Baseline|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571585|NCT00911170|P2|Participant Flow|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). During the long-term follow-up period, further chemotherapy and/or biologic agents (for example, bevacizumab) were to continue at the discretion of the treating physician.
571586|NCT00911170|P1|Participant Flow|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). During the long-term follow-up period, further chemotherapy and/or biologic agents (for example, bevacizumab) were to continue at the discretion of the treating physician.
571587|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571588|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571589|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571590|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571591|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571592|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571653|NCT00911443|B5|Baseline|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571594|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571595|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571596|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571597|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571598|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571599|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571600|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571601|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571602|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571603|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571604|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571605|NCT00911170|E2|Reported Event|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571606|NCT00911170|E1|Reported Event|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
571607|NCT00911274|B3|Baseline|Total|Total of all reporting groups
571608|NCT00911274|B2|Baseline|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
571609|NCT00911274|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.
571610|NCT00911274|P2|Participant Flow|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
571611|NCT00911274|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.
571612|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
571613|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
571614|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
571615|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
571616|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
571617|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
571618|NCT00911300|B3|Baseline|Total|Total of all reporting groups
571619|NCT00911300|B2|Baseline|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571654|NCT00911443|B4|Baseline|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571655|NCT00911443|B3|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571620|NCT00911300|B1|Baseline|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571621|NCT00911300|P2|Participant Flow|Unfractioned Heparin (UFH)/Vitamin K Antagonist (VKA)|Both CN and CP participants received an initial intravenous (i.v.) bolus injection of 70 international units (IU)/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/hour (h) (at least 1250 IU per hour). The infusion dose was adjusted to maintain an activated partial thromboplastin time (aPTT) at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target international normalized ratio (INR) of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571622|NCT00911300|P1|Participant Flow|Fondaparinux|For clot-negative (CN) participants (par.), 7.5 milligrams (mg) fondaparinux was injected once daily (OD) subcutaneously (for par. with body weight [BW] 50-100 kilograms [kg]); for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For clot-positive (CP) par. with creatinine clearance (CrCl) >= 50 milliliters (mL)/minute (min), 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571623|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571624|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571625|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571626|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571627|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571637|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571628|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571629|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571630|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571631|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571632|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571633|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571634|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571635|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571636|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571652|NCT00911443|B6|Baseline|Total|Total of all reporting groups
572673|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
571638|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571639|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571640|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571641|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571642|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571643|NCT00911300|E2|Reported Event|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
571644|NCT00911300|E1|Reported Event|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
571645|NCT00911326|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
571646|NCT00911326|P1|Participant Flow|Lymphoseek|Intraoral and cutaneous (head and neck) squamous cell carcinoma (T1-T4, N0, M0) patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m for sentinel lymph node biopsy and elective neck dissection of cervical lymph nodes.
571647|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
571648|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
571649|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
571650|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
571651|NCT00911326|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
571656|NCT00911443|B2|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571657|NCT00911443|B1|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571658|NCT00911443|P5|Participant Flow|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571659|NCT00911443|P4|Participant Flow|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571660|NCT00911443|P3|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571661|NCT00911443|P2|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571662|NCT00911443|P1|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571663|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571664|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571665|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571666|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571667|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571668|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571669|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571670|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571671|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571672|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571673|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571674|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571675|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571676|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571677|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
571678|NCT00911495|B1|Baseline|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
571679|NCT00911495|P1|Participant Flow|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
571680|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
571681|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
571682|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
572674|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
571684|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
571685|NCT00911495|E1|Reported Event|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
571686|NCT00911534|B3|Baseline|Total|Total of all reporting groups
571687|NCT00911534|B2|Baseline|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
571688|NCT00911534|B1|Baseline|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
571689|NCT00911534|P2|Participant Flow|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
571690|NCT00911534|P1|Participant Flow|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
571691|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
571692|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
571693|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
571694|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
571695|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
571696|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
571697|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
571698|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
571699|NCT00911534|E2|Reported Event|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
571700|NCT00911534|E1|Reported Event|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
571701|NCT00911547|B5|Baseline|Total|Total of all reporting groups
571702|NCT00911547|B4|Baseline|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571703|NCT00911547|B3|Baseline|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571704|NCT00911547|B2|Baseline|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571705|NCT00911547|B1|Baseline|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571706|NCT00911547|P4|Participant Flow|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571707|NCT00911547|P3|Participant Flow|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571708|NCT00911547|P2|Participant Flow|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571709|NCT00911547|P1|Participant Flow|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571710|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571711|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571712|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571713|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571714|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571715|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571741|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
571716|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571717|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571718|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571719|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571720|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571721|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571722|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571723|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571724|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571725|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571726|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571727|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571728|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571729|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571730|NCT00911547|E4|Reported Event|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571731|NCT00911547|E3|Reported Event|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
571732|NCT00911547|E2|Reported Event|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571733|NCT00911547|E1|Reported Event|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
571734|NCT00911612|B3|Baseline|Total|Total of all reporting groups
571735|NCT00911612|B2|Baseline|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
571736|NCT00911612|B1|Baseline|Colesevelam|Participants received colesevelam 1.875 g twice daily
571737|NCT00911612|P2|Participant Flow|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
571738|NCT00911612|P1|Participant Flow|Colesevelam|Participants received colesevelam 1.875 g twice daily
571739|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
571740|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
571742|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
571743|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
571744|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
571745|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
571746|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
571747|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
571748|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
571749|NCT00911612|E2|Reported Event|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
571750|NCT00911612|E1|Reported Event|Colesevelam|Participants received colesevelam 1.875 g twice daily
571751|NCT00911625|B3|Baseline|Total|Total of all reporting groups
571752|NCT00911625|B2|Baseline|0.25 Units/kg|"Participants randomized to this arm will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.
0.25 units/kg daily insulin: Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine."
571753|NCT00911625|B1|Baseline|0.5 Units/kg|"Participants randomized to this arm will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.
0.5 units/kg daily insulin: Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine."
571754|NCT00911625|P2|Participant Flow|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
571755|NCT00911625|P1|Participant Flow|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
571756|NCT00911625|O2|Outcome|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
571757|NCT00911625|O1|Outcome|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
571758|NCT00911625|O2|Outcome|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
571759|NCT00911625|O1|Outcome|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
571760|NCT00911625|E2|Reported Event|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
571761|NCT00911625|E1|Reported Event|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
571762|NCT00911742|B3|Baseline|Total|Total of all reporting groups
571763|NCT00911742|B2|Baseline|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571764|NCT00911742|B1|Baseline|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571765|NCT00911742|P2|Participant Flow|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571766|NCT00911742|P1|Participant Flow|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571767|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571768|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571769|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571770|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571771|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571772|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571773|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571774|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571775|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
572675|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
571776|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571777|NCT00911742|E2|Reported Event|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571778|NCT00911742|E1|Reported Event|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.
OAD: Once-A-Day"
571779|NCT00911768|B3|Baseline|Total|Total of all reporting groups
571780|NCT00911768|B2|Baseline|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
571781|NCT00911768|B1|Baseline|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
571782|NCT00911768|P2|Participant Flow|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
571783|NCT00911768|P1|Participant Flow|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
571784|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
571785|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
571786|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
571787|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
571788|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
571789|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
571790|NCT00911768|E2|Reported Event|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
571791|NCT00911768|E1|Reported Event|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
571792|NCT00911807|B4|Baseline|Total|Total of all reporting groups
571793|NCT00911807|B3|Baseline|Donepezil|
571794|NCT00911807|B2|Baseline|Cerebrolysin|
571795|NCT00911807|B1|Baseline|Cerebrolysin + Donepezil|
571796|NCT00911807|P3|Participant Flow|Donepezil|
571797|NCT00911807|P2|Participant Flow|Cerebrolysin|
571798|NCT00911807|P1|Participant Flow|Cerebrolysin + Donepezil|
571799|NCT00911807|O3|Outcome|Donepezil|
571800|NCT00911807|O2|Outcome|Cerebrolysin|
571801|NCT00911807|O1|Outcome|Cerebrolysin + Donepezil|
571802|NCT00911807|E3|Reported Event|Donepezil|
571803|NCT00911807|E2|Reported Event|Cerebrolysin|
571804|NCT00911807|E1|Reported Event|Cerebrolysin + Donepezil|
571805|NCT00911859|B4|Baseline|Total|Total of all reporting groups
571806|NCT00911859|B3|Baseline|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571807|NCT00911859|B2|Baseline|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571808|NCT00911859|B1|Baseline|Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571809|NCT00911859|P3|Participant Flow|Part 2: VMP + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571810|NCT00911859|P2|Participant Flow|Part 2: VMP|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571811|NCT00911859|P1|Participant Flow|Part 1: VMP + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571812|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571813|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571814|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571815|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571816|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571817|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571818|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571819|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571820|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571821|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571822|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571823|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571824|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571825|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571826|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571827|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571828|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571829|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571830|NCT00911859|E4|Reported Event|Part 2, Maintenance Period: Siltuximab|Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period
571831|NCT00911859|E3|Reported Event|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571832|NCT00911859|E2|Reported Event|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571833|NCT00911859|E1|Reported Event|Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
571834|NCT00911898|B1|Baseline|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
571835|NCT00911898|P1|Participant Flow|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
571836|NCT00911898|O1|Outcome|MM-111|All participants
571837|NCT00911898|E1|Reported Event|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
571838|NCT00911937|B3|Baseline|Total|Total of all reporting groups
571839|NCT00911937|B2|Baseline|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571840|NCT00911937|B1|Baseline|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571841|NCT00911937|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571842|NCT00911937|P1|Participant Flow|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571843|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571844|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571845|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571846|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571847|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571848|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571849|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571850|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571851|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571852|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571853|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571854|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571855|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571856|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571857|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571858|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571859|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571860|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571861|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571862|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571863|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571864|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571865|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571866|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571867|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571868|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571869|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571870|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571871|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571872|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571873|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571874|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571875|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571876|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
572676|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
571877|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571878|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571879|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571880|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571881|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571882|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571883|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571884|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571885|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571886|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571887|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571888|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571889|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571890|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571891|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571892|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571893|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571894|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571895|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571896|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571897|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571898|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571899|NCT00911937|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
571900|NCT00911937|E1|Reported Event|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
571901|NCT00911989|B1|Baseline|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
571902|NCT00911989|P1|Participant Flow|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
571903|NCT00911989|O1|Outcome|Transvaginal Sleeve Gastrectomy|All subjects on whom the surgery was attempted.
571904|NCT00911989|E1|Reported Event|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
571905|NCT00912002|B1|Baseline|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
571906|NCT00912002|P1|Participant Flow|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
571907|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
571908|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
572677|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
571909|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes as eight 5-mg capsules.
571910|NCT00912002|E1|Reported Event|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
571911|NCT00912015|B5|Baseline|Total|Total of all reporting groups
571912|NCT00912015|B4|Baseline|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571913|NCT00912015|B3|Baseline|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571914|NCT00912015|B2|Baseline|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571915|NCT00912015|B1|Baseline|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571916|NCT00912015|P4|Participant Flow|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571917|NCT00912015|P3|Participant Flow|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571918|NCT00912015|P2|Participant Flow|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571919|NCT00912015|P1|Participant Flow|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571920|NCT00912015|O4|Outcome|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571921|NCT00912015|O3|Outcome|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571922|NCT00912015|O2|Outcome|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571923|NCT00912015|O1|Outcome|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571924|NCT00912015|E4|Reported Event|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571925|NCT00912015|E3|Reported Event|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571926|NCT00912015|E2|Reported Event|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571927|NCT00912015|E1|Reported Event|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day."
571928|NCT00912028|B4|Baseline|Total|Total of all reporting groups
571929|NCT00912028|B3|Baseline|Methafilcon A|"contact lens
methafilcon A: contact lens"
571930|NCT00912028|B2|Baseline|Balafilcon A|"contact lens
balafilcon A: contact lens"
571931|NCT00912028|B1|Baseline|Senofilcon A|"contact lens
senofilcon A: contact lens"
571932|NCT00912028|P5|Participant Flow|Vifilcon A|"contact lens
vifilcon A: contact lens"
571933|NCT00912028|P4|Participant Flow|Methafilcon A|"contact lens
methafilcon A: contact lens"
571934|NCT00912028|P3|Participant Flow|Balafilcon A|"contact lens
balafilcon A: contact lens"
571935|NCT00912028|P2|Participant Flow|Lotrafilcon B|"contact lens
lotrafilcon B: contact lens"
571936|NCT00912028|P1|Participant Flow|Senofilcon A|"contact lens
senofilcon A: contact lens"
571937|NCT00912028|O3|Outcome|Methafilcon A|"contact lens
methafilcon A: contact lens"
571938|NCT00912028|O2|Outcome|Balafilcon A|"contact lens
balafilcon A: contact lens"
571939|NCT00912028|O1|Outcome|Senofilcon A|"contact lens
senofilcon A: contact lens"
571940|NCT00912028|O3|Outcome|Methafilcon A|"contact lens
methafilcon A: contact lens"
571941|NCT00912028|O2|Outcome|Balafilcon A|"contact lens
balafilcon A: contact lens"
571942|NCT00912028|O1|Outcome|Senofilcon A|"contact lens
senofilcon A: contact lens"
571943|NCT00912028|O3|Outcome|Methafilcon A|"contact lens
methafilcon A: contact lens"
571944|NCT00912028|O2|Outcome|Balafilcon A|"contact lens
balafilcon A: contact lens"
571945|NCT00912028|O1|Outcome|Senofilcon A|"contact lens
senofilcon A: contact lens"
571946|NCT00912028|O3|Outcome|Methafilcon A|"contact lens
methafilcon A: contact lens"
571947|NCT00912028|O2|Outcome|Balafilcon A|"contact lens
balafilcon A: contact lens"
571948|NCT00912028|O1|Outcome|Senofilcon A|"contact lens
senofilcon A: contact lens"
571949|NCT00912028|O3|Outcome|Methafilcon A|"contact lens
methafilcon A: contact lens"
571950|NCT00912028|O2|Outcome|Balafilcon A|"contact lens
balafilcon A: contact lens"
571951|NCT00912028|O1|Outcome|Senofilcon A|"contact lens
senofilcon A: contact lens"
571952|NCT00912028|O3|Outcome|Methafilcon A|"contact lens
methafilcon A: contact lens"
571953|NCT00912028|O2|Outcome|Balafilcon A|"contact lens
balafilcon A: contact lens"
571954|NCT00912028|O1|Outcome|Senofilcon A|"contact lens
senofilcon A: contact lens"
571955|NCT00912028|E5|Reported Event|Vifilcon A|"contact lens
vifilcon A: contact lens"
571956|NCT00912028|E4|Reported Event|Methafilcon A|"contact lens
methafilcon A: contact lens"
571957|NCT00912028|E3|Reported Event|Balafilcon A|"contact lens
balafilcon A: contact lens"
571958|NCT00912028|E2|Reported Event|Lotrafilcon B|"contact lens
lotrafilcon B: contact lens"
571959|NCT00912028|E1|Reported Event|Senofilcon A|"contact lens
senofilcon A: contact lens"
571960|NCT00912093|B6|Baseline|Total|Total of all reporting groups
571961|NCT00912093|B5|Baseline|Open-Label Icatibant-Severe Laryngeal|Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant 30 mg in the controlled phase
571962|NCT00912093|B4|Baseline|Randomized-Placebo (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
571963|NCT00912093|B3|Baseline|Randomized-Icatibant (Blinded Treatment)--Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
572179|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
571964|NCT00912093|B2|Baseline|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
571965|NCT00912093|B1|Baseline|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
571966|NCT00912093|P5|Participant Flow|Open-Label Icatibant-Severe Laryngeal|Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant, 30 mg in the controlled phase
571967|NCT00912093|P4|Participant Flow|Randomized-Placebo (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
571968|NCT00912093|P3|Participant Flow|Randomized-Icatibant (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
571969|NCT00912093|P2|Participant Flow|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
571970|NCT00912093|P1|Participant Flow|Randomized-Icatibant (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
571971|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
571972|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
571973|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
571974|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
571975|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
571976|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
571977|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
571978|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
571979|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
571980|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
571981|NCT00912093|E4|Reported Event|Open Label Extension – Icatibant (Open Label)|Subjects who treated with icatibant 30 mg in the open label extension phase
571982|NCT00912093|E3|Reported Event|Controlled Phase - Icatibant (Open Label)|Subjects who were not randomized and received a single subcutaneous injection of icatibant 30 mg in the controlled phase
571983|NCT00912093|E2|Reported Event|Controlled Phase -Placebo (Randomized)|Subjects who were randomized to treatment and received a single subcutaneous injection of matching placebo in the controlled phase
571984|NCT00912093|E1|Reported Event|Controlled Phase - Icatibant (Randomized)|Subjects who were randomized to treatment and received a single subcutaneous injection of icatibant 30 mg in the controlled phase
571985|NCT00912158|B4|Baseline|Total|Total of all reporting groups
571986|NCT00912158|B3|Baseline|Standard Treatment|Standard medical therapy alone
571987|NCT00912158|B2|Baseline|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
571988|NCT00912158|B1|Baseline|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
571989|NCT00912158|P3|Participant Flow|Standard Treatment|Standard medical therapy alone
571990|NCT00912158|P2|Participant Flow|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
571991|NCT00912158|P1|Participant Flow|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
571992|NCT00912158|O3|Outcome|Standard Treatment|Standard medical therapy alone
571993|NCT00912158|O2|Outcome|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
571994|NCT00912158|O1|Outcome|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
571995|NCT00912223|B1|Baseline|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
571996|NCT00912223|P1|Participant Flow|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
571997|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
571998|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
571999|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572000|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572001|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572002|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572003|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572004|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572005|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572006|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572007|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572008|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572009|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572010|NCT00912223|E1|Reported Event|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
572011|NCT00912288|B3|Baseline|Total|Total of all reporting groups
572012|NCT00912288|B2|Baseline|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572013|NCT00912288|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572014|NCT00912288|P2|Participant Flow|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572015|NCT00912288|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572016|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572017|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572018|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572019|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572020|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572021|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572022|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572023|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572024|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572025|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572026|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572027|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572028|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572029|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572030|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572031|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572032|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572180|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572033|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572034|NCT00912288|E2|Reported Event|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
572035|NCT00912288|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
572036|NCT00912301|B4|Baseline|Total|Total of all reporting groups
572037|NCT00912301|B3|Baseline|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
572038|NCT00912301|B2|Baseline|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
572039|NCT00912301|B1|Baseline|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
572040|NCT00912301|P3|Participant Flow|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
572041|NCT00912301|P2|Participant Flow|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
572042|NCT00912301|P1|Participant Flow|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
572043|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
572044|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
572045|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
572046|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
572047|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
572048|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
572049|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
572050|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
572051|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
572052|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
572053|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
572054|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
572055|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
572056|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
572057|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
572058|NCT00912301|E3|Reported Event|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
572059|NCT00912301|E2|Reported Event|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
572060|NCT00912301|E1|Reported Event|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
572061|NCT00912405|B1|Baseline|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint
Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
572062|NCT00912405|P1|Participant Flow|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint
Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
572063|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint
Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
572064|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint
Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
572065|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint
Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
572066|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint
Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
572067|NCT00912405|E1|Reported Event|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint
Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
572068|NCT00912509|B3|Baseline|Total|Total of all reporting groups
572069|NCT00912509|B2|Baseline|45 Minute Light Duration|"45 minute treatment with UVX light
riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes
UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
572070|NCT00912509|B1|Baseline|30 Minute Light Duration|"30 minute treatment with UVX light
riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes
UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
572071|NCT00912509|P2|Participant Flow|45 Minute Light Duration|"45 minute treatment with UVX light
UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
572072|NCT00912509|P1|Participant Flow|30 Minute Light Duration|"30 minute treatment with UVX light
riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes
UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
572073|NCT00912509|O2|Outcome|45 Minute Light Duration|"45 minute treatment with UVX light
UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
572074|NCT00912509|O1|Outcome|30 Minute Light Duration|"30 minute treatment with UVX light
UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
572075|NCT00912509|E2|Reported Event|45 Minute Light Duration|"45 minute treatment with UVX light
UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
572076|NCT00912509|E1|Reported Event|30 Minute Light Duration|"30 minute treatment with UVX light
UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
572077|NCT00912743|B3|Baseline|Total|Total of all reporting groups
572078|NCT00912743|B2|Baseline|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
572079|NCT00912743|B1|Baseline|MSI-H|MSI-H group receiving olaparib 400mg BID
572080|NCT00912743|P2|Participant Flow|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
572081|NCT00912743|P1|Participant Flow|MSI-H|MSI-H group receiving olaparib 400mg BID
572082|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
572083|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
572084|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
572085|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
572086|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
572087|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
572088|NCT00912743|E2|Reported Event|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
572089|NCT00912743|E1|Reported Event|MSI-H|MSI-H group receiving olaparib 400mg BID
572090|NCT00912782|B3|Baseline|Total|Total of all reporting groups
572091|NCT00912782|B2|Baseline|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
572092|NCT00912782|B1|Baseline|Placebo|Placebo one time per week for 3 weeks
572093|NCT00912782|P2|Participant Flow|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
572094|NCT00912782|P1|Participant Flow|Placebo|Placebo one time per week for 3 weeks
572095|NCT00912782|O2|Outcome|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
572096|NCT00912782|O1|Outcome|Placebo|Placebo one time per week for 3 weeks
572097|NCT00912782|O2|Outcome|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
572098|NCT00912782|O1|Outcome|Placebo|Placebo one time per week for 3 weeks
572099|NCT00912782|E2|Reported Event|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
572100|NCT00912782|E1|Reported Event|Placebo|Placebo one time per week for 3 weeks
572101|NCT00912795|B3|Baseline|Total|Total of all reporting groups
572102|NCT00912795|B2|Baseline|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.
The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
572103|NCT00912795|B1|Baseline|SMS Turkey|"6-week smoking cessation program delivered via daily text messages
SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.
Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.
Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
572104|NCT00912795|P2|Participant Flow|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.
The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
572105|NCT00912795|P1|Participant Flow|SMS Turkey|"6-week smoking cessation program delivered via daily text messages
SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.
Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.
Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
572106|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.
The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
572107|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages
SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.
Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.
Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
572108|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.
The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
572137|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
572109|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages
SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.
Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.
Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
572110|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.
The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
572111|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages
SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.
Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.
Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
572112|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.
The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
572113|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages
SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.
Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.
Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
572114|NCT00912795|E2|Reported Event|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.
The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
572115|NCT00912795|E1|Reported Event|SMS Turkey|"6-week smoking cessation program delivered via daily text messages
SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.
Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.
Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
572116|NCT00912808|B3|Baseline|Total|Total of all reporting groups
572117|NCT00912808|B2|Baseline|Sugar Pill|
572118|NCT00912808|B1|Baseline|Donepezil|
572119|NCT00912808|P2|Participant Flow|Sugar Pill|
572120|NCT00912808|P1|Participant Flow|Donepezil|
572121|NCT00912808|O2|Outcome|Sugar Pill|
572122|NCT00912808|O1|Outcome|Donepezil|
572123|NCT00912808|O2|Outcome|Sugar Pill|
572124|NCT00912808|O1|Outcome|Donepezil|
572125|NCT00912808|E2|Reported Event|Sugar Pill|
572126|NCT00912808|E1|Reported Event|Donepezil|
572127|NCT00912912|B1|Baseline|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
572128|NCT00912912|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
572129|NCT00912912|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
572130|NCT00912912|E1|Reported Event|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
572131|NCT00912925|B3|Baseline|Total|Total of all reporting groups
572132|NCT00912925|B2|Baseline|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
572133|NCT00912925|B1|Baseline|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
572134|NCT00912925|P2|Participant Flow|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
572135|NCT00912925|P1|Participant Flow|Placebo|Patients in the placebo-control group were administered a solution of 100 millimolar (mM) sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
572136|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
572351|NCT00920907|B3|Baseline|Total|Total of all reporting groups
572138|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
572139|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
572140|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
572141|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
572142|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
572143|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
572144|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
572145|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
572146|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
572147|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
572148|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
572149|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
572150|NCT00912925|E2|Reported Event|Aldurazyme***Check Title***|Aldurazyme***Check Description***
572151|NCT00912925|E1|Reported Event|Placebo***Check Title***|Placebo***Check Description***
572152|NCT00912964|B4|Baseline|Total|Total of all reporting groups
572153|NCT00912964|B3|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572154|NCT00912964|B2|Baseline|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572155|NCT00912964|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572156|NCT00912964|P3|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572157|NCT00912964|P2|Participant Flow|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572158|NCT00912964|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572159|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572160|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572161|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572162|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572163|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572164|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572165|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572166|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572167|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572168|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572169|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572170|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572171|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572172|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572173|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572174|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572175|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572176|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572177|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572178|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572181|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572182|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572183|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572184|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572185|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572186|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572187|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572188|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572189|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572190|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572191|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572192|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572193|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572194|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572195|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572196|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572197|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572198|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572199|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572200|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572201|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572202|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572203|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572204|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572205|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572206|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572207|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572208|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572209|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572210|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572211|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572212|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572213|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572214|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572215|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572216|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572217|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572218|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572219|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572220|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572221|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572222|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572223|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572224|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572225|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572226|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572227|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572228|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572229|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572230|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572231|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572232|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572233|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572234|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572235|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572236|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572237|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572238|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572239|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572240|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572241|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572242|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572243|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572244|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572245|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572246|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572247|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572248|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572249|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572250|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572251|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572252|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572253|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572254|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572255|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572256|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572257|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572258|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572259|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572260|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572261|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572262|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572263|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572264|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572265|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572266|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572267|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572268|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572269|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572270|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572271|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572272|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572273|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572274|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572275|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572276|NCT00912964|E3|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
572277|NCT00912964|E2|Reported Event|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
572278|NCT00912964|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
572279|NCT00920816|B5|Baseline|Total|Total of all reporting groups
572280|NCT00920816|B4|Baseline|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572281|NCT00920816|B3|Baseline|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572282|NCT00920816|B2|Baseline|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572283|NCT00920816|B1|Baseline|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572284|NCT00920816|P4|Participant Flow|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572285|NCT00920816|P3|Participant Flow|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572286|NCT00920816|P2|Participant Flow|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572287|NCT00920816|P1|Participant Flow|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572288|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572289|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572290|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572291|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572292|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572293|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572294|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572295|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572296|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572297|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572298|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572299|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572300|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572301|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572678|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572679|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572302|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572303|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572304|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572305|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572306|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572307|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572308|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572309|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572310|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572311|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572312|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572313|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572314|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572315|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572316|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572317|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572318|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572319|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572320|NCT00920816|E4|Reported Event|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572321|NCT00920816|E3|Reported Event|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572680|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572681|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572322|NCT00920816|E2|Reported Event|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572323|NCT00920816|E1|Reported Event|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
572324|NCT00920855|B4|Baseline|Total|Total of all reporting groups
572325|NCT00920855|B3|Baseline|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572326|NCT00920855|B2|Baseline|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572327|NCT00920855|B1|Baseline|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572328|NCT00920855|P3|Participant Flow|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572329|NCT00920855|P2|Participant Flow|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572330|NCT00920855|P1|Participant Flow|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572331|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572332|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572333|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572334|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
572335|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
572336|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
572337|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
572338|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
572339|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572340|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572341|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572342|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572343|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572344|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572345|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572346|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572347|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572348|NCT00920855|E3|Reported Event|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572349|NCT00920855|E2|Reported Event|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572350|NCT00920855|E1|Reported Event|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
572352|NCT00920907|B2|Baseline|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572353|NCT00920907|B1|Baseline|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572354|NCT00920907|P2|Participant Flow|Ipilimumab (Process C)|Intravenous (IV) solution of 10 milligrams (mg)ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572355|NCT00920907|P1|Participant Flow|Ipilimumab (Process B)|Intravenous (IV) solution of 10 milligrams (mg) ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by the Lonza company using material from transfectoma cell line.
572356|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572357|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572358|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572359|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572360|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572361|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572362|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572363|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572364|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572365|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572366|NCT00920907|O2|Outcome|Ipilimumab (Process C)|Intravenous (IV) solution of 10 milligrams (mg)ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572367|NCT00920907|O1|Outcome|Ipilimumab (Process B)|Intravenous (IV) solution of 10 milligrams (mg) ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by the Lonza company using material from transfectoma cell line.
572368|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572369|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572389|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572370|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572371|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572372|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572373|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572374|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572375|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572376|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572377|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572378|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572379|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572380|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572381|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572382|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572383|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572384|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572385|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572386|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572387|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572388|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572461|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
572390|NCT00920907|E2|Reported Event|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
572391|NCT00920907|E1|Reported Event|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
572392|NCT00921024|B3|Baseline|Total|Total of all reporting groups
572393|NCT00921024|B2|Baseline|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
572394|NCT00921024|B1|Baseline|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
572395|NCT00921024|P2|Participant Flow|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
572396|NCT00921024|P1|Participant Flow|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
572397|NCT00921024|O2|Outcome|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
572398|NCT00921024|O1|Outcome|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
572399|NCT00921024|O2|Outcome|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
572400|NCT00921024|O1|Outcome|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
572401|NCT00921024|E2|Reported Event|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
572402|NCT00921024|E1|Reported Event|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
572403|NCT00921115|B1|Baseline|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.
On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.
Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
572404|NCT00921115|P1|Participant Flow|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.
On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.
Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
572405|NCT00921115|O1|Outcome|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.
On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.
Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
572406|NCT00921115|E1|Reported Event|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.
On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.
Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
572407|NCT00923091|B9|Baseline|Total|Total of all reporting groups
572408|NCT00923091|B8|Baseline|Olmesartan/Amlodipine 40mg/10mg|
572409|NCT00923091|B7|Baseline|Olmesartan/Amlodipine 40mg/5mg|
572410|NCT00923091|B6|Baseline|Olmesartan/Amlodipine 20mg/5mg|
572411|NCT00923091|B5|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|
572412|NCT00923091|B4|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|
572413|NCT00923091|B3|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|
572414|NCT00923091|B2|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|
572415|NCT00923091|B1|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|
572416|NCT00923091|P13|Participant Flow|20/5/12.5mg Responder Continued on 20/5/12.5 mg|In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg continued on 20mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
572417|NCT00923091|P12|Participant Flow|OM/AML/HCT 20/5/12.5mg NonResponder Up Titrated to 40/5/12.5mg|In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg were up titrated to 40mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
572682|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572418|NCT00923091|P11|Participant Flow|OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/25mg|In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
572419|NCT00923091|P10|Participant Flow|OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/12.5mg|In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
572420|NCT00923091|P9|Participant Flow|OM/AML/HCT 40/5/12.5mg Responder Continued on 40/5/12.5 mg|In Period V responders continued on olmesartan/amlodipine/ hydrochlorothiazide 40mg/5mg/12.5 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
572421|NCT00923091|P8|Participant Flow|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
572422|NCT00923091|P7|Participant Flow|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
572423|NCT00923091|P6|Participant Flow|Olmesartan(OM)20mg/Amlodipine (AML)5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
572424|NCT00923091|P5|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide(HCT) 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
572425|NCT00923091|P4|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
572426|NCT00923091|P3|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
572427|NCT00923091|P2|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period IV participants who did not meet the blood pressure goals (<140/90 mm Hg; or <130/80 for participants with diabetes or chronic renal or cardiovascular disease)in Period III were randomized in a 1:2 fashion to OLM/AML/HCTZ 20/5/12.5 or this group.
572428|NCT00923091|P1|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period III, all participants were included in this group. Responders (a participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease) in Period III went directly to Period VI. In Period IV participants who did not meet the blood pressure goals in Period III were randomized in a 1:2 fashion to this group or the OLM/AML/HCTZ 40/5/12.5 group.
572429|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/25 Titrated to 40/10/25|The participants in this arm had their study medication titrated from olmesartan\amlodipine\hydrochlorothiazide 40/5/25 to 40/10/25
572430|NCT00923091|O2|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
572431|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
572432|NCT00923091|O2|Outcome|OLM/AML/HCTZ40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
572433|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
572434|NCT00923091|O2|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
572435|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
572436|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.
hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
572462|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
572683|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572684|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572437|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.
hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
572438|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.
hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
572439|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.
hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
572440|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet.
Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
572441|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.
hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
572442|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
572443|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
572444|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
572445|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
572446|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
572447|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
572448|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
572449|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
572450|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
572451|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
572452|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
572453|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
572454|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
572455|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
572456|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
572457|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
572458|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
572459|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
572460|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
572543|NCT00923247|B3|Baseline|Total|Total of all reporting groups
572685|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572463|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
572464|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
572465|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
572466|NCT00923091|E8|Reported Event|Olmesartan/Amlodipine 40mg/10mg|
572467|NCT00923091|E7|Reported Event|Olmesartan/Amlodipine 40mg/5mg|
572468|NCT00923091|E6|Reported Event|Olmesartan/Amlodipine 20mg/5mg|
572469|NCT00923091|E5|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|
572470|NCT00923091|E4|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|
572471|NCT00923091|E3|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|
572472|NCT00923091|E2|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|
572473|NCT00923091|E1|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|
572474|NCT00923117|B3|Baseline|Total|Total of all reporting groups
572475|NCT00923117|B2|Baseline|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
572476|NCT00923117|B1|Baseline|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
572477|NCT00923117|P2|Participant Flow|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
572478|NCT00923117|P1|Participant Flow|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab. Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
572479|NCT00923117|O2|Outcome|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
572480|NCT00923117|O1|Outcome|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
572481|NCT00923117|O2|Outcome|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
572482|NCT00923117|O1|Outcome|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
572483|NCT00923117|E2|Reported Event|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
572484|NCT00923117|E1|Reported Event|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
572485|NCT00923130|B1|Baseline|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572486|NCT00923130|P1|Participant Flow|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572487|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572488|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572489|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572490|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572491|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572592|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572492|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572493|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572494|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572495|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572496|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572497|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572498|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572499|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572500|NCT00923130|E1|Reported Event|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
572501|NCT00923156|B4|Baseline|Total|Total of all reporting groups
572502|NCT00923156|B3|Baseline|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
572503|NCT00923156|B2|Baseline|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
572504|NCT00923156|B1|Baseline|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572505|NCT00923156|P3|Participant Flow|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
572593|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572594|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572506|NCT00923156|P2|Participant Flow|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
572507|NCT00923156|P1|Participant Flow|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572508|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572509|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572510|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572511|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572512|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572513|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572514|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
572515|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
572516|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572517|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
572518|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
572519|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572520|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
572595|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572521|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
572522|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572523|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
572524|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
572525|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572526|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
572527|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
572528|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572529|NCT00923156|E3|Reported Event|Ramipril + Aliskiren|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
572530|NCT00923156|E2|Reported Event|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
572531|NCT00923156|E1|Reported Event|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.
In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
572532|NCT00923195|B3|Baseline|Total|Total of all reporting groups
572533|NCT00923195|B2|Baseline|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
572534|NCT00923195|B1|Baseline|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
572596|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572597|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572598|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572599|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572535|NCT00923195|P2|Participant Flow|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
572536|NCT00923195|P1|Participant Flow|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
572537|NCT00923195|O2|Outcome|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
572538|NCT00923195|O1|Outcome|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
572539|NCT00923195|O2|Outcome|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
572540|NCT00923195|O1|Outcome|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
572541|NCT00923195|E2|Reported Event|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
572542|NCT00923195|E1|Reported Event|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
572544|NCT00923247|B2|Baseline|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572545|NCT00923247|B1|Baseline|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572546|NCT00923247|P2|Participant Flow|Phase 2 A - Vandetanib and Bortezomib at the MTD|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572547|NCT00923247|P1|Participant Flow|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572548|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572549|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572550|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572551|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572552|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572553|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572554|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572555|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572556|NCT00923247|O2|Outcome|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572557|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572558|NCT00923247|O2|Outcome|Phase 2A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572600|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572601|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572602|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572603|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572559|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572560|NCT00923247|O2|Outcome|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572561|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572562|NCT00923247|O2|Outcome|Phase 2A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572563|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572564|NCT00923247|O2|Outcome|Phase 2A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572565|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572566|NCT00923247|O1|Outcome|Phase 2 A - Vandetanib and Bortezomib at the MTD|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572567|NCT00923247|O1|Outcome|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572568|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572569|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib to find the maximally tolerated dose.
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib on days 1, 4, 8 & 11 every 28 days in adults"
572570|NCT00923247|E2|Reported Event|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572571|NCT00923247|E1|Reported Event|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos
Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
572572|NCT00923260|B3|Baseline|Total|Total of all reporting groups
572573|NCT00923260|B2|Baseline|Roux-en-Y Gastric Bypass Alone|
572574|NCT00923260|B1|Baseline|Roux-en-Y Gastric Bypass/Omentectomy|
572575|NCT00923260|P2|Participant Flow|Roux-en-Y Gastric Bypass Alone|
572576|NCT00923260|P1|Participant Flow|Roux-en-Y Gastric Bypass/Omentectomy|
572577|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572578|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572579|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572580|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572581|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572582|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572583|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572584|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572585|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572586|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572587|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572588|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572589|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572590|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
572591|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
572708|NCT00923273|B5|Baseline|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
572709|NCT00923273|B4|Baseline|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
572710|NCT00923273|B3|Baseline|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
572711|NCT00923273|B2|Baseline|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
572712|NCT00923273|B1|Baseline|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
572713|NCT00923273|P5|Participant Flow|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
572714|NCT00923273|P4|Participant Flow|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
572715|NCT00923273|P3|Participant Flow|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
572716|NCT00923273|P2|Participant Flow|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
572717|NCT00923273|P1|Participant Flow|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
572718|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
572719|NCT00923273|O4|Outcome|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
572720|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
572721|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
572722|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
572723|NCT00923273|O1|Outcome|Treatment Level 4: 10mg Load|"Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
Includes 8 subjects with prior peme; 12 subjects who were peme naive;and 7 subjects rolled over from ph I"
572724|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
572725|NCT00923273|O4|Outcome|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
572726|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
572727|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
572728|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
572729|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
572730|NCT00923273|O4|Outcome|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
572731|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
572732|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
572733|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
572734|NCT00923273|E5|Reported Event|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
572735|NCT00923273|E4|Reported Event|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
572736|NCT00923273|E3|Reported Event|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
572737|NCT00923273|E2|Reported Event|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
572738|NCT00923273|E1|Reported Event|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
572739|NCT00923351|B3|Baseline|Total|Total of all reporting groups
572750|NCT00923351|E1|Reported Event|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
572751|NCT00923481|B1|Baseline|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
572740|NCT00923351|B2|Baseline|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).
Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
572741|NCT00923351|B1|Baseline|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
572742|NCT00923351|P3|Participant Flow|Enrolled But Not Assigned to Treatment|Twelve participants were not treated in Arm A or Arm B because they did not get far enough in the study to be designated for an Arm. Were unable to obtain apheresis, and adequate tumor samples.
572762|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572743|NCT00923351|P2|Participant Flow|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose subcutaneous (SQ) (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).
Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
572744|NCT00923351|P1|Participant Flow|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participant will receive Tumor lysate/keyhole limpet hemocyanin (KLH) pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
572745|NCT00923351|O2|Outcome|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).
Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
572746|NCT00923351|O1|Outcome|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
572747|NCT00923351|O2|Outcome|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).
Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
572748|NCT00923351|O1|Outcome|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
572749|NCT00923351|E2|Reported Event|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).
Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
572752|NCT00923481|P1|Participant Flow|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
573236|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
572753|NCT00923481|O1|Outcome|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
572754|NCT00923481|O1|Outcome|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
572755|NCT00923481|E1|Reported Event|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
572756|NCT00923845|B3|Baseline|Total|Total of all reporting groups
572757|NCT00923845|B2|Baseline|Recipients|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572758|NCT00923845|B1|Baseline|Donors|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
572759|NCT00923845|P2|Participant Flow|Recipients|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572760|NCT00923845|P1|Participant Flow|Donors|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
572761|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572848|NCT00924053|B2|Baseline|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572763|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572764|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572765|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572766|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572767|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572768|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572769|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572770|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572771|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572772|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572773|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572774|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572775|NCT00923845|O2|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572776|NCT00923845|O1|Outcome|Donor|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
572777|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572778|NCT00923845|E2|Reported Event|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
572779|NCT00923845|E1|Reported Event|Donor|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
572780|NCT00923910|B3|Baseline|Total|Total of all reporting groups
572781|NCT00923910|B2|Baseline|Recipients|Vaccine and donor lymphocyte prep
572782|NCT00923910|B1|Baseline|Donors|Donor lymphocyte collection via apheresis.
572783|NCT00923910|P2|Participant Flow|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
572784|NCT00923910|P1|Participant Flow|Donors|Period 1 -Donor lymphocyte collection via apheresis. Period 2 -Donor cell processing for vaccine and infusion.
572785|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
572786|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
572787|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
572788|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
572789|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
572790|NCT00923910|O1|Outcome|Recipients|Vaccine and donor lymphocyte prep
572791|NCT00923910|O1|Outcome|Recipients|Vaccine and donor lymphocyte prep
572792|NCT00923910|E1|Reported Event|Recipients|Vaccine and donor lymphocyte prep
572793|NCT00923936|B3|Baseline|Total|Total of all reporting groups
572794|NCT00923936|B2|Baseline|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572795|NCT00923936|B1|Baseline|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
573237|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
572796|NCT00923936|P2|Participant Flow|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572797|NCT00923936|P1|Participant Flow|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572849|NCT00924053|B1|Baseline|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572850|NCT00924053|P4|Participant Flow|EGT0001474 150mg|Received six 25 mg capsules once daily.
572851|NCT00924053|P3|Participant Flow|EGT0001474 75 mg|Received three 25mg capsules once daily.
572852|NCT00924053|P2|Participant Flow|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572798|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572799|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2^ and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572800|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572801|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572802|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572803|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2^ and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572804|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572805|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572806|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572839|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
572840|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
573238|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
572807|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572808|NCT00923936|E2|Reported Event|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572809|NCT00923936|E1|Reported Event|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.
Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
572810|NCT00923949|B1|Baseline|Pioglitazone|45 mg tablet daily by mouth for six weeks
572811|NCT00923949|P1|Participant Flow|Pioglitazone|45 mg tablet daily by mouth for six weeks
572812|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
572813|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
572814|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
572815|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
572816|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
572817|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
572818|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
572819|NCT00923949|E1|Reported Event|Pioglitazone|45 mg tablet daily by mouth for six weeks
572820|NCT00923975|B1|Baseline|Intended Users of the Software|Baseline measures were analyzed using only data for the young adults (18-24 years of age) and parents/guardians (18 to 47 years of age) of children with diabetes, not healthcare professionals. Data was not used from one subject withdrawn from the study because the subject did not meet inclusion criteria.
572821|NCT00923975|P1|Participant Flow|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
572822|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
572823|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
572824|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
572825|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
572826|NCT00923975|E1|Reported Event|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
572827|NCT00924001|B1|Baseline|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
572828|NCT00924001|P1|Participant Flow|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
572829|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
572830|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
572831|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
572832|NCT00924001|E1|Reported Event|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
572833|NCT00924040|B1|Baseline|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
572834|NCT00924040|P1|Participant Flow|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
572835|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
572836|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
572837|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
572838|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
572841|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
572842|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
572843|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
572844|NCT00924040|E1|Reported Event|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
572845|NCT00924053|B5|Baseline|Total|Total of all reporting groups
572846|NCT00924053|B4|Baseline|EGT0001474 150mg|Received six 25 mg capsules once daily.
572847|NCT00924053|B3|Baseline|EGT0001474 75 mg|Received three 25mg capsules once daily.
572853|NCT00924053|P1|Participant Flow|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572854|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
572855|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
572856|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572857|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572858|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
572859|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
572860|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572861|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572862|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
572863|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
572864|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572865|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572866|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
572867|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
572868|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572869|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572870|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
572871|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
572872|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572873|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572874|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
572875|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
572876|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572877|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572878|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
572879|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
572880|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572881|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572882|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
572883|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
572884|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572885|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572886|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
572887|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
572888|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572889|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572890|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
572891|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
572892|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572893|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572894|NCT00924053|E4|Reported Event|EGT0001474 150mg|Received six 25 mg capsules once daily.
572895|NCT00924053|E3|Reported Event|EGT0001474 75 mg|Received three 25mg capsules once daily.
572896|NCT00924053|E2|Reported Event|EGT0001474 25 mg|Received one 25 mg capsule once daily.
572897|NCT00924053|E1|Reported Event|Placebo|Received 1, 3, or 6 placebo capsules once daily.
572898|NCT00924066|B1|Baseline|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.
Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.
All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
573020|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
572899|NCT00924066|P1|Participant Flow|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.
Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.
All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
572900|NCT00924066|O1|Outcome|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.
Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.
All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
572901|NCT00924066|O1|Outcome|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.
Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes. All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
573027|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
572902|NCT00924066|E1|Reported Event|Adverse Events for Squamous and Non-squamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.
Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.
All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
572903|NCT00924209|B1|Baseline|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
572904|NCT00924209|P1|Participant Flow|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
572905|NCT00924209|O1|Outcome|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
572906|NCT00924209|O1|Outcome|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
572907|NCT00924209|E1|Reported Event|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
572908|NCT00924287|B1|Baseline|Metastatic Cancer|Cancer that has invaded other parts of the body
572909|NCT00924287|P1|Participant Flow|Metastatic Cancer|Cancer that has invaded other parts of the body
572910|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
572911|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
572912|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
572913|NCT00924287|E1|Reported Event|Metastatic Cancer|Cancer that has invaded other parts of the body
572914|NCT00924313|B1|Baseline|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572915|NCT00924313|P1|Participant Flow|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572916|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572917|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572918|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572919|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572920|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572921|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572922|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572923|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572924|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572925|NCT00924313|E1|Reported Event|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
572926|NCT00924352|B1|Baseline|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
572927|NCT00924352|P2|Participant Flow|Phase II|The Phase II sample includes patients who were enrolled into the Phase II portion of this study. Dasatinib and ixabepilone were administered at the maximum tolerated dose determined during the Phase I portion: dasatinib 100 mg daily and ixabepilone 20 mg/m2. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
572928|NCT00924352|P1|Participant Flow|Phase I|The Phase I sample includes patients who were enrolled into the Phase I portion of this study. Patients received treatment according to the assigned dose level. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
572929|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
572930|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
572931|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
572932|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
572933|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
572934|NCT00924352|O3|Outcome|Ixabepilone + Dasatinib (Dose Level 2)|Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
572935|NCT00924352|O2|Outcome|Ixabepilone + Dasatinib (Dose Level 1)|Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
572936|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib (Dose Level 0)|Dasatinib 100 mg daily and Ixabepilone 16 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
573051|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
572937|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
572963|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
573028|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573132|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
572938|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
572939|NCT00924352|E1|Reported Event|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
572940|NCT00924404|B3|Baseline|Total|Total of all reporting groups
572941|NCT00924404|B2|Baseline|Saline|"saline for sinus rinse
Saline: saline for sinus rinse"
572942|NCT00924404|B1|Baseline|Xylitol|"isotonic xylitol for sinus rinse
Xylitol: 5% solution for sinus rinse"
572943|NCT00924404|P2|Participant Flow|Saline|"saline for sinus rinse
Saline: saline for sinus rinse"
572944|NCT00924404|P1|Participant Flow|Xylitol|"isotonic xylitol for sinus rinse
Xylitol: 5% solution for sinus rinse"
572945|NCT00924404|O2|Outcome|Saline|"saline for sinus rinse
Saline: saline for sinus rinse"
572946|NCT00924404|O1|Outcome|Xylitol|"isotonic xylitol for sinus rinse
Xylitol: 5% solution for sinus rinse"
572947|NCT00924404|E2|Reported Event|Saline|"saline for sinus rinse
Saline: saline for sinus rinse"
572948|NCT00924404|E1|Reported Event|Xylitol|"isotonic xylitol for sinus rinse
Xylitol: 5% solution for sinus rinse"
572949|NCT00924443|B1|Baseline|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
572950|NCT00924443|P1|Participant Flow|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days
572951|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
572952|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
572953|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
572954|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
572955|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
572956|NCT00924443|E1|Reported Event|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days(one cycle) and 20 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for second and subsequent cycles,up to a maximum of 3 cycles.
572957|NCT00924469|B3|Baseline|Total|Total of all reporting groups
572958|NCT00924469|B2|Baseline|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
572959|NCT00924469|B1|Baseline|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
572960|NCT00924469|P2|Participant Flow|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
573087|NCT00924781|B1|Baseline|MK2578 1mcg/600U QW|MK2578 IV administered QW.
572961|NCT00924469|P1|Participant Flow|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
572962|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
573133|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
572964|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
572965|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
572966|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
572967|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
572968|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
572969|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
572970|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
572971|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
572972|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
572973|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
572974|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
572975|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
572976|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
572977|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
573203|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
572978|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
572979|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
572980|NCT00924469|E2|Reported Event|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
573025|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
572981|NCT00924469|E1|Reported Event|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
572982|NCT00924482|B1|Baseline|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.
Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.
Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
572983|NCT00924482|P1|Participant Flow|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.
Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique.
Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
572984|NCT00924482|O1|Outcome|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery.
Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.
Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
572985|NCT00924482|O1|Outcome|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.
Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.
Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
572986|NCT00924482|E1|Reported Event|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.
Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.
Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
572987|NCT00924508|B1|Baseline|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
572988|NCT00924508|P1|Participant Flow|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
572989|NCT00924508|O1|Outcome|Hydrogel Patch Alone, TAC 0.1%, TAC + Patch|"This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, the second treated with 0.1 % triamcinolone ointment without patch, and the third treated with occlusion of eczema patch without ointment.
occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, occlusion alone, and ointment alone"
572990|NCT00924508|O3|Outcome|Patch + TAC|Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily and triamcinolone (TAC) 0.1% cream twice daily to one lesion. After 4 weeks of occlusion + TAC treatment, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
572991|NCT00924508|O2|Outcome|TAC 0.1%|Patients were instructed to apply TAC 0.1% twice daily to one lesion. After 4 weeks, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
572992|NCT00924508|O1|Outcome|Hydrogel Patch|Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily. After 4 weeks of occlusion therapy, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
573026|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
572993|NCT00924508|E1|Reported Event|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
572994|NCT00924560|B4|Baseline|Total|Total of all reporting groups
572995|NCT00924560|B3|Baseline|Untreated Control|Participants received no oral contraceptives during the study.
572996|NCT00924560|B2|Baseline|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
572997|NCT00924560|B1|Baseline|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
572998|NCT00924560|P3|Participant Flow|Untreated Control|Participants received no oral contraceptives during the study.
572999|NCT00924560|P2|Participant Flow|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573000|NCT00924560|P1|Participant Flow|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573001|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573002|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573003|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573004|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573005|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573006|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573007|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573008|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573009|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573010|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573011|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573012|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573013|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573014|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573015|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573016|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573017|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573018|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573019|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573204|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
573021|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573022|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573023|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573024|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573029|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573030|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573031|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573032|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573033|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573034|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573035|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573036|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573037|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
573038|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573039|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573040|NCT00924560|E3|Reported Event|Untreated Control|Participants received no oral contraceptives during the study.
573041|NCT00924560|E2|Reported Event|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
573042|NCT00924560|E1|Reported Event|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
573043|NCT00924638|B3|Baseline|Total|Total of all reporting groups
573044|NCT00924638|B2|Baseline|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
573045|NCT00924638|B1|Baseline|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
573046|NCT00924638|P2|Participant Flow|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
573047|NCT00924638|P1|Participant Flow|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
573048|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
573049|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
573050|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
573052|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
573053|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
573054|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
573055|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
573056|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
573057|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
573094|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
573058|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
573059|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
573060|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
573061|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
573062|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
573063|NCT00924638|E2|Reported Event|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
573064|NCT00924638|E1|Reported Event|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
573065|NCT00924651|B3|Baseline|Total|Total of all reporting groups
573066|NCT00924651|B2|Baseline|Standard Care|Wait list control
573067|NCT00924651|B1|Baseline|Standard Care + EXCAP|"Personalized exercise prescription
exercise: home based walking and progressive resistance training exercise"
573068|NCT00924651|P2|Participant Flow|Standard Care|Wait list control
573069|NCT00924651|P1|Participant Flow|Standard Care + EXCAP|"Personalized exercise prescription
exercise: home based walking and progressive resistance training exercise"
573070|NCT00924651|O2|Outcome|Standard Care|Wait list control
573071|NCT00924651|O1|Outcome|Standard Care + EXCAP|"Personalized exercise prescription
exercise: home based walking and progressive resistance training exercise"
573072|NCT00924651|E2|Reported Event|Standard Care|Wait list control
573073|NCT00924651|E1|Reported Event|Standard Care + EXCAP|"Personalized exercise prescription
exercise: home based walking and progressive resistance training exercise"
573074|NCT00924729|B3|Baseline|Total|Total of all reporting groups
573075|NCT00924729|B2|Baseline|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
573076|NCT00924729|B1|Baseline|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
573077|NCT00924729|P2|Participant Flow|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
573078|NCT00924729|P1|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
573079|NCT00924729|O2|Outcome|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
573080|NCT00924729|O1|Outcome|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
573081|NCT00924729|E2|Reported Event|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
573082|NCT00924729|E1|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
573083|NCT00924781|B5|Baseline|Total|Total of all reporting groups
573084|NCT00924781|B4|Baseline|MK2578 1mcg/350U QM|MK2578 IV administered QM.
573085|NCT00924781|B3|Baseline|MK2578 1mcg/350U QW|MK2578 IV administered QW.
573086|NCT00924781|B2|Baseline|MK2578 1mcg/600U QM|MK2578 IV administered QM.
573088|NCT00924781|P2|Participant Flow|MK2578 1mcg/600 U or 1 mg/350 U QM|MK2578 was administered IV QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) or 350 units of Epogen (epoetin alpha) received per week at Baseline.
573089|NCT00924781|P1|Participant Flow|MK2578 1mcg/600 U or 1 mcg/350 U QW|MK2578 was administered intravenously (IV) QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
573090|NCT00924781|O4|Outcome|MK-2578 1mcg/350U QM|MK2578 IV was administered QM. Participatns were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alpha) received per 4 weeks at Baseline.
573091|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
573092|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
573093|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK3578 IV was administered QW. Participants were randomized to receive 1 mcg of MK-2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573131|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
573095|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
573096|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573097|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573098|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
573099|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every U of Epogen (epoetin alpha) received per week at Baseline.
573100|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573101|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573102|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM.Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
573103|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
573104|NCT00924781|O2|Outcome|MK2578 1mcg/600 QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573105|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573106|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
573107|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
573108|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573109|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573110|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
573111|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
573112|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573113|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573114|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
573115|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
573116|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
573117|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
573118|NCT00924781|E2|Reported Event|MK2578 QM|MK2578 IV administered once every 4 weeks.
573119|NCT00924781|E1|Reported Event|MK2578 QW|MK2578 IV administered once weekly.
573120|NCT00924807|B1|Baseline|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.
Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
573206|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
573121|NCT00924807|P1|Participant Flow|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.
Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
573122|NCT00924807|O1|Outcome|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.
Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
573123|NCT00924807|E1|Reported Event|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.
Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
573124|NCT00924833|B4|Baseline|Total|Total of all reporting groups
573125|NCT00924833|B3|Baseline|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
573126|NCT00924833|B2|Baseline|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
573127|NCT00924833|B1|Baseline|Placebo|Placebo tablets. One tablet twice daily.
573128|NCT00924833|P3|Participant Flow|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
573129|NCT00924833|P2|Participant Flow|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
573130|NCT00924833|P1|Participant Flow|Placebo|Placebo tablets. One tablet twice daily.
573134|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
573135|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
573136|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
573137|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
573138|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
573139|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
573140|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
573141|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
573142|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
573143|NCT00924898|B1|Baseline|Acute HIV Infection Treatment Group|This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
573144|NCT00924898|P1|Participant Flow|Acute HIV Infection Treatment Group|This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
573145|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants who remained on treatment at designated time points.
573146|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Baseline resistance testing was performed on all participants at enrollment.
573147|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Acute HIV infection treatment group
573148|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants who remained on study with viral suppression at week 96
573149|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants suppressed to <50 copies/mL prior at week 48
573150|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants suppressed to <200 copies/mL prior to or at week 24
573151|NCT00924898|E1|Reported Event|Acute HIV Infection Treatment Group|Single-arml study of once daily emtricitabine/tenofovir/efavirenz administered to participants with acute HIV infection
573152|NCT00924950|B1|Baseline|Ointment + Patch vs. Ointment Alone|
573153|NCT00924950|P1|Participant Flow|Ointment + Patch vs. Ointment Alone|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used topically to treat one psoriatic plaque with Hydrogel patch used over for occlusion for 6-8 hours daily. Within the same patient another patch of similar severity was chosen and was treated with Taclonex ointment alone without hydrogel patch occlusion
573154|NCT00924950|O2|Outcome|Taclonex Alone|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily without hydrogel patch.
573155|NCT00924950|O1|Outcome|Taclonex Ointment Occluded With Hydrogel Patch|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily topically to treat one psoriatic plaque, occluded with hydrogel patch for 6-8 hours each day.
573156|NCT00924950|E1|Reported Event|Ointment + Patch vs. Ointment Alone|
573157|NCT00925015|B4|Baseline|Total|Total of all reporting groups
573158|NCT00925015|B3|Baseline|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. Each cycle was 6 weeks long. For Drug-Drug Interaction (DDI).
573159|NCT00925015|B2|Baseline|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
573160|NCT00925015|B1|Baseline|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long.
573161|NCT00925015|P3|Participant Flow|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. Each cycle was 6 weeks long. For Drug-Drug Interaction (DDI).
573162|NCT00925015|P2|Participant Flow|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
573205|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
573234|NCT00925288|O1|Outcome|Regular Schedule|Participants in 0,2,6 month study arm
573163|NCT00925015|P1|Participant Flow|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long.
573164|NCT00925015|O3|Outcome|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. For DDI.
573165|NCT00925015|O2|Outcome|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
573166|NCT00925015|O1|Outcome|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1,8, 15, 22, 29 and 36.
573167|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573168|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573169|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573170|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573171|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573172|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573173|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573174|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573175|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573176|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573177|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573178|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573179|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573180|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573181|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573182|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573183|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573184|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573185|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573186|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573187|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573188|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573189|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573190|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573191|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
573192|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
573193|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
573194|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
573195|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
573196|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
573197|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
573198|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
573199|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
573200|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
573201|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
573202|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
573235|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
573207|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
573208|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
573209|NCT00925015|O3|Outcome|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. For DDI.
573210|NCT00925015|O2|Outcome|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
573211|NCT00925015|O1|Outcome|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1,8, 15, 22, 29 and 36.
573212|NCT00925015|O3|Outcome|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. For DDI.
573213|NCT00925015|O2|Outcome|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
573331|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573332|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573214|NCT00925015|O1|Outcome|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1,8, 15, 22, 29 and 36.
573215|NCT00925015|E3|Reported Event|Dalotuzumab 10 mg/Kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. Each cycle was 6 weeks long.
573216|NCT00925015|E2|Reported Event|Cetux/Irin - Dalotuzumab 15/7.5 mg/Kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Days 8, 22 and 36; followed in subsequent cycles by treatment with 7.5 mg/kg on Days 8, 22 and 36. Each cycle was 6 weeks long.
573217|NCT00925015|E1|Reported Event|Cetux/Irin - Dalotuzumab 10 mg/Kg|After treatment with Cetux and Irin, Dmab was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long.
573218|NCT00925132|B1|Baseline|Temozolomide, Decitabine, Panobinostat|"Temozolomide - given each cycle.
Decitabine - 6 cohorts with dose escalation.
Panobinostat - 6 cohorts with dose escalation.
Temozolomide, Decitabine, Panobinostat: Temozolomide - given each cycle.
Decitabine - 6 cohorts with dose escalation.
Panobinostat - 6 cohorts with dose escalation."
573219|NCT00925132|P5|Participant Flow|Phase II:Decitabine 0.2 mg/kg+Panobinostat 30mg+Temozolomide|Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly and Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
573220|NCT00925132|P4|Participant Flow|Phase I:Decitabine 0.2 mg/kg + Panobinostat 30mg +Temozolomide|Cohort 4: Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly and Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
573221|NCT00925132|P3|Participant Flow|Phase I:Decitabine 0.2 mg/kg + Panobinostat 20mg+Temozolomide|Cohort 3: Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 20mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
573222|NCT00925132|P2|Participant Flow|Phase I:Decitabine 0.1 mg/kg + Panobinostat 20mg +Temozolomide|Cohort 2: Participants were administered Decitabine 0.1 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 20mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
573223|NCT00925132|P1|Participant Flow|Phase I:Decitabine 0.1mg/kg + Panobinostat 10mg + Temozolomide|Cohort 1: Participants were administered Decitabine 0.1 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 10mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
573224|NCT00925132|O1|Outcome|Phase II:Decitabine 0.2 mg/kg +Panobinostat 30mg+Temozolomide|Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly and Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
573225|NCT00925132|O1|Outcome|Phase II:Decitabine 0.2 mg/kg +Panobinostat 30mg +Temozolomide|Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
573226|NCT00925132|O1|Outcome|Phase I Dose Escalation|"Temozolomide - given each cycle.
Decitabine - 6 cohorts with dose escalation.
Panobinostat - 6 cohorts with dose escalation."
573227|NCT00925132|E1|Reported Event|Temozolomide, Decitabine, Panobinostat|"Temozolomide - given each cycle.
Decitabine - 6 cohorts with dose escalation.
Panobinostat - 6 cohorts with dose escalation.
Temozolomide, Decitabine, Panobinostat: Temozolomide - given each cycle.
Decitabine - 6 cohorts with dose escalation.
Panobinostat - 6 cohorts with dose escalation."
573228|NCT00925288|B3|Baseline|Total|Total of all reporting groups
573229|NCT00925288|B2|Baseline|Modified Schedule|Duration: 0,3,6 months
573230|NCT00925288|B1|Baseline|Regular Schedule|Duration: 0,2,6 months
573231|NCT00925288|P2|Participant Flow|Modified Schedule|Duration: 0,3,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
573232|NCT00925288|P1|Participant Flow|Regular Schedule|Duration: 0,2,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
573233|NCT00925288|O2|Outcome|Modified Schedule|Participants in 0,3,6 month study arm
573239|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
573240|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
573241|NCT00925288|E2|Reported Event|Modified Schedule|Duration: 0,3,6 months
573242|NCT00925288|E1|Reported Event|Regular Schedule|Duration: 0,2,6 months
573243|NCT00925353|B1|Baseline|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
573244|NCT00925353|P1|Participant Flow|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
573245|NCT00925353|O1|Outcome|Lidocaine Gel Group|Plasma concentration of lidocaine and MEGX after one-time application of 1 oz. of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography.
573246|NCT00925353|E1|Reported Event|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
573333|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573334|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573335|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573336|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573247|NCT00925522|B1|Baseline|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists three system components:
A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.
The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.
The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids."
573248|NCT00925522|P1|Participant Flow|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists of following three system components:
A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.
The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.
The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient’s vascular system through the cat"
573249|NCT00925522|O1|Outcome|Therapy Cool Path Duo Catheter|All patients received RF (radio frequency) therapy from ablation catheter.
573250|NCT00925522|E1|Reported Event|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists of:
A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.
The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.
The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient’s vascular system through the catheter in the hospital environment."
573251|NCT00925548|B3|Baseline|Total|Total of all reporting groups
573252|NCT00925548|B2|Baseline|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573253|NCT00925548|B1|Baseline|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573254|NCT00925548|P2|Participant Flow|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 grams per liter (g/L) infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573255|NCT00925548|P1|Participant Flow|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573320|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573256|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573337|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573338|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573339|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573340|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573341|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573257|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573258|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573259|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573260|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573261|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573262|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573263|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573264|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573265|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573321|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573322|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573266|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573267|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573268|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573269|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573270|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573271|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573272|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573273|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573274|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573275|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573323|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573324|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573276|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573277|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573278|NCT00925548|E2|Reported Event|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
573279|NCT00925548|E1|Reported Event|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
573280|NCT00925587|B3|Baseline|Total|Total of all reporting groups
573281|NCT00925587|B2|Baseline|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573282|NCT00925587|B1|Baseline|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573283|NCT00925587|P2|Participant Flow|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573284|NCT00925587|P1|Participant Flow|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573285|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573286|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573287|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573288|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573289|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573290|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573291|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573292|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573293|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573294|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573295|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573296|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573297|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573298|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573299|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573300|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573301|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573302|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573303|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573304|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573305|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573306|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573307|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573308|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573309|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573310|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573311|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573312|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573313|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573314|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573315|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573316|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573317|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573318|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573319|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573325|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573326|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573327|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573328|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573329|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573330|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573342|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573343|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573344|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573345|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573346|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573347|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573348|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573349|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573350|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573351|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573352|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573353|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573354|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573355|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573356|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573357|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573358|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573359|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573360|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573361|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573362|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573363|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573364|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573365|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573366|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573367|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573368|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573369|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573370|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573371|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573372|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573373|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573374|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573375|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573376|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573377|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573378|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573379|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573380|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573381|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573382|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573383|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573384|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573385|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573386|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573387|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573388|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573389|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
575619|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
573390|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573391|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573392|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573393|NCT00925587|E2|Reported Event|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
573394|NCT00925587|E1|Reported Event|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
573395|NCT00925600|B3|Baseline|Total|Total of all reporting groups
573396|NCT00925600|B2|Baseline|Denosumab|Participants randomized to receive denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
573397|NCT00925600|B1|Baseline|Placebo|Participants randomized to receive placebo administered by subcutaneous injection on Day 1 and at Month 6.
573398|NCT00925600|P2|Participant Flow|Denosumab|Participants randomized to receive denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
573399|NCT00925600|P1|Participant Flow|Placebo|Participants randomized to receive placebo administered by subcutaneous injection on Day 1 and at Month 6.
573400|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
573401|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
573402|NCT00925600|O4|Outcome|Denosumab - Right Eye|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
573689|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573403|NCT00925600|O3|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
573404|NCT00925600|O2|Outcome|Placebo - Right Eye|Participants received placebo subcutaneous injection on Day 1 and at Month 6.
573405|NCT00925600|O1|Outcome|Placebo - Left Eye|Participants received placebo subcutaneous injection on Day 1 and at Month 6.
573406|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
573407|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
573408|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
573409|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
573410|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
573411|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
573412|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
573413|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
573414|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
573415|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
573416|NCT00925600|E2|Reported Event|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
573417|NCT00925600|E1|Reported Event|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
573418|NCT00915876|B3|Baseline|Total|Total of all reporting groups
573419|NCT00915876|B2|Baseline|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
573420|NCT00915876|B1|Baseline|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
573421|NCT00915876|P2|Participant Flow|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
573422|NCT00915876|P1|Participant Flow|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
573423|NCT00915876|O2|Outcome|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
573424|NCT00915876|O1|Outcome|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
573425|NCT00915876|E2|Reported Event|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
573426|NCT00915876|E1|Reported Event|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
573427|NCT00915902|B3|Baseline|Total|Total of all reporting groups
573428|NCT00915902|B2|Baseline|Placebo Followed by Treatment (Lovaza)|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by treatment (Lovaza) for 8 weeks
573429|NCT00915902|B1|Baseline|Treatment (Lovaza) Followed by Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks
573430|NCT00915902|P2|Participant Flow|Placebo Then Lovaza|Placebo for 8 weeks, then 4 week washout, then Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks
573431|NCT00915902|P1|Participant Flow|Lovaza Then Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks, then 4 week washout, then Placebo for 8 weeks
573432|NCT00915902|O2|Outcome|Placebo|Placebo: Placebo, two 1-gram capsules taken twice daily for 8 weeks
573433|NCT00915902|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Omega-3-acid ethyl esters: Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily
573434|NCT00915902|E4|Reported Event|Placebo Followed by Treatment (Lovaza), During Treatment|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week Treatment with Lovaza that followed 8 weeks of placebo and a 4 week washout.
573435|NCT00915902|E3|Reported Event|Placebo Followed by Treatment (Lovaza), During Placebo|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week placebo, after 8 weeks of treatment with Lovaza and a 4 week washout.
573436|NCT00915902|E2|Reported Event|Treatment (Lovaza) Followed by Placebo, During Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of placebo, after 8 weeks of treatment and 4 weeks of washout.
573471|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573437|NCT00915902|E1|Reported Event|Treatment (Lovaza) Followed by Placebo, During Treatment|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of treatment before placebo.
573438|NCT00916006|B3|Baseline|Total|Total of all reporting groups
573439|NCT00916006|B2|Baseline|Vehicle|Vehicle gel once daily for 3 consecutive days
573440|NCT00916006|B1|Baseline|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
573441|NCT00916006|P2|Participant Flow|Vehicle|Vehicle gel once daily for 3 consecutive days
573442|NCT00916006|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
573443|NCT00916006|O2|Outcome|Vehicle Gel|Vehicle Gel once daily for 3 consecutive days
573444|NCT00916006|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
573445|NCT00916006|O2|Outcome|Vehicle Gel|Vehicle Gel once daily for 3 consecutive days
573446|NCT00916006|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
573447|NCT00916006|E2|Reported Event|Vehicle|Vehicle gel once daily for 3 consecutive days
573448|NCT00916006|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
573622|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573449|NCT00916032|B1|Baseline|All Study Participants|Participants were randomized to receive via intravenous infusion 3000 International Units (IU) Advate using either one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence.
573450|NCT00916032|P2|Participant Flow|One 3000 IU Vial Then Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573451|NCT00916032|P1|Participant Flow|Two 1500 IU Vials Then One 3000 IU Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) followed by one 3000 IU potency vial dissolved in 5 mL diluent.
573452|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573453|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573454|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573455|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573456|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573457|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573458|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573459|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573460|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573461|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573462|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573463|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573464|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573465|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573466|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573467|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573468|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573469|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573470|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573609|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
575620|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
573472|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573473|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573474|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573475|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573476|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573477|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573623|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573478|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573479|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573480|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573481|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573482|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573483|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573484|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573485|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573486|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
573487|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
573488|NCT00916032|E2|Reported Event|Two 1500 IU Vials|
573489|NCT00916032|E1|Reported Event|One 3000 International Unit (IU) Vial|
573490|NCT00916136|B3|Baseline|Total|Total of all reporting groups
573491|NCT00916136|B2|Baseline|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
573492|NCT00916136|B1|Baseline|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
573493|NCT00916136|P2|Participant Flow|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
573494|NCT00916136|P1|Participant Flow|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
573495|NCT00916136|O2|Outcome|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
573496|NCT00916136|O1|Outcome|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
573497|NCT00916136|O2|Outcome|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
573498|NCT00916136|O1|Outcome|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
573499|NCT00916136|E2|Reported Event|Skeletal Traction|"A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation."
573556|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573500|NCT00916136|E1|Reported Event|Cutaneous Traction|"Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation."
573501|NCT00916279|B1|Baseline|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
573502|NCT00916279|P1|Participant Flow|Lutonix DCB Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
573503|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
573504|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix paclitaxel-coated PTCA balloon catheter
573505|NCT00916279|O1|Outcome|Lutonix PTCA Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
573506|NCT00916279|O1|Outcome|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
573507|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix paclitaxel-coated PTCA balloon catheter
573508|NCT00916279|E1|Reported Event|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
573509|NCT00916305|B3|Baseline|Total|Total of all reporting groups
573510|NCT00916305|B2|Baseline|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.
Unmodified audio video: An audio video with unaltered music"
573511|NCT00916305|B1|Baseline|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club
Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
573512|NCT00916305|P2|Participant Flow|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.
Unmodified audio video: An audio video with unaltered music"
573513|NCT00916305|P1|Participant Flow|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club
Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
573514|NCT00916305|O2|Outcome|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.
Unmodified audio video: An audio video with unaltered music"
573515|NCT00916305|O1|Outcome|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club
Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
573516|NCT00916305|O2|Outcome|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.
Unmodified audio video: An audio video with unaltered music"
573517|NCT00916305|O1|Outcome|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club
Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
573518|NCT00916305|E2|Reported Event|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.
Unmodified audio video: An audio video with unaltered music"
573519|NCT00916305|E1|Reported Event|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club
Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
573520|NCT00916344|B1|Baseline|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
573521|NCT00916344|P1|Participant Flow|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
573522|NCT00916344|O1|Outcome|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
573523|NCT00916344|O1|Outcome|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
573524|NCT00916344|E1|Reported Event|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
573525|NCT00916357|B1|Baseline|Overall Study|Participants who received at least 1 dose of Humalog, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 during dose-finding (DV) visits or experimental (data gathering) visits.
573526|NCT00916357|P6|Participant Flow|Humulin-R + rHuPH20, Then Humalog + rHuPH20, Then Humalog|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog alone following a 3- to 14-day washout period.
573527|NCT00916357|P5|Participant Flow|Humulin-R + rHuPH20, Then Humalog, Then Humalog + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog alone. The DF process and injection of appropriate dose was then repeated with 0.3-to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
573528|NCT00916357|P4|Participant Flow|Humalog + rHuPH20, Then Humulin-R + rHuPH20, Then Humalog|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humulin-R + rHuPH20. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog following a 3- to 14-day washout period.
573607|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573608|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573529|NCT00916357|P3|Participant Flow|Humalog + rHuPH20, Then Humalog, Then Humulin-R + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog alone. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period
573530|NCT00916357|P2|Participant Flow|Humalog, Then Humulin-R + rHuPH20, Then Humalog + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 nanograms/kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20). The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
573531|NCT00916357|P1|Participant Flow|Humalog, Then Humalog + rHuPH20, Then Humulin-R + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout period), followed by a SC injection of the appropriate dose of Humalog. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with up to 0.3- to 0.5-U/kg Humalog + 3.75 nanograms/kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20). The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
573532|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573533|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573534|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
573535|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573536|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573537|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
573538|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573539|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573540|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
573541|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573542|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573543|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
573544|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573545|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573546|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
573547|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573548|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573549|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
573550|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573551|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573552|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
573553|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573554|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573555|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
577194|NCT00931801|O4|Outcome|Total|All study arms combined
573557|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573558|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
573559|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573560|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573561|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
573562|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573563|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
573564|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
573565|NCT00916357|E3|Reported Event|Humulin-R + rHuPH20|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20 during Periods 1, 2, or 3 of the Study
573566|NCT00916357|E2|Reported Event|Humalog + rHuPH20|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20 during Periods 1, 2, or 3 of the study.
573567|NCT00916357|E1|Reported Event|Humalog Alone|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout period), followed by a SC injection of the appropriate dose of Humalog during Periods 1, 2, or 3 of the study.
573568|NCT00916370|B3|Baseline|Total|Total of all reporting groups
573569|NCT00916370|B2|Baseline|Long Lesion Registry|Use of long lesion stents.
573570|NCT00916370|B1|Baseline|Core Size Registry|Core size indicates the range of diameters of the stents used.
573571|NCT00916370|P2|Participant Flow|Long Lesion Registry|Use of long lesion stents.
573572|NCT00916370|P1|Participant Flow|Core Size Registry|Core size indicates the range of diameters of the stents used.
573573|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573574|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573575|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573576|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573577|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573578|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573579|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573580|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573581|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573582|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573583|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573584|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573585|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573586|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573587|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573588|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573589|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573590|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573591|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573592|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573593|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573594|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573595|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573596|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573597|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573598|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573599|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573600|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573601|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573602|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573603|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573604|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573605|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573606|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573610|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573611|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573612|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573613|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573614|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573615|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573616|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573617|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573618|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573619|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573620|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573621|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573624|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573625|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573626|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573627|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573628|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573629|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573630|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573631|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573632|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573633|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573634|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573635|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573636|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573637|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573638|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573639|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573640|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573641|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573642|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573643|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573644|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573645|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573646|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573647|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573648|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573649|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573650|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573651|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573652|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573653|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573654|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573655|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573656|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573657|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573658|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573659|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573660|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573661|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573662|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573663|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573664|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573665|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573666|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573667|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573668|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573669|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573670|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573671|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573672|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573673|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573674|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573675|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573676|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573677|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573678|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573679|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573680|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573681|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573682|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573683|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573684|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573685|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573686|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573687|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573688|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573690|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573691|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573692|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573693|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573694|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573695|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573696|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573697|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573698|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573699|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573700|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573701|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573702|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573703|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573704|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573705|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573706|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573707|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573708|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573709|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573710|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573711|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573712|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573713|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573714|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573715|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573716|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573717|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573718|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573719|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573720|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573721|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573722|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573723|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573724|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573725|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573726|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573727|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
573728|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573729|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573730|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573731|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573732|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573733|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573734|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573735|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573736|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573737|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573738|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573739|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
577832|NCT00937105|O2|Outcome|Participants Without Corneal Staining|
573740|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573741|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
573742|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
573743|NCT00916370|E2|Reported Event|Long Lesion Registry|Use of long lesion stents.
573744|NCT00916370|E1|Reported Event|Core Size Registry|Core size indicates the range of diameters of the stents used.
573745|NCT00916383|B1|Baseline|All Participants|All patients received the same study treatment, consisting of 1 placebo patch and 1 Donepezil Transdermal Patch, and all patches were applied to the same body locations according to 1 of 6 treatment sequences. The active patch was applied to either the right or the left side of the body according to the randomization schedule. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 body locations (upper arm, upper back, side of torso) for a total treatment period of 21 days.
573799|NCT00916617|B2|Baseline|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
573800|NCT00916617|B1|Baseline|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
573746|NCT00916383|P1|Participant Flow|All Participants|"Patients were randomized to receive the active patch on the left or right side of the body, and the matching placebo patch on the same location on the opposite side of the body, and assigned to one of two sets (left and right of the body for placement of the active patch) of the following 6 treatment sequences. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 consecutive body locations, for a total exposure period of 21 days.
Upper Back, Upper Arm, Side of Torso
Upper Arm, Side of Torso, Upper Back
Side of Torso, Upper Back, Upper Arm
Upper Back, Side of Torso, Upper Arm
Upper Arm, Upper Back, Side of Torso
Side of Torso, Upper Arm, Upper Back
Skin irritation scoring was obtained immediately upon removal of the patch and at 1, 24, and 48 hours after removal."
573747|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
573748|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
573749|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
573750|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
573751|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
573752|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
573753|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
573754|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
573755|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
573756|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
573757|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
573758|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
573759|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
573760|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
573761|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
573762|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
573763|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
573764|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
573765|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
573766|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
573767|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
573768|NCT00916383|E3|Reported Event|Placebo Patch|Localized events
573769|NCT00916383|E2|Reported Event|DTP-system|Localized events
573770|NCT00916383|E1|Reported Event|Systemic Events|All enrolled patients
573771|NCT00916539|B3|Baseline|Total|Total of all reporting groups
573772|NCT00916539|B2|Baseline|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573773|NCT00916539|B1|Baseline|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573774|NCT00916539|P2|Participant Flow|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573775|NCT00916539|P1|Participant Flow|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573776|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573777|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573778|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573779|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573780|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573781|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573782|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573783|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573784|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573785|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573786|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573787|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573788|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573789|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573790|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573791|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573792|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573793|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573794|NCT00916539|E2|Reported Event|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
573795|NCT00916539|E1|Reported Event|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
573796|NCT00916617|B5|Baseline|Total|Total of all reporting groups
573797|NCT00916617|B4|Baseline|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
573798|NCT00916617|B3|Baseline|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
575076|NCT00927927|B11|Baseline|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
573801|NCT00916617|P4|Participant Flow|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
573802|NCT00916617|P3|Participant Flow|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
573803|NCT00916617|P2|Participant Flow|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
573804|NCT00916617|P1|Participant Flow|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
573805|NCT00916617|O4|Outcome|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
573806|NCT00916617|O3|Outcome|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
573807|NCT00916617|O2|Outcome|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
573808|NCT00916617|O1|Outcome|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
573809|NCT00916617|O4|Outcome|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
573810|NCT00916617|O3|Outcome|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
573811|NCT00916617|O2|Outcome|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
573812|NCT00916617|O1|Outcome|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
573813|NCT00916617|E4|Reported Event|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
573814|NCT00916617|E3|Reported Event|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
573815|NCT00916617|E2|Reported Event|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
573816|NCT00916617|E1|Reported Event|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
573817|NCT00916643|B1|Baseline|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:
Flushing the system with normal saline.
Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
Mixing the plasma with an equal volume of acetate buffer containing heparin.
Precipitation of LDL as a complex with heparin.
Removing the LDL-heparin precipitate by continuous circulation through a filter.
Removing heparin with use of a heparin adsorber.
Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
573818|NCT00916643|P1|Participant Flow|H.E.L.P. Secura|"All patients received the same Treatment Arm for this study. Treatments were conducted up to 3 times per week; treatment sessions typ. 2 hours in length.
H.E.L.P. is a device composed of multiple modules and associated disposables to selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient.
Flush system with normal saline;
Filter whole blood through 0.2 micron plasma filter for continuous plasma removal;
Mix plasma with equal volume of acetate buffer containing heparin;
Precipitate LDL as a complex with heparin;
Remove LDL-heparin precipitate by continuous circulation through a filter;
Remove heparin with use of a heparin adsorber;
Bicarbonate dialysis and ultrafiltration to produce LDL-free plasma without excess heparin;
Re-mix LDL-free plasma with blood from plasma filter; return reconstituted blood to patient."
573846|NCT00916929|O2|Outcome|Implantable Cardioverter Defibrillator (ICD) Device|Algorithm in cardiac device that measures intra-thoracic impedance from implanted leads
573847|NCT00916929|O1|Outcome|Cardiac Resynchronization Therapy (CRT-D) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
573848|NCT00916929|E2|Reported Event|ICD Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
573849|NCT00916929|E1|Reported Event|CRT-D Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil
573819|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:
Flushing the system with normal saline.
Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
Mixing the plasma with an equal volume of acetate buffer containing heparin.
Precipitation of LDL as a complex with heparin.
Removing the LDL-heparin precipitate by continuous circulation through a filter.
Removing heparin with use of a heparin adsorber.
Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
573853|NCT00917124|P2|Participant Flow|INVOS|INVOS (In Vivo optical Spectroscopy): Monitoring cerebral oxygenation (rSO2) with INVOS device. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
573820|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:
Flushing the system with normal saline.
Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
Mixing the plasma with an equal volume of acetate buffer containing heparin.
Precipitation of LDL as a complex with heparin.
Removing the LDL-heparin precipitate by continuous circulation through a filter.
Removing heparin with use of a heparin adsorber.
Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
573821|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:
Flushing the system with normal saline.
Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
Mixing the plasma with an equal volume of acetate buffer containing heparin.
Precipitation of LDL as a complex with heparin.
Removing the LDL-heparin precipitate by continuous circulation through a filter.
Removing heparin with use of a heparin adsorber.
Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
573822|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:
Flushing the system with normal saline.
Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
Mixing the plasma with an equal volume of acetate buffer containing heparin.
Precipitation of LDL as a complex with heparin.
Removing the LDL-heparin precipitate by continuous circulation through a filter.
Removing heparin with use of a heparin adsorber.
Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
573823|NCT00916643|E1|Reported Event|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:
Flushing the system with normal saline.
Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
Mixing the plasma with an equal volume of acetate buffer containing heparin.
Precipitation of LDL as a complex with heparin.
Removing the LDL-heparin precipitate by continuous circulation through a filter.
Removing heparin with use of a heparin adsorber.
Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
573824|NCT00916721|B3|Baseline|Total|Total of all reporting groups
573825|NCT00916721|B2|Baseline|Placebo|
573826|NCT00916721|B1|Baseline|Propranolol|
573827|NCT00916721|P2|Participant Flow|Placebo|A single oral dose of identical placebo capsule in a double-blind fashion
573828|NCT00916721|P1|Participant Flow|Propranolol|A single oral dose of propranolol or identical placebo capsule in a double-blind fashion. Propranolol dose was 0.67 mg/kg of the short-acting formulation, rounded to the nearest 10 mg, with a minimum dose of 40 mg and a maximum dose of 80 mg
573829|NCT00916721|O2|Outcome|Placebo|
573830|NCT00916721|O1|Outcome|Propranolol|
573831|NCT00916721|O2|Outcome|Placebo|
573832|NCT00916721|O1|Outcome|Propranolol|
573833|NCT00916721|O2|Outcome|Placebo|
573834|NCT00916721|O1|Outcome|Propranolol|
573835|NCT00916721|O2|Outcome|Placebo|
573836|NCT00916721|O1|Outcome|Propranolol|
573837|NCT00916721|E2|Reported Event|Placebo|
573838|NCT00916721|E1|Reported Event|Propranolol|
573839|NCT00916929|B3|Baseline|Total|Total of all reporting groups
573840|NCT00916929|B2|Baseline|CRT-D Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
573841|NCT00916929|B1|Baseline|ICD Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
573842|NCT00916929|P2|Participant Flow|Cardiac Resynchronization Therapy (CRT-D) Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy device algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
573843|NCT00916929|P1|Participant Flow|Implantable Cardioverter Defibrillator (ICD) Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
573844|NCT00916929|O2|Outcome|Implantable Cardioverter Defibrillator (ICD) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
573845|NCT00916929|O1|Outcome|Cardiac Resynchronizaiton Therapy (CRT-D) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
573850|NCT00917124|B3|Baseline|Total|Total of all reporting groups
573851|NCT00917124|B2|Baseline|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
573852|NCT00917124|B1|Baseline|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
573854|NCT00917124|P1|Participant Flow|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
573855|NCT00917124|O2|Outcome|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
573856|NCT00917124|O1|Outcome|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
573857|NCT00917124|O2|Outcome|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
573858|NCT00917124|O1|Outcome|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
573859|NCT00917124|E2|Reported Event|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
573860|NCT00917124|E1|Reported Event|INVOS|INVOS : Monitoring cerebral oxygenation (rSO2) with INVOS. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
573861|NCT00917267|B3|Baseline|Total|Total of all reporting groups
573862|NCT00917267|B2|Baseline|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573863|NCT00917267|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573864|NCT00917267|P2|Participant Flow|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573865|NCT00917267|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573866|NCT00917267|O4|Outcome|Exenatide Twice Daily Without SU Use at Screening|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and without SU use at Screening
573867|NCT00917267|O3|Outcome|Exenatide Once Weekly Without SU Use at Screening|Subcutaneous injection of 2 mg exenatide, once a week and without SU use at Screening
573868|NCT00917267|O2|Outcome|Exenatide Twice Daily With SU Use at Screening|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and with SU use at Screening
573869|NCT00917267|O1|Outcome|Exenatide Once Weekly With SU Use at Screening|Subcutaneous injection of 2 mg exenatide, once a week and with SU use at Screening
573870|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573871|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573872|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573873|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573874|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573875|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573876|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573877|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573878|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573879|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573880|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573881|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573882|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573883|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573884|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573885|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573886|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573887|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573888|NCT00917267|E2|Reported Event|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
573889|NCT00917267|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
573890|NCT00917384|B3|Baseline|Total|Total of all reporting groups
573935|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
573891|NCT00917384|B2|Baseline|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573892|NCT00917384|B1|Baseline|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573893|NCT00917384|P2|Participant Flow|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus BSC as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573894|NCT00917384|P1|Participant Flow|IMC-1121B (Ramucirumab )|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined appropriate by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573895|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573896|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573897|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573898|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573899|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573900|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573901|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573902|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573927|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
573903|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573904|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573905|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573906|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573907|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573908|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573909|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573910|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573911|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573912|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573913|NCT00917384|E2|Reported Event|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573914|NCT00917384|E1|Reported Event|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
573915|NCT00917501|B3|Baseline|Total|Total of all reporting groups
573916|NCT00917501|B2|Baseline|Omega-3|Fish oil - 3 capsules/day
573917|NCT00917501|B1|Baseline|Placebo|Olive oil - 3 capsules/day
573918|NCT00917501|P2|Participant Flow|Omega-3|Fish oil - 3 capsules/day
573919|NCT00917501|P1|Participant Flow|Placebo|Olive oil - 3 capsules/day
573920|NCT00917501|O2|Outcome|Omega-3|Fish oil - 3 capsules/day
573921|NCT00917501|O1|Outcome|Placebo|Olive oil - 3 capsules/day
573922|NCT00917501|E2|Reported Event|Omega-3|Fish oil - 3 capsules/day
573923|NCT00917501|E1|Reported Event|Placebo|Olive oil - 3 capsules/day
573924|NCT00917579|B1|Baseline|Total Number of Participants|All participants received atorvastatin 10 mg tablets (new and marketed).
573925|NCT00917579|P2|Participant Flow|Reference Drug First, Then Test Drug|Marketed (reference) 10 mg atorvastatin commercial tablet (Lipitor®) as a single oral dose in the first intervention period, and new (test) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
573926|NCT00917579|P1|Participant Flow|Test Drug First, Then Reference Drug|New (test) 10 milligram (mg) atorvastatin tablet as a single oral dose in the first intervention period, and marketed (reference) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
575072|NCT00927927|B15|Baseline|MD Placebo|Subjects were injected biweekly four times with placebo
573928|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
573929|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
573930|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
573931|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
573932|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
573933|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
573934|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
573973|NCT00917865|P1|Participant Flow|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
573936|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
573937|NCT00917579|E2|Reported Event|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single dose.
573938|NCT00917579|E1|Reported Event|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose.
573939|NCT00917644|B1|Baseline|Total Study Population|New 80 milligram (mg) atorvastatin tablets (test); marketed 80 mg atorvastatin commercial tablet (Lipitor®) (reference)
573940|NCT00917644|P2|Participant Flow|Reference Drug First|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period and new (test) 80 mg atorvastatin tablets as a single dose in the second intervention period (after washout period).
573941|NCT00917644|P1|Participant Flow|Test Drug First|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period and marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the second intervention period (after washout period).
573942|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
573943|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
573944|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
573945|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
573946|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
573947|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
573948|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
573949|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
573950|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
573951|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
573952|NCT00917644|E2|Reported Event|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
573953|NCT00917644|E1|Reported Event|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
573954|NCT00917735|B3|Baseline|Total|Total of all reporting groups
573955|NCT00917735|B2|Baseline|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year
573956|NCT00917735|B1|Baseline|Green Tea Extract|Green tea extract supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year
573957|NCT00917735|P2|Participant Flow|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
573958|NCT00917735|P1|Participant Flow|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of epigallocatechin gallate (EGCG).
573959|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
573960|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
573961|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
573962|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
573963|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
573964|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
573965|NCT00917735|E2|Reported Event|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
573966|NCT00917735|E1|Reported Event|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
573967|NCT00917852|B1|Baseline|GORE Conformable TAG® Device Surgical Implant|
573968|NCT00917852|P1|Participant Flow|GORE Conformable TAG® Device Surgical Implant|
573969|NCT00917852|O1|Outcome|GORE Conformable TAG® Thoracic Endoprosthesis|Gore Conformable TAG Thoracic Endoprosthesis: Endovascular stent graft
573970|NCT00917852|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|
573971|NCT00917852|E1|Reported Event|CTAG Device Trauma Subjects|
573972|NCT00917865|B1|Baseline|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
573974|NCT00917865|O4|Outcome|Mean SUV Maxat 40minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 40 minutes
573975|NCT00917865|O3|Outcome|Mean SUV Max at 28 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 28 minutes
573976|NCT00917865|O2|Outcome|Mean SUV Maxat 16 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 16 minutes
573977|NCT00917865|O1|Outcome|Mean SUV Max at 4 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 4 minutes
573978|NCT00917865|O4|Outcome|Diagnostic Performance Per Sextant 40minutes Post Injection|"At this time point, the 120 sextants analysed were categorized as followed:
63 sextants were seen as true positive, 15 true negative, 25 false positive and 17 false negative"
573979|NCT00917865|O3|Outcome|Diagnostic Performance Per Sextant 28mins Post Injection|"At this time point, the 120 sextants analysed were categorized as followed:
65 sextants were seen as true positive, 20 true negative, 20 false positive and 15 false negative"
573980|NCT00917865|O2|Outcome|Diagnostic Performance Per sextant16mins Post Injetion|"At this time point, the 120 sextants analysed were categorized as followed:
68 sextants were seen as true positive, 14 true negative, 25 false positive and 13 false negative"
573981|NCT00917865|O1|Outcome|Diagnostic Performance Per Sextant at 4mins Post Injection|Each of the 120 sextants was visually analyzed for the presence or absence of tumor. 71 true positive, 7 True negative, 32 false positive and 8 false negative. Because of a technical error, 2 of the 120 sextants were not analysed at this time point.
573982|NCT00917865|E1|Reported Event|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
573983|NCT00918125|B3|Baseline|Total|Total of all reporting groups
573984|NCT00918125|B2|Baseline|White Patients|Patients who self-identified as White
573985|NCT00918125|B1|Baseline|Black Patients|Patients who self-identified as African American
573986|NCT00918125|P2|Participant Flow|Video Intervention|Patients in this arm viewed an educational video on sudden cardiac arrest and ICDs.
573987|NCT00918125|P1|Participant Flow|Standard of Care|Patients in this arm received standard of care (counseling from a physician).
573988|NCT00918125|O2|Outcome|Whites|All Whites in study
573989|NCT00918125|O1|Outcome|African Americans|All African Americans in study
573990|NCT00918125|O2|Outcome|Whites|Whites in study from all study arms
573991|NCT00918125|O1|Outcome|African Americans|African Americans in study from all study arms
573992|NCT00918125|O2|Outcome|Standard of Care|Usual care
573993|NCT00918125|O1|Outcome|Video|All patients who saw an educational video
573994|NCT00918125|O2|Outcome|Standard of Care|Usual care
573995|NCT00918125|O1|Outcome|Video|All patients who saw an educational video
573996|NCT00918125|E1|Reported Event|All Patients|Patients in this arm received standard of care (counseling from a physician).
573997|NCT00918138|B3|Baseline|Total|Total of all reporting groups
573998|NCT00918138|B2|Baseline|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
573999|NCT00918138|B1|Baseline|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
574000|NCT00918138|P2|Participant Flow|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
574001|NCT00918138|P1|Participant Flow|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
574002|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
574003|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
574004|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
574005|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
574006|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
574007|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
574008|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
574009|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
574010|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
574011|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
574012|NCT00918138|E2|Reported Event|Saxagliptin 5 mg + Metformin XR 1500 mg|Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo
574013|NCT00918138|E1|Reported Event|Metformin 2000 mg|Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo
574014|NCT00918203|B3|Baseline|Total|Total of all reporting groups
574015|NCT00918203|B2|Baseline|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574032|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
575628|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
574016|NCT00918203|B1|Baseline|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle
Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.
Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574017|NCT00918203|P3|Participant Flow|Crossover to Olaratumab Monotherapy|Olaratumab was administered IV at 15 mg/kg on Day 1 and Day 8 every 3 weeks.
574018|NCT00918203|P2|Participant Flow|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574019|NCT00918203|P1|Participant Flow|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel 200 milligram/square meter (mg/m2) over 3 hrs (Day 1) Carboplatin Area Under Concentration (AUC)=6 (Day 1) of each 21-day cycle
Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle
Participants who experience progressive disease may cross over to olaratumab monotherapy.
Paclitaxel: 200 mg/m2 is then administered intravenously (IV) over 3 hours
carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574020|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574021|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574022|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25 mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574023|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574024|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574025|NCT00918203|O2|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
574026|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574027|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574028|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574052|NCT00918255|P2|Participant Flow|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
574029|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574030|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
574031|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
575629|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
574033|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574034|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574035|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
574036|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574037|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574038|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
574039|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574040|NCT00918203|O1|Outcome|Olaratumab + Pacilitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574041|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
574042|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574043|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of Olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574044|NCT00918203|E3|Reported Event|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
574045|NCT00918203|E2|Reported Event|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574046|NCT00918203|E1|Reported Event|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle
Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.
Olaratumab: 15 mg/kg of IMC-3G3 on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.
Paclitaxel: 200 mg/m2 is then administered IV over 3 hours
Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
574047|NCT00918255|B4|Baseline|Total|Total of all reporting groups
574048|NCT00918255|B3|Baseline|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
574049|NCT00918255|B2|Baseline|Adalimumab 40 mg Eow DB|Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
574050|NCT00918255|B1|Baseline|Adalimumab 40 mg Qwk DB|Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
574051|NCT00918255|P3|Participant Flow|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
574053|NCT00918255|P1|Participant Flow|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
574054|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
574055|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
574056|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
574057|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
574058|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
574059|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
574060|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
574061|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
574062|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
574063|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
574064|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
574065|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
574066|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
574067|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
574068|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
574069|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
574070|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
574071|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
574072|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
574073|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
574074|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
574075|NCT00918255|E3|Reported Event|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
574076|NCT00918255|E2|Reported Event|Adalimumab 40 mg Eow DB|Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
574077|NCT00918255|E1|Reported Event|Adalimumab 40 mg Qwk DB|Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
574078|NCT00918281|B1|Baseline|1 Fluciclatide Injection|Fluciclatide Injection (AH111585 (18F) Injection)
574079|NCT00918281|P1|Participant Flow|1 Fluciclatide Injection|AH111585 (18F) Injection : AH111585 (18F) Injection
574080|NCT00918281|O1|Outcome|Number of Adverse Events|The number of adverse events in relationship to the categories descrbed using Fluciclatide Injection (AH111585 (18F) Injection).
574081|NCT00918281|O3|Outcome|Relative Difference|The Relative difference between imaging sessions 1 and 2.
574082|NCT00918281|O2|Outcome|Imaging Session 2|Fluciclatide Injection (AH111585 (18F) Injection)
574083|NCT00918281|O1|Outcome|Imaging Session 1|Fluciclatide Injection (AH111585 (18F) Injection) at 10mCi [370 megabecquerels (MBq)]
574084|NCT00918281|E1|Reported Event|1 Fluciclatide Injection|Fluciclatide Injection (AH111585 (18F) Injection)
574085|NCT00925704|B7|Baseline|Total|Total of all reporting groups
574086|NCT00925704|B6|Baseline|Sequence 6|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
574087|NCT00925704|B5|Baseline|Sequence 5|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
574088|NCT00925704|B4|Baseline|Sequence 4|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
574089|NCT00925704|B3|Baseline|Sequence 3|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
574090|NCT00925704|B2|Baseline|Sequence 2|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
574091|NCT00925704|B1|Baseline|Sequence 1|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
574092|NCT00925704|P6|Participant Flow|Sequence 6|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
574195|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
574093|NCT00925704|P5|Participant Flow|Sequence 5|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
574094|NCT00925704|P4|Participant Flow|Sequence 4|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
574095|NCT00925704|P3|Participant Flow|Sequence 3|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
574096|NCT00925704|P2|Participant Flow|Sequence 2|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
574097|NCT00925704|P1|Participant Flow|Sequence 1|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
574098|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the median of Tmax Sevelamer carbonate + Calcitriol minus the median of Tmax Calcitriol alone.
574099|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the median of Tmax Lanthanum carbonate + Calcitriol minus the median of Tmax Calcitriol alone.
574100|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the least squares mean of Cmax Sevelamer carbonate + Calcitriol minus least squares mean of Cmax Calcitriol alone.
574101|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the least squares mean of Cmax Lanthanum carbonate + Calcitriol minus least squares mean of Cmax Calcitriol alone.
574102|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the least squares mean of AUC 0-48 Sevelamer carbonate + Calcitriol minus least squares mean of AUC 0-48 Calcitriol alone.
574103|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the least squares mean of AUC 0-48 Lanthanum carbonate + Calcitriol minus least squares mean of AUC 0-48 Calcitriol alone.
574104|NCT00925704|E3|Reported Event|Calcitriol Alone|Calcitriol (1.0 microgram) single dose at lunch
574105|NCT00925704|E2|Reported Event|Sevelamer Carbonate + Calcitriol|Sevelamer carbonate (2400 mg three times daily with meals for one day) + Calcitriol (1 microgram single dose at lunch)
574106|NCT00925704|E1|Reported Event|Lanthanum Carbonate + Calcitriol|Lanthanum carbonate (1000 mg three times daily with meals for one day) + Calcitriol (1 microgram single dose at lunch)
574107|NCT00925769|B1|Baseline|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (Dose levels [DL]-1, 2, 3, 4, 5 and 6) were administered either oral 100 mg or 150 mg of erlotinib tablet daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574108|NCT00925769|P6|Participant Flow|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574109|NCT00925769|P5|Participant Flow|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574110|NCT00925769|P4|Participant Flow|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574263|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
577833|NCT00937105|O1|Outcome|Participants With Corneal Staining|
574111|NCT00925769|P3|Participant Flow|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574112|NCT00925769|P2|Participant Flow|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574196|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between
574113|NCT00925769|P1|Participant Flow|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 milligrams (mg) of erlotinib (ERL) tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 milligrams per kilogram (mg/kg) of bevacizumab (BEV) intravenous (IV) infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 milligrams per square meter (mg/m^2) of capecitabine (CAP) tablet twice daily (BID) within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574114|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574115|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574116|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574117|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574118|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574119|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574120|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574121|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574122|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574123|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574124|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574125|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574126|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574127|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574128|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574129|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574130|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574131|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574132|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574133|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574134|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574135|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574136|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574137|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574138|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574139|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574140|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574141|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
575608|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
574142|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574143|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574144|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574145|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574146|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574147|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574148|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574149|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574150|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574151|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574152|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574153|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574154|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574155|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574156|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574157|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
575609|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
574158|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574197|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
574159|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574160|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574161|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574162|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574163|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574164|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574165|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574166|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574167|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574168|NCT00925769|E6|Reported Event|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574169|NCT00925769|E5|Reported Event|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574170|NCT00925769|E4|Reported Event|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574171|NCT00925769|E3|Reported Event|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574264|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574172|NCT00925769|E2|Reported Event|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574273|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
575630|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
574173|NCT00925769|E1|Reported Event|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
574174|NCT00925782|B1|Baseline|All Study Participants|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients
574175|NCT00925782|P2|Participant Flow|Alkeran - Melphalan|"Randomized group of Alkeran-Melphalan
Alkeran for Injection (single-use glass vial containing melphalan HCl powder [equivalent to 50 mg melphalan] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.
Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder [equivalent to 50 mg of melphalan free base] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter."
574176|NCT00925782|P1|Participant Flow|Melphalan - Alkeran|"Randomized group of Melphalan - Alkeran sequence Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder [equivalent to 50 mg of melphalan free base] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.
Alkeran for Injection (single-use glass vial containing melphalan HCl powder [equivalent to 50 mg melphalan] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter."
574177|NCT00925782|O2|Outcome|Alkeran|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
574178|NCT00925782|O1|Outcome|Melphalan|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
574179|NCT00925782|O1|Outcome|Open-label, Randomized, Crossover Study|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation.
574180|NCT00925782|O1|Outcome|Open-label, Randomized, Cross-over Study|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients
574181|NCT00925782|O2|Outcome|Alkeran|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
574182|NCT00925782|O1|Outcome|Melphalan|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
574183|NCT00925782|E1|Reported Event|All Study Participants|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation. The time between randomized sequence of treatment is not sufficiently long to evaluate adverse events by intervention of or by sequence.
574184|NCT00925899|B3|Baseline|Total|Total of all reporting groups
574185|NCT00925899|B2|Baseline|Placebo. Then Melatonin|Placebo then melatonin: Placebo tablet orally every evening about one hour before bedtime for one week. Then one week melatonin 20 mg orally.
574186|NCT00925899|B1|Baseline|Melatonin, Then Placebo|Melatonin then placebo: 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Then 1 week placebo.
574187|NCT00925899|P2|Participant Flow|Part 1: Placebo, Then Melatonin|"First one week Placebo: Placebo tablet orally every evening about one hour before bedtime for one week.
Then one week Melatonin: 20 mg melatonin orally every evening about 1 hour before bedtime for one week."
574188|NCT00925899|P1|Participant Flow|Part 1: Melatonin, Then Placebo|"First one week Melatonin: 20 mg melatonin orally every evening about 1 hour before bedtime for one week.
Then one week Placebo: Placebo tablet orally every evening about one hour before bedtime for one week."
574189|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
574190|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
574191|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
574192|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
574193|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
574265|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574194|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
574274|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574198|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
574199|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
574200|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
574201|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
574202|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
574203|NCT00925899|E2|Reported Event|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg. for one week.
574204|NCT00925899|E1|Reported Event|Melatonin Then Placebo|Melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Then placebo for one week.
574205|NCT00925938|B4|Baseline|Total|Total of all reporting groups
574206|NCT00925938|B3|Baseline|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.
placebo : placebo"
574207|NCT00925938|B2|Baseline|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
574208|NCT00925938|B1|Baseline|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.
misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
574209|NCT00925938|P3|Participant Flow|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.
Part 1 and Part 2 participants were included in this arm of the study.
placebo : placebo"
574210|NCT00925938|P2|Participant Flow|MVPI 800 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.
Part 1 and Part 2 participants were included in this arm of the study.
Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB)."
574211|NCT00925938|P1|Participant Flow|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.
Part 1 participants were included in this arm of the study.
misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
574212|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.
placebo : placebo"
574213|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
574214|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.
misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
574215|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.
placebo : placebo"
574216|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
574217|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.
misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
574218|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.
placebo : placebo"
574266|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
575610|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
574219|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
574220|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.
misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
574221|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.
placebo : placebo"
574222|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
574223|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.
misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
574224|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.
placebo : placebo"
574225|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
574226|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.
misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
574227|NCT00925938|E3|Reported Event|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.
placebo : placebo"
574228|NCT00925938|E2|Reported Event|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
574229|NCT00925938|E1|Reported Event|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.
misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
574230|NCT00926185|B5|Baseline|Total|Total of all reporting groups
574231|NCT00926185|B4|Baseline|Placebo|
574232|NCT00926185|B3|Baseline|Lifitegrast 5.0%|
574233|NCT00926185|B2|Baseline|Lifitegrast 1.0%|
574234|NCT00926185|B1|Baseline|Lifitegrast 0.1%|
574235|NCT00926185|P4|Participant Flow|Placebo|
574236|NCT00926185|P3|Participant Flow|Lifitegrast 5.0%|
574237|NCT00926185|P2|Participant Flow|Lifitegrast 1.0%|
574238|NCT00926185|P1|Participant Flow|Lifitegrast 0.1%|
574239|NCT00926185|O4|Outcome|Placebo|
574240|NCT00926185|O3|Outcome|Lifitegrast 5.0%|
574241|NCT00926185|O2|Outcome|Lifitegrast 1.0%|
574242|NCT00926185|O1|Outcome|Lifitegrast 0.1%|
574243|NCT00926185|O4|Outcome|Placebo|
574244|NCT00926185|O3|Outcome|Lifitegrast 5.0%|
574245|NCT00926185|O2|Outcome|Lifitegrast 1.0%|
574246|NCT00926185|O1|Outcome|Lifitegrast 0.1%|
574247|NCT00926185|E4|Reported Event|Placebo|
574248|NCT00926185|E3|Reported Event|Lifitegrast 5.0%|
574249|NCT00926185|E2|Reported Event|Lifitegrast 1.0%|
574250|NCT00926185|E1|Reported Event|Lifitegrast 0.1%|
574251|NCT00926211|B1|Baseline|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
574252|NCT00926211|P1|Participant Flow|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
574253|NCT00926211|O2|Outcome|Computer-Assisted Harvest|Region of scalp with implanted follicles that were harvested using a computer-assisted system.
574254|NCT00926211|O1|Outcome|Manual Harvest|Region of scalp with implanted follicles that were manually harvested.
574255|NCT00926211|O2|Outcome|Computer-Assisted Harvest|Region of scalp with implanted follicles that were harvested using a computer-assisted system.
574256|NCT00926211|O1|Outcome|Manual Harvest|Region of scalp with implanted follicles that were manually harvested.
574257|NCT00926211|E1|Reported Event|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
574258|NCT00926263|B3|Baseline|Total|Total of all reporting groups
574259|NCT00926263|B2|Baseline|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574260|NCT00926263|B1|Baseline|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574261|NCT00926263|P2|Participant Flow|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574262|NCT00926263|P1|Participant Flow|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574460|NCT00926783|B3|Baseline|Total|Total of all reporting groups
574267|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574268|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574269|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574270|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574271|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574272|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574275|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574276|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574277|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574278|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574279|NCT00926263|O1|Outcome|CP-751,871 20/20 mg/kg|Participants not enrolled due to early termination of the study.
574280|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574281|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574282|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574283|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574284|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574285|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574286|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574287|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574288|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574289|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574290|NCT00926263|E2|Reported Event|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574291|NCT00926263|E1|Reported Event|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
574292|NCT00926289|B3|Baseline|Total|Total of all reporting groups
574293|NCT00926289|B2|Baseline|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574294|NCT00926289|B1|Baseline|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574295|NCT00926289|P2|Participant Flow|Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574296|NCT00926289|P1|Participant Flow|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574297|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574298|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574299|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574300|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574301|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574302|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574303|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574304|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574305|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574306|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574307|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574308|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574309|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574310|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574311|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574312|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574313|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574314|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574315|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574316|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574317|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574318|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574319|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574320|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574321|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574322|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574323|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574324|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574325|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574326|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574327|NCT00926289|E2|Reported Event|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
574328|NCT00926289|E1|Reported Event|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
574329|NCT00926328|B3|Baseline|Total|Total of all reporting groups
574330|NCT00926328|B2|Baseline|Placebo Control|sodium fluoride toothpaste
574331|NCT00926328|B1|Baseline|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
574332|NCT00926328|P2|Participant Flow|Placebo Control|sodium fluoride toothpaste
574333|NCT00926328|P1|Participant Flow|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
574334|NCT00926328|O2|Outcome|Placebo Control|sodium fluoride toothpaste
574335|NCT00926328|O1|Outcome|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
574336|NCT00926328|O2|Outcome|Placebo Control|sodium fluoride toothpaste
574337|NCT00926328|O1|Outcome|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
574338|NCT00926328|E2|Reported Event|Placebo Control|sodium fluoride toothpaste
574339|NCT00926328|E1|Reported Event|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
574340|NCT00926367|B3|Baseline|Total|Total of all reporting groups
574341|NCT00926367|B2|Baseline|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574342|NCT00926367|B1|Baseline|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574343|NCT00926367|P2|Participant Flow|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574344|NCT00926367|P1|Participant Flow|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574345|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574346|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574347|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574348|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574349|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574350|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574351|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574352|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574353|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574354|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574355|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574356|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574357|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574358|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574359|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574360|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574361|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574362|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574363|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574364|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574365|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574366|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574367|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574368|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574369|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574370|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574371|NCT00926367|O2|Outcome|Epiduo|Patients Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574372|NCT00926367|O1|Outcome|Duac|Patients Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574373|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574374|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574375|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574376|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574377|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574378|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574379|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574380|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574381|NCT00926367|E2|Reported Event|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
574382|NCT00926367|E1|Reported Event|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
574383|NCT00926393|B3|Baseline|Total|Total of all reporting groups
574384|NCT00926393|B2|Baseline|Quetiapine XR|Quetiapine fumarate Extended Release
574385|NCT00926393|B1|Baseline|Quetiapine IR|Quetiapine fumarate Immediate Release
574386|NCT00926393|P2|Participant Flow|Quetiapine XR|Quetiapine fumarate Extended Release
574387|NCT00926393|P1|Participant Flow|Quetiapine IR|Quetiapine fumarate Immediate Release
574388|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574389|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574390|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574391|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574392|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574393|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574394|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574395|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574396|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574397|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574398|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574399|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574400|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574401|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574402|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574403|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574404|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574405|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574406|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574407|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574408|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574409|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574410|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574411|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574412|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
574413|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
574414|NCT00926393|E2|Reported Event|Quetiapine XR|Quetiapine fumarate Extended Release
574415|NCT00926393|E1|Reported Event|Quetiapine IR|Quetiapine fumarate Immediate Release
574416|NCT00926497|B3|Baseline|Total|Total of all reporting groups
574417|NCT00926497|B2|Baseline|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
574418|NCT00926497|B1|Baseline|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
574419|NCT00926497|P2|Participant Flow|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
574420|NCT00926497|P1|Participant Flow|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
574421|NCT00926497|O2|Outcome|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
574422|NCT00926497|O1|Outcome|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
574423|NCT00926497|O2|Outcome|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
574424|NCT00926497|O1|Outcome|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
574425|NCT00926497|E2|Reported Event|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
574426|NCT00926497|E1|Reported Event|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
574427|NCT00926536|B3|Baseline|Total|Total of all reporting groups
574428|NCT00926536|B2|Baseline|DSA Only|DSA images only used for vessel navigation and tracking
574429|NCT00926536|B1|Baseline|C-arm CT + DSA as Needed|C-arm CT in imaging guidance of TACE supplemented by DSA as needed for vessel navigation and tracking
574430|NCT00926536|P2|Participant Flow|DSA Only|Only Digital subtraction images used for vessel tracking and tumor navigation
574431|NCT00926536|P1|Participant Flow|C-arm CT +DSA as Needed|C-arm CT in imaging guidance of TACE supplemented with DSA as needed for vessel tracking and navigation
574432|NCT00926536|O2|Outcome|DSA Only|Only DSA imaging used for navigational purposes
574433|NCT00926536|O1|Outcome|C-arm CT +DSA as Needed|C-arm CT images used for navigational purposes supplemented by DSA if needed
574434|NCT00926536|O2|Outcome|DSA Only|Only DSA imaging used for navigational purposes
574435|NCT00926536|O1|Outcome|C-arm CT +DSA as Needed|C-arm CT images used for navigational purposes supplemented by DSA if needed
574436|NCT00926536|E2|Reported Event|DSA Only|DSA only used for navigation
574437|NCT00926536|E1|Reported Event|C-arm CT + DSA as Needed|C-arm CT used for the purposes of navigation, supplemented by DSA if needed
574438|NCT00926575|B3|Baseline|Total|Total of all reporting groups
574439|NCT00926575|B2|Baseline|Placebo|
574440|NCT00926575|B1|Baseline|Active|oral beclomethasone 17,21-dipropionate (BDP)
574441|NCT00926575|P2|Participant Flow|Placebo|
574442|NCT00926575|P1|Participant Flow|Active|oral beclomethasone 17,21-dipropionate (BDP)
574443|NCT00926575|O2|Outcome|Placebo|
574444|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
574445|NCT00926575|O2|Outcome|Placebo|
574446|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
574447|NCT00926575|O2|Outcome|Placebo|
574448|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
574449|NCT00926575|E2|Reported Event|Placebo|
574450|NCT00926575|E1|Reported Event|Active|oral beclomethasone 17,21-dipropionate (BDP)
574451|NCT00926588|B3|Baseline|Total|Total of all reporting groups
574452|NCT00926588|B2|Baseline|Usual Care|Patients receive usual care for pain from their primary care physician
574453|NCT00926588|B1|Baseline|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.
Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
574454|NCT00926588|P2|Participant Flow|Usual Care|Patients receive usual care for pain from their primary care physician
574455|NCT00926588|P1|Participant Flow|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.
Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
574456|NCT00926588|O2|Outcome|Usual Care|Patients receive usual care for pain from their primary care physician
574457|NCT00926588|O1|Outcome|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.
Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
574458|NCT00926588|E2|Reported Event|Usual Care|Patients receive usual care for pain from their primary care physician
574459|NCT00926588|E1|Reported Event|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.
Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
574461|NCT00926783|B2|Baseline|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
574462|NCT00926783|B1|Baseline|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
574516|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574552|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574463|NCT00926783|P2|Participant Flow|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
574464|NCT00926783|P1|Participant Flow|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
574465|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
574466|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
574467|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
574468|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
574469|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
574470|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
574471|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
574472|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
574473|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
574474|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
574475|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
574511|NCT00926887|O1|Outcome|Placebo Laser|inactive light
574476|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
574477|NCT00926783|E2|Reported Event|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
574478|NCT00926783|E1|Reported Event|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
574479|NCT00926796|B3|Baseline|Total|Total of all reporting groups
574480|NCT00926796|B2|Baseline|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
574481|NCT00926796|B1|Baseline|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
574482|NCT00926796|P2|Participant Flow|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
574483|NCT00926796|P1|Participant Flow|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
574484|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
574485|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
574486|NCT00926796|O1|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
574487|NCT00926796|O1|Outcome|Baseline|All per protocol participants at baseline with evaluable isolates
574488|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
574489|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
574490|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
574491|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
574492|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
574493|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
574494|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
574495|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
574496|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
574497|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
574498|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
574499|NCT00926796|E2|Reported Event|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
574500|NCT00926796|E1|Reported Event|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
574501|NCT00926887|B3|Baseline|Total|Total of all reporting groups
574502|NCT00926887|B2|Baseline|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
574503|NCT00926887|B1|Baseline|Placebo Laser|inactive light
574504|NCT00926887|P2|Participant Flow|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
574505|NCT00926887|P1|Participant Flow|Placebo Laser|inactive light
574506|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
574507|NCT00926887|O1|Outcome|Placebo Laser|inactive light
574508|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
574509|NCT00926887|O1|Outcome|Placebo Laser|inactive light
574510|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
574512|NCT00926887|E2|Reported Event|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
574513|NCT00926887|E1|Reported Event|Placebo Laser|inactive light
574514|NCT00926952|B1|Baseline|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574515|NCT00926952|P1|Participant Flow|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574551|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574517|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574518|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574519|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574520|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574521|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574522|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574523|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574524|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574525|NCT00926952|E1|Reported Event|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
574526|NCT00927069|B3|Baseline|Total|Total of all reporting groups
574527|NCT00927069|B2|Baseline|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
574528|NCT00927069|B1|Baseline|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
574529|NCT00927069|P4|Participant Flow|Groupe B Dose Increase at Week 12|Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
574530|NCT00927069|P3|Participant Flow|Groupe A Dose Increase at Week 12|Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
574531|NCT00927069|P2|Participant Flow|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
574532|NCT00927069|P1|Participant Flow|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
574533|NCT00927069|O2|Outcome|Group B|Patients at screening had shown a satisfactory response to etanercept 50mg twice a week followed by a loss of response after dose reduction to 50mg etanercept once a week.
574534|NCT00927069|O1|Outcome|Group A|Patients at screening had shown an unsastifactory response after 3 months of etanercept 50mg twice a week.
574535|NCT00927069|O1|Outcome|Groupe A Dose Increase at Week 12|Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
574536|NCT00927069|O1|Outcome|Groupe B Dose Increase at Week 12|Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
574537|NCT00927069|O1|Outcome|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
574538|NCT00927069|O1|Outcome|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
574539|NCT00927069|E2|Reported Event|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
574540|NCT00927069|E1|Reported Event|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening.
574541|NCT00927082|B5|Baseline|Total|Total of all reporting groups
574542|NCT00927082|B4|Baseline|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574543|NCT00927082|B3|Baseline|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574544|NCT00927082|B2|Baseline|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574545|NCT00927082|B1|Baseline|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574546|NCT00927082|P4|Participant Flow|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574547|NCT00927082|P3|Participant Flow|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574548|NCT00927082|P2|Participant Flow|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574549|NCT00927082|P1|Participant Flow|PEG-IFN 90mcg 24 Wks|Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
574550|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574553|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574554|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574555|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574556|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574557|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574558|NCT00927082|O4|Outcome|Group D|Participants received 180 mcg PEG-IFN SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574559|NCT00927082|O3|Outcome|Group C|Participants received 90 mcg PEG-IFN SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574560|NCT00927082|O2|Outcome|Group B|Participants received 180 mcg PEG-IFN SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574561|NCT00927082|O1|Outcome|Group A|Participants received 90 mcg PEG-IFN SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574562|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574563|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574564|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574565|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574566|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574567|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574568|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574569|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574570|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574571|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574572|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574573|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574574|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574575|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574576|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574577|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574578|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574579|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574580|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574581|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574582|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574583|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574584|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574585|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574586|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574587|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574588|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574589|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574590|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574591|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574592|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574593|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574594|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
575631|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
574595|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574596|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574597|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574598|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574599|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574600|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574601|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574602|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574603|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574604|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574605|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574606|NCT00927082|E4|Reported Event|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574607|NCT00927082|E3|Reported Event|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
574608|NCT00927082|E2|Reported Event|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574609|NCT00927082|E1|Reported Event|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
574610|NCT00927095|B4|Baseline|Total|Total of all reporting groups
574611|NCT00927095|B3|Baseline|Continuous Placebo|"continuous placebo
placebo: daily"
574612|NCT00927095|B2|Baseline|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)
20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
574613|NCT00927095|B1|Baseline|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive
low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
574614|NCT00927095|P3|Participant Flow|Continuous Placebo|"continuous placebo
placebo: daily"
574615|NCT00927095|P2|Participant Flow|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)
20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
574616|NCT00927095|P1|Participant Flow|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive
low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
574617|NCT00927095|O3|Outcome|Continuous Placebo|"continuous placebo
placebo: daily"
574618|NCT00927095|O2|Outcome|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)
20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
574619|NCT00927095|O1|Outcome|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive
low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
574620|NCT00927095|E3|Reported Event|Continuous Placebo|"continuous placebo
placebo: daily"
574621|NCT00927095|E2|Reported Event|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)
20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
574622|NCT00927095|E1|Reported Event|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive
low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
574623|NCT00927160|B3|Baseline|Total|Total of all reporting groups
574624|NCT00927160|B2|Baseline|Usual Care Group|Elderly patients admitted to the general medicine service in the hospital
574625|NCT00927160|B1|Baseline|MACE Group|Elderly patients admitted to the Mobile Acute Care of the Elderly Unit.
574626|NCT00927160|P2|Participant Flow|Usual Care Group|Elderly patients admitted to the general medicine service in the hospital
574627|NCT00927160|P1|Participant Flow|MACE Group|Elderly patients admitted to the Mobile Acute Care of the Elderly Unit.
574628|NCT00927160|O2|Outcome|Usual Care|Matching group of patients admitted to general medical service
574629|NCT00927160|O1|Outcome|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
574630|NCT00927160|O2|Outcome|Usual Care|Matching group of patients admitted to general medical service
574631|NCT00927160|O1|Outcome|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
574632|NCT00927160|E2|Reported Event|Usual Care|Matching group of patients admitted to general medical service
574633|NCT00927160|E1|Reported Event|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
574634|NCT00927186|B3|Baseline|Total|Total of all reporting groups
574635|NCT00927186|B2|Baseline|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574636|NCT00927186|B1|Baseline|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574637|NCT00927186|P2|Participant Flow|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574638|NCT00927186|P1|Participant Flow|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574639|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574640|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574641|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574642|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574643|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574644|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574645|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574646|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574647|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574648|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574649|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574650|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574651|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574652|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574653|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574654|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574655|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574656|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574657|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574658|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574659|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574660|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574792|NCT00927355|O1|Outcome|Pioglitazone-Osteoblast CFU (Colony Forming Units)|Percent change in Osteoblast CFU numbers as stained with Alizarin red S at baseline and 6 months after treatment with study drug.
574661|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574662|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574663|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574664|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574665|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574666|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574667|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574668|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574669|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574670|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574671|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574672|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574673|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574674|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574675|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574676|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574677|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574678|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574679|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574680|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574681|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574682|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574683|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574684|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574685|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574686|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574687|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574688|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574689|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574690|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574691|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574692|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574693|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574694|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574695|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574696|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574697|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574698|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574699|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574700|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574701|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574702|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574703|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574704|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574705|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension"
574706|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574707|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574708|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574709|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574710|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574711|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574712|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574713|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574714|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574715|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574716|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574717|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574718|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574719|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574720|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574721|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574722|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574723|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574724|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574725|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574726|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574727|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574728|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574729|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574730|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574731|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574732|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574733|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574734|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574735|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574736|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574737|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574738|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574739|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574740|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574741|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574742|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574743|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574744|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574745|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574746|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574747|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574748|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
574749|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574750|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574751|NCT00927186|E2|Reported Event|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574752|NCT00927186|E1|Reported Event|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
574766|NCT00927264|O2|Outcome|Education Only|"Participants will receive only educational program for ETS reduction.
Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
574753|NCT00927251|B1|Baseline|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
574793|NCT00927355|E2|Reported Event|Placebo|The other half will be randomized to placebo.
574794|NCT00927355|E1|Reported Event|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
574754|NCT00927251|P1|Participant Flow|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
574755|NCT00927251|O1|Outcome|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
574756|NCT00927251|E1|Reported Event|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
574757|NCT00927264|B3|Baseline|Total|Total of all reporting groups
574758|NCT00927264|B2|Baseline|Education Only|"Caregivers will receive only educational program for ETS reduction.
Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
574759|NCT00927264|B1|Baseline|Behavioral|"Motivational Interviewing Intervention Plus Education
Caregivers of children will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.
Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor. Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
574760|NCT00927264|P2|Participant Flow|Education Only|"Participants will receive only educational program for ETS reduction.
Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
574761|NCT00927264|P1|Participant Flow|Behavioral|"Motivational Interviewing Intervention Plus Education
Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.
Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
574762|NCT00927264|O2|Outcome|Education Only|"Caregivers will receive only educational program for ETS reduction.
Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
574763|NCT00927264|O1|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education
Caregivers of children will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.
Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor. Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
574764|NCT00927264|O2|Outcome|Education Only|"Caregivers will receive only educational program for ETS reduction.
Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
574765|NCT00927264|O1|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education
Caregivers of children will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.
Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor. Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
575611|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
574795|NCT00927368|B4|Baseline|Total|Total of all reporting groups
574831|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574767|NCT00927264|O1|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education
Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.
Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
574768|NCT00927264|O2|Outcome|Education Only|"Participants will receive only educational program for ETS reduction.
Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
574769|NCT00927264|O1|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education
Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.
Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
574770|NCT00927264|O2|Outcome|Education Only|"Participants will receive only educational program for ETS reduction.
Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
574771|NCT00927264|O1|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education
Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.
Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
574772|NCT00927264|E2|Reported Event|Education Only|"Participants will receive only educational program for ETS reduction.
Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
574773|NCT00927264|E1|Reported Event|Behavioral|"Motivational Interviewing Intervention Plus Education
Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.
Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
574774|NCT00927355|B3|Baseline|Total|Total of all reporting groups
574775|NCT00927355|B2|Baseline|Placebo|The other half will be randomized to placebo.
574776|NCT00927355|B1|Baseline|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
574777|NCT00927355|P2|Participant Flow|Placebo|The other half will be randomized to placebo, starting out with 15mg qday for 4 weeks and if no adverse effects noted increased to 30mg qday for 5 more months.
574778|NCT00927355|P1|Participant Flow|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months starting out with 15mg qday for 4 weeks and if no adverse effects noted increased to 30mg qday for 5 more months.
574779|NCT00927355|O4|Outcome|Placebo - Lumbar Spine BMD|The other half will be randomized to placebo.
574780|NCT00927355|O3|Outcome|Pioglitazone -Lumbar Spine BMD|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
574781|NCT00927355|O2|Outcome|Placebo-Femoral Neck BMD|The other half will be randomized to placebo.
574782|NCT00927355|O1|Outcome|Pioglitazone-Femoral Neck BMD|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
574783|NCT00927355|O6|Outcome|Placebo - Osc|serum Osteocalcin percent change 6 mo after placebo Rx compared to baseline.
574784|NCT00927355|O5|Outcome|Pioglitazone-OSc|serum Osteocalcin percent change 6 mo after pioglitazone Rx compared to baseline.
574785|NCT00927355|O4|Outcome|Placebo-CTX|serum CTX percent change 6 mo after placebo Rx compared to baseline.
574786|NCT00927355|O3|Outcome|Pioglitazone-CTX|serum CTX percent change 6 mo after pioglitazone Rx compared to baseline.
574787|NCT00927355|O2|Outcome|Placebo-Adiponectin|serum adiponectin percent change 6 mo after placebo Rx compared to baseline.
574788|NCT00927355|O1|Outcome|Pioglitazone-Adiponectin|serum adiponectin percent change 6 mo after study drug Rx compared to baseline.
574789|NCT00927355|O4|Outcome|Placebo-Adipocyte CFU|Percent change in adipocyte CFU numbers as stained with Oil red O, at baseline and 6 months after treatment with study drug.
574790|NCT00927355|O3|Outcome|Pioglitazone-Adipocyte CFU|Percent change in adipocyte CFU numbers as stained with Oil red O at baseline and 6 months after treatment with study drug.
574791|NCT00927355|O2|Outcome|Placebo-OSteoblast CFU|Percent change in Osteoblast CFU numbers as stained with Alizarin at baseline and 6 months after treatment with study drug.
574879|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks"
574796|NCT00927368|B3|Baseline|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
574797|NCT00927368|B2|Baseline|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation
ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
574798|NCT00927368|B1|Baseline|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.
ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
574799|NCT00927368|P3|Participant Flow|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
574800|NCT00927368|P2|Participant Flow|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation
ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
574801|NCT00927368|P1|Participant Flow|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.
ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
574802|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
574803|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation
ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
574804|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.
ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
574830|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574848|NCT00927472|B3|Baseline|Total|Total of all reporting groups
575632|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
574805|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
574806|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation
ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
574807|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.
ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
574808|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
574809|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation
ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
574810|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.
ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
574811|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
574812|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation
ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
574813|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.
ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
574829|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574880|NCT00927563|E1|Reported Event|Tolcapone|"Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks"
574881|NCT00927576|B3|Baseline|Total|Total of all reporting groups
574814|NCT00927368|E3|Reported Event|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
574815|NCT00927368|E2|Reported Event|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation
ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
574816|NCT00927368|E1|Reported Event|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.
ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
574817|NCT00927394|B3|Baseline|Total|Total of all reporting groups
574818|NCT00927394|B2|Baseline|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574819|NCT00927394|B1|Baseline|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574820|NCT00927394|P2|Participant Flow|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574821|NCT00927394|P1|Participant Flow|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574822|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574823|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574824|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574825|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574826|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574827|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574828|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574832|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574833|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574834|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574835|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574836|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574837|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574838|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574839|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574840|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574841|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574842|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574843|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574844|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574845|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
574846|NCT00927394|E2|Reported Event|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
574847|NCT00927394|E1|Reported Event|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks.
574849|NCT00927472|B2|Baseline|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574850|NCT00927472|B1|Baseline|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574851|NCT00927472|P2|Participant Flow|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574852|NCT00927472|P1|Participant Flow|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574853|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574854|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574855|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574856|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574857|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574858|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574859|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574860|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574861|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574862|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574863|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574864|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574865|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574866|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574867|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574868|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574869|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574870|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574871|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574872|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574873|NCT00927472|E2|Reported Event|Nix Creme Rinse|"Nix applied to scalp for 10 minutes
Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
574874|NCT00927472|E1|Reported Event|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
574875|NCT00927563|B1|Baseline|Tolcapone|"Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks"
574876|NCT00927563|P1|Participant Flow|Tolcapone|"Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks"
574877|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks"
574878|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks"
574882|NCT00927576|B2|Baseline|TBI Patients|TBI patients N = 30. Mixed mild and severe TBI group, with most showing PTSD comorbidity.
574883|NCT00927576|B1|Baseline|Control Subjects|Control subjects = 230. Normal control subjects of various ages.
574884|NCT00927576|P2|Participant Flow|TBI Patients|TBI patients N = 28. These patients underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.
574925|NCT00927823|P4|Participant Flow|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574885|NCT00927576|P1|Participant Flow|Control Subjects|Control subjects = 237. These subjects underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.
574886|NCT00927576|O1|Outcome|Simple Reaction Time Test|time to respond in ms to visual stimuli presented randomly to the left or right hemifield at varying stimulus onset asynchronies.
574887|NCT00927576|E2|Reported Event|TBI Patients|TBI patients N = 28. No adverse events were observed
574888|NCT00927576|E1|Reported Event|Control Subjects|Control subjects = 237. No adverse events were observed.
574889|NCT00927589|B1|Baseline|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574890|NCT00927589|P1|Participant Flow|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 milligrams per kilogram (mg/kg) of body weight given by intravenous (IV) infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 milligrams per square meter (mg/m^2) of body surface area (BSA) on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target area under the concentration-versus-time curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574891|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574892|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574893|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574894|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574895|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574896|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574924|NCT00927823|B1|Baseline|Entire Study Population|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
575037|NCT00927888|O1|Outcome|1 - Bupivacaine Block|"3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)
Bupivacaine Block: Bupivacaine local anesthesia block prior to start of FESS procedure."
574897|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574898|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574899|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574900|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574901|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574902|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574903|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574904|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574905|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574906|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
575030|NCT00927888|B2|Baseline|Group 2 - Saline Placebo Group|Saline substituted in block, placebo treatment group with application of saline block before FESS.
574907|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574908|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574909|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574910|NCT00927589|E1|Reported Event|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
574911|NCT00927758|B1|Baseline|All Randomized Patients|Baseline measured for all randomized (safety set) patients.
574912|NCT00927758|P6|Participant Flow|Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles."
574913|NCT00927758|P5|Participant Flow|Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles."
574914|NCT00927758|P4|Participant Flow|Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles."
574915|NCT00927758|P3|Participant Flow|Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles."
574916|NCT00927758|P2|Participant Flow|Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles."
574917|NCT00927758|P1|Participant Flow|Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for
7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for
7 days.
Treatment Cycle 3: Patient randomized to Fluticasone
Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for
7 days.
There were 14 days washout period between cycles."
574918|NCT00927758|O3|Outcome|Flu/Sal- 500mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
574919|NCT00927758|O2|Outcome|Flu/Sal- 250mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
574920|NCT00927758|O1|Outcome|Flu/Sal- 100mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
574921|NCT00927758|E3|Reported Event|Flu/Sal- 500mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
574922|NCT00927758|E2|Reported Event|Flu/Sal- 250mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
574923|NCT00927758|E1|Reported Event|Flu/Sal- 100mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
575031|NCT00927888|B1|Baseline|Group 1 Bupivacaine|Active treatment group with application of bupivacaine block before FESS.
574926|NCT00927823|P3|Participant Flow|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574927|NCT00927823|P2|Participant Flow|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574928|NCT00927823|P1|Participant Flow|PF-04691502 2 mg|Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574929|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574930|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574931|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574932|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574933|NCT00927823|O1|Outcome|PF-04691502|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574934|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574935|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574936|NCT00927823|O2|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574937|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574938|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574939|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574940|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574941|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574942|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574943|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574944|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
575612|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
574945|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574946|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574947|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574948|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574949|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574950|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574951|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574952|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574953|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574954|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574955|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574956|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574957|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574958|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574959|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574960|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574961|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574962|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 11 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
574963|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 8 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
574964|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 4 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
574965|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 2 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
574966|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
575032|NCT00927888|P2|Participant Flow|Group 2 - Placebo Saline Block|This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.
574967|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574968|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574969|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574970|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574971|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574972|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574973|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574974|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574975|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574976|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574977|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574978|NCT00927823|O1|Outcome|PF-04691502|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574979|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574980|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574981|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574982|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574983|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574984|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574985|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574986|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574987|NCT00927823|E4|Reported Event|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
575033|NCT00927888|P1|Participant Flow|Group 1 - Bupivacaine Block|Active treatment group with application of bupivacaine block before FESS.
574988|NCT00927823|E3|Reported Event|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574989|NCT00927823|E2|Reported Event|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574990|NCT00927823|E1|Reported Event|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
574991|NCT00927849|B4|Baseline|Total|Total of all reporting groups
574992|NCT00927849|B3|Baseline|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
574993|NCT00927849|B2|Baseline|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
574994|NCT00927849|B1|Baseline|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
574995|NCT00927849|P3|Participant Flow|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
574996|NCT00927849|P2|Participant Flow|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
574997|NCT00927849|P1|Participant Flow|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
574998|NCT00927849|O3|Outcome|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
574999|NCT00927849|O2|Outcome|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
575000|NCT00927849|O1|Outcome|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
575001|NCT00927849|E3|Reported Event|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
575002|NCT00927849|E2|Reported Event|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
575003|NCT00927849|E1|Reported Event|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
575004|NCT00927862|B3|Baseline|Total|Total of all reporting groups
575005|NCT00927862|B2|Baseline|Historical Controls|A parallel, clinical effectiveness comparison group that used an algorithm with standard dosing
575006|NCT00927862|B1|Baseline|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the pharmacogenetic (PG)-dosing algorithms (standard or modified IWPC warfarin algorithms)
575007|NCT00927862|P2|Participant Flow|Parellel/Historical Controls|A parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized pharmacogenetic-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified.
575008|NCT00927862|P1|Participant Flow|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms were randomized to receive either standard or modified International Warfarin Pharmacogenetics Consortium [IWPC] warfarin dosing. The IWPC derived and published a common algorithm to predict stable maintenance dose based on ~5000 patients across broad geographic and ethnic/racial groups (N Engl J Med 2009;360:753-764). Hence, we based our standard algorithm on the IWPC algorithm with minor modifications to accommodate different INR targets and smoking status, based on supplemental data from Gage et al (Clini Pharmacol Ther 2008;84:326 -331). The modified IWPC algorithm included 2 further modifications: (1) It ignored the CYP2C9 variant status for the first 2 days; and (2) It used a special dose-revision algorithm based on a day 4 (or day 5) INR after 3 (or 4) warfarin doses.
575034|NCT00927888|O2|Outcome|Group 2 - Placebo Saline Block|This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.
575035|NCT00927888|O1|Outcome|Group 1 - Bupivacaine Block|Active treatment group with application of bupivacaine block before FESS.
575036|NCT00927888|O2|Outcome|2 - Placebo|Normal saline with Epi 1:100,000 (B block)
575613|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575038|NCT00927888|E2|Reported Event|Group 2 - Saline Placebo Block|Placebo treatment group with application of saline block before FESS.
575039|NCT00927888|E1|Reported Event|Group 1 - Bupicaine Block|Active treatment group with application of bupivacaine block before FESS.
575077|NCT00927927|B10|Baseline|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
575078|NCT00927927|B9|Baseline|SD Placebo|Subjects were dosed once with placebo
575079|NCT00927927|B8|Baseline|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
575009|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
575010|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
575011|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
575012|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
575013|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
575014|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
575015|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
575016|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
575017|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
575018|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
575019|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
575020|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
575021|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
575022|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
575023|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
575024|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
575025|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
575026|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
575027|NCT00927862|E2|Reported Event|Historical Controls|A parallel, clinical effectiveness comparison group that used an algorithm with standard dosing
575028|NCT00927862|E1|Reported Event|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the pharmacogenetic (PG)-dosing algorithms (standard or modified IWPC warfarin algorithms)
575029|NCT00927888|B3|Baseline|Total|Total of all reporting groups
575040|NCT00927901|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received the 3 salt forms of indacaterol 400 µg (maleate, acetate, and xinafoate) and placebo to indacaterol in 4 different sequences. The dose refers to 400 μg of free base indacaterol. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575041|NCT00927901|P4|Participant Flow|Placebo-indacaterol (Ind) Acetate-ind Maleate-ind Xinafoate|In treatment period 1, patients received placebo to indacaterol; in treatment period 2, patients received indacaterol acetate 400 μg; in treatment period 3, patients received indacaterol maleate 400 μg; and in treatment period 4, patients received indacaterol xinafoate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575042|NCT00927901|P3|Participant Flow|Indacaterol (Ind) Acetate-ind Xinafoate-placebo-ind Maleate|In treatment period 1, patients received indacaterol acetate 400 μg; in treatment period 2, patients received indacaterol xinafoate 400 μg; in treatment period 3, patients received placebo to indacaterol; and in treatment period 4, patients received indacaterol maleate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575043|NCT00927901|P2|Participant Flow|Indacaterol (Ind) Xinafoate-ind Maleate-ind Acetate-placebo|In treatment period 1, patients received indacaterol xinafoate 400 μg; in treatment period 2, patients received indacaterol maleate 400 μg; in treatment period 3, patients received indacaterol acetate 400 μg; and in treatment period 4, patients received placebo to indacaterol 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575044|NCT00927901|P1|Participant Flow|Indacaterol (Ind) Maleate-placebo-ind Xinafoate-ind Acetate|In treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575045|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575046|NCT00927901|O2|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575047|NCT00927901|O1|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575048|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575049|NCT00927901|O2|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575050|NCT00927901|O1|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575051|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575052|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575071|NCT00927927|B16|Baseline|Total|Total of all reporting groups
575053|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|3Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575633|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575054|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575055|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575056|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575057|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575058|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575059|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575060|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575061|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575062|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575063|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575064|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575065|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575066|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575067|NCT00927901|E4|Reported Event|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575068|NCT00927901|E3|Reported Event|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575069|NCT00927901|E2|Reported Event|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575070|NCT00927901|E1|Reported Event|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
575073|NCT00927927|B14|Baseline|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
575074|NCT00927927|B13|Baseline|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
575075|NCT00927927|B12|Baseline|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
575080|NCT00927927|B7|Baseline|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
575081|NCT00927927|B6|Baseline|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
575082|NCT00927927|B5|Baseline|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
575083|NCT00927927|B4|Baseline|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
575084|NCT00927927|B3|Baseline|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
575085|NCT00927927|B2|Baseline|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
575086|NCT00927927|B1|Baseline|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
575087|NCT00927927|P15|Participant Flow|MD Placebo|Subjects were injected biweekly four times with placebo
575088|NCT00927927|P14|Participant Flow|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
575089|NCT00927927|P13|Participant Flow|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
575090|NCT00927927|P12|Participant Flow|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
575091|NCT00927927|P11|Participant Flow|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
575092|NCT00927927|P10|Participant Flow|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
575093|NCT00927927|P9|Participant Flow|SD Placebo|Subjects were dosed once with placebo
575094|NCT00927927|P8|Participant Flow|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
575095|NCT00927927|P7|Participant Flow|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
575096|NCT00927927|P6|Participant Flow|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
575097|NCT00927927|P5|Participant Flow|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
575098|NCT00927927|P4|Participant Flow|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
575099|NCT00927927|P3|Participant Flow|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
575100|NCT00927927|P2|Participant Flow|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
575101|NCT00927927|P1|Participant Flow|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
575102|NCT00927927|O15|Outcome|MD Placebo|Subjects were injected biweekly four times with placebo
575103|NCT00927927|O14|Outcome|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
575104|NCT00927927|O13|Outcome|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
575105|NCT00927927|O12|Outcome|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
575106|NCT00927927|O11|Outcome|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
575107|NCT00927927|O10|Outcome|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
575108|NCT00927927|O9|Outcome|SD Placebo|Subjects were dosed once with placebo
575109|NCT00927927|O8|Outcome|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
575110|NCT00927927|O7|Outcome|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
575111|NCT00927927|O6|Outcome|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
575112|NCT00927927|O5|Outcome|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
575113|NCT00927927|O4|Outcome|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
575114|NCT00927927|O3|Outcome|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
575115|NCT00927927|O2|Outcome|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
575116|NCT00927927|O1|Outcome|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
575117|NCT00927927|O15|Outcome|MD Placebo|Subjects were injected biweekly four times with placebo
575118|NCT00927927|O14|Outcome|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
575119|NCT00927927|O13|Outcome|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
575120|NCT00927927|O12|Outcome|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
575121|NCT00927927|O11|Outcome|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
575122|NCT00927927|O10|Outcome|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
575123|NCT00927927|O9|Outcome|SD Placebo|Subjects were dosed once with placebo
575124|NCT00927927|O8|Outcome|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
575125|NCT00927927|O7|Outcome|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
575126|NCT00927927|O6|Outcome|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
575127|NCT00927927|O5|Outcome|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
575128|NCT00927927|O4|Outcome|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
575129|NCT00927927|O3|Outcome|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
575130|NCT00927927|O2|Outcome|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
575131|NCT00927927|O1|Outcome|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
575132|NCT00927927|E15|Reported Event|MD Placebo|Subjects were injected biweekly four times with placebo
575133|NCT00927927|E14|Reported Event|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
575134|NCT00927927|E13|Reported Event|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
575135|NCT00927927|E12|Reported Event|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
575136|NCT00927927|E11|Reported Event|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
575137|NCT00927927|E10|Reported Event|SD Placebo|Subjects were dosed once with placebo
575138|NCT00927927|E9|Reported Event|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
575139|NCT00927927|E8|Reported Event|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
575140|NCT00927927|E7|Reported Event|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
575141|NCT00927927|E6|Reported Event|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
575142|NCT00927927|E5|Reported Event|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
575143|NCT00927927|E4|Reported Event|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
575144|NCT00927927|E3|Reported Event|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
575145|NCT00927927|E2|Reported Event|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
575146|NCT00927927|E1|Reported Event|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
575147|NCT00927940|B1|Baseline|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
575148|NCT00927940|P1|Participant Flow|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
575149|NCT00927940|O1|Outcome|Zotarolims Eluting Stent|
575150|NCT00927940|O1|Outcome|Zotarolimus Eluting Stent|100 lesion of 100 ITT patients were subjected for this analysis.
575151|NCT00927940|E1|Reported Event|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
575152|NCT00927953|B3|Baseline|Total|Total of all reporting groups
575153|NCT00927953|B2|Baseline|Placebo - Normal Saline|single intravenous infusion of saline placebo
575154|NCT00927953|B1|Baseline|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
575155|NCT00927953|P2|Participant Flow|Placebo - Normal Saline|single intravenous infusion of saline placebo
575156|NCT00927953|P1|Participant Flow|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
575157|NCT00927953|O2|Outcome|Placebo-Normal Saline|single intravenous infusion of saline placebo
575158|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
575159|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
575160|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
575161|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
575162|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
575163|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
575164|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
575165|NCT00927953|O2|Outcome|Placebo-Normal Saline|single intravenous infusion of saline placebo
575166|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
575167|NCT00927953|E2|Reported Event|Placebo - Normal Saline|single intravenous infusion of saline placebo
575168|NCT00927953|E1|Reported Event|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
575169|NCT00927992|B1|Baseline|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
575170|NCT00927992|P1|Participant Flow|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
575171|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
575172|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
575173|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
575174|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
575175|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
575176|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
575177|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
575178|NCT00927992|E1|Reported Event|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
575179|NCT00928018|B3|Baseline|Total|Total of all reporting groups
575180|NCT00928018|B2|Baseline|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:
Control Arm 1: tacrolimus + methotrexate
Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.
Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.
Control Arm 2: cyclosporine + MMF
Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.
MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months
Cyclosporine: Taken orally or given intravenously for at least 6 months
MMF: Taken orally for about 2 months"
575181|NCT00928018|B1|Baseline|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:
Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate
Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.
Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.
Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.
Sirolimus: Taken orally for at least 12 months
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months"
575182|NCT00928018|P2|Participant Flow|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:
Control Arm 1: tacrolimus + methotrexate
Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.
Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.
Control Arm 2: cyclosporine + MMF
Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.
MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months
Cyclosporine: Taken orally or given intravenously for at least 6 months
MMF: Taken orally for about 2 months"
575183|NCT00928018|P1|Participant Flow|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:
Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate
Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.
Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.
Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.
Sirolimus: Taken orally for at least 12 months
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months"
575184|NCT00928018|O4|Outcome|Aggressive Group: Sirolimus-Free Regimen|"Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies
There are two choices for the Sirolimus free arm:
Control Arm 1: tacrolimus + methotrexate
Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months
Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.
Control Arm 2: cyclosporine + MMF
Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months
MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months."
575185|NCT00928018|O3|Outcome|Aggressive Group: Sirolimus-Containing Regimen|"Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies
The Sirolimus containing arm will consist of the following drugs:
Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate
Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months
Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months
Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant"
575186|NCT00928018|O2|Outcome|Indolent Group: Sirolimus-Free Regimen|"Indolent group: indolent B-cell NHL, CLL and HL histologies
There are two choices for the Sirolimus free arm:
Control Arm 1: tacrolimus + methotrexate
Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months
Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.
Control Arm 2: cyclosporine + MMF
Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months
MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months."
575187|NCT00928018|O1|Outcome|Indolent Group: Sirolimus-Containing Regimen|"Indolent group:indolent B-cell NHL, CLL and HL histologies
The Sirolimus containing arm will consist of the following drugs:
Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate
Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months
Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months
Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant"
575227|NCT00928070|B2|Baseline|Fesoterodine|Participants who received fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575228|NCT00928070|B1|Baseline|Placebo|Participants who received placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575296|NCT00928083|P2|Participant Flow|Part A - OZ439 Single Dose - Cohort 2|OZ439 50 mg, then 100 mg, then 400 mg, then 1200 mg, then Placebo
575188|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:
Control Arm 1: tacrolimus + methotrexate
Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.
Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.
Control Arm 2: cyclosporine + MMF
Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.
MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months
Cyclosporine: Taken orally or given intravenously for at least 6 months
MMF: Taken orally for about 2 months"
575189|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:
Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate
Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.
Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.
Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.
Sirolimus: Taken orally for at least 12 months
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months"
575190|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:
Control Arm 1: tacrolimus + methotrexate
Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.
Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.
Control Arm 2: cyclosporine + MMF
Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.
MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months
Cyclosporine: Taken orally or given intravenously for at least 6 months
MMF: Taken orally for about 2 months"
575191|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:
Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate
Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.
Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.
Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.
Sirolimus: Taken orally for at least 12 months
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months"
575192|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:
Control Arm 1: tacrolimus + methotrexate
Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.
Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.
Control Arm 2: cyclosporine + MMF
Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.
MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months
Cyclosporine: Taken orally or given intravenously for at least 6 months
MMF: Taken orally for about 2 months"
575193|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:
Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate
Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.
Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.
Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.
Sirolimus: Taken orally for at least 12 months
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months"
575194|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:
Control Arm 1: tacrolimus + methotrexate
Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.
Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.
Control Arm 2: cyclosporine + MMF
Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.
MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months
Cyclosporine: Taken orally or given intravenously for at least 6 months
MMF: Taken orally for about 2 months"
575195|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:
Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate
Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.
Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.
Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.
Sirolimus: Taken orally for at least 12 months
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months"
575229|NCT00928070|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575230|NCT00928070|P1|Participant Flow|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575231|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575196|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:
Control Arm 1: tacrolimus + methotrexate
Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.
Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.
Control Arm 2: cyclosporine + MMF
Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.
MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months
Cyclosporine: Taken orally or given intravenously for at least 6 months
MMF: Taken orally for about 2 months"
575197|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:
Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate
Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.
Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.
Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.
Sirolimus: Taken orally for at least 12 months
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months"
575198|NCT00928018|E2|Reported Event|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:
Control Arm 1: tacrolimus + methotrexate
Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.
Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.
Control Arm 2: cyclosporine + MMF
Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.
MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months
Cyclosporine: Taken orally or given intravenously for at least 6 months
MMF: Taken orally for about 2 months"
575199|NCT00928018|E1|Reported Event|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:
Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate
Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.
Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.
Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.
Sirolimus: Taken orally for at least 12 months
Methotrexate: Given intravenously on the first, third and sixth day after transplant
Tacrolimus: Taken orally or given intravenously for at least 6 months"
575200|NCT00928057|B3|Baseline|Total|Total of all reporting groups
575201|NCT00928057|B2|Baseline|4 mm / 5 mm PN|This group represents all subjects that were randomized to the study arm comparing the 4 mm and 5 mm pen needles, regardless of whether they completed the study.
575202|NCT00928057|B1|Baseline|4 mm / 8 mm PN|This group represents all subjects that were randomized to the study arm comparing the 4 mm and 8 mm pen needles, regardless of whether they completed the study.
575203|NCT00928057|P2|Participant Flow|4 mm / 5 mm PN|This group represents all subjects that were randomized to compare the 4mm and 5mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment.
575204|NCT00928057|P1|Participant Flow|4 mm / 8 mm PN|This group represents all subjects that were randomized to compare the 4mm and 8mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment.
575205|NCT00928057|O3|Outcome|8 mm PN|Use of 8 mm PN for insulin injections for 3 weeks.
575206|NCT00928057|O2|Outcome|5 mm PN|Use of 5 mm PN for insulin injections for 3 weeks.
575207|NCT00928057|O1|Outcome|4 mm PN|Use of 4 mm PN for insulin injections for 3 weeks.
575208|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
575209|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
575210|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN
575211|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN
575212|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN
575213|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN, either during the first or second 3 weeks of the study.
575214|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN, either during the first or second 3 weeks of the study.
575215|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN, either during the first or second 3 weeks of the study.
575216|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN, either during the first or second 3 weeks of the study.
575217|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN, either during the first or second 3 weeks of the study.
575218|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN, either during the first or second 3 weeks of the study.
575219|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
575220|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
575221|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
575222|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
575223|NCT00928057|E3|Reported Event|4mm PN|All randomized subjects that used the 4mm pen needle.
575224|NCT00928057|E2|Reported Event|5mm PN|All randomized subjects that used the 5 mm pen needle.
575225|NCT00928057|E1|Reported Event|8mm PN|All randomized subjects that used the 8 mm pen needle.
575226|NCT00928070|B3|Baseline|Total|Total of all reporting groups
575614|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575232|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575233|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575234|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575302|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 400mg aqueous dispersion"
575235|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575236|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575237|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575238|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575239|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575240|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575241|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575242|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575243|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575244|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575245|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575246|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575247|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575248|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575249|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575250|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575251|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575252|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575253|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575254|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575255|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575256|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575257|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575258|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575259|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575260|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575261|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575262|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575263|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575264|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575265|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575266|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575267|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575268|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575269|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575270|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575271|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575272|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575273|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575274|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575275|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575276|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575277|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575278|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575279|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575280|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575281|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575282|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575283|NCT00928070|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
575284|NCT00928070|E1|Reported Event|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
575285|NCT00928083|B4|Baseline|Total|Total of all reporting groups
575286|NCT00928083|B3|Baseline|Part C - OZ439 Multiple Rising Dose|Subjects were assigned to individual dose cohorts (200, 400 and 800 mg OZ439) and placebo.
575287|NCT00928083|B2|Baseline|Part B - OZ439 Food Effect|"Subjects were randomized to sequence groups, fasted/fed or fed/fasted while receiving a single dose of 800 mg OZ439."
575288|NCT00928083|B1|Baseline|Part A - OZ439 Single Rising Dose|Included 3 Cohorts, where subjects in cohorts 1 and 2 were randomized to a treatment sequence, receiving doses of OZ439 on four occasions and placebo on one occasion, and subjects in Cohort 3 were administered increasing doses of the oral dispersion.
575289|NCT00928083|P9|Participant Flow|Part C - Placebo|Part C - Placebo
575290|NCT00928083|P8|Participant Flow|Part C - 800mg OZ439 Multiple Dose|OZ439 800mg for 3 consecutive days
575291|NCT00928083|P7|Participant Flow|Part C - 400mg OZ439 Multiple Dose|OZ439 400mg for 3 consecutive days
575292|NCT00928083|P6|Participant Flow|Part C - 200mg OZ439 Multiple Dose|200mg OZ439 for 3 consecutive days
575293|NCT00928083|P5|Participant Flow|Part B - Food Effect - Cohort 2|Food Effect - Cohort 2 800mg OZ439 Fed then Fasted
575294|NCT00928083|P4|Participant Flow|Part B - Food Effect - Cohort 1|Food Effect - Cohort 1 800mg OZ439 Fasted then Fed
575295|NCT00928083|P3|Participant Flow|Part A - OZ439 Single Dose - Cohort 3|Oral Dispersion OZ439 50-1600 mg
575297|NCT00928083|P1|Participant Flow|Part A - OZ439 Single Dose - Cohort 1|OZ439 50 mg then 200 mg, then 800 mg, then 1600 mg, then Placebo
575298|NCT00928083|O3|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 800mg aqueous dispersion"
575299|NCT00928083|O2|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 400mg aqueous dispersion"
575300|NCT00928083|O1|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 200mg aqueous dispersion"
575301|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 800mg aqueous dispersion"
575303|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 200mg aqueous dispersion"
575304|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions
OZ439 800mg aqueous dispersion"
575305|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions
OZ439 800mg aqueous dispersion"
575306|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 1600mg aqueous dispersion"
575307|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)
OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
575308|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 800mg aqueous dispersion"
575309|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)
OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
575310|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)
OZ439 400mg aqueous dispersion"
575311|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)
OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
575312|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)
OZ439 200mg API capsules"
575313|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)
OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
575314|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)
OZ439 50mg API capsules"
575315|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 800mg aqueous dispersion"
575316|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 400mg aqueous dispersion"
575317|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 200mg aqueous dispersion"
575318|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions
OZ439 800mg aqueous dispersion"
575319|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions
OZ439 800mg aqueous dispersion"
575320|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 1600mg aqueous dispersion"
575321|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)
OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
575322|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 800mg aqueous dispersion"
575323|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)
OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
575324|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)
OZ439 400mg aqueous dispersion"
575325|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)
OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
575326|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)
OZ439 200mg API capsules"
575327|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)
OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
575328|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)
OZ439 50mg API capsules"
575329|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 800mg aqueous dispersion"
575330|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 400mg aqueous dispersion"
575331|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 200mg aqueous dispersion"
575332|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions
OZ439 800mg aqueous dispersion"
575333|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions
OZ439 800mg aqueous dispersion"
575334|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 1600mg aqueous dispersion"
575335|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)
OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
575336|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 800mg aqueous dispersion"
575337|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)
OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
575338|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)
OZ439 400mg aqueous dispersion"
575339|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)
OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
575340|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)
OZ439 200mg API capsules"
575511|NCT00928421|P1|Participant Flow|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
575341|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)
OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
575342|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)
OZ439 50mg API capsules"
575343|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 800mg aqueous dispersion"
575344|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 400mg aqueous dispersion"
575345|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 200mg aqueous dispersion"
575346|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions
OZ439 800mg aqueous dispersion"
575347|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions
OZ439 800mg aqueous dispersion"
575348|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 1600mg aqueous dispersion"
575349|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)
OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
575350|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 800mg aqueous dispersion"
575351|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)
OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
575352|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)
OZ439 400mg aqueous dispersion"
575353|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)
OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
575354|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)
OZ439 200mg API capsules"
575355|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)
OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
575356|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)
OZ439 50mg API capsules"
575357|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 800mg aqueous dispersion"
575358|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 400mg aqueous dispersion"
575359|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 200mg aqueous dispersion"
575360|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions
OZ439 800mg aqueous dispersion"
575361|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions
OZ439 800mg aqueous dispersion"
575362|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 1600mg aqueous dispersion"
575363|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)
OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
575364|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 800mg aqueous dispersion"
575365|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)
OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
575366|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)
OZ439 400mg aqueous dispersion"
575367|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)
OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
575368|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)
OZ439 200mg API capsules"
575369|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)
OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
575370|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)
OZ439 50mg API capsules"
575371|NCT00928083|O17|Outcome|Part C - Placebo|"Placebo control for Multiple rising Part C
Placebo"
575372|NCT00928083|O16|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 800mg aqueous dispersion"
575373|NCT00928083|O15|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 400mg aqueous dispersion"
575374|NCT00928083|O14|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 200mg aqueous dispersion"
575375|NCT00928083|O13|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions
OZ439 800mg aqueous dispersion"
575376|NCT00928083|O12|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions
OZ439 800mg aqueous dispersion"
575377|NCT00928083|O11|Outcome|Part A - Placebo|"Placebo control for Single rising Part A
Placebo"
575378|NCT00928083|O10|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 1600mg aqueous dispersion"
575379|NCT00928083|O9|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)
OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
575380|NCT00928083|O8|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 800mg aqueous dispersion"
575381|NCT00928083|O7|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)
OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
575382|NCT00928083|O6|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)
OZ439 400mg aqueous dispersion"
575383|NCT00928083|O5|Outcome|Part A - 400mg Single Dose + Food|"OZ439 Single doses of 400mg (capsules) administered with food.
OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
575384|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)
OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
575385|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)
OZ439 200mg API capsules"
575615|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575386|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)
OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
575387|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)
OZ439 50mg API capsules"
575388|NCT00928083|E17|Reported Event|Part C - Placebo|"Placebo control for Multiple rising Part C
Placebo"
575389|NCT00928083|E16|Reported Event|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 800mg aqueous dispersion"
575390|NCT00928083|E15|Reported Event|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 400mg aqueous dispersion"
575391|NCT00928083|E14|Reported Event|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted
OZ439 200mg aqueous dispersion"
575392|NCT00928083|E13|Reported Event|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions
OZ439 800mg aqueous dispersion"
575393|NCT00928083|E12|Reported Event|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions
OZ439 800mg aqueous dispersion"
575394|NCT00928083|E11|Reported Event|Part A - Placebo|"Placebo control for Single rising Part A
Placebo"
575395|NCT00928083|E10|Reported Event|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 1600mg aqueous dispersion"
575396|NCT00928083|E9|Reported Event|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)
OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
575397|NCT00928083|E8|Reported Event|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)
OZ439 800mg aqueous dispersion"
575398|NCT00928083|E7|Reported Event|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)
OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
575399|NCT00928083|E6|Reported Event|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)
OZ439 400mg aqueous dispersion"
575400|NCT00928083|E5|Reported Event|Part A - 400mg Single Dose + Food|"OZ439 Single doses of 400mg (capsules) administered with food.
OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
575401|NCT00928083|E4|Reported Event|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)
OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
575402|NCT00928083|E3|Reported Event|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)
OZ439 200mg API capsules"
575403|NCT00928083|E2|Reported Event|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)
OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
575404|NCT00928083|E1|Reported Event|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)
OZ439 50mg API capsules"
575405|NCT00928174|B1|Baseline|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
575406|NCT00928174|P1|Participant Flow|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
575407|NCT00928174|O1|Outcome|Single Arm|"fluourine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
IV administration of fluorine-18 fluoromethylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
575408|NCT00928174|E1|Reported Event|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
575409|NCT00928187|B4|Baseline|Total|Total of all reporting groups
575410|NCT00928187|B3|Baseline|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575411|NCT00928187|B2|Baseline|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575412|NCT00928187|B1|Baseline|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575413|NCT00928187|P3|Participant Flow|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575414|NCT00928187|P2|Participant Flow|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575415|NCT00928187|P1|Participant Flow|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575416|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575436|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575417|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575418|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575512|NCT00928421|O1|Outcome|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
575634|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575419|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575420|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575421|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575422|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575423|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575424|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575425|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575426|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575427|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575428|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575429|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575430|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575431|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575432|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575433|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575434|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575435|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575505|NCT00928408|O1|Outcome|Cinacalcet|
575506|NCT00928408|O1|Outcome|Cinacalcet|
575507|NCT00928408|O1|Outcome|Cinacalcet|
575508|NCT00928408|O1|Outcome|Cinacalcet|
575437|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575513|NCT00928421|E1|Reported Event|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
575514|NCT00928434|B4|Baseline|Total|Total of all reporting groups
575635|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575636|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575438|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575439|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575440|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575441|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575442|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575443|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575444|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575445|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575446|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575447|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575448|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575449|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575450|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575451|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575452|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575453|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575454|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575455|NCT00928187|E3|Reported Event|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
575509|NCT00928408|E1|Reported Event|Cinacalcet|
575510|NCT00928421|B1|Baseline|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
575616|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575621|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575622|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575623|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575624|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575456|NCT00928187|E2|Reported Event|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
575457|NCT00928187|E1|Reported Event|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)
emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
575458|NCT00928252|B1|Baseline|Single Arm|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging
IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation."
575459|NCT00928252|P1|Participant Flow|Received 18F-fluorocholine PET/CT|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging
IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation to determine Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV)."
575460|NCT00928252|O1|Outcome|Positive Metabolically Active Tumor Response|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging
IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation. Positive Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV)."
575461|NCT00928252|O1|Outcome|Received 18F-fluorocholine PET/CT|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging
IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation to determine Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV)."
575462|NCT00928252|O1|Outcome|Received 18F-fluorocholine PET/CT|"IV fluorine-18 labeled methylcholine before PET/CT
IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation."
575463|NCT00928252|E1|Reported Event|Single Arm|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging
IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation."
575464|NCT00928304|B1|Baseline|Subjects Enrolled in Study|All Down Syndrome and healthy volunteer subjects
575465|NCT00928304|P2|Participant Flow|Healthy Volunteer Group|70 healthy volunteer subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
575466|NCT00928304|P1|Participant Flow|Down Syndrome Group|39 Down Syndrome subjects received Florbetaben (BAY94-9172) : 300 megabecquerels (MBq) single IV injection of 2 to 10 mL
575467|NCT00928304|O3|Outcome|Healthy Volunteer Group|All healthy volunteers enrolled in the study
575468|NCT00928304|O2|Outcome|Down Syndrome PET-negative (Majority Read)|Down Syndrome subjects negative for cerebral beta-amyloid as determined by majority read
575469|NCT00928304|O1|Outcome|Down Syndrome PET-positive (Majority Read)|Down Syndrome subjects positive for cerebral beta-amyloid as determined by majority read
575470|NCT00928304|O2|Outcome|Healthy Volunteer Group|Healthy volunteers enrolled in the study
575471|NCT00928304|O1|Outcome|Down Syndrome Group|Subjects with Down Syndrome enrolled in the study
575472|NCT00928304|O2|Outcome|Majority Read (DS-Old)|Majority Read results for Down Syndrome subjects with age >46 yrs
575473|NCT00928304|O1|Outcome|Majority Read (DS-Young)|Majority Read results for Down Syndrome subjects with age <= 46 yrs
575474|NCT00928304|O1|Outcome|Majority Read|Majority read of the visual assessment made by 3 independent readers of PET images from all subjects.
575475|NCT00928304|E2|Reported Event|Healthy Volunteer Group|70 healthy volunteer subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
575476|NCT00928304|E1|Reported Event|Down Syndrome Group|39 Down Syndrome subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
575477|NCT00928395|B1|Baseline|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
575478|NCT00928395|P1|Participant Flow|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
575479|NCT00928395|O1|Outcome|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
575480|NCT00928395|E1|Reported Event|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
575481|NCT00928408|B1|Baseline|Cinacalcet|
575482|NCT00928408|P1|Participant Flow|Cinacalcet|
575483|NCT00928408|O1|Outcome|Cinacalcet|
575484|NCT00928408|O1|Outcome|Cinacalcet|
575485|NCT00928408|O1|Outcome|Cinacalcet|
575486|NCT00928408|O1|Outcome|Cinacalcet|
575487|NCT00928408|O1|Outcome|Cinacalcet|
575488|NCT00928408|O1|Outcome|Cinacalcet|
575489|NCT00928408|O1|Outcome|Cinacalcet|
575490|NCT00928408|O1|Outcome|Cinacalcet|
575491|NCT00928408|O1|Outcome|Cinacalcet|
575492|NCT00928408|O1|Outcome|Cinacalcet|
575493|NCT00928408|O1|Outcome|Cinacalcet|
575494|NCT00928408|O1|Outcome|Cinacalcet|
575495|NCT00928408|O1|Outcome|Cinacalcet|
575496|NCT00928408|O1|Outcome|Cinacalcet|
575497|NCT00928408|O1|Outcome|Cinacalcet|
575498|NCT00928408|O1|Outcome|Cinacalcet|
575499|NCT00928408|O1|Outcome|Cinacalcet|
575500|NCT00928408|O1|Outcome|Cinacalcet|
575501|NCT00928408|O1|Outcome|Cinacalcet|
575502|NCT00928408|O1|Outcome|Cinacalcet|
575503|NCT00928408|O1|Outcome|Cinacalcet|
575504|NCT00928408|O1|Outcome|Cinacalcet|
575515|NCT00928434|B3|Baseline|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer’s labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)"
575516|NCT00928434|B2|Baseline|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575517|NCT00928434|B1|Baseline|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575518|NCT00928434|P3|Participant Flow|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575519|NCT00928434|P2|Participant Flow|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575520|NCT00928434|P1|Participant Flow|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575521|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575522|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575523|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575593|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
575617|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575618|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575625|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575626|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575627|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575524|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575525|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575526|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575527|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575528|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575529|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575530|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575531|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575532|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575533|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575534|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575535|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575536|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575537|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575538|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575539|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575540|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575541|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575542|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575543|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575544|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575545|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575546|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575594|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
575547|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575548|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575549|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575550|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575551|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575552|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575553|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575554|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575555|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575556|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575557|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575558|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575595|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
575559|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575560|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575561|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575562|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575563|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575564|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575565|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575566|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575567|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575568|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575569|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
575570|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575596|NCT00928486|E1|Reported Event|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
575571|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575572|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575573|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
575574|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575575|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575576|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575577|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
575578|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575579|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575580|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575581|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575597|NCT00928512|B6|Baseline|Total|Total of all reporting groups
575598|NCT00928512|B5|Baseline|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575599|NCT00928512|B4|Baseline|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575600|NCT00928512|B3|Baseline|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575601|NCT00928512|B2|Baseline|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575602|NCT00928512|B1|Baseline|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575603|NCT00928512|P5|Participant Flow|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575604|NCT00928512|P4|Participant Flow|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575582|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575583|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575584|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575585|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575586|NCT00928434|O2|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
575587|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575588|NCT00928434|E3|Reported Event|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
575589|NCT00928434|E2|Reported Event|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
575590|NCT00928434|E1|Reported Event|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
575591|NCT00928486|B1|Baseline|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
575592|NCT00928486|P1|Participant Flow|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
575605|NCT00928512|P3|Participant Flow|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575606|NCT00928512|P2|Participant Flow|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575607|NCT00928512|P1|Participant Flow|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575637|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575638|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575639|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575640|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575641|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575642|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575643|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575644|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575645|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575646|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575647|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575648|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575649|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575650|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575651|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575652|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575653|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575654|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575655|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575656|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575657|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575658|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575659|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575660|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575661|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575662|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575663|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575664|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575665|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575666|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575667|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575668|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575669|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575670|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575671|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575672|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575673|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575674|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575675|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575676|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575677|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575678|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575679|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575680|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575681|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575682|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575683|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575684|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575685|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575686|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575687|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575688|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575689|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575690|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575691|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575692|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575693|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
575694|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
575695|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
575696|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
575697|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
575698|NCT00928512|E9|Reported Event|AIN457 300mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 300mg
575699|NCT00928512|E8|Reported Event|AIN457 150mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 150mg
575700|NCT00928512|E7|Reported Event|AIN457 75mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 75mg
575701|NCT00928512|E6|Reported Event|AIN457 25mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 25mg
575702|NCT00928512|E5|Reported Event|Placebo|Up to Week 20 - Placebo
575703|NCT00928512|E4|Reported Event|AIN457 300mg|Up to Week 20 - AIN457 300mg
575704|NCT00928512|E3|Reported Event|AIN457 150mg|Up to Week 20 - AIN457 150mg
575705|NCT00928512|E2|Reported Event|AIN457 75mg|Up to Week 20 - AIN457 75mg
575706|NCT00928512|E1|Reported Event|AIN457 25mg|Up to Week 20 - AIN457 25mg
575707|NCT00928642|B1|Baseline|Treatment|Open label, non-randomized, single treatment group.
575708|NCT00928642|P1|Participant Flow|Oral Imatinib Plus Gemcitabine|Open label, non-randomized, single treatment group.
575709|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
575710|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
575711|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
575712|NCT00928642|O1|Outcome|Oral Imatinib Plus IV Gemcitabine|Open label, non-randomized, single treatment group. all subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis that progressed after prior treatment.
575713|NCT00928642|O1|Outcome|Oral Imatinib Puls IV Gemcitabine|Open label, non-randomized, single treatment group.
575714|NCT00928642|O1|Outcome|Oral Imatinib Plus Gemcitabine|"Open label, non-randomized, single treatment group.
All subjects has measurable or evaluabel epithelial ovarian cancer or preitoneal carcinomatosis. all subjects were treated with oral imatinib and IV gemcitabine."
575715|NCT00928642|E1|Reported Event|Treatment|Open label, non-randomized, single treatment group.
575716|NCT00921310|B3|Baseline|Total|Total of all reporting groups
575717|NCT00921310|B2|Baseline|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:
Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575718|NCT00921310|B1|Baseline|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:
Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Participants enrolled in the Phase I portion Dose Level -1 received:
Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575719|NCT00921310|P3|Participant Flow|Phase 2 (Pemetrexed & Temsirolimus)|"Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.
Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575720|NCT00921310|P2|Participant Flow|Phase I Dose Level -1 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575721|NCT00921310|P1|Participant Flow|Phase I Dose Level 1 (Pemetrexed & Temsirolimus)|"Pemetrexed 500mg/m^2 intravenous (IV) on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575722|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575723|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1
Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Dose Level -1
Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575724|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575725|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1
Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Dose Level -1
Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575726|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575727|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1
Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Dose Level -1
Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575728|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575729|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1
Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Dose Level -1
Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575730|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575731|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1
Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Dose Level -1
Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575732|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575733|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1
Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Dose Level -1
Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575734|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575803|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575735|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1
Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Dose Level -1
Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575736|NCT00921310|O3|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.
Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575737|NCT00921310|O2|Outcome|Phase 1 Dose Level -1 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575738|NCT00921310|O1|Outcome|Phase I Dose Level 1 (Premetrexed & Temsirolimus)|"Pemetrexed 500mg/m^2 intravenous (IV) on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575739|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:
Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575740|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:
Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Participants enrolled in the Phase I portion Dose Level -1 received:
Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575741|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:
Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575742|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:
Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Participants enrolled in the Phase I portion Dose Level -1 received:
Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575743|NCT00921310|E2|Reported Event|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
575744|NCT00921310|E1|Reported Event|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1
Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Dose Level -1
Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
575745|NCT00921518|B3|Baseline|Total|Total of all reporting groups
575746|NCT00921518|B2|Baseline|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
575747|NCT00921518|B1|Baseline|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
575748|NCT00921518|P2|Participant Flow|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
575749|NCT00921518|P1|Participant Flow|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
575750|NCT00921518|O2|Outcome|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
575751|NCT00921518|O1|Outcome|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
575752|NCT00921518|E2|Reported Event|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
575753|NCT00921518|E1|Reported Event|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
575754|NCT00921557|B4|Baseline|Total|Total of all reporting groups
575755|NCT00921557|B3|Baseline|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575756|NCT00921557|B2|Baseline|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575757|NCT00921557|B1|Baseline|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575758|NCT00921557|P3|Participant Flow|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575759|NCT00921557|P2|Participant Flow|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575760|NCT00921557|P1|Participant Flow|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575761|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575817|NCT00921687|B3|Baseline|Total|Total of all reporting groups
575762|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575763|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575764|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575765|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575766|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575767|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575768|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575769|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575770|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575771|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575772|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575773|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575774|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575775|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575776|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575777|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575778|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575779|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575780|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575781|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575782|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575783|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575784|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575785|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575786|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575787|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575788|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575789|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575790|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575791|NCT00921557|O3|Outcome|1B: Alendronate/Placebo (96 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
575792|NCT00921557|O2|Outcome|2: Placebo/Alendronate (48 Week Change)|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575793|NCT00921557|O1|Outcome|1B: Alendronate/Placebo (48 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
575794|NCT00921557|O3|Outcome|1B: Alendronate/Placebo (96 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
575795|NCT00921557|O2|Outcome|2: Placebo/Alendronate (48 Week Change)|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575796|NCT00921557|O1|Outcome|1B: Alendronate/Placebo (48 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
575797|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
575798|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
575799|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
575800|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
575801|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575802|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575804|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575805|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575806|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575807|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
575808|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
575809|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
575810|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
575811|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
575812|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
575813|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
575814|NCT00921557|E3|Reported Event|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
575815|NCT00921557|E2|Reported Event|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
575816|NCT00921557|E1|Reported Event|1A: Alendronate/Alendronate|Participants received alendronate for 48 weeks
575818|NCT00921687|B2|Baseline|Intervention Clinic|The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
575819|NCT00921687|B1|Baseline|Control Clinic|Providers in the control group received education only (chronic kidney disease (CKD) lecture and a CKD reference card).
575820|NCT00921687|P2|Participant Flow|Intervention|The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
575821|NCT00921687|P1|Participant Flow|Control|Providers in the control group received education only (CKD lecture and a CKD reference card).
575822|NCT00921687|O2|Outcome|Intervention Clinic|
575823|NCT00921687|O1|Outcome|Control Clinic|
575824|NCT00921687|O2|Outcome|Intervention Clinic|
575825|NCT00921687|O1|Outcome|Control Clinic|
575826|NCT00921687|E2|Reported Event|Intervention Clinic|
575827|NCT00921687|E1|Reported Event|Control Clinic|
575828|NCT00921895|B1|Baseline|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
575829|NCT00921895|P1|Participant Flow|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
575830|NCT00921895|O2|Outcome|RPS Adeno Detector IV (Specificity)|Looking for the number of true negatives as compared to cell culture.
575831|NCT00921895|O1|Outcome|RPS Adeno Detector IV (Sensitivity)|Looking for the number of true positives as compared to cell culture.
575832|NCT00921895|E1|Reported Event|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
575833|NCT00921934|B1|Baseline|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
575834|NCT00921934|P1|Participant Flow|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
575835|NCT00921934|O1|Outcome|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
575836|NCT00921934|E1|Reported Event|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
575837|NCT00921947|B3|Baseline|Total|Total of all reporting groups
575838|NCT00921947|B2|Baseline|VAX102 SC|Given as 2 µg subcutaneous
575839|NCT00921947|B1|Baseline|VAX102 IM|Given as 1 µg intramuscular
575840|NCT00921947|P2|Participant Flow|VAX102 SC|Given as 2 µg subcutaneous
575841|NCT00921947|P1|Participant Flow|VAX102 IM|Given as 1 µg intramuscular
575842|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
575843|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
575844|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
575845|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
575846|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
575847|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
575848|NCT00921947|E2|Reported Event|VAX102 SC|Given as 2 µg subcutaneous
575849|NCT00921947|E1|Reported Event|VAX102 IM|Given as 1 µg intramuscular
575850|NCT00922116|B1|Baseline|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
575851|NCT00922116|P1|Participant Flow|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 micrograms [mcg] (based on previous erythropoiesis stimulating agent therapy) administered via subcutaneous (SC) injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
575852|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
575853|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
575854|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
575855|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
575856|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
575857|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
575858|NCT00922116|E1|Reported Event|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
575859|NCT00922194|B1|Baseline|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
575860|NCT00922194|P1|Participant Flow|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
575861|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
575862|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
575863|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
575864|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
575865|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
575866|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
575867|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
575868|NCT00922194|E1|Reported Event|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
575869|NCT00922207|B4|Baseline|Total|Total of all reporting groups
575870|NCT00922207|B3|Baseline|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575871|NCT00922207|B2|Baseline|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575872|NCT00922207|B1|Baseline|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575873|NCT00922207|P3|Participant Flow|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575874|NCT00922207|P2|Participant Flow|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir (Baraclude) 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575875|NCT00922207|P1|Participant Flow|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir (Hepsera) 10 milligrams (mg) tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peginterferon alfa-2a (peg-IFN-alfa-2a; Pegasys) 180 micrograms (µg) subcutaneous (SC) injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575876|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575877|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575878|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575879|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575880|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575881|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575882|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575883|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575884|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575965|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
575885|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575886|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575887|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575888|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575889|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575890|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575891|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575892|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575893|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575894|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575895|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575896|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575897|NCT00922207|E3|Reported Event|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575898|NCT00922207|E2|Reported Event|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575899|NCT00922207|E1|Reported Event|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
575900|NCT00922233|B1|Baseline|Levonorgestrel|0.75 mg levonorgestrel oral contraceptive pills (levonorgestrel) : oral contraceptive pills
575901|NCT00922233|P1|Participant Flow|Levonorgestrel|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
575902|NCT00922233|O1|Outcome|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
575903|NCT00922233|O1|Outcome|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
575904|NCT00922233|O1|Outcome|Levonorgestrel|0.75 mg levonorgestrel oral contraceptive pills
575905|NCT00922233|E1|Reported Event|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
575966|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
575906|NCT00922272|B1|Baseline|Overall|Constitutes all subjects contained in the Safety Analysis Set defined as all subjects who took at least 1 dose of open-label investigational product and for whom at least 1 follow-up safety assessment was made.
575907|NCT00922272|P2|Participant Flow|Placebo|Subjects received placebo once-daily for 4 weeks during the Double-blind Phase to a stable dose of atypical antipsychotic medication.
575908|NCT00922272|P1|Participant Flow|SPD489|The study consisted of a 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication. They were then randomized into the Double-Blind Phase receiving either their optimal dose of adjunctive SPD489 or placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575909|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575910|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575911|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575912|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575913|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575914|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575915|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575916|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575917|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575918|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575919|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575920|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575921|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575922|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575923|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575924|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575925|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575926|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575927|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575928|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575929|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575930|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575931|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575932|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575933|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575934|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575935|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575936|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575937|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575938|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575939|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575940|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575941|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575942|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575943|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575944|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575945|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575946|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575947|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575948|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575949|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575950|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575951|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575952|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575953|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575954|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575955|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575956|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
575957|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
576226|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
575958|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575959|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
575960|NCT00922272|E3|Reported Event|Placebo (Double-blind Phase)|Subjects receive placebo once-daily
575961|NCT00922272|E2|Reported Event|SPD489 (Double-blind Phase)|Subjects receive either 20, 30, 40, 50, 60 or 70 mg of SPD489 (Lisdexamfetamine dimesylate) once-daily
575962|NCT00922272|E1|Reported Event|SPD489 (Open-label Phase)|Subjects receive either 20, 30, 40, 50, 60 or 70 mg of SPD489 (Lisdexamfetamine dimesylate) once-daily
575963|NCT00922428|B1|Baseline|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
575964|NCT00922428|P1|Participant Flow|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
575967|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
575968|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
575969|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
575970|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
575971|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
575972|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
575973|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
575974|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
575975|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
575976|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
575977|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
575978|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
575979|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
575980|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
575981|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
575982|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
575983|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
575984|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
575985|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
575986|NCT00922428|O1|Outcome|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
575987|NCT00922428|O1|Outcome|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
575988|NCT00922428|O3|Outcome|Observational Group (Visit 3)|VAS of the observational group at visit 3
575989|NCT00922428|O2|Outcome|Observational Group (Visit 2)|VAS of the observational group at visit 2
575990|NCT00922428|O1|Outcome|Observational (Visit 1)|VAS of the observational group at beginning
575991|NCT00922428|E1|Reported Event|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
575992|NCT00922623|B1|Baseline|Belotero®|Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
575993|NCT00922623|P1|Participant Flow|Belotero®|Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
575994|NCT00922623|O2|Outcome|Belotero, Right Nasolabial Fold|Belotero injected into the Right Nasolabial Fold of the Face
575995|NCT00922623|O1|Outcome|Belotero, Left Nasolabial Fold|Belotero injected into the Left Nasolabial Fold of the Face
575996|NCT00922623|E2|Reported Event|Belotero, Right Nasolabial Fold|
575997|NCT00922623|E1|Reported Event|Belotero, Left Nasolabial Fold|
575998|NCT00922636|B6|Baseline|Total|Total of all reporting groups
575999|NCT00922636|B5|Baseline|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576000|NCT00922636|B4|Baseline|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576001|NCT00922636|B3|Baseline|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576002|NCT00922636|B2|Baseline|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576165|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
576003|NCT00922636|B1|Baseline|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576004|NCT00922636|P5|Participant Flow|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576005|NCT00922636|P4|Participant Flow|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576006|NCT00922636|P3|Participant Flow|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576007|NCT00922636|P2|Participant Flow|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576193|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576008|NCT00922636|P1|Participant Flow|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576009|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576010|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576011|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576012|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576013|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576014|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576015|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576016|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576017|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576018|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576019|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576020|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576021|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576022|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576023|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576046|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576024|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576025|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576026|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576027|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576028|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576029|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576030|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576031|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576032|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576033|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576034|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576035|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576036|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576037|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576038|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576039|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576040|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576041|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576042|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576043|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576044|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576045|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576047|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576048|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576049|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576050|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576051|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576052|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576053|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576054|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576055|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576056|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576057|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576058|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576059|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576060|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576061|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576062|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576063|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576064|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576065|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576066|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576067|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576068|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576163|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
576069|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576070|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576071|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576072|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576073|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576074|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576075|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576076|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576077|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576078|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576079|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576080|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576081|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576082|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576083|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576084|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576085|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576086|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576087|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576088|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576089|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576090|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576091|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576092|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576093|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576094|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576095|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576096|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576097|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576098|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576099|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576100|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576101|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576102|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576103|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576104|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576105|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576106|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576107|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576108|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576109|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576110|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576111|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576112|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576224|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
576113|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576114|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576115|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576116|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576117|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576118|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576119|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576120|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576121|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576122|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576123|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576124|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576125|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576126|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576127|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576128|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576129|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576130|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576131|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576132|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576133|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576134|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576164|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
576135|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
576136|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576137|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576138|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576139|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576140|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576141|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576142|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576143|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
576144|NCT00922636|E10|Reported Event|Methylphenidate - Taper Phase|Participants were given the placebo in capsule form QD po for the 2-week taper phase.
576145|NCT00922636|E9|Reported Event|LY2216684 (0.3 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase.
576146|NCT00922636|E8|Reported Event|LY2216684 (0.2 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in taper phase.
576147|NCT00922636|E7|Reported Event|LY2216684 (0.1 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase.
576148|NCT00922636|E6|Reported Event|Placebo - Taper Phase|Methylphenidate blind: Participants were given the placebo in capsule form QD po for the 2-week taper phase.
576149|NCT00922636|E5|Reported Event|Methylphenidate - Treatment Phase|Participants were given 18 mg/day to 54 mg/day of extended-release methylphenidate capsules, based on weight QD po for the 8-week double-blind treatment phase. Participants were also given placebo tablets to maintain LY2216684 blinding.
576150|NCT00922636|E4|Reported Event|LY2216684 (0.3 mg/kg/Day) - Treatment Phase|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576151|NCT00922636|E3|Reported Event|LY2216684 (0.2 mg/kg/Day) - Treatment Phase|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576152|NCT00922636|E2|Reported Event|LY2216684 (0.1 mg/kg/Day) - Treatment Phase|Participants were given 0.1 milligrams per kilogram per day (mg/kg/day) of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
576153|NCT00922636|E1|Reported Event|Placebo - Treatment Phase|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase.
576154|NCT00922701|B1|Baseline|Peritoneal Dialysis Solution|The enrolled patients were using for the long dwell (nocturnal) exchange a glucose-based (2.5% w/v) peritoneal dialysis solution.
576155|NCT00922701|P1|Participant Flow|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
576156|NCT00922701|O1|Outcome|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
576157|NCT00922701|E1|Reported Event|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
576158|NCT00922766|B1|Baseline|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
576159|NCT00922766|P1|Participant Flow|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
576160|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
576161|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
576162|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
576166|NCT00922766|E1|Reported Event|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
576167|NCT00922779|B1|Baseline|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
576168|NCT00922779|P1|Participant Flow|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kilograms (kg) received dose of 400 milligrams (mg) (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with Peginterferon (PEG-INF) Alfa-2a 180 micrograms per milliliter (µg/mL) subcutaneous (SC) injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
576169|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
576170|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
576171|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
576172|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
576173|NCT00922779|E1|Reported Event|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
576174|NCT00922935|B4|Baseline|Total|Total of all reporting groups
576175|NCT00922935|B3|Baseline|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
576176|NCT00922935|B2|Baseline|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
576177|NCT00922935|B1|Baseline|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
576178|NCT00922935|P3|Participant Flow|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
576179|NCT00922935|P2|Participant Flow|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
576180|NCT00922935|P1|Participant Flow|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
576181|NCT00922935|O3|Outcome|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
576182|NCT00922935|O2|Outcome|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
576183|NCT00922935|O1|Outcome|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
576184|NCT00922935|E3|Reported Event|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
576225|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
576185|NCT00922935|E2|Reported Event|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
576186|NCT00922935|E1|Reported Event|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
576187|NCT00922987|B1|Baseline|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576188|NCT00922987|P1|Participant Flow|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576189|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576190|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576191|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576192|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576194|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576195|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576196|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576197|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576198|NCT00922987|E1|Reported Event|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
576199|NCT00928668|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 5-way crossover trial. 31 patients were assigned randomly to one of 5 treatment sequences in which they received each of 5 treatments. The duration of each treatment period was 1 day with a 14 day washout period between treatments.
576200|NCT00928668|P5|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg|Patients were administered matching Placebo in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
576201|NCT00928668|P4|Participant Flow|Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg / Olo 10mcg|Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
576202|NCT00928668|P3|Participant Flow|Olo 2mcg / Placebo / Olo 20mcg / Olo 10mcg / Olo 5mcg|Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
576203|NCT00928668|P2|Participant Flow|Olo 10mcg / Olo 20mcg / Olo 2mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
576204|NCT00928668|P1|Participant Flow|Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
576205|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
576206|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
576207|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
576208|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
576209|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
576210|NCT00928668|O5|Outcome|Olo 20 mcg|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
576211|NCT00928668|O4|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
576212|NCT00928668|O3|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
576213|NCT00928668|O2|Outcome|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
576214|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
576215|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
576216|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
576217|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
576218|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
576219|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
576220|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
576221|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
576222|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
576223|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
576227|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
576228|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
576229|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
576230|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
576231|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
576232|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
576233|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
576234|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
576235|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
576236|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
576237|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
576238|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
576239|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
576240|NCT00928668|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
576241|NCT00928668|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
576242|NCT00928668|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
576243|NCT00928668|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
576244|NCT00928668|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
576245|NCT00928694|B1|Baseline|All Participants|
576246|NCT00928694|P2|Participant Flow|SUPRALIP™ First, Then TRICOR™|UK formulation (SUPRALIP™) 160 mg tablet / U.S. formulation (TRICOR™) 160 mg tablet
576247|NCT00928694|P1|Participant Flow|TRICOR™ First, Then SUPRALIP™|U.S. formulation (TRICOR™) 160 mg tablet/ UK formulation (SUPRALIP™) 160 mg tablet
576248|NCT00928694|O2|Outcome|UK Formulation (SUPRALIP™)|UK Formulation: single oral 160 mg dose of the UK formulation of fenofibrate with food.
576249|NCT00928694|O1|Outcome|U.S. Formulation (TRICOR™)|U.S. Formulation: single oral 160 mg dose of the U.S. formulation of fenofibrate with food.
576250|NCT00928694|O2|Outcome|UK Formulation (SUPRALIP™)|UK Formulation: single oral 160 mg dose of the UK formulation of fenofibrate with food.
576251|NCT00928694|O1|Outcome|U.S. Formulation (TRICOR™)|U.S. Formulation: single oral 160 mg dose of the U.S. formulation of fenofibrate with food.
576252|NCT00928694|E2|Reported Event|Supralip™|UK formulation (SUPRALIP™) 160 mg tablet
576253|NCT00928694|E1|Reported Event|Tricor™|U.S. formulation (TRICOR™) 160 mg tablet
576254|NCT00928720|B4|Baseline|Total|Total of all reporting groups
576255|NCT00928720|B3|Baseline|Usual Care Alone|No intervention; participants will received usual medical care for fibromyalgia
576256|NCT00928720|B2|Baseline|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.
sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
576257|NCT00928720|B1|Baseline|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
576258|NCT00928720|P3|Participant Flow|Usual Care Alone|No intervention; usual medical care for fibromyalgia
576259|NCT00928720|P2|Participant Flow|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.
sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
576260|NCT00928720|P1|Participant Flow|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
576261|NCT00928720|O3|Outcome|Usual Care Alone|No intervention; participants will receive usual medical care for fibromyalgia
576262|NCT00928720|O2|Outcome|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.
sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
576263|NCT00928720|O1|Outcome|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
576264|NCT00928720|E3|Reported Event|Usual Care Alone|No intervention; participants will receive usual medical care for fibromyalgia
576265|NCT00928720|E2|Reported Event|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.
sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
576266|NCT00928720|E1|Reported Event|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
576267|NCT00928746|B1|Baseline|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
576268|NCT00928746|P1|Participant Flow|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
576269|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576270|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576271|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576272|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576273|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576274|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576275|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576276|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576277|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576278|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576279|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576280|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576281|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576282|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576283|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
576284|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg - Oral inhalation) - 180 Actuations group
576285|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
576286|NCT00928746|E1|Reported Event|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
576287|NCT00928772|B4|Baseline|Total|Total of all reporting groups
576288|NCT00928772|B3|Baseline|Placebo|"No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
576289|NCT00928772|B2|Baseline|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
576290|NCT00928772|B1|Baseline|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
576291|NCT00928772|P3|Participant Flow|Placebo|"No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
576292|NCT00928772|P2|Participant Flow|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
576293|NCT00928772|P1|Participant Flow|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
576294|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
576295|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
576296|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
576297|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
576298|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
576299|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
576300|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
576301|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
576302|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
576303|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
576304|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
576463|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576305|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
576306|NCT00928772|E3|Reported Event|Placebo|"No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
576307|NCT00928772|E2|Reported Event|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
576308|NCT00928772|E1|Reported Event|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
576309|NCT00928889|B3|Baseline|Total|Total of all reporting groups
576310|NCT00928889|B2|Baseline|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576311|NCT00928889|B1|Baseline|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576312|NCT00928889|P2|Participant Flow|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576313|NCT00928889|P1|Participant Flow|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576314|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576315|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576316|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576317|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576318|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576319|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576320|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576321|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576322|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576323|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576324|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576325|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576326|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576327|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576328|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576329|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576330|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576331|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576332|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576333|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576334|NCT00928889|E2|Reported Event|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
576335|NCT00928889|E1|Reported Event|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
576336|NCT00928954|B1|Baseline|All Study Participants|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
576337|NCT00928954|P2|Participant Flow|Memantine First, Then Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
576338|NCT00928954|P1|Participant Flow|Gabapentin First and Then Memantine|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
576339|NCT00928954|O2|Outcome|Memantine|"Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
memantine: increasing to 40 mg/day"
576340|NCT00928954|O1|Outcome|Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day)
gabapentin: increasing to 1200 mg/day"
576341|NCT00928954|O2|Outcome|Memantine|"Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
memantine: increasing to 40 mg/day"
576342|NCT00928954|O1|Outcome|Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day)
gabapentin: increasing to 1200 mg/day"
576343|NCT00928954|E2|Reported Event|Memantine|Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
576344|NCT00928954|E1|Reported Event|Gabapentin|Increasing dose to 300 mg four times per day (total of 1200 mg/day)
576345|NCT00929331|B3|Baseline|Total|Total of all reporting groups
576346|NCT00929331|B2|Baseline|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576347|NCT00929331|B1|Baseline|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576348|NCT00929331|P2|Participant Flow|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576349|NCT00929331|P1|Participant Flow|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576350|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576351|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576352|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576353|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576354|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576355|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576356|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576357|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576358|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576359|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576360|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576361|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576362|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576363|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576364|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576365|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576366|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576367|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576368|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576369|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576370|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576371|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576372|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576373|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576374|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576375|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576376|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576377|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576378|NCT00929331|E2|Reported Event|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576379|NCT00929331|E1|Reported Event|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
576380|NCT00929344|B4|Baseline|Total|Total of all reporting groups
576381|NCT00929344|B3|Baseline|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576464|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576382|NCT00929344|B2|Baseline|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576383|NCT00929344|B1|Baseline|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576384|NCT00929344|P3|Participant Flow|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576385|NCT00929344|P2|Participant Flow|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576386|NCT00929344|P1|Participant Flow|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576387|NCT00929344|O3|Outcome|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576610|NCT00929734|P2|Participant Flow|Placebo|Placebo: 1 tablet, once daily in three months
576388|NCT00929344|O2|Outcome|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576389|NCT00929344|O1|Outcome|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576390|NCT00929344|O3|Outcome|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576391|NCT00929344|O2|Outcome|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576392|NCT00929344|O1|Outcome|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576393|NCT00929344|O3|Outcome|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576394|NCT00929344|O2|Outcome|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576395|NCT00929344|O1|Outcome|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576396|NCT00929344|E3|Reported Event|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576397|NCT00929344|E2|Reported Event|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576398|NCT00929344|E1|Reported Event|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
576399|NCT00929357|B3|Baseline|Total|Total of all reporting groups
576400|NCT00929357|B2|Baseline|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
576401|NCT00929357|B1|Baseline|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
576402|NCT00929357|P2|Participant Flow|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
576403|NCT00929357|P1|Participant Flow|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
576404|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
576405|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
576465|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576406|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
576407|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
576408|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
576409|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
576410|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
576411|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
576550|NCT00929708|B2|Baseline|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576551|NCT00929708|B1|Baseline|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576412|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
576413|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
576414|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
576415|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
576416|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
576417|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
576418|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
576419|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
576420|NCT00929357|E2|Reported Event|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
576421|NCT00929357|E1|Reported Event|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
576422|NCT00929383|B1|Baseline|Patients Treated With a Wingspan Stent|Prospective, single arm, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
576423|NCT00929383|P1|Participant Flow|Wingspan|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
576424|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
576425|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
576426|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
576427|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
576428|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
576429|NCT00929383|E1|Reported Event|Wingspan|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
576430|NCT00929474|B3|Baseline|Total|Total of all reporting groups
576466|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576431|NCT00929474|B2|Baseline|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
576432|NCT00929474|B1|Baseline|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
576433|NCT00929474|P2|Participant Flow|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
576552|NCT00929708|P5|Participant Flow|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576434|NCT00929474|P1|Participant Flow|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
576435|NCT00929474|O2|Outcome|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
576436|NCT00929474|O1|Outcome|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
576437|NCT00929474|E2|Reported Event|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
576438|NCT00929474|E1|Reported Event|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
576439|NCT00929526|B3|Baseline|Total|Total of all reporting groups
576440|NCT00929526|B2|Baseline|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576441|NCT00929526|B1|Baseline|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576442|NCT00929526|P2|Participant Flow|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576443|NCT00929526|P1|Participant Flow|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576444|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576445|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576446|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576447|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576448|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576449|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576450|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576451|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576452|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576453|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576454|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576455|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576456|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576457|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576458|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576459|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576460|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576461|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576462|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576467|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576468|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576469|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576470|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576471|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576472|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576473|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576474|NCT00929526|E2|Reported Event|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
576475|NCT00929526|E1|Reported Event|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
576553|NCT00929708|P4|Participant Flow|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576476|NCT00929578|B1|Baseline|All Study Participants - Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
576477|NCT00929578|P1|Participant Flow|All Study Participants|The sterile placebo: Bacteriostatic Sodium Chloride for Injection. Same subject will also receive dose in other arm of fluphenazine. This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
576478|NCT00929578|O3|Outcome|1 Week Post Dose|Participants with fluphenazine serum levels > 0.200ng/ml
576479|NCT00929578|O2|Outcome|2 Hours Post Dose|Number of participants with fluphenazine serum levels > 0.200ng/ml, 2 hours after administration
576480|NCT00929578|O1|Outcome|Baseline|Number of participants with fluphenazine serum levels > 0.200ng/ml at baseline
576481|NCT00929578|O1|Outcome|All Study Participants|Participants who experienced at least one adverse event.
576482|NCT00929578|O2|Outcome|Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
576483|NCT00929578|O1|Outcome|Placebo|The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
576484|NCT00929578|O2|Outcome|Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
576485|NCT00929578|O1|Outcome|Placebo|The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
576486|NCT00929578|E1|Reported Event|All Study Participants|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion. All participants received medication, as the study was a split study, and subjects received placebo on one side and injection of fluphenazine on other side
576487|NCT00929643|B1|Baseline|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
576488|NCT00929643|P1|Participant Flow|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
576489|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
576490|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
576491|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
576492|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
576493|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
576888|NCT00930982|P2|Participant Flow|Placebo|Inhalation of matching placebo twice a day
576494|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
576495|NCT00929643|E1|Reported Event|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
576496|NCT00929656|B3|Baseline|Total|Total of all reporting groups
576497|NCT00929656|B2|Baseline|Unimanual UE Training + Sham rTMS|Participants randomized to the Placebo Arm received sham rTMS to their ipsilesional hemisphere followed by two hours of paretic arm functional task practice administered/supervised by a physical therapist.
576498|NCT00929656|B1|Baseline|Unimanual UE Training + Real rTMS|Participants randomized to the Experimental Arm received real rTMS (1000 pulses) to their ipsilesional hemisphere followed by two hours of paretic arm functional task practice administered/supervised by a physical therapist.
576499|NCT00929656|P2|Participant Flow|Unimanual UE Training + Sham rTMS|"Unimanual Upper Extremity (UE) training + sham repetitive Transcranial Magnetic Stimulation (rTMS)
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576500|NCT00929656|P1|Participant Flow|Unimanual UE Training + Real rTMS|"Unimanual Upper Extremity (UE) training + repetitive Transcranial Magnetic Stimulation (rTMS)
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576501|NCT00929656|O2|Outcome|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576502|NCT00929656|O1|Outcome|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576503|NCT00929656|O2|Outcome|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576504|NCT00929656|O1|Outcome|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576505|NCT00929656|O2|Outcome|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576506|NCT00929656|O1|Outcome|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576507|NCT00929656|O2|Outcome|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576508|NCT00929656|O1|Outcome|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576509|NCT00929656|O2|Outcome|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576510|NCT00929656|O1|Outcome|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
576511|NCT00929656|E2|Reported Event|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE exercise (100 repetitions) for 16 sessions (4 sessions/week for 4 weeks)"
576512|NCT00929656|E1|Reported Event|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE exercise (100 repetitions) for 16 sessions (4 sessions/week for 4 weeks)"
576513|NCT00929695|B3|Baseline|Total|Total of all reporting groups
576514|NCT00929695|B2|Baseline|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576515|NCT00929695|B1|Baseline|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576516|NCT00929695|P2|Participant Flow|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576517|NCT00929695|P1|Participant Flow|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576518|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
576595|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576890|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576519|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576520|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
576521|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576522|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
576554|NCT00929708|P3|Participant Flow|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576523|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576524|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
576525|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576526|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
576527|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576528|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
576529|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576530|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
576531|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576532|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
576533|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576534|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576535|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576536|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
576537|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576538|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576539|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
576540|NCT00929695|O4|Outcome|Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone|Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
576541|NCT00929695|O3|Outcome|Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone|Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
576542|NCT00929695|O2|Outcome|Grade IIa GVHD; 1.0 mg/kg/d Prednisone|Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
576543|NCT00929695|O1|Outcome|Grade IIa GVHD; 0.5 mg/kg/d Prednisone|Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
577371|NCT00932126|O1|Outcome|PF-03758309, 1 mg QD|PF-03758309 1 mg administered orally once daily
576544|NCT00929695|E2|Reported Event|Arm II (Standard-dose)|"Patients receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.
prednisone: immunosuppressive drug
methylprednisolone: immunosuppressive drug
questionnaire administration: Ancillary studies"
576545|NCT00929695|E1|Reported Event|Arm I (Low-dose)|"Patients receive low-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.
prednisone: immunosuppressive drug
methylprednisolone: immunosuppressive drug
questionnaire administration: Ancillary studies"
576546|NCT00929708|B6|Baseline|Total|Total of all reporting groups
576547|NCT00929708|B5|Baseline|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576548|NCT00929708|B4|Baseline|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576549|NCT00929708|B3|Baseline|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576555|NCT00929708|P2|Participant Flow|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576556|NCT00929708|P1|Participant Flow|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576557|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576558|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576559|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576560|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576561|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576562|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576563|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576564|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576565|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576566|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576567|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576568|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576569|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576570|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576571|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576572|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576573|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576574|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576575|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576576|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576577|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576578|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576579|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576580|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576581|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576582|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576583|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576584|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576585|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576586|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576587|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576588|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576589|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576590|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576591|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576592|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576593|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576594|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576596|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576597|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576598|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576599|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576600|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576601|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576602|NCT00929708|E5|Reported Event|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
576603|NCT00929708|E4|Reported Event|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
576604|NCT00929708|E3|Reported Event|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
576605|NCT00929708|E2|Reported Event|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
576606|NCT00929708|E1|Reported Event|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
576607|NCT00929734|B3|Baseline|Total|Total of all reporting groups
576608|NCT00929734|B2|Baseline|Placebo|Placebo tablet
576609|NCT00929734|B1|Baseline|Rosuvastatin|Rosuvastatin 10mg tablet
576611|NCT00929734|P1|Participant Flow|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
576612|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
576613|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
576614|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
576615|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
576616|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
576617|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
576618|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
576619|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
576620|NCT00929734|E2|Reported Event|Placebo|Placebo: 1 tablet, once daily in three months
576621|NCT00929734|E1|Reported Event|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
576622|NCT00929773|B3|Baseline|Total|Total of all reporting groups
576623|NCT00929773|B2|Baseline|Placebo Laser|inactive light
576624|NCT00929773|B1|Baseline|Erchonia Low Level Laser Therapy|Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area .
576625|NCT00929773|P2|Participant Flow|Placebo Laser|inactive light
576626|NCT00929773|P1|Participant Flow|Erchonia PL2000 Laser|Low level laser energy comprised of 1 milliWatt (mW) of near-infrared light (635 nm) to the neck and shoulder area .
576627|NCT00929773|O2|Outcome|Placebo Laser|inactive light
576628|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area.
576629|NCT00929773|O2|Outcome|Placebo Laser|inactive light
576630|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
576631|NCT00929773|O2|Outcome|Placebo Laser|inactive light
576632|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
576633|NCT00929773|O2|Outcome|Placebo Laser|inactive light
576634|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
576635|NCT00929773|O2|Outcome|Placebo Laser|inactive light
576636|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area.
576637|NCT00929773|O2|Outcome|Placebo Laser|inactive light
576638|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
576639|NCT00929773|E2|Reported Event|Placebo Laser|inactive light
576640|NCT00929773|E1|Reported Event|Erchonia Low Level Laser Therapy|Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area .
576641|NCT00929864|B3|Baseline|Total|Total of all reporting groups
576642|NCT00929864|B2|Baseline|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576643|NCT00929864|B1|Baseline|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576644|NCT00929864|P2|Participant Flow|40 mg Adalimumab SC Biweekly|Adalimumab 40 mg, biweekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576705|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576645|NCT00929864|P1|Participant Flow|125 mg Abatacept SC Weekly|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576646|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576647|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576662|NCT00929981|B1|Baseline|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
576663|NCT00929981|P1|Participant Flow|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
576648|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576649|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576650|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576651|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576652|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576653|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576654|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576655|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576656|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576657|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576658|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576706|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
576889|NCT00930982|P1|Participant Flow|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576659|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576660|NCT00929864|E2|Reported Event|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576661|NCT00929864|E1|Reported Event|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
576664|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
576665|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
576666|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
576667|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
576668|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
576669|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
576670|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
576671|NCT00929981|E1|Reported Event|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
576672|NCT00930176|B1|Baseline|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
576673|NCT00930176|P1|Participant Flow|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
576674|NCT00930176|O1|Outcome|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
576675|NCT00930176|O1|Outcome|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
576676|NCT00930176|E1|Reported Event|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
576677|NCT00930293|B3|Baseline|Total|Total of all reporting groups
576678|NCT00930293|B2|Baseline|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.
Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes
Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
576679|NCT00930293|B1|Baseline|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.
Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes
Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
576680|NCT00930293|P2|Participant Flow|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.
Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes
Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
576681|NCT00930293|P1|Participant Flow|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.
Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes
Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
576682|NCT00930293|O2|Outcome|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.
Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes
Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
576707|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
576683|NCT00930293|O1|Outcome|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.
Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes
Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
576684|NCT00930293|O2|Outcome|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.
Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes
Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
576685|NCT00930293|O1|Outcome|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.
Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes
Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
576686|NCT00930293|E2|Reported Event|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.
Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes
Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
576973|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
576687|NCT00930293|E1|Reported Event|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.
Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes
Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
576688|NCT00930553|B1|Baseline|Alemtuzumab|Participants enrolled from any of the previous studies received long-term follow-up in this study. Participants randomized to receive IFNB-1a in any of the previous studies received alemtuzumab 12 mg/day infusion IV, QD for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on MRI), unless they met safety-related retreatment disqualifying criteria.
576689|NCT00930553|P1|Participant Flow|Alemtuzumab|Participants enrolled from any of the prior studies received long-term follow-up in this study. Participants randomized to receive interferon beta-1a (IFNB-1a) in prior studies received alemtuzumab 12 mg/day infusion intravenously (IV) once daily (QD) for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on magnetic resonance imaging [MRI]), unless they met safety-related retreatment disqualifying criteria.
576690|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576691|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576692|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576693|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576694|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
576695|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
576696|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576697|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576698|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576699|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576700|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
576701|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
576702|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576703|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576704|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576820|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks"
576708|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576709|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576710|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576711|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576712|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
576713|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
576714|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
576715|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
576716|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
576717|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
576718|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
576719|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
576720|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
576721|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
576722|NCT00930553|O1|Outcome|Alemtuzumab Retreatment|Participants who received alemtuzumab in CAMMS323 or CAMMS324 who received an additional course of alemtuzumab in CAMMS03409.
576723|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576724|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576725|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576726|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576727|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
576728|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
576729|NCT00930553|O1|Outcome|Alemtuzumab Retreatment|Participants who received alemtuzumab in CAMMS323 or CAMMS324 who received an additional course of alemtuzumab in CAMMS03409.
576730|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576731|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576732|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576733|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576734|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
576735|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
576736|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576737|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576738|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study.
576739|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study.
576740|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576741|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576742|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576743|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576744|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study.
576745|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study.
576746|NCT00930553|O1|Outcome|Alemtuzumab Retreatment|Participants who received alemtuzumab in CAMMS323 (NCT00530348) or CAMMS324 (NCT00548405), received an additional course of alemtuzumab in this study.
576747|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576748|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576749|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
576750|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
576751|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study (CAMMS03409).
576752|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study (CAMMS03409).
576753|NCT00930553|E1|Reported Event|Alemtuzumab|Participants enrolled in any of the previous studies who had received alemtuzumab. Participants enrolled in any of the previous studies who had received IFNB-1a, who received alemtuzumab 12 mg/day infusion in this study.
576754|NCT00930644|B1|Baseline|Teduglutide 0.05 mg/kg/Day|teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
576755|NCT00930644|P1|Participant Flow|Teduglutide 0.05 mg/kg/Day|teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
576756|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
576757|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
576758|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
576759|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
576760|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
576761|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
576762|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
576763|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
576764|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
576765|NCT00930644|E2|Reported Event|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
576766|NCT00930644|E1|Reported Event|NT,PBO/TED|No treatment or placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
576767|NCT00930722|B1|Baseline|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576768|NCT00930722|P1|Participant Flow|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576769|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576770|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576771|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576772|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576773|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576821|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device
FM system: Frequency modulation assistive device"
576774|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576775|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576776|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576777|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576778|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576779|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576780|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576781|NCT00930722|E1|Reported Event|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
576782|NCT00930761|B3|Baseline|Total|Total of all reporting groups
576783|NCT00930761|B2|Baseline|Music Therapy|
576784|NCT00930761|B1|Baseline|Control|
576785|NCT00930761|P2|Participant Flow|Music Therapy|
576786|NCT00930761|P1|Participant Flow|Control|
576787|NCT00930761|O2|Outcome|Music Therapy|
576788|NCT00930761|O1|Outcome|Control|
576789|NCT00930761|O2|Outcome|Music Therapy|
576790|NCT00930761|O1|Outcome|Control|
576791|NCT00930761|O2|Outcome|Music Therapy|
576792|NCT00930761|O1|Outcome|Control|
576793|NCT00930761|O2|Outcome|Music Therapy|
576794|NCT00930761|O1|Outcome|Control|
576795|NCT00930761|E2|Reported Event|Music Therapy|
576796|NCT00930761|E1|Reported Event|Control|
576797|NCT00930774|B5|Baseline|Total|Total of all reporting groups
576798|NCT00930774|B4|Baseline|Standard-of-Care|Standard-of-care informational counseling
576799|NCT00930774|B3|Baseline|FM System + Auditory Training|"Provision of FM assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks"
576800|NCT00930774|B2|Baseline|Auditory Training|"Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks"
576801|NCT00930774|B1|Baseline|FM System|"Provision of FM assistive device
FM system: Frequency modulation assistive device"
576802|NCT00930774|P4|Participant Flow|Standard-of-Care|Standard-of-care informational counseling
576803|NCT00930774|P3|Participant Flow|FM System and Auditory Training|"Provision of frequency modulation (FM) assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks"
576804|NCT00930774|P2|Participant Flow|Auditory Training|"Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks"
576805|NCT00930774|P1|Participant Flow|FM System|"Provision of FM assistive device
FM system: Frequency modulation assistive device"
576806|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
576807|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks"
576808|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks"
576809|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device
FM system: Frequency modulation assistive device"
576810|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
576811|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks"
576812|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks"
576813|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device
FM system: Frequency modulation assistive device"
576814|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
576815|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks"
576816|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks"
576817|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device
FM system: Frequency modulation assistive device"
576818|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
576819|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks"
576822|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
576823|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks"
576824|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks"
576825|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device
FM system: Frequency modulation assistive device"
576826|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
576827|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks"
576828|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks"
576829|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device
FM system: Frequency modulation assistive device"
576830|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
576831|NCT00930774|O3|Outcome|FM Sytem + Auditory Training|"Provision of FM assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks"
576974|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
576832|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks"
576833|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device
FM system: Frequency modulation assistive device"
576834|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
576835|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks"
576836|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks"
576837|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device
FM system: Frequency modulation assistive device"
576838|NCT00930774|E4|Reported Event|Standard-of-care|Standard-of-care informational counseling
576839|NCT00930774|E3|Reported Event|FM System + Auditory Training|"Provision of FM assistive device and auditory training
FM system: Frequency modulation assistive device
Auditory training: Participation in computerized auditory training program for eight weeks"
576840|NCT00930774|E2|Reported Event|Auditory Training|"Provision of auditory training
Auditory training: Participation in computerized auditory training program for eight weeks"
576841|NCT00930774|E1|Reported Event|FM System|"Provision of FM assistive device
FM system: Frequency modulation assistive device"
576842|NCT00930787|B3|Baseline|Total|Total of all reporting groups
576843|NCT00930787|B2|Baseline|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
576844|NCT00930787|B1|Baseline|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
576845|NCT00930787|P2|Participant Flow|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
576846|NCT00930787|P1|Participant Flow|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
576847|NCT00930787|O2|Outcome|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
576848|NCT00930787|O1|Outcome|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
576849|NCT00930787|E2|Reported Event|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
576850|NCT00930787|E1|Reported Event|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
576851|NCT00930813|B3|Baseline|Total|Total of all reporting groups
576852|NCT00930813|B2|Baseline|Standard Uncoated Balloon Angioplasty Catheter|"uncoated angioplasty balloon
Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter"
576853|NCT00930813|B1|Baseline|Lutonix Catheter|"Paclitaxel coated Balloon Catheter
Lutonix Catheter: Paclitaxel Coated Balloon Catheter"
576854|NCT00930813|P2|Participant Flow|Uncoated PTA Balloon Catheter|Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
576855|NCT00930813|P1|Participant Flow|Lutonix DCB Catheter|Lutonix DCB: Paclitaxel Coated Balloon Catheter
576856|NCT00930813|O2|Outcome|Uncoated PTA Balloon Catheter|Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
576857|NCT00930813|O1|Outcome|Lutonix DCB Catheter|Lutonix DCB: Paclitaxel Coated Balloon Catheter
576858|NCT00930813|O2|Outcome|Standard Uncoated PTA Catheter|Standard off-the-shelf uncoated PTA Catheter
576859|NCT00930813|O1|Outcome|Lutonix DCB Catheter|Lutonix Paclitaxel Coated Balloon Catheter
576860|NCT00930813|E2|Reported Event|Standard Uncoated Balloon Angioplasty Catheter|"uncoated angioplasty balloon
Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter"
576861|NCT00930813|E1|Reported Event|Lutonix Catheter|"Paclitaxel coated Balloon Catheter
Lutonix Catheter: Paclitaxel Coated Balloon Catheter"
576862|NCT00930930|B3|Baseline|Total|Total of all reporting groups
576863|NCT00930930|B2|Baseline|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576864|NCT00930930|B1|Baseline|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576887|NCT00930982|B1|Baseline|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576865|NCT00930930|P2|Participant Flow|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576866|NCT00930930|P1|Participant Flow|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576867|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576901|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576868|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576869|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576870|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576871|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576872|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576873|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576874|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576875|NCT00930930|E2|Reported Event|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576876|NCT00930930|E1|Reported Event|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
576877|NCT00930969|B1|Baseline|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
576878|NCT00930969|P1|Participant Flow|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
576879|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
576880|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
576881|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
576882|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
576883|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
576884|NCT00930969|E1|Reported Event|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
576885|NCT00930982|B3|Baseline|Total|Total of all reporting groups
576886|NCT00930982|B2|Baseline|Placebo|Inhalation of matching placebo twice a day
576891|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576892|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576893|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576894|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576895|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576896|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576897|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576898|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576899|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576900|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576902|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576903|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576904|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576905|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576906|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576907|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576908|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576909|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576910|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576911|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576912|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576913|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576914|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576915|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576916|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576917|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576918|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
576919|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576920|NCT00930982|E2|Reported Event|Placebo|Inhalation of matching placebo twice a day
576921|NCT00930982|E1|Reported Event|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
576922|NCT00931164|B1|Baseline|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.
Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.
Sodium Oxybate : dosage is by weight"
576923|NCT00931164|P1|Participant Flow|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.
Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.
Sodium Oxybate : dosage is by weight"
576924|NCT00931164|O1|Outcome|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.
Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.
Sodium Oxybate : dosage is by weight"
576925|NCT00931164|E1|Reported Event|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.
Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.
Sodium Oxybate : dosage is by weight"
576926|NCT00931242|B3|Baseline|Total|Total of all reporting groups
576927|NCT00931242|B2|Baseline|Screen Failures|Subjects that were screened but failed to meet inclusion criteria for the study.
576928|NCT00931242|B1|Baseline|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO (by mouth) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type atopic dermatitis or allergic contact dermatitis.
576929|NCT00931242|P2|Participant Flow|Screen Failures|Patients who were screened but failed to meet inclusion criteria for the study
577018|NCT00931385|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
576930|NCT00931242|P1|Participant Flow|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
576931|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
576932|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
576933|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
576934|NCT00931242|E1|Reported Event|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
576935|NCT00931268|B1|Baseline|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
576936|NCT00931268|P1|Participant Flow|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
576937|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
576938|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
576939|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
576940|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
576941|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
576942|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
576943|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
576944|NCT00931268|E1|Reported Event|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
576945|NCT00931307|B1|Baseline|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
576946|NCT00931307|P1|Participant Flow|Lotrafilcon A|Silicone hydrogel, spherical, experimental soft contact lenses worn on the same basis as habitual contact lenses as prescribed by eye care practitioner
576947|NCT00931307|O1|Outcome|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
576948|NCT00931307|E1|Reported Event|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
576949|NCT00931359|B3|Baseline|Total|Total of all reporting groups
576950|NCT00931359|B2|Baseline|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
576951|NCT00931359|B1|Baseline|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
576952|NCT00931359|P2|Participant Flow|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
576953|NCT00931359|P1|Participant Flow|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
576954|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
576955|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
576956|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
576957|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
576958|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
576959|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
576960|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
576961|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
576962|NCT00931359|E2|Reported Event|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
576963|NCT00931359|E1|Reported Event|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
576964|NCT00931385|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
576965|NCT00931385|P4|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg|Patients were administered matching Placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
577019|NCT00931385|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
577830|NCT00937105|O2|Outcome|Participants With no Microbial Bioburden on Lens Cases|
576966|NCT00931385|P3|Participant Flow|Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, matching Placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
576967|NCT00931385|P2|Participant Flow|Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and matching Placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
576968|NCT00931385|P1|Participant Flow|Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Foradil 12 mcg bid in the second period, matching Placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
576969|NCT00931385|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
576970|NCT00931385|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
576971|NCT00931385|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
576972|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
576975|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
576976|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
576977|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
576978|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
576979|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
576980|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
576981|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
576982|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
576983|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
576984|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
576985|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
576986|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
576987|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
576988|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
576989|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
576990|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
576991|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
576992|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
576993|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
576994|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
576995|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
576996|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
576997|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
576998|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
576999|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
577000|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
577001|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
577002|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
577003|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
577004|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
577005|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
577006|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
577007|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
577008|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
577009|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
577010|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
577011|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
577012|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
577013|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
577014|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
577015|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
577016|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
577017|NCT00931385|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
577020|NCT00931385|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
577021|NCT00931411|B3|Baseline|Total|Total of all reporting groups
577022|NCT00931411|B2|Baseline|Formulation 609209 Then 609580 20|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
577023|NCT00931411|B1|Baseline|Formulation 609580 20 Then 609209|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
577024|NCT00931411|P2|Participant Flow|Formulation 609209 Then 609580 20|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
577025|NCT00931411|P1|Participant Flow|Formulation 609580 20 Then 609209|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
577026|NCT00931411|O1|Outcome|All Study Patients|
577055|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
577027|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
577028|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
577029|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577030|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577031|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
577032|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
577033|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577034|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577035|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577036|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577037|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577038|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577039|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577040|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577041|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577042|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
577043|NCT00931411|E2|Reported Event|Formulation 609209|"Adverse events that were recorded before Day 42 for the group Formulation 609209 then 609580 20 and recorded in the subsequent 2 weeks for the group Formulation 609580 20 then 609209. Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups."
577044|NCT00931411|E1|Reported Event|Formulation 609580 20|"Adverse events that were recorded before Day 42 for the group Formulation 609580 20 then 609209 and recorded in the subsequent 2 weeks for the group Formulation 609209 then 609580 20. Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups."
577045|NCT00931463|B3|Baseline|Total|Total of all reporting groups
577046|NCT00931463|B2|Baseline|Ritonavir-boosted Lopinavir and Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily
577047|NCT00931463|B1|Baseline|Ritonavir-boosted Lopinavir and 2N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
577132|NCT00931723|B1|Baseline|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577048|NCT00931463|P2|Participant Flow|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
577049|NCT00931463|P1|Participant Flow|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
577050|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
577051|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
577052|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
577053|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
577054|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
577056|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
577057|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
577058|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
577059|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
577060|NCT00931463|E2|Reported Event|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
577061|NCT00931463|E1|Reported Event|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
577062|NCT00931489|B6|Baseline|Total|Total of all reporting groups
577063|NCT00931489|B5|Baseline|Wet AMD Patients Chronic Non-responderes|"Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
577064|NCT00931489|B4|Baseline|Dry AMD Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
577065|NCT00931489|B3|Baseline|Wet AMD Patients Acute Non-responders|"Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
577066|NCT00931489|B2|Baseline|Normal Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
577067|NCT00931489|B1|Baseline|Wet AMD Patients Responders|"Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
577068|NCT00931489|P5|Participant Flow|Wet AMD Patients Chronic Non-responderes|"Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
577069|NCT00931489|P4|Participant Flow|Dry AMD Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
577070|NCT00931489|P3|Participant Flow|Wet AMD Patients Acute Non-responders|"Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
577071|NCT00931489|P2|Participant Flow|Normal Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
577072|NCT00931489|P1|Participant Flow|Wet AMD Patients Responders|"Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
577073|NCT00931489|O2|Outcome|"Neovascular Wet AMD Patients - Acute Non-responders"|"Subjects with neovascular (wet) AMD treated with 4 or more monthly injections of anti-VEGF without an adequate response (persistent fluid on OCT) Group 3 - non-responders"
577074|NCT00931489|O1|Outcome|"Neovascular Wet AMD Patients - Responders"|"Subjects with neovascular (wet) Age-related Macular Degeneration who respond to ranibizumab after 4 consecutive intraocular injections Group 1"
577075|NCT00931489|O2|Outcome|"Neovascular Wet AMD Patients - Acute Non-responders"|"Subjects with neovascular (wet) AMD treated with 4 or more monthly injections of anti-VEGF without an adequate response (persistent fluid on OCT) Group 3 - non-responders"
577076|NCT00931489|O1|Outcome|"Neovascular Wet AMD Patients - Responders"|"Subjects with neovascular (wet) Age-related Macular Degeneration who respond to ranibizumab after 4 consecutive intraocular injections Group 1"
577077|NCT00931489|O2|Outcome|Population Normals|Normals are subjects that do not have Age-related Macular Degeneration. Group 2
577078|NCT00931489|O1|Outcome|"Neovascular Wet Age-related Macular Degeneration Patients"|"Subjects with active neovascular (wet) AMD. This includes the subjects that responded to treatment (Ranibizumab 0.5mg intravitreal injections at four week intervals) Group 1, and chronic non-responders - those subjects who received four or more anti-VEGF intravitreal injections with persistent fluid on OCT, Group 3.
At baseline, 40 subjects were enrolled into Group 1 Following 4 months of treatment, 3 subjects were moved to Group 3."
577079|NCT00931489|E5|Reported Event|Wet AMD Patients Chronic Non-responderes|"Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
577080|NCT00931489|E4|Reported Event|Dry AMD Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
577081|NCT00931489|E3|Reported Event|Wet AMD Patients Acute Non-responders|"Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
577082|NCT00931489|E2|Reported Event|Normal Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
577083|NCT00931489|E1|Reported Event|Wet AMD Patients Responders|"Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
577084|NCT00931515|B3|Baseline|Total|Total of all reporting groups
577085|NCT00931515|B2|Baseline|ProDisc|The ProDisc® total disc replacement system.
577086|NCT00931515|B1|Baseline|NuBac|The NUBAC® disc arthroplasty system.
577087|NCT00931515|P2|Participant Flow|ProDisc|The ProDisc® total disc replacement system.
577088|NCT00931515|P1|Participant Flow|NuBac|The NUBAC® disc arthroplasty system.
577089|NCT00931515|O2|Outcome|ProDisc|The ProDisc® device total disc replacement system.
577090|NCT00931515|O1|Outcome|NuBac|The NUBAC® disc arthroplasty system.
577091|NCT00931515|E2|Reported Event|ProDisc|The ProDisc® device total disc replacement system.
577092|NCT00931515|E1|Reported Event|NuBac|The NUBAC® disc arthroplasty system.
577093|NCT00931528|B3|Baseline|Total|Total of all reporting groups
577094|NCT00931528|B2|Baseline|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
577095|NCT00931528|B1|Baseline|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
577096|NCT00931528|P2|Participant Flow|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
577097|NCT00931528|P1|Participant Flow|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
577098|NCT00931528|O2|Outcome|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
577099|NCT00931528|O1|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
577100|NCT00931528|E2|Reported Event|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
577101|NCT00931528|E1|Reported Event|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
577102|NCT00931632|B3|Baseline|Total|Total of all reporting groups
577103|NCT00931632|B2|Baseline|Placebo|"Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
577104|NCT00931632|B1|Baseline|Inhaled Nitric Oxide|"Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
577105|NCT00931632|P2|Participant Flow|Placebo|"Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
577106|NCT00931632|P1|Participant Flow|Inhaled Nitric Oxide|"Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
577107|NCT00931632|O2|Outcome|Placebo|"Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
577108|NCT00931632|O1|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
577109|NCT00931632|E2|Reported Event|Placebo|"Nitrogen Placebo
Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
577110|NCT00931632|E1|Reported Event|Inhaled Nitric Oxide|"Inhaled Nitric Oxide
Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
577111|NCT00931710|B3|Baseline|Total|Total of all reporting groups
577133|NCT00931723|P2|Participant Flow|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577134|NCT00931723|P1|Participant Flow|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577135|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577112|NCT00931710|B2|Baseline|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
577113|NCT00931710|B1|Baseline|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
577114|NCT00931710|P2|Participant Flow|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
577115|NCT00931710|P1|Participant Flow|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
577151|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577116|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
577117|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
577118|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
577119|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
577120|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
577121|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
577122|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
577123|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
577124|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
577125|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
577126|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
577127|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
577128|NCT00931710|E2|Reported Event|Losartan / HCTZ|Losartan / HCTZ
577129|NCT00931710|E1|Reported Event|Valsartan / Amlodipine / HCTZ|Valsartan / amlodipine / HCTZ
577130|NCT00931723|B3|Baseline|Total|Total of all reporting groups
577131|NCT00931723|B2|Baseline|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577136|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577137|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577138|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577139|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577140|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577141|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577142|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577143|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577144|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577145|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577146|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577147|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577148|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577149|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577150|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577152|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577153|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577154|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577155|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577156|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577157|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577158|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577159|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577160|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577161|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577162|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577163|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577164|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577165|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577166|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577167|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577168|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577169|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577170|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577171|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577172|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577173|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577174|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577175|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577176|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577177|NCT00931723|E2|Reported Event|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
577178|NCT00931723|E1|Reported Event|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
577179|NCT00931801|B4|Baseline|Total|Total of all reporting groups
577180|NCT00931801|B3|Baseline|Intervention Arm No.2|atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
577181|NCT00931801|B2|Baseline|Intervention Arm No.1|atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
577182|NCT00931801|B1|Baseline|Control Arm|atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
577183|NCT00931801|P3|Participant Flow|Intervention Arm No.2|atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
577184|NCT00931801|P2|Participant Flow|Intervention Arm No.1|atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
577185|NCT00931801|P1|Participant Flow|Control Arm|atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
577186|NCT00931801|O4|Outcome|Total|All study arms combined
577187|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
577188|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
577189|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
577190|NCT00931801|O4|Outcome|Total|All study arms combined
577191|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
577192|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
577193|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
577195|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
577196|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
577197|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
577198|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
577199|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/ritonavir 300/100mg once daily plus raltegravir 400mg twice daily
577200|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/ritonavir 300/100mg once daily plus tenofovir and emtricitabine
577201|NCT00931801|E4|Reported Event|Total|All study arms combined
577202|NCT00931801|E3|Reported Event|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
577203|NCT00931801|E2|Reported Event|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
577204|NCT00931801|E1|Reported Event|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
577205|NCT00925990|B3|Baseline|Total|Total of all reporting groups
577206|NCT00925990|B2|Baseline|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
577380|NCT00932152|B3|Baseline|Total|Total of all reporting groups
577207|NCT00925990|B1|Baseline|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
577208|NCT00925990|P2|Participant Flow|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
577209|NCT00925990|P1|Participant Flow|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
577210|NCT00925990|O2|Outcome|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
577211|NCT00925990|O1|Outcome|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
577212|NCT00925990|O2|Outcome|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
577213|NCT00925990|O1|Outcome|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
577214|NCT00925990|E2|Reported Event|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
577215|NCT00925990|E1|Reported Event|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
577216|NCT00926029|B4|Baseline|Total|Total of all reporting groups
577217|NCT00926029|B3|Baseline|Experimental|triclosan/fluoride/zinc toothpaste
577218|NCT00926029|B2|Baseline|Positive Control|triclosan/fluoride toothpaste
577219|NCT00926029|B1|Baseline|Placebo Control|fluoride toothpaste
577220|NCT00926029|P3|Participant Flow|Experimental|triclosan/fluoride/metal salt toothpaste
577221|NCT00926029|P2|Participant Flow|Positive Control|triclosan/fluoride toothpaste
577222|NCT00926029|P1|Participant Flow|Placebo Control|fluoride toothpaste (Winterfresh Gel)
577223|NCT00926029|O3|Outcome|Experimental|triclosan/fluoride/zinc toothpaste
577224|NCT00926029|O2|Outcome|Positive Control|triclosan/fluoride toothpaste
577225|NCT00926029|O1|Outcome|Placebo Control|fluoride toothpaste
577226|NCT00926029|O3|Outcome|Experimental|triclosan/fluoride/metal salt toothpaste
577227|NCT00926029|O2|Outcome|Positive Control|triclosan/fluoride toothpaste
577228|NCT00926029|O1|Outcome|Placebo Control|fluoride toothpaste (Winterfresh Gel)
577229|NCT00926029|E3|Reported Event|Experimental|triclosan/fluoride/metal salt toothpaste
577230|NCT00926029|E2|Reported Event|Positive Control|triclosan/fluoride toothpaste
577231|NCT00926029|E1|Reported Event|Placebo Control|fluoride toothpaste (Winterfresh Gel)
577232|NCT00931879|B3|Baseline|Total|Total of all reporting groups
577233|NCT00931879|B2|Baseline|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577372|NCT00932126|E8|Reported Event|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
577373|NCT00932126|E7|Reported Event|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
577234|NCT00931879|B1|Baseline|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577235|NCT00931879|P2|Participant Flow|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577236|NCT00931879|P1|Participant Flow|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577237|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577238|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577239|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577240|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577241|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577242|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577243|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577244|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577245|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577259|NCT00931918|B1|Baseline|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577246|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577247|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577248|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577381|NCT00932152|B2|Baseline|Fulvestrant, Anastrozole and Bevacizumab|
577249|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577250|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577251|NCT00931879|O2|Outcome|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577252|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577253|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577254|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577255|NCT00931879|E2|Reported Event|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
577256|NCT00931879|E1|Reported Event|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
577257|NCT00931918|B3|Baseline|Total|Total of all reporting groups
577258|NCT00931918|B2|Baseline|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577305|NCT00932035|B3|Baseline|Total|Total of all reporting groups
577374|NCT00932126|E6|Reported Event|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
577375|NCT00932126|E5|Reported Event|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
577260|NCT00931918|P2|Participant Flow|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577261|NCT00931918|P1|Participant Flow|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577262|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577382|NCT00932152|B1|Baseline|Fulvestrant and Anastrozole Only|
577383|NCT00932152|P2|Participant Flow|Fulvestrant, Anastrozole and Bevacizumab|
577384|NCT00932152|P1|Participant Flow|Fulvestrant and Anastrozole Only|
577263|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577264|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577265|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577266|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577267|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577268|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577269|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577270|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577271|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577272|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577273|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577274|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577365|NCT00932126|O7|Outcome|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
577366|NCT00932126|O6|Outcome|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
577275|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577276|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577277|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577385|NCT00932152|O1|Outcome|All Participants (Overall Study)|
577278|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577279|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577280|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577281|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577282|NCT00931918|E2|Reported Event|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577283|NCT00931918|E1|Reported Event|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
577284|NCT00931996|B1|Baseline|Antipsychotic|Antipsychotic treatment
577285|NCT00931996|P1|Participant Flow|Antipsychotic|Antipsychotic treatment
577286|NCT00931996|O1|Outcome|Antipsychotic|Antipsychotic treatment
577287|NCT00931996|E1|Reported Event|Antipsychotic|Antipsychotic treatment
577288|NCT00932022|B3|Baseline|Total|Total of all reporting groups
577289|NCT00932022|B2|Baseline|Placebo|Placebo capsule taken orally once daily for 14 weeks.
577290|NCT00932022|B1|Baseline|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
577291|NCT00932022|P2|Participant Flow|Placebo|Placebo capsule taken orally once daily for 14 weeks.
577292|NCT00932022|P1|Participant Flow|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
577293|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
577294|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
577295|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
577296|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
577297|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
577298|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
577299|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
577300|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
577301|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
577302|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
577303|NCT00932022|E2|Reported Event|Placebo|Placebo capsule taken orally once daily for 14 weeks.
577304|NCT00932022|E1|Reported Event|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
577306|NCT00932035|B2|Baseline|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
isosulfan blue based lymphatic mapping
axillary lymph node dissection: Undergo standard axillary lymph node dissection
quality-of-life assessment: Ancillary studies
Questionnaire administration: Ancillary studies"
577307|NCT00932035|B1|Baseline|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection
isosulfan blue based lymphatic mapping
quality-of-life assessment: Ancillary studies"
577308|NCT00932035|P2|Participant Flow|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
isosulfan blue based lymphatic mapping
axillary lymph node dissection: Undergo standard axillary lymph node dissection
quality-of-life assessment: Ancillary studies
Questionnaire administration: Ancillary studies"
577386|NCT00932152|E1|Reported Event|All Participants (Overall Study)|
577387|NCT00932165|B1|Baseline|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
577309|NCT00932035|P1|Participant Flow|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection
isosulfan blue based lymphatic mapping
quality-of-life assessment: Ancillary studies"
577310|NCT00932035|O2|Outcome|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
isosulfan blue based lymphatic mapping
axillary lymph node dissection: Undergo standard axillary lymph node dissection
quality-of-life assessment: Ancillary studies
Questionnaire administration: Ancillary studies"
577311|NCT00932035|O1|Outcome|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection
isosulfan blue based lymphatic mapping
quality-of-life assessment: Ancillary studies"
577312|NCT00932035|O2|Outcome|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
isosulfan blue based lymphatic mapping
axillary lymph node dissection: Undergo standard axillary lymph node dissection
quality-of-life assessment: Ancillary studies
Questionnaire administration: Ancillary studies"
577313|NCT00932035|O1|Outcome|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection
isosulfan blue based lymphatic mapping
quality-of-life assessment: Ancillary studies"
577314|NCT00932035|O2|Outcome|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
isosulfan blue based lymphatic mapping
axillary lymph node dissection: Undergo standard axillary lymph node dissection
quality-of-life assessment: Ancillary studies
Questionnaire administration: Ancillary studies"
577315|NCT00932035|O1|Outcome|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection
isosulfan blue based lymphatic mapping
quality-of-life assessment: Ancillary studies"
577316|NCT00932035|E2|Reported Event|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
isosulfan blue based lymphatic mapping
axillary lymph node dissection: Undergo standard axillary lymph node dissection
quality-of-life assessment: Ancillary studies
Questionnaire administration: Ancillary studies"
577317|NCT00932035|E1|Reported Event|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection
isosulfan blue based lymphatic mapping
quality-of-life assessment: Ancillary studies
Questionnaire administration: Ancillary studies"
577318|NCT00932113|B3|Baseline|Total|Total of all reporting groups
577319|NCT00932113|B2|Baseline|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
577320|NCT00932113|B1|Baseline|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
577321|NCT00932113|P2|Participant Flow|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
577367|NCT00932126|O5|Outcome|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
577368|NCT00932126|O4|Outcome|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
577369|NCT00932126|O3|Outcome|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
577322|NCT00932113|P1|Participant Flow|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
577388|NCT00932165|P1|Participant Flow|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
577389|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
577390|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
577391|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
577392|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
577680|NCT00936377|O3|Outcome|Placebo|"Normal saline
Placebo: Normal saline for five days."
577323|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
577324|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
577325|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
577326|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
577327|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
577328|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
577329|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
577330|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
577331|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
577370|NCT00932126|O2|Outcome|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
577332|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
577495|NCT00936065|B4|Baseline|Total|Total of all reporting groups
577333|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
577334|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
577335|NCT00932113|E2|Reported Event|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
577336|NCT00932113|E1|Reported Event|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).
Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
577337|NCT00932126|B1|Baseline|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID and 60 mg BID
577338|NCT00932126|P8|Participant Flow|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice dailly
577339|NCT00932126|P7|Participant Flow|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
577340|NCT00932126|P6|Participant Flow|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
577341|NCT00932126|P5|Participant Flow|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
577342|NCT00932126|P4|Participant Flow|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
577343|NCT00932126|P3|Participant Flow|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
577344|NCT00932126|P2|Participant Flow|PF-03758309, 1 mg Twice Daily (BID)|PF-03758309 1 mg administered orally twice daily
577345|NCT00932126|P1|Participant Flow|PF-03758309, 1 Milligram (mg) Once Daily (QD)|PF-03758309 1 mg administered orally once daily
577346|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
577347|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
577348|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
577349|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
577350|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
577351|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
577352|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
577353|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
577354|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
577355|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
577356|NCT00932126|O8|Outcome|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
577357|NCT00932126|O7|Outcome|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
577358|NCT00932126|O6|Outcome|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
577359|NCT00932126|O5|Outcome|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
577360|NCT00932126|O4|Outcome|PF-03758309, 10 mg BID|PF-03758309, 10 mg BID PF-03758309 10 mg administered orally twice daily
577361|NCT00932126|O3|Outcome|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
577362|NCT00932126|O2|Outcome|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
577363|NCT00932126|O1|Outcome|PF-03758309, 1 mg QD|PF-03758309 1 mg administered orally once daily
577364|NCT00932126|O8|Outcome|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
577376|NCT00932126|E4|Reported Event|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
577377|NCT00932126|E3|Reported Event|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
577378|NCT00932126|E2|Reported Event|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
577379|NCT00932126|E1|Reported Event|PF-03758309, 1 mg QD|PF-03758309, 1 mg administered orally once daily
577393|NCT00932165|O1|Outcome|Exemestane|All the patients whom an investigator prescribes the first Exemestane(Aromasin) should be registered.
577394|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
577395|NCT00932165|O1|Outcome|Exemestane|All the patients whom an investigator prescribes the first Exemestane(Aromasin) should be registered.
577396|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
577397|NCT00932165|E1|Reported Event|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
577398|NCT00935649|B1|Baseline|Randomized Great Toe|Subjects with both great toes infected. Right/left randomized to treatment / no treatment
577399|NCT00935649|P1|Participant Flow|Randomized Great Toe|Subjects with both great toes infected. Right/left randomized to treatment / no treatment
577400|NCT00935649|O2|Outcome|Untreated Great Toe|untreated control great toe
577401|NCT00935649|O1|Outcome|Treated Great Toe|Laser treatment of great toe
577402|NCT00935649|O2|Outcome|Untreated Great Toe|untreated control great toe
577403|NCT00935649|O1|Outcome|Treated Great Toe|Laser treatment of great toe
577404|NCT00935649|E2|Reported Event|Untreated Great Toe|untreated control great toe
577405|NCT00935649|E1|Reported Event|Treated Great Toe|Laser treatment of great toe
577406|NCT00935701|B1|Baseline|Acupuncture and Acupressure|In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
577407|NCT00935701|P1|Participant Flow|Acupuncture and Acupressure|In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
577408|NCT00935701|O1|Outcome|Primary Group|
577409|NCT00935701|O1|Outcome|Primary Group|
577410|NCT00935701|O1|Outcome|Primary Group|
577411|NCT00935701|O1|Outcome|Primary Group|Phase 1
577412|NCT00935701|E1|Reported Event|Primary Group|
577413|NCT00935766|B3|Baseline|Total|Total of all reporting groups
577414|NCT00935766|B2|Baseline|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
577415|NCT00935766|B1|Baseline|Placebo|Placebo (Four 1-gram capsules daily)
577416|NCT00935766|P2|Participant Flow|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
577417|NCT00935766|P1|Participant Flow|Placebo|Placebo (Four 1-gram capsules daily)
577418|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
577419|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
577420|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
577421|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
577422|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
577423|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
577424|NCT00935766|E2|Reported Event|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
577425|NCT00935766|E1|Reported Event|Placebo|Placebo (Four 1-gram capsules daily)
577426|NCT00935792|B4|Baseline|Total|Total of all reporting groups
577427|NCT00935792|B3|Baseline|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577428|NCT00935792|B2|Baseline|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577429|NCT00935792|B1|Baseline|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577430|NCT00935792|P3|Participant Flow|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577431|NCT00935792|P2|Participant Flow|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577432|NCT00935792|P1|Participant Flow|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577433|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577434|NCT00935792|O1|Outcome|All Evaluable Patients|Patients are only evaluable for duration of response when they have already been noted as a complete response or partial response.
577435|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577436|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577437|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577438|NCT00935792|O2|Outcome|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577439|NCT00935792|O1|Outcome|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577440|NCT00935792|O3|Outcome|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577441|NCT00935792|O2|Outcome|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577442|NCT00935792|O1|Outcome|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577443|NCT00935792|E3|Reported Event|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577444|NCT00935792|E2|Reported Event|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577445|NCT00935792|E1|Reported Event|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
577446|NCT00935818|B3|Baseline|Total|Total of all reporting groups
577447|NCT00935818|B2|Baseline|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
577448|NCT00935818|B1|Baseline|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
577449|NCT00935818|P2|Participant Flow|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
577450|NCT00935818|P1|Participant Flow|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
577451|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
577452|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
577453|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
577454|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
577455|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
577535|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577536|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577456|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
577457|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
577458|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
577459|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
577496|NCT00936065|B3|Baseline|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577460|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
577461|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
577462|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
577463|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
577464|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
577465|NCT00935818|E2|Reported Event|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
577466|NCT00935818|E1|Reported Event|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
577467|NCT00935857|B3|Baseline|Total|Total of all reporting groups
577468|NCT00935857|B2|Baseline|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
577469|NCT00935857|B1|Baseline|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
577470|NCT00935857|P2|Participant Flow|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
577471|NCT00935857|P1|Participant Flow|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
577472|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
577473|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
577474|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
577475|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
577476|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
577477|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
577478|NCT00935857|E2|Reported Event|Single Balloon Colonoscopy|Patients who are randomized to received single balloon colonoscopy as initial treatment.
577479|NCT00935857|E1|Reported Event|Standard Colonoscopy|Patients who are randomized to received standard colonoscopy as initial treatment.
577480|NCT00935883|B3|Baseline|Total|Total of all reporting groups
577481|NCT00935883|B2|Baseline|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab
Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577712|NCT00936481|O2|Outcome|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
577482|NCT00935883|B1|Baseline|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator
Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577483|NCT00935883|P2|Participant Flow|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab
Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577497|NCT00936065|B2|Baseline|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577498|NCT00936065|B1|Baseline|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577499|NCT00936065|P3|Participant Flow|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577484|NCT00935883|P1|Participant Flow|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator
Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577485|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab
Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577486|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator
Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577487|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab
Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577488|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator
Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577489|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab
Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577490|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator
Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577491|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab
Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577492|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator
Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577537|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577538|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577539|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577713|NCT00936481|O1|Outcome|Healthy Controls|18 years or older with body mass index between 25-45
577493|NCT00935883|E2|Reported Event|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab
Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577494|NCT00935883|E1|Reported Event|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator
Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).
Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
577500|NCT00936065|P2|Participant Flow|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577501|NCT00936065|P1|Participant Flow|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577502|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577503|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577504|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577505|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577506|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577507|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577508|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577509|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577510|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577511|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577512|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577513|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577514|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577515|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577516|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577517|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577518|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577519|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577520|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577521|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577522|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577523|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577524|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577525|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577526|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577527|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577528|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577529|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577530|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577531|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577532|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577533|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577534|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577540|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577541|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577542|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577543|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577544|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577545|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577546|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577547|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577548|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577549|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577550|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577551|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
578411|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
577552|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577553|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577554|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577555|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577556|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577557|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577558|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577559|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577560|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577561|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577562|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577563|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577564|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577565|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577566|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577567|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577568|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577569|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577570|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577571|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577572|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577573|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577574|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577575|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577576|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577577|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577578|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577579|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577580|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577581|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577582|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577583|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577584|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577585|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577586|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577587|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577588|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577589|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577590|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577591|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577592|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577593|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577594|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577595|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577596|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577597|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577598|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577599|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577600|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577601|NCT00936065|E3|Reported Event|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
577602|NCT00936065|E2|Reported Event|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
577603|NCT00936065|E1|Reported Event|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
577604|NCT00936117|B1|Baseline|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
577605|NCT00936117|P1|Participant Flow|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
577606|NCT00936117|O2|Outcome|Posaconazole (Males)|Posaconazole 200 mg (liquid) by mouth 3 times per day.
577607|NCT00936117|O1|Outcome|Posaconazole (Females)|Posaconazole 200 mg (liquid) by mouth 3 times per day.
577608|NCT00936117|E1|Reported Event|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
577609|NCT00936208|B3|Baseline|Total|Total of all reporting groups
577610|NCT00936208|B2|Baseline|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
577611|NCT00936208|B1|Baseline|Micardis 80mg|One tablet of Micardis 80mg per day
577612|NCT00936208|P2|Participant Flow|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
577613|NCT00936208|P1|Participant Flow|Micardis 80mg|One tablet of Micardis 80mg per day
577614|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
577615|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
577616|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
577617|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
577618|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
577619|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
577620|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
577621|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
577622|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
577623|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
577624|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
577625|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
577626|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
577627|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
577628|NCT00936208|E2|Reported Event|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
577629|NCT00936208|E1|Reported Event|Micardis 80mg|One tablet of Micardis 80mg per day
577630|NCT00936221|B3|Baseline|Total|Total of all reporting groups
577631|NCT00936221|B2|Baseline|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
577632|NCT00936221|B1|Baseline|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
577633|NCT00936221|P2|Participant Flow|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
577634|NCT00936221|P1|Participant Flow|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
577635|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
577636|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
577637|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
577638|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
577639|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
577640|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
577641|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
577642|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
577643|NCT00936221|E2|Reported Event|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
577644|NCT00936221|E1|Reported Event|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
577645|NCT00936351|B3|Baseline|Total|Total of all reporting groups
577646|NCT00936351|B2|Baseline|Arm 2|"Support Group
Support Group (control): A support group during which participants can discuss with each other any issues, problems, or successes at work will be conducted as the control portion."
577647|NCT00936351|B1|Baseline|Arm 1|"Mindfulness Meditation
Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention has been adapted from mindfulness based stress reduction treatment."
577648|NCT00936351|P2|Participant Flow|Arm 2|"Support Group
The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
577649|NCT00936351|P1|Participant Flow|Arm 1|"Mindfulness Meditation
Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
577650|NCT00936351|O2|Outcome|Arm 2|"Support Group
The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
577679|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577651|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation
Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
577652|NCT00936351|O2|Outcome|Arm 2|"Support Group
The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
577653|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation
Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
577654|NCT00936351|O2|Outcome|Arm 2|"Support Group
The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
577655|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation
Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
577656|NCT00936351|E2|Reported Event|Arm 2|"Support Group
The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
577657|NCT00936351|E1|Reported Event|Arm 1|"Mindfulness Meditation
Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
577658|NCT00936377|B4|Baseline|Total|Total of all reporting groups
577659|NCT00936377|B3|Baseline|Placebo|"Normal saline
Placebo: Normal saline for five days."
577660|NCT00936377|B2|Baseline|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577661|NCT00936377|B1|Baseline|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577662|NCT00936377|P3|Participant Flow|Placebo|"Normal saline
Placebo: Normal saline for five days."
577663|NCT00936377|P2|Participant Flow|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577664|NCT00936377|P1|Participant Flow|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577665|NCT00936377|O3|Outcome|Placebo|"Normal saline
Placebo: Normal saline for five days."
577666|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577667|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577668|NCT00936377|O3|Outcome|Placebo|"Normal saline
Placebo: Normal saline for five days."
577669|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577670|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577671|NCT00936377|O3|Outcome|Placebo|"Normal saline
Placebo: Normal saline for five days."
577711|NCT00936481|P1|Participant Flow|Healthy Controls|18 years or older with body mass index between 25-45
577831|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lens Cases|
577672|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577673|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577674|NCT00936377|O3|Outcome|Placebo|"Normal saline
Placebo: Normal saline for five days."
577675|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577676|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577677|NCT00936377|O3|Outcome|Placebo|"Normal saline
Placebo: Normal saline for five days."
577678|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577681|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577682|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577683|NCT00936377|O3|Outcome|Placebo|"Normal saline
Placebo: Normal saline for five days."
577684|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577685|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577686|NCT00936377|O3|Outcome|Placebo|"Normal saline
Placebo: Normal saline for five days."
577687|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577688|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577689|NCT00936377|E3|Reported Event|Placebo|"Normal saline
Placebo: Normal saline for five days."
577690|NCT00936377|E2|Reported Event|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577691|NCT00936377|E1|Reported Event|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
577692|NCT00936455|B3|Baseline|Total|Total of all reporting groups
577693|NCT00936455|B2|Baseline|Telephone|Telephone evaluated patients
577694|NCT00936455|B1|Baseline|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
577695|NCT00936455|P2|Participant Flow|Telephone|Telephone evaluated patients
577696|NCT00936455|P1|Participant Flow|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
577697|NCT00936455|O2|Outcome|Telephone|Functional Outcome (mRS(0-1)) at 12 months after index event in telephone group
577698|NCT00936455|O1|Outcome|Telemedicine|Functional Outcome (mRS(0-1)) at 12 months after index event in telemedicine group
577699|NCT00936455|O2|Outcome|Telephone|Assessing number of recurrent strokes by 12 months
577700|NCT00936455|O1|Outcome|Telemedicine|Assessing amount of patients that had recurrent stroke by 12 months (patients that retrospectively reporting having had a stroke from 6-12 months after their index event)
577701|NCT00936455|O2|Outcome|Telephone|Recurrent stroke at 6 months in each group
577702|NCT00936455|O1|Outcome|Telemedicine|Assessing amount of patients that had recurrent stroke by 6 months (patients that retrospectively reporting having had a stroke from 0-6 months after their index event)
577703|NCT00936455|O2|Outcome|Telephone|Functional Outcome (mRS(0-1)) at 6 months after index event in the telephone group
577704|NCT00936455|O1|Outcome|Telemedicine|Functional Outcome (mRS(0-1)) at 6 months after index event in the telemedicine group
577705|NCT00936455|E2|Reported Event|Telephone|Telephone evaluated patients
577706|NCT00936455|E1|Reported Event|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
577707|NCT00936481|B3|Baseline|Total|Total of all reporting groups
577708|NCT00936481|B2|Baseline|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
577709|NCT00936481|B1|Baseline|Healthy Controls|18 years or older with body mass index between 25-45
577710|NCT00936481|P2|Participant Flow|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
577714|NCT00936481|O2|Outcome|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
577715|NCT00936481|O1|Outcome|Healthy Controls|18 years or older with body mass index between 25-45
577716|NCT00936481|E2|Reported Event|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
577717|NCT00936481|E1|Reported Event|Healthy Controls|18 years or older with body mass index between 25-45
577718|NCT00936585|B1|Baseline|Immunologic Monitoring|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
577719|NCT00936585|P1|Participant Flow|Immunologic Monitoring|All patients who were enrolled in the main study participated in the NIH sub study and underwent a colonoscopy and blood draw for research specimens for immunologic monitoring before and after study drug administration
577720|NCT00936585|O1|Outcome|Immunologic Monitoring|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
577721|NCT00936585|E1|Reported Event|Colonoscopy|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
577722|NCT00936598|B3|Baseline|Total|Total of all reporting groups
577723|NCT00936598|B2|Baseline|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577724|NCT00936598|B1|Baseline|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577725|NCT00936598|P2|Participant Flow|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577726|NCT00936598|P1|Participant Flow|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577727|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577728|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577729|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577730|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577731|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577732|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577733|NCT00936598|E2|Reported Event|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577734|NCT00936598|E1|Reported Event|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
577735|NCT00936702|B1|Baseline|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
577736|NCT00936702|P1|Participant Flow|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
577782|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577737|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
577738|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
577739|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
577740|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
577741|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
577742|NCT00936702|E1|Reported Event|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
577743|NCT00936715|B1|Baseline|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks
577744|NCT00936715|P1|Participant Flow|FTC/TDF|Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, Truvada®) (200/300 mg) fixed dose combination (FDC) tablet administered once daily for up to 240 weeks.
577745|NCT00936715|O1|Outcome|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks
577746|NCT00936715|E1|Reported Event|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered orally once daily for up to 240 weeks
577747|NCT00936741|B1|Baseline|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
577748|NCT00936741|P1|Participant Flow|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
577749|NCT00936741|O1|Outcome|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
577750|NCT00936741|O1|Outcome|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
577751|NCT00936741|E1|Reported Event|Mifepristone 300 to 1200 mg Daily|mifepristone at doses from 300 mg/day to 1200 mg/day
577752|NCT00936897|B3|Baseline|Total|Total of all reporting groups
577753|NCT00936897|B2|Baseline|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
577754|NCT00936897|B1|Baseline|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
577755|NCT00936897|P2|Participant Flow|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
577756|NCT00936897|P1|Participant Flow|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
577757|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
577758|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
577759|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
577760|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
577761|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
577762|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
577763|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
577764|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
577765|NCT00936897|E2|Reported Event|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
577766|NCT00936897|E1|Reported Event|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
577767|NCT00936975|B1|Baseline|Overall|Participants receiving 100mg PO QD Dasatinib with F18 Sodium Fluoride PET scans at baseline
577768|NCT00936975|P1|Participant Flow|Overall|Participants on the parent study (“Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer”) receiving 100mg PO QD Dasatinib
577769|NCT00936975|O1|Outcome|Overall|Participants receiving 100mg PO QD Dasatinib
577770|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point
fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
577771|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point
fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
577772|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point
fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
577773|NCT00936975|O1|Outcome|Overall|Participants receiving 100mg PO QD Dasatinib
577774|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point
fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
577775|NCT00936975|E1|Reported Event|Overall|Participants receiving 100mg PO QD Dasatinib
577776|NCT00937040|B3|Baseline|Total|Total of all reporting groups
577777|NCT00937040|B2|Baseline|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577778|NCT00937040|B1|Baseline|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577779|NCT00937040|P2|Participant Flow|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577780|NCT00937040|P1|Participant Flow|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577781|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577783|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577784|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577785|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577786|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577787|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577788|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577789|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577790|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577791|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577792|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577793|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577794|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577795|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577796|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577797|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577798|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577799|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577800|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577801|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577802|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577803|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577804|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577805|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577806|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577807|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577808|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577809|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577810|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577811|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577812|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577813|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577814|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577815|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577816|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577817|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577818|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577819|NCT00937040|E2|Reported Event|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
577820|NCT00937040|E1|Reported Event|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
577821|NCT00937105|B3|Baseline|Total|Total of all reporting groups
577822|NCT00937105|B2|Baseline|Lotrafilcon A and Clear Care|
577823|NCT00937105|B1|Baseline|Lotrafilcon A and Renu|
577824|NCT00937105|P2|Participant Flow|Lotrafilcon A Lenses and Renu Multiplus|
577825|NCT00937105|P1|Participant Flow|Lotrafilcon A Lenses and Clear Care|
577826|NCT00937105|O2|Outcome|Participants With no CNS Bioburden on Lid Margins|
577827|NCT00937105|O1|Outcome|Participants With CNS Bioburden on Lid Margins|
577828|NCT00937105|O2|Outcome|Participants With no Microbial Bioburden on Lid Margins|
577829|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lid Margins|
577834|NCT00937105|O2|Outcome|Participants Without Microbial Bioburden on Lenses|
577835|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lenses|
577836|NCT00937105|O2|Outcome|Lotrafilcon A Lenses and Clear Care|
577837|NCT00937105|O1|Outcome|Lotrafilcon A Lenses and Renu|
577838|NCT00937105|E1|Reported Event|Entire Cohort of Lotrafilcon A Users|
577839|NCT00937118|B1|Baseline|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
577840|NCT00937118|P1|Participant Flow|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
577841|NCT00937118|O4|Outcome|Fascial Closure|Patients with full thickness duodenal laceration undergoing laparotomy who did not have damage control and instead had primary fascial closure
577842|NCT00937118|O3|Outcome|Damage Control|Patients with full thickness duodenal laceration undergoing laparotomy who had a damage control technique
577843|NCT00937118|O2|Outcome|Diversion Decompression or Exclusion|Patients with full thickness duodenal laceration undergoing laparotomy who did have diversion, decompression, or exclusion techniques
577844|NCT00937118|O1|Outcome|No Diversion Decompression or Exclusion|Patients with full thickness duodenal laceration undergoing laparotomy who did not have diversion, decompression, or exclusion techniques
578094|NCT00937833|E1|Reported Event|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
577845|NCT00937118|E1|Reported Event|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
577846|NCT00937157|B1|Baseline|Patients Diagnosed With Multiple Sclerosis Who Have the Presen|Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
577847|NCT00937157|P1|Participant Flow|RRMS Patients With >=1 GdE Lesion or Acute Relapse|"Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.
Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days."
577848|NCT00937157|O1|Outcome|Patients Diagnosed With Multiple Sclerosis Who Have the Presen|Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
577849|NCT00937157|E1|Reported Event|RRMS Patients With >=1 GdE Lesion or Acute Relapse|"Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.
Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days."
577850|NCT00937391|B3|Baseline|Total|Total of all reporting groups
577851|NCT00937391|B2|Baseline|Gadopentetate Dimeglumine (Magnevist, BAY86-6661) – Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577852|NCT00937391|B1|Baseline|Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577853|NCT00937391|P1|Participant Flow|Gadopentetate Dimeglumine (Magnevist, BAY86-6661)|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Another group of participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577854|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577855|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577856|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
577857|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577858|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577859|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
577860|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
578056|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
577861|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577862|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577863|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
577864|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577865|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
577866|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
577867|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
578412|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
577868|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577869|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
577870|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577871|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577872|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
577873|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577874|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577875|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577876|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
577877|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577878|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
577879|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
577880|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577881|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
577882|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577883|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
577884|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
577885|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577886|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
577887|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577888|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
577889|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
577890|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577891|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577892|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577893|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577945|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577894|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577895|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577896|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577897|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
577898|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577899|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577900|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
577901|NCT00937391|E2|Reported Event|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
577902|NCT00937391|E1|Reported Event|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
577903|NCT00937495|B1|Baseline|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
577904|NCT00937495|P1|Participant Flow|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
577905|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
577906|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
577907|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
577908|NCT00937495|E1|Reported Event|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
577909|NCT00937521|B9|Baseline|Total|Total of all reporting groups
577910|NCT00937521|B8|Baseline|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577911|NCT00937521|B7|Baseline|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577912|NCT00937521|B6|Baseline|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577913|NCT00937521|B5|Baseline|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577914|NCT00937521|B4|Baseline|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577915|NCT00937521|B3|Baseline|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577916|NCT00937521|B2|Baseline|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577917|NCT00937521|B1|Baseline|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577918|NCT00937521|P8|Participant Flow|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577919|NCT00937521|P7|Participant Flow|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577920|NCT00937521|P6|Participant Flow|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577921|NCT00937521|P5|Participant Flow|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577922|NCT00937521|P4|Participant Flow|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577923|NCT00937521|P3|Participant Flow|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577924|NCT00937521|P2|Participant Flow|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577925|NCT00937521|P1|Participant Flow|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577926|NCT00937521|O1|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577927|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577928|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577929|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577930|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577931|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577932|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577933|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577934|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577935|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577936|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577937|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577938|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577939|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577940|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577941|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577942|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577943|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577944|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
578088|NCT00937833|B1|Baseline|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
577946|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577947|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577948|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577949|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577950|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577951|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577952|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577953|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577954|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577955|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577956|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577957|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577958|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577959|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577960|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577961|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577962|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577963|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577964|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577965|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577966|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577967|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577968|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577969|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
577970|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal multi-component recombinant, adsorbed vaccine (formulation V)and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577971|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577972|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577973|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577974|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
577975|NCT00937521|O1|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577976|NCT00937521|O2|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577977|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577978|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577979|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577980|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577981|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577982|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577983|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577984|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577985|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577986|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577987|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
577988|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577989|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577990|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
577991|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577992|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577993|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
577994|NCT00937521|O2|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577995|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577996|NCT00937521|O2|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577997|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
577998|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
577999|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
578000|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578001|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578002|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578003|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578004|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578005|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578006|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
578007|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
578008|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578009|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578010|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578011|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578012|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578013|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578014|NCT00937521|E16|Reported Event|Par+B+OMV (Group VIII) Booster Phase|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase.
578015|NCT00937521|E15|Reported Event|MenC (Group VII) Booster Phase|"Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.
Group defined to include Booster Phase."
578016|NCT00937521|E14|Reported Event|PH2 B+OMV (Group VI) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase."
578017|NCT00937521|E13|Reported Event|½ (B+OMV) (Group V) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase."
578018|NCT00937521|E12|Reported Event|B (Group IV) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase."
578019|NCT00937521|E11|Reported Event|B+1/4 OMV (Group III) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase."
578020|NCT00937521|E10|Reported Event|B+½ OMV (Group II) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine(formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase."
578057|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
578021|NCT00937521|E9|Reported Event|B+OMV (Group I) Booster Phase|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
578022|NCT00937521|E8|Reported Event|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting.
578023|NCT00937521|E7|Reported Event|MenC (Group VII)|"Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting."
578024|NCT00937521|E6|Reported Event|PH2 B+OMV (Group VI)|"SubjSubjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting."
578089|NCT00937833|P2|Participant Flow|Control|No sling placed at the time of prostatectomy
578090|NCT00937833|P1|Participant Flow|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
578025|NCT00937521|E5|Reported Event|½ (B+OMV) (Group V)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting."
578026|NCT00937521|E4|Reported Event|B (Group IV)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.."
578027|NCT00937521|E3|Reported Event|B+1/4 OMV (Group III)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting."
578028|NCT00937521|E2|Reported Event|B+½ OMV (Group II)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting."
578029|NCT00937521|E1|Reported Event|B+OMV (Group I)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting."
578030|NCT00937547|B4|Baseline|Total|Total of all reporting groups
578031|NCT00937547|B3|Baseline|Intraepithelial Cervical Neoplasia 2|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
578032|NCT00937547|B2|Baseline|Intraepithelial Cervical Neoplasia 3|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3
578033|NCT00937547|B1|Baseline|Invasive Cervical Cancer|Paraffin-embedded samples with histological diagnosis of invasive cervical cancer
578034|NCT00937547|P3|Participant Flow|Cervical Intraepithelial Neoplasia 3|patients with histological diagnosis of cervical intraepithelial neoplasia grade 3
578035|NCT00937547|P2|Participant Flow|Cervical Intraepithelial Neoplasia 2|patients with histological diagnosis of cervical intraepithelial neoplasia grade 2
578036|NCT00937547|P1|Participant Flow|Invasive Cervical Cancer|patients with histologic diagnosis invasive cervical cancer.
578037|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
578038|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
578039|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
578040|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
578041|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
578042|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
578043|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
578044|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
578045|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
578046|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
578047|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
578048|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
578049|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
578050|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
578051|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
578052|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
578053|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
578054|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
578055|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
578058|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
578059|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
578060|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
578061|NCT00937547|E3|Reported Event|Intraepithelial Cervical Neoplasia 2|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
578062|NCT00937547|E2|Reported Event|Intraepithelial Cervical Neoplasia 3|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3
578063|NCT00937547|E1|Reported Event|Invasive Cervical Cancer|Paraffin-embedded samples with histological diagnosis of invasive cervical cancer
578091|NCT00937833|O2|Outcome|Control|No sling placed at the time of prostatectomy
578092|NCT00937833|O1|Outcome|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
578093|NCT00937833|E2|Reported Event|Control|No sling placed at the time of prostatectomy
578064|NCT00937560|B1|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
578065|NCT00937560|P1|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
578066|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
578067|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
578068|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone. Only participants with measureable disease were included in the analysis according to RECIST only. Only participants with an ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal were included in the analysis according to CA-125 level only.
578069|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
578070|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
578071|NCT00937560|E1|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|"Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
Bevacizumab: Bevacizumab was supplied as a sterile solution for infusion.
Paclitaxel: Paclitaxel was supplied locally in commercial batches.
Carboplatin: Carboplatin was supplied locally in commercial batches."
578072|NCT00937768|B3|Baseline|Total|Total of all reporting groups
578073|NCT00937768|B2|Baseline|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
578074|NCT00937768|B1|Baseline|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
578075|NCT00937768|P2|Participant Flow|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
578076|NCT00937768|P1|Participant Flow|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
578077|NCT00937768|O2|Outcome|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
578078|NCT00937768|O1|Outcome|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
578079|NCT00937768|E2|Reported Event|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
578080|NCT00937768|E1|Reported Event|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
578081|NCT00937794|B1|Baseline|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
578082|NCT00937794|P1|Participant Flow|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
578083|NCT00937794|O1|Outcome|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
578084|NCT00937794|O1|Outcome|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
578085|NCT00937794|E1|Reported Event|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
578086|NCT00937833|B3|Baseline|Total|Total of all reporting groups
578087|NCT00937833|B2|Baseline|Control|No sling placed at the time of prostatectomy
578095|NCT00937937|B1|Baseline|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578096|NCT00937937|P1|Participant Flow|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578097|NCT00937937|O1|Outcome|Dinaciclib|
578098|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578099|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578100|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578101|NCT00937937|E1|Reported Event|SCH 727965|
578102|NCT00937950|B1|Baseline|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578103|NCT00937950|P1|Participant Flow|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578104|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578105|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578106|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578107|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578108|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578109|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578110|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578111|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578112|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578113|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578114|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578115|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578116|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578117|NCT00937950|E1|Reported Event|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
578118|NCT00938015|B1|Baseline|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578119|NCT00938015|P1|Participant Flow|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578120|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578121|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578122|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578123|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578124|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578125|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578126|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578127|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578128|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578129|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578130|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578131|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578132|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578133|NCT00938015|E1|Reported Event|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
578134|NCT00938041|B1|Baseline|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
578135|NCT00938041|P1|Participant Flow|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
578136|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
578137|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
578138|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
578139|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
578158|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578140|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
578141|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
578142|NCT00938041|E1|Reported Event|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
578143|NCT00929071|B1|Baseline|Pain Assessment|Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
578144|NCT00929071|P1|Participant Flow|All Study Participants|Assess a difference in immediate post-injection pain of Evolence/topical anesthetic at the left nasolabial fold vs Evolence/Lidocaine at the right nasolabial fold.
578145|NCT00929071|O2|Outcome|Pain Assessment for Evolence/Lidocaine|"Assess injection pain of Evolence/Lidocaine
collagen: Injectable collagen
Lidocaine: admix anesthetic"
578146|NCT00929071|O1|Outcome|Pain Assessment for Evolence/Topical Anesthetic|"Assess injection pain of Evolence/topical anesthetic
collagen: Injectable collagen
topical anesthetic"
578147|NCT00929071|O2|Outcome|Pain Assessment for Evolence/Lidocaine|"Assess injection pain of Evolence/Lidocaine right nasolabial fold
collagen: Injectable collagen
Lidocaine: admix anesthetic"
578148|NCT00929071|O1|Outcome|Pain Assessment for Evolence/Topical Anesthetic|"Assess injection pain of Evolence/topical anesthetic left nasolabial fold
collagen: Injectable collagen
topical anesthetic"
578149|NCT00929071|E1|Reported Event|Pain Assessment|Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
578150|NCT00929110|B4|Baseline|Total|Total of all reporting groups
578151|NCT00929110|B3|Baseline|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578152|NCT00929110|B2|Baseline|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578153|NCT00929110|B1|Baseline|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578154|NCT00929110|P3|Participant Flow|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578155|NCT00929110|P2|Participant Flow|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578156|NCT00929110|P1|Participant Flow|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578157|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578159|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578160|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578161|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578162|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578163|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578164|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578165|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578166|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578167|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578168|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578169|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578170|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578171|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578172|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578173|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578174|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578175|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578176|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578177|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578178|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578179|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578180|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578181|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578182|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578183|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578184|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578185|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578186|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578187|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578188|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578189|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578190|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578191|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578192|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578193|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578194|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578195|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578196|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578197|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578198|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578199|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578200|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578201|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578202|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578203|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578204|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578205|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578206|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578207|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578208|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578209|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578210|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578211|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578212|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578213|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578214|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578215|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578216|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578217|NCT00929110|E3|Reported Event|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578218|NCT00929110|E2|Reported Event|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578219|NCT00929110|E1|Reported Event|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
578220|NCT00929162|B3|Baseline|Total|Total of all reporting groups
578221|NCT00929162|B2|Baseline|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578222|NCT00929162|B1|Baseline|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578223|NCT00929162|P2|Participant Flow|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578224|NCT00929162|P1|Participant Flow|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578225|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578226|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578227|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578228|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578229|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578230|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578231|NCT00929162|E2|Reported Event|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578232|NCT00929162|E1|Reported Event|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
578233|NCT00929201|B1|Baseline|All Participants|All randomized participants
578234|NCT00929201|P2|Participant Flow|Sita/Met FDC Then Sita + Met|Sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
578235|NCT00929201|P1|Participant Flow|Sita + Met Then Sita/Met FDC|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg fixed-dose combination (FDC) tablet administered as a single dose during Period 2.
578236|NCT00929201|O2|Outcome|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
578237|NCT00929201|O1|Outcome|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
578238|NCT00929201|O2|Outcome|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg final marketed image (FMI) FDC tablet administered as a single dose
578239|NCT00929201|O1|Outcome|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
578240|NCT00929201|E2|Reported Event|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
578241|NCT00929201|E1|Reported Event|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
578242|NCT00929240|B1|Baseline|Intial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
578292|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578413|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
578243|NCT00929240|P3|Participant Flow|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578244|NCT00929240|P2|Participant Flow|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (partial response [PR] or complete response [CR]) or disease stabilization (SD) received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578245|NCT00929240|P1|Participant Flow|Initial Treatment Phase: Bevacizumab Plus (+) Docetaxel|During the Initial Phase all participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 milligrams per square meter (mg/m^2) IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
578246|NCT00929240|O1|Outcome|Initial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
578247|NCT00929240|O1|Outcome|Initial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion.At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
578248|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578249|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578250|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578293|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578294|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578251|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578252|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578253|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578254|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578255|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578256|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578257|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578258|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578295|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578414|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
578259|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578260|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578261|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578262|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578263|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578264|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578265|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578266|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578296|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578486|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578267|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578268|NCT00929240|E3|Reported Event|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
578269|NCT00929240|E2|Reported Event|Maintenance Phase:Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
578270|NCT00929240|E1|Reported Event|Initial Treatment Phase:Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
578271|NCT00929305|B3|Baseline|Total|Total of all reporting groups
578272|NCT00929305|B2|Baseline|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
578273|NCT00929305|B1|Baseline|Placebo Laser|inactive laser light
578274|NCT00929305|P2|Participant Flow|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
578275|NCT00929305|P1|Participant Flow|Placebo Laser|inactive laser light
578276|NCT00929305|O2|Outcome|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
578277|NCT00929305|O1|Outcome|Placebo Laser|inactive laser light
578382|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
581164|NCT00943852|O2|Outcome|Placebo|
578278|NCT00929305|O2|Outcome|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
578279|NCT00929305|O1|Outcome|Placebo Laser|inactive laser light
578280|NCT00929305|E2|Reported Event|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
578281|NCT00929305|E1|Reported Event|Placebo Laser|inactive laser light
578282|NCT00938314|B5|Baseline|Total|Total of all reporting groups
578283|NCT00938314|B4|Baseline|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578284|NCT00938314|B3|Baseline|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578285|NCT00938314|B2|Baseline|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578286|NCT00938314|B1|Baseline|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578287|NCT00938314|P4|Participant Flow|Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578288|NCT00938314|P3|Participant Flow|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578289|NCT00938314|P2|Participant Flow|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578290|NCT00938314|P1|Participant Flow|NTx®-265 Low Dose|human chorionic gonadotropin (hCG) 385 µg (10,000 international unit [IU]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then epoetin alfa (EPO) 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation
578291|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578407|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
578297|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578298|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578299|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578300|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578301|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578302|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578303|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578304|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578305|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578306|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578307|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578308|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578309|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578310|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578311|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578312|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578313|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578314|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578315|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578383|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578316|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578317|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578318|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578319|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578320|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578321|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578322|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578323|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578324|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578325|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578326|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578327|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578328|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578329|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578330|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578331|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578332|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578333|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578408|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
578334|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578335|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578336|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578337|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578338|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578339|NCT00938314|E4|Reported Event|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
578340|NCT00938314|E3|Reported Event|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
578341|NCT00938314|E2|Reported Event|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
578342|NCT00938314|E1|Reported Event|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
578343|NCT00938327|B1|Baseline|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
578344|NCT00938327|P1|Participant Flow|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
578345|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
578346|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
578347|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
578348|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
578349|NCT00938327|E1|Reported Event|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
578350|NCT00938366|B3|Baseline|Total|Total of all reporting groups
578384|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578799|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
578351|NCT00938366|B2|Baseline|Cladribine + Pantoprazole Followed by Cladribine|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After a wash out period of 10-25 days, subjects received a single 10 mg cladribine dose orally.
578352|NCT00938366|B1|Baseline|Cladribine Followed by Cladribine + Pantoprazole|Subjects received a single 10 milligram (mg) cladribine dose orally on Day 1 followed by a wash out period of 10-25 days. Subjects then received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After administration of cladribine, subjects were required to fast for an additional 2 hours.
578353|NCT00938366|P2|Participant Flow|Cladribine + Pantoprazole Followed by Cladribine|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After a wash out period of 10-25 days, subjects received a single 10 mg cladribine dose orally.
578354|NCT00938366|P1|Participant Flow|Cladribine Followed by Cladribine + Pantoprazole|Subjects received a single 10 milligram (mg) cladribine dose orally on Day 1 followed by a wash out period of 10-25 days. Subjects then received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post pantoprazole dose on second day. After administration of cladribine, subjects were required to fast for an additional 2 hours.
578355|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
578356|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
578357|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
578358|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
578359|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
578360|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
578409|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
578410|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
578361|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
578362|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
578363|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
578364|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
578365|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
578366|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
578367|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
578368|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
578369|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
578370|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
578371|NCT00938366|E2|Reported Event|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
578372|NCT00938366|E1|Reported Event|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
578373|NCT00938392|B3|Baseline|Total|Total of all reporting groups
578374|NCT00938392|B2|Baseline|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578375|NCT00938392|B1|Baseline|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578376|NCT00938392|P2|Participant Flow|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578377|NCT00938392|P1|Participant Flow|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578378|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578379|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578380|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578381|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578385|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578386|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578387|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578388|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578389|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578390|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578391|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578392|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578393|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578394|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578395|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578396|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578397|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578398|NCT00938392|E2|Reported Event|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
578399|NCT00938392|E1|Reported Event|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
578400|NCT00938431|B4|Baseline|Total Title|
578401|NCT00938431|B3|Baseline|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578402|NCT00938431|B2|Baseline|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578403|NCT00938431|B1|Baseline|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578404|NCT00938431|P3|Participant Flow|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578405|NCT00938431|P2|Participant Flow|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578406|NCT00938431|P1|Participant Flow|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578415|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578416|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578417|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578418|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578419|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578420|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578421|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578422|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578423|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578424|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578425|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578426|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578427|NCT00938431|E3|Reported Event|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578428|NCT00938431|E2|Reported Event|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578429|NCT00938431|E1|Reported Event|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
578430|NCT00938860|B3|Baseline|Total|Total of all reporting groups
578431|NCT00938860|B2|Baseline|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578455|NCT00938886|B3|Baseline|Total|Total of all reporting groups
578456|NCT00938886|B2|Baseline|Placebo|"Daily matched placebo pill
Placebo: Matched naltrexone placebo"
578457|NCT00938886|B1|Baseline|Naltrexone|"50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone"
578432|NCT00938860|B1|Baseline|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578433|NCT00938860|P2|Participant Flow|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578434|NCT00938860|P1|Participant Flow|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578435|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578436|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578437|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578438|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578439|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578440|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578441|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578442|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578443|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578487|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578444|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578445|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578446|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578447|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578448|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578449|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578450|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578451|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578452|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578453|NCT00938860|E2|Reported Event|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
578454|NCT00938860|E1|Reported Event|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
578458|NCT00938886|P2|Participant Flow|Placebo|"Daily matched placebo pill
Placebo: Matched naltrexone placebo"
578459|NCT00938886|P1|Participant Flow|Naltrexone|"50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone"
578460|NCT00938886|O2|Outcome|Placebo|"Daily matched placebo pill
Placebo: Matched naltrexone placebo"
578461|NCT00938886|O1|Outcome|Naltrexone|"50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone"
578462|NCT00938886|O2|Outcome|Placebo|"Daily matched placebo pill
Placebo: Matched naltrexone placebo"
578463|NCT00938886|O1|Outcome|Naltrexone|"50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone"
578464|NCT00938886|E2|Reported Event|Placebo|"Daily matched placebo pill
Placebo: Matched naltrexone placebo"
578465|NCT00938886|E1|Reported Event|Naltrexone|"50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone"
578466|NCT00938964|B3|Baseline|Total|Total of all reporting groups
578467|NCT00938964|B2|Baseline|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578468|NCT00938964|B1|Baseline|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578469|NCT00938964|P2|Participant Flow|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578470|NCT00938964|P1|Participant Flow|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578471|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578472|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578473|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578474|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578475|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578476|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578477|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578478|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578479|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578480|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578481|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578482|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578483|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578484|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578485|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578488|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578489|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578490|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578491|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578492|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578493|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578494|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578495|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578496|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578497|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578498|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578499|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578500|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578501|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578502|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578503|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578504|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578505|NCT00938964|E2|Reported Event|Placebo|"Normal saline infusion for 48 hours
Placebo: Lidocaine versus placebo infusion for 48 hours"
578506|NCT00938964|E1|Reported Event|Lidocaine|"Lidocaine infusion for 48 hours
Lidocaine: Lidocaine versus placebo infusion for 48 hours"
578507|NCT00939003|B3|Baseline|Total|Total of all reporting groups
578508|NCT00939003|B2|Baseline|Double-blind Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
578509|NCT00939003|B1|Baseline|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
578510|NCT00939003|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
578511|NCT00939003|P1|Participant Flow|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
578512|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
578513|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
578514|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
578515|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
578516|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
578517|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
578518|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578519|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578520|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578521|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578522|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578523|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578524|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578525|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578526|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578527|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578528|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578529|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578530|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578531|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578581|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
578532|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578533|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578534|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578535|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578536|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578537|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578538|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578539|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578540|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
578541|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
578542|NCT00939003|E3|Reported Event|Any Adalimumab|Participants who received any dose of adalimumab during the 12-week double-blind period or during the 144-week open-label period.
578543|NCT00939003|E2|Reported Event|Double-blind Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period.
578544|NCT00939003|E1|Reported Event|Double-blind Placebo|Participants received placebo every other week for 12 weeks during the double-blind period.
578545|NCT00939029|B3|Baseline|Total|Total of all reporting groups
578546|NCT00939029|B2|Baseline|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
578547|NCT00939029|B1|Baseline|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
578548|NCT00939029|P2|Participant Flow|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
578549|NCT00939029|P1|Participant Flow|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
578550|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
578551|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
578552|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
578553|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
578554|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
578555|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
578556|NCT00939029|E2|Reported Event|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
578557|NCT00939029|E1|Reported Event|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
578558|NCT00939055|B3|Baseline|Total|Total of all reporting groups
578559|NCT00939055|B2|Baseline|Sham Procedure|"No intervention
Sham procedure: False procedure"
578560|NCT00939055|B1|Baseline|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.
StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.
GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
578561|NCT00939055|P2|Participant Flow|Sham Procedure|"No intervention
Sham procedure: False procedure"
578562|NCT00939055|P1|Participant Flow|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.
StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.
GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
578563|NCT00939055|O2|Outcome|Sham Procedure|"No intervention
Sham procedure: False procedure"
578564|NCT00939055|O1|Outcome|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.
StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.
GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
578565|NCT00939055|O2|Outcome|Sham|No intervention
578566|NCT00939055|O1|Outcome|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.
StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.
GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
578567|NCT00939055|E2|Reported Event|Sham|No intervention
578568|NCT00939055|E1|Reported Event|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.
StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.
GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
578569|NCT00939094|B3|Baseline|Total|Total of all reporting groups
578570|NCT00939094|B2|Baseline|2 - Placebo|Placebo, capsule
578571|NCT00939094|B1|Baseline|A - AZD2066|AZD2066, 12 mg capsule
578572|NCT00939094|P2|Participant Flow|2 - Placebo|Placebo, capsule
578573|NCT00939094|P1|Participant Flow|A - AZD2066|AZD2066, 12 mg capsule
578574|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
578575|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
578576|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
578577|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
578578|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
578579|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
578580|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
578593|NCT00939107|B2|Baseline|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
578594|NCT00939107|B1|Baseline|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
578595|NCT00939107|P2|Participant Flow|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
578596|NCT00939107|P1|Participant Flow|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
578597|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
578598|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
578599|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
578600|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
578601|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
578602|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
578603|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
578604|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
578605|NCT00939107|E2|Reported Event|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
578606|NCT00939107|E1|Reported Event|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
578607|NCT00939120|B3|Baseline|Total|Total of all reporting groups
578709|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578608|NCT00939120|B2|Baseline|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578609|NCT00939120|B1|Baseline|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578610|NCT00939120|P2|Participant Flow|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578611|NCT00939120|P1|Participant Flow|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578612|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578613|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578614|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578615|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578616|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578617|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578618|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578619|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578620|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578621|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578622|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578623|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578624|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578625|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578626|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578627|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578628|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578629|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578630|NCT00939120|E2|Reported Event|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
578631|NCT00939120|E1|Reported Event|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
578632|NCT00939159|B1|Baseline|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
578633|NCT00939159|P1|Participant Flow|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
578634|NCT00939159|O1|Outcome|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
578635|NCT00939159|E1|Reported Event|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
578636|NCT00939185|B1|Baseline|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
578637|NCT00939185|P1|Participant Flow|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
578638|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
578639|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
578710|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578640|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
578641|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
578642|NCT00939185|E1|Reported Event|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
578643|NCT00939211|B1|Baseline|Overall Number of Baseline Participants|
578644|NCT00939211|P1|Participant Flow|Entire Study Population|
578645|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
578646|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578647|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578648|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578649|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578650|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
578651|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578652|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578653|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578654|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578655|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
578656|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578657|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578658|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578659|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578660|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
624827|NCT01055704|O4|Outcome|Placebo|
578661|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578662|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578663|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578664|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578665|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
578666|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578667|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578668|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578669|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578670|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
578671|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578711|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578712|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578672|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578673|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578674|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578675|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
578676|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578677|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578678|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578679|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578680|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
578681|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578682|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578683|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578684|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578685|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
578686|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578687|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578688|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578689|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578690|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
578691|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578692|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578693|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578694|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578695|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
578696|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578697|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578698|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578699|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578700|NCT00939211|E5|Reported Event|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
578701|NCT00939211|E4|Reported Event|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
578702|NCT00939211|E3|Reported Event|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578703|NCT00939211|E2|Reported Event|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578704|NCT00939211|E1|Reported Event|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
578705|NCT00939341|B1|Baseline|Symbicort Turbuhaler|160/4.5 µg delivered dose
578706|NCT00939341|P1|Participant Flow|Symbicort Turbuhaler|160/4.5 µg delivered dose
578707|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578708|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578713|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578714|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578715|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578716|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578717|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578718|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578719|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578720|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578721|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578722|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578723|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
578724|NCT00939341|E1|Reported Event|Symbicort Turbuhaler|160/4.5 µg delivered dose
578725|NCT00939367|B1|Baseline|All Study Participants|Torrent's Zolpidem Tartrate Tablets 10 mg and Ambien® 10mg tablets
578726|NCT00939367|P2|Participant Flow|Ambien First, Then Torrent's Zolpidem|"For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg
Followed by a 7 day washout period.
For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg."
578727|NCT00939367|P1|Participant Flow|Torrent's Zolpidem First, Then Ambien|"For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.
Followed by a 7 day washout period.
For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg."
578728|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
578729|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
578730|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
578731|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
578732|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
578733|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
578734|NCT00939367|E2|Reported Event|Active Comparator|Ambien® 10mg tablets
578735|NCT00939367|E1|Reported Event|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
578736|NCT00939393|B3|Baseline|Total|Total of all reporting groups
578737|NCT00939393|B2|Baseline|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
578738|NCT00939393|B1|Baseline|Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
578739|NCT00939393|P2|Participant Flow|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
578740|NCT00939393|P1|Participant Flow|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
578741|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery (ESS) performed in the operating room (OR) with or without balloon sinus dilation devices.
578742|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery (ESS) performed in physician's office (IO, or In Office) using balloon sinus dilation device.
578743|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
578744|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
578745|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
578746|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
578747|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
578748|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
580346|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
578749|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
578750|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
578751|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
578752|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
578753|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
578754|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
578755|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
578756|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
578757|NCT00939393|E2|Reported Event|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
578758|NCT00939393|E1|Reported Event|Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
578759|NCT00939471|B1|Baseline|Balloon Device|Balloon catheter dilation of sinus ostia
578760|NCT00939471|P1|Participant Flow|Balloon Device|Balloon catheter dilation of sinus ostia
578761|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
578762|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
578763|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
578764|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
578765|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
578766|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
578767|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
578768|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
578769|NCT00939471|E1|Reported Event|Balloon Device|Balloon catheter dilation of sinus ostia
578770|NCT00939484|B4|Baseline|Total|Total of all reporting groups
578771|NCT00939484|B3|Baseline|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
578772|NCT00939484|B2|Baseline|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
578773|NCT00939484|B1|Baseline|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
578774|NCT00939484|P3|Participant Flow|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
578775|NCT00939484|P2|Participant Flow|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
578776|NCT00939484|P1|Participant Flow|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
578777|NCT00939484|O1|Outcome|PBTC025B|Adult patients with a histologically confirmed diagnosis of medulloblastoma (including posterior fossa PNET) that is recurrent, progressive, or refractory.
578778|NCT00939484|O1|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
578779|NCT00939484|O3|Outcome|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
578780|NCT00939484|O2|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
578781|NCT00939484|O1|Outcome|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
578782|NCT00939484|O3|Outcome|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
578783|NCT00939484|O2|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
578784|NCT00939484|O1|Outcome|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
578785|NCT00939484|E3|Reported Event|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
578786|NCT00939484|E2|Reported Event|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
578787|NCT00939484|E1|Reported Event|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
578788|NCT00939510|B1|Baseline|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
578789|NCT00939510|P1|Participant Flow|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
578790|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
578791|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
578792|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
578793|NCT00939510|E1|Reported Event|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
578794|NCT00939536|B3|Baseline|Total|Total of all reporting groups
578795|NCT00939536|B2|Baseline|Active Comparator|Ambien® 10mg tablets
578796|NCT00939536|B1|Baseline|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
578797|NCT00939536|P2|Participant Flow|Ambien First, Then Torrent's Zolpidem|"For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg
Followed by a 7 day washout period.
For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg."
578798|NCT00939536|P1|Participant Flow|Torrent's Zolpidem First, Then Ambien|"For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.
Followed by a 7 day washout period.
For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg."
578800|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
578801|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
578802|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
578803|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
578804|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
578805|NCT00939536|E2|Reported Event|Active Comparator|Ambien® 10mg tablets
578806|NCT00939536|E1|Reported Event|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
578807|NCT00939562|B1|Baseline|Entire Study Population|Includes subjects who received a single dose of one 100 mg doxycycline monohydrate tablet (Test) and a single dose of one 100 mg doxycycline carragenate tablet (Reference).
578808|NCT00939562|P2|Participant Flow|Doxycycline Carragenate, Then Doxycycline Monohydrate|Single dose of one 100 mg doxycycline carragenate tablet (Reference) during first period and single dose of one 100 mg doxycycline monohydrate tablet (Test) during the second period.
578809|NCT00939562|P1|Participant Flow|Doxycycline Monohydrate, Then Doxycycline Carragenate|Single dose of one 100 mg doxycycline monohydrate tablet (Test) during first period and single dose of one 100 mg doxycycline carragenate tablet (Reference) during the second period.
578810|NCT00939562|O2|Outcome|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
578811|NCT00939562|O1|Outcome|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
578812|NCT00939562|O2|Outcome|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
578813|NCT00939562|O1|Outcome|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
578814|NCT00939562|E2|Reported Event|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
578815|NCT00939562|E1|Reported Event|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
578816|NCT00939627|B3|Baseline|Total|Total of all reporting groups
578817|NCT00939627|B2|Baseline|Arm B - Cetuximab and Sorafenib Tosylate|Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
578818|NCT00939627|B1|Baseline|Arm A - Cetuximab|Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
578819|NCT00939627|P3|Participant Flow|Participants Who Did Not Receive Treatment.|Placebo Arm: The protocol was amended and this arm was removed.
578820|NCT00939627|P2|Participant Flow|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
578821|NCT00939627|P1|Participant Flow|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility..
578822|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
578823|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
578824|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
578825|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
578826|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
578827|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
578828|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
578829|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
578830|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
578831|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
578832|NCT00939627|E2|Reported Event|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
578833|NCT00939627|E1|Reported Event|Arm A - Cetuximab|Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
578834|NCT00939692|B3|Baseline|Total|Total of all reporting groups
578835|NCT00939692|B2|Baseline|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
578836|NCT00939692|B1|Baseline|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
581165|NCT00943852|O1|Outcome|Losartan 100 mg + ISMN 60 mg|
578837|NCT00939692|P2|Participant Flow|Topamax First, Then Torrent's Topiramate|"For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.
Followed by a 21 day washout period.
For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg."
578838|NCT00939692|P1|Participant Flow|Torrent's Topiramate First, Then Topamax|"For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.
Followed by a 21 day washout period.
For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg."
578839|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
578840|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
578841|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
578842|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
578843|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
578844|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
578845|NCT00939692|E2|Reported Event|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
578846|NCT00939692|E1|Reported Event|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
578847|NCT00939705|B3|Baseline|Total|Total of all reporting groups
578848|NCT00939705|B2|Baseline|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
578849|NCT00939705|B1|Baseline|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
578850|NCT00939705|P2|Participant Flow|Topamax First, Then Torrent's Topiramate|"For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.
Followed by a 21 day washout period.
For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg."
578851|NCT00939705|P1|Participant Flow|Torrent's Topiramate First, Then Topamax|"For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.
Followed by a 21 day washout period.
For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg."
578852|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
578853|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
578854|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
578855|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
578856|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
578857|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
578858|NCT00939705|E2|Reported Event|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
578859|NCT00939705|E1|Reported Event|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
578860|NCT00939731|B1|Baseline|Entire Study Population|Includes participants randomized to receive PF-02341066 250 mg IRT first and PF-02341066 250 mg PIC first.
578894|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
578861|NCT00939731|P2|Participant Flow|PF-02341066 250 mg PIC First, Then PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg PIC in first intervention period; and single oral dose of PF-02341066 250 mg IRT in second intervention period. A washout period of at least 14 days was maintained between each period.
578862|NCT00939731|P1|Participant Flow|PF-02341066 250 mg IRT First, Then PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg immediate release tablet (IRT) in first intervention period; and single oral dose of PF-02341066 250 mg powder in capsule (PIC) in second intervention period. A washout period of at least 14 days was maintained between each period.
578863|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
578864|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
578865|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
578866|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
578867|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
578868|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
578869|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
578870|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
578871|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
578872|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
579412|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
578873|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
578874|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
578875|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
578876|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
578877|NCT00939731|E2|Reported Event|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
578878|NCT00939731|E1|Reported Event|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
578879|NCT00939783|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
578880|NCT00939783|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
578881|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
578882|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
578883|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
578884|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
578885|NCT00939783|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
578886|NCT00939796|B1|Baseline|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
578887|NCT00939796|P1|Participant Flow|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
578888|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
578889|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
578890|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
578891|NCT00939796|E1|Reported Event|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
578892|NCT00939809|B1|Baseline|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
578893|NCT00939809|P1|Participant Flow|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
579450|NCT00933608|O1|Outcome|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
578895|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
578896|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
578897|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
578898|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
578899|NCT00939809|E1|Reported Event|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
578900|NCT00939874|B1|Baseline|Raltegravir|Raltegravir: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
578901|NCT00939874|P1|Participant Flow|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
578902|NCT00939874|O1|Outcome|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
578903|NCT00939874|O1|Outcome|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
578904|NCT00939874|E1|Reported Event|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
578905|NCT00939900|B3|Baseline|Total|Total of all reporting groups
578906|NCT00939900|B2|Baseline|Control|control group
579413|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
581166|NCT00943852|O2|Outcome|Losartan 100 mg|
578907|NCT00939900|B1|Baseline|Aclasta|"aclasta group
zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
578908|NCT00939900|P2|Participant Flow|Control|control group
578909|NCT00939900|P1|Participant Flow|Aclasta|"aclasta group
zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
578910|NCT00939900|O2|Outcome|Control|control group
578911|NCT00939900|O1|Outcome|Aclasta|"aclasta group
zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
578912|NCT00939900|E2|Reported Event|Control|control group
578913|NCT00939900|E1|Reported Event|Aclasta|"aclasta group
zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
578914|NCT00939952|B1|Baseline|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
578915|NCT00939952|P1|Participant Flow|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
578916|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
578917|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
578918|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
578919|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
578920|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
578921|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
578922|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
578923|NCT00939952|E1|Reported Event|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
578924|NCT00939991|B3|Baseline|Total|Total of all reporting groups
578925|NCT00939991|B2|Baseline|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
578926|NCT00939991|B1|Baseline|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
578927|NCT00939991|P2|Participant Flow|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
578928|NCT00939991|P1|Participant Flow|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
579019|NCT00940290|P3|Participant Flow|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
578929|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
578930|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
578931|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
578932|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
578933|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
578934|NCT00939991|O1|Outcome|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
578935|NCT00939991|E2|Reported Event|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
578972|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579414|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
578936|NCT00939991|E1|Reported Event|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
578937|NCT00940017|B1|Baseline|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578938|NCT00940017|P1|Participant Flow|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578939|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578940|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578941|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578942|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578943|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578960|NCT00940108|B1|Baseline|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579067|NCT00940537|E2|Reported Event|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
578944|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578945|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578946|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578947|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578948|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578949|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578973|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579415|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
578950|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578951|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578952|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578953|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578954|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578955|NCT00940017|E1|Reported Event|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
578956|NCT00940108|B5|Baseline|Total|Total of all reporting groups
578957|NCT00940108|B4|Baseline|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578958|NCT00940108|B3|Baseline|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578959|NCT00940108|B2|Baseline|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579018|NCT00940290|P4|Participant Flow|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
578961|NCT00940108|P4|Participant Flow|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578962|NCT00940108|P3|Participant Flow|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578963|NCT00940108|P2|Participant Flow|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578964|NCT00940108|P1|Participant Flow|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578965|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578966|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578967|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578968|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578969|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578970|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578971|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579038|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
578974|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578975|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578976|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578977|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578978|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578979|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578980|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578981|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578982|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578983|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578984|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578985|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578986|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578987|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578988|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578989|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578990|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578991|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578992|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578993|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578994|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578995|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578996|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578997|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578998|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
578999|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579000|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579001|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579002|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579003|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579004|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579005|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579006|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579007|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579008|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579009|NCT00940108|E4|Reported Event|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579010|NCT00940108|E3|Reported Event|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579011|NCT00940108|E2|Reported Event|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579012|NCT00940108|E1|Reported Event|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
579013|NCT00940290|B5|Baseline|Total|Total of all reporting groups
579014|NCT00940290|B4|Baseline|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
579015|NCT00940290|B3|Baseline|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
579016|NCT00940290|B2|Baseline|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
579017|NCT00940290|B1|Baseline|GRADE System|A clinical recommendation built and graded with the GRADE working group system
579451|NCT00933608|E2|Reported Event|Placebo|
579020|NCT00940290|P2|Participant Flow|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
579021|NCT00940290|P1|Participant Flow|GRADE System|A clinical recommendation built and graded with the GRADE working group system
579022|NCT00940290|O4|Outcome|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
579023|NCT00940290|O3|Outcome|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
579024|NCT00940290|O2|Outcome|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
579025|NCT00940290|O1|Outcome|GRADE System|A clinical recommendation built and graded with the GRADE working group system
579026|NCT00940290|E4|Reported Event|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
579027|NCT00940290|E3|Reported Event|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
579028|NCT00940290|E2|Reported Event|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
579029|NCT00940290|E1|Reported Event|GRADE System|A clinical recommendation built and graded with the GRADE working group system
579030|NCT00940485|B3|Baseline|Total|Total of all reporting groups
579031|NCT00940485|B2|Baseline|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579032|NCT00940485|B1|Baseline|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
579033|NCT00940485|P2|Participant Flow|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579034|NCT00940485|P1|Participant Flow|Peginterferon Alfa-2a + Entecavir|Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks.
579035|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579036|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
579037|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579039|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579040|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
579041|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579042|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
579043|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579044|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
579045|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579046|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
579047|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579048|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
579049|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579050|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
579051|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579052|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
579053|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579054|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
579055|NCT00940485|E2|Reported Event|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
579056|NCT00940485|E1|Reported Event|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
579057|NCT00940537|B3|Baseline|Total|Total of all reporting groups
579058|NCT00940537|B2|Baseline|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
579059|NCT00940537|B1|Baseline|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
579060|NCT00940537|P2|Participant Flow|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
579061|NCT00940537|P1|Participant Flow|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
579062|NCT00940537|O1|Outcome|All Subjects|all subjects studied. This includes both lean and obese subjects with a range of intrahepatic triglyceride.
579063|NCT00940537|O2|Outcome|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
579064|NCT00940537|O1|Outcome|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
579065|NCT00940537|O2|Outcome|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
579066|NCT00940537|O1|Outcome|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
579068|NCT00940537|E1|Reported Event|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
579069|NCT00940576|B1|Baseline|All Study Participants|Oral intake of placebo first, then mare´s milk and oral intake of mare´s milk first, then placebo respectively.
579070|NCT00940576|P2|Participant Flow|Oral Intake of Placebo First, Then Mare´s Milk|Oral intake of 250 ml per day placebo first, then 250 ml per day mare´s milk
579071|NCT00940576|P1|Participant Flow|Oral Intake of Mare´s Milk First, Then Placebo|Oral Intake of 250 ml per day Mare´s Milk First, Then 250 ml per day Placebo
579072|NCT00940576|O2|Outcome|Patients Ulcerative Colitis|
579073|NCT00940576|O1|Outcome|Patients Crohn´s Disease|
579074|NCT00940576|O1|Outcome|Entire Study Population|oral intake of 250 ml mare´s milk or placebo drink daily
579075|NCT00940576|E2|Reported Event|Group 2|oral intake of 250 ml placebo daily
579076|NCT00940576|E1|Reported Event|Group 1|oral intake of 250 ml mare's milk daily
579077|NCT00940875|B3|Baseline|Total|Total of all reporting groups
579078|NCT00940875|B2|Baseline|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
579079|NCT00940875|B1|Baseline|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
579080|NCT00940875|P2|Participant Flow|Gemcitabine (G) Plus (+) Erlotinib (E)|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, orally (PO), once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
579081|NCT00940875|P1|Participant Flow|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
579105|NCT00940901|B1|Baseline|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks
579082|NCT00940875|O2|Outcome|Gemcitabine+ Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
579083|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
579084|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
579085|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
579086|NCT00940875|O2|Outcome|Gemcitabine+ Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
579087|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
579088|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
579089|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
579090|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
579091|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
579092|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
579093|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
579132|NCT00940992|O2|Outcome|Vehicle|"Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks"
579452|NCT00933608|E1|Reported Event|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
579094|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
579095|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
579096|NCT00940875|E2|Reported Event|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
579097|NCT00940875|E1|Reported Event|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
579098|NCT00940888|B1|Baseline|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
579099|NCT00940888|P1|Participant Flow|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
579100|NCT00940888|O1|Outcome|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
579101|NCT00940888|O1|Outcome|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
579102|NCT00940888|E1|Reported Event|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
579103|NCT00940901|B3|Baseline|Total|Total of all reporting groups
579104|NCT00940901|B2|Baseline|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then sildenafil 50 mg for weeks 9-16.
579106|NCT00940901|P2|Participant Flow|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
579107|NCT00940901|P1|Participant Flow|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
579108|NCT00940901|O2|Outcome|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
579109|NCT00940901|O1|Outcome|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
579110|NCT00940901|O2|Outcome|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
579111|NCT00940901|O1|Outcome|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
579112|NCT00940901|E4|Reported Event|Placebo Then Sildenafil Phase 2|Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
579113|NCT00940901|E3|Reported Event|Sildenafil Phase 2|Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
579114|NCT00940901|E2|Reported Event|Placebo Then Sildenafil Phase 1|Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
579115|NCT00940901|E1|Reported Event|Sildenafil Phase 1|Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
579116|NCT00940927|B1|Baseline|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
579117|NCT00940927|P1|Participant Flow|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
579118|NCT00940927|O1|Outcome|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
579119|NCT00940927|O1|Outcome|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
579120|NCT00940927|E1|Reported Event|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
579121|NCT00940992|B4|Baseline|Total|Total of all reporting groups
579122|NCT00940992|B3|Baseline|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks
DER 45 EV: Topical application to face for 12 weeks"
579123|NCT00940992|B2|Baseline|Vehicle|"Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks"
579124|NCT00940992|B1|Baseline|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
DER 45 EV: Topical application to face for 12 weeks"
579125|NCT00940992|P3|Participant Flow|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks
DER 45 EV: Topical application to face for 12 weeks"
579126|NCT00940992|P2|Participant Flow|Vehicle|"Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks"
579127|NCT00940992|P1|Participant Flow|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
DER 45 EV: Topical application to face for 12 weeks"
579128|NCT00940992|O3|Outcome|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks
DER 45 EV: Topical application to face for 12 weeks"
579129|NCT00940992|O2|Outcome|Vehicle|"Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks"
579130|NCT00940992|O1|Outcome|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
DER 45 EV: Topical application to face for 12 weeks"
579131|NCT00940992|O3|Outcome|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks
DER 45 EV: Topical application to face for 12 weeks"
579453|NCT00933686|B3|Baseline|Total|Total of all reporting groups
579133|NCT00940992|O1|Outcome|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
DER 45 EV: Topical application to face for 12 weeks"
579134|NCT00940992|E3|Reported Event|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks
DER 45 EV: Topical application to face for 12 weeks"
579135|NCT00940992|E2|Reported Event|Vehicle|"Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks"
579136|NCT00940992|E1|Reported Event|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
DER 45 EV: Topical application to face for 12 weeks"
579137|NCT00941031|B5|Baseline|Total|Total of all reporting groups
579138|NCT00941031|B4|Baseline|Placebo|
579139|NCT00941031|B3|Baseline|Induction Early Loading Dose|
579140|NCT00941031|B2|Baseline|Induction Monthly Dose|
579141|NCT00941031|B1|Baseline|Induction Single Dose|Baseline through Week 12
579142|NCT00941031|P7|Participant Flow|Open Label|"Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - OL: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29"
579143|NCT00941031|P6|Participant Flow|Start of Relapse|"Treatment at start of relapse regimen - SR: Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
579144|NCT00941031|P5|Participant Flow|Fixed Interval|"Fixed-time interval regimen - FI: secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
579145|NCT00941031|P4|Participant Flow|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
579146|NCT00941031|P3|Participant Flow|Induction Early Loading|"Early loading induction - Early: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12"
579147|NCT00941031|P2|Participant Flow|Induction Monthly Dose|"Induction with monthly injections - Monthly: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12"
579148|NCT00941031|P1|Participant Flow|Induction Single Dose|"Induction with single injection - Single: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12"
579149|NCT00941031|O4|Outcome|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
579416|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579150|NCT00941031|O3|Outcome|Induction Early Loading Dose|Early loading induction – “Early”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
579151|NCT00941031|O2|Outcome|Induction Monthly Dose|Induction with monthly injections – “Monthly”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
579152|NCT00941031|O1|Outcome|Induction Single Dose|Induction with single injection – “Single”: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
579153|NCT00941031|O3|Outcome|Maintenance Open Label|Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase – “OL”: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29
579154|NCT00941031|O2|Outcome|Maintenance Start of Relapse|Treatment at start of relapse regimen – “SR”: Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
579155|NCT00941031|O1|Outcome|Maintenance Fixed Interval|Fixed-time interval regimen – “FI”: secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
579156|NCT00941031|O4|Outcome|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
579157|NCT00941031|O3|Outcome|Induction Early Loading Dose|Early loading induction – “Early”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
579158|NCT00941031|O2|Outcome|Induction Monthly Dose|Induction with monthly injections – “Monthly”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
579159|NCT00941031|O1|Outcome|Induction Single Dose|Induction with single injection – “Single”: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
579160|NCT00941031|E10|Reported Event|FOLLOW-UP: Open Label|FOLLOW-UP: Open label
579161|NCT00941031|E9|Reported Event|FOLLOW-UP: Start of Relapse|FOLLOW-UP: Treatment at start of relapse regimen - 'SR'
579162|NCT00941031|E8|Reported Event|FOLLOW-UP: Fixed Interval|FOLLOW-UP: Fixed-time interval regimen - 'FI'
579163|NCT00941031|E7|Reported Event|MAINTENANCE: Open Label|MAINTENANCE: Open label Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase – “OL”: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.
579164|NCT00941031|E6|Reported Event|MAINTENANCE: Start of Relapse|MAINTENANCE: Treatment at start of relapse regimen - 'SR'
579165|NCT00941031|E5|Reported Event|MAINTENANCE: Fixed Interval|MAINTENANCE: Fixed-time interval regimen - 'FI'
579166|NCT00941031|E4|Reported Event|INDUCTION: Placebo|INDUCTION: Placebo - 'Placebo'
579167|NCT00941031|E3|Reported Event|INDUCTION: Early|INDUCTION: with single injection - 'Single'
579168|NCT00941031|E2|Reported Event|INDUCTION: Monthly|INDUCTION: with monthly injections - 'Monthly'
579169|NCT00941031|E1|Reported Event|INDUCTION: Single|INDUCTION: Early loading induction - 'Early'
579192|NCT00933244|P3|Participant Flow|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579493|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection|Specimens collected from a population of apparently healthy individuals at low risk for HIV infection.
579170|NCT00941070|B1|Baseline|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579171|NCT00941070|P1|Participant Flow|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579172|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579173|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579200|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579174|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579175|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579176|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579177|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579193|NCT00933244|P2|Participant Flow|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
580347|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
579178|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579179|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579180|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579181|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579182|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579201|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579183|NCT00941070|E1|Reported Event|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
579184|NCT00933166|B1|Baseline|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
579185|NCT00933166|P1|Participant Flow|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
579186|NCT00933166|O1|Outcome|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
579187|NCT00933166|E1|Reported Event|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
579188|NCT00933244|B4|Baseline|Total|Total of all reporting groups
579189|NCT00933244|B3|Baseline|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579190|NCT00933244|B2|Baseline|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
579191|NCT00933244|B1|Baseline|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
580348|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
579194|NCT00933244|P1|Participant Flow|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579195|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579196|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
579197|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579198|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579199|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
579378|NCT00933491|P1|Participant Flow|Diabetic|Type II Diabetes
579379|NCT00933491|O2|Outcome|Control|Non-diabetics
579202|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
579203|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579204|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579205|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
579206|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579207|NCT00933244|E3|Reported Event|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579208|NCT00933244|E2|Reported Event|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
579355|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579209|NCT00933244|E1|Reported Event|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
579210|NCT00933270|B1|Baseline|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579211|NCT00933270|P1|Participant Flow|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579212|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579213|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579214|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579215|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579216|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579217|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579218|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579219|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579380|NCT00933491|O1|Outcome|Diabetic|Type II Diabetes
579381|NCT00933491|O2|Outcome|Control|Non-diabetics
579220|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579221|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579222|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579223|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579224|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579225|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579226|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579227|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579228|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579229|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579230|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579231|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579232|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579233|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579234|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579235|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579236|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579237|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579238|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579239|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579240|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579241|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579242|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579243|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579244|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579382|NCT00933491|O1|Outcome|Diabetic|Type II Diabetes
579383|NCT00933491|E2|Reported Event|Control|Non-diabetics
579384|NCT00933491|E1|Reported Event|Diabetic|Type II Diabetes
579245|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579246|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579247|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579248|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579249|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579250|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579251|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579252|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579253|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579254|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579255|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579256|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579257|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579258|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579259|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579260|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579261|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579262|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579263|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579264|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579265|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579266|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579267|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579268|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579269|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579385|NCT00933543|B3|Baseline|Total|Total of all reporting groups
579386|NCT00933543|B2|Baseline|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579270|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579271|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579272|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579273|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579274|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579275|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579276|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579277|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579278|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579279|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579280|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579281|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579282|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579283|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579284|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579285|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579286|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579287|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579288|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579289|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579290|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579291|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579292|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579293|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579294|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579387|NCT00933543|B1|Baseline|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579388|NCT00933543|P2|Participant Flow|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579295|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579296|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579297|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579298|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System
Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
579299|NCT00933270|E2|Reported Event|Supera® Peripheral Stent System Roll-in|"Implantation of Supera stent using the Supera® Peripheral Stent System.
There were a total of 61 roll-in subjects."
579300|NCT00933270|E1|Reported Event|Supera® Peripheral Stent System ITT|"Implantation of Supera stent using the Supera® Peripheral Stent System.
ITT population consisted of 264 subjects."
579301|NCT00933335|B3|Baseline|Total|Total of all reporting groups
579302|NCT00933335|B2|Baseline|Fludarabine (3 Cycles); TST and Iodine I 131 TST|Participants (par.) received 3 cycles of IV fludarabine (FL) monophosphate (25 mg/m^2/day) for 5 days every 5-6 weeks. After receiving FL, par. meeting criteria received the dosimetric dose (DD), administered 6-8 weeks after the 3rd cycle of FL. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Par. received >=3 doses (4 drops by mouth [DBM], 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 DBM, TID) of Lugol’s solution, or KI tablets (130 mg BM, once a day) >=24 hrs prior to administration of the DD and continued daily for 14 days after the therapeutic dose (TD), administered 7-14 days after the DD. The TD was an IV infusion of 450 mg TST over 1 hr, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579303|NCT00933335|B1|Baseline|Received Less Than 3 Cycles of Fludarabine|Participants received less than 3 cycles of intravenous (IV) fludarabine monophosphate (25 milligrams/meter^2/day [mg/m^2/day]) for 5 days every 5 to 6 weeks.
579434|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579435|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579436|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579437|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579438|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579439|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579440|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579304|NCT00933335|P2|Participant Flow|Fludarabine (3 Cycles); TST and Iodine I 131 TST|Participants (par.) received 3 cycles of IV fludarabine (FL) monophosphate (25 mg/m^2/day) for 5 days every 5-6 weeks. After receiving FL, par. meeting criteria received the dosimetric dose (DD), administered 6-8 weeks after the 3rd cycle of FL. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Par. received >=3 doses (4 drops by mouth [DBM], 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 DBM, TID) of Lugol’s solution, or KI tablets (130 mg BM, once a day) >=24 hrs prior to administration of the DD and continued daily for 14 days after the therapeutic dose (TD), administered 7-14 days after the DD. The TD was an IV infusion of 450 mg TST over 1 hr, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579305|NCT00933335|P1|Participant Flow|Received Less Than 3 Cycles of Fludarabine|Participants received less than 3 cycles of intravenous (IV) fludarabine monophosphate (25 milligrams/meter^2/day [mg/m^2/day]) for 5 days every 5 to 6 weeks.
579306|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579307|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579308|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579389|NCT00933543|P1|Participant Flow|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579390|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579391|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579392|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579393|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579309|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579310|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579311|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579441|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579312|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579313|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579314|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579315|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579316|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579394|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579317|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579318|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579319|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579320|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579321|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579322|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579323|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579324|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579325|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579326|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579327|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579328|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579329|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579442|NCT00933543|E2|Reported Event|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579443|NCT00933543|E1|Reported Event|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579444|NCT00933608|B3|Baseline|Total|Total of all reporting groups
579445|NCT00933608|B2|Baseline|Placebo|
579446|NCT00933608|B1|Baseline|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
579330|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579331|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579332|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579333|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579334|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579335|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579395|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579396|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579397|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579398|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579399|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579336|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579337|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579447|NCT00933608|P2|Participant Flow|Placebo|participants were taking 1 tablet twice a day to match memantine arm
579448|NCT00933608|P1|Participant Flow|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
579449|NCT00933608|O2|Outcome|Placebo|participant will be taking 1 tablet twice a day to match active arm
579338|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579339|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579340|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579341|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579342|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579343|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579400|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579401|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579344|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579345|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579346|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579347|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579348|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579349|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579350|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579351|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579352|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579402|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579403|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579404|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579405|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579406|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579407|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579353|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579354|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579356|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579357|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579358|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579359|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579360|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579361|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579362|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579408|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579409|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579410|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579411|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
581167|NCT00943852|O1|Outcome|Losartan 100 mg + ISMN 60 mg|
579363|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579364|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579365|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579366|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579367|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579368|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579369|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579370|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
579371|NCT00933335|E3|Reported Event|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
579372|NCT00933335|E2|Reported Event|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
579373|NCT00933335|E1|Reported Event|Fludarabine|Participants who received any number of cycles of IV fludarabine monophosphate (25 mg/m^2/day). Each cycle was administered for 5 days every 5 to 6 weeks.
579374|NCT00933491|B3|Baseline|Total|Total of all reporting groups
579375|NCT00933491|B2|Baseline|Control|Non-diabetics
579376|NCT00933491|B1|Baseline|Diabetic|Type II Diabetes
579377|NCT00933491|P2|Participant Flow|Control|Non-diabetics
579417|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579418|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579419|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579420|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579421|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579422|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579423|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579424|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579425|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579426|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579427|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579428|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579429|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579430|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579431|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579432|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
579433|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
579454|NCT00933686|B2|Baseline|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
579455|NCT00933686|B1|Baseline|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
579456|NCT00933686|P2|Participant Flow|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
579457|NCT00933686|P1|Participant Flow|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
579458|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
579459|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
579460|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
579461|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
579538|NCT00934128|E1|Reported Event|Group1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) air delivery then Vapotherm device air delivery.
579462|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
579463|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
579464|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
579465|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
579466|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
579467|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
579468|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
579469|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
579470|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
579471|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
579494|NCT00933933|E3|Reported Event|Architect HIV Ag/Ab Combo Reactivity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
579759|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
579472|NCT00933686|E2|Reported Event|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
579473|NCT00933686|E1|Reported Event|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
579474|NCT00933933|B6|Baseline|Total|Total of all reporting groups
579475|NCT00933933|B5|Baseline|Architect HIV Ag/Ab Combo Reactivity|Specimens collected from individuals at increased risk for HIV infection under a separate specimen collection protocol (pregant females 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
579476|NCT00933933|B4|Baseline|Architect HIV Ag/Ab Combo HIV-2 Antibody Sensitivity|Specimens obtained from specimen vendors were tested with investigational HIV test.
579477|NCT00933933|B3|Baseline|Architect Ag/Ab Combo HIV-1 Antibody Sensitivity|Specimens collected from HIV-1 infected individuals under a separate specimen collection protocol (pediatric subjects 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
579478|NCT00933933|B2|Baseline|Architect HIV Ag/Ab Combo HIV-1 Antigen Sensitivity|Specimens obtained from specimen vendors were tested with investigational HIV test.
579479|NCT00933933|B1|Baseline|Architect HIV Ag/Ab Combo Specificity|Specimens collected from apparently healthy individuals under a separate specimen collection protocol (7B5-02-05Z01-01) or obtained from specimen vendors and were tested with investigational HIV test.
579480|NCT00933933|P3|Participant Flow|Architect HIV Ag/Ab Combo Reactivity|"Reactivty populations included:
1206 specimens collected from individuals at increased risk for HIV infection (16-89 years of age) from US and Cote D'Ivoire.
203 specimen from pregnant females at risk for HIV infection.
Of these 1409 specimens, 61 were collected from individual that were from 16 up to 21 years of age.
Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test."
579481|NCT00933933|P2|Participant Flow|Architect HIV Ag/Ab Combo Sensitivity|"Sensitivity populations included:
1287 specimens or commercial panel members HIV-1 p24 Antigen positive, specimens confirmed HIV-1 antibody positive and specimens confirmed HIV-2 antibody positive.
67 specimens from pregnant females from all three trimesters confirmed HIV posiitve by supplemental testing.
64 specimens from pediatric subjects confirmed HIV positive by supplemental testing (2 to 21 years of age).
Specimens were collected under separate collection protocols or by specimens vendors and tested with investigational HIV test."
579505|NCT00934050|P5|Participant Flow|Placebo/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
579482|NCT00933933|P1|Participant Flow|Architect HIV Ag/Ab Combo Specificity|"Specificity populations included:
6164 specimens collected from apparently healthy individuals at low risk for HIV infection (16-89 years of age) which includes 250 specimens from pregnant females in first trimester of pregnancy.
448 specimen from presumed HIV negative pregnant females from 16 to 44 years of age.
588 specimen from pediatric presumed negative for HIV from 2 to 21 years of age.
Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test."
579483|NCT00933933|O3|Outcome|Reactivity in Pregnant Female Population|Specimens collected from 203 pregnant females: 153 specimens collected from pregnant females with documented risk factors for HIV and 50 were surplus serum specimens collected pregnant females from a health clinic offering HIV testing. Spcimens from 55 of the pregnant females with risk for HIV infection were collected under a specimen collection protocol and tested with the investigational and FDA-licensed comparator assay during the study. The remaining specimens were obtained from specimen vendors and tested with the investigational HIV test.
579484|NCT00933933|O2|Outcome|Increased Risk for HIV From HIV-2 Endemic Area|Specimens from 513 individuals documented as being at risk for acquiring HIV that reside in an HIV-2 endemic area (Cote De'Ivoire) having one or more of the following risk factors: unprotected sex with someone who is infected with HIV, multiple sex partners, men who have sex with men, users of injecting drugs. Specimens were obtained from specimen vendors and tested with investigational HIV test.
579485|NCT00933933|O1|Outcome|Increased Risk for HIV in US Population|Specimens collected from 693 individuals in the US population documented as having one or more of the following risk factors: users of injecting drugs, unprotected sex with someone who is infected with HIV, diagnosed or treated for a sexually transmitted disease (STD), hepatitis or tuberculosis, multiple sex partners, men who have sex with men, men who have sex with men and are users of injecting drugs, unprotected sex with someone who has been diagnosed or treated for an STD, risk factor not identified but requested an HIV test. Specimens obtained from specimen vendors and were tested with investigational HIV test.
579486|NCT00933933|O2|Outcome|Architect HIV Ag/Ab Combo Sensitivity in Pediatric Population|Specimens confirmed HIV positive by HIV-1 Western blot were tested with investigational HIV test. Specimens from individuals between 2 and 21 years of age.
579487|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Combo Specificity in Pediatric Population|Specimens presumed HIV negative tested with investigational HIV test, FDA-licensed comparator assay and supplemental tests. Specimens from individuals between 2 and 21 years of age.
579488|NCT00933933|O2|Outcome|Architect HIV Ag/Ab Combo Sensitivity in Pregnant Females|HIV confirmed positive specimens from pregnant females tested with investigation HIV test, comparator assay and supplement tests.
579489|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Combo Specificity in Pregnant Females|HIV presumed negative specimens from pregnant females tested with investigation HIV test, comparator assay and supplemental tests.
579490|NCT00933933|O3|Outcome|HIV-2 Antibody Sensitivity|Specimens collected from HIV infected individuals in Ivory Coast confirmed by HIV-2 Western blot.
579491|NCT00933933|O2|Outcome|HIV-1 Antibody Sensitivity|Specimens collected from HIV infected individuals in US population confirmed by HIV-1 Western blot.
579492|NCT00933933|O1|Outcome|HIV p24 Antgen Sensitivity|HIV-1 Antigen positive specimens/commercial panel members (HIV Westerm blot negative and confirmed positive by HIV-1 p24 Antigen and/or HIV RNA) and HIV-1 viral isolates.
579495|NCT00933933|E2|Reported Event|Architect HIV Ag/Ab Combo Sensitivity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
579496|NCT00933933|E1|Reported Event|Architect HIV Ag/Ab Combo Specificity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
579497|NCT00934050|B7|Baseline|Total|Total of all reporting groups
579498|NCT00934050|B6|Baseline|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
579499|NCT00934050|B5|Baseline|Placebo/ELND005 250mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
579500|NCT00934050|B4|Baseline|2000mg BID/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND05 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579501|NCT00934050|B3|Baseline|1000mg BID/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579502|NCT00934050|B2|Baseline|250mg BID/2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579503|NCT00934050|B1|Baseline|Placebo/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579504|NCT00934050|P6|Participant Flow|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
579537|NCT00934128|E2|Reported Event|Group 2: Vapotherm Then BiPAP|Vapotherm device air delivery then Bilevel positive airway pressure device (BiPAP) air delivery.
579506|NCT00934050|P4|Participant Flow|2000 mg ELND005/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579507|NCT00934050|P3|Participant Flow|1000 mg/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579508|NCT00934050|P2|Participant Flow|250mg/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579509|NCT00934050|P1|Participant Flow|Placebo/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579510|NCT00934050|O2|Outcome|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
579511|NCT00934050|O1|Outcome|Placebo/ELND005 250mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
579512|NCT00934050|E6|Reported Event|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
579513|NCT00934050|E5|Reported Event|Placebo/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
579514|NCT00934050|E4|Reported Event|2000 mg ELND005/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579515|NCT00934050|E3|Reported Event|1000 mg/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579516|NCT00934050|E2|Reported Event|250mg/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579517|NCT00934050|E1|Reported Event|Placebo/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
579518|NCT00934102|B1|Baseline|Overall|This reporting group includes all subjects who were screened for the study, whether or not they subsequently were dispensed.
579519|NCT00934102|P3|Participant Flow|Lotrafilcon A / Galyfilcon A|Lotrafilcon A commercial contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
579520|NCT00934102|P2|Participant Flow|Narafilcon A / Galyfilcon A|Narafilcon A experimental contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
579521|NCT00934102|P1|Participant Flow|Narafilcon A / Lotrafilcon A|Narafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
579522|NCT00934102|O3|Outcome|Galyfilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
579523|NCT00934102|O2|Outcome|Narafilcon A|Investigational, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
579524|NCT00934102|O1|Outcome|Lotrafilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
579525|NCT00934102|E3|Reported Event|Galyfilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
579526|NCT00934102|E2|Reported Event|Narafilcon A|Experimental, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
579527|NCT00934102|E1|Reported Event|Lotrafilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
579528|NCT00934128|B3|Baseline|Total|Total of all reporting groups
579529|NCT00934128|B2|Baseline|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
579530|NCT00934128|B1|Baseline|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
579531|NCT00934128|P2|Participant Flow|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
579532|NCT00934128|P1|Participant Flow|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then high flow oxygen (HFO) delivery using Vapotherm device.
579533|NCT00934128|O2|Outcome|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
579534|NCT00934128|O1|Outcome|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
579535|NCT00934128|O2|Outcome|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
579536|NCT00934128|O1|Outcome|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
579539|NCT00934141|B5|Baseline|Total|Total of all reporting groups
579540|NCT00934141|B4|Baseline|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
579541|NCT00934141|B3|Baseline|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
579542|NCT00934141|B2|Baseline|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
579543|NCT00934141|B1|Baseline|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
579544|NCT00934141|P4|Participant Flow|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
579545|NCT00934141|P3|Participant Flow|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
579546|NCT00934141|P2|Participant Flow|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
579547|NCT00934141|P1|Participant Flow|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
579548|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
579549|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
579550|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
579551|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
579552|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
579553|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
579554|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
579555|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
579556|NCT00934141|O4|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
579557|NCT00934141|O3|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
579558|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
579559|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
579560|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
579561|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
579562|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
579563|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
579564|NCT00934141|E4|Reported Event|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
579565|NCT00934141|E3|Reported Event|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
579760|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
579566|NCT00934141|E2|Reported Event|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
579567|NCT00934141|E1|Reported Event|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
579568|NCT00934180|B3|Baseline|Total|Total of all reporting groups
579569|NCT00934180|B2|Baseline|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg OD Tablet (test) dosed in second period
579570|NCT00934180|B1|Baseline|Ondansetron (Test) First|Ondansetron HCl 8 mg OD Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
579571|NCT00934180|P2|Participant Flow|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg OD Tablet (test) dosed in second period
579572|NCT00934180|P1|Participant Flow|Ondansetron (Test) First|Ondansetron HCl 8 mg OD Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
579573|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
579574|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
579575|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
579576|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
579577|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
579578|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
579579|NCT00934362|B3|Baseline|Total|Total of all reporting groups
579580|NCT00934362|B2|Baseline|Placebo First, Then Lucinactant|0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
579581|NCT00934362|B1|Baseline|Lucinactant First, Then Placebo|20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
579582|NCT00934362|P2|Participant Flow|Placebo First, Then Lucinactant|0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
579583|NCT00934362|P1|Participant Flow|Lucinactant First, Then Placebo|20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
579584|NCT00934362|O2|Outcome|Placebo|0.9% NaCl x 6 ml (5 doses)
579585|NCT00934362|O1|Outcome|Lucinactant|20 mg/ml x 6 ml lucinactant (5 doses)
579586|NCT00934362|O2|Outcome|Placebo|0.9% NaCl x 6 ml (5 doses)
579587|NCT00934362|O1|Outcome|Lucinactant|20 mg/ml x 6 ml lucinactant (5 doses)
579588|NCT00934362|E2|Reported Event|Placebo|0.9% NaCl x 6 ml (5 doses)
579589|NCT00934362|E1|Reported Event|Lucinactant|20 mg/ml x 6 ml (5 doses)
579590|NCT00934375|B3|Baseline|Total|Total of all reporting groups
579591|NCT00934375|B2|Baseline|Placebo|
579592|NCT00934375|B1|Baseline|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
579593|NCT00934375|P2|Participant Flow|Placebo|
579594|NCT00934375|P1|Participant Flow|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
579595|NCT00934375|O2|Outcome|Placebo|
579596|NCT00934375|O1|Outcome|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
579597|NCT00934375|E2|Reported Event|Placebo|
579598|NCT00934375|E1|Reported Event|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
579599|NCT00934440|B1|Baseline|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
579600|NCT00934440|P1|Participant Flow|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
579601|NCT00934440|O1|Outcome|Dose Escalation: 5-azacitidine|"A traditional 3+3 dose escalation trial was implemented. Successive cohorts of patients (3 participants/cohort) received bevacizumab at the standard dose of 10mg/kg in combination with escalating doses of 5-azacitidine. If no dose limiting toxicity (DLT) is seen, subsequent patients will be treated at the next dose level. If one DLT is seen, an additional three patients will be accrued at that dose level. If two or more DLTs are seen at one dose level, then the previous dose level will be chosen for phase IIA. If two DLT’s are seen at dose level 1, the trial will end. The standard 5-azacitidine dose is 75mg/m2/day for 7 days. If no DLT is seen at dose level 3, then we will proceed with the phase IIA portion of the study.
Bevacizumab:
First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1
Second treatment: 10 MG/KG IV on Day 1
Third and subsequent treatments: 10 MG/KG IV on Day 1"
579602|NCT00934440|O1|Outcome|5-Azacitidine Maximum Tolerated Dose (MTD)|
579603|NCT00934440|E1|Reported Event|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
579604|NCT00934544|B3|Baseline|Total|Total of all reporting groups
580349|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
579605|NCT00934544|B2|Baseline|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
579606|NCT00934544|B1|Baseline|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
579607|NCT00934544|P2|Participant Flow|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
579608|NCT00934544|P1|Participant Flow|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
579609|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, or no therapy, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) was used.
579610|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg twice daily (BID) or 20 mg BID were selected with starting dose based on baseline platelet count. Starting dose was either 15 mg BID or 20 mg BID based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
579611|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
579612|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
579613|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
579614|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
579615|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
579616|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
579617|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
579618|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
579619|NCT00934544|E2|Reported Event|Best Available Therapy (BAT)|Best Available Therapy (BAT) was prescribed at doses and schedules selected by the Investigator on a subject-by-subject basis. BAT could include a single agent, combination of agents for the treatment of the disease and its symptoms or no therapy. Therapy could be changed at any time during the study EXCEPT during the screening period. No experimental drugs were permitted during the study.
579620|NCT00934544|E1|Reported Event|INC424/INCB018424|"The starting dose of ruxolitinib tablets was determined based on baseline platelet count as follows: Subjects with baseline platelet count > 200, 000/µL began dosing at 20 mg bid (four 5 mg tablets bid) or Subjects with baseline platelet count of 100,000/µL to 200,000/µL (inclusive) began dosing at 15 mg bid (three 5 mg tablets bid).
A standardized dosing paradigm was used to determine dose adjustments for safety and efficacy so that each subject was titrated to their most appropriate dose."
579621|NCT00934596|B3|Baseline|Total|Total of all reporting groups
579693|NCT00934635|E1|Reported Event|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
579694|NCT00934648|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
579622|NCT00934596|B2|Baseline|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before cannulation, CO2 was insufflated in the mediastinum at a flow rate of 10 litres/minute and continued until 10 minutes post-CPB. After completed surgery, the heart and lungs were passively re-filled with blood and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under transesophageal echocardiographic (TEE) monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to eject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579623|NCT00934596|B1|Baseline|Lund De-airing Technique|Before cardiopulmonary bypass (CPB) was established, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. Hereafter the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart defibrillated. After a good cardiac contraction and normal central hemodynamics were established, the LV preload was gradually and successively increased. When no air emboli were observed in the left side of the heart by transesophageal echocardiography (TEE), the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579624|NCT00934596|P2|Participant Flow|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the carbon-dioxide(CO2) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completed surgery, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579639|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579625|NCT00934596|P1|Participant Flow|Lund De-airing Technique|Before cardiopulmonary bypass (CPB) was established, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart by Trans-esophageal Echocardiography (TEE), the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579626|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579627|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579695|NCT00934648|P1|Participant Flow|Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg administered intravenously (IV) and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background methotrexate (MTX) 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
579696|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
579628|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579629|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579630|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579631|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579668|NCT00934635|P8|Participant Flow|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
579669|NCT00934635|P7|Participant Flow|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
579670|NCT00934635|P6|Participant Flow|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
579788|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579632|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
579633|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579634|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579635|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579636|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579637|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579638|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579671|NCT00934635|P5|Participant Flow|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
579672|NCT00934635|P4|Participant Flow|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
579673|NCT00934635|P3|Participant Flow|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
579674|NCT00934635|P2|Participant Flow|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
579640|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579641|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579642|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
579643|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579644|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579645|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579646|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579675|NCT00934635|P1|Participant Flow|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
579676|NCT00934635|O9|Outcome|Control|PET Scan Control
579677|NCT00934635|O8|Outcome|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
579678|NCT00934635|O7|Outcome|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
579843|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
579647|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579648|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
579649|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579650|NCT00934596|E2|Reported Event|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
579651|NCT00934596|E1|Reported Event|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
579652|NCT00934622|B1|Baseline|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
579653|NCT00934622|P1|Participant Flow|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
579654|NCT00934622|O1|Outcome|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
579655|NCT00934622|O1|Outcome|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
579656|NCT00934622|E1|Reported Event|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
579657|NCT00934635|B10|Baseline|Total|Total of all reporting groups
579658|NCT00934635|B9|Baseline|Control|PET Scan Control
579659|NCT00934635|B8|Baseline|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
579660|NCT00934635|B7|Baseline|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
579661|NCT00934635|B6|Baseline|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
579662|NCT00934635|B5|Baseline|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
579663|NCT00934635|B4|Baseline|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
579664|NCT00934635|B3|Baseline|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
579665|NCT00934635|B2|Baseline|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
579666|NCT00934635|B1|Baseline|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
579667|NCT00934635|P9|Participant Flow|Control|PET Scan Control
579786|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579679|NCT00934635|O6|Outcome|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
579680|NCT00934635|O5|Outcome|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
579681|NCT00934635|O4|Outcome|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
579682|NCT00934635|O3|Outcome|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
579683|NCT00934635|O2|Outcome|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
579684|NCT00934635|O1|Outcome|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
579685|NCT00934635|E9|Reported Event|Control|PET Scan Control
579686|NCT00934635|E8|Reported Event|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
579687|NCT00934635|E7|Reported Event|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
579688|NCT00934635|E6|Reported Event|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
579689|NCT00934635|E5|Reported Event|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
579690|NCT00934635|E4|Reported Event|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
579691|NCT00934635|E3|Reported Event|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
579692|NCT00934635|E2|Reported Event|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
580350|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
579697|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
579698|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
579699|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
579700|NCT00934648|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
579701|NCT00934791|B3|Baseline|Total|Total of all reporting groups
579702|NCT00934791|B2|Baseline|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
579703|NCT00934791|B1|Baseline|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
579704|NCT00934791|P2|Participant Flow|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
579705|NCT00934791|P1|Participant Flow|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
579706|NCT00934791|O2|Outcome|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
579707|NCT00934791|O1|Outcome|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
579708|NCT00934791|E2|Reported Event|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
579709|NCT00934791|E1|Reported Event|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
579710|NCT00934843|B3|Baseline|Total|Total of all reporting groups
579711|NCT00934843|B2|Baseline|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
579712|NCT00934843|B1|Baseline|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
579713|NCT00934843|P2|Participant Flow|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
579714|NCT00934843|P1|Participant Flow|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
579715|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
579716|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
579717|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
579718|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
579719|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
579720|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
579721|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
579722|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
579723|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
579724|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
579725|NCT00934843|E2|Reported Event|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
579726|NCT00934843|E1|Reported Event|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
579727|NCT00934856|B7|Baseline|Total|Total of all reporting groups
579728|NCT00934856|B6|Baseline|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579729|NCT00934856|B5|Baseline|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579757|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
579758|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
580351|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
579730|NCT00934856|B4|Baseline|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579731|NCT00934856|B3|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579732|NCT00934856|B2|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579733|NCT00934856|B1|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579734|NCT00934856|P6|Participant Flow|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579735|NCT00934856|P5|Participant Flow|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579736|NCT00934856|P4|Participant Flow|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579737|NCT00934856|P3|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579787|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579738|NCT00934856|P2|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579739|NCT00934856|P1|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with human epidermal growth factor receptor 2 (HER2)-positive MBC received docetaxel (Doc) 75 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 and trastuzumab emtansine (T-DM1) 2.4 milligrams per kilogram (mg/kg) IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579740|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
579741|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
579742|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
579743|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
579744|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
579745|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
579746|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
579747|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
579748|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
579749|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
579750|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
579751|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
579752|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
579753|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
579754|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
579755|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
579756|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
579761|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
579762|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
579763|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
579764|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
579765|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579766|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579767|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579768|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579769|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579770|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579771|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579772|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579773|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579774|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579775|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579776|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579777|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579778|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579779|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579780|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579781|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579782|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579783|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579784|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579785|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579789|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579790|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579791|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579792|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579793|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579794|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579795|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579796|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579797|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579798|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579799|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579800|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579801|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
579802|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
579803|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
579804|NCT00934856|O1|Outcome|Overall MBC and LABC Participants|All enrolled participants who received at least one dose of study medication
579805|NCT00934856|O2|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579806|NCT00934856|O1|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579807|NCT00934856|O2|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579808|NCT00934856|O1|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579809|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
579810|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
582785|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
579811|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
579812|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
579813|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
579814|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
579815|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
579816|NCT00934856|O6|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579817|NCT00934856|O5|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579818|NCT00934856|O4|Outcome|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579819|NCT00934856|O3|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579820|NCT00934856|O2|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579844|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
579845|NCT00934947|B3|Baseline|Total|Total of all reporting groups
579821|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579822|NCT00934856|O6|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579823|NCT00934856|O5|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579824|NCT00934856|O4|Outcome|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579825|NCT00934856|O3|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579826|NCT00934856|O2|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579827|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579828|NCT00934856|E6|Reported Event|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579829|NCT00934856|E5|Reported Event|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
579920|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579830|NCT00934856|E4|Reported Event|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579831|NCT00934856|E3|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579832|NCT00934856|E2|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579833|NCT00934856|E1|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
579834|NCT00934921|B3|Baseline|Total|Total of all reporting groups
579835|NCT00934921|B2|Baseline|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
579836|NCT00934921|B1|Baseline|Ondansetron (Test) First|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
579837|NCT00934921|P2|Participant Flow|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
579838|NCT00934921|P1|Participant Flow|Ondansetron (Test) First|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
579839|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
579840|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
579841|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
579842|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
579846|NCT00934947|B2|Baseline|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
579847|NCT00934947|B1|Baseline|Sugar Pill|Identical to active drug in sight, taste, and smell.
579848|NCT00934947|P2|Participant Flow|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
579849|NCT00934947|P1|Participant Flow|Sugar Pill|Identical to active drug in sight, taste, and smell.
579850|NCT00934947|O2|Outcome|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
579851|NCT00934947|O1|Outcome|Sugar Pill|Identical to active drug in sight, taste, and smell.
579852|NCT00934947|E2|Reported Event|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
579853|NCT00934947|E1|Reported Event|Sugar Pill|Identical to active drug in sight, taste, and smell.
579854|NCT00935064|B3|Baseline|Total|Total of all reporting groups
579855|NCT00935064|B2|Baseline|Placebo|Once daily, for 6 weeks
579856|NCT00935064|B1|Baseline|Aliskiren|300 mg, once daily, for 6 weeks
579857|NCT00935064|P2|Participant Flow|Placebo|Once daily, for 6 weeks
579858|NCT00935064|P1|Participant Flow|Aliskiren|300 mg, once daily, for 6 weeks
579859|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
579860|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
579861|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
579862|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
579863|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
579864|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
579865|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
579866|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
579867|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
579868|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
579869|NCT00935064|E2|Reported Event|Placebo|Once daily, for 6 weeks
579870|NCT00935064|E1|Reported Event|Aliskiren|300 mg, once daily, for 6 weeks
579871|NCT00935220|B1|Baseline|Linagliptin 5mg|Linagliptin 5mg once daily
579872|NCT00935220|P1|Participant Flow|Linagliptin 5mg|Linagliptin 5mg once daily
579873|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
579874|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
579875|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
579876|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
579877|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
579878|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
579879|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
579880|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
579881|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
579882|NCT00935220|E1|Reported Event|Linagliptin 5mg|Linagliptin 5mg once daily
579883|NCT00935259|B1|Baseline|All Participants|All enrolled participants
579884|NCT00935259|P2|Participant Flow|Placebo First, Then Simvastatin 40 mg|Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks
579977|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579885|NCT00935259|P1|Participant Flow|Simvastatin 40 mg, Then Placebo|Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks
579886|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
579887|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
579888|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
579889|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
579890|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
579891|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
579892|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
579893|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
579894|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks
579895|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks
579896|NCT00935259|E2|Reported Event|Placebo|Placebo to simvastatin tablets once daily for 2 weeks in either Period 1 or Period 2
579897|NCT00935259|E1|Reported Event|Simvastatin|Simvastatin 40 mg tablets once daily for 2 weeks in either Period 1 or Period 2
579898|NCT00935272|B3|Baseline|Total|Total of all reporting groups
579899|NCT00935272|B2|Baseline|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
579900|NCT00935272|B1|Baseline|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
579901|NCT00935272|P2|Participant Flow|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
579902|NCT00935272|P1|Participant Flow|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
579903|NCT00935272|O2|Outcome|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
579944|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
579945|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
579904|NCT00935272|O1|Outcome|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
579905|NCT00935272|O2|Outcome|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
579906|NCT00935272|O1|Outcome|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
579907|NCT00935272|E3|Reported Event|Second Treatment|At Week 24, subjects who were initially randomized to treatment were offered an optional second treatment with Restylane. In addition those randomized to non-treatment were offered their first treatment of Restylane at week 24. The safety from this set was followed to one month after the treatment.
579908|NCT00935272|E2|Reported Event|No Treatment|Safety included post treatment assessment, and assessments at each visit throughout the study.
579909|NCT00935272|E1|Reported Event|Treatment With Restylane|Safety included post treatment assessment, and assessments at each visit throughout the study.
579910|NCT00935311|B4|Baseline|Total|Total of all reporting groups
579911|NCT00935311|B3|Baseline|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579912|NCT00935311|B2|Baseline|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
579913|NCT00935311|B1|Baseline|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579914|NCT00935311|P3|Participant Flow|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579915|NCT00935311|P2|Participant Flow|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
579916|NCT00935311|P1|Participant Flow|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579917|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579918|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
579919|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
580054|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
579921|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
579922|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579923|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579924|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
579925|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579926|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579927|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
579928|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579929|NCT00935311|E3|Reported Event|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579930|NCT00935311|E2|Reported Event|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
579931|NCT00935311|E1|Reported Event|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
579932|NCT00935493|B4|Baseline|Total|Total of all reporting groups
579933|NCT00935493|B3|Baseline|Placebo po Qhs|Placebo: Placebo po qhs
579934|NCT00935493|B2|Baseline|Guanfacine 0.5 mg po Qhs|Guanfacine: Guanfacine 0.5 mg po qhs
579935|NCT00935493|B1|Baseline|Guanfacine 0.1 mg po Qhs|Guanfacine: Guanfacine 0.1 mg po qhs
579936|NCT00935493|P3|Participant Flow|Placebo po Qhs|Placebo: Placebo po qhs
579937|NCT00935493|P2|Participant Flow|Guanfacine 0.5 mg po Qhs|Guanfacine: Guanfacine 0.5 mg po qhs
579938|NCT00935493|P1|Participant Flow|Guanfacine 0.1 mg po Qhs|Guanfacine: Guanfacine 0.1 mg po qhs
579939|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
579940|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
579941|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
579942|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
579943|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
579946|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
579947|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
579948|NCT00935493|E3|Reported Event|Placebo|Placebo: Placebo
579949|NCT00935493|E2|Reported Event|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
579950|NCT00935493|E1|Reported Event|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
579951|NCT00935532|B3|Baseline|Total|Total of all reporting groups
579952|NCT00935532|B2|Baseline|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579953|NCT00935532|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579954|NCT00935532|P2|Participant Flow|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579955|NCT00935532|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579956|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579957|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579958|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579959|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579960|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579961|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579962|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579963|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579964|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579965|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579966|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579967|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579968|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579969|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579970|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579971|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579972|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579973|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579974|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579975|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579976|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579978|NCT00935532|E2|Reported Event|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
579979|NCT00935532|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
579980|NCT00935584|B3|Baseline|Total|Total of all reporting groups
579981|NCT00935584|B2|Baseline|PACE Study Providers|23 providers participated in the study. However, final analysis was based on 126 clinic visits.
579982|NCT00935584|B1|Baseline|PACE Study Patients|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.
Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
579983|NCT00935584|P2|Participant Flow|PACE Study Providers|23 primary care providers started and 19 completed the study. 22 primary care providers participated in the educational workshop.
579984|NCT00935584|P1|Participant Flow|PACE Study Patients|"The proposed study will use a quasi-experimental (pre-post intervention design). Pre-intervention phase consisted of baseline data collection on EMR usage and patient-physician communication.
126 patients started the study and 77 completed the study."
579985|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.
Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
579986|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.
Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
579987|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.
Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
579988|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.
Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
580029|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
579989|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.
Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
579990|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.
Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
579991|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.
Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
579992|NCT00935584|E1|Reported Event|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.
Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
579993|NCT00941304|B6|Baseline|Total|Total of all reporting groups
579994|NCT00941304|B5|Baseline|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
579995|NCT00941304|B4|Baseline|Placebo|Placebo oral capsule and 2 placebo buccal films
579996|NCT00941304|B3|Baseline|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
579997|NCT00941304|B2|Baseline|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
579998|NCT00941304|B1|Baseline|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
579999|NCT00941304|P5|Participant Flow|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
580000|NCT00941304|P4|Participant Flow|Placebo|Placebo oral capsule and 2 placebo buccal films
580001|NCT00941304|P3|Participant Flow|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580002|NCT00941304|P2|Participant Flow|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580003|NCT00941304|P1|Participant Flow|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine hydrochloride (HCl) buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580004|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
580005|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
580006|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580055|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
580007|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580008|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580009|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
580010|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
580011|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580012|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580013|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580014|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
580015|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
580016|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580017|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580018|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580019|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
580020|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
580021|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580022|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580023|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580024|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
580025|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
580026|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580027|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580028|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580030|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
580031|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580032|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580033|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580034|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
580035|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
580036|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580037|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580038|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580039|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
580040|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
580041|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580042|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580043|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580044|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
580045|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
580046|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580047|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580048|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580049|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
580050|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
580051|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580052|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580053|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580056|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580057|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580058|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580059|NCT00941304|E5|Reported Event|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
580060|NCT00941304|E4|Reported Event|Placebo|Placebo oral capsule and 2 placebo buccal films
580061|NCT00941304|E3|Reported Event|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
580062|NCT00941304|E2|Reported Event|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580063|NCT00941304|E1|Reported Event|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
580064|NCT00941330|B3|Baseline|Total|Total of all reporting groups
580065|NCT00941330|B2|Baseline|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
580066|NCT00941330|B1|Baseline|A: Exemestane|"ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months."
580067|NCT00941330|P2|Participant Flow|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
580068|NCT00941330|P1|Participant Flow|A: Exemestane|"ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months."
580069|NCT00941330|O2|Outcome|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
580070|NCT00941330|O1|Outcome|A: Exemestane|"ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months."
580071|NCT00941330|O2|Outcome|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
580113|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580072|NCT00941330|O1|Outcome|A: Exemestane|"ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months."
580073|NCT00941330|E2|Reported Event|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
580074|NCT00941330|E1|Reported Event|A: Exemestane|"ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months."
580075|NCT00941603|B7|Baseline|Total|Total of all reporting groups
580076|NCT00941603|B6|Baseline|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
580077|NCT00941603|B5|Baseline|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580078|NCT00941603|B4|Baseline|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580079|NCT00941603|B3|Baseline|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580080|NCT00941603|B2|Baseline|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580081|NCT00941603|B1|Baseline|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580082|NCT00941603|P6|Participant Flow|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
580083|NCT00941603|P5|Participant Flow|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580084|NCT00941603|P4|Participant Flow|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580085|NCT00941603|P3|Participant Flow|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580086|NCT00941603|P2|Participant Flow|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580087|NCT00941603|P1|Participant Flow|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580088|NCT00941603|O6|Outcome|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
580089|NCT00941603|O5|Outcome|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580090|NCT00941603|O4|Outcome|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580091|NCT00941603|O3|Outcome|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580092|NCT00941603|O2|Outcome|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
582061|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
580093|NCT00941603|O1|Outcome|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580094|NCT00941603|O6|Outcome|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
580095|NCT00941603|O5|Outcome|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580096|NCT00941603|O4|Outcome|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580097|NCT00941603|O3|Outcome|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580098|NCT00941603|O2|Outcome|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580099|NCT00941603|O1|Outcome|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580100|NCT00941603|E6|Reported Event|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
580101|NCT00941603|E5|Reported Event|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580102|NCT00941603|E4|Reported Event|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580103|NCT00941603|E3|Reported Event|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580104|NCT00941603|E2|Reported Event|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580105|NCT00941603|E1|Reported Event|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
580106|NCT00941798|B3|Baseline|Total|Total of all reporting groups
580107|NCT00941798|B2|Baseline|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580108|NCT00941798|B1|Baseline|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580109|NCT00941798|P2|Participant Flow|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580110|NCT00941798|P1|Participant Flow|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580111|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580112|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
581168|NCT00943852|E5|Reported Event|ISMN 60 mg|
580114|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580115|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580116|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580117|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580118|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580119|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580120|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580121|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580122|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580123|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580124|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580125|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580126|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580127|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580128|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580129|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580130|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580131|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580132|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580133|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580134|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580135|NCT00941798|E2|Reported Event|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
580136|NCT00941798|E1|Reported Event|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
580137|NCT00941863|B6|Baseline|Total|Total of all reporting groups
580138|NCT00941863|B5|Baseline|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
580139|NCT00941863|B4|Baseline|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
580140|NCT00941863|B3|Baseline|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
580141|NCT00941863|B2|Baseline|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
580142|NCT00941863|B1|Baseline|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
580143|NCT00941863|P5|Participant Flow|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
580144|NCT00941863|P4|Participant Flow|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
580145|NCT00941863|P3|Participant Flow|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
580146|NCT00941863|P2|Participant Flow|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
580147|NCT00941863|P1|Participant Flow|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
580148|NCT00941863|O1|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
580149|NCT00941863|O1|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
580150|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
580151|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
580152|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
580153|NCT00941863|O6|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
580154|NCT00941863|O5|Outcome|Sorafenib 400 mg (Expansion, Treatment Until PCD)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
580155|NCT00941863|O4|Outcome|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
580156|NCT00941863|O3|Outcome|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
580157|NCT00941863|O2|Outcome|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
580301|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580158|NCT00941863|O1|Outcome|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
580159|NCT00941863|O6|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
580160|NCT00941863|O5|Outcome|Sorafenib 400 mg (Expansion, Treatment Until PCD)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
580161|NCT00941863|O4|Outcome|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
580162|NCT00941863|O3|Outcome|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
580163|NCT00941863|O2|Outcome|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
580164|NCT00941863|O1|Outcome|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
580165|NCT00941863|O1|Outcome|Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid|All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid [twice daily], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
580166|NCT00941863|E5|Reported Event|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
580167|NCT00941863|E4|Reported Event|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
580168|NCT00941863|E3|Reported Event|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
580169|NCT00941863|E2|Reported Event|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
580170|NCT00941863|E1|Reported Event|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
580171|NCT00941889|B3|Baseline|Total|Total of all reporting groups
580172|NCT00941889|B2|Baseline|Gardasil|Patients in this group received Gardasil injection at initial date, 2 months and 6 months after enrollment.
580173|NCT00941889|B1|Baseline|Placebo|Patients in this group received placebo of saline at initial date, 2 months and 6 months after enrollment.
580174|NCT00941889|P2|Participant Flow|Gardasil Group|The treatment group will receive a 0.5 mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
580175|NCT00941889|P1|Participant Flow|Placebo|Patients who are in the control group will receive a placebo of saline at initial date, 2 months and 6 months.
580176|NCT00941889|O2|Outcome|Gardasil Group|Patients who received Gardasil injection at initial visit, 2 months, and 6 months after enrollment.
580177|NCT00941889|O1|Outcome|Placebo Group|Patients who received placebo of saline at initial visit, 2 months and 6 months after enrollment.
580231|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580178|NCT00941889|E2|Reported Event|Treatment Group|The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
580179|NCT00941889|E1|Reported Event|Placebo|Patients who are in the control group received a placebo of saline at initial date, 2 months and 6 months.
580180|NCT00941928|B1|Baseline|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
580181|NCT00941928|P1|Participant Flow|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
580182|NCT00941928|O1|Outcome|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
580183|NCT00941928|E1|Reported Event|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
580184|NCT00941993|B1|Baseline|Iontophoretic Delivery of Anesthesia|"Tympanic membrane anesthesia delivery system
Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
580185|NCT00941993|P1|Participant Flow|Iontophoretic Delivery of Local Anesthesia|"Tympanic membrane anesthesia delivery system
Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
580186|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system
Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
580187|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system
Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
580188|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system
Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
580189|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system
Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
580190|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system
Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
580191|NCT00941993|E1|Reported Event|Anesthesia|"tympanic membrane anesthesia delivery system
Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
580192|NCT00942084|B1|Baseline|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
580193|NCT00942084|P1|Participant Flow|Acyclovir Study Enrollment|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
580194|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
580195|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
580196|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
580232|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
582786|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
580197|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
580198|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
580199|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
580200|NCT00942084|E1|Reported Event|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
580201|NCT00942149|B1|Baseline|Daptomycin Cohort|There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
580202|NCT00942149|P1|Participant Flow|Daptomycin Cohort|There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
580203|NCT00942149|O1|Outcome|Area Under the Curve - 24 Hours|pharmacokinetics of daptomycin
580204|NCT00942149|E1|Reported Event|Daptomycin Cohort|
580205|NCT00942175|B5|Baseline|Total|Total of all reporting groups
580206|NCT00942175|B4|Baseline|PPI Group 4|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days."
580207|NCT00942175|B3|Baseline|PPI Group 3|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days."
580208|NCT00942175|B2|Baseline|PPI Group 2|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days."
580209|NCT00942175|B1|Baseline|PPI Group 1|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days."
580210|NCT00942175|P4|Participant Flow|PPI Group 4|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days."
580211|NCT00942175|P3|Participant Flow|PPI Group 3|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days."
580212|NCT00942175|P2|Participant Flow|PPI Group 2|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days."
580213|NCT00942175|P1|Participant Flow|PPI Group 1|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days."
580214|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
580215|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580216|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
580217|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580218|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
580219|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580220|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
580221|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580222|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
580223|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580224|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
580225|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580226|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
580227|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580228|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
580229|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580230|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
580233|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580234|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
580235|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580236|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
580237|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580238|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
580239|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580240|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
580241|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580242|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
580243|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580244|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
580245|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580246|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
580247|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580248|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
580249|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580250|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
580251|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580252|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
580253|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580254|NCT00942175|E8|Reported Event|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
580255|NCT00942175|E7|Reported Event|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580256|NCT00942175|E6|Reported Event|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
580257|NCT00942175|E5|Reported Event|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580258|NCT00942175|E4|Reported Event|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
580259|NCT00942175|E3|Reported Event|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580260|NCT00942175|E2|Reported Event|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
580261|NCT00942175|E1|Reported Event|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
580262|NCT00942266|B3|Baseline|Total|Total of all reporting groups
580263|NCT00942266|B2|Baseline|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580264|NCT00942266|B1|Baseline|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580265|NCT00942266|P2|Participant Flow|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580266|NCT00942266|P1|Participant Flow|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580267|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580268|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580340|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
580341|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
580342|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
580269|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580270|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580271|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580272|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580273|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580274|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580275|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580276|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580277|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580299|NCT00942448|P1|Participant Flow|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580300|NCT00942448|O4|Outcome|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
580278|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580279|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580280|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580281|NCT00942266|E2|Reported Event|Arm II|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580282|NCT00942266|E1|Reported Event|Arm I|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study"
580283|NCT00942409|B1|Baseline|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
580284|NCT00942409|P1|Participant Flow|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
580285|NCT00942409|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
580343|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
580344|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
580345|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
580286|NCT00942409|E1|Reported Event|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
580287|NCT00942422|B1|Baseline|Defined Green Tea Catechin Extract / Correlative Analysis|Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal). Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
580288|NCT00942422|P1|Participant Flow|Defined Green Tea Catechin Extract / Correlative Analysis|Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
580289|NCT00942422|O1|Outcome|Defined Green Tea Catechin Extract / Correlative Analysis|"Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
defined green tea catechin extract: Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the"
580290|NCT00942422|E1|Reported Event|Defined Green Tea Catechin Extract / Correlative Analysis|"Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the"
580291|NCT00942448|B5|Baseline|Total|Total of all reporting groups
580292|NCT00942448|B4|Baseline|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
580293|NCT00942448|B3|Baseline|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580294|NCT00942448|B2|Baseline|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580295|NCT00942448|B1|Baseline|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580296|NCT00942448|P4|Participant Flow|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
580297|NCT00942448|P3|Participant Flow|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580298|NCT00942448|P2|Participant Flow|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
581169|NCT00943852|E4|Reported Event|Losartan 100 mg + ISMN 60 mg|
580302|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580303|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580304|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
580305|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
580306|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
580307|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
580308|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
580309|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
580310|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
580311|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
580312|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
580313|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
580314|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
580315|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
580316|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
580317|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
580318|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
580319|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
580320|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
580321|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
580322|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
580323|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
580324|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
580325|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
580326|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
580327|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
580328|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
580329|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
580330|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
580331|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
580332|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
580333|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
580334|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
580335|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
580336|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
580337|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
580338|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
580339|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
580352|NCT00942448|O4|Outcome|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
580353|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580354|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580355|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580356|NCT00942448|E4|Reported Event|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
580357|NCT00942448|E3|Reported Event|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580358|NCT00942448|E2|Reported Event|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580359|NCT00942448|E1|Reported Event|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
580360|NCT00942604|B3|Baseline|Total|Total of all reporting groups
580361|NCT00942604|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
580362|NCT00942604|B1|Baseline|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
580363|NCT00942604|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
580364|NCT00942604|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
580365|NCT00942604|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
580366|NCT00942604|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
580367|NCT00942604|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
580368|NCT00942604|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
580369|NCT00942604|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
580370|NCT00942604|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
580371|NCT00942734|B1|Baseline|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
580372|NCT00942734|P1|Participant Flow|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
580373|NCT00942734|O1|Outcome|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
580374|NCT00942734|E1|Reported Event|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
580375|NCT00942786|B1|Baseline|One Arm|consecutive patients presenting for emergent non-cardiac surgery
580376|NCT00942786|P1|Participant Flow|No Treatment|Consecutive patients undergoing emergency surgery
580377|NCT00942786|O2|Outcome|Patients Not Sustaining Adverse Events|Subjects who did not reach the primary endpoint
580378|NCT00942786|O1|Outcome|Patients Sustaining Adverse Events|Subjects who reached the primary endpoint
580379|NCT00942786|O1|Outcome|All Patients|Consecutive patients undergoing emergent non-cardiac surgery
580380|NCT00942786|O1|Outcome|No Treatment|Consecutive patients undergoing emergency surgery
580381|NCT00942786|E1|Reported Event|One Arm|"consecutive patients presenting for emergent non-cardiac surgery
Patients were followed for occurence of major adverse cardiac events"
580382|NCT00942825|B3|Baseline|Total|Total of all reporting groups
580383|NCT00942825|B2|Baseline|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed
Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
580384|NCT00942825|B1|Baseline|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2
CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
580385|NCT00942825|P2|Participant Flow|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed
Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
580386|NCT00942825|P1|Participant Flow|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2
CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
580387|NCT00942825|O2|Outcome|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed
Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
580388|NCT00942825|O1|Outcome|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2
CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
582612|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
580389|NCT00942825|E2|Reported Event|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed
Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
580390|NCT00942825|E1|Reported Event|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2
CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
580391|NCT00942851|B3|Baseline|Total|Total of all reporting groups
580392|NCT00942851|B2|Baseline|Placebo|topical intervention WITHOUT AH-8
580393|NCT00942851|B1|Baseline|Active|AH-8 containing topical intervention
580394|NCT00942851|P2|Participant Flow|Placebo|"Topical intervention agent WITHOUT AH-8. Identically appearing cream without the active ingredient.
Twice daily application to the eyelids in standardized fashion."
580395|NCT00942851|P1|Participant Flow|Active|Topical intervention agent containing AH8 0.005% Twice daily application to the eyelids in standardized fashion.
580396|NCT00942851|O2|Outcome|Placebo|topical intervention WITHOUT AH-8
580397|NCT00942851|O1|Outcome|Active|AH-8 containing topical intervention
580398|NCT00942851|O2|Outcome|Placebo|
580399|NCT00942851|O1|Outcome|Active Ingredient- AH8|
580400|NCT00942851|O2|Outcome|Placebo|subjects receiving placebo intervention, ie identically-appearing topical cream without AH-8 content
580401|NCT00942851|O1|Outcome|Active Ingredient- AH8|subjects receiving active intervention, ie topical cream containing 0.005% AH-8
580402|NCT00942851|E2|Reported Event|Placebo|topical intervention WITHOUT AH-8
580403|NCT00942851|E1|Reported Event|Active|AH-8 containing topical intervention
580404|NCT00942903|B1|Baseline|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
580405|NCT00942903|P1|Participant Flow|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
580406|NCT00942903|O1|Outcome|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
580407|NCT00942903|O1|Outcome|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
581081|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
580408|NCT00942903|E1|Reported Event|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
580409|NCT00942968|B1|Baseline|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580410|NCT00942968|P1|Participant Flow|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580411|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580412|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580413|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580414|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580415|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580416|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580417|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580418|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580419|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580420|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580421|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580422|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580423|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580424|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580425|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580426|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580427|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580428|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580429|NCT00942968|E1|Reported Event|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
580430|NCT00942994|B3|Baseline|Total|Total of all reporting groups
580431|NCT00942994|B2|Baseline|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
580432|NCT00942994|B1|Baseline|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
580433|NCT00942994|P2|Participant Flow|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
580455|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
580456|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
580434|NCT00942994|P1|Participant Flow|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
580435|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
580436|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
580437|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
580438|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
580439|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
580440|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
580441|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
580442|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
580443|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
580444|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
582613|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
580445|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
580446|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
580447|NCT00942994|E2|Reported Event|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
580448|NCT00942994|E1|Reported Event|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
580449|NCT00943072|B3|Baseline|Total|Total of all reporting groups
580450|NCT00943072|B2|Baseline|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
580451|NCT00943072|B1|Baseline|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
580452|NCT00943072|P2|Participant Flow|Sham Treatment|"Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given."
580453|NCT00943072|P1|Participant Flow|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|"Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk."
580454|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
581082|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
580457|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
580458|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
580459|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
580460|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
580461|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
580462|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
580463|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
580464|NCT00943072|E4|Reported Event|Sham Treatment to IAI (Week 24 to Week 100)|"Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given."
580465|NCT00943072|E3|Reported Event|IAI to IAI (Week 24 to Week 100)|"Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.
From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk."
580466|NCT00943072|E2|Reported Event|Sham Treatment (Baseline to Week 24)|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
580467|NCT00943072|E1|Reported Event|Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24)|"Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 20. Participants were observed until Week 24.
Participants in the safety population were at risk."
580468|NCT00943098|B3|Baseline|Total|Total of all reporting groups
580469|NCT00943098|B2|Baseline|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580470|NCT00943098|B1|Baseline|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580471|NCT00943098|P2|Participant Flow|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580472|NCT00943098|P1|Participant Flow|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
582614|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
580473|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580474|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580475|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580476|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580477|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580478|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580479|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580480|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580481|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580482|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580483|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580484|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580485|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580486|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580487|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580488|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580489|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580490|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580491|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580492|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580493|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580494|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580495|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580496|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580497|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580498|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580499|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580500|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580501|NCT00943098|E2|Reported Event|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
580502|NCT00943098|E1|Reported Event|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
580503|NCT00943111|B3|Baseline|Total|Total of all reporting groups
580504|NCT00943111|B2|Baseline|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
580505|NCT00943111|B1|Baseline|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
580506|NCT00943111|P3|Participant Flow|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.
Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was <5 ng/mL next higher dose was administered whereas if the Genz-99067 trough plasma concentration was >=5 ng/mL the same dose was continued. PK assessment at Week 54 and Week 58 were used for dose adjustment after Week 56 and Week 60, respectively."
580507|NCT00943111|P2|Participant Flow|Imiglucerase: PAP|Imiglucerase (Cerezyme®) intravenous infusion every other week (q2w) up to Week 52 in doses equivalent to participant’s past enzyme replacement therapy (ERT) dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
580508|NCT00943111|P1|Participant Flow|Eliglustat: PAP|Eliglustat tartrate (Genz-112638) capsule 50 milligram (mg) twice daily (BID) orally from Day 1 to Week 4 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 8, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 52. The dose adjustments after Week 4 and Week 8 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was less than [<] 5 nanogram per milliliter [ng/mL] the next higher dose was administered whereas if the Genz-99067 trough plasma concentration was greater than or equal to [>=] 5 ng/mL the same dose was continued. The pharmacokinetic (PK) assessment at Week 2 and Week 6 were used for dose adjustment after Week 4 and Week 8, respectively.
582787|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
580509|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.
Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
580510|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.
Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
580511|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.
Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
580512|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.
Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
580513|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.
Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
581083|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
580514|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.
Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
580515|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
580516|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
580517|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
580518|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
580519|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
580520|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
580521|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
580522|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
580523|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
580524|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
580525|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
580526|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
580527|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
582615|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
580528|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
580529|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
580530|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
580531|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
580532|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
580533|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.
Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
580534|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
580535|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
580536|NCT00943111|E2|Reported Event|Imiglucerase|PAP: Imiglucerase (Cerezyme®) intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change. LTTP: Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz­99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations.
580537|NCT00943111|E1|Reported Event|Eliglustat|PAP: Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52. Dose adjustments after Week 4 and Week 8 were based on Genz­99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. LTTP: Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
580538|NCT00943124|B1|Baseline|Overall Study Population|All randomized patients
580686|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580539|NCT00943124|P2|Participant Flow|Simvastatin + MK0524A Then MK0524B|"Period 1: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets.
Period 2: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet)."
580540|NCT00943124|P1|Participant Flow|MK0524B Then Simvastatin + MK0524A|"Period 1: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet).
Period 2: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets."
580541|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
580542|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
580543|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
580544|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
580545|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
580546|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
580547|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
580548|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
580549|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
580550|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
580551|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
580552|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
580553|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
580554|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
580555|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
580556|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
580836|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
580557|NCT00943124|E2|Reported Event|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
580558|NCT00943124|E1|Reported Event|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
580559|NCT00943150|B3|Baseline|Total|Total of all reporting groups
580560|NCT00943150|B2|Baseline|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
580561|NCT00943150|B1|Baseline|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
580562|NCT00943150|P2|Participant Flow|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
580563|NCT00943150|P1|Participant Flow|PEAK PlasmaBlade|The PEAK PlasmaBlade for the abdominoplasty procedure.
580564|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
580565|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
580566|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
580567|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
580568|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
580569|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
580570|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
580571|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
580572|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
580573|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
580574|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
580575|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
580576|NCT00943150|O3|Outcome|Scalpel|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
580577|NCT00943150|O2|Outcome|Electrosurgery|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
580578|NCT00943150|O1|Outcome|PEAK PlasmaBlade|A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.
580579|NCT00943150|O2|Outcome|Electrocautery|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
581170|NCT00943852|E3|Reported Event|Losartan 100 mg + ISMN 15 mg|
580580|NCT00943150|O1|Outcome|PEAK PlasmaBlade|A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.
580581|NCT00943150|E2|Reported Event|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
580582|NCT00943150|E1|Reported Event|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
580583|NCT00943202|B5|Baseline|Total|Total of all reporting groups
580584|NCT00943202|B4|Baseline|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580585|NCT00943202|B3|Baseline|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580586|NCT00943202|B2|Baseline|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580587|NCT00943202|B1|Baseline|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580588|NCT00943202|P4|Participant Flow|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580589|NCT00943202|P3|Participant Flow|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580590|NCT00943202|P2|Participant Flow|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580591|NCT00943202|P1|Participant Flow|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580592|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580593|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580594|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580595|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580596|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
582616|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
580597|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580598|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580599|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580600|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580601|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580602|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580603|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580604|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580605|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580606|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580607|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580608|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580609|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580610|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580611|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580612|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580613|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580614|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580615|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580616|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580617|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580618|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580619|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580620|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580621|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580622|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580623|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580624|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580625|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580626|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580627|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580628|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580629|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580630|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580631|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580837|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
580632|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580633|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580634|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580635|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580636|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580637|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580638|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580639|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580640|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580641|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580642|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580643|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580644|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580645|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580646|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580647|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580648|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580649|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580650|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580865|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580651|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580652|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580653|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580654|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580655|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580656|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580657|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580658|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580659|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580660|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580661|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580662|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580663|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580664|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580665|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580666|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580667|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580668|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580669|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580670|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580671|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580672|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580673|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580674|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580675|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580676|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580677|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580678|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580679|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580680|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580681|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580682|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580683|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580684|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580685|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
581084|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
580687|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580688|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580689|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580690|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580691|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580692|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580693|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580694|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580695|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580696|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580697|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580698|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580699|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580700|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580701|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580702|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580703|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580704|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580705|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580706|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580707|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580708|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580709|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580710|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580711|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580712|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580713|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580714|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580715|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580716|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580717|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580718|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580719|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580720|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580721|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581085|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
580722|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580723|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580724|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580725|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580726|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580727|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580728|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580729|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580730|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580731|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580732|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580733|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580734|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580735|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580736|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580737|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580738|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580739|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580740|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580741|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580742|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580743|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580744|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580745|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580746|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580747|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580748|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580749|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580750|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580751|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580752|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580753|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580754|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580755|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580756|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
581086|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
580757|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580758|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580759|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580760|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580761|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580762|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580763|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580764|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580765|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580766|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580767|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580768|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580769|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580770|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580771|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580772|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580773|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580774|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580775|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580776|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580777|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580778|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580779|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580780|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580781|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580782|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580783|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580784|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580785|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580786|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580787|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580788|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580789|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580790|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580791|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580866|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580792|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580793|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580794|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580795|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580796|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580797|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580798|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580799|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580800|NCT00943202|E4|Reported Event|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
580801|NCT00943202|E3|Reported Event|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
580802|NCT00943202|E2|Reported Event|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
580803|NCT00943202|E1|Reported Event|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
580804|NCT00943384|B1|Baseline|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580805|NCT00943384|P1|Participant Flow|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
582617|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
580806|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580807|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580808|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580809|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580810|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580811|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580812|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580813|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580814|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580815|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580816|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580867|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580868|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580817|NCT00943384|E1|Reported Event|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
580818|NCT00943397|B3|Baseline|Total|Total of all reporting groups
580819|NCT00943397|B2|Baseline|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
580820|NCT00943397|B1|Baseline|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
580821|NCT00943397|P2|Participant Flow|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
580822|NCT00943397|P1|Participant Flow|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
580823|NCT00943397|O2|Outcome|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
580824|NCT00943397|O1|Outcome|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
580825|NCT00943397|E2|Reported Event|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
580826|NCT00943397|E1|Reported Event|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
580827|NCT00943436|B3|Baseline|Total|Total of all reporting groups
580828|NCT00943436|B2|Baseline|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
580829|NCT00943436|B1|Baseline|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
580830|NCT00943436|P2|Participant Flow|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
580831|NCT00943436|P1|Participant Flow|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
580832|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
580833|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
580834|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
580835|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
580838|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
580839|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
580840|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
580841|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
580842|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
580843|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
580844|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
580845|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
580846|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
580847|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
580848|NCT00943436|E2|Reported Event|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
580849|NCT00943436|E1|Reported Event|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
580850|NCT00943488|B3|Baseline|Total|Total of all reporting groups
580851|NCT00943488|B2|Baseline|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580852|NCT00943488|B1|Baseline|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580853|NCT00943488|P2|Participant Flow|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580854|NCT00943488|P1|Participant Flow|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580855|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580856|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580857|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580858|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580859|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580860|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580861|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580862|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580863|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580864|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580869|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580870|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580871|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580872|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580873|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580874|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580875|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580876|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580877|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580878|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580879|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580880|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580881|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580882|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580883|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580884|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580885|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580886|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580887|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580888|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580889|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580890|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580891|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580892|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580893|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580894|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580895|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580896|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580897|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580898|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580899|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580900|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580901|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580902|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580903|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580904|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580905|NCT00943488|E2|Reported Event|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580906|NCT00943488|E1|Reported Event|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580907|NCT00943579|B3|Baseline|Total|Total of all reporting groups
580908|NCT00943579|B2|Baseline|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
580909|NCT00943579|B1|Baseline|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
580910|NCT00943579|P2|Participant Flow|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
580911|NCT00943579|P1|Participant Flow|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
580912|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
580913|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
580914|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
580915|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
580916|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|
580917|NCT00943579|O1|Outcome|Kuvan Following Placebo|
580918|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
580919|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
580920|NCT00943579|E2|Reported Event|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
580921|NCT00943579|E1|Reported Event|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
580922|NCT00943592|B1|Baseline|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
580923|NCT00943592|P1|Participant Flow|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
580924|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
582618|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
580925|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
580926|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
580927|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
580928|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
580929|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
580930|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
580931|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
580932|NCT00943592|E1|Reported Event|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
580933|NCT00943605|B3|Baseline|Total|Total of all reporting groups
580934|NCT00943605|B2|Baseline|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
580935|NCT00943605|B1|Baseline|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
580936|NCT00943605|P2|Participant Flow|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
580937|NCT00943605|P1|Participant Flow|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
580938|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
580939|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
580940|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
580941|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
580942|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
580943|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
580944|NCT00943605|E2|Reported Event|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
580945|NCT00943605|E1|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
580946|NCT00943631|B3|Baseline|Total|Total of all reporting groups
580947|NCT00943631|B2|Baseline|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580948|NCT00943631|B1|Baseline|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580949|NCT00943631|P2|Participant Flow|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580950|NCT00943631|P1|Participant Flow|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580951|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580952|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580953|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580954|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580955|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580956|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580957|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580958|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580959|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580960|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580961|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580962|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580963|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580964|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580965|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580966|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580967|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580968|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580969|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580970|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580971|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580972|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580973|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580974|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580975|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580976|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580977|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580978|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580979|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580980|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580981|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580982|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580983|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580984|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580985|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580986|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580987|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580988|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580989|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580990|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580991|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580992|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580993|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580994|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580995|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580996|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580997|NCT00943631|E2|Reported Event|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580998|NCT00943631|E1|Reported Event|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
580999|NCT00943670|B1|Baseline|T-DM1 / T-DM1 + Pertuzumab|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
From Cycle 4, participants with early Progressive disease (demonstrated prior to the end of Cycle 6) could receive combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, starting at the cycle after tumor progression was determined, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
581024|NCT00943670|O1|Outcome|Average QTc Interval ≤ 450 ms|Participants with an average QTc interval less than or equal to 450 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581000|NCT00943670|P1|Participant Flow|T-DM1 / T-DM1 + Pertuzumab|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
From Cycle 4, participants with early Progressive disease (demonstrated prior to the end of Cycle 6) could receive combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, starting at the cycle after tumor progression was determined, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
581001|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581002|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581003|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581004|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581005|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581006|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581007|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581008|NCT00943670|O2|Outcome|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
581009|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581010|NCT00943670|O2|Outcome|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
581011|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581012|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
581013|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
581048|NCT00943722|P5|Participant Flow|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581087|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581014|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
581015|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
581016|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581017|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581018|NCT00943670|O3|Outcome|Baseline-adjusted QTc Interval > 60 ms|Participants with an average Baseline-adjusted QTc interval greater than 60 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581019|NCT00943670|O2|Outcome|Baseline-adjusted QTc Interval > 30 to ≤ 60 ms|Participants with an average Baseline-adjusted QTc interval greater than 30 and less than or equal to 60 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581020|NCT00943670|O1|Outcome|Baseline-adjusted QTc Interval ≤ 30 ms|Participants with an average Baseline-adjusted QTc interval less than or equal to 30 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581021|NCT00943670|O4|Outcome|Average QTc Interval > 500 ms|Participants with an average QTc interval greater than 500 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581022|NCT00943670|O3|Outcome|Average QTc Interval > 480 to ≤ 500 ms|Participants with an average QTc interval greater than 480 and less than or equal to 500 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581023|NCT00943670|O2|Outcome|Average QTc Interval > 450 to ≤ 480 ms|Participants with an average QTc interval greater than 450 and less than or equal to 480 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581025|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581026|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581027|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581028|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581029|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581030|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581031|NCT00943670|E2|Reported Event|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
581032|NCT00943670|E1|Reported Event|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
581033|NCT00943683|B3|Baseline|Total|Total of all reporting groups
581034|NCT00943683|B2|Baseline|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
581035|NCT00943683|B1|Baseline|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
581036|NCT00943683|P2|Participant Flow|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
581037|NCT00943683|P1|Participant Flow|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
581038|NCT00943683|O2|Outcome|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
581039|NCT00943683|O1|Outcome|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
581040|NCT00943683|E2|Reported Event|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
581041|NCT00943683|E1|Reported Event|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
581042|NCT00943722|B6|Baseline|Total|Total of all reporting groups
581043|NCT00943722|B5|Baseline|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581044|NCT00943722|B4|Baseline|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581045|NCT00943722|B3|Baseline|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
581046|NCT00943722|B2|Baseline|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
581047|NCT00943722|B1|Baseline|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581049|NCT00943722|P4|Participant Flow|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581050|NCT00943722|P3|Participant Flow|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
581051|NCT00943722|P2|Participant Flow|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
581052|NCT00943722|P1|Participant Flow|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581053|NCT00943722|O3|Outcome|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
581054|NCT00943722|O2|Outcome|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
581055|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581056|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581057|NCT00943722|O1|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581058|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581059|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581060|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581061|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581062|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2, or 3)|Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
581063|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581064|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581065|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
581066|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581067|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581068|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
581069|NCT00943722|O3|Outcome|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
581070|NCT00943722|O2|Outcome|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
581071|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581072|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581073|NCT00943722|O1|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581074|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581075|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581076|NCT00943722|E3|Reported Event|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581077|NCT00943722|E2|Reported Event|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
581078|NCT00943722|E1|Reported Event|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
581079|NCT00943735|B1|Baseline|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581080|NCT00943735|P1|Participant Flow|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581088|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581089|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581090|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581091|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581092|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581093|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581094|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581095|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581096|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581097|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581098|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581099|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581100|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581101|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581102|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581103|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581104|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581105|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581106|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581107|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581108|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581109|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581110|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581111|NCT00943735|E1|Reported Event|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
581112|NCT00943761|B3|Baseline|Total|Total of all reporting groups
581113|NCT00943761|B2|Baseline|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
581114|NCT00943761|B1|Baseline|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
581115|NCT00943761|P2|Participant Flow|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
581116|NCT00943761|P1|Participant Flow|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination pegylated interferon (peg-IFN) 180 mcg weekly and ribavirin (RBV) 1000 or 1200 mg administered as a divided dose twice daily.
581117|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
581118|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
581119|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
581120|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
581121|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
581122|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
581123|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
581124|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
581125|NCT00943761|E2|Reported Event|Vaniprevir 600 mg Bid + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
581126|NCT00943761|E1|Reported Event|Vaniprevir 300 mg Bid + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
581127|NCT00943787|B1|Baseline|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
581128|NCT00943787|P1|Participant Flow|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
581161|NCT00943852|P3|Participant Flow|ISMN / Losartan + ISMN / Placebo / Losartan / Losartan + ISMN|ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg – single dose with ≥ 4 days washout between doses
581129|NCT00943787|O1|Outcome|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
581130|NCT00943787|O1|Outcome|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
581131|NCT00943787|E1|Reported Event|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
581132|NCT00943826|B3|Baseline|Total|Total of all reporting groups
581133|NCT00943826|B2|Baseline|Placebo + RT +Temozolomide|In the Concurrent Phase participants received RT in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581134|NCT00943826|B1|Baseline|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
582788|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
581135|NCT00943826|P2|Participant Flow|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581136|NCT00943826|P1|Participant Flow|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581137|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581138|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581162|NCT00943852|P2|Participant Flow|Losartan / ISMN / Losartan + ISMN / Placebo / Losartan + ISMN|Losartan 100 mg / ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 15 mg – single dose with ≥ 4 days washout between doses
581171|NCT00943852|E2|Reported Event|Losartan 100 mg|
581172|NCT00943852|E1|Reported Event|Placebo|
581173|NCT00943878|B5|Baseline|Total|Total of all reporting groups
581139|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581140|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581141|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581185|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581186|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581142|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581143|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581144|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581145|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581146|NCT00943826|O1|Outcome|Bevacizumab + RT +Temozolomide|In the Concurrent Phase participants received RT in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
581163|NCT00943852|P1|Participant Flow|Placebo / Losartan / Losartan + ISMN / Losartan + ISMN / ISMN|Placebo / Losartan 100 mg / Losartan 100 mg + Isosorbide Mononitrate (ISMN) 15 mg / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg – single dose with ≥ 4 days washout between doses
581147|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581148|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581149|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581150|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581151|NCT00943826|E2|Reported Event|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581152|NCT00943826|E1|Reported Event|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
581153|NCT00943852|B1|Baseline|All Participants in Study|
581154|NCT00943852|P10|Participant Flow|Losartan + ISMN / Losartan / Placebo / Losartan + ISMN / ISMN|Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / Placebo / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg – single dose with ≥ 4 days washout between doses
581155|NCT00943852|P9|Participant Flow|Losartan + ISMN / Placebo / Losartan + ISMN / ISMN / Losartan|Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg / Losartan 100 mg – single dose with ≥ 4 days washout between doses
581156|NCT00943852|P8|Participant Flow|ISMN / Losartan + ISMN / Losartan + ISMN / Losartan / Placebo|ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg / Placebo – single dose with ≥ 4 days washout between doses
581157|NCT00943852|P7|Participant Flow|Losartan / Losartan + ISMN / ISMN / Placebo / Losartan + ISMN|Losartan 100 mg / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 60 mg – single dose with ≥ 4 days washout between doses
581158|NCT00943852|P6|Participant Flow|Placebo / ISMN / Losartan / Losartan + ISMN / Losartan + ISMN|Placebo / ISMN 60 mg / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg – single dose with ≥ 4 days washout between doses
581159|NCT00943852|P5|Participant Flow|Losartan + ISMN / Placebo / ISMN / Losartan + ISMN / Losartan|Losartan 100 mg + ISMN 60 mg / Placebo / ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg – single dose with ≥ 4 days washout between doses
581160|NCT00943852|P4|Participant Flow|Losartan + ISMN / Losartan + ISMN / Losartan / ISMN / Placebo|Losartan 100 mg + ISMN 15 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / ISMN 60 mg / Placebo – single dose with ≥ 4 days washout between doses
581174|NCT00943878|B4|Baseline|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581175|NCT00943878|B3|Baseline|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581176|NCT00943878|B2|Baseline|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581177|NCT00943878|B1|Baseline|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581178|NCT00943878|P4|Participant Flow|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581179|NCT00943878|P3|Participant Flow|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581180|NCT00943878|P2|Participant Flow|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581181|NCT00943878|P1|Participant Flow|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581182|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581183|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581184|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581187|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581188|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581189|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581190|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581191|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581192|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581193|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581194|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581195|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581196|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581197|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581198|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581199|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581200|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581201|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581202|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581203|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581204|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581205|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581206|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581207|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581208|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581209|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581210|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581211|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581212|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581213|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581214|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581215|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581216|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581433|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581217|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581218|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581219|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581220|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581221|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581222|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581223|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581224|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581225|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581226|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581227|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581228|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581229|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581230|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581231|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581232|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581233|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581403|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581234|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581235|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581236|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581237|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581238|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581239|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581240|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581241|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581242|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581243|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581244|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581245|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581246|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581247|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581248|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581249|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581250|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581251|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581252|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581253|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581254|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581255|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581256|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581257|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581258|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581259|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581260|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581261|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581262|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581263|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581404|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581264|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581265|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581266|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581267|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581268|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581269|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581270|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581271|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581272|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581273|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581274|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581275|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581276|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581277|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581278|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581279|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581280|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581281|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581282|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581283|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581284|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581285|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581286|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581287|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581288|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581289|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581290|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581291|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581292|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581293|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581405|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581294|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581295|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581296|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581297|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581298|NCT00943878|E4|Reported Event|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581299|NCT00943878|E3|Reported Event|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
581300|NCT00943878|E2|Reported Event|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
581301|NCT00943878|E1|Reported Event|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
581302|NCT00943917|B16|Baseline|Total|Total of all reporting groups
581303|NCT00943917|B15|Baseline|Ex Inj/ITCA 650 60 Continuation|Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
581304|NCT00943917|B14|Baseline|Ex Inj/ITCA 650 40 Continuation|Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
581305|NCT00943917|B13|Baseline|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
581306|NCT00943917|B12|Baseline|ITCA 650 40/40 Contination|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
581307|NCT00943917|B11|Baseline|ITCA 650 20/40 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
581308|NCT00943917|B10|Baseline|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
581309|NCT00943917|B9|Baseline|Ex Inj/ITCA 650 60 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
581310|NCT00943917|B8|Baseline|Ex Inj/ITCA 650 40 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
581311|NCT00943917|B7|Baseline|ITCA 650 40/80 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
581312|NCT00943917|B6|Baseline|ITCA 650 40/40 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
581313|NCT00943917|B5|Baseline|ITCA 650 20/60- STAGE II|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
581314|NCT00943917|B4|Baseline|ITCA 650 20/20- STAGE II|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
581315|NCT00943917|B3|Baseline|Exenatide Injection- STAGE I|exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
581316|NCT00943917|B2|Baseline|ITCA 650 40 mcg/Day- STAGE I|ITCA 650 40 mcg/day continuous exenatide
581317|NCT00943917|B1|Baseline|ITCA 650 20 mcg/Day- STAGE I|ITCA 650 20 mcg/day continuous exenatide
581318|NCT00943917|P15|Participant Flow|Ex Inj/ITCA 650 60 Continuation|Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
581319|NCT00943917|P14|Participant Flow|Ex Inj/ITCA 650 40 Continuation|Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
581320|NCT00943917|P13|Participant Flow|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
581321|NCT00943917|P12|Participant Flow|ITCA 650 40/40 Contination|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
581322|NCT00943917|P11|Participant Flow|ITCA 650 20/40 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
581323|NCT00943917|P10|Participant Flow|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
581324|NCT00943917|P9|Participant Flow|Ex Inj/ITCA 650 60 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
581325|NCT00943917|P8|Participant Flow|Ex Inj/ITCA 650 40 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
581326|NCT00943917|P7|Participant Flow|ITCA 650 40/80 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
581327|NCT00943917|P6|Participant Flow|ITCA 650 40/40 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
581328|NCT00943917|P5|Participant Flow|ITCA 650 20/60- STAGE II|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
581329|NCT00943917|P4|Participant Flow|ITCA 650 20/20- STAGE II|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
581330|NCT00943917|P3|Participant Flow|Exenatide Injection- STAGE I|exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
581331|NCT00943917|P2|Participant Flow|ITCA 650 40 mcg/Day- STAGE I|ITCA 650 40 mcg/day continuous exenatide
581332|NCT00943917|P1|Participant Flow|ITCA 650 20 mcg/Day- STAGE I|ITCA 650 20 mcg/day continuous exenatide
581333|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
581334|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
581335|NCT00943917|O4|Outcome|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
581336|NCT00943917|O3|Outcome|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
581337|NCT00943917|O2|Outcome|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
581338|NCT00943917|O1|Outcome|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
581339|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Stage II & Stage II Continuation
581340|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Stage II & Stage II Continuation
581341|NCT00943917|O4|Outcome|ITCA 650 40/80|Stage II & Stage II Continuation
581342|NCT00943917|O3|Outcome|ITCA 650 40/40|Stage II & Stage II Continuation
581343|NCT00943917|O2|Outcome|ITCA 650 20/60|Stage II & Stage II Continuation
581344|NCT00943917|O1|Outcome|ITCA 650 20/20|Stage II Continuation
581345|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
581346|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
581347|NCT00943917|O4|Outcome|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
581348|NCT00943917|O3|Outcome|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
581349|NCT00943917|O2|Outcome|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
581350|NCT00943917|O1|Outcome|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
581351|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Stage II & Stage II Continuation
581352|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Stage II & Stage II Continuation
581353|NCT00943917|O4|Outcome|ITCA 650 40/80|Stage II & Stage II Continuation
581354|NCT00943917|O3|Outcome|ITCA 650 40/40|Stage II & Stage II Continuation
581355|NCT00943917|O2|Outcome|ITCA 650 20/60|Stage II & Stage II Continuation
581356|NCT00943917|O1|Outcome|ITCA 650 20/20|Stage II & Stage II Continuation
581357|NCT00943917|O3|Outcome|Exenatide Injection - STAGE I|Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
581358|NCT00943917|O2|Outcome|ITCA 650 40 mcg/Day - STAGE I|ITCA 650 40 mcg/day through Week 12
581359|NCT00943917|O1|Outcome|ITCA 650 20 mcg/Day - STAGE I|ITCA 650 20 mcg/day through Week 12
581360|NCT00943917|O3|Outcome|Exenatide Injection - STAGE I|Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
581361|NCT00943917|O2|Outcome|ITCA 650 40 mcg/Day - STAGE I|ITCA 650 40 mcg/day through Week 12
581362|NCT00943917|O1|Outcome|ITCA 650 20 mcg/Day - STAGE I|ITCA 650 20 mcg/day through Week 12
581363|NCT00943917|E15|Reported Event|Ex Inj/ITCA 650 60 Continutation|Exenatide injection first 12 weeks, then ITCA 650 60 mcg/day through Week 48
581364|NCT00943917|E14|Reported Event|Ex Inj/ITCA 40 Continuation|Exenatide twice/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
581365|NCT00943917|E13|Reported Event|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 80 mcg/day through Week 48
581366|NCT00943917|E12|Reported Event|ITCA 650 40/40 Continuation|ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
581367|NCT00943917|E11|Reported Event|ITCA 650 20/60 Continuation|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 60 mcg/day through Week 48
581368|NCT00943917|E10|Reported Event|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 48
581369|NCT00943917|E9|Reported Event|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
581370|NCT00943917|E8|Reported Event|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
581371|NCT00943917|E7|Reported Event|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
581372|NCT00943917|E6|Reported Event|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
581373|NCT00943917|E5|Reported Event|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
581374|NCT00943917|E4|Reported Event|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
581375|NCT00943917|E3|Reported Event|Exenatide Injection|exenatide injection twice daily dosing: 5 mcg/dose first 4 weeks then 10 mcg/day next 8 weeks
581376|NCT00943917|E2|Reported Event|ITCA 650 40 mcg/Day|ITCA 650 40 mcg/day continuous exenatide
581377|NCT00943917|E1|Reported Event|ITCA 650 20 mcg/Day|ITCA 650 20 mcg/day continuous exenatide
581378|NCT00944021|B6|Baseline|Total|Total of all reporting groups
581379|NCT00944021|B5|Baseline|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
581380|NCT00944021|B4|Baseline|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581381|NCT00944021|B3|Baseline|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581382|NCT00944021|B2|Baseline|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581383|NCT00944021|B1|Baseline|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581384|NCT00944021|P5|Participant Flow|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
581385|NCT00944021|P4|Participant Flow|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581386|NCT00944021|P3|Participant Flow|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581387|NCT00944021|P2|Participant Flow|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581388|NCT00944021|P1|Participant Flow|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581389|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581390|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581391|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581392|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581393|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581394|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581395|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581396|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581397|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581398|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581399|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581400|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581401|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581402|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581406|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581407|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581408|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581409|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
581410|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581411|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581412|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581413|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581414|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
581415|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581416|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581417|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581418|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581419|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
581420|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581421|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581422|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581423|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581424|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
581425|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581426|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581427|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581428|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581429|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
581430|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581431|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581432|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581434|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
581435|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581436|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581437|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581438|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581439|NCT00944021|E5|Reported Event|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
581440|NCT00944021|E4|Reported Event|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
581441|NCT00944021|E3|Reported Event|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
581442|NCT00944021|E2|Reported Event|PA-824 100mg/qd|PA-824 : 100mg oral tablet
581443|NCT00944021|E1|Reported Event|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
581444|NCT00944034|B13|Baseline|Total|Total of all reporting groups
581445|NCT00944034|B12|Baseline|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
581446|NCT00944034|B11|Baseline|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
581447|NCT00944034|B10|Baseline|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
581448|NCT00944034|B9|Baseline|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581449|NCT00944034|B8|Baseline|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581450|NCT00944034|B7|Baseline|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
581451|NCT00944034|B6|Baseline|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
581452|NCT00944034|B5|Baseline|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
581453|NCT00944034|B4|Baseline|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581454|NCT00944034|B3|Baseline|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581455|NCT00944034|B2|Baseline|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581456|NCT00944034|B1|Baseline|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581457|NCT00944034|P12|Participant Flow|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
581458|NCT00944034|P11|Participant Flow|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
582265|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
581459|NCT00944034|P10|Participant Flow|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
581460|NCT00944034|P9|Participant Flow|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581461|NCT00944034|P8|Participant Flow|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581462|NCT00944034|P7|Participant Flow|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
581463|NCT00944034|P6|Participant Flow|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
581464|NCT00944034|P5|Participant Flow|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
581465|NCT00944034|P4|Participant Flow|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581466|NCT00944034|P3|Participant Flow|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581467|NCT00944034|P2|Participant Flow|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581468|NCT00944034|P1|Participant Flow|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.age
581469|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
581470|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
581471|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
581472|NCT00944034|O3|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
581473|NCT00944034|O2|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
581770|NCT00932425|P2|Participant Flow|Control|Patients discharged home with standard clinical follow-up
581474|NCT00944034|O1|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581475|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
581476|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
581477|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
581478|NCT00944034|O9|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581479|NCT00944034|O8|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581480|NCT00944034|O7|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
581481|NCT00944034|O6|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
581482|NCT00944034|O5|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
581483|NCT00944034|O4|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581484|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581485|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581486|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581487|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
581488|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
581489|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
581490|NCT00944034|O8|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
581491|NCT00944034|O7|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
581492|NCT00944034|O6|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581493|NCT00944034|O5|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581494|NCT00944034|O4|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
581573|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581495|NCT00944034|O3|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
581496|NCT00944034|O2|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581497|NCT00944034|O1|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581498|NCT00944034|O4|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
581499|NCT00944034|O3|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
581500|NCT00944034|O2|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581501|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581502|NCT00944034|O9|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581503|NCT00944034|O8|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581504|NCT00944034|O7|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
581505|NCT00944034|O6|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
581506|NCT00944034|O5|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
581507|NCT00944034|O4|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581508|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
582619|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
581509|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581510|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581511|NCT00944034|O3|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581512|NCT00944034|O2|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581513|NCT00944034|O1|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
581514|NCT00944034|O3|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
581515|NCT00944034|O2|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
581516|NCT00944034|O1|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581517|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581518|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581519|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581520|NCT00944034|E12|Reported Event|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
581521|NCT00944034|E11|Reported Event|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
581522|NCT00944034|E10|Reported Event|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
581523|NCT00944034|E9|Reported Event|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581524|NCT00944034|E8|Reported Event|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581525|NCT00944034|E7|Reported Event|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
581526|NCT00944034|E6|Reported Event|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
581527|NCT00944034|E5|Reported Event|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
581528|NCT00944034|E4|Reported Event|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581529|NCT00944034|E3|Reported Event|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
581530|NCT00944034|E2|Reported Event|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
581531|NCT00944034|E1|Reported Event|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
581532|NCT00944073|B3|Baseline|Total|Total of all reporting groups
581533|NCT00944073|B2|Baseline|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581534|NCT00944073|B1|Baseline|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581535|NCT00944073|P2|Participant Flow|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581536|NCT00944073|P1|Participant Flow|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581537|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581538|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581539|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581540|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581541|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581542|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581543|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581544|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581545|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581546|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581547|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581548|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581549|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581550|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581551|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581552|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581553|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581554|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581555|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581556|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581557|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581558|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581559|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581560|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581561|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581562|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581563|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581564|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581565|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581566|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581567|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581568|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581569|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581570|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581571|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581572|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
582589|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
581574|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581575|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581576|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581577|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581578|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581579|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581580|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581581|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581582|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581583|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581584|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581585|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581586|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581587|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581588|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581589|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581590|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581591|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
582620|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
581592|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581593|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581594|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581595|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581596|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581597|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581598|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581599|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581600|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581601|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581602|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581603|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581604|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581605|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581606|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581607|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581608|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581609|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581610|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581611|NCT00944073|E2|Reported Event|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581612|NCT00944073|E1|Reported Event|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
581613|NCT00944125|B1|Baseline|All Study Participants|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Randomized to Arm A: Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months. Randomized to Arm B: Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
581614|NCT00944125|P2|Participant Flow|BiV Pacing First, Then Dual Site LV Pacing, Then Physician Dis|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
581615|NCT00944125|P1|Participant Flow|Dual Site LV Pacing First, Then BiV Pacing, Then Physician Dis|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months."
581616|NCT00944125|O2|Outcome|BiV Pacing|
581617|NCT00944125|O1|Outcome|Dual Site LV Pacing|
581618|NCT00944125|E2|Reported Event|BiV Pacing|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
581619|NCT00944125|E1|Reported Event|Dual Site LV Pacing|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months."
581620|NCT00944229|B1|Baseline|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
581621|NCT00944229|P1|Participant Flow|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
581622|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
581623|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
581624|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
581625|NCT00944229|E1|Reported Event|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
581626|NCT00932321|B3|Baseline|Total|Total of all reporting groups
581627|NCT00932321|B2|Baseline|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
581628|NCT00932321|B1|Baseline|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
581629|NCT00932321|P2|Participant Flow|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
581630|NCT00932321|P1|Participant Flow|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
581631|NCT00932321|O2|Outcome|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
581632|NCT00932321|O1|Outcome|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
581633|NCT00932321|O2|Outcome|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
581634|NCT00932321|O1|Outcome|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
581635|NCT00932321|E2|Reported Event|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
581636|NCT00932321|E1|Reported Event|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
581637|NCT00932373|B12|Baseline|Total|Total of all reporting groups
581638|NCT00932373|B11|Baseline|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
581639|NCT00932373|B10|Baseline|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
581640|NCT00932373|B9|Baseline|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
581641|NCT00932373|B8|Baseline|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
581642|NCT00932373|B7|Baseline|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
581643|NCT00932373|B6|Baseline|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581644|NCT00932373|B5|Baseline|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
581645|NCT00932373|B4|Baseline|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
581646|NCT00932373|B3|Baseline|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
581647|NCT00932373|B2|Baseline|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
581648|NCT00932373|B1|Baseline|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
581649|NCT00932373|P11|Participant Flow|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
581650|NCT00932373|P10|Participant Flow|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
581651|NCT00932373|P9|Participant Flow|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
581652|NCT00932373|P8|Participant Flow|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
581653|NCT00932373|P7|Participant Flow|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
581654|NCT00932373|P6|Participant Flow|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581655|NCT00932373|P5|Participant Flow|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
581656|NCT00932373|P4|Participant Flow|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
581657|NCT00932373|P3|Participant Flow|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
581821|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
581658|NCT00932373|P2|Participant Flow|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
581659|NCT00932373|P1|Participant Flow|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
581660|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
581661|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
581662|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
581663|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
581664|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
581665|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581666|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
581667|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
581668|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
581669|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
581670|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
581671|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
581672|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
581673|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
581674|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
581675|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
581676|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581677|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
581678|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
581679|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
581680|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
581681|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
581682|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
581683|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
581684|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
581685|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
581686|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
581687|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581688|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
581689|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
581690|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
581691|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
581692|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
581693|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 Every Weeks|Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
581694|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581695|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
581696|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
581697|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
581698|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
581699|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
581700|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581701|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
581702|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
581703|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
581704|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
581705|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
581706|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 Every Weeks|Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
581707|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581708|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
581709|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
581710|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
581711|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
581712|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
581713|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581714|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
581715|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
581716|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
581717|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
581718|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
581719|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
581720|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
581721|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
581722|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
581723|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
581724|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
581725|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
581726|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
581727|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
581728|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
581729|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
581730|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581731|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
581732|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
581733|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
581734|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
581735|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
581736|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
581737|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
581738|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
581739|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
581740|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
581741|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581742|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
581743|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
581744|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
581745|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
581746|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
581747|NCT00932373|E11|Reported Event|Trastuzumab-MCC-DM 2.9 mg/kg Weekly|2.9 mg/kg administered intravenously (IV) once a week
581748|NCT00932373|E10|Reported Event|Trastuzumab-MCC-DM 2.4 mg/kg Weekly|Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once a week
581749|NCT00932373|E9|Reported Event|Trastuzumab-MCC-DM 2.0 mg/kg Weekly|Trastuzumab-MCC-DM 2.0 mg/kg administered intravenously (IV) once a week
581750|NCT00932373|E8|Reported Event|Trastuzumab-MCC-DM 1.6 mg/kg Weekly|Trastuzumab-MCC-DM 1.6 mg/kg administered intravenously (IV) once a week
581751|NCT00932373|E7|Reported Event|Trastuzumab-MCC-DM 1.2 mg/kg Weekly|Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once a week
581752|NCT00932373|E6|Reported Event|Trastuzumab-MCC-DM 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 4.8 mg/kg administered intravenously (IV) once every 3 weeks
581753|NCT00932373|E5|Reported Event|Trastuzumab-MCC-DM 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 3.6 mg/kg administered intravenously (IV) once every 3 weeks
581754|NCT00932373|E4|Reported Event|Trastuzumab-MCC-DM 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once every 3 weeks
581755|NCT00932373|E3|Reported Event|Trastuzumab-MCC-DM 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once every 3 weeks
581756|NCT00932373|E2|Reported Event|Trastuzumab-MCC-DM 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 0.6 mg/kg administered intravenously (IV) once every 3 weeks
581757|NCT00932373|E1|Reported Event|Trastuzumab-MCC-DM 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 0.3 mg/kg administered intravenously (IV) once every 3 weeks
581758|NCT00932399|B3|Baseline|Total|Total of all reporting groups
581759|NCT00932399|B2|Baseline|Group 2|No history of lower limb amputation
581760|NCT00932399|B1|Baseline|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
581761|NCT00932399|P2|Participant Flow|Group 2|No history of lower limb amputation
581762|NCT00932399|P1|Participant Flow|Group 1|Underwent a procedure at a VA medical facility in Veterans Integrated Service Network #20 for a lower limb amputation between 1997 and 2008
581763|NCT00932399|O2|Outcome|Group 2|No history of lower limb amputation
581764|NCT00932399|O1|Outcome|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
581765|NCT00932399|E2|Reported Event|Group 2|No history of lower limb amputation
581766|NCT00932399|E1|Reported Event|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
581767|NCT00932425|B3|Baseline|Total|Total of all reporting groups
581768|NCT00932425|B2|Baseline|Control|Patients discharged home with standard clinical follow-up
581769|NCT00932425|B1|Baseline|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days
Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
581771|NCT00932425|P1|Participant Flow|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days
Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
581772|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days
Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
581773|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
581774|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days
Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
581775|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
581776|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days
Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
581777|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
581778|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days
Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
581779|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
581780|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days
Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
581781|NCT00932425|E2|Reported Event|Control|Patients discharged home with standard clinical follow-up
581782|NCT00932425|E1|Reported Event|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days
Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
581783|NCT00932451|B1|Baseline|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581784|NCT00932451|P1|Participant Flow|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581785|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581786|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581787|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581788|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581822|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
581789|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581790|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581791|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581792|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581793|NCT00932451|O2|Outcome|Crizotinib 250 mg BID-ALT Controls|Participants were administered crizotinib at a starting dose of 250 milligram [mg] orally, twice daily (BID) on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581794|NCT00932451|O1|Outcome|Crizotinib 250 mg BID-ALT Cases|Participants were administered crizotinib at a starting dose of 250 milligram [mg] orally, twice daily (BID) on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581795|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581796|NCT00932451|O2|Outcome|PF-06260182|PF-06260182 was a PF-02341066 metabolite measured in this study.
581797|NCT00932451|O1|Outcome|Crizotinib (PF-02341066)|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581798|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581799|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581879|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581800|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581801|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581802|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581803|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581804|NCT00932451|E1|Reported Event|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
581805|NCT00932477|B1|Baseline|All Study Participants|All Study Participants
581806|NCT00932477|P6|Participant Flow|Sequence CBA|Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1
581807|NCT00932477|P5|Participant Flow|Sequence CAB|Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2
581808|NCT00932477|P4|Participant Flow|Sequence BCA|Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1
581809|NCT00932477|P3|Participant Flow|Sequence BAC|Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
581810|NCT00932477|P2|Participant Flow|Sequence ACB|Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2
581811|NCT00932477|P1|Participant Flow|Sequence ABC|Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
581812|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
581813|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
581814|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
581815|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
581816|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
581817|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
581818|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
581819|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
581820|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
582762|NCT00950599|B2|Baseline|Saxagliptin 5 mg (0-40 mg Cohort)|
581823|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
581824|NCT00932477|E3|Reported Event|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
581825|NCT00932477|E2|Reported Event|Artificial Tear Formulation 2|Formulation 2 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
581826|NCT00932477|E1|Reported Event|Artificial Tear Formulation 1|Formulation 1 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
581827|NCT00932620|B3|Baseline|Total|Total of all reporting groups
581828|NCT00932620|B2|Baseline|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
581829|NCT00932620|B1|Baseline|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
581830|NCT00932620|P2|Participant Flow|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
581831|NCT00932620|P1|Participant Flow|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
581832|NCT00932620|O2|Outcome|Simvastatin/Ezetimibe 10/10|
581833|NCT00932620|O1|Outcome|Simvastatin 40|
581834|NCT00932620|O2|Outcome|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
581835|NCT00932620|O1|Outcome|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
581836|NCT00932620|E2|Reported Event|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
581837|NCT00932620|E1|Reported Event|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
581838|NCT00932646|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
581839|NCT00932646|P4|Participant Flow|Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
581840|NCT00932646|P3|Participant Flow|Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
581841|NCT00932646|P2|Participant Flow|Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5mcg qd in the first period, Foradil 12 mcg bid in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
581842|NCT00932646|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
581843|NCT00932646|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581844|NCT00932646|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581845|NCT00932646|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581846|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
581847|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581848|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581849|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581850|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
581851|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581852|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581853|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581854|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
581855|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581856|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581857|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581858|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
581859|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581860|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581861|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581862|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
581863|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581864|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581865|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581866|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
581867|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581868|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581869|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581870|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
581871|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581872|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581873|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581874|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
581875|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581876|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581877|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581878|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
581880|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581881|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581882|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
581883|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581884|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581885|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581886|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
581887|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581888|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581889|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581890|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
581891|NCT00932646|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
581892|NCT00932646|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
581893|NCT00932646|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
581894|NCT00932646|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
581895|NCT00932659|B1|Baseline|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias
continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
581896|NCT00932659|P1|Participant Flow|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias
continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
581897|NCT00932659|O1|Outcome|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias
continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
581898|NCT00932659|O1|Outcome|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias
continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
581899|NCT00932659|E1|Reported Event|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias
continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
581900|NCT00932893|B3|Baseline|Total|Total of all reporting groups
581901|NCT00932893|B2|Baseline|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581902|NCT00932893|B1|Baseline|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581903|NCT00932893|P2|Participant Flow|Chemotherapy|Pemetrexed 500 mg per square meter (mg/m^2) intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581904|NCT00932893|P1|Participant Flow|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581905|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581906|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581907|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581908|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581909|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581910|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581974|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
581975|NCT00938548|E2|Reported Event|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
581911|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581912|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581913|NCT00932893|O1|Outcome|Overall Values|Overall assessment for complete response, partial response, stable disease, progressive disease and early death
581914|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581915|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581916|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581917|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581918|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581919|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581920|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581921|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581922|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581923|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581924|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581925|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
582099|NCT00938717|E1|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
581926|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581927|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581928|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581929|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581930|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581931|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581932|NCT00932893|E2|Reported Event|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581933|NCT00932893|E1|Reported Event|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
581976|NCT00938548|E1|Reported Event|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
581977|NCT00938639|B3|Baseline|Total|Total of all reporting groups
582621|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
581934|NCT00938457|B1|Baseline|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581935|NCT00938457|P1|Participant Flow|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581936|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581937|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581938|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581939|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581940|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581941|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581942|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581943|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581944|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581945|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581946|NCT00938457|E1|Reported Event|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
581947|NCT00938470|B3|Baseline|Total|Total of all reporting groups
582100|NCT00938782|B3|Baseline|Total|Total of all reporting groups
581948|NCT00938470|B2|Baseline|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
581949|NCT00938470|B1|Baseline|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
581950|NCT00938470|P2|Participant Flow|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
581951|NCT00938470|P1|Participant Flow|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
581952|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
581978|NCT00938639|B2|Baseline|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581953|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
581954|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
581955|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
581956|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
581957|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
581958|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
581959|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
581960|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
581961|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
582259|NCT00948818|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
581962|NCT00938470|E2|Reported Event|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
581963|NCT00938470|E1|Reported Event|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
581964|NCT00938548|B3|Baseline|Total|Total of all reporting groups
581965|NCT00938548|B2|Baseline|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
581966|NCT00938548|B1|Baseline|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
581967|NCT00938548|P2|Participant Flow|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
581968|NCT00938548|P1|Participant Flow|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
581969|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
581970|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
581971|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
581972|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
581973|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
582789|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
581979|NCT00938639|B1|Baseline|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581980|NCT00938639|P2|Participant Flow|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581981|NCT00938639|P1|Participant Flow|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581982|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581983|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581984|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581985|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581986|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581987|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581988|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581989|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581990|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581991|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581992|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581993|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581994|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581995|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581996|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581997|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581998|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
581999|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582000|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582001|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582002|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582003|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582004|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582005|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582006|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582007|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582008|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582009|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582010|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582011|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582012|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582013|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582014|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582015|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582016|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582060|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
582017|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582018|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582019|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582020|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582021|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582022|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582023|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582024|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582025|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582026|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582027|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582028|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582029|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582030|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582031|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582032|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582033|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582034|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582035|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582036|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582037|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582038|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582039|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582040|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582041|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582042|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582043|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582044|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582045|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582046|NCT00938639|E2|Reported Event|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582047|NCT00938639|E1|Reported Event|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
582048|NCT00938704|B3|Baseline|Total|Total of all reporting groups
582049|NCT00938704|B2|Baseline|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
582050|NCT00938704|B1|Baseline|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
582051|NCT00938704|P2|Participant Flow|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
582052|NCT00938704|P1|Participant Flow|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
582053|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
582054|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
582055|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
582056|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
582057|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
582058|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
582059|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
582062|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
582063|NCT00938704|E2|Reported Event|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
582064|NCT00938704|E1|Reported Event|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
582065|NCT00938717|B3|Baseline|Total|Total of all reporting groups
582066|NCT00938717|B2|Baseline|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582067|NCT00938717|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
582068|NCT00938717|P2|Participant Flow|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582069|NCT00938717|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
582070|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582071|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582072|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582073|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582074|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582075|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582076|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582077|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582078|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582079|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582080|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582081|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582082|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582083|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582084|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582085|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582086|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582087|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582088|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582089|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582090|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582091|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582092|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582093|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582094|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582095|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582096|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582097|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582098|NCT00938717|E2|Reported Event|Linaclotide|Linaclotide 290μg, oral administration, once per day.
582763|NCT00950599|B1|Baseline|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582101|NCT00938782|B2|Baseline|2 - CONTROL Group|"Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.
Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was not based on SEDLine™ data (CONTROL group)"
582102|NCT00938782|B1|Baseline|1 - SEDLine™ Group|"Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.
Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was based on SEDLine™ data (SEDLine™ group)."
582103|NCT00938782|P2|Participant Flow|2- Control Group|Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.
582104|NCT00938782|P1|Participant Flow|1 - SEDLine™ Group|Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.
582105|NCT00938782|O2|Outcome|2 - Control Group|Patient groups randomized to active monitoring versus blinded monitoring. This group had teh clinician blinded to output of the Sedline monitor.
582106|NCT00938782|O1|Outcome|1 - Sedline Group|Patient group randomized to active monitoring with Sedline monitor.
582107|NCT00938782|E2|Reported Event|Group 2 - Control Group|Patient groups randomized to monitoring with blinded data not used to titrate anesthesia.
582108|NCT00938782|E1|Reported Event|1 - SEDLine Group|Patient groups randomized to active monitoring. This group had Sedline monitor used to titrate anesthesia.
582109|NCT00944450|B1|Baseline|All Participants|
582110|NCT00944450|P2|Participant Flow|100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous|100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
582111|NCT00944450|P1|Participant Flow|100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate|Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
582112|NCT00944450|O2|Outcome|100 mg MK0431 Monohydrate|100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
582113|NCT00944450|O1|Outcome|100 mg MK0431 Anhydrous|100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
582622|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582114|NCT00944450|O2|Outcome|100 mg MK0431 Monohydrate|100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
582115|NCT00944450|O1|Outcome|100 mg MK0431 Anhydrous|100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
582116|NCT00944450|E2|Reported Event|100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous|100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
582117|NCT00944450|E1|Reported Event|100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate|Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
582118|NCT00944554|B3|Baseline|Total|Total of all reporting groups
582119|NCT00944554|B2|Baseline|Varenicline|"Experimental group given varenicline dosing.
Varenicline: Varenicline and placebo given twice a day or five weeks."
582120|NCT00944554|B1|Baseline|Placebo|"Group given placebo.
Placebo: Varenicline and placebo given twice a day or five weeks."
582121|NCT00944554|P2|Participant Flow|Varenicline|Experimental group given varenicline twice a day or five weeks.
582122|NCT00944554|P1|Participant Flow|Placebo|Group given placebo twice a day for 5 weeks.
582123|NCT00944554|O2|Outcome|Varenicline|Experimental group given varenicline twice a day or five weeks.
582124|NCT00944554|O1|Outcome|Placebo|Group given placebo twice a day or five weeks.
582125|NCT00944554|E2|Reported Event|Varenicline|"Experimental group given varenicline dosing.
Varenicline: Varenicline and placebo given twice a day or five weeks."
582126|NCT00944554|E1|Reported Event|Placebo|"Group given placebo.
Placebo: Varenicline and placebo given twice a day or five weeks."
582127|NCT00948389|B6|Baseline|Total|Total of all reporting groups
582128|NCT00948389|B5|Baseline|Dose Level 3B|Dasatinib: 100 mg/day (QD) + CCNU: 90 mg/m²
582129|NCT00948389|B4|Baseline|Dose Level 3A|Dasatinib: 150 mg/day (100 mg AM and 50 mg PM) + CCNU: 90 mg/m²
582130|NCT00948389|B3|Baseline|Dose Level 2|Dasatinib: 100 mg BID + CCNU: 90 mg/m²
582131|NCT00948389|B2|Baseline|Dose Level 1B|Dasatinib: 100 mg QD / 100mg BID + CCNU: 90 mg/m²
582132|NCT00948389|B1|Baseline|Dose Level 1A|Dasatinib: 100 mg once daily (QD) cycle 1 / 100 mg twice daily (BID) cycle 2 + lomustine (CCNU): 110 mg/m²
582133|NCT00948389|P5|Participant Flow|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
582134|NCT00948389|P4|Participant Flow|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
582135|NCT00948389|P3|Participant Flow|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
582136|NCT00948389|P2|Participant Flow|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2.
582137|NCT00948389|P1|Participant Flow|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
582138|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
582139|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
582140|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
582141|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
582260|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582826|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582142|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2
582143|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
582144|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
582145|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
582146|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
582147|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
582148|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
582149|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
582150|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
582151|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
582152|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
582153|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
582154|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
582155|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
582156|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
582157|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
582623|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582158|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
582159|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
582160|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
582161|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
582162|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
582163|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
582164|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
582165|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
582166|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
582167|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
582168|NCT00948389|E5|Reported Event|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
582169|NCT00948389|E4|Reported Event|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
582170|NCT00948389|E3|Reported Event|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
582171|NCT00948389|E2|Reported Event|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
582172|NCT00948389|E1|Reported Event|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
582173|NCT00948441|B3|Baseline|Total|Total of all reporting groups
582174|NCT00948441|B2|Baseline|Group 2|Heparin x12 weeks; washout x4 weeks; 25% ethanol x 12 weeks
582175|NCT00948441|B1|Baseline|Group 1|25% ethanol x12 weeks; washout x4 weeks; heparin x12 weeks
582176|NCT00948441|P2|Participant Flow|Heparin Lock/Washout/25% Ethanol|First Heparin lock, then washout period, then 25% ethanol lock
582177|NCT00948441|P1|Participant Flow|25% Ethanol/Washout/Heparin|First 25% ethanol, then Washout, then heparin
582178|NCT00948441|O2|Outcome|Heparin Lock|"Heparin
heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours."
582179|NCT00948441|O1|Outcome|Ethanol Lock|"25% ethanol
25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
582180|NCT00948441|O2|Outcome|Infections While Using Heparin Lock|"Heparin lock x 12 weeks
heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution was instilled and allowed to dwell for 4 to 12 hours."
582827|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582181|NCT00948441|O1|Outcome|Infections While Using Ethanol Lock|"25% ethanol x 12 weeks
25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
582182|NCT00948441|E2|Reported Event|Heparin Lock|"Heparin
heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours."
582183|NCT00948441|E1|Reported Event|Ethanol Lock|"25% ethanol
25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
582184|NCT00948506|B3|Baseline|Total|Total of all reporting groups
582185|NCT00948506|B2|Baseline|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
582186|NCT00948506|B1|Baseline|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
582187|NCT00948506|P2|Participant Flow|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
582188|NCT00948506|P1|Participant Flow|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
582189|NCT00948506|O2|Outcome|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
582190|NCT00948506|O1|Outcome|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
582191|NCT00948506|O3|Outcome|Placebo|Subjects received placebo to one side of the face in a split-face design (1% or 3% cidofovir was applied to the other side of the face).
582192|NCT00948506|O2|Outcome|3% Cidofovir|Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
582193|NCT00948506|O1|Outcome|1% Cidofovir|Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
582194|NCT00948506|E2|Reported Event|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
582195|NCT00948506|E1|Reported Event|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
582196|NCT00948675|B3|Baseline|Total|Total of all reporting groups
582197|NCT00948675|B2|Baseline|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
582198|NCT00948675|B1|Baseline|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
582199|NCT00948675|P2|Participant Flow|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
582200|NCT00948675|P1|Participant Flow|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
582201|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
582202|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
582203|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
582204|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
582205|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
582828|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582206|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
582207|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
582208|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
582209|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
582210|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
582211|NCT00948675|E2|Reported Event|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
582233|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
582624|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582212|NCT00948675|E1|Reported Event|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
582213|NCT00948688|B1|Baseline|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
582214|NCT00948688|P2|Participant Flow|Vorinostat 100 mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
582215|NCT00948688|P1|Participant Flow|Vorinostat 200 mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
582216|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
582217|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
582218|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
582219|NCT00948688|O2|Outcome|Vorinostat 100 mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
582220|NCT00948688|O1|Outcome|Vorinostat 200 mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
582221|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
582261|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582262|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582263|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582264|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582222|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
582223|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
582224|NCT00948688|E2|Reported Event|Vorinostat 100mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
582225|NCT00948688|E1|Reported Event|Vorinostat 200mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)during each week of radiation therapy
582226|NCT00948766|B3|Baseline|Total|Total of all reporting groups
582227|NCT00948766|B2|Baseline|Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
582228|NCT00948766|B1|Baseline|Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
582229|NCT00948766|P2|Participant Flow|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
582230|NCT00948766|P1|Participant Flow|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
582231|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
582232|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
582234|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
582235|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
582236|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
582237|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
582238|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
582239|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
582240|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
582241|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
582242|NCT00948766|E3|Reported Event|Extension Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
582243|NCT00948766|E2|Reported Event|Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
582244|NCT00948766|E1|Reported Event|Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
582245|NCT00948792|B1|Baseline|Short and Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or two hours (long).
582246|NCT00948792|P1|Participant Flow|Short and Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or 2 hours (long).
582247|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
582248|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
582249|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
582250|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
582251|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
582252|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
582253|NCT00948792|E2|Reported Event|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
582254|NCT00948792|E1|Reported Event|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
582255|NCT00948818|B3|Baseline|Total|Total of all reporting groups
582256|NCT00948818|B2|Baseline|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582257|NCT00948818|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
582258|NCT00948818|P2|Participant Flow|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582266|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582267|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582268|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582269|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582270|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582271|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582272|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582273|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582274|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582275|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582276|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582277|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582278|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582279|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582280|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582281|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582282|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582283|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582284|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582285|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582286|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
582287|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
582288|NCT00948818|E5|Reported Event|Linaclotide to Linaclotide - Randomized Withdrawal Period|Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period
582416|NCT00949650|O1|Outcome|Afatinib 20mg q.d.|Patients receiving Afatinib monotherapy 20mg once daily (q.d.)after a dose reduction.
582289|NCT00948818|E4|Reported Event|Linaclotide to Placebo - Randomized Withdrawal Period|"Dose-matched placebo, oral administration, once per day during a 4-week randomized withdrawal period.
This group had previously received linaclotide 290µg, oral administration, once per day during the 12-week treatment period."
582290|NCT00948818|E3|Reported Event|Placebo to Linaclotide - Randomized Withdrawal Period|"Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period.
This group had previously received dose-matched placebo during the 12-week randomized treatment period."
582291|NCT00948818|E2|Reported Event|Linaclotide - Treatment Period|Linaclotide 290µg, oral administration, once per day.
582292|NCT00948818|E1|Reported Event|Placebo - Treatment Period|Dose-matched placebo, oral administration, once per day.
582293|NCT00948857|B3|Baseline|Total|Total of all reporting groups
582294|NCT00948857|B2|Baseline|Blinded Placebo|Blinded placebo
582295|NCT00948857|B1|Baseline|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
582296|NCT00948857|P2|Participant Flow|Blinded Placebo|Blinded placebo
582297|NCT00948857|P1|Participant Flow|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
582298|NCT00948857|O2|Outcome|Placebo|Blinded placebo
582299|NCT00948857|O1|Outcome|DHEA|Dehydroepiandrosterone 25 mg tid po
582300|NCT00948857|E2|Reported Event|Blinded Placebo|Blinded placebo
582301|NCT00948857|E1|Reported Event|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
582302|NCT00948896|B9|Baseline|Total|Total of all reporting groups
582303|NCT00948896|B8|Baseline|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582304|NCT00948896|B7|Baseline|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582305|NCT00948896|B6|Baseline|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582306|NCT00948896|B5|Baseline|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
582307|NCT00948896|B4|Baseline|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582308|NCT00948896|B3|Baseline|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582309|NCT00948896|B2|Baseline|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582310|NCT00948896|B1|Baseline|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
582311|NCT00948896|P8|Participant Flow|HIV-exposed & DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582312|NCT00948896|P7|Participant Flow|HIV-exposed & TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582313|NCT00948896|P6|Participant Flow|HIV-exposed & SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582314|NCT00948896|P5|Participant Flow|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
582315|NCT00948896|P4|Participant Flow|HIV-unexposed & DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582316|NCT00948896|P3|Participant Flow|HIV-unexposed & TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582317|NCT00948896|P2|Participant Flow|HIV-unexposed & SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582318|NCT00948896|P1|Participant Flow|HIV-unexposed & No Chemoprevention|HIV-unexposed No chemoprevention was given
582319|NCT00948896|O4|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582320|NCT00948896|O3|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582321|NCT00948896|O2|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582322|NCT00948896|O1|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
582323|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582324|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582325|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582326|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
582327|NCT00948896|O8|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582328|NCT00948896|O7|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582329|NCT00948896|O6|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582330|NCT00948896|O5|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
582331|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582332|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582333|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582334|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
582335|NCT00948896|O8|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582336|NCT00948896|O7|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582337|NCT00948896|O6|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582338|NCT00948896|O5|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
582339|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582340|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582341|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582342|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
582343|NCT00948896|E8|Reported Event|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582344|NCT00948896|E7|Reported Event|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582345|NCT00948896|E6|Reported Event|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582346|NCT00948896|E5|Reported Event|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
582347|NCT00948896|E4|Reported Event|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
582348|NCT00948896|E3|Reported Event|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
582349|NCT00948896|E2|Reported Event|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
582350|NCT00948896|E1|Reported Event|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
582351|NCT00949078|B3|Baseline|Total|Total of all reporting groups
582352|NCT00949078|B2|Baseline|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582353|NCT00949078|B1|Baseline|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582354|NCT00949078|P2|Participant Flow|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582355|NCT00949078|P1|Participant Flow|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582356|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582378|NCT00949117|B1|Baseline|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582586|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582357|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582358|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582359|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582360|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582361|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582362|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582363|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582625|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582364|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582365|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582366|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582367|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582368|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582369|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582370|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582371|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582372|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582373|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582374|NCT00949078|E2|Reported Event|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582375|NCT00949078|E1|Reported Event|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
582376|NCT00949117|B3|Baseline|Total|Total of all reporting groups
582377|NCT00949117|B2|Baseline|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582829|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582379|NCT00949117|P2|Participant Flow|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582380|NCT00949117|P1|Participant Flow|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582381|NCT00949117|O2|Outcome|Cyproheptadine HCl & PediaSure or Ensure|"Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Ensure: Given orally
PediaSure: Given orally
cyproheptadine hydrochloride: Given orally"
582382|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
cyproheptadine hydrochloride: Given orally"
582383|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582384|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582385|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582386|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582387|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582388|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582389|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582390|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582391|NCT00949117|E2|Reported Event|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582392|NCT00949117|E1|Reported Event|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
582393|NCT00949533|B3|Baseline|Total|Total of all reporting groups
582394|NCT00949533|B2|Baseline|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
582395|NCT00949533|B1|Baseline|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
582396|NCT00949533|P2|Participant Flow|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
582397|NCT00949533|P1|Participant Flow|Standard Dose|Oseltamivir (Tamiflu) capsule was administered orally at a dose of 75 milligrams (mg) twice a day (BID) in adult participants and children received oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter [mg/mL]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
582398|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
582399|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
582400|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
582401|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
582402|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
582403|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
582503|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582587|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582404|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
582405|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
582406|NCT00949533|E2|Reported Event|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
582407|NCT00949533|E1|Reported Event|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
582408|NCT00949650|B3|Baseline|Total|Total of all reporting groups
582409|NCT00949650|B2|Baseline|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582410|NCT00949650|B1|Baseline|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582411|NCT00949650|P2|Participant Flow|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582412|NCT00949650|P1|Participant Flow|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582413|NCT00949650|O4|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib monotherapy 50mg once daily (q.d.)after a dose escalation.
582414|NCT00949650|O3|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582415|NCT00949650|O2|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib monotherapy 30mg once daily (q.d.)after a dose reduction.
582417|NCT00949650|O4|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib monotherapy 50mg once daily (q.d.)after a dose escalation.
582418|NCT00949650|O3|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582419|NCT00949650|O2|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib monotherapy 30mg once daily (q.d.)after a dose reduction.
582420|NCT00949650|O1|Outcome|Afatinib 20mg q.d.|Patients receiving Afatinib monotherapy 20mg once daily (q.d.)after a dose reduction.
582421|NCT00949650|O4|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib monotherapy 50mg once daily (q.d.)after a dose escalation.
582422|NCT00949650|O3|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582423|NCT00949650|O2|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib monotherapy 30mg once daily (q.d.)after a dose reduction.
582424|NCT00949650|O1|Outcome|Afatinib 20mg q.d.|Patients receiving Afatinib monotherapy 20mg once daily (q.d.)after a dose reduction.
582425|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582426|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582427|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582428|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582429|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582430|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582431|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582432|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582433|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582434|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582435|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582436|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582437|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582438|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582439|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582440|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582441|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582442|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582443|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582444|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582445|NCT00949650|E2|Reported Event|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
582446|NCT00949650|E1|Reported Event|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
582588|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582447|NCT00949702|B1|Baseline|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582448|NCT00949702|P1|Participant Flow|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582449|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582450|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582451|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582452|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582453|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582454|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582455|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582790|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582456|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582457|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582458|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582459|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582460|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582461|NCT00949702|E1|Reported Event|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
582462|NCT00949715|B3|Baseline|Total|Total of all reporting groups
582463|NCT00949715|B2|Baseline|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582464|NCT00949715|B1|Baseline|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582465|NCT00949715|P2|Participant Flow|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582466|NCT00949715|P1|Participant Flow|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582467|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582468|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582504|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582505|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582469|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582470|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582471|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582472|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582473|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582520|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582474|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
582475|NCT00949715|E1|Reported Event|No Subjects|No subjects had adverse events or death collected as part of this study.
582476|NCT00949884|B4|Baseline|Total|Total of all reporting groups
582477|NCT00949884|B3|Baseline|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582478|NCT00949884|B2|Baseline|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
582479|NCT00949884|B1|Baseline|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582480|NCT00949884|P3|Participant Flow|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582481|NCT00949884|P2|Participant Flow|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
582482|NCT00949884|P1|Participant Flow|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582483|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582484|NCT00949884|O2|Outcome|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
582485|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582486|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582487|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582488|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582489|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582490|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582491|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582492|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582493|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582494|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582495|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582496|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582497|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582498|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582499|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582500|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582501|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582502|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582506|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582507|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582508|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582509|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582510|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582511|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582512|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582513|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582514|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582515|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582516|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582517|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582518|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582519|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582521|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582522|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582523|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582524|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582525|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582526|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582527|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582528|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582529|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
582530|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582531|NCT00949884|E3|Reported Event|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
582532|NCT00949884|E2|Reported Event|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
582533|NCT00949884|E1|Reported Event|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
582534|NCT00949910|B1|Baseline|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
582535|NCT00949910|P1|Participant Flow|Erlotinib|Erlotinib was given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC). Participants were treated with 150 milligrams (mg) oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
582536|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
582537|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
582582|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582583|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582584|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582585|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582538|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
582539|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
582540|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
582541|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
582609|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582610|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582611|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582791|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582542|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
582543|NCT00949910|E1|Reported Event|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
582544|NCT00949975|B5|Baseline|Total|Total of all reporting groups
582545|NCT00949975|B4|Baseline|Placebo|Matched Placebo Tablets
582546|NCT00949975|B3|Baseline|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582547|NCT00949975|B2|Baseline|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582548|NCT00949975|B1|Baseline|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582549|NCT00949975|P4|Participant Flow|Placebo|Matched Placebo Tablets
582550|NCT00949975|P3|Participant Flow|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582551|NCT00949975|P2|Participant Flow|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582552|NCT00949975|P1|Participant Flow|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582553|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582554|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582555|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582556|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582557|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582558|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582559|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582560|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582561|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582562|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582563|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582564|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582565|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582566|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582567|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582568|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582569|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582570|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582571|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582572|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582573|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582574|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582575|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582576|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582577|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582578|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582579|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582580|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582581|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582590|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582591|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582592|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582593|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582594|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582595|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582596|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582597|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582598|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582599|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582600|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582601|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582602|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582603|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582604|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582605|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582606|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582607|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582608|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582626|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582627|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582628|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582629|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582630|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582631|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582632|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582633|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582634|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582635|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582636|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582637|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582638|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582639|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582640|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582641|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582642|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582643|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582644|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582645|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582646|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582647|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582648|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582649|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582650|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582651|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582652|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582653|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582654|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582655|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582656|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582657|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582658|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582659|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582660|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582661|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
582662|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582663|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582664|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582665|NCT00949975|E4|Reported Event|Placebo|Matched Placebo Tablets
582666|NCT00949975|E3|Reported Event|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
582667|NCT00949975|E2|Reported Event|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
582668|NCT00949975|E1|Reported Event|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
582669|NCT00950183|B1|Baseline|Foot and Ankle Surgery|Our target enrollment was 82 participants. We only enrolled 36 participants. The study was terminated due to low enrollment. As a result, patients were never randomized.
582670|NCT00950183|P1|Participant Flow|Foot and Ankle Surgery|
582671|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
582672|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
582673|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
582674|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
582675|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
582676|NCT00950183|E1|Reported Event|Foot and Ankle Surgery|
582677|NCT00950235|B3|Baseline|Total|Total of all reporting groups
582678|NCT00950235|B2|Baseline|Weight Management Counseling|"In-person and group session counseling
Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
582679|NCT00950235|B1|Baseline|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group
Usual Care: Standard nutrition counseling from Health Plan"
582680|NCT00950235|P2|Participant Flow|Weight Management Counseling|"In-person and group session counseling
Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
582681|NCT00950235|P1|Participant Flow|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group
Usual Care: Standard nutrition counseling from Health Plan"
582682|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling
Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
582683|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group
Usual Care: Standard nutrition counseling from Health Plan"
582684|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling
Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
582685|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group
Usual Care: Standard nutrition counseling from Health Plan"
582686|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling
Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
582687|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group
Usual Care: Standard nutrition counseling from Health Plan"
582688|NCT00950235|E2|Reported Event|Weight Management Counseling|"In-person and group session counseling
Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
582689|NCT00950235|E1|Reported Event|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group
Usual Care: Standard nutrition counseling from Health Plan"
582690|NCT00950300|B3|Baseline|Total|Total of all reporting groups
582691|NCT00950300|B2|Baseline|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582692|NCT00950300|B1|Baseline|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582830|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582693|NCT00950300|P2|Participant Flow|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-milligram (mg) fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582694|NCT00950300|P1|Participant Flow|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 milligrams per meter-squared (mg/m^2) every 21 days for four cycles followed by 5-fluorouracil 500 mg/m^2, epirubicin 75 mg/m^2, and cyclophosphamide 500 mg/m^2 (FEC) every 21 days for four cycles. Herceptin was administered as 8 milligrams per kilogram (mg/kg) on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the Treatment-Free Follow-Up (TFFU) Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the Survival Follow-Up (SFU) Period.
582695|NCT00950300|O1|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582696|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582742|NCT00950300|E4|Reported Event|Herceptin SC (Adjuvant)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The ten cycles of Herceptin SC after surgery were collectively considered the Adjuvant Treatment Period, defined as the time from surgery until 35 days after last dose of study drug. Adverse events were followed from surgery until up to 28 days after last dose of Herceptin.
582697|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582698|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582699|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582700|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582701|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582702|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582703|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582704|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582705|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582777|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582778|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582706|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582707|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582708|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582709|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582710|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582831|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582832|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582711|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582712|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582713|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582714|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582715|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582716|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582717|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582718|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582719|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582833|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582834|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582720|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582721|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582722|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582723|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582724|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582725|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582726|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582727|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582728|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582835|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582836|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582729|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582730|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582731|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582732|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582733|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582734|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582735|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582736|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582737|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
582837|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582838|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582738|NCT00950300|E8|Reported Event|Herceptin SC (SFU)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period. All adverse events were followed for up to 28 days after last dose as applicable.
582739|NCT00950300|E7|Reported Event|Herceptin IV (SFU)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period. All adverse events were followed for up to 28 days after last dose as applicable.
582740|NCT00950300|E6|Reported Event|Herceptin SC (TFFU)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. After completion, participants entered the TFFU Period. All adverse events were followed for up to 28 days after last dose, and treatment-related and cardiac adverse events were followed until withdrawal from study. (All serious adverse events were followed for 6 months after last dose regardless of treatment relationship.)
582741|NCT00950300|E5|Reported Event|Herceptin IV (TFFU)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. After completion, participants entered the TFFU Period. All adverse events were followed for up to 28 days after last dose, and treatment-related and cardiac adverse events were followed until withdrawal from study. (All serious adverse events were followed for 6 months after last dose regardless of treatment relationship.)
582779|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582780|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582781|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582782|NCT00950599|O2|Outcome|Placebo (0 & 100 Cohort)|
582783|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582784|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582743|NCT00950300|E3|Reported Event|Herceptin IV (Adjuvant)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The ten cycles of Herceptin IV after surgery were collectively considered the Adjuvant Treatment Period, defined as the time from surgery until 35 days after last dose of study drug. Adverse events were followed from surgery until up to 28 days after last dose of Herceptin.
582744|NCT00950300|E2|Reported Event|Herceptin SC (Neoadjuvant)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery were collectively considered the Neoadjuvant Treatment Period, defined as the time from first dose until the date of surgery. Adverse events were followed from Baseline until up to 28 days after last dose of Herceptin.
582745|NCT00950300|E1|Reported Event|Herceptin IV (Neoadjuvant)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery were collectively considered the Neoadjuvant Treatment Period, defined as the time from first dose until the date of surgery. Adverse events were followed from Baseline until up to 28 days after last dose of Herceptin.
582746|NCT00950352|B3|Baseline|Total|Total of all reporting groups
582747|NCT00950352|B2|Baseline|Placebo|"32 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.
Placebo: Subjects were given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group."
582748|NCT00950352|B1|Baseline|Citicoline|"74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.
Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks."
582749|NCT00950352|P2|Participant Flow|Placebo|"32 subjects with methamphetamine dependence were treated with placebo for 8-9 weeks.
Placebo: Subjects were given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group."
582750|NCT00950352|P1|Participant Flow|Citicoline|"74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.
Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks."
582751|NCT00950352|O2|Outcome|Placebo|Subjects will be given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
582752|NCT00950352|O1|Outcome|Citicoline|Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.
582753|NCT00950352|E2|Reported Event|Placebo|
582754|NCT00950352|E1|Reported Event|Citicoline|
582755|NCT00950599|B9|Baseline|Total|Total of all reporting groups
582756|NCT00950599|B8|Baseline|Placebo (0 & 100 mg Cohort)|
582757|NCT00950599|B7|Baseline|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582758|NCT00950599|B6|Baseline|Placebo (0-40 mg Cohort)|
582759|NCT00950599|B5|Baseline|Saxagliptin 40 mg (0-40 mg Cohort)|
582760|NCT00950599|B4|Baseline|Saxagliptin 20 mg (0-40 mg Cohort)|
582761|NCT00950599|B3|Baseline|Saxagliptin 10 mg (0-40 mg Cohort)|
582764|NCT00950599|P10|Participant Flow|Saxa 0 & 100 mg Cohort (Follow-up Period)|The follow-up period is 4 weeks and includes: subjects completing 6 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
582765|NCT00950599|P9|Participant Flow|Saxa 0-40 mg Cohort (Follow-up Period)|The follow-up period is 4 weeks and includes: subjects completing 12 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
582766|NCT00950599|P8|Participant Flow|Placebo (0 & 100 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
582767|NCT00950599|P7|Participant Flow|Saxagliptin 100 mg (0 & 100 mg Cohort)|The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
582768|NCT00950599|P6|Participant Flow|Placebo (0-40 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
582769|NCT00950599|P5|Participant Flow|Saxagliptin 40 mg (0-40 mg Cohort)|The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
582770|NCT00950599|P4|Participant Flow|Saxagliptin 20 mg (0-40 mg Cohort)|The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
582771|NCT00950599|P3|Participant Flow|Saxagliptin 10 mg (0-40 mg Cohort)|The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
582772|NCT00950599|P2|Participant Flow|Saxagliptin 5 mg (0-40 mg Cohort)|The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
582773|NCT00950599|P1|Participant Flow|Saxagliptin 2.5 mg (0-40 mg Cohort)|The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
582774|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
582775|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582776|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582792|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582793|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582794|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582795|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582796|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582797|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582798|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
582799|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582800|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
582801|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582802|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
582803|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582804|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
582805|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582806|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
582807|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582808|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
582809|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582810|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582811|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582812|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582813|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582814|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582815|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582816|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582817|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582818|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582819|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582820|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582821|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582822|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582823|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582824|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582825|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582839|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582840|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582841|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582842|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582843|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582844|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582845|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582846|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582847|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582848|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582849|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582850|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582851|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582852|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582853|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582854|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582855|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582856|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582857|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582858|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582859|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582860|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582861|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582862|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582863|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582864|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582865|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582866|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582867|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582868|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582869|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582870|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582871|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582872|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582873|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582874|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582875|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582876|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582877|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582878|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582879|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582880|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582881|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582882|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582883|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582884|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582885|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582886|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582887|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582888|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582889|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582890|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582891|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582892|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582893|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582894|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582895|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582896|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582897|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582898|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582899|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582900|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582901|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582902|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582903|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582904|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582905|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582906|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582907|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582908|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582909|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582910|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582911|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582912|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582913|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582914|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582915|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582916|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582917|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582918|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582919|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582920|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582921|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582922|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582923|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582924|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582925|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582926|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582927|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582928|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582929|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582930|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582931|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582932|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582933|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582934|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582935|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582936|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582937|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582938|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582939|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582940|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582941|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582942|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582943|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582944|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582945|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582946|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582947|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582948|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582949|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582950|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582951|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582952|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582953|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582954|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582955|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582956|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582957|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582958|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582959|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582960|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582961|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582962|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582963|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582964|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582965|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582966|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582967|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582968|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582969|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582970|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582971|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582972|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582973|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582974|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582975|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582976|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582977|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582978|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582979|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582980|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582981|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582982|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582983|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582984|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582985|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582986|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582987|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582988|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582989|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582990|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
582991|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
582992|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582993|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
582994|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
582995|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
582996|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
582997|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
582998|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
582999|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583000|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583001|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583002|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583003|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583004|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583005|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583006|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583007|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583008|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583009|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583010|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583011|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583012|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583013|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583014|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583015|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583016|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583017|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583018|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583019|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583020|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583021|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583022|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583023|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583024|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583025|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583026|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583027|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583028|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583029|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583030|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583031|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583032|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583033|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583034|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583035|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583036|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583037|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583038|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583039|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583040|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583041|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583042|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583043|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583044|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583045|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583046|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583047|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583048|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583049|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583050|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583051|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583052|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583053|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583054|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583055|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583056|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583057|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583058|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583059|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583060|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583061|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583062|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583063|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583064|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583065|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583066|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583067|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583068|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583069|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583070|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583071|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583072|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583073|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583074|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583075|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583076|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583077|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583078|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583079|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583080|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583081|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583082|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583083|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583084|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583085|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583086|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583087|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583088|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583089|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583090|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583091|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583092|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583093|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583094|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583095|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583096|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583097|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583098|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583099|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583100|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583101|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583102|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583103|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583104|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583105|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583106|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583107|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583108|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583109|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583110|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583111|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583112|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583113|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583114|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583115|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583116|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583117|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583118|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583119|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583120|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583121|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583122|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583123|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583124|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583125|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583126|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583127|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583128|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583129|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583130|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583131|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583132|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583133|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583134|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583135|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583136|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583137|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583138|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583139|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583140|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583141|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583142|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583143|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583144|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583145|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583146|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583147|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583148|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583149|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583150|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583151|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583152|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583153|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583154|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583155|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583156|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583157|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583158|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583159|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583160|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583161|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583162|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583163|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583164|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583165|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583166|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583167|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583168|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583169|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583170|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583171|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583172|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583173|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583174|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583175|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583176|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583177|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583178|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583179|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583180|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583181|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583182|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583183|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583184|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583185|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583186|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583187|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583188|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583189|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583190|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583191|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583192|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583193|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583194|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583195|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583196|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583197|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583198|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583199|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583200|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583201|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583202|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583203|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583204|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583205|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583206|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583207|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583208|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583209|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583210|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583211|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583212|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583213|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583214|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583215|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583216|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583217|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583218|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583219|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583220|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583221|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583222|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583223|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583224|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583225|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583226|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583227|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583228|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583229|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583230|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583231|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583232|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583233|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583234|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583235|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583236|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583237|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583238|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583239|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583240|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583241|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583242|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583243|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583244|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583245|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583246|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583247|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583248|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583249|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583250|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583251|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583252|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583253|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583254|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583255|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583256|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583257|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583258|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583259|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583260|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583261|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583262|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583263|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583264|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583265|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583266|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583267|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583268|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583269|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583270|NCT00950599|O8|Outcome|Placebo (0, 100 mg Cohort)|
583271|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0, 100 mg Cohort)|
583272|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583273|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583274|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583275|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583276|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583277|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583278|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583279|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583280|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583281|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583282|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583283|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583284|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583285|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583286|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583287|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583288|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583289|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583290|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583291|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583292|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583293|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583294|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583295|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583296|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583297|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583298|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583299|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583300|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583301|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583302|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583303|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583304|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583305|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583306|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
583307|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
583308|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583309|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583310|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583311|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583312|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583313|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583314|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583315|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583316|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583317|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583318|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583319|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583320|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
583321|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
583322|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
583323|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
583324|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
583325|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
583326|NCT00950599|E8|Reported Event|Placebo (0-40 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
583327|NCT00950599|E7|Reported Event|Placebo (0 & 100 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
583328|NCT00950599|E6|Reported Event|Saxagliptin 5 mg (0-40 mg Cohort)|The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
583329|NCT00950599|E5|Reported Event|Saxagliptin 40 mg (0-40 mg Cohort)|The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
583330|NCT00950599|E4|Reported Event|Saxagliptin 20 mg (0-40 mg Cohort)|The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
583331|NCT00950599|E3|Reported Event|Saxagliptin 2.5 mg (0-40 mg Cohort)|The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
583332|NCT00950599|E2|Reported Event|Saxagliptin 100 mg (0 & 100 mg Cohort)|The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
583333|NCT00950599|E1|Reported Event|Saxagliptin 10 mg (0-40 mg Cohort)|The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
583334|NCT00950612|B3|Baseline|Total|Total of all reporting groups
583335|NCT00950612|B2|Baseline|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583336|NCT00950612|B1|Baseline|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583337|NCT00950612|P2|Participant Flow|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583338|NCT00950612|P1|Participant Flow|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583339|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583340|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583341|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583342|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583343|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583422|NCT00950664|B3|Baseline|Total|Total of all reporting groups
583344|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583345|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583346|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583347|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583348|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583349|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583350|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583351|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583352|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583353|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583354|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583355|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583356|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583357|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583358|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583359|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583360|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583361|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583362|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583363|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583364|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583365|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583366|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583367|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583368|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583369|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583370|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583371|NCT00950612|E2|Reported Event|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
583372|NCT00950612|E1|Reported Event|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
583373|NCT00950651|B3|Baseline|Total|Total of all reporting groups
583423|NCT00950664|B2|Baseline|Botox® First, Then Dysport®|Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
583374|NCT00950651|B2|Baseline|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583375|NCT00950651|B1|Baseline|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583376|NCT00950651|P2|Participant Flow|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583377|NCT00950651|P1|Participant Flow|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583378|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583379|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583380|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583381|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583382|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583383|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583384|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583385|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583386|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583387|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583388|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583514|NCT00941668|O2|Outcome|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
583389|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583390|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583391|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583392|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583393|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583394|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583395|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583396|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583397|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583398|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583399|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583400|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583401|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583402|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583403|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583404|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583405|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583406|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583407|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583408|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583409|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583410|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583411|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583412|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583775|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
583413|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583414|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583415|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583416|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583417|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583418|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583419|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583420|NCT00950651|E2|Reported Event|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583421|NCT00950651|E1|Reported Event|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
583424|NCT00950664|B1|Baseline|Dysport® First, Then Botox®|Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)
583425|NCT00950664|P2|Participant Flow|Botox® First, Then Dysport®|Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
583426|NCT00950664|P1|Participant Flow|Dysport® First, Then Botox®|Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)
583427|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
583428|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
583429|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
583430|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
583431|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
583432|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
583433|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
583434|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
583435|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
583436|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
583437|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
583438|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
583439|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
583440|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
583441|NCT00950664|E2|Reported Event|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
583442|NCT00950664|E1|Reported Event|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
583443|NCT00950690|B1|Baseline|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
583444|NCT00950690|P1|Participant Flow|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
583445|NCT00950690|O1|Outcome|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
583446|NCT00950690|O1|Outcome|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
583447|NCT00950690|E1|Reported Event|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
583448|NCT00950729|B1|Baseline|Healthy Subjects|
583449|NCT00950729|P1|Participant Flow|Healthy Subjects|
583450|NCT00950729|O1|Outcome|Healthy Subjects|
583451|NCT00950729|O1|Outcome|Healthy Subjects|
583452|NCT00950729|E1|Reported Event|Healthy Subjects|
583453|NCT00950742|B3|Baseline|Total|Total of all reporting groups
583454|NCT00950742|B2|Baseline|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
583515|NCT00941668|O1|Outcome|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
583455|NCT00950742|B1|Baseline|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
583456|NCT00950742|P2|Participant Flow|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
583457|NCT00950742|P1|Participant Flow|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
583458|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
583459|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
583460|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
583461|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
583462|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
583463|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
583539|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
584016|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
583464|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
583465|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
583466|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
583467|NCT00950742|O1|Outcome|Afatinib|All patients received both Afatinib and Herceptin. Dose level 1 was continuous daily dosing with Afatinib 20mg tablets and once weekly an intravenous infusion of Herceptin. Dose level 2 was continuous daily dosing with Afatinib 30mg tablets and once weekly an intravenous infusion of Herceptin. Cycle length was 28 days.
583468|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
583469|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.
583470|NCT00950742|E2|Reported Event|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression.
583471|NCT00950742|E1|Reported Event|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression.
583472|NCT00950755|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583473|NCT00950755|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583516|NCT00941668|E2|Reported Event|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
583517|NCT00941668|E1|Reported Event|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
583518|NCT00941681|B4|Baseline|Total|Total of all reporting groups
583519|NCT00941681|B3|Baseline|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
583474|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583475|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583476|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583477|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583540|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
583541|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
584338|NCT00953147|E2|Reported Event|Ciclesonide HFA 160 Mcg Once Daily|
583478|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583479|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583480|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583481|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583482|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583520|NCT00941681|B2|Baseline|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
583776|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
583483|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583484|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583485|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583486|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583498|NCT00941655|B1|Baseline|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.
Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
584339|NCT00953147|E1|Reported Event|Ciclesonide HFA 80 Mcg Once Daily|
583487|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583488|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583489|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583490|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583491|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583492|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583493|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583494|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583495|NCT00950755|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
583496|NCT00941655|B3|Baseline|Total|Total of all reporting groups
583497|NCT00941655|B2|Baseline|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
583499|NCT00941655|P2|Participant Flow|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
583500|NCT00941655|P1|Participant Flow|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.
Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
583501|NCT00941655|O1|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
583502|NCT00941655|O2|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
583503|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.
Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
583504|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.
Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
583505|NCT00941655|E2|Reported Event|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
583506|NCT00941655|E1|Reported Event|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.
Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
583507|NCT00941668|B3|Baseline|Total|Total of all reporting groups
583508|NCT00941668|B2|Baseline|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
583509|NCT00941668|B1|Baseline|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
583510|NCT00941668|P2|Participant Flow|Colgate Great Regular Flavor (Placebo)|sodium monofluorophosphate toothpaste
583511|NCT00941668|P1|Participant Flow|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
583512|NCT00941668|O2|Outcome|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
583513|NCT00941668|O1|Outcome|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
583777|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
583521|NCT00941681|B1|Baseline|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
583522|NCT00941681|P3|Participant Flow|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
583523|NCT00941681|P2|Participant Flow|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
583524|NCT00941681|P1|Participant Flow|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
583525|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
583526|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
583527|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
583528|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
583529|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
583530|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
583531|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
583532|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
583533|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
583534|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
583535|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
583536|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
583537|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
583538|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
585776|NCT00947661|B3|Baseline|Total|Total of all reporting groups
583542|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
583543|NCT00941681|E3|Reported Event|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
583544|NCT00941681|E2|Reported Event|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
583545|NCT00941681|E1|Reported Event|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
583546|NCT00941720|B1|Baseline|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses
cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days
autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
583547|NCT00941720|P1|Participant Flow|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses
cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days
autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
583548|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses
cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days
autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
583549|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses
cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days
autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
583550|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses
cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days
autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
583551|NCT00941720|E1|Reported Event|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses
cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days
autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
583552|NCT00941733|B3|Baseline|Total|Total of all reporting groups
583553|NCT00941733|B2|Baseline|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583554|NCT00941733|B1|Baseline|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583555|NCT00941733|P2|Participant Flow|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583556|NCT00941733|P1|Participant Flow|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583557|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583558|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583559|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583560|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583561|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583562|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583563|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583564|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583565|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583566|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583567|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583568|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583569|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583570|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583571|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583572|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583573|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583574|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583575|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583576|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583577|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583578|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583579|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583580|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583581|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583582|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583583|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583584|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583585|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583586|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583587|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583588|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583589|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583590|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583591|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583592|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583593|NCT00941733|E2|Reported Event|Standard PTA|Standard PTA balloon: Balloon Angioplasty
583594|NCT00941733|E1|Reported Event|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
583636|NCT00950807|E10|Reported Event|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
584017|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
583595|NCT00950807|B1|Baseline|All Study Treatments|"The treatment phase was comprised of three 14-day treatment periods, each separated by a 10-14 day washout period. Participants were randomly assigned to receive a sequence of placebo and 2 of the 9 active treatments :
UMEC 62.5, 125, 250, 500, and 1000 µg QD, UMEC 62.5, 125, and 250 µg BID, tiotropium 18 µg QD."
583596|NCT00950807|P10|Participant Flow|Tiotropium 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
583597|NCT00950807|P9|Participant Flow|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583598|NCT00950807|P8|Participant Flow|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583599|NCT00950807|P7|Participant Flow|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583600|NCT00950807|P6|Participant Flow|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583601|NCT00950807|P5|Participant Flow|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583602|NCT00950807|P4|Participant Flow|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583603|NCT00950807|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583604|NCT00950807|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583605|NCT00950807|P1|Participant Flow|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
583606|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
583607|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583608|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583609|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583610|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583611|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583612|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583613|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583614|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583615|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
583616|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
583617|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583618|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583778|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
583619|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583620|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583621|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583622|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583623|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583624|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583625|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
583626|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
583627|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583628|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583629|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583630|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583631|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583632|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583633|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583634|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583635|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
583637|NCT00950807|E9|Reported Event|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583638|NCT00950807|E8|Reported Event|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583639|NCT00950807|E7|Reported Event|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
583640|NCT00950807|E6|Reported Event|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583641|NCT00950807|E5|Reported Event|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583642|NCT00950807|E4|Reported Event|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583643|NCT00950807|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583644|NCT00950807|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
583645|NCT00950807|E1|Reported Event|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
583646|NCT00950833|B4|Baseline|Total|Total of all reporting groups
583647|NCT00950833|B3|Baseline|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583648|NCT00950833|B2|Baseline|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
583649|NCT00950833|B1|Baseline|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
583650|NCT00950833|P3|Participant Flow|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583709|NCT00950859|P1|Participant Flow|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583710|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583651|NCT00950833|P2|Participant Flow|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
583652|NCT00950833|P1|Participant Flow|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
583653|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583654|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583655|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583656|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583657|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583736|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583658|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583659|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583660|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583661|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583662|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583663|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583664|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583665|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583666|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583667|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583711|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583712|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583668|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583669|NCT00950833|O3|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583670|NCT00950833|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
583671|NCT00950833|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
583672|NCT00950833|O3|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583737|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583738|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583739|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583673|NCT00950833|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
583674|NCT00950833|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
583675|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583676|NCT00950833|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
583677|NCT00950833|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
583678|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583679|NCT00950833|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
583680|NCT00950833|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
583681|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583682|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583683|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583740|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583741|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583742|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583684|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583685|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583686|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583687|NCT00950833|O3|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583688|NCT00950833|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
583689|NCT00950833|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
583690|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583691|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583692|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583693|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583694|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583695|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583696|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583697|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583698|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583743|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583744|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583745|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583699|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583700|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
583701|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583702|NCT00950833|E3|Reported Event|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
583703|NCT00950833|E2|Reported Event|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
583704|NCT00950833|E1|Reported Event|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
583705|NCT00950859|B3|Baseline|Total|Total of all reporting groups
583706|NCT00950859|B2|Baseline|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583707|NCT00950859|B1|Baseline|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583708|NCT00950859|P2|Participant Flow|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583774|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
583713|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583714|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583715|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583716|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583717|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583718|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583719|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583720|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583721|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583722|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583723|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583724|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583725|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583726|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583727|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583728|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583729|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583730|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583731|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583732|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583733|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583734|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583735|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583746|NCT00950859|E2|Reported Event|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
583747|NCT00950859|E1|Reported Event|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
583748|NCT00950872|B1|Baseline|Duet TRS|"Subjects receive Duet TRS
Duet TRS: Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS."
583749|NCT00950872|P1|Participant Flow|Duet TRS|Duet TRS is a staple line buttress
583750|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
583751|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
583752|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
583753|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
583754|NCT00950872|E1|Reported Event|Duet TRS|Duet TRS is a staple line buttress
583755|NCT00950911|B3|Baseline|Total|Total of all reporting groups
583756|NCT00950911|B2|Baseline|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
583757|NCT00950911|B1|Baseline|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
583758|NCT00950911|P2|Participant Flow|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
583759|NCT00950911|P1|Participant Flow|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
583760|NCT00950911|O2|Outcome|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
583761|NCT00950911|O1|Outcome|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
583762|NCT00950911|E2|Reported Event|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
583763|NCT00950911|E1|Reported Event|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
583764|NCT00950937|B3|Baseline|Total|Total of all reporting groups
583765|NCT00950937|B2|Baseline|Control Group|Non HIV-infected persons
583766|NCT00950937|B1|Baseline|HIV Group|HIV infected persons
583767|NCT00950937|P2|Participant Flow|Control Group|Non HIV-infected persons
583768|NCT00950937|P1|Participant Flow|HIV Group|HIV infected persons
583769|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
583770|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
583771|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
583772|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
583773|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
583779|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
583780|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
583781|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
583782|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
583783|NCT00950963|B3|Baseline|Total|Total of all reporting groups
583784|NCT00950963|B2|Baseline|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
583785|NCT00950963|B1|Baseline|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
583786|NCT00950963|P2|Participant Flow|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
583787|NCT00950963|P1|Participant Flow|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
583788|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
583789|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
584014|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
583790|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
583791|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
583792|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
583793|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
583794|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
583795|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
583796|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
583797|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
583798|NCT00950963|E2|Reported Event|Standard Care|"Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
Standard Clinical Care: Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses."
583799|NCT00950963|E1|Reported Event|Phone Counseling|"The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
Phone Counseling: Patient were contacted on a periodic basis via telephone to address there diabetes care."
583800|NCT00951015|B5|Baseline|Total|Total of all reporting groups
583801|NCT00951015|B4|Baseline|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583802|NCT00951015|B3|Baseline|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583803|NCT00951015|B2|Baseline|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583837|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583804|NCT00951015|B1|Baseline|DTG 10 mg OD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583805|NCT00951015|P4|Participant Flow|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583806|NCT00951015|P3|Participant Flow|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583807|NCT00951015|P2|Participant Flow|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583808|NCT00951015|P1|Participant Flow|DTG 10 mg OD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583809|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583810|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583811|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583812|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583813|NCT00951015|O1|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD).
583814|NCT00951015|O1|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)
583815|NCT00951015|O5|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)
583816|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583817|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583818|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583819|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583820|NCT00951015|O5|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)
583821|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583822|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583823|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583824|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583825|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583826|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583827|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583828|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583829|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583830|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583831|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583832|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583833|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583834|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583835|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583836|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583838|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583839|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583840|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583841|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583842|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583843|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583844|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583845|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583846|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583847|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583848|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
584052|NCT00952705|B4|Baseline|Total|Total of all reporting groups
583849|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583850|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583851|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583852|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583853|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583854|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583855|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583856|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583857|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583858|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583859|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583860|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583861|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583862|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583863|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583864|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583865|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583866|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583867|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583868|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583869|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583902|NCT00951093|P1|Participant Flow|Patients Assessed for GERD|Patients assessed for GERD before and after Gastric Bypass Surgery
583870|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583871|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583872|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583873|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583874|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583875|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583876|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583877|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583878|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583879|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583880|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583881|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
592264|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 3 to < 9 years
583882|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583883|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583884|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583885|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583886|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583887|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583888|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583889|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583890|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583891|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583892|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583893|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583894|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583895|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583896|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583897|NCT00951015|E4|Reported Event|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
583898|NCT00951015|E3|Reported Event|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583899|NCT00951015|E2|Reported Event|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583900|NCT00951015|E1|Reported Event|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
583901|NCT00951093|B1|Baseline|Patients Assessed for GERD|Patients who had an open gastric bypass were assessed for GERD before and after surgery.
585352|NCT00946348|E1|Reported Event|Dronabinol|Dronabinol 15 mg
583903|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
583904|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
583905|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
583906|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
583907|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
583908|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
583909|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
583910|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
583911|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
583912|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
583913|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
583914|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
583915|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
583916|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
583917|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
583918|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
583919|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
583920|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
583921|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
583922|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
583923|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
592265|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years
583924|NCT00951093|E1|Reported Event|Patients Assessed for GERD|Patients who had an open gastric bypass were assessed for GERD before and after surgery
583925|NCT00952393|B1|Baseline|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
583926|NCT00952393|P1|Participant Flow|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
583927|NCT00952393|O1|Outcome|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
583928|NCT00952393|E1|Reported Event|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
583929|NCT00952419|B4|Baseline|Total|Total of all reporting groups
583930|NCT00952419|B3|Baseline|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
583931|NCT00952419|B2|Baseline|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583932|NCT00952419|B1|Baseline|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583933|NCT00952419|P3|Participant Flow|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
583934|NCT00952419|P2|Participant Flow|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583935|NCT00952419|P1|Participant Flow|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583936|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
583937|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583938|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583939|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
583940|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583941|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583942|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
583943|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583944|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583945|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
583946|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583947|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
584374|NCT00953407|P5|Participant Flow|Hilafilcon B|Hilafilcon B contact lens
583948|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
583949|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583950|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583951|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
583952|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583953|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583954|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
583955|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583956|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583957|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
583958|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583959|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583960|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
583961|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583962|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583963|NCT00952419|E3|Reported Event|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584015|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
583964|NCT00952419|E2|Reported Event|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583965|NCT00952419|E1|Reported Event|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
583966|NCT00952484|B4|Baseline|Total|Total of all reporting groups
583967|NCT00952484|B3|Baseline|Historical Control|De-identified historical controls selected from a natural history database of patients with HPP.
583968|NCT00952484|B2|Baseline|Asfotase Alfa 3 mg/kg|3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
583969|NCT00952484|B1|Baseline|Asfotase Alfa 2 mg/kg|2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
583970|NCT00952484|P3|Participant Flow|Historical Control|"De-identified historical control patients (i.e., untreated with asfotase alfa) were selected from a longitudinal natural history database of patients with HPP maintained at Shriner’s Hospitals for Children, St. Louis, Missouri.
Historical controls must have had at least two sets of wrist and knee radiographs taken between the ages of 5 years, 0 months and 12 years, 0 months with evidence of open growth plates."
583971|NCT00952484|P2|Participant Flow|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
583972|NCT00952484|P1|Participant Flow|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
583973|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
583974|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
583975|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
583976|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
583977|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
583978|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
583979|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
583980|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
583981|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
583982|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
583983|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
583984|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
583985|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
583986|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
583987|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
583988|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
583989|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
583990|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
584081|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
583991|NCT00952484|O2|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
583992|NCT00952484|O1|Outcome|Historical Controls|De-identified historical controls selected from a natural history database of patients with HPP.
583993|NCT00952484|E2|Reported Event|Asfotase Alfa 3 mg/kg|3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
583994|NCT00952484|E1|Reported Event|Asfotase Alfa 2 mg/kg|2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
583995|NCT00952523|B1|Baseline|Tretinoin & Adapalene-Benzoyl Peroxide|Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
583996|NCT00952523|P1|Participant Flow|Tretinoin & Adapalene-Benzoyl Peroxide|Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
583997|NCT00952523|O2|Outcome|Adapalene-Benzoyl Peroxide Facial Gel|Adapalene 0.1% and Benzoyl peroxide 2.5%
583998|NCT00952523|O1|Outcome|Tretinoin Facial Gel|Tretinoin facial gel in a 0.04% Pump
583999|NCT00952523|E2|Reported Event|Adapalene-Benzoyl Peroxide Facial Gel|Adapalene-Benzoyl Peroxide facial gel applied once daily in a split face model
584000|NCT00952523|E1|Reported Event|Tretinoin Facial Gel|Tretinoin facial gel applied once daily in a split face model
584001|NCT00952588|B3|Baseline|Total|Total of all reporting groups
584002|NCT00952588|B2|Baseline|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
584003|NCT00952588|B1|Baseline|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
584004|NCT00952588|P2|Participant Flow|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
584005|NCT00952588|P1|Participant Flow|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
584006|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
584007|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
584008|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
584009|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
584010|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
584011|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
584012|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
584013|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
584018|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
584019|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
584020|NCT00952588|E2|Reported Event|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
584021|NCT00952588|E1|Reported Event|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
584022|NCT00952614|B1|Baseline|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion
fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
584023|NCT00952614|P1|Participant Flow|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion
fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
584024|NCT00952614|O1|Outcome|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion
fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
584025|NCT00952614|O1|Outcome|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion
fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide
Measure visual acuity improvement from baseline to time periods of 1,2, and 3 years."
584026|NCT00952614|E1|Reported Event|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion
fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
584027|NCT00952653|B1|Baseline|DVS SR 50 mg, Midazolam 4 mg|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584028|NCT00952653|P1|Participant Flow|DVS SR 50 mg, Midazolam 4 mg|Midazolam (MDZ) 4 milligram (mg) syrup (2 mg per milliliter [mg/mL]) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained-release formulation (DVS SR) 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584029|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584030|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
584031|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584032|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
584033|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584034|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
584035|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584036|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
585353|NCT00946478|B3|Baseline|Total|Total of all reporting groups
584037|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584038|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
584039|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584040|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
584041|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584042|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
584043|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584044|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
584045|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584046|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
584047|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584048|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
584049|NCT00952653|E3|Reported Event|DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)|DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
584050|NCT00952653|E2|Reported Event|DVS SR 50 mg (Period 2 / Day 1 to Day 5)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state).
584051|NCT00952653|E1|Reported Event|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
584053|NCT00952705|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
584054|NCT00952705|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
584055|NCT00952705|B1|Baseline|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584056|NCT00952705|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
584057|NCT00952705|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
584058|NCT00952705|P1|Participant Flow|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584059|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
584060|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584061|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
584062|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584063|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
585749|NCT00947531|E2|Reported Event|0.9% Saline Solution|
584064|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584065|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
584066|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584067|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
584068|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584069|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
584070|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584126|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
584071|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
584072|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584073|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
584074|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584075|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
584076|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584077|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
584078|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584079|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
584080|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584082|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584083|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
584084|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584085|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
584086|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584087|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
584127|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
584088|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584089|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
584090|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584091|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
584092|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584093|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
584094|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584095|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
584096|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584097|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
584115|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
584098|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584099|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
584100|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584101|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
584102|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584103|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
584104|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584105|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
584106|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584107|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
584108|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584109|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
584110|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584111|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
584112|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584113|NCT00952705|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
584114|NCT00952705|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
584143|NCT00952822|O4|Outcome|Pediatrics at Least 5 Years of Age - 5 mL|Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=7)
584116|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584117|NCT00952705|E2|Reported Event|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
584118|NCT00952705|E1|Reported Event|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
584119|NCT00952731|B3|Baseline|Total|Total of all reporting groups
584120|NCT00952731|B2|Baseline|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
584121|NCT00952731|B1|Baseline|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
584122|NCT00952731|P2|Participant Flow|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
584123|NCT00952731|P1|Participant Flow|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
584124|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
584125|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
584128|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
584129|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
584130|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
584131|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
584132|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
584133|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
584134|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
584135|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
584136|NCT00952731|E2|Reported Event|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
584137|NCT00952731|E1|Reported Event|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
584138|NCT00952822|B1|Baseline|Treated Participants|Participants who received at least 1 infusion
584139|NCT00952822|P4|Participant Flow|Pediatrics - 5 mL Then 2 mL|Pediatrics - 5 mL then 2 mL: Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 2 mL SWFI for the 2nd PK Evaluation.
584140|NCT00952822|P3|Participant Flow|Pediatrics - 2 mL Then 5 mL|Pediatrics - 2 mL then 5 mL: Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 5 mL SWFI for the 2nd PK Evaluation.
584141|NCT00952822|P2|Participant Flow|Adolescents/Adults - 5 mL Then 2 mL|Adolescents/Adults - 5 mL then 2 mL: Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 2 mL SWFI for the 2nd PK Evaluation.
584142|NCT00952822|P1|Participant Flow|Adolescents/Adults - 2 mL Then 5 mL|Adolescents/Adults - 2 mL then 5 mL: Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 5 mL SWFI for the 2nd PK Evaluation.
584144|NCT00952822|O3|Outcome|Pediatrics at Least 5 Years of Age - 2 mL|Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI (note: 6 hours after infusion n=7)
584145|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=26)
584146|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
584147|NCT00952822|O4|Outcome|Pediatrics - 5 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI
584148|NCT00952822|O3|Outcome|Pediatrics - 2 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI
584149|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
584150|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
584151|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
584152|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
584153|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
584154|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
584155|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
584156|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
584157|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
584158|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
584159|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
584160|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
584161|NCT00952822|O4|Outcome|Pediatrics - 5 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI
584162|NCT00952822|O3|Outcome|Pediatrics - 2 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI
584163|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
584164|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
584165|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
584166|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
584167|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
584168|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
584169|NCT00952822|E2|Reported Event|Pediatrics|Participants aged ≥12 to ≤65 years who received at least one infusion
584170|NCT00952822|E1|Reported Event|Adolescents/Adults|Participants aged ≥12 to ≤65 years who received at least one infusion
584171|NCT00952848|B1|Baseline|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
584172|NCT00952848|P1|Participant Flow|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
584173|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
584174|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
584175|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
584176|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
584177|NCT00952848|E1|Reported Event|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
584178|NCT00953017|B5|Baseline|Total|Total of all reporting groups
584179|NCT00953017|B4|Baseline|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
584180|NCT00953017|B3|Baseline|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584181|NCT00953017|B2|Baseline|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584182|NCT00953017|B1|Baseline|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584183|NCT00953017|P4|Participant Flow|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
585750|NCT00947531|E1|Reported Event|Cerebrolysin|
584184|NCT00953017|P3|Participant Flow|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584185|NCT00953017|P2|Participant Flow|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584186|NCT00953017|P1|Participant Flow|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584187|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
584188|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584189|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584190|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584542|NCT00953849|P2|Participant Flow|Arm 2: Calcitriol|Treatment with Calcitriol
584191|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
584192|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584193|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584194|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584195|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
584196|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584197|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584198|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584199|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
584200|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584201|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584245|NCT00953056|O6|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
584202|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584203|NCT00953017|E4|Reported Event|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
584204|NCT00953017|E3|Reported Event|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584205|NCT00953017|E2|Reported Event|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584206|NCT00953017|E1|Reported Event|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
584207|NCT00953043|B3|Baseline|Total|Total of all reporting groups
584208|NCT00953043|B2|Baseline|Placebo|Subjects randomized to this arm received placebo medication for three days.
584209|NCT00953043|B1|Baseline|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
584210|NCT00953043|P2|Participant Flow|Placebo|Subjects randomized to this arm received placebo medication for three days.
584211|NCT00953043|P1|Participant Flow|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
584212|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
584213|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
584214|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
584215|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
584216|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
584217|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
584218|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
584219|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
584220|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
584221|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
584222|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
584223|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
584224|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
584225|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
584226|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
584227|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
584228|NCT00953043|E2|Reported Event|Placebo|Subjects randomized to this arm received placebo medication for three days.
584229|NCT00953043|E1|Reported Event|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
584230|NCT00953056|B7|Baseline|Total|Total of all reporting groups
584231|NCT00953056|B6|Baseline|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
584232|NCT00953056|B5|Baseline|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
584233|NCT00953056|B4|Baseline|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
584234|NCT00953056|B3|Baseline|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
584235|NCT00953056|B2|Baseline|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
584236|NCT00953056|B1|Baseline|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
584237|NCT00953056|P6|Participant Flow|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
584238|NCT00953056|P5|Participant Flow|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
584239|NCT00953056|P4|Participant Flow|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
584240|NCT00953056|P3|Participant Flow|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
584241|NCT00953056|P2|Participant Flow|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
584242|NCT00953056|P1|Participant Flow|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
584243|NCT00953056|O2|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
584244|NCT00953056|O1|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
584246|NCT00953056|O5|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
584247|NCT00953056|O4|Outcome|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
584248|NCT00953056|O3|Outcome|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
584249|NCT00953056|O2|Outcome|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
584250|NCT00953056|O1|Outcome|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
584251|NCT00953056|O6|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
584252|NCT00953056|O5|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
584253|NCT00953056|O4|Outcome|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
584254|NCT00953056|O3|Outcome|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
584255|NCT00953056|O2|Outcome|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
584256|NCT00953056|O1|Outcome|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
584257|NCT00953056|E6|Reported Event|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
584258|NCT00953056|E5|Reported Event|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
584259|NCT00953056|E4|Reported Event|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
584260|NCT00953056|E3|Reported Event|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
584261|NCT00953056|E2|Reported Event|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
584262|NCT00953056|E1|Reported Event|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
584263|NCT00953121|B4|Baseline|Total|Total of all reporting groups
584296|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584297|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584264|NCT00953121|B3|Baseline|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584265|NCT00953121|B2|Baseline|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584266|NCT00953121|B1|Baseline|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584267|NCT00953121|P3|Participant Flow|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584268|NCT00953121|P2|Participant Flow|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584269|NCT00953121|P1|Participant Flow|Grade IV, No Bevacizumab Failure|"Recurrent Glioblastoma Multiforme (GBM) patients who have not previously failed bevacizumab, irinotecan, or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an area under the curve (AUC) of 4."
584270|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584271|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584272|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584273|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584274|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584275|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584276|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584298|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
592266|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
584277|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584278|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584279|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584280|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584281|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584282|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584283|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584284|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584375|NCT00953407|P4|Participant Flow|Omafilcon A|Omafilcon A contact lens
584285|NCT00953121|E3|Reported Event|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584286|NCT00953121|E2|Reported Event|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584287|NCT00953121|E1|Reported Event|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin
bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
584288|NCT00953147|B4|Baseline|Total|Total of all reporting groups
584289|NCT00953147|B3|Baseline|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584290|NCT00953147|B2|Baseline|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584291|NCT00953147|B1|Baseline|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584292|NCT00953147|P3|Participant Flow|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584293|NCT00953147|P2|Participant Flow|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584294|NCT00953147|P1|Participant Flow|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584295|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584299|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584300|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584301|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584302|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584303|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584304|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584305|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584306|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584307|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584308|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584309|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584310|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584311|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584312|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584313|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584314|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584315|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584316|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584317|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584318|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584319|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584320|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584373|NCT00953407|B1|Baseline|Nelfilcon A|Nelfilcon A spherical contact lens worn on a daily wear, daily disposable basis
584321|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584322|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584323|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584324|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584325|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584326|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584327|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584328|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584329|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584330|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584331|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584332|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584333|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584334|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
584335|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
584336|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
584337|NCT00953147|E3|Reported Event|Placebo Once Daily|
584340|NCT00953160|B1|Baseline|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
584341|NCT00953160|P1|Participant Flow|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
584342|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
584343|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
584344|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
584345|NCT00953160|E1|Reported Event|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
584346|NCT00953225|B3|Baseline|Total|Total of all reporting groups
584347|NCT00953225|B2|Baseline|Placebo|"Placebo daily for one year
Placebo daily for one year: Placebo"
584348|NCT00953225|B1|Baseline|Vitamin D3|"4,000 IU vitamin D3 daily for one year
vitamin D3: 4,000 IU daily for one year"
584349|NCT00953225|P2|Participant Flow|Placebo|"Placebo daily for one year
Placebo daily for one year: Placebo"
584350|NCT00953225|P1|Participant Flow|Vitamin D3|"4,000 IU vitamin D3 daily for one year
vitamin D3: 4,000 IU daily for one year"
584351|NCT00953225|O2|Outcome|Placebo|"Placebo daily for one year
Placebo daily for one year: Placebo"
584352|NCT00953225|O1|Outcome|Vitamin D3|"4,000 IU vitamin D3 daily for one year
vitamin D3: 4,000 IU daily for one year"
584353|NCT00953225|O2|Outcome|Placebo|"Placebo daily for one year
Placebo daily for one year: Placebo"
584354|NCT00953225|O1|Outcome|Vitamin D3|"4,000 IU vitamin D3 daily for one year
vitamin D3: 4,000 IU daily for one year"
584355|NCT00953225|E2|Reported Event|Arm 2|"Placebo daily for one year
Placebo daily for one year: Placebo"
584356|NCT00953225|E1|Reported Event|Arm 1|"4,000 IU vitamin D3 daily for one year
vitamin D3: 4,000 IU daily for one year"
584357|NCT00953290|B1|Baseline|Treated And Untreated Thigh|Treated and untreated arms (left and right thighs) on the same subject.
584358|NCT00953290|P1|Participant Flow|Treated and Untreated Thigh|Circumference measurement of RF treated thigh compared to untreated thigh (average of 2.8 treatments and average dosage of 27 kJ) on the same subject
584359|NCT00953290|O1|Outcome|Treated and Untreated Mid Thigh|Treated and untreated arms (left and right thigh) on the same subject
584360|NCT00953290|O1|Outcome|Treated Thigh|
584361|NCT00953290|O1|Outcome|Treated and Untreated Thigh|
584362|NCT00953290|O1|Outcome|Treated and Untreated Upper Thigh|Treated and untreated arms (left and right thigh) on the same participant
584363|NCT00953290|E1|Reported Event|Treated Thigh|
584364|NCT00953329|B1|Baseline|Group 1|
584365|NCT00953329|P1|Participant Flow|Alefacept Treated|
584366|NCT00953329|O1|Outcome|Alefacept|50 mg
584367|NCT00953329|E1|Reported Event|Group 1|
584368|NCT00953407|B6|Baseline|Total|Total of all reporting groups
584369|NCT00953407|B5|Baseline|Hilafilcon B|Hilafilcon B spherical contact lens worn on a daily wear, daily disposable basis
584370|NCT00953407|B4|Baseline|Omafilcon A|Omafilcon A spherical contact lens worn on a daily wear, daily disposable basis
584371|NCT00953407|B3|Baseline|Etafilcon A|Etafilcon A spherical contact lens worn on a daily wear, daily disposable basis
584372|NCT00953407|B2|Baseline|Narafilcon A|Narafilcon A spherical contact lens worn on a daily wear, daily disposable basis
584376|NCT00953407|P3|Participant Flow|Etafilcon A|Etafilcon A contact lens
584377|NCT00953407|P2|Participant Flow|Narafilcon A|Narafilcon A contact lens
584378|NCT00953407|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lens
584379|NCT00953407|O5|Outcome|Hilafilcon B|Hilafilcon B contact lens
584380|NCT00953407|O4|Outcome|Omafilcon A|Omafilcon A contact lens
584381|NCT00953407|O3|Outcome|Etafilcon A|Etafilcon A contact lens
584382|NCT00953407|O2|Outcome|Narafilcon A|Narafilcon A contact lens
584383|NCT00953407|O1|Outcome|Nelfilcon A|Nelfilcon A contact lens
584384|NCT00953407|E5|Reported Event|Hilafilcon B|Hilafilcon B contact lens
584385|NCT00953407|E4|Reported Event|Omafilcon A|Omafilcon A contact lens
584386|NCT00953407|E3|Reported Event|Etafilcon A|Etafilcon A contact lens
584387|NCT00953407|E2|Reported Event|Narafilcon A|Narafilcon A contact lens
584388|NCT00953407|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lens
584389|NCT00953524|B5|Baseline|Total|Total of all reporting groups
584390|NCT00953524|B4|Baseline|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584391|NCT00953524|B3|Baseline|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584392|NCT00953524|B2|Baseline|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
584393|NCT00953524|B1|Baseline|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584394|NCT00953524|P4|Participant Flow|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584395|NCT00953524|P3|Participant Flow|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584396|NCT00953524|P2|Participant Flow|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
584397|NCT00953524|P1|Participant Flow|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
592267|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years
584398|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584399|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584400|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
584401|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584402|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584403|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584404|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
584405|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584406|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584407|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584408|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
584409|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584410|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584411|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584412|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
584413|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584414|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584415|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584416|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
584417|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584418|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584419|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584420|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
584421|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584422|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584423|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584424|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
584425|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584426|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584427|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584428|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
584429|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584430|NCT00953524|E4|Reported Event|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
584431|NCT00953524|E3|Reported Event|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584432|NCT00953524|E2|Reported Event|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
584433|NCT00953524|E1|Reported Event|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
584434|NCT00953615|B1|Baseline|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
584435|NCT00953615|P1|Participant Flow|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
584436|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
584437|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
584438|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
584439|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
584440|NCT00953615|E1|Reported Event|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
584441|NCT00953654|B4|Baseline|Total|Total of all reporting groups
584442|NCT00953654|B3|Baseline|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
584443|NCT00953654|B2|Baseline|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
584444|NCT00953654|B1|Baseline|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
584445|NCT00953654|P3|Participant Flow|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
584446|NCT00953654|P2|Participant Flow|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
584447|NCT00953654|P1|Participant Flow|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
584448|NCT00953654|O3|Outcome|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
584449|NCT00953654|O2|Outcome|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
584450|NCT00953654|O1|Outcome|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
584451|NCT00953654|O3|Outcome|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
584452|NCT00953654|O2|Outcome|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
584453|NCT00953654|O1|Outcome|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
584454|NCT00953654|E3|Reported Event|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
584455|NCT00953654|E2|Reported Event|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
584456|NCT00953654|E1|Reported Event|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
584562|NCT00953849|E2|Reported Event|Arm 2: Calcitriol|oral cancer patients receiving Calcitriol prior to surgery
584457|NCT00953667|B1|Baseline|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
584458|NCT00953667|P1|Participant Flow|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
584459|NCT00953667|O1|Outcome|Niacin/Endotoxin|Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
584460|NCT00953667|O1|Outcome|Niacin/Endotoxin|Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
584461|NCT00953667|E1|Reported Event|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
584462|NCT00953680|B1|Baseline|All Participants|All randomized patients
584463|NCT00953680|P2|Participant Flow|Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet|Single dose losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
584464|NCT00953680|P1|Participant Flow|Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule|Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
584465|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
584466|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
584467|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
584468|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
584469|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
584470|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
584471|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
584472|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
584473|NCT00953680|E2|Reported Event|Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet|losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
584474|NCT00953680|E1|Reported Event|Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule|Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
584475|NCT00953706|B3|Baseline|Total|Total of all reporting groups
584476|NCT00953706|B2|Baseline|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584477|NCT00953706|B1|Baseline|Placebo – Part A|Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
584478|NCT00953706|P4|Participant Flow|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584479|NCT00953706|P3|Participant Flow|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584480|NCT00953706|P2|Participant Flow|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584481|NCT00953706|P1|Participant Flow|Placebo – Part A|Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
584482|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584483|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584484|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584485|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584486|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584487|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584488|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584489|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584490|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584491|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584563|NCT00953849|E1|Reported Event|Arm 1: Celecoxib|oral cancer patients receiving Celecoxib prior to surgery
584492|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584493|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584494|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584495|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584496|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584497|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584498|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584499|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584500|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584501|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584502|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584503|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584504|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584505|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584506|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584507|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584543|NCT00953849|P1|Participant Flow|Arm 1: Celecoxib|Treatment with Celecoxib
584508|NCT00953706|E4|Reported Event|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584509|NCT00953706|E3|Reported Event|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
584510|NCT00953706|E2|Reported Event|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584511|NCT00953706|E1|Reported Event|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
584512|NCT00953719|B3|Baseline|Total|Total of all reporting groups
584513|NCT00953719|B2|Baseline|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control
28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
584514|NCT00953719|B1|Baseline|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner
36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
584515|NCT00953719|P2|Participant Flow|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control
28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
584516|NCT00953719|P1|Participant Flow|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner
36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
584517|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control
28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
584518|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner
36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
584519|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control
28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
584520|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner
36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
584521|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control
28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
584522|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner
36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
584523|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control
28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
584524|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner
36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
584525|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control
28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
584949|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584526|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner
36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
584527|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control
28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
584528|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner
36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
584529|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control
28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
584530|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner
36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
584531|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control
28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
584532|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner
36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
584533|NCT00953719|E2|Reported Event|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control
28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
584534|NCT00953719|E1|Reported Event|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner
36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
584535|NCT00953849|B5|Baseline|Total|Total of all reporting groups
584536|NCT00953849|B4|Baseline|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
584537|NCT00953849|B3|Baseline|Arm 3: Celecoxib Plus Calcitriol|Celecoxib + Calcitriol 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg 1,25-dihydroxyvitamin D3) for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)
584538|NCT00953849|B2|Baseline|Arm 2: Calcitriol|Calcitriol Calcitriol (1,25-dihydroxyvitamin D3): 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment)
584539|NCT00953849|B1|Baseline|Arm 1: Celecoxib|"Celecoxib:
Celecoxib (400 mg twice daily) oral cancer patients receiving new immunotherapy prior to surgery"
584540|NCT00953849|P4|Participant Flow|Arm 4: No Treatment|no treatment prior to surgery
584541|NCT00953849|P3|Participant Flow|Arm 3: Celecoxib Plus Calcitriol|Treatment with Celecoxib + Calcitriol
584544|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
584545|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery
1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
584546|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery
celecoxib: celecoxib (400 mg twice daily)"
584547|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery
1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
584548|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
584549|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery
1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
584550|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery
celecoxib: celecoxib (400 mg twice daily)"
584551|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery
1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
584552|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
584553|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery
1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
584554|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery
celecoxib: celecoxib (400 mg twice daily)"
584555|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery
1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
584556|NCT00953849|O4|Outcome|Arm 4: No Treatment|no treatment prior to surgery
584557|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"Treatment with Celecoxib plus Calcitriol prior to surgery.
Celecoxib plus Calcitriol: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)"
584558|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"Treatment with Calcitriol prior to surgery
Calcitriol: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol 3 for each of 3 sequential days followed by 4 days of no treatment)"
584559|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"Celecoxib treatment prior to surgery
Celecoxib: Celecoxib (400 mg twice daily)"
584560|NCT00953849|E4|Reported Event|Arm 4: No Treatment|oral cancer patients receiving no treatment prior to surgery
584561|NCT00953849|E3|Reported Event|Arm 3: Celecoxib Plus Calcitriol|oral cancer patients receiving Celecoxib + Calcitriol prior to surgery
584564|NCT00953862|B1|Baseline|Treatment|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.
Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
584565|NCT00953862|P1|Participant Flow|Atomoxetine Arm|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.
Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
584566|NCT00953862|O1|Outcome|Atomoxetine Arm|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.
Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
584596|NCT00954122|B1|Baseline|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
584567|NCT00953862|O1|Outcome|Atomoxetine Phase|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.
Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
584568|NCT00953862|O1|Outcome|Atomoxetine Arm|Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline. Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.
584569|NCT00953862|E1|Reported Event|Treatment Phase|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.
Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
584570|NCT00953927|B3|Baseline|Total|Total of all reporting groups
584571|NCT00953927|B2|Baseline|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
584572|NCT00953927|B1|Baseline|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
584573|NCT00953927|P2|Participant Flow|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
584574|NCT00953927|P1|Participant Flow|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
584575|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
584576|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
584577|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
584950|NCT00945100|O1|Outcome|Control|2 hours daily patching
584578|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
584579|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
584580|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
584581|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
584582|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
584583|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
584584|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
584585|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
584586|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
584587|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
584588|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
584589|NCT00953927|E2|Reported Event|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
584590|NCT00953927|E1|Reported Event|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
584591|NCT00954109|B1|Baseline|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)
Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
584592|NCT00954109|P1|Participant Flow|Exercise|"exercise - supervised exercise (treadmill walking or cycle ergometer use)
Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
584593|NCT00954109|O1|Outcome|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)
Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
584594|NCT00954109|O1|Outcome|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)
Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
584595|NCT00954109|E1|Reported Event|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)
Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
584909|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584597|NCT00954122|P1|Participant Flow|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
584598|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
584599|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
584600|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
584601|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
584602|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
584603|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
584604|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
584605|NCT00954122|E1|Reported Event|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
584606|NCT00954187|B3|Baseline|Total|Total of all reporting groups
584607|NCT00954187|B2|Baseline|Pregabalin|"Lyrica
pregabalin: 50 mg PO TID"
584608|NCT00954187|B1|Baseline|Gabapentin|"Neurontin
Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
584609|NCT00954187|P2|Participant Flow|Pregabalin|"Lyrica
pregabalin: 50 mg PO TID"
584610|NCT00954187|P1|Participant Flow|Gabapentin|"Neurontin
Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
584611|NCT00954187|O2|Outcome|Pregabalin|"Lyrica
pregabalin: 50 mg PO TID"
584612|NCT00954187|O1|Outcome|Gabapentin|"Neurontin
Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
584613|NCT00954187|E2|Reported Event|Pregabalin|"Lyrica
pregabalin: 50 mg PO TID"
584614|NCT00954187|E1|Reported Event|Gabapentin|"Neurontin
Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
584615|NCT00954356|B3|Baseline|Total|Total of all reporting groups
584616|NCT00954356|B2|Baseline|Placebo|5 x matching placebo capsules (administered as a single dose)
584617|NCT00954356|B1|Baseline|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
584618|NCT00954356|P2|Participant Flow|Placebo|5 x matching placebo capsules (administered as a single dose)
584619|NCT00954356|P1|Participant Flow|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
584620|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584621|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584622|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584623|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584624|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584625|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584626|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584627|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584628|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584629|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584630|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584631|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584760|NCT00954824|P1|Participant Flow|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).
Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
584632|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584633|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584634|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584635|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584636|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584637|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584638|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584639|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584640|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584641|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584642|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584643|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
584644|NCT00954356|E2|Reported Event|Placebo|5 x matching placebo capsules (administered as a single dose)
584645|NCT00954356|E1|Reported Event|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
584646|NCT00954421|B1|Baseline|All Subjects|All eligible subjects were enrolled and the intent was to treat for six months on dual lead deep brain stimulation in the VIM and VO regions.
584828|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584647|NCT00954421|P1|Participant Flow|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
584648|NCT00954421|O2|Outcome|TRS Scale Vo Only on vs. Vim Only on at 6 Months|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Vo only on -VM only on at 6 months.
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
584649|NCT00954421|O1|Outcome|TRS Scale Both Off vs Both on at 6 Months|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Both OFF- Both On) at 6 months.
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
584650|NCT00954421|O1|Outcome|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
584651|NCT00954421|E1|Reported Event|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
584652|NCT00954447|B3|Baseline|Total|Total of all reporting groups
584653|NCT00954447|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584710|NCT00954512|O6|Outcome|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
584654|NCT00954447|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584655|NCT00954447|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584656|NCT00954447|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584657|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584658|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584659|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584660|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584661|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584662|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584663|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584664|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584665|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584666|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584667|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584668|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584669|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584670|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584853|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584671|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584672|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584673|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584674|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584675|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584676|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584677|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584678|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584679|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584680|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584681|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584682|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584683|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584684|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584685|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584686|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584687|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584908|NCT00945100|O1|Outcome|Control|2 hours daily patching
584688|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584689|NCT00954447|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584690|NCT00954447|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
584691|NCT00954512|B7|Baseline|Total|Total of all reporting groups
584692|NCT00954512|B6|Baseline|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
584693|NCT00954512|B5|Baseline|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
584694|NCT00954512|B4|Baseline|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
584695|NCT00954512|B3|Baseline|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
584696|NCT00954512|B2|Baseline|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
584697|NCT00954512|B1|Baseline|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
584698|NCT00954512|P6|Participant Flow|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
584829|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
586216|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
584699|NCT00954512|P5|Participant Flow|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
584700|NCT00954512|P4|Participant Flow|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
584701|NCT00954512|P3|Participant Flow|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
584702|NCT00954512|P2|Participant Flow|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
584703|NCT00954512|P1|Participant Flow|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
584704|NCT00954512|O6|Outcome|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
584705|NCT00954512|O5|Outcome|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
584706|NCT00954512|O4|Outcome|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
584707|NCT00954512|O3|Outcome|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
584708|NCT00954512|O2|Outcome|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
584709|NCT00954512|O1|Outcome|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
584711|NCT00954512|O5|Outcome|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
584712|NCT00954512|O4|Outcome|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
584713|NCT00954512|O3|Outcome|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
584714|NCT00954512|O2|Outcome|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
584715|NCT00954512|O1|Outcome|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
584716|NCT00954512|E5|Reported Event|Regimen F: Gemcitabine (+/- Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 on Days 1, 8, 15, 22, 29, 36, and 43 (± erlotinib 100 mg per day) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 8 weeks.
584717|NCT00954512|E4|Reported Event|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
584718|NCT00954512|E3|Reported Event|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
584719|NCT00954512|E2|Reported Event|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
584720|NCT00954512|E1|Reported Event|Regimen A: FOLFIRI (+/- Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 followed by once-weekly doses of 250 mg/m^2) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 2 weeks.
584721|NCT00954538|B3|Baseline|Total|Total of all reporting groups
584722|NCT00954538|B2|Baseline|AD Participants (Part II/III)|This group includes AD participants (Part II/III). Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of brain
584723|NCT00954538|B1|Baseline|Healthy Participants (Part I) + HE Participants (Part II/III)|This group includes Healthy participants (Part I) and HE participants (Part II/III). Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
584782|NCT00944671|B5|Baseline|EZ Chew Without Water/Famotidine With Water/EZ Chew With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water
584724|NCT00954538|P6|Participant Flow|HE Participants (Part II + III)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II) / HE Participants who completed Part II could receive a second IV dose of ~150 MBq [18F]MK-3328 in Part III; this dose was followed by PET imaging of the brain
584725|NCT00954538|P5|Participant Flow|AD Participants (Part III Only)|AD participants received up to two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
584726|NCT00954538|P4|Participant Flow|HE Participants (Part III Only)|HE participants received up to two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
584727|NCT00954538|P3|Participant Flow|Alzheimer's Disease (AD) Participants (Part II Only)|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
584728|NCT00954538|P2|Participant Flow|Healthy Elderly (HE) Participants (Part II Only)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
584729|NCT00954538|P1|Participant Flow|Healthy Participants (Part I Only)|Healthy participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by Positron Emission Tomography (PET) imaging of the whole body (Part I)
584730|NCT00954538|O2|Outcome|HE Participants (Part III)|HE participants received two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
584731|NCT00954538|O1|Outcome|AD Participants (Part III)|AD participants received two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
584732|NCT00954538|O2|Outcome|HE Participants (Part II)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
584733|NCT00954538|O1|Outcome|AD Participants (Part II)|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
584734|NCT00954538|O1|Outcome|Healthy Participants (Part I)|Healthy participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the whole body (Part I)
584735|NCT00954538|O1|Outcome|Healthy Participants (Part I)|Healthy participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the whole body (Part I)
584736|NCT00954538|O1|Outcome|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
584737|NCT00954538|O1|Outcome|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
584738|NCT00954538|E1|Reported Event|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
584739|NCT00954707|B1|Baseline|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584740|NCT00954707|P1|Participant Flow|All Enrolled Subjects|Subjects signed the consent forms and met all protocol defined inclusion criteria and none of the exclusion criteria.
584910|NCT00945100|O1|Outcome|Control|2 hours daily patching
584741|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584742|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584743|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584744|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584745|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584746|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584747|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584748|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584749|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584750|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584751|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584752|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584753|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584754|NCT00954707|E1|Reported Event|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
584755|NCT00954733|B1|Baseline|All Participants|All participants in the study
584756|NCT00954733|P1|Participant Flow|All Participants|All participants undergoing surgery
584757|NCT00954733|O1|Outcome|All Participants|All participants undergoing surgery
584758|NCT00954733|E1|Reported Event|All Participants|All participants undergoing surgery
584759|NCT00954824|B1|Baseline|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).
Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
584761|NCT00954824|O1|Outcome|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).
Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
584762|NCT00954824|E1|Reported Event|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).
Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
584763|NCT00954915|B1|Baseline|Teplizumab|Anti CD-3 monoclonal antibody
584764|NCT00954915|P1|Participant Flow|Teplizumab|Anti CD-3 monoclonal antibody
584765|NCT00954915|O1|Outcome|Teplizumab|anti-CD3 monoclonal antibody
584766|NCT00954915|E1|Reported Event|Teplizumab|Anti CD-3 monoclonal antibody
584767|NCT00944645|B1|Baseline|All Participants|Includes all participants from Both treatment groups; MK0524A Phase III tablet and MK0524A New Site tablet
584768|NCT00944645|P2|Participant Flow|MK0524A New Site Tablet Then MK0524A Phase III Tablet|MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2)/ MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1)
584769|NCT00944645|P1|Participant Flow|MK0524A Phase III Tablet Then MK0524A New Site Tablet|MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1)/MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2)
584770|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
584771|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
584772|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
584773|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
584774|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
584775|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
584776|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
584777|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
584778|NCT00944645|E2|Reported Event|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
584779|NCT00944645|E1|Reported Event|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
584780|NCT00944671|B7|Baseline|Total|Total of all reporting groups
584781|NCT00944671|B6|Baseline|EZ Chew With Water/EZ Chew Without Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water
584783|NCT00944671|B4|Baseline|Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
584784|NCT00944671|B3|Baseline|EZ Chew With Water/Famotidine With Water/EZ Chew Without Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
584785|NCT00944671|B2|Baseline|EZ Chew Without Water/EZ Chew With Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water
584786|NCT00944671|B1|Baseline|Famotidine With Water/EZ Chew Without Water/EZ Chew With Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water
584787|NCT00944671|P6|Participant Flow|EZ Chew With Water/EZ Chew Without Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water
584788|NCT00944671|P5|Participant Flow|EZ Chew Without Water/Famotidine With Water/EZ Chew With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water
584789|NCT00944671|P4|Participant Flow|Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
584790|NCT00944671|P3|Participant Flow|EZ Chew With Water/Famotidine With Water/EZ Chew Without Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
584791|NCT00944671|P2|Participant Flow|EZ Chew Without Water/EZ Chew With Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water
584792|NCT00944671|P1|Participant Flow|Famotidine With Water/EZ Chew Without Water/EZ Chew With Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water
584793|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
584794|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet With Water|
584795|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
584796|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet With Water|
584797|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
584798|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet Without Water|
584799|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
584800|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet Without Water|
584801|NCT00944671|E3|Reported Event|Famotidine/Antacid Combination EZ Chew Tablet With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water
584802|NCT00944671|E2|Reported Event|Famotidine/Antacid Combination EZ Chew Tablet Without Water|Famotidine/antacid combination EZ Chew tablet without water
584803|NCT00944671|E1|Reported Event|Famotidine/Antacid Combination Tablet With Water|Famotidine/antacid combination tablet with 120 mL of water
584804|NCT00944697|B3|Baseline|Total|Total of all reporting groups
584805|NCT00944697|B2|Baseline|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
584806|NCT00944697|B1|Baseline|Placebo Tablets|A placebo tablet to match the active reference treatment
584807|NCT00944697|P2|Participant Flow|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
584808|NCT00944697|P1|Participant Flow|Placebo Tablets|A placebo tablet to match the active reference treatment
584809|NCT00944697|O2|Outcome|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
584810|NCT00944697|O1|Outcome|Placebo Tablets|A placebo tablet to match the active reference treatment
584811|NCT00944697|E2|Reported Event|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
584812|NCT00944697|E1|Reported Event|Placebo Tablets|A placebo tablet to match the active reference treatment
584813|NCT00944710|B3|Baseline|Total|Total of all reporting groups
584814|NCT00944710|B2|Baseline|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584815|NCT00944710|B1|Baseline|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584816|NCT00944710|P2|Participant Flow|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584817|NCT00944710|P1|Participant Flow|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584818|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584819|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584820|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584821|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584822|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584823|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584824|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584825|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584826|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584827|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584830|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584831|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584832|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584833|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584834|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584835|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584836|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584837|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584838|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584839|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584840|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584841|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584842|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584843|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584844|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584845|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584846|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584847|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584848|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584849|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584850|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584851|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584852|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584854|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584855|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584856|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584857|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584858|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584859|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584860|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584861|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584862|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584863|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584864|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584865|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584866|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584867|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584868|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584869|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584870|NCT00944710|E2|Reported Event|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye
Atropine: Weekend atropine 1%
Plano lens: plano lens over the sound eye"
584871|NCT00944710|E1|Reported Event|Control|"Weekend atropine 1%
Atropine: Weekend atropine 1%"
584872|NCT00944749|B1|Baseline|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
584873|NCT00944749|P1|Participant Flow|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
584874|NCT00944749|O1|Outcome|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
584875|NCT00944749|O1|Outcome|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
584876|NCT00944749|E1|Reported Event|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
584877|NCT00945035|B1|Baseline|All Participants in Study|
584878|NCT00945035|P2|Participant Flow|Etoricoxib URC Then Etoricoxib FMI|URC Formulation (30%), Unmilled Roller Compaction/ FMI Formulation (20%), Final Market Image
584879|NCT00945035|P1|Participant Flow|Etoricoxib FMI Then Etoricoxib URC|FMI Formulation (20%), Final Market Image/ URC Formulation (30%), Unmilled Roller Compaction
584880|NCT00945035|O2|Outcome|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
584881|NCT00945035|O1|Outcome|Etoricoxib FMI|FMI Formulation (20%), Final Market Image.
584882|NCT00945035|O2|Outcome|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
584883|NCT00945035|O1|Outcome|Etoricoxib FMI|FMI Formulation (20%), Final Market Image.
584884|NCT00945035|E2|Reported Event|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
584885|NCT00945035|E1|Reported Event|Etoricoxib FMI|FMI Formulation (20%), Final Market Image
584886|NCT00945100|B3|Baseline|Total|Total of all reporting groups
584887|NCT00945100|B2|Baseline|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584888|NCT00945100|B1|Baseline|Control|2 hours daily patching
584889|NCT00945100|P2|Participant Flow|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584890|NCT00945100|P1|Participant Flow|Control|2 hours daily patching
584891|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584892|NCT00945100|O1|Outcome|Control|2 hours daily patching
584893|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584894|NCT00945100|O1|Outcome|Control|2 hours daily patching
584895|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584896|NCT00945100|O1|Outcome|Control|2 hours daily patching
584897|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584898|NCT00945100|O1|Outcome|Control|2 hours daily patching
584899|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584900|NCT00945100|O1|Outcome|Control|2 hours daily patching
584901|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584902|NCT00945100|O1|Outcome|Control|2 hours daily patching
584903|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584904|NCT00945100|O1|Outcome|Control|2 hours daily patching
584905|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584906|NCT00945100|O1|Outcome|Control|2 hours daily patching
584907|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584911|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584912|NCT00945100|O1|Outcome|Control|2 hours daily patching
584913|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584914|NCT00945100|O1|Outcome|Control|2 hours daily patching
584915|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584916|NCT00945100|O1|Outcome|Control|2 hours daily patching
584917|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584918|NCT00945100|O1|Outcome|Control|2 hours daily patching
584919|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584920|NCT00945100|O1|Outcome|Control|2 hours daily patching
584921|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584922|NCT00945100|O1|Outcome|Control|2 hours daily patching
584923|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584924|NCT00945100|O1|Outcome|Control|2 hours daily patching
584925|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584926|NCT00945100|O1|Outcome|Control|2 hours daily patching
584927|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584928|NCT00945100|O1|Outcome|Control|2 hours daily patching
584929|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584930|NCT00945100|O1|Outcome|Control|2 hours daily patching
584931|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584932|NCT00945100|O1|Outcome|Control|2 hours daily patching
584933|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584934|NCT00945100|O1|Outcome|Control|2 hours daily patching
584935|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584936|NCT00945100|O1|Outcome|Control|2 hours daily patching
584937|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584938|NCT00945100|O1|Outcome|Control|2 hours daily patching
584939|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584940|NCT00945100|O1|Outcome|Control|2 hours daily patching
584941|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584942|NCT00945100|O1|Outcome|Control|2 hours daily patching
584943|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584944|NCT00945100|O1|Outcome|Control|2 hours daily patching
584945|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584946|NCT00945100|O1|Outcome|Control|2 hours daily patching
584947|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584948|NCT00945100|O1|Outcome|Control|2 hours daily patching
584951|NCT00945100|E2|Reported Event|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
584952|NCT00945100|E1|Reported Event|Control|2 hours daily patching
584953|NCT00945139|B1|Baseline|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
584954|NCT00945139|P1|Participant Flow|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
584955|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
584956|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
584957|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
584958|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
584959|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
584960|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
584961|NCT00945139|E1|Reported Event|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
585044|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
584962|NCT00945243|B1|Baseline|Treatment|"Treatment of cervical DDD with the Zero-P device
ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
584963|NCT00945243|P1|Participant Flow|Treatment|"Treatment of cervical DDD with the Zero-P device
ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
584964|NCT00945243|O1|Outcome|Treatment|"Treatment of cervical DDD with the Zero-P device
ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
584965|NCT00945243|O1|Outcome|Treatment|"Treatment of cervical DDD with the Zero-P device
ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
584966|NCT00945243|O1|Outcome|Treatment|"Treatment of cervical DDD with the Zero-P device
ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
584967|NCT00945243|E1|Reported Event|Treatment|"Treatment of cervical DDD with the Zero-P device
ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
584968|NCT00945256|B6|Baseline|Total|Total of all reporting groups
584969|NCT00945256|B5|Baseline|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
584970|NCT00945256|B4|Baseline|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
584971|NCT00945256|B3|Baseline|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
584972|NCT00945256|B2|Baseline|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
584973|NCT00945256|B1|Baseline|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
584974|NCT00945256|P5|Participant Flow|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
584975|NCT00945256|P4|Participant Flow|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
584976|NCT00945256|P3|Participant Flow|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
584977|NCT00945256|P2|Participant Flow|Elderly Aerobic Exercise|45 minutes of treadmill walking at 40% VO2 peak.
584978|NCT00945256|P1|Participant Flow|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak
584979|NCT00945256|O5|Outcome|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and a 7.5g amino acid drink taken orally.
584980|NCT00945256|O4|Outcome|Elderly Sodium Nitroprusside (SNP)|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
584981|NCT00945256|O3|Outcome|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
584982|NCT00945256|O2|Outcome|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
584983|NCT00945256|O1|Outcome|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
584984|NCT00945256|E5|Reported Event|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 grams of amino acids taken orally.
584985|NCT00945256|E4|Reported Event|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
584986|NCT00945256|E3|Reported Event|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
584987|NCT00945256|E2|Reported Event|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
584988|NCT00945256|E1|Reported Event|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
584989|NCT00945295|B3|Baseline|Total|Total of all reporting groups
584990|NCT00945295|B2|Baseline|Cohort #2|"Cohort 2 will receive BoNT-A alone
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
585045|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
585046|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
585047|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
584991|NCT00945295|B1|Baseline|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).
Rehabilitation Therapy : Rehabilitation therapy
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
584992|NCT00945295|P2|Participant Flow|Cohort #2|"Cohort 2 will receive BoNT-A alone
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
584993|NCT00945295|P1|Participant Flow|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).
Rehabilitation Therapy : Rehabilitation therapy
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
584994|NCT00945295|O2|Outcome|Cohort #2|"Cohort 2 will receive BoNT-A alone
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
584995|NCT00945295|O1|Outcome|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).
Rehabilitation Therapy : Rehabilitation therapy
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
584996|NCT00945295|O2|Outcome|Cohort #2|"Cohort 2 will receive BoNT-A alone
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
584997|NCT00945295|O1|Outcome|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).
Rehabilitation Therapy : Rehabilitation therapy
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
584998|NCT00945295|E2|Reported Event|Cohort #2|"Cohort 2 will receive BoNT-A alone
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
585022|NCT00945321|E3|Reported Event|150 mg Fosaprepitant Dimeglumine|150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state
585023|NCT00945321|E2|Reported Event|185 mg Aprepitant|185 mg aprepitant Final Market Composition capsule in the fasted state
585024|NCT00945321|E1|Reported Event|165 mg Aprepitant|165 mg aprepitant Final Market Composition capsule in the fasted state
584999|NCT00945295|E1|Reported Event|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).
Rehabilitation Therapy : Rehabilitation therapy
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
585000|NCT00945321|B1|Baseline|All Participants|All randomized patients.
585001|NCT00945321|P6|Participant Flow|C/B/A/E|"Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.
(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
585002|NCT00945321|P5|Participant Flow|B/A/C/E|"Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.
(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
585003|NCT00945321|P4|Participant Flow|A/C/B/E|"Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.
(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
585004|NCT00945321|P3|Participant Flow|C/A/B/D|"Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.
(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
585005|NCT00945321|P2|Participant Flow|B/C/A/D|"Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.
(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
585048|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
585777|NCT00947661|B2|Baseline|Reference0912|Reference0912 administered once daily for 12 weeks
585006|NCT00945321|P1|Participant Flow|A/B/C/D|"Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.
(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
585007|NCT00945321|O6|Outcome|185 mg Aprepitant (High-Fat)|"185 mg aprepitant Final Market Composition capsule in the fed state.
(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
585008|NCT00945321|O5|Outcome|185 mg Aprepitant (Light)|"185 mg aprepitant Final Market Composition capsule in the fed state.
(The subjects (9) in this treatment group received a standard light breakfast.)"
585009|NCT00945321|O4|Outcome|165 mg Aprepitant (High-Fat)|"165 mg aprepitant Final Market Composition capsule in the fed state.
(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
585010|NCT00945321|O3|Outcome|165 mg Aprepitant (Light)|"165 mg aprepitant Final Market Composition capsule in the fed state.
(The subjects (9) in this treatment group received a standard light breakfast.)"
585011|NCT00945321|O2|Outcome|185 mg Aprepitant (Fasted State)|185 mg aprepitant Final Market Composition capsule in the fasted state
585012|NCT00945321|O1|Outcome|165 mg Aprepitant (Fasted State)|165 mg aprepitant Final Market Composition capsule in the fasted state
585013|NCT00945321|O7|Outcome|185 mg Aprepitant (High-Fat)|"185 mg aprepitant Final Market Composition capsule in the fed state.
(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
585014|NCT00945321|O6|Outcome|185 mg Aprepitant (Light)|"185 mg aprepitant Final Market Composition capsule in the fed state.
(The subjects (9) in this treatment group received a standard light breakfast.)"
585015|NCT00945321|O5|Outcome|165 mg Aprepitant (High-Fat)|"165 mg aprepitant Final Market Composition capsule in the fed state.
(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
585016|NCT00945321|O4|Outcome|165 mg Aprepitant (Light)|"165 mg aprepitant Final Market Composition capsule in the fed state.
(The subjects (9) in this treatment group received a standard light breakfast.)"
585017|NCT00945321|O3|Outcome|150 mg Fosaprepitant Dimeglumine (Fasted State)|150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state
585018|NCT00945321|O2|Outcome|185 mg Aprepitant (Fasted State)|185 mg aprepitant Final Market Composition capsule in the fasted state
585019|NCT00945321|O1|Outcome|165 mg Aprepitant (Fasted State)|165 mg aprepitant Final Market Composition capsule in the fasted state
585020|NCT00945321|E5|Reported Event|185 mg Aprepitant (Fed State)|"185 mg aprepitant Final Market Composition capsule in the fed state.
(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
585021|NCT00945321|E4|Reported Event|165 mg Aprepitant (Fed State)|"165 mg aprepitant Final Market Composition capsule in the fed
state. (The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the
subjects (9) in this treatment group received a standard light breakfast)"
585025|NCT00945334|B3|Baseline|Total|Total of all reporting groups
585026|NCT00945334|B2|Baseline|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days
Neomycin: 500 mg po bid for 14 days
Rifaximin: 550 mg po tid"
585027|NCT00945334|B1|Baseline|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days
Neomycin: 500 mg po bid for 14 days
Placebo: placebo for 14 days tid"
585028|NCT00945334|P2|Participant Flow|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days
Neomycin: 500 mg po bid for 14 days
Rifaximin: 550 mg po tid"
585029|NCT00945334|P1|Participant Flow|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days
Neomycin: 500 mg po bid for 14 days
Placebo: placebo for 14 days tid"
585030|NCT00945334|O2|Outcome|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days
Neomycin: 500 mg po bid for 14 days
Rifaximin: 550 mg po tid"
585031|NCT00945334|O1|Outcome|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days
Neomycin: 500 mg po bid for 14 days
Placebo: placebo for 14 days tid"
585032|NCT00945334|O2|Outcome|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days
Neomycin: 500 mg po bid for 14 days
Rifaximin: 550 mg po tid"
585033|NCT00945334|O1|Outcome|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days
Neomycin: 500 mg po bid for 14 days
Placebo: placebo for 14 days tid"
585034|NCT00945334|E2|Reported Event|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days
Neomycin: 500 mg po bid for 14 days
Rifaximin: 550 mg po tid"
585035|NCT00945334|E1|Reported Event|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days
Neomycin: 500 mg po bid for 14 days
Placebo: placebo for 14 days tid"
585036|NCT00945477|B1|Baseline|Advanced Prostate Cancer, Treatment, Pazopanib|"Pazopanib
Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks"
585037|NCT00945477|P1|Participant Flow|Advanced Prostate Cancer, Treatment, Pazopanib|"Pazopanib
Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks"
585038|NCT00945477|O1|Outcome|Participants With Adverse Events 800mg Pazopanib|Adverse events for all participants, all grades
585039|NCT00945477|O1|Outcome|Pazopanib 800mg Daily by Mouth|Response rate at 12 weeks
585040|NCT00945477|E1|Reported Event|Pazopanib 800mg Daily by Mouth|Response rate at 12 weeks
585041|NCT00945555|B1|Baseline|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
585042|NCT00945555|P1|Participant Flow|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
585043|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
585049|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
585050|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
585051|NCT00945555|E1|Reported Event|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
585052|NCT00945750|B7|Baseline|Total|Total of all reporting groups
585053|NCT00945750|B6|Baseline|CT With Water / CT Without Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
585054|NCT00945750|B5|Baseline|CT Without Water / FCT With Water / CT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
585055|NCT00945750|B4|Baseline|FCT With Water / CT With Water / CT Without Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
585056|NCT00945750|B3|Baseline|CT With Water / FCT With Water / CT Without Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
585057|NCT00945750|B2|Baseline|CT Without Water / CT With Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
585058|NCT00945750|B1|Baseline|FCT With Water / CT Without Water / CT With Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
585059|NCT00945750|P6|Participant Flow|CT With Water / CT Without Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
585060|NCT00945750|P5|Participant Flow|CT Without Water / FCT With Water / CT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
585061|NCT00945750|P4|Participant Flow|FCT With Water / CT With Water / CT Without Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
585062|NCT00945750|P3|Participant Flow|CT With Water / FCT With Water / CT Without Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
585063|NCT00945750|P2|Participant Flow|CT Without Water / CT With Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
585064|NCT00945750|P1|Participant Flow|FCT With Water / CT Without Water / CT With Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
585065|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
585066|NCT00945750|O1|Outcome|Famotidine 20 mg CT With Water|Famotidine 20 mg CT with 120 mL of water
585067|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
585068|NCT00945750|O1|Outcome|Famotidine 20 mg CT With Water|Famotidine 20 mg CT with 120 mL of water
585069|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
585070|NCT00945750|O1|Outcome|Famotidine 20 mg CT Without Water|Famotidine 20 mg CT without water
585071|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
585072|NCT00945750|O1|Outcome|Famotidine 20 mg CT Without Water|Famotidine 20 mg CT without water
585073|NCT00945750|E3|Reported Event|Famotidine 20 mg CT With Water|Famotidine 20 mg chewable tablet with 120 mL of water
585074|NCT00945750|E2|Reported Event|Famotidine 20 mg CT Without Water|Famotidine 20 mg Chewable Tablet without water
585075|NCT00945750|E1|Reported Event|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT (film-coated tablet) with 120 mL of water
585076|NCT00945815|B1|Baseline|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
585077|NCT00945815|P1|Participant Flow|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
585262|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585078|NCT00945815|O1|Outcome|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
585079|NCT00945815|O1|Outcome|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
585080|NCT00945815|E1|Reported Event|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
585081|NCT00945854|B3|Baseline|Total|Total of all reporting groups
585082|NCT00945854|B2|Baseline|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index
Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585083|NCT00945854|B1|Baseline|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index
Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585084|NCT00945854|P2|Participant Flow|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index
Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585085|NCT00945854|P1|Participant Flow|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index
Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585086|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index
Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585087|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index
Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585088|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index
Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585089|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index
Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585090|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index
Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585091|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index
Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585092|NCT00945854|E2|Reported Event|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index
Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585093|NCT00945854|E1|Reported Event|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index
Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
585094|NCT00945893|B3|Baseline|Total|Total of all reporting groups
585095|NCT00945893|B2|Baseline|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585096|NCT00945893|B1|Baseline|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585157|NCT00945893|E4|Reported Event|Placebo Days 29-57|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585223|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
585097|NCT00945893|P2|Participant Flow|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585098|NCT00945893|P1|Participant Flow|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray administered approximately 28 days apart on Days 1 and 29.
585099|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585100|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585101|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585102|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585103|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585104|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585105|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585106|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585107|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585108|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585109|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585110|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585111|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585112|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585113|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585114|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585115|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585116|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585216|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
585217|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
585218|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
585117|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585118|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585119|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585120|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585121|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585122|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585123|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585124|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585125|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585126|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585284|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
592268|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years
585127|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585128|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585129|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585130|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585131|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585132|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585133|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585134|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585135|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585136|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585137|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585138|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585139|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585140|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585141|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585142|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585143|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585144|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585145|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585146|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585322|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
585323|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
585147|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585148|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585149|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585150|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585151|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585152|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585153|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
585154|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585155|NCT00945893|E6|Reported Event|Placebo Days 58-209|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585156|NCT00945893|E5|Reported Event|H1N1 Monovalent Days 58-209|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585224|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
585158|NCT00945893|E3|Reported Event|H1N1 Monovalent Vaccine Days 29-57|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585159|NCT00945893|E2|Reported Event|Placebo Days 1-15|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585160|NCT00945893|E1|Reported Event|H1N1 Monovalent Vaccine Days 1-15|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585161|NCT00945906|B1|Baseline|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
585162|NCT00945906|P1|Participant Flow|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
585163|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
585164|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
585165|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
585166|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
585167|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
585168|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
585169|NCT00945906|E1|Reported Event|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
585170|NCT00945945|B3|Baseline|Total|Total of all reporting groups
585237|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585324|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
585171|NCT00945945|B2|Baseline|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585172|NCT00945945|B1|Baseline|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585173|NCT00945945|P2|Participant Flow|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585174|NCT00945945|P1|Participant Flow|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585219|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
585220|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
585221|NCT00946088|O2|Outcome|Polyethylene & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
585222|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
585350|NCT00946348|O1|Outcome|Dronabinol|Dronabinol 15 mg
585175|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585176|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585177|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585178|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585179|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585238|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585325|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
585778|NCT00947661|B1|Baseline|SPARC0912|SPARC0912 administered once daily for 12 weeks
585180|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585181|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585182|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585183|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585184|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585185|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585186|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585187|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585188|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585239|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585189|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585190|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585191|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585192|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585193|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585194|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585195|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585196|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585197|NCT00945945|E2|Reported Event|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
585240|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585326|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
592269|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
585198|NCT00945945|E1|Reported Event|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
585199|NCT00945958|B1|Baseline|SPARC0913|Inhaled dose of SPARC0913. Each single dose was administered as 1, 2, 4 and 8 puffs from the inhaler.
585200|NCT00945958|P1|Participant Flow|SPARC0913|
585201|NCT00945958|O1|Outcome|SPARC0913|SPARC0913: One drop of SPARC0913 in affected eye once daily for 24 weeks
585202|NCT00945958|O1|Outcome|SPARC|The number and percentage of subjects reporting a TEAE were tabulated by system organ classification and preferred terms.
585203|NCT00945958|E1|Reported Event|SPARC0913|From the start of the study through Week 24 (Visit 7, End of Evaluations) adverse events were evaluated
585204|NCT00946088|B3|Baseline|Total|Total of all reporting groups
585205|NCT00946088|B2|Baseline|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil
585206|NCT00946088|B1|Baseline|Progesterone|Progesterone 400 mg per vagina qhs.
585207|NCT00946088|P2|Participant Flow|Polyethylene Glycol 400 Distearate & Hydrogenated Vegetable oi|Polyethylene glycol 400 distearate & hydrogenated vegetable oil
585208|NCT00946088|P1|Participant Flow|Progesterone|Progesterone 400 mg per vagina qhs.
585209|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
585210|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
585211|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
585212|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
585213|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
585214|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
585215|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
585225|NCT00946088|O2|Outcome|Polyethylene Glycol&Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
585226|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
585227|NCT00946088|E2|Reported Event|Placebo Comparator: Polyethylene Glycol&Hydrogenated Vegetab|Placebo Comparator:Polyethylene glycol&hydrogenated vegetable oil per vagina.
585228|NCT00946088|E1|Reported Event|Active Comparator: Progesterone|Progesterone 400mg per vagina qhs.
585229|NCT00946101|B3|Baseline|Total|Total of all reporting groups
585230|NCT00946101|B2|Baseline|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585231|NCT00946101|B1|Baseline|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585232|NCT00946101|P2|Participant Flow|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585233|NCT00946101|P1|Participant Flow|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585234|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585235|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585236|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585327|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
592392|NCT00959751|B1|Baseline|NXN-188|3 x 200 mg capsules
585241|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585242|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585243|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585244|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585245|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585246|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585247|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585248|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585249|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585250|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585251|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585252|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585253|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585254|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585255|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585256|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585257|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585258|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585259|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585260|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585261|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585263|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585264|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585265|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585266|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585267|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585268|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585269|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585270|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585271|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585272|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585273|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585274|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585275|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585276|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585277|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585278|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585279|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585280|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585281|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585282|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585283|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585285|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585286|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585287|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585288|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585289|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
585290|NCT00946101|E6|Reported Event|Placebo Days 58-209|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
585291|NCT00946101|E5|Reported Event|H1N1 Monovalent Vaccine Days 58-209|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
585292|NCT00946101|E4|Reported Event|Placebo Days 29-57|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
585293|NCT00946101|E3|Reported Event|H1N1 Monvalent Vaccine Days 29-57|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
585294|NCT00946101|E2|Reported Event|Placebo Days 1-28|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers
585295|NCT00946101|E1|Reported Event|H1N1 Monovalent Vaccine Days 1-28|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
585296|NCT00946114|B3|Baseline|Total|Total of all reporting groups
585297|NCT00946114|B2|Baseline|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
585298|NCT00946114|B1|Baseline|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
585299|NCT00946114|P2|Participant Flow|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
585300|NCT00946114|P1|Participant Flow|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
585301|NCT00946114|O2|Outcome|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
585351|NCT00946348|E2|Reported Event|Cannabis|Cannabis cigarette (3.6% THC)
585302|NCT00946114|O1|Outcome|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
585303|NCT00946114|E2|Reported Event|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
585304|NCT00946114|E1|Reported Event|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
585305|NCT00946296|B3|Baseline|Total|Total of all reporting groups
585306|NCT00946296|B2|Baseline|No Treatment|The experimental group receives no treatment.
585307|NCT00946296|B1|Baseline|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
585308|NCT00946296|P2|Participant Flow|No Treatment|The experimental group receives no treatment.
585309|NCT00946296|P1|Participant Flow|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
585310|NCT00946296|O2|Outcome|No Treatment|The experimental group receives no treatment.
585311|NCT00946296|O1|Outcome|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
585312|NCT00946296|E2|Reported Event|No Treatment|The experimental group receives no treatment.
585313|NCT00946296|E1|Reported Event|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
585314|NCT00946309|B3|Baseline|Total|Total of all reporting groups
585315|NCT00946309|B2|Baseline|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
585316|NCT00946309|B1|Baseline|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
585317|NCT00946309|P2|Participant Flow|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
585318|NCT00946309|P1|Participant Flow|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
585319|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
585320|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
585321|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
585328|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
585329|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
585330|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
585331|NCT00946309|E2|Reported Event|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
585332|NCT00946309|E1|Reported Event|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
585333|NCT00946322|B1|Baseline|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
585334|NCT00946322|P1|Participant Flow|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
585335|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
585336|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
585337|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
585338|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
585339|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
585340|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
585341|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
585342|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
585343|NCT00946322|E1|Reported Event|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
585344|NCT00946348|B3|Baseline|Total|Total of all reporting groups
585345|NCT00946348|B2|Baseline|Cannabis|Cannabis cigarette (3.6% THC)
585346|NCT00946348|B1|Baseline|Dronabinol|Dronabinol 15 mg
585347|NCT00946348|P2|Participant Flow|Cannabis|Cannabis cigarette (3.6% THC)
585348|NCT00946348|P1|Participant Flow|Dronabinol|Dronabinol 15 mg
585349|NCT00946348|O2|Outcome|Cannabis|Cannabis cigarette (3.6% THC)
585354|NCT00946478|B2|Baseline|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
585355|NCT00946478|B1|Baseline|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
585356|NCT00946478|P2|Participant Flow|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
585357|NCT00946478|P1|Participant Flow|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
585419|NCT00947115|P1|Participant Flow|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585358|NCT00946478|O2|Outcome|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
585359|NCT00946478|O1|Outcome|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
585360|NCT00946478|E2|Reported Event|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
585361|NCT00946478|E1|Reported Event|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
585362|NCT00946530|B5|Baseline|Total|Total of all reporting groups
585363|NCT00946530|B4|Baseline|Dim Light (Control) - Caregivers|Caregivers received dim light
585364|NCT00946530|B3|Baseline|Bright Light - Caregivers|Caregivers received bright light
585365|NCT00946530|B2|Baseline|Dim Light (Control) - AD Patients|AD patients received dim light
585366|NCT00946530|B1|Baseline|Bright Light-AD Patients|AD patients received bright light
585367|NCT00946530|P4|Participant Flow|Dim Light (Control) - Caregiver|Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
585368|NCT00946530|P3|Participant Flow|Bright Light - Caregiver|Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
585369|NCT00946530|P2|Participant Flow|Dim Light (Control) - AD Patients|AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
585370|NCT00946530|P1|Participant Flow|Bright Light - AD Patient|AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
585371|NCT00946530|O4|Outcome|Dim Light (Control) - Caregiver|Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
585372|NCT00946530|O3|Outcome|Bright Light - Caregiver|Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
585373|NCT00946530|O2|Outcome|Dim Light (Control) - AD Patients|AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
585401|NCT00946985|B1|Baseline|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
585374|NCT00946530|O1|Outcome|Bright Light - AD Patient|AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
585375|NCT00946530|O4|Outcome|Dim Light (Control) - Caregiver|Caregiver received regular (dim) Light
585376|NCT00946530|O3|Outcome|Bright Light - Caregiver|Caregiver received Bright Light
585377|NCT00946530|O2|Outcome|Dim Light (Control) - AD Patients|AD patient received regular (dim) light
585378|NCT00946530|O1|Outcome|Bright Light - AD Patient|AD patient received bright light
585379|NCT00946530|E4|Reported Event|Dim Light (Control) - Caregivers|Caregivers received dim light
585380|NCT00946530|E3|Reported Event|Bright Light - Caregivers|Caregivers received bright light
585381|NCT00946530|E2|Reported Event|Dim Light (Control) - AD Patients|AD patients received dim light
585382|NCT00946530|E1|Reported Event|Bright Light-AD Patients|AD patients received bright light
585383|NCT00946920|B3|Baseline|Total|Total of all reporting groups
585384|NCT00946920|B2|Baseline|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
585385|NCT00946920|B1|Baseline|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
585386|NCT00946920|P2|Participant Flow|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
585387|NCT00946920|P1|Participant Flow|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
585388|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
585389|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
585390|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
585391|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
585392|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
585393|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
585394|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
585395|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
585396|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
585397|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
585398|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
585399|NCT00946920|E2|Reported Event|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
585400|NCT00946920|E1|Reported Event|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
586217|NCT00957034|O1|Outcome|Placebo|placebo patch
585402|NCT00946985|P1|Participant Flow|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
585403|NCT00946985|O1|Outcome|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
585404|NCT00946985|E1|Reported Event|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
585405|NCT00947011|B1|Baseline|All Particpants|"Januvia: 1 tablet 100 mg once a day
OR
Placebo: 1 tablet 100 mg once a day"
585406|NCT00947011|P1|Participant Flow|All Participants|"Januvia: 1 tablet 100 mg once a day
OR
Placebo comparator"
585407|NCT00947011|O2|Outcome|Placebo|Placebo: 1 tablet 100 mg once a day
585408|NCT00947011|O1|Outcome|Januvia|Januvia: 1 tablet 100 mg once a day
585409|NCT00947011|O2|Outcome|Placebo|Placebo: 1 tablet 100 mg once a day
585410|NCT00947011|O1|Outcome|Januvia|Januvia: 1 tablet 100 mg once a day
585411|NCT00947011|E2|Reported Event|Placebo|Placebo: 1 tablet 100 mg once a day
585412|NCT00947011|E1|Reported Event|Januvia|Januvia: 1 tablet 100 mg once a day
585413|NCT00947115|B4|Baseline|Total|Total of all reporting groups
585414|NCT00947115|B3|Baseline|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585415|NCT00947115|B2|Baseline|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585416|NCT00947115|B1|Baseline|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585417|NCT00947115|P3|Participant Flow|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585418|NCT00947115|P2|Participant Flow|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585492|NCT00947219|B4|Baseline|Total|Total of all reporting groups
585493|NCT00947219|B3|Baseline|Control Device|Control device emitting LED light
585420|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585421|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585422|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585423|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585424|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585425|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585426|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585427|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585428|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585429|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585430|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585431|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585432|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585433|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585434|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585563|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay
Long delay : Programming of a prolonged delay"
585435|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585436|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585437|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585438|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585439|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585440|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585441|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585442|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585443|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585444|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585494|NCT00947219|B2|Baseline|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
585495|NCT00947219|B1|Baseline|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
585445|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585446|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585447|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585448|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585449|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585450|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585451|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585452|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585453|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585454|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585455|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585456|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585457|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585458|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585459|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585460|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585461|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585462|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585463|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585464|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585465|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585466|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585467|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585468|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585469|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585496|NCT00947219|P3|Participant Flow|Control Device|Control device emitting LED light
585497|NCT00947219|P2|Participant Flow|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
585470|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585471|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585472|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585473|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585474|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585475|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585476|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585477|NCT00947115|E3|Reported Event|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585478|NCT00947115|E2|Reported Event|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585479|NCT00947115|E1|Reported Event|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
585480|NCT00947154|B1|Baseline|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
585481|NCT00947154|P1|Participant Flow|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
585564|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff
High rate cutoff : Programming of a high rate cutoff"
585565|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming
Standard ICD programming : Standard ICD programming"
585482|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
585483|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
585484|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
585485|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
585486|NCT00947154|E1|Reported Event|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
585487|NCT00947167|B1|Baseline|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv
erlotinib: 150 mg, PO"
585488|NCT00947167|P1|Participant Flow|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv
erlotinib: 150 mg, PO"
585489|NCT00947167|O1|Outcome|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv
erlotinib: 150 mg, PO"
585490|NCT00947167|O1|Outcome|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv
erlotinib: 150 mg, PO"
585491|NCT00947167|E1|Reported Event|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv
erlotinib: 150 mg, PO"
585498|NCT00947219|P1|Participant Flow|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
585499|NCT00947219|O3|Outcome|Control Device|Control device emitting white light
585500|NCT00947219|O2|Outcome|HairMax LaserComb 2009 9 Beam|the active LLLT Device 2009 9 laser modules
585501|NCT00947219|O1|Outcome|HairMax LaserComb 2009, 12 Beam|The active LLLT Device 2009 with 12 laser modules
585502|NCT00947219|E3|Reported Event|Control Device|Control device emitting LED light
585503|NCT00947219|E2|Reported Event|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
585504|NCT00947219|E1|Reported Event|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
585505|NCT00947271|B5|Baseline|Total|Total of all reporting groups
585506|NCT00947271|B4|Baseline|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585507|NCT00947271|B3|Baseline|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585508|NCT00947271|B2|Baseline|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585509|NCT00947271|B1|Baseline|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585510|NCT00947271|P4|Participant Flow|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585511|NCT00947271|P3|Participant Flow|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585512|NCT00947271|P2|Participant Flow|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585513|NCT00947271|P1|Participant Flow|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585566|NCT00947310|E3|Reported Event|C - Long ICD Duration Delay|"Long ICD duration delay
Long delay : Programming of a prolonged delay"
587419|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
585514|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585515|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585516|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585517|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585518|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585519|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585520|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585521|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585522|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585523|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585524|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585525|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585526|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585527|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585528|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585529|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585530|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585531|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585532|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585533|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585567|NCT00947310|E2|Reported Event|B - High Rate Cutoff|"High rate cutoff
High rate cutoff : Programming of a high rate cutoff"
586218|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
585534|NCT00947271|E4|Reported Event|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585535|NCT00947271|E3|Reported Event|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.
DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
585536|NCT00947271|E2|Reported Event|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585537|NCT00947271|E1|Reported Event|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.
DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
585538|NCT00947284|B1|Baseline|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
585539|NCT00947284|P2|Participant Flow|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
585540|NCT00947284|P1|Participant Flow|Women-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
585541|NCT00947284|O1|Outcome|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
585542|NCT00947284|E1|Reported Event|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
585543|NCT00947297|B1|Baseline|HPN-100|Patients who were treated with HPN-100
585544|NCT00947297|P1|Participant Flow|HPN-100|Patients who were treated with HPN-100
585545|NCT00947297|O1|Outcome|HPN-100|"Patients who were treated with HPN-100
HPN-100: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do."
585546|NCT00947297|O1|Outcome|HPN-100|"Patients who were treated with HPN-100
HPN-100: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do."
585547|NCT00947297|O1|Outcome|HPN-100|Patients who were treated with HPN-100
585548|NCT00947297|O1|Outcome|HPN-100|Patients who were treated with HPN-100
585549|NCT00947297|E1|Reported Event|HPN-100|Patients who were treated with HPN-100
585550|NCT00947310|B4|Baseline|Total|Total of all reporting groups
585551|NCT00947310|B3|Baseline|C - Long ICD Duration Delay|"Long ICD duration delay
Long delay : Programming of a prolonged delay"
585552|NCT00947310|B2|Baseline|B - High Rate Cutoff|"High rate cutoff
High rate cutoff : Programming of a high rate cutoff"
585553|NCT00947310|B1|Baseline|A - Standard ICD Programming|"Standard ICD Programming
Standard ICD programming : Standard ICD programming"
585554|NCT00947310|P3|Participant Flow|C - Long ICD Duration Delay|"Long ICD duration delay
Long delay : Programming of a prolonged delay"
585555|NCT00947310|P2|Participant Flow|B - High Rate Cutoff|"High rate cutoff
High rate cutoff : Programming of a high rate cutoff"
585556|NCT00947310|P1|Participant Flow|A - Standard ICD Programming|"Standard ICD Programming
Standard ICD programming : Standard ICD programming"
585557|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay
Long delay : Programming of a prolonged delay"
585558|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff
High rate cutoff : Programming of a high rate cutoff"
585559|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming
Standard ICD programming : Standard ICD programming"
585560|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay
Long delay : Programming of a prolonged delay"
585561|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff
High rate cutoff : Programming of a high rate cutoff"
585562|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming
Standard ICD programming : Standard ICD programming"
585745|NCT00947531|P2|Participant Flow|0.9% Saline Solution|
585568|NCT00947310|E1|Reported Event|A - Standard ICD Programming|"Standard ICD Programming
Standard ICD programming : Standard ICD programming"
585569|NCT00947349|B5|Baseline|Total|Total of all reporting groups
585570|NCT00947349|B4|Baseline|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585571|NCT00947349|B3|Baseline|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.). with PegIFN/RBV in TN patients
585572|NCT00947349|B2|Baseline|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585573|NCT00947349|B1|Baseline|Placebo in TN Patients|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
585574|NCT00947349|P4|Participant Flow|BI 201335 NA High for Treatment Experienced (TE)|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in treatment experienced (TE) patients.
585575|NCT00947349|P3|Participant Flow|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585576|NCT00947349|P2|Participant Flow|BI 201335 NA Low for Treatment Naive (TN)|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d. (once daily)) with PegIFN/RBV in treatment naive (TN) patients
585577|NCT00947349|P1|Participant Flow|Placebo in Treatment Naive (TN) Patients|Matching placebo to BI 201335 (Faldaprevir) NA (sodium) with PegIFN/RBV in TN patients
585578|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585579|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585580|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585581|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585582|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585583|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585584|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
585585|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585671|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
585586|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585587|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585588|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585589|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585590|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585591|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
585592|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585593|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585594|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585595|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585596|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585597|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585598|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585599|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585600|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585601|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
585602|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585603|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585604|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585605|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585606|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585607|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585608|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
585609|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585610|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585746|NCT00947531|P1|Participant Flow|Cerebrolysin|
585611|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585612|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585613|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585614|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585615|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
585616|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585617|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585618|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585619|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
585620|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585621|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585622|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585623|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
585624|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585625|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585626|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
585627|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
585628|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585774|NCT00947544|O1|Outcome|HPN-100|HPN-100: Patients treated with HPN-100
585629|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585630|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585631|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa-2a in TN patients
585632|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585633|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585634|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585635|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585636|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585637|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585638|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585639|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585640|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585641|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585642|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585643|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585644|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585645|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585646|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
585647|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
585648|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585649|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585650|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
585651|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
585652|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585653|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585654|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
585655|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
585656|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585657|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585658|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585659|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
585660|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585661|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585662|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585663|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
585664|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585665|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585666|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585667|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
585668|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585669|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585670|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585672|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585673|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585674|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585675|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
585676|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585677|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585678|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585679|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
585680|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585681|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585682|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585683|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
585684|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585685|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585686|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585687|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
585688|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
585689|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
585690|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
585691|NCT00947349|O1|Outcome|Placebo in TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
585692|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585693|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585694|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
585695|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
585747|NCT00947531|O2|Outcome|0.9% Saline Solution|
585748|NCT00947531|O1|Outcome|Cerebrolysin|
585696|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585697|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
585698|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
585699|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
585700|NCT00947349|E8|Reported Event|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
585701|NCT00947349|E7|Reported Event|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
585702|NCT00947349|E6|Reported Event|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
585703|NCT00947349|E5|Reported Event|SOC TN Placebo|Standard of care for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
585704|NCT00947349|E4|Reported Event|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
585705|NCT00947349|E3|Reported Event|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
585706|NCT00947349|E2|Reported Event|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
585707|NCT00947349|E1|Reported Event|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
585708|NCT00947427|B3|Baseline|Total|Total of all reporting groups
585709|NCT00947427|B2|Baseline|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
585710|NCT00947427|B1|Baseline|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
585711|NCT00947427|P2|Participant Flow|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
585712|NCT00947427|P1|Participant Flow|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
585775|NCT00947544|E1|Reported Event|HPN-100|HPN-100: Patient treated with HPN-100
585713|NCT00947427|O2|Outcome|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
585714|NCT00947427|O1|Outcome|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
585715|NCT00947427|E2|Reported Event|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
585716|NCT00947427|E1|Reported Event|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
585717|NCT00947505|B3|Baseline|Total|Total of all reporting groups
585718|NCT00947505|B2|Baseline|Control Device|
585719|NCT00947505|B1|Baseline|LLT Device 2009 7 Beam|
585720|NCT00947505|P2|Participant Flow|Control Device|
585721|NCT00947505|P1|Participant Flow|LLT Device 2009 7 Beam|
585722|NCT00947505|O2|Outcome|Control Device|This is the control device emitting white light
585723|NCT00947505|O1|Outcome|LLT Device 2009 7 Beam|This is the active LLLT device
585724|NCT00947505|E2|Reported Event|Control Device|
585725|NCT00947505|E1|Reported Event|LLT Device 2009 7 Beam|
585726|NCT00947518|B4|Baseline|Total|Total of all reporting groups
585727|NCT00947518|B3|Baseline|No Skin Cleansing|No skin application
585728|NCT00947518|B2|Baseline|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
585729|NCT00947518|B1|Baseline|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
585730|NCT00947518|P3|Participant Flow|No Skin Cleansing|No skin application
585731|NCT00947518|P2|Participant Flow|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
585732|NCT00947518|P1|Participant Flow|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
585733|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
585734|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
585735|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
585736|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
585737|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
585738|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
585739|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
585740|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
585741|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
585742|NCT00947531|B3|Baseline|Total|Total of all reporting groups
585743|NCT00947531|B2|Baseline|0.9% Saline Solution|
585744|NCT00947531|B1|Baseline|Cerebrolysin|
585751|NCT00947544|B1|Baseline|Participants in SO and SE|Patients who completed switch over study and enrolled safety extension study
585752|NCT00947544|P2|Participant Flow|Safety Extension Only|Participants entered the safety extension part of the study only, and received open-label HPN-100 for up to 12 months.
585753|NCT00947544|P1|Participant Flow|Swich Over and Safety Extension|NaPBA was dosed three times daily (TID) with during the first week and the same PBA mole-equivalent dose of HPN-100 during the second week. If there were safety concerns regarding a single-step transition from NaPBA to HPN-100, at the investigator's discretion, the transition could occur in 2 steps such that in the second week, subjects might receive 50% of the PBA equivalent dose as NaPBA and 50% as HPN-100 before receiving 100% of Serial blood samples were collected for PK and blood ammonia assessments after each drug reached steady state, which was achieved approximately 4 days after initiation of 100% NaPBA or HPN100 treatment. After the switch over, participants entered the safety extension part of the study and continued receiving open-label HPN-100 for up to 12 months.
585754|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100 who completed SF-15 at baseline and Month 12
585755|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
585756|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
585757|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
585758|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
585759|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
585760|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
585761|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
585762|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
585763|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
585764|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
585765|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
585766|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
585767|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
585768|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
585769|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
585770|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
585771|NCT00947544|O2|Outcome|Safety Extension (HPN-100)|
585772|NCT00947544|O1|Outcome|Pre-Enrollment (NaPBA)|
585773|NCT00947544|O2|Outcome|NaPBA|NaPBA: Patients treated with NaPBA
585779|NCT00947661|P2|Participant Flow|Reference0912|Reference0912 administered once daily for 12 weeks
585780|NCT00947661|P1|Participant Flow|SPARC0912|SPARC0912 administered once daily for 12 weeks
585781|NCT00947661|O2|Outcome|Reference0912|
585782|NCT00947661|O1|Outcome|SPARC0912|The change from baseline in intraocular pressure was calculated. A positive change from baseline suggested a reduction from baseline in intraocular pressure. Change from baseline was analyzed using an analysis of covariance methodology, a two-sided 95% CI for the difference between treatment groups in estimated mean change from baseline (i.e., LS means derived from the ANCOVA model) was computed for each time point at each visit (a total of 12 time points at 4 visits i.e. 3 time points at each visit).
585783|NCT00947661|E2|Reported Event|Reference0912|Reference formulation administered once daily for 12 weeks
585784|NCT00947661|E1|Reported Event|SPARC0912|SPARC's formulation administered once daily for 12 weeks
585785|NCT00947752|B3|Baseline|Total|Total of all reporting groups
585786|NCT00947752|B2|Baseline|F2 Glatiramer Acetate 20mg/0.5ml|
585787|NCT00947752|B1|Baseline|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
585788|NCT00947752|P2|Participant Flow|F2 Glatiramer Acetate 20mg/0.5ml|
585789|NCT00947752|P1|Participant Flow|F1 Glatiramer Acetate 20mg/1.0ml|
585790|NCT00947752|O2|Outcome|F2 Glatiramer Acetate 20mg/0.5ml|
585791|NCT00947752|O1|Outcome|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
585792|NCT00947752|O2|Outcome|F2 Glatiramer Acetate 20mg/0.5ml|
585793|NCT00947752|O1|Outcome|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
585794|NCT00947752|E2|Reported Event|F2 Glatiramer Acetate 20mg/0.5ml|
585795|NCT00947752|E1|Reported Event|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
585796|NCT00947765|B3|Baseline|Total|Total of all reporting groups
585797|NCT00947765|B2|Baseline|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
585798|NCT00947765|B1|Baseline|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
585799|NCT00947765|P2|Participant Flow|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
585800|NCT00947765|P1|Participant Flow|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
585801|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
585802|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
585803|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
585804|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
585805|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
585806|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
585807|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
586000|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group were assessed before they received rTMS treatment.
585808|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
585809|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
585810|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
585811|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
585812|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
585813|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
585814|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
585815|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
585816|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
585817|NCT00947765|E2|Reported Event|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
585818|NCT00947765|E1|Reported Event|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
585819|NCT00947791|B3|Baseline|Total|Total of all reporting groups
585820|NCT00947791|B2|Baseline|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
585821|NCT00947791|B1|Baseline|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
585822|NCT00947791|P2|Participant Flow|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
585866|NCT00947856|E2|Reported Event|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion
585823|NCT00947791|P1|Participant Flow|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
585824|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
585825|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
585826|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
585827|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
585828|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
585829|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
585830|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
585831|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
585832|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
585833|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
585834|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
585835|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
585836|NCT00947791|E2|Reported Event|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
585837|NCT00947791|E1|Reported Event|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
585838|NCT00947856|B3|Baseline|Total|Total of all reporting groups
585839|NCT00947856|B2|Baseline|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
585840|NCT00947856|B1|Baseline|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
585841|NCT00947856|P2|Participant Flow|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
585842|NCT00947856|P1|Participant Flow|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
585843|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
585844|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
586219|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
585845|NCT00947856|O5|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
585846|NCT00947856|O4|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
585847|NCT00947856|O3|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
585848|NCT00947856|O2|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
585849|NCT00947856|O1|Outcome|BV Extension Total|All patients enrolled and treated on the extension arm
585850|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
585851|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
585852|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
585853|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
585854|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
585855|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
585856|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
585857|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
585858|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
585859|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
585860|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
585861|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
585862|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
585863|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
585864|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
585865|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
585867|NCT00947856|E1|Reported Event|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion
585868|NCT00947882|B5|Baseline|Total|Total of all reporting groups
585869|NCT00947882|B4|Baseline|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585870|NCT00947882|B3|Baseline|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585871|NCT00947882|B2|Baseline|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585872|NCT00947882|B1|Baseline|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585873|NCT00947882|P4|Participant Flow|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585874|NCT00947882|P3|Participant Flow|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585875|NCT00947882|P2|Participant Flow|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585876|NCT00947882|P1|Participant Flow|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
585877|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585878|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585879|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585880|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
585881|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585882|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585883|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585884|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
585885|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585886|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585887|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585888|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
585889|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585890|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
586220|NCT00957034|O1|Outcome|Placebo|placebo patch
585891|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585892|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
585893|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585894|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585895|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
585896|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
585897|NCT00947882|E4|Reported Event|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585898|NCT00947882|E3|Reported Event|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585899|NCT00947882|E2|Reported Event|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585900|NCT00947882|E1|Reported Event|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
585901|NCT00948064|B4|Baseline|Total|Total of all reporting groups
585902|NCT00948064|B3|Baseline|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
585903|NCT00948064|B2|Baseline|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
585904|NCT00948064|B1|Baseline|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
585905|NCT00948064|P3|Participant Flow|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
585906|NCT00948064|P2|Participant Flow|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
586019|NCT00955110|O3|Outcome|Oxymorphone ER 30 mg|Subjects received a single oral dose (1 capsule) of Oxymorphone ER 30 mg.
585907|NCT00948064|P1|Participant Flow|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
585908|NCT00948064|O2|Outcome|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
585909|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
585910|NCT00948064|O3|Outcome|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
585911|NCT00948064|O2|Outcome|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
585912|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
585913|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
585914|NCT00948064|E3|Reported Event|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
585915|NCT00948064|E2|Reported Event|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
585916|NCT00948064|E1|Reported Event|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
585917|NCT00948090|B3|Baseline|Total|Total of all reporting groups
585918|NCT00948090|B2|Baseline|Hodgkin's/Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585919|NCT00948090|B1|Baseline|Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585920|NCT00948090|P4|Participant Flow|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
589343|NCT00966238|B3|Baseline|2.0 µg i.m.|
585921|NCT00948090|P3|Participant Flow|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585922|NCT00948090|P2|Participant Flow|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585923|NCT00948090|P1|Participant Flow|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585924|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585925|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585926|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585927|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585928|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
586020|NCT00955110|O2|Outcome|Oxymorphone ER 15 mg|Subjects received a single oral dose (1 capsule) of Oxymorphone ER 15 mg.
585929|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585930|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585931|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585932|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585933|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585934|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585935|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585936|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585937|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585938|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
586221|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
585939|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
585940|NCT00948090|E1|Reported Event|Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years)|The safety data set consisted of all screened participants who had received at least 1 dose of IV busulfan (including PK test dose).
585941|NCT00948155|B3|Baseline|Total|Total of all reporting groups
585942|NCT00948155|B2|Baseline|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
585943|NCT00948155|B1|Baseline|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
585944|NCT00948155|P2|Participant Flow|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
585945|NCT00948155|P1|Participant Flow|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
585946|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
585947|NCT00948155|O1|Outcome|Placebo|21 days using placebo
585948|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
585949|NCT00948155|O1|Outcome|Placebo|21 days using placebo
585950|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
585951|NCT00948155|O1|Outcome|Placebo|21 days using placebo
585952|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
585953|NCT00948155|O1|Outcome|Placebo|21 days using placebo
585954|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
585955|NCT00948155|O1|Outcome|Placebo|21 days using placebo
585956|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
585957|NCT00948155|O1|Outcome|Placebo|21 days using placebo
586021|NCT00955110|O1|Outcome|Placebo|Subjects received a single oral dose (1 capsule) of placebo.
585958|NCT00948155|O2|Outcome|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
585959|NCT00948155|O1|Outcome|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
585960|NCT00948155|O2|Outcome|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
585961|NCT00948155|O1|Outcome|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
585962|NCT00948155|E2|Reported Event|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
585963|NCT00948155|E1|Reported Event|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.
Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
585964|NCT00948246|B1|Baseline|Easyband|
585965|NCT00948246|P1|Participant Flow|Easyband|
585966|NCT00948246|O1|Outcome|Easyband|
585967|NCT00948246|O1|Outcome|Easyband|
585968|NCT00948246|O1|Outcome|Easyband|
585969|NCT00948246|O1|Outcome|Easyband|
585970|NCT00948246|E1|Reported Event|Easyband|
585971|NCT00954941|B3|Baseline|Total|Total of all reporting groups
585972|NCT00954941|B2|Baseline|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
585973|NCT00954941|B1|Baseline|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
585998|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
585999|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed before they received sham treatment.
589344|NCT00966238|B2|Baseline|1.0 µg i.m.|
585974|NCT00954941|P2|Participant Flow|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
585975|NCT00954941|P1|Participant Flow|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
585976|NCT00954941|O2|Outcome|Group 2: Ondansetron + Aprepitant|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose."
585977|NCT00954941|O1|Outcome|Group 1: Ondansetron|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy."
585978|NCT00954941|O2|Outcome|Group 2: Ondansetron + Aprepitant|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose."
585979|NCT00954941|O1|Outcome|Group 1: Ondansetron|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy."
585980|NCT00954941|E2|Reported Event|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
586140|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
585981|NCT00954941|E1|Reported Event|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
585982|NCT00954993|B1|Baseline|Vaniprevir 600 mg - 300 mg Arm|For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
585983|NCT00954993|P1|Participant Flow|Vaniprevir 600 mg - 300 mg Arm|For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
585984|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
585985|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
585986|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
585987|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
585988|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
585989|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
585990|NCT00954993|E2|Reported Event|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
585991|NCT00954993|E1|Reported Event|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
585992|NCT00955032|B3|Baseline|Total|Total of all reporting groups
585993|NCT00955032|B2|Baseline|Sham Treatment|Participants in this group did not receive rTMS treatment.
585994|NCT00955032|B1|Baseline|rTMS Treatment|Participants in this group received rTMS treatment.
585995|NCT00955032|P2|Participant Flow|Sham Treatment|Participants in this group did not receive rTMS treatment.
585996|NCT00955032|P1|Participant Flow|rTMS Treatment|Participants in this group received rTMS treatment.
585997|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
589345|NCT00966238|B1|Baseline|0.5 µg i.m.|
586001|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
586002|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
586003|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed before they received Sham tx.
586004|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group were assessed before they received rTMS treatment.
586005|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
586006|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
586007|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed prior to receiving Sham treatment.
586008|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group received were assessed prior to receiving rTMS treatment.
586009|NCT00955032|O4|Outcome|Sham Post Tx (Immediate)|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
586010|NCT00955032|O3|Outcome|rTMS Post TX (Immediate)|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
586011|NCT00955032|O2|Outcome|Sham Pre TX|Participants in this group were assessed before sham treatment.
586012|NCT00955032|O1|Outcome|rTMS Pre TX|Participants in this group were assessed prior to rTMS treatment.
586013|NCT00955032|E2|Reported Event|Sham Treatment|Participants in this group did not receive rTMS treatment.
586014|NCT00955032|E1|Reported Event|rTMS Treatment|Participants in this group received rTMS treatment.
586015|NCT00955110|B1|Baseline|All Subjects Randomized to Treatment Phase|Forty one (41) qualified subjects were randomized into the treatment phase (Randomized population). Subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg.
586016|NCT00955110|P1|Participant Flow|All Subjects|"Subjects enrolled were healthy non-dependent recreational opioid users. During the Treatment Phase, subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg.
All participants did not necessarily receive the 5 drug interventions in the order reported as Milestones."
586017|NCT00955110|O5|Outcome|Oxycodone CR 60 mg|Subjects received a single oral dose (1 capsule) of Oxycodone CR 60 mg.
586018|NCT00955110|O4|Outcome|Oxycodone CR 30 mg|Subjects received a single oral dose (1 capsule) of Oxycodone CR 30 mg.
586022|NCT00955110|E5|Reported Event|Treatment Phase Oxycodone CR 60 mg|Single oral dose (1 capsule) of Oxycodone HCl CR 60 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
586023|NCT00955110|E4|Reported Event|Treatment Phase Oxycodone CR 30mg|Single oral dose (1 capsule) of Oxycodone HCl CR 30 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
586024|NCT00955110|E3|Reported Event|Treatment Phase Oxymorphone ER 30mg|Single oral dose (1 capsule) of Oxymorphone HCl ER 30 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
586025|NCT00955110|E2|Reported Event|Treatment Phase Oxymorphone ER 15 mg|Single oral dose (1 capsule) of Oxymorphone HCl ER 15 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
586026|NCT00955110|E1|Reported Event|Treatment Phase Placebo|Identical placebo capsules using size AA Swedish orange capsules and microcrystalline cellulose.
586027|NCT00956085|B1|Baseline|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
586028|NCT00956085|P1|Participant Flow|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
586029|NCT00956085|O1|Outcome|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response, either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
586030|NCT00956085|E1|Reported Event|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
586031|NCT00956254|B1|Baseline|Fentanyl Sublingual Spray 100 µg|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
586032|NCT00956254|P1|Participant Flow|Fentanyl Sublingual Spray 100 µg|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
586033|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
586034|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
586035|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
586036|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
586222|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
586037|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
586038|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
586039|NCT00956254|E2|Reported Event|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
586040|NCT00956254|E1|Reported Event|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
586041|NCT00956293|B3|Baseline|Total|Total of all reporting groups
586042|NCT00956293|B2|Baseline|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586043|NCT00956293|B1|Baseline|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586044|NCT00956293|P3|Participant Flow|Pre-randomized Group|Participants, who met BL1 eligibility, were enrolled into the study.
586045|NCT00956293|P2|Participant Flow|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586046|NCT00956293|P1|Participant Flow|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586047|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586048|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586049|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586253|NCT00957047|O1|Outcome|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
586050|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586051|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586052|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586053|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586054|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586055|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586056|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586057|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586058|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586059|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586060|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586223|NCT00957034|O1|Outcome|Placebo|placebo patch
586061|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586062|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586063|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586064|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586065|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586066|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586067|NCT00956293|E2|Reported Event|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
586068|NCT00956293|E1|Reported Event|Control Goup|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
586069|NCT00956540|B5|Baseline|Total|Total of all reporting groups
586070|NCT00956540|B4|Baseline|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
586071|NCT00956540|B3|Baseline|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
586254|NCT00957047|E5|Reported Event|ESL PART II|All patients in Part II received ESL
586072|NCT00956540|B2|Baseline|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
586073|NCT00956540|B1|Baseline|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
586074|NCT00956540|P4|Participant Flow|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
586075|NCT00956540|P3|Participant Flow|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
586076|NCT00956540|P2|Participant Flow|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
586077|NCT00956540|P1|Participant Flow|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
586078|NCT00956540|O4|Outcome|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
586079|NCT00956540|O3|Outcome|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
586080|NCT00956540|O2|Outcome|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
586081|NCT00956540|O1|Outcome|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
586082|NCT00956540|E4|Reported Event|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
586083|NCT00956540|E3|Reported Event|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
586168|NCT00956943|P1|Participant Flow|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch
Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks
placebo : placebo patch"
586084|NCT00956540|E2|Reported Event|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
586085|NCT00956540|E1|Reported Event|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
586086|NCT00956592|B3|Baseline|Total|Total of all reporting groups
586087|NCT00956592|B2|Baseline|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
586088|NCT00956592|B1|Baseline|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
586089|NCT00956592|P2|Participant Flow|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
586090|NCT00956592|P1|Participant Flow|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
586091|NCT00956592|O2|Outcome|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
586092|NCT00956592|O1|Outcome|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
586093|NCT00956592|E2|Reported Event|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
586094|NCT00956592|E1|Reported Event|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
586095|NCT00956631|B1|Baseline|Mild Procedure|Symptomatic LSS patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
586096|NCT00956631|P1|Participant Flow|Mild Procedure|Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
586097|NCT00956631|O1|Outcome|Mild Procedure|Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated using the mild® device kit in a percutaneous lumbar decompression procedure.
586098|NCT00956631|O1|Outcome|Mild Procedure|Percutaneous lumbar decompression with the mild device kit.
586099|NCT00956631|O1|Outcome|Mild Procedure|Percutaneous decompression with the mild device kit.
586255|NCT00957047|E4|Reported Event|ESL 1200 mg|Tablets; oral route
586100|NCT00956631|E1|Reported Event|Mild Procedure|Symptomatic LSS patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
586101|NCT00956657|B3|Baseline|Total|Total of all reporting groups
586102|NCT00956657|B2|Baseline|Treatment As Usual|Control group. Treatment received as usual.
586103|NCT00956657|B1|Baseline|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
586104|NCT00956657|P2|Participant Flow|Treatment As Usual|Control group. Treatment received as usual.
586105|NCT00956657|P1|Participant Flow|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
586106|NCT00956657|O2|Outcome|Treatment As Usual|Control group. Treatment received as usual.
586107|NCT00956657|O1|Outcome|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
586108|NCT00956657|E2|Reported Event|Treatment As Usual|Control group. Treatment received as usual.
586109|NCT00956657|E1|Reported Event|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
586110|NCT00956709|B3|Baseline|Total|Total of all reporting groups
586111|NCT00956709|B2|Baseline|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
586112|NCT00956709|B1|Baseline|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
586113|NCT00956709|P2|Participant Flow|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
586114|NCT00956709|P1|Participant Flow|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
586115|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
586116|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
586117|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
586118|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
586119|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
586120|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
586121|NCT00956709|E2|Reported Event|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
586122|NCT00956709|E1|Reported Event|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
586123|NCT00956761|B1|Baseline|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
586124|NCT00956761|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
586125|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.
586126|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
586127|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
586128|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
586129|NCT00956761|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
586130|NCT00956813|B3|Baseline|Total|Total of all reporting groups
586131|NCT00956813|B2|Baseline|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
586132|NCT00956813|B1|Baseline|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
586133|NCT00956813|P2|Participant Flow|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
586134|NCT00956813|P1|Participant Flow|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
586135|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
586136|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
586137|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
586138|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
586139|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
586256|NCT00957047|E3|Reported Event|ESL 800 mg|Tablets; oral route
586141|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
586142|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
586143|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
586144|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
586145|NCT00956813|E3|Reported Event|Optional Continuation Period|After completing the Placebo/Flaxseed double-blind period, patients were allowed to continue with 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
586146|NCT00956813|E2|Reported Event|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
586147|NCT00956813|E1|Reported Event|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
586148|NCT00956839|B4|Baseline|Total|Total of all reporting groups
586149|NCT00956839|B3|Baseline|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
586150|NCT00956839|B2|Baseline|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
586151|NCT00956839|B1|Baseline|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
586152|NCT00956839|P3|Participant Flow|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
586153|NCT00956839|P2|Participant Flow|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
586154|NCT00956839|P1|Participant Flow|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
586155|NCT00956839|O3|Outcome|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
586156|NCT00956839|O2|Outcome|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
586157|NCT00956839|O1|Outcome|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
586158|NCT00956839|O3|Outcome|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
586159|NCT00956839|O2|Outcome|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
586160|NCT00956839|O1|Outcome|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
586161|NCT00956839|E3|Reported Event|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
586162|NCT00956839|E2|Reported Event|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
586163|NCT00956839|E1|Reported Event|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
586164|NCT00956943|B3|Baseline|Total|Total of all reporting groups
586165|NCT00956943|B2|Baseline|42mg Transdermal Nicotine|
586166|NCT00956943|B1|Baseline|21mg Transdermal Nicotine + Placebo Patch|
586167|NCT00956943|P2|Participant Flow|42mg Transdermal Nicotine|"42mg transdermal nicotine
Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
589346|NCT00966238|P6|Participant Flow|8.0 µg i.m.|
586169|NCT00956943|O2|Outcome|42mg Transdermal Nicotine|"42mg transdermal nicotine
Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
586170|NCT00956943|O1|Outcome|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch
Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks
placebo : placebo patch"
586171|NCT00956943|O2|Outcome|42mg Transdermal Nicotine|"42mg transdermal nicotine
Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
586172|NCT00956943|O1|Outcome|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch
Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks
placebo : placebo patch"
586173|NCT00956943|E2|Reported Event|42mg Transdermal Nicotine|"42mg transdermal nicotine
Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
586174|NCT00956943|E1|Reported Event|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch
Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks
placebo : placebo patch"
586175|NCT00957008|B5|Baseline|Total|Total of all reporting groups
586176|NCT00957008|B4|Baseline|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
586177|NCT00957008|B3|Baseline|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
586178|NCT00957008|B2|Baseline|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
586179|NCT00957008|B1|Baseline|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
586257|NCT00957047|E2|Reported Event|ESL 400 mg|Tablets; oral route
586258|NCT00957047|E1|Reported Event|Placebo|Tablets; oral route
586259|NCT00957242|B3|Baseline|Total|Total of all reporting groups
586260|NCT00957242|B2|Baseline|Warfarin|"Oral warfarin titrated to an INR of 2-3
warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
586180|NCT00957008|P4|Participant Flow|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
586181|NCT00957008|P3|Participant Flow|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
586182|NCT00957008|P2|Participant Flow|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
586183|NCT00957008|P1|Participant Flow|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
586184|NCT00957008|O4|Outcome|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
586185|NCT00957008|O3|Outcome|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
586186|NCT00957008|O2|Outcome|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
586213|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
586214|NCT00957034|O1|Outcome|Placebo|placebo patch
586215|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
586187|NCT00957008|O1|Outcome|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
586188|NCT00957008|O4|Outcome|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
586189|NCT00957008|O3|Outcome|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
586190|NCT00957008|O2|Outcome|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
586191|NCT00957008|O1|Outcome|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
586192|NCT00957008|E4|Reported Event|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
586193|NCT00957008|E3|Reported Event|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
586194|NCT00957008|E2|Reported Event|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
586261|NCT00957242|B1|Baseline|Placebo|"Oral placebo (1mg or 2.5mg)
placebo : Oral placebo (1mg or 2.5mg)"
595332|NCT00980005|B3|Baseline|Total|Total of all reporting groups
586195|NCT00957008|E1|Reported Event|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
586196|NCT00957021|B1|Baseline|Triathlon® PS Total Knee System|Participants who were not censored from analysis.
586197|NCT00957021|P1|Participant Flow|Triathlon® PS Total Knee System|If both knees were replaced, but only one knee completed the study, the participant is counted as completed.
586198|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
586199|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
586200|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
586201|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
586202|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
586203|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes participants who received the Triathlon® PS Total Knee System. Participants may have bilateral Triathlon® PS Total Knee replacement (TKR), with surgery occurring on different dates. Participants can therefore have a different status for each knee. If one knee has completed the study (i.e. has 2 year ROM data), the participant is counted in the study complete category.
586204|NCT00957021|E1|Reported Event|Triathlon® PS Total Knee System|All non-censored participants who received the Triathlon® PS Total Knee System.
586205|NCT00957034|B4|Baseline|Total|Total of all reporting groups
586206|NCT00957034|B3|Baseline|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
586207|NCT00957034|B2|Baseline|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
586208|NCT00957034|B1|Baseline|Placebo|placebo patch
586209|NCT00957034|P3|Participant Flow|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
586210|NCT00957034|P2|Participant Flow|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
586211|NCT00957034|P1|Participant Flow|Placebo|placebo patch
586212|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
586224|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
586225|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
586226|NCT00957034|O1|Outcome|Placebo|placebo patch
586227|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
586228|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
586229|NCT00957034|O1|Outcome|Placebo|placebo patch
586230|NCT00957034|E3|Reported Event|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
586231|NCT00957034|E2|Reported Event|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
586232|NCT00957034|E1|Reported Event|Placebo|placebo patch
586233|NCT00957047|B5|Baseline|Total|Total of all reporting groups
586234|NCT00957047|B4|Baseline|Placebo|placebo : once daily placebo comparator
586235|NCT00957047|B3|Baseline|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
586236|NCT00957047|B2|Baseline|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
586237|NCT00957047|B1|Baseline|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
586238|NCT00957047|P5|Participant Flow|ESL - Part II|All patients in Part II received ESL on an open-label basis, starting at 800 mg once daily.
586239|NCT00957047|P4|Participant Flow|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
586240|NCT00957047|P3|Participant Flow|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
586241|NCT00957047|P2|Participant Flow|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
586242|NCT00957047|P1|Participant Flow|Placebo|placebo : once daily placebo comparator
586243|NCT00957047|O7|Outcome|TEAE Leading to Death|
586244|NCT00957047|O6|Outcome|Serious TEAE|
586245|NCT00957047|O5|Outcome|TEAE Leading to Discontinuation|
586246|NCT00957047|O4|Outcome|Treatment-related TEAE|
586247|NCT00957047|O3|Outcome|TEAE With Onset After 1st 4 Weeks|
586248|NCT00957047|O2|Outcome|TEAE With Onset Within the 1st 4 Weeks|
586249|NCT00957047|O1|Outcome|TEAE|
586250|NCT00957047|O4|Outcome|Placebo|placebo : once daily placebo comparator
586251|NCT00957047|O3|Outcome|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
586252|NCT00957047|O2|Outcome|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
586262|NCT00957242|P2|Participant Flow|Warfarin|"Oral warfarin titrated to an INR of 2-3
warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
586263|NCT00957242|P1|Participant Flow|Placebo|"Oral placebo (1mg or 2.5mg)
placebo : Oral placebo (1mg or 2.5mg)"
586264|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
586265|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
586266|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
586267|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
586268|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
586269|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
586270|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
586271|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
586272|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
586273|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
586274|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
586275|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
586276|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
586277|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
586278|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
586279|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
586280|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
586281|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
586282|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
586283|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
586284|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
586285|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
586286|NCT00957242|O2|Outcome|Warfarin|warfarin sodium titrated to an INR of 2.0-3.0
586287|NCT00957242|O1|Outcome|Placebo|matched placebo
586288|NCT00957242|E2|Reported Event|Warfarin|"Oral warfarin titrated to an INR of 2-3
warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
586289|NCT00957242|E1|Reported Event|Placebo|"Oral placebo (1mg or 2.5mg)
placebo : Oral placebo (1mg or 2.5mg)"
586290|NCT00957268|B6|Baseline|Total|Total of all reporting groups
586291|NCT00957268|B5|Baseline|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586292|NCT00957268|B4|Baseline|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586293|NCT00957268|B3|Baseline|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586294|NCT00957268|B2|Baseline|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586295|NCT00957268|B1|Baseline|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586296|NCT00957268|P5|Participant Flow|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586297|NCT00957268|P4|Participant Flow|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586298|NCT00957268|P3|Participant Flow|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586299|NCT00957268|P2|Participant Flow|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586300|NCT00957268|P1|Participant Flow|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586301|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586302|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586303|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586304|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586305|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586306|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586307|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586308|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586309|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586310|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586311|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586312|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586313|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586314|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586315|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586316|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586317|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586318|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586319|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586320|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586321|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586670|NCT00957996|B1|Baseline|Peramivir 300mg|"300 mg twice daily
Peramivir: 300 mg twice daily"
586322|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586323|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586324|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586325|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586326|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586327|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586328|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586329|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586330|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586331|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586332|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586333|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586334|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586335|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586336|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586337|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586338|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586339|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586340|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586341|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586342|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586343|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586344|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586345|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586346|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586347|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586348|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586349|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586350|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586351|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586352|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586353|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586354|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586355|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586356|NCT00957268|E5|Reported Event|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586357|NCT00957268|E4|Reported Event|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586358|NCT00957268|E3|Reported Event|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586359|NCT00957268|E2|Reported Event|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
586360|NCT00957268|E1|Reported Event|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
586361|NCT00957333|B1|Baseline|Case|"ketamine + Cystitis
ketamine"
586362|NCT00957333|P1|Participant Flow|Case|"ketamine + Cystitis
ketamine"
586363|NCT00957333|O1|Outcome|Case|"ketamine + Cystitis
ketamine"
586364|NCT00957333|E1|Reported Event|Case|"ketamine + Cystitis
ketamine"
586365|NCT00957372|B4|Baseline|Total|Total of all reporting groups
586366|NCT00957372|B3|Baseline|Placebo|"placebo
placebo : once daily placebo comparator"
586367|NCT00957372|B2|Baseline|ESL 800mg Daily|"ESL 800mg daily
eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
586368|NCT00957372|B1|Baseline|ESL 1200mg Daily|"ESL 1200mg daily
eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
586369|NCT00957372|P4|Participant Flow|Open-label Extension (Part II)|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
586370|NCT00957372|P3|Participant Flow|Placebo|"placebo
placebo : once daily placebo comparator"
586371|NCT00957372|P2|Participant Flow|ESL 800mg Daily|"ESL 800mg daily
eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
586372|NCT00957372|P1|Participant Flow|ESL 1200mg Daily|"ESL 1200mg daily
eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
586373|NCT00957372|O7|Outcome|TEAE Leading to Death|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
586374|NCT00957372|O6|Outcome|Treatment Emergent Serious Adverse Event|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
586671|NCT00957996|P2|Participant Flow|Peramivir 600 mg|Peramivir 600 mg once daily
586375|NCT00957372|O5|Outcome|TEAE Leading to Discontinuation From the Study|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
586376|NCT00957372|O4|Outcome|Treatment-related Treatment-emergent Adverse Event|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
586377|NCT00957372|O3|Outcome|TEAE With Onset After the First 4 Weeks of Part II|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
586378|NCT00957372|O2|Outcome|TEAE With Onset Within the First 4 Weeks of Part II|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
586379|NCT00957372|O1|Outcome|TEAE|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
586380|NCT00957372|O3|Outcome|ESL 1200 mg|400 and 600 mg active substance tablets were supplied
586381|NCT00957372|O2|Outcome|ESL 800 mg|400 mg active substance tablets were supplied
586382|NCT00957372|O1|Outcome|Placebo|Placebo tablets matching the 400 and 600 mg active substance tablets were supplied.
586383|NCT00957372|E4|Reported Event|Open-label Extension (Part II)|ESL dose taken; Starting at 800 mg once daily, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg once daily or up to a maximum of 1200 mg once daily.
586384|NCT00957372|E3|Reported Event|ESL 1200 mg|400 and 600 mg active substance tablets were supplied
586385|NCT00957372|E2|Reported Event|ESL 800 mg|400 mg active substance tablets were supplied
586386|NCT00957372|E1|Reported Event|Placebo|Placebo tablets matching the 400 and 600 mg active substance tablets were supplied
586387|NCT00957424|B1|Baseline|Overall|Single-armed study
586388|NCT00957424|P1|Participant Flow|Noncombusted Nicotine Product With Informational Intervention|Single-armed study
586389|NCT00957424|O1|Outcome|Overall|Single-armed study
586390|NCT00957424|O1|Outcome|Overall|Single-armed study
586391|NCT00957424|O1|Outcome|Overall|Single-armed study
586392|NCT00957424|O1|Outcome|Overall|Single-armed study
586393|NCT00957424|E1|Reported Event|Overall|Single-armed study
586394|NCT00957528|B4|Baseline|Total|Total of all reporting groups
586395|NCT00957528|B3|Baseline|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
586396|NCT00957528|B2|Baseline|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
586397|NCT00957528|B1|Baseline|Placebo|Weekly placebo treatment for a duration of 5 months.
586398|NCT00957528|P3|Participant Flow|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
586399|NCT00957528|P2|Participant Flow|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
586400|NCT00957528|P1|Participant Flow|Placebo|Weekly placebo treatment for a duration of 5 months.
586401|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
586402|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
586403|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
586404|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
586405|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
586406|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
586407|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
586408|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
586409|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
586410|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
586411|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
586412|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
586413|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
586414|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
586415|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
586416|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
586417|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
586418|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
586419|NCT00957528|E3|Reported Event|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
586420|NCT00957528|E2|Reported Event|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
586421|NCT00957528|E1|Reported Event|Placebo|Weekly placebo treatment for a duration of 5 months.
586422|NCT00957580|B4|Baseline|Total|Total of all reporting groups
586423|NCT00957580|B3|Baseline|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586424|NCT00957580|B2|Baseline|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586425|NCT00957580|B1|Baseline|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586426|NCT00957580|P3|Participant Flow|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586427|NCT00957580|P2|Participant Flow|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586428|NCT00957580|P1|Participant Flow|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586429|NCT00957580|O2|Outcome|Regimen 2 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 21 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586430|NCT00957580|O1|Outcome|Regimen 1 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586431|NCT00957580|O3|Outcome|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586432|NCT00957580|O2|Outcome|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586433|NCT00957580|O1|Outcome|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586434|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586435|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586573|NCT00957593|B1|Baseline|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
586710|NCT00958035|P1|Participant Flow|LATISSE®|bimatoprost ophthalmic 0.03% solution
586436|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586437|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586438|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586439|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586440|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586441|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586442|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586443|NCT00957580|O1|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586603|NCT00957684|O4|Outcome|ESL 1200 mg|ESL was supplied in 400-mg and 800-mg tablets; once daily administration by oral route.
586444|NCT00957580|O8|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586445|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586446|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586447|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586448|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586449|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586450|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586451|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586452|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586453|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586454|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586574|NCT00957593|P2|Participant Flow|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
586455|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586456|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586457|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586458|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586459|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586460|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586461|NCT00957580|O1|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586462|NCT00957580|O8|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586463|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586464|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586465|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586466|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586467|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586468|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586469|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586470|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586471|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586472|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586473|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586474|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586475|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586476|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586477|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586478|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586479|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586480|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586481|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586482|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586483|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586484|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586485|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586486|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586487|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586488|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586489|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586490|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586491|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586492|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586493|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586551|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586494|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586495|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586496|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586497|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586498|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586499|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586500|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586501|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586502|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586598|NCT00957684|P5|Participant Flow|ESL - Part II|During Part II of the study all patients received ESL, including those who had been treated with placebo during Part I. The duration of treatment during Part II was one year for all patients completing the study.
586503|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586504|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586505|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586506|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586507|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586508|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586509|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586510|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586511|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586512|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586513|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586514|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586515|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586516|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586517|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586518|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586519|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586520|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586521|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586599|NCT00957684|P4|Participant Flow|Placebo|placebo : once daily placebo comparator
586600|NCT00957684|P3|Participant Flow|ESL 400 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
596069|NCT00974220|E1|Reported Event|Placebo|nebulized 0.9% saline placebo
586522|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586523|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586524|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586525|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586526|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586527|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586528|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586529|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586530|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586531|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586532|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586533|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586534|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586535|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586536|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586537|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586538|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586539|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586540|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586601|NCT00957684|P2|Participant Flow|ESL 800 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
586602|NCT00957684|P1|Participant Flow|ESL 1200 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
597746|NCT00985439|E4|Reported Event|Placebo|
586541|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586542|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586543|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586544|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586545|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586546|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586547|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586548|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586549|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586550|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586552|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586553|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586554|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586555|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586556|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586557|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586558|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586559|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586560|NCT00957580|O3|Outcome|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586561|NCT00957580|O2|Outcome|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586562|NCT00957580|O1|Outcome|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586563|NCT00957580|O2|Outcome|Regimen 2 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 21 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586564|NCT00957580|O1|Outcome|Regimen 1 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586565|NCT00957580|O3|Outcome|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586566|NCT00957580|O2|Outcome|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586567|NCT00957580|O1|Outcome|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586568|NCT00957580|E3|Reported Event|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586569|NCT00957580|E2|Reported Event|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586570|NCT00957580|E1|Reported Event|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
586571|NCT00957593|B3|Baseline|Total|Total of all reporting groups
586572|NCT00957593|B2|Baseline|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
586575|NCT00957593|P1|Participant Flow|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
586576|NCT00957593|O2|Outcome|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
586577|NCT00957593|O1|Outcome|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
586578|NCT00957593|E2|Reported Event|Oxytocin Discontinuation|Oxytocin discontinuation in the active phase of labor
586579|NCT00957593|E1|Reported Event|Oxytocin Arm|no adverse effects noted amongst the 252 patients enrolled in the study 127 in ROUTINE 125 in DISCONTINUATION ARM
586580|NCT00957658|B1|Baseline|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device
586581|NCT00957658|P1|Participant Flow|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device. Participants have one or both hips replaced. If both hips were replaced, but only one hip completed the primary endpoint, the participant is counted as completed.
586582|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
586583|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
586584|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
586585|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
586586|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
586587|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem.
586588|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
586589|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
586590|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
586591|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device
586592|NCT00957658|E1|Reported Event|Accolade TMZF Hip Stem|Participants who received the Accolade TMZF Hip Stem
586593|NCT00957684|B5|Baseline|Total|Total of all reporting groups
586594|NCT00957684|B4|Baseline|Placebo|Placebo tablets; once daily administration by oral route
586595|NCT00957684|B3|Baseline|ESL 400 mg|400-mg; once daily administration by oral route
586596|NCT00957684|B2|Baseline|ESL 800 mg|800-mg; once daily administration by oral route
586597|NCT00957684|B1|Baseline|ESL 1200 mg|400-mg + 800-mg; once daily administration by oral route
597747|NCT00985439|E3|Reported Event|Celecoxib 400 mg|
586604|NCT00957684|O3|Outcome|ESL 800 mg|ESL was supplied in 800-mg tablets; once daily administration by oral route.
586605|NCT00957684|O2|Outcome|ESL 400 mg|ESL was supplied in 400-mg tablets; once daily administration by oral route.
586606|NCT00957684|O1|Outcome|Placebo|Placebo tablets matching the 400-mg and 800-mg active substance tablets were supplied; once daily administration by oral route.
586607|NCT00957684|E4|Reported Event|Placebo|placebo : once daily placebo comparator
586608|NCT00957684|E3|Reported Event|ESL 800 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
586609|NCT00957684|E2|Reported Event|ESL 400 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
586610|NCT00957684|E1|Reported Event|ESL 1200 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
586611|NCT00957723|B1|Baseline|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.
586612|NCT00957723|P1|Participant Flow|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System can have one or both knees replaced. If both knees were replaced, but only one knee completed the study, the participant is counted as having completed.
586613|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
586614|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
586615|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
586616|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
586617|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
586618|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
586619|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
586620|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
586621|NCT00957723|E1|Reported Event|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.
586622|NCT00957905|B3|Baseline|Total|Total of all reporting groups
586623|NCT00957905|B2|Baseline|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
586624|NCT00957905|B1|Baseline|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
586625|NCT00957905|P2|Participant Flow|Part B|"6 wks: Flavopiridol:70 mg/m2/day IV 1 hr Days 1, 15 & 29. Oxaliplatin:85 mg/m2/day IV 2 hrs Days 1, 15 & 29. Leucovorin:400 mg/m2/day IV 2 hrs Days 1, 15 & 29.
5-FU: 400 mg/m2 IV 15 min, and 1800 mg/m2 IV 48 hrs Days 1-2, 15-16 & 29-30."
586626|NCT00957905|P1|Participant Flow|Part A|6 weeks: Flavopiridol: 70 mg/m2/day IV over 1 hr on days 1, 15 and 29. Oxaliplatin: 85 mg/m2/day IV over 2 hrs on days 1, 15 and 29.
586627|NCT00957905|O2|Outcome|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
586628|NCT00957905|O1|Outcome|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
586629|NCT00957905|E2|Reported Event|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
586630|NCT00957905|E1|Reported Event|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
586631|NCT00957944|B3|Baseline|Total|Total of all reporting groups
586632|NCT00957944|B2|Baseline|Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)|Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
586633|NCT00957944|B1|Baseline|Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)|Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)
586634|NCT00957944|P2|Participant Flow|Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)|Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
586635|NCT00957944|P1|Participant Flow|Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)|Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)
586636|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586637|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586638|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586639|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586640|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586641|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586642|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586643|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586644|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586645|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586646|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586647|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586648|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586649|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586650|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586651|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586652|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586653|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586654|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586655|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586711|NCT00958035|O2|Outcome|Placebo|vehicle sterile solution
586656|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586657|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586658|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586659|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586660|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586661|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586662|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586663|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586664|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586665|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586666|NCT00957944|E2|Reported Event|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
586667|NCT00957944|E1|Reported Event|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
586668|NCT00957996|B3|Baseline|Total|Total of all reporting groups
586669|NCT00957996|B2|Baseline|Peramivir 600mg|"600 mg once daily
Peramivir: 600 mg once daily"
586672|NCT00957996|P1|Participant Flow|Peramivir 300 mg|Peramivir 300 mg twice daily
586673|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
586674|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
586675|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily
Peramivir: 600 mg once daily"
586676|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily
Peramivir: 300 mg twice daily"
586677|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
586678|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
586679|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
586680|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
586681|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
586682|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
586683|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
586684|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
586685|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
586686|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
586687|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
586688|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
586689|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
586690|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
586691|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily
Peramivir: 600 mg once daily"
586692|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily
Peramivir: 300 mg twice daily"
586693|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
586694|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
586695|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
586696|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
586697|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily
Peramivir: 600 mg once daily"
586698|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily
Peramivir: 300 mg twice daily"
586699|NCT00957996|E2|Reported Event|Peramivir 600 mg|"600 mg once daily
Peramivir: 600 mg once daily"
586700|NCT00957996|E1|Reported Event|Peramivir 300 mg|"300 mg twice daily
Peramivir: 300 mg twice daily"
586701|NCT00958009|B1|Baseline|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
586702|NCT00958009|P1|Participant Flow|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
586703|NCT00958009|O1|Outcome|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
586704|NCT00958009|O1|Outcome|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
586705|NCT00958009|E1|Reported Event|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
586706|NCT00958035|B3|Baseline|Total|Total of all reporting groups
586707|NCT00958035|B2|Baseline|Placebo|vehicle sterile solution
586708|NCT00958035|B1|Baseline|LATISSE®|bimatoprost ophthalmic 0.03% solution
586709|NCT00958035|P2|Participant Flow|Placebo|vehicle sterile solution
586712|NCT00958035|O1|Outcome|LATISSE®|bimatoprost ophthalmic 0.03% solution
586713|NCT00958035|E2|Reported Event|Placebo|vehicle sterile solution
586714|NCT00958035|E1|Reported Event|LATISSE®|bimatoprost ophthalmic 0.03% solution
586715|NCT00958074|B3|Baseline|Total|Total of all reporting groups
586716|NCT00958074|B2|Baseline|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.
vorinostat: Given PO
flow cytometry: correlative study
laboratory biomarker analysis: correlative study"
586717|NCT00958074|B1|Baseline|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.
vorinostat: Given PO
flow cytometry: correlative study
laboratory biomarker analysis: correlative study"
586718|NCT00958074|P2|Participant Flow|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.
vorinostat: Given PO
flow cytometry: correlative study
laboratory biomarker analysis: correlative study"
586719|NCT00958074|P1|Participant Flow|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.
vorinostat: Given PO
flow cytometry: correlative study
laboratory biomarker analysis: correlative study"
586720|NCT00958074|O2|Outcome|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.
vorinostat: Given PO
flow cytometry: correlative study
laboratory biomarker analysis: correlative study"
586721|NCT00958074|O1|Outcome|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.
vorinostat: Given PO
flow cytometry: correlative study
laboratory biomarker analysis: correlative study"
586773|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586774|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
597748|NCT00985439|E2|Reported Event|Diclofenac Test (Upper Dose)|
586722|NCT00958074|E2|Reported Event|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.
vorinostat: Given PO
flow cytometry: correlative study
laboratory biomarker analysis: correlative study"
586723|NCT00958074|E1|Reported Event|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.
vorinostat: Given PO
flow cytometry: correlative study
laboratory biomarker analysis: correlative study"
586724|NCT00958126|B9|Baseline|Total|Total of all reporting groups
586725|NCT00958126|B8|Baseline|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586726|NCT00958126|B7|Baseline|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586727|NCT00958126|B6|Baseline|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586728|NCT00958126|B5|Baseline|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
586729|NCT00958126|B4|Baseline|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586730|NCT00958126|B3|Baseline|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586731|NCT00958126|B2|Baseline|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586732|NCT00958126|B1|Baseline|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
586733|NCT00958126|P8|Participant Flow|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586734|NCT00958126|P7|Participant Flow|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586735|NCT00958126|P6|Participant Flow|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586736|NCT00958126|P5|Participant Flow|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
586737|NCT00958126|P4|Participant Flow|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586738|NCT00958126|P3|Participant Flow|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586739|NCT00958126|P2|Participant Flow|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586740|NCT00958126|P1|Participant Flow|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
586741|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Age Cohorts Combined|30 mcg of hemagglutinin antigen per dose
586742|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Age Cohorts Combined|15 mcg of hemagglutinin antigen per dose
586743|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Age Cohorts Combined|7.5 mcg of hemagglutinin antigen per dose
586744|NCT00958126|O1|Outcome|Placebo, Age Cohorts Combined|Vaccine diluent
586745|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586746|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586747|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586748|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
586749|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586750|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
589347|NCT00966238|P5|Participant Flow|5.0 µg i.m.|
586751|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586752|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
586753|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586754|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586755|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586756|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
586757|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586758|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586759|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586760|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
586761|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586762|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586763|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586764|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
586765|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586766|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586767|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586768|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
586769|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586770|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586771|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586772|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
586775|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586776|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
586777|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586778|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586779|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586780|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
586781|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586782|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586783|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586784|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
586785|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586786|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586787|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586788|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
586789|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586790|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586791|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586792|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
586793|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586794|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586795|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586796|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
586797|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586798|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586799|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586800|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
586801|NCT00958126|E8|Reported Event|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586802|NCT00958126|E7|Reported Event|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586803|NCT00958126|E6|Reported Event|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
586804|NCT00958126|E5|Reported Event|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
586805|NCT00958126|E4|Reported Event|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586806|NCT00958126|E3|Reported Event|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586807|NCT00958126|E2|Reported Event|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
586808|NCT00958126|E1|Reported Event|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
586809|NCT00958165|B1|Baseline|EAS-AC|"PVI with EAS-AC
CardioFocus EAS-AC: PVI for PAF"
586810|NCT00958165|P1|Participant Flow|EAS-AC|"PVI with EAS-AC
CardioFocus EAS-AC: PVI for PAF"
586811|NCT00958165|O1|Outcome|EAS-AC|Pulmonary vein isolation treatment with EAS-AC for PAF
586812|NCT00958165|E1|Reported Event|EAS-AC|"PVI with EAS-AC
CardioFocus EAS-AC: PVI for PAF"
586813|NCT00958191|B1|Baseline|Trident® X3 Polyethylene Insert|All subjects who recieved the Trident X3 insert.
586814|NCT00958191|P1|Participant Flow|Trident® X3 Polyethylene Insert|Participants who received the Trident X3 polyetheylene insert can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed.
586815|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
586816|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
586817|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
586818|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
586819|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
586820|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
586821|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
586822|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
586823|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
586824|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received theTrident® X3 Polyethylene Insert
586825|NCT00958191|E1|Reported Event|Trident® X3 Polyethylene Insert|Participants who received the Trident X3 Polyethylene Insert
586826|NCT00958217|B3|Baseline|Total|Total of all reporting groups
586850|NCT00958243|P3|Participant Flow|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
597749|NCT00985439|E1|Reported Event|Diclofenac Test (Lower Dose)|
586827|NCT00958217|B2|Baseline|Arm 2: ICBT|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) were recruited.
ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
586828|NCT00958217|B1|Baseline|Arm 1: CPT-M|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) were recruited.
CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
586829|NCT00958217|P2|Participant Flow|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.
ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
586830|NCT00958217|P1|Participant Flow|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.
CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
586831|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.
ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
586832|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.
CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
586833|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.
ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
586834|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.
CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
586835|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.
ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
586884|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose
586885|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo
586836|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.
CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
586837|NCT00958217|E3|Reported Event|ICBT Prior to Randomization|"All participants attended 12 weeks of group Integrated Cognitive Behavioral Therapy prior to randomization to provide for a period of stabilization and to develop relapse prevention and mood management skills.
This portion will report on only those participants who were not randomized to individual CPT-M or ICBT."
586838|NCT00958217|E2|Reported Event|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.
ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
586839|NCT00958217|E1|Reported Event|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.
CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
586840|NCT00958243|B7|Baseline|Total|Total of all reporting groups
586841|NCT00958243|B6|Baseline|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586842|NCT00958243|B5|Baseline|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586843|NCT00958243|B4|Baseline|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
586844|NCT00958243|B3|Baseline|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586845|NCT00958243|B2|Baseline|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586846|NCT00958243|B1|Baseline|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
586847|NCT00958243|P6|Participant Flow|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586848|NCT00958243|P5|Participant Flow|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586849|NCT00958243|P4|Participant Flow|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
586851|NCT00958243|P2|Participant Flow|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586852|NCT00958243|P1|Participant Flow|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
586853|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586854|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586855|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
586856|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586857|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586858|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
586859|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586860|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586861|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
586862|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586863|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586864|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
586865|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose
586866|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose
586867|NCT00958243|O1|Outcome|Placebo Cohort B|Placebo
586868|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586869|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586870|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
586871|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586872|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586873|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
586874|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586875|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586876|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
586877|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586878|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586879|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
586880|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose
586881|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose
586882|NCT00958243|O1|Outcome|Placebo Cohort B|Placebo
586883|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose
586886|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose
586887|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose
586888|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo
586889|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586890|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586891|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
586892|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586893|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586894|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
586895|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586896|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586897|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
586898|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586899|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586900|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
586901|NCT00958243|E6|Reported Event|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586902|NCT00958243|E5|Reported Event|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
586903|NCT00958243|E4|Reported Event|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
586904|NCT00958243|E3|Reported Event|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586905|NCT00958243|E2|Reported Event|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
586906|NCT00958243|E1|Reported Event|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
586936|NCT00958334|B3|Baseline|Placebo Comparator|Placebo capsule once daily
586937|NCT00958334|B2|Baseline|Proellex 12.5 mg|Proellex® 12.5 mg once daily
586938|NCT00958334|B1|Baseline|Proellex 25 mg|Proellex® 12.5 mg twice daily
586907|NCT00958256|B1|Baseline|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
586908|NCT00958256|P1|Participant Flow|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, Granulocyte-colony stimulating factor (G-CSF) 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
586909|NCT00958256|O1|Outcome|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
586910|NCT00958256|E1|Reported Event|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
586911|NCT00958282|B3|Baseline|Total|Total of all reporting groups
586912|NCT00958282|B2|Baseline|Placebo|"Placebo Comparator once per day
placebo
cognitive behavioral therapy"
586913|NCT00958282|B1|Baseline|Lisdexamfetamine|"lisdexamfetamine 70mg/day
lisdexamfetamine
cognitive behavioral therapy"
586914|NCT00958282|P2|Participant Flow|Placebo|"Placebo Comparator once per day
placebo
cognitive behavioral therapy"
586915|NCT00958282|P1|Participant Flow|Lisdexamfetamine|"lisdexamfetamine 70mg/day
lisdexamfetamine
cognitive behavioral therapy"
586916|NCT00958282|O2|Outcome|Placebo|"Placebo Comparator once per day
placebo
cognitive behavioral therapy"
586917|NCT00958282|O1|Outcome|Lisdexamfetamine|"lisdexamfetamine 70mg/day
lisdexamfetamine
cognitive behavioral therapy"
586918|NCT00958282|O2|Outcome|Placebo|"Placebo Comparator once per day
placebo
cognitive behavioral therapy"
586919|NCT00958282|O1|Outcome|Lisdexamfetamine|"lisdexamfetamine 70mg/day
lisdexamfetamine
cognitive behavioral therapy"
586920|NCT00958282|E2|Reported Event|Placebo|"Placebo Comparator once per day
placebo"
586921|NCT00958282|E1|Reported Event|Lisdexamfetamine/Behavior Therapy|"lisdexamfetamine 70mg/day plus Behavior Therapy
lisdexamfetamine/Behavior Therapy"
586922|NCT00958308|B4|Baseline|Total|Total of all reporting groups
586923|NCT00958308|B3|Baseline|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
586924|NCT00958308|B2|Baseline|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
586925|NCT00958308|B1|Baseline|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
587282|NCT00951665|P2|Participant Flow|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
586926|NCT00958308|P3|Participant Flow|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
586927|NCT00958308|P2|Participant Flow|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
586928|NCT00958308|P1|Participant Flow|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
586929|NCT00958308|O3|Outcome|BIO-K+ CL-1285|Two capsules of probiotic (each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
586930|NCT00958308|O2|Outcome|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
586931|NCT00958308|O1|Outcome|Placebo|Two capsules of placebo (devoid of microorganisms)per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
586932|NCT00958308|E3|Reported Event|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
586933|NCT00958308|E2|Reported Event|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
586934|NCT00958308|E1|Reported Event|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
586935|NCT00958334|B4|Baseline|Total|Total of all reporting groups
586939|NCT00958334|P3|Participant Flow|Placebo Comparator|Placebo capsules orally QD
586940|NCT00958334|P2|Participant Flow|Proellex 12.5 mg|Proellex® 12.5 mg capsules orally QD
586941|NCT00958334|P1|Participant Flow|Proellex 25 mg|Proellex® 12.5 mg orally capsules BID
586942|NCT00958334|O3|Outcome|Placebo Comparator|Placebo capsule once daily
586943|NCT00958334|O2|Outcome|Proellex 12.5 mg|Proellex® 12.5 mg once daily
586944|NCT00958334|O1|Outcome|Proellex 25 mg|Proellex® 12.5 mg twice daily
586945|NCT00958334|E3|Reported Event|Placebo Comparator|Placebo capsule once daily
586946|NCT00958334|E2|Reported Event|Proellex 12.5 mg|Proellex® 12.5 mg once daily
586947|NCT00958334|E1|Reported Event|Proellex 25 mg|Proellex® 12.5 mg twice daily
586948|NCT00958347|B1|Baseline|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
586949|NCT00958347|P1|Participant Flow|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem.
586950|NCT00958347|O1|Outcome|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
586951|NCT00958347|E1|Reported Event|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
586952|NCT00958360|B3|Baseline|Total|Total of all reporting groups
586953|NCT00958360|B2|Baseline|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
586954|NCT00958360|B1|Baseline|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
586955|NCT00958360|P2|Participant Flow|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
586956|NCT00958360|P1|Participant Flow|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
586957|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
586978|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
587416|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
586958|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
586959|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
586960|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
586961|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
586962|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
586963|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
586964|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
587191|NCT00951379|B1|Baseline|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
586965|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
586966|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
586967|NCT00958360|E2|Reported Event|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.
Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
586968|NCT00958360|E1|Reported Event|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
586969|NCT00958438|B4|Baseline|Total|Total of all reporting groups
586970|NCT00958438|B3|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
586971|NCT00958438|B2|Baseline|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
586972|NCT00958438|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
586973|NCT00958438|P3|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
586974|NCT00958438|P2|Participant Flow|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
586975|NCT00958438|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
586976|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
586977|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
587417|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
586979|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
586980|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
586981|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
586982|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
586983|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
586984|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
586985|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
586986|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
586987|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
586988|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
586989|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
586990|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
586991|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
586992|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
587192|NCT00951379|P2|Participant Flow|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
586993|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
586994|NCT00958438|E3|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
586995|NCT00958438|E2|Reported Event|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
586996|NCT00958438|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
586997|NCT00958477|B5|Baseline|Total|Total of all reporting groups
586998|NCT00958477|B4|Baseline|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
586999|NCT00958477|B3|Baseline|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587000|NCT00958477|B2|Baseline|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587001|NCT00958477|B1|Baseline|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587002|NCT00958477|P4|Participant Flow|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587003|NCT00958477|P3|Participant Flow|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587004|NCT00958477|P2|Participant Flow|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587170|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587005|NCT00958477|P1|Participant Flow|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587006|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587007|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587008|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587009|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587010|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587011|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587012|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587208|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
587013|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587014|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587015|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587016|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587017|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587018|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587019|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587020|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587021|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587280|NCT00951665|P4|Participant Flow|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587022|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587023|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587024|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587025|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587026|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587027|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587028|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587029|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587193|NCT00951379|P1|Participant Flow|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
587194|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
587030|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587031|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587032|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587033|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587034|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587035|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587036|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587037|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587038|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587039|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587040|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587041|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587042|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587043|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587044|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587045|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587046|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587195|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
587196|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
587047|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587048|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587049|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587050|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587051|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587052|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587053|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587054|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587055|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587056|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587057|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587058|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587059|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587060|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587061|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587062|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587063|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587197|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
587198|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
587064|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587065|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587066|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587067|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587068|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587069|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587070|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587071|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587072|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587073|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587074|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587075|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587076|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587077|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587078|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587079|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587080|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587199|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
587200|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
587081|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587082|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587083|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587084|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587085|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587086|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587087|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587088|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587089|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587090|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587091|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587092|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587093|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587094|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587095|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587096|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587097|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587201|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
598350|NCT00986349|O3|Outcome|EndoBarrier Liner Device % at 6 Months|HbA1c
587098|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587099|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587100|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587101|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587102|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587103|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587104|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587105|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587106|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587107|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587108|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587109|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587110|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587111|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587112|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587113|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587114|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587202|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
587203|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
587115|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587116|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587117|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587118|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587119|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587120|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587121|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587122|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587123|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587124|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587125|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587126|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587127|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587128|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587129|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587130|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587131|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587204|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
587205|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
587132|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587133|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587134|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587135|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587136|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587137|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587138|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587139|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587140|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587141|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587142|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587143|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587144|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587145|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587146|NCT00958477|E4|Reported Event|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587147|NCT00958477|E3|Reported Event|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587148|NCT00958477|E2|Reported Event|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587206|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
587207|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
587149|NCT00958477|E1|Reported Event|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
587150|NCT00951171|B3|Baseline|Total|Total of all reporting groups
587151|NCT00951171|B2|Baseline|Standard IUI|Insemination with TOmcat catheter
587152|NCT00951171|B1|Baseline|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
587153|NCT00951171|P2|Participant Flow|Standard IUI|Insemination with TOmcat catheter
587154|NCT00951171|P1|Participant Flow|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
587155|NCT00951171|O2|Outcome|Standard IUI|Insemination with TOmcat catheter
587156|NCT00951171|O1|Outcome|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
587157|NCT00951171|E2|Reported Event|Standard IUI|Insemination with TOmcat catheter
587158|NCT00951171|E1|Reported Event|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
587159|NCT00951275|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587160|NCT00951275|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (maximum dose 800 mg) intravenously (IV) once every 4 weeks for a total of 6 infusions.
587161|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587162|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587163|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587164|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587165|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587166|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587167|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587168|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587169|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587171|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587172|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587173|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587174|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587175|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587176|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587177|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587178|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587179|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587180|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587181|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587182|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587183|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587184|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587185|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587186|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587187|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587188|NCT00951275|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
587189|NCT00951379|B3|Baseline|Total|Total of all reporting groups
587190|NCT00951379|B2|Baseline|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
598868|NCT00988156|B3|Baseline|Total|Total of all reporting groups
587209|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
587210|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
587211|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
587212|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
587213|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
587214|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
587215|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
587216|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
587217|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
587218|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
587219|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
587220|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
587221|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
587222|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
587223|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
587224|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
587225|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
587226|NCT00951379|O4|Outcome|Placebo: CRP>5 End of Study|Measure at end of Placebo treatment, approximately 24 weeks
587227|NCT00951379|O3|Outcome|Placebo: CRP> 5 Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
587228|NCT00951379|O2|Outcome|Pioglitazone: CRP>5 End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
587229|NCT00951379|O1|Outcome|Pioglitazone: CRP>5 at Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
587230|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
587231|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
587232|NCT00951379|E2|Reported Event|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
587233|NCT00951379|E1|Reported Event|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
587234|NCT00951483|B3|Baseline|Total|Total of all reporting groups
587235|NCT00951483|B2|Baseline|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
587236|NCT00951483|B1|Baseline|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587237|NCT00951483|P2|Participant Flow|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
587238|NCT00951483|P1|Participant Flow|Intervention Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587239|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587240|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587241|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587242|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587243|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587305|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
589298|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
587244|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587245|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587246|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587247|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587248|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587249|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587250|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587251|NCT00951483|O2|Outcome|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
587252|NCT00951483|O1|Outcome|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587281|NCT00951665|P3|Participant Flow|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
589348|NCT00966238|P4|Participant Flow|3.0 µg i.m.|
587253|NCT00951483|E2|Reported Event|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
587254|NCT00951483|E1|Reported Event|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.
Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
587255|NCT00951509|B1|Baseline|All Subjects|"Power Mobility Road Test (PMRT): All subjects were asked to complete the real world power mobility evaluation via the PMRT.
Computer-Based Test: All subjects were asked to complete the computer-based evaluation designed to simulate real world driving in a 2D environment.
Virtual Reality Test: All subjects were asked to complete the virtual-based evaluation designed to simulate real world driving in a 3D environment."
587256|NCT00951509|P1|Participant Flow|Participants Who Qualified for the Study|All participants who qualified for the study, performed electric power wheelchair (EPW) driving under five driving conditions, while clinicians observed and assessed the EPW users' driving performance. The first four conditions were conducted in virtual environments (with different interfaces in each condition, as listed below) and condition 5 was conducted in the real world - Condition 1 - Desktop screens with no roller systems Condition 2- Desktop screens with roller systems Condition 3 - Immersive virtual reality screens with no roller systems Condition 4 - Immersive virtual reality screens with roller systems Condition 5 - Real world EPW driving
587257|NCT00951509|O5|Outcome|Condition 5|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
587258|NCT00951509|O4|Outcome|Condition 4|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
587259|NCT00951509|O3|Outcome|Condition 3|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
587260|NCT00951509|O2|Outcome|Condition 2|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
587261|NCT00951509|O1|Outcome|Condition 1|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
587306|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587307|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587262|NCT00951509|E1|Reported Event|Power Mobility Road Test|With 12 structured tasks and 4 dynamic tasks, adding to a total of 16 tasks with a minimum score of 1 and maximum of 4 in each task, it is possible to score in the range of 16 - 64 during a driving trial. To assess the driving performance, the total score for each trial was calculated and expressed as a percentage, termed “Composite score”. A Composite score of 95 % or greater would suggest that the user is a safe driver.
587263|NCT00951561|B1|Baseline|Study Participants|Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
587264|NCT00951561|P4|Participant Flow|Ibuprofen/Vipon/Vipon/Ibuprofen|
587265|NCT00951561|P3|Participant Flow|Vipon/Ibuprofen/Ibuprofen/Vipon|
587266|NCT00951561|P2|Participant Flow|Ibuprofen/Vipon/Ibuprofen/Vipon|
587267|NCT00951561|P1|Participant Flow|Vipon/Ibuprofen/Vipon/Ibuprofen|Subjects participated for a total of 4 menstrual cycles. Subjects used either VIPON as a medical device or up to 2 ibuprofen tablets (each tablet containing 200 mg ibuprofen) during the first menstrual cycle. Subjects used crossover treatment during second menstrual cycle, randomized for cycle 3, and crossed over for cycle 4. All subjects used tampons for absorption of menstrual fluid during treatment and at least 2 hours post treatment. Subjects taking ibuprofen also used a tampon during treatment.
587268|NCT00951561|O2|Outcome|Ibuprofen|Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
587269|NCT00951561|O1|Outcome|VIPON|Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
587270|NCT00951561|E1|Reported Event|Study Participants|Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
587271|NCT00951665|B7|Baseline|Total|Total of all reporting groups
587272|NCT00951665|B6|Baseline|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously.
587273|NCT00951665|B5|Baseline|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously.
587274|NCT00951665|B4|Baseline|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587275|NCT00951665|B3|Baseline|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
587276|NCT00951665|B2|Baseline|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587277|NCT00951665|B1|Baseline|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587278|NCT00951665|P6|Participant Flow|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously.
587279|NCT00951665|P5|Participant Flow|Phase IIa Group A|Participants received maximum tolerated dose (MTD) from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously.
587418|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
587283|NCT00951665|P1|Participant Flow|Phase Ib Regimen 1|Participants received trastuzumab emtansine (T-DM1) every three weeks (Q3W) + paclitaxel weekly (QW) intravenously.
587284|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
587285|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
587286|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587287|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
587288|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587289|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587290|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
587291|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
587292|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587293|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
587294|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587295|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587296|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
587297|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
587298|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587299|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
587300|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587301|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587302|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
587303|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
587304|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587308|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
587309|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
587310|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587311|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
587312|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587313|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587314|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
587315|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
587316|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
587317|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
587318|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
587319|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
587320|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587321|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587322|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587323|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587324|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
587325|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587326|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587327|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587328|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587329|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
587330|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587331|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587332|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587333|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
587334|NCT00951665|O6|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587335|NCT00951665|O5|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587336|NCT00951665|O4|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587337|NCT00951665|O3|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
587338|NCT00951665|O2|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587339|NCT00951665|O1|Outcome|Phase Ib Cohort A|Participants received 2 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
587340|NCT00951665|O5|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587341|NCT00951665|O4|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587342|NCT00951665|O3|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587343|NCT00951665|O2|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
587344|NCT00951665|O1|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587345|NCT00951665|O6|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587346|NCT00951665|O5|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587347|NCT00951665|O4|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587348|NCT00951665|O3|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
587349|NCT00951665|O2|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
587350|NCT00951665|O1|Outcome|Phase Ib Cohort A|Participants received 2 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
587351|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received of T-DM1 3.6mg/kg Q3W, paclitaxel 80mg/m^2 QW, and pertuzumab Q3W intravenously.
587352|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
587353|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587354|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
587355|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587356|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587357|NCT00951665|O2|Outcome|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W, paclitaxel 80mg/m^2 QW, and pertuzumab 420 mg Q3W intravenously.
587358|NCT00951665|O1|Outcome|Phase IIa Group A|Participants received MTD from Phase Ib i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
587359|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587360|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
587361|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587362|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587363|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587364|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
587365|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587366|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587367|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587368|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
587369|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587370|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587371|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
587372|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
587373|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587374|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
587375|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587376|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587377|NCT00951665|E6|Reported Event|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
587378|NCT00951665|E5|Reported Event|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
587379|NCT00951665|E4|Reported Event|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
587380|NCT00951665|E3|Reported Event|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
587381|NCT00951665|E2|Reported Event|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
587382|NCT00951665|E1|Reported Event|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
587383|NCT00951808|B1|Baseline|All Participants|237 subjects enrolled in the feasibility study.
587384|NCT00951808|P3|Participant Flow|Standard Care Observational Cohort|Subjects who are ineligible for or who decline the blood transfusion part of the study participated in the observational portion of the study and received standard care (regular care for acute chest syndrome (ACS)).
587385|NCT00951808|P2|Participant Flow|Standard Care Trial Cohort|Subjects received standard care (regular care for acute chest syndrome (ACS)) without a clinically indicated transfusion.
587386|NCT00951808|P1|Participant Flow|Blood Transfusion Trial Cohort|Subjects received a transfusion within 6 hours of randomization.
587387|NCT00951808|O3|Outcome|Overall|Both adults and children
587388|NCT00951808|O2|Outcome|Children|Age < 18
587389|NCT00951808|O1|Outcome|Adults|Age >= 18
587390|NCT00951808|E1|Reported Event|Blood Transfusion Trial Cohort|Subjects received a transfusion within 6 hours of randomization.
587391|NCT00951821|B3|Baseline|Total|Total of all reporting groups
587392|NCT00951821|B2|Baseline|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.
Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
587393|NCT00951821|B1|Baseline|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
587394|NCT00951821|P2|Participant Flow|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.
Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
587395|NCT00951821|P1|Participant Flow|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
587396|NCT00951821|O2|Outcome|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.
Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
587397|NCT00951821|O1|Outcome|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
587398|NCT00951821|O2|Outcome|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.
Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
587399|NCT00951821|O1|Outcome|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
587400|NCT00951821|E2|Reported Event|Adolescent Treatment Only|"Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.
Adolescent treatment only: Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
587401|NCT00951821|E1|Reported Event|Concurrent Treatment|"Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
Concurrent treatment: Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
587402|NCT00951899|B3|Baseline|Total|Total of all reporting groups
587403|NCT00951899|B2|Baseline|Placebo|Placebo plus diet and metformin
587404|NCT00951899|B1|Baseline|Colesevelam|Treatment with colesevelam in addition to metformin and diet
587405|NCT00951899|P2|Participant Flow|Placebo|Placebo plus diet and metformin
587406|NCT00951899|P1|Participant Flow|Colesevelam|Treatment with colesevelam in addition to metformin and diet
587407|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
587408|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
587409|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
587410|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
587411|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
587412|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
587413|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
587414|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
587415|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
587420|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
587421|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
587422|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
587423|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
587424|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
587425|NCT00951899|E2|Reported Event|Placebo|Placebo plus diet and metformin
587426|NCT00951899|E1|Reported Event|Colesevelam|Treatment with colesevelam in addition to metformin and diet
587427|NCT00951912|B4|Baseline|Total|Total of all reporting groups
587428|NCT00951912|B3|Baseline|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
587429|NCT00951912|B2|Baseline|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
587430|NCT00951912|B1|Baseline|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
587431|NCT00951912|P3|Participant Flow|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
587432|NCT00951912|P2|Participant Flow|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
587433|NCT00951912|P1|Participant Flow|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
587434|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587435|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587436|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587437|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587438|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587439|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587440|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587441|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587442|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587443|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587444|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587445|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587446|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587447|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587448|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587449|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587450|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587451|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587452|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587453|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587454|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587455|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587456|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587457|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587458|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587459|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587460|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587461|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587462|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587463|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587464|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587465|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587466|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587467|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587468|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587469|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587470|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587471|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587472|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587473|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587474|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587475|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587476|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
587477|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
587478|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
587479|NCT00951912|E3|Reported Event|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
587480|NCT00951912|E2|Reported Event|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
587481|NCT00951912|E1|Reported Event|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
587482|NCT00952068|B1|Baseline|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
587483|NCT00952068|P1|Participant Flow|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
587484|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
587485|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
587486|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
587487|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
587488|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
587489|NCT00952068|E1|Reported Event|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
587490|NCT00952081|B1|Baseline|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
587491|NCT00952081|P1|Participant Flow|Clevidipine,Brain Tumor,Hypertension|Clevidipine(0.5 mg/mL in 20% lipid solution), initiated at 10 mg/h and titrated to effect, was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.
599890|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
587492|NCT00952081|O1|Outcome|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
587493|NCT00952081|E1|Reported Event|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
587494|NCT00952120|B4|Baseline|Total|Total of all reporting groups
587495|NCT00952120|B3|Baseline|GSUC and Vacuum-assisted Closure|These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
587496|NCT00952120|B2|Baseline|Vacuum-assisted Closure|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
587497|NCT00952120|B1|Baseline|GSUC|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
587498|NCT00952120|P3|Participant Flow|GSUC and Vacuum-assisted Closure|These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
587499|NCT00952120|P2|Participant Flow|Vacuum-assisted Closure|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
587500|NCT00952120|P1|Participant Flow|GSUC|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
587501|NCT00952120|O2|Outcome|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days
VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
587502|NCT00952120|O1|Outcome|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days
GSUC: Gauze-based wall suction negative pressure wound therapy"
587503|NCT00952120|O2|Outcome|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days
VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
587504|NCT00952120|O1|Outcome|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days
GSUC: Gauze-based wall suction negative pressure wound therapy"
587505|NCT00952120|E2|Reported Event|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days
VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
587506|NCT00952120|E1|Reported Event|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days
GSUC: Gauze-based wall suction negative pressure wound therapy"
587507|NCT00952133|B3|Baseline|Total|Total of all reporting groups
587508|NCT00952133|B2|Baseline|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
587509|NCT00952133|B1|Baseline|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
587510|NCT00952133|P2|Participant Flow|Palonosetron With Placebo|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
587511|NCT00952133|P1|Participant Flow|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
587512|NCT00952133|O2|Outcome|Placebo|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
587513|NCT00952133|O1|Outcome|Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
587514|NCT00952133|O2|Outcome|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
587515|NCT00952133|O1|Outcome|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
587516|NCT00952133|E2|Reported Event|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
587517|NCT00952133|E1|Reported Event|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
587518|NCT00952211|B3|Baseline|Total|Total of all reporting groups
587519|NCT00952211|B2|Baseline|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure
CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
587520|NCT00952211|B1|Baseline|CPAP|"CPAP at therapeutic pressure
CPAP: CPAP at therapeutic pressure during nighttime"
587521|NCT00952211|P2|Participant Flow|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure
CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
587522|NCT00952211|P1|Participant Flow|CPAP|"CPAP at therapeutic pressure
CPAP: CPAP at therapeutic pressure during nighttime"
587523|NCT00952211|O2|Outcome|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure
CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
587524|NCT00952211|O1|Outcome|CPAP|"CPAP at therapeutic pressure
CPAP: CPAP at therapeutic pressure during nighttime"
587525|NCT00952211|O2|Outcome|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure
CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
587526|NCT00952211|O1|Outcome|CPAP|"CPAP at therapeutic pressure
CPAP: CPAP at therapeutic pressure during nighttime"
589216|NCT00955955|O1|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase I|Patients who received Deplin (L-methylfolate) for 4 weeks
587527|NCT00952211|E2|Reported Event|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure
CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
587528|NCT00952211|E1|Reported Event|CPAP|"CPAP at therapeutic pressure
CPAP: CPAP at therapeutic pressure during nighttime"
587529|NCT00952276|B6|Baseline|Total|Total of all reporting groups
587530|NCT00952276|B5|Baseline|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
587531|NCT00952276|B4|Baseline|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
587532|NCT00952276|B3|Baseline|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
587533|NCT00952276|B2|Baseline|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
587534|NCT00952276|B1|Baseline|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
587535|NCT00952276|P5|Participant Flow|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
587536|NCT00952276|P4|Participant Flow|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
587537|NCT00952276|P3|Participant Flow|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
587538|NCT00952276|P2|Participant Flow|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
587539|NCT00952276|P1|Participant Flow|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
587540|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
587541|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
587542|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
587543|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
587544|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
587545|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
587546|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
587547|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
587548|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
587549|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
587550|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
587551|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
587552|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
587553|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
587554|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
587555|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
587556|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
587557|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
587558|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
587559|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
587560|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
587561|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
587562|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
587563|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
587564|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
587565|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
587566|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
587567|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
587568|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
587569|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
587570|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
587571|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
587572|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
587573|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
587574|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
587575|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
587576|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
587577|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
587578|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
587579|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
587580|NCT00952276|E5|Reported Event|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
587581|NCT00952276|E4|Reported Event|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
587582|NCT00952276|E3|Reported Event|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
587583|NCT00952276|E2|Reported Event|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
587584|NCT00952276|E1|Reported Event|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
587585|NCT00952289|B3|Baseline|Total|Total of all reporting groups
587586|NCT00952289|B2|Baseline|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587587|NCT00952289|B1|Baseline|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587588|NCT00952289|P2|Participant Flow|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587613|NCT00952341|B2|Baseline|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin"
587589|NCT00952289|P1|Participant Flow|Ruxolitinib|Participants received ruxolitinib orally twice a day. The starting dose was based on Baseline platelet count. Patients with Baseline platelet count > 200,000/μL began a dose regimen of 20 mg twice daily. Patients with Baseline platelet count of 100,000/μL to 200,000/μL (inclusive) began a dose regimen of 15 mg twice daily. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily. Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).
587590|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587591|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587592|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587593|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587594|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587595|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587596|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587597|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587598|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587599|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587600|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587601|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587602|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587603|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587604|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587605|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587606|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587607|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587608|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587609|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587610|NCT00952289|E2|Reported Event|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
587611|NCT00952289|E1|Reported Event|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
587612|NCT00952341|B3|Baseline|Total|Total of all reporting groups
587614|NCT00952341|B1|Baseline|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
587615|NCT00952341|P2|Participant Flow|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin"
587616|NCT00952341|P1|Participant Flow|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
587617|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin"
587618|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
587619|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin"
587620|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
587621|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin"
587647|NCT00952367|E1|Reported Event|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
599891|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
587622|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
587623|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin"
587624|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
587625|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin"
587626|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
587627|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin"
587628|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
587629|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin"
587630|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
587631|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin"
587632|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
587633|NCT00952341|E2|Reported Event|Placebo, Cycle 1 & Cycle 2|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin"
587822|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587634|NCT00952341|E1|Reported Event|Aprepitant (MK-0869), Cycle 1 & Cycle 2|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
587635|NCT00952367|B1|Baseline|Per-protocol Population|In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population. These participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
587636|NCT00952367|P1|Participant Flow|All Enrolled Participants|Enrolled participants signed the informed consent form, satisfied all screening criteria, and were eligible to enter the study.
587637|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
587638|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
587639|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
587640|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
587641|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
587642|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
587643|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
587644|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
587645|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
587646|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
589299|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
587648|NCT00958568|B1|Baseline|OFC (SPII-Wk 0-8, Acute Open-label)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
587649|NCT00958568|P4|Participant Flow|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587650|NCT00958568|P3|Participant Flow|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
587651|NCT00958568|P2|Participant Flow|OFC (SPIII)|6 mg Olanzapine and 25 mg Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
587652|NCT00958568|P1|Participant Flow|OFC (SPII )|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
587653|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587654|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
587655|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587656|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587657|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587658|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587659|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587660|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587661|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587662|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587663|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587823|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587664|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587665|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587666|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587667|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587668|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587669|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587670|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587671|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587672|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587673|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587674|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587675|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587676|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587677|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
589300|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
587678|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587679|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587680|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587681|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587682|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587683|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587684|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587685|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587686|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587687|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587688|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587689|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587690|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587691|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587692|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587693|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587724|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587694|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587695|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587696|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587697|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587698|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587699|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587700|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587701|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587702|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587703|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587704|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587705|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587706|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587707|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587708|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587709|NCT00958568|O1|Outcome|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
587710|NCT00958568|O1|Outcome|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
587711|NCT00958568|O1|Outcome|OFC (SPII-Wk 0-8, Acute Open-label)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
587712|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587713|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587714|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587715|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587716|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587717|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587718|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587719|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587720|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587721|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587722|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587723|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
589349|NCT00966238|P3|Participant Flow|2.0 µg i.m.|
587725|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587726|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587727|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587728|NCT00958568|E4|Reported Event|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
587729|NCT00958568|E3|Reported Event|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
587730|NCT00958568|E2|Reported Event|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
587731|NCT00958568|E1|Reported Event|OFC (SPII)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
587732|NCT00958776|B3|Baseline|Total|Total of all reporting groups
587733|NCT00958776|B2|Baseline|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587734|NCT00958776|B1|Baseline|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587735|NCT00958776|P2|Participant Flow|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587736|NCT00958776|P1|Participant Flow|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587796|NCT00958880|B1|Baseline|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
589301|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
587737|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587738|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587739|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587740|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587741|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587742|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587743|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587744|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587745|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587746|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587747|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587748|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587749|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587750|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587751|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587752|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587753|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587754|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587755|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587756|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587757|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587758|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587797|NCT00958880|P2|Participant Flow|Yohimbine Hydrochloride|Participants received Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy. Participants received Yohimbine HCL augmented Group Cognitive Behavioral Therapy. The 10.8 mg pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
587759|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587760|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587761|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587762|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587763|NCT00958776|E2|Reported Event|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
587764|NCT00958776|E1|Reported Event|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
587765|NCT00958789|B1|Baseline|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
587766|NCT00958789|P1|Participant Flow|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
587767|NCT00958789|O1|Outcome|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
587768|NCT00958789|E1|Reported Event|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
587769|NCT00958828|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
587770|NCT00958828|P2|Participant Flow|Narafilcon A / Nelfilcon A|Narafilcon A contact lenses, then Nelfilcon A contact lenses
587771|NCT00958828|P1|Participant Flow|Nelfilcon A / Narafilcon A|Nelfilcon A contact lenses, then Narafilcon A contact lenses
587772|NCT00958828|O2|Outcome|Narafilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
587773|NCT00958828|O1|Outcome|Nelfilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
587774|NCT00958828|E2|Reported Event|Narafilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
587775|NCT00958828|E1|Reported Event|Nelfilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
587776|NCT00958841|B1|Baseline|Pasireotide LAR 60mg|All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.
587777|NCT00958841|P1|Participant Flow|Pasireotide LAR 60mg|All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.
587778|NCT00958841|O1|Outcome|Nelson's Syndrome|Nelson’s syndrome is associated with local tumor extension or invasion following a therapeutic bilateral adrenalectomy
587779|NCT00958841|O1|Outcome|All PiNETS (Prolactinoma)|One of the 10 types of PiNETs analyzed
587780|NCT00958841|O1|Outcome|All PNETS (Gastrinoma)|One of the 10 types of PNETs analyzed
587781|NCT00958841|O3|Outcome|Nelson’s Syndrome|based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
587782|NCT00958841|O2|Outcome|Prolactinoma|One of the 10 types of PNETs analyzed.
587783|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
587784|NCT00958841|O3|Outcome|Nelson’s Syndrome|based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
587785|NCT00958841|O2|Outcome|Prolactinoma|One of the 10 types of PNETs analyzed.
587786|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
587787|NCT00958841|O3|Outcome|Glucagonoma|One of the 10 types of PNETs analyzed.
587788|NCT00958841|O2|Outcome|VIpoma|One of the 10 types of PNETs analyzed.
587789|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
587790|NCT00958841|E4|Reported Event|Nelsons Syndrome|Nelson's syndrome is based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48.
587791|NCT00958841|E3|Reported Event|Ectopic ACTH-secrting Tumors (EAS)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
587792|NCT00958841|E2|Reported Event|Pituitary NETs (PiNETs)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
587793|NCT00958841|E1|Reported Event|Pancreatic NETs (PNETs)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
587794|NCT00958880|B3|Baseline|Total|Total of all reporting groups
587795|NCT00958880|B2|Baseline|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
587798|NCT00958880|P1|Participant Flow|Sugar Pill|Participants received placebo (sugar pill) augmented Group Cognitive Behavioral Therapy. The pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
587799|NCT00958880|O2|Outcome|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
587800|NCT00958880|O1|Outcome|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
587801|NCT00958880|O2|Outcome|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
587802|NCT00958880|O1|Outcome|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
587803|NCT00958880|E2|Reported Event|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
587804|NCT00958880|E1|Reported Event|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
587805|NCT00958893|B1|Baseline|25 mg Proellex|25 mg Proellex daily
587806|NCT00958893|P1|Participant Flow|25 mg Proellex|25 mg Proellex: one 25 mg capsules
587807|NCT00958893|O1|Outcome|25 mg Proellex|25 mg Proellex: one 25 mg capsules
587808|NCT00958893|E1|Reported Event|25 mg Proellex|25 mg Proellex: one 25 mg capsules
587809|NCT00962741|B1|Baseline|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587810|NCT00962741|P1|Participant Flow|Etanercept|Etanercept was administered 0.8 milligram/kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587811|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587812|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587813|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587814|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587815|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587816|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587817|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587818|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587819|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587820|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587821|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
588323|NCT00963560|E1|Reported Event|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
587824|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587825|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587826|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587827|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587828|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587829|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587830|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587831|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587832|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587833|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587834|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587835|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587836|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587837|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587838|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587839|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587840|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587841|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587842|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587843|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587844|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587845|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587846|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587847|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587848|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587849|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587850|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587851|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587852|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587853|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587854|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587855|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587856|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587857|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587858|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587859|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587860|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587861|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587862|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587863|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587864|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587865|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587866|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587867|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587868|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587869|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587870|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587871|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587872|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587873|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587874|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587875|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587876|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587877|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587878|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587879|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587880|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587881|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587882|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587883|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587884|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587885|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587886|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587887|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587888|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587889|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587890|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587891|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587892|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587893|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587894|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587895|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587896|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587897|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587898|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587899|NCT00962741|E1|Reported Event|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
587900|NCT00962754|B3|Baseline|Total|Total of all reporting groups
587901|NCT00962754|B2|Baseline|Physician no Insight Fluid Balance Chart|physician does not have insight in the fluid balance data (fluid balance chart is blinded)
587902|NCT00962754|B1|Baseline|Physician Insight Fluid Balance|physician has insight in the fluid balance data
587903|NCT00962754|P2|Participant Flow|Physician no Insight Fluid Balance Chart|physician does not have insight in the fluid balance chart
587904|NCT00962754|P1|Participant Flow|Physician Insight Fluid Balance|Physician has insight in the fluid balance chart
587905|NCT00962754|O2|Outcome|Physician no Insight Fluid Balance Chart|physician has no insight in the fluid balance data (masked)
587906|NCT00962754|O1|Outcome|Physician Insight Fluid Balance|Physician has insight (full access to) in the fluid balance chart data
587907|NCT00962754|O2|Outcome|Control Group (Insight in Fluid Balance)|Physician has insight in (full access to) the fluid balance chart data
587908|NCT00962754|O1|Outcome|Intervention Group (no Insight in Fluid Balance)|physician has no insight in the fluid balance chart data (masked)
587909|NCT00962754|O2|Outcome|Control Group (Insight in Fluid Balance)|physician has insight in (full access to) the fluid balance chart data
587910|NCT00962754|O1|Outcome|Intervention Group (no Insight in Fluid Balance)|physician has no insight in fluid balance chart, ie the fluid balance chart is masked
587911|NCT00962754|E2|Reported Event|Physician no Insight Fluid Balance Chart|Physician has no insight in the fluid balance chart data (masked)
587912|NCT00962754|E1|Reported Event|Physician Insight Fluid Balance|physician has insight in (full access to) the fluid balance chart data
587913|NCT00962780|B3|Baseline|Total|Total of all reporting groups
587914|NCT00962780|B2|Baseline|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587915|NCT00962780|B1|Baseline|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587916|NCT00962780|P2|Participant Flow|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587917|NCT00962780|P1|Participant Flow|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587918|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587919|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587920|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587921|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587922|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587923|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587995|NCT00962871|E4|Reported Event|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
587924|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587925|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587926|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587927|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587928|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587929|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587930|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587931|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587932|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587933|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587934|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587935|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
588065|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
587936|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587937|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587938|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587939|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587940|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587941|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587942|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587943|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587944|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587945|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
588040|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
587946|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587947|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587948|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587949|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587950|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587951|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587952|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587953|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587954|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587955|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587956|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587957|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587958|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587959|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587960|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587961|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587962|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587963|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587964|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587965|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587966|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587967|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587968|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587969|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587970|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587971|NCT00962780|O1|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
587972|NCT00962780|E6|Reported Event|Follow-up|Participants >=6 years of age (all participants) who received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed from 23vPS blood draw to the 6-month follow-up telephone contact after 13vPnC Dose 3.
587973|NCT00962780|E5|Reported Event|23vPS Dose|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between 23vPS Dose and before 23vPS Dose blood draw 1 month after 23vPS Dose.
587974|NCT00962780|E4|Reported Event|13vPnC Dose 3|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 2 (13vPnC Dose 3), assessed between 13vPnC Dose 3 and before 23vPS Dose.
587975|NCT00962780|E3|Reported Event|13vPnC Dose 2|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 1 (13vPnC Dose 2), assessed between 13vPnC Dose 2 and before 13vPnC Dose 3.
587976|NCT00962780|E2|Reported Event|13vPnC Dose 1|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose 2.
587977|NCT00962780|E1|Reported Event|Prior 13vPnC Dose 1|Participants >=6 years of age (all participants) who received at least 1 of 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between signing of informed consent form and before 13vPnC Dose 1.
587978|NCT00962871|B5|Baseline|Total|Total of all reporting groups
587979|NCT00962871|B4|Baseline|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
587980|NCT00962871|B3|Baseline|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587981|NCT00962871|B2|Baseline|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587982|NCT00962871|B1|Baseline|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587983|NCT00962871|P4|Participant Flow|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
587984|NCT00962871|P3|Participant Flow|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587985|NCT00962871|P2|Participant Flow|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587986|NCT00962871|P1|Participant Flow|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587987|NCT00962871|O4|Outcome|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
587988|NCT00962871|O3|Outcome|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587989|NCT00962871|O2|Outcome|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587990|NCT00962871|O1|Outcome|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587991|NCT00962871|O4|Outcome|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
587992|NCT00962871|O3|Outcome|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587993|NCT00962871|O2|Outcome|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587994|NCT00962871|O1|Outcome|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587996|NCT00962871|E3|Reported Event|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587997|NCT00962871|E2|Reported Event|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587998|NCT00962871|E1|Reported Event|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
587999|NCT00963157|B6|Baseline|Total|Total of all reporting groups
588000|NCT00963157|B5|Baseline|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588001|NCT00963157|B4|Baseline|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588002|NCT00963157|B3|Baseline|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588003|NCT00963157|B2|Baseline|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588004|NCT00963157|B1|Baseline|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588005|NCT00963157|P5|Participant Flow|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588006|NCT00963157|P4|Participant Flow|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588007|NCT00963157|P3|Participant Flow|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588008|NCT00963157|P2|Participant Flow|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588009|NCT00963157|P1|Participant Flow|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588010|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588011|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588012|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588013|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588014|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588015|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588016|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588017|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588018|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588019|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588020|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588021|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588022|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588023|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588024|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588025|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588026|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588027|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588028|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588029|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588030|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588031|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588032|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588033|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588034|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588035|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588036|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588037|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588038|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588039|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588041|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588042|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588043|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588044|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588045|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588046|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588047|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588048|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588049|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588050|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588051|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588052|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588053|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588054|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588055|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588056|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588057|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588058|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588059|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588060|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588061|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588062|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588063|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588064|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588066|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588067|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588068|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588069|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588070|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588071|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588072|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588073|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588074|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588075|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588076|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588077|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588078|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588079|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588080|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588081|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588082|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588083|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588084|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588085|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588086|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588298|NCT00963482|E2|Reported Event|Control Group|Autogenic training
588087|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588088|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588089|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588090|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588091|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588092|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588093|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588094|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588095|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588096|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588097|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588098|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588099|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588100|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588101|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588102|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588103|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588104|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588105|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588106|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588107|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588108|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588109|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588110|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588111|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588112|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588113|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588114|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588115|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588116|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588117|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588118|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588119|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588120|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588121|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588122|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588123|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588124|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588125|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588126|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588127|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588128|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588129|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588130|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588131|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588132|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
599892|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
588133|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588134|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588135|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588136|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588137|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588138|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588139|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588140|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588141|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588142|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588143|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588144|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588145|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588146|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588147|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588148|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588149|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588150|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588151|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588152|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588153|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588154|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588155|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588156|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588157|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588158|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588159|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588160|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588161|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588162|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588163|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588164|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588165|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588166|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588167|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588168|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588169|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588170|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588171|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588172|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588173|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588174|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588175|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588176|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588177|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588178|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
599893|NCT00995345|O1|Outcome|Placebo|Tablet
588179|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588180|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588181|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588182|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588183|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588184|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588185|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588186|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588187|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588188|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588189|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588190|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588191|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588192|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588193|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588194|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588195|NCT00963157|E5|Reported Event|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588196|NCT00963157|E4|Reported Event|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588197|NCT00963157|E3|Reported Event|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
588198|NCT00963157|E2|Reported Event|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588199|NCT00963157|E1|Reported Event|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
588200|NCT00963235|B1|Baseline|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588201|NCT00963235|P1|Participant Flow|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588202|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588203|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588204|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588205|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588206|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588207|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588208|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588209|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588210|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588211|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588212|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588213|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588299|NCT00963482|E1|Reported Event|Intervention Group|Cognitive-behavioural smoking cessation program
588214|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
588215|NCT00963235|E4|Reported Event|13vPnC (After Dose 3 Blood Draw)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received at least 1 of the 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from the blood draw 28 to 42 days post-13vPnC Dose 3 up to 6-month follow-up.
588216|NCT00963235|E3|Reported Event|13vPnC (After Dose 3 and Before Dose 3 Blood Draw)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 3 to prior to the blood draw 28 to 42 days post-13vPnC Dose 3.
588217|NCT00963235|E2|Reported Event|13vPnC (After Dose 2 and Before Dose 3)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 2 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 2 prior to administration of 13vPnC Dose 3.
588218|NCT00963235|E1|Reported Event|13vPnC (After Dose 1 and Before Dose 2)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 1 dose of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and were assessed from 13vPnC Dose 1 to prior to administration of 13vPnC Dose 2.
588219|NCT00963430|B3|Baseline|Total|Total of all reporting groups
588220|NCT00963430|B2|Baseline|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588221|NCT00963430|B1|Baseline|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588222|NCT00963430|P2|Participant Flow|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588223|NCT00963430|P1|Participant Flow|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588224|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588225|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588226|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588227|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588228|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588229|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588230|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588324|NCT00963599|B5|Baseline|Total|Total of all reporting groups
588231|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588232|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588233|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588234|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588235|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588236|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588237|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588238|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588239|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588240|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588241|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588242|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588243|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588244|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588245|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588246|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588247|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588248|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588249|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588250|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588251|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588300|NCT00963508|B3|Baseline|Total|Total of all reporting groups
588252|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588253|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588254|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588255|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588256|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588257|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588258|NCT00963430|E2|Reported Event|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588259|NCT00963430|E1|Reported Event|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
588260|NCT00963469|B4|Baseline|Total|Total of all reporting groups
588261|NCT00963469|B3|Baseline|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
588262|NCT00963469|B2|Baseline|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588263|NCT00963469|B1|Baseline|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588264|NCT00963469|P3|Participant Flow|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
588265|NCT00963469|P2|Participant Flow|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588266|NCT00963469|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588267|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
588268|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588269|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588270|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
588271|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588272|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588273|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
588274|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588275|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588276|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
588277|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588278|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588279|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
588280|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588281|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588282|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
588283|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588284|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588285|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
588286|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588287|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588288|NCT00963469|E3|Reported Event|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
588289|NCT00963469|E2|Reported Event|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588290|NCT00963469|E1|Reported Event|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
588291|NCT00963482|B3|Baseline|Total|Total of all reporting groups
588292|NCT00963482|B2|Baseline|Control Group|Autogenic training
588293|NCT00963482|B1|Baseline|Intervention Group|Cognitive-behavioural smoking cessation program
588294|NCT00963482|P2|Participant Flow|Control Group|Autogenic training
588295|NCT00963482|P1|Participant Flow|Intervention Group|Cognitive-behavioural smoking cessation program
588296|NCT00963482|O2|Outcome|Control Group|Autogenic training
588297|NCT00963482|O1|Outcome|Intervention Group|Cognitive-behavioural smoking cessation program
588301|NCT00963508|B2|Baseline|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes
Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
588302|NCT00963508|B1|Baseline|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
588303|NCT00963508|P2|Participant Flow|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes
Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
588304|NCT00963508|P1|Participant Flow|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
588305|NCT00963508|O2|Outcome|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes
Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
588306|NCT00963508|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
588307|NCT00963508|O2|Outcome|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes
Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
588308|NCT00963508|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
588309|NCT00963508|E2|Reported Event|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes
Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
588310|NCT00963508|E1|Reported Event|Malathion Gel|"Malathion gel 0.5% 30 minute application
Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
588311|NCT00963560|B4|Baseline|Total|Total of all reporting groups
588312|NCT00963560|B3|Baseline|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
588313|NCT00963560|B2|Baseline|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
588314|NCT00963560|B1|Baseline|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
588315|NCT00963560|P3|Participant Flow|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
588316|NCT00963560|P2|Participant Flow|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
588317|NCT00963560|P1|Participant Flow|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
588318|NCT00963560|O3|Outcome|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
588319|NCT00963560|O2|Outcome|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
588320|NCT00963560|O1|Outcome|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
588321|NCT00963560|E3|Reported Event|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
588322|NCT00963560|E2|Reported Event|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
588325|NCT00963599|B4|Baseline|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588326|NCT00963599|B3|Baseline|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588327|NCT00963599|B2|Baseline|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588328|NCT00963599|B1|Baseline|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588329|NCT00963599|P4|Participant Flow|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588330|NCT00963599|P3|Participant Flow|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588331|NCT00963599|P2|Participant Flow|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588332|NCT00963599|P1|Participant Flow|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588333|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588334|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588335|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588336|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588337|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588338|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588339|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588340|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588341|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588342|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588343|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588344|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588345|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588346|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588347|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588348|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588349|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588350|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588351|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588352|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588353|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588354|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588355|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588356|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588357|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588358|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588359|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588360|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588361|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588362|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588363|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588364|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588365|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588366|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588367|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588368|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588369|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588370|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588371|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588372|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588373|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
589302|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
588374|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588375|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588376|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588377|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588378|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588379|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588380|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588381|NCT00963599|E4|Reported Event|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
588382|NCT00963599|E3|Reported Event|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588383|NCT00963599|E2|Reported Event|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588384|NCT00963599|E1|Reported Event|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
588385|NCT00963638|B3|Baseline|Total|Total of all reporting groups
588386|NCT00963638|B2|Baseline|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
588387|NCT00963638|B1|Baseline|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
588388|NCT00963638|P2|Participant Flow|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
588389|NCT00963638|P1|Participant Flow|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
588390|NCT00963638|O2|Outcome|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
588391|NCT00963638|O1|Outcome|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
588392|NCT00963638|E2|Reported Event|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
588393|NCT00963638|E1|Reported Event|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
588394|NCT00963677|B3|Baseline|Total|Total of all reporting groups
588395|NCT00963677|B2|Baseline|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
588576|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588396|NCT00963677|B1|Baseline|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
588397|NCT00963677|P2|Participant Flow|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
588398|NCT00963677|P1|Participant Flow|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
588399|NCT00963677|O2|Outcome|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
588400|NCT00963677|O1|Outcome|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
588401|NCT00963677|O2|Outcome|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
588402|NCT00963677|O1|Outcome|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
588403|NCT00963677|E2|Reported Event|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
588404|NCT00963677|E1|Reported Event|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
588405|NCT00963807|B1|Baseline|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery"
589217|NCT00955955|O6|Outcome|Pooled Placebo|Patients in this group received placebo at some point during the study. Results are pooled from phase I and II.
588406|NCT00963807|P1|Participant Flow|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery"
588407|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery"
588408|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery"
588409|NCT00963807|O2|Outcome|Non-Responders|RECIST non-responders based on CT measurements performed after 2 cycles of neoadjuvant therapy
588410|NCT00963807|O1|Outcome|Responders|RECIST responders based on CT measurements performed after 2 cycles of neoadjuvant therapy.
588411|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery"
588432|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588577|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
589350|NCT00966238|P2|Participant Flow|1.0 µg i.m.|
588412|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery"
588413|NCT00963807|E1|Reported Event|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
Cisplatin: Given IV
Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT
Dexamethasone: Given PO
Docetaxel: Given IV
Fludeoxyglucose F-18: Undergo FDG PET/CT
Fluorothymidine F-18: Undergo FLT PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT
Therapeutic Conventional Surgery: Undergo surgery"
588414|NCT00963820|B1|Baseline|Overall Study|Safety Population
588415|NCT00963820|P12|Participant Flow|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588416|NCT00963820|P11|Participant Flow|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588417|NCT00963820|P10|Participant Flow|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588418|NCT00963820|P9|Participant Flow|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established Maximum Tolerated Dose (MTD), capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588419|NCT00963820|P8|Participant Flow|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588420|NCT00963820|P7|Participant Flow|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588421|NCT00963820|P6|Participant Flow|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588422|NCT00963820|P5|Participant Flow|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588423|NCT00963820|P4|Participant Flow|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588424|NCT00963820|P3|Participant Flow|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588425|NCT00963820|P2|Participant Flow|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588426|NCT00963820|P1|Participant Flow|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588427|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588428|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588429|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588430|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588431|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588433|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588434|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588435|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588436|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588437|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588438|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588439|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588440|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588441|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588442|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588443|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588595|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588444|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588445|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588446|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588447|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588448|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588449|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588450|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588451|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588452|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588453|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588454|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
589351|NCT00966238|P1|Participant Flow|0.5 µg i.m.|
588455|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588456|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588457|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588458|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588459|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588460|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588461|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588462|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588463|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588464|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588465|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588466|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588467|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588468|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588469|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588470|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588471|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588472|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588473|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588474|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588475|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588476|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588477|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
589149|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
588478|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588479|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588480|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588481|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588482|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588483|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588484|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588485|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588486|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588487|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588488|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588489|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
589303|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
588490|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588491|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588492|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588493|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588494|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588495|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588496|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588497|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588498|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588499|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588500|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588501|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588502|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588503|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588504|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588505|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588506|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588507|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588508|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588509|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588510|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588511|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588512|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
589304|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
588513|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588514|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588515|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588516|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588517|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588518|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588519|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588520|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588521|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588522|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588546|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588523|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588524|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588525|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588526|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588527|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588528|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588529|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588530|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588531|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588532|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588533|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588534|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588535|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588536|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588537|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588538|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588539|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588540|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588541|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588542|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588543|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588544|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588545|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588547|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588548|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588549|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588550|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588551|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588552|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588553|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588554|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588555|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588556|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588557|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588558|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
589305|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
588559|NCT00963820|E2|Reported Event|Expansion Cohorts|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Expansion Period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588560|NCT00963820|E1|Reported Event|Dose Escalation Cohorts|Ixazomib citrate, 0.24 to 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Dose Escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
588561|NCT00963859|B1|Baseline|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
588562|NCT00963859|P1|Participant Flow|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
588563|NCT00963859|O1|Outcome|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
588564|NCT00963859|O1|Outcome|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
588565|NCT00963859|E1|Reported Event|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
588566|NCT00963872|B3|Baseline|Total|Total of all reporting groups
588567|NCT00963872|B2|Baseline|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588568|NCT00963872|B1|Baseline|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588569|NCT00963872|P2|Participant Flow|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588570|NCT00963872|P1|Participant Flow|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588571|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588572|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588573|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588574|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588575|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
589150|NCT00955617|E2|Reported Event|Gadovist MRA|Patients who received a Gadovist enhanced-MRA
588578|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588579|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588580|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588581|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588582|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588583|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588584|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588585|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588586|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588587|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588588|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588589|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588590|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588591|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588592|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588593|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588594|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
589221|NCT00955955|O2|Outcome|Adjunct Placebo Phase 1|Participants will receive placebo for the first 4 weeks
588596|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588597|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588598|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588599|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588600|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588601|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588602|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588603|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588604|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588605|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588606|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588607|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588608|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588609|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588610|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588611|NCT00963872|E2|Reported Event|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
588612|NCT00963872|E1|Reported Event|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
588613|NCT00963924|B3|Baseline|Total|Total of all reporting groups
589352|NCT00966238|O6|Outcome|8.0 µg i.m.|
588614|NCT00963924|B2|Baseline|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
588615|NCT00963924|B1|Baseline|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
588616|NCT00963924|P2|Participant Flow|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
588617|NCT00963924|P1|Participant Flow|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
588618|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588619|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588620|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588621|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588622|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588623|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588624|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588652|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588625|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588626|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588627|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588628|NCT00963924|O2|Outcome|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
588629|NCT00963924|O1|Outcome|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
588630|NCT00963924|E2|Reported Event|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588631|NCT00963924|E1|Reported Event|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
588632|NCT00963937|B4|Baseline|Total|Total of all reporting groups
588633|NCT00963937|B3|Baseline|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588634|NCT00963937|B2|Baseline|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588635|NCT00963937|B1|Baseline|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
588636|NCT00963937|P3|Participant Flow|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588833|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
588637|NCT00963937|P2|Participant Flow|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588638|NCT00963937|P1|Participant Flow|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
588639|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
588640|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588641|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588642|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
588643|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
588644|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588645|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588646|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
588647|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
588648|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588649|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588650|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
588651|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
588653|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588654|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
588655|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
588656|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588657|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588658|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
588659|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
588660|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588661|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588662|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
588663|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
588664|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588665|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588826|NCT00964496|E1|Reported Event|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588666|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
588667|NCT00963937|O2|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
588668|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
588669|NCT00963937|E4|Reported Event|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
588670|NCT00963937|E3|Reported Event|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588671|NCT00963937|E2|Reported Event|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
588672|NCT00963937|E1|Reported Event|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
588673|NCT00964028|B3|Baseline|Total|Total of all reporting groups
588674|NCT00964028|B2|Baseline|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
588675|NCT00964028|B1|Baseline|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
588676|NCT00964028|P2|Participant Flow|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
588677|NCT00964028|P1|Participant Flow|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
588678|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
588679|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
589306|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
588680|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
588681|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
588682|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
588683|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
588684|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
588685|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
588686|NCT00964028|E2|Reported Event|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
588687|NCT00964028|E1|Reported Event|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
588688|NCT00964119|B1|Baseline|Single Cohort Observational|
588689|NCT00964119|P1|Participant Flow|Single Cohort Obervational|
588690|NCT00964119|O1|Outcome|Single Cohort Observational|
588691|NCT00964119|E1|Reported Event|Single Cohort Observational|
588827|NCT00964548|B3|Baseline|Total|Total of all reporting groups
588828|NCT00964548|B2|Baseline|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
589151|NCT00955617|E1|Reported Event|Dotarem MRA|Patients who received a Dotarem enhanced-MRA
588692|NCT00964223|B1|Baseline|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588693|NCT00964223|P1|Participant Flow|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588694|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588695|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588696|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588697|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588698|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588699|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588700|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588701|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588814|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
589307|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
588702|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588703|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588704|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588705|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588706|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588707|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588708|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588829|NCT00964548|B1|Baseline|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
588709|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588710|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588711|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588712|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588713|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588714|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588715|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588716|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588717|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588718|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588719|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
599908|NCT00995345|E1|Reported Event|Placebo|Tablet
588720|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588721|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588722|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588723|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588724|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588725|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588726|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588727|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588728|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588729|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588730|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588731|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588732|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588733|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588734|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588735|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588736|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588737|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
589308|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
588738|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588739|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588740|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588741|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588742|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588743|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588744|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588745|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588746|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588747|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588748|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588749|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588750|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588751|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588752|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588753|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588754|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588755|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
589309|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
588756|NCT00964223|E1|Reported Event|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
588757|NCT00964366|B3|Baseline|Total|Total of all reporting groups
588758|NCT00964366|B2|Baseline|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588759|NCT00964366|B1|Baseline|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588760|NCT00964366|P2|Participant Flow|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588761|NCT00964366|P1|Participant Flow|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588762|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588830|NCT00964548|P2|Participant Flow|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
588831|NCT00964548|P1|Participant Flow|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
588763|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588764|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588765|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588766|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588767|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588768|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588769|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588770|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588771|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588772|NCT00964366|E2|Reported Event|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588773|NCT00964366|E1|Reported Event|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
588774|NCT00964392|B3|Baseline|Total|Total of all reporting groups
588775|NCT00964392|B2|Baseline|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
588776|NCT00964392|B1|Baseline|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
588777|NCT00964392|P2|Participant Flow|Less-Experienced Physicians (LEP)|LEP are defined as those who have performed less than or equal to 50 AF ablations per year.
588778|NCT00964392|P1|Participant Flow|More-Experienced Physicians (MEP)|MEP are defined as those who have performed greater than 50 AF ablation cases per year.
588779|NCT00964392|O2|Outcome|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
588780|NCT00964392|O1|Outcome|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
588781|NCT00964392|O2|Outcome|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
588782|NCT00964392|O1|Outcome|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
588783|NCT00964392|E2|Reported Event|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
588832|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
588784|NCT00964392|E1|Reported Event|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
588785|NCT00964431|B5|Baseline|Total|Total of all reporting groups
588786|NCT00964431|B4|Baseline|Placebo|
588787|NCT00964431|B3|Baseline|Celecoxib 400 mg|
588788|NCT00964431|B2|Baseline|Indomethacin Test (Upper Dose)|Single dose
588789|NCT00964431|B1|Baseline|Indomethacin Test (Lower Dose)|
588790|NCT00964431|P4|Participant Flow|Placebo|
588791|NCT00964431|P3|Participant Flow|Celecoxib 400 mg|
588792|NCT00964431|P2|Participant Flow|Indomethacin Test (Upper Dose)|Single dose
588793|NCT00964431|P1|Participant Flow|Indomethacin Test (Lower Dose)|
588794|NCT00964431|O4|Outcome|Placebo|
588795|NCT00964431|O3|Outcome|Celecoxib 400 mg|
588796|NCT00964431|O2|Outcome|Indomethacin Test (Upper Dose)|40-mg
588797|NCT00964431|O1|Outcome|Indomethacin Test (Lower Dose)|20-mg
588798|NCT00964431|E4|Reported Event|Placebo|
588799|NCT00964431|E3|Reported Event|Celecoxib 400 mg|
588800|NCT00964431|E2|Reported Event|Indomethacin Test (Upper Dose)|Single dose
588801|NCT00964431|E1|Reported Event|Indomethacin Test (Lower Dose)|
588802|NCT00964444|B1|Baseline|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
588803|NCT00964444|P1|Participant Flow|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
588804|NCT00964444|O1|Outcome|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
588805|NCT00964444|E1|Reported Event|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
588806|NCT00964496|B3|Baseline|Total|Total of all reporting groups
588807|NCT00964496|B2|Baseline|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588808|NCT00964496|B1|Baseline|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588809|NCT00964496|P2|Participant Flow|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588810|NCT00964496|P1|Participant Flow|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588811|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588812|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588813|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
589222|NCT00955955|O1|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase 1|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 4 weeks.
588815|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588816|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588817|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588818|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588819|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588820|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588821|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588822|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588823|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588824|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588825|NCT00964496|E2|Reported Event|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
588834|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
588835|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
588836|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
588837|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
588838|NCT00964548|E2|Reported Event|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
588839|NCT00964548|E1|Reported Event|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
588840|NCT00964678|B1|Baseline|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
Carvedilol: twice daily oral treatment in escalating dose"
588841|NCT00964678|P1|Participant Flow|Carvedilol|Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
588842|NCT00964678|O1|Outcome|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
Carvedilol: twice daily oral treatment in escalating dose"
588843|NCT00964678|O1|Outcome|Carvedilol|Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
588844|NCT00964678|O1|Outcome|Carvedilol|Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
588845|NCT00964678|O1|Outcome|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
Carvedilol: twice daily oral treatment in escalating dose"
588846|NCT00964678|E1|Reported Event|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
Carvedilol: twice daily oral treatment in escalating dose"
588847|NCT00964743|B1|Baseline|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
588848|NCT00964743|P1|Participant Flow|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
588952|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
588849|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
588850|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
588851|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
588852|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
588853|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
588854|NCT00964743|E1|Reported Event|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
588855|NCT00964795|B1|Baseline|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
588856|NCT00964795|P1|Participant Flow|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
588857|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
588858|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
588859|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
588860|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
588953|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
589310|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
588861|NCT00964795|E1|Reported Event|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting from amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
588862|NCT00964860|B3|Baseline|Total|Total of all reporting groups
588863|NCT00964860|B2|Baseline|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
588864|NCT00964860|B1|Baseline|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
588865|NCT00964860|P2|Participant Flow|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
588866|NCT00964860|P1|Participant Flow|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
588867|NCT00964860|O2|Outcome|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
588868|NCT00964860|O1|Outcome|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
588869|NCT00964860|O2|Outcome|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
588870|NCT00964860|O1|Outcome|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
588871|NCT00964860|E2|Reported Event|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
588872|NCT00964860|E1|Reported Event|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
588873|NCT00964886|B5|Baseline|Total|Total of all reporting groups
588874|NCT00964886|B4|Baseline|Arm 4|"anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
588875|NCT00964886|B3|Baseline|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
589152|NCT00955721|B3|Baseline|Total|Total of all reporting groups
588876|NCT00964886|B2|Baseline|Arm 2|"cognitive behavioral therapy
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
588877|NCT00964886|B1|Baseline|Arm 1|"desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
588878|NCT00964886|P4|Participant Flow|Arm 4|"anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
588879|NCT00964886|P3|Participant Flow|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
588880|NCT00964886|P2|Participant Flow|Arm 2|"cognitive behavioral therapy
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
588881|NCT00964886|P1|Participant Flow|Arm 1|"desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
588882|NCT00964886|O2|Outcome|Arm 1 + Arm 4|Factor all participants assigned at baseline not to receive cognitive behavioral therapy
588883|NCT00964886|O1|Outcome|Arm 2 + Arm 3|Factor all participants assigned at baseline to receive cognitive behavioral therapy
588884|NCT00964886|O2|Outcome|Arm 1 + Arm 4|Factor no cognitive behavioral therapy
588885|NCT00964886|O1|Outcome|Arm 2 + Arm 3|"Factor cognitive behavioral therapy
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
588886|NCT00964886|O2|Outcome|Arm 2 + Arm 4|Factor all participants assigned at baseline to receive benztropine mesylate (active placebo)
588887|NCT00964886|O1|Outcome|Arm 1 + Arm 3|Factor all participants assigned at baseline to receive desipramine hydrochloride
588888|NCT00964886|O2|Outcome|Arm 2 + Arm 4|"Factor anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
588889|NCT00964886|O1|Outcome|Arm 1 + Arm 3|"Factor desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
588890|NCT00964886|E4|Reported Event|Arm 4|"anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
588891|NCT00964886|E3|Reported Event|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
588892|NCT00964886|E2|Reported Event|Arm 2|"cognitive behavioral therapy
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
588893|NCT00964886|E1|Reported Event|Arm 1|"desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
588894|NCT00965081|B3|Baseline|Total|Total of all reporting groups
588895|NCT00965081|B2|Baseline|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588896|NCT00965081|B1|Baseline|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588897|NCT00965081|P2|Participant Flow|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588898|NCT00965081|P1|Participant Flow|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588899|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588900|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588901|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588902|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588903|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
589000|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg
Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
589001|NCT00955266|O2|Outcome|Placebo|"Normal saline
Placebo: Normal saline, 50cc delivered over 5 minutes"
588904|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588905|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588906|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588907|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588908|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588909|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588910|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588911|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588912|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588913|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588914|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588915|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588916|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
588917|NCT00965081|E3|Reported Event|Duloxetine 60 mg|Participants who enter the study with a diagnosis of major depressive disorder (MDD) and who also meet the predefined blinded criteria for worsening of depression during the acute therapy phase will be rescued to daily duloxetine 60 mg for the remainder of the acute therapy phase.
588918|NCT00965081|E2|Reported Event|Duloxetine 30 mg|Duloxetine 30 mg dose daily by mouth at the same time each day for 12 weeks
588919|NCT00965081|E1|Reported Event|Placebo|Placebo (inactive capsules identical in appearance to duloxetine capsules) daily by mouth at the same time each day for 12 weeks.
588920|NCT00965094|B3|Baseline|Total|Total of all reporting groups
588921|NCT00965094|B2|Baseline|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
588922|NCT00965094|B1|Baseline|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
588923|NCT00965094|P2|Participant Flow|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
589002|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg
Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
589003|NCT00955266|E2|Reported Event|Placebo|"Normal saline
Placebo: Normal saline, 50cc delivered over 5 minutes"
588924|NCT00965094|P1|Participant Flow|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
588925|NCT00965094|O2|Outcome|Reference Therapy|Control Arm: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
588926|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
588927|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
588928|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
588929|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
588954|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
588955|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
588956|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
588930|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
588931|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
588932|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
588933|NCT00965094|O2|Outcome|Reference Therapy|Control Arm: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
589353|NCT00966238|O5|Outcome|5.0 µg i.m.|
588934|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
588935|NCT00965094|E2|Reported Event|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
588936|NCT00965094|E1|Reported Event|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
588937|NCT00965146|B1|Baseline|Scorpio® CR Total Knee System Study Device|All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
588938|NCT00965146|P1|Participant Flow|Scorpio® CR Device|All subjects were implanted with the Scorpio® CR Total Knee System Study Device
588939|NCT00965146|O1|Outcome|Scorpio® CR Device|All subjects received the Scorpio® CR Device
588940|NCT00965146|E1|Reported Event|Scorpio® CR Total Knee System Study Device|All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
588941|NCT00965185|B3|Baseline|Total|Total of all reporting groups
588942|NCT00965185|B2|Baseline|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
588943|NCT00965185|B1|Baseline|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
588944|NCT00965185|P2|Participant Flow|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
588945|NCT00965185|P1|Participant Flow|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
588946|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
588947|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
588948|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
588949|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
588950|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
588951|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
588957|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
588958|NCT00965185|E2|Reported Event|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
588959|NCT00965185|E1|Reported Event|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
588960|NCT00965237|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects.
588961|NCT00965237|P2|Participant Flow|Single Vision CL + Reading Glasses / Multifocal CL|Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
588962|NCT00965237|P1|Participant Flow|Multifocal CL / Single Vision CL+ Reading Glasses|Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
588963|NCT00965237|O2|Outcome|Lotrafilcon B Single Vision Contact Lens + Reading Glasses|Commercially marketed, lotrafilcon B, silicone hydrogel, single vision contact lenses for daily wear use, with over-reader spectacles worn as needed
588964|NCT00965237|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Commercially marketed, lotrafilcon B, silicone hydrogel, multifocal contact lens for daily wear use
588965|NCT00965237|E2|Reported Event|Single Vision Contact Lens|Commercially marketed lotrafilcon B single vision contact lenses
588966|NCT00965237|E1|Reported Event|Multifocal Contact Lens|Commercially marketed lotrafilcon B multifocal contact lenses
588967|NCT00965250|B3|Baseline|Total|Total of all reporting groups
588968|NCT00965250|B2|Baseline|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
589004|NCT00955266|E1|Reported Event|Calcium Choloride|"Calcium chloride, 10mg/kg
Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
588969|NCT00965250|B1|Baseline|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588970|NCT00965250|P2|Participant Flow|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588971|NCT00965250|P1|Participant Flow|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588972|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588973|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588974|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588975|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588976|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588977|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588978|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588979|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588980|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588981|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588982|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588983|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588984|NCT00965250|O1|Outcome|IMC-A12 Monotherapy in Patients|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
588985|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588986|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
588987|NCT00965250|E1|Reported Event|IMC-A12 Monotherapy in Patients|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
588988|NCT00955266|B3|Baseline|Total|Total of all reporting groups
588989|NCT00955266|B2|Baseline|Placebo|"Normal saline
Placebo: Normal saline, 50cc delivered over 5 minutes"
588990|NCT00955266|B1|Baseline|Calcium Choloride|"Calcium chloride, 10mg/kg
Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
588991|NCT00955266|P2|Participant Flow|Placebo|"Normal saline
Placebo: Normal saline, 50cc delivered over 5 minutes"
588992|NCT00955266|P1|Participant Flow|Calcium Choloride|"Calcium chloride, 10mg/kg
Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
588993|NCT00955266|O2|Outcome|Placebo|"Normal saline
Placebo: Normal saline, 50cc delivered over 5 minutes"
588994|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg
Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
588995|NCT00955266|O2|Outcome|Placebo|"Normal saline
Placebo: Normal saline, 50cc delivered over 5 minutes"
588996|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg
Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
588997|NCT00955266|O2|Outcome|Placebo|"Normal saline
Placebo: Normal saline, 50cc delivered over 5 minutes"
588998|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg
Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
588999|NCT00955266|O2|Outcome|Placebo|"Normal saline
Placebo: Normal saline, 50cc delivered over 5 minutes"
589005|NCT00955279|B4|Baseline|Total|Total of all reporting groups
589006|NCT00955279|B3|Baseline|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
589007|NCT00955279|B2|Baseline|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
589008|NCT00955279|B1|Baseline|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
589009|NCT00955279|P3|Participant Flow|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
589010|NCT00955279|P2|Participant Flow|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
589011|NCT00955279|P1|Participant Flow|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
589012|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
589013|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
589014|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
589015|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
589016|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
589017|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
589018|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
589019|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
589020|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
589021|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
589022|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
589023|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
589024|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
589223|NCT00955955|E2|Reported Event|Placebo|Adverse events for participants who received placebo during the study.
589025|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
589026|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
589027|NCT00955279|E3|Reported Event|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
589028|NCT00955279|E2|Reported Event|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
589029|NCT00955279|E1|Reported Event|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
589030|NCT00955305|B3|Baseline|Total|Total of all reporting groups
589031|NCT00955305|B2|Baseline|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
589032|NCT00955305|B1|Baseline|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
589033|NCT00955305|P2|Participant Flow|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
589034|NCT00955305|P1|Participant Flow|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
589035|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
589089|NCT00955487|B3|Baseline|Total|Total of all reporting groups
589036|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
589037|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
589038|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
589039|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
589040|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
589041|NCT00955305|E2|Reported Event|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
589042|NCT00955305|E1|Reported Event|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
589043|NCT00955357|B3|Baseline|Total|Total of all reporting groups
589044|NCT00955357|B2|Baseline|Later-Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.
Lacosamide: oral tablet
Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
589045|NCT00955357|B1|Baseline|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.
Lacosamide: oral tablet
Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
599909|NCT00995371|B3|Baseline|Total|Total of all reporting groups
589046|NCT00955357|P2|Participant Flow|Later Add-on|"Lacosamide added to 1 to 3 Anti-Epileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.
Lacosamide: oral tablet
Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
589047|NCT00955357|P1|Participant Flow|First Add-on|"Lacosamide added to first adequate monotherapy (no history of Anti-Epileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening.
Lacosamide: oral tablet
Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
589048|NCT00955357|O2|Outcome|Later Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.
Lacosamide: oral tablet
Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
589049|NCT00955357|O1|Outcome|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.
Lacosamide: oral tablet
Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
589050|NCT00955357|E2|Reported Event|Later Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.
Lacosamide: oral tablet
Subjects Titration Phase (6 Weeks):
Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks):
200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks):
50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
589051|NCT00955357|E1|Reported Event|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.
Lacosamide: oral tablet
Subjects Titration Phase (6 Weeks):
Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks):
200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks):
50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
589052|NCT00955474|B3|Baseline|Total|Total of all reporting groups
589053|NCT00955474|B2|Baseline|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589054|NCT00955474|B1|Baseline|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589055|NCT00955474|P2|Participant Flow|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589056|NCT00955474|P1|Participant Flow|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589103|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589218|NCT00955955|O5|Outcome|Pooled Deplin|Patients in this group received Deplin at some point during the study. Results are pooled from phase I and II.
589057|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589058|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589059|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589060|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589145|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
589061|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589062|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589063|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589064|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589065|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589104|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589219|NCT00955955|O4|Outcome|Adjunct Placebo Phase 2|Patients in this group received placebo in both phases of the study for a total of 8 weeks,
589066|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589067|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589068|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589069|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589070|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589071|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589072|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589073|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589074|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589084|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589220|NCT00955955|O3|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase 2|Participants will receive 15 mg of Deplin (6(S)-5-MTHF) for 4 weeks.
589075|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589076|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589077|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589078|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589079|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589080|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589081|NCT00955474|O2|Outcome|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589082|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589083|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589102|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589211|NCT00955955|P2|Participant Flow|Placebo/Deplin|Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
589085|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589086|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589087|NCT00955474|E2|Reported Event|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI
Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
589088|NCT00955474|E1|Reported Event|Quetiapine|"Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
589090|NCT00955487|B2|Baseline|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589091|NCT00955487|B1|Baseline|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589092|NCT00955487|P6|Participant Flow|1000-1250g Placebo (Nitrogen)|"Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589093|NCT00955487|P5|Participant Flow|1000-1250g Inhaled Nitric Oxide (iNO)|"Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589094|NCT00955487|P4|Participant Flow|750-999g Placebo (Nitrogen)|"Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589095|NCT00955487|P3|Participant Flow|750-999g Inhaled Nitric Oxide (iNO)|"Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589096|NCT00955487|P2|Participant Flow|500-749g Placebo (Nitrogen)|"Participants weighing between 500 and 749 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589097|NCT00955487|P1|Participant Flow|500-749g Inhaled Nitric Oxide (iNO)|"Participants weighing between 500 and 749 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589098|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589099|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589100|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589101|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589212|NCT00955955|P1|Participant Flow|Deplin/Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
600172|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
589105|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589106|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589107|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589108|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589109|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589110|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589111|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589112|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589146|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
589147|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
589148|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
589113|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589114|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589115|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589116|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589117|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589118|NCT00955487|O6|Outcome|1000-1250g Placebo (Nitrogen)|"Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589119|NCT00955487|O5|Outcome|1000-1250g Inhaled Nitric Oxide (iNO)|"Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589120|NCT00955487|O4|Outcome|750-999g Placebo (Nitrogen)|"Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589121|NCT00955487|O3|Outcome|750-999g Inhaled Nitric Oxide (iNO)|"Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589122|NCT00955487|O2|Outcome|500-749g Placebo (Nitrogen)|"Participants weighing between 500 and 749 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589123|NCT00955487|O1|Outcome|500-749g Inhaled Nitric Oxide (iNO)|"Participants weighing between 500 and 749 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
589124|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589125|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589213|NCT00955955|O4|Outcome|Adjunct Placebo Phase II|Patients received placebo for the second 4 weeks of the study. Patients who received placebo in phase 2 also received it in phase 1.
589126|NCT00955487|E2|Reported Event|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589127|NCT00955487|E1|Reported Event|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
589128|NCT00955513|B4|Baseline|Total|Total of all reporting groups
589129|NCT00955513|B3|Baseline|Placebo. Applied 3 Times a Day.|placebo
589130|NCT00955513|B2|Baseline|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
589131|NCT00955513|B1|Baseline|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
589132|NCT00955513|P3|Participant Flow|Placebo. Applied 3 Times a Day.|placebo
589133|NCT00955513|P2|Participant Flow|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
589134|NCT00955513|P1|Participant Flow|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
589135|NCT00955513|O3|Outcome|Placebo. Applied 3 Times a Day.|placebo
589136|NCT00955513|O2|Outcome|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
589137|NCT00955513|O1|Outcome|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
589138|NCT00955513|E3|Reported Event|Placebo. Applied 3 Times a Day.|placebo
589139|NCT00955513|E2|Reported Event|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
589140|NCT00955513|E1|Reported Event|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
589141|NCT00955617|B1|Baseline|All Patients|All Patients received both product Dotarem and Gadovist during 2 enhanced-MRA. Demographic analysis was performed on the global population.
589142|NCT00955617|P2|Participant Flow|Gadovist Then Dotarem|Cross over administration: patient received first Gadovist enhanced-MRA (MRA1) and then Dotarem enhanced-MRA (MRA2)
589143|NCT00955617|P1|Participant Flow|Dotarem Then Gadovist|Cross over administration, patient received first Dotarem enhanced-MRA (MRA1) and then Gadovist enhanced-MRA (MRA2)
589144|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
589153|NCT00955721|B2|Baseline|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:
Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
589154|NCT00955721|B1|Baseline|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:
Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
589155|NCT00955721|P2|Participant Flow|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:
Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
589156|NCT00955721|P1|Participant Flow|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:
Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
589157|NCT00955721|O2|Outcome|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:
Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
589158|NCT00955721|O1|Outcome|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:
Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
589159|NCT00955721|O2|Outcome|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:
Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
589214|NCT00955955|O3|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase II|Patients received Deplin for 4 weeks.
589160|NCT00955721|O1|Outcome|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:
Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
589161|NCT00955721|E2|Reported Event|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:
Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
589162|NCT00955721|E1|Reported Event|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:
Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
589163|NCT00955747|B3|Baseline|Total|Total of all reporting groups
589164|NCT00955747|B2|Baseline|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
589165|NCT00955747|B1|Baseline|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
589166|NCT00955747|P2|Participant Flow|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
589167|NCT00955747|P1|Participant Flow|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
589168|NCT00955747|O2|Outcome|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
589169|NCT00955747|O1|Outcome|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
589170|NCT00955747|E2|Reported Event|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
589171|NCT00955747|E1|Reported Event|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
589172|NCT00955825|B3|Baseline|Total|Total of all reporting groups
589173|NCT00955825|B2|Baseline|Placebo|Placebo tablet
589174|NCT00955825|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
589175|NCT00955825|P2|Participant Flow|Placebo|Placebo tablet
589176|NCT00955825|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
589177|NCT00955825|O2|Outcome|Placebo|Placebo tablet
589178|NCT00955825|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
589179|NCT00955825|E2|Reported Event|Placebo|Placebo tablet
589180|NCT00955825|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
589181|NCT00955903|B4|Baseline|Total|Total of all reporting groups
589182|NCT00955903|B3|Baseline|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet"
589183|NCT00955903|B2|Baseline|Control|"Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions"
589184|NCT00955903|B1|Baseline|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet"
589185|NCT00955903|P3|Participant Flow|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet"
589186|NCT00955903|P2|Participant Flow|Control|"Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions"
589187|NCT00955903|P1|Participant Flow|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet"
589188|NCT00955903|O3|Outcome|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet"
589189|NCT00955903|O2|Outcome|Control|"Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions"
589215|NCT00955955|O2|Outcome|Adjunct Placebo Phase I|Patients who received placebo for 4 weeks.
589224|NCT00955955|E1|Reported Event|Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF).
589190|NCT00955903|O1|Outcome|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet"
589191|NCT00955903|O3|Outcome|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet"
589192|NCT00955903|O2|Outcome|Control|"Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions"
589193|NCT00955903|O1|Outcome|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet"
589194|NCT00955903|O3|Outcome|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet"
589195|NCT00955903|O2|Outcome|Control|"Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions"
589196|NCT00955903|O1|Outcome|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet"
589197|NCT00955903|E3|Reported Event|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet"
589198|NCT00955903|E2|Reported Event|Control|"Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions"
589199|NCT00955903|E1|Reported Event|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet"
589200|NCT00955916|B1|Baseline|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).
Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).
CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
589237|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.
Platelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix"
589270|NCT00965484|B1|Baseline|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
589201|NCT00955916|P1|Participant Flow|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).
Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).
CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
589202|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).
Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).
CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
589203|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).
Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).
CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
589204|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).
Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).
CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
589205|NCT00955916|E1|Reported Event|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).
Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).
CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
589206|NCT00955955|B4|Baseline|Total|Total of all reporting groups
589207|NCT00955955|B3|Baseline|Placebo/Placebo|Both tablets of study medication will be placebo during both phases of the study.
589208|NCT00955955|B2|Baseline|Placebo/Deplin|Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
589209|NCT00955955|B1|Baseline|Deplin/Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
589210|NCT00955955|P3|Participant Flow|Placebo/Placebo|Both tablets of study medication will be placebo during both phases of the study.
589297|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
589225|NCT00956020|B1|Baseline|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589226|NCT00956020|P1|Participant Flow|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589227|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 12 weeks after treatment.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589228|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 10 weeks after treatment.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589229|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589230|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 week after treatment.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589231|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589232|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 30 minutes after treatment.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589233|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 12 weeks after treatment.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589234|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 10 weeks after treatment.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589235|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.
Platelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix"
589236|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 weeks after treatment.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589342|NCT00966238|B4|Baseline|3.0 µg i.m.|
589238|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a period from 30 minutes to 12 weeks after treatment.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589239|NCT00956020|E1|Reported Event|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
589240|NCT00965341|B3|Baseline|Total|Total of all reporting groups
589241|NCT00965341|B2|Baseline|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
589242|NCT00965341|B1|Baseline|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
589243|NCT00965341|P2|Participant Flow|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
589244|NCT00965341|P1|Participant Flow|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
589245|NCT00965341|O2|Outcome|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
589246|NCT00965341|O1|Outcome|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
589247|NCT00965341|O2|Outcome|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
589248|NCT00965341|O1|Outcome|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
589249|NCT00965341|E2|Reported Event|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
589250|NCT00965341|E1|Reported Event|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
589251|NCT00965458|B3|Baseline|Total|Total of all reporting groups
589252|NCT00965458|B2|Baseline|Placebo|"Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
589253|NCT00965458|B1|Baseline|Alefacept|"Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
589254|NCT00965458|P2|Participant Flow|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589255|NCT00965458|P1|Participant Flow|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589256|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589257|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589258|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589259|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589260|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589261|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589262|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589263|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589264|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589265|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
589266|NCT00965458|O2|Outcome|Placebo|"Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
589267|NCT00965458|O1|Outcome|Alefacept|"Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
589268|NCT00965458|E2|Reported Event|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
589269|NCT00965458|E1|Reported Event|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
589271|NCT00965484|P1|Participant Flow|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
589272|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
589273|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
589274|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
589275|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
589276|NCT00965484|E1|Reported Event|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
589277|NCT00965497|B1|Baseline|Open-label, Single Arm|All patients will receive the intervention
589278|NCT00965497|P1|Participant Flow|Open-label, Single Arm|All patients will receive the intervention
589279|NCT00965497|O1|Outcome|Escitalopram|One-arm study of escitalopram 20 mg daily
589280|NCT00965497|O1|Outcome|Escitalopram|One-arm study of escitalopram 20 mg daily
589281|NCT00965497|E1|Reported Event|Open-label, Single Arm|All patients will receive the intervention
589282|NCT00965523|B1|Baseline|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
589283|NCT00965523|P1|Participant Flow|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
589284|NCT00965523|O1|Outcome|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
589285|NCT00965523|O1|Outcome|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
589286|NCT00965523|E1|Reported Event|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
589287|NCT00965562|B4|Baseline|Total|Total of all reporting groups
589288|NCT00965562|B3|Baseline|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
589289|NCT00965562|B2|Baseline|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
589290|NCT00965562|B1|Baseline|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
589291|NCT00965562|P3|Participant Flow|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
589292|NCT00965562|P2|Participant Flow|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
589293|NCT00965562|P1|Participant Flow|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
589294|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
589295|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
589296|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
589311|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
589312|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
589313|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
589314|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
589315|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 5 cycles, women will receive placebo.
589316|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
589317|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
589318|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
589319|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
589320|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
589321|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 5 cycles, women will receive placebo.
589322|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
589323|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
589324|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
589325|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
589326|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
589327|NCT00965562|E3|Reported Event|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
589328|NCT00965562|E2|Reported Event|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
589329|NCT00965562|E1|Reported Event|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
589330|NCT00966186|B3|Baseline|Total|Total of all reporting groups
589331|NCT00966186|B2|Baseline|Rotational Technique|
589332|NCT00966186|B1|Baseline|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
589333|NCT00966186|P2|Participant Flow|Rotational Technique|
589334|NCT00966186|P1|Participant Flow|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
589335|NCT00966186|O2|Outcome|Rotational Technique|
589336|NCT00966186|O1|Outcome|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
589337|NCT00966186|E2|Reported Event|Rotational Technique|
589338|NCT00966186|E1|Reported Event|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
589339|NCT00966238|B7|Baseline|Total|Total of all reporting groups
589340|NCT00966238|B6|Baseline|8.0 µg i.m.|
589341|NCT00966238|B5|Baseline|5.0 µg i.m.|
589354|NCT00966238|O4|Outcome|3.0 µg i.m.|
589355|NCT00966238|O3|Outcome|2.0 µg i.m.|
589356|NCT00966238|O2|Outcome|1.0 µg i.m.|
589357|NCT00966238|O1|Outcome|0.5 µg i.m.|
589358|NCT00966238|O6|Outcome|8.0 µg i.m.|
589359|NCT00966238|O5|Outcome|5.0 µg i.m.|
589360|NCT00966238|O4|Outcome|3.0 µg i.m.|
589361|NCT00966238|O3|Outcome|2.0 µg i.m.|
589362|NCT00966238|O2|Outcome|1.0 µg i.m.|
589363|NCT00966238|O1|Outcome|0.5 µg i.m.|
589364|NCT00966238|E6|Reported Event|8.0 µg i.m.|
589365|NCT00966238|E5|Reported Event|5.0 µg i.m.|
589366|NCT00966238|E4|Reported Event|3.0 µg i.m.|
589367|NCT00966238|E3|Reported Event|2.0 µg i.m.|
589368|NCT00966238|E2|Reported Event|1.0 µg i.m.|
589369|NCT00966238|E1|Reported Event|0.5 µg i.m.|
589370|NCT00966264|B3|Baseline|Total|Total of all reporting groups
589371|NCT00966264|B2|Baseline|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
589372|NCT00966264|B1|Baseline|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
589373|NCT00966264|P2|Participant Flow|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
589374|NCT00966264|P1|Participant Flow|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
589375|NCT00966264|O2|Outcome|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
589376|NCT00966264|O1|Outcome|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
589377|NCT00966264|E2|Reported Event|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
589378|NCT00966264|E1|Reported Event|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
589379|NCT00966277|B3|Baseline|Total|Total of all reporting groups
589380|NCT00966277|B2|Baseline|Group 2: Control|No Dalteparin study drug.
589381|NCT00966277|B1|Baseline|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
589382|NCT00966277|P2|Participant Flow|Group 2: Control|No Dalteparin study drug (primary prophylaxis).
589383|NCT00966277|P1|Participant Flow|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
589384|NCT00966277|O2|Outcome|Group 2: Control|No Dalteparin study drug.
589385|NCT00966277|O1|Outcome|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
589386|NCT00966277|E2|Reported Event|Group 2: Control|No Dalteparin study drug.
589387|NCT00966277|E1|Reported Event|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
589388|NCT00966446|B4|Baseline|Total|Total of all reporting groups
589389|NCT00966446|B3|Baseline|No Intervention|Households do not undergo active MRSA decolonization protocol. The received education only. The content of the education focused on personal hygiene (hand hygiene and bathing), interrupting transmission (avoidance of shared towels, razors, etc.), and household hygiene (regular washing of linens and towels, disposal of potentially infective materials such as bandages).
589390|NCT00966446|B2|Baseline|Supervised Decolonization|This group was also randomized to the decolonization protocol. In addition those randomized to supervised decolonization received daily phone calls or text messages during the decolonization protocol period in order to remind enrolled subjects to perform the indicated procedure in addition to the instruction and education received during the initial interview.
589391|NCT00966446|B1|Baseline|Unsupervised Decolonization|"This group was randomized to the following decolonization protocol: 1) 2% mupirocin ointment applied inside both nares twice daily for seven days 2) a 4% chlorhexidine gluconate (Hibiclens, Mo¨lnlycke Health Care, Norcross, Georgia) body wash, including entire skin surface, excluding face and hair, with particular attention to axillae, inguinal region, and perirectal areas, performed on both the first and the last day of mupirocin use. Subjects were asked to record performance of each step of the decolonization protocol in a journal, which was returned at the end of the period of medication use, along with any unused portion of the mupirocin and chlorhexidine gluconate body wash containers. The subjects randomized to unsupervised decolonization were instructed on the decolonization protocol during the initial interview, along with the educational instruction as described in the no intervention group."
589392|NCT00966446|P3|Participant Flow|No Intervention|Households do not undergo active MRSA decolonization protocol
589393|NCT00966446|P2|Participant Flow|Supervised Decolonization|"Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members.
Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns."
589394|NCT00966446|P1|Participant Flow|Unsupervised Decolonization|"Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.
Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member."
589395|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
589396|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
589397|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
589398|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
589399|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
589400|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
589401|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
589402|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
589403|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
589404|NCT00966446|E3|Reported Event|No Intervention|Households do not undergo active MRSA decolonization protocol
589405|NCT00966446|E2|Reported Event|Supervised Decolonization|"Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members.
Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns."
589406|NCT00966446|E1|Reported Event|Unsupervised Decolonization|"Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.
Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member."
589407|NCT00966550|B3|Baseline|Total|Total of all reporting groups
589408|NCT00966550|B2|Baseline|Non-tomato First Then Tomato|"Non-tomato high fat test meal
Non-tomato test meal: non-tomato with High fat test meal"
589409|NCT00966550|B1|Baseline|Tomato First Then Non-tomato|"tomato High fat test meal
Tomato products: tomato with High fat test meal"
589410|NCT00966550|P2|Participant Flow|Non-tomato First Then Tomato|Non-tomato :High fat meal with non-tomato
589411|NCT00966550|P1|Participant Flow|Tomato First Then Non-tomato|Tomato :High fat meal with tomato
589412|NCT00966550|O2|Outcome|Non-tomato|"Non-tomato high fat test meal
Non-tomato test meal: High fat non-tomato test meal"
589413|NCT00966550|O1|Outcome|Tomato|"High fat tomato test meal
Tomato products: High fat tomato test meal"
589414|NCT00966550|E2|Reported Event|Non-tomato|"Non-tomato high fat test meal
Non-tomato test meal: High fat non-tomato test meal"
589415|NCT00966550|E1|Reported Event|Tomato|"High fat tomato test meal
Tomato products: High fat tomato test meal"
589416|NCT00966641|B1|Baseline|All Study Participants|All study participants who were enrolled in the study.
589417|NCT00966641|P2|Participant Flow|Naproxen First, Then PL3100|"First Intervention Period:
Naproxen: Single orally administered dose of 500 mg naproxen
(after 7-14 day washout period)
Second Intervention Period:
PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)"
589418|NCT00966641|P1|Participant Flow|PL3100 First, Then Naproxen|"First Intervention Period:
PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)
(after 7-14 day washout period)
Second Intervention Period:
Naproxen: Single orally administered dose of 500 mg naproxen"
589419|NCT00966641|O2|Outcome|Naproxen|"Active comparator
Naproxen: Single orally administered dose of 500 mg naproxen"
589420|NCT00966641|O1|Outcome|PL 3100|"Active experimental drug
PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)"
589421|NCT00966641|E2|Reported Event|Naproxen|"Active comparator
Naproxen: Single orally administered dose of 500 mg naproxen"
589422|NCT00966641|E1|Reported Event|PL 3100|"Active experimental drug
PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)"
589423|NCT00966654|B1|Baseline|All Study Participants|"GLP-1 (7-36) amide
GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
589424|NCT00966654|P1|Participant Flow|GLP-1|"GLP-1 (7-36) amide
GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.
OR
Placebo (saline)"
589425|NCT00966654|O2|Outcome|Saline|"Saline
Placebo: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
589426|NCT00966654|O1|Outcome|GLP-1|"GLP-1 (7-36) amide
GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
589427|NCT00966654|O2|Outcome|Saline|"Saline
Placebo: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
589428|NCT00966654|O1|Outcome|GLP-1|"GLP-1 (7-36) amide
GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
589429|NCT00966654|E2|Reported Event|Saline|"Saline
Placebo: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
589430|NCT00966654|E1|Reported Event|GLP-1|"GLP-1 (7-36) amide
GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
589431|NCT00966823|B1|Baseline|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion
Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.
- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
589455|NCT00966875|P3|Participant Flow|10 mg LY2439821 [bDMARD-naive Population]|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
591561|NCT00972153|B1|Baseline|No Device Used|
589432|NCT00966823|P1|Participant Flow|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion
Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.
- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
589433|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion
Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.
- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
589434|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion
Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.
- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
589435|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion
Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.
- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
589436|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion
Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.
- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
589437|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion
Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.
- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
589438|NCT00966823|E1|Reported Event|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion
Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.
- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
589439|NCT00966875|B10|Baseline|Total|Total of all reporting groups
589440|NCT00966875|B9|Baseline|180 mg LY2439821 [TNFα-IR Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589441|NCT00966875|B8|Baseline|80 mg LY2439821 [TNFα-IR Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589442|NCT00966875|B7|Baseline|Placebo [TNFα-IR Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589443|NCT00966875|B6|Baseline|180 mg LY2439821[bDMARD-naive Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589444|NCT00966875|B5|Baseline|80 mg LY2439821 [bDMARD-naive Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589445|NCT00966875|B4|Baseline|30 mg LY2439821 [bDMARD-naive Population|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589446|NCT00966875|B3|Baseline|10 mg LY2439821 [bDMARD-naive Population]|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589447|NCT00966875|B2|Baseline|3 mg LY2439821 [bDMARD-naive Population]|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589448|NCT00966875|B1|Baseline|Placebo [bDMARD-naive Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589449|NCT00966875|P9|Participant Flow|180 mg LY2439821 [TNFα-IR Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589450|NCT00966875|P8|Participant Flow|80 mg LY2439821 [TNFα-IR Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589451|NCT00966875|P7|Participant Flow|Placebo [TNFα-IR Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)]
589452|NCT00966875|P6|Participant Flow|180 mg LY2439821[bDMARD-naive Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589453|NCT00966875|P5|Participant Flow|80 mg LY2439821 [bDMARD-naive Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589454|NCT00966875|P4|Participant Flow|30 mg LY2439821 [bDMARD-naive Population]|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589542|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589456|NCT00966875|P2|Participant Flow|3 mg LY2439821 [bDMARD-naive Population]|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589457|NCT00966875|P1|Participant Flow|Placebo [bDMARD-naive Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 milligrams (mg) LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)]
589458|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589459|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589460|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589461|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589462|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589463|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589464|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589465|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589466|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589467|NCT00966875|O8|Outcome|Part B: 160 mg LY2439821 (bDMARD-naive and TNFα-IR Population)|160 mg LY2439821 administered subcutaneously at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60, in Part B.
589468|NCT00966875|O7|Outcome|Part A: 180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589469|NCT00966875|O6|Outcome|Part A: 80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589470|NCT00966875|O5|Outcome|Part A: 180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589471|NCT00966875|O4|Outcome|Part A: 80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589472|NCT00966875|O3|Outcome|Part A: 30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589473|NCT00966875|O2|Outcome|Part A: 10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589474|NCT00966875|O1|Outcome|Part A: 3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589475|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589476|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589477|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589478|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589479|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589480|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589481|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589482|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589483|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589484|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589485|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589486|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589487|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589488|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589489|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589490|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589491|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589492|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589493|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589494|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589495|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589788|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589496|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589497|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589498|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589499|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589500|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589501|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589502|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589503|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589504|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589505|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589506|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589507|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589508|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589509|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589510|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589511|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589512|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589513|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589514|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589515|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589516|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589517|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589518|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589519|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589520|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589521|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589522|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589523|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589524|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589525|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589526|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589527|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589528|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589529|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589530|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589531|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589532|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589533|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589534|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589535|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589536|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589537|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589538|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589539|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589540|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589541|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
590281|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
589543|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589544|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589545|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589546|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589547|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589548|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589549|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589550|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589551|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589552|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589553|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589554|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589654|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589555|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589556|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589557|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589558|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589559|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589560|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589561|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589562|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589563|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589564|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589565|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589566|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589567|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589568|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589569|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589570|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589571|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589572|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589573|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589574|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589575|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589576|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589577|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589578|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589579|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589580|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589581|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589582|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589583|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589584|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589585|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589586|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589587|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589588|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589589|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589590|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589591|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589592|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589593|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589594|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589595|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population])|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589596|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589597|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589598|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589599|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589600|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589601|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589602|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589603|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589604|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589605|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589606|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589607|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589608|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589609|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589610|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589611|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589612|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589613|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589614|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589615|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589616|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589617|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589618|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589619|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589620|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589902|NCT00967226|O1|Outcome|Vascular AEs Propranolol|Number of participants experiencing Vascular AEs
589621|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589622|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589623|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589624|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589625|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589626|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589627|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589628|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589629|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589630|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589631|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589632|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589633|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589634|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589635|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589636|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589637|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589638|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589639|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589640|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589641|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589642|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589643|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589644|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589645|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589646|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589647|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589648|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589649|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589650|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589651|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589652|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589653|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589655|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589656|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589657|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589658|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589659|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589660|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589661|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589662|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589663|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589664|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589665|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589666|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589667|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589668|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589669|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589670|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589671|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589672|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589704|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
591562|NCT00972153|P3|Participant Flow|Device Deployed and Activated|
589673|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589674|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589675|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589676|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589677|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589678|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589679|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589680|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589681|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589682|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589683|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589684|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589685|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
590259|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
589686|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589687|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589688|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589689|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589690|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589691|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589692|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589693|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589694|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589695|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589696|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589697|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589698|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589699|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589700|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589701|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589702|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589703|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589705|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589706|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589707|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 milligram (mg) LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589708|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589709|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589710|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589711|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589712|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589713|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589714|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589715|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589716|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589754|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589717|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589718|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589719|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589720|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589721|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589722|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589723|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589724|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589725|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589726|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589727|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821(TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589728|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821(TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589729|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589730|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589731|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821(bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589732|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821(bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589733|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821(bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589734|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821(bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
590021|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
589735|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589736|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589737|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589738|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589739|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589740|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589741|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589742|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589743|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589744|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589745|NCT00966875|O1|Outcome|3 mg to 180 mg LY2439821 (bDMARD-naive Population)|3 mg to 180 mg LY2439821administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589746|NCT00966875|O1|Outcome|3 mg to 180 mg (bDMARD-naive Population)|3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589747|NCT00966875|O1|Outcome|3 mg to 180 mg LY2439821 (bDMARD-naive Population)|3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589748|NCT00966875|O3|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589749|NCT00966875|O2|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589750|NCT00966875|O1|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589751|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589752|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589753|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589755|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589756|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
589757|NCT00966875|E18|Reported Event|Placebo/160 mg LY2439821 (TNFa-IR Population) Part B|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589758|NCT00966875|E17|Reported Event|180 mg/160 mg LY2439821 (TNFa-IR Population) Part B|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589759|NCT00966875|E16|Reported Event|80 mg/160 mg LY2439821 (TNFa-IR Population) Part B|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589760|NCT00966875|E15|Reported Event|Placebo/160 mg LY2439821 (bDMARD-naive Population) Part B|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589761|NCT00966875|E14|Reported Event|180 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589762|NCT00966875|E13|Reported Event|80 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589763|NCT00966875|E12|Reported Event|30 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589764|NCT00966875|E11|Reported Event|10 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589765|NCT00966875|E10|Reported Event|3 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589766|NCT00966875|E9|Reported Event|Placebo (TNFa-IR Population) Part A|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589767|NCT00966875|E8|Reported Event|180 mg LY2439821 (TNFa-IR Population) Part A|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589768|NCT00966875|E7|Reported Event|80 mg LY2439821 (TNFa-IR Population) Part A|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
590022|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
589769|NCT00966875|E6|Reported Event|Placebo (bDMARD-naive Population) Part A|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589770|NCT00966875|E5|Reported Event|180 mg LY2439821(bDMARD-naive Population) Part A|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589771|NCT00966875|E4|Reported Event|80 mg LY2439821 (bDMARD-naive Population) Part A|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589772|NCT00966875|E3|Reported Event|30 mg LY2439821 (bDMARD-naive Population) Part A|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589773|NCT00966875|E2|Reported Event|10 mg LY2439821 (bDMARD-naive Population) Part A|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589774|NCT00966875|E1|Reported Event|3 mg LY2439821 (bDMARD-naive Population) Part A|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
589775|NCT00966940|B3|Baseline|Total|Total of all reporting groups
589776|NCT00966940|B2|Baseline|Tafluprost-to-travoprost|Tafluprost, then travoprost
589777|NCT00966940|B1|Baseline|Travoprost-to-tafluprost|Travoprost, then tafluprost
589778|NCT00966940|P2|Participant Flow|Tafluprost-to-travoprost|Tafluprost, then travoprost
589779|NCT00966940|P1|Participant Flow|Travoprost-to-tafluprost|Travoprost, then tafluprost
589780|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589781|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589782|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589783|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589784|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589785|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589786|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589787|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
600173|NCT00995930|O1|Outcome|Placebo|SQ monthly
589789|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589790|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589791|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589792|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589793|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589794|NCT00966940|E2|Reported Event|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589795|NCT00966940|E1|Reported Event|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
589796|NCT00966953|B5|Baseline|Total|Total of all reporting groups
589797|NCT00966953|B4|Baseline|Magnolol, Total/Whitening, Honokiol, Fluoride Control|1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
589798|NCT00966953|B3|Baseline|Honokiol, Fluoride Control, Magnolol, Total/Whitening|1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
589799|NCT00966953|B2|Baseline|Total/Whitening, Honokiol, Fluoride Control, Magnolol|1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
589800|NCT00966953|B1|Baseline|Fluoride Control, Magnolol,Total/Whitening,Honokiol|1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
589801|NCT00966953|P4|Participant Flow|Magnolol, Total/Whitening, Honokiol, Fluoride Control|1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
589802|NCT00966953|P3|Participant Flow|Honokiol, Fluoride Control, Magnolol, Total/Whitening|1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
589803|NCT00966953|P2|Participant Flow|Total/Whitening, Honokiol, Fluoride Control, Magnolol|1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
589804|NCT00966953|P1|Participant Flow|Fluoride Control, Magnolol,Total/Whitening,Honokiol|1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
589805|NCT00966953|O4|Outcome|Herbal Extract Toothpaste|Fluoride/Magnolol extract toothpaste
589806|NCT00966953|O3|Outcome|Herbal Extract Toothpaste|Fluoride/Honokiol extract toothpaste
589807|NCT00966953|O2|Outcome|Total/Whitening|Control toothpaste
589808|NCT00966953|O1|Outcome|Fluoride Only|Control toothopaste
589809|NCT00966992|B3|Baseline|Total|Total of all reporting groups
589810|NCT00966992|B2|Baseline|Arm 2 (Zometa)|"Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
Zoledronic acid"
590023|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
589811|NCT00966992|B1|Baseline|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
589812|NCT00966992|P2|Participant Flow|Arm 2 (Zometa)|"Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
Zoledronic acid"
589813|NCT00966992|P1|Participant Flow|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
589814|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
589815|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
589816|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
589817|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
589818|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
589819|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
589820|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
590260|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
589821|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
589822|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
589823|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
589824|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
589825|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
589826|NCT00966992|E2|Reported Event|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
589827|NCT00966992|E1|Reported Event|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
589828|NCT00967005|B3|Baseline|Total|Total of all reporting groups
589829|NCT00967005|B2|Baseline|Sugar Pill|Sugar Pill: placebo control
589830|NCT00967005|B1|Baseline|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589831|NCT00967005|P2|Participant Flow|Sugar Pill|Sugar Pill: placebo control
589832|NCT00967005|P1|Participant Flow|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589833|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589926|NCT00967226|E1|Reported Event|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas
propranolol: propranolol 0.5 mg/kg p.o. QID 6 months or less"
589834|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589835|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589836|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589837|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589838|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589839|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589840|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589841|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589842|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589843|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589844|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589845|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589846|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589847|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589848|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589849|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589850|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589851|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589852|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589853|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589854|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589855|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589856|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589857|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589858|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589859|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589860|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589861|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589862|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589863|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589864|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589865|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589866|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589867|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589868|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589869|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589870|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589871|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589872|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589873|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589874|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589875|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589876|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589877|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589878|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589879|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
589880|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589881|NCT00967005|E2|Reported Event|Sugar Pill|Sugar Pill: placebo control
589882|NCT00967005|E1|Reported Event|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
589903|NCT00967226|O2|Outcome|Metabolic/Laboratory AEs Prednisolone|Number of participants experiencing Metabolic or Laboratory AEs in each study arm.
589904|NCT00967226|O1|Outcome|Metabolic/Laboratory AEs Propranolol|Number of participants experiencing Metabolic or Laboratory AEs.
589905|NCT00967226|O2|Outcome|Infectious AEs Prednisolone|Number of participants experiencing Infectious AEs
589883|NCT00967018|B1|Baseline|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
589884|NCT00967018|P1|Participant Flow|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
589885|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
589886|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
589887|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
589927|NCT00967330|B3|Baseline|Total|Total of all reporting groups
590328|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
589888|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
589889|NCT00967018|E1|Reported Event|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
589890|NCT00967044|B1|Baseline|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)
Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by participants), three times per week.
Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
589891|NCT00967044|P1|Participant Flow|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)
Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week
Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
589892|NCT00967044|O1|Outcome|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)
Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week
Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
589893|NCT00967044|E1|Reported Event|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)
Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week
Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
589894|NCT00967226|B3|Baseline|Total|Total of all reporting groups
589895|NCT00967226|B2|Baseline|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.
Prednisolone: 1.0 mg/kg p.o. BID x 4-6 months (2.0 mg/kg/day)"
589896|NCT00967226|B1|Baseline|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas
Propranolol 0.67 mg/kg p.o. TID x 4 - 6 months (2.0 mg/kg/day)"
589897|NCT00967226|P2|Participant Flow|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.
Prednisolone: 1.0 mg/kg p.o. BID 4-6 months"
589898|NCT00967226|P1|Participant Flow|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas
propranolol: propranolol 0.67 mg/kg p.o. TID 4-6 months"
589899|NCT00967226|O2|Outcome|Constitutional AEs Prednisolone|Number of Participants experiencing Constitutional AEs
589900|NCT00967226|O1|Outcome|Constitutional AEs Propranolol|Number of Participants experiencing Constitutional AEs
589901|NCT00967226|O2|Outcome|Vascular AEs Prednisolone|Number of participants experiencing Vascular AEs
589906|NCT00967226|O1|Outcome|Infectious AEs Propranolol|Number of participants experiencing Infectious AEs
589907|NCT00967226|O2|Outcome|Gastrointestinal AEs Prednisolone|Number of Participants experiencing Gastrointestinal AEs
589908|NCT00967226|O1|Outcome|Gastrointestinal AEs Propranolol|Number of Participants experiencing Gastrointestinal AEs
589909|NCT00967226|O2|Outcome|Endocrinologic AEs Prednisolone|Number of participants experiencing Endocrinologic AEs.
589910|NCT00967226|O1|Outcome|Endocrine AEs Propranolol|Number of participants experiencing Endocrinologic AEs.
589911|NCT00967226|O2|Outcome|Dermatologic AEs Prednisolone|Number of participants experiencing Dermatologic AEs
589912|NCT00967226|O1|Outcome|Dermatologic AEs Propranolol|Number of participants experiencing Dermatologic AEs
589913|NCT00967226|O2|Outcome|Allergy/Immunology Events Prednisolone|Adverse events in allergy/immunology in prednisolone treated participants
589914|NCT00967226|O1|Outcome|Allergy/Immunology Events Propranolol|Adverse events in allergy/immunology in propranolol treated participants
589915|NCT00967226|O2|Outcome|Pulmonary/Respiratory AEs Prednisolone|Number of participants experiencing pulmonary/respiratory AEs
589916|NCT00967226|O1|Outcome|Pulmonary/Respiratory AEs Propranolol|Number of participants experiencing pulmonary/respiratory AEs
589917|NCT00967226|O2|Outcome|Growth/Development AEs Prednisolone|Number of participants experiencing Growth/Development AEs
589918|NCT00967226|O1|Outcome|Growth/Developoment AEs Propranolol|Number of participants experiencing Growth/Development AEs
589919|NCT00967226|O2|Outcome|Number of Serious Adverse Events in Prednisolone|Serious adverse events in prednisolone treated participants
589920|NCT00967226|O1|Outcome|Number of Serious Adverse Events in Propranolol|Serious adverse events in propranolol treated participants.
589921|NCT00967226|O2|Outcome|Overall Number of Adverse Events in Prednisolone|"All (total) study adverse events displayed as Adverse events including mild, moderate, and severe; as well as Serious Adverse Events"
589922|NCT00967226|O1|Outcome|Overall Number of Adverse Events in Propranolol|"All (total) study adverse events displayed as Adverse events including mild, moderate, and severe; as well as Serious Adverse Events"
589923|NCT00967226|O2|Outcome|Prednisolone|"A priori analysis, TSA (length x width) at baseline versus at 4 months with surrogate data at 5 months
Prednisolone: 1.0 mg/kg p.o. BID x 4-6 months (2.0 mg/kg/day)"
589924|NCT00967226|O1|Outcome|Propranolol|A priori analysis, TSA (length x width) at baseline versus at 4 months with surrogate data at 5 months Propranolol 0.67 mg/kg p.o. TID x 4 - 6 months (2.0 mg/kg/day)
589925|NCT00967226|E2|Reported Event|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.
Prednisolone: 1.0 mg/kg p.o. BID x 6 months or less"
590329|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
589928|NCT00967330|B2|Baseline|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589929|NCT00967330|B1|Baseline|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589930|NCT00967330|P2|Participant Flow|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589931|NCT00967330|P1|Participant Flow|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589932|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589933|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589934|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589935|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589936|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
590015|NCT00968019|B1|Baseline|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590016|NCT00968019|P1|Participant Flow|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590413|NCT00960622|B2|Baseline|Combivir, Trizivir.|continue on Combivir, trizivir.
589937|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589938|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589939|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589940|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589941|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589973|NCT00967486|B1|Baseline|Routine Shunt|routine methods of CEA
589974|NCT00967486|P2|Participant Flow|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
589975|NCT00967486|P1|Participant Flow|Routine Shunt|Routine method of CEA
589976|NCT00967486|O2|Outcome|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
589942|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589943|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589944|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589945|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589946|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589947|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589948|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589949|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589950|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589977|NCT00967486|O1|Outcome|Routine Shunt|routine methods of CEA
589978|NCT00967486|E2|Reported Event|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
589979|NCT00967486|E1|Reported Event|Routine Shunt|routine methods of CEA
589980|NCT00967551|B3|Baseline|Total|Total of all reporting groups
590438|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
589951|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589952|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589953|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589954|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
589955|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589956|NCT00967330|E2|Reported Event|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator or and, if eligible.
589957|NCT00967330|E1|Reported Event|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
589958|NCT00967447|B1|Baseline|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
589959|NCT00967447|P1|Participant Flow|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
589960|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
589961|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
589962|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
589963|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
589964|NCT00967447|E1|Reported Event|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
589965|NCT00967473|B1|Baseline|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
589966|NCT00967473|P1|Participant Flow|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
589967|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
589968|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
589969|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
589970|NCT00967473|E1|Reported Event|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
589971|NCT00967486|B3|Baseline|Total|Total of all reporting groups
589972|NCT00967486|B2|Baseline|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
589981|NCT00967551|B2|Baseline|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate
Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
589982|NCT00967551|B1|Baseline|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc
Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
589983|NCT00967551|P2|Participant Flow|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate
Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
589984|NCT00967551|P1|Participant Flow|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc
Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
589985|NCT00967551|O2|Outcome|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate
Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
589986|NCT00967551|O1|Outcome|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc
Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
589987|NCT00967551|O2|Outcome|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate
Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
589988|NCT00967551|O1|Outcome|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc
Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
589989|NCT00967551|E2|Reported Event|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate
Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
589990|NCT00967551|E1|Reported Event|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc
Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
589991|NCT00967668|B4|Baseline|Total|Total of all reporting groups
589992|NCT00967668|B3|Baseline|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
590017|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590018|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590019|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590414|NCT00960622|B1|Baseline|Truvada|switch from Combivir to Truvada
589993|NCT00967668|B2|Baseline|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)
Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
589994|NCT00967668|B1|Baseline|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)
Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
589995|NCT00967668|P3|Participant Flow|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
589996|NCT00967668|P2|Participant Flow|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)
Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
589997|NCT00967668|P1|Participant Flow|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)
Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
589998|NCT00967668|O3|Outcome|Arm 3|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
589999|NCT00967668|O2|Outcome|Arm 2|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)
Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
590000|NCT00967668|O1|Outcome|Arm 1|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)
Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
590001|NCT00967668|O3|Outcome|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
590020|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590002|NCT00967668|O2|Outcome|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)
Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
590003|NCT00967668|O1|Outcome|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)
Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
590004|NCT00967668|E3|Reported Event|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
590005|NCT00967668|E2|Reported Event|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)
Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
590006|NCT00967668|E1|Reported Event|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)
Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
590007|NCT00967694|B1|Baseline|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
590196|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590197|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590008|NCT00967694|P1|Participant Flow|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
590009|NCT00967694|O1|Outcome|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline (prior to nitrous oxide administration) and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore one study arm, with each individual serving as their control for baseline (before nitrous oxide administration) and then intervention values of IOP measurement (during nitrous oxide administration), and then washout values of IOP (after breathing room air).
590010|NCT00967694|E1|Reported Event|Nitrous Oxide Administration|20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
590011|NCT00967993|B1|Baseline|KRX-0502|All subjects in this group will receive treatment with KRX-0502, 1g ferric citrate containing approximately 210 mg of ferric iron
590012|NCT00967993|P1|Participant Flow|KRX-0502|"All patients initiated on study drug were started on a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day. Patients were titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels went below normal, there was a decrease in pills; if serum phosphorus levels went above normal, there was an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day was 12, or 12 g/day of ferric citrate."
590013|NCT00967993|O1|Outcome|KRX-0502 (Ferric Citrate)|Single arm clinical trial of KRX-0502 (ferric citrate)
590014|NCT00967993|E1|Reported Event|KRX-0502 (Ferric Citrate)|Single arm clinical trial of KRX-0502 (ferric citrate)
590024|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590025|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590026|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590027|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590028|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590029|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590030|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590031|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590032|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590033|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590034|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590035|NCT00968019|E1|Reported Event|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
590036|NCT00968032|B1|Baseline|Nit-Occlud® PFO|
590037|NCT00968032|P1|Participant Flow|Nit-Occlud® PFO Implantation Group|Patients suffering from PFO and suitable for closure of the defect with the Nit-Occlud® PFO Closure Device
590038|NCT00968032|O1|Outcome|Nit-Occlud® PFO|
590039|NCT00968032|E1|Reported Event|Nit-Occlud® PFO|
590040|NCT00968071|B1|Baseline|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
590041|NCT00968071|P1|Participant Flow|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 intravenously (IV) over an hour and half daily for 5 days plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
590042|NCT00968071|O1|Outcome|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
590043|NCT00968071|E1|Reported Event|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
590044|NCT00968149|B3|Baseline|Total|Total of all reporting groups
590045|NCT00968149|B2|Baseline|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
590046|NCT00968149|B1|Baseline|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
590047|NCT00968149|P2|Participant Flow|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
590048|NCT00968149|P1|Participant Flow|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
590049|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
590050|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
590051|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
590052|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
590053|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
590054|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
590055|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
590056|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
590057|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
590058|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
590330|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590059|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
590060|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
590061|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
590062|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
590063|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
590064|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
590065|NCT00968149|E2|Reported Event|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
590066|NCT00968149|E1|Reported Event|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
590067|NCT00968201|B3|Baseline|Total|Total of all reporting groups
590068|NCT00968201|B2|Baseline|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590069|NCT00968201|B1|Baseline|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590070|NCT00968201|P3|Participant Flow|Montelukast|"Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at
their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together."
590198|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590199|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590071|NCT00968201|P2|Participant Flow|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some
patients receiving montelukast in Period II were switched to usual care in the Extension Study.
Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590072|NCT00968201|P1|Participant Flow|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590073|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590074|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590075|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590076|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590077|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590135|NCT00960297|B1|Baseline|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab
Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
590331|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590078|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590079|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590080|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590081|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590082|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590083|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590084|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590200|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590201|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590085|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590086|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590087|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590088|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590089|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590136|NCT00960297|P1|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab
Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
590090|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590091|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590092|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590093|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590094|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590095|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590096|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590097|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590439|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590098|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590099|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590100|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590101|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590137|NCT00960297|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab
Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
590332|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590102|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590103|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
590104|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590105|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590106|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590107|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590108|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590109|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590110|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590111|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590112|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590113|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590114|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590115|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590116|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590117|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590118|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590119|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590120|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590121|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590122|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590123|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590124|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590125|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
590126|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590202|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590127|NCT00968201|E3|Reported Event|Montelukast|"Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at
their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together."
590128|NCT00968201|E2|Reported Event|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some
patients receiving montelukast in Period II were switched to usual care in the Extension Study.
Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
590129|NCT00968201|E1|Reported Event|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
590130|NCT00968227|B1|Baseline|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
590131|NCT00968227|P1|Participant Flow|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
590132|NCT00968227|O1|Outcome|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
590133|NCT00968227|O1|Outcome|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
590134|NCT00968227|E1|Reported Event|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
590280|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590138|NCT00960297|E1|Reported Event|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab
Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
590139|NCT00960323|B1|Baseline|Colchicine, Atorvastatin, Colchicine and Atorvastatin|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
590140|NCT00960323|P1|Participant Flow|Colchicine, Atorvastatin, Colchicine and Atorvastatin|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
590141|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
590142|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
590143|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
590144|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
590145|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
590146|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast followed by a 14 day washout period.
590147|NCT00960323|E3|Reported Event|Colchicine and Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
590148|NCT00960323|E2|Reported Event|Atorvastatin Alone|On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast.
590149|NCT00960323|E1|Reported Event|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
590150|NCT00960375|B3|Baseline|Total|Total of all reporting groups
590203|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590204|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590205|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590206|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590207|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590208|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590151|NCT00960375|B2|Baseline|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
590152|NCT00960375|B1|Baseline|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
590153|NCT00960375|P2|Participant Flow|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
590154|NCT00960375|P1|Participant Flow|BTSCS|BTSCS includes two 60-minute groups/week (24 total). It is delivered in groups of 4-8 participants run by a trained interventionist. It includes: (1) individual motivational enhancement session to help participants think about personal reasons for change; (2) Breath CO monitoring and goal-setting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about negative health effects of smoking; (5) Relapse prevention; (6) Education about and assistance with nicotine replacement therapy.
590155|NCT00960375|O2|Outcome|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
590156|NCT00960375|O1|Outcome|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
590157|NCT00960375|O2|Outcome|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
590158|NCT00960375|O1|Outcome|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
590209|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590210|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590211|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590212|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
591192|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
590159|NCT00960375|E2|Reported Event|StSST|The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups provide education about smoking and support for quitting. Smoking education groups involve weekly (24 groups total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
590160|NCT00960375|E1|Reported Event|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
590161|NCT00960440|B5|Baseline|Total|Total of all reporting groups
590162|NCT00960440|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590163|NCT00960440|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590164|NCT00960440|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590165|NCT00960440|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590166|NCT00960440|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590167|NCT00960440|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590168|NCT00960440|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590169|NCT00960440|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
590170|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590171|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590172|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590173|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590174|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590175|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590176|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590177|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590178|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590179|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590180|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590181|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590182|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590183|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590184|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590185|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590186|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590187|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590188|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590189|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590190|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590191|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590192|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590193|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590194|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590195|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590213|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590214|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590215|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590216|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590217|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590218|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590219|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590220|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590221|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590222|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590223|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590224|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590225|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590226|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590227|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590228|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590229|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590230|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590231|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590232|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
591563|NCT00972153|P2|Participant Flow|Device Attached, Not Activated|
590233|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590234|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590235|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590236|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590237|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590238|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590239|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590240|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590241|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590242|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590243|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590244|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590245|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590246|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590247|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590248|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590249|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590250|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590251|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590252|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590253|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590254|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590255|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590256|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590257|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590258|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
600174|NCT00995930|E2|Reported Event|Placebo|SQ monthly
590261|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590262|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590263|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590264|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590265|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590266|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590267|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590268|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590269|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590270|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590271|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590272|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590273|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590274|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590275|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590276|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590277|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590278|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590279|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590282|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590283|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590284|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590285|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590286|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590287|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590288|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590289|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590290|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590291|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590292|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590293|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590294|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590295|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590296|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590297|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590298|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590299|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590300|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590301|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590302|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590303|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590304|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590305|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590306|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
600175|NCT00995930|E1|Reported Event|ACZ885 150mg|ACZ885 150mg
590307|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590308|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590309|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590310|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590311|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590312|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590313|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590314|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590315|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590316|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590317|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
590318|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
590319|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590320|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590321|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590322|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590323|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590324|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590325|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
590326|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
590327|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
590333|NCT00960440|E5|Reported Event|CP-690,550 10 mg From Month 3 to 6|CP-690,550 10 mg tablets orally twice daily from Month 3 to Month 6.
590334|NCT00960440|E4|Reported Event|CP-690,550 5 mg From Month 3 to 6|CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
590335|NCT00960440|E3|Reported Event|Placebo Up to Month 3|Placebo matching to CP-690,550 5 mg tablet orally twice daily up to Month 3.
590336|NCT00960440|E2|Reported Event|CP-690,550 10 mg Up to Month 3|CP-690,550 10 mg tablets orally twice daily up to Month 3.
590337|NCT00960440|E1|Reported Event|CP-690,550 5 mg Up to Month 3|CP-690,550 5 mg tablet orally twice daily up to Month 3.
590338|NCT00960531|B11|Baseline|Total|Total of all reporting groups
590339|NCT00960531|B10|Baseline|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590340|NCT00960531|B9|Baseline|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590341|NCT00960531|B8|Baseline|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590342|NCT00960531|B7|Baseline|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590343|NCT00960531|B6|Baseline|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590344|NCT00960531|B5|Baseline|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590345|NCT00960531|B4|Baseline|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590346|NCT00960531|B3|Baseline|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590347|NCT00960531|B2|Baseline|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590348|NCT00960531|B1|Baseline|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590349|NCT00960531|P10|Participant Flow|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590350|NCT00960531|P9|Participant Flow|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590351|NCT00960531|P8|Participant Flow|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590352|NCT00960531|P7|Participant Flow|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590353|NCT00960531|P6|Participant Flow|PBS / ACC 10 µg+QS-21|Participants received Phosphate buffered Saline (PBS) in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590354|NCT00960531|P5|Participant Flow|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590355|NCT00960531|P4|Participant Flow|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590356|NCT00960531|P3|Participant Flow|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590357|NCT00960531|P2|Participant Flow|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590358|NCT00960531|P1|Participant Flow|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590359|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590360|NCT00960531|O9|Outcome|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590411|NCT00960570|E1|Reported Event|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
590361|NCT00960531|O8|Outcome|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590362|NCT00960531|O7|Outcome|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590363|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590364|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590365|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590366|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590367|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590368|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590369|NCT00960531|O6|Outcome|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590370|NCT00960531|O5|Outcome|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590371|NCT00960531|O4|Outcome|Control / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590372|NCT00960531|O3|Outcome|Active / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
591193|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
590373|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590374|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590375|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590376|NCT00960531|O9|Outcome|QS-21 / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590377|NCT00960531|O8|Outcome|ACC 30 μg / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590378|NCT00960531|O7|Outcome|ACC 30 μg+QS-21 / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590379|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590380|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590381|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590382|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590383|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590384|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590385|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590412|NCT00960622|B3|Baseline|Total|Total of all reporting groups
590386|NCT00960531|O9|Outcome|QS-21 / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590387|NCT00960531|O8|Outcome|ACC 30 μg / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590388|NCT00960531|O7|Outcome|ACC 30 μg+QS-21 / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590389|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590390|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590391|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590392|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590393|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590394|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590395|NCT00960531|E6|Reported Event|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590396|NCT00960531|E5|Reported Event|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590397|NCT00960531|E4|Reported Event|Control / ACC 10µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590440|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
591194|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
590398|NCT00960531|E3|Reported Event|Active / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590399|NCT00960531|E2|Reported Event|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590400|NCT00960531|E1|Reported Event|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
590401|NCT00960570|B1|Baseline|Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
590402|NCT00960570|P1|Participant Flow|Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
590403|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
590404|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
590405|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
590406|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
590407|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
590408|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
590409|NCT00960570|E3|Reported Event|Efavirenz and Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
590410|NCT00960570|E2|Reported Event|Fenofibric Acid Alone|On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
590415|NCT00960622|P2|Participant Flow|Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.|The study subjects will be randomly assigned to continue on Combivir or trizivir.This will serve as comparator group.
590416|NCT00960622|P1|Participant Flow|Truvada 200/300 mg, Daily, by Mouth.|The study subjects will be randomly assigned to switch from Combivir or from trizivir to open-label Truvada.
590417|NCT00960622|O2|Outcome|Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.|continue on Combivir 150/300 mg, or trizivir 300/150/300 mg daily.
590418|NCT00960622|O1|Outcome|Truvada 200/300 mg, Daily, by Mouth.|switch from Combivir or trizivir to Truvada 200/300 mg, daily, by mouth.
590419|NCT00960622|E2|Reported Event|Combivir, Trizivir.|continue on Combivir, trizivir.
590420|NCT00960622|E1|Reported Event|Truvada|switch from Combivir to Truvada
590421|NCT00960661|B3|Baseline|Total|Total of all reporting groups
590422|NCT00960661|B2|Baseline|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590423|NCT00960661|B1|Baseline|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590424|NCT00960661|P3|Participant Flow|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590425|NCT00960661|P2|Participant Flow|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590426|NCT00960661|P1|Participant Flow|Enrolled|Patients who enrolled in the basal insulin optimization (BIO) phase
590427|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590428|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590429|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590430|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590431|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590432|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590433|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590434|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590435|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590436|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590437|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590441|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590442|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590443|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590444|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590445|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590446|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590447|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590448|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590449|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590450|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590451|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590452|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590453|NCT00960661|E2|Reported Event|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
590454|NCT00960661|E1|Reported Event|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
590455|NCT00960687|B1|Baseline|Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg, 30 minutes after the initiation of a standard meal.
590456|NCT00960687|P2|Participant Flow|Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast.
590457|NCT00960687|P1|Participant Flow|Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast.
590458|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
590459|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
590460|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
590461|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
590462|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
590502|NCT00960869|B1|Baseline|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590463|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
590464|NCT00960687|E2|Reported Event|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg 30 minutes after the initiation of a standard breakfast.
590465|NCT00960687|E1|Reported Event|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105 mg 30 minutes after the initiation of a standard breakfast.
590466|NCT00960843|B3|Baseline|Total|Total of all reporting groups
590467|NCT00960843|B2|Baseline|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
590468|NCT00960843|B1|Baseline|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
590469|NCT00960843|P2|Participant Flow|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
590470|NCT00960843|P1|Participant Flow|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
590471|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
590472|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
590473|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
590474|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
590475|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
590476|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
590477|NCT00960843|E2|Reported Event|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
590478|NCT00960843|E1|Reported Event|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
590479|NCT00960856|B1|Baseline|Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted|All subjects received each of the four study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8, 15 and 22 each subject received one tablet of fenofibric acid 105 mg administered after one of the following meal conditions: 1) low-fat meal, 2) standard meal, 3) high-fat/high-calorie meal 4) overnight fast of at least 10 hours.
590480|NCT00960856|P4|Participant Flow|Sequence DABC|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
590481|NCT00960856|P3|Participant Flow|Sequence CDAB|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
590482|NCT00960856|P2|Participant Flow|Sequence BCDA|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
590483|NCT00960856|P1|Participant Flow|Sequence ABCD|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
590484|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
590485|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
590486|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
590487|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
590488|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
590489|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
590490|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
590491|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
590492|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
590493|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
590494|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
590495|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
590496|NCT00960856|E4|Reported Event|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid following an overnight fast of at least 10 hours.
590497|NCT00960856|E3|Reported Event|High-fat, High-calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
590498|NCT00960856|E2|Reported Event|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
590499|NCT00960856|E1|Reported Event|Low-Fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
590500|NCT00960869|B3|Baseline|Total|Total of all reporting groups
590501|NCT00960869|B2|Baseline|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590503|NCT00960869|P2|Participant Flow|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590504|NCT00960869|P1|Participant Flow|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590505|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590506|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590507|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590508|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590509|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590510|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590511|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590512|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590513|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590514|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590515|NCT00960869|E2|Reported Event|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590516|NCT00960869|E1|Reported Event|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590517|NCT00960934|B7|Baseline|Total|Total of all reporting groups
590518|NCT00960934|B6|Baseline|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590519|NCT00960934|B5|Baseline|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590520|NCT00960934|B4|Baseline|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590521|NCT00960934|B3|Baseline|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590522|NCT00960934|B2|Baseline|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590523|NCT00960934|B1|Baseline|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590524|NCT00960934|P6|Participant Flow|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590525|NCT00960934|P5|Participant Flow|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590526|NCT00960934|P4|Participant Flow|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590527|NCT00960934|P3|Participant Flow|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590528|NCT00960934|P2|Participant Flow|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590529|NCT00960934|P1|Participant Flow|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590530|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590531|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590532|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590533|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590534|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590535|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590536|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590537|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590538|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590539|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590540|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590541|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590654|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590542|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590543|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590544|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590545|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590546|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590547|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590548|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590549|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590550|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590551|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590552|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590553|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590554|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590555|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590556|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590557|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
591195|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
590558|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590559|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590560|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590561|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590562|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590563|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590564|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590565|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590566|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590567|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590568|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590569|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590570|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590571|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590572|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590573|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590574|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590575|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590576|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590577|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
591564|NCT00972153|P1|Participant Flow|No Device Used|
590578|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590579|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590580|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590581|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590582|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590583|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590584|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590585|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590586|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590587|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590588|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590589|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590590|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590591|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590592|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590593|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590676|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590594|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590595|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590596|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590597|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590598|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590599|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590600|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590601|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590602|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590603|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590604|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590605|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590606|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590607|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590608|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590609|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590610|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590611|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590612|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590613|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590614|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590615|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590616|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590617|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590618|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590619|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590620|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590621|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590622|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590623|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590624|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590625|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590626|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590627|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590628|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590629|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590677|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590630|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590631|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590632|NCT00960934|E6|Reported Event|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
590633|NCT00960934|E5|Reported Event|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
590634|NCT00960934|E4|Reported Event|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
590635|NCT00960934|E3|Reported Event|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
590636|NCT00960934|E2|Reported Event|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
590637|NCT00960934|E1|Reported Event|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
590638|NCT00960986|B5|Baseline|Total|Total of all reporting groups
590639|NCT00960986|B4|Baseline|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590640|NCT00960986|B3|Baseline|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590641|NCT00960986|B2|Baseline|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590642|NCT00960986|B1|Baseline|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590643|NCT00960986|P4|Participant Flow|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590644|NCT00960986|P3|Participant Flow|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590645|NCT00960986|P2|Participant Flow|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590646|NCT00960986|P1|Participant Flow|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590647|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590648|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590649|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590650|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590651|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590652|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590653|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590655|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590656|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590657|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590658|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590659|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590660|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590661|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590662|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590663|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590664|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590665|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590666|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590667|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590668|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590669|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590670|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590671|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590672|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590673|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590674|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590675|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590678|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590679|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590680|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590681|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590682|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590683|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590684|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590685|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590686|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590687|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590688|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590689|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590690|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590691|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590692|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590693|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590694|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590695|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590696|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590697|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590698|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590699|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590700|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590701|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590702|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590703|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590704|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590705|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590706|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590707|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590708|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590709|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590710|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590711|NCT00960986|E4|Reported Event|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
590712|NCT00960986|E3|Reported Event|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
590713|NCT00960986|E2|Reported Event|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
590714|NCT00960986|E1|Reported Event|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
590715|NCT00960999|B3|Baseline|Total|Total of all reporting groups
590716|NCT00960999|B2|Baseline|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
590717|NCT00960999|B1|Baseline|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
590718|NCT00960999|P2|Participant Flow|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
590719|NCT00960999|P1|Participant Flow|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
590720|NCT00960999|O2|Outcome|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
590721|NCT00960999|O1|Outcome|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
590722|NCT00960999|E2|Reported Event|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
590723|NCT00960999|E1|Reported Event|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
590724|NCT00961051|B3|Baseline|Total|Total of all reporting groups
590725|NCT00961051|B2|Baseline|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
590726|NCT00961051|B1|Baseline|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
590727|NCT00961051|P2|Participant Flow|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
590728|NCT00961051|P1|Participant Flow|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
590729|NCT00961051|O2|Outcome|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
590730|NCT00961051|O1|Outcome|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
590731|NCT00961051|O2|Outcome|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
590732|NCT00961051|O1|Outcome|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
590733|NCT00961051|E2|Reported Event|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
590734|NCT00961051|E1|Reported Event|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
590735|NCT00961116|B1|Baseline|Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg following an overnight fast.
590736|NCT00961116|P2|Participant Flow|Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference, fenofibrate 145 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, after an overnight fast.
590737|NCT00961116|P1|Participant Flow|Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, after an overnight fast.
590738|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
590739|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
590740|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
590741|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
590742|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
590743|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
590744|NCT00961116|E2|Reported Event|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
590745|NCT00961116|E1|Reported Event|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105 mg after an overnight fast of at least 10 hours.
590746|NCT00961181|B1|Baseline|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590747|NCT00961181|P1|Participant Flow|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclusion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590748|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590749|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590750|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590751|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590752|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590753|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590754|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590755|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590756|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590757|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590758|NCT00961181|E1|Reported Event|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
590790|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
590791|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
591196|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
590759|NCT00961220|B1|Baseline|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590760|NCT00961220|P1|Participant Flow|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590761|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590762|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590763|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590810|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
590811|NCT00961298|E1|Reported Event|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
590812|NCT00961311|B1|Baseline|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
590764|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590765|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590766|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590767|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590768|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590792|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
591197|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
590769|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590770|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590771|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590772|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590773|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV
carmustine: Applied topically
laboratory biomarker analysis: Correlative studies"
590850|NCT00961402|E1|Reported Event|Wellness Control|"Participants will receive health and wellness information and no exercise information.
Exercise: 6-month exercise intervention vs. wellness control"
590774|NCT00961220|E1|Reported Event|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour
Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).
laboratory biomarker analysis: Correlative studies"
590775|NCT00961233|B3|Baseline|Total|Total of all reporting groups
590776|NCT00961233|B2|Baseline|Viscous/Swallowed Budesonide|
590777|NCT00961233|B1|Baseline|Inhaled/Swallowed Budesonide|
590778|NCT00961233|P2|Participant Flow|Viscous/Swallowed Budesonide|viscous/swallowed budesonide - budesonide slurry (created with 5g sucralose) 1 mg twice daily that is swallowed
590779|NCT00961233|P1|Participant Flow|Inhaled/Swallowed Budesonide|inhaled/swallowed budesonide - nebulized budesonide 1mg twice daily that is swallowed.
590780|NCT00961233|O2|Outcome|Viscous/Swallowed Budesonide|viscous slurry of budesonide and sucralose 1 mg twice daily
590781|NCT00961233|O1|Outcome|Inhaled/Swallowed Budesonide|nebulized then swallowed budesonide 1mg twice daily
590782|NCT00961233|O2|Outcome|Viscous/Swallowed Budesonide|
590783|NCT00961233|O1|Outcome|Inhaled/Swallowed Budesonide|
590784|NCT00961233|E2|Reported Event|Viscous/Swallowed Budesonide|
590785|NCT00961233|E1|Reported Event|Inhaled/Swallowed Budesonide|
590786|NCT00961259|B1|Baseline|Fenofibric Acid - Treatments A, B and C|All subjects received each of the three study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8 and 15 each subject received either one 35 mg fenofibric acid tablet (treatment A), three 35 mg fenofibric acid tablets (105 mg total dose, treatment B) or one 105 mg fenofibric acid tablet (treatment C).
590787|NCT00961259|P3|Participant Flow|Treatment Sequence CAB|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B).
590788|NCT00961259|P2|Participant Flow|Treatment Sequence BCA|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A).
590789|NCT00961259|P1|Participant Flow|Treatment Sequence ABC|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (treatment B). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C).
591198|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
590793|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
590794|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
590795|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
590796|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
590797|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
590798|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
590799|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
590800|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
590801|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
590802|NCT00961259|E3|Reported Event|Fenofibric Acid 105 mg (1 x 105 mg Tablet), Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
590803|NCT00961259|E2|Reported Event|Fenofibric Acid 105 mg (3 x 35 mg Tablet), Treatment B|Each subject received three (3) tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
590804|NCT00961259|E1|Reported Event|Fenofibric Acid 35 mg (1 x 35 mg Tablet), Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
590805|NCT00961298|B1|Baseline|Treatment Arm|every subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
590806|NCT00961298|P1|Participant Flow|Treatment Arm|Every study eligible subject entered a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
590807|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
590808|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
590809|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
590851|NCT00961415|B3|Baseline|Total|Total of all reporting groups
590813|NCT00961311|P1|Participant Flow|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
590814|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
590815|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
590816|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
590817|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
590818|NCT00961311|E1|Reported Event|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
590819|NCT00961350|B3|Baseline|Total|Total of all reporting groups
590820|NCT00961350|B2|Baseline|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590821|NCT00961350|B1|Baseline|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590822|NCT00961350|P2|Participant Flow|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590823|NCT00961350|P1|Participant Flow|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590824|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590825|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590826|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590827|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590828|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590829|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590830|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
591199|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
590831|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590832|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590833|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590834|NCT00961350|E2|Reported Event|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
590835|NCT00961350|E1|Reported Event|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
590836|NCT00961402|B3|Baseline|Total|Total of all reporting groups
590837|NCT00961402|B2|Baseline|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.
Exercise: 6-month exercise intervention vs. wellness control"
590838|NCT00961402|B1|Baseline|Wellness Control|"Participants will receive health and wellness information and no exercise information.
Exercise: 6-month exercise intervention vs. wellness control"
590839|NCT00961402|P2|Participant Flow|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.
Exercise: 6-month exercise intervention vs. wellness control"
590840|NCT00961402|P1|Participant Flow|Wellness Control|"Participants will receive health and wellness information and no exercise information.
Exercise: 6-month exercise intervention vs. wellness control"
590841|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.
Exercise: 6-month exercise intervention vs. wellness control"
590842|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.
Exercise: 6-month exercise intervention vs. wellness control"
590843|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.
Exercise: 6-month exercise intervention vs. wellness control"
590844|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.
Exercise: 6-month exercise intervention vs. wellness control"
590845|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.
Exercise: 6-month exercise intervention vs. wellness control"
590846|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.
Exercise: 6-month exercise intervention vs. wellness control"
590847|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.
Exercise: 6-month exercise intervention vs. wellness control"
590848|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.
Exercise: 6-month exercise intervention vs. wellness control"
590849|NCT00961402|E2|Reported Event|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.
Exercise: 6-month exercise intervention vs. wellness control"
590852|NCT00961415|B2|Baseline|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590853|NCT00961415|B1|Baseline|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590854|NCT00961415|P3|Participant Flow|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590855|NCT00961415|P2|Participant Flow|Bevacizumab Maintenance Treatment (Trt) Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590856|NCT00961415|P1|Participant Flow|Induction Treatment Phase|Bevacizumab 7.5 milligram (mg)/ kilogram (kg) + cisplatin 75 mg/m^2 + pemetrexed 500 mg/m^2 was administered intravenously (IV) every 3 weeks. Participants received 4 cycles of induction therapy.
590857|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 mcg daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590858|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy
590859|NCT00961415|O3|Outcome|No Maintenance Trt|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm...
590860|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
590861|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis.
590862|NCT00961415|O3|Outcome|No Maintenance Trt|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
590863|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis.
590864|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis.
590865|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590866|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590867|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590868|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590869|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590870|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590871|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590872|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590873|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590874|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
590908|NCT00961636|P3|Participant Flow|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
591200|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
590875|NCT00961415|E3|Reported Event|Maintenance Treatment Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
590876|NCT00961415|E2|Reported Event|Maintenance Treatment Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis
590877|NCT00961415|E1|Reported Event|No Maintenance Treatment|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm..
590878|NCT00961441|B3|Baseline|Total|Total of all reporting groups
590879|NCT00961441|B2|Baseline|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590880|NCT00961441|B1|Baseline|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590881|NCT00961441|P2|Participant Flow|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590882|NCT00961441|P1|Participant Flow|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590883|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590884|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590885|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590886|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590887|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590888|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590889|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590890|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590891|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
591049|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
590892|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590893|NCT00961441|E2|Reported Event|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590894|NCT00961441|E1|Reported Event|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily
Duration: 4-7 days"
590895|NCT00961532|B1|Baseline|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes
DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
590896|NCT00961532|P1|Participant Flow|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes
DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
590897|NCT00961532|O1|Outcome|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes
DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
590898|NCT00961532|O1|Outcome|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes
DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
590899|NCT00961532|E1|Reported Event|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes
DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
590900|NCT00961571|B1|Baseline|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine
sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
590901|NCT00961571|P1|Participant Flow|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine
sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
590902|NCT00961571|O1|Outcome|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine
sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
590903|NCT00961571|E1|Reported Event|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine
sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
590904|NCT00961636|B4|Baseline|Total|Total of all reporting groups
590905|NCT00961636|B3|Baseline|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
590906|NCT00961636|B2|Baseline|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
590907|NCT00961636|B1|Baseline|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
590909|NCT00961636|P2|Participant Flow|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
590910|NCT00961636|P1|Participant Flow|ERN/LRPT|One 1g/20 mg tablet Extended -release niacin (+) laropiprant (ERN/LRPT) once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
590911|NCT00961636|O3|Outcome|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
590912|NCT00961636|O2|Outcome|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
590913|NCT00961636|O1|Outcome|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
590914|NCT00961636|O3|Outcome|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
590915|NCT00961636|O2|Outcome|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
590916|NCT00961636|O1|Outcome|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
590917|NCT00961636|E3|Reported Event|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
590918|NCT00961636|E2|Reported Event|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
590919|NCT00961636|E1|Reported Event|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
590920|NCT00961649|B5|Baseline|Total|Total of all reporting groups
590921|NCT00961649|B4|Baseline|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590922|NCT00961649|B3|Baseline|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590923|NCT00961649|B2|Baseline|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590924|NCT00961649|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590925|NCT00961649|P4|Participant Flow|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590926|NCT00961649|P3|Participant Flow|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590927|NCT00961649|P2|Participant Flow|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590928|NCT00961649|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590929|NCT00961649|O2|Outcome|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590930|NCT00961649|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590931|NCT00961649|O3|Outcome|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590932|NCT00961649|O2|Outcome|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590933|NCT00961649|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590934|NCT00961649|E4|Reported Event|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590935|NCT00961649|E3|Reported Event|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590936|NCT00961649|E2|Reported Event|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590937|NCT00961649|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
590938|NCT00961662|B4|Baseline|Total|Total of all reporting groups
590939|NCT00961662|B3|Baseline|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
590940|NCT00961662|B2|Baseline|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
590941|NCT00961662|B1|Baseline|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
590942|NCT00961662|P3|Participant Flow|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
590943|NCT00961662|P2|Participant Flow|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
590944|NCT00961662|P1|Participant Flow|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
590945|NCT00961662|O3|Outcome|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
590946|NCT00961662|O2|Outcome|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
590947|NCT00961662|O1|Outcome|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
590948|NCT00961662|E3|Reported Event|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
590949|NCT00961662|E2|Reported Event|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
590950|NCT00961662|E1|Reported Event|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
590951|NCT00961805|B3|Baseline|Total|Total of all reporting groups
590952|NCT00961805|B2|Baseline|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home
590953|NCT00961805|B1|Baseline|Group Control|The waiting list
590954|NCT00961805|P2|Participant Flow|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590955|NCT00961805|P1|Participant Flow|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590956|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590957|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590958|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590959|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590960|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590961|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590962|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590963|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590964|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590965|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590966|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590967|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
591018|NCT00962013|P1|Participant Flow|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
590968|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590969|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590970|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590971|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590972|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590973|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590974|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590975|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
591000|NCT00961896|O3|Outcome|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
LDE225 0.25%"
591001|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
Vehicle: Placebo cream"
590976|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590977|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590978|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590979|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590980|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
590981|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
590982|NCT00961896|B4|Baseline|Total|Total of all reporting groups
590983|NCT00961896|B3|Baseline|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
LDE225 0.75%"
590984|NCT00961896|B2|Baseline|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
LDE225 0.25%"
590985|NCT00961896|B1|Baseline|All Part I Participants|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
LDE225 0.75%"
591103|NCT00962390|B3|Baseline|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
590986|NCT00961896|P3|Participant Flow|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
LDE225 0.75%"
590987|NCT00961896|P2|Participant Flow|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
LDE225 0.25%"
590988|NCT00961896|P1|Participant Flow|All Part I Participants|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
LDE225 0.75%"
590989|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
Vehicle: Placebo cream"
590990|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
LDE225 0.75%"
590991|NCT00961896|O2|Outcome|LDE225 0.75% [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
590992|NCT00961896|O1|Outcome|LDE225 0.25% [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
590993|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
Vehicle: Placebo cream"
590994|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
LDE225 0.75%"
590995|NCT00961896|O2|Outcome|LDE225 0.75% [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
590996|NCT00961896|O1|Outcome|LDE225 0.25% [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
590997|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
Vehicle: Placebo cream"
590998|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
LDE225 0.75%"
590999|NCT00961896|O4|Outcome|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
LDE225 0.75%"
591002|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
LDE225 0.75%"
591003|NCT00961896|E3|Reported Event|0.75% LDE225 [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
591004|NCT00961896|E2|Reported Event|0.25% LDE225 [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
591005|NCT00961896|E1|Reported Event|All Part I Participants|Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
591006|NCT00962000|B1|Baseline|All Study Participants|All subjects who participated in the study.
591007|NCT00962000|P2|Participant Flow|800 mL/Min First|Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.
591008|NCT00962000|P1|Participant Flow|600 mL/Min First|Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
591009|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
591010|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
591011|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
591012|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
591013|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
591014|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
591015|NCT00962000|E2|Reported Event|800 mL/Min First|Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.
591016|NCT00962000|E1|Reported Event|600 mL/Min First|Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
591017|NCT00962013|B1|Baseline|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
591191|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
591019|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
591020|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
591021|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
591022|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
591023|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
591024|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
591025|NCT00962013|E1|Reported Event|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
591026|NCT00962065|B4|Baseline|Total|Total of all reporting groups
591027|NCT00962065|B3|Baseline|Placebo|Matching placebo dosing with daily oral intake for 28 days
591028|NCT00962065|B2|Baseline|High Dose|A high dose of LX4211; daily oral intake for 28 days
591029|NCT00962065|B1|Baseline|Low Dose|A low dose of LX4211; daily oral intake for 28 days
591030|NCT00962065|P3|Participant Flow|Placebo|Matching placebo dosing with daily oral intake for 28 days
591031|NCT00962065|P2|Participant Flow|High Dose|A high dose of LX4211; daily oral intake for 28 days
591032|NCT00962065|P1|Participant Flow|Low Dose|A low dose of LX4211; daily oral intake for 28 days
591033|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
591034|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
591035|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
591036|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
591037|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
591038|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
591039|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
591040|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
591041|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
591042|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
591043|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
591044|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
591045|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
591046|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
591047|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
591048|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
591050|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
591051|NCT00962065|E3|Reported Event|Placebo|Matching placebo dosing with daily oral intake for 28 days
591052|NCT00962065|E2|Reported Event|High Dose|A high dose of LX4211; daily oral intake for 28 days
591053|NCT00962065|E1|Reported Event|Low Dose|A low dose of LX4211; daily oral intake for 28 days
591054|NCT00962104|B3|Baseline|Total|Total of all reporting groups
591055|NCT00962104|B2|Baseline|Placebo|Taken by mouth, once daily for 10 weeks.
591056|NCT00962104|B1|Baseline|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591057|NCT00962104|P2|Participant Flow|Placebo|Taken by mouth, once daily for 10 weeks.
591058|NCT00962104|P1|Participant Flow|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591059|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
591060|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591061|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
591062|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591063|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
591064|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591065|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
591066|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591067|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
591068|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591069|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
600876|NCT00996775|B3|Baseline|Total|Total of all reporting groups
591070|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591071|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
591072|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591073|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
591074|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591075|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
591076|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591077|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
591078|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591079|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
591080|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591081|NCT00962104|E2|Reported Event|Placebo|Taken by mouth, once daily for 10 weeks.
591082|NCT00962104|E1|Reported Event|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
591083|NCT00962208|B3|Baseline|Total|Total of all reporting groups
591084|NCT00962208|B2|Baseline|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
591085|NCT00962208|B1|Baseline|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
591086|NCT00962208|P2|Participant Flow|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
591087|NCT00962208|P1|Participant Flow|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
591088|NCT00962208|O2|Outcome|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
591089|NCT00962208|O1|Outcome|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
591090|NCT00962208|E2|Reported Event|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
591091|NCT00962208|E1|Reported Event|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
591092|NCT00962247|B1|Baseline|Usual Sedentary|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
591093|NCT00962247|P1|Participant Flow|Sedentary; Usual, 25% Reduced, 50% Reduced|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
591094|NCT00962247|O3|Outcome|50% Sedentary Reduction|"Children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 50% from the usual sedentary condition using a television reduction device (TV Allowance)
Television reduction device: A TV allowance helps turn off the television when the time limits have been met."
591095|NCT00962247|O2|Outcome|25% Sedentary Reduction|"Children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 25% from the usual sedentary condition using a television reduction device (TV Allowance)
Television reduction device: A TV allowance helps turn off the television when the time limits have been met."
591096|NCT00962247|O1|Outcome|Usual Sedentary|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
591097|NCT00962247|O3|Outcome|50% Sedentary Reduction|"Children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 50% from the usual sedentary condition using a television reduction device (TV Allowance)
Television reduction device: A TV allowance helps turn off the television when the time limits have been met."
591098|NCT00962247|O2|Outcome|25% Sedentary Reduction|"Children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 25% from the usual sedentary condition using a television reduction device (TV Allowance)
Television reduction device: A TV allowance helps turn off the television when the time limits have been met."
591099|NCT00962247|O1|Outcome|Usual Sedentary|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
591100|NCT00962247|E1|Reported Event|Usual Sedentary|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
591101|NCT00962390|B5|Baseline|Total|Total of all reporting groups
591102|NCT00962390|B4|Baseline|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
601690|NCT00999141|O3|Outcome|No Preference|
591104|NCT00962390|B2|Baseline|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591105|NCT00962390|B1|Baseline|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591106|NCT00962390|P4|Participant Flow|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591107|NCT00962390|P3|Participant Flow|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591108|NCT00962390|P2|Participant Flow|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591109|NCT00962390|P1|Participant Flow|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591110|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591111|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591112|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591113|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591114|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591115|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591116|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591117|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591118|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591119|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591120|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591121|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591122|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591123|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591124|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591125|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591126|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591127|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591128|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591129|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591130|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591131|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591132|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591133|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591134|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591135|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591136|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591137|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591138|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591139|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591140|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591141|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591142|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591143|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
601691|NCT00999141|O2|Outcome|Somewhat Prefer FS VH S/D 4 S-apr Side|
591144|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591145|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591146|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591147|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591148|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591149|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591150|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591151|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591152|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591153|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591154|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591155|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591156|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591157|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591158|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591159|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591160|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591161|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591162|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
591163|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
591164|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
591165|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
591265|NCT00968669|B2|Baseline|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591166|NCT00962390|E4|Reported Event|Placebo BID|"Placebo Comparator: Placebo
Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks.
At-risk Participants were subjects who received at least one dose of S-at any time during the study."
591167|NCT00962390|E3|Reported Event|S-equol 150 mg BID|"Experimental: S-equol
Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks.
At-risk Participants were subjects who received at least one dose of S-at any time during the study."
591168|NCT00962390|E2|Reported Event|S-equol 50 mg BID|"Experimental: S-equol
Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks.
At-risk Participants were subjects who received at least one dose of S-at any time during the study."
591169|NCT00962390|E1|Reported Event|S-equol 10 mg BID|"Experimental: S-equol
Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks.
At-risk Participants were subjects who received at least one dose of S-at any time during the study."
591170|NCT00962585|B5|Baseline|Total|Total of all reporting groups
591171|NCT00962585|B4|Baseline|Placebo|Placebo treatment arm
591172|NCT00962585|B3|Baseline|S-equol 150 mg BID|300 mg total daily dose of S-equol
591173|NCT00962585|B2|Baseline|S-equol 50 mg BID|100 mg total daily dose of S-equol
591174|NCT00962585|B1|Baseline|S-equol 10 mg BID|20 mg total daily dose of S-equol
591175|NCT00962585|P4|Participant Flow|Placebo|Placebo treatment arm
591176|NCT00962585|P3|Participant Flow|S-equol 150 mg BID|300 mg total daily dose of S-equol
591177|NCT00962585|P2|Participant Flow|S-equol 50 mg BID|100 mg total daily dose of S-equol
591178|NCT00962585|P1|Participant Flow|S-equol 10 mg BID|20 mg total daily dose of S-equol
591179|NCT00962585|O2|Outcome|Placebo|Placebo treatment arm
591180|NCT00962585|O1|Outcome|S-equol Groups Combined|The S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) were combined and regarded as a single treatment group.
591181|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
591182|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
591183|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
591184|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
591185|NCT00962585|O2|Outcome|Placebo|Placebo treatment arm
591186|NCT00962585|O1|Outcome|S-equol Groups Combined|The S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) were combined and regarded as a single treatment group.
591187|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
591188|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
591189|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
591190|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
591201|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
591202|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
591203|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
591204|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
591205|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
591206|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
591207|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
591208|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
591209|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
591210|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
591211|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
591212|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
591213|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
591214|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
591215|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
591216|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
591217|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
591218|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
591219|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
591220|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
591221|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
591222|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
591223|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
591224|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
591225|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
591226|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
591227|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
591228|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
591229|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
591230|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
591231|NCT00962585|E4|Reported Event|Placebo|Placebo treatment arm
591232|NCT00962585|E3|Reported Event|S-equol 150 mg BID|300 mg total daily dose of S-equol
591233|NCT00962585|E2|Reported Event|S-equol 50 mg BID|100 mg total daily dose of S-equol
591234|NCT00962585|E1|Reported Event|S-equol 10 mg BID|20 mg total daily dose of S-equol
591235|NCT00962598|B3|Baseline|Total|Total of all reporting groups
591236|NCT00962598|B2|Baseline|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
591237|NCT00962598|B1|Baseline|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
591238|NCT00962598|P2|Participant Flow|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
591239|NCT00962598|P1|Participant Flow|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
591240|NCT00962598|O2|Outcome|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
591241|NCT00962598|O1|Outcome|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
591242|NCT00962598|O2|Outcome|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
591243|NCT00962598|O1|Outcome|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
591288|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591244|NCT00962598|E2|Reported Event|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
591245|NCT00962598|E1|Reported Event|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
591246|NCT00962650|B1|Baseline|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
591247|NCT00962650|P1|Participant Flow|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
591248|NCT00962650|O1|Outcome|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
591249|NCT00962650|E1|Reported Event|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
591250|NCT00968617|B1|Baseline|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
591251|NCT00968617|P1|Participant Flow|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
591252|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
591253|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
591254|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
591255|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
591256|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
591257|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
591258|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
591259|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
591260|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
591261|NCT00968617|E1|Reported Event|MK-2578|
591262|NCT00968669|B5|Baseline|Total|Total of all reporting groups
591263|NCT00968669|B4|Baseline|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591264|NCT00968669|B3|Baseline|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591266|NCT00968669|B1|Baseline|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591267|NCT00968669|P4|Participant Flow|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591268|NCT00968669|P3|Participant Flow|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591269|NCT00968669|P2|Participant Flow|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591270|NCT00968669|P1|Participant Flow|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591271|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591272|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591273|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591274|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591275|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591276|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591277|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591278|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591279|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591280|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591281|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591282|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591283|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591284|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591285|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591286|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591287|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591289|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591290|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591291|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591292|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591293|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591294|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591295|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591296|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591297|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591298|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591299|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591300|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591301|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591302|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591303|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591304|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591305|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591306|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591307|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591308|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591309|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591310|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591311|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591312|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591313|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591314|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591315|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591316|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591317|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591318|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591319|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591320|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591321|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591322|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591323|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591324|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591325|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591326|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591327|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591328|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591329|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591330|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591331|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591332|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591333|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591334|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591335|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591336|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591337|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
601692|NCT00999141|O1|Outcome|Strongly Prefer FS VH S/D 4 S-apr Side|
591338|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591339|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591340|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591341|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591342|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591343|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591344|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591345|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591346|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591347|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591348|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591349|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591350|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591351|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591352|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591353|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591354|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591355|NCT00968669|E4|Reported Event|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591356|NCT00968669|E3|Reported Event|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591357|NCT00968669|E2|Reported Event|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
591358|NCT00968669|E1|Reported Event|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
591359|NCT00971204|B1|Baseline|Treatment With HeartLight|Treatment of PAF with HeartLight System PVI ablation
591360|NCT00971204|P1|Participant Flow|Treatment With EAS-AC|"Treatment of PAF with EAS-AC
CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC): PVI ablation"
591361|NCT00971204|O1|Outcome|Treatment With HeartLight|"Treatment of PAF with HeartLight System
CardioFocus HeartLight Endoscopic Ablation System: PVI ablation"
591362|NCT00971204|E1|Reported Event|Treatment With HeartLight|Treatment of PAF with HeartLight
591363|NCT00971243|B6|Baseline|Total|Total of all reporting groups
591364|NCT00971243|B5|Baseline|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591454|NCT00971620|P2|Participant Flow|Placebo/Saline|Saline intralesional injection
591365|NCT00971243|B4|Baseline|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591366|NCT00971243|B3|Baseline|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591367|NCT00971243|B2|Baseline|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591368|NCT00971243|B1|Baseline|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591369|NCT00971243|P5|Participant Flow|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591370|NCT00971243|P4|Participant Flow|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591371|NCT00971243|P3|Participant Flow|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591372|NCT00971243|P2|Participant Flow|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591373|NCT00971243|P1|Participant Flow|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591374|NCT00971243|O5|Outcome|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591375|NCT00971243|O4|Outcome|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591376|NCT00971243|O3|Outcome|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591377|NCT00971243|O2|Outcome|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591378|NCT00971243|O1|Outcome|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591379|NCT00971243|O5|Outcome|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591830|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591380|NCT00971243|O4|Outcome|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591381|NCT00971243|O3|Outcome|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591382|NCT00971243|O2|Outcome|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591383|NCT00971243|O1|Outcome|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
591384|NCT00971243|E5|Reported Event|Placebo+Met|Placebo plus Metformin
591385|NCT00971243|E4|Reported Event|Teneli 40 mg+Met|Teneligliptin 40mg plus Metformin
591386|NCT00971243|E3|Reported Event|Teneli 20 mg+Met|Teneligliptin 20mg plus Metformin
591387|NCT00971243|E2|Reported Event|Teneli 10 mg+Met|Teneligliptin 10mg plus Metformin
591388|NCT00971243|E1|Reported Event|Teneli 5mg+Met|Teneligliptin 5mg plus Metformin
591389|NCT00971282|B1|Baseline|Intra-individual Comparison|Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
591390|NCT00971282|P1|Participant Flow|Intra-individual Comparison|Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
591391|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
591392|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
591393|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
591394|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
591395|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
591396|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
591397|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
591398|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
591399|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
591400|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
591401|NCT00971282|E2|Reported Event|Differin Alone|intra-individual comparison
591402|NCT00971282|E1|Reported Event|Cetaphil + Differin|intra-individual comparison
591403|NCT00971295|B1|Baseline|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg
Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
591404|NCT00971295|P2|Participant Flow|Treatment Sequence B|"Treatment Sequence B:
Metformin period followed by washout period followed by Metformin + Eslicarbazepine acetate
850 mg metformin hydrochloride, 1200 mg ESL"
591405|NCT00971295|P1|Participant Flow|Treatment Sequence A|"Treatment Sequence A:
Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period
850 mg metformin hydrochloride, 1200 mg ESL"
591406|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
591407|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg
Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
591408|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
591409|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg
Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
591410|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
591411|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg
Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
591412|NCT00971295|E2|Reported Event|Metformin|Metformin HCl 850 mg
591413|NCT00971295|E1|Reported Event|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg
Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
591414|NCT00971425|B3|Baseline|Total|Total of all reporting groups
591415|NCT00971425|B2|Baseline|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591416|NCT00971425|B1|Baseline|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591417|NCT00971425|P2|Participant Flow|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591418|NCT00971425|P1|Participant Flow|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591419|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591651|NCT00972335|P1|Participant Flow|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.
Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
591420|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591421|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591422|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591423|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591424|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591425|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591426|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591427|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591428|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591429|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591430|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591455|NCT00971620|P1|Participant Flow|BTX-A|BTX-A intralesional injection
591431|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591432|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591433|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591434|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591435|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591436|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591437|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591438|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591439|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591440|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591441|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591442|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591443|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591444|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591445|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591446|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591447|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591448|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591449|NCT00971425|E2|Reported Event|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
591450|NCT00971425|E1|Reported Event|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
591451|NCT00971620|B3|Baseline|Total|Total of all reporting groups
591452|NCT00971620|B2|Baseline|Placebo/Saline|Saline intralesional injection
591453|NCT00971620|B1|Baseline|BTX-A|BTX-A intralesional injection
591558|NCT00972153|B4|Baseline|Total|Total of all reporting groups
591456|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591457|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591458|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591459|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591460|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591461|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591462|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591463|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591464|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591465|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591466|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591467|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591468|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591469|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591470|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591471|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591472|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591473|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591474|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591475|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591476|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591477|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591478|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591479|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591480|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
591481|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
591482|NCT00971620|E2|Reported Event|Placebo/Saline|Saline intralesional injection
591483|NCT00971620|E1|Reported Event|BTX-A|BTX-A intralesional injection
591484|NCT00971633|B1|Baseline|All Participants|All randomized participants
591485|NCT00971633|P6|Participant Flow|U.S. Tablet Then U.K. Tablet Then OE U.K. Tablet|U.S. tablet then U.K. tablet then OE U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally
591652|NCT00972335|O1|Outcome|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.
Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
591486|NCT00971633|P5|Participant Flow|U.K. Tablet Then OE U.K. Tablet Then U.S. Tablet|U.K. tablet then OE U.K. tablet then U.S. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally
591487|NCT00971633|P4|Participant Flow|OE U.K. Tablet Then U.S. Tablet Then U.K. Tablet|OE U.K. tablet then U.S. tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally
591488|NCT00971633|P3|Participant Flow|U.S. Tablet Then OE U.K. Tablet Then U.K. Tablet|U.S. tablet then OE U.K. tablet then U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K ZOFRAN (ondansetron) taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally
591489|NCT00971633|P2|Participant Flow|U.K. Tablet Then U.S. Tablet Then OE U.K. Tablet|U.K. tablet then U.S. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally /Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally.
591490|NCT00971633|P1|Participant Flow|OE U.K. Tablet Then U.K. Tablet Then U.S. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet then United States (U.S.) tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally./Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally./Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally
591491|NCT00971633|O3|Outcome|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
591492|NCT00971633|O2|Outcome|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
591493|NCT00971633|O1|Outcome|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
591494|NCT00971633|O3|Outcome|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
591495|NCT00971633|O2|Outcome|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
591496|NCT00971633|O1|Outcome|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
591497|NCT00971633|E3|Reported Event|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
591498|NCT00971633|E2|Reported Event|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
591559|NCT00972153|B3|Baseline|Device Deployed and Activated|
591499|NCT00971633|E1|Reported Event|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
591500|NCT00971750|B1|Baseline|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
591501|NCT00971750|P1|Participant Flow|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
591502|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
591503|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
591504|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively during gastric bypass
591505|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
591506|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
591507|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
591508|NCT00971750|E1|Reported Event|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
591509|NCT00971789|B1|Baseline|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
591510|NCT00971789|P1|Participant Flow|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
591751|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591511|NCT00971789|O1|Outcome|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
591512|NCT00971789|O1|Outcome|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
591513|NCT00971789|E1|Reported Event|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
591514|NCT00971841|B1|Baseline|Paclitaxel|Paclitaxel dosed at the same dose level as last dose received in original Study CA139-540 (NCT 00344552)and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest. One treatment course consisted of 49 days total.
591515|NCT00971841|P1|Participant Flow|Paclitaxel|Paclitaxel dosed at the same dose level as last dose received in original study (100 mg/m^2, 80 mg/m^2, or 60 mg/m^2) and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consisted of 49 days total.
591516|NCT00971841|O1|Outcome|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
591517|NCT00971841|O1|Outcome|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
591518|NCT00971841|E1|Reported Event|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
591519|NCT00971932|B1|Baseline|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
591520|NCT00971932|P1|Participant Flow|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
591560|NCT00972153|B2|Baseline|Device Attached, Not Activated|
591521|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
591522|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
591523|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
591524|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
591752|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591525|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
591526|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
591527|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
591528|NCT00971932|E1|Reported Event|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
591529|NCT00971997|B1|Baseline|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591530|NCT00971997|P1|Participant Flow|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591531|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591532|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591533|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591534|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591535|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591536|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591537|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591538|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591539|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591540|NCT00971997|O3|Outcome|Lispro 50/50 Three Times Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591541|NCT00971997|O2|Outcome|Lispro 50/50 Twice Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591542|NCT00971997|O1|Outcome|Lispro 50/50 Once Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591543|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591544|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591545|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591546|NCT00971997|E1|Reported Event|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
591621|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591547|NCT00972023|B1|Baseline|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
DHEA : DHEA administration will begin approxiately 14 days prior to surgery.
Surgical resection : Surgical procedure of the invasive breast cancer"
591548|NCT00972023|P1|Participant Flow|DHEA, Surgical Resection|"DHEA, surgical resection:
Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
DHEA: Administration will begin approxiately 14 days prior to surgery.
Surgical resection: Surgical procedure of the invasive breast cancer"
591549|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"DHEA, surgical resection:
Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
DHEA: Administration will begin approxiately 14 days prior to surgery.
Surgical resection: Surgical procedure of the invasive breast cancer"
591550|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"DHEA, surgical resection:
Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
DHEA: Administration will begin approxiately 14 days prior to surgery.
Surgical resection: Surgical procedure of the invasive breast cancer"
591551|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
DHEA: DHEA administration will begin approxiately 14 days prior to surgery.
Surgical resection: Surgical procedure of the invasive breast cancer"
591552|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
DHEA : DHEA administration will begin approxiately 14 days prior to surgery.
Surgical resection : Surgical procedure of the invasive breast cancer"
591553|NCT00972023|E1|Reported Event|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
DHEA : DHEA administration will begin approxiately 14 days prior to surgery.
Surgical resection : Surgical procedure of the invasive breast cancer"
591554|NCT00972088|B1|Baseline|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
591555|NCT00972088|P1|Participant Flow|a Single Arm Group, Patients With Ano Rectal Disease|patients suffering from anorectal disease with a negative standard work up to rule out crohn's disease
591556|NCT00972088|O1|Outcome|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
591557|NCT00972088|E1|Reported Event|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
591565|NCT00972153|O3|Outcome|Device Deployed and Activated|
591566|NCT00972153|O2|Outcome|Device Attached, Not Activated|
591567|NCT00972153|O1|Outcome|No Device Used|
591568|NCT00972153|O3|Outcome|Device Deployed and Activated|
591569|NCT00972153|O2|Outcome|Device Attached, Not Activated|
591570|NCT00972153|O1|Outcome|No Device Used|
591571|NCT00972153|E3|Reported Event|Device Deployed and Activated|
591572|NCT00972153|E2|Reported Event|Device Attached, Not Activated|
591573|NCT00972153|E1|Reported Event|No Device Used|
591574|NCT00972205|B1|Baseline|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.
Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
591575|NCT00972205|P1|Participant Flow|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.
Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
591576|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.
Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
591577|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.
Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
591578|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.
Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
601693|NCT00999141|O1|Outcome|Facelift Participants|
591579|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.
Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
591580|NCT00972205|E1|Reported Event|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.
Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
591581|NCT00972244|B6|Baseline|Total|Total of all reporting groups
591582|NCT00972244|B5|Baseline|Placebo|Placebo Comparator
591583|NCT00972244|B4|Baseline|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
591584|NCT00972244|B3|Baseline|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
591585|NCT00972244|B2|Baseline|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
591586|NCT00972244|B1|Baseline|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
591587|NCT00972244|P5|Participant Flow|Placebo|Placebo Comparator
591588|NCT00972244|P4|Participant Flow|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
591589|NCT00972244|P3|Participant Flow|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
591590|NCT00972244|P2|Participant Flow|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
591591|NCT00972244|P1|Participant Flow|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
591592|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
591593|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
591594|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
591595|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
591596|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
591597|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
591598|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
591599|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
591600|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
591601|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
591602|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
591603|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
591604|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
591605|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
591606|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
591607|NCT00972244|E5|Reported Event|Placebo|Placebo Comparator
591608|NCT00972244|E4|Reported Event|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
591609|NCT00972244|E3|Reported Event|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
591610|NCT00972244|E2|Reported Event|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
591611|NCT00972244|E1|Reported Event|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
591612|NCT00972283|B3|Baseline|Total|Total of all reporting groups
591851|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591613|NCT00972283|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591614|NCT00972283|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591615|NCT00972283|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591616|NCT00972283|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591617|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591618|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591619|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591620|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591753|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591622|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591623|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591624|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591625|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591626|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591627|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591628|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591629|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591630|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591631|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591732|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591632|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591633|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591634|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591635|NCT00972283|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591636|NCT00972283|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
591637|NCT00972322|B3|Baseline|Total|Total of all reporting groups
591638|NCT00972322|B2|Baseline|Placebo|Placebo to MK-8245, twice daily for 28 days
591639|NCT00972322|B1|Baseline|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
591640|NCT00972322|P2|Participant Flow|Placebo|Placebo to MK-8245, twice daily for 28 days
591641|NCT00972322|P1|Participant Flow|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
591642|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
591643|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
591644|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
591645|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
591646|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
591647|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
591648|NCT00972322|E2|Reported Event|Placebo|Placebo to MK-8245, twice daily for 28 days
591649|NCT00972322|E1|Reported Event|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
591650|NCT00972335|B1|Baseline|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.
Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
591653|NCT00972335|O1|Outcome|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.
Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
591654|NCT00972335|E1|Reported Event|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.
Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
591655|NCT00972374|B4|Baseline|Total|Total of all reporting groups
591656|NCT00972374|B3|Baseline|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
591657|NCT00972374|B2|Baseline|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591658|NCT00972374|B1|Baseline|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591659|NCT00972374|P3|Participant Flow|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
591660|NCT00972374|P2|Participant Flow|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591661|NCT00972374|P1|Participant Flow|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591662|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
591663|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591664|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591665|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
591666|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591667|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591668|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
591669|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591670|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591671|NCT00972374|E3|Reported Event|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
591672|NCT00972374|E2|Reported Event|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591673|NCT00972374|E1|Reported Event|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
591674|NCT00972478|B3|Baseline|Total|Total of all reporting groups
591733|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
592002|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
591675|NCT00972478|B2|Baseline|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591676|NCT00972478|B1|Baseline|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591677|NCT00972478|P2|Participant Flow|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591678|NCT00972478|P1|Participant Flow|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591679|NCT00972478|O2|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591680|NCT00972478|O1|Outcome|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591681|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591682|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591754|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591963|NCT00972816|P3|Participant Flow|7.5_(50)MF59|7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
591683|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591684|NCT00972478|O1|Outcome|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591685|NCT00972478|E2|Reported Event|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591686|NCT00972478|E1|Reported Event|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
591687|NCT00972504|B1|Baseline|Overall Study|Participants randomized to receive once daily GSK1004723 1000 µg nasal spray solution for 3 days or oral tablet of GSK835726 10 mg or oral capsule of cetirizine 10 mg or matching placebo of these investigational products as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591688|NCT00972504|P1|Participant Flow|Overall Study|Participants randomized to receive once daily GSK1004723 (1000 micrograms [µg]) nasal spray solution for 3 days or oral tablet of GSK835726 (10 milligram [mg]) or oral capsule of cetirizine (10 mg) or matching placebo of these investigational products as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591689|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591734|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591690|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591691|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591692|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591693|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591694|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591695|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591696|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591697|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591698|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591755|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591699|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591700|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591701|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591702|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591703|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591704|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591705|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591735|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591706|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591707|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591708|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591709|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591710|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591711|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591712|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591713|NCT00972504|E4|Reported Event|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591714|NCT00972504|E3|Reported Event|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591756|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591757|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591715|NCT00972504|E2|Reported Event|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591716|NCT00972504|E1|Reported Event|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
591717|NCT00972530|B3|Baseline|Total|Total of all reporting groups
591718|NCT00972530|B2|Baseline|Immobilisation|48 hours postinjection rest
591719|NCT00972530|B1|Baseline|Activity|Normal activity without restrictions
591720|NCT00972530|P2|Participant Flow|Immobilisation|48 hours postinjection rest
591721|NCT00972530|P1|Participant Flow|Activity|Normal activity without restrictions
591722|NCT00972530|O2|Outcome|Immobilisation|48 hours postinjection rest
591723|NCT00972530|O1|Outcome|Activity|Normal activity without restrictions
591724|NCT00972530|E2|Reported Event|Immobilisation|48 hours postinjection rest
591725|NCT00972530|E1|Reported Event|Activity|Normal activity without restrictions
591726|NCT00972543|B3|Baseline|Total|Total of all reporting groups
591727|NCT00972543|B2|Baseline|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591728|NCT00972543|B1|Baseline|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591729|NCT00972543|P2|Participant Flow|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591730|NCT00972543|P1|Participant Flow|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591731|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
592004|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
591736|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591737|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591738|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591739|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591740|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591741|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591742|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591743|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591744|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591745|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591746|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591747|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591748|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591749|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591750|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591870|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591758|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591759|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591760|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591761|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591762|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591763|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591764|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591765|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591766|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591767|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591768|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591769|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591770|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591771|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591772|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591773|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591849|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591774|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591775|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591776|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591777|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591778|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591779|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591780|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591781|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591782|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591783|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591784|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591785|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591786|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591787|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591788|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591789|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591829|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591790|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591791|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591792|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591793|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591794|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591795|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591796|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591797|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591798|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591799|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591800|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591801|NCT00972543|E2|Reported Event|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591802|NCT00972543|E1|Reported Event|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
591803|NCT00972595|B1|Baseline|All Participants|All Randomized Participants
591804|NCT00972595|P2|Participant Flow|U.K. Tablet Then OE U.K. Tablet|U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
591850|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591805|NCT00972595|P1|Participant Flow|OE U.K. Tablet Then U.K. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
591806|NCT00972595|O2|Outcome|U.K. Tablet|Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
591807|NCT00972595|O1|Outcome|OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
591808|NCT00972595|O2|Outcome|U.K. Tablet|Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
591809|NCT00972595|O1|Outcome|OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
591810|NCT00972595|E2|Reported Event|U.K. Tablet Then OE U.K. Tablet|U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
591811|NCT00972595|E1|Reported Event|OE U.K. Tablet Then U.K. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
591812|NCT00972621|B3|Baseline|Total|Total of all reporting groups
591813|NCT00972621|B2|Baseline|Viscoat|Currently marketed viscoelastic
591814|NCT00972621|B1|Baseline|Vitrax II|Investigational dispersive viscoelastic
591815|NCT00972621|P2|Participant Flow|Viscoat|Currently marketed viscoelastic
591816|NCT00972621|P1|Participant Flow|Vitrax II|Investigational dispersive viscoelastic
591817|NCT00972621|O2|Outcome|Viscoat|Viscoat: Control Treatment
591818|NCT00972621|O1|Outcome|Vitrax II|Vitrax II: Investigational Treatment
591819|NCT00972621|O2|Outcome|Viscoat|Viscoat: Control Treatment
591820|NCT00972621|O1|Outcome|Vitrax II|Vitrax II: Investigational Treatment
591821|NCT00972621|E2|Reported Event|Viscoat|Currently marketed viscoelastic
591822|NCT00972621|E1|Reported Event|Vitrax II|Investigational dispersive viscoelastic
591823|NCT00972725|B3|Baseline|Total|Total of all reporting groups
591824|NCT00972725|B2|Baseline|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591825|NCT00972725|B1|Baseline|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591826|NCT00972725|P2|Participant Flow|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591827|NCT00972725|P1|Participant Flow|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591828|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591831|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591832|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591833|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591834|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591835|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591836|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591837|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591838|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591839|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591840|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591841|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591842|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591843|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591844|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591845|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591846|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591847|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591848|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591852|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591853|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591854|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591855|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591856|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591857|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591858|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591859|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591860|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591861|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591862|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591863|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591864|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591865|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591866|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591867|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591868|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591869|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591871|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591872|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591873|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591874|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591875|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591876|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591877|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591878|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591879|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591880|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591881|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591882|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591883|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591884|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591885|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591886|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591887|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591888|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591889|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591890|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591891|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591892|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591893|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591894|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591895|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591896|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591897|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591898|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591899|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591900|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591901|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591902|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591903|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591904|NCT00972725|E2|Reported Event|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
591905|NCT00972725|E1|Reported Event|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
591906|NCT00972738|B4|Baseline|Total|Total of all reporting groups
591907|NCT00972738|B3|Baseline|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591908|NCT00972738|B2|Baseline|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591909|NCT00972738|B1|Baseline|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591962|NCT00972816|P4|Participant Flow|7.5_(100)MF59|7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
591910|NCT00972738|P3|Participant Flow|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591911|NCT00972738|P2|Participant Flow|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591912|NCT00972738|P1|Participant Flow|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591913|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591914|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591915|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591916|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591917|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591918|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591919|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591920|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591921|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591922|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591923|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591924|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591925|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591926|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591927|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591928|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591929|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591930|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
592003|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
591931|NCT00972738|E3|Reported Event|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591932|NCT00972738|E2|Reported Event|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591933|NCT00972738|E1|Reported Event|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
591934|NCT00972777|B3|Baseline|Total|Total of all reporting groups
591935|NCT00972777|B2|Baseline|Vehicle|Vehicle of besifloxacin ophthalmic suspension
591936|NCT00972777|B1|Baseline|Besifloxacin|0.6% ophthalmic suspension
591937|NCT00972777|P2|Participant Flow|Vehicle|Vehicle of besifloxacin ophthalmic suspension
591938|NCT00972777|P1|Participant Flow|Besifloxacin|0.6% ophthalmic suspension
591939|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
591940|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
591941|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
591942|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
591943|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
591944|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
591945|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
591946|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
591947|NCT00972777|E2|Reported Event|Vehicle|Vehicle of besifloxacin ophthalmic suspension
591948|NCT00972777|E1|Reported Event|Besifloxacin|0.6% ophthalmic suspension
591949|NCT00972816|B9|Baseline|Total|Total of all reporting groups
591950|NCT00972816|B8|Baseline|30 Without MF59|1 dose of 30 µg A/H1N1
591951|NCT00972816|B7|Baseline|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
591952|NCT00972816|B6|Baseline|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
591953|NCT00972816|B5|Baseline|15 Without MF59|1 dose of 15 µg A/H1N1
591954|NCT00972816|B4|Baseline|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
591955|NCT00972816|B3|Baseline|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
591956|NCT00972816|B2|Baseline|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
591957|NCT00972816|B1|Baseline|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
591958|NCT00972816|P8|Participant Flow|30_(0) MF59|30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
591959|NCT00972816|P7|Participant Flow|15_(100) MF59|15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
591960|NCT00972816|P6|Participant Flow|15_(50) MF59|15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
591961|NCT00972816|P5|Participant Flow|15_(0) MF59|15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
601694|NCT00999141|O8|Outcome|SoC Side - Day 14|
591964|NCT00972816|P2|Participant Flow|7.5_(0) MF59|7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
591965|NCT00972816|P1|Participant Flow|3.75_(50) MF59|3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
591966|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
591967|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
591968|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
591969|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
591970|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
591971|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
591972|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
591973|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
591974|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
591975|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
591976|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
591977|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
591978|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
591979|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
591980|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
591981|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
591982|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
591983|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
591984|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
591985|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
591986|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
591987|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
591988|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
591989|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
591990|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
591991|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
591992|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
591993|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
591994|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
591995|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
591996|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
591997|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
591998|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
591999|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
592000|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
592001|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
592005|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
592006|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
592007|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
592008|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
592009|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
592010|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
592011|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
592012|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
592013|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
592014|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
592015|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
592016|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
592017|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
592018|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
592019|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
592020|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
592021|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
592022|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
592023|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
592024|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
592025|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
592026|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
592027|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
592028|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
592029|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
592030|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
592031|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
592032|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
592033|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
592034|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
592035|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
592036|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
592037|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
592038|NCT00972816|E8|Reported Event|30 Without MF59|1 dose of 30 µg A/H1N1
592039|NCT00972816|E7|Reported Event|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
592040|NCT00972816|E6|Reported Event|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
592041|NCT00972816|E5|Reported Event|15 Without MF59|1 dose of 15 µg A/H1N1
592042|NCT00972816|E4|Reported Event|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
592043|NCT00972816|E3|Reported Event|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
592044|NCT00972816|E2|Reported Event|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
592045|NCT00972816|E1|Reported Event|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
592046|NCT00972959|B1|Baseline|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592047|NCT00972959|P1|Participant Flow|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592048|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592049|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592102|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592050|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592051|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592052|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592053|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592074|NCT00973349|B4|Baseline|7.5_(100)MF59 (18 to 64)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
592075|NCT00973349|B3|Baseline|7.5_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
592054|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592055|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592056|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592057|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592058|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592059|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592060|NCT00972959|E1|Reported Event|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.
Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.
Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months
Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
592061|NCT00973349|B17|Baseline|Total|Total of all reporting groups
592062|NCT00973349|B16|Baseline|30 w/o MF59 (≥ 65)|1 dose of 30 µg A/H1N1 in subjects ≥ 65 years of age
592063|NCT00973349|B15|Baseline|15_(100)MF59 (≥ 65)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
592064|NCT00973349|B14|Baseline|15_(50)MF59 (≥ 65)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
592065|NCT00973349|B13|Baseline|15 w/o MF59 (≥ 65)|1 dose of 15 µg A/H1N1 in subjects ≥ 65 years of age
592066|NCT00973349|B12|Baseline|7.5_(100)MF59 (≥ 65)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
592067|NCT00973349|B11|Baseline|7.5_(50)MF59 (≥ 65)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
592068|NCT00973349|B10|Baseline|7.5 w/o MF59 (≥ 65)|1 dose of 7.5 µg A/H1N1 in subjects ≥ 65 years of age
592069|NCT00973349|B9|Baseline|3.75_(50)MF59 (≥ 65 )|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects ≥ 65 years of age
592070|NCT00973349|B8|Baseline|30 w/o MF59 (18 to 64)|1 dose of 30 µg A/H1N1 in subjects 18 to 64 years of age
592071|NCT00973349|B7|Baseline|15_(100)MF59 (18 to 64)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen
592072|NCT00973349|B6|Baseline|15_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects 18 to 64 years of age
592073|NCT00973349|B5|Baseline|15 w/o MF59 (18 to 64)|1 dose of 15 µg A/H1N1 in subjects 18 to 64 years of age
601695|NCT00999141|O7|Outcome|FS VH S/D 4 S-apr Side - Day 14|
592076|NCT00973349|B2|Baseline|7.5 w/o MF59 (18 to 64)|1 dose of 7.5 µg A/H1N1 in subjects 18 to 64 years of age
592077|NCT00973349|B1|Baseline|3.75_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects 18 to 64 years of age
592078|NCT00973349|P16|Participant Flow|30 w/o MF59(≥ 65 Years)|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592079|NCT00973349|P15|Participant Flow|15_(100)MF59 (≥ 65 Years)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592080|NCT00973349|P14|Participant Flow|15_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592081|NCT00973349|P13|Participant Flow|15 w/o MF59 (≥ 65 Years)|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592082|NCT00973349|P12|Participant Flow|7.5_(100)MF59 (≥ 65 Years)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592083|NCT00973349|P11|Participant Flow|7.5_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592084|NCT00973349|P10|Participant Flow|7.5 w/o MF59 (≥ 65 Years)|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592085|NCT00973349|P9|Participant Flow|3.75_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592086|NCT00973349|P8|Participant Flow|30 w/o MF59(18-64 Years)|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592087|NCT00973349|P7|Participant Flow|15_(100)MF59 (18-64 Years)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592088|NCT00973349|P6|Participant Flow|15_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592089|NCT00973349|P5|Participant Flow|15 w/o MF59 (18-64 Years)|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592090|NCT00973349|P4|Participant Flow|7.5_(100)MF59 (18-64 Years)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592091|NCT00973349|P3|Participant Flow|7.5_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592092|NCT00973349|P2|Participant Flow|7.5 w/o MF59 (18-64 Years)|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592093|NCT00973349|P1|Participant Flow|3.75_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592094|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592095|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592096|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592097|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592098|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592099|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592100|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592101|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592103|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592104|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592105|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592106|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592107|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592108|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592109|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592110|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592111|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592112|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592113|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592114|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592115|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592116|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592117|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592118|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592119|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592120|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592121|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592122|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592123|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592124|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592125|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592126|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592127|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592128|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592129|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592130|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592131|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592132|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592133|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592134|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592135|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592136|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592137|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592138|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592139|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592140|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592141|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592142|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592143|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592144|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592145|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592146|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592147|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592148|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592149|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592150|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592151|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592152|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592153|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592154|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592155|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592156|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592157|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592158|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592159|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592160|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592161|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592162|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592163|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592164|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592165|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592166|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
592167|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592168|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
592169|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
592170|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592171|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
592172|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
592173|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
592174|NCT00973349|E16|Reported Event|30 w/o MF59 (≥65 Yrs)|1 dose of 30 µg A/H1N1
592175|NCT00973349|E15|Reported Event|15_(100)MF59 (≥65 Yrs)|100% of MF59 with 15 µg A/H1N1 antigen
592176|NCT00973349|E14|Reported Event|15_(50)MF59 (≥65 Yrs)|50% of MF59 with 15 µg A/H1N1 antigen
592177|NCT00973349|E13|Reported Event|15 w/o MF59 (≥ 65 Yrs)|1 dose of 15 µg A/H1N1
592178|NCT00973349|E12|Reported Event|7.5_(100)MF59 (≥65 Yrs)|100% of MF59 with 7.5 µg A/H1N1 antigen
592179|NCT00973349|E11|Reported Event|7.5_(50)MF59 (≥65 Yrs)|50% of MF59 with 7.5 µg A/H1N1 antigen
592180|NCT00973349|E10|Reported Event|7.5 w/o MF59 (≥65 Yrs)|1 dose of 7.5 µg A/H1N1
601696|NCT00999141|O6|Outcome|SoC Side - Day 7|
592181|NCT00973349|E9|Reported Event|3.75_(50)MF59 (Above 65 Yrs)|50% of MF59 with the lowest amount of A/H1N1 antigen
592182|NCT00973349|E8|Reported Event|30 w/o MF59|1 dose of 30 µg A/H1N1
592183|NCT00973349|E7|Reported Event|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
592184|NCT00973349|E6|Reported Event|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
592185|NCT00973349|E5|Reported Event|15 w/o MF59|1 dose of 15 µg A/H1N1
592186|NCT00973349|E4|Reported Event|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
592187|NCT00973349|E3|Reported Event|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
592188|NCT00973349|E2|Reported Event|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1
592189|NCT00973349|E1|Reported Event|3.75_(50)MF59|50% of MF59 with the lowest amount of A/H1N1 antigen
592190|NCT00973362|B3|Baseline|Total|Total of all reporting groups
592191|NCT00973362|B2|Baseline|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
592192|NCT00973362|B1|Baseline|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
592193|NCT00973362|P2|Participant Flow|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
There is no follow-up period for the ASC-US Arm of the study, only for the Adjunct ARM has a three (3) year follow-up period."
592232|NCT00958919|P1|Participant Flow|Normal Saline First, Then Naloxone|Intravenous saline (25 ml) in first intervention period and intravenous Naloxone (10mg/25 ml) in second intervention period.
592233|NCT00958919|O2|Outcome|End of Resistance Load Breathing|End of Resistance Load Breathing post-infusion of Normal Saline (25 ml)
592234|NCT00958919|O1|Outcome|Baseline|Pre-infusion of Normal Saline (25 ml)
592194|NCT00973362|P1|Participant Flow|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
592195|NCT00973362|O1|Outcome|FDA-Approved HPV DNA Test|FDA-Approved HPV DNA Test as Comparator
592196|NCT00973362|O2|Outcome|FDA-Approved HPV DNA Test|FDA-Approved HPV DNA Test as Comparator
592197|NCT00973362|O1|Outcome|APTIMA HPV Assay|APTIMA HPV Assay Performed on the Tigris System
592198|NCT00973362|O1|Outcome|FDA-Approved DNA Test|A FDA-Approved HPV DNA Test is the comparator assay,
592199|NCT00973362|O1|Outcome|APTIMA HPV Assay|"The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
592200|NCT00973362|E2|Reported Event|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
592215|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
592270|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592271|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592201|NCT00973362|E1|Reported Event|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
592202|NCT00973479|B3|Baseline|Total|Total of all reporting groups
592203|NCT00973479|B2|Baseline|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
592204|NCT00973479|B1|Baseline|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
592205|NCT00973479|P2|Participant Flow|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
592206|NCT00973479|P1|Participant Flow|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
592207|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
592235|NCT00958919|O2|Outcome|End of Resistance Load Breathing|End of Resistance Load Breathing post-infusion of Naloxone (10 mg/25 ml)
592208|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
592209|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
592210|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
592211|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
592212|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
592213|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
592214|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
592260|NCT00959049|O2|Outcome|Fluzone Cohort B|Age 3 to < 9 years
592261|NCT00959049|O1|Outcome|Afluria Cohort B|Age 3 to < 9 years
592262|NCT00959049|O2|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
592263|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
592216|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
592217|NCT00973479|E4|Reported Event|Combined Golimumab|Participants in the reporting groups: Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16, Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24, and Golimumab 2 mg/kg + MTX.
592218|NCT00973479|E3|Reported Event|Golimumab 2 mg/kg + MTX|Participants were assigned to Golimumab 2 mg/kg + MTX and received at least one 2 mg/kg Golimumab. The follow-up period for this treatment group begins with the first dose of Golimumab 2 mg/kg. Participants may have missed one or more Golimumab doses.
592219|NCT00973479|E2|Reported Event|Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24|Participants received placebo only through Week 24 or subjects who received first placebo and later inadvertently received Golimumab after Week 16 through Week 24. The follow-up period for this treatment group begins once a participants switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
592220|NCT00973479|E1|Reported Event|Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16|Participants received placebo only through Week 16 and met early escape criteria or subjects who received first placebo and later inadvertently received Golimumab prior or at Week 16. The follow-up period for this treatment group begins once a participant switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
592221|NCT00973622|B3|Baseline|Total|Total of all reporting groups
592222|NCT00973622|B2|Baseline|Nonsmokers|
592223|NCT00973622|B1|Baseline|Smokers|
592224|NCT00973622|P2|Participant Flow|Non-smokers|Healthy adult non-smokers who were between the ages of aged 19-55 years.
592225|NCT00973622|P1|Participant Flow|Smokers|Smokers were healthy adults between the ages of 19 and 55 years who had no intention of quitting smoking before the end of the study.
592226|NCT00973622|O2|Outcome|Non-smokers|Healthy adult non-smokers aged 19-55
592227|NCT00973622|O1|Outcome|Smokers|Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
592228|NCT00973622|E2|Reported Event|Non-smokers|Healthy adult non-smokers aged 19-55
592229|NCT00973622|E1|Reported Event|Smokers|Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
592230|NCT00958919|B1|Baseline|Entire Study Population|Includes groups randomized to receive saline first and Naxolone first.
592231|NCT00958919|P2|Participant Flow|Naloxone First, Then Normal Saline|Intravenous Naloxone (10mg/25 ml)in first intervention period and intravenous saline (25 ml) in second intervention period.
592236|NCT00958919|O1|Outcome|Baseline|Pre-infusion of Naloxone (10 mg/25 ml)
592237|NCT00958919|O2|Outcome|Naloxone|Intravenous Naloxone (10mg/25ml)given prior to start of Resistive Load Breathing
592238|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml) given prior to start of Resistive Load Breathing
592239|NCT00958919|O2|Outcome|Naloxone|Intravension Naloxone (10mg/25ml)
592240|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml)
592241|NCT00958919|O2|Outcome|Naloxone|Intravenous Naloxone (10mg/25ml)
592242|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml)
592243|NCT00958919|E2|Reported Event|Naloxone|10mg/25ml Intravenous
592244|NCT00958919|E1|Reported Event|Normal Saline|25 ml Intravenous
592245|NCT00959049|B7|Baseline|Total|Total of all reporting groups
592246|NCT00959049|B6|Baseline|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592247|NCT00959049|B5|Baseline|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592248|NCT00959049|B4|Baseline|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592249|NCT00959049|B3|Baseline|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592250|NCT00959049|B2|Baseline|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592251|NCT00959049|B1|Baseline|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
592252|NCT00959049|P6|Participant Flow|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592253|NCT00959049|P5|Participant Flow|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592254|NCT00959049|P4|Participant Flow|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592255|NCT00959049|P3|Participant Flow|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592256|NCT00959049|P2|Participant Flow|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592257|NCT00959049|P1|Participant Flow|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
592258|NCT00959049|O2|Outcome|Fluzone Cohort C|Age 9 to < 18 years
592259|NCT00959049|O1|Outcome|Afluria Cohort C|Age 9 to < 18 years
592272|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592273|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592274|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592275|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
592276|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592277|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592278|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592279|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592280|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592281|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
592282|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592283|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592284|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592285|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592286|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592287|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
592288|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592289|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592290|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592291|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592292|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592293|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
592294|NCT00959049|O2|Outcome|Fluzone Cohort C|Age 9 to < 18 years
592295|NCT00959049|O1|Outcome|Afluria Cohort C|Age 9 to < 18 years
592296|NCT00959049|O2|Outcome|Fluzone Cohort B|Age 3 to < 9 years
592297|NCT00959049|O1|Outcome|Afluria Cohort B|Age 3 to < 9 years
592298|NCT00959049|O2|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
592299|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
592300|NCT00959049|E6|Reported Event|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592301|NCT00959049|E5|Reported Event|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592302|NCT00959049|E4|Reported Event|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
592303|NCT00959049|E3|Reported Event|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592304|NCT00959049|E2|Reported Event|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
592305|NCT00959049|E1|Reported Event|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
592306|NCT00959192|B5|Baseline|Total|Total of all reporting groups
592307|NCT00959192|B4|Baseline|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592308|NCT00959192|B3|Baseline|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592309|NCT00959192|B2|Baseline|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592310|NCT00959192|B1|Baseline|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592311|NCT00959192|P4|Participant Flow|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592312|NCT00959192|P3|Participant Flow|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592313|NCT00959192|P2|Participant Flow|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592314|NCT00959192|P1|Participant Flow|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592315|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592316|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592317|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592318|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
592319|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592320|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592321|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592322|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
592323|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592324|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592325|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592326|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
592327|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592328|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592329|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592330|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592331|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592332|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592426|NCT00959764|O3|Outcome|Placebo|Patients who were provided nasal and oral placebo medication in a blinded fashion
595193|NCT00979628|B4|Baseline|Total|Total of all reporting groups
592333|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592334|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
592335|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592336|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592337|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592338|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592339|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592340|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592341|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592342|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
592343|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592344|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592345|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592346|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
592347|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592348|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592370|NCT00959699|B3|Baseline|Total|Total of all reporting groups
592349|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592350|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592351|NCT00959192|E4|Reported Event|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592352|NCT00959192|E3|Reported Event|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592353|NCT00959192|E2|Reported Event|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592354|NCT00959192|E1|Reported Event|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
592355|NCT00959374|B1|Baseline|V-loc and Monocryl|All randomized subjects
592356|NCT00959374|P1|Participant Flow|V-loc and Monocryl|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
592357|NCT00959374|O2|Outcome|3-0 Monocryl Sutures|Each Subject served as their own control and was randomized to which side of the body received the control sutures. The control side included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl(TM)sutures, spaced no further than 2cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl(TM) sutures.
592358|NCT00959374|O1|Outcome|V-Loc 180 / 90 Wound Closure Device|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
592359|NCT00959374|O2|Outcome|3-0 Monocryl Sutures|Each Subject served as their own control and was randomized to which side of the body received the control sutures. The control side included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl(TM)sutures, spaced no further than 2cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl(TM) sutures.
592427|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who were provided active nasal calcitonin and placebo oral medication in a blinded fashion.
592428|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who were provided active oral calcitonin and placebo nasal medication in a blinded fashion.
592429|NCT00959764|E3|Reported Event|Placebo|Patients who did not receive any active treatment
592360|NCT00959374|O1|Outcome|V-Loc 180 / 90 Wound Closure Device|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
592361|NCT00959374|E4|Reported Event|Non-protocol Incision or Systemic Events|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at either a non-protocol incision or were systemic in nature.
592362|NCT00959374|E3|Reported Event|Midline|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at midline incision and therefore not assigned to a treatment arm.
592363|NCT00959374|E2|Reported Event|Control - Monocryl 3-0|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
592364|NCT00959374|E1|Reported Event|V-Loc 180 / 90|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
592365|NCT00959647|B1|Baseline|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
592366|NCT00959647|P1|Participant Flow|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
592367|NCT00959647|O1|Outcome|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
592368|NCT00959647|O1|Outcome|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
592369|NCT00959647|E1|Reported Event|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
592371|NCT00959699|B2|Baseline|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
592372|NCT00959699|B1|Baseline|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
592373|NCT00959699|P2|Participant Flow|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
592374|NCT00959699|P1|Participant Flow|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
592375|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
592376|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
592377|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
592378|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
592379|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
595411|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
592380|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
592381|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
592382|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
592383|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
592384|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
592385|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
592386|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
592387|NCT00959699|E3|Reported Event|Boceprevir Crossover|(After Treatment Week 24) PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) plus boceprevir (800 mg, orally, 3 times per day) for up to 44 weeks with 24 weeks post-treatment follow-up.
592388|NCT00959699|E2|Reported Event|PegIFN-2b+RBV+Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
592389|NCT00959699|E1|Reported Event|PegIFN-2b+RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
592390|NCT00959751|B3|Baseline|Total|Total of all reporting groups
592391|NCT00959751|B2|Baseline|Placebo|3 x 0 mg capsules
592393|NCT00959751|P2|Participant Flow|NXN-188 600 mg|3 x 200 mg capsules, PRN
592394|NCT00959751|P1|Participant Flow|Placebo|3 x capsules, PRN
592395|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
592396|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
592397|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
592398|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
592399|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
592400|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
592401|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
592402|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
592403|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
592404|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
592405|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
592406|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
592407|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
592408|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
592409|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
592410|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
592411|NCT00959751|E2|Reported Event|Placebo|3 x 0 mg capsules, PRN
592412|NCT00959751|E1|Reported Event|NXN-188 600 mg|3 x 200 mg capsules, PRN
592413|NCT00959764|B4|Baseline|Total|Total of all reporting groups
592414|NCT00959764|B3|Baseline|Placebo|Patients who did not receive any active treatment
592415|NCT00959764|B2|Baseline|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
592416|NCT00959764|B1|Baseline|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
592417|NCT00959764|P3|Participant Flow|Placebo|Patients who did not receive any active treatment
592418|NCT00959764|P2|Participant Flow|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
592419|NCT00959764|P1|Participant Flow|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
592420|NCT00959764|O3|Outcome|Placebo|Patients who did not receive any active treatment
592421|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
592422|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
592423|NCT00959764|O3|Outcome|Placebo|Patients who did not receive any active treatment
592424|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
592425|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
593313|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
592430|NCT00959764|E2|Reported Event|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
592431|NCT00959764|E1|Reported Event|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
592432|NCT00959894|B1|Baseline|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592433|NCT00959894|P1|Participant Flow|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592434|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day
Truvada: Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592435|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day
Truvada: Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592436|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592437|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592438|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592439|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592440|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592441|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592442|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592443|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592444|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592445|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592446|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592447|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592448|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592449|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592483|NCT00959920|E1|Reported Event|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
592484|NCT00959946|B9|Baseline|Total|Total of all reporting groups
592450|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592451|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592452|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592453|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592454|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592455|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592456|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592457|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592458|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592459|NCT00959894|E1|Reported Event|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily
Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
592460|NCT00959907|B3|Baseline|Total|Total of all reporting groups
592461|NCT00959907|B2|Baseline|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
592462|NCT00959907|B1|Baseline|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
592463|NCT00959907|P2|Participant Flow|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
592464|NCT00959907|P1|Participant Flow|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
592465|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
592466|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
592467|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
592468|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
592469|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
592470|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
592471|NCT00959907|E2|Reported Event|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
592472|NCT00959907|E1|Reported Event|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
592473|NCT00959920|B3|Baseline|Total|Total of all reporting groups
592474|NCT00959920|B2|Baseline|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
592475|NCT00959920|B1|Baseline|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
592476|NCT00959920|P2|Participant Flow|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
592477|NCT00959920|P1|Participant Flow|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
592478|NCT00959920|O2|Outcome|Intermittent Straight Catheterization|"Intermittent straight catheterization will be performed as needed during labor.
Intermittent straight catheterization: intermittent straight catheterization will be performed on an as needed basis until time of delivery."
592479|NCT00959920|O1|Outcome|Indwelling Foley Catheter|"Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
Indwelling catheter: Indwelling bladder catheter will remain in place until time of delivery."
592480|NCT00959920|O2|Outcome|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
592481|NCT00959920|O1|Outcome|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
592482|NCT00959920|E2|Reported Event|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
595412|NCT00980174|O1|Outcome|Placebo|
592485|NCT00959946|B8|Baseline|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592486|NCT00959946|B7|Baseline|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592487|NCT00959946|B6|Baseline|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592488|NCT00959946|B5|Baseline|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592489|NCT00959946|B4|Baseline|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592490|NCT00959946|B3|Baseline|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592491|NCT00959946|B2|Baseline|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592492|NCT00959946|B1|Baseline|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
592493|NCT00959946|P8|Participant Flow|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592700|NCT00960154|P1|Participant Flow|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
592494|NCT00959946|P7|Participant Flow|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592495|NCT00959946|P6|Participant Flow|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592496|NCT00959946|P5|Participant Flow|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592497|NCT00959946|P4|Participant Flow|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592498|NCT00959946|P3|Participant Flow|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592499|NCT00959946|P2|Participant Flow|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592500|NCT00959946|P1|Participant Flow|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
592501|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
592502|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
592593|NCT00959985|E2|Reported Event|Group 1B|"Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592503|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
592504|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
592505|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
592506|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
592507|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
592508|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
592523|NCT00959946|O6|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592737|NCT00960206|E4|Reported Event|All Participants|All participants combined.
592509|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
592510|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
592511|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
592512|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
592513|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
592514|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
592515|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
592516|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
592517|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
592518|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
592519|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
592520|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
592521|NCT00959946|O8|Outcome|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592522|NCT00959946|O7|Outcome|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592608|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592524|NCT00959946|O5|Outcome|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592525|NCT00959946|O4|Outcome|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592526|NCT00959946|O3|Outcome|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592527|NCT00959946|O2|Outcome|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592528|NCT00959946|O1|Outcome|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
592529|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
592530|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
592531|NCT00959946|O8|Outcome|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592532|NCT00959946|O7|Outcome|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
593314|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
592533|NCT00959946|O6|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592534|NCT00959946|O5|Outcome|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592535|NCT00959946|O4|Outcome|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592536|NCT00959946|O3|Outcome|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592537|NCT00959946|O2|Outcome|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592538|NCT00959946|O1|Outcome|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
592539|NCT00959946|O3|Outcome|Bosutinib + Capecitabine 1000 mg/m^2|Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 1000 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592540|NCT00959946|O2|Outcome|Bosutinib + Capecitabine 750 mg/m^2|Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 750 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592541|NCT00959946|O1|Outcome|Bosutinib + Capecitabine 625 mg/m^2|Bosutinib 200 mg, or 300 mg, tablet administered orally once daily in a 21-day cycle. Capecitabine 625 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592542|NCT00959946|E8|Reported Event|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592543|NCT00959946|E7|Reported Event|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592544|NCT00959946|E6|Reported Event|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592545|NCT00959946|E5|Reported Event|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592546|NCT00959946|E4|Reported Event|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592547|NCT00959946|E3|Reported Event|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592548|NCT00959946|E2|Reported Event|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
592549|NCT00959946|E1|Reported Event|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
592550|NCT00959985|B5|Baseline|Total|Total of all reporting groups
592551|NCT00959985|B4|Baseline|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
592552|NCT00959985|B3|Baseline|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592553|NCT00959985|B2|Baseline|Group 1B|"Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592554|NCT00959985|B1|Baseline|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
592594|NCT00959985|E1|Reported Event|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
592595|NCT00960063|B4|Baseline|Total|Total of all reporting groups
592555|NCT00959985|P4|Participant Flow|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
592556|NCT00959985|P3|Participant Flow|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592557|NCT00959985|P2|Participant Flow|Group 1B|"Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592558|NCT00959985|P1|Participant Flow|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
592559|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
592560|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592561|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592562|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
592563|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
592564|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592565|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592566|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
592567|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
592568|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592569|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592570|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
592571|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
592572|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592573|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592574|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
592738|NCT00960206|E3|Reported Event|Control|Hips that received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
592575|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
592576|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592577|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592578|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
592579|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
592580|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592581|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592582|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
592583|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
592584|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592585|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592586|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
592587|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
592588|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592589|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592590|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
592591|NCT00959985|E4|Reported Event|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
Compression Sleeve: Worn for a minimum of 12 hours per day
Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
592592|NCT00959985|E3|Reported Event|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve
Compression Sleeve: Worn for a minimum of 12 hours per day"
592596|NCT00960063|B3|Baseline|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592597|NCT00960063|B2|Baseline|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592598|NCT00960063|B1|Baseline|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592599|NCT00960063|P3|Participant Flow|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592600|NCT00960063|P2|Participant Flow|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592601|NCT00960063|P1|Participant Flow|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592602|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592603|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592604|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592605|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592606|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592607|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
601697|NCT00999141|O5|Outcome|FS VH S/D 4 S-apr Side - Day 7|
592609|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592610|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592611|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592612|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592613|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592614|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592615|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592616|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592617|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592618|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592619|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592620|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592621|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
593315|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
592622|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592623|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592624|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592625|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592626|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592627|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592628|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592629|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592630|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592631|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592632|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592633|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592634|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592635|NCT00960063|E3|Reported Event|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592636|NCT00960063|E2|Reported Event|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592637|NCT00960063|E1|Reported Event|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
592638|NCT00960076|B3|Baseline|Total|Total of all reporting groups
592639|NCT00960076|B2|Baseline|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
592640|NCT00960076|B1|Baseline|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
592641|NCT00960076|P2|Participant Flow|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
592642|NCT00960076|P1|Participant Flow|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
592643|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
592644|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
592645|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
592646|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
592647|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
592648|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
592649|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
592650|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
592651|NCT00960076|E2|Reported Event|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
592652|NCT00960076|E1|Reported Event|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
592653|NCT00960115|B3|Baseline|Total|Total of all reporting groups
592654|NCT00960115|B2|Baseline|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
592655|NCT00960115|B1|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
592656|NCT00960115|P2|Participant Flow|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
592657|NCT00960115|P1|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram [mcg]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until progressive disease (PD) was documented.
592658|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
592659|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
592660|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
592661|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
592662|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
592699|NCT00960154|P2|Participant Flow|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
592663|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
592664|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
592665|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
592666|NCT00960115|E2|Reported Event|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
592667|NCT00960115|E1|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
592668|NCT00960141|B4|Baseline|Total|Total of all reporting groups
592669|NCT00960141|B3|Baseline|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
592670|NCT00960141|B2|Baseline|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
592671|NCT00960141|B1|Baseline|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
592672|NCT00960141|P3|Participant Flow|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
592673|NCT00960141|P2|Participant Flow|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
592674|NCT00960141|P1|Participant Flow|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
592675|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
592676|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
592677|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
592678|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
592679|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
592680|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
592681|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
592682|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
592683|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
592684|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
592685|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
592686|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
592687|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
592688|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
592689|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
592690|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
592691|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
592692|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
592693|NCT00960141|E3|Reported Event|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
592694|NCT00960141|E2|Reported Event|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
592695|NCT00960141|E1|Reported Event|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
592696|NCT00960154|B3|Baseline|Total|Total of all reporting groups
592697|NCT00960154|B2|Baseline|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
592698|NCT00960154|B1|Baseline|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
592701|NCT00960154|O2|Outcome|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
592702|NCT00960154|O1|Outcome|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
592703|NCT00960154|O2|Outcome|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
592704|NCT00960154|O1|Outcome|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
592705|NCT00960154|E2|Reported Event|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
592706|NCT00960154|E1|Reported Event|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
592707|NCT00960193|B1|Baseline|Colchicine Alone, Colchicine With Seville Orange Juice|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
592708|NCT00960193|P1|Participant Flow|Colchicine Alone, Colchicine With Seville Orange Juice|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
592709|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
592710|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
592711|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
592712|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
592713|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
592714|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
592715|NCT00960193|E3|Reported Event|Colchicine With Seville Orange Juice|On Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
592716|NCT00960193|E2|Reported Event|Seville Orange Juice Alone|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening.
592717|NCT00960193|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at after an overnight fast, followed by a washout period of 14 days.
592718|NCT00960206|B4|Baseline|Total|Total of all reporting groups
592719|NCT00960206|B3|Baseline|Control|Howmedica Osteonics Omnifit Series II Cup Inserts/Omnifit PSL Microstructured Shell
592720|NCT00960206|B2|Baseline|ABC System|Howmedica Osteonics Alumina Insert/either PSL Microstructured or Secur Fit HA PSL Shell
592721|NCT00960206|B1|Baseline|Trident System|Trident Ceramic Insert/Trident AD with PureFix HA Shell
592722|NCT00960206|P3|Participant Flow|Control|Hip received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
592723|NCT00960206|P2|Participant Flow|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
592724|NCT00960206|P1|Participant Flow|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
592725|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
592726|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
592727|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
592728|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
592729|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
592730|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
592731|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
592732|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
592733|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
592734|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
592735|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
592736|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
601698|NCT00999141|O4|Outcome|SoC Side - Day 3|
592739|NCT00960206|E2|Reported Event|ABC System|Hips that received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
592740|NCT00960206|E1|Reported Event|Trident® System|Hips that received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
592741|NCT00965718|B1|Baseline|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
592742|NCT00965718|P1|Participant Flow|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
592743|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
592744|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
592745|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
592746|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
592747|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
592748|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
592749|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
592750|NCT00965718|E1|Reported Event|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
592751|NCT00965731|B3|Baseline|Total|Total of all reporting groups
592752|NCT00965731|B2|Baseline|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592753|NCT00965731|B1|Baseline|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592754|NCT00965731|P2|Participant Flow|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592755|NCT00965731|P1|Participant Flow|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592756|NCT00965731|O1|Outcome|All Treated Participants (Phase 1)|All participants who received PF-02341066 (200 mg or 150 mg) administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592757|NCT00965731|O1|Outcome|All Treated Participants (Phase 1)|All participants who received PF-02341066 (200 mg or 150 mg) administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592758|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
592759|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341033 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles
592760|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
592761|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
592762|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
592763|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
592764|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
592765|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
592766|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
592767|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
592768|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
592769|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
592770|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
592771|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
592772|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
592773|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
592774|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
592910|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592775|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
592776|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
592777|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
592778|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
592779|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
592780|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592781|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592782|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592783|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592784|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592785|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592786|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
593013|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
592787|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592788|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592789|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592790|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592791|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592792|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592793|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592794|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592795|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592911|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592796|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592797|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592798|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592799|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592800|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592801|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592802|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592803|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592804|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
593511|NCT00975637|E1|Reported Event|Broda 210 mg|AMG 827: 210 mg SC
592805|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592806|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592807|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592808|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592809|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592810|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592811|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592812|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles
592813|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
592814|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592859|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
592815|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592816|NCT00965731|E2|Reported Event|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592817|NCT00965731|E1|Reported Event|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
592818|NCT00965757|B3|Baseline|Total|Total of all reporting groups
592819|NCT00965757|B2|Baseline|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592820|NCT00965757|B1|Baseline|T-614 (Double-blind, 1-28 Weeks)|T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
592821|NCT00965757|P4|Participant Flow|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
592822|NCT00965757|P3|Participant Flow|T-614 (Extension, 29-52 Weeks)|T-614 was administered in combination with methotrexate. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
592823|NCT00965757|P2|Participant Flow|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592824|NCT00965757|P1|Participant Flow|T-614 (Double-blind, 1-28 Weeks)|T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
592825|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
593014|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
592826|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592827|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
592828|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
592829|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592830|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
592831|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
592832|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592833|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
592834|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
592835|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592836|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
601699|NCT00999141|O3|Outcome|FS VH S/D 4 S-apr Side - Day 3|
592837|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
592838|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592839|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
592840|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
592841|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592842|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
592843|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
592844|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592845|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
592872|NCT00965848|E2|Reported Event|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
592846|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
592847|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592848|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
592849|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
592850|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592851|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
592852|NCT00965757|E3|Reported Event|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
592853|NCT00965757|E2|Reported Event|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
592854|NCT00965757|E1|Reported Event|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
592855|NCT00965848|B1|Baseline|Entire Study Population|
592856|NCT00965848|P3|Participant Flow|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
592857|NCT00965848|P2|Participant Flow|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
592858|NCT00965848|P1|Participant Flow|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
592908|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592909|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592860|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
592861|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
592862|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
592863|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
592864|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
592865|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
592866|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
592867|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
592868|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
592869|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
592870|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
592871|NCT00965848|E3|Reported Event|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
592873|NCT00965848|E1|Reported Event|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
592874|NCT00973700|B6|Baseline|Total|Total of all reporting groups
592875|NCT00973700|B5|Baseline|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592876|NCT00973700|B4|Baseline|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592877|NCT00973700|B3|Baseline|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592878|NCT00973700|B2|Baseline|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
592879|NCT00973700|B1|Baseline|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
592880|NCT00973700|P5|Participant Flow|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592881|NCT00973700|P4|Participant Flow|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592882|NCT00973700|P3|Participant Flow|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592883|NCT00973700|P2|Participant Flow|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
592884|NCT00973700|P1|Participant Flow|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
592885|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592886|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592887|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592888|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
592889|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
592890|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592891|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592892|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592893|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592894|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592895|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592896|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592897|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592898|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592899|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
592900|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
592901|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592902|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592903|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592904|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
592905|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
592906|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592907|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
601700|NCT00999141|O2|Outcome|SoC Side - Day 1|
592912|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
592913|NCT00973700|O4|Outcome|15_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
592914|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
592915|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; two doses on day 1
592916|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
592917|NCT00973700|O1|Outcome|15_1_22|A/H1N1 on study days 1 and 22
592918|NCT00973700|O1|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592919|NCT00973700|E11|Reported Event|2x15_1_22 (3 to <9 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592920|NCT00973700|E10|Reported Event|15_1_22 (3 to <9 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592921|NCT00973700|E9|Reported Event|7.5adj_1_22 (3 to <9 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592922|NCT00973700|E8|Reported Event|2x15_1_22 (9 to 17 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592923|NCT00973700|E7|Reported Event|15_1_22 (9 to 17 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592924|NCT00973700|E6|Reported Event|7.5adj_1_22 (9 to 17 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592925|NCT00973700|E5|Reported Event|2x15_1_22 (18 to 64 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
592926|NCT00973700|E4|Reported Event|15_1_22 (18 to 64 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
592927|NCT00973700|E3|Reported Event|7.5adj_1_22 (18-64 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
592928|NCT00973700|E2|Reported Event|7.5adj_1_8 (18 to 64 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
592929|NCT00973700|E1|Reported Event|2x7.5adj (18 to 64 Yrs)|A/H1N1 7.5 mcg with MF59; two doses on day 1
592930|NCT00973739|B1|Baseline|Lapatinib|Lapatinib will be administered
592931|NCT00973739|P1|Participant Flow|Lapatinib|Lapatinib will be administered
592932|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:
Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily
Adults (18 years of age or older): 1,500 mg PO once daily
Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
592933|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:
Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily
Adults (18 years of age or older): 1,500 mg PO once daily
Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
592976|NCT00974974|O1|Outcome|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
593512|NCT00975689|B3|Baseline|Total|Total of all reporting groups
592934|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:
Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily
Adults (18 years of age or older): 1,500 mg PO once daily
Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
592935|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:
Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily
Adults (18 years of age or older): 1,500 mg PO once daily
Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
592936|NCT00973739|E1|Reported Event|Lapatinib|Lapatinib will be administered
592937|NCT00973752|B1|Baseline|Experimental|"All patients treated on same arm
Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.
Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy
PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
Cytarabine: Intrathecally during Induction and CNS therapy
Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy
Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
Clofarabine: Intravenously during Consolidation 1 Therapy
6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
592938|NCT00973752|P1|Participant Flow|Experimental|"All patients treated on same arm
Prednisone: Orally during Induction, Consolidation 1, CNS (central nervous system), Consolidation 2, and Continuation therapy.
Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy
PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
Cytarabine: Intrathecally during Induction and CNS therapy
Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy
Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
Clofarabine: Intravenously during Consolidation 1 Therapy
6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
592939|NCT00973752|O1|Outcome|Experimental|"All patients treated on same arm
Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.
Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy
PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
Cytarabine: Intrathecally during Induction and CNS therapy
Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy
Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
Clofarabine: Intravenously during Consolidation 1 Therapy
6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
592940|NCT00973752|E1|Reported Event|Experimental|"All patients treated on same arm
Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.
Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy
PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
Cytarabine: Intrathecally during Induction and CNS therapy
Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy
Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
Clofarabine: Intravenously during Consolidation 1 Therapy
6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
592941|NCT00973765|B3|Baseline|Total|Total of all reporting groups
592942|NCT00973765|B2|Baseline|Placebo|Matched placebo 2 pills po BID x 7 days
592943|NCT00973765|B1|Baseline|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
592944|NCT00973765|P2|Participant Flow|Placebo|Matched placebo 2 pills po BID x 7 days
592945|NCT00973765|P1|Participant Flow|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
592946|NCT00973765|O2|Outcome|Placebo|Matched placebo 2 pills po BID x 7 days
592947|NCT00973765|O1|Outcome|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
592948|NCT00973765|E2|Reported Event|Placebo|Matched placebo 2 pills po BID x 7 days
592949|NCT00973765|E1|Reported Event|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
592950|NCT00973921|B1|Baseline|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
592951|NCT00973921|P1|Participant Flow|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
592952|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
592953|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
592954|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
592955|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
592977|NCT00974974|E2|Reported Event|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
592978|NCT00974974|E1|Reported Event|IPX066|Investigational product IPX066
592979|NCT00975000|B3|Baseline|Total|Total of all reporting groups
592956|NCT00973921|E1|Reported Event|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
592957|NCT00974818|B3|Baseline|Total|Total of all reporting groups
592958|NCT00974818|B2|Baseline|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
592959|NCT00974818|B1|Baseline|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
592960|NCT00974818|P2|Participant Flow|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
592961|NCT00974818|P1|Participant Flow|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
592962|NCT00974818|O2|Outcome|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
592963|NCT00974818|O1|Outcome|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
592997|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
592998|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
592964|NCT00974818|E2|Reported Event|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
592965|NCT00974818|E1|Reported Event|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
592966|NCT00974974|B3|Baseline|Total|Total of all reporting groups
592967|NCT00974974|B2|Baseline|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
592968|NCT00974974|B1|Baseline|IPX066|Investigational product IPX066
592969|NCT00974974|P2|Participant Flow|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
592970|NCT00974974|P1|Participant Flow|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
592971|NCT00974974|O2|Outcome|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
592972|NCT00974974|O1|Outcome|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
592973|NCT00974974|O2|Outcome|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
592974|NCT00974974|O1|Outcome|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
592975|NCT00974974|O2|Outcome|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
592980|NCT00975000|B2|Baseline|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
592981|NCT00975000|B1|Baseline|Placebo|Participants received placebo orally once daily for 52 weeks.
592982|NCT00975000|P2|Participant Flow|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parathyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.
592983|NCT00975000|P1|Participant Flow|Placebo|Participants received placebo orally once daily for 52 weeks.
592984|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
592985|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
592986|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
592987|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
592988|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
592989|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
592990|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
592991|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
592992|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
592993|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
592994|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
592995|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
592996|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
592999|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
593000|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
593001|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
593002|NCT00975000|E2|Reported Event|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
593003|NCT00975000|E1|Reported Event|Placebo|Participants received placebo orally once daily for 52 weeks.
593004|NCT00975130|B1|Baseline|GLM50-SC|Participants received 50 mg of golimumab subcutaneously once monthly for a period of 6 months. 3280 enrolled participants were included in the Efficacy-Evaluable population; baseline characteristics are presented for this population.
593005|NCT00975130|P3|Participant Flow|SC-GLM50|Participants achieving good or moderate response but not in remission at the end of Study Part 1, received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
593006|NCT00975130|P2|Participant Flow|Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg|Participants achieving good or moderate response but not in remission at the conclusion of Study Part 1 received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab at a dose of 50 mg once monthly.
593007|NCT00975130|P1|Participant Flow|Golimumab 50 mg Subcutaneous (GLM50-SC)|Participants received GLM50-SC once monthly for a period of 6 months in Study Part 1.
593008|NCT00975130|O2|Outcome|SC-GLM50|Participants received SC GLM at a dose of 50 mg once monthly.
593009|NCT00975130|O1|Outcome|IV-GLM 2 mg/kg + SC GLM 50 mg|Participants received IV GLM at a dose of 2 mg/kg until remission is achieved at which time they were switched to SC GLM at a dose of 50 mg once monthly.
593010|NCT00975130|O2|Outcome|SC-GLM50|Participants received SC GLM at a dose of 50 mg once monthly.
593011|NCT00975130|O1|Outcome|IV-GLM 2 mg/kg + SC GLM 50 mg|"Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched to subcutaneous golimumab
at a dose of 50 mg once monthly."
593012|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
595413|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
593015|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593016|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593017|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593018|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593019|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593020|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593021|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593022|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593023|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593024|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593025|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593026|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593027|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593028|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
593029|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593030|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593031|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593032|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593033|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593034|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593035|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593036|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593037|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593038|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593039|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593040|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593041|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593042|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593043|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593044|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly.
593045|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
593046|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
593047|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593048|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593049|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593050|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593051|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593052|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593053|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593054|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593055|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593056|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593057|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593058|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593059|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593060|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593061|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593062|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593063|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593064|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593065|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593066|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593067|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593068|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593069|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593070|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593071|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593072|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593073|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593074|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593075|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593076|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593077|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593078|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593079|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593080|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593081|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593082|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593083|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593084|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593085|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593086|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593711|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
593087|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593088|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593089|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593090|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593091|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593092|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593093|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593094|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593095|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593096|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593097|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593098|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593099|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593100|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593101|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593102|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593103|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593104|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593105|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593106|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593107|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593108|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593308|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
593109|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593110|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593111|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593112|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593113|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593114|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593115|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593116|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593117|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593118|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593119|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593120|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593121|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593122|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593123|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593124|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593125|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593126|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593127|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593128|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593129|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593130|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593131|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593132|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593133|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593134|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593135|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593136|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593137|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593138|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593139|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593140|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593141|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593142|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593143|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593144|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593145|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593146|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593147|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593148|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593149|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593150|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593151|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593152|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593153|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593154|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593155|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
595414|NCT00980174|O1|Outcome|Placebo|
593156|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593157|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593158|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593159|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593160|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593161|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593162|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593163|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593164|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593165|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593166|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593167|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593168|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593169|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593170|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593171|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593172|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593173|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593174|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593175|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593176|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593177|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593178|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593179|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593180|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593181|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
593182|NCT00975130|O2|Outcome|SC-GLM50|Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
593183|NCT00975130|O1|Outcome|IV-GLM2/SC-GLM50|Intravenous golimumab 2 mg/kg followed by subcutaneous golimumab 50 mg once monthly.
593184|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly.
593185|NCT00975130|E3|Reported Event|SC-GLM50|Participants received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
593186|NCT00975130|E2|Reported Event|Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg|"Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab
at a dose of 50 mg once monthly."
593187|NCT00975130|E1|Reported Event|Golimumab 50 mg Subcutaneous (GLM50-SC)|Participants received GLM50-SC once monthly for a period of 6 months.
593188|NCT00975143|B3|Baseline|Total|Total of all reporting groups
593189|NCT00975143|B2|Baseline|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
593190|NCT00975143|B1|Baseline|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
593191|NCT00975143|P2|Participant Flow|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
593192|NCT00975143|P1|Participant Flow|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
593193|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
593194|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
593195|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
595415|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
593196|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
593197|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
593198|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
593199|NCT00975143|E2|Reported Event|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
593200|NCT00975143|E1|Reported Event|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
593201|NCT00975156|B3|Baseline|Total|Total of all reporting groups
593202|NCT00975156|B2|Baseline|Standard of Care|Conventional physical therapy
593203|NCT00975156|B1|Baseline|Lokomat Intervention|
593204|NCT00975156|P2|Participant Flow|Standard of Care|Conventional physical therapy
593205|NCT00975156|P1|Participant Flow|Lokomat Intervention|
593206|NCT00975156|O3|Outcome|All Participants 6MWD Outcome|Baseline, Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
593207|NCT00975156|O2|Outcome|Standard of Care 6MWD Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
593208|NCT00975156|O1|Outcome|Lokomat Intervention 6 Minute Walking Distance (6MWD) Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
593209|NCT00975156|O3|Outcome|All Participants 10mWT Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
593210|NCT00975156|O2|Outcome|Standard of Care 10mWT Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
593211|NCT00975156|O1|Outcome|Lokomat Intervention 10-meter Walking Test (10mWT) Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
593212|NCT00975156|E2|Reported Event|Standard of Care|Conventional physical therapy
593213|NCT00975156|E1|Reported Event|Lokomat Intervention|Robotic-assisted gait therapy
593214|NCT00975195|B3|Baseline|Total|Total of all reporting groups
593353|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593354|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593215|NCT00975195|B2|Baseline|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593216|NCT00975195|B1|Baseline|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593217|NCT00975195|P2|Participant Flow|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593218|NCT00975195|P1|Participant Flow|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593219|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593220|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593221|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
595416|NCT00980174|O1|Outcome|Placebo|
593222|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593223|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593224|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593225|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593226|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593227|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593228|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593229|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593355|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593712|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
593230|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593231|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593232|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593233|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593234|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593235|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593236|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593309|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
595417|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
593237|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593238|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593239|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593240|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593241|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593242|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593243|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593244|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593260|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593713|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
593245|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593246|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593247|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593248|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593249|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593250|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593310|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
593311|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
593312|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
595418|NCT00980174|O1|Outcome|Placebo|
593251|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593252|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593253|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593254|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593255|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593256|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593257|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593258|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593259|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593351|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593432|NCT00975481|E6|Reported Event|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593261|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593262|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593263|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593264|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593265|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593266|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593267|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593268|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593269|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593270|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593271|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593272|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593273|NCT00975195|E2|Reported Event|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
593274|NCT00975195|E1|Reported Event|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
593275|NCT00975221|B3|Baseline|Total|Total of all reporting groups
593276|NCT00975221|B2|Baseline|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593579|NCT00975923|P2|Participant Flow|Tool Kit Group|One group of hospitals is allocated randomly to the Tool Kit Group
593277|NCT00975221|B1|Baseline|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593278|NCT00975221|P2|Participant Flow|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593279|NCT00975221|P1|Participant Flow|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593280|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593281|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593282|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593283|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593284|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593285|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593286|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593287|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593288|NCT00975221|E4|Reported Event|Open-label Phase: Previous Cinacalcet|Participants who received cinacalcet during the double-blind phase continued to receive cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593289|NCT00975221|E3|Reported Event|Open-label Phase: Previous Placebo|Participants who received placebo during the double-blind phase (Weeks 1-28) then received cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
593352|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593714|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
593290|NCT00975221|E2|Reported Event|Double-blind Phase: Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week double-blind dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the double-blind efficacy assessment phase.
593291|NCT00975221|E1|Reported Event|Double-blind Phase: Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase.
593292|NCT00975286|B3|Baseline|Total|Total of all reporting groups
593293|NCT00975286|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
593294|NCT00975286|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
593295|NCT00975286|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
593296|NCT00975286|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
593297|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
593298|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
593299|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
593300|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
593301|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
593302|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
593303|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
593304|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
593305|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
593306|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
593307|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
593316|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
593317|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
593318|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
593319|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
593320|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
593321|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
593322|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
593323|NCT00975286|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
593324|NCT00975286|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
593325|NCT00975416|B3|Baseline|Total|Total of all reporting groups
593326|NCT00975416|B2|Baseline|Inpatient Cocaine Placebo|"Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients
Intranasal Placebo given in the context of cognitive behavioral therapy"
593327|NCT00975416|B1|Baseline|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients
Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
593328|NCT00975416|P2|Participant Flow|Inpatient Cocaine Placebo|Placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Placebo given in the context of cognitive behavioral therapy
593329|NCT00975416|P1|Participant Flow|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients
Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
593330|NCT00975416|O2|Outcome|Inpatient Cocaine Placebo|"Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients
Intranasal placebo given in the context of cognitive behavioral therapy"
593331|NCT00975416|O1|Outcome|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients
Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
593332|NCT00975416|E3|Reported Event|Inpatient Cocaine|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients
Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
593333|NCT00975416|E2|Reported Event|Outpatient Cocaine|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent outpatients
Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
593334|NCT00975416|E1|Reported Event|Methadone|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to methadone dependent outpatients
Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
593335|NCT00975481|B1|Baseline|Entire Study Population|Includes participants randomized to receive placebo first, alprazolam 1 mg first, alprazolam 3 mg first, dimebon 20 mg first, dimebon 40 mg first and dimebon 60 mg first.
593336|NCT00975481|P6|Participant Flow|DIM 60 mg, PBO, DIM 40 mg, ALP 1mg, DIM 20 mg, ALP 3 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the fourth intervention group; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
593337|NCT00975481|P5|Participant Flow|DIM 40 mg, DIM 60 mg, DIM 20 mg, PBO, ALP 3 mg, ALP 1 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the fourth intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
593338|NCT00975481|P4|Participant Flow|DIM 20 mg, DIM 40 mg, ALP 3 mg, DIM 60 mg, ALP 1 mg, PBO|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the fourth intervention period; then alprazolam 1mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
593339|NCT00975481|P3|Participant Flow|ALP 3 mg, DIM 20 mg, ALP 1 mg, DIM 40 mg, PBO, DIM 60 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the first intervention period; followed by dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 40 mg tablets, placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the fourth interventional period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of 7 days was maintained between each dose.
593340|NCT00975481|P2|Participant Flow|ALP 1 mg, ALP 3 mg, PBO, DIM 20 mg, DIM 60 mg, DIM 40 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the first intervention period; followed by alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the fourth intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and dimebon 40 mg tablets, placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
593341|NCT00975481|P1|Participant Flow|PBO, ALP 1mg, DIM 60 mg, ALP 3 mg, DIM 40 mg, DIM 20 mg|Placebo (PBO) matched to 3 alprazolam (ALP) capsules and placebo matched to 3 dimebon (DIM) tablets on Day 1 in the first intervention period; followed by alprazolam 1 milligram (mg) capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in fourth intervention period; then dimebon 40 mg tablets and placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and dimebon 20 mg tablet, placebo matched to 2 dimebon tablets and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
593342|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593343|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593344|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593345|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593346|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593347|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593348|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593349|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593350|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
601701|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Day 1|
593356|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593357|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593358|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593359|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593360|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593361|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593362|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593363|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593364|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593365|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593366|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593367|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593368|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593369|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593370|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593371|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593372|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593373|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593374|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593375|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593376|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593377|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593378|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593379|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593380|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593381|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593382|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593383|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593384|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593385|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593386|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593387|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593388|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593389|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593390|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593391|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593392|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593393|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593394|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593395|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593396|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593397|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593398|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593399|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593400|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593401|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593402|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593403|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593404|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593405|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593406|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsule, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593407|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593408|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593409|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593410|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593411|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593412|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsule, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593413|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593414|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593415|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593416|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593417|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593418|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam tablets, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593419|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593420|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593421|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to 1 dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593422|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593423|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593424|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593425|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593426|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
593427|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593428|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593429|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593430|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593431|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593433|NCT00975481|E5|Reported Event|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593434|NCT00975481|E4|Reported Event|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
593435|NCT00975481|E3|Reported Event|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593436|NCT00975481|E2|Reported Event|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593437|NCT00975481|E1|Reported Event|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
593438|NCT00975507|B3|Baseline|Total|Total of all reporting groups
593439|NCT00975507|B2|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
593440|NCT00975507|B1|Baseline|ProQuad™ + Placebo Followed by ProQuad™|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
593441|NCT00975507|P2|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
593442|NCT00975507|P1|Participant Flow|ProQuad™ + Placebo Followed by ProQuad™|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
593443|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
593444|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
593445|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
593446|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
593447|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
593448|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
593449|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
593450|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
593451|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
593452|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
593453|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
593454|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
593455|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
593456|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
593457|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
593458|NCT00975507|E3|Reported Event|M-M-R™ II + VARIVAX™ (1 Injection)|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
593459|NCT00975507|E2|Reported Event|ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections)|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
593460|NCT00975507|E1|Reported Event|ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection)|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0.
593461|NCT00975585|B3|Baseline|Total|Total of all reporting groups
593462|NCT00975585|B2|Baseline|Lotrafilcon B|contact lens
593463|NCT00975585|B1|Baseline|Senofilcon A|contact lens
593464|NCT00975585|P2|Participant Flow|Lotrafilcon B|contact lens
593465|NCT00975585|P1|Participant Flow|Senofilcon A|contact lens
593466|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
593467|NCT00975585|O1|Outcome|Senofilcon A|contact lens
593468|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
593469|NCT00975585|O1|Outcome|Senofilcon A|contact lens
593470|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
593471|NCT00975585|O1|Outcome|Senofilcon A|contact lens
593472|NCT00975585|O2|Outcome|Lotrafilcon B at 4 Weeks|lotrafilcon B contact lens after four weeks of wear
593473|NCT00975585|O1|Outcome|Lotrafilcon B at 2 Weeks|lotrafilcon B contact lens after two weeks of wear
593474|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
593475|NCT00975585|O1|Outcome|Senofilcon A|contact lens
593476|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
593477|NCT00975585|O1|Outcome|Senofilcon A|contact lens
593478|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
593479|NCT00975585|O1|Outcome|Senofilcon A|contact lens
593480|NCT00975585|E2|Reported Event|Lotrafilcon B|contact lens
593481|NCT00975585|E1|Reported Event|Senofilcon A|contact lens
593533|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
593534|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
593482|NCT00975611|B1|Baseline|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
593483|NCT00975611|P1|Participant Flow|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized (N=6), or completed (N=5), to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all consented/screened subjects (N=22) were published and are reported here.
593484|NCT00975611|O1|Outcome|All Consented Subjects|
593485|NCT00975611|E1|Reported Event|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
593486|NCT00975637|B6|Baseline|Total|Total of all reporting groups
593487|NCT00975637|B5|Baseline|Broda 70 mg|AMG 827: 70 mg SC
593488|NCT00975637|B4|Baseline|Placebo|Placebo: Placebo SC
593489|NCT00975637|B3|Baseline|Broda 280 mg|AMG 827: 280 mg SC
593490|NCT00975637|B2|Baseline|Broda 140 mg|AMG 827: 140 mg SC
593491|NCT00975637|B1|Baseline|Broda 210 mg|AMG 827: 210 mg SC
593492|NCT00975637|P5|Participant Flow|70 mg|AMG 827: 70 mg SC
593493|NCT00975637|P4|Participant Flow|Placebo|Placebo: Placebo SC
593494|NCT00975637|P3|Participant Flow|280 mg|AMG 827: 280 mg SC
593495|NCT00975637|P2|Participant Flow|140 mg|AMG 827: 140 mg SC
593496|NCT00975637|P1|Participant Flow|210 mg|AMG 827: 210 mg SC
593497|NCT00975637|O5|Outcome|Broda 70 mg|AMG 827: 70 mg SC
593498|NCT00975637|O4|Outcome|Placebo|Placebo: Placebo SC
593499|NCT00975637|O3|Outcome|Broda 280 mg|AMG 827: 280 mg SC
593500|NCT00975637|O2|Outcome|Broda 140 mg|AMG 827: 140 mg SC
593501|NCT00975637|O1|Outcome|Broda 210 mg|AMG 827: 210 mg SC
593502|NCT00975637|O5|Outcome|Broda 70 mg|AMG 827: 70 mg SC
593503|NCT00975637|O4|Outcome|Placebo|Placebo: Placebo SC
593504|NCT00975637|O3|Outcome|Broda 280 mg|AMG 827: 280 mg SC
593505|NCT00975637|O2|Outcome|Broda 140 mg|AMG 827: 140 mg SC
593506|NCT00975637|O1|Outcome|Broda 210 mg|AMG 827: 210 mg SC
593507|NCT00975637|E5|Reported Event|Broda 70 mg|AMG 827: 70 mg SC
593508|NCT00975637|E4|Reported Event|Placebo|Placebo: Placebo SC
593509|NCT00975637|E3|Reported Event|Broda 280 mg|AMG 827: 280 mg SC
593510|NCT00975637|E2|Reported Event|Broda 140 mg|AMG 827: 140 mg SC
593513|NCT00975689|B2|Baseline|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
593514|NCT00975689|B1|Baseline|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
593515|NCT00975689|P2|Participant Flow|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
593516|NCT00975689|P1|Participant Flow|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
593517|NCT00975689|O2|Outcome|Placebo Phase|
593518|NCT00975689|O1|Outcome|NAC Phase|
593519|NCT00975689|E2|Reported Event|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
593520|NCT00975689|E1|Reported Event|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
593521|NCT00975715|B3|Baseline|Total|Total of all reporting groups
593522|NCT00975715|B2|Baseline|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
593523|NCT00975715|B1|Baseline|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
593524|NCT00975715|P2|Participant Flow|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
593525|NCT00975715|P1|Participant Flow|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
593526|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
593527|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
593528|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
593529|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
593530|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
593531|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
593532|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
593715|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
593535|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
593536|NCT00975715|E2|Reported Event|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
593537|NCT00975715|E1|Reported Event|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
593538|NCT00975780|B3|Baseline|Total|Total of all reporting groups
593539|NCT00975780|B2|Baseline|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
593540|NCT00975780|B1|Baseline|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
593541|NCT00975780|P2|Participant Flow|Enhanced Oral Care|Enhanced Oral Care : oral brushing plus oral chlorhexidine plus upright feeding positioning
593542|NCT00975780|P1|Participant Flow|Usual Care|"The usual oral care provided at the nursing home
Usual oral care : Usual oral care and feeding positioning"
593543|NCT00975780|O2|Outcome|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
593544|NCT00975780|O1|Outcome|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
593545|NCT00975780|O2|Outcome|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
593546|NCT00975780|O1|Outcome|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
593547|NCT00975780|E2|Reported Event|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
593548|NCT00975780|E1|Reported Event|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
593549|NCT00975806|B4|Baseline|Total|Total of all reporting groups
593550|NCT00975806|B3|Baseline|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593551|NCT00975806|B2|Baseline|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593552|NCT00975806|B1|Baseline|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg PO QD on Days 1 to 21 of each 21-day cycle
593553|NCT00975806|P3|Participant Flow|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593554|NCT00975806|P2|Participant Flow|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593555|NCT00975806|P1|Participant Flow|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
593556|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593557|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593558|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
593559|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593560|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593561|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
593562|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593563|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593564|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
593565|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593566|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593567|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
593568|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593569|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593570|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
593571|NCT00975806|O1|Outcome|Phase 2: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
593572|NCT00975806|O1|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
593573|NCT00975806|E3|Reported Event|Cohort G|Lenalidomide 15 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
593574|NCT00975806|E2|Reported Event|Cohort F|Lenalidomide 10 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
593575|NCT00975806|E1|Reported Event|Cohort A|Lenalidomide 10 mg QD and sunitinib 37.5 mg QD on Days 1-21 of each 21-day cycle
593576|NCT00975923|B3|Baseline|Total|Total of all reporting groups
593577|NCT00975923|B2|Baseline|Tool Kit Group|One group of hospitals is allocated randomly to the Tool Kit Group
593578|NCT00975923|B1|Baseline|Collaborative Group|One group of hospitals is randomly allocated to the Collaborative Group
593580|NCT00975923|P1|Participant Flow|Collaborative Group|One group of hospitals is randomly allocated to the Collaborative Group
593581|NCT00975923|O2|Outcome|Tool Kit Group|Hospitals allocated randomly to only a Tool Kit of clinical guidelines and aides for quality improvement
593582|NCT00975923|O1|Outcome|Collaborative Group|Hospitals randomly allocated to the Virtual Collaborative involving teleconferences and Tool Kit
593583|NCT00975923|O2|Outcome|Tool Kit Group|Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for conducting quality improvement
593584|NCT00975923|O1|Outcome|Collaborative Group|Hospitals randomly allocated to the Virtual Collaborative involving teleconferences and Tool Kit
593585|NCT00975923|E2|Reported Event|Tool Kit Group|Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for quality improvement
593586|NCT00975923|E1|Reported Event|Collaborative Group|Hospitals allocated randomly to the Collaborative Quality Improvement intervention with teleconferences and Tool Kit
593587|NCT00975975|B1|Baseline|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
593588|NCT00975975|P1|Participant Flow|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
593589|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
593590|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
593591|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
593592|NCT00975975|E1|Reported Event|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
593593|NCT00976027|B3|Baseline|Total|Total of all reporting groups
593594|NCT00976027|B2|Baseline|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
593595|NCT00976027|B1|Baseline|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
593596|NCT00976027|P2|Participant Flow|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
593597|NCT00976027|P1|Participant Flow|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
593598|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
593599|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
593600|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
593601|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
593602|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
593603|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
593604|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
593605|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
593606|NCT00976027|E2|Reported Event|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
593607|NCT00976027|E1|Reported Event|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
593608|NCT00976183|B1|Baseline|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.
Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.
Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
593609|NCT00976183|P1|Participant Flow|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.
Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.
Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
593610|NCT00976183|O1|Outcome|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.
Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.
Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
593611|NCT00976183|O1|Outcome|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.
Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.
Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
593612|NCT00976183|E1|Reported Event|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.
Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.
Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
593613|NCT00976209|B3|Baseline|Total|Total of all reporting groups
593647|NCT00976391|P1|Participant Flow|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
593614|NCT00976209|B2|Baseline|Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
593615|NCT00976209|B1|Baseline|Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
593616|NCT00976209|P2|Participant Flow|Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
593617|NCT00976209|P1|Participant Flow|Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
593618|NCT00976209|O1|Outcome|All Participants|Participants received Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days and Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days in a cross-over fashion. A 3 day (+/- 1 day) washout period separated the two treatment periods.
593619|NCT00976209|O1|Outcome|All Participants|Participants received Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days and Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days in a cross-over fashion. A 3 day (+/- 1 day) washout period separated the two treatment periods.
593620|NCT00976209|E2|Reported Event|Phenylephrine HCl IR, 10 mg|Phenylephrine Hydrochloride (HCl) Immediate Release tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.
593621|NCT00976209|E1|Reported Event|Phenylephrine HCl ER, 30 mg|Phenylephrine Hydrochloride (HCl) Extended Release (ER) tablets 30 mg taken every 12 hours, twice daily, for 3 days.
593622|NCT00976248|B1|Baseline|RAD001|"RAD001, oral, 10 mg, daily
RAD001 : Taken orally once a day"
593623|NCT00976248|P1|Participant Flow|RAD001|"RAD001, oral, 10 mg, daily
RAD001 : Taken orally once a day"
593624|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily
RAD001: Taken orally once a day"
593625|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily
RAD001: Taken orally once a day"
593626|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily
RAD001 : Taken orally once a day"
593627|NCT00976248|E1|Reported Event|RAD001|"RAD001, oral, 10 mg, daily
RAD001 : Taken orally once a day"
593628|NCT00976274|B3|Baseline|Total|Total of all reporting groups
593629|NCT00976274|B2|Baseline|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
593630|NCT00976274|B1|Baseline|Starch Capsule|5 capsules three times everyday for 12 weeks
593631|NCT00976274|P2|Participant Flow|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
593632|NCT00976274|P1|Participant Flow|Starch Capsule|5 capsules three times everyday for 12 weeks
593633|NCT00976274|O2|Outcome|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
593634|NCT00976274|O1|Outcome|Starch Capsule|5 capsules three times everyday for 12 weeks
593635|NCT00976274|O2|Outcome|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
593636|NCT00976274|O1|Outcome|Starch Capsule|5 capsules three times everyday for 12 weeks
593637|NCT00976274|E2|Reported Event|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
593638|NCT00976274|E1|Reported Event|Starch Capsule|5 capsules three times everyday for 12 weeks
593639|NCT00976339|B1|Baseline|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU weekly or 30,000 IU weekly, for 1 year
593640|NCT00976339|P1|Participant Flow|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU weekly or 30,000 IU weekly, for 1 year
593641|NCT00976339|O1|Outcome|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU or 30,000 IU weekly for 1 year
593642|NCT00976339|E1|Reported Event|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU weekly or 30,000 IU for 1 year
593643|NCT00976391|B3|Baseline|Total|Total of all reporting groups
593644|NCT00976391|B2|Baseline|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
593645|NCT00976391|B1|Baseline|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
593646|NCT00976391|P2|Participant Flow|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
593648|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
593649|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
593650|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
593651|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
593652|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
593653|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
593654|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
593655|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
593656|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
593657|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
593658|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
593824|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
595419|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
593659|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
593660|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
593661|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
593662|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
593663|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
593664|NCT00976391|E2|Reported Event|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
593665|NCT00976391|E1|Reported Event|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
593666|NCT00976404|B3|Baseline|Total|Total of all reporting groups
593667|NCT00976404|B2|Baseline|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
593668|NCT00976404|B1|Baseline|ART Intensification: Maraviroc +Raltegravir|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
593669|NCT00976404|P2|Participant Flow|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
593670|NCT00976404|P1|Participant Flow|ART Intensification: Maraviroc + Raltegravir|ART Intensification (addition of raltegravir and maraviroc) to suppressive ART for 56 weeks
593671|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
593672|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
593673|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
593674|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
593675|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
593676|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
593677|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
593678|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
593679|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
593680|NCT00976404|O1|Outcome|ART Intensification: Maraviroc +Raltegravir|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
593681|NCT00976404|E2|Reported Event|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
593682|NCT00976404|E1|Reported Event|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
593683|NCT00976456|B3|Baseline|Total|Total of all reporting groups
593684|NCT00976456|B2|Baseline|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin
Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
593685|NCT00976456|B1|Baseline|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed
Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
593686|NCT00976456|P2|Participant Flow|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin
Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
595402|NCT00980148|O2|Outcome|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
593687|NCT00976456|P1|Participant Flow|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed
Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
593688|NCT00976456|O2|Outcome|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin
Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
593689|NCT00976456|O1|Outcome|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed
Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
593690|NCT00976456|O2|Outcome|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin
Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
593691|NCT00976456|O1|Outcome|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed
Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
593692|NCT00976456|E2|Reported Event|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin
Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
593693|NCT00976456|E1|Reported Event|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed
Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
593694|NCT00976482|B1|Baseline|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
593695|NCT00976482|P1|Participant Flow|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
593696|NCT00976482|O1|Outcome|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
593697|NCT00976482|E1|Reported Event|Pacemaker|implanted Patients
593698|NCT00976495|B4|Baseline|Total|Total of all reporting groups
593699|NCT00976495|B3|Baseline|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
593700|NCT00976495|B2|Baseline|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
593701|NCT00976495|B1|Baseline|Placebo|Tablet, oral, once daily for 12 weeks
593702|NCT00976495|P3|Participant Flow|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
593703|NCT00976495|P2|Participant Flow|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
593704|NCT00976495|P1|Participant Flow|Placebo|Tablet, oral, once daily for 12 weeks
593705|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
593706|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
593707|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
593708|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
593709|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
593710|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
593716|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
593717|NCT00976495|E3|Reported Event|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
593718|NCT00976495|E2|Reported Event|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
593719|NCT00976495|E1|Reported Event|Placebo|Tablet, oral, once daily for 12 weeks
593720|NCT00976508|B3|Baseline|Total|Total of all reporting groups
593721|NCT00976508|B2|Baseline|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593722|NCT00976508|B1|Baseline|Figitumumab 20 mg/kg +Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593723|NCT00976508|P2|Participant Flow|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593724|NCT00976508|P1|Participant Flow|Figitumumab 20mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593725|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593726|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593825|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593826|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593727|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593728|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593729|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593730|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593731|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593732|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593733|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593734|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593773|NCT00976573|B2|Baseline|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593735|NCT00976508|O2|Outcome|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
593736|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593737|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593738|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593739|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593740|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593741|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
595403|NCT00980148|O1|Outcome|Azithromycin Arm|Azithromycin 1 gm oral single dose
593742|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593743|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593744|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593745|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593746|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593747|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593748|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593749|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593750|NCT00976508|O1|Outcome|Figitumumab 20mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593751|NCT00976508|E2|Reported Event|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
593752|NCT00976508|E1|Reported Event|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
593753|NCT00976521|B5|Baseline|Total|Total of all reporting groups
593754|NCT00976521|B4|Baseline|No Local Infusion, no Aspiration|No local infusion of abciximab and no thrombus aspiration
593755|NCT00976521|B3|Baseline|No Local Infusion, Thrombus Aspiration|No local infusion of abciximab, thrombus aspiration.
593756|NCT00976521|B2|Baseline|Local Infusion, no Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration
593757|NCT00976521|B1|Baseline|Local Infusion, Thrombus Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
593758|NCT00976521|P4|Participant Flow|No Local Infusion, no Aspiration|"No local infusion of abciximab and no thrombus aspiration.
The lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care."
593759|NCT00976521|P3|Participant Flow|No Local Infusion, Thrombus Aspiration|"No local infusion of abciximab, thrombus aspiration.
A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed."
593760|NCT00976521|P2|Participant Flow|Local Infusion, no Aspiration|"Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.
The initial device used to cross the lesion is a 1.0 mm or 1.5 mm diameter ClearWay™ RX Infusion Catheter (1.0 mm for complete occlusion).
If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter."
593827|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593828|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593761|NCT00976521|P1|Participant Flow|Local Infusion, Thrombus Aspiration|"Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed.
After withdrawing the aspiration catheter, the lesion is crossed with a 1.0 mm, 1.5 mm, or 2.0 mm diameter ClearWay™ RX Infusion Catheter (depending on the lumen diameter created by thrombus aspiration and the reference vessel diameter). If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter."
593762|NCT00976521|O3|Outcome|Combined|Combined includes subjects randomized to all four arms.
593763|NCT00976521|O2|Outcome|No Aspiration|No aspiration includes subjects randomized to either the following two arms: abciximab infusion arm without aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion without aspiration, the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter. If randomized to no abciximab without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
593764|NCT00976521|O1|Outcome|Thrombus Aspiration|Thrombus aspiration includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or no abciximab infusion with aspiration. A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter. Multiple passes should be made with contrast injection after each pass until the operator appreciates that no further thrombus is being removed.
593765|NCT00976521|O3|Outcome|Combined|Combined includes subjects randomized to all four arms.
593766|NCT00976521|O2|Outcome|No Infusion|No Infusion includes subjects randomized to either the following two arms: no abciximab infusion with aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion with aspiration, a 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until no further thrombus is being removed. If randomized to no abciximab infusion without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
593767|NCT00976521|O1|Outcome|Abciximab Infusion|Abciximab Infusion includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or abciximab infusion arm without aspiration. If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter.
593768|NCT00976521|E4|Reported Event|No Local Infusion, No Aspiration|No local infusion of abciximab and no thrombus aspiration.
593769|NCT00976521|E3|Reported Event|No Local Infusion, Thrombus Aspiration|No local infusion of abciximab, thrombus aspiration.
593770|NCT00976521|E2|Reported Event|Local Infusion, No Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.
593771|NCT00976521|E1|Reported Event|Local Infusion, Thrombus Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration
593772|NCT00976573|B3|Baseline|Total|Total of all reporting groups
593805|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593774|NCT00976573|B1|Baseline|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593775|NCT00976573|P2|Participant Flow|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593776|NCT00976573|P1|Participant Flow|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593777|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593778|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593779|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593780|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593781|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
595420|NCT00980174|O1|Outcome|Placebo|
593782|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593783|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593784|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593785|NCT00976573|E2|Reported Event|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593786|NCT00976573|E1|Reported Event|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
593787|NCT00976599|B3|Baseline|Total|Total of all reporting groups
593788|NCT00976599|B2|Baseline|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593789|NCT00976599|B1|Baseline|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593790|NCT00976599|P2|Participant Flow|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593791|NCT00976599|P1|Participant Flow|CP-690,550|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593792|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593793|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593794|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593795|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593796|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593797|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593798|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593799|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593800|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593801|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593802|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593803|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593804|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593806|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593807|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593808|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593809|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593810|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593811|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593812|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593813|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593814|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593815|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593816|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593817|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593818|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593819|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593820|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593821|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593822|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593823|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593829|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593830|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593831|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593832|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593833|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593834|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593835|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593836|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593837|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593838|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593839|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593840|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593841|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593842|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593843|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593844|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593845|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593846|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593847|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593848|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593849|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593850|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593851|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593852|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593853|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593854|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593855|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593856|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593857|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593858|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593859|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593860|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593861|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593862|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593863|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593864|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593865|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593866|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593867|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593868|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593869|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593870|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593871|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593872|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593873|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593874|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593875|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593876|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593877|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593878|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593879|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593880|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593881|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593882|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593883|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593884|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593885|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593886|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593887|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593888|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593889|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593890|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593891|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593892|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593893|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593894|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593895|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593896|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593897|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593898|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593899|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593900|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593901|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593902|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593903|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593904|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593905|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593906|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593907|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593908|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593909|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593910|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593911|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593912|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593913|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593914|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593915|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593916|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593917|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593918|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593919|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593920|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593921|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593922|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593923|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593924|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593925|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593926|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593927|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593928|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593929|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593930|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593931|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593932|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593933|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593934|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593935|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593936|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593937|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593938|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593939|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593940|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593941|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593942|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593943|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593944|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593945|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593946|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593947|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593948|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593949|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593950|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593951|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593952|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593953|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593954|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593955|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593956|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593957|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593958|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593959|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593960|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593961|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593962|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593963|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593964|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593965|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593966|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593967|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593968|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593969|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593970|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593971|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593972|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593973|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593974|NCT00976599|E2|Reported Event|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593975|NCT00976599|E1|Reported Event|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
593976|NCT00976664|B3|Baseline|Total|Total of all reporting groups
593977|NCT00976664|B2|Baseline|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
593978|NCT00976664|B1|Baseline|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
593979|NCT00976664|P2|Participant Flow|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
593980|NCT00976664|P1|Participant Flow|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
593981|NCT00976664|O2|Outcome|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
593982|NCT00976664|O1|Outcome|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
593983|NCT00976664|O2|Outcome|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
593984|NCT00976664|O1|Outcome|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
593985|NCT00976664|E2|Reported Event|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
593986|NCT00976664|E1|Reported Event|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
593987|NCT00976677|B3|Baseline|Total|Total of all reporting groups
594004|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
603942|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
593988|NCT00976677|B2|Baseline|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
593989|NCT00976677|B1|Baseline|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
593990|NCT00976677|P2|Participant Flow|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
593991|NCT00976677|P1|Participant Flow|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
593992|NCT00976677|O2|Outcome|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
593993|NCT00976677|O1|Outcome|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
594014|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
594074|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
593994|NCT00976677|E2|Reported Event|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
593995|NCT00976677|E1|Reported Event|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
593996|NCT00976703|B3|Baseline|Total|Total of all reporting groups
593997|NCT00976703|B2|Baseline|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
593998|NCT00976703|B1|Baseline|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
593999|NCT00976703|P2|Participant Flow|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
594000|NCT00976703|P1|Participant Flow|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
594001|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
594002|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
594003|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
594048|NCT00976937|B3|Baseline|Total|Total of all reporting groups
594147|NCT00977080|B1|Baseline|IV Paricalcitol in the IV Stratum|IV stratum
594148|NCT00977080|P4|Participant Flow|Cinacalcet in the Oral Stratum|Oral stratum
603946|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
594005|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
594006|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
594007|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
594008|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
594009|NCT00976703|E2|Reported Event|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
594010|NCT00976703|E1|Reported Event|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
594011|NCT00976716|B1|Baseline|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
594012|NCT00976716|P1|Participant Flow|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID (twice daily) for up to 7 days from Day 2.
594013|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
594071|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594015|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
594016|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
594017|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
594018|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
594019|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
594020|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
594021|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
594022|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
594023|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
594024|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
594025|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
594026|NCT00976716|E1|Reported Event|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
594027|NCT00976911|B3|Baseline|Total|Total of all reporting groups
594028|NCT00976911|B2|Baseline|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
594049|NCT00976937|B2|Baseline|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
612391|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
594029|NCT00976911|B1|Baseline|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
594030|NCT00976911|P2|Participant Flow|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
594031|NCT00976911|P1|Participant Flow|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks [q3w]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
594032|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
594072|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594033|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
594034|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
594035|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
594036|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
594037|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
594050|NCT00976937|B1|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 mg capsule orally QD up to Week 24.
594051|NCT00976937|P2|Participant Flow|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
594149|NCT00977080|P3|Participant Flow|Oral Paricalcitol in the Oral Stratum|Oral stratum
594038|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
594039|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
594040|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
594041|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
594073|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594042|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
594043|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
594044|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
594045|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
594046|NCT00976911|E2|Reported Event|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
594047|NCT00976911|E1|Reported Event|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
594052|NCT00976937|P1|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 milligram (mg) capsule orally QD up to Week 24.
594053|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594054|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594055|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594056|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594057|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594058|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594059|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594060|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594061|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594062|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594063|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594064|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594065|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594066|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594067|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594068|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594069|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594070|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
595421|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
594075|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594076|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594077|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594078|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594079|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594080|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594081|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594082|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594083|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594084|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594085|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594086|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594087|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594088|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594089|NCT00976937|E2|Reported Event|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
594090|NCT00976937|E1|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
594091|NCT00976950|B1|Baseline|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
594092|NCT00976950|P1|Participant Flow|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
594093|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
594094|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
594095|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
594096|NCT00976950|E1|Reported Event|Aptivus and Ritonavir|ARV means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
594097|NCT00976989|B4|Baseline|Total|Total of all reporting groups
594098|NCT00976989|B3|Baseline|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594099|NCT00976989|B2|Baseline|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594100|NCT00976989|B1|Baseline|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594101|NCT00976989|P3|Participant Flow|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594102|NCT00976989|P2|Participant Flow|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594103|NCT00976989|P1|Participant Flow|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594104|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594105|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594106|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594107|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594108|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594109|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
595422|NCT00980174|O1|Outcome|Placebo|
594110|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594111|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594112|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594113|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594114|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594115|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594116|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594117|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594118|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594119|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594120|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594121|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594122|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594123|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594124|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594125|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594126|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594127|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594128|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594129|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594130|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594131|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
595404|NCT00980148|E2|Reported Event|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
594132|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594133|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594134|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594135|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594136|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594137|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594138|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594139|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594140|NCT00976989|E3|Reported Event|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594141|NCT00976989|E2|Reported Event|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
594142|NCT00976989|E1|Reported Event|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
594143|NCT00977080|B5|Baseline|Total|Total of all reporting groups
594144|NCT00977080|B4|Baseline|Cinacalcet in the Oral Stratum|Oral stratum
594145|NCT00977080|B3|Baseline|Oral Paricalcitol in the Oral Stratum|Oral stratum
594146|NCT00977080|B2|Baseline|Cinacalcet in the IV Stratum|IV stratum
594150|NCT00977080|P2|Participant Flow|Cinacalcet in the IV Stratum|IV stratum
594151|NCT00977080|P1|Participant Flow|IV Paricalcitol in the IV Stratum|IV stratum
594152|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
594153|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
594154|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
594155|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
594156|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
594157|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
594158|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
594159|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
594160|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
594161|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
594162|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
594163|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
594164|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
594165|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
594166|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
594167|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
594168|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
594169|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
594170|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
594171|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
594172|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
594173|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
594174|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
594175|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
594176|NCT00977080|E4|Reported Event|Cinacalcet in the Oral Stratum|Oral stratum
594177|NCT00977080|E3|Reported Event|Oral Paricalcitol in the Oral Stratum|Oral stratum
594178|NCT00977080|E2|Reported Event|Cinacalcet in the IV Stratum|IV stratum
594179|NCT00977080|E1|Reported Event|IV Paricalcitol in the IV Stratum|IV stratum
594180|NCT00977106|B3|Baseline|Total|Total of all reporting groups
594181|NCT00977106|B2|Baseline|Tocilizumab|Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594204|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594182|NCT00977106|B1|Baseline|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594183|NCT00977106|P2|Participant Flow|Tocilizumab|Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594184|NCT00977106|P1|Participant Flow|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) intravenously (IV) during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 milligrams per kilogram (mg/kg; 800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594185|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594186|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594187|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594188|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594189|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594190|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594191|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594192|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594193|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594194|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594794|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594195|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594196|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594197|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594198|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594199|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594200|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594201|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594202|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594203|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594313|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594205|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594206|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594207|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594208|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594209|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594210|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594211|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594212|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594213|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594214|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594215|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594216|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594217|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594860|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
594218|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594219|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594220|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594221|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594222|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594223|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594224|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594225|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594271|NCT00977171|B1|Baseline|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
594360|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
594226|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594227|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594228|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594229|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594230|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594231|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594232|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594233|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594234|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594235|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594236|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594237|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594238|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594861|NCT00970853|O1|Outcome|Control|Control group
594239|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594240|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594241|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594242|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594243|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594244|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594245|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594246|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594247|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
595423|NCT00980174|E2|Reported Event|Denosumab 60 mg Q6M|
594248|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594249|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594250|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594251|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594252|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594253|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594254|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594255|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594256|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594257|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594258|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594259|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594260|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594261|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594348|NCT00968708|P1|Participant Flow|Placebo|Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
594862|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
594262|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594263|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594264|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594265|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594266|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594267|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594268|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594269|NCT00977106|E2|Reported Event|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
594270|NCT00977106|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
594361|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
594272|NCT00977171|P1|Participant Flow|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
594273|NCT00977171|O1|Outcome|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
594274|NCT00977171|E1|Reported Event|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
594275|NCT00977184|B3|Baseline|Total|Total of all reporting groups
594276|NCT00977184|B2|Baseline|Sham rTMS|Subjects receiving sham rTMS.
594277|NCT00977184|B1|Baseline|Real rTMS|Subjects receiving real rTMS
594278|NCT00977184|P2|Participant Flow|Sham rTMS|Subjects receiving sham rTMS.
594279|NCT00977184|P1|Participant Flow|Real rTMS|Subjects receiving real rTMS
594280|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
594281|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
594282|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
594283|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
594284|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
594285|NCT00977184|O3|Outcome|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
594286|NCT00977184|O2|Outcome|Off Medictation Real rTMS|Subjects OFF medication while receiving REAL rTMS
594287|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
594288|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
594289|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
594290|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
594291|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
594292|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
594293|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
594294|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
594295|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
594296|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
594297|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
594298|NCT00977184|O2|Outcome|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
594299|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
594300|NCT00977184|E4|Reported Event|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
594301|NCT00977184|E3|Reported Event|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
594302|NCT00977184|E2|Reported Event|Off Medictation Real rTMS|Subjects OFF medication while receiving REAL rTMS
594303|NCT00977184|E1|Reported Event|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
594304|NCT00977197|B3|Baseline|Total|Total of all reporting groups
594305|NCT00977197|B2|Baseline|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594383|NCT00968812|E5|Reported Event|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
594863|NCT00970853|O1|Outcome|Control|Control group
594306|NCT00977197|B1|Baseline|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594307|NCT00977197|P2|Participant Flow|Placebo|"Subjects randomized to this arm will receive placebo matching the study drug.
Placebo: A matching placebo will be administered twice a day"
594308|NCT00977197|P1|Participant Flow|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
Pregabalin: Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594309|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594310|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594311|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594312|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594397|NCT00968890|B3|Baseline|Total|Total of all reporting groups
594314|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594315|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594316|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594317|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594318|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594319|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594320|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594321|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594322|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594323|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594324|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594325|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594326|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594327|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594529|NCT00969540|O2|Outcome|Total Sleep With Active Mattress Cover|Total sleep with active mattress cover (minutes).
594328|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594329|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594330|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594331|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594332|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594333|NCT00977197|E2|Reported Event|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
594334|NCT00977197|E1|Reported Event|Pregabalin|"Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
594335|NCT00977314|B3|Baseline|Total|Total of all reporting groups
594336|NCT00977314|B2|Baseline|Pilot Group|A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.
594337|NCT00977314|B1|Baseline|Analyzed Group|A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.
594338|NCT00977314|P2|Participant Flow|Pilot Group|"Per the protocol, the first five (5) subjects were enrolled in the pilot group of the study to work out the process flow and training of the centers and participants."
594339|NCT00977314|P1|Participant Flow|Analyzed Group|30 subjects were enrolled in the analyzed group with only 24 subjects expected to complete it. With an approximated 20% subject dropout rate anticipated. The total number of subjects that completed the study was 28 of 30 enrolled in the analyzed group.
594340|NCT00977314|O1|Outcome|Global Benefit|The Global Benefit APHAB at 30 days is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 30 days of therapy. The APHAB questionnaire produces an overall Global score (GBL). The benefit provided by the SoundBite System can be determined by comparing changes in the mean APHAB score. The larger the APHAB benefit score the great the benefit. A negative APHAB score represents therapy resulting in a worse outcome than no therapy.
594341|NCT00977314|O1|Outcome|HINT (dB) Advantage|"Effectiveness was defined as “Change from Baseline” analysis of the Hearing in Noise Test (HINT), Noise on Better Side Scores between without the BCD at day one and with the BCD at day thirty.Effectiveness was determined as an improvement in the HINT score for which the device was designed, that is, the condition where noise originates on the normal hearing side and speech is presented from the front. .
An improvement in HINT score is indicated as a negative (-) dB value change. A change in the HINT score of -1 dB represents an improvement of 10% in speech intelligibility in that particular test condition. A 10% improvement in speech intelligibility in this very adverse listening condition is a noticeable benefit to the SSD subject. This amount of improvement is even more of a benefit in more realistic, less adverse listening conditions."
594342|NCT00977314|O1|Outcome|Medical, Dental, Audiological Safety 30 Days|"The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:
Comprehensive Medical evaluation at Enrollment and at Termination
Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed
Comprehensive Audiological evaluation at Enrollment and Termination.
No Medical, Dental or Audiological adverse events."
594343|NCT00977314|E1|Reported Event|Incidence of Device- and Procedure-related Adverse Events|Incidence of device- and procedure-related adverse events at 30 days
594344|NCT00968708|B3|Baseline|Total|Total of all reporting groups
594345|NCT00968708|B2|Baseline|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
594346|NCT00968708|B1|Baseline|Placebo|Alogliptin placebo matching tablets, orally, once daily.
594347|NCT00968708|P2|Participant Flow|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
594530|NCT00969540|O1|Outcome|Total Sleep With Placebo Mattress Cover|Total sleep with placebo mattress cover (minutes).
594349|NCT00968708|O2|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
594350|NCT00968708|O1|Outcome|Placebo|Alogliptin placebo matching tablets, orally, once daily.
594351|NCT00968708|O2|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
594352|NCT00968708|O1|Outcome|Placebo|Alogliptin placebo matching tablets, orally, once daily.
594353|NCT00968708|E2|Reported Event|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
594354|NCT00968708|E1|Reported Event|Placebo|Alogliptin placebo matching tablets, orally, once daily.
594355|NCT00968799|B1|Baseline|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
594356|NCT00968799|P1|Participant Flow|HIPEC|"Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
Tumor nodules are removed surgically. If necessary infested organs like colon are resected (=cytoreduction).
To destroy remaining tumor cells or invisible nodules the peritoneum is prefused with 42°C warm 25 mg/l cisplatin solution. Perfusion volume depends on body size (3 - 6 l).
If cisplatin amount exceeds the equivalent of 62.5 mg/m² body surface, cisplatin is dosed by body surface (62.5 mg/m²)(safety margin).
Perfusion is performed with the open or Coliseum technique for 90 min."
594357|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
594358|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
594359|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
594362|NCT00968799|E1|Reported Event|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
594363|NCT00968812|B4|Baseline|Total|Total of all reporting groups
594364|NCT00968812|B3|Baseline|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
594365|NCT00968812|B2|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594366|NCT00968812|B1|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594367|NCT00968812|P3|Participant Flow|Glimepiride: Baseline to Week 104|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
594368|NCT00968812|P2|Participant Flow|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594369|NCT00968812|P1|Participant Flow|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594370|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
594371|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594372|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594373|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
594374|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594375|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594376|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
594377|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594378|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594379|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
594380|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594381|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
594382|NCT00968812|E6|Reported Event|Glimepiride: Baseline to Week 104|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
594531|NCT00969540|O2|Outcome|Nighttime Wake Time With Active Mattress Cover|Nighttime wake time after sleep onset with active mattress cover.
594384|NCT00968812|E4|Reported Event|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
594385|NCT00968812|E3|Reported Event|Glimepiride: Baseline to Week 52|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
594386|NCT00968812|E2|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
594387|NCT00968812|E1|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
594388|NCT00968838|B3|Baseline|Total|Total of all reporting groups
594389|NCT00968838|B2|Baseline|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
594390|NCT00968838|B1|Baseline|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
594391|NCT00968838|P2|Participant Flow|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
594392|NCT00968838|P1|Participant Flow|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
594393|NCT00968838|O2|Outcome|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
594394|NCT00968838|O1|Outcome|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
594395|NCT00968838|E2|Reported Event|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
594396|NCT00968838|E1|Reported Event|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
594398|NCT00968890|B2|Baseline|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594399|NCT00968890|B1|Baseline|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594400|NCT00968890|P2|Participant Flow|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594401|NCT00968890|P1|Participant Flow|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594402|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594403|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594404|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594405|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594406|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594407|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594408|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594409|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594410|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
612395|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
594411|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594412|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594413|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594414|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594415|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594416|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594417|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594418|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594419|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594420|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594421|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594422|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594423|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594424|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594425|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594426|NCT00968890|E2|Reported Event|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
594427|NCT00968890|E1|Reported Event|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
594428|NCT00968981|B4|Baseline|Total|Total of all reporting groups
594429|NCT00968981|B3|Baseline|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594430|NCT00968981|B2|Baseline|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594431|NCT00968981|B1|Baseline|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594432|NCT00968981|P3|Participant Flow|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule once weekly (QW) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594433|NCT00968981|P2|Participant Flow|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule three times weekly (TIW) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594434|NCT00968981|P1|Participant Flow|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule once daily (QD) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594435|NCT00968981|O1|Outcome|GDC-0449 150 mg: All Participants|All participants received single dose of GDC-0449 150 mg capsule orally on Day 1.
594795|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594436|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594437|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594438|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594439|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594440|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594441|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594442|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594443|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594444|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594445|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594446|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594447|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594475|NCT00969150|B3|Baseline|Total|Total of all reporting groups
594448|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594449|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594450|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC­0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594451|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594452|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594453|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594454|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594455|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594456|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594457|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594458|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594459|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594460|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594461|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594462|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594463|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594532|NCT00969540|O1|Outcome|Nighttime Wake Time With Placebo Mattress Cover|Nighttime wake time after sleep onset with placebo mattress cover.
594464|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594465|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594466|NCT00968981|E3|Reported Event|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
594467|NCT00968981|E2|Reported Event|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
594468|NCT00968981|E1|Reported Event|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
594469|NCT00969124|B1|Baseline|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
594470|NCT00969124|P1|Participant Flow|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
594471|NCT00969124|O1|Outcome|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
594472|NCT00969124|O1|Outcome|Third Eye Retroscope|"All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
Third Eye Retroscope: Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy"
594473|NCT00969124|O1|Outcome|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
594474|NCT00969124|E1|Reported Event|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
594476|NCT00969150|B2|Baseline|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
594477|NCT00969150|B1|Baseline|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
594478|NCT00969150|P2|Participant Flow|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
594479|NCT00969150|P1|Participant Flow|Placebo|Dose Matched placebo capsules, oral administration, once daily dosing for 8 weeks.
594480|NCT00969150|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
594481|NCT00969150|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
594482|NCT00969150|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
594483|NCT00969150|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
594484|NCT00969150|E2|Reported Event|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
594485|NCT00969150|E1|Reported Event|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
594486|NCT00969228|B3|Baseline|Total|Total of all reporting groups
594487|NCT00969228|B2|Baseline|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
594488|NCT00969228|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
594489|NCT00969228|P2|Participant Flow|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
594490|NCT00969228|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
594491|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
594492|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
594493|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
594494|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
594495|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
594496|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
594497|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
594498|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
594499|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
594500|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
594501|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
594502|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
594503|NCT00969228|E2|Reported Event|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
594504|NCT00969228|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
594505|NCT00969280|B3|Baseline|Total|Total of all reporting groups
594506|NCT00969280|B2|Baseline|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
594507|NCT00969280|B1|Baseline|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
594508|NCT00969280|P2|Participant Flow|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
594509|NCT00969280|P1|Participant Flow|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
594510|NCT00969280|O2|Outcome|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
594553|NCT00969709|B2|Baseline|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
594511|NCT00969280|O1|Outcome|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
594512|NCT00969280|E2|Reported Event|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
594513|NCT00969280|E1|Reported Event|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
594514|NCT00969501|B1|Baseline|EUFLEXXA|ACTIVE CONTROL
594515|NCT00969501|P1|Participant Flow|EUFLEXXA|All subjects received three injections (one each, in weeks 0 [baseline], 1, and 2 of high molecular weight hyaluronate (2.5 mL each) using standard injection techniques in the anterior or posterior approach. Sub- jects were evaluated at screening and baseline, and at weeks 1, 2, 6, 14, 26, and 27 (last evaluation by telephone).
594516|NCT00969501|O1|Outcome|EUFLEXXA|ACTIVE CONTROL
594517|NCT00969501|E1|Reported Event|EUFLEXXA|ACTIVE CONTROL
594518|NCT00969540|B3|Baseline|Total|Total of all reporting groups
594519|NCT00969540|B2|Baseline|Active Mattress Cover First, Then Placebo Mattress Cover|Subjects in this crossover double blind designed trial will be randomized into the active mattress cover group for 14 days. After a 7 day washout, they will be entered into the placebo mattress cover group for 14 days.
594520|NCT00969540|B1|Baseline|Placebo Mattress Cover First, Then Active Mattress Cover|Subjects in this crossover double blind designed trial will be randomized into the placebo mattress cover group for 14 days. After a 7 day washout, they will be entered into the active mattress cover group for 14 days.
594521|NCT00969540|P2|Participant Flow|Active Mattress Cover First, Then Placebo Mattress Cover|Subjects were randomly assigned in this crossover double blind designed trial to the active mattress cover or placebo mattress cover for 14 days.
594522|NCT00969540|P1|Participant Flow|Placebo Mattress Cover First, Then Active Mattress Cover|Subjects were randomly assigned in this crossover double blind designed trial to the placebo mattress cover or active mattress cover for 14 days.
594523|NCT00969540|O2|Outcome|Sleep Latency With Active Mattress Cover|Sleep latency with active mattress cover (minutes).
594524|NCT00969540|O1|Outcome|Sleep Latency With Placebo Mattress Cover|Sleep latency with placebo mattress cover (minutes).
594525|NCT00969540|O2|Outcome|Sleep Efficiency With Active Mattress Cover|Sleep efficiency with active mattress cover.
594526|NCT00969540|O1|Outcome|Sleep Efficiency With Placebo Mattress Cover|Sleep efficiency with placebo mattress cover.
594527|NCT00969540|O2|Outcome|Nocturnal Awakenings With Active Mattress Cover|Number of nocturnal awakenings with active mattress cover.
594528|NCT00969540|O1|Outcome|Nocturnal Awakenings With Placebo Mattress Cover|Number of nocturnal awakenings with placebo mattress cover.
594533|NCT00969540|O4|Outcome|Mean CGI Sleep Scores With Active Mattress Cover.|Mean Clinical Global Impression sleep scores with active mattress cover.
594534|NCT00969540|O3|Outcome|Mean CGI Sleep Scores With Placebo Mattress Cover.|Mean Clinical Global Impression sleep scores with placebo mattress cover.
594535|NCT00969540|O2|Outcome|Mean CGI Pain Scores With Active Mattress Cover.|Mean Clinical Global Impression pain scores with active mattress cover.
594536|NCT00969540|O1|Outcome|Mean CGI Pain Scores With Placebo Mattress Cover.|Mean Clinical Global Impression pain scores with placebo mattress cover.
594537|NCT00969540|E2|Reported Event|Active Mattress Cover|Subjects will be randomly assigned in this crossover double blind designed trial to the active mattress cover for 14 days, followed by the placebo mattress cover for 14 days after a 7 day wash out period.
594538|NCT00969540|E1|Reported Event|Placebo Mattress Cover|Subjects will be randomly assigned in this crossover double blind designed trial to the placebo mattress cover for 14 days, followed by the active mattress cover for 14 days after a 7 day wash out period.
594539|NCT00969618|B1|Baseline|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
594540|NCT00969618|P1|Participant Flow|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
594541|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
594542|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
594543|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
594544|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
594545|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
594546|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
594547|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
594548|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
594549|NCT00969618|E1|Reported Event|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
594550|NCT00969709|B5|Baseline|Total|Total of all reporting groups
594551|NCT00969709|B4|Baseline|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
594552|NCT00969709|B3|Baseline|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
594554|NCT00969709|B1|Baseline|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks
594555|NCT00969709|P4|Participant Flow|Levomilnacipran ER 120 mg|"120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing
Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks."
594556|NCT00969709|P3|Participant Flow|Levomilnacipran ER 80 mg|"80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing
Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks."
594557|NCT00969709|P2|Participant Flow|Levomilnacipran ER 40 mg|"40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.
Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks."
594558|NCT00969709|P1|Participant Flow|Placebo|"Dose matching placebo capsules, oral administration, once daily dosing.
Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks."
594559|NCT00969709|O4|Outcome|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
594560|NCT00969709|O3|Outcome|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
594561|NCT00969709|O2|Outcome|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
594562|NCT00969709|O1|Outcome|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks
594563|NCT00969709|O4|Outcome|Levomilnacipran ER 120 mg|"120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing
Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks."
594564|NCT00969709|O3|Outcome|Levomilnacipran ER 80 mg|"80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing
Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks."
594565|NCT00969709|O2|Outcome|Levomilnacipran ER 40 mg|"40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.
Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks."
594566|NCT00969709|O1|Outcome|Placebo|"Dose matching placebo capsules, oral administration, once daily dosing.
Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks."
594567|NCT00969709|E4|Reported Event|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
594568|NCT00969709|E3|Reported Event|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
594569|NCT00969709|E2|Reported Event|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER, low dose, oral administration, once daily for 8 weeks.
594570|NCT00969709|E1|Reported Event|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks.
594571|NCT00969878|B3|Baseline|Total|Total of all reporting groups
594572|NCT00969878|B2|Baseline|TA-CD Vaccination|"TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).
TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor."
594796|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594573|NCT00969878|B1|Baseline|Placebo Injection|"TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).
Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor."
594574|NCT00969878|P2|Participant Flow|TA-CD Vaccination|"TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).
TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor."
594575|NCT00969878|P1|Participant Flow|Placebo Injection|"TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).
Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor."
594576|NCT00969878|O2|Outcome|TA-CD Vaccination|Subjects randomized to the active medication group were injected with the active TA-CD at preset intervals per protocol specifications.
594577|NCT00969878|O1|Outcome|Placebo Injection|Subjects randomized to the placebo group were injected with a saline solution on the same schedule as those in the active medication group.
594578|NCT00969878|O2|Outcome|TA-CD Vaccination|The group randomized to receive the active medication, received the actual TA-CD vaccination at preset intervals as specified in the approved protocol.
594579|NCT00969878|O1|Outcome|Placebo Injection|A saline injection to mimic the active medication is administered to the Placebo group.
594580|NCT00969878|E2|Reported Event|TA-CD Vaccination|Subjects randomized to the active medication group were injected with the active TA-CD at preset intervals per protocol specifications.
594822|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594581|NCT00969878|E1|Reported Event|Placebo Injection|Subjects randomized to the placebo group were injected with a saline solution on the same schedule as those in the active medication group.
594582|NCT00970216|B1|Baseline|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
594583|NCT00970216|P1|Participant Flow|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
594584|NCT00970216|O1|Outcome|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
594585|NCT00970216|E1|Reported Event|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
594586|NCT00970268|B3|Baseline|Total|Total of all reporting groups
594587|NCT00970268|B2|Baseline|Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
594588|NCT00970268|B1|Baseline|Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
594589|NCT00970268|P2|Participant Flow|Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
594590|NCT00970268|P1|Participant Flow|Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
594591|NCT00970268|O4|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
594592|NCT00970268|O3|Outcome|Placebo - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
594593|NCT00970268|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
594594|NCT00970268|O1|Outcome|Placebo - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
594595|NCT00970268|O4|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 microgram of Aclidinium bromide for 12 weeks in the lead-in study.
594596|NCT00970268|O3|Outcome|Placebo - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation, twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
594597|NCT00970268|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
594598|NCT00970268|O1|Outcome|Placebo - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
594599|NCT00970268|E4|Reported Event|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg|Patients were given 12 weeks of Aclidinium bromide, 400 microgram dose, then continued with the 400 microgram dose twice per day, oral inhalation, for an additional 52 weeks of treatment.
594600|NCT00970268|E3|Reported Event|Placebo to Aclidinium Bromide 400μg|Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment
594797|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
612530|NCT01023815|B5|Baseline|Total|Total of all reporting groups
594601|NCT00970268|E2|Reported Event|Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg|Patients were given 12 weeks of Aclidinium bromide, 200 microgram dose, then continued with the 200 microgram dose, oral inhalation twice per day for an additional 52 weeks of treatment.
594602|NCT00970268|E1|Reported Event|Placebo to Aclidinium Bromide 200 μg|Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment
594603|NCT00970281|B3|Baseline|Total|Total of all reporting groups
594604|NCT00970281|B2|Baseline|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594605|NCT00970281|B1|Baseline|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594606|NCT00970281|P2|Participant Flow|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594607|NCT00970281|P1|Participant Flow|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594608|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594609|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594610|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594611|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594612|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594613|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594614|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594615|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594616|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594617|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594618|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594619|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594620|NCT00970281|E2|Reported Event|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594621|NCT00970281|E1|Reported Event|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
594622|NCT00970294|B1|Baseline|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
594623|NCT00970294|P1|Participant Flow|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
594624|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
594625|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
594626|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
594627|NCT00970294|E1|Reported Event|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
594628|NCT00970307|B4|Baseline|Total|Total of all reporting groups
594629|NCT00970307|B3|Baseline|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594630|NCT00970307|B2|Baseline|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594631|NCT00970307|B1|Baseline|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594632|NCT00970307|P3|Participant Flow|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594633|NCT00970307|P2|Participant Flow|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594634|NCT00970307|P1|Participant Flow|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594635|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594636|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594637|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594638|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594823|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594639|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594640|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594641|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594642|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594643|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594644|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594645|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594646|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594647|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594798|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
616517|NCT01031979|B3|Baseline|Total|Total of all reporting groups
594648|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594649|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594650|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594651|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594652|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594653|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594654|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594655|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594656|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594657|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594658|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594659|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594660|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594661|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594662|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594799|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
616956|NCT01032759|B2|Baseline|Placebo|"Placebo
Placebo: BID"
594663|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594664|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594665|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594666|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594667|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594668|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594669|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594670|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594671|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594672|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594673|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594674|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594675|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594676|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594677|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594800|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
616957|NCT01032759|B1|Baseline|Memantine|Memantine: 20 mg, BID
594678|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594679|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594680|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594681|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594682|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594683|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594684|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594685|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594686|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594687|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594688|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594689|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594690|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594691|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594692|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594801|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
616958|NCT01032759|P2|Participant Flow|Placebo|"Placebo
Placebo: BID"
594693|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594694|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594695|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594696|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594697|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594698|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594699|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594700|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594701|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594702|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594703|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594704|NCT00970307|E3|Reported Event|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594705|NCT00970307|E2|Reported Event|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594706|NCT00970307|E1|Reported Event|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
594707|NCT00970320|B6|Baseline|Total|Total of all reporting groups
594708|NCT00970320|B5|Baseline|Prevalence Study|1571 primiparas delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
594709|NCT00970320|B4|Baseline|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
594864|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
594710|NCT00970320|B3|Baseline|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
594711|NCT00970320|B2|Baseline|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
594712|NCT00970320|B1|Baseline|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
594713|NCT00970320|P5|Participant Flow|Prevalence Study|1571 primiparas delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.
594714|NCT00970320|P4|Participant Flow|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
594715|NCT00970320|P3|Participant Flow|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
594716|NCT00970320|P2|Participant Flow|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
594717|NCT00970320|P1|Participant Flow|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
594718|NCT00970320|O5|Outcome|Prevalence Study|1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
594719|NCT00970320|O4|Outcome|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
594824|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594720|NCT00970320|O3|Outcome|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
594721|NCT00970320|O2|Outcome|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
594722|NCT00970320|O1|Outcome|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
594723|NCT00970320|E5|Reported Event|Prevalence Study|1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
594724|NCT00970320|E4|Reported Event|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
594725|NCT00970320|E3|Reported Event|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
594726|NCT00970320|E2|Reported Event|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).
Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
594727|NCT00970320|E1|Reported Event|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
594728|NCT00970359|B1|Baseline|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet
The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
594729|NCT00970359|P1|Participant Flow|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet
The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
594749|NCT00970502|B1|Baseline|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
594802|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594730|NCT00970359|O1|Outcome|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet
The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
594731|NCT00970359|O1|Outcome|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet
The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
594732|NCT00970359|O1|Outcome|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet
The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
594733|NCT00970359|E1|Reported Event|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet
The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
594734|NCT00970489|B3|Baseline|Total|Total of all reporting groups
594735|NCT00970489|B2|Baseline|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
594736|NCT00970489|B1|Baseline|Olive Oil Capsule|Placebo : Olive Oil capsules
594737|NCT00970489|P2|Participant Flow|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
594738|NCT00970489|P1|Participant Flow|Olive Oil Capsule|"Placebo : Olive Oil capsules All patients were randomized to receive n-3 Polyunsaturated fatty acids (PUFA) or matched placebo in equal numbers using computer-generated numbers, stratified by medical center.
Treatment: Either oral n-3 PUFA (1 g capsules, each containing ~850 mg of EPA+DHA) or matching placebo (olive oil, 1 g capsules).
Total loading dose = 8 g over 2 to 4 days pre-op, followed by 2 g/d post-op until hospital discharge or until post-op day 10, whichever sooner."
594739|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
594740|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
594741|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
594742|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
594743|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
594744|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
594745|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
594746|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
594747|NCT00970489|E2|Reported Event|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
594748|NCT00970489|E1|Reported Event|Olive Oil Capsule|Placebo : Olive Oil capsules
594792|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594793|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594865|NCT00970853|O1|Outcome|Control|Control group
594750|NCT00970502|P1|Participant Flow|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
594751|NCT00970502|O1|Outcome|Erlotinib + Celecoxib|Recommended dose of celecoxib was 400mg
594752|NCT00970502|O1|Outcome|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
594753|NCT00970502|O1|Outcome|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
594754|NCT00970502|O3|Outcome|Celecoxib 600mg|Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily
594755|NCT00970502|O2|Outcome|Celecoxib 400mg|Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily
594756|NCT00970502|O1|Outcome|Celecoxib 200mg|Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily
594757|NCT00970502|E1|Reported Event|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
594758|NCT00970606|B3|Baseline|Total|Total of all reporting groups
594825|NCT00970632|E3|Reported Event|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594759|NCT00970606|B2|Baseline|Rosuvastatin (Crestor)|"Experimental arm
Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
594760|NCT00970606|B1|Baseline|Placebo Tablet|"Placebo
Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
594761|NCT00970606|P2|Participant Flow|Rosuvastatin (Crestor)|"Experimental arm
Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
594762|NCT00970606|P1|Participant Flow|Placebo Tablet|"Placebo
Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
594763|NCT00970606|O2|Outcome|Rosuvastatin (Crestor)|"Experimental arm
Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
594764|NCT00970606|O1|Outcome|Placebo Tablet|"Placebo
Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
594765|NCT00970606|E2|Reported Event|Rosuvastatin (Crestor)|"Experimental arm
Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
594766|NCT00970606|E1|Reported Event|Placebo Tablet|"Placebo
Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
594767|NCT00970632|B4|Baseline|Total|Total of all reporting groups
594768|NCT00970632|B3|Baseline|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594769|NCT00970632|B2|Baseline|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594770|NCT00970632|B1|Baseline|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594771|NCT00970632|P3|Participant Flow|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594772|NCT00970632|P2|Participant Flow|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594773|NCT00970632|P1|Participant Flow|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594774|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594775|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594776|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594777|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594778|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594779|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594780|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594781|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594782|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594783|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594784|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594785|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594786|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594787|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594788|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594789|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594790|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594791|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594803|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594804|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594805|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594806|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594807|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594808|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594809|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594810|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594811|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594812|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594813|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594814|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594815|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594816|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594817|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594818|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594819|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594820|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594821|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
594826|NCT00970632|E2|Reported Event|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
594827|NCT00970632|E1|Reported Event|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
594828|NCT00970684|B1|Baseline|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
594829|NCT00970684|P1|Participant Flow|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
594830|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
594831|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
594832|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
594833|NCT00970684|E1|Reported Event|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
594834|NCT00970736|B1|Baseline|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
594835|NCT00970736|P1|Participant Flow|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
594836|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
594837|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
594838|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
594839|NCT00970736|E1|Reported Event|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
594840|NCT00970814|B3|Baseline|Total|Total of all reporting groups
594841|NCT00970814|B2|Baseline|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
594842|NCT00970814|B1|Baseline|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
594843|NCT00970814|P2|Participant Flow|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
594844|NCT00970814|P1|Participant Flow|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
594845|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
594846|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
594847|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
594848|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
594849|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
594850|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
594851|NCT00970814|E2|Reported Event|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
594852|NCT00970814|E1|Reported Event|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
594853|NCT00970853|B3|Baseline|Total|Total of all reporting groups
594854|NCT00970853|B2|Baseline|MOM Program Home Visiting|Mixed professional support home visiting program.
594855|NCT00970853|B1|Baseline|Control|Control group
594856|NCT00970853|P2|Participant Flow|MOM Program Home Visiting|Mixed professional support home visiting program.
594857|NCT00970853|P1|Participant Flow|Control|Control group
594858|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
594859|NCT00970853|O1|Outcome|Control|Control group
594866|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
594867|NCT00970853|O1|Outcome|Control|Control group
594868|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
594869|NCT00970853|O1|Outcome|Control|Control group
594870|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
594871|NCT00970853|O1|Outcome|Control|Control group
594872|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
594873|NCT00970853|O1|Outcome|Control|Control group
594874|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
594875|NCT00970853|O1|Outcome|Control|Control group
594876|NCT00970853|E2|Reported Event|MOM Program Home Visiting|Mixed professional support home visiting program.
594877|NCT00970853|E1|Reported Event|Control|Control group
594878|NCT00970944|B3|Baseline|Total|Total of all reporting groups
594879|NCT00970944|B2|Baseline|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
594880|NCT00970944|B1|Baseline|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
594881|NCT00970944|P2|Participant Flow|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
594882|NCT00970944|P1|Participant Flow|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
594883|NCT00970944|O2|Outcome|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
594884|NCT00970944|O1|Outcome|Amantadine|Amantadine (200-400 mg/day)
594885|NCT00970944|O2|Outcome|Placebo|Visually identical compound administered in the same manner (ie enterally) as the study drug.
594886|NCT00970944|O1|Outcome|Amantadine|Amantadine (200-400 mg/day)
594887|NCT00970944|E2|Reported Event|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
594973|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
594974|NCT00977470|E2|Reported Event|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
594888|NCT00970944|E1|Reported Event|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
594889|NCT00971048|B5|Baseline|Total|Total of all reporting groups
594890|NCT00971048|B4|Baseline|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
594891|NCT00971048|B3|Baseline|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
594892|NCT00971048|B2|Baseline|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)"
594893|NCT00971048|B1|Baseline|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
594894|NCT00971048|P4|Participant Flow|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
594895|NCT00971048|P3|Participant Flow|HP828-101 Treating PU|HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had pressure ulcers (PU)
594896|NCT00971048|P2|Participant Flow|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU (3M Tegaderm Hydrogel)"
594897|NCT00971048|P1|Participant Flow|HP828-101 Treating DFU|HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had diabetic foot ulcers (DFU)
594898|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
594899|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had pressure ulcers (PU)
594900|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)"
594901|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had diabetic foot ulcers (DFU)
594902|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
594903|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had pressure ulcers (PU)
594904|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)"
594905|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had diabetic foot ulcers (DFU)
594906|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
594907|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
594908|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)"
594909|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
595031|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
594910|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
594911|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
594912|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)"
594913|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
594914|NCT00971048|E4|Reported Event|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
594915|NCT00971048|E3|Reported Event|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
594916|NCT00971048|E2|Reported Event|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)"
594917|NCT00971048|E1|Reported Event|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
594918|NCT00977379|B3|Baseline|Total|Total of all reporting groups
594919|NCT00977379|B2|Baseline|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594920|NCT00977379|B1|Baseline|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594975|NCT00977470|E1|Reported Event|Erlotinib|Erlotinib: 150 mg taken orally once daily
595405|NCT00980148|E1|Reported Event|Azithromycin Arm|Azithromycin 1 gm oral single dose
594921|NCT00977379|P2|Participant Flow|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 milligrams per square meter (mg/m^2) orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594922|NCT00977379|P1|Participant Flow|WBRT Followed by Standard of Care|Participants received 3000 centi-Gray (cGy) whole brain radiation therapy (WBRT) in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (central nervous system [CNS] or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594923|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594924|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594925|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594926|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594927|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594928|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
595032|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
616959|NCT01032759|P1|Participant Flow|Memantine|Memantine: 20 mg, BID
594929|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594930|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594931|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594932|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594976|NCT00977548|B1|Baseline|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
594977|NCT00977548|P1|Participant Flow|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
595406|NCT00980174|B3|Baseline|Total|Total of all reporting groups
594933|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594934|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594935|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594936|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594937|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594938|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594939|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594940|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594941|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594956|NCT00977470|B2|Baseline|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
594942|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594943|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594944|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594945|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594946|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594947|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594948|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594949|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594950|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594951|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594952|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594953|NCT00977379|E2|Reported Event|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
594954|NCT00977379|E1|Reported Event|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
594955|NCT00977470|B3|Baseline|Total|Total of all reporting groups
594957|NCT00977470|B1|Baseline|Erlotinib|Erlotinib: 150 mg taken orally once daily
594958|NCT00977470|P2|Participant Flow|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
594959|NCT00977470|P1|Participant Flow|Erlotinib|Erlotinib: 150 mg taken orally once daily
594960|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
594961|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
594962|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
594963|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
594964|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
594965|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
594966|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
594967|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
594968|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
594969|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
594970|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
594971|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
594972|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily
Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
594978|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
594979|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
594980|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
594981|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
594982|NCT00977548|E1|Reported Event|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
594983|NCT00977561|B3|Baseline|Total|Total of all reporting groups
594984|NCT00977561|B2|Baseline|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594985|NCT00977561|B1|Baseline|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Day 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594986|NCT00977561|P2|Participant Flow|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594987|NCT00977561|P1|Participant Flow|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 milligram/kilogram (mg/kg) administered intravenously (IV) over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 milligram/square meter (mg/m^2) IV over 1 hour or carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 5 milligram/milliliter*minute (mg/mL*min) IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594988|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594989|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594990|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594991|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594992|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594993|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594994|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594995|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594996|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595187|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
594997|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
594998|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Participants who received figitumumab, whether figitumumab (20 mg/kg, IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles) was given in combination with cisplatin (75 mg/m^2 IV over 1 hour on Day 1 of each cycle) or carboplatin (AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 of each cycle) followed by etoposide (100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle) from the beginning or figitumumab was given as a single agent after documented disease progression with cisplatin (or carboplatin) and etoposide. When given as a single agent, figitumumab was administered as IV infusion on Days 1 and 2 of the initial cycle and on Day 1 of subsequent cycles, up to 17 cycles in the absence of further disease progression or intolerable toxicity. Each cycle was 21 days cycle.
594999|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595000|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595001|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595002|NCT00977561|O1|Outcome|Figitumumab+ Cisplatin (or Carboplatin) + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595003|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595027|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595028|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595029|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595030|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
616960|NCT01032759|O2|Outcome|Placebo|"Placebo
Placebo: BID"
595004|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595005|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595006|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595007|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595008|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595009|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595010|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595011|NCT00977561|E2|Reported Event|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595012|NCT00977561|E1|Reported Event|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
595013|NCT00977613|B1|Baseline|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
595014|NCT00977613|P1|Participant Flow|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
595015|NCT00977613|O1|Outcome|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
595016|NCT00977613|E1|Reported Event|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
595017|NCT00977665|B3|Baseline|Total|Total of all reporting groups
595018|NCT00977665|B2|Baseline|Placebo|placebo tablet for up to 48 weeks.
595019|NCT00977665|B1|Baseline|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595020|NCT00977665|P2|Participant Flow|Placebo|placebo tablet for up to 48 weeks.
595021|NCT00977665|P1|Participant Flow|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595022|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595023|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595024|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595025|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595026|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595033|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595034|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595035|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595036|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595037|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595038|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595039|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595040|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595041|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595042|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595043|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595044|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595045|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595046|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595047|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595048|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
595049|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
595050|NCT00977665|E2|Reported Event|Rasagiline Mesylate|Rasagiline tablet, 1 mg/day for up to 48 weeks.
595051|NCT00977665|E1|Reported Event|Placebo|Placebo tablet for up to 48 weeks.
595052|NCT00979420|B5|Baseline|Total|Total of all reporting groups
595053|NCT00979420|B4|Baseline|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595054|NCT00979420|B3|Baseline|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595055|NCT00979420|B2|Baseline|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595056|NCT00979420|B1|Baseline|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595188|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
595057|NCT00979420|P4|Participant Flow|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595058|NCT00979420|P3|Participant Flow|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595059|NCT00979420|P2|Participant Flow|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|HIV RNA denotes Human immunodeficiency virus (HIV) Ribonucleic acid (RNA). Baseline reflects the last available documentation before start of treatment with Viramune
595060|NCT00979420|P1|Participant Flow|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595061|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595062|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595063|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595064|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595065|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595066|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595067|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595068|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595069|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595070|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595071|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595072|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595073|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595074|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595075|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595076|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595077|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595078|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595079|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595080|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595081|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595082|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595083|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595084|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595085|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595086|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595087|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595088|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595089|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595090|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595091|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595092|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595093|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595094|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595095|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595096|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595407|NCT00980174|B2|Baseline|Denosumab 60 mg Q6M|
595097|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595098|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595099|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595100|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595101|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595102|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595103|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595104|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
595105|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595106|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595107|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595108|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595109|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595110|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595111|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595112|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595113|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595114|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595115|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595116|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595117|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595118|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595119|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595120|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595121|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595122|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595123|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595124|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
595125|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
595126|NCT00979420|E1|Reported Event|Viramune|
595127|NCT00979459|B1|Baseline|All Participants|Includes participants who were randomized to receive either a single dose of four 20 mg MK-1006 DFC followed by a single dose of two 40 mg MK-1006 FCT or a single dose of four 20 mg MK-1006 FCT followed by a single dose of two 40 mg MK-1006 DFC
595128|NCT00979459|P2|Participant Flow|MK-1006 FCT, Then MK-1006 DFC|Participants received a single dose of two 40 mg film coated tablets (FCT) of MK-1006 followed by a single dose of four 20 mg MK-1006 dry filled capsules (DFC) after a 7 day washout period.
595129|NCT00979459|P1|Participant Flow|MK-1006 DFC, Then MK-1006 FCT|Participants received a single dose of four 20 mg MK-1006 dry filled capsules (DFC) followed by a single dose of two 40 mg MK-1006 film coated tablets (FCT) after a 7 day washout period.
595130|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
595131|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
595132|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
595133|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
595134|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg DFC
595135|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg FCT
595136|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg DFC
595137|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg FCT
595138|NCT00979459|E2|Reported Event|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
595189|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
595139|NCT00979459|E1|Reported Event|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
595140|NCT00979576|B4|Baseline|Total|Total of all reporting groups
595141|NCT00979576|B3|Baseline|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595142|NCT00979576|B2|Baseline|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595143|NCT00979576|B1|Baseline|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
595144|NCT00979576|P3|Participant Flow|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595145|NCT00979576|P2|Participant Flow|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595146|NCT00979576|P1|Participant Flow|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
595147|NCT00979576|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2 administered by intravenous infusion taken in combination with oral administration of BIBF 1120 100mg, 150mg or 200mg b.i.d..
595148|NCT00979576|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2 administered by intravenous infusion taken in combination with oral administration of BIBF 1120 100mg, 150mg or 200mg b.i.d..
595149|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595150|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595151|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
595152|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595153|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595190|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
595191|NCT00979615|E2|Reported Event|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
595192|NCT00979615|E1|Reported Event|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
595154|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
595155|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595156|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595157|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
595158|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595159|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595160|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
595161|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595209|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595892|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
595162|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595163|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
595164|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595165|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595166|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
595167|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595168|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595169|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
595170|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595171|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595172|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
595173|NCT00979576|E3|Reported Event|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595210|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595893|NCT00981292|O1|Outcome|135mg EGCG|All participants when consumed 135mg EGCG.
595174|NCT00979576|E2|Reported Event|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.
In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
595175|NCT00979576|E1|Reported Event|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
595176|NCT00979615|B3|Baseline|Total|Total of all reporting groups
595177|NCT00979615|B2|Baseline|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
595178|NCT00979615|B1|Baseline|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
595179|NCT00979615|P2|Participant Flow|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
595180|NCT00979615|P1|Participant Flow|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
595181|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
595182|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
595183|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
595184|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
595185|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
595186|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
595408|NCT00980174|B1|Baseline|Placebo|
595194|NCT00979628|B3|Baseline|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.
sliding scale regular insulin (SSRI) given subcut four-times daily before meals and at bedtime"
595195|NCT00979628|B2|Baseline|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Basal Plus : glargine once daily subcut at an initial dose of 0.15-0.25 units/kg/day plus corrective doses of glulisine subcut before meals and bedtime as needed"
595196|NCT00979628|B1|Baseline|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
Basal Bolus : glargine once daily plus glulisine before meals subcut at an initial dose of 0.3-0.5 unitws/kg/day (plus corrective doses of glulisine as needed)"
595197|NCT00979628|P3|Participant Flow|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.
sliding scale regular insulin (SSRI) : four-time daily in patients with T2DM admitted to general medicine and surgery wards."
595198|NCT00979628|P2|Participant Flow|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Basal Plus : glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
595199|NCT00979628|P1|Participant Flow|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
Basal Bolus : glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
595200|NCT00979628|O3|Outcome|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.
sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards."
595201|NCT00979628|O2|Outcome|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
595202|NCT00979628|O1|Outcome|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
595203|NCT00979628|E3|Reported Event|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.
sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards."
595204|NCT00979628|E2|Reported Event|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
595205|NCT00979628|E1|Reported Event|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
595206|NCT00979654|B1|Baseline|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595207|NCT00979654|P1|Participant Flow|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595208|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595258|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
595211|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595212|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595213|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595214|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595215|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595216|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595217|NCT00979654|E1|Reported Event|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
595233|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595234|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
595409|NCT00980174|P2|Participant Flow|Denosumab 60 mg Q6M|
595218|NCT00979875|B1|Baseline|Overall Study|"All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 3- to 14-day washout.
Intervention A: Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20) and a single, SC injection of 95 U/mL Lispro alone 3 to 14 days apart.
Intervention B: Participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Glulis alone 3 to 14 days apart.
Intervention C: Participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Aspart alone 3 to 14 days apart."
595219|NCT00979875|P6|Participant Flow|Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone."
595220|NCT00979875|P5|Participant Flow|Aspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received and a single, SC injection of 95 U/mL Glulisine alone.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20."
595221|NCT00979875|P4|Participant Flow|Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, Lispro|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.
After a 3- to 14-day washout, participants received a single, subcutaneous (SC) injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone."
595222|NCT00979875|P3|Participant Flow|Lispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20."
595223|NCT00979875|P2|Participant Flow|Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, Aspart|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone."
595259|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595224|NCT00979875|P1|Participant Flow|Lispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20."
595225|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595226|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
595227|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595228|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
595229|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595230|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
595231|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595232|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
595306|NCT00979940|E1|Reported Event|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
595235|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595236|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
595237|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595238|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
595239|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595240|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
595241|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595242|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
595243|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595244|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
595245|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595246|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
595247|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595248|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
595249|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595250|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
595251|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595252|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
595253|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595254|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
595255|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595256|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
595257|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595260|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
595261|NCT00979875|E6|Reported Event|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595262|NCT00979875|E5|Reported Event|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
595263|NCT00979875|E4|Reported Event|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595264|NCT00979875|E3|Reported Event|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
595265|NCT00979875|E2|Reported Event|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
595266|NCT00979875|E1|Reported Event|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
595267|NCT00979901|B5|Baseline|Total|Total of all reporting groups
595268|NCT00979901|B4|Baseline|Montelukast/Loratadine|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
595269|NCT00979901|B3|Baseline|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595270|NCT00979901|B2|Baseline|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595271|NCT00979901|B1|Baseline|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
595307|NCT00979953|B5|Baseline|Total|Total of all reporting groups
595308|NCT00979953|B4|Baseline|Placebo|Four placebo capsules administered orally BID for 14 days
595272|NCT00979901|P4|Participant Flow|Montelukast/Loratadine|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
595273|NCT00979901|P3|Participant Flow|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595274|NCT00979901|P2|Participant Flow|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595275|NCT00979901|P1|Participant Flow|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
595276|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595277|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595278|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
595279|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595280|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595281|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
595282|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595283|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595284|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
595285|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595286|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595287|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
595288|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595289|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595290|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
595291|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595292|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595293|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
595294|NCT00979901|E4|Reported Event|Montelukast 10 mg + Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
595295|NCT00979901|E3|Reported Event|Loratadine 10mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595296|NCT00979901|E2|Reported Event|Montelukast 10mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
595297|NCT00979901|E1|Reported Event|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
595298|NCT00979940|B3|Baseline|Total|Total of all reporting groups
595299|NCT00979940|B2|Baseline|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab
Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
595300|NCT00979940|B1|Baseline|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
595301|NCT00979940|P2|Participant Flow|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab
Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
595302|NCT00979940|P1|Participant Flow|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
595303|NCT00979940|O2|Outcome|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab
Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
595304|NCT00979940|O1|Outcome|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
595305|NCT00979940|E2|Reported Event|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab
Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
595309|NCT00979953|B3|Baseline|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4
One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14"
595310|NCT00979953|B2|Baseline|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
595311|NCT00979953|B1|Baseline|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
595312|NCT00979953|P4|Participant Flow|Placebo|Four placebo capsules administered orally BID for 14 days
595313|NCT00979953|P3|Participant Flow|Oxycodone CR|One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsules administered orally BID Days 1 through 4 One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14
595314|NCT00979953|P2|Participant Flow|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
595315|NCT00979953|P1|Participant Flow|ADL5859|One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days
595316|NCT00979953|O4|Outcome|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
595317|NCT00979953|O3|Outcome|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
595318|NCT00979953|O2|Outcome|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4
One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID for Days 5 through 14"
595319|NCT00979953|O1|Outcome|Placebo|Four placebo capsules administered orally BID for 14 days
595320|NCT00979953|E4|Reported Event|Placebo|Four placebo capsules administered orally BID for 14 days
595321|NCT00979953|E3|Reported Event|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4
One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14"
595322|NCT00979953|E2|Reported Event|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
595323|NCT00979953|E1|Reported Event|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
595324|NCT00979992|B1|Baseline|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
595325|NCT00979992|P1|Participant Flow|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
595326|NCT00979992|O1|Outcome|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
595327|NCT00979992|O1|Outcome|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
595328|NCT00979992|O1|Outcome|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
595329|NCT00979992|O1|Outcome|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
595330|NCT00979992|O1|Outcome|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
595331|NCT00979992|E1|Reported Event|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
595333|NCT00980005|B2|Baseline|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595334|NCT00980005|B1|Baseline|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595335|NCT00980005|P2|Participant Flow|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595336|NCT00980005|P1|Participant Flow|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595337|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595338|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595339|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595340|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595410|NCT00980174|P1|Participant Flow|Placebo|
595341|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595342|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595343|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595344|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595345|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595346|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595347|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595348|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595349|NCT00980005|O4|Outcome|Fluzone 5 Years of Age and Older Group|Subjects aged 5 years and above and who received 1 or 2 injections of Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age
595350|NCT00980005|O3|Outcome|Flulaval 5 Years of Age and Older Group|Subjects aged 5 years and above and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
595351|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595352|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595353|NCT00980005|O4|Outcome|Fluzone Les Than 5 Years Old Group|Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age
595354|NCT00980005|O3|Outcome|Flulaval Less Than 5 Years Old Group|Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
595379|NCT00980044|P3|Participant Flow|Tramadol 600 mg Daily|Medication: Extended release tramadol 600 mg daily given for 1 week followed by 1 week of placebo dosing.
595380|NCT00980044|P2|Participant Flow|Placebo|Placebo given for two weeks
595355|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595356|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595357|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595358|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595359|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595360|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595361|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595362|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595363|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595364|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595365|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595366|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595367|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595368|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595369|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595370|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595371|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595372|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595373|NCT00980005|E2|Reported Event|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
595374|NCT00980005|E1|Reported Event|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:
3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
595375|NCT00980044|B4|Baseline|Total|Total of all reporting groups
595376|NCT00980044|B3|Baseline|Tramadol 600 mg|Medication: Extended release tramadol 600 mg given for 1 week and then placebo given for 1 week
595377|NCT00980044|B2|Baseline|Placebo|Medication: Placebo given for two weeks
595378|NCT00980044|B1|Baseline|Tramadol 200 mg|Medication: Extended release tramadol for 1 week and then placebo given for 1 week
595381|NCT00980044|P1|Participant Flow|Tramadol 200 mg Daily|Medication: Extended release tramadol 200 mg daily given for 1 week then placebo given for 1 week
595382|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week
Tramadol: Oral Medication"
595383|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication
Placebo: Oral Medication"
595384|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week
Tramadol: Oral Medication"
595385|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week
Tramadol: Oral Medication"
595386|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication
Placebo: Oral Medication"
595387|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week
Tramadol: Oral Medication"
595388|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week
Tramadol: Oral Medication"
595389|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication
Placebo: Oral Medication"
595390|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week
Tramadol: Oral Medication"
595391|NCT00980044|O3|Outcome|Tramadol 600 mg Daily|Medication: Extended release tramadol
595392|NCT00980044|O2|Outcome|Placebo|Medication
595393|NCT00980044|O1|Outcome|Tramadol 200 mg Daily|Medication: Extended release tramadol
595394|NCT00980044|E3|Reported Event|Tramadol 600 mg|Medication: Extended release tramadol 600 mg daily for one week followed by placebo for one week
595395|NCT00980044|E2|Reported Event|Placebo|Medication: Placebo for 2 weeks
595396|NCT00980044|E1|Reported Event|Tramadol 200 mg|Medication: Extended release tramadol 200 mg daily for one week followed by placebo for one week
595397|NCT00980148|B3|Baseline|Total|Total of all reporting groups
595398|NCT00980148|B2|Baseline|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
595399|NCT00980148|B1|Baseline|Azithromycin Arm|Azithromycin 1 gm oral single dose
595400|NCT00980148|P2|Participant Flow|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
595401|NCT00980148|P1|Participant Flow|Azithromycin Arm|Azithromycin 1 gm oral single dose
595424|NCT00980174|E1|Reported Event|Placebo|
595425|NCT00980200|B1|Baseline|PB, GW642444 6.25 µg QD, 6.25 µg BID, 12.5 µg QD, and 25 µg QD|All participants received one of the following five treatments in one of the five Treatment Periods from two DPI dispensed on Day 1of each of the five 7-day treatment periods: Placebo (PB), GW642444 6.25 µg once daily (QD) in the evening, GW642444 6.25 µg twice daily (BID), GW642444 12.5 µg QD in the evening, and GW642444 25 µg QD in the evening. Participants received their first evening medication dose in the clinic on Day 1 of each of the five treatment periods. The treatments were administered in the morning (AM) and in the evening (PM), approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a 7-day washout period.
595426|NCT00980200|P5|Participant Flow|Sequence 5: 25 µg QD, 12.5 µg QD, 6.25 µg BID, 6.25 µg QD, Pbo|Participants received GW642444 25 µg QD in the evening, GW642444 12.5 µg QD in the evening, GW642444 6.25 µg BID, GW642444 6.25 µg QD in the evening, and placebo in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
595427|NCT00980200|P4|Participant Flow|Sequence 4: 12.5 µg QD, 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID|Participants received GW642444 12.5 µg QD in the evening, GW642444 6.25 µg QD in the evening, GW642444 25 µg QD in the evening, placebo, and GW642444 6.25 µg BID and in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
595428|NCT00980200|P3|Participant Flow|Sequence 3: 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID, 12.5 µg QD|Participants received GW642444 6.25 µg QD in the evening, GW642444 25 µg QD in the evening, placebo, GW642444 6.25 µg BID, and GW642444 12.5 µg QD in the evening in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
595510|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595429|NCT00980200|P2|Participant Flow|Sequence 2: Pbo, 6.25 µg BID, 6.25 µg QD, 12.5 µg QD, 25 µg QD|Participants received placebo, GW642444 6.25 µg BID, GW642444 6.25 µg QD in the evening, GW642444 12.5 µg QD in the evening, and GW642444 25 µg QD in the evening and in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
595430|NCT00980200|P1|Participant Flow|Sequence 1: 6.25 µg BID, Pbo, 12.5 µg QD, 25 µg QD, 6.25 µg QD|Participants received GW642444 6.25 micrograms (µg) twice a day (BID), placebo (pbo), GW642444 12.5 µg once a day (QD) in the evening, GW642444 25 µg QD in the evening, and GW642444 6.25 µg QD in the evening in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a Dry Powder Inhaler (DPI) for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
595431|NCT00980200|O5|Outcome|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595432|NCT00980200|O4|Outcome|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595433|NCT00980200|O3|Outcome|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595434|NCT00980200|O2|Outcome|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595435|NCT00980200|O1|Outcome|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
595490|NCT00980330|O7|Outcome|All TMC435|Participants in all 6 TMC435 treatment groups combined.
595491|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595564|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595436|NCT00980200|O5|Outcome|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595437|NCT00980200|O4|Outcome|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595438|NCT00980200|O3|Outcome|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595439|NCT00980200|O2|Outcome|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595440|NCT00980200|O1|Outcome|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
595441|NCT00980200|E5|Reported Event|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595474|NCT00980330|P4|Participant Flow|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595622|NCT00980655|B3|Baseline|Total|Total of all reporting groups
595442|NCT00980200|E4|Reported Event|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595443|NCT00980200|E3|Reported Event|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595444|NCT00980200|E2|Reported Event|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
595445|NCT00980200|E1|Reported Event|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
595446|NCT00980278|B3|Baseline|Total|Total of all reporting groups
595447|NCT00980278|B2|Baseline|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant
Aastrom BRCs: sinus augmentation, BRC application, dental implant"
595448|NCT00980278|B1|Baseline|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: N/A; only sinus augmentation and dental implant
Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
595492|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595493|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595857|NCT00981227|O3|Outcome|ESL 1600 mg/Day|total daily dose;oral route
595449|NCT00980278|P2|Participant Flow|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant
Aastrom BRCs: sinus augmentation, BRC application, dental implant"
595450|NCT00980278|P1|Participant Flow|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: N/A; only sinus augmentation and dental implant
Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
595451|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant
Aastrom BRCs: sinus augmentation, BRC application, dental implant"
595452|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: N/A; only sinus augmentation and dental implant
Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
595453|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant
Aastrom BRCs: sinus augmentation, BRC application, dental implant"
595454|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: N/A; only sinus augmentation and dental implant
Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
595475|NCT00980330|P3|Participant Flow|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595455|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant
Aastrom BRCs: sinus augmentation, BRC application, dental implant"
595456|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: N/A; only sinus augmentation and dental implant
Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
595457|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant
Aastrom BRCs: sinus augmentation, BRC application, dental implant"
595458|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: N/A; only sinus augmentation and dental implant
Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
595459|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant
Aastrom BRCs: sinus augmentation, BRC application, dental implant"
595494|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595460|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: N/A; only sinus augmentation and dental implant
Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
595461|NCT00980278|E2|Reported Event|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant
Aastrom BRCs: sinus augmentation, BRC application, dental implant"
595462|NCT00980278|E1|Reported Event|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.
Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
Biological/Vaccine: N/A; only sinus augmentation and dental implant
Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
595463|NCT00980330|B8|Baseline|Total|Total of all reporting groups
595464|NCT00980330|B7|Baseline|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595465|NCT00980330|B6|Baseline|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595466|NCT00980330|B5|Baseline|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595467|NCT00980330|B4|Baseline|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595468|NCT00980330|B3|Baseline|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595469|NCT00980330|B2|Baseline|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595470|NCT00980330|B1|Baseline|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595471|NCT00980330|P7|Participant Flow|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595472|NCT00980330|P6|Participant Flow|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595473|NCT00980330|P5|Participant Flow|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
616961|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
595476|NCT00980330|P2|Participant Flow|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595477|NCT00980330|P1|Participant Flow|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595478|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595479|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595480|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595481|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595482|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595483|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595484|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595485|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595486|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595487|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595488|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595489|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595495|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595496|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595497|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595498|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595499|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595500|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595501|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595502|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595503|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595504|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595505|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595506|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595507|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595508|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595509|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595511|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595512|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595513|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595514|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595515|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595516|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595517|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595518|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595519|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595520|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595521|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595522|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595523|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595524|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595525|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595526|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595527|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595528|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595529|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595530|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595531|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595532|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595533|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595534|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595535|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595536|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595537|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595538|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595539|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595540|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595541|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595542|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595543|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595544|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595545|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595546|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595547|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595548|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595549|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595550|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595551|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595552|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595553|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595554|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595555|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595556|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595557|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595558|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595559|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595560|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595561|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595562|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595563|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595565|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595566|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595567|NCT00980330|E7|Reported Event|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595568|NCT00980330|E6|Reported Event|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595569|NCT00980330|E5|Reported Event|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
595570|NCT00980330|E4|Reported Event|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
595571|NCT00980330|E3|Reported Event|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
595572|NCT00980330|E2|Reported Event|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
595573|NCT00980330|E1|Reported Event|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
595574|NCT00980343|B3|Baseline|Total|Total of all reporting groups
595575|NCT00980343|B2|Baseline|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
595623|NCT00980655|B2|Baseline|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595576|NCT00980343|B1|Baseline|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
595577|NCT00980343|P2|Participant Flow|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
595578|NCT00980343|P1|Participant Flow|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
595579|NCT00980343|O1|Outcome|Arm 1(Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery.
Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
595580|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
595581|NCT00980343|O1|Outcome|Arm 1(Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery.
Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
595582|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
595601|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope
Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
595602|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope
Airway Scope: Tracheal intubation by Airway Scope"
595858|NCT00981227|O2|Outcome|ESL 1200 mg/Day|total daily dose;oral route
595583|NCT00980343|O1|Outcome|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
595584|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
595585|NCT00980343|O1|Outcome|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
595586|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
595587|NCT00980343|O1|Outcome|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
595588|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
616962|NCT01032759|O2|Outcome|Placebo|"Placebo
Placebo: BID"
595589|NCT00980343|O1|Outcome|Arm 1(Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery.
Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
595590|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
595591|NCT00980343|O1|Outcome|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
595592|NCT00980343|E2|Reported Event|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies"
595593|NCT00980343|E1|Reported Event|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies"
595594|NCT00980590|B3|Baseline|Total|Total of all reporting groups
595595|NCT00980590|B2|Baseline|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope
Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
595596|NCT00980590|B1|Baseline|Airway Scope|"Intubation with Airway Scope
Airway Scope: Tracheal intubation by Airway Scope"
595597|NCT00980590|P2|Participant Flow|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope
Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
595598|NCT00980590|P1|Participant Flow|Airway Scope|"Intubation with Airway Scope
Airway Scope: Tracheal intubation by Airway Scope"
595599|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope
Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
595600|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope
Airway Scope: Tracheal intubation by Airway Scope"
595859|NCT00981227|O1|Outcome|Placebo|"placebo
Placebo : oral route"
595603|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope
Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
595604|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope
Airway Scope: Tracheal intubation by Airway Scope"
595605|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope
Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
595606|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope
Airway Scope: Tracheal intubation by Airway Scope"
595607|NCT00980590|E2|Reported Event|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope
Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
595608|NCT00980590|E1|Reported Event|Airway Scope|"Intubation with Airway Scope
Airway Scope: Tracheal intubation by Airway Scope"
595609|NCT00980642|B3|Baseline|Total|Total of all reporting groups
595610|NCT00980642|B2|Baseline|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
595611|NCT00980642|B1|Baseline|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
595612|NCT00980642|P2|Participant Flow|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
595613|NCT00980642|P1|Participant Flow|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
595614|NCT00980642|O2|Outcome|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
595615|NCT00980642|O1|Outcome|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
595616|NCT00980642|O2|Outcome|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
595617|NCT00980642|O1|Outcome|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
595618|NCT00980642|O2|Outcome|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
595619|NCT00980642|O1|Outcome|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery
595620|NCT00980642|E2|Reported Event|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
595621|NCT00980642|E1|Reported Event|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
595624|NCT00980655|B1|Baseline|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595625|NCT00980655|P2|Participant Flow|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595626|NCT00980655|P1|Participant Flow|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595627|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595628|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595629|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595630|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595631|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595632|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595860|NCT00981227|O6|Outcome|Placebo|total daily dose;oral route
595633|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595634|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595635|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595636|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595637|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595638|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595639|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595676|NCT00980681|E1|Reported Event|Dotarem|"Each subject will receive one injection of Dotarem 0.2ml/kg.
Dotarem: Each subject will receive one injection of Dotarem 0.2ml/kg"
595677|NCT00980746|B7|Baseline|Total|Total of all reporting groups
595640|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595641|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595642|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595643|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595644|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595645|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595646|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595647|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595648|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595861|NCT00981227|O5|Outcome|ESL 800 mg Twice Daily|total daily dose;oral route
595649|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595650|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595651|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595652|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595653|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595654|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595655|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595678|NCT00980746|B6|Baseline|Placebo|"Placebo
Placebo : oral route"
595679|NCT00980746|B5|Baseline|ESL 800 mg QD|"ESL 800 mg once-daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
596713|NCT00983853|O2|Outcome|ATV/R-based (Test, N=13) vs No HAART (Reference, N=7)|
595656|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595657|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595658|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595659|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595660|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595661|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595662|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595663|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595699|NCT00980746|E3|Reported Event|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595862|NCT00981227|O4|Outcome|ESL 800 mg Once-daily|total daily dose;oral route
595863|NCT00981227|O3|Outcome|ESL 600 mg Twice Daily|total daily dose;oral route
595664|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595665|NCT00980655|O1|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
595666|NCT00980655|E5|Reported Event|Follow-up|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from blood draw 1 month after 23vPS Dose to 6-month follow-up.
595667|NCT00980655|E4|Reported Event|23vPS Dose|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from 23vPS Dose to the blood draw 1 month after 23vPS Dose.
595668|NCT00980655|E3|Reported Event|13vPnC Dose 4|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from 13vPnC Dose 4 to the blood draw 1 month after 13vPnC Dose 4.
595669|NCT00980655|E2|Reported Event|13vPnC Dose 3 Blood Draw to 13vPnC Dose 4|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from blood draw 1 month after 13vPnC Dose 3 to prior to administration of 13vPnC Dose 4.
595670|NCT00980655|E1|Reported Event|13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw|All participants aged 2 years and above who received 3 single 0.5 mL doses of 13vPnC intramuscular injections at 1-month intervals, were assessed from 13vPnC Dose 1 to the blood draw 1 month after 13vPnC Dose 3.
595671|NCT00980681|B1|Baseline|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
595672|NCT00980681|P1|Participant Flow|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
595673|NCT00980681|O2|Outcome|Time-Of-Flight MRA|Patients benefiting from an MRA with no injection of contrast medium
595674|NCT00980681|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after administration with Dotarem
595675|NCT00980681|E2|Reported Event|Time Of Flight|"Each subject will undergo a TOF Magnetic Resonance Angiography
Time of Flight: Each subject will undergo a TOF MRA"
595719|NCT00980980|P1|Participant Flow|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
595680|NCT00980746|B4|Baseline|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595681|NCT00980746|B3|Baseline|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595682|NCT00980746|B2|Baseline|ESL 400 mg BD|"ESL 400 mg twice daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595683|NCT00980746|B1|Baseline|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595684|NCT00980746|P6|Participant Flow|Placebo|"Placebo
Placebo : oral route"
595685|NCT00980746|P5|Participant Flow|ESL 800 mg QD|"ESL 800 mg once-daily
ESL tablets, scored to allow dose titration during the titration period."
595686|NCT00980746|P4|Participant Flow|ESL 800 mg BID|"ESL 800 mg twice daily
ESL tablets, scored to allow dose titration during the titration period."
595687|NCT00980746|P3|Participant Flow|ESL 600 mg BID|"ESL 600 mg twice daily
ESL tablets, scored to allow dose titration during the titration period."
595688|NCT00980746|P2|Participant Flow|ESL 400 mg BD|"ESL 400 mg twice daily
ESL tablets, scored to allow dose titration during the titration period."
595689|NCT00980746|P1|Participant Flow|ESL 1200 mg QD|Eslicarbazepine acetate (ESL) 1200 mg once daily. ESL tablets, scored to allow dose titration during the titration period.
595690|NCT00980746|O6|Outcome|Placebo|"Placebo
Placebo : oral route"
595691|NCT00980746|O5|Outcome|ESL 800 mg QD|"ESL 800 mg once-daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595692|NCT00980746|O4|Outcome|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595693|NCT00980746|O3|Outcome|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595694|NCT00980746|O2|Outcome|ESL 400 mg BD|"ESL 400 mg twice daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595695|NCT00980746|O1|Outcome|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595696|NCT00980746|E6|Reported Event|Placebo|"Placebo
Placebo : oral route"
595697|NCT00980746|E5|Reported Event|ESL 800 mg QD|"ESL 800 mg once-daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595698|NCT00980746|E4|Reported Event|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595864|NCT00981227|O2|Outcome|ESL 400 mg Twice-daily|total daily dose;oral route
595700|NCT00980746|E2|Reported Event|ESL 400 mg BD|"ESL 400 mg twice daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595701|NCT00980746|E1|Reported Event|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily
Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
595702|NCT00980798|B3|Baseline|Total|Total of all reporting groups
595703|NCT00980798|B2|Baseline|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
595704|NCT00980798|B1|Baseline|Placebo|Placebo daily for 16 weeks
595705|NCT00980798|P2|Participant Flow|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
595706|NCT00980798|P1|Participant Flow|Placebo|Placebo daily for 16 weeks
595707|NCT00980798|O2|Outcome|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
595708|NCT00980798|O1|Outcome|Placebo|Placebo daily for 16 weeks
595709|NCT00980798|O2|Outcome|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
595710|NCT00980798|O1|Outcome|Placebo|Placebo daily for 16 weeks
595711|NCT00980798|E2|Reported Event|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
595712|NCT00980798|E1|Reported Event|Placebo|Placebo daily for 16 weeks
595713|NCT00980980|B4|Baseline|Total|Total of all reporting groups
595714|NCT00980980|B3|Baseline|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595715|NCT00980980|B2|Baseline|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595716|NCT00980980|B1|Baseline|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
595717|NCT00980980|P3|Participant Flow|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595718|NCT00980980|P2|Participant Flow|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595762|NCT00981058|B3|Baseline|Total|Total of all reporting groups
595720|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595721|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595722|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
595723|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595724|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595725|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
595726|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595727|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595728|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
595729|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595730|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595731|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
595732|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595733|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595734|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
595735|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595736|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595737|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
595738|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595739|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
616963|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
595740|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
595741|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595742|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595743|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
595744|NCT00980980|E3|Reported Event|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595745|NCT00980980|E2|Reported Event|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
595746|NCT00980980|E1|Reported Event|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs Contact Precautions for MRSA+
595747|NCT00981019|B1|Baseline|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
595771|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595793|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
595865|NCT00981227|O1|Outcome|ESL 1200 mg Once Daily|total daily dose;oral route
595748|NCT00981019|P1|Participant Flow|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
595749|NCT00981019|O1|Outcome|Mortality*Incidence*5-year Survival*Early Detection Rate|The survey introduced four different cancer statistics in scenarios about 2 different screening tests. To mask the fact that all statistics stemmed from prostate cancer screening, screening in the scenarios were labeled “X” and “Z”. The survey then introduced test Z, whose effectiveness was described in terms of a reduction of cancer mortality. After responding to the series of outcome questions about test Z, physicians received additional information on the cancer incidence, again followed by the outcome questions. In the next scenario, the survey introduced test X, whose effectiveness was described in terms of an increase in 5-year survival and, in the next step, with additional information on early detection rates. After each step, doctors had to respond to the same outcome questions as they had for test Z. Please not, information on test X and test Z were randomly presented to control for order effects.
595750|NCT00981019|E1|Reported Event|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
595751|NCT00981045|B3|Baseline|Total|Total of all reporting groups
595752|NCT00981045|B2|Baseline|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
595753|NCT00981045|B1|Baseline|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
595754|NCT00981045|P2|Participant Flow|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
595755|NCT00981045|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
595756|NCT00981045|O2|Outcome|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
595757|NCT00981045|O1|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
595758|NCT00981045|O2|Outcome|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
595759|NCT00981045|O1|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
595760|NCT00981045|E2|Reported Event|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
595761|NCT00981045|E1|Reported Event|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
595763|NCT00981058|B2|Baseline|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595764|NCT00981058|B1|Baseline|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595765|NCT00981058|P2|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595766|NCT00981058|P1|Participant Flow|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595767|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595768|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595769|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595770|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595772|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595773|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595774|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595775|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595776|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595777|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595778|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595779|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595780|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595781|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595782|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595783|NCT00981058|E2|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595784|NCT00981058|E1|Reported Event|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles."
595785|NCT00981084|B3|Baseline|Total|Total of all reporting groups
595786|NCT00981084|B2|Baseline|Placebo Then Armodafinil|
595787|NCT00981084|B1|Baseline|Armodafinil Then Placebo|"All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design
armodafinil : Half of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions."
595788|NCT00981084|P2|Participant Flow|Placebo First and Armodafinil Second|Patients randomly assigned to this condition received a placebo in the first treatment period. There was then a one week washout period. They then received 250 mg armodafinil in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
595789|NCT00981084|P1|Participant Flow|Armodafinil First and Placebo Second|Patients randomly assigned to this condition received a 250 mg dose of armodafinil in the first treatment period. There was then a one week washout period. They received a placebo in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
595790|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
595791|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
595792|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
595854|NCT00981227|P2|Participant Flow|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily
Eslicarbazepine acetate : Scored tablets"
595794|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
595795|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
595796|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
595797|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
595798|NCT00981084|E4|Reported Event|Armodafinil Then Placebo (Placebo)|number of adverse events following placebo in the armodafniil then placebo condition.
595799|NCT00981084|E3|Reported Event|Placebo Then Armodafinil (Armodafinil)|Adverse events following armodafinil in the placebo/armodafinil group
595800|NCT00981084|E2|Reported Event|Armodafinil Then Placebo (Armodafinil)|Adverse events reported after taking armodafinil in the Armodafinil then placebo group
595801|NCT00981084|E1|Reported Event|Placebo Then Armodafinil (Placebo)|Adverse events reported after taking placebo in the Placebo then Armodafinil Group
595802|NCT00981175|B4|Baseline|Total|Total of all reporting groups
595803|NCT00981175|B3|Baseline|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
595804|NCT00981175|B2|Baseline|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
595805|NCT00981175|B1|Baseline|ChimeriVax™-JE Vaccine First , Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
595806|NCT00981175|P2|Participant Flow|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on day 28.
595807|NCT00981175|P1|Participant Flow|ChimeriVax™-JE Vaccine First, Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on day 28.
595808|NCT00981175|O3|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at month 6 following primary ChimeriVax™-JE and Diluent vaccination at Day 0 and Day 28
595809|NCT00981175|O2|Outcome|Placebo Vaccine|Participants received a dose of placebo vaccine (diluent) at either Day 0 or Day 28
595810|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine|Participants received a primary dose of ChimeriVax™-JE vaccine at either Day 0 or Day 28
595811|NCT00981175|O3|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
595812|NCT00981175|O2|Outcome|Placebo Vaccine|Participants received a dose of placebo vaccine (diluent)at either Day 0 or Day 28
595813|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine|Participants received a primary dose of ChimeriVax™-JE vaccine at either Day 0 or Day 28
595814|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
595815|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
595816|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
595817|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
595818|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
595819|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
595820|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
595821|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
595822|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
595823|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
595824|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
595825|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
595826|NCT00981175|E3|Reported Event|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
595827|NCT00981175|E2|Reported Event|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
595828|NCT00981175|E1|Reported Event|ChimeriVax™-JE Vaccine First , Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
595829|NCT00981214|B1|Baseline|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595830|NCT00981214|P1|Participant Flow|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595855|NCT00981227|P1|Participant Flow|ESL 1200 mg Once Daily|"ESL 1200 mg once daily
Eslicarbazepine acetate : Scored tablets"
595856|NCT00981227|O4|Outcome|ESL 800 mg/Day|total daily dose;oral route
595831|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595832|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595833|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595834|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595835|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595836|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595837|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595838|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595888|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
595889|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
595890|NCT00981292|O1|Outcome|135mg|All participants when consumed 135mg EGCG.
595891|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
595839|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595840|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595841|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595842|NCT00981214|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in capsule was administered orally or sprinkled on food. When required, from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
595843|NCT00981227|B7|Baseline|Total|Total of all reporting groups
595844|NCT00981227|B6|Baseline|Placebo|"placebo
Placebo : oral route"
595845|NCT00981227|B5|Baseline|ESL 800 mg Twice Daily|"ESL 800 mg twice daily
Eslicarbazepine acetate : Scored tablets"
595846|NCT00981227|B4|Baseline|ESL 800 mg Once-daily|"ESL 800 mg once-daily
Eslicarbazepine acetate : Scored tablets"
595847|NCT00981227|B3|Baseline|ESL 600 mg Twice Daily|"ESL 600 mg twice daily
Eslicarbazepine acetate : Scored tablets"
595848|NCT00981227|B2|Baseline|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily
Eslicarbazepine acetate : Scored tablets"
595849|NCT00981227|B1|Baseline|ESL 1200 mg Once Daily|"ESL 1200 mg once daily
Eslicarbazepine acetate : Scored tablets"
595850|NCT00981227|P6|Participant Flow|Placebo|"placebo
Placebo : oral route"
595851|NCT00981227|P5|Participant Flow|ESL 800 mg Twice Daily|"ESL 800 mg twice daily
Eslicarbazepine acetate : Scored tablets"
595852|NCT00981227|P4|Participant Flow|ESL 800 mg Once-daily|"ESL 800 mg once-daily
Eslicarbazepine acetate : Scored tablets"
595853|NCT00981227|P3|Participant Flow|ESL 600 mg Twice Daily|"ESL 600 mg twice daily
Eslicarbazepine acetate : Scored tablets"
595866|NCT00981227|E6|Reported Event|Placebo|"placebo
Placebo : oral route"
595867|NCT00981227|E5|Reported Event|ESL 800 mg Twice Daily|"ESL 800 mg twice daily
Eslicarbazepine acetate : Scored tablets"
595868|NCT00981227|E4|Reported Event|ESL 800 mg Once-daily|"ESL 800 mg once-daily
Eslicarbazepine acetate : Scored tablets"
595869|NCT00981227|E3|Reported Event|ESL 600 mg Twice Daily|"ESL 600 mg twice daily
Eslicarbazepine acetate : Scored tablets"
595870|NCT00981227|E2|Reported Event|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily
Eslicarbazepine acetate : Scored tablets"
595871|NCT00981227|E1|Reported Event|ESL 1200 mg Once Daily|"ESL 1200 mg once daily
Eslicarbazepine acetate : Scored tablets"
595872|NCT00981292|B7|Baseline|Total|Total of all reporting groups
595873|NCT00981292|B6|Baseline|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
595874|NCT00981292|B5|Baseline|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
595875|NCT00981292|B4|Baseline|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
595876|NCT00981292|B3|Baseline|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
595877|NCT00981292|B2|Baseline|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
595878|NCT00981292|B1|Baseline|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
595879|NCT00981292|P6|Participant Flow|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
595880|NCT00981292|P5|Participant Flow|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
595881|NCT00981292|P4|Participant Flow|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
595882|NCT00981292|P3|Participant Flow|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
595883|NCT00981292|P2|Participant Flow|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
595884|NCT00981292|P1|Participant Flow|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
595885|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
595886|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
595887|NCT00981292|O1|Outcome|135mg EGCG|All participants when consumed 135mg EGCG.
595894|NCT00981292|E6|Reported Event|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
595895|NCT00981292|E5|Reported Event|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
595896|NCT00981292|E4|Reported Event|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
595897|NCT00981292|E3|Reported Event|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
595898|NCT00981292|E2|Reported Event|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
595899|NCT00981292|E1|Reported Event|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
595900|NCT00981305|B3|Baseline|Total|Total of all reporting groups
595901|NCT00981305|B2|Baseline|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595902|NCT00981305|B1|Baseline|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595903|NCT00981305|P2|Participant Flow|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595904|NCT00981305|P1|Participant Flow|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595905|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595906|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595907|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595908|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595909|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595910|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595911|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595912|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595913|NCT00981305|E2|Reported Event|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595914|NCT00981305|E1|Reported Event|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
595915|NCT00981370|B1|Baseline|Group 1|First group of subjects to be enrolled.
595916|NCT00981370|P1|Participant Flow|Group One|No enrollment
595917|NCT00981370|O1|Outcome|Group 1|First group of subjects enrolled.
595918|NCT00981370|E1|Reported Event|Group 1|No patients enrolled
595919|NCT00981409|B3|Baseline|Total|Total of all reporting groups
595920|NCT00981409|B2|Baseline|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
595921|NCT00981409|B1|Baseline|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
596028|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
595922|NCT00981409|P2|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
595923|NCT00981409|P1|Participant Flow|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
595924|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
595925|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
595926|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
595927|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
595928|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
595929|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
595930|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
595966|NCT00981630|P4|Participant Flow|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
595931|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
595932|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
595933|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
595934|NCT00981409|E2|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
595935|NCT00981409|E1|Reported Event|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
595936|NCT00981435|B4|Baseline|Total|Total of all reporting groups
595937|NCT00981435|B3|Baseline|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
595938|NCT00981435|B2|Baseline|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
595939|NCT00981435|B1|Baseline|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
595940|NCT00981435|P3|Participant Flow|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
595941|NCT00981435|P2|Participant Flow|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
595942|NCT00981435|P1|Participant Flow|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
595943|NCT00981435|O3|Outcome|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
595944|NCT00981435|O2|Outcome|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
595945|NCT00981435|O1|Outcome|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
595946|NCT00981435|O3|Outcome|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
595947|NCT00981435|O2|Outcome|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
595948|NCT00981435|O1|Outcome|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
595949|NCT00981435|E3|Reported Event|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
595950|NCT00981435|E2|Reported Event|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
595951|NCT00981435|E1|Reported Event|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
595952|NCT00981461|B3|Baseline|Total|Total of all reporting groups
595953|NCT00981461|B2|Baseline|Control Device|This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full length of study. This arm of the study was blinded and dispensed to subjects on a random basis.
595954|NCT00981461|B1|Baseline|HairMax LaserComb 2009 9 Beam|This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full length of study. This device was distributed to subjects in a blinded randomized manner
595955|NCT00981461|P2|Participant Flow|Control Device|This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full 26 duration of study. This arm of the study was blinded and dispensed to subjects on a random basis.Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
595956|NCT00981461|P1|Participant Flow|HairMax LaserComb 2009 9 Beam|This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full 26 duration of the study. This device was distributed to subjects in a blinded randomized manner. Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
595957|NCT00981461|O2|Outcome|HairMax LaserComb 2009 9 Beam|This device is the active device with 9 laser modules
595958|NCT00981461|O1|Outcome|Control Device|This control device is inactive emitting white light
595959|NCT00981461|E2|Reported Event|HairMax LaserComb 2009 9 Beam|This device is the active device with 9 laser modules
595960|NCT00981461|E1|Reported Event|Control Device|This control device is inactive emitting white light
595961|NCT00981630|B5|Baseline|Total|Total of all reporting groups
595962|NCT00981630|B4|Baseline|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
595963|NCT00981630|B3|Baseline|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
595964|NCT00981630|B2|Baseline|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
595965|NCT00981630|B1|Baseline|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
595967|NCT00981630|P3|Participant Flow|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
595968|NCT00981630|P2|Participant Flow|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
595969|NCT00981630|P1|Participant Flow|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
595970|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
595971|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
595972|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
595973|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
595974|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
595975|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
595976|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
595977|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
595978|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
595979|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
595980|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
595981|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
595982|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
595983|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
596067|NCT00974220|O1|Outcome|Placebo|nebulized 0.9% saline placebo
595984|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
595985|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
595986|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
595987|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
595988|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
595989|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
595990|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
595991|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
595992|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
595993|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
595994|NCT00981630|E4|Reported Event|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
595995|NCT00981630|E3|Reported Event|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
595996|NCT00981630|E2|Reported Event|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
595997|NCT00981630|E1|Reported Event|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
595998|NCT00981669|B3|Baseline|Total|Total of all reporting groups
595999|NCT00981669|B2|Baseline|Placebo|3 doses with 6 weeks interval
596000|NCT00981669|B1|Baseline|Rotavirus Vaccine|3 doses with 6 weeks interval
596001|NCT00981669|P2|Participant Flow|Placebo|3 doses with 6 weeks interval
596002|NCT00981669|P1|Participant Flow|Rotavirus Vaccine|3 doses with 6 weeks interval
596003|NCT00981669|O2|Outcome|Placebo|3 doses with 6 weeks interval
596004|NCT00981669|O1|Outcome|Rotavirus Vaccine|3 doses with 6 weeks interval
596005|NCT00981669|O2|Outcome|Placebo|3 doses with 6 weeks interval
596006|NCT00981669|O1|Outcome|Rotavirus Vaccine|3 doses with 6 weeks interval
596007|NCT00981669|E2|Reported Event|Placebo|3 doses with 6 weeks interval
596008|NCT00981669|E1|Reported Event|Rotavirus Vaccine|3 doses with 6 weeks interval
596009|NCT00981812|B1|Baseline|Primary|Women 25 years or older with a highly suspicious finding for possible breast cancer on mammography and/or ultrasound, who are to be scheduled for percutaneous breast biopsy.
596010|NCT00981812|P1|Participant Flow|PEM Breast Biopsy|PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software
596011|NCT00981812|O1|Outcome|Lesions Visualized Using Positron Emission Mammography (PEM)|Total lesions visualized using positron emission mammography.
596012|NCT00981812|E1|Reported Event|PEM Breast Biopsy|PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software
596013|NCT00981825|B3|Baseline|Total|Total of all reporting groups
596014|NCT00981825|B2|Baseline|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)
596015|NCT00981825|B1|Baseline|Fluoride 1st, Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)
596016|NCT00981825|P2|Participant Flow|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
596017|NCT00981825|P1|Participant Flow|Fluoride 1st , Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
596018|NCT00981825|O2|Outcome|Triclosan/Fluoride Toothpaste|Triclosan/Fluoride toothpaste (experimental)
596019|NCT00981825|O1|Outcome|Fluoride Toothpaste (Control)|Fluoride toothpaste (control)
596020|NCT00981825|E2|Reported Event|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
596021|NCT00981825|E1|Reported Event|Fluoride 1st , Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
596022|NCT00974051|B1|Baseline|All Study Subjects|Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
596023|NCT00974051|P3|Participant Flow|20% Basal Reduction First, Then Control, Then Terbutaline|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
596024|NCT00974051|P2|Participant Flow|Terbutaline First, Then 20% Basal Reduction, Then Control|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
596025|NCT00974051|P1|Participant Flow|Control First, Then Terbutaline, Then 20% Basal Reduction|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
596026|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
596027|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
596068|NCT00974220|E2|Reported Event|Fentanyl|nebulized fentanyl citrate (50 mcg)
596029|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
596030|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
596031|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
596032|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
596033|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
596034|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
596035|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
596036|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
596037|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
596038|NCT00974051|E4|Reported Event|20% Basal Reduction Arm|During 20% basal reduction night
596039|NCT00974051|E3|Reported Event|Terbutaline Arm|During turbutaline intervention night
596040|NCT00974051|E2|Reported Event|Control Arm|during control intervention night
596041|NCT00974051|E1|Reported Event|All Study Subjects|Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
596042|NCT00974090|B3|Baseline|Total|Total of all reporting groups
596043|NCT00974090|B2|Baseline|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596044|NCT00974090|B1|Baseline|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596045|NCT00974090|P2|Participant Flow|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596046|NCT00974090|P1|Participant Flow|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596047|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596048|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596049|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596050|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596136|NCT00974376|B2|Baseline|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
596051|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596052|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596053|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596054|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
596055|NCT00974090|E4|Reported Event|Teneli/Teneli + SU (Data Through Week 52)|"Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.
MedDRA 13.1"
596056|NCT00974090|E3|Reported Event|Placebo/Teneli + SU (Data From Week 12 to Week 52)|"Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.
MedDRA 13.1"
596057|NCT00974090|E2|Reported Event|Teneli/Teneli + SU (Data Through Week 12)|"Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.
MedDRA 13.0"
596058|NCT00974090|E1|Reported Event|Placebo/Teneli + SU (Data Through Week 12)|"Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.
MedDRA 13.0"
596059|NCT00974220|B3|Baseline|Total|Total of all reporting groups
596060|NCT00974220|B2|Baseline|Fentanyl - Placebo (Order)|nebulized fentanyl citrate in period 1, nebulized saline placebo in period 2.
596061|NCT00974220|B1|Baseline|Placebo - Fentanyl (Order)|nebulized saline placebo in period 1, nebulized fentanyl citrate in period 2.
596062|NCT00974220|P2|Participant Flow|Fentanyl - Placebo (Order)|nebulized fentanyl citrate (50 mcg) in period 1, nebulized 0.9% saline placebo in period 2
596063|NCT00974220|P1|Participant Flow|Placebo - Fentanyl (Order)|nebulized 0.9% saline placebo in period 1, nebulized fentanyl citrate 50mcg in period 2
596064|NCT00974220|O2|Outcome|Fentanyl|nebulized fentanyl citrate (50 mcg)
596065|NCT00974220|O1|Outcome|Placebo|nebulized 0.9% saline placebo
596066|NCT00974220|O2|Outcome|Fentanyl|nebulized fentanyl citrate (50 mcg)
596070|NCT00974233|B1|Baseline|Overall Study Population|Patient population with chronic lymphocytic leukemia/small lymphocytic lymphoma with progressive disease in need of therapy after at least 1 prior chemotherapy regimen, but no more than 5 prior unique chemotherapy regimens (retreatment with identical regimen did not count as a unique regimen).
596071|NCT00974233|P1|Participant Flow|Induction Chemoimmunotherapy + Maintenance Lenalidomide|Induction therapy: Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles. Maintenance therapy: Lenalidomide 5-10 mg orally continuously of each 28-day cycles for total of 12 treatment cycles.
596072|NCT00974233|O1|Outcome|Overall Study Population|Patient population with chronic lymphocytic leukemia/small lymphocytic lymphoma with progressive disease in need of therapy after at least 1 prior chemotherapy regimen, but no more than 5 prior unique chemotherapy regimens (retreatment with identical regimen did not count as a unique regimen).
596073|NCT00974233|O2|Outcome|Maintenance|Lenalidomide 5-10 mg administered orally daily as continuous therapy for up to 12 treatment cycles (28-day treatment cycles) in patients without disease progression or treatment-related toxicities that would prohibit ongoing treatment.
596074|NCT00974233|O1|Outcome|Induction Chemoimmunotherapy|Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles.
596075|NCT00974233|O4|Outcome|Overall Response Rate|Includes complete and partial responses.
596076|NCT00974233|O3|Outcome|Stable Disease|Stable disease includes cases where there has been objective improvement in blood counts and lymph node size, but does not meet criteria for either a complete or partial response.
596077|NCT00974233|O2|Outcome|Partial Response (PR)|Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count.
596078|NCT00974233|O1|Outcome|Complete Response (CR)|Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow.
596079|NCT00974233|O1|Outcome|Induction/Maintenance Chemotherapy|"Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Bendamustine: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
Rituximab: 375 mg/m2 Day 1 every 28 days for 6 cycles
Lenalidomide: 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol."
596080|NCT00974233|O1|Outcome|Induction/Maintenance Chemotherapy|"Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Bendamustine: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
Rituximab: 375 mg/m2 Day 1 every 28 days for 6 cycles
Lenalidomide: 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol."
596081|NCT00974233|E2|Reported Event|Maintenance|Lenalidomide 5-10 mg administered orally daily as continuous therapy for up to 12 treatment cycles (28-day treatment cycles) in patients without disease progression or treatment-related toxicities that would prohibit ongoing treatment.
596082|NCT00974233|E1|Reported Event|Induction Chemoimmunotherapy|Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles.
596083|NCT00974246|B1|Baseline|Baseline Characteristics|Nursing Home residents with either a confirmed diagnosis of COPD or an FEV1/FVC ratio <0.7 or in treatment with anticholinergic drugs.
596084|NCT00974246|P1|Participant Flow|Study Population:|The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio <0.7 or (3) in treatment with anticholinergic drugs.
596085|NCT00974246|O1|Outcome|Study Population:|The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio <0.7 or (3) in treatment with anticholinergic drugs.
596086|NCT00974246|O1|Outcome|Nursing Home Residents With COPD|The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
596087|NCT00974246|O1|Outcome|Nursing Home Residents With COPD|The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
596088|NCT00974246|E1|Reported Event|Adverse Events|All enrolled subjects.
596089|NCT00974311|B3|Baseline|Total|Total of all reporting groups
596090|NCT00974311|B2|Baseline|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596091|NCT00974311|B1|Baseline|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596092|NCT00974311|P2|Participant Flow|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596093|NCT00974311|P1|Participant Flow|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596094|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596095|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596096|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596097|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596098|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596099|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596100|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596101|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596102|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596103|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596104|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596105|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596106|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596107|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596108|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596109|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596110|NCT00974311|E2|Reported Event|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596111|NCT00974311|E1|Reported Event|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
596112|NCT00974363|B3|Baseline|Total|Total of all reporting groups
596137|NCT00974376|B1|Baseline|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
599806|NCT00994760|O1|Outcome|Initial Visit|
596113|NCT00974363|B2|Baseline|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596114|NCT00974363|B1|Baseline|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596115|NCT00974363|P2|Participant Flow|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596116|NCT00974363|P1|Participant Flow|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596117|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596118|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596119|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596120|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596121|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596122|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596123|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596124|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596125|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596126|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596127|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596128|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596129|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596130|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596131|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596132|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596133|NCT00974363|E2|Reported Event|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596134|NCT00974363|E1|Reported Event|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
596135|NCT00974376|B3|Baseline|Total|Total of all reporting groups
597536|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
596138|NCT00974376|P2|Participant Flow|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
596139|NCT00974376|P1|Participant Flow|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
596140|NCT00974376|O2|Outcome|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
596141|NCT00974376|O1|Outcome|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
596142|NCT00974376|E2|Reported Event|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
596143|NCT00974376|E1|Reported Event|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
596144|NCT00974480|B4|Baseline|Total|Total of all reporting groups
596145|NCT00974480|B3|Baseline|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596146|NCT00974480|B2|Baseline|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596147|NCT00974480|B1|Baseline|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596148|NCT00974480|P3|Participant Flow|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596149|NCT00974480|P2|Participant Flow|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596150|NCT00974480|P1|Participant Flow|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596151|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596152|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596153|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596154|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596155|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596156|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596157|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596158|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596159|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596160|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596161|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596162|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596163|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596164|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596165|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596166|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596167|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596168|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596169|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596195|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
596196|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596170|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596171|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596172|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596173|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596174|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596175|NCT00974480|O6|Outcome|Combination of Redermic and Rejuva-A - Assessor 2|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596176|NCT00974480|O5|Outcome|Rejuva-A - Assessor 2|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596177|NCT00974480|O4|Outcome|Redermic - Assessor 2|Cream applied twice a day every day, morning and evening for 24 weeks.
596178|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A - Assessor 1|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596179|NCT00974480|O2|Outcome|Rejuva-A - Assessor 1|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596180|NCT00974480|O1|Outcome|Redermic - Assessor 1|Cream applied twice a day every day, morning and evening for 24 weeks.
596220|NCT00974675|P1|Participant Flow|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596221|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
599807|NCT00994760|O2|Outcome|Last Visit|
596181|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596182|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596183|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596184|NCT00974480|E3|Reported Event|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
596185|NCT00974480|E2|Reported Event|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
596186|NCT00974480|E1|Reported Event|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
596187|NCT00974571|B4|Baseline|Total|Total of all reporting groups
596188|NCT00974571|B3|Baseline|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596189|NCT00974571|B2|Baseline|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
596190|NCT00974571|B1|Baseline|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596191|NCT00974571|P3|Participant Flow|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596192|NCT00974571|P2|Participant Flow|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
596193|NCT00974571|P1|Participant Flow|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596194|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596197|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596198|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
596199|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596200|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596201|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
596202|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596203|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596204|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
596205|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596206|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596207|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
596208|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596209|NCT00974571|E3|Reported Event|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596210|NCT00974571|E2|Reported Event|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
596211|NCT00974571|E1|Reported Event|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
596212|NCT00974675|B5|Baseline|Total|Total of all reporting groups
596213|NCT00974675|B4|Baseline|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
596214|NCT00974675|B3|Baseline|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596215|NCT00974675|B2|Baseline|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596216|NCT00974675|B1|Baseline|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596217|NCT00974675|P4|Participant Flow|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
596218|NCT00974675|P3|Participant Flow|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596219|NCT00974675|P2|Participant Flow|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596222|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596223|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596224|NCT00974675|O4|Outcome|Placebp|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
596225|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596226|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596227|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596228|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596229|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596230|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596231|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596232|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596233|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596234|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596235|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596236|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596237|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596238|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596239|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596240|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596241|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596627|NCT00983489|O3|Outcome|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
596242|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596243|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596244|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596245|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596246|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596247|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596248|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596249|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596250|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596251|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596252|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596253|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596254|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596255|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596256|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596257|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596258|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596259|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596260|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596261|NCT00974675|E4|Reported Event|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
596262|NCT00974675|E3|Reported Event|10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596263|NCT00974675|E2|Reported Event|5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596264|NCT00974675|E1|Reported Event|1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
596265|NCT00982007|B5|Baseline|Total|Total of all reporting groups
596266|NCT00982007|B4|Baseline|Cohort 2 (Group D) - IV Iron (Standard of Care)|Other IV iron IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion
596267|NCT00982007|B3|Baseline|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
599808|NCT00994760|O1|Outcome|Initial Visit|
596268|NCT00982007|B2|Baseline|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron
Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
596269|NCT00982007|B1|Baseline|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
596270|NCT00982007|P4|Participant Flow|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron
IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
596271|NCT00982007|P3|Participant Flow|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
596272|NCT00982007|P2|Participant Flow|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron
Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
596273|NCT00982007|P1|Participant Flow|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
596274|NCT00982007|O4|Outcome|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron
IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
596275|NCT00982007|O3|Outcome|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
596276|NCT00982007|O2|Outcome|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron
Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
596277|NCT00982007|O1|Outcome|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
596278|NCT00982007|E4|Reported Event|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron
IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
596279|NCT00982007|E3|Reported Event|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
596280|NCT00982007|E2|Reported Event|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron
Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
596281|NCT00982007|E1|Reported Event|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron
Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
596282|NCT00982020|B3|Baseline|Total|Total of all reporting groups
596330|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596283|NCT00982020|B2|Baseline|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.
Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits"
596284|NCT00982020|B1|Baseline|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.
Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
596285|NCT00982020|P2|Participant Flow|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
596286|NCT00982020|P1|Participant Flow|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
596287|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
596288|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
596289|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
596290|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
596291|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
596292|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
596293|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
599809|NCT00994760|O2|Outcome|Last Visit|
596294|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
596295|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.
Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits."
596296|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.
Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
596297|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.
Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits"
596298|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.
Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
596299|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
596300|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
596301|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
596302|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
596624|NCT00983489|P3|Participant Flow|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
596303|NCT00982020|E2|Reported Event|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks
Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits."
596304|NCT00982020|E1|Reported Event|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks
Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
596305|NCT00982033|B3|Baseline|Total|Total of all reporting groups
596306|NCT00982033|B2|Baseline|Placebo|"50% of subjects participating in this trial will be randomized to placebo.
placebo: placebo qd for 24 weeks."
596307|NCT00982033|B1|Baseline|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.
aliskiren: aliskiren 300mg qd for 24 weeks."
596308|NCT00982033|P2|Participant Flow|Placebo|"50% of subjects will be randomized to placebo.
placebo: placebo qd for 24 weeks"
596309|NCT00982033|P1|Participant Flow|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.
aliskiren: aliskiren 300mg qd versus placebo for 24 weeks."
596310|NCT00982033|O2|Outcome|Placebo|"50% of subjects participating in this trial will be randomized to placebo.
placebo: placebo qd for 24 weeks."
596311|NCT00982033|O1|Outcome|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.
aliskiren: aliskiren 300mg qd for 24 weeks."
596312|NCT00982033|E2|Reported Event|Placebo|"50% of subjects participating in this trial will be randomized to placebo.
placebo: placebo qd for 24 weeks."
596313|NCT00982033|E1|Reported Event|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.
aliskiren: aliskiren 300mg qd for 24 weeks."
596314|NCT00982111|B3|Baseline|Total|Total of all reporting groups
596315|NCT00982111|B2|Baseline|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596316|NCT00982111|B1|Baseline|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596317|NCT00982111|P2|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles."
596318|NCT00982111|P1|Participant Flow|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 milligrams (mg) (absolute dose) on Days 1 and 8 of every 3-week cycle.
Pemetrexed: 500 mg/square meter (mg/m2) intravenous (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles.
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles."
596319|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596480|NCT00983281|P1|Participant Flow|Hextend|Patients that received Hextend as part of their resuscitation fluid.
596320|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596321|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596322|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596323|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596324|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596325|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596326|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596327|NCT00982111|O1|Outcome|Necitumumab + Pemextrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596328|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596329|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596495|NCT00983294|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days.
596331|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596332|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596333|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596334|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596335|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596336|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596337|NCT00982111|E2|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596338|NCT00982111|E1|Reported Event|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
596339|NCT00982137|B5|Baseline|Total|Total of all reporting groups
596340|NCT00982137|B4|Baseline|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
596341|NCT00982137|B3|Baseline|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
596342|NCT00982137|B2|Baseline|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
596343|NCT00982137|B1|Baseline|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
596344|NCT00982137|P4|Participant Flow|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
596481|NCT00983281|O2|Outcome|Standard of Care|PAtients that did not receive Hextend as part of their resuscitation fluid.
596345|NCT00982137|P3|Participant Flow|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
596346|NCT00982137|P2|Participant Flow|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
596347|NCT00982137|P1|Participant Flow|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
596348|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
596349|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
596350|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
596351|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
596352|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
596353|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
596354|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-JE on Day 30.
596355|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
596356|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
596357|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
596358|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
596359|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
596556|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|Subgroup of participants with a score between 13 and 18.
596360|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
596361|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
596362|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
596363|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
596364|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
596365|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
596366|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.
596367|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
596368|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL|Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
596369|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
596370|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.
596371|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
596372|NCT00982137|E4|Reported Event|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
596373|NCT00982137|E3|Reported Event|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
596374|NCT00982137|E2|Reported Event|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
596375|NCT00982137|E1|Reported Event|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
596376|NCT00982189|B5|Baseline|Total|Total of all reporting groups
596482|NCT00983281|O1|Outcome|Hextend|Patients that received Hextend as part of their resuscitation fluid.
596377|NCT00982189|B4|Baseline|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
596378|NCT00982189|B3|Baseline|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
596379|NCT00982189|B2|Baseline|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
596380|NCT00982189|B1|Baseline|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
596381|NCT00982189|P4|Participant Flow|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
596382|NCT00982189|P3|Participant Flow|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
596383|NCT00982189|P2|Participant Flow|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
596384|NCT00982189|P1|Participant Flow|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
596385|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
596386|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
596387|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
596388|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
596389|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
596390|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
596391|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
596392|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
596393|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
596394|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
596395|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
596396|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
596397|NCT00982189|E4|Reported Event|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
596398|NCT00982189|E3|Reported Event|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
596399|NCT00982189|E2|Reported Event|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
596400|NCT00982189|E1|Reported Event|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
596401|NCT00982228|B3|Baseline|Total|Total of all reporting groups
596402|NCT00982228|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596403|NCT00982228|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596404|NCT00982228|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596405|NCT00982228|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596406|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596407|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596408|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596409|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596410|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596411|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596412|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596413|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596414|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596483|NCT00983281|E2|Reported Event|Standard of Care|Patients that received standard resuscitation but no Hextend as part of their resuscitation.
596415|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596416|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596417|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596418|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596419|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596420|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596421|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596422|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596423|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596424|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596425|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596426|NCT00982228|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
596427|NCT00982228|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
596428|NCT00982995|B1|Baseline|Palonosetron|"Palonosetron 0.25 mg I.V. bolus
Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
596429|NCT00982995|P1|Participant Flow|Palonosetron|"Palonosetron 0.25 mg I.V. bolus
Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
596430|NCT00982995|O1|Outcome|Palonosetron|"Palonosetron 0.25 mg I.V. bolus
Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
596431|NCT00982995|O1|Outcome|Palonosetron|"Palonosetron 0.25 mg I.V. bolus
Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
596432|NCT00982995|E1|Reported Event|Palonosetron|"Palonosetron 0.25 mg I.V. bolus
Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
596475|NCT00983242|E1|Reported Event|Colchicine Alone|At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
596476|NCT00983281|B3|Baseline|Total|Total of all reporting groups
596433|NCT00983073|B1|Baseline|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596434|NCT00983073|P1|Participant Flow|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596435|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596436|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596437|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596438|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596557|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|Subgroup of participants with a score between 0 and 12.
596439|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with either 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596440|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596441|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596442|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596477|NCT00983281|B2|Baseline|Standard of Care|Patients that received standard of care but no Hextend as part of their resuscitation.
596478|NCT00983281|B1|Baseline|Hextend|Patients that received Hextend as part of their resuscitation fluid.
596479|NCT00983281|P2|Participant Flow|Standard of Care|Patients that received standard of care but no Hextend as part of their resuscitation.
599810|NCT00994760|O1|Outcome|Initial Visit|
596443|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596444|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596445|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596446|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596447|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596448|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596449|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596450|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596451|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596452|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596453|NCT00983073|E1|Reported Event|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596454|NCT00983216|B1|Baseline|Colchicine Alone / With Ketoconazole (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Day 15, subjects began taking one 200 mg ketoconazole tablet twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one ketoconazole 200 mg tablet at 7:15 a.m. after an overnight fast. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
596455|NCT00983216|P1|Participant Flow|Colchicine Alone / With Ketoconazole (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Day 15, subjects began taking one 200 mg ketoconazole tablet twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one ketoconazole 200 mg tablet at 7:15 a.m. after an overnight fast. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
596456|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
596457|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596458|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
596459|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596460|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
596461|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596462|NCT00983216|E3|Reported Event|Colchicine With Ketoconazole (at Steady-state)|On the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
596463|NCT00983216|E2|Reported Event|Ketoconazole Alone|On Day 15 to 18, subjects took ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals.
596464|NCT00983216|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596465|NCT00983242|B1|Baseline|Colchicine Alone, Colchicine With Verapamil HCl ER|All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
596494|NCT00983294|E2|Reported Event|Azithromycin Alone|On Day 15, each subject received two 250mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250mg azithromycin tablet daily at 07:30 without regard to meals on Days 16 to 18.
596714|NCT00983853|O1|Outcome|EFV-based (Test, N=15) vs No HAART (Reference, N=7)|
596466|NCT00983242|P1|Participant Flow|Colchicine Alone, Colchicine With Verapamil HCl ER|All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
596467|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
596468|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
596469|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
596470|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
596471|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
596472|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
596473|NCT00983242|E3|Reported Event|Colchicine With Verapamil HCl ER|At 8am on Day 19 following a 10 hour fast all subjects received one dose of verapamil HCl ER 240 mg along with one dose of colchicine 0.6 mg.
596474|NCT00983242|E2|Reported Event|Verapamil HCl ER|At 8am on Days 15-18 all subjects received a dose of verapamil HCl ER 240 mg without regard to meals.
599811|NCT00994760|O2|Outcome|Last Visit|
596484|NCT00983281|E1|Reported Event|Hextend|Patients that received Hextend as part of their resuscitation fluid.
596485|NCT00983294|B1|Baseline|Colchicine Alone / With Azithromycin (at Steady State)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
596486|NCT00983294|P1|Participant Flow|Colchicine Alone / With Azithromycin (at Steady State)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30 am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250mg azithromycin tablet at 7:30 am after an overnight fast.
596487|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
596488|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
596489|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
596490|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
596491|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
596492|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
596493|NCT00983294|E3|Reported Event|Colchicine With Steady-state Azithromycin|On Day 19, each subject received both one 0.6mg colchicine tablet and one 250mg azithromycin tablet at 07:30 after an overnight fast.
597445|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
596496|NCT00983346|B1|Baseline|Arm -1 Bortezomib|"All participants enrolled.
Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m^2 on days 1, 8, 15, and 22 of each 42 day cycle.
Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
596497|NCT00983346|P1|Participant Flow|Arm -1 Bortezomib|"All participants enrolled.
Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m^2 on days 1, 8, 15, and 22 of each 42 day cycle.
Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
596498|NCT00983346|O1|Outcome|Arm 1 Bortezomib|"All participants enrolled.
Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.
Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
596499|NCT00983346|E1|Reported Event|Arm 1 Bortezomib|"All participants enrolled.
Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.
Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
596500|NCT00983359|B1|Baseline|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation
Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
596501|NCT00983359|P1|Participant Flow|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation
Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
596502|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation
Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
596503|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation
Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
596504|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation
Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
596505|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation
Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
596506|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation
Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
596507|NCT00983359|E1|Reported Event|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation
Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
596605|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
599812|NCT00994760|O1|Outcome|Initial Visit|
596508|NCT00983372|B1|Baseline|Colchicine Alone / With Diltiazem (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596509|NCT00983372|P1|Participant Flow|Colchicine Alone / With Diltiazem (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596510|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596511|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
596512|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596513|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
596514|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596515|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
596516|NCT00983372|E3|Reported Event|Colchicine With Steady-state Diltiazem|On Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596517|NCT00983372|E2|Reported Event|Diltiazem Alone|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m.
596518|NCT00983372|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
596586|NCT00983476|B1|Baseline|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI
in-person MOVE! SMI: Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
596587|NCT00983476|P3|Participant Flow|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
596519|NCT00983385|B1|Baseline|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596520|NCT00983385|P1|Participant Flow|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596521|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 12 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the maintenance period.
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
596522|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at end of Week 6 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
596523|NCT00983385|O1|Outcome|Tapentadol|Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.
596601|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596602|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
599813|NCT00994760|O2|Outcome|Last Visit|
596524|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 12 in PainDetect specific subgroup of participants that entered the maintenance period.
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
596525|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 6 in PainDetect specific subgroup of participants that entered the titration and optimal dose period.
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
596526|NCT00983385|O1|Outcome|Tapentadol|"Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants that entered the titration and optimal dose period.
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
596527|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596528|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596588|NCT00983476|P2|Participant Flow|Arm 2: Web-based MOVE! SMI|Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
596625|NCT00983489|P2|Participant Flow|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
596529|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596530|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596531|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596532|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596603|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596604|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596533|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596534|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596535|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596536|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596537|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596538|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596539|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596540|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596541|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596542|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596543|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596544|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596545|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596546|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596547|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596548|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596549|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.
596550|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
596551|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
596552|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.
596553|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
596554|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
596555|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|Subgroup of participants with a score between 19 and 38.
596558|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596559|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596560|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596561|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596562|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596563|NCT00983385|E1|Reported Event|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
596564|NCT00983437|B1|Baseline|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596565|NCT00983437|P1|Participant Flow|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596566|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596567|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596568|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596569|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596570|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596571|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596572|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596573|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596574|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596575|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596576|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596577|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596578|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596579|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596580|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596581|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596582|NCT00983437|E1|Reported Event|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
596583|NCT00983476|B4|Baseline|Total|Total of all reporting groups
596584|NCT00983476|B3|Baseline|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
596585|NCT00983476|B2|Baseline|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI
web-based MOVE! SMI: online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
596626|NCT00983489|P1|Participant Flow|Counselling|counselling: Breast feeding counselling will be done to mothers
596589|NCT00983476|P1|Participant Flow|Arm 1: In-person MOVE! SMI|In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
596590|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
596591|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI
web-based MOVE! SMI: online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
596592|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI
in-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
596593|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
596594|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI
web-based MOVE! SMI: online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
596595|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI
in-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
596596|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
596597|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596598|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596599|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
596600|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596606|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596607|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596608|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
596609|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596610|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596611|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
596612|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
596613|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
596614|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
596615|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596616|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
596617|NCT00983476|E3|Reported Event|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
596618|NCT00983476|E2|Reported Event|Arm 2: Web-based MOVE! SMI|Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
596619|NCT00983476|E1|Reported Event|Arm 1: In-person MOVE! SMI|In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
596620|NCT00983489|B4|Baseline|Total|Total of all reporting groups
596621|NCT00983489|B3|Baseline|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
596622|NCT00983489|B2|Baseline|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
596623|NCT00983489|B1|Baseline|Counselling|counselling: Breast feeding counselling will be done to mothers
596628|NCT00983489|O2|Outcome|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
596629|NCT00983489|O1|Outcome|Counselling|counselling: Breast feeding counselling will be done to mothers
596630|NCT00983489|E3|Reported Event|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
596631|NCT00983489|E2|Reported Event|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
596632|NCT00983489|E1|Reported Event|Counselling|counselling: Breast feeding counselling will be done to mothers
596633|NCT00983515|B1|Baseline|Colchicine Alone / With Ritonavir (at Steady-state)|[All subjects received each of the study treatments.] On Day 1, each subject received one colchicine 0.6 mg tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
596634|NCT00983515|P1|Participant Flow|Colchicine Alone / With Ritonavir (at Steady-state)|[All subjects received each of the study treatments.] On Day 1, each subject received one colchicine 0.6 mg tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
596635|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
596636|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
596637|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
596638|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
596639|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
596956|NCT00984256|O2|Outcome|Prophylaxis Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
596640|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
596641|NCT00983515|E3|Reported Event|Colchicine With Steady-state Ritonavir|On Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
596642|NCT00983515|E2|Reported Event|Ritonavir Alone|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals.
596643|NCT00983515|E1|Reported Event|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
596644|NCT00983541|B1|Baseline|All Patients|"All participants enrolled.
Brachytherapy or SBRT (Stereotactic body radiation therapy) : Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).
Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy
Gemcitabine"
596645|NCT00983541|P1|Participant Flow|All Patients|"All participants enrolled.
Brachytherapy or SBRT (Stereotactic body radiation therapy) : Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).
Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy
Gemcitabine"
596646|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.
Brachytherapy or SBRT (Stereotactic body radiation therapy) :
Fluorouracil (5-FU) :
Gemcitabine"
596647|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.
Brachytherapy or SBRT (Stereotactic body radiation therapy) :
Fluorouracil (5-FU) :
Gemcitabine"
596648|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.
Brachytherapy or SBRT (Stereotactic body radiation therapy) :
Fluorouracil (5-FU) :
Gemcitabine"
596649|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.
Brachytherapy or SBRT (Stereotactic body radiation therapy) :
Fluorouracil (5-FU) :
Gemcitabine"
596650|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.
Brachytherapy or SBRT (Stereotactic body radiation therapy) :
Fluorouracil (5-FU) :
Gemcitabine"
596651|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.
Brachytherapy or SBRT (Stereotactic body radiation therapy) :
Fluorouracil (5-FU) :
Gemcitabine"
596652|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.
Brachytherapy or SBRT (Stereotactic body radiation therapy) :
Fluorouracil (5-FU) :
Gemcitabine"
596653|NCT00983541|E1|Reported Event|All Patients|"All participants enrolled.
Brachytherapy or SBRT (Stereotactic body radiation therapy) :
Fluorouracil (5-FU) :
Gemcitabine"
596654|NCT00983645|B3|Baseline|Total|Total of all reporting groups
596688|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596655|NCT00983645|B2|Baseline|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
596656|NCT00983645|B1|Baseline|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
596657|NCT00983645|P2|Participant Flow|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
596658|NCT00983645|P1|Participant Flow|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
596659|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
596660|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
596661|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
596662|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
596663|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
596664|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
596665|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
596666|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
596667|NCT00983645|E2|Reported Event|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
596668|NCT00983645|E1|Reported Event|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
596669|NCT00983749|B3|Baseline|Total|Total of all reporting groups
596670|NCT00983749|B2|Baseline|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
596671|NCT00983749|B1|Baseline|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
596672|NCT00983749|P2|Participant Flow|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
596673|NCT00983749|P1|Participant Flow|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
596674|NCT00983749|O2|Outcome|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
596675|NCT00983749|O1|Outcome|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
596676|NCT00983749|O2|Outcome|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
596677|NCT00983749|O1|Outcome|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
596678|NCT00983749|E2|Reported Event|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
596679|NCT00983749|E1|Reported Event|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
596680|NCT00983801|B1|Baseline|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596681|NCT00983801|P1|Participant Flow|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596682|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596683|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596684|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596685|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596686|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596687|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596689|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596690|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596691|NCT00983801|E1|Reported Event|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
596692|NCT00983827|B1|Baseline|Aquatic Treadmill Training|
596693|NCT00983827|P1|Participant Flow|Aquatic Treadmill Training|Aquatic treadmill training (ATT) is a pool-based treadmill training that combines the three concepts of unweighting the body, treadmill training, and the resistance effects of water into one modality.
596694|NCT00983827|O1|Outcome|Aquatic Treadmill Training|
596695|NCT00983827|E1|Reported Event|Aquatic Treadmill Training|
596696|NCT00983853|B7|Baseline|Total|Total of all reporting groups
596697|NCT00983853|B6|Baseline|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
596698|NCT00983853|B5|Baseline|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
596699|NCT00983853|B4|Baseline|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
596700|NCT00983853|B3|Baseline|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
596701|NCT00983853|B2|Baseline|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
596702|NCT00983853|B1|Baseline|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
596703|NCT00983853|P6|Participant Flow|Part B: ATV/R-based HAART + Pbo/PR|"Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine
Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks
Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks
Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks
Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
The dose of ribavirin used (fixed versus weight-based) was region dependent."
596704|NCT00983853|P5|Participant Flow|Part B: ATV/R-based HAART + T/PR|"Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine
Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks
Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks
Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks
Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
The dose of ribavirin used (fixed versus weight-based) was region dependent."
596705|NCT00983853|P4|Participant Flow|Part B: EFV-based HAART + Pbo/PR|"Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine
Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks
Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks
Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks
Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
The dose of ribavirin used (fixed versus weight-based) was region dependent."
596706|NCT00983853|P3|Participant Flow|Part B: EFV-based HAART + T/PR|"Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine
Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks
Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks
Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks
Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
The dose of ribavirin used (fixed versus weight-based) was region dependent."
596707|NCT00983853|P2|Participant Flow|Part A: Pbo/PR|"Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks
Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks
Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks
Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
The dose of ribavirin used (fixed versus weight-based) was region dependent."
596708|NCT00983853|P1|Participant Flow|Part A: T/PR|"Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks
Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks
Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks
Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
The dose of ribavirin used (fixed versus weight-based) was region dependent."
596709|NCT00983853|O2|Outcome|Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
596710|NCT00983853|O1|Outcome|T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
596711|NCT00983853|O2|Outcome|Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
596712|NCT00983853|O1|Outcome|T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
596715|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596716|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596717|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596718|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596719|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
596720|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
596721|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596722|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596723|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596724|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596725|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
596726|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
596990|NCT00984295|B4|Baseline|Total|Total of all reporting groups
596727|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596728|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596729|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596730|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
596731|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
596732|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
596733|NCT00983853|E2|Reported Event|Total PR|Pooled PR from Part A and Part B
596734|NCT00983853|E1|Reported Event|T/PR|Pooled T/PR from Part A and Part B
596735|NCT00983892|B3|Baseline|Total|Total of all reporting groups
596736|NCT00983892|B2|Baseline|CarePartners -|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
596737|NCT00983892|B1|Baseline|CarePartners +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.
Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
596738|NCT00983892|P2|Participant Flow|CarePartners -|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
596739|NCT00983892|P1|Participant Flow|CarePartners +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.
Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
596740|NCT00983892|O2|Outcome|Control|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
596772|NCT00983931|B1|Baseline|Colchicine Alone / With Cyclosporine|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596741|NCT00983892|O1|Outcome|CarePartners Intervention +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.
Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
596742|NCT00983892|E2|Reported Event|CarePartners-|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
596743|NCT00983892|E1|Reported Event|CarePartners+|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.
Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
596744|NCT00983905|B1|Baseline|Theophylline Alone / With Colchicine (at Steady State)|[All subjects received each of the study treatments.] Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45am after an overnight fast of at least 10 hours, followed by a washout period of 4 days. On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45am and 7:45pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
596745|NCT00983905|P1|Participant Flow|Theophylline Alone / With Colchicine (at Steady State)|[All subjects received each of the study treatments.] Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45am after an overnight fast of at least 10 hours, followed by a washout period of 4 days. On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45am and 7:45pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
596746|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
596747|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
596947|NCT00984256|P1|Participant Flow|Control|The six volunteers in control cohort were enrolled as infectivity controls and did not undergo randomization or receive any study drug.
596748|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
596749|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
596750|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
596751|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
596752|NCT00983905|E3|Reported Event|Theophylline With Steady-state Colchicine|On Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45 am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
596753|NCT00983905|E2|Reported Event|Colchicine Alone|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals.
596754|NCT00983905|E1|Reported Event|Theophylline Alone|Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
596755|NCT00983918|B5|Baseline|Total|Total of all reporting groups
596756|NCT00983918|B4|Baseline|Propofol|General Anesthesia with Propofol
596757|NCT00983918|B3|Baseline|Isoflurane|General Anesthesia with Isoflurane
596758|NCT00983918|B2|Baseline|Sevoflurane|General Anesthesia with Sevoflurane
596759|NCT00983918|B1|Baseline|Desflurane|General Anesthesia with Desflurane
596760|NCT00983918|P4|Participant Flow|Propofol|General Anesthesia with Propofol
596761|NCT00983918|P3|Participant Flow|Isoflurane|General Anesthesia with Isoflurane
596762|NCT00983918|P2|Participant Flow|Sevoflurane|General Anesthesia with Sevoflurane
596763|NCT00983918|P1|Participant Flow|Desflurane|General Anesthesia with Desflurane
596764|NCT00983918|O4|Outcome|Propofol|General Anesthesia with Propofol
596765|NCT00983918|O3|Outcome|Isoflurane|General Anesthesia with Isoflurane
596766|NCT00983918|O2|Outcome|Sevoflurane|General Anesthesia with Sevoflurane
596767|NCT00983918|O1|Outcome|Desflurane|General Anesthesia with Desflurane
596768|NCT00983918|E4|Reported Event|Propofol|General Anesthesia with Propofol
596769|NCT00983918|E3|Reported Event|Isoflurane|General Anesthesia with Isoflurane
596770|NCT00983918|E2|Reported Event|Sevoflurane|General Anesthesia with Sevoflurane
596771|NCT00983918|E1|Reported Event|Desflurane|General Anesthesia with Desflurane
596935|NCT00984165|E2|Reported Event|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
596773|NCT00983931|P1|Participant Flow|Colchicine Alone / With Cyclosporine|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596774|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596775|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596776|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596777|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596778|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596779|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596780|NCT00983931|E2|Reported Event|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
596781|NCT00983931|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596782|NCT00983957|B1|Baseline|Ortho Tri-Cyclen + Daclatasvir|Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596783|NCT00983957|P1|Participant Flow|Ortho Tri-Cyclen + Daclatasvir|Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596948|NCT00984256|O5|Outcome|Treatment Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
596784|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596785|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596786|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596787|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596788|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596789|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596790|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596791|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596792|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596793|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596794|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596795|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596796|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596797|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596798|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596799|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596800|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596801|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596802|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596803|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
597060|NCT00984308|B3|Baseline|Total|Total of all reporting groups
597061|NCT00984308|B2|Baseline|Control|
596804|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596805|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596806|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596807|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596808|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596809|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
596810|NCT00983957|E6|Reported Event|Ortho Tri-Cyclen + Daclatasvir Days 68-77|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67 along with daclatasvir two tablets of 30-mg, orally, once daily from Day 68 to 77.
596811|NCT00983957|E5|Reported Event|Ortho Tri-Cyclen Days 57-67|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67.
596812|NCT00983957|E4|Reported Event|Ortho Tri-Cyclen Days 47-56|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 47 to 56.
596813|NCT00983957|E3|Reported Event|Ortho Tri-Cyclen Days 29-46|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 46.
596814|NCT00983957|E2|Reported Event|Ortho Tri-Cyclen Days 1-28|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28.
596815|NCT00983957|E1|Reported Event|All Treated Participants|Participants received sequentially Treatment A: Ortho Tri-Cyclen (OTC) fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 along with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
596816|NCT00983983|B4|Baseline|Total|Total of all reporting groups
596857|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
596817|NCT00983983|B3|Baseline|Control|"Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596818|NCT00983983|B2|Baseline|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596819|NCT00983983|B1|Baseline|High Fat/High Calorie|"High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596820|NCT00983983|P3|Participant Flow|Control|"Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596821|NCT00983983|P2|Participant Flow|High Calorie|"High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596822|NCT00983983|P1|Participant Flow|High Fat/High Calorie|"High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596823|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596824|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596825|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596826|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596827|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
597062|NCT00984308|B1|Baseline|Intervention|
596828|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596829|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596830|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596831|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596832|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596833|NCT00983983|O2|Outcome|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596858|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
596949|NCT00984256|O4|Outcome|Treatment Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
596834|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596835|NCT00983983|E3|Reported Event|Control|"Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596836|NCT00983983|E2|Reported Event|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596837|NCT00983983|E1|Reported Event|High Fat/High Calorie|"High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
596838|NCT00984009|B1|Baseline|Colchicine Alone / With Grapefruit Juice|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
596839|NCT00984009|P1|Participant Flow|Colchicine Alone / With Grapefruit Juice|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
596840|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
596841|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596842|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
596843|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596844|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
596845|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596846|NCT00984009|E3|Reported Event|Colchicine With Grapefruit Juice|On Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
596847|NCT00984009|E2|Reported Event|Grapefruit Juice Alone|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals.
596848|NCT00984009|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
596849|NCT00984022|B3|Baseline|Total|Total of all reporting groups
596850|NCT00984022|B2|Baseline|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
596851|NCT00984022|B1|Baseline|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
596852|NCT00984022|P2|Participant Flow|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
596853|NCT00984022|P1|Participant Flow|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
596854|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
596855|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
596856|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
596950|NCT00984256|O3|Outcome|Treatment Group 3|(Group 3) Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
596859|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
596860|NCT00984022|E2|Reported Event|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
596861|NCT00984022|E1|Reported Event|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
596862|NCT00984061|B1|Baseline|Colchicine Alone / With Clarithromycin|[All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
596863|NCT00984061|P1|Participant Flow|Colchicine Alone / With Clarithromycin|[All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
596864|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
596865|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
596866|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
596867|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
596868|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
596869|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
596870|NCT00984061|E3|Reported Event|Colchicine With Clarithromycin|On the morning of Day 29 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with the last dose of clarithromycin.
596871|NCT00984061|E2|Reported Event|Clarithromycin Alone|On the evening of Day 22, subjects began taking (on an outpatient basis) one tablet of clarithromycin 250 mg every 12 hours for 7 days without regard to meals.
596872|NCT00984061|E1|Reported Event|Colchicine Alone|On the morning of Day 1 after a fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg.
596873|NCT00984126|B5|Baseline|Total|Total of all reporting groups
596925|NCT00984165|P1|Participant Flow|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
596874|NCT00984126|B4|Baseline|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596875|NCT00984126|B3|Baseline|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596951|NCT00984256|O2|Outcome|Treatment Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
596952|NCT00984256|O1|Outcome|Treatment Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
596953|NCT00984256|O5|Outcome|Prophylaxis Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
596954|NCT00984256|O4|Outcome|Prophylaxis Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
596955|NCT00984256|O3|Outcome|Prophylaxis Group 3|(Group 3)Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
597537|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
596876|NCT00984126|B2|Baseline|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596877|NCT00984126|B1|Baseline|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during the trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in the relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in the relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016)
596878|NCT00984126|P4|Participant Flow|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596879|NCT00984126|P3|Participant Flow|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly.On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596880|NCT00984126|P2|Participant Flow|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596926|NCT00984165|O4|Outcome|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
596927|NCT00984165|O3|Outcome|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
596928|NCT00984165|O2|Outcome|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
616964|NCT01032759|O2|Outcome|Placebo|"Placebo
Placebo: BID"
596881|NCT00984126|P1|Participant Flow|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during the trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in the relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in the relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016)
596895|NCT00984126|O2|Outcome|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596882|NCT00984126|O7|Outcome|Adults (>=18 Years)-(On-Demand Regimen [Sub-trial])|Subjects (≥18 Years) in sub-trial received turoctocog alfa (on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). On-Demand regimen: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment.
596883|NCT00984126|O6|Outcome|Adults (>=18 Years)-(On-Demand Regimen [Main Trial])|Subjects (≥18 Years) in main trial received turoctocog alfa (on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). On-Demand regimen: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment.
596884|NCT00984126|O5|Outcome|Adolescents (12-<18 Years)-(On-Demand Regimen [Main Trial])|Subjects (12-<18 Years) in main trial received turoctocog alfa (on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009–30 Jun 2016). On-Demand regimen: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment.
596885|NCT00984126|O4|Outcome|Adults (>= 18 Years) - Preventive Regimen [Main Trial]|Subjects (>=18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: Turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
596886|NCT00984126|O3|Outcome|Adolescents (12 - <18 Years) - Preventive Regimen [Main Trial]|Subjects (12-<18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
596887|NCT00984126|O2|Outcome|Older Children (6 - <12 Years)-Preventive Regimen [Main Trial]|Subjects (6-<12 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
596929|NCT00984165|O1|Outcome|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
616965|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
596896|NCT00984126|O1|Outcome|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during the trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in the relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in the relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016)
596888|NCT00984126|O1|Outcome|Small Children (0 - <6 Years)-Preventive Regimen [Main Trial]|Subjects (0-<6 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or trial site was terminated by Novo Nordisk or relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009–30 Jun 2016). Preventive regimen: turoctocog alfa as slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly.
596889|NCT00984126|O4|Outcome|Adults (≥18 Years)-Preventive Regimen [Main Trial]|Subjects (>=18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: Turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
596890|NCT00984126|O3|Outcome|Adolescents (12 - <18 Years)-Preventive Regimen [Main Trial]|Subjects (12-<18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
596891|NCT00984126|O2|Outcome|Older Children (6 - <12 Years)-Preventive Regimen [Main Trial]|Subjects (6-<12 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
596892|NCT00984126|O1|Outcome|Small Children (0 - <6 Years)-Preventive Regimen [Main Trial]|Subjects (0-<6 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or trial site was terminated by Novo Nordisk or relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009–30 Jun 2016). Preventive regimen: turoctocog alfa as slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly.
596893|NCT00984126|O4|Outcome|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596894|NCT00984126|O3|Outcome|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596930|NCT00984165|O3|Outcome|Donor Lymphocyte Infusion-Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
596931|NCT00984165|O2|Outcome|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
596897|NCT00984126|O4|Outcome|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596898|NCT00984126|O3|Outcome|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596899|NCT00984126|O2|Outcome|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596900|NCT00984126|O1|Outcome|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during the trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in the relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in the relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016)
596901|NCT00984126|E4|Reported Event|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until the trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596932|NCT00984165|O1|Outcome|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
596933|NCT00984165|E4|Reported Event|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
596934|NCT00984165|E3|Reported Event|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
596902|NCT00984126|E3|Reported Event|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596903|NCT00984126|E2|Reported Event|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596904|NCT00984126|E1|Reported Event|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
596905|NCT00984139|B1|Baseline|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596906|NCT00984139|P1|Participant Flow|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596907|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596908|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596909|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596910|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596911|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596912|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596913|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596914|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596915|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596916|NCT00984139|E1|Reported Event|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
596917|NCT00984165|B5|Baseline|Total|Total of all reporting groups
596918|NCT00984165|B4|Baseline|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
596919|NCT00984165|B3|Baseline|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
596920|NCT00984165|B2|Baseline|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
596921|NCT00984165|B1|Baseline|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
596922|NCT00984165|P4|Participant Flow|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
596923|NCT00984165|P3|Participant Flow|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
596924|NCT00984165|P2|Participant Flow|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
596936|NCT00984165|E1|Reported Event|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
596937|NCT00984204|B1|Baseline|Treatment Arm|
596938|NCT00984204|P1|Participant Flow|Treatment Arm|
596939|NCT00984204|O1|Outcome|Treatment Arm|
596940|NCT00984204|O1|Outcome|Treatment Arm|
596941|NCT00984204|O1|Outcome|Treatment Arm|
596942|NCT00984204|E1|Reported Event|Treatment Arm|
596943|NCT00984256|B3|Baseline|Total|Total of all reporting groups
596944|NCT00984256|B2|Baseline|Control|The six (6) Control volunteers were enrolled in a open label arm and received no treatment prior to malaria challenge.
596945|NCT00984256|B1|Baseline|Malarone|"Thirty (30) subjects were placed in the Malarone (treatment) Arm. The thirty subjects were then randomized into 5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge. The groups received treatment as follows:
Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
596946|NCT00984256|P2|Participant Flow|Malarone Treatment|"Within the Malarone Arm, thirty volunteers were randomized into the below 5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge.
Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
597538|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
596957|NCT00984256|O1|Outcome|Prophylaxis Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
596958|NCT00984256|O6|Outcome|Control|Six volunteers for the control cohort were enrolled as an infectivity control and did not undergo drug dosing.
596959|NCT00984256|O5|Outcome|Treatment Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
596960|NCT00984256|O4|Outcome|Treatment Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
596961|NCT00984256|O3|Outcome|Treatment Group 3|(Group 3) Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
596962|NCT00984256|O2|Outcome|Treatment Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
596963|NCT00984256|O1|Outcome|Treatment Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
596964|NCT00984256|E2|Reported Event|Control|no malarone prophylaxis received
596965|NCT00984256|E1|Reported Event|Drug|"Partially randomized, double-blind, placebo-controlled trial using a human Plasmodium falciparum challenge to evaluate malaria chemoprophylaxis of Malarone in 36 healthy adults. Subjects were enrolled in 1 of 2 cohorts based on subject preference. Thirty subjects were placed in the prophylaxis cohort (Cohort 1) and 6 subjects were placed in the control cohort (Cohort 2)
5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge.
Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
596966|NCT00984282|B3|Baseline|Total|Total of all reporting groups
596967|NCT00984282|B2|Baseline|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle.
596968|NCT00984282|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
596969|NCT00984282|P2|Participant Flow|DB Placebo First, Then Option of OL Sorafenib Treatment|Double-blind period: participants received matching placebo tablets orally twice daily, 28 days comprised a cycle. Open-label (OL) period: participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle.
596970|NCT00984282|P1|Participant Flow|DB Sorafenib First, Then Option of OL Sorafenib Treatment|Double-blind period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Open-label (OL) period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
596971|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
596972|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
596973|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
596974|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
616966|NCT01032759|O2|Outcome|Placebo|"Placebo
Placebo: BID"
596975|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
596976|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
596977|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
596978|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
596979|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
596980|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
596981|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
596982|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
596983|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
596984|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
596985|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
596986|NCT00984282|E4|Reported Event|Placebo, Open Label Only (Switch to Sorafenib)|Reporting Group 3: Participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of open label period to the data cutoff on 31 Aug 20
596987|NCT00984282|E3|Reported Event|Sorafenib, Open Label Only (Sorafenib Continued)|Reporting Group 3: Participants on sorafenib who continued OL sorafenib treat., received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of OL period to the data cutoff on 31 Aug
596988|NCT00984282|E2|Reported Event|Placebo (Double Blind Only)|Reporting Group 2: Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double-blind period.
596989|NCT00984282|E1|Reported Event|Sorafenib (Double Blind Only)|Reporting Group 1: Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double blind period
596991|NCT00984295|B3|Baseline|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
596992|NCT00984295|B2|Baseline|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
596993|NCT00984295|B1|Baseline|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
596994|NCT00984295|P3|Participant Flow|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
596995|NCT00984295|P2|Participant Flow|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
596996|NCT00984295|P1|Participant Flow|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
596997|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
596998|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
596999|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597000|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
616967|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
597001|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597002|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597003|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597004|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597005|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597006|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597007|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597008|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597009|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597088|NCT00984334|O1|Outcome|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.
Placebo :"
597010|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597011|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597012|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597013|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597014|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597015|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597016|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597017|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597018|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597019|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597020|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597021|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597022|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597023|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597024|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597025|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597026|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597027|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597028|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597029|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597030|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597031|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597032|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597033|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597034|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597035|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597036|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597037|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597038|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597039|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597063|NCT00984308|P2|Participant Flow|Control|The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
597446|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
597040|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597041|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597042|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597043|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597044|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597045|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597046|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597047|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597048|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597049|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597050|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597051|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597052|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597053|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597054|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597055|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597056|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597057|NCT00984295|E3|Reported Event|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597058|NCT00984295|E2|Reported Event|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
597059|NCT00984295|E1|Reported Event|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
597064|NCT00984308|P1|Participant Flow|Intervention|The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
597065|NCT00984308|O2|Outcome|Control|
597066|NCT00984308|O1|Outcome|Intervention|
597067|NCT00984308|O2|Outcome|Control|
597068|NCT00984308|O1|Outcome|Intervention|
597069|NCT00984308|O2|Outcome|Control|
597070|NCT00984308|O1|Outcome|Intervention|
597071|NCT00984308|E2|Reported Event|Control|
597072|NCT00984308|E1|Reported Event|Intervention|
597073|NCT00984334|B6|Baseline|Total|Total of all reporting groups
597074|NCT00984334|B5|Baseline|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 5 mg capsules :"
597075|NCT00984334|B4|Baseline|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 20mg capsules :"
597076|NCT00984334|B3|Baseline|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 2.5 mg capsules :"
597077|NCT00984334|B2|Baseline|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 10 mg capsules :"
597078|NCT00984334|B1|Baseline|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.
Placebo :"
597079|NCT00984334|P5|Participant Flow|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 5 mg capsules :"
597080|NCT00984334|P4|Participant Flow|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 20mg capsules :"
597081|NCT00984334|P3|Participant Flow|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 2.5 mg capsules :"
597082|NCT00984334|P2|Participant Flow|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 10 mg capsules :"
597083|NCT00984334|P1|Participant Flow|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.
Placebo :"
597084|NCT00984334|O5|Outcome|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 5 mg capsules :"
597085|NCT00984334|O4|Outcome|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 20mg capsules :"
597086|NCT00984334|O3|Outcome|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 2.5 mg capsules :"
597087|NCT00984334|O2|Outcome|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 10 mg capsules :"
597089|NCT00984334|E5|Reported Event|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 5 mg capsules :"
597090|NCT00984334|E4|Reported Event|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 20mg capsules :"
597091|NCT00984334|E3|Reported Event|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 2.5 mg capsules :"
597092|NCT00984334|E2|Reported Event|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 10 mg capsules :"
597093|NCT00984334|E1|Reported Event|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.
Placebo :"
597094|NCT00984490|B1|Baseline|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
597095|NCT00984490|P1|Participant Flow|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
597096|NCT00984490|O1|Outcome|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery)
597097|NCT00984490|O1|Outcome|Metformin|Metformin: 850 mg orally (PO) twice a day for 7-21 days, discontinued 24-36 hrs prior to surgery
597098|NCT00984490|E1|Reported Event|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
597099|NCT00984542|B1|Baseline|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
597100|NCT00984542|P1|Participant Flow|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
597101|NCT00984542|O1|Outcome|Bendatmustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
597102|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
597103|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
597104|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
597105|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
597106|NCT00984542|E1|Reported Event|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
597107|NCT00984568|B3|Baseline|Total|Total of all reporting groups
597108|NCT00984568|B2|Baseline|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
597109|NCT00984568|B1|Baseline|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
597110|NCT00984568|P2|Participant Flow|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
597111|NCT00984568|P1|Participant Flow|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
597112|NCT00984568|O2|Outcome|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
597113|NCT00984568|O1|Outcome|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
597114|NCT00984568|O2|Outcome|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
597115|NCT00984568|O1|Outcome|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
597116|NCT00984568|E2|Reported Event|Step-Up|"Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2
g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter."
597117|NCT00984568|E1|Reported Event|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
597118|NCT00984594|B3|Baseline|Total|Total of all reporting groups
597119|NCT00984594|B2|Baseline|Primary|CR Plug will be placed in the site of the primary injury
597120|NCT00984594|B1|Baseline|Backfill|Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
597121|NCT00984594|P2|Participant Flow|Primary|CR Plug will be placed in the site of the primary injury.
597122|NCT00984594|P1|Participant Flow|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
597123|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
597124|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
597125|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
597126|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
597127|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
597128|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
597129|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
597130|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
597131|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury
597132|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
597133|NCT00984594|E2|Reported Event|Primary|Autograft will be placed in primary defect site.
597134|NCT00984594|E1|Reported Event|Backfill|CR-Plug will be placed in harvest site.
597135|NCT00984620|B3|Baseline|Total|Total of all reporting groups
597136|NCT00984620|B2|Baseline|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597137|NCT00984620|B1|Baseline|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597138|NCT00984620|P2|Participant Flow|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597139|NCT00984620|P1|Participant Flow|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597140|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597141|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597142|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597143|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597144|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597145|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597146|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597235|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
597236|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
597147|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597148|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597149|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597150|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597151|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597152|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597153|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597191|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597217|NCT00984815|B1|Baseline|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
597154|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597155|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597156|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597157|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597158|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597159|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597160|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597161|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597162|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597163|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597164|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597165|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597166|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597192|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597193|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597167|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597168|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597169|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597170|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597171|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
597172|NCT00984620|E2|Reported Event|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV).
597539|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
597173|NCT00984620|E1|Reported Event|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks.
597174|NCT00984659|B5|Baseline|Total|Total of all reporting groups
597175|NCT00984659|B4|Baseline|Albuterol and/or Ipratropium: Run-in Failure|Participants who entered the 2-week Run-in Period, during which they were permitted to use albuterol and/or ipratropium as rescue medication, but then failed to be randomized, or were randomized but did not receive a dose of study medication
597176|NCT00984659|B3|Baseline|FSC 250/50 mcg|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID
597177|NCT00984659|B2|Baseline|SAL 50 mcg|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID
597178|NCT00984659|B1|Baseline|Placebo|Matching placebo via DISKUS, administered as one inhalation twice daily (BID)
597179|NCT00984659|P4|Participant Flow|FSC 250/50 mcg: Double-blind Treatment Period|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
597180|NCT00984659|P3|Participant Flow|SAL 50 mcg: Double-blind Treatment Period|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
597181|NCT00984659|P2|Participant Flow|Placebo: Double-blind Treatment Period|Matching placebo via DISKUS, administered as one inhalation twice daily (BID) during the 6-week Double-blind Treatment Period
597182|NCT00984659|P1|Participant Flow|Albuterol and/or Ipratropium: Run-in Period|Participants were permitted to use albuterol and/or ipratropium as rescue medication during the 2-week Run-in Period
597183|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597184|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597185|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597186|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597187|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597188|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597189|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597190|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597447|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
616968|NCT01032759|O2|Outcome|Placebo|"Placebo
Placebo: BID"
597194|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
597195|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
597196|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
597197|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
597198|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
597199|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
597200|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
597201|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
597202|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
597203|NCT00984659|E3|Reported Event|FSC 250/50 mcg|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
597204|NCT00984659|E2|Reported Event|SAL 50 mcg|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID
597205|NCT00984659|E1|Reported Event|Placebo|Matching placebo via DISKUS, administered as one inhalation twice daily (BID)
597206|NCT00984698|B3|Baseline|Total|Total of all reporting groups
597237|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
597238|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
599814|NCT00994760|O1|Outcome|Initial Visit|
597207|NCT00984698|B2|Baseline|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
597208|NCT00984698|B1|Baseline|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
597209|NCT00984698|P2|Participant Flow|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
597210|NCT00984698|P1|Participant Flow|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
597211|NCT00984698|O2|Outcome|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
597212|NCT00984698|O1|Outcome|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
597213|NCT00984698|O2|Outcome|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
597214|NCT00984698|O1|Outcome|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
597215|NCT00984698|E2|Reported Event|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
597216|NCT00984698|E1|Reported Event|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
597218|NCT00984815|P1|Participant Flow|HZT-501|Open-label treatment with HZT-501(ibuprofen 800 mg/famotidine 26.6 mg) tablets. All doses of study drug will be self-administered orally 3 times daily (TID), for up to 54 weeks.
597219|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
597220|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
597221|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
597222|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
597223|NCT00984815|E1|Reported Event|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
597224|NCT00984867|B3|Baseline|Total|Total of all reporting groups
597225|NCT00984867|B2|Baseline|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
597226|NCT00984867|B1|Baseline|Placebo|Placebo plus sitagliptin alone or in combination with metformin
597227|NCT00984867|P2|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
597228|NCT00984867|P1|Participant Flow|Placebo|Placebo plus sitagliptin alone or in combination with metformin
597229|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
597230|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
597231|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
597232|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
597233|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
597234|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
597239|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
597240|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
597241|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
597242|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin
597243|NCT00984867|E2|Reported Event|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Safety analysis set.
597244|NCT00984867|E1|Reported Event|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Safety analysis set.
597245|NCT00985010|B3|Baseline|Total|Total of all reporting groups
597246|NCT00985010|B2|Baseline|Males|Brain death
597247|NCT00985010|B1|Baseline|Females|Brain death
597248|NCT00985010|P2|Participant Flow|Males|Brain death
597249|NCT00985010|P1|Participant Flow|Females|Brain death
597250|NCT00985010|O2|Outcome|Males|Brain death
597251|NCT00985010|O1|Outcome|Females|Brain death
597252|NCT00985010|O2|Outcome|Males|Brain death
597253|NCT00985010|O1|Outcome|Females|Brain death
597254|NCT00985010|E2|Reported Event|Males|Brain death
597255|NCT00985010|E1|Reported Event|Females|Brain death
597256|NCT00985114|B3|Baseline|Total|Total of all reporting groups
597257|NCT00985114|B2|Baseline|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling
Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
597258|NCT00985114|B1|Baseline|Device|"EndoBarrier
EndoBarrier: EndoBarrier implant"
597259|NCT00985114|P2|Participant Flow|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling
Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
597260|NCT00985114|P1|Participant Flow|EndoBarrier Device|"EndoBarrier
EndoBarrier: EndoBarrier implant"
597261|NCT00985114|O2|Outcome|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling
Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
597262|NCT00985114|O1|Outcome|Device|"EndoBarrier
EndoBarrier: EndoBarrier implant"
597263|NCT00985114|E2|Reported Event|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling
Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
597264|NCT00985114|E1|Reported Event|Device and Cross Over|"EndoBarrier
EndoBarrier: EndoBarrier implant"
597265|NCT00985140|B1|Baseline|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy.
597266|NCT00985140|P1|Participant Flow|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy. .
597300|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
597267|NCT00985140|O1|Outcome|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy. .
597268|NCT00985140|E1|Reported Event|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy. .
597269|NCT00985153|B5|Baseline|Total|Total of all reporting groups
597270|NCT00985153|B4|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597271|NCT00985153|B3|Baseline|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597272|NCT00985153|B2|Baseline|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
597273|NCT00985153|B1|Baseline|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597274|NCT00985153|P4|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597275|NCT00985153|P3|Participant Flow|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597276|NCT00985153|P2|Participant Flow|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
597277|NCT00985153|P1|Participant Flow|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597278|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597279|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597280|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
599815|NCT00994760|O2|Outcome|Last Visit|
597281|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597282|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597283|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597284|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
597285|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597286|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597287|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597288|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
597289|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597290|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597291|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597292|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
597293|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597294|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597295|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597296|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
597297|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597298|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597299|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597448|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
597301|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597302|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597303|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597304|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
597305|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597306|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597307|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597308|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
597309|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597310|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597311|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597312|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
597313|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597314|NCT00985153|E4|Reported Event|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
597315|NCT00985153|E3|Reported Event|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
597540|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
597316|NCT00985153|E2|Reported Event|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
597317|NCT00985153|E1|Reported Event|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
597318|NCT00985166|B4|Baseline|Total|Total of all reporting groups
597319|NCT00985166|B3|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
597320|NCT00985166|B2|Baseline|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
597321|NCT00985166|B1|Baseline|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
597322|NCT00985166|P3|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
597323|NCT00985166|P2|Participant Flow|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
597324|NCT00985166|P1|Participant Flow|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
597325|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
597326|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
597327|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
597328|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1
597329|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
597330|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
597331|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
597332|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
597333|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
597334|NCT00985166|O2|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
597335|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
597336|NCT00985166|E3|Reported Event|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
597337|NCT00985166|E2|Reported Event|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
597338|NCT00985166|E1|Reported Event|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
597339|NCT00985192|B1|Baseline|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
everolimus
laboratory biomarker analysis"
597340|NCT00985192|P1|Participant Flow|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
everolimus
laboratory biomarker analysis"
597341|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
everolimus
laboratory biomarker analysis"
597342|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
everolimus
laboratory biomarker analysis"
597343|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
everolimus
laboratory biomarker analysis"
597344|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
everolimus
laboratory biomarker analysis"
597345|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
everolimus
laboratory biomarker analysis"
597346|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
everolimus
laboratory biomarker analysis"
597347|NCT00985192|E1|Reported Event|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
everolimus
laboratory biomarker analysis"
597348|NCT00985231|B3|Baseline|Total|Total of all reporting groups
597349|NCT00985231|B2|Baseline|SofLens59 Contact Lens|
597350|NCT00985231|B1|Baseline|PureVision Multi-Focal Contact Lenses|
597351|NCT00985231|P2|Participant Flow|SofLens59 Contact Lens|
597352|NCT00985231|P1|Participant Flow|PureVision Multi-Focal Contact Lenses|
597353|NCT00985231|O2|Outcome|SofLens59 Contact Lens|
597354|NCT00985231|O1|Outcome|PureVision Multi-Focal Contact Lenses|
597355|NCT00985231|O2|Outcome|SofLens59 Contact Lens|
597356|NCT00985231|O1|Outcome|PureVision Multi-Focal Contact Lenses|
597357|NCT00985231|E2|Reported Event|SofLens59 Contact Lens|
597358|NCT00985231|E1|Reported Event|PureVision Multi-Focal Contact Lenses|
597359|NCT00985257|B1|Baseline|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
597360|NCT00985257|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
597361|NCT00985257|O1|Outcome|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
597362|NCT00985257|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
597363|NCT00977704|B1|Baseline|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
597364|NCT00977704|P1|Participant Flow|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
597365|NCT00977704|O1|Outcome|Restylane and Perlane|Single arm safety study of subjects receiving Restylane and Perlane.
597366|NCT00977704|E1|Reported Event|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
597367|NCT00977769|B4|Baseline|Total|Total of all reporting groups
597368|NCT00977769|B3|Baseline|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
597369|NCT00977769|B2|Baseline|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
597370|NCT00977769|B1|Baseline|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
597371|NCT00977769|P3|Participant Flow|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
597372|NCT00977769|P2|Participant Flow|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
597373|NCT00977769|P1|Participant Flow|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
597374|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
597375|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
597376|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
597377|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
597378|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
597379|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
597380|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
597381|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
597382|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
597383|NCT00977769|E3|Reported Event|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
597384|NCT00977769|E2|Reported Event|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
597385|NCT00977769|E1|Reported Event|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
597412|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597413|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597414|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597415|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597386|NCT00977808|B1|Baseline|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects’ usual insulin routine and their personal insulin pump.
At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
597387|NCT00977808|P1|Participant Flow|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects’ usual insulin routine and their personal insulin pump.
At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
597388|NCT00977808|O2|Outcome|Control: Open-Loop|Insulin dosing was performed by the patient (using their normal routine and personal insulin pump) under a physician's supervision.
597389|NCT00977808|O1|Outcome|Experimental: Closed-Loop Model Predictive Control (MPC)|Insulin dosing was performed by a model-predictive control (MPC) algorithm.
597390|NCT00977808|E1|Reported Event|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects' usual insulin routine and their personal insulin pump.
At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
597391|NCT00977938|B5|Baseline|Total|Total of all reporting groups
599816|NCT00994760|O1|Outcome|Initial Visit|
597392|NCT00977938|B4|Baseline|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597393|NCT00977938|B3|Baseline|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597394|NCT00977938|B2|Baseline|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597395|NCT00977938|B1|Baseline|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597396|NCT00977938|P4|Participant Flow|BMS 12-month DAPT|Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
597397|NCT00977938|P3|Participant Flow|BMS 30-month DAPT|Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
597398|NCT00977938|P2|Participant Flow|DES 12-month DAPT|Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
597399|NCT00977938|P1|Participant Flow|DES 30-month DAPT|Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
597400|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597401|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597402|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597403|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597404|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597405|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597406|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597407|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597408|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597409|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597410|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597411|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597444|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
597416|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597417|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597418|NCT00977938|O2|Outcome|Propensity-matched BMS|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 2,056 BMS-treated patients were eligible for propensity matching, of whom 1,718 were matched to at least one DES-treated patient (a BMS patient could be matched to up to 8 DES patients; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
597419|NCT00977938|O1|Outcome|Propensity-matched DES|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 13,257 DES-treated patients were eligible for propensity matching, of whom 8,308 patients were matched to BMS-treated patients (up to 8 DES patients could be matched to a BMS patient; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
597420|NCT00977938|O2|Outcome|Propensity-matched BMS|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 2,056 BMS-treated patients were eligible for propensity matching, of whom 1,718 were matched to at least one DES-treated patient (a BMS patient could be matched to up to 8 DES patients; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
597466|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
599817|NCT00994760|O2|Outcome|Last Visit|
597421|NCT00977938|O1|Outcome|Propensity-matched DES|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 13,257 DES-treated patients were eligible for propensity matching, of whom 8,308 patients were matched to BMS-treated patients (up to 8 DES patients could be matched to a BMS patient; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
597422|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597423|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597424|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597425|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597426|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
597427|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
597428|NCT00977938|E4|Reported Event|HCRI DAPT - BMS 12-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT
597429|NCT00977938|E3|Reported Event|HCRI DAPT - BMS 30-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT
597430|NCT00977938|E2|Reported Event|HCRI DAPT - DES 12-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT
597431|NCT00977938|E1|Reported Event|HCRI DAPT - DES 30-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT
597432|NCT00978029|B4|Baseline|Total|Total of all reporting groups
597433|NCT00978029|B3|Baseline|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
597434|NCT00978029|B2|Baseline|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
597435|NCT00978029|B1|Baseline|Placebo|Matching placebo tablet sublingual, once daily
597436|NCT00978029|P3|Participant Flow|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
597437|NCT00978029|P2|Participant Flow|SCH 39641 6 Amb a 1-U|6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an Allergy Immunotherapy Tablet (AIT) sublingual, once daily
597438|NCT00978029|P1|Participant Flow|Placebo|Matching placebo tablet sublingual, once daily
597439|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
597440|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
597441|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
597442|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
597443|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
597449|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
597450|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
597451|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
597452|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
597453|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
597454|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
597455|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
597456|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
597457|NCT00978029|E3|Reported Event|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
597458|NCT00978029|E2|Reported Event|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
597459|NCT00978029|E1|Reported Event|Placebo|Matching placebo tablet sublingual, once daily
597460|NCT00978042|B3|Baseline|Total|Total of all reporting groups
597461|NCT00978042|B2|Baseline|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
597462|NCT00978042|B1|Baseline|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
597463|NCT00978042|P2|Participant Flow|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
597464|NCT00978042|P1|Participant Flow|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
597465|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
597534|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
597467|NCT00978042|O2|Outcome|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
597468|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
597469|NCT00978042|O2|Outcome|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
597470|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
597471|NCT00978042|E2|Reported Event|All Treated Participants_ AEs After Repeat Treatment|All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) and who received re-treatment. AEs reported are AEs with onset after retreatment.
597472|NCT00978042|E1|Reported Event|All Treated Participants_ AEs Initial Treatment|All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). AEs reported are AEs with onset prior to retreatment.
597473|NCT00978120|B5|Baseline|Total|Total of all reporting groups
597474|NCT00978120|B4|Baseline|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597475|NCT00978120|B3|Baseline|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597476|NCT00978120|B2|Baseline|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
597477|NCT00978120|B1|Baseline|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597478|NCT00978120|P4|Participant Flow|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597479|NCT00978120|P3|Participant Flow|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597480|NCT00978120|P2|Participant Flow|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
598137|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
597481|NCT00978120|P1|Participant Flow|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597482|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597483|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597484|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597485|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597486|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597487|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597488|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597489|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597490|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597491|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597492|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597493|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597494|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597495|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597496|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597497|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597498|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597499|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597500|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
598505|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
597501|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597502|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597503|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597504|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597505|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597506|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597507|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597508|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
597535|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
599818|NCT00994760|O1|Outcome|Initial Visit|
597509|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597510|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597511|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597512|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
597513|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597514|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597515|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597516|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
597517|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597518|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
597519|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597520|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
597521|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597522|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
598096|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
597523|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597524|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
597525|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597526|NCT00978120|E4|Reported Event|Severe Asthma, High Dose Vaccine (30mcg)|Participants with severe asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597527|NCT00978120|E3|Reported Event|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597528|NCT00978120|E2|Reported Event|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild/moderate asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597529|NCT00978120|E1|Reported Event|Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg)|Participants with mild/moderate asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
597530|NCT00978341|B1|Baseline|All Subjects|Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning; and Placebo: Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
597531|NCT00978341|P2|Participant Flow|Placebo First Then Pregabalin|First Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. Second Intervention Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
597532|NCT00978341|P1|Participant Flow|Pregabalin First Then Placebo|First Intervention Pregabalin Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. Second Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
597533|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
597541|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
597542|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
597543|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
597544|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
597545|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning
597546|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
597547|NCT00978341|E2|Reported Event|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
597548|NCT00978341|E1|Reported Event|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
597549|NCT00978380|B1|Baseline|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
597550|NCT00978380|P1|Participant Flow|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
597551|NCT00978380|O1|Outcome|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
597552|NCT00978380|O1|Outcome|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
597594|NCT00978627|B2|Baseline|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
598138|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
597553|NCT00978380|E2|Reported Event|rFXIII Avecia|Subjects in this arm received identical dose of 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) administered every 4 weeks (28 days±2 days) until the end of trial for a minimum period of 52 weeks. In the early stage of the trial, a contract manufacturing facility (Avecia) produced the rFXIII drug substance (rFXIII Avecia) and subsequently, Novo Nordisk took over production of the rFXIII drug substance (rFXIII Novo Nordisk). Characterisation testing between the two products confirmed that rFXIII Novo Nordisk and rFXIII Avecia had identical structures, and similar physico-chemical properties. The AE data are presented seperately for rFXIII Novo Nordisk and rFXIII Avecia. However, subjects in this arm received rFXIII Avecia drug.
597554|NCT00978380|E1|Reported Event|rFXIII Novo Nordisk|Subjects in this arm received identical dose of 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) administered every 4 weeks (28 days±2 days) until the end of trial for a minimum period of 52 weeks. In the early stage of the trial, a contract manufacturing facility (Avecia) produced the rFXIII drug substance (rFXIII Avecia) and subsequently, Novo Nordisk took over production of the rFXIII drug substance (rFXIII Novo Nordisk). Characterisation testing between the two products confirmed that rFXIII Novo Nordisk and rFXIII Avecia had identical structures, and similar physico-chemical properties. The AE data are presented seperately for rFXIII Novo Nordisk and rFXIII Avecia. However, subjects in this arm received rFXIII Novo Nordisk drug.
597555|NCT00978432|B4|Baseline|Total|Total of all reporting groups
597556|NCT00978432|B3|Baseline|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.
Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
597557|NCT00978432|B2|Baseline|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597603|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597671|NCT00978757|E1|Reported Event|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
599819|NCT00994760|O1|Outcome|Patients at First Visit|
597558|NCT00978432|B1|Baseline|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597559|NCT00978432|P3|Participant Flow|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.
Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
597560|NCT00978432|P2|Participant Flow|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597561|NCT00978432|P1|Participant Flow|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597562|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.
Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
597563|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
598506|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
597564|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597565|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.
Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
597566|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597567|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
599820|NCT00994760|O1|Outcome|First Visit|
599821|NCT00994760|O2|Outcome|Last Visit (LV)|
597568|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.
Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
597569|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597570|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597571|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.
Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
597572|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597573|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597700|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.
Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
597574|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.
Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
597575|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597576|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597577|NCT00978432|E3|Reported Event|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.
Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
598161|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
597578|NCT00978432|E2|Reported Event|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597579|NCT00978432|E1|Reported Event|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.
Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.
RAD001: 10 mg/day for Part 1 of the trial
LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
597580|NCT00978445|B1|Baseline|All Participants|all participants recieved all interventions during study
597581|NCT00978445|P2|Participant Flow|Standard/Home|all participants recieved home and standard protocol, in this ARM the standard protocol was a in clinic INR and interaction with a care giver, then the Home protocol was as described.
597582|NCT00978445|P1|Participant Flow|Home/Standard|all participants recieved home and standard protocol, in this ARM the home protocol was a virtual INR and communication using a remote communication device called vMetrics.
597583|NCT00978445|O2|Outcome|All Participants - Standard Protocol|all participants recieved all interventions during study
597584|NCT00978445|O1|Outcome|All Participants-home Protocol|all participants recieved all interventions during study
597585|NCT00978445|O2|Outcome|All Particpants - Standard Protocol|First and second group with vMetrics
597586|NCT00978445|O1|Outcome|All Participants-Home Protocol|all participants recieved all interventions during study
597587|NCT00978445|E1|Reported Event|All Participants|all participants recieved all interventions during study
597588|NCT00978562|B1|Baseline|Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium)|"Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.
Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI
Ferumoxytol Non-Stoichiometric Magnetite: Given IV
Gadolinium: Given IV"
597589|NCT00978562|P1|Participant Flow|Ferumoxytol Dynamic Susceptibility (DSC) Weighted MRI and Gado|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
597590|NCT00978562|O1|Outcome|Gadolinium DCE|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
597591|NCT00978562|O1|Outcome|Ferumoxytol DSC MRI|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
597592|NCT00978562|E1|Reported Event|Ferumoxytol DSC and Gad DCE MRI|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
597593|NCT00978627|B3|Baseline|Total|Total of all reporting groups
597595|NCT00978627|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597596|NCT00978627|P2|Participant Flow|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597597|NCT00978627|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597598|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597599|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597600|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597601|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597602|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597718|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597604|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597605|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597606|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597607|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597608|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597609|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597610|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597611|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597612|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597613|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597614|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597615|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597616|NCT00978627|E2|Reported Event|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597617|NCT00978627|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
597618|NCT00978731|B5|Baseline|Total|Total of all reporting groups
597619|NCT00978731|B4|Baseline|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597620|NCT00978731|B3|Baseline|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597621|NCT00978731|B2|Baseline|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597633|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597622|NCT00978731|B1|Baseline|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597623|NCT00978731|P4|Participant Flow|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597624|NCT00978731|P3|Participant Flow|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597625|NCT00978731|P2|Participant Flow|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597626|NCT00978731|P1|Participant Flow|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597627|NCT00978731|O1|Outcome|All Participants|All participants treated in each arm of the study were included.
597628|NCT00978731|O1|Outcome|All Participants|All participants treated in each arm of the study were included.
597629|NCT00978731|O2|Outcome|Participants With CML: BID Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597701|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).
Rosuvastatin: Patients received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
597702|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.
Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharged from study hospital."
616969|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
597630|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597631|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597632|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597634|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597635|NCT00978731|O1|Outcome|Participants With Chronic Myelogenous Leukemia (CML)|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). QD dosing: TDD of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken QD. BID dosing: Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597636|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597637|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597638|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597639|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
616970|NCT01032759|O2|Outcome|Placebo|"Placebo
Placebo: BID"
597640|NCT00978731|O2|Outcome|Participants With CML: BID Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597641|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597642|NCT00978731|O1|Outcome|Participants With Chronic Myelogenous Leukemia (CML)|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). QD dosing: TDD of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken QD. BID dosing: Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597643|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597644|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597645|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597646|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597647|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597648|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597649|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
598139|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
597650|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597651|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597652|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597665|NCT00978757|B1|Baseline|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
597666|NCT00978757|P2|Participant Flow|Placebo|Placebo: saline solution
597667|NCT00978757|P1|Participant Flow|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
597668|NCT00978757|O2|Outcome|Placebo|Placebo: saline solution
597669|NCT00978757|O1|Outcome|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
597670|NCT00978757|E2|Reported Event|Placebo|Placebo: saline solution
597653|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597654|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597655|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597656|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597657|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597658|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597659|NCT00978731|E4|Reported Event|Participants With Myeloid Blast Phase CML|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg ). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597660|NCT00978731|E3|Reported Event|Participants With CML; BID Dosing|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597661|NCT00978731|E2|Reported Event|Participants With Chronic Myelogenous Leukemia(CML);QD Dosing|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules: 5 days, on 2 days off; 6 days on, 1 day off; or continuous daily dosing. Participants were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to twice daily (BID) dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597662|NCT00978731|E1|Reported Event|Participants With Accelerated Phase CML|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg ). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
597663|NCT00978757|B3|Baseline|Total|Total of all reporting groups
597664|NCT00978757|B2|Baseline|Placebo|Placebo: saline solution
597672|NCT00979017|B1|Baseline|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.
Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
597673|NCT00979017|P1|Participant Flow|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.
Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
597674|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.
Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
597675|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.
Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
597703|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).
Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
597704|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.
Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
598140|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
597676|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.
Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
597677|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.
Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
597678|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.
Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
598162|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
597679|NCT00979017|E1|Reported Event|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.
Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
597680|NCT00979069|B3|Baseline|Total|Total of all reporting groups
597681|NCT00979069|B2|Baseline|Control Group|No contact control
597682|NCT00979069|B1|Baseline|Aerobic Group|"12 weeks of aerobic exercise 3 times a week
Aerobic group: 12 weeks of aerobic exercise 3 times a week"
597683|NCT00979069|P2|Participant Flow|Control Group|No contact control
597684|NCT00979069|P1|Participant Flow|Aerobic Group|"12 weeks of aerobic exercise 3 times a week
Aerobic group: 12 weeks of aerobic exercise 3 times a week"
597685|NCT00979069|O2|Outcome|Control Group|No contact control
597686|NCT00979069|O1|Outcome|Aerobic Group|"12 weeks of aerobic exercise 3 times a week
Aerobic group: 12 weeks of aerobic exercise 3 times a week"
597687|NCT00979069|E2|Reported Event|Control Group|No contact control
597688|NCT00979069|E1|Reported Event|Aerobic Group|"12 weeks of aerobic exercise 3 times a week
Aerobic group: 12 weeks of aerobic exercise 3 times a week"
597689|NCT00979121|B3|Baseline|Total|Total of all reporting groups
597690|NCT00979121|B2|Baseline|Placebo|"Half of the patients will be randomized to the placebo.
Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
597691|NCT00979121|B1|Baseline|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.
Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
597692|NCT00979121|P2|Participant Flow|Placebo|"Half of the patients will be randomized to the placebo.
Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
597693|NCT00979121|P1|Participant Flow|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.
Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
597694|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.
Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
597695|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).
Rosuvastatin:Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
597696|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.
Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
597697|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).
Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
597698|NCT00979121|O2|Outcome|Placebo|"Half of the patients will be randomized to the placebo.
Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
597699|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.
Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
597705|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).
Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
597706|NCT00979121|E2|Reported Event|Placebo|"Half of the subjects were randomized to placebo.
Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
597707|NCT00979121|E1|Reported Event|Rosuvastatin|"Half of the subjects were randomized to the active drug (Rosuvastatin).
Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
597708|NCT00979199|B1|Baseline|CTCA and PET or SPECT and ECHO or MRI|
597709|NCT00979199|P1|Participant Flow|CTCA and PET or SPECT and ECHO or MRI|
597710|NCT00979199|O1|Outcome|Non Invasive Cardiac Imaging|All patients are submitted to non invasive cardiac imaging. 'Anatomical' information provided by CTA is obtained in every patient together with the 'functional' information provided by stress radionuclide cardiac imaging (SPECT or PET), to assess myocardial perfusion, and/or by stress MRI or ECHO imaging to assess myocardial contraction. All patients with at least one positive functional test undergo invasive coronary angiography to obtain the final diagnosis of IHD (Outcome measurement).
597711|NCT00979199|E1|Reported Event|Non Invasive Cardiac Imaging|
597712|NCT00979212|B3|Baseline|Total|Total of all reporting groups
597713|NCT00979212|B2|Baseline|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597714|NCT00979212|B1|Baseline|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597715|NCT00979212|P2|Participant Flow|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597716|NCT00979212|P1|Participant Flow|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597717|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597719|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597720|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597721|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597722|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597723|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597724|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597725|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597726|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597727|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597728|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597729|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597730|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597731|NCT00979212|E2|Reported Event|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597732|NCT00979212|E1|Reported Event|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
597733|NCT00985439|B5|Baseline|Total|Total of all reporting groups
597734|NCT00985439|B4|Baseline|Placebo|
597735|NCT00985439|B3|Baseline|Celecoxib 400 mg|
597736|NCT00985439|B2|Baseline|Diclofenac Test (Upper Dose)|
597737|NCT00985439|B1|Baseline|Diclofenac Test (Lower Dose)|
597738|NCT00985439|P4|Participant Flow|Placebo|
597739|NCT00985439|P3|Participant Flow|Celecoxib 400 mg|
597740|NCT00985439|P2|Participant Flow|Diclofenac Test (Upper Dose)|
597741|NCT00985439|P1|Participant Flow|Diclofenac Test (Lower Dose)|
597742|NCT00985439|O4|Outcome|Placebo|
597743|NCT00985439|O3|Outcome|Celecoxib 400 mg|
597744|NCT00985439|O2|Outcome|Diclofenac Test (Upper Dose)|35-mg
597745|NCT00985439|O1|Outcome|Diclofenac Test (Lower Dose)|18-mg
597750|NCT00985491|B1|Baseline|EndoBarrier Liner Device|"46 subjects were enrolled. 3 subjects were implant failures. 43 Subjects received the device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum"
597751|NCT00985491|P1|Participant Flow|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum"
597752|NCT00985491|O1|Outcome|Device|"All patients will be implanted with the Endobarrier Liner device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum"
597753|NCT00985491|O1|Outcome|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum"
597754|NCT00985491|E1|Reported Event|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum"
597755|NCT00985504|B3|Baseline|Total|Total of all reporting groups
597756|NCT00985504|B2|Baseline|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597757|NCT00985504|B1|Baseline|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597758|NCT00985504|P2|Participant Flow|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597759|NCT00985504|P1|Participant Flow|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597760|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597761|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
598163|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
597762|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597763|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597764|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597765|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597766|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597767|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597768|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597769|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597770|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597771|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597772|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597773|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597774|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597775|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597776|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
598141|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
597777|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597778|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597779|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597780|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597781|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597782|NCT00985504|E2|Reported Event|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597783|NCT00985504|E1|Reported Event|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
597784|NCT00985543|B1|Baseline|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
598065|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
599822|NCT00994760|O1|Outcome|Initial Visit (IV)|
597785|NCT00985543|P1|Participant Flow|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
597786|NCT00985543|O3|Outcome|LPV/r 200/50 mg|Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
597787|NCT00985543|O2|Outcome|LPV/r 200/150 mg|Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)
597788|NCT00985543|O1|Outcome|LPV/r 400/100 mg|Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))
597789|NCT00985543|O3|Outcome|LPV/r 200/50 mg|Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
597790|NCT00985543|O2|Outcome|LPV/r 200/150 mg|Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)
597791|NCT00985543|O1|Outcome|LPV/r 400/100 mg|Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))
597792|NCT00985543|E1|Reported Event|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.
597793|NCT00985673|B7|Baseline|Total|Total of all reporting groups
597794|NCT00985673|B6|Baseline|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597795|NCT00985673|B5|Baseline|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597796|NCT00985673|B4|Baseline|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597797|NCT00985673|B3|Baseline|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597798|NCT00985673|B2|Baseline|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598097|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
598142|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
597799|NCT00985673|B1|Baseline|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597800|NCT00985673|P6|Participant Flow|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597801|NCT00985673|P5|Participant Flow|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597802|NCT00985673|P4|Participant Flow|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597803|NCT00985673|P3|Participant Flow|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598066|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
597804|NCT00985673|P2|Participant Flow|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597805|NCT00985673|P1|Participant Flow|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597806|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597807|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597808|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597809|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597810|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597811|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597812|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597813|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598098|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
597814|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597815|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597816|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597817|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597818|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598157|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
597819|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597820|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597821|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597822|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597823|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597824|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597825|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597826|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597827|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597828|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598099|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598342|NCT00986349|P1|Participant Flow|EndoBarrier Liner Device|Enrolled Subjects
597829|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597830|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597831|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597832|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597848|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597833|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597834|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597835|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597836|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597837|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597838|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597839|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597840|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597841|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597842|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597843|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598100|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
616971|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
597844|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597845|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597846|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597847|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597849|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597850|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597851|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597852|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597853|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597854|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597855|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597856|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597857|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597858|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598101|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
597859|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597860|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597861|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597862|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597863|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597864|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597865|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597866|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597867|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597868|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597869|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597870|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597871|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597872|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597873|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598102|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598343|NCT00986349|O1|Outcome|Diabetes|"Single Arm
EndoBarrier Liner: 52 week treatment of EnoBarrier Liner"
597874|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597875|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597876|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597877|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597893|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597878|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597879|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597880|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597881|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597882|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597883|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597884|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597885|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597886|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597887|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597888|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598103|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
616972|NCT01032759|O2|Outcome|Placebo|"Placebo
Placebo: BID"
597889|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597890|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597891|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597892|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597894|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597895|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597896|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597897|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597898|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597899|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597900|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597901|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597902|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597903|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598104|NCT00986102|E4|Reported Event|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
616973|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
597904|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597905|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597906|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597907|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597923|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597908|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597909|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597910|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597911|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597912|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597913|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597914|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597915|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597916|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597917|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597918|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598105|NCT00986102|E3|Reported Event|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
616974|NCT01032759|E2|Reported Event|Placebo|"Placebo
Placebo: BID"
597919|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597920|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597921|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597922|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597924|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597925|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597926|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597927|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597928|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597929|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597930|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597931|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597932|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597933|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598106|NCT00986102|E2|Reported Event|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
616975|NCT01032759|E1|Reported Event|Memantine|Memantine: 20 mg, BID
597934|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597935|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597936|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597937|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597953|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597938|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597939|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597940|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597941|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597942|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597943|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597944|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597945|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597946|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597947|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597948|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598107|NCT00986102|E1|Reported Event|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598108|NCT00986154|B3|Baseline|Total|Total of all reporting groups
597949|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597950|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597951|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597952|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597954|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597955|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597956|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597957|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597958|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597959|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597960|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597961|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597962|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597963|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598130|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598344|NCT00986349|O1|Outcome|EndoBarrier Liner Device|52 week treatment of EndoBarrier Liner
597964|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597965|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597966|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597967|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597982|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597968|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597969|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597970|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597971|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597972|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597973|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597974|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597975|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597976|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597977|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597978|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598131|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598507|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
597979|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597980|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597981|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598061|NCT00986102|P3|Participant Flow|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
598062|NCT00986102|P2|Participant Flow|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
599823|NCT00994760|O1|Outcome|GENISIS|Intranasal Fentanyl Spray
597983|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597984|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597985|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597986|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597987|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597988|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597989|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597990|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597991|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597992|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597993|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598132|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598508|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
597994|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597995|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597996|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597997|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597998|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
597999|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598000|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598001|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598002|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598003|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598004|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598005|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598006|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598007|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598008|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598133|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598509|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
598009|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598010|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598011|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598063|NCT00986102|P1|Participant Flow|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598064|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
599824|NCT00994760|O1|Outcome|Physician Last Visit (LV)|
598012|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598013|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598014|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598015|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598016|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598017|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598018|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598019|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598020|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598021|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598022|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598023|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598134|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598510|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
598024|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598025|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598026|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598027|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598028|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598029|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598030|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598031|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598032|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598033|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598034|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598035|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598036|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598037|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598038|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598135|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598511|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
598039|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598040|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598041|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598042|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598043|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598044|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598045|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598046|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598047|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598048|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598049|NCT00985673|E6|Reported Event|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598050|NCT00985673|E5|Reported Event|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598051|NCT00985673|E4|Reported Event|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598052|NCT00985673|E3|Reported Event|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598053|NCT00985673|E2|Reported Event|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598136|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
616976|NCT01032837|B5|Baseline|Total|Total of all reporting groups
598054|NCT00985673|E1|Reported Event|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
598055|NCT00986102|B5|Baseline|Total|Total of all reporting groups
598056|NCT00986102|B4|Baseline|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
598057|NCT00986102|B3|Baseline|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
598058|NCT00986102|B2|Baseline|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598059|NCT00986102|B1|Baseline|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598060|NCT00986102|P4|Participant Flow|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
598067|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598068|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
598069|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
598070|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598071|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598072|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
598073|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
598074|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598075|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598076|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
598077|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
598078|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598079|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598080|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
598081|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
598082|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598083|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598084|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
598085|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
598086|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598087|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598088|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
598089|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
598090|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598091|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598092|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
598093|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
598094|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598095|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
598109|NCT00986154|B2|Baseline|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
598110|NCT00986154|B1|Baseline|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
598111|NCT00986154|P2|Participant Flow|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
598112|NCT00986154|P1|Participant Flow|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
598158|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598159|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598160|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598113|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
598114|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
598115|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
598116|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
598117|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
598118|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
598119|NCT00986154|E2|Reported Event|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
598120|NCT00986154|E1|Reported Event|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
598121|NCT00986180|B3|Baseline|Total|Total of all reporting groups
598122|NCT00986180|B2|Baseline|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598123|NCT00986180|B1|Baseline|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598124|NCT00986180|P2|Participant Flow|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598125|NCT00986180|P1|Participant Flow|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598126|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598127|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598128|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598129|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598143|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598144|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598145|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598146|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598147|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598148|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598149|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598150|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598151|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598152|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598153|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598154|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598155|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598156|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598164|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598165|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598166|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598167|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598168|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598169|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598170|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598171|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598172|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598173|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598174|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598175|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598176|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598177|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598178|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598179|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598180|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598181|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598182|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598183|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598184|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598185|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598186|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598187|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598188|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598189|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598190|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598191|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598512|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
598192|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598193|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598194|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598195|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598196|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598197|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598198|NCT00986180|E2|Reported Event|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
598199|NCT00986180|E1|Reported Event|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
598200|NCT00986232|B5|Baseline|Total|Total of all reporting groups
598201|NCT00986232|B4|Baseline|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598202|NCT00986232|B3|Baseline|ProQuad™ (High Dose)|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598203|NCT00986232|B2|Baseline|ProQuad™ (Middle Dose)|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598204|NCT00986232|B1|Baseline|ProQuad™ (Low Dose)|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598205|NCT00986232|P4|Participant Flow|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598206|NCT00986232|P3|Participant Flow|ProQuad™ (High Dose)|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598207|NCT00986232|P2|Participant Flow|ProQuad™ (Middle Dose)|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598669|NCT00987623|B2|Baseline|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
598208|NCT00986232|P1|Participant Flow|ProQuad™ (Low Dose)|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598209|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598210|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598211|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598212|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598213|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598214|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598215|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598216|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598217|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598218|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598219|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598220|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598221|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598222|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598223|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598224|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598225|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598226|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598227|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598228|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598229|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598230|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598231|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598232|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598233|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598234|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598235|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598236|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598237|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598238|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598239|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598240|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598241|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598242|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598243|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598244|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598245|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598246|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598247|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598248|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598249|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598250|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598251|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598252|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598253|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598254|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598255|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598256|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598257|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598258|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598259|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598260|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598261|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598262|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598263|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598264|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598265|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598266|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598267|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598268|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598269|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598270|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598271|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598272|NCT00986232|E7|Reported Event|ProQuad (High Dose) After Injection 2|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598273|NCT00986232|E6|Reported Event|ProQuad (Middle Dose) After Injection 2|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598274|NCT00986232|E5|Reported Event|ProQuad (Low Dose) After Injection 2|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598275|NCT00986232|E4|Reported Event|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
598276|NCT00986232|E3|Reported Event|ProQuad (High Dose) After Injection 1|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598277|NCT00986232|E2|Reported Event|ProQuad (Middle Dose) After Injection 1|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598278|NCT00986232|E1|Reported Event|ProQuad (Low Dose) After Injection 1|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
598279|NCT00986245|B1|Baseline|Entire Study Population|Includes groups randomized to receive once daily first and twice daily first.
598280|NCT00986245|P2|Participant Flow|Ropinirole PR-Twice Daily First, Then Once Daily|Ropinirole prolonged release(PR) twice daily in first intervention period and once daily in second intervention period (without washout period)
598281|NCT00986245|P1|Participant Flow|Ropinirole PR-Once Daily First, Then Twice Daily|Ropinirole prolonged release(PR) once daily in first intervention period and twice daily in second intervention period (without washout period)
598282|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598283|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598284|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598285|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598286|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598287|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598288|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598289|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598290|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598291|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598292|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598293|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598294|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598295|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598296|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598297|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598298|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598299|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598300|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598301|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598302|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598303|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598304|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598305|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598306|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole Prolonged release administered in either first intervention peirod or second intervention period.
598307|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole Prolonged release administered in either first intervention peirod or second intervention period.
598308|NCT00986245|O3|Outcome|No Preference|No preference group
598309|NCT00986245|O2|Outcome|Twice-daily|Twice-daily preferred group
598310|NCT00986245|O1|Outcome|Once-daily|Once-daily preferred group
598311|NCT00986245|E2|Reported Event|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598312|NCT00986245|E1|Reported Event|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
598313|NCT00986258|B1|Baseline|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598314|NCT00986258|P1|Participant Flow|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598315|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.
598316|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
598317|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
598318|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.
598319|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
598320|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
598321|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|Subgroup of participants with a score between 19 and 38.
598322|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|Subgroup of participants with a score between 13 and 18.
598323|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|Subgroup of participants with a score between 0 and 12.
598324|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598325|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598326|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598467|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
598327|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598328|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598329|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598330|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598331|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598345|NCT00986349|O3|Outcome|No Change in Glucose-Lowering Meds at Week 52|Subjects who completed 12-month implant duration
598346|NCT00986349|O2|Outcome|Decrease in Glucose-Lowering Meds|Subjects who completed 12-month implant duration
598347|NCT00986349|O1|Outcome|Increase in Glucose-Lowering Meds at Week 52|Subjecst who completed 12 month implant duration
598348|NCT00986349|O5|Outcome|EndoBarrier Liner Device % at 52 Weeks|HbA1c
598349|NCT00986349|O4|Outcome|EndoBarrier Liner Device % at 9 Months|HbA1c
598332|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598333|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598334|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598366|NCT00986401|P2|Participant Flow|Sanctura XR® Then Glucophage® (BA)|Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.
598335|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598336|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598337|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598338|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598339|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598340|NCT00986258|E1|Reported Event|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
598341|NCT00986349|B1|Baseline|EndoBarrier Liner Device|EndoBarrier Liner: 52 week treatment of EndoBarrier Liner
598351|NCT00986349|O2|Outcome|EndoBarrier Liner Device at 3 Months|HbA1c % One subject was removed at day 75 due to non-compliance with attending required visits.
598352|NCT00986349|O1|Outcome|EndoBarrier Liner Device at Baseline|HbA1c %
598353|NCT00986349|E1|Reported Event|EndoBarrier Liner Device|All subjects who had a device attempted to be implanted. N = 23
598354|NCT00986362|B3|Baseline|Total|Total of all reporting groups
598355|NCT00986362|B2|Baseline|Placebo|Placebo : Placebo intravitreal injection
598356|NCT00986362|B1|Baseline|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
598357|NCT00986362|P2|Participant Flow|Placebo|Placebo : Placebo intravitreal injection
598358|NCT00986362|P1|Participant Flow|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
598359|NCT00986362|O2|Outcome|Placebo|Placebo : Placebo intravitreal injection
598360|NCT00986362|O1|Outcome|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
598361|NCT00986362|E2|Reported Event|Placebo|Placebo : Placebo intravitreal injection
598362|NCT00986362|E1|Reported Event|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
598363|NCT00986401|B3|Baseline|Total|Total of all reporting groups
598364|NCT00986401|B2|Baseline|Sanctura XR® Then Glucophage® (BA)|Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.
598365|NCT00986401|B1|Baseline|Glucophage® Then Sanctura XR® (AB)|Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
598465|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
598367|NCT00986401|P1|Participant Flow|Glucophage® Then Sanctura XR® (AB)|Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
598368|NCT00986401|O2|Outcome|Sanctura XR® + Glucophage®|Sanctura XR® + Glucophage®
598369|NCT00986401|O1|Outcome|Sanctura XR®|Sanctura XR®
598370|NCT00986401|O2|Outcome|Glucophage® + Sanctura XR®|Glucophage® + Sanctura XR®
598371|NCT00986401|O1|Outcome|Glucophage®|Glucophage®
598372|NCT00986401|E3|Reported Event|Sanctura XR® in Combination With Glucophage®|Sanctura XR® in combination with Glucophage®
598373|NCT00986401|E2|Reported Event|Sanctura XR®|Sanctura XR®
598374|NCT00986401|E1|Reported Event|Glucophage®|Glucophage®
598375|NCT00986427|B3|Baseline|Total|Total of all reporting groups
598376|NCT00986427|B2|Baseline|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598377|NCT00986427|B1|Baseline|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598378|NCT00986427|P2|Participant Flow|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598379|NCT00986427|P1|Participant Flow|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598380|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598381|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598382|NCT00986427|O4|Outcome|Refresh® Dry Eye Untreated Nail|Refresh® Dry Eye Therapy Untreated Nail
598383|NCT00986427|O3|Outcome|Refresh® Dry Eye Treated Nail|Refresh® Dry Eye Therapy Treated Nail
598384|NCT00986427|O2|Outcome|Restasis® Arm Untreated Nail|Restasis® Untreated Nail
598385|NCT00986427|O1|Outcome|Restasis® Arm Treated Nail|Restasis® Treated Nail
598386|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598387|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598388|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598389|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598390|NCT00986427|E2|Reported Event|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598391|NCT00986427|E1|Reported Event|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
598392|NCT00986453|B1|Baseline|Total Study Population|Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
598393|NCT00986453|P1|Participant Flow|Total Study Population|Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
598394|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
598395|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
599894|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
598396|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
598397|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
598398|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
598399|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
598400|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
598401|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
598402|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
598403|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
598404|NCT00986453|E2|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
598405|NCT00986453|E1|Reported Event|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
598406|NCT00986479|B3|Baseline|Total|Total of all reporting groups
598407|NCT00986479|B2|Baseline|Placebo/AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598408|NCT00986479|B1|Baseline|AZD6765 (150 mg)/ Placebo|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
599825|NCT00994760|O2|Outcome|Last Visit (LV)|
598409|NCT00986479|P2|Participant Flow|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598410|NCT00986479|P1|Participant Flow|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598411|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598412|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598413|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598414|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598415|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598416|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598417|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598418|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598419|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598420|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598421|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598422|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598423|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598455|NCT00986583|B2|Baseline|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
598424|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598425|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598426|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598427|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598428|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598429|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598430|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598466|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
598431|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598432|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598433|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598434|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598435|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598436|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598437|NCT00986479|E2|Reported Event|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
598438|NCT00986479|E1|Reported Event|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
598439|NCT00986544|B3|Baseline|Total|Total of all reporting groups
598440|NCT00986544|B2|Baseline|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
598441|NCT00986544|B1|Baseline|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
598442|NCT00986544|P2|Participant Flow|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
598443|NCT00986544|P1|Participant Flow|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
598444|NCT00986544|O2|Outcome|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
598445|NCT00986544|O1|Outcome|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
598446|NCT00986544|O2|Outcome|Drain|Drain positioned in the subhepatic space after laparoscopic cholecystectomy
598447|NCT00986544|O1|Outcome|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
598448|NCT00986544|E2|Reported Event|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
598449|NCT00986544|E1|Reported Event|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
598450|NCT00986570|B1|Baseline|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:
24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
598451|NCT00986570|P1|Participant Flow|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:
24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
598452|NCT00986570|O1|Outcome|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:
24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
598453|NCT00986570|E1|Reported Event|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:
24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
598454|NCT00986583|B3|Baseline|Total|Total of all reporting groups
598502|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
598456|NCT00986583|B1|Baseline|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
598457|NCT00986583|P2|Participant Flow|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
598458|NCT00986583|P1|Participant Flow|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
598459|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
598460|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
598461|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
598462|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
598463|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
598464|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
598468|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
598469|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
598470|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
598471|NCT00986583|E2|Reported Event|Nonstatin Users|
598472|NCT00986583|E1|Reported Event|Statin Users|
598473|NCT00986674|B4|Baseline|Total|Total of all reporting groups
598474|NCT00986674|B3|Baseline|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV"
598475|NCT00986674|B2|Baseline|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV"
598476|NCT00986674|B1|Baseline|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV"
598477|NCT00986674|P3|Participant Flow|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV"
598478|NCT00986674|P2|Participant Flow|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV"
598479|NCT00986674|P1|Participant Flow|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV"
598503|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
598504|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
598480|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV"
598481|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV"
598482|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV"
598483|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV"
598484|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV"
598542|NCT00986973|B1|Baseline|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day KUVAN for four months.
598573|NCT00986999|E1|Reported Event|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated
rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
598485|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV"
598486|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV"
598487|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV"
598488|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV"
598489|NCT00986674|E3|Reported Event|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
598490|NCT00986674|E2|Reported Event|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
598491|NCT00986674|E1|Reported Event|Arm I (Carboplatin, Paclitaxel, Cetuximab)|Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
598492|NCT00986856|B3|Baseline|Total|Total of all reporting groups
598493|NCT00986856|B2|Baseline|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
598494|NCT00986856|B1|Baseline|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
598495|NCT00986856|P2|Participant Flow|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
598496|NCT00986856|P1|Participant Flow|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
598497|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
598498|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
598499|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
598500|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
598501|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
598513|NCT00986856|E2|Reported Event|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
598514|NCT00986856|E1|Reported Event|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
598515|NCT00986921|B3|Baseline|Total|Total of all reporting groups
598516|NCT00986921|B2|Baseline|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted
Mifepristone 200 mg : mifepristone would be given the day before the procedure
All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
598517|NCT00986921|B1|Baseline|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.
Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.
All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
598518|NCT00986921|P2|Participant Flow|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted
Mifepristone 200 mg : mifepristone would be given the day before the procedure
All women would have the surgical abortion procedure done on the day following mifepristone, by standard surgical technique."
598519|NCT00986921|P1|Participant Flow|Standard Osmotic Dilator Insertion|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.
Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.
All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard surgical technique."
598520|NCT00986921|O2|Outcome|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted
Mifepristone 200 mg : mifepristone would be given the day before the procedure
All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
598572|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated
rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
598574|NCT00987337|B4|Baseline|Total|Total of all reporting groups
598521|NCT00986921|O1|Outcome|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.
Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.
All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
598522|NCT00986921|O2|Outcome|Mifepristone|Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted
598523|NCT00986921|O1|Outcome|Standard Osmotic Dilators|Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.
598524|NCT00986921|O2|Outcome|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted. No osmotic dilators are used.
Mifepristone 200 mg : mifepristone would be given the day before the procedure
All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
598525|NCT00986921|O1|Outcome|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.
Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.
All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
598526|NCT00986921|E2|Reported Event|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted
Mifepristone 200 mg : mifepristone would be given the day before the procedure
All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
598527|NCT00986921|E1|Reported Event|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.
Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.
All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
598528|NCT00986947|B1|Baseline|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.
If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
598529|NCT00986947|P1|Participant Flow|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.
If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
598530|NCT00986947|O1|Outcome|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.
If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
598531|NCT00986947|O1|Outcome|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.
If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
598559|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
598560|NCT00986986|O1|Outcome|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
598532|NCT00986947|E1|Reported Event|IvIg With Rituximab|"Intravenous immunoglobulin (IVIg) and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.
If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
598533|NCT00986960|B3|Baseline|Total|Total of all reporting groups
598534|NCT00986960|B2|Baseline|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
598535|NCT00986960|B1|Baseline|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
598536|NCT00986960|P2|Participant Flow|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
598537|NCT00986960|P1|Participant Flow|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
598538|NCT00986960|O2|Outcome|Placebo|Saline: I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
598539|NCT00986960|O1|Outcome|Adrenocorticotropin Hormone|repository corticotropin injection: IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
598540|NCT00986960|E2|Reported Event|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
598541|NCT00986960|E1|Reported Event|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
598543|NCT00986973|P1|Participant Flow|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
598544|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
598545|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
598546|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
598547|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
598548|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
598549|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
598550|NCT00986973|O1|Outcome|Sapropterin (KUVAN) Therapy|All subjects received KUVAN at a dose of 20/mg/kg/day for four months. Blood Phe levels were measured drawn before therapy and 4 months after starting therapy.
598551|NCT00986973|E1|Reported Event|Sapropterin (KUVAN) Therapy|All subjects will received KUVAN therapy 20 mg/kg/day for four months.
598552|NCT00986986|B3|Baseline|Total|Total of all reporting groups
598553|NCT00986986|B2|Baseline|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
598554|NCT00986986|B1|Baseline|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
598555|NCT00986986|P2|Participant Flow|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
598556|NCT00986986|P1|Participant Flow|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
598557|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
598558|NCT00986986|O1|Outcome|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
598561|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
598562|NCT00986986|O1|Outcome|Extended Release Niacin|HIV infected individuals receiving extended release niacin
598563|NCT00986986|E2|Reported Event|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
598564|NCT00986986|E1|Reported Event|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
598565|NCT00986999|B1|Baseline|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated
rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
598566|NCT00986999|P1|Participant Flow|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated
rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
598567|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated
rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
598568|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated
rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
598569|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated
rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
598570|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated
rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
598571|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated
rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
598575|NCT00987337|B3|Baseline|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598576|NCT00987337|B2|Baseline|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598577|NCT00987337|B1|Baseline|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598578|NCT00987337|P3|Participant Flow|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598579|NCT00987337|P2|Participant Flow|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598589|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598944|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598580|NCT00987337|P1|Participant Flow|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 milligram (mg) tablet orally twice daily as blinded therapy along with pegylated interferon alpha-2a (pegIFN alpha-2a) 180 microgram (mcg) subcutaneously once weekly and ribavirin (RBV) 1000 milligram per day (mg/day) to participants weighing less than or equal to(<=) 75 kilogram (kg) or RBV 1200 mg/day to participants weighing greater than (>) 75 kg, orally in 2 divided doses up to Week 24. Participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) (HCV RNA <15 international units/milliliter [IU/mL]) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (greater than or equal to [>=] 15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75kg or RBV 1200 mg/day if participant weighed >75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598581|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598582|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598633|NCT00987415|B2|Baseline|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598634|NCT00987415|B1|Baseline|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598836|NCT00988143|P2|Participant Flow|Study Group 2 (2008-2009 TIV)|Participants received the 2008-2009 Trivalent Influenza Vaccine
598583|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598584|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598585|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598586|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598587|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598588|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598590|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598984|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598591|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598592|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598593|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598635|NCT00987415|P2|Participant Flow|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598594|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598595|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598596|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598597|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598598|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598599|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598600|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598903|NCT00988221|P3|Participant Flow|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598601|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598602|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598603|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598604|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598605|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598606|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598607|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598608|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598609|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72.
598610|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72.
598611|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598769|NCT00987935|E3|Reported Event|Phase I Group I Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
598612|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598613|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598614|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598615|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598616|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598617|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598618|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598619|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598620|NCT00987337|E3|Reported Event|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
598621|NCT00987337|E2|Reported Event|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598865|NCT00988143|E3|Reported Event|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
598622|NCT00987337|E1|Reported Event|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
598623|NCT00987402|B3|Baseline|Total|Total of all reporting groups
598624|NCT00987402|B2|Baseline|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
598625|NCT00987402|B1|Baseline|Plain Soap and Water|Surgical hand preparation with plain soap and water
598626|NCT00987402|P2|Participant Flow|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
598627|NCT00987402|P1|Participant Flow|Plain Soap and Water|Surgical hand preparation with plain soap and water
598628|NCT00987402|O2|Outcome|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
598629|NCT00987402|O1|Outcome|Plain Soap and Water|Surgical hand preparation with plain soap and water
598630|NCT00987402|E2|Reported Event|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
598631|NCT00987402|E1|Reported Event|Plain Soap and Water|Surgical hand preparation with plain soap and water
598632|NCT00987415|B3|Baseline|Total|Total of all reporting groups
598668|NCT00987623|B3|Baseline|Total|Total of all reporting groups
601228|NCT00998023|B1|Baseline|Mynx VCD|Mynx Vascular Closure Device
598636|NCT00987415|P1|Participant Flow|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598637|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598638|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598639|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598640|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598641|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598642|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598643|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598644|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598645|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598646|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598647|NCT00987415|E2|Reported Event|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598648|NCT00987415|E1|Reported Event|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
598649|NCT00987467|B1|Baseline|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.
Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
598650|NCT00987467|P1|Participant Flow|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.
Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
598651|NCT00987467|O1|Outcome|Topical Steroid Resistant/Dependant AKC|Patients with topical steroid resistant or dependant AKC were used for this study.
598652|NCT00987467|O1|Outcome|Patients With Steroid Resistant/ Dependant AKC.|Ten patients with significant AKC either steroid dependent or resistant who were having active inflammation were enrolled in this study.
598741|NCT00987935|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598653|NCT00987467|E1|Reported Event|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.
Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
598654|NCT00987558|B1|Baseline|Eslicarbazepine Acetate + Simvastatin|"Simvastatin 80 mg + eslicarbazepine acetate 800 mg
Simvastatin + ESL: Oral single-dose of simvastatin 80 mg on two occasions ─ once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days ─ separated by a washout period of 3 weeks or more."
598655|NCT00987558|P2|Participant Flow|ESL, Then Simvastatin|Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day Washout period - 3 weeks Simvastatin 80 mg - Oral single-dose administered alone
598656|NCT00987558|P1|Participant Flow|Simvastatin, Then ESL + Simvastatin|Simvastatin 80 mg - Oral single-dose administered alone Washout period - 3 weeks Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day
598657|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
598658|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
598659|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
598660|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
598661|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
598662|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
598663|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
598664|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
598665|NCT00987558|E3|Reported Event|Eslicarbazepine Acetate + Simvastatin|Simvastatin 80 mg + eslicarbazepine acetate 800 mg
598666|NCT00987558|E2|Reported Event|Eslicarbazepine Acetate|eslicarbazepine acetate 800 mg
598667|NCT00987558|E1|Reported Event|Simvastatin|Simvastatin 80 mg
598670|NCT00987623|B1|Baseline|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
598671|NCT00987623|P2|Participant Flow|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
598672|NCT00987623|P1|Participant Flow|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
598673|NCT00987623|O2|Outcome|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
598674|NCT00987623|O1|Outcome|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
598675|NCT00987623|E2|Reported Event|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
598676|NCT00987623|E1|Reported Event|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
598677|NCT00987727|B3|Baseline|Total|Total of all reporting groups
598678|NCT00987727|B2|Baseline|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
598679|NCT00987727|B1|Baseline|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
598680|NCT00987727|P2|Participant Flow|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
598681|NCT00987727|P1|Participant Flow|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
598682|NCT00987727|O2|Outcome|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
598683|NCT00987727|O1|Outcome|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
598684|NCT00987727|O2|Outcome|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
598685|NCT00987727|O1|Outcome|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
598686|NCT00987727|E2|Reported Event|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
598687|NCT00987727|E1|Reported Event|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
598688|NCT00987831|B4|Baseline|Total|Total of all reporting groups
598689|NCT00987831|B3|Baseline|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
598690|NCT00987831|B2|Baseline|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies
Blood drawing and brief history only : No treatments given"
598691|NCT00987831|B1|Baseline|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppresion vs themselves serving as their own control flaring later....not on immune suppression.
599895|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
598692|NCT00987831|P3|Participant Flow|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
598693|NCT00987831|P2|Participant Flow|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies
Blood drawing and brief history only : No treatments given"
598694|NCT00987831|P1|Participant Flow|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppression vs themselves serving as their own control flaring later....not on immune suppression.
598695|NCT00987831|O2|Outcome|Moderate Disease Activity at Baseline|this is fully explained above. Moderate disease is now defined as BILAG < 17 in cumulative score
598696|NCT00987831|O1|Outcome|Severe Disease Activity at Baseline|This is fully explained above. Severe disease is now defined as total cumulative BILAG score >/= 17
598697|NCT00987831|O2|Outcome|Moderate Disease Activity at Baseline|this is fully explained above. Moderate disease activity is defined as up to 3 BILAG B, no A, and SLEDAI </= 10.
598698|NCT00987831|O1|Outcome|Severe Disease Activity at Baseline|This is fully explained above. Severe disease activity is defined as > 3 BILAG B, OR at least one BILAG A or SLEDAI > 10 OR Meets Definition for severe Flare on SELENA SLEDAI
598699|NCT00987831|E3|Reported Event|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
598700|NCT00987831|E2|Reported Event|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies
Blood drawing and brief history only : No treatments given"
598701|NCT00987831|E1|Reported Event|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppression vs themselves serving as their own control flaring later....not on immune suppression.
598702|NCT00987935|B10|Baseline|Total|Total of all reporting groups
598703|NCT00987935|B9|Baseline|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598704|NCT00987935|B8|Baseline|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598705|NCT00987935|B7|Baseline|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598706|NCT00987935|B6|Baseline|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598707|NCT00987935|B5|Baseline|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598708|NCT00987935|B4|Baseline|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598709|NCT00987935|B3|Baseline|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598710|NCT00987935|B2|Baseline|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598711|NCT00987935|B1|Baseline|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
598712|NCT00987935|P9|Participant Flow|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598742|NCT00987935|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598713|NCT00987935|P8|Participant Flow|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598714|NCT00987935|P7|Participant Flow|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598715|NCT00987935|P6|Participant Flow|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598716|NCT00987935|P5|Participant Flow|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598717|NCT00987935|P4|Participant Flow|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598718|NCT00987935|P3|Participant Flow|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598719|NCT00987935|P2|Participant Flow|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598720|NCT00987935|P1|Participant Flow|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
598721|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
598722|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
598723|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
598724|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
598725|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
598726|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
598727|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
598728|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
598729|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
598730|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
598731|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
598732|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
598733|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
598734|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
598735|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598736|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598737|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598738|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598739|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598740|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
599896|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
598743|NCT00987935|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598744|NCT00987935|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598745|NCT00987935|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598746|NCT00987935|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598747|NCT00987935|O1|Outcome|Phase I Group 1, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
598748|NCT00987935|O9|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598749|NCT00987935|O8|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598750|NCT00987935|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598751|NCT00987935|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598752|NCT00987935|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598753|NCT00987935|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598754|NCT00987935|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598755|NCT00987935|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
598756|NCT00987935|O1|Outcome|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
598757|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598758|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598759|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598760|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
598761|NCT00987935|O2|Outcome|Group 2|"Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
598762|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
598763|NCT00987935|E9|Reported Event|Phase II Sorafenib, 400 mg Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid) during Phase II
598764|NCT00987935|E8|Reported Event|Phase II Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) during Phase II
598765|NCT00987935|E7|Reported Event|Phase I Group II Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
598766|NCT00987935|E6|Reported Event|Phase I Group II Nintedanib, 150 mg Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
598767|NCT00987935|E5|Reported Event|Phase I Group II Nintedanib, 100 mg Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
598768|NCT00987935|E4|Reported Event|Phase I Group II Nintedanib, 50 mg Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
598866|NCT00988143|E2|Reported Event|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
598770|NCT00987935|E2|Reported Event|Phase I Group I Nintedanib, 150 mg Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
598771|NCT00987935|E1|Reported Event|Phase I Group I Nintedanib, 100 mg Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
598772|NCT00987948|B1|Baseline|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
598773|NCT00987948|P1|Participant Flow|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
598774|NCT00987948|O1|Outcome|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
598775|NCT00987948|O1|Outcome|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
598776|NCT00987948|E1|Reported Event|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
598777|NCT00988065|B4|Baseline|Total|Total of all reporting groups
598778|NCT00988065|B3|Baseline|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598779|NCT00988065|B2|Baseline|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598780|NCT00988065|B1|Baseline|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598781|NCT00988065|P3|Participant Flow|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598782|NCT00988065|P2|Participant Flow|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598783|NCT00988065|P1|Participant Flow|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598784|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598785|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
599826|NCT00994760|O1|Outcome|First Visit (FV): Patients With Previous BTP- Medication Only|
598786|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598787|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598788|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598789|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598790|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598791|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598792|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598793|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598794|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598795|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598796|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598797|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598798|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598799|NCT00988065|E3|Reported Event|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598800|NCT00988065|E2|Reported Event|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598801|NCT00988065|E1|Reported Event|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
598802|NCT00988091|B3|Baseline|Total|Total of all reporting groups
598803|NCT00988091|B2|Baseline|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
598804|NCT00988091|B1|Baseline|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
598805|NCT00988091|P2|Participant Flow|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
599897|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
598806|NCT00988091|P1|Participant Flow|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
598807|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
598808|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
598809|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
598810|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
598811|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
598837|NCT00988143|P1|Participant Flow|Study Group 1 (2009-2010 TIV)|Participants received the 2009-2010 Trivalent Influenza Vaccine (Pediatric dose with no preservatives)
598812|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
598813|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
598814|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
598815|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
598816|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
598817|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
598818|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
598819|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
598820|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
598821|NCT00988091|E3|Reported Event|IA-BioHA: Open-label Period|Participants had the option of continuing into the open-label period in which their target knee received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) and they were followed for an additional 26 weeks.
598822|NCT00988091|E2|Reported Event|IA-BioHA: Double-blind Period|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period.
598867|NCT00988143|E1|Reported Event|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
598823|NCT00988091|E1|Reported Event|IA-SA: Double-blind Period|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period.
598824|NCT00988117|B1|Baseline|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
598825|NCT00988117|P1|Participant Flow|Rivastigmine|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
598826|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
598827|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
598828|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
598829|NCT00988117|E2|Reported Event|Rivastigmine 9.5 mg/24 Hours|The Exelon patch was administered at a dosage of 9.5 mg/24 hours from week 4 to 12.
598830|NCT00988117|E1|Reported Event|Rivastigmine 4.6mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4.
598831|NCT00988143|B4|Baseline|Total|Total of all reporting groups
598832|NCT00988143|B3|Baseline|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
598833|NCT00988143|B2|Baseline|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
598834|NCT00988143|B1|Baseline|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
598835|NCT00988143|P3|Participant Flow|Study Group 3 (QIV)|Participants received the Quadrivalent Influenza Vaccine
598838|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
598839|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
598840|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
598841|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
598842|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
598843|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
598844|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
598845|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
598846|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
598847|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
598848|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
598849|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
598850|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
598851|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
598852|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
598853|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
598854|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
598855|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
598856|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
598857|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
598858|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
598859|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
598860|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
598861|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
598862|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
598863|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
598864|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
598869|NCT00988156|B2|Baseline|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL or matching placebo. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
598870|NCT00988156|B1|Baseline|Placebo|Placebo matching placebo
598871|NCT00988156|P2|Participant Flow|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
598872|NCT00988156|P1|Participant Flow|Placebo|Placebo matching placebo
598873|NCT00988156|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
598874|NCT00988156|O1|Outcome|Placebo|Placebo matching placebo
598875|NCT00988156|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
598876|NCT00988156|O1|Outcome|Placebo|Placebo matching placebo
598877|NCT00988156|E2|Reported Event|Esl (Safety Set Part I)|
598878|NCT00988156|E1|Reported Event|Placebo (Safety Set Part I)|
598879|NCT00988169|B1|Baseline|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
598880|NCT00988169|P1|Participant Flow|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
598881|NCT00988169|O1|Outcome|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
598882|NCT00988169|E1|Reported Event|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
598883|NCT00988208|B3|Baseline|Total|Total of all reporting groups
598884|NCT00988208|B2|Baseline|Docetaxel + Prednisone + Lenalidomide (DPL)|The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
598885|NCT00988208|B1|Baseline|Oral Placebo + Docetaxel IV Day 1 + Prednisone (DP)|The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
599827|NCT00994760|O1|Outcome|Last Visit|
599828|NCT00994760|O2|Outcome|Last Visit|
598886|NCT00988208|P2|Participant Flow|Docetaxel/Prednisone/Lenalidomide (DPL)|The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
598887|NCT00988208|P1|Participant Flow|Docetaxel/Prednisone/Placebo (DP)|The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
598888|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1;5 mg prednisone orally twice each day (BID) each day of a 21 day treatment cycle
598889|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP treatment arm: Oral placebo once each day (QD) on Days 1-14 of a 21 days treatment cycle plus 75 mg/m^2 docetaxel intravenous (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) of a 21 day treatment cycle
598890|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL-The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
598891|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP-The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
598892|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL-The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
598893|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP-The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
598894|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL-The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
598895|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP-The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
598896|NCT00988208|E2|Reported Event|Lenalidomide/Docetaxel/Prednisone (DPL)|The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
598897|NCT00988208|E1|Reported Event|Docetaxel/Prednisone/Placebo (DP)|The 21-day treatment regimen consisted of: Identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel IV on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
598898|NCT00988221|B4|Baseline|Total|Total of all reporting groups
598899|NCT00988221|B3|Baseline|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598900|NCT00988221|B2|Baseline|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598901|NCT00988221|B1|Baseline|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598902|NCT00988221|P4|Participant Flow|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
599898|NCT00995345|O1|Outcome|Placebo|Tablet
598904|NCT00988221|P2|Participant Flow|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598905|NCT00988221|P1|Participant Flow|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598906|NCT00988221|O3|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598907|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598908|NCT00988221|O1|Outcome|Placebo to Tocilizumab|Patients received placebo to tocilizumab intravenously every 4 weeks.
598909|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598910|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598911|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598912|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598913|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598914|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598915|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598916|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598917|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598918|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598919|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598920|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598921|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598922|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598923|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598924|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598925|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598926|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598927|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598928|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598929|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598930|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598931|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598932|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598933|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598934|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598935|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598936|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598937|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598938|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598939|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598940|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598941|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598942|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598943|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599899|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
598945|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598946|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598947|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598948|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598949|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598950|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598951|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598952|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598953|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598954|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598955|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598956|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598957|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598958|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598959|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599829|NCT00994760|O1|Outcome|Initial Visit|
599830|NCT00994760|O2|Outcome|Study End|
598960|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598961|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598962|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598963|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598964|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598965|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598966|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598967|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598968|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598969|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598970|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598971|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598972|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598973|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598974|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598975|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598976|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598977|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598978|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598979|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598980|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598981|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598982|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598983|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599900|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
598985|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598986|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598987|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598988|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598989|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598990|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598991|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
598992|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
598993|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
598994|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598995|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
598996|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598997|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
598998|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
598999|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
599000|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599001|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
599002|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599003|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
599004|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599005|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
599006|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599007|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
599008|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599009|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
599010|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599011|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
599012|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599013|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599014|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599015|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599016|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599017|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599018|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599019|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599020|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599021|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599022|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599023|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599024|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599025|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599026|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599027|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599028|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599029|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599030|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599031|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599032|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599033|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599034|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599035|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599036|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599037|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599038|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599039|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599040|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599041|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599042|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599043|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599044|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599045|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599046|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599047|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599048|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599049|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599831|NCT00994760|O1|Outcome|Study Start|
599832|NCT00994760|E1|Reported Event|All Patients Treated|
599050|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599051|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599052|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599053|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599054|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599055|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599056|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599057|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599058|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599059|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599060|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599061|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599062|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599063|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599064|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599065|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599066|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599067|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599068|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599069|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
599070|NCT00988221|E5|Reported Event|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
599071|NCT00988221|E4|Reported Event|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599072|NCT00988221|E3|Reported Event|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
599073|NCT00988221|E2|Reported Event|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
599074|NCT00988221|E1|Reported Event|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
599075|NCT00988247|B3|Baseline|Total|Total of all reporting groups
599076|NCT00988247|B2|Baseline|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
599077|NCT00988247|B1|Baseline|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
599078|NCT00988247|P2|Participant Flow|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
599079|NCT00988247|P1|Participant Flow|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
599080|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
599081|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
599082|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
599083|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
599084|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
599085|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
599086|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
599087|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
599088|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
599089|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
599090|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
599091|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
599092|NCT00988247|E2|Reported Event|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
599093|NCT00988247|E1|Reported Event|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
599094|NCT00988325|B4|Baseline|Total|Total of all reporting groups
599095|NCT00988325|B3|Baseline|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599096|NCT00988325|B2|Baseline|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599097|NCT00988325|B1|Baseline|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
599098|NCT00988325|P3|Participant Flow|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days.
599099|NCT00988325|P2|Participant Flow|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599100|NCT00988325|P1|Participant Flow|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
599101|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599102|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599103|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
599104|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599105|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599106|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
599107|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599108|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599109|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
599110|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599111|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599112|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
599113|NCT00988325|O3|Outcome|Type B|Genotype B was present in 12, 2, and 2 participants of age groups <365 days, 31 to 90 days, and <=30 days, respectively.
599114|NCT00988325|O2|Outcome|Type A H3|Genotype Type A H3 was present in 4 participants and 6 participants of age groups 91 to <365 days and 31 to 90 days, respectively
599115|NCT00988325|O1|Outcome|Type A (H1N1)pdm09|Genotype A (H1N1)pdm09 was present in 21 participants of age group 91 to <365 days, 9 participants of age group 31 to 90 days, and 2 participants of age group <=30 days
599116|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599117|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599118|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
599119|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599120|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599121|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
599122|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599123|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599124|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
599125|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599126|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599127|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
599128|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599129|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599130|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
599131|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599132|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599133|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
599134|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599135|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599136|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
599137|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599138|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599139|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
599140|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599141|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599142|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
599143|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599144|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599145|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
599146|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599147|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599148|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
599149|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599150|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
599151|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
599152|NCT00988325|E3|Reported Event|Oseltamivir 2 mg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
599153|NCT00988325|E2|Reported Event|Oseltamivir 2.5 mg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/ twice a day for 5 days
599154|NCT00988325|E1|Reported Event|Oseltamivir 3 mg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
599155|NCT00988351|B3|Baseline|Total|Total of all reporting groups
599156|NCT00988351|B2|Baseline|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.
Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
599157|NCT00988351|B1|Baseline|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment
Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
599158|NCT00988351|P2|Participant Flow|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.
Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
599159|NCT00988351|P1|Participant Flow|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment
Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
599160|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.
Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
599161|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment
Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
599162|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.
Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
599163|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment
Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
599164|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.
Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
599165|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment
Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
599166|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.
Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
599167|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment
Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
599168|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.
Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
599169|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment
Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
599170|NCT00988351|E2|Reported Event|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.
Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
599171|NCT00988351|E1|Reported Event|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment
Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
599172|NCT00988429|B4|Baseline|Total|Total of all reporting groups
599173|NCT00988429|B3|Baseline|1200 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
599174|NCT00988429|B2|Baseline|800 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
599175|NCT00988429|B1|Baseline|Placebo|Matching placebo tablets QD orally
599176|NCT00988429|P3|Participant Flow|1200 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
599223|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599325|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
599177|NCT00988429|P2|Participant Flow|800 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
599178|NCT00988429|P1|Participant Flow|Placebo|Matching placebo tablets QD orally
599179|NCT00988429|O3|Outcome|ESL 1200 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
599180|NCT00988429|O2|Outcome|ESL 800 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
599181|NCT00988429|O1|Outcome|Placebo|Matching placebo tablets QD orally
599182|NCT00988429|O3|Outcome|ESL 1200 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
599183|NCT00988429|O2|Outcome|ESL 800 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
599184|NCT00988429|O1|Outcome|Placebo (ITT Population)|Matching placebo tablets QD orally
599185|NCT00988429|E3|Reported Event|ESL 1200 mg QD (Safety Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
599186|NCT00988429|E2|Reported Event|ESL 800 mg QD (Safety Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
599187|NCT00988429|E1|Reported Event|Placebo (Safety Population)|Matching placebo tablets QD orally
599188|NCT00988442|B3|Baseline|Total|Total of all reporting groups
599189|NCT00988442|B2|Baseline|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599190|NCT00988442|B1|Baseline|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599599|NCT00994214|P4|Participant Flow|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
599191|NCT00988442|P2|Participant Flow|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599192|NCT00988442|P1|Participant Flow|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599193|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Usual ACTG site care."
599194|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Usual ACTG site care."
599195|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Usual ACTG site care."
599196|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Usual ACTG site care."
599197|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Usual ACTG site care."
599198|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Usual ACTG site care."
599199|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599200|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599201|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599202|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599203|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599243|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599326|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
599901|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
599204|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599205|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599206|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599207|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599208|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599209|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599389|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599210|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599211|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599212|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599213|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599214|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599215|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599216|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599217|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599218|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599219|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this may vary by study site."
599220|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599221|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599222|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599224|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599225|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599226|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599227|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599228|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599229|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599230|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599231|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599232|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599233|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599234|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599235|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599236|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599237|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599238|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599239|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599240|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599241|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599242|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599244|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599245|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599246|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599247|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599248|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
599249|NCT00988442|E2|Reported Event|Standard Care|"Participants will receive care as usual.
Standard care: Care as usual for participants starting a new ART regimen; this may vary by study site."
599250|NCT00988442|E1|Reported Event|Enhanced Nursing Telephone Support With Standard Care|"Participants will receive enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses may schedule more frequent calls at their discretion. Calls will provide information, motivational enhancement, problem-solving skills, and affective support.
Standard care: Care as usual for participants starting a new ART regimen; this may vary by study site."
599251|NCT00988533|B1|Baseline|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599252|NCT00988533|P1|Participant Flow|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599253|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599254|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599255|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599256|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599257|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599258|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599259|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599260|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599261|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599262|NCT00988533|E1|Reported Event|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
599263|NCT00982280|B1|Baseline|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599264|NCT00982280|P1|Participant Flow|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599265|NCT00982280|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599266|NCT00982280|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599647|NCT00994240|B1|Baseline|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
599267|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599268|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599269|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599596|NCT00994214|B3|Baseline|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
599270|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599271|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599272|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599273|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599274|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599275|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599276|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599318|NCT00982423|P2|Participant Flow|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
599319|NCT00982423|P1|Participant Flow|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
599277|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599278|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599279|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599280|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599281|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599282|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599283|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599284|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599285|NCT00982280|E1|Reported Event|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
599286|NCT00982345|B1|Baseline|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
599287|NCT00982345|P1|Participant Flow|Seroquel XR|Seroquel XR (quetiapine) starting dose 50 mg and increased up to 400 mg as tolerated) treatment.
599288|NCT00982345|O1|Outcome|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
599289|NCT00982345|E1|Reported Event|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
599290|NCT00982410|B3|Baseline|Total|Total of all reporting groups
599320|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
599321|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
599291|NCT00982410|B2|Baseline|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599292|NCT00982410|B1|Baseline|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599293|NCT00982410|P2|Participant Flow|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599364|NCT00982592|B1|Baseline|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599294|NCT00982410|P1|Participant Flow|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor Veterans Affairs Medical Center (VAMC). Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599295|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599296|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599297|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599298|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599299|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599300|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599301|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599302|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599322|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
599323|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
599324|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
599303|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599304|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599305|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599306|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599307|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599308|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599309|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599310|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599311|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599312|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599313|NCT00982410|E2|Reported Event|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
599314|NCT00982410|E1|Reported Event|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse
Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
599315|NCT00982423|B3|Baseline|Total|Total of all reporting groups
599316|NCT00982423|B2|Baseline|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
599317|NCT00982423|B1|Baseline|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
599736|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
599327|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
599328|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
599329|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
599330|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
599331|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
599332|NCT00982423|E2|Reported Event|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
599333|NCT00982423|E1|Reported Event|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
599334|NCT00982488|B6|Baseline|Total|Total of all reporting groups
599365|NCT00982592|P2|Participant Flow|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
601438|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
599335|NCT00982488|B5|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599336|NCT00982488|B4|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB|Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599337|NCT00982488|B3|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599338|NCT00982488|B2|Baseline|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599339|NCT00982488|B1|Baseline|Dasatinib 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599340|NCT00982488|P5|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599341|NCT00982488|P4|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB|Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599342|NCT00982488|P3|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599343|NCT00982488|P2|Participant Flow|Imatinib, 400 mg BID, Chronic Phase|Participants chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599344|NCT00982488|P1|Participant Flow|Dasatinib 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599902|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
599345|NCT00982488|O5|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599346|NCT00982488|O4|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP|Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599347|NCT00982488|O3|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599348|NCT00982488|O2|Outcome|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib twice daily (BID). Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599349|NCT00982488|O1|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599350|NCT00982488|E5|Reported Event|Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599351|NCT00982488|E4|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP|Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599352|NCT00982488|E3|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599353|NCT00982488|E2|Reported Event|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599354|NCT00982488|E1|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
599355|NCT00982553|B1|Baseline|All Subjects|"All subjects received the same study therapy as follows:
Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.
Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
599356|NCT00982553|P1|Participant Flow|All Subjects|"All subjects received the same study therapy as follows:
Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.
Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
599357|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
599358|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
599516|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
599359|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
599360|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
599361|NCT00982553|E1|Reported Event|All Subjects|"All subjects received the same study therapy as follows:
Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.
Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
599362|NCT00982592|B3|Baseline|Total|Total of all reporting groups
599363|NCT00982592|B2|Baseline|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
601439|NCT00998374|E2|Reported Event|Non-pyloric Sparing|Non-pyloric: RYGB
599366|NCT00982592|P1|Participant Flow|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599367|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599368|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599369|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599370|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599371|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599372|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599373|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599374|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599375|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599376|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599377|NCT00982592|E2|Reported Event|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599378|NCT00982592|E1|Reported Event|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
599379|NCT00982644|B3|Baseline|Total|Total of all reporting groups
599380|NCT00982644|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599381|NCT00982644|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599382|NCT00982644|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599517|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
599903|NCT00995345|O1|Outcome|Placebo|Tablet
599383|NCT00982644|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599384|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599385|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599386|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599387|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599388|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599390|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599391|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599392|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599393|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599394|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599395|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599396|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599397|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599398|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599399|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599400|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599401|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599402|NCT00982644|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599403|NCT00982644|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
599404|NCT00982657|B5|Baseline|Total|Total of all reporting groups
599405|NCT00982657|B4|Baseline|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599406|NCT00982657|B3|Baseline|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599518|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
599407|NCT00982657|B2|Baseline|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599408|NCT00982657|B1|Baseline|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599409|NCT00982657|P4|Participant Flow|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599410|NCT00982657|P3|Participant Flow|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599411|NCT00982657|P2|Participant Flow|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599412|NCT00982657|P1|Participant Flow|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599413|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599414|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599415|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599416|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599417|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599418|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599419|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599420|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599421|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599422|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599423|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599424|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599425|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599426|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599519|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
599427|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent occurred or investigator's discretion.
599428|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599429|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
599430|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
599431|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
599432|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
601440|NCT00998374|E1|Reported Event|Pyloric-sparing|Pyloric: SG & DS
599433|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599434|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599435|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599436|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599437|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599438|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599439|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599440|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599441|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599442|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599443|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599444|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599445|NCT00982657|O1|Outcome|All Participants|All participants who received 6 mg/kg, 12mg/kg or 15 mg/kg of CVX-060 intravenous infusion along with oral 50 mg or 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599446|NCT00982657|E4|Reported Event|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599520|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
618991|NCT01037244|O4|Outcome|Placebo|Placebo tablets
599447|NCT00982657|E3|Reported Event|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599448|NCT00982657|E2|Reported Event|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599449|NCT00982657|E1|Reported Event|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
599450|NCT00982735|B1|Baseline|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
599451|NCT00982735|P1|Participant Flow|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
599452|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
599453|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
599454|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
599455|NCT00982735|E1|Reported Event|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
599456|NCT00988637|B3|Baseline|Total|Total of all reporting groups
599457|NCT00988637|B2|Baseline|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599458|NCT00988637|B1|Baseline|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599459|NCT00988637|P2|Participant Flow|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599460|NCT00988637|P1|Participant Flow|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599461|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599462|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599463|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599464|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599465|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599466|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599467|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599468|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599469|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599470|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599471|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599472|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599473|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599474|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599475|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599476|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599737|NCT00994461|E3|Reported Event|Placebo|Placebo tablet three times a day with meal for 2 weeks
599477|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599478|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599479|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599480|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599481|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599482|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599483|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599484|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599597|NCT00994214|B2|Baseline|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
599485|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599486|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599487|NCT00988637|E2|Reported Event|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
599488|NCT00988637|E1|Reported Event|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
599489|NCT00988832|B1|Baseline|Infliximab|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
599490|NCT00988832|P1|Participant Flow|Infliximab|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
599491|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
599492|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
599493|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
599494|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
599495|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
599496|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
599497|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
599498|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
599499|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
599500|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
599501|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
599502|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
599503|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
599504|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
599505|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
599506|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
599507|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
599508|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
599509|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
599510|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
599511|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
599512|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
599513|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
599514|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
599515|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
599521|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
599522|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
599523|NCT00988832|E1|Reported Event|INFLIXIMAB, RECOMBINANT|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
599524|NCT00988858|B1|Baseline|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599525|NCT00988858|P1|Participant Flow|LY2603618 and Pemetrexed|"LY2603618: 150 milligram per square meter mg/m^2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression
Pemetrexed: 500mg/m^2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599526|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599527|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599598|NCT00994214|B1|Baseline|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
599528|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599529|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599530|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599531|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599532|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599533|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599534|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599535|NCT00988858|E1|Reported Event|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
599536|NCT00988884|B3|Baseline|Total|Total of all reporting groups
599537|NCT00988884|B2|Baseline|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599538|NCT00988884|B1|Baseline|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
599539|NCT00988884|P2|Participant Flow|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599540|NCT00988884|P1|Participant Flow|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
599541|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599542|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
599543|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599544|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
618992|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
599545|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599546|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
599547|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599548|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
599549|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599550|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
599551|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599552|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
599553|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599554|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
599555|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599556|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
599557|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599558|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
599559|NCT00988884|E2|Reported Event|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
599560|NCT00988884|E1|Reported Event|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
599561|NCT00994110|B3|Baseline|Total|Total of all reporting groups
599562|NCT00994110|B2|Baseline|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.
Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
599563|NCT00994110|B1|Baseline|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
599580|NCT00994123|O1|Outcome|HRG High: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
599581|NCT00994123|O2|Outcome|Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
daily 150 mg erlotinib p.o. alone"
599564|NCT00994110|P2|Participant Flow|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.
Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
599565|NCT00994110|P1|Participant Flow|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
599566|NCT00994110|O2|Outcome|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.
Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
599567|NCT00994110|O1|Outcome|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
599568|NCT00994110|E2|Reported Event|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.
Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
599569|NCT00994110|E1|Reported Event|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
599570|NCT00994123|B4|Baseline|Total|Total of all reporting groups
599571|NCT00994123|B3|Baseline|Phase 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
daily 150 mg erlotinib p.o. alone"
599572|NCT00994123|B2|Baseline|Phase 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
599573|NCT00994123|B1|Baseline|Phase 1: MM-121 + Erlotinib|Escalating doses of MM-121 + Erlotinib in patients with NSCLC
599574|NCT00994123|P3|Participant Flow|Phase 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
daily 150 mg erlotinib p.o. alone"
599575|NCT00994123|P2|Participant Flow|Phase 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
599576|NCT00994123|P1|Participant Flow|Phase 1: MM-121 + Erlotinib|Escalating doses of MM-121 and erlotinib
599577|NCT00994123|O4|Outcome|HRG Low: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
599578|NCT00994123|O3|Outcome|HRG Low: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
daily 150 mg erlotinib p.o. alone"
599579|NCT00994123|O2|Outcome|HRG High: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
daily 150 mg erlotinib p.o. alone"
599582|NCT00994123|O1|Outcome|MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
599583|NCT00994123|O1|Outcome|Phase 1: All Participants|All participants in the dose escalation portion of the Phase 1
599584|NCT00994123|O7|Outcome|Cohort 7|MM-121 20 mg/kg (Q3W IV) + erlotinib 100 mg (PO daily)
599585|NCT00994123|O6|Outcome|Cohort 6|MM-121 20 mg/kg (Q2W IV) + erlotinib 100 mg (PO daily)
599586|NCT00994123|O5|Outcome|Cohort 5|MM-121 20 mg/kg (weekly IV) + erlotinib 100 mg (PO daily)
599587|NCT00994123|O4|Outcome|Cohort 4|MM-121 12 mg/kg (Q2W IV) + 150 mg erlotinib (PO daily)
599588|NCT00994123|O3|Outcome|Cohort 3|MM-121 12 mg/kg (Q2W IV) + 100 mg erlotinib (daily PO)
599589|NCT00994123|O2|Outcome|Cohort 2|6 mg/kg MM-121 Q2W + 150 mg erlotinib (daily PO)
599590|NCT00994123|O1|Outcome|Cohort 1|MM-121 6 mk/kg (Q2W IV) and 100 mg erlotinib (daily PO)
599591|NCT00994123|E3|Reported Event|Ph 1: MM-121 + Erlotinib|Escalating Doses of MM-121 + erlotinib
599592|NCT00994123|E2|Reported Event|Ph 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
daily 150 mg erlotinib p.o. alone"
599593|NCT00994123|E1|Reported Event|Ph 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:
MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
599594|NCT00994214|B5|Baseline|Total|Total of all reporting groups
599595|NCT00994214|B4|Baseline|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections..
601750|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
599600|NCT00994214|P3|Participant Flow|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
599601|NCT00994214|P2|Participant Flow|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
599602|NCT00994214|P1|Participant Flow|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
599603|NCT00994214|O9|Outcome|Overall - Part B|
599604|NCT00994214|O8|Outcome|Part B: Arm D: BIM 23A760 6 mg|
599605|NCT00994214|O7|Outcome|Part B: Arm C: BIM 23A760 4 mg|
599606|NCT00994214|O6|Outcome|Part B: Arm B: BIM 23A760 2 mg|
599607|NCT00994214|O5|Outcome|Overall - Part A|
599608|NCT00994214|O4|Outcome|Part A: Arm D: BIM 23A760 6 mg|
599609|NCT00994214|O3|Outcome|Part A: Arm C: BIM 23A760 4 mg|
599610|NCT00994214|O2|Outcome|Part A: Arm B: BIM 23A760 2 mg|
599611|NCT00994214|O1|Outcome|Part A: Arm A: BIM 23A760 1 mg|
599612|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
599613|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
599614|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
599615|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
599616|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
599617|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
599618|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
599619|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
599620|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
599621|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections
599622|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections
599623|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections
599624|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections
599625|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections
599626|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
599627|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
599628|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
599629|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
599630|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
599631|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
599632|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
599633|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
599634|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
599635|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
599636|NCT00994214|E9|Reported Event|Overall - Part B|
599637|NCT00994214|E8|Reported Event|Part B: Arm D: BIM 23A760 6 mg|
599638|NCT00994214|E7|Reported Event|Part B: Arm C: BIM 23A760 4 mg|
599639|NCT00994214|E6|Reported Event|Part B: Arm B: BIM 23A760 2 mg|
599640|NCT00994214|E5|Reported Event|Overall - Part A|
599641|NCT00994214|E4|Reported Event|Part A: Arm D: BIM 23A760 6 mg|
599642|NCT00994214|E3|Reported Event|Part A: Arm C: BIM 23A760 4 mg|
599643|NCT00994214|E2|Reported Event|Part A: Arm B: BIM 23A760 2 mg|
599644|NCT00994214|E1|Reported Event|Part A: Arm A: BIM 23A760 1 mg|
599645|NCT00994240|B3|Baseline|Total|Total of all reporting groups
599646|NCT00994240|B2|Baseline|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
599648|NCT00994240|P2|Participant Flow|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
599649|NCT00994240|P1|Participant Flow|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
599650|NCT00994240|O2|Outcome|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
599651|NCT00994240|O1|Outcome|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
599652|NCT00994240|E2|Reported Event|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
599653|NCT00994240|E1|Reported Event|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
599654|NCT00994253|B3|Baseline|Total|Total of all reporting groups
599655|NCT00994253|B2|Baseline|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.
Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg
Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
599656|NCT00994253|B1|Baseline|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.
Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg
Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
599691|NCT00994422|P1|Participant Flow|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
599692|NCT00994422|O2|Outcome|Vehicle Control|Participants received a single application of vehicle control cream on Day 1.
599657|NCT00994253|P2|Participant Flow|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.
Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg
Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
599658|NCT00994253|P1|Participant Flow|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.
Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg
Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
599659|NCT00994253|O2|Outcome|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.
Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg
Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
599660|NCT00994253|O1|Outcome|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.
Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg
Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
599661|NCT00994253|E2|Reported Event|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.
Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg
Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
599662|NCT00994253|E1|Reported Event|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.
Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg
Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
599663|NCT00994279|B3|Baseline|Total|Total of all reporting groups
599664|NCT00994279|B2|Baseline|Arm 2: Educational Wellness Group|"Educational Wellness Group
Education: Educational Wellness Group"
599665|NCT00994279|B1|Baseline|Arm 1: Yoga Intervention|"Yoga Intervention
Yoga: Yoga sessions"
599666|NCT00994279|P2|Participant Flow|Arm 2: Educational Wellness Group|"Educational Wellness Group
Education: Educational Wellness Group"
599667|NCT00994279|P1|Participant Flow|Arm 1: Yoga Intervention|"Yoga Intervention
Yoga: Yoga sessions"
599668|NCT00994279|O2|Outcome|Arm 2: Educational Wellness Group|"Educational Wellness Group
Education: Educational Wellness Group"
599669|NCT00994279|O1|Outcome|Arm 1: Yoga Intervention|"Yoga Intervention
Yoga: Yoga sessions"
599670|NCT00994279|O2|Outcome|Arm 2: Educational Wellness Group|"Educational Wellness Group
Education: Educational Wellness Group"
599671|NCT00994279|O1|Outcome|Arm 1: Yoga Intervention|"Yoga Intervention
Yoga: Yoga sessions"
599672|NCT00994279|E2|Reported Event|Arm 2: Educational Wellness Group|"Educational Wellness Group
Education: Educational Wellness Group"
599673|NCT00994279|E1|Reported Event|Arm 1: Yoga Intervention|"Yoga Intervention
Yoga: Yoga sessions"
599674|NCT00994318|B4|Baseline|Total|Total of all reporting groups
599675|NCT00994318|B3|Baseline|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
599676|NCT00994318|B2|Baseline|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
618993|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
599677|NCT00994318|B1|Baseline|FCM (High Ferritin Target|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
599678|NCT00994318|P3|Participant Flow|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
599679|NCT00994318|P2|Participant Flow|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
599680|NCT00994318|P1|Participant Flow|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
599681|NCT00994318|O3|Outcome|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
599682|NCT00994318|O2|Outcome|FCM (Low Ferritin Level)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 100-200 mcg/L
599683|NCT00994318|O1|Outcome|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 400-600 mcg/L
599684|NCT00994318|E3|Reported Event|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
599685|NCT00994318|E2|Reported Event|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
599686|NCT00994318|E1|Reported Event|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
599687|NCT00994422|B3|Baseline|Total|Total of all reporting groups
599688|NCT00994422|B2|Baseline|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
599689|NCT00994422|B1|Baseline|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
599690|NCT00994422|P2|Participant Flow|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
599693|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin cream on Day 1.
599694|NCT00994422|O2|Outcome|Vehicle Control|Participants received a single application of vehicle control cream on Day 1.
599695|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin cream on Day 1.
599696|NCT00994422|O2|Outcome|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
599697|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
599698|NCT00994422|E2|Reported Event|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
599699|NCT00994422|E1|Reported Event|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
599700|NCT00994448|B3|Baseline|Total|Total of all reporting groups
599701|NCT00994448|B2|Baseline|Placebo (Sugar Pill)|Matching placebo tablets twice a day
599702|NCT00994448|B1|Baseline|Bupropion|Bupropion SR 150 mg twice a day
599703|NCT00994448|P2|Participant Flow|Placebo (Sugar Pill)|Matching placebo tablets twice a day
599704|NCT00994448|P1|Participant Flow|Bupropion|Bupropion SR 150 mg twice a day
599705|NCT00994448|O2|Outcome|Placebo (Sugar Pill)|Matching placebo tablets twice a day
599706|NCT00994448|O1|Outcome|Bupropion|Bupropion SR 150 mg twice a day
599707|NCT00994448|E2|Reported Event|Placebo (Sugar Pill)|Matching placebo tablets twice a day
599708|NCT00994448|E1|Reported Event|Bupropion|Bupropion SR 150 mg twice a day
599709|NCT00994461|B4|Baseline|Total|Total of all reporting groups
599710|NCT00994461|B3|Baseline|Placebo|Placebo tablet three times a day with meal for 2 weeks
599711|NCT00994461|B2|Baseline|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
599712|NCT00994461|B1|Baseline|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
599713|NCT00994461|P3|Participant Flow|Placebo|Placebo tablet three times a day with meal for 2 weeks
599714|NCT00994461|P2|Participant Flow|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
599715|NCT00994461|P1|Participant Flow|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
599716|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
599717|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
599718|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
599719|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
599720|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
599721|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
599722|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
599723|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
599724|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
599725|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
599726|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
599727|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
599728|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
599729|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
599730|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
599731|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
599732|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
599733|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
599734|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
599735|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
599738|NCT00994461|E2|Reported Event|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
599739|NCT00994461|E1|Reported Event|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
599740|NCT00994604|B1|Baseline|Broccoli Sprout Extract|broccoli sprout extract: consumption of broccoli sprout extract for 2 weeks
599741|NCT00994604|P1|Participant Flow|Broccoli Sprout Extract|pre- and post-consumption of broccoli sprout extract for 2 weeks
599742|NCT00994604|O2|Outcome|Airway Size Post BSE|CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
599743|NCT00994604|O1|Outcome|Airway Size Pre BSE|CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
599744|NCT00994604|O2|Outcome|Broccoli Sprout Extract - BD|pre- and post-consumption of broccoli sprout extract for 2 weeks
599745|NCT00994604|O1|Outcome|Broccoli Sprout Extract - BP|pre- and post-consumption of broccoli sprout extract for 2 weeks
599746|NCT00994604|E1|Reported Event|Broccoli Sprout Extract|pre- and post-consumption of broccoli sprout extract for 2 weeks
599747|NCT00994682|B3|Baseline|Total|Total of all reporting groups
599748|NCT00994682|B2|Baseline|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599862|NCT00995020|P1|Participant Flow|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ (straight wire excision of the transformation zone), which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
599749|NCT00994682|B1|Baseline|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599750|NCT00994682|P2|Participant Flow|Pioglitazone|After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or T2DM and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d).
599751|NCT00994682|P1|Participant Flow|Placebo|After all participants receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on placebo (or pioglitazone) in a randomized, double-blind,placebo-controlled study design by the research pharmacy. Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills.
599752|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).
Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.
Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
599753|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).
Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months
Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
599754|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).
Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.
Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
599755|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).
Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months
Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
599756|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).
Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.
Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
599904|NCT00995345|E5|Reported Event|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
599757|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).
Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months
Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
599758|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).
Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.
Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
599770|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599863|NCT00995020|O2|Outcome|SWETZ|SWETZ uses a 1cm straight 0.20mm wire to fashion a similar excision.
599759|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).
Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months
Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
599760|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599761|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599762|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599763|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599764|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599765|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599766|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599767|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599905|NCT00995345|E4|Reported Event|Dose 3: KRP-104|100 mg QD
599906|NCT00995345|E3|Reported Event|Dose 2: KRP-104|80 mg QD
599768|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599769|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599798|NCT00994760|O1|Outcome|Caregiver at Final Visit|
599771|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599772|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599773|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599774|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599775|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599776|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599777|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599778|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599790|NCT00994682|E4|Reported Event|Pioglitazone (Months 18-36)|After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599907|NCT00995345|E2|Reported Event|Dose 1: KRP-104|40 mg QD
599779|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599780|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599799|NCT00994760|O1|Outcome|Caregiver at Final Visit|
599800|NCT00994760|O1|Outcome|Patients at Final Visit|
599801|NCT00994760|O1|Outcome|Patients at Final Visit|
599802|NCT00994760|O2|Outcome|Last Visit (LV)|
599803|NCT00994760|O1|Outcome|First Visit (FV)(Patients With Previous BTP-medication Only)|
599804|NCT00994760|O1|Outcome|Patients at Final Visit|
599805|NCT00994760|O2|Outcome|Last Visit|
599781|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599782|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599783|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599784|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599785|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599786|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599787|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599788|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
599789|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599884|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
599885|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
599791|NCT00994682|E3|Reported Event|Placebo (PIO Open-label)|After being randomized to placebo for the first 18 months, patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
599792|NCT00994682|E2|Reported Event|Pioglitazone (First 18 Months)|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d).
599793|NCT00994682|E1|Reported Event|Placebo (First 18 Months)|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills.
599794|NCT00994760|B1|Baseline|GENISIS|Intranasal Fentanyl Spray
599795|NCT00994760|P1|Participant Flow|GENISIS|Intranasal Fentanyl Spray
599796|NCT00994760|O1|Outcome|Caregiver at Final Visit|
599797|NCT00994760|O1|Outcome|Caregiver at Final Visit|
599833|NCT00994929|B1|Baseline|Neumega (Oprelveken, Interleukin 11)|The VWD subjects included two with type 1 VWD and two with type 2 VWD, including one with type 2B, with increased platelet aggregation at low strength ristocetin and absent high molecular weight multimers, and one with type 2M disease, with reduced VWF:RCoF/ VWF:Ag ratio <0.50, per NHLBI criteria (Table 2).5 All subjects had positive past bleeding histories. Pregnancy, lactation, heart disease, uncontrolled hypertension, arrhythmia, thrombosis, recent surgery or receipt of blood products were exclusions. A total of nine subjects were enrolled and completed study, including five with hemophilia A and four with VWD. The median age was 26 years, range 22-51 years
599834|NCT00994929|P1|Participant Flow|Neumega (Oprelveken, Interleukin 11)|25 µg/kilogram of body weight of rhIL-11 subcutaneously administered on days 1 to 4. On day 4 following rhIL-11 injection DDAVP was subsequently given at 0.3 mcg/kg intravenously over 30 minutes. For any subject with past allergic reactions, hypersensitivity, or seizures with DDAVP, or in whom DDAVP is contraindicated, DDAVP was not given: only rhIL-11 was given on Day 4.
599835|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|"Neumega (Oprelveken, interleukin-11 (IL-11) 25 microgram/kilogram by subcutaneou injection once daily for four days, followed on day 4 DDAVP 0.3 microgram/kilogram intravenously 30 minutes after neumega
Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11."
599836|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|"Neumega (Oprelveken, interleukin-11 (IL-11) 25 microgram/kilogram by subcutaneou injection once daily for four days, followed on day 4 DDAVP 0.3 microgram/kilogram intravenously 30 minutes after neumega
Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11."
599837|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11.
599838|NCT00994929|E1|Reported Event|Neumega (Oprelveken, Interleukin 11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed on day 4 by DDAVP 0.3 microgram/kg by intravenous infusion.
599839|NCT00995007|B3|Baseline|Total|Total of all reporting groups
599840|NCT00995007|B2|Baseline|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
599886|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
599887|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
599841|NCT00995007|B1|Baseline|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
599842|NCT00995007|P2|Participant Flow|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
599843|NCT00995007|P1|Participant Flow|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
599844|NCT00995007|O3|Outcome|Cross Over to Vandetanib|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
599845|NCT00995007|O2|Outcome|Vandetanib With Carboplatin|"Sequential Group (carboplatin followed by vandetanib)
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
599846|NCT00995007|O1|Outcome|Carboplatin|"Combo Group (both drugs together)
ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
599864|NCT00995020|O1|Outcome|LLETZ - Cone|LLETZ - cone was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
599847|NCT00995007|O4|Outcome|Anaplastic Astrocytoma (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
599848|NCT00995007|O3|Outcome|Anaplastic Astrocytoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
599849|NCT00995007|O2|Outcome|Glioblastoma (Carboplation Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
599850|NCT00995007|O1|Outcome|Glioblastoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
599851|NCT00995007|O4|Outcome|Anaplastic Astrocytomas (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
599852|NCT00995007|O3|Outcome|Anaplastic Astrocytomas (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
599853|NCT00995007|O2|Outcome|Glioblastoma (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
599888|NCT00995345|O1|Outcome|Placebo|Tablet
599889|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
599854|NCT00995007|O1|Outcome|Glioblastoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
599855|NCT00995007|E3|Reported Event|Crossover to Vandetanib|ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
599856|NCT00995007|E2|Reported Event|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
599857|NCT00995007|E1|Reported Event|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
599858|NCT00995020|B3|Baseline|Total|Total of all reporting groups
599859|NCT00995020|B2|Baseline|LLETZ Cone - Loop Excision of TZ Cone Biopsy|The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
599860|NCT00995020|B1|Baseline|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
599861|NCT00995020|P2|Participant Flow|LLETZ Cone: Large Loop Excision of Transformation Zone - Cone|The standard procedure, LLETZ - cone (large loop excision of tranformation zone used as cone biopsy), was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ (transformation zone) and brought slowly to just outside the controlateral transformation zone margin with the ambition of removing 20-25 mm length of endocervical epithelium.
600034|NCT00995670|O3|Outcome|Statin and Glucose|To determine the effect of simvastatin on modulating the I/R injury during the normal glucose state and during hyperglycemia.
599865|NCT00995020|O2|Outcome|LLETZ Cone|LLETZ cone,the standard procedure is performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
599866|NCT00995020|O1|Outcome|SWETZ|SWETZ (Straight wire excision of the transformation zone), the experimental intervention, is a cone biopsy procedure that uses a 1cm X 0.20mm straight wire to fashion a cone excision,with the ambition of removing 20-25 mm length of endocervical epithelium. Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
599867|NCT00995020|E2|Reported Event|LLETZ Cone - Loop Excision of TZ Cone Biopsy|The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
599868|NCT00995020|E1|Reported Event|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
599869|NCT00995085|B1|Baseline|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
599870|NCT00995085|P1|Participant Flow|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
599871|NCT00995085|O1|Outcome|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
599872|NCT00995085|E1|Reported Event|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
599873|NCT00995345|B6|Baseline|Total|Total of all reporting groups
599874|NCT00995345|B5|Baseline|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
599875|NCT00995345|B4|Baseline|Dose 3: KRP-104|100 mg QD
599876|NCT00995345|B3|Baseline|Dose 2: KRP-104|80 mg QD
599877|NCT00995345|B2|Baseline|Dose 1: KRP-104|40 mg QD
599878|NCT00995345|B1|Baseline|Placebo|Tablet
599879|NCT00995345|P5|Participant Flow|Dose 4: KRP-104|20 mg /120 mg QD (dose switch at week12)
599880|NCT00995345|P4|Participant Flow|Dose 3: KRP-104|100 mg QD
599881|NCT00995345|P3|Participant Flow|Dose 2: KRP-104|80 mg QD
599882|NCT00995345|P2|Participant Flow|Dose 1: KRP-104|40 mg QD
599883|NCT00995345|P1|Participant Flow|Placebo|Tablet
599910|NCT00995371|B2|Baseline|Epidural Steroid Injection|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
599911|NCT00995371|B1|Baseline|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
599912|NCT00995371|P2|Participant Flow|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, when unblinded, were given option to cross-over to and receive the mild procedure using the mild device kit
599913|NCT00995371|P1|Participant Flow|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
599914|NCT00995371|O2|Outcome|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, after unblinding, were given option to cross-over to and receive the mild procedure using the mild device kit.
599915|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
599916|NCT00995371|O2|Outcome|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, after unblinding, were given option to cross-over to and receive the mild procedure using the mild device kit.
599917|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
599918|NCT00995371|O2|Outcome|Epidural Steroid Injection Prior to Cross-Over|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
599919|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
599920|NCT00995371|O2|Outcome|Epidural Steroid Injection Prior to Cross-Over|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
599921|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
599922|NCT00995371|E3|Reported Event|ESI Cross-over to Lumbar Decompression With Mild|Group 3: Patients in the Epidural Steroid Injection (ESI) group treated by the physicians in accordance with product labeling and indications for use, crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure
599923|NCT00995371|E2|Reported Event|Epidural Steroid Injection|"Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
The ESI group analyzed crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure"
599924|NCT00995371|E1|Reported Event|Vertos Mild® Minimally-Invasive Lumbar Decompression|Group 1: Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
599925|NCT00995410|B1|Baseline|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily
PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
599926|NCT00995410|P1|Participant Flow|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily
PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
599927|NCT00995410|O1|Outcome|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily
PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
599928|NCT00995410|O1|Outcome|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily
PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
599929|NCT00995410|E1|Reported Event|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily
PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
599930|NCT00995436|B4|Baseline|Total|Total of all reporting groups
599931|NCT00995436|B3|Baseline|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch
Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars"
599932|NCT00995436|B2|Baseline|Miniscrews|"Placement of micro-screw to supplement anchorage
Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws"
599933|NCT00995436|B1|Baseline|Headgear|"Placement of extraoral traction to be worn 100 hours per week
Extraoral anchorage : Extra oral anchorage using headgear"
599934|NCT00995436|P3|Participant Flow|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch
Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars"
599935|NCT00995436|P2|Participant Flow|Miniscrews|"Placement of micro-screw to supplement anchorage
Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws"
599936|NCT00995436|P1|Participant Flow|Headgear|"Placement of extraoral traction to be worn 100 hours per week
Extraoral anchorage : Extra oral anchorage using headgear"
599937|NCT00995436|O3|Outcome|Headgear|
599938|NCT00995436|O2|Outcome|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch
Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars"
599939|NCT00995436|O1|Outcome|Miniscrews|"Device Placement of micro-screw to supplement anchorage
Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws"
599940|NCT00995436|E3|Reported Event|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch
Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars"
599941|NCT00995436|E2|Reported Event|Miniscrews|"Device Placement of micro-screw to supplement anchorage
Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws"
599942|NCT00995436|E1|Reported Event|Headgear|"Device Placement of extraoral traction to be worn 100 hours per week
Extraoral anchorage: Extra oral anchorage"
599943|NCT00995449|B5|Baseline|Total|Total of all reporting groups
599944|NCT00995449|B4|Baseline|Placebo|Placebo comparator
599945|NCT00995449|B3|Baseline|KB003 600 mg|600 mg, KB003 a monoclonal antibody
599946|NCT00995449|B2|Baseline|KB003 200 mg|Dose group not evaluated in this portion of study
599947|NCT00995449|B1|Baseline|KB003 70mg|Dose group not evaluated in this portion of study
599948|NCT00995449|P4|Participant Flow|Placebo|Placebo comparator
599949|NCT00995449|P3|Participant Flow|KB003 600 mg|600 mg, KB003 a monoclonal antibody
599950|NCT00995449|P2|Participant Flow|KB003 200 mg|Dose group not evaluated in this portion of study
599951|NCT00995449|P1|Participant Flow|KB003 70mg|Dose group not evaluated in this portion of study
599952|NCT00995449|O2|Outcome|Placebo|Placebo comparator
599953|NCT00995449|O1|Outcome|KB003 600 mg|600 mg, KB003 a monoclonal antibody
599954|NCT00995449|E4|Reported Event|Placebo|Placebo comparator
599955|NCT00995449|E3|Reported Event|KB003 600 mg|600 mg, KB003 a monoclonal antibody
599956|NCT00995449|E2|Reported Event|KB003 200 mg|Dose group not evaluated in this portion of study
599957|NCT00995449|E1|Reported Event|KB003 70mg|Dose group not evaluated in this portion of study
599958|NCT00995488|B1|Baseline|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
599959|NCT00995488|P1|Participant Flow|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
599960|NCT00995488|O1|Outcome|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
599961|NCT00995488|O1|Outcome|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
599962|NCT00995488|E1|Reported Event|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
599963|NCT00995501|B9|Baseline|Total|Total of all reporting groups
599964|NCT00995501|B8|Baseline|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599965|NCT00995501|B7|Baseline|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
600035|NCT00995670|O2|Outcome|Vitamin C and Glucose|To determine if vitamin C can restore the impairment of the endothelium caused by the dextrose infusion.
599966|NCT00995501|B6|Baseline|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599967|NCT00995501|B5|Baseline|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599968|NCT00995501|B4|Baseline|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
599969|NCT00995501|B3|Baseline|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
anesthesia management: Light anesthesia to maintain BIS about 55
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
599970|NCT00995501|B2|Baseline|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
601702|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
599971|NCT00995501|B1|Baseline|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55"
599972|NCT00995501|P8|Participant Flow|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599973|NCT00995501|P7|Participant Flow|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
599974|NCT00995501|P6|Participant Flow|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599975|NCT00995501|P5|Participant Flow|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599976|NCT00995501|P4|Participant Flow|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
601229|NCT00998023|P2|Participant Flow|AngioSeal VCD|AngioSeal Vascular Closure Device
599977|NCT00995501|P3|Participant Flow|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
anesthesia management: Light anesthesia to maintain BIS about 55
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
599978|NCT00995501|P2|Participant Flow|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599979|NCT00995501|P1|Participant Flow|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55"
599980|NCT00995501|O8|Outcome|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599981|NCT00995501|O7|Outcome|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
600057|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
599982|NCT00995501|O6|Outcome|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599983|NCT00995501|O5|Outcome|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599984|NCT00995501|O4|Outcome|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
599985|NCT00995501|O3|Outcome|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
anesthesia management: Light anesthesia to maintain BIS about 55
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
599986|NCT00995501|O2|Outcome|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599987|NCT00995501|O1|Outcome|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55"
601751|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
599988|NCT00995501|O8|Outcome|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599989|NCT00995501|O7|Outcome|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
599990|NCT00995501|O6|Outcome|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599991|NCT00995501|O5|Outcome|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599992|NCT00995501|O4|Outcome|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
600058|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
600059|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
599993|NCT00995501|O3|Outcome|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
anesthesia management: Light anesthesia to maintain BIS about 55
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
599994|NCT00995501|O2|Outcome|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599995|NCT00995501|O1|Outcome|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55"
599996|NCT00995501|E8|Reported Event|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599997|NCT00995501|E7|Reported Event|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
600012|NCT00995553|O1|Outcome|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.
Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
600101|NCT00995865|B3|Baseline|Placebo Group|This third group of 12 subjects were to receive a placebo (0.9% normal saline for injection).
599998|NCT00995501|E6|Reported Event|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
599999|NCT00995501|E5|Reported Event|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
600000|NCT00995501|E4|Reported Event|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
600001|NCT00995501|E3|Reported Event|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
anesthesia management: Light anesthesia to maintain BIS about 55
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
600002|NCT00995501|E2|Reported Event|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
600003|NCT00995501|E1|Reported Event|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55"
600004|NCT00995553|B3|Baseline|Total|Total of all reporting groups
601703|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
600005|NCT00995553|B2|Baseline|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.
Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
600006|NCT00995553|B1|Baseline|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.
Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
600007|NCT00995553|P2|Participant Flow|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.
Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
600008|NCT00995553|P1|Participant Flow|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.
Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
600009|NCT00995553|O2|Outcome|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.
Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
600010|NCT00995553|O1|Outcome|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.
Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
600011|NCT00995553|O2|Outcome|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.
Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
601230|NCT00998023|P1|Participant Flow|Mynx VCD|Mynx Vascular Closure Device
600013|NCT00995553|E2|Reported Event|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.
Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
600014|NCT00995553|E1|Reported Event|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.
Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
600015|NCT00995566|B1|Baseline|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600016|NCT00995566|P1|Participant Flow|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600017|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600018|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600019|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600020|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600021|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600022|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600023|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600024|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600025|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600026|NCT00995566|E1|Reported Event|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
600027|NCT00995670|B4|Baseline|Total|Total of all reporting groups
600060|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
600061|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
600028|NCT00995670|B3|Baseline|Statin and Glucose|"Volunteers ingested a 40 mg simvastatin (statin) pill for the two evenings prior to study day and the morning of the study to determine the effect of simvastatin on modulating the I/R injury during hyperglycemia (high glucose). Volunteers were studied with statin alone and with statin and glucose.
Placebo data were the placebo studies from the Sevoflurane and Glucose arm, when appropriate; new subjects (not enrolled in Sevoflurane and Glucose arm) underwent a separate placebo trial.
Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min.
Statin: 40 mg of simvastatin 17 volunteers were studied 31 times in this arm."
600029|NCT00995670|B2|Baseline|Vitamin C and Glucose|"To determine if vitamin C can restore the impairment of the endothelium (FBF) caused by the glucose (dextrose infusion). All subjects received glucose and I/R injury (ischemia), either with or without vitamin C. Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
Placebo data were the placebo studies from the Sevoflurane and Glucose arm, when appropriate; new subjects (not enrolled in Sevoflurane and Glucose arm) underwent a separate placebo trial.
Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min.
Vitamin C: 1 gm iv bolus injection 5 min before I/R injury 16 volunteers were studied 25 times in this arm."
600030|NCT00995670|B1|Baseline|Sevoflurane and Glucose|"Endothelial function will be measured via forearm blood flow (FBF). Subjects may get I/R injury (ischemia) without glucose or sevoflurane (placebo trial); I/R with glucose only (glucose trial); I/R with sevoflurane only (sevoflurane trial); I/R with glucose and sevoflurane (combined trial). Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min to prevent the anesthetic preconditioning (sevoflurane) protection against subsequent I/R injury.
Sevoflurane: 1 minimum alveolar concentration (MAC) for 20 min (after hour of glucose and before I/R) 26 volunteers were studied 67 times in this arm."
600031|NCT00995670|P3|Participant Flow|Statin and Glucose|Volunteers ingested a 40 mg simvastatin (statin) pill for the two evenings prior to study day and the morning of the study to determine the effect of simvastatin on modulating the I/R injury during hyperglycemia (high glucose). Volunteers were studied with statin alone and with statin and glucose.
600032|NCT00995670|P2|Participant Flow|Vitamin C and Glucose|To determine if vitamin C can restore the impairment of the endothelium (FBF) caused by the glucose (dextrose infusion). All subjects received glucose and I/R injury (ischemia), either with or without vitamin C. Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
600033|NCT00995670|P1|Participant Flow|Sevoflurane and Glucose|Endothelial function will be measured via forearm blood flow (FBF). Subjects may get I/R injury (ischemia) without glucose or sevoflurane (placebo trial); I/R with glucose only (glucose trial); I/R with sevoflurane only (sevoflurane trial); I/R with glucose and sevoflurane (combined trial). Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
600261|NCT00996307|B4|Baseline|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600036|NCT00995670|O1|Outcome|Sevoflurane and Glucose|To determine the effectiveness of anesthetic preconditioning (APC) via sevoflurane to attenuate the I/R injury during the normal glucose state and during hyperglycemia.
600037|NCT00995670|E3|Reported Event|Statins & Glucose|To determine the effect of simvastatin on modulating the I/R injury during the normal glucose state and during hyperglycemia.
600038|NCT00995670|E2|Reported Event|Vitamin C & Glucose|To determine if vitamin C can restore the impairment of the endothelium caused by the dextrose infusion.
600039|NCT00995670|E1|Reported Event|Sevoflurane & Glucose|To determine the effectiveness of anesthetic preconditioning (APC) via sevoflurane to attenuate the I/R injury during the normal glucose state and during hyperglycemia.
600040|NCT00995709|B4|Baseline|Total|Total of all reporting groups
600041|NCT00995709|B3|Baseline|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
600042|NCT00995709|B2|Baseline|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
600043|NCT00995709|B1|Baseline|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
600044|NCT00995709|P3|Participant Flow|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
600045|NCT00995709|P2|Participant Flow|AIN457C 300 mg Monthly Dosage Regimen|"AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
One patient in the AIN457 300 mg monthly group (PID 0161/00002) was randomized; however, this patient did not meet eligibility criteria and never received study medication"
600046|NCT00995709|P1|Participant Flow|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
600047|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
600048|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
600049|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
600050|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
600051|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
600052|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
600053|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
600054|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
600055|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
600056|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
600062|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
600063|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
600064|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
600065|NCT00995709|E3|Reported Event|Placebo|Placebo was administered in 2 s.c. injections
600066|NCT00995709|E2|Reported Event|AIN457 300mg Monthly|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
600067|NCT00995709|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
600068|NCT00995722|B3|Baseline|Total|Total of all reporting groups
600069|NCT00995722|B2|Baseline|Placebo|"Matched, inactive substance
Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600070|NCT00995722|B1|Baseline|Prednisone|"Corticosteroid
Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600071|NCT00995722|P2|Participant Flow|Placebo|"Matched, inactive substance
Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600072|NCT00995722|P1|Participant Flow|Prednisone|"Corticosteroid
Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600073|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance
Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600074|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid
Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600102|NCT00995865|B2|Baseline|Mid-Dose Group|Two groups of 24 subjects each were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for this (mid dose) group.
601752|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
600075|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance
Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600076|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid
Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600077|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance
Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600078|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid
Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600079|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance
Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600080|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid
Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600081|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance
Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600082|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid
Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600083|NCT00995722|E2|Reported Event|Placebo|"Matched, inactive substance
Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600084|NCT00995722|E1|Reported Event|Prednisone|"Corticosteroid
Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.
Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
600085|NCT00995761|B1|Baseline|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
600086|NCT00995761|P1|Participant Flow|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
600087|NCT00995761|O1|Outcome|Biweekly Schedule of Docetaxel and Cisplatin|we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC.
600088|NCT00995761|E1|Reported Event|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
600089|NCT00995774|B3|Baseline|Total|Total of all reporting groups
600090|NCT00995774|B2|Baseline|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
600091|NCT00995774|B1|Baseline|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
600092|NCT00995774|P2|Participant Flow|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
600093|NCT00995774|P1|Participant Flow|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
600094|NCT00995774|O2|Outcome|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
600095|NCT00995774|O1|Outcome|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
600096|NCT00995774|O2|Outcome|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
600097|NCT00995774|O1|Outcome|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
600098|NCT00995774|E2|Reported Event|Arm 2|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
600099|NCT00995774|E1|Reported Event|Arm 1|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
600100|NCT00995865|B4|Baseline|Total|Total of all reporting groups
600103|NCT00995865|B1|Baseline|High Dose Group|Two groups of 24 subjects each, (one arm called a high dose group, the other a Mid-Dose group) were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for the (mid dose).
600104|NCT00995865|P3|Participant Flow|Placebo|"NaCl Injectable 0.9%
Placebo: NaCl Injectable 0.9%"
600105|NCT00995865|P2|Participant Flow|Mid Dose|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
600106|NCT00995865|P1|Participant Flow|High Dose|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
600107|NCT00995865|O3|Outcome|Placebo Group|"Subjects were administered with NaCl Injectable 0.9%.
12 Subjects were examined in this group."
600108|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
600109|NCT00995865|O1|Outcome|High Dose Group|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.
24 Subjects were examined in this group."
600110|NCT00995865|O3|Outcome|Placebo Group|"NaCl Injectable 0.9%
Placebo: NaCl Injectable 0.9%"
600111|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
600112|NCT00995865|O1|Outcome|High Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
600113|NCT00995865|O3|Outcome|Placebo Group|"NaCl Injectable 0.9%
Placebo: NaCl Injectable 0.9%"
600114|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
600115|NCT00995865|O1|Outcome|High Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
600116|NCT00995865|O3|Outcome|Placebo Group|"Subjects were administered with NaCl Injectable 0.9%.
12 Subjects were examined in this group."
600117|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
600118|NCT00995865|O1|Outcome|High Dose Group|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.
24 Subjects were examined in this group."
600119|NCT00995865|E6|Reported Event|Placebo Second Injection|"NaCl Injectable 0.9%
Placebo: NaCl Injectable 0.9% Second injection."
600170|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
600171|NCT00995930|O1|Outcome|Placebo|SQ monthly
600120|NCT00995865|E5|Reported Event|Mid Dose Second Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.
Second injection."
600121|NCT00995865|E4|Reported Event|High Dose Second Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.
Second injection at an interval of 21 days"
600122|NCT00995865|E3|Reported Event|Placebo First Injection|"NaCl Injectable 0.9%
Placebo: NaCl Injectable 0.9% First injection."
600123|NCT00995865|E2|Reported Event|Mid Dose First Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.
First injection."
600124|NCT00995865|E1|Reported Event|High Dose First Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.
First injection."
600125|NCT00995904|B1|Baseline|All Patients|All patients that were enrolled in the study.
600126|NCT00995904|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
600127|NCT00995904|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
600128|NCT00995904|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
600129|NCT00995904|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
600130|NCT00995904|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
600131|NCT00995904|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
600132|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
600133|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
600134|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
600135|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
600136|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
600137|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
600138|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
600139|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
600140|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
600141|NCT00995904|E3|Reported Event|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
600142|NCT00995904|E2|Reported Event|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
600143|NCT00995904|E1|Reported Event|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
600144|NCT00995930|B3|Baseline|Total|Total of all reporting groups
600145|NCT00995930|B2|Baseline|ACZ885|150 mg SQ monthly
600146|NCT00995930|B1|Baseline|Placebo|SQ monthly
600147|NCT00995930|P2|Participant Flow|ACZ885|150 mg SQ monthly
600148|NCT00995930|P1|Participant Flow|Placebo|SQ monthly
600149|NCT00995930|O1|Outcome|ACZ885|150 mg SQ monthly
600150|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
600151|NCT00995930|O1|Outcome|Placebo|SQ monthly
600152|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
600153|NCT00995930|O1|Outcome|Placebo|SQ monthly
600154|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
600155|NCT00995930|O1|Outcome|Placebo|SQ monthly
600156|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
600157|NCT00995930|O1|Outcome|Placebo|SQ monthly
600158|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
600159|NCT00995930|O1|Outcome|Placebo|SQ monthly
600160|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
600161|NCT00995930|O1|Outcome|Placebo|SQ monthly
600162|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
600163|NCT00995930|O1|Outcome|Placebo|SQ monthly
600164|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
600165|NCT00995930|O1|Outcome|Placebo|SQ monthly
600166|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
600167|NCT00995930|O1|Outcome|Placebo|SQ monthly
600168|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
600169|NCT00995930|O1|Outcome|Placebo|SQ monthly
600176|NCT00996034|B1|Baseline|Healthy Smoker|"Healthy smokers with nicotine dependence
Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days
[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days
NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
600177|NCT00996034|P1|Participant Flow|Healthy Smoker|"Healthy smokers with nicotine dependence
Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days
[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days
NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
600178|NCT00996034|O1|Outcome|Healthy Smoker|"Healthy smokers with nicotine dependence
Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days
[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days
NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
600179|NCT00996034|E1|Reported Event|Healthy Smoker|"Healthy smokers with nicotine dependence
Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days
[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days
NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
600180|NCT00996125|B3|Baseline|Total|Total of all reporting groups
600181|NCT00996125|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600182|NCT00996125|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600183|NCT00996125|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600184|NCT00996125|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600185|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600186|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600187|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600188|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600189|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600190|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600191|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600192|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600193|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600194|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600195|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600196|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600197|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600198|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600199|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600200|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600201|NCT00996125|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600202|NCT00996125|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
600203|NCT00996164|B3|Baseline|Total|Total of all reporting groups
600204|NCT00996164|B2|Baseline|Placebo|placebo 1 tab po qd
600205|NCT00996164|B1|Baseline|Flibanserin 100 mg|flibanserin 100mg po qd
600206|NCT00996164|P2|Participant Flow|Placebo|placebo 1 tab po qd
600207|NCT00996164|P1|Participant Flow|Flibanserin 100 mg|flibanserin 100mg po qd
600208|NCT00996164|O2|Outcome|Placebo|"placebo 1 tab po qd
Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
600287|NCT00996307|O2|Outcome|7.5_(0)MF59 - HI <1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600209|NCT00996164|O1|Outcome|Flibanserin 100 mg|"flibanserin 100mg po qd
Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
600210|NCT00996164|O2|Outcome|Placebo|"placebo 1 tab po qd
Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
600211|NCT00996164|O1|Outcome|Flibanserin 100 mg|"flibanserin 100mg po qd
Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
600212|NCT00996164|E2|Reported Event|Placebo|placebo 1 tab po qd
600213|NCT00996164|E1|Reported Event|Flibanserin 100 mg|flibanserin 100mg po qd
600214|NCT00996203|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600215|NCT00996203|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (but not more than 800 mg), intravenously (IV), every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600216|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600217|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600218|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600219|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600220|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600221|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600222|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600223|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600224|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600225|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600226|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600227|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600228|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
601231|NCT00998023|O2|Outcome|AngioSeal VCD|AngioSeal Vascular Closure Device
600229|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600230|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600231|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600232|NCT00996203|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
600233|NCT00996216|B1|Baseline|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600234|NCT00996216|P1|Participant Flow|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600252|NCT00996281|P2|Participant Flow|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
601704|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
600235|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600236|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600237|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600258|NCT00996281|E2|Reported Event|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
600262|NCT00996307|B3|Baseline|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600238|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600239|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600240|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600241|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600253|NCT00996281|P1|Participant Flow|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
600288|NCT00996307|O1|Outcome|3.75_(50)MF59- Baseline HI <1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600242|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600243|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600244|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600245|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600246|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600247|NCT00996216|E2|Reported Event|Eltrombopag (Part 2)|Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
600248|NCT00996216|E1|Reported Event|Eltrombopag (Part 1)|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study.
600249|NCT00996281|B3|Baseline|Total|Total of all reporting groups
600250|NCT00996281|B2|Baseline|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
600251|NCT00996281|B1|Baseline|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
600286|NCT00996307|O3|Outcome|7.5_(50)MF59 - HI <1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
618994|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
600254|NCT00996281|O2|Outcome|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
600255|NCT00996281|O1|Outcome|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
600256|NCT00996281|O2|Outcome|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
600257|NCT00996281|O1|Outcome|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
600259|NCT00996281|E1|Reported Event|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
600260|NCT00996307|B5|Baseline|Total|Total of all reporting groups
600263|NCT00996307|B2|Baseline|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600264|NCT00996307|B1|Baseline|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600265|NCT00996307|P4|Participant Flow|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600266|NCT00996307|P3|Participant Flow|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600267|NCT00996307|P2|Participant Flow|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600268|NCT00996307|P1|Participant Flow|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600269|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600270|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600271|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600272|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600273|NCT00996307|O8|Outcome|15_(0)MF59 - Baseline HI ≥1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600274|NCT00996307|O7|Outcome|7.5_(50)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600275|NCT00996307|O6|Outcome|7.5_(0)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600276|NCT00996307|O5|Outcome|3.75_(50)MF59 - Baseline HI ≥1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600277|NCT00996307|O4|Outcome|15_(0)MF59 - HI <1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600278|NCT00996307|O3|Outcome|7.5_(50)MF59 - HI <1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600279|NCT00996307|O2|Outcome|7.5_(0)MF59 - HI <1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600280|NCT00996307|O1|Outcome|3.75_(50)MF59- Baseline HI <1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600281|NCT00996307|O8|Outcome|15_(0)MF59 - Baseline HI ≥1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600282|NCT00996307|O7|Outcome|7.5_(50)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600283|NCT00996307|O6|Outcome|7.5_(0)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600284|NCT00996307|O5|Outcome|3.75_(50)MF59 - Baseline HI ≥1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600285|NCT00996307|O4|Outcome|15_(0)MF59 - HI <1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600289|NCT00996307|O8|Outcome|15_(0)MF59-with Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600290|NCT00996307|O7|Outcome|7.5_(50) MF59-Previous Vaccinaiton|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600291|NCT00996307|O6|Outcome|7.5_(0)MF59-Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600292|NCT00996307|O5|Outcome|3.75_(50)MF59-Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600293|NCT00996307|O4|Outcome|15_(0)MF59 - No Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600294|NCT00996307|O3|Outcome|7.5_(50)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600295|NCT00996307|O2|Outcome|7.5_(0)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600296|NCT00996307|O1|Outcome|3.75_(50)MF59- No Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600297|NCT00996307|O8|Outcome|15_(0)MF59-Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600298|NCT00996307|O7|Outcome|7.5_(50) MF59-Previous Vaccinaiton|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600299|NCT00996307|O6|Outcome|7.5_(0)MF59-Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600300|NCT00996307|O5|Outcome|3.75_(50)MF59-Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600301|NCT00996307|O4|Outcome|15_(0)MF59 - No Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600302|NCT00996307|O3|Outcome|7.5_(50)MF59-No Previous Vaccination|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600303|NCT00996307|O2|Outcome|7.5_(0)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600304|NCT00996307|O1|Outcome|3.75_(50)MF59- No Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600305|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600306|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600307|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600308|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600309|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600310|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600311|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600312|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600313|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600314|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600315|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600316|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600317|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600318|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600319|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600320|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600321|NCT00996307|E4|Reported Event|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600322|NCT00996307|E3|Reported Event|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600323|NCT00996307|E2|Reported Event|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
600324|NCT00996307|E1|Reported Event|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
600325|NCT00996333|B1|Baseline|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days
Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11
This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
600326|NCT00996333|P1|Participant Flow|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days
Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11
This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
600327|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days
Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11
This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
600328|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days
Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11
This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
600363|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
600329|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days
Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11
This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
600330|NCT00996333|E1|Reported Event|Gemzar, Taxotere, Xeloda|"Gemcitabine, Docetaxel, Capecitabine:
Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days
Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11
This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
600331|NCT00996346|B4|Baseline|Total|Total of all reporting groups
600332|NCT00996346|B3|Baseline|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
600333|NCT00996346|B2|Baseline|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
One cycle is four weeks."
600334|NCT00996346|B1|Baseline|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
One cycle is four weeks."
600335|NCT00996346|P3|Participant Flow|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
600336|NCT00996346|P2|Participant Flow|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
One cycle is four weeks."
600337|NCT00996346|P1|Participant Flow|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
One cycle is four weeks."
600338|NCT00996346|O1|Outcome|Irinotecan&Temsirolimus:All Arms|"Data from the dose escalation in all three arms is used to calculate the maximum tolerated dose (MTD).
In all three arms, Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest. One course will be four weeks.
The treatment consists of:
Irinotecan at 50 - 80 mg/m2 weekly, for three weeks + Temsirolimus at 15 - 25 mg weekly, for three weeks.
The specific doses of Irinotecan are 50, 65, or 80 mg/m2 The specific doses of Temsirolimus are 15, 20, or 25 mg"
600339|NCT00996346|O1|Outcome|Irinotecan&Temsirolimus:All Arms|"Data from the dose escalation in all three arms is used to calculate the maximum tolerated dose (MTD).
In all three arms, Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest. One course will be four weeks.
The treatment consists of:
Irinotecan at 50 - 80 mg/m2 weekly, for three weeks + Temsirolimus at 15 - 25 mg weekly, for three weeks.
The specific doses of Irinotecan are 50, 65, or 80 mg/m2 The specific doses of Temsirolimus are 15, 20, or 25 mg"
600340|NCT00996346|E3|Reported Event|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
600341|NCT00996346|E2|Reported Event|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
One cycle is four weeks."
600342|NCT00996346|E1|Reported Event|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
One cycle is four weeks."
600343|NCT00996372|B3|Baseline|Total|Total of all reporting groups
600344|NCT00996372|B2|Baseline|Placebo|
600345|NCT00996372|B1|Baseline|Flibanserin|
600346|NCT00996372|P2|Participant Flow|Placebo|"placebo one tablet po qd
placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
600347|NCT00996372|P1|Participant Flow|Flibanserin 100mg|"flibanserin 100mg po qd
flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
600348|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd
placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
600349|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd
flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
600350|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd
placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
600351|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd
flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
600352|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd
placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
600353|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd
flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
600354|NCT00996372|E2|Reported Event|Placebo|"placebo one tablet po qd
placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
600355|NCT00996372|E1|Reported Event|Flibanserin 100mg|"flibanserin 100mg po qd
flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
600356|NCT00996437|B3|Baseline|Total|Total of all reporting groups
600357|NCT00996437|B2|Baseline|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
600358|NCT00996437|B1|Baseline|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
600359|NCT00996437|P2|Participant Flow|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
600360|NCT00996437|P1|Participant Flow|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
600361|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
600362|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
600364|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
600365|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
600366|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
600367|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
600368|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
600369|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
600370|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
600371|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
600372|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
600373|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
600374|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
600375|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
600376|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
600377|NCT00996437|E2|Reported Event|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
600378|NCT00996437|E1|Reported Event|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
600379|NCT00996476|B6|Baseline|Total|Total of all reporting groups
600380|NCT00996476|B5|Baseline|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600381|NCT00996476|B4|Baseline|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600382|NCT00996476|B3|Baseline|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600383|NCT00996476|B2|Baseline|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600405|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600823|NCT00996632|O1|Outcome|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
600384|NCT00996476|B1|Baseline|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600385|NCT00996476|P5|Participant Flow|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600386|NCT00996476|P4|Participant Flow|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600387|NCT00996476|P3|Participant Flow|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600388|NCT00996476|P2|Participant Flow|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600389|NCT00996476|P1|Participant Flow|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600390|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600391|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600392|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600506|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600507|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
618995|NCT01037244|O4|Outcome|Placebo|Placebo tablets
600393|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600394|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600395|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
600396|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
600397|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
600398|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
600399|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
600400|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
600401|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600402|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600403|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600404|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600824|NCT00996632|E2|Reported Event|Conventional|Patients were operated by a conventional diatherm knife
600406|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600407|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600408|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600409|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600410|NCT00996476|O6|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600411|NCT00996476|O5|Outcome|All TMC435|TMC435 50 mg or 100 mg capsule orally once daily for 12 or 24 weeks
600412|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600413|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600414|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600508|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600509|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
601705|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
600415|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600416|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600417|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600418|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600419|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600420|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600421|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600422|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600423|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600477|NCT00985712|P1|Participant Flow|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
600478|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
600424|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600425|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600426|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600427|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600428|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600429|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600430|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600431|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600432|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600433|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600510|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600511|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
600434|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600435|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600436|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600437|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600438|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600439|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600440|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600441|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600442|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600443|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600444|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600445|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600446|NCT00996476|O3|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600447|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
600448|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
600449|NCT00996476|E5|Reported Event|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
600450|NCT00996476|E4|Reported Event|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600451|NCT00996476|E3|Reported Event|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
600452|NCT00996476|E2|Reported Event|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600453|NCT00996476|E1|Reported Event|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
600512|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600513|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
601706|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
600454|NCT00996502|B1|Baseline|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)
Phase I:
Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Docetaxel: Phase I:
Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle
Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle
Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle
Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks
Erlotinib: 200 mg of Erlotinib PO daily days 2-16
Prednisone: 5 mg of Prednisone PO bid"
600455|NCT00996502|P1|Participant Flow|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)
Phase I:
Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Docetaxel: Phase I:
Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle
Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle
Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle
Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks
Erlotinib: 200 mg of Erlotinib PO daily days 2-16
Prednisone: 5 mg of Prednisone PO bid"
600456|NCT00996502|O1|Outcome|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)
Phase I:
Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Docetaxel: Phase I:
Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle
Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle
Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle
Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks
Erlotinib: 200 mg of Erlotinib PO daily days 2-16
Prednisone: 5 mg of Prednisone PO bid"
600479|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
600480|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
600481|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
600672|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
600457|NCT00996502|E1|Reported Event|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)
Phase I:
Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Docetaxel: Phase I:
Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle
Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle
Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle
Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks
Erlotinib: 200 mg of Erlotinib PO daily days 2-16
Prednisone: 5 mg of Prednisone PO bid"
600458|NCT00985686|B5|Baseline|Total|Total of all reporting groups
600459|NCT00985686|B4|Baseline|Waitlist Arm, Older Subgroup|Subgroup of participants 19-24 years of age randomized into the waitlist arm.
600460|NCT00985686|B3|Baseline|Waitlist Arm, Younger Subgroup|Subgroup of participants 13-18 years of age randomized into the waitlist arm.
600461|NCT00985686|B2|Baseline|Study Arm, Older Subgroup|Subgroup of participants 19-24 years of age randomized into the study arm.
600462|NCT00985686|B1|Baseline|Study Arm, Younger Subgroup|Subgroup of participants 13-18 years of age randomized into the study arm.
600463|NCT00985686|P4|Participant Flow|Waitlist Arm, Older Subgroup|"Arm where older participants (19 to 24 years of age) received the LEAP Project intervention after an 8 week wait period.
At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
600464|NCT00985686|P3|Participant Flow|Waitlist Arm, Younger Subgroup|"Arm where younger participants (13-18 years of age) received the LEAP Project intervention after an 8 week wait period.
At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
600465|NCT00985686|P2|Participant Flow|Study Arm, Older Subgroup|"Arm where older participants (19 to 24 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
600514|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600515|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
601707|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
600466|NCT00985686|P1|Participant Flow|Study Arm, Younger Subgroup|"Arm where younger participants (13 to 18 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
600467|NCT00985686|O1|Outcome|Older Subgroup (19-24 Years of Age)|Subgroup of participants 19-24 years of age. Participants were randomized into the Study and Waitlist Arms.
600468|NCT00985686|O1|Outcome|Younger Subgroup (13-18 Years of Age)|Subgroup of participants 13-18 years of age. Participants were randomized into the Study and Waitlist Arms.
600469|NCT00985686|E4|Reported Event|Waitlist Arm, Older Subgroup|Participants 19-24 years of age randomized into the wait list group
600470|NCT00985686|E3|Reported Event|Waitlist Arm, Younger Subgroup|Participants 13-18 years of age randomized into the waitlist group
600471|NCT00985686|E2|Reported Event|Study Arm, Older Subgroup|Participants 19-24 years of age randomized into the study group
600472|NCT00985686|E1|Reported Event|Study Arm, Younger Subgroup|Participants 13-18 years of age randomized into the study group
600473|NCT00985712|B3|Baseline|Total|Total of all reporting groups
600474|NCT00985712|B2|Baseline|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
600475|NCT00985712|B1|Baseline|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
600476|NCT00985712|P2|Participant Flow|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
600825|NCT00996632|E1|Reported Event|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
600482|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
600483|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
600484|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
600485|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
600486|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
600487|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
600488|NCT00985712|E2|Reported Event|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
600489|NCT00985712|E1|Reported Event|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
600490|NCT00985725|B3|Baseline|Total|Total of all reporting groups
600491|NCT00985725|B2|Baseline|Placebo|Administered orally once-daily for 9 weeks.
600492|NCT00985725|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600493|NCT00985725|P2|Participant Flow|Placebo|Administered orally once-daily for 9 weeks.
600494|NCT00985725|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600495|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
600496|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600497|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
600498|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600499|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
600500|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600501|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
600502|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600503|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
600504|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600505|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
600516|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600517|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
600518|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600519|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
600520|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600521|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
600522|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600523|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
600524|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600525|NCT00985725|E2|Reported Event|Placebo|Administered orally once-daily for 9 weeks.
600526|NCT00985725|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
600527|NCT00985738|B3|Baseline|Total|Total of all reporting groups
600528|NCT00985738|B2|Baseline|Placebo|This group received a placebo followed by 3D mapping biopsy.
600529|NCT00985738|B1|Baseline|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
600530|NCT00985738|P2|Participant Flow|Placebo|This group received a placebo followed by 3D mapping biopsy.
600531|NCT00985738|P1|Participant Flow|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
600532|NCT00985738|O2|Outcome|Placebo|This group received a placebo followed by 3D mapping biopsy.
600533|NCT00985738|O1|Outcome|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
600534|NCT00985738|E2|Reported Event|Placebo|This group received a placebo followed by 3D mapping biopsy.
600535|NCT00985738|E1|Reported Event|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
600536|NCT00985790|B3|Baseline|Total|Total of all reporting groups
600609|NCT00985959|O4|Outcome|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
600537|NCT00985790|B2|Baseline|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600538|NCT00985790|B1|Baseline|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600539|NCT00985790|P2|Participant Flow|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600540|NCT00985790|P1|Participant Flow|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600541|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600542|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600543|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600544|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600545|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600546|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600547|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600548|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600826|NCT00996658|B3|Baseline|Total|Total of all reporting groups
600827|NCT00996658|B2|Baseline|Linagliptin 5 mg Tablet|
600549|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600550|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600551|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600552|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600553|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600554|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600555|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600556|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600557|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600558|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600559|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600560|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600561|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600562|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600563|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600564|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600565|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600638|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
600566|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600567|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600568|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600569|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600570|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600571|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600572|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600573|NCT00985790|E2|Reported Event|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
600574|NCT00985790|E1|Reported Event|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
600575|NCT00985829|B1|Baseline|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
600576|NCT00985829|P1|Participant Flow|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
600577|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
600578|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
600579|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
600580|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
600581|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
600582|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
600583|NCT00985829|E1|Reported Event|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
600584|NCT00985946|B1|Baseline|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
600585|NCT00985946|P1|Participant Flow|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
600610|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600828|NCT00996658|B1|Baseline|Placebo Tablet|
600586|NCT00985946|O1|Outcome|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
600587|NCT00985946|O1|Outcome|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
600588|NCT00985946|O1|Outcome|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
600589|NCT00985946|O1|Outcome|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
600590|NCT00985946|O1|Outcome|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
600591|NCT00985946|E1|Reported Event|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design. Fifteen patients were accrued, and 13 were evaluable for response. No responses were seen, but the stable disease rate was 100%. The median progression-free survival (PFS) was 9.9 months, and the median overall survival was 47.3 months. Fatigue (27%), thrombocytopenia (20%), diarrhea (13%), and nausea (13%) were the most common related grade 3 toxicities. There was one grade 4 thrombocytopenia (7%). These results did not meet the prespecified criteria to open the study to full accrual.
600592|NCT00985959|B4|Baseline|Total|Total of all reporting groups
600593|NCT00985959|B3|Baseline|Phase I and II - JNJ-26866138 1.3 mg/m2 Group|Phase I: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
600594|NCT00985959|B2|Baseline|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600595|NCT00985959|B1|Baseline|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600596|NCT00985959|P3|Participant Flow|Phase I and II - JNJ-26866138 1.3 mg/m2 Group|Phase I: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
600597|NCT00985959|P2|Participant Flow|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600598|NCT00985959|P1|Participant Flow|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600599|NCT00985959|O1|Outcome|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
600600|NCT00985959|O1|Outcome|Prednisolone|Prednisolone 60 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
600601|NCT00985959|O1|Outcome|Melphalan|Melphalan 9 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
600602|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600603|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600604|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600605|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600606|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600607|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600608|NCT00985959|O5|Outcome|Total|Participants from both Phase I and Phase II
600611|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600612|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600613|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600614|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600615|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600616|NCT00985959|E4|Reported Event|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
600617|NCT00985959|E3|Reported Event|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600618|NCT00985959|E2|Reported Event|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600619|NCT00985959|E1|Reported Event|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
600620|NCT00985985|B5|Baseline|Total|Total of all reporting groups
600621|NCT00985985|B4|Baseline|Placebo Lozenge (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
600622|NCT00985985|B3|Baseline|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally.
600623|NCT00985985|B2|Baseline|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally.
600624|NCT00985985|B1|Baseline|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally.
600625|NCT00985985|P4|Participant Flow|Placebo Lozenge (High Dependence Smoke|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
600626|NCT00985985|P3|Participant Flow|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
600627|NCT00985985|P2|Participant Flow|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take atleast 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse
600628|NCT00985985|P1|Participant Flow|Nicotine Lozenge 2 Milligram (mg) (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally. During week 1 to week 6,participants were recommended to take at least 9 lozenges per day, but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
600629|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
600630|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally.
600631|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine, orally.
600632|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge, orally.
600633|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
600634|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
600635|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
600636|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge, orally.
600637|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
601232|NCT00998023|O1|Outcome|Mynx VCD|Mynx Vascular Closure Device
600639|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
600640|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
600641|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine, orally.
600642|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
600643|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
600644|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
600645|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
600646|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
600647|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
600648|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
600649|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
600650|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
600651|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
600652|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
600653|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
600654|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
600655|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
600656|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
600657|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
600658|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
600659|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
600660|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
600661|NCT00985985|E4|Reported Event|Placebo Lozenge (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
600662|NCT00985985|E3|Reported Event|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg of nicotine lozenge, orally.
600663|NCT00985985|E2|Reported Event|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
600664|NCT00985985|E1|Reported Event|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes after waking received 2 mg of nicotine lozenge, orally.
600665|NCT00996580|B1|Baseline|DR-103|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600666|NCT00996580|P1|Participant Flow|DR-103|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600667|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
600668|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
600669|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600670|NCT00996580|O1|Outcome|DR-103|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600671|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
600673|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600674|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
600675|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
600676|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600677|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
600678|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
600679|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600680|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
600681|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
600682|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600683|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
600684|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
600685|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600686|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
600687|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
600688|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600689|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
600690|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
600863|NCT00996736|O1|Outcome|Topical Natamycin|
600864|NCT00996736|O2|Outcome|Topical Voriconazole|
600691|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600692|NCT00996580|E1|Reported Event|DR-103|"Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
7 days of 10 mcg EE."
600693|NCT00996593|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600694|NCT00996593|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600695|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600734|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600829|NCT00996658|P2|Participant Flow|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600696|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600697|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600698|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600699|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600700|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600701|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600865|NCT00996736|O1|Outcome|Topical Natamycin|
600702|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600703|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600704|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600705|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600706|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600707|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600708|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600709|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600710|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600711|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600866|NCT00996736|O2|Outcome|Topical Voriconazole|
600712|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600713|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600714|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600715|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600716|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600717|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600718|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600719|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600720|NCT00996593|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
600721|NCT00996606|B1|Baseline|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600722|NCT00996606|P1|Participant Flow|Tocilizumab in Active Rheumatoid Arthritis (RA)|Participants with active RA received tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600867|NCT00996736|O1|Outcome|Topical Natamycin|
600868|NCT00996736|O2|Outcome|Topical Voriconazole|
600869|NCT00996736|O1|Outcome|Topical Natamycin|
600723|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600724|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600725|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600726|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600727|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600728|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600729|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600730|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600731|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600732|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600733|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600830|NCT00996658|P1|Participant Flow|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600735|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600736|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600737|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600738|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600739|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600740|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600741|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600742|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600743|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600744|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600745|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600746|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600747|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600748|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600749|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600750|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600870|NCT00996736|O2|Outcome|Topical Voriconazole|
600871|NCT00996736|O1|Outcome|Topical Natamycin|
600751|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600752|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600753|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600754|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600755|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600756|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600757|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600758|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600759|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600760|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600761|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600762|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600763|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600764|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600765|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600766|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600767|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600768|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600769|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600770|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600771|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600772|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600773|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600774|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600775|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600776|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600777|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600778|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600872|NCT00996736|O2|Outcome|Topical Voriconazole|
600873|NCT00996736|O1|Outcome|Topical Natamycin|
600779|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600780|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600781|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600782|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600783|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600784|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600785|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600786|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600787|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600788|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600789|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600790|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600791|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600792|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600793|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600794|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600795|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600796|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600797|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600798|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600799|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600800|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600801|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600802|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600803|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600804|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600805|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600806|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600874|NCT00996736|E2|Reported Event|Topical Voriconazole|
600875|NCT00996736|E1|Reported Event|Topical Natamycin|
600807|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600808|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600809|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600810|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600811|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600812|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600813|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600814|NCT00996606|E1|Reported Event|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
600815|NCT00996632|B3|Baseline|Total|Total of all reporting groups
600816|NCT00996632|B2|Baseline|Conventional|Patients were operated by a conventional diatherm knife
600817|NCT00996632|B1|Baseline|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
600818|NCT00996632|P2|Participant Flow|Conventional|Patients were operated by a conventional diatherm knife
600819|NCT00996632|P1|Participant Flow|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
600820|NCT00996632|O2|Outcome|Conventional|Patients were operated by a conventional diatherm knife
600821|NCT00996632|O1|Outcome|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
600822|NCT00996632|O2|Outcome|Conventional|Patients were operated by a conventional diatherm knife
601753|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
600831|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600832|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600833|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600834|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600835|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600836|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600837|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600838|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600839|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600840|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600841|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600842|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600843|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600844|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600845|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600846|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600847|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600848|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600849|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600850|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600851|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600852|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600853|NCT00996658|E2|Reported Event|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
600854|NCT00996658|E1|Reported Event|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
600855|NCT00996736|B3|Baseline|Total|Total of all reporting groups
600856|NCT00996736|B2|Baseline|Topical Voriconazole|
600857|NCT00996736|B1|Baseline|Topical Natamycin|
600858|NCT00996736|P2|Participant Flow|Topical Voriconazole|
600859|NCT00996736|P1|Participant Flow|Topical Natamycin|
600860|NCT00996736|O2|Outcome|Topical Voriconazole|
600861|NCT00996736|O1|Outcome|Topical Natamycin|
600862|NCT00996736|O2|Outcome|Topical Voriconazole|
600877|NCT00996775|B2|Baseline|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention
brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.
Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
600878|NCT00996775|B1|Baseline|Arm 1|"Group receiving treatment-as-usual.
Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
600879|NCT00996775|P2|Participant Flow|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention
brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.
Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
600880|NCT00996775|P1|Participant Flow|Arm 1|"Group receiving treatment-as-usual.
Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
600881|NCT00996775|O2|Outcome|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention
brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.
Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
600882|NCT00996775|O1|Outcome|Arm 1|"Group receiving treatment-as-usual.
Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
600883|NCT00996775|E2|Reported Event|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention
brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.
Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
600884|NCT00996775|E1|Reported Event|Arm 1|"Group receiving treatment-as-usual.
Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
600885|NCT00996801|B7|Baseline|Total|Total of all reporting groups
600886|NCT00996801|B6|Baseline|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600887|NCT00996801|B5|Baseline|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600888|NCT00996801|B4|Baseline|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600889|NCT00996801|B3|Baseline|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600890|NCT00996801|B2|Baseline|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600891|NCT00996801|B1|Baseline|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600892|NCT00996801|P6|Participant Flow|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600893|NCT00996801|P5|Participant Flow|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600894|NCT00996801|P4|Participant Flow|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600895|NCT00996801|P3|Participant Flow|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600896|NCT00996801|P2|Participant Flow|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600897|NCT00996801|P1|Participant Flow|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600898|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600899|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
600900|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600901|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600902|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600903|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600904|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600905|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
600906|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600907|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600908|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600909|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600910|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600911|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.
The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
600912|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600913|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600914|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600915|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600916|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600917|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600918|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600919|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600920|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600921|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600922|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
601035|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
600923|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600924|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600925|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600926|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600927|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600928|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600929|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600930|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600931|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600932|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600933|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600934|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600935|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600936|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600937|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600938|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600939|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600940|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600941|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
618996|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
600942|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600943|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600944|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600945|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600946|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600947|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600948|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600949|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600950|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600951|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600952|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600953|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600954|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600955|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600956|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600957|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600958|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600959|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600960|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600961|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600962|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600963|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600964|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600965|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600966|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600967|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600968|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600969|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600970|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600971|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600972|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600973|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600974|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600975|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600976|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600977|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600978|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600979|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
601708|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
600980|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600981|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600982|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600983|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600984|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600985|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600986|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
600987|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
600988|NCT00996801|O3|Outcome|MK-5442 7.5mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
600989|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
600990|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
600991|NCT00996801|E6|Reported Event|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600992|NCT00996801|E5|Reported Event|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600993|NCT00996801|E4|Reported Event|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600994|NCT00996801|E3|Reported Event|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600995|NCT00996801|E2|Reported Event|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
601226|NCT00998023|B3|Baseline|Total|Total of all reporting groups
600996|NCT00996801|E1|Reported Event|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
600997|NCT00997425|B1|Baseline|Arm 1 Door Cover; Floor Cover|"Floor cover - a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door. Door cover - a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape"
600998|NCT00997425|P1|Participant Flow|Arm 1 Door Cover; Floor Cover|The interventions were provided in the order door cover, then floor cover and then floor cover followed by door cover. After a baseline of 14 days the first Intervention (14 days) was provided, followed by baseline two for another 14 days followed by a second Intervention (14 days).
600999|NCT00997425|O2|Outcome|Floor Cover|"a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door.-"
601000|NCT00997425|O1|Outcome|Door Cover|- a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape
601001|NCT00997425|E1|Reported Event|Arm 1 Door Cover; Floor Cover|"Floor cover - a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door. Door cover - a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape"
601002|NCT00997438|B4|Baseline|Total|Total of all reporting groups
601003|NCT00997438|B3|Baseline|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601004|NCT00997438|B2|Baseline|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601005|NCT00997438|B1|Baseline|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601006|NCT00997438|P3|Participant Flow|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601007|NCT00997438|P2|Participant Flow|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601008|NCT00997438|P1|Participant Flow|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601009|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601010|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601011|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601012|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601013|NCT00997438|O2|Outcome|MS - Relapsing Remitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601014|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601015|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601016|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601017|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601018|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601019|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601020|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601021|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601022|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601023|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601024|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601025|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601026|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601027|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601028|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601029|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601030|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601031|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601032|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601033|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601034|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601036|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601037|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601038|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601039|NCT00997438|E3|Reported Event|Healthy Controls|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601040|NCT00997438|E2|Reported Event|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601041|NCT00997438|E1|Reported Event|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
601042|NCT00997503|B1|Baseline|TAXUS Liberté Post-Approval Study Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601043|NCT00997503|P1|Participant Flow|TAXUS Libertē: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601044|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601045|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601046|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601047|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601048|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601049|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601050|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601491|NCT00998660|B1|Baseline|Dystonia Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat dystonia.
601051|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601052|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601053|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601054|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601055|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601056|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601057|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601058|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601059|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601060|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601061|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601062|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601063|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601064|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601065|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601066|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601067|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601068|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601069|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601070|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601071|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601072|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601073|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601074|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601075|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601076|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601679|NCT00999141|O4|Outcome|Moderately Satisfied|
601680|NCT00999141|O3|Outcome|Somewhat Satisfied|
601077|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601078|NCT00997503|O1|Outcome|Medically Treated Diabetic Population|Patients enrolled in the TAXUS Libertē Post-Approval Study with medically treated diabetes.
601079|NCT00997503|O1|Outcome|TAXUS Libertē: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601080|NCT00997503|O1|Outcome|TAXUS Libertē Post-Approval Study Enrolled Population|There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
601081|NCT00997503|E1|Reported Event|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
601082|NCT00997516|B3|Baseline|Total|Total of all reporting groups
601083|NCT00997516|B2|Baseline|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601084|NCT00997516|B1|Baseline|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601085|NCT00997516|P2|Participant Flow|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601086|NCT00997516|P1|Participant Flow|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601087|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601088|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601089|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601090|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601091|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601092|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601093|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601094|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601095|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601096|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601227|NCT00998023|B2|Baseline|AngioSeal VCD|AngioSeal Vascular Closure Device
601097|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601098|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601099|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601100|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601101|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601102|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601103|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601104|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601105|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601106|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601107|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601108|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601109|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601110|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601111|NCT00997516|E2|Reported Event|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
601112|NCT00997516|E1|Reported Event|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
601113|NCT00997555|B3|Baseline|Total|Total of all reporting groups
601114|NCT00997555|B2|Baseline|Control Group|Standard treatment without scheduled bronchoscopy.
601115|NCT00997555|B1|Baseline|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
601116|NCT00997555|P2|Participant Flow|Control Group|Standard treatment without scheduled bronchoscopy.
601117|NCT00997555|P1|Participant Flow|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
601118|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
601119|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
601120|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
601121|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
601122|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
601123|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
601124|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
601125|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
601126|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
601127|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
601128|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
601129|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
601130|NCT00997555|E2|Reported Event|Control Group|Standard treatment without scheduled bronchoscopy.
601131|NCT00997555|E1|Reported Event|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
601132|NCT00997594|B3|Baseline|Total|Total of all reporting groups
601133|NCT00997594|B2|Baseline|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
601134|NCT00997594|B1|Baseline|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
601135|NCT00997594|P2|Participant Flow|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
601136|NCT00997594|P1|Participant Flow|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
601137|NCT00997594|O2|Outcome|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
601138|NCT00997594|O1|Outcome|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
601139|NCT00997594|E2|Reported Event|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
601140|NCT00997594|E1|Reported Event|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
601141|NCT00997672|B3|Baseline|Total|Total of all reporting groups
601142|NCT00997672|B2|Baseline|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
601143|NCT00997672|B1|Baseline|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
601144|NCT00997672|P2|Participant Flow|Placebo|Placebo
601145|NCT00997672|P1|Participant Flow|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
601146|NCT00997672|O2|Outcome|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
601147|NCT00997672|O1|Outcome|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
601148|NCT00997672|E2|Reported Event|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
601149|NCT00997672|E1|Reported Event|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
601150|NCT00997932|B1|Baseline|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.
Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
601151|NCT00997932|P1|Participant Flow|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.
Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
601152|NCT00997932|O1|Outcome|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.
Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
601153|NCT00997932|E2|Reported Event|No IUD Insertion|Women in this group underwent baseline data collection, stated they would like to enroll and receive an IUD between 10 minutes and 48 hours postpartum. These women were not eligible to receive the IUD due to delivery elsewhere, medical complications in peri-partum period.
601154|NCT00997932|E1|Reported Event|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.
Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
601155|NCT00997984|B4|Baseline|Total|Total of all reporting groups
601156|NCT00997984|B3|Baseline|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601681|NCT00999141|O2|Outcome|A Little Satisfied|
601157|NCT00997984|B2|Baseline|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601158|NCT00997984|B1|Baseline|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601159|NCT00997984|P3|Participant Flow|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601160|NCT00997984|P2|Participant Flow|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601161|NCT00997984|P1|Participant Flow|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601162|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601163|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601164|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601165|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601166|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601167|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601168|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601169|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601170|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601171|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601172|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601173|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601174|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601175|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601176|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601177|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601178|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601179|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601180|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601181|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601182|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601183|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601184|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601185|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601186|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601187|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601188|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601189|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601190|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601191|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601192|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601193|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601194|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601195|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601196|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601197|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601198|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601199|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601200|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601201|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601202|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601203|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601682|NCT00999141|O1|Outcome|Not at All Satisfied|
601204|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601205|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601206|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601207|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601208|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601209|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601210|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601211|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601212|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601213|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601214|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601215|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601216|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601217|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601218|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
601219|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601220|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601221|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601222|NCT00997984|E4|Reported Event|All Active|The combined results of the SPD503 AM and PM groups
601223|NCT00997984|E3|Reported Event|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
601224|NCT00997984|E2|Reported Event|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
601225|NCT00997984|E1|Reported Event|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
601233|NCT00998023|O2|Outcome|AngioSeal VCD|AngioSeal Vascular Closure Device
601234|NCT00998023|O1|Outcome|Mynx VCD|Mynx Vascular Closure Device
601235|NCT00998023|E2|Reported Event|AngioSeal VCD|AngioSeal Vascular Closure Device
601236|NCT00998023|E1|Reported Event|Mynx VCD|Mynx Vascular Closure Device
601237|NCT00998049|B1|Baseline|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
601238|NCT00998049|P1|Participant Flow|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
601239|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
601240|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
601241|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
601242|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
601243|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
601244|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
601245|NCT00998049|E1|Reported Event|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
601246|NCT00998205|B1|Baseline|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
601247|NCT00998205|P1|Participant Flow|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
601267|NCT00998296|P7|Participant Flow|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601248|NCT00998205|O1|Outcome|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
601249|NCT00998205|O1|Outcome|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion would be undertaken starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
601250|NCT00998205|E1|Reported Event|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion would be undertaken starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
601251|NCT00998296|B12|Baseline|Total|Total of all reporting groups
601252|NCT00998296|B11|Baseline|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the expansion phase which follows on the dose-escalation phase."
601253|NCT00998296|B10|Baseline|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the expansion phase which follows on the dose-escalation phase."
601254|NCT00998296|B9|Baseline|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601255|NCT00998296|B8|Baseline|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601256|NCT00998296|B7|Baseline|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601257|NCT00998296|B6|Baseline|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601464|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
601258|NCT00998296|B5|Baseline|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601259|NCT00998296|B4|Baseline|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601260|NCT00998296|B3|Baseline|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601261|NCT00998296|B2|Baseline|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601262|NCT00998296|B1|Baseline|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601263|NCT00998296|P11|Participant Flow|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the expansion phase which follows on the dose-escalation phase."
601264|NCT00998296|P10|Participant Flow|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the expansion phase which follows on the dose-escalation phase."
601265|NCT00998296|P9|Participant Flow|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601266|NCT00998296|P8|Participant Flow|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601268|NCT00998296|P6|Participant Flow|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601269|NCT00998296|P5|Participant Flow|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601270|NCT00998296|P4|Participant Flow|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601271|NCT00998296|P3|Participant Flow|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601272|NCT00998296|P2|Participant Flow|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601273|NCT00998296|P1|Participant Flow|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601274|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the expansion phase which follows on the dose-escalation phase."
601275|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the expansion phase which follows on the dose-escalation phase."
601276|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the expansion phase which follows on the dose-escalation phase."
601277|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the expansion phase which follows on the dose-escalation phase."
601465|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
601278|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the expansion phase which follows on the dose-escalation phase."
601279|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the expansion phase which follows on the dose-escalation phase."
601280|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the expansion phase which follows on the dose-escalation phase."
601281|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the expansion phase which follows on the dose-escalation phase."
601282|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601283|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601284|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg- Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601285|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg- Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601352|NCT00998309|O1|Outcome|Azithromycin -Without Past Medical History|Participants without Past Medical History who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601286|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the expansion phase which follows on the dose-escalation phase."
601287|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the expansion phase which follows on the dose-escalation phase."
601288|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601289|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601290|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601291|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601292|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601293|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601294|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601295|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601370|NCT00998309|O1|Outcome|Azithromycin -With Non-Drug Therapy|Participants without Non-Drug Therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601296|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601297|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the expansion phase which follows on the dose-escalation phase."
601298|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the expansion phase which follows on the dose-escalation phase."
601299|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601300|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601301|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601302|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601303|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601304|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601305|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601306|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601307|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601308|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).
This is a part of the expansion phase which follows on the dose-escalation phase."
601309|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the expansion phase which follows on the dose-escalation phase."
601310|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601311|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601312|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601313|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601314|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601315|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601316|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601317|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601318|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601319|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601320|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601321|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.
This is a part of the dose-escalation phase."
601322|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601323|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601324|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601325|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601353|NCT00998309|O2|Outcome|Azithromycin- With Renal Dysfunction|Participants with Renal Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601326|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601327|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).
This is a part of the dose-escalation phase."
601328|NCT00998296|E11|Reported Event|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d) plus film-coated tablet of Afatinib 30 mg (q.d)). This is a part of the expansion phase which follows on the dose-escalation phase."
601329|NCT00998296|E10|Reported Event|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).
This is a part of the expansion phase which follows on the dose-escalation phase."
601330|NCT00998296|E9|Reported Event|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
601331|NCT00998296|E8|Reported Event|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week
601332|NCT00998296|E7|Reported Event|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
601333|NCT00998296|E6|Reported Event|Nintedanib 200 mg +Afatinib 40 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
601334|NCT00998296|E5|Reported Event|Nintedanib 200 mg +Afatinib 30 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
601335|NCT00998296|E4|Reported Event|Nintedanib 200 mg +Afatinib 20 mg - Continuosly|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 20 mg was given continuously once daily (q.d.)
601371|NCT00998309|O2|Outcome|Azithromycin With Comcomittant Drugs|Participants with Comcomittant Drugs (CD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601336|NCT00998296|E3|Reported Event|Nintedanib 200 mg +Afatinib 10 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 10 mg was given continuously once daily (q.d.)
601337|NCT00998296|E2|Reported Event|Nintedanib 150 mg +Afatinib 40 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
601338|NCT00998296|E1|Reported Event|Nintedanib 150 mg +Afatinib 30 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
601339|NCT00998309|B1|Baseline|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601340|NCT00998309|P1|Participant Flow|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601341|NCT00998309|O2|Outcome|Azithromycin With Pregnancy in Female|Female participants with Pregnancy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601342|NCT00998309|O1|Outcome|Azithromycin Without Pregnancy in Female|Female participants without Pregnancy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601343|NCT00998309|O2|Outcome|Azithromycin With Non-drug Therapy|Participants with non-drug therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601344|NCT00998309|O1|Outcome|Azithromycin Without Non-drug Therapy|Participants without non-drug therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601345|NCT00998309|O2|Outcome|Azithromycin- With Comcomittant Drugs|Participants with comcomittant drugs who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601346|NCT00998309|O1|Outcome|Azithromycin Without Comcomittant Drugs|Participants without comcomittant drugs who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601347|NCT00998309|O2|Outcome|Azithromycin-with PATH|Participants with previous antibioutic treatment history (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601348|NCT00998309|O1|Outcome|Azithromycin Without PATH|Participants without previous antibioutic treatment history (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601349|NCT00998309|O2|Outcome|Azithromycin-with Complications|Participants with complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601350|NCT00998309|O1|Outcome|Azithromycin -Without Complications|Participants without complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601351|NCT00998309|O2|Outcome|Azithromycin- With Past Medical History|Participants with Past Medical History who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601683|NCT00999141|O5|Outcome|Very Satisfied|
601684|NCT00999141|O4|Outcome|Moderately Satisfied|
601354|NCT00998309|O1|Outcome|Azithromycin Without Renal Dysfunction|Participants without Renal Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601355|NCT00998309|O2|Outcome|Azithromycin With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601356|NCT00998309|O1|Outcome|Azithromycin Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601357|NCT00998309|O3|Outcome|Azithromycin-severe Infection|Participants with severe infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601358|NCT00998309|O2|Outcome|Azithromycin-moderate Infection|Participants with moderate infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601359|NCT00998309|O1|Outcome|Azithromycin-mild Infection|Participants with mild infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601360|NCT00998309|O3|Outcome|Azithromycin-Dental, or Oral Surgery Infection|Participants with Dental, or Oral Surgery Infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601361|NCT00998309|O2|Outcome|Azithromycin - Sexual Transmitted Infection|"Participants with Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infectionwho took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert."
601362|NCT00998309|O1|Outcome|Azithromycin - Skin and Soft Tissue Infection|Participants with Skin and Soft Tissue Infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601363|NCT00998309|O2|Outcome|Azithromycin >=65 Years|Participants >=65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601364|NCT00998309|O1|Outcome|Azithromycin <65 Years|Participants <65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601365|NCT00998309|O2|Outcome|Azithromycin Female|Female participants who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601366|NCT00998309|O1|Outcome|Azithromycin Male|Male participants who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601367|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601368|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601369|NCT00998309|O2|Outcome|Azithromycin-with Non-Drug Therapy|Participants with Non-Drug Therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601372|NCT00998309|O1|Outcome|Azithromycin Without Comcomittant Drugs|Participants without Comcomittant Drugs (CD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601373|NCT00998309|O2|Outcome|Azithromycin With PATH|Participants with Previous Antibiotic Treatment History (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601374|NCT00998309|O1|Outcome|Azithromycin Without PATH|Participants without Previous Antibiotic Treatment History (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601375|NCT00998309|O2|Outcome|Azithromycin With Complications|Participants with Complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601376|NCT00998309|O1|Outcome|Azithromycin Without Complications|Participants without Complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601377|NCT00998309|O2|Outcome|Azithromycin- With Past Medical History|Participants with Past Medical History (PMH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601378|NCT00998309|O1|Outcome|Azithromycin-without Past Medical History|Participants without Past Medical History (PMH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601379|NCT00998309|O2|Outcome|Azithromycin-with Renal Dysfunction|Participants with Renal Dysfunction (RD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601380|NCT00998309|O1|Outcome|Azithromycin-without Renal Dysfunction|Participants without Renal Dysfunction (RD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601381|NCT00998309|O2|Outcome|Azithromycin-with Hepatic Dysfunction|Participants with Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601382|NCT00998309|O1|Outcome|Azithromycin -Without Hepatic Dysfunction|Participants without Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601383|NCT00998309|O3|Outcome|Azithromycin-severe Infection|Participants with severe infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601384|NCT00998309|O2|Outcome|Azithromycin-moderate Infection|"Participants with moderate infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
, moderate infection, or severe in"
601385|NCT00998309|O1|Outcome|Azithromycin-mild Infection|Participants with mild infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601386|NCT00998309|O3|Outcome|Aazithromycin-Dental and Oral Surgery Infection|Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601387|NCT00998309|O2|Outcome|Azithromycin-Sexual Transmitted Infection|Participants with Sexual Transmitted Infection (STI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601388|NCT00998309|O1|Outcome|Azithromycin -Skin and Soft Tissue Infection|Participants with Skin and Soft Tissue Infection (SSTI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601389|NCT00998309|O2|Outcome|Azithromycin->=65 Years|Participants>=65 years who took Azithromycin SR as a single dose of 2 g (potency, as azithromycin) with an empty stomach according to Japanese Package Insert.
601390|NCT00998309|O1|Outcome|Azithromycin <65 Years|Participants with <65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601391|NCT00998309|O2|Outcome|Azithromycin-Female|Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601392|NCT00998309|O1|Outcome|Azithromycin -Male|Male participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601393|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601394|NCT00998309|E1|Reported Event|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
601395|NCT00998335|B3|Baseline|Total|Total of all reporting groups
601396|NCT00998335|B2|Baseline|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
601397|NCT00998335|B1|Baseline|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months
Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
601398|NCT00998335|P2|Participant Flow|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
601399|NCT00998335|P1|Participant Flow|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months
Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
601435|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric: RYGB
601436|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
601437|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric sparing: RYGB
601400|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations, insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart (insulin detemir plus aspart) will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated. This group will receive Insulin detemir and pre-meal insulin aspart.
Insulin detemir and pre-meal insulin aspart.: This group will receive Insulin detemir plus aspart. The group will start with Insulin detemir at bedtime. Then in three months they will Insulin aspart before breakfast, lunch and dinner."
601401|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl. This group will receive Long-acting bedtime insulin detemir (Levemir).
Long-acting bedtime insulin detemir (Levemir): This group will receive Insulin detemir. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
601402|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
601403|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.
Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
601404|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
601405|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
601486|NCT00998582|E2|Reported Event|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
601487|NCT00998582|E1|Reported Event|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
601488|NCT00998660|B4|Baseline|Total|Total of all reporting groups
601406|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
601407|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
601408|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
601409|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
601410|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
601411|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.
Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
601412|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
601413|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.
Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
601414|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
601415|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.
Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
601416|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
601417|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.
Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
601418|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
601419|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
601489|NCT00998660|B3|Baseline|Parkinsons Disease Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat Parkinson's Disease.
601685|NCT00999141|O3|Outcome|Somewhat Satisfied|
601686|NCT00999141|O2|Outcome|A Little Satisfied|
601420|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
601421|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
601422|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
601423|NCT00998335|O1|Outcome|Insulin Detemir x 3 Months (All Pts Had Liver MRS)|Liver fat by MRS measured after 3 months of insulin.
601424|NCT00998335|E2|Reported Event|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.
Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
601425|NCT00998335|E1|Reported Event|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months
Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
601426|NCT00998374|B3|Baseline|Total|Total of all reporting groups
601427|NCT00998374|B2|Baseline|Non-pyloric Sparing|Non-pyloric sparing: Roux-en-Y Gastric Bypass
601428|NCT00998374|B1|Baseline|Pyloric-sparing|Pyloric sparing: Sleeve Gastrectomy and Duodenal Switch
601429|NCT00998374|P2|Participant Flow|Non-pyloric Sparing|Non-pyloric sparing: Roux-en-Y Gastric Bypass (RYGB)
601430|NCT00998374|P1|Participant Flow|Pyloric-sparing|Pyloric: Sleeve Gastrectomy (SG) & Duodenal Switch (DS)
601431|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric: RYGB
601432|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
601433|NCT00998374|O2|Outcome|Non-pyloric|Non-pyloric: RYGB
601434|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
601441|NCT00998426|B1|Baseline|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.
Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. All participants will undergo two finger stick tests, one with a glucose-specific monitoring device(GS-POC) and one with a glucose non-specific monitoring device(GNS-POC) and a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose ). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
601442|NCT00998426|P1|Participant Flow|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.
Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
601443|NCT00998426|O1|Outcome|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.
Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device (GS-POC)and one with a glucose non-specific (GNS-POC) monitoring device; a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
601490|NCT00998660|B2|Baseline|Essential Tremor Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat Essential Tremor.
601687|NCT00999141|O1|Outcome|Not at All Satisfied|
601688|NCT00999141|O5|Outcome|Strongly Prefer SoC Side|
601444|NCT00998426|E2|Reported Event|Chronic Phase|"Study procedures will occur one time at least three (3) months post liver transplant. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.
glucose monitoring before and after HepaGam B administration: Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.
HepaGam B (Hepatitis B Immune Globulin (HBIG)): Subjects will be gi"
601445|NCT00998426|E1|Reported Event|Acute Phase|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.
Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
601446|NCT00998517|B4|Baseline|Total|Total of all reporting groups
601447|NCT00998517|B3|Baseline|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
601448|NCT00998517|B2|Baseline|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
601449|NCT00998517|B1|Baseline|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
601450|NCT00998517|P3|Participant Flow|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
601451|NCT00998517|P2|Participant Flow|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
601452|NCT00998517|P1|Participant Flow|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
601453|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
601454|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
601455|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
601456|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
601457|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
601458|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
601459|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
601460|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
601461|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
601462|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
601463|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
601754|NCT00999167|O2|Outcome|Placebo|6 mL BID
601466|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
601467|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
601468|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
601469|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
601470|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
601471|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
601472|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
601473|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
601474|NCT00998517|E3|Reported Event|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
601475|NCT00998517|E2|Reported Event|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
601476|NCT00998517|E1|Reported Event|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
601477|NCT00998582|B3|Baseline|Total|Total of all reporting groups
601478|NCT00998582|B2|Baseline|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
601479|NCT00998582|B1|Baseline|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
601480|NCT00998582|P2|Participant Flow|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
601481|NCT00998582|P1|Participant Flow|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
601482|NCT00998582|O2|Outcome|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
601483|NCT00998582|O1|Outcome|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
601484|NCT00998582|O2|Outcome|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
601485|NCT00998582|O1|Outcome|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
601492|NCT00998660|P1|Participant Flow|Patients Receiving an Activa RC Implant|Activa RC: Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
601493|NCT00998660|O1|Outcome|Patients Implanted With the Activa RC|All enrolled patients implanted with the Activa RC neurostimulator.
601494|NCT00998660|E1|Reported Event|Patients Implanted With the Activa RC|All enrolled patients implanted with the Activa RC neurostimulator.
601495|NCT00998738|B1|Baseline|Overall|
601496|NCT00998738|P1|Participant Flow|Overall|
601497|NCT00998738|O1|Outcome|Overall|
601498|NCT00998738|O1|Outcome|Overall|
601499|NCT00998738|O1|Outcome|Overall|
601500|NCT00998738|O1|Outcome|Overall|
601501|NCT00998738|O1|Outcome|Overall|
601502|NCT00998738|O1|Outcome|Overall|
601503|NCT00998738|O1|Outcome|Overall|
601504|NCT00998738|O1|Outcome|Overall|
601505|NCT00998738|O1|Outcome|Overall|
601506|NCT00998738|E1|Reported Event|Overall|
601507|NCT00998764|B3|Baseline|Total|Total of all reporting groups
601508|NCT00998764|B2|Baseline|Bapineuzumab/Bapineuzumab|Participants received Bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601509|NCT00998764|B1|Baseline|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study Bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601510|NCT00998764|P2|Participant Flow|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601511|NCT00998764|P1|Participant Flow|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by intravenous (IV) infusion approximately every 13 weeks up to week 195.
601512|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601513|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601514|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601515|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601516|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601517|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601560|NCT00998985|B9|Baseline|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
601518|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601519|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601520|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601521|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601522|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601523|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601524|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601525|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601526|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601527|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601528|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapineuzumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601529|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601689|NCT00999141|O4|Outcome|Somewhat Prefer SoC Side|
601530|NCT00998764|E2|Reported Event|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601531|NCT00998764|E1|Reported Event|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
601532|NCT00998868|B1|Baseline|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
601533|NCT00998868|P1|Participant Flow|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
601534|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
601535|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
601536|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
601537|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
601538|NCT00998868|E1|Reported Event|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
601539|NCT00998881|B3|Baseline|Total|Total of all reporting groups
601540|NCT00998881|B2|Baseline|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
601541|NCT00998881|B1|Baseline|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
601542|NCT00998881|P2|Participant Flow|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
601543|NCT00998881|P1|Participant Flow|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
601544|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
601545|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
601546|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
601547|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
601548|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
601549|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
601550|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
601551|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
601552|NCT00998881|E2|Reported Event|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
601553|NCT00998881|E1|Reported Event|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
601554|NCT00998985|B15|Baseline|Total|Total of all reporting groups
601555|NCT00998985|B14|Baseline|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
601556|NCT00998985|B13|Baseline|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
601557|NCT00998985|B12|Baseline|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
601558|NCT00998985|B11|Baseline|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601559|NCT00998985|B10|Baseline|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601561|NCT00998985|B8|Baseline|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601562|NCT00998985|B7|Baseline|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601563|NCT00998985|B6|Baseline|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601564|NCT00998985|B5|Baseline|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601565|NCT00998985|B4|Baseline|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601566|NCT00998985|B3|Baseline|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601567|NCT00998985|B2|Baseline|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601568|NCT00998985|B1|Baseline|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601569|NCT00998985|P14|Participant Flow|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
601570|NCT00998985|P13|Participant Flow|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
601571|NCT00998985|P12|Participant Flow|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
601572|NCT00998985|P11|Participant Flow|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601573|NCT00998985|P10|Participant Flow|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601574|NCT00998985|P9|Participant Flow|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
601575|NCT00998985|P8|Participant Flow|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601576|NCT00998985|P7|Participant Flow|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601577|NCT00998985|P6|Participant Flow|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601578|NCT00998985|P5|Participant Flow|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601579|NCT00998985|P4|Participant Flow|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601580|NCT00998985|P3|Participant Flow|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601581|NCT00998985|P2|Participant Flow|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601582|NCT00998985|P1|Participant Flow|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601583|NCT00998985|O14|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
601584|NCT00998985|O13|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
601585|NCT00998985|O12|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
601586|NCT00998985|O11|Outcome|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601587|NCT00998985|O10|Outcome|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601588|NCT00998985|O9|Outcome|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601589|NCT00998985|O8|Outcome|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601590|NCT00998985|O7|Outcome|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601591|NCT00998985|O6|Outcome|Placebo for Grazoprevir - GT1 and GT3|Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
601592|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601593|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601594|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601595|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601596|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601597|NCT00998985|O14|Outcome|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601598|NCT00998985|O13|Outcome|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601599|NCT00998985|O12|Outcome|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601600|NCT00998985|O11|Outcome|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601601|NCT00998985|O10|Outcome|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601602|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
601603|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
601604|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
601605|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
601606|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601607|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601608|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601609|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601610|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601611|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
601612|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
601613|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
601614|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
601615|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601616|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601617|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601618|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601619|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601620|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
601621|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
601622|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
601623|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
601624|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601625|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601626|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601627|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601628|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601629|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
601630|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
601631|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
601632|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
601633|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601634|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601635|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601636|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601637|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601638|NCT00998985|E9|Reported Event|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
601639|NCT00998985|E8|Reported Event|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
601640|NCT00998985|E7|Reported Event|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
601641|NCT00998985|E6|Reported Event|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
601642|NCT00998985|E5|Reported Event|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
601643|NCT00998985|E4|Reported Event|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
601644|NCT00998985|E3|Reported Event|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
601645|NCT00998985|E2|Reported Event|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
601646|NCT00998985|E1|Reported Event|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
601647|NCT00999037|B3|Baseline|Total|Total of all reporting groups
601648|NCT00999037|B2|Baseline|Placebo|Placebo: 1 inert tablet tid x 12 weeks
601649|NCT00999037|B1|Baseline|Renvela|"Daily renvela with meals for 12 weeks
Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
601650|NCT00999037|P2|Participant Flow|Placebo|Placebo (inert tablets): 1 tablet TID with meals for 12 weeks
601651|NCT00999037|P1|Participant Flow|Renvela|Sevelamer Carbonate (Renvela) 800 mg tablets: 1 tablet TID with meals for 12 weeks
601652|NCT00999037|O2|Outcome|Placebo|Placebo: 1 inert tablet tid x 12 weeks
601653|NCT00999037|O1|Outcome|Renvela|"Daily renvela with meals for 12 weeks
Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
601654|NCT00999037|O2|Outcome|Placebo|Placebo: 1 inert tablet tid x 12 weeks
601655|NCT00999037|O1|Outcome|Renvela|"Daily renvela with meals for 12 weeks
Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
601656|NCT00999037|O2|Outcome|Placebo|Placebo (1 inert tablet) PO TID with meals x 12 weeks
601657|NCT00999037|O1|Outcome|Renvela|Sevelamer Carbonate (800 mg tablet) PO TID with meals x 12 weeks
601658|NCT00999037|E2|Reported Event|Placebo|Placebo: 1 inert tablet tid x 12 weeks
601659|NCT00999037|E1|Reported Event|Renvela|"Daily renvela with meals for 12 weeks
Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
601660|NCT00999141|B1|Baseline|Facelift Participants|One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
601661|NCT00999141|P1|Participant Flow|Facelift Participants|One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
601662|NCT00999141|O2|Outcome|Related Facial Adverse Events|
601663|NCT00999141|O1|Outcome|Related Non-Facial Adverse Events|
601664|NCT00999141|O4|Outcome|SoC Side - Seroma|
601665|NCT00999141|O3|Outcome|FS VH S/D 4 S-apr Side - Seroma|
601666|NCT00999141|O2|Outcome|SoC Side - Hematoma|
601667|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Hematoma|
601668|NCT00999141|O5|Outcome|Confident|
601669|NCT00999141|O4|Outcome|Somewhat Confident|
601670|NCT00999141|O3|Outcome|Neutral|
601671|NCT00999141|O2|Outcome|Not Very Confident|
601672|NCT00999141|O1|Outcome|Not Confident|
601673|NCT00999141|O5|Outcome|Very Satisfied|
601674|NCT00999141|O4|Outcome|Moderately Satisfied|
601675|NCT00999141|O3|Outcome|Somewhat Satisfied|
601676|NCT00999141|O2|Outcome|A Little Satisfied|
601677|NCT00999141|O1|Outcome|Not at All Satisfied|
601678|NCT00999141|O5|Outcome|Very Satisfied|
601709|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
601710|NCT00999141|O3|Outcome|Participants With No Preference|
601711|NCT00999141|O2|Outcome|Participants Preferring SoC|
601712|NCT00999141|O1|Outcome|Participants Preferring FS VH S/D 4 S-apr|
601713|NCT00999141|O2|Outcome|Standard of Care (SoC)|
601714|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr|
601715|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
601716|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
601717|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
601718|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
601719|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
601720|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
601721|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
601722|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
601723|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
601724|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
601725|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
601726|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
601727|NCT00999141|O4|Outcome|Participants With No Hematoma/Seroma on Either Side|
601728|NCT00999141|O3|Outcome|Participants With Hematoma/Seroma on Both Sides|
601729|NCT00999141|O2|Outcome|Participants With Hematoma/Seroma on SoC Side|
601730|NCT00999141|O1|Outcome|Participants With Hematoma/Seroma on FS VH S/D 4 S-apr Side|
601731|NCT00999141|O2|Outcome|Standard of Care (SoC)|Participants With Hematoma/Seroma on SoC Side
601732|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr|Participants With Hematoma/Seroma on FS VH S/D 4 s-apr Side
601733|NCT00999141|O4|Outcome|Standard of Care (SoC) Side - Seroma|
601734|NCT00999141|O3|Outcome|Standard of Care (SoC) Side - Hematoma|
601735|NCT00999141|O2|Outcome|FS VH S/D 4 S-apr Side - Seroma|
601736|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Hematoma|
601737|NCT00999141|O2|Outcome|FS VH S/D 4 S-apr|
601738|NCT00999141|O1|Outcome|Standard of Care (SoC)|
601739|NCT00999141|E3|Reported Event|Non-localized AEs|AE affected a site other than either side of the face (ie, non-localized AE)
601740|NCT00999141|E2|Reported Event|Localized to FS VH S/D 4 S-apr Side of Face|AE was localized to the side of the face which was treated with FS VH S/D 4 s-apr
601741|NCT00999141|E1|Reported Event|Localized to SoC Side of Face|AE was localized to the side of the face which was treated with standard of care (SoC).
601742|NCT00999167|B3|Baseline|Total|Total of all reporting groups
601743|NCT00999167|B2|Baseline|Placebo|6 mL BID
601744|NCT00999167|B1|Baseline|HPN-100|6 mL BID
601745|NCT00999167|P3|Participant Flow|Placebo|Subjects will receive 6 mL BID placebo for 16 weeks (Part B)
601746|NCT00999167|P2|Participant Flow|HPN-100 6 mL|Subjects will receive 6 mL BID HPN-100 for 16 weeks (Part B)
601747|NCT00999167|P1|Participant Flow|HPN-100 6 mL and 9 mL|Subjects will undergo a one step dose escalation over 4 weeks. Subjects will initially receive 6 mL HPN-100 BID for 1 week. On Day 7 and following a satisfactory safety assessment of the subject, the dose will be escalated to 9 mL BID for an additional 3 weeks.
601748|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
601749|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
601755|NCT00999167|O1|Outcome|HPN-100|6 mL BID
601756|NCT00999167|O1|Outcome|HPN-100 BID|6 mL or 9 mL BID HPN-100 (Part A)
601757|NCT00999167|E3|Reported Event|Part B: Placebo|Matching HPN-100 placebo, 6 mL BID
601758|NCT00999167|E2|Reported Event|Part B: HPN-100|6 mL BID, equivalent to approximately 13.2 grams of HPN-100/day
601759|NCT00999167|E1|Reported Event|Part A: HPN-100|6 mL BID for 7 days followed by 9 mL BID for 21 days, equivalent to approximately 13.2 and 19.8 grams of HPN-100/day, respectively
601760|NCT00999466|B4|Baseline|Total|Total of all reporting groups
601761|NCT00999466|B3|Baseline|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601762|NCT00999466|B2|Baseline|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601763|NCT00999466|B1|Baseline|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601764|NCT00999466|P3|Participant Flow|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601765|NCT00999466|P2|Participant Flow|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601766|NCT00999466|P1|Participant Flow|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601767|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601768|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601769|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601770|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601771|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601772|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601773|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602161|NCT00989157|P1|Participant Flow|Control|Matched to bariatric subject via BMI, age and gender
601774|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601775|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601776|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601777|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601778|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601779|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601780|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601781|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601782|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601783|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601784|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601785|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601786|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601787|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601788|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601789|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601790|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601791|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601792|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601793|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601794|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601795|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601796|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601797|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601798|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601799|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601800|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601801|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601802|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601803|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601804|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602398|NCT00990093|O2|Outcome|Standard Catheter|SpeediCath Catheter
601805|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601806|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601807|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601808|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601809|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601810|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601811|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601812|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601813|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601814|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601815|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601816|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601817|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601818|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601819|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601820|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601821|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601822|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601823|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
618997|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
601824|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601825|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601826|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601827|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601828|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601829|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601830|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601831|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601832|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601833|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601834|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601835|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601836|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601837|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601838|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601839|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601840|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601841|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601842|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601843|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601844|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601845|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601846|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601847|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601848|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601849|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601850|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601851|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601852|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601853|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601904|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601854|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601855|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601856|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601857|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601858|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601859|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601860|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601861|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601862|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601863|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601864|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601865|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601866|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601867|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601868|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601869|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601870|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601871|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601872|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601873|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601874|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601875|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601876|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601877|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601878|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601879|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601880|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601881|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601882|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601883|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601884|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601885|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601886|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601887|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601888|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601889|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601890|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601891|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601892|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601893|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601894|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601895|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601896|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601897|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601898|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601899|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601900|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601901|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601902|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601903|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601905|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601906|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601907|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601908|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601909|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601910|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601911|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601912|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601913|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601914|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601915|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601916|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601917|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601918|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601919|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601920|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601921|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601922|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601923|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601924|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601925|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601926|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601927|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601928|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601929|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601930|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601931|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601932|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601933|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601934|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601935|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601936|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601937|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601938|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601939|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601940|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601941|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601942|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601943|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601944|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601945|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601946|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601947|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601948|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601949|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601950|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601951|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601952|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601953|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601954|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601955|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601956|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601957|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601958|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601959|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601960|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601961|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601962|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601963|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601964|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601965|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601966|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601967|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601968|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601969|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601970|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601971|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601972|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601973|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
618998|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
601974|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601975|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601976|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601977|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601978|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601979|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601980|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601981|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601982|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601983|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601984|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601985|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601986|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601987|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601988|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601989|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601990|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601991|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601992|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601993|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601994|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601995|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601996|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
601997|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
601998|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
601999|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602000|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602001|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602002|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602003|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602052|NCT00999544|O5|Outcome|Placebo- 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
602004|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602005|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602006|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602007|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602008|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602009|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602010|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602011|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602012|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602013|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602014|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602015|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602016|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602017|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602018|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602019|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602020|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602021|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602022|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602023|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602024|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602025|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602026|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602027|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602028|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602029|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602030|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602031|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602032|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602033|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602034|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602035|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602036|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602037|NCT00999466|E3|Reported Event|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
602038|NCT00999466|E2|Reported Event|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
602039|NCT00999466|E1|Reported Event|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
602040|NCT00999544|B1|Baseline|Crossover Within Subject|All subjects were exposed to every condition.
602041|NCT00999544|P1|Participant Flow|Within-subject Crossover Design|All subjects received exposure to every study condition in random order. During each of 15 separate test sessions, subjects received pretreatment with aprepitant (0, 40 or 200 mg) followed by a single challenge with a oxycodone (15 or 30, intranasal; 20 or 40 mg) or placebo. The fifteen dose conditions were administered in random order and each subject was exposed to each dose combination once.
602042|NCT00999544|O15|Outcome|Aprepitant 200 mg- 40 Oxycodone Oral|All subjects received exposure to this study condition once.
602043|NCT00999544|O14|Outcome|Aprepitant 200 mg- 20 Oxycodone Oral|All subjects received exposure to this study condition once.
602044|NCT00999544|O13|Outcome|Aprepitant 200 mg - 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
602045|NCT00999544|O12|Outcome|Aprepitant 200 mg - 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
602046|NCT00999544|O11|Outcome|Aprepitant 40 mg - 40 mg Oxycodone Oral|All subjects received exposure to this study condition once.
602047|NCT00999544|O10|Outcome|Aprepitant 40 mg- 20 mg Oxycodone Oral|All subjects received exposure to this study condition once.
602048|NCT00999544|O9|Outcome|Aprepitant 40 mg - 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
602049|NCT00999544|O8|Outcome|Aprepitant 40 mg- 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
602050|NCT00999544|O7|Outcome|Placebo - 40 mg Oxycodone Oral|All subjects received exposure to this study condition once.
602051|NCT00999544|O6|Outcome|Placebo- 20 mg Oxycodone Oral|All subjects received exposure to this study condition once.
608311|NCT01014624|O2|Outcome|Clopidogrel 75 mg Daily|
602053|NCT00999544|O4|Outcome|Placebo- 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
602054|NCT00999544|O3|Outcome|Aprepitant 200 mg- Placebo|All subjects received exposure to this study condition once.
602055|NCT00999544|O2|Outcome|Aprepitant 40 mg - Placebo|All subjects received exposure to this study condition once.
602056|NCT00999544|O1|Outcome|Placebo-Placebo (in and po)|All subjects received exposure to this study condition once.
602057|NCT00999544|E1|Reported Event|Within-subject Crossover Design|All subjects received exposure to every study condition in random order. This was not a parallel group design.
602058|NCT00999596|B1|Baseline|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
602059|NCT00999596|P1|Participant Flow|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
602060|NCT00999596|O2|Outcome|FFDM Mammograms Score = Fail|Mammogram sets from the Philips Digital System with Fail score for Image Quality
602061|NCT00999596|O1|Outcome|FFDM Mammograms Score = Pass|Mammogram sets from the Philips Digital System with Pass score for Image Quality
602062|NCT00999596|E1|Reported Event|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
602063|NCT00999661|B1|Baseline|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
602064|NCT00999661|P1|Participant Flow|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
602065|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
602066|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
602067|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
602068|NCT00999661|E1|Reported Event|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
602069|NCT00999687|B1|Baseline|All Participants (Indigo Naturalis Oil Extract /Olive Oil)|In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks.
618999|NCT01037244|O4|Outcome|Placebo|Placebo tablets
602070|NCT00999687|P1|Participant Flow|All Participants (Indigo Naturalis Oil Extract /Olive Oil)|In all participants, indigo naturalis oil extract (INOE) was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and INOE was applied to both hands twice daily for another 12 weeks.
602071|NCT00999687|O2|Outcome|Control Group|Using Olive Oil from week 0 to week 12, then transfer to Indigo Naturalis Oil Extract from week 13 to week 24
602072|NCT00999687|O1|Outcome|Experimental Group|Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.
602073|NCT00999687|O2|Outcome|Control Group|Using Olive Oil from week 0 to week 12, then change to Indigo Naturalis Oil Extract (INOE) from week 13 to week 24.
602074|NCT00999687|O1|Outcome|Experimental Group|Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.
602075|NCT00999687|E1|Reported Event|All Participants (Indigo Naturalis Oil Extreact/Olive Oil)|"Experimental group: randomized to receive Indigo Naturalis Oil Extract first; Control group: randomized to receive Olive Oil first.
In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks."
602076|NCT00999804|B3|Baseline|Total|Total of all reporting groups
602077|NCT00999804|B2|Baseline|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602078|NCT00999804|B1|Baseline|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602079|NCT00999804|P2|Participant Flow|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602080|NCT00999804|P1|Participant Flow|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602081|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602082|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602183|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602083|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602084|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602085|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602086|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602087|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602088|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602089|NCT00999804|E2|Reported Event|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602090|NCT00999804|E1|Reported Event|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Lapatinib: 1000 mg by mouth daily
Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)
Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
602091|NCT00999830|B3|Baseline|Total|Total of all reporting groups
602092|NCT00999830|B2|Baseline|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
602093|NCT00999830|B1|Baseline|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
602094|NCT00999830|P2|Participant Flow|Arm B: IPH2101 2mg/kg|IPH2101 Fully human anti-KIR monoclonal antibody : 2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
602095|NCT00999830|P1|Participant Flow|Arm A: IPH2101 0.2mg/Kg|IPH2101 Fully human anti-KIR monoclonal antibody : 0.2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
602096|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
602097|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
602098|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
602099|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
602100|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
602101|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
602102|NCT00999830|E2|Reported Event|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
602103|NCT00999830|E1|Reported Event|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
602104|NCT00989014|B5|Baseline|Total|Total of all reporting groups
602105|NCT00989014|B4|Baseline|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
602106|NCT00989014|B3|Baseline|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
602107|NCT00989014|B2|Baseline|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
602108|NCT00989014|B1|Baseline|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
602109|NCT00989014|P4|Participant Flow|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
602110|NCT00989014|P3|Participant Flow|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
602111|NCT00989014|P2|Participant Flow|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
602112|NCT00989014|P1|Participant Flow|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
602113|NCT00989014|O4|Outcome|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
602114|NCT00989014|O3|Outcome|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
602115|NCT00989014|O2|Outcome|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
602116|NCT00989014|O1|Outcome|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
602117|NCT00989014|E4|Reported Event|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
602118|NCT00989014|E3|Reported Event|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
602119|NCT00989014|E2|Reported Event|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
602120|NCT00989014|E1|Reported Event|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
602121|NCT00989092|B3|Baseline|Total|Total of all reporting groups
602184|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602122|NCT00989092|B2|Baseline|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602123|NCT00989092|B1|Baseline|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602124|NCT00989092|P2|Participant Flow|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602125|NCT00989092|P1|Participant Flow|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602126|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602127|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602156|NCT00989092|E1|Reported Event|Treatment Arm|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.
602128|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602129|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602130|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602131|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602132|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602133|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602134|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602399|NCT00990093|O1|Outcome|Test Catheter|SpeediCath Compact Male Catheter
602135|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602136|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602137|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602138|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602139|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602140|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602141|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602157|NCT00989157|B3|Baseline|Total|Total of all reporting groups
602142|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602143|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602144|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602145|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602146|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602147|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602148|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602149|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602150|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602151|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602152|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
602153|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
602154|NCT00989092|E3|Reported Event|Observation Arm Not Treated|Participants in the observation group who did not receive any darbepoetin alfa treatment.
602155|NCT00989092|E2|Reported Event|Observation Arm Treated|Participants in the observation group who received darbepoetin alfa, initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL. Adverse events for participants in this group could have been reported at any time during the study; and therefore, may have occurred before darbepoetin alfa administration.
602158|NCT00989157|B2|Baseline|Control|Subjects matched to the bariatric subjects via BMI, age and gender
602159|NCT00989157|B1|Baseline|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
602160|NCT00989157|P2|Participant Flow|Bariatric|One year post surgery
602162|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
602163|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
602164|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
602165|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
602166|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
602167|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
602168|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
602169|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
602170|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender
602171|NCT00989157|O1|Outcome|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
602172|NCT00989157|E2|Reported Event|Control|Subjects matched to the bariatric subjects via BMI, age and gender
602173|NCT00989157|E1|Reported Event|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
602174|NCT00989196|B1|Baseline|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
602175|NCT00989196|P2|Participant Flow|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602176|NCT00989196|P1|Participant Flow|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602177|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
602178|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
602179|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602180|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602181|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602182|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602185|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602186|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602187|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602188|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602189|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602190|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
602191|NCT00989196|O2|Outcome|Kogenate FS|Kogenate FS 50 IU/kg for PK dose
602192|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII 50 IU/kg for PK dose
602193|NCT00989196|E1|Reported Event|Human cl rhFVIII and Kogenate FS|All participants. Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK period. After the PK period all participants received Human-cl rhFVIII in the treatment period.
602194|NCT00989235|B3|Baseline|Total|Total of all reporting groups
602195|NCT00989235|B2|Baseline|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602196|NCT00989235|B1|Baseline|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602315|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
602316|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
602197|NCT00989235|P2|Participant Flow|Abatacept (5 mg/kg)|All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.
602198|NCT00989235|P1|Participant Flow|Abatacept (10 mg/kg)|All subjects in the sub-study randomized to receive double-blind abatacept 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.
602199|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
602200|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
602201|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
602202|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
602203|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
602204|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
602205|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
602206|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
602207|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
602208|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
602209|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
602210|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
602211|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
602212|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
602213|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
602214|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
602215|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
602216|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
602217|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602218|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602219|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602220|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602221|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602222|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602223|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602224|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602225|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602226|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602227|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602228|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602229|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602230|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602231|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602232|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602233|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602234|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602235|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602236|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602237|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
602238|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
602239|NCT00989235|E3|Reported Event|Abatacept 10mg/kg (Open-Label)|
602240|NCT00989235|E2|Reported Event|Abatacept 10mg/kg (ST)|
602241|NCT00989235|E1|Reported Event|Abatacept 5mg/kg (ST)|
602242|NCT00989586|B3|Baseline|Total|Total of all reporting groups
602317|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
602318|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
602319|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
619000|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
602243|NCT00989586|B2|Baseline|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.
veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
602244|NCT00989586|B1|Baseline|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.
milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
602245|NCT00989586|P2|Participant Flow|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.
veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
602246|NCT00989586|P1|Participant Flow|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.
milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
602286|NCT00989768|B1|Baseline|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
602459|NCT00990561|O1|Outcome|Ultravate 0.05% Ointment Twice Daily|Ultravate twice daily to affected area.
602247|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.
Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
602248|NCT00989586|O1|Outcome|Patients Dosed at 20mg/kg|First dose milatuzumab pharmacokinetics for patients doses at 20 mg/kg
602249|NCT00989586|O1|Outcome|Patients Dosed at 20mg/kg|First dose milatuzumab pharmacokinetics for patients doses at 20 mg/kg
602250|NCT00989586|O2|Outcome|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.
veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
602251|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.
milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
602252|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.
Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
602320|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
602253|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.
Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
602254|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.
Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
602255|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.
milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
602256|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.
milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
602257|NCT00989586|E1|Reported Event|All Patients From Phase I and Phase II|Toxicities were graded according to NCI Common Toxicity Criteria for Adverse Events version 3.0 and classified as either unrelated, unlikely, possibly, probably or definitely related to study treatment.
602287|NCT00989768|P1|Participant Flow|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
602288|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered two units to the other side of frontal region
608312|NCT01014624|O1|Outcome|Prasugrel 10 mg Daily|
602258|NCT00989664|B1|Baseline|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602259|NCT00989664|P1|Participant Flow|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602260|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602261|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602262|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602263|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602264|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602265|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602266|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602460|NCT00990561|E2|Reported Event|Ultravate Once a Day|Ultravate ointment applied once daily
602267|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602268|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602269|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602270|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602271|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
603810|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
602272|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602273|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602274|NCT00989664|O2|Outcome|LQCR|Participants treated with at least two chemotherapy regimens before enrolling in study BEX104504
602275|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602289|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
602290|NCT00989768|O2|Outcome|Botox ® 2U|Two units of Botox® was administered to the other side of the frontal region.
602291|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
602461|NCT00990561|E1|Reported Event|Ultravate Twice a Day|
602276|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602277|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602278|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602279|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602280|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602281|NCT00989664|O2|Outcome|LQCR|Participants previously treated with at least two chemotherapy regimes before enrolling in Study BEX104504
602321|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
602322|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
602323|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
602324|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
602282|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602283|NCT00989664|O2|Outcome|LQCR|Participants previously treated with at least two chemotherapy regimes before enrolling in Study BEX104504
602284|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602285|NCT00989664|E1|Reported Event|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
602292|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered to the other side of the frontal region.
602293|NCT00989768|O1|Outcome|Dysport® 5U|Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
602294|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered to the other side of the frontal region.
602295|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
602296|NCT00989768|E1|Reported Event|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
602297|NCT00989833|B4|Baseline|Total|Total of all reporting groups
602298|NCT00989833|B3|Baseline|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
602299|NCT00989833|B2|Baseline|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
602300|NCT00989833|B1|Baseline|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
602301|NCT00989833|P3|Participant Flow|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
602302|NCT00989833|P2|Participant Flow|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
602303|NCT00989833|P1|Participant Flow|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
602304|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
602305|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
602306|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
602307|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
602308|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
602309|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
602310|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
602311|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
602312|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
602313|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
602314|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
602325|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
602326|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
602327|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
602328|NCT00989833|E3|Reported Event|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
602329|NCT00989833|E2|Reported Event|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
602330|NCT00989833|E1|Reported Event|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
602331|NCT00989911|B1|Baseline|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
602332|NCT00989911|P1|Participant Flow|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
602333|NCT00989911|O1|Outcome|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
602334|NCT00989911|E1|Reported Event|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
602335|NCT00989950|B5|Baseline|Total|Total of all reporting groups
602336|NCT00989950|B4|Baseline|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602337|NCT00989950|B3|Baseline|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602338|NCT00989950|B2|Baseline|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602339|NCT00989950|B1|Baseline|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602340|NCT00989950|P4|Participant Flow|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602341|NCT00989950|P3|Participant Flow|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602342|NCT00989950|P2|Participant Flow|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602343|NCT00989950|P1|Participant Flow|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602344|NCT00989950|O4|Outcome|12 hr Wear|Result for all patients when patch worn for 12 hrs/day
602345|NCT00989950|O3|Outcome|11 hr Wear|Result for all patients when patch worn for 11 hrs/day
602346|NCT00989950|O2|Outcome|10 hr Wear|Result for all patients when patch worn for 10 hrs/day
602347|NCT00989950|O1|Outcome|9 hr Wear|Result for all patients when patch worn for 9 hrs/day
602348|NCT00989950|E4|Reported Event|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602349|NCT00989950|E3|Reported Event|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602350|NCT00989950|E2|Reported Event|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602351|NCT00989950|E1|Reported Event|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
602352|NCT00989989|B4|Baseline|Total|Total of all reporting groups
602353|NCT00989989|B3|Baseline|Laser Control|Active laser treatment plus sham intravitreal injections.
602354|NCT00989989|B2|Baseline|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602355|NCT00989989|B1|Baseline|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602356|NCT00989989|P3|Participant Flow|Laser Control|Active laser treatment plus sham intravitreal injections.
602357|NCT00989989|P2|Participant Flow|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602358|NCT00989989|P1|Participant Flow|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602359|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
602360|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602361|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602362|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
602363|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602364|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602365|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
602366|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602367|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602368|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
602369|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
603811|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
602370|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602371|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
602372|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602373|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602374|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
602375|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602376|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602377|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
602378|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602379|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602380|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
602381|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602382|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602383|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
602384|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602385|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602386|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
602387|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602388|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602389|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
602390|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602391|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602392|NCT00989989|E3|Reported Event|Laser Control|Active laser treatment plus sham intravitreal injections.
602393|NCT00989989|E2|Reported Event|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
602394|NCT00989989|E1|Reported Event|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
602395|NCT00990093|B1|Baseline|Entire Study Population|
602396|NCT00990093|P2|Participant Flow|B: First Standard Catheter Then Test Catheter|Test catheter is a CH 12 hydrophilic coated intermittent catheter
602397|NCT00990093|P1|Participant Flow|A: First Test Catheter Then Standard Catheter|Test catheter is a CH 12 hydrophilic coated intermittent catheter
602400|NCT00990093|E2|Reported Event|Standard Catheter|SpeediCath, CH 12 hydrophilic coated intermittent catheter
602401|NCT00990093|E1|Reported Event|Test Catheter|SpeediCath Compact Male
602402|NCT00990106|B3|Baseline|Total|Total of all reporting groups
602403|NCT00990106|B2|Baseline|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
602404|NCT00990106|B1|Baseline|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
602405|NCT00990106|P2|Participant Flow|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
602406|NCT00990106|P1|Participant Flow|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
602407|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
602408|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
602409|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
602410|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
602411|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
602412|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
602413|NCT00990106|E2|Reported Event|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
602414|NCT00990106|E1|Reported Event|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
602415|NCT00990184|B1|Baseline|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
602416|NCT00990184|P1|Participant Flow|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
602417|NCT00990184|O1|Outcome|Colesevelam|Effect of colesevelam treatment compared to baseline (end of two week placebo run in period)
602418|NCT00990184|O1|Outcome|Colesevelam 3.75 g Daily|Medication used to treat people with increased cholesterol levels
602419|NCT00990184|O1|Outcome|Colesevelam|Effect of colesevelam treatment compared to baseline
602420|NCT00990184|E1|Reported Event|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
602421|NCT00990340|B3|Baseline|Total|Total of all reporting groups
602422|NCT00990340|B2|Baseline|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
602423|NCT00990340|B1|Baseline|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
602424|NCT00990340|P2|Participant Flow|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
602425|NCT00990340|P1|Participant Flow|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
602426|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
602427|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
602428|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
602429|NCT00990340|O1|Outcome|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
602430|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
602431|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
602483|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
602432|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
602433|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
602434|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
602435|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
602436|NCT00990340|E2|Reported Event|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
602437|NCT00990340|E1|Reported Event|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
602438|NCT00990509|B3|Baseline|Total|Total of all reporting groups
602439|NCT00990509|B2|Baseline|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602440|NCT00990509|B1|Baseline|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602441|NCT00990509|P2|Participant Flow|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602442|NCT00990509|P1|Participant Flow|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602443|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602444|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602445|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602446|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602447|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602448|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602449|NCT00990509|E2|Reported Event|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602450|NCT00990509|E1|Reported Event|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)"
602451|NCT00990561|B3|Baseline|Total|Total of all reporting groups
602452|NCT00990561|B2|Baseline|Ultravate Once a Day|Ultravate ointment applied once daily
602453|NCT00990561|B1|Baseline|Ultravate Twice a Day|
602454|NCT00990561|P4|Participant Flow|No Treatment|
602455|NCT00990561|P3|Participant Flow|Lac-Hydrin Topically Twice a Day|
602456|NCT00990561|P2|Participant Flow|Once Daily Topical Ultravate Ointment + LacHydrin Lotion|
602457|NCT00990561|P1|Participant Flow|Twice Daily Topical Ultravate Ointment + LacHyrin Twice Daily|
602458|NCT00990561|O2|Outcome|Ultravate 0.05% Ointment Once Daily|Ultravate one daily to affected area.
602462|NCT00990652|B1|Baseline|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
602463|NCT00990652|P1|Participant Flow|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
602464|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.
Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).
Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
602465|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.
Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).
Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
602557|NCT00991809|B1|Baseline|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.
Alfentanil : 15 mcg/kg IM"
602466|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.
Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).
Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
602467|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.
Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).
Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
602468|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
602469|NCT00990652|E1|Reported Event|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.
Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).
Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
602470|NCT00990704|B3|Baseline|Total|Total of all reporting groups
602471|NCT00990704|B2|Baseline|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
602472|NCT00990704|B1|Baseline|Paricalcitol|2 mcg with incremental of 1 mcg
602473|NCT00990704|P2|Participant Flow|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
602474|NCT00990704|P1|Participant Flow|Paricalcitol|2 mcg with incremental of 1 mcg
602475|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
602476|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
602477|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
602478|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
602479|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
602480|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
602481|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
602482|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
602484|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
602485|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
602486|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
602487|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
602488|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
602489|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
602490|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
602491|NCT00990704|E2|Reported Event|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
602492|NCT00990704|E1|Reported Event|Paricalcitol|2 mcg with incremental of 1 mcg
602493|NCT00990769|B3|Baseline|Total|Total of all reporting groups
602494|NCT00990769|B2|Baseline|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
602495|NCT00990769|B1|Baseline|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
602496|NCT00990769|P2|Participant Flow|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
602497|NCT00990769|P1|Participant Flow|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
602498|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
602499|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
602500|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
602501|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
602502|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
602503|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
602504|NCT00990769|E2|Reported Event|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
602505|NCT00990769|E1|Reported Event|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
602506|NCT00990782|B1|Baseline|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.
PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
602507|NCT00990782|P1|Participant Flow|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.
PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
602508|NCT00990782|O1|Outcome|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.
PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
602509|NCT00990782|O1|Outcome|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.
PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
602510|NCT00990782|E1|Reported Event|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.
PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
602511|NCT00990821|B15|Baseline|Total|Total of all reporting groups
602512|NCT00990821|B14|Baseline|Part V, Treatment Sequence 6|115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
602513|NCT00990821|B13|Baseline|Part V, Treatment Sequence 5|100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
602514|NCT00990821|B12|Baseline|Part V, Treatment Sequence 4|125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
602515|NCT00990821|B11|Baseline|Part V, Treatment Sequence 3|115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
602516|NCT00990821|B10|Baseline|Part V, Treatment Sequence 2|100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
602517|NCT00990821|B9|Baseline|Part V, Treatment Sequence 1|125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
602518|NCT00990821|B8|Baseline|Part IV|40 mg MK-0517 (non-PS80 formulation)
602519|NCT00990821|B7|Baseline|Part III, Panel 2|40 mg MK-0517 (non-PS80)
602520|NCT00990821|B6|Baseline|Part III, Panel 1, Treatment Sequence 2|40 mg MK-0517 (non-PS80) → 125 mg aprepitant
602521|NCT00990821|B5|Baseline|Part III, Panel 1, Treatment Sequence 1|125 mg aprepitant → 90 mg MK-0517 (PS80)
602522|NCT00990821|B4|Baseline|Part II|2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
602523|NCT00990821|B3|Baseline|Part I, Panel C|40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
602524|NCT00990821|B2|Baseline|Part I, Panel B|100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
602525|NCT00990821|B1|Baseline|Part I, Panel A|100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant
602526|NCT00990821|P14|Participant Flow|Part V, Treatment Sequence 6|115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
602527|NCT00990821|P13|Participant Flow|Part V, Treatment Sequence 5|100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
602528|NCT00990821|P12|Participant Flow|Part V, Treatment Sequence 4|125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
602529|NCT00990821|P11|Participant Flow|Part V, Treatment Sequence 3|115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
602530|NCT00990821|P10|Participant Flow|Part V, Treatment Sequence 2|100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
602531|NCT00990821|P9|Participant Flow|Part V, Treatment Sequence 1|125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
602532|NCT00990821|P8|Participant Flow|Part IV|40 mg MK-0517 (non-PS80 formulation)
602533|NCT00990821|P7|Participant Flow|Part III, Panel 2|40 mg MK-0517 (non-PS80)
602534|NCT00990821|P6|Participant Flow|Part III, Panel 1, Treatment Sequence 2|40 mg MK-0517 (non-PS80) → 125 mg aprepitant
602535|NCT00990821|P5|Participant Flow|Part III, Panel 1, Treatment Sequence 1|125 mg aprepitant → 90 mg MK-0517 (PS80)
602536|NCT00990821|P4|Participant Flow|Part II|2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
602537|NCT00990821|P3|Participant Flow|Part I, Panel C|40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
602538|NCT00990821|P2|Participant Flow|Part I, Panel B|100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
602539|NCT00990821|P1|Participant Flow|Part I, Panel A|100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant
602540|NCT00990821|O3|Outcome|MK-0517 (115 mg)|115 mg of MK0517 (PS80 formulation) as an IV (intravenous) administered over 15 minutes
602541|NCT00990821|O2|Outcome|MK-0517 (100 mg)|100 mg of MK0517 (PS80 formulation) as an IV (intravenous) administered over 15 minutes
602542|NCT00990821|O1|Outcome|Aprepitant (125 mg)|A single oral dose with an Aprepitant capsule
602543|NCT00990821|E12|Reported Event|2 mg Midazolam|Midazolam administered as a single oral solution
602544|NCT00990821|E11|Reported Event|125 mg Aprepitant|Aprepitant administered as a single oral capsule
602545|NCT00990821|E10|Reported Event|40 mg Aprepitant|Aprepitant administered by a single oral capsule
602546|NCT00990821|E9|Reported Event|Placebo|Placebo matching MK-0517 (PS80 or non-PS80)
602547|NCT00990821|E8|Reported Event|150 mg MK-0517 (Non-PS80)|MK-0517, PS80 formulation, administered with a single IV administration
602548|NCT00990821|E7|Reported Event|100 mg MK-0517 (Non-PS80)|MK-0517, PS80 formulation, administered with a single IV administration
602549|NCT00990821|E6|Reported Event|40 mg MK-0517 (Non-PS80)|MK-0517, non-PS80 formulation, administered with a single IV administration
602550|NCT00990821|E5|Reported Event|150 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
602551|NCT00990821|E4|Reported Event|115 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
602552|NCT00990821|E3|Reported Event|100 mg MK-0517 (PS80) + 2 mg Midazolam|PS80 formulation, administered with a single IV administration and a single oral administration of midazolam
602553|NCT00990821|E2|Reported Event|100 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
602554|NCT00990821|E1|Reported Event|90 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
602555|NCT00991809|B3|Baseline|Total|Total of all reporting groups
602556|NCT00991809|B2|Baseline|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.
Diphenhydramine : 25 mg IM"
602558|NCT00991809|P2|Participant Flow|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.
Diphenhydramine : 25 mg IM"
602559|NCT00991809|P1|Participant Flow|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.
Alfentanil : 15 mcg/kg IM"
602560|NCT00991809|O2|Outcome|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.
Diphenhydramine : 25 mg IM"
602561|NCT00991809|O1|Outcome|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.
Alfentanil : 15 mcg/kg IM"
602562|NCT00991809|E2|Reported Event|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.
Diphenhydramine : 25 mg IM"
602563|NCT00991809|E1|Reported Event|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.
Alfentanil : 15 mcg/kg IM"
602564|NCT00991939|B3|Baseline|Total|Total of all reporting groups
602565|NCT00991939|B2|Baseline|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602566|NCT00991939|B1|Baseline|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602567|NCT00991939|P2|Participant Flow|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602568|NCT00991939|P1|Participant Flow|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602569|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602674|NCT00992264|B5|Baseline|Randomization Arm: 5|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [no].
602570|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602571|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602572|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602573|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602574|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602575|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602576|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602577|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602578|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602579|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602580|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602581|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602582|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602583|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602584|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602675|NCT00992264|B4|Baseline|Randomization Arm: 4|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [yes].
602585|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602586|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602587|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602588|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602589|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602590|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602591|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602592|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602593|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602594|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602595|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602596|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602597|NCT00991939|E2|Reported Event|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
602598|NCT00991939|E1|Reported Event|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
602599|NCT00991952|B3|Baseline|Total|Total of all reporting groups
602600|NCT00991952|B2|Baseline|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
602676|NCT00992264|B3|Baseline|Randomization Arm: 3|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [yes].
602601|NCT00991952|B1|Baseline|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
602602|NCT00991952|P2|Participant Flow|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
602603|NCT00991952|P1|Participant Flow|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
602604|NCT00991952|O2|Outcome|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
602605|NCT00991952|O1|Outcome|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
602606|NCT00991952|E2|Reported Event|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
602607|NCT00991952|E1|Reported Event|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
602608|NCT00992017|B1|Baseline|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
602609|NCT00992017|P1|Participant Flow|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
602610|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received the H1N1 vaccines.
602611|NCT00992017|O1|Outcome|H1N1 Vaccine|The pregnant women who received the H1N1 vaccinations.
602612|NCT00992017|O1|Outcome|Infants|Infants born to pregnant women who received H1N1 vaccines.
602613|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received the H1N1 vaccines.
602614|NCT00992017|O1|Outcome|Infants|Infants born to pregnant women who received H1N1 vaccines.
602615|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received H1N1 vaccinations.
602616|NCT00992017|O1|Outcome|H1N1 Vaccine|The pregnant women who received the H1N1 vaccinations.
602617|NCT00992017|O1|Outcome|Vaccinated Study Participants|Pregnant women who received at least one H1N1 vaccination.
619001|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
602618|NCT00992017|O1|Outcome|Vaccinated Study Participants|Pregnant women who received at least one H1N1 vaccination.
602619|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women enrolled in the study.
602620|NCT00992017|E1|Reported Event|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
602621|NCT00992056|B3|Baseline|Total|Total of all reporting groups
602622|NCT00992056|B2|Baseline|Nebivolol/Metoprolol|Nebivolol 5 mg titrated to 10 mg then Metoprolol 50 mg titrated to 100 mg
602623|NCT00992056|B1|Baseline|Metoprolol/Nebivolol|Metoprolol 50 mg titrated to 100 mg then Nebivolol 5 mg titrated to 10 mg
602624|NCT00992056|P2|Participant Flow|Metoprolol/Nebivolol|Metoprolol 50 mg titrated to 100 mg then nebivolol 5 mg titrated to 10 mg
602625|NCT00992056|P1|Participant Flow|Nebivolol/Metoprolol|Nebivolol 5 mg titrated to 10 mg then Metoprolol 50mg titrated to 100 mg.
602626|NCT00992056|O2|Outcome|Nebivolol|Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
602627|NCT00992056|O1|Outcome|Metoprolol|Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.
602628|NCT00992056|E2|Reported Event|Nebivolol|Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
602629|NCT00992056|E1|Reported Event|Metoprolol|Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.
602630|NCT00992108|B3|Baseline|Total|Total of all reporting groups
602631|NCT00992108|B2|Baseline|Botulinum|chemodenervation: botulinum toxin
602632|NCT00992108|B1|Baseline|Lidocaine|"lidocaine injection group
lidocaine: 1cc 1%"
602633|NCT00992108|P2|Participant Flow|Botulinum|chemodenervation: botulinum toxin
602634|NCT00992108|P1|Participant Flow|Lidocaine|"lidocaine injection group
lidocaine: 1cc 1%"
602635|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
602636|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group
lidocaine: 1cc 1%"
602637|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
602638|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group
lidocaine: 1cc 1%"
602639|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
602640|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group
lidocaine: 1cc 1%"
602641|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
602642|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group
lidocaine: 1cc 1%"
602643|NCT00992108|E2|Reported Event|Botulinum|chemodenervation: botulinum toxin
602644|NCT00992108|E1|Reported Event|Lidocaine|"lidocaine injection group
lidocaine: 1cc 1%"
608313|NCT01014624|E2|Reported Event|Clopidogrel 75mg/ Daily|
602645|NCT00992186|B1|Baseline|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602646|NCT00992186|P1|Participant Flow|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602647|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602648|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602649|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602650|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602651|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602652|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602653|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602654|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602655|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602656|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602657|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602658|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602659|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602779|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
619002|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
602660|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602661|NCT00992186|E1|Reported Event|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
602662|NCT00992264|B17|Baseline|Total|Total of all reporting groups
602663|NCT00992264|B16|Baseline|Randomization Arm: 16|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [no].
602664|NCT00992264|B15|Baseline|Randomization Arm: 15|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [no].
602665|NCT00992264|B14|Baseline|Randomization Arm: 14|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [no].
602666|NCT00992264|B13|Baseline|Randomization Arm: 13|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [no].
602667|NCT00992264|B12|Baseline|Randomization Arm: 12|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [yes].
602668|NCT00992264|B11|Baseline|Randomization Arm: 11|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [yes].
602669|NCT00992264|B10|Baseline|Randomization Arm: 10|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
602670|NCT00992264|B9|Baseline|Randomization Arm: 9|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [yes].
602671|NCT00992264|B8|Baseline|Randomization Arm: 8|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [no].
602672|NCT00992264|B7|Baseline|Randomization Arm: 7|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [no].
602673|NCT00992264|B6|Baseline|Randomization Arm: 6|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [no].
602705|NCT00992264|E2|Reported Event|Testimonials|"Testimonial or No Testimonial
Persons are randomized to receive a personally tailored testimonial or not."
602677|NCT00992264|B2|Baseline|Radndomization Arm: 2|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
602678|NCT00992264|B1|Baseline|Randomization Arm: 1|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [yes].
602679|NCT00992264|P16|Participant Flow|Randomization Arm 16|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [no]
602680|NCT00992264|P15|Participant Flow|Randomization Arm 15|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [no]
602681|NCT00992264|P14|Participant Flow|Randomization Arm 14|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [no]
602682|NCT00992264|P13|Participant Flow|Randomization Arm 13|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [no]
602683|NCT00992264|P12|Participant Flow|Randomization Arm 12|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [yes]
602684|NCT00992264|P11|Participant Flow|Randomization Arm 11|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [yes]
602685|NCT00992264|P10|Participant Flow|Randomization Arm 10|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [yes]
602686|NCT00992264|P9|Participant Flow|Randomization Arm 9|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [yes]
602687|NCT00992264|P8|Participant Flow|Randomization Arm 8|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [no]
602688|NCT00992264|P7|Participant Flow|Randomization Arm 7|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [no]
602822|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602689|NCT00992264|P6|Participant Flow|Randomization Arm 6|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [no]
602690|NCT00992264|P5|Participant Flow|Randomization Arm 5|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [no]
602691|NCT00992264|P4|Participant Flow|Randomization Arm 4|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [yes]
602692|NCT00992264|P3|Participant Flow|Randomization Arm 3|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [yes]
602693|NCT00992264|P2|Participant Flow|Randomization Arm 2|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [yes]
602694|NCT00992264|P1|Participant Flow|Randomization Arm 1|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [yes]
602695|NCT00992264|O4|Outcome|Proactive Emails|"Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.
Persons in the comparison group did not receive proactive email reminders."
602696|NCT00992264|O3|Outcome|Navigation: Dictated|"Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking.
Persons in the comparison group could freely navigate the website."
602697|NCT00992264|O2|Outcome|Testimonials|"Persons in the 'active' comparison group were randomized to receive a personally tailored testimonial.
Persons in the comparison group did not receive the testimonial content."
602698|NCT00992264|O1|Outcome|Message Tone: Prescriptive|"Persons in the 'active' comparison group received website content written in a prescriptive message tone.
Persons in the comparison group received content written in a motivational message tone."
602699|NCT00992264|O4|Outcome|Proactive Outreach|"Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.
Persons in the comparison group did not receive proactive email reminders."
602700|NCT00992264|O3|Outcome|Navigation: Dictated|"Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking.
Persons in the comparison group could freely navigate the website."
602701|NCT00992264|O2|Outcome|Testimonials|"Persons in the 'active' comparison group were randomized to receive a personally tailored testimonial.
Persons in the comparison group did not receive the testimonial content."
602702|NCT00992264|O1|Outcome|Message Tone: Prescriptive|"Persons in the 'active' comparison group received website content written in a prescriptive message tone.
Persons in the comparison group received content written in a motivational message tone."
602703|NCT00992264|E4|Reported Event|Proactive Outreach|"Email or No-Email communication
Persons are randomized to receive periodic email reminders to return to the intervention website or not."
602704|NCT00992264|E3|Reported Event|Navigation|"Dictated or Non-Dictated
Persons are randomly assigned to be able to freely navigate the website or to have their navigation of the website pre-determined based on their baseline readiness to quit smoking."
602706|NCT00992264|E1|Reported Event|Message Tone|"Prescriptive or Motivational
Persons are randomized to receive intervention content written in either a prescriptive or motivational tone."
602707|NCT00992394|B3|Baseline|Total|Total of all reporting groups
602708|NCT00992394|B2|Baseline|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602709|NCT00992394|B1|Baseline|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602710|NCT00992394|P2|Participant Flow|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602711|NCT00992394|P1|Participant Flow|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602712|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602713|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602714|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602715|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602716|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602717|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602718|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602719|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602720|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602721|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602722|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602723|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602724|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602725|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602726|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602727|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602728|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602729|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602730|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602731|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602732|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
608314|NCT01014624|E1|Reported Event|Prasugrel 10 mg/Daily|
602733|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602734|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602735|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602736|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602737|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602738|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602739|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602740|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602741|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602742|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602743|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
603812|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
602744|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602745|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602746|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602747|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602748|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602749|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602750|NCT00992394|E2|Reported Event|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
602751|NCT00992394|E1|Reported Event|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
602752|NCT00992407|B3|Baseline|Total|Total of all reporting groups
602753|NCT00992407|B2|Baseline|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602754|NCT00992407|B1|Baseline|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602755|NCT00992407|P2|Participant Flow|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602756|NCT00992407|P1|Participant Flow|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602757|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602758|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602759|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602760|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602761|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602801|NCT00992407|E2|Reported Event|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602762|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602763|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602764|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602765|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602766|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602767|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602768|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602769|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602770|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602771|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602772|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602773|NCT00992407|O2|Outcome|Risperidone Tablet|Risperidone tablets were administered orally as 0.5–10 mg daily up to Week 52.
602774|NCT00992407|O1|Outcome|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602775|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602776|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602777|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602778|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602780|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602781|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602782|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602783|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602784|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602785|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602786|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602787|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602788|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602789|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602790|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602791|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602792|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602793|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602794|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602795|NCT00992407|O2|Outcome|Risperidone Tablet|Risperidone tablet were administered orally as 0.5–10 mg daily up to Week 52.
602796|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602797|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602798|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602799|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
602800|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602802|NCT00992407|E1|Reported Event|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
602803|NCT00992433|B3|Baseline|Total|Total of all reporting groups
602804|NCT00992433|B2|Baseline|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602805|NCT00992433|B1|Baseline|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602806|NCT00992433|P2|Participant Flow|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602807|NCT00992433|P1|Participant Flow|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602808|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602809|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602810|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602811|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602812|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602813|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602814|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602815|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602816|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602817|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602818|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602819|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602820|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602821|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602823|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602824|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602825|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602826|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602827|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602828|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602829|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602830|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602831|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602832|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602833|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602834|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602835|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602836|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602837|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602838|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602839|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602840|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602841|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602842|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602843|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602844|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602845|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602846|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602847|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602848|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602849|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602850|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602851|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602852|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602853|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602854|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602855|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602856|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602857|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602858|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602859|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602860|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602861|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602862|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602863|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602864|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602865|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602866|NCT00992433|E2|Reported Event|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602867|NCT00992433|E1|Reported Event|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
602904|NCT00992589|P1|Participant Flow|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602905|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
603813|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
602868|NCT00992446|B1|Baseline|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.
Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT
Bortezomib: Given IV
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Melphalan: Given IV
Rituximab: Given IV
Vorinostat: Given PO"
602869|NCT00992446|P1|Participant Flow|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.
Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT
Bortezomib: Given IV
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Melphalan: Given IV
Rituximab: Given IV
Vorinostat: Given PO"
602870|NCT00992446|O1|Outcome|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.
Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT
Bortezomib: Given IV
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Melphalan: Given IV
Rituximab: Given IV
Vorinostat: Given PO"
602871|NCT00992446|O1|Outcome|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.
Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT
Bortezomib: Given IV
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Melphalan: Given IV
Rituximab: Given IV
Vorinostat: Given PO"
602872|NCT00992446|E1|Reported Event|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.
Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT
Bortezomib: Given IV
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Melphalan: Given IV
Rituximab: Given IV
Vorinostat: Given PO"
602873|NCT00992459|B3|Baseline|Total|Total of all reporting groups
602874|NCT00992459|B2|Baseline|Treatment Arm B|Patients randomized to receive HPN-100 + NaPBA placebo for 2 weeks (Treatment Period 1) followed by NaPBA + HPN-100 placebo for 2 weeks (Treatment Period 2)
602875|NCT00992459|B1|Baseline|Treatment Arm A|Patients randomized to receive NaPBA + HPN 100 placebo for 2 weeks (Treatment Period 1) followed by HPN-100 + NaPBA placebo for 2 weeks (Treatment Period 2)
602876|NCT00992459|P2|Participant Flow|Arm B|Subjects in Arm B were assigned to receive HPN-100 + NaPBA placebo for 2 weeks All patients in Arm B received NaPBA placebo (+ concomitant active HPN 100)
602877|NCT00992459|P1|Participant Flow|Arm A|Subjects in Arm A were assigned to receive NaPBA + HPN 100 placebo for 2 weeks All patients in Arm A received HPN100 placebo (+ concomitant active NaPBA)
602878|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
602879|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
602880|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
602881|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
602882|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
602883|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
602884|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
602885|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
602886|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
602887|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
602888|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
602889|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
602890|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
602891|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
602892|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
602893|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
602894|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
602895|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
602896|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
602897|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
602898|NCT00992459|E2|Reported Event|HPN-100|Patients received HPN-100
602899|NCT00992459|E1|Reported Event|NaPBA|Patients received NaPBA
602900|NCT00992589|B1|Baseline|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602901|NCT00992589|P4|Participant Flow|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602902|NCT00992589|P3|Participant Flow|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
602903|NCT00992589|P2|Participant Flow|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
602906|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602907|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
602908|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
602909|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
602910|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602911|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
602912|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
602913|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
602914|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602915|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
602916|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
602917|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
602918|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602919|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
602920|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
602921|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
602922|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602923|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
602924|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
602925|NCT00992589|O8|Outcome|Double-Blind Rabeprazole Sodium Total - Week 8|Rabeprazole Sodium capsules once daily in the morning.
602926|NCT00992589|O7|Outcome|Double-Blind Rabeprazole Sodium Total - Baseline|Rabeprazole Sodium capsules once daily in the morning.
602927|NCT00992589|O6|Outcome|Double-Blind Rabeprazole Sodium 10 mg - Week 8|Rabeprazole Sodium capsules once daily in the morning.
602928|NCT00992589|O5|Outcome|Double-Blind Rabeprazole Sodium 5 mg - Week 8|Rabeprazole Sodium capsules once daily in the morning.
602929|NCT00992589|O4|Outcome|Double-Blind Placebo - Week 8|Matching placebo capsules once daily in the morning.
602930|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg - Baseline|Rabeprazole Sodium capsules once daily in the morning.
602931|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg - Baseline|Rabeprazole Sodium capsules once daily in the morning.
602932|NCT00992589|O1|Outcome|Double-Blind Placebo - Baseline|Matching placebo capsules once daily in the morning.
602933|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
602934|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602935|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
602936|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
602937|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
602938|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602939|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
602940|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
602941|NCT00992589|E4|Reported Event|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602942|NCT00992589|E3|Reported Event|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
602943|NCT00992589|E2|Reported Event|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
602944|NCT00992589|E1|Reported Event|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
602945|NCT00992602|B1|Baseline|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.
Consolidation phase:
2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.
Maintenance phase:
Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)
Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
602946|NCT00992602|P1|Participant Flow|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.
Consolidation phase:
2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.
Maintenance phase:
Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)
Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
602947|NCT00992602|O1|Outcome|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.
Consolidation phase:
2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.
Maintenance phase:
Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)
Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
602984|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602985|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
619003|NCT01037244|O4|Outcome|Placebo|Placebo tablets
602948|NCT00992602|O1|Outcome|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.
Consolidation phase:
2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.
Maintenance phase:
Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)
Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
602949|NCT00992602|E1|Reported Event|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.
Consolidation phase:
2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.
Maintenance phase:
Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)
Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
602950|NCT00992719|B4|Baseline|Total|Total of all reporting groups
602951|NCT00992719|B3|Baseline|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602952|NCT00992719|B2|Baseline|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602953|NCT00992719|B1|Baseline|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602954|NCT00992719|P3|Participant Flow|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602955|NCT00992719|P2|Participant Flow|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602956|NCT00992719|P1|Participant Flow|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602957|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602958|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602959|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602960|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602961|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602962|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602963|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602964|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602965|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602966|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602967|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602968|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602969|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602970|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602971|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602972|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602973|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602974|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602975|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602976|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602977|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602978|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602979|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602980|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602981|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602982|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602983|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602986|NCT00992719|E3|Reported Event|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602987|NCT00992719|E2|Reported Event|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602988|NCT00992719|E1|Reported Event|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
602989|NCT00992784|B4|Baseline|Total|Total of all reporting groups
602990|NCT00992784|B3|Baseline|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
602991|NCT00992784|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
602992|NCT00992784|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
602993|NCT00992784|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
602994|NCT00992784|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
602995|NCT00992784|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
602996|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
602997|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
602998|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
602999|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603000|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603001|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603002|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603003|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603004|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603005|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603006|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603007|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603008|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603009|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603010|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603011|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603012|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603013|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603014|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603015|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603016|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603017|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603018|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603019|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603020|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603021|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603022|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603023|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603024|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603025|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603026|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603027|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603028|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603029|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603030|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603031|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603032|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603033|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603034|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603814|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
603035|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603036|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603037|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603038|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603039|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603040|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603041|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603042|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603043|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603044|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603045|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603046|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603047|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603048|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603049|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603050|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603051|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603052|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603053|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603054|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603055|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603056|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603057|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603058|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603059|NCT00992784|E3|Reported Event|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
603060|NCT00992784|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
603061|NCT00992784|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
603062|NCT00992836|B1|Baseline|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
603063|NCT00992836|P1|Participant Flow|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
603064|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 68, those who received the vaccinations and had enough samples for testing.
603065|NCT00992836|O1|Outcome|Influenza A (H1N1) 2009 Monovalent Vaccine|"All participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart.
Influenza A (H1N1) 2009 monovalent vaccine: Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections"
603066|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 68, those who received the vaccinations and had enough samples for testing.
603067|NCT00992836|O1|Outcome|Overall|The total N for these analyses were 140, 142 and 138, for the analysis of antibody titers after the first and second vaccinations and after 6 months after the second vaccination, respectively.
603068|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 138, those who received both vaccinations and had nonmissing data.
603069|NCT00992836|O1|Outcome|Overall|The total N for these analyses were 140 and 142, for the analysis of antibody titers after the first and second vaccinations, respectively.
603070|NCT00992836|O1|Outcome|Vaccinated Study Participants|The 154 study participants who received at last one vaccination are included in this analysis.
603071|NCT00992836|O1|Outcome|Vaccinated Study Participants|The 154 study participants who received at last one vaccination are included in this analysis.
603072|NCT00992836|O1|Outcome|All Study Participants|All 155 study participants are included in this analysis.
603073|NCT00992836|E1|Reported Event|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
603074|NCT00992927|B3|Baseline|Total|Total of all reporting groups
603075|NCT00992927|B2|Baseline|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
603076|NCT00992927|B1|Baseline|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
603077|NCT00992927|P2|Participant Flow|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
603078|NCT00992927|P1|Participant Flow|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
603120|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603079|NCT00992927|O2|Outcome|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
603080|NCT00992927|O1|Outcome|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
603081|NCT00992927|O2|Outcome|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
603082|NCT00992927|O1|Outcome|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
603083|NCT00992927|E2|Reported Event|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
603084|NCT00992927|E1|Reported Event|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
603085|NCT00992992|B1|Baseline|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603086|NCT00992992|P1|Participant Flow|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603087|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603133|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
604292|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
603088|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603089|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603090|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603091|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603121|NCT00993148|E1|Reported Event|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603122|NCT00993187|B3|Baseline|Total|Total of all reporting groups
603580|NCT00993824|B1|Baseline|Welchol Then Placebo|3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
603092|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603093|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603094|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603095|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603134|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
603096|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603097|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603098|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603099|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603123|NCT00993187|B2|Baseline|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
603124|NCT00993187|B1|Baseline|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
603100|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603101|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603102|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603103|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603104|NCT00992992|E1|Reported Event|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
603105|NCT00993044|B1|Baseline|Dose Level 1, 2|
603106|NCT00993044|P1|Participant Flow|Single Arm|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5
Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5
Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5
Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5
* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed"
603107|NCT00993044|O1|Outcome|Single Arm|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5
Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5
Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5
Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5
* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed"
603108|NCT00993044|E2|Reported Event|Dose Level 2|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5"
603109|NCT00993044|E1|Reported Event|Dose Level 1|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5"
603110|NCT00993148|B1|Baseline|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603111|NCT00993148|P1|Participant Flow|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603112|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603113|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603114|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603115|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603116|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603117|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603118|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603119|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
603125|NCT00993187|P2|Participant Flow|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
603126|NCT00993187|P1|Participant Flow|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
603127|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
603128|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
603129|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
603130|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
603131|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
603132|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
603193|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
603135|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
603136|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
603137|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
603138|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
603139|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
603140|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
603141|NCT00993187|E2|Reported Event|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
603142|NCT00993187|E1|Reported Event|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
603143|NCT00993200|B3|Baseline|Total|Total of all reporting groups
603144|NCT00993200|B2|Baseline|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
603145|NCT00993200|B1|Baseline|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
603146|NCT00993200|P2|Participant Flow|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
603147|NCT00993200|P1|Participant Flow|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
603148|NCT00993200|O2|Outcome|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
603149|NCT00993200|O1|Outcome|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
603150|NCT00993200|O2|Outcome|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
603151|NCT00993200|O1|Outcome|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
603152|NCT00993200|O2|Outcome|PERMIT|Warfarin management with use of gene-based warfarin dosing algorithm
603153|NCT00993200|O1|Outcome|Standard|Standard of care warfarin management
603154|NCT00993200|E2|Reported Event|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
603155|NCT00993200|E1|Reported Event|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
603156|NCT00993265|B3|Baseline|Total|Total of all reporting groups
603157|NCT00993265|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
603158|NCT00993265|B1|Baseline|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.
N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
603159|NCT00993265|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
603160|NCT00993265|P1|Participant Flow|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.
N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
603161|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
603162|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.
N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
603163|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
603164|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.
N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
603165|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
603166|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.
N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
603167|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
603168|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.
N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
603169|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
603170|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.
N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
603171|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
603172|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.
N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
603173|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
603578|NCT00993824|B3|Baseline|Total|Total of all reporting groups
603815|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
603174|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.
N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
603175|NCT00993265|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
603176|NCT00993265|E1|Reported Event|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.
N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
603177|NCT00993291|B1|Baseline|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
603178|NCT00993291|P1|Participant Flow|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
603179|NCT00993291|O1|Outcome|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
603180|NCT00993291|E1|Reported Event|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
603181|NCT00993317|B3|Baseline|Total|Total of all reporting groups
603182|NCT00993317|B2|Baseline|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
603183|NCT00993317|B1|Baseline|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
603184|NCT00993317|P2|Participant Flow|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
603185|NCT00993317|P1|Participant Flow|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
603186|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
603187|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
603188|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
603189|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
603190|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
603191|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
603192|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
603194|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
603195|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
603196|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
603197|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
603198|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
603199|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
603200|NCT00993317|E2|Reported Event|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
603201|NCT00993317|E1|Reported Event|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
603202|NCT00993421|B8|Baseline|Total|Total of all reporting groups
603203|NCT00993421|B7|Baseline|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603204|NCT00993421|B6|Baseline|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603205|NCT00993421|B5|Baseline|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603206|NCT00993421|B4|Baseline|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603207|NCT00993421|B3|Baseline|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603208|NCT00993421|B2|Baseline|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603209|NCT00993421|B1|Baseline|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603210|NCT00993421|P7|Participant Flow|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603211|NCT00993421|P6|Participant Flow|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603212|NCT00993421|P5|Participant Flow|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603213|NCT00993421|P4|Participant Flow|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603214|NCT00993421|P3|Participant Flow|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603215|NCT00993421|P2|Participant Flow|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603216|NCT00993421|P1|Participant Flow|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603217|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603218|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603219|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603220|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603221|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603222|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603223|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603224|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603225|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603226|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603227|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603228|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603229|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603230|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603231|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603232|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603233|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603234|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603235|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603236|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603237|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
619004|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
603238|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603239|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603240|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603241|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603242|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603243|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603244|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603245|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603246|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603247|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603248|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603249|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603250|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603251|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603252|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603253|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603254|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603255|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603256|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603257|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603258|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603259|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603260|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603261|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603262|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603263|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603264|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603265|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603266|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603816|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
603267|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603268|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603269|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603270|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603271|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603272|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603273|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603274|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603275|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603276|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603277|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603278|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603279|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603280|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603281|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603282|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603283|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603284|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603285|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603286|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603287|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603288|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603289|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603290|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603291|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603292|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603293|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603294|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603295|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603817|NCT01002287|E2|Reported Event|Control|Good Surgical Technique Alone
603296|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603297|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603298|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603299|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603300|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603301|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603302|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603303|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603304|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603305|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603306|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603307|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603308|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603309|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603310|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603311|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603312|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603313|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603314|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603315|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603316|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603317|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603318|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603319|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603320|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603321|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603322|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603323|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603324|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603943|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603325|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603326|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603327|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603328|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603329|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603330|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603331|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603332|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603333|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603334|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603335|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603336|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603337|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603338|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603339|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603370|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603340|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603341|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603342|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603343|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603344|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603345|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603346|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603347|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603348|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603349|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603350|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603351|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603352|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603353|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks."
603818|NCT01002287|E1|Reported Event|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
603354|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.
Placebo LY377604: given orally, daily for 24 weeks."
603355|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603356|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603357|NCT00993421|E7|Reported Event|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (15 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603358|NCT00993421|E6|Reported Event|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603359|NCT00993421|E5|Reported Event|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603360|NCT00993421|E4|Reported Event|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.
sibutramine (30 mg): Given orally, daily for 24 weeks.
Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
603361|NCT00993421|E3|Reported Event|Sibutramine (30mg)/Metoprolol (200mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.
metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day).
Placebo LY377604: given orally, daily for 24 weeks."
603362|NCT00993421|E2|Reported Event|LY377604 (75 mg)|Given orally, daily for 24 weeks.
603363|NCT00993421|E1|Reported Event|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.
Placebo sibutramine: given orally, daily for 24 weeks.
Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
603364|NCT00993447|B3|Baseline|Total|Total of all reporting groups
603365|NCT00993447|B2|Baseline|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603366|NCT00993447|B1|Baseline|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603367|NCT00993447|P2|Participant Flow|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603368|NCT00993447|P1|Participant Flow|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603369|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603371|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603372|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603373|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603374|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603375|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603376|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603377|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603378|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603379|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603380|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603381|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603382|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603383|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603384|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603385|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603819|NCT01002339|B4|Baseline|Total|Total of all reporting groups
603386|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603387|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603388|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603389|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603390|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603391|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603392|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603393|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603394|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603395|NCT00993447|E2|Reported Event|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
603396|NCT00993447|E1|Reported Event|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
603397|NCT00993473|B3|Baseline|Total|Total of all reporting groups
603398|NCT00993473|B2|Baseline|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603399|NCT00993473|B1|Baseline|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603400|NCT00993473|P2|Participant Flow|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603401|NCT00993473|P1|Participant Flow|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603402|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603786|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
603403|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603404|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603405|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603406|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603407|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603408|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603409|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603410|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603411|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603412|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603413|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603414|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603415|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603416|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603944|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603417|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603418|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603419|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603420|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603421|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603422|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603423|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603424|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603425|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603426|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603427|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603428|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603429|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603430|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603431|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
604293|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
603432|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603433|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.
Dose: titrated to achieve glycemic targets as described in protocol section."
603434|NCT00993473|E2|Reported Event|NPH Insulin|
603435|NCT00993473|E1|Reported Event|Lantus|
603436|NCT00993499|B7|Baseline|Total|Total of all reporting groups
603437|NCT00993499|B6|Baseline|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603438|NCT00993499|B5|Baseline|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603439|NCT00993499|B4|Baseline|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603440|NCT00993499|B3|Baseline|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603441|NCT00993499|B2|Baseline|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603442|NCT00993499|B1|Baseline|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603443|NCT00993499|P6|Participant Flow|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603444|NCT00993499|P5|Participant Flow|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603445|NCT00993499|P4|Participant Flow|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603446|NCT00993499|P3|Participant Flow|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603447|NCT00993499|P2|Participant Flow|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603448|NCT00993499|P1|Participant Flow|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603449|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603450|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603451|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603452|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603453|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603454|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603455|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603456|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603457|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603458|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603459|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603460|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603461|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603462|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603463|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603464|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603465|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603466|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603467|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603468|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603469|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603470|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603471|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603472|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603473|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603474|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603475|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603476|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603477|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603478|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603479|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603480|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603481|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603482|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
619005|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
603483|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603484|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603485|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603486|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603487|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603488|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603489|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603490|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603491|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603492|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603493|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603494|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603495|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603496|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603497|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603498|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603499|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603500|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603501|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603502|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603503|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603504|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603505|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603506|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603507|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603508|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603509|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603510|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603511|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603512|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603513|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603514|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603515|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
619006|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
603516|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603517|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603518|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603519|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603520|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603521|NCT00993499|E6|Reported Event|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
603522|NCT00993499|E5|Reported Event|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
603523|NCT00993499|E4|Reported Event|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
603524|NCT00993499|E3|Reported Event|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
603525|NCT00993499|E2|Reported Event|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
603526|NCT00993499|E1|Reported Event|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
603527|NCT00993616|B1|Baseline|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.
belinostat: Given IV
carboplatin: Given IV"
603528|NCT00993616|P1|Participant Flow|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.
belinostat: Given IV
carboplatin: Given IV"
603565|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
608315|NCT01014689|B3|Baseline|Total|Total of all reporting groups
603529|NCT00993616|O1|Outcome|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.
belinostat: Given IV
carboplatin: Given IV"
603530|NCT00993616|E1|Reported Event|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.
belinostat: Given IV
carboplatin: Given IV"
603531|NCT00993655|B4|Baseline|Total|Total of all reporting groups
603532|NCT00993655|B3|Baseline|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
603533|NCT00993655|B2|Baseline|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
603534|NCT00993655|B1|Baseline|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
603535|NCT00993655|P3|Participant Flow|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
603536|NCT00993655|P2|Participant Flow|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
603579|NCT00993824|B2|Baseline|Placebo Then Welchol|Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
603537|NCT00993655|P1|Participant Flow|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
603538|NCT00993655|O3|Outcome|IP Carboplatin + IV/IP Paclitaxel|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
603539|NCT00993655|O2|Outcome|IP Cisplatin + IV/IP Paclitaxel|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
603540|NCT00993655|O1|Outcome|IV Carboplatin + IV Paclitaxel|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
603541|NCT00993655|O3|Outcome|IP Carboplatin + IV/IP Paclitaxel|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
603542|NCT00993655|O2|Outcome|IP Cisplatin + IV/IP Paclitaxel|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
603543|NCT00993655|O1|Outcome|IV Carboplatin + IV Paclitaxel|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
603544|NCT00993655|O3|Outcome|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
603545|NCT00993655|O2|Outcome|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
603546|NCT00993655|O1|Outcome|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
603547|NCT00993655|E3|Reported Event|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
603548|NCT00993655|E2|Reported Event|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
603549|NCT00993655|E1|Reported Event|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
603550|NCT00993668|B3|Baseline|Total|Total of all reporting groups
603551|NCT00993668|B2|Baseline|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
603552|NCT00993668|B1|Baseline|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603553|NCT00993668|P2|Participant Flow|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
603554|NCT00993668|P1|Participant Flow|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603555|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
603556|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603557|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
603558|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603559|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
603560|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603561|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
603562|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603563|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
603564|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603566|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603567|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
603568|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603569|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
603570|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603571|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
603572|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603573|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
603574|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603575|NCT00993668|E3|Reported Event|Cimzia at Any Time|Certolizumab pegol (at any time) - Subjects randomized to receive Certolizumab pegol (CZP) during the single blind (SB) period will receive two subcutaneous (sc) injections of SB CZP 200 mg at Weeks 0, 2, and 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32). Subjects randomized to placebo during the SB period will receive two 0.9% saline sc injections at Week 0, Week 2, and Week 4, followed by two sc injections of OL CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
603576|NCT00993668|E2|Reported Event|Cimzia (Single Blind)|Certolizumab pegol - Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4
603577|NCT00993668|E1|Reported Event|Placebo (Single Blind)|Placebo - Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4
603581|NCT00993824|P2|Participant Flow|Placebo Then Welchol|Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
603582|NCT00993824|P1|Participant Flow|Welchol Then Placebo|3.75 grams of colesevelam HCl (Welchol) taken for 12 weeks at evening meal, and then crossover to placebo taken at evening meal fro 12 weeks.
603583|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.
colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)
placebo"
603584|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.
colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)
placebo"
603585|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.
colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)
placebo"
603586|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.
colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)
placebo"
603587|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.
colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)
placebo"
603588|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.
colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)
placebo"
603589|NCT00993824|O2|Outcome|Placebo Then Welchol|Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
603590|NCT00993824|O1|Outcome|Welchol Then Placebo|3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
603591|NCT00993824|E2|Reported Event|Placebo|Placebo taken at evening meal
603592|NCT00993824|E1|Reported Event|Welchol|3.75 grams of colesevelam HCl taken at evening meal
603593|NCT00993915|B1|Baseline|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
603594|NCT00993915|P1|Participant Flow|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
603595|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
603906|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
603596|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
603597|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
603598|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
603599|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
603600|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
603601|NCT00993915|E1|Reported Event|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
603602|NCT00993928|B3|Baseline|Total|Total of all reporting groups
603603|NCT00993928|B2|Baseline|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
603604|NCT00993928|B1|Baseline|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
603605|NCT00993928|P2|Participant Flow|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
603606|NCT00993928|P1|Participant Flow|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
603607|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
603608|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
619007|NCT01037244|O4|Outcome|Placebo|Placebo tablets
603609|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
603610|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
603611|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
603612|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
603613|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
603614|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
603615|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|"Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet."
603616|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|"Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet."
603617|NCT00993928|E2|Reported Event|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
603618|NCT00993928|E1|Reported Event|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
603619|NCT00993954|B3|Baseline|Total|Total of all reporting groups
603620|NCT00993954|B2|Baseline|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603907|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
603621|NCT00993954|B1|Baseline|Nurse Reduction|"Patients randomized to reduction by nurse.
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603622|NCT00993954|P2|Participant Flow|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603623|NCT00993954|P1|Participant Flow|Nurse Reduction|"Patients randomized to reduction by nurse.
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603624|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603625|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603626|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603627|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603628|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603629|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603630|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603631|NCT00993954|E2|Reported Event|Physician Reduction|"Patients randomized to reduction by physician
Physicians were free to use the reduction method of their choice"
603632|NCT00993954|E1|Reported Event|Nurse Reduction|"Patients randomized to reduction by nurse.
Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
603667|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily"
603633|NCT00999908|B1|Baseline|Entire Study Population|The entire study population includes the 3 groups of patients who received indacaterol 150 μg, tiotropium 18 μg, and placebo (matching indacaterol) once each in 1 of 3 different orders in this crossover study. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603634|NCT00999908|P3|Participant Flow|Placebo-indacaterol 150 μg-tiotropium 18 μg|Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603635|NCT00999908|P2|Participant Flow|Tiotropium 18 μg-placebo-indacaterol 150 μg|Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603636|NCT00999908|P1|Participant Flow|Indacaterol 150 μg-tiotropium 18 μg-placebo|Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603637|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603638|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603639|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603640|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603641|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603642|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
604047|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
603643|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603644|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603645|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603646|NCT00999908|E3|Reported Event|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603647|NCT00999908|E2|Reported Event|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603648|NCT00999908|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
603649|NCT00999921|B3|Baseline|Total|Total of all reporting groups
603650|NCT00999921|B2|Baseline|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg daily for 3 months
603651|NCT00999921|B1|Baseline|Tamoxifen|Tamoxifen was administered at a dose of 10 mg once daily ffrom 5th day to 25 th day of menstrual cycle for 3 months
603652|NCT00999921|P2|Participant Flow|Evening Primrose Oil|Evening Primrose Oil 1000 mg daily for 3 months
603653|NCT00999921|P1|Participant Flow|Tamoxifen|Tamoxifen 10 mg OD from 5th day to 25th day of menstrual cycle for 3 months
603654|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg once daily for 3 months
603655|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen was administered at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
603656|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg once daily for 3 months
603657|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen administered at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
603658|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
603659|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
603660|NCT00999921|E2|Reported Event|Evening Primrose Oil|Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
603661|NCT00999921|E1|Reported Event|Tamoxifen|Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
603662|NCT01000025|B3|Baseline|Total|Total of all reporting groups
603663|NCT01000025|B2|Baseline|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily"
603664|NCT01000025|B1|Baseline|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily"
603665|NCT01000025|P2|Participant Flow|Placebo|Control arm
603666|NCT01000025|P1|Participant Flow|PF-804|Study treatment arm
603668|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily"
603669|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily"
603670|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily"
603671|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily"
603672|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily"
603673|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily"
603674|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily"
603675|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily"
603676|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily"
603677|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily"
603678|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily"
603679|NCT01000025|E2|Reported Event|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily"
603680|NCT01000025|E1|Reported Event|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily"
603681|NCT01000064|B1|Baseline|All Participants|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.
Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.
Drug: Placebo Capsules taken for 42 days."
604294|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
603682|NCT01000064|P2|Participant Flow|Placebo First, Then Vyvanse|"Drug: Placebo Capsules taken for 42 days.
Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.
Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days."
603683|NCT01000064|P1|Participant Flow|Vyvanse First, Then Placebo|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.
Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.
Drug: Placebo Capsules taken for 42 days."
603684|NCT01000064|O2|Outcome|Placebo First, Then Vyvanse|"Drug: Placebo Capsules taken for 42 days.
Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.
Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days."
603685|NCT01000064|O1|Outcome|Vyvanse First, Then Placebo|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.
Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.
Drug: Placebo Capsules taken for 42 days."
603686|NCT01000064|O1|Outcome|All Participants|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.
Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.
Drug: Placebo Capsules taken for 42 days."
603687|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603688|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603689|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603690|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603691|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603692|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603693|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603694|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603695|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603696|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603697|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603698|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603699|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603700|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.
fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
603701|NCT01000064|E2|Reported Event|Placebo|Placebo capsule Taken for 42 days.
603702|NCT01000064|E1|Reported Event|Vyvanse|Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.
603703|NCT01000155|B1|Baseline|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
603704|NCT01000155|P1|Participant Flow|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
603705|NCT01000155|O1|Outcome|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
603706|NCT01000155|O1|Outcome|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
603707|NCT01000155|O1|Outcome|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
603784|NCT01002105|O2|Outcome|Placebo|IThe placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations
604048|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
603708|NCT01000155|E1|Reported Event|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
603709|NCT01001806|B4|Baseline|Total|Total of all reporting groups
603710|NCT01001806|B3|Baseline|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
603711|NCT01001806|B2|Baseline|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
603712|NCT01001806|B1|Baseline|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
603713|NCT01001806|P3|Participant Flow|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
603714|NCT01001806|P2|Participant Flow|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
603715|NCT01001806|P1|Participant Flow|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
603716|NCT01001806|O3|Outcome|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
603717|NCT01001806|O2|Outcome|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
603718|NCT01001806|O1|Outcome|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
603719|NCT01001806|E3|Reported Event|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
603720|NCT01001806|E2|Reported Event|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
603721|NCT01001806|E1|Reported Event|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
603722|NCT01001832|B3|Baseline|Total|Total of all reporting groups
603723|NCT01001832|B2|Baseline|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603724|NCT01001832|B1|Baseline|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603725|NCT01001832|P2|Participant Flow|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603726|NCT01001832|P1|Participant Flow|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603727|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603728|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603729|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603730|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603731|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603785|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
603732|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603733|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603734|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603735|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603736|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603737|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603738|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603739|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603740|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603806|NCT01002287|B1|Baseline|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
603807|NCT01002287|P2|Participant Flow|Control|Good Surgical Technique Alone
603741|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603742|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603743|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603744|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603745|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603746|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603747|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603748|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603749|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603750|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603751|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603752|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603753|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603754|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603808|NCT01002287|P1|Participant Flow|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
603809|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
603755|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603756|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603757|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603758|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603759|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603760|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603761|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603762|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Follow-up period was up to 168 days after the last dose of drug."
603763|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo)."
603764|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo)."
603765|NCT01001832|E3|Reported Event|Short Term Subcutaneous (SC) Abatacept, 125 mg|Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
603766|NCT01001832|E2|Reported Event|Short Term Intravenous (IV) Abatacept, 125 mg|Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
603767|NCT01001832|E1|Reported Event|Abatacept Long-term (LT) SC 125 mg|Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo). Follow-up was up to 168 days after the last dose of drug.
603768|NCT01001975|B3|Baseline|Total|Total of all reporting groups
603769|NCT01001975|B2|Baseline|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
603770|NCT01001975|B1|Baseline|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
603771|NCT01001975|P2|Participant Flow|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
603772|NCT01001975|P1|Participant Flow|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
603773|NCT01001975|O2|Outcome|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
603774|NCT01001975|O1|Outcome|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
603775|NCT01001975|O2|Outcome|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
603776|NCT01001975|O1|Outcome|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
603777|NCT01001975|E2|Reported Event|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
603778|NCT01001975|E1|Reported Event|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
603779|NCT01002105|B3|Baseline|Total|Total of all reporting groups
603780|NCT01002105|B2|Baseline|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
603781|NCT01002105|B1|Baseline|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks"
603782|NCT01002105|P2|Participant Flow|Placebo|Placebo, identical to baclofen was administered to the placebo group for 12 weeks
603783|NCT01002105|P1|Participant Flow|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks"
603787|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
603788|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
603789|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
603790|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
603791|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
603792|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
603793|NCT01002105|O1|Outcome|Baclofen|The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. Baclofen: Baclofen 50mg per day for 12 weeks
603794|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
603795|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks"
603796|NCT01002105|E2|Reported Event|Placebo|The placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
603797|NCT01002105|E1|Reported Event|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks"
603798|NCT01002118|B1|Baseline|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
603799|NCT01002118|P1|Participant Flow|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
603800|NCT01002118|O1|Outcome|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
603801|NCT01002118|O1|Outcome|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
603802|NCT01002118|O1|Outcome|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
603803|NCT01002118|E1|Reported Event|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
603804|NCT01002287|B3|Baseline|Total|Total of all reporting groups
603805|NCT01002287|B2|Baseline|Control|Good Surgical Technique Alone
603820|NCT01002339|B3|Baseline|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603821|NCT01002339|B2|Baseline|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603822|NCT01002339|B1|Baseline|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603823|NCT01002339|P3|Participant Flow|Cyclosporin A (CsA) With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603824|NCT01002339|P2|Participant Flow|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603825|NCT01002339|P1|Participant Flow|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603826|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603827|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603828|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603829|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603830|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603831|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603832|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603833|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603834|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603887|NCT01002456|E1|Reported Event|Level 1: Provide Site-specific Information|Level 1: provide site-specific information on non-adherence
603835|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603836|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603837|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603838|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603839|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603840|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603841|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603842|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603843|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603844|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603845|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603846|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603847|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603848|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603849|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603888|NCT01002482|B3|Baseline|Total|Total of all reporting groups
603945|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603850|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603851|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603852|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603853|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603854|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603855|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603856|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603857|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603858|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603859|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603860|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603861|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603862|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603863|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603864|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603889|NCT01002482|B2|Baseline|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
603865|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603866|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603867|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603868|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603869|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603870|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603871|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603872|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603873|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603874|NCT01002339|E3|Reported Event|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
603875|NCT01002339|E2|Reported Event|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
603876|NCT01002339|E1|Reported Event|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
603877|NCT01002456|B3|Baseline|Total|Total of all reporting groups
603878|NCT01002456|B2|Baseline|Level 2|site- and patient-specific information provided
603879|NCT01002456|B1|Baseline|Level 1|site-specific information provided
603880|NCT01002456|P2|Participant Flow|Arm 2|"provide site- and patient-specific information
Level 2 (Provide site- and patient-specific information): provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions"
603881|NCT01002456|P1|Participant Flow|Arm 1|"provide site-specific information
Level 1 (Provide site-specific information): provide site-specific information on non-adherence to guideline"
603882|NCT01002456|O2|Outcome|Level 2:Provide Site- and Patient-specific Information|Level 2:provide site- and patient-specific information on nonadherence
603883|NCT01002456|O1|Outcome|Level 1: Provide Site-specific Information|Level 1: provide site-specific information on nonadherence
603884|NCT01002456|O2|Outcome|Level 2|provide site- and patient-specific information
603885|NCT01002456|O1|Outcome|Level 1|provide site-specific information
603886|NCT01002456|E2|Reported Event|Level 2: Provide Site- and Patient-specific Information|Level 2: provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions
603941|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603890|NCT01002482|B1|Baseline|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
603891|NCT01002482|P2|Participant Flow|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
603892|NCT01002482|P1|Participant Flow|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
603893|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
603894|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
603895|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
603896|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
603897|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
603898|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
603899|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
603900|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
603901|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
603902|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
603903|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
603904|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
603905|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
604049|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
603908|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
603909|NCT01002482|E2|Reported Event|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
603910|NCT01002482|E1|Reported Event|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
603911|NCT01002573|B3|Baseline|Total|Total of all reporting groups
603912|NCT01002573|B2|Baseline|Acetaminophen|"Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg"
603913|NCT01002573|B1|Baseline|Ibuprofen|"Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg"
603914|NCT01002573|P2|Participant Flow|Acetaminophen|"Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg"
603915|NCT01002573|P1|Participant Flow|Ibuprofen|"Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg"
603916|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg"
603917|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg"
603918|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg"
603919|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg"
603920|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg"
603921|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg"
603922|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg"
603923|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg"
603924|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg"
603925|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg"
603926|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg"
603927|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg"
603928|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg"
603929|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg"
603930|NCT01002573|E2|Reported Event|Acetaminophen|"Acetaminophen, 10mg/kg
acetaminophen: Acetaminophen, 10mg/kg"
603931|NCT01002573|E1|Reported Event|Ibuprofen|"Ibuprofen, 10 mg/kg
ibuprofen: Ibuprofen, 10 mg/kg"
603932|NCT01002742|B3|Baseline|Total|Total of all reporting groups
603933|NCT01002742|B2|Baseline|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603934|NCT01002742|B1|Baseline|Placebo|Corticosteroids with placebo
603935|NCT01002742|P2|Participant Flow|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603936|NCT01002742|P1|Participant Flow|Placebo|Corticosteroids with placebo
603937|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603938|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603939|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603940|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603947|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603948|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603949|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603950|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603951|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603952|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603953|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603954|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603955|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603956|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603957|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603958|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603959|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603960|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603961|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603962|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603963|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603964|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603965|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603966|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
603967|NCT01002742|E2|Reported Event|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
603968|NCT01002742|E1|Reported Event|Placebo|Corticosteroids with placebo
603969|NCT01002989|B1|Baseline|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
603970|NCT01002989|P1|Participant Flow|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
603971|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
604295|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
603972|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
603973|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
603974|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
603975|NCT01002989|E1|Reported Event|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
603976|NCT01003067|B3|Baseline|Total|Total of all reporting groups
603977|NCT01003067|B2|Baseline|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
603978|NCT01003067|B1|Baseline|No Mesh|The closure technique consisted of a single-layer continuous suture technique with picking up all layers of the abdominal wall apart from subcutaneous fat and skin (peritoneum, posterior rectus sheath, rectus muscle and anterior rectus sheath).
603979|NCT01003067|P2|Participant Flow|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
603980|NCT01003067|P1|Participant Flow|No Mesh|conventional abdominal closure with a suture
603981|NCT01003067|O2|Outcome|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
603982|NCT01003067|O1|Outcome|No Mesh|conventional abdominal closure with a suture
603983|NCT01003067|E2|Reported Event|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
603984|NCT01003067|E1|Reported Event|No Mesh|conventional abdominal closure with a suture
603985|NCT01003080|B3|Baseline|Total|Total of all reporting groups
603986|NCT01003080|B2|Baseline|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
603987|NCT01003080|B1|Baseline|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
603988|NCT01003080|P2|Participant Flow|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
603989|NCT01003080|P1|Participant Flow|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
603990|NCT01003080|O2|Outcome|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
603991|NCT01003080|O1|Outcome|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
603992|NCT01003080|E2|Reported Event|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
603993|NCT01003080|E1|Reported Event|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
603994|NCT01003106|B5|Baseline|Total|Total of all reporting groups
603995|NCT01003106|B4|Baseline|CRVO- Ranibizumab 2.0mg Alone|"Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
CRVO- Ranibizumab 2.0 mg alone: Central retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone"
603996|NCT01003106|B3|Baseline|CRVO- Ranibizumab 0.5mg Alone|"Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation
CRVO -Ranibizumab 0.5mg alone: Central retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone"
603997|NCT01003106|B2|Baseline|BRVO- Ranibizumab 2.0mg Alone|"Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
BRVO- Ranibizumab 2.0 mg alone: Branch retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone"
603998|NCT01003106|B1|Baseline|BRVO- Ranibizumab 0.5mg Alone|"Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.
BRVO -Ranibizumab 0.5mg alone: Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone"
603999|NCT01003106|P8|Participant Flow|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients randomized to this group at month 6 will receive 0.5mg/2.0mg prn ranibizumab along with laser photocoagulation.
604000|NCT01003106|P7|Participant Flow|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
604001|NCT01003106|P6|Participant Flow|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to this group at baseline will receive ranibizumab 2.0mg alone for 6 months .
604002|NCT01003106|P5|Participant Flow|CRVO- Ranibizumab 0.5mg Alone|Central retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg at of ranibizumab alone for 6 months.
604003|NCT01003106|P4|Participant Flow|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) ranibizumab along with laser photocoagulation.
604004|NCT01003106|P3|Participant Flow|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata 0.5mg/2.0mg of ranibizumab without laser photocoagulation.
604005|NCT01003106|P2|Participant Flow|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group at baseline will receive 2.0mg of Ranibizumab alone for 6 months.
604006|NCT01003106|P1|Participant Flow|BRVO- Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg of ranibizumab alone for 6 months.
604007|NCT01003106|O4|Outcome|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients in this group will receive 0.5mg/2.0mg prn ranibizumab and laser photocoagulation.
604008|NCT01003106|O3|Outcome|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients in this group will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
604009|NCT01003106|O2|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients in this group will receive pro re nata (prn) ranibizumab and laser.
604010|NCT01003106|O1|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients in this group will receive pro re nata 0.5mg/2.0mg of ranibizumab along without laser photocoagulation.
604011|NCT01003106|O4|Outcome|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
604012|NCT01003106|O3|Outcome|CRVO- Ranibizumab 0.5mg Alone|Patients randomized to receive 0.5mg of ranibizumab alone
604013|NCT01003106|O2|Outcome|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone.
604014|NCT01003106|O1|Outcome|BRVO-Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone.
604015|NCT01003106|O4|Outcome|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients in this group will receive 0.5mg/2.0mg prn ranibizumab and laser photocoagulation.
604016|NCT01003106|O3|Outcome|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients in this group will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
604017|NCT01003106|O2|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients in this group will receive pro re nata (prn) ranibizumab and laser.
604018|NCT01003106|O1|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients in this group will receive pro re nata 0.5mg/2.0mg of ranibizumab along without laser photocoagulation.
604019|NCT01003106|O4|Outcome|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
604020|NCT01003106|O3|Outcome|CRVO- Ranibizumab 0.5mg Alone|Patients randomized to receive 0.5mg of ranibizumab alone
604021|NCT01003106|O2|Outcome|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone.
604022|NCT01003106|O1|Outcome|BRVO-Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone.
604023|NCT01003106|O2|Outcome|CRVO|Patients with Central Retinal Vein Occlusion
604024|NCT01003106|O1|Outcome|BRVO|Patients with Branch Retinal Vein Occlusion
604025|NCT01003106|E2|Reported Event|CRVO|Patients with Central Retinal Vein Occlusion
604026|NCT01003106|E1|Reported Event|BRVO|Patients with Branch Retinal Vein Occlusion
604027|NCT01003184|B3|Baseline|Total|Total of all reporting groups
604028|NCT01003184|B2|Baseline|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604029|NCT01003184|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604030|NCT01003184|P2|Participant Flow|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604031|NCT01003184|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604032|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604033|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604034|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604035|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604036|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604037|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604038|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604039|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604040|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604041|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604042|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604043|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604044|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604045|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604046|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604298|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604050|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604051|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604052|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604053|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604054|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604055|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604056|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604057|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604058|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604059|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604060|NCT01003184|E2|Reported Event|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
604061|NCT01003184|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
604062|NCT01003210|B3|Baseline|Total|Total of all reporting groups
604063|NCT01003210|B2|Baseline|Standard Therapy|standard therapy for otitis media, no ear drops
604064|NCT01003210|B1|Baseline|Homeopathic Ear Drops|"Commercially available homeopathic ear drops
Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
604065|NCT01003210|P2|Participant Flow|Standard Therapy|standard therapy for otitis media, no ear drops
604066|NCT01003210|P1|Participant Flow|Homeopathic Ear Drops|"Commercially available homeopathic ear drops
Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
604067|NCT01003210|O2|Outcome|Standard Therapy|standard therapy for otitis media, no ear drops
604068|NCT01003210|O1|Outcome|Homeopathic Ear Drops|"Commercially available homeopathic ear drops
Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
604069|NCT01003210|O2|Outcome|Standard Therapy|standard therapy for otitis media, no ear drops
604070|NCT01003210|O1|Outcome|Homeopathic Ear Drops|"Commercially available homeopathic ear drops
Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
604071|NCT01003210|E2|Reported Event|Standard Therapy|standard therapy for otitis media, no ear drops
619008|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
604072|NCT01003210|E1|Reported Event|Homeopathic Ear Drops|"Commercially available homeopathic ear drops
Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
604073|NCT01003275|B3|Baseline|Total|Total of all reporting groups
604074|NCT01003275|B2|Baseline|Placebo Followed by Paricalcitol|Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
604075|NCT01003275|B1|Baseline|Paricalcitol Followed by Placebo|Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
604076|NCT01003275|P2|Participant Flow|Placebo Followed by Paricalcitol|Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
604077|NCT01003275|P1|Participant Flow|Paricalcitol Followed by Placebo|Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
604078|NCT01003275|O2|Outcome|During Placebo Treatment|
604079|NCT01003275|O1|Outcome|During Paricalcitol Treatment|
604080|NCT01003275|E2|Reported Event|During/After Placebo|
604081|NCT01003275|E1|Reported Event|During/After Paricalcitol|
604082|NCT01003288|B3|Baseline|Total|Total of all reporting groups
604083|NCT01003288|B2|Baseline|Hypogammaglobulinaemic Patients|Received two doses of pandemic vaccine
604084|NCT01003288|B1|Baseline|Health Care Workers|Received one or two doses of pandemic vaccine during 2009 pandemic and susbequent seasonal vaccination was optional
604085|NCT01003288|P1|Participant Flow|Pandemic Influenza Vaccine (H1N1)v|"Pandemrix: Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A)
* Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)"
604086|NCT01003288|O1|Outcome|HCW Pandemic Vaccine|
604087|NCT01003288|O1|Outcome|Pandemic Vaccine|Pandemic Vaccine in HCW
604088|NCT01003288|E1|Reported Event|Pandemic Vaccine|HCW vaccinated with pandemic vaccine
604089|NCT01003301|B3|Baseline|Total|Total of all reporting groups
604090|NCT01003301|B2|Baseline|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.
Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
604091|NCT01003301|B1|Baseline|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.
Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
604118|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
604296|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604092|NCT01003301|P2|Participant Flow|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.
Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
604093|NCT01003301|P1|Participant Flow|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.
Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
604094|NCT01003301|O2|Outcome|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.
Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
604095|NCT01003301|O1|Outcome|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.
Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
604096|NCT01003301|E2|Reported Event|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.
Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
604097|NCT01003301|E1|Reported Event|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.
Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
604098|NCT01003886|B1|Baseline|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
604099|NCT01003886|P1|Participant Flow|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
604100|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
604101|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
604102|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
604103|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
606211|NCT01006603|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
604104|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
604105|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
604106|NCT01003886|E1|Reported Event|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
604107|NCT01003899|B1|Baseline|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
604108|NCT01003899|P1|Participant Flow|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
604109|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
604110|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
604111|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
604112|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
604113|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
604114|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
604115|NCT01003899|E1|Reported Event|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
604116|NCT01003938|B1|Baseline|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
604117|NCT01003938|P1|Participant Flow|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
604297|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604119|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
604120|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
604121|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
604122|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
604123|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
604124|NCT01003938|E1|Reported Event|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
604125|NCT01003990|B4|Baseline|Total|Total of all reporting groups
604126|NCT01003990|B3|Baseline|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).
Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
604127|NCT01003990|B2|Baseline|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.
Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
604128|NCT01003990|B1|Baseline|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
604129|NCT01003990|P3|Participant Flow|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).
Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
604130|NCT01003990|P2|Participant Flow|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.
Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
604131|NCT01003990|P1|Participant Flow|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
604132|NCT01003990|O3|Outcome|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).
Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
604270|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604133|NCT01003990|O2|Outcome|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.
Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
604134|NCT01003990|O1|Outcome|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
604135|NCT01003990|E3|Reported Event|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).
Lopinavir: 400 mg BID; Ritonavir: 100 mg BID; Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
604136|NCT01003990|E2|Reported Event|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.
Ritonavir: 100 mg QD; Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
604137|NCT01003990|E1|Reported Event|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
604138|NCT01004003|B10|Baseline|Total|Total of all reporting groups
604139|NCT01004003|B9|Baseline|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604140|NCT01004003|B8|Baseline|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604141|NCT01004003|B7|Baseline|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604142|NCT01004003|B6|Baseline|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604143|NCT01004003|B5|Baseline|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604144|NCT01004003|B4|Baseline|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604145|NCT01004003|B3|Baseline|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604146|NCT01004003|B2|Baseline|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604147|NCT01004003|B1|Baseline|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN).
604148|NCT01004003|P9|Participant Flow|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604149|NCT01004003|P8|Participant Flow|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604150|NCT01004003|P7|Participant Flow|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604151|NCT01004003|P6|Participant Flow|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604152|NCT01004003|P5|Participant Flow|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604153|NCT01004003|P4|Participant Flow|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604154|NCT01004003|P3|Participant Flow|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
619009|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
604155|NCT01004003|P2|Participant Flow|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604156|NCT01004003|P1|Participant Flow|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN).
604157|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604158|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604159|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604160|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604161|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604162|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604163|NCT01004003|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
604164|NCT01004003|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
604165|NCT01004003|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
604166|NCT01004003|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
604167|NCT01004003|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)."
604168|NCT01004003|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)."
604169|NCT01004003|O1|Outcome|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD).
Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN)."
604170|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604171|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604172|NCT01004003|O2|Outcome|Group 2|Patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604173|NCT01004003|O1|Outcome|Group 1|Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)
604196|NCT01004159|E1|Reported Event|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
604174|NCT01004003|E9|Reported Event|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604175|NCT01004003|E8|Reported Event|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604176|NCT01004003|E7|Reported Event|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604177|NCT01004003|E6|Reported Event|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604178|NCT01004003|E5|Reported Event|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604179|NCT01004003|E4|Reported Event|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
604180|NCT01004003|E3|Reported Event|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604181|NCT01004003|E2|Reported Event|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
604182|NCT01004003|E1|Reported Event|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN).
604183|NCT01004146|B3|Baseline|Total|Total of all reporting groups
604184|NCT01004146|B2|Baseline|Experimental Group|Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
604185|NCT01004146|B1|Baseline|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.
604186|NCT01004146|P2|Participant Flow|Experimental Group|Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
604187|NCT01004146|P1|Participant Flow|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.
604188|NCT01004146|O2|Outcome|Experimental Group|Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
604189|NCT01004146|O1|Outcome|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.
604190|NCT01004146|E2|Reported Event|Experimental Group|Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
604191|NCT01004146|E1|Reported Event|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.
604192|NCT01004159|B1|Baseline|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
604193|NCT01004159|P1|Participant Flow|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
604194|NCT01004159|O1|Outcome|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
604195|NCT01004159|O1|Outcome|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
604237|NCT00991081|B3|Baseline|Total|Total of all reporting groups
604197|NCT01004172|B1|Baseline|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.
carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only
*8mg/kg loading dose in cycle 1 for some participants"
604198|NCT01004172|P1|Participant Flow|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.
carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only
*8mg/kg loading dose in cycle 1 for some participants"
604199|NCT01004172|O1|Outcome|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.
carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only
*8mg/kg loading dose in cycle 1"
604200|NCT01004172|O1|Outcome|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.
carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only
*8mg/kg loading dose in cycle 1 for some participants"
604201|NCT01004172|O1|Outcome|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.
carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only
*8mg/kg loading dose in cycle 1 for some participants"
604202|NCT01004172|E1|Reported Event|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.
carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only
*8mg/kg loading dose in cycle 1 for some participants"
604203|NCT01004185|B3|Baseline|Total|Total of all reporting groups
604204|NCT01004185|B2|Baseline|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
611626|NCT01019928|O1|Outcome|AZD1386 95 mg|
604205|NCT01004185|B1|Baseline|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
604206|NCT01004185|P2|Participant Flow|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
604207|NCT01004185|P1|Participant Flow|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
604208|NCT01004185|O2|Outcome|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
604209|NCT01004185|O1|Outcome|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
604210|NCT01004185|O2|Outcome|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
604211|NCT01004185|O1|Outcome|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
604212|NCT01004185|E2|Reported Event|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
604213|NCT01004185|E1|Reported Event|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
604214|NCT01004250|B1|Baseline|Study Treatment|"Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
604215|NCT01004250|P1|Participant Flow|Study Treatment|"Induction Therapy:
Bevacizumab: 7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 milligram per square meter (mg/m²) given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle (cycle=21 days) and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
604216|NCT01004250|O1|Outcome|Study Treament|"Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
604217|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles."
604218|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
604219|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
604220|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
604221|NCT01004250|E3|Reported Event|Overall Study Treatment|"Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
604222|NCT01004250|E2|Reported Event|Maintenance Therapy|"Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
604223|NCT01004250|E1|Reported Event|Induction Therapy|"Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles."
604250|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604224|NCT01004263|B1|Baseline|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
604225|NCT01004263|P1|Participant Flow|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
604226|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
604227|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
604228|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
604229|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
604230|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
604231|NCT01004263|E1|Reported Event|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
604232|NCT00990964|B1|Baseline|Attain Family Lead|Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
604233|NCT00990964|P1|Participant Flow|Attain Family Left Heart Lead|Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
604234|NCT00990964|O1|Outcome|Attain Family Lead Attempt, Any Catheter|Subjects who were attempted with Attain Family delivery catheters or Attain Family left-heart leads were included in this analysis.
604235|NCT00990964|O1|Outcome|Attain Family Lead and Catheter Attempt|Subjects who were attempted with an Attain Family left-heart lead after successful coronary sinus (CS) cannulation with an Attain Family catheter were included in this analysis as well as subjects who had unsuccessful CS cannulation with an Attain Family delivery catheter.
604236|NCT00990964|E1|Reported Event|Attain Family Lead|All new and/or worsening adverse events related to the left-heart leads and left-heart lead delivery catheters were collected through the 3 month visit. Event collection started once the subject enrolled in the study and underwent a left-heart lead implant attempt.
604238|NCT00991081|B2|Baseline|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
604239|NCT00991081|B1|Baseline|Standard Treatment|Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
604240|NCT00991081|P3|Participant Flow|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
604241|NCT00991081|P2|Participant Flow|Standard Treatment|Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
604242|NCT00991081|P1|Participant Flow|Formative Interviews|"Phase 1 involved formative research to develop and refine a patient-centered, theoretically grounded behavioral intervention for delivering genetically-tailored smoking cessation treatment. We convened a panel of doctorate level experts (n = 10) in pharmacogenetics; smoking cessation treatment; ethical, legal and social implications of genetics research; genetic literacy; patient-clinician communications; and mixed-methods research to guide development of the pharmacogenetic treatment, GF and evaluation.
Next, smokers were asked about their familiarity with genetic concepts (e.g., DNA, genes), understanding of the roles genes play in smoking behavior and treatment response, reaction to the concept of genetically-tailoring pharmacotherapy, familiarity with the Genetic Information Nondiscrimination Act, concerns about privacy of genetic information, and interest in genetically-tailored treatment. Interviews were continued until response saturation was achieved (n = 10)."
604243|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604244|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604245|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604246|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604247|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604248|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604249|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
611627|NCT01019928|O2|Outcome|Placebo|
604251|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604252|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604253|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604254|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604255|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604256|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604257|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604258|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604259|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604260|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604261|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604262|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604263|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604264|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604265|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604266|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604267|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604268|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604269|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
619010|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
604271|NCT00991081|E2|Reported Event|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604272|NCT00991081|E1|Reported Event|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
604273|NCT00991185|B1|Baseline|Vancomycin|children that received vancomycin per standard of care
604274|NCT00991185|P1|Participant Flow|Vancomycin|children that received vancomycin per standard of care
604275|NCT00991185|O1|Outcome|Vancomycin|children that received vancomycin per standard of care
604276|NCT00991185|E1|Reported Event|Vancomycin|children that received vancomycin per standard of care
604277|NCT00991276|B7|Baseline|Total|Total of all reporting groups
604278|NCT00991276|B6|Baseline|Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604279|NCT00991276|B5|Baseline|Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604280|NCT00991276|B4|Baseline|Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604291|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604281|NCT00991276|B3|Baseline|Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604282|NCT00991276|B2|Baseline|Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604283|NCT00991276|B1|Baseline|Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg|Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604284|NCT00991276|P6|Participant Flow|Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604285|NCT00991276|P5|Participant Flow|Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604322|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604286|NCT00991276|P4|Participant Flow|Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604287|NCT00991276|P3|Participant Flow|Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604288|NCT00991276|P2|Participant Flow|Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604289|NCT00991276|P1|Participant Flow|Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg|Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
604290|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604299|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604300|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604301|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604302|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604303|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604304|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604305|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily in any intervention period.
604306|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604307|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604308|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604309|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604310|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604311|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604312|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604313|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604314|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604315|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604316|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604317|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604318|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604319|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604320|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604321|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
619011|NCT01037244|O4|Outcome|Placebo|Placebo tablets
604323|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604324|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604325|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604326|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604327|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604328|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604329|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604330|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604331|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604332|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604333|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604334|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604335|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604336|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604337|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604338|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604339|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604340|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604341|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604342|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604343|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604344|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604345|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604346|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604347|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604348|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604349|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604350|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604351|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604352|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604353|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604354|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604355|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
611628|NCT01019928|O1|Outcome|AZD1386 95 mg|
604356|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604357|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604358|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604359|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604360|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604361|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604362|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604363|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604364|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604365|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604366|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604367|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604368|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604369|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604370|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604371|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604372|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604373|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604374|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604375|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604376|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604377|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604378|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604379|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604380|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
604381|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604382|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604383|NCT00991276|E3|Reported Event|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in any of the intervention period.
604384|NCT00991276|E2|Reported Event|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
604385|NCT00991276|E1|Reported Event|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
604386|NCT00991289|B1|Baseline|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604387|NCT00991289|P1|Participant Flow|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604388|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604389|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604390|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604391|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604392|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604393|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604394|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604468|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
611629|NCT01019928|O2|Outcome|Placebo|
604395|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604396|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604397|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604398|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604399|NCT00991289|E1|Reported Event|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
604400|NCT00991302|B3|Baseline|Total|Total of all reporting groups
604401|NCT00991302|B2|Baseline|Standard Care|Participants received standard care.
604402|NCT00991302|B1|Baseline|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.
Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
604403|NCT00991302|P2|Participant Flow|Standard Care|Participants received standard care.
604404|NCT00991302|P1|Participant Flow|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.
Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
604405|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
604406|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.
Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
604407|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
606213|NCT01006603|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
604408|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.
Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
604409|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
604410|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.
Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
604411|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
604412|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.
Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
604413|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
604414|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.
Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
604415|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
604416|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.
Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
604417|NCT00991302|E2|Reported Event|Standard Care|Participants received standard care.
604418|NCT00991302|E1|Reported Event|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.
Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
604419|NCT00991341|B3|Baseline|Total|Total of all reporting groups
604420|NCT00991341|B2|Baseline|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604421|NCT00991341|B1|Baseline|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604422|NCT00991341|P2|Participant Flow|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
605416|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
604423|NCT00991341|P1|Participant Flow|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604424|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604425|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604426|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604427|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604428|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604429|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604430|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604431|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604432|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
605444|NCT01004614|E2|Reported Event|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
604433|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604434|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604435|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604436|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604437|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604438|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604439|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604440|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604441|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604442|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604443|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
605731|NCT01005251|E4|Reported Event|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
604444|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604445|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604446|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604447|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604448|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604449|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604450|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604451|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604452|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604453|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
605125|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604454|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604455|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604456|NCT00991341|E2|Reported Event|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days
Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604457|NCT00991341|E1|Reported Event|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days
Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
604458|NCT00991458|B4|Baseline|Total|Total of all reporting groups
604459|NCT00991458|B3|Baseline|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604460|NCT00991458|B2|Baseline|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604461|NCT00991458|B1|Baseline|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604462|NCT00991458|P3|Participant Flow|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604463|NCT00991458|P2|Participant Flow|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604464|NCT00991458|P1|Participant Flow|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604465|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604466|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604467|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604469|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604470|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604471|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604472|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604473|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604474|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604475|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604476|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604477|NCT00991458|E3|Reported Event|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604478|NCT00991458|E2|Reported Event|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604479|NCT00991458|E1|Reported Event|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
604480|NCT00991510|B3|Baseline|Total|Total of all reporting groups
604481|NCT00991510|B2|Baseline|Test/Reference/Reference|"The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
605445|NCT01004614|E1|Reported Event|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
604482|NCT00991510|B1|Baseline|Reference/Test/Test|"The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
604483|NCT00991510|P2|Participant Flow|Test/Reference/Reference|"The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
604484|NCT00991510|P1|Participant Flow|Reference/Test/Test|"The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).
Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
604485|NCT00991510|O3|Outcome|Overall|Participant experience overall, i.e. all treatment experiences while on study are included
604486|NCT00991510|O2|Outcome|Myfenax|Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604487|NCT00991510|O1|Outcome|CellCept|Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604488|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604489|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604490|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604491|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604492|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604493|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604494|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604495|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604496|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
605732|NCT01005251|E3|Reported Event|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
604497|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604498|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604499|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604500|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604501|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604502|NCT00991510|E3|Reported Event|Overall|Participant experience overall, i.e. all treatment experiences while on study are included
604503|NCT00991510|E2|Reported Event|Myfenax|Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604504|NCT00991510|E1|Reported Event|CellCept|Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
604505|NCT00996892|B1|Baseline|All Participants|All participants who received cobimetinib and pictilisib in any dose combination until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604506|NCT00996892|P20|Participant Flow|S2A Expansion: 125 mg Cobimetinib + 180 mg Pictilisib|Stage 2A (S2A) expansion cohort: Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with KRAS mutant NSCLC; EGFR T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; KRAS mutant CRC, and KRAS mutant endometrioid carcinoma.
604507|NCT00996892|P19|Participant Flow|S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Stage 2 (S2) expansion cohort: Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant non–small cell lung cancer (NSCLC); epidermal growth factor receptor (EGFR) T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; and KRAS mutant colorectal cancer (CRC).
605126|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604508|NCT00996892|P18|Participant Flow|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Stage 1B Cohort DX (S1B CDX): Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604509|NCT00996892|P17|Participant Flow|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Stage 1B Cohort CX (S1B CCX): Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604510|NCT00996892|P16|Participant Flow|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Stage 1B Cohort BX (S1B CBX): Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604511|NCT00996892|P15|Participant Flow|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Stage 1B Cohort AX (S1B CAX): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604512|NCT00996892|P14|Participant Flow|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Stage 1A Cohort G (S1A CG): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604513|NCT00996892|P13|Participant Flow|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort F (S1A CF): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604514|NCT00996892|P12|Participant Flow|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Stage 1A Cohort E (S1A CE): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604515|NCT00996892|P11|Participant Flow|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort D (S1A CD): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605146|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604516|NCT00996892|P10|Participant Flow|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Stage 1A Cohort C (S1A CC): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604517|NCT00996892|P9|Participant Flow|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort B (S1A CB): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604518|NCT00996892|P8|Participant Flow|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Stage 1A Cohort A (S1A CA): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604519|NCT00996892|P7|Participant Flow|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 6A (S1 C6A): Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604520|NCT00996892|P6|Participant Flow|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 6 (S1 C6): Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604521|NCT00996892|P5|Participant Flow|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Stage 1 Cohort 5 (S1 C5): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604522|NCT00996892|P4|Participant Flow|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 4 (S1 C4): Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604523|NCT00996892|P3|Participant Flow|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Stage 1 Cohort 3 (S1 C3): Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605446|NCT01004705|B1|Baseline|Randomized Patients|All patients randomized to both study sequences (Combination Pill then Simvastatin and Simvastatin then Combination Pill)
604524|NCT00996892|P2|Participant Flow|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 2 (S1 C2): Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604525|NCT00996892|P1|Participant Flow|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Stage 1 Cohort 1 (S1 C1): Participants received a single oral dose of pictilisib 80 milligrams (mg) capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604526|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604527|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604528|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604529|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604530|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604531|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604532|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604533|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
604534|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604535|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604536|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604537|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604538|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604539|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605127|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604540|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
604541|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604542|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604543|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604544|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604545|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605417|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
604546|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604547|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604548|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604549|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604550|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604551|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
604552|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604553|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604554|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605128|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604555|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604556|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604557|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604558|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
604559|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604560|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604591|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604561|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604562|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604563|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604564|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604565|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604566|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604567|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604568|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604569|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
604570|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604571|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604572|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604573|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604574|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604575|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604576|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
604592|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605418|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
604577|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604578|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604579|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604580|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604581|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604582|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604583|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604584|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604585|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605088|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604586|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604587|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604588|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604589|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604590|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605419|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
604593|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604594|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604595|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604596|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604597|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604598|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604599|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604600|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604601|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604602|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604603|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604604|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604605|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604606|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604607|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604608|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604609|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604610|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604611|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604612|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604613|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604614|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604615|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604616|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604617|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604618|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604619|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604620|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604621|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604622|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604623|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604624|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604625|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604626|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604627|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604628|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604629|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604630|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604631|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604632|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604633|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604634|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604635|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604636|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604637|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604638|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604639|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604640|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604641|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604642|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604643|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604644|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604645|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604646|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604647|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604648|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604649|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604650|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604651|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604652|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604653|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604654|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604655|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604656|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604657|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604658|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604659|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604660|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604661|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604662|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604663|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604664|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604665|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604666|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604667|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604668|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604669|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604670|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604671|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604672|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604673|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604674|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604675|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604676|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604677|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605147|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604678|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604679|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604680|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604681|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604682|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604683|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604684|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604685|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604686|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604687|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604688|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605483|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
604689|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604690|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604691|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604692|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604693|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604694|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604695|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604696|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604697|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604698|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604699|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604700|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604701|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604702|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604703|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604704|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604705|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604706|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
606952|NCT01001104|P2|Participant Flow|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
604707|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604708|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604709|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604710|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604711|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604712|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604713|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604714|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604715|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604716|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604717|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604718|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604719|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604720|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604721|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604722|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604723|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604724|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
606016|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
604725|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604726|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604727|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604728|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604729|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604730|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604731|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604732|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604733|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604734|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604735|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604736|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604737|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604738|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604739|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604740|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604741|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604742|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
619012|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
604743|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604744|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604745|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604746|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604747|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604748|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605148|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604749|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604750|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604751|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604752|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604753|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604754|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604755|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604756|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604757|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604758|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604759|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605129|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604760|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604761|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604762|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604763|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604764|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604765|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604766|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604767|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604768|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604769|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604770|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604771|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604772|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604773|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604774|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604775|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604776|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605130|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604777|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604778|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604779|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604780|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604781|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604782|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604783|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604784|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604785|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604786|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604787|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604788|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604789|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604790|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604791|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604792|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604793|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605131|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604794|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604795|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604796|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604797|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604798|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604799|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604800|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604801|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604802|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604803|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604804|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604805|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604806|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604807|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604808|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604809|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604810|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604811|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604812|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604813|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604814|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604815|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604816|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604817|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605733|NCT01005251|E2|Reported Event|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
604818|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604819|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604820|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604821|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604822|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604823|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604824|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604825|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604826|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604827|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604828|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604829|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605311|NCT00997204|P1|Participant Flow|Naive Subjects/ Naive Treatment Phase|Patients who had never received icatibant before this phase, got treatment of Acute HAE Attack with SC icatibant (30 mg)Administered at Site by Health Care Provider.
604830|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604831|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604832|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604833|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604834|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604835|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604836|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604837|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604838|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604839|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604840|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604841|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604842|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604843|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604844|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604845|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604846|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604847|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605312|NCT00997204|O3|Outcome|Subjects Who Self-administered Icatibant (Non-naive)|Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
604848|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604849|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604850|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604851|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604852|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604853|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604854|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604855|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604856|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604857|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604858|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604859|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604860|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604861|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604862|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604863|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604864|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604865|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605313|NCT00997204|O2|Outcome|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
604866|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604867|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604868|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604869|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604870|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604871|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604872|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604873|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604874|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604875|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604876|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604877|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604878|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604879|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604880|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604881|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604882|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604883|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605314|NCT00997204|O1|Outcome|Naive Subjects Administered Icatibant by Health Care Provider|The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
604884|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604885|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604886|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604887|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604888|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604889|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604890|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604891|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604892|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604893|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604894|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604895|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604896|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604897|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604898|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604899|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604900|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604901|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605315|NCT00997204|O3|Outcome|Subjects Who Self-administered Icatibant (Non-naive)|Non-Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
604902|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604903|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604904|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604905|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604906|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604907|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604908|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604909|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604910|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604911|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604912|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604913|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604914|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604915|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604916|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604917|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604918|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604919|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605316|NCT00997204|O2|Outcome|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
604920|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604921|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604922|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604923|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604924|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604925|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604926|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604927|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604928|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604929|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604930|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604931|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604932|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604933|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604934|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604935|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604936|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605086|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
619013|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
604937|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604938|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604939|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604940|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605272|NCT00997113|B2|Baseline|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
604941|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604942|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604943|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604944|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604945|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604946|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604947|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604948|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604949|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604950|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605132|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604951|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604952|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604953|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604954|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604955|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604956|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604957|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604958|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604959|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604960|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604961|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604962|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604963|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604964|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605133|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604965|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604966|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604967|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604968|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604969|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604970|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604971|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604972|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604973|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604974|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604975|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604976|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604977|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604978|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605134|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604979|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604980|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604981|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604982|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604983|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604984|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604985|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604986|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604987|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604988|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604989|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604990|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604991|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604992|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605135|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
604993|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604994|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604995|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604996|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604997|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604998|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
604999|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605000|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605001|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605002|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605003|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605004|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605005|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605006|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605136|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605007|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605008|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605009|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605010|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605011|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605012|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605013|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605014|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605015|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605016|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605017|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605018|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605019|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605020|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605137|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605021|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605022|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605023|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605024|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605025|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605026|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605027|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605028|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605029|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605030|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605031|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605032|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605033|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605034|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605138|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605035|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605036|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605037|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605038|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605039|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605040|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605041|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605042|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605043|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605044|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605045|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605046|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605047|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605048|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605139|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605049|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605050|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605051|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605052|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605053|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605054|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605055|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605056|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605057|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605058|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605059|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605060|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605089|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605061|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605062|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605063|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605064|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605065|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605066|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605067|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605068|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605069|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605070|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605087|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605071|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605072|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605073|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605074|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605075|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605076|NCT00996892|O1|Outcome|All Participants - Stages 1, 1A, 1B|All participants who received cobimetinib and pictilisib in any dose combination during Stages 1, 1A, and 1B, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605077|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605078|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605079|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605080|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605081|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605082|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605083|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605084|NCT00996892|O11|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605085|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605090|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605091|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605092|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605109|NCT00996892|E4|Reported Event|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
605273|NCT00997113|B1|Baseline|Propofol|"propofol only for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
605093|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605094|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605095|NCT00996892|E18|Reported Event|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605096|NCT00996892|E17|Reported Event|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605097|NCT00996892|E16|Reported Event|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605098|NCT00996892|E15|Reported Event|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605099|NCT00996892|E14|Reported Event|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605100|NCT00996892|E13|Reported Event|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605101|NCT00996892|E12|Reported Event|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605102|NCT00996892|E11|Reported Event|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
605103|NCT00996892|E10|Reported Event|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605104|NCT00996892|E9|Reported Event|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605105|NCT00996892|E8|Reported Event|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605106|NCT00996892|E7|Reported Event|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605107|NCT00996892|E6|Reported Event|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605108|NCT00996892|E5|Reported Event|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605145|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605110|NCT00996892|E3|Reported Event|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605111|NCT00996892|E2|Reported Event|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605112|NCT00996892|E1|Reported Event|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
605113|NCT00996918|B6|Baseline|Total|Total of all reporting groups
605114|NCT00996918|B5|Baseline|Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605115|NCT00996918|B4|Baseline|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605116|NCT00996918|B3|Baseline|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605117|NCT00996918|B2|Baseline|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605118|NCT00996918|B1|Baseline|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605119|NCT00996918|P5|Participant Flow|Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605120|NCT00996918|P4|Participant Flow|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605121|NCT00996918|P3|Participant Flow|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605122|NCT00996918|P2|Participant Flow|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605123|NCT00996918|P1|Participant Flow|Placebo/Bapineuzumab 0.5 Milligram/Kilogram(mg/kg)|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605124|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605351|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
605140|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605141|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605142|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605143|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605144|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605420|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
605149|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605150|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605151|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605152|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605153|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605154|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605155|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605156|NCT00996918|O5|Outcome|Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605157|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605158|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605159|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605160|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605161|NCT00996918|E5|Reported Event|Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605162|NCT00996918|E4|Reported Event|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605163|NCT00996918|E3|Reported Event|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605164|NCT00996918|E2|Reported Event|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
607594|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
605165|NCT00996918|E1|Reported Event|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
605166|NCT00996931|B1|Baseline|Lenalidomide|Six patients will receive 2.5 mg oral daily for 12 weeks
605167|NCT00996931|P1|Participant Flow|Lenalidomide|Six patients will receive oral 2.5 mg daily for 12 weeks
605168|NCT00996931|O1|Outcome|Lenalidomide|oral 25 mg daily for 12 weeks
605169|NCT00996931|O1|Outcome|Lenalidomide|Six subjects received oral 2.5 mg daily for 12 weeks
605170|NCT00996931|E1|Reported Event|Lenalidomide|Six patients will receive 2.5 mg oral daily for 12 weeks
605171|NCT00996944|B3|Baseline|Total|Total of all reporting groups
605172|NCT00996944|B2|Baseline|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605173|NCT00996944|B1|Baseline|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605274|NCT00997113|P2|Participant Flow|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
605174|NCT00996944|P2|Participant Flow|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605175|NCT00996944|P1|Participant Flow|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression–Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605176|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605177|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression–Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605178|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605179|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605180|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605192|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605352|NCT00997334|E1|Reported Event|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
605353|NCT00997373|B3|Baseline|Total|Total of all reporting groups
605181|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605182|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605183|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605275|NCT00997113|P1|Participant Flow|Propofol|"propofol only for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
611630|NCT01019928|O1|Outcome|AZD1386 95 mg|
605184|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605185|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605186|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605187|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605188|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605189|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605190|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605191|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605260|NCT00997035|O1|Outcome|Oral Voriconazole|Oral voriconazole treated participants
605261|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agents
605262|NCT00997035|O1|Outcome|Oral Voriconazole|Oral voriconazole treated participants
605193|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605194|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605195|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605196|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605197|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605198|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605199|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605200|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605201|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605202|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605203|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605263|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agents
605264|NCT00997035|O1|Outcome|Oral Voriconazole|Oral Voriconazole plus topical antifungal agents
605204|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605205|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605206|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605276|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
605277|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
611631|NCT01019928|O2|Outcome|Placebo|
605207|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605208|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605209|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605210|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605211|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605212|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605213|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605214|NCT00996944|E2|Reported Event|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
605265|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agents
605266|NCT00997035|O1|Outcome|Oral Voriconazole|Oral Voriconazole plus topical antifungal agents
605267|NCT00997035|O2|Outcome|Oral Placebo|oral placebo plus topical antifungal agents
605268|NCT00997035|O1|Outcome|Oral Voriconazole|oral voriconazole plus topical antifungal agents
605354|NCT00997373|B2|Baseline|Control|No letrozole before hysterectomy
606017|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
605215|NCT00996944|E1|Reported Event|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
605216|NCT00996996|B1|Baseline|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
611632|NCT01019928|O1|Outcome|AZD1386 95 mg|
605217|NCT00996996|P1|Participant Flow|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605218|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605219|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605220|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605221|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605222|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605223|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605224|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605308|NCT00997204|B2|Baseline|Naive Patients|Patients who had never received icatibant and treated in both the Naive treatment phase and the Self-administered phase
607595|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
605225|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605226|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605421|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
605227|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605228|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605229|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605230|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605231|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605232|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605233|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605234|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605309|NCT00997204|B1|Baseline|Non-Naive Patients|Patients who previously treated with icatibant in clinical studies or with commercial Firazyr® and got the treatment during the self-administered phase
605355|NCT00997373|B1|Baseline|Letrozole Arm|Grade 1 or 2 endometrial cancer treated 3 weeks before hysterectomy of repeat biopsy. Letrozole 2.5 mg PO daily.
619014|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
605235|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605236|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605237|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605238|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605239|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605240|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605241|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605242|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605243|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605244|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605310|NCT00997204|P2|Participant Flow|Non-Naive Subjects/ Self-administration Phase|Subjects who had received treatment for HAE with icatibant in previous clinical trials or had been previously treated with the marketed product Firazyr®, got Treatment of Acute HAE Attack with SC icatibant (30 mg)Self-Administered.
605356|NCT00997373|P2|Participant Flow|Control|No treatment prior to hysterectomy
605245|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605246|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
611633|NCT01019928|O2|Outcome|Placebo|
605247|NCT00996996|E1|Reported Event|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
605248|NCT00997035|B3|Baseline|Total|Total of all reporting groups
605249|NCT00997035|B2|Baseline|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
605250|NCT00997035|B1|Baseline|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
605251|NCT00997035|P2|Participant Flow|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
605252|NCT00997035|P1|Participant Flow|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
605253|NCT00997035|O2|Outcome|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
605254|NCT00997035|O1|Outcome|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
605255|NCT00997035|O2|Outcome|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
605256|NCT00997035|O1|Outcome|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
605257|NCT00997035|O2|Outcome|Oral Placebo|oral placebo plus topical antifungal
605258|NCT00997035|O1|Outcome|Oral Voriconazole|oral voriconazole plus topical antifungal
605259|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agent
605269|NCT00997035|E2|Reported Event|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
605270|NCT00997035|E1|Reported Event|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
605271|NCT00997113|B3|Baseline|Total|Total of all reporting groups
605278|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
605279|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
605280|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
605281|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
605282|NCT00997113|E2|Reported Event|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
605283|NCT00997113|E1|Reported Event|Propofol|"propofol only for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
605284|NCT00997126|B3|Baseline|Total|Total of all reporting groups
605285|NCT00997126|B2|Baseline|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
605286|NCT00997126|B1|Baseline|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
605287|NCT00997126|P2|Participant Flow|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
605288|NCT00997126|P1|Participant Flow|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
605289|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
605290|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
605291|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
605292|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
605293|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
605294|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
605295|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
605296|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
605297|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
605298|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
605299|NCT00997126|E2|Reported Event|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
605300|NCT00997126|E1|Reported Event|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
605301|NCT00997139|B1|Baseline|Treatment Group|Baseline culture positive for Staphylococcus aureus
605302|NCT00997139|P1|Participant Flow|All Subjects|
605303|NCT00997139|O1|Outcome|MRSA|Subjects with Baseline culture positive for methicillin-resistant Staphylococcus aureus
605304|NCT00997139|O1|Outcome|MSSA|Baseline culture positive for methicillin-susceptible staphylococcus aureus
605305|NCT00997139|O1|Outcome|All Subjects|All subjects enrolled
605306|NCT00997139|E1|Reported Event|All Subjects|
605307|NCT00997204|B3|Baseline|Total|Total of all reporting groups
605317|NCT00997204|O1|Outcome|Naive Subjects Administered Icatibant by Health Care Provider|"The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
3 subjects (of the original 25 enrolled in the naive treatment phase)self-administered icatibant while observed bu HCP, as opposed to having the HCP perform the injection. these data were not included in the naive treatment safety analyses."
605318|NCT00997204|E3|Reported Event|Subjects Who Self-administered Icatibant (Non-naive)|Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
605319|NCT00997204|E2|Reported Event|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
605320|NCT00997204|E1|Reported Event|Naive Subjects Administered Icatibant by Health Care Provider|The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
605321|NCT00997243|B1|Baseline|75 mg/m2 5-azacytidine (Vidaza, AZA) and 600 mg Lintuzumab|5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7 cycle 1 and all subsequent cycles. Lintuzumab 600mg as an IV infusion (flat dose for all), given on days 2, 7, 15, and 22 for cycle 1 and 600mg as an IV infusion, given every other week, twice during each cycle, including one dose given during AZA therapy for all other subsequent cycles.
605322|NCT00997243|P1|Participant Flow|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.
Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
605323|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.
Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
605324|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.
Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
605734|NCT01005251|E1|Reported Event|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
605325|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.
Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
605326|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.
Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
605327|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.
Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
605328|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.
Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
605329|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.
Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
605330|NCT00997243|E1|Reported Event|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.
Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
605331|NCT00997321|B3|Baseline|Total|Total of all reporting groups
605332|NCT00997321|B2|Baseline|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
605333|NCT00997321|B1|Baseline|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
605334|NCT00997321|P2|Participant Flow|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
605335|NCT00997321|P1|Participant Flow|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
605336|NCT00997321|O2|Outcome|Ketamine|median depth of sedation by the observers assesment of alertness scale in the ketamine group
605337|NCT00997321|O1|Outcome|Propofol|median depth of sedation by the observers assesment of alertness scale in the propofol group
605338|NCT00997321|O2|Outcome|Ketamine|percentage of subjects reporting pain after the procedure who received ketamine
605339|NCT00997321|O1|Outcome|Propofol|percentage of subjects reporting pain after the procedure who received propofol
605340|NCT00997321|O2|Outcome|Ketamine|time in minutes from the start of the procedure until the return of baseline mental status
605341|NCT00997321|O1|Outcome|Propofol|time in minutes from the start of the procedure until the return of baseline mental status
605342|NCT00997321|O2|Outcome|Ketamine|percentage of participants with respiratory depression
605343|NCT00997321|O1|Outcome|Propofol|percentage of participants with respiratory depression
605344|NCT00997321|E2|Reported Event|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
605345|NCT00997321|E1|Reported Event|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
605346|NCT00997334|B1|Baseline|Erlotinib|Patients receive standard dose of erlotinib 150mg daily with cycle length of 28 days; Patients are treated until disease progression or until unaccepted drug toxicity.
605347|NCT00997334|P1|Participant Flow|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
605348|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
605349|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
605350|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
605357|NCT00997373|P1|Participant Flow|Letrozole|"Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy.
Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm)."
605358|NCT00997373|O2|Outcome|Control|no treatemtn prior to hysterectomy
605359|NCT00997373|O1|Outcome|Letrozole|"letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.
Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks"
605360|NCT00997373|E2|Reported Event|Control|No treatment prior to hysterectomy
605361|NCT00997373|E1|Reported Event|Letrozole|"Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy.
Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm)."
605362|NCT01004354|B1|Baseline|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
605363|NCT01004354|P1|Participant Flow|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
605364|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
605365|NCT01004354|E1|Reported Event|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
605366|NCT01004393|B1|Baseline|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
605414|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
605367|NCT01004393|P1|Participant Flow|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
605368|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
605369|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
605370|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
605371|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
605372|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
605373|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
605374|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
605375|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
605376|NCT01004393|E1|Reported Event|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
605377|NCT01004432|B1|Baseline|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
605378|NCT01004432|P5|Participant Flow|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
605379|NCT01004432|P4|Participant Flow|DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
605380|NCT01004432|P3|Participant Flow|Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
605381|NCT01004432|P2|Participant Flow|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
605382|NCT01004432|P1|Participant Flow|Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
605383|NCT01004432|O4|Outcome|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
605384|NCT01004432|O3|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
605385|NCT01004432|O2|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
605386|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
605387|NCT01004432|O4|Outcome|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
605388|NCT01004432|O3|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
605415|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
605389|NCT01004432|O2|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
605390|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
605391|NCT01004432|O2|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
605392|NCT01004432|O1|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
605393|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
605394|NCT01004432|O1|Outcome|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
605395|NCT01004432|O1|Outcome|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
605396|NCT01004432|E5|Reported Event|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
605397|NCT01004432|E4|Reported Event|DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
605398|NCT01004432|E3|Reported Event|Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
605399|NCT01004432|E2|Reported Event|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
605400|NCT01004432|E1|Reported Event|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
605401|NCT01004510|B1|Baseline|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
605402|NCT01004510|P1|Participant Flow|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy. Zoledronic acid dose per package insert for up to 4 cycles.
605403|NCT01004510|O1|Outcome|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
605404|NCT01004510|E1|Reported Event|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
605405|NCT01004614|B5|Baseline|Total|Total of all reporting groups
605406|NCT01004614|B4|Baseline|2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water|One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
605407|NCT01004614|B3|Baseline|3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water|One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
605408|NCT01004614|B2|Baseline|2nd OD Tablet With Water, Then 3rd OD Tablet With Water|One amlodipine second generation OD 5mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
605409|NCT01004614|B1|Baseline|3rd OD Tablet With Water, Then 2nd OD Tablet With Water|One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during the second intervention period. A washout of 14 days was retained between periods.
605410|NCT01004614|P4|Participant Flow|2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water|One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
605411|NCT01004614|P3|Participant Flow|3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water|One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
605412|NCT01004614|P2|Participant Flow|2nd OD Tablet With Water, Then 3rd OD Tablet With Water|One amlodipine second generation OD 5 mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
605413|NCT01004614|P1|Participant Flow|3rd OD Tablet With Water, Then 2nd OD Tablet With Water|One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during second intervention period. A washout of 14 days was retained between periods.
605735|NCT01005290|B1|Baseline|Randomized Patiens|All patients who were randomized to both treatment sequences
605422|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
605423|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
605424|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
605425|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
605426|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
605427|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
605428|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
605429|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
605430|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
605431|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
605432|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
605433|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
605434|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
605435|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
605436|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
605437|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
605438|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
605439|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
605440|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
605441|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
605442|NCT01004614|E4|Reported Event|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
605443|NCT01004614|E3|Reported Event|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
605447|NCT01004705|P3|Participant Flow|Simvastatin Then Combination Pill|After randomization, in Period 1 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks.
605448|NCT01004705|P2|Participant Flow|Combination Pill Then Simvastatin|After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks
605449|NCT01004705|P1|Participant Flow|Pre-randomization Run-In|Screening period with ramipril 2.5 mg
605450|NCT01004705|O2|Outcome|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
605451|NCT01004705|O1|Outcome|Combination Pill|Once daily oral dose of combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks.
605452|NCT01004705|O2|Outcome|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
605453|NCT01004705|O1|Outcome|Combination Pill|Once daily oral dose of combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks.
605454|NCT01004705|E3|Reported Event|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
605455|NCT01004705|E2|Reported Event|Combination Pill|Combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks
605456|NCT01004705|E1|Reported Event|Pre-randomization Run-In|Screening period with ramipril 2.5 mg
605457|NCT01004770|B6|Baseline|Total|Total of all reporting groups
605458|NCT01004770|B5|Baseline|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
605459|NCT01004770|B4|Baseline|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
605460|NCT01004770|B3|Baseline|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
605461|NCT01004770|B2|Baseline|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
605462|NCT01004770|B1|Baseline|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
605463|NCT01004770|P5|Participant Flow|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
605464|NCT01004770|P4|Participant Flow|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
605465|NCT01004770|P3|Participant Flow|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
605466|NCT01004770|P2|Participant Flow|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
605467|NCT01004770|P1|Participant Flow|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
605468|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
605469|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
605470|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
605471|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
605472|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
605473|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
605474|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
605475|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
605476|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
605477|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
605478|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
605479|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
605480|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
605481|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
605482|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
605484|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
605485|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
605486|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
605487|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
605488|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
605489|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
605490|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
605491|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
605492|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
605493|NCT01004770|E5|Reported Event|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
605494|NCT01004770|E4|Reported Event|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
605495|NCT01004770|E3|Reported Event|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
605496|NCT01004770|E2|Reported Event|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
605497|NCT01004770|E1|Reported Event|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
605498|NCT01004822|B9|Baseline|Total|Total of all reporting groups
605499|NCT01004822|B8|Baseline|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605500|NCT01004822|B7|Baseline|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605501|NCT01004822|B6|Baseline|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605502|NCT01004822|B5|Baseline|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605503|NCT01004822|B4|Baseline|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605504|NCT01004822|B3|Baseline|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605505|NCT01004822|B2|Baseline|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605506|NCT01004822|B1|Baseline|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605507|NCT01004822|P8|Participant Flow|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605508|NCT01004822|P7|Participant Flow|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605509|NCT01004822|P6|Participant Flow|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605510|NCT01004822|P5|Participant Flow|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605511|NCT01004822|P4|Participant Flow|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605512|NCT01004822|P3|Participant Flow|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605513|NCT01004822|P2|Participant Flow|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605514|NCT01004822|P1|Participant Flow|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605515|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605516|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605517|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605518|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605519|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605520|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605521|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605522|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605523|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605524|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605525|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605526|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605527|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605528|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605529|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605530|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605531|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605532|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605533|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605534|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605535|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605536|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605537|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605538|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605539|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in four-week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605540|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605541|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605542|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605543|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605544|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605545|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605546|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605547|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605548|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605549|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605550|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605551|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605552|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605553|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605554|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605555|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605556|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605557|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605558|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605559|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605560|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605561|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605562|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605563|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605564|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605565|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605566|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605567|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605568|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605569|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605570|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605571|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605572|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605573|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605574|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605575|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605576|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605577|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
607596|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
605578|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605579|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605580|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605581|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605582|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605583|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605584|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605585|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605586|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605587|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605588|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605589|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605590|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605643|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605591|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605592|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605593|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605594|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605595|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605596|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605597|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605598|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605599|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605600|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605601|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605602|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605603|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605604|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605605|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605606|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605607|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
619015|NCT01037244|O4|Outcome|Placebo|Placebo tablets
605608|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605609|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605610|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605611|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605612|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605613|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in four-week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605614|NCT01004822|E8|Reported Event|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605615|NCT01004822|E7|Reported Event|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605616|NCT01004822|E6|Reported Event|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605617|NCT01004822|E5|Reported Event|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605618|NCT01004822|E4|Reported Event|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605619|NCT01004822|E3|Reported Event|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605724|NCT01005251|O1|Outcome|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
605725|NCT01005251|O5|Outcome|Placebo|PPI+Placebo
605620|NCT01004822|E2|Reported Event|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605621|NCT01004822|E1|Reported Event|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
605622|NCT01004848|B3|Baseline|Total|Total of all reporting groups
605623|NCT01004848|B2|Baseline|Delayed Intervention|The control group offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605624|NCT01004848|B1|Baseline|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aimed to help participants lose weight, thereby preventing their progression to diabetes."
605625|NCT01004848|P2|Participant Flow|Delayed Intervention|The control group was be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605626|NCT01004848|P1|Participant Flow|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605627|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605628|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605629|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605630|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605631|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605632|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605633|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605897|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605634|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605635|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605636|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605637|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605638|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605639|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605640|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605641|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605642|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605644|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605645|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605646|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605647|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605648|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605649|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605650|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605651|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605652|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605653|NCT01004848|E2|Reported Event|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
605654|NCT01004848|E1|Reported Event|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
605669|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
607597|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
605655|NCT01004874|B1|Baseline|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.
This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
605656|NCT01004874|P1|Participant Flow|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.
This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
605657|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.
This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
605658|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.
This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
605659|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.
This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
605726|NCT01005251|O4|Outcome|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
605727|NCT01005251|O3|Outcome|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
605660|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.
This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
605661|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.
This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
605662|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.
This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
605663|NCT01004874|E1|Reported Event|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.
This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
605664|NCT01004939|B1|Baseline|Fondaparinux|Retrospective systematic documentation of female participants treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605665|NCT01004939|P1|Participant Flow|Fondaparinux|Retrospective systematic documentation of female participants treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605666|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605667|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605668|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605670|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605671|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605672|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605673|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605674|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605675|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605676|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605728|NCT01005251|O2|Outcome|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
605729|NCT01005251|O1|Outcome|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
605730|NCT01005251|E5|Reported Event|Placebo|PPI+Placebo
605677|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605678|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605679|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605680|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605681|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605682|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605683|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605684|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
605685|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
605686|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
605820|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605687|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
605688|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
605689|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
605690|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605691|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605692|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605693|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605694|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605695|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605696|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605697|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605698|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605699|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605700|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605701|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605702|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
605703|NCT01004939|E2|Reported Event|Fondaparinux - Child|Events reported for children (including 4 twins) born to mothers receiving Fondaparinux
605704|NCT01004939|E1|Reported Event|Fondaparinux - Mother|Events reported for mothers receiving Fondaparinux
605705|NCT01004991|B1|Baseline|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP
rituximab: 375 mg/m2 on Day 8 of each of 6 cycles
cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles
vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles
doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles
prednisone: 100 mg PO days 8-12 of each of 6 cycles
azacytidine: ﻿Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
605706|NCT01004991|P1|Participant Flow|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP
rituximab: 375 mg/m2 on Day 8 of each of 6 cycles
cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles
vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles
doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles
prednisone: 100 mg PO days 8-12 of each of 6 cycles
azacytidine: ﻿Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
605707|NCT01004991|O1|Outcome|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP
rituximab: 375 mg/m2 on Day 8 of each of 6 cycles
cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles
vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles
doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles
prednisone: 100 mg PO days 8-12 of each of 6 cycles
azacytidine: ﻿Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
605708|NCT01004991|E1|Reported Event|All Patients|all study patients
605709|NCT01005251|B6|Baseline|Total|Total of all reporting groups
605710|NCT01005251|B5|Baseline|Placebo|PPI+Placebo
605711|NCT01005251|B4|Baseline|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
605712|NCT01005251|B3|Baseline|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
605713|NCT01005251|B2|Baseline|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
605714|NCT01005251|B1|Baseline|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
605715|NCT01005251|P5|Participant Flow|Placebo|PPI+Placebo
605716|NCT01005251|P4|Participant Flow|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
605717|NCT01005251|P3|Participant Flow|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
605718|NCT01005251|P2|Participant Flow|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
605719|NCT01005251|P1|Participant Flow|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
605720|NCT01005251|O5|Outcome|Placebo|PPI+Placebo
605721|NCT01005251|O4|Outcome|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
605722|NCT01005251|O3|Outcome|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
605723|NCT01005251|O2|Outcome|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
605736|NCT01005290|P3|Participant Flow|Ramipril Then Combination Pill|After randomization, in Period 1 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.
605737|NCT01005290|P2|Participant Flow|Combination Pill Then Ramipril|After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks
605738|NCT01005290|P1|Participant Flow|Pre-randomization Run-In|Screening period with ramipril 2.5 mg once daily
605739|NCT01005290|O2|Outcome|Ramipril|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
605740|NCT01005290|O1|Outcome|Combination Pill|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
605741|NCT01005290|O2|Outcome|Ramipril|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
605742|NCT01005290|O1|Outcome|Combination Pill|Difference in the adjusted mean 24-h systolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
605743|NCT01005290|E2|Reported Event|Ramipril|
605744|NCT01005290|E1|Reported Event|Combination Pill|
605745|NCT01005316|B4|Baseline|Total|Total of all reporting groups
605746|NCT01005316|B3|Baseline|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605898|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605747|NCT01005316|B2|Baseline|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605748|NCT01005316|B1|Baseline|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605749|NCT01005316|P4|Participant Flow|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605750|NCT01005316|P3|Participant Flow|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605751|NCT01005316|P2|Participant Flow|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605789|NCT01005316|O1|Outcome|Enrolled|Enrolled participants who died, were transplanted or de-listed.
605752|NCT01005316|P1|Participant Flow|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did not receive a heart transplant as specified by the protocol.
605753|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605754|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605755|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605756|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605899|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605757|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605758|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605759|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605760|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605761|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605762|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605763|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605764|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605765|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605821|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605766|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605767|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605768|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605769|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605770|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605771|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605772|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605773|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605774|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605822|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605775|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605776|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605777|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605778|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605779|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605780|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605781|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605782|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605783|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605823|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605784|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605785|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605786|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605787|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605788|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605790|NCT01005316|O1|Outcome|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did not receive a heart transplant as specified by the protocol.
605791|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605792|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605793|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction),
605794|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605870|NCT01005602|O1|Outcome|Wild Type|Genotypes for the ABCB1 single nucleotide polymorphism C1236T
606212|NCT01006603|P2|Participant Flow|Glimepiride 1 - 6 mg|Glimepiride : 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
605795|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605796|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605797|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605798|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605799|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
606773|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
605800|NCT01005316|E3|Reported Event|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605801|NCT01005316|E2|Reported Event|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R))
605802|NCT01005316|E1|Reported Event|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
605803|NCT01005329|B1|Baseline|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
605804|NCT01005329|P1|Participant Flow|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
605805|NCT01005329|O1|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
605806|NCT01005329|E1|Reported Event|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
605807|NCT01005355|B4|Baseline|Total|Total of all reporting groups
605808|NCT01005355|B3|Baseline|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605809|NCT01005355|B2|Baseline|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605810|NCT01005355|B1|Baseline|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605811|NCT01005355|P3|Participant Flow|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605881|NCT01005680|B1|Baseline|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles"
606468|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
605812|NCT01005355|P2|Participant Flow|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605813|NCT01005355|P1|Participant Flow|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605814|NCT01005355|O3|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605815|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605816|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605817|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605818|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605819|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605871|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
619016|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
605824|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605825|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605826|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605827|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605828|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605829|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605882|NCT01005680|P2|Participant Flow|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
606469|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
605830|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605831|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605832|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605833|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605834|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605835|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605836|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605837|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605838|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605900|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605839|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605840|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605841|NCT01005355|O3|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605842|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605843|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605844|NCT01005355|E3|Reported Event|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605845|NCT01005355|E2|Reported Event|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605846|NCT01005355|E1|Reported Event|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).
After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
605847|NCT01005459|B3|Baseline|Total|Total of all reporting groups
605848|NCT01005459|B2|Baseline|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
605849|NCT01005459|B1|Baseline|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
605850|NCT01005459|P2|Participant Flow|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
605851|NCT01005459|P1|Participant Flow|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
605852|NCT01005459|O2|Outcome|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
605853|NCT01005459|O1|Outcome|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
605854|NCT01005459|E2|Reported Event|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
605855|NCT01005459|E1|Reported Event|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
605856|NCT01005602|B3|Baseline|Total|Total of all reporting groups
605857|NCT01005602|B2|Baseline|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
605858|NCT01005602|B1|Baseline|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
605859|NCT01005602|P2|Participant Flow|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
605860|NCT01005602|P1|Participant Flow|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
605861|NCT01005602|O4|Outcome|GA Genotype|
605862|NCT01005602|O3|Outcome|TT Genotype|
605863|NCT01005602|O2|Outcome|GT Genotype|
605864|NCT01005602|O1|Outcome|Wild Type (GG)|
605865|NCT01005602|O3|Outcome|TT Genotype|
605866|NCT01005602|O2|Outcome|CT Genotype|
605867|NCT01005602|O1|Outcome|Wild Type (CC)|
605868|NCT01005602|O3|Outcome|TT Genotype|
605869|NCT01005602|O2|Outcome|CT Genotype|
619017|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
605872|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
605873|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
605874|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
605875|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
605876|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
605877|NCT01005602|E2|Reported Event|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
605878|NCT01005602|E1|Reported Event|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
605879|NCT01005680|B3|Baseline|Total|Total of all reporting groups
605880|NCT01005680|B2|Baseline|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles"
605883|NCT01005680|P1|Participant Flow|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605884|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605885|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605886|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605887|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605888|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605889|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605890|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605891|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605892|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605893|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605894|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605895|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605896|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
606013|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
605901|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
605902|NCT01005680|E2|Reported Event|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles"
605903|NCT01005680|E1|Reported Event|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles"
605904|NCT01005706|B3|Baseline|Total|Total of all reporting groups
605905|NCT01005706|B2|Baseline|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.
At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
605906|NCT01005706|B1|Baseline|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
605907|NCT01005706|P2|Participant Flow|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.
At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
605908|NCT01005706|P1|Participant Flow|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
605933|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605909|NCT01005706|O2|Outcome|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.
At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
605910|NCT01005706|O1|Outcome|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
605911|NCT01005706|E2|Reported Event|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.
At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
605912|NCT01005706|E1|Reported Event|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
605913|NCT01005719|B1|Baseline|Overall Study|
605914|NCT01005719|P6|Participant Flow|No Treatment-Prevacid®-Zegerid|Participants received No treatment in Period 1, Prevacid® in Period 2 and Zegerid in Period 3
605915|NCT01005719|P5|Participant Flow|No Treatment-Zegerid-Prevacid®|Participants received No treatment in Period 1, Zegerid in Period 2 and Prevacid® in Period 3
605916|NCT01005719|P4|Participant Flow|Prevacid®-No Treatment-Zegerid|Participants received Prevacid® in Period 1, No treatment in Period 2 and Zegerid in Period 3
605917|NCT01005719|P3|Participant Flow|Prevacid®-Zegerid-No Treatment|Participants received Prevacid® in Period 1, Zegerid in Period 2 and No treatment in Period 3
605918|NCT01005719|P2|Participant Flow|Zegerid-No Treatment-Prevacid®|Participants received Zegerid in Period 1, No treatment in Period 2 and Prevacid® in Period 3
605919|NCT01005719|P1|Participant Flow|Zegerid-Prevacid®-No Treatment|Participants received Zegerid in Period 1, Prevacid® in Period 2 and No treatment in Period 3.
605920|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving in Prevacid® Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605921|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605922|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605923|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605924|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605925|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605926|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605927|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605928|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605929|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605930|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605931|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605932|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605934|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605935|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605936|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605937|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605938|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605939|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605940|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605941|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605942|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605943|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605944|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605945|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
606014|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
605946|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605947|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605948|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605949|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605950|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605951|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605952|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605953|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605954|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605955|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605956|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605957|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605958|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605959|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605960|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605961|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605962|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605963|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605964|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605965|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605966|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605967|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605968|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
606015|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
605969|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605970|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605971|NCT01005719|E3|Reported Event|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605972|NCT01005719|E2|Reported Event|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605973|NCT01005719|E1|Reported Event|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.
All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
605974|NCT01005732|B1|Baseline|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
605975|NCT01005732|P1|Participant Flow|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
606033|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606034|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
605976|NCT01005732|O1|Outcome|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
605977|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
605978|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
605979|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
605980|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
605981|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
605982|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
605983|NCT01005732|O4|Outcome|Uninjured Forearm Skin|Hardness of uninjured forearm skin is provided for comparison.
605984|NCT01005732|O3|Outcome|Kneecap|Hardness of uninjured skin over a bony prominence is provided for comparison.
605985|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
605986|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
605987|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
605988|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
605989|NCT01005732|E1|Reported Event|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
605990|NCT01005745|B1|Baseline|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
619018|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
605991|NCT01005745|P1|Participant Flow|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
605992|NCT01005745|O1|Outcome|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
605993|NCT01005745|O1|Outcome|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
606075|NCT01005966|P4|Participant Flow|NaF Toothpaste (675ppmF)|Study toothpaste containing sodium fluoride and silica (675ppmF as NaF)
605994|NCT01005745|E1|Reported Event|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.
Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.
Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.
Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.
Surgery: Surgery to remove a tumor for growth of TIL
Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
Adoptive Cell Transfer: T-cell infusion
High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
605995|NCT01005875|B1|Baseline|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib
Sorafenib: Nexavar in bottles of 120 tables
Stereotactic Body Radiotherapy (SBRT): SBRT"
605996|NCT01005875|P1|Participant Flow|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib
Sorafenib: Nexavar in bottles of 120 tables
Stereotactic Body Radiotherapy (SBRT): SBRT"
605997|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib
Sorafenib: Nexavar in bottles of 120 tables
Stereotactic Body Radiotherapy (SBRT): SBRT"
605998|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib
Sorafenib: Nexavar in bottles of 120 tables
Stereotactic Body Radiotherapy (SBRT): SBRT"
605999|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib
Sorafenib: Nexavar in bottles of 120 tables
Stereotactic Body Radiotherapy (SBRT): SBRT"
606000|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib
Sorafenib: Nexavar in bottles of 120 tables
Stereotactic Body Radiotherapy (SBRT): SBRT"
606001|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib
Sorafenib: Nexavar in bottles of 120 tables
Stereotactic Body Radiotherapy (SBRT): SBRT"
606002|NCT01005875|E1|Reported Event|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib
Sorafenib: Nexavar in bottles of 120 tables
Stereotactic Body Radiotherapy (SBRT): SBRT"
606003|NCT01005888|B5|Baseline|Total|Total of all reporting groups
606004|NCT01005888|B4|Baseline|Randomized, Not Treated|One subject was randomized but withdrew prior to receiving study drug.
606005|NCT01005888|B3|Baseline|Open-label C1INH-nf Only|One subject received open-label C1INH-nf but withdrew prior to randomization.
606006|NCT01005888|B2|Baseline|Placebo First, Then C1INH-nf|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
606007|NCT01005888|B1|Baseline|C1INH-nf First, Then Placebo|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.
606008|NCT01005888|P2|Participant Flow|Placebo First, Then C1INH-nf|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
606009|NCT01005888|P1|Participant Flow|C1INH-nf First, Then Placebo|1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.
606010|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
606011|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
606012|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
619019|NCT01037244|O4|Outcome|Placebo|Placebo tablets
606018|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
606019|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
606020|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
606021|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
606022|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
606023|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
606024|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
606025|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
606026|NCT01005888|E2|Reported Event|Placebo|
606027|NCT01005888|E1|Reported Event|C1INH-nf|
606028|NCT01005901|B3|Baseline|Total|Total of all reporting groups
606029|NCT01005901|B2|Baseline|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606030|NCT01005901|B1|Baseline|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606031|NCT01005901|P2|Participant Flow|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606032|NCT01005901|P1|Participant Flow|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606035|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606036|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606037|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606038|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606039|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606040|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606041|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606042|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606043|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606044|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606045|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606046|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606047|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606048|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606106|NCT01006018|O1|Outcome|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
+ pioglitazone PLACEBO daily by mouth"
606049|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606050|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606051|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606052|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606053|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606054|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606055|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606056|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606057|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606058|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606059|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606826|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
606060|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606061|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606062|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606063|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606064|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606065|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606066|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606067|NCT01005901|E2|Reported Event|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606068|NCT01005901|E1|Reported Event|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
606069|NCT01005914|B1|Baseline|Group 1|"Drug:cyclophosphamide Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily
Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours
Drug:imatinib mesylate 600 mg/day
Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion
Drug: methylprednisolone Day 1-3: 50mg IV BID
Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV
Drug: vincristine sulfate Day 4 & 11: 2 mg IV
cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3
cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4
dexamethasone: Day 1-4; 11-14: 40 mg daily
doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours
imatinib mesylate: 600 mg/day
methotrexate: D"
606107|NCT01006018|E3|Reported Event|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth
+ pioglitazone (TZD) PLACEBO daily by mouth"
606108|NCT01006018|E2|Reported Event|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
+ pioglitazone (TZD) 15 mg daily by mouth"
606109|NCT01006018|E1|Reported Event|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
+ pioglitazone PLACEBO daily by mouth"
606110|NCT01006122|B1|Baseline|Entire Study|Included all participants randomized to receive PF-03654746 first and placebo first.
619020|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
606070|NCT01005914|P1|Participant Flow|Group 1|"Drug:cyclophosphamide-Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours Drug:imatinib mesylate 600 mg/day Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion Drug: methylprednisolone Day 1-3: 50mg IV BID Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV Drug: vincristine sulfate Day 4 & 11: 2 mg IV
cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3
cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4
dexamethasone: Day 1-4; 11-14: 40 mg daily
doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours
imatinib mesylate: 600 mg/day
methotrexate: D"
606071|NCT01005914|O1|Outcome|Group 1|Cy D1- 3: 300 m g/m2 IV- 6 doses, mesna 600 mg/ m2 /day continuous IV D 1-3, ARAC D 2 & 3: 3g/m2 IV q12 X 4, Dex D1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV, imatinib mesylate 600 mg/day, MTX D1: 1g/ m2 200 mg/ m2 load IV plus 800 mg/ m2, methylprednisolone D 1-3: 50mg IV BID, pegaspargase D3/D4: 2,500 IU/ m2 IV, vincristine sulfate D4 & 11: 2 mg IV, Cy: D 1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day, continuous infusion D 1-3. ARAC D 2 & 3: 3g/m2 IV q12 X 4, dex: D 1-4; 11-14: 40 mg daily, doxorubicin hydrochloride: D 4: 50 mg/m2 IV, imatinib mesylate: 600 mg/day, MTX: D 1: 1g/ m2 200 mg/ m2load IV plus 800 mg/ m2 IV, methylprednisolone: D 1-3: 50mg IV BID, pegaspargase: D 3/D4: 2,500 IU/ m2 IV, vincristine sulfate: D 4 & 11: 2 mg IV, pharmacological study: C1A: pre-dose between Days 1 to 4, C1A: D11 or 12., C1A: D18 or 19, C 1A: D25 or 26, C1A: D32 or 33 C1B: pre-dose between D1-3, C1B: D1 or 11 C1B: D17 or 18, C1B: D24 or 25 C1B: D31 or 32
606072|NCT01005914|E1|Reported Event|Group 1|"cyclophosphamide D1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day cont. IV D1-3, cytarabine D2 & 3: 3g/m2 IV, dexD1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV
Drug:imatinib mesylate 600 mg/day
Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion
Drug: methylprednisolone Day 1-3: 50mg IV BID
Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV
Drug: vincristine sulfate Day 4 & 11: 2 mg IV
cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3
cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4
dexamethasone: Day 1-4; 11-14: 40 mg daily
doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours
imatinib mesylate: 600 mg/day
methotrexate: D"
606073|NCT01005966|B1|Baseline|All Randomized Participants|All randomized participants who received at least one dose of the study treatments or who have been evaluated for AEs were included.
606074|NCT01005966|P5|Participant Flow|Placebo Toothpaste (0ppmF)|Placebo fluoride free toothpaste
606470|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
606076|NCT01005966|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Reference toothpaste containing sodium monofluorophosphate and sodium fluoride (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
606077|NCT01005966|P2|Participant Flow|Amine Fluoride(AmF) Toothpaste (1400ppmF)|Reference toothpaste containing amine fluoride (1400ppm fluoride as AmF)
606078|NCT01005966|P1|Participant Flow|Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F]|Study toothpaste containing sodium fluoride/ silica (1426ppm fluoride as NaF)
606079|NCT01005966|O5|Outcome|Placebo Toothpaste (0ppmF)|Placebo: Fluoride free toothpaste
606080|NCT01005966|O4|Outcome|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/ silica (675ppmF)
606081|NCT01005966|O3|Outcome|Na MFP/NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/NaF (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
606082|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
606083|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
606084|NCT01005966|O5|Outcome|Placebo Toothpaste (0ppmF)|Placebo - fluoride free toothpaste
606085|NCT01005966|O4|Outcome|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/silica (675ppmF)
606086|NCT01005966|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/NaF (1450ppmF– 1000ppmF as NaMFP and 450ppmF as NaF)
606087|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF(1400ppmF)
606088|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
606089|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
606090|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
606091|NCT01005966|E6|Reported Event|Overall|
606092|NCT01005966|E5|Reported Event|Placebo Toothpaste (0ppmF)|Placebo: fluoride free toothpaste
606093|NCT01005966|E4|Reported Event|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/ silica (675ppmF)
606094|NCT01005966|E3|Reported Event|NaMFP/ NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/ NaF (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
606095|NCT01005966|E2|Reported Event|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
606096|NCT01005966|E1|Reported Event|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
606097|NCT01006018|B4|Baseline|Total|Total of all reporting groups
606098|NCT01006018|B3|Baseline|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth
+ pioglitazone (TZD) PLACEBO daily by mouth"
606099|NCT01006018|B2|Baseline|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
+ pioglitazone (TZD) 15 mg daily by mouth"
606100|NCT01006018|B1|Baseline|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
+ pioglitazone PLACEBO daily by mouth"
606101|NCT01006018|P3|Participant Flow|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth
+ pioglitazone (TZD) PLACEBO daily by mouth"
606102|NCT01006018|P2|Participant Flow|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
+ pioglitazone (TZD) 15 mg daily by mouth"
606103|NCT01006018|P1|Participant Flow|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
+ pioglitazone PLACEBO daily by mouth"
606104|NCT01006018|O3|Outcome|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth
+ pioglitazone (TZD) PLACEBO daily by mouth"
606105|NCT01006018|O2|Outcome|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
+ pioglitazone (TZD) 15 mg daily by mouth"
606111|NCT01006122|P2|Participant Flow|Placebo First Then, PF-03654746|Placebo matched to PF-03654746 orally once daily as PIC in the first DB intervention period then PF-03654746 at a starting dose of 0.25 mg to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as PIC in the TP at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week SP at fixed dose stabilized in the TP in the second DB intervention. A washout period of at least 7 days was maintained between each treatment period.
606112|NCT01006122|P1|Participant Flow|PF-03654746 First, Then Placebo|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in the first double-blind (DB) intervention period then placebo matched to PF-03654746 orally once daily as PIC in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
606113|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606114|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606115|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606116|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606117|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606118|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606119|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606471|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
606120|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606121|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606122|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606123|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606124|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606125|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606126|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606127|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606128|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606129|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606130|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606131|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606132|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606133|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606209|NCT01006603|B3|Baseline|Total|Total of all reporting groups
606210|NCT01006603|B2|Baseline|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
606134|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606135|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606136|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606137|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606138|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606139|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606140|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606141|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606142|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606143|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606235|NCT01006616|P4|Participant Flow|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606144|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606145|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606146|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606147|NCT01006122|E2|Reported Event|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
606148|NCT01006122|E1|Reported Event|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
606149|NCT01006135|B1|Baseline|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
606150|NCT01006135|P1|Participant Flow|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
606151|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
606152|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
606153|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
606154|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
606155|NCT01006135|E1|Reported Event|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
606156|NCT01006291|B4|Baseline|Total|Total of all reporting groups
606157|NCT01006291|B3|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
606158|NCT01006291|B2|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
606159|NCT01006291|B1|Baseline|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
606160|NCT01006291|P3|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
606161|NCT01006291|P2|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
606162|NCT01006291|P1|Participant Flow|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
606163|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
606164|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
606165|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
606166|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
606167|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
606168|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
606169|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
606170|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
606171|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
606172|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
606173|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
606174|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
606175|NCT01006291|E3|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
606176|NCT01006291|E2|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
606827|NCT01000961|O2|Outcome|RP103|Per Protocol Population
606177|NCT01006291|E1|Reported Event|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
606178|NCT01006356|B1|Baseline|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606179|NCT01006356|P1|Participant Flow|Hydromorphone Hydrochloride Oral Osmotic System|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606180|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606181|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606182|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606183|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606184|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606185|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606186|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606187|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606188|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606189|NCT01006356|E1|Reported Event|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
606190|NCT01006590|B3|Baseline|Total|Total of all reporting groups
606191|NCT01006590|B2|Baseline|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
606192|NCT01006590|B1|Baseline|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
606193|NCT01006590|P2|Participant Flow|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
606194|NCT01006590|P1|Participant Flow|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
606195|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
606196|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
606197|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
606198|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
606199|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
606200|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
606201|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
606202|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
606203|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
606204|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
606205|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
606206|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
606207|NCT01006590|E2|Reported Event|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
606208|NCT01006590|E1|Reported Event|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
606214|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
606215|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
606216|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
606217|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
606218|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
606219|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
606220|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
606221|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
606222|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
606223|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
606224|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
606225|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
606226|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
606227|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
606228|NCT01006603|E2|Reported Event|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
606229|NCT01006603|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
606230|NCT01006616|B5|Baseline|Total|Total of all reporting groups
606231|NCT01006616|B4|Baseline|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606232|NCT01006616|B3|Baseline|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606233|NCT01006616|B2|Baseline|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606234|NCT01006616|B1|Baseline|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606236|NCT01006616|P3|Participant Flow|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606237|NCT01006616|P2|Participant Flow|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606238|NCT01006616|P1|Participant Flow|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally once daily (QD) for up to 2 years
606239|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606240|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606241|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606242|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606243|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606244|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606245|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606246|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606247|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606248|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606249|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606250|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606251|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606252|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606253|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606254|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606255|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606256|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606257|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606258|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
607598|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
606259|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606260|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606261|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606262|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606263|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606264|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606265|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606266|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606267|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606268|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606269|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606270|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606271|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606272|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606273|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606464|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
606274|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606275|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606276|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606277|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606278|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606279|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606280|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606281|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606282|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606283|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606284|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606285|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606286|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606287|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606288|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606289|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606290|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606291|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606292|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606293|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606294|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606295|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606296|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606297|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
607599|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
606298|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606299|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606300|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606301|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606302|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606303|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606304|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606305|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606306|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606307|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606308|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606309|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606310|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606311|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606312|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606313|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606314|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606315|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606316|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606317|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606318|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606319|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606320|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606321|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606322|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606323|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606324|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606325|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606326|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606327|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606328|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606329|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606330|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606331|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606332|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606333|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606334|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606335|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606336|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
607600|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
606337|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606338|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606339|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606340|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606341|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606342|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606343|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606344|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606345|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606346|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606347|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606348|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606349|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606350|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606351|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606352|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606353|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606354|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606355|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606356|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606357|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606358|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606359|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606360|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606361|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606362|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606363|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606364|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606365|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606366|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606367|NCT01006616|E4|Reported Event|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
606368|NCT01006616|E3|Reported Event|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
606369|NCT01006616|E2|Reported Event|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606370|NCT01006616|E1|Reported Event|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
606371|NCT01006629|B1|Baseline|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
606372|NCT01006629|P1|Participant Flow|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
606373|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
606374|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
606375|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
606376|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
606377|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
619021|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
606378|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
606379|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
606380|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
606381|NCT01006629|E1|Reported Event|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
606382|NCT01006655|B3|Baseline|Total|Total of all reporting groups
606383|NCT01006655|B2|Baseline|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
606384|NCT01006655|B1|Baseline|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
606385|NCT01006655|P2|Participant Flow|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
606386|NCT01006655|P1|Participant Flow|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
606387|NCT01006655|O2|Outcome|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
606388|NCT01006655|O1|Outcome|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
606389|NCT01006655|E2|Reported Event|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
606465|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
606390|NCT01006655|E1|Reported Event|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
606391|NCT01006889|B1|Baseline|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
606392|NCT01006889|P1|Participant Flow|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
606393|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
606394|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
606395|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
606396|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
606397|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
606398|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
606399|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
606400|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
606401|NCT01006889|E1|Reported Event|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
606402|NCT01006980|B3|Baseline|Total|Total of all reporting groups
606444|NCT01007123|B3|Baseline|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
606403|NCT01006980|B2|Baseline|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
606404|NCT01006980|B1|Baseline|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
606405|NCT01006980|P2|Participant Flow|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
606406|NCT01006980|P1|Participant Flow|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
606407|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
606408|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
606409|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
606410|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
606411|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
606412|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
606466|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
606467|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
606413|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
606414|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
606415|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
606416|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
606417|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
606418|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
606419|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
606420|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
606421|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
606422|NCT01006980|E3|Reported Event|Vemurafenib After Crossover|Adverse events reported for this group include those occurring following switch to vemurafenib in those participants who switched from dacarbazine to vemurafenib during the study.
606423|NCT01006980|E2|Reported Event|Dacarbazine|"Adverse events reported for this group include those occurring in participants receiving dacarbazine starting at their baseline visit until study discontinuation or treatment switch.
Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length)."
606424|NCT01006980|E1|Reported Event|Vemurafenib|"Adverse events reported for this group include those occurring in participants receiving vemurafenib starting at their baseline visit.
Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg)."
606425|NCT01007110|B3|Baseline|Total|Total of all reporting groups
606426|NCT01007110|B2|Baseline|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
606427|NCT01007110|B1|Baseline|Placebo|soy/corn oil placebo
606428|NCT01007110|P2|Participant Flow|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
606429|NCT01007110|P1|Participant Flow|Placebo|soy/corn oil placebo
606430|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
606431|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
606432|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
606433|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
606434|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
606435|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
606436|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
606437|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
606438|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid (DHA)
606439|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
606440|NCT01007110|E2|Reported Event|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
606441|NCT01007110|E1|Reported Event|Placebo|soy/corn oil placebo
606442|NCT01007123|B5|Baseline|Total|Total of all reporting groups
606443|NCT01007123|B4|Baseline|Placebo|Administered once daily for the duration of the study
606445|NCT01007123|B2|Baseline|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
606446|NCT01007123|B1|Baseline|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
606447|NCT01007123|P4|Participant Flow|Placebo|Administered once daily for the duration of the study
606448|NCT01007123|P3|Participant Flow|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
606449|NCT01007123|P2|Participant Flow|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
606450|NCT01007123|P1|Participant Flow|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
606451|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
606452|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
606453|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
606454|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
606455|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
606456|NCT01007123|O2|Outcome|Eobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
606457|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
606458|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
606459|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
606460|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
606461|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
606462|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
606463|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
606472|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
606473|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
606474|NCT01007123|E4|Reported Event|Placebo|Administered once daily for the duration of the study
606475|NCT01007123|E3|Reported Event|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
606476|NCT01007123|E2|Reported Event|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
606477|NCT01007123|E1|Reported Event|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
606478|NCT01007149|B3|Baseline|Total|Total of all reporting groups
606479|NCT01007149|B2|Baseline|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606480|NCT01007149|B1|Baseline|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606481|NCT01007149|P2|Participant Flow|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606482|NCT01007149|P1|Participant Flow|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606483|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606484|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606485|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606486|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606487|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606488|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606489|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606490|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606491|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606492|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606493|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606494|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606495|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606496|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606497|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606498|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606499|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606500|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606501|NCT01007149|E2|Reported Event|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
606502|NCT01007149|E1|Reported Event|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
606503|NCT01000285|B3|Baseline|Total|Total of all reporting groups
606504|NCT01000285|B2|Baseline|Lymphoma ATLL|"Bortezomib 1.0 mg/m2 IV Days 1-4
Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4
Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4
Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4
Prednisone 60 mg/m2/d PO on Days 1-5
Cyclophosphamide 375 mg/m2 IV on Day 5
Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.
Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
606505|NCT01000285|B1|Baseline|Acute ATLL|"Bortezomib 1.0 mg/m2 IV Days 1-4
Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4
Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4
Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4
Prednisone 60 mg/m2/d PO on Days 1-5
Cyclophosphamide 375 mg/m2 IV on Day 5
Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.
Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
606506|NCT01000285|P1|Participant Flow|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4
Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4
Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4
Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4
Prednisone 60 mg/m2/d PO on Days 1-5
Cyclophosphamide 375 mg/m2 IV on Day 5
Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.
Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
606507|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4
Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4
Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4
Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4
Prednisone 60 mg/m2/d PO on Days 1-5
Cyclophosphamide 375 mg/m2 IV on Day 5
Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.
Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
606538|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606508|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4
Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4
Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4
Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4
Prednisone 60 mg/m2/d PO on Days 1-5
Cyclophosphamide 375 mg/m2 IV on Day 5
Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.
Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
606509|NCT01000285|O2|Outcome|Non-responders|Patients who had stable or progressive disease after treatment.
606510|NCT01000285|O1|Outcome|Responders|Patients who had a complete or partial response to treatment
606511|NCT01000285|O8|Outcome|Patient D (Non-responder) Post-Therapy|
606512|NCT01000285|O7|Outcome|Patient D (Non-responder) Pre-Therapy|
606513|NCT01000285|O6|Outcome|Patient C (Non-responder) Post-Therapy|
606514|NCT01000285|O5|Outcome|Patient C (Non-responder) Pre-Therapy|
606515|NCT01000285|O4|Outcome|Patient B (Responder) Post-Therapy|
606516|NCT01000285|O3|Outcome|Patient B (Responder) Pre-Therapy|
606517|NCT01000285|O2|Outcome|Patient A (Responder) Post-Therapy|
606518|NCT01000285|O1|Outcome|Patient A (Responder) Pre-Therapy|
606519|NCT01000285|O2|Outcome|Non-responders|Patients who had stable or progressive disease after treatment.
606520|NCT01000285|O1|Outcome|Responders|Patients who had a complete or partial response to treatment
606521|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4
Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4
Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4
Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4
Prednisone 60 mg/m2/d PO on Days 1-5
Cyclophosphamide 375 mg/m2 IV on Day 5
Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.
Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
606522|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4
Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4
Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4
Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4
Prednisone 60 mg/m2/d PO on Days 1-5
Cyclophosphamide 375 mg/m2 IV on Day 5
Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.
Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
606523|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4
Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4
Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4
Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4
Prednisone 60 mg/m2/d PO on Days 1-5
Cyclophosphamide 375 mg/m2 IV on Day 5
Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.
Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
606524|NCT01000285|E1|Reported Event|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4
Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4
Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4
Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4
Prednisone 60 mg/m2/d PO on Days 1-5
Cyclophosphamide 375 mg/m2 IV on Day 5
Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.
Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
606525|NCT01000311|B3|Baseline|Total|Total of all reporting groups
606526|NCT01000311|B2|Baseline|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606554|NCT01000311|E2|Reported Event|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606527|NCT01000311|B1|Baseline|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606528|NCT01000311|P2|Participant Flow|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606529|NCT01000311|P1|Participant Flow|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606530|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606531|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606532|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606533|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606534|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606535|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606536|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606537|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606684|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606539|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606540|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606541|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606542|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606543|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606544|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606545|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606546|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606547|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606548|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606549|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606550|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606551|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606552|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
606553|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606555|NCT01000311|E1|Reported Event|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
606556|NCT01000324|B1|Baseline|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
606557|NCT01000324|P1|Participant Flow|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
606558|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule.
606559|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule.
606560|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
606561|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
606562|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
606563|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
606564|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
606565|NCT01000324|E1|Reported Event|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
606566|NCT01000337|B3|Baseline|Total|Total of all reporting groups
606567|NCT01000337|B2|Baseline|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.
The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
606767|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
606568|NCT01000337|B1|Baseline|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
606569|NCT01000337|P2|Participant Flow|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.
The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
606570|NCT01000337|P1|Participant Flow|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
606571|NCT01000337|O2|Outcome|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.
The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
606572|NCT01000337|O1|Outcome|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
606573|NCT01000337|E2|Reported Event|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.
The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
606574|NCT01000337|E1|Reported Event|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
606575|NCT01000376|B3|Baseline|Total|Total of all reporting groups
606619|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606576|NCT01000376|B2|Baseline|Eribulin Plus Ketoconazole First, Then Eribulin Alone|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
606577|NCT01000376|B1|Baseline|Eribulin Alone First, Then Eribulin Plus Ketoconazole|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
606578|NCT01000376|P2|Participant Flow|Eribulin Plus Ketoconazole First, Then Eribulin Alone|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
606579|NCT01000376|P1|Participant Flow|Eribulin Alone First, Then Eribulin Plus Ketoconazole|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
606580|NCT01000376|O2|Outcome|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
606581|NCT01000376|O1|Outcome|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
606582|NCT01000376|O2|Outcome|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
606583|NCT01000376|O1|Outcome|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
606584|NCT01000376|E2|Reported Event|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
606768|NCT01000727|O2|Outcome|Placebo|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606585|NCT01000376|E1|Reported Event|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
606586|NCT01000480|B1|Baseline|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.
Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).
Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.
Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
606587|NCT01000480|P1|Participant Flow|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.
Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).
Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.
Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
606588|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.
Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).
Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.
Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
606589|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.
Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).
Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.
Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
606590|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.
Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).
Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.
Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
606591|NCT01000480|E1|Reported Event|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.
Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).
Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.
Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
606592|NCT01000506|B5|Baseline|Total|Total of all reporting groups
606593|NCT01000506|B4|Baseline|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606594|NCT01000506|B3|Baseline|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606595|NCT01000506|B2|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606596|NCT01000506|B1|Baseline|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606828|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
606597|NCT01000506|P4|Participant Flow|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606598|NCT01000506|P3|Participant Flow|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606599|NCT01000506|P2|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 milligrams (mg) IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606600|NCT01000506|P1|Participant Flow|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606601|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606602|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606603|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606604|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606605|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606606|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606607|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606608|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606609|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606610|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606611|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606612|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606613|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606614|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606615|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606616|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606617|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606618|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606620|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606621|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606622|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606623|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606624|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606625|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606626|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606627|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606628|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606629|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606630|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606631|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606632|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606633|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606829|NCT01000961|O2|Outcome|Cystagon®|Per Protocol Population
606634|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606635|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606636|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606637|NCT01000506|E4|Reported Event|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606638|NCT01000506|E3|Reported Event|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606639|NCT01000506|E2|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606640|NCT01000506|E1|Reported Event|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
606641|NCT01000610|B1|Baseline|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
606642|NCT01000610|P1|Participant Flow|Rituximab|Participants received rituximab 1000 milligrams (mg) intravenous (iv) infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (less than or equal to [≤] 10 milligrams per day (mg/day) prednisone or equivalent) or intra-articular corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs) and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone100 mg iv prior to each rituximab infusion.
606643|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
606644|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
606645|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
606646|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
606949|NCT01001104|B1|Baseline|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606647|NCT01000610|E1|Reported Event|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
606648|NCT01000649|B5|Baseline|Total|Total of all reporting groups
606649|NCT01000649|B4|Baseline|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606650|NCT01000649|B3|Baseline|FE 202158 3.75|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606651|NCT01000649|B2|Baseline|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606652|NCT01000649|B1|Baseline|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606653|NCT01000649|P4|Participant Flow|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606654|NCT01000649|P3|Participant Flow|FE 202158 3.75|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.The two patients randomized to FE 202158 3.75 ng group were excluded from the efficacy evaluation since meaningful analyses were not possible.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606655|NCT01000649|P2|Participant Flow|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606769|NCT01000727|O1|Outcome|Darapladib 160 mg|Participants were randomized to receive matching placebo once daily.
606830|NCT01000961|O1|Outcome|RP103|Per Protocol Population
606656|NCT01000649|P1|Participant Flow|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606657|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606658|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606659|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606660|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606661|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606662|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606663|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606664|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606665|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606666|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606667|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606668|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606669|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606670|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606671|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606672|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606673|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606748|NCT01000727|P2|Participant Flow|Darapladib 160 mg|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
606674|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606675|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606676|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606677|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606678|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606679|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606680|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606681|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606682|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606683|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606685|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606686|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606687|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606688|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606689|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606690|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606691|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606692|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606693|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606694|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606695|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606696|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606697|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606698|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606699|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606700|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606701|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606702|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606703|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606704|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606705|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606706|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606707|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606708|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606709|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606710|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606711|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606712|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606713|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606714|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606715|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606716|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606717|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606718|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606719|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606720|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606721|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606722|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606723|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606724|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606725|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606726|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606727|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606749|NCT01000727|P1|Participant Flow|Placebo|Participants were randomized to receive matching placebo once daily.
619022|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
606728|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606729|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
606730|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606731|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606732|NCT01000649|E4|Reported Event|PLCBO|Patients in the arm received a continuous intravenous infusion of isotonic saline up to seven consecutive days.
606733|NCT01000649|E3|Reported Event|FE 202158 3.75|"Patients in the arm received a continuous intravenous infusion of FE 202158 3.75 ng/kg/min up to seven consecutive days.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606734|NCT01000649|E2|Reported Event|FE 202158 2.5|"Patients in the arm received a continuous intravenous infusion of FE 202158 2.5 ng/kg/min up to seven consecutive days.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606735|NCT01000649|E1|Reported Event|FE 202158 1.25|"Patients in the arm received a continuous intravenous infusion of FE 202158 1.25 ng/kg/min up to seven consecutive days.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
606736|NCT01000662|B3|Baseline|Total|Total of all reporting groups
606770|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606771|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
606772|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
611634|NCT01019928|O1|Outcome|AZD1386 95 mg|
606737|NCT01000662|B2|Baseline|ARM 2 Weekly Boost|"Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
606738|NCT01000662|B1|Baseline|ARM 1 Daily Boost|"Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
606739|NCT01000662|P2|Participant Flow|ARM 2 Weekly Boost|"Radiation Therapy
15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
606740|NCT01000662|P1|Participant Flow|ARM 1 Daily Boost|"Radiation Therapy
15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed."
606741|NCT01000662|O2|Outcome|ARM 2 Weekly Boost|"Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
606742|NCT01000662|O1|Outcome|ARM 1 Daily Boost|"Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
606743|NCT01000662|E2|Reported Event|ARM 2 Weekly Boost|"Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
606744|NCT01000662|E1|Reported Event|ARM 1 Daily Boost|"Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
606745|NCT01000727|B3|Baseline|Total|Total of all reporting groups
606746|NCT01000727|B2|Baseline|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606747|NCT01000727|B1|Baseline|Placebo|Participants were randomized to receive matching placebo once daily.
606750|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606751|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
606752|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606753|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
606754|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606755|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
606756|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606757|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
606758|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606759|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
606760|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606761|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
606762|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606763|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
606764|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606765|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
606766|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606774|NCT01000727|E2|Reported Event|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
606775|NCT01000727|E1|Reported Event|Placebo|Participants were randomized to receive matching placebo once daily.
606776|NCT01000805|B3|Baseline|Total|Total of all reporting groups
606777|NCT01000805|B2|Baseline|Placebo|Participants received placebo QD, po for 8 weeks.
606778|NCT01000805|B1|Baseline|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606779|NCT01000805|P2|Participant Flow|Placebo|Participants received placebo QD, po for 8 weeks.
606780|NCT01000805|P1|Participant Flow|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606781|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606782|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606783|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606784|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606785|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606786|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks.
606787|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606788|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606789|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606790|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606791|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606792|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606793|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606794|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606795|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606796|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606797|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606798|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606799|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606800|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606801|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606802|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606803|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606804|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606805|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606806|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks.
606807|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
606808|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606809|NCT01000805|E2|Reported Event|Placebo|Participants received placebo QD, po for 8 weeks.
606810|NCT01000805|E1|Reported Event|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
606811|NCT01000818|B1|Baseline|Raltegravir/Famotidine/Omeprazole|"Period 1 - 400 mg Raltegravir x 1 day
Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day
Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days"
606812|NCT01000818|P1|Participant Flow|Raltegravir/Famotidine/Omeprazole|"Period 1 - 400 mg Raltegravir x 1 day
Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day
Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days"
606813|NCT01000818|O3|Outcome|20 mg Omeprazole + 400 mg Raltegravir|Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
606814|NCT01000818|O2|Outcome|20 mg Famotidine + 400 mg Raltegravir|Period 2 - 20 mg Famotidine + 400 mg Raltegravir
606815|NCT01000818|O1|Outcome|400 mg Raltegravir|Period 1 - 400 mg Raltegravir
606816|NCT01000818|E4|Reported Event|20 mg Omeprazole + 400 mg Raltegravir|Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
606817|NCT01000818|E3|Reported Event|20 mg Famotidine + 400 mg Raltegravir|Period 2 - 20 mg Famotidine + 400 mg Raltegravir
606818|NCT01000818|E2|Reported Event|400 mg Raltegravir|Period 1 - 400 mg Raltegravir
606819|NCT01000818|E1|Reported Event|Prestudy|
606820|NCT01000961|B1|Baseline|RP103 and Cystagon® Crossover|Per Protocol Population
606821|NCT01000961|P2|Participant Flow|Cystagon First, Then RP103, Then Cystagon|RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in first intervention (after Run-in period) and Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in second intervention period.
606822|NCT01000961|P1|Participant Flow|Cystagon First, Then Cystagon, Then RP103|Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in first intervention (after Run-in period) and RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in second intervention period.
606823|NCT01000961|O2|Outcome|RP103|Per Protocol Population
606824|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
606825|NCT01000961|O2|Outcome|RP103|Per Protocol Population
606831|NCT01000961|E2|Reported Event|Cystagon®|Safety population during treatment periods
606832|NCT01000961|E1|Reported Event|RP103|Safety Population during treatment periods
606833|NCT01000974|B4|Baseline|Total|Total of all reporting groups
606834|NCT01000974|B3|Baseline|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606835|NCT01000974|B2|Baseline|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606836|NCT01000974|B1|Baseline|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606837|NCT01000974|P3|Participant Flow|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606915|NCT01001052|B1|Baseline|Colcrys™ - Young Subjects and Colcrys™ - Elderly Subjects|"Colcrys™ (colchicine) - young subjects (18-30 years): All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
Colcrys™ (colchicine) - Elderly subjects (≥60 years): All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours."
619023|NCT01037244|O4|Outcome|Placebo|Placebo tablets
606838|NCT01000974|P2|Participant Flow|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606839|NCT01000974|P1|Participant Flow|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606840|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606841|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606842|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606924|NCT01001052|E2|Reported Event|Colcrys™ - Elderly Subjects (>60 Years Old)|All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
606925|NCT01001052|E1|Reported Event|Colcrys™ - Young Subjects (18-30 Years)|All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
606926|NCT01001078|B3|Baseline|Total|Total of all reporting groups
606843|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606844|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606845|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606846|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606847|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606848|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606950|NCT01001104|P4|Participant Flow|Placebo|Administered by SC injection, QW for 12 weeks.
606849|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606850|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606851|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606852|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606968|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606969|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
606970|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606971|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606853|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606854|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606855|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606856|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606857|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606858|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606859|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606860|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606861|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606862|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606863|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606972|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606864|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606865|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606866|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606867|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606868|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606869|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally
606881|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606951|NCT01001104|P3|Participant Flow|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606870|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606871|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606872|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606973|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
606974|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606975|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606976|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606977|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
606873|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606874|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606875|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606876|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606877|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606878|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606879|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606880|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606882|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606883|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606884|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606885|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606886|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606887|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606888|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606889|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606890|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally
606891|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606892|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606893|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606894|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606895|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606896|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606897|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606898|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606899|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606900|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606901|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606902|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606914|NCT01000974|E1|Reported Event|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
619024|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
606903|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606904|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606905|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606906|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606907|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606908|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606909|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606910|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606911|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606912|NCT01000974|E3|Reported Event|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
606913|NCT01000974|E2|Reported Event|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
606916|NCT01001052|P2|Participant Flow|Colcrys™ (Colchicine) - Elderly Subjects (>60 Years)|All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
606917|NCT01001052|P1|Participant Flow|Colcrys™ (Colchicine) - Young Subjects (18-30 Years)|All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
606918|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
606919|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
606920|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
606921|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
606922|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
606923|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
606927|NCT01001078|B2|Baseline|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
606928|NCT01001078|B1|Baseline|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
606929|NCT01001078|P2|Participant Flow|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
606930|NCT01001078|P1|Participant Flow|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
606931|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
606932|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
606933|NCT01001078|O2|Outcome|LMA Supreme|Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
606934|NCT01001078|O1|Outcome|I-Gel|Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
606935|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
606936|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
606978|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606979|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606980|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606981|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
606982|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606983|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606937|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
606938|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
606939|NCT01001078|O2|Outcome|LMA Supreme|Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
606940|NCT01001078|O1|Outcome|I-Gel|Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
606941|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
606942|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
606943|NCT01001078|E2|Reported Event|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
606944|NCT01001078|E1|Reported Event|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
606945|NCT01001104|B5|Baseline|Total|Total of all reporting groups
606946|NCT01001104|B4|Baseline|Placebo|Administered by SC injection, QW for 12 weeks.
606947|NCT01001104|B3|Baseline|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606948|NCT01001104|B2|Baseline|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606953|NCT01001104|P1|Participant Flow|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606954|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
606955|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606956|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606957|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606958|NCT01001104|O3|Outcome|LY 0.75 mg|Administered by SC injection, QW for 12 weeks.
606959|NCT01001104|O2|Outcome|LY 0.50 mg|Administered by SC injection, QW for 12 weeks.
606960|NCT01001104|O1|Outcome|LY 0.25 mg|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606961|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
606962|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606963|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606964|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606965|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
606966|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606967|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
611635|NCT01019928|O2|Outcome|Placebo|
606984|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606985|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
606986|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606987|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606988|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606989|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
606990|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606991|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606992|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606993|NCT01001104|E4|Reported Event|0.75 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606994|NCT01001104|E3|Reported Event|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606995|NCT01001104|E2|Reported Event|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
606996|NCT01001104|E1|Reported Event|Placebo|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
606997|NCT01001169|B3|Baseline|Total|Total of all reporting groups
606998|NCT01001169|B2|Baseline|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
606999|NCT01001169|B1|Baseline|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607000|NCT01001169|P2|Participant Flow|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607001|NCT01001169|P1|Participant Flow|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607002|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607003|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607004|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607005|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607006|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607007|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607008|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607009|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607010|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607011|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607012|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607013|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607014|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607015|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607016|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607017|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607018|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607019|NCT01001169|O1|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607020|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607021|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607022|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607458|NCT01001429|O3|Outcome|UMSS Scores in Propofol Infusion Group|Propofol medication administered as described in BIS group/Propofol group
607023|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607024|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607025|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607026|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607027|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607028|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607029|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607030|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607048|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607570|NCT01001767|P1|Participant Flow|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
607031|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607032|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607033|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607034|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607035|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607036|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607037|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607038|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607039|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607543|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
607040|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607041|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607042|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607043|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607044|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607045|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607046|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607047|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607481|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
607049|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607050|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607051|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607052|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607053|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607054|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607055|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607056|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607057|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607058|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
619025|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
607059|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607060|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607061|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607062|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607063|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607064|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607065|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607066|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607102|NCT01001169|E2|Reported Event|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607067|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607068|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607069|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607070|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607071|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607072|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607073|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607074|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607075|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607076|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607118|NCT01001195|E3|Reported Event|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607601|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
607077|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607078|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607079|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607080|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607081|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607082|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607083|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607084|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607374|NCT01001325|B3|Baseline|Total|Total of all reporting groups
607085|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607086|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607087|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607088|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607089|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
607090|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607091|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607092|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607093|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607094|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607119|NCT01001195|E2|Reported Event|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607602|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
607095|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607096|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607097|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607098|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607099|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607100|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
607101|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607103|NCT01001169|E1|Reported Event|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
607104|NCT01001195|B5|Baseline|Total|Total of all reporting groups
607105|NCT01001195|B4|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607106|NCT01001195|B3|Baseline|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607107|NCT01001195|B2|Baseline|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607108|NCT01001195|B1|Baseline|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607109|NCT01001195|P4|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607110|NCT01001195|P3|Participant Flow|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607111|NCT01001195|P2|Participant Flow|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607112|NCT01001195|P1|Participant Flow|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607113|NCT01001195|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607114|NCT01001195|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607115|NCT01001195|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607116|NCT01001195|O1|Outcome|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607117|NCT01001195|E4|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607120|NCT01001195|E1|Reported Event|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
607121|NCT01001208|B3|Baseline|Total|Total of all reporting groups
607122|NCT01001208|B2|Baseline|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607123|NCT01001208|B1|Baseline|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607124|NCT01001208|P2|Participant Flow|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607125|NCT01001208|P1|Participant Flow|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607126|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607127|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607128|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607375|NCT01001325|B2|Baseline|Placebo|0.5 mL normal saline
607376|NCT01001325|B1|Baseline|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
607129|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607130|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607131|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607132|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607133|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607134|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607135|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607136|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607137|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607138|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607160|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607139|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607140|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607141|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607142|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607143|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607144|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607145|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607377|NCT01001325|P2|Participant Flow|Placebo|0.5 mL normal saline
607482|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
607146|NCT01001208|E2|Reported Event|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
607147|NCT01001208|E1|Reported Event|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
607148|NCT01001221|B5|Baseline|Total|Total of all reporting groups
607149|NCT01001221|B4|Baseline|Part 1: Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607150|NCT01001221|B3|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607151|NCT01001221|B2|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607152|NCT01001221|B1|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607153|NCT01001221|P5|Participant Flow|Part 2: Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the Maximum Tolerated Dose (MTD) as determined in study part 1
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607154|NCT01001221|P4|Participant Flow|Part 1: Gemcitabine + Cabazitaxel Dose Level 0|"gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607155|NCT01001221|P3|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607156|NCT01001221|P2|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607157|NCT01001221|P1|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607158|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607159|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
619026|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
607161|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607162|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607163|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607164|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607165|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607166|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607167|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607168|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607169|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607170|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607171|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607172|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607173|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607174|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607175|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607176|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607177|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607178|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607179|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607180|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607181|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607182|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607183|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607345|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
607346|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
607184|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607185|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607186|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607187|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607188|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607189|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607190|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607191|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607192|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607193|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607194|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607195|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607196|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607197|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607198|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607199|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607200|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607201|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607202|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607203|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607204|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607205|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607206|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607347|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
607348|NCT01001234|E2|Reported Event|Placebo|Participants who took only placebo during the study
607207|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607208|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607209|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607210|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607211|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607212|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607213|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607214|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607215|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607216|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607217|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607218|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607219|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607220|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607221|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607222|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607223|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607224|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607225|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607226|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607227|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607228|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607229|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607349|NCT01001234|E1|Reported Event|Rizatriptan|Participants who took any rizatriptan during the study (Stage 1 or 2)
607603|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
607230|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607231|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607232|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607233|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607234|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607235|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607236|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607237|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607238|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607239|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607240|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607241|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607242|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607243|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607244|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607245|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607246|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607247|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607248|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607249|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607250|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607251|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607252|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607411|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607412|NCT01001377|E2|Reported Event|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607253|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607254|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607255|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607256|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607257|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607258|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607259|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607260|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607261|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607262|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607263|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607264|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607265|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607266|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607267|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607268|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607269|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607270|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607271|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607272|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607273|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607274|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607275|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607413|NCT01001377|E1|Reported Event|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
619027|NCT01037244|O4|Outcome|Placebo|Placebo tablets
607276|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607277|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607278|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607279|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607280|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607281|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607282|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607283|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607284|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607285|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607286|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607287|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607288|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607289|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607290|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607291|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607292|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607293|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607294|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607295|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607296|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607297|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607298|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607544|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
607299|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607300|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607301|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607302|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607303|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607304|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607305|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607306|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607307|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607308|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607309|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607310|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607311|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607312|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607313|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607314|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607315|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607316|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607317|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607318|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607319|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607320|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607321|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607545|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
607322|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607323|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607324|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607325|NCT01001221|E4|Reported Event|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607326|NCT01001221|E3|Reported Event|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607327|NCT01001221|E2|Reported Event|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607328|NCT01001221|E1|Reported Event|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8
21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
607329|NCT01001234|B6|Baseline|Total|Total of all reporting groups
607330|NCT01001234|B5|Baseline|Rizatriptan/Placebo|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose).
607479|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
607331|NCT01001234|B4|Baseline|Placebo/Placebo|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
607332|NCT01001234|B3|Baseline|Placebo/Rizatriptan|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
607333|NCT01001234|B2|Baseline|Rizatriptan/NA|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
607334|NCT01001234|B1|Baseline|Placebo/NA|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
607335|NCT01001234|P5|Participant Flow|Rizatriptan/Placebo|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose).
607336|NCT01001234|P4|Participant Flow|Placebo/Placebo|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
607337|NCT01001234|P3|Participant Flow|Placebo/Rizatriptan|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
607338|NCT01001234|P2|Participant Flow|Rizatriptan/NA|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
607339|NCT01001234|P1|Participant Flow|Placebo/NA|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
607340|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
607341|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
607342|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
607343|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
607344|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
607350|NCT01001299|B1|Baseline|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607351|NCT01001299|P1|Participant Flow|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 milligrams [mg] tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 milligrams per kilogram [mg/kg] syrup) on Day 1, followed by 5-day washout. Vemurafenib (RO5185426) 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607352|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607353|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607354|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607355|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607356|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607357|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607358|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607359|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607414|NCT01001390|B1|Baseline|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
607604|NCT01007253|E4|Reported Event|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
607360|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607361|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607362|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607363|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607364|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607365|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607366|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607367|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607368|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607369|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607415|NCT01001390|P2|Participant Flow|Group 2: Without Then With AFO|Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
607605|NCT01007253|E3|Reported Event|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
607370|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607371|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607372|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607373|NCT01001299|E1|Reported Event|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
607378|NCT01001325|P1|Participant Flow|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
607379|NCT01001325|O2|Outcome|Placebo|0.5 mL normal saline
607380|NCT01001325|O1|Outcome|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
607381|NCT01001325|E2|Reported Event|Placebo|0.5 mL normal saline
607382|NCT01001325|E1|Reported Event|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
607383|NCT01001377|B3|Baseline|Total|Total of all reporting groups
607384|NCT01001377|B2|Baseline|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607385|NCT01001377|B1|Baseline|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607386|NCT01001377|P2|Participant Flow|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607387|NCT01001377|P1|Participant Flow|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607388|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607389|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607390|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607391|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607392|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607393|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607394|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607395|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607396|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607397|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607398|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607399|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607400|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607401|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607402|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607403|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607404|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607405|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607406|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607407|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607408|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
607409|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
607410|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
619028|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
607416|NCT01001390|P1|Participant Flow|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
607417|NCT01001390|O1|Outcome|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
607418|NCT01001390|O1|Outcome|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
607419|NCT01001390|E2|Reported Event|Group 2: Without Then With AFO|Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
607420|NCT01001390|E1|Reported Event|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
607421|NCT01001403|B3|Baseline|Total|Total of all reporting groups
607422|NCT01001403|B2|Baseline|Control|
607423|NCT01001403|B1|Baseline|Nafamostat|
607424|NCT01001403|P2|Participant Flow|Control|
607425|NCT01001403|P1|Participant Flow|Nafamostat|
607426|NCT01001403|O2|Outcome|Control|
607427|NCT01001403|O1|Outcome|Nafamostat|
607428|NCT01001403|E2|Reported Event|Control|
607429|NCT01001403|E1|Reported Event|Nafamostat|
607430|NCT01001429|B3|Baseline|Total|Total of all reporting groups
607431|NCT01001429|B2|Baseline|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.
Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
607432|NCT01001429|B1|Baseline|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min
propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
607480|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
611636|NCT01019928|O1|Outcome|AZD1386 95 mg|
607433|NCT01001429|P2|Participant Flow|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.
Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
607434|NCT01001429|P1|Participant Flow|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min
propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
607435|NCT01001429|O2|Outcome|Dexmedetomidine|heart rate recorded at at 30 min intervals while in PACU (2 hours)
607436|NCT01001429|O1|Outcome|Propofol Group|heart rate recorded in 30 min intervals in PACU ( 2 hours)
607437|NCT01001429|O4|Outcome|Dexmedetomidine|diastolic pressure measured every 30 min in PACU
607438|NCT01001429|O3|Outcome|Propofol|diastolic blood pressure recorded every 30 min in PACU
607439|NCT01001429|O2|Outcome|Dexmedetomidine Group|systolic blood pressure measured at 3 0 min. intervals in PACU
607440|NCT01001429|O1|Outcome|Propofol Group|systolic blood pressure at 30 min intervals in PACU
607441|NCT01001429|O2|Outcome|Dexmedetomidine Group|"patient satisfaction
1=very poor, 2=poor, 3=fair, 4= good, 5=excellent"
607442|NCT01001429|O1|Outcome|Propofol|patient satisfaction prior to discharge on a 5 point scale1=very poor, 2=poor, 3=fair, 4= good , 5=excellent
607443|NCT01001429|O2|Outcome|Dexmedetomidine Group|patients receiving study drug dexmedetomidine
607444|NCT01001429|O1|Outcome|Propofol Group|patients receiving comparison drug propofol
607445|NCT01001429|O2|Outcome|Dexmedetomidine Group|surgeon satisfaction at 10 minutes into the procedure
607446|NCT01001429|O1|Outcome|Propofol Group|surgeon satisfaction at 10 minutes in to the procedure for subjects randomized to propofol
607447|NCT01001429|O2|Outcome|Dexmedetomidine|Heart rate recorded at 5 minute interval for subjects randomized to dexmedetomidine
607448|NCT01001429|O1|Outcome|Propofol Group|Heart rate recorded at 5 minute intervals during procedure for subjects randomized to propofol
607449|NCT01001429|O2|Outcome|Dexmedetomidine Group|subjects randomized to dexmedetomidine group had their respiratory rate recorded at 5 minute intervals during the operative procedure
607450|NCT01001429|O1|Outcome|Propofol Group|subjects randomized to propofol group had their respiratory rate recorded at 5 minute intervals during the operative procedure.
607451|NCT01001429|O4|Outcome|Dexmedetomidine Group- Mean Diastolic Blood Pressure|dexmedetomidine as already described and blood pressure monitored 5 min intervals,
607452|NCT01001429|O3|Outcome|Propofol Group- Mean Diastolic Blood Pressure|propofol administered as described- blood pressure recorded at 5 min intervals during surgery
607453|NCT01001429|O2|Outcome|Dexmedetomidine Group-mean Systolic Blood Pressure|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.
Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
607454|NCT01001429|O1|Outcome|Propofol Group -Mean Systolic Blood Pressure|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min
propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
607455|NCT01001429|O2|Outcome|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.
Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
607456|NCT01001429|O1|Outcome|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min
propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
607457|NCT01001429|O4|Outcome|UMSS in Dexmedetomidine Infusion Group|subject received medication as described in BIS/dexmedetomidine
607459|NCT01001429|O2|Outcome|BIS Scores in Dexmedetomidine Infusion Group|"Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.
Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
607460|NCT01001429|O1|Outcome|BIS Scores in Propofol Infusion Group|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min
propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
607461|NCT01001429|E2|Reported Event|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.
Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
607462|NCT01001429|E1|Reported Event|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min
propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
607463|NCT01001494|B4|Baseline|Total|Total of all reporting groups
607464|NCT01001494|B3|Baseline|Placebo|Placebo via inhalation
607465|NCT01001494|B2|Baseline|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
607466|NCT01001494|B1|Baseline|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
607467|NCT01001494|P3|Participant Flow|Placebo|Placebo via inhalation
607468|NCT01001494|P2|Participant Flow|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
607469|NCT01001494|P1|Participant Flow|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
607470|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
607471|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
607472|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
607473|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
607474|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
607475|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
607476|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
607477|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
607478|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
607483|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
607484|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
607485|NCT01001494|E3|Reported Event|Placebo|Placebo via inhalation
607486|NCT01001494|E2|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
607487|NCT01001494|E1|Reported Event|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
607488|NCT01001520|B1|Baseline|Entire Study Population|Includes all subjects who were randomized to both study treatment groups (i.e., receive both placebo first and tolcapone first) and initiated study medication.
607489|NCT01001520|P2|Participant Flow|Tolcapone First, Then Placebo|"Subjects were asked to take study medication each day during two 11-day study medication periods. Between the two study medication periods was a washout period (no medication or visits) that lasted at least 10 days. During this washout period, subjects did not take any study medication and were asked to return to their normal smoking levels.
Study medication assignment for each subject was randomized and counterbalanced, meaning approximately 50% of subjects took tolcapone during the first medication period, followed by a placebo during the second medication period.
During the active tolcapone medication period, subjects followed a tapered dosing schedule (see protocol section for complete description)."
607490|NCT01001520|P1|Participant Flow|Placebo First, Then Tolcapone|"Subjects were asked to take study medication each day during two 11-day study medication periods. Between the two study medication periods was a washout period (no medication or visits) that lasted at least 10 days. During this washout period, subjects did not take any study medication and were asked to return to their normal smoking levels.
Study medication assignment for each subject was randomized and counterbalanced, meaning approximately 50% of subjects took placebo during the first medication period, followed by tolcapone during the second medication period.
During the placebo medication period, subjects followed a medication regimen and took capsules that were identical to those in the active tolcapone medication period (see protocol section for complete description)."
607491|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607492|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.
Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607493|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607546|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
607494|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.
Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607495|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607496|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.
Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607497|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607498|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.
Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607499|NCT01001520|O2|Outcome|Tolcapone|"See Protocol or Participant Flow sections for full description of this study arm."
607500|NCT01001520|O1|Outcome|Placebo|"See Protocol or Participant Flow sections for full description of this study arm."
607501|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607518|NCT01001546|O2|Outcome|Control|"Clinic-based smoking cessation
Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
607502|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.
Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607503|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607504|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.
Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607505|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607506|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.
Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607507|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607508|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.
Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607509|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)"
607547|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
607548|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
607510|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.
Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.
All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
607511|NCT01001520|E2|Reported Event|Tolcapone|"11-day phase, tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily); oral dosing; medication is encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)
Tolcapone: Participants will be asked to take study medication each day for both 11-day study medication periods.
The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
607512|NCT01001520|E1|Reported Event|Placebo|"11-day placebo-controlled medication period. Placebo capsules are identical to those in the active tolcapone treatment. When taking placebo, subjects follow an identical dosing schedule as the active treatment period.
Placebo: Participants will be asked to take study medication each day for both 11-day study medication periods.
The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
607513|NCT01001546|B3|Baseline|Total|Total of all reporting groups
607514|NCT01001546|B2|Baseline|Control|"Clinic-based smoking cessation
Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
607515|NCT01001546|B1|Baseline|Intervention|"Internet-based smoking cessation
Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
607516|NCT01001546|P2|Participant Flow|Control|"Clinic-based smoking cessation
Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
607517|NCT01001546|P1|Participant Flow|Intervention|"Internet-based smoking cessation
Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
607519|NCT01001546|O1|Outcome|Intervention|"Internet-based smoking cessation
Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
607520|NCT01001546|E2|Reported Event|Control|"Clinic-based smoking cessation
Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
607521|NCT01001546|E1|Reported Event|Intervention|"Internet-based smoking cessation
Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
607522|NCT01001559|B3|Baseline|Total|Total of all reporting groups
607523|NCT01001559|B2|Baseline|Antidepressant Alone|SSRI or SNRI alone
607524|NCT01001559|B1|Baseline|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
607525|NCT01001559|P2|Participant Flow|Antidepressant Alone|SSRI or SNRI alone
607526|NCT01001559|P1|Participant Flow|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
607527|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
607528|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
607529|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
607530|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
607531|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
607532|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
607533|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
607534|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
607535|NCT01001559|E2|Reported Event|Antidepressant Alone|SSRI or SNRI alone
607536|NCT01001559|E1|Reported Event|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
607537|NCT01001572|B3|Baseline|Total|Total of all reporting groups
607538|NCT01001572|B2|Baseline|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
607539|NCT01001572|B1|Baseline|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
607540|NCT01001572|P3|Participant Flow|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
607541|NCT01001572|P2|Participant Flow|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
607542|NCT01001572|P1|Participant Flow|Single-Blind Run -In Valsartan 160 mg|Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.
619029|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
607549|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
607550|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
607551|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
607552|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
607553|NCT01001572|E2|Reported Event|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
607554|NCT01001572|E1|Reported Event|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
607555|NCT01001702|B1|Baseline|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
607556|NCT01001702|P1|Participant Flow|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
607557|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
607558|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
607559|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
607560|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
607561|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
607562|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
607563|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
607564|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
607565|NCT01001702|E1|Reported Event|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
607566|NCT01001767|B3|Baseline|Total|Total of all reporting groups
607567|NCT01001767|B2|Baseline|Placebo|Placebo capsule by mouth twice a day x 24 weeks
607568|NCT01001767|B1|Baseline|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
607569|NCT01001767|P2|Participant Flow|Placebo|Placebo capsule by mouth twice a day x 24 weeks
611637|NCT01019928|O2|Outcome|Placebo|
607571|NCT01001767|O2|Outcome|Placebo|Placebo capsule by mouth twice a day x 24 weeks
607572|NCT01001767|O1|Outcome|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
607573|NCT01001767|E2|Reported Event|Placebo|Placebo capsule by mouth twice a day x 24 weeks
607574|NCT01001767|E1|Reported Event|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
607575|NCT01007253|B1|Baseline|Entire Study Population|Includes groups randomized to receive PL/PL first, FF/PL first, PL/OLO first, and FF/OLO first.
607576|NCT01007253|P4|Participant Flow|PL/PL, FF/PL, PL/OLO, FF/OLO|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:
placebo (PL) nasal spray and PL eye drops (PL/PL),
fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL),
PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), and
FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO)."
607577|NCT01007253|P3|Participant Flow|FF/OLO, PL/PL, FF/PL, PL/OLO|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:
FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),
placebo (PL) nasal spray and PL eye drops (PL/PL),
fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL), and
PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO)."
607578|NCT01007253|P2|Participant Flow|PL/OLO, FF/OLO, PL/PL, FF/PL|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:
PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),
FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),
placebo (PL) nasal spray and PL eye drops (PL/PL), and
fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)."
607579|NCT01007253|P1|Participant Flow|FF/PL, PL/OLO, FF/OLO, PL/PL|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:
fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)
PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),
FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), and
placebo (PL) nasal spray and PL eye drops (PL/PL)."
607580|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
607581|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
607582|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
607583|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
607584|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
607585|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
607586|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
607587|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
607588|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
607589|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
607590|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
607591|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
607592|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
607593|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
607606|NCT01007253|E2|Reported Event|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
607607|NCT01007253|E1|Reported Event|PL/PL|placebo (PL) nasal spray and PL eye drops
607608|NCT01007396|B1|Baseline|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.
After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
607609|NCT01007396|P1|Participant Flow|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.
After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
607610|NCT01007396|O1|Outcome|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.
After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
607611|NCT01007396|O1|Outcome|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.
After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
607612|NCT01007396|E1|Reported Event|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.
After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
607613|NCT01007435|B5|Baseline|Total|Total of all reporting groups
607614|NCT01007435|B4|Baseline|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607615|NCT01007435|B3|Baseline|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607616|NCT01007435|B2|Baseline|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607617|NCT01007435|B1|Baseline|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607618|NCT01007435|P4|Participant Flow|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607619|NCT01007435|P3|Participant Flow|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607620|NCT01007435|P2|Participant Flow|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607621|NCT01007435|P1|Participant Flow|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607622|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607623|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607624|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607625|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607626|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607627|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607628|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607629|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607630|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607631|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607632|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607633|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607634|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607635|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607636|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607637|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607638|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607639|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607640|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607641|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607642|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607643|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607644|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607645|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607646|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607647|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607648|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607649|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607650|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607651|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607652|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607653|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607654|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607655|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607656|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607657|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607658|NCT01007435|E4|Reported Event|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
607659|NCT01007435|E3|Reported Event|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607660|NCT01007435|E2|Reported Event|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
607661|NCT01007435|E1|Reported Event|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
607662|NCT01013597|B1|Baseline|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
607663|NCT01013597|P1|Participant Flow|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
607664|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
607665|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
607666|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
607667|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
607668|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
607669|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
607670|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
607671|NCT01013597|E1|Reported Event|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
607672|NCT01013740|B3|Baseline|Total|Total of all reporting groups
607673|NCT01013740|B2|Baseline|Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
607674|NCT01013740|B1|Baseline|Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
607675|NCT01013740|P2|Participant Flow|Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
619030|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
607676|NCT01013740|P1|Participant Flow|Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
607677|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
607678|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
607679|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
607680|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
607681|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
607747|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607748|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607682|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
607683|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
607684|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
607685|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
607686|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
607687|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
607688|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
607689|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
607690|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
607691|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
607692|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
607693|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
607694|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
607695|NCT01013740|E4|Reported Event|Crossover Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2|Crossover phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
607696|NCT01013740|E3|Reported Event|Crossover Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2|Crossover phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
607697|NCT01013740|E2|Reported Event|Randomized Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2|Randomized phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
607698|NCT01013740|E1|Reported Event|Randomized Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2|Randomized phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
607699|NCT01013753|B1|Baseline|Study Total|This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
607700|NCT01013753|P1|Participant Flow|Study Total|This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
607701|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607702|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607703|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607704|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607705|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607706|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607707|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607708|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607709|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607710|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607711|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607712|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607713|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607714|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607715|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607716|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607717|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607718|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607719|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607720|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607721|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607722|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607723|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607724|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607725|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607726|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607727|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607728|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607729|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607730|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607731|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607732|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607733|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607734|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607735|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607736|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607737|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607738|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607739|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607740|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607741|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607742|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607743|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607744|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607745|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607746|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607749|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607750|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607751|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607752|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607753|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607754|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607755|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607756|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607757|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607758|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607759|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607760|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607761|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607762|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607763|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607764|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607765|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607766|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607767|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607768|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607769|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607770|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607771|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607772|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607773|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607774|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607775|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607776|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607777|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607778|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607779|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607780|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607781|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607782|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607783|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607784|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607785|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607786|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607787|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607788|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607789|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607790|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607791|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607792|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607793|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607794|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607795|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607796|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607797|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607798|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
611638|NCT01019928|O1|Outcome|AZD1386 95 mg|
607799|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607800|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607801|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607802|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607803|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607804|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607805|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607806|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607807|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607808|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607809|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607810|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607811|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607812|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607813|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607814|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607815|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607816|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607817|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607818|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607819|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607820|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607821|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607822|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607823|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607824|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607825|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607826|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607827|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607828|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607829|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607830|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607831|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607832|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607833|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607834|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607835|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607836|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607837|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607838|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607839|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607840|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607841|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607842|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607843|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607844|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607845|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607846|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607847|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607848|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
611639|NCT01019928|O2|Outcome|Placebo|
607849|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607850|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607851|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607852|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607853|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607854|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607855|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607856|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607857|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607858|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607859|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607860|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607861|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607862|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607863|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607864|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607865|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607866|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607867|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607868|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607869|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607870|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607871|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607872|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607873|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607874|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607875|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
619031|NCT01037244|O4|Outcome|Placebo|Placebo tablets
607876|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607877|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607878|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607879|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607880|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607881|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607882|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607883|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607884|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607885|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607886|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607887|NCT01013753|E6|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
607888|NCT01013753|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607889|NCT01013753|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607890|NCT01013753|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607891|NCT01013753|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
607892|NCT01013753|E1|Reported Event|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
607893|NCT01013792|B3|Baseline|Total|Total of all reporting groups
607894|NCT01013792|B2|Baseline|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
607895|NCT01013792|B1|Baseline|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
607896|NCT01013792|P2|Participant Flow|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
607897|NCT01013792|P1|Participant Flow|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
609522|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
607898|NCT01013792|O2|Outcome|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
607899|NCT01013792|O1|Outcome|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
607900|NCT01013792|E2|Reported Event|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
607901|NCT01013792|E1|Reported Event|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
607902|NCT01013844|B3|Baseline|Total|Total of all reporting groups
607903|NCT01013844|B2|Baseline|Dyadic Learning|Participant and partner learning together.
607904|NCT01013844|B1|Baseline|Solo Learning|Participant learning alone (without partner).
607905|NCT01013844|P2|Participant Flow|Dyadic Learning|Participant and partner learning together.
607906|NCT01013844|P1|Participant Flow|Solo Learning|Participant learning alone (without partner).
607907|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
607908|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
607909|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
607910|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
607911|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
607912|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
607913|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
607914|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
607915|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
607916|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
607917|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
607918|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
607919|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
607920|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
607921|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
607922|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
607923|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
607924|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
607925|NCT01013844|E2|Reported Event|Dyadic Learning|Participant and partner learning together.
607926|NCT01013844|E1|Reported Event|Solo Learning|Participant learning alone (without partner).
607927|NCT01013870|B3|Baseline|Total|Total of all reporting groups
607928|NCT01013870|B2|Baseline|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
619032|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
607929|NCT01013870|B1|Baseline|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
607930|NCT01013870|P2|Participant Flow|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
607931|NCT01013870|P1|Participant Flow|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
607932|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
607933|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
607934|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
607935|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
607936|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
607963|NCT01013883|E2|Reported Event|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
607937|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
607938|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
607939|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
607940|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
607941|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
607942|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
607943|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
607944|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
607945|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
607946|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
607947|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
619033|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
607948|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
607949|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
607950|NCT01013870|E2|Reported Event|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
607951|NCT01013870|E1|Reported Event|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
607952|NCT01013883|B3|Baseline|Total|Total of all reporting groups
607953|NCT01013883|B2|Baseline|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
607954|NCT01013883|B1|Baseline|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
607955|NCT01013883|P2|Participant Flow|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
607956|NCT01013883|P1|Participant Flow|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
607957|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
607958|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
607959|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
607960|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
607961|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
607962|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
607964|NCT01013883|E1|Reported Event|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
607965|NCT01013961|B3|Baseline|Total|Total of all reporting groups
607966|NCT01013961|B2|Baseline|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607967|NCT01013961|B1|Baseline|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607968|NCT01013961|P2|Participant Flow|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607969|NCT01013961|P1|Participant Flow|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607970|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607971|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
608341|NCT01014741|B1|Baseline|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
619034|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
607972|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607973|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607974|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607975|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607976|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
609528|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
607977|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607978|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607979|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607980|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607981|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607982|NCT01013961|E2|Reported Event|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
608005|NCT01014091|P5|Participant Flow|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608252|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
607983|NCT01013961|E1|Reported Event|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.
Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
607984|NCT01014013|B3|Baseline|Total|Total of all reporting groups
607985|NCT01014013|B2|Baseline|Ceftriaxone|A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
607986|NCT01014013|B1|Baseline|MK0826|A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
607987|NCT01014013|P2|Participant Flow|Ceftriaxone|A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
607988|NCT01014013|P1|Participant Flow|MK0826|A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
607989|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
607990|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.
608086|NCT01014143|P3|Participant Flow|Chlorhexidine Oral Rinse First|chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
607991|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
607992|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
607993|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
607994|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.
607995|NCT01014013|E2|Reported Event|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
607996|NCT01014013|E1|Reported Event|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
607997|NCT01014091|B7|Baseline|Total|Total of all reporting groups
607998|NCT01014091|B6|Baseline|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
607999|NCT01014091|B5|Baseline|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608000|NCT01014091|B4|Baseline|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608001|NCT01014091|B3|Baseline|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608002|NCT01014091|B2|Baseline|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608003|NCT01014091|B1|Baseline|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608004|NCT01014091|P6|Participant Flow|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608143|NCT01014442|B3|Baseline|Total|Total of all reporting groups
619035|NCT01037244|E4|Reported Event|Placebo|Placebo tablets
608006|NCT01014091|P4|Participant Flow|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608007|NCT01014091|P3|Participant Flow|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608008|NCT01014091|P2|Participant Flow|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608009|NCT01014091|P1|Participant Flow|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608010|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608011|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608012|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608013|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608087|NCT01014143|P2|Participant Flow|Total Toothpaste First|triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
611640|NCT01019928|O1|Outcome|AZD1386 95 mg|
608014|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608015|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608016|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608017|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608018|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608019|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608020|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608021|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608022|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608023|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608024|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608025|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608026|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608027|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608028|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
609513|NCT01018030|P3|Participant Flow|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
608029|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608030|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608031|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608032|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608033|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608034|NCT01014091|O3|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608035|NCT01014091|O2|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608036|NCT01014091|O1|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608037|NCT01014091|O3|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608038|NCT01014091|O2|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608039|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608040|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608041|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608042|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608043|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608044|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608045|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608046|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608047|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608048|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608049|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608050|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608051|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608286|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
608052|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608053|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608054|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608055|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608056|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608057|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608058|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608059|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
610609|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
608060|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608061|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608062|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608063|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608064|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608065|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608066|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608067|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608068|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608069|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608070|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608071|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608072|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608073|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608074|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608075|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608342|NCT01014741|P2|Participant Flow|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
608076|NCT01014091|E6|Reported Event|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608077|NCT01014091|E5|Reported Event|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
608078|NCT01014091|E4|Reported Event|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608079|NCT01014091|E3|Reported Event|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
608080|NCT01014091|E2|Reported Event|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608081|NCT01014091|E1|Reported Event|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
608082|NCT01014143|B4|Baseline|Total|Total of all reporting groups
608083|NCT01014143|B3|Baseline|Chlorhexidine Oral Rinse|chlorhexidine mouthrinse (positive control rinse)
608084|NCT01014143|B2|Baseline|Total Toothpaste|triclosan/fluoride toothpaste (positive control toothpaste)
608085|NCT01014143|B1|Baseline|Fluoride Toothpaste|negative control
609094|NCT01015170|B1|Baseline|Buproprion & Behavioural Support|8 weeks of buproprion-SR + brief counselling for smoking cessation
608088|NCT01014143|P1|Participant Flow|Fluoride Toothpaste First|Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
608089|NCT01014143|O3|Outcome|Chlorhexidine Oral Rinse|chlorhexidine mouthrinse (positive control rinse)
608090|NCT01014143|O2|Outcome|Total Toothpaste|triclosan/fluoride toothpaste (positive control toothpaste)
608091|NCT01014143|O1|Outcome|Fluoride Toothpaste|negative control
608092|NCT01014143|E3|Reported Event|Chlorhexidine Oral Rinse First|chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
608093|NCT01014143|E2|Reported Event|Total Toothpaste First|triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
608094|NCT01014143|E1|Reported Event|Fluoride Toothpaste First|Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
608095|NCT01014169|B3|Baseline|Total|Total of all reporting groups
608096|NCT01014169|B2|Baseline|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
608097|NCT01014169|B1|Baseline|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
608098|NCT01014169|P2|Participant Flow|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
608099|NCT01014169|P1|Participant Flow|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
608100|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
608101|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
608102|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
608103|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
608104|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
608105|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
608106|NCT01014169|E2|Reported Event|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
608107|NCT01014169|E1|Reported Event|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
608108|NCT01014208|B3|Baseline|Total|Total of all reporting groups
608144|NCT01014442|B2|Baseline|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608109|NCT01014208|B2|Baseline|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608110|NCT01014208|B1|Baseline|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608111|NCT01014208|P2|Participant Flow|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608112|NCT01014208|P1|Participant Flow|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608113|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608114|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608115|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608145|NCT01014442|B1|Baseline|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608146|NCT01014442|P2|Participant Flow|MMF - COPD, Emphysema, IPF, or A1AD|Participants with chronic obstructive pulmonary disorder (COPD), emphysema, idiopathic pulmonary fibrosis (IPF), or alpha-1 antitrypsin deficiency (A1AD) having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608287|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
608116|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608117|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608154|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
608155|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608156|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
608407|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608118|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608119|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608120|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608121|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608122|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608123|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608124|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608125|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608126|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608127|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608128|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608129|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608130|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608131|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608132|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608133|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608134|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608135|NCT01014208|E2|Reported Event|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608136|NCT01014208|E1|Reported Event|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
608137|NCT01014351|B1|Baseline|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
608138|NCT01014351|P1|Participant Flow|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
608139|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
608140|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
608141|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
608142|NCT01014351|E1|Reported Event|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
608147|NCT01014442|P1|Participant Flow|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received mycophenolate mofetil (MMF) capsules at dose of 1.5 grams (g) twice daily (BID) from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608148|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
608149|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608150|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
608151|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608152|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
608153|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608157|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608158|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608159|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608160|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608161|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608162|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608163|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608164|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608165|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608166|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608167|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608168|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608169|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608170|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608171|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608172|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608173|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608174|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608175|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608176|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608177|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608178|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608179|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608180|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608181|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608182|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608304|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
611641|NCT01019928|O2|Outcome|Placebo|
608183|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608184|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608185|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608186|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608187|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608188|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608189|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608190|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608191|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608192|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608193|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608194|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608195|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608196|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608197|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608198|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608199|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608339|NCT01014741|B3|Baseline|Total|Total of all reporting groups
608200|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608201|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608202|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608203|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608204|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608205|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608206|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608207|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608208|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608209|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608210|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608211|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608212|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608213|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608214|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608215|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608216|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608217|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608218|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608219|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608220|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608221|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608222|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608223|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608224|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608225|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
619036|NCT01037244|E3|Reported Event|Udenafil 150mg|Udenafil 150mg tablets
608226|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608227|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608228|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608229|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608230|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608231|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608232|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608233|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608305|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
608306|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
608307|NCT01014624|O2|Outcome|Clopidogrel|Clopidogrel 75 mg tablet daily
608234|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608235|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608236|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608237|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608238|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608239|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608240|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608241|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608242|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608243|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608244|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608245|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608246|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608247|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608248|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608249|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608250|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608251|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608253|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608254|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608255|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608256|NCT01014442|E2|Reported Event|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
608257|NCT01014442|E1|Reported Event|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
608258|NCT01014455|B3|Baseline|Total|Total of all reporting groups
608259|NCT01014455|B2|Baseline|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
608260|NCT01014455|B1|Baseline|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
608261|NCT01014455|P2|Participant Flow|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
608308|NCT01014624|O1|Outcome|Prasugrel|Prasugrel 10 mg tablet daily
608309|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
608310|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
608262|NCT01014455|P1|Participant Flow|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
608263|NCT01014455|O2|Outcome|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
608264|NCT01014455|O1|Outcome|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
608265|NCT01014455|E2|Reported Event|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
608266|NCT01014455|E1|Reported Event|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
608267|NCT01014585|B5|Baseline|Total|Total of all reporting groups
608268|NCT01014585|B4|Baseline|Non-Responders: Milnacipran (Milnacipran Continued)|"Safety Population for Non-Responders: milnacipran treatment assignment
One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double-blind investigational product and therefore was not included in the Safety population."
608269|NCT01014585|B3|Baseline|Non-Responders: Placebo (Milnacipran Withdrawn)|Safety Population for Non-Responders: placebo treatment assignment
608270|NCT01014585|B2|Baseline|Responders: Milnacipran (Milnacipran Continued)|Safety Population for Responders: milnacipran treatment assignment
608271|NCT01014585|B1|Baseline|Responders: Placebo (Milnacipran Withdrawn)|"Safety Population for Responders: placebo treatment assignment
One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population."
608272|NCT01014585|P4|Participant Flow|Non-Responders: Milnacipran (Milnacipran Continued)|The Randomized Population for Non-Responders
608273|NCT01014585|P3|Participant Flow|Non-Responders: Placebo (Milnacipran Withdrawn)|The Randomized Population for Non-Responders
608274|NCT01014585|P2|Participant Flow|Responders: Milnacipran (Milnacipran Continued)|The Randomized Population for Responders
608275|NCT01014585|P1|Participant Flow|Responders: Placebo (Milnacipran Withdrawn)|The Randomized Population for Responders
608276|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
608277|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
608278|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
608279|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
608280|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
608281|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
608282|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
608283|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
608284|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
608285|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
608340|NCT01014741|B2|Baseline|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
622739|NCT01042145|B3|Baseline|Total|Total of all reporting groups
608288|NCT01014585|E4|Reported Event|Non-Responders: Milnacipran (Milnacipran Continued)|"Safety Population for Non-Responders: milnacipran treatment assignment
One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double blind investigational product and therefore was not included in the Safety population."
608289|NCT01014585|E3|Reported Event|Non-Responders: Placebo (Milnacipran Withdrawn)|Safety Population for Non-Responders: placebo treatment assignment
608290|NCT01014585|E2|Reported Event|Responders: Milnacipran (Milnacipran Continued)|Safety Population for Responders: milnacipran treatment assignment
608291|NCT01014585|E1|Reported Event|Responders: Placebo (Milnacipran Withdrawn)|"Safety Population for Responders: placebo treatment assignment
One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population."
608292|NCT01014624|B3|Baseline|Total|Total of all reporting groups
608293|NCT01014624|B2|Baseline|Clopidogrel|Clopidogrel 75 mg tablet daily
608294|NCT01014624|B1|Baseline|Prasugrel|Prasugrel 10 mg tablet daily
608295|NCT01014624|P2|Participant Flow|Clopidogrel|Clopidogrel 75 mg daily
608296|NCT01014624|P1|Participant Flow|Prasugrel|Prasugrel 10 mg daily
608297|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
608298|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
608299|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
608300|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
608301|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
608302|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
608303|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
608316|NCT01014689|B2|Baseline|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
608317|NCT01014689|B1|Baseline|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
608318|NCT01014689|P2|Participant Flow|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
608319|NCT01014689|P1|Participant Flow|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
608320|NCT01014689|O2|Outcome|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
608321|NCT01014689|O1|Outcome|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
608322|NCT01014689|O2|Outcome|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
608323|NCT01014689|O1|Outcome|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
608324|NCT01014689|E2|Reported Event|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
608325|NCT01014689|E1|Reported Event|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
608326|NCT01014728|B3|Baseline|Total|Total of all reporting groups
608327|NCT01014728|B2|Baseline|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
608328|NCT01014728|B1|Baseline|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
608329|NCT01014728|P2|Participant Flow|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
608330|NCT01014728|P1|Participant Flow|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
608331|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
608332|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
608333|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
608334|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
608335|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
608336|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
608337|NCT01014728|E2|Reported Event|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
608338|NCT01014728|E1|Reported Event|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
608343|NCT01014741|P1|Participant Flow|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after pulmonary vein isolation (PVI) isolation prior to complex fractionated atrial electrograms (CFAE) ablation
608344|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
608345|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
608346|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
608347|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
608348|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
608349|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
608350|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
608351|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
608352|NCT01014741|E2|Reported Event|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
608353|NCT01014741|E1|Reported Event|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
608354|NCT01014871|B1|Baseline|Vistabel/Azzalure|"at Baseline:
1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead
1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
608355|NCT01014871|P1|Participant Flow|Vistabel/Azzalure|"at Baseline:
1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead
1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
608356|NCT01014871|O2|Outcome|Vistabel|"at Baseline:
- 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
608357|NCT01014871|O1|Outcome|Azzalure|"at Baseline:
- 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead"
608358|NCT01014871|E2|Reported Event|Vistabel|intra-individual comparison
608359|NCT01014871|E1|Reported Event|Azzalure|intra-individual comparison
608360|NCT01014910|B3|Baseline|Total|Total of all reporting groups
608374|NCT01014936|B1|Baseline|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
610610|NCT01010971|O3|Outcome|Placebo|Placebo once daily
608361|NCT01014910|B2|Baseline|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.
Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
608362|NCT01014910|B1|Baseline|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
608363|NCT01014910|P2|Participant Flow|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.
Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
608364|NCT01014910|P1|Participant Flow|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
608365|NCT01014910|O2|Outcome|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.
Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
608366|NCT01014910|O1|Outcome|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
608367|NCT01014910|O2|Outcome|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.
Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
608368|NCT01014910|O1|Outcome|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
608369|NCT01014910|E2|Reported Event|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.
Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
608370|NCT01014910|E1|Reported Event|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
608371|NCT01014936|B4|Baseline|Total|Total of all reporting groups
608372|NCT01014936|B3|Baseline|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608373|NCT01014936|B2|Baseline|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608406|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608375|NCT01014936|P3|Participant Flow|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608376|NCT01014936|P2|Participant Flow|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608377|NCT01014936|P1|Participant Flow|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
608378|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608379|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608380|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
608381|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608382|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608383|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
608384|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608385|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608386|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
608387|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608388|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608389|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
608390|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608391|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608434|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
622740|NCT01042145|B2|Baseline|Dexamethasone|
608392|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
608393|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608394|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608395|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
608396|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608397|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608398|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608399|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608400|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608401|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608402|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608403|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608404|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608405|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608408|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608409|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608410|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608411|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608412|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608413|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608414|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608415|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608416|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608417|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608418|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608419|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608420|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608421|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608422|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608423|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608424|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608425|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608426|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
608427|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608428|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608429|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608430|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608431|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608432|NCT01014936|O9|Outcome|MSC2156119J 115 mg Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608433|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608435|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608436|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608437|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608438|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608439|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608440|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608441|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608442|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608443|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608444|NCT01014936|O9|Outcome|MSC2156119J 60 mg Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608445|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608446|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608447|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608448|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608449|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608450|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608451|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608452|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
611642|NCT01019928|O1|Outcome|AZD1386 95 mg|
608453|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608454|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608455|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608456|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608457|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608458|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608459|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608460|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608461|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608462|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608463|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608464|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608465|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608466|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608467|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608468|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608469|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608470|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608471|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608472|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608473|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608474|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608475|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608476|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608477|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608478|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
622741|NCT01042145|B1|Baseline|Prednisone|
608479|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608480|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608481|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608482|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608483|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
608484|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608485|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608486|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608487|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608488|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608489|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608490|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608491|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608492|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608493|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608494|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608495|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608715|NCT01014936|O3|Outcome|MSC2156119J 500 mg Fed|Subjects were administered with micronized MSC2156119J 500 mg with food.
608496|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608497|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608498|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608499|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608500|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608501|NCT01014936|O9|Outcome|MSC2156119J 60 mg Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608502|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608503|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608504|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608505|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608506|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608507|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608508|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608509|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608510|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608511|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608512|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
608513|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608514|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608515|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608516|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608517|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608518|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608519|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608520|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608521|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608522|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608523|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608524|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608525|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608526|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608527|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608528|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608529|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608530|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608531|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608532|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608533|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608534|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608535|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608536|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608537|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608538|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608539|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
611643|NCT01019928|O2|Outcome|Placebo|
608540|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608541|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608542|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608543|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608544|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608545|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608546|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608547|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608548|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608549|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608550|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608551|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608552|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608553|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608554|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608555|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608556|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608557|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608558|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608559|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608560|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608561|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608562|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608563|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608564|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608565|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608566|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
622742|NCT01042145|P2|Participant Flow|Dexamethasone|
608567|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608568|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608569|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
608570|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608571|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608572|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608573|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608574|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608575|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608576|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608577|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608578|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608579|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608580|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608581|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608582|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608716|NCT01014936|O2|Outcome|MSC2156119J 500 mg Fasted|Subjects were administered with micronized MSC2156119J 500 mg in the fasted state.
608583|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608584|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608585|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608586|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608587|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608588|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608589|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608590|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608591|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608592|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608593|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608594|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608595|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608596|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (Tablet) with food.
608597|NCT01014936|O7|Outcome|MSC2156119J 1400 mg Fed|Subjects were administered with micronized MSC2156119J 1400 mg with food.
608598|NCT01014936|O6|Outcome|MSC2156119J 1200 mg Fasted|Subjects were administered with micronized MSC2156119J 1200 mg in the fasted state.
608599|NCT01014936|O5|Outcome|MSC2156119J 1000 mg Fed|Subjects were administered with micronized MSC2156119J 1000 mg with food.
608600|NCT01014936|O4|Outcome|MSC2156119J 700 mg Fed|Subjects were administered with micronized MSC2156119J 700 mg with food.
608601|NCT01014936|O3|Outcome|MSC2156119J 500 mg Fed|Subjects were administered with micronized MSC2156119J 500 mg with food
608602|NCT01014936|O2|Outcome|MSC2156119J 500 mg Fasted|Subjects were administered with micronized MSC2156119J 500 mg in the fasted state.
608603|NCT01014936|O1|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg with food
608604|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608605|NCT01014936|O8|Outcome|MSC2156119J 115 mg Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608606|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608607|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608608|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608609|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608610|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608611|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608612|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608613|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608614|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608615|NCT01014936|O10|Outcome|MSC2156119J 115 mg Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608616|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608617|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608618|NCT01014936|O7|Outcome|MSC2156119J 400 mg Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608619|NCT01014936|O6|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608620|NCT01014936|O5|Outcome|MSC2156119J 215 mg Fed|Subjects were administered with micronized MSC2156119J 215 mg with food.
608621|NCT01014936|O4|Outcome|MSC2156119J 145 mg Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608622|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608623|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608624|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608625|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608626|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608627|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
611644|NCT01019928|O1|Outcome|AZD1386 95 mg|
608628|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608629|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608630|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608631|NCT01014936|O1|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608632|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608633|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608634|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608635|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608636|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608637|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608638|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608639|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608640|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608641|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608642|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608643|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608644|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608645|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608646|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608647|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608648|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608649|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608650|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608651|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608652|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608653|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608654|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608655|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
622743|NCT01042145|P1|Participant Flow|Prednisone|
608656|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608657|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608658|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608659|NCT01014936|O2|Outcome|MSC2156119J 500 mg Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608660|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608661|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608662|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608663|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608664|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608665|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608666|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608667|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608668|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608669|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608670|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608717|NCT01014936|O1|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg with food.
608671|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608672|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608673|NCT01014936|O9|Outcome|MSC2156119J 60 mg Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg in the fasted state.
608674|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608675|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608676|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608677|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608678|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608679|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608680|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608681|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608682|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608683|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608684|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608685|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608686|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608687|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608688|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608689|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608690|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608691|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608692|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608693|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608694|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608695|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608696|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608697|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608698|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608699|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
622744|NCT01042145|O2|Outcome|Dexamethasone|
608700|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608701|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608702|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608703|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608704|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608705|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608706|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608707|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608708|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608709|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food
608710|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet) with food.
608711|NCT01014936|O7|Outcome|MSC2156119J 1400 mg Fed|Subjects were administered with micronized MSC2156119J 1400 mg with food.
608712|NCT01014936|O6|Outcome|MSC2156119J 1200 mg Fasted|Subjects were administered with micronized MSC2156119J 1200 mg in the fasted state.
608713|NCT01014936|O5|Outcome|MSC2156119J 1000 mg Fed|Subjects were administered with micronized MSC2156119J 1000 mg with food.
608714|NCT01014936|O4|Outcome|MSC2156119J 700 mg Fed|Subjects were administered with micronized MSC2156119J 700 mg with food.
610611|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
608718|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608719|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608720|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608721|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608722|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608723|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608724|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608725|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608726|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608727|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608728|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608729|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608730|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608731|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state
608732|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608733|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608734|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608735|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608736|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608737|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608738|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608739|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608740|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608741|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608742|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608743|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608744|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
622745|NCT01042145|O1|Outcome|Prednisone|
608745|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608746|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608747|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608748|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608749|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608750|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608751|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608752|NCT01014936|O3|Outcome|MSC2156119J 130 mg Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608753|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608754|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608755|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608756|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608757|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608758|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608759|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608760|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
610612|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
608761|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608762|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608763|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608764|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608765|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608766|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608767|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608768|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608769|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
608770|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608771|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608772|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608773|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608774|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608775|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608776|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608777|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608778|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608779|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608780|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608781|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608782|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608783|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608784|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608785|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608786|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608787|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608788|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608789|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608790|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608791|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608792|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608793|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608794|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608795|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608796|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608797|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608798|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608799|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608800|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608801|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608802|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608803|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608804|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
610613|NCT01010971|O3|Outcome|Placebo|Placebo once daily
608805|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608806|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608807|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608808|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608809|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608810|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608811|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608812|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608813|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608814|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608815|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608816|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608817|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608818|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608819|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608820|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608821|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608822|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608823|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608824|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
608825|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
608826|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
608827|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
608828|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
608829|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
608830|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
608831|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
608832|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
622746|NCT01042145|O2|Outcome|Dexamethasone|
608833|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608834|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608835|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608836|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
608837|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
608838|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
608839|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608840|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608841|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
608842|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
608843|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
608844|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
608845|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
608846|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
608847|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
610614|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
608848|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
608849|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
608850|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
608851|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
608852|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
608853|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608854|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608855|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
608856|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608857|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608858|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
608859|NCT01014936|O1|Outcome|MSC2156119J Combined|All subjects who were administered with micronized or non-micronized MSC2156119J (capsule or tablet formulation) in any of the three regimens.
608860|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608861|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608862|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
608863|NCT01014936|E3|Reported Event|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
608864|NCT01014936|E2|Reported Event|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
608865|NCT01014936|E1|Reported Event|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
608866|NCT01014975|B1|Baseline|Safety Population|Plasmin (Human): Plasmin (Human), 20 mg, 40 mg, or 80 mg, delivered through a catheter into a thrombus
608867|NCT01014975|P3|Participant Flow|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)
Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
608868|NCT01014975|P2|Participant Flow|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)
Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
608869|NCT01014975|P1|Participant Flow|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)
Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
608870|NCT01014975|O3|Outcome|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)
Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
608871|NCT01014975|O2|Outcome|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)
Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
608872|NCT01014975|O1|Outcome|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)
Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
608873|NCT01014975|E3|Reported Event|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)
Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
608874|NCT01014975|E2|Reported Event|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)
Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
608875|NCT01014975|E1|Reported Event|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)
Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
608876|NCT01014988|B7|Baseline|Total|Total of all reporting groups
608877|NCT01014988|B6|Baseline|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608878|NCT01014988|B5|Baseline|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608879|NCT01014988|B4|Baseline|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609090|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
611645|NCT01019928|O2|Outcome|Placebo|
608880|NCT01014988|B3|Baseline|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608881|NCT01014988|B2|Baseline|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608882|NCT01014988|B1|Baseline|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608883|NCT01014988|P6|Participant Flow|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608884|NCT01014988|P5|Participant Flow|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608885|NCT01014988|P4|Participant Flow|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608886|NCT01014988|P3|Participant Flow|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608887|NCT01014988|P2|Participant Flow|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608888|NCT01014988|P1|Participant Flow|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 milligrams (mg) zanamivir by intravenous (IV) infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608889|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608890|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608891|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608892|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608993|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
608893|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608894|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608895|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608896|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608897|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608898|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
610615|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
608899|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608900|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608901|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608902|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608903|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608904|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608905|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608906|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608907|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608908|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608909|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608910|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608911|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608912|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
622747|NCT01042145|O1|Outcome|Prednisone|
608913|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608914|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608915|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608916|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608917|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608918|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608919|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608920|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608921|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608922|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608923|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608924|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608925|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608926|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608927|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608928|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608929|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608930|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608931|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608932|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608933|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608934|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608935|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608936|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608937|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608938|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608939|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608940|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608941|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608942|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608943|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608944|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608945|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608946|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608947|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608948|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608949|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608950|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608951|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608952|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608953|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608954|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608955|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608956|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608957|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608958|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608959|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608960|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608961|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608962|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608963|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608964|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608965|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608966|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608967|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608968|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608969|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608970|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608971|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608972|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608973|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608974|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608975|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608976|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608977|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608978|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
610616|NCT01010971|O3|Outcome|Placebo|Placebo once daily
608979|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608980|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608981|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608982|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608983|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608984|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608985|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608986|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608987|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608988|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608989|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608990|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608991|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608992|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
609605|NCT01018095|O2|Outcome|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
608994|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608995|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608996|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608997|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
608998|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609091|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
610617|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
608999|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609000|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609001|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609002|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609003|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609004|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609005|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
609006|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
609007|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609008|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609009|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609010|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609011|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609012|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
609013|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
609080|NCT01015131|B1|Baseline|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
609427|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
609014|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609015|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609016|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609017|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609018|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609019|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
609020|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
609021|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609022|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609023|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609024|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609025|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609026|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
609027|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
609028|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609029|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609030|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609031|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609032|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609033|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
609034|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
609606|NCT01018095|O1|Outcome|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
609035|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609036|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609037|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609038|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609092|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
609039|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609040|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609041|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609042|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609043|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609044|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609045|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609046|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609047|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609048|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609049|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609050|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609051|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609081|NCT01015131|P1|Participant Flow|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
609052|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609053|NCT01014988|E6|Reported Event|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609054|NCT01014988|E5|Reported Event|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609055|NCT01014988|E4|Reported Event|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609093|NCT01015131|E1|Reported Event|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
609056|NCT01014988|E3|Reported Event|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609057|NCT01014988|E2|Reported Event|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609058|NCT01014988|E1|Reported Event|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
609059|NCT01015118|B3|Baseline|Total|Total of all reporting groups
609060|NCT01015118|B2|Baseline|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609061|NCT01015118|B1|Baseline|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609062|NCT01015118|P2|Participant Flow|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609063|NCT01015118|P1|Participant Flow|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609064|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609065|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609066|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609067|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609068|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609069|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609070|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609071|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609072|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609073|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609074|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609075|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609076|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609077|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609078|NCT01015118|E2|Reported Event|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609079|NCT01015118|E1|Reported Event|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
609082|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
609083|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
609084|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
609085|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
609086|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
609087|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
609088|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
609089|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
610618|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
609095|NCT01015170|P1|Participant Flow|Bupropion HCl|"Up to 8 week of bupropion SR (150mg BID) + counseling.
bupropion HCl: 150mg BID for up to 8 weeks + counseling"
609096|NCT01015170|O1|Outcome|Buproprion & Behavioural Support|8 weeks of buproprion-SR + brief counselling for smoking cessation
609097|NCT01015170|O1|Outcome|Bupropion HCl and Counselling|Bupropion HCl Up to 8 week of bupropion SR (150mg BID) + counseling.
609098|NCT01015170|O1|Outcome|Nicotine Replacement & Behavioural Support|"Nicotine Replacement Therapy: Transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
& Smoking cessation counselling-relapse prevention strategies."
609099|NCT01015170|E1|Reported Event|Bupropion HCl|"Up to 8 week of bupropion SR (150mg BID) + counseling.
bupropion HCl: 150mg BID for up to 8 weeks + counseling"
609100|NCT01015287|B3|Baseline|Total|Total of all reporting groups
609101|NCT01015287|B2|Baseline|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609102|NCT01015287|B1|Baseline|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609103|NCT01015287|P2|Participant Flow|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609104|NCT01015287|P1|Participant Flow|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609105|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609106|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609107|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609108|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609109|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609110|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609111|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609112|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609113|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609114|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609115|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609116|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609117|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609118|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609119|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609120|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609121|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609122|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609123|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
610619|NCT01010971|O3|Outcome|Placebo|Placebo once daily
609124|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609125|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609126|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609127|NCT01015287|E2|Reported Event|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609128|NCT01015287|E1|Reported Event|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
609129|NCT01015326|B3|Baseline|Total|Total of all reporting groups
609130|NCT01015326|B2|Baseline|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.
Questionnaire : Administered questionnaire"
609131|NCT01015326|B1|Baseline|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.
Questionnaire : Administered questionnaire"
609132|NCT01015326|P2|Participant Flow|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked through interview and questionnaire to rate items according to how important they are to the patient's health-related quality of life (HRQL).
Questionnaire : Administered questionnaire"
609133|NCT01015326|P1|Participant Flow|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.
Questionnaire : Administered questionnaire"
609134|NCT01015326|O2|Outcome|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.
Questionnaire : Administered questionnaire"
609135|NCT01015326|O1|Outcome|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.
Questionnaire : Administered questionnaire"
609202|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
622748|NCT01042145|O2|Outcome|Dexamethasone|
609136|NCT01015326|E2|Reported Event|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.
Questionnaire : Administered questionnaire"
609137|NCT01015326|E1|Reported Event|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.
Questionnaire : Administered questionnaire"
609138|NCT01015443|B3|Baseline|Total|Total of all reporting groups
609139|NCT01015443|B2|Baseline|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609214|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
611646|NCT01019928|O1|Outcome|AZD1386 95 mg|
609140|NCT01015443|B1|Baseline|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609141|NCT01015443|P2|Participant Flow|Saline + Placebo + BSC|A single IV infusion of 0.9 percent (%) sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609142|NCT01015443|P1|Participant Flow|Tecemotide (L-BLP25)+Cyclophosphamide+Best Supportive Care|A single intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 microgram (mcg) and then at 6-Week interval, beginning at Week 14 (maintenance phase) until disease progression (PD) is documented or the subject discontinued for any other reason. The best supportive care (BSC) was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609143|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609144|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609145|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609146|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609147|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
622749|NCT01042145|O1|Outcome|Prednisone|
609148|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609149|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609167|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
609168|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation,at a dose of 30 Gy in 10 daily fractions over 2 weeks
609215|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
609150|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609151|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609152|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609153|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609154|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609155|NCT01015443|E2|Reported Event|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609156|NCT01015443|E1|Reported Event|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
609157|NCT01015534|B3|Baseline|Total|Total of all reporting groups
609158|NCT01015534|B2|Baseline|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
609159|NCT01015534|B1|Baseline|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
609160|NCT01015534|P2|Participant Flow|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
609161|NCT01015534|P1|Participant Flow|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
609162|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
609428|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609163|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks,and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
609164|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
609165|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
609166|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
609212|NCT01015677|P2|Participant Flow|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
609213|NCT01015677|P1|Participant Flow|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609169|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Patients received Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
609170|NCT01015534|E2|Reported Event|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
609171|NCT01015534|E1|Reported Event|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
609172|NCT01015560|B1|Baseline|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
609173|NCT01015560|P1|Participant Flow|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
609174|NCT01015560|O1|Outcome|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
609175|NCT01015560|E1|Reported Event|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
609176|NCT01015638|B3|Baseline|Total|Total of all reporting groups
609177|NCT01015638|B2|Baseline|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609178|NCT01015638|B1|Baseline|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609179|NCT01015638|P2|Participant Flow|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609180|NCT01015638|P1|Participant Flow|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609181|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609182|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609183|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609184|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609185|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609186|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609187|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609188|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609189|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609190|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609191|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609192|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609193|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609194|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609195|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609196|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609197|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609198|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609199|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609200|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609201|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609203|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609204|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609205|NCT01015638|E2|Reported Event|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
609206|NCT01015638|E1|Reported Event|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
609207|NCT01015677|B4|Baseline|Total|Total of all reporting groups
609208|NCT01015677|B3|Baseline|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609209|NCT01015677|B2|Baseline|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
609210|NCT01015677|B1|Baseline|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609211|NCT01015677|P3|Participant Flow|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
611647|NCT01019928|O2|Outcome|Placebo|
609216|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609217|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609218|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
609219|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609220|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609221|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
609222|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609223|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609224|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
609225|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609226|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609227|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
609228|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609229|NCT01015677|E3|Reported Event|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609230|NCT01015677|E2|Reported Event|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
609231|NCT01015677|E1|Reported Event|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
609232|NCT01015703|B6|Baseline|Total|Total of all reporting groups
609233|NCT01015703|B5|Baseline|10 mg Dose|10 mg CoVaccine HT
609234|NCT01015703|B4|Baseline|7 mg Dose|7 mg CoVaccine HT
609235|NCT01015703|B3|Baseline|5 mg Dose|5 mg CoVaccine HT
609236|NCT01015703|B2|Baseline|2 mg Dose|2 mg CoVaccine HT
609237|NCT01015703|B1|Baseline|1 mg Dose|1 mg CoVaccine HT
609238|NCT01015703|P5|Participant Flow|10 mg Dose|10 mg CoVaccine HT
609239|NCT01015703|P4|Participant Flow|7 mg Dose|7 mg CoVaccine HT
609240|NCT01015703|P3|Participant Flow|5 mg Dose|5 mg CoVaccine HT
609241|NCT01015703|P2|Participant Flow|2 mg Dose|2 mg CoVaccine HT
609242|NCT01015703|P1|Participant Flow|1 mg Dose|1 mg CoVaccine HT
609243|NCT01015703|O5|Outcome|10 mg Dose|10 mg CoVaccine HT
609244|NCT01015703|O4|Outcome|7 mg Dose|7 mg CoVaccine HT
609245|NCT01015703|O3|Outcome|5 mg Dose|5 mg CoVaccine HT
609246|NCT01015703|O2|Outcome|2 mg Dose|2 mg CoVaccine HT
609247|NCT01015703|O1|Outcome|1 mg Dose|1 mg CoVaccine HT
609248|NCT01015703|E5|Reported Event|10 mg Dose|10 mg CoVaccine HT
609249|NCT01015703|E4|Reported Event|7 mg Dose|7 mg CoVaccine HT
609250|NCT01015703|E3|Reported Event|5 mg Dose|5 mg CoVaccine HT
609251|NCT01015703|E2|Reported Event|2 mg Dose|2 mg CoVaccine HT
609252|NCT01015703|E1|Reported Event|1 mg Dose|1 mg CoVaccine HT
609253|NCT01015781|B3|Baseline|Total|Total of all reporting groups
609254|NCT01015781|B2|Baseline|Wait List Control|VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
609255|NCT01015781|B1|Baseline|Immediate Care|"The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
609281|NCT01015820|O1|Outcome|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
609256|NCT01015781|P2|Participant Flow|Wait List Control|Wait List Control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
609257|NCT01015781|P1|Participant Flow|Immediate Care|"Immediate Care: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
609258|NCT01015781|O2|Outcome|Wait List Control|VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
609259|NCT01015781|O1|Outcome|Immediate Care|"The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
609523|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609260|NCT01015781|E2|Reported Event|Wait List Control|Wait List control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Usual care subjects also can be referred for other clinical services as deemed appropriate.
609261|NCT01015781|E1|Reported Event|Immediate Care|"Immediate Care: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
609262|NCT01015807|B4|Baseline|Total|Total of all reporting groups
609263|NCT01015807|B3|Baseline|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine
Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine
Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
609264|NCT01015807|B2|Baseline|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo
Clonidine Placebo: 2 x 1mL 0.9% NaCl
Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
609265|NCT01015807|B1|Baseline|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo
Bupivacaine Placebo: 2 x 20mL 0.9% NaCl
Clonidine Placebo: 2 x 1mL 0.9% NaCl"
609266|NCT01015807|P3|Participant Flow|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine
Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine
Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
609267|NCT01015807|P2|Participant Flow|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo
Clonidine Placebo: 2 x 1mL 0.9% NaCl
Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
609268|NCT01015807|P1|Participant Flow|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo
Bupivacaine Placebo: 2 x 20mL 0.9% NaCl
Clonidine Placebo: 2 x 1mL 0.9% NaCl"
609269|NCT01015807|O3|Outcome|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine
Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine
Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
609270|NCT01015807|O2|Outcome|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo
Clonidine Placebo: 2 x 1mL 0.9% NaCl
Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
609271|NCT01015807|O1|Outcome|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo
Bupivacaine Placebo: 2 x 20mL 0.9% NaCl
Clonidine Placebo: 2 x 1mL 0.9% NaCl"
609272|NCT01015807|E3|Reported Event|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine
Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine
Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
609273|NCT01015807|E2|Reported Event|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo
Clonidine Placebo: 2 x 1mL 0.9% NaCl
Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
609274|NCT01015807|E1|Reported Event|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo
Bupivacaine Placebo: 2 x 20mL 0.9% NaCl
Clonidine Placebo: 2 x 1mL 0.9% NaCl"
609275|NCT01015820|B3|Baseline|Total|Total of all reporting groups
609276|NCT01015820|B2|Baseline|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
609277|NCT01015820|B1|Baseline|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
609278|NCT01015820|P2|Participant Flow|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
609279|NCT01015820|P1|Participant Flow|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS). During the EUS, blood flow was measured in the duodenum with the Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF) device.
609280|NCT01015820|O2|Outcome|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
609424|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609282|NCT01015820|O2|Outcome|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
609283|NCT01015820|O1|Outcome|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
609284|NCT01015820|E2|Reported Event|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
609285|NCT01015820|E1|Reported Event|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
609286|NCT01015976|B1|Baseline|Active Drug|"Single arm study, all receive active drug
Sertraline : Single dose of 100mg sertraline"
609287|NCT01015976|P2|Participant Flow|Control Group|"active drug
No surgery matched subjects"
609288|NCT01015976|P1|Participant Flow|Experimental|Post surgery group Sertraline : Single dose of 100mg sertraline
609289|NCT01015976|O1|Outcome|Control|"Single arm study, all receive active drug
Sertraline : Single dose of 100mg sertraline"
609290|NCT01015976|E1|Reported Event|Active Drug|"Two arm study, all receive active drug
Sertraline : Single dose of 100mg sertraline"
611648|NCT01019928|O1|Outcome|AZD1386 95 mg|
609291|NCT01016015|B1|Baseline|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
609292|NCT01016015|P1|Participant Flow|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
609293|NCT01016015|O1|Outcome|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
609294|NCT01016015|E1|Reported Event|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
609295|NCT01016067|B3|Baseline|Total|Total of all reporting groups
609296|NCT01016067|B2|Baseline|Autograft Bone|Patients received autograft bone with rigid internal fixation.
609297|NCT01016067|B1|Baseline|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
609298|NCT01016067|P2|Participant Flow|Autograft Bone|Patients received autograft bone with rigid internal fixation.
609299|NCT01016067|P1|Participant Flow|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
609300|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
609301|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
609302|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
609303|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
609304|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
609305|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
609306|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
609307|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
609308|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
609309|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
609310|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
609311|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
609312|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
609313|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
609314|NCT01016067|E2|Reported Event|Autograft Bone|Patients received autograft bone with rigid internal fixation.
609315|NCT01016067|E1|Reported Event|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
609316|NCT01016106|B3|Baseline|Total|Total of all reporting groups
609317|NCT01016106|B2|Baseline|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
609318|NCT01016106|B1|Baseline|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
609319|NCT01016106|P2|Participant Flow|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.
609320|NCT01016106|P1|Participant Flow|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.
609321|NCT01016106|O2|Outcome|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
609322|NCT01016106|O1|Outcome|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
610588|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
609323|NCT01016106|E2|Reported Event|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
609324|NCT01016106|E1|Reported Event|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
609325|NCT01016132|B1|Baseline|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
609326|NCT01016132|P1|Participant Flow|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
609327|NCT01016132|O1|Outcome|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
609328|NCT01016132|E1|Reported Event|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
609329|NCT01017497|B1|Baseline|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
609330|NCT01017497|P1|Participant Flow|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
609331|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
609332|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
609333|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
609334|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
609335|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
609336|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
609337|NCT01017497|O2|Outcome|3mm Margin|"GTV expanded by 3 mm
Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
609338|NCT01017497|O1|Outcome|1mm Margin|"GTV expanded by 1 mm
Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
609339|NCT01017497|O2|Outcome|3mm Margin|"GTV expanded by 3 mm
Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
609340|NCT01017497|O1|Outcome|1mm Margin|"GTV expanded by 1 mm
Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
609341|NCT01017497|E1|Reported Event|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
609342|NCT01017536|B3|Baseline|Total|Total of all reporting groups
609343|NCT01017536|B2|Baseline|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
609344|NCT01017536|B1|Baseline|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
609345|NCT01017536|P2|Participant Flow|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
609346|NCT01017536|P1|Participant Flow|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
609347|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
609348|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
609349|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
609350|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
609351|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
609352|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
609353|NCT01017536|E2|Reported Event|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
609354|NCT01017536|E1|Reported Event|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
609355|NCT01017549|B1|Baseline|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
609356|NCT01017549|P1|Participant Flow|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
609357|NCT01017549|O1|Outcome|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
609358|NCT01017549|O1|Outcome|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
609359|NCT01017549|E1|Reported Event|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
609360|NCT01017575|B6|Baseline|Total|Total of all reporting groups
609361|NCT01017575|B5|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609524|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
611649|NCT01019928|O2|Outcome|Placebo|
609362|NCT01017575|B4|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609363|NCT01017575|B3|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609364|NCT01017575|B2|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609365|NCT01017575|B1|Baseline|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
609366|NCT01017575|P5|Participant Flow|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609367|NCT01017575|P4|Participant Flow|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609368|NCT01017575|P3|Participant Flow|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609369|NCT01017575|P2|Participant Flow|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609370|NCT01017575|P1|Participant Flow|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
609371|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609372|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609373|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609374|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609375|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
609425|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
609376|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609377|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609378|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609379|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609380|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
609381|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609382|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609383|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609384|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609385|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
609386|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609387|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609388|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609389|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609390|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
609391|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609392|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609393|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609426|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609394|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609395|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
609396|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609397|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609398|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609399|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
609400|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
609401|NCT01017575|E5|Reported Event|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609402|NCT01017575|E4|Reported Event|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
609403|NCT01017575|E3|Reported Event|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
609404|NCT01017575|E2|Reported Event|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
609405|NCT01017575|E1|Reported Event|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
609406|NCT01017601|B3|Baseline|Total|Total of all reporting groups
609407|NCT01017601|B2|Baseline|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
609408|NCT01017601|B1|Baseline|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609409|NCT01017601|P2|Participant Flow|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
609410|NCT01017601|P1|Participant Flow|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609411|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
609412|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609413|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
609414|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609415|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
609416|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609417|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
609418|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609419|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
609420|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609421|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
609422|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609423|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
610589|NCT01010971|O3|Outcome|Placebo|Placebo once daily
609429|NCT01017601|E2|Reported Event|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
609430|NCT01017601|E1|Reported Event|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
609431|NCT01017653|B1|Baseline|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
609432|NCT01017653|P1|Participant Flow|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
609525|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609526|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609433|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
609434|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
609435|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
609436|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
609437|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
609438|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
609439|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
609440|NCT01017653|E1|Reported Event|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
609441|NCT01017731|B1|Baseline|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609442|NCT01017731|P1|Participant Flow|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609463|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
609443|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609468|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
609444|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously over 1 hour, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: 25 to 50 milligrams (mg) administered intravenously 1 day before each administration of ramucirumab for Cycles 1 to 4. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609445|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609446|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609447|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609448|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609449|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609450|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609464|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
609465|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
609451|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609452|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609453|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609454|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609455|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609456|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609457|NCT01017731|E1|Reported Event|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.
Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.
Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
609458|NCT01017874|B3|Baseline|Total|Total of all reporting groups
609459|NCT01017874|B2|Baseline|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
609460|NCT01017874|B1|Baseline|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
609461|NCT01017874|P2|Participant Flow|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
609462|NCT01017874|P1|Participant Flow|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
609466|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
609467|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
609469|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
609527|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609470|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
609471|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
609472|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
609473|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
609474|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
609475|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
609476|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
609477|NCT01017874|E2|Reported Event|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
609478|NCT01017874|E1|Reported Event|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
609479|NCT01017952|B5|Baseline|Total|Total of all reporting groups
609480|NCT01017952|B4|Baseline|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609481|NCT01017952|B3|Baseline|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609482|NCT01017952|B2|Baseline|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609483|NCT01017952|B1|Baseline|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609484|NCT01017952|P5|Participant Flow|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609485|NCT01017952|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609486|NCT01017952|P3|Participant Flow|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609487|NCT01017952|P2|Participant Flow|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609511|NCT01018030|B2|Baseline|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609512|NCT01018030|B1|Baseline|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
622750|NCT01042145|O2|Outcome|Dexamethasone|
609488|NCT01017952|P1|Participant Flow|FP/SAL 250/50 µg BID|Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study.
609489|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609490|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609521|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609491|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609492|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609493|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609494|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609495|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609496|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609497|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609498|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609499|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609500|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609501|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609502|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609503|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609504|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609505|NCT01017952|E4|Reported Event|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609506|NCT01017952|E3|Reported Event|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609507|NCT01017952|E2|Reported Event|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609508|NCT01017952|E1|Reported Event|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
609509|NCT01018030|B4|Baseline|Total|Total of all reporting groups
609510|NCT01018030|B3|Baseline|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
622751|NCT01042145|O1|Outcome|Prednisone|
609514|NCT01018030|P2|Participant Flow|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609515|NCT01018030|P1|Participant Flow|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
609516|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609517|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609518|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609519|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609520|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609529|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609530|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609531|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609532|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609533|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609534|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609535|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609536|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609537|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609538|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609539|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609540|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609541|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609542|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609543|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609544|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609545|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609546|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609547|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609548|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609549|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609550|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609551|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609552|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609553|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609554|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
609555|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609556|NCT01018030|O2|Outcome|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609557|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
609558|NCT01018030|E3|Reported Event|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
609559|NCT01018030|E2|Reported Event|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
609560|NCT01018030|E1|Reported Event|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
609561|NCT01018056|B4|Baseline|Total|Total of all reporting groups
609562|NCT01018056|B3|Baseline|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
609607|NCT01018095|E2|Reported Event|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
609608|NCT01018095|E1|Reported Event|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
609609|NCT01018134|B7|Baseline|Total|Total of all reporting groups
609563|NCT01018056|B2|Baseline|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609564|NCT01018056|B1|Baseline|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609618|NCT01018134|P4|Participant Flow|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
609565|NCT01018056|P3|Participant Flow|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
609566|NCT01018056|P2|Participant Flow|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609567|NCT01018056|P1|Participant Flow|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609568|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for MASC is 4."
609569|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609570|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609571|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
Please note that two subjects failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for CDI-S is 3."
609572|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609573|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609574|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for DuPaul ADHD is 4."
609575|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609576|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609577|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
609578|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609579|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609580|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
610083|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
609581|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609582|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609583|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
609584|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609585|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609586|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
609587|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609588|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609589|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
609610|NCT01018134|B6|Baseline|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily
Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
622752|NCT01042145|O2|Outcome|Dexamethasone|
609590|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609591|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609592|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
609593|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609594|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609595|NCT01018056|E3|Reported Event|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
609596|NCT01018056|E2|Reported Event|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
609597|NCT01018056|E1|Reported Event|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
609598|NCT01018095|B3|Baseline|Total|Total of all reporting groups
609599|NCT01018095|B2|Baseline|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
609600|NCT01018095|B1|Baseline|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
609601|NCT01018095|P2|Participant Flow|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
609602|NCT01018095|P1|Participant Flow|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
609603|NCT01018095|O2|Outcome|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
609604|NCT01018095|O1|Outcome|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
609611|NCT01018134|B5|Baseline|Vehicle Once Daily|"Vehicle administered to affected areas once daily
Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
609612|NCT01018134|B4|Baseline|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
609613|NCT01018134|B3|Baseline|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
609614|NCT01018134|B2|Baseline|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area
Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
609615|NCT01018134|B1|Baseline|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area
Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
609616|NCT01018134|P6|Participant Flow|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily
Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
609617|NCT01018134|P5|Participant Flow|Vehicle Once Daily|"Vehicle administered to affected areas once daily
Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
609980|NCT01018680|B3|Baseline|Total|Total of all reporting groups
609619|NCT01018134|P3|Participant Flow|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
609620|NCT01018134|P2|Participant Flow|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area
Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
609621|NCT01018134|P1|Participant Flow|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area
Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
609622|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily
Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
609623|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily
Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
609624|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
609625|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
609626|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area
Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
609627|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area
Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
609628|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily
Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
609629|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily
Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
609630|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
609631|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
609632|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area
Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
609633|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area
Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
609634|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily
Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
609635|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily
Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
609636|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
609637|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
609638|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area
Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
609639|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area
Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
610084|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
609640|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily
Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
609641|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily
Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
609642|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
609643|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
609644|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area
Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
609645|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area
Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
609646|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily
Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
609647|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily
Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
610010|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
609648|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
609649|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
609650|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area
Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
609651|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area
Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
609652|NCT01018134|E6|Reported Event|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily
Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
609653|NCT01018134|E5|Reported Event|Vehicle Once Daily|"Vehicle administered to affected areas once daily
Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
609654|NCT01018134|E4|Reported Event|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
609655|NCT01018134|E3|Reported Event|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
609656|NCT01018134|E2|Reported Event|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area
Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
609657|NCT01018134|E1|Reported Event|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area
Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
609658|NCT01018186|B4|Baseline|Total|Total of all reporting groups
609659|NCT01018186|B3|Baseline|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609660|NCT01018186|B2|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609661|NCT01018186|B1|Baseline|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609662|NCT01018186|P4|Participant Flow|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609663|NCT01018186|P3|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609664|NCT01018186|P2|Participant Flow|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609665|NCT01018186|P1|Participant Flow|Current Asthma Therapy at a Fixed Dose|Participants were instructed to continue using an approved fixed dose of an inhaled corticosteroid (ICS) with or without an additional controller medication (i.e., long-acting beta-agonist, leukotriene modifier, etc.) for 2 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Run-in Period.
609666|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609667|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609668|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609669|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609670|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609671|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609672|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609673|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609674|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609675|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609676|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609677|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609678|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609679|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609680|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609681|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609682|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609683|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609684|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609685|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609686|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609687|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609688|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609689|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
610085|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
609690|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609691|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609692|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609693|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609694|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609695|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609696|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609697|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609698|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609699|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609700|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609701|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609702|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609703|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609704|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609705|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609706|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609707|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609708|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609709|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609710|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609711|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609712|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
610086|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
622753|NCT01042145|O1|Outcome|Prednisone|
609713|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609714|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609715|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609716|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609717|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albutero/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609718|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participnts were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609719|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609720|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609721|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609722|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609723|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609724|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609725|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609726|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609727|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609728|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609729|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609730|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609731|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609732|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609733|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609734|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609735|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
610087|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
609736|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609737|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609738|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609739|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609740|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609741|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609742|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609743|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609744|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609745|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609746|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609747|NCT01018186|E3|Reported Event|FP 500 µg BD|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609748|NCT01018186|E2|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609749|NCT01018186|E1|Reported Event|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
609750|NCT01018264|B3|Baseline|Total|Total of all reporting groups
609751|NCT01018264|B2|Baseline|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
609752|NCT01018264|B1|Baseline|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
609753|NCT01018264|P2|Participant Flow|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
609754|NCT01018264|P1|Participant Flow|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
609755|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
609756|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
609757|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
609758|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
609759|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
609760|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
609761|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
609762|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
609763|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
609764|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
609765|NCT01018264|E2|Reported Event|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
609766|NCT01018264|E1|Reported Event|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
609767|NCT01018394|B3|Baseline|Total|Total of all reporting groups
609768|NCT01018394|B2|Baseline|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.
tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
609769|NCT01018394|B1|Baseline|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.
nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
609770|NCT01018394|P2|Participant Flow|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.
tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
609771|NCT01018394|P1|Participant Flow|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.
nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
609772|NCT01018394|O2|Outcome|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.
tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
609773|NCT01018394|O1|Outcome|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.
nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
609774|NCT01018394|O2|Outcome|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.
tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
610097|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
609775|NCT01018394|O1|Outcome|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.
nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
609776|NCT01018394|E2|Reported Event|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.
tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
609777|NCT01018394|E1|Reported Event|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.
nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
609778|NCT01018420|B3|Baseline|Total|Total of all reporting groups
609779|NCT01018420|B2|Baseline|Moxifloxacin|400 mg capsule at the 6 hour point
609780|NCT01018420|B1|Baseline|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
609781|NCT01018420|P2|Participant Flow|Moxifloxacin|400 mg capsule at the 6 hour point
609782|NCT01018420|P1|Participant Flow|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
609783|NCT01018420|O9|Outcome|Hour 23|measured 23 hours after moxifloxacin dose
609784|NCT01018420|O8|Outcome|Hour 12|measured 12 hours after moxifloxacin dose
609785|NCT01018420|O7|Outcome|Hour 10|measured 10 hours after moxifloxacin dose
609786|NCT01018420|O6|Outcome|Hour 8|measured 8 hours after moxifloxacin dose
609787|NCT01018420|O5|Outcome|Hour 7|measured 7 hours after moxifloxacin dose
609788|NCT01018420|O4|Outcome|Hour 6|measured 6 hours after moxifloxacin dose
609789|NCT01018420|O3|Outcome|Hour 3|measured 3 hours after moxifloxacin dose
609790|NCT01018420|O2|Outcome|Hour 1|measured 1 hour after moxifloxacin dose
609791|NCT01018420|O1|Outcome|Baseline|measured 0.5 hour prior to moxifloxacin dose
609792|NCT01018420|O9|Outcome|Hour 23|measured 23 hours after initial colchicine dose
609793|NCT01018420|O8|Outcome|Hour 12|measured 12 hours after initial colchicine dose
609794|NCT01018420|O7|Outcome|Hour 10|measured 10 hours after initial colchicine dose
609795|NCT01018420|O6|Outcome|Hour 8|measured 8 hours after initial colchicine dose
609796|NCT01018420|O5|Outcome|Hour 7|measured 7 hours after initial colchicine dose
609797|NCT01018420|O4|Outcome|Hour 6|measured 6 hours after initial colchicine dose
609798|NCT01018420|O3|Outcome|Hour 3|measured 3 hours after initial colchicine dose
609799|NCT01018420|O2|Outcome|Hour 1|measured 1 hour after initial colchicine dose
609800|NCT01018420|O1|Outcome|Baseline|measured 0.5 hr prior to initial colchicine dose
609801|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
609802|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
609803|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
609804|NCT01018420|E2|Reported Event|Moxifloxacin|400 mg capsule at the 6 hour point
609805|NCT01018420|E1|Reported Event|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
609806|NCT01018511|B5|Baseline|Total|Total of all reporting groups
609807|NCT01018511|B4|Baseline|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609808|NCT01018511|B3|Baseline|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609809|NCT01018511|B2|Baseline|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609810|NCT01018511|B1|Baseline|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
610590|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
609811|NCT01018511|P4|Participant Flow|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609812|NCT01018511|P3|Participant Flow|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609813|NCT01018511|P2|Participant Flow|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609814|NCT01018511|P1|Participant Flow|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609815|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
610098|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
609816|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609817|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609818|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609819|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609820|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609821|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609822|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609823|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609824|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609825|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609826|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609827|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609828|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609829|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609830|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609831|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609832|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609833|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609834|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609835|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609836|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609837|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609838|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609839|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609840|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
610620|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
609841|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609842|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609843|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609844|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609845|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609846|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609847|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609848|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609849|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609850|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609851|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609852|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609853|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609854|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609855|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609856|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609857|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609858|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609859|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609860|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609861|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609862|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609863|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
610099|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
611650|NCT01019928|O1|Outcome|AZD1386 95 mg|
609864|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609865|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609866|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609867|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609868|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609869|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609870|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609871|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609872|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609873|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609874|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609875|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609876|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609877|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609878|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609879|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609880|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609881|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609882|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609906|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609883|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609884|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609885|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609886|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609887|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609888|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609889|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609890|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609891|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609892|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609893|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609894|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609895|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609896|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609897|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609898|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609899|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609900|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609901|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609902|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609903|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609904|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609905|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
610037|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
609907|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609908|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609909|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609910|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609911|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609912|NCT01018511|O4|Outcome|FDC 0.4 mg 9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609913|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609914|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609915|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609916|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609917|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609918|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609919|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609920|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609921|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609922|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609923|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609924|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609925|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609926|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609927|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609928|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609929|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
610038|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
609930|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609931|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609932|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609933|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
611651|NCT01019928|O2|Outcome|Placebo|
609934|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609935|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609936|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609937|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609938|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609939|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609940|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609941|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609942|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609943|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609944|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609945|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609946|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609947|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609948|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609949|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609950|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609951|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609952|NCT01018511|O4|Outcome|FDC 0.4 mg 9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
610039|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
609953|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609954|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609955|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609956|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609957|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609958|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609959|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609960|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609961|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609962|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609963|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609964|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609965|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609966|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609967|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609968|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609969|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609970|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609971|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609972|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609973|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609974|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609975|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
610080|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
622754|NCT01042145|O2|Outcome|Dexamethasone|
609976|NCT01018511|E4|Reported Event|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609977|NCT01018511|E3|Reported Event|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609978|NCT01018511|E2|Reported Event|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609979|NCT01018511|E1|Reported Event|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
609981|NCT01018680|B2|Baseline|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
609982|NCT01018680|B1|Baseline|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
609983|NCT01018680|P2|Participant Flow|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
609984|NCT01018680|P1|Participant Flow|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
609985|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
609986|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
609987|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
609988|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
609989|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
609990|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
609991|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
609992|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
609993|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
609994|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
609995|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
609996|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
609997|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
609998|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
609999|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610000|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
610001|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610002|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
610003|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610004|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
610081|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610005|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610006|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
610007|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610008|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
610009|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610011|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610012|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
610013|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610014|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
610015|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610016|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
610017|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610018|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
610019|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610020|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
610021|NCT01018680|E2|Reported Event|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
610022|NCT01018680|E1|Reported Event|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
610023|NCT01018732|B4|Baseline|Total|Total of all reporting groups
610024|NCT01018732|B3|Baseline|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
610025|NCT01018732|B2|Baseline|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
610026|NCT01018732|B1|Baseline|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
610027|NCT01018732|P3|Participant Flow|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
610028|NCT01018732|P2|Participant Flow|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
610029|NCT01018732|P1|Participant Flow|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
610030|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
610031|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610032|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610033|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
610034|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610035|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610036|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
610082|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610040|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610041|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610042|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
610043|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610044|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610045|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
610100|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
610046|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610047|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610048|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
610049|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610050|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610051|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
610052|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610053|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610054|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
610055|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610056|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
610057|NCT01018732|E3|Reported Event|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
610058|NCT01018732|E2|Reported Event|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
610059|NCT01018732|E1|Reported Event|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
610060|NCT01018810|B6|Baseline|Total|Total of all reporting groups
610061|NCT01018810|B5|Baseline|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610062|NCT01018810|B4|Baseline|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610063|NCT01018810|B3|Baseline|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610064|NCT01018810|B2|Baseline|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
610065|NCT01018810|B1|Baseline|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
610066|NCT01018810|P5|Participant Flow|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610067|NCT01018810|P4|Participant Flow|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610068|NCT01018810|P3|Participant Flow|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610069|NCT01018810|P2|Participant Flow|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
610070|NCT01018810|P1|Participant Flow|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
610071|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610072|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610073|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610074|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
610075|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
610076|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610077|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610078|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610079|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
610088|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610089|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
610090|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
610091|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610092|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610093|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610094|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
610095|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
610096|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610101|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610102|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610103|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610104|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
610105|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
610106|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610107|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610108|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610109|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
610110|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
610111|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610112|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610113|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610114|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
610115|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
610116|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610117|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610118|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
610119|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
610120|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
610121|NCT01018810|E5|Reported Event|90 mg LY2525623|
610122|NCT01018810|E4|Reported Event|30 mg LY2525623|
610123|NCT01018810|E3|Reported Event|3 mg LY2525623|
610124|NCT01018810|E2|Reported Event|Subcutaneous Placebo|
610125|NCT01018810|E1|Reported Event|180 mg LY2525623|
610126|NCT01018862|B4|Baseline|Total|Total of all reporting groups
610127|NCT01018862|B3|Baseline|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610128|NCT01018862|B2|Baseline|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610129|NCT01018862|B1|Baseline|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610130|NCT01018862|P3|Participant Flow|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610131|NCT01018862|P2|Participant Flow|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610132|NCT01018862|P1|Participant Flow|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610133|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610134|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610135|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610136|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610137|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610138|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610139|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610140|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
622755|NCT01042145|O1|Outcome|Prednisone|
610141|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610142|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610143|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610144|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610145|NCT01018862|E3|Reported Event|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610146|NCT01018862|E2|Reported Event|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610147|NCT01018862|E1|Reported Event|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
610148|NCT01018953|B1|Baseline|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).
BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
610149|NCT01018953|P1|Participant Flow|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).
BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
610150|NCT01018953|O1|Outcome|BIM 23A760|
610151|NCT01018953|O1|Outcome|BIM 23A760|
610152|NCT01018953|O1|Outcome|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).
BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
610153|NCT01018953|O1|Outcome|BIM 23A760|
610154|NCT01018953|O1|Outcome|BIM 23A760|
610155|NCT01018953|O1|Outcome|BIM 23A760|
610156|NCT01018953|O1|Outcome|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).
BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
610157|NCT01018953|E1|Reported Event|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).
BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
610158|NCT01018979|B3|Baseline|Total|Total of all reporting groups
610159|NCT01018979|B2|Baseline|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610160|NCT01018979|B1|Baseline|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610161|NCT01018979|P2|Participant Flow|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610162|NCT01018979|P1|Participant Flow|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610163|NCT01018979|O3|Outcome|All Patients|All patents = MM + NHL + HD
610164|NCT01018979|O2|Outcome|Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)|10 patients and 2 patients with NHL and HD were enrolled, respectively.
610165|NCT01018979|O1|Outcome|Multiple Myeloma (MM)|7 patients with MM were enrolled.
610256|NCT01019486|P1|Participant Flow|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
610166|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610167|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610168|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610169|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610170|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610171|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610172|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610173|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610174|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610175|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610176|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610177|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610178|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610179|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610180|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610181|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610182|NCT01018979|O3|Outcome|All Patients|All patents = MM + NHL + HD
610183|NCT01018979|O2|Outcome|Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)|10 patients and 2 patients with NHL and HD were enrolled, respectively.
610184|NCT01018979|O1|Outcome|Multiple Myeloma (MM)|7 patients with MM were enrolled.
610185|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610186|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610187|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610188|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610189|NCT01018979|E2|Reported Event|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610190|NCT01018979|E1|Reported Event|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
610191|NCT01018992|B3|Baseline|Total|Total of all reporting groups
610192|NCT01018992|B2|Baseline|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
610193|NCT01018992|B1|Baseline|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
610194|NCT01018992|P2|Participant Flow|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
610195|NCT01018992|P1|Participant Flow|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
610196|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
610197|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
610198|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
610199|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
610200|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
610201|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
610202|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
610203|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
610204|NCT01018992|E2|Reported Event|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
610205|NCT01018992|E1|Reported Event|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
610206|NCT01019135|B4|Baseline|Total|Total of all reporting groups
610207|NCT01019135|B3|Baseline|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610208|NCT01019135|B2|Baseline|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610209|NCT01019135|B1|Baseline|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610210|NCT01019135|P3|Participant Flow|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610211|NCT01019135|P2|Participant Flow|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610212|NCT01019135|P1|Participant Flow|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610213|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610214|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610215|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610216|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610217|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610218|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610219|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610220|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610221|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610222|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610223|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610224|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610267|NCT01019694|B4|Baseline|Total|Total of all reporting groups
610225|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610226|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610227|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610228|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610229|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610230|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610231|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610232|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610233|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610234|NCT01019135|E3|Reported Event|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610235|NCT01019135|E2|Reported Event|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610236|NCT01019135|E1|Reported Event|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
610237|NCT01019317|B1|Baseline|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
610238|NCT01019317|P1|Participant Flow|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
610239|NCT01019317|O1|Outcome|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
610240|NCT01019317|E1|Reported Event|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
610241|NCT01019369|B3|Baseline|Total|Total of all reporting groups
610242|NCT01019369|B2|Baseline|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
610243|NCT01019369|B1|Baseline|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
610244|NCT01019369|P2|Participant Flow|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
610245|NCT01019369|P1|Participant Flow|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
610246|NCT01019369|O2|Outcome|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
610247|NCT01019369|O1|Outcome|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
610248|NCT01019369|E2|Reported Event|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
610249|NCT01019369|E1|Reported Event|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
610250|NCT01019486|B4|Baseline|Total|Total of all reporting groups
610251|NCT01019486|B3|Baseline|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
610252|NCT01019486|B2|Baseline|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
610253|NCT01019486|B1|Baseline|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
610254|NCT01019486|P3|Participant Flow|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
610255|NCT01019486|P2|Participant Flow|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
610446|NCT01007812|O1|Outcome|Lotrafilcon B Contact Lens|Silicone hydrogel, toric, soft contact lens
610257|NCT01019486|O3|Outcome|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
610258|NCT01019486|O2|Outcome|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
610259|NCT01019486|O1|Outcome|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
610260|NCT01019486|O1|Outcome|Abnormal MPI Study|These subjects demonstrated abnormal radionuclide myocardial perfusion imaging studies with perfusion defects in response to regadenoson stress. The perfusion defect qualified the subject to participated in invasive CFR measurements. Coronary arteries within the region of the perfusion defect were cannulated for CFR measurements. Flow measurements were performed in the 2 normal vessels and the abnormal vessel both at rest and following regadenoson administration to calculated CFR values..
610261|NCT01019486|O3|Outcome|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
610262|NCT01019486|O2|Outcome|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
610263|NCT01019486|O1|Outcome|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
610264|NCT01019486|E3|Reported Event|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
610265|NCT01019486|E2|Reported Event|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
610266|NCT01019486|E1|Reported Event|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
610268|NCT01019694|B3|Baseline|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610269|NCT01019694|B2|Baseline|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610270|NCT01019694|B1|Baseline|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610271|NCT01019694|P3|Participant Flow|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610272|NCT01019694|P2|Participant Flow|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610273|NCT01019694|P1|Participant Flow|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610274|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610275|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610276|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610277|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610278|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610279|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610280|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610281|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610282|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610283|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610284|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610285|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610286|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610287|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610288|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610289|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610290|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610291|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610292|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610293|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610294|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610295|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610296|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610297|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610298|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610299|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610300|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610301|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610302|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610303|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610304|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610305|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610306|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610307|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610308|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610447|NCT01007812|E2|Reported Event|Comfilcon A Contact Lens|Silicone hydrogel, toric, soft contact lens
610309|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610310|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610311|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610312|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610313|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610314|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610315|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610316|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610317|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610318|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610319|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610320|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610321|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610322|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610323|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610324|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610325|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610326|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610327|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610328|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610329|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610330|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610331|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610332|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610333|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610334|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610335|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610336|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610337|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610338|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610339|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610340|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610341|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610342|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610343|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610344|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610345|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610346|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610347|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610348|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610349|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610350|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610351|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610352|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610353|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610354|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610355|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610356|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610357|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610358|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610359|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610360|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610361|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610362|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610363|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610364|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610365|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610366|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610367|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610368|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610369|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610370|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610371|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610372|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610373|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610374|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610375|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610376|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610377|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610378|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610379|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610380|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610381|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610382|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610383|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610384|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610385|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610386|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610387|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610388|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610389|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610390|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610391|NCT01019694|E3|Reported Event|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
610392|NCT01019694|E2|Reported Event|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
610393|NCT01019694|E1|Reported Event|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
610394|NCT01019707|B1|Baseline|Total Sample|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine and placebo. The order of study drug was determined randomly.
610395|NCT01019707|P2|Participant Flow|Placebo, Then Atomoxetine|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under placebo for 15 days and then atomoxetine for 9 days after a 14 day wash out. The order of study drug was determined randomly.
610396|NCT01019707|P1|Participant Flow|Atomoxetine, Then Placebo|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine for 15 days and then placebo for 9 days after a 14 day wash out. The order of study drug was determined randomly.
610397|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
610398|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
610399|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
610400|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
610401|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
610402|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
610403|NCT01019707|E2|Reported Event|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
610448|NCT01007812|E1|Reported Event|Lotrafilcon B Contact Lens|Silicone hydrogel, toric, soft contact lens
610449|NCT01007838|B5|Baseline|Total|Total of all reporting groups
622756|NCT01042145|E2|Reported Event|Dexamethasone|
610404|NCT01019707|E1|Reported Event|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
610405|NCT01007552|B1|Baseline|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
610406|NCT01007552|P1|Participant Flow|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
610407|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
610408|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
610409|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
610410|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
610411|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
610412|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
610413|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
610414|NCT01007552|E1|Reported Event|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
610415|NCT01007643|B3|Baseline|Total|Total of all reporting groups
610416|NCT01007643|B2|Baseline|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
610417|NCT01007643|B1|Baseline|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
610418|NCT01007643|P2|Participant Flow|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
610419|NCT01007643|P1|Participant Flow|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
610420|NCT01007643|O2|Outcome|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
610421|NCT01007643|O1|Outcome|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
610422|NCT01007643|E2|Reported Event|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
610423|NCT01007643|E1|Reported Event|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
610424|NCT01007656|B1|Baseline|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610425|NCT01007656|P1|Participant Flow|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610426|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610427|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610428|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610429|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610531|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
611652|NCT01019928|O1|Outcome|AZD1386 95 mg|
610430|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610431|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610432|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610433|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610434|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610435|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610436|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610437|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610438|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610439|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610440|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610441|NCT01007656|E1|Reported Event|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
610442|NCT01007812|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects.
610443|NCT01007812|P2|Participant Flow|Comfilcon A / Lotrafilcon B|Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
610444|NCT01007812|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
610445|NCT01007812|O2|Outcome|Comfilcon A Contact Lens|Silicone hydrogel, toric, soft contact lens
610450|NCT01007838|B4|Baseline|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
610451|NCT01007838|B3|Baseline|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
610452|NCT01007838|B2|Baseline|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
610453|NCT01007838|B1|Baseline|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
610454|NCT01007838|P4|Participant Flow|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
610455|NCT01007838|P3|Participant Flow|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
610456|NCT01007838|P2|Participant Flow|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
611653|NCT01019928|O2|Outcome|Placebo|
610457|NCT01007838|P1|Participant Flow|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
610458|NCT01007838|O4|Outcome|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
610459|NCT01007838|O3|Outcome|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
610460|NCT01007838|O2|Outcome|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
610461|NCT01007838|O1|Outcome|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
610462|NCT01007838|E4|Reported Event|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
610463|NCT01007838|E3|Reported Event|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
610464|NCT01007838|E2|Reported Event|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
610465|NCT01007838|E1|Reported Event|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
610466|NCT01007916|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects
610467|NCT01007916|P2|Participant Flow|Habitual / Lotrafilcon B|Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
610468|NCT01007916|P1|Participant Flow|Lotrafilcon B / Habitual|Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
610469|NCT01007916|O2|Outcome|Habitual|Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
610470|NCT01007916|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.
610471|NCT01007916|E2|Reported Event|Habitual|Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
610472|NCT01007916|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.
610473|NCT01007942|B3|Baseline|Total|Total of all reporting groups
610474|NCT01007942|B2|Baseline|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610475|NCT01007942|B1|Baseline|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610476|NCT01007942|P2|Participant Flow|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610477|NCT01007942|P1|Participant Flow|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610478|NCT01007942|O2|Outcome|Everolimus Placebo|Oral placebo everolimus of 5 mg/day
610479|NCT01007942|O1|Outcome|Everolimus|Oral everolimus of 5 mg/day
610480|NCT01007942|O2|Outcome|Everolimus Placebo|Oral placebo everolimus of 5 mg/day
610481|NCT01007942|O1|Outcome|Everolimus|Oral everolimus of 5 mg/day
610482|NCT01007942|O2|Outcome|Everolimus|Oral everolimus of 5 mg/day
610483|NCT01007942|O1|Outcome|Everolimus 2.5 mg|Oral everolimus of 2.5 mg/day
610484|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
622757|NCT01042145|E1|Reported Event|Prednisone|
610485|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610486|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610487|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610488|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610489|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610490|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610532|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
610491|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610492|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610493|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610494|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610495|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610496|NCT01007942|E2|Reported Event|Placebo + Trastuzumab + Vinorelbine|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610497|NCT01007942|E1|Reported Event|Everolimus + Trastuzumab + Vinorelbine|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
610498|NCT01010906|B7|Baseline|Total|Total of all reporting groups
610499|NCT01010906|B6|Baseline|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
610500|NCT01010906|B5|Baseline|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
610501|NCT01010906|B4|Baseline|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
610502|NCT01010906|B3|Baseline|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
610503|NCT01010906|B2|Baseline|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
610504|NCT01010906|B1|Baseline|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
610505|NCT01010906|P6|Participant Flow|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
610506|NCT01010906|P5|Participant Flow|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
610507|NCT01010906|P4|Participant Flow|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
610508|NCT01010906|P3|Participant Flow|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
610509|NCT01010906|P2|Participant Flow|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
610510|NCT01010906|P1|Participant Flow|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
610511|NCT01010906|O6|Outcome|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
610512|NCT01010906|O5|Outcome|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
610513|NCT01010906|O4|Outcome|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
610514|NCT01010906|O3|Outcome|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
610515|NCT01010906|O2|Outcome|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
610516|NCT01010906|O1|Outcome|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
610517|NCT01010906|O6|Outcome|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
610518|NCT01010906|O5|Outcome|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
610519|NCT01010906|O4|Outcome|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
610520|NCT01010906|O3|Outcome|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
610521|NCT01010906|O2|Outcome|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
610522|NCT01010906|O1|Outcome|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
610523|NCT01010906|E6|Reported Event|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
622896|NCT01042613|B3|Baseline|Total|Total of all reporting groups
610524|NCT01010906|E5|Reported Event|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
610525|NCT01010906|E4|Reported Event|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
610526|NCT01010906|E3|Reported Event|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
610527|NCT01010906|E2|Reported Event|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
610528|NCT01010906|E1|Reported Event|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
610529|NCT01010932|B1|Baseline|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.
Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
610530|NCT01010932|P1|Participant Flow|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.
Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
610533|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
610534|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
610535|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
610536|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
610537|NCT01010932|E4|Reported Event|Patients Discontinued Without Dotarem Administration|Patients withdrawn before administration of Dotarem whatever the reason
610538|NCT01010932|E3|Reported Event|Computerized Tomography Angiography (CTA)|Patients benefiting from a CT angiography with an IV injection of iodinated contrast medium
610539|NCT01010932|E2|Reported Event|TOF MRA|Patients benefiting from a MR angiography with no contrast medium administration
610540|NCT01010932|E1|Reported Event|Dotarem MRA|Patients benefiting from a MR angiography after an IV administration of Dotarem
610541|NCT01010971|B4|Baseline|Total|Total of all reporting groups
610542|NCT01010971|B3|Baseline|Placebo|Placebo once daily
610543|NCT01010971|B2|Baseline|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610544|NCT01010971|B1|Baseline|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610545|NCT01010971|P3|Participant Flow|Placebo|Placebo once daily
610546|NCT01010971|P2|Participant Flow|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610547|NCT01010971|P1|Participant Flow|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610548|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610549|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610550|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610551|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610552|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610553|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610554|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610555|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610556|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610557|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610558|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610559|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610560|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610561|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610562|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610563|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610564|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610565|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610566|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610567|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610568|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610569|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610570|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610571|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610572|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610573|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610574|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610575|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610576|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610577|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610578|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610579|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610580|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610581|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610582|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610583|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610584|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610585|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610586|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610587|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610591|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610592|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610593|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610594|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610595|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610596|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610597|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610598|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610599|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610600|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610601|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610602|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610603|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610604|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610605|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610606|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610607|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610608|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610621|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610622|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610623|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610624|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610625|NCT01010971|O3|Outcome|Placebo|Placebo once daily
610626|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610627|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610628|NCT01010971|E3|Reported Event|Placebo|Placebo once daily
610629|NCT01010971|E2|Reported Event|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
610630|NCT01010971|E1|Reported Event|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
610631|NCT01011049|B5|Baseline|Total|Total of all reporting groups
610632|NCT01011049|B4|Baseline|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
610633|NCT01011049|B3|Baseline|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
610634|NCT01011049|B2|Baseline|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
610635|NCT01011049|B1|Baseline|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
610636|NCT01011049|P4|Participant Flow|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
610637|NCT01011049|P3|Participant Flow|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
610638|NCT01011049|P2|Participant Flow|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
610639|NCT01011049|P1|Participant Flow|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
610640|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
610641|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
610642|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
610643|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
610644|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
610645|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
610646|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
610647|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
623063|NCT01052480|B3|Baseline|Total|Total of all reporting groups
610648|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
610649|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
610650|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
610651|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
610652|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
610653|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
610654|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
610655|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
610656|NCT01011049|E4|Reported Event|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
610657|NCT01011049|E3|Reported Event|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
610658|NCT01011049|E2|Reported Event|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
610659|NCT01011049|E1|Reported Event|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
610660|NCT01011075|B1|Baseline|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
610661|NCT01011075|P1|Participant Flow|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
610662|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
610663|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
610664|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
610665|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
610666|NCT01011075|E1|Reported Event|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
610667|NCT01011153|B4|Baseline|Total|Total of all reporting groups
610668|NCT01011153|B3|Baseline|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
610669|NCT01011153|B2|Baseline|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
610670|NCT01011153|B1|Baseline|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
610671|NCT01011153|P3|Participant Flow|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
610672|NCT01011153|P2|Participant Flow|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
610673|NCT01011153|P1|Participant Flow|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
610674|NCT01011153|O3|Outcome|Primary Care Physicians|
610675|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|
610676|NCT01011153|O1|Outcome|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
610677|NCT01011153|O4|Outcome|All Partipants|All Participants are the General Dermatologists, Pigmented Skin Lesion Experts and Primary Care Physicians combined.
610678|NCT01011153|O3|Outcome|Primary Care Physicians|Physicians who are not Board Certified Dermatologists and Pediatricians. Each PCP was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
610764|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
610679|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|Physicians who spend at least 25% of their practice time examining pigmented skin lesions. Each PSL Expert was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
610680|NCT01011153|O1|Outcome|Dermatologists|General Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
610681|NCT01011153|O4|Outcome|MelaFind|MelaFind imaged the 130 cases, the 65 positive cases (i.e., histologically confirmed melanoma) and the 65 negative cases (i.e., histologically confirmed non-melanoma). Sensitivity was calculated based on the correct identification of the 65 positive cases and specificity was calculated based on the correct identification of the 65 negative cases.
610682|NCT01011153|O3|Outcome|Primary Care Physicians|Physicians who are not Board Certified Dermatologists and Pediatricians. Each PCP was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
610683|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|Physicians who spend at least 25% of their practice time examining pigmented skin lesions. Each PSL Expert was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
610684|NCT01011153|O1|Outcome|General Dermatologists|General Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
610685|NCT01011153|O2|Outcome|MelaFind|MelaFind imaged 130 cases which consisted of 65 positive cases (i.e., histolgoically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
610719|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
610720|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
610686|NCT01011153|O1|Outcome|Dermatologists|Dermatologists were defined as board-certified dermatologists who were General Dermatologists and Pigmented Skin Lesion Experts, according to the Intake Survey. Dermatologists in this group did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consistinf of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
610687|NCT01011153|E3|Reported Event|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
610688|NCT01011153|E2|Reported Event|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
610689|NCT01011153|E1|Reported Event|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
610690|NCT01011179|B3|Baseline|Total|Total of all reporting groups
610691|NCT01011179|B2|Baseline|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
610692|NCT01011179|B1|Baseline|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
610693|NCT01011179|P2|Participant Flow|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
610694|NCT01011179|P1|Participant Flow|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
610695|NCT01011179|O2|Outcome|Attention Control Group|"Self-Management: Adolescents' own best efforts at managing their JIA"
610696|NCT01011179|O1|Outcome|Internet-based JIA Self-Management Program|Teens Taking Charge: The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
610697|NCT01011179|E2|Reported Event|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
610698|NCT01011179|E1|Reported Event|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
610699|NCT01011283|B3|Baseline|Total|Total of all reporting groups
610700|NCT01011283|B2|Baseline|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
610701|NCT01011283|B1|Baseline|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
623317|NCT01053897|O1|Outcome|GBT009|Therapy treated scar segment
610702|NCT01011283|P2|Participant Flow|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
610703|NCT01011283|P1|Participant Flow|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
610704|NCT01011283|O2|Outcome|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
610705|NCT01011283|O1|Outcome|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
610706|NCT01011283|O2|Outcome|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
610707|NCT01011283|O1|Outcome|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
610708|NCT01011283|E2|Reported Event|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
610709|NCT01011283|E1|Reported Event|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
610710|NCT01011309|B4|Baseline|Total|Total of all reporting groups
610711|NCT01011309|B3|Baseline|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
610712|NCT01011309|B2|Baseline|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
610713|NCT01011309|B1|Baseline|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
610714|NCT01011309|P3|Participant Flow|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
610715|NCT01011309|P2|Participant Flow|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
610716|NCT01011309|P1|Participant Flow|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
610717|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
610718|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
610721|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
610722|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
610723|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
610724|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
610725|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
610726|NCT01011309|E3|Reported Event|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
610727|NCT01011309|E2|Reported Event|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
610728|NCT01011309|E1|Reported Event|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
610729|NCT01011387|B1|Baseline|NPWT System|Negative Pressure Wound Therapy
610730|NCT01011387|P1|Participant Flow|Negative Pressure Wound Therapy System|The Avance NPWT system is intended to help promote wound healing, including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressure. Avance NPWT system is designed to be used for a wide range of wounds which are suitable for NPWT.
610731|NCT01011387|O1|Outcome|NPWT System|Negative Pressure Wound Therapy
610732|NCT01011387|E1|Reported Event|NPWT System|Negative Pressure Wound Therapy
610733|NCT01011465|B9|Baseline|Total|Total of all reporting groups
610734|NCT01011465|B8|Baseline|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610735|NCT01011465|B7|Baseline|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
610736|NCT01011465|B6|Baseline|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610737|NCT01011465|B5|Baseline|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
610738|NCT01011465|B4|Baseline|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610739|NCT01011465|B3|Baseline|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
610769|NCT01011465|E7|Reported Event|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
611654|NCT01019928|O1|Outcome|AZD1386 95 mg|
610740|NCT01011465|B2|Baseline|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610741|NCT01011465|B1|Baseline|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
610742|NCT01011465|P8|Participant Flow|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610743|NCT01011465|P7|Participant Flow|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
610744|NCT01011465|P6|Participant Flow|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610745|NCT01011465|P5|Participant Flow|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
610765|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
610766|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
625546|NCT01058421|B3|Baseline|Total|Total of all reporting groups
610746|NCT01011465|P4|Participant Flow|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610747|NCT01011465|P3|Participant Flow|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
610791|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610792|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610793|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
611655|NCT01019928|O2|Outcome|Placebo|
610748|NCT01011465|P2|Participant Flow|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610749|NCT01011465|P1|Participant Flow|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
610750|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
610751|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
610752|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
610753|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
610754|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
610755|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
610756|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
610757|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
610758|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
610759|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
610760|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
610761|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
610762|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
610763|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
610767|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
610768|NCT01011465|E8|Reported Event|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610794|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
611656|NCT01019928|O1|Outcome|AZD1386 95 mg|
610770|NCT01011465|E6|Reported Event|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610771|NCT01011465|E5|Reported Event|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
610772|NCT01011465|E4|Reported Event|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610773|NCT01011465|E3|Reported Event|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.
Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
610774|NCT01011465|E2|Reported Event|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
610775|NCT01011465|E1|Reported Event|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.
Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
610776|NCT01011556|B5|Baseline|Total|Total of all reporting groups
610777|NCT01011556|B4|Baseline|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610778|NCT01011556|B3|Baseline|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610779|NCT01011556|B2|Baseline|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610780|NCT01011556|B1|Baseline|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610781|NCT01011556|P4|Participant Flow|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610782|NCT01011556|P3|Participant Flow|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610783|NCT01011556|P2|Participant Flow|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610784|NCT01011556|P1|Participant Flow|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610785|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610786|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610787|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610788|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610789|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610790|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
611657|NCT01019928|O2|Outcome|Placebo|
610795|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610796|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610797|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610798|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610799|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610800|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610801|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610802|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610803|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610804|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610805|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610806|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610807|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610808|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 mcg teriparatide subcutaneously once daily in an unblinded manner.
610809|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610810|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610811|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610812|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610813|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610814|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610815|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610816|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610817|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610818|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610819|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610820|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610821|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610822|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610823|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610824|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610825|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610826|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610827|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610828|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
610829|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610830|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610831|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level
610832|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
610833|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610834|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610945|NCT01011868|B1|Baseline|Placebo|Oral Placebo
610835|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610836|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
610837|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610838|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610839|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610840|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610841|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610842|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610843|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610844|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610845|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610846|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610847|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610848|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
610849|NCT01011556|E4|Reported Event|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610850|NCT01011556|E3|Reported Event|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610851|NCT01011556|E2|Reported Event|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
610852|NCT01011556|E1|Reported Event|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
610853|NCT01011634|B3|Baseline|Total|Total of all reporting groups
610854|NCT01011634|B2|Baseline|Oral Medication|
610855|NCT01011634|B1|Baseline|Moderate Sedation|
610856|NCT01011634|P2|Participant Flow|Oral Medication|
610857|NCT01011634|P1|Participant Flow|Moderate Sedation|
610858|NCT01011634|O2|Outcome|Oral Medication|
610859|NCT01011634|O1|Outcome|Moderate Sedation|
610860|NCT01011634|O2|Outcome|Oral Medication|
610861|NCT01011634|O1|Outcome|Moderate Sedation|
610862|NCT01011634|E2|Reported Event|IV Medications|
610863|NCT01011634|E1|Reported Event|Oral Medications|
610864|NCT01011673|B3|Baseline|Total|Total of all reporting groups
610865|NCT01011673|B2|Baseline|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
610866|NCT01011673|B1|Baseline|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
610867|NCT01011673|P2|Participant Flow|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
610868|NCT01011673|P1|Participant Flow|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
611023|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
610869|NCT01011673|O2|Outcome|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
610870|NCT01011673|O1|Outcome|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
610871|NCT01011673|O2|Outcome|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
610872|NCT01011673|O1|Outcome|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
610873|NCT01011673|E2|Reported Event|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
610874|NCT01011673|E1|Reported Event|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
610875|NCT01011738|B4|Baseline|Total|Total of all reporting groups
610876|NCT01011738|B3|Baseline|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
610877|NCT01011738|B2|Baseline|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610878|NCT01011738|B1|Baseline|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610879|NCT01011738|P3|Participant Flow|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
610946|NCT01011868|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610947|NCT01011868|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610948|NCT01011868|P1|Participant Flow|Placebo|Oral Placebo
610880|NCT01011738|P2|Participant Flow|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610881|NCT01011738|P1|Participant Flow|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610882|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
610883|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610884|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610885|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
610886|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610887|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610888|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
610889|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610890|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610891|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
610928|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|"One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc
BIOSTAT BIOLOGX: One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device"
610929|NCT01011816|E2|Reported Event|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
610892|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610893|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610894|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610895|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610949|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610950|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610951|NCT01011868|O1|Outcome|Placebo|Oral Placebo
610896|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610897|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610898|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610899|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610900|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610901|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610902|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610903|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610904|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610905|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610930|NCT01011816|E1|Reported Event|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
610931|NCT01011829|B3|Baseline|Total|Total of all reporting groups
610932|NCT01011829|B2|Baseline|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
625580|NCT01047293|B1|Baseline|All Patients|
610906|NCT01011738|O1|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610907|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610908|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610909|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610952|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
611658|NCT01019928|O1|Outcome|AZD1386 95 mg|
610910|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610911|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610912|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610913|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610914|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610915|NCT01011738|E3|Reported Event|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
610916|NCT01011738|E2|Reported Event|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
610917|NCT01011738|E1|Reported Event|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
610918|NCT01011816|B3|Baseline|Total|Total of all reporting groups
610919|NCT01011816|B2|Baseline|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
610920|NCT01011816|B1|Baseline|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
610921|NCT01011816|P2|Participant Flow|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
610922|NCT01011816|P1|Participant Flow|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
610923|NCT01011816|O2|Outcome|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
610924|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
610925|NCT01011816|O2|Outcome|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
610926|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
610927|NCT01011816|O2|Outcome|Saline|"One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc
Saline: One injection of up to 4 mL of saline using the Biostat Delivery Device"
610933|NCT01011829|B1|Baseline|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
610934|NCT01011829|P2|Participant Flow|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
610935|NCT01011829|P1|Participant Flow|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
610936|NCT01011829|O2|Outcome|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
610937|NCT01011829|O1|Outcome|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
610938|NCT01011829|O2|Outcome|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
610939|NCT01011829|O1|Outcome|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
610940|NCT01011829|E2|Reported Event|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
610941|NCT01011829|E1|Reported Event|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
610942|NCT01011868|B4|Baseline|Total|Total of all reporting groups
610943|NCT01011868|B3|Baseline|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610944|NCT01011868|B2|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610953|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610954|NCT01011868|O1|Outcome|Placebo|Oral Placebo
610955|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610956|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610957|NCT01011868|O1|Outcome|Placebo|Oral Placebo
610958|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610959|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610960|NCT01011868|O1|Outcome|Placebo|Oral Placebo
610961|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610962|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610963|NCT01011868|O1|Outcome|Placebo|Oral Placebo
610964|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610965|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610966|NCT01011868|O1|Outcome|Placebo|Oral Placebo
610967|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610968|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610969|NCT01011868|O1|Outcome|Placebo|Oral Placebo
610970|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610971|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610972|NCT01011868|O1|Outcome|Placebo|Oral Placebo
610973|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610974|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610975|NCT01011868|O1|Outcome|Placebo|Oral Placebo
610976|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610977|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610978|NCT01011868|O1|Outcome|Placebo|Oral Placebo
610979|NCT01011868|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
610980|NCT01011868|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
610981|NCT01011868|E1|Reported Event|Placebo|Oral Placebo
610982|NCT01011894|B1|Baseline|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
610983|NCT01011894|P1|Participant Flow|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
610984|NCT01011894|O1|Outcome|Participants Receiving Lenalidomide|Patients with intermediate or high-risk chronic lymphocytic leukemia (≥ 65 years old) will receive lenalidomide until disease progression at the 20mg dose level (recognizing that progression at this dose requires non-protocol alternate therapy) or unacceptable toxicity.
610985|NCT01011894|E1|Reported Event|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
610986|NCT01011907|B3|Baseline|Total|Total of all reporting groups
610987|NCT01011907|B2|Baseline|Varenicline|
610988|NCT01011907|B1|Baseline|Placebo|
610989|NCT01011907|P2|Participant Flow|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
610990|NCT01011907|P1|Participant Flow|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
611021|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611022|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
610991|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
610992|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
610993|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
610994|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
610995|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
610996|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
610997|NCT01011907|E2|Reported Event|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
610998|NCT01011907|E1|Reported Event|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
610999|NCT01011933|B1|Baseline|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
611000|NCT01011933|P1|Participant Flow|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
611001|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
611002|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
611003|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
611004|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
611005|NCT01011933|E1|Reported Event|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
611006|NCT01011946|B1|Baseline|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
611007|NCT01011946|P1|Participant Flow|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
611008|NCT01011946|O1|Outcome|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
611009|NCT01011946|E1|Reported Event|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
611010|NCT01012037|B4|Baseline|Total|Total of all reporting groups
611011|NCT01012037|B3|Baseline|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611012|NCT01012037|B2|Baseline|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611013|NCT01012037|B1|Baseline|Placebo|Patients treated with matching placebo
611014|NCT01012037|P3|Participant Flow|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611015|NCT01012037|P2|Participant Flow|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611016|NCT01012037|P1|Participant Flow|Placebo|Patients treated with matching placebo
611017|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611018|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611019|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
611020|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611024|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611025|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
611026|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611027|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611028|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
611029|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611030|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611031|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
611032|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611033|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611034|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
611035|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611036|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611037|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
611038|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611039|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611040|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
611041|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611042|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611043|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
611044|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611045|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611046|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
611047|NCT01012037|E3|Reported Event|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
611048|NCT01012037|E2|Reported Event|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
611049|NCT01012037|E1|Reported Event|Placebo|Patients treated with matching placebo
611050|NCT01012167|B4|Baseline|Total|Total of all reporting groups
611051|NCT01012167|B3|Baseline|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
611052|NCT01012167|B2|Baseline|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
611053|NCT01012167|B1|Baseline|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
611054|NCT01012167|P3|Participant Flow|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611055|NCT01012167|P2|Participant Flow|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611056|NCT01012167|P1|Participant Flow|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611057|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611058|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611059|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611060|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611061|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611062|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611063|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611064|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611065|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611066|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611067|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611068|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611069|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611070|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611071|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611072|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611073|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611074|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611075|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611076|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611077|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611078|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611079|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611080|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611081|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611082|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611083|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611084|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611085|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611086|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611087|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611088|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611089|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611090|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611091|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611092|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611093|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611094|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611095|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611096|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611097|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611098|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611099|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611100|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611101|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611102|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611103|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611104|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611105|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611106|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611107|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611108|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611109|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611110|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611111|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611112|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611113|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611114|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611115|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611116|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611117|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611118|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611119|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611120|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611121|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611122|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611123|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611124|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611125|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611126|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611127|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611128|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611129|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611130|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611131|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611132|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
627936|NCT01059760|O2|Outcome|Change While Fasting|
611133|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611134|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611135|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611136|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611137|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611138|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611139|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611140|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611141|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611142|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611143|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611144|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611145|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611146|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611147|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611148|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611149|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611150|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611659|NCT01019928|E2|Reported Event|Placebo|
611151|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611152|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611153|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611154|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611155|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611156|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611157|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611158|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611159|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611160|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611161|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611162|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611163|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611164|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611165|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611166|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611167|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611168|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611169|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611170|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611171|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611172|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611173|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611174|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611175|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611176|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611177|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611178|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611179|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611180|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611181|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611182|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611183|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611184|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611185|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611186|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611187|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611188|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611189|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611190|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611191|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611192|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611193|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611194|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611195|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611196|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611197|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611198|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611199|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611200|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611201|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611202|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611203|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611204|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611205|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611206|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611207|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611208|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611209|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611210|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611211|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611212|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611213|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611214|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611215|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611216|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611217|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611218|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611219|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611220|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611221|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611222|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611223|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611224|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611225|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611226|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611227|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611228|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611229|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611230|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611231|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611232|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611233|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611234|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611235|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611236|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611237|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611741|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611238|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611239|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611240|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611241|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611242|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611243|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611244|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611245|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611246|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin.
611247|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611248|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611249|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611250|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611251|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611252|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611660|NCT01019928|E1|Reported Event|AZD1386 95 mg|
611253|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611254|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611255|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611256|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611257|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611258|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611259|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611260|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611261|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611262|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611263|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611264|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611265|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611266|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611267|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611268|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611269|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611270|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611271|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611272|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611273|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611274|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611275|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611276|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611277|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611278|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611279|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611280|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611281|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611282|NCT01012167|O3|Outcome|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
611326|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
611283|NCT01012167|O2|Outcome|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
611284|NCT01012167|O1|Outcome|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
611285|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611286|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611287|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611288|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611289|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611290|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611291|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611292|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611293|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611294|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611295|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611296|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611661|NCT01019980|B3|Baseline|Total|Total of all reporting groups
611297|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611298|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611299|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611300|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611301|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611302|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611303|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
611304|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
611305|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
611306|NCT01012167|E3|Reported Event|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
611307|NCT01012167|E2|Reported Event|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
611308|NCT01012167|E1|Reported Event|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
611309|NCT01012219|B1|Baseline|All Participants|Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
611310|NCT01012219|P1|Participant Flow|All Participants|Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
611311|NCT01012219|O2|Outcome|Clopidogrel + Aspirin|Participants from Periods 1 and 2
611312|NCT01012219|O1|Outcome|Clopidogrel + Aspirin +Laropiprant|Participants from Periods 1 and 2
611313|NCT01012219|E3|Reported Event|Laropiprant + Niacin|Participants from Period 3
611314|NCT01012219|E2|Reported Event|Clopidogrel + Aspirin|Participants from Periods 1 and 2
611315|NCT01012219|E1|Reported Event|Laropiprant + Clopidrogel + Aspirin|Participants from Periods 1 and 2
611316|NCT01012245|B5|Baseline|Total|Total of all reporting groups
611317|NCT01012245|B4|Baseline|Other Medication|Subjects with other or no hypotensive therapy at baseline visit
611318|NCT01012245|B3|Baseline|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
611319|NCT01012245|B2|Baseline|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit
611320|NCT01012245|B1|Baseline|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
611321|NCT01012245|P1|Participant Flow|Subjects With Glaucoma and Ocular Hypertension|All subjects group: documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups: Xalatan®: subjects with Xalatan® (latanoprost) monotherapy at baseline visit; Betablockers: subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit; Xalacom®: subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit; other medications: subjects with other or no hypotensive therapy at baseline visit.
611322|NCT01012245|O2|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
611323|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
611324|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
611325|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
611327|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
611328|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
611329|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
611330|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
611331|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
611332|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
611333|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
611334|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
611335|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
611336|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
611337|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
611338|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
611339|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
611340|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
611341|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
611342|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
611343|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
611344|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
611345|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
611346|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
611347|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
611348|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
611349|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
611350|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
611351|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
611352|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
611353|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
611354|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
611355|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
611356|NCT01012245|E1|Reported Event|All Subjects|Subjects with documented diagnosis of glaucoma or ocular hypertension at baseline visit.
611357|NCT01012258|B1|Baseline|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
611358|NCT01012258|P1|Participant Flow|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
611359|NCT01012258|O1|Outcome|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
611360|NCT01012258|O1|Outcome|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
611420|NCT01012362|O1|Outcome|All Participants|All participants who received at least one cycle of one of the following 4 dose levels: Dose Level 1: Pazopanib 400mg - Ixabepilone 32mg/m2; Dose Level 2: Pazopanib 400mg - Ixabepilone 40mg/m2; Dose Level 3: Pazopanib 600mg - Ixabepilone 32 mg/m2; or Dose Level 4: Pazopanib 800mg - Ixabepilone 32 mg//m2.
611361|NCT01012258|E2|Reported Event|Cetuximab: Late Phase|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval. Late phase, i.e. adverse events which occur or worsen more than 60 days after the last trial treatment administration (cetuximab or radiotherapy), and before end of trial.
611362|NCT01012258|E1|Reported Event|Cetuximab: Treatment Emergent Phase|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval. Treatment emergent phase, i.e. treatment-emergent adverse events (TEAEs, adverse events which occur or worsen on the first dosing day of trial treatment and until 60 days after the last trial treatment administration (cetuximab or radiotherapy).
611363|NCT01012297|B3|Baseline|Total|Total of all reporting groups
611386|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611387|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611364|NCT01012297|B2|Baseline|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC"
611365|NCT01012297|B1|Baseline|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV"
611366|NCT01012297|P2|Participant Flow|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC"
611367|NCT01012297|P1|Participant Flow|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV"
611368|NCT01012297|O2|Outcome|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC"
611369|NCT01012297|O1|Outcome|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV"
611370|NCT01012297|O2|Outcome|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC"
611371|NCT01012297|O1|Outcome|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV"
611372|NCT01012297|O2|Outcome|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC"
611373|NCT01012297|O1|Outcome|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV"
611374|NCT01012297|O2|Outcome|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC"
611375|NCT01012297|O1|Outcome|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV"
611376|NCT01012297|E2|Reported Event|Arm II|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC"
611377|NCT01012297|E1|Reported Event|Arm I|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV"
611378|NCT01012323|B1|Baseline|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611379|NCT01012323|P1|Participant Flow|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611380|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611381|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611382|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611383|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611384|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611385|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611714|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611388|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611389|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611390|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611391|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611392|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611393|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611394|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611395|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611396|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611397|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611398|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611399|NCT01012323|E1|Reported Event|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
611400|NCT01012336|B1|Baseline|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist
611401|NCT01012336|P1|Participant Flow|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
611402|NCT01012336|O1|Outcome|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
611403|NCT01012336|E1|Reported Event|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist
611404|NCT01012362|B6|Baseline|Total|Total of all reporting groups
611405|NCT01012362|B5|Baseline|Arm 2|Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
611406|NCT01012362|B4|Baseline|Arm 1: Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
611407|NCT01012362|B3|Baseline|Arm 1: Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2
611408|NCT01012362|B2|Baseline|Arm 1: Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
611409|NCT01012362|B1|Baseline|Arm 1: Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
611410|NCT01012362|P5|Participant Flow|Arm 2|Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
611411|NCT01012362|P4|Participant Flow|Arm 1: Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
611412|NCT01012362|P3|Participant Flow|Arm 1: Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2
611413|NCT01012362|P2|Participant Flow|Arm 1: Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
611414|NCT01012362|P1|Participant Flow|Arm 1: Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
611415|NCT01012362|O5|Outcome|Arm 2|Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
611416|NCT01012362|O4|Outcome|Arm 1: Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
611417|NCT01012362|O3|Outcome|Arm 1: Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2
611418|NCT01012362|O2|Outcome|Arm 1: Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
611419|NCT01012362|O1|Outcome|Arm 1: Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
611421|NCT01012362|E5|Reported Event|Arm 2|Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
611422|NCT01012362|E4|Reported Event|Arm 1: Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
611423|NCT01012362|E3|Reported Event|Arm 1: Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2
611424|NCT01012362|E2|Reported Event|Arm 1: Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
611425|NCT01012362|E1|Reported Event|Arm 1: Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
611426|NCT01012388|B1|Baseline|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
611427|NCT01012388|P1|Participant Flow|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
611428|NCT01012388|O1|Outcome|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
611429|NCT01012388|O1|Outcome|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
611430|NCT01012388|E1|Reported Event|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
611431|NCT01012414|B1|Baseline|Enrolled|Total number participants consentedand enrolled
611432|NCT01012414|P1|Participant Flow|All Participants|The participants could have been randomized to one of the 2 arms; study drug or placebo. The study was never unblinded before termination.
611433|NCT01012414|O1|Outcome|All Participants|No arm/group title is provided
611434|NCT01012414|O1|Outcome|All Participants|No arm/group title is provided
611435|NCT01012414|O1|Outcome|Alll Participants|no arm /group title is provided as there was no enrollment.
611436|NCT01012414|O1|Outcome|All Participants|no arm /group title is provided as there was no enrollment.
611437|NCT01012414|E1|Reported Event|All Participants|All participants in the study.
611438|NCT01012440|B1|Baseline|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.
MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
611439|NCT01012440|P1|Participant Flow|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.
MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
611440|NCT01012440|O1|Outcome|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.
MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
611441|NCT01012440|E1|Reported Event|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.
MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
611442|NCT01012622|B1|Baseline|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611443|NCT01012622|P1|Participant Flow|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611444|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611445|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611446|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611447|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611742|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611448|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611449|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611450|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611451|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611474|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
611452|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611453|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611454|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611455|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611456|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611457|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611458|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611459|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611460|NCT01012622|E1|Reported Event|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
611461|NCT01012661|B1|Baseline|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
611462|NCT01012661|P1|Participant Flow|Radiesse® Mixed With Lidocaine & Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl). The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face).
611463|NCT01012661|O2|Outcome|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
611464|NCT01012661|O1|Outcome|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
611465|NCT01012661|O2|Outcome|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
611466|NCT01012661|O1|Outcome|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
611467|NCT01012661|E2|Reported Event|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
611468|NCT01012661|E1|Reported Event|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
611469|NCT01012674|B1|Baseline|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.
Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
611470|NCT01012674|P1|Participant Flow|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.
Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
611471|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
611472|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
611473|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
611475|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
611476|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
611477|NCT01012674|E4|Reported Event|Patients Discontinued Without Dotarem Administration|Patients withdrawn from the study before Dotarem IV administration whatever the reason
611478|NCT01012674|E3|Reported Event|Computerized Tomography Angiography (CTA)|Patients benefiting from CT angiography after the IV administration of an iodinated contrast medium
611479|NCT01012674|E2|Reported Event|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
611480|NCT01012674|E1|Reported Event|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
611481|NCT01012713|B1|Baseline|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser
Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12
Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12
Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
611482|NCT01012713|P1|Participant Flow|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser
Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12
Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12
Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in the Psoriasis Area and Severity Index thereafter."
611483|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser
Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12
Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12
Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than a 75% reduction in Psoriasis Area and Severity Index."
611484|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser
Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12
Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12
Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
611485|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser
Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12
Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12
Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
611486|NCT01012713|E1|Reported Event|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser
Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12
Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12
Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
611487|NCT01012739|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received indacaterol 150 µg via the Concept1 dry-powder inhaler (DPI), indacaterol 60 µg via the Simoon DPI, indacaterol 120 µg via the Simoon DPI, and placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611488|NCT01012739|P4|Participant Flow|Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg|In treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611529|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611489|NCT01012739|P3|Participant Flow|Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg|In treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611490|NCT01012739|P2|Participant Flow|Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo|In treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611518|NCT01012765|B1|Baseline|Safety Set|The safety set included all participants who received at least one dose of study medication during at least one study period.
611563|NCT01012947|O5|Outcome|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward.
613170|NCT01010750|O2|Outcome|MAS-IR 20 mg|
611491|NCT01012739|P1|Participant Flow|Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg|In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611492|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611493|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611494|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received Indacaterol 150 μg via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611495|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611496|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611497|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received Indacaterol 150 μg via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611498|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611499|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611500|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611530|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611501|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611502|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611503|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611564|NCT01012947|O4|Outcome|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator-initiated visit counseling bimonthly.
613171|NCT01010750|O1|Outcome|LDX 50 mg|
611504|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611505|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611506|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611507|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611508|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611509|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611510|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611511|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611512|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611513|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611514|NCT01012739|E4|Reported Event|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611531|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611515|NCT01012739|E3|Reported Event|Indacaterol 120 μg|Patients received indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611516|NCT01012739|E2|Reported Event|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611517|NCT01012739|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI)only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
611519|NCT01012765|P6|Participant Flow|Tiotropium - Indacaterol - Placebo|In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611520|NCT01012765|P5|Participant Flow|Placebo - Tiotropium - Indacaterol|In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611521|NCT01012765|P4|Participant Flow|Placebo - Indacaterol - Tiotropium|In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611522|NCT01012765|P3|Participant Flow|Indacaterol - Tiotropium - Placebo|In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611523|NCT01012765|P2|Participant Flow|Indacaterol - Placebo - Tiotropium|In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611524|NCT01012765|P1|Participant Flow|Tiotropium - Placebo - Indacaterol|In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611525|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611526|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611527|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611528|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611555|NCT01012947|B3|Baseline|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
611810|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611532|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611533|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611534|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611535|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611536|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611537|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611538|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611539|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611540|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611541|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611542|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611543|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611544|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611545|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611546|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611547|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611548|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611549|NCT01012765|E3|Reported Event|Tiotropium 18ug|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611550|NCT01012765|E2|Reported Event|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611551|NCT01012765|E1|Reported Event|Indacaterol 150ug|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
611552|NCT01012947|B6|Baseline|Total|Total of all reporting groups
611553|NCT01012947|B5|Baseline|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
611554|NCT01012947|B4|Baseline|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
611556|NCT01012947|B2|Baseline|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
611557|NCT01012947|B1|Baseline|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
611558|NCT01012947|P5|Participant Flow|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
611559|NCT01012947|P4|Participant Flow|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
611560|NCT01012947|P3|Participant Flow|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
611561|NCT01012947|P2|Participant Flow|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
611562|NCT01012947|P1|Participant Flow|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
611622|NCT01019928|P1|Participant Flow|First AZD1386, Then Washout, Then Placebo|
611565|NCT01012947|O3|Outcome|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
611566|NCT01012947|O2|Outcome|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
611567|NCT01012947|O1|Outcome|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
611568|NCT01012947|E5|Reported Event|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
611569|NCT01012947|E4|Reported Event|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
611570|NCT01012947|E3|Reported Event|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
611571|NCT01012947|E2|Reported Event|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
611572|NCT01012947|E1|Reported Event|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
611573|NCT01012973|B3|Baseline|Total|Total of all reporting groups
611574|NCT01012973|B2|Baseline|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
611575|NCT01012973|B1|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
611576|NCT01012973|P2|Participant Flow|Sham Treatment First, Then Aflibercept Injection|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
611577|NCT01012973|P1|Participant Flow|Aflibercept Injection First, Then Aflibercept Injection|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
611578|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
611579|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
611580|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
611581|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
611739|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611582|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
611583|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
611584|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
611585|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
611586|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
611623|NCT01019928|O2|Outcome|Placebo|
611624|NCT01019928|O1|Outcome|AZD1386 95 mg|
611587|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
611588|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
611589|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
611590|NCT01012973|E6|Reported Event|Sham Treatment Then Aflibercept Injection (Until Week 68)|Participants on sham treatment switched to IAI, received a 2 mg dose of IAI at Week 52 and depending on the study retreatment criteria at Week 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
611591|NCT01012973|E5|Reported Event|Aflibercept Injection Continued (Until Week 68)|Participants on IAI who continued the study drug until Week 52, received 2 mg dose of IAI depending on the study retreatment criteria at Week 52, 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
611592|NCT01012973|E4|Reported Event|Sham Treatment (Until Week 48)|Participants who continued the study drug until Week 24 received sham treatment administered every 4 weeks from Week 24 to Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
611593|NCT01012973|E3|Reported Event|Aflibercept Injection (Until Week 48)|Participants who continued the study drug until Week 24 received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
611594|NCT01012973|E2|Reported Event|Sham Treatment (Until Week 20)|Participants received sham treatment administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
611595|NCT01012973|E1|Reported Event|Aflibercept Injection (Until Week 20)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
611596|NCT01012999|B1|Baseline|Intranasal Sufentanil, Pain Relief|"Patients with a suspected acute bony injury to an extremity and in moderate to severe pain.
Intranasal administration, 0.5 mcg/kg to an extremity and in moderate to severe pain, one time dose."
611597|NCT01012999|P1|Participant Flow|Intranasal Sufentanil, Pain Relief|"Patients with a suspected acute bony injury to an extremity and in moderate to severe pain.
Intranasal administration, 0.5 mcg/kg, one time dose."
611598|NCT01012999|O1|Outcome|Intranasal Sufentanil, Pain Relief|Patients with a suspected acute bony injury to an extremity and in moderate to severe pain
611599|NCT01012999|E1|Reported Event|Intranasal Sufentanil, Pain Relief|Patients with a suspected acute bony injury to an extremity and in moderate to severe pain
611600|NCT01013194|B3|Baseline|Total|Total of all reporting groups
611601|NCT01013194|B2|Baseline|Control Patients|Patients with end-stage chronic liver disease on standard therapy in waiting list for liver transplantation.
611602|NCT01013194|B1|Baseline|Treated Patients|Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells.
611603|NCT01013194|P2|Participant Flow|Control Group|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
611604|NCT01013194|P1|Participant Flow|Treated Patients|"Cell source: Non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.
Infusion technique: Isolation and incannulation of the femoral artery.Splenic artery infusion under radiological guidance.
Cell infusion: between 5x10^8 and 10x10^8 cells. Number of sessions: up to 2."
611605|NCT01013194|O2|Outcome|Control Patients|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
611740|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611606|NCT01013194|O1|Outcome|Treated Patients|Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells.
611607|NCT01013194|O2|Outcome|Control Group|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
611608|NCT01013194|O1|Outcome|Treated Patients|Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells
611609|NCT01013194|O2|Outcome|Control Patients|Patients with end-stage chronic liver disease in waiting list for Liver Transplantation on standard therapy
611610|NCT01013194|O1|Outcome|Treated Patients|Patients with end-stage chronic liver disease in waiting list for Liver Transplantation treated with hFLCTx
611611|NCT01013194|E2|Reported Event|Control Group|Patients with end-stage chronic liver disease in waiting list for liver transplantation.
611612|NCT01013194|E1|Reported Event|Treated Patients|Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.
611613|NCT01013207|B1|Baseline|All Participants|
611614|NCT01013207|P1|Participant Flow|All Participants|
611615|NCT01013207|O1|Outcome|All Participants|
611616|NCT01013207|O1|Outcome|All Participants|
611617|NCT01013207|E1|Reported Event|All Participants|
611618|NCT01019928|B3|Baseline|Total|Total of all reporting groups
611619|NCT01019928|B2|Baseline|Placebo|
611620|NCT01019928|B1|Baseline|AZD1386 95 mg|
611621|NCT01019928|P2|Participant Flow|First Placebo, Then Washout, Then AZD1386|
611625|NCT01019928|O2|Outcome|Placebo|
611662|NCT01019980|B2|Baseline|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
611663|NCT01019980|B1|Baseline|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
611664|NCT01019980|P2|Participant Flow|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
611665|NCT01019980|P1|Participant Flow|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
611666|NCT01019980|O2|Outcome|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
611667|NCT01019980|O1|Outcome|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
611668|NCT01019980|E2|Reported Event|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
611669|NCT01019980|E1|Reported Event|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
611670|NCT01020006|B4|Baseline|Total|Total of all reporting groups
611671|NCT01020006|B3|Baseline|Gemcitabine/Part B|
611672|NCT01020006|B2|Baseline|(PCI-27483 + Gemcitabine)/Part B|
611673|NCT01020006|B1|Baseline|(PCI-27483 + Gemcitabine)/Part A|
611674|NCT01020006|P3|Participant Flow|Gemcitabine/Part B|Subjects in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.
611675|NCT01020006|P2|Participant Flow|PCI-27483 + Gemcitabine/Part B|Part B is a randomized arm to evaluate safety and efficacy. Subjects received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.
611676|NCT01020006|P1|Participant Flow|PCI-27483 + Gemcitabine/Part A|Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.
611677|NCT01020006|O3|Outcome|Gemcitabine/Part B|
611678|NCT01020006|O2|Outcome|(PCI-27483 + Gemcitabine)/Part B|
611679|NCT01020006|O1|Outcome|(PCI-27483 + Gemcitabine)/Part A|
611680|NCT01020006|E3|Reported Event|Gemcitabine/Part B|"Patients in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.
All treated subjects in this group experienced at least one treatment-emergent adverse event."
611681|NCT01020006|E2|Reported Event|(PCI-27483 + Gemcitabine)/Part B|"Part B is a randomized arm to evaluate safety and efficacy. Patients received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.
All treated subjects in this group experienced at least one treatment-emergent adverse event."
611682|NCT01020006|E1|Reported Event|(PCI-27483 + Gemcitabine)/Part A|"Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, patients received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.
All treated subjects in this group experienced at least one treatment-emergent adverse event."
611683|NCT01020019|B3|Baseline|Total|Total of all reporting groups
611684|NCT01020019|B2|Baseline|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
611685|NCT01020019|B1|Baseline|Placebo|"Lofex. matched placebo Dronabinol placebo
Placebo: Placebo control"
611686|NCT01020019|P2|Participant Flow|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
611687|NCT01020019|P1|Participant Flow|Placebo|"Lofex. matched placebo Dronabinol placebo
Placebo: Placebo control"
611688|NCT01020019|O2|Outcome|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
611689|NCT01020019|O1|Outcome|Placebo|"Lofex. matched placebo Dronabinol placebo
Placebo: Placebo control"
611690|NCT01020019|E2|Reported Event|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
611691|NCT01020019|E1|Reported Event|Placebo|"Lofex. matched placebo Dronabinol placebo
Placebo: Placebo control"
611692|NCT01020123|B8|Baseline|Total|Total of all reporting groups
611693|NCT01020123|B7|Baseline|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611694|NCT01020123|B6|Baseline|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611695|NCT01020123|B5|Baseline|Placebo|Placebo add on to metformin
611696|NCT01020123|B4|Baseline|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611697|NCT01020123|B3|Baseline|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611698|NCT01020123|B2|Baseline|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611699|NCT01020123|B1|Baseline|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611700|NCT01020123|P7|Participant Flow|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611701|NCT01020123|P6|Participant Flow|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611702|NCT01020123|P5|Participant Flow|Placebo|Placebo add on to metformin
611703|NCT01020123|P4|Participant Flow|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611704|NCT01020123|P3|Participant Flow|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611705|NCT01020123|P2|Participant Flow|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611706|NCT01020123|P1|Participant Flow|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611707|NCT01020123|O5|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611708|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611709|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611710|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611711|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611712|NCT01020123|O5|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611713|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611715|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611716|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611717|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611718|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611719|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611720|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611721|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611722|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611723|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611724|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611725|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611726|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611727|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611728|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611729|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611730|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611731|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611732|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611733|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611734|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611735|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611736|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611737|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611738|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611743|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611744|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611745|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611746|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611747|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611748|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611749|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611750|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611751|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611752|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611753|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611754|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611755|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611756|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611757|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611758|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611759|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611760|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611761|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611762|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611763|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611764|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611765|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611766|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611767|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611768|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611769|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611770|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611771|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611772|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611773|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611774|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611775|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611776|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611777|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611778|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611779|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611780|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611781|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611782|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611783|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611784|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611785|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
613172|NCT01010750|O3|Outcome|Placebo|
611786|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611787|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611788|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611789|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611790|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611791|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611792|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611793|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611794|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611795|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611796|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611797|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611798|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611799|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611800|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611801|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611802|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611803|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611804|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611805|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611806|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611807|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611808|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611809|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611811|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611812|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611813|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611814|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611815|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611816|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611817|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611818|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611819|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611820|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611821|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611822|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611823|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611824|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611825|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611826|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611827|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611828|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611829|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611830|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611831|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611832|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611833|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611834|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611835|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611836|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611837|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611838|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611839|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611840|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611841|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611842|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611843|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611844|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611845|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611846|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611847|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611848|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611849|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611850|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611851|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611852|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611853|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611854|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611855|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611856|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611857|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611858|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611859|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611860|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611861|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611862|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611863|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611864|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611865|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611866|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611867|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611868|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611869|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611870|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611871|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611872|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611873|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611874|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611875|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611876|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611877|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611878|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611879|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611880|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611881|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611882|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611883|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611884|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611885|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611886|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
611887|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611888|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611889|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611890|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611891|NCT01020123|E7|Reported Event|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
611892|NCT01020123|E6|Reported Event|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
611893|NCT01020123|E5|Reported Event|Placebo|Placebo add on to metformin
611894|NCT01020123|E4|Reported Event|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
611895|NCT01020123|E3|Reported Event|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
611896|NCT01020123|E2|Reported Event|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
611897|NCT01020123|E1|Reported Event|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
611898|NCT01021423|B3|Baseline|Total|Total of all reporting groups
611899|NCT01021423|B2|Baseline|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611900|NCT01021423|B1|Baseline|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611901|NCT01021423|P2|Participant Flow|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611902|NCT01021423|P1|Participant Flow|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611903|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611904|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611905|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611906|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611907|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611908|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611909|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611910|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611911|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611912|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611913|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611914|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611915|NCT01021423|E2|Reported Event|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611916|NCT01021423|E1|Reported Event|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
611917|NCT01021618|B3|Baseline|Total|Total of all reporting groups
611918|NCT01021618|B2|Baseline|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
611919|NCT01021618|B1|Baseline|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
611920|NCT01021618|P2|Participant Flow|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
611921|NCT01021618|P1|Participant Flow|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
611922|NCT01021618|O2|Outcome|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
611923|NCT01021618|O1|Outcome|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
611924|NCT01021618|O2|Outcome|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
611925|NCT01021618|O1|Outcome|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
611926|NCT01021618|E2|Reported Event|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
611927|NCT01021618|E1|Reported Event|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
611928|NCT01021683|B1|Baseline|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611929|NCT01021683|P1|Participant Flow|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611930|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611931|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611932|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611933|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611934|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611963|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611935|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611936|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611937|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611938|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611939|NCT01021683|E1|Reported Event|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
611940|NCT01021761|B4|Baseline|Total|Total of all reporting groups
611941|NCT01021761|B3|Baseline|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
611942|NCT01021761|B2|Baseline|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
611943|NCT01021761|B1|Baseline|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
611944|NCT01021761|P3|Participant Flow|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
611945|NCT01021761|P2|Participant Flow|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
611946|NCT01021761|P1|Participant Flow|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
611947|NCT01021761|O3|Outcome|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
611948|NCT01021761|O2|Outcome|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
611949|NCT01021761|O1|Outcome|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
611950|NCT01021761|E3|Reported Event|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
611951|NCT01021761|E2|Reported Event|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
611952|NCT01021761|E1|Reported Event|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
611953|NCT01021813|B3|Baseline|Total|Total of all reporting groups
611954|NCT01021813|B2|Baseline|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611955|NCT01021813|B1|Baseline|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
611956|NCT01021813|P5|Participant Flow|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Phase, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
611957|NCT01021813|P4|Participant Flow|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
611958|NCT01021813|P3|Participant Flow|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received their same dose of suvorexant during a 2-month DB Randomized Discontinuation Phase.
611959|NCT01021813|P2|Participant Flow|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611960|NCT01021813|P1|Participant Flow|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
611961|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase. Following the Treatment Phase, these participants continued on placebo during the 2-month Randomized Discontinuation Phase.
611962|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase. Following the Treatment Phase, these participants were randomized (at baseline) to suvorexant or placebo during the 2-month Randomized Discontinuation Phase.
613173|NCT01010750|O2|Outcome|MAS-IR 20 mg|
611964|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
611965|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611966|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
611967|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
611968|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
611969|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
611970|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
611971|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
611972|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
612016|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
611973|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
611974|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
611975|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
611976|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611977|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
611978|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611979|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
611980|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611981|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
611982|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611983|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
611984|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611985|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
611986|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611987|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
611988|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611989|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
612084|NCT01022112|O5|Outcome|Placebo|TA-7284 Placebo, once daily for 12 weeks
611990|NCT01021813|E8|Reported Event|Placebo (DB Treatment)/Placebo (DB Run-out)/Follow-up|Following treatment with dose-matched placebo during both the 12-Month DB Treatment Period and the DB Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
611991|NCT01021813|E7|Reported Event|Suvorexant (DB Treatment)/Placebo (DB Run-out)/Follow-up|Following treatment with suvorexant during the 12-Month DB Treatment Period and treatment with dose-matched placebo during the DB the Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
611992|NCT01021813|E6|Reported Event|Suvorexant (DB Treatment)/Suvorexant (DB Run-out)/Follow-up|Following treatment with suvorexant during both the 12-Month DB Treatment Period and the DB Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
611993|NCT01021813|E5|Reported Event|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Phase, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
611994|NCT01021813|E4|Reported Event|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
611995|NCT01021813|E3|Reported Event|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received their same dose of suvorexant during a 2-month DB Randomized Discontinuation Phase.
611996|NCT01021813|E2|Reported Event|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
611997|NCT01021813|E1|Reported Event|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
611998|NCT01021852|B9|Baseline|Total|Total of all reporting groups
611999|NCT01021852|B8|Baseline|Placebo/MK-6096 20 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
612000|NCT01021852|B7|Baseline|MK-6096 20 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
612001|NCT01021852|B6|Baseline|Placebo/MK-6096 10 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
612002|NCT01021852|B5|Baseline|MK-6096 10 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
612003|NCT01021852|B4|Baseline|Placebo/MK-6096 5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
612085|NCT01022112|O4|Outcome|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
613174|NCT01010750|O1|Outcome|LDX 50 mg|
612004|NCT01021852|B3|Baseline|MK-6096 5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
612005|NCT01021852|B2|Baseline|Placebo/MK-6096 2.5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
612006|NCT01021852|B1|Baseline|MK-6096 2.5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
612017|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612392|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612007|NCT01021852|P8|Participant Flow|Placebo/MK-6096 20 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
612008|NCT01021852|P7|Participant Flow|MK-6096 20 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
612009|NCT01021852|P6|Participant Flow|Placebo/MK-6096 10 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
612010|NCT01021852|P5|Participant Flow|MK-6096 10 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
612038|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612039|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
612040|NCT01021852|E7|Reported Event|Post-Study/Follow-up|Participants that completed the study or prematurely discontinued during either treatment period received a 14-day (from last dose) follow-up phone call to assess for AEs. The Post-Study/Follow-up period was the period that occurred between study completion/ treatment discontinuation and the 14-day follow-up phone call (14 days after the last dose of double-blind study medication).
612011|NCT01021852|P4|Participant Flow|Placebo/MK-6096 5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
612012|NCT01021852|P3|Participant Flow|MK-6096 5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
612013|NCT01021852|P2|Participant Flow|Placebo/MK-6096 2.5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
612014|NCT01021852|P1|Participant Flow|MK-6096 2.5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
612015|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612018|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612019|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
612020|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612021|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612022|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612023|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612024|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
612025|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612026|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612027|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612028|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612029|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
612030|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612031|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612032|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612033|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612034|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
612035|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612036|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612037|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612041|NCT01021852|E6|Reported Event|Washout|Participants administered single-blind placebo study medication for the first 3 nights of the washout period that occurred between Treatment Period 1 and Treatment Period 2, immediately prior to bedtime. The remaining 11 days of the washout period constituted a drug holiday during which time no study medication was administered.
612042|NCT01021852|E5|Reported Event|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612043|NCT01021852|E4|Reported Event|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612044|NCT01021852|E3|Reported Event|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612045|NCT01021852|E2|Reported Event|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
612046|NCT01021852|E1|Reported Event|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
612047|NCT01021878|B3|Baseline|Total|Total of all reporting groups
612048|NCT01021878|B2|Baseline|Dextrose|"Control group, standard treatment
Dianeal: glucose based dialysis solution"
612049|NCT01021878|B1|Baseline|Icodextrin|"glucose sparing alternative dialysis solution
icodextrin: glucose sparing dialysis solution"
612050|NCT01021878|P2|Participant Flow|Dextrose|"Control group, standard treatment
Dianeal: glucose based dialysis solution
N=27"
612051|NCT01021878|P1|Participant Flow|Icodextrin|"glucose sparing alternative dialysis solution
icodextrin: glucose sparing dialysis solution
N=33"
612052|NCT01021878|O2|Outcome|Dextrose|"dianeal, Control group, standard treatment
Dianeal: glucose based dialysis solution"
612053|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution
icodextrin: glucose sparing dialysis solution"
612054|NCT01021878|O2|Outcome|Dextrose|"dianeal, Control group, standard treatment
Dianeal: glucose based dialysis solution"
612055|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution
icodextrin: glucose sparing dialysis solution"
612056|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment
Dianeal: glucose based dialysis solution
There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
612129|NCT01022398|B3|Baseline|Total|Total of all reporting groups
612057|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution
icodextrin: glucose sparing dialysis solution
There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
612058|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment
Dianeal: glucose based dialysis solution"
612059|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution
icodextrin: glucose sparing dialysis solution"
612060|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment
Dianeal: glucose based dialysis solution"
612061|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution
icodextrin: glucose sparing dialysis solution"
612062|NCT01021878|E2|Reported Event|Dextrose|"Control group, standard treatment
Dianeal: glucose based dialysis solution
There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
612063|NCT01021878|E1|Reported Event|Icodextrin|"glucose sparing alternative dialysis solution
icodextrin: glucose sparing dialysis solution
There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
612064|NCT01022073|B3|Baseline|Total|Total of all reporting groups
612065|NCT01022073|B2|Baseline|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
612066|NCT01022073|B1|Baseline|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
612067|NCT01022073|P2|Participant Flow|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
612068|NCT01022073|P1|Participant Flow|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
612069|NCT01022073|O2|Outcome|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
612070|NCT01022073|O1|Outcome|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
612071|NCT01022073|E2|Reported Event|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
612072|NCT01022073|E1|Reported Event|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
612073|NCT01022112|B6|Baseline|Total|Total of all reporting groups
612074|NCT01022112|B5|Baseline|Placebo|TA-7284 Placebo, once daily for 12 weeks
612075|NCT01022112|B4|Baseline|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
612076|NCT01022112|B3|Baseline|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
612077|NCT01022112|B2|Baseline|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
612078|NCT01022112|B1|Baseline|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
612079|NCT01022112|P5|Participant Flow|Placebo|TA-7284 Placebo, once daily for 12 weeks
612080|NCT01022112|P4|Participant Flow|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
612081|NCT01022112|P3|Participant Flow|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
612082|NCT01022112|P2|Participant Flow|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
612083|NCT01022112|P1|Participant Flow|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
612086|NCT01022112|O3|Outcome|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
612087|NCT01022112|O2|Outcome|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
612088|NCT01022112|O1|Outcome|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
612089|NCT01022112|E5|Reported Event|Placebo|TA-7284 Placebo, once daily for 12 weeks
612090|NCT01022112|E4|Reported Event|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
612091|NCT01022112|E3|Reported Event|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
612092|NCT01022112|E2|Reported Event|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
612093|NCT01022112|E1|Reported Event|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
612094|NCT01022190|B1|Baseline|Etoricoxib|
612095|NCT01022190|P1|Participant Flow|Etoricoxib, 90 mg, Orally, Ones a Day|Patients who underwent total hip arthroplasty were administered Etoricoxib, 90 mg, orally, one a day for a 7 day period to prevent heterotopic ossification of the hip joint after the operation.
612096|NCT01022190|O1|Outcome|Etoricoxib, 90 mg, Orally, One a Day for 7 Days Period|Etoricoxib, 90 mg, which was administered orally, for a 7-day period to all participants.
612097|NCT01022190|E1|Reported Event|Etoricoxib|
612098|NCT01022203|B3|Baseline|Total|Total of all reporting groups
612099|NCT01022203|B2|Baseline|Arm 2|"Educational Intervention.
PTSD Family Education: Education about PTSD for couples."
612100|NCT01022203|B1|Baseline|Arm 1|"Couple's Therapy Intervention
Structured Approach Therapy: Couple's Therapy for PTSD"
612101|NCT01022203|P2|Participant Flow|PTSD Family Education|"Educational Intervention.
PTSD Family Education: Education about PTSD for couples."
612102|NCT01022203|P1|Participant Flow|Structured Approach Therapy|"Couple's Therapy Intervention
Structured Approach Therapy: Couple's Therapy for PTSD"
612103|NCT01022203|O2|Outcome|PTSD Family Education|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
612104|NCT01022203|O1|Outcome|Structured Approach Therapy|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
612105|NCT01022203|O2|Outcome|PTSD Family Education|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
612106|NCT01022203|O1|Outcome|Structured Approach Therapy|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
612107|NCT01022203|O2|Outcome|PTSD Family Education|Veterans participate in pre-treatment assessment; post-treatment assessment within one week week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
612108|NCT01022203|O1|Outcome|Structured Approach Therapy|Veterans participate in pre-treatment assessment; post-treatment assessment within one week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
612109|NCT01022203|E2|Reported Event|PTSD Family Education (PFE)|"Couple-Based Education called PTSD Family Education (PFE) teaches couple about PTSD symptoms, related problems, and treatment.
PTSD Family Education (PFE): PTSD Family Education (PFE) provides education for veterans with PTSD and their partners explaining the signs and symptoms of PTSD; psychological problems that are comorbid with PTSD; and treatments for PTSD. Skills training and psychotherapy are not included."
612110|NCT01022203|E1|Reported Event|Structured Approach Therapy (SAT)|"Couple-Based Intervention called Structured Approach Therapy (SAT) provides skills training to couple so they can reduce PTSD.
Structured Approach Therapy (SAT): Structured Approach Therapy (SAT) intervention includes education about the impact of PTSD on relationships; skills training to teach couples recognize and stop avoidance behavior; behavior activation training; emotion regulation training; and a couple-based intervention to teach veterans with PTSD to identify and disclose trauma memories and related emotions to their partners. The couple is then trained to support disclosure while practicing empathic communication."
612111|NCT01022242|B3|Baseline|Total|Total of all reporting groups
612112|NCT01022242|B2|Baseline|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
612113|NCT01022242|B1|Baseline|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
Placebo is a physiological sodium chloride solution, which is clear and colourless."
612114|NCT01022242|P2|Participant Flow|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
PXL01: PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
612115|NCT01022242|P1|Participant Flow|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
Placebo: Placebo is a physiological sodium chloride solution, which is clear and colourless."
612116|NCT01022242|O2|Outcome|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
613175|NCT01010750|O3|Outcome|Placebo|
612117|NCT01022242|O1|Outcome|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
Placebo is a physiological sodium chloride solution, which is clear and colourless."
612118|NCT01022242|E2|Reported Event|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
612119|NCT01022242|E1|Reported Event|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
Placebo is a physiological sodium chloride solution, which is clear and colourless."
612120|NCT01022307|B3|Baseline|Total|Total of all reporting groups
612121|NCT01022307|B2|Baseline|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. 24 underwent multimodal MR imaging.
612122|NCT01022307|B1|Baseline|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
612123|NCT01022307|P2|Participant Flow|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI.
612124|NCT01022307|P1|Participant Flow|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
612125|NCT01022307|O2|Outcome|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. Two were excluded because of evidence of malingering.
612126|NCT01022307|O1|Outcome|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
612127|NCT01022307|E2|Reported Event|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. 24 underwent multimodal MR imaging.
612128|NCT01022307|E1|Reported Event|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
612130|NCT01022398|B2|Baseline|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
612131|NCT01022398|B1|Baseline|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
612132|NCT01022398|P2|Participant Flow|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
612133|NCT01022398|P1|Participant Flow|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
612134|NCT01022398|O2|Outcome|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
612135|NCT01022398|O1|Outcome|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
612136|NCT01022398|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
612137|NCT01022502|B1|Baseline|All Participants (Refined/Crude Ointment)|Two symmetrically comparable plaques on each participant were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Photographs of the lesions were taken and lesion severity was evaluated at baseline and at week 2, 4, 6, and 8.
612138|NCT01022502|P1|Participant Flow|All Participants|In all participants, two bilateral symmetric plaques were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Participants were instructed to avoid cross-contamination between the two treatment sites by washing hands throughly between applications. Treatment was performed until complete clearing, up to a maxmum period of 8 weeks.
612139|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
612140|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
612141|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
612142|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
612143|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
612144|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
612145|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
612146|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
612147|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
612148|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
612149|NCT01022502|E2|Reported Event|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil, filtering, then mixing with petroleum jelly and wax.
613176|NCT01010750|O2|Outcome|MAS-IR 20 mg|
612150|NCT01022502|E1|Reported Event|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil,petroleum jelly and wax.
612151|NCT01022567|B3|Baseline|Total|Total of all reporting groups
612152|NCT01022567|B2|Baseline|Antibiotic Treatment|"Ertapenem 1 g i.v. x 1 three days
Ertapenem: ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o."
612153|NCT01022567|B1|Baseline|Operative Treatment|"Regular open appendicectomy
Appendicectomy: Standard appendicectomy"
612154|NCT01022567|P2|Participant Flow|Antibiotic Therapy|Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days.
612155|NCT01022567|P1|Participant Flow|Appendectomy|Open appendectomy
612156|NCT01022567|O2|Outcome|Antibiotic Therapy|
612157|NCT01022567|O1|Outcome|Appendectomy|
612158|NCT01022567|E2|Reported Event|Antibiotic Therapy|Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days
612159|NCT01022567|E1|Reported Event|Appendectomy|Open appendectomy
612160|NCT01022762|B3|Baseline|Total|Total of all reporting groups
612161|NCT01022762|B2|Baseline|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612162|NCT01022762|B1|Baseline|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612163|NCT01022762|P2|Participant Flow|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612164|NCT01022762|P1|Participant Flow|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612165|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612166|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612167|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612168|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612169|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612170|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612171|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612172|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612173|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612174|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612175|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612176|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612177|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612178|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612179|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612180|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612181|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612182|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612183|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612184|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612185|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612186|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612187|NCT01022762|E2|Reported Event|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
612188|NCT01022762|E1|Reported Event|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
612216|NCT01023035|E3|Reported Event|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
612189|NCT01022996|B1|Baseline|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
612190|NCT01022996|P1|Participant Flow|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
612191|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
612205|NCT01023035|B3|Baseline|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
612253|NCT01023178|O1|Outcome|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
Progesterone, micronized: Given starting at 18 months"
612393|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612192|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
612193|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
612194|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
612195|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
612196|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
613177|NCT01010750|O1|Outcome|LDX 50 mg|
612197|NCT01022996|E1|Reported Event|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
612198|NCT01023022|B1|Baseline|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.
The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.
Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
612199|NCT01023022|P1|Participant Flow|Medtronic CareLink® Network|"Patients with Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, who will be monitored by the Medtronic CareLink® System.
The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.
Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
612200|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.
The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.
Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
612201|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.
The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.
Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
612202|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.
The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.
Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
612203|NCT01023022|E1|Reported Event|Patients With Implanted ICD or CRT-D Devices|Patients with implanted ICD or CRT-D devices, who will be monitored via CareLink Network System
612204|NCT01023035|B4|Baseline|Total|Total of all reporting groups
612206|NCT01023035|B2|Baseline|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
612207|NCT01023035|B1|Baseline|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
612208|NCT01023035|P3|Participant Flow|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
612209|NCT01023035|P2|Participant Flow|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
612210|NCT01023035|P1|Participant Flow|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
612211|NCT01023035|O3|Outcome|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
612212|NCT01023035|O2|Outcome|Erythropoietin Use Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
612213|NCT01023035|O1|Outcome|Ribavirin Dose Reduction Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
612214|NCT01023035|O2|Outcome|Erythropoietin Use Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
612215|NCT01023035|O1|Outcome|Ribavirin Dose Reduction Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
612274|NCT01023256|P1|Participant Flow|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612217|NCT01023035|E2|Reported Event|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
612218|NCT01023035|E1|Reported Event|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
612219|NCT01023061|B1|Baseline|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
abiraterone acetate: Given orally
prednisone: Given orally
leuprolide acetate: Given via injection
laboratory biomarker analysis: Correlative study
external beam radiation therapy: Undergo radiotherapy
goserelin acetate: Given via injection"
612220|NCT01023061|P1|Participant Flow|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone daily for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
abiraterone acetate: Given orally
prednisone: Given orally
leuprolide acetate: Given via injection
laboratory biomarker analysis: Correlative study
external beam radiation therapy: Undergo radiotherapy
goserelin acetate: Given via injection"
612221|NCT01023061|O1|Outcome|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
abiraterone acetate: Given PO
prednisone: Given PO
leuprolide acetate: Given via injection
laboratory biomarker analysis: Correlative study
external beam radiation therapy: Undergo radiotherapy
goserelin acetate: Given via injection"
612252|NCT01023178|O2|Outcome|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
Progesterone, micronized: Given starting at 18 months"
612394|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612222|NCT01023061|O1|Outcome|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
abiraterone acetate: Given PO
prednisone: Given PO
leuprolide acetate: Given via injection
laboratory biomarker analysis: Correlative study
external beam radiation therapy: Undergo radiotherapy
goserelin acetate: Given via injection"
612223|NCT01023061|O1|Outcome|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
abiraterone acetate: Given PO
prednisone: Given PO
leuprolide acetate: Given via injection
laboratory biomarker analysis: Correlative study
external beam radiation therapy: Undergo radiotherapy
goserelin acetate: Given via injection"
612224|NCT01023061|E1|Reported Event|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
abiraterone acetate: Given orally
prednisone: Given orally
leuprolide acetate: Given via injection
laboratory biomarker analysis: Correlative study
external beam radiation therapy: Undergo radiotherapy
goserelin acetate: Given via injection"
612225|NCT01023074|B4|Baseline|Total|Total of all reporting groups
612226|NCT01023074|B3|Baseline|MS: Control Activity|"MS group not receiving auditory training, doing control activity
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
612227|NCT01023074|B2|Baseline|MS:Auditory Training|"MS group receiving auditory training
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
612228|NCT01023074|B1|Baseline|Non-MS Control|Non-MS control group
612229|NCT01023074|P3|Participant Flow|MS: Control Activity|"MS group not receiving auditory training, doing control activity
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
612230|NCT01023074|P2|Participant Flow|MS: Auditory Training|"MS group receiving auditory training
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
612231|NCT01023074|P1|Participant Flow|Non-MS Control|Non-MS control group
612232|NCT01023074|O3|Outcome|MS: Control Activity|"MS group not receiving auditory training, doing control activity
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
612233|NCT01023074|O2|Outcome|MS: Auditory Training|"MS group receiving auditory training
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
612234|NCT01023074|O1|Outcome|Non-MS Control|Non-MS control group
612235|NCT01023074|O3|Outcome|MS: Control Activity|MS group not receiving auditory training, doing control activity
612236|NCT01023074|O2|Outcome|MS: Auditory Training|"MS group receiving auditory training
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
612237|NCT01023074|O1|Outcome|Non-MS Control|Non-MS control group
612359|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612238|NCT01023074|O3|Outcome|Arm 3|"MS group not receiving auditory training, doing control activity
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
612239|NCT01023074|O2|Outcome|Arm 2|"MS group receiving auditory training
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
612240|NCT01023074|O1|Outcome|Arm 1|Non-MS control group
612241|NCT01023074|E3|Reported Event|MS: Control Activity|"MS group not receiving auditory training, doing control activity
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
612242|NCT01023074|E2|Reported Event|MS: Auditory Training|"MS group receiving auditory training
Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
612243|NCT01023074|E1|Reported Event|Non-MS Control|Non-MS control group
612244|NCT01023178|B4|Baseline|Total|Total of all reporting groups
612245|NCT01023178|B3|Baseline|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.
Progesterone, micronized: Given starting at 18 months"
612246|NCT01023178|B2|Baseline|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
Progesterone, micronized: Given starting at 18 months"
612247|NCT01023178|B1|Baseline|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
Progesterone, micronized: Given starting at 18 months"
612248|NCT01023178|P3|Participant Flow|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.
Progesterone, micronized: Given starting at 18 months"
612249|NCT01023178|P2|Participant Flow|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
Progesterone, micronized: Given starting at 18 months"
612250|NCT01023178|P1|Participant Flow|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
Progesterone, micronized: Given starting at 18 months"
612251|NCT01023178|O3|Outcome|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.
Progesterone, micronized: Given starting at 18 months"
612295|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
612254|NCT01023178|E3|Reported Event|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.
Progesterone, micronized: Given starting at 18 months"
612255|NCT01023178|E2|Reported Event|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
Progesterone, micronized: Given starting at 18 months"
612256|NCT01023178|E1|Reported Event|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
Progesterone, micronized: Given starting at 18 months"
612257|NCT01023217|B3|Baseline|Total|Total of all reporting groups
612258|NCT01023217|B2|Baseline|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks
Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
612259|NCT01023217|B1|Baseline|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks
Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
612260|NCT01023217|P2|Participant Flow|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks
Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
612261|NCT01023217|P1|Participant Flow|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks
Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
612262|NCT01023217|O2|Outcome|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks
Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
612263|NCT01023217|O1|Outcome|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks
Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
612264|NCT01023217|E2|Reported Event|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks
Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
612265|NCT01023217|E1|Reported Event|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks
Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
612266|NCT01023256|B5|Baseline|Total|Total of all reporting groups
612267|NCT01023256|B4|Baseline|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
612268|NCT01023256|B3|Baseline|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612269|NCT01023256|B2|Baseline|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612270|NCT01023256|B1|Baseline|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612271|NCT01023256|P4|Participant Flow|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
612272|NCT01023256|P3|Participant Flow|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612273|NCT01023256|P2|Participant Flow|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612275|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
612276|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612277|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612278|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612279|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
612280|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612281|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612282|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612283|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
612284|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612285|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612286|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612287|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
612288|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612289|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612290|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612291|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
612292|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612293|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612294|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612389|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612296|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612297|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612298|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612299|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
612300|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612301|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612302|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612303|NCT01023256|O5|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
612304|NCT01023256|O4|Outcome|Pooled Active|All patients receiving MOR103 at any dose
612305|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612306|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612307|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612308|NCT01023256|E5|Reported Event|Pooled Placebo|Pooled placebo group included all patients who were randomized to placebo in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
612309|NCT01023256|E4|Reported Event|Pooled Active|All patients receiving MOR103 at any dose
612310|NCT01023256|E3|Reported Event|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612311|NCT01023256|E2|Reported Event|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612312|NCT01023256|E1|Reported Event|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
612313|NCT01023308|B3|Baseline|Total|Total of all reporting groups
612314|NCT01023308|B2|Baseline|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612315|NCT01023308|B1|Baseline|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612316|NCT01023308|P2|Participant Flow|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612317|NCT01023308|P1|Participant Flow|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612318|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612319|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612320|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612321|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612322|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612323|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612324|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612325|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612326|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612327|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612328|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612329|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612330|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612331|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612390|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612332|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612333|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612334|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612335|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612336|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612337|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612338|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
612339|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612340|NCT01023308|E2|Reported Event|PBO+BTZ|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day..
612341|NCT01023308|E1|Reported Event|PAN+BTZ|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
612342|NCT01023516|B3|Baseline|Total|Total of all reporting groups
612343|NCT01023516|B2|Baseline|Placebo|Matched Placebo Tablets
612344|NCT01023516|B1|Baseline|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612345|NCT01023516|P2|Participant Flow|Placebo|Matched Placebo Tablets
612346|NCT01023516|P1|Participant Flow|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612347|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612348|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612349|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612350|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612351|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612352|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612353|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612354|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612355|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612356|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612357|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612358|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612360|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612361|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612362|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612363|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612364|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612365|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612366|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612367|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612368|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612369|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612370|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612371|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612372|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612373|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612374|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612375|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612376|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612377|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612378|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612379|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612380|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612381|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612382|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612383|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612384|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612385|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612386|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612387|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612388|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612396|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612397|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612398|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612399|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612400|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612401|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612402|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612403|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612404|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612405|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612406|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612407|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612408|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612409|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612410|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612411|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612412|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612413|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612414|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612415|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612416|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612417|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612418|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612419|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612420|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612421|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
612422|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612423|NCT01023516|E2|Reported Event|Placebo|Matched Placebo Tablets
612424|NCT01023516|E1|Reported Event|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
612425|NCT01023568|B4|Baseline|Total|Total of all reporting groups
612426|NCT01023568|B3|Baseline|Truview PCD|"Intubation with the Truview PCD laryngoscope
Truview PCD: Intubation with Truview PCD laryngoscope."
612427|NCT01023568|B2|Baseline|Glidescope|"Intubation with Glidescope laryngoscope
Glidescope: Intubation with Glidescope laryngoscope."
612428|NCT01023568|B1|Baseline|Macintosh Blade|"Intubation with Macintosh blade laryngoscope
Macintosh blade: Intubation with Macintosh blade laryngoscope"
612429|NCT01023568|P3|Participant Flow|Truview PCD|"Intubation with the Truview PCD laryngoscope
Truview PCD: Intubation with Truview PCD laryngoscope."
612430|NCT01023568|P2|Participant Flow|Glidescope|"Intubation with Glidescope laryngoscope
Glidescope: Intubation with Glidescope laryngoscope."
612431|NCT01023568|P1|Participant Flow|Macintosh Blade|"Intubation with Macintosh blade laryngoscope
Macintosh blade: Intubation with Macintosh blade laryngoscope"
612432|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope
Truview PCD: Intubation with Truview PCD laryngoscope."
612433|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope
Glidescope: Intubation with Glidescope laryngoscope."
612509|NCT01023672|O1|Outcome|Armodifinil|150-250 mg armodafinil by mouth daily
612434|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope
Macintosh blade: Intubation with Macintosh blade laryngoscope"
612435|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope
Truview PCD: Intubation with Truview PCD laryngoscope."
612436|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope
Glidescope: Intubation with Glidescope laryngoscope."
612437|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope
Macintosh blade: Intubation with Macintosh blade laryngoscope"
612438|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope
Truview PCD: Intubation with Truview PCD laryngoscope."
612439|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope
Glidescope: Intubation with Glidescope laryngoscope."
612440|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope
Macintosh blade: Intubation with Macintosh blade laryngoscope"
612441|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope
Truview PCD: Intubation with Truview PCD laryngoscope."
612442|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope
Glidescope: Intubation with Glidescope laryngoscope."
612443|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope
Macintosh blade: Intubation with Macintosh blade laryngoscope"
612444|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope
Truview PCD: Intubation with Truview PCD laryngoscope."
612445|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope
Glidescope: Intubation with Glidescope laryngoscope."
612446|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope
Macintosh blade: Intubation with Macintosh blade laryngoscope"
612447|NCT01023568|E3|Reported Event|Truview PCD|"Intubation with the Truview PCD laryngoscope
Truview PCD: Intubation with Truview PCD laryngoscope."
612448|NCT01023568|E2|Reported Event|Glidescope|"Intubation with Glidescope laryngoscope
Glidescope: Intubation with Glidescope laryngoscope."
612449|NCT01023568|E1|Reported Event|Macintosh Blade|"Intubation with Macintosh blade laryngoscope
Macintosh blade: Intubation with Macintosh blade laryngoscope"
612450|NCT01023581|B8|Baseline|Total|Total of all reporting groups
612451|NCT01023581|B7|Baseline|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
612452|NCT01023581|B6|Baseline|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
612453|NCT01023581|B5|Baseline|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
612454|NCT01023581|B4|Baseline|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
612455|NCT01023581|B3|Baseline|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612456|NCT01023581|B2|Baseline|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612457|NCT01023581|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612458|NCT01023581|P7|Participant Flow|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
612459|NCT01023581|P6|Participant Flow|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
612460|NCT01023581|P5|Participant Flow|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
612461|NCT01023581|P4|Participant Flow|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
612462|NCT01023581|P3|Participant Flow|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612463|NCT01023581|P2|Participant Flow|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612464|NCT01023581|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612465|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
612466|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
612467|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
612468|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
612469|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612470|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612471|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612472|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
612473|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
612474|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
612475|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
612476|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612477|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612478|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612479|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
612480|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
612481|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
612482|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
612483|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612484|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612485|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612486|NCT01023581|E7|Reported Event|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
612487|NCT01023581|E6|Reported Event|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
612488|NCT01023581|E5|Reported Event|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
612489|NCT01023581|E4|Reported Event|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
627937|NCT01059760|O1|Outcome|Baseline Value|
612490|NCT01023581|E3|Reported Event|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612491|NCT01023581|E2|Reported Event|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612492|NCT01023581|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
612493|NCT01023659|B4|Baseline|Total|Total of all reporting groups
612494|NCT01023659|B3|Baseline|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
612495|NCT01023659|B2|Baseline|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks"
612496|NCT01023659|B1|Baseline|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.
bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
motivational emails : brief motivational emails, sent weekly for 12 weeks"
612497|NCT01023659|P3|Participant Flow|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
612498|NCT01023659|P2|Participant Flow|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks"
612499|NCT01023659|P1|Participant Flow|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.
bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
motivational emails : brief motivational emails, sent weekly for 12 weeks"
612500|NCT01023659|O1|Outcome|All Eligible Participants|All participants who were eligible to receive medication
612501|NCT01023659|O3|Outcome|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
612502|NCT01023659|O2|Outcome|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks"
612503|NCT01023659|O1|Outcome|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.
bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
motivational emails : brief motivational emails, sent weekly for 12 weeks"
612504|NCT01023659|E3|Reported Event|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
612505|NCT01023659|E2|Reported Event|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks"
612506|NCT01023659|E1|Reported Event|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.
bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
motivational emails : brief motivational emails, sent weekly for 12 weeks"
612507|NCT01023672|B1|Baseline|Armodifinil|150-250 mg armodafinil by mouth daily
612508|NCT01023672|P1|Participant Flow|Armodifinil|150-250 mg armodafinil by mouth daily
612510|NCT01023672|E1|Reported Event|Armodifinil|150-250 mg armodafinil by mouth daily
612511|NCT01023711|B1|Baseline|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
612512|NCT01023711|P1|Participant Flow|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
612513|NCT01023711|O1|Outcome|Inactivated H1N1 Vaccine|Inactivated H1N1 vaccine: 0.5 ml IM into Deltoid region of arm
612514|NCT01023711|O1|Outcome|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
612515|NCT01023711|E1|Reported Event|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
612516|NCT01023724|B3|Baseline|Total|Total of all reporting groups
612517|NCT01023724|B2|Baseline|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
612518|NCT01023724|B1|Baseline|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
612519|NCT01023724|P2|Participant Flow|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
612520|NCT01023724|P1|Participant Flow|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
612521|NCT01023724|O2|Outcome|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
612522|NCT01023724|O1|Outcome|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
612523|NCT01023724|E2|Reported Event|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
612524|NCT01023724|E1|Reported Event|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
612525|NCT01023776|B1|Baseline|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
612526|NCT01023776|P1|Participant Flow|Live Monovalent H1N1 Vaccine|Subjects received 2 doses of vaccine 0.1 ml in each nostril intranasally 28 days apart
612527|NCT01023776|O1|Outcome|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
612528|NCT01023776|O1|Outcome|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
612529|NCT01023776|E1|Reported Event|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
612531|NCT01023815|B4|Baseline|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.
Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
612532|NCT01023815|B3|Baseline|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.
Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
612533|NCT01023815|B2|Baseline|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.
Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.
Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.
Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
612534|NCT01023815|B1|Baseline|Not Randomized Population (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).
Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP)"
612535|NCT01023815|P4|Participant Flow|Randomized: Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.
Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
612536|NCT01023815|P3|Participant Flow|Randomized: Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.
Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
612537|NCT01023815|P2|Participant Flow|Randomized: Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.
Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.
Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.
Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
612538|NCT01023815|P1|Participant Flow|Pre-randomized: Not-randomization Patients (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).
Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP)"
612539|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.
Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
612540|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.
Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
612541|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.
Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
612542|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.
Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
612543|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.
Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
612597|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.
Surgical staples: Surgical staples will be used once for wound closure."
612544|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.
Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
612545|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.
Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
612546|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.
Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
612547|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.
Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
612548|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.
Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
612549|NCT01023815|O3|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.
Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
612550|NCT01023815|O2|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.
Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
612551|NCT01023815|O1|Outcome|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.
Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.
Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.
Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
612583|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid
baclofen: baclofen 10 mg tid"
612552|NCT01023815|E4|Reported Event|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.
Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
612553|NCT01023815|E3|Reported Event|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.
Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.
Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
612554|NCT01023815|E2|Reported Event|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.
Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.
Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.
Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
612555|NCT01023815|E1|Reported Event|Not Randomized Population (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).
This population defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP) and described with respect to baseline characteristics, treatment and outcome variables."
612556|NCT01023841|B3|Baseline|Total|Total of all reporting groups
612557|NCT01023841|B2|Baseline|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612558|NCT01023841|B1|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612936|NCT01009762|O2|Outcome|Placebo|participants receiving placebo (=saline)
612559|NCT01023841|P2|Participant Flow|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612560|NCT01023841|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612561|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612562|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612563|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612564|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612565|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612566|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612567|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612568|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612569|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612570|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612571|NCT01023841|E2|Reported Event|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612572|NCT01023841|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
612573|NCT01008280|B3|Baseline|Total|Total of all reporting groups
612574|NCT01008280|B2|Baseline|Placebo|"placebo given tid
placebo: placebo pill tid"
612575|NCT01008280|B1|Baseline|Baclofen|"baclofen 10 mg po tid
baclofen: baclofen 10 mg tid"
612576|NCT01008280|P2|Participant Flow|Placebo|"placebo given tid
placebo: placebo pill tid"
612577|NCT01008280|P1|Participant Flow|Baclofen|"baclofen 10 mg po tid
baclofen: baclofen 10 mg tid"
612578|NCT01008280|O2|Outcome|Placebo|"placebo given tid
placebo: placebo pill tid"
612579|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid
baclofen: baclofen 10 mg tid"
612580|NCT01008280|O2|Outcome|Placebo|"placebo given tid
placebo: placebo pill tid"
612581|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid
baclofen: baclofen 10 mg tid"
612582|NCT01008280|O2|Outcome|Placebo|"placebo given tid
placebo: placebo pill tid"
612584|NCT01008280|E2|Reported Event|Placebo|"placebo given tid
placebo: placebo pill tid"
612585|NCT01008280|E1|Reported Event|Baclofen|"baclofen 10 mg po tid
baclofen: baclofen 10 mg tid"
612586|NCT01008449|B3|Baseline|Total|Total of all reporting groups
612587|NCT01008449|B2|Baseline|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.
Surgical staples: Surgical staples will be used once for wound closure."
612588|NCT01008449|B1|Baseline|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
612589|NCT01008449|P2|Participant Flow|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.
Surgical staples: Surgical staples will be used once for wound closure."
612590|NCT01008449|P1|Participant Flow|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
612591|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.
Surgical staples: Surgical staples will be used once for wound closure."
612592|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
612593|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.
Surgical staples: Surgical staples will be used once for wound closure."
612594|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
612595|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.
Surgical staples: Surgical staples will be used once for wound closure."
612596|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
612937|NCT01009762|O1|Outcome|Vaccinee|participants receiving the vaccine
612598|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
612599|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.
Surgical staples: Surgical staples will be used once for wound closure."
612600|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
612601|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.
Surgical staples: Surgical staples will be used once for wound closure."
612602|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
612603|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.
Surgical staples: Surgical staples will be used once for wound closure."
612604|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
612605|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.
Surgical staples: Surgical staples will be used once for wound closure."
612606|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
612607|NCT01008449|E2|Reported Event|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.
Surgical staples: Surgical staples will be used once for wound closure."
612608|NCT01008449|E1|Reported Event|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
612609|NCT01008475|B8|Baseline|Total|Total of all reporting groups
612610|NCT01008475|B7|Baseline|Randomized Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612611|NCT01008475|B6|Baseline|Randomized Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
613178|NCT01010750|E3|Reported Event|Placebo|
612612|NCT01008475|B5|Baseline|Randomized Part: SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612613|NCT01008475|B4|Baseline|Safety Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612614|NCT01008475|B3|Baseline|Safety Part: EMD 525797 750 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612615|NCT01008475|B2|Baseline|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612616|NCT01008475|B1|Baseline|Safety Part: EMD 525797 250 mg + Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612938|NCT01009762|E2|Reported Event|Placebo|Participants receiving placebo (saline)
612617|NCT01008475|P7|Participant Flow|Randomized Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612618|NCT01008475|P6|Participant Flow|Randomized Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612619|NCT01008475|P5|Participant Flow|Randomized Part: Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612620|NCT01008475|P4|Participant Flow|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612621|NCT01008475|P3|Participant Flow|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612622|NCT01008475|P2|Participant Flow|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612623|NCT01008475|P1|Participant Flow|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612624|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612625|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612626|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612627|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612628|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612760|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612629|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612630|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612631|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612632|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612633|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612634|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612635|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612689|NCT01008605|O6|Outcome|Caverject 20 Mcg Device, 10.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
612636|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612637|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612638|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612639|NCT01008475|O4|Outcome|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612640|NCT01008475|O3|Outcome|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612677|NCT01008605|B1|Baseline|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
612939|NCT01009762|E1|Reported Event|Vaccinee|"participants receiving the vaccine called AFO-18"
612641|NCT01008475|O2|Outcome|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612642|NCT01008475|O1|Outcome|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612643|NCT01008475|E7|Reported Event|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612644|NCT01008475|E6|Reported Event|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612645|NCT01008475|E5|Reported Event|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612646|NCT01008475|E4|Reported Event|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612690|NCT01008605|O5|Outcome|Caverject 20 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
612913|NCT01009645|P2|Participant Flow|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
612647|NCT01008475|E3|Reported Event|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612648|NCT01008475|E2|Reported Event|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612649|NCT01008475|E1|Reported Event|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
612650|NCT01008553|B1|Baseline|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612651|NCT01008553|P3|Participant Flow|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612652|NCT01008553|P2|Participant Flow|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
613016|NCT01010204|B3|Baseline|Total|Total of all reporting groups
612653|NCT01008553|P1|Participant Flow|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612654|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612655|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612656|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612657|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612691|NCT01008605|O4|Outcome|Caverject 10 Mcg Device, 10 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
612782|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612658|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612659|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612660|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612661|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612662|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612663|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612664|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612756|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612665|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612666|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612667|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612668|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612669|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612783|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612670|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612671|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612672|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612673|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612674|NCT01008553|E3|Reported Event|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612675|NCT01008553|E2|Reported Event|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612676|NCT01008553|E1|Reported Event|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
613081|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
612678|NCT01008605|P1|Participant Flow|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
612679|NCT01008605|O8|Outcome|Caverject 20 Mcg Device, 20.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
612680|NCT01008605|O7|Outcome|Caverject 20 Mcg Device, 15.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
612681|NCT01008605|O6|Outcome|Caverject 20 Mcg Device, 10.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
612682|NCT01008605|O5|Outcome|Caverject 20 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
612683|NCT01008605|O4|Outcome|Caverject 10 Mcg Device, 10 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
612684|NCT01008605|O3|Outcome|Caverject 10 Mcg Device, 7.5 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
612685|NCT01008605|O2|Outcome|Caverject 10 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
612686|NCT01008605|O1|Outcome|Caverject 10 Mcg Device, 2.5 Mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Delivery System to expel Alprostadil 2.5 mcg in a receptacle. Participants did not receive study medication.
612687|NCT01008605|O8|Outcome|Caverject 20 Mcg Device, 20.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
612688|NCT01008605|O7|Outcome|Caverject 20 Mcg Device, 15.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
612784|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612692|NCT01008605|O3|Outcome|Caverject 10 Mcg Device, 7.5 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
612693|NCT01008605|O2|Outcome|Caverject 10 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
612694|NCT01008605|O1|Outcome|Caverject 10 Mcg Device, 2.5 Mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Delivery System to expel Alprostadil 2.5 mcg in a receptacle. Participants did not receive study medication.
612695|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
612696|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
612697|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
612698|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
612699|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
612700|NCT01008605|E1|Reported Event|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
612701|NCT01008618|B1|Baseline|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612757|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612761|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612702|NCT01008618|P3|Participant Flow|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612703|NCT01008618|P2|Participant Flow|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612704|NCT01008618|P1|Participant Flow|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612705|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612706|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612732|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
612785|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612707|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612708|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612709|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612710|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612711|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612712|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612713|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612758|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612714|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612715|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612716|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612717|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612718|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612779|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612719|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612720|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612721|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612722|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612723|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612724|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612725|NCT01008618|E3|Reported Event|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612759|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612726|NCT01008618|E2|Reported Event|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
612727|NCT01008618|E1|Reported Event|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
612728|NCT01009515|B1|Baseline|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
612729|NCT01009515|P1|Participant Flow|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
612730|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
612731|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
612780|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612781|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612733|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
612734|NCT01009515|E1|Reported Event|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
612735|NCT01009554|B3|Baseline|Total|Total of all reporting groups
612736|NCT01009554|B2|Baseline|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612737|NCT01009554|B1|Baseline|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612738|NCT01009554|P2|Participant Flow|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612739|NCT01009554|P1|Participant Flow|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612740|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612741|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612742|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612743|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612744|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612745|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612746|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612747|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612748|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612749|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612750|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612751|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612752|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612753|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612754|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612755|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612805|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612762|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612763|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612764|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612765|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612766|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612767|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612768|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612769|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612770|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612771|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612772|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612773|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612774|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612775|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612776|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612777|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612778|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
613179|NCT01010750|E2|Reported Event|MAS-IR 20 mg|
612786|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612787|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612788|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612789|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612790|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612791|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612792|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612793|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612794|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612795|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612796|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612797|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612798|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612799|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612800|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612801|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612802|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612803|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612804|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612806|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612807|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612808|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612809|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612810|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612811|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612812|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612813|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612814|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612815|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612816|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612817|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612818|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612819|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612820|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612821|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612822|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612823|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612824|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612825|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612826|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612827|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612828|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612829|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612830|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612831|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612832|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612833|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612834|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612835|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612836|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612837|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612838|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612839|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612840|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612841|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612842|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612843|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612844|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612845|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612846|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612847|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612848|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612849|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612850|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612851|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612852|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612853|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612854|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612855|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612856|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612857|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612858|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612859|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612860|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612861|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612862|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612863|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612864|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612865|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612866|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612867|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612868|NCT01009554|E2|Reported Event|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
612869|NCT01009554|E1|Reported Event|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
612870|NCT01009580|B3|Baseline|Total|Total of all reporting groups
612871|NCT01009580|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
612912|NCT01009645|P3|Participant Flow|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
612872|NCT01009580|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
612873|NCT01009580|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
612874|NCT01009580|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
612875|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
612876|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
612877|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
612878|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
612879|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
612880|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
612881|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
612882|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
612883|NCT01009580|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
612884|NCT01009580|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
612885|NCT01009619|B3|Baseline|Total|Total of all reporting groups
612886|NCT01009619|B2|Baseline|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
612887|NCT01009619|B1|Baseline|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
612888|NCT01009619|P2|Participant Flow|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
612889|NCT01009619|P1|Participant Flow|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
612890|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
612891|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
612892|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
612893|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
612894|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
612895|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
612896|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
612897|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
612898|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
612899|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
612900|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
612901|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
612902|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
612903|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
612904|NCT01009619|E2|Reported Event|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
612905|NCT01009619|E1|Reported Event|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
612906|NCT01009645|B5|Baseline|Total|Total of all reporting groups
612907|NCT01009645|B4|Baseline|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
612908|NCT01009645|B3|Baseline|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
612909|NCT01009645|B2|Baseline|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
612910|NCT01009645|B1|Baseline|Fact Only|The educational message used will contain facts only.
612911|NCT01009645|P4|Participant Flow|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
612914|NCT01009645|P1|Participant Flow|Fact Only|The educational message used will contain facts only.
612915|NCT01009645|O4|Outcome|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
612916|NCT01009645|O3|Outcome|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
612917|NCT01009645|O2|Outcome|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
612918|NCT01009645|O1|Outcome|Fact Only|The educational message used will contain facts only.
612919|NCT01009645|O4|Outcome|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
612920|NCT01009645|O3|Outcome|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
612921|NCT01009645|O2|Outcome|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
612922|NCT01009645|O1|Outcome|Fact Only|The educational message used will contain facts only.
612923|NCT01009645|E4|Reported Event|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
612924|NCT01009645|E3|Reported Event|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
612925|NCT01009645|E2|Reported Event|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
612926|NCT01009645|E1|Reported Event|Fact Only|The educational message used will contain facts only.
612927|NCT01009762|B3|Baseline|Total|Total of all reporting groups
612928|NCT01009762|B2|Baseline|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
612929|NCT01009762|B1|Baseline|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
612930|NCT01009762|P2|Participant Flow|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
612931|NCT01009762|P1|Participant Flow|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
612932|NCT01009762|O2|Outcome|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
612933|NCT01009762|O1|Outcome|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
612934|NCT01009762|O2|Outcome|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
612935|NCT01009762|O1|Outcome|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
612940|NCT01009840|B1|Baseline|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
612941|NCT01009840|P1|Participant Flow|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the pharmacokinetic (PK)-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to hematopoietic stem cell transplant (HSCT).
612942|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
612943|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
612944|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
612945|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
612946|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
612947|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
612948|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
612949|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
612950|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
612951|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
613115|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613180|NCT01010750|E1|Reported Event|LDX 50 mg|
612952|NCT01009840|E1|Reported Event|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
612953|NCT01009931|B1|Baseline|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)
12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).
Up to 6 cycles.
Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.
Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.
Up to 6 cycles."
612954|NCT01009931|P1|Participant Flow|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)
12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).
Up to 6 cycles.
Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.
Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.
Up to 6 cycles."
612955|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)
12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).
Up to 6 cycles.
Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.
Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.
Up to 6 cycles."
612956|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)
12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).
Up to 6 cycles.
Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.
Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.
Up to 6 cycles."
612957|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)
12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).
Up to 6 cycles.
Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.
Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.
Up to 6 cycles."
613082|NCT01010282|E3|Reported Event|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
613083|NCT01010282|E2|Reported Event|Artificial Tears Formulation 2|Artificial Tears Formulation 2
612958|NCT01009931|E1|Reported Event|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)
12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).
Up to 6 cycles.
Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.
Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.
Up to 6 cycles."
612959|NCT01009983|B1|Baseline|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study"
612960|NCT01009983|P1|Participant Flow|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study"
612961|NCT01009983|O1|Outcome|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study"
612962|NCT01009983|E1|Reported Event|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study"
612963|NCT01010009|B4|Baseline|Total|Total of all reporting groups
612964|NCT01010009|B3|Baseline|Placebo Then Resveratrol 250mg Then Resveratrol 500mg|
612965|NCT01010009|B2|Baseline|Resveratrol 500mg Then Placebo Then Resveratrol 250mg|
612966|NCT01010009|B1|Baseline|Resveratrol 250mg Then Resveratrol 500mg Then Placebo|
612967|NCT01010009|P3|Participant Flow|Placebo Then Resveratrol 250mg Then Resveratrol 500mg|
612968|NCT01010009|P2|Participant Flow|Resveratrol 500mg Then Placebo Then Resveratrol 250mg|
612969|NCT01010009|P1|Participant Flow|Resveratrol 250mg Then Resveratrol 500mg Then Placebo|
612970|NCT01010009|O3|Outcome|Placebo|
612971|NCT01010009|O2|Outcome|Resveratrol 500mg|
612972|NCT01010009|O1|Outcome|Resveratrol 250mg|
612973|NCT01010009|O3|Outcome|Placebo|
612974|NCT01010009|O2|Outcome|Resveratrol 500mg|
612975|NCT01010009|O1|Outcome|Resveratrol 250mg|
612976|NCT01010009|O3|Outcome|Placebo|
612977|NCT01010009|O2|Outcome|Resveratrol 500mg|
612978|NCT01010009|O1|Outcome|Resveratrol 250mg|
612979|NCT01010009|E3|Reported Event|Placebo|
612980|NCT01010009|E2|Reported Event|Resveratrol 500mg|
612981|NCT01010009|E1|Reported Event|Resveratrol 250mg|
612982|NCT01010061|B3|Baseline|Total|Total of all reporting groups
612983|NCT01010061|B2|Baseline|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
613116|NCT01010503|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
612984|NCT01010061|B1|Baseline|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
612985|NCT01010061|P2|Participant Flow|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
612986|NCT01010061|P1|Participant Flow|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
612987|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
612988|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
612989|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
612990|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
612991|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
612992|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
612993|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
613084|NCT01010282|E1|Reported Event|Artificial Tears Formulation 1|Artificial Tears Formulation 1
612994|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
612995|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
612996|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
612997|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
612998|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
612999|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
613000|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
613001|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
613002|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
613003|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
613004|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
613117|NCT01010555|B1|Baseline|Overall|This reporting group includes all enrolled subjects.
613408|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere worn
613005|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
613006|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
613007|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
613008|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
613009|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
613010|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
613011|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
613012|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
613013|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
613014|NCT01010061|E2|Reported Event|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
613015|NCT01010061|E1|Reported Event|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
613017|NCT01010204|B2|Baseline|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
613018|NCT01010204|B1|Baseline|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
613019|NCT01010204|P2|Participant Flow|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
613020|NCT01010204|P1|Participant Flow|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
613021|NCT01010204|O2|Outcome|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
613168|NCT01010750|O1|Outcome|LDX 50 mg|
613169|NCT01010750|O3|Outcome|Placebo|
613022|NCT01010204|O1|Outcome|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
613023|NCT01010204|O2|Outcome|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
613024|NCT01010204|O1|Outcome|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
613025|NCT01010204|E2|Reported Event|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
613026|NCT01010204|E1|Reported Event|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
613027|NCT01010230|B3|Baseline|Total|Total of all reporting groups
613085|NCT01010399|B1|Baseline|Boosted Lexiva With Lovaza|
613086|NCT01010399|P1|Participant Flow|Boosted Lexiva With Lovaza|
613028|NCT01010230|B2|Baseline|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613029|NCT01010230|B1|Baseline|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613030|NCT01010230|P2|Participant Flow|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613031|NCT01010230|P1|Participant Flow|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613032|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613033|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613034|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613035|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613036|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613037|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613038|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613039|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613087|NCT01010399|O1|Outcome|Boosted Lexiva With Lovaza|
613088|NCT01010399|O1|Outcome|Boosted Lexiva With Lovaza|
613089|NCT01010399|E1|Reported Event|Boosted Lexiva With Lovaza|
613040|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613041|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613042|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613043|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613044|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613045|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613046|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613047|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613048|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613049|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613050|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613051|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613090|NCT01010477|B3|Baseline|Total|Total of all reporting groups
613091|NCT01010477|B2|Baseline|Placebo NS|Receives placebo (piperine containing) nasal spray
613092|NCT01010477|B1|Baseline|NNS Active|Receives nicotine (active) nasal spray
613052|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613053|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613054|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613055|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613056|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613057|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613058|NCT01010230|E2|Reported Event|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
613059|NCT01010230|E1|Reported Event|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform
LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
613060|NCT01010282|B4|Baseline|Total|Total of all reporting groups
613061|NCT01010282|B3|Baseline|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
613062|NCT01010282|B2|Baseline|Artificial Tears Formulation 2|Artificial Tears Formulation 2
613063|NCT01010282|B1|Baseline|Artificial Tears Formulation 1|Artificial Tears Formulation 1
613064|NCT01010282|P3|Participant Flow|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
613065|NCT01010282|P2|Participant Flow|Artificial Tears Formulation 2|Artificial Tears Formulation 2
613066|NCT01010282|P1|Participant Flow|Artificial Tears Formulation 1|Artificial Tears Formulation 1
613067|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
613068|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
613069|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
613070|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
613071|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
613072|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
613073|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
613074|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
613075|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
613076|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
613077|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
613078|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
613079|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
613080|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
627938|NCT01059760|O3|Outcome|Change When Fed|
613093|NCT01010477|P2|Participant Flow|Placebo|Receives placebo (piperine)nasal spray
613094|NCT01010477|P1|Participant Flow|NNS Active|Receives active nicotine containing Nasal spray
613095|NCT01010477|O2|Outcome|Placebo|Receives placebo (piperine)nasal spray
613096|NCT01010477|O1|Outcome|NNS Active|Receives nicotine (active ) nasal spray
613097|NCT01010477|E2|Reported Event|Placebo|Receives placebo (piperine)nasal spray
613098|NCT01010477|E1|Reported Event|NNS Active|Receives nicotine (active) nasal spray
613099|NCT01010503|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613100|NCT01010503|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613101|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613102|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613103|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613104|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613105|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613106|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613107|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613108|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613109|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613110|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613111|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613112|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613113|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613114|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
613118|NCT01010555|P2|Participant Flow|Senofilcon A/Enfilcon A, Then Lotrafilcon b/Balafilcon A|Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
613119|NCT01010555|P1|Participant Flow|Lotrafilcon B/Balafilcon A, Then Senofilcon A/Enfilcon A|Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
613120|NCT01010555|O4|Outcome|Enfilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
613121|NCT01010555|O3|Outcome|Senofilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
613122|NCT01010555|O2|Outcome|Balafilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
613123|NCT01010555|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
613124|NCT01010555|E4|Reported Event|Enfilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
613125|NCT01010555|E3|Reported Event|Senofilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
613126|NCT01010555|E2|Reported Event|Balafilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
613127|NCT01010555|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
613128|NCT01010568|B1|Baseline|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine
Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
613129|NCT01010568|P1|Participant Flow|Ofatumumab and Bendamustine|Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
613130|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine
Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
613131|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
613132|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine
Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
613133|NCT01010568|E1|Reported Event|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine
Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
613134|NCT01010633|B3|Baseline|Total|Total of all reporting groups
613135|NCT01010633|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate
613136|NCT01010633|B1|Baseline|Loteprednol|Loteprednol etabonate 0.5%
613137|NCT01010633|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate
613138|NCT01010633|P1|Participant Flow|Loteprednol|Loteprednol etabonate 0.5%
613139|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
613140|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
613141|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
613142|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
613143|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
613144|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
613145|NCT01010633|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate
613146|NCT01010633|E1|Reported Event|Loteprednol|Loteprednol etabonate 0.5%
613147|NCT01010750|B7|Baseline|Total|Total of all reporting groups
613148|NCT01010750|B6|Baseline|MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg|
613149|NCT01010750|B5|Baseline|MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo|
613150|NCT01010750|B4|Baseline|Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg|
613151|NCT01010750|B3|Baseline|Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg|
613152|NCT01010750|B2|Baseline|LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg|
613153|NCT01010750|B1|Baseline|LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo|
613154|NCT01010750|P6|Participant Flow|MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg|MAS-IR 20 mg + LDX placebo first, then LDX placebo + MAS-IR placebo, then LDX 50 mg + MAS-IR placebo
613155|NCT01010750|P5|Participant Flow|MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo|MAS-IR 20 mg + LDX placebo first, then LDX 50 mg + MAS-IR placebo, then LDX placebo + MAS-IR placebo
613156|NCT01010750|P4|Participant Flow|Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg|LDX placebo + MAS-IR placebo first, then MAS-IR 20 mg + LDX placebo, then LDX 50 mg + MAS-IR placebo
613157|NCT01010750|P3|Participant Flow|Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg|LDX placebo + MAS-IR placebo first, then LDX 50 mg + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
613158|NCT01010750|P2|Participant Flow|LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg|LDX 50 mg + MAS-IR placebo first, then LDX placebo + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
613159|NCT01010750|P1|Participant Flow|LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo|Lisdexamfetamine Dimesylate (LDX) 50 mg + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo first, then MAS-IR 20 mg + LDX placebo, then LDX placebo + MAS-IR placebo
613160|NCT01010750|O3|Outcome|Placebo|
613161|NCT01010750|O2|Outcome|MAS-IR 20 mg|
613162|NCT01010750|O1|Outcome|LDX 50 mg|
613163|NCT01010750|O3|Outcome|Placebo|
613164|NCT01010750|O2|Outcome|MAS-IR 20 mg|
613165|NCT01010750|O1|Outcome|LDX 50 mg|
613166|NCT01010750|O3|Outcome|Placebo|
613167|NCT01010750|O2|Outcome|MAS-IR 20 mg|
613181|NCT01010776|B1|Baseline|Paliperidone ER - Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613182|NCT01010776|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613183|NCT01010776|O1|Outcome|Paliperidone ER-Main Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613184|NCT01010776|O1|Outcome|Paliperidone ER - Main Phase|Single oral dose of paliperidone ER tablet within the range of 3 to 12 mg once a day was administered for 26 weeks. Dosage was adjusted as per the investigator’s discretion.
613185|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613186|NCT01010776|O1|Outcome|Paliperidone ER- Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
613187|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613447|NCT01016691|E2|Reported Event|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
613188|NCT01010776|O1|Outcome|Paliperidone ER - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
613189|NCT01010776|O1|Outcome|Paliperidone ER - Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally, once daily for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613190|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
613191|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613192|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
613193|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613194|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
613195|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613196|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
613197|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613198|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
613199|NCT01010776|O1|Outcome|Paliperidone (ER) - Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613200|NCT01010776|O1|Outcome|Paliperidone Extended Release (ER) - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
613201|NCT01010776|E2|Reported Event|Paliperidone ER - Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
613202|NCT01010776|E1|Reported Event|Paliperidone ER - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
613974|NCT01025336|B6|Baseline|Total|Total of all reporting groups
613203|NCT01010867|B1|Baseline|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.
Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
613204|NCT01010867|P1|Participant Flow|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.
Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C.
Colony forming units (CFU)"
613205|NCT01010867|O1|Outcome|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.
Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
613206|NCT01010867|O1|Outcome|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.
Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
613207|NCT01010867|O1|Outcome|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.
Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
613489|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613208|NCT01010867|O1|Outcome|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.
Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
613209|NCT01010867|E1|Reported Event|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.
Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
613210|NCT01016483|B5|Baseline|Total|Total of all reporting groups
613211|NCT01016483|B4|Baseline|Phase II: Arm 2 (Gemcitabine + Pimasertib)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
613212|NCT01016483|B3|Baseline|Phase II: Arm 1 (Gemcitabine + Placebo)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
613213|NCT01016483|B2|Baseline|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613214|NCT01016483|B1|Baseline|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613215|NCT01016483|P4|Participant Flow|Phase II: Arm 2 (Gemcitabine + Pimasertib)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
613216|NCT01016483|P3|Participant Flow|Phase II: Arm 1 (Gemcitabine + Placebo)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
613217|NCT01016483|P2|Participant Flow|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks) (bid continuous regimen).
613218|NCT01016483|P1|Participant Flow|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613219|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
613342|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613220|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
613221|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
613222|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
613223|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
613224|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
613225|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
613226|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
613227|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
614080|NCT01025830|O4|Outcome|Brand Nevirapine|Period when subjects were on brand nevirapine
613228|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
613229|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
613230|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
613231|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
613232|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
613233|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
613234|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
613235|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613236|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613237|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
613238|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
613239|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
613409|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal worn.
613240|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
613241|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
613242|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
613243|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613244|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613245|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613246|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613247|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613448|NCT01016691|E1|Reported Event|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
627939|NCT01059760|O2|Outcome|Change While Fasting|
613248|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613249|NCT01016483|O2|Outcome|Regimen 1: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613250|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613251|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613252|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613253|NCT01016483|O6|Outcome|Regimen1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613254|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613255|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613256|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613257|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613258|NCT01016483|O1|Outcome|Regimen 1:15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613259|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613410|NCT01016652|E2|Reported Event|Etafilcon A Sphere|etafilcon A sphere worn
613260|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613261|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613262|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613263|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613264|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613265|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613266|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613267|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613486|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613268|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613269|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613270|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613271|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613272|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613273|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613274|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613275|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613276|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613277|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613278|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613411|NCT01016652|E1|Reported Event|Etafilcon A Multifocal|etafilcon A multifocal worn
613279|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613280|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613281|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613282|NCT01016483|O1|Outcome|Regimen 1:15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613283|NCT01016483|O6|Outcome|Regimen1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613284|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613285|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613286|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613327|NCT01016600|B1|Baseline|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613287|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613288|NCT01016483|O1|Outcome|Regimen 1:15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613289|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613290|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613291|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613292|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613293|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613294|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613295|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 120 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
613296|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 90 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
613343|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
615765|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
613297|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 68 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
613298|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613299|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613300|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613301|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613302|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613303|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613304|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613305|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613487|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613306|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613307|NCT01016483|O2|Outcome|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613308|NCT01016483|O1|Outcome|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613309|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
613310|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
613311|NCT01016483|O8|Outcome|Safety Run-in Part Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613312|NCT01016483|O7|Outcome|Safety Run-in Part Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
613313|NCT01016483|O6|Outcome|Safety Run-in Part Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613314|NCT01016483|O5|Outcome|Safety Run-in Part Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613315|NCT01016483|O4|Outcome|Safety Run-in Part Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613405|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
613316|NCT01016483|O3|Outcome|Safety Run-in Part Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613317|NCT01016483|O2|Outcome|Safety Run-in Part Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613318|NCT01016483|O1|Outcome|Safety Run-in Part Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613319|NCT01016483|E4|Reported Event|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib orally 60 mg bid - continuous regimen.
613320|NCT01016483|E3|Reported Event|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib orally 60 mg bid - continuous regimen.
613321|NCT01016483|E2|Reported Event|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613322|NCT01016483|E1|Reported Event|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
613323|NCT01016600|B5|Baseline|Total|Total of all reporting groups
613324|NCT01016600|B4|Baseline|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613325|NCT01016600|B3|Baseline|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613326|NCT01016600|B2|Baseline|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613444|NCT01016691|O2|Outcome|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
613328|NCT01016600|P4|Participant Flow|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613329|NCT01016600|P3|Participant Flow|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613330|NCT01016600|P2|Participant Flow|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613331|NCT01016600|P1|Participant Flow|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613332|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613333|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613334|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613335|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613336|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613337|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613338|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613339|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613340|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613341|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613406|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
613407|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
613344|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613345|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613346|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613347|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613348|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613349|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613350|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613351|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613352|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613353|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613354|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613355|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613356|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
627940|NCT01059760|O1|Outcome|Baseline Value|
613357|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613358|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613359|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613360|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613361|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613362|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613363|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613364|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613365|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613366|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613367|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613368|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613369|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613370|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613371|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613372|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613373|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613374|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613375|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613376|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613377|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613378|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613379|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613380|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613381|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613382|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613383|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613384|NCT01016600|O1|Outcome|Phase I Cohort|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613385|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613488|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613386|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613387|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613388|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613389|NCT01016600|E4|Reported Event|Phase II|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613390|NCT01016600|E3|Reported Event|Cohort 3|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613391|NCT01016600|E2|Reported Event|Cohort 2|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613392|NCT01016600|E1|Reported Event|Cohort 1|"Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5"
613393|NCT01016652|B3|Baseline|Total|Total of all reporting groups
613394|NCT01016652|B2|Baseline|Etafilcon A Sphere\ Etafilcon A Multifocal|"etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.
Repeat for the second lens (multifocal)."
613395|NCT01016652|B1|Baseline|Etafilcon A Multifocal/ Etafilcon A Sphere|etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
613396|NCT01016652|P2|Participant Flow|Etafilcon A Sphere/ Etafilcon A Multifocal|"etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.
Repeat for the second lens (multifocal)."
613397|NCT01016652|P1|Participant Flow|Etafilcon A Multifocal/ Etafilcon A Sphere|etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
613398|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
613399|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
613400|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
613401|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
613402|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
613403|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
613404|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
613412|NCT01016678|B1|Baseline|Adolescents Age 12-17|All subjects were adolescent males and females with diagnosis of Migraine and a frequency of 1-8 migraines per month on average
613413|NCT01016678|P5|Participant Flow|Active, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
All migraines (up to four) will be treated with active treximet"
613414|NCT01016678|P4|Participant Flow|Placebo, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet"
613415|NCT01016678|P3|Participant Flow|Active, Placebo, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet"
613416|NCT01016678|P2|Participant Flow|Active, Active, Placebo, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet"
613417|NCT01016678|P1|Participant Flow|Active, Active, Active, Placebo|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo"
613418|NCT01016678|O5|Outcome|Active, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
All migraines (up to four) will be treated with active treximet"
613445|NCT01016691|O1|Outcome|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
613446|NCT01016691|E3|Reported Event|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
613419|NCT01016678|O4|Outcome|Placebo, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet"
613420|NCT01016678|O3|Outcome|Active, Placebo, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet"
613421|NCT01016678|O2|Outcome|Active, Active, Placebo, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet"
613422|NCT01016678|O1|Outcome|Active, Active, Active, Placebo|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo"
613423|NCT01016678|O2|Outcome|Placebo|"Equivalent looking pill just like Treximet but only containing sugar, sugar pill."
613424|NCT01016678|O1|Outcome|Active Drug|Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.
613425|NCT01016678|O2|Outcome|Placebo|"Equivalent looking pill just like Treximet but only containing sugar, sugar pill."
613426|NCT01016678|O1|Outcome|Active Drug|Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.
613427|NCT01016678|O4|Outcome|Migraine Attack 4|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
613428|NCT01016678|O3|Outcome|Migraine Attack 3|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
613429|NCT01016678|O2|Outcome|Migraine Attack 2|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
613466|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
613467|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day"
614327|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
613430|NCT01016678|O1|Outcome|Migraine Attack 1|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
613431|NCT01016678|E5|Reported Event|Active, Active, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
613432|NCT01016678|E4|Reported Event|Placebo, Active, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
613433|NCT01016678|E3|Reported Event|Active, Placebo, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
613434|NCT01016678|E2|Reported Event|Active, Active, Placebo, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
613435|NCT01016678|E1|Reported Event|Active, Active, Active, Placebo|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
613436|NCT01016691|B4|Baseline|Total|Total of all reporting groups
613437|NCT01016691|B3|Baseline|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
613438|NCT01016691|B2|Baseline|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
613439|NCT01016691|B1|Baseline|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
613440|NCT01016691|P3|Participant Flow|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
613441|NCT01016691|P2|Participant Flow|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
613442|NCT01016691|P1|Participant Flow|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
613443|NCT01016691|O3|Outcome|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
613449|NCT01016834|B1|Baseline|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
613450|NCT01016834|P1|Participant Flow|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
613451|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
613452|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
613453|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
613454|NCT01016834|E1|Reported Event|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
613455|NCT01016847|B3|Baseline|Total|Total of all reporting groups
613456|NCT01016847|B2|Baseline|Sugar Pill|"High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
613457|NCT01016847|B1|Baseline|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day"
613458|NCT01016847|P2|Participant Flow|Sugar Pill|"High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
613459|NCT01016847|P1|Participant Flow|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day"
613460|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
613461|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day"
613462|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
613463|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day"
613464|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
613465|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day"
613468|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
613469|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day"
613470|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
613471|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day"
613472|NCT01016847|E2|Reported Event|Sugar Pill|"High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
613473|NCT01016847|E1|Reported Event|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day"
613474|NCT01016873|B4|Baseline|Total|Total of all reporting groups
613475|NCT01016873|B3|Baseline|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613476|NCT01016873|B2|Baseline|24 Gy IRay|"24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613477|NCT01016873|B1|Baseline|16 Gy IRay|"16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613478|NCT01016873|P3|Participant Flow|Sham IRay|"Sham 24 or 16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613479|NCT01016873|P2|Participant Flow|24 Gy IRay|"24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613480|NCT01016873|P1|Participant Flow|16 Gy IRay|"16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613481|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613482|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613483|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613484|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613485|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
614081|NCT01025830|O3|Outcome|Generic Nevirapine|period when subjects were on generic nevirapine
613490|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613491|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613492|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613493|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613494|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613495|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613496|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613497|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613498|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613499|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613500|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613501|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613502|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613503|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613504|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613505|NCT01016873|E3|Reported Event|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613506|NCT01016873|E2|Reported Event|24 Gy IRay|"24 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613507|NCT01016873|E1|Reported Event|16 Gy IRay|"16 Gy IRay + PRN Lucentis®
IRay: Low voltage stereotactic radiotherapy system"
613508|NCT01016912|B6|Baseline|Total|Total of all reporting groups
613509|NCT01016912|B5|Baseline|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
613510|NCT01016912|B4|Baseline|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
613511|NCT01016912|B3|Baseline|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613512|NCT01016912|B2|Baseline|Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613513|NCT01016912|B1|Baseline|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613514|NCT01016912|P5|Participant Flow|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
613515|NCT01016912|P4|Participant Flow|Daclatasvir 10­ mg + pegIFNα+ Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
613516|NCT01016912|P3|Participant Flow|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613517|NCT01016912|P2|Participant Flow|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613518|NCT01016912|P1|Participant Flow|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613519|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
613520|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
627941|NCT01059760|O3|Outcome|Change When Fed|
613521|NCT01016912|O3|Outcome|Daclatasvir 60 mg + Peg-IFNα + Ribavirin (Treatment-naive)|received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613522|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
613523|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
613524|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin
613525|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
613526|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613527|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613528|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613529|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
613530|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonreponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
613531|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613585|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
614328|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
613532|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613533|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613534|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
613535|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin..
613536|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613537|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613538|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
613539|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
613540|NCT01016912|O4|Outcome|Daclatasvir 10­ mg + pegINFα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
613541|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment Naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613542|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
613543|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613544|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
613545|NCT01016912|O4|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
613546|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613547|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
613548|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
613549|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
613550|NCT01016912|O4|Outcome|Daclatasvir 10­ mg+ pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
613551|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
613552|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613553|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
613554|NCT01016912|E5|Reported Event|Daclatasvir 60­ mg+pegIFNα+Ribavirin (Non-­Responders)|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
613555|NCT01016912|E4|Reported Event|Daclatasvir 10­ mg+pegIFNα+Ribavirin (Non-­Responders)|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
613556|NCT01016912|E3|Reported Event|Daclatasvir 60­ mg+pegIFNα+Ribavirin (Treatment Naive)|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
613557|NCT01016912|E2|Reported Event|Daclatasvir 10­ mg+pegIFNα+Ribavirin (Treatment Naive)|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
613600|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
614048|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
613558|NCT01016912|E1|Reported Event|Placebo+pegIFNα +Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon IFNα containing regimens including pegIFNα-2b/ribavirin.
613559|NCT01016938|B1|Baseline|Dynmaic Lung MRI|Lung Tumor Motion and Function
613560|NCT01016938|P1|Participant Flow|Dynamic Lung MRI|Lung Tumor Motion and Function
613561|NCT01016938|O1|Outcome|Dynamic Lung MRI|Lung Tumor Motion and Function
613562|NCT01016938|O1|Outcome|Lung Tumor Motion and Lung Function|This is a pilot study and there is only one group.
613563|NCT01016938|E1|Reported Event|Dynamic Lung MRI|Lung Tumor Motion and Function
613564|NCT01016964|B3|Baseline|Total|Total of all reporting groups
613565|NCT01016964|B2|Baseline|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
613566|NCT01016964|B1|Baseline|Sham Device|Sham device
613567|NCT01016964|P2|Participant Flow|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
613568|NCT01016964|P1|Participant Flow|Sham Device|Sham device
613569|NCT01016964|O2|Outcome|LLT Device 2009 12 Beams|This is the active LLLT device
613570|NCT01016964|O1|Outcome|Sham Device|This control device emits white light
613571|NCT01016964|E2|Reported Event|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
613572|NCT01016964|E1|Reported Event|Sham Device|Sham device
613573|NCT01016977|B3|Baseline|Total|Total of all reporting groups
613574|NCT01016977|B2|Baseline|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613575|NCT01016977|B1|Baseline|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
613576|NCT01016977|P2|Participant Flow|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613577|NCT01016977|P1|Participant Flow|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
613578|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613579|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613580|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613581|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613582|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613583|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613584|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613586|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613587|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613588|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613589|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613590|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613591|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613592|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613593|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613594|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613595|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613596|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613597|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613598|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613599|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613601|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613602|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613603|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613604|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613605|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
613606|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613607|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
613608|NCT01016977|E2|Reported Event|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
613609|NCT01016977|E1|Reported Event|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
613610|NCT01017003|B1|Baseline|Colchicine - Single Dose, Twice Daily Dose, Final Single Dose|All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
613611|NCT01017003|P1|Participant Flow|Colchicine - Single Dose, Twice Daily Dose, Final Single Dose|All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
613612|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
613613|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
613614|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
613615|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
613616|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
613617|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
613618|NCT01017003|E2|Reported Event|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
613619|NCT01017003|E1|Reported Event|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
613620|NCT01017029|B3|Baseline|Total|Total of all reporting groups
613701|NCT01017146|B3|Baseline|Total|Total of all reporting groups
613621|NCT01017029|B2|Baseline|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
613622|NCT01017029|B1|Baseline|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
613623|NCT01017029|P2|Participant Flow|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
613624|NCT01017029|P1|Participant Flow|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
613625|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
613626|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
613627|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
613628|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
613629|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
613630|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
613631|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
613632|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
614082|NCT01025830|O2|Outcome|Brand Stavudine|period when subjects were on brand stavudine
613633|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
613634|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
613635|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
613636|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
613637|NCT01017029|E2|Reported Event|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
613638|NCT01017029|E1|Reported Event|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
613639|NCT01017042|B1|Baseline|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
613640|NCT01017042|P1|Participant Flow|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
613641|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
613642|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
613643|NCT01017042|O5|Outcome|Corrected QTc Interval (4 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (4 hour)
613644|NCT01017042|O4|Outcome|Corrected QTc Interval (2 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (2 hour)
613645|NCT01017042|O3|Outcome|Corrected QTc Interval (1 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (1 hour)
613646|NCT01017042|O2|Outcome|Corrected QTc Interval (0.5 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (0.5hour)
613647|NCT01017042|O1|Outcome|Corrected QTc Interval (Baseline)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (Baseline)
613648|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
615766|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
613649|NCT01017042|E1|Reported Event|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
613650|NCT01017120|B3|Baseline|Total|Total of all reporting groups
613651|NCT01017120|B2|Baseline|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613652|NCT01017120|B1|Baseline|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613653|NCT01017120|P2|Participant Flow|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613654|NCT01017120|P1|Participant Flow|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613655|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613673|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613656|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613657|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613658|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613659|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613660|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613661|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613662|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613663|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613664|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613665|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613837|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613666|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613667|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613668|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613669|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613670|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613671|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613672|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613812|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613674|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613675|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613676|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613677|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613678|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613679|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613680|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613681|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613682|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613683|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613684|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613685|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613686|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613687|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613688|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613689|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613690|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613813|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613691|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613692|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613693|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613694|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613695|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613696|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613697|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613698|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613699|NCT01017120|E2|Reported Event|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613700|NCT01017120|E1|Reported Event|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613702|NCT01017146|B2|Baseline|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613703|NCT01017146|B1|Baseline|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613704|NCT01017146|P2|Participant Flow|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613705|NCT01017146|P1|Participant Flow|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613706|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613707|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613708|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
614083|NCT01025830|O1|Outcome|Generic Stavudine|period when subjects were on generic stavudine
613709|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613710|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613711|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613712|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613713|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613714|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613715|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613716|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613717|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613718|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
614329|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
613719|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613720|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613721|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613722|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613723|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613724|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613725|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613814|NCT01017250|E1|Reported Event|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613726|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613727|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613728|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613729|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613730|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613731|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613732|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613733|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613734|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613735|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613736|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613737|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613738|NCT01017146|E2|Reported Event|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613739|NCT01017146|E1|Reported Event|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
613740|NCT01017237|B3|Baseline|Total|Total of all reporting groups
613741|NCT01017237|B2|Baseline|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613742|NCT01017237|B1|Baseline|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613815|NCT01017263|B1|Baseline|Open Label Vyvanse|All subjects receive Vyvanse.
614049|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
613743|NCT01017237|P2|Participant Flow|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613744|NCT01017237|P1|Participant Flow|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613745|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613746|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
613747|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613748|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
613749|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613750|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613794|NCT01017237|E1|Reported Event|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613751|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613752|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613753|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613754|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
613755|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613756|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
613757|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613758|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
613929|NCT01025076|B1|Baseline|StomaphX|Patients with weight gain following VBG had endoluminal pouch reduction performed using the StomaphyXTM device in revisional bariatric surgery clinic
613759|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613760|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
613761|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613762|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
613763|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613764|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
613765|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613766|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613795|NCT01017250|B1|Baseline|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613767|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613768|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613769|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613770|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613771|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613772|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613787|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613773|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613774|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613775|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613776|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613777|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613778|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
614330|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
613779|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613780|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613781|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613782|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613783|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613784|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
613785|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613786|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
613811|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613788|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613789|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613790|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613791|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
613792|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
613793|NCT01017237|E2|Reported Event|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.
Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
615767|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
613796|NCT01017250|P1|Participant Flow|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613797|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613798|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613799|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613800|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613801|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613802|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613803|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613804|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
613805|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613806|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613807|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613808|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613809|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613810|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
SRS is"
613930|NCT01025076|P1|Participant Flow|StomaphX|
613816|NCT01017263|P1|Participant Flow|Open Label Vyvanse|Eligible subjects will be dispensed open label LDX (Vyvanse). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
613817|NCT01017263|O1|Outcome|Vyvanse Open Label|Eligible subjects were dispensed open label LDX (VyvanseTM). All subjects started at 20 mg once a day dose and were titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level was allowed.
613818|NCT01017263|E1|Reported Event|Open Label Vyvanse|Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
613819|NCT01024036|B3|Baseline|Total|Total of all reporting groups
613820|NCT01024036|B2|Baseline|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613821|NCT01024036|B1|Baseline|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613822|NCT01024036|P2|Participant Flow|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613823|NCT01024036|P1|Participant Flow|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613824|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613825|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613826|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613827|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613828|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613829|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613830|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613831|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613832|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613833|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613834|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613835|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613836|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613838|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613839|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613840|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613841|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613842|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613843|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613844|NCT01024036|O1|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613845|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613846|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613847|NCT01024036|E3|Reported Event|Siltuximab + BSC (Unblinded)|Open label 11 mg/kg Siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613848|NCT01024036|E2|Reported Event|Placebo + Best Supportive Care (BSC) (Blinded)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
613849|NCT01024036|E1|Reported Event|Siltuximab + Best Supportive Care (BSC) (Blinded)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
613850|NCT01024608|B3|Baseline|Total|Total of all reporting groups
613851|NCT01024608|B2|Baseline|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
613852|NCT01024608|B1|Baseline|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
613853|NCT01024608|P2|Participant Flow|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
613854|NCT01024608|P1|Participant Flow|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
613855|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
613856|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
613857|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
613858|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
613859|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
613860|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
613861|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
613862|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
613863|NCT01024608|E2|Reported Event|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
613864|NCT01024608|E1|Reported Event|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
613865|NCT01024738|B4|Baseline|Total|Total of all reporting groups
613866|NCT01024738|B3|Baseline|Chlorhexidine Oral Rinse|chlorhexidine oral rinse (positive control)
613867|NCT01024738|B2|Baseline|Total Toothpaste|triclosan/fluoride toothpaste (positive control)
613868|NCT01024738|B1|Baseline|Fluoride Toothpaste|negative control toothpaste
613869|NCT01024738|P3|Participant Flow|Chlorhexidine Oral Rinse|chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
613870|NCT01024738|P2|Participant Flow|Triclosan/Fluoride Toothpaste First|triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
613871|NCT01024738|P1|Participant Flow|Fluoride Toothpaste First|Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
613872|NCT01024738|O3|Outcome|Chlorhexidine Oral Rinse|chlorhexidine oral rinse (positive control)
613873|NCT01024738|O2|Outcome|Total Toothpaste|triclosan/fluoride toothpaste (positive control)
613874|NCT01024738|O1|Outcome|Fluoride Toothpaste|negative control toothpaste
613875|NCT01024738|E3|Reported Event|Chlorhexidine Oral Rinse|chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
613876|NCT01024738|E2|Reported Event|Triclosan/Fluoride Toothpaste First|triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
613877|NCT01024738|E1|Reported Event|Fluoride Toothpaste First|Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
613878|NCT01024751|B3|Baseline|Total|Total of all reporting groups
613879|NCT01024751|B2|Baseline|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
613880|NCT01024751|B1|Baseline|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
613881|NCT01024751|P2|Participant Flow|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
613882|NCT01024751|P1|Participant Flow|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
613883|NCT01024751|O2|Outcome|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
613884|NCT01024751|O1|Outcome|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
613885|NCT01024751|O2|Outcome|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
613886|NCT01024751|O1|Outcome|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
613887|NCT01024751|E2|Reported Event|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
613888|NCT01024751|E1|Reported Event|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
613889|NCT01024855|B1|Baseline|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
613890|NCT01024855|P1|Participant Flow|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
613891|NCT01024855|O2|Outcome|OptiFree|30 subjects, one eye received Opti-Free RepleniSH MPS(control).
613892|NCT01024855|O1|Outcome|RevitaLens|30 subjects, one eye received RevitaLens MPS (investigational).
613893|NCT01024855|E1|Reported Event|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
613894|NCT01024946|B1|Baseline|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.
everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
613931|NCT01025076|O1|Outcome|StomaphX|
613932|NCT01025076|E1|Reported Event|StomaphX|
614084|NCT01025830|O6|Outcome|Brand Lamivudine|Period when subjects were on brand lamivudine
613895|NCT01024946|P1|Participant Flow|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.
everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
613896|NCT01024946|O1|Outcome|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.
everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
613897|NCT01024946|E1|Reported Event|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.
everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
613898|NCT01024959|B1|Baseline|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.
613899|NCT01024959|P1|Participant Flow|Prostate Cancer Gene 3 (PCA3) Assay|PCA3 Assay : Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.
613900|NCT01024959|O3|Outcome|Subjects With Negative Biopsy Result|Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)
613901|NCT01024959|O2|Outcome|Subjects With Positive Biopsy Result|Presence of prostate cancer defined by one or more positive biopsy cores
613902|NCT01024959|O1|Outcome|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy
613903|NCT01024959|E4|Reported Event|Subjects With no Biopsy Performed|
615768|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
613904|NCT01024959|E3|Reported Event|Subjects With Negative Biopsy Result|Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)
613905|NCT01024959|E2|Reported Event|Subjects With Positive Biopsy Result|Presence of prostate cancer defined by one or more positive biopsy cores
613906|NCT01024959|E1|Reported Event|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy
613907|NCT01024972|B3|Baseline|Total|Total of all reporting groups
613908|NCT01024972|B2|Baseline|Placebo|Equiosmolar volume (5% mannitol) every 6 hours for seven days.
613909|NCT01024972|B1|Baseline|Dantrolene|Intravenous Datrolene 1.25 mg/kg (includes 5% mannitol) every 6 hours for seven days.
613910|NCT01024972|P2|Participant Flow|Placebo|"Equiosmolar volume (5% Mannitol)
Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days"
613911|NCT01024972|P1|Participant Flow|Dantrolene|"Dantrolene 1.25mg/kg IV every 6 hours x 7 days
Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days"
613912|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
613913|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
613914|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
613915|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
613916|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days.
613917|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
613918|NCT01024972|E2|Reported Event|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
613919|NCT01024972|E1|Reported Event|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
613920|NCT01025037|B1|Baseline|Conexa|Rotator cuff repair using Conexa
613921|NCT01025037|P1|Participant Flow|Conexa|Rotator cuff repair using Conexa
613922|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
613923|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
613924|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
613925|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
613926|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
613927|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
613928|NCT01025037|E1|Reported Event|Conexa|Rotator cuff repair using Conexa
613933|NCT01025154|B1|Baseline|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
613934|NCT01025154|P1|Participant Flow|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
613935|NCT01025154|O1|Outcome|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
613936|NCT01025154|O1|Outcome|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
613937|NCT01025154|E1|Reported Event|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
613938|NCT01025193|B1|Baseline|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used in to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).
Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
613939|NCT01025193|P1|Participant Flow|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was being used to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use was considered investigational (not approved by the Food and Drug Administration).
Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
613940|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).
Belimumab : The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
613951|NCT01025232|P2|Participant Flow|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
614406|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
613941|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used in to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).
Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
613942|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).
Belimumab: The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
613943|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).
Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
613944|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).
Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
613960|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
614050|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
627942|NCT01059760|O2|Outcome|Change While Fasting|
613945|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).
Belimumab : The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
613946|NCT01025193|O1|Outcome|Belimumab|"Belimumab will be administered intravenously at a dose of 10mg/kg on days 0, 14, 28 and every 28 days for up to 52 weeks to normalize alloantibody levels in sensitized patients awaiting kidney transplantation. Subjects who are not able to undergo transplantation before the end of the treatment period will have final follow-up evaluation 8 weeks after the last dose of belimumab is administered.
Belimumab: Belimumab is a fully human monoclonal antibody that recognizes and inhibits BLyS ®. BLyS ® is a B-lymphocyte stimulator protein which plays a role in the development of B lymphocyte cells into plasma B cells, which then produce antibodies that can sensitize a potential transplant recipient. At the time of this trial, belimumab was not yet FDA approved and was being studied in clinical trials for the treatment of systemic lupus erythematosus. Until this trial, it had not yet been used in the transplant setting."
613947|NCT01025193|E1|Reported Event|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the patient waiting for kidney transplant's blood. This use was considered investigational (not approved by the Food and Drug Administration).
Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
613948|NCT01025232|B3|Baseline|Total|Total of all reporting groups
613949|NCT01025232|B2|Baseline|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613950|NCT01025232|B1|Baseline|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613973|NCT01025271|E1|Reported Event|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
613952|NCT01025232|P1|Participant Flow|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613953|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613954|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613955|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613956|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613957|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613958|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613959|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
614047|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
627943|NCT01059760|O1|Outcome|Baseline Value|
613961|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613962|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613963|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613964|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613965|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613966|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613967|NCT01025232|E2|Reported Event|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613968|NCT01025232|E1|Reported Event|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.
Ranibizumab: Intravitreal Injection of 2.0mg formulation"
613969|NCT01025271|B1|Baseline|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
613970|NCT01025271|P1|Participant Flow|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
613971|NCT01025271|O1|Outcome|PK Sampling|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
613972|NCT01025271|O1|Outcome|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
613975|NCT01025336|B5|Baseline|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
613976|NCT01025336|B4|Baseline|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
613977|NCT01025336|B3|Baseline|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
613978|NCT01025336|B2|Baseline|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
613979|NCT01025336|B1|Baseline|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
613980|NCT01025336|P5|Participant Flow|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
613981|NCT01025336|P4|Participant Flow|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
613982|NCT01025336|P3|Participant Flow|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
613983|NCT01025336|P2|Participant Flow|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
613984|NCT01025336|P1|Participant Flow|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
613985|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
613986|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
613987|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
613988|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
613989|NCT01025336|O2|Outcome|23vPS (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (6115A1-3010 NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
613990|NCT01025336|O1|Outcome|13vPnC (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
613991|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
613992|NCT01025336|O2|Outcome|13vPnC (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
613993|NCT01025336|O1|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
613994|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
613995|NCT01025336|O2|Outcome|13vPnC (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and either 13vPnC or 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) (both 13vPnC/13vPnC and 13vPnC/23vPS dose groups)
613996|NCT01025336|O1|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
613997|NCT01025336|O2|Outcome|23vPS (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2).
613998|NCT01025336|O1|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
613999|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614000|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614001|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
627944|NCT01059760|O3|Outcome|Change When Fed|
614002|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614003|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614004|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614005|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614006|NCT01025336|O1|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614007|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614008|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614009|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614010|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614011|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614012|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614013|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614014|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614015|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614016|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614017|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614018|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614019|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614020|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614079|NCT01025830|O5|Outcome|Generic Lamivudine|period when subjects were on generic lamivudine
614021|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614022|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614023|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)and at Year 1 (Vaccination 2)
614024|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614025|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614026|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614027|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614028|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614029|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPs Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614030|NCT01025336|E5|Reported Event|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614102|NCT01025843|B2|Baseline|1 mg → 5 mg → 12 mg → Candesartan → Pbo|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
614031|NCT01025336|E4|Reported Event|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614032|NCT01025336|E3|Reported Event|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614033|NCT01025336|E2|Reported Event|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
614034|NCT01025336|E1|Reported Event|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
614035|NCT01025492|B1|Baseline|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
614036|NCT01025492|P1|Participant Flow|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
614037|NCT01025492|O1|Outcome|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
614038|NCT01025492|E1|Reported Event|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
614039|NCT01025635|B3|Baseline|Total|Total of all reporting groups
614040|NCT01025635|B2|Baseline|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
614041|NCT01025635|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
614042|NCT01025635|P2|Participant Flow|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
614043|NCT01025635|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
614044|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
614045|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
614046|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
614051|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
614052|NCT01025635|E2|Reported Event|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
614053|NCT01025635|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
614054|NCT01025817|B3|Baseline|Total|Total of all reporting groups
614055|NCT01025817|B2|Baseline|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
614056|NCT01025817|B1|Baseline|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
614057|NCT01025817|P2|Participant Flow|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
614058|NCT01025817|P1|Participant Flow|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
614059|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
614060|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
614061|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
614062|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
614063|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
614064|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
627945|NCT01059760|O2|Outcome|Change While Fasting|
614065|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
614066|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
614067|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
614068|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
614069|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
614103|NCT01025843|B1|Baseline|Pbo → 5 mg → Candesartan → 24 mg → 38 mg|Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
614104|NCT01025843|P10|Participant Flow|Candesartan → Pbo → 12 mg → 24 mg → 38 mg|Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
614070|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
614071|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
614072|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
614073|NCT01025817|E2|Reported Event|Mycophenolate Mofetil and Standard Dose Tacrolimus|The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
614074|NCT01025817|E1|Reported Event|Everolimus and Low Dose Tacrolimus|Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
614075|NCT01025830|B1|Baseline|Entire Study Population|Includes groups randomized to receive generic formulation and brand formulation
614076|NCT01025830|P2|Participant Flow|Brand (Zerit/Epivir/Viramune) to Generic (Triomune)|started with brand formulation(Zerit/Epivir/Viramune) then switched to generic formulation (Triomune)
614077|NCT01025830|P1|Participant Flow|Generic (Triomune) to Brand (Zerit/Epivir/Viramune)|Started with generic formulation (Triomune) then switched to brand formulation (Zerit/Epivir/Viramune).
614078|NCT01025830|O6|Outcome|Brand Lamivudine|Period when subjects were on brand lamivudine
614085|NCT01025830|O5|Outcome|Generic Lamivudine|period when subjects were on generic lamivudine
614086|NCT01025830|O4|Outcome|Brand Nevirapine|Period when subjects were on brand nevirapine
614087|NCT01025830|O3|Outcome|Generic Nevirapine|period when subjects were on generic nevirapine
614088|NCT01025830|O2|Outcome|Brand Stavudine|period when subjects were on brand stavudine
614089|NCT01025830|O1|Outcome|Generic Stavudine|period when subjects were on generic stavudine
614090|NCT01025830|E3|Reported Event|Brand to Generic|started with brand formulation then switched to generic formulation
614091|NCT01025830|E2|Reported Event|Generic to Brand|Started with generic formulation then switched to brand formulation
614092|NCT01025830|E1|Reported Event|Entire Study Population|Includes groups randomized to receive generic formulation and brand formulation
614093|NCT01025843|B11|Baseline|Total|Total of all reporting groups
614094|NCT01025843|B10|Baseline|Candesartan → Pbo → 12 mg → 24 mg → 38 mg|Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
614095|NCT01025843|B9|Baseline|Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg|Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
614096|NCT01025843|B8|Baseline|2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo|2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
614097|NCT01025843|B7|Baseline|2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg|2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
614098|NCT01025843|B6|Baseline|2 mg→Pbo → Candesartan → Pbo Fed → 38 mg|2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
614099|NCT01025843|B5|Baseline|Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan|Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
614100|NCT01025843|B4|Baseline|1 mg → 5 mg → 12 mg → Pbo → Candesartan|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
614101|NCT01025843|B3|Baseline|1 mg → Candesartan → Pbo → 24 mg → 38 mg|1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
614105|NCT01025843|P9|Participant Flow|Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg|Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
614106|NCT01025843|P8|Participant Flow|2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo|2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
614107|NCT01025843|P7|Participant Flow|2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg|2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
614108|NCT01025843|P6|Participant Flow|2 mg→Pbo → Candesartan → Pbo Fed → 38 mg|2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
614109|NCT01025843|P5|Participant Flow|Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan|Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
614110|NCT01025843|P4|Participant Flow|1 mg → 5 mg → 12 mg → Pbo → Candesartan|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
614111|NCT01025843|P3|Participant Flow|1 mg → Candesartan → Pbo → 24 mg → 38 mg|1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
614112|NCT01025843|P2|Participant Flow|1 mg → 5 mg → 12 mg → Candesartan → Pbo|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
614113|NCT01025843|P1|Participant Flow|Pbo → 5 mg → Candesartan → 24 mg → 38 mg|Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
614114|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
614115|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
614116|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
614117|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
614118|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
614119|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
614120|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
614121|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
614122|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
614123|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
614124|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
614125|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
614126|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
614127|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
614128|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
614129|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
614130|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
614131|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
614132|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
614133|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
614134|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
614135|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
614136|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
614137|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
614138|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
614139|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
614140|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
614141|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
614142|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
618930|NCT01037218|O4|Outcome|Placebo|Placebo tablets
614143|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
614144|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
614145|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
614146|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
614147|NCT01025843|O13|Outcome|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
614148|NCT01025843|O12|Outcome|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
614149|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
614150|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
614151|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
614152|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
614153|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
614154|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
614155|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
614156|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
614157|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
614158|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
614159|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
614160|NCT01025843|O13|Outcome|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
614161|NCT01025843|O12|Outcome|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
614162|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
614359|NCT01026402|P9|Participant Flow|Part A 175mg QD Tab Cont|Continuous QD dosing
614163|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
614164|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
614165|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
614166|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
614167|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
614168|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
614169|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
614170|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
614171|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
614172|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
614173|NCT01025843|E13|Reported Event|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
614174|NCT01025843|E12|Reported Event|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
614175|NCT01025843|E11|Reported Event|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
614176|NCT01025843|E10|Reported Event|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
614177|NCT01025843|E9|Reported Event|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
614178|NCT01025843|E8|Reported Event|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
614179|NCT01025843|E7|Reported Event|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
614180|NCT01025843|E6|Reported Event|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
614181|NCT01025843|E5|Reported Event|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
614182|NCT01025843|E4|Reported Event|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
614183|NCT01025843|E3|Reported Event|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
614184|NCT01025843|E2|Reported Event|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
614185|NCT01025843|E1|Reported Event|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
614186|NCT01026012|B1|Baseline|Combined Stress Group|patient's were monitor for approximately 30 minutes following regadenoson infusion
614324|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
614187|NCT01026012|P1|Participant Flow|Combined Stress Group|Subjects had a sub-maximal symptom limited stress test (<85% MPHR)then immediately followed by pharmological stress test with the infusion of regadenoson 400mcg infused over 10-20 seconds.
614188|NCT01026012|O1|Outcome|Combined Stress Group|Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.
614189|NCT01026012|E1|Reported Event|Safety|patient's were monitor for approximately 30 minutes following regadenoson infusion
614190|NCT01026038|B4|Baseline|Total|Total of all reporting groups
614191|NCT01026038|B3|Baseline|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614192|NCT01026038|B2|Baseline|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614193|NCT01026038|B1|Baseline|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614194|NCT01026038|P3|Participant Flow|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614195|NCT01026038|P2|Participant Flow|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614196|NCT01026038|P1|Participant Flow|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614197|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614198|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614199|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614200|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614201|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614202|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614203|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614204|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614205|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614206|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614207|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614208|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614209|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614210|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614211|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614212|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614213|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614214|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614215|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614216|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614217|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614218|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614219|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614220|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614221|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614222|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614223|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614224|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614225|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614226|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614227|NCT01026038|E3|Reported Event|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
614228|NCT01026038|E2|Reported Event|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
614229|NCT01026038|E1|Reported Event|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
614230|NCT01026103|B1|Baseline|Tri Staple|"This is a single arm study.
Tri Staple Technology stapler : This is a single arm study."
614231|NCT01026103|P1|Participant Flow|Tri Staple|"This is a single arm study.
Tri Staple Technology stapler : This is a single arm study."
614232|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.
Tri Staple Technology stapler : This is a single arm study."
614233|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.
Tri Staple Technology stapler : This is a single arm study."
614234|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.
Tri Staple Technology stapler : This is a single arm study."
614235|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.
Tri Staple Technology stapler : This is a single arm study."
614236|NCT01026103|E1|Reported Event|Tri Staple|This is a single arm study.
614237|NCT01026142|B3|Baseline|Total|Total of all reporting groups
627946|NCT01059760|O1|Outcome|Baseline Value|
614238|NCT01026142|B2|Baseline|Capecitabine + Trastuzumab + Pertuzumab|"capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks
pertuzumab: 840 mg iv loading, then 420 mg iv every 3 weeks
trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
614239|NCT01026142|B1|Baseline|Capecitabine + Trastuzumab|"capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks
trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
614240|NCT01026142|P2|Participant Flow|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
614241|NCT01026142|P1|Participant Flow|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
614242|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
614243|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
614244|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
614245|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
614246|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
614247|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
614248|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
614249|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
614250|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
614325|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
614251|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
614252|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
614253|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
614254|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
614255|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
614256|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
614257|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
614258|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks
pertuzumab: 840 mg iv loading, then 420 mg iv every 3 weeks
trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
614259|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks
trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
614260|NCT01026142|E2|Reported Event|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
614261|NCT01026142|E1|Reported Event|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.
Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
614262|NCT01026194|B3|Baseline|Total|Total of all reporting groups
614263|NCT01026194|B2|Baseline|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614360|NCT01026402|P8|Participant Flow|Part A 125mg QD Tab Cont|Continuous QD dosing
614264|NCT01026194|B1|Baseline|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614265|NCT01026194|P2|Participant Flow|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614266|NCT01026194|P1|Participant Flow|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614267|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614268|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614269|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614270|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614271|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614272|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614273|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614274|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
614275|NCT01026194|E4|Reported Event|Teneli/Teneli + Pio (Data Through Week 52)|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
614276|NCT01026194|E3|Reported Event|Placebo/Teneli + Pio (Data From Week 12 to Week 52)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
614277|NCT01026194|E2|Reported Event|Teneli/Teneli + Pio (Data Through Week 12)|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
614278|NCT01026194|E1|Reported Event|Placebo/Teneli + Pio (Data Through Week 12)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
614279|NCT01026220|B1|Baseline|INDUCTION THERAPY (ABVE-PC)|All Patients
614326|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
614280|NCT01026220|P3|Participant Flow|REGIMEN II (SER)|Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-30 minutes on days 1 and 5, and filgrastim SC or IV daily beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
614281|NCT01026220|P2|Participant Flow|REGIMEN I (RER)|Patients receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
614282|NCT01026220|P1|Participant Flow|INDUCTION THERAPY (ABVE-PC)|All Patients
614283|NCT01026220|O3|Outcome|Group 3|Regimen II
614284|NCT01026220|O2|Outcome|Group 2|Regimen I
614285|NCT01026220|O1|Outcome|Group 1|All Patients
614286|NCT01026220|O1|Outcome|Group 1|All Patients
614287|NCT01026220|O2|Outcome|Group 3|Regimen II
614288|NCT01026220|O1|Outcome|Group 2|Regimen I
614289|NCT01026220|O3|Outcome|Group 7|no risk-adapted radiation therapy
614290|NCT01026220|O2|Outcome|Group 6|risk-adapted radiation therapy
614291|NCT01026220|O1|Outcome|Group 1|All Patients
614292|NCT01026220|O3|Outcome|Group 5|RER PET-1 negative
614293|NCT01026220|O2|Outcome|Group 4|RER PET-1 positive
614294|NCT01026220|O1|Outcome|Group 1|All Patients
614295|NCT01026220|O2|Outcome|Group 3|Regimen II
614296|NCT01026220|O1|Outcome|Group 2|Regimen 1
614297|NCT01026220|O1|Outcome|Group 1|All Patients
614298|NCT01026220|O1|Outcome|Group 1|All Patients
614299|NCT01026220|O1|Outcome|Group 1|All Patients
614300|NCT01026220|E3|Reported Event|Group 3|Regimen II
614301|NCT01026220|E2|Reported Event|Group 2|Regimen I
614302|NCT01026220|E1|Reported Event|Group 1|All Patients
614303|NCT01026324|B4|Baseline|Total|Total of all reporting groups
614304|NCT01026324|B3|Baseline|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
614305|NCT01026324|B2|Baseline|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
614306|NCT01026324|B1|Baseline|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
614307|NCT01026324|P3|Participant Flow|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3(30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
614308|NCT01026324|P2|Participant Flow|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
614309|NCT01026324|P1|Participant Flow|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
614310|NCT01026324|O3|Outcome|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV"
614311|NCT01026324|O2|Outcome|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV"
614312|NCT01026324|O1|Outcome|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV"
614313|NCT01026324|O1|Outcome|Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV"
614314|NCT01026324|O1|Outcome|Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV"
614315|NCT01026324|E3|Reported Event|Dose Level 3 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Dose: 30 MG/M2
Dinaciclib: Given IV
Pharmacological study: Correlative studies
Laboratory biomarker analysis: Correlative studies"
614316|NCT01026324|E2|Reported Event|Dose Level 2 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Dose: 20 MG/M2
Dinaciclib: Given IV
Pharmacological study: Correlative studies
Laboratory biomarker analysis: Correlative studies"
614317|NCT01026324|E1|Reported Event|Dose Level 1 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Dose: 10 MG/M2
Dinaciclib: Given IV
Pharmacological study: Correlative studies
Laboratory biomarker analysis: Correlative studies"
614318|NCT01026389|B3|Baseline|Total|Total of all reporting groups
614319|NCT01026389|B2|Baseline|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
614320|NCT01026389|B1|Baseline|Gadovist|Patient received contrast-enhanced MRA with Gadovist
614321|NCT01026389|P2|Participant Flow|Dotarem|Patients received contrast-enhanced MRA with Dotarem
614322|NCT01026389|P1|Participant Flow|Gadovist|Patient received contrast-enhanced MRA with Gadovist
614323|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
614331|NCT01026389|E2|Reported Event|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
614332|NCT01026389|E1|Reported Event|Gadovist|Patient received contrast-enhanced MRA with Gadovist
614333|NCT01026402|B18|Baseline|Total|Total of all reporting groups
614334|NCT01026402|B17|Baseline|Part A 100mg BD Soln Cont|Continuous BD dosing
614335|NCT01026402|B16|Baseline|Part A 70mg BD Soln Cont|Continuous BD dosing
614336|NCT01026402|B15|Baseline|Part B 170mg BD Tab Int|Intermittent BD dosing
614337|NCT01026402|B14|Baseline|Part B 125mg BD Tab Int|Intermittent BD dosing
614338|NCT01026402|B13|Baseline|Part A 225mg BD Tab Int|Intermittent BD dosing
614339|NCT01026402|B12|Baseline|Part A 170mg BD Tab Int|Intermittent BD dosing
614340|NCT01026402|B11|Baseline|Part A 125mg BD Tab Int|Intermittent BD dosing
614341|NCT01026402|B10|Baseline|Part A 100mg BD Tab Int|Intermittent BD dosing
614342|NCT01026402|B9|Baseline|Part A 175mg QD Tab Cont|Continuous QD dosing
614343|NCT01026402|B8|Baseline|Part A 125mg QD Tab Cont|Continuous QD dosing
614344|NCT01026402|B7|Baseline|Part A 100mg QD Tab Cont|Continuous QD dosing
614345|NCT01026402|B6|Baseline|Part A 125mg QD Soln Cont|Continuous QD dosing
614346|NCT01026402|B5|Baseline|Part A 75mg QD Soln Cont|Continuous QD dosing
614347|NCT01026402|B4|Baseline|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614348|NCT01026402|B3|Baseline|Part B 50mg BD Soln Cont|Continuous BD dosing
614349|NCT01026402|B2|Baseline|Part A 50mg BD Soln Cont|Continuous BD dosing
614350|NCT01026402|B1|Baseline|Part A 25mg BD Soln Cont|Continuous BD dosing
614351|NCT01026402|P17|Participant Flow|Part A 100mg BD Soln Cont|Continuous BD dosing
614352|NCT01026402|P16|Participant Flow|Part A 70mg BD Soln Cont|Continuous BD dosing
614353|NCT01026402|P15|Participant Flow|Part B 170mg BD Tab Int|Intermittent BD dosing
614354|NCT01026402|P14|Participant Flow|Part B 125mg BD Tab Int|Intermittent BD dosing
614355|NCT01026402|P13|Participant Flow|Part A 225mg BD Tab Int|Intermittent BD dosing
614356|NCT01026402|P12|Participant Flow|Part A 170mg BD Tab Int|Intermittent BD dosing
614357|NCT01026402|P11|Participant Flow|Part A 125mg BD Tab Int|Intermittent BD dosing
614358|NCT01026402|P10|Participant Flow|Part A 100mg BD Tab Int|Intermittent BD dosing
614361|NCT01026402|P7|Participant Flow|Part A 100mg QD Tab Cont|Continuous QD dosing
614362|NCT01026402|P6|Participant Flow|Part A 125mg QD Soln Cont|Continuous QD dosing
614363|NCT01026402|P5|Participant Flow|Part A 75mg QD Soln Cont|Continuous QD dosing
614364|NCT01026402|P4|Participant Flow|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614365|NCT01026402|P3|Participant Flow|Part B 50mg BD Soln Cont|Continuous BD dosing
614366|NCT01026402|P2|Participant Flow|Part A 50mg BD Soln Cont|Continuous BD dosing
614367|NCT01026402|P1|Participant Flow|Part A 25mg BD Soln Cont|Continuous BD dosing
614368|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614369|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614370|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614371|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614372|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614373|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614374|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614375|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614376|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614377|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614378|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614379|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614380|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614381|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614382|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614383|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614384|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614385|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614386|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614387|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614388|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614389|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614390|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614391|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614392|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614393|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614394|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614395|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614396|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614397|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614398|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614399|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614400|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614401|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614402|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614403|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614404|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614405|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614407|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614408|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614409|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614410|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614411|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614412|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614413|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614414|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614415|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614416|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614417|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614418|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614419|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614420|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614421|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614422|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614423|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614424|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614425|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614426|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614427|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614428|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614429|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614430|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614431|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614432|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614433|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614434|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614435|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614436|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614437|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614438|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614439|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614440|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614441|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614442|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614443|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614444|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614445|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614446|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614447|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614448|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614449|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614450|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614451|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614452|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614453|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614454|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614455|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614456|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614457|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614458|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614459|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614460|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614461|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614462|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614463|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614464|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614465|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614466|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614467|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614468|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614469|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614470|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
614471|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
614472|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614473|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614474|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614475|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614476|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614477|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614478|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614479|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614480|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614481|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614482|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614483|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614484|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614485|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614486|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614487|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614488|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614489|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
614490|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
614491|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614492|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614493|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614494|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614495|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614496|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614497|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614498|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614499|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614500|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614501|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614502|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614503|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614504|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614505|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614506|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614507|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614508|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
614509|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
614510|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614511|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614512|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614513|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614514|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614515|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614516|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614517|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614518|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614519|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614520|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614521|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614522|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614523|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614524|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614525|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614526|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614527|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
614528|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
614529|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614530|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614531|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614532|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614533|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614534|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614535|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614536|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614537|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614538|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614539|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614540|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614541|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614542|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614543|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614544|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614545|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614546|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
614547|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
614548|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614549|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614550|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614551|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614552|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614553|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614554|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614555|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614556|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614557|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614558|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614559|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614560|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614561|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614562|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614563|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614564|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614565|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
614566|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
614567|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614568|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614569|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614570|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614571|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614572|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614573|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614574|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614575|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614576|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614577|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614578|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614579|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614580|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614581|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614582|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614583|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614584|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
614585|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
614586|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614587|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614588|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614589|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614590|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614591|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614592|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614593|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614594|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614595|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614596|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614597|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614598|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614599|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614600|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614601|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614602|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614603|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
614604|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
614605|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614606|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614607|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614608|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614609|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614610|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614611|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614612|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614613|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614614|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614615|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614616|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614617|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614618|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614619|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614620|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614621|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614622|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614623|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614624|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614625|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614626|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614627|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614628|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614629|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614630|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614631|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614632|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614633|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614634|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614635|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614636|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614637|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614638|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614639|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
614640|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
614641|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
614642|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
614643|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
614644|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
614645|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
614646|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
614647|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
614648|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
614649|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
614650|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
614651|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
614652|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
614653|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
614654|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
614655|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
614656|NCT01026402|E18|Reported Event|Part B - Intermittent AZD2014 170 mg BD Tablet|Intermittent BD dosing
614657|NCT01026402|E17|Reported Event|Part B - Intermittent AZD2014 125 mg BD Tablet|Intermittent BD dosing
614658|NCT01026402|E16|Reported Event|Part B - AZD2014 BD 50 mg Tablet Fed/Fasted|Continuous BD dosing
614659|NCT01026402|E15|Reported Event|Part B - AZD2014 50 mg BD Tablet Fasted/Fed|Continuous BD dosing
614660|NCT01026402|E14|Reported Event|Part B - AZD2014 50 mg BD Solution|Continuous BD dosing
614661|NCT01026402|E13|Reported Event|Part A - Intermittent AZD2014 225 mg BD Tablet|Intermittent BD dosing
614662|NCT01026402|E12|Reported Event|Part A - Intermittent AZD2014 170 mg BD Tablet|Intermittent BD dosing
614663|NCT01026402|E11|Reported Event|Part A - Intermittent AZD2014 125 mg BD Tablet|Intermittent BD dosing
614664|NCT01026402|E10|Reported Event|Part A - Intermittent AZD2014 100 mg BD Tablet|Intermittent BD dosing
614665|NCT01026402|E9|Reported Event|Part A - AZD2014 75 mg QD Solution|Continuous QD dosing
614666|NCT01026402|E8|Reported Event|Part A - AZD2014 70 mg BD Solution|Continuous BD dosing
614667|NCT01026402|E7|Reported Event|Part A - AZD2014 50 mg BD Solution|Continuous BD dosing
614668|NCT01026402|E6|Reported Event|Part A - AZD2014 25 mg BD Solution|Continuous BD dosing
614669|NCT01026402|E5|Reported Event|Part A - AZD2014 175 mg QD Tablet|Continuous QD dosing
614670|NCT01026402|E4|Reported Event|Part A - AZD2014 125 mg QD Tablet|Continuous QD dosing
614671|NCT01026402|E3|Reported Event|Part A - AZD2014 125 mg QD Solution|Continous QD dosing
614672|NCT01026402|E2|Reported Event|Part A - AZD2014 100 mg QD Tablet|Continuous QD dosing
614673|NCT01026402|E1|Reported Event|Part A - AZD2014 100 mg BD Solution|Continuous BD dosing
614674|NCT01026454|B3|Baseline|Total|Total of all reporting groups
614675|NCT01026454|B2|Baseline|Valacyclovir Then Acyclovir|valacyclovir 1.5 g orally twice daily for 12 weeks, 2 week washout, then acyclovir 400 mg orally twice daily for 12 weeks
614676|NCT01026454|B1|Baseline|Acyclovir Then Valacyclovir|acyclovir 400 mg orally twice daily for 12 weeks, 2 week washout, then valacyclovir 1.5 g orally twice daily for 12 weeks
614677|NCT01026454|P2|Participant Flow|Valacyclovir Then Acyclovir|Valacyclovir 1.5 g orally twice daily (12 weeks), Washout (2 weeks), Acyclovir 400 mg orally twice daily (12 weeks)
614678|NCT01026454|P1|Participant Flow|Acyclovir Then Valacyclovir|Acyclovir 400 mg orally twice daily (12 weeks), Washout (2 weeks), Valacyclovir 1.5 g orally twice daily (12 weeks)
614679|NCT01026454|O2|Outcome|Valacyclovir|valacyclovir 1.5 g twice daily either in first intervention period or second
614680|NCT01026454|O1|Outcome|Acyclovir|acyclovir 400 mg twice daily 400 mg either in first intervention period or second
614681|NCT01026454|E2|Reported Event|Valacyclovir|valacyclovir 1.5 g twice daily either in first intervention period or second
614682|NCT01026454|E1|Reported Event|Acyclovir|acyclovir 400 mg twice daily 400 mg either in first intervention period or second
614683|NCT01026493|B9|Baseline|Total|Total of all reporting groups
614684|NCT01026493|B8|Baseline|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614685|NCT01026493|B7|Baseline|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
614686|NCT01026493|B6|Baseline|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614687|NCT01026493|B5|Baseline|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
614688|NCT01026493|B4|Baseline|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
614689|NCT01026493|B3|Baseline|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
614690|NCT01026493|B2|Baseline|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
614691|NCT01026493|B1|Baseline|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
614692|NCT01026493|P8|Participant Flow|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614693|NCT01026493|P7|Participant Flow|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
618931|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
614694|NCT01026493|P6|Participant Flow|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614695|NCT01026493|P5|Participant Flow|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
614696|NCT01026493|P4|Participant Flow|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
614697|NCT01026493|P3|Participant Flow|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
614698|NCT01026493|P2|Participant Flow|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
614699|NCT01026493|P1|Participant Flow|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
614700|NCT01026493|O4|Outcome|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614701|NCT01026493|O3|Outcome|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
614702|NCT01026493|O2|Outcome|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614703|NCT01026493|O1|Outcome|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
614704|NCT01026493|O4|Outcome|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614705|NCT01026493|O3|Outcome|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
614706|NCT01026493|O2|Outcome|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614707|NCT01026493|O1|Outcome|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
614708|NCT01026493|O4|Outcome|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614709|NCT01026493|O3|Outcome|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
614710|NCT01026493|O2|Outcome|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614711|NCT01026493|O1|Outcome|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
614712|NCT01026493|O4|Outcome|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
614713|NCT01026493|O3|Outcome|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
614714|NCT01026493|O2|Outcome|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
615273|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
614715|NCT01026493|O1|Outcome|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
614716|NCT01026493|E8|Reported Event|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614717|NCT01026493|E7|Reported Event|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
614718|NCT01026493|E6|Reported Event|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
614719|NCT01026493|E5|Reported Event|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
614720|NCT01026493|E4|Reported Event|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
614721|NCT01026493|E3|Reported Event|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
614722|NCT01026493|E2|Reported Event|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
614723|NCT01026493|E1|Reported Event|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
614724|NCT01026792|B1|Baseline|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
614725|NCT01026792|P1|Participant Flow|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
614726|NCT01026792|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
614727|NCT01026792|E1|Reported Event|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
614728|NCT01026805|B1|Baseline|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
614729|NCT01026805|P1|Participant Flow|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
614730|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
614731|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
614732|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
614733|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
614734|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
614735|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
614736|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
614737|NCT01026805|E1|Reported Event|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
614738|NCT01026818|B4|Baseline|Total|Total of all reporting groups
614739|NCT01026818|B3|Baseline|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614740|NCT01026818|B2|Baseline|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614741|NCT01026818|B1|Baseline|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614742|NCT01026818|P4|Participant Flow|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614743|NCT01026818|P3|Participant Flow|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614744|NCT01026818|P2|Participant Flow|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614745|NCT01026818|P1|Participant Flow|Screen - BNSRP|BNSRP surgery during Screening Period.
614746|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
627947|NCT01059760|O3|Outcome|Change When Fed|
614747|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614748|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614749|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614750|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614751|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614752|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614753|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614754|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614755|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614756|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614757|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614758|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614759|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614760|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614761|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614762|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614883|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614763|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614764|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614765|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614766|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614767|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614768|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614769|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614770|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614771|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614772|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614773|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614774|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614775|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614776|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614777|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614778|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614779|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614780|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614781|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614782|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614783|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614784|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614785|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614786|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614787|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614788|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614789|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614790|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614791|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614792|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614793|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614794|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614795|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614796|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614797|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614798|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614799|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614800|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614801|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614802|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614803|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614804|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614805|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614806|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614807|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614808|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614809|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614810|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614811|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614812|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614813|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614814|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614815|NCT01026818|E7|Reported Event|Placebo (Open-Label Period)|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614816|NCT01026818|E6|Reported Event|Tadalfil 20 mg PRN (Open-Label Period)|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614817|NCT01026818|E5|Reported Event|Tadalafil 5 mg OaD (Open-Label Period)|Tadalafil 5 mg OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
614818|NCT01026818|E4|Reported Event|Placebo (Double-Blind Period/Washout Period)|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
614819|NCT01026818|E3|Reported Event|Tadalafil 20 mg PRN (Double-Blind Period/Washout Period)|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
614820|NCT01026818|E2|Reported Event|Tadalafil 5 mg OaD (Double-Blind Period/Washout Period)|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
614821|NCT01026818|E1|Reported Event|Screen - BNSRP|Had bilateral nerve-sparing radical prostatectomy (BNSRP) surgery during Screening Period.
614822|NCT01026831|B3|Baseline|Total|Total of all reporting groups
614823|NCT01026831|B2|Baseline|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
614824|NCT01026831|B1|Baseline|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
614825|NCT01026831|P2|Participant Flow|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
614826|NCT01026831|P1|Participant Flow|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
614827|NCT01026831|O2|Outcome|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
614828|NCT01026831|O1|Outcome|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
614829|NCT01026831|O2|Outcome|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
614830|NCT01026831|O1|Outcome|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
614831|NCT01026831|E2|Reported Event|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
627948|NCT01059760|O2|Outcome|Change While Fasting|
614832|NCT01026831|E1|Reported Event|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
614833|NCT01026844|B3|Baseline|Total|Total of all reporting groups
614834|NCT01026844|B2|Baseline|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
614835|NCT01026844|B1|Baseline|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
614836|NCT01026844|P2|Participant Flow|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
614837|NCT01026844|P1|Participant Flow|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
614838|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
614839|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
614840|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
614841|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
614842|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
614843|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
614844|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
614845|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
614846|NCT01026844|E2|Reported Event|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
614847|NCT01026844|E1|Reported Event|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
614848|NCT01026909|B3|Baseline|Total|Total of all reporting groups
614849|NCT01026909|B2|Baseline|Control|observation
614850|NCT01026909|B1|Baseline|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
614851|NCT01026909|P2|Participant Flow|Control|Observation
614852|NCT01026909|P1|Participant Flow|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
614853|NCT01026909|O2|Outcome|Control|Observation
614854|NCT01026909|O1|Outcome|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
614855|NCT01026909|O2|Outcome|Control|Observation
614856|NCT01026909|O1|Outcome|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
614857|NCT01026909|E2|Reported Event|Control|Observation
614858|NCT01026909|E1|Reported Event|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
614884|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614885|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614886|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614859|NCT01026948|B1|Baseline|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.
Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.
AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
614860|NCT01026948|P1|Participant Flow|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.
Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.
AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
614861|NCT01026948|O1|Outcome|Acceptability|Maternal views were assessed using semi-structured diaries
614862|NCT01026948|O1|Outcome|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.
Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.
AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
614863|NCT01026948|E1|Reported Event|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.
Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.
AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
614864|NCT01026974|B5|Baseline|Total|Total of all reporting groups
614865|NCT01026974|B4|Baseline|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614866|NCT01026974|B3|Baseline|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614867|NCT01026974|B2|Baseline|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614868|NCT01026974|B1|Baseline|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614869|NCT01026974|P4|Participant Flow|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614870|NCT01026974|P3|Participant Flow|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614871|NCT01026974|P2|Participant Flow|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614872|NCT01026974|P1|Participant Flow|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614873|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614874|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614875|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614876|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614877|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614878|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614879|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614880|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614881|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614882|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
618932|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
614887|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614888|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614889|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614890|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614891|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614892|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614893|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614894|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614895|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614896|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614897|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614898|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614899|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615274|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
614900|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614901|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614902|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614903|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614904|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614905|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614906|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614907|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614908|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614909|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614910|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614911|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614912|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614913|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614914|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614915|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614916|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614917|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614918|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
618933|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
614919|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614920|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614921|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614922|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614923|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614924|NCT01026974|E4|Reported Event|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
614925|NCT01026974|E3|Reported Event|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
614926|NCT01026974|E2|Reported Event|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
614927|NCT01026974|E1|Reported Event|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
614950|NCT01008722|O2|Outcome|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
614951|NCT01008722|O1|Outcome|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
615275|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
614928|NCT01027000|B1|Baseline|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution
Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2
Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3
Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2
Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.
Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
614929|NCT01027000|P1|Participant Flow|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution
Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2
Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3
Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2
Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.
Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
614930|NCT01027000|O1|Outcome|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution
Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2
Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3
Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2
Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.
Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
614931|NCT01027000|E1|Reported Event|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution
Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2
Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3
Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2
Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.
Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
614932|NCT01008696|B3|Baseline|Total|Total of all reporting groups
614933|NCT01008696|B2|Baseline|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
614934|NCT01008696|B1|Baseline|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
615769|NCT01028222|E3|Reported Event|Crossover Nilotinib Treatment|Crossover nilotinib treatment
614935|NCT01008696|P2|Participant Flow|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
614936|NCT01008696|P1|Participant Flow|Rabeprazole|Rabeprazole 20 milligram (mg) tablet orally once daily before breakfast for 28 to 56 days
614937|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole group 30 mg capsule orally once daily before breakfast for 28 to 56 days
614938|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
614939|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole group 30 mg capsule orally once daily before breakfast for 28 to 56 days
614940|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
614941|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
614942|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
614943|NCT01008696|E2|Reported Event|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
614944|NCT01008696|E1|Reported Event|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
614945|NCT01008722|B3|Baseline|Total|Total of all reporting groups
614946|NCT01008722|B2|Baseline|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
614947|NCT01008722|B1|Baseline|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
614948|NCT01008722|P2|Participant Flow|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
614949|NCT01008722|P1|Participant Flow|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
615015|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
614952|NCT01008722|O2|Outcome|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
614953|NCT01008722|O1|Outcome|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
614954|NCT01008722|E2|Reported Event|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
614955|NCT01008722|E1|Reported Event|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
614956|NCT01008904|B1|Baseline|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
614957|NCT01008904|P1|Participant Flow|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
614958|NCT01008904|O1|Outcome|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
614959|NCT01008904|O1|Outcome|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
614960|NCT01008904|E1|Reported Event|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
614961|NCT01008943|B1|Baseline|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
614962|NCT01008943|P1|Participant Flow|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
614963|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
614964|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
614965|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
614966|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
614967|NCT01008943|E1|Reported Event|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
614968|NCT01008969|B1|Baseline|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
614969|NCT01008969|P1|Participant Flow|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
614970|NCT01008969|O1|Outcome|99mTc-sulfur Nanocolloid SPECT/CT|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection.
614971|NCT01008969|O1|Outcome|99mTc-sulfur Nanocolloid SPECT/CT|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection.
614972|NCT01008969|E1|Reported Event|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
614973|NCT01008995|B3|Baseline|Total|Total of all reporting groups
614974|NCT01008995|B2|Baseline|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
614975|NCT01008995|B1|Baseline|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
614976|NCT01008995|P4|Participant Flow|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
614977|NCT01008995|P3|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
614978|NCT01008995|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
614979|NCT01008995|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
614980|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
614981|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
614982|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
614983|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
614984|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
614985|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
614986|NCT01008995|E4|Reported Event|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
614987|NCT01008995|E3|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
614988|NCT01008995|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
614989|NCT01008995|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
614990|NCT01009034|B1|Baseline|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.
Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
615016|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
615276|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
614991|NCT01009034|P1|Participant Flow|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.
Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
614992|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.
Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
614993|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.
Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
614994|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.
Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
614995|NCT01009034|E1|Reported Event|12 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.
Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
614996|NCT01009047|B3|Baseline|Total|Total of all reporting groups
614997|NCT01009047|B2|Baseline|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
614998|NCT01009047|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
614999|NCT01009047|P2|Participant Flow|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
615000|NCT01009047|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
615001|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
615002|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
615003|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
615770|NCT01028222|E2|Reported Event|DTIC|850 mg/m2 IV every 3 weeks
615004|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
615005|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
615006|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
615007|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
615008|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
615009|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
615010|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
615011|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
615012|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
615013|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
615014|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
615277|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
627949|NCT01059760|O1|Outcome|Baseline Value|
615017|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
615018|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
615019|NCT01009047|E2|Reported Event|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
615020|NCT01009047|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
615021|NCT01009086|B4|Baseline|Total|Total of all reporting groups
615022|NCT01009086|B3|Baseline|Group 3: USTEKINUMAB 90 MG|Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
615023|NCT01009086|B2|Baseline|Group 2: USTEKINUMAB 45 MG|Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
615024|NCT01009086|B1|Baseline|Group 1: PLACEBO|Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
615025|NCT01009086|P3|Participant Flow|Group 3: USTEKINUMAB 90 MG|Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
615026|NCT01009086|P2|Participant Flow|Group 2: USTEKINUMAB 45 MG|Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
615027|NCT01009086|P1|Participant Flow|Group 1: PLACEBO|Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
615028|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
615029|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615030|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615031|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
615321|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
615032|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
615033|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615034|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615035|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
615036|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
615037|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615038|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615039|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
615040|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
615041|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615042|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615043|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
615044|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
615045|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615046|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615047|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
615048|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
615049|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615050|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
615051|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
615322|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
615052|NCT01009086|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to ustekinumab 90 mg at Week 0, irrespective of their early escape status.
615053|NCT01009086|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to ustekinumab 45 mg at Week 0, irrespective of their early escape status.
615054|NCT01009086|E5|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to placebo who early escaped to ustekinumab 45 mg at Week 16 or who crossed over to ustekinumab 45 mg at Week 24.
615055|NCT01009086|E4|Reported Event|Placebo (After CP)|After Controlled period (Week 16-24) – participants receiving placebo at Weeks 0, 4, 16, and 20, then crossed over to ustekinumab 45 mg at Week 24.
615056|NCT01009086|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-16) - Ustekinumab 90 mg group. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and 16.
615057|NCT01009086|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-16) - Ustekinumab 45 mg group. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and 16.
615058|NCT01009086|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-16) - Placebo group. Placebo Subcutaneous (SC) injections will be received at Weeks 0, 4 and 16.
615059|NCT01009099|B3|Baseline|Total|Total of all reporting groups
615060|NCT01009099|B2|Baseline|Arm 2|"exercise training
exercise training: treadmill exercise training"
615061|NCT01009099|B1|Baseline|Arm 1|"exercise training with breathing retraining
breathing retraining: breathing retraining using a metronome
exercise training: treadmill exercise training"
615062|NCT01009099|P2|Participant Flow|Exercise Training|treadmill exercise training
615063|NCT01009099|P1|Participant Flow|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
615064|NCT01009099|O2|Outcome|Exercise Training|treadmill exercise training
615065|NCT01009099|O1|Outcome|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
615066|NCT01009099|E2|Reported Event|Exercise Training|treadmill exercise training
615067|NCT01009099|E1|Reported Event|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
615068|NCT01009138|B3|Baseline|Total|Total of all reporting groups
615148|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615278|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
615069|NCT01009138|B2|Baseline|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615070|NCT01009138|B1|Baseline|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615071|NCT01009138|P2|Participant Flow|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615072|NCT01009138|P1|Participant Flow|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615073|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615074|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615075|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615076|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615323|NCT01020877|E2|Reported Event|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
615077|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615078|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615079|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615080|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615081|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615082|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615149|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615279|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
615083|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615084|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615085|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615086|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615087|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615088|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615089|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615090|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615091|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615092|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615093|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615094|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615095|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615096|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615150|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. )
615280|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
615097|NCT01009138|E2|Reported Event|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: Standard Diabetes Education Lesson including
Health Care and specific Topics (e. g. Blood Pressure)
Social Aspects of Living with Diabetes
Diabetes Complications
Sports, Activities and Exercise
Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
615098|NCT01009138|E1|Reported Event|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement"
615099|NCT01009203|B1|Baseline|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
615100|NCT01009203|P1|Participant Flow|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
615101|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
615102|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
615103|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
615104|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
615105|NCT01009203|E1|Reported Event|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
615106|NCT01009333|B1|Baseline|All Study Participants|
615107|NCT01009333|P6|Participant Flow|Start at 25 Hz, Then 14 Hz, Then 5.2 Hz|Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Medium InterStim Rate setting at 14 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
615108|NCT01009333|P5|Participant Flow|Start at 25 Hz, Then 5.2 Hz, Then 14 Hz|Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
615109|NCT01009333|P4|Participant Flow|Start at 14 Hz, Then 25 Hz, Then 5.2 Hz|Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to High InterStim Rate setting at 25 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
615110|NCT01009333|P3|Participant Flow|Start at 14 Hz, Then 5.2 Hz, Then 25 Hz|Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
615111|NCT01009333|P2|Participant Flow|Start at 5.2 Hz, Then 25 Hz, Then 14 Hz|Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to High InterStim Rate Setting at 25 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
615324|NCT01020877|E1|Reported Event|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
615112|NCT01009333|P1|Participant Flow|Start at 5.2 Hz, Then 14 Hz, Then 25 Hz|Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to Medium InterStim Rate Setting at 14 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
615113|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
615114|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
615115|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
615116|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
615117|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
615118|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
615119|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
615120|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
615121|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
615122|NCT01009333|E3|Reported Event|High InterStim Rate Setting at 25 Hz|
615123|NCT01009333|E2|Reported Event|Medium InterStim Rate Setting at 14 Hz|
615124|NCT01009333|E1|Reported Event|Low InterStim Rate Setting at 5.2 Hz|
615125|NCT01009346|B1|Baseline|Study Arm|"Drug: RAD001
Other Names:
Everolimus
Dose Level -1 2.5mg/day
Dose Level 1 5mg/day*
Dose Level 2 10mg/day
MTD RAD001 Drug: Cetuximab
Other Names:
Erbitux
250mg/m2/week Drug: Cisplatin
Other Names:
cisplatinum CDDP cis-diamminedichloroplatinum(II)
40mg/m2 Day 1, 8 every 28 days Drug: Carboplatin
Other Names:
cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II)
Carboplatin will be administered on Day1 and Day 8 of each 28 day cycle to a target AUC of 3 over 30 minutes. Carboplatin will be dosed using the Calvert formula:
Total dose (mg) = (target AUC) x (glomerular filtration rate + 25) Creatinine clearance will be used to estimate the GFR. The Cockgroft-Gault formula will be used to estimate the creatinine clearance."
615126|NCT01009346|P1|Participant Flow|RAD001|Phase I will be a dose finding study to determine the maximum tolerated dose (MTD) of daily RAD001 in combination with weekly cetuximab and cisplatin on Day 1, 8 of each 28 day cycle. The combination will be explored in successive cohorts of 3 patients each. The first cohort of 3 patients will receive doses corresponding to the first dose level. A full safety evaluation will be conducted when these patients have completed 8 weeks of therapy (2 cycles). If 0/3 patients treated at a dose level have a DLT, then a new cohort of 3 patients will receive treatment at the next dose level. If 1/3 patients have even one DLT, then 3 more patients will be treated at same dose level. If none of these patients has a DLT, then the next higher dose level will be administered to the next cohort of 3 patients; otherwise the inferior dose level will be considered the MTD. If >2/3 patients have a DLT, then the inferior dose level will be considered the MTD.
615151|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615281|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
615282|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
615127|NCT01009346|O1|Outcome|Study Arm (RAD001)|Phase I will be a dose finding study to determine the maximum tolerated dose (MTD) of daily RAD001 in combination with weekly cetuximab and cisplatin on Day 1, 8 of each 28 day cycle. The combination will be explored in successive cohorts of 3 patients each. The first cohort of 3 patients will receive doses corresponding to the first dose level. A full safety evaluation will be conducted when these patients have completed 8 weeks of therapy (2 cycles). If 0/3 patients treated at a dose level have a DLT, then a new cohort of 3 patients will receive treatment at the next dose level. If 1/3 patients have even one DLT, then 3 more patients will be treated at same dose level. If none of these patients has a DLT, then the next higher dose level will be administered to the next cohort of 3 patients; otherwise the inferior dose level will be considered the MTD. If >2/3 patients have a DLT, then the inferior dose level will be considered the MTD.
615128|NCT01009346|E1|Reported Event|Group 1|
615129|NCT01009463|B5|Baseline|Total|Total of all reporting groups
615130|NCT01009463|B4|Baseline|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615131|NCT01009463|B3|Baseline|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615132|NCT01009463|B2|Baseline|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615133|NCT01009463|B1|Baseline|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615134|NCT01009463|P5|Participant Flow|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615135|NCT01009463|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615136|NCT01009463|P3|Participant Flow|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615137|NCT01009463|P2|Participant Flow|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615138|NCT01009463|P1|Participant Flow|FP/SAL 250/50 µg BID|Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study.
615139|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615140|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615141|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615142|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615143|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615144|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615145|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615146|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615147|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615268|NCT01020799|P1|Participant Flow|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
615152|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615153|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615154|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615155|NCT01009463|E4|Reported Event|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615156|NCT01009463|E3|Reported Event|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615157|NCT01009463|E2|Reported Event|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615158|NCT01009463|E1|Reported Event|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
615159|NCT01020305|B1|Baseline|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)
IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
615160|NCT01020305|P1|Participant Flow|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)
IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
615161|NCT01020305|O1|Outcome|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)
IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
615162|NCT01020305|E1|Reported Event|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)
IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
615163|NCT01020448|B1|Baseline|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
615164|NCT01020448|P1|Participant Flow|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
615165|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
615166|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
615167|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
615168|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
615169|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
615170|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
615269|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
615270|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
615171|NCT01020448|E1|Reported Event|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
615172|NCT01020474|B3|Baseline|Total|Total of all reporting groups
615173|NCT01020474|B2|Baseline|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
615174|NCT01020474|B1|Baseline|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
615175|NCT01020474|P2|Participant Flow|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
615176|NCT01020474|P1|Participant Flow|Pregabalin|Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
615177|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
615178|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
615179|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
615180|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
615181|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
615182|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
615183|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
615184|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
615185|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
615186|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
615187|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
615188|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
615189|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
615190|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
615191|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
615192|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
615193|NCT01020474|E2|Reported Event|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
615194|NCT01020474|E1|Reported Event|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
615195|NCT01020487|B4|Baseline|Total|Total of all reporting groups
615196|NCT01020487|B3|Baseline|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
615197|NCT01020487|B2|Baseline|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
615198|NCT01020487|B1|Baseline|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
615271|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
615199|NCT01020487|P3|Participant Flow|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
615200|NCT01020487|P2|Participant Flow|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
615201|NCT01020487|P1|Participant Flow|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
615202|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
615203|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
615204|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
615205|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
615206|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
615207|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
615208|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
615209|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
615210|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
615211|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
615212|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
615213|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
615214|NCT01020487|O1|Outcome|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
615215|NCT01020487|O1|Outcome|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
615216|NCT01020487|E5|Reported Event|Part 2: Paricalcitol/Paricalcitol|Participants who received paricalcitol during the double-blind treatment period continued to receive paricalcitol three times a week during the open-label period (Weeks 12-24).
615217|NCT01020487|E4|Reported Event|Part 2: Placebo/Paricalcitol|Participants who received placebo in the double-blind treatment phase received open-label paricalcitol at an initial dose of 1 µg three times a week in the open- label treatment phase (Weeks 12-24). Doses could be adjusted based on chemistry evaluations to target KDOQI levels.
615218|NCT01020487|E3|Reported Event|Part 2: Paricalcitol|Participants received paricalcitol three times a week (TIW) for 12 weeks during the double-blind treatment period. The initial dose of paricalcitol was 1 µg TIW. Doses could be adjusted based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) levels.
615219|NCT01020487|E2|Reported Event|Part 2: Placebo|Participants received placebo capsules three times a week for 12 weeks during the double-blind treatment phase.
615220|NCT01020487|E1|Reported Event|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
615221|NCT01020526|B1|Baseline|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
615222|NCT01020526|P1|Participant Flow|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
615223|NCT01020526|O1|Outcome|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
615224|NCT01020526|E1|Reported Event|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
615225|NCT01020591|B3|Baseline|Total|Total of all reporting groups
615226|NCT01020591|B2|Baseline|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
615227|NCT01020591|B1|Baseline|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
615228|NCT01020591|P2|Participant Flow|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
615229|NCT01020591|P1|Participant Flow|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
615230|NCT01020591|O4|Outcome|Post Test to Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
615231|NCT01020591|O3|Outcome|Same Day Post Test to Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
615232|NCT01020591|O2|Outcome|Pre Test to the Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
615325|NCT01020903|B3|Baseline|Total|Total of all reporting groups
615326|NCT01020903|B2|Baseline|Placebo|Placebo: Orally, pre-op
615327|NCT01020903|B1|Baseline|Aprepitant|Aprepitant: 40 mg po pre-op
615233|NCT01020591|O1|Outcome|Pre Test to the Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
615234|NCT01020591|E2|Reported Event|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
615235|NCT01020591|E1|Reported Event|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
615236|NCT01020747|B1|Baseline|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
615237|NCT01020747|P1|Participant Flow|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
615238|NCT01020747|O2|Outcome|Untreated Vocal Fold|Subjects received saline injections in combination with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the less diseased vocal fold.
615239|NCT01020747|O1|Outcome|Bevacizumab Treated Vocal Fold|Subjects received injections of bevacizumab in conjunction with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the more diseased vocal fold.
615240|NCT01020747|E1|Reported Event|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
615241|NCT01020773|B3|Baseline|Total|Total of all reporting groups
615242|NCT01020773|B2|Baseline|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
615243|NCT01020773|B1|Baseline|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
615244|NCT01020773|P2|Participant Flow|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
615245|NCT01020773|P1|Participant Flow|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
615246|NCT01020773|O2|Outcome|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
615247|NCT01020773|O1|Outcome|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
615248|NCT01020773|E2|Reported Event|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
615249|NCT01020773|E1|Reported Event|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
615272|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
615250|NCT01020786|B1|Baseline|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
615251|NCT01020786|P1|Participant Flow|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
615252|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
615253|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
615254|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
615255|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
615328|NCT01020903|P2|Participant Flow|Placebo|Placebo: Orally, pre-op
615256|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
615257|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
615258|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
615259|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
615260|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m2) of pemetrexed given intravenously (IV) on Day 1 of every 21 day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 for participant, given IV on Day 1 of every 21 day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m2 of pemetrexed given IV on Day 1 of every 21 day cycle until disease progression or unacceptable toxicity."
615261|NCT01020786|E1|Reported Event|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
615262|NCT01020799|B4|Baseline|Total|Total of all reporting groups
615263|NCT01020799|B3|Baseline|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
615264|NCT01020799|B2|Baseline|Placebo|Placebo matching both AZD7268 and escitalopram
615265|NCT01020799|B1|Baseline|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
615266|NCT01020799|P3|Participant Flow|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
615267|NCT01020799|P2|Participant Flow|Placebo|Placebo matching both AZD7268 and escitalopram
615283|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
615284|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
615285|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
615286|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
615287|NCT01020799|E3|Reported Event|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
615288|NCT01020799|E2|Reported Event|Placebo|Placebo matching both AZD7268 and escitalopram
615289|NCT01020799|E1|Reported Event|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
615290|NCT01020812|B1|Baseline|Stereotactic Body Radiotherapy (SBRT)|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.
Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction
TACE: Standard of Care
SBRT: Standard of Care"
615291|NCT01020812|P1|Participant Flow|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.
Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction
TACE: Standard of Care
SBRT: Standard of Care"
615292|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.
Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction
TACE: Standard of Care
SBRT: Standard of Care"
615293|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.
Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction
TACE: Standard of Care
SBRT: Standard of Care"
615329|NCT01020903|P1|Participant Flow|Aprepitant|Aprepitant: 40 mg po pre-op
615330|NCT01020903|O2|Outcome|Placebo|Placebo: Orally, pre-op
615331|NCT01020903|O1|Outcome|Aprepitant|Aprepitant: 40 mg po pre-op
615294|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.
Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction
TACE: Standard of Care
SBRT: Standard of Care"
615295|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.
Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction
TACE: Standard of Care
SBRT: Standard of Care"
615296|NCT01020812|E1|Reported Event|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.
Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction
TACE: Standard of Care
SBRT: Standard of Care"
615297|NCT01020838|B1|Baseline|Safety Analysis Set|All study participants who received any amount of florbetaben were included in the safety analysis set.
615298|NCT01020838|P1|Participant Flow|All Study Participants|All patients enrolling into the study
615299|NCT01020838|O3|Outcome|2nd Repeat Drug Administration|The analysis set consisted of data from 3 subjects with brain specimens available.
615300|NCT01020838|O2|Outcome|1st Repeat Drug Administration|The analysis set consisted of data from 20 subjects with brain specimens available.
615301|NCT01020838|O1|Outcome|Initial Drug Administration|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Descriptive statistics of subject level Composite SUVR by SOT for baseline scans and last available scans are reported.
615302|NCT01020838|O2|Outcome|Specificity of Subject Level Composite SUVR by SOT|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Specificity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
615303|NCT01020838|O1|Outcome|Sensitivity of Subject Level Composite SUVR by SOT|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Sensitivity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
615304|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
615305|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
615392|NCT01021293|B3|Baseline|Total|Total of all reporting groups
627950|NCT01059760|O3|Outcome|Change When Fed|
615306|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
615307|NCT01020838|O2|Outcome|Specificity (Interim Analysis Set)|The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
615308|NCT01020838|O1|Outcome|Sensitivity (Interim Analysis Set)|The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
615309|NCT01020838|E3|Reported Event|2nd Repeat Drug Administration|Subjects with TEAEs within 7 days of the 2nd repeat drug administration.
615310|NCT01020838|E2|Reported Event|1st Repeat Drug Administration|Subjects with TEAEs within 7 days of the 1st repeat drug administration.
615311|NCT01020838|E1|Reported Event|Initial Drug Administration|Subjects with TEAEs within 7 days of the initial administration of florbetaben.
615312|NCT01020877|B3|Baseline|Total|Total of all reporting groups
615313|NCT01020877|B2|Baseline|Reference (MetroGel-Vaginal®) First|0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
615314|NCT01020877|B1|Baseline|Test (Metronidazole) First|0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
615315|NCT01020877|P2|Participant Flow|Reference (MetroGel-Vaginal®) First|0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
615316|NCT01020877|P1|Participant Flow|Test (Metronidazole) First|0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
615317|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
615318|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
615319|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
615320|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
615332|NCT01020903|E2|Reported Event|Placebo|"Placebo: Orally, pre-op Please be advised that the investigator of the study entitled Aprepitant for Post-operative Nausea NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records."
615333|NCT01020903|E1|Reported Event|Aprepitant|"Aprepitant: 40 mg po pre-op Please be advised that the investigator of the study entitled Aprepitant for Post-operative Nausea NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records."
615334|NCT01020981|B3|Baseline|Total|Total of all reporting groups
615335|NCT01020981|B2|Baseline|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
615336|NCT01020981|B1|Baseline|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
615337|NCT01020981|P2|Participant Flow|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
615338|NCT01020981|P1|Participant Flow|Michigan Army National Guard|Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
615339|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
615340|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
615341|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
615342|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
615343|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
615344|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
615469|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
615345|NCT01020981|E2|Reported Event|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
615346|NCT01020981|E1|Reported Event|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
615347|NCT01021007|B3|Baseline|Total|Total of all reporting groups
615348|NCT01021007|B2|Baseline|Iocide Mouthrinse|Experimental mouthrinse
615349|NCT01021007|B1|Baseline|Negative Control Rinse|Placebo mouthrinse
615350|NCT01021007|P2|Participant Flow|Iocide Mouthrinse|Experimental mouthrinse
615351|NCT01021007|P1|Participant Flow|Negative Control Rinse|Placebo mouthrinse
615352|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
615353|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
615354|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
615355|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
615356|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
615357|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
615358|NCT01021007|E2|Reported Event|Iocide Mouthrinse|Experimental mouthrinse
615359|NCT01021007|E1|Reported Event|Negative Control Rinse|Placebo mouthrinse
615360|NCT01021020|B1|Baseline|Colchicine(Fasted),Colchicine(Fed),Colchicine/Probenecid|All subjects received all study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.
615361|NCT01021020|P1|Participant Flow|Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid|All subjects received each of the three study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.
615362|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast.
615363|NCT01021020|O2|Outcome|Colchicine 0.6 mg (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat breakfast.
615364|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
615365|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasting)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast
615366|NCT01021020|O2|Outcome|Colchicine 0.6 mg (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat meal.
615367|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasting)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
615368|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast.
615369|NCT01021020|O2|Outcome|Colchicine (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat breakfast.
615370|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
615371|NCT01021020|E3|Reported Event|Colchicine 0.5 mg/Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg after an overnight fast of at least 13.5 hours.
615372|NCT01021020|E2|Reported Event|Colchicine 0.6 mg (Fed)|Subjects received one tablet of colchicine 0.6 mg after a high-fat meal.
615373|NCT01021020|E1|Reported Event|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6mg after an overnight fast of at least 13.5 hours.
615374|NCT01021111|B1|Baseline|Activity Training With Feedback|Subjects who underwent activity training with feedback
615375|NCT01021111|P1|Participant Flow|Activity Training With Feedback|"Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities
Anterior Cruciate Ligament Measurement and Feedback System"
615376|NCT01021111|O1|Outcome|Activity Training With Feedback|Subjects who underwent activity training with feedback
615377|NCT01021111|O1|Outcome|Activity Training With Feedback|Subjects who underwent activity training with feedback
615378|NCT01021111|E1|Reported Event|Activity Training With Feedback|"Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities
Anterior Cruciate Ligament Measurement and Feedback System"
615379|NCT01021215|B3|Baseline|Total|Total of all reporting groups
615380|NCT01021215|B2|Baseline|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
615381|NCT01021215|B1|Baseline|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
615382|NCT01021215|P2|Participant Flow|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
615383|NCT01021215|P1|Participant Flow|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
615384|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
615385|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
615386|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
615387|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
615388|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
615389|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
615390|NCT01021215|E2|Reported Event|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
615391|NCT01021215|E1|Reported Event|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
615393|NCT01021293|B2|Baseline|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
615394|NCT01021293|B1|Baseline|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
615395|NCT01021293|P2|Participant Flow|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
615396|NCT01021293|P1|Participant Flow|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
615397|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) vaccine at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
615398|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
615399|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
615400|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
615401|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
615402|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
615403|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
615404|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
615405|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
615406|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
615407|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
615408|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
615409|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
615410|NCT01021293|E2|Reported Event|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
615411|NCT01021293|E1|Reported Event|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
615412|NCT01021306|B5|Baseline|Total|Total of all reporting groups
615413|NCT01021306|B4|Baseline|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.
Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
615414|NCT01021306|B3|Baseline|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.
Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
615463|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615464|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615465|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615415|NCT01021306|B2|Baseline|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).
Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
615416|NCT01021306|B1|Baseline|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.
Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
615417|NCT01021306|P4|Participant Flow|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.
Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
615418|NCT01021306|P3|Participant Flow|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.
Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
615419|NCT01021306|P2|Participant Flow|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).
Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
615442|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615771|NCT01028222|E1|Reported Event|Nilotinib|400 mg twice daily
615420|NCT01021306|P1|Participant Flow|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.
Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
615421|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.
Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
615422|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.
Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
615423|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).
Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
615466|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
615518|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
615424|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.
Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
615425|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.
Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
615426|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.
Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
615427|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).
Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
615428|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.
Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
618934|NCT01037218|O4|Outcome|Placebo|Placebo tablets
615429|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.
Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
615430|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.
Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
615431|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).
Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
615432|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.
Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
615467|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
615468|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
627951|NCT01059760|O2|Outcome|Change While Fasting|
615433|NCT01021306|E4|Reported Event|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.
Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
615434|NCT01021306|E3|Reported Event|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.
Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
615435|NCT01021306|E2|Reported Event|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).
Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
615436|NCT01021306|E1|Reported Event|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.
Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
615437|NCT01021332|B1|Baseline|Total Group|Participants who received at least one dose of open-label FDC treatment
615438|NCT01021332|P1|Participant Flow|Total Group|Participants who received at least one dose of open-label FDC treatment
615439|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615440|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615441|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615443|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615444|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615445|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615446|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615447|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057).
615448|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615449|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615450|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615451|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615452|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615453|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615454|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615455|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615456|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615457|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615458|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615459|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057).
615460|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615461|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615462|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
615470|NCT01021332|E1|Reported Event|Total Group|Participants who received at least one dose of open-label FDC treatment
615471|NCT01027195|B3|Baseline|Total|Total of all reporting groups
615472|NCT01027195|B2|Baseline|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
615473|NCT01027195|B1|Baseline|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
615474|NCT01027195|P2|Participant Flow|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
615475|NCT01027195|P1|Participant Flow|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
615476|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
615477|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
615478|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
615479|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
615480|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
615481|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
615482|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
616287|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
615483|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
615484|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
615485|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
615486|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
615487|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
615488|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
615489|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
615490|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
615491|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
615522|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
627952|NCT01059760|O1|Outcome|Baseline Value|
615492|NCT01027195|E2|Reported Event|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
615493|NCT01027195|E1|Reported Event|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
615494|NCT01027273|B3|Baseline|Total|Total of all reporting groups
615495|NCT01027273|B2|Baseline|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.
Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
615496|NCT01027273|B1|Baseline|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.
Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
615497|NCT01027273|P2|Participant Flow|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.
Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
615498|NCT01027273|P1|Participant Flow|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.
Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
615499|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.
Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
615500|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.
Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
615501|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.
Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
615502|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.
Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
615503|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.
Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
615519|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
615520|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
615521|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
615504|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.
Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
615505|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.
Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
615506|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.
Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
615507|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.
Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
615508|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.
Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
615543|NCT01027351|P4|Participant Flow|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615509|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.
Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
615510|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.
Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
615511|NCT01027273|E2|Reported Event|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.
Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
615512|NCT01027273|E1|Reported Event|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.
Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
615513|NCT01027286|B3|Baseline|Total|Total of all reporting groups
615514|NCT01027286|B2|Baseline|Control|No Vitagel used during primary total knee arthroplasty
615515|NCT01027286|B1|Baseline|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
615516|NCT01027286|P2|Participant Flow|Control|No Vitagel used during primary total knee arthroplasty
615517|NCT01027286|P1|Participant Flow|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
615523|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
615524|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
615525|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
615526|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
615527|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
615528|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
615529|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
615530|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
615531|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
615532|NCT01027286|E2|Reported Event|Control|No Vitagel used during primary total knee arthroplasty
615533|NCT01027286|E1|Reported Event|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
615534|NCT01027351|B7|Baseline|Total|Total of all reporting groups
615535|NCT01027351|B6|Baseline|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
615536|NCT01027351|B5|Baseline|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615537|NCT01027351|B4|Baseline|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615538|NCT01027351|B3|Baseline|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615539|NCT01027351|B2|Baseline|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615540|NCT01027351|B1|Baseline|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615541|NCT01027351|P6|Participant Flow|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
615542|NCT01027351|P5|Participant Flow|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615544|NCT01027351|P3|Participant Flow|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615545|NCT01027351|P2|Participant Flow|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615546|NCT01027351|P1|Participant Flow|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615547|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
615548|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615549|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
615550|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615551|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615552|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615553|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615554|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615555|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
615556|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615557|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615558|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
616190|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
615559|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615560|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615561|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615562|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615563|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615564|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615565|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615566|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615567|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615568|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615569|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
615570|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615571|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615572|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615573|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615574|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615575|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
615576|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615577|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615578|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615579|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615580|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615581|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
615582|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615583|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
615584|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615585|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
615586|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615587|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615588|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615589|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615590|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615591|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615592|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615593|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615594|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615595|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615596|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615597|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615598|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615599|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615600|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615601|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615602|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615603|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615604|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615605|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615606|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615607|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615608|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615609|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615759|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
615610|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615611|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615612|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615613|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615614|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615615|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615616|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615617|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615618|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615619|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615620|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615621|NCT01027351|E6|Reported Event|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
615622|NCT01027351|E5|Reported Event|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
615623|NCT01027351|E4|Reported Event|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
615624|NCT01027351|E3|Reported Event|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
615625|NCT01027351|E2|Reported Event|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
615626|NCT01027351|E1|Reported Event|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
615627|NCT01027884|B3|Baseline|Total|Total of all reporting groups
615628|NCT01027884|B2|Baseline|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
615629|NCT01027884|B1|Baseline|Placebo|Two matching placebo tablets were taken three times a day with meals
615630|NCT01027884|P2|Participant Flow|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
615631|NCT01027884|P1|Participant Flow|Placebo|Two matching placebo tablets were taken three times a day with meals
615632|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
615633|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
615634|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
615635|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
615636|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
615637|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
615638|NCT01027884|O2|Outcome|Idebenone|"Idebenone 900 mg/day
Idebenone: Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals"
615639|NCT01027884|O1|Outcome|Placebo|"Placebo 900 mg/day
Placebo: Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals"
615640|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
615641|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
615642|NCT01027884|E2|Reported Event|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
615643|NCT01027884|E1|Reported Event|Placebo|Two matching placebo tablets were taken three times a day with meals
615644|NCT01027897|B1|Baseline|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
615645|NCT01027897|P1|Participant Flow|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
615646|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
615647|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
615648|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
615649|NCT01027897|E1|Reported Event|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
615650|NCT01027910|B3|Baseline|Total|Total of all reporting groups
615651|NCT01027910|B2|Baseline|PCI-24781 + Doxorubicin With Mandatory GCSF|Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, with (Arm B) mandatory G-CSF support was established.
615652|NCT01027910|B1|Baseline|PCI-24781 + Doxorubicin Without Mandatory GCSF|Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, without (Arm A) mandatory G-CSF support was established.
615653|NCT01027910|P2|Participant Flow|PCI-24781 + Doxorubicin With Mandatory GCSF|"PCI-24781 + Doxorubicin with mandatory GCSF
PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle
Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle"
615654|NCT01027910|P1|Participant Flow|PCI-24781 + Doxorubicin Without Mandatory GCSF|"PCI-24781 + Doxorubicin without mandatory GCSF
PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle
Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle"
615655|NCT01027910|O2|Outcome|Mandatory GCSF|
615656|NCT01027910|O1|Outcome|Optional GCSF|
615657|NCT01027910|O2|Outcome|Mandatory GCSF|
615658|NCT01027910|O1|Outcome|Optional GCSF|
615659|NCT01027910|O2|Outcome|Mandatory GCSF|
615660|NCT01027910|O1|Outcome|Optional GCSF|
615661|NCT01027910|O2|Outcome|PCI-24781 With Mandatory GCSF|
615662|NCT01027910|O1|Outcome|PCI-24781 + Doxorubicin Without Mandatory GCSF|
615663|NCT01027910|E2|Reported Event|PCI-24781+Dox With Mandated GCSF|Patients in this are were mandated treatment with GCSF
615664|NCT01027910|E1|Reported Event|PCI-24781+Dox Without Mandated GCSF|Patients in this arm were not mandated treatment with GCSF
615665|NCT01028014|B7|Baseline|Total|Total of all reporting groups
615666|NCT01028014|B6|Baseline|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
615667|NCT01028014|B5|Baseline|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
615668|NCT01028014|B4|Baseline|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
615669|NCT01028014|B3|Baseline|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
615670|NCT01028014|B2|Baseline|Solifenacin 5mg Daily|5 mg capsule, 1 daily for 14 days
615671|NCT01028014|B1|Baseline|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 daily for 14 days
615672|NCT01028014|P6|Participant Flow|Lactose Capsules, One Daily|sham lactose capsules, one daily for 14 days
615673|NCT01028014|P5|Participant Flow|Cyclobenzaprine 10mg Daily|10 mg tablet, one daily for 14 days
615674|NCT01028014|P4|Participant Flow|Imipramine 25mg Daily|25 mg tablet, one daily for 14 days
615675|NCT01028014|P3|Participant Flow|Tamsulosin 0.4mg Daily|0.4 mg capsule, one daily for 14 days
615676|NCT01028014|P2|Participant Flow|Solifenacin 5mg Daily|5 mg capsule, one daily for 14 days
615677|NCT01028014|P1|Participant Flow|Pseudoephedrine 120mg ER Daily|120 mg extended release tablet one daily for 14 days
615678|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
615679|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
615680|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
615681|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
615682|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
615683|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
615684|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
615685|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
615686|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
615687|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
615688|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
615689|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
615690|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
615691|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
615692|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
615693|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
615694|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
615695|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
615696|NCT01028014|E6|Reported Event|Lactose Capsules, One Daily|sham lactose capsules, one daily for 14 days
615697|NCT01028014|E5|Reported Event|Cyclobenzaprine 10mg Daily|10mg tablet, one daily for 14 days
615698|NCT01028014|E4|Reported Event|Imipramine 25mg Daily|25 mg tablet, one daily for 14 days
615699|NCT01028014|E3|Reported Event|Tamsulosin 0.4mg Daily|0.4 mg capsule, one daily for 14 days
615700|NCT01028014|E2|Reported Event|Solifenacin 5mg Daily|5 mg capsule, one daily for 14 days
615701|NCT01028014|E1|Reported Event|Pseudoephedrine 120mg ER Daily|120mg extended release, one daily for 14 days
615702|NCT01028027|B3|Baseline|Total|Total of all reporting groups
615703|NCT01028027|B2|Baseline|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615704|NCT01028027|B1|Baseline|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615705|NCT01028027|P2|Participant Flow|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615706|NCT01028027|P1|Participant Flow|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615707|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615708|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615709|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615710|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615711|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615712|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615713|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615714|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615715|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615740|NCT01028131|O4|Outcome|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
615716|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615717|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615718|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615719|NCT01028027|E2|Reported Event|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615720|NCT01028027|E1|Reported Event|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
615721|NCT01028053|B1|Baseline|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
615722|NCT01028053|P1|Participant Flow|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
615723|NCT01028053|O2|Outcome|Clinically Probable Alzheimer’s Disease|A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to clinically probable Alzheimer’s Disease (pAD).
615724|NCT01028053|O1|Outcome|Not Clinically Probable Alzheimer’s Disease|A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to not clinically probable Alzheimer’s Disease (pAD).
615725|NCT01028053|O1|Outcome|Hazard Ratio|"The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1.
As the HR increases above 1, the chances of being probable Alzheimer’s Disease (pAD) also increases."
615726|NCT01028053|E1|Reported Event|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an intravenous dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
615727|NCT01028131|B5|Baseline|Total|Total of all reporting groups
615728|NCT01028131|B4|Baseline|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
615760|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
615761|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
615762|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
615763|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
615764|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
615729|NCT01028131|B3|Baseline|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples - cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
615730|NCT01028131|B2|Baseline|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
615731|NCT01028131|B1|Baseline|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
615732|NCT01028131|P4|Participant Flow|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
615733|NCT01028131|P3|Participant Flow|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples(looking for clean samples with cotinine less than 100 ng/ml) at prenatal visits. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
615734|NCT01028131|P2|Participant Flow|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
615735|NCT01028131|P1|Participant Flow|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
615736|NCT01028131|O4|Outcome|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
615737|NCT01028131|O3|Outcome|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples -cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
615738|NCT01028131|O2|Outcome|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
615739|NCT01028131|O1|Outcome|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
615741|NCT01028131|O3|Outcome|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples -cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
615742|NCT01028131|O2|Outcome|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
615743|NCT01028131|O1|Outcome|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
615744|NCT01028131|E4|Reported Event|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
615745|NCT01028131|E3|Reported Event|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits. Clean samples (cotinine less than 100 ng/ml) will result in the immediate provision of a $50 Target gift card. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
615746|NCT01028131|E2|Reported Event|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
615747|NCT01028131|E1|Reported Event|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
615748|NCT01028222|B3|Baseline|Total|Total of all reporting groups
615749|NCT01028222|B2|Baseline|DTIC|850 mg/m2 IV every 3 weeks
615750|NCT01028222|B1|Baseline|Nilotinib|400 mg twice daily
615751|NCT01028222|P2|Participant Flow|DTIC|850 mg/m2 IV every 3 weeks
615752|NCT01028222|P1|Participant Flow|Nilotinib|400 mg twice daily
615753|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
615754|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
615755|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
615756|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
615757|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
615758|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
615772|NCT01028300|B1|Baseline|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
615773|NCT01028300|P1|Participant Flow|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
615774|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
615775|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
615776|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
615777|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
615778|NCT01028300|E1|Reported Event|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
615779|NCT01028352|B1|Baseline|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
615832|NCT01028677|P1|Participant Flow|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
616191|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
615780|NCT01028352|P1|Participant Flow|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
615781|NCT01028352|O1|Outcome|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
615782|NCT01028352|O1|Outcome|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
615783|NCT01028352|E1|Reported Event|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
615784|NCT01028378|B1|Baseline|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615785|NCT01028378|P1|Participant Flow|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615786|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615787|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615788|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615789|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615790|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615791|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615792|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615793|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615794|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615795|NCT01028378|E1|Reported Event|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
615796|NCT01028391|B3|Baseline|Total|Total of all reporting groups
615818|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615797|NCT01028391|B2|Baseline|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
615798|NCT01028391|B1|Baseline|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
615799|NCT01028391|P2|Participant Flow|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
615800|NCT01028391|P1|Participant Flow|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
615801|NCT01028391|O2|Outcome|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
615802|NCT01028391|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
616192|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
615803|NCT01028391|O2|Outcome|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
615804|NCT01028391|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
615805|NCT01028391|E2|Reported Event|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
615806|NCT01028391|E1|Reported Event|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
615807|NCT01028651|B1|Baseline|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615808|NCT01028651|P1|Participant Flow|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615809|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615810|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615811|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615812|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615813|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615814|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615815|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615816|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615817|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615819|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615820|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615821|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615822|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615823|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615824|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615825|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615826|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615827|NCT01028651|E1|Reported Event|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
615828|NCT01028677|B3|Baseline|Total|Total of all reporting groups
615829|NCT01028677|B2|Baseline|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
615830|NCT01028677|B1|Baseline|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
615831|NCT01028677|P2|Participant Flow|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 6 weeks"
616193|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
615833|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
615834|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
615835|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
615836|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
615837|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
615838|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
615839|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
615840|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
615841|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
615842|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
615843|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
615844|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
615845|NCT01028677|E2|Reported Event|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
615846|NCT01028677|E1|Reported Event|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
615847|NCT01028820|B1|Baseline|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.
Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
615848|NCT01028820|P1|Participant Flow|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.
Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
615849|NCT01028820|O2|Outcome|Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.
Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
615850|NCT01028820|O1|Outcome|Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.
Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
615851|NCT01028820|O2|Outcome|Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.
Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
615852|NCT01028820|O1|Outcome|Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.
Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
615853|NCT01028820|E1|Reported Event|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.
Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
615854|NCT01028911|B3|Baseline|Total|Total of all reporting groups
615855|NCT01028911|B2|Baseline|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615856|NCT01028911|B1|Baseline|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
616194|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
616195|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
615857|NCT01028911|P2|Participant Flow|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615858|NCT01028911|P1|Participant Flow|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615859|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615860|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615861|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615862|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615863|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615864|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615865|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615866|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
616277|NCT01029886|O2|Outcome|Liraglutide Once Daily With SU Use at Screening|Subcutaneous injection, forced titration to 1.8mg, once daily and with SU use at screening
615867|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615868|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615869|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615870|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615871|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615872|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615873|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
616196|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
615874|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615875|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615876|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615877|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615878|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615879|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615880|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615881|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615882|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615883|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615884|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
618935|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
615885|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615886|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615887|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615888|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615889|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615890|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615891|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
616197|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
616198|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
615892|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615893|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615894|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615895|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615896|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615897|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615898|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615899|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615900|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615901|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615902|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615903|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615904|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615905|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615906|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615907|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615908|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615909|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
616199|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
616200|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
615910|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615911|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615912|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615913|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615914|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615915|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615916|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615917|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615918|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615919|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615920|NCT01028911|E2|Reported Event|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615921|NCT01028911|E1|Reported Event|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
615922|NCT01029054|B1|Baseline|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).
Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.
Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
615923|NCT01029054|P3|Participant Flow|Dose Escalation Cohort 3|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 36 mg/m^2.
Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.
Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
615924|NCT01029054|P2|Participant Flow|Dose Escalation Cohort 2|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 27 mg/m^2.
Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.
Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
615925|NCT01029054|P1|Participant Flow|Dose Escalation Cohort 1|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 20 mg/m^2.
Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.
Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
615926|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).
Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.
Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
616201|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
615927|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).
Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.
Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
615928|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).
Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.
Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
615929|NCT01029054|E1|Reported Event|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).
Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.
Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
615930|NCT01029262|B3|Baseline|Total|Total of all reporting groups
615931|NCT01029262|B2|Baseline|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615932|NCT01029262|B1|Baseline|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615933|NCT01029262|P2|Participant Flow|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615934|NCT01029262|P1|Participant Flow|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615935|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615936|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615937|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615938|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615939|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
616288|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
615940|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615941|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615942|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615943|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615944|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615945|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615946|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615947|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615948|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615949|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615950|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
616202|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
627953|NCT01059760|O3|Outcome|Change When Fed|
615951|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615952|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615953|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615954|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615955|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615956|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615957|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615958|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615959|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615960|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615961|NCT01029262|O2|Outcome|Lenalidomide|".Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615962|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects or withdrawal of consent.
615963|NCT01029262|O2|Outcome|Lenalidomide|".Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615964|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
616278|NCT01029886|O1|Outcome|Exenatide Once Weekly With SU Use at Screening|Subcutaneous injection, 2mg, once weekly and with SU use at screening
615965|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615966|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615967|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615968|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615969|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance between 40 and 60 mL/min."
615970|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects.
615971|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615972|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615973|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615974|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615975|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615976|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615977|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615978|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615979|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615980|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615981|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615982|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615983|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615984|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615985|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
615986|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
615987|NCT01029262|E2|Reported Event|Lenalidomide|Lenalidomide 10 mg daily (QD) by mouth (PO) + 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects. Or 5 mg Lenalidomide capsule + 2 placebo capsules PO QD for participants with a creatinine clearance between 40 and 60 mL/min.
615988|NCT01029262|E1|Reported Event|Placebo|3 placebo capsules PO QD for at least 168 days unless disease progression or intolerable side effects.
615989|NCT01029340|B6|Baseline|Total|Total of all reporting groups
615990|NCT01029340|B5|Baseline|Arm 5: Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
616279|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
616280|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
615991|NCT01029340|B4|Baseline|Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP|Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia for 6 months
615992|NCT01029340|B3|Baseline|Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ|Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months
615993|NCT01029340|B2|Baseline|Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973)|Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between
615994|NCT01029340|B1|Baseline|Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS|Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
615995|NCT01029340|P6|Participant Flow|Arm 6: Recombinant Factor VIII (BAY81-8973) Part B + Extension|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension
615996|NCT01029340|P5|Participant Flow|Arm 5: Recombinant Factor VIII by CS/EP|Part C - Arm 5: Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
615997|NCT01029340|P4|Participant Flow|Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP|Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia (CS/EP) for 6 months
615998|NCT01029340|P3|Participant Flow|Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ|Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
615999|NCT01029340|P2|Participant Flow|Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973)|Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between
616000|NCT01029340|P1|Participant Flow|Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS|Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
616001|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
616002|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
616003|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
616004|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
616005|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
616006|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
616007|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
616008|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
616009|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
616010|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
616011|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
616281|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
616282|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
616012|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
616013|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
616014|NCT01029340|O2|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/ADJ - Part B|Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
616015|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
616016|NCT01029340|O2|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/ADJ - Part B|Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
616017|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
616018|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
616019|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
616020|NCT01029340|O2|Outcome|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
616021|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
616022|NCT01029340|O2|Outcome|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
616023|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
616024|NCT01029340|E4|Reported Event|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants in Part C received a loading dose of approximately 50 IU/kg of BAY81-8973 (nearest whole vial amount) for less than 15 minutes before the first surgical incision. Then they received further treatment with BAY81-8973 according to surgical requirements up to 3 weeks.
616203|NCT01029704|E5|Reported Event|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
627954|NCT01059760|O2|Outcome|Change While Fasting|
616025|NCT01029340|E3|Reported Event|Recombinant Factor VIII (BAY81-8973) Part B and Extension|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension
616026|NCT01029340|E2|Reported Event|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
616027|NCT01029340|E1|Reported Event|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
616028|NCT01029366|B3|Baseline|Total|Total of all reporting groups
616029|NCT01029366|B2|Baseline|ALL Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy
616030|NCT01029366|B1|Baseline|CLL Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy
616031|NCT01029366|P2|Participant Flow|Acute Lymphocytic Leukemia (ALL) Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy. Subjects were given minimum/maximum total dose: 1.5x10⁷/ 5x10⁹
616032|NCT01029366|P1|Participant Flow|Chronic Lymphocytic Leukemia (CLL) Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy. Subjects were given minimum/maximum total dose: 1.5x10⁷/ 5x10⁹.
616033|NCT01029366|O2|Outcome|ALL Subjects|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity
laboratory biomarker analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV
genetically engineered lymphocyte therapy"
616283|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
616284|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
616034|NCT01029366|O1|Outcome|CLL Subjects|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity
laboratory biomarker analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV
genetically engineered lymphocyte therapy"
616035|NCT01029366|O1|Outcome|All Participants|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV
genetically engineered lymphocyte therapy"
616036|NCT01029366|E2|Reported Event|Acute Lymphocytic Leukemia|CART-19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion. Minimum/maximum total dose: 1.5x10^7 / 5x10^9.
616037|NCT01029366|E1|Reported Event|Chronic Lymphocytic Leukemia|CART-19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion. Minimum/maximum total dose: 1.5x10^7 / 5x10^9.
616038|NCT01029392|B3|Baseline|Total|Total of all reporting groups
616039|NCT01029392|B2|Baseline|No Vit D Supplementation|Normal vitamin D levels No Vitamin D supplement
616040|NCT01029392|B1|Baseline|Those Requiring Vit D Supplement|"Those who had a Vit D level of < 30
Vitamin D: 2000iu once a day"
616041|NCT01029392|P2|Participant Flow|No Vitamin D Supplementation|Screening vitamin D level in normal range for children (50-80 ng.mL)
616042|NCT01029392|P1|Participant Flow|Vitamin D Supplement|"Those who had a Vit D level of < 30 ng/mKL
Vitamin D: 2000 IU once a day"
616043|NCT01029392|O2|Outcome|No Vitamin D Supplementation|Screening vitamin D level in normal range for children (50-80 ng.mL)
616044|NCT01029392|O1|Outcome|Vitamin D Supplement|"Those who had a Vit D level of < 30 ng/mKL
Vitamin D: 2000 IU once a day"
616045|NCT01029392|O2|Outcome|No Vitamin D Supplementation|Those with normal vitamin D levels (50-80 ng/mL) No vitamin D supplemenation
616046|NCT01029392|O1|Outcome|Those Requiring Vit D Supplement|Those who had a Vit D level of < 30 Vitamin D: 2000iu once a day
616047|NCT01029392|E2|Reported Event|No Vit D Supplementation|Normal vitamin D levels (50-80 ng/mL) No vitamin D supplementation
616048|NCT01029392|E1|Reported Event|Those Requiring Vit D Supplement|Those who had a Vit D level of < 30 ng/mL Vitamin D: 2000iu once a day
616049|NCT01029405|B5|Baseline|Total|Total of all reporting groups
616050|NCT01029405|B4|Baseline|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616051|NCT01029405|B3|Baseline|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616052|NCT01029405|B2|Baseline|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616204|NCT01029704|E4|Reported Event|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
616053|NCT01029405|B1|Baseline|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616054|NCT01029405|P4|Participant Flow|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616055|NCT01029405|P3|Participant Flow|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616056|NCT01029405|P2|Participant Flow|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616057|NCT01029405|P1|Participant Flow|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent (%) and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616058|NCT01029405|O3|Outcome|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616059|NCT01029405|O2|Outcome|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616060|NCT01029405|O1|Outcome|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616061|NCT01029405|O1|Outcome|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
617540|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
616062|NCT01029405|E4|Reported Event|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616063|NCT01029405|E3|Reported Event|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616064|NCT01029405|E2|Reported Event|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616065|NCT01029405|E1|Reported Event|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
616066|NCT01029535|B1|Baseline|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616067|NCT01029535|P1|Participant Flow|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616068|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616069|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616070|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616071|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616072|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616205|NCT01029704|E3|Reported Event|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
616073|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616074|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616075|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616076|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616077|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616078|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616079|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616080|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
618936|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
616081|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616082|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616083|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616084|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616085|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616086|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616087|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616088|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616089|NCT01029535|E2|Reported Event|Juvederm® VOLUMA™_Phase 2|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616090|NCT01029535|E1|Reported Event|Juvederm® VOLUMA™_Phase 1|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
616091|NCT01029652|B3|Baseline|Total|Total of all reporting groups
616111|NCT01029652|O3|Outcome|Randomized to Canakinumab :After Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
616092|NCT01029652|B2|Baseline|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616093|NCT01029652|B1|Baseline|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616094|NCT01029652|P2|Participant Flow|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. No patient received triamcinolone acetonide in second extension Study ."
616095|NCT01029652|P1|Participant Flow|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study"
616230|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616096|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
616097|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
616098|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
616099|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
616100|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
616112|NCT01029652|O2|Outcome|Randomized to Canakinumab :Before Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
616206|NCT01029704|E2|Reported Event|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
616207|NCT01029704|E1|Reported Event|Placebo|Received no drug (EGT0001442) during 28 days
617392|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
616101|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
616102|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
616103|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
616273|NCT01029886|P2|Participant Flow|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
616274|NCT01029886|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
616104|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
616105|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
616106|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
616107|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
616108|NCT01029652|O6|Outcome|Randomized to Triam: After Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
616109|NCT01029652|O5|Outcome|Randomized to Triam: Before Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
616110|NCT01029652|O4|Outcome|Randomized to Triamcinolone Acetonide (Triam)|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab"
616185|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
616186|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
616113|NCT01029652|O1|Outcome|All Randomized to Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
616114|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
616115|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616275|NCT01029886|O4|Outcome|Liraglutide Once Daily Without SU Use at Screening|Subcutaneous injection, forced titration to 1.8mg, once daily and without SU use at screening
616285|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
616116|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
616117|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616118|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. Note that flare rate was calculated using only those new flares before switching."
616119|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
616120|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period
616121|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
616122|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616187|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
627955|NCT01059760|O1|Outcome|Baseline Value|
616123|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616124|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616125|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616229|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616286|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
616126|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616127|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616128|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616129|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616130|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616131|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616132|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
616133|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
616134|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616188|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
616189|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
616135|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616136|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616137|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616138|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616139|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616140|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616141|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616142|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616143|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616144|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616145|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616146|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616147|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
627956|NCT01059760|O3|Outcome|Change When Fed|
616148|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616149|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616150|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616151|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616152|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616153|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616154|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616155|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616156|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616157|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616158|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616159|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616160|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
627957|NCT01059760|O2|Outcome|Change While Fasting|
616161|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616162|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616163|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616164|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616165|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
616166|NCT01029652|E6|Reported Event|Randomized to Triam: After Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
616167|NCT01029652|E5|Reported Event|Randomized to Triam: Before Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
616168|NCT01029652|E4|Reported Event|All Randomized to Triamcinolone Acetonide (Triam)|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab"
616169|NCT01029652|E3|Reported Event|Randomized to Canakinumab :After Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
616170|NCT01029652|E2|Reported Event|Randomized to Canakinumab :Before Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
616171|NCT01029652|E1|Reported Event|All Randomized to Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
616172|NCT01029704|B6|Baseline|Total|Total of all reporting groups
616173|NCT01029704|B5|Baseline|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
616174|NCT01029704|B4|Baseline|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
616175|NCT01029704|B3|Baseline|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
616176|NCT01029704|B2|Baseline|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
616177|NCT01029704|B1|Baseline|Placebo|Received no drug (EGT0001442) during 28 days
616178|NCT01029704|P5|Participant Flow|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
616179|NCT01029704|P4|Participant Flow|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
616180|NCT01029704|P3|Participant Flow|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
616181|NCT01029704|P2|Participant Flow|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
616182|NCT01029704|P1|Participant Flow|Placebo|Received no drug (EGT0001442) during 28 days
616183|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
616184|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
616208|NCT01029730|B1|Baseline|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
616209|NCT01029730|P1|Participant Flow|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
616210|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
616211|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
616212|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
616213|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
616214|NCT01029730|E1|Reported Event|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
616215|NCT01029795|B3|Baseline|Total|Total of all reporting groups
616216|NCT01029795|B2|Baseline|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616217|NCT01029795|B1|Baseline|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616218|NCT01029795|P2|Participant Flow|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616219|NCT01029795|P1|Participant Flow|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616220|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616221|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616222|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616223|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616224|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616308|NCT01024244|B1|Baseline|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616225|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616226|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616227|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616228|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616276|NCT01029886|O3|Outcome|Exenatide Once Weekly Without SU Use at Screening|Subcutaneous injection, 2mg, once weekly and without SU use at screening
616231|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616232|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616233|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616234|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616235|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616236|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616237|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616238|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616239|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616240|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616241|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616242|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616243|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616244|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616345|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616245|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616246|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616247|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616248|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616249|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616250|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616251|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616252|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616253|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616254|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616255|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616256|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616257|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616258|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616259|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616260|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616261|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616262|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616263|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616264|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616346|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616265|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616266|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616267|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616268|NCT01029795|E2|Reported Event|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
616269|NCT01029795|E1|Reported Event|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
616270|NCT01029886|B3|Baseline|Total|Total of all reporting groups
616271|NCT01029886|B2|Baseline|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
616272|NCT01029886|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
616289|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
616290|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
616291|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
616292|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
616293|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
616294|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
616295|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
616296|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
616297|NCT01029886|E2|Reported Event|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
616298|NCT01029886|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
616299|NCT01029925|B1|Baseline|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
616300|NCT01029925|P1|Participant Flow|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
616301|NCT01029925|O1|Outcome|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
616302|NCT01029925|E1|Reported Event|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
616303|NCT01024244|B6|Baseline|Total|Total of all reporting groups
616304|NCT01024244|B5|Baseline|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616305|NCT01024244|B4|Baseline|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616306|NCT01024244|B3|Baseline|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616307|NCT01024244|B2|Baseline|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616518|NCT01031979|B2|Baseline|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo"
616309|NCT01024244|P5|Participant Flow|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616310|NCT01024244|P4|Participant Flow|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616311|NCT01024244|P3|Participant Flow|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616312|NCT01024244|P2|Participant Flow|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616313|NCT01024244|P1|Participant Flow|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616314|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616315|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616316|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616317|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616318|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616319|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616320|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616321|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616322|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616323|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616324|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616325|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616326|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616327|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616328|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616329|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616330|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616331|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616332|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616333|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616334|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616335|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616336|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616337|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616338|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616339|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616340|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616341|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616342|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616343|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616344|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616347|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616348|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616349|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616350|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616351|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616352|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616353|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616354|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616355|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616356|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616357|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616358|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616359|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616360|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616361|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616362|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616363|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616364|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616365|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616366|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616367|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
618937|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
616368|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616369|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616370|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616371|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616372|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616373|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616374|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616375|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616376|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616377|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616378|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616379|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616380|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616381|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616382|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
617794|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
616383|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616384|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616385|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616386|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616387|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616388|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616389|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616390|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616391|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616392|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616393|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616394|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616395|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616396|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616397|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616398|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616399|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616400|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616401|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616402|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616403|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616404|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616405|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616406|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616407|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616408|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616409|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616410|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616411|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616412|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616413|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616414|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616415|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616416|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616417|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616418|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
617075|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
616419|NCT01024244|E5|Reported Event|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
616420|NCT01024244|E4|Reported Event|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616421|NCT01024244|E3|Reported Event|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
616422|NCT01024244|E2|Reported Event|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
616423|NCT01024244|E1|Reported Event|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
616424|NCT01024309|B3|Baseline|Total|Total of all reporting groups
616425|NCT01024309|B2|Baseline|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
616426|NCT01024309|B1|Baseline|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
616427|NCT01024309|P2|Participant Flow|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
616428|NCT01024309|P1|Participant Flow|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
616429|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
616430|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
616431|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
616432|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
616433|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
616434|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
616435|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
616436|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
616437|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
616438|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
616439|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
616440|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
616441|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
616442|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
616443|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
616444|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
616445|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
616446|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
616447|NCT01024309|E2|Reported Event|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty: Direct Anterior surgical approach for total hip arthroplasty
616448|NCT01024309|E1|Reported Event|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty: Mini-Posterior surgical approach for total hip arthroplasty
616449|NCT01024335|B3|Baseline|Total|Total of all reporting groups
616450|NCT01024335|B2|Baseline|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
616451|NCT01024335|B1|Baseline|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
616452|NCT01024335|P2|Participant Flow|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
616453|NCT01024335|P1|Participant Flow|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
616454|NCT01024335|O2|Outcome|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
616455|NCT01024335|O1|Outcome|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
616515|NCT01031953|O1|Outcome|Participants Receiving Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
616456|NCT01024335|O2|Outcome|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
616457|NCT01024335|O1|Outcome|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
616458|NCT01024335|E2|Reported Event|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
616459|NCT01024335|E1|Reported Event|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
616460|NCT01024465|B1|Baseline|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon
ReShape Duo Balloon: ReShape Duo Balloon"
616461|NCT01024465|P1|Participant Flow|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon
ReShape Duo Balloon: ReShape Duo Balloon"
616462|NCT01024465|O1|Outcome|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon
ReShape Duo Balloon: ReShape Duo Balloon"
616463|NCT01024465|E1|Reported Event|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon
ReShape Duo Balloon: ReShape Duo Balloon"
616464|NCT01030458|B3|Baseline|Total|Total of all reporting groups
616465|NCT01030458|B2|Baseline|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
616466|NCT01030458|B1|Baseline|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
616467|NCT01030458|P2|Participant Flow|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg and to achieve blood pressure control, the study medication could be up-titrated to 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
616468|NCT01030458|P1|Participant Flow|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and to achieve blood pressure control, the study medication could be up-titrated to amlodipine 10 mg plus 160 mg valsartan. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
618938|NCT01037218|O4|Outcome|Placebo|Placebo tablets
616469|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
616470|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
616471|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
616472|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
616473|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
616474|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
616475|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
616476|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
616477|NCT01030458|E2|Reported Event|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
616478|NCT01030458|E1|Reported Event|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
616479|NCT01030653|B3|Baseline|Total|Total of all reporting groups
616480|NCT01030653|B2|Baseline|Voriconazole Low Dose First Then High Dose|
616481|NCT01030653|B1|Baseline|Voriconazole High Dose First Then Low Dose|Both voriconazole arms are shown as a single group because the same individuals received both arms of the intervention in a cross-over design.
616482|NCT01030653|P2|Participant Flow|Voriconazole Low Dose First Then High Dose|Active: Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Two Fixed Maintenance Doses ( 200 mg Every 12 Hours x 7 Doses) followed by a 7-day washout period then a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses ( 300 mg Every 12 Hours x 7 Doses)
616516|NCT01031953|E1|Reported Event|Fosaprepitant|
616483|NCT01030653|P1|Participant Flow|Voriconazole High Dose First Then Low Dose|Active: Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Two Fixed Maintenance Doses ( 300 mg Every 12 Hours x 7 Doses) followed by a 7-day washout period then a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses ( 200 mg Every 12 Hours x 7 Doses)
616484|NCT01030653|O2|Outcome|Voriconazole Higher Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
616485|NCT01030653|O1|Outcome|Voriconazole Lower Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
616486|NCT01030653|O1|Outcome|Voriconazole High : Low Dose|"Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)"
616487|NCT01030653|O2|Outcome|Voriconazole Higher Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
616488|NCT01030653|O1|Outcome|Voriconazole Lower Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
616489|NCT01030653|E2|Reported Event|Voriconazole Low Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
616490|NCT01030653|E1|Reported Event|Voriconazole High Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
616491|NCT01030666|B3|Baseline|Total|Total of all reporting groups
616492|NCT01030666|B2|Baseline|Placebo|The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
616493|NCT01030666|B1|Baseline|Doxycycline|The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
616494|NCT01030666|P2|Participant Flow|Placebo|The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
616495|NCT01030666|P1|Participant Flow|Doxycycline|The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
616496|NCT01030666|O2|Outcome|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to
modified/simplified papilla preservation flap; scaling
Prefgel/Emdogain
0.12% chlorhexidine gluconate solution
Ibuprofen 400 mg (if necessary)
1% chlorhexidine gluconate gel (if necessary)"
616497|NCT01030666|O1|Outcome|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to
modified/simplified papilla preservation flap; scaling
Prefgel/Emdogain
0.12% chlorhexidine gluconate solution
Ibuprofen 400 mg (if necessary)
1% chlorhexidine gluconate gel (if necessary)"
616498|NCT01030666|O2|Outcome|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to
modified/simplified papilla preservation flap; scaling
Prefgel/Emdogain
0.12% chlorhexidine gluconate solution
Ibuprofen 400 mg (if necessary)
1% chlorhexidine gluconate gel (if necessary)"
616561|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616499|NCT01030666|O1|Outcome|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects addionally to
modified/simplified papilla preservation flap; scaling
Prefgel/Emdogain
0.12% chlorhexidine gluconate solution
Ibuprofen 400 mg (if necessary)
1% chlorhexidine gluconate gel (if necessary)"
616500|NCT01030666|E2|Reported Event|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to
modified/simplified papilla preservation flap; scaling
Prefgel/Emdogain
0.12% chlorhexidine gluconate solution
Ibuprofen 400 mg (if necessary)
1% chlorhexidine gluconate gel (if necessary)"
616501|NCT01030666|E1|Reported Event|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to
modified/simplified papilla preservation flap; scaling
Prefgel/Emdogain
0.12% chlorhexidine gluconate solution
Ibuprofen 400 mg (if necessary)
1% chlorhexidine gluconate gel (if necessary)"
616502|NCT01031914|B1|Baseline|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
616503|NCT01031914|P1|Participant Flow|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have obstructive sleep apnea (OSA) and will be current CPAP users.
616504|NCT01031914|O1|Outcome|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
616505|NCT01031914|E1|Reported Event|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
616506|NCT01031953|B1|Baseline|Fosaprepitant|
616507|NCT01031953|P1|Participant Flow|Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
616508|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|Only those in the study arm above that self report headache, dizziness, or pain/soreness at the infusion site are considered in this outcome
616509|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|participants with self report fatigue or sedation after receiving fosaprepitant
616510|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|Number of participants achieving a Complete Response (CR) up to 24 hours after receiving fosaprepitant
616511|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|This arm includes only those participants that required the use of second rescue drug after receiving Fosaprepitant
616512|NCT01031953|O1|Outcome|Participants Who Recieved Fosaprepitant|Number of participants who experienced vomiting episodes from baseline to 24 hours after receiving Fosaprepitant
616513|NCT01031953|O1|Outcome|Change in Nausea Score From 2 Hours to 12 and 24 Hours|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
616514|NCT01031953|O1|Outcome|Participants Receiving Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
616519|NCT01031979|B1|Baseline|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist"
616520|NCT01031979|P2|Participant Flow|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo"
616521|NCT01031979|P1|Participant Flow|Yohimbime Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist"
616522|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo"
616523|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist"
616524|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo"
616525|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist"
616526|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo"
616527|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist"
616528|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo"
616529|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist"
616530|NCT01031979|E2|Reported Event|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.
Placebo: Placebo"
616531|NCT01031979|E1|Reported Event|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.
Yohimbine: alpha-2 adrenergic receptor antagonist"
616532|NCT01032018|B3|Baseline|Total|Total of all reporting groups
616533|NCT01032018|B2|Baseline|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
616534|NCT01032018|B1|Baseline|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
616535|NCT01032018|P2|Participant Flow|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
616536|NCT01032018|P1|Participant Flow|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
616537|NCT01032018|O2|Outcome|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
616538|NCT01032018|O1|Outcome|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
616539|NCT01032018|O2|Outcome|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
616540|NCT01032018|O1|Outcome|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
616541|NCT01032018|E2|Reported Event|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
616542|NCT01032018|E1|Reported Event|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
616543|NCT01032044|B3|Baseline|Total|Total of all reporting groups
616544|NCT01032044|B2|Baseline|pCLE-guided Evaluation|"Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)
pCLE guided evaluation: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
616545|NCT01032044|B1|Baseline|Standard Endoscopic Evaluation|"Standard high-definition white light endoscopy guided evaluation
Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
616546|NCT01032044|P2|Participant Flow|pCLE-guided Treatment|"Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy
pCLE guided endoscopic treatment of BE: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
616547|NCT01032044|P1|Participant Flow|Standard Treatment|"Standard high-definition white light endoscopy guided treatment
Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
616548|NCT01032044|O2|Outcome|pCLE-guided Evaluation|"Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)
pCLE guided evaluation: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
616549|NCT01032044|O1|Outcome|Standard Endoscopic Evaluation|"Standard high-definition white light endoscopy guided evaluation
Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
616550|NCT01032044|E2|Reported Event|pCLE-guided Treatment|"Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy
pCLE guided endoscopic treatment of BE: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
616551|NCT01032044|E1|Reported Event|Standard Treatment|"Standard high-definition white light endoscopy guided treatment
Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
616552|NCT01032070|B3|Baseline|Total|Total of all reporting groups
616553|NCT01032070|B2|Baseline|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616554|NCT01032070|B1|Baseline|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616555|NCT01032070|P2|Participant Flow|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616556|NCT01032070|P1|Participant Flow|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616557|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616558|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616559|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616560|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
618939|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
616562|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616563|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616564|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616565|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616566|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616567|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616568|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616569|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616570|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616571|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616572|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616573|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616841|NCT01032265|B2|Baseline|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
616574|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616575|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616576|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616577|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616578|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616579|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616580|NCT01032070|E2|Reported Event|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616581|NCT01032070|E1|Reported Event|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
616582|NCT01032135|B6|Baseline|Total|Total of all reporting groups
616583|NCT01032135|B5|Baseline|MI-IOP Engaged at 2 Weeks, Non-engaged Before 8 Weeks|"Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized back to IOP.
Motivational Interviewing: 2 sessions at week 2."
616584|NCT01032135|B4|Baseline|MI-PC Engaged at 2 Weeks, Non-engaged Before 8 Weeks|"Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616585|NCT01032135|B3|Baseline|MI-IOP Non-Engaged|"Participants began treatment in IOP but were not engaged at week 2. Randomized back to IOP.
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616586|NCT01032135|B2|Baseline|MI-PC Non-Engaged|"Participants began treatment in IOP but were not engaged at week 2. Randomized to receive patient choice.
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616587|NCT01032135|B1|Baseline|Engaged|Participants began treatment in IOP, consistently remained engaged in IOP throughout the study time period. This group did not reach the threshold of needing study intervention.
616588|NCT01032135|P7|Participant Flow|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616589|NCT01032135|P6|Participant Flow|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616590|NCT01032135|P5|Participant Flow|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616591|NCT01032135|P4|Participant Flow|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616592|NCT01032135|P3|Participant Flow|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616593|NCT01032135|P2|Participant Flow|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616594|NCT01032135|P1|Participant Flow|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616595|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616596|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616842|NCT01032265|B1|Baseline|Postal Treatment|Information (including life style), and PFMT exercises.
616597|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616598|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616599|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616600|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616601|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616602|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616603|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616604|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616605|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616606|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616607|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
618940|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
616608|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616609|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616610|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616611|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616612|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616613|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616614|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616615|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616616|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616617|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616618|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616619|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616620|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616621|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616622|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616623|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616624|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616625|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616626|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616627|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616628|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616629|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616630|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616631|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616632|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616633|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616634|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616635|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616636|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616637|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616638|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616639|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616640|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616641|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616642|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616643|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616644|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616645|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616646|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616647|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616648|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616649|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616650|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616651|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616652|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616653|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616654|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616655|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616656|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616657|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616658|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616659|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616660|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616661|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616662|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616663|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616664|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616665|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616666|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616667|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616668|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616669|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616670|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616671|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616672|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616673|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616674|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616675|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616676|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616677|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616678|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616679|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616680|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616681|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616682|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616683|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616684|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616685|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616686|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616687|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616688|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616689|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616690|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616691|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616692|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616693|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616694|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616695|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616696|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616697|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616698|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616699|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616700|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616701|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616702|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616703|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616704|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616705|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616706|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616707|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616708|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616709|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616710|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616711|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616712|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616713|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616714|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616715|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616716|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616717|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616718|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616719|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616720|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616721|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616722|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616723|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616724|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616725|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616726|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616727|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616728|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616729|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616730|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616731|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616732|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616733|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616734|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616735|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616736|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616737|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616738|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616739|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616740|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616741|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616742|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616743|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616744|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616745|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616746|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616747|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616748|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616749|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616750|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616751|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616752|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616753|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616754|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616755|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616756|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616757|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616758|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616759|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616760|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616761|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616762|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616763|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616764|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616765|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616766|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616767|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616768|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616769|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616770|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616771|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616772|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616773|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616774|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616775|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616776|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616777|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616778|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616779|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616780|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616781|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616782|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616783|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616784|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616785|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616786|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616787|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616788|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616789|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616790|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616791|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616792|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616793|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616794|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616795|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616796|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616797|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616798|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.
Randomized to receive no further study intervention."
616799|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.
Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616800|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.
Motivational Interviewing: 2 sessions at time of disengagement.
Return to IOP therapy 3 times weekly for three hours a day"
616801|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for Naltrexone"
616802|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616803|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616804|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.
This group did not receive any treatment intervention."
616805|NCT01032135|E5|Reported Event|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become non-engaged in weeks 3 - 8.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2"
616839|NCT01032200|E1|Reported Event|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally"
616840|NCT01032265|B3|Baseline|Total|Total of all reporting groups
618232|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
616806|NCT01032135|E4|Reported Event|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Participants start at IOP, Engaged at 2 weeks but disengage between 3 - 8 weeks.
Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616807|NCT01032135|E3|Reported Event|MI-IOP Non-Engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are non-engaged.
Randomized to IOP
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
616808|NCT01032135|E2|Reported Event|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are non-engaged.
Randomized to treatment choice:
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
Medication Management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
616809|NCT01032135|E1|Reported Event|Engaged|Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.
616810|NCT01032174|B3|Baseline|Total|Total of all reporting groups
616811|NCT01032174|B2|Baseline|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616812|NCT01032174|B1|Baseline|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616813|NCT01032174|P2|Participant Flow|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616814|NCT01032174|P1|Participant Flow|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616815|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616816|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616817|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616818|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616819|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616820|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616821|NCT01032174|E2|Reported Event|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616822|NCT01032174|E1|Reported Event|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616823|NCT01032200|B3|Baseline|Total|Total of all reporting groups
616824|NCT01032200|B2|Baseline|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
616825|NCT01032200|B1|Baseline|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally"
616826|NCT01032200|P2|Participant Flow|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
616827|NCT01032200|P1|Participant Flow|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally"
616828|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
616829|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally"
616830|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
616831|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally"
616832|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
616833|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally"
616834|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
616835|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally"
616836|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
616837|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally"
616838|NCT01032200|E2|Reported Event|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally"
616843|NCT01032265|P2|Participant Flow|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
616844|NCT01032265|P1|Participant Flow|Postal Treatment|Information (including life style), and PFMT exercises.
616845|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
616846|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
616847|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
616848|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
616849|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
616850|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
616851|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
616852|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
616853|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
616854|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
616855|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
616856|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
616857|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
616858|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
616859|NCT01032265|E2|Reported Event|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
616860|NCT01032265|E1|Reported Event|Postal Treatment|Information (including life style), and PFMT exercises.
616861|NCT01032291|B4|Baseline|Total|Total of all reporting groups
616862|NCT01032291|B3|Baseline|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616863|NCT01032291|B2|Baseline|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
616864|NCT01032291|B1|Baseline|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616936|NCT01032694|E2|Reported Event|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616865|NCT01032291|P3|Participant Flow|Lenalidomide + Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616866|NCT01032291|P2|Participant Flow|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
616867|NCT01032291|P1|Participant Flow|Lenalidomide + Cetuximab (Safety Lead-in)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616868|NCT01032291|O2|Outcome|Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616869|NCT01032291|O1|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
616870|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616871|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
616872|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616873|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616874|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
616875|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616909|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
617076|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
616876|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616877|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
616878|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616879|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616880|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
616881|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616882|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616883|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
616884|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616885|NCT01032291|O2|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616886|NCT01032291|O1|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
616887|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-in)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616888|NCT01032291|E2|Reported Event|Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
616889|NCT01032291|E1|Reported Event|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
616890|NCT01032382|B3|Baseline|Total|Total of all reporting groups
616891|NCT01032382|B2|Baseline|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616892|NCT01032382|B1|Baseline|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616893|NCT01032382|P2|Participant Flow|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616894|NCT01032382|P1|Participant Flow|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616895|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616896|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616897|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616898|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616899|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616900|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616901|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616902|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616903|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616904|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616905|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616906|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616907|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616908|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616910|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616911|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616912|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616913|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616914|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616915|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616916|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616917|NCT01032382|E2|Reported Event|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
616918|NCT01032382|E1|Reported Event|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
616919|NCT01032538|B1|Baseline|Patients With Knee Osteoarthritis|Patients eglible for medial unicompartmental knee replacement
616920|NCT01032538|P1|Participant Flow|Patients With Knee Osteoarthritis|Patients eglible for unicondylar knee replacement
616921|NCT01032538|O1|Outcome|Passive ROM 2 Years|Range of motion measured by physiotherapist
616922|NCT01032538|O2|Outcome|KOOS ADL 2 Years|Activities of dayly living score
616923|NCT01032538|O1|Outcome|KOOS Pain 2 Years|Knee pain score, one of 5 subscores of KOOS
616924|NCT01032538|E1|Reported Event|Patients With Knee Osteoarthritis|Patients eglible for unicompartmental knee replacement
616925|NCT01032694|B3|Baseline|Total|Total of all reporting groups
616926|NCT01032694|B2|Baseline|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616927|NCT01032694|B1|Baseline|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616928|NCT01032694|P2|Participant Flow|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616929|NCT01032694|P1|Participant Flow|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616930|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616931|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616932|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616933|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616934|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
616935|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616937|NCT01032694|E1|Reported Event|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
616938|NCT01032733|B3|Baseline|Total|Total of all reporting groups
616939|NCT01032733|B2|Baseline|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
616940|NCT01032733|B1|Baseline|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
616941|NCT01032733|P2|Participant Flow|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
616942|NCT01032733|P1|Participant Flow|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
616943|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
616944|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
616945|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
616946|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
616947|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
616948|NCT01032733|O1|Outcome|Lifestyle Counseling|
616949|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
616950|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
616951|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
616952|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
616953|NCT01032733|E2|Reported Event|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
616954|NCT01032733|E1|Reported Event|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
616955|NCT01032759|B3|Baseline|Total|Total of all reporting groups
616977|NCT01032837|B4|Baseline|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
616978|NCT01032837|B3|Baseline|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
616979|NCT01032837|B2|Baseline|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
616980|NCT01032837|B1|Baseline|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
616981|NCT01032837|P4|Participant Flow|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
616982|NCT01032837|P3|Participant Flow|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
616983|NCT01032837|P2|Participant Flow|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
616984|NCT01032837|P1|Participant Flow|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
616985|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
616986|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
616987|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
617281|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
616988|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
616989|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
616990|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
616991|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
616992|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
616993|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
616994|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
616995|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
616996|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
616997|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
616998|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
616999|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
617000|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617001|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
617002|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617003|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
617004|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617005|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
617006|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617007|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
617008|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617009|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
617010|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617011|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
617012|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617013|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
617014|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617015|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
617016|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617017|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
617018|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617019|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
617020|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617021|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
617022|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617023|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
617024|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617025|NCT01032837|E4|Reported Event|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
617026|NCT01032837|E3|Reported Event|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617027|NCT01032837|E2|Reported Event|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
617028|NCT01032837|E1|Reported Event|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
617053|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
618941|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
617029|NCT01032850|B1|Baseline|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
617030|NCT01032850|P1|Participant Flow|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
617031|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
617032|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
617033|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
617034|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
617035|NCT01032850|E1|Reported Event|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
617036|NCT01032889|B4|Baseline|Total|Total of all reporting groups
617037|NCT01032889|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617038|NCT01032889|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617039|NCT01032889|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617040|NCT01032889|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617041|NCT01032889|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617042|NCT01032889|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617043|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617044|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617045|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617046|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617047|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617048|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617049|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617050|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617051|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617052|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617054|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617055|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617056|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617057|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617058|NCT01032889|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617059|NCT01032889|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617060|NCT01032889|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
617061|NCT01032915|B5|Baseline|Total|Total of all reporting groups
617062|NCT01032915|B4|Baseline|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
617063|NCT01032915|B3|Baseline|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
617064|NCT01032915|B2|Baseline|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
617065|NCT01032915|B1|Baseline|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
617066|NCT01032915|P4|Participant Flow|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
617067|NCT01032915|P3|Participant Flow|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
617068|NCT01032915|P2|Participant Flow|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
617069|NCT01032915|P1|Participant Flow|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
617070|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
617071|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
617072|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
617073|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
617074|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
617077|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
617078|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
617079|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
617080|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
617081|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
617082|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
617083|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
617084|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
617085|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
617086|NCT01032915|E4|Reported Event|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
617087|NCT01032915|E3|Reported Event|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
617088|NCT01032915|E2|Reported Event|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
617089|NCT01032915|E1|Reported Event|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
617090|NCT01032928|B1|Baseline|Respiratory-Swallow Phase Training|"Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns
Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals."
617091|NCT01032928|P1|Participant Flow|Respiratory - Swallow Phase Training|Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns
617092|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were reassessed at one month post treatment
617093|NCT01032928|O2|Outcome|One Week Post-intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
617094|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
617095|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were assessed at one month following completion of the treatment protocol
617096|NCT01032928|O2|Outcome|One Week Post Intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
617097|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
617098|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were assessed at one month following completion of the treatment protocol
617099|NCT01032928|O2|Outcome|One Week Post Intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
617100|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
617101|NCT01032928|E1|Reported Event|Arm 1|"Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns
Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals."
617102|NCT01032993|B3|Baseline|Total|Total of all reporting groups
617103|NCT01032993|B2|Baseline|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
617104|NCT01032993|B1|Baseline|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
617105|NCT01032993|P2|Participant Flow|Placebo|The Placebo arm used placebo wafers taken as three wafers two times daily for 4 weeks. Placebo wafers contained the same excipients as the active wafers, but contained no active CoQ10. The wafers looked and tasted identical to active agent, and were manufactured by the same manufacturer of the active agent, Tishcon Corp (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily
617106|NCT01032993|P1|Participant Flow|Coenzyme Q10|The Coenzyme Q10 arm used 600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily for 4 weeks. Active study wafers were ChewQ (ubidecarenone) and were manufactured by Tishcon Corp, (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily
617107|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
617108|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
617109|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
617110|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
617111|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
617112|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
617113|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
617114|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
617115|NCT01032993|E2|Reported Event|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
617116|NCT01032993|E1|Reported Event|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
617117|NCT01033019|B3|Baseline|Total|Total of all reporting groups
617118|NCT01033019|B2|Baseline|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
617119|NCT01033019|B1|Baseline|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
617120|NCT01033019|P2|Participant Flow|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
617121|NCT01033019|P1|Participant Flow|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
617122|NCT01033019|O2|Outcome|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
617123|NCT01033019|O1|Outcome|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
617124|NCT01033019|E3|Reported Event|LDE225 0.75% - nBCC|
617125|NCT01033019|E2|Reported Event|Vehicle - sBCC|Participants topically applied matching placebo cream twice daily for 6 weeks.
617126|NCT01033019|E1|Reported Event|LDE225 0.75% - sBCC|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
617127|NCT01033032|B1|Baseline|All Patients|Includes all Phase I and Phase II patients treated at all dose levels (total enrollment = 78 patients)
617128|NCT01033032|P4|Participant Flow|Dose Level 4|Amrubicin - 120 mg/m^2 every 21 days
617129|NCT01033032|P3|Participant Flow|Dose Level 3|Amrubicin - 110 mg/m^2 IV every 21 days
617130|NCT01033032|P2|Participant Flow|Dose Level 2|Amrubicin - 100 mg/m^2 IV every 21 days
617131|NCT01033032|P1|Participant Flow|Dose Level 1|Amrubicin - 90 mg/m^2 by intravenous (IV) every 21 days
617132|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
617133|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
617134|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
617135|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
617136|NCT01033032|E1|Reported Event|Dose Level 3|Includes patients treated at the MTD (Dose Level 3)
617137|NCT01033071|B4|Baseline|Total|Total of all reporting groups
617138|NCT01033071|B3|Baseline|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617139|NCT01033071|B2|Baseline|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617140|NCT01033071|B1|Baseline|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617271|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
617272|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617273|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617141|NCT01033071|P3|Participant Flow|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617142|NCT01033071|P2|Participant Flow|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617143|NCT01033071|P1|Participant Flow|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617144|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617145|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617146|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617219|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs"
617220|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd
2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
617391|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617147|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617148|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617149|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617150|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617151|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617274|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
618942|NCT01037218|O4|Outcome|Placebo|Placebo tablets
617152|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617153|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617154|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617155|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617156|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617157|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617158|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617254|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617159|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617160|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617161|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617162|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617163|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617164|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617165|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617166|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617167|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617168|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617169|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617170|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617255|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
617171|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617172|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617173|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617174|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617175|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617176|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617177|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617178|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617179|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617180|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617181|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617182|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617256|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
617183|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617184|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617185|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617186|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617187|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617188|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617189|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617190|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617191|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617192|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617193|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617194|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617257|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
617195|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617196|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617197|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617198|NCT01033071|E3|Reported Event|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
617199|NCT01033071|E2|Reported Event|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617200|NCT01033071|E1|Reported Event|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
617201|NCT01033227|B3|Baseline|Total|Total of all reporting groups
617202|NCT01033227|B2|Baseline|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP
sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
617203|NCT01033227|B1|Baseline|No Drug|
617204|NCT01033227|P2|Participant Flow|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP
sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
617205|NCT01033227|P1|Participant Flow|No Drug|This group did not receive anything additional in the no drug arm. The treatment group received the study drug and the non treatment group received no drug.
617206|NCT01033227|O2|Outcome|Sodium Nitrite Injection, USP|Administration of sodium nitrite injection, USP
617207|NCT01033227|O1|Outcome|No Drug|Will not receive study drug, there is no placebo in this study. The patient will know they are not receiving the study drug.
617208|NCT01033227|E2|Reported Event|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP
sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
617209|NCT01033227|E1|Reported Event|No Drug|This group received no study drug and no placebo. They received standard of care treatment.
617210|NCT01033383|B5|Baseline|Total|Total of all reporting groups
617211|NCT01033383|B4|Baseline|3 Cranberry Capsules|"3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs"
617212|NCT01033383|B3|Baseline|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd
2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
617213|NCT01033383|B2|Baseline|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd
1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
617214|NCT01033383|B1|Baseline|3 Placebo Capsules|"3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs"
617215|NCT01033383|P4|Participant Flow|3 Cranberry Capsules|"3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs"
617216|NCT01033383|P3|Participant Flow|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd
2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
617217|NCT01033383|P2|Participant Flow|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd
1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
617218|NCT01033383|P1|Participant Flow|3 Placebo Capsules|"3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs"
617221|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd
1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
617222|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs"
617223|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs"
617224|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd
2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
617225|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd
1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
617226|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs"
617227|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs"
617228|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd
2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
617229|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd
1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
617230|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs"
617231|NCT01033383|E4|Reported Event|3 Cranberry Capsules|"3 active cranberry capsules qd
3 cranberry capsules : 3 36mg cranberry capsules qhs"
617232|NCT01033383|E3|Reported Event|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd
2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
617233|NCT01033383|E2|Reported Event|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd
1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
617234|NCT01033383|E1|Reported Event|3 Placebo Capsules|"3 placebo capsules qd
Placebo : Three placebo capsules, each 36mg, qhs"
617275|NCT01033487|O2|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617276|NCT01033487|O1|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
618943|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
617235|NCT01033487|B1|Baseline|Entire Study Population|Includes all participants randomized to receive PBO Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 180 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 580 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 1450 mcg dry powder first, Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first.
617236|NCT01033487|P10|Participant Flow|PF-03635659 580,PF-03635659 180,PF-03635659 1450,PBO,Spiriva18|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
617237|NCT01033487|P9|Participant Flow|PF-03635659 180,PBO,PF-03635659 580,Spiriva18,PF-03635659 1450|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
617238|NCT01033487|P8|Participant Flow|PBO,Spiriva18,PF-03635659 180,PF-03635659 1450,PF-03635659 580|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
617239|NCT01033487|P7|Participant Flow|Spiriva18,PF-03635659 1450,PBO,PF-03635659 580,PF-03635659 180|Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
617258|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617240|NCT01033487|P6|Participant Flow|PF-03635659 1450,PF-03635659 580,Spiriva18,PF-03635659 180,PBO|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva (tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium)18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated byat least 7 days.
617241|NCT01033487|P5|Participant Flow|Spiriva18,PBO,PF-03635659 1450,PF-03635659 180,PF-03635659 580|Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
617277|NCT01033487|O2|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617278|NCT01033487|O1|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617279|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617280|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617242|NCT01033487|P4|Participant Flow|PF-03635659 1450,Spiriva18,PF-03635659 580,PBO,PF-03635659 180|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period,single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(Tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
617243|NCT01033487|P3|Participant Flow|PF-03635659 580,PF-03635659 1450,PF-03635659 180,Spiriva18,PBO|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
617244|NCT01033487|P2|Participant Flow|PF-03635659 180,PF-03635659 580,PBO,PF-03635659 1450,Spiriva18|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period,single oral inhalation dose of placebo matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
617245|NCT01033487|P1|Participant Flow|PBO,PF-03635659 180,Spiriva18,PF-03635659 580,PF-03635659 1450|Single oral inhalation dose of placebo (PBO) matched with Spiriva(tiotropium) 18 microgram (mcg) capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
617246|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
617247|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
617248|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617249|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617250|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
617251|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
617252|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
617253|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617259|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617260|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
617261|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
617262|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
617263|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617264|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617265|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
617266|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617267|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617268|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
617269|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617270|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
618944|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
617282|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617283|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617284|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
617285|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617286|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617287|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
617288|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
617289|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
617290|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617291|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617292|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
617293|NCT01033487|E5|Reported Event|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
617294|NCT01033487|E4|Reported Event|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
617295|NCT01033487|E3|Reported Event|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
617296|NCT01033487|E2|Reported Event|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
617297|NCT01033487|E1|Reported Event|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
617298|NCT01033565|B1|Baseline|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days
Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
617299|NCT01033565|P1|Participant Flow|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days
Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
617300|NCT01033565|O1|Outcome|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days
Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
617301|NCT01033565|E1|Reported Event|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days
Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
617302|NCT01033734|B1|Baseline|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight ≤23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617303|NCT01033734|P1|Participant Flow|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to (≤) 23 kilogram (kg) received 3 milligrams per kilogram (mg/kg); participants with body weight more than (>) 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 milligrams (mg). For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617304|NCT01033734|O4|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617305|NCT01033734|O3|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617306|NCT01033734|O2|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617360|NCT01033747|O1|Outcome|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
617307|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617308|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617309|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617310|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617311|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617312|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617377|NCT01033825|P3|Participant Flow|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617313|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617314|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617315|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617316|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617361|NCT01033747|O2|Outcome|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
617421|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617317|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617318|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617319|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617320|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617321|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617322|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617378|NCT01033825|P2|Participant Flow|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617379|NCT01033825|P1|Participant Flow|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617380|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617323|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617324|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617325|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617326|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617327|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617328|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617329|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617330|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617331|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617332|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617381|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617382|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617383|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617333|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617334|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617335|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617336|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617337|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617338|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617339|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617340|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617341|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617342|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617384|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617385|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617386|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617343|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617344|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617345|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617346|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617347|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617348|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617349|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617350|NCT01033734|E4|Reported Event|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617351|NCT01033734|E3|Reported Event|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617352|NCT01033734|E2|Reported Event|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617387|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617388|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617389|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617390|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617353|NCT01033734|E1|Reported Event|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
617354|NCT01033747|B3|Baseline|Total|Total of all reporting groups
617355|NCT01033747|B2|Baseline|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
617356|NCT01033747|B1|Baseline|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
617357|NCT01033747|P2|Participant Flow|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
617358|NCT01033747|P1|Participant Flow|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
617359|NCT01033747|O2|Outcome|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
617419|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617420|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617362|NCT01033747|O1|Outcome|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
617363|NCT01033747|E2|Reported Event|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg/kg to 30 mg/kg deferasirox orally daily at the beginning of the 5-year non-comparative extension study.
617364|NCT01033747|E1|Reported Event|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on the same deferasirox treatment during the comparative prolongation study(NCT00379483)and at the beginning of the 5-year non-comparative extension study
617365|NCT01033825|B8|Baseline|Total|Total of all reporting groups
617366|NCT01033825|B7|Baseline|Placebo AQ Plus Dexamethasone 6 mg|Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
617367|NCT01033825|B6|Baseline|Placebo HFA Plus Dexamethasone 6 mg|Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
617368|NCT01033825|B5|Baseline|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617369|NCT01033825|B4|Baseline|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617370|NCT01033825|B3|Baseline|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617371|NCT01033825|B2|Baseline|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617372|NCT01033825|B1|Baseline|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617373|NCT01033825|P7|Participant Flow|Placebo AQ Plus Dexamethasone 6 mg|Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
617374|NCT01033825|P6|Participant Flow|Placebo HFA Plus Dexamethasone 6 mg|Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
617375|NCT01033825|P5|Participant Flow|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617376|NCT01033825|P4|Participant Flow|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617393|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617394|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617395|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617396|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617397|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617398|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617399|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617400|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617401|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617402|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617403|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617404|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617405|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617406|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617407|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617408|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617409|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617410|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617411|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617412|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617413|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617414|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617415|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617416|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617417|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617418|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617422|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617423|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617424|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617425|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617426|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617427|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617428|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617429|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617430|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617431|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617432|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617433|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617434|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617435|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617436|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617437|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617438|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617439|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617440|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617441|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617442|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617443|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
617444|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily
617445|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617446|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617447|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily
617448|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617449|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617450|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617451|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617452|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617453|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617454|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617455|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617456|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617457|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617458|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617459|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617460|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617461|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617462|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617463|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617464|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617465|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617466|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617467|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617468|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617469|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617470|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617471|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617472|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617473|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617474|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617475|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617476|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617477|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617478|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617479|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617480|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617481|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617482|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617483|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617484|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617485|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617486|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617487|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617488|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617489|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617490|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617491|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617492|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617493|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617494|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617495|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617496|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617497|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617498|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617499|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617500|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617501|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617502|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617503|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617504|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617505|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617506|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617507|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617508|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617509|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617510|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
627958|NCT01059760|O1|Outcome|Baseline Value|
617511|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617512|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617513|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617514|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617515|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617516|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617517|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617518|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617519|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617520|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617521|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617522|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617523|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617524|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617525|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617526|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617527|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617528|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617529|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617530|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617531|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617532|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617533|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617534|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617535|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617536|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617537|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617538|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617539|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617541|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617542|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617543|NCT01033825|O7|Outcome|Placebo AQ Plus 6 mg Dexamethasone|Placebo AQ plus 6 mg Dexamethasone once daily
617544|NCT01033825|O6|Outcome|Placebo HFA Plus 6 mg Dexamethasone|Placebo HFA plus 6 mg Dexamethasone once daily
617545|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617546|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617547|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617548|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617549|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617550|NCT01033825|O7|Outcome|Placebo AQ Plus 6 mg Dexamethasone|Placebo AQ plus 6 mg Dexamethasone once daily
617551|NCT01033825|O6|Outcome|Placebo HFA Plus 6 mg Dexamethasone|Placebo HFA plus 6 mg Dexamethasone once daily
617552|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617553|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617554|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617555|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617556|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617557|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617558|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617559|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617560|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617561|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617562|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617563|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617564|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617565|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617566|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617567|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617568|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617569|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617570|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617571|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617572|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617573|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617574|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617575|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617576|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617577|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617578|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617579|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617580|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617581|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617582|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
617583|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617584|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617585|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617586|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617587|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
617588|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily
617589|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617590|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617591|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily
617592|NCT01033825|E5|Reported Event|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
617593|NCT01033825|E4|Reported Event|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
617594|NCT01033825|E3|Reported Event|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
617595|NCT01033825|E2|Reported Event|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
617596|NCT01033825|E1|Reported Event|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
617597|NCT01033851|B3|Baseline|Total|Total of all reporting groups
617598|NCT01033851|B2|Baseline|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
617599|NCT01033851|B1|Baseline|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
617600|NCT01033851|P2|Participant Flow|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
617601|NCT01033851|P1|Participant Flow|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
617602|NCT01033851|O2|Outcome|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
617603|NCT01033851|O1|Outcome|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
617604|NCT01033851|O2|Outcome|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
617605|NCT01033851|O1|Outcome|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
617606|NCT01033851|E2|Reported Event|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
617607|NCT01033851|E1|Reported Event|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
617608|NCT01033864|B3|Baseline|Total|Total of all reporting groups
617609|NCT01033864|B2|Baseline|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617610|NCT01033864|B1|Baseline|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617611|NCT01033864|P2|Participant Flow|Enteric-coated Mycophenolate Sodium (EC-MPS)/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617612|NCT01033864|P1|Participant Flow|Mycophenolate Mofetil (MMF)/Prednisone|Participants were administered MMF tablets or capsules, orally (PO), at a dose prescribed by their physician and prednisone up to 5 milligrams (mg) PO on Day 1.
617613|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617614|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617615|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617616|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617617|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617618|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617619|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617620|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
627959|NCT01059760|O3|Outcome|Change When Fed|
617621|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617622|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617623|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617624|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617625|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617626|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617627|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617628|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617629|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617630|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617631|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617632|NCT01033864|E2|Reported Event|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617633|NCT01033864|E1|Reported Event|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
617634|NCT01033942|B4|Baseline|Total|Total of all reporting groups
617635|NCT01033942|B3|Baseline|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617636|NCT01033942|B2|Baseline|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617780|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
618945|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
617637|NCT01033942|B1|Baseline|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617638|NCT01033942|P3|Participant Flow|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617639|NCT01033942|P2|Participant Flow|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617640|NCT01033942|P1|Participant Flow|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617641|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617642|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617643|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617644|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617645|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617646|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617647|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617648|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617649|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617650|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617651|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617652|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617653|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617654|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617949|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618946|NCT01037218|O4|Outcome|Placebo|Placebo tablets
617655|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617656|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617657|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617658|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617659|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617660|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617661|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617662|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617663|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617664|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617665|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
618233|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
617666|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617667|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617668|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617669|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617670|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617671|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617672|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
618240|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
618241|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
617673|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617674|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617675|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617676|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617677|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617678|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617679|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617680|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617681|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617682|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617683|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617684|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617685|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617686|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617687|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617688|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617689|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617690|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617804|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617691|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617692|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617693|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617694|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617695|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617696|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617697|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617698|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617699|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617700|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617701|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617702|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617795|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617703|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617704|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617705|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617706|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617707|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617708|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617709|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617710|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617711|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617712|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617713|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617714|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617715|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617716|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617717|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617718|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617719|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617720|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617871|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
618234|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
617721|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617722|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617723|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617724|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617725|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617726|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617727|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617728|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617729|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617730|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617731|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617732|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617733|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617734|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617735|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617736|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617737|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617738|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617872|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617739|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617740|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617741|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617742|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617743|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617744|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617745|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617746|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617747|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617748|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617749|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617750|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617751|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617752|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617753|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617754|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617755|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617756|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617933|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617757|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617758|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617759|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617760|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617761|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617762|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617763|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617764|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617765|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617766|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617767|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617768|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617769|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617770|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617771|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617772|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617773|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617934|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617774|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617775|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617776|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617777|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617778|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617779|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617781|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617782|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617783|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617784|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617785|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617786|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617787|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617788|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617789|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617790|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617791|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617792|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617793|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
627960|NCT01059760|O2|Outcome|Change While Fasting|
617796|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617797|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617798|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617799|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617800|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617801|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617802|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617803|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
618242|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
617805|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617806|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617807|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617808|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617809|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617810|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617811|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617812|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617813|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617814|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617815|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617816|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617935|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617817|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617818|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617819|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617820|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617821|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617822|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617823|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617824|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617825|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617826|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617827|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617828|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617829|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617830|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617831|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617832|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617833|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617834|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617835|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617836|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
617837|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617936|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617838|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617839|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617840|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617841|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617842|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617843|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617917|NCT01034137|B1|Baseline|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617844|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617845|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617846|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617847|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617848|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617849|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617850|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617851|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617852|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617853|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617937|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617854|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617855|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617856|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617857|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617858|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617859|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617860|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617861|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617862|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617863|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617864|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617865|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617866|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617867|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617868|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617869|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617870|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
618235|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
617873|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617874|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617875|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617876|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617877|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617878|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617918|NCT01034137|P3|Participant Flow|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617879|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617880|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617881|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617882|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617883|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617884|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617885|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617886|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617887|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617888|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617889|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617890|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617938|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617891|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617892|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617893|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617894|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617895|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
618243|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
617896|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617897|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617898|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617899|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617900|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617901|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617902|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617903|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617904|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617905|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617906|NCT01033942|E3|Reported Event|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617907|NCT01033942|E2|Reported Event|Placebo|"Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617939|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617908|NCT01033942|E1|Reported Event|FTC/TDC|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
617909|NCT01034111|B1|Baseline|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
617910|NCT01034111|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
617911|NCT01034111|O1|Outcome|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
617912|NCT01034111|O1|Outcome|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
617913|NCT01034111|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
617914|NCT01034137|B4|Baseline|Total|Total of all reporting groups
617915|NCT01034137|B3|Baseline|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617916|NCT01034137|B2|Baseline|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617919|NCT01034137|P2|Participant Flow|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617920|NCT01034137|P1|Participant Flow|Tocilizumab + Methotrexate|Participants received intravenous (IV) Tocilizumab (TCZ) 8 milligram (mg)/kilogram (kg) every four weeks for a maximum of 26 infusions + oral capsules of Methotrexate (MTX) 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617921|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617922|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617923|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617924|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617925|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617926|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617927|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617928|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617929|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617930|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617931|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617932|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618061|NCT01034176|B1|Baseline|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
levofloxacin: 500 mg tablet, daily, 30 days"
617940|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617941|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617942|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617943|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617944|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617945|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617946|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617947|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617948|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617950|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617951|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617952|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617953|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617954|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617955|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617956|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617957|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617958|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617959|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617960|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617961|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618006|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617962|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617963|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617964|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617965|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617966|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617967|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617968|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617969|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617970|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618244|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
618245|NCT01027650|E8|Reported Event|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
618947|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
617971|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617972|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617973|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617974|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617975|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617976|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617977|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617978|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617979|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617980|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617981|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617982|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617983|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618055|NCT01034163|O2|Outcome|Placebo|Participants received matching placebo to PAN TIW, QOW.
618056|NCT01034163|O1|Outcome|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
617984|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617985|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617986|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617987|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617988|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617989|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617990|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617991|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617992|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617993|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617994|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617995|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617996|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
617997|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
617998|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
617999|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618000|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618001|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618002|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618003|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618004|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618005|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618057|NCT01034163|E2|Reported Event|Placebo|Participants received matching placebo to PAN TIW, QOW.
618058|NCT01034163|E1|Reported Event|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
618007|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618008|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618009|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618010|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618011|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618012|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618013|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618014|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618015|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618016|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618017|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618018|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618019|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618020|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618021|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618022|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618023|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618024|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618025|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618026|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618027|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618028|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618059|NCT01034176|B3|Baseline|Total|Total of all reporting groups
618060|NCT01034176|B2|Baseline|Placebo|"placebo identical to levofloxacin drug daily for 30 days
placebo: no dose, tablet, daily, 30 days"
618029|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618030|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618031|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618032|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week
618033|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618034|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618035|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618036|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618037|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618038|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618039|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618040|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618041|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618042|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618043|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618044|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618045|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618046|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618047|NCT01034137|E3|Reported Event|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
618048|NCT01034137|E2|Reported Event|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
618049|NCT01034137|E1|Reported Event|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
618050|NCT01034163|B3|Baseline|Total|Total of all reporting groups
618051|NCT01034163|B2|Baseline|Placebo|Participants received matching placebo to PAN TIW, QOW.
618052|NCT01034163|B1|Baseline|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
618053|NCT01034163|P2|Participant Flow|Placebo|Participants received matching placebo to PAN TIW, QOW.
618054|NCT01034163|P1|Participant Flow|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
618062|NCT01034176|P2|Participant Flow|Placebo|"placebo identical to levofloxacin drug daily for 30 days
placebo: no dose, tablet, daily, 30 days"
618063|NCT01034176|P1|Participant Flow|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
levofloxacin: 500 mg tablet, daily, 30 days"
618064|NCT01034176|O2|Outcome|Placebo|"placebo identical to levofloxacin drug daily for 30 days
placebo: no dose, tablet, daily, 30 days"
618065|NCT01034176|O1|Outcome|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
levofloxacin: 500 mg tablet, daily, 30 days"
618066|NCT01034176|O2|Outcome|Placebo|"placebo identical to levofloxacin drug daily for 30 days
placebo: no dose, tablet, daily, 30 days"
618067|NCT01034176|O1|Outcome|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
levofloxacin: 500 mg tablet, daily, 30 days"
618068|NCT01034176|E2|Reported Event|Placebo|"placebo identical to levofloxacin drug daily for 30 days
placebo: no dose, tablet, daily, 30 days"
618069|NCT01034176|E1|Reported Event|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
levofloxacin: 500 mg tablet, daily, 30 days"
618070|NCT01034306|B3|Baseline|Total|Total of all reporting groups
618071|NCT01034306|B2|Baseline|Placebo|MAtching placebo q12 for 12 weeks
618072|NCT01034306|B1|Baseline|CF101 1mg|CF101 1mg q12 for 12 weeks
618073|NCT01034306|P2|Participant Flow|Placebo|Matching placebo q12 for 12 weeks
618074|NCT01034306|P1|Participant Flow|CF101 1mg|CF101 1mg q12 for 12 weeks
618075|NCT01034306|O2|Outcome|Placebo|Matching placebo q12 for 12 weeks
618076|NCT01034306|O1|Outcome|CF101 1mg|CF101 1mg q12 for 12 weeks
618077|NCT01034306|E2|Reported Event|Placebo|Matching placebo q12 for 12 weeks
618078|NCT01034306|E1|Reported Event|CF101 1mg|CF101 1mg q12 for 12 weeks
618079|NCT01034358|B1|Baseline|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
618080|NCT01034358|P1|Participant Flow|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
618081|NCT01034358|O1|Outcome|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
618082|NCT01034358|E1|Reported Event|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
618083|NCT01027364|B5|Baseline|Total|Total of all reporting groups
618084|NCT01027364|B4|Baseline|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
618085|NCT01027364|B3|Baseline|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618086|NCT01027364|B2|Baseline|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618087|NCT01027364|B1|Baseline|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618088|NCT01027364|P4|Participant Flow|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
618089|NCT01027364|P3|Participant Flow|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618090|NCT01027364|P2|Participant Flow|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618091|NCT01027364|P1|Participant Flow|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618092|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618236|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
618093|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618094|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618095|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618096|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618246|NCT01027650|E7|Reported Event|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
618247|NCT01027650|E6|Reported Event|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
618248|NCT01027650|E5|Reported Event|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
618249|NCT01027650|E4|Reported Event|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
618250|NCT01027650|E3|Reported Event|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
618251|NCT01027650|E2|Reported Event|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
618252|NCT01027650|E1|Reported Event|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
618097|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618098|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618099|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618100|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618101|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618129|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
618237|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
618238|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
618102|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618103|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618253|NCT01027780|B3|Baseline|Total|Total of all reporting groups
618948|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
618104|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618105|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618106|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618107|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618108|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618130|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
618131|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Child and adolescent participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
618239|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
618109|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618110|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618111|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618254|NCT01027780|B2|Baseline|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
618949|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
618112|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618113|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618114|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618115|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618116|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618132|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Child and adolescent participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
618133|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
618134|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
618135|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
618117|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618255|NCT01027780|B1|Baseline|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
618256|NCT01027780|P2|Participant Flow|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
618257|NCT01027780|P1|Participant Flow|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
618118|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618119|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618120|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.
All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
618121|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
618122|NCT01027364|O5|Outcome|Total|All participants from Arms 1-4
618123|NCT01027364|O4|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
618124|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618125|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618126|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618127|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
618128|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
618219|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
618136|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
618137|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618138|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618139|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618140|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618141|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618142|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618143|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618144|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618145|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618146|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618147|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618148|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618149|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618220|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
618221|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
618222|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
627961|NCT01059760|O1|Outcome|Baseline Value|
618150|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618258|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
618259|NCT01027780|O1|Outcome|Mindfulness Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
618950|NCT01037218|O4|Outcome|Placebo|Placebo tablets
618151|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618152|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618153|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618154|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618155|NCT01027364|O1|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618156|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618157|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618158|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618159|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618160|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618161|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618223|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
618224|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
618225|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
618226|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
618227|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
618228|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
618260|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
618261|NCT01027780|O1|Outcome|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
618951|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
618162|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618163|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618164|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618165|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618166|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
618167|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
618168|NCT01027364|O5|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
618169|NCT01027364|O4|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618170|NCT01027364|O3|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618171|NCT01027364|O2|Outcome|Arm 1: Weekly Prophylaxis-rFIXFc|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618172|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis-BeneFIX|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618173|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618174|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618229|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
618230|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
618231|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
618175|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618176|NCT01027364|E3|Reported Event|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
618177|NCT01027364|E2|Reported Event|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
618178|NCT01027364|E1|Reported Event|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.
Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
618179|NCT01027468|B1|Baseline|Group 1|3 year follow-up of intravitreal application of bevacizumab
618180|NCT01027468|P1|Participant Flow|Group 1|3 year follow-up of patients with intravitreal application of bevacizumab
618181|NCT01027468|O1|Outcome|Group 1|3 year follow-up of intravitreal application of bevacizumab
618182|NCT01027468|E1|Reported Event|Group 1|3 year follow-up of intravitreal application of bevacizumab
618183|NCT01027598|B3|Baseline|Total|Total of all reporting groups
618184|NCT01027598|B2|Baseline|Arm B|"Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily"
618185|NCT01027598|B1|Baseline|Arm A|"Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily"
618186|NCT01027598|P2|Participant Flow|Erlotinib + Placebo|"Erlotinib: 150 mg orally daily
Placebo: orally daily"
618187|NCT01027598|P1|Participant Flow|Erlotinib + Pazopanib|"Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily"
618188|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily"
618189|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily"
618190|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily"
618191|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily"
618192|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily"
618193|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily"
618194|NCT01027598|E2|Reported Event|Arm B|"Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily"
618195|NCT01027598|E1|Reported Event|Arm A|"Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily"
618196|NCT01027650|B9|Baseline|Total|Total of all reporting groups
618197|NCT01027650|B8|Baseline|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
618198|NCT01027650|B7|Baseline|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
618199|NCT01027650|B6|Baseline|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
618200|NCT01027650|B5|Baseline|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
618201|NCT01027650|B4|Baseline|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
618202|NCT01027650|B3|Baseline|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
618203|NCT01027650|B2|Baseline|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
618204|NCT01027650|B1|Baseline|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
618205|NCT01027650|P8|Participant Flow|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
618206|NCT01027650|P7|Participant Flow|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
618207|NCT01027650|P6|Participant Flow|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
618208|NCT01027650|P5|Participant Flow|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
618209|NCT01027650|P4|Participant Flow|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
618210|NCT01027650|P3|Participant Flow|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
618211|NCT01027650|P2|Participant Flow|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
618212|NCT01027650|P1|Participant Flow|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
618213|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
618214|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
618215|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
618216|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
618217|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
618218|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
618262|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
618263|NCT01027780|O1|Outcome|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
618264|NCT01027780|E2|Reported Event|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
618265|NCT01027780|E1|Reported Event|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
618266|NCT01027819|B3|Baseline|Total|Total of all reporting groups
618267|NCT01027819|B2|Baseline|Fixed Bearing|Mobile bearing vs Fixed bearing
618268|NCT01027819|B1|Baseline|Mobile Bearing|Mobile bearing vs Fixed bearing
618269|NCT01027819|P2|Participant Flow|Fixed Bearing|Mobile bearing vs Fixed bearing
618270|NCT01027819|P1|Participant Flow|Mobile Bearing|Mobile bearing vs Fixed bearing
618271|NCT01027819|O2|Outcome|Fixed Bearing|Mobile bearing vs Fixed bearing
618272|NCT01027819|O1|Outcome|Mobile Bearing|Mobile bearing vs Fixed bearing
618273|NCT01027819|E2|Reported Event|Fixed Bearing|Mobile bearing vs Fixed bearing
618274|NCT01027819|E1|Reported Event|Mobile Bearing|Mobile bearing vs Fixed bearing
618275|NCT01034397|B3|Baseline|Total|Total of all reporting groups
618276|NCT01034397|B2|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 24 weeks.
618277|NCT01034397|B1|Baseline|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks through Week 24.
618278|NCT01034397|P2|Participant Flow|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of greater than or equal to [≥]20 percent [%] in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks through Week 24.
618279|NCT01034397|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) intravenously (IV) once every 4 weeks for 24 weeks.
618280|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618281|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618282|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618283|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618284|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618285|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618286|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618287|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618288|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618289|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618290|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618291|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618292|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618293|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618294|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618295|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618296|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618297|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618298|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618299|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618300|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.
618301|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618302|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618303|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618304|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618305|NCT01034397|O3|Outcome|Placebo-Tocilizumab|At 12 Weeks participants who did not show an improvement of ≥20% in tender and swollen joint counts were offered a rescue therapy with open-label tocilizumab 8mg/kg every 4 weeks
618306|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of at least 20% in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks.
618307|NCT01034397|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 24 weeks
618308|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618309|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618310|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618311|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
627962|NCT01059760|O3|Outcome|Change When Fed|
618312|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618313|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618314|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618315|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618316|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618317|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618318|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618319|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618320|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618321|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618322|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618323|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618324|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618325|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618326|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618327|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618328|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618329|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618330|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618331|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618332|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618333|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618334|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618335|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618336|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618337|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618338|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618339|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618340|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618341|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618342|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618343|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618344|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618345|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618346|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618347|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618348|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618349|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618350|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618351|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618352|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618353|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618354|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for a 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618355|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618356|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618357|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618358|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618359|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618360|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618361|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618362|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618363|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618364|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618365|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618366|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618367|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618368|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618369|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618517|NCT01034631|E2|Reported Event|Phase II: Arm A|Phase II Participants, Arm A
618370|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618371|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618372|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618373|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618374|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618375|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618376|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618377|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618378|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618379|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618380|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618381|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618382|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618383|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618384|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618385|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618386|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618387|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618388|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618389|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618390|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618391|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618392|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618393|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618394|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618395|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618396|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618397|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
627963|NCT01059760|O2|Outcome|Change While Fasting|
618398|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618399|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618400|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618401|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618402|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618403|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618404|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618405|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618406|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618407|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618408|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618409|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618443|NCT01034540|O2|Outcome|Prescription Omega-3 Acid Ethyl Esters|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Treatment period I was the average of values at weeks 4 and 6; treatment period II was the average of values at weeks 12 and 14.
618410|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618411|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618412|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618413|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618414|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618415|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618416|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
618417|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618418|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618419|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618420|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618421|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618422|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in tender joint count [TJC] and swollen joint count [SJC]) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618423|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618424|NCT01034397|E3|Reported Event|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618425|NCT01034397|E2|Reported Event|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
618426|NCT01034397|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
618427|NCT01034462|B3|Baseline|Total|Total of all reporting groups
618428|NCT01034462|B2|Baseline|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
618429|NCT01034462|B1|Baseline|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
618430|NCT01034462|P2|Participant Flow|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
618431|NCT01034462|P1|Participant Flow|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
618432|NCT01034462|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
618433|NCT01034462|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
618434|NCT01034462|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks
618435|NCT01034462|O1|Outcome|Placebo|"Matching placebo capsules, oral administration, once daily dosing.
Placebo : Matching placebo to be given orally, in capsule form, once daily, for 8 weeks."
618436|NCT01034462|E2|Reported Event|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
618437|NCT01034462|E1|Reported Event|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
618438|NCT01034540|B3|Baseline|Total|Total of all reporting groups
618439|NCT01034540|B2|Baseline|Placebo/Prescription Omega-3 Acid Ethyl Esters (POM3)|Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment
618440|NCT01034540|B1|Baseline|Prescription Omega-3 Acid Ethyl Esters (POM3)/Placebo|POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
618441|NCT01034540|P2|Participant Flow|Placebo/Prescription Omega-3 Acid Ethyl Esters|Placebo (corn oil 4 g/d) for the first six weeks of treatment. Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the second six weeks of treatment
618442|NCT01034540|P1|Participant Flow|Prescription Omega-3 Acid Ethyl Esters/Placebo|Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the first six weeks of treatment. Placebo (corn oil 4 g/d) for the second six weeks of treatment
618952|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
618444|NCT01034540|O1|Outcome|Control|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Treatment period I was the average of values at weeks 4 and 6; treatment period II was the average of values at weeks 12 and 14.
618445|NCT01034540|O2|Outcome|Prescription Omega-3 Acid Ethyl Esters|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
618446|NCT01034540|O1|Outcome|Control|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
618447|NCT01034540|E2|Reported Event|Placebo|Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.
618448|NCT01034540|E1|Reported Event|POM3|Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.
618449|NCT01034553|B1|Baseline|All Patients|"All Patients that received oral aurora A kinase inhibitor MLN8237 and bortezomib IV are summarized in this section.
Aurora A kinase inhibitor MLN8237: Given orally"
618450|NCT01034553|P6|Participant Flow|Phase II, Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
>
> Aurora A kinase inhibitor MLN8237: Given orally
>
> bortezomib: Given IV"
618451|NCT01034553|P5|Participant Flow|Phase I, Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
618452|NCT01034553|P4|Participant Flow|Phase I, Dose 2|"Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
618453|NCT01034553|P3|Participant Flow|Phase I, Dose 1|"Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
618454|NCT01034553|P2|Participant Flow|Phase I, Dose 0|"Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
618455|NCT01034553|P1|Participant Flow|Phase I, Dose 0**|"Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.
Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
618456|NCT01034553|O1|Outcome|All Patients|"Patients receive oral aurora A kinase inhibitor MLN8237 and bortezomib IV. >
> Aurora A kinase inhibitor MLN8237: Given orally
>
> bortezomib: Given IV"
618457|NCT01034553|O1|Outcome|All Patients|"Patients receive oral aurora A kinase inhibitor MLN8237 once daily on days 1-14 and bortezomib IV on days 1, 4, 8 and 11.
>
> Aurora A kinase inhibitor MLN8237: Given orally
>
> bortezomib: Given IV"
618458|NCT01034553|O4|Outcome|Dose Level 3|Patients received 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
618459|NCT01034553|O3|Outcome|Dose Level 2|Patients received 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
618460|NCT01034553|O2|Outcome|Dose Level 1|Patients received 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
618518|NCT01034631|E1|Reported Event|Phase I Participants|Participants in the phase I dose escalation portion of the study.
618461|NCT01034553|O1|Outcome|Dose Level 0|This includes patients who received 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11. As well as, patients who received 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
618462|NCT01034553|O5|Outcome|Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
>
> Aurora A kinase inhibitor MLN8237: Given orally
>
> bortezomib: Given IV"
618463|NCT01034553|O4|Outcome|Dose 2|"Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
>
> Aurora A kinase inhibitor MLN8237: Given orally
>
> bortezomib: Given IV"
618464|NCT01034553|O3|Outcome|Dose 1|"Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
>
> Aurora A kinase inhibitor MLN8237: Given orally
>
> bortezomib: Given IV"
618465|NCT01034553|O2|Outcome|Dose 0|"Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
>
> Aurora A kinase inhibitor MLN8237: Given orally
>
> bortezomib: Given IV"
618466|NCT01034553|O1|Outcome|Dose 0**|"Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.
>
> Aurora A kinase inhibitor MLN8237: Given orally
>
> bortezomib: Given IV"
618467|NCT01034553|E1|Reported Event|All Patients|bortezomib: Given IV
618468|NCT01034579|B3|Baseline|Total|Total of all reporting groups
618469|NCT01034579|B2|Baseline|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618470|NCT01034579|B1|Baseline|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618471|NCT01034579|P2|Participant Flow|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618472|NCT01034579|P1|Participant Flow|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618473|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618474|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618475|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618476|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618477|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618478|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618479|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618480|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618481|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618482|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618483|NCT01034579|E2|Reported Event|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618746|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618747|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618484|NCT01034579|E1|Reported Event|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
618485|NCT01034592|B1|Baseline|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
618486|NCT01034592|P1|Participant Flow|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
618487|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
618488|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
618489|NCT01034592|O1|Outcome|Lenalidomide|"Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
Lenalidomide: 2.5 mg/wk up to 5 mg 3x/wk"
618490|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
618491|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
618492|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
618493|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
618494|NCT01034592|E1|Reported Event|Serious Adverse Events|Serious Adverse Events include: adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.
618495|NCT01034631|B4|Baseline|Total|Total of all reporting groups
618496|NCT01034631|B3|Baseline|Phase II: Arm B Participants|"Phase II: Arm B Participants
Everolimus only, followed by BNC105P monotherapy"
618497|NCT01034631|B2|Baseline|Phase II: Arm A|"Phase II Participants, Arm A
Everolimus + BNC105P"
618498|NCT01034631|B1|Baseline|Phase I Participants|Participants in the phase I dose escalation portion of the study.
618499|NCT01034631|P3|Participant Flow|Phase II: Arm B Participants|"Phase II: Arm B Participants
Everolimus 10mg followed by BNC105P monotherapy (16mg/m^2) following progression or intolerable toxicity on Everolimus therapy."
618500|NCT01034631|P2|Participant Flow|Phase II: Arm A|"Phase II Participants, Arm A
Everolimus 10mg + BNC105P(Phase I MTD)"
618501|NCT01034631|P1|Participant Flow|Phase I Participants|Participants in the phase I dose escalation portion of the study.
618502|NCT01034631|O1|Outcome|Phase II Participants With Sufficient Correlative Samples|A subset of Phase II Participants who had sufficient correlative samples drawn for plasma biomarker analysis.
618503|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m^2"
618504|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m^2"
618505|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m^2"
618506|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m^2"
618507|NCT01034631|O1|Outcome|Arm B Participants Who Crossed Over to BNC105P Monotherapy|After progression on everolimus, 33 participants crossed over to BNC105P monotherapy per protocol.
618508|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m^2"
618509|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m^2"
618510|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
618511|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
618512|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m^2"
618513|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m^2"
618514|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
618515|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
618516|NCT01034631|E3|Reported Event|Phase II: Arm B Participants|Phase II: Arm B Participants
618519|NCT01034657|B1|Baseline|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618520|NCT01034657|P3|Participant Flow|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
618521|NCT01034657|P2|Participant Flow|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618522|NCT01034657|P1|Participant Flow|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618523|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
618524|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618525|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618526|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
618527|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618770|NCT01036438|E2|Reported Event|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
618528|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618529|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
618530|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618531|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618532|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
618533|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618534|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618535|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
618536|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618537|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618538|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618539|NCT01034657|O3|Outcome|Not Randomized|
618540|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618541|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618809|NCT01036724|E2|Reported Event|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
618542|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618543|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
618544|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618545|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618546|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618547|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
618548|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618549|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618953|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
618954|NCT01037218|O4|Outcome|Placebo|Placebo tablets
618550|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618551|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
618552|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618553|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618554|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618555|NCT01034657|E4|Reported Event|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
618556|NCT01034657|E3|Reported Event|LBH589 + ESA - Randomized Phase|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618557|NCT01034657|E2|Reported Event|LBH589 - Randomized Phase|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
618558|NCT01034657|E1|Reported Event|LBH589 - Core Phase|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
618559|NCT01034709|B3|Baseline|Total|Total of all reporting groups
618560|NCT01034709|B2|Baseline|Asymptomatic|Subjects who are serologically negative for CMV IgG
618561|NCT01034709|B1|Baseline|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
618562|NCT01034709|P2|Participant Flow|Asymptomatic|Subjects who are serologically negative for CMV IgG prior to transplantation and do not have any CMV symptoms
618563|NCT01034709|P1|Participant Flow|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
618564|NCT01034709|O2|Outcome|Asymptomatic|Subjects who are serologically negative for CMV IgG
618565|NCT01034709|O1|Outcome|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
618566|NCT01034709|E2|Reported Event|Asymptomatic|Subjects who are serologically negative for CMV IgG
618567|NCT01034709|E1|Reported Event|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
618568|NCT01035788|B3|Baseline|Total|Total of all reporting groups
618569|NCT01035788|B2|Baseline|Cognitive Behavioral Conjoint Therapy Communication Skills|"Psychoeducational Intervention
Psychoeducation (control): This control intervention will provide psychoeducation including the communication content from sessions 1-7 of cognitive behavioral conjoint therapy for PTSD."
618748|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618570|NCT01035788|B1|Baseline|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD
Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD: This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive behavioral conjoint therapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
618571|NCT01035788|P2|Participant Flow|Cognitive Behavioral Conjoint Therapy Communication Skills|Cognitive-Behavioral Conjoint Therapy (CBCT) phases 1-2 communications skills training (no PTSD psychoeducation) offered during a weekend couple retreat followed by two monthly group couple sessions for skills review.
618572|NCT01035788|P1|Participant Flow|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy for PTSD (MB-CBCT) is an adaptation of Cognitive-Behavioral Conjoint Therapy for PTSD (CBCT) that offers CBCT Phases 1 and 2 plus mindfulness training in a couple weekend retreat format, followed by continued use of mindfulness skills in session and for out of session practice during one transition couple therapy session, followed by CBCT Phase 3 couple sessions.
618573|NCT01035788|O2|Outcome|Cognitive Behavioral Conjoint Therapy Communication Skills|"Cognitive-Behavioral Conjoint Therapy for PTSD - Communication Skills
This control intervention will provide communication skills training from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD."
618574|NCT01035788|O1|Outcome|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD
This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive Behavioral ConjointTtherapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
618955|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
618575|NCT01035788|E2|Reported Event|Cognitive Behavioral Conjoint Therapy Communication Skills|"CBCT for PTSD - Communication Skills
CBCT for PTSD - Communication Skills: This control intervention will provide psychoeducation including the communication skills content from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD."
618576|NCT01035788|E1|Reported Event|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD
Mindfulness Based Cognitive Behavioral Conjoint Therapy: This intervention combines Cognitive Behavioral Conjoint Therapy for PTSD and mindfulness skills. Cognitive Behavioral Conjoint Therapy for PTSD includes PTSD psychoeducation, communication skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
618577|NCT01035905|B3|Baseline|Total|Total of all reporting groups
618578|NCT01035905|B2|Baseline|Narafilcon A|Narafilcon A contact lens
618579|NCT01035905|B1|Baseline|Nelfilcon A|Nelfilcon A contact lens
618580|NCT01035905|P2|Participant Flow|Narafilcon A|Narafilcon A contact lens
618581|NCT01035905|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lens
618582|NCT01035905|O2|Outcome|Narafilcon A|Narafilcon A contact lens
618583|NCT01035905|O1|Outcome|Nelfilcon A|Nelfilcon A contact lens
618584|NCT01035905|E2|Reported Event|Narafilcon A|Narafilcon A contact lens
618585|NCT01035905|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lens
618586|NCT01035944|B5|Baseline|Total|Total of all reporting groups
618587|NCT01035944|B4|Baseline|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
618588|NCT01035944|B3|Baseline|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
618589|NCT01035944|B2|Baseline|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
618590|NCT01035944|B1|Baseline|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
618591|NCT01035944|P4|Participant Flow|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
618749|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618750|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618592|NCT01035944|P3|Participant Flow|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
618593|NCT01035944|P2|Participant Flow|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
618594|NCT01035944|P1|Participant Flow|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
618595|NCT01035944|O4|Outcome|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
618611|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
618956|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
618596|NCT01035944|O3|Outcome|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
618597|NCT01035944|O2|Outcome|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
618598|NCT01035944|O1|Outcome|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
618599|NCT01035944|E4|Reported Event|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
618600|NCT01035944|E3|Reported Event|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
618601|NCT01035944|E2|Reported Event|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
618602|NCT01035944|E1|Reported Event|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
618603|NCT01036009|B3|Baseline|Total|Total of all reporting groups
618604|NCT01036009|B2|Baseline|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.
Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
618605|NCT01036009|B1|Baseline|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
618606|NCT01036009|P2|Participant Flow|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.
Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
618751|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618607|NCT01036009|P1|Participant Flow|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
618608|NCT01036009|O1|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.
Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
618609|NCT01036009|O1|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.
Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
618610|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.
Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
618764|NCT01036438|B2|Baseline|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
618957|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
618612|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.
Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
618613|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
618614|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.
Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
618615|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
618616|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.
Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
618617|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
618618|NCT01036009|E2|Reported Event|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.
Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
618619|NCT01036009|E1|Reported Event|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
618620|NCT01036022|B7|Baseline|Total|Total of all reporting groups
618621|NCT01036022|B6|Baseline|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618622|NCT01036022|B5|Baseline|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618623|NCT01036022|B4|Baseline|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618752|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618624|NCT01036022|B3|Baseline|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618625|NCT01036022|B2|Baseline|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618626|NCT01036022|B1|Baseline|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618627|NCT01036022|P6|Participant Flow|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618958|NCT01037218|O4|Outcome|Placebo|Placebo tablets
618628|NCT01036022|P5|Participant Flow|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618629|NCT01036022|P4|Participant Flow|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618630|NCT01036022|P3|Participant Flow|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618631|NCT01036022|P2|Participant Flow|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618632|NCT01036022|P1|Participant Flow|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules three times a day (TID) as directed by the investigator for Week 1 to Week 6. Topical 5-aminosalicylic acid (5-ASA) preparation was used as a rescue therapy.
618633|NCT01036022|O4|Outcome|GSK1399686 300mg|Participants were administered oral dose of GSK1399686 300 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 300 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
618634|NCT01036022|O3|Outcome|GSK1399686 100mg|Participants were administered oral dose of GSK1399686 100 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 100 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
618635|NCT01036022|O2|Outcome|GSK1399686 30mg|Participants were administered oral dose of GSK1399686 30 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 30 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
618636|NCT01036022|O1|Outcome|GSK1399686 10mg|Participants were administered oral dose of GSK1399686 10 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 10 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
618637|NCT01036022|O4|Outcome|GSK1399686 300mg|Participants were administered oral dose of GSK1399686 300 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 300 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
618638|NCT01036022|O3|Outcome|GSK1399686 100mg|Participants were administered oral dose of GSK1399686 100 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 100 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
618639|NCT01036022|O2|Outcome|GSK1399686 30mg|Participants were administered oral dose of GSK1399686 30 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 30 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
618640|NCT01036022|O1|Outcome|GSK1399686 10mg|Participants were administered oral dose of GSK1399686 10 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 10 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
618641|NCT01036022|O4|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618642|NCT01036022|O3|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618643|NCT01036022|O2|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618644|NCT01036022|O1|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618645|NCT01036022|O4|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618646|NCT01036022|O3|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618647|NCT01036022|O2|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618648|NCT01036022|O1|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618649|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618650|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618651|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618652|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618753|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618754|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618653|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618654|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618655|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618656|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618657|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618658|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618659|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618660|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618661|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618662|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618663|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618664|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618665|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618666|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
627964|NCT01059760|O1|Outcome|Baseline Value|
618667|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618668|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618669|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618765|NCT01036438|B1|Baseline|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
618827|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
618670|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618671|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618672|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618673|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618674|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618675|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618676|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618677|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618678|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618679|NCT01036022|O4|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618755|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618756|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618757|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618680|NCT01036022|O3|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618681|NCT01036022|O2|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618682|NCT01036022|O1|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618683|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618684|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618685|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618686|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618687|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618688|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618689|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618690|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618691|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618692|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618758|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618759|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618693|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618694|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618695|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618766|NCT01036438|P2|Participant Flow|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
618696|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618697|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618698|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618699|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618700|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618701|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618702|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618703|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618704|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618705|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618706|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
627965|NCT01059760|O3|Outcome|Change When Fed|
618707|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618708|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618767|NCT01036438|P1|Participant Flow|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
618828|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
618959|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
618709|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618710|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618711|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618712|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618713|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618714|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618715|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618716|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618717|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618718|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618719|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618720|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618721|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618768|NCT01036438|O2|Outcome|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
618769|NCT01036438|O1|Outcome|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
618722|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618723|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618724|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618725|NCT01036022|E6|Reported Event|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618726|NCT01036022|E5|Reported Event|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618727|NCT01036022|E4|Reported Event|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618728|NCT01036022|E3|Reported Event|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618729|NCT01036022|E2|Reported Event|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618730|NCT01036022|E1|Reported Event|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
618731|NCT01036165|B1|Baseline|Subject Disposition|Intent-to-Treat Analysis
618732|NCT01036165|P1|Participant Flow|Subject Disposition|Intent-to-Treat Analysis
618733|NCT01036165|O1|Outcome|Subject Disposition|Intent-to-Treat Analysis
618734|NCT01036165|O1|Outcome|Subject Disposition|Intent-to-Treat Analysis
618735|NCT01036165|E1|Reported Event|Subject Disposition|Intent-to-Treat Analysis
618736|NCT01036321|B3|Baseline|Total|Total of all reporting groups
618737|NCT01036321|B2|Baseline|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618738|NCT01036321|B1|Baseline|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618739|NCT01036321|P2|Participant Flow|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618740|NCT01036321|P1|Participant Flow|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618741|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618742|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618743|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618744|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618745|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618905|NCT01037192|O2|Outcome|Vancomycin Twice Daily|Vancomycin 15 mg/kg IV twice daily
618760|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618761|NCT01036321|E2|Reported Event|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
618762|NCT01036321|E1|Reported Event|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
618763|NCT01036438|B3|Baseline|Total|Total of all reporting groups
618771|NCT01036438|E1|Reported Event|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
618772|NCT01036490|B3|Baseline|Total|Total of all reporting groups
618773|NCT01036490|B2|Baseline|Control|Nutritional counseling alone
618774|NCT01036490|B1|Baseline|Exercise|12-week (3 days per week) program of aerobic and resistance training followed by 40 weeks of a home exercise program plus nutritional counseling
618775|NCT01036490|P2|Participant Flow|Control|Dietary management alone
618776|NCT01036490|P1|Participant Flow|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
618777|NCT01036490|O2|Outcome|Control|Dietary management alone
618778|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
618779|NCT01036490|O2|Outcome|Control|Dietary management alone
618780|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
618781|NCT01036490|O2|Outcome|Control|Dietary management alone
618782|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
618783|NCT01036490|O2|Outcome|Control|Dietary management alone
618784|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
618785|NCT01036490|O2|Outcome|Control|Dietary management alone
618786|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
618787|NCT01036490|O2|Outcome|Control|Dietary management alone
618788|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
618789|NCT01036490|E2|Reported Event|Control|Dietary management alone
618790|NCT01036490|E1|Reported Event|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
618791|NCT01036529|B3|Baseline|Total|Total of all reporting groups
618792|NCT01036529|B2|Baseline|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
618793|NCT01036529|B1|Baseline|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
618794|NCT01036529|P2|Participant Flow|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
618795|NCT01036529|P1|Participant Flow|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulator Intervention
618796|NCT01036529|O2|Outcome|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
618797|NCT01036529|O1|Outcome|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
618798|NCT01036529|E2|Reported Event|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
618799|NCT01036529|E1|Reported Event|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
618800|NCT01036724|B3|Baseline|Total|Total of all reporting groups
618801|NCT01036724|B2|Baseline|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
618802|NCT01036724|B1|Baseline|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
618803|NCT01036724|P2|Participant Flow|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
618804|NCT01036724|P1|Participant Flow|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
618805|NCT01036724|O2|Outcome|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
618806|NCT01036724|O1|Outcome|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
618807|NCT01036724|O2|Outcome|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
618808|NCT01036724|O1|Outcome|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
627966|NCT01059760|O2|Outcome|Change While Fasting|
618810|NCT01036724|E1|Reported Event|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
618811|NCT01036763|B1|Baseline|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
618812|NCT01036763|P1|Participant Flow|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
618813|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
618814|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
618815|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
618816|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
618817|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
618818|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
618819|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
618820|NCT01036763|E1|Reported Event|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
618821|NCT01036802|B3|Baseline|Total|Total of all reporting groups
618822|NCT01036802|B2|Baseline|Placebo|Patients were randomized to placebo
618823|NCT01036802|B1|Baseline|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
618824|NCT01036802|P2|Participant Flow|Placebo|Patients were randomized to placebo
618825|NCT01036802|P1|Participant Flow|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
618826|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
618960|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
618829|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
618830|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
618831|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
618832|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
618833|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
618834|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
618835|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
618836|NCT01036802|O2|Outcome|Placebo|Patients were on placebo
618837|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
618838|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
618839|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
618840|NCT01036802|E2|Reported Event|Placebo|Patients were randomized to placebo
618841|NCT01036802|E1|Reported Event|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
618842|NCT01037088|B1|Baseline|All Participants|All participants who were randomized
618843|NCT01037088|P1|Participant Flow|All Participants|All participants were randomized to a 3 way cross over design and received 3.53% THC, 1.29% THC and placebo cannabis.
618844|NCT01037088|O3|Outcome|Placebo Cannabis|trace THC by weight
618845|NCT01037088|O2|Outcome|Low Dose Cannabis|1.29% THC by weight
618846|NCT01037088|O1|Outcome|Mild Dose Cannabis|3.53% THC by weight
618847|NCT01037088|E3|Reported Event|Placebo Cannabis|0% 9-delta tetrahydrocannabinol by weight
618848|NCT01037088|E2|Reported Event|Low Dose Cannabis|1.29% 9-delta tetrahydrocannabinol by weight
618849|NCT01037088|E1|Reported Event|Mild Dose Cannabis|3.53% 9-delta tetrahydrocannabinol by weight
618850|NCT01037114|B1|Baseline|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618851|NCT01037114|P1|Participant Flow|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618852|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618853|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618854|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618855|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618856|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618857|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618858|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618859|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618961|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
618860|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618861|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618862|NCT01037114|E1|Reported Event|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.
As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
618863|NCT01037127|B3|Baseline|Total|Total of all reporting groups
618864|NCT01037127|B2|Baseline|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618865|NCT01037127|B1|Baseline|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF (v-Raf murine sarcoma viral oncogene homolog B1) inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618866|NCT01037127|P2|Participant Flow|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618877|NCT01037127|O2|Outcome|Participants Without Prior Brain Mets|Participants in this arm were those without prior brain metastasis who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
618878|NCT01037127|O1|Outcome|Participants With Prior Brain Mets|Participants in this arm were those with prior (before the start of this study) brain metastasis who were previously treated with standard therapy but not with BRAF inhibitors received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
618906|NCT01037192|O1|Outcome|Vancomycin Once Daily|Vancomycin 30 mg/kg IV daily
627967|NCT01059760|O1|Outcome|Baseline Value|
618867|NCT01037127|P1|Participant Flow|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib (GSK1120212) 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618868|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618889|NCT01037127|O5|Outcome|Participants With BRAF Mutation V600K|Participants in this arm were those with a positive BRAF mutation at V600K, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
618962|NCT01037218|O4|Outcome|Placebo|Placebo tablets
618963|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
618964|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
618869|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618870|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618871|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618872|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618873|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618874|NCT01037127|O5|Outcome|Participants With BRAF Mutation V600K|Participants in this arm were those with positive BRAF mutation at V600K, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
618875|NCT01037127|O4|Outcome|Paticipants With BRAF Mutation V600E and no Prior Brain Mets|Participants in this arm were those with positive BRAF mutation at V600E but no prior brain metastasis, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
618876|NCT01037127|O3|Outcome|Participants With BRAF Mutation V600E|Participants in this arm were those with positive BRAF mutation at V600E, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
618901|NCT01037192|P2|Participant Flow|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
618990|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
618879|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618880|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618881|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618882|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618883|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618884|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618885|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618886|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618902|NCT01037192|P1|Participant Flow|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
618903|NCT01037192|O2|Outcome|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
618904|NCT01037192|O1|Outcome|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
618887|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618888|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618890|NCT01037127|O4|Outcome|Participants With BRAF Mutation V600E and no Prior Brain Mets|Participants in this arm were those with a positive BRAF mutation at V600E but no prior brain metastasis, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
618891|NCT01037127|O3|Outcome|Participants With BRAF Mutation V600E|Participants in this arm were those with a positive BRAF mutation at V600E, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
618892|NCT01037127|O2|Outcome|Participants Without Prior Brain Mets|Participants in this arm were those without prior brain metastasis, who were previoulsy treated with standard thearpy but not BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
618893|NCT01037127|O1|Outcome|Participants With Prior Brain Mets|Participants in this arm were those with prior (before the start of this study) brain metastasis, who were previously treated with standard therapy but not BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
618894|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618895|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618896|NCT01037127|E2|Reported Event|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618897|NCT01037127|E1|Reported Event|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF (v-Raf murine sarcoma viral oncogene homolog B1) inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
618898|NCT01037192|B3|Baseline|Total|Total of all reporting groups
618899|NCT01037192|B2|Baseline|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
618900|NCT01037192|B1|Baseline|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
618907|NCT01037192|E2|Reported Event|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
618908|NCT01037192|E1|Reported Event|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
618909|NCT01037218|B5|Baseline|Total|Total of all reporting groups
618910|NCT01037218|B4|Baseline|Placebo|Placebo tablets
618911|NCT01037218|B3|Baseline|Udenafil 150mg|Udenafil 150mg tablets
618912|NCT01037218|B2|Baseline|Udenafil 100 mg|Udenafil 100 mg tablets
618913|NCT01037218|B1|Baseline|Udenafil 50 mg|Udenafil 50 mg tablets
618914|NCT01037218|P4|Participant Flow|Placebo|Placebo tablets
618915|NCT01037218|P3|Participant Flow|Udenafil 150mg|Udenafil 150mg tablets
618916|NCT01037218|P2|Participant Flow|Udenafil 100 mg|Udenafil 100 mg tablets
618917|NCT01037218|P1|Participant Flow|Udenafil 50 mg|Udenafil 50 mg tablets
618918|NCT01037218|O4|Outcome|Placebo|Placebo tablets
618919|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
618920|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
618921|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
618922|NCT01037218|O4|Outcome|Placebo|Placebo tablets
618923|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
618924|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
618925|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
618926|NCT01037218|O4|Outcome|Placebo|Placebo tablets
618927|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
618928|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
618929|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
618965|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
618966|NCT01037218|O4|Outcome|Placebo|Placebo tablets
618967|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
618968|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
618969|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
618970|NCT01037218|E4|Reported Event|Placebo|Placebo tablets
618971|NCT01037218|E3|Reported Event|Udenafil 150mg|Udenafil 150mg tablets
618972|NCT01037218|E2|Reported Event|Udenafil 100 mg|Udenafil 100 mg tablets
618973|NCT01037218|E1|Reported Event|Udenafil 50 mg|Udenafil 50 mg tablets
618974|NCT01037244|B5|Baseline|Total|Total of all reporting groups
618975|NCT01037244|B4|Baseline|Placebo|Placebo tablets
618976|NCT01037244|B3|Baseline|Udenafil 150mg|Udenafil 150mg tablets
618977|NCT01037244|B2|Baseline|Udenafil 100 mg|Udenafil 100 mg tablets
618978|NCT01037244|B1|Baseline|Udenafil 50 mg|Udenafil 50 mg tablets
618979|NCT01037244|P4|Participant Flow|Placebo|Placebo tablets
618980|NCT01037244|P3|Participant Flow|Udenafil 150mg|Udenafil 150mg tablets
618981|NCT01037244|P2|Participant Flow|Udenafil 100 mg|Udenafil 100 mg tablets
618982|NCT01037244|P1|Participant Flow|Udenafil 50 mg|Udenafil 50 mg tablets
618983|NCT01037244|O4|Outcome|Placebo|Placebo tablets
618984|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
618985|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
618986|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
618987|NCT01037244|O4|Outcome|Placebo|Placebo tablets
618988|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
618989|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
619037|NCT01037244|E2|Reported Event|Udenafil 100 mg|Udenafil 100 mg tablets
619038|NCT01037244|E1|Reported Event|Udenafil 50 mg|Udenafil 50 mg tablets
619039|NCT01037309|B7|Baseline|Total|Total of all reporting groups
619040|NCT01037309|B6|Baseline|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619041|NCT01037309|B5|Baseline|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619042|NCT01037309|B4|Baseline|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619043|NCT01037309|B3|Baseline|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619044|NCT01037309|B2|Baseline|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619045|NCT01037309|B1|Baseline|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619046|NCT01037309|P9|Participant Flow|Intravenous PRO044 8 mg/kg|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619047|NCT01037309|P8|Participant Flow|Intravenous PRO044 5 mg/kg|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619048|NCT01037309|P7|Participant Flow|Intravenous PRO044 1.5 mg/kg|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619049|NCT01037309|P6|Participant Flow|Subcutaneous PRO044 12 mg/kg|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619050|NCT01037309|P5|Participant Flow|Subcutaneous PRO044 10 mg/kg|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619051|NCT01037309|P4|Participant Flow|Subcutaneous PRO044 8 mg/kg|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619052|NCT01037309|P3|Participant Flow|Subcutaneous PRO044 5 mg/kg|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619053|NCT01037309|P2|Participant Flow|Subcutaneous PRO044 1.5 mg/kg|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619054|NCT01037309|P1|Participant Flow|Subcutaneous PRO044 0.5 mg/kg|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619055|NCT01037309|O9|Outcome|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619056|NCT01037309|O8|Outcome|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619057|NCT01037309|O7|Outcome|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619058|NCT01037309|O6|Outcome|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619059|NCT01037309|O5|Outcome|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619060|NCT01037309|O4|Outcome|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619061|NCT01037309|O3|Outcome|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619062|NCT01037309|O2|Outcome|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619063|NCT01037309|O1|Outcome|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619119|NCT01038323|B4|Baseline|Total|Total of all reporting groups
619064|NCT01037309|O9|Outcome|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619065|NCT01037309|O8|Outcome|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619066|NCT01037309|O7|Outcome|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619067|NCT01037309|O6|Outcome|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619068|NCT01037309|O5|Outcome|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619069|NCT01037309|O4|Outcome|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619070|NCT01037309|O3|Outcome|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619071|NCT01037309|O2|Outcome|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619072|NCT01037309|O1|Outcome|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619073|NCT01037309|E9|Reported Event|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619074|NCT01037309|E8|Reported Event|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619075|NCT01037309|E7|Reported Event|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks"
619076|NCT01037309|E6|Reported Event|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619077|NCT01037309|E5|Reported Event|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619078|NCT01037309|E4|Reported Event|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619079|NCT01037309|E3|Reported Event|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619080|NCT01037309|E2|Reported Event|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619081|NCT01037309|E1|Reported Event|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks"
619082|NCT01037452|B5|Baseline|Total|Total of all reporting groups
619083|NCT01037452|B4|Baseline|Placebo|Placebo, single dose
619084|NCT01037452|B3|Baseline|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
619085|NCT01037452|B2|Baseline|PPI Alone|Lansoprazole 15 mg, single dose
619086|NCT01037452|B1|Baseline|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
619087|NCT01037452|P4|Participant Flow|Placebo|Placebo, single dose
619088|NCT01037452|P3|Participant Flow|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
619089|NCT01037452|P2|Participant Flow|PPI Alone|Lansoprazole 15 mg, single dose
619090|NCT01037452|P1|Participant Flow|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
619091|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
619092|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
619093|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
619094|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
619095|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
619096|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
619097|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
619098|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
619099|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
619100|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
619101|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
619102|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
619103|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
619104|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
619105|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
619106|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
619107|NCT01037452|E4|Reported Event|Placebo|Placebo, single dose
619108|NCT01037452|E3|Reported Event|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
619109|NCT01037452|E2|Reported Event|PPI Alone|Lansoprazole 15 mg, single dose
619110|NCT01037452|E1|Reported Event|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
619111|NCT01038128|B1|Baseline|Memantine|Memantine, 10-40 mg daily
619112|NCT01038128|P1|Participant Flow|Memantine|Memantine, 10-40 mg daily
619113|NCT01038128|O1|Outcome|Baseline Data|Ratings at Baseline and Endpoint.
619114|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
619115|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
619116|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
619117|NCT01038128|O1|Outcome|Memantine|Number of Binge Eating and Purging Episodes at Baseline and Endpoint
619118|NCT01038128|E1|Reported Event|Memantine|Memantine, 10-40 mg daily
619120|NCT01038323|B3|Baseline|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
619121|NCT01038323|B2|Baseline|Milnacipran|Milnacipran (drug) only
619122|NCT01038323|B1|Baseline|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
619123|NCT01038323|P3|Participant Flow|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
619124|NCT01038323|P2|Participant Flow|Milnacipran|Milnacipran (drug) only
619125|NCT01038323|P1|Participant Flow|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
619126|NCT01038323|O3|Outcome|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
619127|NCT01038323|O2|Outcome|Milnacipran|Milnacipran (drug) only
619128|NCT01038323|O1|Outcome|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
619129|NCT01038323|O3|Outcome|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
619130|NCT01038323|O2|Outcome|Milnacipran|Milnacipran (drug) only
619131|NCT01038323|O1|Outcome|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
619132|NCT01038323|O3|Outcome|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
619133|NCT01038323|O2|Outcome|Milnacipran|Milnacipran (drug) only
619134|NCT01038323|O1|Outcome|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
619135|NCT01038323|E3|Reported Event|Cognitive Behavioral Therapy|Cognitive behavioral therapy + placebo
619136|NCT01038323|E2|Reported Event|Milnacipran|milnacipran + education
619137|NCT01038323|E1|Reported Event|Combination|Cognitive behavioral therapy + milnacipran
619138|NCT01038336|B4|Baseline|Total|Total of all reporting groups
619139|NCT01038336|B3|Baseline|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
619140|NCT01038336|B2|Baseline|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)
Hearing Conservation brochure: The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
619141|NCT01038336|B1|Baseline|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)
The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
619142|NCT01038336|P3|Participant Flow|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
619143|NCT01038336|P2|Participant Flow|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)
The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
619144|NCT01038336|P1|Participant Flow|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
619145|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
619146|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)
Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
619147|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
619148|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
619149|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)
Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
619150|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
619151|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
619152|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)
Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
619153|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
619154|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
619155|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)
Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
619156|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
619157|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): Soc amounts to no intervention but participants are allowed to seek information about hearing loss prevention of they want to.
619158|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)
Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
619659|NCT01038869|O1|Outcome|Azelaic Acid 15%|tolerability assessments
619159|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)
The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
619160|NCT01038336|O3|Outcome|Standard of Care|Standard of care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to.
619161|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)
Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
619162|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
619163|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention but participants are allowed to seek information about hearing loss prevention of they want to.
619164|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)
Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
619165|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)
The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
619166|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
619249|NCT01038635|O3|Outcome|5-AZA + 5 Days LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
619167|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)
The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
619168|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
619169|NCT01038336|E3|Reported Event|Standard of Care|Standard of Care (SoC): SoC amounts ot no intervention although participants were allowed to seek information about hearing loss prevention if they wanted to.
619170|NCT01038336|E2|Reported Event|Hearing Conservation Brochure|Hearing Conservation Brochure (HCB). Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
619171|NCT01038336|E1|Reported Event|Multimedia Hearing Loss Prevention Program|Multimedia Hearing Loss Prevention Program (HLPP) is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
619172|NCT01038609|B6|Baseline|Total|Total of all reporting groups
619173|NCT01038609|B5|Baseline|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619174|NCT01038609|B4|Baseline|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619175|NCT01038609|B3|Baseline|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619176|NCT01038609|B2|Baseline|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619177|NCT01038609|B1|Baseline|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619178|NCT01038609|P5|Participant Flow|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619179|NCT01038609|P4|Participant Flow|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619180|NCT01038609|P3|Participant Flow|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619181|NCT01038609|P2|Participant Flow|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619182|NCT01038609|P1|Participant Flow|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619183|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619516|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619184|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619185|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619186|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619187|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619188|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619189|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619190|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619250|NCT01038635|O2|Outcome|5-AZA + 5 Days LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
619191|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619192|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619193|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619194|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619195|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619196|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619197|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619198|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619199|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619200|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619201|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619202|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619203|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619204|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619205|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619236|NCT01038635|P6|Participant Flow|5-AZA + LEN 75 mg for 5 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
619206|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619207|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619208|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619209|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619210|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619211|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619212|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619213|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619214|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619215|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619216|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619217|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619218|NCT01038609|E5|Reported Event|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619219|NCT01038609|E4|Reported Event|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619220|NCT01038609|E3|Reported Event|Morphine Extended Release/Acetaminophen|1 dose of 1 morphine extended release capsule and 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619221|NCT01038609|E2|Reported Event|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
619222|NCT01038609|E1|Reported Event|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
619223|NCT01038635|B10|Baseline|Total|Total of all reporting groups
619224|NCT01038635|B9|Baseline|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
619225|NCT01038635|B8|Baseline|Phase II: 5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
619226|NCT01038635|B7|Baseline|5-AZA + LEN 75 mg for 10 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
619227|NCT01038635|B6|Baseline|5-AZA + LEN 75 mg 5 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
619228|NCT01038635|B5|Baseline|5-AZA + 50 LEN|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
619229|NCT01038635|B4|Baseline|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
619230|NCT01038635|B3|Baseline|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
619231|NCT01038635|B2|Baseline|5-AZA + LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days
619232|NCT01038635|B1|Baseline|5-AZA + LEN 10 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days
619233|NCT01038635|P9|Participant Flow|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
619234|NCT01038635|P8|Participant Flow|Phase II: AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
619235|NCT01038635|P7|Participant Flow|5-AZA + LEN 75 mg for 10 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
619660|NCT01038869|O1|Outcome|Azelaic Acid 15%|lesion counts
619237|NCT01038635|P5|Participant Flow|5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
619238|NCT01038635|P4|Participant Flow|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
619239|NCT01038635|P3|Participant Flow|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
619240|NCT01038635|P2|Participant Flow|5-AZA + LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
619241|NCT01038635|P1|Participant Flow|5-AZA + LEN 10 mg|Phase I: 5-Azacytidine (5-AZA) + Lenalidomide (LEN): 5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
619242|NCT01038635|O1|Outcome|Overall Study: 5-AZA + LEN MTD|Combined reporting for all phases, Phase I (5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10) and Phase II All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
619243|NCT01038635|O2|Outcome|Phase II: 5-AZA + LEN|All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg was administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
619244|NCT01038635|O1|Outcome|Phase I: 5-AZA + LEN MTD|5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
619245|NCT01038635|O7|Outcome|5-AZA + 10 Days LEN 75 mg 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
619246|NCT01038635|O6|Outcome|5-AZA + 5 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
619247|NCT01038635|O5|Outcome|5-AZA + 5 Days LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
619248|NCT01038635|O4|Outcome|5-AZA + 5 Days LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
619620|NCT01031680|B1|Baseline|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
619251|NCT01038635|O1|Outcome|5-AZA + 5 Days LEN 10 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
619252|NCT01038635|E9|Reported Event|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
619253|NCT01038635|E8|Reported Event|Phase II: AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
619254|NCT01038635|E7|Reported Event|5-AZA + 10 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
619255|NCT01038635|E6|Reported Event|5-AZA + 5 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
619256|NCT01038635|E5|Reported Event|5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
619257|NCT01038635|E4|Reported Event|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
619258|NCT01038635|E3|Reported Event|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
619259|NCT01038635|E2|Reported Event|5-AZA + LEN 15 mg|Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
619260|NCT01038635|E1|Reported Event|5-AZA + LEN 10 mg|Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
619261|NCT01038713|B4|Baseline|Total|Total of all reporting groups
619262|NCT01038713|B3|Baseline|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619263|NCT01038713|B2|Baseline|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619264|NCT01038713|B1|Baseline|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619265|NCT01038713|P3|Participant Flow|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619266|NCT01038713|P2|Participant Flow|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619267|NCT01038713|P1|Participant Flow|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619268|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619269|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619450|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619517|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619270|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619271|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619272|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619273|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619274|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619275|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619276|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
627968|NCT01059760|O3|Outcome|Change When Fed|
619277|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619278|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619279|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619280|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619281|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619282|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619283|NCT01038713|E3|Reported Event|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619284|NCT01038713|E2|Reported Event|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619285|NCT01038713|E1|Reported Event|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.
Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
619286|NCT01038752|B3|Baseline|Total|Total of all reporting groups
619287|NCT01038752|B2|Baseline|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.
Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619288|NCT01038752|B1|Baseline|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619451|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d.) with the first bite of a meal
619452|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d.) 10 minutes immediately before 3 meals
619289|NCT01038752|P2|Participant Flow|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.
Placebo, Docetaxel, Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619290|NCT01038752|P1|Participant Flow|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Suramin, Docetaxel, Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619291|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.
Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619292|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619293|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.
Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619294|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619295|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.
Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619623|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
619296|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619297|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.
Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619298|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619299|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.
Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619300|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619301|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.
Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619302|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619303|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.
Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619304|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619305|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.
Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619453|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d.) with the first bite of a meal
619306|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619307|NCT01038752|E2|Reported Event|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.
Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619308|NCT01038752|E1|Reported Event|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
619309|NCT01030718|B4|Baseline|Total|Total of all reporting groups
619310|NCT01030718|B3|Baseline|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619311|NCT01030718|B2|Baseline|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619312|NCT01030718|B1|Baseline|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619389|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619313|NCT01030718|P3|Participant Flow|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Philadelphia chromosome positive (Ph+) ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619314|NCT01030718|P2|Participant Flow|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619315|NCT01030718|P1|Participant Flow|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619316|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619317|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619318|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619319|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619320|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619454|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d.) 10 minutes immediately before 3 meals
619661|NCT01038869|O1|Outcome|Azelaic Acid 15%|
619321|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619322|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619323|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619324|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619325|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619326|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619342|NCT01030718|O3|Outcome|CML-AP/BP - Imatinib Intolerant|Imatinib intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619327|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619328|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619329|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619330|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619331|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619332|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619333|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619334|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619335|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619336|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619337|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619338|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619339|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Intolerant|Ph+ ALL subjects with intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619340|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Resistant|Ph+ ALL subjects with resistance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619341|NCT01030718|O1|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Total Cohort|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619477|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
619343|NCT01030718|O2|Outcome|CML-AP/BP - Imatinib Resistant|Imatinib resistant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619344|NCT01030718|O1|Outcome|CML-AP/BP - Total Cohort|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619345|NCT01030718|O3|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Intolerant|Imatinib intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619346|NCT01030718|O2|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Resistant|Imatinib resistant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619347|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP) Total|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619348|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619349|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619350|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619366|NCT01030718|O3|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Intolerant|Imatinib intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619351|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619352|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619353|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619354|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619355|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619356|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619357|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619390|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619621|NCT01031680|P2|Participant Flow|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
619358|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619359|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619360|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Intolerant|Ph+ ALL subjects with intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619361|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Resistant|Ph+ ALL subjects with resistance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619362|NCT01030718|O1|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Total Cohort|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619363|NCT01030718|O3|Outcome|CML-AP/BP - Imatinib Intolerant|Imatinib intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619364|NCT01030718|O2|Outcome|CML-AP/BP - Imatinib Resistant|Imatinib resistant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619365|NCT01030718|O1|Outcome|CML-AP/BP - Total Cohort|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619367|NCT01030718|O2|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Resistant|Imatinib resistant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619368|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP) Total|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619369|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619370|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619371|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619372|NCT01030718|E1|Reported Event|All Treated Participants|Imatinib resistant or intolerant CML-CP disease cohort, Imatinib resistant or intolerant CML-AP/BP disease cohort, and Ph+ ALL subjects with resistance or intolerance to past therapy. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
619388|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619373|NCT01030757|B1|Baseline|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.
Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours
Dose will be prescribed to the isodose line which covers at least 90% of the PTV
Dose homogeneity +/- 5%"
619374|NCT01030757|P1|Participant Flow|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.
Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours
Dose will be prescribed to the isodose line which covers at least 90% of the PTV
Dose homogeneity +/- 5%"
619375|NCT01030757|O1|Outcome|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.
Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours
Dose will be prescribed to the isodose line which covers at least 90% of the PTV
Dose homogeneity +/- 5%"
619376|NCT01030757|O1|Outcome|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.
Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours
Dose will be prescribed to the isodose line which covers at least 90% of the PTV
Dose homogeneity +/- 5%"
619377|NCT01030757|E1|Reported Event|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.
Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours
Dose will be prescribed to the isodose line which covers at least 90% of the PTV
Dose homogeneity +/- 5%"
619378|NCT01030822|B4|Baseline|Total|Total of all reporting groups
619447|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619448|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619449|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619379|NCT01030822|B3|Baseline|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619380|NCT01030822|B2|Baseline|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619381|NCT01030822|B1|Baseline|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619382|NCT01030822|P3|Participant Flow|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619383|NCT01030822|P2|Participant Flow|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619384|NCT01030822|P1|Participant Flow|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619385|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619386|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619387|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619474|NCT01030965|P2|Participant Flow|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
619391|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619392|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619393|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619394|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619395|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619396|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619397|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619398|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619399|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619400|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619401|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619402|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619403|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619404|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619405|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619406|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619407|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619408|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619475|NCT01030965|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
619409|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619410|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619411|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619412|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619413|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619414|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619415|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619416|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619417|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619418|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619419|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619420|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619421|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619422|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619423|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619424|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619425|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619426|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619476|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
627969|NCT01059760|O2|Outcome|Change While Fasting|
619427|NCT01030822|E3|Reported Event|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
619428|NCT01030822|E2|Reported Event|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
619429|NCT01030822|E1|Reported Event|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
619430|NCT01030952|B3|Baseline|Total|Total of all reporting groups
619431|NCT01030952|B2|Baseline|Acarbose|patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal
619432|NCT01030952|B1|Baseline|Nateglinide|120 mg by mouth, three times daily 10 minutes immediately before 3 meals
619433|NCT01030952|P2|Participant Flow|Acarbose|patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal
619434|NCT01030952|P1|Participant Flow|Nateglinide|120 mg by mouth, three times daily 10 minutes immediately before 3 meals
619435|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619436|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619437|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619438|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619439|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619440|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619441|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619442|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619443|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619444|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619445|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619446|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619455|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619456|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619457|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619458|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619459|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619460|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619461|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619462|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619463|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619464|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619465|NCT01030952|E2|Reported Event|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
619466|NCT01030952|E1|Reported Event|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
619467|NCT01030965|B5|Baseline|Total|Total of all reporting groups
619468|NCT01030965|B4|Baseline|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
619469|NCT01030965|B3|Baseline|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
619470|NCT01030965|B2|Baseline|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
619471|NCT01030965|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
619472|NCT01030965|P4|Participant Flow|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
619473|NCT01030965|P3|Participant Flow|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
619622|NCT01031680|P1|Participant Flow|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
619478|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
619479|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
619480|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
619481|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
619482|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
619483|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
619484|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
619485|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
619486|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
619487|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
619488|NCT01030965|E4|Reported Event|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
619489|NCT01030965|E3|Reported Event|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
619490|NCT01030965|E2|Reported Event|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
619491|NCT01030965|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
619492|NCT01031004|B3|Baseline|Total|Total of all reporting groups
619493|NCT01031004|B2|Baseline|Etafilcon A|contact lens worn as single use, daily wear
619494|NCT01031004|B1|Baseline|Narafilcon B|single use, daily wear contact lens
619495|NCT01031004|P2|Participant Flow|Etafilcon A|contact lens worn as single use, daily wear
619496|NCT01031004|P1|Participant Flow|Narafilcon B|single use, daily wear contact lens
619497|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619498|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619499|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619500|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619501|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619502|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619503|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619504|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619505|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619506|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619507|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619508|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619509|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619510|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619511|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619512|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619513|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619514|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619515|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619518|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619519|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619520|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619521|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619522|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619523|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619524|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619525|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619526|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619527|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619528|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619529|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619530|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619531|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
619532|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
619533|NCT01031004|E2|Reported Event|Etafilcon A|contact lens worn as single use, daily wear
619534|NCT01031004|E1|Reported Event|Narafilcon B|single use, daily wear contact lens
619535|NCT01031043|B1|Baseline|Topical Bethanechol|patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device
619557|NCT01031134|E2|Reported Event|Usual Care|"Physician Usual Care of depressed patients.
Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
627970|NCT01059760|O1|Outcome|Baseline Value|
619536|NCT01031043|P1|Participant Flow|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device
Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
619537|NCT01031043|O1|Outcome|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device
Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
619538|NCT01031043|E1|Reported Event|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device
Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
619539|NCT01031095|B3|Baseline|Total|Total of all reporting groups
619540|NCT01031095|B2|Baseline|Standard Therapy|standard UFH treatment
619541|NCT01031095|B1|Baseline|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
619542|NCT01031095|P2|Participant Flow|Standard Therapy|standard unfractionated heparin (UFH) treatment
619543|NCT01031095|P1|Participant Flow|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
619544|NCT01031095|O1|Outcome|Low Dose Intracoronary Heparin Treatment Arm|low dose intracoronary heparin treatment arm (intracoronary 1000 IU unfractioned heparin arm)
619545|NCT01031095|O1|Outcome|Standard Therapy|standard UFH treatment (intravenous standard dose unfractioned heparin group)
619546|NCT01031095|E2|Reported Event|Standard Therapy|standard UFH treatment
619547|NCT01031095|E1|Reported Event|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
619548|NCT01031134|B3|Baseline|Total|Total of all reporting groups
619549|NCT01031134|B2|Baseline|Usual Care|"Physician Usual Care of depressed patients.
Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
619550|NCT01031134|B1|Baseline|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
619551|NCT01031134|P2|Participant Flow|Usual Care|"Physician Usual Care of depressed patients.
Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
619662|NCT01038869|O1|Outcome|Azelaic Acis 15% Open Label|Assessments of PIH IGA
619552|NCT01031134|P1|Participant Flow|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
619553|NCT01031134|O2|Outcome|Usual Care|"Physician Usual Care of depressed patients.
Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
619554|NCT01031134|O1|Outcome|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
619555|NCT01031134|O2|Outcome|Usual Care|"Physician Usual Care of depressed patients.
Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
619556|NCT01031134|O1|Outcome|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
619558|NCT01031134|E1|Reported Event|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
619559|NCT01031381|B1|Baseline|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
619560|NCT01031381|P1|Participant Flow|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
619561|NCT01031381|O1|Outcome|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
619562|NCT01031381|O1|Outcome|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously.
619563|NCT01031381|E1|Reported Event|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
619564|NCT01031446|B1|Baseline|RAD001 Cisplatin Paclitaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks.
619565|NCT01031446|P1|Participant Flow|RAD001 and Cisplatin and Pacletaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks. All patients began at the same dose level of the study drugs with no de-escalation of dose, thus results for Phase I and II were combined
619566|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
619567|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
619568|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
619569|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
619570|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks
619571|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitazel|Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks
619572|NCT01031446|E1|Reported Event|RAD001 and Cisplatin and Paclitaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks.
619573|NCT01031498|B4|Baseline|Total|Total of all reporting groups
619574|NCT01031498|B3|Baseline|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
619575|NCT01031498|B2|Baseline|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
619658|NCT01038869|P1|Participant Flow|Finacea|Open label pilot study. All subjects were given Azelaic acid 15% to be used topically, twice daily.
619576|NCT01031498|B1|Baseline|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
619577|NCT01031498|P3|Participant Flow|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
619578|NCT01031498|P2|Participant Flow|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
619579|NCT01031498|P1|Participant Flow|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
619580|NCT01031498|O3|Outcome|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
619581|NCT01031498|O2|Outcome|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
619582|NCT01031498|O1|Outcome|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
619583|NCT01031498|E3|Reported Event|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
619584|NCT01031498|E2|Reported Event|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
619585|NCT01031498|E1|Reported Event|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
619586|NCT01031550|B3|Baseline|Total|Total of all reporting groups
619587|NCT01031550|B2|Baseline|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
619588|NCT01031550|B1|Baseline|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
619589|NCT01031550|P2|Participant Flow|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane, anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
619590|NCT01031550|P1|Participant Flow|Standard Anesthetic Management|standard anesthetic management propofol 100-150mcg/kg/min
619591|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
619592|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
619593|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
619594|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
619595|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
619596|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
619597|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane , anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
619598|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
619599|NCT01031550|E2|Reported Event|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane , anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
619600|NCT01031550|E1|Reported Event|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
619601|NCT01031628|B5|Baseline|Total|Total of all reporting groups
619602|NCT01031628|B4|Baseline|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619603|NCT01031628|B3|Baseline|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619604|NCT01031628|B2|Baseline|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619605|NCT01031628|B1|Baseline|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619606|NCT01031628|P4|Participant Flow|400, 600 or 800 mg for Patients With Exon 9 Mutation Tumors|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619607|NCT01031628|P3|Participant Flow|400 mg for Patients With Imatinib Blood Levels ≥ 1100|"Patients with imatinib trough blood levels ≥1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619608|NCT01031628|P2|Participant Flow|600 or 800 mg for Patients With Imatinib Blood Levels < 1100|"Patients with imatinib trough blood levels less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619609|NCT01031628|P1|Participant Flow|400 mg for Patients With Imatinib Blood Levels < 1100|"Patients with imatinib trough blood levels less than 1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619610|NCT01031628|O4|Outcome|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619611|NCT01031628|O3|Outcome|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619612|NCT01031628|O2|Outcome|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619613|NCT01031628|O1|Outcome|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619614|NCT01031628|E4|Reported Event|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619615|NCT01031628|E3|Reported Event|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619616|NCT01031628|E2|Reported Event|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619617|NCT01031628|E1|Reported Event|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
619618|NCT01031680|B3|Baseline|Total|Total of all reporting groups
619619|NCT01031680|B2|Baseline|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
619624|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
619625|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
619626|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
619627|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
619628|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
619629|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
619630|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
619631|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
619632|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
619633|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
619634|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
619635|NCT01031680|E2|Reported Event|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
619636|NCT01031680|E1|Reported Event|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
619637|NCT01031706|B3|Baseline|Total|Total of all reporting groups
619638|NCT01031706|B2|Baseline|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
619639|NCT01031706|B1|Baseline|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow
Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
619640|NCT01031706|P2|Participant Flow|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
619641|NCT01031706|P1|Participant Flow|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow
Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
619642|NCT01031706|O2|Outcome|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
619643|NCT01031706|O1|Outcome|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow
Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
619644|NCT01031706|O2|Outcome|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
619645|NCT01031706|O1|Outcome|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow
Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
619646|NCT01031706|E2|Reported Event|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
619647|NCT01031706|E1|Reported Event|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow
Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
619648|NCT01031810|B1|Baseline|Tranylcypromine|patients will receive treatment with tranylcypromine
619649|NCT01031810|P1|Participant Flow|Tranylcypromine|Patients will receive treatment with tranylcypromine tablets taken orally on a twice daily schedule. Dosage was initially 10 mg daily and was increased weekly up to 120 mg daily.
619650|NCT01031810|O1|Outcome|Tranylcypromine|patients will receive treatment with tranylcypromine Baseline Hamd17
619651|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine
tranylcypromine: MAO-Inhibitor 60mg-120mg"
619652|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine
tranylcypromine: MAO-Inhibitor 60mg-120mg"
619653|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine
tranylcypromine: MAO-Inhibitor 60mg-120mg"
619654|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine
tranylcypromine: monoamine oxidase inhibitor (MAOI) 60mg-120mg"
619655|NCT01031810|O1|Outcome|Tranylcypromine|patients will receive treatment with tranylcypromine Baseline Hamd17
619656|NCT01031810|E1|Reported Event|Tranylcypromine|patients will receive treatment with tranylcypromine
619657|NCT01038869|B1|Baseline|Finacea|Open label pilot study
619663|NCT01038869|O1|Outcome|Azelaic Acid 15% Open Label|Assessments of IGA
619664|NCT01038869|E1|Reported Event|Finacea|Open label pilot study
619665|NCT01038921|B3|Baseline|Total|Total of all reporting groups
619666|NCT01038921|B2|Baseline|Placebo First|Cross-over design with subjects receiving Placebo First
619667|NCT01038921|B1|Baseline|Melatonin First|Cross-over design with subjects receiving Melatonin First
619668|NCT01038921|P2|Participant Flow|Placebo|Cross-over design with subjects receiving either Placebo First and Melatonin Second or Melatonin First and Placebo Second
619669|NCT01038921|P1|Participant Flow|Melatonin|Cross-over design with subject receiving either Melatonin First and Placebo Second or Placebo First and Melatonin Second
619670|NCT01038921|O2|Outcome|Placebo|Cross-over design for all subjects on Placebo for 10 weeks measured at baseline and at 10 weeks.
619671|NCT01038921|O1|Outcome|Melatonin|Cross-over design for subjects on Melatonin for 10 weeks measured at baseline and 10 weeks
619672|NCT01038921|E2|Reported Event|Placebo First|Cross-over design for subjects randomized to Placebo First, Melatonin Second
619673|NCT01038921|E1|Reported Event|Melatonin First|Cross-over design for subjects randomized to Melatonin First, Placebo Second
619674|NCT01039376|B3|Baseline|Total|Total of all reporting groups
619675|NCT01039376|B2|Baseline|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619676|NCT01039376|B1|Baseline|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619677|NCT01039376|P2|Participant Flow|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619678|NCT01039376|P1|Participant Flow|Ofatumumab|Participants with relapsed chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619679|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619680|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619681|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619682|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619683|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619684|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619685|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619686|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619687|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619688|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619689|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619690|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619691|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619692|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619693|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619694|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619695|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619696|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619697|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619698|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619699|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619700|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619701|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
621975|NCT01050543|O2|Outcome|Neostigmine|neostigmine 50 mcg/kg
619702|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619703|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619704|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619705|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619706|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619707|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619708|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619709|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619710|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619711|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619712|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619842|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619713|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619714|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619715|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619716|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619717|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619718|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619719|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619720|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619721|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619722|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619723|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619724|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619725|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619726|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619727|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619728|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619729|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619730|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619731|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619732|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619733|NCT01039376|E2|Reported Event|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
619734|NCT01039376|E1|Reported Event|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
619735|NCT01039428|B3|Baseline|Total|Total of all reporting groups
619736|NCT01039428|B2|Baseline|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
619737|NCT01039428|B1|Baseline|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
619738|NCT01039428|P2|Participant Flow|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
619739|NCT01039428|P1|Participant Flow|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
619740|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619741|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619742|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619743|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619744|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619745|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619746|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619747|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619748|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619749|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619750|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619751|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619752|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619753|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619754|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619755|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619756|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619757|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
619758|NCT01039428|E2|Reported Event|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
619759|NCT01039428|E1|Reported Event|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
619760|NCT01039519|B1|Baseline|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
619761|NCT01039519|P1|Participant Flow|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
619762|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
619763|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
619764|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
619765|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
619766|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
619767|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
619768|NCT01039519|E1|Reported Event|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
619769|NCT01039584|B4|Baseline|Total|Total of all reporting groups
619770|NCT01039584|B3|Baseline|Placebo|"vehicle of the test product
Placebo : vaginal cream"
619771|NCT01039584|B2|Baseline|Reference Product|"Gynazole 1 Vaginal Cream
Gynazole 1 vaginal cream : vaginal cream"
619772|NCT01039584|B1|Baseline|Test Product|"Butoconazole Nitrate Vaginal Cream
Butoconazole Nitrate Vaginal Cream : vaginal cream"
619773|NCT01039584|P3|Participant Flow|Placebo|"vehicle of the test product
Placebo : vaginal cream"
619774|NCT01039584|P2|Participant Flow|Reference Product|"Gynazole 1 Vaginal Cream
Gynazole 1 vaginal cream : vaginal cream"
619775|NCT01039584|P1|Participant Flow|Test Product|"Butoconazole Nitrate Vaginal Cream
Butoconazole Nitrate Vaginal Cream : vaginal cream"
619776|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product
Placebo : vaginal cream"
619777|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream
Gynazole 1 vaginal cream : vaginal cream"
619778|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream
Butoconazole Nitrate Vaginal Cream : vaginal cream"
619779|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product
Placebo : vaginal cream"
619780|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream
Gynazole 1 vaginal cream : vaginal cream"
619781|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream
Butoconazole Nitrate Vaginal Cream : vaginal cream"
619782|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product
Placebo : vaginal cream"
619783|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream
Gynazole 1 vaginal cream : vaginal cream"
619784|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream
Butoconazole Nitrate Vaginal Cream : vaginal cream"
619785|NCT01039584|E3|Reported Event|Placebo|"vehicle of the test product
Placebo : vaginal cream"
619786|NCT01039584|E2|Reported Event|Reference Product|"Gynazole 1 Vaginal Cream
Gynazole 1 vaginal cream : vaginal cream"
619787|NCT01039584|E1|Reported Event|Test Product|"Butoconazole Nitrate Vaginal Cream
Butoconazole Nitrate Vaginal Cream : vaginal cream"
619788|NCT01039675|B3|Baseline|Total|Total of all reporting groups
619789|NCT01039675|B2|Baseline|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
619790|NCT01039675|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
619791|NCT01039675|P2|Participant Flow|UMEC/VI 500/25 µg QD|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 500/25 micrograms (µg) QD via a DPI in the morning for 4 weeks.
619843|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619792|NCT01039675|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 4 weeks.
619793|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
619794|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
619795|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
619796|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
619797|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
619798|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
619799|NCT01039675|E2|Reported Event|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
619800|NCT01039675|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
619801|NCT01039792|B3|Baseline|Total|Total of all reporting groups
619802|NCT01039792|B2|Baseline|Active|"Active Methyl B12
Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
619803|NCT01039792|B1|Baseline|Placebo|"Placebo
Placebo: Syringes were tightly taped with opaque material to hide the color of the liquid"
619804|NCT01039792|P2|Participant Flow|Active|"Active Methyl B12
Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
619805|NCT01039792|P1|Participant Flow|Placebo|"Placebo
Placebo: placebo"
619806|NCT01039792|O2|Outcome|Active|"Active Methyl B12
Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
619807|NCT01039792|O1|Outcome|Placebo|"Placebo
Placebo: Syringes were tightly taped with opaque material to hide the color of the liquid"
619808|NCT01039792|E2|Reported Event|Active|"Active Methyl B12
Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
619809|NCT01039792|E1|Reported Event|Placebo|"Placebo
Placebo: placebo"
619810|NCT01040052|B1|Baseline|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
619811|NCT01040052|P1|Participant Flow|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
619812|NCT01040052|O1|Outcome|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
619813|NCT01040052|E1|Reported Event|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
619814|NCT01040130|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. 151 patients were assigned randomly to one of 3 treatment sequences in which they received each of 3 treatments. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
619815|NCT01040130|P6|Participant Flow|Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
619816|NCT01040130|P5|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
619817|NCT01040130|P4|Participant Flow|Olo 5mcg / Olo 10mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
619818|NCT01040130|P3|Participant Flow|Olo 5mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, placebo in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
619819|NCT01040130|P2|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Olodaterol 10 mcg qd in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
619820|NCT01040130|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
619821|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
619822|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
619823|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619824|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
619825|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
619826|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619827|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
619828|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
619829|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619830|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
619831|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
619832|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619833|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
619834|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
619835|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619836|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619837|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619838|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619839|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619840|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619841|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619844|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619845|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619846|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619847|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619848|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619849|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619850|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619851|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619852|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619853|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619854|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619855|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619856|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619857|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619858|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619859|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619860|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619861|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619862|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619863|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619864|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619865|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619866|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619867|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619868|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619869|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619870|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619871|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619872|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619873|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619874|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619875|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619876|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619877|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619878|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619879|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619880|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619881|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619882|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619883|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619884|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619885|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619886|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619887|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619888|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619889|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619890|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
619891|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
619892|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619893|NCT01040130|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
619894|NCT01040130|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
619895|NCT01040130|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
619896|NCT01040169|B3|Baseline|Total|Total of all reporting groups
619897|NCT01040169|B2|Baseline|ProClude Prophylaxis Paste|
619898|NCT01040169|B1|Baseline|Nupro C Prophylaxis Paste|
619899|NCT01040169|P2|Participant Flow|ProClude Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
619900|NCT01040169|P1|Participant Flow|Nupro C Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
619901|NCT01040169|O2|Outcome|ProClude Prophylaxis Paste|
619902|NCT01040169|O1|Outcome|Nupro C Prophylaxis Paste|
619903|NCT01040169|O2|Outcome|ProClude Prophylaxis Paste|
619904|NCT01040169|O1|Outcome|Nupro C Prophylaxis Paste|
619905|NCT01040169|E2|Reported Event|ProClude Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
619906|NCT01040169|E1|Reported Event|Nupro C Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
619907|NCT01040208|B4|Baseline|Total|Total of all reporting groups
619908|NCT01040208|B3|Baseline|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
619909|NCT01040208|B2|Baseline|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
619910|NCT01040208|B1|Baseline|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
619911|NCT01040208|P3|Participant Flow|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
619912|NCT01040208|P2|Participant Flow|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
619913|NCT01040208|P1|Participant Flow|Flibanserin 50 mg to 100 mg Qhs (Take Daily, at Bedtime)|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
619914|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|
619915|NCT01040208|O2|Outcome|Flibanserin 100mg Qhs|
619916|NCT01040208|O1|Outcome|Flibanserin 50mg to 100mg Qhs|Group includes the 45 patients who took flibanserin 50 mg q.h.s. for the first 2 weeks followed by flibanserin 100 mg q.h.s.
619917|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|
619918|NCT01040208|O2|Outcome|Flibanserin 100 mg Qhs|
619919|NCT01040208|O1|Outcome|Flibanserin 50 mg to 100 mg Qhs|
619920|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
619921|NCT01040208|O2|Outcome|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
619922|NCT01040208|O1|Outcome|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
619923|NCT01040208|E3|Reported Event|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
619924|NCT01040208|E2|Reported Event|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
619925|NCT01040208|E1|Reported Event|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
619926|NCT01040260|B3|Baseline|Total|Total of all reporting groups
619927|NCT01040260|B2|Baseline|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
619928|NCT01040260|B1|Baseline|Contingency Management|Use of tangible rewards for verified abstinence
619929|NCT01040260|P2|Participant Flow|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
619930|NCT01040260|P1|Participant Flow|Contingency Management|Use of tangible rewards for verified abstinence
619931|NCT01040260|O2|Outcome|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
619932|NCT01040260|O1|Outcome|Contingency Management|Use of tangible rewards for verified abstinence
619933|NCT01040260|E2|Reported Event|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
619934|NCT01040260|E1|Reported Event|Contingency Management|Use of tangible rewards for verified abstinence
619935|NCT01040351|B3|Baseline|Total|Total of all reporting groups
619936|NCT01040351|B2|Baseline|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
619937|NCT01040351|B1|Baseline|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
619938|NCT01040351|P2|Participant Flow|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
619939|NCT01040351|P1|Participant Flow|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
619940|NCT01040351|O2|Outcome|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
620170|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
619941|NCT01040351|O1|Outcome|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
619942|NCT01040351|O2|Outcome|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
619943|NCT01040351|O1|Outcome|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
619944|NCT01040351|E2|Reported Event|2. no Aspiration|IVF-ET without any prior intervention
619945|NCT01040351|E1|Reported Event|1: Hydrosalpinx Needle Aspiration|Aspiration of hydrosalpingeal fluid prior to IVF-ET
619946|NCT01040403|B1|Baseline|Overall Study|"A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:
Olodaterol 5 µg and placebo
Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution
Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution
Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution
Olodaterol 10 µg and placebo
Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution
Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution
Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution"
619947|NCT01040403|P1|Participant Flow|Overall Study|"A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:
Olodaterol 5 µg and placebo
Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution
Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution
Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution
Olodaterol 10 µg and placebo
Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution
Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution
Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution"
619976|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619948|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619949|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619950|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619951|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619952|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619953|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619954|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619955|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619956|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619957|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619958|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619959|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619960|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619961|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619962|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619963|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619964|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620171|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
619965|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619966|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619967|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619968|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619969|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619970|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619971|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619972|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619973|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619974|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619975|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619977|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619978|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619979|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619980|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619981|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619982|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619983|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619984|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619985|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619986|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619987|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619988|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619989|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619990|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619991|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619992|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619993|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619994|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619995|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
619996|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619997|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619998|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
619999|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620000|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620001|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620002|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620003|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620004|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620005|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620006|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620007|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620008|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620009|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620010|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620011|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620012|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620013|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620014|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620015|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620016|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620017|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620018|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620019|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620020|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620021|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620022|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620023|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620024|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620025|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620026|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620027|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620028|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620029|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620030|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620031|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620032|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620033|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620034|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620035|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620036|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620037|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620038|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620039|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620040|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620041|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620042|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620043|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620044|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620045|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620046|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620047|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620048|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620049|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620050|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620051|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620052|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620053|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620054|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620055|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620056|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620057|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620058|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620059|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620060|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620061|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620062|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620063|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620064|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620065|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620066|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620067|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620068|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620069|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620070|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620071|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620072|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620073|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620074|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620075|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620076|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620077|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620078|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620079|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620080|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620081|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620082|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620083|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620084|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620085|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620086|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620087|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620088|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620089|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620090|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620091|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620092|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620093|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620094|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620095|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620096|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620097|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620098|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620099|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620100|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620101|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620102|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620103|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620104|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620105|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620106|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620107|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620108|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620109|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620110|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620111|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620112|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620113|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620114|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620115|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620116|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620117|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
620118|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620119|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620120|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620121|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620122|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620123|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620124|NCT01040403|E8|Reported Event|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620125|NCT01040403|E7|Reported Event|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620126|NCT01040403|E6|Reported Event|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620127|NCT01040403|E5|Reported Event|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620128|NCT01040403|E4|Reported Event|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620129|NCT01040403|E3|Reported Event|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620130|NCT01040403|E2|Reported Event|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
620131|NCT01040403|E1|Reported Event|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
620132|NCT01040624|B3|Baseline|Total|Total of all reporting groups
620133|NCT01040624|B2|Baseline|HR-B|"> 15% risk of + LN
> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
620172|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620134|NCT01040624|B1|Baseline|HR-A|"< 15% risk of + LN
< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
620135|NCT01040624|P2|Participant Flow|HR-B|"> 15% risk of + LN
> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
620136|NCT01040624|P1|Participant Flow|HR-A|"< 15% risk of + lymph nodes (LN)
< 15% risk of + LN: Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months."
620137|NCT01040624|O2|Outcome|HR-B|"> 15% risk of + LN
> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
620138|NCT01040624|O1|Outcome|HR-A|"< 15% risk of + LN
< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
620139|NCT01040624|E2|Reported Event|HR-B|"> 15% risk of + LN
> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
620140|NCT01040624|E1|Reported Event|HR-A|"< 15% risk of + LN
< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
620141|NCT01040689|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 108 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Tiotropium (Tio) 18 mcg once daily (qd) delivered via the HandiHaler or equivalent placebo. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
620194|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620142|NCT01040689|P4|Participant Flow|Tio 18mcg / Olo 5mcg / Placebo / Olo 10mcg|Patients were administered Tiotropium 18 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
620143|NCT01040689|P3|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg / Tio 18mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Olodaterol 5 mcg qd in the third period and Tiotropium 18 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
620144|NCT01040689|P2|Participant Flow|Olo 5mcg / Olo 10mcg / Tio 18mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Tiotropium 18 mcg qd in the third period and placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
620145|NCT01040689|P1|Participant Flow|Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Tiotropium 18 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
620146|NCT01040689|O4|Outcome|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
620147|NCT01040689|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620148|NCT01040689|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620149|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620150|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620151|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620152|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620153|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620154|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620155|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620156|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620157|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620158|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620159|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620160|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620161|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620162|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620163|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620164|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620165|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620166|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620167|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620168|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620169|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620173|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620174|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620175|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620176|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620177|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620178|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620179|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620180|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620181|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620182|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620183|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620184|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620185|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620186|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620187|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620188|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620189|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620190|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620191|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620192|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620193|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620195|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
620196|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620197|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620198|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620199|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620200|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620201|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620202|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620203|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620204|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620205|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620206|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
620207|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620208|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620209|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620210|NCT01040689|E4|Reported Event|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
620211|NCT01040689|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620212|NCT01040689|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620213|NCT01040689|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
620214|NCT01040728|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 122 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Tiotropium (Tio) 18 mcg once daily (qd) delivered via the HandiHaler or equivalent placebo. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
620215|NCT01040728|P4|Participant Flow|Tio 18mcg / Olo 5mcg / Placebo / Olo 10mcg|"Patients were administered Tiotropium 18 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period.
Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
620216|NCT01040728|P3|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg / Tio 18mcg|"Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Olodaterol 5 mcg qd in the third period and Tiotropium 18 mcg qd in the fourth period.
Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
620217|NCT01040728|P2|Participant Flow|Olo 5mcg / Olo 10mcg / Tio 18mcg / Placebo|"Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Tiotropium 18 mcg qd in the third period and placebo in the fourth period.
Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
620218|NCT01040728|P1|Participant Flow|Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg|"Patients were administered placebo in the first period, Tiotropium 18 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 5 mcg qd in the fourth period.
Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
620219|NCT01040728|O4|Outcome|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
620220|NCT01040728|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620221|NCT01040728|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620222|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620223|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620224|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620225|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620226|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620227|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620228|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620229|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620230|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620231|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620232|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620233|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620234|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620235|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620236|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620237|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620238|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620239|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620240|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620241|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620242|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620243|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620244|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620245|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620246|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620247|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620248|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620249|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620250|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620251|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620252|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620253|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620254|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620255|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620256|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620257|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620258|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620259|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620260|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620261|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620262|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620263|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620264|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620265|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620266|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620267|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620268|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
620269|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620270|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620271|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620272|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620273|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620274|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620275|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
620276|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620277|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620278|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620279|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
620280|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620281|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620282|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
620283|NCT01040728|E4|Reported Event|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
620284|NCT01040728|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620285|NCT01040728|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620286|NCT01040728|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620287|NCT01040780|B3|Baseline|Total|Total of all reporting groups
620288|NCT01040780|B2|Baseline|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
620289|NCT01040780|B1|Baseline|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
620290|NCT01040780|P2|Participant Flow|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
620291|NCT01040780|P1|Participant Flow|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
620292|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
620293|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
620294|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
620295|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
620296|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
620297|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
620298|NCT01040780|O2|Outcome|Gefitinib|250 mg daily by mouth
620299|NCT01040780|O1|Outcome|Icotinib|125 mg three times daily (375 mg per day) by mouth
620300|NCT01040780|O2|Outcome|Gefitinib|250 mg every 24 hours by mouth
620301|NCT01040780|O1|Outcome|Icotinib|125 mg three times daily (375 mg per day) by mouth
620302|NCT01040780|E2|Reported Event|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
620303|NCT01040780|E1|Reported Event|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
620358|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620304|NCT01040793|B1|Baseline|Overall Study|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. 151 patients were assigned randomly to one of 3 treatment sequences in which they received each of 3 treatments. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
620305|NCT01040793|P6|Participant Flow|Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
620306|NCT01040793|P5|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
620307|NCT01040793|P4|Participant Flow|Olo 5mcg / Olo 10mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
620308|NCT01040793|P3|Participant Flow|Olo 5mcg/ Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, placebo in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
620309|NCT01040793|P2|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Olodaterol 10 mcg qd in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
620310|NCT01040793|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
620311|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620312|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620313|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620314|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620315|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620316|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620317|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620318|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620319|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620320|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620321|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620322|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620323|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620324|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620325|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620326|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620327|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620328|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620329|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620330|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620331|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620332|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620333|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620334|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620335|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620336|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620337|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620338|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620339|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620340|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620341|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620342|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620343|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620344|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620345|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620346|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620347|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620348|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620349|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620350|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620351|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620352|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620353|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620354|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620355|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620356|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620357|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620359|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620360|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620361|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620362|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620363|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620364|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620365|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620366|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620367|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620368|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620369|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620370|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620371|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620372|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620373|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620374|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620375|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620376|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620377|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620378|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620379|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620380|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
620381|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
620382|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
620383|NCT01040793|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
620384|NCT01040793|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
620385|NCT01040793|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
620386|NCT01040819|B3|Baseline|Total|Total of all reporting groups
620387|NCT01040819|B2|Baseline|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
620388|NCT01040819|B1|Baseline|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
620389|NCT01040819|P2|Participant Flow|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
620557|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
621976|NCT01050543|O1|Outcome|Sugammadex|sugammadex 2 mg/kg
620390|NCT01040819|P1|Participant Flow|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
620391|NCT01040819|O2|Outcome|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
620392|NCT01040819|O1|Outcome|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
620393|NCT01040819|E2|Reported Event|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
620579|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
620394|NCT01040819|E1|Reported Event|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
620395|NCT01040832|B3|Baseline|Total|Total of all reporting groups
620396|NCT01040832|B2|Baseline|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620397|NCT01040832|B1|Baseline|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620398|NCT01040832|P2|Participant Flow|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620399|NCT01040832|P1|Participant Flow|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620400|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620401|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620450|NCT01040858|O1|Outcome|Arm 1|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620752|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
620402|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620403|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620404|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620405|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620406|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620435|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620407|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620408|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620409|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620410|NCT01040832|E2|Reported Event|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620411|NCT01040832|E1|Reported Event|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
620412|NCT01040845|B3|Baseline|Total|Total of all reporting groups
620413|NCT01040845|B2|Baseline|Oral Contraceptive With Colchicine Then Placebo|All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
620414|NCT01040845|B1|Baseline|Oral Contraceptive With Placebo Then Colchicine|All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
620415|NCT01040845|P2|Participant Flow|Oral Contraceptive With Colchicine Then Placebo|[All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (over-encapsulated colchicine tablets 0.6 mg during or matching placebo capsule during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.
620416|NCT01040845|P1|Participant Flow|Oral Contraceptive With Placebo Then Colchicine|[All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (matching placebo capsule during the first cycle or over-encapsulated colchicine tablets 0.6 mg during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.
620417|NCT01040845|O1|Outcome|Colchicine With Norethindrone/Ethinyl Estradiol|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
620418|NCT01040845|O1|Outcome|Ethinyl Estradiol With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
620574|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
620419|NCT01040845|O1|Outcome|Ethinyl Estradiol With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
620420|NCT01040845|O1|Outcome|Norethindrone With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
620421|NCT01040845|O1|Outcome|Norethindrone With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
620422|NCT01040845|O1|Outcome|Colchicine With Norethindrone/Ethinyl Estradiol|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
620423|NCT01040845|O1|Outcome|Ethinyl Estradiol With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
620424|NCT01040845|O1|Outcome|Ethinyl Estradiol With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
620425|NCT01040845|O1|Outcome|Norethindrone With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
620451|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620426|NCT01040845|O1|Outcome|Norethindrone With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
620427|NCT01040845|E1|Reported Event|Oral Contraceptive With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
620428|NCT01040858|B3|Baseline|Total|Total of all reporting groups
620429|NCT01040858|B2|Baseline|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620430|NCT01040858|B1|Baseline|Cognitive Strategies Group|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620431|NCT01040858|P2|Participant Flow|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620432|NCT01040858|P1|Participant Flow|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620433|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620434|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620575|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
620436|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620437|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620438|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620439|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620440|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620441|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620442|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620443|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620444|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620445|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620446|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620447|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620448|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620449|NCT01040858|O2|Outcome|Arm 2|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620551|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
620991|NCT01043432|O2|Outcome|Group 2|Moderate/Severe TBI and no history of suicidal behavior
620452|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620453|NCT01040858|O2|Outcome|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620454|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620455|NCT01040858|O2|Outcome|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620456|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620457|NCT01040858|E2|Reported Event|Arm 2|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
620458|NCT01040858|E1|Reported Event|Arm 1|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
620459|NCT01040871|B3|Baseline|Total|Total of all reporting groups
620460|NCT01040871|B2|Baseline|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
620461|NCT01040871|B1|Baseline|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
620462|NCT01040871|P2|Participant Flow|R-CHOP|R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone
620576|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620463|NCT01040871|P1|Participant Flow|VR-CAP|VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.
620464|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
620465|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
620466|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
620467|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
620468|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
620469|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
620470|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
620471|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
620472|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
620473|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
620474|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
620475|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
620476|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
620477|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
620478|NCT01040871|E2|Reported Event|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
620479|NCT01040871|E1|Reported Event|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
620480|NCT01041209|B3|Baseline|Total|Total of all reporting groups
620481|NCT01041209|B2|Baseline|Guideline|Enforced guidelines
620482|NCT01041209|B1|Baseline|Bacterial Pneumonia Score (BPS)|Bacterial Pneumonia Score (BPS) guidance
620483|NCT01041209|P2|Participant Flow|Guideline|Use of antibiotics according to local enforced guidelines
620484|NCT01041209|P1|Participant Flow|Bacterial Pneumonia Score (BPS)|Use of antibiotics according to Bacterial Pneumonia Score (BPS) guidance (antibiotic use when BPS > or = 4 points)
620485|NCT01041209|O2|Outcome|Guideline|Indication of antibiotics according to local (Hospital)guidelines.
620486|NCT01041209|O1|Outcome|Bacterial Pneumonia Score (BPS)|Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS >= 4 points
620487|NCT01041209|O2|Outcome|Guideline|Indication of antibiotics according to local (Hospital) guidelines
620488|NCT01041209|O1|Outcome|Bacterial Pneumonia Score (BPS)|Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS >= 4 points
620489|NCT01041209|E2|Reported Event|Guideline|Enforced guidelines
620490|NCT01041209|E1|Reported Event|Bacterial Pneumonia Score (BPS)|Bacterial Pneumonia Score (BPS) guidance
620491|NCT01041287|B3|Baseline|Total|Total of all reporting groups
620492|NCT01041287|B2|Baseline|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for 3 months. They crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620552|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
621977|NCT01050543|E2|Reported Event|Neostigmine|neostigmine 50 mcg/kg
620493|NCT01041287|B1|Baseline|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for 3 months. They crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620494|NCT01041287|P2|Participant Flow|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620495|NCT01041287|P1|Participant Flow|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620496|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620497|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620577|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
621094|NCT01044030|B2|Baseline|Placebo|Placebo: 7.5 mL by mouth three times daily
620498|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620499|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620500|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620501|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620502|NCT01041287|E2|Reported Event|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620503|NCT01041287|E1|Reported Event|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
620504|NCT01041404|B3|Baseline|Total|Total of all reporting groups
620505|NCT01041404|B2|Baseline|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620553|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
620554|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620506|NCT01041404|B1|Baseline|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620507|NCT01041404|P2|Participant Flow|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 milligrams per kilogram (mg/kg), IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620508|NCT01041404|P1|Participant Flow|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-fluorouracil [5-FU] or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, orally (PO), twice daily (BID) from the evening of Day 1 through the morning of Day 15.
620509|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620510|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620538|NCT01041404|O2|Outcome|Trastuzumab, Fluoropyrimidine, Cisplatin|Participants received an initial loading dose of trastuzumab 8 mg/kg, IV, on Day 1 of cycle, followed by 6 mg/kg, IV, every 3 weeks until disease progression. Participants also received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles; cisplatin 80 mg/m^2 IV on Day 1 of cycle every 3 weeks for 6 cycles; and capecitabine 1000 mg/m^2 PO twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
620511|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620512|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620513|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620514|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620515|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620516|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620517|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620555|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
620556|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620518|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620519|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620520|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620521|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620522|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620523|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620539|NCT01041404|O1|Outcome|Fluoropyrimidine, Cisplatin|Participants received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles. Participants also received cisplatin 80 mg/m^2, IV, on Day 1 of cycle every 3 weeks for 6 cycles; as well as, capecitabine 1000 mg/m^2, PO, twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
621095|NCT01044030|B1|Baseline|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
620524|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620525|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620526|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620527|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620528|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620529|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620530|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620531|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620532|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620533|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620534|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620535|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620536|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620537|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620540|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620541|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620542|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620543|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620544|NCT01041404|E2|Reported Event|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
620545|NCT01041404|E1|Reported Event|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
620546|NCT01041417|B3|Baseline|Total|Total of all reporting groups
620547|NCT01041417|B2|Baseline|Placebo|Saline injection - three times for four weeks
620548|NCT01041417|B1|Baseline|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620549|NCT01041417|P2|Participant Flow|Placebo|Saline injection - three times for four weeks
620550|NCT01041417|P1|Participant Flow|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620558|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620559|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
620560|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620561|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
620562|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620563|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
620564|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
620565|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
620566|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
620567|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
620568|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
620569|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
620570|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
620571|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
620572|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620573|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
620578|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620580|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620581|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
620582|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks
500 microgram dose of GM-CSF"
620583|NCT01041417|E2|Reported Event|Placebo|Saline injection - Monday, Wednesday and Friday for 4 weeks.
620584|NCT01041417|E1|Reported Event|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - Monday, Wednesday and Friday for 4 weeks of therapy.
500 microgram dose of GM-CSF"
620585|NCT01041573|B5|Baseline|Total|Total of all reporting groups
620586|NCT01041573|B4|Baseline|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day56 and month 7-13
620587|NCT01041573|B3|Baseline|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
620588|NCT01041573|B2|Baseline|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
620589|NCT01041573|B1|Baseline|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
620590|NCT01041573|P4|Participant Flow|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
620591|NCT01041573|P3|Participant Flow|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
620592|NCT01041573|P2|Participant Flow|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
620593|NCT01041573|P1|Participant Flow|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
620594|NCT01041573|O4|Outcome|Prevnar|"Subjects aged ≥ 2 to < 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7‐13 (subjects aged ≥ 2 to < 6 months were to receive the fourth Prevnar® vaccination when 12‐15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).
Subjects aged ≥ 6 months to < 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7."
620595|NCT01041573|O3|Outcome|Havrix 720|Havrix®720 0.5 ml im. at day 0 and month 7
620596|NCT01041573|O2|Outcome|IC51, Subjects Aged >= 2 Months to <1 Year|Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
620597|NCT01041573|O1|Outcome|IC51, Subjects Aged >= 1 Year|IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
620598|NCT01041573|E4|Reported Event|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
620599|NCT01041573|E3|Reported Event|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
620600|NCT01041573|E2|Reported Event|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
620601|NCT01041573|E1|Reported Event|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
620602|NCT01041638|B1|Baseline|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
620620|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
620603|NCT01041638|P1|Participant Flow|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
620604|NCT01041638|O1|Outcome|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
620605|NCT01041638|E1|Reported Event|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
620606|NCT01035047|B3|Baseline|Total|Total of all reporting groups
620607|NCT01035047|B2|Baseline|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
620825|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620608|NCT01035047|B1|Baseline|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
620609|NCT01035047|P2|Participant Flow|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
620610|NCT01035047|P1|Participant Flow|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
620611|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
620612|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
620613|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
620614|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
620615|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
620616|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
620617|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
620618|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
620619|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
620621|NCT01035047|E2|Reported Event|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
620753|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
620622|NCT01035047|E1|Reported Event|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
620623|NCT01035060|B3|Baseline|Total|Total of all reporting groups
620624|NCT01035060|B2|Baseline|Young Adults|
620625|NCT01035060|B1|Baseline|Older Adults|
620626|NCT01035060|P2|Participant Flow|Young Adults|Persons aged 18-30 years
620627|NCT01035060|P1|Participant Flow|Older Adults|Persons aged ≥ 70 years
620628|NCT01035060|O2|Outcome|Young Adults|Age 18-35 years
620629|NCT01035060|O1|Outcome|Older Adults|Age > 70 years
620630|NCT01035060|E2|Reported Event|Older Adults|
620631|NCT01035060|E1|Reported Event|Younger Adults|
620632|NCT01035138|B4|Baseline|Total|Total of all reporting groups
620633|NCT01035138|B3|Baseline|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620634|NCT01035138|B2|Baseline|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620635|NCT01035138|B1|Baseline|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620636|NCT01035138|P3|Participant Flow|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during this extension study (LFBF)
620637|NCT01035138|P2|Participant Flow|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 (LY 100 mg) orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during this extension study (LFBF)
620819|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620638|NCT01035138|P1|Participant Flow|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 milligram (mg) orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620639|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620640|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620641|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620642|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620643|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620644|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620645|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620646|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620647|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620648|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620649|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620650|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620651|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620652|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620653|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620654|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620992|NCT01043432|O1|Outcome|Group 1|Moderate/severe TBI and history of suicidal behavior
620655|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620656|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620657|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620658|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620659|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620660|NCT01035138|O1|Outcome|LY 140 mg|Participants received 140 mg LY450319 orally once daily up to 24 months during extension study (LFBF)
620661|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620662|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620663|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620664|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620665|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620861|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620666|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during Study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620667|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620668|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620669|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during Study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620670|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620671|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620672|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620673|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620674|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620675|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620676|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620677|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620678|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620679|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620680|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620681|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620682|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620683|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620684|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620685|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620686|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620687|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620688|NCT01035138|E3|Reported Event|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620689|NCT01035138|E2|Reported Event|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
620690|NCT01035138|E1|Reported Event|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
620691|NCT01035229|B3|Baseline|Total|Total of all reporting groups
620692|NCT01035229|B2|Baseline|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
620693|NCT01035229|B1|Baseline|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
620694|NCT01035229|P2|Participant Flow|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
620695|NCT01035229|P1|Participant Flow|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
620696|NCT01035229|O2|Outcome|Everolimus 5mg + Best Supportive Care (BSC)|Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed.
620697|NCT01035229|O1|Outcome|Everolimus 7.5mg + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
620698|NCT01035229|O2|Outcome|Everolimus 5mg + Best Supportive Care (BSC)|Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed.
620699|NCT01035229|O1|Outcome|Everolimus 7.5mg + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
620700|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
620701|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
620702|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
620703|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
620704|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
620705|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
620749|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
620706|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
620707|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
620708|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
620709|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
620710|NCT01035229|E2|Reported Event|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
620711|NCT01035229|E1|Reported Event|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
620712|NCT01035255|B3|Baseline|Total|Total of all reporting groups
620713|NCT01035255|B2|Baseline|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
620820|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
621096|NCT01044030|P2|Participant Flow|Placebo|Placebo: 7.5 mL by mouth three times daily
620714|NCT01035255|B1|Baseline|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
620715|NCT01035255|P2|Participant Flow|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
620716|NCT01035255|P1|Participant Flow|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
620717|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
620718|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
620719|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
620720|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
620721|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
620750|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
620751|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
620993|NCT01043432|E1|Reported Event|All Groups|
620722|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
620723|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
620724|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
620725|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
620726|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
620727|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
620821|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620822|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620728|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
620729|NCT01035255|E2|Reported Event|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
620730|NCT01035255|E1|Reported Event|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
620731|NCT01035333|B1|Baseline|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
620732|NCT01035333|P1|Participant Flow|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
620733|NCT01035333|O1|Outcome|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
620734|NCT01035333|O1|Outcome|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
620735|NCT01035333|E1|Reported Event|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
620736|NCT01035346|B3|Baseline|Total|Total of all reporting groups
620737|NCT01035346|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
620738|NCT01035346|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
620739|NCT01035346|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
620740|NCT01035346|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
620741|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
620742|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
620743|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
620744|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
620745|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
620746|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
620747|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
620748|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
621039|NCT01043705|B4|Baseline|Total|Total of all reporting groups
620754|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
620755|NCT01035346|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
620756|NCT01035346|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
620757|NCT01035658|B5|Baseline|Total|Total of all reporting groups
620758|NCT01035658|B4|Baseline|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620759|NCT01035658|B3|Baseline|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620760|NCT01035658|B2|Baseline|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620823|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620824|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620761|NCT01035658|B1|Baseline|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620762|NCT01035658|P4|Participant Flow|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620763|NCT01035658|P3|Participant Flow|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620764|NCT01035658|P2|Participant Flow|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620765|NCT01035658|P1|Participant Flow|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620766|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620767|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620804|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620805|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620768|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620769|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620770|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620771|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620772|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
621097|NCT01044030|P1|Participant Flow|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
620773|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620774|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620775|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620776|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620777|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620778|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620779|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620922|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
620780|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620781|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620782|NCT01035658|O1|Outcome|Phase 1|All patients in Phase I (this section contains the Maximum Tolerated Dose)
620783|NCT01035658|E4|Reported Event|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620784|NCT01035658|E3|Reported Event|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620785|NCT01035658|E2|Reported Event|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
627971|NCT01059760|O3|Outcome|Change When Fed|
620786|NCT01035658|E1|Reported Event|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
620787|NCT01035749|B5|Baseline|Total|Total of all reporting groups
620788|NCT01035749|B4|Baseline|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620789|NCT01035749|B3|Baseline|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620790|NCT01035749|B2|Baseline|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620791|NCT01035749|B1|Baseline|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620792|NCT01035749|P4|Participant Flow|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620793|NCT01035749|P3|Participant Flow|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620794|NCT01035749|P2|Participant Flow|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620795|NCT01035749|P1|Participant Flow|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620796|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620797|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620798|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620799|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620800|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620801|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620802|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620803|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620806|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620807|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620808|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620809|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620810|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620811|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620812|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620813|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620814|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620815|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620816|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620817|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620818|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
621098|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
620826|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620827|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620828|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620829|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620830|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620831|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620832|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620833|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620834|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620835|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620836|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620837|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620838|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620839|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620840|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620841|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620842|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620843|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620844|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620845|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620846|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620951|NCT01042093|O4|Outcome|REP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
620847|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620848|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620849|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620850|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620851|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620852|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620853|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620854|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620855|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620856|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620857|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620858|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620859|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620860|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620862|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620863|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620864|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620865|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620866|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620867|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620868|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620869|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620870|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620871|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620872|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620873|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620874|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620875|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620876|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620877|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620878|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620879|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620880|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620881|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620882|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620883|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620884|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620885|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620886|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620887|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620888|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620889|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620890|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620891|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620892|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620893|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620894|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620895|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620896|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620897|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620898|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620899|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620900|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620901|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620902|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620903|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620904|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620905|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620906|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620907|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620908|NCT01035749|E4|Reported Event|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620909|NCT01035749|E3|Reported Event|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
620910|NCT01035749|E2|Reported Event|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620911|NCT01035749|E1|Reported Event|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
620912|NCT01041859|B3|Baseline|Total|Total of all reporting groups
620913|NCT01041859|B2|Baseline|DB Placebo|Double-Blind Placebo Control Group
620914|NCT01041859|B1|Baseline|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
620915|NCT01041859|P3|Participant Flow|DB Placebo|Double-Blind Placebo Control Group
620916|NCT01041859|P2|Participant Flow|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
620917|NCT01041859|P1|Participant Flow|OL Tapentadol|Tapentadol extended release (ER) 50 100 150 200 250 mg twice daily for 3 weeks
620918|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
620919|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
620920|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
620921|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
620923|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
620924|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
620925|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
620926|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
620927|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
620928|NCT01041859|E3|Reported Event|DB Placebo|Double-Blind Placebo Control Group
620929|NCT01041859|E2|Reported Event|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
620930|NCT01041859|E1|Reported Event|OL Tapentadol|Tapentadol extended release (ER) 50 100 150 200 250 mg twice daily for 3 weeks
620931|NCT01041976|B3|Baseline|Total|Total of all reporting groups
620932|NCT01041976|B2|Baseline|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
620933|NCT01041976|B1|Baseline|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
620934|NCT01041976|P2|Participant Flow|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
620969|NCT01043393|B1|Baseline|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area.
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
627972|NCT01059760|O2|Outcome|Change While Fasting|
620935|NCT01041976|P1|Participant Flow|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
620936|NCT01041976|O2|Outcome|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
620937|NCT01041976|O1|Outcome|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
620938|NCT01041976|O2|Outcome|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
620939|NCT01041976|O1|Outcome|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
620940|NCT01041976|E2|Reported Event|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
620941|NCT01041976|E1|Reported Event|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
620942|NCT01042093|B5|Baseline|Total|Total of all reporting groups
620943|NCT01042093|B4|Baseline|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
620944|NCT01042093|B3|Baseline|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620945|NCT01042093|B2|Baseline|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
620946|NCT01042093|B1|Baseline|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620947|NCT01042093|P4|Participant Flow|REP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
620948|NCT01042093|P3|Participant Flow|REP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620949|NCT01042093|P2|Participant Flow|REP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
620950|NCT01042093|P1|Participant Flow|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620952|NCT01042093|O3|Outcome|REP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620953|NCT01042093|O2|Outcome|REP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
620954|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620955|NCT01042093|O4|Outcome|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
620956|NCT01042093|O3|Outcome|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620957|NCT01042093|O2|Outcome|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
620958|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620959|NCT01042093|O4|Outcome|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
620960|NCT01042093|O3|Outcome|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620961|NCT01042093|O2|Outcome|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
620962|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620963|NCT01042093|E4|Reported Event|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
620964|NCT01042093|E3|Reported Event|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620965|NCT01042093|E2|Reported Event|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
620966|NCT01042093|E1|Reported Event|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
620967|NCT01043393|B3|Baseline|Total|Total of all reporting groups
620968|NCT01043393|B2|Baseline|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area.
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
621002|NCT01043523|O1|Outcome|Precontrast|51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
620970|NCT01043393|P2|Participant Flow|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
620971|NCT01043393|P1|Participant Flow|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
620972|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
620973|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
620974|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
620975|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
620976|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
620977|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
620978|NCT01043393|E2|Reported Event|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
620979|NCT01043393|E1|Reported Event|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
620980|NCT01043432|B5|Baseline|Total|Total of all reporting groups
620981|NCT01043432|B4|Baseline|No TBI and no History of Suicidal Behavior Group 4|No TBI and no history of suicidal behavior
620982|NCT01043432|B3|Baseline|No TBI and a History of Suicidal Behavior Group 3|No TBI and a history of suicidal behavior
620983|NCT01043432|B2|Baseline|Moderate/Severe TBI and no History of Suicidal behaviorGroup 2|Moderate/Severe TBI and no history of suicidal behavior
620984|NCT01043432|B1|Baseline|Moderate/Severe TBI and History of Suicidal Behavior Group 1|Moderate/severe TBI and history of suicidal behavior
620985|NCT01043432|P4|Participant Flow|Group 4|No TBI and no history of suicidal behavior = 48
620986|NCT01043432|P3|Participant Flow|Group 3|No TBI and a history of suicidal behavior = 12
620987|NCT01043432|P2|Participant Flow|Group 2|Moderate/Severe TBI and no history of suicidal behavior = 51
620988|NCT01043432|P1|Participant Flow|Group 1|Moderate/severe TBI and history of suicidal behavior = 22
620989|NCT01043432|O4|Outcome|Group 4|No TBI and no history of suicidal behavior
620990|NCT01043432|O3|Outcome|Group 3|No TBI and a history of suicidal behavior
620994|NCT01043523|B1|Baseline|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
620995|NCT01043523|P1|Participant Flow|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
620996|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
620997|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
620998|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
620999|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621000|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621001|NCT01043523|O2|Outcome|Combined Precontrast / Postcontrast|51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
621099|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
621003|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621004|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621005|NCT01043523|O2|Outcome|Combined Precontrast / Postcontrast|Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
621006|NCT01043523|O1|Outcome|Precontrast|45 subjects had a change based on the Precontrast image read
621007|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621008|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621009|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621010|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621011|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621012|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621013|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621014|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621015|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621016|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621017|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
621018|NCT01043523|E1|Reported Event|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver MRI as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records.
621080|NCT01043939|B1|Baseline|Entire Study Population|Includes groups randomized to receive purple grape juice first and apple juice first
621019|NCT01043640|B1|Baseline|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621020|NCT01043640|P1|Participant Flow|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621021|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621022|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621023|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621024|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621025|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621026|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621040|NCT01043705|B3|Baseline|CIED Replacement With CRT and TYRX Vs. Case Match Arm|Prospective CRT patients who received a TYRX envelope and had a valid case match retrospective patient. This is a subset of all CRT/TYRX patients
621027|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621028|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621029|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621052|NCT01043705|E2|Reported Event|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
621030|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621031|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621032|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621033|NCT01043640|E1|Reported Event|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.
Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg
Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:
Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
621034|NCT01043653|B1|Baseline|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in VA mental health outpatient programs
621035|NCT01043653|P1|Participant Flow|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in mental health outpatient programs
621036|NCT01043653|O1|Outcome|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in VA mental health outpatient programs
621037|NCT01043653|O1|Outcome|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in VA mental health outpatient programs
621038|NCT01043653|E1|Reported Event|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in mental health outpatient programs
621041|NCT01043705|B2|Baseline|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
621042|NCT01043705|B1|Baseline|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
621043|NCT01043705|P3|Participant Flow|CRT With no TYRX Retrospective Case Control|Retrospective site matched and case-matched CRT replacement patients who did not receive a TYRX envelope selected in the era just prior to availability of TYRX Envelope
621044|NCT01043705|P2|Participant Flow|CRT and TYRX Cases, Matched to Retrospective Non-TYRX Implants|Patients receiving a TYRX envelope who were eligible to participate having a replacement CRT implant who have a valid non-TYRX implant case-match
621045|NCT01043705|P1|Participant Flow|ICD With TYRX Implant|All patients receiving a TYRX envelope who were eligible to participate having a replacement ICD implant
621046|NCT01043705|O3|Outcome|CIED Replacement With CRT and TYRX vs. Case Match Arm|CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
621047|NCT01043705|O2|Outcome|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
621048|NCT01043705|O1|Outcome|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
621049|NCT01043705|O3|Outcome|CIED Replacement With CRT and TYRX vs. Case Match Arm|CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
621050|NCT01043705|O2|Outcome|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
621051|NCT01043705|O1|Outcome|CIED Replacement With CRT and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
621053|NCT01043705|E1|Reported Event|CIED Replacement With CRT and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
621054|NCT01043874|B1|Baseline|Nilotinib|Nilotinib 400 mg BID
621055|NCT01043874|P1|Participant Flow|Nilotinib|Nilotinib 400 mg BID
621056|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
621057|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
621058|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
621059|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
621060|NCT01043874|E1|Reported Event|Nilotinib|Nilotinib 400 mg BID
621061|NCT01043926|B3|Baseline|Total|Total of all reporting groups
621062|NCT01043926|B2|Baseline|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621063|NCT01043926|B1|Baseline|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621064|NCT01043926|P4|Participant Flow|Healthy Participants (Part II)|Healthy participants matched to participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm.
621065|NCT01043926|P3|Participant Flow|Participants With Mild Hepatic Insufficiency (Part II)|Participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm.
621066|NCT01043926|P2|Participant Flow|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621067|NCT01043926|P1|Participant Flow|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621068|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621069|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621070|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621071|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621072|NCT01043926|O2|Outcome|Healthy Participants (Part II)|Healthy participants matched to participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
621073|NCT01043926|O1|Outcome|Participants With Mild Hepatic Insufficiency (Part II)|Participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
621074|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621075|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621076|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621077|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621078|NCT01043926|E2|Reported Event|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621079|NCT01043926|E1|Reported Event|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
621081|NCT01043939|P2|Participant Flow|Arm 2 Apple Juice Then Purple Grape Juice|Arm 2: 6 ounces of clear apple juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of purple grape juice twice daily during 4 weeks (intervention period 2).
621082|NCT01043939|P1|Participant Flow|Arm 1 Purple Grape Juice Then Apple Juice|Arm 1: 6 ounces of grape juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of clear apple juice twice daily during 4 weeks (intervention period 2).
621083|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
621084|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
621085|NCT01043939|O2|Outcome|Arm 2 Apple Juice Then Purple Grape Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
621086|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
621087|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
621088|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
621089|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
621090|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
621091|NCT01043939|E2|Reported Event|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
621092|NCT01043939|E1|Reported Event|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
621093|NCT01044030|B3|Baseline|Total|Total of all reporting groups
621100|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
621101|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
621102|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
621103|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
621104|NCT01044030|E2|Reported Event|Placebo|Placebo: 7.5 mL by mouth three times daily
621105|NCT01044030|E1|Reported Event|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
621106|NCT01044056|B4|Baseline|Total|Total of all reporting groups
621107|NCT01044056|B3|Baseline|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
621108|NCT01044056|B2|Baseline|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
621109|NCT01044056|B1|Baseline|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
621110|NCT01044056|P3|Participant Flow|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
621111|NCT01044056|P2|Participant Flow|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
621112|NCT01044056|P1|Participant Flow|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
621113|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
621114|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
621115|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
621116|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
621117|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
621118|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
621119|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
621194|NCT01044459|O2|Outcome|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
621452|NCT01044758|E1|Reported Event|aMCI_62.5|62.5 mg levetiracetam twice daily for two weeks
621120|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
621121|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
621122|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
621123|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
621124|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
621125|NCT01044056|E3|Reported Event|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|Nuvaring(R), one nring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonrgestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonorgestrel and 0.015 mg EE
621126|NCT01044056|E2|Reported Event|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgetromin and 0.750 mg EE releasing 0.150 mg norelegestromin and 0.020 mg EE per day.
621127|NCT01044056|E1|Reported Event|Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon(R) 30), 21 in total, containing 0.150 mg LNG and 0.030 EE per tablet administered once daily orally for 21 consecutive days.
621128|NCT01044212|B3|Baseline|Total|Total of all reporting groups
621129|NCT01044212|B2|Baseline|Docusate Controls|"Docusate is the standard of care regimen
Docusate sodium : Docusate 100mg BID"
621130|NCT01044212|B1|Baseline|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
621131|NCT01044212|P2|Participant Flow|Docusate Controls|"Docusate is the standard of care regimen
Docusate sodium : Docusate 100mg BID"
621132|NCT01044212|P1|Participant Flow|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
621133|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen
Docusate sodium : Docusate 100mg BID"
621134|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
621135|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen
Docusate sodium : Docusate 100mg BID"
621136|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
621137|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen
Docusate sodium : Docusate 100mg BID"
621138|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
621139|NCT01044212|E2|Reported Event|Docusate Controls|"Docusate is the standard of care regimen
Docusate sodium : Docusate 100mg BID"
621140|NCT01044212|E1|Reported Event|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
621141|NCT01044264|B4|Baseline|Total|Total of all reporting groups
621142|NCT01044264|B3|Baseline|Placebo|Placebo : Placebo
621143|NCT01044264|B2|Baseline|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
621144|NCT01044264|B1|Baseline|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
621145|NCT01044264|P3|Participant Flow|Placebo|Placebo : Placebo
621146|NCT01044264|P2|Participant Flow|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
621147|NCT01044264|P1|Participant Flow|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
621148|NCT01044264|O3|Outcome|Placebo|Placebo : Placebo
621149|NCT01044264|O2|Outcome|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
621150|NCT01044264|O1|Outcome|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
621151|NCT01044264|E3|Reported Event|Placebo|Placebo : Placebo
621152|NCT01044264|E2|Reported Event|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
621153|NCT01044264|E1|Reported Event|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
621154|NCT01044290|B4|Baseline|Total|Total of all reporting groups
621155|NCT01044290|B3|Baseline|Arm 3 Treatment as Usual|"Subjects in the third group (Treatment as Usual) were exposed to no intervention or attention control during the intervention window."
621156|NCT01044290|B2|Baseline|Arm 2 Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD"
621820|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
621157|NCT01044290|B1|Baseline|Arm 1 -Outlook Intervention|"Subjects in the first group (Outlook Intervention) completed a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on issues of heritage and legacy.
Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
621158|NCT01044290|P3|Participant Flow|Arm 3 Treatment as Usual|"Subjects in the third group (treatment as usual) were exposed to no intervention or attention control during the intervention window."
621159|NCT01044290|P2|Participant Flow|Attention Control|"Subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.
Attention Control: Subjects will listen to a non-guided relaxation CD"
621160|NCT01044290|P1|Participant Flow|Outlook Intervention|"Subjects in the first group (Outlook Intervention) completed a psychosocial intervention which consisted of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy."
621161|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention but rather care as usual.
621162|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received relaxation meditation as the attention control condition
621163|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
621164|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention, but rather care as usual.
621165|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control.
621166|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook Intervention
621167|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants did not receive any intervention but rather care as usual.
621168|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as the attention control condition
621169|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
621170|NCT01044290|O3|Outcome|Arm 3 Usual Care|Participants did not receive any intervention but rather care as usual.
621171|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as the attention control condition.
621172|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
621173|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention but rather care as usual.
621174|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control condition.
621175|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
621176|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention, but rather care as usual
621177|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control
621178|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook Intervention
621179|NCT01044290|E3|Reported Event|Treatment as Usual|"Subjects in the third group (treatment as usual) will be exposed to no intervention or attention control during the intervention window."
621180|NCT01044290|E2|Reported Event|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD."
621181|NCT01044290|E1|Reported Event|Outlook Intervention|"Subjects in the first group (Life Completion) will complete a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
621182|NCT01044303|B1|Baseline|Mycophenolic Acid Escalation|"Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.
Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily."
621183|NCT01044303|P1|Participant Flow|Mycophenolic Acid Escalation|"Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.
Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily."
621184|NCT01044303|O3|Outcome|Renal Function|Number of patients who had stable renal function throughout the study.
621185|NCT01044303|O2|Outcome|Rate of Rejection|Number of patients who had a rejection during the course of the study.
621186|NCT01044303|O1|Outcome|Rate of Infection|Number of patients who had an infection during the course of the study.
621187|NCT01044303|O1|Outcome|Mycophenolic Acid (MPA) Escalation|Patients receiving MPA (500mg to 2500mg of CellCept daily or 360mg to 1800mg myfortic daily), cyclosporine or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 6 months
621188|NCT01044303|E1|Reported Event|Adverse Events|Adverse events reported by participants during the course of the study.
621189|NCT01044459|B3|Baseline|Total|Total of all reporting groups
621190|NCT01044459|B2|Baseline|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
621191|NCT01044459|B1|Baseline|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
621192|NCT01044459|P2|Participant Flow|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
621193|NCT01044459|P1|Participant Flow|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
621978|NCT01050543|E1|Reported Event|Sugammadex|sugammadex 2 mg/kg
621195|NCT01044459|O1|Outcome|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
621196|NCT01044459|O2|Outcome|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
621197|NCT01044459|O1|Outcome|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
621198|NCT01044459|E2|Reported Event|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
621199|NCT01044459|E1|Reported Event|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
621200|NCT01044498|B3|Baseline|Total|Total of all reporting groups
621201|NCT01044498|B2|Baseline|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
621202|NCT01044498|B1|Baseline|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621203|NCT01044498|P2|Participant Flow|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
621204|NCT01044498|P1|Participant Flow|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621205|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621206|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621242|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621207|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621208|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621209|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621210|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621211|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621212|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621213|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
621214|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621215|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
621216|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621217|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
621218|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621219|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
621220|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621221|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
621222|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621223|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
621224|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621225|NCT01044498|E2|Reported Event|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
621979|NCT01050569|B4|Baseline|Total|Total of all reporting groups
621226|NCT01044498|E1|Reported Event|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
621227|NCT01044537|B8|Baseline|Total|Total of all reporting groups
621228|NCT01044537|B7|Baseline|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
621229|NCT01044537|B6|Baseline|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621230|NCT01044537|B5|Baseline|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621231|NCT01044537|B4|Baseline|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621232|NCT01044537|B3|Baseline|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621233|NCT01044537|B2|Baseline|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621234|NCT01044537|B1|Baseline|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621235|NCT01044537|P7|Participant Flow|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
621236|NCT01044537|P6|Participant Flow|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621237|NCT01044537|P5|Participant Flow|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621238|NCT01044537|P4|Participant Flow|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621239|NCT01044537|P3|Participant Flow|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621240|NCT01044537|P2|Participant Flow|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621241|NCT01044537|P1|Participant Flow|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621243|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621244|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621245|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621246|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621247|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621248|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
621249|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621250|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621251|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621252|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621253|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621254|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621255|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
621256|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621257|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621258|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621259|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621260|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621261|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621262|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
621263|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621264|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621265|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621266|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621267|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621268|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621269|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
621270|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621271|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621980|NCT01050569|B3|Baseline|Nicotine Patch|21 mg nicotine patch
621272|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621273|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621274|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621275|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621276|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
621277|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621278|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621279|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621280|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621281|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621282|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621283|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
621284|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621285|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621286|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621287|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621288|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621289|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621290|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621291|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621292|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621293|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621294|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621295|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621296|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621297|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621298|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621299|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621300|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621301|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621302|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621303|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621304|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621305|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621306|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621307|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621308|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621309|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621310|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621311|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621312|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621313|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621314|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621315|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621316|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
623409|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
621317|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621318|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621319|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621320|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621321|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621322|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621323|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621324|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621325|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621326|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
621327|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621328|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621329|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621330|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621331|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621332|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621333|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
621334|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621335|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621336|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621337|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621338|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621339|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621340|NCT01044537|E7|Reported Event|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
621341|NCT01044537|E6|Reported Event|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
621342|NCT01044537|E5|Reported Event|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
621343|NCT01044537|E4|Reported Event|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
621344|NCT01044537|E3|Reported Event|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
621345|NCT01044537|E2|Reported Event|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
621346|NCT01044537|E1|Reported Event|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
621347|NCT01044589|B3|Baseline|Total|Total of all reporting groups
621348|NCT01044589|B2|Baseline|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
621349|NCT01044589|B1|Baseline|Overlapping Sphincter Repair|"Control
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
621350|NCT01044589|P2|Participant Flow|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
621351|NCT01044589|P1|Participant Flow|Overlapping Sphincter Repair|"Control
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
621352|NCT01044589|O2|Outcome|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
621353|NCT01044589|O1|Outcome|Overlapping Sphincter Repair|"Control
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
621354|NCT01044589|O2|Outcome|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
621355|NCT01044589|O1|Outcome|Overlapping Sphincter Repair|"Control
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
621356|NCT01044589|E2|Reported Event|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
621357|NCT01044589|E1|Reported Event|Overlapping Sphincter Repair|"Control
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
621358|NCT01044693|B1|Baseline|All Study Participants|Participants who were randomized to receive placebo, metoprolol, sildenafil and nebivolol in any order
621359|NCT01044693|P16|Participant Flow|Placebo Then Nebivolol Then Sildenafil Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621449|NCT01044758|E4|Reported Event|aMCI_125 Placebo|125 mg placebo comparator (placebo capsule twice daily for two weeks)
621360|NCT01044693|P15|Participant Flow|Nebivolol Then Placebo Then Sildenafil Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621361|NCT01044693|P14|Participant Flow|Nebivolol Then Sildenafil Then Metoprolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621362|NCT01044693|P13|Participant Flow|Sildenafil Then Metoprolol Then Nebivolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621363|NCT01044693|P12|Participant Flow|Sildenafil Then Nebivolol Then Metoprolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621364|NCT01044693|P11|Participant Flow|Metoprolol Then Sildenafil Then Nebivolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621365|NCT01044693|P10|Participant Flow|Metoprolol Then Nebivolol Then Placebo Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621366|NCT01044693|P9|Participant Flow|Nebivolol Then Metoprolol Then Sildenafil Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621367|NCT01044693|P8|Participant Flow|Metoprolol Then Placebo Then Nebivolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621368|NCT01044693|P7|Participant Flow|Sildenafil Then Nebivolol Then Placebo Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621369|NCT01044693|P6|Participant Flow|Metoprolol Then Sildenafil Then Placebo Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621370|NCT01044693|P5|Participant Flow|Nebivolol Then Placebo Then Metoprolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621371|NCT01044693|P4|Participant Flow|Placebo Then Sildenafil Then Metoprolol Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621372|NCT01044693|P3|Participant Flow|Placebo Then Sildenafil Then Nebivolol Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621373|NCT01044693|P2|Participant Flow|Placebo Then Nebivolol Then Metoprolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621374|NCT01044693|P1|Participant Flow|Placebo Then Metoprolol Then Sildenafil Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
621375|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose
Sildenafil25 mg: Sildenafil 25 mg single oral dose"
627973|NCT01059760|O1|Outcome|Baseline Value|
621376|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose
metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
621377|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule
Nebivolol 5 mg: Nebivolol 5mg single oral dose"
621378|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo: Placebo capsule"
621379|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose
Sildenafil25 mg: Sildenafil 25 mg single oral dose"
621380|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose
metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
621381|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule
Nebivolol 5 mg: Nebivolol 5mg single oral dose"
621382|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo: Placebo capsule"
621383|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose
Sildenafil25 mg: Sildenafil 25 mg single oral dose"
621384|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose
metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
621385|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule
Nebivolol 5 mg: Nebivolol 5mg single oral dose"
621386|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo: Placebo capsule"
621387|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose
Sildenafil25 mg: Sildenafil 25 mg single oral dose"
621388|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose
metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
621389|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule
Nebivolol 5 mg: Nebivolol 5mg single oral dose"
621390|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule
Placebo: Placebo capsule"
621391|NCT01044693|E4|Reported Event|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose
Sildenafil25 mg: Sildenafil 25 mg single oral dose"
621392|NCT01044693|E3|Reported Event|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose
metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
621393|NCT01044693|E2|Reported Event|Nebivolol 5 mg|"Nebivolol 5 mg capsule
Nebivolol 5 mg: Nebivolol 5mg single oral dose"
621394|NCT01044693|E1|Reported Event|Placebo Capsule|"Placebo capsule
Placebo: Placebo capsule"
621395|NCT01044706|B3|Baseline|Total|Total of all reporting groups
621396|NCT01044706|B2|Baseline|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
621397|NCT01044706|B1|Baseline|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
621398|NCT01044706|P2|Participant Flow|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
621399|NCT01044706|P1|Participant Flow|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
621400|NCT01044706|O2|Outcome|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
621401|NCT01044706|O1|Outcome|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
621402|NCT01044706|O2|Outcome|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
621403|NCT01044706|O1|Outcome|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
621404|NCT01044706|E2|Reported Event|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
621405|NCT01044706|E1|Reported Event|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
621406|NCT01044732|B3|Baseline|Total|Total of all reporting groups
621407|NCT01044732|B2|Baseline|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
621450|NCT01044758|E3|Reported Event|aMCI_125|125 mg levetiracetam twice daily for two weeks
621451|NCT01044758|E2|Reported Event|aMCI_62.5 Placebo|62.5 mg placebo comparator (placebo capsule twice daily for two weeks)
621408|NCT01044732|B1|Baseline|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
621409|NCT01044732|P2|Participant Flow|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
621410|NCT01044732|P1|Participant Flow|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
621411|NCT01044732|O2|Outcome|All TEC Procedures|For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during Third Eye colonoscopies (TEC)
621412|NCT01044732|O1|Outcome|All SC Procedures|For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during standard colonoscopies (SC)
621413|NCT01044732|O2|Outcome|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
621414|NCT01044732|O1|Outcome|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
621415|NCT01044732|E2|Reported Event|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
621416|NCT01044732|E1|Reported Event|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)
Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
621417|NCT01044758|B8|Baseline|Total|Total of all reporting groups
621418|NCT01044758|B7|Baseline|Control_Placebo First, Then Placebo|"Healthy control
placebo capsule twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
621419|NCT01044758|B6|Baseline|aMCI_Placebo First, Then 250mg Drug|"Amnestic MCI:
Placebo capsule twice daily (two weeks), washout (4 weeks), and 250mg levetiracetam twice daily (two weeks)"
621420|NCT01044758|B5|Baseline|aMCI_250mg Drug First, Then Placebo|"Amnestic MCI:
250mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
622564|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
621421|NCT01044758|B4|Baseline|aMCI_Placebo First, Then 125mg Drug|"Amnestic MCI:
Placebo capsule twice daily (two weeks), washout (4 weeks), and 125mg levetiracetam twice daily (two weeks)"
621422|NCT01044758|B3|Baseline|aMCI_125mg Drug First, Then Placebo|"Amnestic MCI:
125mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
621423|NCT01044758|B2|Baseline|aMCI_Placebo First, Then 62.5mg Drug|"Amnestic MCI:
Placebo capsule twice daily (two weeks), washout (4 weeks), and 62.5mg levetiracetam twice daily (two weeks)"
621424|NCT01044758|B1|Baseline|aMCI_62.5mg Drug First, Then Placebo|"Amnestic MCI:
62.5mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
621425|NCT01044758|P7|Participant Flow|Control_Placebo First, Then Placebo|"Healthy control:
placebo capsule twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
621426|NCT01044758|P6|Participant Flow|aMCI_Placebo First, Then 250mg Drug|"Amnestic MCI:
Placebo capsule twice daily (two weeks), washout (4 weeks), and 250mg levetiracetam twice daily (two weeks)"
621427|NCT01044758|P5|Participant Flow|aMCI_250mg Drug First, Then Placebo|"Amnestic MCI:
250mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
621428|NCT01044758|P4|Participant Flow|aMCI_Placebo First, Then 125mg Drug|"Amnestic MCI:
Placebo capsule twice daily (two weeks), washout (4 weeks), and 125mg levetiracetam twice daily (two weeks)"
621429|NCT01044758|P3|Participant Flow|aMCI_125mg Drug First, Then Placebo|"Amnestic MCI:
125mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
621430|NCT01044758|P2|Participant Flow|aMCI_Placebo First, Then 62.5mg Drug|"Amnestic MCI:
Placebo capsule twice daily (two weeks), washout (4 weeks), and 62.5mg levetiracetam twice daily (two weeks)"
621431|NCT01044758|P1|Participant Flow|aMCI_62.5mg Drug First, Then Placebo|"Amnestic MCI:
62.5mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
621432|NCT01044758|O7|Outcome|Age Matched Control|Placebo capsule twice daily for two weeks
621433|NCT01044758|O6|Outcome|aMCI_250 Placebo|250mg levetiracetam placebo comparator
621434|NCT01044758|O5|Outcome|aMCI_250|250mg levetiracetam twice daily for two weeks
621435|NCT01044758|O4|Outcome|aMCI_125 Placebo|125mg levetiracetam placebo comparator
621436|NCT01044758|O3|Outcome|aMCI_125|125mg levetiracetam twice daily for two weeks
621437|NCT01044758|O2|Outcome|aMCI_62.5 Placebo|62.6mg levetiracetam placebo comparator
621438|NCT01044758|O1|Outcome|aMCI_62.5|62.5mg levetiracetam twice daily for two weeks
621439|NCT01044758|O7|Outcome|Age Matched Control|Placebo capsule twice daily for two weeks
621440|NCT01044758|O6|Outcome|aMCI_250 Placebo|250mg levetiracetam placebo comparator
621441|NCT01044758|O5|Outcome|aMCI_250|250mg levetiracetam twice daily for two weeks
621442|NCT01044758|O4|Outcome|aMCI_125 Placebo|125mg levetiracetam placebo comparator
621443|NCT01044758|O3|Outcome|aMCI_125|125 mg Levetiracetam twice daily for two weeks.
621444|NCT01044758|O2|Outcome|aMCI_62.5 Placebo|62.5mg levetiracetam placebo comparator
621445|NCT01044758|O1|Outcome|aMCI_62.5|62.5 mg levetiracetam twice daily for two weeks
621446|NCT01044758|E7|Reported Event|Age Matched Control|placebo capsule twice daily for two weeks
621447|NCT01044758|E6|Reported Event|aMCI_250 Placebo|250 mg placebo comparator (placebo capsule twice daily for two weeks)
621448|NCT01044758|E5|Reported Event|aMCI_250|250 mg levetiracetam twice daily for two weeks
621453|NCT01044771|B1|Baseline|Change From Tenofovir to Raltegravir|"Single arm study:
Tenofovir containing nucleoside backbone changed over to raltegravir in all patients"
621454|NCT01044771|P1|Participant Flow|Change From Tenofovir to Raltegravir|"Single arm study:
Tenofovir containing nucleoside backbone changed over to raltegravir in all patients Tenovovir 300mg was replaced with Raltegravir 400mg twice a day"
621455|NCT01044771|O1|Outcome|Viral Rebound|Every participant in the study switched to the investigational strategy
621456|NCT01044771|O1|Outcome|Change From Tenofovir to Raltegravir|"Single arm study:
Tenofovir containing nucleoside backbone changed over to raltegravir in all patients
change from tenofovir to raltegravir: Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID"
621457|NCT01044771|E1|Reported Event|Change From Tenofovir to Raltegravir|"Single arm study:
Tenofovir containing nucleoside backbone changed over to raltegravir in all patients"
621458|NCT01044862|B4|Baseline|Total|Total of all reporting groups
621459|NCT01044862|B3|Baseline|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
621460|NCT01044862|B2|Baseline|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
621461|NCT01044862|B1|Baseline|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
627974|NCT01059760|O3|Outcome|Change When Fed|
621462|NCT01044862|P3|Participant Flow|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
621463|NCT01044862|P2|Participant Flow|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
621464|NCT01044862|P1|Participant Flow|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
621465|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
621466|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
621467|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
621468|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
621469|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
621486|NCT01045031|O1|Outcome|Controls|Controls were subsequently contacted via personal contact and three additional advertisements (two in an Austrian newspaper (“Krone”) and one in an Austrian bicyclist journal (“Bicyclist Sports”). The controls were matched according to age, sex and years of education
621470|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
621471|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
621472|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
621473|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
621474|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
621504|NCT01045096|P3|Participant Flow|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
622565|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
621475|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
621476|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
621477|NCT01044862|E3|Reported Event|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
621478|NCT01044862|E2|Reported Event|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
621479|NCT01044862|E1|Reported Event|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
621480|NCT01045031|B3|Baseline|Total|Total of all reporting groups
621481|NCT01045031|B2|Baseline|Controls|The control group was matched according to age, sex and years of education.
621482|NCT01045031|B1|Baseline|Marathon Athletes|Participation in more than one of the following competitions during the previous three years: Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km)
621483|NCT01045031|P2|Participant Flow|Marathon Athletes|"Runners and bicyclists participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km) were recruited.
The inclusion criteria were
(1) participation in at least one of these 3 marathons in the preceding two years, (2) were still in continuous training during the recruitment phase (at least 2 hours/week) and (3) were over the age of 60."
621484|NCT01045031|P1|Participant Flow|Controls|The control group was matched according to age, sex and years of education.
621485|NCT01045031|O2|Outcome|Marathon Athletes|Runners participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km). Inclusion criteria:1) participation in at least one of these 3 marathons in the preceding two years,2)still in continuous training during the recruitment phase (at least 2 hours/week), 3) aged over 60. Exclusion criteria:(a) present or past exposure to neurotoxic substances (b) if they did not speak German as their native language (c) diseases that markedly affect CNS functions (d) manifest cardiovascular disease, (e) chronic alcoholism (daily alcohol intake > 60 g or diagnosed history of alcoholism) and (f) unwillingness to give informed consent.
621487|NCT01045031|O2|Outcome|Marathon Athletes|"Runners and bicyclists participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km) were recruited.
The inclusion criteria were
(1) participation in at least one of these 3 marathons in the preceding two years, (2) were still in continuous training during the recruitment phase (at least 2 hours/week) and (3) were over the age of 60."
621488|NCT01045031|O1|Outcome|Controls|The control group was matched according to age, sex and years of education.
621489|NCT01045031|O2|Outcome|Controls|Brain-derived Neurotrophic Factor (BDNF)
621490|NCT01045031|O1|Outcome|Marathon Athletes|Brain-derived Neurotrophic Factor (BDNF)
621491|NCT01045031|E2|Reported Event|Athletes|
621492|NCT01045031|E1|Reported Event|Controls|
621493|NCT01045057|B1|Baseline|Provox Vega Puncture Set|Group of larynx cancer patients undergoing a total laryngectomy whereby the puncture and placement of the voice prosthesis is done with the Provox Vega Puncture Set
621494|NCT01045057|P1|Participant Flow|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Vega Puncture Set
621495|NCT01045057|O1|Outcome|Secondary Puncture|Patients who had a secondary puncture
621496|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
621497|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
621498|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
621499|NCT01045057|E1|Reported Event|Provox Vega Puncture Set|Group of larynx cancer patients undergoing laryngectomy whereby the puncture and the placement of the voice prosthesis is done with the Provox Vega Puncture set
621500|NCT01045096|B4|Baseline|Total|Total of all reporting groups
621501|NCT01045096|B3|Baseline|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
621502|NCT01045096|B2|Baseline|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
621503|NCT01045096|B1|Baseline|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
621842|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
621505|NCT01045096|P2|Participant Flow|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
621506|NCT01045096|P1|Participant Flow|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
621507|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
621508|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
621509|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
621510|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
621511|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
621512|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
621513|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
621514|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
621515|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
621516|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
621517|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
621518|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
621519|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
621520|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
621521|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
621522|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
621523|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
621524|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
621525|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
621526|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
621527|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
621528|NCT01045096|E3|Reported Event|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
621529|NCT01045096|E2|Reported Event|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
621530|NCT01045096|E1|Reported Event|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
621531|NCT01045122|B1|Baseline|Propofol vs Dexmedetomidine|We aim to study two commonly used sedatives (propofol vs dexmedetomidine) in subjects with OSA for their propensity to produce sedation related respiratory events
621532|NCT01045122|P2|Participant Flow|Dexmedetomidine First|Dexmedetomidine was administered on the first day in 6/11 subjects with at least a one week washout between runs before the subjects underwent the experiment with propofol.
621533|NCT01045122|P1|Participant Flow|Propofol First|Propofol was administered first in 5/11 subjects with a one week washout at least between the next run with dexmedetomidine
621534|NCT01045122|O2|Outcome|Dexmedetomidine|The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms
621535|NCT01045122|O1|Outcome|Propofol|The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms
621536|NCT01045122|E2|Reported Event|Dexmedetomidine|"Dexmedetomidine is an alpha-2 adrenoreceptor agonist that has sedative, hypnotic, and analgesic effects.
Dexmedetomidine: For dexmedetomidine, an intravenous loading dose of 0.5 mcg/kg will be infused over 10 minutes and followed by an infusion starting at 0.5 mcg/kg/hr. This infusion will be titrated up to a maximum of 1.2 mcg/kg/hr."
621537|NCT01045122|E1|Reported Event|Propofol|"Is an alkylphenol, is primarily indicated for use as a general anesthetic and has minimal analgesic properties.
Propofol: For propofol, the current study will employ the Marsh parameters, with an initial effect site target concentration of 1.0 mcg/ml, a level likely to produce only mild sedation. Though our patient population is expected to be predominantly obese, a previous pharmacokinetic study has validated that constant infusions utilizing the dosing scheme of mcg-1•kg-1•min will yield similar effect site concentrations.25 The effect site target will be increased in increments approximately every five minutes until the pharmacodynamic targets defined in the study are attained."
621538|NCT01045161|B4|Baseline|Total|Total of all reporting groups
621539|NCT01045161|B3|Baseline|Aclidinium Bromide(AB) 400μg Part A / AB 400μg to 400μg Part B|"Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment in Part A of the Trial.
After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks."
621540|NCT01045161|B2|Baseline|Aclidinium Bromide(AB) 200μg Part A / AB 200μg to 400μg Part B|"Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment in Part A of the Trial.
After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks."
621684|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.
Apremilast: 20mg taken orally twice per day for 12 weeks"
621541|NCT01045161|B1|Baseline|Placebo Part A / Placebo to Aclidinium Bromide 400μg Part B|"Dose-matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment in Part A of the Trial.
After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks."
621542|NCT01045161|P3|Participant Flow|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients continued to receive Aclidinium bromide, 400 microgram dose as an open-label treatment for an additional 40 weeks
621543|NCT01045161|P2|Participant Flow|Aclidinium Bromide 200μg to Aclidinium Bromide 400μg|Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients who were Aclidinium bromide 200 microgram dose, received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
621544|NCT01045161|P1|Participant Flow|Placebo - Part A Placebo to Aclidinium Bromide 400 μg - Part B|Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment. After 12 weeks, patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
621545|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide 400 μg dose, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg switched to open label 400µg aclidinium bromide for 40 weeks
621546|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg|Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg switched to open label 400µg aclidinium bromide for 40 weeks
621547|NCT01045161|O1|Outcome|Placebo - Aclidinium Bromide 400 μg|Dose matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo switched to open label 400µg aclidinium bromide for 40 weeks
621548|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients received open label 400µg aclidinium bromide for 40 additional weeks
621549|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 200 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg were switched to open label 400µg aclidinium bromide for 40 weeks.
621550|NCT01045161|O1|Outcome|Placebo - Aclidinium Bromide 400 μg|Dose matched placebo, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on placebo were switched to open label 400µg aclidinium bromide for 40 weeks
621551|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg|Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.
621552|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg|Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.
621553|NCT01045161|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.
621554|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg|Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.
621555|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg|Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.
621556|NCT01045161|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.
621557|NCT01045161|E6|Reported Event|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg - Part B|After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks.
621558|NCT01045161|E5|Reported Event|Aclidinium Bromide 200μg to Aclidinium Bromide 400μg - Part B|Part B - After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks.
623410|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
621559|NCT01045161|E4|Reported Event|Placebo to Aclidinium Bromide 400 μg - Part B|After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
621560|NCT01045161|E3|Reported Event|Aclidinium Bromide 400 μg - Part A|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment.
621561|NCT01045161|E2|Reported Event|Aclidinium Bromide 200 μg - Part A|Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment.
621562|NCT01045161|E1|Reported Event|Placebo - Part A|Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment.
621563|NCT01045187|B1|Baseline|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
621564|NCT01045187|P1|Participant Flow|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
621565|NCT01045187|O1|Outcome|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
621566|NCT01045187|E1|Reported Event|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
621567|NCT01045265|B1|Baseline|Men on Raltegravir|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
621568|NCT01045265|P1|Participant Flow|Men on Raltegravir|HIV-infected men on chronic therapy with raltegravir 400 mg per day as part of antiretroviral therapy regimen.
621569|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
621570|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
621685|NCT01045551|O1|Outcome|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.
Apremilast: 20mg taken orally twice per day for 12 weeks"
627975|NCT01059760|O2|Outcome|Change While Fasting|
621571|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
621572|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
621573|NCT01045265|E1|Reported Event|Men on Raltegravir|HIV-infected men receiving chronic therapy with raltegravir 400 mg per day as part of antiretroviral regimen.
621574|NCT01045421|B7|Baseline|Total|Total of all reporting groups
621575|NCT01045421|B6|Baseline|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
621576|NCT01045421|B5|Baseline|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
621577|NCT01045421|B4|Baseline|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
621578|NCT01045421|B3|Baseline|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
621579|NCT01045421|B2|Baseline|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
621580|NCT01045421|B1|Baseline|Phase 1: MLN8237- All Participants|MLN8237 (alisertib) 10, 20, 30, 40, 50, or 60 mg enteric-coated tablets, orally, twice daily, for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants enrolled in dose-escalation or pancreatic cancer cohort during Phase 1 portion of the study.
621581|NCT01045421|P11|Participant Flow|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
621582|NCT01045421|P10|Participant Flow|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
621583|NCT01045421|P9|Participant Flow|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
621584|NCT01045421|P8|Participant Flow|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
621585|NCT01045421|P7|Participant Flow|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
621586|NCT01045421|P6|Participant Flow|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
621587|NCT01045421|P5|Participant Flow|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621588|NCT01045421|P4|Participant Flow|Phase 1: MLN8237 50 mg|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621589|NCT01045421|P3|Participant Flow|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621590|NCT01045421|P2|Participant Flow|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621591|NCT01045421|P1|Participant Flow|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621592|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
621593|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
621594|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
621595|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
621596|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
621597|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621598|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
621599|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621694|NCT01045707|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
621600|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621601|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621602|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621603|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
621604|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621605|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621606|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621607|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621608|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
621609|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621610|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621611|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621612|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621613|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
621614|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621615|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621616|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621617|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621772|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621618|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
621619|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621620|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621621|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621622|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621623|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
621624|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621625|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621626|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621627|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621628|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
621629|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621630|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621631|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621632|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
621633|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
621634|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
621695|NCT01045707|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
621635|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
621636|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
621637|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
621638|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
621639|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
621640|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
621641|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
621642|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
621686|NCT01045551|O1|Outcome|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.
Apremilast: 20mg taken orally twice per day for 12 weeks"
621643|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
621644|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
621645|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
621646|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
621647|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
621648|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
621649|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
621650|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
621696|NCT01045707|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
621651|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
621652|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
621653|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
621654|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
621655|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
621656|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
621657|NCT01045421|O6|Outcome|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
621658|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621659|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621745|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621660|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621661|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621662|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
621663|NCT01045421|E7|Reported Event|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
621664|NCT01045421|E6|Reported Event|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
621665|NCT01045421|E5|Reported Event|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
621666|NCT01045421|E4|Reported Event|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
621667|NCT01045421|E3|Reported Event|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
621819|NCT01049984|P1|Participant Flow|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
621668|NCT01045421|E2|Reported Event|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
621669|NCT01045421|E1|Reported Event|Phase 1: MLN8237- Dose Escalation|MLN8237 (alisertib) 10, 20, 30, 40, 50, or 60 mg enteric-coated tablets, orally, twice daily, for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants enrolled in dose escalation cohort during Phase 1 portion of the study.
621670|NCT01045447|B3|Baseline|Total|Total of all reporting groups
621671|NCT01045447|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
621672|NCT01045447|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
621673|NCT01045447|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
621674|NCT01045447|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
621675|NCT01045447|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
621676|NCT01045447|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
621677|NCT01045447|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
621678|NCT01045447|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
621679|NCT01045447|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
621680|NCT01045447|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
621681|NCT01045551|B1|Baseline|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.
Apremilast: 20mg taken orally twice per day for 12 weeks"
621682|NCT01045551|P1|Participant Flow|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.
Apremilast: 20mg taken orally twice per day for 12 weeks"
621683|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.
Apremilast: 20mg taken orally twice per day for 12 weeks"
621791|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621687|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.
Apremilast: 20mg taken orally twice per day for 12 weeks"
621688|NCT01045551|E1|Reported Event|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.
Apremilast: 20mg taken orally twice per day for 12 weeks
The most frequently reported adverse event (AE) was infection. One patient (a 74 year old female) experienced 2 urinary tract infections during the course of the study, and another (a 63 year old female) experienced one urinary tract infection. Two patients experienced upper respiratory infections, which have previously been reported in patients taking apremilast. The second most common AE was loose stool, reported by two patients, which resolved quickly and without recurrence. All AE’s were reported as mild and no patient withdrew from the study due to AEs. No patient required dosing modification or discontinuation."
621689|NCT01045694|B1|Baseline|Arthritis Treatment|"Participants received one of three treatments:
Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule
Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution"
621690|NCT01045694|P1|Participant Flow|Arthritis Treatment|"Participants received one of three treatments:
Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule
Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution"
621691|NCT01045694|O1|Outcome|Arthritis Treatment|"Participants received one of three treatments:
Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule
Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution"
621692|NCT01045694|E1|Reported Event|Arthritis Treatment|"Participants received one of three treatments:
Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule
Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group."
621693|NCT01045707|B3|Baseline|Total|Total of all reporting groups
621724|NCT01045967|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
621697|NCT01045707|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
621698|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
621699|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
621700|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
621701|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
621702|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
621703|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
621704|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
621705|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
621706|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
622566|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
621707|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
621708|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
621709|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
621710|NCT01045707|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
621711|NCT01045707|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
621712|NCT01045798|B3|Baseline|Total|Total of all reporting groups
621713|NCT01045798|B2|Baseline|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
621714|NCT01045798|B1|Baseline|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
621715|NCT01045798|P2|Participant Flow|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
621716|NCT01045798|P1|Participant Flow|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
621717|NCT01045798|O2|Outcome|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
621718|NCT01045798|O1|Outcome|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
621719|NCT01045798|E2|Reported Event|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
621720|NCT01045798|E1|Reported Event|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
621721|NCT01045967|B3|Baseline|Total|Total of all reporting groups
621722|NCT01045967|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
621723|NCT01045967|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
621725|NCT01045967|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
621726|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
621727|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
621728|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
621729|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
621730|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
621731|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
621732|NCT01045967|E2|Reported Event|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
621733|NCT01045967|E1|Reported Event|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
621734|NCT01045993|B5|Baseline|Total|Total of all reporting groups
621735|NCT01045993|B4|Baseline|Oral Placebo|Oral Placebo matching Oral IBU.
621736|NCT01045993|B3|Baseline|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621737|NCT01045993|B2|Baseline|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621738|NCT01045993|B1|Baseline|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621739|NCT01045993|P4|Participant Flow|Oral Placebo|Oral Placebo matching Oral IBU.
621740|NCT01045993|P3|Participant Flow|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621741|NCT01045993|P2|Participant Flow|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621742|NCT01045993|P1|Participant Flow|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621743|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621744|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
622567|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
621746|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621747|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621748|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621749|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621750|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621751|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621752|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621753|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621754|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621755|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621756|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621757|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621758|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621759|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621760|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621761|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621762|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621763|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621764|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621765|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621766|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621767|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621768|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621769|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621770|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621771|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621773|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621774|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621775|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621776|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621777|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621778|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621779|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621780|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621781|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621782|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621783|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621784|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621785|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621786|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621787|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621788|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621789|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621790|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621792|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621793|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621794|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621795|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621796|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621797|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621798|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621799|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621800|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621801|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621802|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621803|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621804|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621805|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621806|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621807|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
621808|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621809|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621810|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621811|NCT01045993|E4|Reported Event|Oral Placebo|Oral Placebo matching Oral IBU.
621812|NCT01045993|E3|Reported Event|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
621813|NCT01045993|E2|Reported Event|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
621814|NCT01045993|E1|Reported Event|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
621815|NCT01049984|B3|Baseline|Total|Total of all reporting groups
621816|NCT01049984|B2|Baseline|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
621817|NCT01049984|B1|Baseline|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
621818|NCT01049984|P2|Participant Flow|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
621821|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
621822|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
621823|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
621824|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
621825|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
621826|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
621827|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
621828|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
621829|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
621830|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
621831|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
621832|NCT01049984|E2|Reported Event|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
621833|NCT01049984|E1|Reported Event|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
621834|NCT01050062|B3|Baseline|Total|Total of all reporting groups
621835|NCT01050062|B2|Baseline|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
621836|NCT01050062|B1|Baseline|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
621837|NCT01050062|P2|Participant Flow|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
621838|NCT01050062|P1|Participant Flow|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
621839|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
621840|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
621841|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
621843|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
621844|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
621845|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
621846|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
621847|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
621848|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
621849|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
621850|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
621851|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
621852|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
621853|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
621854|NCT01050062|E3|Reported Event|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
621855|NCT01050062|E2|Reported Event|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
621856|NCT01050062|E1|Reported Event|Combination Tablet Ap|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
621857|NCT01050153|B3|Baseline|Total|Total of all reporting groups
621858|NCT01050153|B2|Baseline|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621859|NCT01050153|B1|Baseline|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
621860|NCT01050153|P2|Participant Flow|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621861|NCT01050153|P1|Participant Flow|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
621862|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621863|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
621864|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621865|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
621866|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621867|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
623411|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
621868|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621869|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
621870|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621871|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
621872|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621873|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
621874|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621875|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
621876|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621877|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
621878|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621879|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
627976|NCT01059760|O1|Outcome|Baseline Value|
621880|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621881|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
621882|NCT01050153|E2|Reported Event|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm
Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
621883|NCT01050153|E1|Reported Event|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily
Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
621884|NCT01050205|B3|Baseline|Total|Total of all reporting groups
621885|NCT01050205|B2|Baseline|Delayed Intervention|"At enrollment, participants are randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621886|NCT01050205|B1|Baseline|Current Intervention|"At enrollment, participants are randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621887|NCT01050205|P2|Participant Flow|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621930|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
623412|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
621888|NCT01050205|P1|Participant Flow|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621889|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621890|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621921|NCT01050257|B2|Baseline|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621999|NCT01050569|E2|Reported Event|VLNC Cigarette Plus Nicotine Patch|VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
627977|NCT01059760|O3|Outcome|Change When Fed|
621891|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621892|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621893|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621894|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621972|NCT01050543|B1|Baseline|Sugammadex|sugammadex 2 mg/kg
621973|NCT01050543|P2|Participant Flow|Neostigmine|neostigmine 50 mcg/kg
621895|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621896|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621897|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621898|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621899|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621900|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621901|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621902|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621903|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621904|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621905|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621906|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621907|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621908|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621909|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621910|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621911|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621912|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
621913|NCT01050205|E2|Reported Event|Delayed Intervention|No unexpected or unanticipated adverse events occurred in the Delayed Intervention group.
621914|NCT01050205|E1|Reported Event|Current Intervention|No unexpected or unanticipated adverse events occurred in the Current Intervention group.
621915|NCT01050218|B1|Baseline|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
621916|NCT01050218|P1|Participant Flow|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
621917|NCT01050218|O1|Outcome|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
621918|NCT01050218|E1|Reported Event|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
621919|NCT01050257|B4|Baseline|Total|Total of all reporting groups
621920|NCT01050257|B3|Baseline|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621995|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
621996|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
621922|NCT01050257|B1|Baseline|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621923|NCT01050257|P3|Participant Flow|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621924|NCT01050257|P2|Participant Flow|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621925|NCT01050257|P1|Participant Flow|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621926|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621927|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621928|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621929|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621974|NCT01050543|P1|Participant Flow|Sugammadex|sugammadex 2 mg/kg
621931|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621932|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621933|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621934|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621935|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621936|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621937|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
627978|NCT01059760|O2|Outcome|Change While Fasting|
621938|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621939|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621940|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621941|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621942|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621943|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621944|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621945|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621946|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621947|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621948|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621949|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621950|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621951|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621952|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621953|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621997|NCT01050569|O1|Outcome|VLNC Cigarette|VLNC Cigarettes: Cigarette where the tobacco contains <0.1 mg nicotine yield.
621998|NCT01050569|E3|Reported Event|Nicotine Patch|21 mg nicotine patch
621954|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621955|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621956|NCT01050257|E3|Reported Event|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
621957|NCT01050257|E2|Reported Event|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621958|NCT01050257|E1|Reported Event|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
621959|NCT01050530|B3|Baseline|Total|Total of all reporting groups
621960|NCT01050530|B2|Baseline|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
621961|NCT01050530|B1|Baseline|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
621962|NCT01050530|P2|Participant Flow|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
621963|NCT01050530|P1|Participant Flow|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
621964|NCT01050530|O2|Outcome|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
621965|NCT01050530|O1|Outcome|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
621966|NCT01050530|O2|Outcome|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
621967|NCT01050530|O1|Outcome|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
621968|NCT01050530|E2|Reported Event|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
621969|NCT01050530|E1|Reported Event|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
621970|NCT01050543|B3|Baseline|Total|Total of all reporting groups
621971|NCT01050543|B2|Baseline|Neostigmine|neostigmine 50 mcg/kg
621981|NCT01050569|B2|Baseline|VLNC Cigarette Plus Nicotine Patch|VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
621982|NCT01050569|B1|Baseline|VLNC Cigarette|Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield.
621983|NCT01050569|P3|Participant Flow|Nicotine Patch|Nicotine Patch: 21 mg. Nicotine patch was administered on a daily basis for a period of 6 weeks.
621984|NCT01050569|P2|Participant Flow|VLNC Cigarette Plus Nicotine Patch|Very Low Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield. Nicotine patch was administered on a daily basis. Participants were asked to use experimental cigarettes on an ad lib basis. Products were used for 6 weeks.
621985|NCT01050569|P1|Participant Flow|VLNC Cigarette|Very Low Nicotine Content Cigarette: Cigarette where the tobacco contains <0.1 mg of nicotine yield. Participants were asked to smoke experimental cigarettes in an ad lib basis. Product was used for 6 weeks.
621986|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
621987|NCT01050569|O2|Outcome|VLNC Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
621988|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
621989|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
621990|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch : 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
621991|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
621992|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
621993|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
621994|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
622000|NCT01050569|E1|Reported Event|VLNC Cigarette|Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield.
622001|NCT01050582|B3|Baseline|Total|Total of all reporting groups
622002|NCT01050582|B2|Baseline|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
622003|NCT01050582|B1|Baseline|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
622004|NCT01050582|P2|Participant Flow|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
622005|NCT01050582|P1|Participant Flow|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
622006|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
622007|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
622008|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
622009|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
622010|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
622011|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
622012|NCT01050582|E2|Reported Event|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
622013|NCT01050582|E1|Reported Event|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
622014|NCT01050634|B1|Baseline|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
622015|NCT01050634|P1|Participant Flow|Aromasin (Exemestane)|The recommended dosage of exemestane was 25mg once a day.
622016|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
622017|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
622018|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
622019|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
622020|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
622021|NCT01050634|E1|Reported Event|Observational|
622022|NCT01050660|B3|Baseline|Total|Total of all reporting groups
622023|NCT01050660|B2|Baseline|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622024|NCT01050660|B1|Baseline|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622025|NCT01050660|P2|Participant Flow|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622026|NCT01050660|P1|Participant Flow|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622027|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622028|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622029|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622030|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622031|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622032|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622033|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622568|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
622034|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622035|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622036|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622037|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622038|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622039|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622040|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622041|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622042|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622043|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622044|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622045|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622046|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622047|NCT01050660|E2|Reported Event|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d: Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
622048|NCT01050660|E1|Reported Event|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion: An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
622049|NCT01050673|B3|Baseline|Total|Total of all reporting groups
622113|NCT01050998|B2|Baseline|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622050|NCT01050673|B2|Baseline|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622051|NCT01050673|B1|Baseline|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622052|NCT01050673|P2|Participant Flow|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622053|NCT01050673|P1|Participant Flow|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622054|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622055|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622056|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622057|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622058|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622059|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622060|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622061|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622125|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622062|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622063|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622064|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622065|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622066|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622067|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622068|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622069|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622070|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622071|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622072|NCT01050673|E2|Reported Event|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
622073|NCT01050673|E1|Reported Event|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
622074|NCT01050764|B1|Baseline|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
622075|NCT01050764|P1|Participant Flow|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
622076|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
622077|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
622078|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
622079|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
622776|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
622080|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
622081|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
622082|NCT01050764|E1|Reported Event|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
622083|NCT01050790|B1|Baseline|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
622084|NCT01050790|P1|Participant Flow|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
622085|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days
lenalidomide: 10 mg p.o. daily, Days 6-21"
622126|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622086|NCT01050790|O1|Outcome|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
622087|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days
lenalidomide: 10 mg p.o. daily, Days 6-21"
622088|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days
lenalidomide: 10 mg p.o. daily, Days 6-21"
622089|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days
lenalidomide: 10 mg p.o. daily, Days 6-21"
622090|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days
lenalidomide: 10 mg p.o. daily, Days 6-21"
622091|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days
lenalidomide: 10 mg p.o. daily, Days 6-21"
622092|NCT01050790|E1|Reported Event|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days
lenalidomide: 10 mg p.o. daily, Days 6-21"
622093|NCT01050816|B1|Baseline|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
622094|NCT01050816|P1|Participant Flow|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
622095|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
622096|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
622097|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
622098|NCT01050816|E1|Reported Event|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
622099|NCT01050946|B1|Baseline|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the precondition regimen at discretion of treating physician.
Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.
Conditioning Regimens Choice of regimen at the discretion of the treating physician
Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)
Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
623413|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
622100|NCT01050946|P1|Participant Flow|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.
Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.
Conditioning Regimens Choice of regimen at the discretion of the treating physician
Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)
Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
622101|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.
Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.
Conditioning Regimens Choice of regimen at the discretion of the treating physician
Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)
Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
622102|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.
Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.
Conditioning Regimens Choice of regimen at the discretion of the treating physician
Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)
Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
622103|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.
Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.
Conditioning Regimens Choice of regimen at the discretion of the treating physician
Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)
Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
622569|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
622104|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.
Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.
Conditioning Regimens Choice of regimen at the discretion of the treating physician
Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)
Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
622105|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.
Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.
Conditioning Regimens Choice of regimen at the discretion of the treating physician
Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)
Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
622106|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.
Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.
Conditioning Regimens Choice of regimen at the discretion of the treating physician
Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)
Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
622107|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the precondition regimen at discretion of treating physician.
Haploidentical/cord transplant: Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.
Conditioning Regimens Choice of regimen at the discretion of the treating physician
Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)
Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
622108|NCT01050946|E1|Reported Event|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.
Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.
Conditioning Regimens Choice of regimen at the discretion of the treating physician
Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)
Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)
Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
622109|NCT01050998|B6|Baseline|Total|Total of all reporting groups
622110|NCT01050998|B5|Baseline|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622111|NCT01050998|B4|Baseline|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622112|NCT01050998|B3|Baseline|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622114|NCT01050998|B1|Baseline|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622115|NCT01050998|P5|Participant Flow|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622116|NCT01050998|P4|Participant Flow|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622117|NCT01050998|P3|Participant Flow|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622118|NCT01050998|P2|Participant Flow|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622119|NCT01050998|P1|Participant Flow|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622120|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622121|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622122|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622123|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622124|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622570|NCT01051817|E2|Reported Event|AIN457 10mg/kg|AIN457 10mg/kg
622127|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622128|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622129|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622130|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622131|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622132|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622133|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622134|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622135|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622136|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622137|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622138|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622139|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622140|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622141|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622142|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622143|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622144|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622145|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622146|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622147|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622148|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622149|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622150|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622151|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622152|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622153|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622154|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622155|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622156|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622571|NCT01051817|E1|Reported Event|PLACEBO|PLACEBO
622572|NCT01051856|B3|Baseline|Total|Total of all reporting groups
622157|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622158|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622159|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622160|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622161|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622162|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622163|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622164|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622165|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622166|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622167|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622168|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622169|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622170|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622171|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622172|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622173|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622174|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622175|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622176|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622177|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622178|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622179|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622180|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622181|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622182|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622183|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622184|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622185|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622186|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622187|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622188|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622189|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622190|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622191|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622192|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622193|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622194|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622195|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622196|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622197|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622198|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622199|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622200|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622201|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622202|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622203|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622204|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622205|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622206|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622207|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622208|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622209|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622210|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622211|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622212|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622213|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622214|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622215|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622216|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622217|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622218|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622219|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622220|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622221|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622222|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622223|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622224|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622225|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622226|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622227|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622228|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622229|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622230|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622231|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622232|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622233|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622234|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622235|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622236|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622237|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622238|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622239|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622240|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622241|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622242|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622243|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622244|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622245|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622246|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622247|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622248|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622249|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622250|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622251|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622252|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622253|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622254|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622255|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622256|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622257|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622258|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622259|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622260|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622261|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622262|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622263|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622264|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622265|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622266|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622267|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622268|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622269|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622270|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622271|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622272|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622273|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622274|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622275|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622276|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622277|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622278|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622279|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622628|NCT01052038|E2|Reported Event|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
622280|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622281|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622282|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622283|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622284|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622285|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622286|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622287|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622288|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622289|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622290|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622291|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622292|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622293|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622294|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622295|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622296|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622297|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622298|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622299|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622300|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622301|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622302|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622303|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622304|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622305|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622306|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622307|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622308|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622309|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622629|NCT01052038|E1|Reported Event|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
622630|NCT01052077|B3|Baseline|Total|Total of all reporting groups
622310|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622311|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622312|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622313|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622314|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622315|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622316|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622317|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622318|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622319|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622320|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622321|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622322|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622323|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622324|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622325|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622326|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622327|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622328|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622329|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622330|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622331|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622332|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622333|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622334|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622335|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622336|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622337|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622338|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622339|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622631|NCT01052077|B2|Baseline|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622340|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622341|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622342|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622343|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622344|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622345|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622346|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622347|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622348|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622349|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622350|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622351|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622352|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622353|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622354|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622355|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622356|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622357|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622358|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622359|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622360|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622361|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622362|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622363|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622364|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622365|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622366|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622367|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622368|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622369|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622668|NCT01052207|B3|Baseline|Total|Total of all reporting groups
622736|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
622370|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622371|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622372|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622373|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622374|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622375|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622376|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622377|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622378|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622379|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622380|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622381|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622382|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622383|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622384|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622385|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622386|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622387|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622388|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622389|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622390|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622391|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622392|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622393|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622394|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622395|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622396|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622397|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622398|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622399|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622726|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
622727|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
622400|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622401|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622402|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622403|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622404|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622405|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622406|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622407|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622408|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622409|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622410|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622411|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622412|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622413|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622414|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622415|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622416|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622417|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622418|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622419|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622420|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622421|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622422|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622423|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622424|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622425|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622426|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622427|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622428|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622429|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622728|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
622729|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
622430|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622431|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622432|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622433|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622434|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622435|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622436|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622437|NCT01050998|E5|Reported Event|PLACEBO|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622438|NCT01050998|E4|Reported Event|CAM-3001 100 MG|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622439|NCT01050998|E3|Reported Event|CAM-3001 50 MG|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622440|NCT01050998|E2|Reported Event|CAM-3001 30 MG|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622441|NCT01050998|E1|Reported Event|CAM-3001 10 MG|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
622442|NCT01051323|B3|Baseline|Total|Total of all reporting groups
622443|NCT01051323|B2|Baseline|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622444|NCT01051323|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622445|NCT01051323|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622446|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622471|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
622447|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622448|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622449|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622450|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622451|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622452|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622453|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622454|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622455|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622730|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
622731|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
622456|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622457|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622458|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622459|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622460|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622461|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622462|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622463|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622464|NCT01051323|E2|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622465|NCT01051323|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
622466|NCT01051440|B3|Baseline|Total|Total of all reporting groups
622467|NCT01051440|B2|Baseline|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
622468|NCT01051440|B1|Baseline|Placebo|Subjects received matched placebo for lisdexamfetamine.
622469|NCT01051440|P2|Participant Flow|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
622470|NCT01051440|P1|Participant Flow|Placebo|Subjects received matched placebo for lisdexamfetamine.
622472|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
623414|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
622473|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
622474|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
622475|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
622476|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
622477|NCT01051440|E2|Reported Event|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
622478|NCT01051440|E1|Reported Event|Placebo|Subjects received matched placebo for lisdexamfetamine.
622479|NCT01051466|B3|Baseline|Total|Total of all reporting groups
622480|NCT01051466|B2|Baseline|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622481|NCT01051466|B1|Baseline|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622482|NCT01051466|P2|Participant Flow|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622508|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622737|NCT01052428|E2|Reported Event|Toprol-XL|
622483|NCT01051466|P1|Participant Flow|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622484|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622485|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom (UK) Edition (WAIS-III^UK). Healthy participants did not receive study drug.
622486|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622487|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622488|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622489|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622490|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622491|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622492|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622493|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622494|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622561|NCT01051817|B1|Baseline|AIN457|IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
622495|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622496|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622497|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622498|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622499|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622500|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622501|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622502|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622503|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622504|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622505|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622506|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622507|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622562|NCT01051817|P2|Participant Flow|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
622509|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622510|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622511|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
622512|NCT01051466|E2|Reported Event|Healthy Participants|Healthy participants: Participants were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
622513|NCT01051466|E1|Reported Event|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD) received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose.
622514|NCT01051557|B8|Baseline|Total|Total of all reporting groups
622515|NCT01051557|B7|Baseline|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622516|NCT01051557|B6|Baseline|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622517|NCT01051557|B5|Baseline|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622518|NCT01051557|B4|Baseline|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622645|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622519|NCT01051557|B3|Baseline|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622520|NCT01051557|B2|Baseline|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622521|NCT01051557|B1|Baseline|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622522|NCT01051557|P7|Participant Flow|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622523|NCT01051557|P6|Participant Flow|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622524|NCT01051557|P5|Participant Flow|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622525|NCT01051557|P4|Participant Flow|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622526|NCT01051557|P3|Participant Flow|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622527|NCT01051557|P2|Participant Flow|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622528|NCT01051557|P1|Participant Flow|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622563|NCT01051817|P1|Participant Flow|AIN457|IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
622529|NCT01051557|O1|Outcome|Treatment (Temsirolimus and Perifosine)|"PHASE I: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and perifosine PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive temsirolimus and perifosine as in phase I. Some patients may also undergo cytoreductive surgery."
622530|NCT01051557|E7|Reported Event|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622531|NCT01051557|E6|Reported Event|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622532|NCT01051557|E5|Reported Event|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622533|NCT01051557|E4|Reported Event|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622534|NCT01051557|E3|Reported Event|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622535|NCT01051557|E2|Reported Event|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622536|NCT01051557|E1|Reported Event|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
622537|NCT01051570|B1|Baseline|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle
RAD 001: 5 mg Orally daily, starting from Day 2 continuously
Prednisone 5 mg Orally twice daily, continuously
carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle
RAD 001: 5 mg orally starting on Day 2 then continuous
prednisone: 5 mg orally twice a day starting on Day 1 then continuous
laboratory biomarker analysis: Samples will be collected from archival tissue.
pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
622538|NCT01051570|P1|Participant Flow|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle
RAD 001: 5 mg Orally daily, starting from Day 2 continuously
Prednisone 5 mg Orally twice daily, continuously
carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle
RAD 001: 5 mg orally starting on Day 2 then continuous
prednisone: 5 mg orally twice a day starting on Day 1 then continuous
laboratory biomarker analysis: Samples will be collected from archival tissue.
pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
622646|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622539|NCT01051570|O1|Outcome|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle
RAD 001: 5 mg Orally daily, starting from Day 2 continuously
Prednisone 5 mg Orally twice daily, continuously
carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle
RAD 001: 5 mg orally starting on Day 2 then continuous
prednisone: 5 mg orally twice a day starting on Day 1 then continuous
laboratory biomarker analysis: Samples will be collected from archival tissue.
pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
622540|NCT01051570|E1|Reported Event|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle
RAD 001: 5 mg Orally daily, starting from Day 2 continuously
Prednisone 5 mg Orally twice daily, continuously
carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle
RAD 001: 5 mg orally starting on Day 2 then continuous
prednisone: 5 mg orally twice a day starting on Day 1 then continuous
laboratory biomarker analysis: Samples will be collected from archival tissue.
pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
622541|NCT01051739|B3|Baseline|Total|Total of all reporting groups
622542|NCT01051739|B2|Baseline|Group 2|normal - healthy observers with no eye pathology other than refractive error less than 6 diopters of correction.
622543|NCT01051739|B1|Baseline|Group 1|glaucoma with mean deviation from 0 to -25 dB
622544|NCT01051739|P2|Participant Flow|Group 2|normal ocular healthy controls
622545|NCT01051739|P1|Participant Flow|Group 1|glaucoma patients
622546|NCT01051739|O2|Outcome|Control|Age-matched healthy observers were tested at baseline and then every six months for 4 years
622547|NCT01051739|O1|Outcome|Glaucoma|mean deviation 0 to -25 dB
622548|NCT01051739|E2|Reported Event|Group 2|"normal
Comparison of four visual field testing strategies: We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm."
622549|NCT01051739|E1|Reported Event|Group 1|"glaucoma
Comparison of four visual field testing strategies: We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm."
622550|NCT01051778|B3|Baseline|Total|Total of all reporting groups
622551|NCT01051778|B2|Baseline|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
622552|NCT01051778|B1|Baseline|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
622553|NCT01051778|P2|Participant Flow|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
622554|NCT01051778|P1|Participant Flow|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
622555|NCT01051778|O2|Outcome|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
622556|NCT01051778|O1|Outcome|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
622557|NCT01051778|E2|Reported Event|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
622558|NCT01051778|E1|Reported Event|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
622559|NCT01051817|B3|Baseline|Total|Total of all reporting groups
622560|NCT01051817|B2|Baseline|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
622573|NCT01051856|B2|Baseline|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
622574|NCT01051856|B1|Baseline|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
622575|NCT01051856|P2|Participant Flow|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
622576|NCT01051856|P1|Participant Flow|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
622577|NCT01051856|O2|Outcome|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
622578|NCT01051856|O1|Outcome|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
622579|NCT01051856|O2|Outcome|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
622580|NCT01051856|O1|Outcome|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
622581|NCT01051856|E2|Reported Event|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
622582|NCT01051856|E1|Reported Event|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
622583|NCT01051921|B1|Baseline|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
622584|NCT01051921|P1|Participant Flow|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
622585|NCT01051921|O1|Outcome|CTS-1027, Pegylated Interferon, Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Pegylated Interferon, individual syringes delivering 180 µg of drug in 0.5 ml of solution administered once weekly.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
622647|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622586|NCT01051921|O1|Outcome|CTS-1027, Pegylated Interferon, Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.
Pegylated Interferon, individual syringes delivering 180 µg of drug in 0.5 ml of solution administered once weekly.
Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
622587|NCT01051921|E1|Reported Event|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
622588|NCT01051986|B3|Baseline|Total|Total of all reporting groups
622589|NCT01051986|B2|Baseline|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery
use saphenous vein as a composite graft connected to the left internal thoracic artery
saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
622590|NCT01051986|B1|Baseline|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery
use right internal thoracic artery as a composite graft connected to the left internal thoracic artery
right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
622591|NCT01051986|P2|Participant Flow|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery
use saphenous vein as a composite graft connected to the left internal thoracic artery
saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
622592|NCT01051986|P1|Participant Flow|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery
use right internal thoracic artery as a composite graft connected to the left internal thoracic artery
right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
622593|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery
use saphenous vein as a composite graft connected to the left internal thoracic artery
saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
622594|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery
use right internal thoracic artery as a composite graft connected to the left internal thoracic artery
right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
622595|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery
use saphenous vein as a composite graft connected to the left internal thoracic artery
saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
622732|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
622733|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
622596|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery
use right internal thoracic artery as a composite graft connected to the left internal thoracic artery
right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
622597|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery
use saphenous vein as a composite graft connected to the left internal thoracic artery
saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
622598|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery
use right internal thoracic artery as a composite graft connected to the left internal thoracic artery
right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
622599|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery
use saphenous vein as a composite graft connected to the left internal thoracic artery
saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
622600|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery
use right internal thoracic artery as a composite graft connected to the left internal thoracic artery
right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
622601|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery
use saphenous vein as a composite graft connected to the left internal thoracic artery
saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
622602|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery
use right internal thoracic artery as a composite graft connected to the left internal thoracic artery
right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
622603|NCT01051986|E2|Reported Event|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery
use saphenous vein as a composite graft connected to the left internal thoracic artery
saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
622648|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
623415|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
622604|NCT01051986|E1|Reported Event|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery
use right internal thoracic artery as a composite graft connected to the left internal thoracic artery
right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
622605|NCT01052038|B4|Baseline|Total|Total of all reporting groups
622606|NCT01052038|B3|Baseline|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
622607|NCT01052038|B2|Baseline|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
622608|NCT01052038|B1|Baseline|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
622609|NCT01052038|P3|Participant Flow|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
622610|NCT01052038|P2|Participant Flow|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
622611|NCT01052038|P1|Participant Flow|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
622612|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
622613|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
622614|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
622615|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
622616|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
622617|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
622618|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
622619|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
622620|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
622621|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
622622|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
622623|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
622624|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
622625|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
622626|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
622627|NCT01052038|E3|Reported Event|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
622632|NCT01052077|B1|Baseline|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622633|NCT01052077|P4|Participant Flow|Phase A+|Participants who met the criteria for a response at the end of the 8 weeks prospective treatment phase received single-blind placebo + ADT for an additional 6 weeks in Phase A+ for a total of 14 weeks.
622634|NCT01052077|P3|Participant Flow|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622635|NCT01052077|P2|Participant Flow|Brexiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622636|NCT01052077|P1|Participant Flow|Phase A|Participants entered a single-blind prospective treatment phase during which they received single-blind placebo plus open-label commercially available ADT for 8 weeks at maximally tolerated doses.
622637|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622638|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622639|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622640|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622641|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622642|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622643|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622644|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622923|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
622649|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622650|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622651|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622652|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622653|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622654|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622655|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622656|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622657|NCT01052077|E2|Reported Event|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
622658|NCT01052077|E1|Reported Event|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
622659|NCT01052116|B3|Baseline|Total|Total of all reporting groups
622660|NCT01052116|B2|Baseline|Soy Isoflavone|"Oral soy isoflavone supplement
Tablet twice a day (100 mg/day)"
622661|NCT01052116|B1|Baseline|Placebo|"Matching placebo
Tablet twice a day"
622662|NCT01052116|P2|Participant Flow|Soy Isoflavone|"Oral soy isoflavone supplement
Tablet twice a day (100 mg/day)"
622663|NCT01052116|P1|Participant Flow|Placebo|Matching placebo
622664|NCT01052116|O2|Outcome|Placebo|"Matching placebo
Tablet twice daily"
622665|NCT01052116|O1|Outcome|Soy Isoflavone|"Oral soy isoflavone supplement
tablet twice daily (100 mg/day)"
622666|NCT01052116|E2|Reported Event|Soy Isoflavone|"Oral soy isoflavone supplement
Tablet twice a day (100 mg/day)"
622667|NCT01052116|E1|Reported Event|Placebo|"Matching placebo
Tablet twice a day"
622669|NCT01052207|B2|Baseline|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
622670|NCT01052207|B1|Baseline|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.
Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
622671|NCT01052207|P2|Participant Flow|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
622672|NCT01052207|P1|Participant Flow|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.
Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
622673|NCT01052207|O2|Outcome|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
622674|NCT01052207|O1|Outcome|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.
Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
622675|NCT01052207|E2|Reported Event|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
622693|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
622676|NCT01052207|E1|Reported Event|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.
Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected. only if deemed part of their clinical care"
622677|NCT01052272|B5|Baseline|Total|Total of all reporting groups
622678|NCT01052272|B4|Baseline|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
622679|NCT01052272|B3|Baseline|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
622680|NCT01052272|B2|Baseline|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
622681|NCT01052272|B1|Baseline|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
622682|NCT01052272|P4|Participant Flow|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
622683|NCT01052272|P3|Participant Flow|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
622734|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
622735|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
622684|NCT01052272|P2|Participant Flow|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
622685|NCT01052272|P1|Participant Flow|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
622686|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
622687|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
622688|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
622689|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
622690|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
622691|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
622692|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
622694|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
622695|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
622696|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
622697|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
622698|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
622699|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
622700|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
622701|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
622702|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
622703|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
622704|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
622705|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
622706|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
622707|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
622708|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
622709|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
622710|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
622775|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622924|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
622711|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
622712|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
622713|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
622714|NCT01052272|E4|Reported Event|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
622715|NCT01052272|E3|Reported Event|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
622716|NCT01052272|E2|Reported Event|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
622717|NCT01052272|E1|Reported Event|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
622718|NCT01052428|B3|Baseline|Total|Total of all reporting groups
622719|NCT01052428|B2|Baseline|Toprol-XL|
622720|NCT01052428|B1|Baseline|Placebo|
622721|NCT01052428|P2|Participant Flow|Toprol-XL|
622722|NCT01052428|P1|Participant Flow|Placebo|
622723|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
622724|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
622725|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
622738|NCT01052428|E1|Reported Event|Placebo|
622758|NCT01042236|B1|Baseline|Entire Study Population|Includes groups randomized to receive Fesoterodine (4mg) first, Fesoterodine (8mg) first, and Placebo first.
622759|NCT01042236|P6|Participant Flow|Sequence CBA|Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
622760|NCT01042236|P5|Participant Flow|Sequence BAC|Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then placebo matching study treatment (C) with 7 day washout between dosing periods.
622761|NCT01042236|P4|Participant Flow|Sequence ACB|Fesoterodine 4 mg (A) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
622762|NCT01042236|P3|Participant Flow|Sequence CAB|Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
622763|NCT01042236|P2|Participant Flow|Sequence BCA|Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
622764|NCT01042236|P1|Participant Flow|Sequence ABC|Fesoterodine 4 mg (A) tablet administered by mouth (PO) once daily (OD) for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then placebo matching study treatment (C) with 7 day washout between dosing periods.
622765|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622766|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622767|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
622768|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622769|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622770|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
622771|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622772|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622773|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
622774|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
623416|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
622777|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622778|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622779|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
622780|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622781|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622782|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
622783|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622784|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622785|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
622786|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622787|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622788|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
622789|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622790|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622791|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
622792|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622793|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
627979|NCT01059760|O1|Outcome|Baseline Value|
622794|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
622795|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622796|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622797|NCT01042236|E3|Reported Event|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
622798|NCT01042236|E2|Reported Event|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622799|NCT01042236|E1|Reported Event|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
622800|NCT01042288|B1|Baseline|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy
Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
622801|NCT01042288|P1|Participant Flow|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy
Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
622802|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy
Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
622803|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy
Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
622804|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy
Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
622805|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy
Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
622806|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy
Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
622925|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
622926|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
623417|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
622807|NCT01042288|E1|Reported Event|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy
Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
622808|NCT01042366|B4|Baseline|Total|Total of all reporting groups
622809|NCT01042366|B3|Baseline|DCs Fused With Tumor Cells|"DCs fused with tumor cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
622810|NCT01042366|B2|Baseline|DCs Pulsed With Tumor Cell Lysates|"DCs pulsed with tumor cell lysates
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
622811|NCT01042366|B1|Baseline|DCs Co-cultured With Melanoma Cells|"DCs co-cultured with melanoma cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
622812|NCT01042366|P3|Participant Flow|DCs Fused With Tumor Cells|"DCs fused with tumor cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
622813|NCT01042366|P2|Participant Flow|DCs Pulsed With Tumor Cell Lysates|"DCs pulsed with tumor cell lysates
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
622814|NCT01042366|P1|Participant Flow|DCs Co-cultured With Melanoma Cells|"DCs co-cultured with melanoma cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
627980|NCT01059760|O3|Outcome|Change When Fed|
622815|NCT01042366|O3|Outcome|DCs Fused With Tumor Cells|"DCs fused with tumor cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
622816|NCT01042366|O2|Outcome|DCs Pulsed With Tumor Cell Lysates|"DCs pulsed with tumor cell lysates
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
622817|NCT01042366|O1|Outcome|DCs Co-cultured With Melanoma Cells|"DCs co-cultured with melanoma cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
622818|NCT01042366|O3|Outcome|DCs Fused With Tumor Cells|"DCs fused with tumor cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
622819|NCT01042366|O2|Outcome|DCs Pulsed With Tumor Cell Lysates|"DCs pulsed with tumor cell lysates
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
622820|NCT01042366|O1|Outcome|DCs Co-cultured With Melanoma Cells|"DCs co-cultured with melanoma cells
Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
622821|NCT01042366|E1|Reported Event|All Participants (Overall Study)|For all arms: DC vaccine Co-cultured With Melanoma Cells; DC Vaccine Pulsed With Tumor Cell Lysates; DC Vaccines Fused With Tumor Cells
622822|NCT01042392|B3|Baseline|Total|Total of all reporting groups
622927|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
622928|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
622929|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
622823|NCT01042392|B2|Baseline|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622824|NCT01042392|B1|Baseline|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622825|NCT01042392|P4|Participant Flow|Placebo to Aliskiren|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
622826|NCT01042392|P3|Participant Flow|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622827|NCT01042392|P2|Participant Flow|Placebo to Ramipril|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
622828|NCT01042392|P1|Participant Flow|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622829|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622830|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622897|NCT01042613|B2|Baseline|Standard|(standard technique of insertion of the intravenous cannula)
622831|NCT01042392|O4|Outcome|Placebo to Aliskiren|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
622832|NCT01042392|O3|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622833|NCT01042392|O2|Outcome|Placebo to Ramipril|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
622834|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622835|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622836|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622837|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622930|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
622838|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622839|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622840|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622841|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622842|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622843|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622844|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622898|NCT01042613|B1|Baseline|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
622845|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622846|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622847|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622848|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622849|NCT01042392|E4|Reported Event|Placebo to Aliskiren (Period III)|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
622850|NCT01042392|E3|Reported Event|Aliskiren (Period II and III)|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622851|NCT01042392|E2|Reported Event|Placebo to Ramipril (Period III)|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
622852|NCT01042392|E1|Reported Event|Ramipril (Period II and III)|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
622853|NCT01042496|B3|Baseline|Total|Total of all reporting groups
622854|NCT01042496|B2|Baseline|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622855|NCT01042496|B1|Baseline|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.
Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622856|NCT01042496|P2|Participant Flow|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622857|NCT01042496|P1|Participant Flow|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.
Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622858|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC).
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
622859|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.
Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622860|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC).
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
622899|NCT01042613|P2|Participant Flow|Standard|(standard technique of insertion of the intravenous cannula)
622861|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.
Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622862|NCT01042496|O4|Outcome|Bipolar Lamotrigine Group as Whole|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC) before and after treatment with Lamotrigine.
Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks.
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
622863|NCT01042496|O3|Outcome|Bipolar Lamotrigine Non-Responders Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.
Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).
Non-responders were those bipolar participants who did not achieve remission (defined as a Montgomery Asberg Depression Rating Scale (MADRS) score <12 at week 12)."
622864|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622865|NCT01042496|O1|Outcome|Bipolar Lamotrigine Responders Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.
Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks.
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622866|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622931|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
623418|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
622867|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.
Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622868|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622869|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.
Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622870|NCT01042496|E2|Reported Event|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622871|NCT01042496|E1|Reported Event|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.
Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks
1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
622872|NCT01042509|B1|Baseline|Patients With Chronic GVHD|Patients with chronic GVHD after first-line therapy failure.
622873|NCT01042509|P1|Participant Flow|Patients With Chronic GVHD|Patients with chronic GVHD after first-line therapy failure.
622874|NCT01042509|O1|Outcome|Treatment Group|This study had only one arm
622875|NCT01042509|O1|Outcome|Treatment Group|This study had only one arm
622876|NCT01042509|E1|Reported Event|Treatment Group|This study had only one arm
622877|NCT01042535|B1|Baseline|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)
1-methyl-d-tryptophan: Given orally (PO)
Laboratory biomarker analysis: Correlative studies"
622900|NCT01042613|P1|Participant Flow|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
622901|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
622902|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
622903|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
622878|NCT01042535|P1|Participant Flow|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)
1-methyl-d-tryptophan: Given orally (PO)
Laboratory biomarker analysis: Correlative studies"
622879|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)
1-methyl-d-tryptophan: Given orally (PO)
Laboratory biomarker analysis: Correlative studies"
622880|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)
1-methyl-d-tryptophan: Given orally (PO)
Laboratory biomarker analysis: Correlative studies"
622881|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)
1-methyl-d-tryptophan: Given orally (PO)
Laboratory biomarker analysis: Correlative studies"
622932|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
622933|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
622934|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
622935|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
622936|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
622882|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)
1-methyl-d-tryptophan: Given orally (PO)
Laboratory biomarker analysis: Correlative studies"
622883|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)
1-methyl-d-tryptophan: Given orally (PO)
Laboratory biomarker analysis: Correlative studies"
622884|NCT01042535|E1|Reported Event|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)
1-methyl-d-tryptophan: Given orally (PO)
Laboratory biomarker analysis: Correlative studies"
622885|NCT01042600|B3|Baseline|Total|Total of all reporting groups
622886|NCT01042600|B2|Baseline|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication
Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
622887|NCT01042600|B1|Baseline|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication
Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
622888|NCT01042600|P2|Participant Flow|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication
Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
622889|NCT01042600|P1|Participant Flow|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication
Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
622890|NCT01042600|O2|Outcome|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication
Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
622891|NCT01042600|O1|Outcome|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication
Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
622892|NCT01042600|O2|Outcome|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication
Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
622893|NCT01042600|O1|Outcome|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication
Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
622894|NCT01042600|E2|Reported Event|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication
Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
622895|NCT01042600|E1|Reported Event|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication
Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
622904|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
622905|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
622906|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
622907|NCT01042613|E2|Reported Event|Standard|(standard technique of insertion of the intravenous cannula)
622908|NCT01042613|E1|Reported Event|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
622909|NCT01042678|B4|Baseline|Total|Total of all reporting groups
622910|NCT01042678|B3|Baseline|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
622911|NCT01042678|B2|Baseline|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
622912|NCT01042678|B1|Baseline|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
622913|NCT01042678|P6|Participant Flow|MP0112 (3.6 mg)|Single 3.6 mg intravitreal injection of MP0112 in the study eye.
622914|NCT01042678|P5|Participant Flow|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
622915|NCT01042678|P4|Participant Flow|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
622916|NCT01042678|P3|Participant Flow|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
622917|NCT01042678|P2|Participant Flow|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
622918|NCT01042678|P1|Participant Flow|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
622919|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
622920|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
622921|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
622922|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
623419|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
622937|NCT01042678|E3|Reported Event|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
622938|NCT01042678|E2|Reported Event|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
622939|NCT01042678|E1|Reported Event|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
622940|NCT01042795|B1|Baseline|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
622941|NCT01042795|P1|Participant Flow|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
622942|NCT01042795|O1|Outcome|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
622943|NCT01042795|E1|Reported Event|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
622944|NCT01042938|B3|Baseline|Total|Total of all reporting groups
622945|NCT01042938|B2|Baseline|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
622946|NCT01042938|B1|Baseline|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
622947|NCT01042938|P2|Participant Flow|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
622948|NCT01042938|P1|Participant Flow|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
622949|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
622950|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
622951|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
622952|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
622953|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
622954|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
623004|NCT01043146|B5|Baseline|160 mg COR-1|single intravenous administration
622955|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(~4-7 weeks).
622956|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (~4-7 weeks).
622957|NCT01042938|E2|Reported Event|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
622958|NCT01042938|E1|Reported Event|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
622959|NCT01042977|B3|Baseline|Total|Total of all reporting groups
622960|NCT01042977|B2|Baseline|Placebo|Placebo plus usual care
622961|NCT01042977|B1|Baseline|Dapagliflozin|Dapagliflozin 10 mg plus usual care
622962|NCT01042977|P2|Participant Flow|Placebo|Placebo plus usual care
622963|NCT01042977|P1|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg plus usual care
622964|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
622965|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
622966|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
622967|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
622968|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
622969|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
622970|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
622971|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
622972|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
622973|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
622974|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
622975|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
622976|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
622977|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
622978|NCT01042977|E2|Reported Event|Placebo|Placebo plus usual care
622979|NCT01042977|E1|Reported Event|Dapagliflozin|Dapagliflozin 10 mg plus usual care
622980|NCT01043094|B3|Baseline|Total|Total of all reporting groups
622981|NCT01043094|B2|Baseline|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
622982|NCT01043094|B1|Baseline|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
622983|NCT01043094|P2|Participant Flow|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
622984|NCT01043094|P1|Participant Flow|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
622985|NCT01043094|O2|Outcome|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
622986|NCT01043094|O1|Outcome|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
622987|NCT01043094|O2|Outcome|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
622988|NCT01043094|O1|Outcome|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
622989|NCT01043094|E2|Reported Event|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
622990|NCT01043094|E1|Reported Event|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
622991|NCT01043133|B3|Baseline|Total|Total of all reporting groups
622992|NCT01043133|B2|Baseline|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
622993|NCT01043133|B1|Baseline|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
622994|NCT01043133|P2|Participant Flow|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
622995|NCT01043133|P1|Participant Flow|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
622996|NCT01043133|O2|Outcome|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
622997|NCT01043133|O1|Outcome|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
622998|NCT01043133|O2|Outcome|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
622999|NCT01043133|O1|Outcome|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
623000|NCT01043133|E2|Reported Event|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
623001|NCT01043133|E1|Reported Event|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
623002|NCT01043146|B7|Baseline|Total|Total of all reporting groups
623003|NCT01043146|B6|Baseline|240 mg COR-1|single intravenous administration
623005|NCT01043146|B4|Baseline|80 mg COR-1|single intravenous administration
623006|NCT01043146|B3|Baseline|40 mg COR-1|single intravenous administration
623007|NCT01043146|B2|Baseline|10 mg COR-1|single intravenous administration
623008|NCT01043146|B1|Baseline|Placebo|intravenous 0.9 % NaCl
623009|NCT01043146|P6|Participant Flow|240 mg COR-1|single intravenous administration
623010|NCT01043146|P5|Participant Flow|160 mg COR-1|single intravenous administration
623011|NCT01043146|P4|Participant Flow|80 mg COR-1|single intravenous administration
623012|NCT01043146|P3|Participant Flow|40 mg COR-1|single intravenous administration
623013|NCT01043146|P2|Participant Flow|10 mg COR-1|single intravenous administration
623014|NCT01043146|P1|Participant Flow|Placebo|intravenous 0.9 % NaCl
623015|NCT01043146|O6|Outcome|240 mg COR-1|single intravenous administration
623016|NCT01043146|O5|Outcome|160 mg COR-1|single intravenous administration
623017|NCT01043146|O4|Outcome|80 mg COR-1|single intravenous administration
623018|NCT01043146|O3|Outcome|40 mg COR-1|single intravenous administration
623019|NCT01043146|O2|Outcome|10 mg COR-1|single intravenous administration
623020|NCT01043146|O1|Outcome|Placebo|intravenous 0.9 % NaCl
623021|NCT01043146|E6|Reported Event|240 mg COR-1|single intravenous administration
623022|NCT01043146|E5|Reported Event|160 mg COR-1|single intravenous administration
623023|NCT01043146|E4|Reported Event|80 mg COR-1|single intravenous administration
623024|NCT01043146|E3|Reported Event|40 mg COR-1|single intravenous administration
623025|NCT01043146|E2|Reported Event|10 mg COR-1|single intravenous administration
623026|NCT01043146|E1|Reported Event|Placebo|intravenous 0.9 % NaCl
623027|NCT01043185|B1|Baseline|Entire Study Population|Includes all groups randomized to one of 10 sequences of drug or placebo.
623028|NCT01043185|P10|Participant Flow|First Placebo, Then 120mg, Then 30mg, Then 240mg|Period 1: placebo. Period 2: AZD3355 120mg. Period 3: AZD3355 30mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
623029|NCT01043185|P9|Participant Flow|First 240mg, Then 30mg, Then 90mg, Then Placebo|Period 1: AZD3355 240mg. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: placebo. Morning and evening dose in each period.
623030|NCT01043185|P8|Participant Flow|First 120mg, Then 30mg, Then 240mg, Then Placebo|Period 1: AZD3355 120mg. Period 2: AZD3355 30mg. Period 3: AZD3355 240mg. Period 4: placebo. Morning and evening dose in each period.
623031|NCT01043185|P7|Participant Flow|First 90mg, Then 120mg, Then Placebo, Then 240mg|Period 1: AZD3355 90mg. Period 2: AZD3355 120mg. Period 3: placebo. Period 4: AZD3355 240mg. Morning and evening dose in each period.
623032|NCT01043185|P6|Participant Flow|First Placebo, Then 240mg, Then 90mg, Then 30mg|Period 1: placebo. Period 2: AZD3355 240mg. Period 3: AZD3355 90mg. Period 4: AZD3355 30mg. Morning and evening dose in each period.
623033|NCT01043185|P5|Participant Flow|First 90mg, Then Placebo, Then 120mg, Then 240mg|Period 1: AZD3355 90mg. Period 2: placebo. Period 3: AZD3355 120mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
623034|NCT01043185|P4|Participant Flow|First Placebo, Then 30mg, Then 90mg, Then 120mg|Period 1: placebo. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: AZD3355 120mg. Morning and evening dose in each period.
623035|NCT01043185|P3|Participant Flow|First 120mg, Then Placebo, Then 240mg, Then 90mg|Period 1: AZD3355 120mg. Period 2: placebo. Period 3: AZD3355 240mg. Period 4: AZD3355 90mg. Morning and evening dose in each period.
623217|NCT01053312|O4|Outcome|Subject 201-0004|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
623036|NCT01043185|P2|Participant Flow|First 30mg, Then 90mg, Then Placebo, Then 120mg|Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: placebo. Period 4: AZD3355 120mg. Morning and evening dose in each period.
623037|NCT01043185|P1|Participant Flow|First 30mg, Then 90mg, Then 120mg, Then Placebo|Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: AZD3355 120mg. Period 4: placebo. Morning and evening dose in each period.
623038|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
623039|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
623040|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
623041|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
623042|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
623043|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
623044|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
623045|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
623046|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
623047|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
623048|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
623049|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
623050|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
623051|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
623052|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
623053|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
623054|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
623055|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
623056|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
623057|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
623058|NCT01043185|E5|Reported Event|Placebo|a morning and an evening dose of placebo
623059|NCT01043185|E4|Reported Event|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
623060|NCT01043185|E3|Reported Event|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
623061|NCT01043185|E2|Reported Event|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
623062|NCT01043185|E1|Reported Event|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
623064|NCT01052480|B2|Baseline|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623065|NCT01052480|B1|Baseline|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623066|NCT01052480|P2|Participant Flow|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623067|NCT01052480|P1|Participant Flow|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623068|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623069|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623070|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623071|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623072|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623073|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623074|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623075|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623076|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623077|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623078|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623179|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623079|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623080|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623081|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623082|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623083|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623084|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623085|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623086|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623087|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623088|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623089|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623090|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623162|NCT01053156|P2|Participant Flow|Placebo First, Minocycline Second|Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months
623318|NCT01053897|O3|Outcome|No Difference|No scar segment was preferred to the other
623091|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623092|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623093|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623094|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623095|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623096|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623097|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623098|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623099|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623100|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623101|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623102|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623103|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623104|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623215|NCT01053312|O6|Outcome|Subject 201-0006|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
623420|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623105|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623106|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623107|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623108|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623109|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623110|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623111|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623112|NCT01052480|E2|Reported Event|Standard Care|"Participants will receive standard care.
Standard Care: Standard care for hospitalized people with influenza"
623113|NCT01052480|E1|Reported Event|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard Care: Standard care for hospitalized people with influenza"
623114|NCT01052545|B3|Baseline|Total|Total of all reporting groups
623115|NCT01052545|B2|Baseline|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
623156|NCT01052701|O1|Outcome|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention
Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
or
Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)
plus
Daily Abacavir 300 mg orally every 12 hours"
623157|NCT01052701|E2|Reported Event|Ribavirin Alone|"Ribavirin alone administration
Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
OR
Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
623116|NCT01052545|B1|Baseline|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
623117|NCT01052545|P2|Participant Flow|Arm 2- Control|This was the contemporary control group. Surveillance for the outcomes of interest (urine cultures order and antibiotics used to treat urine cultures) continued for all 3 years. Providers at this site received standard education about the CAUTI and asymptomatic bacteriuria guidelines delivered in a grand rounds format, and they also received a PDF of the full guidelines by email.
623118|NCT01052545|P1|Participant Flow|Arm 1- Intervention: Audit-Feedback|"Year 1: baseline surveillance at both sites Year 2: case based, individual audit and feedback delivered to providers, a guidelines based diagnostic algorithm for CAUTI versus asymptomatic bacteriuria (ASB) was given to providers and reinforced in the audit and feedback sessions.
Year 3: cased based, group audit and feedback delivered to providers, again based on this dignostic algorithm.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
623119|NCT01052545|O2|Outcome|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
623120|NCT01052545|O1|Outcome|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
623121|NCT01052545|O2|Outcome|Control Group|Cases of positive urine cultures on medicine and extended care wards at the control site
623122|NCT01052545|O1|Outcome|Intervention Group|Cases of positive urine cultures on medicine and extended care wards at the intervention site
623123|NCT01052545|O2|Outcome|Control Group|Medicine and extended care wards at control site
623124|NCT01052545|O1|Outcome|Intervention Group|Medicine and extended care wards at the intervention site
623216|NCT01053312|O5|Outcome|Subject 201-0005|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
623421|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623125|NCT01052545|O2|Outcome|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
623126|NCT01052545|O1|Outcome|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
623127|NCT01052545|E2|Reported Event|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
623128|NCT01052545|E1|Reported Event|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.
Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
623129|NCT01052662|B4|Baseline|Total|Total of all reporting groups
623130|NCT01052662|B3|Baseline|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks"
623158|NCT01052701|E1|Reported Event|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention
Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
or
Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)
plus
Daily Abacavir 300 mg orally every 12 hours"
623159|NCT01053156|B3|Baseline|Total|Total of all reporting groups
623160|NCT01053156|B2|Baseline|Placebo First, Minocycline Second|Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months
623131|NCT01052662|B2|Baseline|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
623132|NCT01052662|B1|Baseline|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks"
623133|NCT01052662|P3|Participant Flow|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks"
623134|NCT01052662|P2|Participant Flow|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
623145|NCT01052662|E3|Reported Event|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks"
623135|NCT01052662|P1|Participant Flow|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks"
623136|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks"
623137|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
623138|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks"
623139|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks"
623140|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
623161|NCT01053156|B1|Baseline|Minocycline First, Placebo Second|Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.
623141|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks"
623142|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks"
623143|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
623144|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks"
623146|NCT01052662|E2|Reported Event|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
623147|NCT01052662|E1|Reported Event|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks"
623148|NCT01052701|B3|Baseline|Total|Total of all reporting groups
623149|NCT01052701|B2|Baseline|Ribavirin Alone|"Ribavirin alone administration
Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
or
Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
623150|NCT01052701|B1|Baseline|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention
Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
or
Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)
plus
Daily Abacavir 300 mg orally every 12 hours"
623151|NCT01052701|P2|Participant Flow|Ribavirin Alone|"Ribavirin alone administration
Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
OR
Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
623152|NCT01052701|P1|Participant Flow|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention
Ribavirin plus Abacavir: Daily Ribavirin 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg)
or
Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)
plus
Daily Abacavir 300 mg orally every 12 hours"
623153|NCT01052701|O2|Outcome|Ribavirin Alone|"Ribavirin alone administration
Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
OR
Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
623154|NCT01052701|O1|Outcome|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention
Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
or
Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)
plus
Daily Abacavir 300 mg orally every 12 hours"
623155|NCT01052701|O2|Outcome|Ribavirin Alone|"Ribavirin alone administration
Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
OR
Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
623312|NCT01053897|B1|Baseline|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
623163|NCT01053156|P1|Participant Flow|Minocycline First, Then Placebo Second|Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.
623164|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623165|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623166|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
623167|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623168|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623169|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
623170|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623171|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623172|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
623173|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623174|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623175|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
623176|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623177|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623178|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
623422|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623180|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623181|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
623182|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623183|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623184|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
623185|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623186|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623187|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
623188|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623189|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623190|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
623191|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623192|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623193|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
623194|NCT01053156|O2|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623195|NCT01053156|O1|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623313|NCT01053897|P1|Participant Flow|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
623196|NCT01053156|E2|Reported Event|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623197|NCT01053156|E1|Reported Event|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
623198|NCT01053247|B4|Baseline|Total|Total of all reporting groups
623199|NCT01053247|B3|Baseline|Vehicle|"Placebo that contains no active pharmaceutical ingredient
Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
623200|NCT01053247|B2|Baseline|Reference|"Reference product that contains active pharmaceutical ingredient
Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
623201|NCT01053247|B1|Baseline|Test|"Test product that contains the active pharmaceutical ingredient
Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
623202|NCT01053247|P3|Participant Flow|Vehicle|"Placebo that contains no active pharmaceutical ingredient
Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
623203|NCT01053247|P2|Participant Flow|Reference|"Reference product that contains active pharmaceutical ingredient
Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
623204|NCT01053247|P1|Participant Flow|Test|"Test product that contains the active pharmaceutical ingredient
Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
623205|NCT01053247|O3|Outcome|Vehicle|"Placebo that contains no active pharmaceutical ingredient
Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
623206|NCT01053247|O2|Outcome|Reference|"Reference product that contains active pharmaceutical ingredient
Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
623207|NCT01053247|O1|Outcome|Test|"Test product that contains the active pharmaceutical ingredient
Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
623208|NCT01053247|E3|Reported Event|Vehicle|"Placebo that contains no active pharmaceutical ingredient
Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
623209|NCT01053247|E2|Reported Event|Reference|"Reference product that contains active pharmaceutical ingredient
Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
623210|NCT01053247|E1|Reported Event|Test|"Test product that contains the active pharmaceutical ingredient
Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
623211|NCT01053312|B1|Baseline|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
623212|NCT01053312|P1|Participant Flow|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
623213|NCT01053312|O1|Outcome|Amyloid Level (Plaque Load)|Amlyoid level estimate from the Immunohistochemistry assay: Percent plaque area (average across slides) for mAb NAB228.
623214|NCT01053312|O7|Outcome|Subject 201-0007|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
623218|NCT01053312|O3|Outcome|Subject 201-0003|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
623219|NCT01053312|O2|Outcome|Subject 201-0002|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
623220|NCT01053312|O1|Outcome|Subject 201-0001|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
623221|NCT01053312|O7|Outcome|Subject 201-0007|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
623222|NCT01053312|O6|Outcome|Subject 201-0006|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
623223|NCT01053312|O5|Outcome|Subject 201-0005|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
623224|NCT01053312|O4|Outcome|Subject 201-0004|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
623225|NCT01053312|O3|Outcome|Subject 201-0003|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
623226|NCT01053312|O2|Outcome|Subject 201-0002|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
623227|NCT01053312|O1|Outcome|Subject 201-0001|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
623228|NCT01053312|E1|Reported Event|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
623229|NCT01053429|B1|Baseline|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
623230|NCT01053429|P1|Participant Flow|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
623231|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
623232|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
623233|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
623234|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
623235|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
623236|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
623237|NCT01053429|E1|Reported Event|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
623238|NCT01053507|B3|Baseline|Total|Total of all reporting groups
623239|NCT01053507|B2|Baseline|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.
Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623240|NCT01053507|B1|Baseline|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.
sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623241|NCT01053507|P2|Participant Flow|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.
Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623242|NCT01053507|P1|Participant Flow|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.
sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623243|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.
Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623244|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.
sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623245|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.
Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623246|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.
sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623247|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.
Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623248|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.
sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623343|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623249|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.
Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623250|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.
sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623251|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.
Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623252|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.
sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623253|NCT01053507|E2|Reported Event|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.
Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623254|NCT01053507|E1|Reported Event|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.
sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
623255|NCT01053663|B4|Baseline|Total|Total of all reporting groups
623256|NCT01053663|B3|Baseline|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623257|NCT01053663|B2|Baseline|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623314|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment
623258|NCT01053663|B1|Baseline|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623259|NCT01053663|P1|Participant Flow|Oseltamivir - All Participants|Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to less than (<) 365 days received 3 milligrams per kilogram (mg/kg); participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623260|NCT01053663|O4|Outcome|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623261|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623262|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623263|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623264|NCT01053663|O4|Outcome|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623344|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623265|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623266|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623267|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623268|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623269|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623270|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623271|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623272|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623273|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623274|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623275|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623276|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623277|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623278|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623279|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623280|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623423|NCT01054170|E2|Reported Event|Placebo|Placebo 2 tablets bid
623281|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623282|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623283|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623284|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623285|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623286|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623287|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623288|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623315|NCT01053897|O1|Outcome|GBT009|Therapy treated scar segment
623289|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623290|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623291|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623292|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623293|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623294|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623295|NCT01053663|E4|Reported Event|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623345|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623346|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623296|NCT01053663|E3|Reported Event|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623297|NCT01053663|E2|Reported Event|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623298|NCT01053663|E1|Reported Event|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
623299|NCT01053741|B3|Baseline|Total|Total of all reporting groups
623300|NCT01053741|B2|Baseline|Normosol-R Then Seminal Fluid|"2.5 mL radiolabeled Normosol-R administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled autologous seminal fluid administered rectally X1.
Radiolabeled autologous seminal fluid: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.
Radiolabeled Normosol-R: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle."
623301|NCT01053741|B1|Baseline|Seminal Fluid Then Normosol|"2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled Normosol-R administered rectally X1.
Radiolabeled autologous seminal fluid: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.
Radiolabeled Normosol-R: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle."
623302|NCT01053741|P2|Participant Flow|Normosol-R Then Seminal Fluid|Subjects first received 2.5 mL radiolabeled Normosol-R administered rectally x1. Then a two week pause between interventions. Followed by 2.5 mL radiolabeled autologous seminal fluid administered rectally x1.
623303|NCT01053741|P1|Participant Flow|Seminal Fluid, Then Normosol-R|Subjects first received 2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Than a two week pause between interventions. Followed by 2.5 mL radiolabeled Normosol-R administered rectally x1.
623304|NCT01053741|O2|Outcome|Normosol-R|Normosol-R Intervention
623305|NCT01053741|O1|Outcome|Seminal Fluid|Seminal Fluid Intervention
623306|NCT01053741|E2|Reported Event|Normosol-R|Normosol-R Intervention
623307|NCT01053741|E1|Reported Event|Seminal Fluid|Seminal Fluid Intervention
623308|NCT01053819|B1|Baseline|Etanercept|open label treatment per FDA approval for 24 weeks
623309|NCT01053819|P1|Participant Flow|Etanercept|Patients will receive six months of treatment with Enbrel 50mg SC given twice a week for the first three months and 50 mg once a week thereafter.
623310|NCT01053819|O1|Outcome|Etanercept|open label treatment per FDA approval for 24 weeks
623311|NCT01053819|E1|Reported Event|Etanercept|open label treatment per FDA approval for 24 weeks
623316|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment
623319|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment preferred
623320|NCT01053897|O1|Outcome|GBT009|GBT009 treated scar segment preferred
623321|NCT01053897|O2|Outcome|Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
623322|NCT01053897|O1|Outcome|GBT009|All subjects acted as their own control receiving both GBT009 and Placebo
623323|NCT01053897|E1|Reported Event|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
623324|NCT01053988|B6|Baseline|Total|Total of all reporting groups
623325|NCT01053988|B5|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623326|NCT01053988|B4|Baseline|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
623327|NCT01053988|B3|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623328|NCT01053988|B2|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623329|NCT01053988|B1|Baseline|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623330|NCT01053988|P6|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623331|NCT01053988|P5|Participant Flow|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
623332|NCT01053988|P4|Participant Flow|VI 25 µg OD|Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks.
623333|NCT01053988|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.
623334|NCT01053988|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.
623335|NCT01053988|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks.
623336|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623337|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
623338|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623339|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623340|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623341|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623342|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
623347|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
623348|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623349|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623350|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623351|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623352|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
623353|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623354|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623355|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623356|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623357|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
623358|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623359|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623360|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623361|NCT01053988|E5|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623362|NCT01053988|E4|Reported Event|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
623363|NCT01053988|E3|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623364|NCT01053988|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623365|NCT01053988|E1|Reported Event|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623366|NCT01054079|B1|Baseline|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: Correlative study
quality-of-life assessment: Ancillary study
questionnaire administration: Ancillary study
cinacalcet hydrochloride: Given PO"
623367|NCT01054079|P1|Participant Flow|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: Correlative study
quality-of-life assessment: Ancillary study
questionnaire administration: Ancillary study
cinacalcet hydrochloride: Given PO"
623470|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
623368|NCT01054079|O1|Outcome|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: Correlative study
quality-of-life assessment: Ancillary study
questionnaire administration: Ancillary study
cinacalcet hydrochloride: Given PO"
623369|NCT01054079|E1|Reported Event|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis: Correlative study
quality-of-life assessment: Ancillary study
questionnaire administration: Ancillary study
cinacalcet hydrochloride: Given PO"
623370|NCT01054170|B3|Baseline|Total|Total of all reporting groups
623371|NCT01054170|B2|Baseline|Placebo|Placebo 2 tablets bid
623372|NCT01054170|B1|Baseline|AZD9668|AZD9668 2x30mg bid
623373|NCT01054170|P2|Participant Flow|Placebo|Placebo 2 tablets bid
623374|NCT01054170|P1|Participant Flow|AZD9668|AZD9668 2x30mg bid
623375|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623376|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623377|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623378|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623379|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623380|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623381|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623382|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623383|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623384|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623385|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623386|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623387|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623388|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623389|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623390|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623391|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623392|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623393|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623394|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623395|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623396|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623397|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623398|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623399|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623400|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623401|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623402|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623403|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623404|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623405|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623406|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623407|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
623408|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
623424|NCT01054170|E1|Reported Event|AZD9668|AZD9668 2x30mg bid
623425|NCT01054183|B3|Baseline|Total|Total of all reporting groups
623426|NCT01054183|B2|Baseline|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.
Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
623427|NCT01054183|B1|Baseline|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.
GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
623428|NCT01054183|P2|Participant Flow|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.
Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
623429|NCT01054183|P1|Participant Flow|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.
GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
623430|NCT01054183|O2|Outcome|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.
Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
623431|NCT01054183|O1|Outcome|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.
GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
623469|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
623432|NCT01054183|O2|Outcome|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.
Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
623433|NCT01054183|O1|Outcome|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.
GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
623434|NCT01054183|E2|Reported Event|Direct Laryngoscopy|Procedure used to visualize the vocal cords and perform tracheal intubation in the pediatric and neonatal population.
623435|NCT01054183|E1|Reported Event|GlideScope Video Laryngoscope Ranger(GVL)|Procedure used to perform tracheal intubation that facilitates indirect visualization of the glottis through a video display.
623436|NCT01054222|B1|Baseline|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623437|NCT01054222|P1|Participant Flow|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623438|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623439|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623440|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623441|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623442|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623443|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623444|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623445|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623446|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623447|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623448|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623449|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623450|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623451|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623452|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623453|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623454|NCT01054222|E1|Reported Event|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
623455|NCT01054339|B4|Baseline|Total|Total of all reporting groups
623456|NCT01054339|B3|Baseline|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
624828|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
623457|NCT01054339|B2|Baseline|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
623458|NCT01054339|B1|Baseline|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
623459|NCT01054339|P3|Participant Flow|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
623460|NCT01054339|P2|Participant Flow|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
623461|NCT01054339|P1|Participant Flow|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
623462|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
623463|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
623464|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
623465|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
623466|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
623467|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
623468|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
623471|NCT01054339|E3|Reported Event|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
623472|NCT01054339|E2|Reported Event|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
623473|NCT01054339|E1|Reported Event|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
623474|NCT01054404|B3|Baseline|Total|Total of all reporting groups
623475|NCT01054404|B2|Baseline|Placebo|Placebo : Placebo (up to 5mL)
623476|NCT01054404|B1|Baseline|Furosemide|Furosemide : Furosemide 0.3 mg/kg
623477|NCT01054404|P2|Participant Flow|Placebo|Placebo : Placebo (up to 5mL)
623478|NCT01054404|P1|Participant Flow|Furosemide|Furosemide : Furosemide 0.3 mg/kg
623479|NCT01054404|O2|Outcome|Placebo|Placebo : Placebo (up to 5mL)
623480|NCT01054404|O1|Outcome|Furosemide|Furosemide : Furosemide 0.3 mg/kg
623481|NCT01054404|E2|Reported Event|Placebo|Placebo : Placebo (up to 5mL)
623482|NCT01054404|E1|Reported Event|Furosemide|Furosemide : Furosemide 0.3 mg/kg
623483|NCT01054560|B3|Baseline|Total|Total of all reporting groups
623484|NCT01054560|B2|Baseline|MERCI® Device|The MERCI® Device (control device) is commercially available.
623485|NCT01054560|B1|Baseline|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
623486|NCT01054560|P2|Participant Flow|MERCI® Device|The MERCI® Device (control device) is commercially available.
623487|NCT01054560|P1|Participant Flow|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
623488|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
623489|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
623490|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
623491|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
623492|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
623493|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
623494|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
623495|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
623496|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
623497|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
623498|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
623499|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
623500|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
623501|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
623502|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
623503|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
623504|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
623505|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
623506|NCT01054560|E2|Reported Event|The MERCI® Device|The MERCI® Device (control device) is commercially available.
623507|NCT01054560|E1|Reported Event|The SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
623508|NCT01054573|B5|Baseline|Total|Total of all reporting groups
623571|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
623572|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623509|NCT01054573|B4|Baseline|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
623510|NCT01054573|B3|Baseline|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
623511|NCT01054573|B2|Baseline|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
623512|NCT01054573|B1|Baseline|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
623513|NCT01054573|P4|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
623514|NCT01054573|P3|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
623596|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623597|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623515|NCT01054573|P2|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
623516|NCT01054573|P1|Participant Flow|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
623517|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 8, 7, and 7, respectively.
623518|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 26, 26, 26, 24, 23, and 21, respectively.
623519|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 22, 22, 22, 20, 19, and 16, respectively.
623520|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 32, 32, 31, 23, 18, and 15, respectively.
623521|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 9, 9, 8, 7, and 7, respectively.
623522|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 27, 26, 26, 26, 24, 23, and 21, respectively.
623523|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 22, 22, 22, 22, 20, 19, and 16, respectively.
623524|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 32, 32, 32, 31, 23, 18, and 16, respectively.
623573|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623525|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
623526|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
623527|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
623528|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
623529|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
623530|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
623531|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
623598|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623532|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
623533|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
623534|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
623535|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
623536|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
623537|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
623538|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
623539|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
623540|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
623541|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
623542|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
623543|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
623574|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
623544|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
623545|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
623546|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
623547|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
623548|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
623549|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
623550|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
623599|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
623676|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
623551|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
623552|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
623553|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
623554|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
623555|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
623556|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
623557|NCT01054573|E2|Reported Event|Phase 3: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons (ncludes all participants, ie, those categorized as prior null responders, prior partial responders, and prior relapsers).
623558|NCT01054573|E1|Reported Event|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
623559|NCT01054586|B5|Baseline|Total|Total of all reporting groups
623560|NCT01054586|B4|Baseline|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
623561|NCT01054586|B3|Baseline|FPV, Other|All other dosages of Fosamprenavir
623562|NCT01054586|B2|Baseline|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
623563|NCT01054586|B1|Baseline|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623564|NCT01054586|P4|Participant Flow|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
623565|NCT01054586|P3|Participant Flow|FPV, Other|All other dosages of FPV (excluding FPV 700 mg BID/RTV 100 mg BID and FPV 700 mg BID/RTV 100 mg QD)
623566|NCT01054586|P2|Participant Flow|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
623567|NCT01054586|P1|Participant Flow|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623568|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623569|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623570|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
623575|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
623576|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
623577|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
623578|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623579|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623580|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
623581|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623582|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623583|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623584|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
623585|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623586|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
623587|NCT01054586|O2|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623588|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623589|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623590|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623591|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
623592|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623593|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623594|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623595|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
623600|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623601|NCT01054586|O2|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623602|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623603|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623604|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623605|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
623606|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
623607|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623608|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623609|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
623610|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
623611|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623612|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623613|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
623614|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
623615|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623616|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623617|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
623618|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
623619|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623620|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623621|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
623622|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|
623623|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
623624|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623625|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
623626|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623627|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
623628|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623629|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
623630|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623631|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
623632|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623633|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
623634|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623635|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
623636|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
623637|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
623638|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623639|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
623640|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
623641|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623642|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
623643|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
623644|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623645|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
623646|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
623647|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623648|NCT01054586|O2|Outcome|Not ART naïve|Patients who have previously been exposed to ART therapy
623649|NCT01054586|O1|Outcome|ART naïve|Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
623650|NCT01054586|E4|Reported Event|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
623651|NCT01054586|E3|Reported Event|FPV, Other|All other dosages of Fosamprenavir
623652|NCT01054586|E2|Reported Event|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
623653|NCT01054586|E1|Reported Event|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
623654|NCT01054599|B3|Baseline|Total|Total of all reporting groups
623655|NCT01054599|B2|Baseline|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
623673|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
623674|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
623675|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
623656|NCT01054599|B1|Baseline|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
623657|NCT01054599|P2|Participant Flow|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
623658|NCT01054599|P1|Participant Flow|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
623659|NCT01054599|O2|Outcome|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
623660|NCT01054599|O1|Outcome|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
623661|NCT01054599|O2|Outcome|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
623713|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623714|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623715|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623716|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623662|NCT01054599|O1|Outcome|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
623663|NCT01054599|E2|Reported Event|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
623664|NCT01054599|E1|Reported Event|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
623665|NCT01054625|B4|Baseline|Total|Total of all reporting groups
623666|NCT01054625|B3|Baseline|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
623667|NCT01054625|B2|Baseline|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
623668|NCT01054625|B1|Baseline|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
623669|NCT01054625|P3|Participant Flow|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
623670|NCT01054625|P2|Participant Flow|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
623671|NCT01054625|P1|Participant Flow|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
623672|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
623677|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
623678|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
623679|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
623680|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
623681|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
623682|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
623683|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
623684|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
623685|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
623686|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
623687|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
623688|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
623689|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
623690|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
623691|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
623692|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
623693|NCT01054625|E3|Reported Event|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
623694|NCT01054625|E2|Reported Event|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
623695|NCT01054625|E1|Reported Event|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
623696|NCT01054703|B1|Baseline|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
623697|NCT01054703|P1|Participant Flow|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
623698|NCT01054703|O1|Outcome|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
623699|NCT01054703|E1|Reported Event|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
623700|NCT01054729|B5|Baseline|Total|Total of all reporting groups
623701|NCT01054729|B4|Baseline|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
623702|NCT01054729|B3|Baseline|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623703|NCT01054729|B2|Baseline|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623704|NCT01054729|B1|Baseline|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623705|NCT01054729|P4|Participant Flow|Placebo+PEG+RBV|Participants received placebo to match sofosbuvir for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
623706|NCT01054729|P3|Participant Flow|Sofosbuvir 400 mg+PEG+RBV|Participants received sofosbuvir 400 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
623707|NCT01054729|P2|Participant Flow|Sofosbuvir 200 mg+PEG+RBV|Participants received sofosbuvir 200 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
623708|NCT01054729|P1|Participant Flow|Sofosbuvir 100 mg+PEG+RBV|Participants received sofosbuvir 100 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
623709|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623710|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623711|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623712|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623717|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623718|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623719|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623720|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623721|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623722|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623723|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623724|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623725|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623726|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623727|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623728|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623729|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623730|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623731|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623732|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623733|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623734|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623735|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
627981|NCT01059760|O2|Outcome|Change While Fasting|
623736|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623737|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623738|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623739|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623740|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623741|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623742|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623743|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623744|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623745|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623746|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623747|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623748|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
623749|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623750|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623751|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623752|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
623753|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623754|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623755|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623756|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
623757|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623758|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623759|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623760|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
623761|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623762|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623763|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623764|NCT01054729|E4|Reported Event|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
623765|NCT01054729|E3|Reported Event|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
623766|NCT01054729|E2|Reported Event|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
623767|NCT01054729|E1|Reported Event|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
623768|NCT01054742|B1|Baseline|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
623769|NCT01054742|P1|Participant Flow|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
623834|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
623770|NCT01054742|O1|Outcome|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
623771|NCT01054742|E1|Reported Event|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
623772|NCT01054820|B1|Baseline|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623773|NCT01054820|P1|Participant Flow|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623774|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623775|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623776|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623802|NCT01054885|B1|Baseline|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
624244|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
623777|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623778|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623779|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623780|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623781|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623782|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623783|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623784|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623785|NCT01054820|E1|Reported Event|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
623786|NCT01054846|B3|Baseline|Total|Total of all reporting groups
623787|NCT01054846|B2|Baseline|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.
Bicycle helmet education only: As described under the respective arm"
623788|NCT01054846|B1|Baseline|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.
Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
623789|NCT01054846|P2|Participant Flow|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.
Bicycle helmet education only: As described under the respective arm"
623835|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623836|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623790|NCT01054846|P1|Participant Flow|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.
Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
623791|NCT01054846|O2|Outcome|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.
Bicycle helmet education only: As described under the respective arm"
623792|NCT01054846|O1|Outcome|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.
Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
623793|NCT01054846|O2|Outcome|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.
Bicycle helmet education only: As described under the respective arm"
623794|NCT01054846|O1|Outcome|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.
Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
623795|NCT01054846|E1|Reported Event|All Study Participants|
623796|NCT01054885|B7|Baseline|Total|Total of all reporting groups
623797|NCT01054885|B6|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
623798|NCT01054885|B5|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623799|NCT01054885|B4|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623800|NCT01054885|B3|Baseline|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
623801|NCT01054885|B2|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623803|NCT01054885|P7|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
623804|NCT01054885|P6|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623805|NCT01054885|P5|Participant Flow|VI 25 µg OD|Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks.
623806|NCT01054885|P4|Participant Flow|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
623807|NCT01054885|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.
623808|NCT01054885|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.
623809|NCT01054885|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks.
623810|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
623811|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623812|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623813|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
623814|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623815|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623816|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
623817|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623818|NCT01054885|O4|Outcome|FVI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623819|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
623820|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623821|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623822|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
623823|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623824|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623825|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
623826|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623827|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623828|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
623829|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623830|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623831|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
623832|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623833|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623837|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
623838|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623839|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623840|NCT01054885|E6|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
623841|NCT01054885|E5|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
623842|NCT01054885|E4|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
623843|NCT01054885|E3|Reported Event|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
623844|NCT01054885|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
623845|NCT01054885|E1|Reported Event|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
623846|NCT01054911|B1|Baseline|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
623877|NCT01055171|P1|Participant Flow|Propranolol|"Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
623878|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
623847|NCT01054911|P1|Participant Flow|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
623848|NCT01054911|O1|Outcome|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
623849|NCT01054911|O1|Outcome|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
623850|NCT01054911|O2|Outcome|Neoadjuvant Therapy no Surgery|Patients received oral therapy for up to 12 weeks. Reassessment demonstrated response, but no surgical intervention
623851|NCT01054911|O1|Outcome|Neoadjuvant Therapy Plus Surgery|Patients received oral therapy for up to 12 weeks and re-evaluated for response. Favorable tumor reduction resulted surgical extirpation typically with less morbid operative intervention.
623852|NCT01054911|E1|Reported Event|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
623853|NCT01054976|B1|Baseline|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
623854|NCT01054976|P1|Participant Flow|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
623855|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
623856|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
623857|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
623858|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
623859|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
623860|NCT01054976|E1|Reported Event|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
623861|NCT01055132|B1|Baseline|All Subjects|All subjects who completed the study.
623862|NCT01055132|P2|Participant Flow|Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second|Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days
623863|NCT01055132|P1|Participant Flow|Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second|Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days
624218|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
623864|NCT01055132|O2|Outcome|Nelfilcon A (Active Comparator)|An existing, daily disposable toric contact lens; worn for 5-9 days.
623865|NCT01055132|O1|Outcome|Etafilcon A (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
623866|NCT01055132|O2|Outcome|Nelfilcon A (Active Comparator)|An existing, daily disposable toric contact lens; worn for 5-9 days
623867|NCT01055132|O1|Outcome|Etafilcon A (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn 5-9 days
623868|NCT01055132|O2|Outcome|Nelfilcon A Toric Lens (Active Comparator)|An existing, daily disposable toric contact lens; worn 5-9 days
623869|NCT01055132|O1|Outcome|Etafilcon A Toric (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
623870|NCT01055132|O2|Outcome|Nelfilcon A Toric (Active Comparator)|An existing, daily disposable toric contact lens; worn 5-9 days
623871|NCT01055132|O1|Outcome|Etafilcon A Toric (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
623872|NCT01055132|E1|Reported Event|Etafilcon A Toric / Nelfilcon A Toric|etafilcon A toric contact lens worn daily during first period of a maximum of 9 days, nelfilcon A toric contact lens worn during second period of a maximum of 9 days
623873|NCT01055171|B3|Baseline|Total|Total of all reporting groups
623874|NCT01055171|B2|Baseline|Placebo|"Patient to receive placebo in this condition.
Placebo: 40 mg; Single Dose."
623875|NCT01055171|B1|Baseline|Propranolol|"Patients will receive Propranolol in this condition.
Propranolol: 40 mg; Single Administration."
623876|NCT01055171|P2|Participant Flow|Placebo|"Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
623934|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
623879|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
623880|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
623881|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
623882|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
623883|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
623884|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
623885|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
623886|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
623887|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
623888|NCT01055171|E2|Reported Event|Placebo|"Patient to receive placebo in this condition.
Placebo: 40 mg; Single Dose."
623889|NCT01055171|E1|Reported Event|Propranolol|"Patients will receive Propranolol in this condition.
Propranolol: 40 mg; Single Administration."
623890|NCT01055184|B1|Baseline|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
623891|NCT01055184|P1|Participant Flow|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
623892|NCT01055184|O1|Outcome|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
623893|NCT01055184|E1|Reported Event|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
623894|NCT01055197|B3|Baseline|Total|Total of all reporting groups
623895|NCT01055197|B2|Baseline|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
623896|NCT01055197|B1|Baseline|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
623897|NCT01055197|P2|Participant Flow|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
623898|NCT01055197|P1|Participant Flow|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
623899|NCT01055197|O2|Outcome|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
623900|NCT01055197|O1|Outcome|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
623901|NCT01055197|E2|Reported Event|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
623902|NCT01055197|E1|Reported Event|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
623903|NCT01055223|B1|Baseline|TZD 6-month Cohort (Including TZD 12-month Cohort)|The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.
623904|NCT01055223|P1|Participant Flow|TZD 6-month Cohort (Including TZD 12-month Cohort)|The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.
623905|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days
623906|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
623907|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
623908|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
623909|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days
623910|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
623911|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
623912|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
623913|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
623914|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
623915|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
623916|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
623917|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
623918|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
623919|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
623920|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
623921|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolacton, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
623922|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
623923|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
623924|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
623925|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
623926|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
623927|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected.
623928|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected.
623929|NCT01055223|E2|Reported Event|TZD-12 Month Cohort|The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.
623930|NCT01055223|E1|Reported Event|TZD 6-month Cohort|The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.
623931|NCT01055262|B1|Baseline|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
623932|NCT01055262|P1|Participant Flow|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
623933|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
623998|NCT01055613|B3|Baseline|Total|Total of all reporting groups
623935|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
623936|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
623937|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
623938|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
623939|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
623940|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
623941|NCT01055262|E1|Reported Event|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
623942|NCT01055314|B3|Baseline|Total|Total of all reporting groups
623943|NCT01055314|B2|Baseline|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
623944|NCT01055314|B1|Baseline|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
623945|NCT01055314|P2|Participant Flow|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
623946|NCT01055314|P1|Participant Flow|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
623947|NCT01055314|O2|Outcome|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
623948|NCT01055314|O1|Outcome|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
623949|NCT01055314|O2|Outcome|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
623950|NCT01055314|O1|Outcome|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
623951|NCT01055314|O2|Outcome|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
623952|NCT01055314|O1|Outcome|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
623953|NCT01055314|O1|Outcome|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
623954|NCT01055314|O1|Outcome|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
623955|NCT01055314|E2|Reported Event|Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)|"Patients receive vincristine sulfate, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin and undergo radiation therapy as in group 1. Patients also receive temozolomide PO on days 1-5 of weeks 1, 4, 20, 23, 47, and 50.
Cyclophosphamide: Given IV
Dactinomycin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Irinotecan Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Temozolomide: Given PO
Vincristine Sulfate Liposome: Given IV"
623956|NCT01055314|E1|Reported Event|Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)|"Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-5, 7, 8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50 & 51; irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 1, 4, 20, 23, 47 & 50; ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 9, 13, 17, 26, & 30; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 7, 11, 15, 28 & 32; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41 & 44; dactinomycin IV over 1-5 minutes on day 1 of weeks 35, 38, 41 & 44; and cixutumumab IV over 1 hour on day 1 of weeks 1-51. Patients also undergo radiation therapy on days 1-5 of weeks 20-24.
Cixutumumab: Given IV
Cyclophosphamide: Given IV
Dactinomycin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Irinotecan Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Vincristine Sulfate"
623957|NCT01055457|B1|Baseline|Dispensed Subjects|All subjects that were dispensed a study lens and solution.
623958|NCT01055457|P10|Participant Flow|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623959|NCT01055457|P9|Participant Flow|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623960|NCT01055457|P8|Participant Flow|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623961|NCT01055457|P7|Participant Flow|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623962|NCT01055457|P6|Participant Flow|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623963|NCT01055457|P5|Participant Flow|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623964|NCT01055457|P4|Participant Flow|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623965|NCT01055457|P3|Participant Flow|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623966|NCT01055457|P2|Participant Flow|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623967|NCT01055457|P1|Participant Flow|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623999|NCT01055613|B2|Baseline|ReNu Multi-purpose Solution|Marketed multi-purpose solution (Control Treatment).
623968|NCT01055457|O10|Outcome|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623969|NCT01055457|O9|Outcome|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623970|NCT01055457|O8|Outcome|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623971|NCT01055457|O7|Outcome|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623972|NCT01055457|O6|Outcome|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623973|NCT01055457|O5|Outcome|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623974|NCT01055457|O4|Outcome|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623975|NCT01055457|O3|Outcome|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623976|NCT01055457|O2|Outcome|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623977|NCT01055457|O1|Outcome|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623978|NCT01055457|O10|Outcome|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623979|NCT01055457|O9|Outcome|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623980|NCT01055457|O8|Outcome|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623981|NCT01055457|O7|Outcome|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623982|NCT01055457|O6|Outcome|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623983|NCT01055457|O5|Outcome|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623984|NCT01055457|O4|Outcome|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623985|NCT01055457|O3|Outcome|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623986|NCT01055457|O2|Outcome|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
624039|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
623987|NCT01055457|O1|Outcome|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623988|NCT01055457|E10|Reported Event|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623989|NCT01055457|E9|Reported Event|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623990|NCT01055457|E8|Reported Event|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623991|NCT01055457|E7|Reported Event|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623992|NCT01055457|E6|Reported Event|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
623993|NCT01055457|E5|Reported Event|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623994|NCT01055457|E4|Reported Event|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623995|NCT01055457|E3|Reported Event|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623996|NCT01055457|E2|Reported Event|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
623997|NCT01055457|E1|Reported Event|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
624000|NCT01055613|B1|Baseline|Experimental Mutli-purpose Solution|Experimental multi-purpose solution (Test treatment) .
624001|NCT01055613|P2|Participant Flow|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
624002|NCT01055613|P1|Participant Flow|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
624003|NCT01055613|O2|Outcome|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
624004|NCT01055613|O1|Outcome|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
624005|NCT01055613|O2|Outcome|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
624006|NCT01055613|O1|Outcome|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
624007|NCT01055613|E2|Reported Event|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
624008|NCT01055613|E1|Reported Event|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
624009|NCT01055639|B3|Baseline|Total|Total of all reporting groups
624010|NCT01055639|B2|Baseline|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624011|NCT01055639|B1|Baseline|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624012|NCT01055639|P2|Participant Flow|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624013|NCT01055639|P1|Participant Flow|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624014|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624015|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624016|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624017|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624214|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624018|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624019|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624020|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624021|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624022|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624023|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624024|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624245|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624025|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624026|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624027|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624028|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624029|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624030|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624031|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624032|NCT01055639|E2|Reported Event|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624033|NCT01055639|E1|Reported Event|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
624034|NCT01046084|B3|Baseline|Total|Total of all reporting groups
624035|NCT01046084|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
624036|NCT01046084|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 500 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
624037|NCT01046084|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
624038|NCT01046084|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 500 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
624040|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
624041|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
624042|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
624043|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
624044|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
624045|NCT01046084|E2|Reported Event|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
624046|NCT01046084|E1|Reported Event|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
624047|NCT01046110|B3|Baseline|Total|Total of all reporting groups
624048|NCT01046110|B2|Baseline|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
624049|NCT01046110|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
624050|NCT01046110|P2|Participant Flow|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
624051|NCT01046110|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
624052|NCT01046110|O2|Outcome|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
624177|NCT01046903|E1|Reported Event|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624053|NCT01046110|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
624054|NCT01046110|O2|Outcome|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
624055|NCT01046110|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
624056|NCT01046110|E2|Reported Event|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
624057|NCT01046110|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
624058|NCT01046136|B3|Baseline|Total|Total of all reporting groups
624059|NCT01046136|B2|Baseline|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
624060|NCT01046136|B1|Baseline|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
624061|NCT01046136|P2|Participant Flow|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
624062|NCT01046136|P1|Participant Flow|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
624063|NCT01046136|O2|Outcome|Placebo|Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
624064|NCT01046136|O1|Outcome|Mucinex|Two 600mg tablets taken taken twice daily
624065|NCT01046136|O2|Outcome|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
624066|NCT01046136|O1|Outcome|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
624067|NCT01046136|O2|Outcome|Placebo|Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
624068|NCT01046136|O1|Outcome|Mucinex|Two 600mg tablets taken taken twice daily
624069|NCT01046136|E2|Reported Event|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
624070|NCT01046136|E1|Reported Event|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
624071|NCT01046253|B3|Baseline|Total|Total of all reporting groups
624072|NCT01046253|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
624073|NCT01046253|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
624074|NCT01046253|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
624075|NCT01046253|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
624076|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
624077|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
624078|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
624079|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
624080|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
624081|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
624082|NCT01046253|E2|Reported Event|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
624083|NCT01046253|E1|Reported Event|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
624084|NCT01046396|B1|Baseline|Differin® Cream 0.1% and Differin® Lotion 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
624085|NCT01046396|P1|Participant Flow|Differin® Cream 0.1% and Differin® Lotion 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
624086|NCT01046396|O3|Outcome|No Preference|Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
624087|NCT01046396|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
624088|NCT01046396|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
624089|NCT01046396|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
624090|NCT01046396|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
624091|NCT01046396|E2|Reported Event|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
624092|NCT01046396|E1|Reported Event|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
624093|NCT01046565|B1|Baseline|Differin® Lotion 0.1% and Differin Cream 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
624178|NCT01047189|B3|Baseline|Total|Total of all reporting groups
624094|NCT01046565|P1|Participant Flow|Differin® Lotion 0.1% and Differin® Cream 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream - apply topically to the opposite site of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
624095|NCT01046565|O3|Outcome|No Preference|Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
624096|NCT01046565|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks
624097|NCT01046565|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
624098|NCT01046565|O2|Outcome|Differin Cream 0.1%|Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
624099|NCT01046565|O1|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
624100|NCT01046565|E2|Reported Event|Differin Cream 0.1%|Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
624101|NCT01046565|E1|Reported Event|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
624102|NCT01046643|B3|Baseline|Total|Total of all reporting groups
624103|NCT01046643|B2|Baseline|Progesterone and Placebo|"Progesterone treatment (P10)
Participants received both a Progesterone capsule (P10) (200 mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day)."
624104|NCT01046643|B1|Baseline|Estrogen and Placebo|"Estrogen treatment with Estradiol (E2)
Participants received both an Estradiol capsule (E2) (1mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day)."
624105|NCT01046643|P4|Participant Flow|Placebo Followed by Progesterone|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days.
624106|NCT01046643|P3|Participant Flow|Placebo Followed by Estrogen|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Estradiol capsule (E2) (1mg) once a day, at the same time each day, for 90 days.
624107|NCT01046643|P2|Participant Flow|Progesterone Followed by Placebo|"Progesterone (P10) treatment
One Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days, followed by one Placebo capsule once per day for 90 days, at the same time each day."
624108|NCT01046643|P1|Participant Flow|Estrogen Followed by Placebo|"Estrogen treatment with Estradiol (E2)
One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days followed by one Placebo capsule once per day for 90 days, at the same time each day"
624109|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment
One Placebo capsule once a day, at the same time each day, for 90 days"
624110|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment
One Placebo capsule once a day, at the same time each day, for 90 days"
624111|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment
Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
624112|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)
Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
624215|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624113|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment
One Placebo capsule once a day, at the same time each day, for 90 days"
624114|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment
One Placebo capsule once a day, at the same time each day, for 90 days"
624115|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment
Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
624116|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)
Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
624117|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment
One Placebo capsule once a day, at the same time each day, for 90 days"
624118|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment
One Placebo capsule once a day, at the same time each day, for 90 days"
624119|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment
Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
624120|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)
Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
624121|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment
One Placebo capsule once a day, at the same time each day, for 90 days"
624122|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment
One Placebo capsule once a day, at the same time each day, for 90 days"
624123|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment
Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
624124|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)
Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
624125|NCT01046643|E4|Reported Event|Placebo Followed by Progesterone|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days.
624126|NCT01046643|E3|Reported Event|Placebo Followed by Estrogen|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Estradiol capsule (E2) (1mg) capsule once a day, at the same time each day, for 90 days.
624179|NCT01047189|B2|Baseline|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
624312|NCT01048099|O1|Outcome|All Patients|
624127|NCT01046643|E2|Reported Event|Progesterone Followed by Placebo|"Progesterone treatment
One Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days, followed by one Placebo capsule once per day for 90 days, at the same time each day."
624128|NCT01046643|E1|Reported Event|Estrogen Followed by Placebo|"Estrogen treatment with Estradiol (E2)
One Estradiol capsule (E2) (1mg) once a day, at the same time each day, for 90 days followed by one Placebo capsule once per day for 90 days, at the same time each day."
624129|NCT01046682|B3|Baseline|Total|Total of all reporting groups
624130|NCT01046682|B2|Baseline|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
624131|NCT01046682|B1|Baseline|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
624132|NCT01046682|P2|Participant Flow|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
624133|NCT01046682|P1|Participant Flow|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
624134|NCT01046682|O2|Outcome|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
624135|NCT01046682|O1|Outcome|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
624136|NCT01046682|E2|Reported Event|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
624137|NCT01046682|E1|Reported Event|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
624138|NCT01046695|B3|Baseline|Total|Total of all reporting groups
624139|NCT01046695|B2|Baseline|Control Arm|This arm will have standard care for their post operative pain control.
624140|NCT01046695|B1|Baseline|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.
Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
624141|NCT01046695|P2|Participant Flow|TENS Unit|Once awake from surgery this arm added the use of the TENS unit for 48 hours in addition to standard care for their postoperative pain control. The TENS unit was set to each patients individual preference which included intensity, frequency and the placement of where they wanted the electrodes.
624142|NCT01046695|P1|Participant Flow|Control Arm|Once awake from surgery this arm had standard care for 48 hours for their postoperative pain control using each surgeons usual postoperative medications and procedures.
624143|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
624216|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624144|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.
Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
624145|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
624146|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.
Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
624147|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
624148|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.
Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
624149|NCT01046695|E2|Reported Event|Control Arm|This arm will have standard care for their post operative pain control.
624150|NCT01046695|E1|Reported Event|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.
Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
624180|NCT01047189|B1|Baseline|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
624181|NCT01047189|P2|Participant Flow|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
624151|NCT01046877|B1|Baseline|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624152|NCT01046877|P1|Participant Flow|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624153|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624154|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624155|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624156|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624157|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624158|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624159|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624160|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624161|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624217|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624162|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624163|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624164|NCT01046877|E1|Reported Event|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
624165|NCT01046903|B1|Baseline|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624166|NCT01046903|P1|Participant Flow|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 International Unit (IU)/0.2 milliliter (mL) and 5000 IU/2 mL subcutaneously (s.c) as per registered indications for 5 weeks.
624167|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624168|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624169|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624170|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624171|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624172|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624173|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624174|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624175|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624176|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
624182|NCT01047189|P1|Participant Flow|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
624183|NCT01047189|O2|Outcome|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
624184|NCT01047189|O1|Outcome|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
624185|NCT01047189|O2|Outcome|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
624186|NCT01047189|O1|Outcome|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
624187|NCT01047189|E2|Reported Event|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
624188|NCT01047189|E1|Reported Event|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
624189|NCT01047527|B4|Baseline|Total|Total of all reporting groups
624190|NCT01047527|B3|Baseline|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
624191|NCT01047527|B2|Baseline|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
624192|NCT01047527|B1|Baseline|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
624193|NCT01047527|P3|Participant Flow|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
624194|NCT01047527|P2|Participant Flow|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
624195|NCT01047527|P1|Participant Flow|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
624196|NCT01047527|O2|Outcome|Extended + Maintenance|
624197|NCT01047527|O1|Outcome|Standard|
624198|NCT01047527|O2|Outcome|Maintenance|Participants on 52 weeks of therapy
624199|NCT01047527|O1|Outcome|Standard + Extended|participants on standard or extended therapy
624200|NCT01047527|E3|Reported Event|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
624201|NCT01047527|E2|Reported Event|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
624202|NCT01047527|E1|Reported Event|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
624203|NCT01047553|B3|Baseline|Total|Total of all reporting groups
624204|NCT01047553|B2|Baseline|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624205|NCT01047553|B1|Baseline|Formoterol|Formoterol 9 μg twice daily
624206|NCT01047553|P2|Participant Flow|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624207|NCT01047553|P1|Participant Flow|Formoterol|Formoterol 9 μg twice daily
624208|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624209|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624210|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624211|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624212|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624213|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624829|NCT01055704|O2|Outcome|Codeine 30 mg|
624219|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624220|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624221|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624222|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624223|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624224|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624225|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624226|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624227|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624228|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624229|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624230|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624231|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624232|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624233|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624234|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624235|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624236|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624237|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624238|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624239|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624240|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624241|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624242|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624243|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624246|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624247|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624248|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624249|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624250|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624251|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624252|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624253|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624254|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624255|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624256|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624257|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624258|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624259|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624260|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624261|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624262|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624263|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624264|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624265|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624266|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624267|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624268|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624269|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624270|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624271|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624272|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624273|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624274|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624275|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624276|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624277|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624278|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624279|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624280|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624281|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624282|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624283|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624284|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624285|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
624286|NCT01047553|E2|Reported Event|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
624287|NCT01047553|E1|Reported Event|Formoterol|Formoterol 9 μg twice daily
624288|NCT01047709|B1|Baseline|All Study Participants|All study participants.
624289|NCT01047709|P2|Participant Flow|Control Night First, Then Positional Therapy Night|Position ad lib for the first night, then one night of avoidance of supine positioning.
624290|NCT01047709|P1|Participant Flow|Positional Therapy Night First, Then Control Night|Avoidance of supine positioning on the first night, followed by a second night of positioning ad lib.
624291|NCT01047709|O2|Outcome|Control Night|Position ad lib
624292|NCT01047709|O1|Outcome|Positional Therapy Night|Avoidance of supine positioning.
624293|NCT01047709|E2|Reported Event|Control Night|Position ad lib
624294|NCT01047709|E1|Reported Event|Positional Therapy Night|Avoidance of supine positioning.
624295|NCT01047839|B4|Baseline|Total|Total of all reporting groups
624296|NCT01047839|B3|Baseline|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
624297|NCT01047839|B2|Baseline|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
624298|NCT01047839|B1|Baseline|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m.vaccinations at Day 0 and Day 28
624299|NCT01047839|P3|Participant Flow|>=12 to <18 Years|IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
624300|NCT01047839|P2|Participant Flow|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
624301|NCT01047839|P1|Participant Flow|>=2 Months to <3 Years|IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
624302|NCT01047839|O3|Outcome|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
624303|NCT01047839|O2|Outcome|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
624304|NCT01047839|O1|Outcome|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
624305|NCT01047839|E3|Reported Event|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
624306|NCT01047839|E2|Reported Event|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
624307|NCT01047839|E1|Reported Event|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
624308|NCT01048099|B1|Baseline|Patients Treated|Patients who received study treatment
624309|NCT01048099|P1|Participant Flow|All Patients|
624310|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
624311|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
624313|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
624314|NCT01048099|O1|Outcome|All Patients Evaluated by PRO Onc Assay|
624315|NCT01048099|E1|Reported Event|All Treated Patients|Includes all patients with HER2 overexpression/activation (as identified by the PRO Onc Assay) who received study treatment
624316|NCT01048125|B3|Baseline|Total|Total of all reporting groups
624317|NCT01048125|B2|Baseline|Control|Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
624318|NCT01048125|B1|Baseline|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
624319|NCT01048125|P2|Participant Flow|Control|"Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity
Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word green is written in blue ink, they will say blue. This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.
The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride"
624320|NCT01048125|P1|Participant Flow|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
624321|NCT01048125|O2|Outcome|Control|"Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity
Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word green is written in blue ink, they will say blue. This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.
The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride"
624322|NCT01048125|O1|Outcome|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
624323|NCT01048125|E2|Reported Event|Control|Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
624324|NCT01048125|E1|Reported Event|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
624325|NCT01048242|B3|Baseline|Total|Total of all reporting groups
624326|NCT01048242|B2|Baseline|Sugar Pill|
624327|NCT01048242|B1|Baseline|Ramelteon|Ramelteon 8 mg oral before bedtime
624328|NCT01048242|P2|Participant Flow|Sugar Pill|
624329|NCT01048242|P1|Participant Flow|Ramelteon|Ramelteon 8 mg oral before bedtime
624330|NCT01048242|O2|Outcome|Sugar Pill|
624331|NCT01048242|O1|Outcome|Ramelteon|Ramelteon 8 mg oral before bedtime
624332|NCT01048242|E2|Reported Event|Sugar Pill|
624333|NCT01048242|E1|Reported Event|Ramelteon|Ramelteon 8 mg oral before bedtime
624334|NCT01048333|B1|Baseline|Entire Study Population|Includes all 3 arms : Formoterol, Salmeterol and Placebo.
624335|NCT01048333|P6|Participant Flow|Placebo, Then Salmeterol, Then Formoterol|Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
624336|NCT01048333|P5|Participant Flow|Salmeterol, Then Formoterol, Then Placebo|Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler
624337|NCT01048333|P4|Participant Flow|Formoterol, Then Placebo, Then Salmeterol|Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
624338|NCT01048333|P3|Participant Flow|Placebo, Then Formoterol, Then Salmeterol|Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
624339|NCT01048333|P2|Participant Flow|Salmeterol, Then Palcebo, Then Formoterol|Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
624340|NCT01048333|P1|Participant Flow|Formoterol, Then Salmeterol, Then Placebo|Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
624341|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
624342|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
624343|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
624344|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
624345|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
624346|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
624347|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
624348|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
624349|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
624350|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
624351|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
624352|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
624353|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
624354|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
624355|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
624356|NCT01048333|E3|Reported Event|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
624357|NCT01048333|E2|Reported Event|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
624358|NCT01048333|E1|Reported Event|Formoterol|Formoterol Turbuhaler 9 mcg
624359|NCT01048424|B3|Baseline|Total|Total of all reporting groups
624360|NCT01048424|B2|Baseline|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624361|NCT01048424|B1|Baseline|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624362|NCT01048424|P2|Participant Flow|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624363|NCT01048424|P1|Participant Flow|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624364|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624365|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624366|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624367|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624368|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624369|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624370|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624371|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624372|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624830|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
624373|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624374|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624375|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624376|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624377|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624378|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624379|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624380|NCT01048424|O2|Outcome|Control|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624381|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624382|NCT01048424|E2|Reported Event|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624406|NCT01048541|O1|Outcome|Test Catheter|Test catheter (SpeediCath Compact Male)
624383|NCT01048424|E1|Reported Event|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
624384|NCT01048502|B5|Baseline|Total|Total of all reporting groups
624385|NCT01048502|B4|Baseline|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
624386|NCT01048502|B3|Baseline|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
624387|NCT01048502|B2|Baseline|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
624388|NCT01048502|B1|Baseline|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.
Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
624389|NCT01048502|P4|Participant Flow|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
624390|NCT01048502|P3|Participant Flow|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
624391|NCT01048502|P2|Participant Flow|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
624392|NCT01048502|P1|Participant Flow|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.
Fenofibrate (Tricor) tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
624393|NCT01048502|O2|Outcome|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
624394|NCT01048502|O1|Outcome|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.
Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
624395|NCT01048502|O3|Outcome|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
624529|NCT01048944|P2|Participant Flow|Nicotine Patch|"21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
624396|NCT01048502|O2|Outcome|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
624397|NCT01048502|O1|Outcome|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
624398|NCT01048502|E4|Reported Event|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
624399|NCT01048502|E3|Reported Event|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
624400|NCT01048502|E2|Reported Event|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
624401|NCT01048502|E1|Reported Event|Tricor (145 mg/Day)|"Participants will be given 1 Tricor 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.
Fenofibrate tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
624402|NCT01048541|B1|Baseline|Entire Study|Includes groups randomized to standard catheter first and test catheter first
624403|NCT01048541|P2|Participant Flow|BA: First Standard Catheter Then Test Catheter|Standard catheter (SpediCath straight)used in the first period and test catheter (SpeediCath Compact Male) used in the second period
624404|NCT01048541|P1|Participant Flow|AB: First Test Catheter Then Standard Catheter|Test catheter (SpeediCath Compact Male)used in the first period and Standard catheter (SpediCath straight) used in the second period
624405|NCT01048541|O2|Outcome|Standard Catheter|Standard catheter (SpediCath straight)
624407|NCT01048541|E2|Reported Event|Standard Catheter|Standard catheter (SpediCath straight)
624408|NCT01048541|E1|Reported Event|Test Catheter|Test catheter (SpeediCath Compact Male)
624409|NCT01048593|B4|Baseline|Total|Total of all reporting groups
624410|NCT01048593|B3|Baseline|Dose 3|684ug dose group
624411|NCT01048593|B2|Baseline|Dose 2|513ug dose group
624412|NCT01048593|B1|Baseline|Dose 1|114ug dose group
624413|NCT01048593|P3|Participant Flow|Dose 3|684ug dose group
624414|NCT01048593|P2|Participant Flow|Dose 2|513ug dose group
624415|NCT01048593|P1|Participant Flow|Dose 1|114ug dose group
624416|NCT01048593|O3|Outcome|Dose 3|684ug dose group
624417|NCT01048593|O2|Outcome|Dose 2|513ug dose group
624418|NCT01048593|O1|Outcome|Dose 1|114ug dose group
624419|NCT01048593|E3|Reported Event|Dose 3|684ug dose group
624420|NCT01048593|E2|Reported Event|Dose 2|513ug dose group
624421|NCT01048593|E1|Reported Event|Dose 1|114ug dose group
624422|NCT01048606|B5|Baseline|Total|Total of all reporting groups
624423|NCT01048606|B4|Baseline|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
624424|NCT01048606|B3|Baseline|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)
Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.
Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
624425|NCT01048606|B2|Baseline|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)
Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.
Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
624426|NCT01048606|B1|Baseline|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)
Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)
Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
624427|NCT01048606|P4|Participant Flow|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
624463|NCT01048671|O1|Outcome|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624831|NCT01055704|E4|Reported Event|Placebo|
624428|NCT01048606|P3|Participant Flow|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)
Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.
Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
624429|NCT01048606|P2|Participant Flow|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)
Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.
Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
624430|NCT01048606|P1|Participant Flow|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)
Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)
Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
624431|NCT01048606|O4|Outcome|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
624449|NCT01048658|O1|Outcome|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
624450|NCT01048658|O2|Outcome|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.
No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
624500|NCT01048788|O3|Outcome|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
624501|NCT01048788|O2|Outcome|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
624432|NCT01048606|O3|Outcome|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)
Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.
Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
624433|NCT01048606|O2|Outcome|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)
Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.
Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
624434|NCT01048606|O1|Outcome|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)
Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)
Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
624435|NCT01048606|E4|Reported Event|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
624436|NCT01048606|E3|Reported Event|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)
Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.
Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
624437|NCT01048606|E2|Reported Event|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)
Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.
Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
624832|NCT01055704|E3|Reported Event|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
624833|NCT01055704|E2|Reported Event|Codeine 30 mg|
624438|NCT01048606|E1|Reported Event|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)
Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)
Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
624439|NCT01048658|B3|Baseline|Total|Total of all reporting groups
624440|NCT01048658|B2|Baseline|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.
No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
624441|NCT01048658|B1|Baseline|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
624442|NCT01048658|P2|Participant Flow|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.
No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
624443|NCT01048658|P1|Participant Flow|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
624444|NCT01048658|O2|Outcome|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.
No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
624445|NCT01048658|O1|Outcome|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
624446|NCT01048658|O2|Outcome|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.
No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
624447|NCT01048658|O1|Outcome|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
624448|NCT01048658|O2|Outcome|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.
No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
624498|NCT01048788|P2|Participant Flow|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
625100|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
624451|NCT01048658|O1|Outcome|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
624452|NCT01048658|O2|Outcome|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.
No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
624453|NCT01048658|O1|Outcome|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
624454|NCT01048658|E2|Reported Event|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.
No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
624455|NCT01048658|E1|Reported Event|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
624456|NCT01048671|B4|Baseline|Total|Total of all reporting groups
624457|NCT01048671|B3|Baseline|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
624458|NCT01048671|B2|Baseline|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
624459|NCT01048671|B1|Baseline|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624460|NCT01048671|P3|Participant Flow|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624461|NCT01048671|P2|Participant Flow|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 ribonucleic acid (RNA) copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624462|NCT01048671|P1|Participant Flow|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624530|NCT01048944|P1|Participant Flow|Bupropion Sustained Release (SR)|"150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
624464|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624465|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624466|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624467|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624468|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624469|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624470|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624471|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624472|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624473|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624499|NCT01048788|P1|Participant Flow|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
627982|NCT01059760|O1|Outcome|Baseline Value|
624474|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624475|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624476|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624477|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624478|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624479|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624480|NCT01048671|O1|Outcome|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624481|NCT01048671|E1|Reported Event|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
624482|NCT01048697|B1|Baseline|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):
40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
624483|NCT01048697|P1|Participant Flow|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):
40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
624528|NCT01048944|P3|Participant Flow|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
624484|NCT01048697|O1|Outcome|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):
40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
624485|NCT01048697|E1|Reported Event|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):
40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
624486|NCT01048723|B1|Baseline|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
624487|NCT01048723|P1|Participant Flow|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
624488|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
624489|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
624490|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
624491|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
624492|NCT01048723|E1|Reported Event|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
624493|NCT01048788|B4|Baseline|Total|Total of all reporting groups
624494|NCT01048788|B3|Baseline|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
624495|NCT01048788|B2|Baseline|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
624496|NCT01048788|B1|Baseline|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
624497|NCT01048788|P3|Participant Flow|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
624502|NCT01048788|O1|Outcome|Discontitued/Terminated Before Day 8|Subjects who discontinued treatment before Day 7 or teiminated by meeting the criteria on Day 7
624503|NCT01048788|E3|Reported Event|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
624504|NCT01048788|E2|Reported Event|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
624505|NCT01048788|E1|Reported Event|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
624506|NCT01048879|B4|Baseline|Total|Total of all reporting groups
624507|NCT01048879|B3|Baseline|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
624508|NCT01048879|B2|Baseline|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
624509|NCT01048879|B1|Baseline|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
624510|NCT01048879|P3|Participant Flow|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
624511|NCT01048879|P2|Participant Flow|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
624512|NCT01048879|P1|Participant Flow|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
624513|NCT01048879|O3|Outcome|ECMO Alone|Patients receiving ECMO only
624514|NCT01048879|O2|Outcome|CVVHD + ECMO|Patients receiving oseltamivir and ECMO and CVVHD
624515|NCT01048879|O1|Outcome|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
624516|NCT01048879|O3|Outcome|ECMO Alone|Patients receiving ECMO only
624517|NCT01048879|O2|Outcome|CVVHD + ECMO|Patients receiving oseltamivir and ECMO and CVVHD
624518|NCT01048879|O1|Outcome|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
624519|NCT01048879|E3|Reported Event|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
624520|NCT01048879|E2|Reported Event|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
624521|NCT01048879|E1|Reported Event|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
624522|NCT01048944|B5|Baseline|Total|Total of all reporting groups
624523|NCT01048944|B4|Baseline|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
624524|NCT01048944|B3|Baseline|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
624525|NCT01048944|B2|Baseline|Nicotine Patch|"21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
624526|NCT01048944|B1|Baseline|Bupropion SR|"150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
624527|NCT01048944|P4|Participant Flow|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
624531|NCT01048944|O4|Outcome|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
624532|NCT01048944|O3|Outcome|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
624533|NCT01048944|O2|Outcome|Bupropion SR|"150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
624534|NCT01048944|O1|Outcome|Nicotine Patch|"21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
624535|NCT01048944|O4|Outcome|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
624536|NCT01048944|O3|Outcome|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
624537|NCT01048944|O2|Outcome|Bupropion SR|"150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
624538|NCT01048944|O1|Outcome|Nicotine Patch|"21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
624539|NCT01048944|E4|Reported Event|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
624540|NCT01048944|E3|Reported Event|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56 days at 2x/day, then 3 days at 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
624541|NCT01048944|E2|Reported Event|Nicotine Patch|"21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
624542|NCT01048944|E1|Reported Event|Bupropion SR|"150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill, 3 days 1x/day then 56 days at 2x/day, then 3 day at 1x/day ramp-down."
624543|NCT01049009|B3|Baseline|Total|Total of all reporting groups
624544|NCT01049009|B2|Baseline|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
624545|NCT01049009|B1|Baseline|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
624546|NCT01049009|P2|Participant Flow|Metoprolol XL/Nebivolol|Subjects are randomized to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after cross over.
624547|NCT01049009|P1|Participant Flow|Nebivolol/Metoprolol XL|Subjects are randomized to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after cross over.
624548|NCT01049009|O2|Outcome|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
624549|NCT01049009|O1|Outcome|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
624550|NCT01049009|O2|Outcome|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
624551|NCT01049009|O1|Outcome|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
624552|NCT01049009|E2|Reported Event|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
624553|NCT01049009|E1|Reported Event|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
624554|NCT01049217|B3|Baseline|Total|Total of all reporting groups
624555|NCT01049217|B2|Baseline|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624556|NCT01049217|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624687|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
624688|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
624834|NCT01055704|E1|Reported Event|Methylnaltrexone 0.30 mg/kg|
624557|NCT01049217|P2|Participant Flow|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624558|NCT01049217|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624559|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624560|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624650|NCT01049360|P9|Participant Flow|Sequence 9|Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium - Placebo
624651|NCT01049360|P8|Participant Flow|Sequence 8|Aclidinium - Placebo - Aclidinium/Formoterol 400/12 - Formoterol
624652|NCT01049360|P7|Participant Flow|Sequence 7|Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium
624653|NCT01049360|P6|Participant Flow|Sequence 6|Aclidinium/Formoterol 400/6 - Aclidinium - Placebo - Aclidinium/Formoterol 400/12
625101|NCT01056380|E2|Reported Event|Placebo|Placebo : Tablet, twice daily with food for 5 days
624561|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624562|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624563|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624564|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624565|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624721|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
627381|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
624566|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624567|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624568|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624569|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624570|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624654|NCT01049360|P5|Participant Flow|Sequence 5|Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12 - Aclidinium
624655|NCT01049360|P4|Participant Flow|Sequence 4|Formoterol - Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12
624571|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624572|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624573|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624574|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624575|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624576|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624577|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624578|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624579|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624580|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624656|NCT01049360|P3|Participant Flow|Sequence 3|Aclidinium - Formoterol - Placebo - Aclidinium/Formoterol 400/6
624657|NCT01049360|P2|Participant Flow|Sequence 2|Aclidinium/Formoterol 400/12 - Aclidinium - Formoterol - Placebo
624581|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624582|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624583|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624584|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624585|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624586|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624587|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624588|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624589|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624590|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624658|NCT01049360|P1|Participant Flow|Sequence 1|Aclidiunium/Formoterol 400/6 - Aclidiunium/Formoterol 400/12 - Aclidinium - Formoterol
624659|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
624660|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
624591|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624592|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624593|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624594|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624595|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624596|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624597|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624598|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624599|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624600|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624661|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
624662|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
624601|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624602|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624603|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624604|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624605|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624606|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624607|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624608|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624609|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624610|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624663|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
624664|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
624611|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624612|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624613|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624614|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624615|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624616|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624617|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624618|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624619|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624620|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624665|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
624666|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
627983|NCT01059760|O3|Outcome|Change When Fed|
624621|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624622|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624623|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624624|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624625|NCT01049217|E2|Reported Event|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624626|NCT01049217|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
624627|NCT01049243|B1|Baseline|Single Group|
624628|NCT01049243|P1|Participant Flow|Vanos|Single group; 0.1% Cream, One Application, Twice Daily, 14 Days
624629|NCT01049243|O1|Outcome|Single Group|
624630|NCT01049243|E1|Reported Event|Single Group|
624631|NCT01049308|B1|Baseline|Group 1|veteran population with documented heart failure
624632|NCT01049308|P1|Participant Flow|Heart Failure|veteran population with documented heart failure
624633|NCT01049308|O3|Outcome|Severe CI|veteran population with documented heart failure with severe cognitive impairment (dementia) on SLUMS screening test who finished 30-day pill counts
624634|NCT01049308|O2|Outcome|Mild CI|veteran population with documented heart failure with mild cognitive impairment on SLUMS screening test who finished 30-day pill counts
624635|NCT01049308|O1|Outcome|No CI|veteran population with documented heart failure with no cognitive impairment on SLUMS screening test who finished 30-day pill counts
624636|NCT01049308|O1|Outcome|Heart Failure|veteran population with documented heart failure
624637|NCT01049308|E1|Reported Event|Group 1|veteran population with documented heart failure
624638|NCT01049360|B1|Baseline|Overall Population|Safety population defined as all randomized patients who took at least one dose of double-blind investigational product
624639|NCT01049360|P20|Participant Flow|Sequence 20|Placebo - Formoterol - Aclidinium - Aclidinium/Formoterol 400/12
624640|NCT01049360|P19|Participant Flow|Sequence 19|Formoterol - Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6
624641|NCT01049360|P18|Participant Flow|Sequence 18|Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo
624642|NCT01049360|P17|Participant Flow|Sequence 17|Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo - Formoterol
624643|NCT01049360|P16|Participant Flow|Sequence 16|Aclidinium/Formoterol 400/6 - Placebo - Formoterol - Aclidinium
624644|NCT01049360|P15|Participant Flow|Sequence 15|Placebo - Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol
624645|NCT01049360|P14|Participant Flow|Sequence 14|Formoterol - Aclidinium/Formoterol 400/12 - Placebo - Aclidinium
624646|NCT01049360|P13|Participant Flow|Sequence 13|Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12
624647|NCT01049360|P12|Participant Flow|Sequence 12|Aclidinium/Formoterol 400/12 - Placebo - Aclidinium - Aclidinium/Formoterol 400/6
624648|NCT01049360|P11|Participant Flow|Sequence 11|Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12 - Placebo
624649|NCT01049360|P10|Participant Flow|Sequence 10|Placebo - Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6
624667|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
624668|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
624669|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
624670|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
624671|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
624672|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
624673|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
624674|NCT01049360|E5|Reported Event|Placebo|Placebo twice-daily
624675|NCT01049360|E4|Reported Event|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
624676|NCT01049360|E3|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
624677|NCT01049360|E2|Reported Event|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
624678|NCT01049360|E1|Reported Event|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
624679|NCT01049373|B3|Baseline|Total|Total of all reporting groups
624680|NCT01049373|B2|Baseline|Placebo Solution|10 drops t.i.d. for 15 weeks
624681|NCT01049373|B1|Baseline|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
624682|NCT01049373|P2|Participant Flow|Placebo Solution|10 drops t.i.d. for 15 weeks
624683|NCT01049373|P1|Participant Flow|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
624684|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
624685|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
624686|NCT01049373|O2|Outcome|PLACEBO Solution|10 drops t.i.d. for 15 weeks
624722|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624689|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
624690|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
624691|NCT01049373|O1|Outcome|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
624692|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
624693|NCT01049373|O1|Outcome|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
624694|NCT01049373|E2|Reported Event|Placebo Solution|10 drops t.i.d. for 15 weeks
624695|NCT01049373|E1|Reported Event|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
624696|NCT01049503|B7|Baseline|Total|Total of all reporting groups
624697|NCT01049503|B6|Baseline|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
624698|NCT01049503|B5|Baseline|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
624699|NCT01049503|B4|Baseline|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
624700|NCT01049503|B3|Baseline|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624701|NCT01049503|B2|Baseline|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624702|NCT01049503|B1|Baseline|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624703|NCT01049503|P6|Participant Flow|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
624847|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624704|NCT01049503|P5|Participant Flow|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
624705|NCT01049503|P4|Participant Flow|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
624706|NCT01049503|P3|Participant Flow|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624707|NCT01049503|P2|Participant Flow|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624708|NCT01049503|P1|Participant Flow|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624709|NCT01049503|O3|Outcome|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624710|NCT01049503|O2|Outcome|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624711|NCT01049503|O1|Outcome|Caries-inactive 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624712|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624713|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624714|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624715|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624716|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624717|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624718|NCT01049503|O3|Outcome|1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
624719|NCT01049503|O2|Outcome|550 Ppm F, pH 4.5|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
624720|NCT01049503|O1|Outcome|550 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
624723|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624724|NCT01049503|O3|Outcome|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624725|NCT01049503|O2|Outcome|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624726|NCT01049503|O1|Outcome|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624727|NCT01049503|O3|Outcome|1100 ppmF , pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
624728|NCT01049503|O2|Outcome|550 Ppm F, pH 4.5|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
624729|NCT01049503|O1|Outcome|550 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
624730|NCT01049503|E6|Reported Event|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
624731|NCT01049503|E5|Reported Event|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
624732|NCT01049503|E4|Reported Event|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
624733|NCT01049503|E3|Reported Event|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624734|NCT01049503|E2|Reported Event|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624735|NCT01049503|E1|Reported Event|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
624736|NCT01049581|B3|Baseline|Total|Total of all reporting groups
624848|NCT01055769|E2|Reported Event|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624737|NCT01049581|B2|Baseline|Conventional Therapy Group|The participants were classified into the control (conventional therapy) group according to preference. The children included in the control group continued with their original rehabilitation programs.
624738|NCT01049581|B1|Baseline|Pediatric Aquatic Therapy Group|The participants were classified into two groups the pediatric aquatic therapy group according the their preference. The children of the PAT group participated in a 1 hour/time, twice-per-week, 12-week, PAT program in addition to conventional rehabilitation programs.
624739|NCT01049581|P2|Participant Flow|Conventional Therapy Group|*Children diagnosed with cerebral palsy, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the conventional therapy according to preference
624740|NCT01049581|P1|Participant Flow|Pediatric Aquatic Therapy Group|*Children diagnosed with cerebral palsy, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the pediatric aquatic therapy according to preference
624741|NCT01049581|O2|Outcome|Conventional Therapy|Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV, participate conventional therapy according preference
624742|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|*Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV, participate pediatric aquatic therapy according preference
624743|NCT01049581|O2|Outcome|Conventional Therapy|14 children diagnosed as spastic type cerebral palsy participate conventional therapy and 13 children finish the study,each of them fulfill the the questionnaire before and after the intervention
624744|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|13 children diagnosed as spastic type cerebral palsy participate pediatric auqatic therapy and 11 children finish the study,each of them fulfill the the questionnaire before and after the intervention
624745|NCT01049581|O2|Outcome|Conventional Therapy|Initially 14 children diagnosed as spastic cerebral palsy participate conventional therapy according to preference and 13 children complete the study
624746|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|13 children diagnosed as spastic cerebral palsy participate to pediatric aquatic therapy according preference and finally 11 children complete the study
624747|NCT01049581|E1|Reported Event|Effects of Pediatric Aquatic Therapy on Motor Performance|*Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I–IV,
624748|NCT01049776|B1|Baseline|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
624749|NCT01049776|P1|Participant Flow|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
624750|NCT01049776|O1|Outcome|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
624751|NCT01049776|E1|Reported Event|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
624752|NCT01049802|B3|Baseline|Total|Total of all reporting groups
624753|NCT01049802|B2|Baseline|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624773|NCT01049945|P5|Participant Flow|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624754|NCT01049802|B1|Baseline|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624755|NCT01049802|P2|Participant Flow|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624756|NCT01049802|P1|Participant Flow|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624757|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624758|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624759|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624760|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624761|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624762|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624763|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624764|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624765|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624766|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624767|NCT01049802|E2|Reported Event|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624768|NCT01049802|E1|Reported Event|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
624769|NCT01049945|B3|Baseline|Total|Total of all reporting groups
624770|NCT01049945|B2|Baseline|Maximum Tolerated Dose, Dose Level 4|Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
624771|NCT01049945|B1|Baseline|Phase I|Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
624772|NCT01049945|P6|Participant Flow|Phase II, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624825|NCT01055704|O2|Outcome|Codeine 30 mg|
624826|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
624774|NCT01049945|P4|Participant Flow|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624775|NCT01049945|P3|Participant Flow|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624776|NCT01049945|P2|Participant Flow|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624777|NCT01049945|P1|Participant Flow|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624778|NCT01049945|O1|Outcome|Maximum Tolerated Dose, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
624779|NCT01049945|O5|Outcome|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624780|NCT01049945|O4|Outcome|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624781|NCT01049945|O3|Outcome|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624782|NCT01049945|O2|Outcome|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624783|NCT01049945|O1|Outcome|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624784|NCT01049945|E6|Reported Event|Phase II, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
625199|NCT01056653|B1|Baseline|Group A Teal|"Two intervention home visits
Standard Dose: Two home visits"
624785|NCT01049945|E5|Reported Event|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624786|NCT01049945|E4|Reported Event|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624787|NCT01049945|E3|Reported Event|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624788|NCT01049945|E2|Reported Event|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624789|NCT01049945|E1|Reported Event|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
624790|NCT01055704|B5|Baseline|Total|Total of all reporting groups
624791|NCT01055704|B4|Baseline|Placebo|
624792|NCT01055704|B3|Baseline|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
624793|NCT01055704|B2|Baseline|Codeine 30 mg|
624794|NCT01055704|B1|Baseline|Methylnaltrexone 0.30 mg/kg|
624795|NCT01055704|P4|Participant Flow|Placebo|
624796|NCT01055704|P3|Participant Flow|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
624797|NCT01055704|P2|Participant Flow|Codeine 30 mg|
624798|NCT01055704|P1|Participant Flow|Methylnaltrexone 0.30 mg/kg|
624799|NCT01055704|O4|Outcome|Placebo|
624800|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
624801|NCT01055704|O2|Outcome|Codeine 30 mg|
624802|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
624803|NCT01055704|O4|Outcome|Placebo|
624804|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
624805|NCT01055704|O2|Outcome|Codeine 30 mg|
624806|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
624807|NCT01055704|O4|Outcome|Placebo|
624808|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
624809|NCT01055704|O2|Outcome|Codeine 30 mg|
624810|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
624811|NCT01055704|O4|Outcome|Placebo|
624812|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
624813|NCT01055704|O2|Outcome|Codeine 30 mg|
624814|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
624815|NCT01055704|O4|Outcome|Placebo|
624816|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
624817|NCT01055704|O2|Outcome|Codeine 30 mg|
624818|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
624819|NCT01055704|O4|Outcome|Placebo|
624820|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
624821|NCT01055704|O2|Outcome|Codeine 30 mg|
624822|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
624823|NCT01055704|O4|Outcome|Placebo|
624824|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
624835|NCT01055769|B1|Baseline|Linezolid|Linezolid 600 mg once (oral suspension or tablet) in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624836|NCT01055769|P2|Participant Flow|Linezolid 600 mg Tablet, Then Linezolid 600 mg Oral Suspension|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).
624837|NCT01055769|P1|Participant Flow|Linezolid 600 mg Oral Suspension, Then Linezolid 600 mg Tablet|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).
624838|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624839|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624840|NCT01055769|O2|Outcome|Linezolid 600mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624841|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624842|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624843|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624844|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624845|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624846|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624849|NCT01055769|E1|Reported Event|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
624850|NCT01055782|B3|Baseline|Total|Total of all reporting groups
624851|NCT01055782|B2|Baseline|Without Endoguide|Colonoscopy completed without endoguide
624852|NCT01055782|B1|Baseline|With Endoguide|Colonoscopy completed with endoguide
624853|NCT01055782|P2|Participant Flow|Without Endoguide|Colonoscopy completed without endoguide
624854|NCT01055782|P1|Participant Flow|With Endoguide|Colonoscopy completed with endoguide
624855|NCT01055782|O2|Outcome|Without Endoguide|Colonoscopy completed without endoguide
624856|NCT01055782|O1|Outcome|With Endoguide|Colonoscopy completed with endoguide
624857|NCT01055782|O2|Outcome|Without Endoguide|Exams completed without endoguide. Success rate/completion.
624858|NCT01055782|O1|Outcome|With Endoguide - Success Rate|Exams completed with endoguide. Success rate/completion.
624859|NCT01055782|E2|Reported Event|Without Endoguide|Colonoscopy completed without endoguide
624860|NCT01055782|E1|Reported Event|With Endoguide|Colonoscopy completed with endoguide
624861|NCT01055834|B3|Baseline|Total|Total of all reporting groups
624862|NCT01055834|B2|Baseline|Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab|"Participants received Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone one 3 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II.
After Period II there was at least a 5 day washout period. Certain participants from Group B only proceeded to Period III where they received Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast for 3 days. At least a 5 day period passed before post treatment examinations."
624863|NCT01055834|B1|Baseline|Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs|Participants received Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II. At least a 5 day period passed before post treatment examinations.
624864|NCT01055834|P2|Participant Flow|Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab|"Participants received a single dose of Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone one 3 mg tablet with water in the morning after fasting for 10 or more hours in Period II.
After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations."
624865|NCT01055834|P1|Participant Flow|Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs|Participants received a single dose of Eszopiclone one 3 mg tablet administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in Period II. At least a 5 day period passed before post treatment examinations.
624866|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group B Period III:
After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.
Except for the food and drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the food and drink at breakfast and the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
624867|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group B Period III:
After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.
Except for the food and drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the food and drink at breakfast and the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
624868|NCT01055834|O2|Outcome|Eszopiclone Three 1 mg Tablets|"Group A Period II, Group B Period I:
Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 10 or more hours.
Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
624869|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group A Period I, Group B Period II:
Eszopiclone one 3 mg tablet administered orally as a single administration with water in the morning after fasting for 10 or more hours.
Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
624902|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624903|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
625043|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
624870|NCT01055834|O2|Outcome|Eszopiclone Three 1 mg Tablets|"Group A Period II, Group B Period I:
Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 10 or more hours.
Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
624871|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group A Period I, Group B Period II:
Eszopiclone one 3 mg tablet administered orally as a single administration with water in the morning after fasting for 10 or more hours.
Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
624872|NCT01055834|E4|Reported Event|Eszopiclone One 3 mg Tablet (Fasted)|After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fasted conditions.
624873|NCT01055834|E3|Reported Event|Eszopiclone One 3 mg Tablet (Fed)|After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fed conditions.
624874|NCT01055834|E2|Reported Event|Eszopiclone Three 1 mg Tablets|Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II).
624875|NCT01055834|E1|Reported Event|Eszopiclone One 3 mg Tablet|Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II).
624876|NCT01055886|B3|Baseline|Total|Total of all reporting groups
624877|NCT01055886|B2|Baseline|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6
placebo patch: placebo patch used from weeks 4-6"
624878|NCT01055886|B1|Baseline|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6
nicotine patch: Nicotine patch, 7-21 mg."
624879|NCT01055886|P2|Participant Flow|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6
placebo patch: placebo patch used from weeks 4-6"
624880|NCT01055886|P1|Participant Flow|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6
nicotine patch: Nicotine patch, 7-21 mg."
624881|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6
placebo patch: placebo patch used from weeks 4-6"
624882|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6
nicotine patch: Nicotine patch, 7-21 mg."
624883|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6
placebo patch: placebo patch used from weeks 4-6"
624884|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6
nicotine patch: Nicotine patch, 7-21 mg."
624885|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6
placebo patch: placebo patch used from weeks 4-6"
624886|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6
nicotine patch: Nicotine patch, 7-21 mg."
624887|NCT01055886|E2|Reported Event|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6
placebo patch: placebo patch used from weeks 4-6"
624888|NCT01055886|E1|Reported Event|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6
nicotine patch: Nicotine patch, 7-21 mg."
624889|NCT01056107|B5|Baseline|Total|Total of all reporting groups
625016|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
624890|NCT01056107|B4|Baseline|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624891|NCT01056107|B3|Baseline|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624892|NCT01056107|B2|Baseline|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624893|NCT01056107|B1|Baseline|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624894|NCT01056107|P4|Participant Flow|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624895|NCT01056107|P3|Participant Flow|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624896|NCT01056107|P2|Participant Flow|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624897|NCT01056107|P1|Participant Flow|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624898|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624899|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624900|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624901|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
625099|NCT01056380|O2|Outcome|Placebo|Placebo : Tablet, twice daily with food for 5 days
624904|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624905|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624906|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624907|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624908|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624909|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624910|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624911|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624912|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624913|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624914|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624915|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624916|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624917|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624918|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624919|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624920|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624921|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624922|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624923|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624924|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624925|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
625017|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
624926|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624927|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624928|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624929|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624930|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624931|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624932|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624933|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624934|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624935|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624936|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624937|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624938|NCT01056107|E4|Reported Event|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
627984|NCT01059760|O2|Outcome|Change While Fasting|
624939|NCT01056107|E3|Reported Event|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624940|NCT01056107|E2|Reported Event|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624941|NCT01056107|E1|Reported Event|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
624942|NCT01056198|B3|Baseline|Total|Total of all reporting groups
624943|NCT01056198|B2|Baseline|Control|Daily gauze and optional sharp debridement
624944|NCT01056198|B1|Baseline|Santyl|2 mm Santyl once daily (QD)
624945|NCT01056198|P2|Participant Flow|Control|Daily gauze and optional sharp debridement
624946|NCT01056198|P1|Participant Flow|Santyl|2 mm Santyl once daily (QD)
624947|NCT01056198|O1|Outcome|Control|Daily gauze and optional sharp debridement
624948|NCT01056198|O1|Outcome|Santyl|2 mm Santyl QD
624949|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
624950|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
624951|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
624952|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
624953|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
624954|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
624955|NCT01056198|E2|Reported Event|Control|Daily gauze and optional sharp debridement
624956|NCT01056198|E1|Reported Event|Santyl|2 mm Santyl once daily (QD)
624957|NCT01056263|B1|Baseline|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
624958|NCT01056263|P1|Participant Flow|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
624959|NCT01056263|O1|Outcome|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
624960|NCT01056263|E1|Reported Event|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
624961|NCT01056276|B3|Baseline|Total|Total of all reporting groups
624962|NCT01056276|B2|Baseline|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.
Treatment:
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16
Maintenance:
Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
625018|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625019|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
624963|NCT01056276|B1|Baseline|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
624964|NCT01056276|P2|Participant Flow|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.
Treatment:
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16
Maintenance:
Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
624965|NCT01056276|P1|Participant Flow|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
624966|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.
Treatment:
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16
Maintenance:
Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
624967|NCT01056276|O1|Outcome|Originl BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
624985|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
624968|NCT01056276|O2|Outcome|BBD Treatment|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.
Treatment:
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16
Maintenance:
Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
624969|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. No maintenance therapy.
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
624970|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.
Treatment:
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16
Maintenance:
Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
624971|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
624972|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.
Treatment:
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16
Maintenance:
Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
624973|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
624974|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16
Maintenance:
Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
625020|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625021|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625022|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
627614|NCT01059565|B3|Baseline|Total|Total of all reporting groups
624975|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. No maintenance therapy.
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
624976|NCT01056276|E2|Reported Event|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.
Treatment:
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16
Maintenance:
Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
624977|NCT01056276|E1|Reported Event|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.
Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
624978|NCT01056289|B1|Baseline|Entire Study Population|24 Week Open-label phase DVS SR 50 mg PO QD followed by 4 Week Double-blind phase: DVS SR 50 mg (reference group), DVS SR 25 mg (taper group), or Placebo (abrupt-discontinuation group).
624979|NCT01056289|P4|Participant Flow|Placebo (Double-blind Phase)|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
624980|NCT01056289|P3|Participant Flow|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
624981|NCT01056289|P2|Participant Flow|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
624982|NCT01056289|P1|Participant Flow|DVS SR 50 mg (Open-label Phase)|Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 24 Weeks.
624983|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
624984|NCT01056289|O2|Outcome|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
627985|NCT01059760|O1|Outcome|Baseline Value|
624986|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
624987|NCT01056289|O2|Outcome|DVS SR 25 mg|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
624988|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
624989|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
624990|NCT01056289|O2|Outcome|DVS SR 25 mg|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
624991|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
624992|NCT01056289|E4|Reported Event|Placebo (Double-blind Phase)|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
624993|NCT01056289|E3|Reported Event|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
624994|NCT01056289|E2|Reported Event|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
624995|NCT01056289|E1|Reported Event|DVS SR 50 mg (Open-label Phase)|DVS SR 50 mg PO QD for 24 Weeks.
624996|NCT01056315|B3|Baseline|Total|Total of all reporting groups
624997|NCT01056315|B2|Baseline|Placebo|
624998|NCT01056315|B1|Baseline|GRT3983Y|
624999|NCT01056315|P2|Participant Flow|Placebo|
625000|NCT01056315|P1|Participant Flow|GRT3983Y|
625001|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625002|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625003|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625004|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625005|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625006|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625007|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625008|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625009|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625010|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625011|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625012|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625013|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625014|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625015|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625023|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625024|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625025|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625026|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625027|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625028|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625029|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
625030|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
625031|NCT01056315|E2|Reported Event|Placebo|
625032|NCT01056315|E1|Reported Event|GRT3983Y|
625033|NCT01056328|B3|Baseline|Total|Total of all reporting groups
625034|NCT01056328|B2|Baseline|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
625035|NCT01056328|B1|Baseline|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
625036|NCT01056328|P2|Participant Flow|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
625037|NCT01056328|P1|Participant Flow|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
625038|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
625039|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
625040|NCT01056328|O2|Outcome|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
625041|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
625042|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
627986|NCT01059760|O3|Outcome|Change When Fed|
625044|NCT01056328|O2|Outcome|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated Radio Frequency (RF) Ablation System: Irrigated ablation catheter
625045|NCT01056328|O1|Outcome|St Jude Medical (SJM) Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
625046|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
625047|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
625048|NCT01056328|E2|Reported Event|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
625049|NCT01056328|E1|Reported Event|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
625050|NCT01056341|B6|Baseline|Total|Total of all reporting groups
625051|NCT01056341|B5|Baseline|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
625052|NCT01056341|B4|Baseline|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
625053|NCT01056341|B3|Baseline|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
625054|NCT01056341|B2|Baseline|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
625055|NCT01056341|B1|Baseline|Placebo|Placebo: Treatment with placebo for 6 months
625056|NCT01056341|P5|Participant Flow|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
625057|NCT01056341|P4|Participant Flow|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
625058|NCT01056341|P3|Participant Flow|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
625059|NCT01056341|P2|Participant Flow|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
625060|NCT01056341|P1|Participant Flow|Placebo|Placebo: Treatment with placebo for 6 months
625061|NCT01056341|O2|Outcome|Propranolol 3mg/kg/d 6 Months|Propranolol 3 mg/kg/day for 6 months
625062|NCT01056341|O1|Outcome|Placebo|Placebo: Treatment with placebo for 6 months
625063|NCT01056341|O5|Outcome|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
625064|NCT01056341|O4|Outcome|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
625065|NCT01056341|O3|Outcome|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
625066|NCT01056341|O2|Outcome|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
625067|NCT01056341|O1|Outcome|Placebo|Placebo: Treatment with placebo for 6 months
625068|NCT01056341|E10|Reported Event|W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set|72-week follow-up period without study treatment administration
625069|NCT01056341|E9|Reported Event|W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set|72-week follow-up period without study treatment administration
625070|NCT01056341|E8|Reported Event|W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set|72-week follow-up period without study treatment administration
625071|NCT01056341|E7|Reported Event|W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set|72-week follow-up period without study treatment administration
625072|NCT01056341|E6|Reported Event|W72-follow-up Period of ex Placebo Group-safety Set|72-week follow-up period without study treatment administration
625073|NCT01056341|E5|Reported Event|W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 6 Months|Propranolol hydrochloride oral solution 3mg/kg/day for 6 months
625074|NCT01056341|E4|Reported Event|W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 3 Months|Propranolol hydrochloride oral solution 3mg/kg/day for 3 months, then placebo for 3 months
625075|NCT01056341|E3|Reported Event|W24-treatment Period-safety Set-Propranolol 1 mg/kg/d 6 Months|Propranolol hydrochloride oral solution 1mg/kg/day for 6 months
625076|NCT01056341|E2|Reported Event|W24-treatment Period-safety Set-Propranolol 1mg/kg/d 3 Months|Propranolol hydrochloride oral solution 1mg/kg/day for 3 months, then placebo for 3 months
625077|NCT01056341|E1|Reported Event|W24-treatment Period-safety Set-Placebo|Placebo: Treatment with placebo for 6 months
625078|NCT01056380|B3|Baseline|Total|Total of all reporting groups
625079|NCT01056380|B2|Baseline|Placebo|Placebo : Tablet, twice daily with food for 5 days
625080|NCT01056380|B1|Baseline|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
625081|NCT01056380|P2|Participant Flow|Placebo|Placebo : Tablet, twice daily with food for 5 days
625082|NCT01056380|P1|Participant Flow|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
625083|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
625084|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
625085|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
625086|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
625087|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
625088|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
625089|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
625090|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
625091|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
625092|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
625093|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
625094|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
625095|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
625096|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
625097|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
625098|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
625102|NCT01056380|E1|Reported Event|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
625103|NCT01056484|B3|Baseline|Total|Total of all reporting groups
625104|NCT01056484|B2|Baseline|Wait-list Control|"Standard of Care therapy only
Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
625105|NCT01056484|B1|Baseline|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy
Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
625106|NCT01056484|P2|Participant Flow|Wait-list Control|"Standard of Care therapy only
Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
625107|NCT01056484|P1|Participant Flow|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy
Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
625108|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only
Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
625109|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy
Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
625110|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only
Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
625470|NCT01057888|P2|Participant Flow|Controls|"Controls
Received standard of care provided by practice"
625111|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy
Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
625112|NCT01056484|O1|Outcome|Meditation|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention
625113|NCT01056484|O1|Outcome|Meditation|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention
625114|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only
Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
625115|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy
Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
625116|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only
Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
625117|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy
Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
625118|NCT01056484|E2|Reported Event|Wait-list Control|"Standard of Care therapy only
Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
625119|NCT01056484|E1|Reported Event|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy
Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
625120|NCT01056510|B3|Baseline|Total|Total of all reporting groups
625121|NCT01056510|B2|Baseline|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625122|NCT01056510|B1|Baseline|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625123|NCT01056510|P2|Participant Flow|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally (PO) at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until complete response (CR) was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625220|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625471|NCT01057888|P1|Participant Flow|Autodialer|"Autodialer reminder/recall
Autodialer : Autodialer telephone calls"
632612|NCT01085045|E3|Reported Event|GP MDI 36 μg|GP MDI 36 μg (PT001)
625124|NCT01056510|P1|Participant Flow|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received intravenous (IV) rituximab 375 milligrams per square meter (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced progressive disease (PD).
625125|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625126|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625127|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625128|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625129|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
627987|NCT01059760|O2|Outcome|Change While Fasting|
625130|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625131|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625132|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625133|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625134|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625135|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625136|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625137|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625221|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625138|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625139|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625140|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625141|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625142|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625143|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625180|NCT01056523|E1|Reported Event|Ribavirin-Cytarabine|"Ribavirin: Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID
Cytarabine arabinoside: Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle.
Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts."
625197|NCT01056653|B3|Baseline|Group C Yellow|"Comparison Group (information only)
Comparison Group: One home visit, information only"
625144|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625145|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625146|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625147|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625148|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625149|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625150|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625151|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625152|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625153|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625154|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625155|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625156|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625157|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625181|NCT01056601|B1|Baseline|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
625198|NCT01056653|B2|Baseline|Group B Purple|"Four home visits
High Dose: Four home visits"
625158|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625159|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625160|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625161|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625162|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625163|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625164|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625165|NCT01056510|E2|Reported Event|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625166|NCT01056510|E1|Reported Event|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
625167|NCT01056523|B1|Baseline|Ribavirin and Cytarabine|Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID Drug: Cytarabine arabinoside Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle. Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts.
625168|NCT01056523|P7|Participant Flow|Dose Level 7|Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
625169|NCT01056523|P6|Participant Flow|Dose Level 6|Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
625170|NCT01056523|P5|Participant Flow|Dose Level 5|Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
625171|NCT01056523|P4|Participant Flow|Dose Level 4|Ribavirin 2200 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
625172|NCT01056523|P3|Participant Flow|Dose Level 3|Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
625173|NCT01056523|P2|Participant Flow|Dose Level 2|Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
625174|NCT01056523|P1|Participant Flow|Dose Level 1|Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
625175|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
625176|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
625177|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
625178|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
625179|NCT01056523|O1|Outcome|Ribavirin-Cytarabine|"Ribavirin: Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID
Cytarabine arabinoside: Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle.
Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts."
625196|NCT01056653|B4|Baseline|Total|Total of all reporting groups
625182|NCT01056601|P1|Participant Flow|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
625183|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
625184|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
625185|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
625186|NCT01056601|E1|Reported Event|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
625187|NCT01056640|B3|Baseline|Total|Total of all reporting groups
625188|NCT01056640|B2|Baseline|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.
Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
625189|NCT01056640|B1|Baseline|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.
Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
625222|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625472|NCT01057888|O3|Outcome|Control|Received no reminders from the managed care organization.
627368|NCT01069939|P1|Participant Flow|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
625190|NCT01056640|P2|Participant Flow|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.
Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
625191|NCT01056640|P1|Participant Flow|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.
Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
625192|NCT01056640|O2|Outcome|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.
Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
625193|NCT01056640|O1|Outcome|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.
Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
625194|NCT01056640|E2|Reported Event|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.
Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
625195|NCT01056640|E1|Reported Event|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.
Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
625200|NCT01056653|P3|Participant Flow|Group C Yellow|"Comparison Group (information only)
Comparison Group: One home visit, information only (at 4 months of age)"
625201|NCT01056653|P2|Participant Flow|Group B Purple|"Four home visits
High Dose: Four home visits (at 4, 5, 6, and 7 months of age)"
625202|NCT01056653|P1|Participant Flow|Group A Teal|"Two intervention home visits
Standard Dose: Two home visits (at 4 and 6 months of age)"
625203|NCT01056653|O3|Outcome|Group C Yellow|"Comparison Group (information only)
Comparison Group: One home visit, information only"
625204|NCT01056653|O2|Outcome|Group B Purple|"Four home visits
High Dose: Four home visits"
625205|NCT01056653|O1|Outcome|Group A Teal|"Two intervention home visits
Standard Dose: Two home visits"
625206|NCT01056653|O3|Outcome|Group C Yellow|"Comparison Group (information only)
Comparison Group: One home visit, information only"
625207|NCT01056653|O2|Outcome|Group B Purple|"Four intervention home visits
High Dose: Four home visits"
625208|NCT01056653|O1|Outcome|Group A Teal|"Two intervention home visits
Standard Dose: Two home visits"
625209|NCT01056653|O3|Outcome|Group C Yellow|"Comparison Group (information only)
Comparison Group: One home visit, information only"
625210|NCT01056653|O2|Outcome|Group B Purple|"Four intervention home visits
High Dose: Four home visits"
625211|NCT01056653|O1|Outcome|Group A Teal|"Two intervention home visits
Standard Dose: Two home visits"
625212|NCT01056653|E3|Reported Event|Group C Yellow|"Comparison Group (information only)
Comparison Group: One home visit, information only"
625213|NCT01056653|E2|Reported Event|Group B Purple|"Four home visits
High Dose: Four home visits"
625214|NCT01056653|E1|Reported Event|Group A Teal|"Two intervention home visits
Standard Dose: Two home visits"
625215|NCT01056718|B1|Baseline|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625216|NCT01056718|P1|Participant Flow|Nebivolol Treatment|10 week open label nebivolol treatment.
625217|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625218|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625219|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625223|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625224|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625225|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625226|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625227|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625228|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625229|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625230|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625231|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625232|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625233|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625234|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625235|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625236|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625237|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625238|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625239|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625240|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625241|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625242|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625243|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625244|NCT01056718|E1|Reported Event|Starting on 5 mg of Nebivolol Then Titrated|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
625245|NCT01056822|B3|Baseline|Total|Total of all reporting groups
625246|NCT01056822|B2|Baseline|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625247|NCT01056822|B1|Baseline|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625248|NCT01056822|P2|Participant Flow|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625249|NCT01056822|P1|Participant Flow|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625250|NCT01056822|O1|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625317|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Treatment (Lenalidomide)|"Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625251|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625252|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625253|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625254|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625255|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625256|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625257|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625258|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625307|NCT01057121|B1|Baseline|Phase I - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
627369|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
625259|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625260|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625261|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625262|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625263|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625264|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625318|NCT01057121|O2|Outcome|Phase I - 15 mg/Dah Treatment (Lenalidomide)|"Patients receive 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625265|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625266|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625267|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625268|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625269|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625270|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625271|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625272|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625273|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625274|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625275|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625276|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625277|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625278|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625338|NCT01057121|E2|Reported Event|Phase I: 15 mg/Day Lenalidomide|"Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625279|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625280|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625281|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625282|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625283|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625284|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625285|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625286|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625287|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625288|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625289|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625290|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625291|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625292|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625339|NCT01057121|E1|Reported Event|Phase I: 10 mg/Day Lenalidomide|"Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625293|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
625294|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
625295|NCT01056822|E2|Reported Event|Micofenolato Mofetilo|Micofenolato mofetilo
625296|NCT01056822|E1|Reported Event|Micofenolato Sodium|Micofenolato sodium
625297|NCT01056913|B1|Baseline|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device
follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
625298|NCT01056913|P1|Participant Flow|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device
follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
625299|NCT01056913|O1|Outcome|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device
follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
625300|NCT01056913|E1|Reported Event|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device
follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
625301|NCT01057017|B1|Baseline|Intervention|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.
Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
625302|NCT01057017|P1|Participant Flow|Panitumumab and Bevacizumab|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.
Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
625303|NCT01057017|O1|Outcome|Panitumumab and Bevacizumab|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.
Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
625304|NCT01057017|E1|Reported Event|Intervention|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.
Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
625305|NCT01057121|B3|Baseline|Total|Total of all reporting groups
625306|NCT01057121|B2|Baseline|Phase II - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
626123|NCT01061333|E3|Reported Event|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
625308|NCT01057121|P5|Participant Flow|Phase II: Treatment (Lenalidomide), 25 mg/Day|Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
625309|NCT01057121|P4|Participant Flow|Phase I: Treatment (Lenalidomide), 25 mg/Day|Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
625310|NCT01057121|P3|Participant Flow|Phase I, Treatment Ienalidomide), 20 mg/Day|Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
625311|NCT01057121|P2|Participant Flow|Phase I: Treatment (Lenalidomide), 15 mg/Day|Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
625312|NCT01057121|P1|Participant Flow|Phase I: Treatment (Lenalidomide) , 10 mg/Day|Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
625313|NCT01057121|O2|Outcome|Phase II - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625314|NCT01057121|O1|Outcome|Phase I - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625315|NCT01057121|O5|Outcome|Phase II: 25 m/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625316|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625340|NCT01057225|B1|Baseline|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
625319|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Treatment (Lenalidomide)|"Patients receive 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625320|NCT01057121|O5|Outcome|Phase II: 25 m/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625321|NCT01057121|O4|Outcome|Phase I: Treatment (Lenalidomide), 25 mg/Day|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625322|NCT01057121|O3|Outcome|Phase I - 20 mg/Day Treatment (Lenalidomide)|"Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625323|NCT01057121|O2|Outcome|Phase I - 15 mg/Dah Treatment (Lenalidomide)|"Patients receive 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625324|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Treatment (Lenalidomide)|"Patients receive 10 mg/day of lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625325|NCT01057121|O5|Outcome|Phase II: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625326|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625327|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Lenalidomide|"Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625328|NCT01057121|O2|Outcome|Phase I - 15 mg/Day Lenalidomide|"Patients received lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625329|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Lenalidomide|"Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
634812|NCT01080391|B3|Baseline|Total|Total of all reporting groups
625330|NCT01057121|O5|Outcome|Phase II: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625331|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625332|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Lenalidomide|"Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625333|NCT01057121|O2|Outcome|Phase I - 15 mg/Day (Lenalidomide)|"Patients received 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625334|NCT01057121|O1|Outcome|Phase I - 10 mg/Day (Lenalidomide)|"Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625335|NCT01057121|O1|Outcome|Phase I - Treatment (Lenalidomide)|"Phase I: Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles This arm includes patients treated at the 10 mg/day dose (N=3), 15 mg/day dose (N=3), 20 mg/day dose (N=3) and 25 mg/day dose (N=6)"
625336|NCT01057121|E4|Reported Event|Phase I and II: 25 mg/Day Lenalidomide|"Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625337|NCT01057121|E3|Reported Event|Phase I: 20 mg/Day Lenalidomide|"Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
625341|NCT01057225|P6|Participant Flow|Phase II: Dose Level 1|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625342|NCT01057225|P5|Participant Flow|Phase II: Dose Level 0|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625343|NCT01057225|P4|Participant Flow|Phase I: Dose Level 2|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625344|NCT01057225|P3|Participant Flow|Phase I: Dose Level 1|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625345|NCT01057225|P2|Participant Flow|Phase I: Dose Level 0|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625346|NCT01057225|P1|Participant Flow|Phase I: Dose Level -1|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625347|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
625348|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
625349|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
625350|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
625351|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
625352|NCT01057225|O4|Outcome|Dose Level 2|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625353|NCT01057225|O3|Outcome|Dose Level 1|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625354|NCT01057225|O2|Outcome|Dose Level 0|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625355|NCT01057225|O1|Outcome|Dose Level -1|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;
Oral 40 mg dexamethasone on days 1, 8, 15, and 22;
Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625356|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
625357|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
625358|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
625359|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
625360|NCT01057225|O4|Outcome|Phase I: Dose Level 2|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625361|NCT01057225|O3|Outcome|Phase I: Dose Level 1|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625362|NCT01057225|O2|Outcome|Phase I: Dose Level 0|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
625363|NCT01057225|O1|Outcome|Phase I: Dose Level -1|"Patients receive:
Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.
Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
627988|NCT01059760|O1|Outcome|Baseline Value|
625364|NCT01057225|E1|Reported Event|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
625365|NCT01057251|B3|Baseline|Total|Total of all reporting groups
625366|NCT01057251|B2|Baseline|Placebo|Dose-matched placebo, once daily oral administration
625367|NCT01057251|B1|Baseline|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
625368|NCT01057251|P2|Participant Flow|Placebo|Dose-matched placebo, once daily oral administration
625369|NCT01057251|P1|Participant Flow|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
625370|NCT01057251|O2|Outcome|Placebo|Dose-matched placebo, once daily oral administration
625371|NCT01057251|O1|Outcome|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
625372|NCT01057251|O2|Outcome|Placebo|Dose-matched placebo, once daily oral administration
625373|NCT01057251|O1|Outcome|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
625374|NCT01057251|E2|Reported Event|Placebo|Dose-matched placebo, once daily oral administration
625375|NCT01057251|E1|Reported Event|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
625376|NCT01057277|B1|Baseline|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47
RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
625377|NCT01057277|P1|Participant Flow|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47
RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
625378|NCT01057277|O1|Outcome|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47
RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
625379|NCT01057277|E1|Reported Event|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47
RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
625380|NCT01057394|B1|Baseline|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
625381|NCT01057394|P2|Participant Flow|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
625382|NCT01057394|P1|Participant Flow|Radiofrequency Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
625383|NCT01057394|O1|Outcome|Number of Chronically Isolated Pulmonary Veins|
625384|NCT01057394|E1|Reported Event|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
625385|NCT01057433|B1|Baseline|All Subjects|
625386|NCT01057433|P1|Participant Flow|All Subjects|
625387|NCT01057433|O1|Outcome|All Subjects|
625388|NCT01057433|E1|Reported Event|All Subjects|
625421|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625422|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
635320|NCT01082575|E1|Reported Event|Major Surgery|Post Operative patients
625389|NCT01057589|B1|Baseline|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
625390|NCT01057589|P1|Participant Flow|Pemetrexed + Cisplatin + Cetuximab|"Pemetrexed 500 milligram per meter squared (mg/m^2) administered by intravenous (IV) infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles.
At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months.
Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements."
625391|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
625392|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
625408|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625409|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625496|NCT01058005|P1|Participant Flow|Natalizumab|300 mg intravenous injection every 4 weeks
625393|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
625394|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
625395|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
625396|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
625423|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625397|NCT01057589|E1|Reported Event|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
625398|NCT01057693|B1|Baseline|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625399|NCT01057693|P3|Participant Flow|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625400|NCT01057693|P2|Participant Flow|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625401|NCT01057693|P1|Participant Flow|Pregabalin SB|Participants who were inadequately controlled on their current diabetic peripheral neuropathy (DPN) treatment were switched to single-blind (SB) pregabalin capsules at a starting dose of 150 milligram per day (mg/day) and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced greater than or equal to (>=) 30 percent (%) pain reduction from baseline to Week 6 were eligible for double-blind (DB) treatment phase.
625402|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625403|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625404|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625405|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625406|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625407|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625489|NCT01057901|E1|Reported Event|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime
Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
625410|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625411|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625412|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625413|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625414|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625415|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625416|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625417|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625418|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625419|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625420|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625424|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625425|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625426|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625427|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625428|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625429|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625430|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625431|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625432|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625433|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625490|NCT01058005|B4|Baseline|Total|Total of all reporting groups
625491|NCT01058005|B3|Baseline|Glatiramer Acetate|20 mg subcutaneous injection once daily
625492|NCT01058005|B2|Baseline|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
625434|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625435|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625436|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625437|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625438|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625439|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625440|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625441|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625442|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625443|NCT01057693|E3|Reported Event|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
625444|NCT01057693|E2|Reported Event|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
625445|NCT01057693|E1|Reported Event|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
625446|NCT01057810|B3|Baseline|Total|Total of all reporting groups
625447|NCT01057810|B2|Baseline|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625469|NCT01057888|P3|Participant Flow|Letters|"Mailed reminder letters
Letters : Mailed reminder letters"
625448|NCT01057810|B1|Baseline|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625449|NCT01057810|P2|Participant Flow|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625450|NCT01057810|P1|Participant Flow|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625451|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625452|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625453|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625454|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625455|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625493|NCT01058005|B1|Baseline|Natalizumab|300 mg intravenous injection every 4 weeks
625494|NCT01058005|P3|Participant Flow|Glatiramer Acetate|20 mg subcutaneous injection once daily
625456|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625457|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625458|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625459|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625460|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625461|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625462|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625463|NCT01057810|E2|Reported Event|10 MG/KG IPILIMUMAB|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625464|NCT01057810|E1|Reported Event|PLACEBO|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
625465|NCT01057888|B4|Baseline|Total|Total of all reporting groups
625466|NCT01057888|B3|Baseline|Letters|"Mailed reminder letters
Letters : Mailed reminder letters"
625467|NCT01057888|B2|Baseline|Controls|"Controls
Received standard of care provided by practice"
625468|NCT01057888|B1|Baseline|Autodialer|"Autodialer reminder/recall
Autodialer : Autodialer telephone calls"
625473|NCT01057888|O2|Outcome|Telephone Reminder|Received telephone reminders (through an autodialer)from the managed-care organization for recommended vaccinations
625474|NCT01057888|O1|Outcome|Letter Reminder|Received mailed reminders from the managed-care organization for recommended vaccinations
625475|NCT01057888|O3|Outcome|Control|Received no reminders from the managed care organization.
625476|NCT01057888|O2|Outcome|Telephone Reminder|Received telephone reminders (through an autodialer)from the managed-care organization for recommended vaccinations
625477|NCT01057888|O1|Outcome|Letter Reminder|Received mailed reminders from the managed-care organization for recommended vaccinations
625478|NCT01057888|E1|Reported Event|Mailed Reminders and Letter Reminders|
625479|NCT01057901|B3|Baseline|Total|Total of all reporting groups
625480|NCT01057901|B2|Baseline|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.
Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
625481|NCT01057901|B1|Baseline|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime
Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
625482|NCT01057901|P2|Participant Flow|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.
Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
625483|NCT01057901|P1|Participant Flow|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime
Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
625484|NCT01057901|O2|Outcome|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.
Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
625485|NCT01057901|O1|Outcome|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime
Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
625486|NCT01057901|O2|Outcome|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.
Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
625487|NCT01057901|O1|Outcome|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime
Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
625488|NCT01057901|E2|Reported Event|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.
Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
625495|NCT01058005|P2|Participant Flow|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
625497|NCT01058005|O3|Outcome|Glatiramer Acetate|20 mg subcutaneous injection once daily
625498|NCT01058005|O2|Outcome|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
625499|NCT01058005|O1|Outcome|Natalizumab|300 mg intravenous injection every 4 weeks
625500|NCT01058005|E3|Reported Event|Glatiramer Acetate|20 mg subcutaneous injection once daily
625501|NCT01058005|E2|Reported Event|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
625502|NCT01058005|E1|Reported Event|Natalizumab|300 mg intravenous injection every 4 weeks
625503|NCT01058070|B1|Baseline|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
625504|NCT01058070|P1|Participant Flow|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
625505|NCT01058070|O1|Outcome|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
625506|NCT01058070|O1|Outcome|LINX Study Subjects|Subjects implanted with LINX device
625507|NCT01058070|E1|Reported Event|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
625508|NCT01058096|B3|Baseline|Total|Total of all reporting groups
625509|NCT01058096|B2|Baseline|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
625510|NCT01058096|B1|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
625511|NCT01058096|P2|Participant Flow|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
625512|NCT01058096|P1|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
625513|NCT01058096|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
625514|NCT01058096|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
625515|NCT01058096|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
625516|NCT01058096|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
625517|NCT01058096|E2|Reported Event|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
625518|NCT01058096|E1|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
625519|NCT01058265|B3|Baseline|Total|Total of all reporting groups
625520|NCT01058265|B2|Baseline|Standard|Standard general medical evaluation.
625521|NCT01058265|B1|Baseline|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
625522|NCT01058265|P2|Participant Flow|Standard|Standard general medical evaluation.
625563|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625564|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
626124|NCT01061333|E2|Reported Event|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
625523|NCT01058265|P1|Participant Flow|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
625524|NCT01058265|O2|Outcome|Standard|Standard general medical evaluation.
625525|NCT01058265|O1|Outcome|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
625526|NCT01058265|O2|Outcome|Standard|Standard general medical evaluation.
625527|NCT01058265|O1|Outcome|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
625528|NCT01058265|E2|Reported Event|Standard|Standard general medical evaluation.
625529|NCT01058265|E1|Reported Event|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
625530|NCT01058304|B3|Baseline|Total|Total of all reporting groups
625531|NCT01058304|B2|Baseline|Individual Physical Therapy for Knee OA|"Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
625532|NCT01058304|B1|Baseline|Group Physical Therapy for Knee OA|"Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
625533|NCT01058304|P2|Participant Flow|Individual Physical Therapy for Knee OA|"Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
625534|NCT01058304|P1|Participant Flow|Group Physical Therapy for Knee OA|"Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
625535|NCT01058304|O2|Outcome|Arm 2|"Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
625536|NCT01058304|O1|Outcome|Arm 1|"Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
625537|NCT01058304|O2|Outcome|Arm 2|"Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
626259|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
625538|NCT01058304|O1|Outcome|Arm 1|"Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
625539|NCT01058304|E2|Reported Event|Arm 2|"Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
625540|NCT01058304|E1|Reported Event|Arm 1|"Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
625541|NCT01058356|B1|Baseline|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid
(1 capsule twice a day for 14 days)"
625542|NCT01058356|P1|Participant Flow|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid
(1 capsule twice a day for 14 days)"
625543|NCT01058356|O1|Outcome|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid
(1 capsule twice a day for 14 days)"
625544|NCT01058356|O1|Outcome|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid
(1 capsule twice a day for 14 days)"
625545|NCT01058356|E1|Reported Event|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid
(1 capsule twice a day for 14 days)"
625547|NCT01058421|B2|Baseline|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625548|NCT01058421|B1|Baseline|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
625549|NCT01058421|P2|Participant Flow|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625550|NCT01058421|P1|Participant Flow|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
625551|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625552|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
625553|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625554|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
625555|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625556|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
625557|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625558|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
625559|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625560|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
625561|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625562|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
626260|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
625565|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625566|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
625567|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625568|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
625569|NCT01058421|E2|Reported Event|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
625570|NCT01058421|E1|Reported Event|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
625571|NCT01047241|B1|Baseline|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
625572|NCT01047241|P1|Participant Flow|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
625573|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
625574|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
625575|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
625576|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing sufentanil/ketamine. Dose sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
625577|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
625578|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose
625579|NCT01047241|E1|Reported Event|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
625581|NCT01047293|P4|Participant Flow|ARM 4 10mg RAD001 QD - Phase II|Patients received 10 mg RAD001 with FOLFOX and bevacizumab. - Patient in the Dose Expansion Cohort not Dose Escalation
625582|NCT01047293|P3|Participant Flow|ARM 3 10mg RAD001 QD|Patients received 10mg RAD001 QD with FOLFOX and bevacizumab.
625583|NCT01047293|P2|Participant Flow|ARM 2 5mg RAD001 QD|Patients received 5mg RAD001 QD with FOLFOX and bevacizumab.
625584|NCT01047293|P1|Participant Flow|ARM 1 RAD001 5 mg QOD|Patients received 5mg RAD001 with FOLFOX and bevacizumab.
625585|NCT01047293|O3|Outcome|ARM 3 10mg RAD001 QD|Patients received 10mg RAD001 QD with FOLFOX and bevacizumab.
625586|NCT01047293|O2|Outcome|ARM 2 5mg RAD001 QD|Patients received 5mg RAD001 QD with FOLFOX and bevacizumab.
625587|NCT01047293|O1|Outcome|ARM 1 RAD001 5 mg QOD|Patients received 5mg RAD001 with FOLFOX and bevacizumab.
625588|NCT01047293|O1|Outcome|All Patients|
625589|NCT01047293|E1|Reported Event|All Patients|All participants enrolled.
625590|NCT01047306|B3|Baseline|Total|Total of all reporting groups
625591|NCT01047306|B2|Baseline|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625592|NCT01047306|B1|Baseline|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625593|NCT01047306|P2|Participant Flow|Children ≥ 6 Years Old|Children ≥ 6 years of age with Sanfilippo Syndrome Type A (mucopolysaccharidosis type IIIA; MPS IIIA) who were untreated with any investigational products (drugs and/or devices).
625594|NCT01047306|P1|Participant Flow|Children < 6 Years Old|Children ≥1 to < 6 years of age with Sanfilippo Syndrome Type A (mucopolysaccharidosis type IIIA; MPS IIIA) who were untreated with any investigational products (drugs and/or devices).
625595|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625596|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625597|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625598|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625599|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625600|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625601|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625602|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625603|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625604|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625605|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625606|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625607|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625608|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625609|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625610|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625611|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625612|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625613|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625614|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625615|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625616|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625617|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625618|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625619|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625620|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625621|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625622|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
626227|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
625623|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625624|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625625|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625626|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625627|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625628|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625629|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625630|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625631|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625632|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625633|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625634|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625635|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625636|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625637|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625638|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625639|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625640|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625641|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625642|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625643|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625644|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625645|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625646|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625647|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625648|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625649|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625650|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625651|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625652|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625653|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625654|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625655|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625656|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625657|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625658|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625659|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625660|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625661|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625662|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625663|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625664|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625665|NCT01047306|E2|Reported Event|Children ≥ 6 Years|Patients ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625666|NCT01047306|E1|Reported Event|Children < 6 Years|Patients ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
625667|NCT01047332|B3|Baseline|Total|Total of all reporting groups
625668|NCT01047332|B2|Baseline|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
625669|NCT01047332|B1|Baseline|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
625670|NCT01047332|P2|Participant Flow|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
625671|NCT01047332|P1|Participant Flow|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
625672|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
625673|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
625674|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
625675|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
625676|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
625677|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
625678|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
625679|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
625680|NCT01047332|E2|Reported Event|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
625681|NCT01047332|E1|Reported Event|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
625682|NCT01047345|B3|Baseline|Total|Total of all reporting groups
625683|NCT01047345|B2|Baseline|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
625684|NCT01047345|B1|Baseline|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
625685|NCT01047345|P3|Participant Flow|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
625750|NCT01052831|E2|Reported Event|Placebo|Participants received the placebo treatment which looked identical to active study medication.
635321|NCT01082588|B3|Baseline|Total|Total of all reporting groups
625686|NCT01047345|P2|Participant Flow|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
625687|NCT01047345|P1|Participant Flow|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
625688|NCT01047345|O1|Outcome|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
625689|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
625690|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
625691|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
625692|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
625693|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
625694|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
625695|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
625696|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
625697|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
625726|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
625698|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
625699|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
625700|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
625701|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
625702|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
625703|NCT01047345|E3|Reported Event|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
625704|NCT01047345|E2|Reported Event|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
625705|NCT01047345|E1|Reported Event|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
625706|NCT01047358|B1|Baseline|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
625707|NCT01047358|P1|Participant Flow|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
625708|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
625749|NCT01052831|O1|Outcome|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
625709|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
625710|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
625711|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
625712|NCT01047358|E1|Reported Event|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
625713|NCT01047436|B3|Baseline|Total|Total of all reporting groups
625714|NCT01047436|B2|Baseline|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
625715|NCT01047436|B1|Baseline|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
625716|NCT01047436|P2|Participant Flow|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
625717|NCT01047436|P1|Participant Flow|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
625718|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
625719|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
625720|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
625721|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
625722|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
625723|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
625724|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
625725|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
627161|NCT01069120|P1|Participant Flow|Proellex®|25 or 50 mg capsules once per day
625727|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
625728|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
625729|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
625730|NCT01047436|E2|Reported Event|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
625731|NCT01047436|E1|Reported Event|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
625732|NCT01047475|B3|Baseline|Total|Total of all reporting groups
625733|NCT01047475|B2|Baseline|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo: 6# TID with meal"
625734|NCT01047475|B1|Baseline|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
MB-6: 6# TID with meal"
625735|NCT01047475|P2|Participant Flow|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo: 6# TID with meal"
625736|NCT01047475|P1|Participant Flow|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
MB-6: 6# TID with meal"
625737|NCT01047475|O2|Outcome|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo: 6# TID with meal"
625738|NCT01047475|O1|Outcome|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
MB-6: 6# TID with meal"
625739|NCT01047475|E2|Reported Event|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo: 6# TID with meal"
625740|NCT01047475|E1|Reported Event|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
MB-6: 6# TID with meal"
625741|NCT01052831|B3|Baseline|Total|Total of all reporting groups
625742|NCT01052831|B2|Baseline|Placebo|"Participants will receive placebo treatment
Placebo: 50-100 mg qd for 8 weeks"
625743|NCT01052831|B1|Baseline|Naltrexone|"Participants will receive Naltrexone
Naltrexone: 50-100 mg qd for 8 weeks"
625744|NCT01052831|P2|Participant Flow|Placebo|Participants received the placebo treatment which looked identical to active study medication.
625745|NCT01052831|P1|Participant Flow|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
625746|NCT01052831|O2|Outcome|Placebo|Participants received the placebo treatment which looked identical to active study medication.
625747|NCT01052831|O1|Outcome|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
625748|NCT01052831|O2|Outcome|Placebo|Participants received the placebo treatment which looked identical to active study medication.
626261|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
625751|NCT01052831|E1|Reported Event|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
625752|NCT01052844|B3|Baseline|Total|Total of all reporting groups
625753|NCT01052844|B2|Baseline|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Gabapentin 300mg:
Five and four days before chemotherapy (day -5 and day -4): 1x daily
Three and two days before chemotherapy (day -3 and day -2): 2x daily
One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
625754|NCT01052844|B1|Baseline|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Placebo:
Five and four days before chemotherapy (day -5 and day -4): 1x daily
Three and two days before chemotherapy (day -3 and day -2): 2x daily
One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
625755|NCT01052844|P2|Participant Flow|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Gabapentin 300mg:
Five and four days before chemotherapy (day -5 and day -4): 1x daily
Three and two days before chemotherapy (day -3 and day -2): 2x daily
One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
625756|NCT01052844|P1|Participant Flow|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Placebo:
Five and four days before chemotherapy (day -5 and day -4): 1x daily
Three and two days before chemotherapy (day -3 and day -2): 2x daily
One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
625757|NCT01052844|O2|Outcome|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Gabapentin 300mg:
Five and four days before chemotherapy (day -5 and day -4): 1x daily
Three and two days before chemotherapy (day -3 and day -2): 2x daily
One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
625758|NCT01052844|O1|Outcome|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Placebo:
Five and four days before chemotherapy (day -5 and day -4): 1x daily
Three and two days before chemotherapy (day -3 and day -2): 2x daily
One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
625759|NCT01052844|O2|Outcome|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Gabapentin 300mg:
Five and four days before chemotherapy (day -5 and day -4): 1x daily
Three and two days before chemotherapy (day -3 and day -2): 2x daily
One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
625859|NCT01058668|E1|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
625760|NCT01052844|O1|Outcome|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Placebo:
Five and four days before chemotherapy (day -5 and day -4): 1x daily
Three and two days before chemotherapy (day -3 and day -2): 2x daily
One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
625761|NCT01052844|E2|Reported Event|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Gabapentin 300mg:
Five and four days before chemotherapy (day -5 and day -4): 1x daily
Three and two days before chemotherapy (day -3 and day -2): 2x daily
One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
625762|NCT01052844|E1|Reported Event|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Placebo:
Five and four days before chemotherapy (day -5 and day -4): 1x daily
Three and two days before chemotherapy (day -3 and day -2): 2x daily
One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
625763|NCT01052948|B5|Baseline|Total|Total of all reporting groups
625764|NCT01052948|B4|Baseline|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
625765|NCT01052948|B3|Baseline|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
625766|NCT01052948|B2|Baseline|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
625767|NCT01052948|B1|Baseline|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
625768|NCT01052948|P4|Participant Flow|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
625769|NCT01052948|P3|Participant Flow|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
625770|NCT01052948|P2|Participant Flow|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
625771|NCT01052948|P1|Participant Flow|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
625772|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
625773|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
625774|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
625775|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
625776|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
625777|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
625778|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
625779|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
625780|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
625781|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
625782|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
625857|NCT01058668|E3|Reported Event|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
625783|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
625784|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
625785|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
625786|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
625787|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
625788|NCT01052948|E4|Reported Event|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
625789|NCT01052948|E3|Reported Event|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
625790|NCT01052948|E2|Reported Event|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
625791|NCT01052948|E1|Reported Event|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
625792|NCT01053000|B1|Baseline|All Study Participants|"Tazorac o.1% gel foer 1 week to the randomly chosen arm
20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
625793|NCT01053000|P2|Participant Flow|Right Arm Tazorac/Left Arm No Pretreatment|Tazorac 0.1% gel was applied for 1 week to the right arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
625837|NCT01058655|O1|Outcome|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625794|NCT01053000|P1|Participant Flow|Left Arm Tazorac/Right Arm No Tazorac Pre-treatment|Tazorac 0.1% gel was applied for 1 week to the left arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
625795|NCT01053000|O2|Outcome|No Pretreatment With Tzorac|"No pretreatmnet to the randomly chosen arm
20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
625796|NCT01053000|O1|Outcome|Tazorac Treated Arm|"Tazorac o.1% gel for 1 week to the randomly chosen arm
20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
625797|NCT01053000|E2|Reported Event|No Pretreatment Arm|"No Pretreatment to the randomly chosen arm
20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
625798|NCT01053000|E1|Reported Event|Tazorac Treated Arm|"Tazorac o.1% gel for 1 week to the randomly chosen arm
20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
625799|NCT01053078|B3|Baseline|Total|Total of all reporting groups
625800|NCT01053078|B2|Baseline|Placebo|"Naltrexone: 1 month treatment
Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
625801|NCT01053078|B1|Baseline|Naltrexone|"Double blind placebo comparable
Naltrexone: 1 month treatment
Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
625802|NCT01053078|P2|Participant Flow|Placebo|"Naltrexone: 1 month treatment
Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
625803|NCT01053078|P1|Participant Flow|Naltrexone|"Double blind placebo comparable
Naltrexone: 1 month treatment
Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
625804|NCT01053078|O2|Outcome|Placebo|"Naltrexone: 1 month treatment
Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
625805|NCT01053078|O1|Outcome|Naltrexone|"Double blind placebo comparable
Naltrexone: 1 month treatment
Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
625806|NCT01053078|E2|Reported Event|Placebo|"Naltrexone: 1 month treatment
Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
625807|NCT01053078|E1|Reported Event|Naltrexone|"Double blind placebo comparable
Naltrexone: 1 month treatment
Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
625808|NCT01058642|B5|Baseline|Total|Total of all reporting groups
625858|NCT01058668|E2|Reported Event|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
627989|NCT01059760|O3|Outcome|Change When Fed|
625809|NCT01058642|B4|Baseline|Treatment Sequence 4: ADL5747 Then Placebo|"ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days during 1 of 2 Treatment Periods.
Placebo: Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
625810|NCT01058642|B3|Baseline|Treatment Sequence 3: Placebo Then ADL5747|"Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.
ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods."
625811|NCT01058642|B2|Baseline|Treatment Sequence 2: Pregabalin Then Placebo|"Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
625812|NCT01058642|B1|Baseline|Treatment Sequence 1: Placebo Then Pregabalin|"Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.
Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period."
625813|NCT01058642|P4|Participant Flow|Treatment Sequence 4: ADL5747 Then Placebo|"During Treatment Period 1, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.
A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.
Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.
At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week."
625814|NCT01058642|P3|Participant Flow|Treatment Sequence 3: Placebo Then ADL5747|"Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.
A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.
During Treatment Period 2, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.
At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week"
625838|NCT01058655|O1|Outcome|Phase I: Evaluable|All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
625815|NCT01058642|P2|Participant Flow|Treatment Sequence 2: Pregabalin Then Placebo|"Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 1; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID).
At the end of Treatment Period 1 and the start of the first week of the 2-week washout period, participants took a tapered pregabalin dose (75 mg BID) during the first 3 days of the week, followed by placebo orally BID during the last 4 days.
Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.
At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week."
625816|NCT01058642|P1|Participant Flow|Treatment Sequence 1: Placebo Then Pregabalin|"Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.
A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.
Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 2; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID). This was followed by a dose of pregabalin 75 mg BID (1 pregabalin 75-mg capsule and 1 placebo capsule BID) for 3 days as a taper period followed by placebo orally BID during the last 4 days."
625817|NCT01058642|O3|Outcome|Pregabalin|Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
625818|NCT01058642|O2|Outcome|Placebo|"Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
625819|NCT01058642|O1|Outcome|ADL5747|ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
625820|NCT01058642|E3|Reported Event|Pregabalin|Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
625821|NCT01058642|E2|Reported Event|Placebo|"Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
625822|NCT01058642|E1|Reported Event|ADL5747|ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
625823|NCT01058655|B5|Baseline|Total|Total of all reporting groups
625824|NCT01058655|B4|Baseline|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625825|NCT01058655|B3|Baseline|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625826|NCT01058655|B2|Baseline|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625827|NCT01058655|B1|Baseline|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625828|NCT01058655|P4|Participant Flow|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625829|NCT01058655|P3|Participant Flow|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625830|NCT01058655|P2|Participant Flow|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625831|NCT01058655|P1|Participant Flow|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625832|NCT01058655|O1|Outcome|Phase II: Everolimus 10 mg + Tivozanib 1 mg [Evaluable]|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625833|NCT01058655|O1|Outcome|Phase II: Everolimus 10 mg + Tivozanib 1 mg [Evaluable]|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625834|NCT01058655|O1|Outcome|Phase II: Everolimus 10 mg + Tivozanib 1 mg [Evaluable]|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625835|NCT01058655|O3|Outcome|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625836|NCT01058655|O2|Outcome|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
626076|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
625839|NCT01058655|O1|Outcome|Phase I: Evaluable|All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
625840|NCT01058655|E4|Reported Event|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625841|NCT01058655|E3|Reported Event|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625842|NCT01058655|E2|Reported Event|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625843|NCT01058655|E1|Reported Event|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
625844|NCT01058668|B4|Baseline|Total|Total of all reporting groups
625845|NCT01058668|B3|Baseline|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
625846|NCT01058668|B2|Baseline|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
625847|NCT01058668|B1|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
625848|NCT01058668|P3|Participant Flow|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
625849|NCT01058668|P2|Participant Flow|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
625850|NCT01058668|P1|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
625851|NCT01058668|O3|Outcome|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
625852|NCT01058668|O2|Outcome|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
625853|NCT01058668|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
625854|NCT01058668|O3|Outcome|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
625855|NCT01058668|O2|Outcome|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
625856|NCT01058668|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
627162|NCT01069120|O2|Outcome|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
625860|NCT01058863|B1|Baseline|Randomized Treated Participants|Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
625861|NCT01058863|P1|Participant Flow|All Randomized Participants|Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
625862|NCT01058863|O1|Outcome|All Randomized Participants|Participants were randomized to one of five treatment arms, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
625863|NCT01058863|O5|Outcome|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
625864|NCT01058863|O4|Outcome|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
625865|NCT01058863|O3|Outcome|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
625866|NCT01058863|O2|Outcome|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
625867|NCT01058863|O1|Outcome|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
625868|NCT01058863|O5|Outcome|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
625869|NCT01058863|O4|Outcome|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
625870|NCT01058863|O3|Outcome|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
625871|NCT01058863|O2|Outcome|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
625872|NCT01058863|O1|Outcome|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
625873|NCT01058863|E5|Reported Event|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
625874|NCT01058863|E4|Reported Event|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
625875|NCT01058863|E3|Reported Event|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
625876|NCT01058863|E2|Reported Event|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
625877|NCT01058863|E1|Reported Event|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
625878|NCT01060059|B3|Baseline|Total|Total of all reporting groups
625879|NCT01060059|B2|Baseline|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625880|NCT01060059|B1|Baseline|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625881|NCT01060059|P2|Participant Flow|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625882|NCT01060059|P1|Participant Flow|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625883|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
625884|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
625885|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
625886|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
626005|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing
genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
625887|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
625888|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
625889|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
625890|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
625891|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
625892|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
625893|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
625894|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
625895|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
625896|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
625897|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
636078|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
625898|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625899|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625900|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625901|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625902|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625903|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625904|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625905|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625906|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625907|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
626055|NCT01061008|B2|Baseline|Treatment as Usual|
627163|NCT01069120|O1|Outcome|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
625908|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625909|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625910|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625911|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625912|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625913|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625914|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625915|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625916|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625917|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625918|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625919|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625920|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625921|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625922|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625923|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625924|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625925|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625926|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625927|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625928|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
626094|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
625929|NCT01060059|E2|Reported Event|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
625930|NCT01060059|E1|Reported Event|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
625931|NCT01060072|B3|Baseline|Total|Total of all reporting groups
625932|NCT01060072|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
625933|NCT01060072|B1|Baseline|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
625934|NCT01060072|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
625935|NCT01060072|P1|Participant Flow|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
625936|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
625937|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
625938|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
625939|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
625940|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
625941|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
625942|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
625943|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
625944|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
625945|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
625946|NCT01060072|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
625947|NCT01060072|E1|Reported Event|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
625948|NCT01060111|B4|Baseline|Total|Total of all reporting groups
625949|NCT01060111|B3|Baseline|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
625950|NCT01060111|B2|Baseline|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
625973|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
625951|NCT01060111|B1|Baseline|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
625952|NCT01060111|P3|Participant Flow|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
625953|NCT01060111|P2|Participant Flow|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
625954|NCT01060111|P1|Participant Flow|Topiramate Standard|Topiramate 25 milligram (mg) was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
625955|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
625956|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
625957|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
625958|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
625959|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
625960|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
625961|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
625962|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
625963|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
625964|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
625965|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
625966|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
625967|NCT01060111|E3|Reported Event|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
625968|NCT01060111|E2|Reported Event|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
625969|NCT01060111|E1|Reported Event|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
625970|NCT01060124|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
625971|NCT01060124|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
625972|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
625974|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
625975|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
625976|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
625977|NCT01060124|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
625978|NCT01060150|B1|Baseline|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625979|NCT01060150|P1|Participant Flow|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625980|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625981|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625982|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
626095|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
625983|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625984|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625985|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625986|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625987|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625988|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625989|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625990|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
636082|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
625991|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625992|NCT01060150|E1|Reported Event|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
625993|NCT01060540|B3|Baseline|Total|Total of all reporting groups
625994|NCT01060540|B2|Baseline|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
625995|NCT01060540|B1|Baseline|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
625996|NCT01060540|P2|Participant Flow|CR+EYE|"conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)
eye disease counseling"
625997|NCT01060540|P1|Participant Flow|CR+G|"conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)
results of genetic testing for type 2 diabetes based on the genes TCF7L2, PPARG, or KCNJ11"
625998|NCT01060540|O2|Outcome|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
625999|NCT01060540|O1|Outcome|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
626000|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling
Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
626001|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing
genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
626002|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling
Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
626003|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing
genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
626004|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling
Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
626096|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
626006|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling
Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
626007|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing
genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
626008|NCT01060540|E2|Reported Event|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
626009|NCT01060540|E1|Reported Event|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
626010|NCT01060553|B1|Baseline|Arm 1|24 semi-individualized acupuncture treatments over 12 weeks. The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
626011|NCT01060553|P2|Participant Flow|Wait List Control|this group was originall randomly assigned to a wait list control. due to severe recruitment and retention problems, data was collected in those willing to be treated after the wait list. this treatment data is combined with the original treatment group. this group received the same treatment, namely The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
626012|NCT01060553|P1|Participant Flow|Active Treatment|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used."
626040|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
626041|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
627370|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
626013|NCT01060553|O1|Outcome|Arm 1|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used."
626014|NCT01060553|O1|Outcome|Arm 1|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
Acupuncture treatment: This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment"
626015|NCT01060553|E1|Reported Event|Arm 1|The treatment program will consist of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
626016|NCT01060592|B3|Baseline|Total|Total of all reporting groups
626017|NCT01060592|B2|Baseline|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
626018|NCT01060592|B1|Baseline|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
626019|NCT01060592|P2|Participant Flow|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
626020|NCT01060592|P1|Participant Flow|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
626021|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
626022|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
626023|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
626024|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
626025|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
626026|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
626027|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
626028|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
626029|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
626030|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
626031|NCT01060592|E2|Reported Event|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
626032|NCT01060592|E1|Reported Event|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
626033|NCT01060670|B3|Baseline|Total|Total of all reporting groups
626034|NCT01060670|B2|Baseline|Control Treatment|Control Treatment consisted of moist wound therapy and was comprised of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing and a gauze wrap and, an offloading/protective device
626035|NCT01060670|B1|Baseline|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing and a gauze wrap and, an offloading/protective device were to be used in conjunction with the IDRT.
626036|NCT01060670|P2|Participant Flow|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
626037|NCT01060670|P1|Participant Flow|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
626038|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
626039|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
626042|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
626043|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
626044|NCT01060670|O2|Outcome|Moist Wound Therapy|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
626045|NCT01060670|O1|Outcome|Dermal Replacement Device|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
626046|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
626047|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
626048|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
626049|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
626050|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
626051|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
626052|NCT01060670|E2|Reported Event|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
626053|NCT01060670|E1|Reported Event|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
626054|NCT01061008|B3|Baseline|Total|Total of all reporting groups
626056|NCT01061008|B1|Baseline|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
626057|NCT01061008|P2|Participant Flow|Treatment as Usual|
626058|NCT01061008|P1|Participant Flow|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
626059|NCT01061008|O2|Outcome|Treatment as Usual|
626060|NCT01061008|O1|Outcome|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
626061|NCT01061008|E2|Reported Event|Treatment as Usual|
626062|NCT01061008|E1|Reported Event|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
626063|NCT01061034|B1|Baseline|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
626064|NCT01061034|P1|Participant Flow|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
626065|NCT01061034|O1|Outcome|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
626066|NCT01061034|O1|Outcome|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
626067|NCT01061034|E1|Reported Event|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
626068|NCT01061177|B1|Baseline|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626069|NCT01061177|P1|Participant Flow|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626070|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626071|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626072|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626073|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626074|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626075|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626077|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626078|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626079|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626080|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626081|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626082|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626083|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626084|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626085|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626086|NCT01061177|E1|Reported Event|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
626087|NCT01061333|B1|Baseline|All Participants|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, nedocromil or montelukast, nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
626088|NCT01061333|P2|Participant Flow|Placebo-Nedocromil-Montelukast-Mometasone|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
626089|NCT01061333|P1|Participant Flow|Placebo-Montelukast-Nedocromil-Mometasone|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
626090|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
626091|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
626092|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
626093|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
626097|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
626098|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
626099|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
626100|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
626101|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
626102|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
626103|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
626104|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
626105|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
626106|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
626107|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
626108|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
626109|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
626110|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
626111|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
626112|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
626113|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
626114|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
626115|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
626116|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
626117|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, Montelukast placebo tablet, Mometasone placebo twisthaler
626118|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
626119|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
626120|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
626121|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
626122|NCT01061333|E4|Reported Event|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
626125|NCT01061333|E1|Reported Event|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
626126|NCT01061359|B1|Baseline|Entire Study Population|Includes all groups enrolled in the study
626127|NCT01061359|P1|Participant Flow|Entire Study Population|Includes all groups enrolled in the study
626128|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
626129|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
626130|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
626131|NCT01061359|E1|Reported Event|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
626132|NCT01061385|B3|Baseline|Total|Total of all reporting groups
626133|NCT01061385|B2|Baseline|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.
Behavioral modification: Diet and exercise"
626134|NCT01061385|B1|Baseline|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
626135|NCT01061385|P2|Participant Flow|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.
Behavioral modification: Diet and exercise"
626136|NCT01061385|P1|Participant Flow|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
626137|NCT01061385|O2|Outcome|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.
Behavioral modification: Diet and exercise"
626138|NCT01061385|O1|Outcome|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
626139|NCT01061385|O2|Outcome|Control|Control subjects receiving diet and exercise counseling only
626140|NCT01061385|O1|Outcome|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
626141|NCT01061385|E2|Reported Event|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.
Behavioral modification: Diet and exercise"
626142|NCT01061385|E1|Reported Event|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
626143|NCT01061476|B1|Baseline|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.
Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
626144|NCT01061476|P1|Participant Flow|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.
Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
626145|NCT01061476|O1|Outcome|Single Arm - Sleep Apnea|"Each participant had 3 sleep studies. Sleep Study #1 - the patient did not have the Provent™ device on to assess baseline sleep apnea severity. On sleep study #2 - the patient used the Provent™ device to re-assess changes in sleep apnea severity. On sleep study #3, the patient used Provent™ for assessment of the physiological effects of the device on breathing during sleep.
Participants did not use Provent™ outside of the sleep laboratory.
Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
626146|NCT01061476|E1|Reported Event|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.
Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
626147|NCT01061567|B1|Baseline|All Patients|Patients with Parkinson’s disease in routine clinical practice.
626148|NCT01061567|P1|Participant Flow|All Patients|Patients with Parkinson’s disease in routine clinical practice.
626149|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
626150|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
626151|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
626152|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
626153|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
626154|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
626155|NCT01061567|E1|Reported Event|All Patients|Patients with Parkinson’s disease in routine clinical practice.
626156|NCT01061606|B1|Baseline|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV"
626157|NCT01061606|P1|Participant Flow|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV"
626158|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV"
626159|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV"
626160|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV"
626161|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV"
626262|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626162|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV"
626163|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV"
626164|NCT01061606|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV"
626165|NCT01061671|B3|Baseline|Total|Total of all reporting groups
626166|NCT01061671|B2|Baseline|Placebo|"Matched placebo pill daily
Placebo: Matched placebo pill daily"
626167|NCT01061671|B1|Baseline|Simvastatin|"40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily"
626168|NCT01061671|P2|Participant Flow|Placebo|"Matched placebo pill daily
Placebo: Matched placebo pill daily"
626169|NCT01061671|P1|Participant Flow|Simvastatin|"40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily"
626170|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily
Placebo: Matched placebo pill daily"
626171|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily"
626172|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily
Placebo: Matched placebo pill daily"
626173|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily"
626174|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily
Placebo: Matched placebo pill daily"
626175|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily"
626176|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily
Placebo: Matched placebo pill daily"
626177|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily"
626178|NCT01061671|E2|Reported Event|Placebo|"Matched placebo pill daily
Placebo: Matched placebo pill daily"
626179|NCT01061671|E1|Reported Event|Simvastatin|"40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily"
626180|NCT01061710|B1|Baseline|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
626181|NCT01061710|P1|Participant Flow|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
626182|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
626183|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
626184|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
626185|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
626186|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
626187|NCT01061710|E1|Reported Event|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
626188|NCT01061723|B7|Baseline|Total|Total of all reporting groups
626189|NCT01061723|B6|Baseline|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626190|NCT01061723|B5|Baseline|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626191|NCT01061723|B4|Baseline|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626192|NCT01061723|B3|Baseline|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626193|NCT01061723|B2|Baseline|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626194|NCT01061723|B1|Baseline|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626195|NCT01061723|P6|Participant Flow|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626196|NCT01061723|P5|Participant Flow|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626197|NCT01061723|P4|Participant Flow|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626198|NCT01061723|P3|Participant Flow|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626263|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626199|NCT01061723|P2|Participant Flow|Sarilumab 100 mg q2w|Sarilumab 100 mg subcutaneous (SC) injection alternating with placebo q2w for 12 weeks.
626200|NCT01061723|P1|Participant Flow|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626201|NCT01061723|O6|Outcome|Sarilumab 150mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626202|NCT01061723|O5|Outcome|Sarilumab 200mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626203|NCT01061723|O4|Outcome|Sarilumab 100mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626204|NCT01061723|O3|Outcome|Sarilumab 150mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626205|NCT01061723|O2|Outcome|Sarilumab 100mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626206|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626207|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626208|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626209|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626210|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626211|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626212|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626213|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626214|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626215|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626216|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626217|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626218|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626219|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626220|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626221|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626222|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626223|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626224|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626225|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626226|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626228|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626229|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626230|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626231|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626232|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626233|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626234|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626235|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626236|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626237|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626238|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626239|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626240|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626241|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626242|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626243|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626244|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626245|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626246|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626247|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626248|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626249|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626250|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626251|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626252|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626253|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626254|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626255|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626256|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626257|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626258|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626264|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626265|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626266|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626267|NCT01061723|O6|Outcome|Sarilumab 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626268|NCT01061723|O5|Outcome|Sarilumab 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
626269|NCT01061723|O4|Outcome|Sarilumab 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626270|NCT01061723|O3|Outcome|Sarilumab 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
626271|NCT01061723|O2|Outcome|Sarilumab 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626272|NCT01061723|O1|Outcome|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626273|NCT01061723|E6|Reported Event|SAR153191 150 mg qw|Sarilumab 150 mg SC injection qw for 12 weeks.
626274|NCT01061723|E5|Reported Event|SAR153191 200 mg q2w|Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. Excluded a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error.
626275|NCT01061723|E4|Reported Event|SAR153191 100 mg qw|Sarilumab 100 mg SC injection qw for 12 weeks.
626276|NCT01061723|E3|Reported Event|SAR153191 150 mg q2w|Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. Included a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error.
626277|NCT01061723|E2|Reported Event|SAR153191 100 mg q2w|Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.
626278|NCT01061723|E1|Reported Event|Placebo|Placebo (for sarilumab) qw for 12 weeks.
626279|NCT01061736|B11|Baseline|Total|Total of all reporting groups
626280|NCT01061736|B10|Baseline|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
626281|NCT01061736|B9|Baseline|Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
626562|NCT01068262|B2|Baseline|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.
626282|NCT01061736|B8|Baseline|Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
626283|NCT01061736|B7|Baseline|Part B Cohort 1: Non-selected Doses|Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
626284|NCT01061736|B6|Baseline|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
626285|NCT01061736|B5|Baseline|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
626286|NCT01061736|B4|Baseline|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
626287|NCT01061736|B3|Baseline|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
626288|NCT01061736|B2|Baseline|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
626289|NCT01061736|B1|Baseline|Part A: SAR 100 mg qw|Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
626290|NCT01061736|P10|Participant Flow|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
626291|NCT01061736|P9|Participant Flow|Part B: SAR 200 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)|Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
626292|NCT01061736|P8|Participant Flow|Part B: SAR 150 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)|Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
626293|NCT01061736|P7|Participant Flow|Part B Cohort 1: Non-selected Doses|Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections as in Part A on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
626294|NCT01061736|P6|Participant Flow|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
626295|NCT01061736|P5|Participant Flow|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
626296|NCT01061736|P4|Participant Flow|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
626297|NCT01061736|P3|Participant Flow|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.
626298|NCT01061736|P2|Participant Flow|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
626299|NCT01061736|P1|Participant Flow|Part A: SAR 100 mg qw|Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of methotrexate (MTX) for 12 weeks.
626300|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.
626301|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
626302|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
626303|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.
626334|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
626304|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
626305|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
626306|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.
626307|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
626308|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
626309|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks
626310|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
626311|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
626312|NCT01061736|O6|Outcome|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
626313|NCT01061736|O5|Outcome|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
626314|NCT01061736|O4|Outcome|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
626315|NCT01061736|O3|Outcome|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
626316|NCT01061736|O2|Outcome|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
626317|NCT01061736|O1|Outcome|Part A: SAR 100 mg qw|Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
626318|NCT01061736|E13|Reported Event|Part B Sarilumab Rescue: Cohort 1(Selected Doses)+Cohort2|Part B participants exposed to sarilumab 150 mg q2w or 200 mg q2w or placebo q2w, without adequate response from Week 16, rescued with high dose of sarilumab (SAR 200 mg q2w) (mean exposure of 49 weeks from beginning of randomization to the end of rescue treatment).
626349|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
627164|NCT01069120|E2|Reported Event|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
626319|NCT01061736|E12|Reported Event|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to placebo q2w on top of MTX (mean exposure of 40 weeks). 168 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 1 participant randomized to placebo q2w who received sarilumab 200 mg q2w in error. He/she was considered in the 200 mg q2w treatment group for safety analysis.
626320|NCT01061736|E11|Reported Event|Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 42 weeks). 55 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error and included a participant randomized to placebo q2w who received sarilumab 200 mg q2w in error.
626321|NCT01061736|E10|Reported Event|Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 42 weeks). 61 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Included 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error.
626322|NCT01061736|E9|Reported Event|Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 13 weeks). Included 1 participant who received sarilumab 100 mg q2w in error.
626323|NCT01061736|E8|Reported Event|Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received sarilumab 100 mg q2w in error. He/she was considered in the 100 mg q2w treatment group for safety analysis.
626324|NCT01061736|E7|Reported Event|Part B: SAR 100 mg qw Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
626325|NCT01061736|E6|Reported Event|Part A: Placebo qw|Part A participants exposed to placebo on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received an erroneous IMP kit with sarilumab 150 mg q2w. He/she was considered in the 150 mg q2w treatment group for safety analysis.
626326|NCT01061736|E5|Reported Event|Part A: SAR 200 mg q2w|Part A participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 11 weeks).
626327|NCT01061736|E4|Reported Event|Part A: SAR 150 mg q2w|Part A participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 12 weeks). Included the participant randomized to placebo qw who received sarilumab 150 mg q2w in error.
626328|NCT01061736|E3|Reported Event|Part A: SAR 100 mg q2w|Part A participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 11 weeks).
626329|NCT01061736|E2|Reported Event|Part A: SAR 150 mg qw|Part A participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks).
626330|NCT01061736|E1|Reported Event|Part A: SAR 100 mg qw|Part A participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
626331|NCT01061775|B1|Baseline|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
626332|NCT01061775|P1|Participant Flow|Exenatide|Participants received 5mcg of exenatide twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.
626333|NCT01061775|O1|Outcome|Exenatide|"Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
Of 55 potential participants screened, 19 agreed to participate. Reasons for decline included reluctance to add another medication to their current regimens, travel distance, and aversion to an injectable medication. Sixteen patients completed the study. Of the three who failed to complete the study, one was lost to follow up, and two dropped out due to difficulty adhering to the twice daily injections, but none experienced significant side effects from therapy. Three of the 19 patients were on chronic metformin therapy."
626335|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
626336|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
626337|NCT01061775|E1|Reported Event|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
626338|NCT01061866|B1|Baseline|Thalidomide|Tablets thalidomide at 200 mg dosage 100 mg in the morning and 100 mg in the night was administered daily during a twelve month period.
626339|NCT01061866|P1|Participant Flow|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
626340|NCT01061866|O1|Outcome|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
626341|NCT01061866|E1|Reported Event|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
626342|NCT01062061|B1|Baseline|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626343|NCT01062061|P1|Participant Flow|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626344|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626345|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626346|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626347|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626348|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626350|NCT01062061|O2|Outcome|Age ≥2 Years|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626351|NCT01062061|O1|Outcome|Age <2 Years|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626352|NCT01062061|O2|Outcome|Female Participants|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626353|NCT01062061|O1|Outcome|Male Participants|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626354|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626355|NCT01062061|E1|Reported Event|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
626356|NCT01062074|B1|Baseline|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
626357|NCT01062074|P1|Participant Flow|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
626358|NCT01062074|O1|Outcome|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
626359|NCT01062074|O1|Outcome|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
626360|NCT01062074|E1|Reported Event|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
626361|NCT01062113|B4|Baseline|Total|Total of all reporting groups
626362|NCT01062113|B3|Baseline|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626363|NCT01062113|B2|Baseline|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626364|NCT01062113|B1|Baseline|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
626365|NCT01062113|P3|Participant Flow|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626366|NCT01062113|P2|Participant Flow|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626367|NCT01062113|P1|Participant Flow|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
626368|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626369|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626370|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626371|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626372|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626373|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200mg|Included participants who received Celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626374|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626375|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626376|NCT01062113|E3|Reported Event|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626377|NCT01062113|E2|Reported Event|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
626378|NCT01062113|E1|Reported Event|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
626379|NCT01062165|B1|Baseline|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
626380|NCT01062165|P1|Participant Flow|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
626381|NCT01062165|O1|Outcome|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
626382|NCT01062165|E1|Reported Event|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
626383|NCT01062230|B1|Baseline|All Patients|"All participants enrolled.
Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.
Patients will undergo three 21-day cycles."
626439|NCT01062425|B1|Baseline|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
626384|NCT01062230|P1|Participant Flow|All Patients|"All participants enrolled.
Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.
Patients will undergo three 21-day cycles."
626385|NCT01062230|O1|Outcome|All Patients|"All participants enrolled.
Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.
Patients will undergo three 21-day cycles."
626386|NCT01062230|E1|Reported Event|All Patients|"All participants enrolled.
Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.
Patients will undergo three 21-day cycles."
626387|NCT01062256|B4|Baseline|Total|Total of all reporting groups
626388|NCT01062256|B3|Baseline|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
626389|NCT01062256|B2|Baseline|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
626390|NCT01062256|B1|Baseline|Placebo|One placebo tablet administered orally as a single dose
626391|NCT01062256|P3|Participant Flow|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
626392|NCT01062256|P2|Participant Flow|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
626393|NCT01062256|P1|Participant Flow|Placebo|One placebo tablet administered orally as a single dose
626394|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
626395|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
626396|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
626397|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
626398|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
626399|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
626400|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
626401|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
626402|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
626403|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
626404|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
626405|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
626406|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
626407|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
626408|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
626409|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
626410|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
626411|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
626412|NCT01062256|E3|Reported Event|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
626413|NCT01062256|E2|Reported Event|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
626414|NCT01062256|E1|Reported Event|Placebo|One placebo tablet administered orally as a single dose
626541|NCT01067976|O1|Outcome|UMRM|
626542|NCT01067976|O1|Outcome|CMRM vs UMRM|
626415|NCT01062269|B1|Baseline|Cholestyramine 4 Grams vs 12 Grams vs Tang|Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
626416|NCT01062269|P1|Participant Flow|Cholestyramine 4 Grams vs 12 Grams vs Tang|Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
626417|NCT01062269|O3|Outcome|Tang|
626418|NCT01062269|O2|Outcome|Cholestyramine 12 Grams|
626419|NCT01062269|O1|Outcome|Cholestyramine 4 Grams|
626420|NCT01062269|O3|Outcome|Tang|
626421|NCT01062269|O2|Outcome|Cholestyramine 12 Grams|
626422|NCT01062269|O1|Outcome|Cholestyramine 4 Grams|
626423|NCT01062269|E3|Reported Event|Tang|
626424|NCT01062269|E2|Reported Event|Cholestyramine 12 Grams|
626425|NCT01062269|E1|Reported Event|Cholestyramine 4 Grams|
626426|NCT01062308|B3|Baseline|Total|Total of all reporting groups
626427|NCT01062308|B2|Baseline|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
626428|NCT01062308|B1|Baseline|Taping|Procedure for preventing shoulder injury
626429|NCT01062308|P2|Participant Flow|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
626430|NCT01062308|P1|Participant Flow|Taping|Procedure for preventing shoulder injury
626431|NCT01062308|O2|Outcome|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
626432|NCT01062308|O1|Outcome|Taping|Procedure for preventing shoulder injury
626433|NCT01062308|O2|Outcome|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
626434|NCT01062308|O1|Outcome|Taping|Procedure for preventing shoulder injury
626435|NCT01062308|E2|Reported Event|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
626436|NCT01062308|E1|Reported Event|Taping|Procedure for preventing shoulder injury
626437|NCT01062425|B3|Baseline|Total|Total of all reporting groups
626438|NCT01062425|B2|Baseline|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
626461|NCT01062763|B3|Baseline|Total|Total of all reporting groups
626462|NCT01062763|B2|Baseline|Placebo|
626440|NCT01062425|P2|Participant Flow|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
626441|NCT01062425|P1|Participant Flow|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
626442|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
626443|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
626444|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
626445|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
626446|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
626447|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
626448|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
626449|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
626450|NCT01062425|E2|Reported Event|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
626451|NCT01062425|E1|Reported Event|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
626452|NCT01056016|B3|Baseline|Total|Total of all reporting groups
626453|NCT01056016|B2|Baseline|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.
ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
626454|NCT01056016|B1|Baseline|Wait-list Control|Wait-list control group
626584|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626455|NCT01056016|P2|Participant Flow|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to American Academy of Pediatrics (AAP) ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics include the importance of obtaining parent and teacher behavioral ratings at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.
ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
626456|NCT01056016|P1|Participant Flow|Wait-list Control|Wait-list control group
626457|NCT01056016|O2|Outcome|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.
ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
626458|NCT01056016|O1|Outcome|Wait-list Control|Wait-list control group
626459|NCT01056016|E2|Reported Event|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.
ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
626460|NCT01056016|E1|Reported Event|Wait-list Control|Wait-list control group
626463|NCT01062763|B1|Baseline|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment
placebo : addition of placebo 1 to 2 tablets daily
spironolactone : 25 to 50 mg once daily"
626464|NCT01062763|P2|Participant Flow|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment
placebo : addition of placebo 1 to 2 tablets daily
spironolactone : 25 to 50 mg once daily"
626465|NCT01062763|P1|Participant Flow|Placebo|1tablet of matching placebo trated up to 2 if neccessary
626466|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
626467|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment
spironolactone : 25 uptrated if necessary to 50 mg once daily"
626468|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
626469|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment
spironolactone : 25 uptrated if necessary to 50 mg once daily"
626470|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
626471|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment
spironolactone : 25 uptrated if necessary to 50 mg once daily"
626472|NCT01062763|E2|Reported Event|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
626473|NCT01062763|E1|Reported Event|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment
spironolactone : 25 uptrated if necessary to 50 mg once daily"
626474|NCT01067846|B3|Baseline|Total|Total of all reporting groups
626475|NCT01067846|B2|Baseline|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
626476|NCT01067846|B1|Baseline|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
626477|NCT01067846|P2|Participant Flow|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
626478|NCT01067846|P1|Participant Flow|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
626479|NCT01067846|O2|Outcome|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
626480|NCT01067846|O1|Outcome|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
626481|NCT01067846|O2|Outcome|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
626482|NCT01067846|O1|Outcome|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
626483|NCT01067846|E2|Reported Event|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
626484|NCT01067846|E1|Reported Event|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
626485|NCT01067976|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
626486|NCT01067976|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
626487|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
626488|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|
626561|NCT01068262|B3|Baseline|Healthy Postmenopausal Females: Odanacatib (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626489|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
626490|NCT01067976|O1|Outcome|CMRM|
626491|NCT01067976|O1|Outcome|CMRM|
626492|NCT01067976|O1|Outcome|CMRM|
626493|NCT01067976|O1|Outcome|CMRM vs UMRM|
626494|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
626495|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
626496|NCT01067976|O1|Outcome|CMRM vs UMRM|
626497|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
626498|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
626499|NCT01067976|O1|Outcome|CMRM vs UMRM|
626500|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
626501|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
626502|NCT01067976|O1|Outcome|CMRM vs UMRM|
626503|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
626504|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
626505|NCT01067976|O1|Outcome|CMRM vs UMRM|
626506|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
626507|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
626508|NCT01067976|O1|Outcome|CMRM vs UMRM|
626509|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
626510|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
626511|NCT01067976|O1|Outcome|CMRM vs UMRM|
626512|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
626513|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
626514|NCT01067976|O1|Outcome|CMRM vs UMRM|
626515|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
626516|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
626517|NCT01067976|O1|Outcome|CMRM vs UMRM|
626518|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
626519|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
626520|NCT01067976|O1|Outcome|CMRM vs UMRM|
626521|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
626522|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
626523|NCT01067976|O1|Outcome|CMRM vs UMRM|
626524|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
626525|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
626526|NCT01067976|O1|Outcome|CMRM vs UMRM|
626527|NCT01067976|O5|Outcome|CMRM+XRM|
626528|NCT01067976|O4|Outcome|UMRM+XRM|
626529|NCT01067976|O3|Outcome|X-ray Mammography (XRM)|
626530|NCT01067976|O2|Outcome|CMRM|After the administration of study drug, enhanced breast MRI were performed.
626531|NCT01067976|O1|Outcome|UMRM|Before the administration of study drug unenhanced breast MRI (UMRM) were performed.
626532|NCT01067976|O3|Outcome|CMRM vs CMRM+XRM|
626533|NCT01067976|O2|Outcome|CMRM vs XRM|
626534|NCT01067976|O1|Outcome|CMRM vs UMRM|
626535|NCT01067976|O3|Outcome|CMRM vs CMRM+XRM|
626536|NCT01067976|O2|Outcome|CMRM vs XRM|
626537|NCT01067976|O1|Outcome|CMRM vs UMRM|
626538|NCT01067976|O1|Outcome|CMRM|
626539|NCT01067976|O1|Outcome|CMRM|
626540|NCT01067976|O2|Outcome|CMRM|
626543|NCT01067976|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
626544|NCT01068158|B3|Baseline|Total|Total of all reporting groups
626545|NCT01068158|B2|Baseline|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
626546|NCT01068158|B1|Baseline|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
626547|NCT01068158|P2|Participant Flow|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
626548|NCT01068158|P1|Participant Flow|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
626549|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
626550|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
626551|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
626552|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
626553|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
626554|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
626555|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
626556|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
626557|NCT01068158|E2|Reported Event|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
626558|NCT01068158|E1|Reported Event|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
626559|NCT01068262|B5|Baseline|Total|Total of all reporting groups
626560|NCT01068262|B4|Baseline|Healthy Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
627990|NCT01059760|O2|Outcome|Change While Fasting|
626563|NCT01068262|B1|Baseline|Healthy Males: Odanacatib (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626564|NCT01068262|P4|Participant Flow|Healthy Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
626565|NCT01068262|P3|Participant Flow|Healthy Postmenopausal Females: Odanacatib (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626566|NCT01068262|P2|Participant Flow|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.
626567|NCT01068262|P1|Participant Flow|Healthy Males: Odanacatib (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered once weekly (Qw) for 4 consecutive weeks
626568|NCT01068262|O4|Outcome|Placebo in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
626569|NCT01068262|O3|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626570|NCT01068262|O2|Outcome|Placebo in Males (Panel A)|Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks
626571|NCT01068262|O1|Outcome|Odanacatib (MK-0822) in Males (Panel A)|Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626572|NCT01068262|O4|Outcome|Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
626573|NCT01068262|O3|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626574|NCT01068262|O2|Outcome|Placebo in Males (Panel A)|Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks
626575|NCT01068262|O1|Outcome|Odanacatib (MK-0822) in Males (Panel A)|Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626576|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626577|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626578|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626579|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626580|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626581|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626582|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626583|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
627371|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
626585|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626586|NCT01068262|O4|Outcome|Placebo in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
626587|NCT01068262|O3|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626588|NCT01068262|O2|Outcome|Placebo in Males (Panel A)|Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks
626589|NCT01068262|O1|Outcome|Odanacatib (MK-0822) in Males (Panel A)|Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626590|NCT01068262|E4|Reported Event|Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
626591|NCT01068262|E3|Reported Event|Postmenopausal Females: Odanacatib 50 mg (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626592|NCT01068262|E2|Reported Event|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks
626593|NCT01068262|E1|Reported Event|Healthy Males: Odanacatib 50 mg (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
626594|NCT01068418|B1|Baseline|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
626595|NCT01068418|P1|Participant Flow|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
626596|NCT01068418|O1|Outcome|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
626597|NCT01068418|O1|Outcome|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
626598|NCT01068418|E1|Reported Event|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
626599|NCT01068509|B4|Baseline|Total|Total of all reporting groups
626600|NCT01068509|B3|Baseline|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
626743|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626601|NCT01068509|B2|Baseline|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
626602|NCT01068509|B1|Baseline|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
626603|NCT01068509|P3|Participant Flow|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
626604|NCT01068509|P2|Participant Flow|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
626605|NCT01068509|P1|Participant Flow|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
626606|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
626607|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
626608|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
626609|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
626610|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
626611|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
626612|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
626613|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
626614|NCT01068509|E3|Reported Event|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
626615|NCT01068509|E2|Reported Event|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
626706|NCT01068665|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626616|NCT01068509|E1|Reported Event|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
626617|NCT01068548|B3|Baseline|Total|Total of all reporting groups
626618|NCT01068548|B2|Baseline|Arm 2|"post-implementation of computer based intervention
reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
626619|NCT01068548|B1|Baseline|Arm 1|pre-implementation of computer based intervention
626620|NCT01068548|P2|Participant Flow|Arm 2|"post-implementation of computer based intervention
reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
626621|NCT01068548|P1|Participant Flow|Arm 1|pre-implementation of computer based intervention
626622|NCT01068548|O2|Outcome|Arm 2|"post-implementation of computer based intervention
reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
626623|NCT01068548|O1|Outcome|Arm 1|pre-implementation of computer based intervention
626624|NCT01068548|E2|Reported Event|Arm 2|"post-implementation of computer based intervention
reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
626625|NCT01068548|E1|Reported Event|Arm 1|pre-implementation of computer based intervention
626626|NCT01068600|B3|Baseline|Total|Total of all reporting groups
626627|NCT01068600|B2|Baseline|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
626628|NCT01068600|B1|Baseline|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
626629|NCT01068600|P2|Participant Flow|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
626744|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626630|NCT01068600|P1|Participant Flow|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
626631|NCT01068600|O2|Outcome|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
626632|NCT01068600|O1|Outcome|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
626633|NCT01068600|O2|Outcome|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
626634|NCT01068600|O1|Outcome|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
626635|NCT01068600|E2|Reported Event|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
626636|NCT01068600|E1|Reported Event|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
626637|NCT01068626|B3|Baseline|Total|Total of all reporting groups
626638|NCT01068626|B2|Baseline|Placebo for Rosuvastatin|
626639|NCT01068626|B1|Baseline|Rosuvastatin|
626640|NCT01068626|P2|Participant Flow|Placebo for Rosuvastatin|
626641|NCT01068626|P1|Participant Flow|Rosuvastatin|
626642|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
626643|NCT01068626|O1|Outcome|Rosuvastatin|
626644|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
626645|NCT01068626|O1|Outcome|Rosuvastatin|
626646|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
626647|NCT01068626|O1|Outcome|Rosuvastatin|
626648|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
626649|NCT01068626|O1|Outcome|Rosuvastatin|
626650|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
626651|NCT01068626|O1|Outcome|Rosuvastatin|
626652|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
626653|NCT01068626|O1|Outcome|Rosuvastatin|
626654|NCT01068626|E2|Reported Event|Placebo for Rosuvastatin|
626655|NCT01068626|E1|Reported Event|Rosuvastatin|
626656|NCT01068652|B3|Baseline|Total|Total of all reporting groups
627372|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
626657|NCT01068652|B2|Baseline|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626658|NCT01068652|B1|Baseline|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626659|NCT01068652|P2|Participant Flow|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626660|NCT01068652|P1|Participant Flow|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626661|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626662|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626663|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
627165|NCT01069120|E1|Reported Event|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
626664|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626665|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626666|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626667|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626668|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626669|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626670|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626671|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626730|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
626672|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626673|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626674|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626675|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626676|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626677|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626678|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626745|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626679|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626680|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626681|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626682|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626683|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626684|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626685|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626686|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626687|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626688|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626689|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626690|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626691|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626692|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626693|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626746|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
626847|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626694|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626695|NCT01068652|E2|Reported Event|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
626696|NCT01068652|E1|Reported Event|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
626697|NCT01068665|B3|Baseline|Total|Total of all reporting groups
626698|NCT01068665|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626699|NCT01068665|B1|Baseline|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626700|NCT01068665|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626701|NCT01068665|P1|Participant Flow|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626702|NCT01068665|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626703|NCT01068665|O1|Outcome|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626704|NCT01068665|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626705|NCT01068665|O1|Outcome|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626875|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626707|NCT01068665|E1|Reported Event|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626708|NCT01068678|B3|Baseline|Total|Total of all reporting groups
626709|NCT01068678|B2|Baseline|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626710|NCT01068678|B1|Baseline|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626711|NCT01068678|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626712|NCT01068678|P1|Participant Flow|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626713|NCT01068678|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626714|NCT01068678|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626715|NCT01068678|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626716|NCT01068678|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626717|NCT01068678|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626718|NCT01068678|E1|Reported Event|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
626719|NCT01068717|B1|Baseline|All Treated|All participants who received study medication.
626720|NCT01068717|P4|Participant Flow|Treatment Schedule DCAB|(Treatment D) a single oral dose of 2.5-mg saxagliptin/500- mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state. Then, (Treatment A) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500- mg metformin FDC administered in the fasted state.
626721|NCT01068717|P3|Participant Flow|Treatment Schedule CBDA|(Treatment C) A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the fed state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment A) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state.
626722|NCT01068717|P2|Participant Flow|Treatment Schedule BACD|(Treatment B) A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment A) a single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state.
626723|NCT01068717|P1|Participant Flow|Treatment Schedule ADBC|(Treatment A) A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state.
626724|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626725|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626726|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
626727|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626728|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626729|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626790|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
626731|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626732|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626733|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626734|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
626735|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626736|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626737|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626738|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
626739|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626740|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626741|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626742|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
627991|NCT01059760|O1|Outcome|Baseline Value|
626747|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626748|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626749|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626750|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
626751|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626752|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626753|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626754|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
626755|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626756|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626757|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626758|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
626759|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626760|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626761|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626762|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
626763|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626764|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626765|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626766|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
626767|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626768|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626769|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
626770|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
626771|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
626772|NCT01068717|E4|Reported Event|Fed: 2.5mg Saxa/500mg Metformin FDC|
626773|NCT01068717|E3|Reported Event|Fed: 2.5mg Onglyza + 500mg Glucophage|
626774|NCT01068717|E2|Reported Event|Fasted: 2.5mg Saxa/500mg Metformin FDC|
626775|NCT01068717|E1|Reported Event|Fasted: 2.5mg Onglyza + 500mg Glucophage|
626776|NCT01068730|B1|Baseline|All Enrolled and Treated Participants|Participants who were randomly assigned to 1 of 4 treatment sequences (ADBC, BACD, CBDA, or DCAB). Treatment A: single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment B: single oral 500-mg Glucophage tablet administered under fed condition. Treatment C: single oral 1000-mg Diabex tablet administered under fed condition.Treatment D: single oral 1000-mg Glucophage (metformin) tablet administered under fed condition.
626777|NCT01068730|P4|Participant Flow|Treatment Sequence DCAB|Treatment D (period 1): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment C (period 2): single oral 1000-mg Diabex tablet administered under fed condition. Treatment A (period 3): single oral 500-mg Diabex tablet administered under fed condition. Treatment B (period 4): single oral 500-mg Glucophage tablet administered under fed condition.
626778|NCT01068730|P3|Participant Flow|Treatment Sequence CBDA|Treatment C (period 1): single oral 1000-mg Diabex tablet administered under fed condition. Treatment B (period 2): single oral 500-mg Glucophage tablet administered under fed condition. Treatment D (period 3): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment A (period 4): single oral 500-mg Diabex tablet administered under fed condition.
626779|NCT01068730|P2|Participant Flow|Treatment Sequence BACD|Treatment B (period 1): single oral 500-mg Glucophage tablet administered under fed condition. Treatment A (period 2): single oral 500-mg Diabex tablet administered under fed condition. Treatment C (period 3): single oral 1000-mg Diabex tablet administered under fed condition. Treatment D (period 4): single oral 1000-mg Glucophage tablet administered under fed condition.
626780|NCT01068730|P1|Participant Flow|Treatment Sequence ADBC|Treatment A (period 1): single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment D (period 2): single oral 1000-mg Glucophage (metformin) tablet administered under fed condition. Treatment B (period 3): single oral 500-mg Glucophage tablet administered under fed condition. Treatment C (period 4): single oral 1000-mg Diabex tablet administered under fed condition.
626781|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
626782|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|Single oral dose of 1000 mg Diabex tablet administered in the fed condition
626783|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
626784|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
626785|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
626786|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
626787|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
626788|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
626789|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
626874|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626791|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
626792|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
626793|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
626794|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
626795|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
626796|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
626797|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
626798|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|Single oral dose of 1000 mg Diabex tablet administered in the fed condition
626799|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|Single oral dose of 500 mg Glucophage tablet administered in the fed condition
626800|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
626801|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
626802|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
626803|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
626804|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
626805|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
626806|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
626807|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
626808|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
626809|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
626846|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626810|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
626811|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
626812|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
626813|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
626814|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
626815|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
626816|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
626817|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
626818|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
626819|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
626820|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
626821|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
626822|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
626823|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
626824|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
626825|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
626826|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
626827|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
626828|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
626829|NCT01068730|E4|Reported Event|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
626830|NCT01068730|E3|Reported Event|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
626831|NCT01068730|E2|Reported Event|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
626832|NCT01068730|E1|Reported Event|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
626833|NCT01068743|B1|Baseline|All Enrolled and Treated Participants|
626834|NCT01068743|P4|Participant Flow|Treatment Sequence DCAB|Treatment D (period 1): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment C (period 2): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment A (period 3): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment B (period 4): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition.
626835|NCT01068743|P3|Participant Flow|Treatment Sequence CBDA|Treatment C (period 1): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment B (period 2): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment D (period 3): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment A (period 4): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition.
626836|NCT01068743|P2|Participant Flow|Treatment Sequence BACD|Treatment B (period 1): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment A (period 2): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment C (period 3): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment D (period 4): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition.
626837|NCT01068743|P1|Participant Flow|Treatment Sequence ADBC|Treatment A (period 1): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment D (period 2): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment B (period 3): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment C (period 4): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition.
626838|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626839|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626840|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626841|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626842|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626843|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626844|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626845|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626848|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626849|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626850|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626851|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626852|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626853|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626854|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626855|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626856|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626857|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626858|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626859|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626860|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626861|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626862|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626863|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626864|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626865|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626866|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626867|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626868|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626869|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626870|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626871|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626872|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626873|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
627373|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
626876|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626877|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626878|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626879|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626880|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626881|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626882|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition.
626883|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition.
626884|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626885|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition.
626886|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626887|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626888|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626889|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626890|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626891|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626892|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626893|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626894|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626895|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626896|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626897|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626898|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626899|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626900|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626901|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626902|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626903|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626904|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626905|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626906|NCT01068743|E4|Reported Event|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
626907|NCT01068743|E3|Reported Event|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
626908|NCT01068743|E2|Reported Event|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
626909|NCT01068743|E1|Reported Event|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
626910|NCT01068769|B1|Baseline|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
626911|NCT01068769|P1|Participant Flow|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
626912|NCT01068769|O1|Outcome|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
626913|NCT01068769|O1|Outcome|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
626914|NCT01068769|E1|Reported Event|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
626915|NCT01068821|B3|Baseline|Total|Total of all reporting groups
626916|NCT01068821|B2|Baseline|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
626917|NCT01068821|B1|Baseline|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
626918|NCT01068821|P2|Participant Flow|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
626919|NCT01068821|P1|Participant Flow|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
626920|NCT01068821|O2|Outcome|Gel Pad|Patient positioned on gel pad during surgery
626921|NCT01068821|O1|Outcome|Egg Crate Foam Mattress|Patient positioned on egg crate foam mattress during surgery
626922|NCT01068821|O2|Outcome|Gel Pad|Patient positioned on gel pad during surgery
626923|NCT01068821|O1|Outcome|Egg Crate Foam Mattress|Patient positioned on egg crate foam mattress during surgery
626924|NCT01068821|E2|Reported Event|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
626925|NCT01068821|E1|Reported Event|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
626926|NCT01068860|B11|Baseline|Total|Total of all reporting groups
626927|NCT01068860|B10|Baseline|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626928|NCT01068860|B9|Baseline|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626929|NCT01068860|B8|Baseline|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626930|NCT01068860|B7|Baseline|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626931|NCT01068860|B6|Baseline|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626932|NCT01068860|B5|Baseline|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627992|NCT01059760|E2|Reported Event|Fed Day First|Includes those who fasted on the 2nd day.
626933|NCT01068860|B4|Baseline|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626934|NCT01068860|B3|Baseline|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626935|NCT01068860|B2|Baseline|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626936|NCT01068860|B1|Baseline|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626937|NCT01068860|P10|Participant Flow|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626938|NCT01068860|P9|Participant Flow|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626939|NCT01068860|P8|Participant Flow|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626940|NCT01068860|P7|Participant Flow|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626941|NCT01068860|P6|Participant Flow|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626942|NCT01068860|P5|Participant Flow|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627180|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
626943|NCT01068860|P4|Participant Flow|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626944|NCT01068860|P3|Participant Flow|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626945|NCT01068860|P2|Participant Flow|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626946|NCT01068860|P1|Participant Flow|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626947|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626948|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626949|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626950|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626951|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626952|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626953|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626954|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626955|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626956|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626957|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626958|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626959|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626960|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626961|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627374|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
626962|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626963|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626964|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626965|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626966|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626967|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626968|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626969|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626970|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627993|NCT01059760|E1|Reported Event|Fasting Day First|Includes those who fasted on the 1st day.
626971|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626972|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626973|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626974|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626975|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626976|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626977|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626978|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626979|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626980|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626981|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626982|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626983|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626984|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626985|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626986|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626987|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626988|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626989|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626990|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
626991|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626992|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626993|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626994|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
626995|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626996|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
626997|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626998|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
626999|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627000|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627001|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627002|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627003|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627004|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627005|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627006|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627007|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627008|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627009|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627010|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627011|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627012|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627013|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627014|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627015|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627016|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627017|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627018|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627019|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627020|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627021|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627022|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627023|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627024|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627025|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627026|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627128|NCT01068912|E2|Reported Event|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
627994|NCT01059773|B3|Baseline|Total|Total of all reporting groups
627027|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627028|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627029|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627030|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627031|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627032|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627033|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627034|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627035|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627036|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627037|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627038|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627039|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627040|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627041|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627042|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627043|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627044|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627129|NCT01068912|E1|Reported Event|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
627130|NCT01068964|B3|Baseline|Total|Total of all reporting groups
627045|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627046|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627047|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627048|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627049|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627050|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627051|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627052|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627053|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627054|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627055|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627056|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627057|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627058|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627059|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627060|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627061|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627062|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627063|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627064|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627065|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627066|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627067|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627068|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627069|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627070|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627071|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627072|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627073|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627074|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627075|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627076|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627077|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627078|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627079|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627080|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627081|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627082|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627083|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627084|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627085|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627086|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627087|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627088|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627089|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627090|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627091|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627092|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627093|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627094|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627095|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627096|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627097|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627098|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627099|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627100|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627101|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627160|NCT01069120|B1|Baseline|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
627102|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627103|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627104|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627105|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627106|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627107|NCT01068860|E10|Reported Event|Placebo in Patients With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627108|NCT01068860|E9|Reported Event|Canakinumab 150 mg in Patients With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
627109|NCT01068860|E8|Reported Event|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627110|NCT01068860|E7|Reported Event|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
627111|NCT01068860|E6|Reported Event|Placebo + Met + Sulfonyl + Thiazolidinedione|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627112|NCT01068860|E5|Reported Event|Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627113|NCT01068860|E4|Reported Event|Placebo + Metforimin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627114|NCT01068860|E3|Reported Event|Canakinumab 150 mg + Metforimin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
627115|NCT01068860|E2|Reported Event|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627116|NCT01068860|E1|Reported Event|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
627117|NCT01068912|B4|Baseline|Total|Total of all reporting groups
627118|NCT01068912|B3|Baseline|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
627119|NCT01068912|B2|Baseline|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
627120|NCT01068912|B1|Baseline|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
627121|NCT01068912|P3|Participant Flow|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
627122|NCT01068912|P2|Participant Flow|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
627123|NCT01068912|P1|Participant Flow|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
627124|NCT01068912|O3|Outcome|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
627125|NCT01068912|O2|Outcome|2: High Dose Favipiravir|Favipiravir:1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
627126|NCT01068912|O1|Outcome|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
627127|NCT01068912|E3|Reported Event|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
627131|NCT01068964|B2|Baseline|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
627132|NCT01068964|B1|Baseline|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
627133|NCT01068964|P2|Participant Flow|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
627134|NCT01068964|P1|Participant Flow|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
627135|NCT01068964|O2|Outcome|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
627136|NCT01068964|O1|Outcome|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
627137|NCT01068964|E2|Reported Event|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
627138|NCT01068964|E1|Reported Event|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
627139|NCT01069003|B4|Baseline|Total|Total of all reporting groups
627140|NCT01069003|B3|Baseline|Surveillance Arm|Non randomized subjects followed for total of 24 months
627141|NCT01069003|B2|Baseline|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)"
627142|NCT01069003|B1|Baseline|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)"
627143|NCT01069003|P3|Participant Flow|Surveillance Arm|Non randomized subjects followed for total of 24 months
627144|NCT01069003|P2|Participant Flow|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)"
627145|NCT01069003|P1|Participant Flow|Placebo|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)"
627146|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
627178|NCT01069289|P2|Participant Flow|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627179|NCT01069289|P1|Participant Flow|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627147|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)"
627148|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)"
627149|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
627150|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)"
627151|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)"
627152|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
627153|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)"
627154|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)"
627155|NCT01069003|E3|Reported Event|Surveillance Arm|Non randomized subjects followed through 24 months
627156|NCT01069003|E2|Reported Event|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)"
627157|NCT01069003|E1|Reported Event|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)"
627158|NCT01069120|B3|Baseline|Total|Total of all reporting groups
627159|NCT01069120|B2|Baseline|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
627166|NCT01069172|B1|Baseline|FS Laser Surgery and CCC Surgery|"Each eye underwent either:
Femtosecond assissisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device (the Catalys System is used for FS Laser Surgery and is an ophthalmic surgical laser system intended for use in cataract surgery).
OR
Ultrasound (U/S) cataract surgery and CCC (continuous curvilinear capsulorhexis), subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
627167|NCT01069172|P2|Participant Flow|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC)
CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
627168|NCT01069172|P1|Participant Flow|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.
FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
627169|NCT01069172|O2|Outcome|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).
CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
627170|NCT01069172|O1|Outcome|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.
FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
627171|NCT01069172|O2|Outcome|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).
CCC and U/S Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
627172|NCT01069172|O1|Outcome|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.
FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
627173|NCT01069172|E2|Reported Event|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).
CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
627174|NCT01069172|E1|Reported Event|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.
FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
627175|NCT01069289|B3|Baseline|Total|Total of all reporting groups
627176|NCT01069289|B2|Baseline|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627177|NCT01069289|B1|Baseline|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627375|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
627181|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627182|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627183|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627184|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627185|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627186|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627187|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627188|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627189|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627190|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627191|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627192|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627193|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627194|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627195|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627196|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627197|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627198|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627199|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627200|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627201|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627202|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627203|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627204|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627205|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627206|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627207|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627208|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627209|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627210|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627211|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627212|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627213|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627214|NCT01069289|E2|Reported Event|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
627215|NCT01069289|E1|Reported Event|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
627216|NCT01069341|B1|Baseline|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
627217|NCT01069341|P1|Participant Flow|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
627218|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
627219|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
627220|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
627221|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
627222|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
627223|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
627224|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
627225|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
627226|NCT01069341|E1|Reported Event|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
627227|NCT01069419|B1|Baseline|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
627228|NCT01069419|P1|Participant Flow|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
627229|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
627230|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
627231|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
627232|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
627233|NCT01069419|E1|Reported Event|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
627234|NCT01069484|B3|Baseline|Total|Total of all reporting groups
627235|NCT01069484|B2|Baseline|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention.
627236|NCT01069484|B1|Baseline|Postpartum Pelvic Floor Muscle Training|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months.
627237|NCT01069484|P2|Participant Flow|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the PFM correctly, the control group participants received no further intervention. They were not discouraged from doing PFMT on their own.
627238|NCT01069484|P1|Participant Flow|Postpartum Pelvic Floor Muscle Training|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the pelvic floor muscle (PFM) correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months. The PFM exercise protocol followed general principles for strength training; 3 sets 8-12 contractions close to maximum (Bø et al 1990, Haskell 2007). The participants are provided with a DVD of the program (www.corewellness.co.uk). Training adherence at home was recorded in a training diary whereas the physical therapist recorded group session adherence. Training participants were continuously motivated by the physical therapist to keep up their adherence to training classes and home training, and high performance during training was strongly emphasised.
627239|NCT01069484|O2|Outcome|Control|Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the control group received no further intervention..
627269|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627270|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627271|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
628129|NCT01059903|B3|Baseline|Total|Total of all reporting groups
627240|NCT01069484|O1|Outcome|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).
Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
627241|NCT01069484|O2|Outcome|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention
627242|NCT01069484|O1|Outcome|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).
Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
627243|NCT01069484|E2|Reported Event|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention
627244|NCT01069484|E1|Reported Event|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).
Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
627245|NCT01069523|B3|Baseline|Total|Total of all reporting groups
627246|NCT01069523|B2|Baseline|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
627247|NCT01069523|B1|Baseline|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
627248|NCT01069523|P2|Participant Flow|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
627249|NCT01069523|P1|Participant Flow|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
627250|NCT01069523|O2|Outcome|Guanfacine|Blinded guanfacine capsule
627251|NCT01069523|O1|Outcome|Placebo|Pill placebo
627376|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
627252|NCT01069523|O2|Outcome|Guanfacine|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
627253|NCT01069523|O1|Outcome|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
627254|NCT01069523|E2|Reported Event|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
627255|NCT01069523|E1|Reported Event|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
627256|NCT01069562|B3|Baseline|Total|Total of all reporting groups
627257|NCT01069562|B2|Baseline|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627258|NCT01069562|B1|Baseline|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627259|NCT01069562|P2|Participant Flow|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627260|NCT01069562|P1|Participant Flow|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627261|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627262|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627263|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627264|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627265|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627266|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627267|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627268|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
628172|NCT01059994|P3|Participant Flow|Sildenafil Placebo Older|Sildenafil placebo: Oral, daily, 1 week.
627272|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627273|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627274|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627275|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627276|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627277|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627278|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627279|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627280|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627281|NCT01069562|E2|Reported Event|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
627282|NCT01069562|E1|Reported Event|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
627283|NCT01069627|B1|Baseline|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627284|NCT01069627|P1|Participant Flow|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 and fotemustine 100 mg per square meter (mg/m^2) IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627377|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
627378|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
627379|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
627285|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627286|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627287|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627288|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627313|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627630|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627289|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627290|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627291|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627292|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627324|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627380|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
627293|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627294|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627295|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627296|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627297|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627399|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
627298|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627299|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627300|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627301|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627302|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627303|NCT01069627|E1|Reported Event|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.
Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.
Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.
Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
627304|NCT01069861|B1|Baseline|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627305|NCT01069861|P1|Participant Flow|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 milligram per kilogram (mg/kg) over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg per hour (mg/kg/hr) intravenous infusion up to 14 days, based on the need of individual participant.
627306|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627307|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627308|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627309|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627310|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627311|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627312|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627314|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627315|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627316|NCT01069861|E1|Reported Event|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
627317|NCT01069900|B3|Baseline|Total|Total of all reporting groups
627318|NCT01069900|B2|Baseline|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627319|NCT01069900|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627320|NCT01069900|P2|Participant Flow|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627321|NCT01069900|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627322|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627323|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627365|NCT01069939|B2|Baseline|Placebo|Placebo once daily oral
627325|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627326|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627327|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627328|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627329|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627330|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627331|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627332|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627333|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627334|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627631|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627335|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627336|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627337|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627338|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627339|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627340|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627341|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627342|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627343|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627366|NCT01069939|B1|Baseline|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
627367|NCT01069939|P2|Participant Flow|Placebo|Placebo once daily oral
627344|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627345|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627346|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627347|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627348|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627349|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627350|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627351|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627352|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627353|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627354|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627355|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627356|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627357|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627358|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627359|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627360|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627361|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
627362|NCT01069900|E2|Reported Event|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
627363|NCT01069900|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.
627364|NCT01069939|B3|Baseline|Total|Total of all reporting groups
627382|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
627383|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
627384|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
627385|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
627386|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
627387|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
627388|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
627389|NCT01069939|E2|Reported Event|Placebo|Placebo once daily oral
627390|NCT01069939|E1|Reported Event|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
627391|NCT01070043|B3|Baseline|Total|Total of all reporting groups
627392|NCT01070043|B2|Baseline|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
627393|NCT01070043|B1|Baseline|Amlodipine 5mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
627394|NCT01070043|P3|Participant Flow|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
627395|NCT01070043|P2|Participant Flow|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
627396|NCT01070043|P1|Participant Flow|Run-In Valsartan 80 mg|During run-in period, oral valsartan 80 mg once daily for 4 weeks.
627397|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
627398|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
632548|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
627400|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
627401|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
627402|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
627403|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
627404|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
627405|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
627406|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
627407|NCT01070043|E2|Reported Event|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
627408|NCT01070043|E1|Reported Event|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
627409|NCT01070173|B4|Baseline|Total|Total of all reporting groups
627410|NCT01070173|B3|Baseline|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms
627411|NCT01070173|B2|Baseline|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive)
627412|NCT01070173|B1|Baseline|Short Stature|Poor linear growth
627413|NCT01070173|P3|Participant Flow|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
627414|NCT01070173|P2|Participant Flow|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
627415|NCT01070173|P1|Participant Flow|Short Stature|Poor linear growth Group
627416|NCT01070173|O3|Outcome|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
627417|NCT01070173|O2|Outcome|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
627418|NCT01070173|O1|Outcome|Short Stature|Poor linear growth Group
627419|NCT01070173|O3|Outcome|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
627420|NCT01070173|O2|Outcome|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
627421|NCT01070173|O1|Outcome|Short Stature|Poor linear growth Group
627422|NCT01070173|E3|Reported Event|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
627423|NCT01070173|E2|Reported Event|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
627424|NCT01070173|E1|Reported Event|Short Stature|Poor linear growth Group
627425|NCT01070303|B3|Baseline|Total|Total of all reporting groups
627426|NCT01070303|B2|Baseline|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627427|NCT01070303|B1|Baseline|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627449|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627612|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
627428|NCT01070303|P1|Participant Flow|All Participants in Open-Label Extension of Study M02-433|Participants who were still receiving study drug and were evaluated at Week 56 of NCT00055497 could continue into the OLE. In the OLE, participants who received double-blind study drug (adalimumab 40 mg) during the DB portion were started on adalimumab 40 mg every other week (eow). Participants who received OL adalimumab 40 mg during the DB portion continued the dose they were receiving. Any participant who was receiving 40 mg adalimumab eow during the OLE and who experienced a disease flare (recurrence of active disease) could change to 40 mg adalimumab weekly. 176 participants were documented as completing Year 1 of the study; however, efficacy data were recorded for 177 participants at Week 56, and those participants are included in the OLE. Safety data are summarized for all participants (N = 276) who entered the study (NCT00055497).
627429|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627430|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627431|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627432|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627433|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627434|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627632|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
635350|NCT01082614|E1|Reported Event|Standard Fluid Management|
627435|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627436|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627437|NCT01070303|O4|Outcome|Change From Baseline-Week 248|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
627438|NCT01070303|O3|Outcome|Change From Baseline-Week 200|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
627439|NCT01070303|O2|Outcome|Change From Baseline-Week 152|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
627440|NCT01070303|O1|Outcome|Change From Baseline-Week 104|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
627441|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627442|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627443|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627444|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627445|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627446|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627447|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627448|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627489|NCT01070329|B2|Baseline|Placebo|Participants received placebo QD, po for 8 weeks.
636083|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
627450|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627451|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627452|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627453|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627454|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627455|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627456|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627457|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627458|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
628173|NCT01059994|P2|Participant Flow|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
627459|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627460|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627461|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627462|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627463|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627464|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627465|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627466|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627467|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627468|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627469|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627470|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627471|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627472|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627473|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
628418|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
627474|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627475|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627476|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627477|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627478|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627479|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627480|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627481|NCT01070303|E2|Reported Event|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
627482|NCT01070303|E1|Reported Event|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
627633|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627483|NCT01070316|B1|Baseline|Everolimus|"Main Study Phase:
Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.
Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day
Following the 4 week titration, subjects will continue in an 8 week maintenance period.
If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
627484|NCT01070316|P1|Participant Flow|Everolimus|"Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily.
Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day"
627485|NCT01070316|O1|Outcome|Everolimus|"Main Study Phase:
Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.
Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day
Following the 4 week titration, subjects will continue in an 8 week maintenance period.
If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
627486|NCT01070316|O1|Outcome|Everolimus|"Main Study Phase:
Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.
Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day
Following the 4 week titration, subjects will continue in an 8 week maintenance period.
If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
627487|NCT01070316|E1|Reported Event|Everolimus|"Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily.
Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day"
627488|NCT01070329|B3|Baseline|Total|Total of all reporting groups
627490|NCT01070329|B1|Baseline|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627491|NCT01070329|P2|Participant Flow|Placebo|Participants received placebo QD, po for 8 weeks.
627492|NCT01070329|P1|Participant Flow|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627493|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627494|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627495|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627496|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627497|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627498|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627499|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627500|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627501|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627502|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627503|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627634|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627504|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627505|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627506|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627507|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627508|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627509|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627510|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627511|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627512|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627513|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627514|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627515|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627516|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627517|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627518|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627519|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
627520|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627521|NCT01070329|E2|Reported Event|Placebo|Participants received placebo QD, po for 8 weeks.
627522|NCT01070329|E1|Reported Event|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
627523|NCT01058941|B3|Baseline|Total|Total of all reporting groups
627524|NCT01058941|B2|Baseline|Placebo|"placebo lipoic acid plus placebo oil
lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
627525|NCT01058941|B1|Baseline|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate
lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
627526|NCT01058941|P2|Participant Flow|Placebo|"placebo lipoic acid plus placebo oil
lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
628602|NCT01071083|O5|Outcome|Methylprednisolone|1000 mg intravenous every 4 weeks
627527|NCT01058941|P1|Participant Flow|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate
lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
627528|NCT01058941|O2|Outcome|Placebo|"placebo lipoic acid plus placebo oil
lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
627529|NCT01058941|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate
lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
627530|NCT01058941|O2|Outcome|Placebo|"placebo lipoic acid plus placebo oil
lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
627531|NCT01058941|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate
lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
627532|NCT01058941|E2|Reported Event|Placebo|"placebo lipoic acid plus placebo oil
lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
627533|NCT01058941|E1|Reported Event|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate
lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
627534|NCT01058993|B1|Baseline|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
627549|NCT01059071|O3|Outcome|Dose Level 3:1000 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 3:1000 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627535|NCT01058993|P1|Participant Flow|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
627536|NCT01058993|O1|Outcome|SINGLE Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
627537|NCT01058993|E1|Reported Event|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
627538|NCT01059071|B1|Baseline|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627539|NCT01059071|P4|Participant Flow|Dose Level 4:1500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627540|NCT01059071|P3|Participant Flow|Dose Level 3:1000 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 3:1000 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627541|NCT01059071|P2|Participant Flow|Dose Level 2: 750 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 2: 750 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
628419|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
627542|NCT01059071|P1|Participant Flow|Dose Level 1: 500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627543|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627544|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627545|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627546|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627547|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627548|NCT01059071|O4|Outcome|Dose Level 4:1500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627550|NCT01059071|O2|Outcome|Dose Level 2: 750 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 2: 750 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627551|NCT01059071|O1|Outcome|Dose Level 1: 500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627552|NCT01059071|E1|Reported Event|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
627553|NCT01059175|B3|Baseline|Total|Total of all reporting groups
627554|NCT01059175|B2|Baseline|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627555|NCT01059175|B1|Baseline|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627556|NCT01059175|P2|Participant Flow|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627557|NCT01059175|P1|Participant Flow|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627558|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627559|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627560|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627579|NCT01059305|P1|Participant Flow|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
627613|NCT01059526|E1|Reported Event|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
627561|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627562|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627563|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627564|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627565|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627566|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627567|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627568|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627628|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627910|NCT01059760|O1|Outcome|Baseline Value|
627911|NCT01059760|O3|Outcome|Change When Fed|
627569|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627570|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627571|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627572|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627573|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627574|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627575|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627576|NCT01059175|E2|Reported Event|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627577|NCT01059175|E1|Reported Event|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
627578|NCT01059305|B1|Baseline|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
627580|NCT01059305|O1|Outcome|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
627581|NCT01059305|E1|Reported Event|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
627582|NCT01059344|B3|Baseline|Total|Total of all reporting groups
627583|NCT01059344|B2|Baseline|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
627584|NCT01059344|B1|Baseline|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
627585|NCT01059344|P2|Participant Flow|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
627586|NCT01059344|P1|Participant Flow|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
627587|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
627588|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
627589|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
627590|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
627591|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
627592|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
627629|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627593|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
627594|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
627595|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
627596|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
627597|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
627598|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
627599|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
627600|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
627601|NCT01059344|E2|Reported Event|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
627602|NCT01059344|E1|Reported Event|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
627603|NCT01059526|B3|Baseline|Total|Total of all reporting groups
627604|NCT01059526|B2|Baseline|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study
ecallantide: 30 mg SC"
627605|NCT01059526|B1|Baseline|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study
ecallantide: 30 mg SC"
627606|NCT01059526|P2|Participant Flow|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study
ecallantide: 30 mg SC"
627607|NCT01059526|P1|Participant Flow|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study
ecallantide: 30 mg SC"
627608|NCT01059526|O2|Outcome|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study
ecallantide: 30 mg SC"
627609|NCT01059526|O1|Outcome|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study
ecallantide: 30 mg SC"
627610|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
627611|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
627615|NCT01059565|B2|Baseline|Placebo|Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627616|NCT01059565|B1|Baseline|AZLI|Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627617|NCT01059565|P2|Participant Flow|Placebo|Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants switched to AZLI during the open-label phase.
627618|NCT01059565|P1|Participant Flow|AZLI|Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants continued to receive AZLI during the open-label phase.
627619|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627620|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627621|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627622|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627623|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627624|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627625|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627626|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627627|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627912|NCT01059760|O2|Outcome|Change While Fasting|
627635|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627636|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627637|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627638|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627639|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627640|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627641|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627642|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627643|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627644|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627645|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627646|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
627647|NCT01059565|E4|Reported Event|Placebo/AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline and switched AZLI for up to 24 weeks of treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
627648|NCT01059565|E3|Reported Event|AZLI/AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline and continued to receive an up to an additional 24 weeks of AZLI treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
627649|NCT01059565|E2|Reported Event|Placebo|For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline, and were analyzed from Baseline to Week 24.
627650|NCT01059565|E1|Reported Event|AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline, and were analyzed from Baseline to Week 24.
627651|NCT01059617|B5|Baseline|Total|Total of all reporting groups
627652|NCT01059617|B4|Baseline|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627653|NCT01059617|B3|Baseline|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627654|NCT01059617|B2|Baseline|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
628420|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
627655|NCT01059617|B1|Baseline|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627656|NCT01059617|P4|Participant Flow|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627657|NCT01059617|P3|Participant Flow|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627658|NCT01059617|P2|Participant Flow|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627659|NCT01059617|P1|Participant Flow|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627660|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627661|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627662|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627663|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627913|NCT01059760|O1|Outcome|Baseline Value|
627914|NCT01059760|O3|Outcome|Change When Fed|
627915|NCT01059760|O2|Outcome|Change While Fasting|
627664|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627665|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627666|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627667|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627668|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
627669|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
627670|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
627671|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
627672|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627673|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627674|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627675|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627676|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627677|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627678|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627679|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627680|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
627681|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
627682|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
627683|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
627684|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627685|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627686|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627687|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627688|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627689|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627690|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627916|NCT01059760|O1|Outcome|Baseline Value|
627917|NCT01059760|O3|Outcome|Change When Fed|
627918|NCT01059760|O2|Outcome|Change While Fasting|
627691|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627692|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627693|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627694|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627695|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627696|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627697|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627698|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627699|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627700|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627701|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627702|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627703|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627704|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627705|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627706|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627707|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627708|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
627709|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
627710|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
627711|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
627712|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627713|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627714|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627715|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627716|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627717|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627718|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627719|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627720|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627721|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627722|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627723|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627724|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627725|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627726|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627727|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627728|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627729|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627730|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627731|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627732|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
627733|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
627734|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627735|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627736|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627737|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627738|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627739|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627740|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627741|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627742|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627743|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day143.
627744|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627745|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm a t Days 0 and 122 and of the dominant arm at Day143.
627746|NCT01059617|O2|Outcome|Placebo Group|Subjects received a saline placebo on Day 0 and either adjuvanted or unadjuvanted formulation of Arepanrix on Days 122 and 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627747|NCT01059617|O1|Outcome|Flulaval Group|Subjects received Flulaval vaccine on Day 0 and either adjuvanted or unadjuvanted formulation of Arepanrix on Days 122 and 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627748|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627749|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627750|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627751|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627752|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627753|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627754|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627755|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627756|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627757|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627758|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627759|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627760|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627761|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627762|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627763|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627764|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627919|NCT01059760|O1|Outcome|Baseline Value|
627920|NCT01059760|O3|Outcome|Change When Fed|
627921|NCT01059760|O2|Outcome|Change While Fasting|
627765|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627766|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627767|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627768|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627769|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627770|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627771|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627772|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627773|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627774|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627775|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627776|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627777|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627778|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627779|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627780|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627781|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627782|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627783|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627784|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627785|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627786|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627787|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627788|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627789|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627790|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627791|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627792|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627793|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627794|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627795|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627796|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627797|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627798|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627799|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627800|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627801|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627802|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627803|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627804|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627805|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627806|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627807|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627808|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627809|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627810|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627811|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627812|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627813|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627814|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627815|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627816|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627817|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627818|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627819|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627820|NCT01059617|E6|Reported Event|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
627821|NCT01059617|E5|Reported Event|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
627822|NCT01059617|E4|Reported Event|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627823|NCT01059617|E3|Reported Event|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627824|NCT01059617|E2|Reported Event|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627825|NCT01059617|E1|Reported Event|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
627826|NCT01059630|B3|Baseline|Total|Total of all reporting groups
627862|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
628009|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
628783|NCT01072006|E3|Reported Event|TBI Group|TBI (no PTSD)
627827|NCT01059630|B2|Baseline|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627828|NCT01059630|B1|Baseline|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627829|NCT01059630|P2|Participant Flow|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with complete response (CR), partial response (PR) or stable disease (SD) then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627830|NCT01059630|P1|Participant Flow|Bendamustine Alone|Participants received Bendamustine 120 milligrams per meter square (mg/m^2) Intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627831|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627832|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627833|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627834|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627922|NCT01059760|O1|Outcome|Baseline Value|
627923|NCT01059760|O3|Outcome|Change When Fed|
627924|NCT01059760|O2|Outcome|Change While Fasting|
627925|NCT01059760|O1|Outcome|Baseline Value|
627926|NCT01059760|O3|Outcome|Change When Fed|
627927|NCT01059760|O2|Outcome|Change While Fasting|
627835|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627836|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627837|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627838|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627839|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627840|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627841|NCT01059630|O1|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627842|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627843|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
628421|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
627844|NCT01059630|O1|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627845|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627846|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627847|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627848|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627849|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627850|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627851|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627852|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627928|NCT01059760|O1|Outcome|Baseline Value|
627853|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627854|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627855|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627856|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627857|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627858|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627859|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627860|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627861|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627863|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627864|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627865|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627866|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627867|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627868|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627869|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627870|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627929|NCT01059760|O3|Outcome|Change When Fed|
627930|NCT01059760|O2|Outcome|Change While Fasting|
627931|NCT01059760|O1|Outcome|Baseline Value|
627932|NCT01059760|O3|Outcome|Change When Fed|
627933|NCT01059760|O2|Outcome|Change While Fasting|
627934|NCT01059760|O1|Outcome|Baseline Value|
627935|NCT01059760|O3|Outcome|Change When Fed|
627871|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627872|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627873|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627874|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627875|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627876|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627877|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627878|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627879|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627880|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627881|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627882|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627883|NCT01059630|E2|Reported Event|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
627884|NCT01059630|E1|Reported Event|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
627885|NCT01059760|B3|Baseline|Total|Total of all reporting groups
627886|NCT01059760|B2|Baseline|Fed Day First|28± 4 hours fed followed by 28± 4 hours of fasting
627887|NCT01059760|B1|Baseline|Fasting Day First|28±4 hours of water-only fasting followed by 28±4 hours fed
627888|NCT01059760|P2|Participant Flow|Fed Day First|28± 4 hours fed followed by 28± 4 hours of fasting
627889|NCT01059760|P1|Participant Flow|Fasting Day First|28±4 hours of water-only fasting followed by 28±4 hours fed
627890|NCT01059760|O3|Outcome|Change When Fed|
627891|NCT01059760|O2|Outcome|Change While Fasting|
627892|NCT01059760|O1|Outcome|Baseline Value|
627893|NCT01059760|O3|Outcome|Change When Fed|
627894|NCT01059760|O2|Outcome|Change While Fasting|
627895|NCT01059760|O1|Outcome|Baseline Value|
627896|NCT01059760|O3|Outcome|Change When Fed|
627897|NCT01059760|O2|Outcome|Change While Fasting|
627898|NCT01059760|O1|Outcome|Baseline Value|
627899|NCT01059760|O3|Outcome|Change When Fed|
627900|NCT01059760|O2|Outcome|Change While Fasting|
627901|NCT01059760|O1|Outcome|Baseline Value|
627902|NCT01059760|O3|Outcome|Change When Fed|
627903|NCT01059760|O2|Outcome|Change While Fasting|
627904|NCT01059760|O1|Outcome|Baseline Value|
627905|NCT01059760|O3|Outcome|Change When Fed|
627906|NCT01059760|O2|Outcome|Change While Fasting|
627907|NCT01059760|O1|Outcome|Baseline Value|
627908|NCT01059760|O3|Outcome|Change When Fed|
627909|NCT01059760|O2|Outcome|Change While Fasting|
627995|NCT01059773|B2|Baseline|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
627996|NCT01059773|B1|Baseline|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
627997|NCT01059773|P2|Participant Flow|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
627998|NCT01059773|P1|Participant Flow|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
627999|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
628000|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
628001|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
628002|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
628003|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
628004|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
628005|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
628006|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
628007|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
628008|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
628010|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
628011|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
628012|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
628013|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
628014|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
628015|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
628016|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
628017|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
628018|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
628019|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
628020|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
628021|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
628022|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
628023|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
628024|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
628025|NCT01059773|E2|Reported Event|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
628026|NCT01059773|E1|Reported Event|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
628027|NCT01059799|B3|Baseline|Total|Total of all reporting groups
628028|NCT01059799|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628029|NCT01059799|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628030|NCT01059799|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628031|NCT01059799|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628032|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628033|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628034|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628035|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628036|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628037|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628784|NCT01072006|E2|Reported Event|PTSD Group|PTSD (not TBI)
628038|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628039|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628040|NCT01059799|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628041|NCT01059799|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
628042|NCT01059812|B3|Baseline|Total|Total of all reporting groups
628043|NCT01059812|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628044|NCT01059812|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628045|NCT01059812|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628046|NCT01059812|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628047|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628048|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628049|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628050|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628051|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628052|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628053|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628054|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
635351|NCT01082640|B4|Baseline|Total|Total of all reporting groups
628055|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628056|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628057|NCT01059812|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628058|NCT01059812|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
628059|NCT01059851|B3|Baseline|Total|Total of all reporting groups
628060|NCT01059851|B2|Baseline|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
628061|NCT01059851|B1|Baseline|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant."
628062|NCT01059851|P6|Participant Flow|Healthy Participants (Mild Impairment Controls) (Part II)|Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
628063|NCT01059851|P5|Participant Flow|Participants With Mild Renal Impairment (Part II)|Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
628064|NCT01059851|P4|Participant Flow|Healthy Participants (Moderate Impairment Controls) (Part II)|Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
628065|NCT01059851|P3|Participant Flow|Participants With Moderate Renal Impairment (Part II)|Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
628066|NCT01059851|P2|Participant Flow|Healthy Participants (Severe Impairment Controls) (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
628067|NCT01059851|P1|Participant Flow|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant."
628068|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
628069|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant."
628070|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
628071|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant."
628072|NCT01059851|O4|Outcome|Healthy Participants (Mild Impairment Controls) (Part II)|Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
628594|NCT01071083|B3|Baseline|Interferon β-1a|30 ug intramuscular once per week
628073|NCT01059851|O3|Outcome|Participants With Mild Renal Impairment (Part II)|Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
628074|NCT01059851|O2|Outcome|Healthy Participants (Moderate Impairment Controls) (Part II)|Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
628075|NCT01059851|O1|Outcome|Participants With Moderate Renal Impairment (Part II)|Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
628076|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
628077|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant."
628078|NCT01059851|E2|Reported Event|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
628079|NCT01059851|E1|Reported Event|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a
single dose of 20 mg open-label suvorexant."
628080|NCT01059864|B1|Baseline|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
628081|NCT01059864|P3|Participant Flow|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628082|NCT01059864|P2|Participant Flow|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628083|NCT01059864|P1|Participant Flow|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
628084|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628085|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628174|NCT01059994|P1|Participant Flow|Sildenafil Placebo Young|Sildenafil placebo: Oral, daily, 1 week.
628086|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628087|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628088|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628089|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628090|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628091|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628092|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628093|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628094|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628095|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628096|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628149|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628097|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628098|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628099|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628100|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628101|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628102|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628103|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628104|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628105|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628106|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628175|NCT01059994|O4|Outcome|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
628176|NCT01059994|O3|Outcome|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
628107|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628108|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628109|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628110|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628111|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628112|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628113|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628114|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628115|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628116|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628117|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628118|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628119|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628120|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628121|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628122|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628123|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628124|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628125|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628126|NCT01059864|E3|Reported Event|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628127|NCT01059864|E2|Reported Event|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
628128|NCT01059864|E1|Reported Event|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
628130|NCT01059903|B2|Baseline|Rotigotine PR2.1.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
628131|NCT01059903|B1|Baseline|Rotigotine PR2.2.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
628132|NCT01059903|P2|Participant Flow|Rotigotine PR2.1.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
628133|NCT01059903|P1|Participant Flow|Rotigotine PR2.2.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
628134|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628135|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628136|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628137|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628138|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628139|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628140|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628141|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628142|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628143|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628144|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628145|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628146|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628147|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628148|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628150|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628151|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628152|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628153|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628154|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628155|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628156|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628157|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628158|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628159|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628160|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628161|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628162|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628163|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628164|NCT01059903|E2|Reported Event|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
628165|NCT01059903|E1|Reported Event|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
628166|NCT01059994|B5|Baseline|Total|Total of all reporting groups
628167|NCT01059994|B4|Baseline|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
628168|NCT01059994|B3|Baseline|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
628169|NCT01059994|B2|Baseline|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
628170|NCT01059994|B1|Baseline|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
628171|NCT01059994|P4|Participant Flow|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
628177|NCT01059994|O2|Outcome|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
628178|NCT01059994|O1|Outcome|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
628179|NCT01059994|O4|Outcome|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
628180|NCT01059994|O3|Outcome|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
628181|NCT01059994|O2|Outcome|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
628182|NCT01059994|O1|Outcome|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
628183|NCT01059994|E4|Reported Event|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
628184|NCT01059994|E3|Reported Event|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
628185|NCT01059994|E2|Reported Event|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
628186|NCT01059994|E1|Reported Event|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
628187|NCT01060007|B1|Baseline|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
628188|NCT01060007|P1|Participant Flow|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
628189|NCT01060007|O3|Outcome|1 Year Post-treatment|
628190|NCT01060007|O2|Outcome|Pre-surgery|
628191|NCT01060007|O1|Outcome|Pre-treatment|
628192|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
628193|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
628219|NCT01070550|B7|Baseline|Total|Total of all reporting groups
628220|NCT01070550|B6|Baseline|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628194|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
628195|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
628196|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
628197|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
628198|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
628199|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
628200|NCT01060007|E1|Reported Event|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
639153|NCT01098812|O2|Outcome|Toric IOL|Investigational Toric IOL
628201|NCT01070381|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects
628202|NCT01070381|P2|Participant Flow|Ocufilcon D / Nelfilcon A|Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
628203|NCT01070381|P1|Participant Flow|Nelfilcon A / Ocufilcon D|Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
628204|NCT01070381|O2|Outcome|Ocufilcon D|Commercially marketed, toric, soft contact lens for daily disposable wear
628205|NCT01070381|O1|Outcome|Nelfilcon A|Commercially marketed, toric, soft contact lens for daily disposable wear
628206|NCT01070381|E2|Reported Event|Ocufilcon D|Commercially marketed, toric, soft contact lens for daily disposable wear
628207|NCT01070381|E1|Reported Event|Nelfilcon A|Commercially marketed, toric, soft contact lens for daily disposable wear
628208|NCT01070394|B1|Baseline|LDX Treatment|Prospective participants will be evaluated for ADHD and study inclusion/exclusion criteria. Eligible participants will begin open-label lisdexamfetamine dimesylate for 12 weeks. Those who were able to complete all 12 weeks of the treatment were evaluated for data purposes.
628209|NCT01070394|P1|Participant Flow|Overall Study: Lisdexamfetamine Treatment|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
628210|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
628221|NCT01070550|B5|Baseline|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628211|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
628212|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
628213|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
628214|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
628235|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628236|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628237|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628215|NCT01070394|O1|Outcome|Treatment Arm|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
628216|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
628217|NCT01070394|O1|Outcome|Overall Study|"Eligible participants received 12 weeks of open-label treatment. Those on treatment prior to baseline underwent a 7-day (for amphetamine or methylphenidate) or 28-day (for atomoxetine or other medications) washout period prior to initiating LDX treatment. The starting dose was 30mg/day, which could be titrated up by 20mg/day during visits 2-6 (for a maximum dose of 70mg/day). At discretion of investigator, the dose could be down-titrated by 20mg/day during visits 4-6. Once the dose was optimized (after visit 6), the dose was maintained for 8 weeks.
LDX Treatment: 30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks."
628218|NCT01070394|E1|Reported Event|LDX Treatment|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
628222|NCT01070550|B4|Baseline|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628223|NCT01070550|B3|Baseline|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628224|NCT01070550|B2|Baseline|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628225|NCT01070550|B1|Baseline|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628226|NCT01070550|P6|Participant Flow|Genotype Unknown|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628227|NCT01070550|P5|Participant Flow|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628228|NCT01070550|P4|Participant Flow|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
628229|NCT01070550|P3|Participant Flow|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
628230|NCT01070550|P2|Participant Flow|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labelling were observed for up to 72 weeks.
628231|NCT01070550|P1|Participant Flow|Genotype 1|Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received PEGASYS® (Pegylated Interferon [PEG-IFN]) alfa-2a plus ribavirin according to the standard of care and in line with summary of product characteristics (SPCs)/local labelling were observed for up to 72 weeks.
628232|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628233|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628234|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
639827|NCT01092442|O2|Outcome|Prospective Ross|
628238|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628239|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628240|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628241|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628242|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628243|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628244|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628245|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628246|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628247|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628248|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628249|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628250|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628251|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628417|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628252|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628253|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628254|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628255|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628256|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628257|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628258|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628259|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628260|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628261|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628262|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628263|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628264|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628265|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628387|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628266|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628267|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628268|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628269|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628270|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628271|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628272|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628273|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628274|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628275|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628276|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628277|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628278|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628279|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628280|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628281|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628282|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628283|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628284|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628285|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628286|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628287|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628288|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628289|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628290|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628291|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628292|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628293|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628388|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628294|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628295|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628296|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628297|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628298|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628299|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628300|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628301|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628302|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628303|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628304|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628305|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628306|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628307|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628308|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628309|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628310|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628311|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628312|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628313|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628314|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628315|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628316|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628317|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628318|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628319|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628320|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628321|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628389|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628322|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628323|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628324|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628325|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628326|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628327|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628328|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628329|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628330|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628331|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628332|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628333|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628334|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628335|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628336|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628337|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628338|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628339|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628340|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628341|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628342|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628343|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628344|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628345|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628346|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628347|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628348|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628349|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628390|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628350|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628351|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628352|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628353|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628354|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628355|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628356|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628357|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628358|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628359|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628360|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628361|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628362|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628363|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received Peginterferon (PEG-IFN) alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628364|NCT01070550|E6|Reported Event|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628365|NCT01070550|E5|Reported Event|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628366|NCT01070550|E4|Reported Event|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628367|NCT01070550|E3|Reported Event|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628368|NCT01070550|E2|Reported Event|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628369|NCT01070550|E1|Reported Event|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
628370|NCT01070771|B1|Baseline|Radi Pressure Wire|
628371|NCT01070771|P1|Participant Flow|Radi Pressure Wire|Assessment of physiological significance of coronary artery narrowings by measurement of blood flow limitation across lesion.
628372|NCT01070771|O1|Outcome|RADI Pressure Wire|
628373|NCT01070771|O1|Outcome|Radi Pressure Wire|
628374|NCT01070771|E1|Reported Event|RADI Pressure Wire|
628375|NCT01070784|B3|Baseline|Total|Total of all reporting groups
628376|NCT01070784|B2|Baseline|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628377|NCT01070784|B1|Baseline|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628378|NCT01070784|P2|Participant Flow|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628379|NCT01070784|P1|Participant Flow|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628380|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628381|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628382|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628383|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628384|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628385|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628386|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628391|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628392|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628393|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628394|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628395|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628396|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628397|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628398|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628399|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628400|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628401|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628402|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628403|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628404|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628405|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628406|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628407|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628408|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628409|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628410|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628411|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628412|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628413|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628414|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628415|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628416|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628422|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628423|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628424|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628425|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628426|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628427|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628428|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628429|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628430|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628431|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628432|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628433|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628434|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628435|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628436|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628437|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628438|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628439|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628440|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628441|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628442|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628443|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628444|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628445|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628446|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628447|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628448|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628449|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628450|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628451|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628452|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628453|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628454|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628455|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628456|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628457|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628458|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628459|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628460|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628461|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628462|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628463|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628464|NCT01070784|E2|Reported Event|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
628465|NCT01070784|E1|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
628466|NCT01070810|B3|Baseline|Total|Total of all reporting groups
628467|NCT01070810|B2|Baseline|Thiamine|200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5%
628468|NCT01070810|B1|Baseline|Placebo|50 ml D5W D5W: Dextrose 5%
628469|NCT01070810|P2|Participant Flow|Thiamine|"200mg Thiamine in 50ml D5W
Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
628470|NCT01070810|P1|Participant Flow|Placebo|"50 ml D5W
D5W: Dextrose 5%"
628471|NCT01070810|O2|Outcome|Thiamine Deficient, Received Placebo|Thiamine deficient (≤ 7 nmol/L) received 50ml D5W
628472|NCT01070810|O1|Outcome|Thiamine Deficient Received Thiamine|Thiamine deficient (≤ 7 nmol/L) received 200mg Thiamine in 50ml D5W
628473|NCT01070810|O2|Outcome|Thiamine Deficient, Received Placebo|Thiamine deficient (≤ 7 nmol/L) received 50ml D5W
628474|NCT01070810|O1|Outcome|Thiamine Deficient Received Thiamine|Thiamine deficient (≤ 7 nmol/L) received 200mg Thiamine in 50ml D5W
636084|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
628475|NCT01070810|O2|Outcome|Thiamine|"200mg Thiamine in 50ml D5W
Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
628476|NCT01070810|O1|Outcome|Placebo|"50 ml D5W
D5W: Dextrose 5%"
628477|NCT01070810|O2|Outcome|Thiamine|"200mg Thiamine in 50ml D5W
Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
628478|NCT01070810|O1|Outcome|Placebo|"50 ml D5W
D5W: Dextrose 5%"
628479|NCT01070810|O2|Outcome|Thiamine|"200mg Thiamine in 50ml D5W
Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
628480|NCT01070810|O1|Outcome|Placebo|"50 ml D5W
D5W: Dextrose 5%"
628481|NCT01070810|E2|Reported Event|Thiamine|200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5%
628482|NCT01070810|E1|Reported Event|Placebo|50 ml D5W D5W: Dextrose 5%
628483|NCT01070888|B3|Baseline|Total|Total of all reporting groups
628484|NCT01070888|B2|Baseline|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.
Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks,"
628485|NCT01070888|B1|Baseline|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.
Budesonide first: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
628486|NCT01070888|P2|Participant Flow|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide and dummy inhale, 2 inhalations of each, twice daily.
Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
628487|NCT01070888|P1|Participant Flow|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide/formoterol and dummy inhale, 2 inhalations of each, twice daily.
Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
628488|NCT01070888|O2|Outcome|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily, then in the subsequent period take budesonide and dummy inhaler 2 puffs twice daily.
Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
628532|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
628533|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
628489|NCT01070888|O1|Outcome|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Then in the subsequent study period take budesonide/formoterol plus dummy inhaler 2 inhalations of each inhaler, twice daily
Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
628490|NCT01070888|E2|Reported Event|Budesonide|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.
Budesonide: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/formoterol 180mcg, 2 puffs twice daily for 2 weeks"
628491|NCT01070888|E1|Reported Event|Budesonide/Formoterol|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.
Budesonide/Formoterol: Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
628492|NCT01070953|B1|Baseline|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
628493|NCT01070953|P1|Participant Flow|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
628494|NCT01070953|O1|Outcome|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
628495|NCT01070953|O1|Outcome|All Participants|
628496|NCT01070953|O1|Outcome|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
628497|NCT01070953|E6|Reported Event|EZETROL Year 6|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 6.
628498|NCT01070953|E5|Reported Event|EZETROL Year 5|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 5.
628499|NCT01070953|E4|Reported Event|EZETROL Year 4|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 4.
628500|NCT01070953|E3|Reported Event|EZETROL Year 3|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 3.
628501|NCT01070953|E2|Reported Event|EZETROL Year 2|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 2.
628502|NCT01070953|E1|Reported Event|EZETROL Year 1|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 1.
628503|NCT01070966|B1|Baseline|VYTORIN® 10/10 mg/Day to 10/80 mg/Day|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
628504|NCT01070966|P1|Participant Flow|VYTORIN® 10/10 mg/Day to 10/80 mg/Day|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)treated with VYTORIN® dosages ranging from 10/10(ezetimibe 10 mg/simvastatin 10 mg tablets)a day to 10/80(ezetimibe 10 mg/simvastatin 80 mg tablets)a day.
628505|NCT01070966|O3|Outcome|Participants Percent Change|
628506|NCT01070966|O2|Outcome|Participants Treatment Lipid Parameters|Participants treatment lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
628507|NCT01070966|O1|Outcome|Participants Baseline Lipid Parameters|Participants baseline lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
628508|NCT01070966|O1|Outcome|Participants Treated With VYTORIN|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
628509|NCT01070966|E5|Reported Event|VYTORIN YEAR 6|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 6
628510|NCT01070966|E4|Reported Event|VYTORIN YEAR 5|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 5
628511|NCT01070966|E3|Reported Event|VYTORIN YEAR 4|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 4
628512|NCT01070966|E2|Reported Event|VYTORIN YEAR 2|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 2
628513|NCT01070966|E1|Reported Event|VYTORIN YEAR 1|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 1
628514|NCT01070979|B4|Baseline|Total|Total of all reporting groups
628515|NCT01070979|B3|Baseline|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
628516|NCT01070979|B2|Baseline|Estradiol|1 tablet daily containing 1 mg estradiol
628517|NCT01070979|B1|Baseline|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
628518|NCT01070979|P3|Participant Flow|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
628519|NCT01070979|P2|Participant Flow|Estradiol|1 tablet daily containing 1 mg estradiol
628520|NCT01070979|P1|Participant Flow|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
628521|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
628522|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
628523|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
628524|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
628525|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
628526|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
628527|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
628528|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
628529|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
628530|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
628531|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
628534|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
628535|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
628536|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
628537|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
628538|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
628539|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
628540|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
628541|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
628542|NCT01070979|E3|Reported Event|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
628543|NCT01070979|E2|Reported Event|Estradiol|1 tablet daily containing 1 mg estradiol
628544|NCT01070979|E1|Reported Event|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
628545|NCT01071044|B3|Baseline|Total|Total of all reporting groups
628546|NCT01071044|B2|Baseline|Sugar Pill|Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
628547|NCT01071044|B1|Baseline|Lisdexamfetamine Dimesylate|"Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo)."
628548|NCT01071044|P2|Participant Flow|Sugar Pill|Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
628595|NCT01071083|B2|Baseline|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
628596|NCT01071083|B1|Baseline|Natalizumab|300 mg intravenous every 4 weeks
628597|NCT01071083|P5|Participant Flow|Methylprednisolone|1000 mg intravenous every 4 weeks
628598|NCT01071083|P4|Participant Flow|Glatiramer Acetate|20 mg subcutaneous once daily
628599|NCT01071083|P3|Participant Flow|Interferon β-1a|30 ug intramuscular once per week
628600|NCT01071083|P2|Participant Flow|Natalizumab|300 mg intravenous every 4 weeks
628601|NCT01071083|P1|Participant Flow|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
628549|NCT01071044|P1|Participant Flow|Lisdexamfetamine Dimesylate|"Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo)."
628550|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
628551|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
628552|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
628553|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate, 30, 50 or 70 mg
628554|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
628555|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
628556|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50, or 70mg"
628557|NCT01071044|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate 30, 50, 70 mg
628558|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
628559|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
628560|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
628561|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
628562|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
628563|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
628564|NCT01071044|E2|Reported Event|Control Group|"Placebo 30, 50 or 70 mg"
628565|NCT01071044|E1|Reported Event|Treatment Group|Lisdexamfetamine Dimesylate 30, 50, or 70 mg
628566|NCT01071070|B3|Baseline|Total|Total of all reporting groups
628567|NCT01071070|B2|Baseline|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628568|NCT01071070|B1|Baseline|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628569|NCT01071070|P2|Participant Flow|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628570|NCT01071070|P1|Participant Flow|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628571|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628572|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628573|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628574|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628575|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628576|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628577|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628578|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628579|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628580|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628581|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628582|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628583|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628584|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628585|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628586|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628587|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628588|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628589|NCT01071070|E2|Reported Event|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
628590|NCT01071070|E1|Reported Event|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
628591|NCT01071083|B6|Baseline|Total|Total of all reporting groups
628592|NCT01071083|B5|Baseline|Methylprednisolone|1000 mg intravenous every 4 weeks
628593|NCT01071083|B4|Baseline|Glatiramer Acetate|20 mg subcutaneous once daily
628603|NCT01071083|O4|Outcome|Glatiramer Acetate|20 mg subcutaneous once daily
628604|NCT01071083|O3|Outcome|Interferon β-1a|30 ug intramuscular once per week
628605|NCT01071083|O2|Outcome|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
628606|NCT01071083|O1|Outcome|Natalizumab|300 mg intravenous every 4 weeks
628607|NCT01071083|O5|Outcome|Methylprednisolone|1000 mg intravenous every 4 weeks
628608|NCT01071083|O4|Outcome|Glatiramer Acetate|20 mg subcutaneous once daily
628609|NCT01071083|O3|Outcome|Interferon β-1a|30 ug intramuscular once per week
628610|NCT01071083|O2|Outcome|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
628611|NCT01071083|O1|Outcome|Natalizumab|300 mg intravenous every 4 weeks
628612|NCT01071083|E5|Reported Event|Methylprednisolone|1000 mg intravenous every 4 weeks
628613|NCT01071083|E4|Reported Event|Glatiramer Acetate|20 mg subcutaneous once daily
628614|NCT01071083|E3|Reported Event|Interferon β-1a|30 ug intramuscular once per week
628615|NCT01071083|E2|Reported Event|Natalizumab|300 mg intravenous every 4 weeks
628616|NCT01071083|E1|Reported Event|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
628617|NCT01071096|B1|Baseline|Enrolled Participants|Enrolled Participants includes subjects in both Group A (treated with BOTOX and Visit 1 and Placebo at Visit 5) and Group B (treated with Placebo at Visit 1 and BOTOX at Visit 5).
628618|NCT01071096|P2|Participant Flow|Group B|Subjects were injected with Saline at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with OnabotulinumtoxinA at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
628619|NCT01071096|P1|Participant Flow|Group A|Subjects were injected with OnabotulinumtoxinA at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with Saline at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
628620|NCT01071096|O6|Outcome|Month 1 vs. Month 3 Non-Responders|Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with <30% reduction in number of headache days per month from baseline.
628621|NCT01071096|O5|Outcome|Month 1 vs. Month 3 Responders|Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with >30% reduction in number of headache days per month from baseline.
628622|NCT01071096|O4|Outcome|Month 3 vs. Saline Non-Responders|Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
628623|NCT01071096|O3|Outcome|Month 3 vs. Saline Responders|Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
628624|NCT01071096|O2|Outcome|Month 1 vs. Saline Non-Responders|Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
628625|NCT01071096|O1|Outcome|Month 1 vs. Saline Responders|Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
628626|NCT01071096|O3|Outcome|Saline|This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
628627|NCT01071096|O2|Outcome|OnabotulinumtoxinA Non-Responders|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with <30% reduction in number of headache days per month when compared to Baseline
628628|NCT01071096|O1|Outcome|OnabotulinumtoxinA Responders|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with >30% reduction in number of headache days per month when compared to Baseline
628629|NCT01071096|O2|Outcome|Saline|This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
628630|NCT01071096|O1|Outcome|OnabotulinumtoxinA|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7).
628631|NCT01071096|O2|Outcome|Group B|Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
628632|NCT01071096|O1|Outcome|Group A|OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
628633|NCT01071096|O2|Outcome|Group B|Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
628634|NCT01071096|O1|Outcome|Group A|OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
628635|NCT01071096|E2|Reported Event|OnabotulinumtoxinA|Subjects injected with onabotulinumtoxinA in Group A at Visit 1 (Day 1) and Group B at Visit 5 (Day 151)
628636|NCT01071096|E1|Reported Event|Saline|Subjects injected with Saline in Group A at Visit 5 (Day 151) and Group B at Visit 1 (Day 1)
628637|NCT01071200|B3|Baseline|Total|Total of all reporting groups
628638|NCT01071200|B2|Baseline|Follicle-stimulating Hormone (FSH)|FSH injection s.c. administered according to investigator’s discretion till r-hCG administration day.
628639|NCT01071200|B1|Baseline|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628640|NCT01071200|P2|Participant Flow|Follicle-stimulating Hormone (FSH)|FSH injection s.c. administered according to investigator’s discretion till r-hCG administration day.
628641|NCT01071200|P1|Participant Flow|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628642|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628643|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628644|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628645|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628646|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628647|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628648|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628649|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628650|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628651|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628652|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628653|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628654|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628655|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628656|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628657|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628658|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628659|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628660|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628661|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628662|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628663|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628664|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628665|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628666|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628667|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628668|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628669|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628670|NCT01071200|E2|Reported Event|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
628671|NCT01071200|E1|Reported Event|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
628672|NCT01071252|B6|Baseline|Total|Total of all reporting groups
628673|NCT01071252|B5|Baseline|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628674|NCT01071252|B4|Baseline|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628675|NCT01071252|B3|Baseline|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628676|NCT01071252|B2|Baseline|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628677|NCT01071252|B1|Baseline|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
628678|NCT01071252|P5|Participant Flow|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628679|NCT01071252|P4|Participant Flow|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628680|NCT01071252|P3|Participant Flow|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628681|NCT01071252|P2|Participant Flow|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628682|NCT01071252|P1|Participant Flow|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
628683|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628684|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628685|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628686|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
628687|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628688|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628689|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628690|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628691|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
628692|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628693|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628694|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628695|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628696|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
628697|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628698|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628699|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628700|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628701|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
628702|NCT01071252|E5|Reported Event|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628703|NCT01071252|E4|Reported Event|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628704|NCT01071252|E3|Reported Event|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628705|NCT01071252|E2|Reported Event|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
628706|NCT01071252|E1|Reported Event|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
628707|NCT01071278|B1|Baseline|Intent-to-Treat Population|Baseline characteristics were reported for the 2359 participants in the Intent-to-Treat (ITT) Population, which included all participants from the Evaluable Population who began therapy at or after Visit 1. The ITT Population excluded 31 of the 2390 evaluable participants who began treatment prior to Visit 1.
628708|NCT01071278|P1|Participant Flow|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
628709|NCT01071278|O1|Outcome|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
628710|NCT01071278|O2|Outcome|Patients Treated Outside a Disease Management Program|Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
628711|NCT01071278|O1|Outcome|Patients Treated Within a Disease Management Program|Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
628712|NCT01071278|E1|Reported Event|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
628713|NCT01071395|B3|Baseline|Total|Total of all reporting groups
628714|NCT01071395|B2|Baseline|Placebo|Placebo: Sugar pill given 3 times daily
628715|NCT01071395|B1|Baseline|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
628716|NCT01071395|P2|Participant Flow|Placebo|Placebo: Sugar pill given 3 times daily
628717|NCT01071395|P1|Participant Flow|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
628718|NCT01071395|O2|Outcome|Placebo|Placebo: Sugar pill given daily in three divided doses
628719|NCT01071395|O1|Outcome|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
628720|NCT01071395|E2|Reported Event|Placebo|Placebo: Sugar pill given 3 times daily
628721|NCT01071395|E1|Reported Event|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
628722|NCT01071538|B1|Baseline|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.
Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
628796|NCT01072032|O1|Outcome|Low-Reward|"Low-Reward Anklebot training Group
Anklebot (Ankle Robot): The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team."
628723|NCT01071538|P1|Participant Flow|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.
Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
628724|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.
Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
628725|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.
Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
628726|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.
Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
628727|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.
Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
628728|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.
Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
628729|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.
Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
628730|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.
Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
628731|NCT01071538|E1|Reported Event|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.
Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
628732|NCT01071798|B1|Baseline|Main Analysis Set|Participants who received at least one cycle of rituximab
628733|NCT01071798|P1|Participant Flow|Main Analysis Set|Participants who received at least one cycle of rituximab
628734|NCT01071798|O3|Outcome|Worse|Clinically relevant worsening of HAQ Score ≥0.3
628735|NCT01071798|O2|Outcome|No Change|Other or no clinical relevant change of HAQ-Score
628736|NCT01071798|O1|Outcome|Improved|Clinically relevant improvement of HAQ-Score ≥0.3
628737|NCT01071798|O3|Outcome|Worse|Clinically relevant worsening of HAQ Score ≥0.3
628738|NCT01071798|O2|Outcome|No Change|Other or no clinical relevant change of HAQ-Score
628739|NCT01071798|O1|Outcome|Improved|Clinically relevant improvement of HAQ-Score ≥0.3
628740|NCT01071798|O3|Outcome|Total|During the Trial - All Participants
628741|NCT01071798|O2|Outcome|Cycle 2|During Cycle 2 - Subpopulation With Two Cycles
628742|NCT01071798|O1|Outcome|Cycle 1|During Cycle 1 - Main Analysis Set
628743|NCT01071798|O3|Outcome|Seropositive Participants|Subgroup of seropositive participants
628744|NCT01071798|O2|Outcome|Seronegative Participants|Subgroup of seronegative participants
628745|NCT01071798|O1|Outcome|Main Analysis Set|Participants who received at least one cycle of rituximab
628746|NCT01071798|O3|Outcome|Seropositive Participants|Subgroup of seropositive participants
628747|NCT01071798|O2|Outcome|Seronegative Participants|Subgroup of seronegative participants
628748|NCT01071798|O1|Outcome|Main Analysis Set|Participants who received at least one cycle of rituximab
628749|NCT01071798|E3|Reported Event|Total|During the entire trial
628750|NCT01071798|E2|Reported Event|Cycle 2|During Cycle 2 - Subpopulation With Two Cycles
628751|NCT01071798|E1|Reported Event|Cycle 1|During Cycle 1 - Main Analysis Set
628752|NCT01071915|B1|Baseline|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
628753|NCT01071915|P1|Participant Flow|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
628754|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
628755|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
628756|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
628757|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
628758|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
628759|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
628760|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
628761|NCT01071915|E1|Reported Event|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
628762|NCT01072006|B5|Baseline|Total|Total of all reporting groups
628763|NCT01072006|B4|Baseline|TBI+PTSD Group|Combined TBI history and PTSD
628764|NCT01072006|B3|Baseline|TBI Group|TBI (no PTSD)
628765|NCT01072006|B2|Baseline|PTSD Group|PTSD (not TBI)
628766|NCT01072006|B1|Baseline|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
628767|NCT01072006|P4|Participant Flow|TBI+PTSD Group|Combined TBI history and PTSD
628768|NCT01072006|P3|Participant Flow|TBI Group|TBI (no PTSD)
628769|NCT01072006|P2|Participant Flow|PTSD Group|PTSD (not TBI)
628770|NCT01072006|P1|Participant Flow|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
628771|NCT01072006|O4|Outcome|TBI+PTSD Group|Combined TBI history and PTSD
628772|NCT01072006|O3|Outcome|TBI Group|TBI (no PTSD)
628773|NCT01072006|O2|Outcome|PTSD Group|PTSD (not TBI)
628774|NCT01072006|O1|Outcome|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
628775|NCT01072006|O4|Outcome|TBI+PTSD Group|Combined TBI history and PTSD
628776|NCT01072006|O3|Outcome|TBI Group|TBI (no PTSD)
628777|NCT01072006|O2|Outcome|PTSD Group|PTSD (not TBI)
628778|NCT01072006|O1|Outcome|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
628779|NCT01072006|O3|Outcome|TBI+PTSD Group|Combined TBI history and PTSD
628780|NCT01072006|O2|Outcome|PTSD Group|PTSD (not TBI)
628781|NCT01072006|O1|Outcome|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
628782|NCT01072006|E4|Reported Event|TBI+PTSD Group|Combined TBI history and PTSD
628785|NCT01072006|E1|Reported Event|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
628786|NCT01072032|B3|Baseline|Total|Total of all reporting groups
628787|NCT01072032|B2|Baseline|High-Reward|"High-Reward Anklebot training Group
Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
628788|NCT01072032|B1|Baseline|Low-Reward|"Low-Reward Anklebot training Group
Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
628789|NCT01072032|P2|Participant Flow|High-Reward|"High-Reward Anklebot training Group
Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
628790|NCT01072032|P1|Participant Flow|Low-Reward|"Low-Reward Anklebot training Group
Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
628791|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
628792|NCT01072032|O1|Outcome|Low-Reward|Low-Reward Anklebot training Group: The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.
628793|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
628794|NCT01072032|O1|Outcome|Low-Reward|Low-Reward Anklebot training Group: The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.
628795|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
628797|NCT01072032|E2|Reported Event|High-Reward|"High-Reward Anklebot training Group
Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
628798|NCT01072032|E1|Reported Event|Low-Reward|"Low-Reward Anklebot training Group
Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
628799|NCT01072136|B3|Baseline|Total|Total of all reporting groups
628800|NCT01072136|B2|Baseline|Placebo|Placebo
628801|NCT01072136|B1|Baseline|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
628802|NCT01072136|P2|Participant Flow|Placebo|Placebo
628803|NCT01072136|P1|Participant Flow|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
628804|NCT01072136|O2|Outcome|Placebo|Placebo
628805|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
628806|NCT01072136|O2|Outcome|Placebo|Placebo
628807|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
628808|NCT01072136|O2|Outcome|Placebo|Placebo
628809|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
628810|NCT01072136|O3|Outcome|Clinical Cure|Clinical Cure for mucopurulent cervicitis
628811|NCT01072136|O2|Outcome|Partial Response|Partial response for mucopurulent cervicitis
628812|NCT01072136|O1|Outcome|Clinical Failure|Clinical failure for mucopurulent cervicitis
628813|NCT01072136|O3|Outcome|Clinical Cure|Clinical Cure for mucopurulent cervicitis
628814|NCT01072136|O2|Outcome|Partial Response|Partial response for mucopurulent cervicitis
628815|NCT01072136|O1|Outcome|Clinical Failure|Clinical failure for mucopurulent cervicitis
628816|NCT01072136|O2|Outcome|Placebo|Placebo
628817|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
628818|NCT01072136|O2|Outcome|Placebo|Placebo
628819|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
628820|NCT01072136|O2|Outcome|Placebo|Placebo
628821|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
628822|NCT01072136|E2|Reported Event|Placebo|Placebo
628823|NCT01072136|E1|Reported Event|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
628824|NCT01072149|B1|Baseline|Entire Study Population|All participants who self-administered placebo, FF/VI 50/25 µg, FF/VI 100/25 µg, or FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI in any of the three 28-day treatment periods.
628825|NCT01072149|P18|Participant Flow|Sequence 18: FF/VI 100/25 µg, Placebo, FF/VI 200/25 µg|Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628846|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
629585|NCT01063153|O2|Outcome|Controls|Controls without ADHD were assessed with a one-time EEG, only.
628826|NCT01072149|P17|Participant Flow|Sequence 17: FF/VI 50/25 µg, Placebo, FF/VI 200/25 µg|Participants self-administered FF/VI 50/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628827|NCT01072149|P16|Participant Flow|Sequence 16: Placebo, FF/VI 50/25 µg, FF/VI 200/25 µg|Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628828|NCT01072149|P15|Participant Flow|Sequence 15: FF/VI 100/25 µg, FF/VI 200/25 µg, Placebo|Participants self-administered FF/VI 100/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628829|NCT01072149|P14|Participant Flow|Sequence 14: FF/VI 200/25 µg, FF/VI 100/25 µg, Placebo|Participants self-administered FF/VI 200/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628830|NCT01072149|P13|Participant Flow|Sequence 13: Placebo, FF/VI 100/25 µg, FF/VI 200/25 µg|Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628831|NCT01072149|P12|Participant Flow|Sequence 12: Placebo, FF/VI 200/25 µg, FF/VI 50/25 µg|Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628832|NCT01072149|P11|Participant Flow|Sequence 11: Placebo, FF/VI 200/25 µg, FF/VI 100/25 µg|Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628833|NCT01072149|P10|Participant Flow|Sequence 10: FF/VI 100/25 µg, Placebo, FF/VI 50/25 µg|Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628859|NCT01072175|B13|Baseline|Total|Total of all reporting groups
629071|NCT01072188|O2|Outcome|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
628834|NCT01072149|P9|Participant Flow|Sequence 9: FF/VI 100/25 µg, FF/VI 50/25 µg, Placebo|Participants self-administered FF/VI 100/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628835|NCT01072149|P8|Participant Flow|Sequence 8: Placebo, FF/VI 50/25 µg, FF/VI 100/25 µg|Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628836|NCT01072149|P7|Participant Flow|Sequence 7: FF/VI 200/25 µg, Placebo, FF/VI 50/25 µg|Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628837|NCT01072149|P6|Participant Flow|Sequence 6: FF/VI 50/25 µg, FF/VI 200/25 µg, Placebo|Participants self-administered FF/VI 50/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628838|NCT01072149|P5|Participant Flow|Sequence 5: FF/VI 50/25 µg, FF/VI 100/25 µg, Placebo|Participants self-administered FF/VI 50/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628839|NCT01072149|P4|Participant Flow|Sequence 4: FF/VI 200/25 µg, Placebo, and FF/VI 100/25 µg|Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628840|NCT01072149|P3|Participant Flow|Sequence 3: FF/VI 200/25 µg, FF/VI 50/25 µg, Placebo|Participants self-administered FF/VI 200/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628841|NCT01072149|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg, FF/VI 50/25 µg|Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628842|NCT01072149|P1|Participant Flow|Sequence 1: FF/VI 50/25 µg, Placebo, FF/VI 100/25 µg|Participants self-administered fluticasone furoate/vilanterol (FF/VI) 50/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
628843|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628844|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628845|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628898|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628847|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628848|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628849|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628850|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
628851|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628852|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628853|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628854|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
628855|NCT01072149|E4|Reported Event|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628856|NCT01072149|E3|Reported Event|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628857|NCT01072149|E2|Reported Event|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
628858|NCT01072149|E1|Reported Event|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
628860|NCT01072175|B12|Baseline|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628861|NCT01072175|B11|Baseline|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628862|NCT01072175|B10|Baseline|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628863|NCT01072175|B9|Baseline|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628864|NCT01072175|B8|Baseline|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
628865|NCT01072175|B7|Baseline|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
628866|NCT01072175|B6|Baseline|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
628867|NCT01072175|B5|Baseline|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628868|NCT01072175|B4|Baseline|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628869|NCT01072175|B3|Baseline|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628870|NCT01072175|B2|Baseline|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628871|NCT01072175|B1|Baseline|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
628872|NCT01072175|P13|Participant Flow|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628873|NCT01072175|P12|Participant Flow|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628929|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
628874|NCT01072175|P11|Participant Flow|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628875|NCT01072175|P10|Participant Flow|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628876|NCT01072175|P9|Participant Flow|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
628877|NCT01072175|P8|Participant Flow|Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
628878|NCT01072175|P7|Participant Flow|Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
628879|NCT01072175|P6|Participant Flow|Part C (Randomized): Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
628880|NCT01072175|P5|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628881|NCT01072175|P4|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628882|NCT01072175|P3|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
629072|NCT01072188|O1|Outcome|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
628883|NCT01072175|P2|Participant Flow|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628884|NCT01072175|P1|Participant Flow|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
628885|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628886|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628887|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628888|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628889|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628890|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628891|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628892|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628893|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628894|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628895|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628896|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628897|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628899|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628900|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628901|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628902|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628903|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628904|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628905|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628906|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628907|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628908|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628909|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628910|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628911|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628912|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628913|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628914|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628915|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628916|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628917|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628918|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628919|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628920|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628921|NCT01072175|O2|Outcome|Part C: Trametinib|Participants received Trametinib 1 mg or 2 mg tablets QD.
628922|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
628923|NCT01072175|O2|Outcome|Part C: Trametinib|Participants received Trametinib 1 mg or 2 mg tablets QD.
628924|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
628925|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
628926|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
628927|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
628928|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
629586|NCT01063153|O1|Outcome|ADHD|Subjects with ADHD were assessed before and after treatment.
628930|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
628931|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
628932|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
628933|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
628934|NCT01072175|O1|Outcome|Part B: Dabrafenib + Trametinib|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib (75 mg or 150 mg) gelatin capsules BID and trametinib (1 mg, 1.5 mg, or 2 mg) tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628935|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628936|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628937|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628990|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628938|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628939|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628940|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628941|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628942|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628943|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628944|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628945|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628977|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
629006|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
629007|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
628946|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628947|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628948|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628949|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628950|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628951|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628952|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628953|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628954|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628955|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628956|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628957|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628958|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628959|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628960|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628961|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628962|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628963|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628964|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628965|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628966|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628967|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628968|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628969|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628970|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628971|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
628972|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628973|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
628974|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
628975|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
628976|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628978|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628979|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628980|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628981|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628982|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628983|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628984|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628985|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628986|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628987|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628988|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628989|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
629073|NCT01072188|O2|Outcome|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
628991|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628992|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628993|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628994|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628995|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628996|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628997|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
628998|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
628999|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
629000|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
629001|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
629002|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
629003|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
629004|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
629005|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
630327|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
629008|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
629009|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
629010|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
629011|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
629012|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
629013|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
629014|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
629015|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
629016|NCT01072175|O1|Outcome|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
629017|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
629018|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
629019|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
629020|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
629021|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
629022|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
629023|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
629024|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
629025|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
629026|NCT01072175|O1|Outcome|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
629027|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
629028|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
629029|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
629030|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
629031|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
629032|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
629033|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
629034|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
629035|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
629036|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
629037|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
629038|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
629039|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
629040|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
629041|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
629042|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
629043|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
629044|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
629070|NCT01072188|P1|Participant Flow|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
629045|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
629046|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
629047|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
629048|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
629049|NCT01072175|O2|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
629050|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
629051|NCT01072175|O2|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
629052|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
629053|NCT01072175|E13|Reported Event|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
629054|NCT01072175|E12|Reported Event|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
629055|NCT01072175|E11|Reported Event|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
629056|NCT01072175|E10|Reported Event|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
629057|NCT01072175|E9|Reported Event|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
629058|NCT01072175|E8|Reported Event|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
630436|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
629059|NCT01072175|E7|Reported Event|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
629060|NCT01072175|E6|Reported Event|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
629061|NCT01072175|E5|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
629062|NCT01072175|E4|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
629063|NCT01072175|E3|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
629064|NCT01072175|E2|Reported Event|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
629065|NCT01072175|E1|Reported Event|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
629066|NCT01072188|B3|Baseline|Total|Total of all reporting groups
629067|NCT01072188|B2|Baseline|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
629068|NCT01072188|B1|Baseline|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
629069|NCT01072188|P2|Participant Flow|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
639828|NCT01092442|O1|Outcome|Retrospective Ross|
629074|NCT01072188|O1|Outcome|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
629075|NCT01072188|E2|Reported Event|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
629076|NCT01072188|E1|Reported Event|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
629077|NCT01072201|B3|Baseline|Total|Total of all reporting groups
629078|NCT01072201|B2|Baseline|Ultrabrite Toothpaste|sodium fluoride control (placebo)
629079|NCT01072201|B1|Baseline|Total Toothpaste|Triclosan/copolymer/Fluoride
629080|NCT01072201|P2|Participant Flow|Ultrabrite Toothpaste|sodium fluoride control(placebo)
629081|NCT01072201|P1|Participant Flow|Total Toothpaste|Triclosan/copolymer/Fluoride
629082|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
629083|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
629084|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
629085|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
629086|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
629087|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
629088|NCT01072201|E2|Reported Event|Ultrabrite Toothpaste|sodium fluoride control (placebo)
629089|NCT01072201|E1|Reported Event|Total Toothpaste|Triclosan/copolymer/Fluoride
629090|NCT01072331|B4|Baseline|Total|Total of all reporting groups
629091|NCT01072331|B3|Baseline|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
629092|NCT01072331|B2|Baseline|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
629093|NCT01072331|B1|Baseline|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
629094|NCT01072331|P3|Participant Flow|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
629095|NCT01072331|P2|Participant Flow|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
629096|NCT01072331|P1|Participant Flow|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
629097|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
629098|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
629099|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
629100|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
629101|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
629102|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
629103|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
629104|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
629105|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
629106|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
629107|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
629108|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
629109|NCT01072331|E3|Reported Event|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
629110|NCT01072331|E2|Reported Event|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
629111|NCT01072331|E1|Reported Event|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
629112|NCT01072344|B3|Baseline|Total|Total of all reporting groups
629113|NCT01072344|B2|Baseline|Placebo|"Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629114|NCT01072344|B1|Baseline|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629115|NCT01072344|P2|Participant Flow|Placebo|"Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629116|NCT01072344|P1|Participant Flow|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629117|NCT01072344|O2|Outcome|Placebo|"Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629118|NCT01072344|O1|Outcome|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629119|NCT01072344|O2|Outcome|Placebo|"Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629120|NCT01072344|O1|Outcome|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629121|NCT01072344|O2|Outcome|Placebo|"Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629122|NCT01072344|O1|Outcome|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629123|NCT01072344|O2|Outcome|Placebo|"Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629124|NCT01072344|O1|Outcome|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629125|NCT01072344|O2|Outcome|Placebo|"Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629126|NCT01072344|O1|Outcome|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629127|NCT01072344|E2|Reported Event|Placebo|"Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629128|NCT01072344|E1|Reported Event|Chamomile Extract|"Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily"
629129|NCT01072357|B3|Baseline|Total|Total of all reporting groups
629130|NCT01072357|B2|Baseline|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
644814|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
629131|NCT01072357|B1|Baseline|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
629132|NCT01072357|P2|Participant Flow|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
629133|NCT01072357|P1|Participant Flow|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
629134|NCT01072357|O2|Outcome|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
629135|NCT01072357|O1|Outcome|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
629163|NCT01072448|O1|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
629341|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
629136|NCT01072357|O2|Outcome|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
629137|NCT01072357|O1|Outcome|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
629138|NCT01072357|E2|Reported Event|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
629139|NCT01072357|E1|Reported Event|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
629140|NCT01072396|B3|Baseline|Total|Total of all reporting groups
629141|NCT01072396|B2|Baseline|Tiotropium/Placebo|Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
629142|NCT01072396|B1|Baseline|Placebo/Tiotropium|Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks
629143|NCT01072396|P2|Participant Flow|Tiotropium/Placebo|Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
629144|NCT01072396|P1|Participant Flow|Placebo/Tiotropium|Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks
629145|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
629146|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
629147|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
629148|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
629149|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
629150|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
629151|NCT01072396|E2|Reported Event|Tiotropium|Patients who received tiotropium in period one or period two
629152|NCT01072396|E1|Reported Event|Placebo|Patients who received placebo in period one or period two
629153|NCT01072409|B1|Baseline|Implanted|Subjects who met study inclusion and completed the primary endpoint.
629154|NCT01072409|P1|Participant Flow|Implanted|Subjects who met study inclusion and completed the primary endpoint.
629155|NCT01072409|O1|Outcome|Implanted|Subjects who met study inclusion and completed the primary endpoint.
629156|NCT01072409|E1|Reported Event|Implanted|Subjects who met study inclusion and completed the primary endpoint.
629157|NCT01072448|B3|Baseline|Total|Total of all reporting groups
629158|NCT01072448|B2|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
629159|NCT01072448|B1|Baseline|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
629160|NCT01072448|P2|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
629161|NCT01072448|P1|Participant Flow|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
629162|NCT01072448|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
636714|NCT01077817|P1|Participant Flow|Overall Study Population|
629164|NCT01072448|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
629165|NCT01072448|O1|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
629166|NCT01072448|E2|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
629167|NCT01072448|E1|Reported Event|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
629168|NCT01072500|B3|Baseline|Total|Total of all reporting groups
629169|NCT01072500|B2|Baseline|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
629170|NCT01072500|B1|Baseline|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
629171|NCT01072500|P2|Participant Flow|Successful Aging (Health Education)|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
629172|NCT01072500|P1|Participant Flow|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
629173|NCT01072500|O2|Outcome|Successful Aging|"The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
Successful Aging: The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises."
629174|NCT01072500|O1|Outcome|Physical Activity|"The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
Physical Activity: The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling."
630303|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
629175|NCT01072500|O2|Outcome|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
629176|NCT01072500|O1|Outcome|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
629177|NCT01072500|E2|Reported Event|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
629178|NCT01072500|E1|Reported Event|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
629179|NCT01072526|B1|Baseline|2 Arm Study - Description Below|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629180|NCT01072526|P2|Participant Flow|Control|Cyclosporin (Restasis)ophthalmic solution; 1 drop both eyes twice daily plus placebo solution. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629181|NCT01072526|P1|Participant Flow|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629182|NCT01072526|O2|Outcome|Control|"Subjects will receive placebo in combination with cyclosporin (Restasis) solution.
Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily"
629183|NCT01072526|O1|Outcome|Intervention|"Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin (Restasis) solution.
Euphrasia-based homeopathic therapy: ophthalmic solution; 1 drop both eyes twice daily
Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily"
629184|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629185|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629186|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629225|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629187|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629188|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629189|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629190|NCT01072526|O2|Outcome|Control|cyclosporin ophthalmic solution plus placebo solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629191|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629192|NCT01072526|E1|Reported Event|2 Arm Study - Description Below|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
629193|NCT01072539|B1|Baseline|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
629194|NCT01072539|P1|Participant Flow|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
629195|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
629196|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
629197|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
632300|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Week 0-24): Sitagliptin 100 mg
629198|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
629199|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
629200|NCT01072539|E1|Reported Event|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
629201|NCT01072617|B1|Baseline|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days
Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.
Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
629202|NCT01072617|P1|Participant Flow|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days
Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.
Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
629203|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.
Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
629226|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629227|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629204|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.
Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
629205|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.
Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
629206|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days
Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.
Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
629207|NCT01072617|E1|Reported Event|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days
Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.
Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
629208|NCT01072630|B4|Baseline|Total|Total of all reporting groups
629209|NCT01072630|B3|Baseline|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629210|NCT01072630|B2|Baseline|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629211|NCT01072630|B1|Baseline|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629212|NCT01072630|P3|Participant Flow|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629213|NCT01072630|P2|Participant Flow|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629214|NCT01072630|P1|Participant Flow|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629215|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629216|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629217|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629218|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629219|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629220|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629221|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629222|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629223|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629224|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629337|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at a 1.0% concentration
629228|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629229|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629230|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629231|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629232|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629233|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629234|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629235|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629236|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629237|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629238|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629239|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629240|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629241|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
632301|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
629242|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629243|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629244|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629245|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629246|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629247|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629248|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629249|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629250|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629251|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629252|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629253|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629254|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629255|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629256|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629257|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629258|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629259|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629260|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629261|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629262|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629263|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629264|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629265|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629266|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629267|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629268|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629269|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629314|NCT01072669|E2|Reported Event|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
629270|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629271|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629272|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629273|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629274|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629275|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629276|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629277|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629278|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629279|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629280|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629281|NCT01072630|O3|Outcome|All Armodafinil|This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks.
629282|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629283|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629284|NCT01072630|E3|Reported Event|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629285|NCT01072630|E2|Reported Event|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629286|NCT01072630|E1|Reported Event|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629287|NCT01072643|B1|Baseline|Dexmedetomidine|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr
Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
629288|NCT01072643|P1|Participant Flow|Dexmedetomidine 1 mcg/kg Bolus|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr
Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
629289|NCT01072643|O4|Outcome|Subject 4|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
629290|NCT01072643|O3|Outcome|Subject 3|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
629291|NCT01072643|O2|Outcome|Subject 2|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
629292|NCT01072643|O1|Outcome|Subject 1|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
629293|NCT01072643|E1|Reported Event|Dexmedetomidine|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr
Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
629294|NCT01072656|B3|Baseline|Total|Total of all reporting groups
629295|NCT01072656|B2|Baseline|Sham First|sham stimulation - IPG ON, at 0 Volt
629296|NCT01072656|B1|Baseline|Active First|active stimulation programmed to the settings found to be optimal during the titration phase
629297|NCT01072656|P2|Participant Flow|Sham First|sham stimulation - IPG ON, at 0 Volt
629298|NCT01072656|P1|Participant Flow|Active First|active stimulation programmed to the settings found to be optimal during the titration phase
629299|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
629300|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
629301|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
629302|NCT01072656|O2|Outcome|Sham Stimulation|"IPG is set to ON but the voltage is set to 0V.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
629338|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam at a 0.5% concentration
629339|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
629340|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle
Placebo Vehicle: Placebo vehicle"
629303|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
629304|NCT01072656|E3|Reported Event|Phase I-IV|Phase I-IV is time frame of patient consent through surgery just prior to beginning Active v Sham Stimulation Phase.
629305|NCT01072656|E2|Reported Event|Sham Stimulation (Phase V)|"IPG is set to ON but the voltage is set to 0V.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
629306|NCT01072656|E1|Reported Event|Active Stimulation (Phase V)|"Active stimulation and programmed to the settings found to be optimal during the titration process.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
629307|NCT01072669|B3|Baseline|Total|Total of all reporting groups
629308|NCT01072669|B2|Baseline|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
629309|NCT01072669|B1|Baseline|Ambrisentan|"drug arm
use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
629310|NCT01072669|P2|Participant Flow|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
629311|NCT01072669|P1|Participant Flow|Ambrisentan|"drug arm
use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
629312|NCT01072669|O2|Outcome|Sugar Pill|Placebo, same appearing as Ambrisentan
629313|NCT01072669|O1|Outcome|Ambrisentan|Ambrisentan 5 mg daily for 1 month, then 10 mg daily for 2 months
644815|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
629315|NCT01072669|E1|Reported Event|Ambrisentan|"drug arm
use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
629316|NCT01072773|B1|Baseline|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
629317|NCT01072773|P1|Participant Flow|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
629318|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
629319|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
629320|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
629321|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
629322|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
629323|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
629324|NCT01072773|E1|Reported Event|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
629325|NCT01072877|B6|Baseline|Total|Total of all reporting groups
629326|NCT01072877|B5|Baseline|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam2.0%
629327|NCT01072877|B4|Baseline|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam 1.0%
629328|NCT01072877|B3|Baseline|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam 0.5%
629329|NCT01072877|B2|Baseline|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam 0.125%
629330|NCT01072877|B1|Baseline|Vehicle|"Injection of vehicle comparator
Placebo Vehicle: Placebo vehicle"
629331|NCT01072877|P5|Participant Flow|Polidocanol Endovenous Microfoam 2.0%|"Polidocanol endovenous microfoam 2.0%
Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
629332|NCT01072877|P4|Participant Flow|Polidocanol Endovenous Microfoam 1.0%|"Polidocanol endovenous microfoam 1.0%
Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
629333|NCT01072877|P3|Participant Flow|Polidocanol Endovenous Microfoam 0.5%|"Polidocanol endovenous microfoam 0.5%
Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
629334|NCT01072877|P2|Participant Flow|Polidocanol Endovenous Microfoam 0.125%|"Polidocanol endovenous microfoam 0.125%
Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
629335|NCT01072877|P1|Participant Flow|Vehicle|"Injection of vehicle comparator
Placebo Vehicle: Placebo vehicle"
629336|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
629342|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at a 1.0% concentration
629343|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam at a 0.5% concentration
629344|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
629345|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle
Placebo Vehicle: Placebo vehicle"
629346|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
629347|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at 1.0% concentration
629348|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|polidocanol injectable foam at a 0.5% concentration
629349|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
629350|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle
Placebo Vehicle: Placebo vehicle"
629351|NCT01072877|E5|Reported Event|Polidocanol Endovenous Microfoam 2.0%|polidocanol injectable foam at a 2.0% concentration
629352|NCT01072877|E4|Reported Event|Polidocanol Injectable Foam 1.0%|polidocanol injectable foam at a 1.0% concentration
629353|NCT01072877|E3|Reported Event|Polidcanol Injectable Foam 0.5%|polidocanol injectable foam at a 0.5% concentration
629354|NCT01072877|E2|Reported Event|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam at a 0.125% concentration
629355|NCT01072877|E1|Reported Event|Vehicle|"Injection of vehicle
Placebo Vehicle: Placebo vehicle"
629356|NCT01072929|B4|Baseline|Total|Total of all reporting groups
629357|NCT01072929|B3|Baseline|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629358|NCT01072929|B2|Baseline|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629359|NCT01072929|B1|Baseline|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629360|NCT01072929|P3|Participant Flow|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629361|NCT01072929|P2|Participant Flow|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629362|NCT01072929|P1|Participant Flow|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629363|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629364|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629365|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629366|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629367|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629368|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629369|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629370|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629371|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629372|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629373|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629374|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629375|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629376|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629377|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629587|NCT01063153|E2|Reported Event|ADHD|Subjects with ADHD were assessed with EEG before and after open-label treatment with Concerta.
629378|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629379|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629380|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629381|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629382|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629383|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629384|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629385|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629386|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629387|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629388|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629389|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629390|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629391|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629392|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629393|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629394|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629395|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629396|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629397|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629398|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629399|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629400|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629401|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629402|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629403|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629404|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629405|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629472|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629406|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629407|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629408|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629409|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629410|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629411|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629412|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629413|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629414|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629415|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629416|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629417|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629418|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629419|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629651|NCT01063595|E1|Reported Event|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
629420|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629421|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629422|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629423|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629424|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629425|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629426|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629427|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629428|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629429|NCT01072929|O3|Outcome|All Armodafinil|This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks.
629430|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629431|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629432|NCT01072929|E3|Reported Event|PLACEBO|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
629433|NCT01072929|E2|Reported Event|ARMODAFINIL 200 MG|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
629434|NCT01072929|E1|Reported Event|ARMODAFINIL 150 MG|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
629588|NCT01063153|E1|Reported Event|Control|Subjects without ADHD were assessed using EEG.
629435|NCT01073163|B1|Baseline|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629436|NCT01073163|P1|Participant Flow|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629437|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629438|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629439|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629440|NCT01073163|O3|Outcome|Total|All participants administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629441|NCT01073163|O2|Outcome|Mantle Cell Lymphoma|Participants with mantle cell lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629442|NCT01073163|O1|Outcome|Non-Hodgkin Lymphoma|Participants with non-Hodgkin Lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629443|NCT01073163|O3|Outcome|Total|All participants administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629444|NCT01073163|O2|Outcome|Mantle Cell Lymphoma|Participants with mantle cell lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629445|NCT01073163|O1|Outcome|Non-Hodgkin Lymphoma|Participants with non-Hodgkin Lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629446|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629447|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on day 1 of each 28-day cycle.
629448|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on day 1 of each 28-day cycle.
644816|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
629449|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629450|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629451|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629452|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629453|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629454|NCT01073163|E1|Reported Event|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
629455|NCT01062841|B3|Baseline|Total|Total of all reporting groups
629456|NCT01062841|B2|Baseline|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629457|NCT01062841|B1|Baseline|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629458|NCT01062841|P2|Participant Flow|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. Surveillance cultures and data was collected for outcome comparison only.
629487|NCT01063036|P1|Participant Flow|Entecavir + Tenofovir|"Entecavir (ETV) : Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629488|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629489|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629589|NCT01063348|B3|Baseline|Total|Total of all reporting groups
629459|NCT01062841|P1|Participant Flow|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) monthly using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629460|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629461|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629462|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629463|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629464|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629465|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629466|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629506|NCT01063049|P1|Participant Flow|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
632302|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg
629467|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629468|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629469|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629470|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629471|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
632331|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
629473|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629474|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629475|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629476|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629477|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629478|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629479|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629480|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629536|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629481|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629482|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629483|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629484|NCT01062841|E2|Reported Event|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
629485|NCT01062841|E1|Reported Event|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
629486|NCT01063036|B1|Baseline|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629490|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629491|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629492|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629493|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629494|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629495|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629496|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629497|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629498|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
629499|NCT01063036|E1|Reported Event|Entecavir + Tenofovir|Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks
629500|NCT01063049|B4|Baseline|Total|Total of all reporting groups
629501|NCT01063049|B3|Baseline|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
629502|NCT01063049|B2|Baseline|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
629503|NCT01063049|B1|Baseline|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
629504|NCT01063049|P3|Participant Flow|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
629505|NCT01063049|P2|Participant Flow|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
632549|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
629507|NCT01063049|O3|Outcome|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
629508|NCT01063049|O2|Outcome|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
629509|NCT01063049|O1|Outcome|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
629510|NCT01063049|O3|Outcome|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
629511|NCT01063049|O2|Outcome|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
629512|NCT01063049|O1|Outcome|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
629513|NCT01063049|E3|Reported Event|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
629514|NCT01063049|E2|Reported Event|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
629515|NCT01063049|E1|Reported Event|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
629516|NCT01063062|B3|Baseline|Total|Total of all reporting groups
629517|NCT01063062|B2|Baseline|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629518|NCT01063062|B1|Baseline|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629519|NCT01063062|P2|Participant Flow|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629520|NCT01063062|P1|Participant Flow|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629583|NCT01063153|O2|Outcome|Control Group and Visual NoGo Task|Participants without a DSM-IV diagnosis of ADHD completed the NoGo Visual Task, in which they had to refrain from responding.
637751|NCT01091116|O1|Outcome|Low Dose|two doses
629521|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629522|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629523|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629524|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629525|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629526|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629527|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629528|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629529|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629530|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629531|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629532|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629533|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629534|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629535|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
632550|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
629537|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629538|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629539|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629540|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629541|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629542|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629543|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629544|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629545|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629546|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629547|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629548|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629549|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629550|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629551|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629552|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629553|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629554|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629555|NCT01063062|E2|Reported Event|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
629556|NCT01063062|E1|Reported Event|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
629557|NCT01063075|B1|Baseline|All Participants (Group A, B, C and D)|"Group D:
Cycle 1:400 mg/m² cetuximab week (w) 1,day(d) 1.Carboplatin(AUC=5) on w 1, d 1.Optional 1000 mg/m²/d 5-FU given as a 96-hour C.I. starting(strt) on w 1, d 1.
Group C:
Cycle 1:Carboplatin(AUC=5) on w 1,d 1. 400 mg/m² cetuximab on w 2, d 1.Cetuximab 250 mg/m ² on w 3 and 4, d 1.
Cycle 2-6:Carboplatin(AUC=5) and 250 mg/m² cetuximab on w 1, d 1.1000 mg/m²/d 5-FU given as a 96-hour C.I. strt on w 1, d 1.250 mg/m² cetuximab on w 2 and 3, d 1.
Group B:
Cycle 1:400 mg/m² cetuximab on w 1, d 1. 250 mg/m ² cetuximab on w 2 and 3, d 1.
Cycle 2:Carboplatin(AUC=5) w 1, d 1.1000 mg/m ²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m ² cetuximab w 1- 3, d 1.
Group A:
Cycle 1:Carboplatin(AUC=5) on w 1, d 1. 1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1.
400 mg/m² cetuximab on w 2, d 1 and 250 mg/m² cetuximab on w 3, d 1. Cycle 2:Carboplatin(AUC=5) given I.V on w 1, d 1.1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m² cetuximab on w 1-3, d 1."
629558|NCT01063075|P4|Participant Flow|Cetuximab and Carboplatin (D)|"Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
629559|NCT01063075|P3|Participant Flow|Cetuximab and Carboplatin (C)|"Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
629560|NCT01063075|P2|Participant Flow|Cetuximab and Carboplatin (B)|"Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1."
629561|NCT01063075|P1|Participant Flow|Carboplatin and Cetuximab (A)|"Group A:
Cycle 1 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 milligrams per square meter (mg/m ²) cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1."
629562|NCT01063075|O1|Outcome|Cetuximab (D)|"Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
629563|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
629564|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
629565|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
629584|NCT01063153|O1|Outcome|ADHD and Visual NoGo Task|Participants with a DSM-IV diagnosis of ADHD completed the NoGo Visual Task, in which they had to refrain from responding.
629566|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
629567|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
629568|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
629569|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
629570|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
629571|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
629572|NCT01063075|E4|Reported Event|Carboplatin and Cetuximab (D)|"Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on day 1. Carboplatin area under the curve (AUC=5) administered I.V on day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on day 1."
629573|NCT01063075|E3|Reported Event|Carboplatin and Cetuximab (C)|"Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
629574|NCT01063075|E2|Reported Event|Carboplatin and Cetuximab (B)|"Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1."
629575|NCT01063075|E1|Reported Event|Carboplatin and Cetuximab (A)|"Group A:
Cycle 1 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m ² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1."
629576|NCT01063153|B3|Baseline|Total|Total of all reporting groups
629577|NCT01063153|B2|Baseline|ADHD|Subjects with ADHD
629578|NCT01063153|B1|Baseline|Control|Subjects without ADHD
629579|NCT01063153|P2|Participant Flow|ADHD|Subjects with ADHD were assessed with EEG before and after treatment with Concerta
629580|NCT01063153|P1|Participant Flow|Control|Controls without ADHD were assessed using EEG
629581|NCT01063153|O4|Outcome|Control Group and Visual Go Task|Participants without a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
629582|NCT01063153|O3|Outcome|ADHD and Visual Go Task|Participants with a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
629590|NCT01063348|B2|Baseline|Placebo|"Matching placebo taken daily
Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
629591|NCT01063348|B1|Baseline|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)
N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
629592|NCT01063348|P2|Participant Flow|Placebo|"Matching placebo taken daily
Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
629593|NCT01063348|P1|Participant Flow|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)
N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
629594|NCT01063348|O2|Outcome|Placebo|"Matching placebo taken daily
Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
629595|NCT01063348|O1|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)
N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
629596|NCT01063348|O2|Outcome|Placebo|"Matching placebo taken daily
Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
629597|NCT01063348|O1|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)
N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
629598|NCT01063348|E2|Reported Event|Placebo|"Matching placebo taken daily
Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
629599|NCT01063348|E1|Reported Event|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)
N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
629600|NCT01063517|B3|Baseline|Total|Total of all reporting groups
629601|NCT01063517|B2|Baseline|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629602|NCT01063517|B1|Baseline|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629603|NCT01063517|P2|Participant Flow|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629604|NCT01063517|P1|Participant Flow|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629605|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629606|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629607|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629608|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629609|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629610|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629611|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629612|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629613|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
637752|NCT01091116|O5|Outcome|Placebo|two doses
629614|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629615|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629616|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629617|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629618|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629619|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629620|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629621|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629622|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629623|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629624|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629625|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629626|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629627|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629628|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629629|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629630|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629631|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629632|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629633|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629634|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
637753|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
629635|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629636|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629637|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
629638|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
629639|NCT01063517|E2|Reported Event|PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD|
629640|NCT01063517|E1|Reported Event|OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD|
629641|NCT01063595|B1|Baseline|All Participants|Participants received 1200 mL of Octaplas LG intravenously once and 1200 mL of Octaplas SD intravenously once in a crossover design.
629642|NCT01063595|P2|Participant Flow|Octaplas LG First, Then Octaplas SD|Participants received 1200 mL of Octaplas LG intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas SD intravenously once.
629643|NCT01063595|P1|Participant Flow|Octaplas SD First, Then Octaplas LG|Participants received 1200 mL of Octaplas SD intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas LG intravenously once.
629644|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
629645|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
629646|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
629647|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
629648|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
629649|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
629650|NCT01063595|E2|Reported Event|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
632551|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
629652|NCT01063712|B1|Baseline|"Effectiveness of the Device: Nit-Occlud® PDA-R"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.
This group of patients were chosen because they have duct in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
629653|NCT01063712|P1|Participant Flow|"Nit-Occlud® PDA-R Implantations Group"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.
This group of patients were chosen because they have ducts in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
629654|NCT01063712|O1|Outcome|Number of Patients With Complete Regression of Dilation|"Children born with patent arterial duct develop cardiac insufficiency early in life. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the duct on time. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method.
This group of patients had 2-8 mm ductus, haven´t developed pulmonary hypertension and have enough weight to be treated.
Patients with left to right shunt show a dilation of left ventricle and left atrium. The quotient Left atrium/aortic ring is a well known method to estimate the grade of the dilation of the left atrium. The M-Mode method, is useful to assessed the regression of the ventricle after the ducts is closed. These observations were made at the beginning of the study and after six months."
629655|NCT01063712|O1|Outcome|Closure in the Control Period|"The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or color flow) in the control period is given as number and as percentage of the complete group."
629656|NCT01063712|E1|Reported Event|"Effectiveness of the Device: Nit-Occlud® PDA-R"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.
This group of patients were chosen because they have duct in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
629657|NCT01063764|B1|Baseline|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629658|NCT01063764|P1|Participant Flow|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629659|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629660|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629661|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629662|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629663|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629664|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629665|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629757|NCT01063907|E6|Reported Event|Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2|Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 + BTZ at the RP2D (KW-2478 175 mg/m^2/BTZ 1.3 mg/m^2).
629666|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629667|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629668|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629669|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629744|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
632552|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
629670|NCT01063764|E1|Reported Event|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
629671|NCT01063855|B3|Baseline|Total|Total of all reporting groups
629672|NCT01063855|B2|Baseline|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629673|NCT01063855|B1|Baseline|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629674|NCT01063855|P2|Participant Flow|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629675|NCT01063855|P1|Participant Flow|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629676|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629677|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629678|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629679|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629680|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629800|NCT01064284|E2|Reported Event|rFVIII|"Recombinant FVIII
Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629681|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629682|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629683|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629684|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629685|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629686|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629687|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629688|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629689|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629690|NCT01063855|O4|Outcome|PDE5I + Dapoxetine (Week 12)|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
629691|NCT01063855|O3|Outcome|PDE5I + Dapoxetine (Baseline)|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
629827|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
629692|NCT01063855|O2|Outcome|PDE5I + Placebo (Week 12)|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629693|NCT01063855|O1|Outcome|PDE5I + Placebo (Baseline)|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629694|NCT01063855|E2|Reported Event|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629695|NCT01063855|E1|Reported Event|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
629696|NCT01063868|B3|Baseline|Total|Total of all reporting groups
629697|NCT01063868|B2|Baseline|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
629698|NCT01063868|B1|Baseline|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
629699|NCT01063868|P2|Participant Flow|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
629700|NCT01063868|P1|Participant Flow|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
629701|NCT01063868|O2|Outcome|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
629702|NCT01063868|O1|Outcome|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
629703|NCT01063868|E2|Reported Event|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
629704|NCT01063868|E1|Reported Event|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
629705|NCT01063881|B4|Baseline|Total|Total of all reporting groups
629706|NCT01063881|B3|Baseline|Dapoxetine 30 to 60 to 30 mg|13 patients took at least one dose of dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629707|NCT01063881|B2|Baseline|Dapoxetine 30 to 60 mg|124 of 125 patients took at least one dose of dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629708|NCT01063881|B1|Baseline|Dapoxetine 30 mg Only|144 of 147 patients took at least 1 dose of dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629924|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
629709|NCT01063881|P3|Participant Flow|Dapoxetine 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629710|NCT01063881|P2|Participant Flow|Dapoxetine 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629711|NCT01063881|P1|Participant Flow|Dapoxetine 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629712|NCT01063881|O2|Outcome|Dapoxetine (Patients With IELT >1 Minute, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
629713|NCT01063881|O1|Outcome|Dapoxetine (Patients With IELT <1 Minute, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
629714|NCT01063881|O2|Outcome|Dapoxetine (Patients With Acquired PE, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
629715|NCT01063881|O1|Outcome|Dapoxetine (Patients With Life-long PE, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
629716|NCT01063881|O3|Outcome|Dapoxetine 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629717|NCT01063881|O2|Outcome|Dapoxetine 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629718|NCT01063881|O1|Outcome|Dapoxetine 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629719|NCT01063881|O1|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
629828|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
629720|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
629721|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
629722|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
629723|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
629724|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
629725|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
629726|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
629727|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
629728|NCT01063881|O1|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
629729|NCT01063881|E3|Reported Event|Depoxetine (DPX) 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629730|NCT01063881|E2|Reported Event|Depoxetine (DPX) 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629731|NCT01063881|E1|Reported Event|Depoxetine (DPX) 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
629758|NCT01063907|E5|Reported Event|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
632332|NCT01076088|O4|Outcome|Metformin 850 mg|Metformin 850 mg twice daily
629732|NCT01063907|B1|Baseline|KW-2478 and Bortezomib|"The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and Bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts (overall N=15). The Phase 2 portion of the study enrolled 80 subjects to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2 / Bortezomib 1.3 mg/m^2)."
629733|NCT01063907|P2|Participant Flow|Phase II: KW-2478 130mg/m^2 and Bortezomib 1.3mg/m^2|"The target population in Phase 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
For the Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and bortezomib at the RP2D (KW-2478 175 mg/m^2/bortezomib1.3 mg/m^2)."
629734|NCT01063907|P1|Participant Flow|Phase 1: KW-2478 and Bortezomib|"The target population in Phase 1 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts."
629735|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
629736|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
629737|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
629738|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
629739|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629740|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629741|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629742|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629743|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629829|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
629745|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629746|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629747|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
629748|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
629749|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
629750|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
629751|NCT01063907|O6|Outcome|Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2).
629752|NCT01063907|O5|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629753|NCT01063907|O4|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629754|NCT01063907|O3|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629755|NCT01063907|O2|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629756|NCT01063907|O1|Outcome|Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|"The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m^2) and Bortezomib (1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.
The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2)."
629925|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
629759|NCT01063907|E4|Reported Event|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0 mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629760|NCT01063907|E3|Reported Event|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3 mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629761|NCT01063907|E2|Reported Event|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0 mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
629762|NCT01063907|E1|Reported Event|Phase 1 and 2: KW-2478 and Bortezomib|KW-2478 and bortezomib: KW 2478 and bortezomib given on Days 1, 4, 8 and 11 of a 21 day cycle
629763|NCT01064076|B1|Baseline|S-ICD System|This is a single arm study
629764|NCT01064076|P1|Participant Flow|S-ICD System|This is a single arm study
629765|NCT01064076|O1|Outcome|S-ICD System|This is a single arm study
629766|NCT01064076|O1|Outcome|Single Arm|Cohort includes all subjects undergoing an implant attempt
629767|NCT01064076|E1|Reported Event|S-ICD System|This is a single arm study
629768|NCT01064167|B3|Baseline|Total|Total of all reporting groups
629769|NCT01064167|B2|Baseline|Control Group|The placebo consisted of an equivalent volume of saline solution.
629770|NCT01064167|B1|Baseline|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
629771|NCT01064167|P2|Participant Flow|Control Group|The placebo consisted of an equivalent volume of saline solution.
629772|NCT01064167|P1|Participant Flow|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
629773|NCT01064167|O2|Outcome|Control Group|The placebo consisted of an equivalent volume of saline solution.
629774|NCT01064167|O1|Outcome|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
629775|NCT01064167|O2|Outcome|Control Group|The placebo consisted of an equivalent volume of saline solution.
629776|NCT01064167|O1|Outcome|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
629777|NCT01064167|E2|Reported Event|Control Group|The placebo consisted of an equivalent volume of saline solution.
629778|NCT01064167|E1|Reported Event|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
629779|NCT01064284|B3|Baseline|Total|Total of all reporting groups
629780|NCT01064284|B2|Baseline|rFVIII|"Recombinant FVIII
Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629781|NCT01064284|B1|Baseline|pd vWF/FVIII|"Plasma-derived vWF/FVIII
PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
632553|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
629782|NCT01064284|P2|Participant Flow|rFVIII|"Recombinant FVIII
Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629783|NCT01064284|P1|Participant Flow|pd vWF/FVIII|"Plasma-derived vWF/FVIII
PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629784|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII
Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629785|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII
PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629786|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII
Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629787|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII
PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629788|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII
Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629789|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII
PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629790|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII
Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629791|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII
PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629792|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII
Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629793|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII
PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629794|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII
Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629795|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII
PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629796|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII
Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629797|NCT01064284|O1|Outcome|PLASMA DERIVED Factor VIII|"Plasma-derived vWF/FVIII
PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629798|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII
Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629799|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII
PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629801|NCT01064284|E1|Reported Event|pd vWF/FVIII|"Plasma-derived vWF/FVIII
PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
629802|NCT01064297|B4|Baseline|Total|Total of all reporting groups
629803|NCT01064297|B3|Baseline|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges
629804|NCT01064297|B2|Baseline|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges
629805|NCT01064297|B1|Baseline|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day
629806|NCT01064297|P3|Participant Flow|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges
629807|NCT01064297|P2|Participant Flow|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges
629808|NCT01064297|P1|Participant Flow|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day
629809|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
629810|NCT01064297|O3|Outcome|Doses Higher Than Prescribed|>400 mg/day maximal dose in first trimester
629811|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
629812|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
629813|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
629814|NCT01064297|O3|Outcome|Doses Higher Than Prescribed|>400 mg/day maximal dose in first trimester
629815|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
629816|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
629817|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
629818|NCT01064297|O3|Outcome|Dose Higher Than Prescribed|>400 mg/day maximal dose in first trimester
629819|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
629820|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
629821|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
629822|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
629823|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
629824|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
629825|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
629826|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
632554|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
629830|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
629831|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
629832|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
629833|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
629834|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
629835|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
629836|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
629837|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
629838|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
629839|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
629840|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
629841|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
629842|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
629843|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
629844|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
629845|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
629846|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
629847|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
629848|NCT01064297|E3|Reported Event|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
629849|NCT01064297|E2|Reported Event|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
629850|NCT01064297|E1|Reported Event|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
629851|NCT01064310|B3|Baseline|Total|Total of all reporting groups
629926|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
629927|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
629852|NCT01064310|B2|Baseline|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
629853|NCT01064310|B1|Baseline|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
629854|NCT01064310|P3|Participant Flow|Open Label Pazopinib|To provide continued access to treatment
629855|NCT01064310|P2|Participant Flow|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
629856|NCT01064310|P1|Participant Flow|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
629857|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629901|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629902|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629903|NCT01064323|E1|Reported Event|Intermittent Leg Compression|Intermittent leg compression for one hour.
629904|NCT01064362|B3|Baseline|Total|Total of all reporting groups
629858|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629859|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629860|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629861|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629862|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629863|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629928|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
629929|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
632333|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
629864|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629865|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629866|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629867|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629868|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629869|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629870|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629871|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
629905|NCT01064362|B2|Baseline|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
629906|NCT01064362|B1|Baseline|Fondaparinux|All dosages of fondaparinux
632555|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
629872|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
629873|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
629874|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
629875|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629930|NCT01064401|E2|Reported Event|DAC HYP 150 mg|DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
629876|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
629877|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
629878|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
629879|NCT01064310|E3|Reported Event|Open Label Pazopanib|Open Label Pazopanib
629880|NCT01064310|E2|Reported Event|Pazopanib|Pazopanib
629881|NCT01064310|E1|Reported Event|Sunitinib|Sunitinib
629882|NCT01064323|B1|Baseline|Intermittent Leg Compression|"Intermittent leg compression daily for 3 hrs a day for 4 weeks
Intermittent pneumatic compression of the lower extremities: IPC will be done for 3 divided hours daily for 4 weeks"
629883|NCT01064323|P1|Participant Flow|Intermittent Leg Compression|Intermittent leg compression for one hour.
629884|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629885|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629886|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629887|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629888|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629889|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629890|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629891|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629892|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629893|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629894|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629895|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629896|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629897|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629898|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629899|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629900|NCT01064323|O1|Outcome|Intermittent Leg Compression|Intermittent leg compression for one hour.
629907|NCT01064362|P2|Participant Flow|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
629908|NCT01064362|P1|Participant Flow|Fondaparinux|All dosages of fondaparinux
629909|NCT01064362|O2|Outcome|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
629910|NCT01064362|O1|Outcome|Fondaparinux|All dosages of fondaparinux
629911|NCT01064362|O2|Outcome|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
629912|NCT01064362|O1|Outcome|Fondaparinux|All dosages of fondaparinux
629913|NCT01064362|E2|Reported Event|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
629914|NCT01064362|E1|Reported Event|Fondaparinux|All dosages of fondaparinux
629915|NCT01064401|B3|Baseline|Total|Total of all reporting groups
629916|NCT01064401|B2|Baseline|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
629917|NCT01064401|B1|Baseline|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
629918|NCT01064401|P2|Participant Flow|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a intramuscular IM injection once weekly for 96 to 144 weeks
629919|NCT01064401|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly plus placebo to daclizumab high yield process (DAC HYP) subcutaneous (SC) once every 4 weeks for 96 to 144 weeks
629920|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
629921|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
629922|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
629923|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
629931|NCT01064401|E1|Reported Event|IFN Beta-1a 30 mcg|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
629932|NCT01064414|B4|Baseline|Total|Total of all reporting groups
629933|NCT01064414|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks.
629934|NCT01064414|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks.
629935|NCT01064414|B1|Baseline|Placebo|Each patient received matching placebo once daily for 52 weeks.
629936|NCT01064414|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks.Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
629937|NCT01064414|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
629938|NCT01064414|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
629939|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
629940|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
629941|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
629942|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
629943|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
629944|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
629945|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
629946|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
629947|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
629948|NCT01064414|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
629949|NCT01064414|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
629950|NCT01064414|E4|Reported Event|Placebo: Baseline to Week 52|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 52.
629951|NCT01064414|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
632556|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
629952|NCT01064414|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
629953|NCT01064414|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26.
629954|NCT01064622|B4|Baseline|Total|Total of all reporting groups
629955|NCT01064622|B3|Baseline|Phase I lead-in Patients|Patients enrolled in the lead-in phase I portion of the trial. Patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and 150 mg vismodegib PO QD on days 1-28.
629956|NCT01064622|B2|Baseline|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV"
629957|NCT01064622|B1|Baseline|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO"
629958|NCT01064622|P2|Participant Flow|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV"
629959|NCT01064622|P1|Participant Flow|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO"
629960|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
629961|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV"
629962|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO"
629963|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
629964|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV"
630224|NCT01064817|O2|Outcome|Placebo|"Placebo
Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
629965|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO"
629966|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
629967|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV"
629968|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO"
629969|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
629970|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV"
629971|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO"
629972|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
629973|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV"
629974|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO"
629975|NCT01064622|E4|Reported Event|Phase II Crossover Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
644897|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
629976|NCT01064622|E3|Reported Event|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
629977|NCT01064622|E2|Reported Event|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV"
629978|NCT01064622|E1|Reported Event|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO"
629979|NCT01064687|B5|Baseline|Total|Total of all reporting groups
629980|NCT01064687|B4|Baseline|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
629981|NCT01064687|B3|Baseline|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629982|NCT01064687|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629983|NCT01064687|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629984|NCT01064687|P4|Participant Flow|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
629985|NCT01064687|P3|Participant Flow|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629986|NCT01064687|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629987|NCT01064687|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629988|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629989|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629990|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
629991|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629992|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629993|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629994|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629995|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629996|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629997|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
629998|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
629999|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630000|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630001|NCT01064687|O5|Outcome|Placebo/0.75 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630002|NCT01064687|O4|Outcome|Placebo/1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630003|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630004|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630005|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630006|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630007|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630008|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630009|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630010|NCT01064687|O3|Outcome|Placebo/0.75 mg LY2189265 or 1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630011|NCT01064687|O2|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630012|NCT01064687|O1|Outcome|0.75 mg LY2189265 or 1.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630013|NCT01064687|O3|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630014|NCT01064687|O2|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630015|NCT01064687|O1|Outcome|0.75 mg LY2189265 or 1.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630324|NCT01065051|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630016|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630017|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630018|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630019|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630020|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630021|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630022|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630023|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630024|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630025|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630026|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630027|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630028|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630136|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630029|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630030|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630031|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630032|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630033|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630034|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630035|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630036|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630037|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630038|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630039|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630040|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630041|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630325|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
630042|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630043|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630044|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630045|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630046|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630047|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630048|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630049|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630050|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630051|NCT01064687|O5|Outcome|Placebo/0.75 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630052|NCT01064687|O4|Outcome|Placebo/1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630053|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630054|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630251|NCT01064856|P1|Participant Flow|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630055|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630056|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630057|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630058|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630059|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630060|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630061|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630062|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630063|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630064|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630065|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630066|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630067|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630068|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630069|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630070|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630071|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630072|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630073|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630074|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630075|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630076|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630077|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630078|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630079|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630080|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630081|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
632557|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
630082|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630083|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630084|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630085|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630086|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630087|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630088|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630089|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630090|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630091|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630092|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630093|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630094|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630095|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630096|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630097|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630098|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630099|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630100|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630101|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630102|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630103|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630104|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630105|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630106|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630107|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630108|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
632558|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
630109|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630110|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630111|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630112|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630113|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630114|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630115|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630116|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630117|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630118|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630119|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630120|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630273|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630121|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630122|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630123|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630124|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630125|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630126|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630127|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630128|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630129|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630130|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630131|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630132|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630133|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630134|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630135|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630137|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630138|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630139|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630140|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630141|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630142|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630143|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630144|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630145|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630146|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630147|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630148|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630149|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630150|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks
Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
630151|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630152|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630153|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630154|NCT01064687|E9|Reported Event|Placebo/1.5 mg LY2189265 (26 Weeks Through 56 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
All events were treatment emergent during the LY2189265 treatment period."
630155|NCT01064687|E8|Reported Event|Placebo/0.75 mg LY2189265 (26 Weeks Through 56 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks
All events were treatment emergent during the LY2189265 treatment period."
630156|NCT01064687|E7|Reported Event|Exenatide (Baseline Through 56 Weeks)|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630157|NCT01064687|E6|Reported Event|1.5 mg LY2189265 (Baseline Through 56 Weeks)|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630158|NCT01064687|E5|Reported Event|0.75 mg LY2189265 (Baseline Through 56 Weeks)|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630159|NCT01064687|E4|Reported Event|Placebo (Baseline Through 26 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks
LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52)
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630160|NCT01064687|E3|Reported Event|Exenatide (Baseline Through 26 Weeks)|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630252|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
632559|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
630161|NCT01064687|E2|Reported Event|1.5 mg LY2189265 (Baseline Through 26 Weeks)|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630162|NCT01064687|E1|Reported Event|0.75 mg LY2189265 (Baseline Through 26 Weeks)|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks
Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
630163|NCT01064739|B1|Baseline|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630164|NCT01064739|P1|Participant Flow|Fixed Sodium Diet +/- Fava Beans|Participants consumed a fixed sodium diet on day 1 and the same diet plus 100g of fresh fava beans at breakfast and lunch on day 2.The 14 participants received both interventions.
630165|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630166|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630167|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630168|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630169|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
630326|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630170|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630171|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630172|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630173|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630174|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630175|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630176|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630177|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
630178|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630179|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630253|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630180|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630181|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
630182|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630183|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630184|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630185|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630186|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630187|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630188|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630189|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630190|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630191|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630192|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630193|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630194|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630195|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630196|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630254|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
632560|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
630197|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630198|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630199|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630200|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630201|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630202|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630203|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630274|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630204|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630205|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630206|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630207|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630208|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630209|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630210|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630211|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630212|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630213|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630214|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630215|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
630216|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630217|NCT01064739|E2|Reported Event|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
630218|NCT01064739|E1|Reported Event|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.
Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
630219|NCT01064817|B3|Baseline|Total|Total of all reporting groups
630220|NCT01064817|B2|Baseline|Placebo|"Placebo
Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630221|NCT01064817|B1|Baseline|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)
PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630222|NCT01064817|P2|Participant Flow|Placebo|"Placebo
Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630223|NCT01064817|P1|Participant Flow|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)
PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630323|NCT01065051|P2|Participant Flow|Placebo|Participants received a single oral dose of 1 mg placebo.
630225|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)
PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630226|NCT01064817|O2|Outcome|Placebo|"Placebo
Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630227|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)
PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630228|NCT01064817|O2|Outcome|Placebo|"Placebo
Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630229|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)
PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630230|NCT01064817|O2|Outcome|Placebo|"Placebo
Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630231|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)
PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630232|NCT01064817|E2|Reported Event|Placebo|"Placebo
Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630233|NCT01064817|E1|Reported Event|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)
PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
630234|NCT01064830|B3|Baseline|Total|Total of all reporting groups
630235|NCT01064830|B2|Baseline|Vehicle|apply to affected nails at night
630236|NCT01064830|B1|Baseline|Cyclosporine Solution|apply to affected nails at night
630237|NCT01064830|P2|Participant Flow|Vehicle (Refresh Dry Eye Therapy®)|Topical vehicle: Refresh Dry Eye Therapy® (ophthalmic solution of glycerin 1% and polysorbate 80 1%)
630238|NCT01064830|P1|Participant Flow|Cyclosporine Solution 0.05% (Restasis®)|Topical Cyclosporine 0.05% Ophthalmic Suspension
630239|NCT01064830|O2|Outcome|Vehicle|vehicle
630240|NCT01064830|O1|Outcome|Cyclosporine Solution|cyclosporine solution
630241|NCT01064830|O2|Outcome|Vehicle|topical
630242|NCT01064830|O1|Outcome|Cyclosporine Solution|topical
630243|NCT01064830|E2|Reported Event|Vehicle|topical
630244|NCT01064830|E1|Reported Event|Cyclosporine Solution|topical
630245|NCT01064856|B3|Baseline|Total|Total of all reporting groups
630246|NCT01064856|B2|Baseline|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630247|NCT01064856|B1|Baseline|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630248|NCT01064856|P4|Participant Flow|Double-blind Placebo / Open-label Adalimumab|Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
630249|NCT01064856|P3|Participant Flow|Double-blind Adalimumab / Open-label Adalimumab|Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.
630250|NCT01064856|P2|Participant Flow|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
632561|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
630255|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630256|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630257|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630258|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630259|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630260|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630261|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630262|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630263|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630264|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630265|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630266|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630267|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630268|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630269|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630270|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630271|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630272|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630275|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630276|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630277|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630278|NCT01064856|E3|Reported Event|Any Adalimumab|All randomized participants who had received at least 1 dose of adalimumab (blinded or open-label) at any time during the study (up to Week 156).
630279|NCT01064856|E2|Reported Event|Double-blind Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
630280|NCT01064856|E1|Reported Event|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
630281|NCT01064882|B4|Baseline|Total|Total of all reporting groups
630282|NCT01064882|B3|Baseline|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
630283|NCT01064882|B2|Baseline|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
630284|NCT01064882|B1|Baseline|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
630285|NCT01064882|P3|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
630286|NCT01064882|P2|Participant Flow|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
630287|NCT01064882|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
630288|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
630289|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
630290|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
630291|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
630292|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
630293|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
630294|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
630295|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
630296|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
630297|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
630298|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
630299|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
630300|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
630301|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
630302|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
632562|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
630304|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
630305|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
630306|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
630307|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
630308|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
630309|NCT01064882|E3|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
630310|NCT01064882|E2|Reported Event|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
630311|NCT01064882|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
630312|NCT01064947|B1|Baseline|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
630313|NCT01064947|P1|Participant Flow|All Participants|All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
630314|NCT01064947|O1|Outcome|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
630315|NCT01064947|O1|Outcome|Participants With a Positive Culture at Day 1|
630316|NCT01064947|O1|Outcome|Participants With Positive Culture at Day 1|
630317|NCT01064947|O2|Outcome|Participants With a Positive Culture at Day 1|
630318|NCT01064947|O1|Outcome|All Participants at Day 1|All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if necessary) for 7 days. The subject treatment site was cultured after 7 days of treatment.
630319|NCT01064947|E1|Reported Event|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
630320|NCT01065051|B3|Baseline|Total|Total of all reporting groups
630321|NCT01065051|B2|Baseline|Placebo|Participants received a single oral dose of 1 mg placebo.
630322|NCT01065051|B1|Baseline|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630328|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630329|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
630330|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630331|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
630332|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630333|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
630334|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630335|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
630336|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630337|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
630338|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630339|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
630340|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630341|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
630342|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630343|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
630344|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630345|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
630346|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630347|NCT01065051|E2|Reported Event|Placebo|Participants received a single oral dose of 1 mg placebo.
630348|NCT01065051|E1|Reported Event|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
630349|NCT01065350|B3|Baseline|Total|Total of all reporting groups
630350|NCT01065350|B2|Baseline|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose. One subject in the ketofol group was excluded from analysis due to incorrect study drug assignment and outside the protocol-specified dose."
630409|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630461|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630351|NCT01065350|B1|Baseline|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630352|NCT01065350|P2|Participant Flow|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630353|NCT01065350|P1|Participant Flow|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630354|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630355|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630356|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630357|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630358|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630359|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630360|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630361|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630362|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
632613|NCT01085045|E2|Reported Event|GP/FF MDI 36/9.6 μg|GP/FF MDI 36/9.6 μg (PT003)
630363|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630364|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630365|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630366|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630367|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630368|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630369|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630370|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630371|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630372|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630373|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630374|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630375|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630376|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630377|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630378|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630379|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630380|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630381|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630382|NCT01065350|E2|Reported Event|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
630383|NCT01065350|E1|Reported Event|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
630384|NCT01065428|B3|Baseline|Total|Total of all reporting groups
630385|NCT01065428|B2|Baseline|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
630386|NCT01065428|B1|Baseline|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
630387|NCT01065428|P2|Participant Flow|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
630388|NCT01065428|P1|Participant Flow|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
630389|NCT01065428|O2|Outcome|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
630390|NCT01065428|O1|Outcome|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
630391|NCT01065428|O2|Outcome|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
630392|NCT01065428|O1|Outcome|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
630393|NCT01065428|E2|Reported Event|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
630394|NCT01065428|E1|Reported Event|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
630395|NCT01065454|B5|Baseline|Total|Total of all reporting groups
630396|NCT01065454|B4|Baseline|Placebo|Participants received placebo tid.
630397|NCT01065454|B3|Baseline|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630398|NCT01065454|B2|Baseline|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630399|NCT01065454|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630400|NCT01065454|P4|Participant Flow|Placebo|Participants received placebo tid.
630401|NCT01065454|P3|Participant Flow|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630402|NCT01065454|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630403|NCT01065454|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630404|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630405|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630406|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630407|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630408|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630460|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630410|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630411|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630412|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630413|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630414|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630415|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630416|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630417|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630418|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630419|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630420|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630421|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630422|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630423|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630424|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630425|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630426|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630427|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630428|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630429|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630430|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630431|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630432|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630433|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630434|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630435|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630437|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630438|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630439|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630440|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630441|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630442|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630443|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630444|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630445|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630446|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630447|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630448|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630449|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630450|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630451|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630452|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630453|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630454|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630455|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630456|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630457|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630458|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630459|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630462|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630463|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630464|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630465|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630466|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630467|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630468|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630469|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630470|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630471|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630472|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630473|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630474|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630475|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630476|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630477|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630478|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630479|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630480|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630481|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630482|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630483|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630484|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630485|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630486|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630487|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630488|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630489|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630490|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630491|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630492|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630493|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630494|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630495|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630496|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630497|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630498|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630499|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630500|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630501|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630502|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630503|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630504|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
630505|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
630506|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
630507|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630508|NCT01065454|E4|Reported Event|Placebo|Participants received placebo tid
630509|NCT01065454|E3|Reported Event|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose)
630510|NCT01065454|E2|Reported Event|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg)
630538|NCT01065714|O1|Outcome|Skin Barrier Function With Eucerin Lotion|Measurement of TEWL on targeted area on one side of body treated with Eucerin Lotion
630511|NCT01065454|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
630512|NCT01065506|B3|Baseline|Total|Total of all reporting groups
630513|NCT01065506|B2|Baseline|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Aerobic Exercise: Aerobic Exercise"
630514|NCT01065506|B1|Baseline|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Wellness Program: Wellness Program"
630515|NCT01065506|P2|Participant Flow|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Aerobic Exercise: Aerobic Exercise thrice weekly (on a treadmill)"
630516|NCT01065506|P1|Participant Flow|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Wellness Program: Wellness Program consisting of thrice weekly sessions involving discussion of various wellness topics (e.g., diet, sun care, cancer prevention) and generating small wellness-related goals"
630517|NCT01065506|O2|Outcome|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Aerobic Exercise: Aerobic Exercise"
630518|NCT01065506|O1|Outcome|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Wellness Program: Wellness Program"
630519|NCT01065506|E2|Reported Event|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Aerobic Exercise: Aerobic Exercise"
630520|NCT01065506|E1|Reported Event|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Wellness Program: Wellness Program"
630521|NCT01065558|B1|Baseline|Ecopipam|
630522|NCT01065558|P1|Participant Flow|Ecopipam (12.5- 200 mg/Day)|"Patients were given ecopipapm over an 11 day period as follows:
day 1 12.5 mg/day day 2-3 25 mg/day day 4-5 50 mg/day day 6-9 100 mg/day day 9-11 200 mg/day
Note: Doses were reduced as necessary to a previously tolerated dose if paitents reached doses that were not safely tolerable."
630523|NCT01065558|O1|Outcome|Ecopipam Treated Patients|These were patients who had diagnoses Lesch-Nyhan Disease based either on their genetic changes or on changes of specific enzymes in their blood.
630524|NCT01065558|O1|Outcome|Ecopipam Treated Patients|These were patients who had diagnoses Lesch-Nyhan Disease based either on their genetic changes or on changes of specific enzymes in their blood.
630525|NCT01065558|E1|Reported Event|Ecopipam Treated Patients|
630526|NCT01065597|B1|Baseline|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy
Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
630556|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
631641|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
630527|NCT01065597|P1|Participant Flow|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy
Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
630528|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy
Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
630529|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy
Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
630530|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy
Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
630531|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy
Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
630532|NCT01065597|E1|Reported Event|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy
Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
630533|NCT01065714|B1|Baseline|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment
630534|NCT01065714|P1|Participant Flow|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment. Eucerin Lotion applied to one side of body, Hydrogel applied to the opposite side of body.
630535|NCT01065714|O1|Outcome|Skin Hydration With Hydrogel|Parallel designed study. Split body treatment. Hydrogel vehicle applied to targeted area one side of body. Skin Hydration measured by 5 Corneometer readings.
630536|NCT01065714|O1|Outcome|Skin Hydration With Eucerin|Parallel designed study. Split body treatment. Five corneometer readings were taken on the targeted area of one half of the body on which Eucerin Lotion was applied.
630537|NCT01065714|O1|Outcome|Skin Barrier Function With Hydrogel Vehicle|Trans epidural water loss measurements on target areas of body side treated with Hydrogel vehicle
630539|NCT01065714|E1|Reported Event|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment
630540|NCT01065766|B1|Baseline|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630541|NCT01065766|P1|Participant Flow|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630542|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630543|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630544|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630545|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630546|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630547|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630548|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630549|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630550|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630551|NCT01065766|E1|Reported Event|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
630552|NCT01065779|B1|Baseline|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
630553|NCT01065779|P1|Participant Flow|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
630554|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
630555|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
632614|NCT01085045|E1|Reported Event|GP/FF MDI 72/9.6 μg|GP/FF MDI 72/9.6 μg (PT003)
630557|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
630558|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
630559|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
630560|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
630561|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
630562|NCT01065779|E1|Reported Event|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
630563|NCT01065844|B1|Baseline|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday
Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
630564|NCT01065844|P1|Participant Flow|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday
Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
630565|NCT01065844|O1|Outcome|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday
Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
630566|NCT01065844|E1|Reported Event|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday
Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
630567|NCT01066000|B1|Baseline|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
630568|NCT01066000|P1|Participant Flow|Mircera|Eligible participants received methoxy polyethylene glycol-epoetin beta (Mircera) intravenously (IV), once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 microgram (mcg) which was based on the Epoetin dose of<8000, 8000-16000, or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
630569|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
630628|NCT01066520|E1|Reported Event|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
632563|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
630570|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
630571|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
630572|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
630573|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
630574|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
630575|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
630576|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
630577|NCT01066000|E1|Reported Event|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
630578|NCT01066039|B1|Baseline|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630579|NCT01066039|P1|Participant Flow|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 milligram (mg) once daily for 24 weeks. If the blood pressure was not less than 130/80 millimeter of mercury (mmHg) during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630607|NCT01066156|P1|Participant Flow|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
630580|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630581|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630582|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630583|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630584|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630585|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630586|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630587|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630588|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630589|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
631003|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
630590|NCT01066039|E1|Reported Event|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
630591|NCT01066104|B3|Baseline|Total|Total of all reporting groups
630592|NCT01066104|B2|Baseline|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
630593|NCT01066104|B1|Baseline|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
630594|NCT01066104|P2|Participant Flow|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
630595|NCT01066104|P1|Participant Flow|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
630596|NCT01066104|O2|Outcome|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
630597|NCT01066104|O1|Outcome|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
630598|NCT01066104|O2|Outcome|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
630599|NCT01066104|O1|Outcome|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
630600|NCT01066104|E2|Reported Event|Xolair (Omalizumab)|Xolair (omalizumab): two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
630601|NCT01066104|E1|Reported Event|Xolair Placebo|Xolair placebo: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
630602|NCT01066143|B1|Baseline|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
630603|NCT01066143|P1|Participant Flow|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
630604|NCT01066143|O1|Outcome|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
630605|NCT01066143|E1|Reported Event|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
630606|NCT01066156|B1|Baseline|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
630608|NCT01066156|O1|Outcome|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
630609|NCT01066156|E1|Reported Event|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
630610|NCT01066520|B4|Baseline|Total|Total of all reporting groups
630611|NCT01066520|B3|Baseline|Diclofenac Gel|Diclofenac Gel 2g, 3 times daily topical during 14 days
630612|NCT01066520|B2|Baseline|Traumeel S Gel|Traumeel S Gel 2g, 3 times daily topical during 14 days
630613|NCT01066520|B1|Baseline|Traumeel S Ointment|Traumeel S Ointment 2g, 3 times daily topical during 14 days
630614|NCT01066520|P3|Participant Flow|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630615|NCT01066520|P2|Participant Flow|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630616|NCT01066520|P1|Participant Flow|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630617|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630618|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630619|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630620|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630621|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630622|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630623|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630624|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630625|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630626|NCT01066520|E3|Reported Event|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630627|NCT01066520|E2|Reported Event|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
630629|NCT01066546|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
630630|NCT01066546|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
630631|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
630632|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
630633|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
630634|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
630635|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
630636|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
630637|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
630638|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
630639|NCT01066546|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
630640|NCT01066585|B3|Baseline|Total|Total of all reporting groups
630641|NCT01066585|B2|Baseline|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
630642|NCT01066585|B1|Baseline|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
630643|NCT01066585|P2|Participant Flow|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
630644|NCT01066585|P1|Participant Flow|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
630645|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
630646|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
630647|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
630648|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
630649|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
630650|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
630651|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
630652|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
630653|NCT01066585|E2|Reported Event|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
630654|NCT01066585|E1|Reported Event|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
630655|NCT01066624|B4|Baseline|Total|Total of all reporting groups
630656|NCT01066624|B3|Baseline|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.
Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
630657|NCT01066624|B2|Baseline|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
630658|NCT01066624|B1|Baseline|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.
0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
630679|NCT01066793|B1|Baseline|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630659|NCT01066624|P3|Participant Flow|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.
Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
630660|NCT01066624|P2|Participant Flow|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
630661|NCT01066624|P1|Participant Flow|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.
0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
630662|NCT01066624|O3|Outcome|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.
Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
630663|NCT01066624|O2|Outcome|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
630664|NCT01066624|O1|Outcome|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.
0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
630665|NCT01066624|E3|Reported Event|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.
Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
630666|NCT01066624|E2|Reported Event|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
630667|NCT01066624|E1|Reported Event|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.
0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
630668|NCT01066780|B1|Baseline|ClearVoice|
630669|NCT01066780|P2|Participant Flow|Group B: Received ClearVoice HIGH Followed by MEDIUM|Two week of chronic use of Clearvoice HIGH followed by two week of chronic use of ClearVoice MEDIUM.
630670|NCT01066780|P1|Participant Flow|Group A: Received ClearVoice MEDIUM Followed by HIGH|Two weeks of chronic use of ClearVoice MEDIUM followed by two week of chronic use of ClearVoice HIGH.
630671|NCT01066780|O1|Outcome|Group 1|Primary efficacy analyses were based on data from the 46 subjects that completed the study.
630672|NCT01066780|E1|Reported Event|Group 1|Primary efficacy analyses were based on data from the 46 subjects that completed the study.
630673|NCT01066793|B7|Baseline|Total|Total of all reporting groups
630674|NCT01066793|B6|Baseline|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630675|NCT01066793|B5|Baseline|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630676|NCT01066793|B4|Baseline|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630677|NCT01066793|B3|Baseline|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630678|NCT01066793|B2|Baseline|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630999|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
630680|NCT01066793|P6|Participant Flow|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630681|NCT01066793|P5|Participant Flow|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630682|NCT01066793|P4|Participant Flow|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630683|NCT01066793|P3|Participant Flow|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630684|NCT01066793|P2|Participant Flow|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630685|NCT01066793|P1|Participant Flow|Genotype 1 (G1)|Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received Pegasys® (Pegylated Interferon [PEG-IFN] alfa-2a) or PegIntron® (PEG-IFN alfa-2b) plus ribavirin dose according to the standard of care and in line with summary of product characteristics (SPCs)/local labeling for up to 72 weeks were observed.
630686|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630687|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630688|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630689|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630690|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630691|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630977|NCT01066871|P2|Participant Flow|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
630692|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630693|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630694|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630695|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630696|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630697|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630698|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630699|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630700|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630701|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630702|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630703|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV inclusive of all Genotypes who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630704|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
631000|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
630705|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630706|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630707|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630708|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630709|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630710|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630711|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630712|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630713|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630714|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630715|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630716|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
631693|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
630717|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630718|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630719|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630720|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630721|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630722|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630723|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630724|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630725|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630726|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630727|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630728|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630729|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630730|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
644898|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
630731|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630732|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630733|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630734|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630735|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630736|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630737|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630738|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630739|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630740|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630741|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630742|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630743|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630744|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630745|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630746|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630747|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630748|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630749|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630750|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630751|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630752|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630753|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630754|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630755|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630756|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
644899|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
630757|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630758|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630759|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630760|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630761|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630762|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630763|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630764|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630765|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630766|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630767|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630768|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630769|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630770|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630771|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630772|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630773|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630774|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630775|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630776|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630777|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630778|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630779|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630780|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630781|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630782|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
644900|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
630783|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630784|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630785|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630786|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630787|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630788|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630789|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630790|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630791|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630792|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630793|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630794|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630795|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630796|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630797|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630798|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630799|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630800|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630801|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630802|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630803|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630804|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630805|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630806|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630807|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630808|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
644901|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
630809|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630810|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630811|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630812|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630813|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630814|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630815|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630816|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630817|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630818|NCT01066793|E6|Reported Event|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630819|NCT01066793|E5|Reported Event|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630820|NCT01066793|E4|Reported Event|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630821|NCT01066793|E3|Reported Event|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630822|NCT01066793|E2|Reported Event|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630823|NCT01066793|E1|Reported Event|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
630824|NCT01066819|B7|Baseline|Total|Total of all reporting groups
630825|NCT01066819|B6|Baseline|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630826|NCT01066819|B5|Baseline|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630827|NCT01066819|B4|Baseline|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630828|NCT01066819|B3|Baseline|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630829|NCT01066819|B2|Baseline|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630830|NCT01066819|B1|Baseline|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630831|NCT01066819|P6|Participant Flow|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630832|NCT01066819|P5|Participant Flow|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630833|NCT01066819|P4|Participant Flow|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630834|NCT01066819|P3|Participant Flow|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
631001|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
630835|NCT01066819|P2|Participant Flow|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630836|NCT01066819|P1|Participant Flow|Genotype 1 (G1)|Eligible participants with serologically proven Chronic hepatitis C (CHC) (Genotype 1) who received Pegylated Interferon (PEG-IFN) alfa-2a (PEGASYS®) or PEG-IFN alfa-2b (PegIntron®) plus ribavirin for up to 48 weeks according to the standard of care and in line with summaries of product characteristics (SPCs)/local labeling were observed.
630837|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630838|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630839|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630840|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630841|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630842|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630843|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630844|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630845|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
631694|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
630846|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630847|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630848|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630849|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630850|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630851|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630852|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630853|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630854|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630855|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630856|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630857|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630858|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630859|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
631002|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
630860|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630861|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630862|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630863|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630864|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630865|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630866|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630867|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630868|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630869|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630870|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
633118|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
630871|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630872|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630873|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630874|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630875|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630876|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630877|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630878|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630879|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630880|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630881|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630882|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630883|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630884|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630885|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630886|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630887|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630888|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630889|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630890|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630891|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630892|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630893|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630894|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630895|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630896|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630897|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630898|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630899|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630900|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630901|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630902|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630903|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630904|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630905|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630906|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630907|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630908|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630909|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630910|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630911|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630912|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630913|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630914|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630915|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630916|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630917|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630918|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630919|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630920|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630921|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630922|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630923|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630924|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630925|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630926|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630927|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630928|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630929|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630930|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630931|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630932|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630933|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630934|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630935|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630936|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630937|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630938|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630939|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630940|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630941|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630942|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630943|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630944|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630945|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630946|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630947|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630948|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630949|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630950|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630951|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630952|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630953|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630954|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630955|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630956|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630957|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630958|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630959|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630960|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630961|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630962|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630963|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630964|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630965|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630966|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630967|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630968|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible Participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630969|NCT01066819|E1|Reported Event|Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b)|Eligible participants with serologically proven CHC who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
630970|NCT01066871|B5|Baseline|Total|Total of all reporting groups
630971|NCT01066871|B4|Baseline|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
630972|NCT01066871|B3|Baseline|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
630973|NCT01066871|B2|Baseline|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
630974|NCT01066871|B1|Baseline|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
630975|NCT01066871|P4|Participant Flow|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
630976|NCT01066871|P3|Participant Flow|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
631109|NCT01067339|O1|Outcome|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
630978|NCT01066871|P1|Participant Flow|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
630979|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
630980|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
630981|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
630982|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
630983|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
630984|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
630985|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
630986|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
630987|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
630988|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
630989|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
630990|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
630991|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
630992|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
630993|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
630994|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
630995|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
630996|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
630997|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
630998|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
631004|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
631005|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
631006|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
631007|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
631008|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
631009|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
631010|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
631011|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
631012|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
631013|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
631014|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
631015|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
631016|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
631017|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
631018|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
631019|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
631020|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
631021|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
631022|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
631023|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin AS902330 was administered as intra-articular injection once every week for 3 consecutive weeks.
631024|NCT01066871|O3|Outcome|AS902330 100 mcg|AS902330 was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
631025|NCT01066871|O2|Outcome|AS902330 30 mcg|AS902330 was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
631026|NCT01066871|O1|Outcome|AS902330 10 mcg|AS902330 was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
631027|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
631028|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
631029|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
631030|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
631031|NCT01066871|E4|Reported Event|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
631032|NCT01066871|E3|Reported Event|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
631033|NCT01066871|E2|Reported Event|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
631034|NCT01066871|E1|Reported Event|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
631035|NCT01066897|B3|Baseline|Total|Total of all reporting groups
631036|NCT01066897|B2|Baseline|Healthy Controls|Non depressed, non treatment comparison group from baseline
631037|NCT01066897|B1|Baseline|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.
Pramipexole: Patients will received increasing dose of pramipexole"
631038|NCT01066897|P2|Participant Flow|Healthy Controls|Non depressed, non treatment comparison group
631084|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631085|NCT01067105|E1|Reported Event|Ciclesonide|ciclesonide HFA 160 μg once daily
631039|NCT01066897|P1|Participant Flow|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.
Pramipexole: Patients will received increasing dose of pramipexole"
631040|NCT01066897|O2|Outcome|Healthy Controls|Non depressed, non treatment comparison group
631041|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.
Pramipexole: Patients will received increasing dose of pramipexole"
631042|NCT01066897|O2|Outcome|Healthy Controls|Non depressed, non-intervention comparison group
631043|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.
Pramipexole: Patients will received increasing dose of pramipexole"
631044|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.
Pramipexole: Patients will received increasing dose of pramipexole"
631045|NCT01066897|O2|Outcome|Healthy Controls Who Did Not Take Medication|
631046|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.
Pramipexole: Patients will received increasing dose of pramipexole"
631047|NCT01066897|E1|Reported Event|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.
Pramipexole: Patients will received increasing dose of pramipexole"
631048|NCT01066923|B5|Baseline|Total|Total of all reporting groups
631049|NCT01066923|B4|Baseline|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
Acute placebo: Placebo comparator for acute aspirin therapy"
631050|NCT01066923|B3|Baseline|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy"
631051|NCT01066923|B2|Baseline|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Passive cooling: Removing protective garments for passive cooling following exercise
Acute placebo: Placebo comparator for acute aspirin therapy"
631052|NCT01066923|B1|Baseline|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise"
631053|NCT01066923|P4|Participant Flow|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
Acute placebo: Placebo comparator for acute aspirin therapy"
631054|NCT01066923|P3|Participant Flow|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy"
631086|NCT01067326|B3|Baseline|Total|Total of all reporting groups
644902|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
631055|NCT01066923|P2|Participant Flow|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Passive cooling: Removing protective garments for passive cooling following exercise
Acute placebo: Placebo comparator for acute aspirin therapy"
631056|NCT01066923|P1|Participant Flow|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise"
631057|NCT01066923|O4|Outcome|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
Acute placebo: Placebo comparator for acute aspirin therapy"
631058|NCT01066923|O3|Outcome|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy"
631059|NCT01066923|O2|Outcome|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Passive cooling: Removing protective garments for passive cooling following exercise
Acute placebo: Placebo comparator for acute aspirin therapy"
631060|NCT01066923|O1|Outcome|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise"
631061|NCT01066923|O4|Outcome|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
Acute placebo: Placebo comparator for acute aspirin therapy"
631110|NCT01067339|E2|Reported Event|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
631812|NCT01075152|B1|Baseline|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis.
631062|NCT01066923|O3|Outcome|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy"
631063|NCT01066923|O2|Outcome|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Passive cooling: Removing protective garments for passive cooling following exercise
Acute placebo: Placebo comparator for acute aspirin therapy"
631064|NCT01066923|O1|Outcome|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise"
631065|NCT01066923|E4|Reported Event|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
Acute placebo: Placebo comparator for acute aspirin therapy"
631066|NCT01066923|E3|Reported Event|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy"
631067|NCT01066923|E2|Reported Event|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Passive cooling: Removing protective garments for passive cooling following exercise
Acute placebo: Placebo comparator for acute aspirin therapy"
631068|NCT01066923|E1|Reported Event|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise"
631069|NCT01067105|B1|Baseline|Ciclesonide|ciclesonide HFA 160 μg once daily
631070|NCT01067105|P1|Participant Flow|Ciclesonide|ciclesonide HFA 160 μg once daily
631071|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631072|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631073|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631074|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631075|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631076|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631077|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631078|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631079|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631080|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631081|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631082|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631083|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
631087|NCT01067326|B2|Baseline|Placebo|"1 pill per day by mouth for 4 months. Not all baseline data were available from started subjects, therefore only baseline data for completed subjects is presented."
631088|NCT01067326|B1|Baseline|Aliskiren|"150 mg Aliskiren once daily for a period of 4 months. Not all baseline data were available from started subjects, therefore only baseline data for completed subjects is presented."
631089|NCT01067326|P2|Participant Flow|Placebo|1 pill per day by mouth for 4 months.
631090|NCT01067326|P1|Participant Flow|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
631091|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
631092|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
631093|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
631094|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
631095|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
631096|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
631097|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
631098|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
631099|NCT01067326|E2|Reported Event|Placebo|1 pill per day by mouth for 4 months.
631100|NCT01067326|E1|Reported Event|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
631101|NCT01067339|B3|Baseline|Total|Total of all reporting groups
631102|NCT01067339|B2|Baseline|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
631103|NCT01067339|B1|Baseline|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
631104|NCT01067339|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
631105|NCT01067339|P1|Participant Flow|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
631106|NCT01067339|O2|Outcome|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
631107|NCT01067339|O1|Outcome|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
631108|NCT01067339|O2|Outcome|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
631111|NCT01067339|E1|Reported Event|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
631112|NCT01067352|B4|Baseline|Total|Total of all reporting groups
631113|NCT01067352|B3|Baseline|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631114|NCT01067352|B2|Baseline|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631115|NCT01067352|B1|Baseline|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
631116|NCT01067352|P3|Participant Flow|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631117|NCT01067352|P2|Participant Flow|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631118|NCT01067352|P1|Participant Flow|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
631119|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631120|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631121|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
631122|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631123|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631124|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
631125|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631158|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
631126|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631127|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
631128|NCT01067352|E3|Reported Event|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631129|NCT01067352|E2|Reported Event|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
631130|NCT01067352|E1|Reported Event|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
631131|NCT01067456|B3|Baseline|Total|Total of all reporting groups
631132|NCT01067456|B2|Baseline|Comprehensive Cardiothoracic CT Arm|"Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
Comprehensive Cardiothoracic Dual Source CT (DSCT) arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan."
631133|NCT01067456|B1|Baseline|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
631134|NCT01067456|P2|Participant Flow|Comprehensive Cardiothoracic CT Arm|Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
631135|NCT01067456|P1|Participant Flow|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
631136|NCT01067456|O2|Outcome|Comprehensive Cardiothoracic CT Arm|"Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
Comprehensive Cardiothoracic DSCT arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan."
631175|NCT01067781|B3|Baseline|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System"
631137|NCT01067456|O1|Outcome|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
631138|NCT01067456|E2|Reported Event|Comprehensive Cardiothoracic CT Arm|Subjects in this arm received a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
631139|NCT01067456|E1|Reported Event|Dedicated CT Arm|Subjects in this arm continued to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
631140|NCT01067716|B4|Baseline|Total|Total of all reporting groups
631141|NCT01067716|B3|Baseline|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
631142|NCT01067716|B2|Baseline|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
631143|NCT01067716|B1|Baseline|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
631144|NCT01067716|P3|Participant Flow|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
631145|NCT01067716|P2|Participant Flow|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
631146|NCT01067716|P1|Participant Flow|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
631147|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
631148|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
631149|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
631150|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
631151|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
631152|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
631153|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
631154|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
631155|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
631156|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
631157|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
644903|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
631159|NCT01067716|E3|Reported Event|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
631160|NCT01067716|E2|Reported Event|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
631161|NCT01067716|E1|Reported Event|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
631162|NCT01067768|B3|Baseline|Total|Total of all reporting groups
631163|NCT01067768|B2|Baseline|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
631164|NCT01067768|B1|Baseline|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
631165|NCT01067768|P2|Participant Flow|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
631166|NCT01067768|P1|Participant Flow|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
631167|NCT01067768|O2|Outcome|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
631168|NCT01067768|O1|Outcome|Daily Review|Daily monitoring of catheter indication
631169|NCT01067768|O2|Outcome|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
631170|NCT01067768|O1|Outcome|Daily Review|Daily monitoring of catheter indication
631171|NCT01067768|E2|Reported Event|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
631172|NCT01067768|E1|Reported Event|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
631173|NCT01067781|B5|Baseline|Total|Total of all reporting groups
631174|NCT01067781|B4|Baseline|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)
Placebo: Travelers' Diarrhea Vaccine System"
632126|NCT01075685|P2|Participant Flow|Minimum Information|
631176|NCT01067781|B2|Baseline|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
631177|NCT01067781|B1|Baseline|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
631178|NCT01067781|P4|Participant Flow|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)
Placebo: Travelers' Diarrhea Vaccine System"
631179|NCT01067781|P3|Participant Flow|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System"
631180|NCT01067781|P2|Participant Flow|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
631181|NCT01067781|P1|Participant Flow|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
631182|NCT01067781|O2|Outcome|Group 3 & 4 Combined: Placebo Patch (0µg LT)|with or without swabbing
631183|NCT01067781|O1|Outcome|Group 1 & 2 Combined: 37.5µg LT Patch|with or without swabbing
631184|NCT01067781|E4|Reported Event|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)
Placebo: Travelers' Diarrhea Vaccine System"
631185|NCT01067781|E3|Reported Event|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System"
631186|NCT01067781|E2|Reported Event|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
631187|NCT01067781|E1|Reported Event|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
631188|NCT01073267|B1|Baseline|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
631189|NCT01073267|P1|Participant Flow|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
631190|NCT01073267|O1|Outcome|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
631191|NCT01073267|E1|Reported Event|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
631192|NCT01073293|B3|Baseline|Total|Total of all reporting groups
631193|NCT01073293|B2|Baseline|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631194|NCT01073293|B1|Baseline|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
631195|NCT01073293|P2|Participant Flow|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631790|NCT01075087|E1|Reported Event|Placebo|"(control group) will receive sterile normal saline in the block
Placebo: Bilateral TAP block using sterile normal saline."
631791|NCT01075100|B3|Baseline|Total|Total of all reporting groups
631196|NCT01073293|P1|Participant Flow|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
631197|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631198|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
631199|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631200|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
631201|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631202|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
631203|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631204|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
631205|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631206|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
631207|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631208|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
631209|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631210|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
631211|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631212|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
631213|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631214|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
631215|NCT01073293|E2|Reported Event|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
631216|NCT01073293|E1|Reported Event|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Day 1
631217|NCT01073449|B1|Baseline|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
631218|NCT01073449|P1|Participant Flow|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
631219|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
631220|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
631221|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
631222|NCT01073449|E1|Reported Event|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
631223|NCT01073462|B1|Baseline|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
631792|NCT01075100|B2|Baseline|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631224|NCT01073462|P1|Participant Flow|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
631225|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
631226|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
631227|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
631228|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
631229|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
631230|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
631231|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
631232|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
631233|NCT01073462|E1|Reported Event|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years
631234|NCT01073930|B3|Baseline|Total|Total of all reporting groups
631235|NCT01073930|B2|Baseline|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631236|NCT01073930|B1|Baseline|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
631237|NCT01073930|P2|Participant Flow|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631238|NCT01073930|P1|Participant Flow|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
631239|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631240|NCT01073930|O1|Outcome|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
631241|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631242|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
631243|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631244|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
631245|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631246|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
631247|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631248|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
632564|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
631249|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631250|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
631251|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631252|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
631253|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631254|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
631255|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631256|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
631257|NCT01073930|E2|Reported Event|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631258|NCT01073930|E1|Reported Event|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
631259|NCT01073943|B3|Baseline|Total|Total of all reporting groups
631642|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
631260|NCT01073943|B2|Baseline|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631261|NCT01073943|B1|Baseline|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631262|NCT01073943|P2|Participant Flow|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631263|NCT01073943|P1|Participant Flow|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631264|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631265|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631266|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631267|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631268|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631269|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631270|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631271|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631272|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631273|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631793|NCT01075100|B1|Baseline|Triple Negative|ER-/PR-/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631274|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631275|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631276|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631277|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631278|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631279|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631280|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631281|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631282|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631283|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631284|NCT01073943|E2|Reported Event|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
631285|NCT01073943|E1|Reported Event|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
631286|NCT01074008|B10|Baseline|Total|Total of all reporting groups
631287|NCT01074008|B9|Baseline|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631288|NCT01074008|B8|Baseline|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631289|NCT01074008|B7|Baseline|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631290|NCT01074008|B6|Baseline|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631291|NCT01074008|B5|Baseline|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631292|NCT01074008|B4|Baseline|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631293|NCT01074008|B3|Baseline|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631294|NCT01074008|B2|Baseline|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631842|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
631295|NCT01074008|B1|Baseline|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631296|NCT01074008|P9|Participant Flow|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631297|NCT01074008|P8|Participant Flow|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631298|NCT01074008|P7|Participant Flow|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631299|NCT01074008|P6|Participant Flow|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631300|NCT01074008|P5|Participant Flow|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631414|NCT01074034|O1|Outcome|AV Therapy Assessment Group|"appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device
AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device"
631301|NCT01074008|P4|Participant Flow|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631302|NCT01074008|P3|Participant Flow|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631303|NCT01074008|P2|Participant Flow|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631304|NCT01074008|P1|Participant Flow|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631305|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631306|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631307|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631308|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631309|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631310|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631843|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
631311|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631312|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631313|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631314|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631315|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631316|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631317|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631318|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631319|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631320|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631321|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631322|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631323|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631324|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631325|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631326|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631794|NCT01075100|P2|Participant Flow|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631327|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631328|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631329|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631330|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631331|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631332|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631333|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631334|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631335|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631336|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631337|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631338|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631339|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631340|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631341|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631342|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631597|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631343|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631344|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631345|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631346|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631347|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631348|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
632127|NCT01075685|P1|Participant Flow|Web-based Alcohol Programme|
631349|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631350|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631351|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631352|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631353|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631354|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631355|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631356|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631357|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631358|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631407|NCT01074008|E4|Reported Event|ABT-072 (100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631359|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631360|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631361|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631362|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631363|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631415|NCT01074034|E1|Reported Event|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
631416|NCT01074047|B3|Baseline|Total|Total of all reporting groups
631364|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631365|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631366|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631367|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631368|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631369|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631370|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631371|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631372|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631373|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631374|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631375|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631376|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631377|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631378|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631379|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631643|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
631380|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631381|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631382|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631383|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631384|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631385|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631386|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631387|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631388|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631389|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631390|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631520|NCT01074125|E3|Reported Event|8g/Day|Participants received 8g tablet of KRX-0502 (ferric citrate) for 4 weeks
631521|NCT01074125|E2|Reported Event|6g/Day|Participants received 6g tablet of KRX-0502 (ferric citrate) for 4 weeks
631391|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631392|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631393|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631394|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631395|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631396|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631397|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631398|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631399|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631400|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631401|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631402|NCT01074008|E9|Reported Event|Placebo + (pegIFN/RBV)|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631403|NCT01074008|E8|Reported Event|ABT-333 (800 mg) Twice Daily (BID) + (pegIFN/RBV)|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631404|NCT01074008|E7|Reported Event|ABT-333 (400 mg) Twice a Day (BID) + (pegIFN/RBV)|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631405|NCT01074008|E6|Reported Event|ABT-072 (600 mg) Once Daily (QD) + (pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631406|NCT01074008|E5|Reported Event|ABT-072 (300 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631522|NCT01074125|E1|Reported Event|1g/Day|Participants received 1g tablet of KRX-0502 (ferric citrate) for 4 weeks
631523|NCT01074164|B3|Baseline|Total|Total of all reporting groups
631408|NCT01074008|E3|Reported Event|ABT-450/r (200/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631409|NCT01074008|E2|Reported Event|ABT-450/r (100/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631410|NCT01074008|E1|Reported Event|ABT-450/r (50/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
631411|NCT01074034|B1|Baseline|AV Therapy Assessment Group|"AV Therapy Assessment group, Atrial ATP and Atrial Therapy Suite (ATS)
AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
Ventricular tachyarrhythmia rescue shock feature
AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device"
631412|NCT01074034|P1|Participant Flow|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
631413|NCT01074034|O1|Outcome|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
632128|NCT01075685|O2|Outcome|Minimum Information|
631417|NCT01074047|B2|Baseline|Conventional Care Regimens (CCR)|#1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. Consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed. # 2 Low-dose cytarabine 20 mg SC twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only includes transfusion of blood products, antibiotics, antifungals and nutritional help.
631418|NCT01074047|B1|Baseline|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631419|NCT01074047|P2|Participant Flow|Conventional Care Regimens (CCR)|"CCRs included:
1 Intensive Chemotherapy: Cytarabine 100-200 mg/m2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m² QD or Idarubicin 9-12 mg/m² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed
2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC
3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
631420|NCT01074047|P1|Participant Flow|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631421|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631422|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631423|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631524|NCT01074164|B2|Baseline|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
631424|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631425|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631426|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631427|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631644|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
631428|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631429|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631430|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631431|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631432|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631433|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631525|NCT01074164|B1|Baseline|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
631526|NCT01074164|P2|Participant Flow|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
631527|NCT01074164|P1|Participant Flow|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
631434|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631435|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631436|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631437|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631438|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631439|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631440|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631441|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631442|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631443|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631528|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
631529|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
631673|NCT01074554|P1|Participant Flow|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
632565|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
631444|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631445|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631446|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631447|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631448|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631449|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631450|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631451|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631452|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631453|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631530|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
631531|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
631674|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
631844|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
631454|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631455|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631456|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631457|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631458|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631459|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631460|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631461|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631462|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631463|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631532|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
631533|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
631750|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631464|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631465|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631466|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631581|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631467|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631468|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631469|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631470|NCT01074047|O4|Outcome|Conventional Care Regimen #1 Intensive Chemotherapy|Induction Therapy included Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (IV) for 7 days plus daunorubicin 45 to 60 mg/m^² daily IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV daily for 3 days as an alternative to daunorubicin (Cycle 1). Consolidation Therapy (Cycle 2 and 3) Cytarabine 100-200 mg/m^2 as a continuous IV infusion for a total of 3 to 7 days plus daunorubicin 45 to 60 mg/m^² daily or Idarubicin 9-12 mg/m^² IV daily on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from commencement of induction therapy, upon recovery of absolute neutrophil count (ANC) to at least 1.0 x 10^9/L and platelets to at least 75 x 10^9/L. The second consolidation cycle, if given, started between Day 28 and Day 70 from commencement of the first consolidation therapy. Participants could receive BSC as needed, including antibiotics and transfusions, physicians discretion.
631471|NCT01074047|O3|Outcome|Conventional Care Regimen #2 Low-dose Cytarabine|Low-dose cytarabine 20 mg SC injection twice a day (BID) for 10 days, every 28 days (optimally for at least 4 cycles) until the end of the study, unless participants were discontinued from the treatment. Best supportive care as needed, including antibiotics and transfusions, per physicians discretion.
631472|NCT01074047|O2|Outcome|Conventional Care Regimen #3 Best Supportive Care Only|Best supportive care included red blood cell (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic and/or antifungal therapy, and nutritional support.
631473|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631474|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631475|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631795|NCT01075100|P1|Participant Flow|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631476|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631477|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631478|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
632129|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
631479|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631480|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631481|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631482|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631483|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631484|NCT01074047|O2|Outcome|Conventional Care Regimen|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631485|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631534|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
631535|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
631751|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631486|NCT01074047|O2|Outcome|Conventional Care Regimens (CCR)|CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
631487|NCT01074047|O1|Outcome|Azacitidine (AZA)|Azacitidine 75 mg/m2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631488|NCT01074047|E5|Reported Event|Azacitidine-extension|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
631540|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
631541|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
631489|NCT01074047|E4|Reported Event|Intensive Chemotherapy|Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed
631490|NCT01074047|E3|Reported Event|Low-dose Cytarabine|Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC
631491|NCT01074047|E2|Reported Event|BSC Only|Transfusion of blood products, antibiotics, antifungals and nutritional help
631492|NCT01074047|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion
631493|NCT01074099|B3|Baseline|Total|Total of all reporting groups
631494|NCT01074099|B2|Baseline|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery
BMAC: Injection of BMAC into ischemic myocardium during CABG"
631495|NCT01074099|B1|Baseline|Control|"CABG only
CABG only: Control subjects will undergo CABG surgery without BMAC injection"
631496|NCT01074099|P2|Participant Flow|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery
BMAC: Injection of BMAC into ischemic myocardium during CABG"
631497|NCT01074099|P1|Participant Flow|Control|"CABG only
CABG only: Control subjects will undergo CABG surgery without BMAC injection"
631498|NCT01074099|O2|Outcome|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery
BMAC: Injection of BMAC into ischemic myocardium during CABG"
631499|NCT01074099|O1|Outcome|Control|"CABG only
CABG only: Control subjects will undergo CABG surgery without BMAC injection"
631500|NCT01074099|O2|Outcome|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery
BMAC: Injection of BMAC into ischemic myocardium during CABG"
631501|NCT01074099|O1|Outcome|Control|"CABG only
CABG only: Control subjects will undergo CABG surgery without BMAC injection"
631502|NCT01074099|E2|Reported Event|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery
BMAC: Injection of BMAC into ischemic myocardium during CABG"
631503|NCT01074099|E1|Reported Event|Control|"CABG only
CABG only: Control subjects will undergo CABG surgery without BMAC injection"
631504|NCT01074125|B4|Baseline|Total|Total of all reporting groups
631505|NCT01074125|B3|Baseline|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
631506|NCT01074125|B2|Baseline|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
631507|NCT01074125|B1|Baseline|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
631508|NCT01074125|P3|Participant Flow|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
631509|NCT01074125|P2|Participant Flow|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
631510|NCT01074125|P1|Participant Flow|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
631511|NCT01074125|O3|Outcome|8 g/Day|"8 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
631512|NCT01074125|O2|Outcome|6 g/Day|"6 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
631513|NCT01074125|O1|Outcome|1 g/Day|"1 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
631514|NCT01074125|O3|Outcome|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
631515|NCT01074125|O2|Outcome|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
631516|NCT01074125|O1|Outcome|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
631517|NCT01074125|O3|Outcome|8 g/Day|"8 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
631518|NCT01074125|O2|Outcome|6 g/Day|"6 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
631519|NCT01074125|O1|Outcome|1 g/Day|"1 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
632566|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
631536|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
631537|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
631538|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
631539|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
631580|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631542|NCT01074164|E2|Reported Event|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
631543|NCT01074164|E1|Reported Event|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
631544|NCT01074216|B1|Baseline|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
631545|NCT01074216|P1|Participant Flow|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
631546|NCT01074216|O1|Outcome|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
631547|NCT01074216|E1|Reported Event|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
631548|NCT01074229|B4|Baseline|Total|Total of all reporting groups
631549|NCT01074229|B3|Baseline|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
631550|NCT01074229|B2|Baseline|Study Drug|Group A (study group) 20 cc of 0.5% ropivacaine
631551|NCT01074229|B1|Baseline|Placebo|Group B (control group) will receive sterile normal saline.
631552|NCT01074229|P3|Participant Flow|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
631553|NCT01074229|P2|Participant Flow|20 cc of 0.5% Ropivacaine|Group A (study group) 20 cc of 0.5% ropivacaine
631554|NCT01074229|P1|Participant Flow|Placebo|Group B (control group) will receive sterile normal saline.
631555|NCT01074229|O3|Outcome|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
631556|NCT01074229|O2|Outcome|20 cc of 0.5% Ropivacaine|Group A (study group) 20 cc of 0.5% ropivacaine
631557|NCT01074229|O1|Outcome|Placebo|Group B (control group) will receive sterile normal saline.
631558|NCT01074229|O3|Outcome|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
631559|NCT01074229|O2|Outcome|20 cc of 0.5% Ropivacaine|STUDY DRUG Group A (study group) 20 cc of 0.5% ropivacaine
631560|NCT01074229|O1|Outcome|PLACEBO|Group B (control group) will receive sterile normal saline.
631561|NCT01074229|E3|Reported Event|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
631562|NCT01074229|E2|Reported Event|Study Drug|Group A (study group) 20 cc of 0.5% ropivacaine
631563|NCT01074229|E1|Reported Event|Placebo|Group B (control group) will receive sterile normal saline.
631564|NCT01074242|B1|Baseline|Rotateq|Korean infants vaccinated with Rotateq in usual practice
631565|NCT01074242|P1|Participant Flow|Rotateq|Korean infants vaccinated with Rotateq in usual practice
631566|NCT01074242|O1|Outcome|Rotateq|Korean infants vaccinated with Rotateq in usual practice
631567|NCT01074242|O1|Outcome|Rotateq|Korean infants vaccinated with Rotateq in usual practice
631568|NCT01074242|E1|Reported Event|Rotateq|Korean infants vaccinated with Rotateq in usual practice
631569|NCT01074255|B1|Baseline|Korean Participants Treated With EMEND (Aprepitant)|EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
631570|NCT01074255|P1|Participant Flow|Korean Participants Treated With EMEND (Aprepitant)|EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
631571|NCT01074255|O1|Outcome|Participants Treated With EMEND|
631572|NCT01074255|E1|Reported Event|Participants in the Safety Analysis|Participants included in the Safety Analysis
631573|NCT01074268|B3|Baseline|Total|Total of all reporting groups
631574|NCT01074268|B2|Baseline|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631575|NCT01074268|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631576|NCT01074268|P2|Participant Flow|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631577|NCT01074268|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631578|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631579|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
632130|NCT01075685|O2|Outcome|Minimum Information|
631582|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631583|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631584|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631585|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631586|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631587|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631588|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631589|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631590|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631591|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631592|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631593|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631594|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631595|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631596|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631788|NCT01075087|O1|Outcome|Placebo|"(control group) will receive sterile normal saline in the block
Placebo: Bilateral TAP block using sterile normal saline."
632567|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
631598|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631599|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631600|NCT01074268|E2|Reported Event|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631601|NCT01074268|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
631602|NCT01074307|B3|Baseline|Total|Total of all reporting groups
631603|NCT01074307|B2|Baseline|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631604|NCT01074307|B1|Baseline|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631639|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
631640|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
631605|NCT01074307|P2|Participant Flow|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631606|NCT01074307|P1|Participant Flow|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631607|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631608|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631609|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631610|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631611|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631612|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631613|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631614|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631615|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631675|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.
All four drugs are given concomitantly."
631616|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631617|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631618|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631619|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631620|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631621|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631622|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631623|NCT01074307|E2|Reported Event|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631624|NCT01074307|E1|Reported Event|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
631625|NCT01074437|B3|Baseline|Total|Total of all reporting groups
631626|NCT01074437|B2|Baseline|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
631627|NCT01074437|B1|Baseline|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
631628|NCT01074437|P2|Participant Flow|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
631629|NCT01074437|P1|Participant Flow|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
631630|NCT01074437|O2|Outcome|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
631631|NCT01074437|O1|Outcome|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
631676|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
631632|NCT01074437|E2|Reported Event|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
631633|NCT01074437|E1|Reported Event|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
631634|NCT01074450|B3|Baseline|Total|Total of all reporting groups
631635|NCT01074450|B2|Baseline|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
631636|NCT01074450|B1|Baseline|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
631637|NCT01074450|P2|Participant Flow|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
631638|NCT01074450|P1|Participant Flow|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
632131|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
631645|NCT01074450|E2|Reported Event|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
631646|NCT01074450|E1|Reported Event|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
631647|NCT01074463|B3|Baseline|Total|Total of all reporting groups
631648|NCT01074463|B2|Baseline|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
631649|NCT01074463|B1|Baseline|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
631650|NCT01074463|P2|Participant Flow|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
631651|NCT01074463|P1|Participant Flow|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
631652|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
631653|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
631654|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
631655|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
631656|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
631657|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
631658|NCT01074463|E2|Reported Event|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
631659|NCT01074463|E1|Reported Event|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
631660|NCT01074502|B1|Baseline|Apremilast|apremilast 20 mgs twice a day for 12 weeks
631661|NCT01074502|P1|Participant Flow|Apremilast|apremilast 20 mgs twice a day for 12 weeks
631662|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
631663|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
631664|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
631665|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
631666|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
631667|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
631668|NCT01074502|E1|Reported Event|Apremilast|apremilast 20 mgs twice a day for 12 weeks
631669|NCT01074554|B3|Baseline|Total|Total of all reporting groups
631670|NCT01074554|B2|Baseline|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
631671|NCT01074554|B1|Baseline|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
631672|NCT01074554|P2|Participant Flow|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
631677|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.
All four drugs are given concomitantly."
631678|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
631679|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.
All four drugs are given concomitantly."
631680|NCT01074554|E2|Reported Event|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
631681|NCT01074554|E1|Reported Event|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
631682|NCT01074658|B1|Baseline|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
631683|NCT01074658|P1|Participant Flow|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
631684|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
631685|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
631686|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
631687|NCT01074658|E1|Reported Event|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
631688|NCT01074931|B1|Baseline|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
631689|NCT01074931|P1|Participant Flow|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
631690|NCT01074931|O2|Outcome|Lopinavir/Ritonavir Group: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
631691|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
631692|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
632132|NCT01075685|O2|Outcome|Minimum Information|
631695|NCT01074931|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
631696|NCT01074931|O1|Outcome|Lopinavir/Ritonavir: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
631697|NCT01074931|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
631698|NCT01074931|O1|Outcome|Lopinavir/Ritonavir: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
631699|NCT01074931|E1|Reported Event|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
631700|NCT01074944|B1|Baseline|All Participants|All participants who received treatment in LIP (eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID [50 or 100 mg capsules] based on their individual PK data for up to 78 weeks [except for the participants in Japan]. Participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID [50 or 100 mg capsules] based on their individual PK data for up to 78 weeks) and assessed for randomization.
631701|NCT01074944|P5|Participant Flow|ETP, Eliglustat|All participants who did not meet all the randomization criteria at Week 78 of the LIP continued in the ETP and received eliglustat capsules at the same dose as they were receiving at the end of LIP till the end of the study.
631702|NCT01074944|P4|Participant Flow|LTTP, Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631703|NCT01074944|P3|Participant Flow|PAP, Eliglustat: Twice Daily|All participants who were randomized after meeting all randomization criteria (defined as: no more than 1 bone crisis and was free of other clinically symptomatic bone disease [such as bone pain attributable to osteonecrosis and/or pathological fractures) during the first 6 months of the LIP; mean hemoglobin level of ≥11 g/dL [if female] and ≥12 g/dL [if male]; mean platelet count ≥100,000/mm^3; spleen volume ≤10 times of normal; liver volume ≤1.5 times of normal; had a dose of 50 mg BID or 100 mg BID of eliglustat for at least 4 months and a peak (2-hour) Genz-99067 plasma concentration of <50 ng/mL) after either 26, 52 or 78 weeks of LIP, received eliglustat at the TDD 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631704|NCT01074944|P2|Participant Flow|PAP, Eliglustat: Once Daily|All participants who were randomized after meeting all randomization criteria (defined as: no more than 1 bone crisis and was free of other clinically symptomatic bone disease [such as bone pain attributable to osteonecrosis and/or pathological fractures) during the first 6 months of the LIP; mean hemoglobin level of ≥11 g/dL [if female] and ≥12 g/dL [if male]; mean platelet count ≥100,000/mm^3; spleen volume ≤10 times of normal; liver volume ≤1.5 times of normal; had a dose of 50 mg BID or 100 mg BID of eliglustat for at least 4 months and a peak (2-hour) Genz-99067 plasma concentration of <50 ng/mL) after either 26, 52 or 78 weeks of LIP received eliglustat capsules at the total daily dose (TDD) of 100 mg or 200 mg (the TDD they were on before randomization) once daily (QD) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631705|NCT01074944|P1|Participant Flow|LIP, Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual pharmacokinetics (PK) data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
631706|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631707|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631730|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631731|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631766|NCT01075074|O2|Outcome|Normal Saline|The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
631708|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631709|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631710|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631711|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631712|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631749|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631713|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631714|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631732|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631767|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
631715|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631716|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
631717|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
631718|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
631719|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
631720|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
631721|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
631722|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
631723|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
631724|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
632568|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
631725|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
631726|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
631727|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631728|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631729|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631765|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
631733|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631734|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631735|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631736|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631737|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631738|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631739|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631740|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631741|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631742|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631743|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631744|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631745|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631746|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631747|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631748|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631789|NCT01075087|E2|Reported Event|Active Comparator|(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
631752|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631753|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631754|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631755|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631756|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
631757|NCT01074944|E1|Reported Event|Eliglustat|All participants who received eliglustat at the TDD of 100 mg or 200 mg in the LIP, PAP, LTTP or ETP.
631758|NCT01075074|B4|Baseline|Total|Total of all reporting groups
631759|NCT01075074|B3|Baseline|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
631760|NCT01075074|B2|Baseline|Normal Saline|Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
631761|NCT01075074|B1|Baseline|Ropivacaine 0.05%|Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
631762|NCT01075074|P3|Participant Flow|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
631763|NCT01075074|P2|Participant Flow|Normal Saline|Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
631764|NCT01075074|P1|Participant Flow|Ropivacaine 0.05%|Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
631768|NCT01075074|O3|Outcome|Ropivacaine 0.25%|Ropivicaine 0.25% group will receive a bilateral transversus abdominis plane block using 15 cc of 0.25% ropivacaine on each side
631769|NCT01075074|O2|Outcome|Normal Saline|Normal saline group will receive a bilateral transversus abdominis plane block 15 cc of sterile normal saline.
631770|NCT01075074|O1|Outcome|Ropivacaine 0.5%|Ropivacaine 0.5% group will receive a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side
631771|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
631772|NCT01075074|O2|Outcome|Normal Saline|The normal saline group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
631773|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
631774|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
631775|NCT01075074|O2|Outcome|Normal Saline|The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
631776|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
631777|NCT01075074|E3|Reported Event|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivicaine 0.25%
631778|NCT01075074|E2|Reported Event|Normal Saline|Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.
631779|NCT01075074|E1|Reported Event|Ropivacaine 0.5%|Subjects received a bilateral transversus abdominis plane block using 15 cc of 0.5% ropivacaine
631780|NCT01075087|B3|Baseline|Total|Total of all reporting groups
631781|NCT01075087|B2|Baseline|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
631782|NCT01075087|B1|Baseline|Placebo|"(control group) will receive sterile normal saline in the block
Placebo: Bilateral TAP block using sterile normal saline."
631783|NCT01075087|P2|Participant Flow|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
631784|NCT01075087|P1|Participant Flow|Placebo|"(control group) will receive sterile normal saline in the block
Placebo: Bilateral TAP block using sterile normal saline."
631785|NCT01075087|O2|Outcome|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
631786|NCT01075087|O1|Outcome|Placebo|"(control group) will receive sterile normal saline in the block
Placebo: Bilateral TAP block using sterile normal saline."
631787|NCT01075087|O2|Outcome|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
632569|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
631796|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631797|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631798|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631799|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631800|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631801|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631802|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631803|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631804|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631805|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631806|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631807|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631808|NCT01075100|E2|Reported Event|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631809|NCT01075100|E1|Reported Event|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
631810|NCT01075152|B3|Baseline|Total|Total of all reporting groups
631811|NCT01075152|B2|Baseline|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/- 1 week)
631813|NCT01075152|P2|Participant Flow|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/1 week)
631814|NCT01075152|P1|Participant Flow|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal diagnosis
631815|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
631816|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
631817|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
631818|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
631819|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
631820|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
631821|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
631822|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis]
631823|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
631824|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
631825|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
631826|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
631827|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
631828|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
631829|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
631830|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
631831|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
631832|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
631833|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week).
631834|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
631835|NCT01075152|E2|Reported Event|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
631836|NCT01075152|E1|Reported Event|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
631837|NCT01075178|B3|Baseline|Total|Total of all reporting groups
631838|NCT01075178|B2|Baseline|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
631839|NCT01075178|B1|Baseline|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
631840|NCT01075178|P2|Participant Flow|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
631841|NCT01075178|P1|Participant Flow|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
631845|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
631846|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
631847|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
631848|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
631849|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
631850|NCT01075178|E2|Reported Event|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
631851|NCT01075178|E1|Reported Event|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
631852|NCT01075191|B1|Baseline|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.
Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
631853|NCT01075191|P1|Participant Flow|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.
Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
631854|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.
Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
631855|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.
Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
631856|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.
Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
631857|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.
Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
631858|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.
Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
632133|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
631859|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.
Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
631860|NCT01075191|E1|Reported Event|HIV-infected Participants|"HIV-infected patients taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.
Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily).
Safety data presents all enrolled participants, including 5 protocol violations."
631861|NCT01075204|B1|Baseline|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631862|NCT01075204|P1|Participant Flow|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631863|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631864|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631865|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631866|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631867|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631868|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631869|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631870|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631871|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631872|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
632570|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
631873|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631874|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631875|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631876|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631877|NCT01075204|E1|Reported Event|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
631878|NCT01075217|B3|Baseline|Total|Total of all reporting groups
631879|NCT01075217|B2|Baseline|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631880|NCT01075217|B1|Baseline|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631881|NCT01075217|P2|Participant Flow|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631882|NCT01075217|P1|Participant Flow|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631883|NCT01075217|O2|Outcome|Visipaque 270 Quality of Opacification After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
632134|NCT01075685|O2|Outcome|Minimum Information|
631884|NCT01075217|O1|Outcome|Isovue 250 Quality of Opacification After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631885|NCT01075217|O2|Outcome|Visipaque 270 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631886|NCT01075217|O1|Outcome|Isovue 250 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631887|NCT01075217|O2|Outcome|Visipaque 270 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631888|NCT01075217|O1|Outcome|Isovue 250 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631889|NCT01075217|O2|Outcome|Visipaque 270 VAS Score Immedicately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631890|NCT01075217|O1|Outcome|Isovue 250 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631891|NCT01075217|O4|Outcome|Visipaque 270 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631892|NCT01075217|O3|Outcome|Visipaque 270 VAS Score Prior to Injection (Baseline)|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631893|NCT01075217|O2|Outcome|Isovue 250 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631894|NCT01075217|O1|Outcome|Isovue 250 VAS Score Prior to Injection (Baseline)|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631895|NCT01075217|E2|Reported Event|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631896|NCT01075217|E1|Reported Event|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
631897|NCT01075243|B4|Baseline|Total|Total of all reporting groups
631898|NCT01075243|B3|Baseline|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631899|NCT01075243|B2|Baseline|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631900|NCT01075243|B1|Baseline|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
631901|NCT01075243|P3|Participant Flow|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631902|NCT01075243|P2|Participant Flow|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631903|NCT01075243|P1|Participant Flow|Paracetamol Caplet 1000 Milligrams (mg)|Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 milliliter (mL) of water through oral route.
631904|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631905|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631906|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
631907|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631908|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631909|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
632135|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
631910|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631911|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631912|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
631913|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631914|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631915|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
631916|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631917|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631918|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
631919|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631920|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631921|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
631922|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631923|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631924|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
631925|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631926|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631927|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
631928|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631929|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631930|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
631931|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631932|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631933|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
631934|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631935|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631936|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
631937|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631938|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631939|NCT01075243|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
631940|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631941|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631942|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
631943|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
632136|NCT01075685|E2|Reported Event|Minimum Information|
631944|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631945|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
631946|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631947|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631948|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
631949|NCT01075243|E3|Reported Event|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
631950|NCT01075243|E2|Reported Event|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
631951|NCT01075243|E1|Reported Event|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
631952|NCT01075256|B4|Baseline|Total|Total of all reporting groups
631953|NCT01075256|B3|Baseline|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
631954|NCT01075256|B2|Baseline|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631955|NCT01075256|B1|Baseline|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631956|NCT01075256|P3|Participant Flow|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
631957|NCT01075256|P2|Participant Flow|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631958|NCT01075256|P1|Participant Flow|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631959|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
631960|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631961|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631962|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
644904|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
631963|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631964|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631965|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
631966|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631967|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631968|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate (NovaMin) free placebo toothpaste. All study treatments were fluoride free.
631969|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631970|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631971|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
631972|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631973|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631974|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
632137|NCT01075685|E1|Reported Event|Web-based Alcohol Programme|
632138|NCT01075763|B3|Baseline|Total|Total of all reporting groups
631975|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631976|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631977|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
631978|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631979|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631980|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
631981|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631982|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631983|NCT01075256|E3|Reported Event|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
631984|NCT01075256|E2|Reported Event|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631985|NCT01075256|E1|Reported Event|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
631986|NCT01075282|B4|Baseline|Total|Total of all reporting groups
631987|NCT01075282|B3|Baseline|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
631988|NCT01075282|B2|Baseline|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
631989|NCT01075282|B1|Baseline|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
631990|NCT01075282|P3|Participant Flow|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
631991|NCT01075282|P2|Participant Flow|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
631992|NCT01075282|P1|Participant Flow|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
644905|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
631993|NCT01075282|O1|Outcome|LY2189265 1.5 mg and 0.75 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg, subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
631994|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
631995|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
631996|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
631997|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
631998|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
631999|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632000|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632001|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632002|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
633119|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
632003|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632004|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632005|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632006|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632007|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632008|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632009|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632010|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632011|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632012|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632013|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632014|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632015|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632016|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632017|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632018|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632019|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632020|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632021|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632022|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632023|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632024|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632025|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632026|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632027|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632028|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632029|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632030|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632031|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632032|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632033|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632034|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632035|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632036|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632037|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632038|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632039|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632040|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632041|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632042|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632043|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632044|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632045|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632046|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632047|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632048|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632049|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632050|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632051|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632052|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632053|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632054|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632055|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632056|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632057|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632058|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632059|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632060|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632061|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632062|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632063|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632064|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632065|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632066|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632067|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632068|NCT01075282|E3|Reported Event|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632069|NCT01075282|E2|Reported Event|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632070|NCT01075282|E1|Reported Event|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks"
632071|NCT01075347|B3|Baseline|Total|Total of all reporting groups
632072|NCT01075347|B2|Baseline|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
632073|NCT01075347|B1|Baseline|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
632074|NCT01075347|P2|Participant Flow|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
632075|NCT01075347|P1|Participant Flow|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
632459|NCT01070693|P1|Participant Flow|Prolene Hernia System Device|Inguinal hernia repair either with a bilayer mesh (PHS)
632076|NCT01075347|O2|Outcome|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
632077|NCT01075347|O1|Outcome|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
632078|NCT01075347|O2|Outcome|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
632079|NCT01075347|O1|Outcome|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
632080|NCT01075347|E2|Reported Event|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
632081|NCT01075347|E1|Reported Event|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
632082|NCT01075399|B1|Baseline|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
632083|NCT01075399|P1|Participant Flow|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
632084|NCT01075399|O1|Outcome|Subjects That Received 1st and 2nd [F18] HX4 Scans|Single arm study. This group includes all subjects that successfully received [F18]HX4 PET scan on 2 separate occasions within 6 days apart to assess reproducibility in measuring tumor hypoxia.
632085|NCT01075399|E1|Reported Event|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
632086|NCT01075646|B5|Baseline|Total|Total of all reporting groups
632087|NCT01075646|B4|Baseline|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
632088|NCT01075646|B3|Baseline|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
632089|NCT01075646|B2|Baseline|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
632090|NCT01075646|B1|Baseline|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
632091|NCT01075646|P4|Participant Flow|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
632092|NCT01075646|P3|Participant Flow|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
632093|NCT01075646|P2|Participant Flow|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
632094|NCT01075646|P1|Participant Flow|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
632095|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
632096|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
632097|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
632098|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
632099|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
632100|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
632101|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
632102|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
632103|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
632104|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
632105|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
632139|NCT01075763|B2|Baseline|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
637754|NCT01091116|O3|Outcome|High Dose|two doses
632106|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
632107|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
632108|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
632109|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
632110|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
632111|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
632112|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
632113|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
632114|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
632115|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
632116|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
632117|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
632153|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
632543|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
632118|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
632119|NCT01075646|E4|Reported Event|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
632120|NCT01075646|E3|Reported Event|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
632121|NCT01075646|E2|Reported Event|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
632122|NCT01075646|E1|Reported Event|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
632123|NCT01075685|B3|Baseline|Total|Total of all reporting groups
632124|NCT01075685|B2|Baseline|Minimum Information|
632125|NCT01075685|B1|Baseline|Web-based Alcohol Programme|
632140|NCT01075763|B1|Baseline|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632141|NCT01075763|P2|Participant Flow|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
632142|NCT01075763|P1|Participant Flow|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632143|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
632144|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632145|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
632146|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632147|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
632148|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632149|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
632150|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632151|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
632152|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632544|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
632154|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632155|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
632156|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632157|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
632158|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632159|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
632160|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632161|NCT01075763|E2|Reported Event|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
632162|NCT01075763|E1|Reported Event|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
632163|NCT01075815|B3|Baseline|Total|Total of all reporting groups
632164|NCT01075815|B2|Baseline|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632165|NCT01075815|B1|Baseline|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632329|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
632166|NCT01075815|P2|Participant Flow|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632167|NCT01075815|P1|Participant Flow|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632168|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632169|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632170|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632171|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632172|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632173|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632174|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632175|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632176|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632177|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632178|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632179|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632180|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632181|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632182|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632183|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632184|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632185|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632186|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632187|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632188|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632189|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632190|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632191|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632192|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632193|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632194|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632195|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632196|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632197|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632198|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632199|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632200|NCT01075815|E2|Reported Event|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
632201|NCT01075815|E1|Reported Event|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
632202|NCT01075958|B1|Baseline|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
632203|NCT01075958|P1|Participant Flow|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
632204|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
632205|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
632206|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
632207|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
632208|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
632209|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
632210|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
632211|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
632212|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
632213|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
632214|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
632215|NCT01075958|E1|Reported Event|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
632216|NCT01075971|B1|Baseline|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
632217|NCT01075971|P1|Participant Flow|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
632218|NCT01075971|O1|Outcome|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
632219|NCT01075971|E1|Reported Event|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
632220|NCT01075984|B6|Baseline|Total|Total of all reporting groups
632248|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632221|NCT01075984|B5|Baseline|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632222|NCT01075984|B4|Baseline|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632223|NCT01075984|B3|Baseline|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632224|NCT01075984|B2|Baseline|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632225|NCT01075984|B1|Baseline|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632226|NCT01075984|P5|Participant Flow|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632227|NCT01075984|P4|Participant Flow|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632228|NCT01075984|P3|Participant Flow|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632229|NCT01075984|P2|Participant Flow|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632230|NCT01075984|P1|Participant Flow|Posaconazole (POS) 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632231|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632232|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632233|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632234|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632235|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632263|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632236|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632237|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632238|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632239|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632240|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632241|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632242|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632243|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632244|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632245|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632246|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632247|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632330|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
632249|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632250|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632251|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632252|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632253|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632254|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632255|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632256|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632257|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632258|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632259|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632260|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632261|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632262|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632299|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
632264|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632265|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632266|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632267|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632268|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632269|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632270|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632271|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632272|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632273|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632274|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632275|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632276|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632277|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632278|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632279|NCT01075984|E4|Reported Event|POS 300 mg IV BID (Cohort 2 and 3)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2); POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
632280|NCT01075984|E3|Reported Event|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
632281|NCT01075984|E2|Reported Event|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632282|NCT01075984|E1|Reported Event|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
632283|NCT01076036|B1|Baseline|Investigational|CorPath® 200 System
632284|NCT01076036|P1|Participant Flow|Group 1|Group 1 was treated using the CorPath device.
632285|NCT01076036|O1|Outcome|Investigational|CorPath® 200 System
632286|NCT01076036|O1|Outcome|Investigational|CorPath® 200 System
632287|NCT01076036|E1|Reported Event|Investigational|CorPath® 200 System
632288|NCT01076075|B3|Baseline|Total|Total of all reporting groups
632289|NCT01076075|B2|Baseline|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
632290|NCT01076075|B1|Baseline|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
632291|NCT01076075|P2|Participant Flow|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
632292|NCT01076075|P1|Participant Flow|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
632293|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Weeks 0-24: Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
632294|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
632295|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Weeks 0-24: Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
632296|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
632297|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
632298|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Week 0-24): Sitagliptin 100 mg
632303|NCT01076075|E2|Reported Event|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
632304|NCT01076075|E1|Reported Event|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
632305|NCT01076088|B7|Baseline|Total|Total of all reporting groups
632306|NCT01076088|B6|Baseline|Placebo|Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
632307|NCT01076088|B5|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
632308|NCT01076088|B4|Baseline|Metformin 850|Metformin 850 mg twice daily
632309|NCT01076088|B3|Baseline|Metformin 500 mg|Metformin 500 mg twice daily
632310|NCT01076088|B2|Baseline|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
632311|NCT01076088|B1|Baseline|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
632312|NCT01076088|P6|Participant Flow|Placebo|Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
632313|NCT01076088|P5|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
632314|NCT01076088|P4|Participant Flow|Metformin 850|Metformin 850 mg twice daily
632315|NCT01076088|P3|Participant Flow|Metformin 500 mg|Metformin 500 mg twice daily
632316|NCT01076088|P2|Participant Flow|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
632317|NCT01076088|P1|Participant Flow|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
632318|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
632319|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
632320|NCT01076088|O4|Outcome|Metformin 850|Metformin 850 mg twice daily
632321|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
632322|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
632323|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
632324|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
632325|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
632326|NCT01076088|O4|Outcome|Metformin 850|Metformin 850 mg twice daily
632327|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
632328|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
632334|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
632335|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
632336|NCT01076088|E6|Reported Event|Placebo|Matching placebo to sitagliptin and/or metformin. Population excludes 1 participant who did not receive any study medication.
632337|NCT01076088|E5|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
632338|NCT01076088|E4|Reported Event|Metformin 850|Metformin 850 mg twice daily
632339|NCT01076088|E3|Reported Event|Metformin 500 mg|Metformin 500 mg twice daily
632340|NCT01076088|E2|Reported Event|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
632341|NCT01076088|E1|Reported Event|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
632342|NCT01076153|B1|Baseline|Klacid MR|The per-protocol population (694 participants) of male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR.
632343|NCT01076153|P1|Participant Flow|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
632344|NCT01076153|O1|Outcome|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
632345|NCT01076153|O4|Outcome|Klacid MR (URTI and LRTI, Recovered)|Participants in the recovered population who had a diagnosis of both upper and lower respiratory tract infections at study entry.
632346|NCT01076153|O3|Outcome|Klacid MR (LRTI, Recovered)|Participants in the recovered population who had a diagnosis of lower respiratory tract infection (LRTI) at study entry.
632347|NCT01076153|O2|Outcome|Klacid MR (URTI, Recovered)|Participants in the recovered population who had a diagnosis of upper respiratory tract infection (URTI) at study entry.
632348|NCT01076153|O1|Outcome|Klacid MR (Total Number Recovered)|Male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR who were in the recovered population.
632349|NCT01076153|E1|Reported Event|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
632350|NCT01076166|B1|Baseline|Klacid Granules (Total)|The per-protocol population (308 participants) of male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
632351|NCT01076166|P1|Participant Flow|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
632352|NCT01076166|O1|Outcome|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
632353|NCT01076166|O3|Outcome|Klacid Granules (Pneumonia, Recovered)|Participants in the recovered population who had a diagnosis of pneumonia at study entry.
632354|NCT01076166|O2|Outcome|Klacid Granules (Bronchitis, Recovered)|Participants in the recovered population who had a diagnosis of bronchitis at study entry.
632355|NCT01076166|O1|Outcome|Klacid Granules (Total Number Recovered)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information who were in the recovered population.
632356|NCT01076166|E1|Reported Event|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
632357|NCT01076179|B1|Baseline|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632358|NCT01076179|P1|Participant Flow|HIV-infected Participants|Human immunodeficiency virus (HIV)-infected participants on Kaletra and integrase inhibitors (INIs) or non nucleoside reverse transcriptase inhibitors NNRTIs) or C-C chemokine receptor type 5 (CCR5) antagonists
632359|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
632360|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
632361|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632362|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632363|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632364|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632365|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632366|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632367|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632368|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632369|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632370|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632371|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632372|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632373|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632374|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632375|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632376|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632377|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632378|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
632379|NCT01076179|E1|Reported Event|HIV-infected Participants|HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
632380|NCT01076192|B1|Baseline|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632381|NCT01076192|P1|Participant Flow|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632382|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with adalimumab in routine clinical practice
632383|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632384|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632385|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632386|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632387|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632388|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632389|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632390|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632391|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632392|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632393|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632394|NCT01076192|E1|Reported Event|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
632395|NCT01076244|B1|Baseline|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
632396|NCT01076244|P1|Participant Flow|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
632397|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
632398|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
632399|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
632400|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
632401|NCT01076244|E1|Reported Event|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
632402|NCT01076270|B1|Baseline|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
plerixafor: Given SC
filgrastim: Given SC
peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells
allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
632403|NCT01076270|P1|Participant Flow|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
plerixafor: Given SC
filgrastim: Given SC
peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells
allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
632404|NCT01076270|O1|Outcome|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
plerixafor: Given SC
filgrastim: Given SC
peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells
allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
632405|NCT01076270|O1|Outcome|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
plerixafor: Given SC
filgrastim: Given SC
peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells
allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
632406|NCT01076270|E1|Reported Event|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
plerixafor: Given SC
filgrastim: Given SC
peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells
allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
632407|NCT01076283|B3|Baseline|Total|Total of all reporting groups
632408|NCT01076283|B2|Baseline|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
632409|NCT01076283|B1|Baseline|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
632410|NCT01076283|P2|Participant Flow|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
632411|NCT01076283|P1|Participant Flow|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
632412|NCT01076283|O2|Outcome|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
632413|NCT01076283|O1|Outcome|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
632414|NCT01076283|O2|Outcome|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
632415|NCT01076283|O1|Outcome|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
632416|NCT01076283|E2|Reported Event|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
632417|NCT01076283|E1|Reported Event|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
632418|NCT01076296|B1|Baseline|Total for All Groups Assessed|Subjects assessed for LV function using both VScan and a clinical examination.
632419|NCT01076296|P8|Participant Flow|No Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
632420|NCT01076296|P7|Participant Flow|Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.
632421|NCT01076296|P6|Participant Flow|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.
632422|NCT01076296|P5|Participant Flow|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.
632423|NCT01076296|P4|Participant Flow|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
632424|NCT01076296|P3|Participant Flow|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
632425|NCT01076296|P2|Participant Flow|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
632426|NCT01076296|P1|Participant Flow|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
632427|NCT01076296|O8|Outcome|No Heart Valve Disease|Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting no presence of HVD.
632428|NCT01076296|O7|Outcome|Heart Valve Disease|Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting the presence of HVD.
632429|NCT01076296|O6|Outcome|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the no presence of pulmonary hypertension.
632430|NCT01076296|O5|Outcome|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the presence of pulmonary hypertension.
632431|NCT01076296|O4|Outcome|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
632432|NCT01076296|O3|Outcome|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
632433|NCT01076296|O2|Outcome|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
632434|NCT01076296|O1|Outcome|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
632435|NCT01076296|E8|Reported Event|No Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
632436|NCT01076296|E7|Reported Event|Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.
632437|NCT01076296|E6|Reported Event|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.
632438|NCT01076296|E5|Reported Event|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.
632439|NCT01076296|E4|Reported Event|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
632440|NCT01076296|E3|Reported Event|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
632441|NCT01076296|E2|Reported Event|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
632442|NCT01076296|E1|Reported Event|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
632443|NCT01076335|B1|Baseline|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
632444|NCT01076335|P1|Participant Flow|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
632445|NCT01076335|O1|Outcome|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
632446|NCT01076335|E1|Reported Event|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
632447|NCT01076348|B1|Baseline|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
632448|NCT01076348|P1|Participant Flow|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
632449|NCT01076348|O1|Outcome|Medtronic 4965 Epicardial Lead|Subjects who were implanted with at least 1 model 4965 lead.
632450|NCT01076348|E1|Reported Event|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
632451|NCT01076361|B1|Baseline|All Enrolled Patients|All patients who were enrolled and implanted with a Model 4968 Lead
632452|NCT01076361|P1|Participant Flow|Model 4968 Leads|A total of 631 leads were implanted in 370 patients. 22 leads in 21 patients were excluded from analysis.
632453|NCT01076361|O1|Outcome|Model 4968 Lead Survival Probability|Model 4968 is steroid-eluting bipolar epicardial pacing lead. Participants implanted with Model 4968 lead their data will be obtained for long-term safety and lead events, includes the survival probability for the Model 4968.
632454|NCT01076361|E1|Reported Event|Model 4968 Participants|All Model 4968 participants in the analysis cohort
632455|NCT01070693|B3|Baseline|Total|Total of all reporting groups
632456|NCT01070693|B2|Baseline|Lichtenstein|Inguinal hernia repair with the Lichtenstein technique
632457|NCT01070693|B1|Baseline|Prolene Hernia System Device|Inguinal hernia repair either with a bilayer mesh (PHS)
632458|NCT01070693|P2|Participant Flow|Lichtenstein|Inguinal hernia repair with the Lichtenstein technique
632545|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
632460|NCT01070693|O2|Outcome|Lichtenstein|"Inguinal hernia repair with the Lichtenstein technique
Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique
Lichtenstein technique: Lichtenstein technique"
632461|NCT01070693|O1|Outcome|Prolene Hernia System Device|"Inguinal hernia repair either with a bilayer mesh (PHS)
Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique
Prolene Hernia System: Prolene Hernia System"
632462|NCT01070693|E2|Reported Event|Lichtenstein|"Inguinal hernia repair with the Lichtenstein technique
Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique
Lichtenstein technique: Lichtenstein technique"
632463|NCT01070693|E1|Reported Event|Prolene Hernia System Device|"Inguinal hernia repair either with a bilayer mesh (PHS)
Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique
Prolene Hernia System: Prolene Hernia System"
632464|NCT01076452|B3|Baseline|Total|Total of all reporting groups
632465|NCT01076452|B2|Baseline|Arm 2|"GPi (Globus Pallidus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632466|NCT01076452|B1|Baseline|Arm 1|"STN (Subthalamic Nucleus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632467|NCT01076452|P2|Participant Flow|Arm 2|"GPi (Globus Pallidus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632468|NCT01076452|P1|Participant Flow|Arm 1|"STN (Subthalamic Nucleus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632469|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632470|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632471|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632472|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632473|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632474|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632508|NCT01076686|O3|Outcome|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
632475|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632476|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632477|NCT01076452|E2|Reported Event|Arm 2|"GPi (Globus Pallidus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632478|NCT01076452|E1|Reported Event|Arm 1|"STN (Subthalamic Nucleus)
Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
632479|NCT01076504|B1|Baseline|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
632480|NCT01076504|P1|Participant Flow|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
632481|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
632482|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
632483|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
632484|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
632485|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
632486|NCT01076504|E1|Reported Event|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
632487|NCT01076647|B3|Baseline|Total|Total of all reporting groups
632488|NCT01076647|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
632546|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
632547|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
632489|NCT01076647|B1|Baseline|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
632490|NCT01076647|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
632491|NCT01076647|P1|Participant Flow|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
632492|NCT01076647|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
632493|NCT01076647|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
632494|NCT01076647|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
632495|NCT01076647|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
632496|NCT01076647|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
632497|NCT01076647|E1|Reported Event|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
632498|NCT01076686|B5|Baseline|Total|Total of all reporting groups
632499|NCT01076686|B4|Baseline|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632500|NCT01076686|B3|Baseline|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
632501|NCT01076686|B2|Baseline|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632502|NCT01076686|B1|Baseline|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632503|NCT01076686|P4|Participant Flow|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632504|NCT01076686|P3|Participant Flow|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
632505|NCT01076686|P2|Participant Flow|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632506|NCT01076686|P1|Participant Flow|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632507|NCT01076686|O4|Outcome|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632509|NCT01076686|O2|Outcome|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632510|NCT01076686|O1|Outcome|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632511|NCT01076686|E4|Reported Event|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632512|NCT01076686|E3|Reported Event|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
632513|NCT01076686|E2|Reported Event|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632514|NCT01076686|E1|Reported Event|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
632515|NCT01085045|B1|Baseline|All Subjects|All Baseline Subjects
632516|NCT01085045|P1|Participant Flow|Overall Study|Sentinel patients were the first 4 patients enrolled to receive one week of treatment with either GFF MDI 72/9.6mcg, GFF MDI 36/9.6 mcg, GP MDI 36 mcg or FF MDI 9.6 mcg because this was the first time GFF MDI was administered to patients with COPD, the sentinel patients provided additional assurance of safety.9.6
632517|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
632518|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
632519|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
632520|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
632521|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
632522|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
632523|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
632524|NCT01085045|O6|Outcome|Foradil 12 μg|Foradil 12 μg
632525|NCT01085045|O5|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
632526|NCT01085045|O4|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
632527|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
632528|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
632529|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
632530|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
632531|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
632532|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
632533|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
632534|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
632535|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
632536|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
632537|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
632538|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
632539|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
632540|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
632541|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
632542|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
632571|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
632572|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
632573|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
632574|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
632575|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
632576|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
632577|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
632578|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
632579|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
632580|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
632581|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
632582|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
632583|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
632584|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
632585|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
632586|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
632587|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
632588|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
632589|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
632590|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
632591|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
632592|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
632593|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
632594|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
632595|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
632596|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
632597|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
632598|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
632599|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
632600|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
632601|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
632602|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
632603|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
632604|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
632605|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
632606|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
632607|NCT01085045|E8|Reported Event|Foradil Aerolizer|Foradil Aerolizer 12 μg
632608|NCT01085045|E7|Reported Event|Placebo|Placebo MDI
632609|NCT01085045|E6|Reported Event|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
632610|NCT01085045|E5|Reported Event|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
632611|NCT01085045|E4|Reported Event|Spiriva|Handihaler 18 μg
632615|NCT01085136|B1|Baseline|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
632616|NCT01085136|P3|Participant Flow|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632617|NCT01085136|P2|Participant Flow|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632618|NCT01085136|P1|Participant Flow|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
632619|NCT01085136|O3|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632620|NCT01085136|O2|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632621|NCT01085136|O1|Outcome|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
632622|NCT01085136|O2|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632623|NCT01085136|O1|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632827|NCT01085760|P4|Participant Flow|High Dose Metronidazole|metronidazole 500 mg 3 times a day
632624|NCT01085136|O1|Outcome|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
632625|NCT01085136|O2|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632626|NCT01085136|O1|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632627|NCT01085136|O1|Outcome|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
632628|NCT01085136|O2|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632629|NCT01085136|O1|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632630|NCT01085136|E3|Reported Event|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632631|NCT01085136|E2|Reported Event|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
632632|NCT01085136|E1|Reported Event|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
632633|NCT01085201|B6|Baseline|Total|Total of all reporting groups
632634|NCT01085201|B5|Baseline|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632635|NCT01085201|B4|Baseline|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632742|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
632636|NCT01085201|B3|Baseline|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632637|NCT01085201|B2|Baseline|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632638|NCT01085201|B1|Baseline|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632639|NCT01085201|P5|Participant Flow|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632640|NCT01085201|P4|Participant Flow|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632641|NCT01085201|P3|Participant Flow|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632642|NCT01085201|P2|Participant Flow|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632643|NCT01085201|P1|Participant Flow|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632644|NCT01085201|O5|Outcome|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632645|NCT01085201|O4|Outcome|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632646|NCT01085201|O3|Outcome|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632647|NCT01085201|O2|Outcome|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632648|NCT01085201|O1|Outcome|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632649|NCT01085201|O5|Outcome|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632650|NCT01085201|O4|Outcome|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632828|NCT01085760|P3|Participant Flow|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
632651|NCT01085201|O3|Outcome|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632652|NCT01085201|O2|Outcome|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632653|NCT01085201|O1|Outcome|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632654|NCT01085201|O5|Outcome|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632655|NCT01085201|O4|Outcome|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632656|NCT01085201|O3|Outcome|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632657|NCT01085201|O2|Outcome|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632658|NCT01085201|O1|Outcome|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632659|NCT01085201|E5|Reported Event|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632660|NCT01085201|E4|Reported Event|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632661|NCT01085201|E3|Reported Event|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632662|NCT01085201|E2|Reported Event|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632663|NCT01085201|E1|Reported Event|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.
Lexiscan : Given as an infusion"
632664|NCT01085214|B1|Baseline|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
632665|NCT01085214|P1|Participant Flow|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
632744|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
632666|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
632667|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
632668|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
632669|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
632670|NCT01085214|E1|Reported Event|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
632671|NCT01085318|B3|Baseline|Total|Total of all reporting groups
632672|NCT01085318|B2|Baseline|Arm 2 Healthy Control|Healthy Control
632673|NCT01085318|B1|Baseline|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
632674|NCT01085318|P2|Participant Flow|Arm 2 Healthy Control|Healthy Control
632675|NCT01085318|P1|Participant Flow|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
632676|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
632677|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
632678|NCT01085318|O2|Outcome|Arm 2 Healthy Control|Healthy Control
632679|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
632680|NCT01085318|O2|Outcome|Arm 2 Healthy Control|Healthy Control
632681|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
632682|NCT01085318|E2|Reported Event|Arm 2 Healthy Control|Healthy Control
632683|NCT01085318|E1|Reported Event|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
632684|NCT01085331|B3|Baseline|Total|Total of all reporting groups
632685|NCT01085331|B2|Baseline|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632686|NCT01085331|B1|Baseline|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632687|NCT01085331|P2|Participant Flow|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; Irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632688|NCT01085331|P1|Participant Flow|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 milligrams per day (mg/day) once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2.) at conventional doses on days 1 and 15 of the same 28 day cycle.
632689|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632690|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632691|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632692|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632743|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
632693|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632694|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632695|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632696|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632697|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632698|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632760|NCT01085539|P1|Participant Flow|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
632761|NCT01085539|O1|Outcome|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
632699|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632700|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632701|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632702|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632703|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632704|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632705|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632706|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632707|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632708|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632709|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632710|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632762|NCT01085539|E1|Reported Event|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
632763|NCT01085591|B4|Baseline|Total|Total of all reporting groups
632764|NCT01085591|B3|Baseline|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
632711|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632712|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632713|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632714|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632715|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632716|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632717|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632718|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632719|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo +FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a Bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632720|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632721|NCT01085331|O1|Outcome|Pimasertib+FOLFIRI (Overall)|Pimasertib was administered orally once daily 45 mg/day and 60 mg/day on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a Bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632722|NCT01085331|E2|Reported Event|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632765|NCT01085591|B2|Baseline|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
632766|NCT01085591|B1|Baseline|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632767|NCT01085591|P3|Participant Flow|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
632723|NCT01085331|E1|Reported Event|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
632724|NCT01085357|B3|Baseline|Total|Total of all reporting groups
632725|NCT01085357|B2|Baseline|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
632726|NCT01085357|B1|Baseline|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
632727|NCT01085357|P2|Participant Flow|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
632728|NCT01085357|P1|Participant Flow|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
632729|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
632730|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
632731|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
632732|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
632733|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
632734|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
632735|NCT01085357|E2|Reported Event|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
632736|NCT01085357|E1|Reported Event|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
632737|NCT01085500|B3|Baseline|Total|Total of all reporting groups
632738|NCT01085500|B2|Baseline|Current Practice|General surgery residents will undergo training according to current practice.
632739|NCT01085500|B1|Baseline|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
632740|NCT01085500|P2|Participant Flow|Current Practice|General surgery residents will undergo training according to current practice.
632741|NCT01085500|P1|Participant Flow|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
637755|NCT01091116|O2|Outcome|Mid Dose|two doses
632745|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
632746|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
632747|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
632748|NCT01085500|E2|Reported Event|Current Practice|General surgery residents will undergo training according to current practice.
632749|NCT01085500|E1|Reported Event|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
632750|NCT01085513|B3|Baseline|Total|Total of all reporting groups
632751|NCT01085513|B2|Baseline|Healthy Volunteers|"Healthy volunteers
PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
632752|NCT01085513|B1|Baseline|Patients|"Patients previously indicated for manometry
PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
632753|NCT01085513|P2|Participant Flow|Healthy Volunteers|Healthy volunteers
632754|NCT01085513|P1|Participant Flow|Patients|Patients previously indicated for manometry
632755|NCT01085513|O2|Outcome|Patients|"Patients previously indicated for manometry
PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
632756|NCT01085513|O1|Outcome|Healthy Volunteers|"Healthy volunteers
PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
632757|NCT01085513|E2|Reported Event|Healthy Volunteers|"Healthy volunteers
PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
632758|NCT01085513|E1|Reported Event|Patients|"Patients previously indicated for manometry
Two Moderate adverse events not related to studies procedure were reported within this study: abdominal pain and nausea.
In one case (i.e., abdominal pain) emergency visit occurred and the adverse events was resolved within four days."
632759|NCT01085539|B1|Baseline|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
632768|NCT01085591|P2|Participant Flow|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
632769|NCT01085591|P1|Participant Flow|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632770|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
632771|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632772|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632773|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
632774|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632775|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632776|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
632777|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632778|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632779|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
632780|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632781|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632782|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
632783|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632784|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632785|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
632786|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632787|NCT01085591|O1|Outcome|CB-183,315, 125mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632788|NCT01085591|E3|Reported Event|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
633120|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
632789|NCT01085591|E2|Reported Event|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
632790|NCT01085591|E1|Reported Event|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
632791|NCT01085643|B1|Baseline|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
632792|NCT01085643|P1|Participant Flow|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
632793|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
632794|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
632795|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
632796|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
632797|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
632798|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
632799|NCT01085643|E1|Reported Event|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
632800|NCT01085682|B3|Baseline|Total|Total of all reporting groups
632801|NCT01085682|B2|Baseline|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
632802|NCT01085682|B1|Baseline|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
632803|NCT01085682|P2|Participant Flow|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
632804|NCT01085682|P1|Participant Flow|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
632805|NCT01085682|O2|Outcome|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
632806|NCT01085682|O1|Outcome|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
632807|NCT01085682|E2|Reported Event|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
632808|NCT01085682|E1|Reported Event|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
632809|NCT01085734|B3|Baseline|Total|Total of all reporting groups
632810|NCT01085734|B2|Baseline|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
632811|NCT01085734|B1|Baseline|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
632812|NCT01085734|P2|Participant Flow|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
632856|NCT01085786|O2|Outcome|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
633121|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
632813|NCT01085734|P1|Participant Flow|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 micros
632814|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
632815|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns
632816|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
632817|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns
632818|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
632819|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
632820|NCT01085734|E2|Reported Event|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
632821|NCT01085734|E1|Reported Event|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
632822|NCT01085760|B5|Baseline|Total|Total of all reporting groups
632823|NCT01085760|B4|Baseline|High Dose Metronidazole|metronidazole 500 mg 3 times a day
632824|NCT01085760|B3|Baseline|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
632825|NCT01085760|B2|Baseline|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
632826|NCT01085760|B1|Baseline|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
632829|NCT01085760|P2|Participant Flow|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
632830|NCT01085760|P1|Participant Flow|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
632831|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
632832|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
632833|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
632834|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
632835|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
632836|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
632837|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
632838|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
632839|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
632840|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
632841|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
632842|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
632843|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
632844|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
632845|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
632846|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
632847|NCT01085760|E4|Reported Event|High Dose Metronidazole|metronidazole 500 mg 3 times a day
632848|NCT01085760|E3|Reported Event|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
632849|NCT01085760|E2|Reported Event|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
632850|NCT01085760|E1|Reported Event|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
632851|NCT01085786|B3|Baseline|Total|Total of all reporting groups
632852|NCT01085786|B2|Baseline|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
632853|NCT01085786|B1|Baseline|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
632854|NCT01085786|P2|Participant Flow|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
632855|NCT01085786|P1|Participant Flow|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
633122|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
632857|NCT01085786|O1|Outcome|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
632858|NCT01085786|E2|Reported Event|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
632859|NCT01085786|E1|Reported Event|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
632860|NCT01085825|B3|Baseline|Total|Total of all reporting groups
632861|NCT01085825|B2|Baseline|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
632862|NCT01085825|B1|Baseline|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
632863|NCT01085825|P2|Participant Flow|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
632864|NCT01085825|P1|Participant Flow|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
632865|NCT01085825|O2|Outcome|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
632866|NCT01085825|O1|Outcome|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
632867|NCT01085825|E2|Reported Event|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
632868|NCT01085825|E1|Reported Event|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
632869|NCT01085903|B3|Baseline|Total|Total of all reporting groups
632870|NCT01085903|B2|Baseline|Stroke Subjects|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline, CPS, and Post CPS and then are randomized to modafinil or placebo.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.
Post CPS: 20 minutes following the CPS condition. Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
632871|NCT01085903|B1|Baseline|Normal Subjects|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.
Post CPS: 20 minutes following the CPS condition."
633372|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
632872|NCT01085903|P3|Participant Flow|Stroke Subjects: Modafinil Then Placebo|"Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.
Post CPS: 20 minutes following the CPS condition."
632873|NCT01085903|P2|Participant Flow|Stroke Subjects: Placebo Then Modafinil|"Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.
Post CPS: 20 minutes following the CPS condition."
632874|NCT01085903|P1|Participant Flow|Normal Subjects Baseline|"Normal subjects are persons without stroke who receive baseline, Cold Pressor Stimulation (CPS), Post CPS and Follow up interventions.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.
Post CPS: 20 minutes following the CPS condition."
632875|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patientseal for three days administered only to stroke patients"
632876|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.
Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
632877|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
632878|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
632923|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
632879|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline and CPS conditions.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
632880|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
632881|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.
Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
632882|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
632883|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
632884|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
632885|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
632886|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.
Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
632887|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
633193|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
632888|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
632889|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
632890|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
632891|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients
632892|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
632893|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
632894|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
632895|NCT01085903|E2|Reported Event|Stroke Subjects|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.
Post CPS: 20 minutes following the CPS condition.
Follow up: Follow up testing occurred at 3 months"
632924|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
633123|NCT01086475|E2|Reported Event|Placebo|Subjects who received placebo
632896|NCT01085903|E1|Reported Event|Normal Subjects|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.
Baseline: Observations made at baseline before any intervention
CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.
Post CPS: 20 minutes following the CPS condition.
Follow up: Follow up testing occurred at 3 months"
632897|NCT01085968|B3|Baseline|Total|Total of all reporting groups
632898|NCT01085968|B2|Baseline|Control Subjects|"Age matched controls
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632899|NCT01085968|B1|Baseline|PD Subjects|"PD subjects
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632900|NCT01085968|P2|Participant Flow|Control Subjects|"Age matched controls
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632901|NCT01085968|P1|Participant Flow|PD Subjects|"PD subjects
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632902|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632903|NCT01085968|O1|Outcome|PD Subjects|"PD subjects
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632904|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632905|NCT01085968|O1|Outcome|PD Subjects|"PD subjects
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632906|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632907|NCT01085968|O1|Outcome|PD Subjects|"PD subjects
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632908|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632909|NCT01085968|O1|Outcome|PD Subjects|"PD subjects
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
633138|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
632910|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632911|NCT01085968|O1|Outcome|PD Subjects|"PD subjects
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632912|NCT01085968|E2|Reported Event|Control Subjects|"Age matched controls
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632913|NCT01085968|E1|Reported Event|PD Subjects|"PD subjects
PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
632914|NCT01086033|B1|Baseline|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
632915|NCT01086033|P1|Participant Flow|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
632916|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
632917|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
632918|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
632919|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
632920|NCT01086033|O3|Outcome|No Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
632921|NCT01086033|O2|Outcome|Moderate Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
632922|NCT01086033|O1|Outcome|Good Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Good Response per EULAR criteria.
633115|NCT01086475|P2|Participant Flow|Placebo|Subjects who received placebo
632925|NCT01086033|E1|Reported Event|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
632926|NCT01086215|B5|Baseline|Total|Total of all reporting groups
632927|NCT01086215|B4|Baseline|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
632928|NCT01086215|B3|Baseline|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
632929|NCT01086215|B2|Baseline|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
632930|NCT01086215|B1|Baseline|Limb Ischemia|Patients presenting with limb ischemia for treatment
632931|NCT01086215|P4|Participant Flow|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
632932|NCT01086215|P3|Participant Flow|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
632933|NCT01086215|P2|Participant Flow|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
632934|NCT01086215|P1|Participant Flow|Limb Ischemia|Patients presenting with limb ischemia for treatment
632935|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
632936|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
632937|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
632938|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
632939|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
632940|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
632941|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
632942|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
632943|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
632944|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
632945|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
632946|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
632947|NCT01086215|E4|Reported Event|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
632948|NCT01086215|E3|Reported Event|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
632949|NCT01086215|E2|Reported Event|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
632950|NCT01086215|E1|Reported Event|Limb Ischemia|Patients presenting with limb ischemia for treatment
632951|NCT01086384|B3|Baseline|Total|Total of all reporting groups
633366|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
632952|NCT01086384|B2|Baseline|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632953|NCT01086384|B1|Baseline|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632954|NCT01086384|P3|Participant Flow|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632955|NCT01086384|P2|Participant Flow|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632956|NCT01086384|P1|Participant Flow|FP 250 µg/ICS|Japanese participants using fluticasone propionate (FP)/salmeterol 250/50 micrograms (µg) twice daily received open-label FP 250 µg to ensure they continued their inhaled corticosteroid (ICS) therapy at a fixed dose during the 2-week Run-in Period. All other participants continued to use their current ICS therapy at a fixed dose during the 2-week Run-in Period. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Run-in Period.
632957|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632958|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632959|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632960|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632961|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632962|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632963|NCT01086384|E2|Reported Event|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632964|NCT01086384|E1|Reported Event|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
632965|NCT01086410|B5|Baseline|Total|Total of all reporting groups
632966|NCT01086410|B4|Baseline|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
632967|NCT01086410|B3|Baseline|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632968|NCT01086410|B2|Baseline|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632969|NCT01086410|B1|Baseline|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
632970|NCT01086410|P4|Participant Flow|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
632971|NCT01086410|P3|Participant Flow|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633192|NCT01086852|P1|Participant Flow|Active Treatment With FACTOR X|Four subjects underwent 4 major surgeries with active treatment (FACTOR X)
632972|NCT01086410|P2|Participant Flow|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632973|NCT01086410|P1|Participant Flow|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
632974|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
632975|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632976|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632977|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
632978|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
632979|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632980|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632981|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
632982|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
632983|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632984|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632985|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
632986|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
632987|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632988|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632989|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
632990|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
632991|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632992|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632993|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
632994|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
632995|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632996|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
632997|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
637756|NCT01091116|O1|Outcome|Low Dose|two doses
632998|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
632999|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633000|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633001|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633002|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633003|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633004|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633005|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633006|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633007|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
644906|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
633008|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633009|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633010|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633011|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633012|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633013|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633014|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633015|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633016|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633017|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633018|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633019|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633020|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633021|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633022|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633023|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633024|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633025|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
644907|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
633026|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633027|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633028|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633029|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633030|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633031|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633032|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633033|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633034|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633035|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633036|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633037|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633038|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633039|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633040|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633041|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633042|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633043|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
644908|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
633044|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633045|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633046|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633047|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633048|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633049|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633050|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633051|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633052|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633053|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633054|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633055|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633056|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633057|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633058|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633059|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633060|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633061|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
644909|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
633062|NCT01086410|E4|Reported Event|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
633063|NCT01086410|E3|Reported Event|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633064|NCT01086410|E2|Reported Event|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
633065|NCT01086410|E1|Reported Event|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
633066|NCT01086423|B4|Baseline|Total|Total of all reporting groups
633067|NCT01086423|B3|Baseline|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633068|NCT01086423|B2|Baseline|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633069|NCT01086423|B1|Baseline|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633070|NCT01086423|P3|Participant Flow|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633116|NCT01086475|P1|Participant Flow|D-cycloserine|Subjects who received d-cycloserine
633071|NCT01086423|P2|Participant Flow|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633072|NCT01086423|P1|Participant Flow|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633073|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633074|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633075|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633076|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633077|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633078|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633079|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633080|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633081|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633082|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633137|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633083|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633084|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633085|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633086|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633087|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633088|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633089|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633090|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633091|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633117|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
633092|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633093|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633094|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633095|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633096|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633097|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633098|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633099|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633100|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633101|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633102|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633103|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633104|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
644910|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
633105|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633106|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633107|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633108|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633109|NCT01086423|E3|Reported Event|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
633110|NCT01086423|E2|Reported Event|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
633111|NCT01086423|E1|Reported Event|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
633112|NCT01086475|B3|Baseline|Total|Total of all reporting groups
633113|NCT01086475|B2|Baseline|Placebo|"Subjects randomized to placebo arm will receive placebo pill 30 minutes prior to each of ten Social Skills Training Sessions
Placebo: Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions"
633114|NCT01086475|B1|Baseline|D-cycloserine|"Subjects randomized to D-cycloserine will be administered 50 mg 30 minutes prior to each of ten Social Skills Training Sessions
D-cycloserine: 50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions"
633124|NCT01086475|E1|Reported Event|D-cycloserine|Subjects who received d-cycloserine
633125|NCT01086605|B3|Baseline|Total|Total of all reporting groups
633126|NCT01086605|B2|Baseline|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633127|NCT01086605|B1|Baseline|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633128|NCT01086605|P2|Participant Flow|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633129|NCT01086605|P1|Participant Flow|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633130|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633131|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633132|NCT01086605|O1|Outcome|Arm I/Group A + Arm II/Group B|"Arm I/Group A: Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Arm II/Group B: Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
633133|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633134|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633135|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633136|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633512|NCT01087814|O1|Outcome|Efavirenz (Tablet)|All subjects took efavirenz.
633139|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633140|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633141|NCT01086605|E2|Reported Event|Arm II/Group B|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633142|NCT01086605|E1|Reported Event|Arm I/Group A|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
633143|NCT01086761|B6|Baseline|Total|Total of all reporting groups
633144|NCT01086761|B5|Baseline|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
633145|NCT01086761|B4|Baseline|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
633146|NCT01086761|B3|Baseline|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
633147|NCT01086761|B2|Baseline|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
633148|NCT01086761|B1|Baseline|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
633149|NCT01086761|P6|Participant Flow|MP0112 (3.6 mg)|Single 3.6 mg intravitreal injection of MP0112 in the study eye.
633150|NCT01086761|P5|Participant Flow|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
633151|NCT01086761|P4|Participant Flow|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
633152|NCT01086761|P3|Participant Flow|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
633153|NCT01086761|P2|Participant Flow|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
633154|NCT01086761|P1|Participant Flow|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
633155|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
633156|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
633157|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
633158|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
633159|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
633160|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
633161|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
633162|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
633163|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
633164|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
633165|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
633166|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
633167|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
633168|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
633169|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
633170|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
633171|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
633172|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
633173|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
633174|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
633175|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
633176|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
633177|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
633178|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
633179|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
633180|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
633181|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
633182|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
633183|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
633184|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
633185|NCT01086761|O1|Outcome|MP0112|Single intravitreal injection of MP0112 in the study eye of one of the following doses: 0.04 mg, 0.15 mg, 0.4 mg, 1.0 mg or 2.0 mg.
633186|NCT01086761|E5|Reported Event|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
633187|NCT01086761|E4|Reported Event|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
633188|NCT01086761|E3|Reported Event|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
633189|NCT01086761|E2|Reported Event|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
633190|NCT01086761|E1|Reported Event|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
633191|NCT01086852|B1|Baseline|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
633194|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
633195|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
633196|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
633197|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
633198|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
633199|NCT01086852|O1|Outcome|FACTOR X|"Human Coagulation Factor X
FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.
Post surgery- FX trough levels of 50% should be achieved.
Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
633200|NCT01086852|O1|Outcome|FACTOR X|"Human Coagulation Factor X
FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.
Post surgery- FX trough levels of 50% should be achieved.
Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
633201|NCT01086852|E1|Reported Event|FACTOR X|"Human Coagulation Factor X
FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.
Post surgery- FX trough levels of 50% should be achieved.
Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
633202|NCT01086969|B4|Baseline|Total|Total of all reporting groups
633203|NCT01086969|B3|Baseline|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
633204|NCT01086969|B2|Baseline|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
633205|NCT01086969|B1|Baseline|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
633206|NCT01086969|P3|Participant Flow|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
633207|NCT01086969|P2|Participant Flow|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
633208|NCT01086969|P1|Participant Flow|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
633209|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
633210|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
633211|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
633212|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
633213|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
633214|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
633215|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
633216|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
633217|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
633218|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
633219|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
633220|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
633221|NCT01086969|E3|Reported Event|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
633222|NCT01086969|E2|Reported Event|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
633223|NCT01086969|E1|Reported Event|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
633224|NCT01087489|B1|Baseline|All Study Participants|Each participant was randomly assigned to receive either anesthetic preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day.
633225|NCT01087489|P2|Participant Flow|Unilateral|Each participant was randomly assigned to receive an intravitreal injection with 4% lidocaine prep on one visit and 3.5% lidocaine gel on the next visit.
633226|NCT01087489|P1|Participant Flow|Bilateral|Participants were given bilateral injections with 4% lidocaine prep in one eye and 3.5% lidocaine gel in the other.
633227|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
633228|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
633229|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
633230|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
633231|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
633232|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
633233|NCT01087489|E2|Reported Event|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
633234|NCT01087489|E1|Reported Event|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
633235|NCT01087502|B3|Baseline|Total|Total of all reporting groups
633236|NCT01087502|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
633237|NCT01087502|B1|Baseline|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
633238|NCT01087502|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
633239|NCT01087502|P1|Participant Flow|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
633240|NCT01087502|O1|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
633241|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
633242|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
633243|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
633244|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
633245|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
633246|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
633247|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
633248|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
633249|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
633250|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
633251|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
633252|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
633253|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
633254|NCT01087502|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
633255|NCT01087502|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
633256|NCT01087502|E1|Reported Event|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
633257|NCT01073566|B3|Baseline|Total|Total of all reporting groups
633258|NCT01073566|B2|Baseline|Usual Injection Device Then Finesse|Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
633259|NCT01073566|B1|Baseline|Finesse Then Usual Injection Device|Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
633260|NCT01073566|P2|Participant Flow|Usual Injection Device Then Finesse|Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
633261|NCT01073566|P1|Participant Flow|Finesse Then Usual Injection Device|Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
633262|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
633263|NCT01073566|O1|Outcome|Finesse|Bolus Patch
633264|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
633265|NCT01073566|O1|Outcome|Finesse|Bolus Patch
633266|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
633267|NCT01073566|O1|Outcome|Finesse|Bolus Patch
633268|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
633269|NCT01073566|O1|Outcome|Finesse|Bolus Patch
633270|NCT01073566|E2|Reported Event|Usual Injection Device|Pen/Syringe
633271|NCT01073566|E1|Reported Event|Finesse|Bolus Patch
633272|NCT01073605|B4|Baseline|Total|Total of all reporting groups
633273|NCT01073605|B3|Baseline|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633274|NCT01073605|B2|Baseline|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633367|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
633368|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
633275|NCT01073605|B1|Baseline|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633276|NCT01073605|P3|Participant Flow|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633277|NCT01073605|P2|Participant Flow|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633278|NCT01073605|P1|Participant Flow|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram [mg]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633279|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633280|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633281|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633282|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633283|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633284|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633285|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633286|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633287|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633343|NCT01073865|P2|Participant Flow|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
637757|NCT01091116|E5|Reported Event|Placebo|two doses
633288|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633289|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633290|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633291|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633292|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633293|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633294|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633295|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633296|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633297|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633298|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633299|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633300|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633301|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633302|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633303|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633304|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633305|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633306|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633307|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633308|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633309|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633310|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633311|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633312|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633313|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633314|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633315|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633316|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633317|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633318|NCT01073605|E3|Reported Event|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633319|NCT01073605|E2|Reported Event|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633320|NCT01073605|E1|Reported Event|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram [mg]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
633321|NCT01073618|B1|Baseline|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
633322|NCT01073618|P1|Participant Flow|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
633323|NCT01073618|O1|Outcome|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
633324|NCT01073618|O1|Outcome|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
633325|NCT01073618|E1|Reported Event|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
633326|NCT01073631|B1|Baseline|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
633369|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
633370|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
633371|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
633327|NCT01073631|P1|Participant Flow|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
633328|NCT01073631|O1|Outcome|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
633329|NCT01073631|O1|Outcome|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
633330|NCT01073631|E1|Reported Event|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
633331|NCT01073657|B3|Baseline|Total|Total of all reporting groups
633332|NCT01073657|B2|Baseline|Active Control|Veterans recived peer services that did not address educational goals
633333|NCT01073657|B1|Baseline|Arm 1|Supported Education: Rehabilitation counseling using peers to achieve educational goals
633334|NCT01073657|P2|Participant Flow|General Peer Support|Veterans received peer services that did not address educational goals
633335|NCT01073657|P1|Participant Flow|Supported Education|Supported Education: Rehabilitation counseling using peers to achieve educational goals
633336|NCT01073657|O2|Outcome|General Peer Support|Matched peer attention no supported education service
633337|NCT01073657|O1|Outcome|Supported Education|Supported Education: Rehabilitation counseling using peers to achieve educational goals Intervention group
633338|NCT01073657|E2|Reported Event|Active Control|Veterans received matched peer attention that did not address educational goals
633339|NCT01073657|E1|Reported Event|Arm 1|Supported Education: Rehabilitation counseling using peers to achieve educational goals
633340|NCT01073865|B3|Baseline|Total|Total of all reporting groups
633341|NCT01073865|B2|Baseline|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
633342|NCT01073865|B1|Baseline|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
633681|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
633344|NCT01073865|P1|Participant Flow|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
633345|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
633346|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
633347|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
633348|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
633349|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
633350|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
633351|NCT01073865|E2|Reported Event|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
633352|NCT01073865|E1|Reported Event|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
633353|NCT01087528|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
633354|NCT01087528|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
633355|NCT01087528|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
633356|NCT01087528|E1|Reported Event|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
633357|NCT01087541|B3|Baseline|Total|Total of all reporting groups
633358|NCT01087541|B2|Baseline|Control Group|Usual healthcare of diabetics patients
633359|NCT01087541|B1|Baseline|Intervention|Behavioural program of education for health professionals of the study
633360|NCT01087541|P2|Participant Flow|Control Group|Usual healthcare of diabetics patients
633361|NCT01087541|P1|Participant Flow|Intervention|Behavioural program of education for health professionals of the study
633362|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
633363|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
633364|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
633365|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
633373|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
633374|NCT01087541|E2|Reported Event|Control Group|Usual healthcare
633375|NCT01087541|E1|Reported Event|Intervention Group|Intervention group: educational program
633376|NCT01087723|B3|Baseline|Total|Total of all reporting groups
633377|NCT01087723|B2|Baseline|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
633378|NCT01087723|B1|Baseline|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633379|NCT01087723|P2|Participant Flow|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of ST segment elevation acute coronary syndrome (STE-ACS ), not including bivalirudin: unfractionated heparin (UFH) (100 international units/kg [IU/kg] without glycoprotein IIb/IIIa inhibitor [GPI] and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-micrograms/kilogram [μg/kg] IV boluses with a 10-minute [min] interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or low molecular weight heparin (LMWH) with or without GPI and is referred to as heparins with optional GPI.”"
633380|NCT01087723|P1|Participant Flow|Bivalirudin|Given immediately upon enrolment as an intravenous (IV) bolus of 0.75 milligrams/kilogram (mg/kg), followed immediately by an infusion of 1.75 mg/kg/hour (mg/kg/h). This infusion was to be run continuously until completion of percutaneous coronary intervention (PCI), at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633406|NCT01087736|O2|Outcome|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
633682|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
633381|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
633382|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633383|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
633384|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633385|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
633386|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633417|NCT01087762|P4|Participant Flow|All CZP 200 mg|"All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633513|NCT01087814|E2|Reported Event|Over-encapsulated Efavirenz|Both arms received both versions of the drug over the course of the study.
633387|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
633388|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633389|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
633390|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633405|NCT01087736|P1|Participant Flow|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
633594|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
633391|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
633392|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633393|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
633394|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633395|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
633396|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633397|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
633398|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633399|NCT01087723|E2|Reported Event|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).
For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
633400|NCT01087723|E1|Reported Event|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
633401|NCT01087736|B3|Baseline|Total|Total of all reporting groups
633402|NCT01087736|B2|Baseline|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
633403|NCT01087736|B1|Baseline|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
633404|NCT01087736|P2|Participant Flow|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
633407|NCT01087736|O1|Outcome|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
633408|NCT01087736|O2|Outcome|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
633409|NCT01087736|O1|Outcome|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
633410|NCT01087736|E2|Reported Event|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
633411|NCT01087736|E1|Reported Event|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
633412|NCT01087762|B4|Baseline|Total Title|
633413|NCT01087762|B3|Baseline|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633414|NCT01087762|B2|Baseline|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633415|NCT01087762|B1|Baseline|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633416|NCT01087762|P5|Participant Flow|All CZP 400 mg|"All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633514|NCT01087814|E1|Reported Event|Efavirenz|Both arms received both versions of the drug during the course of the study.
633418|NCT01087762|P3|Participant Flow|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633419|NCT01087762|P2|Participant Flow|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633420|NCT01087762|P1|Participant Flow|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633421|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633422|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633423|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633470|NCT01087788|P2|Participant Flow|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
633424|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633425|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633426|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633427|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633428|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633429|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633430|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633431|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633432|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633433|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633434|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633435|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633436|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633437|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633560|NCT01088984|P1|Participant Flow|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633438|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633439|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633440|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633441|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633442|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633443|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633444|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633445|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633446|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633462|NCT01087762|E3|Reported Event|All CZP 200 mg + 400 mg|This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg and arm All CZP 400 mg.
633447|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633448|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633449|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633450|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633451|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633595|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
633452|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633453|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633454|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633455|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633456|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633457|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633458|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633459|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633460|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633461|NCT01087762|E4|Reported Event|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection."
633463|NCT01087762|E2|Reported Event|All CZP 400 mg (Safety Analysis)|"All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
633464|NCT01087762|E1|Reported Event|All CZP 200 mg (Safety Analysis)|"All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
633465|NCT01087788|B4|Baseline|Total Title|
633466|NCT01087788|B3|Baseline|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
633467|NCT01087788|B2|Baseline|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
633468|NCT01087788|B1|Baseline|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.
After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
633469|NCT01087788|P3|Participant Flow|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
633596|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
633471|NCT01087788|P1|Participant Flow|Placebo|"Matching Placebo (PBO) to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.
After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
633472|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind."
633473|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
633474|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
633475|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.
After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
633476|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind."
633477|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
633478|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
633479|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.
After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
633480|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind."
633481|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
633511|NCT01087814|O2|Outcome|Over-encapsulated Efavirenz|All subjects took over-encapsulated efavirenz.
633482|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
633483|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.
After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
633484|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
633485|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
633486|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.
After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
633487|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind."
633561|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633488|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
633489|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
633490|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.
After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
633491|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
633492|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
633493|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.
After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
633494|NCT01087788|E3|Reported Event|All CZP 200 mg + 400 mg|This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg Q2W and arm All CZP 400 mg Q4W.
633495|NCT01087788|E2|Reported Event|All CZP 400 mg Q4W|"This arm includes all subjects who were randomized to CZP 400 mg Q4W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 400 mg Q4W.
Subjects received two injections of Placebo every four weeks in between the two injections of 200 mg CZP to maintain the study blind."
633496|NCT01087788|E1|Reported Event|All CZP 200 mg Q2W|"This arm includes all subjects who were randomized to CZP 200 mg Q2W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 200 mg Q2W.
Subjects received one injection of 200 mg CZP and one injection of Placebo every two weeks to maintain the study blind."
633497|NCT01087801|B3|Baseline|Total|Total of all reporting groups
633498|NCT01087801|B2|Baseline|Placebo|Saline for Injection 0.1 mL/kg IV
633499|NCT01087801|B1|Baseline|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
633500|NCT01087801|P2|Participant Flow|Placebo|Saline for Injection 0.1 mL/kg IV
633501|NCT01087801|P1|Participant Flow|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
633502|NCT01087801|O2|Outcome|Placebo|Saline for Injection 0.1 mL/kg IV
633503|NCT01087801|O1|Outcome|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
633504|NCT01087801|E2|Reported Event|Placebo|Saline for Injection 0.1 mL/kg IV
633505|NCT01087801|E1|Reported Event|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
633506|NCT01087814|B3|Baseline|Total|Total of all reporting groups
633507|NCT01087814|B2|Baseline|Over-encapsulated Efavirenz|Both arms received both versions of the drug over the course of the study.
633508|NCT01087814|B1|Baseline|Efavirenz|Both arms received both versions of the drug during the course of the study.
633509|NCT01087814|P2|Participant Flow|Over-encapsulated Efavirenz First, Then Efavirenz|This arm received over-encapsulated efavirenz for five days, then efavirenz for five days.
633510|NCT01087814|P1|Participant Flow|Efavirenz First, Then Over-encapsulated Efavirenz|This arm received efavirenz for five days, then over-encapsulated efavirenz for five days.
644911|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
633515|NCT01088646|B1|Baseline|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
633516|NCT01088646|P1|Participant Flow|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
633517|NCT01088646|O1|Outcome|Pillcam Express Capsule Delivery System|The delivery system is comprised of three parts: a catheter, a syringe and a capsule holder.
633518|NCT01088646|E1|Reported Event|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
633519|NCT01088672|B1|Baseline|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke
Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
633520|NCT01088672|P1|Participant Flow|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke
Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
633562|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633521|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke
Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
633522|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke
Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
633523|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke
Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
633524|NCT01088672|E1|Reported Event|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke
Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
633525|NCT01088711|B5|Baseline|Total|Total of all reporting groups
633526|NCT01088711|B4|Baseline|T2D - Placebo|Obese T2D participants received once-weekly placebo for 4 weeks.
633527|NCT01088711|B3|Baseline|T2D - Omarigliptin|Obese T2D participants received once-weekly omarigliptin for 4 weeks.
633528|NCT01088711|B2|Baseline|T2D Participants (Panel B)|Obese participants with T2D received once-weekly omarigliptin or placebo for 4 weeks.
633529|NCT01088711|B1|Baseline|Healthy Participants - Omarigliptin|Obese healthy participants received once-weekly omarigliptin for 4 weeks.
633530|NCT01088711|P4|Participant Flow|T2D - Placebo|Obese T2D participants received once-weekly placebo for 4 weeks.
633531|NCT01088711|P3|Participant Flow|T2D - Omarigliptin|Obese T2D participants received once-weekly omarigliptin for 4 weeks.
633532|NCT01088711|P2|Participant Flow|Healthy - Placebo|Obese healthy participants received once-weekly placebo for 4 weeks.
633533|NCT01088711|P1|Participant Flow|Healthy Participants - Omarigliptin|Obese healthy participants received once-weekly omarigliptin for 4 weeks.
633534|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
633535|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
633536|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
633537|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
633538|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
633539|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
633540|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
633541|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
633542|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
633543|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
633544|NCT01088711|O4|Outcome|T2D Placebo|Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
633545|NCT01088711|O3|Outcome|T2D Omarigliptin|Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
633546|NCT01088711|O2|Outcome|Healthy Placebo|Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
633547|NCT01088711|O1|Outcome|Healthy Omarigliptin|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
633548|NCT01088711|O4|Outcome|T2D Placebo|Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
633908|NCT01089595|O2|Outcome|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
633549|NCT01088711|O3|Outcome|T2D Omarigliptin|Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
633550|NCT01088711|O2|Outcome|Healthy Placebo|Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
633551|NCT01088711|O1|Outcome|Healthy Omarigliptin|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
633552|NCT01088711|E4|Reported Event|Placebo T2D (Panel B)|Obese T2D participants received once-weekly placebo for 4 weeks.
633553|NCT01088711|E3|Reported Event|Omarigliptin 50 mg T2D (Panel B)|Obese T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
633554|NCT01088711|E2|Reported Event|Placebo Healthy (Panel A)|Obese healthy participants received once-weekly placebo for 4 weeks.
633555|NCT01088711|E1|Reported Event|Omarigliptin 50 mg Healthy (Panel A)|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks.
633556|NCT01088984|B3|Baseline|Total|Total of all reporting groups
633557|NCT01088984|B2|Baseline|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633558|NCT01088984|B1|Baseline|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633559|NCT01088984|P2|Participant Flow|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
637758|NCT01091116|E4|Reported Event|Single High Dose|one dose+placebo
633563|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633564|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633565|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633566|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633567|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633568|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633569|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633570|NCT01088984|O3|Outcome|Total|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633571|NCT01088984|O2|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633572|NCT01088984|O1|Outcome|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633573|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633574|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633575|NCT01088984|O1|Outcome|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633576|NCT01088984|E1|Reported Event|Bendamustine|Bendamustine 90 or 120 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
633577|NCT01088997|B3|Baseline|Total|Total of all reporting groups
633578|NCT01088997|B2|Baseline|Low Dose Milrinone|Subjects received a 20mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2mcg/kg over 24 hours
633769|NCT01089543|P4|Participant Flow|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
633579|NCT01088997|B1|Baseline|High Dose Milrinone|Subjects received a 50mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5mcg/kg over 24 hours
633580|NCT01088997|P2|Participant Flow|Low Dose Milrinone|Subjects received a 20 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2 mcg/kg/min over 24 hours.
633581|NCT01088997|P1|Participant Flow|High Dose Milrinone|Subjects received a 50 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5 mcg/kg/min over 24 hours.
633582|NCT01088997|O2|Outcome|Low Dose Milrinone|5 subjects were enrolled into the study, of these 2 completed study treatment and only 1 received 2 MPI measurements
633583|NCT01088997|O1|Outcome|High Dose Milrinone|7 subjects were enrolled into the study, of these 4 completed study treatment.
633584|NCT01088997|O1|Outcome|Milrinone Population|Population model developed based on 6 subjects who completed study treatment and were deemed evaluable.
633585|NCT01088997|O2|Outcome|Low Dose Milrinone|5 subjects were enrolled into this arm, of these only 2 completed study treatment.
633586|NCT01088997|O1|Outcome|High Dose Milrinone|7 subjects were enrolled into this arm, of these only 4 completed study treatment.
633587|NCT01088997|E2|Reported Event|Low Dose Milrinone|Subjects received a bolus intravenous (IV) infusion of 20 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.2 mcg/kg/min milrinone lactate over 24 hours.
633588|NCT01088997|E1|Reported Event|High Dose Milrinone|Subjects received a bolus intravenous (IV) infusion of 50 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.5 mcg/kg/min milrinone lactate over 24 hours.
633589|NCT01089023|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
633590|NCT01089023|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenous (IV) infusion, once every 4 weeks for a total of 6 infusions.
633591|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
633592|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
633593|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
633597|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
633598|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
633599|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
633600|NCT01089023|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions.
633601|NCT01089062|B7|Baseline|Total|Total of all reporting groups
633602|NCT01089062|B6|Baseline|Treatment C, Then B, Then A|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
633603|NCT01089062|B5|Baseline|Treatment C, Then A, Then B|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
633604|NCT01089062|B4|Baseline|Treatment B, Then C, Then A|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
633605|NCT01089062|B3|Baseline|Treatment B, Then A, Then C|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
633606|NCT01089062|B2|Baseline|Treatment A, Then C, Then B|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
633607|NCT01089062|B1|Baseline|Treatment A, Then B, Then C|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
633608|NCT01089062|P6|Participant Flow|Treatment C, Then B, Then A|"The second dose in each treatment group (C,B,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4."
633609|NCT01089062|P5|Participant Flow|Treatment C, Then A, Then B|"The second dose in each treatment group (C,A,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4."
633701|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
633909|NCT01089595|O1|Outcome|Nilotinib|Nilotinib 400 mg po bid
633610|NCT01089062|P4|Participant Flow|Treatment B, Then C, Then A|"The second dose in each treatment group (B,C,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4."
633611|NCT01089062|P3|Participant Flow|Treatment B, Then A, Then C|"The second dose in each treatment group (B,A,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4."
633612|NCT01089062|P2|Participant Flow|Treatment A, Then C, Then B|"The second dose in each treatment group (A,C,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4."
633613|NCT01089062|P1|Participant Flow|Treatment A, Then B, Then C|"The second dose in each treatment group (A,B,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment A = inhaler placebo and Intravenous (IV) Dihydroergotamine (DHE) for first dose, inhaler placebo for second dose at Visit 2.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4."
633614|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
633615|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
633616|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
633617|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
633618|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
633619|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
633620|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
633621|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
633926|NCT01089751|P2|Participant Flow|Placebo|Placebo once daily on an empty stomach for 14 weeks.
633622|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose 2 hours from time of first dose.
633623|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
633624|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
633625|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
633626|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
633627|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
633628|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
633629|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
633630|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
633631|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
633632|NCT01089062|E3|Reported Event|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
633633|NCT01089062|E2|Reported Event|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
633634|NCT01089062|E1|Reported Event|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
633635|NCT01089127|B7|Baseline|Total|Total of all reporting groups
633636|NCT01089127|B6|Baseline|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633637|NCT01089127|B5|Baseline|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633638|NCT01089127|B4|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633702|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
633703|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
633639|NCT01089127|B3|Baseline|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633640|NCT01089127|B2|Baseline|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633641|NCT01089127|B1|Baseline|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633642|NCT01089127|P6|Participant Flow|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633643|NCT01089127|P5|Participant Flow|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633644|NCT01089127|P4|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633645|NCT01089127|P3|Participant Flow|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633646|NCT01089127|P2|Participant Flow|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633647|NCT01089127|P1|Participant Flow|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633648|NCT01089127|O6|Outcome|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633649|NCT01089127|O5|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633650|NCT01089127|O4|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633651|NCT01089127|O3|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633704|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
644912|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
633652|NCT01089127|O2|Outcome|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633653|NCT01089127|O1|Outcome|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633654|NCT01089127|O6|Outcome|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633655|NCT01089127|O5|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633656|NCT01089127|O4|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633657|NCT01089127|O3|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633658|NCT01089127|O2|Outcome|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633659|NCT01089127|O1|Outcome|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633660|NCT01089127|E6|Reported Event|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633661|NCT01089127|E5|Reported Event|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633662|NCT01089127|E4|Reported Event|Indacaterol 150 ug|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633663|NCT01089127|E3|Reported Event|Indacaterol 75 ug|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633664|NCT01089127|E2|Reported Event|Indacaterol 37.5 ug|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633705|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
644913|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
633665|NCT01089127|E1|Reported Event|Indacaterol 18.75 ug|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
633666|NCT01089231|B5|Baseline|Total|Total of all reporting groups
633667|NCT01089231|B4|Baseline|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
633668|NCT01089231|B3|Baseline|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
633669|NCT01089231|B2|Baseline|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
633670|NCT01089231|B1|Baseline|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
633671|NCT01089231|P4|Participant Flow|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
633672|NCT01089231|P3|Participant Flow|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
633673|NCT01089231|P2|Participant Flow|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
633674|NCT01089231|P1|Participant Flow|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
633675|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
633676|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
633677|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
633678|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
633679|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
633680|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
637759|NCT01091116|E3|Reported Event|High Dose|two doses
633683|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
633684|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
633685|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
633686|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
633687|NCT01089231|E4|Reported Event|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
633688|NCT01089231|E3|Reported Event|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
633689|NCT01089231|E2|Reported Event|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
633690|NCT01089231|E1|Reported Event|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
633691|NCT01089361|B3|Baseline|Total|Total of all reporting groups
633692|NCT01089361|B2|Baseline|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
633693|NCT01089361|B1|Baseline|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
633694|NCT01089361|P2|Participant Flow|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
633695|NCT01089361|P1|Participant Flow|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
633696|NCT01089361|O2|Outcome|Ketamine|"The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
Ketamine: The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours."
633697|NCT01089361|O1|Outcome|Normal Saline Placebo|"The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
Normal Saline placebo: The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours."
633698|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
633699|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
633700|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
644914|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
633706|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
633707|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
633708|NCT01089361|O2|Outcome|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
633709|NCT01089361|O1|Outcome|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
633710|NCT01089361|E2|Reported Event|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
633711|NCT01089361|E1|Reported Event|Normal Saline|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
633712|NCT01089413|B4|Baseline|Total|Total of all reporting groups
633713|NCT01089413|B3|Baseline|Bevacizumab: Age >80 Years|Participants aged greater than (>) 80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633714|NCT01089413|B2|Baseline|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633715|NCT01089413|B1|Baseline|Bevacizumab: Age <70 Years|Participants aged less than (<) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633716|NCT01089413|P1|Participant Flow|Bevacizumab: Overall|All participants with Metastatic Colorectal Cancer (mCRC) for whom the physician decided to prescribe bevacizumab (Avastin) as part of their first line treatment and in line with current Summary of Product Characteristics (SmPC) (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633734|NCT01089504|B1|Baseline|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
633717|NCT01089413|O4|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633718|NCT01089413|O3|Outcome|Bevacizumab: Age >80 Years|Participants aged >80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633719|NCT01089413|O2|Outcome|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633720|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged <70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633721|NCT01089413|O4|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633722|NCT01089413|O3|Outcome|Bevacizumab: Age >80 Years|Participants aged >80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633723|NCT01089413|O2|Outcome|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633724|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged <70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633725|NCT01089413|O3|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633767|NCT01089543|B2|Baseline|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
633768|NCT01089543|B1|Baseline|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
633726|NCT01089413|O2|Outcome|Bevacizumab: Age ≥70 Years|Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged >80 years, the age groups “70-80 Years” and “>80 Years” have been pooled in this group.
633727|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged < 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633728|NCT01089413|O3|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633729|NCT01089413|O2|Outcome|Bevacizumab: Age ≥70 Years|Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged >80 years, the age groups “70-80 Years” and “>80 Years” have been pooled in this group.
633730|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged < 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633731|NCT01089413|E1|Reported Event|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
633732|NCT01089504|B3|Baseline|Total|Total of all reporting groups
633733|NCT01089504|B2|Baseline|Placebo|"Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
637760|NCT01091116|E2|Reported Event|Mid Dose|two doses
633735|NCT01089504|P2|Participant Flow|Placebo|"Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
633736|NCT01089504|P1|Participant Flow|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
633737|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
633738|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
633739|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
633740|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
633741|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
633742|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
633743|NCT01089504|E2|Reported Event|Placebo|"Placebo in a volume equivalent to active drug for 4 months
placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
633744|NCT01089504|E1|Reported Event|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months
phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
633745|NCT01089517|B4|Baseline|Total|Total of all reporting groups
633746|NCT01089517|B3|Baseline|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
633747|NCT01089517|B2|Baseline|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
633748|NCT01089517|B1|Baseline|Lucentis|Sham/Lucentis 0.5 mg
633749|NCT01089517|P3|Participant Flow|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
633750|NCT01089517|P2|Participant Flow|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
633751|NCT01089517|P1|Participant Flow|Lucentis|Sham/Lucentis 0.5 mg
633752|NCT01089517|O3|Outcome|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
633753|NCT01089517|O2|Outcome|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
633754|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
633755|NCT01089517|O3|Outcome|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
633756|NCT01089517|O2|Outcome|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
633757|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
633758|NCT01089517|O3|Outcome|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
633759|NCT01089517|O2|Outcome|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
633760|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
633761|NCT01089517|E3|Reported Event|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
633762|NCT01089517|E2|Reported Event|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
633763|NCT01089517|E1|Reported Event|Lucentis|Sham/Lucentis 0.5 mg
633764|NCT01089543|B5|Baseline|Total|Total of all reporting groups
633765|NCT01089543|B4|Baseline|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
633766|NCT01089543|B3|Baseline|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
633770|NCT01089543|P3|Participant Flow|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
633771|NCT01089543|P2|Participant Flow|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
633772|NCT01089543|P1|Participant Flow|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
633773|NCT01089543|O4|Outcome|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
633774|NCT01089543|O3|Outcome|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
633775|NCT01089543|O2|Outcome|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
633776|NCT01089543|O1|Outcome|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
633777|NCT01089543|O4|Outcome|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
633778|NCT01089543|O3|Outcome|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
633779|NCT01089543|O2|Outcome|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
633780|NCT01089543|O1|Outcome|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
633781|NCT01089543|E4|Reported Event|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
633782|NCT01089543|E3|Reported Event|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
633783|NCT01089543|E2|Reported Event|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
633784|NCT01089543|E1|Reported Event|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
633785|NCT01089556|B3|Baseline|Total|Total of all reporting groups
633786|NCT01089556|B2|Baseline|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633787|NCT01089556|B1|Baseline|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633788|NCT01089556|P6|Participant Flow|Pregabalin (SP III)|Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
633789|NCT01089556|P5|Participant Flow|PGB + DLX (SP III)|Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
633790|NCT01089556|P4|Participant Flow|DLX + PGB (SP III)|Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
633791|NCT01089556|P3|Participant Flow|Duloxetine (SP III)|Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
633792|NCT01089556|P2|Participant Flow|Pregabalin (SP II)|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633793|NCT01089556|P1|Participant Flow|Duloxetine (SP II)|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
633794|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633795|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633796|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633797|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633798|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633799|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633800|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633801|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633802|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633803|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633804|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633805|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633806|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633865|NCT01089569|B1|Baseline|Exenatide|"5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
Exenatide: refer to Arm detail"
633906|NCT01089595|P2|Participant Flow|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
633807|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633808|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633809|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633810|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633811|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633812|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633813|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633814|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633815|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633816|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633817|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633818|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633883|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
637761|NCT01091116|E1|Reported Event|Low Dose|two doses
633819|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633820|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633821|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633822|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633823|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633824|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633825|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633826|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633827|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633828|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633829|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633830|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633831|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633832|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633833|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633834|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633904|NCT01089595|B2|Baseline|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
633835|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633836|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633837|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633838|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633839|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633840|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633841|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633842|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633843|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633844|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633845|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633846|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633847|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633848|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633849|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633850|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633851|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633852|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633853|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
633854|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
633855|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
633856|NCT01089556|E6|Reported Event|Pregabalin (SP III)|Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
633857|NCT01089556|E5|Reported Event|PGB + DLX (SP III)|Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
633858|NCT01089556|E4|Reported Event|DLX + PGB (SP III)|Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
633859|NCT01089556|E3|Reported Event|Duloxetine (SP III)|Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
633860|NCT01089556|E2|Reported Event|Pregabalin (SP II)|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
633861|NCT01089556|E1|Reported Event|Duloxetine (SP II)|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
633862|NCT01089569|B4|Baseline|Total|Total of all reporting groups
633863|NCT01089569|B3|Baseline|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
633864|NCT01089569|B2|Baseline|Insulin Glargine|".1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
Insulin Glargine: refer to Arm detail"
633905|NCT01089595|B1|Baseline|Nilotinib|Nilotinib 400 mg po bid
633866|NCT01089569|P3|Participant Flow|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
633867|NCT01089569|P2|Participant Flow|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
633868|NCT01089569|P1|Participant Flow|Exenatide|5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
633869|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
633870|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
633871|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
633872|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
633873|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
633874|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
633875|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
633876|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
633877|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
633878|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
633879|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
633880|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
633881|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
633882|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
633884|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
633885|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
633886|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
633887|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
633888|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
633889|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
633890|NCT01089569|E3|Reported Event|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
633891|NCT01089569|E2|Reported Event|Insulin Glargine|".1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
Insulin Glargine: refer to Arm detail"
633892|NCT01089569|E1|Reported Event|Exenatide|"5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
Exenatide: refer to Arm detail"
633893|NCT01089582|B1|Baseline|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
633894|NCT01089582|P1|Participant Flow|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
633895|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
633896|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
633897|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
633898|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
633899|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
633900|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
633901|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
633902|NCT01089582|E1|Reported Event|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
633903|NCT01089595|B3|Baseline|Total|Total of all reporting groups
633907|NCT01089595|P1|Participant Flow|Nilotinib|Nilotinib 400 mg po bid
633910|NCT01089595|O2|Outcome|Nilotinib + Imatinib|Nilotinib 400 mg twice daily (BID) with Imatinib 400 mg daily
633911|NCT01089595|O1|Outcome|Nilotinib|Nilotinib 400 mg by mouth (PO), twice daily (BID)
633912|NCT01089595|E2|Reported Event|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
633913|NCT01089595|E1|Reported Event|Nilotinib|Nilotinib 400 mg po bid
633914|NCT01089608|B3|Baseline|Total|Total of all reporting groups
633915|NCT01089608|B2|Baseline|Azithromycin|"Eye drops Single dose unit
Azithromycin: Eye drops, Dosage : 1.5%
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
633916|NCT01089608|B1|Baseline|Unifluid|"Eye drops in Single Dose Unit
Povidone: Eye drops Single dose unit
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
633917|NCT01089608|P2|Participant Flow|Azithromycin|"Eye drops Single dose unit
Azithromycin: Eye drops, Dosage : 1.5%
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
633918|NCT01089608|P1|Participant Flow|Unifluid|"Eye drops in Single Dose Unit
Povidone: Eye drops Single dose unit
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
633919|NCT01089608|O2|Outcome|Azithromycin|"Eye drops Single dose unit
Azithromycin: Eye drops, Dosage : 1.5%
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
633920|NCT01089608|O1|Outcome|Unifluid|"Eye drops in Single Dose Unit
Povidone: Eye drops Single dose unit
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
633921|NCT01089608|E2|Reported Event|Azithromycin|"Eye drops Single dose unit
Azithromycin: Eye drops, Dosage : 1.5%
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
633922|NCT01089608|E1|Reported Event|Unifluid|"Eye drops in Single Dose Unit
Povidone: Eye drops Single dose unit
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
633923|NCT01089751|B3|Baseline|Total|Total of all reporting groups
633924|NCT01089751|B2|Baseline|Placebo|Placebo once daily on an empty stomach for 14 weeks.
633925|NCT01089751|B1|Baseline|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
633927|NCT01089751|P1|Participant Flow|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
633928|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
633929|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
633930|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
633931|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
633932|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
633933|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
633934|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
633935|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
633936|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
633937|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
633938|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
633939|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
633940|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
633941|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
633942|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
633943|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
633944|NCT01089751|E2|Reported Event|Placebo|Placebo once daily on an empty stomach for 14 weeks.
633945|NCT01089751|E1|Reported Event|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
633946|NCT01090011|B1|Baseline|Total Patients|"All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a 3+3 Up-and-Down trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events."
633947|NCT01090011|P1|Participant Flow|Total Patients|"All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a 3+3 Up-and-Down trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events."
633948|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
634106|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
634107|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
633949|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg (Afa40 Mono)"
633950|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633951|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633952|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633953|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg (Afa40 Mono)"
633954|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633955|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633956|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633957|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg (Afa40 Mono)"
633958|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
634076|NCT01090180|B2|Baseline|Arm 2: Placebo|Placebo (sugar pill): inactive
636389|NCT01077284|B3|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
633959|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633960|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633961|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg (Afa40 Mono)"
633962|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633963|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633964|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633965|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg (Afa40 Mono)"
633966|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633967|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633968|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633969|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633970|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633971|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
634108|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
633972|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633973|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633974|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633975|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633976|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633977|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633978|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633979|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633980|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633981|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633982|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633983|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633984|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633985|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg (Afa40 Mono)"
633986|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633987|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633988|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633989|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg (Afa40 Mono)"
633990|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633991|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
633992|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633993|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg (Afa40 Mono)"
633994|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633995|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
634109|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
633996|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633997|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg (Afa40 Mono)"
633998|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
633999|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
634000|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
634001|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg (Afa40 Mono)"
634002|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
634003|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
634004|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
634072|NCT01090102|O1|Outcome|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
634005|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)
Afatinib 40 mg (Afa40 Mono)"
634006|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
634007|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
634008|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
634009|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib)
Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
634010|NCT01090011|E4|Reported Event|Sequential Arm - Combination Therapy (Afa40+Ctx500)|Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
634011|NCT01090011|E3|Reported Event|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
634012|NCT01090011|E2|Reported Event|Combination Arm - Afa40+Ctx500|Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
634013|NCT01090011|E1|Reported Event|Combination Arm - Afa40+Ctx250|Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
634014|NCT01090050|B3|Baseline|Total|Total of all reporting groups
634015|NCT01090050|B2|Baseline|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to naproxen will treat daily with 1 tablet naproxen 500mg per day x 30 days. Subjects will be provided with 30 tablets of naproxen 500mg for rescue. In Treatment Period Months 2 and 3: Subjects randomized to naproxen will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of naproxen 500mg per month for rescue.
634016|NCT01090050|B1|Baseline|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Treximet will treat daily with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Treximet for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Treximet will be provided with 14 tablets of Treximet to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Treximet per month for rescue.
634017|NCT01090050|P2|Participant Flow|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
634018|NCT01090050|P1|Participant Flow|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
634019|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500 mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
634020|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85 mg / naproxen sodium 500 mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
634021|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500 mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
634022|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85 mg / naproxen sodium 500 mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
634073|NCT01090102|E2|Reported Event|Placebo|Placebo: Four placebo capsules once daily (1.5g/d) PO (by mouth).
640758|NCT01103414|B6|Baseline|Total|Total of all reporting groups
634023|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
634024|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
634025|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
634026|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
634027|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
634028|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
634029|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
634030|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
634110|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
634111|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
634031|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
634032|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
634033|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
634034|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen will treat daily with 1 tablet Sumatriptan/Naproxen per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen will be provided with 14 tablets of Sumatriptan/Naproxen to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen per month for rescue.
634035|NCT01090050|E2|Reported Event|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
634074|NCT01090102|E1|Reported Event|Mesalamine|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) PO(by mouth).
634075|NCT01090180|B3|Baseline|Total|Total of all reporting groups
634036|NCT01090050|E1|Reported Event|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
634037|NCT01090063|B1|Baseline|Main|
634038|NCT01090063|P1|Participant Flow|Main|All participants were treated the same
634039|NCT01090063|O1|Outcome|Number of Participants With AEs|
634040|NCT01090063|O2|Outcome|Mean Week 24 Pain VAS Score|Average score of the pain VAS at Week 24. 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
634041|NCT01090063|O1|Outcome|Mean Baseline Pain VAS Score|Average score of the pain VAS at baseline. 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
634042|NCT01090063|O2|Outcome|Mean Week 24 Pruritus VAS Score|Average pruritus VAS score as measured at week 24. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
634043|NCT01090063|O1|Outcome|Mean Baseline Pruritus VAS Score|Average pruritus VAS score as measured at baseline. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
634044|NCT01090063|O2|Outcome|Mean Week 24 Fissure Count|Average number of fissures found on hands and feet at Week 24
634045|NCT01090063|O1|Outcome|Mean Baseline Fissure Count|Average number of fissures found on hands and feet at baseline
634046|NCT01090063|O2|Outcome|Mean Pustule Count at Week 24|Average number of pustules present in all subjects at week 24
634047|NCT01090063|O1|Outcome|Mean Pustule Count at Baseline|Average number of pustules present in all subjects at baseline
634048|NCT01090063|O1|Outcome|Median PGA|Median PGA at Week 24
634049|NCT01090063|O1|Outcome|Main|Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.
634050|NCT01090063|E1|Reported Event|Main|
634051|NCT01090076|B3|Baseline|Total|Total of all reporting groups
634052|NCT01090076|B2|Baseline|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
634053|NCT01090076|B1|Baseline|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
634054|NCT01090076|P2|Participant Flow|Placebo|Placebo x 2 sachets/d
634055|NCT01090076|P1|Participant Flow|Abound|Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)
634056|NCT01090076|O2|Outcome|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
634057|NCT01090076|O1|Outcome|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
634058|NCT01090076|O2|Outcome|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
634059|NCT01090076|O1|Outcome|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
634060|NCT01090076|O2|Outcome|Placebo|Placebo x 2 sachets/d
634061|NCT01090076|O1|Outcome|Abound|Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)
634276|NCT01090765|O1|Outcome|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
634062|NCT01090076|E2|Reported Event|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
634063|NCT01090076|E1|Reported Event|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
634064|NCT01090102|B3|Baseline|Total|Total of all reporting groups
634065|NCT01090102|B2|Baseline|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
634066|NCT01090102|B1|Baseline|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
634067|NCT01090102|P2|Participant Flow|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
634068|NCT01090102|P1|Participant Flow|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
634069|NCT01090102|O2|Outcome|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
634070|NCT01090102|O1|Outcome|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
634071|NCT01090102|O2|Outcome|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
641410|NCT01098032|B3|Baseline|Total|Total of all reporting groups
634077|NCT01090180|B1|Baseline|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
634078|NCT01090180|P2|Participant Flow|Arm 2: Placebo|Placebo (sugar pill): inactive
634079|NCT01090180|P1|Participant Flow|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
634080|NCT01090180|O2|Outcome|Arm 2: Placebo|Placebo (sugar pill): inactive
634081|NCT01090180|O1|Outcome|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
634082|NCT01090180|O2|Outcome|Arm 2: Placebo|Placebo (sugar pill): inactive
634083|NCT01090180|O1|Outcome|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
634084|NCT01090180|E2|Reported Event|Arm 2: Placebo|Placebo (sugar pill): inactive
634085|NCT01090180|E1|Reported Event|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
634086|NCT01090310|B5|Baseline|Total|Total of all reporting groups
634087|NCT01090310|B4|Baseline|Placebo|Placebo s.c. every 2 weeks
634088|NCT01090310|B3|Baseline|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634089|NCT01090310|B2|Baseline|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634090|NCT01090310|B1|Baseline|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
634091|NCT01090310|P4|Participant Flow|Placebo|Placebo s.c. every 2 weeks
634092|NCT01090310|P3|Participant Flow|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634093|NCT01090310|P2|Participant Flow|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634094|NCT01090310|P1|Participant Flow|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
634095|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
634096|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634097|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634098|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
634099|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
634100|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634101|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634102|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
634103|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
634104|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634105|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634112|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634113|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
634114|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
634115|NCT01090310|E4|Reported Event|Placebo Every 2 Weeks|Placebo every 2 weeks
634116|NCT01090310|E3|Reported Event|AIN457 150mg Every 4 Weeks|AIN457 150mg every 4 weeks
634117|NCT01090310|E2|Reported Event|AIN457 300mg Every 4 Weeks|AIN457 300mg every 4 weeks
634118|NCT01090310|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300mg every 2 weeks
634119|NCT01090323|B3|Baseline|Total|Total of all reporting groups
634120|NCT01090323|B2|Baseline|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
634121|NCT01090323|B1|Baseline|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
634122|NCT01090323|P2|Participant Flow|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
634123|NCT01090323|P1|Participant Flow|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
634124|NCT01090323|O2|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
634125|NCT01090323|O1|Outcome|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
634126|NCT01090323|O2|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
634127|NCT01090323|O1|Outcome|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
634128|NCT01090323|E2|Reported Event|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
634129|NCT01090323|E1|Reported Event|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
634130|NCT01090427|B4|Baseline|Total|Total of all reporting groups
634131|NCT01090427|B3|Baseline|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634132|NCT01090427|B2|Baseline|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634133|NCT01090427|B1|Baseline|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
634134|NCT01090427|P7|Participant Flow|Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
634135|NCT01090427|P6|Participant Flow|Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
634136|NCT01090427|P5|Participant Flow|Placebo -> Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
634137|NCT01090427|P4|Participant Flow|Placebo -> Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
634138|NCT01090427|P3|Participant Flow|Ustekinumab Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
634139|NCT01090427|P2|Participant Flow|Ustekinumab Half-Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
634140|NCT01090427|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
634141|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634142|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634143|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
634277|NCT01090765|O1|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
634144|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634145|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634146|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
634147|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634148|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634149|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
634150|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634151|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634152|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
634153|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634487|NCT01079598|E1|Reported Event|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
634154|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634155|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
634156|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634157|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634158|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
634159|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634160|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634161|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
634162|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634163|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
634164|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
634165|NCT01090427|E7|Reported Event|Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
634166|NCT01090427|E6|Reported Event|Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
634167|NCT01090427|E5|Reported Event|Placebo -> Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
634278|NCT01090765|E6|Reported Event|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
634168|NCT01090427|E4|Reported Event|Placebo -> Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
634169|NCT01090427|E3|Reported Event|Ustekinumab Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
634170|NCT01090427|E2|Reported Event|Ustekinumab Half-Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
634171|NCT01090427|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
634172|NCT01090453|B3|Baseline|Total|Total of all reporting groups
634173|NCT01090453|B2|Baseline|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634174|NCT01090453|B1|Baseline|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634175|NCT01090453|P2|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634292|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
634176|NCT01090453|P1|Participant Flow|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634177|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634178|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634179|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634180|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634181|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634182|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634183|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634234|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634184|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634185|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634186|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634187|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634188|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634293|NCT01090973|E1|Reported Event|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
634189|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634190|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634191|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634192|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634193|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634194|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634195|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634196|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634210|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
644915|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
634197|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634198|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634199|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634200|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634241|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634294|NCT01079130|B7|Baseline|Total|Total of all reporting groups
634488|NCT01079806|B3|Baseline|Total|Total of all reporting groups
634201|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634202|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634203|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634204|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634205|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634206|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634207|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634208|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634209|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634233|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634273|NCT01090765|O4|Outcome|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
634211|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634212|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634213|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634214|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634215|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634216|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634217|NCT01090453|E2|Reported Event|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634218|NCT01090453|E1|Reported Event|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
634219|NCT01090479|B3|Baseline|Total|Total of all reporting groups
634220|NCT01090479|B2|Baseline|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
634221|NCT01090479|B1|Baseline|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
634222|NCT01090479|P2|Participant Flow|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
634223|NCT01090479|P1|Participant Flow|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
634224|NCT01090479|O2|Outcome|Chlorhexidine|
634225|NCT01090479|O1|Outcome|Control|
634226|NCT01090479|E2|Reported Event|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
634227|NCT01090479|E1|Reported Event|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
634228|NCT01090739|B1|Baseline|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634229|NCT01090739|P1|Participant Flow|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634230|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
634231|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
634232|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
634274|NCT01090765|O3|Outcome|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
634275|NCT01090765|O2|Outcome|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
634235|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634236|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634237|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634238|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634239|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634240|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634291|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
634242|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634243|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634244|NCT01090739|E1|Reported Event|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
634245|NCT01090752|B3|Baseline|Total|Total of all reporting groups
634246|NCT01090752|B2|Baseline|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
634247|NCT01090752|B1|Baseline|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
634248|NCT01090752|P2|Participant Flow|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
634249|NCT01090752|P1|Participant Flow|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
634250|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
634251|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
634252|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
634253|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
634254|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
634255|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
634256|NCT01090752|E2|Reported Event|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
634257|NCT01090752|E1|Reported Event|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
634258|NCT01090765|B7|Baseline|Total|Total of all reporting groups
634259|NCT01090765|B6|Baseline|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
634260|NCT01090765|B5|Baseline|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
634261|NCT01090765|B4|Baseline|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
634262|NCT01090765|B3|Baseline|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
634263|NCT01090765|B2|Baseline|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
634264|NCT01090765|B1|Baseline|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
634265|NCT01090765|P6|Participant Flow|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
634266|NCT01090765|P5|Participant Flow|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
634267|NCT01090765|P4|Participant Flow|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
634268|NCT01090765|P3|Participant Flow|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
634269|NCT01090765|P2|Participant Flow|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
634270|NCT01090765|P1|Participant Flow|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
634271|NCT01090765|O6|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
634272|NCT01090765|O5|Outcome|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
634279|NCT01090765|E5|Reported Event|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
634280|NCT01090765|E4|Reported Event|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
634281|NCT01090765|E3|Reported Event|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
634282|NCT01090765|E2|Reported Event|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
634283|NCT01090765|E1|Reported Event|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
634284|NCT01090973|B1|Baseline|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
634285|NCT01090973|P1|Participant Flow|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
634286|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
634287|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
634288|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
634289|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
634290|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
636534|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
634295|NCT01079130|B6|Baseline|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634296|NCT01079130|B5|Baseline|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634297|NCT01079130|B4|Baseline|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634298|NCT01079130|B3|Baseline|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634299|NCT01079130|B2|Baseline|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634300|NCT01079130|B1|Baseline|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
634301|NCT01079130|P6|Participant Flow|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634302|NCT01079130|P5|Participant Flow|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634303|NCT01079130|P4|Participant Flow|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634304|NCT01079130|P3|Participant Flow|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634348|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634305|NCT01079130|P2|Participant Flow|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634306|NCT01079130|P1|Participant Flow|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
634307|NCT01079130|O6|Outcome|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634308|NCT01079130|O5|Outcome|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634309|NCT01079130|O4|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634310|NCT01079130|O3|Outcome|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634330|NCT01079143|P4|Participant Flow|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
636535|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
634311|NCT01079130|O2|Outcome|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634312|NCT01079130|O1|Outcome|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
634313|NCT01079130|O6|Outcome|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634314|NCT01079130|O5|Outcome|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634315|NCT01079130|O4|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634316|NCT01079130|O3|Outcome|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634317|NCT01079130|O2|Outcome|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634318|NCT01079130|O1|Outcome|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
634319|NCT01079130|E6|Reported Event|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634320|NCT01079130|E5|Reported Event|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634321|NCT01079130|E4|Reported Event|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634408|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
644916|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
634322|NCT01079130|E3|Reported Event|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634323|NCT01079130|E2|Reported Event|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
634324|NCT01079130|E1|Reported Event|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
634325|NCT01079143|B5|Baseline|Total|Total of all reporting groups
634326|NCT01079143|B4|Baseline|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634327|NCT01079143|B3|Baseline|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634328|NCT01079143|B2|Baseline|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634329|NCT01079143|B1|Baseline|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634331|NCT01079143|P3|Participant Flow|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634332|NCT01079143|P2|Participant Flow|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634333|NCT01079143|P1|Participant Flow|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634334|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634335|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634336|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634337|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634338|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634339|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634340|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634341|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634342|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634343|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634344|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634345|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634346|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634347|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634349|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634350|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634351|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634352|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634353|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634354|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634355|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634356|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634357|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634485|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
634358|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634359|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634360|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634361|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634362|NCT01079143|O2|Outcome|Neoral|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634363|NCT01079143|O1|Outcome|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634364|NCT01079143|O2|Outcome|Neoral|Between transplantation adn randomization, all patients have received Neoral. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic.
634365|NCT01079143|O1|Outcome|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634366|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634367|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634368|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634369|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634370|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634371|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634372|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634373|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634374|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634375|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634376|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634377|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634378|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634379|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634380|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634381|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634382|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634383|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634384|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634385|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634386|NCT01079143|O2|Outcome|No- No Fibrosis Progression|Participants who did not experience fibrosis progression based on IF/TA (univariate analysis)
634387|NCT01079143|O1|Outcome|Yes- Fibrosis Progression|Participants who experienced fibrosis progression based on IF/TA (univariate analysis)
634388|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634389|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634390|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634391|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634392|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634393|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634394|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634395|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634396|NCT01079143|O2|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634397|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634398|NCT01079143|E2|Reported Event|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
634399|NCT01079143|E1|Reported Event|Neoral|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
634400|NCT01079182|B1|Baseline|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634401|NCT01079182|P1|Participant Flow|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634402|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634403|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634404|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634405|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634406|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634407|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634409|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634410|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634411|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634412|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634413|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634414|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634415|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634416|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634417|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634418|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634419|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634420|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634421|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634422|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634423|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634424|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634425|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634426|NCT01079182|E1|Reported Event|Ankylosing Spondylitis|Participants with ankylosing spondylitis
634427|NCT01079195|B1|Baseline|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
634428|NCT01079195|P1|Participant Flow|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
634429|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
634430|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
634431|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
634432|NCT01079195|E1|Reported Event|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
634433|NCT01079234|B4|Baseline|Total|Total of all reporting groups
634434|NCT01079234|B3|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
634435|NCT01079234|B2|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
634436|NCT01079234|B1|Baseline|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
634437|NCT01079234|P4|Participant Flow|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
634438|NCT01079234|P3|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
634439|NCT01079234|P2|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
634440|NCT01079234|P1|Participant Flow|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
634519|NCT01079936|B5|Baseline|Total|Total of all reporting groups
634441|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
634442|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
634443|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
634444|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
634445|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
634446|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
634486|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
634447|NCT01079234|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
634448|NCT01079234|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
634449|NCT01079234|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
634450|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
634451|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
634452|NCT01079234|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
634453|NCT01079234|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
634454|NCT01079234|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
634455|NCT01079234|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
634456|NCT01079234|E1|Reported Event|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
634457|NCT01079299|B3|Baseline|Total|Total of all reporting groups
634458|NCT01079299|B2|Baseline|Standard Compression Alone|
634459|NCT01079299|B1|Baseline|IPC Plus Standard Compression|
634460|NCT01079299|P2|Participant Flow|Standard Compression Alone|
634461|NCT01079299|P1|Participant Flow|IPC Plus Standard Compression|
634462|NCT01079299|O2|Outcome|Standard Compression Alone|
634463|NCT01079299|O1|Outcome|IPC Plus Standard Compression|
634464|NCT01079299|E2|Reported Event|Standard Compression Alone|
634465|NCT01079299|E1|Reported Event|IPC Plus Standard Compression|
634466|NCT01079390|B4|Baseline|Total|Total of all reporting groups
634467|NCT01079390|B3|Baseline|Placebo Acupuncture|"sham acupuncture treatment will be applied
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634468|NCT01079390|B2|Baseline|Low Dose Acupuncture|"two needles will be applied.
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634469|NCT01079390|B1|Baseline|High Dose Acupuncture|"six needle applied during acupuncture
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634470|NCT01079390|P3|Participant Flow|Placebo Acupuncture|"sham acupuncture treatment will be applied
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634471|NCT01079390|P2|Participant Flow|Low Dose Acupuncture|"two needles will be applied.
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634472|NCT01079390|P1|Participant Flow|High Dose Acupuncture|"six needle applied during acupuncture
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634473|NCT01079390|O2|Outcome|Placebo Acupuncture|"sham acupuncture treatment will be applied
acupuncture : patient will receive sham acupuncture treatment."
634474|NCT01079390|O1|Outcome|Acupuncture|"six needle applied during acupuncture
acupuncture : patient will receive high or low dose."
634475|NCT01079390|O3|Outcome|Placebo Acupuncture|"sham acupuncture treatment will be applied
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634476|NCT01079390|O2|Outcome|Low Dose Acupuncture|"two needles will be applied.
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634477|NCT01079390|O1|Outcome|High Dose Acupuncture|"six needle applied during acupuncture
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634478|NCT01079390|E3|Reported Event|Placebo Acupuncture|"sham acupuncture treatment will be applied
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634479|NCT01079390|E2|Reported Event|Low Dose Acupuncture|"two needles will be applied.
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634480|NCT01079390|E1|Reported Event|High Dose Acupuncture|"six needle applied during acupuncture
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment."
634481|NCT01079598|B1|Baseline|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
634482|NCT01079598|P1|Participant Flow|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
634483|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
634484|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
634489|NCT01079806|B2|Baseline|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
634490|NCT01079806|B1|Baseline|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
634491|NCT01079806|P2|Participant Flow|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
634492|NCT01079806|P1|Participant Flow|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
634493|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
634494|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
634495|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
634496|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
634497|NCT01079806|O2|Outcome|Placebo|Placebo: Tablets/Oral Solution, Oral, 0 mg, once daily, 48-96 weeks, depending on response
634498|NCT01079806|O1|Outcome|Entecavir|Entecavir: Tablets/Oral Solution, Oral, 0.015 mg/kg up to 0.5 mg, once daily, 96-144 weeks, depending on response
634499|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
634500|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
634501|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
634502|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
634503|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
634504|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
634505|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
634506|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
634507|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
634508|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
634509|NCT01079806|E2|Reported Event|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
634510|NCT01079806|E1|Reported Event|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
634511|NCT01079832|B1|Baseline|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
634512|NCT01079832|P1|Participant Flow|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
634513|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
634514|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
634515|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
634516|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
634517|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
634518|NCT01079832|E1|Reported Event|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
634520|NCT01079936|B4|Baseline|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634521|NCT01079936|B3|Baseline|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634522|NCT01079936|B2|Baseline|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634523|NCT01079936|B1|Baseline|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634524|NCT01079936|P5|Participant Flow|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634525|NCT01079936|P4|Participant Flow|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634526|NCT01079936|P3|Participant Flow|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634527|NCT01079936|P2|Participant Flow|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634528|NCT01079936|P1|Participant Flow|Phase I: Lenalidomide + High-Dose Melphalan|Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634529|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634530|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
636536|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
634531|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634532|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634533|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634534|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634535|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634536|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634537|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634538|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634539|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634540|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634541|NCT01079936|O1|Outcome|Lenalidomide + High-Dose Melphalan|"Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
Lenalidomide: Beginning dose level 25 mg by mouth (PO) on Days -8 to -2
Melphalan: Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion
Stem Cell Infusion: Stem cell infusion on Day 0."
634542|NCT01079936|E4|Reported Event|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634543|NCT01079936|E3|Reported Event|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634544|NCT01079936|E2|Reported Event|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634545|NCT01079936|E1|Reported Event|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
634546|NCT01079949|B3|Baseline|Total|Total of all reporting groups
634547|NCT01079949|B2|Baseline|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634548|NCT01079949|B1|Baseline|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634549|NCT01079949|P2|Participant Flow|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634550|NCT01079949|P1|Participant Flow|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634623|NCT01079988|B3|Baseline|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
643028|NCT01107834|B3|Baseline|Total|Total of all reporting groups
634551|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634552|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634553|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634554|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634555|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634556|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634611|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634612|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634557|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634558|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634559|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634624|NCT01079988|B2|Baseline|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
634560|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634561|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634562|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634563|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634564|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634565|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634575|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634566|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634567|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634587|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634568|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634569|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634570|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634571|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634572|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634573|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634574|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634607|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634608|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634576|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634577|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634578|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634579|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634580|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634581|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634582|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634583|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634584|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634609|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634610|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634585|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634586|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634588|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634589|NCT01079949|E2|Reported Event|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634590|NCT01079949|E1|Reported Event|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
634591|NCT01079962|B3|Baseline|Total|Total of all reporting groups
634592|NCT01079962|B2|Baseline|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634593|NCT01079962|B1|Baseline|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634594|NCT01079962|P2|Participant Flow|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634595|NCT01079962|P1|Participant Flow|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634596|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634597|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634598|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634599|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634600|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634601|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634602|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634603|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634604|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634605|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634606|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634613|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634614|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634615|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634616|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634617|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634618|NCT01079962|E2|Reported Event|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
634619|NCT01079962|E1|Reported Event|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
634620|NCT01079988|B6|Baseline|Total|Total of all reporting groups
634621|NCT01079988|B5|Baseline|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.
Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
634622|NCT01079988|B4|Baseline|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
634656|NCT01080118|O1|Outcome|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
634625|NCT01079988|B1|Baseline|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
634626|NCT01079988|P5|Participant Flow|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.
Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
634627|NCT01079988|P4|Participant Flow|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
634628|NCT01079988|P3|Participant Flow|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
634629|NCT01079988|P2|Participant Flow|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
634630|NCT01079988|P1|Participant Flow|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
634631|NCT01079988|O5|Outcome|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.
Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
634632|NCT01079988|O4|Outcome|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
634633|NCT01079988|O3|Outcome|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
634634|NCT01079988|O2|Outcome|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
634635|NCT01079988|O1|Outcome|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
634636|NCT01079988|O5|Outcome|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.
Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
634637|NCT01079988|O4|Outcome|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
634638|NCT01079988|O3|Outcome|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
634639|NCT01079988|O2|Outcome|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
634640|NCT01079988|O1|Outcome|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
634641|NCT01079988|E5|Reported Event|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.
Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
644917|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
634642|NCT01079988|E4|Reported Event|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
634643|NCT01079988|E3|Reported Event|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
634644|NCT01079988|E2|Reported Event|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
634645|NCT01079988|E1|Reported Event|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
634646|NCT01080118|B3|Baseline|Total|Total of all reporting groups
634647|NCT01080118|B2|Baseline|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
634648|NCT01080118|B1|Baseline|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
634649|NCT01080118|P4|Participant Flow|Video Laryngoscope Patients|Patients who were intubated using the video laryngoscope by interns or medical student.
634650|NCT01080118|P3|Participant Flow|Rigid Laryngoscope Patients|Patients who were intubated using the rigid laryngoscope by the medical student of intern.
634651|NCT01080118|P2|Participant Flow|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
634652|NCT01080118|P1|Participant Flow|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
634653|NCT01080118|O2|Outcome|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
634654|NCT01080118|O1|Outcome|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
634655|NCT01080118|O2|Outcome|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
634657|NCT01080118|E2|Reported Event|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
634658|NCT01080118|E1|Reported Event|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
634659|NCT01080131|B3|Baseline|Total|Total of all reporting groups
634660|NCT01080131|B2|Baseline|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
634661|NCT01080131|B1|Baseline|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
634662|NCT01080131|P2|Participant Flow|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
634663|NCT01080131|P1|Participant Flow|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
634664|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
634665|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
634666|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
634667|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the Ccre study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
634857|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
634668|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
634669|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
634670|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
634671|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
634672|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
634673|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
634674|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
634675|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
635077|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
634676|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
634677|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
634678|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
634679|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
634680|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
634681|NCT01080131|O1|Outcome|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
634682|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
634683|NCT01080131|O1|Outcome|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
634684|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634757|NCT01080209|O4|Outcome|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
634685|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634686|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634687|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634688|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634775|NCT01080248|B1|Baseline|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle."
635078|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
634689|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634690|NCT01080131|O6|Outcome|Triam: After Switch to Canakinumab|Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
634691|NCT01080131|O5|Outcome|Triam: Before Switch to Canakinumab|Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
634692|NCT01080131|O4|Outcome|All Triamcinolone Acetonide|"Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.
Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab."
634693|NCT01080131|O3|Outcome|Canakinumab: After Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
634694|NCT01080131|O2|Outcome|Canakinumab: Before Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
634695|NCT01080131|O1|Outcome|All Canakinumab|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.
In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months."
634696|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634697|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634698|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634758|NCT01080209|O3|Outcome|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
635577|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy
Estradiol: 10mg oral three times daily"
634699|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634700|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634701|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634702|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634703|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634704|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634705|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634706|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634707|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634708|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634709|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634710|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634711|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634759|NCT01080209|O2|Outcome|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
634760|NCT01080209|O1|Outcome|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
634712|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634713|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634714|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634715|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634716|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
634717|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
634718|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634719|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634720|NCT01080131|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
634721|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634722|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634723|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634724|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634725|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634726|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634727|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634761|NCT01080209|O7|Outcome|Sham|Patients who received sham in a previous study.
634762|NCT01080209|O6|Outcome|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
634728|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634729|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634730|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634731|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634732|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
634776|NCT01080248|P1|Participant Flow|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle."
634733|NCT01080131|E6|Reported Event|Triam: After Switch to Canakinumab|Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
634734|NCT01080131|E5|Reported Event|Triam: Before Switch to Canakinumab|Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
634735|NCT01080131|E4|Reported Event|All Triamcinolone Acetonide|"Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.
Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab."
634736|NCT01080131|E3|Reported Event|Canakinumab: After Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
634737|NCT01080131|E2|Reported Event|Canakinumab: Before Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
634738|NCT01080131|E1|Reported Event|All Canakinumab|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.
In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months."
634739|NCT01080209|B8|Baseline|Total|Total of all reporting groups
634740|NCT01080209|B7|Baseline|Sham|Patients who received sham in a previous study.
634741|NCT01080209|B6|Baseline|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
634742|NCT01080209|B5|Baseline|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
634743|NCT01080209|B4|Baseline|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
634744|NCT01080209|B3|Baseline|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
634745|NCT01080209|B2|Baseline|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
634746|NCT01080209|B1|Baseline|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
634747|NCT01080209|P7|Participant Flow|Sham|Patients who received sham in a previous study.
634748|NCT01080209|P6|Participant Flow|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
634749|NCT01080209|P5|Participant Flow|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
634750|NCT01080209|P4|Participant Flow|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
634751|NCT01080209|P3|Participant Flow|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
634752|NCT01080209|P2|Participant Flow|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
634753|NCT01080209|P1|Participant Flow|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
634754|NCT01080209|O7|Outcome|Sham|Patients who received sham in a previous study.
634755|NCT01080209|O6|Outcome|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
634756|NCT01080209|O5|Outcome|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
634763|NCT01080209|O5|Outcome|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
634764|NCT01080209|O4|Outcome|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
634765|NCT01080209|O3|Outcome|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
634766|NCT01080209|O2|Outcome|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
634767|NCT01080209|O1|Outcome|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
634768|NCT01080209|E7|Reported Event|Sham|Patients who received sham in a previous study.
634769|NCT01080209|E6|Reported Event|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
634770|NCT01080209|E5|Reported Event|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
634771|NCT01080209|E4|Reported Event|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
634772|NCT01080209|E3|Reported Event|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
634773|NCT01080209|E2|Reported Event|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
634774|NCT01080209|E1|Reported Event|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
634777|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle."
634778|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle."
634779|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle."
634780|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle."
634781|NCT01080248|E1|Reported Event|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle."
634782|NCT01080261|B1|Baseline|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634783|NCT01080261|P1|Participant Flow|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634784|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634785|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634786|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634787|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634788|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634789|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634790|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634791|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634792|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634793|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634794|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634795|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634796|NCT01080261|E1|Reported Event|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
634797|NCT01080300|B3|Baseline|Total|Total of all reporting groups
634798|NCT01080300|B2|Baseline|Sugar Pill|Placebo 1800 mg
634799|NCT01080300|B1|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
634800|NCT01080300|P2|Participant Flow|Sugar Pill|Placebo 1800 mg
634801|NCT01080300|P1|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
634802|NCT01080300|O2|Outcome|Sugar Pill|Placebo 1800 mg
634803|NCT01080300|O1|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
634804|NCT01080300|O2|Outcome|Sugar Pill|Placebo 1800 mg
634805|NCT01080300|O1|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
634806|NCT01080300|E2|Reported Event|Sugar Pill|Placebo 1800 mg
634807|NCT01080300|E1|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
634808|NCT01080326|B1|Baseline|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.
Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
634809|NCT01080326|P1|Participant Flow|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.
Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
634810|NCT01080326|O1|Outcome|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.
Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
634811|NCT01080326|E1|Reported Event|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.
Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
634813|NCT01080391|B2|Baseline|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
634814|NCT01080391|B1|Baseline|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
634815|NCT01080391|P2|Participant Flow|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
634816|NCT01080391|P1|Participant Flow|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
634817|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
634818|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
634819|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
634820|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
634821|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
634822|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
634854|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
634855|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
634856|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
634823|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
634824|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
634825|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
634826|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
634869|NCT01080768|B2|Baseline|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
634827|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
634828|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
634829|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
634830|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
634831|NCT01080391|E2|Reported Event|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
634832|NCT01080391|E1|Reported Event|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
634833|NCT01080625|B4|Baseline|Total|Total of all reporting groups
634834|NCT01080625|B3|Baseline|Control|10 ml of normal saline is administered at the time of reperfusion
634835|NCT01080625|B2|Baseline|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
634836|NCT01080625|B1|Baseline|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
634837|NCT01080625|P3|Participant Flow|Control|10 ml of normal saline is administered at the time of reperfusion
634838|NCT01080625|P2|Participant Flow|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
634839|NCT01080625|P1|Participant Flow|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
634840|NCT01080625|O3|Outcome|Control|10 ml of normal saline is administered at the time of reperfusion
634841|NCT01080625|O2|Outcome|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
634842|NCT01080625|O1|Outcome|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
634843|NCT01080625|E3|Reported Event|Control|10 ml of normal saline is administered at the time of reperfusion
634844|NCT01080625|E2|Reported Event|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
634845|NCT01080625|E1|Reported Event|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
634846|NCT01080677|B4|Baseline|Total|Total of all reporting groups
634847|NCT01080677|B3|Baseline|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
634848|NCT01080677|B2|Baseline|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
634849|NCT01080677|B1|Baseline|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
634850|NCT01080677|P3|Participant Flow|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
634851|NCT01080677|P2|Participant Flow|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
634852|NCT01080677|P1|Participant Flow|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
634853|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
644918|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
634858|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
634859|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
634860|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
634861|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
634862|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
634863|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
634864|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
634865|NCT01080677|E3|Reported Event|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
634866|NCT01080677|E2|Reported Event|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
634867|NCT01080677|E1|Reported Event|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
634868|NCT01080768|B3|Baseline|Total|Total of all reporting groups
635079|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635080|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
636537|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
634870|NCT01080768|B1|Baseline|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
634871|NCT01080768|P2|Participant Flow|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
634872|NCT01080768|P1|Participant Flow|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
634873|NCT01080768|O2|Outcome|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
634874|NCT01080768|O1|Outcome|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
634875|NCT01080768|E2|Reported Event|Amlodipine and Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patient up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
634876|NCT01080768|E1|Reported Event|Aliskiren/Amlodipine and Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patient up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
634877|NCT01080794|B5|Baseline|Total|Total of all reporting groups
634878|NCT01080794|B4|Baseline|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634939|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634879|NCT01080794|B3|Baseline|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634880|NCT01080794|B2|Baseline|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
644038|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
634881|NCT01080794|B1|Baseline|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634882|NCT01080794|P4|Participant Flow|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634883|NCT01080794|P3|Participant Flow|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634884|NCT01080794|P2|Participant Flow|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634885|NCT01080794|P1|Participant Flow|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634996|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
644919|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
634886|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634887|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634888|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634889|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634890|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634891|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634892|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634997|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635578|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy
Estradiol: 10mg oral three times daily"
634893|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634894|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634895|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634896|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634897|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634898|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634899|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634998|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635065|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
634900|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634941|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
635081|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635082|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
634901|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634902|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634903|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634904|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634905|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634906|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634999|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635164|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
634907|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634908|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634909|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634910|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634911|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634912|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634913|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
635000|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635579|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy
Estradiol: 10mg oral three times daily"
634914|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634915|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634916|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634917|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634918|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634919|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634920|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
635001|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635580|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy
Estradiol: 10mg oral three times daily"
634921|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634922|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634923|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634924|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634925|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634926|NCT01080794|E4|Reported Event|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634927|NCT01080794|E3|Reported Event|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
635015|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635165|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
634928|NCT01080794|E2|Reported Event|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634929|NCT01080794|E1|Reported Event|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).
Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
634930|NCT01080807|B3|Baseline|Total|Total of all reporting groups
634931|NCT01080807|B2|Baseline|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634932|NCT01080807|B1|Baseline|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634933|NCT01080807|P2|Participant Flow|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634934|NCT01080807|P1|Participant Flow|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634935|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634936|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634937|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634938|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
635055|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
634940|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
635074|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
635075|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635076|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
634942|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634943|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634944|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634945|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634946|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634947|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634948|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634949|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634950|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
635056|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635057|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635058|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
634951|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634952|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634953|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634954|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634955|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634956|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634957|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634958|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634959|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634960|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634961|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
635059|NCT01081132|E2|Reported Event|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635060|NCT01081132|E1|Reported Event|PLACEBO|Orally administered a once-daily dose
644920|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
634962|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634963|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634964|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634965|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634966|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634967|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634968|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634969|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634970|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634971|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634972|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
635061|NCT01081145|B1|Baseline|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635062|NCT01081145|P2|Participant Flow|Placebo|Administered as a once-daily oral dose
636815|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
634973|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634974|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634975|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634976|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634977|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634978|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634979|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634980|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634981|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634982|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634983|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
635063|NCT01081145|P1|Participant Flow|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635064|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
634984|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634985|NCT01080807|E2|Reported Event|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634986|NCT01080807|E1|Reported Event|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
634987|NCT01081041|B4|Baseline|Total|Total of all reporting groups
634988|NCT01081041|B3|Baseline|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
634989|NCT01081041|B2|Baseline|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
634990|NCT01081041|B1|Baseline|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
634991|NCT01081041|P3|Participant Flow|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
634992|NCT01081041|P2|Participant Flow|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
634993|NCT01081041|P1|Participant Flow|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):
United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
634994|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
634995|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
644921|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
635002|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):
United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
635003|NCT01081041|O1|Outcome|All Participants (Cetuximab)|"United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
OR
Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly."
635316|NCT01082575|B1|Baseline|Major Surgery|Post Operative patients
635004|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635005|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635006|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):
United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
635007|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635008|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635009|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):
United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
635010|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635011|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635012|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):
United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
635013|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI),|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635014|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635016|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
635017|NCT01081041|E3|Reported Event|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):
Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
644039|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
635018|NCT01081041|E2|Reported Event|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
635019|NCT01081041|E1|Reported Event|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):
US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
635020|NCT01081132|B3|Baseline|Total|Total of all reporting groups
635021|NCT01081132|B2|Baseline|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635022|NCT01081132|B1|Baseline|PLACEBO|Orally administered a once-daily dose
635023|NCT01081132|P2|Participant Flow|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635024|NCT01081132|P1|Participant Flow|PLACEBO|Orally administered a once-daily dose
635025|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635026|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635027|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635028|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635029|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635030|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635031|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635032|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635033|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635034|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635035|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635036|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635037|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635038|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635039|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635040|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635041|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635042|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635043|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635044|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635045|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635046|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635047|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635048|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635049|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635050|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635051|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635052|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635053|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
635054|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
635166|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
635066|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635067|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635068|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635069|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635070|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635071|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635072|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
635073|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635083|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635084|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
635085|NCT01081145|E3|Reported Event|Guanfacine Hydrochloride (Randomized-Withdrawal Phase)|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635086|NCT01081145|E2|Reported Event|Placebo (Randomized-Withdrawal Phase)|Administered as a once-daily oral dose
635087|NCT01081145|E1|Reported Event|Guanfacine Hydrochloride (Open-Label Phase)|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
635088|NCT01081249|B1|Baseline|Active Drug|"placebo
intranasal oxytocin: single dose of 40 IU intranasal oxytocin or similar volume of placebo
placebo: single dose of 40 IU intranasal oxytocin or similar volume of placebo"
635089|NCT01081249|P2|Participant Flow|Placebo Then Oxytocin|Participants received a single dose of intranasal placebo prior to the first psychotherapy session; prior to the second psychotherapy session the participants received a single dose of 40 IU intranasal oxytocin.
635090|NCT01081249|P1|Participant Flow|Oxytocin Then Placebo|Participants received a single dose of 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a similar dose of intranasal placebo.
635091|NCT01081249|O2|Outcome|Active Drug|A dose of 40 IU intranasal oxytocin was administered prior to the psychotherapy session.
635092|NCT01081249|O1|Outcome|Placebo|A dose of intranasal placebo was administered prior to the psychotherapy session.
635093|NCT01081249|E2|Reported Event|Oxytocin Then Placebo|Participants received 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a comparable dose of intranasal placebo spray.
635094|NCT01081249|E1|Reported Event|Placebo Then Oxytocin|Participants received intranasal placebo spray prior to the first psychotherapy session; prior to the second psychotherapy session they received 40 IU intranasal oxytocin.
635095|NCT01081301|B1|Baseline|Living With Hope Program|"The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
635096|NCT01081301|P1|Participant Flow|Living With Hope Program|"Receive Living with Hope Program
Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
635097|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
635098|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
635099|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
635100|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
635101|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
635102|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program
Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
635103|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
635104|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
635105|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
635106|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
635107|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
635167|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
635168|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
635108|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program
Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
635109|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
635110|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
635111|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
635112|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
635113|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
635114|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program
Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
635115|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|"12 months Receive Living with Hope Program
Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
644040|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
635116|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|"6 months Receive Living with Hope Program
Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
635117|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|"3 months Receive Living with Hope Program
Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
635118|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|"Day 14 Receive Living with Hope Program
Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
635119|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|"Day 7 Receive Living with Hope Program
Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
635120|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|Baseline Measure
635121|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
635122|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
635123|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
635124|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
635125|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
635126|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|
635127|NCT01081301|E6|Reported Event|Living With Hope Program [12 Months]|
635128|NCT01081301|E5|Reported Event|Living With Hope Program [6 Months]|
635129|NCT01081301|E4|Reported Event|Living With Hope Program [3 Months]|
635130|NCT01081301|E3|Reported Event|Living With Hope Program [Day 14]|
635131|NCT01081301|E2|Reported Event|Living With Hope Program [Day 7]|
635132|NCT01081301|E1|Reported Event|Living With Hope Program [Baseline]|
635133|NCT01081626|B3|Baseline|Total|Total of all reporting groups
635134|NCT01081626|B2|Baseline|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635135|NCT01081626|B1|Baseline|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635136|NCT01081626|P2|Participant Flow|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635137|NCT01081626|P1|Participant Flow|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635138|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635139|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635140|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635141|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635142|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635143|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635144|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635145|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635146|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635147|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635148|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635149|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635150|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635151|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635152|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635153|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635154|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635155|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635156|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635157|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635158|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635159|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635160|NCT01081626|E2|Reported Event|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635161|NCT01081626|E1|Reported Event|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
635162|NCT01081665|B1|Baseline|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
635163|NCT01081665|P1|Participant Flow|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
635169|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
635170|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
635171|NCT01081665|E1|Reported Event|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
635172|NCT01081769|B3|Baseline|Total|Total of all reporting groups
635173|NCT01081769|B2|Baseline|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
635174|NCT01081769|B1|Baseline|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
635175|NCT01081769|P2|Participant Flow|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
635176|NCT01081769|P1|Participant Flow|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
635177|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635178|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635179|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635317|NCT01082575|P1|Participant Flow|Major Surgery|Post Operative patients
635180|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635181|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635182|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635183|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635184|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635185|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635186|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635187|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635188|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635189|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635190|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635191|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635192|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635193|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635194|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635195|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635196|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635197|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635198|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635199|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635200|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635201|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635202|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635203|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635204|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
636816|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
635205|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
635206|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
635207|NCT01081769|E2|Reported Event|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
635208|NCT01081769|E1|Reported Event|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
635209|NCT01081795|B4|Baseline|Total|Total of all reporting groups
635210|NCT01081795|B3|Baseline|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635211|NCT01081795|B2|Baseline|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635318|NCT01082575|O1|Outcome|General Care Floor|Observational General Care Floor Group
635212|NCT01081795|B1|Baseline|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635213|NCT01081795|P3|Participant Flow|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635214|NCT01081795|P2|Participant Flow|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635215|NCT01081795|P1|Participant Flow|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635216|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635217|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635218|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635219|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635220|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635221|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635222|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635260|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
635223|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635224|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635225|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635226|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635319|NCT01082575|O1|Outcome|General Care Floor|Observational General Care Floor Group
635227|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635228|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635229|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635230|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635231|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635232|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635233|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635234|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635235|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635236|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635237|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635261|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
635262|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
635238|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635239|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635240|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635241|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635242|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635243|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635244|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635245|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635246|NCT01081795|E3|Reported Event|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635247|NCT01081795|E2|Reported Event|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635248|NCT01081795|E1|Reported Event|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
635249|NCT01081834|B6|Baseline|Total|Total of all reporting groups
635250|NCT01081834|B5|Baseline|High Glycemic Substudy: Canagliflozin 300 mg|In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks.
635251|NCT01081834|B4|Baseline|High Glycemic Substudy: Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
635252|NCT01081834|B3|Baseline|Main Study: Canagliflozin 300 mg|In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.
635253|NCT01081834|B2|Baseline|Main Study: Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
635254|NCT01081834|B1|Baseline|Main Study: Placebo/Sitagliptin|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
635255|NCT01081834|P5|Participant Flow|High Glycemic Substudy: Canagliflozin 300 mg|In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.
635256|NCT01081834|P4|Participant Flow|High Glycemic Substudy: Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.
635257|NCT01081834|P3|Participant Flow|Main Study: Canagliflozin 300 mg|In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.
635258|NCT01081834|P2|Participant Flow|Main Study: Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
635259|NCT01081834|P1|Participant Flow|Main Study: Placebo/Sitagliptin|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
635263|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
635264|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
635265|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
635266|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
635267|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
635268|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
635269|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
635270|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
635271|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
635272|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
635273|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
635274|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
635275|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
635276|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
635277|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
635278|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
635279|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
635280|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
635281|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
635282|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
635283|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
635284|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
635285|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
635286|NCT01081834|O1|Outcome|Placebo|In the Main study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
635287|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
635288|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
635289|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
635290|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
635291|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
635292|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
635293|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
635294|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
635295|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
635296|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
635297|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
635298|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
635299|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
635300|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
635301|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
635302|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
635303|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
635304|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
635305|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
635306|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
635307|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
635349|NCT01082614|E2|Reported Event|Goal Directed Therapy|
635308|NCT01081834|E8|Reported Event|High Glycemic Substudy (Baseline to Week 26): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.
635309|NCT01081834|E7|Reported Event|High Glycemic Substudy (Baseline to Week 26): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.
635310|NCT01081834|E6|Reported Event|Main Study (Baseline to Week 52): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.
635311|NCT01081834|E5|Reported Event|Main Study (Baseline to Week 52): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.
635312|NCT01081834|E4|Reported Event|Main Study (Baseline to Week 52): Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 52.
635313|NCT01081834|E3|Reported Event|Main Study (Baseline to Week 26): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.
635314|NCT01081834|E2|Reported Event|Main Study (Baseline to Week 26): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.
635315|NCT01081834|E1|Reported Event|Main Study (Baseline to Week 26): Placebo|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 26.
635322|NCT01082588|B2|Baseline|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635323|NCT01082588|B1|Baseline|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635324|NCT01082588|P2|Participant Flow|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635325|NCT01082588|P1|Participant Flow|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635326|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635327|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635328|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635329|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635330|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635331|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635332|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635333|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635334|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635335|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635336|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635337|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635338|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635339|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
635340|NCT01082588|E2|Reported Event|Placebo|"pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Placebo: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks"
635341|NCT01082588|E1|Reported Event|Pravastatin|"pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Pravastatin: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks"
635342|NCT01082614|B3|Baseline|Total|Total of all reporting groups
635343|NCT01082614|B2|Baseline|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis
Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
635344|NCT01082614|B1|Baseline|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
635345|NCT01082614|P2|Participant Flow|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis
Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
635346|NCT01082614|P1|Participant Flow|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
635347|NCT01082614|O2|Outcome|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis
Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
635348|NCT01082614|O1|Outcome|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
635352|NCT01082640|B3|Baseline|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
635353|NCT01082640|B2|Baseline|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
635354|NCT01082640|B1|Baseline|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
635355|NCT01082640|P3|Participant Flow|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
635356|NCT01082640|P2|Participant Flow|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
635357|NCT01082640|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
635358|NCT01082640|O3|Outcome|Febuxostat 80 mg QD|Participants with serum urate levels ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD from the Month 1 visit through Month 12.
635359|NCT01082640|O2|Outcome|Febuxostat 40 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit.
635360|NCT01082640|O1|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
635361|NCT01082640|O3|Outcome|Febuxostat 80 mg QD|Participants with serum urate levels ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD from the Month 1 visit through Month 12.
635362|NCT01082640|O2|Outcome|Febuxostat 40 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit.
635363|NCT01082640|O1|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
635364|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
635365|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
635366|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
635367|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
635368|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
635369|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
635370|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
635371|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
635372|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
635373|NCT01082640|E3|Reported Event|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
635374|NCT01082640|E2|Reported Event|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
635375|NCT01082640|E1|Reported Event|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
635376|NCT01082874|B5|Baseline|Total|Total of all reporting groups
635377|NCT01082874|B4|Baseline|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635378|NCT01082874|B3|Baseline|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635379|NCT01082874|B2|Baseline|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635380|NCT01082874|B1|Baseline|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635381|NCT01082874|P4|Participant Flow|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
636817|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
635382|NCT01082874|P3|Participant Flow|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635383|NCT01082874|P2|Participant Flow|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635384|NCT01082874|P1|Participant Flow|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635385|NCT01082874|O4|Outcome|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635386|NCT01082874|O3|Outcome|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635452|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
635387|NCT01082874|O2|Outcome|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635388|NCT01082874|O1|Outcome|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635389|NCT01082874|E4|Reported Event|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635390|NCT01082874|E3|Reported Event|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635391|NCT01082874|E2|Reported Event|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635392|NCT01082874|E1|Reported Event|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
635393|NCT01082939|B1|Baseline|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
635394|NCT01082939|P1|Participant Flow|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
635395|NCT01082939|O1|Outcome|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
635396|NCT01082939|E1|Reported Event|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
635397|NCT01082952|B3|Baseline|Total|Total of all reporting groups
635398|NCT01082952|B2|Baseline|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
635399|NCT01082952|B1|Baseline|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
635400|NCT01082952|P2|Participant Flow|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
635401|NCT01082952|P1|Participant Flow|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
635402|NCT01082952|O2|Outcome|Non Asthmatic Patients|Non asthmatic patients with high Eosinophil count (>3%)
635403|NCT01082952|O1|Outcome|Asthmatic Patients|Mild asthmatic patients with high eosinophil count (>5%)
635404|NCT01082952|O2|Outcome|Non Asthmatic Patients|Non asthmatic patients with high Eosinophil count (>3%)
635405|NCT01082952|O1|Outcome|Asthmatic Patients|Mild asthmatic patients with high eosinophil count (>5%)
635406|NCT01082952|E2|Reported Event|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
635407|NCT01082952|E1|Reported Event|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
635408|NCT01082965|B3|Baseline|Total|Total of all reporting groups
635409|NCT01082965|B2|Baseline|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
635410|NCT01082965|B1|Baseline|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
635411|NCT01082965|P2|Participant Flow|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
635412|NCT01082965|P1|Participant Flow|Donepezil|Donepezil 5 milligram (mg) tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
635413|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
635414|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
635415|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
635416|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
635453|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
635417|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
635418|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
635419|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
635420|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
635421|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
635422|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
635423|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
635424|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
635425|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
635426|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
635427|NCT01082965|E2|Reported Event|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
635428|NCT01082965|E1|Reported Event|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
635429|NCT01083121|B1|Baseline|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
635430|NCT01083121|P1|Participant Flow|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
635431|NCT01083121|O4|Outcome|Crohn's Disease|Participants with severely active Crohn's disease who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
635432|NCT01083121|O3|Outcome|Ankylosing Spondylitis|Participants with severe active ankylosing spondylitis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
635433|NCT01083121|O2|Outcome|Psoriatic Arthritis|Participants with active and progressive psoriatic arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
635434|NCT01083121|O1|Outcome|Rheumatoid Arthritis|Participants with moderately to severely active rheumatoid arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
635435|NCT01083121|O1|Outcome|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
635436|NCT01083121|E1|Reported Event|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
635437|NCT01083160|B1|Baseline|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
635438|NCT01083160|P1|Participant Flow|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
635439|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
635440|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
635441|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
635581|NCT01083641|E1|Reported Event|Estrogen Therapy|"Estrogen therapy
Estradiol: 10mg oral three times daily"
635442|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
635443|NCT01083160|E1|Reported Event|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
635444|NCT01083173|B1|Baseline|Overall Study|The main surveillance safety population included all participants who received at least one dose of Kaletra. The long-term surveillance safety population included participants who received Kaletra for more than 24 weeks.
635445|NCT01083173|P2|Participant Flow|Long-term Surveillance|The safety population included all participants who received Kaletra for more than 24 weeks, and the effectiveness population included all participants who received Kaletra treatment for at least 48 weeks.
635446|NCT01083173|P1|Participant Flow|Main Surveillance|The safety population included all participants who received at least one dose of Kaletra, and the effectiveness population included all participants who received Kaletra treatment for at least 24 weeks.
635447|NCT01083173|O1|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
635448|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
635449|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
635450|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
635451|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
635454|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
635455|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
635456|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
635457|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
635458|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
635459|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
635460|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
635461|NCT01083173|E2|Reported Event|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
635462|NCT01083173|E1|Reported Event|Main Surveillance|All participants who received at least one dose of Kaletra
635463|NCT01083186|B1|Baseline|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635464|NCT01083186|P1|Participant Flow|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635465|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635466|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635467|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635468|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635469|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635470|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635471|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635472|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635473|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635474|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635475|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635582|NCT01083654|B3|Baseline|Total|Total of all reporting groups
636818|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
635476|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635477|NCT01083186|O4|Outcome|CKD Stage 5|Participants with chronic kidney disease stage 5 (eGFR <15 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635478|NCT01083186|O3|Outcome|CKD Stage 4|Participants with chronic kidney disease stage 4 (eGFR 15-29 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635479|NCT01083186|O2|Outcome|CKD Stage 3|Participants with chronic kidney disease stage 3 (eGFR 30-59 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635480|NCT01083186|O1|Outcome|CKD Stage 2|Participants with chronic kidney disease stage 2 (eGFR 60-89 mL/min/1.73m^2) with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635481|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635482|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635483|NCT01083186|O5|Outcome|"+++ Albuminuria at Month 12"|"The value +++ is taken directly from the dipstick measurements, and represents the highest albuminuria."
635484|NCT01083186|O4|Outcome|"++ Albuminuria at Month 12"|"The value ++ is taken directly from the dipstick measurements, and represents the value second to highest albuminuria."
635485|NCT01083186|O3|Outcome|"+ Albuminuria at Month 12"|"The value + is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria."
635486|NCT01083186|O2|Outcome|Trace Albuminuria at Month 12|"The value Trace is taken directly from the dipstick measurements, and represents a reading of trace albuminuria."
635487|NCT01083186|O1|Outcome|No Albuminuria at Month 12|"The value - is taken directly from the dipstick measurements, and represents a reading of no albuminuria."
635488|NCT01083186|O5|Outcome|"+++ Albuminuria at Month 6"|"The value +++ is taken directly from the dipstick measurements, and represents the highest albuminuria."
635489|NCT01083186|O4|Outcome|"++ Albuminuria at Month 6"|"The value ++ is taken directly from the dipstick measurements, and represents the value second to highest albuminuria."
635490|NCT01083186|O3|Outcome|"+ Albuminuria at Month 6"|"The value + is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria."
635491|NCT01083186|O2|Outcome|Trace Albuminuria at Month 6|"The value Trace is taken directly from the dipstick measurements, and represents a reading of trace albuminuria."
635492|NCT01083186|O1|Outcome|No Albuminuria at Month 6|"The value - is taken directly from the dipstick measurements, and represents a reading of no albuminuria."
635493|NCT01083186|O2|Outcome|Participants Outside of the Phosphorus Normal Range|Normal serum phosphorus range was 2.7-4.6 mg/dL.
635494|NCT01083186|O1|Outcome|Participants Within the Phosphorus Normal Range|Normal serum phosphorus range was 2.7-4.6 mg/dL.
635495|NCT01083186|O2|Outcome|Participants Outside of the Normal Calcium Range|Normal serum calcium range was 8.4-10.2 mg/dL.
635496|NCT01083186|O1|Outcome|Participants Within the Normal Calcium Range|Normal serum calcium range was 8.4-10.2 mg/dL.
635497|NCT01083186|O2|Outcome|Participants Out of the iPTH Target Range|Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.
635498|NCT01083186|O1|Outcome|Participants Within the iPTH Target Range|Number of participants with iPTH levels within the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.
635499|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635500|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635501|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635502|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635503|NCT01083186|E1|Reported Event|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
635504|NCT01083199|B1|Baseline|AMS CONTINUUM™ Device|
635505|NCT01083199|P1|Participant Flow|AMS CONTINUUM™ Device|
635506|NCT01083199|O1|Outcome|AMS CONTINUUM™ Device|
635507|NCT01083199|O1|Outcome|Continuum Device|
635508|NCT01083199|E1|Reported Event|AMS CONTINUUM™ Device|
635509|NCT01083316|B1|Baseline|Bortezomib and Dexamethasone|"Induction:
Bortezomib (Velcade) 1.3 mg/m2/dose intravenous (IV) Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1
Bortezomib (Velcade) and Dexamethasone: Induction:
Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days
Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4
Melphalan 70-100 mg/m2/day IV on days -2 and -1"
635510|NCT01083316|P1|Participant Flow|Bortezomib and Dexamethasone|"Induction:
Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1
Bortezomib (Velcade) and Dexamethasone: Induction:
Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days
Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4
Melphalan 70-100 mg/m2/day IV on days -2 and -1"
635511|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:
Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1
Bortezomib (Velcade) and Dexamethasone: Induction:
Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days
Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4
Melphalan 70-100 mg/m2/day IV on days -2 and -1"
635512|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:
Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1
Bortezomib (Velcade) and Dexamethasone: Induction:
Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days
Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4
Melphalan 70-100 mg/m2/day IV on days -2 and -1"
635548|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635549|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635513|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:
Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1
Bortezomib (Velcade) and Dexamethasone: Induction:
Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days
Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4
Melphalan 70-100 mg/m2/day IV on days -2 and -1"
635514|NCT01083316|E1|Reported Event|Bortezomib and Dexamethasone|"Induction:
Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1
Bortezomib (Velcade) and Dexamethasone: Induction:
Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days
Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days
Conditioning:
Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4
Melphalan 70-100 mg/m2/day IV on days -2 and -1"
635515|NCT01083472|B3|Baseline|Total|Total of all reporting groups
635516|NCT01083472|B2|Baseline|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
635517|NCT01083472|B1|Baseline|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
635518|NCT01083472|P2|Participant Flow|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
635519|NCT01083472|P1|Participant Flow|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
635520|NCT01083472|O2|Outcome|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
635521|NCT01083472|O1|Outcome|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
635522|NCT01083472|E2|Reported Event|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
635523|NCT01083472|E1|Reported Event|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
635524|NCT01083485|B3|Baseline|Total|Total of all reporting groups
635525|NCT01083485|B2|Baseline|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
635526|NCT01083485|B1|Baseline|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
635527|NCT01083485|P2|Participant Flow|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
635528|NCT01083485|P1|Participant Flow|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
635529|NCT01083485|O2|Outcome|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
635530|NCT01083485|O1|Outcome|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
635531|NCT01083485|O2|Outcome|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses). Mean baseline pain score = 3.1
635532|NCT01083485|O1|Outcome|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses). Mean baseline pain score = 3.4
635533|NCT01083485|E2|Reported Event|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
635534|NCT01083485|E1|Reported Event|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
635535|NCT01083576|B3|Baseline|Total|Total of all reporting groups
635536|NCT01083576|B2|Baseline|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635537|NCT01083576|B1|Baseline|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635538|NCT01083576|P2|Participant Flow|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635539|NCT01083576|P1|Participant Flow|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
635540|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635541|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
635542|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635543|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
635544|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635545|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635546|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635547|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
636079|NCT01084603|O1|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
635550|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635551|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635552|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635553|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635554|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635555|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635556|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635557|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
635558|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635559|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635560|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635561|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635562|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635563|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635564|NCT01083576|E2|Reported Event|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635565|NCT01083576|E1|Reported Event|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
635566|NCT01083602|B1|Baseline|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
635567|NCT01083602|P1|Participant Flow|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
635568|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
635569|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
635570|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
635571|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
635572|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
635573|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
635574|NCT01083602|E1|Reported Event|PAN + BTZ + Dex|PAN + BTZ + Dex
635575|NCT01083641|B1|Baseline|Estrogen Therapy|"Estrogen therapy
Estradiol: 10mg oral three times daily"
635576|NCT01083641|P1|Participant Flow|Estrogen Therapy|"Estrogen therapy
Estradiol: 10mg oral three times daily"
635583|NCT01083654|B2|Baseline|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).
The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol of long life)"
635584|NCT01083654|B1|Baseline|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).
ST Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by an enrolled member of the Menominee Tribe but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling."
635596|NCT01083680|B1|Baseline|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
636080|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
635585|NCT01083654|P2|Participant Flow|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).
Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
635586|NCT01083654|P1|Participant Flow|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).
Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
635587|NCT01083654|O2|Outcome|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).
Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
635588|NCT01083654|O1|Outcome|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).
Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
635589|NCT01083654|E2|Reported Event|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).
Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
635625|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635626|NCT01083693|O1|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
635627|NCT01083693|O3|Outcome|Total|
635590|NCT01083654|E1|Reported Event|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).
Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
635591|NCT01083667|B1|Baseline|Pyrimethamine|"Open label. Only one arm will receive the intervention.
Pyrimethamine: Open Label, dose escalating,"
635592|NCT01083667|P1|Participant Flow|Pyrimethamine|"Open label. Only one arm will receive the intervention.
Pyrimethamine: Open Label, dose escalating,"
635593|NCT01083667|O1|Outcome|Pyrimethamine|"Open label. Only one arm will receive the intervention.
Pyrimethamine: Open Label, dose escalating,"
635594|NCT01083667|O1|Outcome|Pyrimethamine|"Open label. Only one arm will receive the intervention.
Pyrimethamine: Open Label, dose escalating,"
635595|NCT01083667|E1|Reported Event|Pyrimethamine|"Open label. Only one arm will receive the intervention.
Pyrimethamine: Open Label, dose escalating,"
636081|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
635597|NCT01083680|P1|Participant Flow|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
635598|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
635599|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
635600|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
635601|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
635602|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
635603|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
635604|NCT01083680|E1|Reported Event|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
635605|NCT01083693|B4|Baseline|Total|Total of all reporting groups
635606|NCT01083693|B3|Baseline|Ankylosing Spondylitis (AS)|Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
635607|NCT01083693|B2|Baseline|Psoriasis Arthritis (PsA)|Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635608|NCT01083693|B1|Baseline|Rheumatoid Arthritis (RA)|Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635609|NCT01083693|P3|Participant Flow|Ankylosing Spondylitis (AS)|Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
635610|NCT01083693|P2|Participant Flow|Psoriasis Arthritis (PsA)|Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635611|NCT01083693|P1|Participant Flow|Rheumatoid Arthritis (RA)|Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635612|NCT01083693|O4|Outcome|Total|
635613|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
635614|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635615|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635616|NCT01083693|O4|Outcome|Total|
635617|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
635618|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635619|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635620|NCT01083693|O3|Outcome|Total|
635621|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635622|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635623|NCT01083693|O3|Outcome|Total|
635624|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635763|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
635628|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635629|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635630|NCT01083693|O4|Outcome|Total|
635631|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
635632|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635633|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635634|NCT01083693|O4|Outcome|Total|
635635|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
635636|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635987|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
635637|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635638|NCT01083693|O3|Outcome|Total|
635639|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635640|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635641|NCT01083693|E4|Reported Event|Total|
635642|NCT01083693|E3|Reported Event|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
635643|NCT01083693|E2|Reported Event|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635644|NCT01083693|E1|Reported Event|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
635645|NCT01083706|B1|Baseline|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
laboratory biomarker analysis: Correlative studies"
635646|NCT01083706|P1|Participant Flow|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
laboratory biomarker analysis: Correlative studies"
635647|NCT01083706|O1|Outcome|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
laboratory biomarker analysis: Correlative studies"
635648|NCT01083706|O1|Outcome|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
laboratory biomarker analysis: Correlative studies"
635649|NCT01083706|O1|Outcome|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
laboratory biomarker analysis: Correlative studies"
635650|NCT01083706|E1|Reported Event|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
laboratory biomarker analysis: Correlative studies"
635651|NCT01083732|B4|Baseline|Total|Total of all reporting groups
635652|NCT01083732|B3|Baseline|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635653|NCT01083732|B2|Baseline|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635654|NCT01083732|B1|Baseline|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635655|NCT01083732|P3|Participant Flow|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635656|NCT01083732|P2|Participant Flow|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635657|NCT01083732|P1|Participant Flow|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years):|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635658|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635659|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635660|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635661|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635662|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635663|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635664|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635665|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635666|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635667|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635668|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635669|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635670|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635671|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635672|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635673|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635674|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635675|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635676|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635677|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635764|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
635765|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
635678|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635679|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635680|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635681|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635682|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation).
635683|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635684|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635685|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635686|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635687|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635688|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635689|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635690|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635691|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635692|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635693|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635694|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635695|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635696|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635697|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635722|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635698|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635699|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635700|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635701|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635728|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635702|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635703|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635704|NCT01083732|E3|Reported Event|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635705|NCT01083732|E2|Reported Event|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635706|NCT01083732|E1|Reported Event|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
635707|NCT01083758|B1|Baseline|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635708|NCT01083758|P1|Participant Flow|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635709|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635710|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635711|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635712|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635713|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635714|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635715|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635716|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635717|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635718|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635719|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635720|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635721|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635844|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635723|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635724|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635725|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635726|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635727|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
636070|NCT01084551|E2|Reported Event|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
635729|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635730|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635731|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635732|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635733|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635734|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635735|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635736|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635737|NCT01083758|E1|Reported Event|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
635738|NCT01083771|B1|Baseline|Olive Oil|"At least 3 tablespoons of olive oil each day
Olive Oil: Minimum of 3 tablespoon of olive oil per day"
635739|NCT01083771|P1|Participant Flow|Olive Oil|"At least 3 tablespoons of olive oil each day
Olive Oil: Minimum of 3 tablespoon of olive oil per day"
635740|NCT01083771|O1|Outcome|Olive Oil|"At least 3 tablespoons of olive oil each day
Olive Oil: Minimum of 3 tablespoon of olive oil per day"
635741|NCT01083771|O1|Outcome|Olive Oil|"At least 3 tablespoons of olive oil each day
Olive Oil: Minimum of 3 tablespoon of olive oil per day"
635742|NCT01083771|E1|Reported Event|Olive Oil|"At least 3 tablespoons of olive oil each day
Olive Oil: Minimum of 3 tablespoon of olive oil per day"
635743|NCT01083810|B4|Baseline|Total|Total of all reporting groups
635744|NCT01083810|B3|Baseline|Non-B|Participants infected with non-B subtypes of HIV-1.
635745|NCT01083810|B2|Baseline|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
635746|NCT01083810|B1|Baseline|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
635747|NCT01083810|P3|Participant Flow|Non-B|Participants infected with non-B subtypes of HIV-1.
635748|NCT01083810|P2|Participant Flow|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
635749|NCT01083810|P1|Participant Flow|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
635750|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
635751|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
635752|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
635753|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
635754|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
635755|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
635756|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
635757|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
635758|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
635759|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
635760|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
635761|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
635762|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
644922|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
635766|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
635767|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
635768|NCT01083810|E1|Reported Event|HIV-infected Patients|Participants with HIV-1 infection, pooled from 3 studies in different populations conducted in parallel: KAL1RO (therapy-naive, NCT01083810, n=137), KAL2RO /KAL5RO (pre-treated, NCT01083836, n=92), and KAL6RO (non-B subtype, NCT01081470, n=55).
635769|NCT01083849|B3|Baseline|Total|Total of all reporting groups
635770|NCT01083849|B2|Baseline|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635771|NCT01083849|B1|Baseline|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635772|NCT01083849|P2|Participant Flow|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635773|NCT01083849|P1|Participant Flow|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635774|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635775|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635776|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635777|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635778|NCT01083849|O1|Outcome|Paricalcitol|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635779|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635780|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635781|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635782|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635783|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635784|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635785|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635786|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635787|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
635788|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
635789|NCT01083849|O1|Outcome|Paricalcitol|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635790|NCT01083849|E2|Reported Event|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635845|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
635791|NCT01083849|E1|Reported Event|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
635792|NCT01083901|B4|Baseline|Total|Total of all reporting groups
635793|NCT01083901|B3|Baseline|Placebo and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks.
635794|NCT01083901|B2|Baseline|Ibuprofen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
635795|NCT01083901|B1|Baseline|Acetaminophen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
635796|NCT01083901|P3|Participant Flow|Placebo and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks.
636071|NCT01084551|E1|Reported Event|Placebo|0 mg/day for 13 weeks
635797|NCT01083901|P2|Participant Flow|Ibuprofen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
635798|NCT01083901|P1|Participant Flow|Acetaminophen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
635799|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
635800|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
635801|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
635802|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
635803|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
635804|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
635805|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
635806|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
635807|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
635808|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
635809|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
635810|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
635811|NCT01083901|E3|Reported Event|Placebo and Resistance Exercise Training|
635812|NCT01083901|E2|Reported Event|Ibuprofen and Resistance Exercise Traininig|
635813|NCT01083901|E1|Reported Event|Acetaminophen and Resistance Exercise Training|
635814|NCT01083979|B1|Baseline|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
635815|NCT01083979|P1|Participant Flow|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
635816|NCT01083979|O1|Outcome|Liposomes|Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
635817|NCT01083979|O1|Outcome|Liposomes|Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
635818|NCT01083979|E1|Reported Event|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
635819|NCT01084005|B3|Baseline|Total|Total of all reporting groups
635820|NCT01084005|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635821|NCT01084005|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
635822|NCT01084005|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635823|NCT01084005|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
635824|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635825|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
635826|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635827|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
635828|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635829|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
635830|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635831|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
635832|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635833|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
635834|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635835|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
635836|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635837|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
635838|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635839|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
635840|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635841|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
635842|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635843|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
644923|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
635846|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635847|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
635848|NCT01084005|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
635849|NCT01084005|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
635850|NCT01084083|B1|Baseline|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
635902|NCT01084239|B2|Baseline|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
636072|NCT01084603|B1|Baseline|Overall Study|Full Safety Set
635851|NCT01084083|P1|Participant Flow|Overall|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
635852|NCT01084083|O1|Outcome|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
635853|NCT01084083|O1|Outcome|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
635854|NCT01084083|O1|Outcome|Primary Study Population|The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.
635855|NCT01084083|E1|Reported Event|All Treated Patients|"Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
Adverse events data were reported for all patients received at least one dose of protocol therapy."
635856|NCT01084135|B5|Baseline|Total|Total of all reporting groups
635857|NCT01084135|B4|Baseline|12 Week Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
635858|NCT01084135|B3|Baseline|12 Week Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.
635859|NCT01084135|B2|Baseline|20 Week Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
635860|NCT01084135|B1|Baseline|20 Week Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
635861|NCT01084135|P2|Participant Flow|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
635862|NCT01084135|P1|Participant Flow|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
635863|NCT01084135|O2|Outcome|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
635895|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally"
635896|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually"
644924|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
635864|NCT01084135|O1|Outcome|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
635865|NCT01084135|O2|Outcome|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
635866|NCT01084135|O1|Outcome|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
635867|NCT01084135|E4|Reported Event|12 Week: Liquid Placebo|Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
635868|NCT01084135|E3|Reported Event|12 Week: Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.
635869|NCT01084135|E2|Reported Event|20 Week: Liquid Placebo|Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
635870|NCT01084135|E1|Reported Event|20 Week: Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
635871|NCT01084148|B3|Baseline|Total|Total of all reporting groups
635872|NCT01084148|B2|Baseline|V0034 CR 01B Vehicle|"cream
V0034CR01B vehicle"
635873|NCT01084148|B1|Baseline|V0034CR01B|"cream
V0034CR01B"
635874|NCT01084148|P2|Participant Flow|V0034 CR 01B Vehicle|"cream
V0034CR01B vehicle"
635875|NCT01084148|P1|Participant Flow|V0034CR01B|"cream
V0034CR01B"
635876|NCT01084148|O2|Outcome|V0034 CR 01B Vehicle|"cream
V0034CR01B vehicle"
635877|NCT01084148|O1|Outcome|V0034CR01B|"cream
V0034CR01B"
635878|NCT01084148|E2|Reported Event|V0034 CR 01B Vehicle|"cream
V0034CR01B vehicle"
635879|NCT01084148|E1|Reported Event|V0034CR01B|"cream
V0034CR01B"
635880|NCT01084174|B3|Baseline|Total|Total of all reporting groups
635881|NCT01084174|B2|Baseline|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally"
635882|NCT01084174|B1|Baseline|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually"
635883|NCT01084174|P2|Participant Flow|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally"
635884|NCT01084174|P1|Participant Flow|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually"
635885|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally"
635886|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually"
635887|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally"
635888|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually"
635889|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally"
635890|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually"
635891|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally"
635892|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually"
635893|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally"
635894|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually"
635979|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
635897|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally"
635898|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually"
635899|NCT01084174|E2|Reported Event|Active OIT/Placebo SLIT|Adverse event information is based on percentages of doses. There were 4049 total doses in the Active OIT/Placebo SLIT treatment arm
635900|NCT01084174|E1|Reported Event|Active SLIT/Placebo OIT|Adverse event information is based on percentages of doses. There were 4578 total doses in the Active SLIT/Placebo OIT treatment arm
635901|NCT01084239|B3|Baseline|Total|Total of all reporting groups
635903|NCT01084239|B1|Baseline|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
635904|NCT01084239|P2|Participant Flow|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
635905|NCT01084239|P1|Participant Flow|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
635906|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
635907|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
635908|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
635909|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
635910|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
635911|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
635912|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
635913|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
635914|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
635915|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
635916|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
636251|NCT01077128|O4|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 12|All eligible patients with psoriasis treated with Adalimumab
635917|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
635918|NCT01084239|E2|Reported Event|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
635941|NCT01084278|P2|Participant Flow|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
635942|NCT01084278|P1|Participant Flow|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
635919|NCT01084239|E1|Reported Event|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
635920|NCT01084265|B1|Baseline|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635921|NCT01084265|P1|Participant Flow|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635922|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635923|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635924|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635925|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635926|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635927|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635928|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635929|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635930|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635931|NCT01084265|E1|Reported Event|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
635932|NCT01084278|B6|Baseline|Total|Total of all reporting groups
635933|NCT01084278|B5|Baseline|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
635934|NCT01084278|B4|Baseline|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
635935|NCT01084278|B3|Baseline|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
635936|NCT01084278|B2|Baseline|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
636252|NCT01077128|O3|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 8|All eligible patients with psoriasis treated with Adalimumab
635937|NCT01084278|B1|Baseline|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
635938|NCT01084278|P5|Participant Flow|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
635939|NCT01084278|P4|Participant Flow|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
635940|NCT01084278|P3|Participant Flow|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
635943|NCT01084278|O1|Outcome|End Stage Renal Disease (ESRD)|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken under standard fasting conditions on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
635944|NCT01084278|O1|Outcome|End Stage Renal Disease (ESRD)|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken under standard fasting conditions on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
635945|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
635946|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
635947|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
635948|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
635949|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
635950|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
635951|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
635952|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
635953|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
635954|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
635955|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
635956|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
635957|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
635958|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
635959|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
635960|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
635961|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
635962|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
635963|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
635964|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
635965|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
635966|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
635967|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
635968|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
635969|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
635970|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
635971|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
635972|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
635973|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
635974|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
635975|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
635976|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
635977|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
635978|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
644925|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
635980|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
635981|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
635982|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
635983|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
635984|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
635985|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
635986|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
636073|NCT01084603|P1|Participant Flow|Overall Study|Full Safety Set
635988|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
635989|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
635990|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
635991|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
635992|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
635993|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
635994|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
635995|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
635996|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
635997|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
635998|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
635999|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
636000|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
636001|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
636002|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
636003|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
636004|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
636005|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
636006|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
636007|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
636008|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
636009|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
636010|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
636011|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
636012|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
636013|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
636014|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
636015|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
636016|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
636017|NCT01084278|E5|Reported Event|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
636018|NCT01084278|E4|Reported Event|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
636019|NCT01084278|E3|Reported Event|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
636020|NCT01084278|E2|Reported Event|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
636021|NCT01084278|E1|Reported Event|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
636061|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636062|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
644926|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
636022|NCT01084538|B1|Baseline|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
636023|NCT01084538|P1|Participant Flow|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
636074|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
636075|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
636076|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
636077|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
636024|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
636025|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
636026|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
636027|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
636028|NCT01084538|E1|Reported Event|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
636029|NCT01084551|B4|Baseline|Total|Total of all reporting groups
636030|NCT01084551|B3|Baseline|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636031|NCT01084551|B2|Baseline|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636032|NCT01084551|B1|Baseline|Placebo|0 mg/day for 13 weeks
636033|NCT01084551|P3|Participant Flow|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636034|NCT01084551|P2|Participant Flow|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636035|NCT01084551|P1|Participant Flow|Placebo|0 mg/day for 13 weeks
636036|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636037|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636038|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
636039|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636040|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636041|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
636042|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636043|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636044|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
636045|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636046|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636047|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
636048|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636049|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636050|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
636051|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636052|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636053|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
636054|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636055|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636056|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
636057|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636058|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636059|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
636060|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636063|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636064|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636065|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
636066|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636067|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
636068|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
636069|NCT01084551|E3|Reported Event|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
636085|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
636086|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
636087|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
636088|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
636089|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
636090|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
636091|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
636092|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
636093|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
636094|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
636095|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
636096|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
636097|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
636098|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
636099|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
636100|NCT01084603|E5|Reported Event|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
636101|NCT01084603|E4|Reported Event|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
636102|NCT01084603|E3|Reported Event|Oral Nicotine 4|4 administrations of 1 mg
636103|NCT01084603|E2|Reported Event|Oral Nicotine 2|2 administrations of 1 mg
636104|NCT01084603|E1|Reported Event|Oral Nicotine 1|1 administration of 1 mg
636105|NCT01084668|B1|Baseline|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
636106|NCT01084668|P1|Participant Flow|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
636107|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
636108|NCT01084668|O2|Outcome|Subgroup With Nail Psoriasis|Subgroup of participants with nail psoriasis and a NAPSI score greater than 0 for at least 1 study visit
636109|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
636110|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
636111|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
636112|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
636113|NCT01084668|E1|Reported Event|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
636114|NCT01084707|B1|Baseline|All Randomized Subjects|All subjects randomized into the trial, e.g., Full Analysis Set
636115|NCT01084707|P1|Participant Flow|Overall Study|All subjects randomized into the trial
636116|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
636117|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
636118|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
636119|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
636245|NCT01077076|E3|Reported Event|Placebo Capsules|
636120|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
636121|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
636122|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
636123|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
636124|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
636125|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
636126|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
636127|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
636128|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
636129|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
636130|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
636131|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
636132|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
636133|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
636134|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
636135|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
644041|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
636136|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
636137|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
636138|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
636139|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
636140|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
636141|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
636142|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
636143|NCT01084707|E5|Reported Event|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
636144|NCT01084707|E4|Reported Event|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
636145|NCT01084707|E3|Reported Event|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
636146|NCT01084707|E2|Reported Event|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
636147|NCT01084707|E1|Reported Event|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
636148|NCT01084759|B1|Baseline|Etoposide and Testosterone|Patients will receive an intramuscular gluteal injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).On the day of testosterone injection (i.e. day 1 of each cycle) patients will begin therapy with oral etoposide at a dose of 100 mg/day given in divided doses (one 50 mg etoposide capsule q 12 h) for 14 consecutive days.
636149|NCT01084759|P1|Participant Flow|Testosterone|Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
636150|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
636151|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
636152|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
636153|NCT01084759|E1|Reported Event|Treatment Group|Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
636154|NCT01085006|B3|Baseline|Total|Total of all reporting groups
636155|NCT01085006|B2|Baseline|Normal Saline Infusion|
636156|NCT01085006|B1|Baseline|Tranexamic Acid|
636157|NCT01085006|P2|Participant Flow|Normal Saline Infusion|
636158|NCT01085006|P1|Participant Flow|Tranexamic Acid|
636159|NCT01085006|O2|Outcome|Normal Saline Infusion|
636160|NCT01085006|O1|Outcome|Tranexamic Acid|
636161|NCT01085006|E2|Reported Event|Normal Saline Infusion|
636162|NCT01085006|E1|Reported Event|Tranexamic Acid|
636163|NCT01076959|B1|Baseline|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
636164|NCT01076959|P1|Participant Flow|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
636246|NCT01077076|E2|Reported Event|Prilosec OTC Tablets|20 mg-equivalent omeprazole
636247|NCT01077076|E1|Reported Event|Zegerid OTC Capsules|20 mg omeprazole and 1100 mg sodium bicarbonate
636165|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good and Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
636166|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
636167|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
636168|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 4.at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
636169|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good or Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
636170|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
636171|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
636172|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
636267|NCT01077128|O13|Outcome|EQ5D- Usual Activities- Month 4|All eligible patients with psoriasis treated with Adalimumab
636173|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good or Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
636174|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement <0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
636175|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
636176|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response according to DAS 28 (improvement > 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
636177|NCT01076959|O1|Outcome|Physician Response Rating|The full analysis set was used to determine the physicians' overall response rating.
636178|NCT01076959|O1|Outcome|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
636179|NCT01076959|E1|Reported Event|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
636180|NCT01076972|B1|Baseline|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
636181|NCT01076972|P1|Participant Flow|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
636182|NCT01076972|O7|Outcome|Lopinavir/Ritonavir: Baseline Category Unknown|The subgroup of participants whose CDC classification at Baseline (prior to treatment with lopinavir/ritonavir) was unknown.
636183|NCT01076972|O6|Outcome|Lopinavir/Ritonavir: Baseline Category P-2|The subgroup of participants who were classified as CDC Category P-2 at Baseline (prior to treatment with lopinavir/ritonavir).
636184|NCT01076972|O5|Outcome|Lopinavir/Ritonavir: Baseline Category P-1|The subgroup of participants who were classified as CDC Category P-1 at Baseline (prior to treatment with lopinavir/ritonavir).
636185|NCT01076972|O4|Outcome|Lopinavir/Ritonavir: Baseline Category P-0|The subgroup of participants who were classified as CDC Category P-0 at Baseline (prior to treatment with lopinavir/ritonavir).
636186|NCT01076972|O3|Outcome|Lopinavir/Ritonavir: Baseline Category C|The subgroup of patients who were classified as CDC Category C at Baseline (prior to treatment with lopinavir/ritonavir).
636187|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Baseline Category B|The subgroup of participants who were classified as CDC Category B at Baseline (prior to treatment with lopinavir/ritonavir).
636188|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Baseline Category A|The subgroup of patients who were classified as CDC Category A at Baseline (prior to treatment with lopinavir/ritonavir).
636189|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 418 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
636190|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Treatment-Naive|The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
636191|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Treatment-Experienced|The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 420 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
636248|NCT01077128|B1|Baseline|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
636192|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Treatment-Naive|The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
636193|NCT01076972|O1|Outcome|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
636194|NCT01076972|E1|Reported Event|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
636195|NCT01076985|B1|Baseline|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
636196|NCT01076985|P1|Participant Flow|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
636197|NCT01076985|O2|Outcome|Infants|Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection and participated in this noninterventional, post-marketing observational study.
636198|NCT01076985|O1|Outcome|Lopinavir/Ritonavir|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
636268|NCT01077128|O12|Outcome|EQ5D- Usual Activities- Month 1|All eligible patients with psoriasis treated with Adalimumab
636199|NCT01076985|E2|Reported Event|Infants|Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection who participated in this noninterventional, post-marketing observational study.
636200|NCT01076985|E1|Reported Event|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
636201|NCT01077024|B3|Baseline|Total|Total of all reporting groups
636202|NCT01077024|B2|Baseline|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
636203|NCT01077024|B1|Baseline|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
636204|NCT01077024|P2|Participant Flow|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
636205|NCT01077024|P1|Participant Flow|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
636206|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
636207|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
636208|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
636209|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
636210|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
636211|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
636212|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
636213|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
636214|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
636249|NCT01077128|P1|Participant Flow|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
636250|NCT01077128|O1|Outcome|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab were followed for the long term use and safety of Adalimumab. For more detailed information, please see the Adverse Events section.
636215|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
636216|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
636217|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
636218|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
636219|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
636220|NCT01077024|E2|Reported Event|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
636269|NCT01077128|O11|Outcome|EQ5D- Usual Activities- Baseline|All eligible patients with psoriasis treated with Adalimumab
636538|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
636221|NCT01077024|E1|Reported Event|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
636222|NCT01077050|B1|Baseline|Biopsied Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
636223|NCT01077050|P1|Participant Flow|Only One Arm in the Study, Thus Not Applicable.|
636224|NCT01077050|O1|Outcome|Biopsied Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
636225|NCT01077050|E1|Reported Event|Biopsied Skin Lesions|"Any adverse advent that occured on a skin/lesion site for whom there had been any contact between the subject's skin and investigational device (SciBase III).
Note that multiple adverse event occured on some subjects. In total 36 Adverse Events were reported on 28 subjects."
636226|NCT01077063|B3|Baseline|Total|Total of all reporting groups
636227|NCT01077063|B2|Baseline|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.
Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
636228|NCT01077063|B1|Baseline|Paracentesis|"cutting and draining procedure for malignant ascites
paracentesis: surgical drainage of malignant ascites"
636229|NCT01077063|P2|Participant Flow|Paracentesis|"cutting and draining procedure for malignant ascites
paracentesis: surgical drainage of malignant ascites"
636230|NCT01077063|P1|Participant Flow|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.
Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
636231|NCT01077063|O2|Outcome|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.
Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
636232|NCT01077063|O1|Outcome|Paracentesis|"cutting and draining procedure for malignant ascites
paracentesis: surgical drainage of malignant ascites"
636233|NCT01077063|E2|Reported Event|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.
Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
636234|NCT01077063|E1|Reported Event|Paracentesis|"cutting and draining procedure for malignant ascites
paracentesis: surgical drainage of malignant ascites"
636235|NCT01077076|B1|Baseline|Entire Study Population|
636236|NCT01077076|P6|Participant Flow|Placebo/Prilosec/Zegerid|Participants received Placebo Capsules in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
636237|NCT01077076|P5|Participant Flow|Placebo/Zegerid/Prilosec|Participants received Placebo Capsules in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
636238|NCT01077076|P4|Participant Flow|Prilosec/Placebo/Zegerid|Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
636239|NCT01077076|P3|Participant Flow|Prilosec/Zegerid/Placebo|Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
636240|NCT01077076|P2|Participant Flow|Zegerid/Placebo/Prilosec|Participants received Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
636241|NCT01077076|P1|Participant Flow|Zegerid/Prilosec/Placebo|Participants received Zegerid over-the-counter (OTC) Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
636242|NCT01077076|O3|Outcome|Placebo Capsules|
636243|NCT01077076|O2|Outcome|Prilosec OTC Tablets|20 mg-equivalent omeprazole
636244|NCT01077076|O1|Outcome|Zegerid OTC Capsules|20 mg omeprazole and 1100 mg sodium bicarbonate
636253|NCT01077128|O2|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 4|All eligible patients with psoriasis treated with Adalimumab
636254|NCT01077128|O1|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 1|All eligible patients with psoriasis treated with Adalimumab
636255|NCT01077128|O25|Outcome|EQ5D- Anxiety/Depression- Month 12|All eligible patients with psoriasis treated with Adalimumab
636256|NCT01077128|O24|Outcome|EQ5D- Anxiety/Depression- Month 8|All eligible patients with psoriasis treated with Adalimumab
636257|NCT01077128|O23|Outcome|EQ5D- Anxiety/Depression- Month 4|All eligible patients with psoriasis treated with Adalimumab
636258|NCT01077128|O22|Outcome|EQ5D- Anxiety/Depression- Month 1|All eligible patients with psoriasis treated with Adalimumab
636259|NCT01077128|O21|Outcome|EQ5D- Anxiety/Depression- Baseline|All eligible patients with psoriasis treated with Adalimumab
636260|NCT01077128|O20|Outcome|EQ5D- Pain/Discomfort- Month 12|All eligible patients with psoriasis treated with Adalimumab
636261|NCT01077128|O19|Outcome|EQ5D- Pain/Discomfort- Month 8|All eligible patients with psoriasis treated with Adalimumab
636262|NCT01077128|O18|Outcome|EQ5D- Pain/Discomfort- Month 4|All eligible patients with psoriasis treated with Adalimumab
636263|NCT01077128|O17|Outcome|EQ5D- Pain/Discomfort- Month 1|All eligible patients with psoriasis treated with Adalimumab
636264|NCT01077128|O16|Outcome|EQ5D- Pain/Discomfort- Baseline|All eligible patients with psoriasis treated with Adalimumab
636265|NCT01077128|O15|Outcome|EQ5D- Usual Activities- Month 12|All eligible patients with psoriasis treated with Adalimumab
636266|NCT01077128|O14|Outcome|EQ5D- Usual Activities- Month 8|All eligible patients with psoriasis treated with Adalimumab
636270|NCT01077128|O10|Outcome|EQ5D- Self-care- Month 12|All eligible patients with psoriasis treated with Adalimumab
636271|NCT01077128|O9|Outcome|EQ5D- Self-care- Month 8|All eligible patients with psoriasis treated with Adalimumab
636272|NCT01077128|O8|Outcome|EQ5D- Self-care- Month 4|All eligible patients with psoriasis treated with Adalimumab
636273|NCT01077128|O7|Outcome|EQ5D- Self-care- Month 1|All eligible patients with psoriasis treated with Adalimumab
636274|NCT01077128|O6|Outcome|EQ5D- Self-care- Baseline|All eligible patients with psoriasis treated with Adalimumab
636275|NCT01077128|O5|Outcome|EQ5D- Mobility- Month 12|All eligible patients with psoriasis treated with Adalimumab
636276|NCT01077128|O4|Outcome|EQ5D- Mobility- Month 8|All eligible patients with psoriasis treated with Adalimumab
636277|NCT01077128|O3|Outcome|EQ5D- Mobility- Month 4|All eligible patients with psoriasis treated with Adalimumab
636278|NCT01077128|O2|Outcome|EQ5D- Mobility- Month 1|All eligible patients with psoriasis treated with Adalimumab
636279|NCT01077128|O1|Outcome|EQ5D- Mobility- Baseline|All eligible patients with psoriasis treated with Adalimumab
636280|NCT01077128|O17|Outcome|DLQI Score Change Baseline to Month 12- West Macedonia|All eligible patients with psoriasis treated with Adalimumab
636281|NCT01077128|O16|Outcome|DLQI Score Change Baseline to Month 12- West Greece|All eligible patients with psoriasis treated with Adalimumab
636282|NCT01077128|O15|Outcome|DLQI Score Change Baseline to Month 12- Thessaly|All eligible patients with psoriasis treated with Adalimumab
636283|NCT01077128|O14|Outcome|DLQI Score Change Baseline to Month 12- South Aegean|All eligible patients with psoriasis treated with Adalimumab
636284|NCT01077128|O13|Outcome|DLQI Score Change Baseline to Month 12- Peloponnese|All eligible patients with psoriasis treated with Adalimumab
636285|NCT01077128|O12|Outcome|DLQI Score Change Baseline to Month 12- North Aegean|All eligible patients with psoriasis treated with Adalimumab
636286|NCT01077128|O11|Outcome|DLQI Score Change Baseline to Month 12- Ionian Islands|All eligible patients with psoriasis treated with Adalimumab
636287|NCT01077128|O10|Outcome|DLQI Score Change Baseline to Month 12- Epirus|All eligible patients with psoriasis treated with Adalimumab
636288|NCT01077128|O9|Outcome|DLQI Score Change Baseline to Month 12- East Macedonia/Thrace|All eligible patients with psoriasis treated with Adalimumab
636289|NCT01077128|O8|Outcome|DLQI Score Change Baseline to Month 12- Crete|All eligible patients with psoriasis treated with Adalimumab
636290|NCT01077128|O7|Outcome|DLQI Score Change Baseline to Month 12- Central Macedonia|All eligible patients with psoriasis treated with Adalimumab
636291|NCT01077128|O6|Outcome|DLQI Score Change Baseline to Month 12- Central Greece|All eligible patients with psoriasis treated with Adalimumab
636292|NCT01077128|O5|Outcome|DLQI Score Change Baseline to Month 12- Attica|All eligible patients with psoriasis treated with Adalimumab
636293|NCT01077128|O4|Outcome|DLQI Score Change by PGA Response Group- Month 12|All eligible patients with psoriasis treated with Adalimumab
636294|NCT01077128|O3|Outcome|DLQI Score Change by PGA Response Group- Month 8|All eligible patients with psoriasis treated with Adalimumab
636295|NCT01077128|O2|Outcome|DLQI Score Change by PGA Response Group- Month 4|All eligible patients with psoriasis treated with Adalimumab
636296|NCT01077128|O1|Outcome|DLQI Score Change by PGA Response Group- Month 1|All eligible patients with psoriasis treated with Adalimumab
636297|NCT01077128|O4|Outcome|Patients With Psoriasis- Month 12|All eligible patients with psoriasis treated with Adalimumab
636298|NCT01077128|O3|Outcome|Patients With Psoriasis- Month 8|All eligible patients with psoriasis treated with Adalimumab
636299|NCT01077128|O2|Outcome|Patients With Psoriasis- Month 4|All eligible patients with psoriasis treated with Adalimumab
636300|NCT01077128|O1|Outcome|Patients With Psoriasis- Month 1|All eligible patients with psoriasis treated with Adalimumab
636301|NCT01077128|O4|Outcome|Patients With Psoriasis- Month 12|All eligible patients with psoriasis treated with Adalimumab
636302|NCT01077128|O3|Outcome|Patients With Psoriasis- Month 8|All eligible patients with psoriasis treated with Adalimumab
636303|NCT01077128|O2|Outcome|Patients With Psoriasis- Month 4|All eligible patients with psoriasis treated with Adalimumab
636304|NCT01077128|O1|Outcome|Patients With Psoriasis- Month 1|All eligible patients with psoriasis treated with Adalimumab
636305|NCT01077128|E1|Reported Event|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
636306|NCT01077193|B1|Baseline|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.
The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.
At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
636307|NCT01077193|P1|Participant Flow|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.
The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.
At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
636352|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
636353|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
636390|NCT01077284|B2|Baseline|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
636308|NCT01077193|O1|Outcome|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.
The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.
At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
636309|NCT01077193|E1|Reported Event|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.
The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.
At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
636310|NCT01077258|B1|Baseline|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636311|NCT01077258|P1|Participant Flow|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636312|NCT01077258|O7|Outcome|Month 24|24 months after inclusion
636313|NCT01077258|O6|Outcome|Month 18|18 months after inclusion
636314|NCT01077258|O5|Outcome|Month 12|12 months after inclusion
636315|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
636316|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
636317|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
636318|NCT01077258|O1|Outcome|Month 0|Baseline
636319|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636320|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636321|NCT01077258|O6|Outcome|Month 24|24 months after inclusion
636322|NCT01077258|O5|Outcome|Month 18|18 months after inclusion
636323|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
636324|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
636325|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
636326|NCT01077258|O1|Outcome|Month 0|Baseline
636327|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636328|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636329|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636330|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636331|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636332|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636333|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636334|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636335|NCT01077258|O7|Outcome|Month 24|24 months after inclusion
636336|NCT01077258|O6|Outcome|Month 18|18 months after inclusion
636337|NCT01077258|O5|Outcome|Month 12|12 months after inclusion
636338|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
636339|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
636340|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
636341|NCT01077258|O1|Outcome|Month 0|Baseline
636342|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636343|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636344|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636345|NCT01077258|E1|Reported Event|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
636346|NCT01077271|B5|Baseline|Total|Total of all reporting groups
636347|NCT01077271|B4|Baseline|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
636348|NCT01077271|B3|Baseline|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
636349|NCT01077271|B2|Baseline|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
636350|NCT01077271|B1|Baseline|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
636351|NCT01077271|P1|Participant Flow|Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab|Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
636354|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
636355|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
636356|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
636357|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
636358|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
636359|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
636360|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
636361|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
636362|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
636363|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
636364|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
636365|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
636366|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
636367|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
636368|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
636369|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
636370|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
636371|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
636372|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
636373|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
636374|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
636375|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
636376|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
636377|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
636416|NCT01077310|O3|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
636378|NCT01077271|O4|Outcome|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
636379|NCT01077271|O3|Outcome|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
636380|NCT01077271|O2|Outcome|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
636381|NCT01077271|O1|Outcome|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
636382|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
636383|NCT01077271|O4|Outcome|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
636384|NCT01077271|O3|Outcome|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
636385|NCT01077271|O2|Outcome|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
636386|NCT01077271|O1|Outcome|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
636387|NCT01077271|E1|Reported Event|Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab|Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
636388|NCT01077284|B4|Baseline|Total|Total of all reporting groups
644042|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
636391|NCT01077284|B1|Baseline|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
636392|NCT01077284|P3|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
636393|NCT01077284|P2|Participant Flow|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
636394|NCT01077284|P1|Participant Flow|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
636395|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
636396|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
636397|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
636398|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
636399|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
636400|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
636401|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
636402|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
636403|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
636404|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
636405|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
636406|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
636407|NCT01077284|E3|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
636408|NCT01077284|E2|Reported Event|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
636409|NCT01077284|E1|Reported Event|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
636410|NCT01077310|B3|Baseline|Total|Total of all reporting groups
636411|NCT01077310|B2|Baseline|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
636412|NCT01077310|B1|Baseline|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
636413|NCT01077310|P2|Participant Flow|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
636414|NCT01077310|P1|Participant Flow|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
636415|NCT01077310|O4|Outcome|Placebo, Received 4-6 Injections|
636417|NCT01077310|O2|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
636418|NCT01077310|O1|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
636419|NCT01077310|O4|Outcome|Placebo, Received 4-6 Injections|
636420|NCT01077310|O3|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
636421|NCT01077310|O2|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
636422|NCT01077310|O1|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
636423|NCT01077310|O4|Outcome|Placebo, Received 4-6 Injections|
636424|NCT01077310|O3|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
636425|NCT01077310|O2|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
636426|NCT01077310|O1|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
636427|NCT01077310|O2|Outcome|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
636428|NCT01077310|O1|Outcome|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
636429|NCT01077310|O2|Outcome|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
636430|NCT01077310|O1|Outcome|Intramuscular Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
636431|NCT01077310|E2|Reported Event|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
636432|NCT01077310|E1|Reported Event|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
636433|NCT01077323|B4|Baseline|Total|Total of all reporting groups
636434|NCT01077323|B3|Baseline|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
636563|NCT01077596|P8|Participant Flow|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
636435|NCT01077323|B2|Baseline|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
636436|NCT01077323|B1|Baseline|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
636437|NCT01077323|P3|Participant Flow|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
636438|NCT01077323|P2|Participant Flow|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
636439|NCT01077323|P1|Participant Flow|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
636531|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
636532|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
636440|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
636441|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
636442|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
636443|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
636444|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
636445|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
636446|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
636447|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
636448|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
636449|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
636450|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
636564|NCT01077596|P7|Participant Flow|Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
636451|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
636452|NCT01077323|E3|Reported Event|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
636453|NCT01077323|E2|Reported Event|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
636454|NCT01077323|E1|Reported Event|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
636455|NCT01077362|B4|Baseline|Total|Total of all reporting groups
636456|NCT01077362|B3|Baseline|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636533|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
644043|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
636457|NCT01077362|B2|Baseline|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636458|NCT01077362|B1|Baseline|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
636459|NCT01077362|P3|Participant Flow|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636460|NCT01077362|P2|Participant Flow|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636461|NCT01077362|P1|Participant Flow|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
636462|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
636463|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636464|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636465|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
636466|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
636467|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636468|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636469|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
636470|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
636471|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636472|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636473|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
636474|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
636475|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636476|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636477|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
636478|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
636479|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636480|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636481|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
636482|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
636483|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636484|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
636485|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
636486|NCT01077362|E7|Reported Event|Ustekinumab 90 mg: Weeks 16-60|Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
636487|NCT01077362|E6|Reported Event|Ustekinumab 45 mg: Weeks 16-60|Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
636488|NCT01077362|E5|Reported Event|Placebo -> Ustekinumab 45 mg: Weeks 16-60|Adverse events which occurred (1) during Weeks 16-60 in participants randomly assigned to placebo at Baseline and who early escaped to ustekinumab 45 mg at Week 16 and (2) during Weeks 24-60 in participants randomly assigned to placebo at Baseline and who crossed over to ustekinumab 45 mg at Week 24.
636489|NCT01077362|E4|Reported Event|Placebo: Weeks 16-24|Adverse events which occurred during Weeks 16-24 in participants who were randomly assigned to placebo at Baseline and did not early escape at Week 16.
636490|NCT01077362|E3|Reported Event|Ustekinumab 90 mg: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
636491|NCT01077362|E2|Reported Event|Ustekinumab 45 mg: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
636492|NCT01077362|E1|Reported Event|Placebo: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to placebo at Baseline.
636493|NCT01077375|B3|Baseline|Total|Total of all reporting groups
636819|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636494|NCT01077375|B2|Baseline|Milnacipran|"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 md/day, twice a day in divided doses, oral administration.
One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population."
636495|NCT01077375|B1|Baseline|Placebo|Double-blind Safety Population: Placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
636496|NCT01077375|P2|Participant Flow|Milnacipran|Randomized Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day in divided doses, oral administration.
636497|NCT01077375|P1|Participant Flow|Placebo|Randomized Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
636498|NCT01077375|O2|Outcome|Milnacipran|"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.
Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)"
636499|NCT01077375|O1|Outcome|Placebo|Intent-to-treat Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
636500|NCT01077375|O2|Outcome|Milnacipran|"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.
Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)."
636501|NCT01077375|O1|Outcome|Placebo|Intent-to-treat (ITT) Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
636502|NCT01077375|E2|Reported Event|Milnacipran|"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.
One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population.
Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)."
636503|NCT01077375|E1|Reported Event|Placebo|Double-blind Safety Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
636504|NCT01077401|B3|Baseline|Total|Total of all reporting groups
636505|NCT01077401|B2|Baseline|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
636506|NCT01077401|B1|Baseline|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
636507|NCT01077401|P2|Participant Flow|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
636508|NCT01077401|P1|Participant Flow|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
636509|NCT01077401|O2|Outcome|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
636510|NCT01077401|O1|Outcome|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
636511|NCT01077401|O2|Outcome|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
636512|NCT01077401|O1|Outcome|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
636513|NCT01077401|O2|Outcome|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
636514|NCT01077401|O1|Outcome|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
636565|NCT01077596|P6|Participant Flow|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
636515|NCT01077401|E2|Reported Event|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
636516|NCT01077401|E1|Reported Event|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
636517|NCT01077544|B3|Baseline|Total|Total of all reporting groups
636518|NCT01077544|B2|Baseline|Group 2|>= 10 years to <18 years pediatric patients
636519|NCT01077544|B1|Baseline|Group 1|1 year to < 10 years pediatric patients
636520|NCT01077544|P2|Participant Flow|Group 2|>= 10 years to <18 years pediatric patients
636521|NCT01077544|P1|Participant Flow|Group 1|1 year to < 10 years pediatric patients
636522|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
636523|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
636524|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
636525|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
636526|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
636527|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
636528|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
636529|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
636530|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
636539|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
636540|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
636541|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
636542|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
636543|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
636544|NCT01077544|E2|Reported Event|Group 2|>= 10 years to <18 years pediatric patients
636545|NCT01077544|E1|Reported Event|Group 1|1 year to < 10 years pediatric patients
636546|NCT01077596|B13|Baseline|Total|Total of all reporting groups
636547|NCT01077596|B12|Baseline|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
636548|NCT01077596|B11|Baseline|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
636549|NCT01077596|B10|Baseline|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
636550|NCT01077596|B9|Baseline|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
636551|NCT01077596|B8|Baseline|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
636552|NCT01077596|B7|Baseline|New Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
636553|NCT01077596|B6|Baseline|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
636554|NCT01077596|B5|Baseline|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
636555|NCT01077596|B4|Baseline|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
636556|NCT01077596|B3|Baseline|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
636557|NCT01077596|B2|Baseline|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
636558|NCT01077596|B1|Baseline|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
636559|NCT01077596|P12|Participant Flow|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
636560|NCT01077596|P11|Participant Flow|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
636561|NCT01077596|P10|Participant Flow|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
636562|NCT01077596|P9|Participant Flow|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
636751|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
636566|NCT01077596|P5|Participant Flow|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
636567|NCT01077596|P4|Participant Flow|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
636568|NCT01077596|P3|Participant Flow|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
636569|NCT01077596|P2|Participant Flow|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
636570|NCT01077596|P1|Participant Flow|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
636571|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
636572|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
636573|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
636574|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
636575|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
636576|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
636577|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
636578|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
636715|NCT01077817|O6|Outcome|Raloxifene|Participants who initiated osteoporosis treatment with raloxifene
636579|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
636580|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
636581|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
636582|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
636583|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
636584|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
636585|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
636586|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
636587|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
636588|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
636589|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
636590|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
636591|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
636592|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
636593|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
636594|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
636595|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
636596|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
636597|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
636752|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
644927|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
636598|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
636599|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
636600|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
636601|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular “other” antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date
636602|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
636603|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
636604|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
636605|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
636606|NCT01077596|E12|Reported Event|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
636607|NCT01077596|E11|Reported Event|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
636608|NCT01077596|E10|Reported Event|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
636609|NCT01077596|E9|Reported Event|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
636610|NCT01077596|E8|Reported Event|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
644044|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
636611|NCT01077596|E7|Reported Event|New Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
636612|NCT01077596|E6|Reported Event|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
636613|NCT01077596|E5|Reported Event|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
636614|NCT01077596|E4|Reported Event|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
636615|NCT01077596|E3|Reported Event|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
636616|NCT01077596|E2|Reported Event|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
636617|NCT01077596|E1|Reported Event|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
636618|NCT01077622|B1|Baseline|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636619|NCT01077622|P1|Participant Flow|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636620|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636621|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636622|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636623|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636624|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636625|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636626|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636627|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636628|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636629|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636630|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636631|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636632|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636633|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636634|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636848|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636635|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636636|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636637|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636638|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636639|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636640|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636641|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636642|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636643|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636644|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636645|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636646|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636647|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636703|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
636648|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636649|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636650|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636651|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636652|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636653|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636654|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636655|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636656|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636657|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636658|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636659|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636660|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636661|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636662|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636663|NCT01077622|E1|Reported Event|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
636664|NCT01077713|B3|Baseline|Total|Total of all reporting groups
636665|NCT01077713|B2|Baseline|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636666|NCT01077713|B1|Baseline|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636667|NCT01077713|P2|Participant Flow|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636668|NCT01077713|P1|Participant Flow|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m^2) IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636748|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
636669|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636670|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636671|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636672|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636673|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636674|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636711|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
636675|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636676|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636677|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636678|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636679|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636680|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636681|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636682|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636683|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636684|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636685|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636749|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
636750|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
636686|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636687|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636688|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636689|NCT01077713|E2|Reported Event|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
636690|NCT01077713|E1|Reported Event|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
636691|NCT01077739|B3|Baseline|Total|Total of all reporting groups
636712|NCT01077804|E1|Reported Event|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
636713|NCT01077817|B1|Baseline|Overall Study Population|
636692|NCT01077739|B2|Baseline|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
636693|NCT01077739|B1|Baseline|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
636694|NCT01077739|P2|Participant Flow|Bevacizumab + 5-fluorouracil/Oxaliplatin/Leucovorin (FOLFOX)|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-fluorouracil [5-FU] plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
636695|NCT01077739|P1|Participant Flow|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1; oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1; and capecitabine 1000 mg/m^2, orally (PO), twice daily (BID) on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
636696|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
636697|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
636698|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
636699|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
636700|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
636701|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
636702|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
636814|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636704|NCT01077739|E2|Reported Event|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
636705|NCT01077739|E1|Reported Event|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
636706|NCT01077804|B1|Baseline|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
636707|NCT01077804|P1|Participant Flow|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
636708|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
636709|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
636710|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
636716|NCT01077817|O5|Outcome|Risendronate|Participants who initiated osteoporosis treatment with risedronate
636717|NCT01077817|O4|Outcome|Ibandronate|Participants who initiated osteoporosis treatment with ibandronate
636718|NCT01077817|O3|Outcome|Etidronate|Participants who initiated osteoporosis treatment with etidronate
636719|NCT01077817|O2|Outcome|Alendronate|Participants who initiated osteoporosis treatment with alendronate
636720|NCT01077817|O1|Outcome|Comparators|Participants who did not initiate osteoporosis treatment with a study drug
636721|NCT01077817|O2|Outcome|Comparison Sample (Case Cohort)|Participants who were matched to cases by age and membership in the GPRD on the case's onset date, and had not experienced any form of esophageal cancer or Paget's Disease and had not received oral or intravenous steroids or chemotherapy or radiotherapy, as indicated by GPRD codes.
636722|NCT01077817|O1|Outcome|Esophageal Cancer Cohort|Participants with any GPRD Medical Code for esophageal cancer (cases).
636723|NCT01077817|E1|Reported Event|Overall Study Population|
636724|NCT01077830|B3|Baseline|Total|Total of all reporting groups
636725|NCT01077830|B2|Baseline|Placebo|Participants who received placebo in the base study
636726|NCT01077830|B1|Baseline|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
636727|NCT01077830|P2|Participant Flow|Placebo|Participantss who received placebo in the base study
636728|NCT01077830|P1|Participant Flow|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
636729|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
636730|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
636731|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
636732|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
636733|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
636734|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
636735|NCT01077830|E2|Reported Event|Placebo|Participants who were assigned to the placebo cohort in the base study
636736|NCT01077830|E1|Reported Event|Ezetimibe/Simvastatin 10/40 mg|Participants who were assigned to the Ezetimibe/Simvastatin 10/40 mg cohort in the base study
636737|NCT01077856|B4|Baseline|Total|Total of all reporting groups
636738|NCT01077856|B3|Baseline|Sweden Participants|Participants in Sweden who completed the first survey (before licensure of GARDASIL)
636739|NCT01077856|B2|Baseline|Norway Participants|Participants in Norway who completed the first survey (before licensure of GARDASIL)
636740|NCT01077856|B1|Baseline|Denmark Participants|Participants in Denmark who completed the first survey (before licensure of GARDASIL)
636741|NCT01077856|P3|Participant Flow|Sweden Participants|Participants in Sweden who completed the first survey (before licensure of GARDASIL)
636742|NCT01077856|P2|Participant Flow|Norway Participants|Participants in Norway who completed the first survey (before licensure of GARDASIL)
636743|NCT01077856|P1|Participant Flow|Denmark Participants|Participants in Denmark who completed the first survey (before licensure of GARDASIL)
636744|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
636745|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
636746|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
636747|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
636753|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
636754|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
636755|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
636756|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
636757|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
636758|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
636759|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
636760|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
636761|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
636762|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
636763|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
636764|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
636765|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
636766|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
636767|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
636768|NCT01077856|O6|Outcome|Babies Born to Sweden Participants|Live babies born between 2007 and 2011 to Sweden participants in the general population, including participants who did and did not received Gardasil
636769|NCT01077856|O5|Outcome|Babies Born to Sweden Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Sweden participants who received Gardasil during pregnancy
636770|NCT01077856|O4|Outcome|Babies Born to Norway Participants|Live babies born between 2007 and 2011 to Norway participants in the general population, including participants who did and did not receive Gardasil
636771|NCT01077856|O3|Outcome|Babies Born to Norway Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Norway participants who received Gardasil during pregnancy
636772|NCT01077856|O2|Outcome|Babies Born to Denmark Participants|Live babies born between 2007 and 2011 to Denmark participants in the general population, including participants who did and did not receive Gardasil
636773|NCT01077856|O1|Outcome|Babies Born to Denmark Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Denmark participants who received Gardasil during pregnancy
636774|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636775|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636776|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636777|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636778|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636779|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636780|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636781|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636782|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636783|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636784|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636785|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636786|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636787|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636788|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636789|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636790|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636791|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636792|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636793|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636794|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636795|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636796|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636797|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636798|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636799|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636800|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636801|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636802|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636803|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636804|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636805|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636806|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636807|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636808|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636809|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636810|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636811|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636812|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636813|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636820|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636821|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636822|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636823|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636824|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636825|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636826|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636827|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636828|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636829|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636830|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636831|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636832|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636833|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636834|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636835|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636836|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636837|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636838|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636839|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636840|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636841|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636842|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636843|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636844|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636845|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636846|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636847|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636849|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636850|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636851|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636852|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636853|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636854|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636855|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636856|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636857|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636858|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
636859|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636860|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
636861|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636862|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
636863|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636864|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
636865|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
636866|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
636867|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
636868|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
636869|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636870|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
636871|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
636872|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
636873|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
636874|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
636875|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636876|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
636877|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
636878|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
636879|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
636880|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
636881|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
636882|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
636883|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
636884|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
636885|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
636886|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
636887|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636888|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
636889|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
636890|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
636891|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
636892|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
636893|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636894|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
636895|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
636896|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
636897|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
636898|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
636899|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
636900|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
636901|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
636902|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
636903|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
636904|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
636905|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636906|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
636907|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
636908|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
636909|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
636910|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
636911|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636912|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
636913|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
636914|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
636915|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
636916|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
636917|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
636918|NCT01077856|E3|Reported Event|Sweden Participants|All Sweden study participants
636919|NCT01077856|E2|Reported Event|Norway Participants|All Norway study participants
636920|NCT01077856|E1|Reported Event|Denmark Participants|All Denmark study participants
636921|NCT01077921|B3|Baseline|Total|Total of all reporting groups
636922|NCT01077921|B2|Baseline|Placebo-first|Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period
636923|NCT01077921|B1|Baseline|Propranolol-first|Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
636924|NCT01077921|P2|Participant Flow|Placebo-first|Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period.
636925|NCT01077921|P1|Participant Flow|Propranolol-first|Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
636926|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636927|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636928|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636929|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636930|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636931|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636932|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636933|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636934|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636935|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636936|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636937|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636938|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636939|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636940|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636941|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636942|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636943|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636944|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636945|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636946|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636947|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636948|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
636949|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636950|NCT01077921|O2|Outcome|Placebo|All subjects completing the placebo treatment phase.
636951|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
636952|NCT01077921|E2|Reported Event|Placebo|Placebo: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
644928|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
636953|NCT01077921|E1|Reported Event|Propranolol|Propranolol: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
636954|NCT01077960|B1|Baseline|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
636955|NCT01077960|P1|Participant Flow|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
636956|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
636957|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
636958|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
636959|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
636960|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
636961|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
636962|NCT01077960|E1|Reported Event|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
636963|NCT01077973|B4|Baseline|Total|Total of all reporting groups
636964|NCT01077973|B3|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636965|NCT01077973|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636966|NCT01077973|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636967|NCT01077973|P3|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636968|NCT01077973|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636969|NCT01077973|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636970|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636971|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636972|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636973|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636974|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636975|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636976|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636977|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636978|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636979|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636980|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636981|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636982|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636983|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636984|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636985|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636986|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636987|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636988|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636989|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636990|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636991|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636992|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636993|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637033|NCT01078090|O2|Outcome|Month 6|6 months after inclusion
637034|NCT01078090|O1|Outcome|Month 0|Baseline
636994|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636995|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636996|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636997|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
636998|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
636999|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637000|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637001|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
637002|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637003|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637004|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
637005|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637006|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637007|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
637008|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637009|NCT01077973|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637010|NCT01077973|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
637011|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
637259|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637012|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637013|NCT01077973|E3|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637014|NCT01077973|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
637015|NCT01077973|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
637016|NCT01078090|B1|Baseline|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637017|NCT01078090|P1|Participant Flow|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637018|NCT01078090|O10|Outcome|Month 60|60 months after inclusion
637019|NCT01078090|O9|Outcome|Month 48|48 months after inclusion
637020|NCT01078090|O8|Outcome|Month 36|36 months after inclusion
637021|NCT01078090|O7|Outcome|Month 30|30 months after inclusion
637022|NCT01078090|O6|Outcome|Month 24|24 months after inclusion
637023|NCT01078090|O5|Outcome|Month 18|18 months after inclusion
637024|NCT01078090|O4|Outcome|Month 12|12 months after inclusion
637025|NCT01078090|O3|Outcome|Month 6|6 months after inclusion
637026|NCT01078090|O2|Outcome|Month 3|3 months after inclusion
637027|NCT01078090|O1|Outcome|Month 0|Baseline
637028|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637029|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637030|NCT01078090|O5|Outcome|Month 30|30 months after inclusion
637031|NCT01078090|O4|Outcome|Month 24|24 months after inclusion
637032|NCT01078090|O3|Outcome|Month 18|18 months after inclusion
637035|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637036|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637037|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637038|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637039|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637040|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637041|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637042|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637043|NCT01078090|O10|Outcome|Month 60|60 months after inclusion
637044|NCT01078090|O9|Outcome|Month 48|48 months after inclusion
637045|NCT01078090|O8|Outcome|Month 36|36 months after inclusion
637046|NCT01078090|O7|Outcome|Month 30|30 months after inclusion
637047|NCT01078090|O6|Outcome|Month 24|24 months after inclusion
637048|NCT01078090|O5|Outcome|Month 18|18 months after inclusion
637049|NCT01078090|O4|Outcome|Month 12|12 months after inclusion
637050|NCT01078090|O3|Outcome|Month 6|6 months after inclusion
637051|NCT01078090|O2|Outcome|Month 3|3 months after inclusion
637052|NCT01078090|O1|Outcome|Month 0|Baseline
637053|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637054|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637055|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637056|NCT01078090|E1|Reported Event|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
637057|NCT01078116|B1|Baseline|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
637058|NCT01078116|P1|Participant Flow|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
637059|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
637060|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
637061|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
637062|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
637063|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
637064|NCT01078116|E1|Reported Event|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
637065|NCT01078155|B1|Baseline|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637066|NCT01078155|P1|Participant Flow|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-tumor necrosis factor (TNF) was taken prior to a participant’s enrollment in the study.
637067|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637068|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637069|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637070|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637071|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637072|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637073|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637074|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637075|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637076|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637260|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637077|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637078|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637079|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637080|NCT01078155|E1|Reported Event|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
637081|NCT01078207|B1|Baseline|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
637082|NCT01078207|P1|Participant Flow|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
637083|NCT01078207|O1|Outcome|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
637227|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
644045|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
637084|NCT01078207|O1|Outcome|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
637085|NCT01078207|E1|Reported Event|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
637086|NCT01078220|B1|Baseline|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
637087|NCT01078220|P1|Participant Flow|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
637088|NCT01078220|O2|Outcome|3-Dose Safety Population|Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
637089|NCT01078220|O1|Outcome|Any Dose Safety Population|Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.
637090|NCT01078220|O1|Outcome|Autoimmune Safety Population|Any female with at least 12 months of membership at a MCO prior to their first dose of Gardasil, in order to exclude pre-existing conditions prior to their first dose of Gardasil.
637091|NCT01078220|O1|Outcome|Pregnancy Safety Population|Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.
637092|NCT01078220|O1|Outcome|Pregnancy Safety Population|Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.
637093|NCT01078220|O2|Outcome|3-Dose Safety Population|Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
637094|NCT01078220|O1|Outcome|Any Dose Safety Population|Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.
637095|NCT01078220|E1|Reported Event|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
637096|NCT01078233|B7|Baseline|Total|Total of all reporting groups
637097|NCT01078233|B6|Baseline|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.
637098|NCT01078233|B5|Baseline|Concurrent Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
637099|NCT01078233|B4|Baseline|Historical and Concurrent Cohorts|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
637261|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
644929|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
637100|NCT01078233|B3|Baseline|Historical Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
637101|NCT01078233|B2|Baseline|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
637102|NCT01078233|B1|Baseline|Raltegravir Cohort Only|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
637103|NCT01078233|P6|Participant Flow|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.
637104|NCT01078233|P5|Participant Flow|Concurrent Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
637105|NCT01078233|P4|Participant Flow|Historical and Concurrent Cohorts|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
637228|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637106|NCT01078233|P3|Participant Flow|Historical Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
637107|NCT01078233|P2|Participant Flow|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
637108|NCT01078233|P1|Participant Flow|Raltegravir Cohort Only|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
637109|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
637110|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
637111|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637112|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
637113|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
637114|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637115|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
637116|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
637138|NCT01078246|P1|Participant Flow|Raltegravir Cohort Only|Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
637117|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637118|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
637119|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
637120|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637121|NCT01078233|E3|Reported Event|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
637122|NCT01078233|E2|Reported Event|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
637123|NCT01078233|E1|Reported Event|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637124|NCT01078246|B8|Baseline|Total|Total of all reporting groups
637125|NCT01078246|B7|Baseline|Historical, Concurrent and Raltegravir Cohorts|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.
637126|NCT01078246|B6|Baseline|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
637127|NCT01078246|B5|Baseline|Concurrent Cohort Only|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
637128|NCT01078246|B4|Baseline|Historical and Concurrent Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
637129|NCT01078246|B3|Baseline|Historical Cohort Only|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
637130|NCT01078246|B2|Baseline|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
637131|NCT01078246|B1|Baseline|Raltegravir Cohort Only|Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
637132|NCT01078246|P7|Participant Flow|Historical, Concurrent and Raltegravir Cohorts|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.
637133|NCT01078246|P6|Participant Flow|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
637134|NCT01078246|P5|Participant Flow|Concurrent Cohort Only|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
637135|NCT01078246|P4|Participant Flow|Historical and Concurrent Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
637136|NCT01078246|P3|Participant Flow|Historical Cohort Only|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
637137|NCT01078246|P2|Participant Flow|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
637211|NCT01078376|B5|Baseline|Total|Total of all reporting groups
637139|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637140|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
637141|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637142|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637143|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
637144|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637145|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637146|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
637147|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637380|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
637148|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637149|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
637150|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637151|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637152|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
637153|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637154|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637155|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
637156|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637157|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637158|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
637159|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637160|NCT01078246|E3|Reported Event|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637161|NCT01078246|E2|Reported Event|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
637162|NCT01078246|E1|Reported Event|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
637163|NCT01078298|B3|Baseline|Total|Total of all reporting groups
637212|NCT01078376|B4|Baseline|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637164|NCT01078298|B2|Baseline|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637165|NCT01078298|B1|Baseline|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637166|NCT01078298|P2|Participant Flow|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637167|NCT01078298|P1|Participant Flow|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637168|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637169|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637170|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637193|NCT01078363|B2|Baseline|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637171|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637172|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637173|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637174|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637175|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637176|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637177|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637178|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637179|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637180|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637181|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637182|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637183|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637184|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637258|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637185|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637186|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637187|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637188|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637189|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637190|NCT01078298|E2|Reported Event|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637191|NCT01078298|E1|Reported Event|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
637192|NCT01078363|B3|Baseline|Total|Total of all reporting groups
637194|NCT01078363|B1|Baseline|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637195|NCT01078363|P2|Participant Flow|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637196|NCT01078363|P1|Participant Flow|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637197|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637198|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637199|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637200|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637201|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637202|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637203|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.
Placebo: Use of a placebo post heart Transplant for Blood pressure control."
637204|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.
ramipril: Use of a ACE ( angiotension converting enzyme) inhibitors post heart Transplant for Blood pressure control."
637205|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637206|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637207|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637208|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637209|NCT01078363|E2|Reported Event|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637210|NCT01078363|E1|Reported Event|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.
ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
637213|NCT01078376|B3|Baseline|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
637214|NCT01078376|B2|Baseline|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
637215|NCT01078376|B1|Baseline|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637216|NCT01078376|P4|Participant Flow|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637217|NCT01078376|P3|Participant Flow|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
637218|NCT01078376|P2|Participant Flow|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
637219|NCT01078376|P1|Participant Flow|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637220|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637221|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637222|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637223|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637224|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637225|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637226|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637229|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637230|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637231|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637232|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637233|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637234|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637235|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637236|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637237|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637238|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637239|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637240|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637241|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637242|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637243|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637244|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637245|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637246|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637247|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637248|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637249|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637250|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637251|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637252|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637253|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637254|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637255|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637256|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637257|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637262|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637263|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637264|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637265|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637266|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637267|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637268|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637269|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637270|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637271|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637272|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637273|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637274|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637275|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637276|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637277|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637278|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637279|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637280|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637281|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637282|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637283|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637284|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637285|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637286|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637287|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637288|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637289|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637290|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637291|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637292|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637293|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637294|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637295|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637296|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637297|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637298|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637299|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637300|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637301|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637302|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637303|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637304|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637305|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637306|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637307|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637308|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637309|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637310|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637311|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637312|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637313|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637314|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637315|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637316|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637317|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637318|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637319|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637320|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637321|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637322|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637323|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637324|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637325|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637326|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637327|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
637328|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637329|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637330|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
637331|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
637332|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637333|NCT01078376|E4|Reported Event|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
637334|NCT01078376|E3|Reported Event|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
637335|NCT01078376|E2|Reported Event|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
637336|NCT01078376|E1|Reported Event|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
637337|NCT01078389|B3|Baseline|Total|Total of all reporting groups
637338|NCT01078389|B2|Baseline|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
637339|NCT01078389|B1|Baseline|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
637340|NCT01078389|P2|Participant Flow|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
637341|NCT01078389|P1|Participant Flow|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
637342|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
637343|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
637344|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
637345|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
637346|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
637347|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
637348|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
637349|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
637350|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
637351|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
637352|NCT01078389|E2|Reported Event|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
637353|NCT01078389|E1|Reported Event|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
637354|NCT01078402|B4|Baseline|Total|Total of all reporting groups
637355|NCT01078402|B3|Baseline|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
637356|NCT01078402|B2|Baseline|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
637357|NCT01078402|B1|Baseline|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
637358|NCT01078402|P3|Participant Flow|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
637359|NCT01078402|P2|Participant Flow|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
637360|NCT01078402|P1|Participant Flow|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
637361|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
637362|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
637363|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
637364|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
637365|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
637366|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
637367|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
637368|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
637369|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
637370|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
637371|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
637372|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
637373|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
637374|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
637375|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
637376|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
637377|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
637378|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
637379|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
637381|NCT01078402|O2|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
637382|NCT01078402|O1|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
637383|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
637384|NCT01078402|E4|Reported Event|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
637385|NCT01078402|E3|Reported Event|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
637386|NCT01078402|E2|Reported Event|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
637387|NCT01078402|E1|Reported Event|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
637388|NCT01078441|B1|Baseline|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
liposomal doxorubicin: Given IV
bortezomib: Given subcutaneously.
dexamethasone: Given orally
cyclophosphamide: Given IV"
637389|NCT01078441|P1|Participant Flow|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
liposomal doxorubicin: Given IV
bortezomib: Given subcutaneously.
dexamethasone: Given orally
cyclophosphamide: Given IV"
637390|NCT01078441|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
liposomal doxorubicin: Given IV
bortezomib: Given subcutaneously.
dexamethasone: Given orally
cyclophosphamide: Given IV"
637391|NCT01078441|E1|Reported Event|Combination Chemotherapy|Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
637392|NCT01078454|B3|Baseline|Total|Total of all reporting groups
637393|NCT01078454|B2|Baseline|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
637394|NCT01078454|B1|Baseline|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
637395|NCT01078454|P2|Participant Flow|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
637396|NCT01078454|P1|Participant Flow|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
637397|NCT01078454|O2|Outcome|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
637398|NCT01078454|O1|Outcome|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
637399|NCT01078454|E2|Reported Event|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
637400|NCT01078454|E1|Reported Event|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
637401|NCT01078545|B1|Baseline|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
637402|NCT01078545|P1|Participant Flow|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
637403|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
637404|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
637405|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
644046|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
637406|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
637407|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
637408|NCT01078545|E1|Reported Event|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
637409|NCT01078571|B1|Baseline|Adalimumab (Humira)|
637410|NCT01078571|P1|Participant Flow|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
637411|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months|Participants who had been taking adalimumab for 4 months or longer.
637412|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time four months or less before the baseline visit were classified as de novo participants."
637413|NCT01078571|O2|Outcome|Adalimumab (Treatment for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
637414|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
637415|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
637416|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
637417|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
637418|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
637419|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
637420|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
637421|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
637422|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
637423|NCT01078571|O1|Outcome|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
637424|NCT01078571|E1|Reported Event|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
637425|NCT01078584|B1|Baseline|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637522|NCT01078623|P5|Participant Flow|Sequence 5|Placebo - FDC 200/6 - FDC 200/12 - Aclidinium 200
637426|NCT01078584|P1|Participant Flow|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637427|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637428|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
637429|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637430|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
637431|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637432|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
637544|NCT01078623|E3|Reported Event|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
637551|NCT01078662|B2|Baseline|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
637433|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637434|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637435|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637436|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637437|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637438|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637439|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637440|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
637441|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
637442|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
637523|NCT01078623|P4|Participant Flow|Sequence 4|Formoterol 12 - Placebo - FDC 200/6 - FDC 200/12
644930|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
637443|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
637444|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
637445|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
637446|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
637447|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
637448|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
637449|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
637450|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
637451|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
637452|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637453|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637454|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637455|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637456|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637457|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637458|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
637524|NCT01078623|P3|Participant Flow|Sequence 3|Aclidinium 200 - Formoterol 12 - Placebo - FDC 200/6
637459|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637460|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637461|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637462|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
637463|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637464|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637545|NCT01078623|E2|Reported Event|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
637546|NCT01078623|E1|Reported Event|Placebo|Placebo twice daily
637547|NCT01078662|B6|Baseline|Total|Total of all reporting groups
637465|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637466|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
637467|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637468|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637469|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637470|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
637471|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637472|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637473|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637474|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637475|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637525|NCT01078623|P2|Participant Flow|Sequence 2|FDC 200/12 - Aclidinium 200 - Formoterol 12 - Placebo
637526|NCT01078623|P1|Participant Flow|Sequence 1|FDC 200/6 μg - FDC 200/12 μg - Aclidinium 200 μg - Formoterol 12 μg
637476|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637477|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
637478|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
637479|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
637480|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637481|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637482|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637483|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637484|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637485|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637486|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637487|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637488|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637489|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637490|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
637491|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
637492|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637493|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
637494|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
637495|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637496|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
637497|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
637548|NCT01078662|B5|Baseline|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
637549|NCT01078662|B4|Baseline|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
637498|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637499|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637500|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637501|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637502|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637503|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637504|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637505|NCT01078584|E1|Reported Event|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
637506|NCT01078623|B1|Baseline|Overall Study Population|All patients randomized into the study
637507|NCT01078623|P20|Participant Flow|Sequence 20|Placebo - Formoterol 12 - Aclidinium 200 - FDC 200/12
637508|NCT01078623|P19|Participant Flow|Sequence 19|Formoterol 12 - Aclidinium 200 - FDC 200/12 - FDC 200/6
637509|NCT01078623|P18|Participant Flow|Sequence 18|Aclidinium 200 - FDC 200/12 - FDC 200/6 - Placebo
637510|NCT01078623|P17|Participant Flow|Sequence 17|FDC 200/12 - FDC 200/6 - Placebo - Formoterol 12
637511|NCT01078623|P16|Participant Flow|Sequence 16|FDC 200/6 - Placebo - Formoterol 12 - Aclidinium 200
637512|NCT01078623|P15|Participant Flow|Sequence 15|Placebo - Aclidinium 200 - FDC 200/6 - Formoterol 12
637513|NCT01078623|P14|Participant Flow|Sequence 14|Formoterol 12 - FDC 200/12 - Placebo - Aclidinium 200
637514|NCT01078623|P13|Participant Flow|Sequence 13|Aclidinium 200 - FDC 200/6 - Formoterol 12 - FDC 200/12
637515|NCT01078623|P12|Participant Flow|Sequence 12|FDC 200/12 - Placebo - Aclidinium 200 - FDC 200/6
637516|NCT01078623|P11|Participant Flow|Sequence 11|FDC 200/6 - Formoterol 12 - FDC 200/12 - Placebo
637517|NCT01078623|P10|Participant Flow|Sequence 10|Placebo - FDC 200/12 - Formoterol 12 - FDC 200/6
637518|NCT01078623|P9|Participant Flow|Sequence 9|Formoterol 12 - FDC 200/6 - Aclidinium 200 - Placebo
637519|NCT01078623|P8|Participant Flow|Sequence 8|Aclidinium 200 - Placebo - FDC 200/12 - Formoterol 12
637520|NCT01078623|P7|Participant Flow|Sequence 7|FDC 200/12 - Formoterol 12 - FDC 200/6 - Aclidinium 200
637521|NCT01078623|P6|Participant Flow|Sequence 6|FDC 200/6 - Aclidinium 200 - Placebo - FDC 200/12
637527|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
637528|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
637529|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
637530|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
637531|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
637532|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
637533|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
637534|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
637535|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
637536|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
637537|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
637538|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
637539|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
637540|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
637541|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
637542|NCT01078623|E5|Reported Event|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
637543|NCT01078623|E4|Reported Event|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
637550|NCT01078662|B3|Baseline|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
637552|NCT01078662|B1|Baseline|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
637553|NCT01078662|P5|Participant Flow|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
637554|NCT01078662|P4|Participant Flow|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
637555|NCT01078662|P3|Participant Flow|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
637556|NCT01078662|P2|Participant Flow|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
637557|NCT01078662|P1|Participant Flow|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
637558|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
637559|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
637560|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
637561|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
637562|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
637563|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
637564|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
637565|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
637566|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
637567|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
637568|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
637569|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
637570|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
637571|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
637572|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
637573|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
637574|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
637575|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
637576|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
637577|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
637578|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
637579|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
637580|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
637581|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
637582|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
637705|NCT01091116|B2|Baseline|Mid Dose|two doses
637583|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
637584|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
637585|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
637586|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
637587|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
637588|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
637589|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
637590|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
637591|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
637592|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
637593|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
637594|NCT01078662|E1|Reported Event|OLAPARIB|
637595|NCT01078675|B3|Baseline|Total|Total of all reporting groups
637596|NCT01078675|B2|Baseline|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
637597|NCT01078675|B1|Baseline|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637598|NCT01078675|P2|Participant Flow|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
637599|NCT01078675|P1|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637600|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637601|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
637602|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
637603|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637604|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637605|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637606|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637607|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637608|NCT01078675|O2|Outcome|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
637609|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637610|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637611|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
637612|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637613|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637614|NCT01078675|E1|Reported Event|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
637615|NCT01078753|B3|Baseline|Total|Total of all reporting groups
637616|NCT01078753|B2|Baseline|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
637617|NCT01078753|B1|Baseline|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
637618|NCT01078753|P2|Participant Flow|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
637619|NCT01078753|P1|Participant Flow|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
637620|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
637621|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
637622|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
637623|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
637624|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
637706|NCT01091116|B1|Baseline|Low Dose|two doses
637707|NCT01091116|P5|Participant Flow|Placebo|two intra-articular placebo doses
637625|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
637626|NCT01078753|E2|Reported Event|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
637627|NCT01078753|E1|Reported Event|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
637628|NCT01078805|B1|Baseline|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637629|NCT01078805|P1|Participant Flow|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637630|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637631|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637632|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637633|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637634|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637635|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637636|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637637|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637638|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637639|NCT01078805|E1|Reported Event|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
637640|NCT01078844|B1|Baseline|All Participants|"Treatment as usual plus memantine
memantine: memantine 5-20 mg daily
OR
Treatment as usual plus Placebo"
637641|NCT01078844|P1|Participant Flow|All Participants|"Treatment as usual plus memantine
memantine: memantine 5-20 mg daily
OR
Treatment as usual plus Placebo"
637642|NCT01078844|O2|Outcome|Memantine|"Treatment as usual plus memantine
memantine: memantine 5-20 mg daily"
637643|NCT01078844|O1|Outcome|Placebo|"Treatment as usual plus placebo
Placebo: Look-alike placebo"
637644|NCT01078844|E1|Reported Event|All Participants|"Treatment as usual plus memantine
memantine: memantine 5-20 mg daily
OR
Treatment as usual plus Placebo"
637645|NCT01078909|B6|Baseline|Total|Total of all reporting groups
637646|NCT01078909|B5|Baseline|Placebo|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
637647|NCT01078909|B4|Baseline|1800mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
637648|NCT01078909|B3|Baseline|900mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 65 month supplementation period
637649|NCT01078909|B2|Baseline|600mg Fish Oil (EPA+DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
637650|NCT01078909|B1|Baseline|300mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
637651|NCT01078909|P5|Participant Flow|Placebo|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
637652|NCT01078909|P4|Participant Flow|1800mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
637653|NCT01078909|P3|Participant Flow|900mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
637654|NCT01078909|P2|Participant Flow|600mg Fish Oil (EPA+DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
637655|NCT01078909|P1|Participant Flow|300mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
637656|NCT01078909|O5|Outcome|Placebo|
637657|NCT01078909|O4|Outcome|1800mg Fish Oil (EPA + DHA) Supplement|
637658|NCT01078909|O3|Outcome|900mg Fish Oil (EPA + DHA) Supplement|
637659|NCT01078909|O2|Outcome|600mg Fish Oil (EPA+DHA) Supplement|
637660|NCT01078909|O1|Outcome|300mg Fish Oil (EPA + DHA) Supplement|
637661|NCT01078909|O5|Outcome|Placebo|
637662|NCT01078909|O4|Outcome|1800mg Fish Oil (EPA + DHA) Supplement|
637663|NCT01078909|O3|Outcome|900mg Fish Oil (EPA + DHA) Supplement|
637664|NCT01078909|O2|Outcome|600mg Fish Oil (EPA+DHA) Supplement|
637665|NCT01078909|O1|Outcome|300mg Fish Oil (EPA + DHA) Supplement|
637666|NCT01078909|E5|Reported Event|0 mg/d EPA + DHA (Placebo)|
637667|NCT01078909|E4|Reported Event|1800 mg/d EPA + DHA (Fish Oil) Supplement|
637668|NCT01078909|E3|Reported Event|900 mg/d EPA + DHA (Fish Oil) Supplement|
637669|NCT01078909|E2|Reported Event|600 mg/d EPA + DHA (Fish Oil) Supplement|
637670|NCT01078909|E1|Reported Event|300 mg/d EPA + DHA (Fish Oil) Supplement|
637671|NCT01078922|B1|Baseline|Ofatumumab|The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
637672|NCT01078922|P1|Participant Flow|Ofatumumab|Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
637673|NCT01078922|O1|Outcome|Ofatumumab|"The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours."
637674|NCT01078922|O1|Outcome|Ofatumumab|Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
637675|NCT01078922|E1|Reported Event|Ofatumumab|"The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours."
637676|NCT01078974|B1|Baseline|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day
Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
pomalidomide: Taken orally once a day
dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
637677|NCT01078974|P1|Participant Flow|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day
Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
pomalidomide: Taken orally once a day
dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
637678|NCT01078974|O1|Outcome|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day
Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
pomalidomide: Taken orally once a day
dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
637679|NCT01078974|O1|Outcome|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day
Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
pomalidomide: Taken orally once a day
dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
637680|NCT01078974|E1|Reported Event|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day
Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
pomalidomide: Taken orally once a day
dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
637681|NCT01091103|B1|Baseline|Enzalutamide|
637682|NCT01091103|P1|Participant Flow|Enzalutamide|
637683|NCT01091103|O1|Outcome|Enzalutamide|
637684|NCT01091103|O1|Outcome|Enzalutamide|
637685|NCT01091103|O1|Outcome|Enzalutamide|
637686|NCT01091103|O1|Outcome|Enzalutamide|
637687|NCT01091103|O1|Outcome|Enzalutamide|
637688|NCT01091103|O1|Outcome|Enzalutamide|
637689|NCT01091103|O1|Outcome|Enzalutamide|
637690|NCT01091103|O1|Outcome|Enzalutamide|
637691|NCT01091103|O1|Outcome|Enzalutamide|
637692|NCT01091103|O1|Outcome|Enzalutamide|
637693|NCT01091103|O2|Outcome|Enzalutamide, PSA Non-Responders at Week 9|PSA non-responders are defined by a less than 50% reduction from baseline in PSA at Week 9
637694|NCT01091103|O1|Outcome|Enzalutamide, PSA Responders at Week 9|PSA responders are defined by a greater than or equal to 50% reduction from baseline in PSA at Week 9
637695|NCT01091103|O2|Outcome|Enzalutamide, PSA Non-Responders at Week 9|PSA non-responders are defined by a less than 50% reduction from baseline in PSA at Week 9
637696|NCT01091103|O1|Outcome|Enzalutamide, PSA Responders at Week 9|PSA responders are defined by a greater than or equal to 50% reduction from baseline in PSA at Week 9
637697|NCT01091103|O1|Outcome|Enzalutamide|
637698|NCT01091103|O1|Outcome|Enzalutamide|
637699|NCT01091103|O1|Outcome|Enzalutamide|
637700|NCT01091103|E1|Reported Event|Enzalutamide|
637701|NCT01091116|B6|Baseline|Total|Total of all reporting groups
637702|NCT01091116|B5|Baseline|Placebo|two doses
637703|NCT01091116|B4|Baseline|Single High Dose|one dose+placebo
637704|NCT01091116|B3|Baseline|High Dose|two doses
637708|NCT01091116|P4|Participant Flow|Single High Dose|one intra-articular fasitibant dose 0.5 mg +placebo
637709|NCT01091116|P3|Participant Flow|High Dose|two intra-articular fasitibant doses; 0.5 mg each
637710|NCT01091116|P2|Participant Flow|Mid Dose|two intra-articular fasitibant doses; 0.25 mg each
637711|NCT01091116|P1|Participant Flow|Low Dose|two intra-articular fasitibant doses; 0.125 mg each
637712|NCT01091116|O5|Outcome|Placebo|two doses
637713|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
637714|NCT01091116|O3|Outcome|High Dose|two doses
637715|NCT01091116|O2|Outcome|Mid Dose|two doses
637716|NCT01091116|O1|Outcome|Low Dose|two doses
637717|NCT01091116|O5|Outcome|Placebo|two doses
637718|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
637719|NCT01091116|O3|Outcome|High Dose|two doses
637720|NCT01091116|O2|Outcome|Mid Dose|two doses
637721|NCT01091116|O1|Outcome|Low Dose|two doses
637722|NCT01091116|O5|Outcome|Placebo|two doses
637723|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
637724|NCT01091116|O3|Outcome|High Dose|two doses
637725|NCT01091116|O2|Outcome|Mid Dose|two doses
637726|NCT01091116|O1|Outcome|Low Dose|two doses
637727|NCT01091116|O5|Outcome|Placebo|two doses
637728|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
637729|NCT01091116|O3|Outcome|High Dose|two doses
637730|NCT01091116|O2|Outcome|Mid Dose|two doses
637731|NCT01091116|O1|Outcome|Low Dose|two doses
637732|NCT01091116|O5|Outcome|Placebo|two doses
637733|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
637734|NCT01091116|O3|Outcome|High Dose|two doses
637735|NCT01091116|O2|Outcome|Mid Dose|two doses
637736|NCT01091116|O1|Outcome|Low Dose|two doses
637737|NCT01091116|O5|Outcome|Placebo|two doses
637738|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
637739|NCT01091116|O3|Outcome|High Dose|two doses
637740|NCT01091116|O2|Outcome|Mid Dose|two doses
637741|NCT01091116|O1|Outcome|Low Dose|two doses
637742|NCT01091116|O5|Outcome|Placebo|two doses
637743|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
637744|NCT01091116|O3|Outcome|High Dose|two doses
637745|NCT01091116|O2|Outcome|Mid Dose|two doses
637746|NCT01091116|O1|Outcome|Low Dose|two doses
637747|NCT01091116|O5|Outcome|Placebo|two doses
637748|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
637749|NCT01091116|O3|Outcome|High Dose|two doses
637750|NCT01091116|O2|Outcome|Mid Dose|two doses
637762|NCT01091155|B1|Baseline|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
637763|NCT01091155|P1|Participant Flow|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
637764|NCT01091155|O1|Outcome|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
637765|NCT01091155|E1|Reported Event|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
637766|NCT01091246|B4|Baseline|Total|Total of all reporting groups
637767|NCT01091246|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
637768|NCT01091246|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
637769|NCT01091246|B1|Baseline|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637770|NCT01091246|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
637771|NCT01091246|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
637772|NCT01091246|P1|Participant Flow|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637773|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637774|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637775|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637776|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637777|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637778|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637779|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637780|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637781|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637868|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
637782|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637783|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637784|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637785|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637786|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637787|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637788|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637789|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637885|NCT01093651|B1|Baseline|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Placebo : Daily placebo for 4 months"
637955|NCT01093976|E1|Reported Event|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
637790|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637791|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637792|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637793|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
637794|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637795|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
637796|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637797|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637869|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
637798|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637799|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637800|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637801|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
637802|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637803|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
637804|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637805|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637806|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637807|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637808|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637809|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
637810|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637811|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
637812|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637813|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637814|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637815|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
637816|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637817|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
637818|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637819|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637820|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637821|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637822|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637823|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
637824|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637825|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
637826|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637827|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637828|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637829|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637830|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637831|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
637832|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637833|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
637834|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637835|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637836|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637837|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637838|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637839|NCT01091246|O4|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637840|NCT01091246|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
637841|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
637842|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637843|NCT01091246|E2|Reported Event|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
637844|NCT01091246|E1|Reported Event|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
637845|NCT01091259|B1|Baseline|Irinotecan With Bevacizumab|"Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
Irinotecan
Bevacizumab"
638086|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
637846|NCT01091259|P1|Participant Flow|Irinotecan With Bevacizumab|"Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
Irinotecan
Bevacizumab"
637847|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
637848|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
637849|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
637850|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
637851|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
637852|NCT01091259|E1|Reported Event|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
637853|NCT01093599|B3|Baseline|Total|Total of all reporting groups
637854|NCT01093599|B2|Baseline|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.
Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
637855|NCT01093599|B1|Baseline|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
637956|NCT01094119|B3|Baseline|Total|Total of all reporting groups
637856|NCT01093599|P2|Participant Flow|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.
Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
637857|NCT01093599|P1|Participant Flow|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
637858|NCT01093599|O2|Outcome|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.
Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
637859|NCT01093599|O1|Outcome|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
637860|NCT01093599|E2|Reported Event|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.
Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
637861|NCT01093599|E1|Reported Event|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
637862|NCT01093625|B3|Baseline|Total|Total of all reporting groups
637863|NCT01093625|B2|Baseline|Spectacles|Subjects are randomized to this Control Group.
637864|NCT01093625|B1|Baseline|Investigational Silicone Hydrogel Contact Lens|Subjects randomized to the study arm wearing contact lenses. These subjects are considered neophytes and are non-habitual wearers. Test Group.
637865|NCT01093625|P2|Participant Flow|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
637866|NCT01093625|P1|Participant Flow|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
637867|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
644047|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
637870|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
637871|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
637872|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
637873|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
637874|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
637875|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
637876|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
637877|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
637878|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
637879|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
637880|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
637881|NCT01093625|E2|Reported Event|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
637882|NCT01093625|E1|Reported Event|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
637883|NCT01093651|B3|Baseline|Total|Total of all reporting groups
637884|NCT01093651|B2|Baseline|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months"
637954|NCT01093976|O1|Outcome|Dronabinol|Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
637886|NCT01093651|P2|Participant Flow|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months"
637887|NCT01093651|P1|Participant Flow|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Placebo : Daily placebo for 4 months"
637888|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months"
637889|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Placebo : Daily placebo for 4 months"
637890|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months"
637891|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Placebo : Daily placebo for 4 months"
637892|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months"
637893|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Placebo : Daily placebo for 4 months"
637894|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months"
637895|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Placebo : Daily placebo for 4 months"
637896|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months"
637897|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Placebo : Daily placebo for 4 months"
637898|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months"
637899|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Placebo : Daily placebo for 4 months"
637900|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months"
637901|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Placebo : Daily placebo for 4 months"
637902|NCT01093651|E2|Reported Event|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months"
637903|NCT01093651|E1|Reported Event|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.
Placebo : Daily placebo for 4 months"
637904|NCT01093690|B3|Baseline|Total|Total of all reporting groups
637905|NCT01093690|B2|Baseline|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
637906|NCT01093690|B1|Baseline|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
637907|NCT01093690|P2|Participant Flow|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
637908|NCT01093690|P1|Participant Flow|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
637909|NCT01093690|O2|Outcome|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
637910|NCT01093690|O1|Outcome|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
637911|NCT01093690|E2|Reported Event|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
637912|NCT01093690|E1|Reported Event|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
637913|NCT01093755|B3|Baseline|Total|Total of all reporting groups
637914|NCT01093755|B2|Baseline|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.
Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
637915|NCT01093755|B1|Baseline|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months
dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
637916|NCT01093755|P2|Participant Flow|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.
Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
637917|NCT01093755|P1|Participant Flow|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months
dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
637918|NCT01093755|O2|Outcome|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.
Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
637919|NCT01093755|O1|Outcome|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months
dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
637920|NCT01093755|O2|Outcome|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.
Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
637921|NCT01093755|O1|Outcome|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months
dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
637922|NCT01093755|E2|Reported Event|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.
Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
637923|NCT01093755|E1|Reported Event|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months
dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
637924|NCT01093794|B1|Baseline|All Participants|
637925|NCT01093794|P4|Participant Flow|4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
sitagliptin/metformin 50 mg/850 mg FDC tablet
Co-administration of 50 mg sitagliptin and 500 mg metformin
Co-administration of 50 mg sitagliptin and 850 mg metformin
sitagliptin/metformin 50 mg/500 mg FDC tablet"
637926|NCT01093794|P3|Participant Flow|3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
Co-administration of 50 mg sitagliptin and 850 mg metformin
sitagliptin/metformin 50 mg/850 mg FDC tablet
sitagliptin/metformin 50 mg/500 mg FDC tablet
Co-administration of 50 mg sitagliptin and 500mg metformin"
637927|NCT01093794|P2|Participant Flow|2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
sitagliptin/metformin 50 mg/500 mg FDC tablet
Co-administration of 50 mg sitagliptin and 850 mg metformin
Co-administration of 50 mg sitagliptin and 500mg metformin
sitagliptin/metformin 50 mg/850 mg FDC tablet"
637928|NCT01093794|P1|Participant Flow|1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
Co-administration of 50 mg sitagliptin and 500 mg metformin
sitagliptin/metformin 50 mg/500 mg FDC tablet
sitagliptin/metformin 50 mg/850 mg FDC tablet
Co-administration of 50 mg sitagliptin and 850 mg metformin"
637929|NCT01093794|O4|Outcome|SitMet 50mg/850mg FDC|Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.
638087|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
637930|NCT01093794|O3|Outcome|Sit 50 mg + Met 850 mg|Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.
637931|NCT01093794|O2|Outcome|SitMet 50mg/500mg FDC|Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.
637932|NCT01093794|O1|Outcome|Sit 50 mg + Met 500 mg|Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.
637933|NCT01093794|O4|Outcome|SitMet 50mg/850mg FDC|Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.
637934|NCT01093794|O3|Outcome|Sit 50 mg + Met 850 mg|Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.
637935|NCT01093794|O2|Outcome|SitMet 50mg/500mg FDC|Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.
637936|NCT01093794|O1|Outcome|Sit 50 mg + Met 500 mg|Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.
637937|NCT01093794|E4|Reported Event|Sit/Met 50 mg/850 mg FDC|AEs reported in participants after administration of sitagliptin 50 mg/metformin 850 mg FDC tablet.
637938|NCT01093794|E3|Reported Event|Sit 50 mg + Met 850 mg|AEs reported in participants after co-administration of 50 mg sitagliptin and 850 mg metformin.
637939|NCT01093794|E2|Reported Event|Sit/Met 50 mg/500 mg FDC|AEs reported in participants after administration of the sitagliptin/metformin 50 mg/500 mg fixed dose combination (FDC) tablet.
637940|NCT01093794|E1|Reported Event|Sit 50 mg + Met 500 mg|AEs reported in participants after co-administration of 50 mg sitagliptin and 500 mg metformin.
637941|NCT01093846|B4|Baseline|Total|Total of all reporting groups
637942|NCT01093846|B3|Baseline|AIN457 Placebo|
637943|NCT01093846|B2|Baseline|AIN457 300 mg Monthly|300 mg monthly
637944|NCT01093846|B1|Baseline|AIN457 300 mg Every 2 Weeks|300 mg every two weeks
637945|NCT01093846|P3|Participant Flow|AIN457 Placebo|
637946|NCT01093846|P2|Participant Flow|AIN457 300 mg Monthly|300 mg monthly
637947|NCT01093846|P1|Participant Flow|AIN457 300 mg Every 2 Weeks|300 mg every two weeks
637948|NCT01093846|O1|Outcome|Early Termination|
637949|NCT01093846|E3|Reported Event|Placebo|Placebo Safety is provided over the entire treatment period. This includes the core and extension period.
637950|NCT01093846|E2|Reported Event|AIN457 300mg Monthly|AIN457 300mg monthly Safety is provided over the entire treatment period. This includes the core and extension period.
637951|NCT01093846|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300mg every 2 weeks. Safety is provided over the entire treatment period. This includes the core and extension period.
637952|NCT01093976|B1|Baseline|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
637953|NCT01093976|P1|Participant Flow|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
644931|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
637957|NCT01094119|B2|Baseline|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .
heated pad: patients will be warmed with a heated pad during surgery."
637958|NCT01094119|B1|Baseline|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.
heated blanket: heated blanket"
637959|NCT01094119|P2|Participant Flow|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .
heated pad: patients will be warmed with a heated pad during surgery."
637960|NCT01094119|P1|Participant Flow|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.
heated blanket: heated blanket"
637961|NCT01094119|O2|Outcome|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .
heated pad: patients will be warmed with a heated pad during surgery."
637962|NCT01094119|O1|Outcome|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.
heated blanket: heated blanket"
637963|NCT01094119|O2|Outcome|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .
heated pad: patients will be warmed with a heated pad during surgery."
637964|NCT01094119|O1|Outcome|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.
heated blanket: heated blanket"
637965|NCT01094119|E2|Reported Event|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .
heated pad: patients will be warmed with a heated pad during surgery."
637966|NCT01094119|E1|Reported Event|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.
heated blanket: heated blanket"
637967|NCT01094171|B1|Baseline|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
637968|NCT01094171|P1|Participant Flow|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
637969|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
637970|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
637971|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
637972|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
638088|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
637973|NCT01094171|E1|Reported Event|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
637974|NCT01094522|B3|Baseline|Total|Total of all reporting groups
637975|NCT01094522|B2|Baseline|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
637976|NCT01094522|B1|Baseline|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
637977|NCT01094522|P2|Participant Flow|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
637978|NCT01094522|P1|Participant Flow|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
637979|NCT01094522|O1|Outcome|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
638010|NCT01094561|O1|Outcome|Synthetic Human Secretin|"Single arm (open label).
Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
637980|NCT01094522|O2|Outcome|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
637981|NCT01094522|O1|Outcome|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
637982|NCT01094522|O2|Outcome|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
637983|NCT01094522|O1|Outcome|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
637984|NCT01094522|O1|Outcome|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
637985|NCT01094522|E2|Reported Event|Morphine|"One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
638089|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicone hydrogel contact lens.
638090|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicone hydrogel contact lens.
637986|NCT01094522|E1|Reported Event|Methadone|"One half the Study patients will be randomized to receive a loading dose of IV methadone, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.
Methadone: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
637987|NCT01094548|B3|Baseline|Total|Total of all reporting groups
637988|NCT01094548|B2|Baseline|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
637989|NCT01094548|B1|Baseline|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
637990|NCT01094548|P2|Participant Flow|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
637991|NCT01094548|P1|Participant Flow|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
637992|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
637993|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
637994|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
637995|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
638091|NCT01094730|E1|Reported Event|All Subjects|All subjects were to wear both lenses during the course of the study.
639120|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
637996|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
637997|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
637998|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
637999|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
638011|NCT01094561|O1|Outcome|Synthetic Human Secretin|"Single arm (open label).
Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
638012|NCT01094561|E1|Reported Event|Synthetic Human Secretin|"Single arm (open label).
Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
638013|NCT01094574|B7|Baseline|Total|Total of all reporting groups
638000|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
638001|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
638002|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg/m^2) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
638003|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
638004|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration in Weeks 1 and 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
638005|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
638006|NCT01094548|E2|Reported Event|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
638007|NCT01094548|E1|Reported Event|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
638008|NCT01094561|B1|Baseline|Synthetic Human Secretin|"Single arm (open label).
Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
638009|NCT01094561|P1|Participant Flow|Synthetic Human Secretin|"Single arm (open label).
Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
638217|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
638014|NCT01094574|B6|Baseline|Placebo -Alfentanil - Propanolol|Participants were randomized to receive an intravenous infusion of normal saline, alfentanil, and propanolol on 3 consecutive study days.
638015|NCT01094574|B5|Baseline|Propranolol - Alfentanil - Placebo|Participants were randomized to receive an intravenous infusion of propanolol, alfentanil, and normal saline on 3 consecutive study days.
638016|NCT01094574|B4|Baseline|Alfentanil - Propanolol - Placebo|Participants were randomized to receive an intravenous infusion of alfentanil, propanolol, and normal saline on 3 consecutive study days.
638017|NCT01094574|B3|Baseline|Placebo - Propanolol - Alfentanil|Participants were randomized to receive an intravenous infusion of normal saline, propanolol, and alfentanil on 3 consecutive study days.
638018|NCT01094574|B2|Baseline|Propranolol - Placebo - Alfentanil|Participants were randomized to receive an intravenous infusion of propanolol, normal saline, and alfentanil on 3 consecutive study days.
638019|NCT01094574|B1|Baseline|Alfentanil - Placebo - Propanolol|Participant(s) were randomized to receive an intravenous infusion of alfentanil, normal saline, and propanolol on 3 consecutive study days.
638020|NCT01094574|P6|Participant Flow|Placebo Day 1, Alfentanil Day 2, and Propranolol Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.
Day 2: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.
Day 3: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.
On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.
Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.
Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.
Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
638021|NCT01094574|P5|Participant Flow|Propranolol Day 1, Alfentanil Day 2, and Placebo Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.
Day 2: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.
Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.
On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.
Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.
Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.
Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
638022|NCT01094574|P4|Participant Flow|Alfentanil Day 1, Propranolol Day 2, and Palcebo Day 3|"Day 1: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.
Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.
Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.
On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.
Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.
Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.
Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
638023|NCT01094574|P3|Participant Flow|Placebo Day 1, Propranolol Day 2, and Alfentanil Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.
Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.
Day 3: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.
On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.
Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.
Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.
Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
638024|NCT01094574|P2|Participant Flow|Propranolol Day 1, Placebo Day 2, and Alfentanil Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.
Day 2: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.
Day 3: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.
On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.
Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.
Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.
Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
638025|NCT01094574|P1|Participant Flow|Alfentanil Day 1, Placebo Day 2, and Propranolol Day 3|"Day 1: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.
Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.
Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.
On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.
Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.
Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.
Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
638026|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
644932|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
638027|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638028|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638029|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638030|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638031|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638032|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638033|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638034|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638035|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638036|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638092|NCT01094743|B1|Baseline|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
638037|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638038|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638039|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638040|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638041|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638042|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638043|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638044|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638045|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638046|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638047|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638048|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638049|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638050|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638115|NCT01094808|P1|Participant Flow|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
644933|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
638051|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638052|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638053|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638054|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638055|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638056|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638057|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638058|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638059|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638060|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638061|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638062|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638063|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638064|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
638065|NCT01094574|E6|Reported Event|Placebo -Alfentanil - Propanolol|"An infusion of normal saline was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of alfentanil 100ng/ml was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of propranolol 30ng/ml was administered over 3 hours on study day 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
638066|NCT01094574|E5|Reported Event|Propranolol - Alfentanil - Placebo|"An infusion of propranolol 30ng/ml was administered over 3 hours on study day 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of alfentanil 100ng/ml was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of normal saline was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
638067|NCT01094574|E4|Reported Event|Alfentanil - Propanolol - Placebo|"An infusion of alfentanil 100ng/ml was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of propranolol 30ng/ml was administered over 3 hours on study day 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of normal saline was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
638068|NCT01094574|E3|Reported Event|Placebo - Propanolol - Alfentanil|"An infusion of normal saline was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of propranolol 30ng/ml was administered over 3 hours on study day 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of alfentanil 100ng/ml was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
638069|NCT01094574|E2|Reported Event|Propranolol - Placebo - Alfentanil|"An infusion of propranolol 30ng/ml was administered over 3 hours on study day 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of normal saline was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of alfentanil 100ng/ml was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
638116|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638117|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638118|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638070|NCT01094574|E1|Reported Event|Alfentanil - Placebo - Propanolol|"An infusion of alfentanil 100ng/ml was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of normal saline was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.
An infusion of propranolol 30ng/ml was administered over 3 hours on study day 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
638071|NCT01094704|B3|Baseline|Total|Total of all reporting groups
638072|NCT01094704|B2|Baseline|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
638073|NCT01094704|B1|Baseline|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
638074|NCT01094704|P2|Participant Flow|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
638075|NCT01094704|P1|Participant Flow|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
638076|NCT01094704|O2|Outcome|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
638077|NCT01094704|O1|Outcome|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
638078|NCT01094704|E2|Reported Event|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
638079|NCT01094704|E1|Reported Event|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
638080|NCT01094730|B1|Baseline|All Subjects|All enrolled subjects who have the demographic data and worn at least one study lens.
638081|NCT01094730|P2|Participant Flow|Marketed Galyfilcon A/Galyfilcon A Prototype|The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period.
638082|NCT01094730|P1|Participant Flow|Galyfilcon A Prototype/Marketed Galyfilcon A|The galyfilcon A prototype lens worn daily for 12-16 days during the first period then marketed galyfilcon A lens worn daily for 12-16 days during the second period.
638083|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
638084|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
638085|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
638093|NCT01094743|P1|Participant Flow|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
638094|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
638095|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
638096|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
638097|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
638098|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
638099|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
638100|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
638101|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
638102|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
638103|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
638104|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
638105|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
638106|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
638107|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
638108|NCT01094743|E1|Reported Event|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
638109|NCT01094808|B4|Baseline|Total|Total of all reporting groups
638110|NCT01094808|B3|Baseline|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638111|NCT01094808|B2|Baseline|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638112|NCT01094808|B1|Baseline|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638113|NCT01094808|P3|Participant Flow|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638114|NCT01094808|P2|Participant Flow|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638119|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638120|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638121|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638122|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638123|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638124|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638125|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638126|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638127|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638128|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638129|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638130|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638131|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638132|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638133|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638134|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638135|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638136|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638137|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638138|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638139|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638140|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638141|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638142|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638143|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638144|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638145|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638146|NCT01094808|E3|Reported Event|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
638147|NCT01094808|E2|Reported Event|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
638148|NCT01094808|E1|Reported Event|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
638149|NCT01094886|B1|Baseline|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
638150|NCT01094886|P1|Participant Flow|Rivaroxaban|10 mg PO (orally) qd (once daily) for up to 35 days for total hip replacement (THR) and 14 days for total knee replacement (TKR)
638151|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
638152|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
638153|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
638154|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
638155|NCT01094886|E1|Reported Event|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
638156|NCT01095094|B1|Baseline|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
ritonavir : Given orally
lopinavir : Given orally"
638157|NCT01095094|P1|Participant Flow|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
ritonavir : Given orally
lopinavir : Given orally"
638158|NCT01095094|O1|Outcome|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
ritonavir : Given orally
lopinavir : Given orally"
638159|NCT01095094|O1|Outcome|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
ritonavir : Given orally
lopinavir : Given orally"
638160|NCT01095094|E1|Reported Event|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
ritonavir : Given orally
lopinavir : Given orally"
638161|NCT01095250|B5|Baseline|Total|Total of all reporting groups
638162|NCT01095250|B4|Baseline|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
638163|NCT01095250|B3|Baseline|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
638164|NCT01095250|B2|Baseline|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
638165|NCT01095250|B1|Baseline|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
638166|NCT01095250|P4|Participant Flow|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
638167|NCT01095250|P3|Participant Flow|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg subcutaneously at baseline and Week 2, then every 4 weeks.
638168|NCT01095250|P2|Participant Flow|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
638169|NCT01095250|P1|Participant Flow|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
638170|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
638171|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
638172|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
638173|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
638174|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
638175|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
638176|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
638177|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
638178|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
638179|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
638180|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
638181|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
638182|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
638183|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
638184|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
638185|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
638186|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
638187|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
638188|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
638189|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
638190|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
638191|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
638192|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
638193|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
638194|NCT01095250|E4|Reported Event|Placebo Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
638195|NCT01095250|E3|Reported Event|AIN457 150mg Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
644048|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
638196|NCT01095250|E2|Reported Event|AIN457 300mg Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
638197|NCT01095250|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks
638198|NCT01095497|B3|Baseline|Total|Total of all reporting groups
638199|NCT01095497|B2|Baseline|IV CINRYZE First, Then SC CINRYZE Dose 2|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
638200|NCT01095497|B1|Baseline|IV CINRYZE First, Then SC CINRYZE Dose 1|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of SC CINRYZE twice weekly for two weeks.
638201|NCT01095497|P2|Participant Flow|IV CINRYZE First, Then SC CINRYZE Dose 2|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
638202|NCT01095497|P1|Participant Flow|IV CINRYZE First, Then SC CINRYZE Dose 1|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of intravenous (IV) CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of subcutaneous (SC) CINRYZE twice weekly for two weeks.
638203|NCT01095497|O3|Outcome|SC CINRYZE Dose 2|2000 Units of SC CINRYZE twice weekly for two weeks
638204|NCT01095497|O2|Outcome|SC CINRYZE Dose 1|1000 Units of SC CINRYZE twice weekly for two weeks
638205|NCT01095497|O1|Outcome|IV CINRYZE|1000 Units of IV CINRYZE twice weekly for two weeks
638206|NCT01095497|E3|Reported Event|SC CINRYZE Dose 2|2000 Units of SC CINRYZE twice weekly for two weeks
638207|NCT01095497|E2|Reported Event|SC CINRYZE Dose 1|1000 Units of SC CINRYZE twice weekly for two weeks
638208|NCT01095497|E1|Reported Event|IV CINRYZE|1000 Units of IV CINRYZE twice weekly for two weeks
638209|NCT01095510|B4|Baseline|Total|Total of all reporting groups
638210|NCT01095510|B3|Baseline|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
638211|NCT01095510|B2|Baseline|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
638212|NCT01095510|B1|Baseline|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
638213|NCT01095510|P4|Participant Flow|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
638214|NCT01095510|P3|Participant Flow|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
638215|NCT01095510|P2|Participant Flow|1000 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
638216|NCT01095510|P1|Participant Flow|500 U CINRYZE (10-25 kg Body Weight)|Single intravenous (IV) dose of 500 U CINRYZE
638218|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
638219|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
638220|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
638221|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
638222|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
638223|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
638224|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
638225|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
638226|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
638227|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
638228|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
638229|NCT01095510|E3|Reported Event|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
638230|NCT01095510|E2|Reported Event|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
638231|NCT01095510|E1|Reported Event|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
638232|NCT01095653|B4|Baseline|Total|Total of all reporting groups
638233|NCT01095653|B3|Baseline|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638234|NCT01095653|B2|Baseline|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638235|NCT01095653|B1|Baseline|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638236|NCT01095653|P3|Participant Flow|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638237|NCT01095653|P2|Participant Flow|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638238|NCT01095653|P1|Participant Flow|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638239|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638240|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638241|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638242|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638243|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638356|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
638244|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638245|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638246|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638247|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638248|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638249|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638250|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638251|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638252|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638253|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638254|NCT01095653|E3|Reported Event|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638255|NCT01095653|E2|Reported Event|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638256|NCT01095653|E1|Reported Event|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
638257|NCT01095757|B1|Baseline|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
638258|NCT01095757|P1|Participant Flow|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and granulocyte-colony stimulating factor (G-CSF).
Plerixafor : 240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target cluster of differentiation 34 (CD34) cell dose has been reached."
638259|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
638260|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
638261|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
638262|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
638263|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
638264|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
638265|NCT01095757|E1|Reported Event|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
638266|NCT01095796|B3|Baseline|Total|Total of all reporting groups
638267|NCT01095796|B2|Baseline|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
638268|NCT01095796|B1|Baseline|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
638269|NCT01095796|P2|Participant Flow|Atripla|Atripla® (efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
638270|NCT01095796|P1|Participant Flow|Stribild|Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regimen (STR) once daily plus placebo to match Atripla once daily prior to bedtime
638271|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
638272|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
638273|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
638274|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
638275|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
638276|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
638277|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
638278|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
638279|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
638280|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
638281|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
638282|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
638283|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
638284|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
638285|NCT01095796|E2|Reported Event|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
638286|NCT01095796|E1|Reported Event|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
638287|NCT01095835|B4|Baseline|Total|Total of all reporting groups
638288|NCT01095835|B3|Baseline|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638289|NCT01095835|B2|Baseline|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
638290|NCT01095835|B1|Baseline|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638291|NCT01095835|P3|Participant Flow|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
639154|NCT01098812|O1|Outcome|Control IOL|Approved Intraocular control lens
638292|NCT01095835|P2|Participant Flow|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
638293|NCT01095835|P1|Participant Flow|PEG-IFN48|Treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638294|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638295|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
638296|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638297|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638298|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
638299|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638300|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638301|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
644049|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
638302|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638303|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638304|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
638305|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638306|NCT01095835|O1|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638307|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638308|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
638309|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638310|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638497|NCT01081886|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
638311|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
638312|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638313|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638314|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
638315|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638316|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638317|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
638318|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638319|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638320|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
644050|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
638321|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638322|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638323|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
638324|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638325|NCT01095835|E3|Reported Event|PEG-IFN + LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
638326|NCT01095835|E2|Reported Event|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
638327|NCT01095835|E1|Reported Event|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
638328|NCT01095887|B1|Baseline|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
638329|NCT01095887|P1|Participant Flow|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
638330|NCT01095887|O1|Outcome|Eculizumab|Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
644934|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
638331|NCT01095887|E1|Reported Event|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
638332|NCT01095978|B1|Baseline|Klacid SR|The per-protocol population (2800 participants) with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
638333|NCT01095978|P1|Participant Flow|Klacid SR|Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
638334|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
638335|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
638336|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
638337|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
638338|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
638339|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
638340|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
638341|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
638342|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
638343|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
638344|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
638345|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
638346|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
638347|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
638348|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
638349|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
638350|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
638351|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
638352|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
638353|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
638354|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
638355|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
644051|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
638357|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
638358|NCT01095978|E1|Reported Event|Klacid SR|Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
638359|NCT01096017|B1|Baseline|All Study Participants|
638360|NCT01096017|P2|Participant Flow|Terbutaline First, Then Salbutamol|Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒Salbutamol pMDI 200 μg +placebo Turbuhaler®
638361|NCT01096017|P1|Participant Flow|Salbutamol First, Then Terbutaline|Salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
638362|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638363|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638364|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638365|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638366|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638367|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638368|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638369|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638370|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638371|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638372|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638373|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638374|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638375|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638376|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638377|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638378|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638379|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638380|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638381|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638382|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638383|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638384|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
638385|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
638386|NCT01096017|E2|Reported Event|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose.
638387|NCT01096017|E1|Reported Event|Salbutamol pMDI|200 μg, inhalation, single dose.
638388|NCT01096056|B3|Baseline|Total|Total of all reporting groups
639224|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
638389|NCT01096056|B2|Baseline|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638390|NCT01096056|B1|Baseline|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638391|NCT01096056|P2|Participant Flow|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638392|NCT01096056|P1|Participant Flow|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638393|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638394|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638395|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638396|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638397|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638398|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638399|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638400|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638401|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638402|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638403|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638404|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638405|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638406|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638407|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638408|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638409|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638410|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638411|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638412|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638413|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638414|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638415|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638416|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638417|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638418|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638419|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638420|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638421|NCT01096056|E2|Reported Event|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
638422|NCT01096056|E1|Reported Event|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
638423|NCT01081873|B1|Baseline|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses. Age was available for 2,691 patients only; age was missing for 23 patients who were thus not included in the age results.
638424|NCT01081873|P1|Participant Flow|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638425|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638426|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638427|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638428|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638429|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638549|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638430|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants - MRI|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via MRI.
638431|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants - Echograph|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via an echograph (hyperechogenic zones).
638432|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants - Prostate Biopsy|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via a prostate biopsy.
638433|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants - Rectal Examination|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via rectal examination.
638434|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638435|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a tissue type recorded at Baseline.
638436|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638437|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638438|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638439|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638440|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Use at Any Visit|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had used any of the treatments at any visit.
638441|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
638498|NCT01081886|O1|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
638442|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
638443|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
638444|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
638445|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
638446|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
638447|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
638448|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
638449|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
638450|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
638451|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
638452|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
638453|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
638454|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
638455|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
638456|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
638457|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
638458|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
638459|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
638460|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
638461|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
638462|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
638463|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
638464|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
638465|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
638466|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
638467|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
639155|NCT01098812|E2|Reported Event|All Toric IOLs|Investigational Toric IOLs including high cylinder powers
638468|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
638469|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
638470|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
638471|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
638472|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
638473|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
638474|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
638475|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
638476|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
638477|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
638478|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
638479|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
638480|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
638481|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
638482|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
638483|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
638484|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
638485|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
638486|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
638487|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
638488|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
638489|NCT01081873|E1|Reported Event|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
638490|NCT01081886|B3|Baseline|Total|Total of all reporting groups
638491|NCT01081886|B2|Baseline|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
638492|NCT01081886|B1|Baseline|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
638493|NCT01081886|P2|Participant Flow|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
638494|NCT01081886|P1|Participant Flow|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
638495|NCT01081886|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
638496|NCT01081886|O1|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
639156|NCT01098812|E1|Reported Event|ZCB00|Approved Intraocular control lens
638499|NCT01081886|E2|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
638500|NCT01081886|E1|Reported Event|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
638501|NCT01081912|B1|Baseline|Open-label Conversion/Titration Phase|Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label)
638502|NCT01081912|P3|Participant Flow|Double-Blind Treatment Phase: Placebo Comparator|"Placebo: Capsules, no active substance, shells identical to active comparator capsules.
Placebo capsules twice daily for up to 12 weeks (Double-Blind Period)"
638503|NCT01081912|P2|Participant Flow|Double-Blind Treatment Phase|"Treatment Phase: Hydrocodone Bitartrate Controlled-Release Capsules twice daily up to 12 weeks (Double-Blind Period)
Hydrocodone bitartrate: dosage form: capsule
Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
638504|NCT01081912|P1|Participant Flow|Conversion/Titration Phase - Open-Label|Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label Period)
638505|NCT01081912|O2|Outcome|Placebo Comparator|Placebo: Capsules, no active substance, shells identical to active comparator capsules
638506|NCT01081912|O1|Outcome|Hydrocodone Bitartrate Capsules|"Hydrocodone Bitartrate Controlled-Release Capsules
Hydrocodone bitartrate: dosage form: capsule
Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
638507|NCT01081912|E3|Reported Event|Double Blind Treatment Phase: Placebo Comparator|"Placebo: Capsules, no active substance, shells identical to active comparator capsules.
Placebo capsules twice daily for up to 12 weeks (Double-Blind Period)"
638508|NCT01081912|E2|Reported Event|Double Blind Treatment Phase: Hydrocodone Bitartrate Capsules|"Hydrocodone Bitartrate Controlled-Release Capsules twice daily up to 12 weeks (Double-Blind Period)
Hydrocodone bitartrate: dosage form: capsule
Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
638509|NCT01081912|E1|Reported Event|Open-Label Conversion/Titration Phase|Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label Period)
638510|NCT01081951|B3|Baseline|Total|Total of all reporting groups
638511|NCT01081951|B2|Baseline|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.
Followed by a post-completion phase in which no study treatment was administered"
638512|NCT01081951|B1|Baseline|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.
Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
638513|NCT01081951|P2|Participant Flow|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.
Followed by a post-completion phase in which no study treatment was administered"
638514|NCT01081951|P1|Participant Flow|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.
Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
638515|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.
Followed by a post-completion phase in which no study treatment was administered"
638516|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.
Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
638517|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.
Followed by a post-completion phase in which no study treatment was administered"
638518|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.
Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
638519|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.
Followed by a post-completion phase in which no study treatment was administered"
638520|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.
Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
638521|NCT01081951|E2|Reported Event|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.
Followed by a post-completion phase in which no study treatment was administered"
638522|NCT01081951|E1|Reported Event|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.
Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
638523|NCT01082081|B4|Baseline|Total|Total of all reporting groups
638524|NCT01082081|B3|Baseline|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638525|NCT01082081|B2|Baseline|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638526|NCT01082081|B1|Baseline|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638527|NCT01082081|P3|Participant Flow|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638528|NCT01082081|P2|Participant Flow|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638529|NCT01082081|P1|Participant Flow|Paracetamol Caplet 1000 Milligrams (mg)|Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (total dose= 1000 mg), with 150 milliliter (mL) of water through oral route.
638530|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638531|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638532|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638533|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638534|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638535|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638536|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638537|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638538|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638539|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638540|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638541|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638542|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638543|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638544|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638545|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638546|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638547|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638548|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
644052|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
638550|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638551|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638552|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638553|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638554|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638555|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638556|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638557|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638558|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638559|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638560|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638561|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638562|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638563|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638564|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638565|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638566|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638567|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638568|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638569|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638570|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638571|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638572|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638573|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638574|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638575|NCT01082081|E3|Reported Event|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
638576|NCT01082081|E2|Reported Event|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
638577|NCT01082081|E1|Reported Event|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
638578|NCT01082159|B1|Baseline|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
638579|NCT01082159|P1|Participant Flow|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
638580|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
638581|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous lumbar decompression using the mild Device Kit.
638582|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
638583|NCT01082159|E1|Reported Event|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
638584|NCT01082211|B1|Baseline|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
638585|NCT01082211|P1|Participant Flow|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
638586|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
638587|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
638588|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
638589|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
638636|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638590|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
638591|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
638592|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
638593|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
638594|NCT01082211|E1|Reported Event|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
638595|NCT01082328|B1|Baseline|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
638596|NCT01082328|P1|Participant Flow|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
638597|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
638598|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
638599|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
638600|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
638601|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
638602|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
638603|NCT01082328|E1|Reported Event|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
638604|NCT01082367|B3|Baseline|Total|Total of all reporting groups
638605|NCT01082367|B2|Baseline|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
638660|NCT01087905|B3|Baseline|2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
638832|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638606|NCT01082367|B1|Baseline|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
638607|NCT01082367|P2|Participant Flow|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
638608|NCT01082367|P1|Participant Flow|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
638609|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
638637|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638610|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
638611|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
638612|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
638613|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
638661|NCT01087905|B2|Baseline|2 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
639080|NCT01098578|O2|Outcome|Endoscopic Surgery|The calculated minimal institutional cost if all the study patients had been treated with endoscopic surgery for posterior epistaxis
638614|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
638615|NCT01082367|E6|Reported Event|Off-treatment (Follow-up)|Off-treatment (follow-up)
638616|NCT01082367|E5|Reported Event|OL TOBI (Follow-up)|OL TOBI (follow-up)
638617|NCT01082367|E4|Reported Event|Off-treatment (Core)|Off-treatment (core)
638618|NCT01082367|E3|Reported Event|OL TOBI (Core)|OL TOBI (core)
638619|NCT01082367|E2|Reported Event|DB Placebo|DB Placebo
638620|NCT01082367|E1|Reported Event|DB TOBI|DB TOBI
638621|NCT01082380|B1|Baseline|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638622|NCT01082380|P1|Participant Flow|PF-02341066 250 mg|Single oral dose of PF-02341066 250 milligram (mg) containing 100 micro-curie (μCi) Carbon -14[14C].
638623|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638624|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638625|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638626|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638627|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638628|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638629|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638630|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638631|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638632|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638633|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638634|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638635|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638844|NCT01088438|B2|Baseline|Control|No intervention
638638|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638639|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638640|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638641|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638642|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638643|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638644|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638645|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638646|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638647|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638648|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638649|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638650|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638651|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638652|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638653|NCT01082380|E1|Reported Event|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
638654|NCT01087905|B9|Baseline|Total|Total of all reporting groups
638655|NCT01087905|B8|Baseline|6 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
638656|NCT01087905|B7|Baseline|6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
638657|NCT01087905|B6|Baseline|6 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
638658|NCT01087905|B5|Baseline|6 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
638659|NCT01087905|B4|Baseline|2 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
639157|NCT01098851|B3|Baseline|Total|Total of all reporting groups
638662|NCT01087905|B1|Baseline|2 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
638663|NCT01087905|P8|Participant Flow|6 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
638664|NCT01087905|P7|Participant Flow|6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
638665|NCT01087905|P6|Participant Flow|6 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
638666|NCT01087905|P5|Participant Flow|6 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
638667|NCT01087905|P4|Participant Flow|2 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
638668|NCT01087905|P3|Participant Flow|2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
638669|NCT01087905|P2|Participant Flow|2 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
638670|NCT01087905|P1|Participant Flow|2 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
638671|NCT01087905|O4|Outcome|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
638672|NCT01087905|O3|Outcome|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
638673|NCT01087905|O2|Outcome|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
638674|NCT01087905|O1|Outcome|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
638845|NCT01088438|B1|Baseline|Contextualization Workshop|A four-hour course on contextualization.
638675|NCT01087905|O4|Outcome|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
638676|NCT01087905|O3|Outcome|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
638677|NCT01087905|O2|Outcome|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
638678|NCT01087905|O1|Outcome|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
638679|NCT01087905|O6|Outcome|Standard Cessation Counseling Plus CMAC)|Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC). This intervention is considered to be the enhanced intervention in terms of cessation counseling; it will be compared to the standard cessation counseling intervention which consists of Standard Cessation Counseling only (no CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
638680|NCT01087905|O5|Outcome|Standard Cessation Counseling (No CMAC)|Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls. This intervention is considered to be the standard intervention in terms of cessation counseling; it will be compared to the enhanced cessation counseling intervention which consists of Standard Cessation Counseling plus Cognitive Medication Adherence Counseling (CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
638681|NCT01087905|O4|Outcome|NRT Combination Therapy (Nicotine Patch Plus Nicotine Gum)|Participants in this intervention group received Combination Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch plus Nicotine Gum. This intervention is considered to be the enhanced intervention in terms of type of NRT; it will be compared to the standard NRT type intervention which is NRT Monotherapy consisting of the Nicotine Patch Only. Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
638682|NCT01087905|O3|Outcome|NRT Monotherapy (Nicotine Patch Only)|Participants in this intervention group received a single Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch only. This intervention is considered to be the standard intervention in terms of type of NRT; it will be compared to the enhanced NRT type intervention which is combination NRT consisting of Nicotine Patch plus Nicotine Gum (Combo NRT). Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
638683|NCT01087905|O2|Outcome|Six Weeks of Nicotine Replacement Therapy (NRT)|Participants in this intervention group received a six-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the enhanced intervention in terms of duration of NRT; it will be compared to the standard NRT duration intervention which is two weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
639081|NCT01098578|O1|Outcome|FLOSEAL|Institutional cost of treating all study patients with Floseal for posterior epistaxis
638684|NCT01087905|O1|Outcome|Two Weeks of Nicotine Replacement Therapy (NRT)|Participants in this intervention group received a two-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the standard intervention in terms of duration of NRT; it will be compared to the enhanced NRT duration intervention which is six weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
638685|NCT01087905|E4|Reported Event|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
638686|NCT01087905|E3|Reported Event|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
638687|NCT01087905|E2|Reported Event|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
638688|NCT01087905|E1|Reported Event|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
638689|NCT01087918|B3|Baseline|Total|Total of all reporting groups
638690|NCT01087918|B2|Baseline|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
638691|NCT01087918|B1|Baseline|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
638692|NCT01087918|P2|Participant Flow|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
638693|NCT01087918|P1|Participant Flow|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
638694|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638695|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638696|NCT01087918|O2|Outcome|First Strength Training, Then RAGT|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638697|NCT01087918|O1|Outcome|First RAGT, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638698|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638699|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638700|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638701|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638702|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638703|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638704|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638705|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638706|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638707|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638708|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638709|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638710|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of strength training 4 times a week
638711|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week
638712|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638713|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638714|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638715|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
638716|NCT01087918|E2|Reported Event|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
638717|NCT01087918|E1|Reported Event|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
638718|NCT01087944|B1|Baseline|Overall|Participants received PEG-IFN alfa-2a 180 mcg SC once a week either AI or PFS for the first 3 weeks and then switched to the other method of injection for an additional 3 weeks. Participants also received ribavirin according to standard of care per the investigator’s judgment.
638719|NCT01087944|P2|Participant Flow|Sequence 2 (Pre-filled Syringe Then Auto-Injector)|Participants received PEG-IFN 180 mcg /0.5 mL subcutaneously once a week using pre-filled syringe from Week 1-3 in Treatment Period 1 and using autoinjector from Week 4-6 in Treatment Period 2.
638720|NCT01087944|P1|Participant Flow|Sequence 1 (Auto-Injector Then Pre-filled Syringe)|Participants received Peginterferon alfa-2a (PEG-IFN) 180 microgram (mcg) /0.5 milliliter (mL) subcutaneously once a week using autoinjector from Week 1-3 in Treatment Period 1 and using pre-filled syringe from Week 4-6 in Treatment Period 2.
638761|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638721|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638722|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638723|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638724|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638725|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638726|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638727|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638846|NCT01088438|P2|Participant Flow|Control|No intervention
638847|NCT01088438|P1|Participant Flow|Contextualization Workshop|A four-hour course on contextualization.
638848|NCT01088438|O2|Outcome|Control|No intervention
644053|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
638728|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638729|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638730|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638731|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638732|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638733|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638734|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638735|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638736|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638762|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638737|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638738|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638739|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638740|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638741|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638742|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638743|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638744|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638745|NCT01087944|E2|Reported Event|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
638746|NCT01087944|E1|Reported Event|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
638747|NCT01087957|B3|Baseline|Total|Total of all reporting groups
638748|NCT01087957|B2|Baseline|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638749|NCT01087957|B1|Baseline|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638750|NCT01087957|P2|Participant Flow|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638751|NCT01087957|P1|Participant Flow|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638752|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638753|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638754|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638755|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638756|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638757|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638758|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638759|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638760|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
639158|NCT01098851|B2|Baseline|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
638763|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638764|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638765|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638766|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638767|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638768|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638769|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638770|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638771|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638772|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638773|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638774|NCT01087957|E2|Reported Event|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638775|NCT01087957|E1|Reported Event|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
638849|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
638850|NCT01088438|O2|Outcome|Control|No intervention
638851|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
638852|NCT01088438|O2|Outcome|Control|No intervention
638776|NCT01087970|B1|Baseline|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
638777|NCT01087970|P1|Participant Flow|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 milligrams/square meter (mg/m²) administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin area under curve (AUC) 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
638778|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
638779|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
638780|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
638781|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
638782|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
638826|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
639082|NCT01098578|O1|Outcome|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
638783|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
638784|NCT01087970|E2|Reported Event|Cetuximab + Pemetrexed + Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
638785|NCT01087970|E1|Reported Event|Cetuximab + Pemetrexed + Carboplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
638786|NCT01087996|B3|Baseline|Total|Total of all reporting groups
638787|NCT01087996|B2|Baseline|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638853|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
638788|NCT01087996|B1|Baseline|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638789|NCT01087996|P2|Participant Flow|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638790|NCT01087996|P1|Participant Flow|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638791|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638792|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638793|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638827|NCT01088399|O3|Outcome|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638828|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638829|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
638794|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638795|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638796|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638854|NCT01088438|E2|Reported Event|Control|No intervention
638855|NCT01088438|E1|Reported Event|Contextualization Workshop|A four-hour course on contextualization.
638856|NCT01088464|B4|Baseline|Total|Total of all reporting groups
638927|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638797|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638798|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638799|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638800|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638801|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638802|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638803|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638830|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638831|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
638804|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638805|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638806|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638807|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638808|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638809|NCT01087996|E2|Reported Event|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638810|NCT01087996|E1|Reported Event|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
638811|NCT01088295|B1|Baseline|Telmisartan|Telmisartan 40mg po daily for 24 weeks
638812|NCT01088295|P1|Participant Flow|Telmisartan|Telmisartan 40mg po daily for 24 weeks
638813|NCT01088295|O1|Outcome|Telmisartan|Telmisartan 40mg po daily for 24 weeks
638814|NCT01088295|E1|Reported Event|Telmisartan|
638815|NCT01088399|B4|Baseline|Total|Total of all reporting groups
638816|NCT01088399|B3|Baseline|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638817|NCT01088399|B2|Baseline|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638818|NCT01088399|B1|Baseline|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
638819|NCT01088399|P3|Participant Flow||It is not known whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638820|NCT01088399|P2|Participant Flow|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638821|NCT01088399|P1|Participant Flow|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
638822|NCT01088399|O3|Outcome|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638823|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638824|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
638825|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
644935|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
638833|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
638834|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638835|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
638836|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638837|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
638838|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638839|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
638840|NCT01088399|E3|Reported Event||It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638841|NCT01088399|E2|Reported Event|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
638842|NCT01088399|E1|Reported Event|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
638843|NCT01088438|B3|Baseline|Total|Total of all reporting groups
638857|NCT01088464|B3|Baseline|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638858|NCT01088464|B2|Baseline|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638859|NCT01088464|B1|Baseline|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638860|NCT01088464|P3|Participant Flow|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638861|NCT01088464|P2|Participant Flow|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638862|NCT01088464|P1|Participant Flow|Cohort 1: Necitumumab|Necitumumab 600 milligrams (mg) administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638863|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638864|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638865|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638866|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638867|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638868|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638869|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638870|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638871|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638872|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638873|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638874|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638875|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638876|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638877|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638878|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638879|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638880|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638881|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638882|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638883|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638884|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638885|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638886|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638887|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638888|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638889|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638890|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638891|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638892|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638893|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638894|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638895|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638896|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638897|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638898|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638899|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638900|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
644054|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
638901|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638902|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638903|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638904|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638905|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638906|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638907|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638908|NCT01088464|E3|Reported Event|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638909|NCT01088464|E2|Reported Event|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638910|NCT01088464|E1|Reported Event|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
638911|NCT01088503|B4|Baseline|Total|Total of all reporting groups
638912|NCT01088503|B3|Baseline|Ticlopidine/Ticagrelor|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
638913|NCT01088503|B2|Baseline|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
639083|NCT01098578|O1|Outcome|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
638914|NCT01088503|B1|Baseline|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638915|NCT01088503|P3|Participant Flow|Ticlopidine/Ticagrelor|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
638916|NCT01088503|P2|Participant Flow|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638917|NCT01088503|P1|Participant Flow|Prasugrel|Participants who were admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI) and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638918|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
638919|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638920|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
638921|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638922|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638923|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638924|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638925|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638926|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638928|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638929|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638930|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638931|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638932|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
638933|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638934|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638935|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638936|NCT01088503|E1|Reported Event|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
638937|NCT01088529|B3|Baseline|Total|Total of all reporting groups
638938|NCT01088529|B2|Baseline|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
638939|NCT01088529|B1|Baseline|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
638940|NCT01088529|P2|Participant Flow|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
638941|NCT01088529|P1|Participant Flow|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
638942|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
639084|NCT01098578|E1|Reported Event|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
639085|NCT01098747|B5|Baseline|Total|Total of all reporting groups
638943|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
638944|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
638945|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
638946|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
638947|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
638948|NCT01088529|E2|Reported Event|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
638949|NCT01088529|E1|Reported Event|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
638950|NCT01096186|B1|Baseline|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
638951|NCT01096186|P1|Participant Flow|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
638952|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
638953|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
638954|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
638955|NCT01096186|E1|Reported Event|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
638956|NCT01096316|B3|Baseline|Total|Total of all reporting groups
638957|NCT01096316|B2|Baseline|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
640016|NCT01093014|B1|Baseline|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
638958|NCT01096316|B1|Baseline|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:
enhanced education of patients and providers
engagement of patients
depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.
Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
638959|NCT01096316|P2|Participant Flow|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
638960|NCT01096316|P1|Participant Flow|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:
enhanced education of patients and providers
engagement of patients
depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.
Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
638961|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
638962|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:
enhanced education of patients and providers
engagement of patients
depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.
Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
639086|NCT01098747|B4|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
638963|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
638964|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:
enhanced education of patients and providers
engagement of patients
depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.
Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
638965|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
638966|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:
enhanced education of patients and providers
engagement of patients
depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.
Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
638967|NCT01096316|E2|Reported Event|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
639113|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639114|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
638968|NCT01096316|E1|Reported Event|Intervention|"The intervention will integrate care between a depression care manager(DCM), consulting study team (psychiatry OB-GYN physician) and OB-GYN clinic providers.
Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). The DCM in a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the 12-month intervention. Patients choose either medication or Problem-Solving Treatment. Depressive symptoms are assessed at each visit with the PHQ-9. Patients with inadequate response after 4 to 8 weeks to the first choice will switch or combine treatments. DCMs partcipate in weekly caseload review with a psychiatrist and Ob-Gyn physician who make treatment recommendations that the DCM then communicates to the patient's own Ob-Gyn physician who writes all prescriptions."
638969|NCT01096342|B1|Baseline|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
638970|NCT01096342|P1|Participant Flow|Phase II: 50 mg/m^2|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
638971|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
638972|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
638973|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
638974|NCT01096342|E1|Reported Event|Phase II: 50 mg/m^2|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
638975|NCT01098461|B5|Baseline|Total|Total of all reporting groups
638976|NCT01098461|B4|Baseline|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638977|NCT01098461|B3|Baseline|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638978|NCT01098461|B2|Baseline|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638979|NCT01098461|B1|Baseline|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638980|NCT01098461|P4|Participant Flow|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638981|NCT01098461|P3|Participant Flow|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638982|NCT01098461|P2|Participant Flow|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638983|NCT01098461|P1|Participant Flow|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638984|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638985|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638986|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638987|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
640281|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
638988|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638989|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638990|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638991|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638992|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638993|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638994|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638995|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638996|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638997|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638998|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
638999|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639087|NCT01098747|B3|Baseline|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
639000|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639001|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639002|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639003|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639004|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639005|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639006|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639007|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639008|NCT01098461|E4|Reported Event|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639009|NCT01098461|E3|Reported Event|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639010|NCT01098461|E2|Reported Event|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639011|NCT01098461|E1|Reported Event|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
639012|NCT01098487|B1|Baseline|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639013|NCT01098487|P1|Participant Flow|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639014|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639015|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639016|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639017|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639088|NCT01098747|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639089|NCT01098747|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets.
639018|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639019|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639020|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639021|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639022|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639023|NCT01098487|E1|Reported Event|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
639421|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
639024|NCT01098500|B1|Baseline|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639025|NCT01098500|P1|Participant Flow|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639026|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639027|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639028|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639029|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639030|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639031|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639115|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639116|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639032|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639033|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639034|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639035|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639036|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639090|NCT01098747|P4|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
639091|NCT01098747|P3|Participant Flow|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
639037|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639038|NCT01098500|E1|Reported Event|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
639039|NCT01098539|B3|Baseline|Total|Total of all reporting groups
639040|NCT01098539|B2|Baseline|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639041|NCT01098539|B1|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639042|NCT01098539|P2|Participant Flow|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639043|NCT01098539|P1|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639044|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639045|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639046|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639047|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639048|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639049|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639050|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639117|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639118|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639119|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639051|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639052|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639053|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639054|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639055|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639056|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639057|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639092|NCT01098747|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639093|NCT01098747|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets.
639094|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639058|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639059|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639060|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639061|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639062|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639063|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639064|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639065|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639066|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639067|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639095|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639096|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639097|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639068|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639069|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639070|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639071|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639072|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639073|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639074|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639075|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639076|NCT01098539|E2|Reported Event|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639077|NCT01098539|E1|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
639078|NCT01098578|B1|Baseline|Floseal|"Received Floseal treatment for posterior epistaxis.
Floseal : Received Floseal as treatment for posterior epistaxis."
639079|NCT01098578|P1|Participant Flow|Floseal.|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion.
639152|NCT01098812|O3|Outcome|Higher Cylinder Toric IOL|Investigational Toric IOLs with higher cylinder powers.
639098|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639099|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639100|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639101|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639102|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639103|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639104|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639105|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639106|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639107|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639108|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639109|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639110|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639111|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639112|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639121|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639122|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639123|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639124|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639125|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639126|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639127|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639128|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639129|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639130|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639131|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639132|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639133|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
639134|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639135|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639136|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639137|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
639138|NCT01098747|E4|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
639139|NCT01098747|E3|Reported Event|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
639140|NCT01098747|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
639141|NCT01098747|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets.
639142|NCT01098812|B4|Baseline|Total|Total of all reporting groups
639143|NCT01098812|B3|Baseline|Higher Cylinder Toric IOL|Investigational toric IOLs with higher cylinder powers.
639144|NCT01098812|B2|Baseline|Toric IOL|Investigational Toric IOL
639145|NCT01098812|B1|Baseline|ZCB00|Approved Intraocular control lens
639146|NCT01098812|P3|Participant Flow|Higher Cylinder Toric IOL|Investigational toric IOLs with higher cylinder powers.
639147|NCT01098812|P2|Participant Flow|Toric IOL|Investigational Toric IOL
639148|NCT01098812|P1|Participant Flow|ZCB00|Approved Intraocular control lens
639149|NCT01098812|O3|Outcome|Higher Cylinder Toric IOL|Investigational Toric IOLs with higher cylinder powers.
639150|NCT01098812|O2|Outcome|Toric IOL|Investigational Toric IOL
639151|NCT01098812|O1|Outcome|Control IOL|Approved Intraocular control lens
639159|NCT01098851|B1|Baseline|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
639160|NCT01098851|P2|Participant Flow|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
639161|NCT01098851|P1|Participant Flow|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
639162|NCT01098851|O2|Outcome|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
639163|NCT01098851|O1|Outcome|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
639164|NCT01098851|O2|Outcome|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
639165|NCT01098851|O1|Outcome|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
639166|NCT01098851|E2|Reported Event|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
639167|NCT01098851|E1|Reported Event|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
639168|NCT01099111|B6|Baseline|Total|Total of all reporting groups
639169|NCT01099111|B5|Baseline|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639170|NCT01099111|B4|Baseline|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639279|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion
Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
639171|NCT01099111|B3|Baseline|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639172|NCT01099111|B2|Baseline|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639173|NCT01099111|B1|Baseline|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639174|NCT01099111|P5|Participant Flow|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639175|NCT01099111|P4|Participant Flow|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639218|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639219|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639176|NCT01099111|P3|Participant Flow|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639177|NCT01099111|P2|Participant Flow|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639178|NCT01099111|P1|Participant Flow|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639422|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
640759|NCT01103414|B5|Baseline|Matching Placebo|Over-encapsulated placebo tablet
639179|NCT01099111|O5|Outcome|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639180|NCT01099111|O4|Outcome|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639181|NCT01099111|O3|Outcome|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639182|NCT01099111|O2|Outcome|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639183|NCT01099111|O1|Outcome|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639220|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639221|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639222|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639223|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639184|NCT01099111|E5|Reported Event|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639185|NCT01099111|E4|Reported Event|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639186|NCT01099111|E3|Reported Event|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639423|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
639187|NCT01099111|E2|Reported Event|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639188|NCT01099111|E1|Reported Event|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.
Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.
Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
639189|NCT01099202|B3|Baseline|Total|Total of all reporting groups
639190|NCT01099202|B2|Baseline|No Procrit|No intervention.
639191|NCT01099202|B1|Baseline|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
639192|NCT01099202|P2|Participant Flow|No Procrit|No intervention.
639193|NCT01099202|P1|Participant Flow|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
639194|NCT01099202|O2|Outcome|No Procrit|No intervention.
639195|NCT01099202|O1|Outcome|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
639196|NCT01099202|O2|Outcome|No Procrit|No intervention.
639197|NCT01099202|O1|Outcome|Procrit|Procrit starting dose 40,000 Units subcutaneously once a week with chemotherapy.
639198|NCT01099202|E2|Reported Event|No Procrit|No intervention.
639199|NCT01099202|E1|Reported Event|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
639200|NCT01099215|B3|Baseline|Total|Total of all reporting groups
639201|NCT01099215|B2|Baseline|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639202|NCT01099215|B1|Baseline|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639203|NCT01099215|P2|Participant Flow|High Dose PVS-10200 (Cohort B)|High dose PVS-10200 (15×10^5 cells/cm lesion)
639204|NCT01099215|P1|Participant Flow|Low Dose PVS-10200 (Cohort A)|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639205|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639206|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639207|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639208|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639209|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639210|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639211|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639212|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639213|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639214|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639215|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639216|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639217|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639225|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639226|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639227|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639228|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639229|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639230|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639231|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639232|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639233|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639234|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639235|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639236|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639237|NCT01099215|E2|Reported Event|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
639238|NCT01099215|E1|Reported Event|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
639239|NCT01099267|B1|Baseline|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
639281|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion
Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
639240|NCT01099267|P1|Participant Flow|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
639241|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
639242|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
639243|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
639244|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
639245|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
639246|NCT01099267|E1|Reported Event|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
639273|NCT01099397|E1|Reported Event|PEAR Sub-study Participants|All participants in the PEAR sub-study were evaluated by two methods at 3 time-points in the PEAR parent study
639274|NCT01099475|B3|Baseline|Total|Total of all reporting groups
639313|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
639965|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
639247|NCT01099358|B1|Baseline|All Participants (All Participants (Group A, B, C and D)|"A:Cycle1:100mg/m² cisplatin(cs) I.V on week(w)1,day(d)1. 5-FU as a 96-hour(h) C.I. of 1000 mg/m²/d starting (st) on w 1,d 1-4.
400mg/m² cetuximab(ct) I.V on w 2,d 1.250mg/m² ct I.V on w 3,d 1.Cycle 2+100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.250mg/m² ct I.V on w 1-3,d 1.
B:Cycle1:400mg/m² ct I.V on w 1,d 1.250mg/m² ct I.V on w 2&3,d 1.Cycle 2:100mg/m² cs I.V on w 1, d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1- 4.250mg/m² ct I.V on w 1-3,d 1.Cycle 3 +:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.
250mg/m² ct I.V on w 1-3,d 1. C:Cycle1:100mg/m² cs I.V on w 1, d 1. 5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1.400 mg/m² ct I.V on w 2,d 1.250mg/m² ct I.V on w 3&4,d 1.Cycle2-6:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1. 250mg/m² ct I.V w 1,2,&3,d 1.
D:Cycle1:400mg/m² ct I.V w 1,d 1.100mg/m² cs I.V w 1,d 1.Optional 5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1."
639248|NCT01099358|P4|Participant Flow|Cetuximab and Cisplatin (D)|"Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.
100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.
After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.
After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
639403|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
639404|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639405|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
639249|NCT01099358|P3|Participant Flow|Cetuximab and Cisplatin (C)|"Cycle 1 (4 weeks, combination therapy):
100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks combination therapy):
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.
After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.
Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
639250|NCT01099358|P2|Participant Flow|Cetuximab on Cisplatin (B)|"Cycle 1:
400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.
Cycle 2:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cycle 3 + :
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.
Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
639251|NCT01099358|P1|Participant Flow|Cisplatin on Cetuximab (A)|"Cycle 1:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.
Cycle 2 +:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.
Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
639252|NCT01099358|O1|Outcome|Cetuximab (D)|"Cetuximab and Cisplatin (D)
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.
100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1."
639253|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.
Cycle 2:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cycle 3 + :
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639254|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.
Cycle 2:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cycle 3 + :
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639275|NCT01099475|B2|Baseline|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion
Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
639474|NCT01100255|B2|Baseline|Group B|IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
639255|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)
Cycle 1:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.
Cycle 2 +:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.
Cetuximab and Cisplatin (C)
Cycle 1 (4 weeks, combination therapy):
100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks combination therapy):
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639280|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.
Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
639406|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
639424|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
639256|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)
Cycle 1:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.
Cycle 2 +:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.
Cetuximab and Cisplatin (C)
Cycle 1 (4 weeks, combination therapy):
100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks combination therapy):
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639257|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.
Cycle 2:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cycle 3 + :
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639258|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.
Cycle 2:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cycle 3 + :
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639259|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)
Cycle 1:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.
Cycle 2 +:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.
Cetuximab and Cisplatin (C)
Cycle 1 (4 weeks, combination therapy):
100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks combination therapy):
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639260|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)
Cycle 1:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.
Cycle 2 +:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.
Cetuximab and Cisplatin (C)
Cycle 1 (4 weeks, combination therapy):
100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks combination therapy):
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639261|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.
Cycle 2:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cycle 3 + :
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639276|NCT01099475|B1|Baseline|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.
Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
644936|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
639262|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.
Cycle 2:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cycle 3 + :
100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639263|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)
Cycle 1:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.
Cycle 2 +:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.
Cetuximab and Cisplatin (C)
Cycle 1 (4 weeks, combination therapy):
100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks combination therapy):
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639264|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)
Cycle 1:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.
Cycle 2 +:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.
Cetuximab and Cisplatin (C)
Cycle 1 (4 weeks, combination therapy):
100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks combination therapy):
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
639265|NCT01099358|E4|Reported Event|Cetuximab and Cisplatin (D)|"Cetuximab and Cisplatin (D)
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.
100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.
After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.
After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
639266|NCT01099358|E3|Reported Event|Cetuximab and Cisplatin (C)|"Cetuximab and Cisplatin (C)
Cycle 1 (4 weeks, combination therapy):
100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks combination therapy):
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.
After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.
Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
639267|NCT01099358|E2|Reported Event|Cetuximab on Cisplatin (B)|"Cetuximab on Cisplatin (B)
Cycle 1:
400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.
Cycle 2:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
Cycle 3 + :
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on week 1-3, day 1.
After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.
Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
639268|NCT01099358|E1|Reported Event|Cisplatin on Cetuximab (A)|"Cisplatin on Cetuximab (A)
Cycle 1:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.
Cycle 2 +:
100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.
250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.
After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.
Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
639269|NCT01099397|B1|Baseline|PEAR Sub-study Participants|All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study
639270|NCT01099397|P1|Participant Flow|PEAR Sub-study Participants|All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study; participants enrolled were evaluated at three time points as part of the PEAR protocol, at baseline, 9 weeks and 18 weeks; for each participant at each time point, a fasting glucose value and 2-hour oral glucose tolerance test value was collected and compared
639271|NCT01099397|O2|Outcome|Fasting Glucose|Fasting glucose collected
639272|NCT01099397|O1|Outcome|2-hour Glucose|Glucose collected after a 2 hour oral glucose tolerance test
644937|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
639277|NCT01099475|P2|Participant Flow|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion
Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
639278|NCT01099475|P1|Participant Flow|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.
Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
639282|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.
Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
639283|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion
Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
639284|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.
Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
639285|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion
Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
639286|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.
Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
639287|NCT01099475|E2|Reported Event|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion
Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
639288|NCT01099475|E1|Reported Event|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.
Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
639289|NCT01099579|B4|Baseline|Total|Total of all reporting groups
639290|NCT01099579|B3|Baseline|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 20 to 40 mg received ATV, 200 mg, with RTV, 100 mg, and those who weighed at least 40 kg received ATV, 300 mg, with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
639299|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639391|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
644938|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
639291|NCT01099579|B2|Baseline|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to 20 kg received ATV, 150 mg, with RTV, 100 mg, and those who weighed 20 to 40 mg received ATV, 200 mg with RTV,100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
639292|NCT01099579|B1|Baseline|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
639407|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639408|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
644055|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
639293|NCT01099579|P3|Participant Flow|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
639294|NCT01099579|P2|Participant Flow|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
639295|NCT01099579|P1|Participant Flow|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
639296|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639297|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639298|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639311|NCT01099579|O2|Outcome|ARV-naive|ARV treatment-naive participants were those with no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
639312|NCT01099579|O1|Outcome|ARV-experienced|Antiretroviral (ARV) treatment-experienced participants were those with previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
639300|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639301|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639409|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
639410|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639411|NCT01099761|E4|Reported Event|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
644056|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
639302|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639303|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639304|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639305|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639306|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639307|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639308|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639309|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639310|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639314|NCT01099579|O1|Outcome|ARV- Experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
639315|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639412|NCT01099761|E3|Reported Event|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639413|NCT01099761|E2|Reported Event|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
644057|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/CGC genetic make-up
639316|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639317|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639318|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
639319|NCT01099579|O1|Outcome|ARV- Experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
639320|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639321|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639322|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639323|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639324|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639325|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639392|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639393|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
639394|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
639395|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639326|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639414|NCT01099761|E1|Reported Event|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639415|NCT01099774|B3|Baseline|Total|Total of all reporting groups
639327|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639328|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639329|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639330|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639331|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639332|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
639333|NCT01099579|O1|Outcome|ARV-experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
639334|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639335|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639336|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639337|NCT01099579|O2|Outcome|ARV-naive|ARV treatment-naive participants were those with no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
639338|NCT01099579|O1|Outcome|ARV-experienced|Antiretroviral (ARV) treatment-experienced participants were those with previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
639396|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
639397|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
639339|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639340|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639341|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639342|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639343|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
639344|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
639345|NCT01099579|E3|Reported Event|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
639346|NCT01099579|E2|Reported Event|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 20 to 40 mg received ATV, 200 mg, with RTV, 100 mg, and those who weighed at least 40 kg received ATV, 300 mg, with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
639347|NCT01099579|E1|Reported Event|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to 20 kg received ATV, 150 mg, with RTV, 100 mg, and those who weighed 20 to 40 mg received ATV, 200 mg with RTV,100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
639348|NCT01099618|B4|Baseline|Total|Total of all reporting groups
639398|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639399|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
639475|NCT01100255|B1|Baseline|Group A|0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
639416|NCT01099774|B2|Baseline|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
639417|NCT01099774|B1|Baseline|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
639418|NCT01099774|P2|Participant Flow|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
639419|NCT01099774|P1|Participant Flow|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
639420|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
639349|NCT01099618|B3|Baseline|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639350|NCT01099618|B2|Baseline|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639351|NCT01099618|B1|Baseline|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639352|NCT01099618|P3|Participant Flow|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639353|NCT01099618|P2|Participant Flow|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639354|NCT01099618|P1|Participant Flow|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639355|NCT01099618|O3|Outcome|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639356|NCT01099618|O2|Outcome|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639357|NCT01099618|O1|Outcome|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639400|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
639401|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639402|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
639358|NCT01099618|E3|Reported Event|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639359|NCT01099618|E2|Reported Event|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639360|NCT01099618|E1|Reported Event|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).
metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
639361|NCT01099709|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
639362|NCT01099709|P2|Participant Flow|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
639363|NCT01099709|P1|Participant Flow|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
639364|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639365|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dosed administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639366|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639367|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639368|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639369|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639370|NCT01099709|E2|Reported Event|Original OxyContin® (OXY) 10-mg Tablet (Fed)|Original OxyContin® (OXY) 10-mg tablet (fed) x 1 dose
639371|NCT01099709|E1|Reported Event|Reformulated OXY 10-mg Tablet (Fed)|Reformulated OXY 10-mg tablet (fed) x 1 dose
639372|NCT01099761|B5|Baseline|Total|Total of all reporting groups
639373|NCT01099761|B4|Baseline|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
639374|NCT01099761|B3|Baseline|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639375|NCT01099761|B2|Baseline|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
639376|NCT01099761|B1|Baseline|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639377|NCT01099761|P4|Participant Flow|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
639378|NCT01099761|P3|Participant Flow|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639379|NCT01099761|P2|Participant Flow|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
639380|NCT01099761|P1|Participant Flow|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639381|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
639382|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
639383|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639384|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
639385|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
639386|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639387|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
639388|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
639389|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
639390|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
639966|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
639425|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
639426|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
639427|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
639428|NCT01099774|E2|Reported Event|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
639429|NCT01099774|E1|Reported Event|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
639430|NCT01099917|B1|Baseline|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
639431|NCT01099917|P1|Participant Flow|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
639432|NCT01099917|O1|Outcome|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
639433|NCT01099917|E1|Reported Event|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
639434|NCT01100073|B1|Baseline|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639435|NCT01100073|P1|Participant Flow|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use. The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639436|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639437|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639438|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639439|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639440|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639441|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639442|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639443|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639444|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639445|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639446|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639447|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639448|NCT01100073|E1|Reported Event|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
639449|NCT01100086|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
639450|NCT01100086|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.
639451|NCT01100086|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 10-mg tablet (test) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
639452|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
639453|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
639454|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
639455|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
639456|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
639457|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
639458|NCT01100086|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
639459|NCT01100086|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
639460|NCT01100112|B1|Baseline|Budesonide|"Budesonide-MMX 9 mg tablet
Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
639461|NCT01100112|P1|Participant Flow|Budesonide|"Budesonide-multi-matrix system (MMX) 9 mg tablet
Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
639462|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet
Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
639463|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet
Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
639464|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet
Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
639465|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet
Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
639466|NCT01100112|E1|Reported Event|Budesonide|"Budesonide-MMX 9 mg tablet
Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
639467|NCT01100242|B1|Baseline|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
639468|NCT01100242|P1|Participant Flow|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
639469|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
639470|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
639471|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
639472|NCT01100242|E1|Reported Event|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
639473|NCT01100255|B3|Baseline|Total|Total of all reporting groups
639476|NCT01100255|P2|Participant Flow|Group B|IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
639477|NCT01100255|P1|Participant Flow|Group A|0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
639478|NCT01100255|O2|Outcome|Ketamine Infusion|"0.5mg/kg IV infusion over 40 minutes
Ketamine infusion: 0.5mg/kg IV over 40 minutes"
639479|NCT01100255|O1|Outcome|Saline Infusion|"IV saline infusion over 40 minutes
Saline: saline infusion"
639480|NCT01100255|E2|Reported Event|Ketamine Infusion|0.5mg/kg IV ketamine infusion over 40 minutes
639481|NCT01100255|E1|Reported Event|Saline Infusion|IV saline infusion over 40 minutes
639482|NCT01100268|B1|Baseline|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
639483|NCT01100268|P1|Participant Flow|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
639484|NCT01100268|O1|Outcome|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
639485|NCT01100268|O1|Outcome|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
639486|NCT01100268|E1|Reported Event|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
639487|NCT01100307|B3|Baseline|Total|Total of all reporting groups
639488|NCT01100307|B2|Baseline|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639489|NCT01100307|B1|Baseline|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639490|NCT01100307|P2|Participant Flow|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
644058|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
639491|NCT01100307|P1|Participant Flow|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639492|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639493|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639494|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639495|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639496|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639497|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639498|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639499|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639500|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639770|NCT01091948|O1|Outcome|Active Comparator: Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
639501|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639502|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639503|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639504|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639505|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639506|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639507|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639571|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
640760|NCT01103414|B4|Baseline|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
639508|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639509|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639510|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639511|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639512|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639513|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639514|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639515|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639516|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639517|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639518|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639519|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639520|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639521|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639522|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639523|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639524|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639525|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639526|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639527|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639528|NCT01100307|E4|Reported Event|Sham Conversion (Week 24 to Week 54)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
639529|NCT01100307|E3|Reported Event|Pegaptanib Sodium (Baseline to Week 54)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
639530|NCT01100307|E2|Reported Event|Sham (Baseline to Week 24)|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication.
639531|NCT01100307|E1|Reported Event|Pegaptanib Sodium (Baseline to Week 24)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24).
639532|NCT01100320|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
639533|NCT01100320|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.
639534|NCT01100320|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
639535|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639536|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639537|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639538|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639539|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639540|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639541|NCT01100320|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639771|NCT01091948|E2|Reported Event|GlideScope® Video Laryngoscope|Subjects will be intubated with the GlideScope® Video Laryngoscope
639542|NCT01100320|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
639543|NCT01100437|B1|Baseline|Entire Study Population|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participant’s pain up to 35 days. The participants then started the Maintenance Phase and were administered the established stable dose of EMBEDA for a minimum of 7 days up to 28 days. Eligible participants were randomized into the 2 treatment groups.
639544|NCT01100437|P3|Participant Flow|EMBEDA Capsule|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administrated and titrated to a dose that adequately managed the participants pain for up to 35 days. In the Maintenance Phase the participant’s were administered the established stable dose for a minimum of 7 days up to 28 days. Participants were not randomized to treatment phase.
639545|NCT01100437|P2|Participant Flow|EMBEDA Solution Then EMBEDA Capsule|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participants were administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered crushed EMBEDA capsules orally at participants stable dose mixed in solution along with matched placebo capsules in the first intervention period. In the second intervention period the participant received whole EMBEDA capsules administered orally at participant’s stable dose along with matched placebo solution.
639572|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639573|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639546|NCT01100437|P1|Participant Flow|EMBEDA Capsule Then EMBEDA Solution|EMBEDA (morphine sulfate plus naltrexone hydrochloride) Extended Release (ER) capsule(s) were administered orally once or twice a day (20 milligrams [mg] to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participant was administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered whole EMBEDA capsules orally at participant’s stable dose along with a matched placebo solution in the first intervention period. In the second intervention period the participant received crushed EMBEDA capsules that were mixed in solution and administered orally at participant's stable dose along with matched placebo capsules.
639547|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639548|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639549|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639550|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639551|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639552|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639553|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639554|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639555|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639556|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639557|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639558|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639559|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639560|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639561|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639562|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639772|NCT01091948|E1|Reported Event|Fiberoptic|Subjects will be intubated with the Fiberoptic laryngoscope.
639563|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639564|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639565|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639566|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639567|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639568|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639569|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639570|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639744|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
639574|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639575|NCT01100437|O1|Outcome|EMBEDA Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639576|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
639577|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639578|NCT01100437|E4|Reported Event|EMBEDA Capsules Maintenance Period|EMBEDA capsule(s) administered orally once or twice a day dose (20 mg go 120 mg) at the participants stable dose for 7 days minimum.
639579|NCT01100437|E3|Reported Event|EMBEDA Capsule Titration/Stabilization Period|EMBEDA capsule(s) administered orally once or twice a day (20 mg go 120 mg) to adequately manage the participants pain.
639580|NCT01100437|E2|Reported Event|EMBEDA Crushed in Solution Treatment Period|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo whole capsules in any treatment period .
639581|NCT01100437|E1|Reported Event|EMBEDA Whole Capsule Treatment Period|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
639582|NCT01100502|B3|Baseline|Total|Total of all reporting groups
639583|NCT01100502|B2|Baseline|Placebo|placebo every 3 weeks by IV infusion
639584|NCT01100502|B1|Baseline|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
639585|NCT01100502|P2|Participant Flow|Placebo|placebo every 3 weeks by IV infusion
639586|NCT01100502|P1|Participant Flow|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
639587|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
639588|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
639589|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
639590|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
639591|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
639592|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
639593|NCT01100502|E2|Reported Event|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
639594|NCT01100502|E1|Reported Event|Placebo|placebo every 3 weeks by IV infusion
639595|NCT01100567|B3|Baseline|Total|Total of all reporting groups
639596|NCT01100567|B2|Baseline|Placebo|Randomized to sham platform 10 min daily
639597|NCT01100567|B1|Baseline|LMMS|Randomized to 10 min LMMS daily
639598|NCT01100567|P2|Participant Flow|Placebo|Randomized to sham platform 10 min daily
639599|NCT01100567|P1|Participant Flow|LMMS|Randomized to 10 min LMMS daily
639600|NCT01100567|O2|Outcome|Placebo|Randomized to sham platform 10 min daily
639601|NCT01100567|O1|Outcome|LMMS|Randomized to 10 min LMMS daily
639602|NCT01100567|O2|Outcome|Placebo|Randomized to sham platform 10 min daily
639603|NCT01100567|O1|Outcome|LMMS|Randomized to 10 min LMMS daily
639604|NCT01100567|E2|Reported Event|Placebo|Randomized to sham platform 10 min daily
639605|NCT01100567|E1|Reported Event|LMMS|Randomized to 10 min LMMS daily
639773|NCT01091974|B5|Baseline|Total|Total of all reporting groups
644939|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
639606|NCT01100606|B1|Baseline|Entire Study Population|Includes all enrolled participants who received EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple juice using a syringe nurser first and EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple sauce using a spoon first.
639607|NCT01100606|P2|Participant Flow|EUR-1008 (APT-1008) in Apple Sauce First, Then in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kg/day.
639608|NCT01100606|P1|Participant Flow|EUR-1008 (APT-1008) in Apple Juice First, Then in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kilogram body weight/day (lipase units/kg/day).
639609|NCT01100606|O1|Outcome|Entire Study Population|Includes all enrolled participants who received EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple juice using a syringe nurser first and EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple sauce using a spoon first.
639610|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsules) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily with dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639611|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsules) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily with dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
644059|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
639612|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639613|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639614|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639615|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639616|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639617|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639618|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639619|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639620|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639621|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639622|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639623|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639624|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639682|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639625|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639626|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639627|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639628|NCT01100606|E3|Reported Event|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639629|NCT01100606|E2|Reported Event|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
639630|NCT01100606|E1|Reported Event|Zenpep®|Zenpep® 5,000 from open capsule, mixed with a small amount of apple sauce, orally daily in the screening period for 10 days.
639631|NCT01100658|B1|Baseline|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
639632|NCT01100658|P1|Participant Flow|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
639633|NCT01100658|O1|Outcome|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
644060|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
639634|NCT01100658|O1|Outcome|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
639635|NCT01100658|E1|Reported Event|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
639636|NCT01100723|B1|Baseline|Post Treatment|Results analyzed at study evaluation time points.
639637|NCT01100723|P1|Participant Flow|Post Treatment|Patients had their mineral and bone disorders managed by the computer directed algorithm. Cinacalcet dose was increased starting at 30 mg/day as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.
639638|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
639639|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
639640|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
639641|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
639642|NCT01100723|O1|Outcome|Results Analyzed at Study Evaluation Time Points.|Results analyzed at study evaluation time points of 1 year and 6 months.
639643|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
639644|NCT01100723|E1|Reported Event|Post Treatment|Results analyzed at study evaluation time points.
639645|NCT01100762|B1|Baseline|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.
In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
639646|NCT01100762|P1|Participant Flow|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.
In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
639647|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
639648|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
639649|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
639650|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
639651|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
639652|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
639653|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
639654|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
639655|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
639656|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
639657|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
639658|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
639659|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
639660|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
639661|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
639745|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
639662|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
639663|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
639664|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
639665|NCT01100762|E1|Reported Event|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.
In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
639666|NCT01100853|B3|Baseline|Total|Total of all reporting groups
639667|NCT01100853|B2|Baseline|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639668|NCT01100853|B1|Baseline|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639669|NCT01100853|P2|Participant Flow|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639670|NCT01100853|P1|Participant Flow|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639671|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639672|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639673|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639674|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639675|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639676|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639677|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639678|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639679|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639680|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639681|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
644940|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
639683|NCT01100853|E2|Reported Event|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639684|NCT01100853|E1|Reported Event|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
639685|NCT01091454|B1|Baseline|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
639686|NCT01091454|P1|Participant Flow|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
639687|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
639688|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
639689|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
639690|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
639691|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
639692|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
639693|NCT01091454|E1|Reported Event|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
639694|NCT01091519|B3|Baseline|Total|Total of all reporting groups
639695|NCT01091519|B2|Baseline|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
639696|NCT01091519|B1|Baseline|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
639697|NCT01091519|P2|Participant Flow|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
639698|NCT01091519|P1|Participant Flow|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
639699|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
639700|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
639701|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
639702|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
639703|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
639731|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
639826|NCT01092442|O3|Outcome|Retrospective Right Ventricular Outflow Tract (RVOT)|
639704|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
639705|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
639706|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
639707|NCT01091519|E2|Reported Event|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
639708|NCT01091519|E1|Reported Event|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
639709|NCT01091662|B3|Baseline|Total|Total of all reporting groups
639710|NCT01091662|B2|Baseline|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepineacetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
639711|NCT01091662|B1|Baseline|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
639712|NCT01091662|P2|Participant Flow|ESL1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
639713|NCT01091662|P1|Participant Flow|ESL 1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
639714|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
639715|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
639716|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
639717|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
639718|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
639719|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
639720|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
639721|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
639722|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
639723|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
639724|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
639725|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
639726|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
639727|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
639728|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
639729|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
639730|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
639769|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
639732|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
639733|NCT01091662|O1|Outcome|ESL 1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
639734|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
639735|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
639736|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
639737|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
639738|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
639739|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
639740|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
639741|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
639742|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
639743|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
639746|NCT01091662|E2|Reported Event|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
639747|NCT01091662|E1|Reported Event|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
639748|NCT01091675|B1|Baseline|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.
Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
639749|NCT01091675|P1|Participant Flow|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.
Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
639750|NCT01091675|O1|Outcome|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.
Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
639751|NCT01091675|E1|Reported Event|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.
Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
639752|NCT01091948|B3|Baseline|Total|Total of all reporting groups
639753|NCT01091948|B2|Baseline|GlideScope® Video Laryngoscope|"Subjects will be intubated with the GlideScope® Video Laryngoscope.
GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope."
639754|NCT01091948|B1|Baseline|Fiberoptic Intubation|"Subjects will be intubated with the Fiberoptic laryngoscope.
Intubation with Fiberoptic laryngoscope: Subjects will be intubated with the Fiberoptic laryngoscope."
639755|NCT01091948|P2|Participant Flow|GlideScope® Video Laryngoscope|"Subjects will be intubated with the GlideScope® Video Laryngoscope.
GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope."
639756|NCT01091948|P1|Participant Flow|Active Comparator: Fiberoptic Intubation|"Subjects will be intubated with the Fiberoptic laryngoscope.
Active Comparator: GlideScope® Video Laryngoscope Subjects will be intubated with the GlideScope® Video Laryngoscope"
639757|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
639758|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
639759|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
639760|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
639761|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
639762|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
639763|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
639764|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
639765|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
639766|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
639767|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
639768|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
639774|NCT01091974|B4|Baseline|4 - Armodafinil Only|"Armodafinil only
armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)"
639775|NCT01091974|B3|Baseline|3 - Placebo Only|"Placebo only
Placebo Comparator: Placebo for 47 days"
639776|NCT01091974|B2|Baseline|2 - CBT-I + Armodafinil|"CBT-I + Armodafinil
armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
639777|NCT01091974|B1|Baseline|1 - CBT-I + Placebo|"CBT-I and placebo
Placebo Comparator: Placebo for 47 days
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
639778|NCT01091974|P4|Participant Flow|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
639779|NCT01091974|P3|Participant Flow|3- Placebo Only|Placebo Comparator: Placebo for 47 days
639780|NCT01091974|P2|Participant Flow|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
639781|NCT01091974|P1|Participant Flow|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
639782|NCT01091974|O4|Outcome|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
639783|NCT01091974|O3|Outcome|3- Placebo Only|Placebo Comparator: Placebo for 47 days
639784|NCT01091974|O2|Outcome|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
639785|NCT01091974|O1|Outcome|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
639786|NCT01091974|O4|Outcome|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
639787|NCT01091974|O3|Outcome|3- Placebo Only|Placebo Comparator: Placebo for 47 days
639788|NCT01091974|O2|Outcome|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
639875|NCT01092663|B3|Baseline|Total|Total of all reporting groups
639789|NCT01091974|O1|Outcome|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
639790|NCT01091974|E4|Reported Event|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
639791|NCT01091974|E3|Reported Event|3- Placebo Only|Placebo Comparator: Placebo for 47 days
639792|NCT01091974|E2|Reported Event|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
639793|NCT01091974|E1|Reported Event|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
639794|NCT01092338|B3|Baseline|Total|Total of all reporting groups
639795|NCT01092338|B2|Baseline|7000IU/d Vitamin D3|
639796|NCT01092338|B1|Baseline|4000IU/d of Vitamin D3|
639797|NCT01092338|P2|Participant Flow|7000IU/d Vitamin D3|
639798|NCT01092338|P1|Participant Flow|4000IU/d of Vitamin D3|
639799|NCT01092338|O2|Outcome|7000IU/d Vitamin D3|
639800|NCT01092338|O1|Outcome|4000IU/d of Vitamin D3|
639801|NCT01092338|O2|Outcome|7000IU/d Vitamin D3|
639802|NCT01092338|O1|Outcome|4000IU/d of Vitamin D3|
639803|NCT01092338|E2|Reported Event|7000IU/d Vitamin D3|
639804|NCT01092338|E1|Reported Event|4000IU/d of Vitamin D3|
639805|NCT01092416|B1|Baseline|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
639806|NCT01092416|P1|Participant Flow|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
639807|NCT01092416|O1|Outcome|OAS Treatment Group|Subjects enrolled in ORBIT II study and in whom the atherectomy device was inserted.
639808|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
639809|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study
639810|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study
639811|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
639812|NCT01092416|E2|Reported Event|ORBIT II Subjects - 1 Year Results|Serious Adverse Events reported from 31 Days to 1 Year Post-Procedure for Subjects enrolled in ORBIT II study.
639813|NCT01092416|E1|Reported Event|ORBIT II Subjects - 30 Day Results|Serious Adverse Events reported out to 30 Days Post-Procedure for Subjects enrolled in ORBIT II study.
639814|NCT01092442|B3|Baseline|Total|Total of all reporting groups
639815|NCT01092442|B2|Baseline|Prospective Patients|Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
639816|NCT01092442|B1|Baseline|Retrospective Patients|Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
639817|NCT01092442|P2|Participant Flow|Prospective Patients|Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
639818|NCT01092442|P1|Participant Flow|Retrospective Patients|Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
639819|NCT01092442|O2|Outcome|RVOT Reconstruction Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures
639820|NCT01092442|O1|Outcome|Ross Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure
639821|NCT01092442|O4|Outcome|Prospective RVOT|
639822|NCT01092442|O3|Outcome|Retrospective RVOT|
639823|NCT01092442|O2|Outcome|Prospective Ross|
639824|NCT01092442|O1|Outcome|Retrospective Ross|
639825|NCT01092442|O4|Outcome|Prospective RVOT|
639829|NCT01092442|E2|Reported Event|RVOT Reconstruction Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures
639830|NCT01092442|E1|Reported Event|Ross Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure
639831|NCT01092507|B3|Baseline|Total|Total of all reporting groups
639832|NCT01092507|B2|Baseline|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
639833|NCT01092507|B1|Baseline|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
639834|NCT01092507|P2|Participant Flow|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
639835|NCT01092507|P1|Participant Flow|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
639836|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
639837|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
639838|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
639839|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
639840|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
639841|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
639842|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
639843|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
639844|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
639845|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
639846|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
639847|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
639848|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
639849|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
639850|NCT01092507|E2|Reported Event|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
639851|NCT01092507|E1|Reported Event|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
639852|NCT01092546|B1|Baseline|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
639853|NCT01092546|P1|Participant Flow|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
639854|NCT01092546|O1|Outcome|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
639855|NCT01092546|O1|Outcome|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
639856|NCT01092546|E1|Reported Event|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
639857|NCT01092559|B1|Baseline|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide via GeNO Nitrosyl System
639858|NCT01092559|P1|Participant Flow|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
639859|NCT01092559|O1|Outcome|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
639860|NCT01092559|O1|Outcome|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
639861|NCT01092559|E1|Reported Event|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
639862|NCT01092637|B3|Baseline|Total|Total of all reporting groups
639863|NCT01092637|B2|Baseline|Non-cooled|Child was allocated standard intensive care only within 6 hours of birth
639864|NCT01092637|B1|Baseline|Cooled|Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth
639893|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639967|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
639865|NCT01092637|P2|Participant Flow|Non-cooled|"Child was allocated standard intensive care only within 6 hours of birth. Normothermia was maintained throughout.
Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study.
Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire.
Psychologist completed the following tests:
Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III)
NEPSY II selected sub-tests
Working Memory Test Battery for Children (WMTB-C)
Assessors were blinded to original trial treatment allocation."
639866|NCT01092637|P1|Participant Flow|Cooled|"Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth. Cooling lasted for 72 hours then gradually rewarmed, after which normothermia was maintained.
Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study.
Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire.
Psychologist completed the following tests:
Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III)
NEPSY II selected sub-tests
Working Memory Test Battery for Children (WMTB-C)
Assessors were blinded to original trial treatment allocation."
639867|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
639868|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
639869|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
639870|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
639871|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization to original trial. See full description in Participant flow section.
639872|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
639873|NCT01092637|E2|Reported Event|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
639874|NCT01092637|E1|Reported Event|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
639876|NCT01092663|B2|Baseline|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.
Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
639877|NCT01092663|B1|Baseline|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
639878|NCT01092663|P2|Participant Flow|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639879|NCT01092663|P1|Participant Flow|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639880|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639881|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639882|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639883|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639884|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639885|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639886|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639887|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639888|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639889|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639890|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639891|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639892|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639894|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639895|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639896|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639897|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639898|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639899|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639900|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639901|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639902|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639903|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639904|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
644061|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
639905|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639906|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639907|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639908|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
639909|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
639910|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.
Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
639911|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
639912|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.
Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
639913|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
639914|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.
Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
639915|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
639916|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
Sitagliptin: Subjects were given 100 mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks."
639917|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
639918|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.
Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
639919|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
639920|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks."
639921|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
639963|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
639964|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
639922|NCT01092663|E2|Reported Event|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.
Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
639923|NCT01092663|E1|Reported Event|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
639924|NCT01092702|B1|Baseline|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
639925|NCT01092702|P1|Participant Flow|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
639926|NCT01092702|O1|Outcome|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
639927|NCT01092702|E1|Reported Event|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
639928|NCT01092728|B3|Baseline|Total|Total of all reporting groups
639929|NCT01092728|B2|Baseline|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
639930|NCT01092728|B1|Baseline|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
639931|NCT01092728|P2|Participant Flow|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
639932|NCT01092728|P1|Participant Flow|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
639933|NCT01092728|O2|Outcome|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
639934|NCT01092728|O1|Outcome|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
639935|NCT01092728|O2|Outcome|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
640140|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
639936|NCT01092728|O1|Outcome|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
639937|NCT01092728|E2|Reported Event|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
639938|NCT01092728|E1|Reported Event|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
639939|NCT01092767|B1|Baseline|Valiant Thoracic Stent Graft With the Captivia Delivery System|
639940|NCT01092767|P1|Participant Flow|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
639941|NCT01092767|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
639942|NCT01092767|E1|Reported Event|1. Rescue|Rescue
639943|NCT01092780|B1|Baseline|All Randomized Participants|All participants who were randomized in the study.
639944|NCT01092780|P4|Participant Flow|Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg|Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
639945|NCT01092780|P3|Participant Flow|Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg|Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
639946|NCT01092780|P2|Participant Flow|MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo|Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
639947|NCT01092780|P1|Participant Flow|MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil|Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
639948|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
639949|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
639950|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
639951|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
639952|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
639953|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
639954|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
639955|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
639956|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
639957|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
639958|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
639959|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
639960|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
639961|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
639962|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
639968|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
639969|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
639970|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
639971|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
639972|NCT01092780|E4|Reported Event|Placebo|Participants received single doses of Placebo.
639973|NCT01092780|E3|Reported Event|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
639974|NCT01092780|E2|Reported Event|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
639975|NCT01092780|E1|Reported Event|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
639976|NCT01092832|B3|Baseline|Total|Total of all reporting groups
639977|NCT01092832|B2|Baseline|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639978|NCT01092832|B1|Baseline|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
640250|NCT01100944|O3|Outcome|All Participants|All participants who had at least one dose of belinostat.
639979|NCT01092832|P2|Participant Flow|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639980|NCT01092832|P1|Participant Flow|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) with invasive candidiasis/candidemia (ICC) received a loading dose of voriconazole 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with esophageal candidiasis (EC) received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to oral (PO) therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639981|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639982|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639983|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639996|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System
Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
639997|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System
Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
639984|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639985|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639986|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
640014|NCT01093014|B3|Baseline|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
639987|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639988|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639989|NCT01092832|E2|Reported Event|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639990|NCT01092832|E1|Reported Event|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
639991|NCT01092910|B1|Baseline|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
639992|NCT01092910|P1|Participant Flow|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System
Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
639993|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System
Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
639994|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System
Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
639995|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System
Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
640042|NCT01093027|O2|Outcome|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
640379|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
639998|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System
Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
639999|NCT01092910|O1|Outcome|Esteem Implant|"Subjects implanted with the Esteem Totally Implantable Hearing System
The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
640000|NCT01092910|E1|Reported Event|Esteem Implant|"Subjects implanted with the Esteem Totally Implantable Hearing System
Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
640001|NCT01092923|B3|Baseline|Total|Total of all reporting groups
640002|NCT01092923|B2|Baseline|Sevoflurane in N2O/O2|Sevoflurane in 2:1 N2O/O2
640003|NCT01092923|B1|Baseline|Air/Oxygen|Sevoflurane with Air/Oxygen Mix
640004|NCT01092923|P2|Participant Flow|Sevoflurane in N2O/O2|Sevoflurane in 2:1 N2O/O2
640005|NCT01092923|P1|Participant Flow|Air/Oxygen|Sevoflurane with Air/Oxygen Mix
640006|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|sevoflurane in air/O2 mix
640007|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|sevoflurane with N20 and Oxygen in 2:1 mix
640008|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|Air/Oxygen and Sevoflurane
640009|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|N20 with Oxygen (2:1) and Sevoflurane
640010|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|Air/Oxygen and Sevoflurane
640011|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|N20 with Oxygen (2:1) and Sevoflurane
640012|NCT01092923|E1|Reported Event|N20 With Oxygen (2:1)|sevoflurane with N20 and Oxygen in 2:1 mix
640013|NCT01093014|B4|Baseline|Total|Total of all reporting groups
640015|NCT01093014|B2|Baseline|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
640017|NCT01093014|P3|Participant Flow|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
640018|NCT01093014|P2|Participant Flow|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
640019|NCT01093014|P1|Participant Flow|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
640020|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
640021|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
640022|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
640023|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
640024|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
640025|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
640026|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
640027|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
640028|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
640029|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
640030|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
640031|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
640032|NCT01093014|E3|Reported Event|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
640033|NCT01093014|E2|Reported Event|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
640034|NCT01093014|E1|Reported Event|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
640035|NCT01093027|B3|Baseline|Total|Total of all reporting groups
640036|NCT01093027|B2|Baseline|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
640037|NCT01093027|B1|Baseline|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
640038|NCT01093027|P2|Participant Flow|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
640039|NCT01093027|P1|Participant Flow|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
640040|NCT01093027|O2|Outcome|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
640041|NCT01093027|O1|Outcome|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
640043|NCT01093027|O1|Outcome|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
640044|NCT01093027|E2|Reported Event|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
640045|NCT01093027|E1|Reported Event|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
640046|NCT01093222|B1|Baseline|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
640047|NCT01093222|P1|Participant Flow|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
640048|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
640049|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
640050|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
640051|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
640052|NCT01093222|E1|Reported Event|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
640053|NCT01093417|B3|Baseline|Total|Total of all reporting groups
644062|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
640054|NCT01093417|B2|Baseline|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
640055|NCT01093417|B1|Baseline|Placebo|15 participants were randomized to matching placebo for 12 weeks
640056|NCT01093417|P2|Participant Flow|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
640057|NCT01093417|P1|Participant Flow|Placebo|15 participants were randomized to matching placebo for 12 weeks
640058|NCT01093417|O2|Outcome|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
640059|NCT01093417|O1|Outcome|Placebo|15 participants were randomized to matching placebo for 12 weeks
640060|NCT01093417|O2|Outcome|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
640061|NCT01093417|O1|Outcome|Placebo|15 participants were randomized to matching placebo for 12 weeks
640062|NCT01093417|E2|Reported Event|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
640063|NCT01093417|E1|Reported Event|Placebo|15 participants were randomized to matching placebo for 12 weeks
640064|NCT01093469|B4|Baseline|Total|Total of all reporting groups
640065|NCT01093469|B3|Baseline|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
640066|NCT01093469|B2|Baseline|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
640067|NCT01093469|B1|Baseline|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
640068|NCT01093469|P3|Participant Flow|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
640069|NCT01093469|P2|Participant Flow|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
640070|NCT01093469|P1|Participant Flow|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
640071|NCT01093469|O3|Outcome|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
640072|NCT01093469|O2|Outcome|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
640073|NCT01093469|O1|Outcome|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
640074|NCT01093469|E3|Reported Event|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
640075|NCT01093469|E2|Reported Event|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
640076|NCT01093469|E1|Reported Event|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
640077|NCT01093521|B1|Baseline|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640078|NCT01093521|P1|Participant Flow|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640079|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640080|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640120|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640081|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640082|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640083|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640084|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640085|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640086|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640087|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640088|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640089|NCT01093521|O2|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day"
640090|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day"
640091|NCT01093521|E1|Reported Event|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion
IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
640092|NCT01093534|B4|Baseline|Total|Total of all reporting groups
640093|NCT01093534|B3|Baseline|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640094|NCT01093534|B2|Baseline|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640095|NCT01093534|B1|Baseline|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640096|NCT01093534|P3|Participant Flow|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640097|NCT01093534|P2|Participant Flow|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640098|NCT01093534|P1|Participant Flow|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640099|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640100|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640101|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640102|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640103|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640104|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640105|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640106|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640107|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640108|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640109|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640110|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640111|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640112|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640113|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640114|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640115|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640116|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640117|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640118|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640119|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640121|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640122|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640123|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640124|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640125|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640126|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640127|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640128|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640129|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640130|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640131|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640132|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640133|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640134|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640135|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640136|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640137|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640138|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640139|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640141|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640142|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640143|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640144|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640145|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640146|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640147|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640148|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640149|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640150|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640151|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640152|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640153|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640154|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640155|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640156|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640157|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640158|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640159|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640160|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640161|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640162|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640163|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640164|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640165|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640166|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640167|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640168|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640169|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640170|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640171|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640172|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
641752|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily
UT-15C: oral"
640173|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640174|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640175|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640176|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640177|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640178|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640179|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640180|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640181|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640182|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640183|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640184|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640185|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640186|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640187|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640188|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640189|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640190|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640191|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640192|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640193|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640194|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640195|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
640196|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640197|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640198|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640199|NCT01093534|E3|Reported Event|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
640200|NCT01093534|E2|Reported Event|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
640201|NCT01093534|E1|Reported Event|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
640202|NCT01100931|B3|Baseline|Total|Total of all reporting groups
640203|NCT01100931|B2|Baseline|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
640204|NCT01100931|B1|Baseline|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
640205|NCT01100931|P2|Participant Flow|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
640206|NCT01100931|P1|Participant Flow|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
640207|NCT01100931|O2|Outcome|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
640208|NCT01100931|O1|Outcome|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
640209|NCT01100931|O1|Outcome|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
640210|NCT01100931|O1|Outcome|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
640211|NCT01100931|E2|Reported Event|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
640263|NCT01101022|P2|Participant Flow|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640264|NCT01101022|P1|Participant Flow|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640212|NCT01100931|E1|Reported Event|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
640213|NCT01100944|B1|Baseline|All Participants|All participants who had at least one dose of Belinostat.
640214|NCT01100944|P3|Participant Flow|Belinostat and Chemotherapy at the Maximum Tolerated Dose(MTD)|Patients were treated with belinostat, doxorubicin, cisplatin and cyclophosphamide at the maximum tolerated dose derived from the phase I dose level.
640215|NCT01100944|P2|Participant Flow|Belinostat 500mg/m(2) and Chemotherapy|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640216|NCT01100944|P1|Participant Flow|Belinostat 250mg/m(2) and Chemotherapy|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640282|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640283|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640217|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640218|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640219|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640220|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640221|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640222|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640265|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640266|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640267|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640223|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640224|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640225|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640284|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640226|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640227|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640228|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640229|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640230|NCT01100944|O2|Outcome|Phase 1 Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640231|NCT01100944|O1|Outcome|Phase 1 Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640232|NCT01100944|O2|Outcome|Phase 1 Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640233|NCT01100944|O1|Outcome|Phase 1 Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640234|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640285|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640286|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640287|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640235|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640236|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640237|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat.
PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640238|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640239|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640240|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640268|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640269|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
644941|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
640241|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640251|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640242|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640243|NCT01100944|O1|Outcome|Phase I Dose Level 1 & Phase I Dose Level 2|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640244|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640245|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640246|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640247|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat.
PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640248|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640270|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640271|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
641753|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily
UT-15C: oral"
640249|NCT01100944|O1|Outcome|Thymic Particpants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640252|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD) and was utilized in the expansion phase (phase 2)."
640253|NCT01100944|O1|Outcome|All Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640254|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
640255|NCT01100944|O2|Outcome|Thymoma Participants|The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
640256|NCT01100944|O1|Outcome|Thymic Participants|The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
640257|NCT01100944|O1|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640258|NCT01100944|O1|Outcome|Phase I Dose Level 1 & Phase I Dose Level 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.
A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
640259|NCT01100944|E1|Reported Event|All Participants|All participants who had at least one dose of belinostat.
640260|NCT01101022|B3|Baseline|Total|Total of all reporting groups
640261|NCT01101022|B2|Baseline|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640262|NCT01101022|B1|Baseline|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640272|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640273|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640274|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640275|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640276|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640277|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640278|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640279|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640280|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
644063|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
640288|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640289|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640290|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640291|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640292|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640293|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640294|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640295|NCT01101022|E2|Reported Event|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
640296|NCT01101022|E1|Reported Event|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
640297|NCT01101165|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
640298|NCT01101165|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin(OXY)(Reference)in period 1 and Reformulated OXY (Test) in period 2.
640299|NCT01101165|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
640300|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640301|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640302|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640303|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640304|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640305|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640306|NCT01101165|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640307|NCT01101165|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640308|NCT01101178|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
640309|NCT01101178|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin(OXY)(Reference)in period 1 and Reformulated OXY (Test) in period 2.
640310|NCT01101178|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
640311|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
640312|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640313|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
640314|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640315|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
640316|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640317|NCT01101178|E3|Reported Event|Screening|
640318|NCT01101178|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
640319|NCT01101178|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
640320|NCT01101191|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
640321|NCT01101191|P2|Participant Flow|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
640322|NCT01101191|P1|Participant Flow|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
640323|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640324|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640325|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640326|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640327|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640328|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
640329|NCT01101191|E3|Reported Event|Prerandomization|
640330|NCT01101191|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
640331|NCT01101191|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
640332|NCT01101841|B3|Baseline|Total|Total of all reporting groups
640333|NCT01101841|B2|Baseline|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640334|NCT01101841|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental
Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
640335|NCT01101841|P2|Participant Flow|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640336|NCT01101841|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental
Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
640337|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640338|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640339|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640340|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640341|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640342|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640343|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640344|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640345|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640346|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640347|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640348|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640349|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640350|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640351|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640352|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640353|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640354|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640355|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640356|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640357|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640358|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640359|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640360|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640361|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640362|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either MesaBrisdelle (paroxetine mesylate) Capsules fem or placebo capsules in a 1:1 ratio.
640363|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640364|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640365|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640366|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640367|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640368|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640369|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640370|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640371|NCT01101841|E2|Reported Event|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
640372|NCT01101841|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental
Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
640373|NCT01101867|B3|Baseline|Total|Total of all reporting groups
640374|NCT01101867|B2|Baseline|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
640375|NCT01101867|B1|Baseline|Flexible Dose|aspart dose determined based upon carbohydrate intake.
640376|NCT01101867|P2|Participant Flow|Fixed Dose|Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.
640377|NCT01101867|P1|Participant Flow|Flexible Dose|Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).
640378|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
640380|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
640381|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
640382|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
640383|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
640384|NCT01101867|E2|Reported Event|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
640385|NCT01101867|E1|Reported Event|Flexible Dose|aspart dose determined based upon carbohydrate intake.
640386|NCT01101958|B3|Baseline|Total|Total of all reporting groups
640387|NCT01101958|B2|Baseline|Treatment Arm--CV Positive|This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
640388|NCT01101958|B1|Baseline|Treatment Arm--CV Negative|This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
640389|NCT01101958|P2|Participant Flow|Treatment Arm--CV Positive|This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
640390|NCT01101958|P1|Participant Flow|Treatment Arm--CV Negative|This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
640391|NCT01101958|O2|Outcome|Treatment Arm--CV Positive|This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
640392|NCT01101958|O1|Outcome|Treatment Arm--CV Negative|This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
640393|NCT01101958|E2|Reported Event|Treatment Arm--CV Positive|This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
640394|NCT01101958|E1|Reported Event|Treatment Arm--CV Negative|This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
644064|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
640395|NCT01101971|B1|Baseline|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
640396|NCT01101971|P1|Participant Flow|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
640397|NCT01101971|O1|Outcome|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
640398|NCT01101971|E1|Reported Event|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
640399|NCT01102140|B3|Baseline|Total|Total of all reporting groups
640400|NCT01102140|B2|Baseline|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.
Sugar Pill: Matching sugar pill"
640401|NCT01102140|B1|Baseline|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.
POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
640402|NCT01102140|P2|Participant Flow|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.
Sugar Pill: Matching sugar pill"
640403|NCT01102140|P1|Participant Flow|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.
POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
640404|NCT01102140|O2|Outcome|Control- Sugar Pill|The control subjects received a matching sugar pill for 12 weeks. Sugar Pill: Matching sugar pill
640405|NCT01102140|O1|Outcome|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.
POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
640406|NCT01102140|O2|Outcome|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.
Sugar Pill: Matching sugar pill"
640407|NCT01102140|O1|Outcome|POMx|"The POMx subjects will receive 1000 mg of oral POMx for 12 weeks.
POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
640408|NCT01102140|O2|Outcome|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.
Sugar Pill: Matching sugar pill"
640409|NCT01102140|O1|Outcome|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.
POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
640410|NCT01102140|O2|Outcome|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.
Sugar Pill: Matching sugar pill"
640411|NCT01102140|O1|Outcome|POMx|"The POMx subjects received 1000 mg of oral POMx for 12 weeks.
POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
640412|NCT01102140|E2|Reported Event|Control- Sugar Pill|"The control subjects received a matching sugar pill for 12 weeks.
Sugar Pill: Matching sugar pill"
640413|NCT01102140|E1|Reported Event|POMx|"15 subjects received 1000 mg of oral POMx for 12 weeks.
POMx, pomegranate polyphenol extract: 1000 mg orally once daily."
640414|NCT01102218|B3|Baseline|Total|Total of all reporting groups
640415|NCT01102218|B2|Baseline|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
640416|NCT01102218|B1|Baseline|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
640417|NCT01102218|P2|Participant Flow|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
640418|NCT01102218|P1|Participant Flow|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
640419|NCT01102218|O2|Outcome|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
640420|NCT01102218|O1|Outcome|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
640421|NCT01102218|E2|Reported Event|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
640422|NCT01102218|E1|Reported Event|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
640423|NCT01102257|B3|Baseline|Total|Total of all reporting groups
640424|NCT01102257|B2|Baseline|Olive Oil|5 Gel Capsules of olive oil taken orally daily
640425|NCT01102257|B1|Baseline|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
640426|NCT01102257|P2|Participant Flow|Olive Oil|5 Gel Capsules of olive oil to be taken orally daily
640427|NCT01102257|P1|Participant Flow|Omega-3 Supplement|5 Gel Capsules to be taken orally daily to give a total dose of 2000mg EPA and 1000 mg DHA
640428|NCT01102257|O2|Outcome|Olive Oil|5 Gel Capsules of olive oil taken orally daily
640429|NCT01102257|O1|Outcome|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
640430|NCT01102257|E2|Reported Event|Olive Oil|5 Gel Capsules of olive oil taken orally daily
640431|NCT01102257|E1|Reported Event|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
640432|NCT01102270|B1|Baseline|All Study Participants|all study participants who received all interventions
640433|NCT01102270|P2|Participant Flow|Sugar Pill First, Then Eszopiclone|Placebo : 1 placebo capsule prior to sleep then 3mg eszopiclone 1 week later
640434|NCT01102270|P1|Participant Flow|Eszopiclone First, Then Sugar Pill|Eszopiclone : 3mg tablet once prior to sleep followed by sugar pill (placebo) 1 week later
640435|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
640436|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
640437|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
640438|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
640439|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
640440|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
640441|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
640442|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
640443|NCT01102270|E2|Reported Event|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
640444|NCT01102270|E1|Reported Event|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
640445|NCT01102374|B3|Baseline|Total|Total of all reporting groups
640446|NCT01102374|B2|Baseline|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640447|NCT01102374|B1|Baseline|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640448|NCT01102374|P2|Participant Flow|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640449|NCT01102374|P1|Participant Flow|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640450|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640451|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640452|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640514|NCT01102764|E1|Reported Event|Arm 1: PE Via Telemedicine|"PE via telemedicine
Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
640453|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640454|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640455|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640456|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640457|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640458|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640459|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640523|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640460|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640461|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640462|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640463|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640464|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640465|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640466|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640467|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640468|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640469|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640470|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640471|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640472|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640515|NCT01102777|B3|Baseline|Total|Total of all reporting groups
640713|NCT01103271|P1|Participant Flow|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
640473|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640474|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640475|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640476|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640477|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640478|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640479|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640480|NCT01102374|E2|Reported Event|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640481|NCT01102374|E1|Reported Event|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
640482|NCT01102413|B3|Baseline|Total|Total of all reporting groups
640483|NCT01102413|B2|Baseline|Iron Sulphate|"Oral intake
Iron Sulphate: Oral intake"
640484|NCT01102413|B1|Baseline|Monofer|"Injections or infusions
Monofer: Infusion or injections"
640485|NCT01102413|P2|Participant Flow|Iron Sulphate|"Oral intake
Iron Sulphate: Oral intake"
640486|NCT01102413|P1|Participant Flow|Monofer|"Injections or infusions
Monofer: Infusion or injections"
640487|NCT01102413|O2|Outcome|Iron Sulphate|"Oral intake
Iron Sulphate: Oral intake"
640488|NCT01102413|O1|Outcome|Monofer|"Injections or infusions
Monofer: Infusion or injections"
640489|NCT01102413|O2|Outcome|Iron Sulphate|"Oral intake
Iron Sulphate: Oral intake"
640490|NCT01102413|O1|Outcome|Monofer|"Injections or infusions
Monofer: Infusion or injections"
640491|NCT01102413|E2|Reported Event|Iron Sulphate|"Oral intake
Iron Sulphate: Oral intake"
640492|NCT01102413|E1|Reported Event|Monofer|"Injections or infusions
Monofer: Infusion or injections"
640493|NCT01102491|B3|Baseline|Total|Total of all reporting groups
640494|NCT01102491|B2|Baseline|Control|no antiemetic prophylaxis
640495|NCT01102491|B1|Baseline|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
640496|NCT01102491|P2|Participant Flow|Control|no antiemetic prophylaxis
640497|NCT01102491|P1|Participant Flow|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
640498|NCT01102491|O2|Outcome|Control|no antiemetic prophylaxis
640499|NCT01102491|O1|Outcome|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
640500|NCT01102491|E2|Reported Event|Control|no antiemetic prophylaxis
640501|NCT01102491|E1|Reported Event|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
640502|NCT01102764|B3|Baseline|Total|Total of all reporting groups
640503|NCT01102764|B2|Baseline|Arm 2: PE in Person|"PE in person
In Person: PE therapy delivered in person at the VAMC"
640504|NCT01102764|B1|Baseline|Arm 1: PE Via Telemedicine|"PE via telemedicine
Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
640505|NCT01102764|P2|Participant Flow|Arm 2: PE in Person|"PE in person
In Person: PE therapy delivered in person at the VAMC"
640506|NCT01102764|P1|Participant Flow|Arm 1: PE Via Telemedicine|"PE via telemedicine
Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
640507|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person
In Person: PE therapy delivered in person at the VAMC"
640508|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine
Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
640509|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person
In Person: PE therapy delivered in person at the VAMC"
640510|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine
Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
640511|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person
In Person: PE therapy delivered in person at the VAMC"
640512|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine
Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
640513|NCT01102764|E2|Reported Event|Arm 2: PE in Person|"PE in person
In Person: PE therapy delivered in person at the VAMC"
640708|NCT01103232|E1|Reported Event|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
640516|NCT01102777|B2|Baseline|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640517|NCT01102777|B1|Baseline|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640518|NCT01102777|P2|Participant Flow|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640519|NCT01102777|P1|Participant Flow|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640520|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640521|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640522|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640524|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640525|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640526|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640527|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640528|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640529|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640530|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640531|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640532|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640533|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640534|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640535|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640536|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640537|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640709|NCT01103271|B3|Baseline|Total|Total of all reporting groups
644942|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
640538|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640539|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640540|NCT01102777|E2|Reported Event|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program
automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
640541|NCT01102777|E1|Reported Event|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
640542|NCT01102803|B3|Baseline|Total|Total of all reporting groups
640543|NCT01102803|B2|Baseline|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
640544|NCT01102803|B1|Baseline|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
640545|NCT01102803|P2|Participant Flow|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
640546|NCT01102803|P1|Participant Flow|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
640547|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
640548|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
640549|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
640550|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
640551|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
640552|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
640553|NCT01102803|O2|Outcome|Placebo+CBT Treatment|Participants receiving PL augmented CBT
640554|NCT01102803|O1|Outcome|DCS+CBT Treatment|Participants receiving DCS augmented CBT
640555|NCT01102803|E2|Reported Event|Pill Placebo + CBT|CBT augmented with sugar pill placebo
640556|NCT01102803|E1|Reported Event|DCS+CBT|CBT augmented with DCS (50mg)
640557|NCT01102894|B1|Baseline|Low Fiber and High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time Subjects also consumed low fiber
SmartPill : SmartPill"
640558|NCT01102894|P1|Participant Flow|High Fiber and Low Fiber|"Subjects consume a low and high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time
SmartPill : SmartPill"
640559|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time
SmartPill : SmartPill"
640560|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time
SmartPill : SmartPill"
640561|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time
SmartPill : SmartPill"
640562|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time
SmartPill : SmartPill"
640563|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time
SmartPill : SmartPill"
640564|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time
SmartPill : SmartPill"
640565|NCT01102894|E2|Reported Event|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time
SmartPill : SmartPill"
640566|NCT01102894|E1|Reported Event|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time
SmartPill : SmartPill"
640567|NCT01102972|B3|Baseline|Total|Total of all reporting groups
640568|NCT01102972|B2|Baseline|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640569|NCT01102972|B1|Baseline|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640570|NCT01102972|P2|Participant Flow|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640571|NCT01102972|P1|Participant Flow|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640572|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640573|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640574|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640575|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640576|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640577|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640578|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640579|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640580|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640581|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640582|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640583|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640584|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640585|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640586|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640587|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640588|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640589|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640590|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640591|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640592|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640593|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640594|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640595|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640596|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640597|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640598|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640599|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640600|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640601|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640602|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640603|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640604|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640605|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640710|NCT01103271|B2|Baseline|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
640606|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640607|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640608|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640609|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640610|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640611|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640612|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640613|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640614|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640615|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640616|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640617|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640618|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640619|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640620|NCT01102972|E2|Reported Event|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
640621|NCT01102972|E1|Reported Event|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
640622|NCT01103063|B3|Baseline|Total|Total of all reporting groups
640623|NCT01103063|B2|Baseline|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640624|NCT01103063|B1|Baseline|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640625|NCT01103063|P2|Participant Flow|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640626|NCT01103063|P1|Participant Flow|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640627|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640628|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640629|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640630|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640631|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640632|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
644943|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
640633|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640634|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640635|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640636|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640637|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640638|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640639|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640725|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
DiaPep277: 1.0 mg dose in 0.5 mL of solution"
640640|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640641|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640642|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640643|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640644|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640645|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640646|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640647|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640648|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640649|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640650|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640651|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640652|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640653|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640711|NCT01103271|B1|Baseline|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
640798|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640654|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640655|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640656|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640657|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640658|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640659|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640660|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640661|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640662|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640663|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640664|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640665|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640666|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640667|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640668|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640669|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640670|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640671|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640672|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640673|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640674|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640712|NCT01103271|P2|Participant Flow|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
640799|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
640675|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640676|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640677|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640678|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640679|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640680|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640681|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640682|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640683|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640684|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640685|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640686|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640687|NCT01103063|E4|Reported Event|Neonate (Sulfadoxine + Pyrimethamine)|Live births of participants who received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640688|NCT01103063|E3|Reported Event|Neonate (Azithromycin + Chloroquine)|Live births of participants who received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640689|NCT01103063|E2|Reported Event|Mother (Sulfadoxine + Pyrimethamine)|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
640690|NCT01103063|E1|Reported Event|Mother (Azithromycin + Chloroquine)|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
640691|NCT01103141|B3|Baseline|Total|Total of all reporting groups
640692|NCT01103141|B2|Baseline|Routine Access|Standard gauge-18 large-bore needle
640693|NCT01103141|B1|Baseline|Micropuncture|Gauge-21 Micropuncture® needle
640694|NCT01103141|P2|Participant Flow|Routine Access|Standard gauge-18 large-bore needle
640695|NCT01103141|P1|Participant Flow|Micropuncture|Gauge-21 Micropuncture® needle
640696|NCT01103141|O2|Outcome|Routine Access|Standard gauge-18 large-bore needle
640697|NCT01103141|O1|Outcome|Micropuncture|Gauge-21 Micropuncture® needle
640698|NCT01103141|E2|Reported Event|Routine Access|Standard gauge-18 large-bore needle
640699|NCT01103141|E1|Reported Event|Micropuncture|Gauge-21 Micropuncture® needle
640700|NCT01103232|B3|Baseline|Total|Total of all reporting groups
640701|NCT01103232|B2|Baseline|Control|Transcutaneous electrical nerve stimulation was applied
640702|NCT01103232|B1|Baseline|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
640703|NCT01103232|P2|Participant Flow|Control|Transcutaneous electrical nerve stimulation was applied
640704|NCT01103232|P1|Participant Flow|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
640705|NCT01103232|O2|Outcome|Control|Transcutaneous electrical nerve stimulation was applied
640706|NCT01103232|O1|Outcome|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
640707|NCT01103232|E2|Reported Event|Control|Transcutaneous electrical nerve stimulation was applied
640714|NCT01103271|O2|Outcome|Placebo Comparator: Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
640715|NCT01103271|O1|Outcome|Open Label-Placebo: Immediate Treatment|Participants assigned to immediate treatment will begin taking placebo pills for four weeks immediately after enrolling in the study.
640716|NCT01103271|O1|Outcome|Placebo Effect Study|These were all participants who were screened for the study but not yet enrolled.
640717|NCT01103271|E2|Reported Event|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
640718|NCT01103271|E1|Reported Event|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
640719|NCT01103284|B3|Baseline|Total|Total of all reporting groups
640720|NCT01103284|B2|Baseline|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Placebo: 40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
640721|NCT01103284|B1|Baseline|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
DiaPep277: 1.0 mg dose in 0.5 mL of solution"
640722|NCT01103284|P2|Participant Flow|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Placebo: 40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
640723|NCT01103284|P1|Participant Flow|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
DiaPep277: 1.0 mg dose in 0.5 mL of solution"
640724|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Placebo: 40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
640726|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Placebo: 40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
640727|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
DiaPep277: 1.0 mg dose in 0.5 mL of solution"
640728|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Placebo: 40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
640729|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
DiaPep277: 1.0 mg dose in 0.5 mL of solution"
640730|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Placebo: 40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
640731|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
DiaPep277: 1.0 mg dose in 0.5 mL of solution"
640732|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Placebo: 40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
640733|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
DiaPep277: 1.0 mg dose in 0.5 mL of solution"
640734|NCT01103284|E2|Reported Event|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Placebo: 40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
640735|NCT01103284|E1|Reported Event|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
DiaPep277: 1.0 mg dose in 0.5 mL of solution"
640736|NCT01103323|B3|Baseline|Total|Total of all reporting groups
640737|NCT01103323|B2|Baseline|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
640738|NCT01103323|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
640739|NCT01103323|P2|Participant Flow|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). Period 1 is placebo and placebo-regorafenib with placebo period only before unblinding. Period 2 is placebo-regorafenib with regorafenib period only.
640740|NCT01103323|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
640741|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
640742|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
640743|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
640744|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
640800|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640745|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
640746|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
640747|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
640748|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
640749|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
640750|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
640751|NCT01103323|E3|Reported Event|Placebo - Regorafenib After Unblinding|Participants in the placebo+BSC group switched to treatment with Regorafenib after unblinding. It is for Regorafenib treatment period only
640752|NCT01103323|E2|Reported Event|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). It is for placebo period only before unblinding.
640753|NCT01103323|E1|Reported Event|Regorafenib (BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
640754|NCT01103362|B1|Baseline|Flibanserin 100mg|"flibanserin 100mg po qd
flibanserin: all patients will receive open-label flibanserin 100mg"
640755|NCT01103362|P1|Participant Flow|Flibanserin 100mg|"flibanserin 100mg po qd
flibanserin: all patients will receive open-label flibanserin 100mg"
640756|NCT01103362|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd
flibanserin: all patients will receive open-label flibanserin 100mg"
640757|NCT01103362|E1|Reported Event|Flibanserin 100mg|"flibanserin 100mg po qd
flibanserin: all patients will receive open-label flibanserin 100mg"
640761|NCT01103414|B3|Baseline|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640762|NCT01103414|B2|Baseline|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640763|NCT01103414|B1|Baseline|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640764|NCT01103414|P5|Participant Flow|Matching Placebo|Over-encapsulated placebo tablet
640765|NCT01103414|P4|Participant Flow|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640766|NCT01103414|P3|Participant Flow|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640767|NCT01103414|P2|Participant Flow|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640768|NCT01103414|P1|Participant Flow|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640769|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
640770|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640771|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640772|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640773|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640774|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
640775|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640776|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640777|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640778|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640779|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
640780|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640781|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640782|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640783|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640784|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
640785|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640786|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640787|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640788|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640789|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
640790|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640791|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640792|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640793|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640794|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
640795|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640796|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640797|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640801|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640802|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640803|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640804|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
640805|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640806|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640807|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640808|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640809|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
640810|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640811|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640812|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640813|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640814|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
640815|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640816|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640817|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640818|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640819|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
640820|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640821|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640822|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640823|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640824|NCT01103414|E5|Reported Event|Matching Placebo|Over-encapsulated placebo tablet
642216|NCT01106287|P3|Participant Flow|MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg|Treatment Sequence 3
640825|NCT01103414|E4|Reported Event|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
640826|NCT01103414|E3|Reported Event|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
640827|NCT01103414|E2|Reported Event|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
640828|NCT01103414|E1|Reported Event|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
640829|NCT01103466|B1|Baseline|All Study Parcipitants|All parcipitants recieved all three intervention and they are therefore combined into one group.
640830|NCT01103466|P3|Participant Flow|Conform2|"Commercially available base plate
All subjects tested this test product in one period during the study.
No parcipitants recieved the same study intervention more than once"
640831|NCT01103466|P2|Participant Flow|SenSura|"Commercially available base plate
All subjects tested this test product in one period during the study.
No parcipitants recieved the same study intervention more than once"
640832|NCT01103466|P1|Participant Flow|Atlas|"New base plate
All subjects tested this test product in one period during the study.
No parcipitants recieved the same study intervention more than once"
640833|NCT01103466|O3|Outcome|Conform2|base plate
640834|NCT01103466|O2|Outcome|SenSura|base plate
640835|NCT01103466|O1|Outcome|Atlas|new base plate
640836|NCT01103466|E3|Reported Event|Conform2|base plate
640837|NCT01103466|E2|Reported Event|SenSura|base plate
640838|NCT01103466|E1|Reported Event|Atlas|new base plate
640839|NCT01103479|B4|Baseline|Total|Total of all reporting groups
640840|NCT01103479|B3|Baseline|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
640841|NCT01103479|B2|Baseline|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
640842|NCT01103479|B1|Baseline|Control|Participants will complete interviewer-administered pre- and post-test
640843|NCT01103479|P3|Participant Flow|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
640844|NCT01103479|P2|Participant Flow|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
641754|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose
UT-15C: oral"
640845|NCT01103479|P1|Participant Flow|Control|Participants will complete interviewer-administered pre- and post-test
640846|NCT01103479|O2|Outcome|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
640847|NCT01103479|O1|Outcome|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
640848|NCT01103479|O2|Outcome|Intervention|"Participants in either the Physician Intervention or Physician and Patient Intervention Arms.
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co"
640849|NCT01103479|O1|Outcome|Control|Participants will complete interviewer-administered pre- and post-test
640869|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640943|NCT01096550|B2|Baseline|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.
Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
640850|NCT01103479|O2|Outcome|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
640851|NCT01103479|O1|Outcome|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
640852|NCT01103479|O2|Outcome|Intervention|"Participants in either the Physician Intervention or Physician and Patient Intervention Arms.
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co"
640853|NCT01103479|O1|Outcome|Control|Participants will complete interviewer-administered pre- and post-test
640854|NCT01103479|E3|Reported Event|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
640855|NCT01103479|E2|Reported Event|Physician Training|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
640856|NCT01103479|E1|Reported Event|Control|Participants will complete interviewer-administered pre- and post-test
640857|NCT01103492|B1|Baseline|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
640858|NCT01103492|P1|Participant Flow|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
640859|NCT01103492|O1|Outcome|Ablation Treatment|Subjects with radiation proctitis who met inclusion criteria
640860|NCT01103492|E1|Reported Event|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
640861|NCT01103713|B1|Baseline|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
640862|NCT01103713|P1|Participant Flow|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
644944|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
640863|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640864|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640865|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640866|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640867|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640868|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640895|NCT01103934|O1|Outcome|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season
Vitamin D3: 4000 IU once daily
Fluticasone Propionate: 200 mcg daily, intranasal"
640870|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640871|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640872|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640873|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640874|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640875|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640876|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640877|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640878|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640879|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640880|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640881|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
640882|NCT01103713|O1|Outcome|Azithromycin/Chloroquine (AZCQ)|This is an open label, single arm study conducted in pregnant women during their second and third trimesters of pregnancy. Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
640883|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
640884|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
640885|NCT01103713|E2|Reported Event|Azithromycin/Chloroquine (Familial Status = Mother)|ACZQ (Familial Status = Mother)
640886|NCT01103713|E1|Reported Event|Azithromycin/Chloroquine (Familial Status = Neonate)|AZCQ (Familial Status = Neonate)
640887|NCT01103934|B3|Baseline|Total|Total of all reporting groups
640888|NCT01103934|B2|Baseline|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
Placebo: Placebo taken once daily
Fluticasone Propionate: 200 mcg daily, intranasal"
640889|NCT01103934|B1|Baseline|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season
Vitamin D3: 4000 IU once daily
Fluticasone Propionate: 200 mcg daily, intranasal"
640890|NCT01103934|P2|Participant Flow|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
Placebo: Placebo taken once daily
Fluticasone Propionate: 200 mcg daily, intranasal"
640891|NCT01103934|P1|Participant Flow|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season
Vitamin D3: 4000 IU once daily
Fluticasone Propionate: 200 mcg daily, intranasal"
640892|NCT01103934|O2|Outcome|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
Placebo: Placebo taken once daily
Fluticasone Propionate: 200 mcg daily, intranasal"
640893|NCT01103934|O1|Outcome|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season
Vitamin D3: 4000 IU once daily
Fluticasone Propionate: 200 mcg daily, intranasal"
640894|NCT01103934|O2|Outcome|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
Placebo: Placebo taken once daily
Fluticasone Propionate: 200 mcg daily, intranasal"
640896|NCT01103934|E2|Reported Event|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
Placebo: Placebo taken once daily
Fluticasone Propionate: 200 mcg daily, intranasal"
640897|NCT01103934|E1|Reported Event|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season
Vitamin D3: 4000 IU once daily
Fluticasone Propionate: 200 mcg daily, intranasal"
640898|NCT01103960|B3|Baseline|Total|Total of all reporting groups
640899|NCT01103960|B2|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640900|NCT01103960|B1|Baseline|A5 Alone|Amlodipine 5mg monotherapy
640901|NCT01103960|P2|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640902|NCT01103960|P1|Participant Flow|A5 Alone|Amlodipine 5mg monotherapy
640903|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640904|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
640905|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640906|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
640907|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640908|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
640909|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640910|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
640911|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640912|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
640913|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640914|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
640915|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640916|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
640917|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640918|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
640919|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640920|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
640921|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
640922|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
640923|NCT01103960|E2|Reported Event|T80/A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily
640924|NCT01103960|E1|Reported Event|A5 Alone|Amlodipine 5 mg one daily
640925|NCT01103973|B3|Baseline|Total|Total of all reporting groups
640926|NCT01103973|B2|Baseline|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Mind/Body Program: Ten week group mind/body program"
640927|NCT01103973|B1|Baseline|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.
Control: Spa gift certificates"
640928|NCT01103973|P2|Participant Flow|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Mind/Body Program: Ten week group mind/body program"
640929|NCT01103973|P1|Participant Flow|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.
Control: Spa gift certificates"
640930|NCT01103973|O2|Outcome|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Mind/Body Program: Ten week group mind/body program"
640931|NCT01103973|O1|Outcome|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.
Control: Spa gift certificates"
640932|NCT01103973|E2|Reported Event|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Mind/Body Program: Ten week group mind/body program"
640933|NCT01103973|E1|Reported Event|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.
Control: Spa gift certificates"
640934|NCT01096446|B3|Baseline|Total|Total of all reporting groups
640935|NCT01096446|B2|Baseline|Higher Infusion|Infants randomized into the control group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
640936|NCT01096446|B1|Baseline|Standard Infusion|Infants randomized into the experimental group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
640937|NCT01096446|P2|Participant Flow|Standard Infusion|Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
640938|NCT01096446|P1|Participant Flow|Higher Infusion|Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
640939|NCT01096446|O2|Outcome|Standard Infusion|Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
640940|NCT01096446|O1|Outcome|Higher Infusion|Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
640941|NCT01096446|E1|Reported Event|Serum Triglycerides|Serum triglycerides <201 mg/dl in both arms were considered to be normal. If serum triglycerides in either arm was above 201 mg/dl than the Intralipids was decreased based on the algorithm for adjusting IVFE when hypertriglyceridemia occured.
640942|NCT01096550|B3|Baseline|Total|Total of all reporting groups
640944|NCT01096550|B1|Baseline|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
640945|NCT01096550|P2|Participant Flow|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.
Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
640946|NCT01096550|P1|Participant Flow|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
640947|NCT01096550|O2|Outcome|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.
Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
640948|NCT01096550|O1|Outcome|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
640949|NCT01096550|E2|Reported Event|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.
Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
640950|NCT01096550|E1|Reported Event|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
640951|NCT01096589|B5|Baseline|Total|Total of all reporting groups
640952|NCT01096589|B4|Baseline|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk
Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
640953|NCT01096589|B3|Baseline|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640954|NCT01096589|B2|Baseline|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640955|NCT01096589|B1|Baseline|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640956|NCT01096589|P4|Participant Flow|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk
Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
640957|NCT01096589|P3|Participant Flow|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640958|NCT01096589|P2|Participant Flow|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640959|NCT01096589|P1|Participant Flow|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640960|NCT01096589|O4|Outcome|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk
Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
640961|NCT01096589|O3|Outcome|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640962|NCT01096589|O2|Outcome|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640963|NCT01096589|O1|Outcome|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640964|NCT01096589|E4|Reported Event|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk
Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
640965|NCT01096589|E3|Reported Event|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640966|NCT01096589|E2|Reported Event|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640967|NCT01096589|E1|Reported Event|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
640968|NCT01096680|B6|Baseline|Total|Total of all reporting groups
640969|NCT01096680|B5|Baseline|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640970|NCT01096680|B4|Baseline|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640971|NCT01096680|B3|Baseline|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640972|NCT01096680|B2|Baseline|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640973|NCT01096680|B1|Baseline|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640974|NCT01096680|P5|Participant Flow|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640975|NCT01096680|P4|Participant Flow|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640976|NCT01096680|P3|Participant Flow|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640977|NCT01096680|P2|Participant Flow|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640978|NCT01096680|P1|Participant Flow|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640979|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640980|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640981|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640982|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640983|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640984|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640985|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640986|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640987|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640988|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640989|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640990|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640991|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640992|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640993|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640994|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640995|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640996|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640997|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640998|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
640999|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
641000|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
641001|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
641002|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
641003|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
641004|NCT01096680|E5|Reported Event|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
641005|NCT01096680|E4|Reported Event|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
641006|NCT01096680|E3|Reported Event|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
641105|NCT01096875|E2|Reported Event|Placebo|"Atorvastatin like pill
Placebo : 1tb/day once daily for two weeks prior to surgery"
641007|NCT01096680|E2|Reported Event|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
641008|NCT01096680|E1|Reported Event|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
641009|NCT01096771|B3|Baseline|Total|Total of all reporting groups
641010|NCT01096771|B2|Baseline|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641011|NCT01096771|B1|Baseline|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641012|NCT01096771|P2|Participant Flow|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641013|NCT01096771|P1|Participant Flow|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641014|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641015|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641016|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641017|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641018|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641019|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641020|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641021|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641022|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641023|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641024|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641025|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641026|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641027|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
644065|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
641028|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641029|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641030|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641031|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641032|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641033|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641034|NCT01096771|E2|Reported Event|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
641035|NCT01096771|E1|Reported Event|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
641036|NCT01096784|B3|Baseline|Total|Total of all reporting groups
641037|NCT01096784|B2|Baseline|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641038|NCT01096784|B1|Baseline|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641039|NCT01096784|P2|Participant Flow|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641040|NCT01096784|P1|Participant Flow|rhIGF-1/rhIGFBP-3|Participants received insulin-like growth factor (rhIGF-I)/insulin-like growth factor binding protein-3 (rhIGFBP-3) 250 microgram per kilogram (mcg/kg) for 24 hours through continuous intravenous (IV) infusion from Day 0 up to 29 weeks 6 days of post-menstrual age (PMA).
641041|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641042|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641043|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641044|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641045|NCT01096784|O2|Outcome|Control|Participants in this control group do not received any treatment other than the standard care.
641046|NCT01096784|O1|Outcome|rhIGF-I/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641047|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641048|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641049|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641050|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641051|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641052|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641053|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641054|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641055|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641056|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641057|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641058|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641059|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641060|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641061|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641062|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641063|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641064|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641065|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641066|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641067|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641068|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641069|NCT01096784|E2|Reported Event|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
641289|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
641070|NCT01096784|E1|Reported Event|rhIGF-I/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
641071|NCT01096810|B1|Baseline|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
641072|NCT01096810|P1|Participant Flow|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
641073|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
641074|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
641075|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
641076|NCT01096810|E1|Reported Event|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
641077|NCT01096823|B3|Baseline|Total|Total of all reporting groups
641078|NCT01096823|B2|Baseline|Waitlist Control|Standard of care waitlist control group
641079|NCT01096823|B1|Baseline|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
641080|NCT01096823|P2|Participant Flow|Waitlist Control|Standard of care waitlist control group
641081|NCT01096823|P1|Participant Flow|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
641082|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
641083|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
641084|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
641085|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
641086|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
641087|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
641088|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
641089|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
641090|NCT01096823|E2|Reported Event|Waitlist Control|Standard of care waitlist control group
641091|NCT01096823|E1|Reported Event|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
641092|NCT01096875|B3|Baseline|Total|Total of all reporting groups
641093|NCT01096875|B2|Baseline|Placebo|"Atorvastatin like pill
Placebo : 1tb/day once daily for two weeks prior to surgery"
641094|NCT01096875|B1|Baseline|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
641095|NCT01096875|P2|Participant Flow|Placebo|"Atorvastatin like pill
Placebo : 1tb/day once daily for two weeks prior to surgery"
641096|NCT01096875|P1|Participant Flow|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
641097|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill
Placebo: 1tb/day once daily for two weeks prior to surgery"
641098|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin: 40mg/day once daily for two weeks prior to surgery"
641099|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill
Placebo: 1tb/day once daily for two weeks prior to surgery"
641100|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin: 40mg/day once daily for two weeks prior to surgery"
641101|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill
Placebo : 1tb/day once daily for two weeks prior to surgery"
641102|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
641103|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill
Placebo : 1tb/day once daily for two weeks prior to surgery"
641104|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
641106|NCT01096875|E1|Reported Event|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
641107|NCT01097005|B1|Baseline|Clarithromycin|Those with an exposure
641108|NCT01097005|P1|Participant Flow|Clarithromycin|Those with an exposure
641109|NCT01097005|O1|Outcome|Clarithromycin|The subjects who completed the study
641110|NCT01097005|O1|Outcome|Clarithromycin|Those with an exposure
641111|NCT01097005|O1|Outcome|Clarithromycin|Negative conversion / Yes
641112|NCT01097005|E1|Reported Event|Clarithromycin|Those with an exposure
641113|NCT01097057|B1|Baseline|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV"
641114|NCT01097057|P1|Participant Flow|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV"
641140|NCT01097421|E1|Reported Event|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
641141|NCT01097460|B1|Baseline|MM-111 + Herceptin|"MM-111 will be combined with Herceptin
MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
641115|NCT01097057|O1|Outcome|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV"
641116|NCT01097057|O1|Outcome|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV"
641117|NCT01097057|O1|Outcome|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV"
641118|NCT01097057|O1|Outcome|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV"
641119|NCT01097057|E1|Reported Event|Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)|"Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV"
641120|NCT01097304|B1|Baseline|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Ursodiol: Given PO
Laboratory Biomarker Analysis: Correlative studies"
641121|NCT01097304|P1|Participant Flow|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Ursodiol: Given PO
Laboratory Biomarker Analysis: Correlative studies"
641122|NCT01097304|O1|Outcome|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Ursodiol: Given PO
Laboratory Biomarker Analysis: Correlative studies"
641123|NCT01097304|E1|Reported Event|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Ursodiol: Given PO
Laboratory Biomarker Analysis: Correlative studies"
641124|NCT01097343|B1|Baseline|Cross-over Study|All Study Participants
641125|NCT01097343|P2|Participant Flow|150 mg First 30 Days, Followed by 75 mg|25 patients with the target allele were identified, and received 150 mg clopidogrel followed by 75 mg clopidogrel for two daily for separate dosing periods of 30 days
641126|NCT01097343|P1|Participant Flow|75 mg First 30 Days, Followed by 150 mg|25 patients with the target allele were identified, and receive 75mg followed by 150 mg clopidogrel daily for two separate dosing periods of 30 days
641127|NCT01097343|O2|Outcome|Cross-over Study - 150 mg Dose|Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
644945|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
641128|NCT01097343|O1|Outcome|Cross-over Study- 75 mg Dose|Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
641129|NCT01097343|E2|Reported Event|150 mg Followed by 75 mg|Cross-over study
641130|NCT01097343|E1|Reported Event|75 mg Followed by 150 mg|Cross-over study
641131|NCT01097421|B1|Baseline|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
641132|NCT01097421|P1|Participant Flow|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
641133|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
641134|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
641135|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
641136|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
641137|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
641138|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
641139|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
641287|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
641142|NCT01097460|P1|Participant Flow|MM-111 + Herceptin|"MM-111 will be combined with Herceptin
MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
641143|NCT01097460|O1|Outcome|MM-111 + Herceptin|"MM-111 will be combined with Herceptin
MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
641144|NCT01097460|E1|Reported Event|MM-111 + Herceptin|"MM-111 will be combined with Herceptin
MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
641145|NCT01097616|B4|Baseline|Total|Total of all reporting groups
641146|NCT01097616|B3|Baseline|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641147|NCT01097616|B2|Baseline|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641148|NCT01097616|B1|Baseline|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641149|NCT01097616|P8|Participant Flow|Placebo (RO, After Placebo in TRT/EXT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641150|NCT01097616|P7|Participant Flow|Placebo (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641151|NCT01097616|P6|Participant Flow|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
641152|NCT01097616|P5|Participant Flow|Placebo (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641153|NCT01097616|P4|Participant Flow|Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
641154|NCT01097616|P3|Participant Flow|Placebo (TRT/EXT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase, and could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
641155|NCT01097616|P2|Participant Flow|Suvorexant High Dose (HD) (TRT/EXT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
641156|NCT01097616|P1|Participant Flow|Suvorexant Low Dose (LD) (TRT/Extension [EXT] Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
641157|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641158|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641159|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641160|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641161|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641162|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641163|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641164|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641165|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641166|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641167|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641168|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641169|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641170|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641171|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641172|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641173|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641174|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641175|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641176|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641177|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641178|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641179|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641180|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641181|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641182|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641183|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641184|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641185|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641186|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641187|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641188|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641189|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641190|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641191|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641192|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641193|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641194|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641195|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641196|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641197|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641198|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641199|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641200|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641201|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
644066|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
641202|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641203|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641204|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641205|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641206|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641207|NCT01097616|E19|Reported Event|Placebo (RO, After Placebo in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT/EXT and RO Phases.
641208|NCT01097616|E18|Reported Event|Placebo (RO, After Suvorexant HD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT Phase and placebo during RO Phase.
641209|NCT01097616|E17|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT and RO Phases.
641210|NCT01097616|E16|Reported Event|Placebo (RO, After Suvorexant LD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT Phase and placebo during RO Phase.
641211|NCT01097616|E15|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT and RO Phases.
641212|NCT01097616|E14|Reported Event|Placebo (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received placebo during TRT/EXT Phase.
641213|NCT01097616|E13|Reported Event|Suvorexant HD (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant HD during TRT/EXT Phase.
641214|NCT01097616|E12|Reported Event|Suvorexant LD (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant LD during TRT/EXT Phase.
641215|NCT01097616|E11|Reported Event|Placebo (RO, After Placebo in TRT/EXT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641216|NCT01097616|E10|Reported Event|Placebo (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641217|NCT01097616|E9|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
641218|NCT01097616|E8|Reported Event|Placebo (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641457|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641219|NCT01097616|E7|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
641220|NCT01097616|E6|Reported Event|Placebo (EXT Phase)|After receiving placebo to suvorexant during the 3-month DB TRT Phase, participants could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
641221|NCT01097616|E5|Reported Event|Suvorexant HD (EXT Phase)|After receiving suvorexant HD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
641222|NCT01097616|E4|Reported Event|Suvorexant LD (EXT Phase)|After receiving suvorexant LD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
641223|NCT01097616|E3|Reported Event|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
641224|NCT01097616|E2|Reported Event|Suvorexant HD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641225|NCT01097616|E1|Reported Event|Suvorexant LD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641226|NCT01097629|B4|Baseline|Total|Total of all reporting groups
641227|NCT01097629|B3|Baseline|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641228|NCT01097629|B2|Baseline|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641229|NCT01097629|B1|Baseline|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641230|NCT01097629|P8|Participant Flow|Placebo (RO, After Placebo in TRT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641231|NCT01097629|P7|Participant Flow|Placebo (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641232|NCT01097629|P6|Participant Flow|Suvorexant HD (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
641233|NCT01097629|P5|Participant Flow|Placebo (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641234|NCT01097629|P4|Participant Flow|Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
641235|NCT01097629|P3|Participant Flow|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641236|NCT01097629|P2|Participant Flow|Suvorexant High Dose (HD) (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641237|NCT01097629|P1|Participant Flow|Suvorexant Low Dose (LD) (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641238|NCT01097629|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641239|NCT01097629|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641240|NCT01097629|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641241|NCT01097629|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641242|NCT01097629|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641243|NCT01097629|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641244|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641245|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641246|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641247|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641248|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641458|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641249|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641250|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641251|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641252|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641253|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641254|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641255|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641256|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641257|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641288|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
641258|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641259|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641260|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641261|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641262|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641263|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641264|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641265|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641266|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641267|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641268|NCT01097629|E16|Reported Event|Placebo (RO, After Placebo in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT and RO Phases.
641269|NCT01097629|E15|Reported Event|Placebo (RO, After Suvorexant HD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT Phase and placebo during RO Phase.
641270|NCT01097629|E14|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT and RO Phases.
641271|NCT01097629|E13|Reported Event|Placebo (RO, After Suvorexant LD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT Phase and placebo during RO Phase.
641272|NCT01097629|E12|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT and RO Phases.
641273|NCT01097629|E11|Reported Event|Placebo (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received placebo during TRT Phase.
641274|NCT01097629|E10|Reported Event|Suvorexant HD (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant HD during TRT Phase.
641275|NCT01097629|E9|Reported Event|Suvorexant LD (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant LD during TRT Phase.
641276|NCT01097629|E8|Reported Event|Placebo (RO, After Placebo in TRT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641755|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily
UT-15C: oral"
641277|NCT01097629|E7|Reported Event|Placebo (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641278|NCT01097629|E6|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
641279|NCT01097629|E5|Reported Event|Placebo (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
641280|NCT01097629|E4|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
641281|NCT01097629|E3|Reported Event|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
641282|NCT01097629|E2|Reported Event|Suvorexant HD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641283|NCT01097629|E1|Reported Event|Suvorexant LD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
641284|NCT01097655|B1|Baseline|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
641285|NCT01097655|P1|Participant Flow|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
641286|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
644067|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
641290|NCT01097655|E1|Reported Event|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
641291|NCT01097668|B3|Baseline|Total|Total of all reporting groups
641292|NCT01097668|B2|Baseline|Subcutaneous Injection|Injections of ATX-MS-1467 given by the subcutaneous route
641293|NCT01097668|B1|Baseline|Intradermal Injection|Injections of ATX-MS-1467 given by the intradermal route
641294|NCT01097668|P2|Participant Flow|Subcutaneous Injection|Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
641295|NCT01097668|P1|Participant Flow|Intradermal Injection|Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
641296|NCT01097668|O2|Outcome|Subcutaneous Injection|Injections of ATX-MS-1467 administered by subcutaneous route
641297|NCT01097668|O1|Outcome|Intradermal|Injections of ATX-MS-1467 administered by intradermal route
641298|NCT01097668|O2|Outcome|Subcutaneous Injection|Injections of ATX-MS-1467 administered by the subcutaneous route
641299|NCT01097668|O1|Outcome|Intradermal Injection|Injections of ATX-MS-1467 administered by the intradermal route
641300|NCT01097668|E4|Reported Event|Subcutaneous Injection - Non Treatment Emergent|Follow-up period
641301|NCT01097668|E3|Reported Event|Intradermal Injection - Non Treatment Emergent|Follow-up period
641302|NCT01097668|E2|Reported Event|Subcutaneous Injection - Treatment Emergent|Injections will be administered by the subcutaneous route
641303|NCT01097668|E1|Reported Event|Intradermal Injection - Treatment Emergent|Injections will be administered by the intradermal route
641304|NCT01097694|B3|Baseline|Total|Total of all reporting groups
641305|NCT01097694|B2|Baseline|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641306|NCT01097694|B1|Baseline|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641307|NCT01097694|P2|Participant Flow|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641308|NCT01097694|P1|Participant Flow|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641309|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641310|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641311|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641312|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641313|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641314|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641315|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641316|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641317|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641318|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641319|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641320|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641321|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641322|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641323|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641324|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641325|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641326|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641327|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641408|NCT01097915|E2|Reported Event|Medium Tasters|Subjects sensitive to PROP
641409|NCT01097915|E1|Reported Event|Super Tasters|Subjects highly sensitive to PROP
641328|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641329|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641330|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641331|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641332|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641333|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641334|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641335|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641336|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641337|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641338|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641339|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641340|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641341|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641342|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641343|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641344|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641345|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641346|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641347|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641348|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641349|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641387|NCT01097863|O1|Outcome|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
641756|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily
UT-15C: oral"
641350|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641351|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641352|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641353|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641354|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641355|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641356|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641357|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641358|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641359|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641360|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641361|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641362|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641363|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641364|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641365|NCT01097694|E2|Reported Event|Placebo|"Group on Placebo treatment
Placebo: Placebo"
641366|NCT01097694|E1|Reported Event|Imatinib Mesylate|"Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
641367|NCT01097785|B3|Baseline|Total|Total of all reporting groups
641368|NCT01097785|B2|Baseline|Placebo, Then Simvastatin|Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
641369|NCT01097785|B1|Baseline|Simvastatin, Then Placebo|Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
641370|NCT01097785|P2|Participant Flow|Placebo, Then Simvastatin|Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
641371|NCT01097785|P1|Participant Flow|Simvastatin, Then Placebo|Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
641372|NCT01097785|O2|Outcome|Placebo|"Placebo cap 1 pill every day for 30 days
Placebo: 1 capsule daily for 30 days"
641373|NCT01097785|O1|Outcome|Simvastatin|40 mg Simvastatin 1 pill every day for 30 days
641374|NCT01097785|O2|Outcome|Placebo|Placebo cap 1 pill every day for 30 days
641375|NCT01097785|O1|Outcome|Simvastatin|40 mg Simvastatin 1 pill every day for 30 days
641376|NCT01097785|E2|Reported Event|Placebo|"Placebo cap 1 pill every day for 30 days
Placebo: 1 capsule daily for 30 days"
641377|NCT01097785|E1|Reported Event|Simvastatin|"40 mg Simvastatin 1 pill every day for 30 days
Simvastatin: 40 mg, P.O.,daily for 30 days"
641378|NCT01097863|B4|Baseline|Total|Total of all reporting groups
641379|NCT01097863|B3|Baseline|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
641380|NCT01097863|B2|Baseline|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
641381|NCT01097863|B1|Baseline|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
641382|NCT01097863|P3|Participant Flow|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
641383|NCT01097863|P2|Participant Flow|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
641384|NCT01097863|P1|Participant Flow|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
641385|NCT01097863|O3|Outcome|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
641386|NCT01097863|O2|Outcome|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
641757|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose
UT-15C: oral"
641388|NCT01097863|E3|Reported Event|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
641389|NCT01097863|E2|Reported Event|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
641390|NCT01097863|E1|Reported Event|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
641391|NCT01097915|B4|Baseline|Total|Total of all reporting groups
641392|NCT01097915|B3|Baseline|Non Tasters|Subjects no sensitive to PROP
641393|NCT01097915|B2|Baseline|Medium Tasters|Subjects sensitive to PROP
641394|NCT01097915|B1|Baseline|Super Tasters|Subjects highly sensitive to PROP
641395|NCT01097915|P3|Participant Flow|Non Tasters|Subjects no sensitive to PROP
641396|NCT01097915|P2|Participant Flow|Medium Tasters|Subjects sensitive to PROP
641397|NCT01097915|P1|Participant Flow|Super Tasters|Subjects highly sensitive to PROP
641398|NCT01097915|O3|Outcome|Non-tasters|Subjects no sensitive to PROP
641399|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
641400|NCT01097915|O1|Outcome|Super-tasters|Subjects highly sensitive to PROP
641401|NCT01097915|O3|Outcome|Non-tasters|Subjects no sensitive to PROP
641402|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
641403|NCT01097915|O1|Outcome|Super-tasters|Subjects highly sensitive to PROP
641404|NCT01097915|O3|Outcome|Non Tasters|Subjects no sensitive to PROP
641405|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
641406|NCT01097915|O1|Outcome|Super Tasters|Subjects highly sensitive to PROP
641407|NCT01097915|E3|Reported Event|Non Tasters|Subjects no sensitive to PROP
641411|NCT01098032|B2|Baseline|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
641412|NCT01098032|B1|Baseline|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
641413|NCT01098032|P2|Participant Flow|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
641414|NCT01098032|P1|Participant Flow|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
641415|NCT01098032|O2|Outcome|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
641416|NCT01098032|O1|Outcome|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
641417|NCT01098032|E2|Reported Event|Systemic Alone Therapy Group|Systemic alone therapy group was treated by intravenous sodium bicarbonate plus NAC administration.
641456|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641418|NCT01098032|E1|Reported Event|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure.
641419|NCT01098071|B1|Baseline|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
641420|NCT01098071|P1|Participant Flow|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
641421|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
641422|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
641423|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
641424|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
641425|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
641426|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
641427|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
641428|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
641429|NCT01098071|E1|Reported Event|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
641944|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
641430|NCT01098097|B1|Baseline|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
641431|NCT01098097|P1|Participant Flow|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
641432|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
641433|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
641434|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
641435|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
641436|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
641437|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
641438|NCT01098097|E1|Reported Event|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
641439|NCT01098110|B4|Baseline|Total|Total of all reporting groups
641440|NCT01098110|B3|Baseline|Placebo BID|Participants received matching placebo BID for 6 weeks.
641441|NCT01098110|B2|Baseline|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641442|NCT01098110|B1|Baseline|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641443|NCT01098110|P3|Participant Flow|Placebo BID|Participants received matching placebo BID for 6 weeks.
641444|NCT01098110|P2|Participant Flow|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641445|NCT01098110|P1|Participant Flow|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks.
641446|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641447|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641448|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641449|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641450|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641451|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641452|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641453|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641454|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641455|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641758|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily
UT-15C: oral"
641459|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641460|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641461|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641462|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641463|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641464|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641465|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641466|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641467|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641468|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641469|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641470|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641471|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641472|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641473|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641474|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641475|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641476|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641477|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641478|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641479|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
641480|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641481|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641482|NCT01098110|E3|Reported Event|Placebo BID|Participants received matching placebo BID for 6 weeks.
641483|NCT01098110|E2|Reported Event|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
641484|NCT01098110|E1|Reported Event|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
641485|NCT01098162|B1|Baseline|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
641486|NCT01098162|P1|Participant Flow|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
641487|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
641488|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
641489|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
641490|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
641491|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
641492|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
641493|NCT01098162|E1|Reported Event|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
641494|NCT01098240|B1|Baseline|Open-Label ADT|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
641495|NCT01098240|P3|Participant Flow|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641496|NCT01098240|P2|Participant Flow|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg every evening (QPM) for 3 days, then 1 mg twice daily (BID) for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641558|NCT01098318|E3|Reported Event|Sugar Pill|"Lactose monohydrate
Lactose monohydrate: 1-4 capsules daily"
641559|NCT01098318|E2|Reported Event|Sertraline|"Conventional anti-depressant
Sertraline: 50-200 mg daily"
641497|NCT01098240|P1|Participant Flow|Open-Label Antidepressant Treatment (ADT)|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 milligram/day [mg/d]), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine controlled-release (CR) (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
641498|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641499|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641500|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641501|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641571|NCT01104103|E1|Reported Event|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
641572|NCT01104116|B1|Baseline|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging
[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
641502|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641503|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641504|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641505|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641506|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641507|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641508|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641509|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641510|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641511|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641512|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641513|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641514|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641515|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641516|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641517|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641518|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641519|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641945|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
641520|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641521|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641522|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641523|NCT01098240|E3|Reported Event|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641524|NCT01098240|E2|Reported Event|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
641525|NCT01098240|E1|Reported Event|Open-Label ADT|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
641526|NCT01098253|B3|Baseline|Total|Total of all reporting groups
641527|NCT01098253|B2|Baseline|Usual Care|
641528|NCT01098253|B1|Baseline|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
641529|NCT01098253|P2|Participant Flow|Usual Care|
641530|NCT01098253|P1|Participant Flow|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
641531|NCT01098253|O2|Outcome|Usual Care|
641532|NCT01098253|O1|Outcome|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
641533|NCT01098253|O2|Outcome|Usual Care|
641534|NCT01098253|O1|Outcome|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
641535|NCT01098253|E2|Reported Event|Usual Care|
641536|NCT01098253|E1|Reported Event|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
641537|NCT01098305|B3|Baseline|Total|Total of all reporting groups
641538|NCT01098305|B2|Baseline|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
641560|NCT01098318|E1|Reported Event|Rhodiola Rosea|"Herbal extract
Herbal extract: 340-1,360 mg daily"
641561|NCT01104103|B3|Baseline|Total|Total of all reporting groups
641562|NCT01104103|B2|Baseline|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
641539|NCT01098305|B1|Baseline|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).
Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
641540|NCT01098305|P2|Participant Flow|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
641573|NCT01104116|P1|Participant Flow|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging
[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
641574|NCT01104116|O1|Outcome|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging
[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
641575|NCT01104116|O1|Outcome|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging
[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
641946|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
641541|NCT01098305|P1|Participant Flow|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).
Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
641542|NCT01098305|O2|Outcome|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
641543|NCT01098305|O1|Outcome|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).
Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
641544|NCT01098305|O2|Outcome|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
641545|NCT01098305|O1|Outcome|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).
Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
641546|NCT01098305|E2|Reported Event|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
641547|NCT01098305|E1|Reported Event|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).
Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
641548|NCT01098318|B4|Baseline|Total|Total of all reporting groups
641549|NCT01098318|B3|Baseline|Sugar Pill|"Lactose monohydrate
Lactose monohydrate: 1-4 capsules daily"
641550|NCT01098318|B2|Baseline|Sertraline|"Conventional anti-depressant
Sertraline: 50-200 mg daily"
641551|NCT01098318|B1|Baseline|Rhodiola Rosea|"Herbal extract
Herbal extract: 340-1,360 mg daily"
641552|NCT01098318|P3|Participant Flow|Sugar Pill|"Lactose monohydrate
Lactose monohydrate: 1-4 capsules daily"
641553|NCT01098318|P2|Participant Flow|Sertraline|"Conventional anti-depressant
Sertraline: 50-200 mg daily"
641554|NCT01098318|P1|Participant Flow|Rhodiola Rosea|"Herbal extract
Herbal extract: 340-1,360 mg daily"
641555|NCT01098318|O3|Outcome|Sugar Pill|"Lactose monohydrate
Lactose monohydrate: 1-4 capsules daily"
641556|NCT01098318|O2|Outcome|Sertraline|"Conventional anti-depressant
Sertraline: 50-200 mg daily"
641557|NCT01098318|O1|Outcome|Rhodiola Rosea|"Herbal extract
Herbal extract: 340-1,360 mg daily"
641563|NCT01104103|B1|Baseline|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
641564|NCT01104103|P2|Participant Flow|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
641565|NCT01104103|P1|Participant Flow|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
641566|NCT01104103|O2|Outcome|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
641567|NCT01104103|O1|Outcome|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
641568|NCT01104103|O2|Outcome|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
641569|NCT01104103|O1|Outcome|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
641570|NCT01104103|E2|Reported Event|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
642217|NCT01106287|P2|Participant Flow|MK-0941 60/80 mg/Pbo/MK-0941 120/140 mg|Treatment Sequence 2
641576|NCT01104116|E1|Reported Event|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging
[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
641577|NCT01104155|B3|Baseline|Total|Total of all reporting groups
641578|NCT01104155|B2|Baseline|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
641579|NCT01104155|B1|Baseline|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
641580|NCT01104155|P2|Participant Flow|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
641581|NCT01104155|P1|Participant Flow|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
641582|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
641583|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
641584|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
641585|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
641586|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
641587|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
641588|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
641589|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
641590|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
641591|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
641592|NCT01104155|E2|Reported Event|Eribulin Mesylate, 28 Day Cycle|eribulin mesylate + erlotinib: 28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.
641759|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily
UT-15C: oral"
641593|NCT01104155|E1|Reported Event|Eribulin Mesylate, 21 Day Cycle|eribulin mesylate + erlotinib: 21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.
641594|NCT01104207|B3|Baseline|Total|Total of all reporting groups
641595|NCT01104207|B2|Baseline|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.
placebo rTMS: placebo rTMS"
641596|NCT01104207|B1|Baseline|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.
repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
641597|NCT01104207|P2|Participant Flow|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.
placebo rTMS: placebo rTMS"
641598|NCT01104207|P1|Participant Flow|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.
repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
641599|NCT01104207|O2|Outcome|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.
placebo rTMS: placebo rTMS"
641600|NCT01104207|O1|Outcome|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.
repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
641601|NCT01104207|E2|Reported Event|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.
placebo rTMS: placebo rTMS"
641602|NCT01104207|E1|Reported Event|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.
repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
641603|NCT01104246|B1|Baseline|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
641604|NCT01104246|P1|Participant Flow|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
641605|NCT01104246|O1|Outcome|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
641606|NCT01104246|E1|Reported Event|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
641607|NCT01104285|B3|Baseline|Total|Total of all reporting groups
641608|NCT01104285|B2|Baseline|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
641609|NCT01104285|B1|Baseline|Standard Care|Treatment of pleural effusion with diuresis
641610|NCT01104285|P2|Participant Flow|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
641611|NCT01104285|P1|Participant Flow|Standard Care|Treatment of pleural effusion with diuresis
641612|NCT01104285|O2|Outcome|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
641613|NCT01104285|O1|Outcome|Standard Care|Treatment of pleural effusion with diuresis
641614|NCT01104285|E2|Reported Event|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
641615|NCT01104285|E1|Reported Event|Standard Care|Treatment of pleural effusion with diuresis
641616|NCT01104311|B3|Baseline|Total|Total of all reporting groups
641617|NCT01104311|B2|Baseline|Modest BP Lowering|Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
641618|NCT01104311|B1|Baseline|Aggressive BP Lowering|Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
641619|NCT01104311|P2|Participant Flow|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
641620|NCT01104311|P1|Participant Flow|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
641621|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)"
641622|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level (Safety population: 65)"
641623|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
641624|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
641625|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
641626|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
641760|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose
UT-15C: oral"
641627|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
641628|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
641629|NCT01104311|O2|Outcome|Modest BP Lowering|Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
641630|NCT01104311|O1|Outcome|Aggressive BP Lowering|Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
641631|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
641632|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
641633|NCT01104311|O2|Outcome|Modest BP Lowering|Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
641634|NCT01104311|O1|Outcome|Aggressive BP Lowering|Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
641635|NCT01104311|E2|Reported Event|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)"
641636|NCT01104311|E1|Reported Event|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level (Safety population: 65)"
641637|NCT01104636|B1|Baseline|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
641638|NCT01104636|P1|Participant Flow|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
641639|NCT01104636|O1|Outcome|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
641640|NCT01104636|O1|Outcome|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
641641|NCT01104636|E1|Reported Event|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
641642|NCT01104662|B9|Baseline|Total|Total of all reporting groups
641643|NCT01104662|B8|Baseline|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641644|NCT01104662|B7|Baseline|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
641645|NCT01104662|B6|Baseline|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641646|NCT01104662|B5|Baseline|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
641647|NCT01104662|B4|Baseline|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641711|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641648|NCT01104662|B3|Baseline|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
641649|NCT01104662|B2|Baseline|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641650|NCT01104662|B1|Baseline|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
641712|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
642218|NCT01106287|P1|Participant Flow|MK-0941 60/80/100/120 mg/Pbo|Treatment Sequence 1
641651|NCT01104662|P8|Participant Flow|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641652|NCT01104662|P7|Participant Flow|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
641653|NCT01104662|P6|Participant Flow|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641654|NCT01104662|P5|Participant Flow|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For complicated skin and skin structure infections (cSSSI) participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
641655|NCT01104662|P4|Participant Flow|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641656|NCT01104662|P3|Participant Flow|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
641657|NCT01104662|P2|Participant Flow|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin/semi-synthetic penicillin (SSP; for example, nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641658|NCT01104662|P1|Participant Flow|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
641748|NCT01104870|P3|Participant Flow|Dose Group 3|"individual Maximum Tolerated Dose
UT-15C: oral"
641659|NCT01104662|O8|Outcome|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641660|NCT01104662|O7|Outcome|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
641713|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641714|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641715|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641661|NCT01104662|O6|Outcome|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641662|NCT01104662|O5|Outcome|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
641663|NCT01104662|O4|Outcome|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641664|NCT01104662|O3|Outcome|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion
641665|NCT01104662|O2|Outcome|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641666|NCT01104662|O1|Outcome|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
641667|NCT01104662|O8|Outcome|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641668|NCT01104662|O7|Outcome|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
641669|NCT01104662|O6|Outcome|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641749|NCT01104870|P2|Participant Flow|Dose Group 2|"1.25 mg twice daily
UT-15C: oral"
641670|NCT01104662|O5|Outcome|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
641716|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641717|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641718|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641671|NCT01104662|O4|Outcome|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641672|NCT01104662|O3|Outcome|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
641673|NCT01104662|O2|Outcome|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641674|NCT01104662|O1|Outcome|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
641675|NCT01104662|E8|Reported Event|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641676|NCT01104662|E7|Reported Event|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
641677|NCT01104662|E6|Reported Event|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641678|NCT01104662|E5|Reported Event|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
641679|NCT01104662|E4|Reported Event|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641680|NCT01104662|E3|Reported Event|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
641710|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641750|NCT01104870|P1|Participant Flow|Dose Group 1|"0.25 mg twice daily
UT-15C: oral"
641719|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641720|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
642219|NCT01106287|O6|Outcome|Placebo|All participants receiving placebo
641681|NCT01104662|E2|Reported Event|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
641682|NCT01104662|E1|Reported Event|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.)
641683|NCT01104701|B5|Baseline|Total|Total of all reporting groups
641684|NCT01104701|B4|Baseline|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
641685|NCT01104701|B3|Baseline|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. .
641686|NCT01104701|B2|Baseline|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
641687|NCT01104701|B1|Baseline|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC).
641688|NCT01104701|P4|Participant Flow|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641689|NCT01104701|P3|Participant Flow|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641690|NCT01104701|P2|Participant Flow|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641691|NCT01104701|P1|Participant Flow|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641692|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641693|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641694|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641695|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641696|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641697|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641698|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641699|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641700|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641701|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641702|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641703|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641704|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641705|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641706|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641707|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641708|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641709|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641751|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose
UT-15C: oral"
644946|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
641721|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641722|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641723|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641724|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641725|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641726|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641727|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641728|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641729|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641730|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641731|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641732|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641733|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641734|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641735|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641736|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641737|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
641738|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
641739|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
641740|NCT01104701|E4|Reported Event|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
641741|NCT01104701|E3|Reported Event|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. .
641742|NCT01104701|E2|Reported Event|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
641743|NCT01104701|E1|Reported Event|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC).
641744|NCT01104870|B4|Baseline|Total|Total of all reporting groups
641745|NCT01104870|B3|Baseline|Dose Group 3|"individual Maximum Tolerated Dose
UT-15C: oral"
641746|NCT01104870|B2|Baseline|Dose Group 2|"1.25 mg twice daily
UT-15C: oral"
641747|NCT01104870|B1|Baseline|Dose Group 1|"0.25 mg twice daily
UT-15C: oral"
644947|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
641761|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily
UT-15C: oral"
641762|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily
UT-15C: oral"
641763|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose
UT-15C: oral"
641764|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily
UT-15C: oral"
641765|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily
UT-15C: oral"
641766|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose
UT-15C: oral"
641767|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily
UT-15C: oral"
641768|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily
UT-15C: oral"
641769|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose
UT-15C: oral"
641770|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily
UT-15C: oral"
641771|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily
UT-15C: oral"
641772|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose
UT-15C: oral"
641773|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily
UT-15C: oral"
641774|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily
UT-15C: oral"
641775|NCT01104870|E3|Reported Event|Dose Group 3|"individual Maximum Tolerated Dose
UT-15C: oral"
641776|NCT01104870|E2|Reported Event|Dose Group 2|"1.25 mg twice daily
UT-15C: oral"
641777|NCT01104870|E1|Reported Event|Dose Group 1|"0.25 mg twice daily
UT-15C: oral"
641832|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules
Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
641778|NCT01105065|B1|Baseline|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.
Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
641779|NCT01105065|P1|Participant Flow|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.
Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
641780|NCT01105065|O2|Outcome|RVD Patients Post-brimonidine Treatment|Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients after their treatment with brimonidine.
641781|NCT01105065|O1|Outcome|RVD Patients Pre-brimonidine Treatment|Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients before their treatment with brimonidine.
641782|NCT01105065|O1|Outcome|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.
Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
641783|NCT01105065|E1|Reported Event|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.
Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
641784|NCT01105091|B3|Baseline|Total|Total of all reporting groups
641785|NCT01105091|B2|Baseline|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
641786|NCT01105091|B1|Baseline|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641787|NCT01105091|P2|Participant Flow|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
641788|NCT01105091|P1|Participant Flow|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641789|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
641790|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641791|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
641792|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641793|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
641794|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641795|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
643973|NCT01112059|O2|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
641796|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641797|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
641798|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641799|NCT01105091|O2|Outcome|Flolan (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641800|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641801|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
641802|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641803|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
641804|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641805|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
641806|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641807|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
641808|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641809|NCT01105091|E2|Reported Event|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
641810|NCT01105091|E1|Reported Event|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
641811|NCT01105117|B3|Baseline|Total|Total of all reporting groups
641812|NCT01105117|B2|Baseline|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®
Flolan® : per Prescribing Information"
641813|NCT01105117|B1|Baseline|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)
ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
641814|NCT01105117|P2|Participant Flow|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®
Flolan® : per Prescribing Information"
641815|NCT01105117|P1|Participant Flow|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)
ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
641816|NCT01105117|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®
Flolan® : per Prescribing Information"
641817|NCT01105117|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)
ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
641818|NCT01105117|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®
Flolan® : per Prescribing Information"
641819|NCT01105117|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)
ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
641820|NCT01105117|E2|Reported Event|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®
Flolan® : per Prescribing Information"
641821|NCT01105117|E1|Reported Event|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)
ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
641822|NCT01105130|B4|Baseline|Total|Total of all reporting groups
641823|NCT01105130|B3|Baseline|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules
Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
641930|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
641824|NCT01105130|B2|Baseline|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
Placebo: Given orally
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
641825|NCT01105130|B1|Baseline|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).
Placebo: Given orally"
641826|NCT01105130|P3|Participant Flow|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules
Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
641827|NCT01105130|P2|Participant Flow|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
Placebo: Given orally
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
641828|NCT01105130|P1|Participant Flow|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).
Placebo: Given orally"
641829|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules
Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
641830|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
Placebo: Given orally
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
641831|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).
Placebo: Given orally"
641833|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
Placebo: Given orally
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
641834|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).
Placebo: Given orally"
641835|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules
Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
641836|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
Placebo: Given orally
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
641837|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).
Placebo: Given orally"
641838|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules
Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
641839|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
Placebo: Given orally
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
641840|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).
Placebo: Given orally"
641841|NCT01105130|E3|Reported Event|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules
Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
641842|NCT01105130|E2|Reported Event|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
Placebo: Given orally
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
641843|NCT01105130|E1|Reported Event|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).
Placebo: Given orally"
641844|NCT01105247|B3|Baseline|Total|Total of all reporting groups
641845|NCT01105247|B2|Baseline|Food Effect Cohort|PCI-32765: 420 mg daily
641846|NCT01105247|B1|Baseline|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
641847|NCT01105247|P2|Participant Flow|Food Effect Cohort|PCI-32765: 420 mg daily
641848|NCT01105247|P1|Participant Flow|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily.
641849|NCT01105247|O3|Outcome|Food Effect|Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
641850|NCT01105247|O2|Outcome|Relapsed/ Refractory|PCI-32765: 420 mg daily or 840 mg daily
641851|NCT01105247|O1|Outcome|Treatment Naive|PCI-32765: 420 mg daily or 840 mg daily
641852|NCT01105247|O3|Outcome|Food- Effect|Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
641853|NCT01105247|O2|Outcome|Relapsed/ Refractory|PCI-32765: 420 mg daily or 840 mg daily
641854|NCT01105247|O1|Outcome|Treatment Naive|PCI-32765: 420 mg daily or 840 mg daily
641855|NCT01105247|O1|Outcome|Food Effect Cohort|PCI-32765: 420 mg daily
641856|NCT01105247|O2|Outcome|Food Effect|Food-Effect Relapsed/Refractory participants received PCI-32765 420 mg daily
641857|NCT01105247|O1|Outcome|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
641858|NCT01105247|E2|Reported Event|Food Effect|PCI-32765: 420 mg daily
641859|NCT01105247|E1|Reported Event|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
641860|NCT01105312|B4|Baseline|Total|Total of all reporting groups
641861|NCT01105312|B3|Baseline|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641862|NCT01105312|B2|Baseline|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641863|NCT01105312|B1|Baseline|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641864|NCT01105312|P3|Participant Flow|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
644948|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
641865|NCT01105312|P2|Participant Flow|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641866|NCT01105312|P1|Participant Flow|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641867|NCT01105312|O2|Outcome|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641868|NCT01105312|O1|Outcome|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641869|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641870|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641871|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641872|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641873|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641874|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641875|NCT01105312|O1|Outcome|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641876|NCT01105312|O2|Outcome|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641877|NCT01105312|O1|Outcome|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641878|NCT01105312|E3|Reported Event|Phase I: Dose Level Two|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641879|NCT01105312|E2|Reported Event|Phase I: Dose Level One|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641880|NCT01105312|E1|Reported Event|Phase II|Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.
641881|NCT01105377|B3|Baseline|Total|Total of all reporting groups
641882|NCT01105377|B2|Baseline|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
641883|NCT01105377|B1|Baseline|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
641884|NCT01105377|P2|Participant Flow|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
641885|NCT01105377|P1|Participant Flow|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
641886|NCT01105377|O2|Outcome|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
641887|NCT01105377|O1|Outcome|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
641888|NCT01105377|O2|Outcome|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
641889|NCT01105377|O1|Outcome|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
641890|NCT01105377|E2|Reported Event|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
641891|NCT01105377|E1|Reported Event|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
644647|NCT01114893|O4|Outcome|Travoprost Group B|
641892|NCT01105533|B1|Baseline|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
641893|NCT01105533|P9|Participant Flow|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
641894|NCT01105533|P8|Participant Flow|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
641895|NCT01105533|P7|Participant Flow|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
641896|NCT01105533|P6|Participant Flow|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
641897|NCT01105533|P5|Participant Flow|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
641898|NCT01105533|P4|Participant Flow|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
641899|NCT01105533|P3|Participant Flow|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
641900|NCT01105533|P2|Participant Flow|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
641901|NCT01105533|P1|Participant Flow|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
641902|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
641903|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
641904|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
641905|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
641906|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
641907|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
641908|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
641909|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
641910|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
641911|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
641912|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
641913|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
641914|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
641915|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
641916|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
641917|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
641918|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
641919|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
641920|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
641921|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
641922|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
641923|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
641924|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
641925|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
641926|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
641927|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
641928|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
641929|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
641931|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
641932|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
641933|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
641934|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
641935|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
641936|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
641937|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
641938|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
641939|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
641940|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
641941|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
641942|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
641943|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
642220|NCT01106287|O5|Outcome|MK-0941 140 mg|All participants receiving a 140-mg dose of MK-0941
641947|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
641948|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
641949|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
641950|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
641951|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
641952|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
641953|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
641954|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
641955|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
641956|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
641957|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
641958|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
641959|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
641960|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
641961|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
641962|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
641963|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
641964|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
641965|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
641966|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
641967|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
641968|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
641969|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
641970|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
641971|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
641972|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
641973|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
641974|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
641975|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
641976|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
641977|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
641978|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
641979|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
641980|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
641981|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
641982|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
641983|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
641984|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
641985|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
641986|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
641987|NCT01105533|E1|Reported Event|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
641988|NCT01105650|B4|Baseline|Total|Total of all reporting groups
641989|NCT01105650|B3|Baseline|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
642038|NCT01105767|O1|Outcome|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic (TMC). High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
644648|NCT01114893|O3|Outcome|Travoprost Group A|
641990|NCT01105650|B2|Baseline|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
641991|NCT01105650|B1|Baseline|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
641992|NCT01105650|P4|Participant Flow|Arm 4: CsA/no Methylprednisolone/3 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin-2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 3 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 3 million units/m^2 3 times per week for 3 doses)."
641993|NCT01105650|P3|Participant Flow|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
641994|NCT01105650|P2|Participant Flow|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
641995|NCT01105650|P1|Participant Flow|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
641996|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
642035|NCT01105767|P1|Participant Flow|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard standard Environmental Protection Agency registered disinfectants.
641997|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
641998|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
642066|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
644649|NCT01114893|O2|Outcome|Travoprost Vehicle|
641999|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
642000|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
642001|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
642002|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
642003|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
642004|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
642005|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
642017|NCT01105702|E1|Reported Event|TBL/RT|"Cycle 1(One 42-day cycle)
Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment
Radiation within 3-5 weeks of surgery
Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks
Treatment Cycles 2-7 (28 days per cycle)
Temozolomide at a dose of 150 mg/m^2 on Days 1-7
Bevacizumab 10 mg/kg on Day 8 and Day 22
Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
642018|NCT01105754|B3|Baseline|Total|Total of all reporting groups
642006|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
642007|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
642008|NCT01105650|E3|Reported Event|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
642009|NCT01105650|E2|Reported Event|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
642010|NCT01105650|E1|Reported Event|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
642011|NCT01105702|B1|Baseline|TBL/RT|"Cycle 1(One 42-day cycle)
Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment
Radiation within 3-5 weeks of surgery
Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks
Treatment Cycles 2-7 (28 days per cycle)
Temozolomide at a dose of 150 mg/m^2 on Days 1-7
Bevacizumab 10 mg/kg on Day 8 and Day 22
Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
642012|NCT01105702|P1|Participant Flow|TBL/RT|"Cycle 1(One 42-day cycle)
Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment
Radiation within 3-5 weeks of surgery
Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks
Treatment Cycles 2-7 (28 days per cycle)
Temozolomide at a dose of 150 mg/m^2 on Days 1-7
Bevacizumab 10 mg/kg on Day 8 and Day 22
Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
642013|NCT01105702|O2|Outcome|Grade 4|"Cycle 1(One 42-day cycle)
Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment
Radiation within 3-5 weeks of surgery
Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks
Treatment Cycles 2-7 (28 days per cycle)
Temozolomide at a dose of 150 mg/m^2 on Days 1-7
Bevacizumab 10 mg/kg on Day 8 and Day 22
Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
642014|NCT01105702|O1|Outcome|Grade 3|"Cycle 1(One 42-day cycle)
Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment
Radiation within 3-5 weeks of surgery
Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks
Treatment Cycles 2-7 (28 days per cycle)
Temozolomide at a dose of 150 mg/m^2 on Days 1-7
Bevacizumab 10 mg/kg on Day 8 and Day 22
Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
642015|NCT01105702|O1|Outcome|TBL/RT|"Cycle 1(One 42-day cycle)
Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment
Radiation within 3-5 weeks of surgery
Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks
Treatment Cycles 2-7 (28 days per cycle)
Temozolomide at a dose of 150 mg/m^2 on Days 1-7
Bevacizumab 10 mg/kg on Day 8 and Day 22
Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
642016|NCT01105702|O1|Outcome|TBL/RT|"Cycle 1(One 42-day cycle)
Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment
Radiation within 3-5 weeks of surgery
Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks
Treatment Cycles 2-7 (28 days per cycle)
Temozolomide at a dose of 150 mg/m^2 on Days 1-7
Bevacizumab 10 mg/kg on Day 8 and Day 22
Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
642050|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
642051|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
642019|NCT01105754|B2|Baseline|Intervention|"Multifaceted Prompting Intervention
Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
642020|NCT01105754|B1|Baseline|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
642039|NCT01105767|O3|Outcome|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
642021|NCT01105754|P2|Participant Flow|Intervention|"Multifaceted Prompting Intervention
Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
642022|NCT01105754|P1|Participant Flow|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
642023|NCT01105754|O2|Outcome|Intervention|"Multifaceted Prompting Intervention
Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
642024|NCT01105754|O1|Outcome|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
642025|NCT01105754|O2|Outcome|Intervention|"Multifaceted Prompting Intervention
Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
642026|NCT01105754|O1|Outcome|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
642027|NCT01105754|E2|Reported Event|Intervention|"Multifaceted Prompting Intervention
Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
642028|NCT01105754|E1|Reported Event|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
642029|NCT01105767|B4|Baseline|Total|Total of all reporting groups
642030|NCT01105767|B3|Baseline|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
642031|NCT01105767|B2|Baseline|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
642032|NCT01105767|B1|Baseline|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency registered disinfectants.
642033|NCT01105767|P3|Participant Flow|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
642034|NCT01105767|P2|Participant Flow|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
642036|NCT01105767|O3|Outcome|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
642037|NCT01105767|O2|Outcome|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
642064|NCT01105936|O1|Outcome|Paracetamol 665 Milligram (mg)|Participants took two 665 mg Paracetamol sustained release caplets orally with 150mL of water.
642040|NCT01105767|O2|Outcome|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
642041|NCT01105767|O1|Outcome|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic (TMC). High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
642042|NCT01105767|E3|Reported Event|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
642043|NCT01105767|E2|Reported Event|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
642044|NCT01105767|E1|Reported Event|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
642045|NCT01105936|B1|Baseline|Total Participants for Baseline Measurement|All randomized participants except one were evaluated for baseline measures. One participant had misallocated treatments that could not be determined. Therefore, this participant was excluded from all populations including safety.
642046|NCT01105936|P4|Participant Flow|Sequence 4|Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
642047|NCT01105936|P3|Participant Flow|Sequence 3|Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered.A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
642048|NCT01105936|P2|Participant Flow|Sequence 2|Participants took part in 3 study sessions. Session 1-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
642049|NCT01105936|P1|Participant Flow|Sequence 1|Participants took part in 3 study sessions. Session 1-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
642052|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
642053|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
642054|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
642055|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
642056|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
642057|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
642058|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
642059|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
642060|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
642061|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
642062|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
642063|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
642065|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
642067|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
642068|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
642069|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
642070|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
642071|NCT01105936|E3|Reported Event|No Treatment|No treatment was given to participants.
642072|NCT01105936|E2|Reported Event|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
642073|NCT01105936|E1|Reported Event|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
642074|NCT01106014|B3|Baseline|Total|Total of all reporting groups
642075|NCT01106014|B2|Baseline|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
642076|NCT01106014|B1|Baseline|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues.
642077|NCT01106014|P2|Participant Flow|PLACEBO|Matching placebo was administered orally following the same administration schedule as described for selexipag
642078|NCT01106014|P1|Participant Flow|SELEXIPAG|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues.
642079|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
642080|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
642081|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
642082|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
642083|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
642084|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
642085|NCT01106014|E2|Reported Event|Placebo|This group includes patients who received at least one dose of placebo. Four patients who were randomized to placebo never received the drugs and another patient received selexipag by mistake (see Selexipag group for more details). Therefore, these patients were excluded from the placebo group in the safety analysis set.
642316|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642086|NCT01106014|E1|Reported Event|Selexipag|This group includes patients who received at least one dose of selexipag. One subject who was randomized to placebo received a single dose of 8 tablets of selexipag due to an error in the dispensation of the medication bottle. Therefore, this patient was assigned to the selexipag group in the safety analysis set.
642087|NCT01106040|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
642088|NCT01106040|P1|Participant Flow|Lymphoseek, Lymphatic Mapping, Injection|Melanoma and breast cancer patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
642089|NCT01106040|O1|Outcome|Reverse Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
642090|NCT01106040|O1|Outcome|Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
642091|NCT01106040|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
642092|NCT01106092|B5|Baseline|Total|Total of all reporting groups
642093|NCT01106092|B4|Baseline|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642212|NCT01106287|B3|Baseline|MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg|Treatment Sequence 3
642213|NCT01106287|B2|Baseline|MK-0941 60/80/Pbo/ MK-0941 120/140 mg|Treatment Sequence 2
642094|NCT01106092|B3|Baseline|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642095|NCT01106092|B2|Baseline|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642096|NCT01106092|B1|Baseline|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642097|NCT01106092|P4|Participant Flow|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642098|NCT01106092|P3|Participant Flow|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642099|NCT01106092|P2|Participant Flow|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642100|NCT01106092|P1|Participant Flow|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642101|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642102|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642103|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642104|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642105|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642106|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642107|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
643974|NCT01112059|O1|Outcome|Placebo|"placebo: placebo
No SAEs noted in this group, 4 total AEs recorded."
642108|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642109|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642110|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642111|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642214|NCT01106287|B1|Baseline|MK-0941 60/80/100/120 mg/Pbo|Treatment Sequence 1
642215|NCT01106287|P4|Participant Flow|Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg|Treatment Sequence 4
644650|NCT01114893|O1|Outcome|Travatan 0.004% QD|
642112|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642113|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642114|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642115|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642116|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642117|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642118|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642119|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642120|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642121|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642122|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642123|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642124|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642125|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642126|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642127|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642128|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642129|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642130|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642131|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642132|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642133|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642134|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642135|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642136|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642137|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642138|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642139|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642140|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642141|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642142|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642143|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642144|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642145|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642146|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642147|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642148|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642149|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642150|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642151|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642152|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642153|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642154|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642155|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642156|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642157|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642158|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642159|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642160|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642161|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642162|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642163|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642164|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
644949|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
642165|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642166|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642167|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642168|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642169|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642170|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642171|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642172|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642173|NCT01106092|E4|Reported Event|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
642174|NCT01106092|E3|Reported Event|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642175|NCT01106092|E2|Reported Event|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642176|NCT01106092|E1|Reported Event|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
642177|NCT01106157|B3|Baseline|Total|Total of all reporting groups
642178|NCT01106157|B2|Baseline|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642179|NCT01106157|B1|Baseline|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642180|NCT01106157|P2|Participant Flow|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner.
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes."
642181|NCT01106157|P1|Participant Flow|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose) given subcutaneously every 2 weeks beginning after the ATG infusion."
642182|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642183|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642364|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
642184|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642185|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642186|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642187|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642188|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642189|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642190|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642191|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642192|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642193|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642194|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642195|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642196|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642197|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642198|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642199|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642200|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642201|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642202|NCT01106157|E2|Reported Event|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
642203|NCT01106157|E1|Reported Event|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.
Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
642204|NCT01106248|B1|Baseline|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
642205|NCT01106248|P1|Participant Flow|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
642206|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
642207|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
642208|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
642209|NCT01106248|E1|Reported Event|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
642210|NCT01106287|B5|Baseline|Total|Total of all reporting groups
642211|NCT01106287|B4|Baseline|Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg|Treatment Sequence 4
642221|NCT01106287|O4|Outcome|MK-0941 120 mg|All participants receiving a 120-mg dose of MK-0941
642222|NCT01106287|O3|Outcome|MK-0941 100 mg|All participants receiving a 100-mg dose of MK-0941
642223|NCT01106287|O2|Outcome|MK-0941 80 mg|All participants receiving a 80-mg dose of MK-0941
642224|NCT01106287|O1|Outcome|MK-0941 60 mg|All participants receiving a 60-mg dose of MK-0941
642225|NCT01106287|O6|Outcome|Placebo|All participants receiving placebo
642226|NCT01106287|O5|Outcome|MK-0941 140 mg|All participants receiving a 140-mg dose of MK-0941
642227|NCT01106287|O4|Outcome|MK-0941 120 mg|All participants receiving a 120-mg dose of MK-0941
642228|NCT01106287|O3|Outcome|MK-0941 100 mg|All participants receiving a 100-mg dose of MK-0941
642229|NCT01106287|O2|Outcome|MK-0941 80 mg|All participants receiving a 80-mg dose of MK-0941
642230|NCT01106287|O1|Outcome|MK-0941 60 mg|All participants receiving a 60-mg dose of MK-0941
642231|NCT01106287|E6|Reported Event|Placebo|All participants receiving placebo
642232|NCT01106287|E5|Reported Event|MK-0941 140 mg|All participants receiving at least one dose of 140 mg of MK-0941
642233|NCT01106287|E4|Reported Event|MK-0941 120 mg|All participants receiving at least one dose of 120 mg of MK-0941
642234|NCT01106287|E3|Reported Event|MK-0941 100 mg|All participants receiving at least one dose of 100 mg of MK-0941
642235|NCT01106287|E2|Reported Event|MK-0941 80 mg|All participants receiving at least one dose of 80 mg of MK-0941
642236|NCT01106287|E1|Reported Event|MK-0941 60 mg|All participants receiving at least one dose of 60 mg of MK-0941
642237|NCT01106326|B1|Baseline|Intervention|"Teens participating in this study will have:
directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study
three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
642238|NCT01106326|P1|Participant Flow|Intervention|"Teens participating in this study will have:
directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study
three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
642239|NCT01106326|O3|Outcome|Four Months Post Baseline|
642240|NCT01106326|O2|Outcome|Two Months Post Baseline|
642241|NCT01106326|O1|Outcome|Baseline|
642242|NCT01106326|E1|Reported Event|Intervention|"Teens participating in this study will have:
directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study
three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
642243|NCT01106352|B6|Baseline|Total|Total of all reporting groups
642244|NCT01106352|B5|Baseline|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642245|NCT01106352|B4|Baseline|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642246|NCT01106352|B3|Baseline|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642365|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
642247|NCT01106352|B2|Baseline|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642248|NCT01106352|B1|Baseline|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642249|NCT01106352|P5|Participant Flow|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642250|NCT01106352|P4|Participant Flow|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642251|NCT01106352|P3|Participant Flow|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642252|NCT01106352|P2|Participant Flow|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642253|NCT01106352|P1|Participant Flow|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642254|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642255|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642256|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642257|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642258|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642259|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642260|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642261|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642262|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642263|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642264|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642265|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642266|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642267|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642268|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642269|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642270|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642271|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642272|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642605|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642273|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642274|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642275|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642276|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642277|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642278|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642279|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642280|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642281|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642282|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642283|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642284|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642285|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642286|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642287|NCT01106352|O3|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642288|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642289|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642290|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642291|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642292|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642293|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642366|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
642294|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642295|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642296|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642297|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642298|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642299|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642300|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642445|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642301|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642302|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642303|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642304|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642305|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642306|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642307|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642308|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642309|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642310|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642311|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642312|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642313|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642314|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642315|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
644950|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
642317|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642318|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642319|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642320|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642321|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642322|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642446|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642323|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642324|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642325|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
642326|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642327|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642328|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642329|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642330|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642331|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642332|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
642333|NCT01106352|E5|Reported Event|Docetaxel 75 mg/m^2 - Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks
642334|NCT01106352|E4|Reported Event|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
642335|NCT01106352|E3|Reported Event|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642336|NCT01106352|E2|Reported Event|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
642367|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
644951|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
642337|NCT01106352|E1|Reported Event|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on National Institute of Standards and Technology (NIST) 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 milligram per square meter (mg/m^2) every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation
642338|NCT01106391|B1|Baseline|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
642339|NCT01106391|P1|Participant Flow|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
642340|NCT01106391|O1|Outcome|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
642341|NCT01106391|O1|Outcome|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
642342|NCT01106391|E1|Reported Event|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
642343|NCT01106404|B3|Baseline|Total|Total of all reporting groups
642344|NCT01106404|B2|Baseline|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
642345|NCT01106404|B1|Baseline|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
642346|NCT01106404|P2|Participant Flow|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
642347|NCT01106404|P1|Participant Flow|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
642348|NCT01106404|O4|Outcome|NPRS at 16 Weeks Post-implant|Included subjects with NPRS scores from both baseline and 16 weeks post-implant
642349|NCT01106404|O3|Outcome|NPRS at Baseline (Subject With Score at 16 Weeks Post-implant)|Included subjects with NPRS scores from both baseline and 16 weeks post-implant
642350|NCT01106404|O2|Outcome|NPRS at 10 Weeks Post-implant|Included subjects with NPRS scores from both baseline and 10 weeks post-implant
642351|NCT01106404|O1|Outcome|NPRS at Baseline (Subject With Score at 10 Weeks Post-implant)|Included subjects with NPRS scores from both baseline and 10 weeks post-implant
642352|NCT01106404|O2|Outcome|Manual Treatment Arm|Subjects in manual treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim OFF.
642353|NCT01106404|O1|Outcome|AdaptiveStim Treatment Arm|Subjects in AdaptiveStim treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim ON.
642354|NCT01106404|O2|Outcome|6-week Manual Followed by 6-week AdaptiveStime Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
642355|NCT01106404|O1|Outcome|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
642356|NCT01106404|O2|Outcome|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
642357|NCT01106404|O1|Outcome|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
642358|NCT01106404|E1|Reported Event|Overall Adverse Events|Overall adverse events were reported.
642359|NCT01106430|B3|Baseline|Total|Total of all reporting groups
642360|NCT01106430|B2|Baseline|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
642361|NCT01106430|B1|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
642362|NCT01106430|P2|Participant Flow|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
642363|NCT01106430|P1|Participant Flow|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
642606|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642368|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
642369|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
642370|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
642371|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
642372|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
642373|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
642374|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
642375|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
642376|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
642377|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
642378|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
642379|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
642380|NCT01106430|E2|Reported Event|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
642381|NCT01106430|E1|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
642382|NCT01106456|B3|Baseline|Total|Total of all reporting groups
642383|NCT01106456|B2|Baseline|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
642384|NCT01106456|B1|Baseline|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)"
642385|NCT01106456|P2|Participant Flow|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
642386|NCT01106456|P1|Participant Flow|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)"
642387|NCT01106456|O2|Outcome|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
642388|NCT01106456|O1|Outcome|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)."
642389|NCT01106456|E2|Reported Event|Experimental 2: Nontailored Program (NT)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored All Nations Breath of Life program (ANBL) or Nontailored program (NT).
Experimental 2: Nontailored program (NT): The nontailored intervention includes the medicines listed above to all participants and targeted counseling delivered by non-American Indian counselors who have worked closely with the American Indian communities and respect the cultures, values, and traditions of the Indian people. Therefore, our intervention includes the current best practice recommendations for smoking cessation. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence.
Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)"
642390|NCT01106456|E1|Reported Event|Experimental 1: All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored All Nations Breath of Life program (ANBL) or Nontailored program (NT).
Experimental 1: All Nations Breath of Life program (ANBL): ANBL consists of in-person group sessions and individual telephone calls. We have successfully conducted a pilot study of ANBL and have found very promising results. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence.
Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)"
642391|NCT01106534|B1|Baseline|Second Enrollment Phase of XIENCE V® USA|"Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - severe or moderate by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular."
642392|NCT01106534|P1|Participant Flow|Second Enrollment Phase of XIENCE V® USA|"Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - severe or moderate by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular."
642393|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin
clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
642394|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin
placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
642395|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin
clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
642396|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin
placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
642397|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin
clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
642398|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin
placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
642399|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin
clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
642400|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin
placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
642401|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin
clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
642402|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin
placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
642403|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin
clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
642434|NCT01106625|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642404|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin
placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
642405|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin
clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
642406|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin
placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
642407|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin
clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
642848|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
642408|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin
placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
642409|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin
clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
642410|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin
placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
642411|NCT01106534|E1|Reported Event|Second Enrollment Phase of XIENCE V® USA|The participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
642412|NCT01106586|B3|Baseline|Total|Total of all reporting groups
642413|NCT01106586|B2|Baseline|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
642414|NCT01106586|B1|Baseline|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
642415|NCT01106586|P2|Participant Flow|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
642416|NCT01106586|P1|Participant Flow|Stribild|Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) plus placebo to match atazanavir/ritonavir (ATV/r) + FTC/TDF once daily
642417|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
642418|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
642419|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
642420|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
642421|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
642422|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
642423|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
642424|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
642425|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
642426|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
642427|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
642428|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
642429|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
642430|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
642431|NCT01106586|E2|Reported Event|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
642432|NCT01106586|E1|Reported Event|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
642433|NCT01106625|B4|Baseline|Total|Total of all reporting groups
642675|NCT01106911|P1|Participant Flow|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
642435|NCT01106625|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642436|NCT01106625|B1|Baseline|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642437|NCT01106625|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642438|NCT01106625|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642439|NCT01106625|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642440|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642441|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642442|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642443|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642444|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
644651|NCT01114893|E5|Reported Event|Travoprost Group C|Travoprost Group C
642447|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642448|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642449|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642450|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642451|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642452|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642453|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642454|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642455|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642456|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642457|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642458|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642459|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642460|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
642461|NCT01106625|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
642462|NCT01106625|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
642463|NCT01106625|E4|Reported Event|Placebo: Baseline to Week 52|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
642464|NCT01106625|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
642465|NCT01106625|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
642466|NCT01106625|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
642467|NCT01106651|B4|Baseline|Total|Total of all reporting groups
642468|NCT01106651|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642469|NCT01106651|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642470|NCT01106651|B1|Baseline|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642538|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642471|NCT01106651|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642472|NCT01106651|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642473|NCT01106651|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642474|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642475|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642476|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642477|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642478|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642479|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642480|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
643219|NCT01108081|P4|Participant Flow|Combined Physical Activity/Diet|Combined physical activity and diet
642481|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642482|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642483|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642484|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642485|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642486|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642487|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642488|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642489|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642490|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642491|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642492|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642493|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642494|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642495|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642496|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642497|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642498|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642499|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642500|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642501|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642502|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642503|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642504|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642505|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642506|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642507|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642508|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642509|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642510|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642511|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642512|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642513|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642514|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642515|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
642516|NCT01106651|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
642517|NCT01106651|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
642518|NCT01106651|E4|Reported Event|Placebo: Baseline to Week 104|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104.
642519|NCT01106651|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
642520|NCT01106651|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
642521|NCT01106651|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
642522|NCT01106677|B5|Baseline|Total|Total of all reporting groups
642523|NCT01106677|B4|Baseline|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642524|NCT01106677|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642525|NCT01106677|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642526|NCT01106677|B1|Baseline|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
642527|NCT01106677|P4|Participant Flow|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642528|NCT01106677|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642529|NCT01106677|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642530|NCT01106677|P1|Participant Flow|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
642531|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642532|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642533|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642534|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642535|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642536|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642537|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642539|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642540|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642541|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642542|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642543|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642544|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642545|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642546|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642547|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642548|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642549|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
643381|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
642550|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642551|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642552|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
642553|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642554|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642555|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642556|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
642557|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642558|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642559|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642560|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
642561|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642562|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642563|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642564|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
642565|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642566|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642567|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642568|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
642569|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642570|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642571|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642572|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
642573|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642574|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642575|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642576|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
642577|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642578|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642579|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
642580|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
642581|NCT01106677|E8|Reported Event|Sitagliptin 100mg: Baseline to Week 52|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
642582|NCT01106677|E7|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
642583|NCT01106677|E6|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
642584|NCT01106677|E5|Reported Event|Placebo/Sitagliptin: Baseline to Week 52|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
642585|NCT01106677|E4|Reported Event|Sitagliptin 100 mg: Baseline to Week 26|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
642586|NCT01106677|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
642587|NCT01106677|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
642588|NCT01106677|E1|Reported Event|Placebo/Sitagliptin: Baseline to Week 26|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
642589|NCT01106690|B4|Baseline|Total|Total of all reporting groups
642590|NCT01106690|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642591|NCT01106690|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642592|NCT01106690|B1|Baseline|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
642593|NCT01106690|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642594|NCT01106690|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642595|NCT01106690|P1|Participant Flow|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
642596|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642597|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642598|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
642599|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642600|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642601|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
642602|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642603|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642604|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
643975|NCT01112059|E2|Reported Event|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
642607|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
642608|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642609|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642610|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
642611|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642612|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642613|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
642614|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642615|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
644652|NCT01114893|E4|Reported Event|Travoprost Group B|Travoprost Group B
642616|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
642617|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642618|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
642619|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
642620|NCT01106690|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
642621|NCT01106690|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
642622|NCT01106690|E4|Reported Event|Placebo/Sitagliptin: Baseline to Week 52|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 52.
642623|NCT01106690|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.
642624|NCT01106690|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.
642625|NCT01106690|E1|Reported Event|Placebo/Sitagliptin: Baseline to Week 26|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 26.
642626|NCT01106846|B3|Baseline|Total|Total of all reporting groups
642627|NCT01106846|B2|Baseline|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously
Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
642628|NCT01106846|B1|Baseline|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously
Group A: Saline Group: Saline continuous infusion"
642629|NCT01106846|P2|Participant Flow|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously
Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
642630|NCT01106846|P1|Participant Flow|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously
Group A: Saline Group: Saline continuous infusion"
642631|NCT01106846|O2|Outcome|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously
Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
642632|NCT01106846|O1|Outcome|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously
Group A: Saline Group: Saline continuous infusion"
642633|NCT01106846|E2|Reported Event|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously
Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
642634|NCT01106846|E1|Reported Event|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously
Group A: Saline Group: Saline continuous infusion"
642635|NCT01106859|B1|Baseline|Total Population|All participants in this four-way cross-over study
642636|NCT01106859|P1|Participant Flow|Total Population|All participants in this four-way cross-over study
642637|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
642638|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
642639|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
642640|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
642641|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
642642|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
642643|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
642644|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
642645|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
642646|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
642647|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
642648|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
642649|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
642650|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
642651|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
642652|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
642653|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
642654|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
642655|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
642656|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
642657|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
642658|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
642659|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
642660|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
642661|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
642662|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
642663|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
642664|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
642665|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
642666|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
642667|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
642668|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
642669|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
642670|NCT01106859|E4|Reported Event|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
642671|NCT01106859|E3|Reported Event|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
642672|NCT01106859|E2|Reported Event|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
642673|NCT01106859|E1|Reported Event|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
642674|NCT01106911|B1|Baseline|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
642676|NCT01106911|O1|Outcome|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
642677|NCT01106911|E1|Reported Event|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
642678|NCT01106950|B1|Baseline|Evaluable (Treated) Patients|Patients are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
642679|NCT01106950|P1|Participant Flow|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
642680|NCT01106950|O2|Outcome|Evaluable (Treated) Patients (Expansion=Yes)|KIR mismatched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
642681|NCT01106950|O1|Outcome|Evaluable (Treated) Patients (Expansion=No)|KIR matched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
642682|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
642683|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
642793|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
642684|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
642685|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
642686|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
642687|NCT01106950|E1|Reported Event|Treated Patients|Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
642688|NCT01106976|B1|Baseline|Group 1 Parkinson Disease Subjects|Prospective cohort study. 59 PD patients
642689|NCT01106976|P1|Participant Flow|Group 1 Parkinson Disease Subjects|Prospective cohort study. 59 PD patients; Hoehn and Yahr stage 1-3) underwent [C-11]methyl-4-piperidinyl propionate (PMP) acetylcholinesterase (AChE) brain PET imaging at baseline and at 3-4 year follow-up. AChE PET imaging assesses cholinergic terminal integrity with cortical uptake reflecting largely basal forebrain neuron integrity and thalamic uptake principally reflecting pedunculopontine nucleus integrity.
642690|NCT01106976|O1|Outcome|Parkinson Disease|Prospective cohort study of Parkinson disease subjects.
642691|NCT01106976|E1|Reported Event|Parkinson|Longitudinal cohort
642692|NCT01101308|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
642693|NCT01101308|P2|Participant Flow|Reformulated OXY 10 mg (Wilson) (Reference) First|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received reformulated OXY (Wilson) (Reference) in period 1 and reformulated OXY (Totowa) (Test) in period 2.
642694|NCT01101308|P1|Participant Flow|Reformulated OXY 10 mg (Totowa) (Test) First|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received reformulated OXY (Totowa) (Test) in period 1 and reformulated OXY (Wilson) (Reference)in period 2.
642695|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642696|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642697|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642698|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642699|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642700|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642701|NCT01101308|E3|Reported Event|Prerandomization|
642702|NCT01101308|E2|Reported Event|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642703|NCT01101308|E1|Reported Event|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642704|NCT01101321|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
642705|NCT01101321|P2|Participant Flow|Reformulated OXY (Wilson) (Reference) First|Reformulated OXY 80-mg tablet (Wilson) (Reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Wilson) (Reference) in period 1 and Reformulated OXY (Totowa) (Test) in period 2.
642739|NCT01101477|E2|Reported Event|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642835|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
642706|NCT01101321|P1|Participant Flow|Reformulated OXY (Totowa) (Test) First|Reformulated OXY 80-mg tablet (Totowa)(Test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Totowa) (Test) in period 1 and Reformulated OXY (Wilson) (Reference) in period 2.
642707|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642708|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642709|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642710|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642711|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642712|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
644653|NCT01114893|E3|Reported Event|Travoprost Group A|Travoprost Group A
642713|NCT01101321|E2|Reported Event|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642714|NCT01101321|E1|Reported Event|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
642715|NCT01101464|B3|Baseline|Total|Total of all reporting groups
642716|NCT01101464|B2|Baseline|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days
642717|NCT01101464|B1|Baseline|Asenapine, (3) 5 mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
642718|NCT01101464|P2|Participant Flow|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
642719|NCT01101464|P1|Participant Flow|Asenapine, (3) 5mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days.
642720|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant).
642721|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant).
642722|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
642723|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
642724|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
642725|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
642726|NCT01101464|E2|Reported Event|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
642727|NCT01101464|E1|Reported Event|Asenapine, (3) 5 mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
642728|NCT01101477|B4|Baseline|Total|Total of all reporting groups
642729|NCT01101477|B3|Baseline|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642730|NCT01101477|B2|Baseline|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642731|NCT01101477|B1|Baseline|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642732|NCT01101477|P3|Participant Flow|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642733|NCT01101477|P2|Participant Flow|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642734|NCT01101477|P1|Participant Flow|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642735|NCT01101477|O3|Outcome|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642736|NCT01101477|O2|Outcome|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642737|NCT01101477|O1|Outcome|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642738|NCT01101477|E3|Reported Event|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642832|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
642740|NCT01101477|E1|Reported Event|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
642741|NCT01101542|B1|Baseline|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
642742|NCT01101542|P1|Participant Flow|Cervarix Group|Subjects who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
642743|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
642794|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
642744|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
642745|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
642746|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
642747|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
642748|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
642749|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
642750|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
642751|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
642752|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
642753|NCT01101542|E4|Reported Event|Cervarix Year 6 Group|Subjects enrolled for surveillance Year 6, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
642754|NCT01101542|E3|Reported Event|Cervarix Year 5 Group|Subjects enrolled for surveillance Year 5, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
642755|NCT01101542|E2|Reported Event|Cervarix Year 4 Group|Subjects enrolled for surveillance Year 4, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
642756|NCT01101542|E1|Reported Event|Cervarix Year 3 Group|Subjects enrolled for surveillance Year 3, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
642757|NCT01107197|B3|Baseline|Total|Total of all reporting groups
642833|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
642758|NCT01107197|B2|Baseline|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Control formula : Isonitrogenous isocaloric oral formula"
642759|NCT01107197|B1|Baseline|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
642760|NCT01107197|P2|Participant Flow|Enriched Nutrition Formula|"Patients were given standard diet plus two bottles/day (400 mL) of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements for 8 weeks
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
642761|NCT01107197|P1|Participant Flow|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bottles/day (200 mL each; in 4 boluses [100 mL each] spread throughout the day) of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one for 8 weeks
Control formula : Isonitrogenous isocaloric oral formula"
642762|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Control formula : Isonitrogenous isocaloric oral formula"
642763|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
642764|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Control formula : Isonitrogenous isocaloric oral formula"
642765|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
642766|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Control formula : Isonitrogenous isocaloric oral formula"
642767|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
642768|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Control formula : Isonitrogenous isocaloric oral formula"
642769|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
642770|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Control formula : Isonitrogenous isocaloric oral formula"
642771|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
642772|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Control formula : Isonitrogenous isocaloric oral formula"
642773|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
642774|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Control formula : Isonitrogenous isocaloric oral formula"
642775|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
642776|NCT01107197|E2|Reported Event|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Control formula : Isonitrogenous isocaloric oral formula"
642777|NCT01107197|E1|Reported Event|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
642778|NCT01107353|B3|Baseline|Total|Total of all reporting groups
642779|NCT01107353|B2|Baseline|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
Imipramine Pamoate: 75 mg capsule"
642780|NCT01107353|B1|Baseline|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)
Imipramine Pamoate: 75 mg capsule"
642781|NCT01107353|P2|Participant Flow|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
Imipramine Pamoate: 75 mg capsule"
642782|NCT01107353|P1|Participant Flow|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)
Imipramine Pamoate: 75 mg capsule"
642783|NCT01107353|O2|Outcome|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
Imipramine Pamoate: 75 mg capsule"
642784|NCT01107353|O1|Outcome|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)
Imipramine Pamoate: 75 mg capsule"
642785|NCT01107353|E2|Reported Event|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
Imipramine Pamoate: 75 mg capsule"
642834|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
642786|NCT01107353|E1|Reported Event|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)
Imipramine Pamoate: 75 mg capsule"
642787|NCT01107379|B1|Baseline|Balloon Catheter Device|"Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for sinus dilation"
642788|NCT01107379|P1|Participant Flow|Balloon Device|"Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
642789|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
642790|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
642791|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
642792|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
643382|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
642795|NCT01107379|E1|Reported Event|Balloon Device|"Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
642796|NCT01107392|B3|Baseline|Total|Total of all reporting groups
642797|NCT01107392|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
642798|NCT01107392|B1|Baseline|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
642799|NCT01107392|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
642800|NCT01107392|P1|Participant Flow|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
642801|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
642802|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
642803|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
642804|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
642805|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
642806|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
642807|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
642808|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
642809|NCT01107392|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
642810|NCT01107392|E1|Reported Event|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
642811|NCT01107405|B6|Baseline|Total|Total of all reporting groups
642812|NCT01107405|B5|Baseline|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
642813|NCT01107405|B4|Baseline|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
642814|NCT01107405|B3|Baseline|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
642815|NCT01107405|B2|Baseline|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
642816|NCT01107405|B1|Baseline|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
642817|NCT01107405|P5|Participant Flow|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
642818|NCT01107405|P4|Participant Flow|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
642819|NCT01107405|P3|Participant Flow|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
642820|NCT01107405|P2|Participant Flow|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
642821|NCT01107405|P1|Participant Flow|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
642822|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
642823|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
642824|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
642825|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
642826|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
642827|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
642828|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
642829|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
642830|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
642831|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
642938|NCT01107730|O1|Outcome|L-Carnitine|Carnitine 2 days preoperatively and 4 days postoperatively
642836|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
642837|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
642838|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
642839|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
642840|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
642841|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
642842|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
642843|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
642844|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
642845|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
642846|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
642847|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
643383|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
642849|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
642850|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
642851|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
642852|NCT01107405|E5|Reported Event|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
642853|NCT01107405|E4|Reported Event|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
642854|NCT01107405|E3|Reported Event|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
642855|NCT01107405|E2|Reported Event|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
642856|NCT01107405|E1|Reported Event|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
642857|NCT01107418|B5|Baseline|Total|Total of all reporting groups
642858|NCT01107418|B4|Baseline|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642859|NCT01107418|B3|Baseline|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642860|NCT01107418|B2|Baseline|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642861|NCT01107418|B1|Baseline|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642862|NCT01107418|P1|Participant Flow|Vemurafenib – All Cohorts|Participants received vemurafenib (RO5185426) film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 milligrams (mg) on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642863|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642864|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642865|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642866|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642939|NCT01107730|E3|Reported Event|Placebo|Placebo: Placebo
643018|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642867|NCT01107418|O1|Outcome|Vemurafenib – All Cohorts|Participants received vemurafenib film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642868|NCT01107418|O1|Outcome|Vemurafenib – All Cohorts|Participants received vemurafenib film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642869|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642947|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642948|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642870|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642871|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642872|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642873|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642874|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642875|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642876|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642877|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642878|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642879|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642880|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642881|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642882|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
643976|NCT01112059|E1|Reported Event|Placebo|placebo: placebo
642883|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642884|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642885|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642886|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642887|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642888|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642889|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642890|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642891|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642892|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642893|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642894|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642895|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642896|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642897|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642898|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
643070|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
642899|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642900|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642901|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642902|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642903|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642904|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642905|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642906|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642907|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642908|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642909|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642910|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642911|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642912|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642913|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642914|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
643071|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
642915|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642916|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642917|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642918|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642919|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642920|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642921|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642922|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642923|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642924|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642925|NCT01107418|E4|Reported Event|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642926|NCT01107418|E3|Reported Event|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642927|NCT01107418|E2|Reported Event|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642928|NCT01107418|E1|Reported Event|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
642929|NCT01107730|B4|Baseline|Total|Total of all reporting groups
642930|NCT01107730|B3|Baseline|Placebo|Placebo: Placebo
642931|NCT01107730|B2|Baseline|Vitamin C|Vitamin C 2 days preoperatively and 4 days postoperatively
642932|NCT01107730|B1|Baseline|L-Carnitine|Carnitine 2 days preoperatively and 4 days postoperatively
642933|NCT01107730|P3|Participant Flow|Placebo|Placebo: Placebo
642934|NCT01107730|P2|Participant Flow|Vitamin C|VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days
642935|NCT01107730|P1|Participant Flow|L-Carnitine|L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days
642936|NCT01107730|O3|Outcome|Placebo|Placebo: Placebo
642937|NCT01107730|O2|Outcome|Vitamin C|Vitamin C 2 days preoperatively and 4 days postoperatively
642940|NCT01107730|E2|Reported Event|Vitamin C|"Vitamin C 2 days preoperatively and 4 days postoperatively
Vitamin C: Vitamin C 2 days preoperatively and 4 days postoperatively"
642941|NCT01107730|E1|Reported Event|L-Carnitine|"Carnitine 2 days preoperatively and 4 days postoperatively
Carnitine: Carnitine 2 days preoperatively and 4 days postoperatively"
642942|NCT01107743|B1|Baseline|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642943|NCT01107743|P1|Participant Flow|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642944|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642945|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642946|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642949|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642950|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642951|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642952|NCT01107743|O6|Outcome|Type Ⅴ|Participants with expression type Ⅴ who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
642953|NCT01107743|O5|Outcome|Type Ⅳ|Participants with expression type Ⅳ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642954|NCT01107743|O4|Outcome|Type Ⅲ|Participants with expression type Ⅲ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642955|NCT01107743|O3|Outcome|Type Ⅱb|Participants with expression type Ⅱb who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642956|NCT01107743|O2|Outcome|Type Ⅱa|Participants with expression type Ⅱa who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642957|NCT01107743|O1|Outcome|Type Ⅰ|Participants with expression type Ⅰ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642958|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642959|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642960|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642961|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642962|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642963|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642964|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642965|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642966|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642967|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642968|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642969|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642970|NCT01107743|O4|Outcome|Class4|Participants with Class4 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642971|NCT01107743|O3|Outcome|Class3|Participants with Class3 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642972|NCT01107743|O2|Outcome|Class2|Participants with Class2 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642973|NCT01107743|O1|Outcome|Class1|Participants with Class1 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642974|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642975|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642976|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642977|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642978|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642979|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642980|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642981|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642982|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642983|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642984|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642985|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642986|NCT01107743|O3|Outcome|ClassⅢ|Participants with Class Ⅲ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642987|NCT01107743|O2|Outcome|ClassⅡ|Participants with ClassⅡ Hypertension who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
642988|NCT01107743|O1|Outcome|ClassⅠ|Participants with ClassⅠ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642989|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642990|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642991|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
642992|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
642993|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642994|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642995|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642996|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642997|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642998|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
642999|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643000|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643001|NCT01107743|O2|Outcome|With Familial Hypercholesterolemia|Participants with Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643002|NCT01107743|O1|Outcome|Without Familial Hypercholesterolemia|Participants without Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643003|NCT01107743|O6|Outcome|Type Ⅴ|Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
643004|NCT01107743|O5|Outcome|Type Ⅳ|Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643005|NCT01107743|O4|Outcome|Type Ⅲ|Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643006|NCT01107743|O3|Outcome|Type Ⅱb|Participants with expression type Ⅱb Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643007|NCT01107743|O2|Outcome|Type Ⅱa|Participants with expression type Ⅱa Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643008|NCT01107743|O1|Outcome|Type Ⅰ|Participants with expression type Ⅰ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643009|NCT01107743|O2|Outcome|With Hypercholesterolemia|Participants with Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643010|NCT01107743|O1|Outcome|Without Hypercholesterolemia|Participants without Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643011|NCT01107743|O2|Outcome|With Angina Pectoris|Participants with Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643012|NCT01107743|O1|Outcome|Without Angina Pectoris|Participants without Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643013|NCT01107743|O3|Outcome|ClassⅢ|Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643014|NCT01107743|O2|Outcome|ClassⅡ|Participants with ClassⅡ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643015|NCT01107743|O1|Outcome|ClassⅠ|Participants with ClassⅠ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643016|NCT01107743|O2|Outcome|With Hypertension|Participants with Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643017|NCT01107743|O1|Outcome|Without Hypertension|Participants without Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643072|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643019|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643020|NCT01107743|O2|Outcome|Female|Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643021|NCT01107743|O1|Outcome|Male|Male participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643022|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643023|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643024|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643025|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643026|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643027|NCT01107743|E1|Reported Event|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
643029|NCT01107834|B2|Baseline|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
643030|NCT01107834|B1|Baseline|Healthy Control|HIV-negative children born to healthy, HIV-negative women
643031|NCT01107834|P2|Participant Flow|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
643032|NCT01107834|P1|Participant Flow|Healthy Control|HIV-negative children born to healthy, HIV-negative women
643033|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
643034|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
643035|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
643036|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
643037|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
643038|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
643039|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
643040|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
643041|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
643042|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
643043|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
643044|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
643045|NCT01107834|E2|Reported Event|Exposed to HIV/HAART|"HIV-negative children exposed to HIV and HAART in utero
No adverse events"
643046|NCT01107834|E1|Reported Event|Healthy Control|"HIV-negative children born to healthy, HIV-negative women
No adverse events"
643047|NCT01107886|B3|Baseline|Total|Total of all reporting groups
643048|NCT01107886|B2|Baseline|Placebo|Matching Placebo
643049|NCT01107886|B1|Baseline|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
643050|NCT01107886|P2|Participant Flow|Placebo|Matching Placebo
643051|NCT01107886|P1|Participant Flow|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
643052|NCT01107886|O2|Outcome|Placebo|Matching Placebo
643053|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
643054|NCT01107886|O2|Outcome|Placebo|Matching Placebo
643055|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
643056|NCT01107886|O2|Outcome|Placebo|Matching Placebo
643057|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
643058|NCT01107886|E2|Reported Event|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
643059|NCT01107886|E1|Reported Event|Placebo|Matching Placebo
643060|NCT01107899|B4|Baseline|Total|Total of all reporting groups
643061|NCT01107899|B3|Baseline|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643062|NCT01107899|B2|Baseline|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643063|NCT01107899|B1|Baseline|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643064|NCT01107899|P3|Participant Flow|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643065|NCT01107899|P2|Participant Flow|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643066|NCT01107899|P1|Participant Flow|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643067|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643068|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643069|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643073|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643074|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643075|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643076|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643077|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643078|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643079|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643080|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643081|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643082|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643083|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643084|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643085|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643086|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643087|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643088|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643089|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643090|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643091|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643092|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643093|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643094|NCT01107899|O1|Outcome|All Treatments|"Clopidogrel 600 mg taken orally, day one, single dose Prasugrel 30 and 60 mg taken orally, day one, single dose
All treatments were combined into one group."
643095|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643096|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643097|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643098|NCT01107899|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643099|NCT01107899|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643100|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643101|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643102|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643103|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643104|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643105|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643106|NCT01107899|E3|Reported Event|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
643107|NCT01107899|E2|Reported Event|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
643108|NCT01107899|E1|Reported Event|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
643109|NCT01107912|B5|Baseline|Total|Total of all reporting groups
643110|NCT01107912|B4|Baseline|Non-Elderly; Drug Sequence BCA|Participants (≥45 to <65 years of age) in this arm received study drug sequence BCA. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
643111|NCT01107912|B3|Baseline|Non-Elderly; Drug Sequence BAC|Participants (≥45 to <65 years of age) in this arm received study drug sequence BAC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
643112|NCT01107912|B2|Baseline|Very Elderly; Drug Sequence ACB|Participants (≥75 years of age) in this arm received study drug sequence ACB. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
643113|NCT01107912|B1|Baseline|Very Elderly, Drug Sequence ABC|Participants (≥75 years of age) in this arm received study drug sequence ABC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
643114|NCT01107912|P6|Participant Flow|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643115|NCT01107912|P5|Participant Flow|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643116|NCT01107912|P4|Participant Flow|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
643117|NCT01107912|P3|Participant Flow|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643118|NCT01107912|P2|Participant Flow|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
643119|NCT01107912|P1|Participant Flow|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643120|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643121|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643122|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
643123|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643124|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
643125|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643126|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643220|NCT01108081|P3|Participant Flow|Health Education|"Health education
Health education: Attention control intervention"
643127|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643128|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
643129|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643130|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
643131|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643132|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643133|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643134|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
643135|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643136|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
643137|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643138|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643139|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643140|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
643141|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643142|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
643143|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643144|NCT01107912|O2|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643145|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643146|NCT01107912|E6|Reported Event|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643147|NCT01107912|E5|Reported Event|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643148|NCT01107912|E4|Reported Event|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
643149|NCT01107912|E3|Reported Event|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
643150|NCT01107912|E2|Reported Event|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
643151|NCT01107912|E1|Reported Event|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
643152|NCT01107925|B5|Baseline|Total|Total of all reporting groups
643153|NCT01107925|B4|Baseline|Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)|Participants in the HBW group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3.
643154|NCT01107925|B3|Baseline|Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)|Participants in the higher body weight (HBW; ≥60 kg) group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3.
643155|NCT01107925|B2|Baseline|Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)|Participants in the LBW group received 5 mg Pras during Study Period 1, followed by 75 mg Clop in Study Period 2, and 10 mg Pras in Study Period 3.
643156|NCT01107925|B1|Baseline|Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)|Participants in the low body weight (LBW; <60 kilograms [kg]) group received 5 milligrams (mg) of Prasugrel (Pras) during Study Period 1, followed by 10 mg Pras in Study Period 2, followed by 75 mg clopidogrel (Clop) in Study Period 3.
643221|NCT01108081|P2|Participant Flow|Diet|"Diet
Diet: Dietary weight loss"
643384|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
643157|NCT01107925|P6|Participant Flow|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643158|NCT01107925|P5|Participant Flow|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
643159|NCT01107925|P4|Participant Flow|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643160|NCT01107925|P3|Participant Flow|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
643161|NCT01107925|P2|Participant Flow|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643162|NCT01107925|P1|Participant Flow|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
643163|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either 5-mg prasugrel or the 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643164|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the (HBW; ≥ 60 kg) treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
643165|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643166|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Period 1 (on 5 mg prasugrel) were switched to either the 10-mg prasugrel or the 75-mg clopidogrel dose for Period 2 or Period 3.
643167|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643168|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
643169|NCT01107925|O6|Outcome|Clopidogrel 75 mg (HBW)|Participants in the HBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643170|NCT01107925|O5|Outcome|Prasugrel 10 mg (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
643171|NCT01107925|O4|Outcome|Prasugrel 5 mg (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643172|NCT01107925|O3|Outcome|Clopidogrel 75 mg (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643173|NCT01107925|O2|Outcome|Prasugrel 10 mg (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643174|NCT01107925|O1|Outcome|Prasugrel 5 mg (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
643175|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose during Study Period 2 or Study Period 3.
643176|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
643177|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643209|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
643178|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
643179|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643180|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; (<60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
643181|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose either during Study Period 2 or Study Period 3.
643182|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
644654|NCT01114893|E2|Reported Event|Travoprost Vehicle|Travoprost Vehicle
643183|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643184|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
643185|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643186|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
643187|NCT01107925|O2|Outcome|Prasugrel 10 mg (HBW)|Participants in the higher body weight (HBW; ≥60 kg) group received the 10-mg prasugrel dose in Study Period 1.
643188|NCT01107925|O1|Outcome|Prasugrel 5 mg (LBW)|Participants in the low body weight (LBW; <60 kilograms [kg]) group received the 5-milligram (mg) prasugrel dose in Study Period 1.
643189|NCT01107925|E6|Reported Event|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643190|NCT01107925|E5|Reported Event|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
643191|NCT01107925|E4|Reported Event|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 mg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643192|NCT01107925|E3|Reported Event|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
643193|NCT01107925|E2|Reported Event|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
643194|NCT01107925|E1|Reported Event|5 mg Prasugrel (LBW)|During Study Period 1, participants received 5 milligrams (mg) prasugrel for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
643195|NCT01108003|B3|Baseline|Total|Total of all reporting groups
643196|NCT01108003|B2|Baseline|Arm 2|"Patients receive mango juice alone.
Mango Juice: given orally"
643197|NCT01108003|B1|Baseline|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
broccoli sprout extract: Given orally
laboratory biomarker analysis: Correlative studies"
643198|NCT01108003|P2|Participant Flow|Arm 2|"Patients receive mango juice alone.
Mango Juice: given orally"
643199|NCT01108003|P1|Participant Flow|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
broccoli sprout extract: Given orally
laboratory biomarker analysis: Correlative studies"
643200|NCT01108003|O2|Outcome|Arm 2|"Patients receive mango juice alone.
Mango Juice: given orally"
643201|NCT01108003|O1|Outcome|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
broccoli sprout extract: Given orally
laboratory biomarker analysis: Correlative studies"
643202|NCT01108003|O2|Outcome|Arm 2|"Patients receive mango juice alone.
Mango Juice: given orally"
643203|NCT01108003|O1|Outcome|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
broccoli sprout extract: Given orally
laboratory biomarker analysis: Correlative studies"
643204|NCT01108003|E2|Reported Event|Arm 2|"Patients receive mango juice alone.
Mango Juice: given orally"
643205|NCT01108003|E1|Reported Event|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
broccoli sprout extract: Given orally
laboratory biomarker analysis: Correlative studies"
643206|NCT01108055|B1|Baseline|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
643207|NCT01108055|P1|Participant Flow|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
643208|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
643330|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643210|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
643211|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
643212|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
643213|NCT01108055|E1|Reported Event|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
643214|NCT01108081|B5|Baseline|Total|Total of all reporting groups
643215|NCT01108081|B4|Baseline|Combined Physical Activity/Diet|Combined physical activity and diet
643216|NCT01108081|B3|Baseline|Health Education|"Health education
Health education: Attention control intervention"
643217|NCT01108081|B2|Baseline|Diet|"Diet
Diet: Dietary weight loss"
643218|NCT01108081|B1|Baseline|Physical Activity|"Physical activity
Physical activity: Moderate-intensity physical activity"
643222|NCT01108081|P1|Participant Flow|Physical Activity|"Physical activity
Physical activity: Moderate-intensity physical activity"
643223|NCT01108081|O4|Outcome|Combined Physical Activity/Diet|Combined physical activity and diet
643224|NCT01108081|O3|Outcome|Health Education|"Health education
Health education: Attention control intervention"
643225|NCT01108081|O2|Outcome|Diet|"Diet
Diet: Dietary weight loss"
643226|NCT01108081|O1|Outcome|Physical Activity|"Physical activity
Physical activity: Moderate-intensity physical activity"
643227|NCT01108081|O4|Outcome|Combined Physical Activity/Diet|Combined physical activity and diet
643228|NCT01108081|O3|Outcome|Health Education|"Health education
Health education: Attention control intervention"
643229|NCT01108081|O2|Outcome|Diet|"Diet
Diet: Dietary weight loss"
643230|NCT01108081|O1|Outcome|Physical Activity|"Physical activity
Physical activity: Moderate-intensity physical activity"
643231|NCT01108081|E4|Reported Event|Combined Physical Activity/Diet|Combined physical activity and diet
643232|NCT01108081|E3|Reported Event|Health Education|"Health education
Health education: Attention control intervention"
643233|NCT01108081|E2|Reported Event|Diet|"Diet
Diet: Dietary weight loss"
643234|NCT01108081|E1|Reported Event|Physical Activity|"Physical activity
Physical activity: Moderate-intensity physical activity"
643235|NCT01108185|B1|Baseline|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643236|NCT01108185|P1|Participant Flow|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643237|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643238|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643239|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643240|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643241|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643242|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643243|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643244|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643245|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643246|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643247|NCT01108185|E1|Reported Event|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
643248|NCT01108237|B3|Baseline|Total|Total of all reporting groups
643249|NCT01108237|B2|Baseline|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
643250|NCT01108237|B1|Baseline|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
643251|NCT01108237|P2|Participant Flow|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
643252|NCT01108237|P1|Participant Flow|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
643253|NCT01108237|O2|Outcome|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
643254|NCT01108237|O1|Outcome|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
643255|NCT01108237|E2|Reported Event|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
643256|NCT01108237|E1|Reported Event|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
643257|NCT01108263|B3|Baseline|Total|Total of all reporting groups
643258|NCT01108263|B2|Baseline|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
643259|NCT01108263|B1|Baseline|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
643260|NCT01108263|P2|Participant Flow|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
643261|NCT01108263|P1|Participant Flow|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
643262|NCT01108263|O2|Outcome|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
643263|NCT01108263|O1|Outcome|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
643264|NCT01108263|O2|Outcome|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
643265|NCT01108263|O1|Outcome|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
643266|NCT01108263|E2|Reported Event|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
643267|NCT01108263|E1|Reported Event|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
643268|NCT01108341|B1|Baseline|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
643269|NCT01108341|P1|Participant Flow|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
643270|NCT01108341|O1|Outcome|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
643271|NCT01108341|O1|Outcome|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
643272|NCT01108341|E1|Reported Event|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
643273|NCT01108406|B1|Baseline|Long Term Safety|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
643274|NCT01108406|P1|Participant Flow|Sonitus SoundBite System|Long Term Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
643275|NCT01108406|O2|Outcome|Global Benefit APHAB Score Aided 6 Months|The Global Benefit APHAB at 6 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 6 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
643331|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643276|NCT01108406|O1|Outcome|Global Benefit APHAB Score Aided 3 Months|The Global Benefit APHAB at 3 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 3 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
643277|NCT01108406|O1|Outcome|Number of Participants Experiencing no Adverse Events|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure. Dental measurements included periodontal measurements (bone loss, oral health, bleeding index, calculus, peridontal probing) at baseline compared to 6 months. Audiological included hearing evaluation and aided thresholds baseline compared to 6 months and medical compared medical and ear health baseline compared to 6 months.
643278|NCT01108406|E1|Reported Event|Long Term Safety|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
643279|NCT01108445|B3|Baseline|Total|Total of all reporting groups
643280|NCT01108445|B2|Baseline|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643281|NCT01108445|B1|Baseline|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643282|NCT01108445|P2|Participant Flow|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643283|NCT01108445|P1|Participant Flow|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643284|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643285|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643286|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643287|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643288|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643289|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643290|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643291|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643292|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643293|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643294|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643295|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643296|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643297|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643298|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643299|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643300|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643332|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643333|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643301|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643302|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643303|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643304|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643305|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643306|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
644655|NCT01114893|E1|Reported Event|TRAVATAN|TRAVATAN 0.004% once daily
643307|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643308|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643309|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643310|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643311|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643312|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643313|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643314|NCT01108445|E2|Reported Event|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
643315|NCT01108445|E1|Reported Event|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
643316|NCT01108458|B1|Baseline|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks
Erlotinib hydrochloride 150 mg/day by mouth
Pertuzumab: iv, 840 mg, 420 mg
Erlotinib: PO, 150 mg"
643317|NCT01108458|P1|Participant Flow|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks
Erlotinib hydrochloride 150 mg/day by mouth
Pertuzumab: iv, 840 mg, 420 mg
Erlotinib: PO, 150 mg"
643318|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks
Erlotinib hydrochloride 150 mg/day by mouth
Pertuzumab: iv, 840 mg, 420 mg
Erlotinib: PO, 150 mg"
643319|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks
Erlotinib hydrochloride 150 mg/day by mouth
Pertuzumab: iv, 840 mg, 420 mg
Erlotinib: PO, 150 mg"
643320|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks
Erlotinib hydrochloride 150 mg/day by mouth
Pertuzumab: iv, 840 mg, 420 mg
Erlotinib: PO, 150 mg"
643321|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks
Erlotinib hydrochloride 150 mg/day by mouth
Pertuzumab: iv, 840 mg, 420 mg
Erlotinib: PO, 150 mg"
643322|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks
Erlotinib hydrochloride 150 mg/day by mouth
Pertuzumab: iv, 840 mg, 420 mg
Erlotinib: PO, 150 mg"
643323|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks
Erlotinib hydrochloride 150 mg/day by mouth
Pertuzumab: iv, 840 mg, 420 mg
Erlotinib: PO, 150 mg"
643324|NCT01108458|E1|Reported Event|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks
Erlotinib hydrochloride 150 mg/day by mouth
Pertuzumab: iv, 840 mg, 420 mg
Erlotinib: PO, 150 mg"
643325|NCT01108510|B3|Baseline|Total|Total of all reporting groups
643326|NCT01108510|B2|Baseline|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643327|NCT01108510|B1|Baseline|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643328|NCT01108510|P2|Participant Flow|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643329|NCT01108510|P1|Participant Flow|ATV+COBI+FTC/TDF|Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily
643334|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643335|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643336|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643337|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643338|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643339|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643340|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643341|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643342|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643343|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643344|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643345|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
644656|NCT01114945|B5|Baseline|Total|Total of all reporting groups
643346|NCT01108510|E2|Reported Event|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643347|NCT01108510|E1|Reported Event|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
643348|NCT01108523|B1|Baseline|HP828-101|HP828-101 Experimental Formulation
643349|NCT01108523|P1|Participant Flow|HP828-101|HP828-101 Experimental Formulation
643350|NCT01108523|O1|Outcome|HP828-101|HP828-101 Experimental Formulation
643351|NCT01108523|O1|Outcome|HP828-101|HP828-101 Experimental Formulation
643352|NCT01108523|E1|Reported Event|HP828-101|HP828-101 Experimental Formulation
643353|NCT01108718|B3|Baseline|Total|Total of all reporting groups
643354|NCT01108718|B2|Baseline|Subjects Who Receive the Control Mattress First(2 Months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.
643355|NCT01108718|B1|Baseline|Subjects Who Receive Tempur-Pedic Mattress First(2 Months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.
643356|NCT01108718|P2|Participant Flow|Subjects Who Received the Control Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first, then the Tempur-pedic mattress.
643357|NCT01108718|P1|Participant Flow|Subjects Who Received the Tempur-Pedic Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first, then the Control Mattress.
643358|NCT01108718|O1|Outcome|All Participants|All subjects used a tempur-pedic mattress and control mattress to sleep on in a cross over design for a period of 2 months per mattress.
643359|NCT01108718|E2|Reported Event|Subjects Who Received the Control Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.
643360|NCT01108718|E1|Reported Event|Subjects Who Received Tempur-Pedic Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.
643361|NCT01108731|B3|Baseline|Total|Total of all reporting groups
643362|NCT01108731|B2|Baseline|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
643363|NCT01108731|B1|Baseline|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
643364|NCT01108731|P2|Participant Flow|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
643365|NCT01108731|P1|Participant Flow|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
643366|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
643367|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
643368|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
643369|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
643370|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
643371|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
644817|NCT01115582|E1|Reported Event|Cholic Acid|All patients entered and treated
643372|NCT01108731|E2|Reported Event|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
643373|NCT01108731|E1|Reported Event|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
643374|NCT01108796|B5|Baseline|Total|Total of all reporting groups
643375|NCT01108796|B4|Baseline|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
643376|NCT01108796|B3|Baseline|Tool (With Lifestyle Education Tool on Weight Reduction)|
643377|NCT01108796|B2|Baseline|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
643378|NCT01108796|B1|Baseline|Micardis® (Telmisartan)|Patients were enrolled into two groups, receiving treatment with Micardis or MicardisPlus and in addition with Tool or No Tool. The system summarizes the number of patients automatically. The total number is always 1841.
643379|NCT01108796|P2|Participant Flow|MicardisPlus® (Telmisartan Hydrochlorothiazide)|These patients in addition received Tool or No Tool treatment
643380|NCT01108796|P1|Participant Flow|Micardis® (Telmisartan)|These patients in addition received Tool or No Tool treatment
643385|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
643386|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
643387|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
643388|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
643389|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
643390|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
643391|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
643392|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
643393|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
643394|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
643395|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
643396|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
643397|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
643398|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
643399|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
643400|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
643401|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
643402|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
643403|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
643404|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
643405|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
643406|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
643407|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
643408|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
643409|NCT01108796|E2|Reported Event|MicardisPlus® (Telmisartan Hydrochlorothiazide)|These patients in addition received Tool or No Tool treatment
643410|NCT01108796|E1|Reported Event|Micardis® (Telmisartan)|These patients in addition received Tool or No Tool treatment
643411|NCT01108809|B1|Baseline|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
643412|NCT01108809|P1|Participant Flow|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
643413|NCT01108809|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
643414|NCT01108809|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
643415|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
643416|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
643417|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
643418|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
643419|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
643420|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
643421|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
643422|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
643423|NCT01108809|E1|Reported Event|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
643424|NCT01108835|B3|Baseline|Total|Total of all reporting groups
643425|NCT01108835|B2|Baseline|Control Group|Control arm with usual care
643426|NCT01108835|B1|Baseline|Comprehensive Care|"Comprehensive care
Comprehensive care programme: Intervention group:
Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
Respiratory physician assessment and optimization of treatment
Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
643427|NCT01108835|P2|Participant Flow|Control Group|Control arm with usual care
643456|NCT01109108|B1|Baseline|Children 0<2 Years of Age|Children 0<2 years of age with and without concurrent respiratory tract infection
643457|NCT01109108|P2|Participant Flow|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
643458|NCT01109108|P1|Participant Flow|Children 0<2 Years of Age|Children 0<2 years of age with and without respiratory tract infection
643428|NCT01108835|P1|Participant Flow|Comprehensive Care|"Comprehensive care
Comprehensive care programme: Intervention group:
Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
Respiratory physician assessment and optimization of treatment
Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
643429|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
643430|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care
Comprehensive care programme: Intervention group:
Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
Respiratory physician assessment and optimization of treatment
Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
643431|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
643471|NCT01109147|O2|Outcome|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
643472|NCT01109147|O1|Outcome|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
643473|NCT01109147|E3|Reported Event|Control|healthy volunteers
644657|NCT01114945|B4|Baseline|McGrath|MacGrath device
643432|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care
Comprehensive care programme: Intervention group:
Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
Respiratory physician assessment and optimization of treatment
Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
643433|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
643434|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care
Comprehensive care programme: Intervention group:
Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
Respiratory physician assessment and optimization of treatment
Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
643435|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
643436|NCT01108835|O1|Outcome|Comprehensive Care Programme|"Comprehensive care involving multidisciplinary input.
Comprehensive care programme: Intervention group:
Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
Respiratory physician assessment and optimization of treatment
Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
643437|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
643438|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care
Comprehensive care programme: Intervention group:
Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
Respiratory physician assessment and optimization of treatment
Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
643439|NCT01108835|E2|Reported Event|Control Group|Control arm with usual care
643440|NCT01108835|E1|Reported Event|Comprehensive Care|"Comprehensive care
Comprehensive care programme: Intervention group:
Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
Respiratory physician assessment and optimization of treatment
Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
643441|NCT01109056|B3|Baseline|Total|Total of all reporting groups
643442|NCT01109056|B2|Baseline|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
643443|NCT01109056|B1|Baseline|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
643444|NCT01109056|P2|Participant Flow|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
643445|NCT01109056|P1|Participant Flow|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
643446|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
643447|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
643448|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
643449|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
643450|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
643451|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
643452|NCT01109056|E2|Reported Event|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
643453|NCT01109056|E1|Reported Event|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
643454|NCT01109108|B3|Baseline|Total|Total of all reporting groups
643455|NCT01109108|B2|Baseline|Children 2<5 Years of Age|Children 2<5 years of age with and without concurrent respiratory tract infection
643459|NCT01109108|O2|Outcome|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
643460|NCT01109108|O1|Outcome|Children 0<2 Years of Age|Children 0<2 years of age with and without respiratory tract infection
643461|NCT01109108|E2|Reported Event|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
643462|NCT01109108|E1|Reported Event|Children <2 Years of Age|Children <2 years of age with and without respiratory tract infection
643463|NCT01109147|B4|Baseline|Total|Total of all reporting groups
643464|NCT01109147|B3|Baseline|Control|healthy volunteers
643465|NCT01109147|B2|Baseline|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
643466|NCT01109147|B1|Baseline|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
643467|NCT01109147|P3|Participant Flow|Control|healthy volunteers
643468|NCT01109147|P2|Participant Flow|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
643469|NCT01109147|P1|Participant Flow|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
643470|NCT01109147|O3|Outcome|Control|healthy volunteers
644658|NCT01114945|B3|Baseline|GlideScope|GlideScope device
643474|NCT01109147|E2|Reported Event|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
643475|NCT01109147|E1|Reported Event|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
643476|NCT01109173|B5|Baseline|Total|Total of all reporting groups
643477|NCT01109173|B4|Baseline|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
643478|NCT01109173|B3|Baseline|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
643479|NCT01109173|B2|Baseline|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
643480|NCT01109173|B1|Baseline|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
643481|NCT01109173|P4|Participant Flow|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
643482|NCT01109173|P3|Participant Flow|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
643483|NCT01109173|P2|Participant Flow|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
643484|NCT01109173|P1|Participant Flow|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
643485|NCT01109173|O4|Outcome|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
643486|NCT01109173|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
643487|NCT01109173|O2|Outcome|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
643488|NCT01109173|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
643489|NCT01109173|O4|Outcome|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
643490|NCT01109173|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
643491|NCT01109173|O2|Outcome|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
643492|NCT01109173|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
643493|NCT01109173|E4|Reported Event|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
643494|NCT01109173|E3|Reported Event|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
644818|NCT01115660|B3|Baseline|Total|Total of all reporting groups
643495|NCT01109173|E2|Reported Event|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
643496|NCT01109173|E1|Reported Event|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
643497|NCT01109316|B7|Baseline|Total|Total of all reporting groups
643498|NCT01109316|B6|Baseline|A6D/L6D/L2D|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks.
643499|NCT01109316|B5|Baseline|A6D/L2D/L6D|Insulin Aspart 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643500|NCT01109316|B4|Baseline|L6D/A6D/L2D|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks.
643501|NCT01109316|B3|Baseline|L6D/L2D/A6D|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643502|NCT01109316|B2|Baseline|L2D/A6D/L6D|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643503|NCT01109316|B1|Baseline|L2D/L6D/A6D|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643504|NCT01109316|P3|Participant Flow|Insulin Aspart 6 Day (A6D)|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
643505|NCT01109316|P2|Participant Flow|Insulin Lispro 6 Day (L6D)|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
643506|NCT01109316|P1|Participant Flow|Insulin Lispro 2 Day (L2D)|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
643507|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643508|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643509|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643510|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643511|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643512|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643513|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643514|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643515|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643516|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643517|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643518|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643519|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643520|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643521|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643522|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643523|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643524|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643525|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643526|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643527|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643528|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643529|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643530|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643531|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643532|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643533|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643534|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643535|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643536|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643537|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643538|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643539|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643540|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643541|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643542|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643543|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643544|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643545|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643546|NCT01109316|E3|Reported Event|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
643547|NCT01109316|E2|Reported Event|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
643548|NCT01109316|E1|Reported Event|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
643549|NCT01109381|B1|Baseline|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid
GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
644637|NCT01114893|P4|Participant Flow|Travoprost Group B|Travoprost Group B
643550|NCT01109381|P1|Participant Flow|GT08|"Initial phase - omeprazole, N-acetylcysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid
GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
643551|NCT01109381|O1|Outcome|Treatment|"Initial phase - omeprazole, NAC (N-acetyl cysteine), lauric acid with dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid
GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
643552|NCT01109381|O1|Outcome|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid
GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
643553|NCT01109381|O1|Outcome|Treatment With GT08|"Initial phase - omeprazole, N-acetyl cysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid
GT08 means treatment with omeprazole 40mg daily, lauric acid 150-300mg daily, and NAC 1.2 - 2g daily"
643554|NCT01109381|E1|Reported Event|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid
GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
643555|NCT01109524|B1|Baseline|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
643556|NCT01109524|P1|Participant Flow|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
643557|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
643558|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
644952|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
643559|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
643572|NCT01109602|B1|Baseline|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance
Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
644638|NCT01114893|P3|Participant Flow|Travoprost Group A|Travoprost Group A
643560|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
643561|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
643562|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
643563|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
643564|NCT01109524|E1|Reported Event|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter squared (m²), week 1, then 250mg/m² weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped the treatment. One hour of observation required after each infusion. IV cisplatin, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles. Pre-cisplatin hydration could begin during 1-hour post cetuximab observation period. IV vinorelbine, 80mg/m², Day 1 of each 21 day cycle, maximum 6 cycles. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
643565|NCT01109576|B1|Baseline|DSL Workshop Participants|"Three to five Veterans with DSL.
DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
643566|NCT01109576|P1|Participant Flow|DSL Workshop Participants|"Three to five Veterans with DSL.
DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers.
Participant Flow Completed: Twelve participants completed the entire protocol, including all outcomes measures."
643567|NCT01109576|O1|Outcome|DSL Workshop Participants|"Three to five Veterans with DSL.
DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
643568|NCT01109576|E1|Reported Event|DSL Workshop Participants|"Dual Sensory Loss (DSL) workshop participants. Three to five Veterans with DSL.
DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
643569|NCT01109602|B4|Baseline|Total|Total of all reporting groups
643570|NCT01109602|B3|Baseline|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
643571|NCT01109602|B2|Baseline|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.
Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
643573|NCT01109602|P3|Participant Flow|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
643574|NCT01109602|P2|Participant Flow|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.
Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
643575|NCT01109602|P1|Participant Flow|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance
Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
643576|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
643577|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
643578|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
643579|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
643580|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
643581|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
643582|NCT01109602|E3|Reported Event|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
643583|NCT01109602|E2|Reported Event|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.
Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
643584|NCT01109602|E1|Reported Event|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance
Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
643585|NCT01109849|B3|Baseline|Total|Total of all reporting groups
643586|NCT01109849|B2|Baseline|ER Stimulant|"daily use of 12 hour extended release methylphenidate product
12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
643587|NCT01109849|B1|Baseline|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject
behavioral therapy: combination of individual and group parent training plus school consultation"
643647|NCT01109979|E2|Reported Event|E+DRSP|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
644953|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
643588|NCT01109849|P5|Participant Flow|Monitoring|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and continuation of daily extended release stimulant.
643589|NCT01109849|P4|Participant Flow|Drug Holiday|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and limiting CNS stimulant medication to school days only.
643590|NCT01109849|P3|Participant Flow|Caloric Supplementation|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks, continuation of a daily extended release stimulant and the addition of a liquid 8oz caloric supplement every evening.
643591|NCT01109849|P2|Participant Flow|ER Stimulant|"daily use of 12 hour extended release (ER) methylphenidate product
12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
643592|NCT01109849|P1|Participant Flow|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject
behavioral therapy: combination of individual and group parent training plus school consultation"
643593|NCT01109849|O3|Outcome|Monitoring|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were randomly assigned to 1 of 3 weight recovery treatments and did not change their frequency of medication use after the weight recovery randomization (either used the majority of non school days pre and post randomization or did not use med the majority of non school days pre and post randomization).
This arm also consisted of monthly weight checks."
643594|NCT01109849|O2|Outcome|Drug Holiday|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were previously using medication on the majority of non school days but then stopped using medication on the majority of non school days.
This arm also consisted of monthly weight checks and use of ER stimulant on school days only."
643595|NCT01109849|O1|Outcome|Caloric Supplementation|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and used caloric supplementation for at least the majority of the days in the weight recovery phase.
This arm also consisted of monthly weight checks, continuation of a daily extended release stimulant."
643596|NCT01109849|O3|Outcome|Monitoring|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were randomly assigned to 1 of 3 weight recovery treatments and did not change their frequency of medication use after the weight recovery randomization (either used the majority of non school days pre and post randomization or did not use med the majority of non school days pre and post randomization).
This arm also consisted of monthly weight checks."
643597|NCT01109849|O2|Outcome|Drug Holiday|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were previously using medication on the majority of non school days but then stopped using medication on the majority of non school days.
This arm also consisted of monthly weight checks and use of ER stimulant on school days only."
643598|NCT01109849|O1|Outcome|Caloric Supplementation|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and used caloric supplementation for at least the majority of the days in the weight recovery phase.
This arm also consisted of monthly weight checks, continuation of a daily extended release stimulant."
643599|NCT01109849|O3|Outcome|Monitoring|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were randomly assigned to 1 of 3 weight recovery treatments and did not change their frequency of medication use after the weight recovery randomization (either used the majority of non school days pre and post randomization or did not use med the majority of non school days pre and post randomization).
This arm also consisted of monthly weight checks."
643600|NCT01109849|O2|Outcome|Drug Holiday|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and were previously using medication on the majority of non school days but then stopped using medication on the majority of non school days.
This arm also consisted of monthly weight checks and use of ER stimulant on school days only."
643601|NCT01109849|O1|Outcome|Caloric Supplementation|"Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery and used caloric supplementation for at least the majority of the days in the weight recovery phase.
This arm also consisted of monthly weight checks, continuation of a daily extended release stimulant."
643602|NCT01109849|O3|Outcome|Rare Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rare med group used med <12.5% of the study duration (with most using not at all).
643603|NCT01109849|O2|Outcome|Inconsistent Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The inconsistent med group used med at least 12.5% of the time in the study but less than 87.5% of the time in the study (mean usage was 45% of time in study).
643604|NCT01109849|O1|Outcome|Consistent Medication|participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44, 29.5% female) used med <12.5% of the study duration (with most using not at all). The consistent med group used med for at least 87.5% of their time in the study with most using the entire time.
643605|NCT01109849|O3|Outcome|Rare Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rare med group used med <12.5% of the study duration (with most using not at all).
643648|NCT01109979|E1|Reported Event|E+MPA|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
643649|NCT01110005|B3|Baseline|Total|Total of all reporting groups
643606|NCT01109849|O2|Outcome|Inconsistent Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The inconsistent med group used med at least 12.5% of the time in the study but less than 87.5% of the time in the study (mean usage was 45% of time in study).
643607|NCT01109849|O1|Outcome|Consistent Medication|participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44, 29.5% female) used med <12.5% of the study duration (with most using not at all). The consistent med group used med for at least 87.5% of their time in the study with most using the entire time.
643608|NCT01109849|O3|Outcome|Rare Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rare med group used med <12.5% of the study duration (with most using not at all).
643658|NCT01110005|O2|Outcome|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
644659|NCT01114945|B2|Baseline|Video-Mac|Video-Mac device
643609|NCT01109849|O2|Outcome|Inconsistent Medication Group|measures change in z height from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The inconsistent med group used med at least 12.5% of the time in the study but less than 87.5% of the time in the study (mean usage was 45% of time in study).
643610|NCT01109849|O1|Outcome|Consistent Medication|participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44, 29.5% female) used med <12.5% of the study duration (with most using not at all). The consistent med group used med for at least 87.5% of their time in the study with most using the entire time.
643611|NCT01109849|O3|Outcome|Monitoring|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and continuation of daily extended release stimulant.
643612|NCT01109849|O2|Outcome|Drug Holiday|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and limiting CNS stimulant medication to school days only.
643613|NCT01109849|O1|Outcome|Caloric Supplementation|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks, continuation of a daily extended release stimulant and the addition of a liquid 8oz caloric supplement every evening.
643614|NCT01109849|O3|Outcome|Monitoring|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and continuation of daily extended release stimulant.
643615|NCT01109849|O2|Outcome|Drug Holiday|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and limiting CNS stimulant medication to school days only.
643616|NCT01109849|O1|Outcome|Caloric Supplementation|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks, continuation of a daily extended release stimulant and the addition of a liquid 8oz caloric supplement every evening.
643617|NCT01109849|O3|Outcome|Monitoring|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and continuation of daily extended release stimulant.
643618|NCT01109849|O2|Outcome|Drug Holiday|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and limiting CNS stimulant medication to school days only.
643619|NCT01109849|O1|Outcome|Caloric Supplementation|Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks, continuation of a daily extended release stimulant and the addition of a liquid 8oz caloric supplement every evening.
643620|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product
12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm Med group allowed to participate in initial basic parent training course Additional Behavioral therapy services allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
643621|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject
behavioral therapy: combination of individual and group parent training plus school consultation medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
643622|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product
12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
643623|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject
behavioral therapy: combination of individual and group parent training plus school consultation medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
643624|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product
12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
643650|NCT01110005|B2|Baseline|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
644337|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
643625|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject
behavioral therapy: combination of individual and group parent training plus school consultation medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
643626|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product
12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
643627|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject
behavioral therapy: combination of individual and group parent training plus school consultation medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
643628|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product
12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
644639|NCT01114893|P2|Participant Flow|Travoprost Vehicle|Travoprost Vehicle
643629|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject
behavioral therapy: combination of individual and group parent training plus school consultation"
643630|NCT01109849|O1|Outcome|Weight Promotion Treatment- Caloric Supplement|"Subjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals- either increased monitoring of growth, caloric supplement or drug holiday where only use ADHD medication for school
12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm
increased monitoring of growth: monthly weight, height and BMI checks
drug holiday: switch from seven day a week dosing to medication only on school days
caloric supplement: continue current ADHD regimen and add one 8oz liquid caloric supplement at night"
643631|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product
12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
643632|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject
behavioral therapy: combination of individual and group parent training plus school consultation
medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
643633|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product
12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
643634|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject
behavioral therapy: combination of individual and group parent training plus school consultation medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
643635|NCT01109849|O2|Outcome|ER Stimulant|"daily use of 12 hour extended release methylphenidate product
12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm"
643636|NCT01109849|O1|Outcome|Behavior Therapy|"10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject
behavioral therapy: combination of individual and group parent training plus school consultation
medication usage allowed after month 6 if still moderately impaired or worse on Clinical Global Impressions"
643637|NCT01109849|E3|Reported Event|Dose Optimzed|This arm includes the 142 participants that had their dose of study medication systematically optimized through assessment of efficacy and tolerability at home and school. There participants could have come from either of the other two arms- initially assigned to either med or behavior. We added this post hoc arm as a subset of participants randomized to med never used med and a subset of behavior randomized participants did use medication. This group reports adverse event rates only in participants who used med for a sufficient duration to have their dose optimized.
643638|NCT01109849|E2|Reported Event|ER Stimulant|"Participants completing a baseline assessment and at least one post baseline assessment of adverse events who were initially assigned to daily use of extended release CNS Stimulant
All study medication was prescribed to be taken daily for duration of study unless assigned to weight promotion drug holiday arm
includes all participants with at least one post baseline assessment of adverse events"
643639|NCT01109849|E1|Reported Event|Behavior Therapy|"Participants completing a baseline assessment and at least one post baseline assessment of adverse events and were initially assigned to behavior arm which included a basic parenting intervention, additional advanced 8 week parent training intervention, monthly boosters, option for individual parent training sessions, and a school consultant assigned to each subject.
Medication usage allowed after month 6 if at least moderately impaired
includes all participants with at least one post baseline assessment of adverse events"
643640|NCT01109979|B3|Baseline|Total|Total of all reporting groups
643641|NCT01109979|B2|Baseline|E+DRSP, Then E+MPA|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
643642|NCT01109979|B1|Baseline|E+MPA, Then E+DRSP|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
643643|NCT01109979|P2|Participant Flow|E+DRSP, Then E+MPA|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
643644|NCT01109979|P1|Participant Flow|E+MPA, Then E+DRSP|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
643645|NCT01109979|O2|Outcome|E+DRSP|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
643646|NCT01109979|O1|Outcome|E+MPA|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
643651|NCT01110005|B1|Baseline|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
643652|NCT01110005|P2|Participant Flow|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
643653|NCT01110005|P1|Participant Flow|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
643654|NCT01110005|O2|Outcome|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
643655|NCT01110005|O1|Outcome|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
643656|NCT01110005|O2|Outcome|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
643657|NCT01110005|O1|Outcome|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
644640|NCT01114893|P1|Participant Flow|TRAVATAN|TRAVATAN 0.004% once daily
643659|NCT01110005|O1|Outcome|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
643660|NCT01110005|E2|Reported Event|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
643661|NCT01110005|E1|Reported Event|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
643662|NCT01104376|B1|Baseline|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:
In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
643663|NCT01104376|P1|Participant Flow|CYP2B6 Activity|"CYP2B6 activity was measured using efavirenz metabolism and pharmacokinetics at baseline and after pretreatment with voriconazole.
In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered.
In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
643664|NCT01104376|O1|Outcome|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:
In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
643665|NCT01104376|E1|Reported Event|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:
In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
643666|NCT01104493|B3|Baseline|Total|Total of all reporting groups
643667|NCT01104493|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
643668|NCT01104493|B1|Baseline|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
643669|NCT01104493|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
643670|NCT01104493|P1|Participant Flow|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
643671|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
643672|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
643673|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
643674|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
643675|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
644029|NCT01112670|P6|Participant Flow|ABCB1 Group 3*|ABCB1 TTT/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 5 participants started. 5 participants completed.
643676|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
643677|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
643678|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
643679|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
643680|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
643681|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
643682|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
643683|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
643684|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
643685|NCT01104493|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
643686|NCT01104493|E1|Reported Event|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
643687|NCT01104558|B1|Baseline|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643688|NCT01104558|P1|Participant Flow|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643689|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643690|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643691|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643692|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643693|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643694|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643826|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
644954|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
643695|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643696|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643697|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
644034|NCT01112670|P1|Participant Flow|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 8 participants started. 7 participants completed.
643698|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643699|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643700|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643701|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643702|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643703|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643704|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643705|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643706|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643707|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643708|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643709|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643710|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643711|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643712|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643828|NCT01110200|E2|Reported Event|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643713|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643714|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643715|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643716|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643717|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643718|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643719|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643720|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643721|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643722|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643723|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643724|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643725|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643726|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643727|NCT01104558|E1|Reported Event|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
643728|NCT01104584|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
643729|NCT01104584|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
643827|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643970|NCT01112059|O1|Outcome|Placebo|placebo for 8 days
643730|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
643731|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
643732|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
643733|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
643734|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
643735|NCT01104584|O1|Outcome|CMRM Versus UMRM|
643736|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
643737|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
643738|NCT01104584|O1|Outcome|CMRM Versus UMRM|
643739|NCT01104584|O1|Outcome|CMRM|
643740|NCT01104584|O1|Outcome|CMRM|
643741|NCT01104584|O1|Outcome|CMRM|
643742|NCT01104584|O1|Outcome|CMRM Versus UMRM|
643743|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
643744|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
643745|NCT01104584|O1|Outcome|CMRM vs UMRM|
643746|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
643747|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
643748|NCT01104584|O1|Outcome|CMRM vs UMRM|
643749|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
643750|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
643751|NCT01104584|O1|Outcome|CMRM vs UMRM|
643752|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
643753|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
643754|NCT01104584|O1|Outcome|CMRM vs UMRM|
643755|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
643756|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
643757|NCT01104584|O1|Outcome|CMRM vs UMRM|
643758|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
643759|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
643760|NCT01104584|O1|Outcome|CMRM vs UMRM|
643761|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
643762|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
643763|NCT01104584|O1|Outcome|CMRM vs UMRM|
643764|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
643765|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
643766|NCT01104584|O1|Outcome|CMRM vs UMRM|
643767|NCT01104584|O5|Outcome|CMRM+XRM|
643768|NCT01104584|O4|Outcome|UMRM+XRM|
643769|NCT01104584|O3|Outcome|X-ray Mammography (XRM)|
643770|NCT01104584|O2|Outcome|CMRM|
643771|NCT01104584|O1|Outcome|UMRM|
643772|NCT01104584|O4|Outcome|UMRM+XRM|
643773|NCT01104584|O3|Outcome|CMRM+XRM|
643774|NCT01104584|O2|Outcome|X-ray Mammography (XRM)|
643775|NCT01104584|O1|Outcome|UMRM|
643776|NCT01104584|O4|Outcome|UMRM+XRM|
643777|NCT01104584|O3|Outcome|CMRM+XRM|
643778|NCT01104584|O2|Outcome|X-ray Mammography (XRM)|
643779|NCT01104584|O1|Outcome|UMRM|
643780|NCT01104584|O3|Outcome|UMRM+XRM|
643781|NCT01104584|O2|Outcome|CMRM+XRM|
643782|NCT01104584|O1|Outcome|X-ray Mammography (XRM)|
643783|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
643784|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
643785|NCT01104584|O1|Outcome|CMRM Versus UMRM|
643786|NCT01104584|O3|Outcome|CMRM vs CMRM+XRM|
643787|NCT01104584|O2|Outcome|CMRM vs XRM|
643788|NCT01104584|O1|Outcome|CMRM Versus UMRM|
643789|NCT01104584|O3|Outcome|CMRM vs CMRM+XRM|
643790|NCT01104584|O2|Outcome|CMRM vs XRM|
643791|NCT01104584|O1|Outcome|CMRM Versus UMRM|
643792|NCT01104584|O1|Outcome|CMRM|
643793|NCT01104584|O1|Outcome|CMRM|
643794|NCT01104584|O2|Outcome|UMRM|
643795|NCT01104584|O1|Outcome|CMRM|
643796|NCT01104584|O1|Outcome|CMRM Versus UMRM|
643797|NCT01104584|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
643798|NCT01110135|B1|Baseline|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
bendamustine hydrochloride: Given IV
dexamethasone: Given PO
filgrastim: Given SC
leukapheresis: Given IV
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies
etoposide: Given IV"
643799|NCT01110135|P1|Participant Flow|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
bendamustine hydrochloride: Given IV
dexamethasone: Given PO
filgrastim: Given SC
leukapheresis: Given IV
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies
etoposide: Given IV"
643834|NCT01110239|B1|Baseline|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
643835|NCT01110239|P4|Participant Flow|10-min Ischemia|
643836|NCT01110239|P3|Participant Flow|7.5-min Ischemia|
643837|NCT01110239|P2|Participant Flow|5-min Ischemia|
643800|NCT01110135|O1|Outcome|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
bendamustine hydrochloride: Given IV
dexamethasone: Given PO
filgrastim: Given SC
leukapheresis: Given IV
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies
etoposide: Given IV"
643801|NCT01110135|E1|Reported Event|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
bendamustine hydrochloride: Given IV
dexamethasone: Given PO
filgrastim: Given SC
leukapheresis: Given IV
laboratory biomarker analysis: Correlative studies
flow cytometry: Correlative studies
etoposide: Given IV"
643802|NCT01110187|B3|Baseline|Total|Total of all reporting groups
643803|NCT01110187|B2|Baseline|IV fPHT|patients randomized to IV fPHT (4)
643804|NCT01110187|B1|Baseline|IV LCM|patients randomized to IV LCM (7)
643805|NCT01110187|P2|Participant Flow|IV fPHT|"Patients randomized to fPHT (fos-phenytoin) with moderate or severe TBI. For IV fPHT dosing and adjustment see Intervention section."
643806|NCT01110187|P1|Participant Flow|IV LCM|"Patients with severe TBI later randomized to seizure prophylaxis with LCM (Lacosamide). For IV LCM dosing and adjustment see Intervention section."
643807|NCT01110187|O2|Outcome|IV fPHT|"Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin
Fosphenytoin: 20 mgPE/kg IV over 60 minutes and then will be started on a maintenance dose (5 mgPE/kg/day, rounded to nearest dose of 150 mgPE IV, BID administered as per pharmacy protocol consistent with acceptable standards of care for 7 days"
643808|NCT01110187|O1|Outcome|IV LCM|"Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide.
lacosamide: 200 mg IV over 60 minutes; these patients will then be started on a maintenance dose 100 mg, IV BID as prophylaxis administered as per pharmacy protocol consistent with acceptable standards of care for 7 days. The Lacosamide dose can be adjusted as needed if seizures occur for therapeutic effect up to 200 mg bid (400 mg/d) as a maximum dose."
643809|NCT01110187|O2|Outcome|IV fPHT|Patients with severe TBI randomized to seizure prophylaxis with fPHT
643810|NCT01110187|O1|Outcome|IV LCM|Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
643811|NCT01110187|E2|Reported Event|IV fPHT|Patients with severe TBI later randomized to seizure prophylaxis with phenytoin.
643812|NCT01110187|E1|Reported Event|IV LCM|Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
643813|NCT01110200|B3|Baseline|Total|Total of all reporting groups
643814|NCT01110200|B2|Baseline|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643815|NCT01110200|B1|Baseline|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643816|NCT01110200|P2|Participant Flow|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643817|NCT01110200|P1|Participant Flow|FSC 250/50|Participants (par.) self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643818|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643819|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643820|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643821|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643822|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643823|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643824|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643825|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643829|NCT01110200|E1|Reported Event|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
643830|NCT01110239|B5|Baseline|Total|Total of all reporting groups
643831|NCT01110239|B4|Baseline|10 Min Ischemia|
643832|NCT01110239|B3|Baseline|7.5 Min Ischemia|
643833|NCT01110239|B2|Baseline|5 Min Ischemia|
643838|NCT01110239|P1|Participant Flow|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes. A sham preconditioning group was added with only minimal cuff inflation.
643839|NCT01110239|O4|Outcome|10 Min Ischemia|
643840|NCT01110239|O3|Outcome|7.5 Min Ischemia|
643841|NCT01110239|O2|Outcome|5 Min Ischemia|
643842|NCT01110239|O1|Outcome|Sham Preconditioning|Limb preconditioning intervention at increasing durations of ischemia: 5, 7.5 and 10 min.
643843|NCT01110239|O4|Outcome|10 Min Ischemia|
643844|NCT01110239|O3|Outcome|7.5 Min Ischemia|
643845|NCT01110239|O2|Outcome|5 Min Ischemia|
643846|NCT01110239|O1|Outcome|Sham Preconditioning|leg preconditioning with increasing durations of ischemia divided into 4 groups: sham preconditioning 3 cycles of 5min blood pressure cuff application 3 times 5 min cycles 3 times 7.5 min cycles 3 times 10 min cycles
643847|NCT01110239|E4|Reported Event|10 Min Ischemia|
643848|NCT01110239|E3|Reported Event|7.5 Min Ischemia|
643849|NCT01110239|E2|Reported Event|5 Min Ischemia|
643850|NCT01110239|E1|Reported Event|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
643851|NCT01110252|B1|Baseline|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
643852|NCT01110252|P1|Participant Flow|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
643853|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
643854|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
643855|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
643856|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
643857|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
643858|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
643859|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
643860|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
643861|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
643862|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
643863|NCT01110252|E1|Reported Event|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
643864|NCT01110330|B4|Baseline|Total|Total of all reporting groups
643865|NCT01110330|B3|Baseline|Ketoconazole|Ketoconazole 2% cream (formulation F126)
643866|NCT01110330|B2|Baseline|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
643867|NCT01110330|B1|Baseline|Placebo|A topical white homogenous cream identical in appearance to study drug
643868|NCT01110330|P3|Participant Flow|Ketoconazole|Ketoconazole 2% cream (formulation F126)
643869|NCT01110330|P2|Participant Flow|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
643870|NCT01110330|P1|Participant Flow|Placebo|A topical white homogenous cream identical in appearance to study drug
643871|NCT01110330|O3|Outcome|Ketoconazole|Ketoconazole 2% cream (formulation F126)
643872|NCT01110330|O2|Outcome|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
643873|NCT01110330|O1|Outcome|Placebo|A topical white homogenous cream identical in appearance to study drug
643874|NCT01110330|O3|Outcome|Ketoconazole|Ketoconazole 2% cream (formulation F126)
643875|NCT01110330|O2|Outcome|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
643876|NCT01110330|O1|Outcome|Placebo|A topical white homogenous cream identical in appearance to study drug
643877|NCT01110330|E3|Reported Event|Placebo|A topical white homogenous cream identical in appearance to study drug
643878|NCT01110330|E2|Reported Event|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
643879|NCT01110330|E1|Reported Event|Ketoconazole|Ketoconazole 2% cream (formulation F126)
643880|NCT01110382|B3|Baseline|Total|Total of all reporting groups
643881|NCT01110382|B2|Baseline|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643971|NCT01112059|O2|Outcome|Placebo|placebo for 8 days
643972|NCT01112059|O1|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
643882|NCT01110382|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643883|NCT01110382|P2|Participant Flow|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643884|NCT01110382|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
644031|NCT01112670|P4|Participant Flow|ABCB1 Group 2*|ABCB1 CGC/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagiptin. 4 participants started. 4 participants completed.
643885|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643886|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643887|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643888|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643889|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643890|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643891|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643892|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643893|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643894|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643895|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643896|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643897|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643898|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643899|NCT01110382|E2|Reported Event|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643900|NCT01110382|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
643901|NCT01110408|B3|Baseline|Total|Total of all reporting groups
643902|NCT01110408|B2|Baseline|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643903|NCT01110408|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643904|NCT01110408|P2|Participant Flow|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643905|NCT01110408|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643906|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643907|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643908|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643909|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
644032|NCT01112670|P3|Participant Flow|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 7 participants started. 6 participants completed.
644035|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
643910|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643911|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643912|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643913|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643914|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643915|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643916|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643917|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643918|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643919|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643920|NCT01110408|E2|Reported Event|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643921|NCT01110408|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643922|NCT01110421|B3|Baseline|Total|Total of all reporting groups
643923|NCT01110421|B2|Baseline|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643924|NCT01110421|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643925|NCT01110421|P2|Participant Flow|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643926|NCT01110421|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643927|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643928|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643929|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643930|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643931|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643932|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643933|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643934|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643935|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643936|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643937|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643938|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643939|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643940|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643941|NCT01110421|E2|Reported Event|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643942|NCT01110421|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
643943|NCT01111838|B1|Baseline|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
643944|NCT01111838|P1|Participant Flow|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
643945|NCT01111838|O1|Outcome|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
643946|NCT01111838|E1|Reported Event|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
643947|NCT01111851|B3|Baseline|Total|Total of all reporting groups
643948|NCT01111851|B2|Baseline|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
643949|NCT01111851|B1|Baseline|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
643950|NCT01111851|P2|Participant Flow|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
643951|NCT01111851|P1|Participant Flow|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
643952|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
643953|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
643954|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
643955|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
643956|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
643957|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
643958|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
643959|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
643960|NCT01111851|E2|Reported Event|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
643961|NCT01111851|E1|Reported Event|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
643962|NCT01112059|B3|Baseline|Total|Total of all reporting groups
643963|NCT01112059|B2|Baseline|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
643964|NCT01112059|B1|Baseline|Placebo|placebo: placebo
643965|NCT01112059|P2|Participant Flow|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
643966|NCT01112059|P1|Participant Flow|Placebo|placebo: placebo
643967|NCT01112059|O2|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
643968|NCT01112059|O1|Outcome|Placebo|placebo for 8 days
643969|NCT01112059|O2|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
643977|NCT01112241|B1|Baseline|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
644036|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
643978|NCT01112241|P1|Participant Flow|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643979|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643980|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643981|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643982|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643983|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643984|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643985|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643986|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643987|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643988|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643989|NCT01112241|E1|Reported Event|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
643990|NCT01112267|B3|Baseline|Total|Total of all reporting groups
643991|NCT01112267|B2|Baseline|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
643992|NCT01112267|B1|Baseline|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
643993|NCT01112267|P2|Participant Flow|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
643994|NCT01112267|P1|Participant Flow|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
643995|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644033|NCT01112670|P2|Participant Flow|ABCB1 Group 1*|ABCB1 CGC/CGC genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 3 participants started. 3 participants completed.
643996|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
643997|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
643998|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
643999|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644000|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644001|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644002|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644003|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644004|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644005|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644006|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644007|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644008|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644009|NCT01112267|E2|Reported Event|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644010|NCT01112267|E1|Reported Event|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
644011|NCT01112514|B1|Baseline|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
644012|NCT01112514|P1|Participant Flow|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
644013|NCT01112514|O1|Outcome|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
644014|NCT01112514|E1|Reported Event|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
644015|NCT01112579|B3|Baseline|Total|Total of all reporting groups
644016|NCT01112579|B2|Baseline|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
644017|NCT01112579|B1|Baseline|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
644018|NCT01112579|P2|Participant Flow|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
644019|NCT01112579|P1|Participant Flow|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
644020|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
644021|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
644022|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
644023|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
644024|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
644025|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
644026|NCT01112579|E2|Reported Event|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
644027|NCT01112579|E1|Reported Event|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
644028|NCT01112670|B1|Baseline|Overall Study Population|All participants who participated in at least one period of the study (n=33)
644955|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644030|NCT01112670|P5|Participant Flow|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 6 participants started. 5 participants completed.
644037|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
644068|NCT01112670|E1|Reported Event|Overall Study Population|All participants who started the study (n=33)
644069|NCT01112683|B3|Baseline|Total|Total of all reporting groups
644070|NCT01112683|B2|Baseline|Placebo|These are identically-looking pills to the ones in the Memantine Arm
644071|NCT01112683|B1|Baseline|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
644072|NCT01112683|P2|Participant Flow|Placebo|These are identically-looking pills to the ones in the Memantine Arm
644073|NCT01112683|P1|Participant Flow|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
644074|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
644075|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
644076|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
644077|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
644078|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
644079|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
644080|NCT01112683|E2|Reported Event|Placebo|These are identically-looking pills to the ones in the Memantine Arm
644081|NCT01112683|E1|Reported Event|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
644082|NCT01112696|B1|Baseline|Group 1|Sensor Users (All Subjects)
644083|NCT01112696|P1|Participant Flow|Group 1|Sensor Users (All Subjects)
644084|NCT01112696|O1|Outcome|All Completed Subjects|All subjects that completed the frequent blood sampling procedure
644085|NCT01112696|E1|Reported Event|Group 1|Sensor Users (All Subjects)
644086|NCT01112865|B1|Baseline|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
644087|NCT01112865|P2|Participant Flow|Genotropin® Pen Then Mark VII Pen|Participant (not caregiver) used current Genotropin® pen (subcutaneous injections daily for 2 months) then the Mark VII pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
644088|NCT01112865|P1|Participant Flow|Mark VII Pen Then Genotropin® Pen|Participant (not caregiver) used Mark VII pen (subcutaneous injections daily for 2 months) then the current Genotropin® pen (subcutaneous injections daily for 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin recombinant deoxyribonucleic acid [rDNA] origin); doses received by participants based on body weight.
644089|NCT01112865|O2|Outcome|Genotropin® Pen|Participants who used the current Genotropin® pen (subcutaneous injections daily for 2 months) anytime during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
644090|NCT01112865|O1|Outcome|Mark VII Pen|Participants who used the Mark VII pen (subcutaneous injections daily for 2 months) any time during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin recombinant deoxyribonucleic acid [rDNA] origin); doses received by participants based on body weight.
644091|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
644092|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
644093|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
644094|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
644095|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
644096|NCT01112865|E1|Reported Event|Safety Population|All randomized participants who used a study pen (Genotropin® pen or the new Mark VII injection pen) at least once to administer Genotropin.
644097|NCT01112917|B1|Baseline|VenaTech Convertible Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
644098|NCT01112917|P2|Participant Flow|VenaTech Convertible Filter - Permanent Filtration|VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
644099|NCT01112917|P1|Participant Flow|VenaTech Convertible Filter - Converted Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
644100|NCT01112917|O1|Outcome|VenaTech Convertible Filter - Converted Filters|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
644101|NCT01112917|O1|Outcome|VenaTech Convertible Filter - Converted Filters|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
644102|NCT01112917|E1|Reported Event|VenaTech Convertible Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
644103|NCT01113008|B3|Baseline|Total|Total of all reporting groups
644104|NCT01113008|B2|Baseline|Control Group|Control group: In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
644105|NCT01113008|B1|Baseline|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)
Remote ischemic postconditioning: Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
644106|NCT01113008|P2|Participant Flow|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)
Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
644107|NCT01113008|P1|Participant Flow|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
644108|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)
Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
644109|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
644110|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)
Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
644111|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
644162|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644112|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)
Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
644113|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
644114|NCT01113008|E2|Reported Event|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)
Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
644115|NCT01113008|E1|Reported Event|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
644116|NCT01113385|B1|Baseline|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.
D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
644117|NCT01113385|P1|Participant Flow|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.
D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
644118|NCT01113385|O1|Outcome|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.
D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
644119|NCT01113385|O1|Outcome|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.
D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
644120|NCT01113385|E1|Reported Event|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.
D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
644121|NCT01113398|B1|Baseline|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
644122|NCT01113398|P1|Participant Flow|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
644123|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
644124|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
644125|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
644126|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
644163|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644164|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644127|NCT01113398|E1|Reported Event|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
644128|NCT01113463|B1|Baseline|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
644129|NCT01113463|P1|Participant Flow|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
644130|NCT01113463|O1|Outcome|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
644131|NCT01113463|O1|Outcome|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
644132|NCT01113463|E1|Reported Event|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
644133|NCT01113541|B1|Baseline|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644134|NCT01113541|P1|Participant Flow|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644135|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644136|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644137|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644138|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644139|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644140|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644141|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644142|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644143|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644144|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644641|NCT01114893|O5|Outcome|Travoprost Group C|
644642|NCT01114893|O4|Outcome|Travoprost Group B|
644145|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644146|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644147|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644148|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644149|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644150|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644151|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644152|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644153|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644154|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644155|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644156|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644157|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644158|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644159|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644160|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644161|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644956|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644165|NCT01113541|E1|Reported Event|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
644166|NCT01113580|B3|Baseline|Total|Total of all reporting groups
644167|NCT01113580|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older
644168|NCT01113580|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years
644169|NCT01113580|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older
644170|NCT01113580|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years
644171|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
644172|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
644173|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
644174|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
644175|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
644176|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
644177|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
644178|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
644179|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
644180|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
644181|NCT01113580|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older
644182|NCT01113580|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years
644183|NCT01113632|B3|Baseline|Total|Total of all reporting groups
644184|NCT01113632|B2|Baseline|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
644185|NCT01113632|B1|Baseline|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
644186|NCT01113632|P2|Participant Flow|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
644643|NCT01114893|O3|Outcome|Travoprost Group A|
644187|NCT01113632|P1|Participant Flow|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
644188|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
644189|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
644190|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
644191|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
644220|NCT01113723|E2|Reported Event|Flexible Fiberoptic Scope (FFS)|the flexible fiberoptic scope (FFS) the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
644221|NCT01113723|E1|Reported Event|CMAC Device|"CMAC
CMAC: CMAC Device"
644222|NCT01113749|B3|Baseline|Total|Total of all reporting groups
644223|NCT01113749|B2|Baseline|Control|
644610|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644192|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
644193|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
644194|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
644195|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
644196|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
644197|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
644248|NCT01113931|E2|Reported Event|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
644198|NCT01113632|E2|Reported Event|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
644199|NCT01113632|E1|Reported Event|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks
Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
644200|NCT01113710|B1|Baseline|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
644201|NCT01113710|P1|Participant Flow|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
644202|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
644203|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
644204|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
644205|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
644206|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
644207|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
644208|NCT01113710|E1|Reported Event|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
644209|NCT01113723|B3|Baseline|Total|Total of all reporting groups
644210|NCT01113723|B2|Baseline|Fiberoptic Bronchoscope|"Fiberoptic bronchoscope
Fiberoptic bronchoscope: Fiberoptic bronchoscope device"
644211|NCT01113723|B1|Baseline|CMAC Device|"CMAC
CMAC: CMAC Device"
644212|NCT01113723|P2|Participant Flow|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
644213|NCT01113723|P1|Participant Flow|CMAC Device|"CMAC
CMAC: CMAC Device"
644214|NCT01113723|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
644215|NCT01113723|O1|Outcome|CMAC Device|CMAC: CMAC Device
644216|NCT01113723|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
644217|NCT01113723|O1|Outcome|CMAC Device|"CMAC
CMAC: CMAC Device"
644218|NCT01113723|O2|Outcome|Flexible Fiberoptic Scope (FFS)|the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
644219|NCT01113723|O1|Outcome|CMAC Device|CMAC: CMAC Device
644957|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644224|NCT01113749|B1|Baseline|Decision Support|Structured decision aid with prompting to share information in discussion with primary treating health care providers.
644225|NCT01113749|P2|Participant Flow|Control|
644226|NCT01113749|P1|Participant Flow|Decision Support|Structured decision aid with prompting to share information in discussion with primary treating health care providers.
644227|NCT01113749|O2|Outcome|Control|Usual care
644228|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
644229|NCT01113749|O2|Outcome|Control|Usual care
644230|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
644231|NCT01113749|O2|Outcome|Control|Usual care
644232|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
644233|NCT01113749|E2|Reported Event|Control|
644234|NCT01113749|E1|Reported Event|Decisions Support Intervention|
644235|NCT01113931|B3|Baseline|Total|Total of all reporting groups
644236|NCT01113931|B2|Baseline|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
644237|NCT01113931|B1|Baseline|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
644238|NCT01113931|P2|Participant Flow|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
644239|NCT01113931|P1|Participant Flow|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
644240|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
644241|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
644242|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
644243|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
644244|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
644245|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
644246|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
644247|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
644313|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644249|NCT01113931|E1|Reported Event|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
644250|NCT01107457|B6|Baseline|Total|Total of all reporting groups
644251|NCT01107457|B5|Baseline|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Part B: (optional)
Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
Part C: (optional)
Administered 80 mg ixekizumab SC Q4W through week 344."
644252|NCT01107457|B4|Baseline|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
Part C: (optional)
80 mg ixekizumab given SC Q4W through week 344."
644253|NCT01107457|B3|Baseline|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
Part C: (optional)
80 mg ixekizumab given SC Q4W through week 344."
644254|NCT01107457|B2|Baseline|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
Part C: (optional)
80 mg ixekizumab given SC Q4W through week 344."
644255|NCT01107457|B1|Baseline|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
Part C: (optional)
80 mg ixekizumab given SC Q4W through week 344."
644256|NCT01107457|P6|Participant Flow|120 mg/80 mg Total Ixekizumab|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
Part C: (optional)
80 mg ixekizumab given SC Q4W through week 344."
644257|NCT01107457|P5|Participant Flow|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Part B: (optional)
Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
Part C: (optional)
Administered 80 mg ixekizumab SC Q4W through week 344."
644258|NCT01107457|P4|Participant Flow|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
Part C: (optional)
80 mg ixekizumab given SC Q4W through week 344."
644259|NCT01107457|P3|Participant Flow|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
Part C: (optional)
80 mg ixekizumab given SC Q4W through week 344."
644291|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644292|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644260|NCT01107457|P2|Participant Flow|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
Part C: (optional)
80 mg ixekizumab given SC Q4W through week 344."
644261|NCT01107457|P1|Participant Flow|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
Part B: (optional)
120 milligrams (mg) ixekizumab given subcutaneous (SC) every 4 weeks (Q4W). Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.
Part C: (optional)
80 mg ixekizumab given SC Q4W through week 344."
644262|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
644263|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
644264|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
644265|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
644266|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
644267|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
644268|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
644269|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
644270|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC"
644271|NCT01107457|O1|Outcome|Total Ixekizumab (80 mg and 120 mg)|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.
During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC."
644272|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644273|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644274|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644275|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644276|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644277|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644278|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644279|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644280|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644281|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644282|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644283|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644284|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644285|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644286|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644287|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644288|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644289|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644290|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644958|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644293|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644294|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644295|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644296|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644297|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644298|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644299|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644300|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644301|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644302|NCT01107457|O1|Outcome|All Participants (10mg, 25mg,75mg & 150 mg Ixekizumab)|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644303|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644304|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644305|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644306|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644307|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644308|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644309|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644310|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644311|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644312|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644644|NCT01114893|O2|Outcome|Travoprost Vehicle|
644314|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644315|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644316|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644317|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644318|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644319|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644320|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644321|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644322|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644323|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644324|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644325|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644326|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644327|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644328|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644329|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644330|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644331|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644332|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644333|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644334|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644335|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644336|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644959|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644338|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644339|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644340|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644341|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644342|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644343|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644344|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644345|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644346|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644347|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644348|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644349|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644350|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644351|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644352|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644353|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644354|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644355|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644356|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644357|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644358|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644359|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644580|NCT01114880|P2|Participant Flow|Placebo|Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
644360|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644361|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644362|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644363|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644364|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644365|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644366|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644367|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644368|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644369|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644370|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644371|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644372|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644373|NCT01107457|O5|Outcome|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644374|NCT01107457|O4|Outcome|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644375|NCT01107457|O3|Outcome|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644376|NCT01107457|O2|Outcome|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644377|NCT01107457|O1|Outcome|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644378|NCT01107457|E8|Reported Event|Post Treatment Safety Visits|Participants who were followed due to neutropenia.
644379|NCT01107457|E7|Reported Event|120 mg and 80 mg Total Ixekizumab|"Part B: (optional)
120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236."
644380|NCT01107457|E6|Reported Event|Treatment Durability|Part A: Treatment durability/safety follow-up period:12 to 20 weeks.
644381|NCT01107457|E5|Reported Event|150 mg Ixekizumab|"Part A:
150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644382|NCT01107457|E4|Reported Event|75 mg Ixekizumab|"Part A:
75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644383|NCT01107457|E3|Reported Event|25 mg Ixekizumab|"Part A:
25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644384|NCT01107457|E2|Reported Event|10 mg Ixekizumab|"Part A:
10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644385|NCT01107457|E1|Reported Event|Placebo|"Part A:
Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations."
644386|NCT01107535|B1|Baseline|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
644387|NCT01107535|P1|Participant Flow|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
644388|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
644389|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
644390|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
644391|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
644392|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
644393|NCT01107535|E1|Reported Event|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
644394|NCT01114334|B3|Baseline|Total|Total of all reporting groups
644395|NCT01114334|B2|Baseline|Standard Management of Depression|All providers randomized to either intervention or to control received a 1-hour slideshow and the “American Psychiatric Association Practice Guideline for the Treatment of Major Depressive Disorder” (APA depression guideline) (Gelenberg et al., 2010). The resources recommended antidepressant medications and psychotherapy as evidence-based treatments for depression.
644396|NCT01114334|B1|Baseline|Motivational Interviewing With Guideline-Based Management|"Intervention – MI with Standard Management of Depression The MI training approach included interactive learning for the core MI skills. An 8-hour classroom training on 7/25/09 consisted of a brief overview of MI, videos and discussion of core MI skills and “MI Spirit,” as well as skill-building practice. At the providers’ request, the research team distributed a pocket-sized, laminated treatment outline to MI trained providers for use at the point of service
To optimize treatment integrity, 4-hour refresher sessions were offered after 4 and 12 months on 11/22/09 and 7/11/10. Over the first 14 months, the assistant trainer provided feedback via email and face-to face regarding audio-taped encounters (total two to four feedbacks per provider). In these sessions, the trainer also summarized MI skills demonstrated during the encounters and listed each patient’s change talk statements. Providers were invited to respond and to choose which MI skill(s) they needed to improve."
644397|NCT01114334|P2|Participant Flow|Standard Management of Depression|All providers randomized to either intervention or to control received a 1-hour slideshow and the “American Psychiatric Association Practice Guideline for the Treatment of Major Depressive Disorder” (APA depression guideline) (Gelenberg et al., 2010). The resources recommended antidepressant medications and psychotherapy as evidence-based treatments for depression.
644407|NCT01114360|B1|Baseline|All Participants|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.
644408|NCT01114360|P2|Participant Flow|Melatonin/Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8 mg of time released melatonin at bed time for 4 weeks, followed by 8 mg of placebo at bedtime for an additional 4 weeks.
644611|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644398|NCT01114334|P1|Participant Flow|Motivational Interviewing With Guideline-Based Management|"Intervention – MI with Standard Management of Depression The MI training approach included interactive learning for the core MI skills. An 8-hour classroom training on 7/25/09 consisted of a brief overview of MI, videos and discussion of core MI skills and “MI Spirit,” as well as skill-building practice. At the providers’ request, the research team distributed a pocket-sized, laminated treatment outline to MI trained providers for use at the point of service
To optimize treatment integrity, 4-hour refresher sessions were offered after 4 and 12 months on 11/22/09 and 7/11/10. Over the first 14 months, the assistant trainer provided feedback via email and face-to face regarding audio-taped encounters (total two to four feedbacks per provider). In these sessions, the trainer also summarized MI skills demonstrated during the encounters and listed each patient’s change talk statements. Providers were invited to respond and to choose which MI skill(s) they needed to improve."
644399|NCT01114334|O2|Outcome|Motivational Interview With GBMM|"Motivational Interviewing for Depression combined with guideline-based medical management for depression
Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.
Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems."
644400|NCT01114334|O1|Outcome|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.
The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
644401|NCT01114334|O2|Outcome|Motivational Interview With GBMM|"Motivational Interviewing for Depression combined with guideline-based medical management for depression
Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.
Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems."
644645|NCT01114893|O1|Outcome|Travatan 0.004% QD|
644402|NCT01114334|O1|Outcome|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.
The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
644403|NCT01114334|O2|Outcome|Motivational Interview With GBMM|"Motivational Interviews combined with guideline-based medical management for depression
Guideline-Based Medical Management: We used the Colorado Clinical Guidelines Collaborative treatment guideline for Major Depression. It recommends treatment options e.g. specialty mental health counseling, antidepressant treatment, physical activity, depending upon presenting symptoms severity and other factors. The assessor notifies the clinician at the baseline visit about the patient's PHQ-9 depressive symptom severity score.
Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or"
644404|NCT01114334|O1|Outcome|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.
The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
644405|NCT01114334|E2|Reported Event|Motivational Interview With GBMM|"Motivational Interviewing for Depression combined with guideline-based medical management for depression
Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.
Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems."
644406|NCT01114334|E1|Reported Event|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.
The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
644607|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644409|NCT01114360|P1|Participant Flow|Placebo/Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of placebo for 4 weeks first, followed by 8 mg of time-released melatonin for 4 weeks.
644410|NCT01114360|O2|Outcome|Placebo|"African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of treatment with melatonin).
Patients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study."
644411|NCT01114360|O1|Outcome|Melatonin|"African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of treatment with placebo).
Patients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study."
644412|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between
644413|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.
644414|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks followed by 8mg time release melatonin for 4 weeks.
644415|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks followed by 4 weeks of placebo.
644416|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after exposure to 8mg time release melatonin for 4 weeks).
644417|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of placebo) in a crossover design.
644418|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8mg time release melatonin).
644511|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644419|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644420|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
644421|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644422|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks ((either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
644423|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644424|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
644425|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
644426|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
644427|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644428|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
644429|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644430|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
644431|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure placebo).
644432|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks either before or after 4 weeks of exposure to 8mg daily dose of time release melatonin).
644433|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after exposure to 4 weeks of placebo).
644434|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
644435|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644436|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
644437|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644438|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
644439|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644440|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
644441|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644442|NCT01114360|E2|Reported Event|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
644443|NCT01114360|E1|Reported Event|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644444|NCT01114373|B1|Baseline|All Subjects|African American subjects with mild to moderate essential hypertension received melatonin or placebo PO for the first 4 weeks then were switched to receive either placebo or melatonin PO therapy for an additional 4 weeks without any wash out period in between.
644646|NCT01114893|O5|Outcome|Travoprost Group C|
644445|NCT01114373|P2|Participant Flow|Melatonin/Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg daily of time-released melatonin at bed time for 4 weeks, followed by 24 mg of placebo at bed time for 4 week.
644446|NCT01114373|P1|Participant Flow|Placebo/Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg of placebo at bed time for 4 weeks followed by 24 mg time release melatonin at bed time for 4 weeks.
644447|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin) .
644448|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
644449|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
644450|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
644451|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
644452|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
644453|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
644454|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644455|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks(either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
644456|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644457|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
644458|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644459|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
644960|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644460|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
644461|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
644462|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
644463|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
644464|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644465|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
644466|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644467|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin).
644468|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644469|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin) .
644470|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
644471|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
644472|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
644473|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
644474|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644475|NCT01114373|E2|Reported Event|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin).
644476|NCT01114373|E1|Reported Event|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
644477|NCT01114581|B3|Baseline|Total|Total of all reporting groups
644478|NCT01114581|B2|Baseline|Placebo|Given as 2 tablets
644479|NCT01114581|B1|Baseline|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
644480|NCT01114581|P2|Participant Flow|Placebo|Given as 2 tablets
644481|NCT01114581|P1|Participant Flow|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
644482|NCT01114581|O2|Outcome|Placebo|Given as 2 tablets
644483|NCT01114581|O1|Outcome|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
644484|NCT01114581|O2|Outcome|Placebo|Given as 2 tablets
644485|NCT01114581|O1|Outcome|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
644486|NCT01114581|E2|Reported Event|Placebo|Given as 2 tablets
644487|NCT01114581|E1|Reported Event|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
644488|NCT01114672|B3|Baseline|Total|Total of all reporting groups
644489|NCT01114672|B2|Baseline|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
644490|NCT01114672|B1|Baseline|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
644491|NCT01114672|P2|Participant Flow|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
644492|NCT01114672|P1|Participant Flow|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
644493|NCT01114672|O2|Outcome|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
644494|NCT01114672|O1|Outcome|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
644495|NCT01114672|E2|Reported Event|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
644496|NCT01114672|E1|Reported Event|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
644961|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644497|NCT01114724|B1|Baseline|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644498|NCT01114724|P1|Participant Flow|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644499|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644500|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644501|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644502|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644503|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644504|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644505|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644506|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644507|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644508|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644509|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft will the Captivia Delivery System: All subjects will be implanted with this device
644510|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644512|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644513|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
644514|NCT01114724|E1|Reported Event|1. Dissection|Medtronic Dissection
644515|NCT01114737|B3|Baseline|Total|Total of all reporting groups
644516|NCT01114737|B2|Baseline|6R-BH4 20 mg/kg/Day|Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact). Patient will be treated for 26 weeks, the first 13 weeks were double-blinded randomized treatment period, the second 13 weeks open label treatment period
644517|NCT01114737|B1|Baseline|Placebo|Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study(double-blinded randomized treatment period); then treated with sapropterin dihydrochloride 20 mg/kg/day for an additional 13 weeks (open label treatment period).
644518|NCT01114737|P2|Participant Flow|6R-BH4 20 mg/kg/Day|Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact). Patient will be treated for 26 weeks, the first 13 weeks were double-blinded randomized treatment period, the second 13 weeks open label treatment period
644519|NCT01114737|P1|Participant Flow|Placebo|Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study(double-blinded randomized treatment period); then treated with sapropterin dihydrochloride 20 mg/kg/day for an additional 13 weeks (open label treatment period).
644520|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644521|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
644522|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644523|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
644524|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644525|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644526|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644527|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
644528|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644608|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644529|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
644530|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644531|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
644532|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
644533|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
644534|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644535|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
644536|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644537|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
644538|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644539|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
644540|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644541|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
644579|NCT01114880|B1|Baseline|Adalimumab|Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
644542|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644543|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
644544|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
644545|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
644546|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644547|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
644548|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644549|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644550|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644551|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644552|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644553|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644554|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644555|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
644556|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at Baseline
644557|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at Baseline
644558|NCT01114737|E8|Reported Event|6R-BH4 Treatment Period - Combined|6R-BH4 Combined Treatments - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
644609|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644559|NCT01114737|E7|Reported Event|6R-BH4 Treatment Period - 6R-BH4|6R-BH4 Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
644560|NCT01114737|E6|Reported Event|Open-Label Treatment Period - Overall|Open-label Treatment Period - All patients
644561|NCT01114737|E5|Reported Event|Open-Label Treatment Period - 6R-BH4|Open-label Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
644562|NCT01114737|E4|Reported Event|Open-Label Treatment Period - Placebo-6R-BH4|Open-label Treatment Period - Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
644563|NCT01114737|E3|Reported Event|Randomized Treatment Period - Overall|Randomized Treatment Period - All patients
644564|NCT01114737|E2|Reported Event|Randomized Treatment Period - 6R-BH4|Randomized Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
644565|NCT01114737|E1|Reported Event|Randomized Treatment Period - Placebo|Randomized Treatment Period - Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
644566|NCT01114828|B3|Baseline|Total|Total of all reporting groups
644567|NCT01114828|B2|Baseline|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
644568|NCT01114828|B1|Baseline|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
644569|NCT01114828|P2|Participant Flow|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
644570|NCT01114828|P1|Participant Flow|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
644571|NCT01114828|O2|Outcome|OPC-41061 7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
644572|NCT01114828|O1|Outcome|OPC-41061 3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
644573|NCT01114828|O2|Outcome|OPC-41061 7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
644574|NCT01114828|O1|Outcome|OPC-41061 3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
644575|NCT01114828|E2|Reported Event|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
644576|NCT01114828|E1|Reported Event|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
644577|NCT01114880|B3|Baseline|Total|Total of all reporting groups
644578|NCT01114880|B2|Baseline|Placebo|Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
644581|NCT01114880|P1|Participant Flow|Adalimumab|Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
644582|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644583|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644584|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644585|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644586|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644587|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644588|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644589|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644590|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644591|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644592|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644593|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644594|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644595|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644596|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644597|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644598|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644599|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644600|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644601|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644602|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644603|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644604|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644605|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644606|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644612|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644613|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644614|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644615|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644616|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644617|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644618|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644619|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644620|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644621|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644622|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644623|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644624|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644625|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
644626|NCT01114880|E4|Reported Event|Placebo/Adalimumab (Period 2)|Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded placebo from Week 0 to Week 10
644627|NCT01114880|E3|Reported Event|Adalimumab/Adalimumab (Period 2)|Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded adalimumab from Week 0 to Week 10
644628|NCT01114880|E2|Reported Event|Placebo (Period 1)|Blinded placebo from Week 0 to Week 10
644629|NCT01114880|E1|Reported Event|Adalimumab (Period 1)|Blinded adalimumab from Week 0 to Week 10
644630|NCT01114893|B6|Baseline|Total|Total of all reporting groups
644631|NCT01114893|B5|Baseline|Travoprost Group C|Travoprost Group C
644632|NCT01114893|B4|Baseline|Travoprost Group B|Travoprost Group B
644633|NCT01114893|B3|Baseline|Travoprost Group A|Travoprost Group A
644634|NCT01114893|B2|Baseline|Travoprost Vehicle|Travoprost Vehicle
644635|NCT01114893|B1|Baseline|TRAVATAN|TRAVATAN 0.004% once daily
644636|NCT01114893|P5|Participant Flow|Travoprost Group C|Travoprost Group C
644660|NCT01114945|B1|Baseline|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
644661|NCT01114945|P4|Participant Flow|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
644662|NCT01114945|P3|Participant Flow|McGrath|MacGrath
644663|NCT01114945|P2|Participant Flow|GlideScope|GlideScope device
644664|NCT01114945|P1|Participant Flow|Video-Mac|Video-Mac device
644665|NCT01114945|O4|Outcome|McGrath|MacGrath device
644666|NCT01114945|O3|Outcome|GlideScope|GlideScope device
644667|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
644668|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
644669|NCT01114945|O4|Outcome|McGrath|MacGrath device
644670|NCT01114945|O3|Outcome|GlideScope|GlideScope device
644671|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
644672|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
644673|NCT01114945|O4|Outcome|McGrath|MacGrath device
644674|NCT01114945|O3|Outcome|GlideScope|GlideScope device
644675|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
644676|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
644677|NCT01114945|O4|Outcome|McGrath|MacGrath device
644678|NCT01114945|O3|Outcome|GlideScope|GlideScope device
644679|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
644680|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
644715|NCT01114997|E1|Reported Event|Lidocaine|"Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
644716|NCT01115101|B3|Baseline|Total|Total of all reporting groups
644681|NCT01114945|E4|Reported Event|Direct Macintosh Laryngoscopy|"Direct Macintosh Laryngoscopy (DL) used during intubation procedure
McGrath: McGrath will be compared with:
Direct Macintosh Laryngoscopy Video-Mac GlideScope
GlideScope: GlideScope will be compared with:
Direct Macintosh Laryngoscopy Video-Mac and McGrath
Video-Mac: Video-Mac will be compared with:
Direct Macintosh Laryngoscopy GlideScope and McGrath"
644682|NCT01114945|E3|Reported Event|McGrath|"McGrath device used during intubation procedure
GlideScope: GlideScope will be compared with:
Direct Macintosh Laryngoscopy Video-Mac and McGrath
Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:
GlideScope Video-Mac and McGrath
Video-Mac: Video-Mac will be compared with:
Direct Macintosh Laryngoscopy GlideScope and McGrath"
644683|NCT01114945|E2|Reported Event|GlideScope|"GlideScope device used during intubation procedure
McGrath: McGrath will be compared with:
Direct Macintosh Laryngoscopy Video-Mac GlideScope
Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:
GlideScope Video-Mac and McGrath
Video-Mac: Video-Mac will be compared with:
Direct Macintosh Laryngoscopy GlideScope and McGrath"
644684|NCT01114945|E1|Reported Event|Video-Mac|"Video-Mac device used during intubation procedure
McGrath: McGrath will be compared with:
Direct Macintosh Laryngoscopy Video-Mac GlideScope
GlideScope: GlideScope will be compared with:
Direct Macintosh Laryngoscopy Video-Mac and McGrath
Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:
GlideScope Video-Mac and McGrath"
644685|NCT01114997|B4|Baseline|Total|Total of all reporting groups
644686|NCT01114997|B3|Baseline|Lidocaine + Esmolol (Combo)|"Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-Induction (Maintenance Infusion):
Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
644687|NCT01114997|B2|Baseline|Esmolol|"Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min"
644688|NCT01114997|B1|Baseline|Lidocaine|"Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
644689|NCT01114997|P3|Participant Flow|Lidocaine + Esmolol (Combo)|"Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
644690|NCT01114997|P2|Participant Flow|Esmolol|"Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min"
644691|NCT01114997|P1|Participant Flow|Lidocaine|"Pre-Induction:
Lidocaine Loading: 1 mg/kg Post- Induction:Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
644692|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
644693|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min"
644694|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
644695|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine (12.5-25 mcg/kg/min) + Esmolol (7.5-15 mcg/kg/min)"
644696|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min"
644697|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
644698|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
644699|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min"
644700|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
644701|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
644702|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min"
644703|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
644870|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644871|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644704|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
644705|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min"
644706|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
644707|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
644708|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min"
644709|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
644710|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
644711|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:
Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)
Post-Induction:
Infusion dose 7.5 - 15 mcg /kg/min"
644712|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:
Lidocaine Loading: 1 mg/kg
Post- Induction:
Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
644713|NCT01114997|E3|Reported Event|Lidocaine + Esmolol (Combo)|"Pre-induction:
Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)
Post-induction:
Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
644714|NCT01114997|E2|Reported Event|Esmolol|Pre-Induction: Loading dose 750 mcg/Kg (0.75 mg/kg) Post-Induction: Infusion dose 7.5 - 15 mcg /kg/min
644819|NCT01115660|B2|Baseline|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
644717|NCT01115101|B2|Baseline|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
644718|NCT01115101|B1|Baseline|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
644719|NCT01115101|P2|Participant Flow|Patient Controlled Device With Pritramid|Patients assigned to the Patient-controlled analgesia (PCA) group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
644720|NCT01115101|P1|Participant Flow|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after cesarean section (CS).
644721|NCT01115101|O2|Outcome|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
644722|NCT01115101|O1|Outcome|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
644723|NCT01115101|E2|Reported Event|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
644724|NCT01115101|E1|Reported Event|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
644725|NCT01115166|B1|Baseline|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
644726|NCT01115166|P1|Participant Flow|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
644727|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
644728|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
644729|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
644730|NCT01115166|E1|Reported Event|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
644731|NCT01115452|B1|Baseline|Overall Study|
644732|NCT01115452|P1|Participant Flow|5% or 2.5% Potassium Nitrate Solution or Water|Investigator applied the participants with 5% potassium nitrate solution or 2.5% potassium nitrate solution or water to a single sensitive tooth for two minutes (mins), in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644733|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644734|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644735|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644736|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644872|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644873|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644737|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644738|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644739|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644740|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644741|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644742|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644743|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644808|NCT01115569|E1|Reported Event|Conversion/Titration Phase|Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release (HC-ER) capsules daily for up to 6 weeks
644744|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644745|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644746|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644747|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644748|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644749|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644750|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644751|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644752|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644753|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644754|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644755|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment..
644756|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644757|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644758|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644759|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644760|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644761|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644762|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644763|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644764|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644765|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644766|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644809|NCT01115582|B1|Baseline|Cholic Acid|All patients entered and treated
644810|NCT01115582|P1|Participant Flow|Cholic Acid|All patients entered and treated
644767|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644768|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644769|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644770|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644771|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644772|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644773|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644774|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644775|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644776|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644777|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644778|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment
644779|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
644780|NCT01115452|E1|Reported Event|Overall Study|
644781|NCT01115491|B1|Baseline|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
644799|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
644782|NCT01115491|P1|Participant Flow|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg per square meter (mg/m^2), orally (PO), on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
644783|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
644784|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
644785|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
644811|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
644812|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
644813|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
644786|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
644787|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
644788|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
644789|NCT01115491|E1|Reported Event|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
644790|NCT01115517|B3|Baseline|Total|Total of all reporting groups
644791|NCT01115517|B2|Baseline|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
644792|NCT01115517|B1|Baseline|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
644793|NCT01115517|P2|Participant Flow|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
644794|NCT01115517|P1|Participant Flow|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
644795|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
644796|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
644797|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
644798|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
644869|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644800|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
644801|NCT01115517|E2|Reported Event|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
644802|NCT01115517|E1|Reported Event|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
644803|NCT01115569|B1|Baseline|Open-label Hydrocodone Bitartate Extended Release (HC-ER)|Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks
644804|NCT01115569|P2|Participant Flow|Open-label Hydrocodone Bitartrate Extended Release Capsules|"Maintenance HC-ER Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-ER in a flexible dosing regimen.
Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
644805|NCT01115569|P1|Participant Flow|Open-label Hydrocodone Bitartrate Extended Release (HC-ER)|Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks
644806|NCT01115569|O1|Outcome|Open-label Hydrocodone Bitartrate Extended Release Capsules|"Maintenance HC-ER Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.
Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
644807|NCT01115569|E2|Reported Event|Maintenance Treatment Phase|"Maintenance Hydrocodone Bitartrate Extended Release (HC-ER) Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.
Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
644820|NCT01115660|B1|Baseline|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
644821|NCT01115660|P2|Participant Flow|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
644822|NCT01115660|P1|Participant Flow|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
644823|NCT01115660|O2|Outcome|Control|standard of care
644824|NCT01115660|O1|Outcome|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
644825|NCT01115660|O2|Outcome|Control|standard of care
644826|NCT01115660|O1|Outcome|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
644827|NCT01115660|E2|Reported Event|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
644828|NCT01115660|E1|Reported Event|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
644829|NCT01115673|B4|Baseline|Total|Total of all reporting groups
644830|NCT01115673|B3|Baseline|ACE-0|0 mg Acetaminophen Caplet
644831|NCT01115673|B2|Baseline|ACE-650|650 mg Acetaminophen Caplet
644832|NCT01115673|B1|Baseline|ACE-1000|1000 mg Acetaminophen Caplet
644833|NCT01115673|P3|Participant Flow|ACE-0|0 mg Acetaminophen Caplet
644834|NCT01115673|P2|Participant Flow|ACE-650|650 mg Acetaminophen Caplet
644835|NCT01115673|P1|Participant Flow|ACE-1000|1000 mg Acetaminophen Caplet
644836|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644837|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644838|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644839|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644840|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644841|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644842|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644843|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644844|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644845|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644846|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644847|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644848|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644849|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644850|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644851|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644852|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644853|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644854|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644855|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644856|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644857|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644858|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644859|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644860|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644861|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644862|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644863|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644864|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644865|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644866|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644867|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644868|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644874|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644875|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644876|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644877|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644878|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644879|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644880|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644881|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644882|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644883|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644884|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644885|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644886|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644887|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644888|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644889|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644890|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644891|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644892|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644893|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644894|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644895|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644896|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644962|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
644963|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
644964|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
644965|NCT01115673|E3|Reported Event|ACE-0|0 mg Acetaminophen Caplet
644966|NCT01115673|E2|Reported Event|ACE-650|650 mg Acetaminophen Caplet
644967|NCT01115673|E1|Reported Event|ACE-1000|1000 mg Acetaminophen Caplet
644968|NCT01115699|B1|Baseline|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
644969|NCT01115699|P1|Participant Flow|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
644970|NCT01115699|O1|Outcome|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
644971|NCT01115699|O1|Outcome|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
644972|NCT01115699|E1|Reported Event|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
644973|NCT01115738|B4|Baseline|Total|Total of all reporting groups
644974|NCT01115738|B3|Baseline|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644975|NCT01115738|B2|Baseline|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644976|NCT01115738|B1|Baseline|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644977|NCT01115738|P3|Participant Flow|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644978|NCT01115738|P2|Participant Flow|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644979|NCT01115738|P1|Participant Flow|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644980|NCT01115738|O6|Outcome|600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM|CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644981|NCT01115738|O5|Outcome|600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM|CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644982|NCT01115738|O4|Outcome|600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM|CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645103|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645104|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
644983|NCT01115738|O3|Outcome|600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 EM|CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644984|NCT01115738|O2|Outcome|Placebo and 60 mg Prasugrel -CYP2C19 RM|CYP2C19 reduced metabolizers treated with placebo LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644985|NCT01115738|O1|Outcome|Placebo and 60 mg Prasugrel-CYP2C19 EM|CYP2C19 extensive metabolizers treated with placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644986|NCT01115738|O2|Outcome|Clopidogrel at Baseline - CYP2C19 RM|600-mg clopidogrel LD administered once orally before PCI.
644987|NCT01115738|O1|Outcome|Clopidogrel at Baseline -CYP2C19 EM|600-milligram (mg) clopidogrel loading dose (LD) administered once orally before percutaneous coronary intervention (PCI).
644988|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644989|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645066|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
644990|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644991|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644992|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644993|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644994|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644995|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644996|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644997|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644998|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
644999|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645000|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645001|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645002|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645003|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645004|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645005|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645006|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645007|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645008|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645009|NCT01115738|E3|Reported Event|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645010|NCT01115738|E2|Reported Event|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645011|NCT01115738|E1|Reported Event|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
645012|NCT01115855|B3|Baseline|Total|Total of all reporting groups
645118|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645013|NCT01115855|B2|Baseline|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645014|NCT01115855|B1|Baseline|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645015|NCT01115855|P2|Participant Flow|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645016|NCT01115855|P1|Participant Flow|Eplerenone|Participants with estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 50 milliliter per minute divided by 1.73 squared meter (mL/min/1.73m^2) received eplerenone 25 milligram (mg) tablet once daily up to Week 4 and participants with eGFR 30 to less than (<) 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. . From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645017|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645018|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645019|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645020|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645021|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645022|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645023|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645041|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645024|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645025|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645026|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645027|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645028|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645029|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645030|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645031|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645032|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645033|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645034|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645035|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645036|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645037|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645038|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645039|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645040|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645102|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645042|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645043|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645044|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645045|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645046|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645119|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645047|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645048|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645049|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645050|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645051|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645052|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645053|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645054|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645055|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645056|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645057|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645058|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645059|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645060|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645061|NCT01115855|E2|Reported Event|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
645062|NCT01115855|E1|Reported Event|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
645063|NCT01115933|B1|Baseline|XIENCE PRIME SV EECSS|"XIENCE PRIME SV Everolimus Eluting Coronary Stent System
XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS"
645064|NCT01115933|P1|Participant Flow|XIENCE PRIME SV EECSS|"XIENCE PRIME SV EECSS: XIENCE PRIME Small Vessel (2.25 mm) Everolimus Eluting Coronary Stent System
XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS"
645065|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645067|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|"XIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System
XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS"
645068|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645069|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645070|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645071|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645072|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645073|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS- ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645074|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645075|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645076|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645077|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645078|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645079|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645080|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645081|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645082|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645083|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645084|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645085|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
645086|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645087|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645088|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645089|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645090|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645091|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645092|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645093|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645094|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645095|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645096|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645097|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645098|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645099|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645100|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645101|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645105|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645106|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645107|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645108|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645109|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645110|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645111|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NTV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645112|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - NTV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645113|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NTV-NQMI Per Protocol|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645114|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - NTV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645115|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per ARC|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645116|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645117|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645120|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645121|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645122|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645123|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645124|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645125|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645126|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS- TV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645127|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645128|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - QMI Per ARC|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645129|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
645130|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645131|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NQMI Per ARC Definitions|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645132|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - QMI Per ARC Definitions|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
645133|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645134|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645135|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - Non-Cardiovascular Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS
645136|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - Vascular Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645137|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - Cardiac Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645138|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - All Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645139|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - Non-Cardiovascular|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
645140|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - Vascular|XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS
645141|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - Cardiac|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645142|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS ABR Distal|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
645143|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS ABR Proximal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645144|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS ABR In-stent|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645145|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS ABR In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645146|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS LL Distal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645147|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS LL Proximal|XIENCE PRIME SV EECSS: Patients receivingXIENCE PRIME SV EECSS
645148|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS LL In-stent|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645149|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS LL In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645150|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS %DS Distal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645151|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS %DS Proximal|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645152|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS %DS In-stent|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
645153|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS %DS In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645154|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS EECSS : Patients receiving XIENCE PRIME SV EECSS
645155|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645156|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
645183|NCT01116024|O4|Outcome|2 Years|Effective Orifice Area at 2 years
645157|NCT01115933|E1|Reported Event|AVJ-09-385 SV EECSS|"SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System
AVJ-09-385 EECSS : Patients receiving AVJ-09-385 EECSS"
645158|NCT01115998|B3|Baseline|Total|Total of all reporting groups
645159|NCT01115998|B2|Baseline|Control Group|Children received usual early intervention services, but no power wheelchair.
645160|NCT01115998|B1|Baseline|Power Wheelchair|
645161|NCT01115998|P2|Participant Flow|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
645162|NCT01115998|P1|Participant Flow|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
645163|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
645262|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
645164|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
645165|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
645166|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
645167|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
645168|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
645169|NCT01115998|E2|Reported Event|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
645170|NCT01115998|E1|Reported Event|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
645171|NCT01116024|B1|Baseline|Aortic Valve Replacement|3f Enable Aortic Bioprosthesis Model 6000
645172|NCT01116024|P1|Participant Flow|ATS 3f Enable Aortic Bioprosthesis Model 6000|ATS 3f Enable Aortic Bioprosthesis Model 6000 : Replacement Aortic Heart Valve
645173|NCT01116024|O7|Outcome|5 Years|Effective Orifice Area at 5 years
645174|NCT01116024|O6|Outcome|4 Years|Effective Orifice Area at 4 years
645175|NCT01116024|O5|Outcome|3 Years|Effective Orifice Area at 3 years
645176|NCT01116024|O4|Outcome|2 Years|Effective Orifice Area at 2 years
645177|NCT01116024|O3|Outcome|11-14 Months|Effective Orifice Area at 11-14 months
645178|NCT01116024|O2|Outcome|3-6 Months|Effective Orifice Area at 3-6 months
645179|NCT01116024|O1|Outcome|Discharge|Effective Orifice Area at discharge
645180|NCT01116024|O7|Outcome|5 Years|Effective Orifice Area at 5 years
645181|NCT01116024|O6|Outcome|4 Years|Effective Orifice Area at 4 years
645182|NCT01116024|O5|Outcome|3 Years|Effective Orifice Area at 3 years
645184|NCT01116024|O3|Outcome|11-14 Months|Effective Orifice Area at 11-14 months
645185|NCT01116024|O2|Outcome|3-6 Months|Effective Orifice Area at 3-6 months
645186|NCT01116024|O1|Outcome|Discharge|Effective Orifice Area at discharge
645187|NCT01116024|O7|Outcome|5 Years|Gradient at 5 Years
645188|NCT01116024|O6|Outcome|4 Years|Gradient at 4 Years
645189|NCT01116024|O5|Outcome|3 Years|Gradient at 3 Years
645190|NCT01116024|O4|Outcome|2 Years|Gradient at 2 Years
645191|NCT01116024|O3|Outcome|11-14 Months|Gradient at 11-14 months
645192|NCT01116024|O2|Outcome|3-6 Months|Gradient at 3-6 Months
645193|NCT01116024|O1|Outcome|Discharge|Gradient at discharge
645194|NCT01116024|O7|Outcome|NYHA Class 5 Year|NYHA classification after 5 years.
645195|NCT01116024|O6|Outcome|NYHA Class 4 Year|NYHA classification after 4 years.
645196|NCT01116024|O5|Outcome|NYHA Class 3 Year|NYHA classification after 3 years.
645197|NCT01116024|O4|Outcome|NYHA Class 2 Year|NYHA classification after 2 years.
645198|NCT01116024|O3|Outcome|NYHA Class 11-14 Months|NYHA classification after 11-14 months.
645199|NCT01116024|O2|Outcome|NYHA Class 3-6 Months|NYHA classification after 3-6 months.
645200|NCT01116024|O1|Outcome|NYHA Class Preoperative|Preoperative numbers of NYHA classification.
645201|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
645202|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
645203|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
645204|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
645205|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
645206|NCT01116024|O1|Outcome|Enable I Model 6000 Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
645207|NCT01116024|O1|Outcome|Enable I Model 6000 Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
645208|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
645209|NCT01116024|E1|Reported Event|Enable I Model 6000 Valve|Adverse events relating to the study safety endpoints.
645210|NCT01116037|B1|Baseline|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)
ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
645211|NCT01116037|P1|Participant Flow|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)
ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
645212|NCT01116037|O1|Outcome|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)
ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
645213|NCT01116037|O1|Outcome|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)
ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
645214|NCT01116037|E1|Reported Event|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)
ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
645215|NCT01116102|B9|Baseline|Total|Total of all reporting groups
645216|NCT01116102|B8|Baseline|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
645217|NCT01116102|B7|Baseline|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
645218|NCT01116102|B6|Baseline|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
645219|NCT01116102|B5|Baseline|25 ga Needle, Dose Flush, Single-step Rate Scheme|
645220|NCT01116102|B4|Baseline|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
645221|NCT01116102|B3|Baseline|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
645222|NCT01116102|B2|Baseline|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
645223|NCT01116102|B1|Baseline|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
645224|NCT01116102|P8|Participant Flow|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
645225|NCT01116102|P7|Participant Flow|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
645226|NCT01116102|P6|Participant Flow|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
645227|NCT01116102|P5|Participant Flow|25 ga Needle, Dose Flush, Single-step Rate Scheme|
645228|NCT01116102|P4|Participant Flow|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
645229|NCT01116102|P3|Participant Flow|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
645230|NCT01116102|P2|Participant Flow|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
645231|NCT01116102|P1|Participant Flow|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
645232|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
645233|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
645234|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
645235|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
645236|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
645237|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
645238|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
645239|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
645240|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
645241|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
645242|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
645243|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
645244|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
645245|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
645246|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
645247|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
645248|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
645249|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
645250|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
645251|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
645252|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
645253|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
645254|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
645255|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
645256|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
645257|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
645258|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
645259|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
645260|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
645261|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
645263|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
645264|NCT01116102|E8|Reported Event|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
645265|NCT01116102|E7|Reported Event|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
645266|NCT01116102|E6|Reported Event|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
645267|NCT01116102|E5|Reported Event|25 ga Needle, Dose Flush, Single-step Rate Scheme|
645268|NCT01116102|E4|Reported Event|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
645269|NCT01116102|E3|Reported Event|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
645270|NCT01116102|E2|Reported Event|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
645271|NCT01116102|E1|Reported Event|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
645272|NCT01116232|B1|Baseline|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter
Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;
For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
peripheral blood stem cell transplantation
sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
645273|NCT01116232|P1|Participant Flow|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter
Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;
For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
peripheral blood stem cell transplantation
sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
645274|NCT01116232|O1|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter
Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour
Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose."
645275|NCT01116232|O1|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter
Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;
For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
peripheral blood stem cell transplantation
sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
645276|NCT01116232|E1|Reported Event|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter
Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;
For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
peripheral blood stem cell transplantation
sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
645277|NCT01116427|B3|Baseline|Total|Total of all reporting groups
646350|NCT01119222|E2|Reported Event|Morphine|Morphine single IV 10 mg dose
645278|NCT01116427|B2|Baseline|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645279|NCT01116427|B1|Baseline|Abatacept First, Then Placebo|Subjects received abatacept IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows: Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645280|NCT01116427|P2|Participant Flow|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645350|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645351|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645281|NCT01116427|P1|Participant Flow|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645282|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645283|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645284|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645285|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645286|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645287|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645288|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645289|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645290|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645337|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
646570|NCT01119937|O1|Outcome|NVA237|50µg once daily
645291|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645292|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645293|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645294|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645295|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645296|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645297|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645298|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645299|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645300|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645301|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645302|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645303|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645304|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645305|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645306|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645307|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645308|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645309|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
645310|NCT01116427|E6|Reported Event|Follow-up Phase: Placebo -> Abatacept|Following Week 52, participants in the Placebo -> Abatacept group completed an additional 12 weeks of observation until week 64.
645311|NCT01116427|E5|Reported Event|Follow-up Phase: Abatacept -> Placebo|Following Week 52, participants in the Abatacept -> Placebo group completed an additional 12 weeks of observation until week 64.
645312|NCT01116427|E4|Reported Event|Extension Phase: Placebo -> Abatacept|"After week 24, participants in the Placebo -> Abatacept group eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Dosing of abatacept was as follows:
Participants weighing-
less than 60 kg received 500 mg;
60-100 kg received 750 mg; and
greater than 100 kg received 1 g."
645313|NCT01116427|E3|Reported Event|Extension Phase: Abatacept -> Placebo|After week 24, participants in Abatacept -> Placebo group eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52.
645314|NCT01116427|E2|Reported Event|Core Phase: Placebo -> Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24.
645315|NCT01116427|E1|Reported Event|Core Phase: Abatacept -> Placebo|"Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. Dosing of abatacept was as follows:
Participants weighing-
less than 60 kg received 500 mg;
60-100 kg received 750 mg; and
greater than 100 kg received 1 g."
645316|NCT01116466|B1|Baseline|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
645317|NCT01116466|P1|Participant Flow|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
645318|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
645319|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
645320|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
645321|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
645322|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
645323|NCT01116466|E1|Reported Event|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
645324|NCT01116687|B1|Baseline|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
645325|NCT01116687|P1|Participant Flow|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
645326|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
645327|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
645328|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
645329|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
645330|NCT01116687|E1|Reported Event|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
645331|NCT01116882|B3|Baseline|Total|Total of all reporting groups
645332|NCT01116882|B2|Baseline|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645333|NCT01116882|B1|Baseline|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645334|NCT01116882|P2|Participant Flow|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645335|NCT01116882|P1|Participant Flow|PCI at a Hospital Without On-site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645336|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645338|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645339|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645340|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645341|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645342|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645343|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645344|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645345|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645346|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
645347|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
645348|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
645349|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
645352|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
645353|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
645354|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645355|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645356|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645357|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645358|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645359|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery.
645360|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645361|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645362|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645363|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645364|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645365|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645366|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645367|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645368|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
645369|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
645370|NCT01116882|E2|Reported Event|Surgery-On-Site (SOS)|Patients randomized to the SOS arm are transferred to tertiary hospitals for their PCI procedure.
645371|NCT01116882|E1|Reported Event|Non-Surgery-On-Site (Non-SOS)|Patients in the non-SOS arm are randomized to stay at the community hospitals for their PCI procedure.
645372|NCT01116921|B3|Baseline|Total|Total of all reporting groups
645373|NCT01116921|B2|Baseline|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
645374|NCT01116921|B1|Baseline|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
645375|NCT01116921|P2|Participant Flow|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
645376|NCT01116921|P1|Participant Flow|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
645377|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
645378|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
645379|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
645380|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
646571|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
645381|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
645382|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
645383|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
645384|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
645385|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
645386|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
645387|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
645388|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
645389|NCT01116921|E2|Reported Event|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
645390|NCT01116921|E1|Reported Event|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
645391|NCT01116934|B3|Baseline|Total|Total of all reporting groups
645392|NCT01116934|B2|Baseline|Healthy Controls|9 healthy donors
645393|NCT01116934|B1|Baseline|PLS Patients|8 PLS patients (one female) from 6 families
645394|NCT01116934|P2|Participant Flow|Healthy Controls|9 healthy donors
645395|NCT01116934|P1|Participant Flow|Papillon-Lefèvre Syndrome (PLS) Patients|8 PLS patients (one female) from 6 families
645396|NCT01116934|O2|Outcome|Healthy Controls|9 healthy donors
645397|NCT01116934|O1|Outcome|Papillon-Lefèvre Syndrome (PLS) Patients|8 PLS patients (one female) from 6 families
645398|NCT01116934|E2|Reported Event|Healthy Controls|9 healthy donors
645399|NCT01116934|E1|Reported Event|PLS Patients|8 PLS patients (one female) from 6 families
645400|NCT01116986|B33|Baseline|Total|Total of all reporting groups
645401|NCT01116986|B32|Baseline|32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645402|NCT01116986|B31|Baseline|31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645403|NCT01116986|B30|Baseline|30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645404|NCT01116986|B29|Baseline|29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645405|NCT01116986|B28|Baseline|28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645406|NCT01116986|B27|Baseline|27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645407|NCT01116986|B26|Baseline|26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645408|NCT01116986|B25|Baseline|25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645493|NCT01116986|E2|Reported Event|Pre-Quit Nicotine Patch|"Pre-Quit Nicotine Patch
Participants randomized to this condition received Pre-Quit Nicotine Patch.
Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day."
645409|NCT01116986|B24|Baseline|24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645410|NCT01116986|B23|Baseline|23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645411|NCT01116986|B22|Baseline|22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645412|NCT01116986|B21|Baseline|21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645413|NCT01116986|B20|Baseline|20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk|How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
645523|NCT01117051|E2|Reported Event|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
645524|NCT01117051|E1|Reported Event|Placebo|once daily before breakfast for up to 12 weeks
645414|NCT01116986|B19|Baseline|19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt."
645415|NCT01116986|B18|Baseline|18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645416|NCT01116986|B17|Baseline|17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645417|NCT01116986|B16|Baseline|16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645418|NCT01116986|B15|Baseline|15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645419|NCT01116986|B14|Baseline|14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645420|NCT01116986|B13|Baseline|13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645421|NCT01116986|B12|Baseline|12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645422|NCT01116986|B11|Baseline|11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645423|NCT01116986|B10|Baseline|10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645424|NCT01116986|B9|Baseline|9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645425|NCT01116986|B8|Baseline|8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645501|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645426|NCT01116986|B7|Baseline|7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645427|NCT01116986|B6|Baseline|6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645428|NCT01116986|B5|Baseline|5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645429|NCT01116986|B4|Baseline|4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645430|NCT01116986|B3|Baseline|3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645431|NCT01116986|B2|Baseline|2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645432|NCT01116986|B1|Baseline|1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645433|NCT01116986|P32|Participant Flow|32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645434|NCT01116986|P31|Participant Flow|31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645435|NCT01116986|P30|Participant Flow|30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645436|NCT01116986|P29|Participant Flow|29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645437|NCT01116986|P28|Participant Flow|28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645438|NCT01116986|P27|Participant Flow|27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645439|NCT01116986|P26|Participant Flow|26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645440|NCT01116986|P25|Participant Flow|25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645441|NCT01116986|P24|Participant Flow|24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645442|NCT01116986|P23|Participant Flow|23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645502|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
646351|NCT01119222|E1|Reported Event|Gabapentin|Gabapentin single oral 1200 mg dose
645443|NCT01116986|P22|Participant Flow|22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645444|NCT01116986|P21|Participant Flow|21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645445|NCT01116986|P20|Participant Flow|20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk|How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
645446|NCT01116986|P19|Participant Flow|19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt."
645447|NCT01116986|P18|Participant Flow|18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645448|NCT01116986|P17|Participant Flow|17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645525|NCT01110499|B9|Baseline|Total|Total of all reporting groups
645526|NCT01110499|B8|Baseline|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
645449|NCT01116986|P16|Participant Flow|16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645450|NCT01116986|P15|Participant Flow|15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645451|NCT01116986|P14|Participant Flow|14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645452|NCT01116986|P13|Participant Flow|13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645453|NCT01116986|P12|Participant Flow|12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645454|NCT01116986|P11|Participant Flow|11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645455|NCT01116986|P10|Participant Flow|10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645456|NCT01116986|P9|Participant Flow|9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645457|NCT01116986|P8|Participant Flow|8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645458|NCT01116986|P7|Participant Flow|7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645459|NCT01116986|P6|Participant Flow|6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645460|NCT01116986|P5|Participant Flow|5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645461|NCT01116986|P4|Participant Flow|4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645462|NCT01116986|P3|Participant Flow|3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645463|NCT01116986|P2|Participant Flow|2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
645464|NCT01116986|P1|Participant Flow|1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
645527|NCT01110499|B7|Baseline|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
645528|NCT01110499|B6|Baseline|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645529|NCT01110499|B5|Baseline|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645901|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
645465|NCT01116986|O12|Outcome|Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
645466|NCT01116986|O11|Outcome|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
645467|NCT01116986|O10|Outcome|Intensive Phone Counseling During the Quit Attempt|Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
645468|NCT01116986|O9|Outcome|Minimal Phone Counseling During the Quit Attemp|Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
645494|NCT01116986|E1|Reported Event|Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch|"Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch
Participants randomized to this condition received Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch.
Before quitting: Everyone had ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day."
645495|NCT01117012|B3|Baseline|Total|Total of all reporting groups
645496|NCT01117012|B2|Baseline|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
646352|NCT01119287|B7|Baseline|Total|Total of all reporting groups
645469|NCT01116986|O8|Outcome|Intensive In-person Counseling During the Quit Attempt|Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
645470|NCT01116986|O7|Outcome|Minimal In-person Counseling During the Quit Attempt|Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
645471|NCT01116986|O6|Outcome|Counseling Before the Quit Attempt|Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
645530|NCT01110499|B4|Baseline|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645531|NCT01110499|B3|Baseline|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645902|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
645472|NCT01116986|O5|Outcome|No Counseling Before the Quit Attempt|Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
645473|NCT01116986|O4|Outcome|Pre-Quit Nicotine Gum|Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
645474|NCT01116986|O3|Outcome|No Pre-Quit Nicotine Gum|Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
645475|NCT01116986|O2|Outcome|Pre-Quit Nicotine Patch|Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
645497|NCT01117012|B1|Baseline|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645476|NCT01116986|O1|Outcome|No Pre-Quit Nicotine Patch|Participants randomized to this condition received No Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Patch group consists of 308 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Patch (N=329; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
645477|NCT01116986|O12|Outcome|Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
645478|NCT01116986|O11|Outcome|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
645486|NCT01116986|O3|Outcome|No Pre-Quit Nicotine Gum|Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
645479|NCT01116986|O10|Outcome|Intensive Phone Counseling During the Quit Attempt|Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
645480|NCT01116986|O9|Outcome|Minimal Phone Counseling During the Quit Attemp|Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
645481|NCT01116986|O8|Outcome|Intensive In-person Counseling During the Quit Attempt|Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
645498|NCT01117012|P2|Participant Flow|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645499|NCT01117012|P1|Participant Flow|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 milligram (mg) tablet orally twice daily (q12h).
645500|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
646572|NCT01119937|O1|Outcome|NVA237|50µg once daily
645482|NCT01116986|O7|Outcome|Minimal In-person Counseling During the Quit Attempt|Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
645483|NCT01116986|O6|Outcome|Counseling Before the Quit Attempt|Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
645484|NCT01116986|O5|Outcome|No Counseling Before the Quit Attempt|Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
645485|NCT01116986|O4|Outcome|Pre-Quit Nicotine Gum|Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
645519|NCT01117051|O1|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
645520|NCT01117051|O1|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
645521|NCT01117051|O2|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
645522|NCT01117051|O1|Outcome|Placebo|once daily before breakfast for up to 12 weeks
649325|NCT01127256|B3|Baseline|Total|Total of all reporting groups
645487|NCT01116986|O2|Outcome|Pre-Quit Nicotine Patch|Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
645488|NCT01116986|O1|Outcome|No Pre-Quit Nicotine Patch|Participants randomized to this condition received No Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Patch group consists of 308 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Patch (N=329; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
645489|NCT01116986|E6|Reported Event|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|"Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum
Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt."
645490|NCT01116986|E5|Reported Event|Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum|"Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum
Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt."
645491|NCT01116986|E4|Reported Event|No Pre-Quit Nicotine Patch Nor Gum|"No Pre-Quit Nicotine Patch nor Gum
Participants randomized to this condition received neither the Pre-Quit Nicotine Patch nor the Pre-Quit Nicotine Gum."
645492|NCT01116986|E3|Reported Event|Pre-Quit Nicotine Gum|"Pre-Quit Nicotine Gum
Participants randomized to this condition received Pre-Quit Nicotine Gum.
Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day."
646573|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
645503|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645504|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645505|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645506|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645507|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645508|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645509|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645510|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645511|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
645512|NCT01117012|O1|Outcome|VX-770|All participants who received VX-770 150 mg tablet orally q12h in Study 105.
645513|NCT01117012|E1|Reported Event|VX-770|All participants who received VX-770 150 mg tablet orally q12h in Study 105.
645514|NCT01117051|B3|Baseline|Total|Total of all reporting groups
645515|NCT01117051|B2|Baseline|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
645516|NCT01117051|B1|Baseline|Placebo|placebo once daily before breakfast for up to 12 weeks
645517|NCT01117051|P2|Participant Flow|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
645518|NCT01117051|P1|Participant Flow|Placebo|placebo once daily before breakfast for up to 12 weeks
645532|NCT01110499|B2|Baseline|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645533|NCT01110499|B1|Baseline|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645534|NCT01110499|P8|Participant Flow|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
645535|NCT01110499|P7|Participant Flow|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
645536|NCT01110499|P6|Participant Flow|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645537|NCT01110499|P5|Participant Flow|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645538|NCT01110499|P4|Participant Flow|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645539|NCT01110499|P3|Participant Flow|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645540|NCT01110499|P2|Participant Flow|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645541|NCT01110499|P1|Participant Flow|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645542|NCT01110499|O2|Outcome|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
645543|NCT01110499|O1|Outcome|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
645544|NCT01110499|O7|Outcome|Part 1, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in the other eye in all Part 1 treatment groups once daily for 7 days.
645545|NCT01110499|O6|Outcome|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye once daily for 7 days.
645546|NCT01110499|O5|Outcome|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye once daily for 7 days.
645547|NCT01110499|O4|Outcome|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye once daily for 7 days.
645548|NCT01110499|O3|Outcome|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye once daily for 7 days.
645549|NCT01110499|O2|Outcome|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye once daily for 7 days.
645550|NCT01110499|O1|Outcome|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye once daily for 7 days.
645551|NCT01110499|E9|Reported Event|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
645552|NCT01110499|E8|Reported Event|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
645553|NCT01110499|E7|Reported Event|Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye|bimatoprost ophthalmic solution 0.03% in the non-study eye once daily for 7 days (all bimatoprost ophthalmic solution 0.03% treated eyes in Part 1 combined).
645554|NCT01110499|E6|Reported Event|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645555|NCT01110499|E5|Reported Event|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645556|NCT01110499|E4|Reported Event|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645557|NCT01110499|E3|Reported Event|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645558|NCT01110499|E2|Reported Event|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645559|NCT01110499|E1|Reported Event|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
645560|NCT01110915|B3|Baseline|Total|Total of all reporting groups
645561|NCT01110915|B2|Baseline|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
645562|NCT01110915|B1|Baseline|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
645563|NCT01110915|P2|Participant Flow|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
645564|NCT01110915|P1|Participant Flow|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
645565|NCT01110915|O1|Outcome|Implanted Subjects|Any subject who underwent a successful implant of the Advisa MRI system.
645566|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
645567|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
645568|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
645569|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
645570|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
645571|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
646603|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
645572|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
645573|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
645574|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
645575|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
645576|NCT01110915|E2|Reported Event|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
645577|NCT01110915|E1|Reported Event|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
645578|NCT01110967|B1|Baseline|Patients Implanted With a Satellite Device|
645579|NCT01110967|P1|Participant Flow|Patients Implanted With a Satellite Device|
645580|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
645581|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
645582|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
645583|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
645584|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
645585|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
645586|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
645587|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
645588|NCT01110967|E1|Reported Event|Patients Implanted With a Satellite Device|
645589|NCT01111110|B3|Baseline|Total|Total of all reporting groups
645590|NCT01111110|B2|Baseline|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
645591|NCT01111110|B1|Baseline|Anti-static/Static|albuterol with anti-static chamber then Static on another night
645592|NCT01111110|P2|Participant Flow|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
645593|NCT01111110|P1|Participant Flow|Anti-static/Static|albuterol with anti-static chamber then Static on another night
645594|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
645595|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
645596|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
645597|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
645598|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
645599|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
645600|NCT01111110|E2|Reported Event|Antistatic|albuterol with antistatic chamber.
645601|NCT01111110|E1|Reported Event|Static|albuterol with static chamber
645602|NCT01111123|B3|Baseline|Total|Total of all reporting groups
645603|NCT01111123|B2|Baseline|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
645604|NCT01111123|B1|Baseline|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
645605|NCT01111123|P2|Participant Flow|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
645606|NCT01111123|P1|Participant Flow|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
645607|NCT01111123|O2|Outcome|Lac-hydrin + Placebo|lac hydrin twice daily everyday plus placebo ointment twice daily weekends only
645608|NCT01111123|O1|Outcome|Lac-hydrin + Ultravate|ammonium lactate twice daily everyday + ultravate twice daily weekends only
645609|NCT01111123|O2|Outcome|Ammoium Lactate + Placebo|ammonium lactate twice daily everyday plus placebo ointment twice daily weekends only
645610|NCT01111123|O1|Outcome|Ammonium Lactate + Ultravate|ammonium lactate twice daily everyday plus ultravte ointment twice daily on weekends only for up to 24 weeks
645611|NCT01111123|E2|Reported Event|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
645612|NCT01111123|E1|Reported Event|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
645613|NCT01111149|B4|Baseline|Total|Total of all reporting groups
645614|NCT01111149|B3|Baseline|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645615|NCT01111149|B2|Baseline|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645616|NCT01111149|B1|Baseline|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645634|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
656506|NCT01146457|E3|Reported Event|Morphine 50|Morphine: Active dosage
645617|NCT01111149|P3|Participant Flow|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645618|NCT01111149|P2|Participant Flow|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645619|NCT01111149|P1|Participant Flow|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645620|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645621|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645622|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645623|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645624|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645625|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645626|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645627|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
646574|NCT01119937|O1|Outcome|NVA237|50µg once daily
645628|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645629|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645630|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645631|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645632|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645633|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645635|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645636|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645637|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645638|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645639|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645640|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645641|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645642|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645643|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645644|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645645|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645646|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645647|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645648|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645649|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645650|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645651|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645652|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645653|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645654|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645655|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645656|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645657|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645658|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645659|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645660|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645661|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645662|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645702|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645663|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645664|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645665|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645666|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645667|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645668|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645716|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645669|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645670|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645671|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645672|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645673|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645674|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645675|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645676|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645677|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645678|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645703|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
646575|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
645679|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645680|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645681|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645682|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645683|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645684|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645685|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645898|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
645686|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645687|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645688|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645689|NCT01111149|E3|Reported Event|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
645690|NCT01111149|E2|Reported Event|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
645691|NCT01111149|E1|Reported Event|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
645692|NCT01111162|B1|Baseline|Vaccination Group (Single Arm Study)|All participants
645693|NCT01111162|P1|Participant Flow|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
645694|NCT01111162|O1|Outcome|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
645695|NCT01111162|O1|Outcome|Vacinees|
645696|NCT01111162|E1|Reported Event|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
645697|NCT01111240|B1|Baseline|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645698|NCT01111240|P1|Participant Flow|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645699|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645700|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645701|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645704|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645705|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645706|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645707|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645708|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645709|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645710|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645711|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645712|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645713|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645714|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645715|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645899|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
645717|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645718|NCT01111240|E1|Reported Event|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
645719|NCT01111292|B3|Baseline|Total|Total of all reporting groups
645720|NCT01111292|B2|Baseline|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
645721|NCT01111292|B1|Baseline|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.
Inositol: Given PO
Laboratory Biomarker Analysis: Correlative studies"
645722|NCT01111292|P2|Participant Flow|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
645723|NCT01111292|P1|Participant Flow|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.
Inositol: Given PO
Laboratory Biomarker Analysis: Correlative studies"
645724|NCT01111292|O2|Outcome|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
645725|NCT01111292|O1|Outcome|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.
Inositol: Given PO
Laboratory Biomarker Analysis: Correlative studies"
645726|NCT01111292|E2|Reported Event|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.
Placebo: Given PO
Laboratory Biomarker Analysis: Correlative studies"
645727|NCT01111292|E1|Reported Event|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.
Inositol: Given PO
Laboratory Biomarker Analysis: Correlative studies"
645728|NCT01111305|B3|Baseline|Total|Total of all reporting groups
645729|NCT01111305|B2|Baseline|Placebo|"Placebo
Diethylcarbamazine"
645730|NCT01111305|B1|Baseline|Reslizumab|"Reslizumab
Diethylcarbamazine"
645731|NCT01111305|P2|Participant Flow|Placebo|"Placebo
Diethylcarbamazine"
645732|NCT01111305|P1|Participant Flow|Reslizumab|"Reslizumab
Diethylcarbamazine"
645733|NCT01111305|O2|Outcome|Placebo|"Placebo
Diethylcarbamazine"
645734|NCT01111305|O1|Outcome|Reslizumab|"Reslizumab
Diethylcarbamazine"
645735|NCT01111305|O2|Outcome|Placebo + DEC|"Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days
Diethylcarbamazine
Placebo"
645736|NCT01111305|O1|Outcome|Reslizumab + DEC|"Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days
Reslizumab
Diethylcarbamazine"
645737|NCT01111305|O2|Outcome|Placebo + DEC|"Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days
Diethylcarbamazine
Placebo"
645738|NCT01111305|O1|Outcome|Reslizumab + DEC|"Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days
Reslizumab
Diethylcarbamazine"
645739|NCT01111305|E2|Reported Event|Placebo + DEC|"Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days
Diethylcarbamazine
Placebo"
645740|NCT01111305|E1|Reported Event|Reslizumab + DEC|"Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days
Reslizumab
Diethylcarbamazine"
645741|NCT01111318|B5|Baseline|Total|Total of all reporting groups
645742|NCT01111318|B4|Baseline|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645743|NCT01111318|B3|Baseline|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645841|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645744|NCT01111318|B2|Baseline|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645745|NCT01111318|B1|Baseline|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645746|NCT01111318|P4|Participant Flow|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645747|NCT01111318|P3|Participant Flow|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645748|NCT01111318|P2|Participant Flow|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645749|NCT01111318|P1|Participant Flow|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645750|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645751|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645752|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645753|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645754|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645755|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645756|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645757|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645758|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645759|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645760|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645761|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645762|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645763|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645764|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645765|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645766|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645767|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645768|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645769|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645770|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645771|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645772|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645773|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645774|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645775|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645776|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645777|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645778|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645779|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645780|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645781|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645782|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645783|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645784|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645785|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645786|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645787|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
656507|NCT01146457|E2|Reported Event|Morphine 25|Morphine: Active dosage
645788|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645789|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645790|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645791|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645792|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645793|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645794|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645795|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645796|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645797|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645798|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645799|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645800|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645801|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645802|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645803|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645804|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645805|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645806|NCT01111318|E4|Reported Event|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
645842|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645807|NCT01111318|E3|Reported Event|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
645808|NCT01111318|E2|Reported Event|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
645809|NCT01111318|E1|Reported Event|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
645810|NCT01111331|B1|Baseline|Study Overall|"Total number of patients randomised and treated in the study. This was a randomised, cross-over, open-label trial consisting of three treatments. 18 patients were randomised to one of two possible treatment sequences. The three treatments were
Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1"
645811|NCT01111331|P2|Participant Flow|Warfarin / Empa / Empa Plus Warfarin|"Patients received three treatments in the following order
Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
There was a washout period of at least 14 days between the first and second treatment periods."
645812|NCT01111331|P1|Participant Flow|Empa / Empa Plus Warfarin / Warfarin|"Patients received three treatments in the following order
Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
There was a washout period of at least 14 days between the second and third treatment periods."
645813|NCT01111331|O3|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645814|NCT01111331|O2|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645815|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
645900|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
645816|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645817|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645818|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645819|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645820|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645821|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645822|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645823|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645824|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645825|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645826|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645827|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645828|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645829|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645830|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645831|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645832|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645833|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645834|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645835|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645836|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645837|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645838|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645839|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645840|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645843|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645844|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645845|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645846|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645847|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645848|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645849|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645850|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645851|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645852|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645853|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645854|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645855|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645856|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645857|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
656508|NCT01146457|E1|Reported Event|Placebo|Saline: Saline Control
645858|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645859|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645860|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645861|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
645862|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645863|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
645864|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645865|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
645866|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645867|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
645868|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645869|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
645870|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645871|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
645872|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645873|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
645874|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645875|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645876|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645877|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645878|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645879|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645880|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645881|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645882|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645883|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
645884|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645885|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
645886|NCT01111331|E3|Reported Event|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
645887|NCT01111331|E2|Reported Event|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
645888|NCT01111331|E1|Reported Event|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
645889|NCT01111370|B1|Baseline|Continuous Glucose Monitoring System|The Dexcom G4 Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons with diabetes. The system is intended for single patient use and requires a prescription.
645890|NCT01111370|P1|Participant Flow|Continuous Glucose Monitoring System|DexCom™ G4 Continuous Glucose Monitoring System : Continuous Glucose Monitoring System, that is a glucose monitoring device indicated for detecting trends and tracking patterns in persons with diabetes. The system is intended for single patient use and requires a prescription.
645891|NCT01111370|O1|Outcome|CGM Device|DexCom™ G4 Continuous Glucose Monitoring System
645892|NCT01111370|E1|Reported Event|Real Time Continuous Glucose Monitoring System|"continuous glucose monitoring system
DexCom™ G4 Continuous Glucose Monitoring System: Continuous Glucose Monitoring System"
645893|NCT01111461|B1|Baseline|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
645894|NCT01111461|P1|Participant Flow|Lenvatinib 24 mg|Lenvatinib hard capsules, 24 mg (two 10-mg capsules and one 4-mg capsule) were self-administered orally once a day in the morning (without regard to food intake) in 28-day cycles. Dose reduction or interruption was allowed for participants who experienced lenvatinib-related toxicity.
645895|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
645896|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
645897|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
646604|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
645903|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
645904|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
645905|NCT01111461|E1|Reported Event|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
645906|NCT01111526|B1|Baseline|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
645907|NCT01111526|P3|Participant Flow|Phase II Participants Treated at MTD|All participants enrolled during Phase II.
645908|NCT01111526|P2|Participant Flow|Phase I Participants Evaluable for MTD|Participants treated after the formulation change.
645909|NCT01111526|P1|Participant Flow|Phase I Participants Not Evaluable for MTD|Participants who began treatment before the formulation change.
645910|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
645911|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
645912|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
645913|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
645914|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
645915|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
645916|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
645917|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
645918|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
645919|NCT01111526|E1|Reported Event|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
645920|NCT01117090|B1|Baseline|Intrathecal Pump Patients|Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
645921|NCT01117090|P1|Participant Flow|Intrathecal Pump Patients|Subjects previously implanted with an intrathecal pump who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
645922|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data in response to valsalva were analyzable and who received a diagnosis of catheter complication from the physician
645923|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data in response to valsalva were analyzable and who received a diagnosis of normal catheter function from the physician
645924|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data in response to cough were analyzable and who received a diagnosis of catheter complication from the physician
645972|NCT01117337|E2|Reported Event|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
645925|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data in response to cough were analyzable and who received a diagnosis of normal catheter function from the physician
645926|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose catheter flow resistance check data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
645927|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose catheter flow resistance check data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician
645928|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
645929|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician
645930|NCT01117090|E1|Reported Event|Intrathecal Pump Patients|Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
645931|NCT01117181|B3|Baseline|Total|Total of all reporting groups
645932|NCT01117181|B2|Baseline|Placebo|matching placebo and psychosocial intervention
645933|NCT01117181|B1|Baseline|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
645934|NCT01117181|P2|Participant Flow|Placebo|matching placebo and psychosocial intervention
645935|NCT01117181|P1|Participant Flow|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
645936|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
645937|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
645938|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
645939|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
645940|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
656509|NCT01146600|B3|Baseline|Total|Total of all reporting groups
645941|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
645942|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
645943|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
645944|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
645945|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
645946|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
645947|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
645948|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
645949|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
645950|NCT01117181|E2|Reported Event|Placebo|matching placebo and psychosocial intervention
645951|NCT01117181|E1|Reported Event|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
645952|NCT01117311|B1|Baseline|Entire Study Population|Includes groups randomized to have the VNB off first and the VNB on first.
645953|NCT01117311|P2|Participant Flow|VNB on First, Then VNB Off|Subjects assigned to this reporting group had the vagal nerve blocker (VNB) on first for the first intervention (Mixed Meal 2), then VNB off for the second intervention (Mixed Meal 3).
645954|NCT01117311|P1|Participant Flow|VNB Off First, Then VNB on|Subjects assigned to this reporting group had the vagal nerve blocker (VNB) off first for the first intervention (Mixed Meal 2), then VNB on for the second intervention (Mixed Meal 3).
645955|NCT01117311|O2|Outcome|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
645956|NCT01117311|O1|Outcome|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
645957|NCT01117311|O2|Outcome|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
645958|NCT01117311|O1|Outcome|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
645959|NCT01117311|E2|Reported Event|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
645960|NCT01117311|E1|Reported Event|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
645961|NCT01117337|B3|Baseline|Total|Total of all reporting groups
645962|NCT01117337|B2|Baseline|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
645963|NCT01117337|B1|Baseline|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
645964|NCT01117337|P2|Participant Flow|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
645965|NCT01117337|P1|Participant Flow|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
645966|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
645967|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
645968|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
645969|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
645970|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
645971|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
646576|NCT01119937|O1|Outcome|NVA237|50µg once daily
645973|NCT01117337|E1|Reported Event|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
645974|NCT01117350|B3|Baseline|Total|Total of all reporting groups
645975|NCT01117350|B2|Baseline|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
645976|NCT01117350|B1|Baseline|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
645977|NCT01117350|P2|Participant Flow|Liraglutide (Comparative Period)/ Insulin Glargine (Extension)|"Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)
For patients included in the extension period: Insulin Glargine (dosing same as above)"
645978|NCT01117350|P1|Participant Flow|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
645979|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
645980|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
645981|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
645982|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
645983|NCT01117350|O1|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
645984|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
646605|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
645985|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
645986|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
645987|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
645988|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
645989|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
645990|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
645991|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
645992|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
645993|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
645994|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
645995|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
645996|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
645997|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
645998|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
645999|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
646000|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
646001|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
646002|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
646003|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
646119|NCT01118728|O1|Outcome|Sarilumab|Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
646004|NCT01117350|E3|Reported Event|Extension Period: Insulin Glargine|"Following a treatment with liraglutide during the comparative period, those patients have received insulin glargine during the extension period.
Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days"
646005|NCT01117350|E2|Reported Event|Comparative Period: Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)
646006|NCT01117350|E1|Reported Event|Comparative Period: Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
646007|NCT01118325|B4|Baseline|Total|Total of all reporting groups
646008|NCT01118325|B3|Baseline|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
646009|NCT01118325|B2|Baseline|AZD6140 90 mg bd|AZD6140 90 mg twice daily
646010|NCT01118325|B1|Baseline|AZD6140 45 mg bd|AZD6140 45 mg twice daily
646011|NCT01118325|P3|Participant Flow|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
646012|NCT01118325|P2|Participant Flow|AZD6140 90 mg bd|AZD6140 90 mg twice daily
646013|NCT01118325|P1|Participant Flow|AZD6140 45 mg bd|AZD6140 45 mg twice daily
646014|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
646015|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese Patients
646016|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
646017|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese Patients
646018|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
646019|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
646020|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
646021|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
646022|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Jpanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
646023|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
646024|NCT01118325|O2|Outcome|AZD6140 45mg bd in Non-Jpanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
646025|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
646026|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
646027|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
646028|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
646029|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
646030|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
646031|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
646032|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
646033|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
646034|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
646035|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
646036|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
646037|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
646038|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
646039|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
646040|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily
646041|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
646042|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
646043|NCT01118325|O1|Outcome|Arm 1 - AZD6140 45 mg bd|AZD6140 45 mg twice daily
646044|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
646045|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
646046|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily
646047|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
646048|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily in Japanese patients
646049|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily in Japanese patients
646050|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
646051|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily in Japanese patients
646052|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily in Japanese patients
646053|NCT01118325|E3|Reported Event|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
646054|NCT01118325|E2|Reported Event|AZD6140 90 mg bd|AZD6140 90 mg twice daily
646055|NCT01118325|E1|Reported Event|AZD6140 45 mg bd|AZD6140 45 mg twice daily
646056|NCT01118377|B1|Baseline|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
646057|NCT01118377|P1|Participant Flow|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
646577|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
646058|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
646059|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
646060|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
646061|NCT01118377|E1|Reported Event|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
646062|NCT01118455|B3|Baseline|Total|Total of all reporting groups
646063|NCT01118455|B2|Baseline|Anti-Epileptic Drug (AED) - ITT Population|"This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.
The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED."
646064|NCT01118455|B1|Baseline|Vagus Nerve Stimulation (VNS) Therapy - ITT Population|"Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.
The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED."
646065|NCT01118455|P2|Participant Flow|Anti-Epileptic Drug (AED) - ITT Population|Anti-epileptic drug therapy
646066|NCT01118455|P1|Participant Flow|Vagus Nerve Stimulation (VNS) - ITT Population|Vagus Nerve Stimulation (VNS) Therapy
646067|NCT01118455|O2|Outcome|Anti-Epileptic Drug (AED)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to AED Group.
646068|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to VNS Therapy.
646069|NCT01118455|O2|Outcome|Anti-Epileptic Drug (AED)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to AED Group.
646070|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to VNS Therapy.
646071|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
646072|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
646073|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
646074|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
646075|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
646076|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
646077|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
646078|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
646079|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
646080|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
646081|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
646082|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
646083|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
646084|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
646085|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
646086|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
646087|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
646088|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
646089|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
646090|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
646390|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
646091|NCT01118455|E2|Reported Event|Anti-Epileptic Drug (AED) - Safety Population|"This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.
All subjects were considered evaluable for tolerability and safety after initiation of adjunctive AED treatment."
646092|NCT01118455|E1|Reported Event|Vagus Nerve Stimulation (VNS) Therapy - Safety Population|"Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.
All subjects were considered evaluable for tolerability and safety after implantation of the VNS Therapy System.
NOTE: Number of participants analyzed in VNS safety population includes one patient explanted that did not receive stimulation and was therefore excluded from ITT population."
646093|NCT01118624|B1|Baseline|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
646094|NCT01118624|P1|Participant Flow|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
646095|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
646096|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
646097|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
646098|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
646099|NCT01118624|E1|Reported Event|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
646100|NCT01118663|B3|Baseline|Total|Total of all reporting groups
646101|NCT01118663|B2|Baseline|Acetadote|"Acetadote [Old formulation containing EDTA]
Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
646102|NCT01118663|B1|Baseline|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
646103|NCT01118663|P2|Participant Flow|Acetadote|"Acetadote [Old formulation containing EDTA]
Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
646104|NCT01118663|P1|Participant Flow|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
646105|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]
Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
646106|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
646107|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]
Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
646108|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
646109|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]
Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
646110|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
646111|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]
Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
646112|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
646113|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]
Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
646114|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
646115|NCT01118663|E2|Reported Event|Acetadote|"Acetadote [Old formulation containing EDTA]
Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
646116|NCT01118663|E1|Reported Event|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
646117|NCT01118728|B1|Baseline|Sarilumab|Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
646118|NCT01118728|P1|Participant Flow|Sarilumab|Sarilumab 150 mg subcutaneous (SC) injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
646578|NCT01119937|O1|Outcome|NVA237|50µg once daily
646120|NCT01118728|O1|Outcome|Sarilumab|Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
646121|NCT01118728|E1|Reported Event|Sarilumab|Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
646122|NCT01118741|B3|Baseline|Total|Total of all reporting groups
646123|NCT01118741|B2|Baseline|Disulfiram High Dose 500mg Dose|After 9 subjects were enrolled in the low dose arm, the high dose was opened.
646124|NCT01118741|B1|Baseline|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
646125|NCT01118741|P2|Participant Flow|Disulfiram High Dose 500mg Dose|After accrual to the low dose was complete,ten subjects were assigned to the high dose (500mg) arm. These subjects took 500mg daily for 28 days per cycle.
646126|NCT01118741|P1|Participant Flow|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose (250mg) arm. These subjects took 250mg daily for 28 days per cycle.
646127|NCT01118741|O2|Outcome|Disulfiram High Dose 500mg Dose|
646128|NCT01118741|O1|Outcome|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
646129|NCT01118741|E2|Reported Event|Disulfiram High Dose 500mg Dose|After 9 subjects were enrolled in the low dose arm, the high dose was opened.
646130|NCT01118741|E1|Reported Event|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
646131|NCT01118780|B3|Baseline|Total|Total of all reporting groups
646132|NCT01118780|B2|Baseline|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646144|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646169|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646275|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
646276|NCT01119118|E1|Reported Event|ZD4054|ZD4054 + multimodal PET/MRI imaging
646133|NCT01118780|B1|Baseline|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646134|NCT01118780|P2|Participant Flow|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646135|NCT01118780|P1|Participant Flow|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646136|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646137|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646138|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646186|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646139|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646140|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646141|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646142|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646143|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646145|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646146|NCT01118780|O3|Outcome|Placebo|Participants, whose final dose during the treatment period was either placebo or duloxetine 30 mg, were administered a placebo capsule orally, once daily for 2 weeks, during the 2-week taper period.
646147|NCT01118780|O2|Outcome|Duloxetine 60 mg Then 30 mg|Participants, whose final dose during the treatment period was 90 mg or 120 mg duloxetine, were administered duloxetine 60 mg (two 30-mg duloxetine capsules) orally, once daily for 1 week followed by a 30-mg duloxetine capsule orally, once daily for 1 week, during the 2-week taper period.
646148|NCT01118780|O1|Outcome|Duloxetine 30 mg Then Placebo|Participants, whose final dose during the treatment period was duloxetine 60 mg, were administered a 30-mg duloxetine capsule orally, once daily for 1 week followed by a placebo capsule orally, once daily for 1 week, during the 2-week taper period.
646149|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646150|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646151|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646220|NCT01118975|O1|Outcome|Pilot Phase|The pilot phase consisted of an escalating dose design. Three patients received lapatinib 1,250 mg daily plus 300 mg vorinistat 4 days on then 3 days off. This dose was tolerated so six more patients recieved lapatinib 1,250 mg daily plus 400 mg vorinistat 4 days on 3 days off.
646152|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646153|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646154|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646155|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646156|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646157|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646277|NCT01119131|B4|Baseline|Total|Total of all reporting groups
646158|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646159|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646160|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646161|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646187|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646221|NCT01118975|E2|Reported Event|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
646222|NCT01118975|E1|Reported Event|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
646162|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646163|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646164|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646165|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646166|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646167|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646168|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646170|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646171|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646172|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646173|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646174|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646175|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646176|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646177|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646178|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646179|NCT01118780|E2|Reported Event|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
646180|NCT01118780|E1|Reported Event|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).
Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
646181|NCT01118845|B1|Baseline|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646182|NCT01118845|P1|Participant Flow|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646183|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646184|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646185|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646217|NCT01118975|P2|Participant Flow|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
646223|NCT01118988|B4|Baseline|Total|Total of all reporting groups
646188|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646189|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646190|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646191|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646192|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646193|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646194|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646195|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646196|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646197|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646198|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646199|NCT01118845|E1|Reported Event|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
646200|NCT01118949|B1|Baseline|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
646201|NCT01118949|P1|Participant Flow|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
646218|NCT01118975|P1|Participant Flow|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
646219|NCT01118975|O1|Outcome|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days off
646202|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
646203|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
646204|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
646205|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
646206|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
646207|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
646230|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646599|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646208|NCT01118949|E1|Reported Event|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
646209|NCT01118962|B1|Baseline|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
646210|NCT01118962|P1|Participant Flow|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
646211|NCT01118962|O1|Outcome|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
646212|NCT01118962|O1|Outcome|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
646213|NCT01118962|E1|Reported Event|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
646214|NCT01118975|B3|Baseline|Total|Total of all reporting groups
646215|NCT01118975|B2|Baseline|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
646216|NCT01118975|B1|Baseline|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
646224|NCT01118988|B3|Baseline|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
646225|NCT01118988|B2|Baseline|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646226|NCT01118988|B1|Baseline|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646227|NCT01118988|P3|Participant Flow|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
646228|NCT01118988|P2|Participant Flow|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646229|NCT01118988|P1|Participant Flow|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646600|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646231|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646232|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646233|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646234|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646235|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646236|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646237|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646238|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646239|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646240|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646296|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.
calcium: 1000mg calcium daily
Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
646241|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646242|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646243|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646244|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646245|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646246|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646247|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646248|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646273|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
646274|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
646249|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646250|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646251|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646252|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646253|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646254|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646255|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646256|NCT01118988|E3|Reported Event|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
646257|NCT01118988|E2|Reported Event|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
646579|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
646258|NCT01118988|E1|Reported Event|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention
Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
646259|NCT01119001|B1|Baseline|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
646260|NCT01119001|P1|Participant Flow|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
646261|NCT01119001|O3|Outcome|Assistive Technology Enironment|Accuracy typing for three sessions with the BCI acting as a keyboard for a Dynawrite communication system.
646262|NCT01119001|O2|Outcome|Computer Environment|Accuracy typing for three sessions with the BCI acting as a keyboard for a laptop computer.
646263|NCT01119001|O1|Outcome|Brain-computer Interface (BCI) Environment|Accuracy typing for three sessions with the BCI acting as a stand-alone device.
646264|NCT01119001|E1|Reported Event|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
646265|NCT01119040|B1|Baseline|Peg Rescue|Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes.
646266|NCT01119040|P1|Participant Flow|"NOTES PEG Rescue"|Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions.
646267|NCT01119040|O1|Outcome|NOTES PEG Rescue|Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions.
646268|NCT01119040|E1|Reported Event|NOTES PEG Rescue|Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes.
646269|NCT01119118|B1|Baseline|ZD4054|ZD4054 + multimodal PET/MRI imaging
646270|NCT01119118|P1|Participant Flow|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
646271|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
646272|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
646278|NCT01119131|B3|Baseline|Placebo|"Will be on placebo and 1000mg of calcium.
calcium: 1000mg calcium daily
Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
646279|NCT01119131|B2|Baseline|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646280|NCT01119131|B1|Baseline|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646281|NCT01119131|P3|Participant Flow|Placebo|"Will be on placebo and 1000mg of calcium.
calcium: 1000mg calcium daily
Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
646282|NCT01119131|P2|Participant Flow|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646283|NCT01119131|P1|Participant Flow|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646284|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.
calcium: 1000mg calcium daily
Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
646285|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646286|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646287|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.
calcium: 1000mg calcium daily
Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
646288|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646289|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646290|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.
calcium: 1000mg calcium daily
Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
646291|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646292|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646293|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.
calcium: 1000mg calcium daily
Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
646294|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646295|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646297|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646298|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646299|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.
calcium: 1000mg calcium daily
Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
646300|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646301|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646302|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.
calcium: 1000mg calcium daily
Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
646303|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646304|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646305|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.
calcium: 1000mg calcium daily
Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
646306|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646307|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646308|NCT01119131|E3|Reported Event|Placebo|"Will be on placebo and 1000mg of calcium.
calcium: 1000mg calcium daily
Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
646309|NCT01119131|E2|Reported Event|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646310|NCT01119131|E1|Reported Event|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily"
646311|NCT01119222|B1|Baseline|Entire Study Population|Includes all participants who initiated in any treatment sequence
646312|NCT01119222|P4|Participant Flow|Diphenhydramine, Placebo, Gabapentin, Morphine|Diphenhydramine 50 mg tablet first, then placebo (capsules, tablet and intravenous (IV), then gabapentin 1200 mg capsule, then morphine 10 mg IV.
646313|NCT01119222|P3|Participant Flow|Gabapentin, Diphenhydramine, Morphine, Placebo|Gabapentin 1200 mg capsule first, then diphenhydramine 50 mg tablet, then morphine 10 mg intravenous (IV), then placebo (capsules, tablet and IV).
646314|NCT01119222|P2|Participant Flow|Morphine, Gabapentin, Placebo, Diphenhydramine|Morphine 10 mg intravenous (IV) first, then gabapentin 1200 mg capsule, placebo (capsules, tablet and IV), then diphenhydramine 50 mg tablet.
646315|NCT01119222|P1|Participant Flow|Placebo, Morphine, Diphenhydramine, Gabapentin|Placebo (capsules, tablet and intravenous (IV) first, then morphine 10 mg IV, then diphenhydramine 50 mg tablet, then gabapentin 1200 mg capsule.
646316|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
646317|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
646318|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
646319|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
646320|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
646321|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
646322|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
646323|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
646324|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
646325|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
646326|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
646327|NCT01119222|O1|Outcome|Gabapentin|Gabapentin 1200 mg
646328|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
646329|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
646330|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
646331|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
646332|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
646333|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
646334|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
646335|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
646336|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
646337|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
646338|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
646339|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
646340|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
646341|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
646342|NCT01119222|O2|Outcome|Morphine|Morphine 10 mg
646343|NCT01119222|O1|Outcome|Gabpentin|Gabapentin 1200 mg
646344|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
646345|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
646346|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
646347|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
646348|NCT01119222|E4|Reported Event|Placebo|Oral and IV doses to match active treatments
646349|NCT01119222|E3|Reported Event|Diphenhydramine|Diphenhydramine single oral 50 mg dose
646353|NCT01119287|B6|Baseline|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646354|NCT01119287|B5|Baseline|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646355|NCT01119287|B4|Baseline|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646356|NCT01119287|B3|Baseline|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646357|NCT01119287|B2|Baseline|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646358|NCT01119287|B1|Baseline|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646359|NCT01119287|P6|Participant Flow|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646360|NCT01119287|P5|Participant Flow|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646361|NCT01119287|P4|Participant Flow|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646362|NCT01119287|P3|Participant Flow|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646363|NCT01119287|P2|Participant Flow|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646364|NCT01119287|P1|Participant Flow|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646365|NCT01119287|O4|Outcome|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646366|NCT01119287|O3|Outcome|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646367|NCT01119287|O2|Outcome|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646368|NCT01119287|O1|Outcome|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646369|NCT01119287|O4|Outcome|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646370|NCT01119287|O3|Outcome|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646371|NCT01119287|O2|Outcome|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646372|NCT01119287|O1|Outcome|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646373|NCT01119287|E3|Reported Event|Tears Naturale II|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646374|NCT01119287|E2|Reported Event|Patanol|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646375|NCT01119287|E1|Reported Event|Maxidex|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
646376|NCT01119443|B3|Baseline|Total|Total of all reporting groups
646377|NCT01119443|B2|Baseline|Treatment Sequence B|0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
646378|NCT01119443|B1|Baseline|Treatment Sequence A|1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
646379|NCT01119443|P2|Participant Flow|Treatment Sequence B|0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
646380|NCT01119443|P1|Participant Flow|Treatment Sequence A|1.5 mg x 1 tablet once daily (q.d.) fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
646381|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
646382|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
646383|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
646384|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
646385|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
646386|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
646387|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
646388|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
646389|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
646391|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
646392|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
646393|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
646394|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
646395|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
646396|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
646397|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
646398|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
646399|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
646400|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
646401|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
646402|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
646403|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
646404|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
646405|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
646406|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
646407|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
646408|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
646409|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
646410|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
646411|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
646412|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
646413|NCT01119443|E3|Reported Event|1.5 mg q.d. Fast|1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fast condition (10 days in crossover)
646414|NCT01119443|E2|Reported Event|1.5 mg q.d. Fed|1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fed condition (10days in crossover)
646415|NCT01119443|E1|Reported Event|Up-titration|Up-titration to 0.75mg (10 days)
646416|NCT01119625|B3|Baseline|Total|Total of all reporting groups
646417|NCT01119625|B2|Baseline|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646418|NCT01119625|B1|Baseline|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646419|NCT01119625|P2|Participant Flow|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646420|NCT01119625|P1|Participant Flow|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646421|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646469|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
646470|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
646471|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
646472|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older.
646422|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646423|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646424|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646425|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646426|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646427|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646428|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646429|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646430|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646431|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646432|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646433|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646434|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646435|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646436|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646437|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646438|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646439|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646440|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646441|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646442|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646443|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646444|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646445|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646446|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646447|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646448|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646449|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646450|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646451|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646452|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646453|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646454|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646455|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646456|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646457|NCT01119625|E2|Reported Event|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646458|NCT01119625|E1|Reported Event|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
646459|NCT01119703|B3|Baseline|Total|Total of all reporting groups
646460|NCT01119703|B2|Baseline|Elderly Participants|Aged 65 years and older
646461|NCT01119703|B1|Baseline|Younger Participants|Aged 25 to 40 years old
646462|NCT01119703|P2|Participant Flow|Elderly Participants|Participants 65 years old and older.
646463|NCT01119703|P1|Participant Flow|Younger Participants|Participants 25 to 40 years of age.
646464|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
646465|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
646466|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
646467|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
646468|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
646569|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
646473|NCT01119703|E1|Reported Event|All Participants|Participants who received at least one dose of each vaccine
646474|NCT01119716|B1|Baseline|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646475|NCT01119716|P1|Participant Flow|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646476|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646477|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646478|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646479|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646480|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed
646481|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed
646482|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646483|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646484|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646485|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646486|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646487|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646601|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646488|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646489|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646490|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646491|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646492|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646493|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646494|NCT01119716|E1|Reported Event|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
646495|NCT01119755|B1|Baseline|Group 1|
646496|NCT01119755|P1|Participant Flow|Group 1|
646497|NCT01119755|O1|Outcome|Group 1|
646498|NCT01119755|O1|Outcome|Group 1|
646499|NCT01119755|O1|Outcome|Group 1|
646500|NCT01119755|O1|Outcome|Group 1|
646501|NCT01119755|O1|Outcome|Group 1|
646502|NCT01119755|O1|Outcome|Group 1|
646503|NCT01119755|O1|Outcome|Group 1|
646504|NCT01119755|O1|Outcome|Group 1|
646505|NCT01119755|E1|Reported Event|Group 1|
646506|NCT01119768|B3|Baseline|Total|Total of all reporting groups
646507|NCT01119768|B2|Baseline|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646508|NCT01119768|B1|Baseline|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646509|NCT01119768|P2|Participant Flow|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646510|NCT01119768|P1|Participant Flow|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646511|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646512|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646513|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646514|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646515|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646516|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646517|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646518|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646519|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646520|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646521|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646522|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646523|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646524|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646525|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646526|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646527|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646528|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646529|NCT01119768|E2|Reported Event|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
646530|NCT01119768|E1|Reported Event|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
646531|NCT01119794|B1|Baseline|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,
Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
646532|NCT01119794|P1|Participant Flow|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,
Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
646533|NCT01119794|O1|Outcome|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,
Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
646534|NCT01119794|E1|Reported Event|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,
Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
646535|NCT01119859|B3|Baseline|Total|Total of all reporting groups
646536|NCT01119859|B2|Baseline|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
646537|NCT01119859|B1|Baseline|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
646538|NCT01119859|P2|Participant Flow|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
646602|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646539|NCT01119859|P1|Participant Flow|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
646540|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
646541|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
646542|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
646543|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
646544|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
646545|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
646546|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
646547|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
646548|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
646549|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
646550|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
646551|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
646552|NCT01119859|E2|Reported Event|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
646553|NCT01119859|E1|Reported Event|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
646554|NCT01119937|B3|Baseline|Total|Total of all reporting groups
646555|NCT01119937|B2|Baseline|Tiotropium|18µg once daily
646556|NCT01119937|B1|Baseline|NVA237|50µg once daily
646557|NCT01119937|P2|Participant Flow|Tiotropium|18µg once daily
646558|NCT01119937|P1|Participant Flow|NVA237|50µg once daily
646559|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
646560|NCT01119937|O1|Outcome|NVA237|50µg once daily
646561|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
646562|NCT01119937|O1|Outcome|NVA237|50µg once daily
646563|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
646564|NCT01119937|O1|Outcome|NVA237|50µg once daily
646565|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
646566|NCT01119937|O1|Outcome|NVA237|50µg once daily
646567|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
646568|NCT01119937|O1|Outcome|NVA237|50µg once daily
646580|NCT01119937|O1|Outcome|NVA237|50µg once daily
646581|NCT01119937|E2|Reported Event|Tiotropium|18µg once daily
646582|NCT01119937|E1|Reported Event|NVA237|50µg once daily
646583|NCT01119950|B1|Baseline|All Participants|All participants in the safety set
646584|NCT01119950|P1|Participant Flow|Overall Study|"For the overall study, 388 participants were randomized and 1 non-randomized participant received drug in error and was discontinued. This participant was excluded from randomized number of patients but included in number of treated participants and in the safety set.
Out of the 388 participants randomized, 341 completed study treatment and 47 discontinued, including 3 misrandomized participants who did not receive any study medication."
646585|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646586|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646587|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646588|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646589|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646590|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646591|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646592|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646593|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646594|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646595|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646596|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646597|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646598|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646606|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646607|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646608|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646609|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646610|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646611|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646612|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646613|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646614|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646615|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646616|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646617|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646618|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646619|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646620|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646621|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646622|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646623|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646624|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646625|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646626|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646627|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646628|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646629|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646630|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646631|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646632|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646633|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646634|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646635|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646636|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646637|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646638|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646639|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646640|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646641|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646642|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646643|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646644|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646645|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646646|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646647|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646648|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646649|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646650|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646651|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646652|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646653|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646654|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646655|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646656|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646657|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646658|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646659|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646660|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646661|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646662|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646663|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646664|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646665|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646666|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646667|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646668|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646669|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646670|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646671|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646672|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646673|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646674|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646675|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646676|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646677|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646678|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646679|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646680|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646681|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646682|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646683|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646684|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646685|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646686|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646687|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646688|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646689|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646690|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646691|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646692|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646693|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646694|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646695|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646696|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646697|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646698|NCT01119950|O7|Outcome|NVA237 50 ug b.i.d.|NVA237 50 ug twice daily
646699|NCT01119950|O6|Outcome|NVA237 100 ug q.d.|NVA237 100 ug once daily
646700|NCT01119950|O5|Outcome|NVA237 25 ug b.i.d.|NVA237 25 ug twice daily
646701|NCT01119950|O4|Outcome|NVA237 50 ug q.d.|NVA237 50 ug once daily
646702|NCT01119950|O3|Outcome|NVA237 12.5 ug b.i.d.|NVA237 12.5 ug twice daily
646703|NCT01119950|O2|Outcome|NVA237 25 ug q.d.|NVA237 12.5 ug once daily
646704|NCT01119950|O1|Outcome|NVA237 12.5 ug q.d.|NVA237 25 ug once daily
646705|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646706|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646707|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646708|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646709|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646710|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646711|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646712|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
646713|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646714|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646715|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646716|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646717|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646718|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646719|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646720|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646721|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646722|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646723|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646724|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646725|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646726|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646727|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646728|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646729|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646730|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646731|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646732|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646733|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646734|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646735|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
649548|NCT01127659|P5|Participant Flow|Eugonadal Diabetes|no intervention
646736|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646737|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646738|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646739|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646740|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646741|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646742|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646743|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646744|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646745|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646746|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646747|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646748|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646749|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646750|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646751|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646752|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646753|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646754|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646755|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646756|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646757|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646758|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646759|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646760|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646761|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646762|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646763|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646764|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646765|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646766|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646767|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646768|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646769|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646770|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646771|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646772|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646773|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646774|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646775|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646776|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646777|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646778|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646779|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646780|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646781|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646782|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646783|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646784|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646785|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646786|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646787|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646788|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646789|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646790|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646791|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646792|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646793|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646794|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646795|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646796|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646797|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646798|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646799|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646800|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646801|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646802|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646803|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646804|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646805|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646806|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646807|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646808|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646809|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646810|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646811|NCT01119950|O1|Outcome|Overall Study|A statistical modeling process was used to achieve the key objective. A set of 4 candidate models based on the Emax dose-response shape was derived plus their sigmoidal Emax counterparts (a total of 8 models) that describe the evolution of dose response over time. A model-averaging process was then employed to obtain response predictions as the weighted average of individual model predictions and confidence limits derived using a simulation-based procedure.
646812|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
646813|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
646814|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
646815|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
646816|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
646817|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
646818|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
646819|NCT01119950|O1|Outcome|Overall Study|A statistical modeling process was used to achieve the key objective. A set of 4 candidate models based on the Emax dose-response shape was derived plus their sigmoidal Emax counterparts (a total of 8 models) that describe the evolution of dose response over time. A model-averaging process was then employed to obtain response predictions as the weighted average of individual model predictions and confidence limits derived using a simulation-based procedure.
646820|NCT01119950|E8|Reported Event|Placebo|Placebo
646821|NCT01119950|E7|Reported Event|NVA237 50 ug b.i.d.|NVA237 50 ug b.i.d.
646822|NCT01119950|E6|Reported Event|NVA237 100 ug q.d.|NVA237 100 ug q.d.
646823|NCT01119950|E5|Reported Event|NVA237 25 ug b.i.d.|NVA237 25 ug b.i.d.
646824|NCT01119950|E4|Reported Event|NVA237 50 ug q.d.|NVA237 50 ug q.d.
646825|NCT01119950|E3|Reported Event|NVA237 12.5 ug b.i.d.|NVA237 12.5 ug b.i.d.
646826|NCT01119950|E2|Reported Event|NVA237 25 ug q.d.|NVA237 25 ug q.d.
646827|NCT01119950|E1|Reported Event|NVA237 12.5 ug q.d.|NVA237 12.5 ug q.d.
646828|NCT01120067|B3|Baseline|Total|Total of all reporting groups
646829|NCT01120067|B2|Baseline|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD
Treatment as Usual: Treatment as Usual."
646830|NCT01120067|B1|Baseline|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain
Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
646831|NCT01120067|P2|Participant Flow|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD
Treatment as Usual: Treatment as Usual."
646832|NCT01120067|P1|Participant Flow|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain
Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
646833|NCT01120067|O2|Outcome|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD
Treatment as Usual: Treatment as Usual."
646834|NCT01120067|O1|Outcome|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain
Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
646835|NCT01120067|E2|Reported Event|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD
Treatment as Usual: Treatment as Usual."
646836|NCT01120067|E1|Reported Event|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain
Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
646837|NCT01120093|B1|Baseline|Overall Study Population|All patients randomized into the crossover study
646838|NCT01120093|P5|Participant Flow|Placebo;Aclidinium100;Formoterol;Aclidinium200;Aclidinium400|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
646839|NCT01120093|P4|Participant Flow|Formoterol;Placebo;Aclidinium400;Aclidinium100;Aclidinium200|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
646869|NCT01120184|B3|Baseline|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646840|NCT01120093|P3|Participant Flow|Aclidinium400;Formoterol;Aclidinium200;Placebo;Aclidinium100|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
646841|NCT01120093|P2|Participant Flow|Aclidinium200;Aclidinium400;Aclidinium100;Formoterol;Placebo|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
646874|NCT01120184|P1|Participant Flow|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646842|NCT01120093|P1|Participant Flow|Aclidinium100;Aclidinium200;Placebo;Aclidinium400;Formoterol|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.
In period 1, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 2, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 3, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 4, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.
In period 5, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days."
646843|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
646844|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
646845|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
646846|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
646847|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
646848|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
646849|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
646850|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
646851|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
646852|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
646853|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
646854|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
646855|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
646856|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
646857|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
646858|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
646859|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
646860|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
646861|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
646862|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
646863|NCT01120093|E5|Reported Event|Placebo|Inhaled placebo dose for 7 days.
646864|NCT01120093|E4|Reported Event|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation by Aerolizer® inhaler at 09:00 (± 30 mins) and 21:00 (± 30 mins) for 7 days.
646865|NCT01120093|E3|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
646866|NCT01120093|E2|Reported Event|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
646867|NCT01120093|E1|Reported Event|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
646868|NCT01120184|B4|Baseline|Total|Total of all reporting groups
647008|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. [We recommend specifying length of time they are followed]"
646870|NCT01120184|B2|Baseline|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646871|NCT01120184|B1|Baseline|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646872|NCT01120184|P3|Participant Flow|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646873|NCT01120184|P2|Participant Flow|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646875|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
648759|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
646876|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646877|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646878|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646879|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646880|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646881|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646882|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646883|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646884|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
647159|NCT01120405|E1|Reported Event|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
646885|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646886|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646887|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646888|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646889|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646890|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646891|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646892|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646893|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646894|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646895|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646896|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646897|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646898|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646899|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646900|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646901|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646902|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646903|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
647018|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
646904|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646905|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646906|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646907|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646908|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646909|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646910|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646911|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646912|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646913|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646914|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646915|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646916|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
647015|NCT01120210|P2|Participant Flow|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
646917|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646918|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646919|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646920|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646921|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646922|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646923|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646924|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646925|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646926|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646927|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646928|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646929|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646930|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
647019|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
646931|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646932|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646933|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646934|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646935|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646936|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646937|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646938|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646939|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646940|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646941|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646942|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646943|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
647020|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
650080|NCT01129102|E3|Reported Event|Placebo|"Placebo for NPC-01
Placebo: Placebo for NPC-01"
646944|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646945|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646946|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646947|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646948|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646949|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646950|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646951|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646952|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646953|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646954|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646955|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646956|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646957|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
647021|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
646958|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646959|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646960|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646961|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646962|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646963|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646964|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646965|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646966|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646967|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646968|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646969|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646970|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
647022|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
650412|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
646971|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646972|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646973|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646974|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646975|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646976|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646977|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646978|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646979|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646980|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646981|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646982|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646983|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646984|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
647023|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
646985|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646986|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646987|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646988|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646989|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646990|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646991|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646992|NCT01120184|E3|Reported Event|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646993|NCT01120184|E2|Reported Event|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
646994|NCT01120184|E1|Reported Event|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
646995|NCT01120197|B3|Baseline|Total|Total of all reporting groups
646996|NCT01120197|B2|Baseline|Control Group|"Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities"
646997|NCT01120197|B1|Baseline|Exercise Group|: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
646998|NCT01120197|P2|Participant Flow|Control Group|"Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities"
647016|NCT01120210|P1|Participant Flow|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
647017|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
646999|NCT01120197|P1|Participant Flow|Exercise Group|"Exercise Group: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
The intervention is in accordance with Rehabilitation treatment guidelines in postmenupausal and senile osteoporosis ( Bonaiuti et al. 2005)."
647000|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
647001|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
647002|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
647003|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
647004|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. [We recommend specifying length of time they are followed]"
647005|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
647006|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
647007|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
647160|NCT01120626|B3|Baseline|Total|Total of all reporting groups
647009|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
647010|NCT01120197|E2|Reported Event|Control Group|"Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
647011|NCT01120197|E1|Reported Event|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
647012|NCT01120210|B3|Baseline|Total|Total of all reporting groups
647013|NCT01120210|B2|Baseline|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
647014|NCT01120210|B1|Baseline|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
647024|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
647025|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
647026|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
647027|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
647028|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
647029|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
647030|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
647031|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
647032|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
647033|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
647034|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
647035|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
647036|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
647037|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
647038|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
647039|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
647040|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
647305|NCT01120717|B3|Baseline|Total|Total of all reporting groups
647041|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
647042|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
647043|NCT01120210|E2|Reported Event|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
647044|NCT01120210|E1|Reported Event|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
647045|NCT01120223|B1|Baseline|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647046|NCT01120223|P1|Participant Flow|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647047|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647048|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647049|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647050|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647051|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647052|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647053|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647054|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647055|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647056|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647057|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647058|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647059|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647060|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647061|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647062|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647063|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647064|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647065|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647442|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
647066|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647067|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647068|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647069|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647070|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647071|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647072|NCT01120223|E1|Reported Event|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
647073|NCT01120236|B3|Baseline|Total|Total of all reporting groups
647074|NCT01120236|B2|Baseline|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given IM
Pharmacological Study: Correlative studies"
647122|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647075|NCT01120236|B1|Baseline|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Bicalutamide: Given PO
Cixutumumab: Given IV
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given IM
Pharmacological Study: Correlative studies"
647076|NCT01120236|P2|Participant Flow|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given IM
Pharmacological Study: Correlative studies"
647077|NCT01120236|P1|Participant Flow|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Bicalutamide: Given PO
Cixutumumab: Given IV
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given IM
Pharmacological Study: Correlative studies"
647078|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given IM
Pharmacological Study: Correlative studies"
647079|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Bicalutamide: Given PO
Cixutumumab: Given IV
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given IM
Pharmacological Study: Correlative studies"
647080|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.
Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
647081|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
647082|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given IM
Pharmacological Study: Correlative studies"
647083|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Bicalutamide: Given PO
Cixutumumab: Given IV
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given IM
Pharmacological Study: Correlative studies"
647109|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647084|NCT01120236|E2|Reported Event|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.
Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
647085|NCT01120236|E1|Reported Event|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
647086|NCT01120275|B1|Baseline|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies"
647087|NCT01120275|P1|Participant Flow|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies"
647088|NCT01120275|O1|Outcome|RO4929097|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies"
647089|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies"
647123|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647415|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647090|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies"
647091|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies"
647092|NCT01120275|E1|Reported Event|RO4929097|Patients receive gamma-secretase/Notch signaling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
647093|NCT01120379|B1|Baseline|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647094|NCT01120379|P1|Participant Flow|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647095|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647096|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647097|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647098|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647099|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647100|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647101|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647102|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647103|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647104|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647105|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647106|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647107|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647108|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647110|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647111|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647112|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647113|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647114|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647115|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647116|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647117|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647118|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647119|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647120|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647121|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647218|NCT01120704|B33|Baseline|Total|Total of all reporting groups
647124|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647125|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647126|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647127|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647128|NCT01120379|E1|Reported Event|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
647129|NCT01120405|B3|Baseline|Total|Total of all reporting groups
647130|NCT01120405|B2|Baseline|Sevoflurane|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
647131|NCT01120405|B1|Baseline|Xenon|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
647132|NCT01120405|P2|Participant Flow|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647133|NCT01120405|P1|Participant Flow|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647134|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647135|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647136|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647137|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647138|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
647139|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
647140|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647141|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647142|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647143|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647144|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647145|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647146|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647147|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647148|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647149|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647150|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647151|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647152|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647153|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647154|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647155|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647156|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
647157|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
647158|NCT01120405|E2|Reported Event|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
651396|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
647161|NCT01120626|B2|Baseline|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)
sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
647162|NCT01120626|B1|Baseline|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)
donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
647163|NCT01120626|P2|Participant Flow|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)
sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
647164|NCT01120626|P1|Participant Flow|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)
donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
647165|NCT01120626|O2|Outcome|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)
sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
647166|NCT01120626|O1|Outcome|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)
donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
647167|NCT01120626|O2|Outcome|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)
sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
647168|NCT01120626|O1|Outcome|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)
donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
647169|NCT01120626|E2|Reported Event|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)
sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
647170|NCT01120626|E1|Reported Event|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)
donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
647171|NCT01120691|B4|Baseline|Total|Total of all reporting groups
647172|NCT01120691|B3|Baseline|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647173|NCT01120691|B2|Baseline|NVA237|NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
647416|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647174|NCT01120691|B1|Baseline|QVA149|QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
647175|NCT01120691|P3|Participant Flow|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647176|NCT01120691|P2|Participant Flow|NVA237|NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
647177|NCT01120691|P1|Participant Flow|QVA149|QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
647178|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647179|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647180|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647181|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647182|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647183|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647184|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647185|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647186|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647187|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647306|NCT01120717|B2|Baseline|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
647307|NCT01120717|B1|Baseline|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
647188|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647189|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647190|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647191|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647192|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647193|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks.Salbutamol/albuterol was available for rescue medication use throughout the study.
647194|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647195|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647335|NCT01114438|O1|Outcome|EndoBarrier Liner Device|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
647196|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647197|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647198|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647199|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647200|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647201|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647202|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647203|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647204|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647205|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647206|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647207|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647208|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647308|NCT01120717|P2|Participant Flow|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
652772|NCT01134731|E3|Reported Event|Placebo|
647209|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647210|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647211|NCT01120691|O2|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647212|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647213|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647214|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647215|NCT01120691|E3|Reported Event|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device. for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647216|NCT01120691|E2|Reported Event|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647217|NCT01120691|E1|Reported Event|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
647219|NCT01120704|B32|Baseline|32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647220|NCT01120704|B31|Baseline|31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647221|NCT01120704|B30|Baseline|30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647222|NCT01120704|B29|Baseline|29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647223|NCT01120704|B28|Baseline|28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647224|NCT01120704|B27|Baseline|27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647225|NCT01120704|B26|Baseline|26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647226|NCT01120704|B25|Baseline|25, 8Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647227|NCT01120704|B24|Baseline|24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647228|NCT01120704|B23|Baseline|23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647229|NCT01120704|B22|Baseline|22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
652773|NCT01134731|E2|Reported Event|Lithium|
647230|NCT01120704|B21|Baseline|21, 8Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647231|NCT01120704|B20|Baseline|20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647232|NCT01120704|B19|Baseline|19, 8Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647233|NCT01120704|B18|Baseline|18, 8Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647234|NCT01120704|B17|Baseline|17, 8Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647235|NCT01120704|B16|Baseline|16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647236|NCT01120704|B15|Baseline|15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647237|NCT01120704|B14|Baseline|14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647238|NCT01120704|B13|Baseline|13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647239|NCT01120704|B12|Baseline|12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647240|NCT01120704|B11|Baseline|11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647241|NCT01120704|B10|Baseline|10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647242|NCT01120704|B9|Baseline|9, 26Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647243|NCT01120704|B8|Baseline|8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647244|NCT01120704|B7|Baseline|7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647245|NCT01120704|B6|Baseline|6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647246|NCT01120704|B5|Baseline|5, 26Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647247|NCT01120704|B4|Baseline|4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647248|NCT01120704|B3|Baseline|3, 26Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647249|NCT01120704|B2|Baseline|2, 26Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647250|NCT01120704|B1|Baseline|1, 26Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647251|NCT01120704|P32|Participant Flow|32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647252|NCT01120704|P31|Participant Flow|31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647253|NCT01120704|P30|Participant Flow|30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647254|NCT01120704|P29|Participant Flow|29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647255|NCT01120704|P28|Participant Flow|28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647256|NCT01120704|P27|Participant Flow|27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647257|NCT01120704|P26|Participant Flow|26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647258|NCT01120704|P25|Participant Flow|25, 8Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647259|NCT01120704|P24|Participant Flow|24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647260|NCT01120704|P23|Participant Flow|23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647261|NCT01120704|P22|Participant Flow|22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647262|NCT01120704|P21|Participant Flow|21, 8Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647263|NCT01120704|P20|Participant Flow|20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647264|NCT01120704|P19|Participant Flow|19, 8Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647265|NCT01120704|P18|Participant Flow|18, 8Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647266|NCT01120704|P17|Participant Flow|17, 8Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647309|NCT01120717|P1|Participant Flow|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
647310|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
647267|NCT01120704|P16|Participant Flow|16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647268|NCT01120704|P15|Participant Flow|15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647269|NCT01120704|P14|Participant Flow|14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647270|NCT01120704|P13|Participant Flow|13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647271|NCT01120704|P12|Participant Flow|12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647272|NCT01120704|P11|Participant Flow|11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647273|NCT01120704|P10|Participant Flow|10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647274|NCT01120704|P9|Participant Flow|9, 26Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647336|NCT01114438|O1|Outcome|EndoBarrier Liner Device|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
650413|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
647275|NCT01120704|P8|Participant Flow|8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647276|NCT01120704|P7|Participant Flow|7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647277|NCT01120704|P6|Participant Flow|6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647278|NCT01120704|P5|Participant Flow|5, 26Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647279|NCT01120704|P4|Participant Flow|4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647280|NCT01120704|P3|Participant Flow|3, 26Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647281|NCT01120704|P2|Participant Flow|2, 26Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
647282|NCT01120704|P1|Participant Flow|1, 26Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
647311|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
647312|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
647313|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
647314|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
647315|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
647283|NCT01120704|O10|Outcome|Automated Adherence Prompting Phone Calls|Participants randomized to this condition received Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received No Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
647284|NCT01120704|O9|Outcome|No Automated Adherence Prompting Phone Calls|Participants randomized to this condition received No Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The No Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
647285|NCT01120704|O8|Outcome|Electronic Medication Monitoring Device Plus Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Plus Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Plus Feedback group consists of 270 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Without Feedback (N=274; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
647286|NCT01120704|O7|Outcome|Electronic Medication Monitoring Device Without Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Without Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Without Feedback group consists of 274 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Plus Feedback (N=270; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
647337|NCT01114438|E1|Reported Event|Device|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
647417|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
660695|NCT01150123|B19|Baseline|Total|Total of all reporting groups
647287|NCT01120704|O6|Outcome|Cognitive Medication Adherence Counseling|Participants randomized to this condition received Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Cognitive Medication Adherence Counseling group consists of 271 participants (approximately half the total sample of 544) who will be compared with a group that received No Cognitive Medication Adherence Counseling (N=273; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
647288|NCT01120704|O5|Outcome|No Cognitive Medication Adherence Counseling|Participants randomized to this condition received No Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Cognitive Medication Adherence Counseling group consists of 273 participants (approximately half the total sample of 544) who will be compared with a group that received Cognitive Medication Adherence Counseling (N=271; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
647289|NCT01120704|O4|Outcome|Maintenance Counseling|Participants randomized to this condition received Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Maintenance Counseling group consists of 263 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=281; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
647316|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
647317|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
652774|NCT01134731|E1|Reported Event|Paliperidone|
647290|NCT01120704|O3|Outcome|No Maintenance Counseling|Participants randomized to this condition received No Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Maintenance Counseling group consists of 281 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=263; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
647291|NCT01120704|O2|Outcome|26 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 26 Weeks of Nicotine Patch and Nicotine Gum group consists of 275 participants (approximately half the total sample of 544) who will be compared with a group that received 8 Weeks of Nicotine Patch and Nicotine Gum (N=269; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
647292|NCT01120704|O1|Outcome|8 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 8 Weeks of Nicotine Patch and Nicotine Gum group consists of 269 participants (approximately half the total sample of 544) who will be compared with a group that received 26 Weeks of Nicotine Patch and Nicotine Gum (N=275; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
647293|NCT01120704|O10|Outcome|Automated Adherence Prompting Phone Calls|Participants randomized to this condition received Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received No Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
647294|NCT01120704|O9|Outcome|No Automated Adherence Prompting Phone Calls|Participants randomized to this condition received No Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The No Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
661283|NCT01151436|O1|Outcome|Hyaluronic Acid|
647295|NCT01120704|O8|Outcome|Electronic Medication Monitoring Device Plus Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Plus Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Plus Feedback group consists of 270 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Without Feedback (N=274; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
647296|NCT01120704|O7|Outcome|Electronic Medication Monitoring Device Without Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Without Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Without Feedback group consists of 274 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Plus Feedback (N=270; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
647318|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
647319|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
647320|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
647321|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
647322|NCT01120717|E2|Reported Event|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
647297|NCT01120704|O6|Outcome|Cognitive Medication Adherence Counseling|Participants randomized to this condition received Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Cognitive Medication Adherence Counseling group consists of 271 participants (approximately half the total sample of 544) who will be compared with a group that received No Cognitive Medication Adherence Counseling (N=273; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
647298|NCT01120704|O5|Outcome|No Cognitive Medication Adherence Counseling|Participants randomized to this condition received No Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Cognitive Medication Adherence Counseling group consists of 273 participants (approximately half the total sample of 544) who will be compared with a group that received Cognitive Medication Adherence Counseling (N=271; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
647299|NCT01120704|O4|Outcome|Maintenance Counseling|Participants randomized to this condition received Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Maintenance Counseling group consists of 263 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=281; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
647300|NCT01120704|O3|Outcome|No Maintenance Counseling|Participants randomized to this condition received No Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Maintenance Counseling group consists of 281 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=263; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
647301|NCT01120704|O2|Outcome|26 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 26 Weeks of Nicotine Patch and Nicotine Gum group consists of 275 participants (approximately half the total sample of 544) who will be compared with a group that received 8 Weeks of Nicotine Patch and Nicotine Gum (N=269; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
647302|NCT01120704|O1|Outcome|8 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 8 Weeks of Nicotine Patch and Nicotine Gum group consists of 269 participants (approximately half the total sample of 544) who will be compared with a group that received 26 Weeks of Nicotine Patch and Nicotine Gum (N=275; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
647303|NCT01120704|E2|Reported Event|8 Weeks of Nicotine Patch and Nicotine Gum|"Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum.
IF participant smoked >10 cigs/day AND is randomized to a 8 week condition: they were asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants were also asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.
IF participant smoked 5-10 cigs/day AND is randomized to the 8 week medication condition: they were asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants were also asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment."
647304|NCT01120704|E1|Reported Event|26 Weeks of Nicotine Patch and Nicotine Gum|"Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum.
IF the participant smoked >10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants were also asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.
IF the participant smoked 5-10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants were also asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication"
647323|NCT01120717|E1|Reported Event|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
647324|NCT01120782|B1|Baseline|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
647325|NCT01120782|P1|Participant Flow|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
647326|NCT01120782|O1|Outcome|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
647327|NCT01120782|E1|Reported Event|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
647328|NCT01114438|B1|Baseline|EndoBarrier Gastrointestinal Liner|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
647329|NCT01114438|P1|Participant Flow|EndoBarrier Gastrointestinal Liner|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
647330|NCT01114438|O2|Outcome|Device at 6 Months Post-explant|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner was implanted in participants for 12 months and then removed.
647331|NCT01114438|O1|Outcome|Device at Month 12 (Explant)|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner was implanted in participants for 12 months and then removed
647332|NCT01114438|O3|Outcome|No Change in Glucose-Lowering Meds at Week 52|Subjects implanted with device for 12 Months with no change in medication at the time of device removal compared to Baseline medication levels
647333|NCT01114438|O2|Outcome|Increase in Glucose-Lowering Meds at Week 52|Subjects implanted with device for 12 Months with an Increase in medication at the time of device removal compared to Baseline medication levels
647334|NCT01114438|O1|Outcome|Decrease in Glucose-Lowering Meds|Subjects implanted with device for 12 Months with an Decrease in medication at the time of device removal compared to Baseline medication levels
647413|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647338|NCT01114503|B1|Baseline|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647339|NCT01114503|P1|Participant Flow|Otelixizumab Cohort A1|Eligible participants received a total intravenous (IV) dose of otelixizumab 3.1 milligram (mg) for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 hours (h). The rate of infusion was 0.05 milligram per hour (mg/h) on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647340|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647341|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647394|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
647395|NCT01114529|E3|Reported Event|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
647396|NCT01114529|E2|Reported Event|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid) and steroids
647397|NCT01114529|E1|Reported Event|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
650449|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
647342|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647343|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647344|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647345|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
661284|NCT01151436|O1|Outcome|Hyaluronic Acid|
647346|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647347|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647348|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647349|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
652775|NCT01134783|B3|Baseline|Total|Total of all reporting groups
647350|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647351|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647352|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647353|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647414|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647354|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647355|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647356|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647357|NCT01114503|O1|Outcome|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647358|NCT01114503|E1|Reported Event|Otelixizumab Cohort A1|Eligible participants received a IV dose of otelixizumab 3.1 mg for 8 days. The planned dosing regimen was 0.1 mg on Day 1, 0.2 mg on Day 2, 0.3 mg on Day 3, 0.5 mg on Day 4 to Day 8. The study medication was administered each day for 2 h. The rate of infusion was 0.05 mg/h on Day 1, 0.1 mg/h on Day 2, 0.15 mg/h on Day 3, 0.25 mg/h on Day 4 to Day 8. At the start of each cohort in Part A, 2 participants acted as sentinel participants and complete dosing (Days 1–8) before further participants were dosed with otelixizumab. The first sentinel participants completed all of their dosing days and there was a minimum of 24 h elapse before the second sentinel participant started the dosing regimen. Further participants commenced dosing with otelixizumab once 24 h elapsed from the second sentinel participant receiving the final dose of otelixizumab on Day 8. Subsequent participants were dosed concurrently.
647359|NCT01114516|B3|Baseline|Total|Total of all reporting groups
647360|NCT01114516|B2|Baseline|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin
Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
647361|NCT01114516|B1|Baseline|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
647362|NCT01114516|P2|Participant Flow|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin
Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
647363|NCT01114516|P1|Participant Flow|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
647364|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin
Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
647365|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
647366|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin
Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
647367|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
647368|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin
Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
647369|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
647370|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin
Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
647371|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
647372|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin
Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
647373|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
661285|NCT01151436|O1|Outcome|Hyaluronic Acid|
647374|NCT01114516|E2|Reported Event|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin
Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
647375|NCT01114516|E1|Reported Event|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
647376|NCT01114529|B4|Baseline|Total|Total of all reporting groups
647377|NCT01114529|B3|Baseline|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
647378|NCT01114529|B2|Baseline|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
647379|NCT01114529|B1|Baseline|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
647380|NCT01114529|P3|Participant Flow|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
647381|NCT01114529|P2|Participant Flow|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
647382|NCT01114529|P1|Participant Flow|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
647383|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
647384|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
647385|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
647386|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid), and steroids
647387|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid) and steroids
647388|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
647389|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
647390|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
647391|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
647392|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid), and steroids
647393|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid) and steroids
647398|NCT01120808|B1|Baseline|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
647399|NCT01120808|P1|Participant Flow|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
647400|NCT01120808|O1|Outcome|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
647401|NCT01120808|E1|Reported Event|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
647402|NCT01120834|B1|Baseline|All Subjects|"azacytidine: • Dose level 1: azacitidine 55 mg/m2 on days 1-5
Dose level 2: azacitidine 75 mg/m2 on days 1-5
Dose level 3: azacitidine 55 mg/m2 on days 1-5
Dose level 4: azacitidine 75 mg/m2 on days 1-5
Each cycle = 28 days. Subjects may receive up to 6 cycles.
vorinostat: • Dose level 1: oral vorinostat at 300 mg BID on Days 1-7.
Dose level 2: oral vorinostat at 200 mg BID on Days 1-7.
Dose level 3: oral vorinostat at 300 mg BID on Days 1-14.
Dose level 4: oral vorinostat at 200 mg BID on Days 1-14.
Each cycle = 28 days. Subjects receive up to 6 cycles."
647403|NCT01120834|P1|Participant Flow|All Subjects|"azacytidine: • Dose level 1: azacitidine 55 mg/m2 on days 1-5
Dose level 2: azacitidine 75 mg/m2 on days 1-5
Dose level 3: azacitidine 55 mg/m2 on days 1-5
Dose level 4: azacitidine 75 mg/m2 on days 1-5
Each cycle = 28 days. Subjects may receive up to 6 cycles.
vorinostat: • Dose level 1: oral vorinostat at 300 mg BID on Days 1-7.
Dose level 2: oral vorinostat at 200 mg BID on Days 1-7.
Dose level 3: oral vorinostat at 300 mg BID on Days 1-14.
Dose level 4: oral vorinostat at 200 mg BID on Days 1-14.
Each cycle = 28 days. Subjects receive up to 6 cycles."
647404|NCT01120834|O1|Outcome|All Subjects|
647405|NCT01120834|E1|Reported Event|All Subjects|all subjects
647406|NCT01120899|B1|Baseline|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647407|NCT01120899|P1|Participant Flow|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647408|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647409|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647410|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647411|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647412|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
661286|NCT01151436|O1|Outcome|Hyaluronic Acid|
647418|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647419|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647420|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647421|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647422|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647423|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647424|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647425|NCT01120899|E1|Reported Event|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
647426|NCT01120990|B1|Baseline|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
647427|NCT01120990|P1|Participant Flow|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
647428|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
647429|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
647430|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
647431|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
647432|NCT01120990|E1|Reported Event|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
647433|NCT01121484|B3|Baseline|Total|Total of all reporting groups
647434|NCT01121484|B2|Baseline|Placebo|Matching placebo tablets once daily for 10 weeks
647435|NCT01121484|B1|Baseline|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
647436|NCT01121484|P2|Participant Flow|Placebo|Matching placebo tablets once daily for 10 weeks
647437|NCT01121484|P1|Participant Flow|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
647438|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
647439|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
647440|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
647441|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
647443|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
647444|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
647445|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
647446|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
647447|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
647448|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
647449|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
647450|NCT01121484|E2|Reported Event|Placebo|Matching placebo tablets once daily for 10 weeks
647451|NCT01121484|E1|Reported Event|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
647452|NCT01121536|B1|Baseline|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647453|NCT01121536|P1|Participant Flow|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647454|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647455|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647456|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647457|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647458|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647459|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647460|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647461|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647462|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647463|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647464|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647465|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647671|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647466|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647467|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647468|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647469|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647470|NCT01121536|E1|Reported Event|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
647471|NCT01121549|B1|Baseline|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
647472|NCT01121549|P1|Participant Flow|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
647473|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
647643|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647474|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
647475|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
647476|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
647477|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
647478|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
647479|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
647480|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
647481|NCT01121549|E1|Reported Event|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
647482|NCT01121562|B1|Baseline|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
647483|NCT01121562|P1|Participant Flow|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
647484|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
647485|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
647486|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
647487|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
647488|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
647489|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
647490|NCT01121562|E1|Reported Event|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
647491|NCT01121575|B7|Baseline|Total|Total of all reporting groups
647512|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
647492|NCT01121575|B6|Baseline|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647493|NCT01121575|B5|Baseline|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647494|NCT01121575|B4|Baseline|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647495|NCT01121575|B3|Baseline|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647496|NCT01121575|B2|Baseline|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647497|NCT01121575|B1|Baseline|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647498|NCT01121575|P6|Participant Flow|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647499|NCT01121575|P5|Participant Flow|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647500|NCT01121575|P4|Participant Flow|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647501|NCT01121575|P3|Participant Flow|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647502|NCT01121575|P2|Participant Flow|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647503|NCT01121575|P1|Participant Flow|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg twice a day (BID) and oral dacomitinib 30 mg once daily (QD). The first cycle was for 28 days thereafter, each cycle was 21 days.
647504|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
647505|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
647506|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
647507|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
647508|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
647509|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
647510|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
647511|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
647513|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
650450|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
647514|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
647515|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
647516|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
647517|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
647518|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
647519|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
647520|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
647521|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
647522|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
647523|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
647524|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
647525|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
647526|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule.
647527|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
647528|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647529|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647530|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647531|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647532|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647533|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647534|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647535|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647536|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647537|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647538|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647539|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647540|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647541|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647542|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647543|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647544|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647545|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647546|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647547|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647548|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647549|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647550|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647551|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647552|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647553|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647554|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647555|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647556|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647557|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647558|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647559|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647560|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647561|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647562|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647563|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647564|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647565|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647566|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647567|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647568|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647569|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647621|NCT01121575|E5|Reported Event|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647570|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647571|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647572|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647573|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647574|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647575|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647611|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647576|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647577|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647578|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647579|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647580|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647581|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
650451|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
647582|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647583|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647584|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647585|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647586|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647587|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647588|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647589|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647609|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647590|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647591|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647592|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647593|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647594|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647595|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647596|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647597|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647670|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647598|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647599|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647600|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647601|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647602|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647603|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647604|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647605|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647606|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647607|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647608|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647610|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647612|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647613|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647614|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647615|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
647616|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647617|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647618|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647619|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
647620|NCT01121575|E6|Reported Event|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
647622|NCT01121575|E4|Reported Event|PF-02341066, 250 mg QD/ PF-00299804, 45 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
647623|NCT01121575|E3|Reported Event|PF-02341066, 250 mg BID/ PF-00299804, 30 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
647624|NCT01121575|E2|Reported Event|PF-02341066, 200 mg BID/ PF-00299804, 45 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
647625|NCT01121575|E1|Reported Event|PF-02341066, 200 mg BID/ PF-00299804, 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
647626|NCT01121666|B3|Baseline|Total|Total of all reporting groups
647627|NCT01121666|B2|Baseline|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647628|NCT01121666|B1|Baseline|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647629|NCT01121666|P2|Participant Flow|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647630|NCT01121666|P1|Participant Flow|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647631|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647632|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647633|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647634|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647635|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647636|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647637|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647638|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647639|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647640|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647641|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647642|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647644|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647645|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647646|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647647|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647648|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647649|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647650|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647651|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647652|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647653|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647654|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647655|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647656|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647657|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647658|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647659|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647660|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647661|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647662|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647663|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647664|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647665|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647666|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647667|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647668|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647669|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
655161|NCT01140061|B11|Baseline|Total|Total of all reporting groups
647672|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647673|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647674|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647675|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647676|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647677|NCT01121666|E2|Reported Event|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647678|NCT01121666|E1|Reported Event|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
647679|NCT01121757|B3|Baseline|Total|Total of all reporting groups
647680|NCT01121757|B2|Baseline|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.
Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647681|NCT01121757|B1|Baseline|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.
Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647682|NCT01121757|P2|Participant Flow|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.
Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
661287|NCT01151436|O1|Outcome|Hyaluronic Acid|
647683|NCT01121757|P1|Participant Flow|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.
Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647684|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.
Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647685|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.
Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647686|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.
Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647687|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.
Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647699|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
648806|NCT01117948|B1|Baseline|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
647688|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.
Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647689|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.
Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647690|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.
Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647691|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.
Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647692|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.
Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647736|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
647737|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
647693|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.
Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647694|NCT01121757|E2|Reported Event|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.
Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647695|NCT01121757|E1|Reported Event|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.
Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.
Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.
The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
647696|NCT01121900|B1|Baseline|Entire Study Population|Includes groups randomized to receive Test first and Reference first.
647697|NCT01121900|P2|Participant Flow|Reference (Trazodone IR [Apotex Corp.]) First|"Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.
IR = Immediate Release."
647698|NCT01121900|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.
IR = Immediate Release."
647801|NCT01122030|P6|Participant Flow|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647700|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647701|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647702|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647703|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647704|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647705|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647706|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647707|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647708|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647738|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
650414|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
647709|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647710|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647711|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647712|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647713|NCT01121900|E2|Reported Event|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647714|NCT01121900|E1|Reported Event|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647715|NCT01121913|B1|Baseline|Entire Study Population|Includes groups randomized to receive Trazodone Contramid® OAD (prototype 1) First, Trazodone Contramid® OAD (prototype 2) First, Triticco® First, and Desyrel® First.
647716|NCT01121913|P4|Participant Flow|Desyrel® First|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase I; followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase II; 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
647717|NCT01121913|P3|Participant Flow|Triticco® First|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase I; followed by 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
647846|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647718|NCT01121913|P2|Participant Flow|Trazodone Contramid® OAD (Prototype 2) First|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase I, followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase II; 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase III; and 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
647719|NCT01121913|P1|Participant Flow|Trazodone Contramid® OAD (Prototype 1) First|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase I; followed by 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase III; and 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
647720|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
647721|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
647722|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
647723|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
647724|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
647725|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
647726|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
647727|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
647728|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
647729|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
647730|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
647731|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
647732|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
647733|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
647734|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
647735|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
647739|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
647740|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
647741|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
647742|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
647743|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
647744|NCT01121913|E4|Reported Event|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
647745|NCT01121913|E3|Reported Event|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
647746|NCT01121913|E2|Reported Event|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
647747|NCT01121913|E1|Reported Event|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
647748|NCT01121926|B1|Baseline|Entire Study Population|"Includes groups randomized to receive Trazodone Contramid® OAD (Once-A-Day) test product first and Trazodone IR (Apotex Corp.) reference product first.
IR = Immediate Release"
647749|NCT01121926|P2|Participant Flow|Reference (Trazodone IR [Apotex Corp.]) First|"Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
IR = Immediate Release."
647750|NCT01121926|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
IR = Immediate Release."
647751|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647752|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647753|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647754|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647755|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647756|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647757|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647758|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647759|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647760|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647761|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647762|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647763|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647764|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647765|NCT01121926|E2|Reported Event|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647766|NCT01121926|E1|Reported Event|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
647767|NCT01121939|B1|Baseline|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over
90 minutes. If no adverse reactions occur after the initial dose, the second dose should
be administered over a minimum of 60 minutes. If no adverse reactions occur after the
second dose, all subsequent doses should be administered over a minimum of 30
minutes. Bevacizumab will be infused prior to pertuzumab.
Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.
Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
647768|NCT01121939|P1|Participant Flow|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over
90 minutes. If no adverse reactions occur after the initial dose, the second dose should
be administered over a minimum of 60 minutes. If no adverse reactions occur after the
second dose, all subsequent doses should be administered over a minimum of 30
minutes. Bevacizumab will be infused prior to pertuzumab.
Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.
Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
647769|NCT01121939|O3|Outcome|All Patients|All patients on study (treatment is same for all patients)
647770|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
647771|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
647772|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
647773|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
647774|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
647775|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
647802|NCT01122030|P5|Participant Flow|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647803|NCT01122030|P4|Participant Flow|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647847|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647776|NCT01121939|O1|Outcome|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over
90 minutes. If no adverse reactions occur after the initial dose, the second dose should
be administered over a minimum of 60 minutes. If no adverse reactions occur after the
second dose, all subsequent doses should be administered over a minimum of 30
minutes. Bevacizumab will be infused prior to pertuzumab.
Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.
Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
647777|NCT01121939|O3|Outcome|All Patients|All patients on study (treatment is same for all patients)
647778|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
647779|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
647780|NCT01121939|E1|Reported Event|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over
90 minutes. If no adverse reactions occur after the initial dose, the second dose should
be administered over a minimum of 60 minutes. If no adverse reactions occur after the
second dose, all subsequent doses should be administered over a minimum of 30
minutes. Bevacizumab will be infused prior to pertuzumab.
Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.
Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
647781|NCT01121991|B1|Baseline|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
647782|NCT01121991|P1|Participant Flow|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
647783|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
647784|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
647785|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
647786|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
647787|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
650415|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
647788|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
647789|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
647790|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
647791|NCT01121991|E1|Reported Event|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
647792|NCT01122030|B8|Baseline|Total|Total of all reporting groups
647793|NCT01122030|B7|Baseline|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647794|NCT01122030|B6|Baseline|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647795|NCT01122030|B5|Baseline|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647796|NCT01122030|B4|Baseline|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647797|NCT01122030|B3|Baseline|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647798|NCT01122030|B2|Baseline|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647799|NCT01122030|B1|Baseline|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647800|NCT01122030|P7|Participant Flow|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
656606|NCT01146873|B3|Baseline|Total|Total of all reporting groups
647804|NCT01122030|P3|Participant Flow|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647805|NCT01122030|P2|Participant Flow|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647806|NCT01122030|P1|Participant Flow|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647807|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647808|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647809|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647810|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647811|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647812|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647813|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647814|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647815|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647816|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647817|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647818|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647819|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647820|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647821|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647822|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647823|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647824|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647825|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
649453|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
647826|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647827|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647828|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647829|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647830|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647831|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647832|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647833|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647834|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647835|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647836|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647837|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647838|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647839|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647840|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647841|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647842|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647843|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647844|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647845|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647848|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647849|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647850|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647851|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647852|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647853|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647854|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647855|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647856|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647857|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647858|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647859|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647860|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647861|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647862|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647863|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647864|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647865|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647866|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647867|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647868|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647869|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647870|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647871|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647872|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647873|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647874|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647875|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647876|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647877|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647878|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647879|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647880|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647881|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647882|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647883|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647884|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647885|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647886|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647887|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647888|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647889|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647890|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647891|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647892|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647893|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647894|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647895|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647896|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647897|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647898|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647899|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647900|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647901|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647902|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647903|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647904|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647905|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647906|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647907|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647908|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647909|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647910|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647911|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647912|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647913|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647914|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647915|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647916|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647917|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647918|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647919|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647920|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647921|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647922|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647923|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647924|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647925|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647926|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647927|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647928|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647929|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647930|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647931|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647932|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647933|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647934|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647935|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647936|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647937|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647938|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647939|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647940|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647941|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647942|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647943|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647944|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647945|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647946|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647947|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647948|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647949|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647950|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647951|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647952|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647953|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647954|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647955|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647956|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647957|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647958|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647959|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647960|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647961|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647962|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647963|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647964|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647965|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647966|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647967|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647968|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647969|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647970|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647971|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647972|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647973|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647974|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647975|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647976|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647977|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647978|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
647979|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647980|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647981|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647982|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647983|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647984|NCT01122030|E7|Reported Event|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647985|NCT01122030|E6|Reported Event|Naldemedine 1 mg|Participants received a single dose of 1mg naldemedine tablets administered on Day 15 under fasted conditions.
647986|NCT01122030|E5|Reported Event|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
647987|NCT01122030|E4|Reported Event|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
647988|NCT01122030|E3|Reported Event|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647989|NCT01122030|E2|Reported Event|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
647990|NCT01122030|E1|Reported Event|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
647991|NCT01122108|B1|Baseline|Colesevelam HCl (3.75g) vs Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
647992|NCT01122108|P2|Participant Flow|Cholestyramine 12g First, Then Colesevelam HCl 3.75|Cholestyramine 12g once orally in the first intervention and Colesevelam 3.75g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.
647993|NCT01122108|P1|Participant Flow|Colesevelam HCl 3.75g First, Then Cholestyramine 12g|Colesevelam HCl 3.75g once orally in the first intervention and Cholestyramine 12g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.
647994|NCT01122108|O2|Outcome|Cholestyramine (12g)|
648155|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
647995|NCT01122108|O1|Outcome|Colesevelam HCl (3.75g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
647996|NCT01122108|O2|Outcome|Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
647997|NCT01122108|O1|Outcome|Colesevelam HCl (3.75g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
647998|NCT01122108|E3|Reported Event|More Than 30 Minutes After Last Beverage|This group summarizes the adverse events that occurred more than 30 mintures after the last beverage administered, and thus cannot be attributed to one specific bile acid sequestrant.
647999|NCT01122108|E2|Reported Event|Colesevelam HCl (3.75 Grams)|
648000|NCT01122108|E1|Reported Event|Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
648001|NCT01122160|B1|Baseline|All Study Participants|All participants received both interventions.
648002|NCT01122160|P2|Participant Flow|Omeprazole First, Then Placebo|Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries), followed by placebo with berries (blackberries + strawberries)
648003|NCT01122160|P1|Participant Flow|Placebo First, Then Omeprazole|Placebo with berries (blackberries + strawberries), followed by Omeprazole with berries (blackberries + strawberries)
648004|NCT01122160|O2|Outcome|Placebo|
648005|NCT01122160|O1|Outcome|Experimental|
648006|NCT01122160|E2|Reported Event|Placebo|
648007|NCT01122160|E1|Reported Event|Experimental|
648008|NCT01122238|B17|Baseline|Total|Total of all reporting groups
648009|NCT01122238|B16|Baseline|16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648010|NCT01122238|B15|Baseline|15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648011|NCT01122238|B14|Baseline|14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648012|NCT01122238|B13|Baseline|13, No Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648131|NCT01122381|E1|Reported Event|Arm 1- Ethosuximide|ethosuximide blinded capsules of 250mg ESX; subject was titrated up to 4 capsules qd
648013|NCT01122238|B12|Baseline|12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648014|NCT01122238|B11|Baseline|11, No Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648015|NCT01122238|B10|Baseline|10, No Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648016|NCT01122238|B9|Baseline|9, No Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648017|NCT01122238|B8|Baseline|8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648018|NCT01122238|B7|Baseline|7, Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648019|NCT01122238|B6|Baseline|6, Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648020|NCT01122238|B5|Baseline|5, Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648021|NCT01122238|B4|Baseline|4, Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648022|NCT01122238|B3|Baseline|3, Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648023|NCT01122238|B2|Baseline|2, Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648024|NCT01122238|B1|Baseline|1, Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648156|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
650416|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
648025|NCT01122238|P16|Participant Flow|16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648026|NCT01122238|P15|Participant Flow|15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648027|NCT01122238|P14|Participant Flow|14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648028|NCT01122238|P13|Participant Flow|13, No Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648029|NCT01122238|P12|Participant Flow|12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648030|NCT01122238|P11|Participant Flow|11, No Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648031|NCT01122238|P10|Participant Flow|10, No Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648032|NCT01122238|P9|Participant Flow|9, No Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648033|NCT01122238|P8|Participant Flow|8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648034|NCT01122238|P7|Participant Flow|7, Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648035|NCT01122238|P6|Participant Flow|6, Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648036|NCT01122238|P5|Participant Flow|5, Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648037|NCT01122238|P4|Participant Flow|4, Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648038|NCT01122238|P3|Participant Flow|3, Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648039|NCT01122238|P2|Participant Flow|2, Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
648040|NCT01122238|P1|Participant Flow|1, Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:
How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
648041|NCT01122238|O8|Outcome|No Motivational Interviewing|All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
648042|NCT01122238|O7|Outcome|Motivational Interviewing|All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
648043|NCT01122238|O6|Outcome|No Smoking Reduction|All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
648083|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648084|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
650417|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
648044|NCT01122238|O5|Outcome|Smoking Reduction|All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
648045|NCT01122238|O4|Outcome|No Nicotine Gum|All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
648046|NCT01122238|O3|Outcome|Nicotine Gum|All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
648047|NCT01122238|O2|Outcome|No Nicotine Patch|All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
648048|NCT01122238|O1|Outcome|Nicotine Patch|All participants in this group received Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Patch group consists of 265 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Patch group consisting of 252 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
648065|NCT01122264|P3|Participant Flow|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648066|NCT01122264|P2|Participant Flow|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648049|NCT01122238|O8|Outcome|No Motivational Interviewing|All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
648050|NCT01122238|O7|Outcome|Motivational Interviewing|All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
648051|NCT01122238|O6|Outcome|No Smoking Reduction|All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
648052|NCT01122238|O5|Outcome|Smoking Reduction|All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
648053|NCT01122238|O4|Outcome|No Nicotine Gum|All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
648054|NCT01122238|O3|Outcome|Nicotine Gum|All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
648085|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648055|NCT01122238|O2|Outcome|No Nicotine Patch|All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
648056|NCT01122238|O1|Outcome|Nicotine Patch|All participants in this group received Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Patch group consists of 265 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Patch group consisting of 252 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
648057|NCT01122238|E4|Reported Event|No Medication|"No Medication
Participants randomized to this condition received no medication."
648058|NCT01122238|E3|Reported Event|Prequit Nicotine Gum Only|"Prequit Nicotine Gum Only.
Participants randomized to this condition received a 6-week supply of 2 mg gum at the initial visit. Participants will be instructed to use 10 pieces of gum daily for 6 weeks."
648059|NCT01122238|E2|Reported Event|Prequit Nicotine Patch Only|"Prequit Nicotine Patch Only
Participants randomized to this condition received a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks."
648060|NCT01122238|E1|Reported Event|Prequit Combined Nicotine Patch + Gum|"Prequit Combined Nicotine Patch + Gum
Participants randomized to this condition received a 6-week supply of 14 mg patches and a 6-week supply of 2 mg gum at the initial visit. Participant will be instructed to use one patch daily and to use 10 pieces of gum daily for 6 weeks."
648061|NCT01122264|B4|Baseline|Total|Total of all reporting groups
648062|NCT01122264|B3|Baseline|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648063|NCT01122264|B2|Baseline|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648064|NCT01122264|B1|Baseline|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648100|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648067|NCT01122264|P1|Participant Flow|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648068|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648069|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648070|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648071|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648072|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648073|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648074|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648075|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648076|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648077|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648078|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648079|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648080|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648081|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648082|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648153|NCT01122511|P1|Participant Flow|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
648086|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648087|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648088|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648089|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648090|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648091|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648092|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).
648093|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tadalafil tablet orally, once a day.
648094|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).
648095|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648096|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648097|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648098|NCT01122264|O1|Outcome|Entire Study Population|"Tadalafil On Demand: Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).
Tadalafil Once a Day: Participants were instructed to take a 5-mg or 2.5-mg tadalafil tablet orally, once a day.
Sildenafil Citrate On Demand: Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day)."
648099|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648132|NCT01122394|B3|Baseline|Total|Total of all reporting groups
648101|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648102|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648103|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648104|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648105|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648106|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648107|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648108|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648109|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648110|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648111|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648112|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648113|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648114|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648115|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648116|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
661288|NCT01151436|O1|Outcome|Hyaluronic Acid|
648117|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648118|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648119|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648120|NCT01122264|E3|Reported Event|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648121|NCT01122264|E2|Reported Event|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
648122|NCT01122264|E1|Reported Event|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
648123|NCT01122381|B3|Baseline|Total|Total of all reporting groups
648124|NCT01122381|B2|Baseline|Arm 2|"placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability
placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability"
648125|NCT01122381|B1|Baseline|Arm 1|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria
ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability"
648126|NCT01122381|P2|Participant Flow|Arm 2-placebo|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria
placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability"
648127|NCT01122381|P1|Participant Flow|Arm 1-drug Treatment|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria
ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability"
648128|NCT01122381|O2|Outcome|Arm 2-placebo Comparator|Study was terminated early-no outcome data available. Only one subject was assigned to study placebo but was dis-enrolled after titration phase due to study termination.
648129|NCT01122381|O1|Outcome|Arm 1-ethosuximide|Study was terminated early-no outcome data available. Only one subject was assigned to study drug arm but did not actually take it according to subsequent review of ESX drug levels.
648130|NCT01122381|E2|Reported Event|Arm 2- Placebo Comparator|"placebo blinded capsules of 250mg; subject was titrated up to 4 capsules qd"
656790|NCT01147406|P6|Participant Flow|Placebo|Not Active - Placebo
648133|NCT01122394|B2|Baseline|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
648134|NCT01122394|B1|Baseline|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
648135|NCT01122394|P2|Participant Flow|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
648136|NCT01122394|P1|Participant Flow|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
648137|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
648138|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
648139|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
648140|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
648141|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
648142|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
648143|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
648144|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
648145|NCT01122394|O2|Outcome|Attention Placebo (AP)|"Attention Placebo
AP: Attention placebo"
648146|NCT01122394|O1|Outcome|Tailored Intervention (TI)|"Tailored intervention based on the transtheoretical model
TI: Tailored intervention based on the transtheoretical model"
648147|NCT01122394|E2|Reported Event|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
648148|NCT01122394|E1|Reported Event|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
648149|NCT01122511|B3|Baseline|Total|Total of all reporting groups
648150|NCT01122511|B2|Baseline|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
648151|NCT01122511|B1|Baseline|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
648152|NCT01122511|P2|Participant Flow|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
648154|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
648157|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
648158|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
648159|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
648160|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
648161|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
648162|NCT01122511|E2|Reported Event|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
648163|NCT01122511|E1|Reported Event|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
648164|NCT01122576|B4|Baseline|Total|Total of all reporting groups
648165|NCT01122576|B3|Baseline|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648166|NCT01122576|B2|Baseline|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648167|NCT01122576|B1|Baseline|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648168|NCT01122576|P3|Participant Flow|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL :Tecnis surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
648169|NCT01122576|P2|Participant Flow|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
648170|NCT01122576|P1|Participant Flow|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
648171|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648172|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648173|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648174|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648175|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648176|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648177|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648178|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648179|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648180|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648181|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648182|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648183|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648184|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648185|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648186|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648187|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
649459|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
648188|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648189|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648190|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648191|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648192|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648193|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648194|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648195|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648196|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648197|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648198|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648199|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648200|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648201|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648807|NCT01117948|P2|Participant Flow|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
648202|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648203|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648204|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648205|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648206|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648207|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648208|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648209|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648210|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648211|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648212|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648213|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648214|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648215|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648216|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648217|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648218|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648219|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648220|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648221|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648222|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648223|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648224|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648225|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648226|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648227|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648228|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648229|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648230|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648231|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648232|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648233|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648234|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648235|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648236|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648237|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648238|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648239|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648240|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648241|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648242|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648243|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648244|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648245|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648246|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648247|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648248|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648249|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648250|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648251|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648252|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648253|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648254|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648255|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648256|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648257|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648258|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648259|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648260|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648261|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648262|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648263|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648264|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648265|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648266|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648267|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648268|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648269|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648270|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648271|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648272|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648273|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648274|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648275|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648276|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648277|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and wer implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648278|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648279|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648280|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648281|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648282|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648283|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648284|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648285|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648286|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648287|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648288|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648289|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648290|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648291|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648292|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648293|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648294|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648295|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648296|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648297|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648298|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648299|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648300|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648301|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648302|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648303|NCT01122576|E3|Reported Event|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
648304|NCT01122576|E2|Reported Event|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
648305|NCT01122576|E1|Reported Event|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
648306|NCT01122680|B1|Baseline|Total.|Total number of patients randomised and treated at all in the study.
648307|NCT01122680|P4|Participant Flow|Tio R2.5/Tio R1.25/Placebo|Patients treated with Tiotropium 2.5 mcg in Phase I, with Tiotropium 1.25 mcg in Phase II and with a matching Placebo in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
648308|NCT01122680|P3|Participant Flow|Placebo/Tio R2.5/Tio R5|Patients treated with a matching Placebo in Phase I, with Tiotropium 2.5 mcg in Phase II and with Tiotropium 5 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
648309|NCT01122680|P2|Participant Flow|Tio R1.25/Tio R5/Tio R2.5|Patients treated with Tiotropium 1.25 mcg in Phase I, with Tiotropium 5 mcg in Phase II and with Tiotropium 2.5 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
648310|NCT01122680|P1|Participant Flow|Tio R5/Placebo/Tio R1.25|Patients treated with Tiotropium 5 mcg in Phase I, with a matching Placebo in Phase II and with Tiotropium 1.25 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
648311|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
650452|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
648312|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648313|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648314|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648315|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648316|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648317|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648318|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648319|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648320|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648321|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648322|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648323|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648324|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648325|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648326|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648327|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648328|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648329|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648330|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648331|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648332|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648333|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648334|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648335|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648336|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648337|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648338|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648339|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648340|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648341|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648342|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648343|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648344|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
649203|NCT01124097|B2|Baseline|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
648345|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648346|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648347|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648348|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648349|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648350|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648351|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648352|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648353|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648354|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648355|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648356|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648357|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648358|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648359|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648360|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648361|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
649624|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
648362|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648363|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648364|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648365|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648366|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648367|NCT01122680|E4|Reported Event|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648368|NCT01122680|E3|Reported Event|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648369|NCT01122680|E2|Reported Event|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648370|NCT01122680|E1|Reported Event|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
648371|NCT01122862|B1|Baseline|All Randomized Participants|All randomized participants were included for baseline parameters evaluation.
648372|NCT01122862|P3|Participant Flow|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648373|NCT01122862|P2|Participant Flow|Chlorhexidine Mouth Rinse (0.12%)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% weight by volume (w/v) chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648374|NCT01122862|P1|Participant Flow|Test Mouth Rinse|Participants swirled their oral cavity with 15 milliliters (mL) of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648375|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648376|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
650453|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
648377|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648378|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648379|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648380|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648381|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648382|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648383|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648384|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648385|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648386|NCT01122862|O2|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648387|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648388|NCT01122862|E3|Reported Event|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648389|NCT01122862|E2|Reported Event|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648390|NCT01122862|E1|Reported Event|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
648391|NCT01122901|B3|Baseline|Total|Total of all reporting groups
648392|NCT01122901|B2|Baseline|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648393|NCT01122901|B1|Baseline|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
pharmacological study: Correlative studies"
648394|NCT01122901|P2|Participant Flow|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648395|NCT01122901|P1|Participant Flow|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
pharmacological study: Correlative studies"
648396|NCT01122901|O3|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648397|NCT01122901|O2|Outcome|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
pharmacological study: Correlative studies"
648398|NCT01122901|O1|Outcome|Group A (Post Surgery) & Group B (Pre-surgery) RO4929097 PO|"GROUP A Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
pharmacological study: Correlative studies
GROUP B Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648412|NCT01122927|B1|Baseline|All Study Participants|Participants who entered open-label treatment phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
650454|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
648399|NCT01122901|O1|Outcome|Group B (Gamma-secretase Inhibitor RO4929097, Surgery)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648400|NCT01122901|O1|Outcome|Group B (Gamma-secretase Inhibitor RO4929097, Surgery)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648401|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648402|NCT01122901|O1|Outcome|Group A (Post Surgery) RO4929097 PO|"GROUP A Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
pharmacological study: Correlative studies
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648403|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648404|NCT01122901|O1|Outcome|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
pharmacological study: Correlative studies"
648405|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648406|NCT01122901|O1|Outcome|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
pharmacological study: Correlative studies"
648428|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648792|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.
Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
648407|NCT01122901|O1|Outcome|Group B (Gamma-secretase Inhibitor RO4929097, Surgery)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648408|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648409|NCT01122901|O1|Outcome|Group A (Post Surgery) & Group B (Pre-surgery) RO4929097 PO|"GROUP A Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
pharmacological study: Correlative studies
GROUP B Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648410|NCT01122901|E2|Reported Event|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies"
648411|NCT01122901|E1|Reported Event|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
pharmacological study: Correlative studies"
648808|NCT01117948|P1|Participant Flow|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
648413|NCT01122927|P2|Participant Flow|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648414|NCT01122927|P1|Participant Flow|Conversion Phase|Participants who entered this phase were converted from his or her antipsychotic to the minimum target dose of 10 mg/day aripiprazole monotherapy and continued to increase the dose up to a maximum of 30 mg/day, or for tolerability reasons, to reduce the aripiprazole dose to no less than 5 mg/day.
648415|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648416|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648417|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648418|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648419|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648420|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648421|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648422|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648423|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648424|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648425|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648426|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648427|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
649626|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
648429|NCT01122927|O5|Outcome|Tanner Score at Baseline of 5|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648430|NCT01122927|O4|Outcome|Tanner Score at Baseline of 4|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648431|NCT01122927|O3|Outcome|Tanner Score at Baseline of 3|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648432|NCT01122927|O2|Outcome|Tanner Score at Baseline of 2|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648433|NCT01122927|O1|Outcome|Tanner Score at Baseline of 1|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648434|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648435|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648436|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648437|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648438|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648439|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648440|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648441|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648442|NCT01122927|E2|Reported Event|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
648443|NCT01122927|E1|Reported Event|Conversion Phase|Participants who entered this phase were converted from his or her antipsychotic to the minimum target dose of 10 mg/day aripiprazole monotherapy and continue to increase the dose up to a maximum of 30 mg/day, or for tolerability reasons, to reduce the aripiprazole dose to no less than 5 mg/day.
648444|NCT01123148|B1|Baseline|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
648445|NCT01123148|P1|Participant Flow|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
648446|NCT01123148|O1|Outcome|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
648447|NCT01123148|E1|Reported Event|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
648448|NCT01123161|B3|Baseline|Total|Total of all reporting groups
648449|NCT01123161|B2|Baseline|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment
hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
648450|NCT01123161|B1|Baseline|Group1: IV t-PA and Normothermia|"IV tpa and normothermia
Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
648451|NCT01123161|P2|Participant Flow|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment
hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming."
648452|NCT01123161|P1|Participant Flow|Group1: IV t-PA and Normothermia|"IV tpa and normothermia
Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
648453|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment
hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
648454|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia
Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
648455|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia
hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering treatment includes buspirone, meperidine, and surface warming."
648456|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia
Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
648457|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment
hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming."
648458|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia
Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
648459|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment
hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
648460|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia
Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
648461|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment
hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
648462|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia
Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
648463|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment
hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
648464|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia
Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
648465|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia|"IV tpa and hypothermia
hypothermia: Hypothermia is induced using the Celsius Control™ System"
648466|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia
Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
648467|NCT01123161|E2|Reported Event|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment
hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming."
648468|NCT01123161|E1|Reported Event|Group1: IV t-PA and Normothermia|"IV tpa and normothermia
Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
648469|NCT01123200|B1|Baseline|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
648470|NCT01123200|P1|Participant Flow|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
648471|NCT01123200|O1|Outcome|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
648472|NCT01123200|O1|Outcome|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
648473|NCT01123200|E1|Reported Event|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
648474|NCT01123356|B1|Baseline|Oratumumab and Lenalidomide|"Single arm, non randomized study
Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.
Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
Treatment to be administered for up to 6 cycles"
648475|NCT01123356|P1|Participant Flow|Oratumumab and Lenalidomide|"Single arm, non randomized study
Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.
Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
Treatment to be administered for up to 6 cycles"
648476|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study
Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.
Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
Treatment to be administered for up to 6 cycles
Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)
-Treatment to be administered for up to 6 cycles
Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
648477|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study
Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.
Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
Treatment to be administered for up to 6 cycles
Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)
-Treatment to be administered for up to 6 cycles
Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
648478|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study
Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.
Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
Treatment to be administered for up to 6 cycles
Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)
-Treatment to be administered for up to 6 cycles
Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
648479|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study
Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.
Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
Treatment to be administered for up to 6 cycles
Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)
-Treatment to be administered for up to 6 cycles
Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
648480|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study
Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.
Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
Treatment to be administered for up to 6 cycles"
648481|NCT01123356|E1|Reported Event|Oratumumab and Lenalidomide|"Single arm, non randomized study
Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.
Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
Treatment to be administered for up to 6 cycles"
648482|NCT01123395|B1|Baseline|Colcrys® Intact Tab and Colcrys® Dissolved in Apple Juice|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
648483|NCT01123395|P2|Participant Flow|Colcrys® Dissolved in Apple Juice Then Colcrys® Intact Tab|On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and dissolved in 20 mL of apple juice after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours.
648484|NCT01123395|P1|Participant Flow|Colcrys® Intact Tab Then Colcrys® Dissolved in Apple Juice|On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and dissolved in 20 mL of apple juice, after an overnight fast of at least 10 hours
648485|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
648486|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
648487|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
648488|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
648489|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
648490|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
648491|NCT01123395|E2|Reported Event|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
648492|NCT01123395|E1|Reported Event|Colcrys® 0.6 mg Tablet Administered Intact|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
648493|NCT01123512|B3|Baseline|Total|Total of all reporting groups
648494|NCT01123512|B2|Baseline|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
648495|NCT01123512|B1|Baseline|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
648496|NCT01123512|P2|Participant Flow|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
648497|NCT01123512|P1|Participant Flow|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
648498|NCT01123512|O2|Outcome|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
648499|NCT01123512|O1|Outcome|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
648500|NCT01123512|E2|Reported Event|Balloon Kyphoplasty|Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
648501|NCT01123512|E1|Reported Event|Kiva VCF Treatment System|Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
648502|NCT01123642|B1|Baseline|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
648503|NCT01123642|P1|Participant Flow|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
648504|NCT01123642|O1|Outcome|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
648505|NCT01123642|E1|Reported Event|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
648506|NCT01123850|B1|Baseline|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.
Copios: Bone Void Filler"
648521|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space
corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
648507|NCT01123850|P1|Participant Flow|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.
Copios: Bone Void Filler"
648508|NCT01123850|O1|Outcome|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.
Copios: Bone Void Filler"
648509|NCT01123850|O1|Outcome|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.
Copios: Bone Void Filler"
648510|NCT01123850|E1|Reported Event|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.
Copios: Bone Void Filler"
648511|NCT01123889|B3|Baseline|Total|Total of all reporting groups
648512|NCT01123889|B2|Baseline|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space
platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
648809|NCT01117948|O2|Outcome|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
648513|NCT01123889|B1|Baseline|Control|"corticosteroid injection into subacromial space
corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
648514|NCT01123889|P2|Participant Flow|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space
platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
648515|NCT01123889|P1|Participant Flow|Control|"corticosteroid injection into subacromial space
corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
648516|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space
platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
648517|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space
corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
648518|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space
platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
648519|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space
corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
648520|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space
platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
650418|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
648522|NCT01123889|E2|Reported Event|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space
platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
648523|NCT01123889|E1|Reported Event|Control|"corticosteroid injection into subacromial space
corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
648524|NCT01117428|B7|Baseline|Total|Total of all reporting groups
648525|NCT01117428|B6|Baseline|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusions"
648526|NCT01117428|B5|Baseline|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 18 mg/kg, once every 2 weeks – i.v. infusions"
648527|NCT01117428|B4|Baseline|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 12 mg/kg, once every 2 weeks – i.v. infusions"
648528|NCT01117428|B3|Baseline|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg, weekly – i.v. infusions"
648529|NCT01117428|B2|Baseline|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 12 mg/kg, weekly – i.v. infusions"
648530|NCT01117428|B1|Baseline|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.
Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
648531|NCT01117428|P6|Participant Flow|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusions"
648810|NCT01117948|O1|Outcome|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
648532|NCT01117428|P5|Participant Flow|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 18 mg/kg, once every 2 weeks – i.v. infusions"
648533|NCT01117428|P4|Participant Flow|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 12 mg/kg, once every 2 weeks – i.v. infusions"
648534|NCT01117428|P3|Participant Flow|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg, weekly – i.v. infusions"
648535|NCT01117428|P2|Participant Flow|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-epidermal growth factor receptor (anti-EGFR) antibody refractory metastatic colorectal cancer (mCRC).
Sym004: 12 mg/kg, weekly – i.v. infusions"
648536|NCT01117428|P1|Participant Flow|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.
Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
648537|NCT01117428|O6|Outcome|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusion"
648538|NCT01117428|O5|Outcome|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 18 mg/kg, once every 2 weeks – i.v. infusions"
648539|NCT01117428|O4|Outcome|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 12 mg/kg, once every 2 weeks – i.v. infusions"
648540|NCT01117428|O3|Outcome|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg, weekly – i.v. infusions"
648541|NCT01117428|O2|Outcome|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 12 mg/kg, weekly – i.v. infusions"
648542|NCT01117428|O1|Outcome|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.
Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
648543|NCT01117428|O6|Outcome|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions"
648544|NCT01117428|O5|Outcome|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions"
648545|NCT01117428|O4|Outcome|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions"
648546|NCT01117428|O3|Outcome|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg, weekly - i.v. infusions"
648547|NCT01117428|O2|Outcome|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 12 mg/kg, weekly - i.v. infusions"
648548|NCT01117428|O1|Outcome|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.
Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions"
648549|NCT01117428|O6|Outcome|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusions"
648550|NCT01117428|O5|Outcome|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 18 mg/kg, once every 2 weeks – i.v. infusions"
648551|NCT01117428|O4|Outcome|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 12 mg/kg, once every 2 weeks – i.v. infusions"
648552|NCT01117428|O3|Outcome|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg weekly - i.v. infusions"
648553|NCT01117428|O2|Outcome|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 12 mg/kg, weekly – i.v. infusions"
648554|NCT01117428|O1|Outcome|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.
Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
648555|NCT01117428|O6|Outcome|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusions"
648556|NCT01117428|O5|Outcome|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 18 mg/kg, once every 2 weeks – i.v. infusions"
648557|NCT01117428|O4|Outcome|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 12 mg/kg, once every 2 weeks – i.v. infusions"
648558|NCT01117428|O3|Outcome|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 9 mg/kg, weekly – i.v. infusions"
648559|NCT01117428|O2|Outcome|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004: 12 mg/kg, weekly – i.v. infusions"
648560|NCT01117428|O1|Outcome|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.
Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
648561|NCT01117428|E6|Reported Event|Part F: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004 - 9 mg/kg loading dose followed by 6 mg/kg, weekly – i.v. infusions"
648562|NCT01117428|E5|Reported Event|Part E: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004 - 18 mg/kg, once every 2 weeks – i.v. infusions"
648563|NCT01117428|E4|Reported Event|Part D: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004 - 12 mg/kg, once every 2 weeks – i.v. infusions"
648564|NCT01117428|E3|Reported Event|Part C: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004 - 9 mg/kg, weekly – i.v. infusions"
648565|NCT01117428|E2|Reported Event|Part B: Dose Expansion Cohort|"Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC.
Sym004 - 12 mg/kg, weekly – i.v. infusions"
648566|NCT01117428|E1|Reported Event|Part A: Dose Escalation|"Dose escalation in patients with refractory or recurrent advanced solid tumors.
Sym004 - 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly – i.v. infusions"
648567|NCT01117454|B3|Baseline|Total|Total of all reporting groups
648568|NCT01117454|B2|Baseline|Placebo Then Flecainide|"In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy.
flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
648569|NCT01117454|B1|Baseline|Flecainide Then Placebo|"In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy.
flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
648570|NCT01117454|P2|Participant Flow|Placebo Then Flecainide|"In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy.
flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
648571|NCT01117454|P1|Participant Flow|Flecainide Then Placebo|"In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy.
flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
648572|NCT01117454|O2|Outcome|Placebo|All participants when receving placebo
648573|NCT01117454|O1|Outcome|Flecainide|All participants when receiving flecainide
648574|NCT01117454|E2|Reported Event|Placebo|All participants when receving placebo
648575|NCT01117454|E1|Reported Event|Flecainide|All participants when receiving flecainide
648576|NCT01117480|B1|Baseline|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
648577|NCT01117480|P1|Participant Flow|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
648578|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
648579|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
648580|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
648581|NCT01117480|E1|Reported Event|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
648582|NCT01117623|B9|Baseline|Total|Total of all reporting groups
648583|NCT01117623|B8|Baseline|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648584|NCT01117623|B7|Baseline|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648754|NCT01117766|B1|Baseline|All Participants|Includes all participants randomized to receive pregabalin first and placebo first.
648585|NCT01117623|B6|Baseline|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648586|NCT01117623|B5|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648587|NCT01117623|B4|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648588|NCT01117623|B3|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648589|NCT01117623|B2|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648590|NCT01117623|B1|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
650455|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
648591|NCT01117623|P8|Participant Flow|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648592|NCT01117623|P7|Participant Flow|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648593|NCT01117623|P6|Participant Flow|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648594|NCT01117623|P5|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 140 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648595|NCT01117623|P4|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 120 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648596|NCT01117623|P3|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648597|NCT01117623|P2|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648598|NCT01117623|P1|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral co-precipitate (CP) tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648599|NCT01117623|O2|Outcome|NSCLC Expansion Cohort, Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648760|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
648600|NCT01117623|O1|Outcome|HCC Expansion Cohort, Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A or B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648601|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648602|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648603|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648604|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648605|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
656904|NCT01147627|B4|Baseline|Total|Total of all reporting groups
648606|NCT01117623|O2|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648607|NCT01117623|O1|Outcome|HCC Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A or B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648608|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648609|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648610|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648611|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648612|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648613|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648614|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648615|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648616|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648617|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648618|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648619|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648620|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648770|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
656905|NCT01147627|B3|Baseline|Thiazolidinedione|
648621|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648622|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648623|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648624|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648625|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648626|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648627|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648628|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648629|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648630|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648755|NCT01117766|P2|Participant Flow|Placebo Then Pregabalin|Participants took placebo to match the pregabalin doses BID during the first 4- week treatment period. Then after a 2-week washout period, participants were titrated up to 300 mg pregabalin BID for the first 2 weeks and then remained at 300 mg BID for the duration of the second 4-week treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
648631|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648632|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648633|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648634|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648771|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
648772|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
648635|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648636|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648637|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648638|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648639|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648640|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648641|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648642|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648643|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648644|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648645|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648761|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
648793|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.
Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
648646|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648647|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648648|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648649|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648650|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648651|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648652|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648653|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648654|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648655|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648656|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648657|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648658|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648659|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648660|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648762|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
661289|NCT01151436|O1|Outcome|Hyaluronic Acid|
648661|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648662|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648663|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648664|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
656906|NCT01147627|B2|Baseline|Premixed Insulin Analog|
648665|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648666|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648667|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648668|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648669|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648670|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648671|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648672|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648673|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648674|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648675|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648763|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
648794|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.
Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
650419|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
648676|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648677|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648678|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648679|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
656907|NCT01147627|B1|Baseline|Exenatide|
648680|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648681|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648682|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648683|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648684|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648685|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648686|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648687|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648688|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648689|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648690|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648764|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
661290|NCT01151436|E1|Reported Event|Hyaluronic Acid|
648691|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648692|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648693|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648694|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648695|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648696|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648697|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648698|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648699|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648700|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648701|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648702|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648703|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648704|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648705|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648765|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
648795|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.
Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
648706|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648707|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648708|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648709|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648710|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648711|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648712|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648713|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648714|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648715|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648716|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648717|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648718|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648719|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648720|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648756|NCT01117766|P1|Participant Flow|Pregabalin Then Placebo|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg twice daily (BID) for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. Then after a 2-week washout period, participants took placebo to match the pregabalin doses BID during a 4-week treatment period.
648721|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648722|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648723|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648773|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
648811|NCT01117948|E2|Reported Event|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
650456|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
648724|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648725|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648726|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648727|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648728|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648729|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648730|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648731|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648732|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648733|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648734|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648735|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648757|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
648758|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
648736|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648737|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648774|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
648775|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
648738|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648739|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648740|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648741|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648742|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648743|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648744|NCT01117623|E5|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 140 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648745|NCT01117623|E4|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 120 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648746|NCT01117623|E3|Reported Event|Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle. This arm includes the participants from the dose escalation cohort: Regorafenib 100 mg and the three Expansion Cohorts 'HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg', 'HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg', 'NSCLC Expansion Cohort: Regorafenib 100 mg'.
648747|NCT01117623|E2|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648748|NCT01117623|E1|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
648749|NCT01117727|B1|Baseline|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
648750|NCT01117727|P1|Participant Flow|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
648751|NCT01117727|O2|Outcome|Pilot Testing With Scan Rate at 2 Stdev|Pilot testing with scan rate set at twice the standard deviation of the reaction time.
648752|NCT01117727|O1|Outcome|Pilot Testing, 0.65 Scan Rate|Pilot subject testing protocol with scan rate at 0.65 seconds per item.
648753|NCT01117727|E1|Reported Event|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
648766|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
648767|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
648768|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
648769|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
648805|NCT01117948|B2|Baseline|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
648776|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
648777|NCT01117766|E2|Reported Event|Placebo|Participants took placebo to match the pregabalin doses BID.
648778|NCT01117766|E1|Reported Event|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
648779|NCT01117857|B1|Baseline|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.
Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
648780|NCT01117857|P1|Participant Flow|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.
Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
648781|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.
Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
648782|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.
Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
648783|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.
Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
648784|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.
Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
648785|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.
Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
648786|NCT01117857|E1|Reported Event|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.
Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
648787|NCT01117870|B3|Baseline|Total|Total of all reporting groups
648788|NCT01117870|B2|Baseline|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.
Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
648789|NCT01117870|B1|Baseline|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.
Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
648790|NCT01117870|P2|Participant Flow|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.
Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
648791|NCT01117870|P1|Participant Flow|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.
Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
648860|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648796|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.
Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
648797|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.
Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
648798|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.
Pulsed RadioFrequency: 120 seconds at 42 degrees celsius
The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials."
648799|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.
Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.
The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials."
648800|NCT01117870|O1|Outcome|Lost to Follow-up Patients|Patients who were lost to follow-up at 3 months
648801|NCT01117870|O1|Outcome|Eligible Patients|Patients meeting eligibility criteria
648802|NCT01117870|E2|Reported Event|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.
Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
648803|NCT01117870|E1|Reported Event|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.
Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
648804|NCT01117948|B3|Baseline|Total|Total of all reporting groups
648812|NCT01117948|E1|Reported Event|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
648813|NCT01117987|B3|Baseline|Total|Total of all reporting groups
648814|NCT01117987|B2|Baseline|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648815|NCT01117987|B1|Baseline|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648816|NCT01117987|P2|Participant Flow|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648817|NCT01117987|P1|Participant Flow|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648818|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648819|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648820|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648821|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648822|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648823|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648824|NCT01117987|E2|Reported Event|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648825|NCT01117987|E1|Reported Event|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
648861|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648826|NCT01118013|B1|Baseline|Treatment|"Participants will receive:
Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
648827|NCT01118013|P1|Participant Flow|Treatment|"Participants will receive:
Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
648828|NCT01118013|O1|Outcome|Treatment|"Participants will receive:
Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
648829|NCT01118013|O1|Outcome|Treatment|"Participants will receive:
Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
648842|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
648830|NCT01118013|O1|Outcome|Treatment|"Participants will receive:
Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
648831|NCT01118013|O1|Outcome|Treatment|"Participants will receive:
Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
648832|NCT01118013|O1|Outcome|Treatment|"Participants will receive:
Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
648833|NCT01118013|E1|Reported Event|Treatment|"Participants will receive:
Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
648834|NCT01118091|B3|Baseline|Total|Total of all reporting groups
648835|NCT01118091|B2|Baseline|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
648836|NCT01118091|B1|Baseline|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
648837|NCT01118091|P2|Participant Flow|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
648862|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
650420|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
648838|NCT01118091|P1|Participant Flow|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
648839|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
648840|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
648841|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
648878|NCT01118143|E2|Reported Event|Control|The oral health instruction is according to standard clinical practice
657453|NCT01148771|B3|Baseline|Total|Total of all reporting groups
648843|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
648844|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
648845|NCT01118091|E2|Reported Event|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.
CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
648846|NCT01118091|E1|Reported Event|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
648847|NCT01118117|B3|Baseline|Total|Total of all reporting groups
648848|NCT01118117|B2|Baseline|Long Length (150mm) Misago™ Self-Expanding Stent System|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
648849|NCT01118117|B1|Baseline|Misago™ Self-Expanding Stent System|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648850|NCT01118117|P2|Participant Flow|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
648851|NCT01118117|P1|Participant Flow|Misago™ Self-Expanding Stent System|Subjects received treatment with the Misago™ Self-Expanding Stent
648852|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648853|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648854|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
648855|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648856|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
648857|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648858|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
648859|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648863|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
648864|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648865|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648866|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648867|NCT01118117|E2|Reported Event|Long Length Stent Sub-study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
648868|NCT01118117|E1|Reported Event|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
648869|NCT01118143|B3|Baseline|Total|Total of all reporting groups
648870|NCT01118143|B2|Baseline|Ordinary Oral Health Instruction|Oral health instruction commonly used in general practice
648871|NCT01118143|B1|Baseline|Individualized Oral Health Instruction|Individualized oral health instruction adapted to the patients oral health literacy level
648872|NCT01118143|P2|Participant Flow|Control: Short Standard Information|Participants in the control group got short standard information after the clinical measurement, as usual in general dental clinical practice. E.g. If there was gingival bleeding, participants got a message that their gums were bleeding and that dental floss was recommended.
648873|NCT01118143|P1|Participant Flow|Experiment: Communication Adapted to Health Literacy Level|Participants in the experimental group got individualized communication regarding their oral health. The communication was adapted to the measured Health Literacy level of each participant. Health Literacy communication theory was utilized in order to adapt the communication to the participants Health literacy level. Two-way communication with use of models, illustrative pictures and teach-back method was emphasized. Up to 30 minutes was available for this intervention conversation.
648874|NCT01118143|O2|Outcome|Ordinary Oral Health Instruction|The effect of intervention is evaluated using measures of plaque index
648875|NCT01118143|O1|Outcome|Individualized Oral Health Instruction|The effect of intervention is evaluated using measures of plaque index
648876|NCT01118143|O2|Outcome|Ordinary Oral Health Instruction|Oral health instruction commonly used in general practice
648877|NCT01118143|O1|Outcome|Individualized Oral Health Instruction|Individualized oral health instruction adapted to the patients oral health literacy level
648879|NCT01118143|E1|Reported Event|Individualized Oral Health Instruction|The oral health instruction is individualized according to the patients oral health literacy level
648880|NCT01118221|B3|Baseline|Total|Total of all reporting groups
648881|NCT01118221|B2|Baseline|Control|no structured exercise
648882|NCT01118221|B1|Baseline|Pulmonary Rehabilitation|"enroll in pulmonary rehabilitation program
pulmonary rehabilitation: structured exercise program"
648883|NCT01118221|P2|Participant Flow|Control|no structured exercise
648884|NCT01118221|P1|Participant Flow|Pulmonary Rehabilitation|"enroll in pulmonary rehabilitation program
pulmonary rehabilitation: structured exercise program"
648885|NCT01118221|O2|Outcome|Control Group|no structured exercise
648886|NCT01118221|O1|Outcome|Rehabilitation Group|"enroll in pulmonary rehabilitation program
pulmonary rehabilitation: structured exercise program"
648887|NCT01118221|O2|Outcome|After Exercise Testing|Plasma isoprostanes after exercise testing.
648888|NCT01118221|O1|Outcome|Before Exercise Testing|Plasma isoprostanes before exercise test.
648889|NCT01118221|O2|Outcome|Arm 2|no structured exercise
648890|NCT01118221|O1|Outcome|Arm 1|"enroll in pulmonary rehabilitation program
pulmonary rehabilitation: structured exercise program"
648891|NCT01118221|E2|Reported Event|Arm 2|no structured exercise
648892|NCT01118221|E1|Reported Event|Arm 1|"enroll in pulmonary rehabilitation program
pulmonary rehabilitation: structured exercise program"
648893|NCT01118273|B7|Baseline|Total|Total of all reporting groups
648894|NCT01118273|B6|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648895|NCT01118273|B5|Baseline|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648896|NCT01118273|B4|Baseline|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648897|NCT01118273|B3|Baseline|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648898|NCT01118273|B2|Baseline|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648899|NCT01118273|B1|Baseline|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648900|NCT01118273|P6|Participant Flow|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648901|NCT01118273|P5|Participant Flow|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648902|NCT01118273|P4|Participant Flow|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648903|NCT01118273|P3|Participant Flow|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648904|NCT01118273|P2|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648905|NCT01118273|P1|Participant Flow|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648906|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648907|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648908|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648909|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648910|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648911|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648912|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648913|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648914|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648915|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648916|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648917|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648918|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648919|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648920|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648921|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648922|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648923|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648924|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648925|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648926|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648927|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648928|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648929|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648930|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648931|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648932|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648933|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648934|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648935|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648936|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648937|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648938|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648939|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648940|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648941|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
661674|NCT01159665|B7|Baseline|Total|Total of all reporting groups
648942|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648943|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648944|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648945|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648946|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648947|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648948|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648949|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648950|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648951|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648952|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648953|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648954|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648955|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648956|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648957|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648958|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648959|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648960|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648961|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648962|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648963|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648964|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648965|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648966|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648967|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648968|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648969|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648970|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648971|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648972|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648973|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648974|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648975|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648976|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648977|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
662248|NCT01161563|E1|Reported Event|Leuprolide Acetate|
648978|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648979|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648980|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648981|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648982|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648983|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648984|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648985|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648986|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648987|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648988|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648989|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648990|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648991|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648992|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648993|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
648994|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
648995|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
648996|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
648997|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
648998|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
648999|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649000|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649001|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
649002|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
649003|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
649004|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
649005|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649006|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649007|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
649008|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
649009|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
649010|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
649011|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649012|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649013|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
666855|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
649014|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
649015|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
649016|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
649017|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649018|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649019|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
649020|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
649021|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
649022|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
649023|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649024|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649025|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
649026|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
649027|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
649028|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
649029|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649030|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649031|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
649032|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
649033|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
649034|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
649035|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649036|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649037|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
649038|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
649039|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
649040|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
649041|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649042|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649043|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
649044|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
649045|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
649046|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
649047|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649048|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649049|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
666856|NCT01174446|O5|Outcome|On-Demand: End of Study|
649050|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
649051|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
649052|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
649053|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649054|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649055|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
649056|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
649057|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
649058|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
649059|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649060|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649061|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
649062|NCT01118273|E6|Reported Event|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
649063|NCT01118273|E5|Reported Event|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
649156|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
649064|NCT01118273|E4|Reported Event|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
649065|NCT01118273|E3|Reported Event|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
649066|NCT01118273|E2|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
649067|NCT01118273|E1|Reported Event|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
649068|NCT01118312|B3|Baseline|Total|Total of all reporting groups
649069|NCT01118312|B2|Baseline|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray"
649070|NCT01118312|B1|Baseline|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
649071|NCT01118312|P2|Participant Flow|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray"
649072|NCT01118312|P1|Participant Flow|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
649073|NCT01118312|O2|Outcome|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray"
649074|NCT01118312|O1|Outcome|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
649075|NCT01118312|O2|Outcome|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray"
649076|NCT01118312|O1|Outcome|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
649077|NCT01118312|E2|Reported Event|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray"
649078|NCT01118312|E1|Reported Event|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
649079|NCT01123928|B3|Baseline|Total|Total of all reporting groups
649080|NCT01123928|B2|Baseline|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
649081|NCT01123928|B1|Baseline|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
649082|NCT01123928|P2|Participant Flow|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
649083|NCT01123928|P1|Participant Flow|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
649265|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
649084|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
649085|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
649086|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
649087|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
649088|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
649089|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
649090|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
649091|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
649092|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
649093|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
649094|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
649095|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
649096|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
649097|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
649098|NCT01123928|E2|Reported Event|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
649099|NCT01123928|E1|Reported Event|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
649100|NCT01123941|B3|Baseline|Total|Total of all reporting groups
649101|NCT01123941|B2|Baseline|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
649102|NCT01123941|B1|Baseline|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
649103|NCT01123941|P2|Participant Flow|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
649104|NCT01123941|P1|Participant Flow|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
649105|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
649106|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
649107|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
649108|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
649109|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
649110|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
649111|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
649112|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
649113|NCT01123941|E2|Reported Event|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
649114|NCT01123941|E1|Reported Event|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
649115|NCT01123980|B3|Baseline|Total|Total of all reporting groups
649116|NCT01123980|B2|Baseline|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649117|NCT01123980|B1|Baseline|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649118|NCT01123980|P2|Participant Flow|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649119|NCT01123980|P1|Participant Flow|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649120|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649121|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649266|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
649122|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649123|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649124|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649125|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649126|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649127|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649128|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649129|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649130|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649131|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649200|NCT01124097|B5|Baseline|Total|Total of all reporting groups
649201|NCT01124097|B4|Baseline|Placebo|Placebo: Tablets will be used.
649132|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649133|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649134|NCT01123980|E2|Reported Event|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649135|NCT01123980|E1|Reported Event|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
649136|NCT01124006|B4|Baseline|Total|Total of all reporting groups
649137|NCT01124006|B3|Baseline|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649138|NCT01124006|B2|Baseline|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
649139|NCT01124006|B1|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649140|NCT01124006|P3|Participant Flow|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649141|NCT01124006|P2|Participant Flow|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
649142|NCT01124006|P1|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649143|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649144|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
649145|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649146|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649147|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
667019|NCT01175018|B3|Baseline|Total|Total of all reporting groups
649148|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649149|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649150|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
649151|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649152|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649153|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
649154|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649155|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649157|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649158|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649159|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
649160|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649161|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649162|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
649163|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649164|NCT01124006|E3|Reported Event|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649165|NCT01124006|E2|Reported Event|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
649166|NCT01124006|E1|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
649167|NCT01124045|B3|Baseline|Total|Total of all reporting groups
649168|NCT01124045|B2|Baseline|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649169|NCT01124045|B1|Baseline|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649170|NCT01124045|P2|Participant Flow|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649267|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
649171|NCT01124045|P1|Participant Flow|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649172|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649173|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649174|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649175|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649176|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649177|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649178|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649202|NCT01124097|B3|Baseline|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
649179|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649180|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649181|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649182|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649183|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649184|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649185|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649186|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649187|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649188|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649189|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649190|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649191|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649268|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
649269|NCT01124175|E2|Reported Event|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
649192|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649193|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649194|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649195|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649196|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649197|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649198|NCT01124045|E2|Reported Event|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649199|NCT01124045|E1|Reported Event|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
649204|NCT01124097|B1|Baseline|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
649205|NCT01124097|P4|Participant Flow|Placebo|Placebo: Tablets will be used.
649206|NCT01124097|P3|Participant Flow|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
649207|NCT01124097|P2|Participant Flow|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
649208|NCT01124097|P1|Participant Flow|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
649209|NCT01124097|O4|Outcome|Placebo|Placebo: Tablets will be used.
649210|NCT01124097|O3|Outcome|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
649211|NCT01124097|O2|Outcome|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
649212|NCT01124097|O1|Outcome|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
649213|NCT01124097|E4|Reported Event|Placebo|Placebo: Tablets will be used.
649214|NCT01124097|E3|Reported Event|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
649215|NCT01124097|E2|Reported Event|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
649216|NCT01124097|E1|Reported Event|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
649217|NCT01124149|B1|Baseline|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
649218|NCT01124149|P1|Participant Flow|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
649219|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
649220|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
649221|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
649222|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
649223|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
649224|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
649225|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
649270|NCT01124175|E1|Reported Event|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
649271|NCT01124188|B3|Baseline|Total|Total of all reporting groups
650211|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
649226|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
649227|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
649228|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
649229|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
649230|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
649231|NCT01124149|E2|Reported Event|MMX Mesalamine/ Mesalazine (Maintenance Phase)|2.4 g/day given QD for 12 months in the Maintenance Phase
649232|NCT01124149|E1|Reported Event|MMX Mesalamine/ Mesalazine (Acute Phase)|4.8g/day given QD for 8 weeks in the Acute Phase
649233|NCT01124162|B3|Baseline|Total|Total of all reporting groups
649234|NCT01124162|B2|Baseline|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
657727|NCT01143259|B3|Baseline|Total|Total of all reporting groups
649235|NCT01124162|B1|Baseline|Losartan (Test) First|100 mg Losartan Tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
649236|NCT01124162|P2|Participant Flow|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
649237|NCT01124162|P1|Participant Flow|Losartan (Test) First|100 mg Losartan Tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
649238|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
649239|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
649240|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
649241|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
649242|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
649243|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
649244|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
649245|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
649246|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
649247|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
649248|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
649249|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
649250|NCT01124162|E2|Reported Event|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
649251|NCT01124162|E1|Reported Event|Losartan|100 mg Losartan Tablets test product dosed in either period.
649252|NCT01124175|B3|Baseline|Total|Total of all reporting groups
649253|NCT01124175|B2|Baseline|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
649254|NCT01124175|B1|Baseline|Losartan (Test) First|100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
649255|NCT01124175|P2|Participant Flow|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
649256|NCT01124175|P1|Participant Flow|Losartan (Test) First|100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
649257|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
649258|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
649259|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
649260|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
649261|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
649262|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
649263|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
649264|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
667020|NCT01175018|B2|Baseline|Placebo|0.67 ml of NaCl 0.9% solution
649272|NCT01124188|B2|Baseline|Active Control|"Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
649273|NCT01124188|B1|Baseline|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
649274|NCT01124188|P2|Participant Flow|Active Control|"Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
649275|NCT01124188|P1|Participant Flow|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
649276|NCT01124188|O2|Outcome|Active Control|"Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
649277|NCT01124188|O1|Outcome|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
649278|NCT01124188|O2|Outcome|Active Control|"Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
649299|NCT01127139|O3|Outcome|Male Participants|Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
650457|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
649279|NCT01124188|O1|Outcome|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
649280|NCT01124188|O2|Outcome|Active Control|"Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
649281|NCT01124188|O1|Outcome|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
649282|NCT01124188|E2|Reported Event|Active Control|"Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
649283|NCT01124188|E1|Reported Event|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
649284|NCT01127087|B3|Baseline|Total|Total of all reporting groups
649285|NCT01127087|B2|Baseline|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
649286|NCT01127087|B1|Baseline|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
649287|NCT01127087|P2|Participant Flow|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.
Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
649288|NCT01127087|P1|Participant Flow|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).
Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
649289|NCT01127087|O2|Outcome|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.
Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
649290|NCT01127087|O1|Outcome|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).
Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
649324|NCT01127165|E1|Reported Event|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
649291|NCT01127087|O2|Outcome|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
649292|NCT01127087|O1|Outcome|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
649293|NCT01127087|E2|Reported Event|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
649294|NCT01127087|E1|Reported Event|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).
Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
649295|NCT01127139|B1|Baseline|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
649296|NCT01127139|P1|Participant Flow|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
649297|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
649298|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
649300|NCT01127139|O2|Outcome|Female Participants|Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
649301|NCT01127139|O1|Outcome|Total|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
649302|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
649303|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
649304|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
649305|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
649306|NCT01127139|O3|Outcome|Male Participants|Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
649307|NCT01127139|O2|Outcome|Female Participants|Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
649308|NCT01127139|O1|Outcome|Total|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
649309|NCT01127139|E1|Reported Event|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
649310|NCT01127165|B3|Baseline|Total|Total of all reporting groups
649311|NCT01127165|B2|Baseline|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
649312|NCT01127165|B1|Baseline|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
649313|NCT01127165|P2|Participant Flow|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
649314|NCT01127165|P1|Participant Flow|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
649315|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
649316|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
649317|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
649318|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
649319|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
649320|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
649321|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
649322|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
649323|NCT01127165|E2|Reported Event|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
649326|NCT01127256|B2|Baseline|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
649327|NCT01127256|B1|Baseline|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
649328|NCT01127256|P2|Participant Flow|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
649329|NCT01127256|P1|Participant Flow|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
649330|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
649331|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
649332|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
649333|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
649334|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
649335|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
649336|NCT01127256|E2|Reported Event|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
649337|NCT01127256|E1|Reported Event|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
649338|NCT01127321|B6|Baseline|Total|Total of all reporting groups
649339|NCT01127321|B5|Baseline|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
649340|NCT01127321|B4|Baseline|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
649341|NCT01127321|B3|Baseline|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
649342|NCT01127321|B2|Baseline|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
649343|NCT01127321|B1|Baseline|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
649344|NCT01127321|P5|Participant Flow|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
649345|NCT01127321|P4|Participant Flow|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
649346|NCT01127321|P3|Participant Flow|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
649347|NCT01127321|P2|Participant Flow|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
649348|NCT01127321|P1|Participant Flow|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
649349|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
649350|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
649351|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
649352|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
649353|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
649354|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
649355|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
649356|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
649357|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
649358|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
649359|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
649360|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
649361|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
649362|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
649363|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
649364|NCT01127321|E5|Reported Event|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
649365|NCT01127321|E4|Reported Event|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
649366|NCT01127321|E3|Reported Event|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
649367|NCT01127321|E2|Reported Event|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
649368|NCT01127321|E1|Reported Event|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
649369|NCT01127438|B7|Baseline|Total|Total of all reporting groups
649370|NCT01127438|B6|Baseline|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649371|NCT01127438|B5|Baseline|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649372|NCT01127438|B4|Baseline|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
649373|NCT01127438|B3|Baseline|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649374|NCT01127438|B2|Baseline|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
649375|NCT01127438|B1|Baseline|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649376|NCT01127438|P6|Participant Flow|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day).
649377|NCT01127438|P5|Participant Flow|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 3.9mg of Lusedra per kg during the Randomization Phase (1 day).
649378|NCT01127438|P4|Participant Flow|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomization Phase (1 day).
649379|NCT01127438|P3|Participant Flow|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day).
649380|NCT01127438|P2|Participant Flow|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomization Phase (1 day).
650458|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
649381|NCT01127438|P1|Participant Flow|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. The doses were weight-adjusted for each subject, with 6.5mg of Lusedra per kg during the Randomization Phase (1 day).
649382|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649383|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649384|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
649385|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649386|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
649387|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649388|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649389|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649390|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
649391|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649392|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
649454|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649455|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
649393|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649394|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649395|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649396|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
649397|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649398|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
649399|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
649400|NCT01127438|E2|Reported Event|Approved Dose|Includes subgroups 1-3
649401|NCT01127438|E1|Reported Event|Lower Dose|Includes subgroups 1-3
649402|NCT01127581|B3|Baseline|Total|Total of all reporting groups
650459|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
649403|NCT01127581|B2|Baseline|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649404|NCT01127581|B1|Baseline|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649405|NCT01127581|P2|Participant Flow|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649406|NCT01127581|P1|Participant Flow|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649407|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649408|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649409|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649410|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649411|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649412|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649456|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649413|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649414|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649415|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649416|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649417|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649418|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649544|NCT01127659|B3|Baseline|Obese With HH: Placebo|"placebo obese hypogonadal arm
placebo: saline intramuscular every 2 weeks"
649419|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649420|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649421|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649422|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649423|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649424|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649425|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649426|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649427|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649428|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649457|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
649458|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649429|NCT01127581|E2|Reported Event|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert
Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649430|NCT01127581|E1|Reported Event|MVI 200|"MVI 200 mcg vaginal insert
MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
649431|NCT01127607|B3|Baseline|Total|Total of all reporting groups
649432|NCT01127607|B2|Baseline|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
649433|NCT01127607|B1|Baseline|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
649434|NCT01127607|P2|Participant Flow|Treatment Arm|All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period I). The 13 subjects assigned to this arm were then switched to blinded optimal dose of LDX for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only their optimal dose of LDX during period II.
649435|NCT01127607|P1|Participant Flow|Placebo Arm|All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period 1). The 14 subjects assigned to this arm were then switched to blinded placebo for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only placebo during period II.
649436|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
649437|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
649438|NCT01127607|O4|Outcome|70 mg Lisdexamfetamine|This group includes all participants who were prescribed the 70mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg and 50mg doses and are therefore included in those groups as well. Not all participants who were prescribed this dose were optimized to this dose.
649439|NCT01127607|O3|Outcome|50 mg Lisdexamfetamine|This group includes all participants who were prescribed the 50mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg dose and are therefore included in that group as well.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study.
649440|NCT01127607|O2|Outcome|30 mg Lisdexamfetamine|This arm includes all participants who were prescribed the 30mg dose and completed at least one side effect rating for this dose.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study which is why this cell size is larger than for the randomized controlled comparison that followed it.
649441|NCT01127607|O1|Outcome|No Medication|The PSERS was completed at intake by all 38 participants who consented and met eligibility criteria in order to assess pre-medication rates of side effects. This was done because the PSERS measures commonly occurring events such as insomnia and irritability that can be seen in unmedicated patients with ADHD.
649442|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649443|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
649444|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649445|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649446|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649447|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649448|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649449|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649450|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649451|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649452|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
667156|NCT01175369|B1|Baseline|Usual Care|Usual asthma care
649460|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649461|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
649462|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
649463|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
649464|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649465|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
649466|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649467|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
649468|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649469|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
649470|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649471|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
649472|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
649473|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
649545|NCT01127659|B2|Baseline|Obese With HH: Testosterone|"active drug obese hypogonadal arm
testosterone: intramuscular every 2 weeks"
649474|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
649475|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
649476|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649477|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
649478|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649479|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
649480|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
649481|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
649482|NCT01127607|O2|Outcome|Optimal Dose of Medication|Optimal dose of lisdexamfetamine (30 mg, 50 mg, or 70 mg) as selected by a three week open medication titration trial.
649483|NCT01127607|O1|Outcome|Unmedicated|baseline; participants not on medication
649484|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649485|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649486|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649487|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649488|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649489|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649490|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649491|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
649492|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
649493|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
649494|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
649495|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
649496|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
649497|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
649498|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
649499|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
649500|NCT01127607|E5|Reported Event|All Participants in Period 1 Prescribed 70mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.
17 of 36 participants were dispensed the 70mg dose."
649501|NCT01127607|E4|Reported Event|All Participants in Period 1 Prescribed 50mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.
21 of 36 participants were dispensed the 50mg dose."
649502|NCT01127607|E3|Reported Event|All Participants in Period 1 Prescribed 30mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.
All 36 participants who were dispensed the 30mg dose and completed at least one Pittsburgh Side Effect Rating Scale (PSERS) are included in this category."
649503|NCT01127607|E2|Reported Event|Treatment Arm|subjects in this arm (N=13) only treated with blinded optimal dose of LDX (either 30mg, 50mg or 70mg) for duration of assessment (period II between subjects trial).
649549|NCT01127659|P4|Participant Flow|Obese Placebo|"placebo obese arm
placebo: saline intramuscular every 2 weeks"
649504|NCT01127607|E1|Reported Event|Placebo Arm|subjects in this arm treated only with blinded placebo for duration of assessment (period II- between subjects trial).One participant assigned to placebo dropped out before medication was dispensed for period II which is why the side effect data only has a total of 13 and not 14 subjects.
649505|NCT01127646|B3|Baseline|Total|Total of all reporting groups
649506|NCT01127646|B2|Baseline|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649507|NCT01127646|B1|Baseline|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649508|NCT01127646|P2|Participant Flow|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649509|NCT01127646|P1|Participant Flow|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649510|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
649511|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
649512|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
649513|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
649514|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649515|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649516|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
650081|NCT01129102|E2|Reported Event|IKH-01|"Norethisterone 1mg, Ethinyl estradiol 0.035mg
IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg"
649517|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649518|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649519|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649520|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649521|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649522|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649546|NCT01127659|B1|Baseline|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm
testosterone: intramuscular every 2 weeks"
649523|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649524|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
649525|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
649526|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649527|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649528|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649529|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649530|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649531|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649532|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649533|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649534|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649535|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649536|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649537|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
649538|NCT01127646|E2|Reported Event|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
649539|NCT01127646|E1|Reported Event|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 25-80 mg of atomoxetine orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
649540|NCT01127659|B7|Baseline|Total|Total of all reporting groups
649541|NCT01127659|B6|Baseline|Eugonadal Obese|obese non-diabetic men with normal testosterone
649542|NCT01127659|B5|Baseline|Eugonadal Diabetes|diabetic men with normal testosterone
649543|NCT01127659|B4|Baseline|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm
placebo: saline intramuscular every 2 weeks"
649547|NCT01127659|P6|Participant Flow|Eugonadal Obese|no intervention
649550|NCT01127659|P3|Participant Flow|Obese Testosterone|"active drug obese arm
testosterone: intramuscular every 2 weeks"
649551|NCT01127659|P2|Participant Flow|Diabetes With HH: Placebo|"placebo diabetes arm
placebo: saline intramuscular every 2 weeks"
649552|NCT01127659|P1|Participant Flow|Diabetes With HH: Testosterone|"active drug diabetes arm
testosterone: intramuscular every 2 weeks"
649553|NCT01127659|O6|Outcome|Eugonadal Obese|obese non-diabetic men with normal testosterone
649554|NCT01127659|O5|Outcome|Eugonadal Diabetes|"diabetic men with normal testosterone
Glucose infusion rate: 10.29+/-5.55 mg/kg fat-free mass/min"
649555|NCT01127659|O4|Outcome|Obese With HH: Placebo|"placebo obese hypogonadal arm
placebo: saline intramuscular every 2 weeks"
649556|NCT01127659|O3|Outcome|Obese With HH: Testosterone|"active drug obese hypogonadal arm
testosterone: intramuscular every 2 weeks"
649557|NCT01127659|O2|Outcome|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm
placebo: saline intramuscular every 2 weeks"
649558|NCT01127659|O1|Outcome|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm
testosterone: intramuscular every 2 weeks
Glucose infusion rate: 6.5+/-4.0 mg/kg fat-free mass/min"
649559|NCT01127659|E6|Reported Event|Eugonadal Obese|obese non-diabetic men with normal testosterone
649560|NCT01127659|E5|Reported Event|Eugonadal Diabetes|diabetic men with normal testosterone
649561|NCT01127659|E4|Reported Event|Obese With HH: Placebo|"placebo obese hypogonadal arm
placebo: saline intramuscular every 2 weeks"
649562|NCT01127659|E3|Reported Event|Obese With HH: Testosterone|"active drug obese hypogonadal arm
testosterone: intramuscular every 2 weeks"
649563|NCT01127659|E2|Reported Event|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm
placebo: saline intramuscular every 2 weeks"
649564|NCT01127659|E1|Reported Event|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm
testosterone: intramuscular every 2 weeks"
649565|NCT01127737|B3|Baseline|Total|Total of all reporting groups
649566|NCT01127737|B2|Baseline|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
649567|NCT01127737|B1|Baseline|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
649568|NCT01127737|P2|Participant Flow|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
649569|NCT01127737|P1|Participant Flow|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
649570|NCT01127737|O2|Outcome|Placebo|
649571|NCT01127737|O1|Outcome|Intervention|Educational intervention consisting of a mnemonic and a workboook
649572|NCT01127737|E2|Reported Event|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
649573|NCT01127737|E1|Reported Event|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
649574|NCT01127763|B1|Baseline|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
649575|NCT01127763|P1|Participant Flow|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
649576|NCT01127763|O1|Outcome|RAD001+Carboplatin (All Patients)|Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
649625|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
649577|NCT01127763|O1|Outcome|RAD001+Carboplatin|"Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
RAD001
Carboplatin"
649578|NCT01127763|O3|Outcome|RAD001+Carboplatin (All Patients)|Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
649579|NCT01127763|O2|Outcome|RAD001+Carboplatin (AUC 4)|Carboplatin (starting dose of AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
649580|NCT01127763|O1|Outcome|RAD001+Carboplatin (AUC 6 and 5)|Carboplatin (starting dose of AUC 6 or AUC 5) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
649581|NCT01127763|O1|Outcome|RAD001+Carboplatin|"Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
RAD001
Carboplatin"
649582|NCT01127763|E1|Reported Event|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
649583|NCT01128049|B4|Baseline|Total|Total of all reporting groups
649584|NCT01128049|B3|Baseline|ADDE Population|Subjects with schirmer’s value < 10mm/5 mins and no meibomian gland dysfunction.
649585|NCT01128049|B2|Baseline|MGD Patient Population|Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs.
649586|NCT01128049|B1|Baseline|Normal Patient Population|Subjects with no symptoms and no diagnosis of dry eye. Schirmer’s value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining.
649587|NCT01128049|P3|Participant Flow|ADDE Population|Subjects with schirmer’s value < 10mm/5 mins and no meibomian gland dysfunction.
649588|NCT01128049|P2|Participant Flow|MGD Patient Population|Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs.
649589|NCT01128049|P1|Participant Flow|Normal Patient Population|Subjects with no symptoms and no diagnosis of dry eye. Schirmer’s value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining.
649590|NCT01128049|O3|Outcome|Aqueous Deficiency Dry Eye (ADDE)|Subjects with a low tear volume measured by Schimer's score of less than 10 mm were included in this group.
649735|NCT01128400|P2|Participant Flow|rs1761667-GG Genotype|subjects who are homozygous of CD36 genotype rs1761667-G allele.
649591|NCT01128049|O2|Outcome|Meibomian Gland Dysfunction (MGD)|Subjects with mild to moderate Meibomian Gland Dysfunction (MGD) on a slit lamp examination were included in this group.
649592|NCT01128049|O1|Outcome|Normal|Normal group included non-dry eye subjects.
649593|NCT01128049|E3|Reported Event|ADDE Population|Aqueous Deficient Dry Eye population(intervention remains the same across all arms)
649594|NCT01128049|E2|Reported Event|MGD Patient Population|Meibomium Gland Dysfunction population(intervention remains the same across all arms)
649595|NCT01128049|E1|Reported Event|Normal Patient Population|Non-Dry Eye patient population (intervention remains the same across all arms)
649596|NCT01128114|B1|Baseline|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
649597|NCT01128114|P1|Participant Flow|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
649598|NCT01128114|O1|Outcome|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
649599|NCT01128114|E1|Reported Event|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
649600|NCT01128153|B3|Baseline|Total|Total of all reporting groups
649601|NCT01128153|B2|Baseline|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
649602|NCT01128153|B1|Baseline|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
649603|NCT01128153|P2|Participant Flow|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
649604|NCT01128153|P1|Participant Flow|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
649605|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
649606|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
649607|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
649608|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
649609|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
649610|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
649611|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
649612|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
649613|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
649614|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
649615|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
649616|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
649617|NCT01128153|E2|Reported Event|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
649618|NCT01128153|E1|Reported Event|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
649619|NCT01128179|B3|Baseline|Total|Total of all reporting groups
649620|NCT01128179|B2|Baseline|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
649621|NCT01128179|B1|Baseline|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
649622|NCT01128179|P2|Participant Flow|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
649623|NCT01128179|P1|Participant Flow|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
649627|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
649628|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
649629|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
649630|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
649631|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
649632|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
649633|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
649634|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
649635|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
649636|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
649637|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
649638|NCT01128179|E2|Reported Event|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
649639|NCT01128179|E1|Reported Event|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
649640|NCT01128192|B3|Baseline|Total|Total of all reporting groups
649641|NCT01128192|B2|Baseline|Pasireotide 900 μg sc Bid|Pasireotide 900 μg sc bid n=19
649642|NCT01128192|B1|Baseline|Pasireotide 600 μg sc Bid|Pasireotide 600 μg sc bid n=19
649643|NCT01128192|P3|Participant Flow|Pasireotide 1200 μg sc Bid|7 healthy male volunteers were randomized to receive Pasireotide 1200 μg (n=7). This arm was used in safety analysis only.
649741|NCT01128400|O2|Outcome|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
649644|NCT01128192|P2|Participant Flow|Pasireotide 900 μg sc Bid|19 healthy male volunteers were randomized to receive Pasireotide 900 μg (n=19). All participants completed the study.
649645|NCT01128192|P1|Participant Flow|Pasireotide 600 μg sc Bid|19 healthy male volunteers were randomized to receive Pasireotide 600 μg (n=19). All participants completed the study.
649646|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
649647|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
649648|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
649649|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
649650|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
649651|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
649652|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
649653|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
649654|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
649655|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
649656|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
649657|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
649658|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
649659|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
649660|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
649661|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
649662|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
649663|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
649664|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
649665|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
649666|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
649667|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
649668|NCT01128192|E3|Reported Event|Pasireotide 1200 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
649669|NCT01128192|E2|Reported Event|Pasireotide 900 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
649670|NCT01128192|E1|Reported Event|Pasireotide 600 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
649671|NCT01128244|B1|Baseline|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
Vitamin B6: Subjects will receive vitamin B6 supplementation.
Infusion of amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
649672|NCT01128244|P1|Participant Flow|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
Vitamin B6: Subjects will receive vitamin B6 supplementation.
Infusion of the amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
649673|NCT01128244|O1|Outcome|Secondary Analysis: Plasma 3-hydroxykynurenine Concentration|Plasma 3-hydroxykynurenine concentration will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
649674|NCT01128244|O1|Outcome|Plasma Cystathionine Concentration|Plasma cystathionine will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
649675|NCT01128244|O1|Outcome|Plasma Pyridoxal Phosphate Concentration|Plasma PLP will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
649676|NCT01128244|O1|Outcome|Homocysteine Remethylation Flux From Serine|All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
649677|NCT01128244|O1|Outcome|Total Homocysteine Remethylation Flux|All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
649678|NCT01128244|E1|Reported Event|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
Vitamin B6: Subjects will receive vitamin B6 supplementation.
Infusion of amino acids, serine, and methionine: Subjects will be given an infusion of the amino acids, serine, and methionine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
649679|NCT01128270|B1|Baseline|All Subjects|Intent was to have all subjects participate in all sessions (periods)
649680|NCT01128270|P1|Participant Flow|All Subjects|The intent was to have all subjects participate in all four sessions (periods). These were environmental chloral hydrate +/- environmental DCA and therapeutic chloral hydrate +/- therapeutic DCA. Patient participation: 4 Sessions (N=2), 3 Sessions (N=1), 2 Sessions (N=6), 1 Session (N=8), 0 Sessions (N=10), Total: N=27 patients participated in 31 sessions.
649681|NCT01128270|O4|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
649682|NCT01128270|O3|Outcome|Therapeutic Chloral Hydrate and DCA (2A)|Arm 2A: Subjects are given Chloral Hydrate (25 mg/kg for five nights) and therapeutic Dichloroacetate on Day 1 (25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
649683|NCT01128270|O2|Outcome|Environmental Chloral Hydrate (1B)|Arm 1B: Subjects are given Chloral Hydrate (1.5mcg/kg for five nights). Pharmacokinetics are done on days 1 and 5.
649684|NCT01128270|O1|Outcome|Environmental Chloral Hydrate and DCA (1A)|Arm 1A: Subjects are given Chloral Hydrate (1.5mcg/kg for five nights) and environmental Dichloroacetate on Day 1 (2.5 mcg/Kg.)pharmacokinetics are done on days 1 and 5.
649685|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
649686|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
649687|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate and DCA (2A)|Arm 2A: Subjects are given Chloral Hydrate (25 mg/kg for five nights) and therapeutic Dichloroacetate on Day 1 (25 mg/Kg.) Pharmacokinetics are done on days 1 and 5. This outcome only applies to Period 3.
649688|NCT01128270|E4|Reported Event|Chloral Hydrate (Therapeutic Dose)|This is Period 4 See description of periods for full details.
649689|NCT01128270|E3|Reported Event|Chloral Hydrate +DCA (Therapeutic Dose)|This is Period 3. See description of periods for full details.
649690|NCT01128270|E2|Reported Event|Chloral Hydrate (Environmental)|This is Period 2. See description of periods for full details.
649691|NCT01128270|E1|Reported Event|1A: Chloral Hydrate+DCA (Environmental)|This is Period 1. See description of periods for full details.
649692|NCT01128296|B1|Baseline|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
649693|NCT01128296|P6|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
649694|NCT01128296|P5|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
649695|NCT01128296|P4|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
649696|NCT01128296|P3|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
649697|NCT01128296|P2|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
649698|NCT01128296|P1|Participant Flow|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
649699|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
649700|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
649701|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
649702|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
649703|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
649704|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
649705|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
649706|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
649776|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
649707|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)|Participants with pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (1200 mg/day) taken for 31 consecutive days until the day of surgery.
649708|NCT01128296|O6|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
649709|NCT01128296|O5|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
649710|NCT01128296|O4|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
649711|NCT01128296|O3|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
649712|NCT01128296|O2|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
649713|NCT01128296|O1|Outcome|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
649736|NCT01128400|P1|Participant Flow|rs1761667- AA Genotype|subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level and has a minor allele frequency of 38-48%.
649714|NCT01128296|E1|Reported Event|Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)|Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
649715|NCT01128361|B3|Baseline|Total|Total of all reporting groups
649716|NCT01128361|B2|Baseline|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
649717|NCT01128361|B1|Baseline|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
649718|NCT01128361|P2|Participant Flow|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
649719|NCT01128361|P1|Participant Flow|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
649720|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
649777|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
649778|NCT01128543|E1|Reported Event|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
649721|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
649722|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
649737|NCT01128400|O3|Outcome|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
649738|NCT01128400|O2|Outcome|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
649739|NCT01128400|O1|Outcome|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
649740|NCT01128400|O3|Outcome|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
661081|NCT01150981|O2|Outcome|Placebo|One capsule daily for 6 weeks.
649723|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
649724|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
649725|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
649726|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
649727|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
649728|NCT01128361|E2|Reported Event|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
649758|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
650212|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and crosslinked polyethylene liner.
649729|NCT01128361|E1|Reported Event|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
649730|NCT01128400|B4|Baseline|Total|Total of all reporting groups
649731|NCT01128400|B3|Baseline|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
649732|NCT01128400|B2|Baseline|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
649733|NCT01128400|B1|Baseline|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
649734|NCT01128400|P3|Participant Flow|rs1761667-AG Genotype|Heterozygous of CD36 gene rs1761667-A genotype.
649742|NCT01128400|O1|Outcome|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
649743|NCT01128400|E3|Reported Event|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
649744|NCT01128400|E2|Reported Event|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
649745|NCT01128400|E1|Reported Event|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
649746|NCT01128413|B3|Baseline|Total|Total of all reporting groups
649747|NCT01128413|B2|Baseline|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
649748|NCT01128413|B1|Baseline|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
649749|NCT01128413|P2|Participant Flow|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
649750|NCT01128413|P1|Participant Flow|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
649751|NCT01128413|O2|Outcome|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
649752|NCT01128413|O1|Outcome|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
649753|NCT01128413|E2|Reported Event|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
649754|NCT01128413|E1|Reported Event|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
649755|NCT01128426|B1|Baseline|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
649756|NCT01128426|P1|Participant Flow|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
649757|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
650213|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
649759|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
649760|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
649761|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
649762|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
649763|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
663960|NCT01160822|B8|Baseline|Total|Total of all reporting groups
649764|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
649765|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
649766|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
649767|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
649768|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
649769|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
649770|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
649771|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
649772|NCT01128426|E1|Reported Event|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
649773|NCT01128543|B1|Baseline|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
649774|NCT01128543|P1|Participant Flow|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
649775|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
650082|NCT01129102|E1|Reported Event|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg
NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
649779|NCT01128569|B1|Baseline|Placebo, FF 100 µg OD, FF/VI 100/25 µg OD in 1 of 6 Sequences|All participants received one of the following three treatments in one of three treatment periods once daily (OD) in the evening from the Dry Powder Inhaler (DPI) for 28 days: Placebo, Fluticasone Furoate (FF) 100 microgram (µg) dry inhalation powder, and FF/Vilanterol (FF/VI) 100/25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FF 100 µg, FF/VI 100/25 µg; (2) Placebo, FF/VI 100/25 µg, FF 100 µg; (3) FF 100 µg, FF/VI 100/25 µg, Placebo; (4) FF 100 µg, Placebo, FF/VI 100/25 µg; (5) FF/VI 100/25 µg, Placebo, FF 100 µg; (6) FF/VI 100/25 µg, FF 100 µg, Placebo. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
649780|NCT01128569|P6|Participant Flow|Sequence 6: FF/VI 100/25 µg, FF 100 µg, Placebo|Participants received FF/VI 100/25 µg, FF 100 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
649781|NCT01128569|P5|Participant Flow|Sequence 5: FF/VI 100/25 µg, Placebo, FF 100 µg|Participants received FF/VI 100/25 µg, placebo, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
649782|NCT01128569|P4|Participant Flow|Sequence 4: FF 100 µg, Placebo, FF/VI 100/25 µg|Participants received FF 100 µg, placebo, and FF/VI 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
649783|NCT01128569|P3|Participant Flow|Sequence 3: FF 100 µg, FF/VI 100/25 µg, Placebo|Participants received FF 100 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
650094|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
649784|NCT01128569|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg, FF 100 µg|Participants received placebo, FF/VI 100/25 µg, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
649785|NCT01128569|P1|Participant Flow|Sequence 1: Placebo, FF 100 µg, FF/VI 100/25 µg|Participants received placebo, Fluticasone Furoate (FF) 100 micrograms (µg), and FF/Vilanterol (VI) 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
649786|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
649787|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
649788|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
649789|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
649790|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
649791|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
649792|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
649793|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
649794|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
649795|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
649796|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
649797|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
649798|NCT01128569|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
650083|NCT01129115|B5|Baseline|Total|Total of all reporting groups
650421|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
649799|NCT01128569|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
649800|NCT01128569|E1|Reported Event|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
649801|NCT01128595|B1|Baseline|Placebo, FF/VI 100/25 µg OD, FF 100 µg OD, VI 25 µg|All participants received one of the following four treatments in one of four treatment periods once daily (OD) from the Dry Powder Inhaler (DPI) for 21 days: Placebo; Fluticasone Furoate /Vilanterol (FF/VI) 100/25 microgram (µg) dry inhalation powder; Fluticasone Furoate (FF) 100 µg dry inhalation powder; and Vilanterol (VI) 25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the four following sequences: (1) VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg; (2) FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg; (3) Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg; (4) FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo. The four treatment periods were separated by a washout period of 21 to 35 days.
649802|NCT01128595|P4|Participant Flow|Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo|Participants received FF 100 µg, VI 25 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
649803|NCT01128595|P3|Participant Flow|Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg|Participants received placebo, FF/VI 100/25 µg, VI 25 µg, and FF 100 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
649972|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
664082|NCT01160848|O3|Outcome|Area Cleaned With Ethyl Alcohol Solution|
649804|NCT01128595|P2|Participant Flow|Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg|Participants received FF/VI 100/25 µg, FF 100 µg, placebo, and VI 25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
649805|NCT01128595|P1|Participant Flow|Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg|Participants received Vilanterol (VI) 25 micrograms (µg), placebo, fluticasone furoate (FF) 100 µg, and FF/VI 100/25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
649806|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649807|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649808|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649809|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649810|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649811|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649812|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649813|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649814|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649815|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649816|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649817|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649818|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649819|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649820|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649821|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649822|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649823|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649824|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649825|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649826|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649827|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649828|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649829|NCT01128595|O1|Outcome|Placebo|
649830|NCT01128595|E4|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649831|NCT01128595|E3|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649832|NCT01128595|E2|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649833|NCT01128595|E1|Reported Event|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
649834|NCT01128738|B3|Baseline|Total|Total of all reporting groups
649973|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
649835|NCT01128738|B2|Baseline|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649836|NCT01128738|B1|Baseline|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649837|NCT01128738|P2|Participant Flow|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649838|NCT01128738|P1|Participant Flow|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649839|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649840|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649841|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649842|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649961|NCT01128829|P2|Participant Flow|"Sucralose Then Water"|"First intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose10 min before drinking a 75 g glucose load.
Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load."
649843|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649844|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649845|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649974|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
650122|NCT01129115|E2|Reported Event|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
649846|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649847|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649848|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649849|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649850|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649851|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649852|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649853|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649854|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649855|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649856|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
650084|NCT01129115|B4|Baseline|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
649857|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649858|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649859|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649860|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649861|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649862|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649863|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649864|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649865|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649866|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649867|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649868|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649869|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649962|NCT01128829|P1|Participant Flow|"Water Then Sucralose"|"First intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load.
Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose 10 min before drinking a 75 g glucose load."
650085|NCT01129115|B3|Baseline|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
649870|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649871|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649872|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649873|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649874|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649875|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649876|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649877|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649878|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649879|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649880|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649881|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649882|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649883|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
650209|NCT01121146|P2|Participant Flow|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
649884|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649885|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649886|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649887|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649888|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649889|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649890|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649891|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649892|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649893|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649894|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649895|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649896|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649963|NCT01128829|O1|Outcome|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
650086|NCT01129115|B2|Baseline|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
649897|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649898|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649899|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649900|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649901|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649902|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649903|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649904|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649905|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649906|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649907|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
649908|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649909|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649964|NCT01128829|E1|Reported Event|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
649965|NCT01128894|B3|Baseline|Total|Total of all reporting groups
649910|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649911|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
650460|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
649912|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649913|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649914|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649915|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649916|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649917|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649918|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649919|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
650068|NCT01129011|E1|Reported Event|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650069|NCT01129102|B4|Baseline|Total|Total of all reporting groups
649920|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649921|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649922|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649923|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649924|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649925|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649926|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649927|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649928|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649929|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
650070|NCT01129102|B3|Baseline|Placebo|Placebo for NPC-01
650071|NCT01129102|B2|Baseline|IKH-01|Norethisterone 1mg, Ethinyl estradiol 0.035mg
649930|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649931|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649932|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649933|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649934|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649935|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649936|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649937|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649938|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649939|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
650072|NCT01129102|B1|Baseline|NPC-01|Norethisterone 1mg, Ethinyl estradiol 0.02mg
650073|NCT01129102|P3|Participant Flow|Placebo|"Placebo for NPC-01
Placebo: Placebo for NPC-01"
649940|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649941|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649942|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649943|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649944|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649945|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649946|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649947|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649948|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649949|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
650074|NCT01129102|P2|Participant Flow|IKH-01|"Norethisterone 1mg, Ethinyl estradiol 0.035mg
IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg"
649950|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649951|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
664083|NCT01160848|O2|Outcome|Area Cleaned With Saline|
649952|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649953|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649954|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649955|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649956|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649957|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649958|NCT01128738|E2|Reported Event|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649959|NCT01128738|E1|Reported Event|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
649960|NCT01128829|B1|Baseline|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
649966|NCT01128894|B2|Baseline|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
649967|NCT01128894|B1|Baseline|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
649968|NCT01128894|P2|Participant Flow|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
649969|NCT01128894|P1|Participant Flow|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
649970|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
649971|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
649975|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
649976|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
649977|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
649978|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
649979|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
649980|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
649981|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
649982|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
649983|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
649984|NCT01128894|E2|Reported Event|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
649985|NCT01128894|E1|Reported Event|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
649986|NCT01128946|B1|Baseline|Overall|All randomized participants
649987|NCT01128946|P4|Participant Flow|NaF Toothpaste (675ppmF|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
649988|NCT01128946|P3|Participant Flow|Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
649989|NCT01128946|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures
649990|NCT01128946|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 gram (g) NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
649991|NCT01128946|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
650075|NCT01129102|P1|Participant Flow|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg
NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
650076|NCT01129102|O2|Outcome|Placebo|"Placebo for NPC-01
Placebo: Placebo for NPC-01"
649992|NCT01128946|O3|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
649993|NCT01128946|O2|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
649994|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
649995|NCT01128946|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
650092|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
664085|NCT01160848|E2|Reported Event|3 Areas Per Patient, 24 Hours|
649996|NCT01128946|O3|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
649997|NCT01128946|O2|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
649998|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
649999|NCT01128946|O2|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
650000|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
650001|NCT01128946|E4|Reported Event|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
650002|NCT01128946|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
650003|NCT01128946|E2|Reported Event|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
650004|NCT01128946|E1|Reported Event|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
650005|NCT01128959|B1|Baseline|Intravenous Carbamazepine (IV CBZ)|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
650006|NCT01128959|P1|Participant Flow|Intravenous Carbamazepine (IV CBZ)|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
650007|NCT01128959|O2|Outcome|Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
650077|NCT01129102|O1|Outcome|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg
NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
650078|NCT01129102|O2|Outcome|Placebo|"Placebo for NPC-01
Placebo: Placebo for NPC-01"
650008|NCT01128959|O1|Outcome|Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
650009|NCT01128959|E2|Reported Event|Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion|
650010|NCT01128959|E1|Reported Event|Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion|
650011|NCT01128972|B1|Baseline|All Study Participants|All randomized participants were included for baseline evaluation.
650012|NCT01128972|P5|Participant Flow|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
650013|NCT01128972|P4|Participant Flow|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650014|NCT01128972|P3|Participant Flow|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference sodium monofluorophosphate (NaMFP)/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650015|NCT01128972|P2|Participant Flow|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650016|NCT01128972|P1|Participant Flow|Test Dentifrice + Test Mouth Rinse (MR)|Participants were administered with treatment regimen comprising of test sodium fluoride (NaF) dentifrice [containing 1450 parts per million (ppm) fluoride (F) as NaF and potassium nitrate (KNO3)] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5 gram (g) test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
650017|NCT01128972|O2|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650018|NCT01128972|O1|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650019|NCT01128972|O2|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650020|NCT01128972|O1|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650021|NCT01128972|O5|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650022|NCT01128972|O4|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650079|NCT01129102|O1|Outcome|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg
NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
650023|NCT01128972|O3|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650024|NCT01128972|O2|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
650025|NCT01128972|O1|Outcome|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
650093|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
664086|NCT01160848|E1|Reported Event|3 Areas Per Patient, 3 Hours|
650026|NCT01128972|O5|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650027|NCT01128972|O4|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650028|NCT01128972|O3|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650029|NCT01128972|O2|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
650030|NCT01128972|O1|Outcome|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
650031|NCT01128972|O4|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650032|NCT01128972|O3|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650033|NCT01128972|O2|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650034|NCT01128972|O1|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
650035|NCT01128972|O4|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650036|NCT01128972|O3|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650037|NCT01128972|O2|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650038|NCT01128972|O1|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
650039|NCT01128972|E5|Reported Event|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650040|NCT01128972|E4|Reported Event|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
650041|NCT01128972|E3|Reported Event|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650042|NCT01128972|E2|Reported Event|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
650043|NCT01128972|E1|Reported Event|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
650044|NCT01129011|B3|Baseline|Total|Total of all reporting groups
650045|NCT01129011|B2|Baseline|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650046|NCT01129011|B1|Baseline|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650047|NCT01129011|P2|Participant Flow|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650048|NCT01129011|P1|Participant Flow|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650049|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650050|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650051|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650052|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650053|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650054|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650055|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650056|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650057|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650058|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650059|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650060|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650061|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650062|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650063|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650064|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650065|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650066|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
650067|NCT01129011|E2|Reported Event|Naproxen|Naproxen 500 mg dosed twice daily (bid)
650087|NCT01129115|B1|Baseline|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
650088|NCT01129115|P4|Participant Flow|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
650089|NCT01129115|P3|Participant Flow|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
650090|NCT01129115|P2|Participant Flow|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
650091|NCT01129115|P1|Participant Flow|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
650461|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
650095|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
650096|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
650097|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
650098|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
650099|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
650100|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
650101|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
650102|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
650103|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
650104|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
650105|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
650106|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
650107|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
650108|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
650109|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
650110|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
650111|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
650112|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
650113|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
650114|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
650115|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
650116|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
650117|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
650118|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
650119|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
650120|NCT01129115|E4|Reported Event|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
650121|NCT01129115|E3|Reported Event|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
650123|NCT01129115|E1|Reported Event|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
650124|NCT01129128|B4|Baseline|Total|Total of all reporting groups
650125|NCT01129128|B3|Baseline|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
650126|NCT01129128|B2|Baseline|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
650127|NCT01129128|B1|Baseline|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
650128|NCT01129128|P3|Participant Flow|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
650129|NCT01129128|P2|Participant Flow|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
650130|NCT01129128|P1|Participant Flow|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
650131|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
650132|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
650133|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
650134|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
650135|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
650136|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
650137|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
650138|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
650139|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
650140|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
650141|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
650142|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
650143|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
650144|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
650145|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
650146|NCT01129128|E3|Reported Event|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
650147|NCT01129128|E2|Reported Event|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
650148|NCT01129128|E1|Reported Event|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
650149|NCT01129141|B3|Baseline|Total|Total of all reporting groups
650171|NCT01129245|O2|Outcome|Placebo|received placebo during menstrual cycle
650210|NCT01121146|P1|Participant Flow|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
650150|NCT01129141|B2|Baseline|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
650151|NCT01129141|B1|Baseline|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
650152|NCT01129141|P2|Participant Flow|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
650153|NCT01129141|P1|Participant Flow|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
650154|NCT01129141|O2|Outcome|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
650155|NCT01129141|O1|Outcome|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
650156|NCT01129141|E2|Reported Event|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
650157|NCT01129141|E1|Reported Event|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
650158|NCT01129206|B1|Baseline|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies"
650159|NCT01129206|P1|Participant Flow|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies"
650160|NCT01129206|O2|Outcome|RECIST Criteria Per CT|
650161|NCT01129206|O1|Outcome|PERCIST Criteria Per PET|
650162|NCT01129206|O1|Outcome|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies"
650163|NCT01129206|O1|Outcome|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies"
650164|NCT01129206|O1|Outcome|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies"
650165|NCT01129206|E1|Reported Event|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies"
650166|NCT01129245|B3|Baseline|Total|Total of all reporting groups
650167|NCT01129245|B2|Baseline|Celecoxib First, Then Placebo|control menstrual cycle, celecoxib menstrual cycle, placebo menstrual cycle
650168|NCT01129245|B1|Baseline|Placebo First, Then Celecoxib|control menstrual cycle, placebo menstrual cycle, and then celecoxib menstrual cycle
650169|NCT01129245|P2|Participant Flow|Celecoxib First, Then Placebo|"receive celebrex based on hormone and ultrasound findings and timing of menstrual cycle
celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings
Placebo"
650170|NCT01129245|P1|Participant Flow|Placebo First, Then Celecoxib|"receive celebrex based on hormone and ultrasound findings and timing of menstrual cycle
celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings
Placebo"
650172|NCT01129245|O1|Outcome|Celebrex|"receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results
celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings"
650173|NCT01129245|E2|Reported Event|Placebo|received placebo drug
650174|NCT01129245|E1|Reported Event|Celebrex|"receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results
celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings"
650175|NCT01129284|B4|Baseline|Total|Total of all reporting groups
650176|NCT01129284|B3|Baseline|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease)
650177|NCT01129284|B2|Baseline|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD)
650178|NCT01129284|B1|Baseline|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy
650179|NCT01129284|P3|Participant Flow|Immunoglobulin A (IgA) Nephropathy|Subjects diagnosed with Immunoglobulin A (IgA) nephropathy (Berger's disease) were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
650180|NCT01129284|P2|Participant Flow|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD) were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
650181|NCT01129284|P1|Participant Flow|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
650182|NCT01129284|O3|Outcome|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
650183|NCT01129284|O2|Outcome|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
650184|NCT01129284|O1|Outcome|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
650231|NCT01121172|E2|Reported Event|Lean|lean children and adolescents matched for age and gender to the obese group
650185|NCT01129284|O3|Outcome|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
650186|NCT01129284|O2|Outcome|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
650187|NCT01129284|O1|Outcome|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
650188|NCT01129284|E3|Reported Event|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
650189|NCT01129284|E2|Reported Event|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
650190|NCT01129284|E1|Reported Event|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
650191|NCT01129336|B3|Baseline|Total|Total of all reporting groups
650192|NCT01129336|B2|Baseline|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
650193|NCT01129336|B1|Baseline|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
650194|NCT01129336|P2|Participant Flow|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
650195|NCT01129336|P1|Participant Flow|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
650196|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
650197|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
650198|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
650199|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
650200|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
650201|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
650202|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
650203|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
650204|NCT01129336|E2|Reported Event|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
650205|NCT01129336|E1|Reported Event|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
650206|NCT01121146|B3|Baseline|Total|Total of all reporting groups
650207|NCT01121146|B2|Baseline|Standard Enduron Polyethylene|Total Hip Replacement : Comparison of Marathon and Enduron polyethylene
650208|NCT01121146|B1|Baseline|Crosslinked Marathon Polyethylene|Total Hip Replacement : Comparison of Marathon and Enduron polyethylene
650422|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
650214|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
650215|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
650216|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
650217|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
650218|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
650219|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
650220|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
650221|NCT01121146|E2|Reported Event|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
650222|NCT01121146|E1|Reported Event|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
650223|NCT01121172|B3|Baseline|Total|Total of all reporting groups
650224|NCT01121172|B2|Baseline|Lean|lean children and adolescents matched for age and gender to the obese group
650225|NCT01121172|B1|Baseline|Obese|obese children and adolescents according to International Obesity Task Force criteria
650226|NCT01121172|P2|Participant Flow|Lean|lean children and adolescents matched for age and gender to the obese group
650227|NCT01121172|P1|Participant Flow|Obese|obese children and adolescents according to International Obesity Task Force criteria
650228|NCT01121172|O1|Outcome|Obese Group|Obese children and adolescents according to IOTF criteria
650229|NCT01121172|O2|Outcome|Lean|lean children and adolescents matched for age and gender to the obese group
650230|NCT01121172|O1|Outcome|Obese|obese children and adolescents according to International Obesity Task Force criteria
650232|NCT01121172|E1|Reported Event|Obese|obese children and adolescents according to International Obesity Task Force criteria
650233|NCT01121185|B3|Baseline|Total|Total of all reporting groups
650234|NCT01121185|B2|Baseline|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650235|NCT01121185|B1|Baseline|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650236|NCT01121185|P2|Participant Flow|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650237|NCT01121185|P1|Participant Flow|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650238|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650239|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650240|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650241|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650242|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650243|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650265|NCT01121211|O2|Outcome|Placebo|"Placebo x 24 weeks
Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.
Placebo: Placebo transdermal patch x 24 weeks"
650244|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650245|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650246|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650247|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650248|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650280|NCT01121393|B3|Baseline|Total|Total of all reporting groups
650281|NCT01121393|B2|Baseline|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650249|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650250|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650251|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650252|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650253|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650254|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650255|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650256|NCT01121185|E2|Reported Event|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650257|NCT01121185|E1|Reported Event|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
650258|NCT01121211|B3|Baseline|Total|Total of all reporting groups
650259|NCT01121211|B2|Baseline|Placebo|"Placebo x 24 weeks
Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.
Placebo: Placebo transdermal patch x 24 weeks"
650260|NCT01121211|B1|Baseline|Testosterone|"Testosterone x 24 weeks
Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.
Placebo: Placebo transdermal patch x 24 weeks"
650261|NCT01121211|P2|Participant Flow|Placebo|"Placebo x 24 weeks
Placebo: Placebo transdermal patch x 24 weeks"
650262|NCT01121211|P1|Participant Flow|Testosterone|"Testosterone x 24 weeks
Testosterone: Testosterone 300mcg transdermal patch x 24 weeks."
650263|NCT01121211|O2|Outcome|Placebo|"Placebo x 24 weeks
Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.
Placebo: Placebo transdermal patch x 24 weeks"
650264|NCT01121211|O1|Outcome|Testosterone|"Testosterone x 24 weeks
Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.
Placebo: Placebo transdermal patch x 24 weeks"
650266|NCT01121211|O1|Outcome|Testosterone|"Testosterone x 24 weeks
Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.
Placebo: Placebo transdermal patch x 24 weeks"
650267|NCT01121211|E2|Reported Event|Placebo|"Placebo x 24 weeks
Placebo: Placebo transdermal patch x 24 weeks"
650268|NCT01121211|E1|Reported Event|Testosterone|"Testosterone x 24 weeks
Testosterone: Testosterone 300mcg transdermal patch x 24 weeks."
650269|NCT01121263|B3|Baseline|Total|Total of all reporting groups
650270|NCT01121263|B2|Baseline|Cohort 2: Intervention Cohort - PCI Group (N=98)|Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
650271|NCT01121263|B1|Baseline|Cohort 2: Intervention Cohort - HCR Group (N=200)|Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
650272|NCT01121263|P2|Participant Flow|Cohort 2: Intervention Cohort - PCI Group (N=98)|Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
650273|NCT01121263|P1|Participant Flow|Cohort 2: Intervention Cohort - HCR Group (N=200)|Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
650274|NCT01121263|O2|Outcome|PCI Group (N=98)|Occurrence of MACCE through the end of study in Cohort 2: Intervention Cohort - PCI Group
650275|NCT01121263|O1|Outcome|HCR Group (N=200)|Occurrence of MACCE through the end of study in Cohort 2: Intervention Cohort - HCR Group
650276|NCT01121263|O2|Outcome|PCI Group (N=98)|Primary Outcome in Cohort 2: Intervention Cohort - PCI Group
650277|NCT01121263|O1|Outcome|HCR Group (N=200)|Primary Outcome in Cohort 2: Intervention Cohort - HCR Group
650278|NCT01121263|E2|Reported Event|PCI Group (N=98)|Serious Adverse Events in Cohort 2: Intervention Cohort - PCI Group
650279|NCT01121263|E1|Reported Event|HCR Group (N=200)|Serious Adverse Events in Cohort 2: Intervention Cohort - HCR Group
650282|NCT01121393|B1|Baseline|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650283|NCT01121393|P2|Participant Flow|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics.
650284|NCT01121393|P1|Participant Flow|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 milligram (mg) once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction.
650285|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650286|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650287|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650288|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650289|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.
650290|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.)
650291|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.
650292|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.
650293|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.)
650294|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.
650295|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) orally after a dose escalation.
650296|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.) orally
650297|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) orally after a dose reduction.
650298|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650299|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650300|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650301|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650302|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650303|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650304|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650305|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650423|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
650306|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650307|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650308|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650309|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650310|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650311|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650312|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650313|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650314|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650315|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650316|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650317|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650318|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
667018|NCT01175005|E1|Reported Event|Fever and a Central Venous Catheter|
650319|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650320|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650321|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650322|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650323|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650324|NCT01121393|E2|Reported Event|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
650325|NCT01121393|E1|Reported Event|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
650326|NCT01121406|B3|Baseline|Total|Total of all reporting groups
650327|NCT01121406|B2|Baseline|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650328|NCT01121406|B1|Baseline|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650329|NCT01121406|P2|Participant Flow|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650330|NCT01121406|P1|Participant Flow|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650331|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650332|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650333|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650334|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650335|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650336|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650337|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650338|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650339|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650340|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650341|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650342|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650343|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650344|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650345|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650346|NCT01121406|O3|Outcome|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
650347|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650406|NCT01129557|P3|Participant Flow|Tekturna + Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
650348|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650349|NCT01121406|O3|Outcome|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
650350|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650351|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650352|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650353|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650354|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650355|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650356|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650357|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650358|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650359|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650407|NCT01129557|P2|Participant Flow|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
650408|NCT01129557|P1|Participant Flow|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
650409|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
650410|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
650411|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
650360|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650361|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650362|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650363|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650446|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
650364|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650365|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650366|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650367|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650368|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650369|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650370|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650371|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650372|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650373|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650374|NCT01121406|E3|Reported Event|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
650375|NCT01121406|E2|Reported Event|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:
Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
650447|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
650448|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
650376|NCT01121406|E1|Reported Event|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.
Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
650377|NCT01129531|B4|Baseline|Total|Total of all reporting groups
650378|NCT01129531|B3|Baseline|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
650379|NCT01129531|B2|Baseline|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
650380|NCT01129531|B1|Baseline|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
650381|NCT01129531|P3|Participant Flow|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
650382|NCT01129531|P2|Participant Flow|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
650383|NCT01129531|P1|Participant Flow|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
650384|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
650385|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
650386|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
650387|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. Participants received two treatments 12 weeks apart.
650388|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
650389|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
650390|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
650391|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
650392|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
650393|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
650394|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
650395|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
650396|NCT01129531|E6|Reported Event|Placebo_Cycle 2|One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
650397|NCT01129531|E5|Reported Event|AGN-214868 16.25 μg_ Cycle 2|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
650398|NCT01129531|E4|Reported Event|AGN-214868 3.25 μg_ Cycle 2|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
650399|NCT01129531|E3|Reported Event|Placebo_Cycle 1|One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
650400|NCT01129531|E2|Reported Event|AGN-214868 16.25 μg_Cycle 1|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
650401|NCT01129531|E1|Reported Event|AGN-214868 3.25 μg_Cycle 1|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
650402|NCT01129557|B4|Baseline|Total|Total of all reporting groups
650403|NCT01129557|B3|Baseline|Tekturna+Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
650404|NCT01129557|B2|Baseline|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
650405|NCT01129557|B1|Baseline|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
650424|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
650425|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
650426|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
650427|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
650428|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
650429|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
650430|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
650431|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
650432|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
650433|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
650434|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
650435|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
650436|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
650437|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
650438|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
650439|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
650440|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
650441|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
650442|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
650443|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
650444|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
650445|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
650462|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
650463|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
650464|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
650465|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
650466|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
650467|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
650468|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
650469|NCT01129557|O3|Outcome|Tekturna + Diovan|aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
650470|NCT01129557|O2|Outcome|Tekturna|aliskiren [direct renin inhibitor (DRI)] : Tekturna 300 mg PO once daily for 9 months
650471|NCT01129557|O1|Outcome|Diovan|valsartan [angiotensin receptor blocker (ARB)] : Diovan 320 mg PO once daily for 9 months
650472|NCT01129557|E3|Reported Event|Tekturna + Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
650473|NCT01129557|E2|Reported Event|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
650474|NCT01129557|E1|Reported Event|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
650475|NCT01129583|B3|Baseline|Total|Total of all reporting groups
650476|NCT01129583|B2|Baseline|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650477|NCT01129583|B1|Baseline|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650478|NCT01129583|P2|Participant Flow|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650479|NCT01129583|P1|Participant Flow|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650480|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650481|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650482|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650483|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650484|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650485|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650486|NCT01129583|E2|Reported Event|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650487|NCT01129583|E1|Reported Event|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
650488|NCT01129622|B1|Baseline|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
650489|NCT01129622|P1|Participant Flow|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
650490|NCT01129622|O1|Outcome|Adverse Events|Hypo-estrogenic side effects
650491|NCT01129622|O1|Outcome|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
650492|NCT01129622|E1|Reported Event|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
650493|NCT01129765|B1|Baseline|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
650494|NCT01129765|P1|Participant Flow|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
650495|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
650496|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
650497|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
650498|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
650499|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
650500|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
650501|NCT01129765|E1|Reported Event|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
650502|NCT01129778|B1|Baseline|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
650503|NCT01129778|P1|Participant Flow|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
650504|NCT01129778|O1|Outcome|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
650505|NCT01129778|O1|Outcome|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
650506|NCT01129778|E1|Reported Event|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
650507|NCT01130740|B3|Baseline|Total|Total of all reporting groups
650508|NCT01130740|B2|Baseline|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
650509|NCT01130740|B1|Baseline|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
650510|NCT01130740|P2|Participant Flow|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
650511|NCT01130740|P1|Participant Flow|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
650512|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
650513|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
650514|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
650515|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
650516|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
650517|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
650518|NCT01130740|E2|Reported Event|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
650519|NCT01130740|E1|Reported Event|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
650520|NCT01130831|B1|Baseline|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650521|NCT01130831|P1|Participant Flow|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650522|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650523|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650524|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650525|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650526|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|Calcium-based phosphate binder therapy for >=3 months prior.
650527|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650528|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|Calcium-based phosphate binder therapy of >=3 months of treatment.
650529|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650530|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650531|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650532|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650533|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650534|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650535|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the iPTH KDOQI target on lanthanum carbonate.
650536|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum phosphate KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
650537|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum calcium-phosphorous product KDOQI target on lanthanum carbonate.
650538|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum calcium KDOQI target on lanthanum carbonate.
650539|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum phosphorous KDOQI target on lanthanum carbonate.
650540|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum calcium-phosphorous product levels KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
650541|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum calcium-phosphorous product KDOQI target on previous calcium-based phosphate binder therapy for >=3 months prior to receiving lanthanum carbonate treatment.
650542|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum calcium KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
650543|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum calcium KDOQI target on previous calcium-based phosphate binder therapy for >=3 months prior to receiving lanthanum carbonate treatment.
650544|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of >=3 months of treatment prior to receiving lanthanum carbonate treatment.
650545|NCT01130831|E1|Reported Event|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
650546|NCT01130844|B4|Baseline|Total|Total of all reporting groups
650547|NCT01130844|B3|Baseline|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650548|NCT01130844|B2|Baseline|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650549|NCT01130844|B1|Baseline|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650550|NCT01130844|P3|Participant Flow|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650551|NCT01130844|P2|Participant Flow|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650552|NCT01130844|P1|Participant Flow|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650553|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650554|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650555|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650556|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650557|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650558|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650559|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650560|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650561|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650562|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650563|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650564|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650565|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650566|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650567|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650568|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650569|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650570|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650571|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650572|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650573|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650574|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650575|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650576|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650577|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650578|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650579|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650580|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650581|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650582|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650583|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650584|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650585|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650586|NCT01130844|E3|Reported Event|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650587|NCT01130844|E2|Reported Event|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650588|NCT01130844|E1|Reported Event|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
650589|NCT01130883|B1|Baseline|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650590|NCT01130883|P1|Participant Flow|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650591|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650592|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650593|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650594|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650595|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650596|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650597|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650598|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650599|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650600|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650601|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650602|NCT01130883|E1|Reported Event|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
650603|NCT01130974|B3|Baseline|Total|Total of all reporting groups
650604|NCT01130974|B2|Baseline|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
650605|NCT01130974|B1|Baseline|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
650606|NCT01130974|P2|Participant Flow|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
650607|NCT01130974|P1|Participant Flow|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
650608|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
650609|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
650610|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
650611|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
650612|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
650613|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
650614|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
650615|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
650616|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
650617|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
650618|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
650619|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
650620|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
650621|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
650622|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
650623|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
650624|NCT01130974|E2|Reported Event|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
650625|NCT01130974|E1|Reported Event|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
650626|NCT01131052|B3|Baseline|Total|Total of all reporting groups
650627|NCT01131052|B2|Baseline|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
650628|NCT01131052|B1|Baseline|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
650629|NCT01131052|P2|Participant Flow|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
650630|NCT01131052|P1|Participant Flow|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
650631|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
650632|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
650633|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
650634|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
650635|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
650636|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
650637|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
650638|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
650639|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
650640|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
650641|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
650642|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
650643|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
650644|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
651979|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
650645|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
650646|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
650647|NCT01131052|E2|Reported Event|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
650648|NCT01131052|E1|Reported Event|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
650649|NCT01131065|B1|Baseline|Hepatitis B Immune Globulin|"Treatment group
Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
650650|NCT01131065|P1|Participant Flow|Hepatitis B Immune Globulin|"Treatment group
Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
650651|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group
Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
650652|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group
Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
650653|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group
Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
650654|NCT01131065|E1|Reported Event|Hepatitis B Immune Globulin|"Treatment group
Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
650655|NCT01131078|B4|Baseline|Total|Total of all reporting groups
650656|NCT01131078|B3|Baseline|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650727|NCT01131130|E2|Reported Event|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens
Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
650657|NCT01131078|B2|Baseline|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650658|NCT01131078|B1|Baseline|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650659|NCT01131078|P3|Participant Flow|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650660|NCT01131078|P2|Participant Flow|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650661|NCT01131078|P1|Participant Flow|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 milligrams per kilogram (mg/kg) intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 milligrams per meter squared (mg/m^2) intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or stable disease (SD) were treated with bevacizumab alone until unacceptable toxicity, progressive disease (PD), or participant withdrawal.
650662|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650750|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
651091|NCT01132664|P4|Participant Flow|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
650663|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650664|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650665|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650666|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650667|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650668|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650669|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650732|NCT01131182|P2|Participant Flow|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription
650670|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650671|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650672|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650673|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650674|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650675|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650840|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
650676|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650677|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650678|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650679|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650680|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650681|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650682|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650733|NCT01131182|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period
651628|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
650683|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650684|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650685|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650686|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650687|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650688|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650689|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650690|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal..
650691|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650692|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650693|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650694|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650695|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650728|NCT01131130|E1|Reported Event|Investigational Contact Lens|"Bausch & Lomb
Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
650729|NCT01131182|B3|Baseline|Total|Total of all reporting groups
652553|NCT01134276|O2|Outcome|ERBD|finial biliary drainage procedure: biliary drainage via ERBD or ENBD
650696|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650697|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650698|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650699|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650700|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650701|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650702|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650703|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650704|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650705|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650706|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650707|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650708|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650730|NCT01131182|B2|Baseline|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription. All participants as treated population, n=514.
650731|NCT01131182|B1|Baseline|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period. All participants as treated population, n=507.
650709|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650710|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650711|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650712|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650713|NCT01131078|E3|Reported Event|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
650751|NCT01131299|E1|Reported Event|Entire Study Population|"Randomized subjects receiving active comparator
Alpha cyclodextrin: 2g PO 3 times a day for 12-14 weeks
Randomized subjects receiving placebo comparator
Placebo: 2 tablets PO 3 times a day for 12-14 weeks"
650752|NCT01131455|B4|Baseline|Total|Total of all reporting groups
650841|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
650714|NCT01131078|E2|Reported Event|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650715|NCT01131078|E1|Reported Event|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
650716|NCT01131130|B1|Baseline|Over All Study|Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
650717|NCT01131130|P1|Participant Flow|Over All Study|Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
650718|NCT01131130|O2|Outcome|Air Optix Aqua|"Ciba Vision
Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
650719|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb
Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
650720|NCT01131130|O2|Outcome|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens
Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
650721|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb
Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
650722|NCT01131130|O2|Outcome|Air Optix Aqua|"Ciba Vision
Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
650723|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb
Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
650724|NCT01131130|O2|Outcome|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens
Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
650725|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb
Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
650726|NCT01131130|E3|Reported Event|Air Optix Aqua|"Ciba Vision
Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
652554|NCT01134276|O1|Outcome|PTBD|finial biliary drainage procedure: biliary drainage via PTBD
650734|NCT01131182|O2|Outcome|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
650735|NCT01131182|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
650736|NCT01131182|O2|Outcome|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
650737|NCT01131182|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
650738|NCT01131182|E2|Reported Event|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
650739|NCT01131182|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
650740|NCT01131299|B1|Baseline|Alpha Cyclodextrin & Placebo Participants|"Randomized subjects receiving alpha cyclodextrin
Alpha cyclodextrin: 2 g PO 3 times a day for 12- 14 weeks
Randomized subjects receiving placebo comparator
Placebo: 2 tablets PO 3 times a day for 12-14 weeks"
650741|NCT01131299|P2|Participant Flow|Alpha Cyclodextrin First, Then Placebo|"Subjects will receive alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks. After a one-week washout, the subjects will receive placebo.
Subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks"
650742|NCT01131299|P1|Participant Flow|Placebo First, Then Alpha Cyclodextrin|"Randomized subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks. After a one-week washout, the subjects will receive alpha cyclodextrin.
Alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks"
650743|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
650744|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
650745|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
650746|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
650747|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
650748|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
650749|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
650753|NCT01131455|B3|Baseline|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
650754|NCT01131455|B2|Baseline|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
650755|NCT01131455|B1|Baseline|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.
Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
650756|NCT01131455|P3|Participant Flow|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
650757|NCT01131455|P2|Participant Flow|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
650792|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650758|NCT01131455|P1|Participant Flow|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.
Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
650759|NCT01131455|O3|Outcome|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
650760|NCT01131455|O2|Outcome|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
650778|NCT01131520|B2|Baseline|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650779|NCT01131520|B1|Baseline|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650842|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
650761|NCT01131455|O1|Outcome|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.
Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
650762|NCT01131455|E3|Reported Event|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
650763|NCT01131455|E2|Reported Event|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
650764|NCT01131455|E1|Reported Event|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.
Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
650765|NCT01131494|B1|Baseline|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
650766|NCT01131494|P1|Participant Flow|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
650767|NCT01131494|O2|Outcome|Post-intervention Measure|Measurements of the group made after the intervention.
650768|NCT01131494|O1|Outcome|Pre-intervention Measure|Measurements of the group made before begin intervention.
650769|NCT01131494|O2|Outcome|Post-intervention Measure|Measurements of the group made after the intervention.
650770|NCT01131494|O1|Outcome|Pre-intervention Measure|Measurements of the group made before begin intervention.
650771|NCT01131494|E1|Reported Event|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
650772|NCT01131507|B1|Baseline|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
650773|NCT01131507|P1|Participant Flow|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
650774|NCT01131507|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
650775|NCT01131507|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
650776|NCT01131507|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
650777|NCT01131520|B3|Baseline|Total|Total of all reporting groups
650802|NCT01131585|B3|Baseline|Total|Total of all reporting groups
650780|NCT01131520|P2|Participant Flow|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650781|NCT01131520|P1|Participant Flow|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650782|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650783|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650784|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650785|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650786|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650787|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650788|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650789|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650790|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650791|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650819|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
650793|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650794|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650795|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650796|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650797|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650798|NCT01131520|O2|Outcome|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650799|NCT01131520|O1|Outcome|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650800|NCT01131520|E2|Reported Event|Counselor Delivered Brief Intervention|"This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing."
650801|NCT01131520|E1|Reported Event|Computerized Brief Intervention|"Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session."
650803|NCT01131585|B2|Baseline|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
650804|NCT01131585|B1|Baseline|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
650805|NCT01131585|P2|Participant Flow|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
650806|NCT01131585|P1|Participant Flow|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
650807|NCT01131585|O2|Outcome|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
650808|NCT01131585|O1|Outcome|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
650809|NCT01131585|E2|Reported Event|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
650810|NCT01131585|E1|Reported Event|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
650811|NCT01131676|B4|Baseline|Total|Total of all reporting groups
650812|NCT01131676|B3|Baseline|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
650813|NCT01131676|B2|Baseline|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
650814|NCT01131676|B1|Baseline|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
650815|NCT01131676|P3|Participant Flow|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
650816|NCT01131676|P2|Participant Flow|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
650817|NCT01131676|P1|Participant Flow|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
650818|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
652973|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
650820|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
650821|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
650822|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
650823|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
650824|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
650825|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
650826|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
650827|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
650828|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
650829|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
650830|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
650831|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
650832|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
650833|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
650834|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
650835|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
650836|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
650837|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
650838|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
650839|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
650843|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
650844|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
650845|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
650846|NCT01131676|E3|Reported Event|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
650847|NCT01131676|E2|Reported Event|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
650848|NCT01131676|E1|Reported Event|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
650849|NCT01131884|B3|Baseline|Total|Total of all reporting groups
650850|NCT01131884|B2|Baseline|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.
Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
650851|NCT01131884|B1|Baseline|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
650852|NCT01131884|P2|Participant Flow|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.
Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
650853|NCT01131884|P1|Participant Flow|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
650854|NCT01131884|O2|Outcome|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.
Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
650855|NCT01131884|O1|Outcome|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
650856|NCT01131884|E2|Reported Event|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.
Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
650857|NCT01131884|E1|Reported Event|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
650858|NCT01132118|B3|Baseline|Total|Total of all reporting groups
650859|NCT01132118|B2|Baseline|Placebo Then HCQ|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650903|NCT01132313|B12|Baseline|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
651003|NCT01132495|E1|Reported Event|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment
Stenting plus OMT: FFR guided PCI, plus OMT"
650860|NCT01132118|B1|Baseline|HCQ Then Placebo|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650861|NCT01132118|P2|Participant Flow|Placebo Then HCQ|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650862|NCT01132118|P1|Participant Flow|HCQ Then Placebo|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650863|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
650864|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650865|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
650866|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650867|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
650868|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650869|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
650870|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650871|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
650872|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650873|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
650874|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650875|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
650876|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650877|NCT01132118|E2|Reported Event|Placebo|Participants received Placebo tablets for 8 weeks.
650878|NCT01132118|E1|Reported Event|Hydroxychloroquine|"Participants received hydroxychloroquine (HCQ) for 8 weeks.
Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
650879|NCT01132144|B3|Baseline|Total|Total of all reporting groups
650880|NCT01132144|B2|Baseline|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
650881|NCT01132144|B1|Baseline|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
650882|NCT01132144|P2|Participant Flow|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds
650904|NCT01132313|B11|Baseline|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
650883|NCT01132144|P1|Participant Flow|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
650884|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
650885|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
650886|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
650887|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
650888|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
650889|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
650890|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
650913|NCT01132313|B2|Baseline|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
651142|NCT01132690|E2|Reported Event|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
650891|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
650892|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
650893|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
650894|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds
650895|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
650896|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
650897|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
650898|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
650899|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.
650900|NCT01132144|E2|Reported Event|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
650901|NCT01132144|E1|Reported Event|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
650902|NCT01132313|B13|Baseline|Total|Total of all reporting groups
651001|NCT01132495|E3|Reported Event|Cohort B - Follow-up|Observation with treatment based on physician preference
650905|NCT01132313|B10|Baseline|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650906|NCT01132313|B9|Baseline|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650907|NCT01132313|B8|Baseline|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650908|NCT01132313|B7|Baseline|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650909|NCT01132313|B6|Baseline|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650910|NCT01132313|B5|Baseline|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650911|NCT01132313|B4|Baseline|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650912|NCT01132313|B3|Baseline|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
651088|NCT01132664|B2|Baseline|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
651143|NCT01132690|E1|Reported Event|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
650914|NCT01132313|B1|Baseline|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
650915|NCT01132313|P12|Participant Flow|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
650916|NCT01132313|P11|Participant Flow|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
650917|NCT01132313|P10|Participant Flow|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650918|NCT01132313|P9|Participant Flow|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650919|NCT01132313|P8|Participant Flow|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650920|NCT01132313|P7|Participant Flow|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650921|NCT01132313|P6|Participant Flow|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650922|NCT01132313|P5|Participant Flow|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650923|NCT01132313|P4|Participant Flow|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650924|NCT01132313|P3|Participant Flow|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650925|NCT01132313|P2|Participant Flow|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
650926|NCT01132313|P1|Participant Flow|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
650927|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
650928|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
650929|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650930|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650931|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650932|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
650933|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
650934|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650935|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650936|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650937|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650938|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650939|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650940|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650941|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650942|NCT01132313|O7|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650943|NCT01132313|O6|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650944|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650945|NCT01132313|O4|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650946|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650947|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
651002|NCT01132495|E2|Reported Event|Cohort A - OMT Alone|"Optimal medical treatment alone
Standard of care: OMT alone"
650948|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
650949|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650950|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650951|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650952|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650953|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650954|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
650955|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
650956|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
650957|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
650958|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650959|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650960|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650961|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650962|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650963|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650964|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650965|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650966|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
650967|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
650968|NCT01132313|E12|Reported Event|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
650969|NCT01132313|E11|Reported Event|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
651117|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
650970|NCT01132313|E10|Reported Event|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650971|NCT01132313|E9|Reported Event|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650972|NCT01132313|E8|Reported Event|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650973|NCT01132313|E7|Reported Event|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650974|NCT01132313|E6|Reported Event|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650975|NCT01132313|E5|Reported Event|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650976|NCT01132313|E4|Reported Event|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
650977|NCT01132313|E3|Reported Event|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
651089|NCT01132664|B1|Baseline|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
651090|NCT01132664|P5|Participant Flow|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
650978|NCT01132313|E2|Reported Event|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
650979|NCT01132313|E1|Reported Event|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
650980|NCT01132326|B1|Baseline|Droxidopa|"Open-Label Droxidopa
Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
650981|NCT01132326|P1|Participant Flow|Droxidopa|"Open-Label Droxidopa
Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
650982|NCT01132326|O1|Outcome|Droxidopa|"Open-Label Droxidopa
Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
650983|NCT01132326|E1|Reported Event|Droxidopa|"Open-Label Droxidopa
Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
650984|NCT01132378|B1|Baseline|Median Parepatellar Approach or Minimidvastus Approach|Total knee arthroplasty : staged bilateral total knee arthroplasty
650985|NCT01132378|P1|Participant Flow|Mini-midvastus Incision|"Total knee arthroplasty : staged bilateral total knee arthroplasty
Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini-midvastus approach in one knee and mini-Medial Parapatellar Approachthe in another knee (left or right)within no more than 7 days."
650986|NCT01132378|O2|Outcome|Mini-midvastus Approach|Total knee arthroplasty : staged bilateral total knee arthroplasty
650987|NCT01132378|O1|Outcome|Medial Parapatellar Approach|Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
650988|NCT01132378|E1|Reported Event|Midvastus or Medial Parapatellar Approach|Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
650989|NCT01132495|B5|Baseline|Total|Total of all reporting groups
650990|NCT01132495|B4|Baseline|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
650991|NCT01132495|B3|Baseline|Cohort B - Follow-up|Observation with treatment based on physician preference
650992|NCT01132495|B2|Baseline|Cohort A - OMT Alone|"Optimal medical treatment alone
Standard of care: OMT alone"
650993|NCT01132495|B1|Baseline|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment
Stenting plus OMT: FFR guided PCI, plus OMT"
650994|NCT01132495|P4|Participant Flow|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
650995|NCT01132495|P3|Participant Flow|Cohort B - Follow-up|Observation with treatment based on physician preference
650996|NCT01132495|P2|Participant Flow|Cohort A - OMT Alone|"Optimal medical treatment alone
Standard of care: OMT alone"
650997|NCT01132495|P1|Participant Flow|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment
Stenting plus OMT: FFR guided PCI, plus OMT"
650998|NCT01132495|O2|Outcome|Cohort A - OMT Alone|Optimal medical treatment alone - Standard of care: OMT alone
650999|NCT01132495|O1|Outcome|Cohort A - PCI Plus OMT|PCI plus optimal medical treatment - Stenting plus OMT: FFR guided PCI, plus OMT
651000|NCT01132495|E4|Reported Event|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
651004|NCT01132508|B1|Baseline|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651005|NCT01132508|P1|Participant Flow|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651006|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651007|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651008|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651009|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651010|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651011|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651012|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651013|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651014|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651015|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651016|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651017|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651018|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651624|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration < 4 weeks
651019|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651020|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651021|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651022|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651023|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651024|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651025|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651026|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651027|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651028|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651029|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651030|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651031|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651032|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651033|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651625|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
651034|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651035|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651036|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651037|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651038|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651039|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651040|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651041|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651042|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651043|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651044|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651045|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651046|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651047|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651048|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651626|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
651049|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651050|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651051|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651052|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651053|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651054|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651055|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651056|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651057|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651058|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651059|NCT01132508|E1|Reported Event|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
651060|NCT01132547|B3|Baseline|Total|Total of all reporting groups
651061|NCT01132547|B2|Baseline|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally"
651062|NCT01132547|B1|Baseline|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally"
651063|NCT01132547|P2|Participant Flow|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally"
651064|NCT01132547|P1|Participant Flow|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally"
651065|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally"
651066|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally"
651067|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally"
651068|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally"
651069|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally"
651070|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally"
651071|NCT01132547|E2|Reported Event|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally"
651118|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
651072|NCT01132547|E1|Reported Event|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally"
651073|NCT01132651|B3|Baseline|Total|Total of all reporting groups
651074|NCT01132651|B2|Baseline|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
651075|NCT01132651|B1|Baseline|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
651076|NCT01132651|P2|Participant Flow|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
651077|NCT01132651|P1|Participant Flow|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
651078|NCT01132651|O2|Outcome|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
651079|NCT01132651|O1|Outcome|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
651080|NCT01132651|O2|Outcome|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
651081|NCT01132651|O1|Outcome|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
651082|NCT01132651|E2|Reported Event|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
651083|NCT01132651|E1|Reported Event|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
651084|NCT01132664|B6|Baseline|Total|Total of all reporting groups
651085|NCT01132664|B5|Baseline|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
651086|NCT01132664|B4|Baseline|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
651087|NCT01132664|B3|Baseline|Phase II - 100mg|Patients in the phase II only expansion cohort who received 100 mg of buparlisib - investigational drug
651092|NCT01132664|P3|Participant Flow|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib dose escalation were included in phase II and received 100 mg of investigational drug - buparsilib
651093|NCT01132664|P2|Participant Flow|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
651094|NCT01132664|P1|Participant Flow|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
651095|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
651096|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
651097|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
651098|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
651099|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
651100|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
651101|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
651102|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
651103|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
651104|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
651105|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
651106|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
651107|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
651108|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
651109|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
651110|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
651111|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
651112|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
651113|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
651114|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
651115|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
651116|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
651119|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
651120|NCT01132664|E5|Reported Event|BM Cohort 100 mg/Day|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
651121|NCT01132664|E4|Reported Event|BM Cohort 80 mg/Day|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
651122|NCT01132664|E3|Reported Event|Phase II Dose Expansion 100 mg/Day|Patients in the phase II expansion + patients from phase Ib dose escalation who received 100 mg/day of buparlisib - investigational drug
651123|NCT01132664|E2|Reported Event|Phase Ib Dose Escalation 100 mg/Day|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
651124|NCT01132664|E1|Reported Event|Phase Ib Dose Escalation 50 mg/Day|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug.
651125|NCT01132690|B3|Baseline|Total|Total of all reporting groups
651126|NCT01132690|B2|Baseline|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651127|NCT01132690|B1|Baseline|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651128|NCT01132690|P2|Participant Flow|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651129|NCT01132690|P1|Participant Flow|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651130|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651131|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651132|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651133|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651134|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651135|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651136|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651137|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651138|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651139|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651140|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651141|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
651144|NCT01132820|B1|Baseline|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
651145|NCT01132820|P1|Participant Flow|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
651146|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
651147|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
651148|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
651149|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
651150|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
651151|NCT01132820|O1|Outcome|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
651152|NCT01132820|E1|Reported Event|Cediranib|Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
651153|NCT01132846|B4|Baseline|Total|Total of all reporting groups
651154|NCT01132846|B3|Baseline|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651155|NCT01132846|B2|Baseline|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651156|NCT01132846|B1|Baseline|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651240|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651157|NCT01132846|P3|Participant Flow|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651158|NCT01132846|P2|Participant Flow|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651159|NCT01132846|P1|Participant Flow|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651160|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651161|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651162|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651163|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651164|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651165|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651166|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651167|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
653064|NCT01135368|O1|Outcome|Missing Data|Participants with no data at Baseline.
651168|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651169|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651170|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651171|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651172|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651173|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651174|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651175|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651176|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651177|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651178|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
652974|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
651179|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651180|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651181|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651182|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651183|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651184|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651185|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651186|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651187|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651188|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651189|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651190|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651191|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651192|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651193|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651194|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651195|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651196|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651197|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651198|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651199|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651200|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651322|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
651201|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651202|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651203|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651204|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651205|NCT01132846|E3|Reported Event|Low Dose Nesiritide|"Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
651206|NCT01132846|E2|Reported Event|Placebo|"Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
651207|NCT01132846|E1|Reported Event|Low Dose Dopamine|"Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
651208|NCT01133171|B4|Baseline|Total|Total of all reporting groups
651209|NCT01133171|B3|Baseline|Control|
651210|NCT01133171|B2|Baseline|Nurse Alone|
651211|NCT01133171|B1|Baseline|Dashboard Plus Nurse|
651212|NCT01133171|P3|Participant Flow|Control|
651213|NCT01133171|P2|Participant Flow|Nurse Alone|
651214|NCT01133171|P1|Participant Flow|Dashboard Plus Nurse|
651215|NCT01133171|O3|Outcome|Control|
651216|NCT01133171|O2|Outcome|Nurse Alone|
651217|NCT01133171|O1|Outcome|Dashboard Plus Nurse|
651218|NCT01133171|O2|Outcome|Nurse Alone|
651219|NCT01133171|O1|Outcome|Dashboard Plus Nurse|
651220|NCT01133171|E3|Reported Event|Control|
651221|NCT01133171|E2|Reported Event|Nurse Alone|
651222|NCT01133171|E1|Reported Event|Dashboard Plus Nurse|
651223|NCT01124604|B3|Baseline|Total|Total of all reporting groups
652314|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
651224|NCT01124604|B2|Baseline|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651225|NCT01124604|B1|Baseline|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651226|NCT01124604|P2|Participant Flow|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651227|NCT01124604|P1|Participant Flow|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651228|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651229|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651230|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651231|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651232|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651233|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651234|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651235|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651236|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651237|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651238|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651239|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651408|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651241|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651242|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651243|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651244|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651245|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651246|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651247|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651248|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651249|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651250|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651251|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651252|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651253|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651254|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651255|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651256|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651257|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651258|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651259|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651260|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651261|NCT01124604|E2|Reported Event|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651262|NCT01124604|E1|Reported Event|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
651263|NCT01124617|B3|Baseline|Total|Total of all reporting groups
651264|NCT01124617|B2|Baseline|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651265|NCT01124617|B1|Baseline|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651266|NCT01124617|P2|Participant Flow|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651267|NCT01124617|P1|Participant Flow|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651268|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651269|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651270|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651271|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651272|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651273|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651274|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651627|NCT01125605|O2|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
651275|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651276|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651277|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651278|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651279|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651280|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651281|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651282|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651283|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651284|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651285|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651286|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651287|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651288|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651289|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651290|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651291|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651292|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651390|NCT01124864|P1|Participant Flow|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651293|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651294|NCT01124617|E2|Reported Event|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
651295|NCT01124617|E1|Reported Event|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
651296|NCT01124643|B1|Baseline|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
651297|NCT01124643|P1|Participant Flow|Replagal® (0.2 mg/kg)|Replagal 0.2 milligram per kilogram (mg/kg) intravenously (IV), every other week (EOW).
651298|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
651299|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
651300|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
651301|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
651302|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
651303|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
651304|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
651305|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
651306|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
651307|NCT01124643|E1|Reported Event|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
651308|NCT01124786|B3|Baseline|Total|Total of all reporting groups
651309|NCT01124786|B2|Baseline|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
651310|NCT01124786|B1|Baseline|Gemcitabine Elaidate|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
651311|NCT01124786|P2|Participant Flow|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
651312|NCT01124786|P1|Participant Flow|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
651313|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
651314|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
651315|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
651316|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
651317|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
651318|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
651319|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
651320|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
651321|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
651323|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
651324|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
651325|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
651326|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
651327|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
651328|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
651329|NCT01124786|E2|Reported Event|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
651330|NCT01124786|E1|Reported Event|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
651331|NCT01124838|B3|Baseline|Total|Total of all reporting groups
651332|NCT01124838|B2|Baseline|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651333|NCT01124838|B1|Baseline|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651334|NCT01124838|P2|Participant Flow|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651335|NCT01124838|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651336|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651391|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
651337|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651338|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651339|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651340|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651341|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651342|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651343|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651344|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651345|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651409|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651346|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651347|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651348|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651349|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651350|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651351|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651352|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651392|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
651393|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
651394|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
651395|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
651353|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651354|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651355|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651356|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651357|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651358|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651359|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651360|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651361|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651362|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651444|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
651363|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651364|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651365|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651366|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651367|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651368|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651369|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651370|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651371|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651372|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651373|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651374|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651375|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651376|NCT01124838|E2|Reported Event|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651377|NCT01124838|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
651378|NCT01124864|B7|Baseline|Total|Total of all reporting groups
651379|NCT01124864|B6|Baseline|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651380|NCT01124864|B5|Baseline|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651445|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
651446|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
651381|NCT01124864|B4|Baseline|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651382|NCT01124864|B3|Baseline|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651383|NCT01124864|B2|Baseline|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
651384|NCT01124864|B1|Baseline|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651385|NCT01124864|P6|Participant Flow||For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651386|NCT01124864|P5|Participant Flow|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651387|NCT01124864|P4|Participant Flow|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651388|NCT01124864|P3|Participant Flow|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651389|NCT01124864|P2|Participant Flow|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
651397|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651398|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651399|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651400|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651401|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
651402|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651403|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651404|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651405|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651406|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651407|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
651410|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651411|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651412|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651413|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
651414|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651415|NCT01124864|E6|Reported Event||For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651416|NCT01124864|E5|Reported Event|Modified EGFR Mutant|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI.Patients received AUY922 at 70 mg/m^2 weekly infusions.
651417|NCT01124864|E4|Reported Event|EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651418|NCT01124864|E3|Reported Event|KRAS and EGFR Wild Type|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651419|NCT01124864|E2|Reported Event|EGFR Mutant|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
651420|NCT01124864|E1|Reported Event|KRAS Mutant|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
651421|NCT01124916|B3|Baseline|Total|Total of all reporting groups
651422|NCT01124916|B2|Baseline|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
651423|NCT01124916|B1|Baseline|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
651424|NCT01124916|P2|Participant Flow|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
651425|NCT01124916|P1|Participant Flow|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
651426|NCT01124916|O2|Outcome|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
651427|NCT01124916|O1|Outcome|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
651428|NCT01124916|O2|Outcome|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
651429|NCT01124916|O1|Outcome|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
651430|NCT01124916|E2|Reported Event|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
651431|NCT01124916|E1|Reported Event|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
651432|NCT01124955|B3|Baseline|Total|Total of all reporting groups
651433|NCT01124955|B2|Baseline|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
651434|NCT01124955|B1|Baseline|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
651435|NCT01124955|P2|Participant Flow|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
651436|NCT01124955|P1|Participant Flow|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
651437|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
651438|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
651439|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
651440|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
651441|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
651442|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
651443|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
651447|NCT01124955|E2|Reported Event|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
651448|NCT01124955|E1|Reported Event|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
651449|NCT01125098|B3|Baseline|Total|Total of all reporting groups
651450|NCT01125098|B2|Baseline|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
651451|NCT01125098|B1|Baseline|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.
PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection
continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability
stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability
stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
651452|NCT01125098|P2|Participant Flow|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
651453|NCT01125098|P1|Participant Flow|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.
PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection
continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability
stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability
stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
651454|NCT01125098|O2|Outcome|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
651455|NCT01125098|O1|Outcome|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.
PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection
continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability
stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability
stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
651456|NCT01125098|E2|Reported Event|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
651457|NCT01125098|E1|Reported Event|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.
PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection
continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability
stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability
stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
651458|NCT01125189|B4|Baseline|Total|Total of all reporting groups
651459|NCT01125189|B3|Baseline|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
651460|NCT01125189|B2|Baseline|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651461|NCT01125189|B1|Baseline|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651462|NCT01125189|P3|Participant Flow|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
651477|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
651463|NCT01125189|P2|Participant Flow|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651464|NCT01125189|P1|Participant Flow|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651465|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
651466|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651467|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651468|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
651469|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651536|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651470|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651471|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylate-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
651472|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651473|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651474|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
651475|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651476|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651516|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651478|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651479|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651480|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
651481|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651482|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651483|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
651484|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651485|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
651486|NCT01125189|E3|Reported Event|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
651487|NCT01125189|E2|Reported Event|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol.
651488|NCT01125189|E1|Reported Event|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol.
651489|NCT01125202|B3|Baseline|Total|Total of all reporting groups
651490|NCT01125202|B2|Baseline|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651491|NCT01125202|B1|Baseline|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651517|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651518|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651492|NCT01125202|P2|Participant Flow|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651493|NCT01125202|P1|Participant Flow|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651494|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651495|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651496|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651537|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651538|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651539|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651497|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651498|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651499|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651500|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651501|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651502|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651515|NCT01125514|P1|Participant Flow|Furosemide (Fu) /Fu+Aliskiren(Alis)150mg/fu+Alis 300mg|"Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.
Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.
Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.
Day 28, no study treatment."
651503|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651504|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651505|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651506|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651507|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651508|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651509|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651510|NCT01125202|O2|Outcome|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651511|NCT01125202|O1|Outcome|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651512|NCT01125202|E2|Reported Event|Attention Control|"Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period."
651513|NCT01125202|E1|Reported Event|Intervention|"Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues."
651514|NCT01125514|B1|Baseline|Furosemide (Fu) /Fu+Aliskiren(Alis)150mg/fu+Alis 300mg|"Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.
Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.
Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.
Day 28, no study treatment."
651519|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651520|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651521|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651522|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651523|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651524|NCT01125514|O3|Outcome|Furosemide go mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651525|NCT01125514|O2|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651526|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651527|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651528|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651529|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651530|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651531|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651532|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651533|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651534|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651535|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651540|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651541|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651542|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651543|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651544|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651545|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651546|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651547|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651548|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651549|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651550|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651551|NCT01125514|O4|Outcome|Furosemide 60 mg+ Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651552|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651553|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651554|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651555|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651556|NCT01125514|O3|Outcome|Furosemide 60 mg+ Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651557|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651558|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651559|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651560|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651561|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651562|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651563|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651564|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651565|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651566|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651567|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651568|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651569|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651570|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651571|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651572|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651573|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651574|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651575|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651576|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651577|NCT01125514|O2|Outcome|Furosemide 60 mg+ Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651578|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651579|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
651580|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
651581|NCT01125514|O2|Outcome|Furosemide 60 mg+ Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
651582|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
651583|NCT01125514|E3|Reported Event|60 mg Furosemide + 300 mg Aliskiren + 150 mg Placebo|60 mg furosemide + 300 mg aliskiren + 150 mg placebo
651584|NCT01125514|E2|Reported Event|60 mg Furosemide + 150 mg Aliskiren + 300 mg Placebo|60 mg furosemide + 150 mg aliskiren + 300 mg placebo
651585|NCT01125514|E1|Reported Event|60 mg Furosemide + 150 mg Placebo + 300 mg Placebo|60 mg furosemide + 150 mg placebo + 300 mg placebo
651586|NCT01125566|B3|Baseline|Total|Total of all reporting groups
651587|NCT01125566|B2|Baseline|Trastuzumab + Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
651588|NCT01125566|B1|Baseline|Afatinib + Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
651589|NCT01125566|P3|Participant Flow|AV Switched to TV|This group describes patients who crossed over from AV to TV following DMC recommendation to terminate recruitment on 26Apr2013. Patients discontinued AV and switched to TV if they were without disease progression on Afatinib+ Vinorelbine treatment on 26Apr2013.
651590|NCT01125566|P2|Participant Flow|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
651591|NCT01125566|P1|Participant Flow|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
651592|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
651623|NCT01125605|O2|Outcome|> = 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration >= 4 weeks
651593|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
651594|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
651595|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
651596|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
651597|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
651598|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
651599|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
651600|NCT01125566|E3|Reported Event|AV Switched to TV|This group describes patients who crossed over from AV to TV following DMC recommendation to terminate recruitment on 26Apr2013. Patients discontinued AV and switched to TV if they were without disease progression on Afatinib+ Vinorelbine treatment on 26Apr2013.
651601|NCT01125566|E2|Reported Event|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
651602|NCT01125566|E1|Reported Event|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
651603|NCT01125605|B1|Baseline|Observational Group|Pasconal Nerventropfen
651604|NCT01125605|P1|Participant Flow|Observational Group|Pasconal Nerventropfen PASCONAL® NERVENTROPFEN is a homoeopathic combination product (oral drops) consisting out of 4 ingredients: Avena sativa, Valeriana, Ignatia and Tarantula.
651605|NCT01125605|O2|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 3
651606|NCT01125605|O1|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
651607|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
651608|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 1
651609|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
651610|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
651611|NCT01125605|O2|Outcome|>= 4 Weeks|Observational group (Pasconal Nerventropfen) without concomitant medication
651612|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with concomitant medication
651613|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
651614|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 1
651615|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
651616|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
651617|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
651618|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
651619|NCT01125605|O2|Outcome|> = 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration >= 4 weeks
651620|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration < 4 weeks
651621|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
651622|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
651629|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
651630|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 3
651631|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
651632|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
651633|NCT01125605|E1|Reported Event|Observational Group|Pasconal Nerventropfen
651634|NCT01125722|B3|Baseline|Total|Total of all reporting groups
651635|NCT01125722|B2|Baseline|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
651636|NCT01125722|B1|Baseline|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
651637|NCT01125722|P2|Participant Flow|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
651638|NCT01125722|P1|Participant Flow|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
651639|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
651640|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
651641|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
651642|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
651643|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
651644|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
651645|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
651646|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
651647|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
651648|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
651649|NCT01125722|E2|Reported Event|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
651650|NCT01125722|E1|Reported Event|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
651651|NCT01125748|B3|Baseline|Total|Total of all reporting groups
651652|NCT01125748|B2|Baseline|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
651709|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
653123|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
651653|NCT01125748|B1|Baseline|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
651654|NCT01125748|P2|Participant Flow|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
651655|NCT01125748|P1|Participant Flow|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
651656|NCT01125748|O2|Outcome|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
651657|NCT01125748|O1|Outcome|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
651658|NCT01125748|O2|Outcome|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
651659|NCT01125748|O1|Outcome|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
651660|NCT01125748|E2|Reported Event|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
651661|NCT01125748|E1|Reported Event|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
651662|NCT01125774|B3|Baseline|Total|Total of all reporting groups
651663|NCT01125774|B2|Baseline|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651664|NCT01125774|B1|Baseline|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651665|NCT01125774|P4|Participant Flow|Placebo - Duplicate Participants|Participants who were randomized at more than 1 study site and each time were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651690|NCT01125800|B5|Baseline|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
652247|NCT01126671|O1|Outcome|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
651666|NCT01125774|P3|Participant Flow|Telcagepant 140 mg - Duplicate Participants|Participants who were randomized at more than 1 study site and were randomized at least once to telcagepant and may also have been randomized to placebo. Study drug was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651667|NCT01125774|P2|Participant Flow|Placebo - Excluding Duplicate Participants|Participants who were randomized at only 1 study site and were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651668|NCT01125774|P1|Participant Flow|Telcagepant 140 mg - Excluding Duplicate Participants|Participants who were randomized at only 1 study site and were randomized to telcagepant. Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651669|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651670|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651671|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651672|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651673|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651674|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651675|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651710|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
651676|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651677|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651678|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651679|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651680|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651681|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651682|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651683|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651684|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651685|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651686|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651687|NCT01125774|E2|Reported Event|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651688|NCT01125774|E1|Reported Event|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
651689|NCT01125800|B6|Baseline|Total|Total of all reporting groups
651691|NCT01125800|B4|Baseline|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
651692|NCT01125800|B3|Baseline|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
651693|NCT01125800|B2|Baseline|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
651694|NCT01125800|B1|Baseline|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
651695|NCT01125800|P5|Participant Flow|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
651696|NCT01125800|P4|Participant Flow|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route. The Phase I , Phase II patients are pooled and summarized by dose levels. One pediatric patient enrolled in the Phase II portion at the 680 mg/m2 dose was pooled with 21 pediatric patients enrolled in Phase I at the same dose
651697|NCT01125800|P3|Participant Flow|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
651698|NCT01125800|P2|Participant Flow|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
651699|NCT01125800|P1|Participant Flow|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
651700|NCT01125800|O2|Outcome|Adult Participants|All adult Participants were treated with sonidegib 800 mg once daily in phase II portion of the study. Pediatric patients were also enrolled in phase II portion of the study at the recommended phase II pediatric dose - 680 mg/m^2
651701|NCT01125800|O1|Outcome|Pediatric Participants|All the pediatric Participants were treated with LDE225 dose determined in the Phase I (233, 372, 425 and 680 mg/m^2).
651702|NCT01125800|O5|Outcome|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
651703|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
651704|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
651705|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
651706|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
651707|NCT01125800|O1|Outcome|Pediatric Participants|All the pediatric Participants were treated with LDE225 dose determined in the Phase I (233, 372, 425 and 680 mg/m^2).
651708|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
651711|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
651712|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
651713|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
651714|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
651715|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
651716|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
651717|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
651718|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
651719|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
651720|NCT01125800|O5|Outcome|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
651721|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
651722|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
651723|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
651724|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
651725|NCT01125800|O1|Outcome|All Participants|All participants received LDE225 233, 372, 425, 680, 800 mg/m^2 once daily through oral route until disease progression, unacceptable toxicity, or consent withdrawal.
651726|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
651727|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
651728|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
651729|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
651730|NCT01125800|E5|Reported Event|Adult Participants, LDE225 800 mg|Adult participants were treated with LDE225 800 mg capsule once daily.
651731|NCT01125800|E4|Reported Event|Pediatric Participants, LDE225 680 mg/m^2|Pediatric participants received LDE225 680 mg/m^2 once daily through oral route.
651732|NCT01125800|E3|Reported Event|Pediatric Participants, LDE225 425 mg/m^2|Pediatric participants received LDE225 425 mg/m^2 once daily through oral route.
651733|NCT01125800|E2|Reported Event|Pediatric Participants, LDE225 372 mg/m^2|Pediatric participants received LDE225 372 mg/m^2 once daily through oral route.
651734|NCT01125800|E1|Reported Event|Pediatric Participants, LDE225 233 mg/m^2|Pediatric participants received LDE225 233 mg/m^2 once daily through oral route.
651735|NCT01125813|B1|Baseline|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
651736|NCT01125813|P1|Participant Flow|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
651737|NCT01125813|O1|Outcome|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
651738|NCT01125813|O1|Outcome|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
651739|NCT01125813|E1|Reported Event|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
651740|NCT01125917|B1|Baseline|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
651741|NCT01125917|P1|Participant Flow|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
651742|NCT01125917|O1|Outcome|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
651743|NCT01125917|E1|Reported Event|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
651744|NCT01125930|B3|Baseline|Total|Total of all reporting groups
651745|NCT01125930|B2|Baseline|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651746|NCT01125930|B1|Baseline|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651747|NCT01125930|P2|Participant Flow|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651748|NCT01125930|P1|Participant Flow|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651902|NCT01126060|B2|Baseline|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
652315|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
651749|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651750|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651751|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651752|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651753|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651754|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651755|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651756|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651757|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651758|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651759|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651760|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651761|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651762|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651763|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651764|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651765|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
653556|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
651766|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651767|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651768|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651769|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651770|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651771|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651772|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651773|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651774|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
652975|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
651775|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651776|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651777|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651778|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651779|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651780|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651781|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651782|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651783|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651784|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651785|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651786|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651787|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651788|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651789|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651790|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651791|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
652976|NCT01135017|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
651792|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651793|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651794|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651795|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651796|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651797|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651798|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651799|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651800|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651801|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651802|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651803|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651804|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651805|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651806|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651807|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651808|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
652977|NCT01135017|E1|Reported Event|Placebo|Placebo (for dronedarone) twice a day for 12 weeks
651809|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651810|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651811|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651812|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651813|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651814|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651815|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651816|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651817|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651818|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651819|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651820|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651821|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651822|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651823|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651824|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651825|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
652978|NCT01135069|B4|Baseline|Total|Total of all reporting groups
651826|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651827|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651828|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651829|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651830|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651831|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651832|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651833|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651834|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651835|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651836|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651837|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651838|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651839|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651840|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651841|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651842|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651922|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Prazosin: 4 mg capsules twice daily for 12 weeks"
651843|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651844|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651845|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651846|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651847|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651848|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651849|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651903|NCT01126060|B1|Baseline|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
651904|NCT01126060|P2|Participant Flow|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
651850|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651851|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651852|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651853|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651854|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651855|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651856|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651857|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651858|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651859|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
652248|NCT01126671|E2|Reported Event|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
651860|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651861|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651862|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651863|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651864|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651865|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651866|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651867|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651868|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651869|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651870|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651871|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651872|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651873|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651874|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651875|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651876|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
652979|NCT01135069|B3|Baseline|Placebo|Microsphere Gel no active
651877|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651878|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651879|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651880|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651881|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651882|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651883|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651884|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651885|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651886|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651887|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651888|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651889|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651890|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651891|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651892|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651893|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
652980|NCT01135069|B2|Baseline|Brand|Retin-A Micro 0.1%
651894|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651895|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651896|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651897|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651898|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651899|NCT01125930|E2|Reported Event|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
651900|NCT01125930|E1|Reported Event|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
651901|NCT01126060|B3|Baseline|Total|Total of all reporting groups
651905|NCT01126060|P1|Participant Flow|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
651906|NCT01126060|O2|Outcome|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
651907|NCT01126060|O1|Outcome|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
651908|NCT01126060|E2|Reported Event|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
651909|NCT01126060|E1|Reported Event|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
651910|NCT01126099|B3|Baseline|Total|Total of all reporting groups
651911|NCT01126099|B2|Baseline|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Placebo: Placebo capsules twice daily for 12 weeks"
651912|NCT01126099|B1|Baseline|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Prazosin: 4 mg capsules twice daily for 12 weeks"
651913|NCT01126099|P2|Participant Flow|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Placebo: Placebo capsules twice daily for 12 weeks"
651914|NCT01126099|P1|Participant Flow|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Prazosin: 4 mg capsules twice daily for 12 weeks"
651915|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Placebo: Placebo capsules twice daily for 12 weeks"
651916|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Prazosin: 4 mg capsules twice daily for 12 weeks"
651917|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Placebo: Placebo capsules twice daily for 12 weeks"
651918|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Prazosin: 4 mg capsules twice daily for 12 weeks"
651919|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Placebo: Placebo capsules twice daily for 12 weeks"
651920|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Prazosin: 4 mg capsules twice daily for 12 weeks"
651921|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Placebo: Placebo capsules twice daily for 12 weeks"
651923|NCT01126099|E2|Reported Event|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Placebo: Placebo capsules twice daily for 12 weeks"
651924|NCT01126099|E1|Reported Event|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Prazosin: 4 mg capsules twice daily for 12 weeks"
651925|NCT01126268|B1|Baseline|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651926|NCT01126268|P1|Participant Flow|Retapamulin Ointment 1% Group|Subjects with clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic were screened, and if qualified, they received topical retapamulin ointment 1% twice daily for 5 days.
651927|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651928|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651929|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651930|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651931|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651932|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651933|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651934|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651935|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651936|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651937|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651938|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651939|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651940|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651941|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651942|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651943|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651944|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651945|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651946|NCT01126268|E1|Reported Event|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
651947|NCT01126359|B1|Baseline|All Study Participants|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa.
651948|NCT01126359|P2|Participant Flow|Placebo-Saline Then Lidocaine|Control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube. Then, interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
651949|NCT01126359|P1|Participant Flow|Lidocaine Then Placebo-Saline|Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge. Then, control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube.
651950|NCT01126359|O3|Outcome|Lidocaine Minus Placebo-Saline Difference|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Each patient narcotic requirements are determined at each measured time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline difference (mg). A negative narcotic requirement difference indicates a reduction in medication dosed (mg) used during and after VAC dressing change in a crossover intervention technique.
651951|NCT01126359|O2|Outcome|Placebo-Saline|All patients who received placebo-saline prior to VAC dressing change.
651952|NCT01126359|O1|Outcome|Lidocaine|All patients who received lidocaine prior to VAC dressing change.
651953|NCT01126359|O3|Outcome|Lidocaine Minus Placebo-Saline Difference|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline VAS difference for each participant. A negative VAS difference indicates a reduction in the level of pain with Lidocaine compared to Placebo-Saline utilizing crossover intervention.
651954|NCT01126359|O2|Outcome|Placebo-Saline|All patients who received placebo-saline prior to VAC dressing change.
651955|NCT01126359|O1|Outcome|Lidocaine|All patients who received lidocaine prior to VAC dressing change.
651956|NCT01126359|E4|Reported Event|Second Intervention (Lidocaine)|
651957|NCT01126359|E3|Reported Event|Second Intervention (Placebo)|
651958|NCT01126359|E2|Reported Event|First Intervention (Placebo)|
651959|NCT01126359|E1|Reported Event|First Intervention (Lidocaine)|
651960|NCT01126424|B7|Baseline|Total|Total of all reporting groups
651961|NCT01126424|B6|Baseline|Placebo / Oxybutynin / Solifenacin|Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
651962|NCT01126424|B5|Baseline|Placebo / Solifenacin / Oxybutynin|Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
651963|NCT01126424|B4|Baseline|Oxybutynin / Solifenacin / Placebo|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
651964|NCT01126424|B3|Baseline|Oxybutynin / Placebo / Solifenacin|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
651965|NCT01126424|B2|Baseline|Solifenacin / Placebo / Oxybutynin|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
651966|NCT01126424|B1|Baseline|Solifenacin / Oxybutynin / Placebo|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
651967|NCT01126424|P6|Participant Flow|Placebo / Oxybutynin / Solifenacin|Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
651968|NCT01126424|P5|Participant Flow|Placebo / Solifenacin / Oxybutynin|Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
651969|NCT01126424|P4|Participant Flow|Oxybutynin / Solifenacin / Placebo|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
651970|NCT01126424|P3|Participant Flow|Oxybutynin / Placebo / Solifenacin|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
651971|NCT01126424|P2|Participant Flow|Solifenacin / Placebo / Oxybutynin|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
651972|NCT01126424|P1|Participant Flow|Solifenacin / Oxybutynin / Placebo|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
651973|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
651974|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
651975|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
651976|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
651977|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
651978|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
651980|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
651981|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
651982|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
651983|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
651984|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
651985|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
651986|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
651987|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
651988|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
651989|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
651990|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
651991|NCT01126424|E3|Reported Event|Placebo|Participants received 21 days of treatment with placebo.
651992|NCT01126424|E2|Reported Event|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
651993|NCT01126424|E1|Reported Event|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
651994|NCT01126437|B4|Baseline|Total|Total of all reporting groups
651995|NCT01126437|B3|Baseline|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 18 mcg: HandiHaler"
651996|NCT01126437|B2|Baseline|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
651997|NCT01126437|B1|Baseline|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
651998|NCT01126437|P3|Participant Flow|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 18 mcg: HandiHaler"
651999|NCT01126437|P2|Participant Flow|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
652000|NCT01126437|P1|Participant Flow|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
652001|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 18 mcg: HandiHaler"
652002|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
652249|NCT01126671|E1|Reported Event|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
652003|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
652004|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 18 mcg: HandiHaler"
652005|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
652006|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
652007|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 18 mcg: HandiHaler"
652008|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
652009|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
652010|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 18 mcg: HandiHaler"
652011|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
652012|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
652013|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 18 mcg: HandiHaler"
652014|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
652015|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
652016|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 18 mcg: HandiHaler"
652017|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
652018|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
652019|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 18 mcg: HandiHaler"
652020|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
652521|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652021|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
652022|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 18 mcg: HandiHaler"
652023|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
652024|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
652025|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 18 mcg: HandiHaler"
652026|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
652027|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
652028|NCT01126437|E3|Reported Event|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
Tiotropium 18 mcg: HandiHaler"
652029|NCT01126437|E2|Reported Event|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
652030|NCT01126437|E1|Reported Event|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
652031|NCT01126541|B4|Baseline|Total|Total of all reporting groups
652032|NCT01126541|B3|Baseline|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
652033|NCT01126541|B2|Baseline|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652034|NCT01126541|B1|Baseline|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652035|NCT01126541|P3|Participant Flow|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
652036|NCT01126541|P2|Participant Flow|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652037|NCT01126541|P1|Participant Flow|Randomized Retreatment Arm A: Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg intravenously (IV) on Days 1 and 15. After Week 24, if Disease Activity Score based on 28-Joint Count (DAS28) was greater than (>)3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and methotrexate (MTX) ≥10 milligrams per week (mg/week) by mouth or parenteral throughout course of treatment.
652038|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652039|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652040|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652041|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652042|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652043|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652044|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652045|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652046|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652047|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652048|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652049|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652050|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652051|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652052|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652053|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652132|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652054|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652055|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652056|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652057|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652058|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652059|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652060|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652061|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652313|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652062|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652063|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652064|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652065|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652066|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652067|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652068|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652069|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652070|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652133|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652250|NCT01126723|B3|Baseline|Total|Total of all reporting groups
652071|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652072|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652073|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652074|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652075|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652076|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652077|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652078|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652079|NCT01126541|O1|Outcome|Randomized Re-treatment Arm A: Single 1000 mg IV Rituximab|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652080|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652081|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652082|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652083|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652084|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652085|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652086|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652087|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652088|NCT01126541|O2|Outcome|Nonrandomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
652981|NCT01135069|B1|Baseline|Generic|Tretinoin Microsphere Gel 0.1%
652089|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652090|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652091|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652092|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652093|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652094|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652095|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652148|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652096|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652097|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652098|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652099|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652100|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652101|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652102|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652103|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652104|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652105|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652982|NCT01135069|P3|Participant Flow|Placebo|Microsphere Gel no active
652106|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652107|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652108|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652109|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652110|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652111|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652112|NCT01126541|O2|Outcome|Nonrandomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
652149|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652113|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652114|NCT01126541|E3|Reported Event|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
652115|NCT01126541|E2|Reported Event|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
652116|NCT01126541|E1|Reported Event|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
652117|NCT01126580|B4|Baseline|Total|Total of all reporting groups
652118|NCT01126580|B3|Baseline|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652119|NCT01126580|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652120|NCT01126580|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652121|NCT01126580|P3|Participant Flow|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652122|NCT01126580|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652123|NCT01126580|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652124|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652125|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652126|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652127|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652128|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652129|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652130|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652131|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652246|NCT01126671|O2|Outcome|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
652134|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652135|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652136|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652137|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652138|NCT01126580|O1|Outcome|1.5 mg or 0.75 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg, subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652139|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652140|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652141|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652142|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652143|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652144|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652145|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652146|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652147|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652150|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652151|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652152|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652153|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652154|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652155|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652156|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652157|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652158|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652159|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652160|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652161|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652162|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652163|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652164|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652165|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652166|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652167|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652168|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652169|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652170|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652983|NCT01135069|P2|Participant Flow|Brand|Retin-A Micro 0.1%
652171|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652172|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652173|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652174|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652175|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652176|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652177|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652178|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652179|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652180|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652181|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652182|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652183|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652184|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652185|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652186|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652187|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652188|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652189|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652190|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652191|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652192|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652193|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652194|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652195|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652196|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652197|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652198|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652199|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652200|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652201|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652202|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652203|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652204|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652205|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652206|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652207|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652984|NCT01135069|P1|Participant Flow|Generic|Tretinoin Microsphere Gel 0.1%
652208|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652209|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652210|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652211|NCT01126580|E3|Reported Event|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks
Placebo: subcutaneously (SC), once weekly for 52 weeks"
652212|NCT01126580|E2|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652213|NCT01126580|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks
Placebo: orally, twice daily for 52 weeks"
652214|NCT01126593|B4|Baseline|Total|Total of all reporting groups
652215|NCT01126593|B3|Baseline|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
652216|NCT01126593|B2|Baseline|Control Group|The control group patients will receive no continuous infusion catheter.
652217|NCT01126593|B1|Baseline|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
652218|NCT01126593|P3|Participant Flow|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
652219|NCT01126593|P2|Participant Flow|Control Group|The control group patients will receive no continuous infusion catheter.
652220|NCT01126593|P1|Participant Flow|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
652221|NCT01126593|O3|Outcome|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
652222|NCT01126593|O2|Outcome|Control Group|The control group patients will receive no continuous infusion catheter.
652223|NCT01126593|O1|Outcome|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
653557|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
652224|NCT01126593|E3|Reported Event|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
652225|NCT01126593|E2|Reported Event|Control Group|The control group patients will receive no continuous infusion catheter.
652226|NCT01126593|E1|Reported Event|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
652227|NCT01126619|B1|Baseline|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
652228|NCT01126619|P1|Participant Flow|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
652229|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
652230|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
652231|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
652232|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
652233|NCT01126619|O2|Outcome|Week 24|Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
652234|NCT01126619|O1|Outcome|Baseline|Baseline Static Physician Global Assessment of Psoriasis, prior to initiation of anti-TNF therapy.
652235|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
652236|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
652237|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
652238|NCT01126619|E1|Reported Event|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
652239|NCT01126671|B3|Baseline|Total|Total of all reporting groups
652240|NCT01126671|B2|Baseline|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
652241|NCT01126671|B1|Baseline|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
652242|NCT01126671|P2|Participant Flow|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
652243|NCT01126671|P1|Participant Flow|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
652244|NCT01126671|O2|Outcome|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
652245|NCT01126671|O1|Outcome|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
652251|NCT01126723|B2|Baseline|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
652252|NCT01126723|B1|Baseline|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
652253|NCT01126723|P2|Participant Flow|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
652254|NCT01126723|P1|Participant Flow|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
652255|NCT01126723|O2|Outcome|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
652256|NCT01126723|O1|Outcome|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
652257|NCT01126723|E2|Reported Event|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
652258|NCT01126723|E1|Reported Event|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
652259|NCT01126801|B3|Baseline|Total|Total of all reporting groups
652260|NCT01126801|B2|Baseline|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
652261|NCT01126801|B1|Baseline|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
652262|NCT01126801|P2|Participant Flow|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
652263|NCT01126801|P1|Participant Flow|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
652264|NCT01126801|O2|Outcome|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
652265|NCT01126801|O1|Outcome|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
652266|NCT01126801|E2|Reported Event|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
652267|NCT01126801|E1|Reported Event|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
652268|NCT01126957|B1|Baseline|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.
Ketamine: Ketamine was given as a 0.5mg / Kg bolus.
Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo
Propofol: Propofol given to both arms to maintain sedation throughout procedure."
652269|NCT01126957|P1|Participant Flow|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine or placebo infusion, followed by propofol to maintain sedation.
Ketamine: Ketamine was given as a 0.5mg / Kg bolus.
Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo
Propofol: Propofol given to both arms to maintain sedation throughout procedure."
652270|NCT01126957|O1|Outcome|Ketamine|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.
Ketamine: Ketamine was given as a 0.5mg / Kg bolus.
Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo
Propofol: Propofol given to both arms to maintain sedation throughout procedure."
652271|NCT01126957|O1|Outcome|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.
Ketamine: Ketamine was given as a 0.5mg / Kg bolus.
Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo
Propofol: Propofol given to both arms to maintain sedation throughout procedure."
652272|NCT01126957|E1|Reported Event|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or palcebo, followed by propofol to maintain sedation.
Ketamine: Ketamine was given as a 0.5mg / Kg bolus.
Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo
Propofol: Propofol given to both arms to maintain sedation throughout procedure."
652273|NCT01133275|B1|Baseline|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
652274|NCT01133275|P1|Participant Flow|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
652275|NCT01133275|O1|Outcome|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
652276|NCT01133275|O1|Outcome|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
652277|NCT01133275|E1|Reported Event|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
652278|NCT01133288|B1|Baseline|Yulex Glove|Yulex Glove Treatment
652279|NCT01133288|P1|Participant Flow|Yulex Glove|Yulex Glove Treatment
652280|NCT01133288|O1|Outcome|Yulex Glove|Yulex Glove Treatment
652281|NCT01133288|O1|Outcome|Yulex Glove|Yulex Glove Treatment
652282|NCT01133288|E1|Reported Event|Yulex Glove|Yulex Glove Treatment
652283|NCT01133379|B4|Baseline|Total|Total of all reporting groups
652284|NCT01133379|B3|Baseline|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652285|NCT01133379|B2|Baseline|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652286|NCT01133379|B1|Baseline|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652287|NCT01133379|P3|Participant Flow|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652288|NCT01133379|P2|Participant Flow|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652289|NCT01133379|P1|Participant Flow|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652290|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652291|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652292|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652293|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652294|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652295|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652296|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652297|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652298|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652299|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652300|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652301|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652302|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652303|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652304|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652305|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652306|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652307|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652308|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652309|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652310|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652311|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652312|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652316|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652317|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652318|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652319|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652320|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652321|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652322|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652323|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652324|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652325|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652326|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652327|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652328|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652329|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652330|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652331|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652332|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652333|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652334|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652335|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652336|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652337|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652338|NCT01133379|E3|Reported Event|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
652339|NCT01133379|E2|Reported Event|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
652340|NCT01133379|E1|Reported Event|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
652341|NCT01133392|B3|Baseline|Total|Total of all reporting groups
652342|NCT01133392|B2|Baseline|Insulin Lispro Dosing Sequence BABA|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence BABA.
652343|NCT01133392|B1|Baseline|Insulin Lispro Dosing Sequence ABAB|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence ABAB.
652344|NCT01133392|P2|Participant Flow|Insulin Lispro Dosing Sequence BABA|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence BABA. There was an interval of approximately 4 to 7 days between doses.
652345|NCT01133392|P1|Participant Flow|Insulin Lispro Dosing Sequence ABAB|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence ABAB. There was an interval of approximately 4 to 7 days between doses.
652346|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
652347|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
652348|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
652349|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
652350|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
652351|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
652352|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
652353|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
652354|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
652355|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
652356|NCT01133392|E2|Reported Event|Insulin Lispro B|Insulin lispro B formulation (Treatment B, reference – 2 occasions)
652357|NCT01133392|E1|Reported Event|Insulin Lispro A|Insulin lispro A formulation (Treatment A, test – 2 occasions)
652358|NCT01133418|B3|Baseline|Total|Total of all reporting groups
652359|NCT01133418|B2|Baseline|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.
Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
652395|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
652396|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652522|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652360|NCT01133418|B1|Baseline|Cognitive Training|"Computerized Progressive Attention Training
Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
652361|NCT01133418|P2|Participant Flow|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.
Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
652362|NCT01133418|P1|Participant Flow|Cognitive Training|"Computerized Progressive Attention Training
Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
652363|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.
Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
652364|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training
Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
652380|NCT01133522|B4|Baseline|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652985|NCT01135069|O3|Outcome|Placebo|"Treatment of acne for 12 weeks
Percent change (reduction) in acne lesions was 58% reduction"
652365|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.
Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
652366|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training
Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
652367|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.
Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
652368|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training
Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
652369|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.
Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
652370|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training
Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
652371|NCT01133418|E2|Reported Event|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.
Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
652372|NCT01133418|E1|Reported Event|Cognitive Training|"Computerized Progressive Attention Training
Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
652373|NCT01133522|B11|Baseline|Total|Total of all reporting groups
652374|NCT01133522|B10|Baseline|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652375|NCT01133522|B9|Baseline|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
652376|NCT01133522|B8|Baseline|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652377|NCT01133522|B7|Baseline|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
652378|NCT01133522|B6|Baseline|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
652379|NCT01133522|B5|Baseline|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
652381|NCT01133522|B3|Baseline|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
652382|NCT01133522|B2|Baseline|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
652383|NCT01133522|B1|Baseline|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
652384|NCT01133522|P10|Participant Flow|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652385|NCT01133522|P9|Participant Flow|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
652386|NCT01133522|P8|Participant Flow|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652387|NCT01133522|P7|Participant Flow|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
652388|NCT01133522|P6|Participant Flow|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks (Q4W) for 8 weeks.
652389|NCT01133522|P5|Participant Flow|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
652390|NCT01133522|P4|Participant Flow|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks (Q2W) for 6 weeks.
652391|NCT01133522|P3|Participant Flow|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
652392|NCT01133522|P2|Participant Flow|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly (QW) for 6 weeks.
652393|NCT01133522|P1|Participant Flow|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
652394|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
653558|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
652397|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
652398|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
652399|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
652400|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652401|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
652402|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
652403|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
652404|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652405|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
652406|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652407|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
652408|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
652409|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
652410|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652411|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
652412|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
652413|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
652414|NCT01133522|O7|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652415|NCT01133522|O6|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652416|NCT01133522|O5|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
652417|NCT01133522|O4|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
652418|NCT01133522|O3|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652419|NCT01133522|O2|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
652420|NCT01133522|O1|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
652421|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652422|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
652423|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652424|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
652425|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
652426|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
652427|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652428|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
652429|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
652430|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
652431|NCT01133522|O7|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652432|NCT01133522|O6|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
653559|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
652433|NCT01133522|O5|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
652434|NCT01133522|O4|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
652435|NCT01133522|O3|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652436|NCT01133522|O2|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
652437|NCT01133522|O1|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
652438|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652439|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
652440|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652441|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
652442|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
652443|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
652444|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652445|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
652446|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
652447|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
652448|NCT01133522|E10|Reported Event|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652449|NCT01133522|E9|Reported Event|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
652450|NCT01133522|E8|Reported Event|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652451|NCT01133522|E7|Reported Event|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
652452|NCT01133522|E6|Reported Event|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
652552|NCT01134276|O1|Outcome|PTBD|Final biliary drainage procedure: biliary drainage via PTBD
652453|NCT01133522|E5|Reported Event|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
652454|NCT01133522|E4|Reported Event|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
652455|NCT01133522|E3|Reported Event|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
652456|NCT01133522|E2|Reported Event|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
652457|NCT01133522|E1|Reported Event|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
652458|NCT01134042|B4|Baseline|Total|Total of all reporting groups
652459|NCT01134042|B3|Baseline|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652460|NCT01134042|B2|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652461|NCT01134042|B1|Baseline|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652462|NCT01134042|P3|Participant Flow|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652463|NCT01134042|P2|Participant Flow|FF/VI 200/25 µg OD|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652464|NCT01134042|P1|Participant Flow|FF 200 µg OD|Participants received FF 200 microgram (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening plus placebo via the DISKUS/ACCUHALER twice daily (BID), for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652465|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652466|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652467|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652468|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652469|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652470|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652471|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652472|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652473|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652474|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652475|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652476|NCT01134042|O1|Outcome|FF 200 µg OD Arm|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652477|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652478|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652479|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652480|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652481|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652482|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652483|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652484|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652485|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652486|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652487|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652488|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652489|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652490|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652491|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652492|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652493|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652494|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652495|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652496|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652497|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652498|NCT01134042|E3|Reported Event|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652499|NCT01134042|E2|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652500|NCT01134042|E1|Reported Event|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
652501|NCT01134081|B1|Baseline|CelTx™ & Free Gingival Grafts|CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate
652502|NCT01134081|P1|Participant Flow|CelTx™ & Free Gingival Grafts|CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate
652503|NCT01134081|O2|Outcome|Free Gingival Grafts|"Harvested tissue from palate
Free Gingival Graft: Harvested tissue from palate"
652504|NCT01134081|O1|Outcome|CelTx™|"Living bilayered cell therapy product
CelTx™: CelTx™ is a living bilayered cell therapy product. CelTx™ is constructed of Type I bovine collagen (extracted from bovine tendons and subsequently purified) and viable allogeneic human fibroblasts and keratinocytes isolated from human neonatal foreskin. This is applied once in the oral cavity."
652505|NCT01134081|O2|Outcome|Free Gingival Grafts|Harvested tissue from palate
652506|NCT01134081|O1|Outcome|CelTx™|Living bilayered cell therapy product
652507|NCT01134081|E2|Reported Event|Free Gingival Graft|Harvested tissue from palate
652508|NCT01134081|E1|Reported Event|CelTx™|Living bilayered cell therapy product
652509|NCT01134107|B3|Baseline|Total|Total of all reporting groups
652510|NCT01134107|B2|Baseline|Aspart 6D/Lispro 6D|Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
652511|NCT01134107|B1|Baseline|Lispro 6D/Aspart 6D|Insulin Lispro 6D administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.
652512|NCT01134107|P2|Participant Flow|Aspart 6D/Lispro 6D|Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
652513|NCT01134107|P1|Participant Flow|Lispro 6D/Aspart 6D|Insulin Lispro 6 Day (6D) administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.
652514|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652515|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652516|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652517|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652518|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652519|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652520|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652523|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652524|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652525|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652526|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652527|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652528|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652529|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652530|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652531|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652532|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652533|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652534|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652535|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652536|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652537|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652538|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652539|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652540|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652541|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652542|NCT01134107|E2|Reported Event|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
652543|NCT01134107|E1|Reported Event|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
652544|NCT01134276|B3|Baseline|Total|Total of all reporting groups
652545|NCT01134276|B2|Baseline|PTBD|final biliary drainage procedure : biliary drainage via PTBD
652546|NCT01134276|B1|Baseline|ERBD|final biliary drainage procedure: biliary drainage via ERBD/ENBD
652547|NCT01134276|P2|Participant Flow|PTBD|biliary drainage : biliary drainage via PTBD
652548|NCT01134276|P1|Participant Flow|ERBD|biliary drainage : biliary drainage via ERBD/ENBD
652549|NCT01134276|O2|Outcome|ERBD|Final biliary drainage procedure: biliary drainage via ERBD/ENBD
652550|NCT01134276|O1|Outcome|PTBD|Final biliary drainage procedure: biliary drainage via PTBD
652551|NCT01134276|O2|Outcome|ENBD/ERBD|Final biliary drainage procedure: biliary drainage via ENBD/ERBD
652555|NCT01134276|E2|Reported Event|ERBD|"final biliary drainage procedure: biliary drainage via ERBD/ENBD
Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting"
652556|NCT01134276|E1|Reported Event|PTBD|"final biliary drainage procedure: biliary drainage via PTBD
Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting"
652557|NCT01134315|B3|Baseline|Total|Total of all reporting groups
652558|NCT01134315|B2|Baseline|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
652559|NCT01134315|B1|Baseline|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
652560|NCT01134315|P2|Participant Flow|Calcitriol|Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
652561|NCT01134315|P1|Participant Flow|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
652562|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
652563|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
652564|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
652565|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
652566|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
652567|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
652568|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
652569|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
652570|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
652571|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
652572|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
652573|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
652574|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
652575|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
652576|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
652577|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
652578|NCT01134315|E2|Reported Event|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
652579|NCT01134315|E1|Reported Event|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
652580|NCT01134393|B1|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652581|NCT01134393|P1|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652582|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652583|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652584|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652585|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652586|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652587|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652588|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652589|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652590|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652591|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652592|NCT01134393|E2|Reported Event|T80/A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily
652593|NCT01134393|E1|Reported Event|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
652594|NCT01134510|B3|Baseline|Total|Total of all reporting groups
652619|NCT01134549|P1|Participant Flow|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
652595|NCT01134510|B2|Baseline|Placebo|Potential subjects will be identified after a review of medical records of patients under the care of one or more of the study investigators. Potential subjects will be identified and approached during an inpatient or outpatient clinical visit by a member of the research team. The Principal investigator (PI) I will explain what it means to be highly-sensitized and the risks associated with it. Then PI will describe the standard of care of Transplant Immunology Program (TIP) patients. After that PI will describe the study and explain the risks and benefits of participation. After the discussion, a copy of the consent form will be either emailed or faxed to the patient for review and consideration of study participation. The patient can contact the study team where they will have the opportunity to ask questions and then sign the Informed Consent Form (ICF), if interested.
652596|NCT01134510|B1|Baseline|C1 Esterase Inhibitor|"Potential subjects will be identified after a review of medical records of patients under the care of one or more of the study investigators. Potential subjects will be identified and approached during an inpatient or outpatient clinical visit by a member of the research team. The Principal investigator (PI) I will explain what it means to be highly-sensitized and the risks associated with it. The PI will describe the study and explain the risks and benefits of participation. After the discussion, a copy of the consent form will be emailed or faxed to the patient for review & consideration of study participation. The patient can contact the study team to ask questions and sign the Informed Consent Form (ICF), if interested.
C1 INH is dosed at 20 units per kg body weight and is administered by slow IV injection at a rate of approximately 4 mL per minute. Study patients will receive 20U/kg C1 INH vs placebo (0.9% NS) on days 0 and day 2, then twice weekly X 3 weeks."
652597|NCT01134510|P2|Participant Flow|Placebo|Patients will receive placebo (0.9% Normal Saline) on days 0 and day 2, then twice weekly for 3 weeks.
652598|NCT01134510|P1|Participant Flow|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, Complement 3 and Complement 4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 Units/kg C1 INH vs placebo (0.9% Normal Saline) on day 0 and day 2, then twice weekly X 3 weeks. A protocol biopsy will be performed at 6 month to assess the allograft for evidence of Antibody Mediated Rejection, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and Anibody Mediated Rejection episodes as well as Donor Specific Antibody. A protocol biopsy will be performed at 6 month.
652599|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
652600|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 Units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
652601|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
652602|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
652603|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
652604|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
652605|NCT01134510|O2|Outcome|Normal Saline|"10 subjects placebo in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 20 units/kg vs Placebo twice weekly x 4 weeks"
652606|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|"10 subjects will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.
C1 Esterase Inhibitor: C1 Esterase Inhibitor 20 units/kg vs Placebo twice weekly x 4 weeks"
652607|NCT01134510|E2|Reported Event|C1 Esterase Inhibitor|Total of 1 Serious Adverse Event (1/10 = 10%)
652608|NCT01134510|E1|Reported Event|Placebo|Total of 2 Serious Adverse Events (2/10 patients = 20%)
652609|NCT01134549|B6|Baseline|Total|Total of all reporting groups
652610|NCT01134549|B5|Baseline|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652611|NCT01134549|B4|Baseline|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652612|NCT01134549|B3|Baseline|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652613|NCT01134549|B2|Baseline|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652614|NCT01134549|B1|Baseline|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
652615|NCT01134549|P5|Participant Flow|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652616|NCT01134549|P4|Participant Flow|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652617|NCT01134549|P3|Participant Flow|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652618|NCT01134549|P2|Participant Flow|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652620|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652621|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652622|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652623|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652624|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652625|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652626|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652627|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652628|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652629|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652630|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652631|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652632|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652633|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652634|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652635|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652636|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652637|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652638|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652639|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652640|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652641|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652642|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652643|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652644|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652645|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652646|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652647|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652648|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652649|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652650|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652651|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652652|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652653|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652654|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652655|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652656|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652657|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652658|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652659|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652660|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
652661|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652662|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652663|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652664|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652665|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
652666|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652667|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652668|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652669|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652670|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
652671|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652672|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652673|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652674|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652675|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
652676|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652677|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652678|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652679|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652680|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
652681|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652682|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652683|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652684|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652685|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
652686|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652687|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652688|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652689|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652690|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
652691|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652692|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652693|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652694|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652695|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
652696|NCT01134549|E6|Reported Event|Etelcalcetide Pooled|Participants received a single dose of etelcalcetide administered by intravenous injection.
652697|NCT01134549|E5|Reported Event|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
652698|NCT01134549|E4|Reported Event|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
652699|NCT01134549|E3|Reported Event|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
652700|NCT01134549|E2|Reported Event|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
652701|NCT01134549|E1|Reported Event|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
652702|NCT01134614|B3|Baseline|Total|Total of all reporting groups
652703|NCT01134614|B2|Baseline|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
ipilimumab: Given IV"
652704|NCT01134614|B1|Baseline|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
ipilimumab: Given IV
sargramostim: Given SC"
652719|NCT01134627|P1|Participant Flow|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652705|NCT01134614|P2|Participant Flow|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
ipilimumab: Given IV"
652706|NCT01134614|P1|Participant Flow|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
ipilimumab: Given IV
sargramostim: Given SC"
652707|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
ipilimumab: Given IV"
652708|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
ipilimumab: Given IV
sargramostim: Given SC"
652709|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
ipilimumab: Given IV"
652731|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652771|NCT01134731|O1|Outcome|Paliperidone|"dose escalation , levels 1-5 daily dosing ranged from 1-5mg
paliperidone: 1-5 mg qd"
652710|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
ipilimumab: Given IV
sargramostim: Given SC"
652711|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
ipilimumab: Given IV"
652712|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
ipilimumab: Given IV
sargramostim: Given SC"
652713|NCT01134614|E2|Reported Event|Arm B (Ipilimumab)|ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
652714|NCT01134614|E1|Reported Event|Arm A (Ipilimumab and Sargramostim)|ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
652715|NCT01134627|B3|Baseline|Total|Total of all reporting groups
652716|NCT01134627|B2|Baseline|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652717|NCT01134627|B1|Baseline|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652718|NCT01134627|P2|Participant Flow|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652794|NCT01134887|B5|Baseline|Total|Total of all reporting groups
652720|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652721|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652722|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652723|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652724|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652725|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652726|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652727|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652728|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652729|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652730|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652732|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652733|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652734|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652735|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652736|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652737|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652738|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652739|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652740|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652741|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652742|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652743|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652744|NCT01134627|E2|Reported Event|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
652745|NCT01134627|E1|Reported Event|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
652746|NCT01134705|B3|Baseline|Total|Total of all reporting groups
652747|NCT01134705|B2|Baseline|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
652748|NCT01134705|B1|Baseline|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
652749|NCT01134705|P2|Participant Flow|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
652750|NCT01134705|P1|Participant Flow|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily.
652751|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
652752|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
652753|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
652754|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
652755|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
652756|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
652757|NCT01134705|E2|Reported Event|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
652758|NCT01134705|E1|Reported Event|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
652759|NCT01134731|B4|Baseline|Total|Total of all reporting groups
652760|NCT01134731|B3|Baseline|Placebo 1-5 Capsules|12 weeks
652761|NCT01134731|B2|Baseline|Lithium 600-1500mg|daily
652762|NCT01134731|B1|Baseline|Paliperidone 1-5mg|daily
652763|NCT01134731|P3|Participant Flow|Placebo|1-5 capsules
652764|NCT01134731|P2|Participant Flow|Lithium|"mood stabilizer
dose escalation levels 1-5 daily dosing lithium: 300-1500mg daily (QD)"
652765|NCT01134731|P1|Participant Flow|Paliperidone|dose escalation, levels 1-5 daily dosing range from 1-5 mg
652766|NCT01134731|O3|Outcome|Placebo|1-5 placebo capsules
652767|NCT01134731|O2|Outcome|Lithium|"dose escalation, level 1-5 daily dosing 300-1500mg
lithium: 300-1500mg QD"
652768|NCT01134731|O1|Outcome|Paliperidone|"dose escalation , levels 1-5 daily dosing ranged from 1-5mg
paliperidone: 1-5 mg qd"
652769|NCT01134731|O3|Outcome|Placebo|placebo comparator, 1-5 capsules
652770|NCT01134731|O2|Outcome|Lithium|"dose escalation, level 1-5 daily dosing 300-1500mg
lithium: 300-1500mg QD"
652776|NCT01134783|B2|Baseline|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
652777|NCT01134783|B1|Baseline|Control Group|This control group arm consists of students who served as the comparison group.
652778|NCT01134783|P2|Participant Flow|Control Group|217 participants were randomized to the control condition
652779|NCT01134783|P1|Participant Flow|Intervention Group|224 participants were randomized to the intervention condition
652780|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
652781|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website
CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
652782|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
652783|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website
CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
652784|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
652785|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website
CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
652786|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
652787|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website
CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
652788|NCT01134783|O2|Outcome|Control Group|This control group arm consists of students who served as the comparison group.
652789|NCT01134783|O1|Outcome|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
652790|NCT01134783|O2|Outcome|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
652791|NCT01134783|O1|Outcome|Control Group|This control group arm consists of students who served as the comparison group.
652792|NCT01134783|E2|Reported Event|Control Group|This control group consists of students who served as the comparison group.
652793|NCT01134783|E1|Reported Event|Intervention Group|This intervention group is a combination of the face-to-face class students, hybrid class students and online class students.
652795|NCT01134887|B4|Baseline|Arm 4: Control-Physician|"Primary care providers randomly assigned to the Control-Physicians arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual."
652796|NCT01134887|B3|Baseline|Arm 3: Intervention-Physician|"Primary care providers randomly assigned to the Intervention-Physicians arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management."
652797|NCT01134887|B2|Baseline|Arm 2: Control-Veteran|"Veterans enrolled in the Control-Veterans arm received a copy of the NIA guide for Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
652798|NCT01134887|B1|Baseline|Arm 1: Intervention-Veteran|"Veterans enrolled in the Intervention-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
652799|NCT01134887|P4|Participant Flow|Arm 4: Control-Physician|"Primary care providers randomly assigned to the Control-Physicians arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual."
652800|NCT01134887|P3|Participant Flow|Arm 3: Intervention-Physician|"Primary care providers randomly assigned to the Intervention-Physicians arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management."
652801|NCT01134887|P2|Participant Flow|Arm 2: Control-Veteran|"Veterans enrolled in the Control-Veterans arm received a copy of the NIA guide for Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
652829|NCT01134939|P8|Participant Flow|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652830|NCT01134939|P7|Participant Flow|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652831|NCT01134939|P6|Participant Flow|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652802|NCT01134887|P1|Participant Flow|Arm 1: Intervention-Veteran|"Veterans enrolled in the Intervention-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
652803|NCT01134887|O2|Outcome|Arm 2: Control-Veterans|The attention control comparator consisted of giving Veterans a copy of the NIA guide for “Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
652804|NCT01134887|O1|Outcome|Arm 1: Intervention-Veterans|Veterans randomized to the intervention group received a copy of the NIA guide for “Talking with Your Doctor.” Just prior to their next scheduled visit, an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. Additional information was provided on how to be an active participant in the health care encounter and how to communicate effectively to promote productive self-management. To facilitate communication change, the educator assisted the Veteran in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
652805|NCT01134887|E4|Reported Event|Arm 4: Control-Physicians|Control physicians were told to conduct their encounters as usual and were not given any coaching. Adverse event reporting was provided as part of the study.
652806|NCT01134887|E3|Reported Event|Arm 3: Intervention-Physicians|The 5 intervention arm physicians were coached in the Four Habits of Highly Effective Clinicians in a one hour face to face meeting involving review of the provider's interaction with his or her intervention patients and suggestions for improvement based on these observations.
652807|NCT01134887|E2|Reported Event|Arm 2: Attention Control|Veterans enrolled in the attention control arm received a copy of the NIA guide for “Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
652808|NCT01134887|E1|Reported Event|Arm 1: Intervention|Veterans enrolled in the intervention arm received a copy of the NIA guide for “Talking with Your Doctor.” Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. Additional information was provided on how to be an active participant in the health care encounter and how to communicate effectively to promote productive self-management. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
652809|NCT01134900|B3|Baseline|Total|Total of all reporting groups
652810|NCT01134900|B2|Baseline|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
652972|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
652811|NCT01134900|B1|Baseline|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
652812|NCT01134900|P2|Participant Flow|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
652813|NCT01134900|P1|Participant Flow|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
652814|NCT01134900|O2|Outcome|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
652815|NCT01134900|O1|Outcome|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
652816|NCT01134900|O2|Outcome|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
652817|NCT01134900|O1|Outcome|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
652818|NCT01134900|E2|Reported Event|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
652819|NCT01134900|E1|Reported Event|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
652820|NCT01134939|B9|Baseline|Total|Total of all reporting groups
652821|NCT01134939|B8|Baseline|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652822|NCT01134939|B7|Baseline|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652823|NCT01134939|B6|Baseline|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652824|NCT01134939|B5|Baseline|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652825|NCT01134939|B4|Baseline|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652826|NCT01134939|B3|Baseline|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652827|NCT01134939|B2|Baseline|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652828|NCT01134939|B1|Baseline|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652832|NCT01134939|P5|Participant Flow|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652833|NCT01134939|P4|Participant Flow|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652834|NCT01134939|P3|Participant Flow|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652835|NCT01134939|P2|Participant Flow|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652836|NCT01134939|P1|Participant Flow|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652837|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652838|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652839|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652840|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652841|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652842|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652843|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652844|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652845|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652846|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652847|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652848|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652849|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652850|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652851|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652852|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652853|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652854|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652855|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652856|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652857|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652858|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652859|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652860|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652861|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652862|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652863|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652864|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652865|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652866|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652867|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652868|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652869|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652870|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652871|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652872|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652873|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652874|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652875|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652876|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652877|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652878|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652879|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652880|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652881|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652882|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652883|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652884|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652885|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652886|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652887|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652888|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652889|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652890|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652891|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652892|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652893|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652894|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652895|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652896|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652897|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652898|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652899|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652900|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652901|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652902|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652903|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652904|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652905|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652906|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652907|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652908|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652909|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652910|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652911|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652912|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652913|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652914|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652915|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652916|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652917|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652918|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652919|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652920|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652921|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652922|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652923|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652924|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652925|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652926|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652927|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652928|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652929|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652930|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652931|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652932|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652933|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652934|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652935|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652936|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652937|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652938|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652939|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
652940|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
652941|NCT01134939|E4|Reported Event|Patients With Baseline Viral Load Not Documented|Female and male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
652942|NCT01134939|E3|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Female and male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
652943|NCT01134939|E2|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Female and male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
652944|NCT01134939|E1|Reported Event|Treatment-naive Patients|Female and male patients who were not pretreated with HIV therapy.
652945|NCT01134952|B1|Baseline|MMF MRL Switch|Liver transplant recipients with Hepatitis C virus switched from mycophenolate mofetil (MMF) to sirolimus (SRL) for 3 months and then switched back to MMF
652946|NCT01134952|P1|Participant Flow|MMF SRL Switch|Liver transplant recipients with Hepatitis C virus taking sirolimus (SRL) instead of mycophenolate mofetil (MMF) for 3 months
652947|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
652948|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
652949|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
652950|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
652951|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
652952|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
652953|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
652954|NCT01134952|O1|Outcome|MMF SRL Switch|Liver transplant recipients switched from mycophenolate mofetil to sirolimus
652955|NCT01134952|O1|Outcome|MMF SRL Switch|All patients after switch from mycophenolate to sirolimus
652956|NCT01134952|O1|Outcome|MMF SRL Switch|All patients switched for 3 months from mycophenolate mofetil to sirolimus and then back to mycophenolate mofetil
652957|NCT01134952|O1|Outcome|MMF SRL Switch|Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
652958|NCT01134952|E1|Reported Event|MMF SRL Switch|All patients during 3 month period of switch from mycophenolate mofetil (MMF) to sirolimus and for 3 months after switch back to MMF
652959|NCT01135017|B3|Baseline|Total|Total of all reporting groups
652960|NCT01135017|B2|Baseline|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
652961|NCT01135017|B1|Baseline|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
652962|NCT01135017|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
652963|NCT01135017|P1|Participant Flow|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
652964|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
652965|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
652966|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
652967|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
652968|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
652969|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
652970|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
652971|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
652986|NCT01135069|O2|Outcome|Brand|"Treatment of acne for 12 weeks
Percent change (reduction) in acne lesions was 76% reduction"
652987|NCT01135069|O1|Outcome|Generic|"treatment of acne for 12 weeks
Percent change (reduction) in acne lesions was 74% reduction."
652988|NCT01135069|E3|Reported Event|Placebo|Microsphere Gel no active
652989|NCT01135069|E2|Reported Event|Brand|Retin-A Micro 0.1%
652990|NCT01135069|E1|Reported Event|Generic|Tretinoin Microsphere Gel 0.1%
652991|NCT01135134|B3|Baseline|Total|Total of all reporting groups
652992|NCT01135134|B2|Baseline|Placebo|"Placebo MFNS. Administration was as follows:
5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
652993|NCT01135134|B1|Baseline|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
652994|NCT01135134|P2|Participant Flow|Placebo|"Placebo MFNS. Administration was as follows:
5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
652995|NCT01135134|P1|Participant Flow|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
652996|NCT01135134|O2|Outcome|Placebo|"Placebo MFNS. Administration was as follows:
5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
652997|NCT01135134|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
652998|NCT01135134|O2|Outcome|Placebo|"Placebo MFNS. Administration was as follows:
5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
652999|NCT01135134|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
653000|NCT01135134|E2|Reported Event|Placebo|"Placebo MFNS. Administration was as follows:
5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
653001|NCT01135134|E1|Reported Event|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
653002|NCT01135186|B1|Baseline|Open Label Study|"sapropterin dihydrochloride
sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day (week 1 through week 4)
sapropterin dihydrochloride: sapropterin dihydrochloride: 20mg/kg/day (week 5 through week 8)"
653003|NCT01135186|P1|Participant Flow|Open Label Study|"sapropterin dihydrochloride
sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day"
653004|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride
sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day week 1-4, 20mg/kg/day week 5-8."
653005|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride
sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day weeks (1-4) and 20mg/kg/days weeks (week 5-8)"
653006|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride
sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day week 1-4, 20mg/kg/day week 5-8."
653007|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride
sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day"
653008|NCT01135186|E1|Reported Event|Open Label Study|"sapropterin dihydrochloride
sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day (week 1-4) 20 mg/kg/day (week 5-8)"
653009|NCT01135368|B1|Baseline|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
653010|NCT01135368|P1|Participant Flow|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
653011|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653012|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653013|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653014|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653015|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653016|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653017|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653018|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653019|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653020|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653021|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653022|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653023|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653024|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653025|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653026|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653027|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653028|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653029|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653030|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653031|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653032|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653033|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653034|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653035|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653036|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653037|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653038|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653039|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653040|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653041|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653042|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653043|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653044|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653045|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653046|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653047|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653048|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653049|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653050|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
653051|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
653052|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
653053|NCT01135368|O3|Outcome|Pathological|Participants with pathological color vision at Baseline.
653054|NCT01135368|O2|Outcome|Normal|Participants with normal color vision at Baseline.
653055|NCT01135368|O1|Outcome|No Data|Participants with no color vision data at Baseline.
653056|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
653057|NCT01135368|O4|Outcome|Normal|Participants with adaptation classified as normal at Baseline.
653058|NCT01135368|O3|Outcome|Pathological|Participants with adaptation classified as pathological at Baseline.
653059|NCT01135368|O2|Outcome|Decreased Due to Age|Participants with adaptation decreased due to age at Baseline.
653060|NCT01135368|O1|Outcome|Missing Data|Participants with no data at Baseline.
653061|NCT01135368|O4|Outcome|Normal|Participants with adaptation classified as normal at Baseline.
653062|NCT01135368|O3|Outcome|Pathological|Participants with adaptation classified as pathological at Baseline.
653063|NCT01135368|O2|Outcome|Decreased Due to Age|Participants with adaptation decreased due to age at Baseline.
653065|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
653066|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
653067|NCT01135368|O1|Outcome|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.
653068|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
653069|NCT01135368|O5|Outcome|No Data|Participants with no intestinal metaplasia data at Baseline.
653070|NCT01135368|O4|Outcome|Severe|Participants with severe intestinal metaplasia at Baseline.
653071|NCT01135368|O3|Outcome|Moderate|Participants with moderate intestinal metaplasia at Baseline.
653072|NCT01135368|O2|Outcome|Mild|Participants with mild intestinal metaplasia at Baseline.
653073|NCT01135368|O1|Outcome|None|Participants with no intestinal metaplasia at Baseline.
653074|NCT01135368|O5|Outcome|No Data|Participants with no intestinal metaplasia data at Baseline.
653075|NCT01135368|O4|Outcome|Severe|Participants with severe intestinal metaplasia at Baseline.
653076|NCT01135368|O3|Outcome|Moderate|Participants with moderate intestinal metaplasia at Baseline.
653077|NCT01135368|O2|Outcome|Mild|Participants with mild intestinal metaplasia at Baseline.
653078|NCT01135368|O1|Outcome|None|Participants with no intestinal metaplasia at Baseline.
653079|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
653080|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
653081|NCT01135368|O5|Outcome|No Data|Participants with no data at Baseline.
653082|NCT01135368|O4|Outcome|Severe|Participants with severe atrophy at Baseline.
653083|NCT01135368|O3|Outcome|Moderate|Participants with moderate atrophy at Baseline.
653084|NCT01135368|O2|Outcome|Mild|Participants with mild atrophy at Baseline.
653085|NCT01135368|O1|Outcome|No Atrophy|Participants with no atrophy at Baseline.
653086|NCT01135368|O5|Outcome|No Data|Participants with no data at Baseline.
653087|NCT01135368|O4|Outcome|Severe|Participants with severe atrophy at Baseline.
653088|NCT01135368|O3|Outcome|Moderate|Participants with moderate atrophy at Baseline.
653089|NCT01135368|O2|Outcome|Mild|Participants with mild atrophy at Baseline.
653090|NCT01135368|O1|Outcome|No Atrophy|Participants with no atrophy at Baseline.
653091|NCT01135368|O4|Outcome|No Data|Participants with no data at Baseline.
653092|NCT01135368|O3|Outcome|Linear|Participants with linear, chain producing hyperplasia at Baseline.
653093|NCT01135368|O2|Outcome|Simple|Participants with simple (diffuse) hyperplasia at Baseline.
653094|NCT01135368|O1|Outcome|Normal|Participants with normal ECL cell classification at Baseline.
653095|NCT01135368|O5|Outcome|Grade D|Participants with Grade D (mucosal breaks which involve at least 75% of the oesophageal circumference) at Baseline.
653096|NCT01135368|O4|Outcome|Grade C|Participants with Grade C (mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75% of the oesophageal circumference) at Baseline.
653097|NCT01135368|O3|Outcome|Grade B|Participants with Grade B (one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds) at Baseline.
653098|NCT01135368|O2|Outcome|Grade A|Participants with Grade A (one or more mucosal breaks no longer than 5 mm, none of which extends between the tops of the mucosal folds) at Baseline.
653099|NCT01135368|O1|Outcome|Grade 0|Participants with Grade 0 (normal aspect of mucosa) at Baseline.
653100|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
653101|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
653102|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
653103|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
653104|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
653105|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
653106|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
653107|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
653108|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
653109|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
653110|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
653111|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
653112|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
653113|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
653114|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
653115|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
653116|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
653117|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
653118|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
653119|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
653120|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
653121|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
653122|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
653124|NCT01135368|E1|Reported Event|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
653125|NCT01135381|B5|Baseline|Total|Total of all reporting groups
653126|NCT01135381|B4|Baseline|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
653127|NCT01135381|B3|Baseline|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653128|NCT01135381|B2|Baseline|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
653129|NCT01135381|B1|Baseline|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653130|NCT01135381|P4|Participant Flow|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
653131|NCT01135381|P3|Participant Flow|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653132|NCT01135381|P2|Participant Flow|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
653181|NCT01135511|P6|Participant Flow|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653519|NCT01136174|P4|Participant Flow|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653133|NCT01135381|P1|Participant Flow|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653134|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
653135|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653136|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
653137|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653138|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
653139|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653140|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
653141|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653142|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
653172|NCT01135511|B6|Baseline|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653143|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653144|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
653145|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653146|NCT01135381|E4|Reported Event|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
653147|NCT01135381|E3|Reported Event|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653148|NCT01135381|E2|Reported Event|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
653149|NCT01135381|E1|Reported Event|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.
IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
653150|NCT01135420|B3|Baseline|Total|Total of all reporting groups
653163|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"ACycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.
Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
653467|NCT01135524|B1|Baseline|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
653151|NCT01135420|B2|Baseline|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.
Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety"
653152|NCT01135420|B1|Baseline|Usual Care|"Psychiatry inpatient usual care
Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
653153|NCT01135420|P2|Participant Flow|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention incorporated motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.
Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition received an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention had a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition was to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
653154|NCT01135420|P1|Participant Flow|Usual Care|"Psychiatry inpatient usual care
Usual care: All patients in the trial received usual care (i.e., the care they would have received in the absence of a study)."
653155|NCT01135420|O2|Outcome|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.
Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
653156|NCT01135420|O1|Outcome|Usual Care|"Psychiatry inpatient usual care
Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
653500|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
653157|NCT01135420|E2|Reported Event|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.
Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
653158|NCT01135420|E1|Reported Event|Usual Care|"Psychiatry inpatient usual care
Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
653159|NCT01135498|B1|Baseline|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.
Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
653160|NCT01135498|P1|Participant Flow|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2, tablet, orally (PO), every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.
Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
653161|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.
Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
653162|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.
Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
653468|NCT01135524|P1|Participant Flow|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
653164|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.
Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
653165|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.
Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
653166|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.
Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
653167|NCT01135498|E1|Reported Event|Bevacizumab+Eloxatin+Capecitabine/Bevacizumab+Erlotinib|A cycle was defined as the following: participants received 7.5 mg/kg bevacizumab, IV on Day 1; 130 mg/m^2 eloxatin tablets, orally, on Days 1 through 14; and 1000 mg/m^2 capecitabine tablets, orally, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. If all 6 cycles were tolerated with no disease progression, participants then received 7.5 mg/kg bevacizumab, IV on Day 1 and 150 mg erlotinib tablets, orally, once daily. This cycle was repeated every 3 weeks until disease progression.
653168|NCT01135511|B10|Baseline|Total|Total of all reporting groups
653169|NCT01135511|B9|Baseline|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653170|NCT01135511|B8|Baseline|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653171|NCT01135511|B7|Baseline|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653173|NCT01135511|B5|Baseline|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653174|NCT01135511|B4|Baseline|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653175|NCT01135511|B3|Baseline|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653176|NCT01135511|B2|Baseline|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653177|NCT01135511|B1|Baseline|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653178|NCT01135511|P9|Participant Flow|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653179|NCT01135511|P8|Participant Flow|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653180|NCT01135511|P7|Participant Flow|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653469|NCT01135524|O1|Outcome|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
653470|NCT01135524|E1|Reported Event|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
653182|NCT01135511|P5|Participant Flow|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653183|NCT01135511|P4|Participant Flow|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653184|NCT01135511|P3|Participant Flow|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653185|NCT01135511|P2|Participant Flow|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653186|NCT01135511|P1|Participant Flow|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653187|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653188|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653189|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653190|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653191|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653554|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653192|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653193|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653194|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653195|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653196|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653197|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653198|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653199|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653200|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653201|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653202|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653203|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653204|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653205|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653206|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653207|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653208|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653209|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653210|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653555|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653211|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653212|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653213|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653214|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653215|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653216|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653217|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653218|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653219|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653471|NCT01135914|B4|Baseline|Total|Total of all reporting groups
653220|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653221|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653222|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653223|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653224|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653225|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653226|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653227|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653228|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653229|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653230|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653231|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653232|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653233|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653234|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653235|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653236|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653237|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653238|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653623|NCT01136356|O2|Outcome|Buprenorphine|
653239|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653240|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653241|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653242|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653243|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653244|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653245|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653246|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653247|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653248|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653249|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653250|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653251|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653252|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653253|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653254|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653255|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653256|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653257|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653624|NCT01136356|O1|Outcome|Morphine|
653258|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653259|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653260|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653261|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653262|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653263|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653264|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653265|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653266|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653267|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653268|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653269|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653270|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653271|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653272|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653273|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653274|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653275|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653276|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653472|NCT01135914|B3|Baseline|Laser Monotherapy|Participants received Laser photocoagulation therapy only
653277|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653278|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653279|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653280|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653281|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653282|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653283|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653284|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653285|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653286|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653287|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653288|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653289|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653290|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653291|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653292|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653293|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653294|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653295|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653514|NCT01136174|B5|Baseline|Total|Total of all reporting groups
653296|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653297|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653298|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653299|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653300|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653301|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653302|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653303|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653304|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653305|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653306|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653307|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653308|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653309|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653310|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653311|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653312|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653313|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653314|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653625|NCT01136356|O2|Outcome|Buprenorphine|
653315|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653316|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653317|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653318|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653319|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653320|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653321|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653322|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653323|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653324|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653325|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653326|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653327|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653328|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653329|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653330|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653331|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653332|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653333|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653626|NCT01136356|O1|Outcome|Morphine|
653334|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653335|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653336|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653337|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653338|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653339|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653340|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653341|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653342|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653343|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653344|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653345|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653346|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653347|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653348|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653349|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653350|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653351|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653352|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653515|NCT01136174|B4|Baseline|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653353|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653354|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653355|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653356|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653357|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653358|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653359|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653360|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653361|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653362|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653363|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653364|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653365|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653366|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653367|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653368|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653369|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653370|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653371|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653516|NCT01136174|B3|Baseline|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653372|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653373|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653374|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653375|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653376|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653377|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653378|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653379|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653380|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653381|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653382|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653383|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653384|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653385|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653386|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653387|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653388|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653389|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653390|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653391|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653392|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653393|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653394|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653395|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653396|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653397|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653398|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653399|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653400|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653401|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653402|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653403|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653404|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653405|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653406|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653407|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653408|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653409|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653410|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653411|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653412|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653413|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653414|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653415|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653416|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653417|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653418|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653419|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653420|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653421|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653422|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653423|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653424|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653425|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653426|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653427|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653428|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653517|NCT01136174|B2|Baseline|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653429|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653430|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653431|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653432|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653433|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653434|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653435|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653436|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653437|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653438|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653439|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653440|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653441|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653442|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653443|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653444|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653445|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653446|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653447|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653518|NCT01136174|B1|Baseline|Placebo|Placebo oral administration twice a day
653448|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653449|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653450|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653451|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653452|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653453|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653454|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653455|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653456|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653457|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653458|NCT01135511|E9|Reported Event|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653459|NCT01135511|E8|Reported Event|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653460|NCT01135511|E7|Reported Event|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653461|NCT01135511|E6|Reported Event|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653462|NCT01135511|E5|Reported Event|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
653463|NCT01135511|E4|Reported Event|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653464|NCT01135511|E3|Reported Event|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653465|NCT01135511|E2|Reported Event|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653466|NCT01135511|E1|Reported Event|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
653473|NCT01135914|B2|Baseline|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
653474|NCT01135914|B1|Baseline|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
653475|NCT01135914|P3|Participant Flow|Laser Monotherapy|Participants received Laser photocoagulation therapy only
653476|NCT01135914|P2|Participant Flow|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
653477|NCT01135914|P1|Participant Flow|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
653478|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
653479|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
653480|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
653481|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
653482|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
653483|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
653484|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
653485|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
653486|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
653487|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
653488|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
653489|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
653490|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
653491|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
653492|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
653493|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
653494|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
653495|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
653496|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
653497|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
653498|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
653499|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
653501|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
653502|NCT01135914|E3|Reported Event|Laser Monotherapy|Participants received Laser photocoagulation therapy only
653503|NCT01135914|E2|Reported Event|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
653504|NCT01135914|E1|Reported Event|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
653505|NCT01135992|B1|Baseline|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
653506|NCT01135992|P1|Participant Flow|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
653507|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
653508|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
653509|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
653510|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
653511|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
653512|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
653513|NCT01135992|E1|Reported Event|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
653520|NCT01136174|P3|Participant Flow|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653521|NCT01136174|P2|Participant Flow|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653522|NCT01136174|P1|Participant Flow|Placebo|Placebo oral administration twice a day
653523|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
653524|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
653525|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
653526|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
653527|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
653528|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
653529|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
653530|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
653531|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
653532|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
653533|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
653534|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
653535|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
653536|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
653537|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
653538|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
653539|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
653540|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
653541|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
653542|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
653543|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
653544|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
653545|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
653546|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
653547|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
653548|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
653549|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653550|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653551|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653552|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
653553|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653560|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
653561|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653562|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653563|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653564|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
653565|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653566|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653567|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653568|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
653569|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653570|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653571|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653572|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
653573|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653574|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653575|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653576|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
653577|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653578|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653579|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653580|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
653581|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653582|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653583|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653584|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653585|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653586|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653587|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653588|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653589|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653590|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653591|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653592|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653593|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
653594|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
653595|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
653596|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
653597|NCT01136174|E4|Reported Event|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
653598|NCT01136174|E3|Reported Event|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
653599|NCT01136174|E2|Reported Event|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
653600|NCT01136174|E1|Reported Event|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
653601|NCT01136226|B1|Baseline|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
653602|NCT01136226|P1|Participant Flow|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
653603|NCT01136226|O1|Outcome|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
653604|NCT01136226|E1|Reported Event|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
653605|NCT01136291|B3|Baseline|Total|Total of all reporting groups
653606|NCT01136291|B2|Baseline|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
653607|NCT01136291|B1|Baseline|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.
The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.
These women also received nutrition and prenatal care."
653608|NCT01136291|P2|Participant Flow|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
653609|NCT01136291|P1|Participant Flow|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.
The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.
These women also received nutrition and prenatal care."
653610|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
653611|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.
The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.
These women also received nutrition and prenatal care."
653612|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
653717|NCT01136486|B1|Baseline|Level of Severity of TBI|Four categories based on pain severity (no pain, mild, moderate and severe pain).
653613|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.
The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.
These women also received nutrition and prenatal care."
653614|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
653615|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.
The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.
These women also received nutrition and prenatal care."
653616|NCT01136291|E2|Reported Event|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
653617|NCT01136291|E1|Reported Event|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.
The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.
These women also received nutrition and prenatal care."
653618|NCT01136356|B1|Baseline|Within Subjects Design|Participants received both study drugs (buprenorphine and morphine) in a randomized sequence.
653619|NCT01136356|P2|Participant Flow|Buprenorphine First, Then Morphine|Participants randomized to receive buprenorphine (32 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using morphine (120 mg/day i.m.) with the same time course
653620|NCT01136356|P1|Participant Flow|Morphine First, Then Buprenorphine|Participants randomized to receive morphine (120 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using buprenorphine (32 mg/day i.m.) with the same time course
653621|NCT01136356|O2|Outcome|Buprenorphine|
653622|NCT01136356|O1|Outcome|Morphine|
653627|NCT01136356|E1|Reported Event|All Participants|The adverse events were not specified per drug intervention, therefore, the adverse events per interventions is unknown. The data below references the adverse events recorded by licensed nursing personnel during the participants' 59-day protocol in a residential research unit. All participants (N=7) were randomized to receive either buprenorphine (32 mg/day i.m.) or morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day, or 30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received the second opioid administration and spontaneous withdrawal period using the same time course described above.
653628|NCT01136382|B3|Baseline|Total|Total of all reporting groups
653629|NCT01136382|B2|Baseline|Budesonide|Budesonide pMDI 160 mcg bid
653630|NCT01136382|B1|Baseline|Placebo|Placebo pMDI bid
653631|NCT01136382|P2|Participant Flow|Budesonide|Budesonide pMDI 160 mcg bid
653632|NCT01136382|P1|Participant Flow|Placebo|Placebo pMDI bid
653633|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
653634|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
653635|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
653636|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
653637|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
653638|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
653639|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
653640|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
653641|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
653642|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
653643|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
653644|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
653645|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
653646|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
653647|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
653648|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
653649|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
653650|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
653651|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
653652|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
653653|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
653654|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
653655|NCT01136382|E2|Reported Event|Placebo pMDI b.i.d.|
653656|NCT01136382|E1|Reported Event|Budesonide pMDI 160mcg b.i.d.|
653657|NCT01136408|B4|Baseline|Total|Total of all reporting groups
653658|NCT01136408|B3|Baseline|Warfarin|Dose-adjusted warfarin based on target INR values
653659|NCT01136408|B2|Baseline|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653660|NCT01136408|B1|Baseline|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653661|NCT01136408|P3|Participant Flow|Warfarin|Dose-adjusted warfarin based on target INR values
653662|NCT01136408|P2|Participant Flow|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653663|NCT01136408|P1|Participant Flow|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653664|NCT01136408|O3|Outcome|Warfarin|"Dose-adjusted warfarin based on target INR values
Warfarin: Dose-adjusted warfarin based on target INR values"
653870|NCT01129921|O1|Outcome|Mild Group 1 Year-1 Cohort|Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
653665|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|"Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dabigatran etexilate: Dabigatran etexilate 150 mg capsule, twice a day, oral administration"
653666|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|"Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate: Dabigatran etexilate 110 mg capsule, twice a day, oral administration"
653667|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653668|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653669|NCT01136408|O3|Outcome|Warfarin|
653670|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653671|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653672|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653673|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653674|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653675|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653676|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653677|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653678|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653679|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653680|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653681|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653682|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653683|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653684|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653685|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653686|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653687|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653688|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653689|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653690|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653691|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653692|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653693|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653694|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653695|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653696|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653697|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653698|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653699|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653700|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653701|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653702|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653703|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653704|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653705|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653706|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653707|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653708|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653709|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653710|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653711|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
653712|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653713|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653714|NCT01136408|E3|Reported Event|Warfarin|Dose-adjusted warfarin based on target INR values
653715|NCT01136408|E2|Reported Event|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
653716|NCT01136408|E1|Reported Event|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
653915|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
653718|NCT01136486|P1|Participant Flow|Treatment Arm|Pain was assessed with the Visual Analog Scale and patients underwent a brief battery of tests that included assessment of neuropsychological functions, mood, anxiety and community functions.
653719|NCT01136486|O1|Outcome|Severity of Pain by Severity of Injury|
653720|NCT01136486|E1|Reported Event|Severity of Pain by Severity of Injury|
653721|NCT01124292|B4|Baseline|Total|Total of all reporting groups
653722|NCT01124292|B3|Baseline|Subjects With Spinal Cord Injury|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653723|NCT01124292|B2|Baseline|Able-bodied Subject Without Tongue Piercing:|Able-bodied subjects who willing to receive a tongue piercing for this study.
653724|NCT01124292|B1|Baseline|Able-bodied Subject With Tongue Piercing|Able-bodied subjects who already have tongue piercing.
653725|NCT01124292|P3|Participant Flow|Subjects With Spinal Cord Injury|persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653726|NCT01124292|P2|Participant Flow|Able-bodied Subject Without Tongue Piercing|Able-bodied subjects who willing to receive a tongue piercing for this study.
653727|NCT01124292|P1|Participant Flow|Able-bodied Subject With Tongue Piercing|Able-bodied subjects who already have tongue piercing.
653728|NCT01124292|O4|Outcome|Subjects With Spinal Cord Injury (Group-C): Wheelchair Session|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653729|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C): Computer Session|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653730|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653731|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653808|NCT01124422|B2|Baseline|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653732|NCT01124292|O1|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653733|NCT01124292|O1|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653734|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653735|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653736|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653737|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653738|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653739|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653740|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653741|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653742|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653743|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653744|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653745|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653746|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653747|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653748|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653749|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653750|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653751|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653789|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
653752|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653753|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653754|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653755|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653756|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653757|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653758|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653759|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653760|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653761|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653762|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653763|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653764|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653765|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653766|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653767|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653768|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653769|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653770|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653771|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653772|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653773|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653774|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653775|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653776|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653777|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653778|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653779|NCT01124292|E3|Reported Event|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
653780|NCT01124292|E2|Reported Event|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
653781|NCT01124292|E1|Reported Event|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
653782|NCT01124305|B3|Baseline|Total|Total of all reporting groups
653783|NCT01124305|B2|Baseline|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
653784|NCT01124305|B1|Baseline|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
653785|NCT01124305|P2|Participant Flow|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
653786|NCT01124305|P1|Participant Flow|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
653787|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
653788|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
653790|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
653791|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
653792|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
653793|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
653794|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
653795|NCT01124305|E2|Reported Event|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
653796|NCT01124305|E1|Reported Event|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
653797|NCT01124370|B1|Baseline|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
653798|NCT01124370|P1|Participant Flow|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
653799|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
653800|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
653801|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
653802|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
653803|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
653804|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
653805|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
653806|NCT01124370|E1|Reported Event|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
653807|NCT01124422|B3|Baseline|Total|Total of all reporting groups
653809|NCT01124422|B1|Baseline|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
653810|NCT01124422|P3|Participant Flow|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653811|NCT01124422|P2|Participant Flow|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
653812|NCT01124422|P1|Participant Flow|Tiotropium (TIO)|Tiotropium (TIO) was administered in the dose of 18 micrograms (mcg) once daily for a duration of 4 weeks
653813|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653814|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653815|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653816|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653817|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653818|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653819|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653820|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653821|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653822|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653823|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653824|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653825|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653826|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653827|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653828|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653829|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653830|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653831|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653832|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653916|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
653833|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653834|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653835|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653836|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653837|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653838|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653839|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653840|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653841|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653842|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653843|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653844|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653845|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653846|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
653847|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653848|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
653849|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653850|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
653851|NCT01124422|E2|Reported Event|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
653852|NCT01124422|E1|Reported Event|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
653853|NCT01124448|B3|Baseline|Total|Total of all reporting groups
653854|NCT01124448|B2|Baseline|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)
Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
653855|NCT01124448|B1|Baseline|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)
Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
653856|NCT01124448|P2|Participant Flow|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)
Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
653857|NCT01124448|P1|Participant Flow|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)
Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
653858|NCT01124448|O2|Outcome|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)
Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
653859|NCT01124448|O1|Outcome|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)
Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
653860|NCT01124448|E2|Reported Event|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)
Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
653861|NCT01124448|E1|Reported Event|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)
Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
653862|NCT01129921|B3|Baseline|Total|Total of all reporting groups
653863|NCT01129921|B2|Baseline|Sham Procedure|Group 2: sham decompression with trocar placement and no bone or tissue removal
653864|NCT01129921|B1|Baseline|Mild Procedure|Group 1: mild percutaneous decompression with removal of bone and tissue
653865|NCT01129921|P2|Participant Flow|Sham Then Percutaneous Decompression With Mild|Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
653866|NCT01129921|P1|Participant Flow|Percutaneous Decompression Procedure Only|Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
653867|NCT01129921|O2|Outcome|Sham Then Percutaneous Decompression With Mild|Sham Group 2 Year-1 Cohort: After cross-over to the active mild procedure study arm in which bone and tissue were removed using the mild device kit.
653868|NCT01129921|O1|Outcome|Percutaneous Decompression Procedure Only|Mild Group 1 Year-1 Cohort: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
653869|NCT01129921|O2|Outcome|Sham Group 2 Year-1 Cohort After X-over to Mild|Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
653871|NCT01129921|O2|Outcome|Sham Procedure Group 2 Prior to Cross-over|Sham placement of trocar as in percutaneous decompression, with no bone or tissue removal.
653872|NCT01129921|O1|Outcome|Mild Procedure Group 1|Percutaneous decompression with removal of small amounts of bone and tissue to relieve stenosis.
653873|NCT01129921|E2|Reported Event|Sham Procedure With Optional Crossover to Mild Post-unblinding|Sham procedure includes percutaneous trocar placement with no tissue or bone removal.
653874|NCT01129921|E1|Reported Event|Mild Procedure|percutaneous decompression with bone and tissue removal
653875|NCT01129960|B5|Baseline|Total|Total of all reporting groups
653876|NCT01129960|B4|Baseline|Placebo|Placebo: Tablets will be used.
653877|NCT01129960|B3|Baseline|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
653878|NCT01129960|B2|Baseline|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
653879|NCT01129960|B1|Baseline|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
653880|NCT01129960|P4|Participant Flow|Placebo|Placebo: Tablets will be used.
653881|NCT01129960|P3|Participant Flow|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
653882|NCT01129960|P2|Participant Flow|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
653883|NCT01129960|P1|Participant Flow|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
653884|NCT01129960|O4|Outcome|Placebo|Placebo: Tablets will be used.
653885|NCT01129960|O3|Outcome|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
653886|NCT01129960|O2|Outcome|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
653887|NCT01129960|O1|Outcome|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
653888|NCT01129960|E4|Reported Event|Placebo|Placebo: Tablets will be used.
653889|NCT01129960|E3|Reported Event|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
653890|NCT01129960|E2|Reported Event|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
653891|NCT01129960|E1|Reported Event|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
653892|NCT01130051|B1|Baseline|Colcrys® Intact Tab and Colcrys® in Applesauce|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
653893|NCT01130051|P2|Participant Flow|Colcrys® Sprinkled on Applesauce Then Colcrys® Intact Tab|On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours
653894|NCT01130051|P1|Participant Flow|Colcrys® Intact Tab Then Colcrys® Sprinkled on Applesauce|On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours
653895|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
653896|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
653897|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
653898|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
653899|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
653900|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
653901|NCT01130051|E2|Reported Event|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
653902|NCT01130051|E1|Reported Event|Colcrys® 0.6 mg Tablet Administered Intact|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
653903|NCT01130103|B3|Baseline|Total|Total of all reporting groups
653904|NCT01130103|B2|Baseline|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
653905|NCT01130103|B1|Baseline|Paroxetine|Paroxetine and Prolonged Exposure Therapy
653906|NCT01130103|P2|Participant Flow|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
653907|NCT01130103|P1|Participant Flow|Paroxetine|Paroxetine and Prolonged Exposure Therapy
653908|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
653909|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
653910|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
653911|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
653912|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
653913|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
653914|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
653917|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
653918|NCT01130103|E2|Reported Event|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
653919|NCT01130103|E1|Reported Event|Paroxetine|Paroxetine and Prolonged Exposure Therapy
653920|NCT01130168|B1|Baseline|All Participants|
653921|NCT01130168|P6|Participant Flow|Amlodipine/ISMN ER/Placebo (Sequence 6)|Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule for 4 weeks during Period, with a 2-week washout between each period.
653922|NCT01130168|P5|Participant Flow|Placebo/Amlodipine/ISMN ER (Sequence 5)|Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.
653923|NCT01130168|P4|Participant Flow|ISMN ER/Placebo/Amlodipine (Sequence 4)|Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period.
653924|NCT01130168|P3|Participant Flow|Amlodipine/Placebo/ISMN ER (Sequence 3)|Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period
653925|NCT01130168|P2|Participant Flow|ISMN ER/Amlodipine/Placebo (Sequence 2)|Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 3, with a 2-week washout between each period
653926|NCT01130168|P1|Participant Flow|Placebo/ISMN ER/Amlodipine (Sequence 1)|Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period. Experimental: ISMN ER/Amlodipine/Placebo
653927|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
653928|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
653929|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
653930|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
653931|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
653932|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
653933|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
653934|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
653935|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
653936|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
653937|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
653938|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
653939|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
653940|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
653941|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
653942|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
653943|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
653944|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
653945|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
653946|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
653947|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
653948|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
653949|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
653950|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
653951|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
653952|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
653953|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
653954|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
653955|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
653956|NCT01130168|O1|Outcome|ISMN ER|Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.
653957|NCT01130168|E3|Reported Event|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
653958|NCT01130168|E2|Reported Event|ISMN ER|Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.
653959|NCT01130168|E1|Reported Event|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
653983|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
653984|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
653985|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
653960|NCT01130337|B1|Baseline|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
653961|NCT01130337|P1|Participant Flow|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 milligrams per meter squared [mg/m^2] tablet orally [p.o] twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute intravenous [IV] infusion, Day 1 of the cycle)/trastuzumab (8 milligrams per kilograms [mg/kg] on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
653962|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
653963|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
654001|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
654002|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
654003|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
653964|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
653965|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
653966|NCT01130337|E1|Reported Event|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
653967|NCT01130532|B4|Baseline|Total|Total of all reporting groups
653968|NCT01130532|B3|Baseline|Placebo|Placebo for 12 weeks during double-blind treatment period.
653969|NCT01130532|B2|Baseline|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
653970|NCT01130532|B1|Baseline|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
653971|NCT01130532|P4|Participant Flow|5 mg Tadalafil Open-Label Extension|5 mg Tadalafil for 4 weeks during open-label treatment extension period.
653972|NCT01130532|P3|Participant Flow|Placebo|Placebo for 12 weeks during double-blind treatment period.
653973|NCT01130532|P2|Participant Flow|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
653974|NCT01130532|P1|Participant Flow|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
653975|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
653976|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
653977|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
653978|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
653979|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
653980|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
653981|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
653982|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
653986|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
653987|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
653988|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
653989|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
653990|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
653991|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
653992|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
653993|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
653994|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
653995|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
653996|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
653997|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
653998|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
653999|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
654000|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
655511|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
654004|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
654005|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
654006|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
654007|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
654008|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
654009|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
654010|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
654011|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
654012|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
654013|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
654014|NCT01130532|E4|Reported Event|5 mg Tadalafil Open-Label Extension|5 mg Tadalafil for 4 weeks during open-label treatment extension period.
654015|NCT01130532|E3|Reported Event|Placebo|Placebo for 12 weeks during double-blind treatment period.
654016|NCT01130532|E2|Reported Event|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
654017|NCT01130532|E1|Reported Event|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
654018|NCT01130597|B1|Baseline|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654019|NCT01130597|P1|Participant Flow|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654020|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654021|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654022|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654042|NCT01136655|O4|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
654043|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
654023|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654024|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654025|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654026|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654027|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654028|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654029|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654030|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654031|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654032|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654033|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654034|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654035|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654036|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654037|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654038|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654039|NCT01130597|E1|Reported Event|Patiromer|"Spironolactone + Patiromer
Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
654040|NCT01136655|B1|Baseline|Randomized Patients|All randomized patients
654041|NCT01136655|P1|Participant Flow|Randomized Patients|All randomized patients
655329|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
654044|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
654045|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
654046|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
654047|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
654048|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
654049|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
654050|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
654051|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
654052|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
654053|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
654054|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
654055|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
654056|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
654057|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
654058|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
654059|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
654060|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
655512|NCT01142193|O2|Outcome|Placebo|Placebo
654061|NCT01136655|E5|Reported Event|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
654062|NCT01136655|E4|Reported Event|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
654063|NCT01136655|E3|Reported Event|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
654064|NCT01136655|E2|Reported Event|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
654065|NCT01136655|E1|Reported Event|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
654066|NCT01136746|B3|Baseline|Total|Total of all reporting groups
654067|NCT01136746|B2|Baseline|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654068|NCT01136746|B1|Baseline|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654069|NCT01136746|P2|Participant Flow|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654070|NCT01136746|P1|Participant Flow|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654071|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654072|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654073|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654074|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654075|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654076|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654077|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654078|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654079|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654080|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654081|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654082|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654083|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654084|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654085|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654086|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654110|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654087|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654088|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654089|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654090|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654091|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654092|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654093|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654094|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654095|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654096|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654097|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654098|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654099|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654100|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654204|NCT01137604|B4|Baseline|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654101|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654102|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654103|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654104|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654105|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654106|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654107|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654108|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654109|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654924|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654111|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654112|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654113|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654114|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654115|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654116|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654117|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654118|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654119|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654120|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654121|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654122|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654123|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654124|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654125|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654126|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654127|NCT01136746|E2|Reported Event|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
654128|NCT01136746|E1|Reported Event|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
654129|NCT01136772|B3|Baseline|Total|Total of all reporting groups
654130|NCT01136772|B2|Baseline|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
654131|NCT01136772|B1|Baseline|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
654132|NCT01136772|P2|Participant Flow|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
654133|NCT01136772|P1|Participant Flow|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
654134|NCT01136772|O2|Outcome|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
654135|NCT01136772|O1|Outcome|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
654136|NCT01136772|O2|Outcome|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
654137|NCT01136772|O1|Outcome|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
654138|NCT01136772|E2|Reported Event|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
654139|NCT01136772|E1|Reported Event|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
654140|NCT01136785|B3|Baseline|Total|Total of all reporting groups
654141|NCT01136785|B2|Baseline|Sham CPAP|7 days of sham CPAP in the laboratory.
654142|NCT01136785|B1|Baseline|Active CPAP|"7 days of treatment in the laboratory with active CPAP.
Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
654143|NCT01136785|P2|Participant Flow|Sham CPAP|7 days of sham CPAP in the laboratory.
654144|NCT01136785|P1|Participant Flow|Active CPAP|"7 days of treatment in the laboratory with active CPAP.
Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
654145|NCT01136785|O1|Outcome|Active CPAP|The goal of the present analysis is to explore mechanisms by which CPAP therapy led to improvement in the 24-h glucose levels. We focus on the 8 participants who had complete 24-h profiles of plasma norepinephrine before and after treatment with active CPAP.
654146|NCT01136785|O1|Outcome|Active CPAP|The goal of the present analysis is to explore mechanisms by which CPAP therapy led to improvement in the 24-h glucose levels. We focus on the 12 participants who had complete 24-h profiles of glucose, insulin and counter-regulatory hormones before and after treatment with active CPAP.
654147|NCT01136785|O1|Outcome|Active CPAP|The goal of the present analysis is to explore mechanisms by which CPAP therapy led to improvement in the 24-h glucose levels. We focus on the 12 participants who had complete 24-h profiles of glucose, insulin and counter-regulatory hormones before and after treatment with active CPAP.
654148|NCT01136785|O2|Outcome|CPAP|7 days of sham CPAP in the laboratory.
654149|NCT01136785|O1|Outcome|Active CPAP|"7 days of treatment in the laboratory with active CPAP.
Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
654150|NCT01136785|O2|Outcome|Sham CPAP|7 days of sham CPAP in the laboratory.
654151|NCT01136785|O1|Outcome|Active CPAP|"7 days of treatment in the laboratory with active CPAP.
Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
654152|NCT01136785|O2|Outcome|Sham CPAP|7 days of sham CPAP in the laboratory.
654153|NCT01136785|O1|Outcome|Active CPAP|7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea
654154|NCT01136785|E2|Reported Event|Sham CPAP|7 days of sham CPAP in the laboratory.
654155|NCT01136785|E1|Reported Event|Active CPAP|"7 days of treatment in the laboratory with active CPAP.
Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
654156|NCT01137539|B1|Baseline|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
654157|NCT01137539|P1|Participant Flow|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
654158|NCT01137539|O1|Outcome|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
654159|NCT01137539|O1|Outcome|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
654160|NCT01137539|E1|Reported Event|Gynecare TVT-SECUR System|"All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence"
654161|NCT01137578|B1|Baseline|All Imaged Participants|Baseline parameters for all participants in Cohorts A, B, and C: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
654162|NCT01137578|P3|Participant Flow|Sub-Study Cohort C|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
654163|NCT01137578|P2|Participant Flow|Cohort B|Cohort B included pediatric participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT based on radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without gadolinium contrast enhancement) were to be done within 48 hours of each other or, for those with therapeutic anticoagulation, within 24 hours. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT.
654164|NCT01137578|P1|Participant Flow|Cohort A|Cohort A included pediatric participants (full-term newborns to <18 years) in which a CVC was recently placed and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Imaging procedures occurred on Day 40 ± 20 days relative to catheter placement (Day 0) and included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used for MRI with contrast. No sedation or anesthesia was to be allowed. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
654216|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654165|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
654166|NCT01137578|O9|Outcome|Cohort C 12Years to <18Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
654167|NCT01137578|O8|Outcome|Cohort C 2Years to <12Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
654168|NCT01137578|O7|Outcome|Cohort C Newborn to <2Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
654169|NCT01137578|O6|Outcome|Cohort B 12Years to <18Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
654170|NCT01137578|O5|Outcome|Cohort B 2Years to <12Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
654171|NCT01137578|O4|Outcome|Cohort B Newborn to <2Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
654172|NCT01137578|O3|Outcome|Cohort A 12Years to <18Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
654173|NCT01137578|O2|Outcome|Cohort A 2Years to <12Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
654174|NCT01137578|O1|Outcome|Cohort A Newborn to <2Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
654175|NCT01137578|O3|Outcome|Cohort C|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
654217|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654218|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654176|NCT01137578|O2|Outcome|Cohort B|Pediatric Participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
654177|NCT01137578|O1|Outcome|Cohort A|Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia to be allowed. Participants enrolled in Cohort A and who developed symptoms of a venous thromboembolism (VTE), including a symptomatic DVT or a symptomatic pulmonary embolism (PE) prior to their MRI/US, should have been switched to Cohort B.
654178|NCT01137578|O4|Outcome|All Imaged Participants: No MRI With Contrast Performed|Participant had at least one radiographic imaging procedure performed but no study-related MRI with contrast was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
654179|NCT01137578|O3|Outcome|All Imaged Participants: No MRI Without Contrast Performed|Participant had at least one radiographic imaging procedure performed but no study-related MRI without contrast was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
654180|NCT01137578|O2|Outcome|All Imaged Participants: Unilateral Ultrasound Performed|Participant had at least one radiographic imaging procedure performed but a study-related unilateral US instead of a bilateral US was completed. Bilateral US was the protocol-defined procedure but if the participant was not able to complete a bilateral US, then the unilateral US was accepted for evaluation. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
654181|NCT01137578|O1|Outcome|All Imaged Participants: No Ultrasound Performed|Participant had at least one radiographic imaging procedure performed but no study-related US (either bilateral or unilateral) was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
654182|NCT01137578|O6|Outcome|Cohort C Participants 12Years to 18 Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
654183|NCT01137578|O5|Outcome|Cohort C Participants <12Years of Age|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC.
654184|NCT01137578|O4|Outcome|Cohort B Participants 12Years to 18 Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
654185|NCT01137578|O3|Outcome|Cohort B Participants <12Years of Age|Cohort B included pediatric participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without contrast enhancement) were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
654219|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
655513|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
654186|NCT01137578|O2|Outcome|Cohort A Participants 12Years to 18 Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
654187|NCT01137578|O1|Outcome|Cohort A Participants <12Years of Age|Cohort A included pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Diagnostic imaging procedures included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was allowed.
654188|NCT01137578|O3|Outcome|Cohort C|Participants with a CVC in place and having an MRI for clinical reasons were enrolled.
654189|NCT01137578|O2|Outcome|Cohort B|Pediatric Participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
654190|NCT01137578|O1|Outcome|Cohort A|Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia to be allowed. Participants enrolled in Cohort A and who developed symptoms of a venous thromboembolism (VTE), including a symptomatic DVT or a symptomatic pulmonary embolism (PE) prior to their MRI/US, were switched to Cohort B.
654191|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
654192|NCT01137578|O9|Outcome|Cohort C 12Years to <18Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
654829|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
654193|NCT01137578|O8|Outcome|Cohort C 2Years to <12Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
654194|NCT01137578|O7|Outcome|Cohort C Newborn to <2Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
654195|NCT01137578|O6|Outcome|Cohort B 12Years to <18Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
654196|NCT01137578|O5|Outcome|Cohort B 2Years to <12Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
654220|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654221|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654290|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654197|NCT01137578|O4|Outcome|Cohort B Newborn to <2Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
654198|NCT01137578|O3|Outcome|Cohort A 12Years to <18Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
654199|NCT01137578|O2|Outcome|Cohort A 2Years to <12Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
654200|NCT01137578|O1|Outcome|Cohort A Newborn to <2Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
654201|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
654202|NCT01137578|E1|Reported Event|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
654203|NCT01137604|B5|Baseline|Total|Total of all reporting groups
654205|NCT01137604|B3|Baseline|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654206|NCT01137604|B2|Baseline|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654207|NCT01137604|B1|Baseline|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
654208|NCT01137604|P4|Participant Flow|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654209|NCT01137604|P3|Participant Flow|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654210|NCT01137604|P2|Participant Flow|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654211|NCT01137604|P1|Participant Flow|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
654212|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654213|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654214|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654215|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
654289|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654222|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654223|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
654224|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654225|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654226|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654227|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
654228|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654229|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654230|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654231|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
654232|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654233|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654234|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654235|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
654236|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654237|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654238|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
655330|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
654239|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
654240|NCT01137604|E4|Reported Event|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654241|NCT01137604|E3|Reported Event|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654242|NCT01137604|E2|Reported Event|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
654243|NCT01137604|E1|Reported Event|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
654244|NCT01137682|B4|Baseline|Total|Total of all reporting groups
654245|NCT01137682|B3|Baseline|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
654246|NCT01137682|B2|Baseline|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
654247|NCT01137682|B1|Baseline|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
654248|NCT01137682|P3|Participant Flow|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
654249|NCT01137682|P2|Participant Flow|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
654250|NCT01137682|P1|Participant Flow|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
655143|NCT01134016|O1|Outcome|Tmax Day1: 50mg|Patient represent the time to reach the maximum plasma concentration after dose
654251|NCT01137682|O3|Outcome|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
654252|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
654253|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
654254|NCT01137682|O3|Outcome|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
654255|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
654256|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
654257|NCT01137682|E3|Reported Event|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
654258|NCT01137682|E2|Reported Event|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
654259|NCT01137682|E1|Reported Event|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
654260|NCT01137773|B3|Baseline|Total|Total of all reporting groups
654261|NCT01137773|B2|Baseline|Convention Insulin Treatment|conventional (150–170 mg/dl, n = 20) glucose control
654262|NCT01137773|B1|Baseline|Intensive IV Insulin|Patients will received IV insulin to maintain target glucose levels of 80-110 mg/dl
654263|NCT01137773|P2|Participant Flow|Conventional Insulin Treatment|Subjects received conventional (150–170 mg/dl) glucose control
654264|NCT01137773|P1|Participant Flow|Intensive IV Insulin|Patients received target glucose levels of 80-110 mg/dl
654265|NCT01137773|O2|Outcome|Conventional Insulin Treatment|"Patents will receive conventional IV insulin treatment with target glucose levels of 150-170 mg/dl
Conventional insulin treatment: All patients in the trial will have blood taken hourly for glucose analysis , regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level."
654266|NCT01137773|O1|Outcome|Intensive IV Insulin|"Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl
Insulin: All patients in the trial will have blood taken hourly for glucose analysis, regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level."
654267|NCT01137773|O2|Outcome|Convention Insulin Treatment|conventional (150–170 mg/dl, n = 20) glucose control
654268|NCT01137773|O1|Outcome|Intensive IV Insulin|Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl
654269|NCT01137773|E2|Reported Event|Convention Insulin Treatment|target glucose levels of 150-170 mg/dl
654270|NCT01137773|E1|Reported Event|Intensive IV Insulin|Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl
654271|NCT01137786|B3|Baseline|Total|Total of all reporting groups
654272|NCT01137786|B2|Baseline|Iopamidol 370 NGAL Evaluable Population|Non-ionic contrast media comparator: one time administration for PCI
654273|NCT01137786|B1|Baseline|Iodixanol 320 NGAL Evaluable Population|Non-ionic contrast media comparator: one time administration for PCI
654274|NCT01137786|P2|Participant Flow|Iopamidol 370|Non ionic contrast media comparator : one time administration for PCI
654275|NCT01137786|P1|Participant Flow|Iodixanol 320|Non ionic contrast media comparator : one time administration for PCI
654276|NCT01137786|O4|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iopamidol 370.
654277|NCT01137786|O3|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370.
654278|NCT01137786|O2|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320.
654279|NCT01137786|O1|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320.
654280|NCT01137786|E2|Reported Event|Iopamidol 370|Non ionic contrast media comparator : One time administration for PCI
654281|NCT01137786|E1|Reported Event|Iodixanol 320|Non ionic contrast media comparator : one time administration for PCI
654282|NCT01137812|B3|Baseline|Total|Total of all reporting groups
654283|NCT01137812|B2|Baseline|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654284|NCT01137812|B1|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654285|NCT01137812|P2|Participant Flow|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654286|NCT01137812|P1|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654287|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654288|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
655514|NCT01142193|O2|Outcome|Placebo|Placebo
654291|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654292|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654293|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654294|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654295|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654296|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654297|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654298|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654299|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654300|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654301|NCT01137812|E2|Reported Event|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654302|NCT01137812|E1|Reported Event|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
654303|NCT01138007|B4|Baseline|Total|Total of all reporting groups
654304|NCT01138007|B3|Baseline|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
654305|NCT01138007|B2|Baseline|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654306|NCT01138007|B1|Baseline|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654307|NCT01138007|P3|Participant Flow|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
655331|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
654308|NCT01138007|P2|Participant Flow|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654309|NCT01138007|P1|Participant Flow|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654310|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
654311|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654312|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654313|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
654314|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654315|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654316|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
654317|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654318|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654319|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
654320|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654321|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654322|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
654323|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654324|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654325|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
654326|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654327|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654348|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
655332|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
654328|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
654329|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654330|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654331|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
654332|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654333|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654334|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
654335|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654336|NCT01138007|O1|Outcome|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654359|NCT01138098|B1|Baseline|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654337|NCT01138007|E3|Reported Event|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
654338|NCT01138007|E2|Reported Event|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
654339|NCT01138007|E1|Reported Event|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
654340|NCT01138046|B1|Baseline|Lapatinib 1500mg + Paclitaxel 80mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654341|NCT01138046|P1|Participant Flow|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 milligrams (mg) once daily (QD) in combination with intravenous (IV) paclitaxel (80 milligrams per meters squared [mg/m^2]) weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654342|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654343|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654344|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654345|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654346|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654347|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654349|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654350|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654351|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654352|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654353|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654354|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654355|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654356|NCT01138046|E1|Reported Event|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
654357|NCT01138098|B3|Baseline|Total|Total of all reporting groups
654358|NCT01138098|B2|Baseline|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654728|NCT01139047|O2|Outcome|Finacea Gel® 15%|azelaic acid 15 % gel - apply topically to the opposite side of the face twice daily for 3 weeks
655144|NCT01134016|O1|Outcome|Antroquinonol|Maximum Tolerable Dose for Antroquinonol
654360|NCT01138098|P2|Participant Flow|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654361|NCT01138098|P1|Participant Flow|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654362|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654363|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654364|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654365|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654366|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654367|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654368|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654369|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654370|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654371|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654372|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654373|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654374|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654375|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654376|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654377|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654378|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654379|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654380|NCT01138098|E2|Reported Event|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654729|NCT01139047|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
654381|NCT01138098|E1|Reported Event|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
654382|NCT01138111|B1|Baseline|MCI Subjects|Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
654383|NCT01138111|P1|Participant Flow|MCI Subjects|Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection of 300 megaBecqerels (MBq) florbetaben, at baseline, at 12 and 24 months
654384|NCT01138111|O6|Outcome|24 Month 90 Min|24 month PET scan at 90 min post-injection
654385|NCT01138111|O5|Outcome|24 Month 45 Min|24 month PET scan at 45 min post-injection
654386|NCT01138111|O4|Outcome|12 Month 90 Min|12 month PET scan at 90 min post-injection
654387|NCT01138111|O3|Outcome|12 Month 45 Min|12 month PET scan at 45 min post-injection
654388|NCT01138111|O2|Outcome|Baseline 90 Min|Baseline PET scan at 90 min post-injection
654389|NCT01138111|O1|Outcome|Baseline 45 Min|Baseline PET scan at 45 min post-injection
654390|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|24 month PET scan results for subjects who progressed to AD within the two year follow up period
654391|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|24 month scan results for subjects who did not progress to AD through the end of the two year follow up period
654392|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|12 month PET scan results for subjects who progressed to AD within the two year follow up period
654393|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|12 month PET scan results for subjects who did not progress to AD through the end of the two year follow up period
654394|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Baseline PET scan results for subjects who progressed to AD within the two year follow up period
654395|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Baseline PET scan results for subjects who did not progress to AD through the end of the two year follow up period
654396|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|Results from 24 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
654397|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|Results from 24 month scan for participants with no progression to AD within 2 years after baseline scan.
654398|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|Results from 12 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
654399|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|Results from 12 month scan for participants with no progression to AD within 2 years after baseline scan.
654400|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Results from baseline scan for participants with progression from MCI to AD within 2 years after baseline scan.
654401|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Results from baseline scan for participants with no progression to AD within 2 years after baseline scan
654402|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|Mean SUVR for the 24 month PET scan in subjects who progressed to AD during the study
654403|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|Mean SUVR for the 24 month PET scan in subjects who did not progress to AD during the study
654404|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|Mean SUVR for the 12 month PET scan in subjects who progressed to AD during the study
654405|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|Mean SUVR for the 12 month PET scan in subjects who did not progress to AD during the study
654406|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Mean SUVR for the baseline PET scan in subjects who progressed to AD during the study
654407|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Mean SUVR for the baseline PET scan in subjects who did not progress to AD during the study
654408|NCT01138111|E3|Reported Event|MCI Subjects (2nd Repeat Drug Administration)|Subjects with AEs following the third administration of florbetaben (BAY94-9172) at the 24 month visit
654409|NCT01138111|E2|Reported Event|MCI Subjects (1st Repeat Drug Administration)|Subjects with AEs following the second administration of florbetaben (BAY94-9172) at the 12 month visit
654410|NCT01138111|E1|Reported Event|MCI Subjects (Initial Drug Administration)|Subjects with AEs following the initial administration of florbetaben (BAY94-9172) at the baseline visit
654411|NCT01138124|B5|Baseline|Total|Total of all reporting groups
654412|NCT01138124|B4|Baseline|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
654413|NCT01138124|B3|Baseline|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
654414|NCT01138124|B2|Baseline|Pancreatic Cancer Controls|Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
654415|NCT01138124|B1|Baseline|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
654730|NCT01139047|E2|Reported Event|Finacea® Gel 15%|azelaic acid gel 15% - apply topically to the opposite side of the face twice daily for 3 weeks
654416|NCT01138124|P4|Participant Flow|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
654417|NCT01138124|P3|Participant Flow|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
654418|NCT01138124|P2|Participant Flow|Pancreatic Cancer Controls|"Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site.
The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin."
654419|NCT01138124|P1|Participant Flow|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
654420|NCT01138124|O2|Outcome|Controls|Controls
654421|NCT01138124|O1|Outcome|Cases|Cases
654422|NCT01138124|O2|Outcome|Controls|Controls
654423|NCT01138124|O1|Outcome|Cases|Cases
654424|NCT01138124|O2|Outcome|Controls|Controls
654425|NCT01138124|O1|Outcome|Cases|Cases
654426|NCT01138124|O2|Outcome|Controls|Controls
654427|NCT01138124|O1|Outcome|Cases|Cases
654428|NCT01138124|O2|Outcome|Controls|Controls
654429|NCT01138124|O1|Outcome|Cases|Cases
654430|NCT01138124|O2|Outcome|Controls|Controls
654431|NCT01138124|O1|Outcome|Cases|Cases
654432|NCT01138124|O2|Outcome|Controls|Controls
654433|NCT01138124|O1|Outcome|Cases|Cases
654434|NCT01138124|O2|Outcome|Controls|Controls
654435|NCT01138124|O1|Outcome|Cases|Cases
654436|NCT01138124|E4|Reported Event|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
654466|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654467|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654437|NCT01138124|E3|Reported Event|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
654438|NCT01138124|E2|Reported Event|Pancreatic Cancer Controls|Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
654439|NCT01138124|E1|Reported Event|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
654440|NCT01138150|B3|Baseline|Total|Total of all reporting groups
654441|NCT01138150|B2|Baseline|Sugar Pill|Participants randomized to placebo (sugar pill) during acute migraine attack.
654442|NCT01138150|B1|Baseline|Treximet|Participants randomized to active drug Treximet during acute migraine attack.
654443|NCT01138150|P2|Participant Flow|Placebo|Participants randomized to placebo upon presentation with acute migraine attack.
654444|NCT01138150|P1|Participant Flow|Active Drug - Sumatriptan/Naproxen|Participants randomized to sumatriptan/naproxen upon presentation of migraine acute attack
654445|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654446|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654447|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654448|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654449|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654731|NCT01139047|E1|Reported Event|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
654450|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654451|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654452|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654453|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654454|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654455|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654456|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654457|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654458|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654459|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654460|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654461|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654462|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654463|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654464|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654465|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654468|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654469|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654470|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654471|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654472|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654473|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654474|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654475|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654476|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654477|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654478|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654479|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654480|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654481|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654482|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654483|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654484|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654485|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
654486|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
654487|NCT01138150|O6|Outcome|Treatment Non-Responders|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
654488|NCT01138150|O5|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
654489|NCT01138150|O4|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
654490|NCT01138150|O3|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
654491|NCT01138150|O2|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
654492|NCT01138150|O1|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
654493|NCT01138150|E2|Reported Event|Sugar Pill|Placebo: One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
654494|NCT01138150|E1|Reported Event|Treximet|sumatriptan/naproxen sodium: One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
654495|NCT01138475|B4|Baseline|Total|Total of all reporting groups
654496|NCT01138475|B3|Baseline|Placebo|
654497|NCT01138475|B2|Baseline|Cholecalciferol|
654498|NCT01138475|B1|Baseline|Paricalcitol|
654545|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
654546|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
654547|NCT01138514|O3|Outcome|Vehicle|Placebo: Placebo
654499|NCT01138475|P3|Participant Flow|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.
This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
654500|NCT01138475|P2|Participant Flow|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
654501|NCT01138475|P1|Participant Flow|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
654502|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
654503|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.
This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
654661|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.
Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
654504|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
654505|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
654506|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.
This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
654507|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
654508|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
654509|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.
This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
654548|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
654510|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
654511|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
654512|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.
This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
654513|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
654514|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
654515|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.
This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
654516|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
654517|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
654518|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.
This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
654519|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
654520|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
654521|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.
This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
654522|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
654523|NCT01138475|O3|Outcome|Placebo|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).
Placebo: Inactive substance, one capsule daily for 6 weeks"
654524|NCT01138475|O2|Outcome|Cholecalciferol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).
Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks"
654525|NCT01138475|O1|Outcome|Paricalcitol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).
Paricalcitol: 1 microgram by mouth daily for 6 weeks"
654526|NCT01138475|O3|Outcome|Placebo|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Placebo: Inactive substance, one capsule daily for 6 weeks"
654527|NCT01138475|O2|Outcome|Cholecalciferol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks"
654528|NCT01138475|O1|Outcome|Paricalcitol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Paricalcitol: 1 microgram by mouth daily for 6 weeks"
654529|NCT01138475|E3|Reported Event|Placebo|Placebo capsules, one a day 7 days per week
654530|NCT01138475|E2|Reported Event|Cholecalciferol|cholecalciferol 5000 units per day, 7 days per week
654531|NCT01138475|E1|Reported Event|Paricalcitriol|Paricalcitriol 1 mcg per day 7 days per week
654662|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
654732|NCT01139125|B1|Baseline|Cystagon|One black male and two white males started the study
654532|NCT01138501|B1|Baseline|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
654533|NCT01138501|P1|Participant Flow|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
654534|NCT01138501|O1|Outcome|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
654535|NCT01138501|O1|Outcome|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
654536|NCT01138501|E1|Reported Event|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
654537|NCT01138514|B4|Baseline|Total|Total of all reporting groups
654538|NCT01138514|B3|Baseline|Vehicle|Placebo: Placebo
654539|NCT01138514|B2|Baseline|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
654540|NCT01138514|B1|Baseline|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
654541|NCT01138514|P3|Participant Flow|Vehicle|Placebo: Placebo
654542|NCT01138514|P2|Participant Flow|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
654543|NCT01138514|P1|Participant Flow|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
654544|NCT01138514|O3|Outcome|Vehicle|Placebo
654549|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
654550|NCT01138514|O3|Outcome|Vehicle|Placebo: Placebo
654551|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
654552|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
654553|NCT01138514|E3|Reported Event|Vehicle|Placebo: Placebo
654554|NCT01138514|E2|Reported Event|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
654555|NCT01138514|E1|Reported Event|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
654556|NCT01138657|B3|Baseline|Total|Total of all reporting groups
654557|NCT01138657|B2|Baseline|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654558|NCT01138657|B1|Baseline|Placebo|Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654559|NCT01138657|P2|Participant Flow|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654560|NCT01138657|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654561|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
655515|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
654562|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654563|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654564|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654565|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654566|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654567|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654568|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654569|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654570|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654611|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
654612|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
654571|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654572|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654573|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654574|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654575|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654576|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654577|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654578|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654579|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654580|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654581|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654582|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654583|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654584|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654585|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654586|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654587|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654588|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654589|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654590|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654591|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654592|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654593|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654594|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654595|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654596|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654597|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654598|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654599|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654600|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654601|NCT01138657|E2|Reported Event|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654602|NCT01138657|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
654603|NCT01138735|B3|Baseline|Total|Total of all reporting groups
654604|NCT01138735|B2|Baseline|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
654605|NCT01138735|B1|Baseline|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
654606|NCT01138735|P2|Participant Flow|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
654607|NCT01138735|P1|Participant Flow|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
654608|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
654609|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
654610|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
654613|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
654614|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
654615|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
654616|NCT01138735|E2|Reported Event|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
654617|NCT01138735|E1|Reported Event|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
654618|NCT01138826|B1|Baseline|Entire Study Population|All participants randomized to any treatment.(Amlodipine tablet first, amlodipine ODT first, and amlodipine ODT without water first).
654619|NCT01138826|P6|Participant Flow|Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet|Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg ODT in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
654620|NCT01138826|P5|Participant Flow|Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT|Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
654621|NCT01138826|P4|Participant Flow|Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water|Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
654622|NCT01138826|P3|Participant Flow|Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet|Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
654623|NCT01138826|P2|Participant Flow|Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT|Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
654697|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
654624|NCT01138826|P1|Participant Flow|Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water|Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg oral disintegrating tablet (ODT) in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
654625|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654626|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654627|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654628|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654629|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654630|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654631|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654654|NCT01138995|B3|Baseline|Total|Total of all reporting groups
654632|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654633|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654634|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654635|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654636|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654637|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654638|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654639|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654640|NCT01138826|E3|Reported Event|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654641|NCT01138826|E2|Reported Event|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654642|NCT01138826|E1|Reported Event|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
654643|NCT01138969|B3|Baseline|Total|Total of all reporting groups
654644|NCT01138969|B2|Baseline|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
654645|NCT01138969|B1|Baseline|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
654646|NCT01138969|P2|Participant Flow|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
654647|NCT01138969|P1|Participant Flow|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
654648|NCT01138969|O2|Outcome|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
654649|NCT01138969|O1|Outcome|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
654650|NCT01138969|O2|Outcome|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
654651|NCT01138969|O1|Outcome|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
654652|NCT01138969|E2|Reported Event|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
654653|NCT01138969|E1|Reported Event|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
654655|NCT01138995|B2|Baseline|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 42 weeks.
Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.
Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
654656|NCT01138995|B1|Baseline|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.
Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.
Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
654657|NCT01138995|P2|Participant Flow|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 42 weeks.
Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.
Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
654658|NCT01138995|P1|Participant Flow|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.
Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.
Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
654659|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.
The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
654660|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
654698|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
654663|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.
The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
654664|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
654665|NCT01138995|E2|Reported Event|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.
The Ness L300 delivers functional electrical stimulation (FES), is intended to improve gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
654666|NCT01138995|E1|Reported Event|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO) for 30 weeks."
654667|NCT01139008|B1|Baseline|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
654668|NCT01139008|P1|Participant Flow|MetroGel® 1% and Finacea 15%|This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
654669|NCT01139008|O1|Outcome|MetroGel® 1% and Finacea® Gel 15%|This is a split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid 15% gel was applied topically to the opposite side of the face twice daily for 3 weeks
654670|NCT01139008|O2|Outcome|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
654671|NCT01139008|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
654672|NCT01139008|O2|Outcome|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
654673|NCT01139008|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
654674|NCT01139008|E2|Reported Event|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
654675|NCT01139008|E1|Reported Event|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
654676|NCT01139021|B7|Baseline|Total|Total of all reporting groups
654677|NCT01139021|B6|Baseline|B12M13|Subject was randomized in group B13_15_27 but treated as group B12_M13.
654678|NCT01139021|B5|Baseline|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
654679|NCT01139021|B4|Baseline|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
654680|NCT01139021|B3|Baseline|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
654681|NCT01139021|B2|Baseline|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
654682|NCT01139021|B1|Baseline|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
654683|NCT01139021|P6|Participant Flow|B12M13|Subject was randomized in group B13_15_27 but treated as group B12_M13.
654684|NCT01139021|P5|Participant Flow|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
654685|NCT01139021|P4|Participant Flow|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
654686|NCT01139021|P3|Participant Flow|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
654687|NCT01139021|P2|Participant Flow|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
654688|NCT01139021|P1|Participant Flow|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
654689|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
654690|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
654691|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 12 and 14 months of age.
654692|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
654693|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 12 and 14 months of age.
654694|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
654695|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
654696|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
654922|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654699|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
654700|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
654701|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
654702|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
654703|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
654704|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
654705|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
654706|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
654707|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
654708|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
654709|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
654710|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
654711|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
654712|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
654713|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
654827|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
654714|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
654715|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age
654716|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
654717|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
654718|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
654719|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
654720|NCT01139021|E3|Reported Event|B24_26|Subjects assessed for safety and tolerability after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
654721|NCT01139021|E2|Reported Event|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 months of age.
654722|NCT01139021|E1|Reported Event|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
654723|NCT01139047|B1|Baseline|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks
654724|NCT01139047|P1|Participant Flow|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks
654725|NCT01139047|O1|Outcome|MetroGel® 1% and Finacea Gel® 15%|This was a randomized split-face study where metronidazole 1% gel was applied to one side of the face once daily for 3 weeks and azelaic acid 15 % gel was applied to the opposite side of the face twice daily for 3 weeks
654726|NCT01139047|O2|Outcome|Finacea Gel® 15%|azelaic acid 15 % gel - apply topically to the opposite side of the face twice daily for 3 weeks
654727|NCT01139047|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
654733|NCT01139125|P1|Participant Flow|Cystagon (Cysteamine Bitartrate)|Subjects were expected to take cystagon (cysteamine bitarate)14 capsules per day (4 at 7:00 am, 3 at 12:00 pm, 4 at 5:00 pm and 3 at 10:00pm) for 16 weeks.
654734|NCT01139125|O1|Outcome|Cystagon|Subjects are required to take 14 capsules per day for 16 weeks
654735|NCT01139125|E1|Reported Event|Cystagon|Subjects taking 14 capsules per day for 16 weeks
654736|NCT01139164|B4|Baseline|Total|Total of all reporting groups
654737|NCT01139164|B3|Baseline|Group 3: Regimen C|B-Cell Lymphomas
654738|NCT01139164|B2|Baseline|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
654739|NCT01139164|B1|Baseline|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
654740|NCT01139164|P3|Participant Flow|Group 3: Regimen C|B-Cell Lymphomas
654741|NCT01139164|P2|Participant Flow|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
654742|NCT01139164|P1|Participant Flow|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
654743|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
654744|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
654745|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
654746|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
654747|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
654748|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
654749|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
654750|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
654751|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
654752|NCT01139164|E3|Reported Event|Group 3: Regimen C|B-Cell Lymphomas
654753|NCT01139164|E2|Reported Event|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
654754|NCT01139164|E1|Reported Event|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
654755|NCT01139190|B3|Baseline|Total|Total of all reporting groups
654756|NCT01139190|B2|Baseline|Naproxen|Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.
654757|NCT01139190|B1|Baseline|PL3100|Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
654758|NCT01139190|P2|Participant Flow|Naproxen|Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.
654759|NCT01139190|P1|Participant Flow|PL3100|Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
654760|NCT01139190|O2|Outcome|Naproxen|Naproxen: Oral administration
654761|NCT01139190|O1|Outcome|PL3100|PL3100: Oral administration
654762|NCT01139190|E2|Reported Event|Naproxen|Naproxen: Oral administration
654763|NCT01139190|E1|Reported Event|PL3100|PL3100: Oral administration
654764|NCT01139294|B3|Baseline|Total|Total of all reporting groups
654828|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
654765|NCT01139294|B2|Baseline|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours
Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
654766|NCT01139294|B1|Baseline|Standard of Care IV Therapy|control arm of the study
654767|NCT01139294|P2|Participant Flow|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours
Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
654768|NCT01139294|P1|Participant Flow|Standard of Care IV Therapy|control arm of the study
654769|NCT01139294|O2|Outcome|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours
Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
654770|NCT01139294|O1|Outcome|Standard of Care IV Therapy|control arm of the study
654771|NCT01139294|O2|Outcome|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours
Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
654772|NCT01139294|O1|Outcome|Standard of Care IV Therapy|control arm of the study
654773|NCT01139294|E2|Reported Event|Hylenex|"1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours
Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours"
654774|NCT01139294|E1|Reported Event|Standard of Care IV Therapy|control arm of the study
654775|NCT01139411|B3|Baseline|Total|Total of all reporting groups
654776|NCT01139411|B2|Baseline|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement"
654777|NCT01139411|B1|Baseline|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement"
654778|NCT01139411|P2|Participant Flow|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement"
654779|NCT01139411|P1|Participant Flow|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement"
654780|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement"
655516|NCT01142193|E2|Reported Event|Placebo|Placebo
654781|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement"
654782|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement"
654783|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement"
654784|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement"
654785|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement"
654786|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement"
654787|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement"
654788|NCT01139411|O2|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement"
654789|NCT01139411|O1|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement"
654790|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement"
654791|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement"
654792|NCT01139411|O2|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement"
654793|NCT01139411|O1|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement"
654794|NCT01139411|E2|Reported Event|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement"
654795|NCT01139411|E1|Reported Event|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement"
654796|NCT01139450|B4|Baseline|Total|Total of all reporting groups
654797|NCT01139450|B3|Baseline|Vehicle|"Placebo that contains no active pharmaceutical ingredient
Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
654798|NCT01139450|B2|Baseline|Reference|"Reference product that contains the active pharmaceutical ingredient
Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
654799|NCT01139450|B1|Baseline|Test|"Test product that contains the active pharmaceutical ingredient
Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
654800|NCT01139450|P3|Participant Flow|Vehicle|"Placebo that contains no active pharmaceutical ingredient
Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
654801|NCT01139450|P2|Participant Flow|Reference|"Reference product that contains the active pharmaceutical ingredient
Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
654802|NCT01139450|P1|Participant Flow|Test|"Test product that contains the active pharmaceutical ingredient
Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
654803|NCT01139450|O3|Outcome|Vehicle|"Placebo that contains no active pharmaceutical ingredient
Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
654804|NCT01139450|O2|Outcome|Reference|"Reference product that contains the active pharmaceutical ingredient
Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
654805|NCT01139450|O1|Outcome|Test|"Test product that contains the active pharmaceutical ingredient
Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
654806|NCT01139450|E3|Reported Event|Vehicle|"Placebo that contains no active pharmaceutical ingredient
Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
654807|NCT01139450|E2|Reported Event|Reference|"Reference product that contains the active pharmaceutical ingredient
Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
654808|NCT01139450|E1|Reported Event|Test|"Test product that contains the active pharmaceutical ingredient
Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
654809|NCT01139515|B1|Baseline|Entire Study Population|All participants randomized to any treatment (Eletriptan 20 mg tablet first, eletriptan 40 mg tablet first, eletriptan 80 mg tablet first, and eletriptan 40 mg 2 hrs apart repeated dose (80 mg in total).
655517|NCT01142193|E1|Reported Event|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
654810|NCT01139515|P4|Participant Flow|Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg|Two oral doses of 40 mg eletriptan tablet administered 2 hrs apart tablet in first intervention period; followed by single oral dose of eletriptan 20 mg in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and single oral dose of eletriptan 40 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
654811|NCT01139515|P3|Participant Flow|Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg|Single oral dose of eletriptan 80 mg tablet in first intervention period; followed by two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in second intervention period; then single oral dose of eletriptan 40 mg tablet in third intervention period; and single oral dose of eletriptan 20 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
654812|NCT01139515|P2|Participant Flow|Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose|Single oral dose of eletriptan 40 mg tablet in first intervention period; followed by single oral dose of eletriptan 80 mg tablet in second intervention period; then single oral dose of eletriptan 20 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
654813|NCT01139515|P1|Participant Flow|Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose|Single oral dose of eletriptan 20 mg tablet in first intervention period; followed by single oral dose of eletriptan 40 mg tablet in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
654814|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
654815|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
654816|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
654817|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
654818|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
654819|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
654820|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
654821|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
654822|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
654823|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
654824|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
654825|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
654826|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
654830|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
654831|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
654832|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
654833|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
654834|NCT01139515|E4|Reported Event|Eletriptan 40 mg 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
654835|NCT01139515|E3|Reported Event|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
654836|NCT01139515|E2|Reported Event|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
654837|NCT01139515|E1|Reported Event|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
654838|NCT01139580|B3|Baseline|Total|Total of all reporting groups
654839|NCT01139580|B2|Baseline|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654840|NCT01139580|B1|Baseline|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654841|NCT01139580|P2|Participant Flow|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654842|NCT01139580|P1|Participant Flow|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body twice daily (BD) for 8 weeks.
654843|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654844|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654845|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654846|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654847|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654848|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654849|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
656252|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
654850|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654851|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654852|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654853|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654854|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654855|NCT01139580|E2|Reported Event|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654856|NCT01139580|E1|Reported Event|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
654857|NCT01139658|B3|Baseline|Total|Total of all reporting groups
654858|NCT01139658|B2|Baseline|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654859|NCT01139658|B1|Baseline|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654860|NCT01139658|P2|Participant Flow|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654861|NCT01139658|P1|Participant Flow|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654862|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654863|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654864|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654865|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654866|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654867|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654868|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654869|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654870|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654871|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654872|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654873|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654874|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654875|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654876|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654877|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654878|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654879|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654880|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654881|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654882|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654923|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654883|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654884|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654885|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654886|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654887|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654888|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654889|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654890|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654891|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654892|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654893|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654894|NCT01139658|E2|Reported Event|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654895|NCT01139658|E1|Reported Event|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
654896|NCT01139762|B3|Baseline|Total|Total of all reporting groups
654897|NCT01139762|B2|Baseline|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654898|NCT01139762|B1|Baseline|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654899|NCT01139762|P3|Participant Flow|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
654900|NCT01139762|P2|Participant Flow|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
654901|NCT01139762|P1|Participant Flow|Screening-Washout and Placebo Lead-In|4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
654902|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654903|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654904|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654905|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654906|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654907|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654908|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654909|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654910|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654911|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654912|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654913|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654914|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654915|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654916|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654917|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654918|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654919|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654920|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654921|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654925|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654926|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654927|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654928|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654929|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
654930|NCT01139762|E3|Reported Event|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
654931|NCT01139762|E2|Reported Event|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
654932|NCT01139762|E1|Reported Event|Screening-Washout and Placebo Lead-In|4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
654933|NCT01139814|B1|Baseline|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
654934|NCT01139814|P1|Participant Flow|Intent-to-Treat|"Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
Amigo RCS is an accessory for use in the cardiac EP setting to allow the operator to manipulate a steerable cardiac catheter and perform a conventional electrophysiology procedure. The intent of the device is to allow the operator to complete the procedure in a conventional x-ray guided EP lab. Catheter control can be performed while standing (or sitting) some distance from the subject to minimize absorbed radiology dose and minimize operator fatigue from standing for long periods of time with the standard lead aprons/personal protection devices."
654935|NCT01139814|O1|Outcome|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
654936|NCT01139814|O1|Outcome|Intent-to-Treat|A subject was considered Intent-to-treat once the subject was evaluated for the study criteria on the day of procedure, the Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
654937|NCT01139814|E1|Reported Event|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
654938|NCT01139879|B1|Baseline|P400|"All patients will receive the P400 mattress
P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
654939|NCT01139879|P1|Participant Flow|P400|"All patients will receive the P400 mattress
P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
654940|NCT01139879|O1|Outcome|P400 Support Surface|All patients will receive the P400 mattress for a period of 12 weeks
654941|NCT01139879|O1|Outcome|P400|The P400 mattress will be placed for a period of 12 weeks for all enrolled patients
654942|NCT01139879|O1|Outcome|P400 Support Surface|"All patients will receive the P400 mattress
P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
654943|NCT01139879|E1|Reported Event|P400 Support Surface|All patients will receive the P400 mattress for a period of 12 weeks
654944|NCT01133626|B4|Baseline|Total|Total of all reporting groups
655333|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
654945|NCT01133626|B3|Baseline|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
654946|NCT01133626|B2|Baseline|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
654947|NCT01133626|B1|Baseline|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
654948|NCT01133626|P3|Participant Flow|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
654949|NCT01133626|P2|Participant Flow|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
654950|NCT01133626|P1|Participant Flow|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
654951|NCT01133626|O3|Outcome|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
654952|NCT01133626|O2|Outcome|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
654953|NCT01133626|O1|Outcome|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
654954|NCT01133626|E3|Reported Event|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
654955|NCT01133626|E2|Reported Event|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
654956|NCT01133626|E1|Reported Event|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
654957|NCT01133665|B1|Baseline|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654958|NCT01133665|P1|Participant Flow|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654959|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654960|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654961|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654962|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654963|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654964|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654965|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654966|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654967|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654968|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654969|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654970|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654971|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654972|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654973|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654974|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654975|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654976|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654977|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654978|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654979|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654980|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
655178|NCT01140061|P4|Participant Flow|Panel B - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
654981|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654982|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654983|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654984|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654985|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654986|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654987|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654988|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654989|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654990|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654991|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654992|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654993|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654994|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654995|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
655334|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
654996|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654997|NCT01133665|E1|Reported Event|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
654998|NCT01133704|B3|Baseline|Total|Total of all reporting groups
654999|NCT01133704|B2|Baseline|Placebo|"All subjects randomized to receive placebo.
Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
655000|NCT01133704|B1|Baseline|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
655001|NCT01133704|P2|Participant Flow|Placebo|"All subjects randomized to receive placebo.
Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
655002|NCT01133704|P1|Participant Flow|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
655003|NCT01133704|O2|Outcome|Placebo|"All subjects randomized to receive placebo.
Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
655004|NCT01133704|O1|Outcome|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
655005|NCT01133704|O2|Outcome|Placebo|"All subjects randomized to receive placebo.
Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
655006|NCT01133704|O1|Outcome|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
655232|NCT01140477|O2|Outcome|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
Accommodating Lens: Accommodating lens implanted during cataract extraction"
655007|NCT01133704|E2|Reported Event|Placebo|"All subjects randomized to receive placebo.
Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
655008|NCT01133704|E1|Reported Event|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
655009|NCT01133756|B4|Baseline|Total|Total of all reporting groups
655010|NCT01133756|B3|Baseline|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655011|NCT01133756|B2|Baseline|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655012|NCT01133756|B1|Baseline|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655013|NCT01133756|P3|Participant Flow|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655014|NCT01133756|P2|Participant Flow|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655015|NCT01133756|P1|Participant Flow|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (area under the concentration-time curve [AUC] 4) + gemcitabine (1000 mg/m2) intravenous (IV) infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655016|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655017|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655018|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655019|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655115|NCT01134016|O1|Outcome|Tumer Responce at Per-protocol (PP) Population|All patients who completed at least 3 cycles of treatment with proper imaging assessment (RECIST) of tumor size.
655020|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655021|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655022|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655023|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655024|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655025|NCT01133756|E3|Reported Event|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) intravenous (IV) infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655026|NCT01133756|E2|Reported Event|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655027|NCT01133756|E1|Reported Event|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
655028|NCT01133821|B3|Baseline|Total|Total of all reporting groups
655029|NCT01133821|B2|Baseline|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.
IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
Medication Dosing
The research pharmacy will dispense medication in the following unit-dose packs:
Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
655030|NCT01133821|B1|Baseline|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.
IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
Medication Dosing
The research pharmacy will dispense medication in the following unit-dose packs:
Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
655031|NCT01133821|P2|Participant Flow|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.
IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
Medication Dosing
The research pharmacy will dispense medication in the following unit-dose packs:
Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
655032|NCT01133821|P1|Participant Flow|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.
IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
Medication Dosing
The research pharmacy will dispense medication in the following unit-dose packs:
Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
655033|NCT01133821|O2|Outcome|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.
IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
Medication Dosing
The research pharmacy will dispense medication in the following unit-dose packs:
Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
655157|NCT01140048|O1|Outcome|All Enrolled Participants|
655158|NCT01140048|O1|Outcome|All Enrolled Participants|
655034|NCT01133821|O1|Outcome|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.
IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
Medication Dosing
The research pharmacy will dispense medication in the following unit-dose packs:
Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
655035|NCT01133821|E2|Reported Event|IPSRT Plus Quetiapine|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.
IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
Medication Dosing
The research pharmacy will dispense medication in the following unit-dose packs:
Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
655036|NCT01133821|E1|Reported Event|Placebo|"Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.
IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
Medication Dosing
The research pharmacy will dispense medication in the following unit-dose packs:
Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
655037|NCT01133847|B4|Baseline|Total|Total of all reporting groups
655038|NCT01133847|B3|Baseline|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655053|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655039|NCT01133847|B2|Baseline|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655040|NCT01133847|B1|Baseline|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655041|NCT01133847|P3|Participant Flow|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655042|NCT01133847|P2|Participant Flow|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655043|NCT01133847|P1|Participant Flow|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655044|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655073|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655045|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655046|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655047|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655048|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655049|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655050|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655051|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655052|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655054|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655055|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655056|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655057|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655058|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655059|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655060|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655061|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655062|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|"All interventions described in Reading Instruction and ADHD treatment arms:
All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training."
655063|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655064|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655065|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655066|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655081|NCT01133860|P1|Participant Flow|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
655360|NCT01141205|O2|Outcome|Placebo|participants receiving saline
655067|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655068|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655069|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655070|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655071|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655072|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655074|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655075|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655076|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655077|NCT01133847|E3|Reported Event|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
655078|NCT01133847|E2|Reported Event|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
655079|NCT01133847|E1|Reported Event|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
655080|NCT01133860|B1|Baseline|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
655142|NCT01134016|O2|Outcome|Tmax Day 1: 100 mg|Patient represent the time to reach the maximum plasma concentration after dose
655082|NCT01133860|O1|Outcome|Eltrombopag|In patients with more than 100 x10e9 platelets/L at the end of therapy, we evaluated also the in vitro platelet aggregation after stimulation with adenosine diphosphate (5 and 20 mcM), collagen (5 and 20 mg/mL) and ristocetin (3 mg/mL) by the densitometric method of Born in native platelet rich plasma. The extent of platelet aggregation was measured 5 minutes after the addition of stimulating agents and results obtained in patients were compared with the normal ranges in the laboratories where the assay was performed. Results are reported as the number of patients with normal platelet aggregation.
655083|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
655084|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
655085|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
655086|NCT01133860|E1|Reported Event|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
655087|NCT01133977|B6|Baseline|Total|Total of all reporting groups
655088|NCT01133977|B5|Baseline|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655089|NCT01133977|B4|Baseline|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655090|NCT01133977|B3|Baseline|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655091|NCT01133977|B2|Baseline|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655159|NCT01140048|O1|Outcome|All Enrolled Participants|
655092|NCT01133977|B1|Baseline|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655093|NCT01133977|P5|Participant Flow|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655094|NCT01133977|P4|Participant Flow|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655095|NCT01133977|P3|Participant Flow|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655096|NCT01133977|P2|Participant Flow|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655097|NCT01133977|P1|Participant Flow|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655098|NCT01133977|O2|Outcome|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655099|NCT01133977|O1|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655100|NCT01133977|O5|Outcome|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655101|NCT01133977|O4|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655102|NCT01133977|O3|Outcome|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655103|NCT01133977|O2|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655104|NCT01133977|O1|Outcome|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655105|NCT01133977|O3|Outcome|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655106|NCT01133977|O2|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655107|NCT01133977|O1|Outcome|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit.
655108|NCT01133977|E5|Reported Event|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655109|NCT01133977|E4|Reported Event|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655110|NCT01133977|E3|Reported Event|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655111|NCT01133977|E2|Reported Event|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655112|NCT01133977|E1|Reported Event|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
655113|NCT01134016|B1|Baseline|Antroquinonol|"Safety dose finding from 50mg to 600mg
Antroquinonol : Dosage form: 50 mg and 100 mg capsules
Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)
Frequency: take daily for 4 weeks per subject per dosage level"
655114|NCT01134016|P1|Participant Flow|Antroquinonol|"Safety dose finding from 50mg to 600mg
Antroquinonol : Dosage form: 50 mg and 100 mg capsules
Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)
Frequency: take daily for 4 weeks per subject per dosage level"
655160|NCT01140048|E1|Reported Event|All Enrolled Participants|
655116|NCT01134016|O1|Outcome|AUC0-t on Day 28|truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 28
655117|NCT01134016|O1|Outcome|AUC0-t on Day 1|truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 1
655118|NCT01134016|O1|Outcome|Cmax Day 28|the observed maximum plasma concentration after dosing on Day 28
655119|NCT01134016|O1|Outcome|Cmax Day 1|the observed maximum plasma concentration after dosing on Day 1
655120|NCT01134016|O12|Outcome|Half-life Time Day 28: 600mg|The time of plasma concentration drops from maximum to half
655121|NCT01134016|O11|Outcome|Half-life Time Day 28: 450 mg|The time of plasma concentration drops from maximum to half
655122|NCT01134016|O10|Outcome|Half-life Time Day 28: 300 mg|The time of plasma concentration drops from maximum to half
655123|NCT01134016|O9|Outcome|Half-life Time Day 28: 200 mg|The time of plasma concentration drops from maximum to half
655124|NCT01134016|O8|Outcome|Half-life Time Day 28:100 mg|The time of plasma concentration drops from maximum to half
655125|NCT01134016|O7|Outcome|Half-life Time Day 28: 50mg|The time of plasma concentration drops from maximum to half
655126|NCT01134016|O6|Outcome|Half-life Time Day 1: 600 mg|The time of plasma concentration drops from maximum to half
655127|NCT01134016|O5|Outcome|Half-life Time Day 1: 450 mg|The time of plasma concentration drops from maximum to half
655128|NCT01134016|O4|Outcome|Half-life Time Day 1: 300mg|The time of plasma concentration drops from maximum to half
655129|NCT01134016|O3|Outcome|Half-life Time Day 1: 200mg|The time of plasma concentration drops from maximum to half
655130|NCT01134016|O2|Outcome|Half-life Time Day 1: 100 mg|The time of plasma concentration drops from maximum to half
655131|NCT01134016|O1|Outcome|Half-life Time Day 1:50mg|The time of plasma concentration drops from maximum to half
655132|NCT01134016|O12|Outcome|Tmax Day 28: 600mg|Patient represent the time to reach the maximum plasma concentration after dose
655133|NCT01134016|O11|Outcome|Tmax Day 28: 450mg|Patient represent the time to reach the maximum plasma concentration after dose
655134|NCT01134016|O10|Outcome|Tmax Day 28: 300mg|Patient represent the time to reach the maximum plasma concentration after dose
655135|NCT01134016|O9|Outcome|Tmax Day 28: 200 mg|Patient represent the time to reach the maximum plasma concentration after dose
655136|NCT01134016|O8|Outcome|Tmax Day 28: 100mg|Patient represent the time to reach the maximum plasma concentration after dose
655137|NCT01134016|O7|Outcome|Tmax Day 28: 50mg|Patient represent the time to reach the maximum plasma concentration after dose
655138|NCT01134016|O6|Outcome|Tmax Day 1 :600 mg|Patient represent the time to reach the maximum plasma concentration after dose
655139|NCT01134016|O5|Outcome|Tmax Day 1: 450mg|Patient represent the time to reach the maximum plasma concentration after dose
655140|NCT01134016|O4|Outcome|Tmax Day 1: 300mg|Patient represent the time to reach the maximum plasma concentration after dose
655141|NCT01134016|O3|Outcome|Tmax Day 1: 200mg|Patient represent the time to reach the maximum plasma concentration after dose
655145|NCT01134016|E1|Reported Event|Antroquinonol|"Safety dose finding from 50mg to 600mg
Antroquinonol : Dosage form: 50 mg and 100 mg capsules
Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)
Frequency: take daily for 4 weeks per subject per dosage level"
655146|NCT01139996|B3|Baseline|Total|Total of all reporting groups
655147|NCT01139996|B2|Baseline|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet
Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
655148|NCT01139996|B1|Baseline|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours
Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
655149|NCT01139996|P2|Participant Flow|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet
Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
655150|NCT01139996|P1|Participant Flow|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours
Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
655151|NCT01139996|O2|Outcome|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet
Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
655152|NCT01139996|O1|Outcome|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours
Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
655153|NCT01139996|E2|Reported Event|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet
Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
655154|NCT01139996|E1|Reported Event|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours
Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
655155|NCT01140048|B1|Baseline|All Enrolled Participants|
655156|NCT01140048|P1|Participant Flow|All Enrolled Participants|
655162|NCT01140061|B10|Baseline|Panel E and Extension - Placebo|In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
655163|NCT01140061|B9|Baseline|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
655164|NCT01140061|B8|Baseline|Panel D - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
655165|NCT01140061|B7|Baseline|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days
655166|NCT01140061|B6|Baseline|Panel C - Placebo|In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
655167|NCT01140061|B5|Baseline|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
655168|NCT01140061|B4|Baseline|Panel B - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
655169|NCT01140061|B3|Baseline|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
655170|NCT01140061|B2|Baseline|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days
655171|NCT01140061|B1|Baseline|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
655172|NCT01140061|P10|Participant Flow|Panel E and Extension - Placebo|In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
655173|NCT01140061|P9|Participant Flow|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
655174|NCT01140061|P8|Participant Flow|Panel D - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
655175|NCT01140061|P7|Participant Flow|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
655176|NCT01140061|P6|Participant Flow|Panel C - Placebo|In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
655177|NCT01140061|P5|Participant Flow|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
655179|NCT01140061|P3|Participant Flow|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
655180|NCT01140061|P2|Participant Flow|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
655181|NCT01140061|P1|Participant Flow|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
655182|NCT01140061|O6|Outcome|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
655183|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
655184|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
655185|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
655186|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
655187|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
655188|NCT01140061|O6|Outcome|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
655189|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
655190|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
655191|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
655192|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
655193|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
655194|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
655195|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
655196|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
655197|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
655198|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
655199|NCT01140061|O2|Outcome|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
655200|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
655201|NCT01140061|E6|Reported Event|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
655202|NCT01140061|E5|Reported Event|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
655203|NCT01140061|E4|Reported Event|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
655204|NCT01140061|E3|Reported Event|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
655205|NCT01140061|E2|Reported Event|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
655206|NCT01140061|E1|Reported Event|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
655207|NCT01140191|B1|Baseline|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396
WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
655208|NCT01140191|P1|Participant Flow|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396
WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
655209|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396
WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
655210|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396
WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
655211|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396
WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
655212|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396
WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
655213|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396
WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
655214|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396
WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
655215|NCT01140191|E1|Reported Event|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396
WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
655216|NCT01140295|B3|Baseline|Total|Total of all reporting groups
655217|NCT01140295|B2|Baseline|2, Senna|"Senna colonoscopy preparation
polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.
Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
655218|NCT01140295|B1|Baseline|1, Miralax|"Miralax colonoscopy preparation
polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.
Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
655219|NCT01140295|P2|Participant Flow|2, Senna|"Senna colonoscopy preparation
polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure."
655220|NCT01140295|P1|Participant Flow|1, Miralax|"Miralax colonoscopy preparation
Miralax (PEG-P) at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
655221|NCT01140295|O2|Outcome|2, Senna|"Senna colonoscopy preparation
Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure."
655222|NCT01140295|O1|Outcome|1, Miralax|"Miralax colonoscopy preparation
Miralax (PEG-P) at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
655223|NCT01140295|O2|Outcome|2, Senna|"Senna colonoscopy preparation
polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.
Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
655224|NCT01140295|O1|Outcome|1, Miralax|"Miralax colonoscopy preparation
polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.
Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
655225|NCT01140295|E2|Reported Event|2, Senna|"Senna colonoscopy preparation
polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.
Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
655226|NCT01140295|E1|Reported Event|1, Miralax|"Miralax colonoscopy preparation
polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.
Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
655227|NCT01140477|B3|Baseline|Total|Total of all reporting groups
655228|NCT01140477|B2|Baseline|Crystalens IOL|Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
655229|NCT01140477|B1|Baseline|Crystalens Toric IOL|Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
655230|NCT01140477|P2|Participant Flow|Crystalens IOL|Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
655231|NCT01140477|P1|Participant Flow|Crystalens Toric IOL|Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
655233|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
655234|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
655235|NCT01140477|O2|Outcome|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
Accommodating Lens: Accommodating lens implanted during cataract extraction"
655236|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
655237|NCT01140477|E2|Reported Event|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
Accommodating Lens: Accommodating lens implanted during cataract extraction"
655238|NCT01140477|E1|Reported Event|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
655239|NCT01140503|B1|Baseline|Apremilast|All subjects received apremilast 20mg PO BID
655240|NCT01140503|P1|Participant Flow|Apremilast|All subjects received apremilast 20mg PO BID
655241|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
655242|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
655243|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
655244|NCT01140503|E1|Reported Event|Apremilast|All subjects received apremilast 20mg PO BID
655245|NCT01140646|B1|Baseline|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
655246|NCT01140646|P1|Participant Flow|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
655247|NCT01140646|O1|Outcome|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
655248|NCT01140646|E1|Reported Event|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
655249|NCT01140815|B3|Baseline|Total|Total of all reporting groups
655250|NCT01140815|B2|Baseline|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System
Deuce: Smith and Nephew Bicompartmental Knee Replacement"
655251|NCT01140815|B1|Baseline|Total (Control)|"The Smith and Nephew Total Knee System
Total Knee Replacement: Smith and Nephew Total Knee Replacement"
655252|NCT01140815|P2|Participant Flow|Deuce|The Journey Deuce Bicompartmental Knee System
655253|NCT01140815|P1|Participant Flow|Total|The Smith and Nephew Total Knee System
655254|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System
Deuce: Smith and Nephew Bicompartmental Knee Replacement"
655335|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
655255|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System
Total Knee Replacement: Smith and Nephew Total Knee Replacement"
655256|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System
Deuce: Smith and Nephew Bicompartmental Knee Replacement"
655257|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System
Total Knee Replacement: Smith and Nephew Total Knee Replacement"
655258|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System
Deuce: Smith and Nephew Bicompartmental Knee Replacement"
655259|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System
Total Knee Replacement: Smith and Nephew Total Knee Replacement"
655260|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System
Deuce: Smith and Nephew Bicompartmental Knee Replacement"
655261|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System
Total Knee Replacement: Smith and Nephew Total Knee Replacement"
655262|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System
Deuce: Smith and Nephew Bicompartmental Knee Replacement"
655263|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System
Total Knee Replacement: Smith and Nephew Total Knee Replacement"
655264|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
655265|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
655266|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
655267|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
655268|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
655269|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
655270|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
655271|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
655272|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
655273|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
655274|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
655275|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
655276|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
655277|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
655278|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
655279|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
655280|NCT01140815|E2|Reported Event|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System
Deuce: Smith and Nephew Bicompartmental Knee Replacement"
655281|NCT01140815|E1|Reported Event|Total (Control)|"The Smith and Nephew Total Knee System
Total Knee Replacement: Smith and Nephew Total Knee Replacement"
655361|NCT01141205|O1|Outcome|Vaccinee|participants receiving active peptide in CAF01 adjuvants vaccine
655282|NCT01140867|B1|Baseline|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
655283|NCT01140867|P1|Participant Flow|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
655284|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
655285|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
655286|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
655287|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
655288|NCT01140867|E1|Reported Event|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
655289|NCT01140880|B3|Baseline|Total|Total of all reporting groups
655290|NCT01140880|B2|Baseline|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655291|NCT01140880|B1|Baseline|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655292|NCT01140880|P2|Participant Flow|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655293|NCT01140880|P1|Participant Flow|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655294|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655295|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655296|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655297|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655298|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655299|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655300|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655362|NCT01141205|E2|Reported Event|Saline|Saline injection
655363|NCT01141205|E1|Reported Event|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
655301|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655302|NCT01140880|E2|Reported Event|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655303|NCT01140880|E1|Reported Event|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
655304|NCT01140906|B5|Baseline|Total|Total of all reporting groups
655305|NCT01140906|B4|Baseline|Duloxetine 60 mg|encapsulated capsules, daily, orally
655306|NCT01140906|B3|Baseline|Vortioxetine 20 mg|encapsulated tablets, daily, orally
655307|NCT01140906|B2|Baseline|Vortioxetine 15 mg|encapsulated tablets, daily, orally
655308|NCT01140906|B1|Baseline|Placebo|capsules, daily, orally
655309|NCT01140906|P4|Participant Flow|Duloxetine 60 mg|encapsulated capsules, daily, orally
655310|NCT01140906|P3|Participant Flow|Vortioxetine 20 mg|encapsulated tablets, daily, orally
655311|NCT01140906|P2|Participant Flow|Vortioxetine 15 mg|encapsulated tablets, daily, orally
655312|NCT01140906|P1|Participant Flow|Placebo|capsules, daily, orally
655313|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
655314|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
655315|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
655316|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
655317|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
655318|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
655319|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
655320|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
655321|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
655322|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
655323|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
655324|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
655325|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
655326|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
655327|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
655328|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
655336|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
655337|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
655338|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
655339|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
655340|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
655341|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
655342|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
655343|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
655344|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
655345|NCT01140906|E4|Reported Event|Duloxetine 60 mg|
655346|NCT01140906|E3|Reported Event|Vortioxetine 20 mg|
655347|NCT01140906|E2|Reported Event|Vortioxetine 15 mg|
655348|NCT01140906|E1|Reported Event|Placebo|
655349|NCT01141205|B3|Baseline|Total|Total of all reporting groups
655350|NCT01141205|B2|Baseline|Saline|Saline injection
655351|NCT01141205|B1|Baseline|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
655352|NCT01141205|P2|Participant Flow|Saline|Placebo was Sterile saline injection, 1.25 ml i.m. (in m. deltoideus) at each vaccination weeks 0, 2, 4, 8
655353|NCT01141205|P1|Participant Flow|AFO-18|18 peptides representing 15 CD8 and 3 CD4 epitopes on HIV-1 plus 1 CD4 T helper epitope unrelated to HIV in an adjuvant (CAF01). Total 4.5 mg peptide (250 micro gram of each peptide) in CAF01 adjuvant. Total volume of 1.25 ml was injected i.m. (in m. deltoideus) at weeks 0, 2, 4, 8
655354|NCT01141205|O2|Outcome|Placebo|participants receiving saline
655355|NCT01141205|O1|Outcome|Vaccinee|participants receiving active peptide in CAF01 adjuvants vaccine
655356|NCT01141205|O2|Outcome|Saline|Placebo participants receiving sterile saline i.m.
655357|NCT01141205|O1|Outcome|Vaccinee|participants receiving active HIV-1 peptide vaccine in CAF01 adjuvant i.m.
655358|NCT01141205|O2|Outcome|Placebo Saline|Saline injection
655359|NCT01141205|O1|Outcome|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
655364|NCT01141283|B1|Baseline|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
655365|NCT01141283|P1|Participant Flow|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
655366|NCT01141283|O1|Outcome|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
655367|NCT01141283|E1|Reported Event|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
655368|NCT01141374|B4|Baseline|Total|Total of all reporting groups
655369|NCT01141374|B3|Baseline|Control Group|untreated group
655370|NCT01141374|B2|Baseline|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
655371|NCT01141374|B1|Baseline|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
655372|NCT01141374|P3|Participant Flow|Control Group|untreated group
655373|NCT01141374|P2|Participant Flow|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
655374|NCT01141374|P1|Participant Flow|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
655375|NCT01141374|O3|Outcome|Seeds Group|They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation).
655376|NCT01141374|O2|Outcome|Needle Group|Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation).
655377|NCT01141374|O1|Outcome|Control Group|Without intervention
655378|NCT01141374|O3|Outcome|Seeds Group|They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
655379|NCT01141374|O2|Outcome|Needle Group|Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
655380|NCT01141374|O1|Outcome|Control Group|Without intervention
655381|NCT01141374|E3|Reported Event|Control Group|untreated group
655382|NCT01141374|E2|Reported Event|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
655383|NCT01141374|E1|Reported Event|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
655384|NCT01141491|B3|Baseline|Total|Total of all reporting groups
655385|NCT01141491|B2|Baseline|Arm B - OPT-821 Immunologic Adjuvant|OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
655386|NCT01141491|B1|Baseline|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
655387|NCT01141491|P2|Participant Flow|Arm B - OPT-821 Immunologic Adjuvant|Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
655388|NCT01141491|P1|Participant Flow|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
655485|NCT01142128|O1|Outcome|Placebo to Nexium, Alone|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
655389|NCT01141491|O2|Outcome|Arm B - OPT-821 Immunologic Adjuvant|"Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84"
655390|NCT01141491|O1|Outcome|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
655391|NCT01141491|E2|Reported Event|Arm B - OPT-821 Immunologic Adjuvant|OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
655392|NCT01141491|E1|Reported Event|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
655393|NCT01141569|B1|Baseline|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
655394|NCT01141569|P1|Participant Flow|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
655395|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
655396|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
655509|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
655397|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
655398|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
655399|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
655400|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
655401|NCT01141569|E1|Reported Event|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
655402|NCT01141595|B1|Baseline|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
655403|NCT01141595|P1|Participant Flow|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
655404|NCT01141595|O1|Outcome|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
655405|NCT01141595|E1|Reported Event|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
655406|NCT01141647|B1|Baseline|24-Month Supported Employment|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services
Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
655407|NCT01141647|P1|Participant Flow|24-Month Supported Employment|Evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
655408|NCT01141647|O2|Outcome|Participants in SCI-VIP Standard Care|Standard Care group from SCI-VIP trial (NCT00117806): Standard care varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
655409|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
655410|NCT01141647|O2|Outcome|Participants in SCI-VIP Standard Care|Standard Care group from SCI-VIP trial (NCT00117806): Standard care varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
655411|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
655412|NCT01141647|O3|Outcome|Late Stage|Interview data from clinical staff in year 3.
655413|NCT01141647|O2|Outcome|Mid Stage|Interview data from clinical staff from year 2.
655414|NCT01141647|O1|Outcome|Early Stage|Interview data from clinical staff during year 1.
655415|NCT01141647|O1|Outcome|48-Month Supported Employment|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services
Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
655416|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
655417|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
655418|NCT01141647|E1|Reported Event|Baseline Sample (N=1047)|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services
Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
655419|NCT01141660|B3|Baseline|Total|Total of all reporting groups
655420|NCT01141660|B2|Baseline|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
655421|NCT01141660|B1|Baseline|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
655422|NCT01141660|P2|Participant Flow|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
655423|NCT01141660|P1|Participant Flow|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
655424|NCT01141660|O2|Outcome|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
655425|NCT01141660|O1|Outcome|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
655426|NCT01141660|E2|Reported Event|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
655427|NCT01141660|E1|Reported Event|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
655428|NCT01141712|B1|Baseline|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 twice a day (BID) on Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655429|NCT01141712|P1|Participant Flow|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 twice a day from Days -5 to -2, Cytarabine 100 mg/m^2 twice a day from Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655430|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655431|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655432|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655433|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655434|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655435|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655436|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655437|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655438|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655439|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655440|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655441|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655442|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655443|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655444|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655445|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655446|NCT01141712|E1|Reported Event|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
655447|NCT01141725|B1|Baseline|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
bendamustine hydrochloride: Given IV
idarubicin: Given IV"
655448|NCT01141725|P3|Participant Flow|Bendamustine Dose of 75mg/m2/Day|"Patients receive bendamustine hydrochloride 75mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.
Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
655486|NCT01142128|O1|Outcome|Nexium Alone|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
655449|NCT01141725|P2|Participant Flow|Bendamustine Dose of 60mg/m2/Day|"Patients receive bendamustine hydrochloride 60mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.
Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
655450|NCT01141725|P1|Participant Flow|Bendamustine Dose of 45mg/m2/Day|"Patients receive bendamustine hydrochloride 45mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.
Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
655451|NCT01141725|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
bendamustine hydrochloride: Given IV
idarubicin: Given IV"
655452|NCT01141725|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
bendamustine hydrochloride: Given IV
idarubicin: Given IV"
655453|NCT01141725|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
bendamustine hydrochloride: Given IV
idarubicin: Given IV"
655454|NCT01141725|O3|Outcome|Treatment C|"Patients receive bendamustine hydrochloride 75mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.
Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
655455|NCT01141725|O2|Outcome|Treatment B|"Patients receive bendamustine hydrochloride 60mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.
Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
655456|NCT01141725|O1|Outcome|Treatment A|"Patients receive bendamustine hydrochloride 45mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.
Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
655457|NCT01141725|O3|Outcome|Treatment C|"Patients receive bendamustine hydrochloride 75mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.
Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
655458|NCT01141725|O2|Outcome|Treatment B|"Patients receive bendamustine hydrochloride 60mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.
Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
655459|NCT01141725|O1|Outcome|Treatment A|"Patients receive bendamustine hydrochloride 45mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.
Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
655460|NCT01141725|E1|Reported Event|Treatment (Combination Chemotherapy)|"Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
bendamustine hydrochloride: Given IV
idarubicin: Given IV
Adverse event report was not collected by dose level."
655461|NCT01142115|B1|Baseline|Entire Study Population|Includes groups randomized to receive SpeediCath first and Monza first
655462|NCT01142115|P2|Participant Flow|Monza First, Then SpeediCath|Catheterization with Monza catheter on visit 1. Catheterization with SpeediCath catheter on visit 2.
655463|NCT01142115|P1|Participant Flow|SpeediCath First, Then Monza|Catheterization with SpeediCath catheter on visit 1. Catheterization with Monza catheter on visit 2.
655464|NCT01142115|O2|Outcome|SpeediCath|Control Product
655465|NCT01142115|O1|Outcome|Monza|Test product
655466|NCT01142115|O2|Outcome|SpeediCath|Control Product
655467|NCT01142115|O1|Outcome|Monza|Test product
655468|NCT01142115|O2|Outcome|SpeediCath|Control Product
655469|NCT01142115|O1|Outcome|Monza|Test product
655470|NCT01142115|O2|Outcome|SpeediCath|Control Product
655471|NCT01142115|O1|Outcome|Monza|Test product
655472|NCT01142115|O2|Outcome|SpeediCath|Control Product
655473|NCT01142115|O1|Outcome|Monza|Test product
655474|NCT01142115|O2|Outcome|SpeediCath|Control Product
655475|NCT01142115|O1|Outcome|Monza|Test product
655476|NCT01142115|E1|Reported Event|Entire Study Population|Includes groups randomized to receive SpeediCath first and Monza first
655477|NCT01142128|B5|Baseline|Total|Total of all reporting groups
655478|NCT01142128|B4|Baseline|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
655479|NCT01142128|B3|Baseline|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
655480|NCT01142128|B2|Baseline|Placebo to Nexium, Alone|Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
655481|NCT01142128|B1|Baseline|Nexium Alone|Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
655482|NCT01142128|P1|Participant Flow|All Participants|"Participants received one of four interventions in a randomized crossover design:
Nexium Alone: Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
Placebo to Nexium, Alone: Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
Viokase 16 Plus Nexium: Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
Viokase 16 Plus Placebo to Nexium: Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone"
655483|NCT01142128|O1|Outcome|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
655484|NCT01142128|O1|Outcome|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
656345|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
655487|NCT01142128|E4|Reported Event|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
655488|NCT01142128|E3|Reported Event|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
655489|NCT01142128|E2|Reported Event|Placebo to Nexium, Alone|Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
655490|NCT01142128|E1|Reported Event|Nexium Alone|Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
655491|NCT01142193|B3|Baseline|Total|Total of all reporting groups
655492|NCT01142193|B2|Baseline|Placebo|Placebo
655493|NCT01142193|B1|Baseline|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
655494|NCT01142193|P2|Participant Flow|Placebo|Placebo
655495|NCT01142193|P1|Participant Flow|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
655496|NCT01142193|O2|Outcome|Placebo|Placebo
655497|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
655498|NCT01142193|O2|Outcome|Placebo|Placebo
655499|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
655500|NCT01142193|O2|Outcome|Placebo|Placebo
655501|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
655502|NCT01142193|O2|Outcome|Placebo|Placebo
655503|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
655504|NCT01142193|O2|Outcome|Placebo|Placebo
655505|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
655506|NCT01142193|O2|Outcome|Placebo|Placebo
655507|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
655508|NCT01142193|O2|Outcome|Placebo|Placebo
655510|NCT01142193|O2|Outcome|Placebo|Placebo
655518|NCT01142297|B1|Baseline|Dental Implant|"standard SLA surface and chemically modified surface
dental implant : standard SLA surface and modified dental implant : chemically modified surface"
655519|NCT01142297|P1|Participant Flow|Dental Implant|standard SLA surface and chemically-modified surface implant
655520|NCT01142297|O2|Outcome|Modified SLA Minimum ISQ HbA1c<9.5|"chemically modified surface
modified dental implant : chemically modified surface"
655521|NCT01142297|O1|Outcome|SLA Minimum ISQ HbA1c<9.5|"standard SLA surface
dental implant : standard SLA surface"
655522|NCT01142297|E2|Reported Event|Modified Dental Implant|"chemically modified surface
modified dental implant : chemically modified surface"
655523|NCT01142297|E1|Reported Event|Dental Implant|"standard SLA surface
dental implant : standard SLA surface"
655524|NCT01142323|B1|Baseline|Fenofibrate|fenofibrate 160 mg po daily
655525|NCT01142323|P1|Participant Flow|Fenofibrate|fenofibrate 160 mg po daily
655526|NCT01142323|O2|Outcome|At 6 Months|fenofibrate 160 mg/day
655527|NCT01142323|O1|Outcome|Baseline|Prior to drug intervention
655528|NCT01142323|E1|Reported Event|Fenofibrate|fenofibrate 160 mg po daily
655529|NCT01142336|B3|Baseline|Total|Total of all reporting groups
655530|NCT01142336|B2|Baseline|Simvastatin|Simvastatin 40mg qHS for 1 year
655531|NCT01142336|B1|Baseline|Placebo|Placebo 1 tablet qHS for 1 year
655532|NCT01142336|P2|Participant Flow|Placebo|Placebo 1 tablet qHS for 1 year
655533|NCT01142336|P1|Participant Flow|Simvastatin|Simvastatin 40mg qHS for 1 year
655534|NCT01142336|O2|Outcome|Simvastatin|Simvastatin 40mg qHS for 1 year
655535|NCT01142336|O1|Outcome|Placebo|Placebo 1 tablet qHS for 1 year
655536|NCT01142336|O2|Outcome|Simvastatin|40mg qHS for 1 year
655537|NCT01142336|O1|Outcome|Placebo|1 tablet qHS for 1 year
655538|NCT01142336|O2|Outcome|Simvastatin|40mg qHS for 1 year
655539|NCT01142336|O1|Outcome|Placebo|1 tab qHS for 1 year
655540|NCT01142336|E2|Reported Event|Placebo|Placebo 1 tablet qHS for 1 year
655541|NCT01142336|E1|Reported Event|Simvastatin|Simvastatin 40mg qHS for 1 year
655542|NCT01142388|B3|Baseline|Total|Total of all reporting groups
655543|NCT01142388|B2|Baseline|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.
cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight
paclitaxel: Given IV"
655544|NCT01142388|B1|Baseline|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.
paclitaxel: Given IV"
655545|NCT01142388|P2|Participant Flow|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.
cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight
paclitaxel: Given IV"
655546|NCT01142388|P1|Participant Flow|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.
paclitaxel: Given IV"
655547|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.
cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight
paclitaxel: Given IV"
655548|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.
paclitaxel: Given IV"
655549|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.
cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight
paclitaxel: Given IV"
655550|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.
paclitaxel: Given IV"
656346|NCT01145560|O3|Outcome|Placebo|Saline
655551|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.
cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight
paclitaxel: Given IV"
655552|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.
paclitaxel: Given IV"
655553|NCT01142388|E2|Reported Event|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.
cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight
paclitaxel: Given IV"
655554|NCT01142388|E1|Reported Event|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.
paclitaxel: Given IV"
655555|NCT01142466|B3|Baseline|Total|Total of all reporting groups
655556|NCT01142466|B2|Baseline|No Treatment|Participants in this group did not receive any treatment.
655557|NCT01142466|B1|Baseline|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
655558|NCT01142466|P2|Participant Flow|No Treatment|Participants in this group did not receive any treatment.
655559|NCT01142466|P1|Participant Flow|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
655560|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
655561|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
655562|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
655563|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
655564|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
655565|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
655566|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
656253|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
655567|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
655568|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
655569|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
655570|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
655571|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
655572|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
655573|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
655574|NCT01142466|E2|Reported Event|No Treatment|Participants in this group did not receive any treatment.
655575|NCT01142466|E1|Reported Event|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
655576|NCT01142596|B3|Baseline|Total|Total of all reporting groups
655577|NCT01142596|B2|Baseline|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655578|NCT01142596|B1|Baseline|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655579|NCT01142596|P2|Participant Flow|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655580|NCT01142596|P1|Participant Flow|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124 (NCT01098110), and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655581|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655582|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655583|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655635|NCT01142726|B3|Baseline|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655584|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655585|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655586|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655587|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655588|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655589|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655671|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|"Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months
Abatacept placebo: Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months"
655590|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655591|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655592|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655593|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655594|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655595|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655596|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655597|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655598|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655599|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655600|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655601|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655602|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655603|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655604|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655605|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655672|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
Methotrexate placebo: Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months"
655606|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655607|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655608|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655609|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655610|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655611|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655612|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655613|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655614|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655615|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655616|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655617|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655618|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655619|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655620|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655621|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655673|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months"
655622|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655623|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655624|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655625|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655626|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655627|NCT01142596|E2|Reported Event|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655628|NCT01142596|E1|Reported Event|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
655629|NCT01142661|B1|Baseline|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
655630|NCT01142661|P1|Participant Flow|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
655631|NCT01142661|O1|Outcome|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
655632|NCT01142661|O1|Outcome|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
655633|NCT01142661|E1|Reported Event|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
655634|NCT01142726|B4|Baseline|Total|Total of all reporting groups
655636|NCT01142726|B2|Baseline|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
655637|NCT01142726|B1|Baseline|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
655638|NCT01142726|P3|Participant Flow|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655639|NCT01142726|P2|Participant Flow|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655674|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|"Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months
Abatacept placebo: Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months"
655678|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
655640|NCT01142726|P1|Participant Flow|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept subcutaneous (SC) 125 mg/week and MTX.
655641|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655642|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655643|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655644|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655697|NCT01142726|O2|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655645|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655646|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655647|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655675|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
Methotrexate placebo: Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months"
655648|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655649|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655650|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655651|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655652|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655698|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
655653|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655654|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655655|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655676|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months"
655677|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655656|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655657|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655658|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655659|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655660|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655661|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
655662|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655663|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
655664|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
655665|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655666|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
655667|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
655668|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655669|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
655670|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
655703|NCT01142908|B2|Baseline|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655679|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
655680|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655681|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
655682|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
655683|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655684|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
655685|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
655686|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655687|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
655688|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
655689|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655690|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
655691|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
655692|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655693|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
655694|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
655695|NCT01142726|O2|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
655696|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
655699|NCT01142726|E3|Reported Event|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX. Safety data was collected from Day 1 to 56 days post last dose.
655700|NCT01142726|E2|Reported Event|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX. Safety data was collected from Day 1 to 56 days post last dose.
655701|NCT01142726|E1|Reported Event|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC 125 mg/week and MTX. Safety data was collected from Day 1 to 56 days post last dose.
655702|NCT01142908|B3|Baseline|Total|Total of all reporting groups
655704|NCT01142908|B1|Baseline|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655705|NCT01142908|P2|Participant Flow|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655706|NCT01142908|P1|Participant Flow|Pharmacist CVD|The pharmacist cardiovascular (CVD) intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655707|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655708|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655709|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655710|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655711|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655712|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655713|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655714|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655715|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655716|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655717|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655718|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655719|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655720|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655721|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655722|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655723|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655724|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655725|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655726|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655727|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
656347|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
655728|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655729|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655730|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655731|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655732|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655733|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655734|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655735|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655736|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655737|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655738|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655739|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655740|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655741|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655822|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655742|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655743|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655744|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655745|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655746|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655747|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655748|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655749|NCT01142908|E2|Reported Event|Education Control|The education control group - these participants will receive educational material about CVD reduction.
655750|NCT01142908|E1|Reported Event|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
655751|NCT01136876|B3|Baseline|Total|Total of all reporting groups
655752|NCT01136876|B2|Baseline|Iopamidol 370|Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
655753|NCT01136876|B1|Baseline|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
655754|NCT01136876|P2|Participant Flow|Iopamidol 370|Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
655755|NCT01136876|P1|Participant Flow|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
655756|NCT01136876|O4|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
655757|NCT01136876|O3|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370
655758|NCT01136876|O2|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320
655759|NCT01136876|O1|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320
655760|NCT01136876|E2|Reported Event|Iopamidol 370|Iopamidol 370 Non-ionic low osmolar iodinated contrast media: single administration for percutaneous coronary intervention
655761|NCT01136876|E1|Reported Event|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
655762|NCT01136915|B3|Baseline|Total|Total of all reporting groups
655763|NCT01136915|B2|Baseline|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
655764|NCT01136915|B1|Baseline|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
656348|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
656349|NCT01145560|E3|Reported Event|Placebo|Saline
655765|NCT01136915|P2|Participant Flow|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
655766|NCT01136915|P1|Participant Flow|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
655767|NCT01136915|O4|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iodixanol 320
655768|NCT01136915|O3|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320
655769|NCT01136915|O2|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
655770|NCT01136915|O1|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370
655771|NCT01136915|E2|Reported Event|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
655772|NCT01136915|E1|Reported Event|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
655773|NCT01136954|B3|Baseline|Total|Total of all reporting groups
655774|NCT01136954|B2|Baseline|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
655775|NCT01136954|B1|Baseline|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
655793|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655776|NCT01136954|P2|Participant Flow|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
655777|NCT01136954|P1|Participant Flow|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
655778|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
655779|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
655780|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
655781|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
655782|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
655783|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
655784|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
656350|NCT01145560|E2|Reported Event|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
655785|NCT01136954|O1|Outcome|Zonisamide (Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
655786|NCT01136954|E2|Reported Event|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
655787|NCT01136954|E1|Reported Event|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
655788|NCT01136967|B3|Baseline|Total|Total of all reporting groups
655789|NCT01136967|B2|Baseline|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655790|NCT01136967|B1|Baseline|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655791|NCT01136967|P2|Participant Flow|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655792|NCT01136967|P1|Participant Flow|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655794|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655795|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655796|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655797|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655798|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655799|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655800|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655801|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655802|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655803|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655804|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655805|NCT01136967|E2|Reported Event|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655806|NCT01136967|E1|Reported Event|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
655807|NCT01137032|B1|Baseline|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
655808|NCT01137032|P1|Participant Flow|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
655809|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
655810|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
655811|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
655812|NCT01137032|E1|Reported Event|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
655813|NCT01137071|B1|Baseline|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655814|NCT01137071|P1|Participant Flow|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655815|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655816|NCT01137071|O1|Outcome|Pharmacokinetic|All patients enrolled in the study that received at least 9 doses of investigational product were considered to this analysis.
655817|NCT01137071|O1|Outcome|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655818|NCT01137071|O1|Outcome|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655819|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655820|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655821|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655823|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655824|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655825|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655826|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655827|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655828|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655829|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655830|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655831|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655832|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655833|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655834|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655835|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655836|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655837|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655838|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655839|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655840|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655841|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655842|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655843|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655844|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655845|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655846|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655847|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655848|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655849|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655850|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655851|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655852|NCT01137071|O1|Outcome|hu3S193|"Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
Anti-Lewis Y humanized monoclonal antibody designated orphan drug by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation."
655853|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655854|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655855|NCT01137071|O1|Outcome|hu3S193|"Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
Anti-Lewis Y humanized monoclonal antibody designated orphan drug by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation."
655856|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655857|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655858|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655859|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655860|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655861|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks.
655862|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655863|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655864|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655865|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655866|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655867|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655868|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
656064|NCT01144286|O1|Outcome|Placebo|placebo pessary, single dose
655869|NCT01137071|O1|Outcome|hu3S193|hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
655870|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655871|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655872|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655873|NCT01137071|E1|Reported Event|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
655874|NCT01137292|B1|Baseline|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
655875|NCT01137292|P1|Participant Flow|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
655876|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
655877|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
655912|NCT01137474|B1|Baseline|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
655878|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
655879|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
655880|NCT01137292|E1|Reported Event|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.
Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
655881|NCT01137370|B3|Baseline|Total|Total of all reporting groups
655882|NCT01137370|B2|Baseline|People Without TB|
655883|NCT01137370|B1|Baseline|Patients With TB|
655884|NCT01137370|P2|Participant Flow|People Without TB|
655885|NCT01137370|P1|Participant Flow|Patients With TB|
655886|NCT01137370|O2|Outcome|People Without TB|
655887|NCT01137370|O1|Outcome|Patients With TB|
655888|NCT01137370|E2|Reported Event|People Without TB|
655889|NCT01137370|E1|Reported Event|Patients With TB|
655890|NCT01137396|B3|Baseline|Total|Total of all reporting groups
655891|NCT01137396|B2|Baseline|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks
Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
655892|NCT01137396|B1|Baseline|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks
Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
655893|NCT01137396|P2|Participant Flow|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks
Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
655894|NCT01137396|P1|Participant Flow|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks
Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
655895|NCT01137396|O2|Outcome|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks
Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
655896|NCT01137396|O1|Outcome|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks
Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
655897|NCT01137396|O2|Outcome|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks
Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
655898|NCT01137396|O1|Outcome|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks
Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
655899|NCT01137396|E2|Reported Event|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks
Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
655900|NCT01137396|E1|Reported Event|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks
Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
655901|NCT01137435|B1|Baseline|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
655902|NCT01137435|P1|Participant Flow|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
655903|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
655904|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
655905|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
655906|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
655907|NCT01137435|E1|Reported Event|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
655908|NCT01137474|B5|Baseline|Total|Total of all reporting groups
655909|NCT01137474|B4|Baseline|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
655910|NCT01137474|B3|Baseline|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
655911|NCT01137474|B2|Baseline|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
656351|NCT01145560|E1|Reported Event|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
656352|NCT01145625|B3|Baseline|Total|Total of all reporting groups
655913|NCT01137474|P4|Participant Flow|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
655914|NCT01137474|P3|Participant Flow|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
655915|NCT01137474|P2|Participant Flow|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
655916|NCT01137474|P1|Participant Flow|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
655917|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
655918|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
655919|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
655920|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
655921|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
655922|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
655923|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
655924|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
655925|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
655926|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
655927|NCT01137474|O2|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
655928|NCT01137474|O1|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
655929|NCT01137474|E4|Reported Event|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
655930|NCT01137474|E3|Reported Event|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
655931|NCT01137474|E2|Reported Event|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
655932|NCT01137474|E1|Reported Event|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
655933|NCT01143038|B1|Baseline|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
655973|NCT01143051|E2|Reported Event|Treatment T2|"HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation
epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations"
655974|NCT01143051|E1|Reported Event|Treatment T1|"T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation
epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations"
655934|NCT01143038|P1|Participant Flow|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
655935|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
655936|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
655937|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
655938|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
655939|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
655940|NCT01143038|E1|Reported Event|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
655941|NCT01143051|B7|Baseline|Total|Total of all reporting groups
655942|NCT01143051|B6|Baseline|T2, T1, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
655943|NCT01143051|B5|Baseline|T2, C, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
655944|NCT01143051|B4|Baseline|T1, T2, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
655945|NCT01143051|B3|Baseline|T1, C, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
655975|NCT01143077|B4|Baseline|Total|Total of all reporting groups
656411|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
655946|NCT01143051|B2|Baseline|C, T2, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
655947|NCT01143051|B1|Baseline|C, T1, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
655948|NCT01143051|P6|Participant Flow|T2, T1, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
655949|NCT01143051|P5|Participant Flow|T2, C, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
655950|NCT01143051|P4|Participant Flow|T1, T2, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
655951|NCT01143051|P3|Participant Flow|T1, C, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
655952|NCT01143051|P2|Participant Flow|C, T2, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
655953|NCT01143051|P1|Participant Flow|C, T1, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
655954|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
655955|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
655956|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
655957|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
655958|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
655959|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
655960|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
655961|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
655962|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
655963|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
655964|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
655965|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
655966|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
655967|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
655968|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
655969|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
655970|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
655971|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
655972|NCT01143051|E3|Reported Event|Treatment C|"Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.
epinephrine inhalation aerosol : Single dose 220 mcg/inhalation, 10 inhalations"
655976|NCT01143077|B3|Baseline|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
655977|NCT01143077|B2|Baseline|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
655978|NCT01143077|B1|Baseline|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
655979|NCT01143077|P3|Participant Flow|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
655980|NCT01143077|P2|Participant Flow|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
655981|NCT01143077|P1|Participant Flow|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
655982|NCT01143077|O3|Outcome|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.
655983|NCT01143077|O2|Outcome|Lurasidone Open-Label Arm 40/80|Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
655984|NCT01143077|O1|Outcome|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
655985|NCT01143077|O3|Outcome|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.
655986|NCT01143077|O2|Outcome|Lurasidone Open-Label Arm 40/80|Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
655987|NCT01143077|O1|Outcome|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
655988|NCT01143077|E3|Reported Event|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
655989|NCT01143077|E2|Reported Event|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
655990|NCT01143077|E1|Reported Event|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
655991|NCT01143090|B1|Baseline|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
656065|NCT01144286|E4|Reported Event|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
655992|NCT01143090|P1|Participant Flow|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study.
655993|NCT01143090|O1|Outcome|Lurasidone Overall|
655994|NCT01143090|E1|Reported Event|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
655995|NCT01143142|B3|Baseline|Total|Total of all reporting groups
655996|NCT01143142|B2|Baseline|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.
Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
655997|NCT01143142|B1|Baseline|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.
Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
655998|NCT01143142|P2|Participant Flow|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.
Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
655999|NCT01143142|P1|Participant Flow|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.
Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
656000|NCT01143142|O2|Outcome|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.
Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
656001|NCT01143142|O1|Outcome|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.
Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
656002|NCT01143142|O2|Outcome|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.
Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
656003|NCT01143142|O1|Outcome|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.
Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
656004|NCT01143142|E2|Reported Event|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.
Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
656005|NCT01143142|E1|Reported Event|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.
Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
656006|NCT01143207|B1|Baseline|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive"
656007|NCT01143207|P1|Participant Flow|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive"
656008|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive"
656009|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive"
656010|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive"
656011|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive"
656012|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive"
656013|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive"
656014|NCT01143207|E1|Reported Event|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive"
656015|NCT01144182|B3|Baseline|Total|Total of all reporting groups
656016|NCT01144182|B2|Baseline|Comprehensive Quality Improvement Program (QIP)|Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients.
656017|NCT01144182|B1|Baseline|Current Best Practice (CBP)|Current best practice (CBP) receives the current treatment for patients discharged with heart failure
656018|NCT01144182|P2|Participant Flow|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656019|NCT01144182|P1|Participant Flow|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656020|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656021|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656022|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656023|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656024|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656025|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656026|NCT01144182|O2|Outcome|Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656027|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656028|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656029|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656030|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656031|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656032|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656033|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656034|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656035|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656036|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656037|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656038|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656039|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656040|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656041|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656042|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656043|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656130|NCT01144416|B2|Baseline|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
656412|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656044|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)
Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656045|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656046|NCT01144182|E2|Reported Event|Quality Improvement Program (QIP)|"Quality improvement program (QIP)
The comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
656047|NCT01144182|E1|Reported Event|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
656048|NCT01144286|B5|Baseline|Total|Total of all reporting groups
656049|NCT01144286|B4|Baseline|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
656050|NCT01144286|B3|Baseline|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
656051|NCT01144286|B2|Baseline|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
656052|NCT01144286|B1|Baseline|Placebo|placebo pessary, single dose
656053|NCT01144286|P4|Participant Flow|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
656054|NCT01144286|P3|Participant Flow|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
656055|NCT01144286|P2|Participant Flow|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
656056|NCT01144286|P1|Participant Flow|Placebo|placebo pessary, single dose
656057|NCT01144286|O4|Outcome|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
656058|NCT01144286|O3|Outcome|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
656059|NCT01144286|O2|Outcome|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
656060|NCT01144286|O1|Outcome|Placebo|placebo pessary, single dose
656061|NCT01144286|O4|Outcome|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
656062|NCT01144286|O3|Outcome|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
656063|NCT01144286|O2|Outcome|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
656066|NCT01144286|E3|Reported Event|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
656067|NCT01144286|E2|Reported Event|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
656068|NCT01144286|E1|Reported Event|Placebo|placebo pessary, single dose
656069|NCT01144299|B3|Baseline|Total|Total of all reporting groups
656070|NCT01144299|B2|Baseline|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656071|NCT01144299|B1|Baseline|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656072|NCT01144299|P2|Participant Flow|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656073|NCT01144299|P1|Participant Flow|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656074|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656075|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656076|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656077|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656078|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656079|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656080|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656081|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656082|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656083|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656084|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656085|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656086|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656087|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656088|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656089|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656090|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656091|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656092|NCT01144299|E2|Reported Event|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
656093|NCT01144299|E1|Reported Event|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
656094|NCT01144364|B3|Baseline|Total|Total of all reporting groups
656131|NCT01144416|B1|Baseline|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
656095|NCT01144364|B2|Baseline|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
656096|NCT01144364|B1|Baseline|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656097|NCT01144364|P3|Participant Flow|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
656098|NCT01144364|P2|Participant Flow|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656151|NCT01144442|O1|Outcome|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
656152|NCT01144442|E1|Reported Event|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
656099|NCT01144364|P1|Participant Flow|Induction Phase-Immunochemotherapy Rituximab-FND (R-FND)|Cycles 1 to 4: Participants received rituximab: 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1*, fludarabine (F): 25 mg/m^2 IV on Days 2-4*, mitoxantrone (N): 10 mg/m^2 IV on Day 2*, dexamethasone (D) 10 mg IV (total dose) on Days 2-4*. Cycles were repeated every 28 days for a total of 4 cycles. *In Cycle 1, rituximab was given on Day 8 in order to avoid tumour lysis syndrome. Consequently, in Cycle 1, fludarabine and dexamethasone were given on Days 1, 2, and 3. Mitoxantrone was given on Day 1.
656100|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
656101|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656102|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
656132|NCT01144416|P2|Participant Flow|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
656133|NCT01144416|P1|Participant Flow|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
656413|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656103|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656104|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no treatment (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656105|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
656106|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656107|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
656108|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656109|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656110|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
656134|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
656135|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
656111|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656112|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
656113|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656114|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
656115|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656153|NCT01144598|B1|Baseline|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656219|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
656116|NCT01144364|O1|Outcome|Rituximab Induction|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no therapy (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656117|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
656118|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656119|NCT01144364|E3|Reported Event|Rituximab Induction, Observation Maintenance (Follow-up Phase)|Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
656120|NCT01144364|E2|Reported Event|Rituximab Induction, Rituximab Maintenance (Follow-up Phase)|Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
656121|NCT01144364|E1|Reported Event|Rituximab Induction (Induction Phase Only)|Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).
656122|NCT01144403|B1|Baseline|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
Cyclophosphamide: as prescribed, 6 cycles
Fludarabine: as prescribed, 6 cycles
Mitoxantrone: as prescribed, 6 cycles
Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
656123|NCT01144403|P1|Participant Flow|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
Cyclophosphamide: as prescribed, 6 cycles
Fludarabine: as prescribed, 6 cycles
Mitoxantrone: as prescribed, 6 cycles
Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
656124|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
Cyclophosphamide: as prescribed, 6 cycles
Fludarabine: as prescribed, 6 cycles
Mitoxantrone: as prescribed, 6 cycles
Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
656154|NCT01144598|P1|Participant Flow|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656220|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
656125|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
Cyclophosphamide: as prescribed, 6 cycles
Fludarabine: as prescribed, 6 cycles
Mitoxantrone: as prescribed, 6 cycles
Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
656126|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
Cyclophosphamide: as prescribed, 6 cycles
Fludarabine: as prescribed, 6 cycles
Mitoxantrone: as prescribed, 6 cycles
Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
656127|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy for mantle cell lymphoma. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
cyclophosphamide: as prescribed, 6 cycles
fludarabine: as prescribed, 6 cycles
mitoxantrone: as prescribed, 6 cycles
rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, day 1 of each 28-day cycle, up to 8 cycles"
656128|NCT01144403|E1|Reported Event|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
Cyclophosphamide: as prescribed, 6 cycles
Fludarabine: as prescribed, 6 cycles
Mitoxantrone: as prescribed, 6 cycles
Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
656129|NCT01144416|B3|Baseline|Total|Total of all reporting groups
656314|NCT01145508|B3|Baseline|Total|Total of all reporting groups
656136|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
656137|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
656138|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
656139|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
656140|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
656141|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
656142|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
656143|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
656144|NCT01144416|E4|Reported Event|Daily 300 IU recFSH -Follow-up|Participants who received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
656145|NCT01144416|E3|Reported Event|Single Injection of 150 µg SCH 900962/MK-8962-Follow-up|Participants who received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
656146|NCT01144416|E2|Reported Event|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
656147|NCT01144416|E1|Reported Event|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
656148|NCT01144442|B1|Baseline|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
656149|NCT01144442|P1|Participant Flow|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
656150|NCT01144442|O1|Outcome|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
656155|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656156|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656157|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656158|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656159|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656160|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656161|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656162|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656163|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656164|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656165|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656166|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656167|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656168|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656353|NCT01145625|B2|Baseline|5% MTF|"5% Minoxidil Topical Foam
5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
656169|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656170|NCT01144598|E1|Reported Event|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
656171|NCT01144624|B4|Baseline|Total|Total of all reporting groups
656172|NCT01144624|B3|Baseline|Placebo|Saline
656173|NCT01144624|B2|Baseline|Dose Cohort 2|AZD9773 500/100 units/kg IV
656174|NCT01144624|B1|Baseline|Dose Cohort 1|AZD9773 250/50 units/kg IV
656175|NCT01144624|P3|Participant Flow|Placebo|Saline
656176|NCT01144624|P2|Participant Flow|Dose Cohort 2|AZD9773 500/100 units/kg IV
656177|NCT01144624|P1|Participant Flow|Dose Cohort 1|AZD9773 250/50 units/kg IV
656178|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
656179|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
656180|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
656181|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
656182|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
656183|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
656184|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
656185|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
656186|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
656187|NCT01144624|E3|Reported Event|Placebo|Saline
656188|NCT01144624|E2|Reported Event|Dose Cohort 2|AZD9773 500/100 units/kg IV
656189|NCT01144624|E1|Reported Event|Dose Cohort 1|AZD9773 250/50 units/kg IV
656190|NCT01144715|B3|Baseline|Total|Total of all reporting groups
656191|NCT01144715|B2|Baseline|Control|"Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
656192|NCT01144715|B1|Baseline|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
656193|NCT01144715|P2|Participant Flow|Control|"Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
656194|NCT01144715|P1|Participant Flow|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
656195|NCT01144715|O2|Outcome|Control|"Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
656196|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
656197|NCT01144715|O2|Outcome|Control|"Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
656198|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
656199|NCT01144715|O2|Outcome|Control|"Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
656200|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
656201|NCT01144715|O2|Outcome|Control|"Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
656409|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656202|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
656203|NCT01144715|E2|Reported Event|Control|"Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
656204|NCT01144715|E1|Reported Event|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
656205|NCT01144949|B3|Baseline|Total|Total of all reporting groups
656206|NCT01144949|B2|Baseline|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
656207|NCT01144949|B1|Baseline|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
656208|NCT01144949|P2|Participant Flow|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
656209|NCT01144949|P1|Participant Flow|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
656210|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
656211|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
656212|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
656213|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
656214|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
656215|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
656216|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
656217|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
656218|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
656221|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
656222|NCT01144949|E2|Reported Event|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
656223|NCT01144949|E1|Reported Event|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
656224|NCT01145001|B5|Baseline|Total|Total of all reporting groups
656225|NCT01145001|B4|Baseline|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects"
656226|NCT01145001|B3|Baseline|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis"
656227|NCT01145001|B2|Baseline|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
656228|NCT01145001|B1|Baseline|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
656229|NCT01145001|P4|Participant Flow|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects"
656230|NCT01145001|P3|Participant Flow|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis"
656231|NCT01145001|P2|Participant Flow|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
656232|NCT01145001|P1|Participant Flow|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
656233|NCT01145001|O4|Outcome|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects"
656234|NCT01145001|O3|Outcome|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis"
656235|NCT01145001|O2|Outcome|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
656236|NCT01145001|O1|Outcome|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
656237|NCT01145001|O4|Outcome|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects"
656238|NCT01145001|O3|Outcome|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis"
656239|NCT01145001|O2|Outcome|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
656240|NCT01145001|O1|Outcome|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
656241|NCT01145001|E4|Reported Event|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects"
656242|NCT01145001|E3|Reported Event|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis"
656243|NCT01145001|E2|Reported Event|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
656244|NCT01145001|E1|Reported Event|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Contingency Management: incentives given for abstinence based on urine analysis
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
656245|NCT01145053|B1|Baseline|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
656246|NCT01145053|P1|Participant Flow|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
656247|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
656248|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
656249|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
656250|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
656251|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
656254|NCT01145053|E1|Reported Event|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
656255|NCT01145352|B1|Baseline|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
656256|NCT01145352|P1|Participant Flow|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
656257|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
656258|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
656259|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
656260|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
656261|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
656262|NCT01145352|E1|Reported Event|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
656263|NCT01145391|B3|Baseline|Total|Total of all reporting groups
656264|NCT01145391|B2|Baseline|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
656265|NCT01145391|B1|Baseline|Control|Patients receive usual care.
656266|NCT01145391|P2|Participant Flow|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
656267|NCT01145391|P1|Participant Flow|Control|Patients receive usual care.
656268|NCT01145391|O2|Outcome|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
656269|NCT01145391|O1|Outcome|Control|Patients receive usual care.
656270|NCT01145391|O2|Outcome|Usual Care|Usual care
656271|NCT01145391|O1|Outcome|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
656272|NCT01145391|E2|Reported Event|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
656273|NCT01145391|E1|Reported Event|Control|Patients receive usual care.
656274|NCT01145417|B3|Baseline|Total|Total of all reporting groups
656275|NCT01145417|B2|Baseline|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656276|NCT01145417|B1|Baseline|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656277|NCT01145417|P2|Participant Flow|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656278|NCT01145417|P1|Participant Flow|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656279|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656280|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656281|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656282|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656283|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656284|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656285|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656286|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656287|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656288|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656289|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656290|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656315|NCT01145508|B2|Baseline|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
prednisone: Given PO"
656410|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656291|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656292|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656293|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656294|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656295|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656296|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656297|NCT01145417|E2|Reported Event|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656298|NCT01145417|E1|Reported Event|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
656299|NCT01145482|B3|Baseline|Total|Total of all reporting groups
656300|NCT01145482|B2|Baseline|Saline First, Then Insulin|200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin administered once daily on two occasions
657545|NCT01149421|B3|Baseline|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
656301|NCT01145482|B1|Baseline|Insulin First, Then Saline|20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline administered once daily on two occasions
656302|NCT01145482|P2|Participant Flow|Saline First, Then Insulin|200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin once daily on two occasions
656303|NCT01145482|P1|Participant Flow|Insulin First, Then Saline|20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline once daily on two occasions
656304|NCT01145482|O2|Outcome|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
656305|NCT01145482|O1|Outcome|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
656306|NCT01145482|O2|Outcome|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
656307|NCT01145482|O1|Outcome|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
656308|NCT01145482|E2|Reported Event|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
656309|NCT01145482|E1|Reported Event|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
656310|NCT01145495|B1|Baseline|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
lenalidomide: Given orally"
656311|NCT01145495|P1|Participant Flow|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.
>
> rituximab: Given IV
>
> lenalidomide: Given orally"
656312|NCT01145495|O1|Outcome|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
lenalidomide: Given orally"
656313|NCT01145495|E1|Reported Event|Treatment (Lenalidomide, Rituximab)|lenalidomide: Given orally
656316|NCT01145508|B1|Baseline|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
PSA-TRICOM vaccine: Given SC
fowlpox-PSA-TRICOM vaccine: Given SC
docetaxel: Given IV
prednisone: Given PO"
656317|NCT01145508|P2|Participant Flow|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
prednisone: Given PO"
656318|NCT01145508|P1|Participant Flow|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
PSA-TRICOM vaccine: Given SC
fowlpox-PSA-TRICOM vaccine: Given SC
docetaxel: Given IV
prednisone: Given PO"
656319|NCT01145508|O2|Outcome|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
prednisone: Given PO"
656320|NCT01145508|O1|Outcome|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
PSA-TRICOM vaccine: Given SC
fowlpox-PSA-TRICOM vaccine: Given SC
docetaxel: Given IV
prednisone: Given PO"
656321|NCT01145508|E2|Reported Event|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
prednisone: Given PO"
656322|NCT01145508|E1|Reported Event|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
PSA-TRICOM vaccine: Given SC
fowlpox-PSA-TRICOM vaccine: Given SC
docetaxel: Given IV
prednisone: Given PO"
658018|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
656323|NCT01145547|B1|Baseline|All Study Participants|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index and in one experiment, both meals had a high Glycemic Index.
Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
656324|NCT01145547|P2|Participant Flow|High Glycemic Index, Low Glycemic Index|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with high glycemic index followed by a second study consuming meals with a low glycemic index
Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
656325|NCT01145547|P1|Participant Flow|Low Glycemic Index, High Glycemic Index|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with low glycemic index followed by a second study consuming meals with a high glycemic index
Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
656326|NCT01145547|O2|Outcome|High Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
656327|NCT01145547|O1|Outcome|Low Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
656328|NCT01145547|E2|Reported Event|High Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
656329|NCT01145547|E1|Reported Event|Low Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
656330|NCT01145560|B4|Baseline|Total|Total of all reporting groups
656331|NCT01145560|B3|Baseline|Placebo|Saline
656332|NCT01145560|B2|Baseline|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
656333|NCT01145560|B1|Baseline|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
656334|NCT01145560|P3|Participant Flow|Placebo|Saline
656335|NCT01145560|P2|Participant Flow|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
656336|NCT01145560|P1|Participant Flow|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
656337|NCT01145560|O3|Outcome|Placebo|Saline
656338|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
656339|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
656340|NCT01145560|O3|Outcome|Placebo|Saline
656341|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
656342|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
656343|NCT01145560|O3|Outcome|Placebo|Saline
656344|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
656354|NCT01145625|B1|Baseline|2% MTS|"2% Minoxidil Topical Solution
2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
656355|NCT01145625|P2|Participant Flow|5% MTF|"5% Minoxidil Topical Foam
5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
656356|NCT01145625|P1|Participant Flow|2% MTS|"2% Minoxidil Topical Solution
2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
656357|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam
5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
656358|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution
2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
656359|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam
5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
656360|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution
2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
656361|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam
5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
656362|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution
2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
656363|NCT01145625|E2|Reported Event|5% MTF|"5% Minoxidil Topical Foam
5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
656364|NCT01145625|E1|Reported Event|2% MTS|"2% Minoxidil Topical Solution
2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
656365|NCT01145638|B3|Baseline|Total|Total of all reporting groups
656366|NCT01145638|B2|Baseline|Iron Sulphate|"oral iron sulphate twice a day
iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
656367|NCT01145638|B1|Baseline|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion
iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
656368|NCT01145638|P2|Participant Flow|Iron Sulphate|"oral iron sulphate twice a day
iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
656369|NCT01145638|P1|Participant Flow|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion
iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
656370|NCT01145638|O2|Outcome|Iron Sulphate|"oral iron sulphate twice a day
iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
656371|NCT01145638|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion
iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
656372|NCT01145638|O2|Outcome|Iron Sulphate|"oral iron sulphate twice a day
iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
656373|NCT01145638|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion
iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
656374|NCT01145638|E2|Reported Event|Iron Sulphate|"oral iron sulphate twice a day
iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
656375|NCT01145638|E1|Reported Event|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion
iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
656376|NCT01145755|B4|Baseline|Total|Total of all reporting groups
656377|NCT01145755|B3|Baseline|Placebo|Placebo
656378|NCT01145755|B2|Baseline|Duloxetine|Duloxetine 30 mg, 60 mg
656379|NCT01145755|B1|Baseline|AZD2066|AZD2066 12 mg, 18 mg
656380|NCT01145755|P3|Participant Flow|Placebo|Placebo
656381|NCT01145755|P2|Participant Flow|Duloxetine|Duloxetine 30 mg, 60 mg
656382|NCT01145755|P1|Participant Flow|AZD2066|AZD2066 12 mg, 18 mg
656383|NCT01145755|O3|Outcome|Placebo|Placebo
656384|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
656385|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
656386|NCT01145755|O3|Outcome|Placebo|Placebo
656387|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
656388|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
656389|NCT01145755|O3|Outcome|Placebo|Placebo
656390|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
656391|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
656392|NCT01145755|E3|Reported Event|Placebo|Placebo
656393|NCT01145755|E2|Reported Event|Duloxetine|Duloxetine 30 mg, 60 mg
656394|NCT01145755|E1|Reported Event|AZD2066|AZD2066 12 mg, 18 mg
656395|NCT01145898|B3|Baseline|Total|Total of all reporting groups
656396|NCT01145898|B2|Baseline|Prostaglandin Alone|Patients with glaucoma taking prostaglandin alone for at least 6 months
656397|NCT01145898|B1|Baseline|Trusopt|Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months
656398|NCT01145898|P2|Participant Flow|Prostaglandin Alone|Patients with glaucoma taking prostaglandin alone for at least 6 months
656399|NCT01145898|P1|Participant Flow|Trusopt|Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months
656400|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656401|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656402|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656403|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656404|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656405|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656406|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656407|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656408|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656414|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656415|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656416|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656417|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656418|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656419|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656420|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656421|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656422|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656423|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656424|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656425|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656426|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
656427|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
656428|NCT01145898|E1|Reported Event|Glaucoma Patients|Patients with Glaucoma
656438|NCT01146275|P1|Participant Flow|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation.
Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
658296|NCT01152385|O1|Outcome|Arm 1 - High Dose|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
656429|NCT01146054|B1|Baseline|SBRT and Gemzar|"Before stereotactic Body Radiotherapy (SBRT) 3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles should resume/start up to 4 weeks following SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.
Device: CyberKnife based stereotactic radiotherapy"
656430|NCT01146054|P1|Participant Flow|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose 18F-positron emission tomography/computerized tomography) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D (4 dimensional) pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.
Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
656431|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.
Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
656432|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.
Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
656433|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.
Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
656434|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.
Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
656540|NCT01146613|P2|Participant Flow|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
656435|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.
Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
656436|NCT01146054|E1|Reported Event|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.
Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
656437|NCT01146275|B1|Baseline|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation.
Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
656502|NCT01146457|O2|Outcome|Morphine 25|Morphine 25 micrograms
656503|NCT01146457|O1|Outcome|Control|Saline Control
656504|NCT01146457|E5|Reported Event|Morphine 100|Morphine: Active dosage
656439|NCT01146275|O1|Outcome|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation.
Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation"
656440|NCT01146275|O1|Outcome|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation.
Radiologial breast examination : MRI of breast, mammography and ultrasound of breast The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment."
656441|NCT01146275|E1|Reported Event|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane for breast augmentation.
Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
656442|NCT01146288|B3|Baseline|Total|Total of all reporting groups
656443|NCT01146288|B2|Baseline|Furosemide First, Then Acetazolamide|intravenous furosemide 2 mg/5min. in first intervention period, intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
656444|NCT01146288|B1|Baseline|Acetazolamide First, Then Furosemide|intravenous acetazolamide 5 mg/kg/5 min. in first intervention period, intravenous furosemide 2 mg/5min in second intervention period (after washout period).
656445|NCT01146288|P2|Participant Flow|Furosemide First , Than Acetazolamide|Intravenous furosemide 2 mg/5min in first intervention period and intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
656446|NCT01146288|P1|Participant Flow|Acetazolamide First, Then Furosemide|Intravenous acetazolamide 5 mg/kg/5 min. in first intervention period and intravenous furosemide 2 mg/5min in second intervention period (after washout period).
656447|NCT01146288|O2|Outcome|Furosemide|intravenous furosemide 2 mg/5min.
656448|NCT01146288|O1|Outcome|Acetazolamide|intravenous acetazolamide 5 mg/kg/5 min.
656449|NCT01146288|O2|Outcome|Furosemide|intravenous furosemide 2 mg/5min.
656450|NCT01146288|O1|Outcome|Acetazolamide|intravenous acetazolamide 5 mg/kg/5 min.
656451|NCT01146288|E3|Reported Event|P-aminohippuric Acid|Intravenous priming dose of p-aminohippuric acid (8 mg/kg) before diuretics administration
656452|NCT01146288|E2|Reported Event|Furosemide|Intravenous furosemide 2 mg/5min
656453|NCT01146288|E1|Reported Event|Acetazolamide|Intravenous acetazolamide 5 mg/kg/5 min.
656454|NCT01146379|B5|Baseline|Total|Total of all reporting groups
656455|NCT01146379|B4|Baseline|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656456|NCT01146379|B3|Baseline|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656483|NCT01146418|E5|Reported Event|Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants|Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
656541|NCT01146613|P1|Participant Flow|Varenicline|"Varenicline Tartrate
Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
656542|NCT01146613|O2|Outcome|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
656457|NCT01146379|B2|Baseline|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656458|NCT01146379|B1|Baseline|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656459|NCT01146379|P4|Participant Flow|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656460|NCT01146379|P3|Participant Flow|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656505|NCT01146457|E4|Reported Event|Morphine 75|Morphine: Active dosage
656461|NCT01146379|P2|Participant Flow|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656462|NCT01146379|P1|Participant Flow|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656463|NCT01146379|O4|Outcome|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656464|NCT01146379|O3|Outcome|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656465|NCT01146379|O2|Outcome|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656466|NCT01146379|O1|Outcome|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656484|NCT01146418|E4|Reported Event|recFSH 300 IU Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656467|NCT01146379|E4|Reported Event|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656468|NCT01146379|E3|Reported Event|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656469|NCT01146379|E2|Reported Event|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656470|NCT01146379|E1|Reported Event|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
656471|NCT01146418|B3|Baseline|Total|Total of all reporting groups
656472|NCT01146418|B2|Baseline|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656473|NCT01146418|B1|Baseline|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656474|NCT01146418|P4|Participant Flow|recFSH 300 IU Live-Born Infants|Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
656475|NCT01146418|P3|Participant Flow|Corifollitropin Alfa 150 μg Live-Born Infants|Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
656476|NCT01146418|P2|Participant Flow|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656477|NCT01146418|P1|Participant Flow|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656478|NCT01146418|O2|Outcome|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656479|NCT01146418|O1|Outcome|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656480|NCT01146418|O2|Outcome|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656481|NCT01146418|O1|Outcome|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656482|NCT01146418|E6|Reported Event|recFSH 300 IU Follow-up Fetuses/Infants|Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice
656539|NCT01146613|B1|Baseline|Varenicline|"Varenicline Tartrate
Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
656485|NCT01146418|E3|Reported Event|Corifollitropin Alfa 150 μg Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656486|NCT01146418|E2|Reported Event|recFSH 300 IU Participants With ET|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656487|NCT01146418|E1|Reported Event|Corifollitropin Alfa 150 μg Participants With ET|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
656488|NCT01146457|B6|Baseline|Total|Total of all reporting groups
656489|NCT01146457|B5|Baseline|Morphine 100|Morphine 100 micrograms
656490|NCT01146457|B4|Baseline|Hine 75|Morphine 75 micrograms
656491|NCT01146457|B3|Baseline|Morphine 50|Morphine 50 micrograms
656492|NCT01146457|B2|Baseline|Morphine 25|Morphine 25 micrograms
656493|NCT01146457|B1|Baseline|Placebo|Saline control
656494|NCT01146457|P5|Participant Flow|Morphine 100|Morphine 100 micrograms: Active dosage
656495|NCT01146457|P4|Participant Flow|Morphine 75|Morphine 75 micrograms: Active dosage
656496|NCT01146457|P3|Participant Flow|Morphine 50|Morphine 50 micrograms: Active dosage
656497|NCT01146457|P2|Participant Flow|Morphine 25|Morphine 25 micrograms: Active dosage
656498|NCT01146457|P1|Participant Flow|Placebo|Saline: Saline Control
656499|NCT01146457|O5|Outcome|Morphine 100|Morphine 100 micrograms
656500|NCT01146457|O4|Outcome|Morphine 75|Morphine 75 micrograms
656501|NCT01146457|O3|Outcome|Morphine 50|Morphine 50 micrograms
656510|NCT01146600|B2|Baseline|Placebo, Then Clarithromycin|"Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.
Placebo then Clarithromycin : Matched placebo po bid (with breakfast and lunch) for two weeks, then one week with no intervention, then clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks"
656511|NCT01146600|B1|Baseline|Clarithromycin, Then Placebo|"Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.
Clarithromycin followed by placebo : Clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks, then one week with no medication, then matched placebo po bid (with breakfast and lunch) for two weeks."
656512|NCT01146600|P2|Participant Flow|Placebo, Then Clarithromycin|Subjects randomized to receive placebo first (for two weeks), then clarithromycin (for an additional two weeks, following the washout)
656513|NCT01146600|P1|Participant Flow|Clarithromycin, Then Placebo|Subjects randomized to receive clarithromycin first (for two weeks), then matched placebo (for an additional two weeks, following the washout)
656514|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
656515|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
656516|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
656517|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
656518|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
656519|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
656520|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
656521|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
656522|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
656523|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
656524|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
656525|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
656526|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
656527|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
656528|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
656529|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
656530|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
656531|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
656532|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
656533|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
656534|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
656535|NCT01146600|E2|Reported Event|Placebo|Matched placebo with breakfast and with lunch for two weeks
656536|NCT01146600|E1|Reported Event|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
656537|NCT01146613|B3|Baseline|Total|Total of all reporting groups
656538|NCT01146613|B2|Baseline|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
656605|NCT01146860|E1|Reported Event|BNO 1016|sugar coated tablets
656543|NCT01146613|O1|Outcome|Varenicline|"Varenicline Tartrate
Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
656544|NCT01146613|E2|Reported Event|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
656545|NCT01146613|E1|Reported Event|Varenicline|"Varenicline Tartrate
Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
656546|NCT01140347|B3|Baseline|Total|Total of all reporting groups
656547|NCT01140347|B2|Baseline|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656548|NCT01140347|B1|Baseline|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656549|NCT01140347|P2|Participant Flow|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656550|NCT01140347|P1|Participant Flow|Ramucirumab (IMC-1121B) + BSC|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks.
Best supportive care (BSC): Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator."
656551|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656612|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
656552|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656553|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656554|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656555|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656556|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656557|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656558|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656559|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656560|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656561|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656562|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656563|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656564|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656565|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656566|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656567|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656568|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656569|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656570|NCT01140347|E2|Reported Event|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656571|NCT01140347|E1|Reported Event|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
656572|NCT01140360|B1|Baseline|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
656573|NCT01140360|P1|Participant Flow|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
656613|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
656614|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
658297|NCT01152385|E4|Reported Event|Placebo|Placebo
656574|NCT01140360|O1|Outcome|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
656575|NCT01140360|E1|Reported Event|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
656576|NCT01146782|B1|Baseline|Safety Cohort|Demographics and Baseline Characteristics are presented for the Safety Cohort (N=146)
656577|NCT01146782|P1|Participant Flow|Sleep Apnea Treatment (Primary Endpoint Cohort)|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) polysomnogram (PSG).
656578|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
656579|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
656580|NCT01146782|O1|Outcome|Safety Cohort|The Safety Cohort is comprised of all subjects with at least one night of Winx therapy usage.
656581|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
656582|NCT01146782|E1|Reported Event|Safety Cohort|Device related adverse events are presented for the Safety Cohort.
656583|NCT01146808|B1|Baseline|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
656584|NCT01146808|P1|Participant Flow|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
656585|NCT01146808|O1|Outcome|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
656586|NCT01146808|O1|Outcome|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
656587|NCT01146808|O1|Outcome|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
656588|NCT01146808|E1|Reported Event|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
656589|NCT01146860|B3|Baseline|Total|Total of all reporting groups
656590|NCT01146860|B2|Baseline|Placebo|sugar coated tablets
656591|NCT01146860|B1|Baseline|BNO 1016|sugar coated tablets
656592|NCT01146860|P2|Participant Flow|Placebo|sugar coated tablets of identical appearance to active treatment
656593|NCT01146860|P1|Participant Flow|BNO 1016|sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; daily dose: 480 mg (2 tablets tid)
656594|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
656595|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
656596|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
656597|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
656598|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
656599|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
656600|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
656601|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
656602|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
656603|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
656604|NCT01146860|E2|Reported Event|Placebo|sugar coated tablets
656607|NCT01146873|B2|Baseline|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
656608|NCT01146873|B1|Baseline|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
656609|NCT01146873|P2|Participant Flow|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
656610|NCT01146873|P1|Participant Flow|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
656611|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
658298|NCT01152385|E3|Reported Event|Low Dose|80 mg (daily dose)
656615|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
656616|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
656617|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
656618|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
656619|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
656620|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
656621|NCT01146873|E2|Reported Event|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
656622|NCT01146873|E1|Reported Event|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher
656623|NCT01146912|B8|Baseline|Total|Total of all reporting groups
656624|NCT01146912|B7|Baseline|Delayed Pediatrics: Usual Care|
656625|NCT01146912|B6|Baseline|Delayed Pediatrics: Conventional Text Message|
656626|NCT01146912|B5|Baseline|Delayed Pediatrics: Interactive Text Message|
656627|NCT01146912|B4|Baseline|Pregnant Women: Usual Care|
656628|NCT01146912|B3|Baseline|Pregnant Women: Text Message|
656629|NCT01146912|B2|Baseline|Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
656630|NCT01146912|B1|Baseline|Text Message Vaccine Reminders/Automated Telephone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
656631|NCT01146912|P8|Participant Flow|Parents|Included in enrollment but not in outcomes which are on child level
656632|NCT01146912|P7|Participant Flow|Delayed Pediatric: Usual Care|Vaccination of children not yet vaccinated by mid-November: usual care
656633|NCT01146912|P6|Participant Flow|Delayed Pediatric: Conventional Text Message|Vaccination of children not yet vaccinated by mid-November: conventional text message
656634|NCT01146912|P5|Participant Flow|Delayed Pediatrics: Interactive Text Message Vaccine Reminders|Vaccination of children not yet vaccinated by mid-November: interactive message
656635|NCT01146912|P4|Participant Flow|Pregnant Women: Usual Care|Received usual care
656636|NCT01146912|P3|Participant Flow|Pregnant Women: Text Message|Received text message reminders
656637|NCT01146912|P2|Participant Flow|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
656638|NCT01146912|P1|Participant Flow|Pediatric Text Message Vaccine Reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
656639|NCT01146912|O3|Outcome|Delayed Pediatric: Usual Care|Vaccination of children not yet vaccinated by mid-November: usual care
656640|NCT01146912|O2|Outcome|Delayed Pediatric: Conventional Text Message|Vaccination of children not yet vaccinated by mid-November: conventional text message
656641|NCT01146912|O1|Outcome|Delayed Pediatrics: Interactive Text Message Vaccine Reminders|Vaccination of children not yet vaccinated by mid-November: interactive message
656642|NCT01146912|O2|Outcome|Pregnant Women: Usual Care|
656643|NCT01146912|O1|Outcome|Pregnant Women: Text Message|
656644|NCT01146912|O2|Outcome|Automated Phone Call From Clinic|"Receipt of automated phone call from clinic
automated call: Automated call"
656645|NCT01146912|O1|Outcome|Text Message Vaccine Reminders|"Receipt of text message vaccine reminders
Text Message: Text message vaccine reminders
automated call: Automated call"
656646|NCT01146912|O2|Outcome|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
656647|NCT01146912|O1|Outcome|Pediatric: Text Message Vaccine Reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
656648|NCT01146912|O2|Outcome|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
656649|NCT01146912|O1|Outcome|Pediatric: Text Message Vaccine-reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
656650|NCT01146912|E7|Reported Event|Delayed Pediatric: Usual Care|
656651|NCT01146912|E6|Reported Event|Delayed Pediatric: Conventional Text Message|
656652|NCT01146912|E5|Reported Event|Delayed Pediatric: Interactive Text Message|
656653|NCT01146912|E4|Reported Event|Pregnant Women: Usual Care|
656654|NCT01146912|E3|Reported Event|Pregnant Women: Text Message|
656655|NCT01146912|E2|Reported Event|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
656656|NCT01146912|E1|Reported Event|Pediatric: Text Message Vaccine-reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
656657|NCT01146951|B3|Baseline|Total|Total of all reporting groups
656658|NCT01146951|B2|Baseline|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
656659|NCT01146951|B1|Baseline|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
656660|NCT01146951|P2|Participant Flow|Placebo|Placebo : Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
656661|NCT01146951|P1|Participant Flow|Rufinamide (E2080)|"Rufinamide : Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.
Target maintenance dose:
15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)"
656662|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
656663|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
656664|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
656665|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
656666|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
656667|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
656668|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
656669|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
656670|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
656671|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
656791|NCT01147406|P5|Participant Flow|Cohort 6|35 mg of N6022 was given intravenously daily for 7 days
656672|NCT01146951|E2|Reported Event|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
656673|NCT01146951|E1|Reported Event|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
656674|NCT01147172|B1|Baseline|Elevess|"Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite
Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles"
656675|NCT01147172|P1|Participant Flow|Elevess|"Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite
Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles"
656676|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
656677|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
656678|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
656679|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
656680|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation at End of Study.
656681|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
656682|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
656683|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
656684|NCT01147172|E1|Reported Event|Safety Population|All Subjects receiving treatment of nasolabial folds (NLF) with injection of Elevess.
656685|NCT01147250|B3|Baseline|Total|Total of all reporting groups
656686|NCT01147250|B2|Baseline|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
656687|NCT01147250|B1|Baseline|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
656688|NCT01147250|P2|Participant Flow|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
656689|NCT01147250|P1|Participant Flow|Placebo|Placebo matched to lixisenatide once daily (QD) subcutaneously (SC) up to end of treatment (median exposure: 23 months).
656690|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
656691|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
656692|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
656693|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
656694|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
656695|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
656696|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
656697|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
656698|NCT01147250|E2|Reported Event|Lixisenatide|Participants exposed to Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to 225 weeks. (Median exposure: 22 months)
656699|NCT01147250|E1|Reported Event|Placebo|Participants exposed to Placebo matched to lixisenatide QD. (Median exposure: 23 months)
656700|NCT01147302|B3|Baseline|Total|Total of all reporting groups
656701|NCT01147302|B2|Baseline|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656702|NCT01147302|B1|Baseline|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656703|NCT01147302|P2|Participant Flow|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656704|NCT01147302|P1|Participant Flow|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656705|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656706|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656707|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656708|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656709|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656710|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656711|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656712|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656713|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656714|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656715|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656716|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656717|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656718|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656719|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656720|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656721|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656722|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656723|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656724|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656725|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656726|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656727|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656728|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656729|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656730|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656731|NCT01147302|E2|Reported Event|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
656732|NCT01147302|E1|Reported Event|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
656733|NCT01147341|B3|Baseline|Total|Total of all reporting groups
656734|NCT01147341|B2|Baseline|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656735|NCT01147341|B1|Baseline|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656736|NCT01147341|P2|Participant Flow|Placebo|"Reporting group: Placebo : prefilled saline syringe during the Double Blind Period
10 patients entered"
656956|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656737|NCT01147341|P1|Participant Flow|Active Treatment With Cimzia|"Reporting group: Cimzia : prefilled 200mg Cimzia syringes. Cimzia 400mg SC at baseline, weeks 2 and 4 and Cimzia 200mg SC at weeks 6, 8, and 10 during the Double Blind Portion.
Cimzia 400mg SC at weeks 12, 14, and 16 and Cimzia 200mg SC at weeks 18, 20, and 22.
27 patients entered the Double Blind Portion."
656738|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656739|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656740|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656741|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656742|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656743|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656744|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656745|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656746|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656747|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656748|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656749|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656750|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656751|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656752|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656753|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656754|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656755|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656756|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656757|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656758|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656759|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656760|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656761|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656762|NCT01147341|E2|Reported Event|Placebo|"Placebo : prefilled saline syringe
10 patients entered"
656763|NCT01147341|E1|Reported Event|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks
27 patients entered"
656764|NCT01147380|B3|Baseline|Total|Total of all reporting groups
656765|NCT01147380|B2|Baseline|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
656766|NCT01147380|B1|Baseline|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
656767|NCT01147380|P2|Participant Flow|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells
Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation."
656768|NCT01147380|P1|Participant Flow|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.
Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation."
656792|NCT01147406|P4|Participant Flow|Cohort 5|25 mg of N6022 was given intravenously daily for 7 days
656769|NCT01147380|O2|Outcome|Large Dose|"From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells(mainly NK cells) is between 100 and 1000 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate.Patient of this arm receive large dose of liver NK cell inoculation as described.
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
656770|NCT01147380|O1|Outcome|Small Dose|"From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells( mainly NK cells) is between 10 and 100 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate. Patient of this arm receive small dose of liver NK cell inoculation as described.
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
656771|NCT01147380|O2|Outcome|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
656772|NCT01147380|O1|Outcome|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
656773|NCT01147380|E2|Reported Event|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
656774|NCT01147380|E1|Reported Event|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
656815|NCT01147458|P4|Participant Flow|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
656775|NCT01147393|B1|Baseline|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.
90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.
veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
656776|NCT01147393|P1|Participant Flow|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.
90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.
veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
656777|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.
90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.
veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
656778|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.
90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.
veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
656779|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.
90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.
veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
656780|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.
90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.
veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
656781|NCT01147393|E2|Reported Event|Dose Level -1|veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 10 mCi/m2
656782|NCT01147393|E1|Reported Event|Dose Level 1|veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 15 mCi/m2
656783|NCT01147406|B7|Baseline|Total|Total of all reporting groups
656784|NCT01147406|B6|Baseline|Placebo|Not Active - Placebo
656785|NCT01147406|B5|Baseline|Cohort 6|N6022 - Active 35 mg
656786|NCT01147406|B4|Baseline|Cohort 5|N6022 - Active 25 mg
656787|NCT01147406|B3|Baseline|Cohort 3|N6022 - Active 45 mg (actual *27.5 mg)
656788|NCT01147406|B2|Baseline|Cohort 2 & 4|N6022 - Active 15 mg
656789|NCT01147406|B1|Baseline|Cohort 1|N6022 - Active 5 mg
656793|NCT01147406|P3|Participant Flow|Cohort 3|45 mg of N6022 was to be given intravenously daily for 7 days however, the actual amount was 27.5 mg.
656794|NCT01147406|P2|Participant Flow|Cohorts 2 and 4|15 mg of N6022 was given intravenously daily for 7 days
656795|NCT01147406|P1|Participant Flow|Cohort 1|5 mg of N6022 was given intravenously daily for 7 days
656796|NCT01147406|O6|Outcome|Placebo|Not Active - Placebo
656797|NCT01147406|O5|Outcome|Cohort 6|N6022 - Active 35 mg
656798|NCT01147406|O4|Outcome|Cohort 5|N6022 - Active 25 mg
656799|NCT01147406|O3|Outcome|Cohort 3|N6022 - Active 45 mg (actual *27.5 mg)
656800|NCT01147406|O2|Outcome|Cohort 2 and 4|N6022 - Active 15 mg
656801|NCT01147406|O1|Outcome|Cohort 1|N6022 - Active 5 mg
656802|NCT01147406|O6|Outcome|Placebo|Not Active - Placebo
656803|NCT01147406|O5|Outcome|Cohort 6|N6022 - Active 35 mg
656804|NCT01147406|O4|Outcome|Cohort 5|N6022 - Active 25 mg
656805|NCT01147406|O3|Outcome|Cohort 3|N6022 - Active 45 mg
656806|NCT01147406|O2|Outcome|Cohort 2 and 4|N6022 - Active 15 mg
656807|NCT01147406|O1|Outcome|Cohort 1|N6022 - Active 5 mg
656808|NCT01147406|E6|Reported Event|Placebo|Not Active - Placebo
656809|NCT01147406|E5|Reported Event|Cohort 6|N6022 - Active 35 mg
656810|NCT01147406|E4|Reported Event|Cohort 5|N6022 - Active 25 mg
656811|NCT01147406|E3|Reported Event|Cohort 3|N6022 - Active 45 mg
656812|NCT01147406|E2|Reported Event|Cohort 2 and 4|N6022 - Active 15 mg
656813|NCT01147406|E1|Reported Event|Cohort 1|N6022 - Active 5 mg
656814|NCT01147458|B1|Baseline|Entire Study Population|Includes groups randomized to receive PF-04191834 first, placebo first, PF-04191834 plus naproxen first, and naproxen first.
656816|NCT01147458|P3|Participant Flow|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
656817|NCT01147458|P2|Participant Flow|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
656818|NCT01147458|P1|Participant Flow|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
656819|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
656820|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
656821|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
656822|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
656823|NCT01147458|O2|Outcome|PF-04191834 600 mg BID + Naproxen 500 mg BID|PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2
656824|NCT01147458|O1|Outcome|PF-04191834 600 mg BID|PF-04191834 600 mg BID administered either in Period 1 or Period 2
656825|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
656826|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
656827|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
656828|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
656829|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
656830|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
656831|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
656832|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
656833|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
656834|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
656835|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
656836|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
656837|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
656838|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
656839|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
656840|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
656841|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
656842|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
656843|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
656844|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
656845|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
658299|NCT01152385|E2|Reported Event|Middle Dose|140 mg (daily dose)
656846|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
656847|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
656848|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
656849|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
656850|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
656851|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
656852|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
656853|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
656854|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
656855|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
656856|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
656857|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
656858|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
656859|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
656860|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
656861|NCT01147458|E4|Reported Event|Naproxen|Naproxen 500 mg BID administered either in Period 1 or Period 2
656862|NCT01147458|E3|Reported Event|PF-04191834 + Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2
656863|NCT01147458|E2|Reported Event|Placebo|Placebo administered either in Period 1 or Period 2
656864|NCT01147458|E1|Reported Event|PF-04191834|PF-04191834 600 mg BID administered either in Period 1 or Period 2
656865|NCT01147471|B3|Baseline|Total|Total of all reporting groups
656866|NCT01147471|B2|Baseline|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):
a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
656902|NCT01147601|E2|Reported Event|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
Control (placebo) group: Control (placebo) group"
656903|NCT01147601|E1|Reported Event|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.
topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
656867|NCT01147471|B1|Baseline|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.
Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.
operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
656868|NCT01147471|P2|Participant Flow|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):
a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
656869|NCT01147471|P1|Participant Flow|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.
Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.
operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
657968|NCT01143792|E1|Reported Event|CRA + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
656870|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):
a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
656871|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.
Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.
operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
656872|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):
a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
656873|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.
Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.
operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
656874|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):
a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
656875|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.
Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.
operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
656876|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):
a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
656877|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.
Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.
operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
656878|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):
a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
656879|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.
Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.
operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
657374|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
656880|NCT01147471|E2|Reported Event|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):
a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
656881|NCT01147471|E1|Reported Event|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize stove-in segment. Post-operatively, the patients would receive standard of care, similar to what is outlined for the non-operative arm.
Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.
operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system.
operative rib fix"
656882|NCT01147497|B3|Baseline|Total|Total of all reporting groups
656883|NCT01147497|B2|Baseline|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
656884|NCT01147497|B1|Baseline|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
656885|NCT01147497|P2|Participant Flow|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
656886|NCT01147497|P1|Participant Flow|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
656887|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
656888|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
656889|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
656890|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
656891|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
656892|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
656893|NCT01147497|E2|Reported Event|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
656894|NCT01147497|E1|Reported Event|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
656895|NCT01147601|B3|Baseline|Total|Total of all reporting groups
656896|NCT01147601|B2|Baseline|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
Control (placebo) group: Control (placebo) group"
656897|NCT01147601|B1|Baseline|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.
topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
656898|NCT01147601|P2|Participant Flow|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
Control (placebo) group: Control (placebo) group"
656899|NCT01147601|P1|Participant Flow|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.
topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
656900|NCT01147601|O2|Outcome|Placebo|"Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
Control (placebo) group: Control (placebo) group"
656901|NCT01147601|O1|Outcome|Topical 0.5% Timolol|"Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.
topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily"
656908|NCT01147627|P3|Participant Flow|Pioglitazone|Pioglitazone was commenced at a dose of 30 mg daily, increasing to 45 mg daily after 4 weeks.
656909|NCT01147627|P2|Participant Flow|Premixed Insulin Analog|Premixed insulin was injected twice-daily commencing with 0.4 IU/kg daily, with 50% given 15 minutes before breakfast and dinner respectively
656910|NCT01147627|P1|Participant Flow|Exenatide|5 µg was injected twice-daily subcutaneously increasing to 10 µg twice-daily after 4 weeks. Those who experienced hypoglycaemia frequently or could not tolerate adverse events were instructed to reduce the dose to 5 µg twice-daily.
656911|NCT01147627|O3|Outcome|Thiazolidinedione|
656912|NCT01147627|O2|Outcome|Premixed Insulin Analog|
656913|NCT01147627|O1|Outcome|Exenatide|
656914|NCT01147627|E3|Reported Event|Thiazolidinedione|
656915|NCT01147627|E2|Reported Event|Premixed Insulin Analog|
656916|NCT01147627|E1|Reported Event|Exenatide|
656917|NCT01147640|B3|Baseline|Total|Total of all reporting groups
656918|NCT01147640|B2|Baseline|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
656919|NCT01147640|B1|Baseline|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
656920|NCT01147640|P2|Participant Flow|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
658010|NCT01144026|O1|Outcome|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
656921|NCT01147640|P1|Participant Flow|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
656922|NCT01147640|O2|Outcome|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
656923|NCT01147640|O1|Outcome|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
656924|NCT01147640|O2|Outcome|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
656925|NCT01147640|O1|Outcome|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
656926|NCT01147640|E2|Reported Event|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
656927|NCT01147640|E1|Reported Event|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
656928|NCT01147653|B3|Baseline|Total|Total of all reporting groups
656929|NCT01147653|B2|Baseline|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood at Year 1.
656930|NCT01147653|B1|Baseline|Autologous UCB First, Then Placebo|Subjects receive autologous umbilical cord blood at Baseline, then Placebo at Year 1.
656931|NCT01147653|P2|Participant Flow|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood at Year 1.
656932|NCT01147653|P1|Participant Flow|Autologous UCB Reinfusion First, Then Placebo|Subjects receive autologous umbilical cord blood at Baseline, then Placebo at Year 1.
656933|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.
Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
656934|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second.
656935|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second.
656936|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656937|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656938|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656939|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656940|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656941|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656942|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656943|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656944|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656945|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656946|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656947|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656948|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656949|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656950|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656951|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656952|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656953|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656954|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656955|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
658300|NCT01152385|E1|Reported Event|High Dose|200 mg (daily dose)
656957|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656958|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656959|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656960|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656961|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656962|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656963|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656964|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656965|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656966|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656967|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656968|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656969|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than Placebo at Year 1.
656970|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo first, then autologous umbilical cord blood cell reinfusion at Year 1.
656971|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells first, than placebo at Year 1.
656972|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656973|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656974|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656975|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656976|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo first, then autologous umbilical cord blood cell reinfusion at Year 1.
656977|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells first, than placebo at Year 1.
656978|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656979|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656980|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656981|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
656982|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
656983|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
657003|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657531|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
656984|NCT01147653|E2|Reported Event|Placebo|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.
Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
656985|NCT01147653|E1|Reported Event|Autologous Umbilical Cord Blood Reinfusion|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.
Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
656986|NCT01147809|B7|Baseline|Total|Total of all reporting groups
656987|NCT01147809|B6|Baseline|Phase II: Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
656988|NCT01147809|B5|Baseline|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657247|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
656989|NCT01147809|B4|Baseline|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
656990|NCT01147809|B3|Baseline|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
656991|NCT01147809|B2|Baseline|Phase I: 21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
656992|NCT01147809|B1|Baseline|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
656993|NCT01147809|P6|Participant Flow|Phase II: Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
656994|NCT01147809|P5|Participant Flow|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
656995|NCT01147809|P4|Participant Flow|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
656996|NCT01147809|P3|Participant Flow|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
656997|NCT01147809|P2|Participant Flow|Phase I: 21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
656998|NCT01147809|P1|Participant Flow|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
656999|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657000|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657001|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657002|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657004|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657005|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657006|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657007|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657008|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657009|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657010|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657011|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657012|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657013|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657014|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657015|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657016|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657017|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657018|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657019|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657020|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657021|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657022|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657023|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657024|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657025|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657026|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657027|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657028|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657029|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657030|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
658301|NCT01152437|B4|Baseline|Total|Total of all reporting groups
657031|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657032|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657033|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657034|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657035|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657036|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657037|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657038|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657039|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657040|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657041|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657042|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657043|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657044|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657045|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657583|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657046|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657047|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657048|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657049|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657050|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657051|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657052|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657053|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657054|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657055|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657056|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657057|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657058|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657059|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657060|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657061|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657062|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657063|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657064|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657065|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg)|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657066|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657067|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657068|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657069|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657070|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657071|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657072|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657073|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657140|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657074|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657075|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657076|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657077|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657078|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657079|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657080|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657081|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657082|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657083|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657084|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657085|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657086|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657087|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657088|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657089|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657090|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657091|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657092|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657093|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657094|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657095|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657096|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657097|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657098|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657099|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657100|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657101|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657102|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657103|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657104|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657105|NCT01147809|E6|Reported Event|Phase II: Eltrombopag|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657106|NCT01147809|E5|Reported Event|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
657107|NCT01147809|E4|Reported Event|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657108|NCT01147809|E3|Reported Event|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657109|NCT01147809|E2|Reported Event|Phase I: 21-Day Cycle Eltrombopag|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657131|NCT01147848|P3|Participant Flow|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657110|NCT01147809|E1|Reported Event|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
657111|NCT01147822|B3|Baseline|Total|Total of all reporting groups
657112|NCT01147822|B2|Baseline|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657113|NCT01147822|B1|Baseline|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657114|NCT01147822|P2|Participant Flow|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657115|NCT01147822|P1|Participant Flow|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657116|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657141|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657117|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657118|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657119|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657120|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657121|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657122|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657123|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657124|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657125|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657126|NCT01147822|E2|Reported Event|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657127|NCT01147822|E1|Reported Event|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
657128|NCT01147848|B3|Baseline|Total|Total of all reporting groups
657129|NCT01147848|B2|Baseline|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657130|NCT01147848|B1|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657132|NCT01147848|P2|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657133|NCT01147848|P1|Participant Flow|Fluticasone Propionate 250 µg BID|Participants received Fluticasone Propionate 250 micrograms (µg) twice a day (BID) and salbutamol/albuterol as required to control symptoms.
657134|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657135|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657136|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657137|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657138|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657139|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657246|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657142|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657143|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657144|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657145|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657146|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657147|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657148|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657149|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657150|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657151|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657152|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657153|NCT01147848|O1|Outcome|FFluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657154|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657155|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657156|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657157|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657158|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657232|NCT01147926|B3|Baseline|Total|Total of all reporting groups
657358|NCT01148524|B1|Baseline|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
657159|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657160|NCT01147848|E2|Reported Event|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
657161|NCT01147848|E1|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
657162|NCT01147874|B1|Baseline|All Participants|Participants with psoriasis were observed for 8 weeks.
657163|NCT01147874|P1|Participant Flow|All Participants|Participants with psoriasis were observed for 8 weeks.
657164|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
657165|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
657166|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
657167|NCT01147874|E1|Reported Event|All Participants|Participants with psoriasis were observed for 8 weeks.
657168|NCT01147900|B4|Baseline|Total|Total of all reporting groups
657169|NCT01147900|B3|Baseline|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657248|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
658011|NCT01144026|E2|Reported Event|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
657170|NCT01147900|B2|Baseline|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657171|NCT01147900|B1|Baseline|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657172|NCT01147900|P3|Participant Flow|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657173|NCT01147900|P2|Participant Flow|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657174|NCT01147900|P1|Participant Flow|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657175|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657176|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
658235|NCT01152294|O1|Outcome|Control|Group not receiving the decision aid (DVD and booklet)
657177|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657178|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657179|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657180|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657181|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657182|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657183|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657184|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657185|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657186|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657187|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657188|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657189|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657190|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657191|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657192|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657193|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657194|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657195|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657196|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657197|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657198|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657199|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657200|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657201|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657202|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657203|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657204|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657205|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657206|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657207|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657208|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657209|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657210|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657211|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657212|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657213|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657214|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657215|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657216|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657217|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657218|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657219|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657220|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657221|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657222|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657223|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657224|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657225|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657226|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657227|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657228|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657229|NCT01147900|E3|Reported Event|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657230|NCT01147900|E2|Reported Event|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657231|NCT01147900|E1|Reported Event|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
657233|NCT01147926|B2|Baseline|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657234|NCT01147926|B1|Baseline|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657235|NCT01147926|P2|Participant Flow|PRUCALOPRIDE|Prucalopride 2 milligram (mg) tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657236|NCT01147926|P1|Participant Flow|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657237|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657238|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657239|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657240|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657241|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657242|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657243|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657244|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657245|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657249|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657250|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657251|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657252|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657253|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657254|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657255|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657256|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657257|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657258|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657259|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657260|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657261|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657262|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657263|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657264|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657265|NCT01147926|E2|Reported Event|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to less than <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
657266|NCT01147926|E1|Reported Event|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
657267|NCT01148017|B5|Baseline|Total|Total of all reporting groups
657268|NCT01148017|B4|Baseline|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
657269|NCT01148017|B3|Baseline|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
657270|NCT01148017|B2|Baseline|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657271|NCT01148017|B1|Baseline|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657272|NCT01148017|P4|Participant Flow|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
657273|NCT01148017|P3|Participant Flow|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
657274|NCT01148017|P2|Participant Flow|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657275|NCT01148017|P1|Participant Flow|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657276|NCT01148017|O4|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
657277|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
657278|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657279|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657280|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
657281|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657282|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657283|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
657284|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657373|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
657285|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657286|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
657287|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657288|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657289|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
657290|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657291|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657292|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
657293|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657294|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657295|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
657296|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657297|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657298|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
657299|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657300|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657301|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
657302|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657303|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657304|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
657305|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657359|NCT01148524|P9|Participant Flow|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
657306|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657307|NCT01148017|E4|Reported Event|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
657308|NCT01148017|E3|Reported Event|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
657309|NCT01148017|E2|Reported Event|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
657310|NCT01148017|E1|Reported Event|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
657311|NCT01148056|B1|Baseline|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
657312|NCT01148056|P1|Participant Flow|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
657313|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
657314|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
657315|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
657316|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
658666|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
657317|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
657318|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
657319|NCT01148056|E1|Reported Event|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
657320|NCT01148420|B1|Baseline|DMPA + MPA|
657321|NCT01148420|P1|Participant Flow|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
657322|NCT01148420|O1|Outcome|DMPA + MPA|
657323|NCT01148420|O1|Outcome|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
657324|NCT01148420|O1|Outcome|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
657325|NCT01148420|E1|Reported Event|DMPA & High Dose MPA|DMPA & High Dose MPA
657326|NCT01148511|B3|Baseline|Total|Total of all reporting groups
657327|NCT01148511|B2|Baseline|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
657328|NCT01148511|B1|Baseline|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
657329|NCT01148511|P3|Participant Flow|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
657330|NCT01148511|P2|Participant Flow|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
657331|NCT01148511|P1|Participant Flow|All Patients|All 99 patients were exposed to study drug. 93 of the 99 patients were randomized into the Treat and Extend and the Treat and Observe treatment groups.
657332|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
657333|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
657334|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
657335|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
657336|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
657337|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
657338|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
657339|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
657340|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
658012|NCT01144026|E1|Reported Event|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
657341|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
657342|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
657343|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
657344|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
657345|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
657346|NCT01148511|E3|Reported Event|Before Randomization|These 6 patients were exposed to study drug but discontinued from the study prior to randomization.
657347|NCT01148511|E2|Reported Event|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
657348|NCT01148511|E1|Reported Event|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
657349|NCT01148524|B10|Baseline|Total|Total of all reporting groups
657350|NCT01148524|B9|Baseline|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
657351|NCT01148524|B8|Baseline|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
657352|NCT01148524|B7|Baseline|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
657353|NCT01148524|B6|Baseline|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
657354|NCT01148524|B5|Baseline|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
657355|NCT01148524|B4|Baseline|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
657356|NCT01148524|B3|Baseline|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
657357|NCT01148524|B2|Baseline|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
657360|NCT01148524|P8|Participant Flow|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
657361|NCT01148524|P7|Participant Flow|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
657362|NCT01148524|P6|Participant Flow|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
657363|NCT01148524|P5|Participant Flow|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
657364|NCT01148524|P4|Participant Flow|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
657365|NCT01148524|P3|Participant Flow|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
657366|NCT01148524|P2|Participant Flow|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
657367|NCT01148524|P1|Participant Flow|rMenB06|Subjects who had received 2 doses each of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB+OMV-NZ) (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
657368|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
657369|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
657370|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
657371|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
657372|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
657375|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
657376|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
657377|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
657378|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
657379|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
657380|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
657381|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
657382|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
657383|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
657384|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
657385|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
657386|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
657387|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
657388|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
657389|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
657390|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
657391|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
657392|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
657393|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
657394|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
657395|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
657396|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
657397|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
657398|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
657399|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
657400|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
657401|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
657402|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
657403|NCT01148524|E9|Reported Event|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
657452|NCT01148745|E1|Reported Event|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
657404|NCT01148524|E8|Reported Event|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
657405|NCT01148524|E7|Reported Event|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
657406|NCT01148524|E6|Reported Event|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
657407|NCT01148524|E5|Reported Event|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
657408|NCT01148524|E4|Reported Event|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
657409|NCT01148524|E3|Reported Event|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
657410|NCT01148524|E2|Reported Event|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
657411|NCT01148524|E1|Reported Event|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
657412|NCT01148537|B4|Baseline|Total|Total of all reporting groups
657413|NCT01148537|B3|Baseline|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
657414|NCT01148537|B2|Baseline|Placebo|Matching placebo transdermal patches.
657415|NCT01148537|B1|Baseline|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
657416|NCT01148537|P3|Participant Flow|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
657417|NCT01148537|P2|Participant Flow|Placebo|Matching placebo transdermal patches.
657465|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
657546|NCT01149421|B2|Baseline|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
658013|NCT01144052|B3|Baseline|Total|Total of all reporting groups
657418|NCT01148537|P1|Participant Flow|BTDS|"Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h. Randomization was from predose on day 1 to predose on day 14. There were 3 treatment groups: BTDS, placebo, and moxifloxacin as the positive control. The treatment groups between placebo and BTDS were double-blinded. Moxifloxacin treatment was open label to subjects, to the investigator, and the staff at the study site.
BTDS or placebo TDS was applied on day 1 for 3 days (BTDS 5), on day 4 for 3 days (BTDS 10), on day 7 for 3 days (BTDS 20), and on day 10 for 4 days (2 * BTDS 20). On day 6 and day 13, subjects in the positive control group received one 400 mg tablet of moxifloxacin."
657419|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
657420|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
657421|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
657422|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
657423|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
657424|NCT01148537|O1|Outcome|Mofloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
657425|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
657426|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
657427|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
657428|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
657429|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
657430|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
657431|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
657432|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
657433|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
657434|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
657435|NCT01148537|E3|Reported Event|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
657436|NCT01148537|E2|Reported Event|Placebo|Matching placebo transdermal patches.
657437|NCT01148537|E1|Reported Event|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
657438|NCT01148693|B3|Baseline|Total|Total of all reporting groups
657439|NCT01148693|B2|Baseline|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
657440|NCT01148693|B1|Baseline|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
657441|NCT01148693|P2|Participant Flow|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
657442|NCT01148693|P1|Participant Flow|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
657443|NCT01148693|O2|Outcome|Placebo|patients for whom distilled water is added to contrast during ERCP
657444|NCT01148693|O1|Outcome|Gentamicin|patients for whom 10m/10cc of gentamicin is added to contrast during ERCP
657445|NCT01148693|E2|Reported Event|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
657446|NCT01148693|E1|Reported Event|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
657447|NCT01148745|B1|Baseline|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
657448|NCT01148745|P1|Participant Flow|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
657449|NCT01148745|O1|Outcome|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
657450|NCT01148745|O1|Outcome|Ferumoxytol 510 mg|2 doses of 510 mg IV over 17 seconds separated by 3 days
657451|NCT01148745|O1|Outcome|Ferumoxytol|All participants received 510 mg IV ferumoxytol at both visits 1 and 2.
657454|NCT01148771|B2|Baseline|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
657455|NCT01148771|B1|Baseline|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
657456|NCT01148771|P2|Participant Flow|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
657457|NCT01148771|P1|Participant Flow|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
657458|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses.
657459|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
657460|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|This is a simulated population of 5000 patients receiving ertapenem 1 gram every 24 hours as a 30 minute IV infusion.
657461|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|This is a simulated population of 5000 patients receiving ertapenem 1 gram every 24 hours as a 5 minute IV bolus.
657462|NCT01148771|O2|Outcome|Ertapenem IV 30 Minute Infusion|
657463|NCT01148771|O1|Outcome|Ertapenem IV 5 Minute Bolus|
657464|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses.
657466|NCT01148771|E2|Reported Event|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
657467|NCT01148771|E1|Reported Event|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
657468|NCT01148836|B3|Baseline|Total|Total of all reporting groups
657469|NCT01148836|B2|Baseline|Pulmonary Hypertension Subjects|
657470|NCT01148836|B1|Baseline|Healthy Controls Subjects|
657471|NCT01148836|P2|Participant Flow|Pulmonary Hypertension Subjects (Disease)|
657472|NCT01148836|P1|Participant Flow|Healthy Controls|
657473|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
657474|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
657475|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
657476|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
657477|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
657478|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
657479|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
657480|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
657481|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
657482|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
657483|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
657484|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
657485|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
657486|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
657487|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
657488|NCT01148836|E2|Reported Event|Coenzyme Q and Healthy Controls|Healthy Control subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
657489|NCT01148836|E1|Reported Event|Coenzyme Q and Pulmonary Hypertension|Pulmonary Hypertension subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
657490|NCT01148862|B1|Baseline|Entire Study Population|Includes groups randomized to LGS on first and LGS off first
657491|NCT01148862|P2|Participant Flow|LGS Off First, Then LGS on|LGS off first, then LGS on group will wear the MiniMed Paradigm® X54 System with Low Glucose Suspend (LGS) turned 'OFF' first, then LGS turned on 'ON' after crossing over
657492|NCT01148862|P1|Participant Flow|LGS on First, Then LGS Off|LGS on first, then LGS off group will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature turned 'ON' first, then LGS turned 'OFF' after crossing over
657493|NCT01148862|O2|Outcome|LGS Off: Without Low Glucose Suspend (LGS) Feature|LGS off: Without Low Glucose Suspend (LGS) feature
657494|NCT01148862|O1|Outcome|LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'|LGS on: Low Glucose Suspend (LGS) feature turned 'ON'
657495|NCT01148862|O2|Outcome|LGS Off: Without Low Glucose Suspend (LGS) Feature|LGS off: Without Low Glucose Suspend (LGS) feature
657496|NCT01148862|O1|Outcome|LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'|LGS on: Low Glucose Suspend (LGS) feature turned 'ON'
657497|NCT01148862|E2|Reported Event|LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'|
657498|NCT01148862|E1|Reported Event|LGS Off: Without Low Glucose Suspend (LGS) Feature|
657499|NCT01148979|B3|Baseline|Total|Total of all reporting groups
657532|NCT01149057|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657533|NCT01149148|B3|Baseline|Total|Total of all reporting groups
657500|NCT01148979|B2|Baseline|Vyvanse, Then Placebo|"Participants first received Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.
Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.
Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
657501|NCT01148979|B1|Baseline|Placebo, Then Vyvanse|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate capsule each morning for 4 weeks.
Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.
Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
657502|NCT01148979|P2|Participant Flow|Vyvanse, Then Placebo|"Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.
Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.
Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
657503|NCT01148979|P1|Participant Flow|Placebo, Then Vyvanse|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d.
Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.
Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
657504|NCT01148979|O2|Outcome|Lisdexamfetamine Dimesylate (Vyvanse)|"Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.
Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.
Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
657505|NCT01148979|O1|Outcome|Placebo Adjunct|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d.
Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.
Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
657506|NCT01148979|E2|Reported Event|Adjunct Placebo|"Participants receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they receive Lisdexamfetamine Dimesylate capsule each morning for 4 weeks.
Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
657507|NCT01148979|E1|Reported Event|Adjunct Lisdexamfetamine (Vyvanse)|"Participants receive Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.
Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg."
657508|NCT01149057|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657509|NCT01149057|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilograms (mg/kg) intravenous (IV) infusion every 4 weeks for a period of 96 weeks.
657510|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657511|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657512|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657513|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657514|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657515|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657516|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657517|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657518|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657519|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657520|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657521|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657522|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657523|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657524|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657525|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657526|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657527|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657528|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657529|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657530|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
657534|NCT01149148|B2|Baseline|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
657535|NCT01149148|B1|Baseline|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
657536|NCT01149148|P2|Participant Flow|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
657537|NCT01149148|P1|Participant Flow|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
657538|NCT01149148|O2|Outcome|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
657539|NCT01149148|O1|Outcome|Intervention INVOS Cerebral Oximetry Monitoring|At the start of surgery two sensor pads will be placed on the patients forehead and attached to the INVOS Monitoring System. If the rSO2 values decrease >20% from baseline or decline below 50 the anesthesiologist will initiate an intervention: Increase mean arterial pressure, check head and cannula position, increase pump flow, increase systemic oxygenation, increase PaCo2 >45, increase anesthetic depth by increaseing volatile anesthetic or administering propoful boluses, consider PRBC transfusion for Hct<21%.
657540|NCT01149148|O2|Outcome|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
657541|NCT01149148|O1|Outcome|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
657542|NCT01149148|E2|Reported Event|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
657543|NCT01149148|E1|Reported Event|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
657544|NCT01149421|B4|Baseline|Total|Total of all reporting groups
657547|NCT01149421|B1|Baseline|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657548|NCT01149421|P3|Participant Flow|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657549|NCT01149421|P2|Participant Flow|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657550|NCT01149421|P1|Participant Flow|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657551|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657552|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657553|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657554|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657555|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657556|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657557|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657558|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657559|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657560|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657561|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657562|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657563|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657564|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657565|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657566|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657567|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657568|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657569|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657570|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657571|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657572|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657573|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657574|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657575|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657576|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657577|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657578|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657579|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657580|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657581|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657582|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657584|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657585|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657586|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657587|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657588|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657589|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657590|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657591|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657592|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657593|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657594|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657595|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657596|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657597|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657598|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
658014|NCT01144052|B2|Baseline|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
657599|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657600|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657601|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657602|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657603|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657604|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657605|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657606|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657607|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657608|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657609|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657610|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657611|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657612|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657613|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657614|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657615|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657616|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657617|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657618|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657619|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657620|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657621|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657622|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657623|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657624|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657625|NCT01149421|E3|Reported Event|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
657626|NCT01149421|E2|Reported Event|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657627|NCT01149421|E1|Reported Event|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
657628|NCT01149434|B3|Baseline|Total|Total of all reporting groups
657629|NCT01149434|B2|Baseline|Pharmacokinetic Arm-Phase II|"Patients going on the Pharmacodynamic study will receive JI-101 only.
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
657682|NCT01149486|B1|Baseline|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
657683|NCT01149486|P2|Participant Flow|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
657630|NCT01149434|B1|Baseline|Pharmacokinetic Arm - Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.
Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus."
657631|NCT01149434|P2|Participant Flow|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
657632|NCT01149434|P1|Participant Flow|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.
Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
657633|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
657654|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
658667|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
657634|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
657635|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
657636|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.
Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
657637|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.
Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
657638|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.
Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
657639|NCT01149434|O1|Outcome|Pharmacokinetic Arm|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.
Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
657640|NCT01149434|E2|Reported Event|Pharmacodynamic Arm|"Patients going on the Pharmacodynamic study will receive JI-101 only.
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
658236|NCT01152294|E2|Reported Event|Decision Aid|Group receiving the decision aid (DVD/booklet)
657641|NCT01149434|E1|Reported Event|Pharmacokinetic Arm|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.
Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
657642|NCT01149460|B3|Baseline|Total|Total of all reporting groups
657643|NCT01149460|B2|Baseline|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
657644|NCT01149460|B1|Baseline|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
657645|NCT01149460|P2|Participant Flow|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
657646|NCT01149460|P1|Participant Flow|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
657647|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
657648|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
657649|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
657650|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
657651|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
657652|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
657653|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
657655|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
657656|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
657657|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
657658|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
657659|NCT01149460|E2|Reported Event|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
657660|NCT01149460|E1|Reported Event|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
657661|NCT01149473|B3|Baseline|Total|Total of all reporting groups
657662|NCT01149473|B2|Baseline|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in the second period.
657663|NCT01149473|B1|Baseline|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
657664|NCT01149473|P2|Participant Flow|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in the second period.
657665|NCT01149473|P1|Participant Flow|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
657666|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657667|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
657668|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657669|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
657670|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657671|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
657672|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657673|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
657674|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657675|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
657676|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657677|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
657678|NCT01149473|E2|Reported Event|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657679|NCT01149473|E1|Reported Event|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
657680|NCT01149486|B3|Baseline|Total|Total of all reporting groups
657681|NCT01149486|B2|Baseline|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
657726|NCT01149538|E1|Reported Event|Choline Bitartrate|"Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
657684|NCT01149486|P1|Participant Flow|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
657685|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657686|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
657687|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657688|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
657689|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657690|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
657691|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657692|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
657693|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657694|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
657695|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657696|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
657697|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657698|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
657699|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657700|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
657701|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657702|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
657703|NCT01149486|E2|Reported Event|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
657704|NCT01149486|E1|Reported Event|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
657705|NCT01149512|B1|Baseline|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
657706|NCT01149512|P1|Participant Flow|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
657707|NCT01149512|O1|Outcome|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
657708|NCT01149512|O1|Outcome|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
657709|NCT01149512|E1|Reported Event|LAGB Patients in Weight Wise Program|All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
657710|NCT01149538|B3|Baseline|Total|Total of all reporting groups
657711|NCT01149538|B2|Baseline|Placebo|"Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
657712|NCT01149538|B1|Baseline|Choline Bitartrate|"Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
657713|NCT01149538|P2|Participant Flow|Placebo|"Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
657714|NCT01149538|P1|Participant Flow|Choline Bitartrate|"Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
657715|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
657716|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
657717|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
657718|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
657719|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
657720|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
657721|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
657722|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
657723|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
657724|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation
Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
657725|NCT01149538|E2|Reported Event|Placebo|"Placebo for choline bitartrate supplementation
Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
657728|NCT01143259|B2|Baseline|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
657729|NCT01143259|B1|Baseline|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
657730|NCT01143259|P2|Participant Flow|Alvimopan|Treatment Group : The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
657731|NCT01143259|P1|Participant Flow|300 mg Polyethylene|Control Group : The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
657732|NCT01143259|O2|Outcome|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
657733|NCT01143259|O1|Outcome|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
657759|NCT01143324|B1|Baseline|MAST™ Procedure|Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657734|NCT01143259|O2|Outcome|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
657735|NCT01143259|O1|Outcome|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
657736|NCT01143259|E2|Reported Event|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
657737|NCT01143259|E1|Reported Event|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
657738|NCT01143272|B3|Baseline|Total|Total of all reporting groups
657739|NCT01143272|B2|Baseline|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo"
657740|NCT01143272|B1|Baseline|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
657741|NCT01143272|P2|Participant Flow|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo"
657742|NCT01143272|P1|Participant Flow|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
657743|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo"
657744|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
657745|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo"
657746|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
657747|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo"
657748|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
657749|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo"
657750|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
657751|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo"
657812|NCT01143610|O2|Outcome|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
657752|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
657753|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo"
657754|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
657755|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo"
657756|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
657757|NCT01143272|E2|Reported Event|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo"
657758|NCT01143272|E1|Reported Event|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
657786|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
657760|NCT01143324|P1|Participant Flow|MAST™ Procedure|Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657761|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657762|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657763|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657764|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657765|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657766|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657767|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657768|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657769|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657770|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657771|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657772|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657773|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657774|NCT01143324|E1|Reported Event|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
657775|NCT01143337|B3|Baseline|Total|Total of all reporting groups
657776|NCT01143337|B2|Baseline|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
MP-435 400mg:
There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.
Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
657777|NCT01143337|B1|Baseline|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
657778|NCT01143337|P3|Participant Flow|MP-435 400mg BID|MP-435 400mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
657779|NCT01143337|P2|Participant Flow|MP-435 100mg BID|MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
657780|NCT01143337|P1|Participant Flow|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
657813|NCT01143610|O1|Outcome|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
657781|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
MP-435 400mg:
There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.
Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
657782|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
657783|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
MP-435 400mg:
There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.
Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
657784|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
657785|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
MP-435 400mg:
There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.
Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
658129|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
657787|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
MP-435 400mg:
There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.
Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
657788|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
657789|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
MP-435 400mg:
There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.
Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
657790|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
657791|NCT01143337|E2|Reported Event|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
MP-435 400mg:
There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.
Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
657792|NCT01143337|E1|Reported Event|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
657793|NCT01143402|B4|Baseline|Total|Total of all reporting groups
657794|NCT01143402|B3|Baseline|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
657795|NCT01143402|B2|Baseline|Arm II (Selumetinib)|Randomized to Selumetinib
657796|NCT01143402|B1|Baseline|Arm I (Temozolomide)|Randomized to Temozolomide
657797|NCT01143402|P3|Participant Flow|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
657798|NCT01143402|P2|Participant Flow|Arm II (Selumetinib)|Randomized to Selumetinib
657799|NCT01143402|P1|Participant Flow|Arm I (Temozolomide)|Randomized to Temozolomide
657800|NCT01143402|O2|Outcome|Arm II (Selumetinib)|Randomized to Selumetinib
657801|NCT01143402|O1|Outcome|Arm I (Temozolomide)|Randomized to Temozolomide
657802|NCT01143402|O2|Outcome|Arm II (Selumetinib)|Randomized to Selumetinib
657803|NCT01143402|O1|Outcome|Arm I (Temozolomide)|Randomized to Temozolomide
657804|NCT01143402|E3|Reported Event|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
657805|NCT01143402|E2|Reported Event|Arm II (Selumetinib)|Randomized to Selumetinib
657806|NCT01143402|E1|Reported Event|Arm I (Temozolomide)|Randomized to Temozolomide
657807|NCT01143610|B3|Baseline|Total|Total of all reporting groups
657808|NCT01143610|B2|Baseline|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
657809|NCT01143610|B1|Baseline|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
657810|NCT01143610|P2|Participant Flow|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
657811|NCT01143610|P1|Participant Flow|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
658237|NCT01152294|E1|Reported Event|Control|Group not receiving the decision aid (DVD and booklet)
657814|NCT01143610|O2|Outcome|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
657815|NCT01143610|O1|Outcome|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
657816|NCT01143610|E2|Reported Event|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
657817|NCT01143610|E1|Reported Event|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
657818|NCT01143636|B4|Baseline|Total|Total of all reporting groups
657819|NCT01143636|B3|Baseline|Active tDCS&Sham tDCS - Healthy Controls|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
657820|NCT01143636|B2|Baseline|Sham tDCS - Pelvic Pain|Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657821|NCT01143636|B1|Baseline|Active tDCS - Pelvic Pain|Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657936|NCT01143792|P3|Participant Flow|Case Management + HIV Prevention|Description of CM: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
657822|NCT01143636|P4|Participant Flow|Healthy Subjects: Sham tDCS/Active tDCS|Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
657823|NCT01143636|P3|Participant Flow|Healthy Controls: Active tDCS/Sham tDCS|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
657824|NCT01143636|P2|Participant Flow|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657825|NCT01143636|P1|Participant Flow|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657826|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657827|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657828|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657829|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657830|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657831|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657832|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657914|NCT01143727|B1|Baseline|Collagenase Santyl Ointment|"Santyl
Santyl : Applied once every 24-hr period sufficient to cover the wound."
658238|NCT01152307|B3|Baseline|Total|Total of all reporting groups
657833|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657834|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657835|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657836|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657837|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657838|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657839|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657840|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657841|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657842|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657843|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657844|NCT01143636|O2|Outcome|Healthy Subjects: Sham tDCS|Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
657845|NCT01143636|O1|Outcome|Healthy Controls: Active tDCS|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
657846|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
657847|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
657848|NCT01143636|E4|Reported Event|ACTIVE tDCS - Sham|"ACTIVE tDCS: Subjects will receive a single session of active tDCS. The anode electrode will be placed on the primary motor cortex.
Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
657849|NCT01143636|E3|Reported Event|SHAM tDCS - Healthy|"SHAM tDCS: Subjects will receive a single session of sham tDCS. The anode electrode will be placed on the primary motor cortex.
For sham-controlled tDCS subjects, the current will be applied only for 30 seconds.
Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
657915|NCT01143727|P2|Participant Flow|Control|"Tegaderm Hydrogel
Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
657850|NCT01143636|E2|Reported Event|ACTIVE tDCS - Pelvic Pain Patients|"ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side.
Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
657851|NCT01143636|E1|Reported Event|SHAM tDCS - Pelvic Pain Patients|"SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side.
For sham-controlled tDCS subjects, the current will be applied only for 30 seconds.
Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
657852|NCT01143649|B6|Baseline|Total|Total of all reporting groups
657853|NCT01143649|B5|Baseline|tACS Active&Sham - Healthy|active or sham 15Hz-tACS over of the primary motor cortex (M1) bilaterally.
657854|NCT01143649|B4|Baseline|Sham tDCS + CIMT - Healthy|Participants received sham tDCS (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.
657855|NCT01143649|B3|Baseline|tDCS Active + CIMT - Healthy|Participants received active (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.
657856|NCT01143649|B2|Baseline|Sham tDCS + CIMT - Stroke|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
657857|NCT01143649|B1|Baseline|tDCS + CIMT - Stroke|"Participants received active tDCS over the primary motor cortex (M1). We used the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).
Transcranial Stimulation: Subjects were stimulated at 1 mA for 40 minutes."
657858|NCT01143649|P6|Participant Flow|Healthy Participants - Sham tACS, Then Active|Subjects will receive 20 min of sham and then tACS over the primary motor cortex in a randomized order.
657859|NCT01143649|P5|Participant Flow|Healthy Participants - Active tACS, Then Sham|Subjects will receive 20 min of active then sham tACS over the primary motor cortex in a randomized order.
658174|NCT01149876|E4|Reported Event|Proprietary Topical Plus Iontophoresis|
657860|NCT01143649|P4|Participant Flow|Healthy Participants: Sham tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of sham tDCS."
657861|NCT01143649|P3|Participant Flow|Healthy Participants: Active tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of tDCS at 1mA."
657862|NCT01143649|P2|Participant Flow|Sham tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).
Sham stimulation consists of 30secondes of stimulation at the beginning of the 40minutes treatment."
657863|NCT01143649|P1|Participant Flow|tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).
Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
657864|NCT01143649|O2|Outcome|Healthy Participants - Sham tACS|Subjects will receive 20 min of sham tACS
657865|NCT01143649|O1|Outcome|Healthy Participants - Active tACS|Subjects will receive 20 min of active tACS
657866|NCT01143649|O2|Outcome|Healthy Participants: Sham tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of sham tDCS."
657867|NCT01143649|O1|Outcome|Healthy Participants: Active tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of tDCS at 1mA."
657868|NCT01143649|O2|Outcome|Sham tDCS + CIMT|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
657869|NCT01143649|O1|Outcome|tDCS + CIMT|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).
Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
657870|NCT01143649|E6|Reported Event|Sham tACS - Healthy|Subjects will undergo 20 minutes of sham tACS.
657871|NCT01143649|E5|Reported Event|Active tACS - Healthy|Subjects will undergo 20 minutes of active tACS.
657872|NCT01143649|E4|Reported Event|Sham tDCS + CIMT - Healthy|subjects will undergo 40 minutes of sham tDCS.
657873|NCT01143649|E3|Reported Event|Active tDCS + CIMT - Healthy|subjects will undergo 40 minutes of tDCS at 1mA.
657874|NCT01143649|E2|Reported Event|Sham tDCS + CIMT - Stroke|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
657875|NCT01143649|E1|Reported Event|tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).
Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
657876|NCT01143688|B1|Baseline|Overall Study|
657916|NCT01143727|P1|Participant Flow|Collagenase Santyl Ointment|"Santyl
Santyl : Applied once every 24-hr period sufficient to cover the wound."
657877|NCT01143688|P1|Participant Flow|All Study Participants|Each study participant was randomized to a specific random sequence of interventions for visits 1-4 (e.g. first inhaled bronchodilator, then inhaled placebo, then sham acupuncture, then no intervention administered 3-7 days apart, or first sham acupuncture, then inhaled bronchodilator, then no intervention, then inhaled placebo administered 3-7 days apart, or any other combination of these four interventions in any order). This process was repeated for visits 5-8 and again for visits 9-12.
657878|NCT01143688|O4|Outcome|No-intervention Control|"Subjects will be instructed that they will receive no interventions on this visit.
Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
657879|NCT01143688|O3|Outcome|Placebo Acupuncture|Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture.
657880|NCT01143688|O2|Outcome|Placebo Inhaler|Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
657881|NCT01143688|O1|Outcome|Albuterol Inhaler|"Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.
Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
657882|NCT01143688|O4|Outcome|No-intervention Control|"Subjects will be instructed that they will receive no interventions on this visit.
Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
657883|NCT01143688|O3|Outcome|Placebo Acupuncture|Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture.
657884|NCT01143688|O2|Outcome|Placebo Inhaler|Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
657885|NCT01143688|O1|Outcome|Albuterol Inhaler|"Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.
Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
657886|NCT01143688|E4|Reported Event|No-intervention Control|"Subjects will be instructed that they will receive no interventions on this visit.
Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
657887|NCT01143688|E3|Reported Event|Placebo Acupuncture|Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture.
657888|NCT01143688|E2|Reported Event|Placebo Inhaler|Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
657917|NCT01143727|O2|Outcome|Control|"Tegaderm Hydrogel
Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
657918|NCT01143727|O1|Outcome|Collagenase Santyl Ointment|"Santyl
Santyl : Applied once every 24-hr period sufficient to cover the wound."
657919|NCT01143727|O2|Outcome|Control|"Tegaderm Hydrogel
Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
657920|NCT01143727|O1|Outcome|Collagenase Santyl Ointment|"Santyl
Santyl : Applied once every 24-hr period sufficient to cover the wound."
657889|NCT01143688|E1|Reported Event|Albuterol Inhaler|"Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.
Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
657890|NCT01143701|B3|Baseline|Total|Total of all reporting groups
657891|NCT01143701|B2|Baseline|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
657892|NCT01143701|B1|Baseline|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.
ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
657893|NCT01143701|P2|Participant Flow|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
657894|NCT01143701|P1|Participant Flow|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.
ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics ADHD guidelines."
657895|NCT01143701|O2|Outcome|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
657896|NCT01143701|O1|Outcome|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.
ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
657897|NCT01143701|O2|Outcome|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
657937|NCT01143792|P2|Participant Flow|MET + HIV Prevention|Description of MET: Treatment included two 1-hour sessions in addition to two HIV prevention sessions.
657938|NCT01143792|P1|Participant Flow|CRA + HIV Prevention|Description of CRA: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
657898|NCT01143701|O1|Outcome|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.
ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
657899|NCT01143701|E2|Reported Event|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
657900|NCT01143701|E1|Reported Event|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.
ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
657901|NCT01143714|B3|Baseline|Total|Total of all reporting groups
657902|NCT01143714|B2|Baseline|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
657903|NCT01143714|B1|Baseline|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
657904|NCT01143714|P2|Participant Flow|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
657905|NCT01143714|P1|Participant Flow|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
657906|NCT01143714|O2|Outcome|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
657907|NCT01143714|O1|Outcome|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
657908|NCT01143714|O2|Outcome|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
657909|NCT01143714|O1|Outcome|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
657910|NCT01143714|E2|Reported Event|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
657911|NCT01143714|E1|Reported Event|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
657912|NCT01143727|B3|Baseline|Total|Total of all reporting groups
657913|NCT01143727|B2|Baseline|Control|"Tegaderm Hydrogel
Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
657921|NCT01143727|E2|Reported Event|Control|"Tegaderm Hydrogel
Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
657922|NCT01143727|E1|Reported Event|Collagenase Santyl Ointment|"Santyl
Santyl : Applied once every 24-hr period sufficient to cover the wound."
657923|NCT01143766|B3|Baseline|Total|Total of all reporting groups
657924|NCT01143766|B2|Baseline|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
657925|NCT01143766|B1|Baseline|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
657926|NCT01143766|P2|Participant Flow|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
657927|NCT01143766|P1|Participant Flow|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
657928|NCT01143766|O2|Outcome|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
657929|NCT01143766|O1|Outcome|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
657930|NCT01143766|E2|Reported Event|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
657931|NCT01143766|E1|Reported Event|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
657932|NCT01143792|B4|Baseline|Total|Total of all reporting groups
657933|NCT01143792|B3|Baseline|Case Management + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
657934|NCT01143792|B2|Baseline|MET + HIV Prevention|Treatment included two 1-hour MI sessions for a total of 4 sessions
657935|NCT01143792|B1|Baseline|CRA + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
657939|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
657940|NCT01143792|O2|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
657941|NCT01143792|O1|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
657942|NCT01143792|O3|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
657943|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
657944|NCT01143792|O1|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
657945|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657946|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657947|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657948|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657949|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657950|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657951|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657952|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657953|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657954|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657955|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657956|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
658239|NCT01152307|B2|Baseline|Control|Group not receiving the decision aid (DVD/booklet)
657957|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657958|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657959|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657960|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657961|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657962|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
657963|NCT01143792|O3|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
657964|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
657965|NCT01143792|O1|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
657966|NCT01143792|E3|Reported Event|Case Management + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
657967|NCT01143792|E2|Reported Event|MET + HIV Prevention|Treatment included two 1-hour MI sessions for a total of 4 sessions
657969|NCT01143818|B1|Baseline|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
657970|NCT01143818|P1|Participant Flow|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
657971|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
657972|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
657973|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
657974|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
657975|NCT01143818|E1|Reported Event|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
657976|NCT01143883|B3|Baseline|Total|Total of all reporting groups
657977|NCT01143883|B2|Baseline|Standard of Care Dressing|55
657978|NCT01143883|B1|Baseline|Silverlon Dressing|55
657979|NCT01143883|P2|Participant Flow|Standard of Care Dressing|The standard plain gauze is used to dress the wound postoperatively
657980|NCT01143883|P1|Participant Flow|Silverlon Dressing|The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.
657981|NCT01143883|O2|Outcome|Standard of Care Dressing|55
657982|NCT01143883|O1|Outcome|Silverlon Dressing|55
657983|NCT01143883|E2|Reported Event|Standard of Care Dressing|55
657984|NCT01143883|E1|Reported Event|Silverlon Dressing|55
657985|NCT01143896|B3|Baseline|Total|Total of all reporting groups
657986|NCT01143896|B2|Baseline|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
657987|NCT01143896|B1|Baseline|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
657988|NCT01143896|P2|Participant Flow|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
658027|NCT01144052|O1|Outcome|Natalizumab|"Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
Natalizumab: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions."
657989|NCT01143896|P1|Participant Flow|Arm 1: Depression Collaborative Care|Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
657990|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
657991|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
657992|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
658015|NCT01144052|B1|Baseline|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
658016|NCT01144052|P2|Participant Flow|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
658017|NCT01144052|P1|Participant Flow|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
657993|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
657994|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
657995|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
657996|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
657997|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
657998|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
658028|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
658029|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
658030|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
658117|NCT01149772|E2|Reported Event|Enhanced Usual Care|Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
657999|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
658000|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
658001|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
658002|NCT01143896|E2|Reported Event|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
658003|NCT01143896|E1|Reported Event|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
658004|NCT01144026|B3|Baseline|Total|Total of all reporting groups
658005|NCT01144026|B2|Baseline|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
658006|NCT01144026|B1|Baseline|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
658007|NCT01144026|P2|Participant Flow|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
658008|NCT01144026|P1|Participant Flow|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
658009|NCT01144026|O2|Outcome|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
658019|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
658020|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
658021|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
658022|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
658023|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
658024|NCT01144052|O2|Outcome|Interferon-beta-1b|"250 mcg (8 MIU) subcutaneous injections every other day
interferon beta-1b: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 month at study entry. After a wash-out period of one month, interferon-beta-1b will be administered subcutaneously every other day as indicated by the manufacturers' instructions including the stepwise up-titration scheme as recommended for treatment start. The final dose of interferon beta-1b is 250 mcg (8 million International Units [MIU])"
658025|NCT01144052|O1|Outcome|Natalizumab|"Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
Natalizumab: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions."
658026|NCT01144052|O2|Outcome|Interferon-beta-1b|"250 mcg (8 MIU) subcutaneous injections every other day
interferon beta-1b: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 month at study entry. After a wash-out period of one month, interferon-beta-1b will be administered subcutaneously every other day as indicated by the manufacturers' instructions including the stepwise up-titration scheme as recommended for treatment start. The final dose of interferon beta-1b is 250 mcg (8 million International Units [MIU])"
658031|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
658032|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
658033|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
658034|NCT01144052|E2|Reported Event|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
658035|NCT01144052|E1|Reported Event|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
658036|NCT01149616|B3|Baseline|Total|Total of all reporting groups
658037|NCT01149616|B2|Baseline|Placebo|"placebo
placebo: placebo administered IV x1"
658038|NCT01149616|B1|Baseline|Intervention|"Dexamethasone 8mg iv x 1
Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
658039|NCT01149616|P2|Participant Flow|Placebo|"placebo
placebo: placebo administered IV x1"
658040|NCT01149616|P1|Participant Flow|Intervention|"Dexamethasone 8mg iv x 1
Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
658041|NCT01149616|O2|Outcome|Placebo|placebo: 2 ml normal saline IV x1
658042|NCT01149616|O1|Outcome|Intervention|Dexamethasone 8mg iv x 1
658043|NCT01149616|O2|Outcome|Placebo|placebo: 2 ml normal saline IV x1
658044|NCT01149616|O1|Outcome|Intervention|Dexamethasone 8mg iv x 1
658045|NCT01149616|O2|Outcome|Placebo|"placebo
placebo: placebo administered IV x1"
658046|NCT01149616|O1|Outcome|Intervention|"Dexamethasone 8mg iv x 1
Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
658047|NCT01149616|E2|Reported Event|Placebo|"placebo
placebo: placebo administered 2 ml normal saline IV x1"
658048|NCT01149616|E1|Reported Event|Intervention|"Dexamethasone 8mg iv x 1
Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1"
658049|NCT01149655|B3|Baseline|Total|Total of all reporting groups
658050|NCT01149655|B2|Baseline|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658051|NCT01149655|B1|Baseline|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658052|NCT01149655|P4|Participant Flow|Aripiprazole-Placebo-DB Maintenance|Participants who met stability criteria in period 2 (stabilization phase) received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
658053|NCT01149655|P3|Participant Flow|Aripiprazole-Double Blind (DB) Maintenance|Participants who met stability criteria in period 2 (stabilization phase) received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
658054|NCT01149655|P2|Participant Flow|Aripiprazole-Stabilization Phase|Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
658055|NCT01149655|P1|Participant Flow|Aripiprazole-Conversion Phase|Participants who had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
658056|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658057|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658058|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658059|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658060|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658061|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658062|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658063|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658064|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658065|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658066|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658067|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658068|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658231|NCT01152294|B1|Baseline|Control|Group not receiving the decision aid (DVD and booklet)
658069|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658070|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658071|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658072|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658073|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658074|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658075|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658076|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
658077|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
658078|NCT01149655|E4|Reported Event|Placebo-Double Blind Maintenance Treatment|Participants who met stability criteria in period 2 (stabilization phase) had received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
658079|NCT01149655|E3|Reported Event|Aripiprazole-Double Blind Maintenance Treatment|Participants who met stability criteria in period 2 (stabilization phase) had received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
658175|NCT01149876|E3|Reported Event|Tretinoin|
658176|NCT01149876|E2|Reported Event|Placebo|
658080|NCT01149655|E2|Reported Event|Arpiprazole-Stabilization Phase|Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
658081|NCT01149655|E1|Reported Event|Aripiprazole-Conversion Phase|Participants had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
658082|NCT01149733|B3|Baseline|Total|Total of all reporting groups
658083|NCT01149733|B2|Baseline|Flomax®|0.4 mg Capsule
658084|NCT01149733|B1|Baseline|Tamsulosin|0.4 mg Capsule
658085|NCT01149733|P2|Participant Flow|Flomax®|0.4 mg Capsule
658086|NCT01149733|P1|Participant Flow|Tamsulosin|0.4 mg Capsule
658087|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
658088|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
658089|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
658090|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
658091|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
658092|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
658093|NCT01149733|E2|Reported Event|Flomax®|0.4 mg Capsule
658094|NCT01149733|E1|Reported Event|Tamsulosin|0.4 mg Capsule
658095|NCT01149759|B1|Baseline|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.
Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
658096|NCT01149759|P1|Participant Flow|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.
Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
658097|NCT01149759|O1|Outcome|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.
Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
658098|NCT01149759|O1|Outcome|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.
Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
658099|NCT01149759|E1|Reported Event|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.
Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
658100|NCT01149772|B3|Baseline|Total|Total of all reporting groups
658101|NCT01149772|B2|Baseline|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
658102|NCT01149772|B1|Baseline|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. After completion of the active treatment sessions, the participant will receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made. Each active treatment session lasts 30 - 40 minutes and the booster calls last 10 - 15 minute.
658103|NCT01149772|P2|Participant Flow|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
658104|NCT01149772|P1|Participant Flow|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
658105|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
658106|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
658107|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
658108|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
658177|NCT01149876|E1|Reported Event|Proprietary Topical|
658668|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658109|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
658110|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
658111|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
658112|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
658113|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
658114|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
658115|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
658116|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
658232|NCT01152294|P2|Participant Flow|Decision Aid|Group receiving the decision aid (DVD/booklet)
658118|NCT01149772|E1|Reported Event|ACCESS|ACCESS: Participants received 6 treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completing core modules the participant was able to choose elective modules from Managing Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Relaxation. Participants were required to complete the first session in person and subsequent sessions participants had the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
658119|NCT01149785|B1|Baseline|Entire Study Population|Includes participants randomized to receive Crizotinib 150 mg IRT first and then Crizotinib 150 mg + Ketoconazole 200 mg BID
658120|NCT01149785|P2|Participant Flow|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet twice daily (BID), orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period. A washout period of at least 14 days was maintained between each period.
658121|NCT01149785|P1|Participant Flow|Crizotinib 150 mg|Single oral dose of crizotinib 150 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
658122|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658123|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658124|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658125|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658126|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658127|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658128|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658130|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658131|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658132|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658133|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658134|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658135|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658136|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658137|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658138|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658139|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658140|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658141|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658142|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658143|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658144|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658145|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658146|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658147|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658148|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658149|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658233|NCT01152294|P1|Participant Flow|Control|Group not receiving the decision aid (DVD and booklet)
658269|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
658150|NCT01149785|E2|Reported Event|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
658151|NCT01149785|E1|Reported Event|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
658152|NCT01149863|B1|Baseline|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).
Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
658153|NCT01149863|P1|Participant Flow|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).
Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
658154|NCT01149863|O1|Outcome|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).
Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
658155|NCT01149863|O1|Outcome|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).
Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
658156|NCT01149863|E1|Reported Event|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).
Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
658157|NCT01149876|B5|Baseline|Total|Total of all reporting groups
658158|NCT01149876|B4|Baseline|Proprietary Topical Plus Iontophoresis|
658159|NCT01149876|B3|Baseline|Tretinoin|
658160|NCT01149876|B2|Baseline|Placebo|
658161|NCT01149876|B1|Baseline|Proprietary Topical|
658162|NCT01149876|P4|Participant Flow|Nu Skin Product With Galvanic Spa System|
658163|NCT01149876|P3|Participant Flow|Tretinoin Cream 0.05|
658164|NCT01149876|P2|Participant Flow|Over the Counter Moisturizer|CeraVe Moisturizer
658165|NCT01149876|P1|Participant Flow|Nu Skin Product|
658166|NCT01149876|O4|Outcome|Nu Skin Product With Galvanic Spa System|
658167|NCT01149876|O3|Outcome|Tretinoin Cream 0.05|
658168|NCT01149876|O2|Outcome|Over the Counter Moisturizer|
658169|NCT01149876|O1|Outcome|Nu Skin Product|
658170|NCT01149876|O4|Outcome|Nu Skin Product With Galvanic Spa System|
658171|NCT01149876|O3|Outcome|Tretinoin Cream 0.05|
658172|NCT01149876|O2|Outcome|Over the Counter Moisturizer|CeraVe cream
658173|NCT01149876|O1|Outcome|Nu Skin Product|
658178|NCT01151761|B1|Baseline|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
658179|NCT01151761|P1|Participant Flow|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
658180|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
658181|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
658182|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
658183|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
658184|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
658185|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
658186|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
658187|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
658188|NCT01151761|E1|Reported Event|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
658189|NCT01151852|B3|Baseline|Total|Total of all reporting groups
658190|NCT01151852|B2|Baseline|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
658191|NCT01151852|B1|Baseline|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
658192|NCT01151852|P2|Participant Flow|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
658193|NCT01151852|P1|Participant Flow|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
658194|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
658195|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
658234|NCT01152294|O2|Outcome|Decision Aid|Group receiving the decision aid (DVD/booklet)
658196|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
658197|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
658198|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
658199|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
658200|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
658201|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
658202|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
658203|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
658204|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
658205|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
658206|NCT01151852|E2|Reported Event|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
658292|NCT01152385|O1|Outcome|Arm 1 - High Dose|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
658293|NCT01152385|O4|Outcome|Arm 4 - Placebo Dose|Placebo
658207|NCT01151852|E1|Reported Event|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
658208|NCT01151904|B1|Baseline|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
658209|NCT01151904|P1|Participant Flow|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
658210|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
658211|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
658212|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
658213|NCT01151904|E1|Reported Event|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
658214|NCT01152190|B3|Baseline|Total|Total of all reporting groups
658215|NCT01152190|B2|Baseline|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
658216|NCT01152190|B1|Baseline|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
658217|NCT01152190|P2|Participant Flow|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
658218|NCT01152190|P1|Participant Flow|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
658219|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
658220|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
658221|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
658222|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
658223|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
658224|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
658225|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
658226|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
658227|NCT01152190|E2|Reported Event|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
658228|NCT01152190|E1|Reported Event|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
658229|NCT01152294|B3|Baseline|Total|Total of all reporting groups
658230|NCT01152294|B2|Baseline|Decision Aid|Group receiving the decision aid (DVD/booklet)
658240|NCT01152307|B1|Baseline|Decision Aid|Group receiving the decision aid (DVD/booklet)
658241|NCT01152307|P2|Participant Flow|Control|Group not receiving the decision aid (DVD/booklet)
658242|NCT01152307|P1|Participant Flow|Decision Aid|Group receiving the decision aid (DVD/booklet)
658243|NCT01152307|O2|Outcome|Control|Group not receiving the decision aid (DVD/booklet)
658244|NCT01152307|O1|Outcome|Decision Aid|Group receiving the decision aid (DVD/booklet)
658245|NCT01152307|E2|Reported Event|Control|Group not receiving the decision aid (DVD/booklet)
658246|NCT01152307|E1|Reported Event|Decision Aid|Group receiving the decision aid (DVD/booklet)
658247|NCT01152359|B3|Baseline|Total|Total of all reporting groups
658248|NCT01152359|B2|Baseline|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
658249|NCT01152359|B1|Baseline|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
658294|NCT01152385|O3|Outcome|Arm 3 - Low Dose|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
658295|NCT01152385|O2|Outcome|Arm 2 - Middle Dose|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
658250|NCT01152359|P2|Participant Flow|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
658251|NCT01152359|P1|Participant Flow|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
658252|NCT01152359|O2|Outcome|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
658253|NCT01152359|O1|Outcome|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
658254|NCT01152359|E2|Reported Event|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
658255|NCT01152359|E1|Reported Event|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
658256|NCT01152385|B5|Baseline|Total|Total of all reporting groups
658257|NCT01152385|B4|Baseline|Placebo|Placebo
658258|NCT01152385|B3|Baseline|Low Dose|80 mg (daily dose)
658259|NCT01152385|B2|Baseline|Middle Dose|140 mg (daily dose)
658260|NCT01152385|B1|Baseline|High Dose|200 mg (daily dose)
658261|NCT01152385|P4|Participant Flow|Placebo|Placebo
658262|NCT01152385|P3|Participant Flow|Low Dose|80 mg (daily dose)
658263|NCT01152385|P2|Participant Flow|Middle Dose|140 mg (daily dose)
658264|NCT01152385|P1|Participant Flow|High Dose|200 mg (daily dose)
658265|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
658266|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
658267|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
658268|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
658270|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
658271|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
658272|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
658273|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
658274|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
658275|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
658276|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
658277|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
658278|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
658279|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
658280|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
658281|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
658282|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
658283|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
658284|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
658285|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
658286|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
658287|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
658288|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
658289|NCT01152385|O4|Outcome|Arm 4 - Placebo Dose|Placebo
658290|NCT01152385|O3|Outcome|Arm 3 - Low Dose|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
658291|NCT01152385|O2|Outcome|Arm 2 - Middle Dose|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
658302|NCT01152437|B3|Baseline|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658303|NCT01152437|B2|Baseline|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
658304|NCT01152437|B1|Baseline|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658305|NCT01152437|P3|Participant Flow|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658306|NCT01152437|P2|Participant Flow|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
658307|NCT01152437|P1|Participant Flow|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658308|NCT01152437|O2|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658309|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658310|NCT01152437|O3|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658311|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
658312|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658313|NCT01152437|O3|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658314|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
658315|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658316|NCT01152437|O1|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658317|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
658318|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658319|NCT01152437|E3|Reported Event|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658320|NCT01152437|E2|Reported Event|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
658321|NCT01152437|E1|Reported Event|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
658322|NCT01152450|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
658323|NCT01152450|P6|Participant Flow|Placebo/Tio R5 qd/Tio R2.5 Bid|Patients treated with a matching Placebo in period 1 (morning and evening), with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 2 and with Tiotropium 2.5 mcg in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
658324|NCT01152450|P5|Participant Flow|Placebo/Tio R2.5 Bid/Tio R5 qd|Patients treated with matching Placebo in period 1 (morning and evening), with Tiotropium 2.5 mcg in period 2 (morning and evening) and with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 3. All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
658325|NCT01152450|P4|Participant Flow|Tio R5 qd/Placebo/Tio R2.5 Bid|Patients treated with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 1, with matching Placebo in period 2 (morning and evening) and with Tiotropium 2.5 mcg in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
658326|NCT01152450|P3|Participant Flow|Tio R5 qd/Tio R2.5 Bid/Placebo|Patients treated with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 1, with Tiotropium 2.5 mcg in period 2 (morning and evening) and with matching Placebo in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
658365|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658669|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658327|NCT01152450|P2|Participant Flow|Tio R2.5 Bid/Placebo/Tio R5 qd|Patients treated with Tiotropium 2.5 mcg in period 1 (morning and evening), with a matching Placebo in period 2 (morning and evening) and with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 3. All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
658328|NCT01152450|P1|Participant Flow|Tio R2.5 Twice Daily (Bid) /Tio R5 Once Daily (qd) /Placebo|Patients treated with Tiotropium 2.5 mcg in period 1 (morning and evening), with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 2 and with a matching Placebo in period 3 (morning and evening). All products were delivered by the Respimat inhaler, on top on maintenance therapy with inhaled corticosteroid (iCS). No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
658329|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658330|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658331|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658332|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658333|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658334|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658335|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658336|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658337|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658338|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658339|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658340|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658341|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658342|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658343|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658344|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658345|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658346|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658347|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658348|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658349|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658350|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658474|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
658351|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658352|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658353|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658354|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658355|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658356|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658357|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658358|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658359|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658360|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658361|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658362|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658363|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658364|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658366|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658367|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658368|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658369|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658370|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658371|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658372|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658373|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658374|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658375|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658376|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658377|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658378|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658379|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658380|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658381|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658382|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658383|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658384|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658385|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658386|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658387|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658388|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658389|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658390|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658391|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658392|NCT01152450|E3|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658475|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
658393|NCT01152450|E2|Reported Event|Tio R2.5|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658394|NCT01152450|E1|Reported Event|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
658395|NCT01152554|B3|Baseline|Total|Total of all reporting groups
658396|NCT01152554|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658397|NCT01152554|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658398|NCT01152554|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658399|NCT01152554|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658400|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658401|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658402|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658403|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658404|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658405|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658406|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658407|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658664|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658408|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658409|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658410|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658411|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658412|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658413|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658414|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658415|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658416|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658417|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658418|NCT01152554|E2|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
658419|NCT01152554|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
658420|NCT01152580|B3|Baseline|Total|Total of all reporting groups
658421|NCT01152580|B2|Baseline|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
658422|NCT01152580|B1|Baseline|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
658423|NCT01152580|P2|Participant Flow|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
658424|NCT01152580|P1|Participant Flow|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
658425|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
658426|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
658427|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
658428|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
658429|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
658430|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
658431|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
658432|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
658433|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
658434|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
658435|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
658436|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
658437|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
658438|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
658439|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
658440|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
658441|NCT01152580|E2|Reported Event|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
658442|NCT01152580|E1|Reported Event|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
658443|NCT01152697|B1|Baseline|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658444|NCT01152697|P1|Participant Flow|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE). Dosage form was a long acting injectable administered every three to five weeks. Mean endpoint dose was 68.0 mg.
658445|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658446|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658447|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658448|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658449|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658450|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658451|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658452|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658453|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658454|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658455|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658456|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658457|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658458|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658459|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658460|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658461|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658462|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658463|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658464|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658465|NCT01152697|E1|Reported Event|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
658466|NCT01152788|B3|Baseline|Total|Total of all reporting groups
658467|NCT01152788|B2|Baseline|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
658468|NCT01152788|B1|Baseline|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
658469|NCT01152788|P2|Participant Flow|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
658470|NCT01152788|P1|Participant Flow|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
658471|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
658472|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
658473|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
658476|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
658477|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
658478|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
658479|NCT01152788|E2|Reported Event|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
658480|NCT01152788|E1|Reported Event|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
658481|NCT01152814|B1|Baseline|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
658482|NCT01152814|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
658483|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
658484|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
658485|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
658486|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
658487|NCT01152814|E1|Reported Event|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
658488|NCT01152996|B1|Baseline|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658489|NCT01152996|P1|Participant Flow|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658490|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658491|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658492|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658493|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658494|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658495|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658496|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658497|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658498|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658499|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658500|NCT01152996|E1|Reported Event|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
658501|NCT01153009|B5|Baseline|Total|Total of all reporting groups
658502|NCT01153009|B4|Baseline|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
658503|NCT01153009|B3|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658504|NCT01153009|B2|Baseline|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658505|NCT01153009|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
658506|NCT01153009|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
658507|NCT01153009|P3|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658508|NCT01153009|P2|Participant Flow|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658509|NCT01153009|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
658510|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
658511|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658512|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658513|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
658514|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
658515|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658516|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658517|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
658518|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
658665|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658519|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658520|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658521|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
658522|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
658523|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658524|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658525|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
658526|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
658527|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658528|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658529|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
658530|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
658531|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658532|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658533|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
658534|NCT01153009|E4|Reported Event|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
658535|NCT01153009|E3|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658536|NCT01153009|E2|Reported Event|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
658537|NCT01153009|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
658538|NCT01153269|B1|Baseline|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658539|NCT01153269|P1|Participant Flow|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658540|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
658541|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658637|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658542|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658543|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658544|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658545|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658546|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658547|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658548|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658549|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658550|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658551|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658552|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
658553|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658554|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658555|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658556|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
658557|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
658558|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658559|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658560|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
658561|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658562|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658563|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
658564|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658565|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658566|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658567|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
658568|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658569|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658570|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658571|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658572|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658573|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658574|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658575|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658576|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658577|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658578|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658579|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658580|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658638|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658581|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658582|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658583|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658584|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658585|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658586|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658587|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658588|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658589|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658590|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658591|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658592|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658593|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658594|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658595|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
658596|NCT01153269|E1|Reported Event|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
658597|NCT01153321|B3|Baseline|Total|Total of all reporting groups
658598|NCT01153321|B2|Baseline|Placebo|Placebo to match AZD2423 tablets, once daily
658599|NCT01153321|B1|Baseline|AZD2423|Two 50 mg AZD2423 tablets, once daily
658600|NCT01153321|P2|Participant Flow|Placebo|Placebo to match AZD2423 tablets, once daily
658601|NCT01153321|P1|Participant Flow|AZD2423|Two 50 mg AZD2423 tablets, once daily
658602|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658603|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658604|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658605|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658606|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658607|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658608|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658609|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658610|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658611|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658612|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658613|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658614|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658615|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658616|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658617|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658618|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658619|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658620|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658621|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658622|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658623|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658624|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658625|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658626|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658627|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658628|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658629|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658630|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658631|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658632|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658633|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658634|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658635|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658636|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658639|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658640|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658641|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658642|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658643|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658644|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658645|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658646|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658647|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658648|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658649|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658650|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658651|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658652|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658653|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658654|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658655|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658656|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658657|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658658|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658659|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658660|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658661|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658662|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658663|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658670|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658671|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658672|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658673|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658674|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658675|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658676|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658677|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658678|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658679|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658680|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658681|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658682|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658683|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658684|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658685|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658686|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658687|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658688|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658689|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658690|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658691|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658692|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658693|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658694|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658695|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658696|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658697|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658698|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658699|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658700|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658701|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658702|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658703|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658704|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658705|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658706|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658707|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658708|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
658709|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
658710|NCT01153321|E2|Reported Event|Placebo|Placebo to match AZD2423 tablets, once daily
658711|NCT01153321|E1|Reported Event|AZD2423 100 mg|
658712|NCT01153347|B5|Baseline|Total|Total of all reporting groups
658713|NCT01153347|B4|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658714|NCT01153347|B3|Baseline|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658715|NCT01153347|B2|Baseline|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658716|NCT01153347|B1|Baseline|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658717|NCT01153347|P4|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658718|NCT01153347|P3|Participant Flow|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658719|NCT01153347|P2|Participant Flow|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658720|NCT01153347|P1|Participant Flow|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658721|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658722|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658723|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658724|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658725|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658726|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658727|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658728|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658729|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658730|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658731|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658732|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658733|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658734|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658735|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658736|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658737|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658738|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658739|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658740|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658741|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658742|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658743|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658744|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658745|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658746|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658747|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658748|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658749|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658750|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658751|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658752|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658753|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658754|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658755|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658756|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658757|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658758|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658759|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658760|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658761|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658762|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658763|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658764|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658765|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658766|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658767|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658768|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658769|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658770|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658771|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658772|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658773|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658774|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658775|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658776|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658777|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658778|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658779|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658780|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658781|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658782|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658783|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658784|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658785|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658786|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658787|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658788|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658789|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658790|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658791|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658792|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658793|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658794|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658795|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658796|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658797|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658798|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658799|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658800|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658801|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658802|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658803|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658804|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658805|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658806|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658807|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658808|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658809|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
658810|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658811|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658812|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658813|NCT01153347|E4|Reported Event|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
658814|NCT01153347|E3|Reported Event|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
658815|NCT01153347|E2|Reported Event|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
658816|NCT01153347|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
658817|NCT01153425|B3|Baseline|Total|Total of all reporting groups
658818|NCT01153425|B2|Baseline|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0 and 24 months.
Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
658819|NCT01153425|B1|Baseline|Teriparatide (Forteo)|"20 µg of Teriparatide will be self-injected subcutaneously once a day for 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0 and 24 months.
Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
658820|NCT01153425|P2|Participant Flow|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0 and 24 months.
Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
658821|NCT01153425|P1|Participant Flow|Teriparatide (Forteo)|"20 µg of Teriparatide will be self-injected subcutaneously once a day for 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0 and 24 months.
Virtual Bone Biopsy by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power."
658842|NCT01153581|P1|Participant Flow|Women With and Without Orthostatic Intolerance|"Estrogen and Progesterone
17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills
17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
658843|NCT01153581|O2|Outcome|Women Without Orthostatic Tolerance|Women who pass out easily with gravitational challenge
658822|NCT01153425|O2|Outcome|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid administered intravenously at baseline and 12 months and MRI performed at 0, 12, and 24 months.
The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone’s “platelikeness”, erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.
No difference was detected between the two treatment arms."
658823|NCT01153425|O1|Outcome|Teriparatide (Forteo)|"20 µg of Teriparatide self-injected subcutaneously once a day for 24 months with MRI performed at 0 and 24 months.
The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone’s “platelikeness”, erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.
No difference was detected between the two treatment arms."
658824|NCT01153425|O2|Outcome|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid administered intravenously at baseline and 12 months and MRI performed at 0, 12, and 24 months.
The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone’s “platelikeness”, erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.
No difference was detected between the two treatment arms."
658825|NCT01153425|O1|Outcome|Teriparatide (Forteo)|"20 µg of Teriparatide self-injected subcutaneously once a day for 24 months with MRI performed at 0, 12 and 24 months.
The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone’s “platelikeness”, erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.
No difference was detected between the two treatment arms."
658860|NCT01153633|B3|Baseline|Total|Total of all reporting groups
658826|NCT01153425|E2|Reported Event|Zoledronic Acid (Reclast)|"5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0 and 24 months.
Virtual Bone Biopsy: MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques.
Zoledronic Acid: Participants are clinically indicated for treatment."
658827|NCT01153425|E1|Reported Event|Teriparatide (Forteo)|"20 µg of teriparatide will be self-injected subcutaneously once a day for 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0 and 24 months.
Virtual Bone Biopsy: MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques.
Teriparatide: Participants are clinically indicated for treatment."
658828|NCT01153503|B4|Baseline|Total|Total of all reporting groups
658829|NCT01153503|B3|Baseline|Ketorolac 30 mg IV|"Ketorolac 30 mg, IV at the end of surgery
First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
658830|NCT01153503|B2|Baseline|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine
First 24-h postoperative: IV-PCA morphine"
658831|NCT01153503|B1|Baseline|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery
First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
658832|NCT01153503|P3|Participant Flow|Ketorolac 30 mg|"Ketorolac 30 mg, IV at the end of surgery
First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
658833|NCT01153503|P2|Participant Flow|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery
First 24-h Postoperative: IV-PCA morphine
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
658834|NCT01153503|P1|Participant Flow|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP blocks and Ketorolac 30 mg IV at the end of the surgery
First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h and IV-PCA morphine
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
658835|NCT01153503|O3|Outcome|Ketorolac 30 mg|"Ketorolac 30 mg after surgery
First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
658836|NCT01153503|O2|Outcome|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine
First 24-h postoperative: IV-PCA morphine"
658837|NCT01153503|O1|Outcome|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery
First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
658838|NCT01153503|E3|Reported Event|Ketorolac 30 mg|"Ketorolac 30 mg after surgery
First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
658839|NCT01153503|E2|Reported Event|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine
First 24-h postoperative: IV-PCA morphine"
658840|NCT01153503|E1|Reported Event|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery
First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
658841|NCT01153581|B1|Baseline|Women|"Estrogen and Progesterone
17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills
17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
659055|NCT01153958|P1|Participant Flow|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
658844|NCT01153581|O1|Outcome|Women With Orthostatic Intolerance|"Estrogen and Progesterone
17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills
17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
658845|NCT01153581|O2|Outcome|High Orthostatic Tolerant|Women who can tolerate posture changes
658846|NCT01153581|O1|Outcome|Low Orthostatic Tolerance|Women who pass out easily in response to posture change
658847|NCT01153581|O1|Outcome|Women With and Without Orthostatic Intolerance|"Estrogen and Progesterone
17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills
17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
658848|NCT01153581|E3|Reported Event|Progesterone|The same women added progesterone (P4, 200 mg day−1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13–16.
658849|NCT01153581|E2|Reported Event|17β-Oestradiol|The same women added 17β-Oestradiol, E2; 0.2 mg day−1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16.
658850|NCT01153581|E1|Reported Event|Ganirelix Acetate|Ganirelix acetate (Organon, Roseland, NJ, USA), a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotrophin-releasing hormone (GnRH) to suppress GnRH. (250 μg in 0.5ml normal saline for 16 days).
658851|NCT01153620|B3|Baseline|Total|Total of all reporting groups
658852|NCT01153620|B2|Baseline|Lavasept 0.04%|
658853|NCT01153620|B1|Baseline|Ringer's Solution|
658854|NCT01153620|P2|Participant Flow|Lavasept 0.04%|
658855|NCT01153620|P1|Participant Flow|Ringer's Solution|
658856|NCT01153620|O2|Outcome|Ringer's Solution|Reduction in log 10 Colony Forming Units after 60 minutes of treatment
658857|NCT01153620|O1|Outcome|Lavasept 0.04%|Reduction in log 10 Colony Forming Units after 60 minutes of treatment
658858|NCT01153620|E2|Reported Event|Lavasept 0.04%|
658859|NCT01153620|E1|Reported Event|Ringer's Solution|
658861|NCT01153633|B2|Baseline|Normal Saline and Placebo Gel|Sodium Choride 0.9% Solution, Neutral Gel without Polihexanide, without Betaine
658862|NCT01153633|B1|Baseline|Prontosan Wound Solution and Gel|Polihexanide (0.1%), Betaine (0,1%), Purifed water
658863|NCT01153633|P2|Participant Flow|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
658864|NCT01153633|P1|Participant Flow|Prontosan Wound Solution and Gel|Polihexanide (0.1%), Betaine (0,1%), Purifed water
658865|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
658866|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
658867|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
658868|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
658869|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
658870|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
658871|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
658872|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
658873|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
658874|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
658875|NCT01153633|O2|Outcome|Normal Saline and Inactive Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
658876|NCT01153633|O1|Outcome|Prontosan Wound Irrigation Solution and Gel|Polihexanide 0.1%, Betaine 01.%, purified water, exipients
658877|NCT01153633|E2|Reported Event|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
658878|NCT01153633|E1|Reported Event|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
658879|NCT01153672|B1|Baseline|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
laboratory biomarker analysis: Correlative studies
biopsy: Optional correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
positron emission tomography: Correlative studies
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
gene expression analysis: Correlative studies"
658880|NCT01153672|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
laboratory biomarker analysis: Correlative studies
biopsy: Optional correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
positron emission tomography: Correlative studies
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
gene expression analysis: Correlative studies"
658881|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
laboratory biomarker analysis: Correlative studies
biopsy: Optional correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
positron emission tomography: Correlative studies
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
gene expression analysis: Correlative studies"
659056|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
658882|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
laboratory biomarker analysis: Correlative studies
biopsy: Optional correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
positron emission tomography: Correlative studies
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
gene expression analysis: Correlative studies"
658883|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
laboratory biomarker analysis: Correlative studies
biopsy: Optional correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
positron emission tomography: Correlative studies
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
gene expression analysis: Correlative studies"
658884|NCT01153672|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat: Given PO
laboratory biomarker analysis: Correlative studies
biopsy: Optional correlative studies
F-18 16 alpha-fluoroestradiol: Correlative studies
positron emission tomography: Correlative studies
anastrozole: Given PO
letrozole: Given PO
exemestane: Given PO
gene expression analysis: Correlative studies"
658885|NCT01153685|B3|Baseline|Total|Total of all reporting groups
658886|NCT01153685|B2|Baseline|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658887|NCT01153685|B1|Baseline|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658888|NCT01153685|P2|Participant Flow|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658889|NCT01153685|P1|Participant Flow|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658890|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658891|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658892|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658893|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658894|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658895|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658896|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658897|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658898|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658899|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658900|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658901|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658902|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658903|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658904|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658905|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658906|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658907|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658908|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658909|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
659057|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
658910|NCT01153685|E2|Reported Event|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658911|NCT01153685|E1|Reported Event|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
658912|NCT01153698|B1|Baseline|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658913|NCT01153698|P1|Participant Flow|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658914|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658915|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658916|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658917|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658918|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658919|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658920|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658921|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658922|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658923|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
658924|NCT01153698|E2|Reported Event|Pradaxa 220mg|All patients treated with Pradaxa
658925|NCT01153698|E1|Reported Event|Enoxaparin 40mg|All patients treated with enoxaparin
658926|NCT01153711|B1|Baseline|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days.
658927|NCT01153711|P1|Participant Flow|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days.
658928|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
658929|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658930|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
658931|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658932|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
658933|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658934|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
658935|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658936|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
658937|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658938|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
658939|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658940|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
658941|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658942|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
658943|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658944|NCT01153711|E2|Reported Event|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
658945|NCT01153711|E1|Reported Event|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658946|NCT01153724|B1|Baseline|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 35 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day).
659058|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
658947|NCT01153724|P1|Participant Flow|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 35 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day).
658948|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
658949|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658950|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
658951|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658952|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
658953|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658954|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
658955|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658956|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
658957|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658958|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
658959|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658960|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
658961|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658962|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
658963|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658964|NCT01153724|E2|Reported Event|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
658965|NCT01153724|E1|Reported Event|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
658966|NCT01153763|B1|Baseline|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658967|NCT01153763|P1|Participant Flow|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658968|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658969|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658970|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658971|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658972|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658973|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
659059|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
658974|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658975|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658976|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658977|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658978|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658979|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658980|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
659009|NCT01153841|B1|Baseline|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
658981|NCT01153763|E1|Reported Event|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 mg orally twice a day and continued on treatment until disease progression, death, or unacceptable AEs . Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
658982|NCT01153815|B3|Baseline|Total|Total of all reporting groups
658983|NCT01153815|B2|Baseline|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658984|NCT01153815|B1|Baseline|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658985|NCT01153815|P2|Participant Flow|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658986|NCT01153815|P1|Participant Flow|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658987|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658988|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658989|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658990|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658991|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658992|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658993|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658994|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658995|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658996|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
659060|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
658997|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658998|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
658999|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
659000|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
659001|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
659002|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
659003|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
659004|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
659005|NCT01153815|E2|Reported Event|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
659006|NCT01153815|E1|Reported Event|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
659007|NCT01153841|B3|Baseline|Total|Total of all reporting groups
659008|NCT01153841|B2|Baseline|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659144|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659010|NCT01153841|P2|Participant Flow|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659011|NCT01153841|P1|Participant Flow|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659012|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659013|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659014|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659015|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659016|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659017|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659018|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659019|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659020|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659021|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659022|NCT01153841|E2|Reported Event|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659023|NCT01153841|E1|Reported Event|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
659024|NCT01153893|B3|Baseline|Total|Total of all reporting groups
659061|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
659025|NCT01153893|B2|Baseline|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659026|NCT01153893|B1|Baseline|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659027|NCT01153893|P2|Participant Flow|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659028|NCT01153893|P1|Participant Flow|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659029|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659030|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659145|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659031|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659032|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659033|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659034|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659035|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659036|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659037|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659062|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
659063|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
659589|NCT01154816|O11|Outcome|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
659038|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659039|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659040|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659041|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659042|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659043|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659044|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659045|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659046|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659047|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659048|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659049|NCT01153893|E2|Reported Event|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659050|NCT01153893|E1|Reported Event|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
659051|NCT01153958|B3|Baseline|Total|Total of all reporting groups
659052|NCT01153958|B2|Baseline|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
659053|NCT01153958|B1|Baseline|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
659054|NCT01153958|P2|Participant Flow|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
659590|NCT01154816|O10|Outcome|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
659064|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
659065|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
659066|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
659067|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
659068|NCT01153958|E2|Reported Event|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
659069|NCT01153958|E1|Reported Event|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
659070|NCT01153971|B1|Baseline|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659079|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659071|NCT01153971|P1|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with complete response (CR), unconfirmed complete response (CRu), or partial response (PR), received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659072|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659073|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659074|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659075|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659100|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
659101|NCT01153984|E1|Reported Event|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
659102|NCT01154010|B3|Baseline|Total|Total of all reporting groups
659076|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659077|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659078|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659146|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659217|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659080|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659081|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659082|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659083|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659084|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659169|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659085|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659086|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659087|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659108|NCT01154010|O1|Outcome|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.
PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.
Analysis in process as of December, 2016."
659088|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659089|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659090|NCT01153971|E1|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times.
659091|NCT01153984|B1|Baseline|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
659092|NCT01153984|P1|Participant Flow|Erlotinib|Participants received 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
659093|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
659094|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
659095|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
659096|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
659097|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
659098|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
659099|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
659103|NCT01154010|B2|Baseline|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.
PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids."
659104|NCT01154010|B1|Baseline|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.
PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids."
659105|NCT01154010|P2|Participant Flow|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.
PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.
Analysis in process as of December, 2016."
659106|NCT01154010|P1|Participant Flow|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.
PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.
Analysis in process as of December, 2016."
659107|NCT01154010|O2|Outcome|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.
PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.
Analysis in process as of December, 2016."
659109|NCT01154010|E2|Reported Event|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.
PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.
Analysis on-going as of December, 2016."
659110|NCT01154010|E1|Reported Event|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.
PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.
Analysis on-going as of December, 2016."
659111|NCT01154036|B4|Baseline|Total|Total of all reporting groups
659112|NCT01154036|B3|Baseline|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks
659113|NCT01154036|B2|Baseline|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659114|NCT01154036|B1|Baseline|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659115|NCT01154036|P8|Participant Flow|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659116|NCT01154036|P7|Participant Flow|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659117|NCT01154036|P6|Participant Flow|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659118|NCT01154036|P5|Participant Flow|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659119|NCT01154036|P4|Participant Flow|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659120|NCT01154036|P3|Participant Flow|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659121|NCT01154036|P2|Participant Flow|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659122|NCT01154036|P1|Participant Flow|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659123|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659124|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659125|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659126|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659127|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659128|NCT01154036|O3|Outcome|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659129|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659130|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659131|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659591|NCT01154816|O9|Outcome|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
659132|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659133|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659134|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659135|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659136|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659137|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659138|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659139|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659140|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659141|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659142|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659143|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659147|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659148|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659149|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659150|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659151|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659152|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659153|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659154|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659155|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659156|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659157|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659158|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659159|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659160|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659161|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659162|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659163|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659164|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659165|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659166|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659167|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659168|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659170|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659171|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659172|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659173|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659174|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659175|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659176|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659177|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659178|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659179|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659180|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659216|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659181|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659182|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659183|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659184|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659185|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659186|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659187|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659188|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659189|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659190|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659191|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659192|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659193|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659194|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659195|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659196|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659197|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659198|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659199|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659200|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659201|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659202|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659203|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659273|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659204|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659205|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659206|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659207|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659208|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659209|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659210|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659211|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659212|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659213|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659214|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659215|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659218|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659219|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659220|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659221|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659222|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659223|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659224|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659225|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659226|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659227|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659228|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659229|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659230|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659231|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659232|NCT01154036|O3|Outcome|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
659233|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659234|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659235|NCT01154036|E8|Reported Event|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
659236|NCT01154036|E7|Reported Event|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659237|NCT01154036|E6|Reported Event|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
659238|NCT01154036|E5|Reported Event|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
659460|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659239|NCT01154036|E4|Reported Event|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
659240|NCT01154036|E3|Reported Event|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks
659241|NCT01154036|E2|Reported Event|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
659242|NCT01154036|E1|Reported Event|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
659243|NCT01147055|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 250 mg IRT first and then crizotinib 250 mg + rifampin 600 mg.
659244|NCT01147055|P2|Participant Flow|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in fasted state from Day 1 to Day 14. A single oral dose of crizotinib 250 mg IRTs was administered on Day 9 in second intervention period. A washout period of at least 14 days was maintained between each period.
659245|NCT01147055|P1|Participant Flow|Crizotinib 250 mg|Single oral dose of crizotinib 250 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
659246|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659247|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659248|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659249|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659250|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659251|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659614|NCT01154985|B2|Baseline|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
659252|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659253|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659254|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659255|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659256|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659257|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659258|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659259|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659260|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659261|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659262|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659263|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659264|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659265|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659266|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659267|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659268|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659269|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659270|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659271|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659272|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659274|NCT01147055|E2|Reported Event|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
659275|NCT01147055|E1|Reported Event|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
659276|NCT01147068|B8|Baseline|Total|Total of all reporting groups
659277|NCT01147068|B7|Baseline|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659278|NCT01147068|B6|Baseline|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659279|NCT01147068|B5|Baseline|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659280|NCT01147068|B4|Baseline|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659281|NCT01147068|B3|Baseline|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659282|NCT01147068|B2|Baseline|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659283|NCT01147068|B1|Baseline|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659309|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659284|NCT01147068|P7|Participant Flow|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659285|NCT01147068|P6|Participant Flow|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659286|NCT01147068|P5|Participant Flow|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659287|NCT01147068|P4|Participant Flow|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659288|NCT01147068|P3|Participant Flow|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659289|NCT01147068|P2|Participant Flow|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659290|NCT01147068|P1|Participant Flow|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659291|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659292|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659293|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659294|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659295|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659296|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659297|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659298|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659299|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659300|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659301|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659302|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659303|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659304|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659305|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659306|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659307|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659308|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659615|NCT01154985|B1|Baseline|Placebo|Placebo: Placebo three times a day (TID) for 365 days
659310|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659311|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659312|NCT01147068|E7|Reported Event|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659313|NCT01147068|E6|Reported Event|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659314|NCT01147068|E5|Reported Event|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659315|NCT01147068|E4|Reported Event|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659316|NCT01147068|E3|Reported Event|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659317|NCT01147068|E2|Reported Event|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659318|NCT01147068|E1|Reported Event|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart
0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
659319|NCT01154127|B3|Baseline|Total|Total of all reporting groups
659320|NCT01154127|B2|Baseline|Placebo Followed by NVA237|"Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days
Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659321|NCT01154127|B1|Baseline|NVA237 Followed by Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.
Period 2: Matching placebo via NEOHALER inhaler device for 21 days
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659322|NCT01154127|P2|Participant Flow|Placebo Followed by NVA237|"Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days
Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659323|NCT01154127|P1|Participant Flow|NVA237 Followed by Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.
Period 2: Matching placebo via NEOHALER inhaler device for 21 days
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659405|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659324|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659325|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659326|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659327|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659328|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659329|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659330|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659478|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659616|NCT01154985|P3|Participant Flow|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
659331|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659332|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659333|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659334|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659335|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659336|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659337|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659338|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659339|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659340|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659341|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659342|NCT01154127|E2|Reported Event|Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days
Period 2: Matching placebo via NEOHALER inhaler device for 21 days
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659343|NCT01154127|E1|Reported Event|NVA237|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days
Period 2: Matching placebo via NEOHALER inhaler device for 21 days
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study."
659344|NCT01154140|B3|Baseline|Total|Total of all reporting groups
659345|NCT01154140|B2|Baseline|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659346|NCT01154140|B1|Baseline|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659347|NCT01154140|P2|Participant Flow|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659348|NCT01154140|P1|Participant Flow|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659349|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659350|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659351|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659352|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659353|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659354|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659355|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659356|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659461|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659357|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659358|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659359|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659360|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659361|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659362|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659617|NCT01154985|P2|Participant Flow|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
659363|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659364|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659365|NCT01154140|O3|Outcome|Crizotinib (Cycle 5 Day 1)|Crizotinib capsules, 250 mg BID, were administered orally at Cycle 5 Day 1. Treatment cycle was defined as 3 weeks.
659366|NCT01154140|O2|Outcome|Crizotinib (Cycle 3 Day 1)|Crizotinib capsules, 250 mg BID, were administered orally at Cycle 3 Day 1. Treatment cycle was defined as 3 weeks.
659367|NCT01154140|O1|Outcome|Crizotinib (Cycle 2 Day 1)|Crizotinib capsules, 250 mg BID, were administered orally at Cycle 2 Day 1. Treatment cycle was defined as 3 weeks.
659368|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659369|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659370|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659371|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659406|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659462|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659372|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659373|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659374|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659375|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659376|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659377|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659378|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659379|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659380|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659381|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659382|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659383|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659384|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659385|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659592|NCT01154816|O8|Outcome|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
659386|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659387|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659388|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659389|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659390|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659391|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659392|NCT01154140|E2|Reported Event|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
659618|NCT01154985|P1|Participant Flow|Placebo|Placebo: Placebo three times a day (TID) for 365 days
659393|NCT01154140|E1|Reported Event|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
659394|NCT01154153|B3|Baseline|Total|Total of all reporting groups
659395|NCT01154153|B2|Baseline|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659396|NCT01154153|B1|Baseline|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659397|NCT01154153|P2|Participant Flow|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659398|NCT01154153|P1|Participant Flow|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659399|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659400|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659401|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659402|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659403|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659404|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659576|NCT01154816|P5|Participant Flow|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
659407|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659408|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659409|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659410|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659411|NCT01154153|E2|Reported Event|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659412|NCT01154153|E1|Reported Event|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
659413|NCT01154166|B3|Baseline|Total|Total of all reporting groups
659414|NCT01154166|B2|Baseline|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659415|NCT01154166|B1|Baseline|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659619|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
659416|NCT01154166|P2|Participant Flow|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659417|NCT01154166|P1|Participant Flow|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659418|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659419|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659420|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659458|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659459|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659577|NCT01154816|P4|Participant Flow|Recurrent Osteosarcoma|Experimental: Arm 4
659421|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659422|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659423|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659424|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659425|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659479|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659426|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659427|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659428|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659429|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659430|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659578|NCT01154816|P3|Participant Flow|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
659431|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659432|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659433|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659434|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659435|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659480|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659436|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659437|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659438|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659439|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659440|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659441|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659442|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659443|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659444|NCT01154166|E2|Reported Event|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
659445|NCT01154166|E1|Reported Event|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
659446|NCT01154218|B1|Baseline|Entire Study Population|Includes participants randomized to receive any treatment (crizotinib 250 mg IRT fasted first, crizotinib 250 mg PIC fasted first, crizotinib 250 mg CIC fasted first and crizotinib 250 mg CIC fed).
659447|NCT01154218|P4|Participant Flow|Crizotinib 250 mg CIC Fed, CIC Fasted, PIC Fasted, IRT Fasted|Single oral dose of crizotinib 250 mg CIC in fed state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg PIC in fasted state in third intervention period; and single oral dose of crizotinib 250 mg IRT in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
659448|NCT01154218|P3|Participant Flow|Crizotinib 250 mg CIC Fasted, IRT Fasted, CIC Fed, PIC Fasted|Single oral dose of crizotinib 250 mg CIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in third intervention period; and single oral dose of crizotinib 250 mg PIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
659449|NCT01154218|P2|Participant Flow|Crizotinib 250 mg PIC Fasted, CIC Fed, IRT Fasted, CIC Fasted|Single oral dose of crizotinib 250 mg PIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in second intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
659450|NCT01154218|P1|Participant Flow|Crizotinib 250 mg IRT Fasted, PIC Fasted, CIC Fasted, CIC Fed|Single oral dose of crizotinib 250 milligram (mg) immediate release tablet (IRT) in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg powder in capsule (PIC) in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg commercial image capsule (CIC) in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fed state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
659451|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659452|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659453|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659454|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659455|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659456|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659457|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659463|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659464|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659465|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659466|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659467|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659468|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659469|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659470|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659471|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659472|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659473|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659474|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659475|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659476|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659477|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659612|NCT01154985|B4|Baseline|Total|Total of all reporting groups
659481|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659482|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659483|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659484|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659485|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659486|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659487|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659488|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659489|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659490|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659491|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659492|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659493|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659494|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659495|NCT01154218|E4|Reported Event|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
659496|NCT01154218|E3|Reported Event|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
659497|NCT01154218|E2|Reported Event|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
659498|NCT01154218|E1|Reported Event|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
659499|NCT01154231|B1|Baseline|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
659500|NCT01154231|P1|Participant Flow|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
659501|NCT01154231|O1|Outcome|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
659579|NCT01154816|P2|Participant Flow|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
659593|NCT01154816|O7|Outcome|Childhood Hepatoblastoma|Experimental: Arm 7
659502|NCT01154231|O1|Outcome|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
659503|NCT01154231|O1|Outcome|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
659504|NCT01154231|E1|Reported Event|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
659505|NCT01154283|B3|Baseline|Total|Total of all reporting groups
659506|NCT01154283|B2|Baseline|IPAP-only, NIPPV Then Bi-level, Standard NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure then Standard NIPPV with both an inspiratory and expiratory positive airway pressure
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
659507|NCT01154283|B1|Baseline|Bi-level, Standard, NIPPV Then IPAP-only NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure then NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
659508|NCT01154283|P2|Participant Flow|IPAP-only, NIPPV Then Bi-level, Standard NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure then Standard NIPPV with both an inspiratory and expiratory positive airway pressure
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
659509|NCT01154283|P1|Participant Flow|Bi-level, Standard, NIPPV Then IPAP-only NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure then NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
659510|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
659511|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
659512|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
659513|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
659514|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
659515|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
659516|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
659517|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
659518|NCT01154283|E2|Reported Event|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure.
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
659519|NCT01154283|E1|Reported Event|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
659520|NCT01154296|B3|Baseline|Total|Total of all reporting groups
659521|NCT01154296|B2|Baseline|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
659522|NCT01154296|B1|Baseline|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.
RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
659523|NCT01154296|P2|Participant Flow|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
659580|NCT01154816|P1|Participant Flow|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
659581|NCT01154816|O1|Outcome|All Patients|All patients.
659582|NCT01154816|O1|Outcome|All Patients|All patients.
659583|NCT01154816|O1|Outcome|All Patients|All patients.
659584|NCT01154816|O1|Outcome|All Patients|All patients.
659524|NCT01154296|P1|Participant Flow|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.
RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
659525|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
659526|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.
RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
659527|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
659528|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.
RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
659529|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
659530|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.
RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
659531|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
659532|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.
RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
659533|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
659534|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.
RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
659535|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
659585|NCT01154816|O1|Outcome|All Patients|All patients.
659586|NCT01154816|O1|Outcome|All Patients|All patients.
659587|NCT01154816|O1|Outcome|All Patients|All patients
659536|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.
RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
659537|NCT01154296|E2|Reported Event|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
659538|NCT01154296|E1|Reported Event|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.
RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
659539|NCT01154322|B1|Baseline|Pediatric Mask|Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
659540|NCT01154322|P1|Participant Flow|Pediatric Mask|Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
659541|NCT01154322|O1|Outcome|Pixi Mask|AHI with Pixi mask
659542|NCT01154322|O1|Outcome|Currently-used Mask|Baseline AHI prior to Pixi mask use
659543|NCT01154322|E1|Reported Event|Overall Study|
659544|NCT01154335|B4|Baseline|Total|Total of all reporting groups
659545|NCT01154335|B3|Baseline|Dose Level 2a|"combination of OSI-906 and everolimus
OSI-906: 100 mg Twice a Day, cycle-28 days
Everolimus: 5mg Daily, cycle-28 days"
659546|NCT01154335|B2|Baseline|Dose Level 2|"combination of OSI-906 and everolimus
OSI-906: 100 mg Twice a Day, cycle-28 days
Everolimus: 10mg Daily, cycle-28 days"
659547|NCT01154335|B1|Baseline|Dose Level 1|"combination of OSI-906 and everolimus
OSI-906: 50 mg Twice a Day, cycle-28 days
Everolimus: 5mg Daily, cycle-28 days"
659548|NCT01154335|P3|Participant Flow|Dose Level 2a|"combination of OSI-906 and everolimus
OSI-906: 100 mg Twice a Day, cycle-28 days
Everolimus: 5mg Daily, cycle-28 days"
659613|NCT01154985|B3|Baseline|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
659549|NCT01154335|P2|Participant Flow|Dose Level 2|"combination of OSI-906 and everolimus
OSI-906: 100 mg Twice a Day, cycle-28 days
Everolimus: 10mg Daily, cycle-28 days"
659550|NCT01154335|P1|Participant Flow|Dose Level 1|"combination of OSI-906 and everolimus
OSI-906: 50 mg Twice a Day, cycle-28 days
Everolimus: 5mg Daily, cycle-28 days"
659551|NCT01154335|O1|Outcome|All Patients|Response Rate was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
659552|NCT01154335|O1|Outcome|All Patients|Overall Survival was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
659553|NCT01154335|O1|Outcome|All Patients|Progression-Free Survival was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
659554|NCT01154335|O1|Outcome|All Patients|Determination of the MTD consists of the selection of one of the three dose levels as the maximum tolerated dose. This outcome is the same for all patients.
659555|NCT01154335|E1|Reported Event|All Patients|Adverse Event data was was calculated for all patients at all dose levels
659556|NCT01154816|B13|Baseline|Total|Total of all reporting groups
659557|NCT01154816|B12|Baseline|Rhaboid Malignancy|Experimental: Arm 12
659558|NCT01154816|B11|Baseline|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
659559|NCT01154816|B10|Baseline|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
659560|NCT01154816|B9|Baseline|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
659561|NCT01154816|B8|Baseline|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
659562|NCT01154816|B7|Baseline|Childhood Hepatoblastoma|Experimental: Arm 7
659563|NCT01154816|B6|Baseline|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
659564|NCT01154816|B5|Baseline|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
659565|NCT01154816|B4|Baseline|Recurrent Osteosarcoma|Experimental: Arm 4
659566|NCT01154816|B3|Baseline|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
659567|NCT01154816|B2|Baseline|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
659568|NCT01154816|B1|Baseline|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
659569|NCT01154816|P12|Participant Flow|Rhaboid Malignancy|Experimental: Arm 12
659570|NCT01154816|P11|Participant Flow|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
659571|NCT01154816|P10|Participant Flow|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
659572|NCT01154816|P9|Participant Flow|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
659573|NCT01154816|P8|Participant Flow|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
659574|NCT01154816|P7|Participant Flow|Childhood Hepatoblastoma|Experimental: Arm 7
659575|NCT01154816|P6|Participant Flow|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
659588|NCT01154816|O12|Outcome|Rhaboid Malignancy|Experimental: Arm 12
659594|NCT01154816|O6|Outcome|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
659595|NCT01154816|O5|Outcome|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
659596|NCT01154816|O4|Outcome|Recurrent Osteosarcoma|Experimental: Arm 4
659597|NCT01154816|O3|Outcome|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
659598|NCT01154816|O2|Outcome|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
659599|NCT01154816|O1|Outcome|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
659600|NCT01154816|E12|Reported Event|Rhaboid Malignancy|Experimental: 12
659601|NCT01154816|E11|Reported Event|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
659602|NCT01154816|E10|Reported Event|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
659603|NCT01154816|E9|Reported Event|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
659604|NCT01154816|E8|Reported Event|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
659605|NCT01154816|E7|Reported Event|Childhood Hepatoblastoma|Experimental: Arm 7
659606|NCT01154816|E6|Reported Event|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
659607|NCT01154816|E5|Reported Event|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
659608|NCT01154816|E4|Reported Event|Recurrent Osteosarcoma|Experimental: Arm 4
659609|NCT01154816|E3|Reported Event|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
659610|NCT01154816|E2|Reported Event|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
659611|NCT01154816|E1|Reported Event|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
659620|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
659621|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
659622|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
659623|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
659624|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
659625|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
659626|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
659627|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
659628|NCT01154985|E3|Reported Event|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
659629|NCT01154985|E2|Reported Event|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
659630|NCT01154985|E1|Reported Event|Placebo|Placebo: Placebo three times a day (TID) for 365 days
659631|NCT01155011|B3|Baseline|Total|Total of all reporting groups
659632|NCT01155011|B2|Baseline|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
659633|NCT01155011|B1|Baseline|MIPARC Intervention|"Intervention participants engage in group education session, individual phone counseling calls and group walks for the first 6 months. The telephone counseling calls will be eliminated after 3 months.
Participants monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. They receive support from peer leaders. The peer leaders also receive advocacy training from a non-profit advocacy organization to conduct walk audits of their CCRC and help mobilize participants to make changes to their community that will increase or improve the opportunities for physical activity."
659634|NCT01155011|P2|Participant Flow|Health Education Control|The control group will receive an active health education intervention. The education curriculum will involve both lectures and mailed materials. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
659635|NCT01155011|P1|Participant Flow|MIPARC Intervention|"The intervention will focus on increasing light to moderate PA, primarily promoting walking by gradually increasing participants' daily step counts.
Participants will monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. Participants will attend group educational sessions and group walks, receive phone counseling calls from UCSD counselors, receive support from peer mentors, In order to increase the sustainability of the project, MIPARC will focus on addressing on-site policies and neighborhood factors that are barriers to physical activity."
659636|NCT01155011|O2|Outcome|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
659637|NCT01155011|O1|Outcome|MIPARC Intervention|"Intervention participants engage in group education session, individual phone counseling calls and group walks for the first 6 months. The telephone counseling calls will be eliminated after 3 months.
Participants monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. They receive support from peer leaders."
659638|NCT01155011|O2|Outcome|Health Education Control|The control group will receive an active health education intervention.. The lectures will be delivered to match the MIPARC intervention schedule.
659639|NCT01155011|O1|Outcome|MIPARC Intervention|Participants received group educations sessions, group walks, phone counseling, support from peer leaders.
659640|NCT01155011|O2|Outcome|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA.
659641|NCT01155011|O1|Outcome|MIPARC Intervention|Intervention participants received group education sessions, group walks, phone counseling and support from peer leaders.
659642|NCT01155011|E2|Reported Event|Health Education Control|The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA.
659643|NCT01155011|E1|Reported Event|MIPARC Intervention|Intervention participants received group education sessions, group walks, phone counseling and support from peer leaders.
659644|NCT01155024|B1|Baseline|Entire Study Population|Includes groups randomized to receive the traditional diagnostic prosthetic socket first and the direct manufactured prosthetic socket first
659645|NCT01155024|P2|Participant Flow|Direct Manufactured Socket|Initial fitting of a direct manufactured prosthetic socket
659646|NCT01155024|P1|Participant Flow|Traditional Socket|Initial fitting of a traditional diagnostic prosthetic socket
659647|NCT01155024|O1|Outcome|Socket Preference|Participant's indicated preference of socket type (preferred traditional socket, preferred direct manufactured socket, or no preference/difference)
659648|NCT01155024|O1|Outcome|Socket Preference|Participant's indicated preference of socket type (preferred traditional socket, preferred direct manufactured socket, or no preference/difference)
659649|NCT01155024|O2|Outcome|Direct Manufactured Socket|Direct manufactured prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
659650|NCT01155024|O1|Outcome|Traditional Socket|Traditional diagnostic prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
659651|NCT01155024|E2|Reported Event|Direct Manufactured Socket|Initial fitting of a direct manufactured prosthetic socket
659652|NCT01155024|E1|Reported Event|Traditional Socket|Initial fitting of a traditional diagnostic prosthetic socket
659653|NCT01155063|B1|Baseline|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
659654|NCT01155063|P1|Participant Flow|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 milligram (mg) oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
659655|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
659656|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
659657|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
659658|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
659659|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
659660|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
659661|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
659662|NCT01155063|E1|Reported Event|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
659663|NCT01155141|B1|Baseline|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
659664|NCT01155141|P1|Participant Flow|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
659665|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
659666|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
659667|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
659668|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
659669|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
659670|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
659671|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
659786|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659672|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
659673|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
659674|NCT01155141|E1|Reported Event|H.P. Acthar Gel|Patients were treated with 40 units subcutaneously (SC) weekly for 2 weeks, then dose increased to 80 units SC weekly for 2 weeks followed by 80 units SC twice weekly to complete 16 weeks of therapy.
659675|NCT01155154|B4|Baseline|Total|Total of all reporting groups
659676|NCT01155154|B3|Baseline|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
659677|NCT01155154|B2|Baseline|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
659678|NCT01155154|B1|Baseline|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
659679|NCT01155154|P3|Participant Flow|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
659680|NCT01155154|P2|Participant Flow|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
659681|NCT01155154|P1|Participant Flow|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
659682|NCT01155154|O3|Outcome|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
659683|NCT01155154|O2|Outcome|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
659684|NCT01155154|O1|Outcome|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
659685|NCT01155154|E3|Reported Event|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
659686|NCT01155154|E2|Reported Event|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
659687|NCT01155154|E1|Reported Event|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
659688|NCT01155167|B3|Baseline|Total|Total of all reporting groups
659689|NCT01155167|B2|Baseline|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659690|NCT01155167|B1|Baseline|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659691|NCT01155167|P2|Participant Flow|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659692|NCT01155167|P1|Participant Flow|Placebo|Two placebo topical lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659693|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659694|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659695|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659696|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659697|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659698|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659699|NCT01155167|E2|Reported Event|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659700|NCT01155167|E1|Reported Event|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
659701|NCT01155180|B3|Baseline|Total|Total of all reporting groups
659702|NCT01155180|B2|Baseline|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women
Placebo: Placebo-daily self injections for 6 months"
659703|NCT01155180|B1|Baseline|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women
Leptin: Hormone - daily self injections for 6 months"
659704|NCT01155180|P2|Participant Flow|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women
Placebo: Placebo"
659705|NCT01155180|P1|Participant Flow|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women
Leptin: Hormone - daily self injections for 6 months"
659706|NCT01155180|O2|Outcome|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women
Placebo: Placebo"
659707|NCT01155180|O1|Outcome|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women
Leptin: Hormone - daily self injections for 6 months"
659708|NCT01155180|E2|Reported Event|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women
Placebo: Placebo"
659787|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659709|NCT01155180|E1|Reported Event|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women
Leptin: Hormone - daily self injections for 6 months"
659710|NCT01155219|B3|Baseline|Total|Total of all reporting groups
659711|NCT01155219|B2|Baseline|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.
Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
659712|NCT01155219|B1|Baseline|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).
Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
659713|NCT01155219|P2|Participant Flow|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.
Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
659714|NCT01155219|P1|Participant Flow|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).
Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
659715|NCT01155219|O2|Outcome|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.
Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
659716|NCT01155219|O1|Outcome|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).
Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
659717|NCT01155219|E2|Reported Event|Xalatan®|"Latanoprost
One drop in the conjunctival sac of each eye in the evening"
659718|NCT01155219|E1|Reported Event|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % unpreserved timolol maleate gel)
One drop in the conjunctival sac of each eye in the morning"
659719|NCT01155323|B1|Baseline|Total Number of Participants|This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria.
659720|NCT01155323|P2|Participant Flow|Omafilcon A/Etafilcon A|omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second.
659721|NCT01155323|P1|Participant Flow|Etafilcon A/Omafilcon A|etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second.
659722|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
659723|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
659724|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
659725|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
659726|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
659727|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
659728|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
659729|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
659730|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
659731|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
659732|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
659733|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
659734|NCT01155323|E2|Reported Event|Omafilcon A|soft contact lens replaced daily, worn for one week.
659735|NCT01155323|E1|Reported Event|Etafilcon A|soft contact lens replaced daily, worn for one week.
659736|NCT01155336|B3|Baseline|Total|Total of all reporting groups
659737|NCT01155336|B2|Baseline|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
659738|NCT01155336|B1|Baseline|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
659739|NCT01155336|P2|Participant Flow|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
659740|NCT01155336|P1|Participant Flow|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
659741|NCT01155336|O2|Outcome|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
659742|NCT01155336|O1|Outcome|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
659743|NCT01155336|E2|Reported Event|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
659788|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659983|NCT01156012|O2|Outcome|Prostaglandin|"One drop of prostaglandin
Prostaglandin: One drop of prostaglandin at 9.00pm"
659744|NCT01155336|E1|Reported Event|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
659745|NCT01155466|B6|Baseline|Total|Total of all reporting groups
659746|NCT01155466|B5|Baseline|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659747|NCT01155466|B4|Baseline|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659748|NCT01155466|B3|Baseline|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659749|NCT01155466|B2|Baseline|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659750|NCT01155466|B1|Baseline|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659751|NCT01155466|P5|Participant Flow|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659752|NCT01155466|P4|Participant Flow|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659753|NCT01155466|P3|Participant Flow|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659754|NCT01155466|P2|Participant Flow|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659755|NCT01155466|P1|Participant Flow|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659756|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659757|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659940|NCT01155726|E2|Reported Event|Etafilcon A|Etafilcon A contact lenses
659758|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659759|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659760|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659761|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659762|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659763|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659764|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659765|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659766|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659767|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659768|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659769|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659770|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659771|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659772|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659773|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659774|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659775|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659776|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659777|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659778|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659779|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659780|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659781|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659782|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659783|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659784|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659785|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659789|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659790|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659791|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659792|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659793|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659794|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659795|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659796|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659797|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659798|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659799|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659800|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659801|NCT01155466|E5|Reported Event|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
659802|NCT01155466|E4|Reported Event|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
659803|NCT01155466|E3|Reported Event|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
659804|NCT01155466|E2|Reported Event|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
659805|NCT01155466|E1|Reported Event|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
659806|NCT01155479|B6|Baseline|Total|Total of all reporting groups
659807|NCT01155479|B5|Baseline|Rasagiline|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
659808|NCT01155479|B4|Baseline|Placebo|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
659809|NCT01155479|B3|Baseline|Preladenant 10 mg|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
659810|NCT01155479|B2|Baseline|Preladenant 5 mg|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
659811|NCT01155479|B1|Baseline|Preladenant 2 mg|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
659812|NCT01155479|P5|Participant Flow|Rasagiline|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
659813|NCT01155479|P4|Participant Flow|Placebo|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
659814|NCT01155479|P3|Participant Flow|Preladenant 10 mg|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
659815|NCT01155479|P2|Participant Flow|Preladenant 5 mg|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
659816|NCT01155479|P1|Participant Flow|Preladenant 2 mg|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
659817|NCT01155479|O5|Outcome|Rasagiline (Part 2)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
659818|NCT01155479|O4|Outcome|Placebo (Part 2)|Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
659819|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 2)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
659820|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 2)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
659821|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 2)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
659822|NCT01155479|O5|Outcome|Rasagiline (Part 2)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
659823|NCT01155479|O4|Outcome|Placebo (Part 2)|Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
659824|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 2)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
659980|NCT01156012|B1|Baseline|T2345|"One drop of T2345
T2345: One drop of T2345 at 9.00pm."
659825|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 2)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
659826|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 2)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
659827|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
659828|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
659829|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
659830|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
659831|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
659832|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
659833|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
659834|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
659835|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
659836|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
659837|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
659838|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
659839|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
659840|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
659841|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
659842|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
659843|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
659844|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks. The number of participants analyzed (200) represents the number of randomized and treated participants with at least one post-treatment value.
659845|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks. The number of participants analyzed (202) represents the number of randomized and treated participants with at least one post-treatment value.
659846|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
659847|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
659848|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
659849|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
659850|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
659851|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
659852|NCT01155479|E10|Reported Event|Rasagiline - Part 2|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 2).
659853|NCT01155479|E9|Reported Event|Placebo/Preladenant 5 Mg-Part 2|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg oral tablet in the PM for 26 weeks (Part 2).
659854|NCT01155479|E8|Reported Event|Preladenant 10 mg - Part 2|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 2).
659855|NCT01155479|E7|Reported Event|Preladenant 5 mg - Part 2|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 2).
659981|NCT01156012|P2|Participant Flow|Prostaglandin|"One drop of prostaglandin
Prostaglandin: One drop of prostaglandin at 9.00pm"
659856|NCT01155479|E6|Reported Event|Preladenant 2 mg - Part 2|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 2).
659857|NCT01155479|E5|Reported Event|Rasagiline - Part 1|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1).
659858|NCT01155479|E4|Reported Event|Placebo - Part 1|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1).
659859|NCT01155479|E3|Reported Event|Preladenant 10 mg - Part 1|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1).
659860|NCT01155479|E2|Reported Event|Preladenant 5 mg - Part 1|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1).
659861|NCT01155479|E1|Reported Event|Preladenant 2 mg - Part 1|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1).
659862|NCT01155531|B5|Baseline|Total|Total of all reporting groups
659863|NCT01155531|B4|Baseline|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659864|NCT01155531|B3|Baseline|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659865|NCT01155531|B2|Baseline|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659941|NCT01155726|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lenses
659942|NCT01155830|B4|Baseline|Total|Total of all reporting groups
659866|NCT01155531|B1|Baseline|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659867|NCT01155531|P4|Participant Flow|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659868|NCT01155531|P3|Participant Flow|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659869|NCT01155531|P2|Participant Flow|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659870|NCT01155531|P1|Participant Flow|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659871|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659872|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659873|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659874|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659875|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659876|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659877|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659878|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659879|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659880|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659881|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659882|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659883|NCT01155531|E4|Reported Event|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659884|NCT01155531|E3|Reported Event|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659885|NCT01155531|E2|Reported Event|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659886|NCT01155531|E1|Reported Event|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
659887|NCT01155570|B1|Baseline|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659888|NCT01155570|P1|Participant Flow|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659889|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659890|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659891|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659892|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659893|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659894|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659895|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659896|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659897|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659898|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659899|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659900|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659901|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
659902|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
660097|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
659903|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
659904|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659905|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
659906|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659907|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
659908|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659909|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659910|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659911|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659912|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659913|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659914|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659915|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659916|NCT01155570|E1|Reported Event|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
659917|NCT01155726|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
659918|NCT01155726|P4|Participant Flow|Etafilcon A, Masked, Partially Masked|Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
659919|NCT01155726|P3|Participant Flow|Etafilcon A, Masked, Unmasked|Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
659920|NCT01155726|P2|Participant Flow|Nelfilcon A, Masked, Partially Masked|Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
659921|NCT01155726|P1|Participant Flow|Nelfilcon A, Masked, Unmasked|Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
659922|NCT01155726|O16|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Partial (DACP)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
659923|NCT01155726|O15|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
659924|NCT01155726|O14|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Partial (DACP)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
659925|NCT01155726|O13|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
659926|NCT01155726|O12|Outcome|Etafilcon A, Pd 1 Masked (DACP), Pd 2 Partial|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
659927|NCT01155726|O11|Outcome|Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
659982|NCT01156012|P1|Participant Flow|T2345|"One drop of T2345
T2345: One drop of T2345 at 9.00pm"
659928|NCT01155726|O10|Outcome|Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Partial|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
659929|NCT01155726|O9|Outcome|Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
659930|NCT01155726|O8|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
659931|NCT01155726|O7|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
659932|NCT01155726|O6|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
659933|NCT01155726|O5|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
659934|NCT01155726|O4|Outcome|Etafilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
659935|NCT01155726|O3|Outcome|Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
659936|NCT01155726|O2|Outcome|Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
659937|NCT01155726|O1|Outcome|Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
659938|NCT01155726|E4|Reported Event|DACP|Nelfilcon A with comfort additive contact lenses
659939|NCT01155726|E3|Reported Event|1DAVM|Etafilcon A with comfort additive contact lenses
659943|NCT01155830|B3|Baseline|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
659944|NCT01155830|B2|Baseline|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
659945|NCT01155830|B1|Baseline|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
659946|NCT01155830|P3|Participant Flow|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
659947|NCT01155830|P2|Participant Flow|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
659948|NCT01155830|P1|Participant Flow|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
659949|NCT01155830|O3|Outcome|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
659950|NCT01155830|O2|Outcome|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
659951|NCT01155830|O1|Outcome|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
659952|NCT01155830|O3|Outcome|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
659953|NCT01155830|O2|Outcome|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
659954|NCT01155830|O1|Outcome|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
659955|NCT01155830|E3|Reported Event|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
659956|NCT01155830|E2|Reported Event|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
659957|NCT01155830|E1|Reported Event|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
659958|NCT01155869|B3|Baseline|Total|Total of all reporting groups
659959|NCT01155869|B2|Baseline|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
659960|NCT01155869|B1|Baseline|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
659961|NCT01155869|P2|Participant Flow|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
659962|NCT01155869|P1|Participant Flow|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
659963|NCT01155869|O2|Outcome|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
659964|NCT01155869|O1|Outcome|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
659965|NCT01155869|O2|Outcome|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
659966|NCT01155869|O1|Outcome|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
659967|NCT01155869|E2|Reported Event|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
659968|NCT01155869|E1|Reported Event|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
659969|NCT01155999|B3|Baseline|Total|Total of all reporting groups
659970|NCT01155999|B2|Baseline|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
659971|NCT01155999|B1|Baseline|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
659972|NCT01155999|P2|Participant Flow|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
659973|NCT01155999|P1|Participant Flow|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
659974|NCT01155999|O2|Outcome|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
659975|NCT01155999|O1|Outcome|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
659976|NCT01155999|E2|Reported Event|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
659977|NCT01155999|E1|Reported Event|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
659978|NCT01156012|B3|Baseline|Total|Total of all reporting groups
659979|NCT01156012|B2|Baseline|Prostaglandin|"One drop of prostaglandin
Prostaglandin: One drop of prostaglandin at 9.00pm"
659984|NCT01156012|O1|Outcome|T2345|"One drop of T2345
T2345: One drop of T2345 at 9.00pm."
659985|NCT01156012|E2|Reported Event|Prostaglandin|"One drop of prostaglandin
Prostaglandin: One drop of prostaglandin at 9.00pm"
659986|NCT01156012|E1|Reported Event|T2345|"One drop of T2345
T2345: One drop of T2345 at 9.00pm."
659987|NCT01156051|B3|Baseline|Total|Total of all reporting groups
659988|NCT01156051|B2|Baseline|Placebo Comparator|"Placebo control
Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg were started and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
659989|NCT01156051|B1|Baseline|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
Guanfacine extended-release tablets: Guanfacine extended-release tablets were started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
659990|NCT01156051|P2|Participant Flow|Control|Children who received a matching placebo tablet administered once daily in the morning in a flexible dosing protocol, with tablets identical to guanfacine extended release from 1mg to 4mg.
659991|NCT01156051|P1|Participant Flow|Treatment Group|Children who received (double blinded, randomized) guanfacine extended release tablets in a flexible dosing protocol, with doses ranging from 1mg to 4mg administered once daily in the morning.
659992|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control
Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
659993|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
659994|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control
Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
659995|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
659996|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control
Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
659997|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
659998|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control
Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
659999|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
660000|NCT01156051|E2|Reported Event|Placebo Comparator|"Placebo control
Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
660001|NCT01156051|E1|Reported Event|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
660002|NCT01156116|B3|Baseline|Total|Total of all reporting groups
660003|NCT01156116|B2|Baseline|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
660004|NCT01156116|B1|Baseline|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
660005|NCT01156116|P2|Participant Flow|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
660006|NCT01156116|P1|Participant Flow|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
660007|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
660008|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
660009|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
660010|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
660011|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
660012|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
660013|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
660014|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
660015|NCT01156116|E2|Reported Event|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
660016|NCT01156116|E1|Reported Event|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
660017|NCT01156142|B3|Baseline|Total|Total of all reporting groups
660018|NCT01156142|B2|Baseline|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
660062|NCT01156311|E1|Reported Event|Monotherapy Period: IFNß|A stable dose of one of the IFNß products for up to 8 weeks (until the first dose of BG00012).
660019|NCT01156142|B1|Baseline|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
660020|NCT01156142|P2|Participant Flow|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
660021|NCT01156142|P1|Participant Flow|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
660022|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
660023|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
660024|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
661582|NCT01159431|P2|Participant Flow|Control|Trigeminal Nerve Stimulation-Low Settings
660025|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
660026|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
660027|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
660028|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
660029|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
660030|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
660031|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
660032|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
660033|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
660034|NCT01156142|E2|Reported Event|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
660035|NCT01156142|E1|Reported Event|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
660036|NCT01156311|B3|Baseline|Total|Total of all reporting groups
660037|NCT01156311|B2|Baseline|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660038|NCT01156311|B1|Baseline|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660039|NCT01156311|P4|Participant Flow|Add-on Therapy Period: Dimethyl Fumarate Add-on to GA|"Dimethyl fumarate was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study."
660040|NCT01156311|P3|Participant Flow|Add-on Therapy Period: Dimethyl Fumarate Add-on to IFNß|"BG00012 (dimethyl fumarate) was to be administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months) as an add-on to a stable dose of IFNß.
Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study."
660141|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660041|NCT01156311|P2|Participant Flow|Monotherapy Period: Glatiramer Acetate (GA)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
660042|NCT01156311|P1|Participant Flow|Monotherapy Period: Interferon Beta (IFNß)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
660043|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660044|NCT01156311|O1|Outcome|Interferon Beta 1a (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660045|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660046|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660047|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660048|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660049|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660050|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660051|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660052|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660053|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660054|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660055|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660056|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660057|NCT01156311|O2|Outcome|Monotherapy Period: GA|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
660058|NCT01156311|O1|Outcome|Monotherapy Period: IFNß|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
660059|NCT01156311|E4|Reported Event|Add-on Therapy Period: GA and BG00012|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660060|NCT01156311|E3|Reported Event|Add-on Therapy Period: IFNß and BG00012|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
660061|NCT01156311|E2|Reported Event|Monotherapy Period: GA|A stable dose of GA for up to 8 weeks (until the first dose of BG00012).
660063|NCT01156363|B1|Baseline|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers."
660064|NCT01156363|P1|Participant Flow|Mircera|"Participants received Mircera (epoetin beta-methoxy polyethylene glycol) 80, 120, 200, or 360 micrograms (mcg) (based on the weekly dose of erythropoiesis stimulating agent [ESA] participant received in the week preceding the switch to Mircera [Week -1]) by intravenous (IV) or subcutaneous (SC) injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on hemoglobin (Hb) level.
This arm includes participants enrolled at all 3 centers."
660065|NCT01156363|O1|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers."
660066|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers."
660067|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH)."
660068|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)."
660069|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at China Medical University Hospital (CMUH)."
660070|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers."
660071|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at BTCH."
660072|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at KMUH."
660073|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at CMUH."
660074|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers."
660075|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at BTCH."
660076|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at KMUH."
660077|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at CMUH."
660078|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers."
660079|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH)."
660080|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)."
660081|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at China Medical University Hospital (CMUH)."
660082|NCT01156363|E1|Reported Event|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers."
660083|NCT01156376|B4|Baseline|Total|Total of all reporting groups
660084|NCT01156376|B3|Baseline|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660085|NCT01156376|B2|Baseline|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660086|NCT01156376|B1|Baseline|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660087|NCT01156376|P3|Participant Flow|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660088|NCT01156376|P2|Participant Flow|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660089|NCT01156376|P1|Participant Flow|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660090|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660091|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660092|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660093|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660094|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660095|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660096|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660098|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660099|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660100|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660101|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660102|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660103|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660104|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660105|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660106|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660107|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660108|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660109|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660110|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660111|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660112|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660113|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660114|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660115|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660116|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660117|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660118|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660119|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660120|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660121|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660122|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660123|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660124|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660125|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660126|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660127|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660128|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660129|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660130|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660131|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660132|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660133|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660134|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660135|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660136|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660137|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660138|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660139|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660140|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660142|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660143|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660144|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660145|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660146|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660147|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660148|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660149|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660150|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660151|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660152|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660153|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660154|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660155|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660156|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660157|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660158|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660159|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660160|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660161|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660162|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660163|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660164|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660165|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660166|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660167|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660168|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660169|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660170|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660171|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660172|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660173|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660174|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660175|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660176|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660177|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660178|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660179|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660180|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660181|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660182|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660183|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660184|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660185|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660186|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660187|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660188|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660189|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660190|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660191|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660192|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660193|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660194|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660195|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660196|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660197|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660198|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660199|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660200|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660201|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660202|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660203|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660204|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660205|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660206|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660207|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660208|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660209|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660210|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660211|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660212|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660213|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660214|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660215|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660216|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660217|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660218|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660219|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660220|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660221|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660222|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660223|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660224|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660225|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660226|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660227|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660228|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660229|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660230|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660231|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660232|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660233|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660234|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660235|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660236|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660237|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660238|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660239|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660240|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660241|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660242|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660243|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660244|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660245|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660246|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660247|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660248|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660249|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660250|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660251|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660252|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660253|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660254|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660255|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660256|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660257|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660258|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660259|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660260|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660261|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660262|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660263|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660264|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660265|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660266|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660267|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660268|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660269|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660270|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660271|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660272|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660273|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660274|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660275|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660276|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660277|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660278|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660279|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660280|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660281|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660282|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660283|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660284|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660285|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660286|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660287|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660288|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660289|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660290|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660291|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660292|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660293|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660294|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660295|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660296|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660297|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660298|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660299|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660300|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660301|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660302|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660303|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660304|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660305|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660306|NCT01156376|E3|Reported Event|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
660307|NCT01156376|E2|Reported Event|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
660308|NCT01156376|E1|Reported Event|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
660309|NCT01156480|B3|Baseline|Total|Total of all reporting groups
660310|NCT01156480|B2|Baseline|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
660311|NCT01156480|B1|Baseline|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
660312|NCT01156480|P2|Participant Flow|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
660313|NCT01156480|P1|Participant Flow|Hydrocortisone|hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous route for 3 days, then 2mg/kg/day divided every 8 hours IV for 1 day, then 1.5mg/kg/day divided every 8 hours IV for 1 day, then 1mg/kg/day divided every 12 hours for 1 day, then 0.5mg/kg/day in single dose for one day. Placebo group will receive equal volume of placebo on the same schedule. The first dose of study drug will be given within 6 hours of NEC diagnosis, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
660314|NCT01156480|O2|Outcome|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
660315|NCT01156480|O1|Outcome|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
660529|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
661583|NCT01159431|P1|Participant Flow|Active|Trigeminal Nerve Stimulation-High Settings
660316|NCT01156480|O2|Outcome|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
660317|NCT01156480|O1|Outcome|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
660318|NCT01156480|E2|Reported Event|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
660319|NCT01156480|E1|Reported Event|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
660320|NCT01156532|B1|Baseline|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
660321|NCT01156532|P1|Participant Flow|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
660322|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
660323|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
660324|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
660325|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
660326|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
660352|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
660327|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
660328|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
660329|NCT01156532|E1|Reported Event|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
660330|NCT01156571|B3|Baseline|Total|Total of all reporting groups
660331|NCT01156571|B2|Baseline|Clopidogrel Treatment Arm|"Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.
Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.
At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose."
660530|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
661584|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
660332|NCT01156571|B1|Baseline|Cangrelor Treatment Arm|"Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.
Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.
Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose."
660333|NCT01156571|P2|Participant Flow|Clopidogrel Treatment Arm|"Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.
Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.
At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose."
660334|NCT01156571|P1|Participant Flow|Cangrelor Treatment Arm|"Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.
Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.
Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose."
660335|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
660336|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
660337|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
660338|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
660339|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
660340|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
660341|NCT01156571|E2|Reported Event|Clopidogrel Treatment Arm|
660342|NCT01156571|E1|Reported Event|Cangrelor Treatment Arm|
660343|NCT01156597|B3|Baseline|Total|Total of all reporting groups
660344|NCT01156597|B2|Baseline|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
660345|NCT01156597|B1|Baseline|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level
The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
660346|NCT01156597|P2|Participant Flow|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
660347|NCT01156597|P1|Participant Flow|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level
pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
660348|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
660349|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level
The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
660350|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
660351|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level
pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
660353|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level
The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
660354|NCT01156597|E2|Reported Event|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
660355|NCT01156597|E1|Reported Event|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level
pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
660356|NCT01156701|B1|Baseline|All Patients Included in the Analysis|All patients at least 5 years old enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009
660357|NCT01156701|P4|Participant Flow|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
660358|NCT01156701|P3|Participant Flow|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
661585|NCT01159431|O1|Outcome|Active|Trigeminal Nerve Stimulation-High Settings
660359|NCT01156701|P2|Participant Flow|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660360|NCT01156701|P1|Participant Flow|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660361|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
660362|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660363|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660364|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660365|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
660366|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660367|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660368|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660369|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
660370|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660371|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660372|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660373|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
660374|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660375|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660376|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
661082|NCT01150981|O1|Outcome|Rosiglitazone|One 8mg capsule daily for 6 weeks.
660377|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
660378|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660379|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660380|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660381|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
660382|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660383|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660384|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660385|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
660386|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660387|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660388|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660389|NCT01156701|E4|Reported Event|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
660390|NCT01156701|E3|Reported Event|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660391|NCT01156701|E2|Reported Event|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660392|NCT01156701|E1|Reported Event|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
660393|NCT01156792|B1|Baseline|All Treatments Combined|In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
660394|NCT01156792|P1|Participant Flow|All Treatments Combined|In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
660395|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660396|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660397|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660508|NCT01157078|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660398|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660399|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
660400|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660401|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660402|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660531|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660403|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660404|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
660405|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660406|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660407|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660408|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660409|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
660410|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660411|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660412|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660413|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660414|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
661083|NCT01150981|O2|Outcome|Placebo|One capsule daily for 6 weeks.
660415|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660416|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660417|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660418|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660419|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
660532|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660533|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660420|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660421|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660422|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660423|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660424|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
660425|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660426|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660427|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660428|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660429|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
660430|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660509|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
661084|NCT01150981|O1|Outcome|Rosiglitazone|One 8mg capsule daily for 6 weeks.
660431|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660432|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660433|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660434|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
660435|NCT01156792|O3|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660436|NCT01156792|O2|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660534|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660535|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660437|NCT01156792|O1|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660438|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660439|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660440|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660441|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660442|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
660443|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660444|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660445|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660446|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660447|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
661085|NCT01150981|E2|Reported Event|Placebo|One capsule daily for 6 weeks.
660448|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660449|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660450|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660451|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660452|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
660453|NCT01156792|E5|Reported Event|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660536|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660454|NCT01156792|E4|Reported Event|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
660455|NCT01156792|E3|Reported Event|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660456|NCT01156792|E2|Reported Event|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
660457|NCT01156792|E1|Reported Event|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
660458|NCT01156844|B5|Baseline|Total|Total of all reporting groups
660459|NCT01156844|B4|Baseline|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660460|NCT01156844|B3|Baseline|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660461|NCT01156844|B2|Baseline|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660462|NCT01156844|B1|Baseline|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660463|NCT01156844|P4|Participant Flow|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660510|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660464|NCT01156844|P3|Participant Flow|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660465|NCT01156844|P2|Participant Flow|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660466|NCT01156844|P1|Participant Flow|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660467|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
660468|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660469|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660470|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
660471|NCT01156844|O2|Outcome|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660472|NCT01156844|O1|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660473|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
660474|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660475|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660476|NCT01156844|O4|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660511|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660477|NCT01156844|O3|Outcome|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660478|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660479|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660480|NCT01156844|E4|Reported Event|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660481|NCT01156844|E3|Reported Event|Indacaterol 150 ug (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660482|NCT01156844|E2|Reported Event|Indacaterol 75 ug (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660483|NCT01156844|E1|Reported Event|Indacaterol 37.5 ug (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
660484|NCT01156987|B3|Baseline|Total|Total of all reporting groups
660485|NCT01156987|B2|Baseline|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.
Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
an IV line is placed by nurse,
patient is placed in the 4 T MRI scanner at CMRR,
initial scout images and manual linear shims are adjusted,
Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
continuous SWIFT acquisition begins immediately before contrast injection,
contrast injection,
continuous SWIFT acquisition continues for 12 min after contrast,
late enhancement images may also be obtained.
10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
660486|NCT01156987|B1|Baseline|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.
Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
an IV line is placed by nurse,
patient is placed in the 4 T MRI scanner at CMRR,
initial scout images and manual linear shims are adjusted,
Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
continuous SWIFT acquisition begins immediately before contrast injection,
contrast injection,
continuous SWIFT acquisition continues for 12 min after contrast,
late enhancement images may also be obtained.
10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
660487|NCT01156987|P2|Participant Flow|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.
Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
an IV line is placed by nurse,
patient is placed in the 4 T MRI scanner at CMRR,
initial scout images and manual linear shims are adjusted,
Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
continuous SWIFT acquisition begins immediately before contrast injection,
contrast injection,
continuous SWIFT acquisition continues for 12 min after contrast,
late enhancement images may also be obtained. 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
660512|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660513|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660488|NCT01156987|P1|Participant Flow|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.
Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
an IV line is placed by nurse,
patient is placed in the 4 T MRI scanner at CMRR,
initial scout images and manual linear shims are adjusted,
Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
continuous SWIFT acquisition begins immediately before contrast injection,
contrast injection,
continuous SWIFT acquisition continues for 12 min after contrast,
late enhancement images may also be obtained.
10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
660489|NCT01156987|O2|Outcome|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.
Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
an IV line is placed by nurse,
patient is placed in the 4 T MRI scanner at CMRR,
initial scout images and manual linear shims are adjusted,
Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
continuous SWIFT acquisition begins immediately before contrast injection,
contrast injection,
continuous SWIFT acquisition continues for 12 min after contrast,
late enhancement images may also be obtained.
10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
660490|NCT01156987|O1|Outcome|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.
Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
an IV line is placed by nurse,
patient is placed in the 4 T MRI scanner at CMRR,
initial scout images and manual linear shims are adjusted,
Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
continuous SWIFT acquisition begins immediately before contrast injection,
contrast injection,
continuous SWIFT acquisition continues for 12 min after contrast,
late enhancement images may also be obtained.
10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
660537|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660538|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660539|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
661586|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
660491|NCT01156987|E2|Reported Event|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.
Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
an IV line is placed by nurse,
patient is placed in the 4 T MRI scanner at CMRR,
initial scout images and manual linear shims are adjusted,
Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
continuous SWIFT acquisition begins immediately before contrast injection,
contrast injection,
continuous SWIFT acquisition continues for 12 min after contrast,
late enhancement images may also be obtained.
10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
660492|NCT01156987|E1|Reported Event|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.
Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
an IV line is placed by nurse,
patient is placed in the 4 T MRI scanner at CMRR,
initial scout images and manual linear shims are adjusted,
Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
continuous SWIFT acquisition begins immediately before contrast injection,
contrast injection,
continuous SWIFT acquisition continues for 12 min after contrast,
late enhancement images may also be obtained.
10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
660493|NCT01157065|B3|Baseline|Total|Total of all reporting groups
660494|NCT01157065|B2|Baseline|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
660495|NCT01157065|B1|Baseline|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
660496|NCT01157065|P2|Participant Flow|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
660497|NCT01157065|P1|Participant Flow|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
660498|NCT01157065|O2|Outcome|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
660499|NCT01157065|O1|Outcome|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
660500|NCT01157065|O2|Outcome|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
660501|NCT01157065|O1|Outcome|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
660502|NCT01157065|E2|Reported Event|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
660503|NCT01157065|E1|Reported Event|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
660504|NCT01157078|B3|Baseline|Total|Total of all reporting groups
660505|NCT01157078|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660506|NCT01157078|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660507|NCT01157078|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
661086|NCT01150981|E1|Reported Event|Rosiglitazone|One 8mg capsule daily for 6 weeks.
660514|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660515|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660516|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660517|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660518|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660519|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660520|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660521|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660522|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660523|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660524|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660525|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660526|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660527|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660528|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660540|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660541|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660542|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660543|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660544|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660545|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660546|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660547|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660548|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660549|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660550|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660551|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660552|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660553|NCT01157078|E2|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
660554|NCT01157078|E1|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
660555|NCT01157117|B4|Baseline|Total|Total of all reporting groups
660556|NCT01157117|B3|Baseline|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
660557|NCT01157117|B2|Baseline|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660558|NCT01157117|B1|Baseline|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660559|NCT01157117|P3|Participant Flow|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
660616|NCT01157169|E2|Reported Event|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
660560|NCT01157117|P2|Participant Flow|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660561|NCT01157117|P1|Participant Flow|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660562|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
660563|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660638|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660639|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
661587|NCT01159431|O1|Outcome|Treatment|Trigeminal Nerve Stimulation-High Settings
660564|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660565|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
660566|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660567|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660568|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
660569|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660570|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660571|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
660617|NCT01157169|E1|Reported Event|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
660572|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660573|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660574|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
660575|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660640|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660641|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660642|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660643|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660576|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660577|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
660578|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660579|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660580|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660581|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660618|NCT01157182|B3|Baseline|Total|Total of all reporting groups
660619|NCT01157182|B2|Baseline|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
660620|NCT01157182|B1|Baseline|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
660582|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660583|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660584|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660585|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660586|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
661588|NCT01159431|O2|Outcome|Control|
660587|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660588|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660589|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660590|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660591|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660621|NCT01157182|P2|Participant Flow|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
660592|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660593|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660594|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660595|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660596|NCT01157117|E3|Reported Event|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
660597|NCT01157117|E2|Reported Event|Placebo for Omalizumab/Milk OIT|Placebo for omalizumab: Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the omalizumab treatment group (determined by the participant's IgE level and weight).
660644|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660645|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660646|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660598|NCT01157117|E1|Reported Event|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
660599|NCT01157169|B3|Baseline|Total|Total of all reporting groups
660600|NCT01157169|B2|Baseline|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
660601|NCT01157169|B1|Baseline|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
660602|NCT01157169|P2|Participant Flow|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
660603|NCT01157169|P1|Participant Flow|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
660604|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
660605|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
660606|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
660607|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
660608|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
660609|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
660610|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
660611|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
660612|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
660613|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
660614|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
660615|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
660979|NCT01150461|B3|Baseline|Total|Total of all reporting groups
660622|NCT01157182|P1|Participant Flow|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
660623|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660624|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660625|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660626|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660627|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660628|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660629|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660630|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660631|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660632|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660633|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660634|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660635|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660636|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660637|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660694|NCT01150097|E1|Reported Event|Reduced TAC, Month 36|Reduced TAC, Month 36
660647|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660648|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660649|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660650|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660651|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660652|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660653|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660654|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660655|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660656|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660657|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660658|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660659|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660660|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660661|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660662|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660663|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
660664|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
660665|NCT01157182|E2|Reported Event|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
660666|NCT01157182|E1|Reported Event|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
660667|NCT01150097|B4|Baseline|Total|Total of all reporting groups
660668|NCT01150097|B3|Baseline|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
660669|NCT01150097|B2|Baseline|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
660670|NCT01150097|B1|Baseline|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
660671|NCT01150097|P3|Participant Flow|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
660672|NCT01150097|P2|Participant Flow|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
660673|NCT01150097|P1|Participant Flow|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
660674|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
660675|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
660980|NCT01150461|B2|Baseline|Placebo|
660981|NCT01150461|B1|Baseline|Losartan 50 mg PO BID|
660676|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
660677|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
660678|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
660679|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
660680|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
660681|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
660682|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
660683|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
660684|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
660685|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
660686|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
660687|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
660688|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
660689|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
660690|NCT01150097|E5|Reported Event|TAC Elimination, Month 48|TAC Elimination, Month 48
660691|NCT01150097|E4|Reported Event|Reduced RAD + TAC, Month 48|Reduced RAD + TAC, Month 48
660692|NCT01150097|E3|Reported Event|TAC Control, Month 36|TAC Control, Month 36
660693|NCT01150097|E2|Reported Event|TAC Elimination, Month 36|TAC Elimination, Month 36
660696|NCT01150123|B18|Baseline|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
660697|NCT01150123|B17|Baseline|20 μg-2 Inj-MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660698|NCT01150123|B16|Baseline|20 μg-1 Inj –MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660699|NCT01150123|B15|Baseline|5μg-2 Inj –MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660700|NCT01150123|B14|Baseline|5μg-1 Inj –MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660701|NCT01150123|B13|Baseline|20 μg-2 Inj –MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
660702|NCT01150123|B12|Baseline|20 μg-1 Inj –MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660703|NCT01150123|B11|Baseline|5μg-2 Inj –MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
660704|NCT01150123|B10|Baseline|5μg-1 Inj –MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660705|NCT01150123|B9|Baseline|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart t
660706|NCT01150123|B8|Baseline|20 μg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660707|NCT01150123|B7|Baseline|20 μg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660708|NCT01150123|B6|Baseline|5μg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660709|NCT01150123|B5|Baseline|5μg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660710|NCT01150123|B4|Baseline|20 μg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660711|NCT01150123|B3|Baseline|20 μg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660712|NCT01150123|B2|Baseline|5μg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660713|NCT01150123|B1|Baseline|5μg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660714|NCT01150123|P18|Participant Flow|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
660715|NCT01150123|P17|Participant Flow|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660716|NCT01150123|P16|Participant Flow|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660717|NCT01150123|P15|Participant Flow|5 µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660718|NCT01150123|P14|Participant Flow|5 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660719|NCT01150123|P13|Participant Flow|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
660982|NCT01150461|P2|Participant Flow|Placebo|
660983|NCT01150461|P1|Participant Flow|Losartan 50 mg BID|
660720|NCT01150123|P12|Participant Flow|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660721|NCT01150123|P11|Participant Flow|5 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
660722|NCT01150123|P10|Participant Flow|5 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660723|NCT01150123|P9|Participant Flow|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660724|NCT01150123|P8|Participant Flow|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660725|NCT01150123|P7|Participant Flow|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660726|NCT01150123|P6|Participant Flow|5 µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660727|NCT01150123|P5|Participant Flow|5 µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660728|NCT01150123|P4|Participant Flow|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660729|NCT01150123|P3|Participant Flow|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660730|NCT01150123|P2|Participant Flow|5 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660731|NCT01150123|P1|Participant Flow|5 µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660732|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
660733|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660734|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
661140|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
660735|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660736|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660737|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
660738|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660739|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
660740|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660741|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660742|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660743|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660744|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660745|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660746|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660747|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660748|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660749|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660750|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
660751|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660752|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660753|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660754|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660755|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
660756|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660757|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
660984|NCT01150461|O2|Outcome|Placebo|
660985|NCT01150461|O1|Outcome|Losartan 50 mg PO BID|
660986|NCT01150461|O2|Outcome|Placebo|
660758|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660759|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660760|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660761|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660762|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660763|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660764|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660765|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660766|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660767|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660768|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
660769|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660770|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660771|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660772|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660773|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
660774|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660775|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
660776|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660777|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660778|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660779|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660780|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660781|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660782|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660783|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660784|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660785|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660786|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
660787|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660788|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660789|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660790|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660791|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
660792|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660793|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
660794|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660795|NCT01150123|O18|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
660796|NCT01150123|O17|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660797|NCT01150123|O16|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660798|NCT01150123|O15|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660799|NCT01150123|O14|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660800|NCT01150123|O13|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
660801|NCT01150123|O12|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660802|NCT01150123|O11|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
660803|NCT01150123|O10|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660804|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660805|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660806|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660807|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660808|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660809|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660810|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660811|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660812|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660813|NCT01150123|O18|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
660814|NCT01150123|O17|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
661589|NCT01159431|O1|Outcome|Treatment|
660815|NCT01150123|O16|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660816|NCT01150123|O15|Outcome|5 µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660817|NCT01150123|O14|Outcome|5 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660818|NCT01150123|O13|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
660819|NCT01150123|O12|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660820|NCT01150123|O11|Outcome|5 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
660821|NCT01150123|O10|Outcome|5 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660822|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660823|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660824|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660825|NCT01150123|O6|Outcome|5 µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660826|NCT01150123|O5|Outcome|5 µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660827|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660828|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660829|NCT01150123|O2|Outcome|5 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660830|NCT01150123|O1|Outcome|5 µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660831|NCT01150123|O18|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
660832|NCT01150123|O17|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660833|NCT01150123|O16|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660834|NCT01150123|O15|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660835|NCT01150123|O14|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660836|NCT01150123|O13|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
660987|NCT01150461|O1|Outcome|Losartan 50 mg PO BID|
660988|NCT01150461|E2|Reported Event|Placebo|
660837|NCT01150123|O12|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660838|NCT01150123|O11|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
660839|NCT01150123|O10|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660840|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660841|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660842|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660843|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660844|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660845|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660846|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660847|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660848|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660849|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660850|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660851|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660852|NCT01150123|O6|Outcome|5 µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660853|NCT01150123|O5|Outcome|5 µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660854|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
661590|NCT01159431|O4|Outcome|Treatment Group-Double Blind Period|
660855|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660856|NCT01150123|O2|Outcome|5 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660857|NCT01150123|O1|Outcome|5 µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660858|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660859|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660860|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660861|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660862|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660863|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660864|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660865|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660866|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660867|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660868|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660869|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660870|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660871|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660872|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660873|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660874|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660875|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660876|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660877|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660989|NCT01150461|E1|Reported Event|Losartan 50 PO mg BID|
660878|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660879|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660880|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660881|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660882|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660883|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660884|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660885|NCT01150123|E18|Reported Event|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
660886|NCT01150123|E17|Reported Event|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660887|NCT01150123|E16|Reported Event|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660888|NCT01150123|E15|Reported Event|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
660889|NCT01150123|E14|Reported Event|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
660890|NCT01150123|E13|Reported Event|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
660891|NCT01150123|E12|Reported Event|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660892|NCT01150123|E11|Reported Event|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
660893|NCT01150123|E10|Reported Event|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
660894|NCT01150123|E9|Reported Event|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
660895|NCT01150123|E8|Reported Event|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
660896|NCT01150123|E7|Reported Event|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
660897|NCT01150123|E6|Reported Event|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
660898|NCT01150123|E5|Reported Event|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
660899|NCT01150123|E4|Reported Event|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
660900|NCT01150123|E3|Reported Event|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
660901|NCT01150123|E2|Reported Event|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
660902|NCT01150123|E1|Reported Event|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
660903|NCT01150357|B4|Baseline|Total|Total of all reporting groups
660904|NCT01150357|B3|Baseline|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660905|NCT01150357|B2|Baseline|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660906|NCT01150357|B1|Baseline|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight greater than or equal to (≥) 20 kilogram (kg) to less than (< ) 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and less than or equal to (≤)150 kg received 25 mg of aliskiren.
660907|NCT01150357|P3|Participant Flow|Aliskiren High (150/300/600 mg)|"During Phase 1: Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 52 participants switched to placebo treatment."
660908|NCT01150357|P2|Participant Flow|Aliskiren Mid (37.5/75/150 mg)|"During Phase 1: Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
During Phase 2: 30 participants continued the aliskiren treatment from Phase 1, while 21 participants switched to placebo treatment."
660909|NCT01150357|P1|Participant Flow|Aliskiren Low (6.25/12.5/25 mg)|"During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 57 participants switched to placebo treatment."
660990|NCT01150474|B3|Baseline|Total|Total of all reporting groups
660910|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660911|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660912|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660913|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660914|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660915|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660916|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660917|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660918|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660919|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660920|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660921|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660922|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660923|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660924|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660925|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
660926|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660927|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
660928|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660929|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
660930|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660931|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660932|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660933|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660934|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
660935|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660936|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
660937|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660938|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
660939|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660940|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660941|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660942|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660943|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
660944|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
661591|NCT01159431|O3|Outcome|Treatment Group-Baseline|
660945|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
660946|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660947|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
660948|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660949|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660950|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660951|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660952|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
660953|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660954|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
660955|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660956|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
660957|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660958|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660959|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660960|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660961|NCT01150357|E9|Reported Event|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
660962|NCT01150357|E8|Reported Event|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules(37.5/75/150 mg) once daily.
660963|NCT01150357|E7|Reported Event|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
660964|NCT01150357|E6|Reported Event|Phase 2: Aliskiren High (150/300/600 mg)|"Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and
≤ 150 kg received 600 mg of aliskiren."
660965|NCT01150357|E5|Reported Event|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660966|NCT01150357|E4|Reported Event|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660967|NCT01150357|E3|Reported Event|Phase 1: Aliskiren High (150/300/600 mg)|Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
660968|NCT01150357|E2|Reported Event|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
660969|NCT01150357|E1|Reported Event|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
660970|NCT01150409|B3|Baseline|Total|Total of all reporting groups
661141|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
660971|NCT01150409|B2|Baseline|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)
Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
660972|NCT01150409|B1|Baseline|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)
hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)
Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
660973|NCT01150409|P2|Participant Flow|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)
Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
660974|NCT01150409|P1|Participant Flow|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)
hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)
Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
660975|NCT01150409|O2|Outcome|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)
Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
660976|NCT01150409|O1|Outcome|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)
hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)
Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
660977|NCT01150409|E2|Reported Event|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)
Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
660978|NCT01150409|E1|Reported Event|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)
hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)
Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
660991|NCT01150474|B2|Baseline|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
660992|NCT01150474|B1|Baseline|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
660993|NCT01150474|P2|Participant Flow|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
660994|NCT01150474|P1|Participant Flow|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
660995|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
660996|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
660997|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
660998|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
660999|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661000|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661001|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661002|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661003|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661004|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661005|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661006|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661007|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661008|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661009|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661010|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661011|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661012|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661013|NCT01150474|E2|Reported Event|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661014|NCT01150474|E1|Reported Event|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
661015|NCT01150500|B1|Baseline|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
661016|NCT01150500|P1|Participant Flow|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
661017|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
661018|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
661019|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
661050|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661453|NCT01158378|O1|Outcome|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
661020|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
661021|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
661022|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
661023|NCT01150500|E1|Reported Event|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
661024|NCT01150760|B3|Baseline|Total|Total of all reporting groups
661025|NCT01150760|B2|Baseline|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661026|NCT01150760|B1|Baseline|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661027|NCT01150760|P2|Participant Flow|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661028|NCT01150760|P1|Participant Flow|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661029|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661142|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
661030|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661031|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661032|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661033|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661034|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661035|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661036|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661037|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661038|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661039|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661040|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661041|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661042|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661043|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661044|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661045|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661046|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661047|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661048|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661049|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661051|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661052|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661053|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661054|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661055|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661056|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661057|NCT01150760|E2|Reported Event|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
661058|NCT01150760|E1|Reported Event|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
661059|NCT01150903|B3|Baseline|Total|Total of all reporting groups
661060|NCT01150903|B2|Baseline|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
661061|NCT01150903|B1|Baseline|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
661062|NCT01150903|P2|Participant Flow|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
661063|NCT01150903|P1|Participant Flow|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
661064|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
661065|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
661066|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
661067|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
661068|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
661069|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
661070|NCT01150903|O2|Outcome|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
661071|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
661072|NCT01150903|O2|Outcome|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
661073|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
661074|NCT01150903|E2|Reported Event|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
661075|NCT01150903|E1|Reported Event|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
661076|NCT01150981|B3|Baseline|Total|Total of all reporting groups
661077|NCT01150981|B2|Baseline|Placebo|One capsule daily for 6 weeks.
661078|NCT01150981|B1|Baseline|Rosiglitazone|One 8mg capsule daily for 6 weeks.
661079|NCT01150981|P2|Participant Flow|Placebo|One capsule daily for 6 weeks.
661080|NCT01150981|P1|Participant Flow|Rosiglitazone|One 8mg capsule daily for 6 weeks.
661087|NCT01151020|B1|Baseline|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
661088|NCT01151020|P1|Participant Flow|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
661089|NCT01151020|O1|Outcome|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
661090|NCT01151020|O1|Outcome|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
661091|NCT01151020|E1|Reported Event|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
661092|NCT01151046|B3|Baseline|Total|Total of all reporting groups
661093|NCT01151046|B2|Baseline|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
661094|NCT01151046|B1|Baseline|MM-121 + Exemestane|MM-121 and Exemestane: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
661095|NCT01151046|P2|Participant Flow|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
661143|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
661096|NCT01151046|P1|Participant Flow|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
661097|NCT01151046|O2|Outcome|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
661098|NCT01151046|O1|Outcome|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
661099|NCT01151046|O4|Outcome|HRG Low: MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
661100|NCT01151046|O3|Outcome|HRG Low: Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
661101|NCT01151046|O2|Outcome|HRG High: Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
661102|NCT01151046|O1|Outcome|HRG High: MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
661103|NCT01151046|O2|Outcome|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
661104|NCT01151046|O1|Outcome|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
661105|NCT01151046|E2|Reported Event|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
661106|NCT01151046|E1|Reported Event|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
661107|NCT01151085|B1|Baseline|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
661108|NCT01151085|P1|Participant Flow|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
661109|NCT01151085|O3|Outcome|Severe Infection|Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
661110|NCT01151085|O2|Outcome|Moderate Infection|Participants with moderate infection who taking Voriconazole according to Japanese Package Insert.
661111|NCT01151085|O1|Outcome|Mild Infection|Participants with mild infection who taking Voriconazole according to Japanese Package Insert.
661112|NCT01151085|O2|Outcome|Without Past History|Participants without Past History who taking Voriconazole according to Japanese Package Insert.
661113|NCT01151085|O1|Outcome|With Past History|Participants with Past History who taking Voriconazole according to Japanese Package Insert.
661114|NCT01151085|O3|Outcome|Severe Infection|Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
661115|NCT01151085|O2|Outcome|Moderate Infection|Participants with moderate infection who taking Voriconazole according to Japanese Package Insert.
661116|NCT01151085|O1|Outcome|Mild Infection|Participants with mild infection who taking Voriconazole according to Japanese Package Insert.
661117|NCT01151085|O2|Outcome|Female|Female Participants taking Voriconazole according to Japanese Package Insert.
661118|NCT01151085|O1|Outcome|Male|Male Participants taking Voriconazole according to Japanese Package Insert.
661119|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
661120|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
661121|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
661122|NCT01151085|E1|Reported Event|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
661123|NCT01151098|B1|Baseline|Extension Phase (BTDS 5, 10 or 20)|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
662092|NCT01161329|O2|Outcome|Group Exercise Program|High-Intensity Functional Exercise Program
661124|NCT01151098|P1|Participant Flow|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
661125|NCT01151098|O1|Outcome|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10, or 20) applied for 7-day wear.
661126|NCT01151098|E1|Reported Event|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
661127|NCT01151137|B3|Baseline|Total|Total of all reporting groups
661128|NCT01151137|B2|Baseline|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
661129|NCT01151137|B1|Baseline|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
661130|NCT01151137|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
661131|NCT01151137|P1|Participant Flow|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
661132|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
661133|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
661134|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
661135|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
661136|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
661137|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
661138|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
661139|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
661282|NCT01151436|O1|Outcome|Hyaluronic Acid|
661144|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
661145|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
661146|NCT01151137|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
661147|NCT01151137|E1|Reported Event|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
661148|NCT01151189|B3|Baseline|Total|Total of all reporting groups
661149|NCT01151189|B2|Baseline|MVA85A/AERAS-485|"MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.
MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485."
661150|NCT01151189|B1|Baseline|Placebo|Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.
661151|NCT01151189|P2|Participant Flow|MVA85A/AERAS-485|"MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.
MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485."
661152|NCT01151189|P1|Participant Flow|Placebo|"The placebo is a licensed product manufactured by Allermed, Inc. and is used for evaluation of delayed-type of hypersensitivity reactions in adults.
Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo."
661153|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
661154|NCT01151189|O1|Outcome|Placebo|
661155|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
661156|NCT01151189|O1|Outcome|Placebo|
661157|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
661158|NCT01151189|O1|Outcome|Placebo|
661159|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
661160|NCT01151189|O1|Outcome|Placebo|
661161|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
661162|NCT01151189|O1|Outcome|Placebo|
661163|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
661164|NCT01151189|O1|Outcome|Placebo|
661165|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
661166|NCT01151189|O1|Outcome|Placebo|
661167|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
661168|NCT01151189|O1|Outcome|Placebo|
661169|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
661170|NCT01151189|O1|Outcome|Placebo|
661171|NCT01151189|E2|Reported Event|MVA85A/AERAS-485|
661172|NCT01151189|E1|Reported Event|Placebo|
661173|NCT01151215|B4|Baseline|Total|Total of all reporting groups
661174|NCT01151215|B3|Baseline|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
661175|NCT01151215|B2|Baseline|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
661176|NCT01151215|B1|Baseline|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
661177|NCT01151215|P3|Participant Flow|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
661178|NCT01151215|P2|Participant Flow|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
661179|NCT01151215|P1|Participant Flow|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
661180|NCT01151215|O3|Outcome|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
661181|NCT01151215|O2|Outcome|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
661182|NCT01151215|O1|Outcome|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
661183|NCT01151215|O3|Outcome|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
661184|NCT01151215|O2|Outcome|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
661185|NCT01151215|O1|Outcome|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
661186|NCT01151215|E3|Reported Event|Placebo|
661187|NCT01151215|E2|Reported Event|AZD8931 40mg|
661188|NCT01151215|E1|Reported Event|AZD8931 20mg|
661224|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661189|NCT01151280|B1|Baseline|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
661190|NCT01151280|P1|Participant Flow|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
661191|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
661192|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
661193|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
661194|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
661195|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
661196|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
661197|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
661198|NCT01151280|E1|Reported Event|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
661199|NCT01151345|B1|Baseline|Entire Study Population|Includes groups randomized to receive any treatment (Tilazem 60 mg tablet first or Angiotrofin 60 mg tablet first )
661200|NCT01151345|P2|Participant Flow|Angiotrofin 60 mg Then Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Tilazem®) in second intervention period after 7 day clearance period.The total study duration was 9 days.
661201|NCT01151345|P1|Participant Flow|Tilazem 60 mg Then Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in second intervention period after 7 day clearance period. The total study duration was 9 days.
661202|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
661203|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
661204|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
661205|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
661206|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
661207|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
661208|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
661209|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
661210|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
661211|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
661212|NCT01151345|E2|Reported Event|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
661213|NCT01151345|E1|Reported Event|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
661214|NCT01151371|B4|Baseline|Total|Total of all reporting groups
661215|NCT01151371|B3|Baseline|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
661216|NCT01151371|B2|Baseline|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
661217|NCT01151371|B1|Baseline|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661218|NCT01151371|P3|Participant Flow|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
661219|NCT01151371|P2|Participant Flow|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
661220|NCT01151371|P1|Participant Flow|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661221|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
661222|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661223|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
662093|NCT01161329|O1|Outcome|Controlgroup|Ordinary life.
661225|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
661226|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661227|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
661228|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661229|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
661230|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661231|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
661232|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661233|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
661234|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661235|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
661236|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661237|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
661238|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661239|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
661240|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661241|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
661242|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661243|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
661244|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661245|NCT01151371|E3|Reported Event|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
661246|NCT01151371|E2|Reported Event|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
661247|NCT01151371|E1|Reported Event|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
661248|NCT01151410|B3|Baseline|Total|Total of all reporting groups
661249|NCT01151410|B2|Baseline|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
661250|NCT01151410|B1|Baseline|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
661251|NCT01151410|P2|Participant Flow|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
661252|NCT01151410|P1|Participant Flow|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
661253|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
661254|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
661255|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
661256|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
661257|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
661258|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
661259|NCT01151410|E2|Reported Event|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
661260|NCT01151410|E1|Reported Event|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
661261|NCT01151436|B1|Baseline|Hyaluronic Acid|
661262|NCT01151436|P1|Participant Flow|Hyaluronic Acid|
661263|NCT01151436|O1|Outcome|Hyaluronic Acid|
661264|NCT01151436|O1|Outcome|Hyaluronic Acid|
661265|NCT01151436|O1|Outcome|Hyaluronic Acid|
661266|NCT01151436|O1|Outcome|Hyaluronic Acid|
661267|NCT01151436|O1|Outcome|Hyaluronic Acid|
661268|NCT01151436|O1|Outcome|Hyaluronic Acid|
661269|NCT01151436|O1|Outcome|Hyaluronic Acid|
661270|NCT01151436|O1|Outcome|Hyaluronic Acid|
661271|NCT01151436|O1|Outcome|Hyaluronic Acid|
661272|NCT01151436|O1|Outcome|Hyaluronic Acid|
661273|NCT01151436|O1|Outcome|Hyaluronic Acid|
661274|NCT01151436|O1|Outcome|Hyaluronic Acid|
661275|NCT01151436|O1|Outcome|Hyaluronic Acid|
661276|NCT01151436|O1|Outcome|Hyaluronic Acid|
661277|NCT01151436|O1|Outcome|Hyaluronic Acid|
661278|NCT01151436|O1|Outcome|Hyaluronic Acid|
661279|NCT01151436|O1|Outcome|Hyaluronic Acid|
661280|NCT01151436|O1|Outcome|Hyaluronic Acid|
661281|NCT01151436|O1|Outcome|Hyaluronic Acid|
661291|NCT01151449|B1|Baseline|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies"
661292|NCT01151449|P1|Participant Flow|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies"
661293|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies"
661294|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies"
661295|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies"
661296|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies"
661297|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies"
661298|NCT01151449|E1|Reported Event|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies"
661299|NCT01151553|B1|Baseline|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy
CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
661300|NCT01151553|P1|Participant Flow|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy
CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
661301|NCT01151553|O1|Outcome|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy
CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
661302|NCT01151553|E1|Reported Event|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy
CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
661303|NCT01151579|B3|Baseline|Total|Total of all reporting groups
661304|NCT01151579|B2|Baseline|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
661305|NCT01151579|B1|Baseline|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
661306|NCT01151579|P2|Participant Flow|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
661307|NCT01151579|P1|Participant Flow|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
661308|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
661309|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
661310|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
661311|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
661312|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
661313|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
661314|NCT01151579|E2|Reported Event|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
661315|NCT01151579|E1|Reported Event|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
661316|NCT01157234|B3|Baseline|Total|Total of all reporting groups
661317|NCT01157234|B2|Baseline|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661318|NCT01157234|B1|Baseline|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661319|NCT01157234|P2|Participant Flow|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661320|NCT01157234|P1|Participant Flow|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661321|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661322|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661323|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661324|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661325|NCT01157234|O2|Outcome|Metoprolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661326|NCT01157234|O1|Outcome|Nebivolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661327|NCT01157234|O2|Outcome|Metoprolol <50 Years Old|Hypertensive kidney transplant recipients age less than 50 years treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661328|NCT01157234|O1|Outcome|Nebivolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661329|NCT01157234|O2|Outcome|Metoprolol <50 Years Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661330|NCT01157234|O1|Outcome|Nebivolol < 50 Years Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661331|NCT01157234|O2|Outcome|Metoprolol >/= 50 Year Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
661332|NCT01157234|O1|Outcome|Nebivolol <50 Year Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
661333|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661334|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661335|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661336|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661337|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661338|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661339|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661340|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661341|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661342|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661343|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661344|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661345|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661592|NCT01159431|O2|Outcome|Control Group-Double Blind Period|Sham Treatment
661346|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
661347|NCT01157234|E2|Reported Event|Metoprolol|"Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Metoprolol: Metoprolol 25 mg twice daily, titrated to a maximum total daily dose of 400 mg to achieve a blood pressure < 140/90."
661348|NCT01157234|E1|Reported Event|Nebivolol|"Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Nebivolol: Nebivolol 5 mg once daily, titrated to a maximum total daily dose of 40 mg to achieve a blood pressure of < 140/ 90."
661349|NCT01157351|B3|Baseline|Total|Total of all reporting groups
661350|NCT01157351|B2|Baseline|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
661351|NCT01157351|B1|Baseline|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
661352|NCT01157351|P2|Participant Flow|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
661353|NCT01157351|P1|Participant Flow|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
661354|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
661355|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
661356|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
661357|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
661358|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
661359|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
661360|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
661361|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
661362|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
661363|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
662094|NCT01161329|O2|Outcome|Intervention Group|High Intensity Functional Exercise Program
661364|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
661365|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
661366|NCT01157351|E2|Reported Event|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
661367|NCT01157351|E1|Reported Event|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
661368|NCT01157377|B8|Baseline|Total|Total of all reporting groups
661369|NCT01157377|B7|Baseline|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
661370|NCT01157377|B6|Baseline|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
661371|NCT01157377|B5|Baseline|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
661372|NCT01157377|B4|Baseline|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
661373|NCT01157377|B3|Baseline|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
661374|NCT01157377|B2|Baseline|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
661375|NCT01157377|B1|Baseline|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
661376|NCT01157377|P7|Participant Flow|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
661377|NCT01157377|P6|Participant Flow|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
661378|NCT01157377|P5|Participant Flow|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
661379|NCT01157377|P4|Participant Flow|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
661380|NCT01157377|P3|Participant Flow|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
661381|NCT01157377|P2|Participant Flow|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
661382|NCT01157377|P1|Participant Flow|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
661383|NCT01157377|O7|Outcome|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
661384|NCT01157377|O6|Outcome|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
661385|NCT01157377|O5|Outcome|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
661386|NCT01157377|O4|Outcome|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
661387|NCT01157377|O3|Outcome|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
661388|NCT01157377|O2|Outcome|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
661389|NCT01157377|O1|Outcome|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
661390|NCT01157377|E7|Reported Event|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
661391|NCT01157377|E6|Reported Event|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
661392|NCT01157377|E5|Reported Event|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
661393|NCT01157377|E4|Reported Event|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
661394|NCT01157377|E3|Reported Event|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
661395|NCT01157377|E2|Reported Event|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
661396|NCT01157377|E1|Reported Event|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
661397|NCT01157416|B3|Baseline|Total|Total of all reporting groups
661398|NCT01157416|B2|Baseline|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661399|NCT01157416|B1|Baseline|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661400|NCT01157416|P2|Participant Flow|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661401|NCT01157416|P1|Participant Flow|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661402|NCT01157416|O2|Outcome|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661403|NCT01157416|O1|Outcome|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661404|NCT01157416|E2|Reported Event|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661405|NCT01157416|E1|Reported Event|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661406|NCT01157429|B3|Baseline|Total|Total of all reporting groups
661407|NCT01157429|B2|Baseline|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661408|NCT01157429|B1|Baseline|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661409|NCT01157429|P2|Participant Flow|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661410|NCT01157429|P1|Participant Flow|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661411|NCT01157429|O2|Outcome|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol."
661412|NCT01157429|O1|Outcome|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661413|NCT01157429|E2|Reported Event|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo pill: Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol."
661593|NCT01159431|O1|Outcome|Control Group-Baseline|Baseline
661414|NCT01157429|E1|Reported Event|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
661415|NCT01157533|B1|Baseline|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
661416|NCT01157533|P1|Participant Flow|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
661417|NCT01157533|O1|Outcome|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
661418|NCT01157533|E1|Reported Event|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
661419|NCT01157845|B1|Baseline|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
661420|NCT01157845|P1|Participant Flow|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
661421|NCT01157845|O1|Outcome|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
661422|NCT01157845|O1|Outcome|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
661423|NCT01157845|E1|Reported Event|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
661424|NCT01158118|B3|Baseline|Total|Total of all reporting groups
661425|NCT01158118|B2|Baseline|Arm 2 - Recipient|"Conditioning Regimens
fludarabine and busulfan +/- thymoglobulin
fractionated total body irradiation and cyclophosphamide
busulfan and cyclophosphamide
single dose total body irradiation and cyclophosphamide
Day -2 = GvHD prophylaxis
Day 0 or +1 = PBSC transplant
Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
661426|NCT01158118|B1|Baseline|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)
Day 5: Mobilization with 320 mcg/kg plerixafor IV
Day 5: Leukopheresis
If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
661427|NCT01158118|P2|Participant Flow|Arm 2 - Recipient|"Conditioning Regimens
fludarabine and busulfan +/- thymoglobulin
fractionated total body irradiation and cyclophosphamide
busulfan and cyclophosphamide
single dose total body irradiation and cyclophosphamide
Day -2 = GvHD prophylaxis
Day 0 or +1 = PBSC transplant
Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
661428|NCT01158118|P1|Participant Flow|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)
Day 5: Mobilization with 320 mcg/kg plerixafor IV
Day 5: Leukopheresis
If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
661429|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens
fludarabine and busulfan +/- thymoglobulin
fractionated total body irradiation and cyclophosphamide
busulfan and cyclophosphamide
single dose total body irradiation and cyclophosphamide
Day -2 = GvHD prophylaxis
Day 0 or +1 = PBSC transplant
Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
661430|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens
fludarabine and busulfan +/- thymoglobulin
fractionated total body irradiation and cyclophosphamide
busulfan and cyclophosphamide
single dose total body irradiation and cyclophosphamide
Day -2 = GvHD prophylaxis
Day 0 or +1 = PBSC transplant
Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
661451|NCT01158378|P1|Participant Flow|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
661452|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
661431|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens
fludarabine and busulfan +/- thymoglobulin
fractionated total body irradiation and cyclophosphamide
busulfan and cyclophosphamide
single dose total body irradiation and cyclophosphamide
Day -2 = GvHD prophylaxis
Day 0 or +1 = PBSC transplant
Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
661432|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens
fludarabine and busulfan +/- thymoglobulin
fractionated total body irradiation and cyclophosphamide
busulfan and cyclophosphamide
single dose total body irradiation and cyclophosphamide
Day -2 = GvHD prophylaxis
Day 0 or +1 = PBSC transplant
Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
661433|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens
fludarabine and busulfan +/- thymoglobulin
fractionated total body irradiation and cyclophosphamide
busulfan and cyclophosphamide
single dose total body irradiation and cyclophosphamide
Day -2 = GvHD prophylaxis
Day 0 or +1 = PBSC transplant
Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
661434|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens
fludarabine and busulfan +/- thymoglobulin
fractionated total body irradiation and cyclophosphamide
busulfan and cyclophosphamide
single dose total body irradiation and cyclophosphamide
Day -2 = GvHD prophylaxis
Day 0 or +1 = PBSC transplant
Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
661435|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens
fludarabine and busulfan +/- thymoglobulin
fractionated total body irradiation and cyclophosphamide
busulfan and cyclophosphamide
single dose total body irradiation and cyclophosphamide
Day -2 = GvHD prophylaxis
Day 0 or +1 = PBSC transplant
Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
661436|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens
fludarabine and busulfan +/- thymoglobulin
fractionated total body irradiation and cyclophosphamide
busulfan and cyclophosphamide
single dose total body irradiation and cyclophosphamide
Day -2 = GvHD prophylaxis
Day 0 or +1 = PBSC transplant
Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
661437|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)
Day 5: Mobilization with 320 mcg/kg plerixafor IV
Day 5: Leukopheresis
If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
661438|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)
Day 5: Mobilization with 320 mcg/kg plerixafor IV
Day 5: Leukopheresis
If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
661439|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)
Day 5: Mobilization with 320 mcg/kg plerixafor IV
Day 5: Leukopheresis
If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
661440|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)
Day 5: Mobilization with 320 mcg/kg plerixafor IV
Day 5: Leukopheresis
If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
661441|NCT01158118|E2|Reported Event|Arm 2 - Recipient|"Conditioning Regimens
fludarabine and busulfan +/- thymoglobulin
fractionated total body irradiation and cyclophosphamide
busulfan and cyclophosphamide
single dose total body irradiation and cyclophosphamide
Day -2 = GvHD prophylaxis
Day 0 or +1 = PBSC transplant
Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
661442|NCT01158118|E1|Reported Event|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)
Day 5: Mobilization with 320 mcg/kg plerixafor IV
Day 5: Leukopheresis
If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
661443|NCT01158261|B1|Baseline|EVICEL® Fibrin Sealant (Human)|All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
661444|NCT01158261|P1|Participant Flow|EVICEL® Fibrin Sealant (Human)|All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
661445|NCT01158261|O1|Outcome|EVICEL® Fibrin Sealant (Human)|
661446|NCT01158261|E1|Reported Event|EVICEL® Fibrin Sealant (Human)|"An adverse event (AE) was defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of the EVICEL® product. For the purpose of this protocol, an AE was any untoward medical occurrence in a study subject that may be related or possibly related to the EVICEL® product. The relatedness to EVICEL® was based on the investigator’s assessment.
In the original version of the protocol, the SAE definition did not require that the AE be related or possibly related to the treatment. This discrepancy with the AE definition resulted in the sites reporting non-EVICEL® related AEs and SAEs prior to the amended protocol implementation."
661447|NCT01158378|B3|Baseline|Total|Total of all reporting groups
661448|NCT01158378|B2|Baseline|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
661449|NCT01158378|B1|Baseline|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
661450|NCT01158378|P2|Participant Flow|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
662095|NCT01161329|O1|Outcome|Controlgroup|Ordinary life.
661454|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
661455|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
661456|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
661457|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
661458|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
661459|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
661460|NCT01158378|E2|Reported Event|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
661461|NCT01158378|E1|Reported Event|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
661462|NCT01158534|B1|Baseline|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
661463|NCT01158534|P1|Participant Flow|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
661464|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
661465|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
661466|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
661467|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
661468|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
661469|NCT01158534|E1|Reported Event|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
661470|NCT01158703|B3|Baseline|Total|Total of all reporting groups
661471|NCT01158703|B2|Baseline|Sugar Pill|"aspirin and placebo
sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
661472|NCT01158703|B1|Baseline|Clopidogrel|"aspirin and clopidogrel
clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
661473|NCT01158703|P2|Participant Flow|Sugar Pill|"aspirin and placebo
sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
661474|NCT01158703|P1|Participant Flow|Clopidogrel|"aspirin and clopidogrel
clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
661475|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo
sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
661476|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel
clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
661477|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo
sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
661478|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel
clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
661479|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo
sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
661480|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel
clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
661481|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo
sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
661482|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel
clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
661483|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo
sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
661484|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel
clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
661485|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo
sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
661486|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel
clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
661487|NCT01158703|E2|Reported Event|Sugar Pill|"aspirin and placebo
sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
661488|NCT01158703|E1|Reported Event|Clopidogrel|"aspirin and clopidogrel
clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
661489|NCT01158716|B3|Baseline|Total|Total of all reporting groups
661490|NCT01158716|B2|Baseline|Control|
661491|NCT01158716|B1|Baseline|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
661492|NCT01158716|P2|Participant Flow|Control|
661493|NCT01158716|P1|Participant Flow|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
661494|NCT01158716|O2|Outcome|Control|
661495|NCT01158716|O1|Outcome|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
661496|NCT01158716|E2|Reported Event|Control|
661497|NCT01158716|E1|Reported Event|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
661498|NCT01158924|B3|Baseline|Total|Total of all reporting groups
661499|NCT01158924|B2|Baseline|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661500|NCT01158924|B1|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661501|NCT01158924|P2|Participant Flow|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661502|NCT01158924|P1|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661554|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661503|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661504|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661505|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661506|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661507|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661508|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661509|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661510|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661511|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661512|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661513|NCT01158924|E2|Reported Event|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661514|NCT01158924|E1|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
661626|NCT01159600|P8|Participant Flow|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661515|NCT01159054|B1|Baseline|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661516|NCT01159054|P1|Participant Flow|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661517|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661531|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661580|NCT01159431|B2|Baseline|Control|Trigeminal Nerve Stimulation-Low Settings
661581|NCT01159431|B1|Baseline|Active|Trigeminal Nerve Stimulation-High Settings
661518|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661519|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661520|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661521|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661522|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661523|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661524|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661544|NCT01159262|B2|Baseline|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661525|NCT01159054|O1|Outcome|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661526|NCT01159054|E1|Reported Event|Treatment Group (One Arm Only Study)|"Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks."
661527|NCT01159171|B1|Baseline|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661528|NCT01159171|P1|Participant Flow|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1 and 15; oxaliplatin 40 mg per square meter (mg/m^2) IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661529|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661530|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661532|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661533|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661534|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661535|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661536|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Cycle 1 (28-Day Cycle) Participants received 5 milligrams/kilograms (mg/kg) bevacizumab intravenously (IV) on Days 1 and 15; 40 mg/meter^2 (mg/m^2) oxaliplatin IV on Days 1, 8, 15, and 22; and 2000 mg/m^2 capecitabine orally (PO) in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14 followed by a rest period on Days 15 through 28. Cycle 1 was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661537|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661538|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661539|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661540|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661541|NCT01159171|E1|Reported Event|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
661542|NCT01159262|B4|Baseline|Total|Total of all reporting groups
661543|NCT01159262|B3|Baseline|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661625|NCT01159600|B1|Baseline|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
661545|NCT01159262|B1|Baseline|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661546|NCT01159262|P3|Participant Flow|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661547|NCT01159262|P2|Participant Flow|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661548|NCT01159262|P1|Participant Flow|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661549|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661550|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661551|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661552|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661553|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661555|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661556|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661557|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661558|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661559|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661560|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661561|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661562|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661563|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661564|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661565|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661566|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661567|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661568|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661569|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661570|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661571|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661572|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661573|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661574|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661575|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661576|NCT01159262|E3|Reported Event|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661577|NCT01159262|E2|Reported Event|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661578|NCT01159262|E1|Reported Event|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Midazolam: Per package insert, N-PASS scores and investigator discretion
Fentanyl: Per package insert, N-PASS scores and investigator discretion.
Dexmedetomidine"
661579|NCT01159431|B3|Baseline|Total|Total of all reporting groups
661594|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
661595|NCT01159431|O1|Outcome|Treatment|Trigeminal Nerve Stimulation-High Settings
661596|NCT01159431|E2|Reported Event|Control|Trigeminal Nerve Stimulation-Low Settings
661597|NCT01159431|E1|Reported Event|Active|Trigeminal Nerve Stimulation-High Settings
661598|NCT01159535|B4|Baseline|Total|Total of all reporting groups
661599|NCT01159535|B3|Baseline|Treatment as Usual|"All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.
Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis."
661600|NCT01159535|B2|Baseline|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.
Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
661601|NCT01159535|B1|Baseline|Mindfulness Based Relapse Prevention (MBRP)|Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
661602|NCT01159535|P3|Participant Flow|Treatment as Usual (TAU)|"All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.
Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis."
661603|NCT01159535|P2|Participant Flow|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.
Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
661604|NCT01159535|P1|Participant Flow|Mindfulness Based Relapse Prevention (MBRP)|"Mindfulness Based Relapse Prevention
Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments."
661605|NCT01159535|O3|Outcome|Treatment as Usual (TAU)|Treatment as Usual included continuing care services (including attendance at Alcoholics Anonymous, Narcotics Anonymous, or other self-help groups) as recommended by their treatment providers.
661606|NCT01159535|O2|Outcome|Relapse Prevention (RP)|The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.
661607|NCT01159535|O1|Outcome|Mindfulness Based Relapse Prevention (MBRP)|"Mindfulness Based Relapse Prevention
Mindfulness Based Relapse Prevention: The MBRP intervention consisted of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments."
661608|NCT01159535|E3|Reported Event|Treatment as Usual (TAU)|Treatment as Usual participants were enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants received ongoing support and monitoring by their continuing care providers on a regular basis.
661609|NCT01159535|E2|Reported Event|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions were team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.
Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
661610|NCT01159535|E1|Reported Event|Mindfulness-Based Relapse Prevention (MBRP)|Mindfulness Based Relapse Prevention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
661611|NCT01159574|B1|Baseline|All Patients|"ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
661638|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661612|NCT01159574|P1|Participant Flow|All Patients|"ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
661613|NCT01159574|O1|Outcome|All Patients|"ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
661614|NCT01159574|O1|Outcome|All Patients|"ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
661615|NCT01159574|O1|Outcome|All Patients|"ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
661616|NCT01159574|E1|Reported Event|All Patients|"ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
661617|NCT01159600|B9|Baseline|Total|Total of all reporting groups
661618|NCT01159600|B8|Baseline|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661619|NCT01159600|B7|Baseline|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661620|NCT01159600|B6|Baseline|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661621|NCT01159600|B5|Baseline|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661622|NCT01159600|B4|Baseline|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661623|NCT01159600|B3|Baseline|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661624|NCT01159600|B2|Baseline|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
662096|NCT01161329|E2|Reported Event|Intervention Group|High Intensity Functional Exercise Program
661627|NCT01159600|P7|Participant Flow|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661628|NCT01159600|P6|Participant Flow|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661629|NCT01159600|P5|Participant Flow|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661630|NCT01159600|P4|Participant Flow|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661631|NCT01159600|P3|Participant Flow|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661632|NCT01159600|P2|Participant Flow|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
661633|NCT01159600|P1|Participant Flow|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
661634|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661635|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661636|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661637|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661639|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661640|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
661641|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
661642|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661643|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661644|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661645|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661646|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661647|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661648|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
661649|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks, in patients with background medication of metformin only.
661650|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661651|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661652|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661653|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661654|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661655|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661656|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
661657|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
661658|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661659|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661660|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661661|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661704|NCT01159665|E1|Reported Event|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
661662|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661663|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661664|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
661665|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
661666|NCT01159600|E8|Reported Event|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661667|NCT01159600|E7|Reported Event|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661668|NCT01159600|E6|Reported Event|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661669|NCT01159600|E5|Reported Event|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
661670|NCT01159600|E4|Reported Event|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661671|NCT01159600|E3|Reported Event|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
661672|NCT01159600|E2|Reported Event|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
661673|NCT01159600|E1|Reported Event|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
661675|NCT01159665|B6|Baseline|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
661676|NCT01159665|B5|Baseline|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
661677|NCT01159665|B4|Baseline|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
661678|NCT01159665|B3|Baseline|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
661679|NCT01159665|B2|Baseline|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
661680|NCT01159665|B1|Baseline|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
661681|NCT01159665|P6|Participant Flow|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
661682|NCT01159665|P5|Participant Flow|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
661683|NCT01159665|P4|Participant Flow|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
661684|NCT01159665|P3|Participant Flow|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
661685|NCT01159665|P2|Participant Flow|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
661686|NCT01159665|P1|Participant Flow|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
661687|NCT01159665|O6|Outcome|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
661688|NCT01159665|O5|Outcome|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
661689|NCT01159665|O4|Outcome|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
661690|NCT01159665|O3|Outcome|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
661691|NCT01159665|O2|Outcome|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
661692|NCT01159665|O1|Outcome|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
661693|NCT01159665|O6|Outcome|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
661694|NCT01159665|O5|Outcome|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
661695|NCT01159665|O4|Outcome|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
661696|NCT01159665|O3|Outcome|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
661697|NCT01159665|O2|Outcome|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
661698|NCT01159665|O1|Outcome|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
661699|NCT01159665|E6|Reported Event|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
661700|NCT01159665|E5|Reported Event|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
661701|NCT01159665|E4|Reported Event|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
661702|NCT01159665|E3|Reported Event|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
661703|NCT01159665|E2|Reported Event|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
662097|NCT01161329|E1|Reported Event|Controlgroup|Ordinary life.
661705|NCT01159691|B1|Baseline|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
661706|NCT01159691|P1|Participant Flow|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
661707|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
661708|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
661709|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
661710|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
661711|NCT01159691|E1|Reported Event|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
661712|NCT01159743|B3|Baseline|Total|Total of all reporting groups
661713|NCT01159743|B2|Baseline|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661714|NCT01159743|B1|Baseline|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661715|NCT01159743|P2|Participant Flow|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661716|NCT01159743|P1|Participant Flow|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661717|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661718|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661719|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661720|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661721|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661722|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661723|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661724|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661725|NCT01159743|E2|Reported Event|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661726|NCT01159743|E1|Reported Event|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
661727|NCT01159769|B1|Baseline|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
661728|NCT01159769|P1|Participant Flow|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
661729|NCT01159769|O1|Outcome|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
661730|NCT01159769|O1|Outcome|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
661731|NCT01159769|E1|Reported Event|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
661732|NCT01159912|B4|Baseline|Total|Total of all reporting groups
661733|NCT01159912|B3|Baseline|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661734|NCT01159912|B2|Baseline|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661735|NCT01159912|B1|Baseline|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
662098|NCT01161407|B3|Baseline|Total|Total of all reporting groups
661736|NCT01159912|P3|Participant Flow|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661737|NCT01159912|P2|Participant Flow|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661738|NCT01159912|P1|Participant Flow|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661739|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661740|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661741|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661742|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661743|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661744|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661745|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661746|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661747|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661748|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661749|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661750|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661751|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661752|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661753|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661754|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661755|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661756|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661864|NCT01154452|O4|Outcome|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
661757|NCT01159912|E3|Reported Event|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661758|NCT01159912|E2|Reported Event|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661759|NCT01159912|E1|Reported Event|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
661760|NCT01159938|B4|Baseline|Total|Total of all reporting groups
661761|NCT01159938|B3|Baseline|T2DM With Normal UAER|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
661762|NCT01159938|B2|Baseline|T2DM With Albuminuria|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
661763|NCT01159938|B1|Baseline|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661764|NCT01159938|P5|Participant Flow|T2DM With Normal UAER, Low to High|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661765|NCT01159938|P4|Participant Flow|T2DM With Normal UAER, High to Low|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661766|NCT01159938|P3|Participant Flow|T2DM With Albuminuria, Low to High|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661767|NCT01159938|P2|Participant Flow|T2DM With Albuminuria, High to Low|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661768|NCT01159938|P1|Participant Flow|Healthy Participants|Healthy participants with normal glucose tolerance and normal UAER did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661769|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661770|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661771|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661772|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661865|NCT01154452|O3|Outcome|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
661866|NCT01154452|O2|Outcome|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
661773|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661774|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661775|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661776|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661777|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661778|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams albumin per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661833|NCT01160237|P1|Participant Flow|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
661779|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose
661780|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661781|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661782|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661783|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661784|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661785|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661786|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661787|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661788|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661789|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661790|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661791|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661792|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661793|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661794|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661795|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661796|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661797|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661798|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661799|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661800|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661801|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661802|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661803|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661804|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661805|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661806|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661867|NCT01154452|O1|Outcome|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
661868|NCT01154452|O1|Outcome|All Phase Ib Participants|All Phase Ib Participants
661807|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661808|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661809|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661810|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661811|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661812|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661813|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661834|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
661835|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
661814|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661815|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661816|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661817|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661818|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661819|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661820|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661821|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
661822|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
661869|NCT01154452|E4|Reported Event|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
661870|NCT01154452|E3|Reported Event|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
661871|NCT01154452|E2|Reported Event|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
661872|NCT01154452|E1|Reported Event|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
661823|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661824|NCT01159938|E3|Reported Event|T2DM With Normal UAER|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
661825|NCT01159938|E2|Reported Event|T2DM With Albuminuria|T2DM participants with abnormal UAER [albuminuria(defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
661826|NCT01159938|E1|Reported Event|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
661827|NCT01160237|B4|Baseline|Total|Total of all reporting groups
661828|NCT01160237|B3|Baseline|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
661829|NCT01160237|B2|Baseline|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
661830|NCT01160237|B1|Baseline|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
661831|NCT01160237|P3|Participant Flow|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
661832|NCT01160237|P2|Participant Flow|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
662109|NCT01161407|E2|Reported Event|Calcium|
661836|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
661837|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
661838|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
661839|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
661840|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
661841|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
661842|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
661843|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
661844|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
661845|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
661846|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
661847|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
661848|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
661849|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
661850|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
661851|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
661852|NCT01160237|E3|Reported Event|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
661853|NCT01160237|E2|Reported Event|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
661854|NCT01160237|E1|Reported Event|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
661855|NCT01154452|B5|Baseline|Total|Total of all reporting groups
661856|NCT01154452|B4|Baseline|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
661857|NCT01154452|B3|Baseline|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
661858|NCT01154452|B2|Baseline|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
661859|NCT01154452|B1|Baseline|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
661860|NCT01154452|P4|Participant Flow|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
661861|NCT01154452|P3|Participant Flow|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
661862|NCT01154452|P2|Participant Flow|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
661863|NCT01154452|P1|Participant Flow|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
661873|NCT01154634|B5|Baseline|Total|Total of all reporting groups
661874|NCT01154634|B4|Baseline|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
661875|NCT01154634|B3|Baseline|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
661876|NCT01154634|B2|Baseline|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
661877|NCT01154634|B1|Baseline|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
661878|NCT01154634|P4|Participant Flow|First Placebo, Then 40 mg, Then 5 mg, Then 16 mg|period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg
661879|NCT01154634|P3|Participant Flow|First 16 mg, Then 5 mg, Then 40 mg, Then Placebo|period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo.
661880|NCT01154634|P2|Participant Flow|First 40 mg, Then 16 mg, Then Placebo, Then 5 mg|period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg.
661881|NCT01154634|P1|Participant Flow|First 5 mg, Then Placebo, Then 16 mg, Then 40 mg|period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg.
661882|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
661883|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
661884|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
662110|NCT01161407|E1|Reported Event|Placebo|
661885|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
661886|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
661887|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
661888|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
661889|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
661890|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
661891|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
661892|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
661893|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
661894|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
661895|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
661896|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
661897|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
661898|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
661899|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
661900|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
661901|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
661902|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
661903|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
661904|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
661905|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
661906|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
661907|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
661908|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
661909|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
661910|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
661911|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
661912|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
661913|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
661914|NCT01154634|E4|Reported Event|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
661915|NCT01154634|E3|Reported Event|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
661916|NCT01154634|E2|Reported Event|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
661917|NCT01154634|E1|Reported Event|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
661918|NCT01154673|B3|Baseline|Total|Total of all reporting groups
661919|NCT01154673|B2|Baseline|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
661920|NCT01154673|B1|Baseline|Intensive HAART|"Patients in this arm will receive the following HAART regimen:
Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
661921|NCT01154673|P2|Participant Flow|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID) and endpoint is measured at 48 weeks
661922|NCT01154673|P1|Participant Flow|Intensive HAART|"Patients in this arm will receive the following HAART regimen:
Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID and endpoint is measured at 48 weeks"
661923|NCT01154673|O2|Outcome|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
661924|NCT01154673|O1|Outcome|Intensive HAART|"Patients in this arm will receive the following HAART regimen:
Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
661925|NCT01154673|E2|Reported Event|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
661926|NCT01154673|E1|Reported Event|Intensive HAART|"Patients in this arm will receive the following HAART regimen:
Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
661927|NCT01154699|B3|Baseline|Total|Total of all reporting groups
661928|NCT01154699|B2|Baseline|Asthma + OSA|Subjects meeting all inclusion criteria and no exclusion criteria with asthma and obstructive sleep apnea on continuous positive airway pressure (CPAP) treatment
661929|NCT01154699|B1|Baseline|Asthma Only|Subjects meeting all inclusion criteria and no exclusion criteria with asthma only (no sleep apnea)
661930|NCT01154699|P2|Participant Flow|Bilevel PAP First, Then Usual Care|"Subjects will begin the study by starting on Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests. After a 4 week Washout Period of usual care, they will start a Usual Care period for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period."
661931|NCT01154699|P1|Participant Flow|Usual Care First, Then Bilevel PAP|"Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period. After a Washout Period of an additional 4 weeks of usual care, they will then start Bilevel PAP therapy for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests."
661932|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.
Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
661933|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
661934|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.
Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
661935|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
661936|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.
Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
661937|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
661938|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.
Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
661939|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
661940|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.
Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
661941|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
661942|NCT01154699|O2|Outcome|Bilevel PAP|Subjects will wear Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.
661943|NCT01154699|O1|Outcome|Usual Care|Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.
661944|NCT01154699|E2|Reported Event|Asthma + OSA|Subjects meeting all inclusion criteria and no exclusion criteria with asthma and obstructive sleep apnea on continuous positive airway pressure (CPAP) treatment
661945|NCT01154699|E1|Reported Event|Asthma Only|Subjects meeting all inclusion criteria and no exclusion criteria with asthma only (no sleep apnea)
661946|NCT01154751|B1|Baseline|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661947|NCT01154751|P1|Participant Flow|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661948|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661949|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661950|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661951|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661952|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
662554|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
661953|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661954|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661955|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661956|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661957|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661958|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661959|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661960|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661961|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661962|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661963|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661964|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661965|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661966|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661967|NCT01154751|O1|Outcome|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661968|NCT01154751|E1|Reported Event|Device SUPERA Stent|"SUPERA Interwoven Self-Expanding Nitinol Stent System
SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area"
661969|NCT01160380|B3|Baseline|Total|Total of all reporting groups
661970|NCT01160380|B2|Baseline|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets."
661971|NCT01160380|B1|Baseline|Armodafinil|"The patients receive armodafinil for all 56 days of the study.
armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets."
661972|NCT01160380|P2|Participant Flow|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
661973|NCT01160380|P1|Participant Flow|Armodafinil|"The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily."
661974|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
661975|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily."
662060|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received multiple doses of 15 mg ORF
661976|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
661977|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily."
661978|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
661979|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily."
661980|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
661981|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily."
661982|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
661983|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily."
661984|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
661985|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily."
661986|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
661987|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily."
661988|NCT01160380|E2|Reported Event|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
AEs presented were those occurring during from Day 1 to Day 28 only"
661989|NCT01160380|E1|Reported Event|Armodafinil|"The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs)."
661990|NCT01160445|B3|Baseline|Total|Total of all reporting groups
661991|NCT01160445|B2|Baseline|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
661992|NCT01160445|B1|Baseline|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
661993|NCT01160445|P2|Participant Flow|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
661994|NCT01160445|P1|Participant Flow|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
661995|NCT01160445|O2|Outcome|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
661996|NCT01160445|O1|Outcome|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
661997|NCT01160445|O2|Outcome|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
661998|NCT01160445|O1|Outcome|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
661999|NCT01160445|E2|Reported Event|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
662000|NCT01160445|E1|Reported Event|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
662001|NCT01160458|B1|Baseline|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
662002|NCT01160458|P1|Participant Flow|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
662003|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
662004|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
662005|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
662006|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
662061|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received multiple doses of 10 mg ORF
662007|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
662008|NCT01160458|E1|Reported Event|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
662009|NCT01160484|B1|Baseline|DVD-R Single Arm|"Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin + Lenalidomide (DVD-R) Therapy:
Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:
1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14"
662010|NCT01160484|P1|Participant Flow|DVD-R Single Arm|"Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin (PLD)+ Lenalidomide (DVD-R) Therapy:
Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:
1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14"
662011|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
662158|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662012|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
662013|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
662014|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
662015|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
662016|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
662017|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
662056|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
662057|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 15 mg ORF
662058|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 10 mg ORF
662018|NCT01160484|E1|Reported Event|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
662019|NCT01160614|B3|Baseline|Total|Total of all reporting groups
662020|NCT01160614|B2|Baseline|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
662021|NCT01160614|B1|Baseline|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
662022|NCT01160614|P2|Participant Flow|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
662023|NCT01160614|P1|Participant Flow|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
662024|NCT01160614|O2|Outcome|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
662025|NCT01160614|O1|Outcome|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
662026|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
662027|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
662028|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
662029|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
662030|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
662031|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
662032|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
662033|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
662034|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
662035|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
662036|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
662037|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
662038|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
662039|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
662040|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
662041|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
662042|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
662043|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
662044|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
662045|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
662046|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
662047|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
662048|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
662049|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
662050|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
662051|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
662052|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
662053|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
662054|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
662055|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
662059|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received multiple doses of 20 mg ORF
662062|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
662063|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
662064|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
662065|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
662066|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
662067|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
662068|NCT01160614|E2|Reported Event|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
662069|NCT01160614|E1|Reported Event|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
662070|NCT01160640|B3|Baseline|Total|Total of all reporting groups
662071|NCT01160640|B2|Baseline|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
662072|NCT01160640|B1|Baseline|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
662156|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662073|NCT01160640|P2|Participant Flow|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
662074|NCT01160640|P1|Participant Flow|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
662075|NCT01160640|O2|Outcome|Histological Endometritis Absent|Women who did not have endometritis confirmed by histologic assessment for endometritis
662076|NCT01160640|O1|Outcome|Histological Endometritis Present|Women who had endometritis confirmed by histologic assessment for endometritis. Endometritis was defined as >1 plasma cell per 100X microscopic field, was assessed independently by 2 pathologists blinded to the design
662077|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
662078|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
662079|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
662080|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
662081|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
662082|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
662083|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
662084|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
662085|NCT01160640|E2|Reported Event|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days
ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
662086|NCT01160640|E1|Reported Event|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days
ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
662087|NCT01161329|B3|Baseline|Total|Total of all reporting groups
662088|NCT01161329|B2|Baseline|Intervention Group|High Intensity Functional Exercise Program
662089|NCT01161329|B1|Baseline|Controlgroup|Ordinary life.
662090|NCT01161329|P2|Participant Flow|Intervention Group|High-Intensity Functional Exercise Program (HIFE) in combination with motivational group discussions two times a week. .
662091|NCT01161329|P1|Participant Flow|Controlgroup|Instructed to live their ordinary life.
662099|NCT01161407|B2|Baseline|Placebo Then Calcium|"Crossover order was placebo then calcium, separated by at least a 3 week washout period.
Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
662100|NCT01161407|B1|Baseline|Calcium Then Placebo|"Crossover order was calcium then placebo, separated by at least a 3 week washout period.
Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
662101|NCT01161407|P2|Participant Flow|Placebo Then Calcium|"Crossover order was placebo then calcium, separated by at least a 3 week washout period.
Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
662102|NCT01161407|P1|Participant Flow|Calcium Then Placebo|"Crossover order was calcium then placebo, separated by at least a 3 week washout period.
Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
662103|NCT01161407|O2|Outcome|Calcium|
662104|NCT01161407|O1|Outcome|Placebo|
662105|NCT01161407|O2|Outcome|Calcium|
662106|NCT01161407|O1|Outcome|Placebo|
662107|NCT01161407|O2|Outcome|Calcium|
662108|NCT01161407|O1|Outcome|Placebo|
662111|NCT01161420|B1|Baseline|Inspire Therapy|"Study subjects continue to use Inspire therapy
Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration."
662112|NCT01161420|P1|Participant Flow|Inspire Therapy|126 subjects were implanted with Inspire therapy
662113|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects were implanted with Inspire therapy; 124 subjects completed this visit (two expired prior to the 12-month visit).
662114|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects completed the baseline questionnaire, however 123 study subjects completed the 12-month questionnaire; two subjects did not completed this questionnaire and one subject expired.
662115|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects completed the baseline questionnaire, however 123 study subjects completed the 12-month questionnaire; two subjects did not completed this questionnaire and one subject expired.
662116|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects implanted with Inspire therapy
662117|NCT01161420|O2|Outcome|Withdrawal|Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
662118|NCT01161420|O1|Outcome|Maintenance|Twenty-three (23) patients were in the therapy maintenance (ON) group
662119|NCT01161420|O1|Outcome|All Subjects|126 implanted study subjects
662120|NCT01161420|O1|Outcome|Inspire Therapy|Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
662121|NCT01161420|O1|Outcome|Inspire Therapy|Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
662122|NCT01161420|E1|Reported Event|Inspire Therapy|This pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.
662123|NCT01161446|B3|Baseline|Total|Total of all reporting groups
662124|NCT01161446|B2|Baseline|Standard Testing|HIV testing as usual.
662125|NCT01161446|B1|Baseline|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
662126|NCT01161446|P2|Participant Flow|Standard Testing|HIV testing as usual.
662127|NCT01161446|P1|Participant Flow|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
662128|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
662129|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
662130|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
662131|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
662132|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
662133|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
662134|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
662135|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
662136|NCT01161446|E2|Reported Event|Standard Testing|HIV testing as usual.
662137|NCT01161446|E1|Reported Event|Home Testing|"Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: The device is the home HIV self-testing kit that includes the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use on oral fluids. The kit itself is not the focus of this trial. As described in the Behavioral Intervention section, the intervention is having access to home self-testing for HIV."
662138|NCT01161472|B1|Baseline|Entire Study Population|All participants randomized to any treatment (fesoterodine 4 mg tablet first, fesoterodine 8 mg tablet first, alprazolam 1 mg capsule first and placebo first).
662157|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662139|NCT01161472|P4|Participant Flow|Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
662140|NCT01161472|P3|Participant Flow|Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
662141|NCT01161472|P2|Participant Flow|Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
662142|NCT01161472|P1|Participant Flow|Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg|Fesoterodine 4 milligram (mg) tablet administered orally once daily (OD) for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
662143|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662144|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662145|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662146|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662147|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662148|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662269|NCT01161771|E1|Reported Event|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
662149|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662150|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662151|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662152|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662153|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662154|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662155|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662286|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662159|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662160|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662161|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662162|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662163|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662164|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662165|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662166|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662167|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662168|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662169|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662170|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662171|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662172|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662173|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662174|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662175|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662176|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662177|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662178|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662270|NCT01162096|B1|Baseline|Transplantation|
662271|NCT01162096|P1|Participant Flow|Transplantation|
662272|NCT01162096|O1|Outcome|Transplantation|
662179|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662180|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662181|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662182|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662183|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662184|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662185|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662186|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662287|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662187|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662188|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662189|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662190|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662191|NCT01161472|E4|Reported Event|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662192|NCT01161472|E3|Reported Event|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662193|NCT01161472|E2|Reported Event|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662194|NCT01161472|E1|Reported Event|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
662195|NCT01161498|B3|Baseline|Total|Total of all reporting groups
662196|NCT01161498|B2|Baseline|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662197|NCT01161498|B1|Baseline|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662198|NCT01161498|P2|Participant Flow|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ plaque-forming units (PFU)/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662199|NCT01161498|P1|Participant Flow|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662200|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662201|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662202|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662273|NCT01162096|E1|Reported Event|Transplantation|
662274|NCT01162122|B3|Baseline|Total|Total of all reporting groups
662203|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662204|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662205|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662206|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662207|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662208|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662555|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662209|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662210|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662211|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662212|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662213|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662214|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662215|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662216|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662217|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662218|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662219|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662220|NCT01161498|E2|Reported Event|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
662221|NCT01161498|E1|Reported Event|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
662275|NCT01162122|B2|Baseline|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662222|NCT01161537|B1|Baseline|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.
Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
662223|NCT01161537|P1|Participant Flow|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 milligram (mg) orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.
Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
662224|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.
Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
662225|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.
Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
662246|NCT01161563|O1|Outcome|Leuprolide Acetate|Results combined for the leuprolide acetate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
662247|NCT01161563|E2|Reported Event|Triptorelin Pamoate|
662226|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.
Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
662227|NCT01161537|O1|Outcome|Part B VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study were assessed between Day 1 to Week 48 of Part B. Part B included subjects from Part A and newly enrolled subjects.
662228|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.
Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
662229|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.
Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
662230|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.
Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
662231|NCT01161537|O2|Outcome|Part A VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), during Part A of the study were assessed between Day 15 to 42 of Part A.
662232|NCT01161537|O1|Outcome|Part A Placebo Run in/Washout|Subjects who received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period) and from Day 43 to 57 (Placebo washout period) during Part A of the study were assessed between Day 1 to 14 and Day 43 to 57 of Part A.
662233|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.
Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
662234|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.
Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
662235|NCT01161537|E3|Reported Event|Part B VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study were assessed between Day 1 to Week 48 of Part B. Part B included subjects from Part A and newly enrolled subjects.
662236|NCT01161537|E2|Reported Event|Part A VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), during Part A of the study were assessed between Day 15 to 42 of Part A.
662237|NCT01161537|E1|Reported Event|Part A Placebo Run in/Washout|Subjects who received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period) and from Day 43 to 57 (Placebo washout period) during Part A of the study were assessed between Day 1 to 14 and Day 43 to 57 of Part A.
662238|NCT01161563|B3|Baseline|Total|Total of all reporting groups
662239|NCT01161563|B2|Baseline|Triptorelin First, Then Leuprolide Acetate|Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock 6 months before injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area.
662240|NCT01161563|B1|Baseline|Leuprolide Acetate First, Then Triptorelin|Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area 6 months before injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.
662241|NCT01161563|P2|Participant Flow|Leuprolide Acetate First, Then Triptorelin|"Injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area, followed 6 months later by injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.
A detailed breakdown of participant flow by treatment period for each arm is not available."
662242|NCT01161563|P1|Participant Flow|Triptorelin First, Then Leuprolide Acetate|"Injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock, followed 6 months later by injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area.
A detailed breakdown of participant flow by treatment period for each arm is not available."
662243|NCT01161563|O2|Outcome|Triptorelin Pamoate|Results combined for the triptorelin pamoate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
662244|NCT01161563|O1|Outcome|Leuprolide Acetate|Results combined for the leuprolide acetate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
662245|NCT01161563|O2|Outcome|Triptorelin Pamoate|Results combined for the triptorelin pamoate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
662249|NCT01161628|B1|Baseline|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662250|NCT01161628|P1|Participant Flow|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662251|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662252|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662253|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662254|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662255|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662256|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662257|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662258|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662259|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662260|NCT01161628|E1|Reported Event|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD
Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
662261|NCT01161771|B1|Baseline|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
662262|NCT01161771|P1|Participant Flow|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
662263|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
662264|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
662265|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
662266|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
662267|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
662268|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
662276|NCT01162122|B1|Baseline|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662277|NCT01162122|P2|Participant Flow|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662278|NCT01162122|P1|Participant Flow|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662279|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662280|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662281|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662282|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662283|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662284|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662285|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662330|NCT01162122|O2|Outcome|aTIV_Lot 2|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
662288|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662289|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662290|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662291|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662292|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662293|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662294|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662295|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662296|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662297|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662298|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662299|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662300|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662301|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662302|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662303|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662304|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662305|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662306|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662307|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662308|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662309|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662310|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662311|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662312|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662313|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662314|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662315|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662316|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662317|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662318|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662319|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662320|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662321|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662322|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662323|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662324|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662325|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662326|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662327|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662328|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662329|NCT01162122|O3|Outcome|aTIV_Lot 3|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
662331|NCT01162122|O1|Outcome|aTIV_Lot 1|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
662332|NCT01162122|E2|Reported Event|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
662333|NCT01162122|E1|Reported Event|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
662334|NCT01162135|B1|Baseline|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
662335|NCT01162135|P1|Participant Flow|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
662336|NCT01162135|O1|Outcome|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
662337|NCT01162135|E1|Reported Event|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
662338|NCT01162304|B1|Baseline|ER Oxycodone vs IR Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.
Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours
IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours
Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
662339|NCT01162304|P1|Participant Flow|ER Oxycodone vs IR Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.
Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours
IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
662340|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours
Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
662341|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.
Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
662342|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours
Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
662343|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.
Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
662344|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours
Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
662345|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.
Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
662346|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours
Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
662347|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.
Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
662384|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662348|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours
Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
662349|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.
Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
662350|NCT01162304|E2|Reported Event|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours
Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
662351|NCT01162304|E1|Reported Event|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.
Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
662352|NCT01162317|B3|Baseline|Total|Total of all reporting groups
662353|NCT01162317|B2|Baseline|Arm 2: Acupuncture|"acupuncture
Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
662478|NCT01162733|P1|Participant Flow|Study Drug 1|"Vancomycin 15mg/kg
Vancomycin : 15mg/kg"
662354|NCT01162317|B1|Baseline|Arm 1: Sham Acupuncture|"sham acupuncture
Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
662355|NCT01162317|P2|Participant Flow|Arm 2: Acupuncture|"acupuncture
Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
662356|NCT01162317|P1|Participant Flow|Arm 1: Sham Acupuncture|"sham acupuncture
Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
662357|NCT01162317|O2|Outcome|Arm 2: Acupuncture|"acupuncture
Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
662358|NCT01162317|O1|Outcome|Arm 1: Sham Acupuncture|"sham acupuncture
Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
662359|NCT01162317|O2|Outcome|Arm 2: Acupuncture|"acupuncture
Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
662360|NCT01162317|O1|Outcome|Arm 1: Sham Acupuncture|"sham acupuncture
Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
662361|NCT01162317|E2|Reported Event|Arm 2: Acupuncture|"acupuncture
Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
662362|NCT01162317|E1|Reported Event|Arm 1: Sham Acupuncture|"sham acupuncture
Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
662363|NCT01162421|B3|Baseline|Total|Total of all reporting groups
662364|NCT01162421|B2|Baseline|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662365|NCT01162421|B1|Baseline|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662479|NCT01162733|O2|Outcome|Study Drug 2|"Vancomycin 30mg/kg
Vancomycin : 30mg/kg"
662480|NCT01162733|O1|Outcome|Study Drug 1|"Vancomycin 15mg/kg
Vancomycin : 15mg/kg"
662366|NCT01162421|P2|Participant Flow|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662367|NCT01162421|P1|Participant Flow|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662368|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662369|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662370|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662371|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662372|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662373|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662374|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662375|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662376|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662377|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662378|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662379|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662380|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662381|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662382|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662383|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662537|NCT01163032|E2|Reported Event|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662385|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662386|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662387|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662388|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662389|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662390|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662391|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662392|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662393|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662394|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662395|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662396|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662397|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662398|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662399|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662400|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662401|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662402|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662403|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662404|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662405|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662406|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662407|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662408|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662409|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662410|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662411|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662412|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662413|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662414|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662415|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662416|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662417|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662418|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662419|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662420|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662421|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662422|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662423|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662424|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662425|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662426|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662427|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662428|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662429|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662430|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662431|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662432|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662433|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662434|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662435|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662436|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662437|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662438|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662439|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662440|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662441|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662442|NCT01162421|E2|Reported Event|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
662443|NCT01162421|E1|Reported Event|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
662444|NCT01162473|B3|Baseline|Total|Total of all reporting groups
662445|NCT01162473|B2|Baseline|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
662446|NCT01162473|B1|Baseline|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
662481|NCT01162733|O2|Outcome|Study Drug 2|"Vancomycin 30mg/kg
Vancomycin : 30mg/kg"
662447|NCT01162473|P2|Participant Flow|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
662448|NCT01162473|P1|Participant Flow|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
662449|NCT01162473|O2|Outcome|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
662450|NCT01162473|O1|Outcome|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
662451|NCT01162473|E2|Reported Event|Immediate Desensitization|Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder (29 week protocol)
662452|NCT01162473|E1|Reported Event|Delayed Desensitization|Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder (42 week protocol).
662453|NCT01162499|B1|Baseline|Subject Population|All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
662454|NCT01162499|P2|Participant Flow|Vehicle First, Then Exendin-(9-39)|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The next day, all procedures were repeated except subjects received an IV infusion of Exendin-(9-39) which was started 1 hour prior to the meal challenge and continued for 4 hours. The dose for the first 3 subjects was 300pmol/kg/min and, as planned, it was increased to 500pmol/kg/min for subsequent subjects.
662455|NCT01162499|P1|Participant Flow|Exendin-(9-39) First, Then Vehicle|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose for the first 3 subjects was 300pmol/kg/min and, as planned, it was increased to 500pmol/kg/min for subsequent subjects. The next day, all procedures were repeated except subjects received an IV infusion of normal saline (vehicle) over 4 hours.
662456|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
662457|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
662498|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662809|NCT01163266|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
662458|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
662459|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
662460|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
662461|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
662482|NCT01162733|O1|Outcome|Study Drug 1|"Vancomycin 15mg/kg
Vancomycin : 15mg/kg"
662483|NCT01162733|E2|Reported Event|Study Drug 2|"Vancomycin 30mg/kg
Vancomycin : 30mg/kg"
662484|NCT01162733|E1|Reported Event|Study Drug 1|"Vancomycin 15mg/kg
Vancomycin : 15mg/kg"
662485|NCT01162863|B4|Baseline|Total|Total of all reporting groups
662462|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
662463|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
662464|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
662465|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
662466|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
662467|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
662468|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
662469|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
662810|NCT01163279|B3|Baseline|Total|Total of all reporting groups
662470|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
662471|NCT01162499|E3|Reported Event|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
662472|NCT01162499|E2|Reported Event|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
662473|NCT01162499|E1|Reported Event|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
662474|NCT01162733|B3|Baseline|Total|Total of all reporting groups
662475|NCT01162733|B2|Baseline|Study Drug 2|"Vancomycin 30mg/kg
Vancomycin : 30mg/kg"
662476|NCT01162733|B1|Baseline|Study Drug 1|"Vancomycin 15mg/kg
Vancomycin : 15mg/kg"
662477|NCT01162733|P2|Participant Flow|Study Drug 2|"Vancomycin 30mg/kg
Vancomycin : 30mg/kg"
662486|NCT01162863|B3|Baseline|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662487|NCT01162863|B2|Baseline|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662488|NCT01162863|B1|Baseline|Placebo|"Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662489|NCT01162863|P3|Participant Flow|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662490|NCT01162863|P2|Participant Flow|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662491|NCT01162863|P1|Participant Flow|Placebo|"Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662492|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662493|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662494|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662495|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662496|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662497|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662536|NCT01163032|E3|Reported Event|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662499|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662500|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662501|NCT01162863|E3|Reported Event|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662502|NCT01162863|E2|Reported Event|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662503|NCT01162863|E1|Reported Event|Placebo|"Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
662504|NCT01163032|B4|Baseline|Total|Total of all reporting groups
662505|NCT01163032|B3|Baseline|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662506|NCT01163032|B2|Baseline|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662507|NCT01163032|B1|Baseline|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
663707|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
662508|NCT01163032|P3|Participant Flow|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662509|NCT01163032|P2|Participant Flow|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662510|NCT01163032|P1|Participant Flow|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662511|NCT01163032|O1|Outcome|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662512|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662513|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662514|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662515|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662516|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662517|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662518|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662519|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662520|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662521|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662522|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662523|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662524|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662525|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662526|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662527|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662528|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662529|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662530|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662531|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662532|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662533|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662534|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months
Placebo: Placebo capsules, PO daily for 6 months"
662535|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662926|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
662538|NCT01163032|E1|Reported Event|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months
tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
662539|NCT01163097|B4|Baseline|Total|Total of all reporting groups
662540|NCT01163097|B3|Baseline|Untreated Control|Treatment C: control group without any treatment administered
662541|NCT01163097|B2|Baseline|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662542|NCT01163097|B1|Baseline|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662543|NCT01163097|P3|Participant Flow|Untreated Control|Treatment C: control group without any treatment administered
662544|NCT01163097|P2|Participant Flow|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662545|NCT01163097|P1|Participant Flow|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662546|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
662547|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662548|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
662549|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662550|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
662551|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662552|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
662553|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662556|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
662557|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662558|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
662559|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662560|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
662561|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662562|NCT01163097|O3|Outcome|Untreated Control|Treatment C: control group without any treatment administered
662563|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662564|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662565|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662566|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662567|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662568|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662569|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662570|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662571|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662572|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662573|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662574|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662575|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662576|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662577|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662578|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662579|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662580|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662581|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
662582|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662583|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662584|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662585|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662586|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662587|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662588|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662589|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662590|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662591|NCT01163097|E3|Reported Event|Untreated Control|Treatment C: control group without any treatment administered
662592|NCT01163097|E2|Reported Event|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
662593|NCT01163097|E1|Reported Event|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
662594|NCT01163162|B1|Baseline|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
662595|NCT01163162|P1|Participant Flow|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
662596|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
662597|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
662598|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
662599|NCT01163162|E1|Reported Event|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
662600|NCT01163214|B3|Baseline|Total|Total of all reporting groups
662601|NCT01163214|B2|Baseline|Periarticular Injection|"Injection combination prior to skin closure.
Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
662602|NCT01163214|B1|Baseline|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
662603|NCT01163214|P2|Participant Flow|Periarticular Injection|"Injection combination prior to skin closure.
Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
662604|NCT01163214|P1|Participant Flow|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
662605|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.
Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
662606|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
662607|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.
Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
662608|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
662609|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.
Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
662610|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
662611|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.
Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
662612|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
662807|NCT01163266|E3|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
662613|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.
Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
662614|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
662615|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.
Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
662616|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
662617|NCT01163214|E2|Reported Event|Periarticular Injection|"Injection combination prior to skin closure.
Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
662618|NCT01163214|E1|Reported Event|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
662619|NCT01163253|B3|Baseline|Total|Total of all reporting groups
662887|NCT01163617|P5|Participant Flow|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
662964|NCT01163760|E4|Reported Event|Oculfilcon D / Ocufilcon D|ocufilcon D contact lenses worn first and second period.
662620|NCT01163253|B2|Baseline|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662621|NCT01163253|B1|Baseline|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662622|NCT01163253|P2|Participant Flow|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662623|NCT01163253|P1|Participant Flow|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662624|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662625|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662626|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662627|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662628|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662629|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662630|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662631|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662632|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662633|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662634|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662635|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662636|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662637|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662638|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662639|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662888|NCT01163617|P4|Participant Flow|Physiolis Autoinjector First, Then Current Autoinjector|Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
662965|NCT01163760|E3|Reported Event|Etafilcon A/ Etafilcon A|etafilcon A contact lenses worn first and second period.
662640|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662641|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662642|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662643|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662644|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662645|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662646|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662647|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662648|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662649|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662650|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662651|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662652|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662653|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662654|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662655|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662656|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662657|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662658|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662659|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662876|NCT01163604|B1|Baseline|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.
Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
662660|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662661|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662662|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662663|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662664|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662665|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662666|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662667|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662668|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662669|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662670|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662671|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662672|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662673|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662674|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662675|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662676|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662677|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662678|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662679|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662877|NCT01163604|P2|Participant Flow|"Aspirin and Clopidogrel Interventions Group"|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
662680|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662681|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662682|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662683|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662684|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662685|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662686|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662687|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662688|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662689|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662690|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662691|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662692|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662693|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662694|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662695|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662696|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662697|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662698|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662699|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662878|NCT01163604|P1|Participant Flow|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.
Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
662700|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662701|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662702|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662703|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662704|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662705|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662706|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662707|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662708|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662709|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662710|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662711|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662712|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662713|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662714|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662715|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662716|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662717|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662718|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662719|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662879|NCT01163604|O2|Outcome|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
662720|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662721|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662722|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662723|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662724|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662725|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662726|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662727|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662728|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662729|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662730|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662731|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662732|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662733|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662734|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662735|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662736|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662737|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662738|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662739|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662880|NCT01163604|O1|Outcome|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.
Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
662740|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662741|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662742|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662743|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662744|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662745|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662746|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662747|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662748|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662749|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662750|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662751|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662752|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662753|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662754|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662755|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662756|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662757|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662758|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662759|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662881|NCT01163604|E2|Reported Event|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
662760|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662761|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662762|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662763|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662764|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662765|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662766|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662767|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662768|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662769|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662770|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662771|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662772|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662773|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662774|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662775|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662776|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662777|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662778|NCT01163253|O2|Outcome|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662779|NCT01163253|O1|Outcome|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662882|NCT01163604|E1|Reported Event|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.
Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
662780|NCT01163253|E2|Reported Event|Tofacitinib 5 mg or 10 mg|Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator’s discretion.
662781|NCT01163253|E1|Reported Event|Tofacitinib 10 mg|Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).
662782|NCT01163266|B4|Baseline|Total|Total of all reporting groups
662783|NCT01163266|B3|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
662784|NCT01163266|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
662785|NCT01163266|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
662786|NCT01163266|P3|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
662787|NCT01163266|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
662788|NCT01163266|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
662789|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
662790|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
662791|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
662792|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
662793|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
662794|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
662795|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
662796|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
662797|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
662798|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
662799|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
662800|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
662801|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
662802|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
662803|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
662804|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
662805|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
662806|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
662808|NCT01163266|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
662811|NCT01163279|B2|Baseline|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
662812|NCT01163279|B1|Baseline|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662813|NCT01163279|P2|Participant Flow|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
662883|NCT01163617|B1|Baseline|All Study Participants|Includes participants from Phases A and B of the study
662884|NCT01163617|P8|Participant Flow|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
662814|NCT01163279|P1|Participant Flow|Cogntive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662815|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
662816|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662817|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
662818|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662819|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
662820|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662821|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
662869|NCT01163474|P1|Participant Flow|Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua|Evaluate video clinic visit prior to Face-to-Face usual care visit
662870|NCT01163474|O1|Outcome|Arm 1 - Provider Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit
Evaluative process: Evaluative process using video conferencing"
662927|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
662822|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662823|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
662824|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662825|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
662885|NCT01163617|P7|Participant Flow|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
662826|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662827|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
662828|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662829|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
662830|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662831|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
662832|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662833|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
662834|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662835|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
662836|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662837|NCT01163279|E2|Reported Event|Psychosocial Education|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
663708|NCT01165983|O2|Outcome|T2DM Patients|
662838|NCT01163279|E1|Reported Event|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
662839|NCT01163292|B3|Baseline|Total|Total of all reporting groups
662840|NCT01163292|B2|Baseline|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
662841|NCT01163292|B1|Baseline|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
662842|NCT01163292|P2|Participant Flow|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
662843|NCT01163292|P1|Participant Flow|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
662844|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
662845|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
662846|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
662847|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
662848|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
662849|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
662850|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
662851|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
662852|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
662853|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
662854|NCT01163292|E2|Reported Event|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
662855|NCT01163292|E1|Reported Event|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
662856|NCT01163318|B1|Baseline|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
662857|NCT01163318|P1|Participant Flow|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
662858|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
662859|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
662860|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
662861|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
662862|NCT01163318|E1|Reported Event|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
662868|NCT01163474|B1|Baseline|Arm 1 - Evaluate Video Clinic Visit|Evaluate video clinic visit prior to Face-to-Face usual care visit
662871|NCT01163474|O1|Outcome|Arm 1 - Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit
Evaluative process: Evaluative process using video conferencing"
662872|NCT01163474|E2|Reported Event|Arm 2|Face-to-face follow up for subjects (control)
662873|NCT01163474|E1|Reported Event|Arm 1 - Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit
Evaluative process: Evaluative process using video conferencing"
662874|NCT01163604|B3|Baseline|Total|Total of all reporting groups
662875|NCT01163604|B2|Baseline|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
662886|NCT01163617|P6|Participant Flow|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
662889|NCT01163617|P3|Participant Flow|Current Autoinjector First, Then Physiolis Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
662890|NCT01163617|P2|Participant Flow|Physiolis Syringe First, Then Current Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
662891|NCT01163617|P1|Participant Flow|Current Syringe First, Then Physiolis Syringe|Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
662892|NCT01163617|O2|Outcome|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C)
662893|NCT01163617|O1|Outcome|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C)
662894|NCT01163617|O2|Outcome|Physiolis Autoinjector|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C)
662895|NCT01163617|O1|Outcome|Current Autoinjector|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C)
662896|NCT01163617|O2|Outcome|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C)
662897|NCT01163617|O1|Outcome|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C)
662898|NCT01163617|O4|Outcome|Physiolis/Current Autoinjector|Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2)
662899|NCT01163617|O3|Outcome|Current/Physiolis Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2)
662900|NCT01163617|O2|Outcome|Physiolis/Current Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2)
662901|NCT01163617|O1|Outcome|Current/Physiolis Syringe|Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2)
662902|NCT01163617|E8|Reported Event|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
662903|NCT01163617|E7|Reported Event|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
662904|NCT01163617|E6|Reported Event|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
662905|NCT01163617|E5|Reported Event|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
662906|NCT01163617|E4|Reported Event|Physiolis Autoinjector|Self-injection using Physiolis autoinjector at Week 0 or Week 2 (Visit 2) (Phase A)
662907|NCT01163617|E3|Reported Event|Current Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
662908|NCT01163617|E2|Reported Event|Physiolis Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
662909|NCT01163617|E1|Reported Event|Current Syringe|Self-injection using current syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
662910|NCT01163656|B3|Baseline|Total|Total of all reporting groups
662911|NCT01163656|B2|Baseline|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
662912|NCT01163656|B1|Baseline|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
662913|NCT01163656|P2|Participant Flow|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
662914|NCT01163656|P1|Participant Flow|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
662915|NCT01163656|O2|Outcome|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
662916|NCT01163656|O1|Outcome|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
662917|NCT01163656|E2|Reported Event|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
662918|NCT01163656|E1|Reported Event|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
662919|NCT01163721|B3|Baseline|Total|Total of all reporting groups
662920|NCT01163721|B2|Baseline|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
662921|NCT01163721|B1|Baseline|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
662922|NCT01163721|P2|Participant Flow|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
662923|NCT01163721|P1|Participant Flow|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
662924|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
662925|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
662928|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
662929|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
662930|NCT01163721|E2|Reported Event|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
662931|NCT01163721|E1|Reported Event|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
662932|NCT01163747|B3|Baseline|Total|Total of all reporting groups
662933|NCT01163747|B2|Baseline|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662934|NCT01163747|B1|Baseline|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662935|NCT01163747|P2|Participant Flow|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662936|NCT01163747|P1|Participant Flow|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662937|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662938|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662939|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662940|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662941|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662942|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662943|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662944|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662945|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662946|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662947|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662948|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662949|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662950|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662951|NCT01163747|E2|Reported Event|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662952|NCT01163747|E1|Reported Event|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
662953|NCT01163760|B1|Baseline|Overall|Total number of completed participants are included in baseline measurements.
662954|NCT01163760|P4|Participant Flow|Ocufilcon D First, Then Ocufilcon D|Ocufilcon D contact lenses worn for both periods.
662955|NCT01163760|P3|Participant Flow|Etafilcon A First, Then Etafilcon A|etafilcon A contact lenses worn for both periods.
662956|NCT01163760|P2|Participant Flow|Ocufilcon D First, Then Etafilcon A|ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
662957|NCT01163760|P1|Participant Flow|Etafilcon A First, Then Ocufilcon D|etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
662958|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
662959|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
662960|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
662961|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
662962|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
662963|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
662966|NCT01163760|E2|Reported Event|Ocufilcon D / Etafilcon A|ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
662967|NCT01163760|E1|Reported Event|Etafilcon A/ Ocufilcon D|etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
662968|NCT01163851|B3|Baseline|Total|Total of all reporting groups
662969|NCT01163851|B2|Baseline|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662970|NCT01163851|B1|Baseline|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662971|NCT01163851|P2|Participant Flow|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662972|NCT01163851|P1|Participant Flow|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662973|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662974|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662975|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662976|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662977|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662978|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662979|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662980|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662981|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662982|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663058|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
662983|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662984|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663067|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
663709|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
662985|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662986|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662987|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662988|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662989|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662990|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662991|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662992|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662993|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662994|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662995|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662996|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662997|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662998|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
662999|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663000|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663001|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663068|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663069|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
663002|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663003|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663004|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663005|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663006|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663007|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663008|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663009|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663010|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663011|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663012|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663013|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663014|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663015|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663059|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663060|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
663016|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663017|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663018|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663070|NCT01163916|O4|Outcome|Missing|Participants for whom acceptability data were not available.
663071|NCT01163916|O3|Outcome|Need Assistance|Participants who were unable to self-inject.
663019|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663020|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663021|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663022|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663023|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663024|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663025|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663026|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663027|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663028|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663029|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663030|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663031|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663032|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663033|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663034|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663035|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663072|NCT01163916|O2|Outcome|Not Convenient|"Participants who described the acceptability of adalimumab injections as not convenient."
663073|NCT01163916|O1|Outcome|Convenient|"Participants who described the acceptability of adalimumab injections as convenient."
663036|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663037|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663038|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663039|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663040|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663041|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663042|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663043|NCT01163851|E2|Reported Event|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663044|NCT01163851|E1|Reported Event|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
663045|NCT01163916|B4|Baseline|Total|Total of all reporting groups
663046|NCT01163916|B3|Baseline|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
663047|NCT01163916|B2|Baseline|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663048|NCT01163916|B1|Baseline|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
663049|NCT01163916|P3|Participant Flow|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
663050|NCT01163916|P2|Participant Flow|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663051|NCT01163916|P1|Participant Flow|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
663052|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
663053|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663054|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
663055|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
663056|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663057|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
663061|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
663062|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663063|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
663064|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
663065|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663066|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
663074|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
663075|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663076|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
663077|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
663078|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663079|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
663080|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
663081|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663082|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.
663083|NCT01163916|E3|Reported Event|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
663084|NCT01163916|E2|Reported Event|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
663085|NCT01163916|E1|Reported Event|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
663086|NCT01163955|B3|Baseline|Total|Total of all reporting groups
663087|NCT01163955|B2|Baseline|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
663088|NCT01163955|B1|Baseline|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
663089|NCT01163955|P2|Participant Flow|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
663090|NCT01163955|P1|Participant Flow|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
663091|NCT01163955|O2|Outcome|Postural Score Sitting in a Chair After 5 Minutes|Children sat in a chair for five minutes while playing a video game. No intervention (verbal or non-verbal) was given to them.
663092|NCT01163955|O1|Outcome|Postural Score Sitting on Floor After 5 Minutes|Children sat on the floor for five minutes while playing a video game. No intervention (verbal or non-verbal) was given to them.
663093|NCT01163955|E2|Reported Event|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
663094|NCT01163955|E1|Reported Event|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
663095|NCT01164007|B1|Baseline|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663096|NCT01164007|P1|Participant Flow|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Day 1 and bevacizumab as 10 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663097|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663098|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663099|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663100|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663204|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663101|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663102|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663103|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663104|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663105|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663106|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663107|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663108|NCT01164007|E1|Reported Event|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
663109|NCT01164644|B3|Baseline|Total|Total of all reporting groups
663110|NCT01164644|B2|Baseline|Placebo|The subject will take twelve pills by mouth three times a day over four days.
663111|NCT01164644|B1|Baseline|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
663112|NCT01164644|P2|Participant Flow|Placebo|The subject will take twelve pills by mouth three times a day over four days.
663113|NCT01164644|P1|Participant Flow|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
663114|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
663115|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
663116|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
663117|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
663118|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
663119|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
663120|NCT01164644|E2|Reported Event|Placebo|The subject will take twelve pills by mouth three times a day over four days.
663121|NCT01164644|E1|Reported Event|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
663122|NCT01164722|B3|Baseline|Total|Total of all reporting groups
663123|NCT01164722|B2|Baseline|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
clinical observation: Patients undergo observation"
663124|NCT01164722|B1|Baseline|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
infrared photocoagulation therapy: Anal infrared coagulator ablation"
663125|NCT01164722|P2|Participant Flow|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
clinical observation: Patients undergo observation"
663126|NCT01164722|P1|Participant Flow|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
infrared photocoagulation therapy: Anal infrared coagulator ablation"
663127|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
clinical observation: Patients undergo observation"
663256|NCT01165177|P1|Participant Flow|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
663689|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663128|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
infrared photocoagulation therapy: Anal infrared coagulator ablation"
663129|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
clinical observation: Patients undergo observation"
663130|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
infrared photocoagulation therapy: Anal infrared coagulator ablation"
663131|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
clinical observation: Patients undergo observation"
663266|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
663132|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
infrared photocoagulation therapy: Anal infrared coagulator ablation"
663133|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
clinical observation: Patients undergo observation"
663134|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
infrared photocoagulation therapy: Anal infrared coagulator ablation"
663135|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
clinical observation: Patients undergo observation"
663136|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
infrared photocoagulation therapy: Anal infrared coagulator ablation"
663137|NCT01164722|E2|Reported Event|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
clinical observation: Patients undergo observation"
663138|NCT01164722|E1|Reported Event|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
infrared photocoagulation therapy: Anal infrared coagulator ablation"
663139|NCT01164865|B3|Baseline|Total|Total of all reporting groups
663140|NCT01164865|B2|Baseline|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
663141|NCT01164865|B1|Baseline|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
663142|NCT01164865|P2|Participant Flow|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
663143|NCT01164865|P1|Participant Flow|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
663144|NCT01164865|O2|Outcome|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
663145|NCT01164865|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
663146|NCT01164865|O2|Outcome|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
663147|NCT01164865|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
663148|NCT01164865|E2|Reported Event|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
663149|NCT01164865|E1|Reported Event|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
663150|NCT01164891|B1|Baseline|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663151|NCT01164891|P1|Participant Flow|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 milligrams (mg) orally two times daily (BID) from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663257|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
663152|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663153|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663154|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663267|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
663155|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15 participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663156|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663157|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663158|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663159|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663160|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663161|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663162|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663163|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663164|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663165|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663166|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663167|NCT01164891|E1|Reported Event|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
663268|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
663168|NCT01165021|B1|Baseline|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
663169|NCT01165021|P1|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
663170|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
663171|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
663172|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
663173|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
663174|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
663175|NCT01165021|E1|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
663176|NCT01165047|B1|Baseline|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM
Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
663177|NCT01165047|P1|Participant Flow|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM
Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
663178|NCT01165047|O1|Outcome|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM
Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
663179|NCT01165047|E1|Reported Event|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM
Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
663180|NCT01165112|B1|Baseline|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies"
663181|NCT01165112|P1|Participant Flow|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies"
663182|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies"
663183|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies"
663184|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies"
663185|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies"
663710|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663186|NCT01165112|E1|Reported Event|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Carboplatin: Given IV
Rituximab: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies"
663187|NCT01165138|B4|Baseline|Total|Total of all reporting groups
663188|NCT01165138|B3|Baseline|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663189|NCT01165138|B2|Baseline|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663190|NCT01165138|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663191|NCT01165138|P4|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663192|NCT01165138|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663193|NCT01165138|P2|Participant Flow|Placebo|Participants (par.) received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663194|NCT01165138|P1|Participant Flow|Current Anti-asthma Therapy at a Fixed Dose|Participants were instructed to continue using an approved fixed dose of an inhaled corticosteroid (ICS) for 4 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Run-in Period.
663195|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663196|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663197|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663198|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663199|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663200|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663201|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663202|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663203|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663690|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663205|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663206|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663207|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663208|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663209|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663269|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
663210|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663211|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663212|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663213|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663214|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663215|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663216|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663217|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663218|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663219|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663220|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663221|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663222|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663223|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663224|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663225|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663226|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663227|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663228|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663258|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
663229|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663230|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663231|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663232|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663233|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663234|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663235|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663236|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663237|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663238|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663239|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663240|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663241|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663242|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663243|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663244|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663245|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663246|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663247|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663248|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663249|NCT01165138|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663250|NCT01165138|E2|Reported Event|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663251|NCT01165138|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
663252|NCT01165177|B3|Baseline|Total|Total of all reporting groups
663253|NCT01165177|B2|Baseline|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
663254|NCT01165177|B1|Baseline|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
663255|NCT01165177|P2|Participant Flow|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
663259|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
663260|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
663261|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
663262|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
663263|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
663264|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
663265|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
663711|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663270|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
663271|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663272|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663273|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663274|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663275|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663276|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663277|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663278|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663279|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663280|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663281|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663282|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663283|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663284|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663285|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663286|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663287|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663288|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663289|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663290|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663291|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663292|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663293|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663294|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663295|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663296|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663297|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663298|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663299|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663300|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663301|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663302|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663303|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663549|NCT01165307|B3|Baseline|Total|Total of all reporting groups
663304|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663305|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663306|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663307|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663308|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663309|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663310|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663712|NCT01165983|O2|Outcome|T2DM Patients|
663311|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663312|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663313|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663314|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663315|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663316|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663317|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663318|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663319|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663320|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663321|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663322|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663323|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663324|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663325|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663326|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663327|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663328|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663329|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663330|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663331|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663332|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663333|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663334|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663335|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663336|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663337|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663338|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663339|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663340|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663341|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663342|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663343|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663344|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663345|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663346|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663347|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663348|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663349|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663350|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663351|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663713|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
663352|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663353|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663354|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663355|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663356|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663357|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663358|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663359|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663360|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663361|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663362|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663363|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663364|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663365|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663366|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663367|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663368|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663369|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663370|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
663371|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663372|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663373|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663374|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
663375|NCT01165177|E2|Reported Event|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
663376|NCT01165177|E1|Reported Event|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
663377|NCT01165203|B3|Baseline|Total|Total of all reporting groups
663378|NCT01165203|B2|Baseline|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663379|NCT01165203|B1|Baseline|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663380|NCT01165203|P2|Participant Flow|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663381|NCT01165203|P1|Participant Flow|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663382|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663383|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663384|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663385|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663386|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663387|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663388|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663389|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663390|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663391|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663392|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663393|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663394|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663395|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663396|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663397|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663398|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663399|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663400|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663401|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663402|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663403|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663404|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663405|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663406|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663407|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663408|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663409|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663410|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663411|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663412|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663413|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663414|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663415|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663416|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663714|NCT01165983|E2|Reported Event|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663417|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663418|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663419|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663420|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663421|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663422|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663423|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663424|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663425|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663426|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663427|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663428|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663429|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663430|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663431|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663432|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663433|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663434|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663435|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663436|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663437|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663438|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663439|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663440|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663441|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663442|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663443|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663444|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663445|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663446|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663447|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663448|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663449|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663450|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663451|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663452|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663453|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663454|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663455|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663456|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663457|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663458|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663459|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663460|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663461|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663462|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663463|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663464|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663465|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663466|NCT01165203|E2|Reported Event|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663467|NCT01165203|E1|Reported Event|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
663468|NCT01165216|B3|Baseline|Total|Total of all reporting groups
663469|NCT01165216|B2|Baseline|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663470|NCT01165216|B1|Baseline|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663471|NCT01165216|P2|Participant Flow|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663472|NCT01165216|P1|Participant Flow|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663473|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30 -60 minutes every 3 weeks (up to 6 doses).
663474|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663715|NCT01165983|E1|Reported Event|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663475|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663476|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663477|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663478|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663479|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663480|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663481|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663482|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663483|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663484|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663485|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663486|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663487|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663488|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663489|NCT01165216|E2|Reported Event|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663490|NCT01165216|E1|Reported Event|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
663491|NCT01165242|B4|Baseline|Total|Total of all reporting groups
663492|NCT01165242|B3|Baseline|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663493|NCT01165242|B2|Baseline|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663494|NCT01165242|B1|Baseline|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663495|NCT01165242|P3|Participant Flow|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663496|NCT01165242|P2|Participant Flow|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663497|NCT01165242|P1|Participant Flow|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663498|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663499|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663500|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663501|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663502|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663503|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663504|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663505|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663506|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663507|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663508|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663509|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663510|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663511|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663512|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663513|NCT01165242|O1|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663514|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663515|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663691|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663516|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663517|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663518|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663519|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663520|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663521|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663522|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663523|NCT01165242|O2|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663524|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663525|NCT01165242|E3|Reported Event|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663526|NCT01165242|E2|Reported Event|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663527|NCT01165242|E1|Reported Event|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
663528|NCT01165281|B3|Baseline|Total|Total of all reporting groups
663529|NCT01165281|B2|Baseline|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663530|NCT01165281|B1|Baseline|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663531|NCT01165281|P2|Participant Flow|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663532|NCT01165281|P1|Participant Flow|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663550|NCT01165307|B2|Baseline|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663692|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663693|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663533|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663534|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663554|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663535|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663536|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663537|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663538|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663539|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663540|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663541|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663542|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663555|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663543|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663544|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663545|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663546|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663547|NCT01165281|E2|Reported Event|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663548|NCT01165281|E1|Reported Event|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
663551|NCT01165307|B1|Baseline|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663552|NCT01165307|P2|Participant Flow|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663553|NCT01165307|P1|Participant Flow|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663614|NCT01165554|P1|Participant Flow|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
663556|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663557|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663558|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663559|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663560|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663561|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663562|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663563|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663564|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663565|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663566|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663567|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663682|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663568|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663569|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663570|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663589|NCT01165320|O1|Outcome|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively
663705|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
663571|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663572|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663573|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663574|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663575|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663576|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663577|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663578|NCT01165307|E2|Reported Event|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
663579|NCT01165307|E1|Reported Event|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
663580|NCT01165320|B3|Baseline|Total|Total of all reporting groups
663581|NCT01165320|B2|Baseline|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
663582|NCT01165320|B1|Baseline|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
663583|NCT01165320|P3|Participant Flow|Participants With Esophageal Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively.
663683|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663684|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663584|NCT01165320|P2|Participant Flow|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
663585|NCT01165320|P1|Participant Flow|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
663586|NCT01165320|O2|Outcome|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively
663587|NCT01165320|O1|Outcome|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively
663588|NCT01165320|O2|Outcome|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively
663613|NCT01165554|B1|Baseline|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
663590|NCT01165320|E2|Reported Event|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
663591|NCT01165320|E1|Reported Event|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
663592|NCT01165424|B1|Baseline|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.
Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.
Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
663593|NCT01165424|P1|Participant Flow|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.
Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.
Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
663594|NCT01165424|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.
Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.
Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
663595|NCT01165424|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.
Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.
Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
663596|NCT01165424|E1|Reported Event|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.
Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.
Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
663597|NCT01165450|B1|Baseline|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
663598|NCT01165450|P1|Participant Flow|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
663599|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
663600|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
663601|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
663602|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
663603|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
663604|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
663685|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663686|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663605|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
663606|NCT01165450|E1|Reported Event|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
663607|NCT01165541|B1|Baseline|Entire Study Population|Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg) for 7 weeks.
663608|NCT01165541|P1|Participant Flow|Entire Study Population|Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg) for 7 weeks.
663609|NCT01165541|O2|Outcome|Quetiapine XR Plus Mirtazapine|"Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg
Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg)"
663610|NCT01165541|O1|Outcome|Quetiapine Fumarate Extended Release (Quetiapine XR)|"Quetiapine XR 50-400mg
Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d"
663611|NCT01165541|E2|Reported Event|Quetiapine XR andMirtazapine|"Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg
Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg)"
663612|NCT01165541|E1|Reported Event|Quetiapine Fumarate Extended Release (Quetiapine XR)|"Quetiapine XR 50-400mg
Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d"
663615|NCT01165554|O1|Outcome|Specificity-Normal Visual Reads|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
663616|NCT01165554|O1|Outcome|Sensitivity-Abnormal Visual Reads|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
663617|NCT01165554|O1|Outcome|Specificity Percentage of Normal Visual Reads|
663618|NCT01165554|O1|Outcome|Sensitivity Percentage of Abnormal Visual Reads|
663619|NCT01165554|E1|Reported Event|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
663620|NCT01165684|B3|Baseline|Total|Total of all reporting groups
663621|NCT01165684|B2|Baseline|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663622|NCT01165684|B1|Baseline|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663623|NCT01165684|P2|Participant Flow|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663624|NCT01165684|P1|Participant Flow|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663625|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663626|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663627|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663628|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663629|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663630|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663631|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663687|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663632|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663633|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663634|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663635|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663636|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663637|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663638|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663639|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663640|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663641|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663642|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663643|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663644|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663645|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663646|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663647|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663648|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663649|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663650|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663688|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663651|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663652|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663653|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663654|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663655|NCT01165684|E2|Reported Event|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
663656|NCT01165684|E1|Reported Event|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
663706|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663657|NCT01165775|B1|Baseline|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.
Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.
Data are available for 15 of 17 participants."
663658|NCT01165775|P1|Participant Flow|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.
Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
663659|NCT01165775|O3|Outcome|Neonates With Unknown Hypoglycemia Status|Neonates with unknown hypoglycemia status from birth to hospital discharge.
663660|NCT01165775|O2|Outcome|Neonates Without Hypoglycemia|Neonates without hypoglycemia from birth to hospital discharge.
663661|NCT01165775|O1|Outcome|Neonates With Hypoglycemia|Neonates with hypoglycemia from birth to hospital discharge.
663662|NCT01165775|O2|Outcome|Diabetic Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.
Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
663663|NCT01165775|O1|Outcome|Non-Diabetic Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.
Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
663664|NCT01165775|E1|Reported Event|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.
Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
663665|NCT01165840|B1|Baseline|Dapsone|"Dapsone 100 mg PO x 1 dose
Dapsone: 100 mg PO x 1 dose"
663666|NCT01165840|P1|Participant Flow|Dapsone|"Dapsone 100 mg PO x 1 dose
Dapsone: 100 mg PO x 1 dose"
663667|NCT01165840|O1|Outcome|Dapsone|"Dapsone 100 mg PO x 1 dose
Dapsone: 100 mg PO x 1 dose"
663668|NCT01165840|E1|Reported Event|Dapsone|"Dapsone 100 mg PO x 1 dose
Dapsone: 100 mg PO x 1 dose"
663669|NCT01165983|B3|Baseline|Total|Total of all reporting groups
663670|NCT01165983|B2|Baseline|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663671|NCT01165983|B1|Baseline|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663672|NCT01165983|P2|Participant Flow|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663673|NCT01165983|P1|Participant Flow|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663674|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663675|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663676|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663677|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663678|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663679|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663680|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663681|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663694|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663695|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663696|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663697|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663698|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663699|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663700|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663701|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663702|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
663703|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
663704|NCT01165983|O2|Outcome|T2DM Patients|
663716|NCT01165996|B1|Baseline|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
663717|NCT01165996|P1|Participant Flow|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
663718|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
663719|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
663720|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
663721|NCT01165996|E1|Reported Event|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
663722|NCT01166126|B1|Baseline|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).
Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.
The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
663723|NCT01166126|P1|Participant Flow|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).
Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.
The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
663724|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).
Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.
The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
663725|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).
Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.
The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
663756|NCT01166178|E2|Reported Event|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663757|NCT01166178|E1|Reported Event|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663758|NCT01166230|B3|Baseline|Total|Total of all reporting groups
663802|NCT01166646|P2|Participant Flow|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream
Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663726|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).
Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.
The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
663764|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
663765|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
663766|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
663727|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).
Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.
The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
663728|NCT01166126|E1|Reported Event|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).
Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.
The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
663729|NCT01166178|B3|Baseline|Total|Total of all reporting groups
663730|NCT01166178|B2|Baseline|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663731|NCT01166178|B1|Baseline|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663732|NCT01166178|P2|Participant Flow|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663733|NCT01166178|P1|Participant Flow|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663734|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663735|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663736|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663737|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663738|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663739|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663740|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663741|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663742|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663743|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663744|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663745|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663746|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663747|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663748|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663749|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663750|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663751|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663752|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663753|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663754|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
663755|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
663759|NCT01166230|B2|Baseline|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
663760|NCT01166230|B1|Baseline|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
663761|NCT01166230|P2|Participant Flow|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
663762|NCT01166230|P1|Participant Flow|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
663763|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
663767|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
663768|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
663769|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
663770|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
663771|NCT01166230|E2|Reported Event|Patients With Ta/T1, Randomized to White Light Cystoscopy|
663772|NCT01166230|E1|Reported Event|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
663773|NCT01166282|B3|Baseline|Total|Total of all reporting groups
663774|NCT01166282|B2|Baseline|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
663775|NCT01166282|B1|Baseline|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
663776|NCT01166282|P3|Participant Flow|Open-label Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.
663777|NCT01166282|P2|Participant Flow|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
663778|NCT01166282|P1|Participant Flow|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
663779|NCT01166282|O3|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
663780|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
663781|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
663782|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
663783|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
663784|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
663785|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
663786|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
663787|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
663788|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
663789|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
663790|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
663791|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
663792|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
663793|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
663794|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
663795|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
663796|NCT01166282|E3|Reported Event|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
663797|NCT01166282|E2|Reported Event|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
663798|NCT01166282|E1|Reported Event|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
663799|NCT01166646|B3|Baseline|Total|Total of all reporting groups
663800|NCT01166646|B2|Baseline|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream
Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663801|NCT01166646|B1|Baseline|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion
Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663803|NCT01166646|P1|Participant Flow|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion
Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663804|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream
Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663805|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion
Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663806|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream
Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663807|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion
Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
664952|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
663808|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream
Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663809|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion
Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663810|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream
Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663811|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion
Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663812|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream
Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663813|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion
Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663814|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream
Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663815|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion
Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
663816|NCT01166646|E2|Reported Event|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream
Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for 1-2 weeks"
663817|NCT01166646|E1|Reported Event|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion
Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for 1-2 weeks"
663818|NCT01166659|B1|Baseline|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
663819|NCT01166659|P1|Participant Flow|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
663820|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
663821|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
663822|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
663823|NCT01166659|E2|Reported Event|Ocular Adverse Events|At risk population for ocular adverse events is included with unit of eyes.
663824|NCT01166659|E1|Reported Event|Non-Ocular Adverse Events|At risk population for non-ocular adverse events is included with unit of subjects
663825|NCT01166724|B3|Baseline|Total|Total of all reporting groups
663826|NCT01166724|B2|Baseline|Tacrolimus|Patient will stay on Tacrolimus
663827|NCT01166724|B1|Baseline|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus
Sirolumus: Tacrolimus to Sirolimus
Tacrolimus: dosage per trough level"
663828|NCT01166724|P2|Participant Flow|Tacrolimus|Patient will stay on Tacrolimus
663829|NCT01166724|P1|Participant Flow|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus
Sirolumus: Tacrolimus to Sirolimus
Tacrolimus: dosage per trough level"
663830|NCT01166724|O2|Outcome|Tacrolimus|Patient will stay on Tacrolimus
663831|NCT01166724|O1|Outcome|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus
Sirolumus: Tacrolimus to Sirolimus
Tacrolimus: dosage per trough level"
663832|NCT01166724|O2|Outcome|Tacrolimus|Patient will stay on Tacrolimus
663833|NCT01166724|O1|Outcome|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus
Sirolumus: Tacrolimus to Sirolimus
Tacrolimus: dosage per trough level"
663834|NCT01166724|E2|Reported Event|Tacrolimus|Patient will stay on Tacrolimus
663835|NCT01166724|E1|Reported Event|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus
Sirolumus: Tacrolimus to Sirolimus
Tacrolimus: dosage per trough level"
663836|NCT01166750|B3|Baseline|Total|Total of all reporting groups
663837|NCT01166750|B2|Baseline|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
663838|NCT01166750|B1|Baseline|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
663839|NCT01166750|P2|Participant Flow|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
663840|NCT01166750|P1|Participant Flow|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
663841|NCT01166750|O2|Outcome|Wait-List Control Group|
663842|NCT01166750|O1|Outcome|CD-ROM Treatment|Jointstrong
663904|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
663905|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
663843|NCT01166750|E2|Reported Event|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
663844|NCT01166750|E1|Reported Event|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
663845|NCT01166763|B1|Baseline|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3
vitamin D3: oral capsules, 10,000 IU per week for 6 months"
663846|NCT01166763|P1|Participant Flow|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3
vitamin D3: oral capsules, 10,000 IU per week for 6 months"
663847|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3
vitamin D3: oral capsules, 10,000 IU per week for 6 months"
663848|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3
vitamin D3: oral capsules, 10,000 IU per week for 6 months"
663849|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3
vitamin D3: oral capsules, 10,000 IU per week for 6 months"
663850|NCT01166763|E1|Reported Event|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3
vitamin D3: oral capsules, 10,000 IU per week for 6 months"
663851|NCT01166958|B3|Baseline|Total|Total of all reporting groups
663852|NCT01166958|B2|Baseline|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
663853|NCT01166958|B1|Baseline|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
663854|NCT01166958|P2|Participant Flow|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
663855|NCT01166958|P1|Participant Flow|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
663856|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
663857|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
663858|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
663859|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
663860|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
663861|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
663894|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
663862|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
663863|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
663864|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
664953|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
663865|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
663866|NCT01166958|E2|Reported Event|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
663867|NCT01166958|E1|Reported Event|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
663868|NCT01166971|B3|Baseline|Total|Total of all reporting groups
663869|NCT01166971|B2|Baseline|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
663870|NCT01166971|B1|Baseline|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
663871|NCT01166971|P2|Participant Flow|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
663872|NCT01166971|P1|Participant Flow|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
663873|NCT01166971|O2|Outcome|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
663874|NCT01166971|O1|Outcome|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
663875|NCT01166971|E2|Reported Event|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
663876|NCT01166971|E1|Reported Event|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
663877|NCT01166997|B3|Baseline|Total|Total of all reporting groups
663878|NCT01166997|B2|Baseline|UFH + EkoSonic Procedure|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
663879|NCT01166997|B1|Baseline|UFH (Alone)|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
663880|NCT01166997|P2|Participant Flow|Unfractionated Heparin (UFH) + EkoSonic Procedure|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
663881|NCT01166997|P1|Participant Flow|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
663882|NCT01166997|O2|Outcome|Intravenous Unfractionated Heparin|"Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.
Unfractionated heparin: Intravenous unfractionated heparin used for anticoagulation treatment"
663883|NCT01166997|O1|Outcome|Ultrasound Accelerated Thrombolysis|"Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
EkoSonic Endovascular System: The EkoSonic Endovascular System will be used to deliver < 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus."
663884|NCT01166997|O2|Outcome|Unfractionated Heprin + EkoSonic Procedure|Patients in this arm received anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
663885|NCT01166997|O1|Outcome|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
663886|NCT01166997|E2|Reported Event|UFH + EkoSonic|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
663887|NCT01166997|E1|Reported Event|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
663888|NCT01167023|B3|Baseline|Total|Total of all reporting groups
663889|NCT01167023|B2|Baseline|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
663890|NCT01167023|B1|Baseline|Placebo|Participants received placebo orally, once daily for 30 days.
663891|NCT01167023|P3|Participant Flow|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
663892|NCT01167023|P2|Participant Flow|Placebo|Participants received placebo orally, once daily for 30 days.
663893|NCT01167023|P1|Participant Flow|7.5 mg Prasugrel|Participants were to receive 7.5 milligrams (mg) of prasugrel orally, once daily if they weighed ≥60 kilograms (kg) and if pharmacodynamic (PD) measures indicated that the 5-mg prasugrel dose did not produce a steady-state PD response equivalent to inhibition of platelet activation (IPA) ≥25%. Because these criteria were not met, no participants received 7.5 mg of prasugrel.
663895|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
663896|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
663897|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
663898|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
663899|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
663900|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
663901|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
663902|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
663903|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
663906|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
663907|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
663908|NCT01167023|E2|Reported Event|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
663909|NCT01167023|E1|Reported Event|Placebo|Participants received placebo orally, once daily for 30 days.
663910|NCT01160744|B5|Baseline|Total|Total of all reporting groups
663911|NCT01160744|B4|Baseline|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663912|NCT01160744|B3|Baseline|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663913|NCT01160744|B2|Baseline|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663914|NCT01160744|B1|Baseline|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663915|NCT01160744|P4|Participant Flow|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of each every 21-day cycle. Participants were treated for up to 89 weeks.
663916|NCT01160744|P3|Participant Flow|Gem + Carb or Cis (Squamous)|"Gemcitabine (Gem): 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb [Area Under the Concentration Time Curve 5 (AUC 5)]: Day 1 of every 21-day cycle.
Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks."
663917|NCT01160744|P2|Participant Flow|Ram + Pem + Carb or Cis (Non-Squamous)|Ramucirumab (Ram): 10 milligrams/kilogram (mg/kg) Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663918|NCT01160744|P1|Participant Flow|Pem + Carb or Cis (Non-Squamous)|"Pemetrexed (Pem): 500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle.
Carboplatin (Carb) [Area Under the Concentration Time Curve 6 (AUC 6)] : Day 1 of every 21-day cycle.
Cisplatin (Cis): 75 mg/m² intravenous (IV) on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks."
663919|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663920|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663921|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cisplatin: 75 mg/m² IV on Day 1 of each 21-day cycle. Participants were treated for up to 89 weeks.
663922|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663923|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663924|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663925|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cisplatin: 75 mg/m² IV on Day 1 of each 21-day cycle. Participants were treated for up to 89 weeks.
663926|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663927|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663928|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663929|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663930|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663931|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663932|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663933|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663934|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663935|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663936|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663937|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663938|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663939|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663940|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663941|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663942|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663943|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663944|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663945|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663946|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663947|NCT01160744|E4|Reported Event|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663948|NCT01160744|E3|Reported Event|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663949|NCT01160744|E2|Reported Event|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663950|NCT01160744|E1|Reported Event|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
663951|NCT01160770|B1|Baseline|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
663952|NCT01160770|P1|Participant Flow|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
663953|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
663954|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
663955|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
663956|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
663957|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
663958|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
663959|NCT01160770|E1|Reported Event|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
663961|NCT01160822|B7|Baseline|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
663962|NCT01160822|B6|Baseline|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
663963|NCT01160822|B5|Baseline|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
663964|NCT01160822|B4|Baseline|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
663965|NCT01160822|B3|Baseline|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
664954|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
663966|NCT01160822|B2|Baseline|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
663967|NCT01160822|B1|Baseline|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
663968|NCT01160822|P7|Participant Flow|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
663969|NCT01160822|P6|Participant Flow|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
663970|NCT01160822|P5|Participant Flow|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
663971|NCT01160822|P4|Participant Flow|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
663972|NCT01160822|P3|Participant Flow|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
663973|NCT01160822|P2|Participant Flow|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
663974|NCT01160822|P1|Participant Flow|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
663975|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
663976|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
663977|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
663978|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
663979|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
663980|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
663981|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
663982|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
663983|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
663984|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
663985|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
663986|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
663987|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
663988|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
663989|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
663990|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
663991|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
663992|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
663993|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
663994|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
663995|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
663996|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
663997|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
663998|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
663999|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664000|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
664001|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
664002|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
664003|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664004|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664005|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664006|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664007|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664008|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664009|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664010|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664011|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664012|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664013|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664014|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664015|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664016|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664017|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664018|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664019|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664020|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664021|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664022|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664023|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664024|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664025|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664026|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664027|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664028|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664029|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664030|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664031|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664032|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664033|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664034|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664035|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664084|NCT01160848|O1|Outcome|Part 1: Area Cleaned With Saline and Occluded With Tegaderm|
664036|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664037|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664038|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664039|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664040|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664495|NCT01168674|O1|Outcome|Placebo|Subjects randomized to placebo in either the initial or crossover phase
664041|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664042|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664043|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664044|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664045|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664046|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664047|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664048|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664049|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664050|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664051|NCT01160822|O4|Outcome|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
664052|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
664053|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
664054|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
664055|NCT01160822|E7|Reported Event|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
664056|NCT01160822|E6|Reported Event|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664057|NCT01160822|E5|Reported Event|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
664058|NCT01160822|E4|Reported Event|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
664059|NCT01160822|E3|Reported Event|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
664060|NCT01160822|E2|Reported Event|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
664061|NCT01160822|E1|Reported Event|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
664062|NCT01160848|B3|Baseline|Total|Total of all reporting groups
664063|NCT01160848|B2|Baseline|3 Areas Per Patient, 24 Hours|
664064|NCT01160848|B1|Baseline|3 Areas Per Patient, 3 Hours|
664065|NCT01160848|P2|Participant Flow|3 Areas Per Patient, 24 Hours|Group 1: Visonac left on skin for 1 hour Group 2: Visonac left on skin for 24 hours, area 1 Group 3: Visonac left on skin for 24 hours, area 2
664066|NCT01160848|P1|Participant Flow|3 Areas Per Patient, 3 Hours|Visonac : MAL 80 mg/g Group 1: Alcohol wipe and Visonac without occlusion Group 2: Saline wipe and Visonac with occlusion Group 3: Saline wipe and Visonac without occlusion
664067|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
664068|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
664069|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
664070|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
664071|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
664072|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
664073|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
664074|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
664075|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
664076|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
664077|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
664078|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
664079|NCT01160848|O3|Outcome|Area Cleaned With Ethyl Alcohol Solution|
664080|NCT01160848|O2|Outcome|Area Cleaned With Saline|
664081|NCT01160848|O1|Outcome|Part 1: Area Cleaned With Saline and Occluded With Tegaderm|
664087|NCT01161121|B1|Baseline|Adenosine, Regadenoson|Each patient underwent standard intravenous adenosine infusion (140mcg/kg/min) with invasive pressure recordings for 2 min, or until maximal hyperemia occurred. Five minutes after return to baseline hemodynamics, a single intravenous bolus of 0.4 mg regadenoson was administered, and pressures were recorded for 5 min. FFR values were compared by linear regression and Bland-Altman analysis.
664110|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664088|NCT01161121|P1|Participant Flow|Adenosine Then Regadenoson|"Adenosine infusion will be compared to Regadenoson for efficacy and safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. All patients to receive Adenosine infusion followed by Regadenoson IV bolus upon return of coronary flow velocity to 15% of pre-dose value.
Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia.
Regadenoson : Administration of IV regadenoson bolus 0.4 mg/5 mls over 10 seconds followed by a 5 cc NS saline flush"
664089|NCT01161121|O2|Outcome|Regadenoson|"Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush.
regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
664090|NCT01161121|O1|Outcome|Adenosine|"Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.
Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia"
664091|NCT01161121|O2|Outcome|Regadenosine|With bolus infusion of 0.4 mg
664092|NCT01161121|O1|Outcome|Adenosine|With infusion of 140 mcg/kg/min
664093|NCT01161121|O2|Outcome|Regadenoson|"Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush.
regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
664094|NCT01161121|O1|Outcome|Adenosine|"Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.
Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia"
664095|NCT01161121|E2|Reported Event|Regadenoson|"Once the mean coronary flow velocity returns to within 15% pre-dose value then Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml. Then, a 5 cc saline flush will be administered.
regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
664096|NCT01161121|E1|Reported Event|Adenosine|"Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.
Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia
adenosine : Measuring FFR and Coronary Flow Reserve after administration of IV adenosine 140 mcg/kg/min for 2 minutes.
regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
664097|NCT01161160|B4|Baseline|Total|Total of all reporting groups
664098|NCT01161160|B3|Baseline|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664099|NCT01161160|B2|Baseline|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664100|NCT01161160|B1|Baseline|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664101|NCT01161160|P3|Participant Flow|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664102|NCT01161160|P2|Participant Flow|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664103|NCT01161160|P1|Participant Flow|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664104|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664105|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664106|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664525|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
664107|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664108|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664109|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664111|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664112|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664113|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664114|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664115|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664116|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664117|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664118|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664119|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664120|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664121|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664122|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664123|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664124|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664125|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664126|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664127|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664128|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664129|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664130|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664131|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664132|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664526|NCT01168726|E3|Reported Event|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
664133|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664134|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664135|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664496|NCT01168674|E2|Reported Event|Ziprasidone|Active ziprasidone administered double-blind.
664136|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664137|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664138|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664139|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664140|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664141|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664142|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664143|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664144|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664145|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664146|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664147|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664148|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664149|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664150|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664151|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664152|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664153|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664154|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664155|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664156|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664157|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664158|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664159|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664160|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664497|NCT01168674|E1|Reported Event|Placebo|Placebo administered double-blind.
664161|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664162|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664163|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664164|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664165|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664166|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664167|NCT01161160|O3|Outcome|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664168|NCT01161160|O2|Outcome|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664169|NCT01161160|O1|Outcome|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664170|NCT01161160|E3|Reported Event|Arepanrix Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664171|NCT01161160|E2|Reported Event|Pandemrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664172|NCT01161160|E1|Reported Event|Arepanrix 1/2 Group|Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
664173|NCT01161173|B1|Baseline|Cohort|Participants in the observational cohort received second-line therapy with Tarceva. At the time of discontinuation of Tarceva, a third-line chemotherapy or best supportive care were initiated as appropriate.
664174|NCT01161173|P1|Participant Flow|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
664175|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
664176|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
664177|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
664178|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
664179|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
664180|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
664181|NCT01161173|E1|Reported Event|Erlotinib|"Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
Erlotinib: Erlotinib was provided in the retail versions of the product."
664182|NCT01161225|B4|Baseline|Total|Total of all reporting groups
664292|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664893|NCT01169675|E4|Reported Event|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
664183|NCT01161225|B3|Baseline|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664184|NCT01161225|B2|Baseline|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664267|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation
Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
664185|NCT01161225|B1|Baseline|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664186|NCT01161225|P3|Participant Flow|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664187|NCT01161225|P2|Participant Flow|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664188|NCT01161225|P1|Participant Flow|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664189|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664190|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664191|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664192|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders
664193|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program
664194|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program.
664195|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664196|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664197|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664428|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664198|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664199|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664268|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
664200|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664201|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664202|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664203|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664204|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664205|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664206|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664207|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664208|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664209|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months
664243|NCT01167192|B1|Baseline|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664210|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664211|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664212|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664269|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation
Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
664213|NCT01161225|E3|Reported Event|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664214|NCT01161225|E2|Reported Event|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664215|NCT01161225|E1|Reported Event|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
664216|NCT01167140|B1|Baseline|Group 1|
664217|NCT01167140|P1|Participant Flow|Treatment Group|
664218|NCT01167140|O1|Outcome|Treatment Group|
664219|NCT01167140|O1|Outcome|Treatment Group|
664220|NCT01167140|O1|Outcome|Treatment Group|
664221|NCT01167140|E1|Reported Event|Treatment Group|
664222|NCT01167153|B3|Baseline|Total|Total of all reporting groups
664223|NCT01167153|B2|Baseline|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664224|NCT01167153|B1|Baseline|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664225|NCT01167153|P2|Participant Flow|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664226|NCT01167153|P1|Participant Flow|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664227|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664228|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664229|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664230|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664231|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664232|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664233|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664234|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664235|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664236|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664237|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664238|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664239|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664240|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664241|NCT01167153|E2|Reported Event|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664242|NCT01167153|E1|Reported Event|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
664807|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
664244|NCT01167192|P1|Participant Flow|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664245|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664246|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664299|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664247|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664248|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664249|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664250|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664251|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664252|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664253|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664254|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664255|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664256|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664257|NCT01167192|E1|Reported Event|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.
Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.
Recommended mastectomy
Recommended adjuvant chemotherapy
-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
664258|NCT01167257|B3|Baseline|Total|Total of all reporting groups
664259|NCT01167257|B2|Baseline|Control Arm|"Normal saline 50 mL in single intravesical instillation
Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
664260|NCT01167257|B1|Baseline|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80mg/40ml) in single intravesical instillation
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
664261|NCT01167257|P2|Participant Flow|Control Arm|"Normal saline 50ml in single intravesical instillation
Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
664894|NCT01169675|E3|Reported Event|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
664262|NCT01167257|P1|Participant Flow|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
664263|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation
Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
664264|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
664265|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation
Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
664266|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
664498|NCT01168687|B3|Baseline|Total|Total of all reporting groups
664270|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 Ll water) in single intravesical instillation, one time treatment at the treatment day"
664271|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation
Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
664272|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
664273|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation
Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
664274|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10ml in Liposome 80 mg/40 mL) in single intravesical instillation
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
664275|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation
Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
664276|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
664277|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation
Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
664278|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
664279|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation
Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
664280|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
664281|NCT01167257|E2|Reported Event|Control Arm|"Normal saline 50 mL in single intravesical instillation
Normal saline instillation'
Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
664282|NCT01167257|E1|Reported Event|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation
Liposome encapsulated botulinum toxin A'
Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
664283|NCT01167881|B3|Baseline|Total|Total of all reporting groups
664284|NCT01167881|B2|Baseline|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664285|NCT01167881|B1|Baseline|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664286|NCT01167881|P2|Participant Flow|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664287|NCT01167881|P1|Participant Flow|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664288|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664289|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664290|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664291|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664293|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664294|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664295|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664296|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664297|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664298|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664300|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664301|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664302|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664303|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664304|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664305|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664306|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.
Glimepiride: 1-4 mg once daily
Placebo: Placebo matching Empagliflozin"
664307|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.
Empagliflozin: 25 mg once daily
Placebo: Placebo matching Glimepiride"
664308|NCT01167881|E2|Reported Event|Glimepiride|Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
664309|NCT01167881|E1|Reported Event|Empa 25mg|Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
664310|NCT01168024|B3|Baseline|Total|Total of all reporting groups
664311|NCT01168024|B2|Baseline|Standard of Care|"Peri-procedural hydration with isotonic saline or sodium bicarbonate for at least 2 hours prior to the procedure and 6-12 hours post-procedure.
Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate."
664312|NCT01168024|B1|Baseline|CINCOR™ System Treatment|"Use of the CINCOR™ System and CCS-1 device during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.
CINCOR™ System and CCS-1: Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media
Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate."
664313|NCT01168024|P2|Participant Flow|Standard of Care Plus Peri-procedural Hydration|Peri-procedural hydration utilized prior to standard of care PCI.
664314|NCT01168024|P1|Participant Flow|CINCOR™ System and CCS-1|Use of the CINCOR™ System and CCS-1 device during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.
664315|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
664316|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
664317|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
664318|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
664319|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
664320|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
664321|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
664322|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
664323|NCT01168024|E2|Reported Event|Control|Peri-procedure hydration
664324|NCT01168024|E1|Reported Event|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
664325|NCT01168232|B1|Baseline|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
664326|NCT01168232|P1|Participant Flow|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
664327|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
664328|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
664329|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
664330|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
664524|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
664331|NCT01168232|E1|Reported Event|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
664332|NCT01168349|B1|Baseline|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664333|NCT01168349|P1|Participant Flow|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664334|NCT01168349|O9|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664462|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664335|NCT01168349|O8|Outcome|Chronic Lymphocytic Leukemia Participants|Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664336|NCT01168349|O7|Outcome|Hodgkin's Lymphoma Participants|Hodgkin’s lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664337|NCT01168349|O6|Outcome|Non-Hodgkin's Lymphoma Participants|Non-Hodgkin’s lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664338|NCT01168349|O5|Outcome|Multiple Myeloma Participants|Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664339|NCT01168349|O4|Outcome|Ovary Cancer Participants|Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664340|NCT01168349|O3|Outcome|Colon/Rectum Cancer Participants|Colon/rectum cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664341|NCT01168349|O2|Outcome|Breast Cancer Participants|Breast cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664342|NCT01168349|O1|Outcome|Lung Cancer Participants|Lung cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664343|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664344|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664345|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664346|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664347|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664348|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664349|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664350|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664351|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664352|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664353|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664354|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664691|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664355|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664356|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664357|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664358|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664359|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664360|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664361|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664362|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664363|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664364|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664365|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664366|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664367|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664368|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664369|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664808|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
664370|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664371|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664372|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664373|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664463|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664374|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664375|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664376|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664377|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664378|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664379|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664380|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664381|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664382|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664383|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664384|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664385|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664386|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664387|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664388|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664389|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664390|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664391|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664392|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664393|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664394|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664395|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664396|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664397|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664398|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664399|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664400|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664401|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664402|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664464|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664403|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664404|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664405|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664406|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664407|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664408|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664409|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664410|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664411|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664412|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664413|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664414|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664415|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664416|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664417|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664418|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664419|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664420|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664421|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664422|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664423|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664424|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664425|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664426|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664427|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
664429|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664430|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664431|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664465|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664432|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664433|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia [CLL], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664434|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664435|NCT01168349|E3|Reported Event|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664436|NCT01168349|E2|Reported Event|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664437|NCT01168349|E1|Reported Event|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
664438|NCT01168427|B1|Baseline|Enrollment Cohort|Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
664439|NCT01168427|P1|Participant Flow|Enrollment Cohort|Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
664440|NCT01168427|O1|Outcome|Implant Cohort|Patient with Reveal device implanted
664441|NCT01168427|O1|Outcome|Implant Cohort|Patient with Reveal device implanted
664442|NCT01168427|E1|Reported Event|Implant Cohort|Patient with Reveal device implanted
664443|NCT01168596|B3|Baseline|Total|Total of all reporting groups
664444|NCT01168596|B2|Baseline|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664445|NCT01168596|B1|Baseline|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664446|NCT01168596|P2|Participant Flow|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664447|NCT01168596|P1|Participant Flow|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664448|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664449|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664450|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664451|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664452|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664453|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664454|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664455|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664456|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664457|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664458|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664459|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664460|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664461|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664466|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664467|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664468|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664469|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664470|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664471|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664472|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664473|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664474|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664475|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664476|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664477|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664478|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664479|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664480|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664481|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664482|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664483|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664484|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664485|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664486|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664487|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664488|NCT01168596|E2|Reported Event|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.
Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
664489|NCT01168596|E1|Reported Event|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Rasagiline : Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
664490|NCT01168674|B1|Baseline|All Study Participants|All participants were randomized to either placebo followed by ziprasidone crossover, or ziprsidone followed by placebo crossover.
664491|NCT01168674|P2|Participant Flow|Ziprasidone-washout-placebo|ziprasidone : Ziprasidone will be administered as a pill. The once-daily total daily dose will be 80-160 mg/d of ziprasidone. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Placebo, for another 6 weeks, using same dosing techniques.
664492|NCT01168674|P1|Participant Flow|Placebo-washout-ziprasidone|Placebo : The once-daily total daily dose will be 80-160 mg/d of the sugar pill. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Ziprazidone, for another 6 weeks, using same dosing techniques.
664493|NCT01168674|O1|Outcome|All Study Participants|All participants were randomized to either placebo followed by ziprasidone crossover, or ziprsidone followed by placebo crossover.
664494|NCT01168674|O2|Outcome|Ziprasidone|Subjects randomized to ziprasidone in either the initial or crossover phase.
664499|NCT01168687|B2|Baseline|Group B: Crossover Between High Dose Keppra and Placebo|"Group B: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.
Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period."
664500|NCT01168687|B1|Baseline|Group A: Crossover Between Low Dose Keppra and Placebo|Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.
664501|NCT01168687|P2|Participant Flow|Group B: Crossover Between High Dose Keppra and Placebo|"Group B: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.
Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period."
664502|NCT01168687|P1|Participant Flow|Group A: Crossover Between Low Dose Keppra and Placebo|Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.
664503|NCT01168687|O2|Outcome|All Subjects (n = 46) Levetiracetam|23 moderate social drinkers. 23 heavy social drinkers.
664504|NCT01168687|O1|Outcome|All Subjects (n = 46) Placebo|23 moderate social drinkers. 23 heavy social drinkers.
664505|NCT01168687|E2|Reported Event|All Subjects (n = 46) Levetiracetam|23 moderate social drinkers. 23 heavy social drinkers.
664506|NCT01168687|E1|Reported Event|All Subjects (n = 46) Placebo|23 moderate social drinkers. 23 heavy social drinkers.
664507|NCT01168726|B4|Baseline|Total|Total of all reporting groups
664508|NCT01168726|B3|Baseline|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
664509|NCT01168726|B2|Baseline|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
664510|NCT01168726|B1|Baseline|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
664511|NCT01168726|P3|Participant Flow|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
664512|NCT01168726|P2|Participant Flow|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
664513|NCT01168726|P1|Participant Flow|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
664514|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
664515|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
664516|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
664517|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
664518|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
664519|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
664520|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
664521|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
664522|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
664523|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
664527|NCT01168726|E2|Reported Event|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
664528|NCT01168726|E1|Reported Event|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
664529|NCT01168856|B3|Baseline|Total|Total of all reporting groups
664593|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664594|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664530|NCT01168856|B2|Baseline|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664531|NCT01168856|B1|Baseline|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664532|NCT01168856|P2|Participant Flow|Sustained Virological Response (SVR) Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved Sustained Virological Response (SVR), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test greater than or equal to (≥) 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664533|NCT01168856|P1|Participant Flow|Resistance Monitoring Arm|Participants enrolled into this arm were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664534|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV20536 [NCT00869661], WV21913 [NCT01331850], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], NP28266 [NCT01628094]. None of the enrolled patients had developed MCB-associated resistant mutation(s) in donor protocol. Participants were monitored up to 18 months.
664535|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
664536|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in the following donor protocol: NP28266 [NCT01628094]. Patients had developed STV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
664537|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
664538|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
664539|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
664540|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
664684|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664541|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664595|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664596|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664542|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664543|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664544|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664545|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664546|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664547|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664548|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664549|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664550|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664551|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664552|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664597|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664598|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664553|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664554|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664555|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664556|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664557|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664558|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664559|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664560|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
664561|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664628|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664562|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664599|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664600|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664601|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664602|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664563|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664564|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664565|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664566|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664567|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664568|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664569|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664681|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664685|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664570|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664571|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664603|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664572|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664573|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664574|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664575|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664576|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664577|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664578|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664579|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664580|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664604|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664581|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664582|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664583|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664584|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664585|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664586|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
664587|NCT01168856|E2|Reported Event|SVR Durability Monitoring Arm|Participants enrolled into this study were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had Achieved Sustained Virological Response (SVR-24), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test more than or equal to (≥) 20 weeks after the last dose of study medication.
664805|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
664588|NCT01168856|E1|Reported Event|Resistance Monitoring Arm|Participants enrolled into this study were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations.
664589|NCT01168934|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 50 mg IV first and crizotinib 250 mg oral first.
664590|NCT01168934|P2|Participant Flow|Crizotinib 250 mg Oral First, Then Crizotinib 50 mg IV|Single oral dose of crizotinib 250 mg IRT in first intervention period; and single IV dose of crizotinib 50 mg in second intervention period. A washout period of at least 14 days was maintained between each period.
664591|NCT01168934|P1|Participant Flow|Crizotinib 50 mg IV First, Then Crizotinib 250 mg Oral|Single intravenous (IV) dose of crizotinib 50 milligram (mg) in first intervention period; and single oral dose of crizotinib 250 mg immediate release tablet (IRT) in second intervention period. A washout period of at least 14 days was maintained between each period.
664592|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664947|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
664605|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664606|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664607|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664608|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664609|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664610|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664611|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664612|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664613|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664614|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664615|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664616|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664617|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664618|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664619|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664620|NCT01168934|E2|Reported Event|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
664621|NCT01168934|E1|Reported Event|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
664622|NCT01168973|B3|Baseline|Total|Total of all reporting groups
664623|NCT01168973|B2|Baseline|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664624|NCT01168973|B1|Baseline|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664625|NCT01168973|P2|Participant Flow|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664626|NCT01168973|P1|Participant Flow|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab drug product (DP) followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 milligrams per kilogram (mg/kg) administered intravenously.
Docetaxel: 75 milligrams per square meter (mg/m^2) (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664627|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664682|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664888|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
664629|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664630|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664631|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664632|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664633|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664634|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664635|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664636|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664637|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664638|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664639|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664640|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664641|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664642|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664643|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664644|NCT01168973|E2|Reported Event|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664683|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664645|NCT01168973|E1|Reported Event|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
Ramucirumab DP: 10 mg/kg administered intravenously.
Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
664646|NCT01168986|B4|Baseline|Total|Total of all reporting groups
664647|NCT01168986|B3|Baseline|No Intervention|Participants receive/perform no intervention
664648|NCT01168986|B2|Baseline|Exercise|"Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors"
664649|NCT01168986|B1|Baseline|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
664650|NCT01168986|P3|Participant Flow|No Intervention|Participants receive/perform no intervention
664651|NCT01168986|P2|Participant Flow|Exercise|"Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors"
664652|NCT01168986|P1|Participant Flow|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
664653|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
664948|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
664654|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors"
664655|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
664656|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
664657|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors"
664658|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
664659|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
664660|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors"
664661|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
664662|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
664663|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors"
664664|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
664665|NCT01168986|E3|Reported Event|No Intervention|Participants receive/perform no intervention
664666|NCT01168986|E2|Reported Event|Exercise|"Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors"
664667|NCT01168986|E1|Reported Event|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
664668|NCT01168999|B5|Baseline|Total|Total of all reporting groups
664669|NCT01168999|B4|Baseline|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664670|NCT01168999|B3|Baseline|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664671|NCT01168999|B2|Baseline|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664672|NCT01168999|B1|Baseline|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664673|NCT01168999|P4|Participant Flow|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664674|NCT01168999|P3|Participant Flow|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664675|NCT01168999|P2|Participant Flow|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664676|NCT01168999|P1|Participant Flow|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664677|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664678|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664679|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664680|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664686|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664687|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664688|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664689|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664690|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664692|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664693|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664694|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664695|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664696|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664697|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664698|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664699|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664700|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664701|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664702|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664703|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664704|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664705|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664706|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664707|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664708|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664709|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664710|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664711|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664712|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664713|NCT01168999|E4|Reported Event|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
664714|NCT01168999|E3|Reported Event|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
664715|NCT01168999|E2|Reported Event|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
664716|NCT01168999|E1|Reported Event|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
664717|NCT01169038|B1|Baseline|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD
**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
664718|NCT01169038|P1|Participant Flow|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD
**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
664719|NCT01169038|O1|Outcome|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD
**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
664889|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
664720|NCT01169038|E1|Reported Event|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD
**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
664721|NCT01169064|B3|Baseline|Total|Total of all reporting groups
664722|NCT01169064|B2|Baseline|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
664723|NCT01169064|B1|Baseline|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver
Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
664724|NCT01169064|P2|Participant Flow|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
664725|NCT01169064|P1|Participant Flow|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver
Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
664726|NCT01169064|O2|Outcome|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
664727|NCT01169064|O1|Outcome|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver
Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
664728|NCT01169064|O2|Outcome|Cloth Dressing|
664729|NCT01169064|O1|Outcome|Silver Dressing|
664730|NCT01169064|O2|Outcome|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
664731|NCT01169064|O1|Outcome|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver
Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
664732|NCT01169064|E2|Reported Event|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
No adverse events"
664733|NCT01169064|E1|Reported Event|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver
Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days
No adverse events"
664734|NCT01169103|B3|Baseline|Total|Total of all reporting groups
664735|NCT01169103|B2|Baseline|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
664736|NCT01169103|B1|Baseline|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
664737|NCT01169103|P2|Participant Flow|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
664738|NCT01169103|P1|Participant Flow|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
664739|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
664740|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
664741|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
664742|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
664743|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
664744|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
664745|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
664806|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
664890|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
664746|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
664747|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
664748|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
664749|NCT01169103|E2|Reported Event|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
664750|NCT01169103|E1|Reported Event|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.
recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
664751|NCT01169311|B1|Baseline|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects undergoing hemorrhoidopexy with HEEA stapler
664752|NCT01169311|P1|Participant Flow|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
664753|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
664754|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
664755|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
664756|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
664757|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
664758|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
664759|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
664760|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
664761|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
664762|NCT01169311|E1|Reported Event|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects undergoing hemorrhoidopexy with HEEA stapler
664763|NCT01169467|B3|Baseline|Total|Total of all reporting groups
664764|NCT01169467|B2|Baseline|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
664765|NCT01169467|B1|Baseline|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
664766|NCT01169467|P2|Participant Flow|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
664767|NCT01169467|P1|Participant Flow|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
664768|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
664769|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
664770|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
664771|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
664772|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
664773|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
664774|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
664775|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
664776|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
664777|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
664778|NCT01169467|E2|Reported Event|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
664779|NCT01169467|E1|Reported Event|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
664780|NCT01169493|B7|Baseline|Total|Total of all reporting groups
664781|NCT01169493|B6|Baseline|RV DDD-40 to Bi-V DDD-40 to VVI-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664782|NCT01169493|B5|Baseline|RV DDD-40 to VVI-40 to Bi-V DDD-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664783|NCT01169493|B4|Baseline|Bi-V DDD-40 to RV DDD-40 to VVI-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664784|NCT01169493|B3|Baseline|Bi-V DDD-40 to VVI-40 to RV DDD-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664785|NCT01169493|B2|Baseline|VVI-40 to Bi-V DDD-40 to RV DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664786|NCT01169493|B1|Baseline|VVI-40 to RV DDD-40 to Bi-V DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664787|NCT01169493|P6|Participant Flow|RV DDD-40 to Bi-V DDD-40 to VVI-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664788|NCT01169493|P5|Participant Flow|RV DDD-40 to VVI-40 to Bi-V DDD-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664789|NCT01169493|P4|Participant Flow|Bi-V DDD-40 to RV DDD-40 to VVI-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664790|NCT01169493|P3|Participant Flow|Bi-V DDD-40 to VVI-40 to RV DDD-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2.
Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3.
Period 3: Participants assigned to RV DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664791|NCT01169493|P2|Participant Flow|VVI-40 to Bi-V DDD-40 to RV DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.
Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3.
Period 3: Participants assigned to RV DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664792|NCT01169493|P1|Participant Flow|VVI-40 to RV DDD-40 to Bi-V DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.
Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3.
Period 3: Participants assigned to Bi-V DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
664793|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
664794|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
664795|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
664796|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
664797|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
664798|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
664799|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
664800|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
664801|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
664802|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
664803|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
664804|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
664809|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
664810|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
664811|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
664812|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
664813|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
664814|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
664815|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
664816|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
664817|NCT01169493|E3|Reported Event|Bi-V DDD-40|Bi-V DDD-40: ICD programmed to Bi-V pacing at a lower rate of 40
664818|NCT01169493|E2|Reported Event|RV DDD-40|RV DDD-40: ICD programmed to DDD-40, RV only pacing with an AV interval producing QRS fusion on surface EKG.
664819|NCT01169493|E1|Reported Event|VVI-40|VVI-40: Pacing mode set to VVI-40, RV only pacing
664820|NCT01169519|B1|Baseline|Sildenafil|"Pharmacokinetic and hemodynamic evaluation following sildenafil administration
Sildenafil by injection : Sildenafil 0.45mg/kg by injection over 20min
Sildenafil by injection : Sildenafil 0.25mg/kg injection over 20min
Sildenafil by injection : Sildenafil 0.35mg/kg by injection over 20min
Sildenafil by injection : Sildenafil 0.125mg/kg injection over 20min"
664821|NCT01169519|P1|Participant Flow|Baseline/Sildenafil|Assessment of baseline hemodynamics followed by sildenafil infusion with repeat assessment of hemodynamics
664822|NCT01169519|O2|Outcome|Sildenafil|"Pharmacokinetic and hemodynamic evaluation following sildenafil administration
Sildenafil by injection : Sildenafil 0.45mg/kg by injection over 20min
Sildenafil by injection : Sildenafil 0.25mg/kg injection over 20min
Sildenafil by injection : Sildenafil 0.35mg/kg by injection over 20min
Sildenafil by injection : Sildenafil 0.125mg/kg injection over 20min"
664823|NCT01169519|O1|Outcome|Baseline|Assessment of baseline hemodynamics
664824|NCT01169519|O4|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.25mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusionplasma concentration
664825|NCT01169519|O3|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.45mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
664826|NCT01169519|O2|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.35mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
664827|NCT01169519|O1|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.125mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
664828|NCT01169519|E4|Reported Event|Dose = 0.45mg/kg|Subjects receiving a sildenafil dose of 0.45mg/kg IV over 20 min
664829|NCT01169519|E3|Reported Event|Dose = 0.35mg/kg|Subjects receiving a sildenafil dose of 0.35mg/kg IV over 20 min
664830|NCT01169519|E2|Reported Event|Dose = 0.25mg/kg|Subjects receiving a sildenafil dose of 0.25mg/kg IV over 20 min
664831|NCT01169519|E1|Reported Event|Dose = 0.125mg/kg|Subjects receiving a sildenafil dose of 0.125mg/kg IV over 20 min
664832|NCT01169558|B1|Baseline|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
664833|NCT01169558|P1|Participant Flow|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
664834|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
664835|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
664836|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
664837|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
664838|NCT01169558|E1|Reported Event|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
664839|NCT01169610|B1|Baseline|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
664840|NCT01169610|P1|Participant Flow|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
664891|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
664892|NCT01169675|E5|Reported Event|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
664841|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
664842|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
664843|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
664949|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
664844|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
664845|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
664846|NCT01169610|E1|Reported Event|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
664847|NCT01169649|B1|Baseline|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
664848|NCT01169649|P1|Participant Flow|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
664849|NCT01169649|O1|Outcome|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
664850|NCT01169649|E1|Reported Event|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
664851|NCT01169675|B6|Baseline|Total|Total of all reporting groups
664852|NCT01169675|B5|Baseline|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
664853|NCT01169675|B4|Baseline|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
664854|NCT01169675|B3|Baseline|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
664855|NCT01169675|B2|Baseline|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
664856|NCT01169675|B1|Baseline|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
664857|NCT01169675|P5|Participant Flow|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
664858|NCT01169675|P4|Participant Flow|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
664859|NCT01169675|P3|Participant Flow|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
664860|NCT01169675|P2|Participant Flow|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
664861|NCT01169675|P1|Participant Flow|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
664862|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
664863|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
664864|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
664865|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
664866|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
664867|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
664868|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
664869|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
664870|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
664871|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
664872|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
664873|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
664874|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
664875|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
664876|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
664877|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
664878|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
664879|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
664880|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
664881|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
664882|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
664883|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
664884|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
664885|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
664886|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
664887|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
664895|NCT01169675|E2|Reported Event|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
664896|NCT01169675|E1|Reported Event|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
664897|NCT01169701|B3|Baseline|Total|Total of all reporting groups
664950|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
664898|NCT01169701|B2|Baseline|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664899|NCT01169701|B1|Baseline|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664900|NCT01169701|P2|Participant Flow|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664901|NCT01169701|P1|Participant Flow|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664902|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664903|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664904|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664905|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664906|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664907|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664908|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664909|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664910|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664911|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664912|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664913|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664914|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664915|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664943|NCT01169779|B1|Baseline|Placebo|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
664916|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664951|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
664917|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664918|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664919|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664920|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664921|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664922|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664923|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664924|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664925|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664926|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664927|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664928|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664929|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664930|NCT01169701|E2|Reported Event|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
664931|NCT01169701|E1|Reported Event|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
664932|NCT01169753|B3|Baseline|Total|Total of all reporting groups
664933|NCT01169753|B2|Baseline|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
664934|NCT01169753|B1|Baseline|Placebo|Oral placebo every morning for 2 weeks.
664935|NCT01169753|P2|Participant Flow|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
664936|NCT01169753|P1|Participant Flow|Placebo|Oral placebo every morning for 2 weeks.
664937|NCT01169753|O2|Outcome|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
664938|NCT01169753|O1|Outcome|Placebo|Oral placebo every morning for 2 weeks.
664939|NCT01169753|E2|Reported Event|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
664940|NCT01169753|E1|Reported Event|Placebo|Oral placebo every morning for 2 weeks.
664941|NCT01169779|B3|Baseline|Total|Total of all reporting groups
664942|NCT01169779|B2|Baseline|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
664944|NCT01169779|P2|Participant Flow|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
664945|NCT01169779|P1|Participant Flow|Placebo|1-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
664946|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
664955|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
664956|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
664957|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
664958|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
664959|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
664960|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
664961|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
664962|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
664963|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
664964|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
664965|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
664966|NCT01169779|E2|Reported Event|Lixisenatide|1-step initiation regimen of lixisenatide.
664967|NCT01169779|E1|Reported Event|Placebo|1-step initiation regimen of volume matching placebo.
664968|NCT01169987|B1|Baseline|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
664969|NCT01169987|P1|Participant Flow|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
664970|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
664971|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
664972|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
664973|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
664974|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
664975|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
664976|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
664977|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
664978|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
664979|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
664980|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
664981|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
664982|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
664983|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
665114|NCT01170273|P1|Participant Flow|Placebo Arm|"placebo capsule
placebo: placebo tablet
participants received one daily tablet containing placebo for 9 months"
664984|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
664985|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
664986|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
664987|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
664988|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
664989|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
664990|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
664991|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
664992|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
664993|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
664994|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
664995|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
664996|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
664997|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
664998|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
664999|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
665000|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
665001|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
665054|NCT01170117|B3|Baseline|Total|Total of all reporting groups
665111|NCT01170273|B2|Baseline|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily
vitamin D: cholecalciferol
participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
665002|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
665057|NCT01170117|P2|Participant Flow|Olanzapine|"Group receiving olanzapine
Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
665003|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
665004|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
665005|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
665006|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
665007|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
665008|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
665009|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
665010|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
665011|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
665012|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
665013|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
665014|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
665015|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
665016|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
665017|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
665018|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
665019|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
665020|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
665021|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
665058|NCT01170117|P1|Participant Flow|Placebo|"Control group receiving placebo
Placebo: Control Group will receive placebo pill."
665318|NCT01170546|E2|Reported Event|SP (Squat Press)|plate-loaded squat press
665022|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
665023|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
665024|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
665025|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
665026|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
665027|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
665028|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
665029|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
665030|NCT01169987|O1|Outcome|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
665031|NCT01169987|E1|Reported Event|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
665032|NCT01170039|B3|Baseline|Total|Total of all reporting groups
665033|NCT01170039|B2|Baseline|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
665034|NCT01170039|B1|Baseline|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
665035|NCT01170039|P2|Participant Flow|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
665036|NCT01170039|P1|Participant Flow|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
665037|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
665038|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
665039|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
665040|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
665041|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
665042|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
665043|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
665044|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
665045|NCT01170039|E2|Reported Event|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
665046|NCT01170039|E1|Reported Event|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
665047|NCT01170091|B1|Baseline|Patients With Restless Legs Syndrome (RLS)|Patients with RLS who had initiated with Mirapex
665048|NCT01170091|P1|Participant Flow|Mirapex|Patients with RLS who had initiated with Mirapex
665049|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
665050|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
665051|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
665052|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
665053|NCT01170091|E1|Reported Event|Patients With Restless Legs Syndrome (RLS)|Patients with RLS who had initiated with Mirapex
665055|NCT01170117|B2|Baseline|Olanzapine|"Group receiving olanzapine
Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
665056|NCT01170117|B1|Baseline|Placebo|"Control group receiving placebo
Placebo: Control Group will receive placebo pill"
665319|NCT01170546|E1|Reported Event|KLCIR|plate-loaded kneeling leg curl with internal rotation
665059|NCT01170117|O2|Outcome|Olanzapine|"Group receiving olanzapine
Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
665060|NCT01170117|O1|Outcome|Placebo|"Control group receiving placebo
Placebo: Control Group will receive placebo pill."
665061|NCT01170117|O2|Outcome|Olanzapine|"Group receiving olanzapine
Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
665062|NCT01170117|O1|Outcome|Placebo|"Control group receiving placebo
Placebo: Control Group will receive placebo pill."
665063|NCT01170117|E2|Reported Event|Olanzapine|"Group receiving olanzapine
Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients."
665064|NCT01170117|E1|Reported Event|Placebo|"Control group receiving placebo
Placebo: Control Group will receive placebo pill."
665065|NCT01170208|B4|Baseline|Total|Total of all reporting groups
665066|NCT01170208|B3|Baseline|Group III|Type 2 diabetes treated with biphasic insulin.
665067|NCT01170208|B2|Baseline|Group II|Type 2 diabetes treated with basalbolus therapy
665068|NCT01170208|B1|Baseline|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
665069|NCT01170208|P3|Participant Flow|Group III|Type 2 diabetes treated with biphasic insulin.
665070|NCT01170208|P2|Participant Flow|Group II|Type 2 diabetes treated with basalbolus therapy
665071|NCT01170208|P1|Participant Flow|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
665072|NCT01170208|O3|Outcome|Group III|Type 2 diabetes treated with biphasic insulin
665073|NCT01170208|O2|Outcome|Group II|Type 2 diabetes treated with basal bolus therapy
665074|NCT01170208|O1|Outcome|Group I|Type 1 diabetes treated with basal-bolus insulin the
665075|NCT01170208|E3|Reported Event|Group III|Type 2 diabetes treated with biphasic insulin.
665076|NCT01170208|E2|Reported Event|Group II|Type 2 diabetes treated with basalbolus therapy
665077|NCT01170208|E1|Reported Event|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
665078|NCT01170221|B3|Baseline|Total|Total of all reporting groups
665079|NCT01170221|B2|Baseline|Linezolid|Oral linezolid 600 mg twice daily for 10 days
665080|NCT01170221|B1|Baseline|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
665081|NCT01170221|P2|Participant Flow|Linezolid|Oral linezolid 600 mg twice daily for 10 days
665082|NCT01170221|P1|Participant Flow|Tedizolid Phosphate|Oral Tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
665083|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
665084|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
665085|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
665086|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
665087|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
665088|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
665089|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
665090|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
665091|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
665092|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
665093|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
665094|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
665095|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
665096|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
665097|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
665098|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
665099|NCT01170221|E2|Reported Event|Linezolid|Oral linezolid 600 mg twice daily for 10 days
665100|NCT01170221|E1|Reported Event|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
665101|NCT01170247|B3|Baseline|Total|Total of all reporting groups
665102|NCT01170247|B2|Baseline|Intramuscular Ketamine|
665103|NCT01170247|B1|Baseline|Intranasal Ketamine|
665104|NCT01170247|P2|Participant Flow|Intramuscular Ketamine|
665105|NCT01170247|P1|Participant Flow|Intranasal Ketamine|Enrolled 2 patients over 6 month period
665106|NCT01170247|O2|Outcome|Intramuscular Ketamine|Ketamine: Intramuscular Ketamine
665107|NCT01170247|O1|Outcome|Intranasal Ketamine|Ketamine: Intranasal Ketamine (100 mg/mL)
665108|NCT01170247|E2|Reported Event|Intramuscular Ketamine|None report
665109|NCT01170247|E1|Reported Event|Intranasal Ketamine|None Reported
665110|NCT01170273|B3|Baseline|Total|Total of all reporting groups
665112|NCT01170273|B1|Baseline|Placebo Arm|"placebo capsule
placebo: placebo tablet
participants received one daily tablet containing placebo for 9 months"
665113|NCT01170273|P2|Participant Flow|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily
vitamin D: cholecalciferol
participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
665115|NCT01170273|O2|Outcome|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily
vitamin D: cholecalciferol
participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
665116|NCT01170273|O1|Outcome|Placebo Arm|"placebo capsule
placebo: placebo tablet
participants received one daily tablet containing placebo for 9 months"
665117|NCT01170273|E2|Reported Event|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily
vitamin D: cholecalciferol
participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
665118|NCT01170273|E1|Reported Event|Placebo Arm|"placebo capsule
placebo: placebo tablet
participants received one daily tablet containing placebo for 9 months"
665119|NCT01164137|B3|Baseline|Total|Total of all reporting groups
665120|NCT01164137|B2|Baseline|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665121|NCT01164137|B1|Baseline|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665122|NCT01164137|P2|Participant Flow|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665123|NCT01164137|P1|Participant Flow|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665124|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665125|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665126|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665127|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665128|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665129|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665130|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665131|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665132|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665133|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665134|NCT01164137|E2|Reported Event|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665135|NCT01164137|E1|Reported Event|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
665136|NCT01164475|B3|Baseline|Total|Total of all reporting groups
665137|NCT01164475|B2|Baseline|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665138|NCT01164475|B1|Baseline|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665572|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665282|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
665479|NCT01171612|B1|Baseline|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
665139|NCT01164475|P2|Participant Flow|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665140|NCT01164475|P1|Participant Flow|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (greater than or equal to [>=] 5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665141|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665142|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665143|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665144|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665145|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665146|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665147|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665148|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665283|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
665340|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
665149|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665150|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665151|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665152|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665153|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665154|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665155|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665156|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665157|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665158|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665159|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665160|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665161|NCT01164475|E2|Reported Event|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665162|NCT01164475|E1|Reported Event|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
665163|NCT01164501|B4|Baseline|Total|Total of all reporting groups
665164|NCT01164501|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
665165|NCT01164501|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
665166|NCT01164501|B1|Baseline|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
665167|NCT01164501|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
665168|NCT01164501|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
665169|NCT01164501|P1|Participant Flow|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
665170|NCT01164501|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
665171|NCT01164501|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
665172|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
665173|NCT01164501|O2|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
665174|NCT01164501|O1|Outcome|Placebo|Placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
665175|NCT01164501|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
665176|NCT01164501|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
665177|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
665178|NCT01164501|O2|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
665179|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
665180|NCT01164501|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
665181|NCT01164501|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
665182|NCT01164501|E1|Reported Event|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
665183|NCT01164579|B4|Baseline|Total|Total of all reporting groups
665184|NCT01164579|B3|Baseline|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665328|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665573|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665185|NCT01164579|B2|Baseline|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665284|NCT01170390|O2|Outcome|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
665589|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665186|NCT01164579|B1|Baseline|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665187|NCT01164579|P3|Participant Flow|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665188|NCT01164579|P2|Participant Flow|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665189|NCT01164579|P1|Participant Flow|Tofacitinib (CP-690,550) Plus Methotrexate (MTX)|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665190|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665191|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665192|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665193|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665194|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665195|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665285|NCT01170390|O1|Outcome|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
665480|NCT01171612|P1|Participant Flow|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
665196|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665197|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665198|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665199|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665200|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665201|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665202|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665203|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665204|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665581|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665205|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665226|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665206|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665207|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665208|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665209|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665210|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665211|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665212|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665213|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665329|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665574|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665214|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665215|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665276|NCT01170390|B1|Baseline|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
665309|NCT01170546|P3|Participant Flow|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
665216|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665217|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665218|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665219|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665220|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665221|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665222|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665223|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665575|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665224|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665225|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665277|NCT01170390|P3|Participant Flow|Study Arm #2 (Aviane and Portia)|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
665310|NCT01170546|P2|Participant Flow|SP (Squat Press)|plate-loaded squat press
665311|NCT01170546|P1|Participant Flow|KLCIR|plate-loaded kneeling leg curl with internal rotation
665227|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665228|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665229|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665230|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665231|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665232|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665233|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665330|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665576|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665234|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665235|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665236|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665278|NCT01170390|P2|Participant Flow|Study Arm #1 (Aviane and Aviane)|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
665279|NCT01170390|P1|Participant Flow|All Participants|All participants were given a low dose oral contraceptive (Aviane) cyclically for 2 months
665237|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665238|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665239|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665240|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665241|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665242|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665243|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665244|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665245|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665246|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665280|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
665312|NCT01170546|O4|Outcome|Control|Control group
665313|NCT01170546|O3|Outcome|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
665314|NCT01170546|O2|Outcome|SP (Squat Press)|plate-loaded squat press
665247|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665248|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665249|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665250|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665251|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665252|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665253|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665254|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665255|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665256|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665281|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
665315|NCT01170546|O1|Outcome|KLCIR|plate-loaded kneeling leg curl with internal rotation
665316|NCT01170546|E4|Reported Event|Control|Control group
665317|NCT01170546|E3|Reported Event|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
665257|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665258|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665259|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665260|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665261|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665262|NCT01164579|E3|Reported Event|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665331|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665364|NCT01170663|E2|Reported Event|Placebo and Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² administered on Days 1, 8, and 15 of a 28-day cycle.
665263|NCT01164579|E2|Reported Event|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665264|NCT01164579|E1|Reported Event|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
665265|NCT01170364|B3|Baseline|Total|Total of all reporting groups
665266|NCT01170364|B2|Baseline|Placebo First, Then Sibutramine|Participants in this group were randomized to begin with 14 days of placebo, followed by 7 days of 15mg of sibutramine.
665267|NCT01170364|B1|Baseline|Sibutramine First, Then Placebo|Participants in this group were randomized to begin with 7 days of 15mg of sibutramine, followed by 14 days of placebo.
665268|NCT01170364|P2|Participant Flow|Placebo First, Then Sibutramine|This is a cross over design study. Participants in this arm begin with two weeks of placebo, followed by one week of 15mg of sibutramine
665269|NCT01170364|P1|Participant Flow|Sibutramine First, Then Placebo|This is a cross over design study. Participants in this arm begin with one week of 15mg sibutramine, followed by two weeks of placebo.
665270|NCT01170364|O2|Outcome|Placebo|In this arm, participants received placebo (for 15mg sibumtramine) for 7 days.
665271|NCT01170364|O1|Outcome|Sibutramine|In this arm, participants received sibutramine 15mg for 7 days
665272|NCT01170364|E2|Reported Event|Placebo|Participants who received a placebo capsule (matching sibutramine 15mg) every morning for 7 days.
665273|NCT01170364|E1|Reported Event|Sibutramine|Participants who received sibutramine 15mg capsule every morning for 7 days.
665274|NCT01170390|B3|Baseline|Total|Total of all reporting groups
665275|NCT01170390|B2|Baseline|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
665286|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
665287|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
665288|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
665289|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
665290|NCT01170390|E2|Reported Event|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
665291|NCT01170390|E1|Reported Event|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
665292|NCT01170533|B1|Baseline|All Study Participants|"This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).
The PPI could be omeprazole (first phase) or pantoprazole (second phase)."
665293|NCT01170533|P2|Participant Flow|Pantoprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
665332|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665294|NCT01170533|P1|Participant Flow|Omeprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).
665295|NCT01170533|O6|Outcome|Clopidogrel Only (Pantoprazole Phase)|Participants took clopidogrel only
665296|NCT01170533|O5|Outcome|Clopidogrel Only (Omeprazole Phase)|Participants took clopidogrel only
665297|NCT01170533|O4|Outcome|Pantoprazole Staggered|Participants took pantoprazole with clopidogrel staggered
665298|NCT01170533|O3|Outcome|Pantoprazole Concomitant|Participants took pantoprazole with clopidogrel concomitantly
665299|NCT01170533|O2|Outcome|Omeprazole Staggered|Participants took omeprazole with clopidogrel staggered
665300|NCT01170533|O1|Outcome|Omeprazole Concomitant|Participants took omeprazole with clopidogrel concomitantly
665301|NCT01170533|E2|Reported Event|Pantoprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
665302|NCT01170533|E1|Reported Event|Omeprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).
665303|NCT01170546|B5|Baseline|Total|Total of all reporting groups
665304|NCT01170546|B4|Baseline|Control|Control group
665305|NCT01170546|B3|Baseline|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
665306|NCT01170546|B2|Baseline|SP (Squat Press)|plate-loaded squat press
665307|NCT01170546|B1|Baseline|KLCIR|plate-loaded kneeling leg curl with internal rotation
665308|NCT01170546|P4|Participant Flow|Control|Control group
665320|NCT01170598|B1|Baseline|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665321|NCT01170598|P1|Participant Flow|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665322|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665323|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665324|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665325|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665326|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665327|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665363|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665458|NCT01171183|O1|Outcome|Placebo|Placebo: Placebo
665333|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665334|NCT01170598|E1|Reported Event|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
665335|NCT01170663|B3|Baseline|Total|Total of all reporting groups
665336|NCT01170663|B2|Baseline|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
665337|NCT01170663|B1|Baseline|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665338|NCT01170663|P2|Participant Flow|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
665339|NCT01170663|P1|Participant Flow|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 milligrams/kilogram (mg/kg) of ramucirumab (IMC-1121B) was administered by intravenous (IV) infusion on Days 1 and 15 in combination with 80 milligrams/square meter (mg/m²) paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665341|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665342|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
665343|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665344|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
665345|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665346|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665347|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665348|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665349|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665350|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665351|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665352|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
665353|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665354|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
665355|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665356|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
665357|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665358|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
665359|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665360|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
665361|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665362|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
665365|NCT01170663|E1|Reported Event|Ramucirumab and Paclitaxel|8 mg/kg ramucirumab (IMC1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
665366|NCT01170754|B3|Baseline|Total|Total of all reporting groups
665367|NCT01170754|B2|Baseline|Golytely 4 Liters|"Golytely 4 Liters
Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
665368|NCT01170754|B1|Baseline|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.
Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
665369|NCT01170754|P2|Participant Flow|Golytely 4 Liters|"Golytely 4 Liters
Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
665370|NCT01170754|P1|Participant Flow|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.
Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
665371|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters
Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
665372|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.
Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
665373|NCT01170754|E2|Reported Event|Golytely 4 Liters|"Golytely 4 Liters
Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
665374|NCT01170754|E1|Reported Event|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.
Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
665375|NCT01170884|B3|Baseline|Total|Total of all reporting groups
665376|NCT01170884|B2|Baseline|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
665377|NCT01170884|B1|Baseline|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
665378|NCT01170884|P2|Participant Flow|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
665379|NCT01170884|P1|Participant Flow|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
665380|NCT01170884|O2|Outcome|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
665381|NCT01170884|O1|Outcome|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
665382|NCT01170884|E2|Reported Event|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
665383|NCT01170884|E1|Reported Event|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
665384|NCT01170949|B3|Baseline|Total|Total of all reporting groups
665385|NCT01170949|B2|Baseline|Placebo|
665386|NCT01170949|B1|Baseline|Miltefosine|
665387|NCT01170949|P2|Participant Flow|Placebo|Week 1 – 50 mg miltefosine or placebo Week 2 – 100 mg miltefosine or placebo (1 capsule in the morning and one in the evening),if evidence of intolerability dose had to be reduced to 50 mg, those patients received 50 mg until the end of the treatment period Week 3 – 150 mg miltefosine or placebo (3 capsules, one in the morning, one at lunch and one in the evening) if evidence of intolerability dose had to be reduced to 100 mg, those patients received 100 mg until the end of the treatment period
665388|NCT01170949|P1|Participant Flow|Miltefosine|Week 1 – 50 mg miltefosine or placebo Week 2 – 100 mg miltefosine or placebo (1 capsule in the morning and one in the evening),if evidence of intolerability dose had to be reduced to 50 mg, those patients received 50 mg until the end of the treatment period Week 3 – 150 mg miltefosine or placebo (3 capsules, one in the morning, one at lunch and one in the evening) if evidence of intolerability dose had to be reduced to 100 mg, those patients received 100 mg until the end of the treatment period
665389|NCT01170949|O2|Outcome|Placebo|Placebo: Placebo
665390|NCT01170949|O1|Outcome|Miltefosine|Miltefosine: 50 or 100 or 150mg per day
665391|NCT01170949|E2|Reported Event|Placebo|
665392|NCT01170949|E1|Reported Event|Miltefosine|
665393|NCT01170962|B4|Baseline|Total|Total of all reporting groups
665394|NCT01170962|B3|Baseline|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665395|NCT01170962|B2|Baseline|Daclastavir (60mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665459|NCT01171183|O2|Outcome|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
665396|NCT01170962|B1|Baseline|Daclastavir (20mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665397|NCT01170962|P3|Participant Flow|Placebo: Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665481|NCT01171612|O3|Outcome|Complete Withdrawal|patients with aspirin oand/or clopidogrel, which stopped therapy > 5 days
665593|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665398|NCT01170962|P2|Participant Flow|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665399|NCT01170962|P1|Participant Flow|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665400|NCT01170962|O3|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665401|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665402|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665403|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665460|NCT01171183|O1|Outcome|Placebo|Placebo: Placebo
665404|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665421|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily up to 24 weeks. Participants continued to receive pegIFNα-2a and ribavirin, up to 48 weeks followed by a post treatment follow-up period of 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665477|NCT01171534|E2|Reported Event|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device
DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
665405|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665406|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665407|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy.
665408|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665409|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665410|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665577|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665411|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665412|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665472|NCT01171534|P1|Participant Flow|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.
Vessel loop: Vessel loops and staples for fasciotomy closure"
665473|NCT01171534|O2|Outcome|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device
DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
666026|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665413|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665414|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665415|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665416|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665417|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665461|NCT01171183|E2|Reported Event|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
665462|NCT01171183|E1|Reported Event|Placebo|Placebo: Placebo
665463|NCT01171521|B1|Baseline|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.
DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
665578|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665418|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665419|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665420|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665590|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665422|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665423|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665424|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665425|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665426|NCT01170962|O3|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665427|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665428|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665429|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665474|NCT01171534|O1|Outcome|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.
Vessel loop: Vessel loops and staples for fasciotomy closure"
665478|NCT01171534|E1|Reported Event|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.
Vessel loop: Vessel loops and staples for fasciotomy closure"
665430|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665431|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665432|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665433|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665434|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665579|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665435|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665436|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665437|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665591|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665438|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665439|NCT01170962|E3|Reported Event|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665440|NCT01170962|E2|Reported Event|Daclatasvir (60 mg): Prior Null and Partial Responders|Participant (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665441|NCT01170962|E1|Reported Event|Daclatasvir (20 mg): Prior Null and Partial Responders|Participant (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
665464|NCT01171521|P1|Participant Flow|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.
DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
665465|NCT01171521|O1|Outcome|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.
DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
665442|NCT01171118|B1|Baseline|Physostigmine/Placebo|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuouslyCapsaicin : 0.075% topical cream applicationPlacebo:We are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias (central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this.
665443|NCT01171118|P1|Participant Flow|Physostigmine vs. Placebo in Room Air vs. O2 During Sedation|"Each subject received the sedation protocol as described below:
Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Physostigmine (PS) vs. Placebo were randomized by DAYS. Then, on each day, subjects were randomized to receive oxygen or room air first or second. But each subject went through BOTH days and both oxygen and room air on each day.
There were eight total possible sequences."
665444|NCT01171118|O4|Outcome|Placebo/Room Air|"Each subject received the sedation protocol as described below:
Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm."
665445|NCT01171118|O3|Outcome|Physostigmine/Room Air|"Each subject received the sedation protocol as described below:
Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm."
665446|NCT01171118|O2|Outcome|Placebo/Oxygen|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute
665475|NCT01171534|O2|Outcome|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device
DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
665476|NCT01171534|O1|Outcome|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.
Vessel loop: Vessel loops and staples for fasciotomy closure"
666921|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
665447|NCT01171118|O1|Outcome|Physostigmine/Oxygen|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute
665448|NCT01171118|E4|Reported Event|Room Air|Subjects were assessed for two separate one hour periods of time -- one hour while breathing room air
665449|NCT01171118|E3|Reported Event|Oxygen|Subjects were assessed for two separate one hour periods of time -- one hour while breathing oxygen via a nasal cannula at 2 liters/minute
665450|NCT01171118|E2|Reported Event|Placebo|We are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias (central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep in OSA patients, have not been systematically studied during sedation in either normal subjects or OSA patients. The agent to be assessed in this study is physostigmine versus placebo.
665451|NCT01171118|E1|Reported Event|Physostigmine|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application
665452|NCT01171183|B3|Baseline|Total|Total of all reporting groups
665453|NCT01171183|B2|Baseline|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
665454|NCT01171183|B1|Baseline|Placebo|Placebo: Placebo
665455|NCT01171183|P2|Participant Flow|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
665456|NCT01171183|P1|Participant Flow|Placebo|Placebo: Placebo
665457|NCT01171183|O2|Outcome|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
665466|NCT01171521|O1|Outcome|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.
DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
665467|NCT01171521|E1|Reported Event|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.
DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
665468|NCT01171534|B3|Baseline|Total|Total of all reporting groups
665469|NCT01171534|B2|Baseline|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device
DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
665470|NCT01171534|B1|Baseline|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.
Vessel loop: Vessel loops and staples for fasciotomy closure"
665471|NCT01171534|P2|Participant Flow|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device
DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
665592|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665482|NCT01171612|O2|Outcome|Incomplete Withdrawal (Mantaining ASA, Clopidogrel Withdrawn)|Patients under dual antiplatelet therapy, wich maintain aspirin, and withdrawn clopidogrel 5 or more days
665483|NCT01171612|O1|Outcome|Not Withdrawal Antiplatelet Therapy|Patients wiht aspirin and/or clopidogrel withdrawal for 5 or more days
665484|NCT01171612|O1|Outcome|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
665485|NCT01171612|O1|Outcome|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
665486|NCT01171612|E1|Reported Event|Cardiac and Cerebrovascular Events|Adverse events registered independently related with antiplatelet therapy management
665487|NCT01171677|B3|Baseline|Total|Total of all reporting groups
665488|NCT01171677|B2|Baseline|Treatment as Usual|
665489|NCT01171677|B1|Baseline|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665490|NCT01171677|P2|Participant Flow|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665491|NCT01171677|P1|Participant Flow|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665492|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665493|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665523|NCT01171690|B2|Baseline|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
665580|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665494|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665495|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665505|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665496|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665497|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665498|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665499|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665500|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665501|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665571|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665502|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665503|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665504|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665506|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665507|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665508|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665509|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665510|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665511|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665512|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665513|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665514|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665515|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665516|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665517|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665518|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
665519|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665520|NCT01171677|E2|Reported Event|Treatment As Usual|
665521|NCT01171677|E1|Reported Event|Intensati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
665522|NCT01171690|B3|Baseline|Total|Total of all reporting groups
665524|NCT01171690|B1|Baseline|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
665525|NCT01171690|P2|Participant Flow|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
665526|NCT01171690|P1|Participant Flow|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
665527|NCT01171690|O2|Outcome|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
665528|NCT01171690|O1|Outcome|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
665529|NCT01171690|O2|Outcome|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
665530|NCT01171690|O1|Outcome|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
665588|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665531|NCT01171690|E2|Reported Event|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
665532|NCT01171690|E1|Reported Event|Teriparatide|"The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
There were no adverse events related to the use of teriparatide."
665533|NCT01171794|B3|Baseline|Total|Total of all reporting groups
665534|NCT01171794|B2|Baseline|Placebo|Visually identical placebo
665535|NCT01171794|B1|Baseline|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
665536|NCT01171794|P2|Participant Flow|Placebo|Visually identical placebo
665537|NCT01171794|P1|Participant Flow|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
665538|NCT01171794|O2|Outcome|Placebo|visually identical placebo
665539|NCT01171794|O1|Outcome|Ibuprofen|Ibuprofen: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
665540|NCT01171794|O2|Outcome|Placebo|visually identical placebo
665541|NCT01171794|O1|Outcome|Ibuprofen|Ibuprofen: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
665542|NCT01171794|E2|Reported Event|Placebo|visually identical placebo
665543|NCT01171794|E1|Reported Event|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
665544|NCT01171820|B3|Baseline|Total|Total of all reporting groups
665545|NCT01171820|B2|Baseline|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665546|NCT01171820|B1|Baseline|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665547|NCT01171820|P2|Participant Flow|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during percutaneous coronary intervention (PCI)
665548|NCT01171820|P1|Participant Flow|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665549|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665550|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665551|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665552|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665553|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665554|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665555|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665556|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665557|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665558|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665559|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665560|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665561|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665562|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665563|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665564|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665565|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665566|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665567|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665568|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665569|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665570|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665582|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665583|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665584|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665585|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665586|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665587|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665594|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665595|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665596|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665597|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665598|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665599|NCT01171820|E2|Reported Event|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
665600|NCT01171820|E1|Reported Event|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
665601|NCT01171924|B3|Baseline|Total|Total of all reporting groups
665602|NCT01171924|B2|Baseline|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
665603|NCT01171924|B1|Baseline|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
665604|NCT01171924|P2|Participant Flow|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
665605|NCT01171924|P1|Participant Flow|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
665606|NCT01171924|O2|Outcome|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
665607|NCT01171924|O1|Outcome|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
665608|NCT01171924|E2|Reported Event|Arm B: 3 Days/Week|
665609|NCT01171924|E1|Reported Event|Arm A: 5 Days/Week|
665610|NCT01171963|B3|Baseline|Total|Total of all reporting groups
665611|NCT01171963|B2|Baseline|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665612|NCT01171963|B1|Baseline|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665613|NCT01171963|P2|Participant Flow|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665614|NCT01171963|P1|Participant Flow|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665682|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665615|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665616|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665617|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665618|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665619|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665620|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665621|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665683|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665684|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665685|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665686|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665687|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665918|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665622|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665693|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665694|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665695|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665696|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665697|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665623|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665624|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665625|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665626|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665627|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665628|NCT01171963|O1|Outcome|Overall Study Arm|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665629|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665698|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665699|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665700|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665701|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665702|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
666922|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
665630|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665631|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665632|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665633|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665634|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665635|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665636|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665703|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665704|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665705|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665706|NCT01171976|E3|Reported Event|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665707|NCT01171976|E2|Reported Event|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665637|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665638|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665639|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665640|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665641|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665642|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665643|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665708|NCT01171976|E1|Reported Event|TE Ranibizumab 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665709|NCT01171989|B4|Baseline|Total|Total of all reporting groups
665710|NCT01171989|B3|Baseline|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665644|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665645|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665646|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665647|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665648|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665649|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665650|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665711|NCT01171989|B2|Baseline|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665829|NCT01172288|E2|Reported Event|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
665651|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665652|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665653|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665654|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665655|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665656|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665657|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665712|NCT01171989|B1|Baseline|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665830|NCT01172288|E1|Reported Event|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
665831|NCT01172353|B3|Baseline|Total|Total of all reporting groups
665658|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665659|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665660|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.Not Applicable
665661|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665662|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665663|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665664|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665713|NCT01171989|P3|Participant Flow|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665832|NCT01172353|B2|Baseline|Saline|"hydration with saline 1ml/Kg/h for 6 hours
saline: hydration with saline 1ml/Kg/h for 6 hours"
665665|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665666|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665667|NCT01171963|E2|Reported Event|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665668|NCT01171963|E1|Reported Event|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
665669|NCT01171976|B4|Baseline|Total|Total of all reporting groups
665670|NCT01171976|B3|Baseline|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665671|NCT01171976|B2|Baseline|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665672|NCT01171976|B1|Baseline|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665673|NCT01171976|P3|Participant Flow|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665674|NCT01171976|P2|Participant Flow|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665675|NCT01171976|P1|Participant Flow|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665676|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665677|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665678|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665679|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665680|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665681|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665688|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665689|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665690|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
665691|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
665692|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
665714|NCT01171989|P2|Participant Flow|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665715|NCT01171989|P1|Participant Flow|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665716|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665717|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665718|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665719|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665720|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665721|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665722|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665723|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665724|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665725|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665824|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
665919|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665726|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665727|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
666027|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665728|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665729|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665730|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665731|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665732|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665733|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665734|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665735|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665736|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665737|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665738|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665739|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665740|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665741|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665742|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665743|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665744|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665745|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665746|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665747|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665748|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665749|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665750|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665751|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665752|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665753|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665754|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665755|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
666685|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID
Ranolazine: ranolazine 1000 mg PO BID for 3 months"
665756|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665757|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665758|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665759|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665760|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665761|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665762|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665763|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665764|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665765|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665766|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665767|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665768|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665769|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665833|NCT01172353|B1|Baseline|Sodium Bicarbonate|"hydration with sodium bicarbonate
sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
665770|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665771|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665772|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665773|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665774|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665775|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665776|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665777|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665778|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665779|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665780|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665781|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665782|NCT01171989|E3|Reported Event|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665783|NCT01171989|E2|Reported Event|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665784|NCT01171989|E1|Reported Event|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
665785|NCT01172145|B3|Baseline|Total|Total of all reporting groups
665786|NCT01172145|B2|Baseline|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
665787|NCT01172145|B1|Baseline|Cholinesterase Inhibitor Only|participants who received placebo
665788|NCT01172145|P2|Participant Flow|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
665789|NCT01172145|P1|Participant Flow|Cholinesterase Inhibitor Only|participants who received placebo
665790|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
665791|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
665792|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
665793|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
665794|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
665795|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
665796|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
665797|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
665798|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
665799|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
665800|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
665801|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
665802|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
665803|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
665804|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
665805|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
665806|NCT01172145|E2|Reported Event|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
665807|NCT01172145|E1|Reported Event|Cholinesterase Inhibitor Only|participants who received placebo
665808|NCT01172184|B1|Baseline|Patients With Either Chronic or Acute Mitral Regurgitation|
665809|NCT01172184|P1|Participant Flow|Patients With Either Chronic or Acute Mitral Regurgitation|
665810|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
665811|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
665812|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
665813|NCT01172184|E1|Reported Event|Patients With Either Chronic or Acute Mitral Regurgitation|
665814|NCT01172288|B3|Baseline|Total|Total of all reporting groups
665815|NCT01172288|B2|Baseline|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
665816|NCT01172288|B1|Baseline|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
665817|NCT01172288|P2|Participant Flow|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
665818|NCT01172288|P1|Participant Flow|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
665819|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
665820|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
665821|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
665822|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
665823|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
666022|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665825|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
665826|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
665827|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
665828|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
665834|NCT01172353|P2|Participant Flow|Saline|"hydration with saline 1ml/Kg/h for 6 hours
saline: hydration with saline 1ml/Kg/h for 6 hours"
665835|NCT01172353|P1|Participant Flow|Sodium Bicarbonate|"hydration with sodium bicarbonate
sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
665836|NCT01172353|O2|Outcome|Saline|"hydration with saline 1ml/Kg/h for 6 hours
saline: hydration with saline 1ml/Kg/h for 6 hours"
665837|NCT01172353|O1|Outcome|Sodium Bicarbonate|"hydration with sodium bicarbonate
sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
665838|NCT01172353|O2|Outcome|Saline|"hydration with saline 1ml/Kg/h for 6 hours
saline: hydration with saline 1ml/Kg/h for 6 hours"
665839|NCT01172353|O1|Outcome|Sodium Bicarbonate|"hydration with sodium bicarbonate
sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
665840|NCT01172353|E2|Reported Event|Saline|"hydration with saline 1ml/Kg/h for 6 hours
saline: hydration with saline 1ml/Kg/h for 6 hours"
665841|NCT01172353|E1|Reported Event|Sodium Bicarbonate|"hydration with sodium bicarbonate
sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
665842|NCT01172418|B3|Baseline|Total|Total of all reporting groups
665843|NCT01172418|B2|Baseline|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
665844|NCT01172418|B1|Baseline|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction"
665845|NCT01172418|P2|Participant Flow|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
665846|NCT01172418|P1|Participant Flow|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction"
665847|NCT01172418|O2|Outcome|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
665848|NCT01172418|O1|Outcome|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction"
665849|NCT01172418|E2|Reported Event|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.
Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
665850|NCT01172418|E1|Reported Event|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)
Daclizumab: used in combination with Thymoglobulin as combined induction"
665851|NCT01172522|B3|Baseline|Total|Total of all reporting groups
665852|NCT01172522|B2|Baseline|Fexofenadine Left Side; Placebo Right Side|"Topical treatment active versus placebo.
Double blind randomized placebo controlled split face intrasubject comparison.
Fexofenadine, placebo"
665853|NCT01172522|B1|Baseline|Fexofenadine Right Side; Placebo Left Side|"Topical treatment active versus placebo.
Double blind randomized placebo controlled split face intrasubject comparison.
Placebo, fexofenadine"
665854|NCT01172522|P2|Participant Flow|Fexofenadine Left Side; Placebo Right Side|Subjects were randomized as to side of face treated with test article versus placebo
665855|NCT01172522|P1|Participant Flow|Fexofenadine Right Side; Placebo Left Side|"Topical treatment active versus placebo.
Double blind randomized placebo controlled split face intrasubject comparison. Participants were randomized to side of face with active drug versus side of face with control, but with each treatment going on concurrently."
665856|NCT01172522|O2|Outcome|Placebo|All participants that received placebo
665857|NCT01172522|O1|Outcome|Fexofenadine|All participants that received fexofenadine
665858|NCT01172522|E1|Reported Event|Split Face Intrasubject Comparison|"Topical treatment active versus placebo
Double blind randomized placebo controlled split face intrasubject comparison."
665859|NCT01172535|B1|Baseline|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavirr, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665916|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665860|NCT01172535|P1|Participant Flow|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665861|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665862|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665863|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665864|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665865|NCT01172535|O3|Outcome|Week 24|Participants bringing medication to be measured at study week 24
665866|NCT01172535|O2|Outcome|Week 12|Participants bringing medication to be measured at study week 12
665867|NCT01172535|O1|Outcome|Week 4|Participants bringing medication to be measured at study week 4
665868|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665869|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665870|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665871|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665872|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665873|NCT01172535|E1|Reported Event|LPV/r|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
665874|NCT01172600|B3|Baseline|Total|Total of all reporting groups
665875|NCT01172600|B2|Baseline|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665876|NCT01172600|B1|Baseline|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665877|NCT01172600|P2|Participant Flow|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665878|NCT01172600|P1|Participant Flow|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665879|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665880|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665881|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665882|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665883|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665884|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665885|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665886|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665917|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665887|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665888|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665889|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665890|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665891|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665892|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665893|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665894|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665895|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665896|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665897|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665898|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665899|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665900|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665901|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665902|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665903|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665904|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665905|NCT01172600|E2|Reported Event|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665906|NCT01172600|E1|Reported Event|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
665907|NCT01172808|B5|Baseline|Total|Total of all reporting groups
665908|NCT01172808|B4|Baseline|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665909|NCT01172808|B3|Baseline|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665910|NCT01172808|B2|Baseline|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665911|NCT01172808|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665912|NCT01172808|P4|Participant Flow|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665913|NCT01172808|P3|Participant Flow|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665914|NCT01172808|P2|Participant Flow|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665915|NCT01172808|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665920|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665921|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665922|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665923|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665924|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665925|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665926|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665927|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665928|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665929|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665930|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665931|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665932|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665933|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665934|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665935|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665936|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665937|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665938|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665939|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665940|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665941|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665942|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665943|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665944|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665945|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665946|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665947|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665948|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665949|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665950|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665951|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665952|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665953|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665954|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665955|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665956|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665957|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665958|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665959|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665960|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665961|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665962|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665963|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665964|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665965|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665966|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665967|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665968|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665969|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665970|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665971|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665972|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665973|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665974|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665975|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665976|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665977|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665978|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665979|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665980|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665981|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665982|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665983|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665984|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665985|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665986|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665987|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665988|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665989|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665990|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665991|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665992|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665993|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665994|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665995|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665996|NCT01172808|E4|Reported Event|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
665997|NCT01172808|E3|Reported Event|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
665998|NCT01172808|E2|Reported Event|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
665999|NCT01172808|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666000|NCT01172821|B5|Baseline|Total|Total of all reporting groups
666001|NCT01172821|B4|Baseline|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666002|NCT01172821|B3|Baseline|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666003|NCT01172821|B2|Baseline|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666004|NCT01172821|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666005|NCT01172821|P4|Participant Flow|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666006|NCT01172821|P3|Participant Flow|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666007|NCT01172821|P2|Participant Flow|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666008|NCT01172821|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666009|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666010|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666011|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666012|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666013|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666014|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666015|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666016|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666017|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666018|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666019|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666020|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666021|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666023|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666024|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666025|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666028|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666029|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666030|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666031|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666032|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666033|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666034|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666035|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666036|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666037|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666038|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666039|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666040|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666041|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666042|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666043|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666044|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666045|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666046|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666047|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666048|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666049|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666050|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666051|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666052|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666053|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666054|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666055|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666056|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666057|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666058|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666059|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666060|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666061|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666062|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666063|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666064|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666065|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666066|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666067|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666068|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666069|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666070|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666071|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666072|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666073|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666074|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666075|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666076|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666077|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666078|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666079|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666080|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666081|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666082|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666083|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666084|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666085|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666086|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666087|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666088|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666089|NCT01172821|E4|Reported Event|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666090|NCT01172821|E3|Reported Event|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
666091|NCT01172821|E2|Reported Event|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
666092|NCT01172821|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
666093|NCT01172847|B1|Baseline|Oseltamivir; Rimantadine; Oseltamivir + Rimantadine|Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.
666094|NCT01172847|P1|Participant Flow|Oseltamivir; Rimantadine; Oseltamivir + Rimantadine|Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.
666095|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
666096|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
666097|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
666098|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
666099|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
666100|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
666101|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
666102|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
666103|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
666104|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
666105|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
666106|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
666107|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
666108|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
666109|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
666110|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
666111|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
666112|NCT01172847|O1|Outcome|Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
666113|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
666114|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
666115|NCT01172847|E3|Reported Event|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
666116|NCT01172847|E2|Reported Event|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
666117|NCT01172847|E1|Reported Event|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
666118|NCT01172873|B3|Baseline|Total|Total of all reporting groups
666119|NCT01172873|B2|Baseline|E/RP Alone (no DCS Administration)|Five participants were enrolled in the second treatment arm as a comparison. The participants received 10 twice-weekly sessions of E/RP treatment alone.
666120|NCT01172873|B1|Baseline|D-cycloserine + E/RP|Participants in this treatment arm received 10 twice-weekly sessions of E/RP treatment and were administered D-Cycloserine (DCS) immediately after every treatment visit.
666155|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666121|NCT01172873|P2|Participant Flow|E/RP Alone (no DCS Administration)|The final 5 participants enrolled in the study were assigned to a second treatment arm, to compare E/RP alone to E/RP with D-Cycloserine. These participants received 10 twice-weekly sessions of E/RP without D-Cycloserine. DCS was not administered to this group during the active study period.
666122|NCT01172873|P1|Participant Flow|D-cycloserine + E/RP|The first 11 participants received 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
666123|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
666124|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
666125|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
666126|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
666127|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
666128|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
666129|NCT01172873|E2|Reported Event|E/RP Alone (no DCS Administration)|Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions.
666130|NCT01172873|E1|Reported Event|D-cycloserine + E/RP|Participants in this arm receive 10 twice-weekly 60-minute sessions of Exposure and Response Prevention (E/RP) therapy and 50mg of D-Cycloserine immediately after each therapy session. D-Cycloserine is only administered on days in which therapy sessions are held.
666131|NCT01172938|B4|Baseline|Total|Total of all reporting groups
666132|NCT01172938|B3|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666133|NCT01172938|B2|Baseline|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666134|NCT01172938|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666135|NCT01172938|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
666136|NCT01172938|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
666137|NCT01172938|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years.
666138|NCT01172938|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
666139|NCT01172938|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 28-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
666140|NCT01172938|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 28-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
666141|NCT01172938|P1|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
666142|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666143|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666144|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666145|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666146|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666147|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666148|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666149|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666150|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666151|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666152|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666153|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666154|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666918|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
666156|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666157|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666158|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666159|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666160|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666161|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666162|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666163|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666164|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666165|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666166|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666167|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666168|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666169|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666170|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666171|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666172|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666173|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666174|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666175|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666176|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666177|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666178|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666179|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666180|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666181|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666182|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666183|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666184|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666185|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666186|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666187|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666188|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666189|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666190|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666191|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666192|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666193|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666194|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666195|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666196|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666197|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666198|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666199|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666200|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666201|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666202|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666203|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666204|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666205|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666206|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666207|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666208|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
666209|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
666210|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666211|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666212|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666213|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666214|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666215|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666216|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666217|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666218|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666219|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666220|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666221|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666222|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666223|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666224|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666225|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666226|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666227|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666228|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666229|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666230|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666231|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666232|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666233|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666234|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666235|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666236|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666237|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666238|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666239|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666240|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666241|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666242|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666243|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666244|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666245|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666246|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666247|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666248|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666249|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666250|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666251|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666252|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666253|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666254|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666255|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666256|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666257|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666258|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666259|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666260|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666261|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666262|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666263|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666264|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666265|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666266|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666267|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666268|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666269|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666270|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666271|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666272|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666273|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666274|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666275|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666276|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666277|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666278|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666279|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666280|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666281|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666282|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
667013|NCT01174784|E1|Reported Event|Enrolled/Primary Cohort|
666283|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666284|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666285|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666686|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID
Ranolazine: ranolazine 1000 mg PO BID for 3 months"
666286|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666287|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666288|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666289|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666290|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666291|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666292|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666293|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666294|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666295|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666296|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666297|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666298|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666299|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666300|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666301|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666302|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666303|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666304|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666305|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
666306|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666307|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666308|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666309|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
666310|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
666311|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
666312|NCT01172938|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
666313|NCT01172938|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
666314|NCT01172938|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
666315|NCT01172938|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
666316|NCT01172938|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
666317|NCT01173029|B3|Baseline|Total|Total of all reporting groups
666318|NCT01173029|B2|Baseline|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
666319|NCT01173029|B1|Baseline|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
666320|NCT01173029|P2|Participant Flow|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
666321|NCT01173029|P1|Participant Flow|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
667014|NCT01175005|B1|Baseline|Fever and a Central Venous Catheter|
666322|NCT01173029|O9|Outcome|Polygenic Score: Eight|Sum of the weights for analyzing polymorphisms equal to eight.
666323|NCT01173029|O8|Outcome|Polygenic Score: Seven|Sum of the weights for analyzing polymorphisms equal to seven.
666324|NCT01173029|O7|Outcome|Polygenic Score: Six|Sum of the weights for analyzing polymorphisms equal to six.
666325|NCT01173029|O6|Outcome|Polygenic Score: Five|Sum of the weights for analyzing polymorphisms equal to five.
666326|NCT01173029|O5|Outcome|Polygenic Score: Four|Sum of the weights for analyzing polymorphisms equal to four.
666327|NCT01173029|O4|Outcome|Polygenic Score: Three|Sum of the weights for analyzing polymorphisms equal to three.
666328|NCT01173029|O3|Outcome|Polygenic Score: Two|Sum of the weights for analyzing polymorphisms equal to two.
666329|NCT01173029|O2|Outcome|Polygenic Score: One|Sum of the weights for analyzing polymorphisms equal to one.
666330|NCT01173029|O1|Outcome|Polygenic Score: Zero|Sum of the weights for analyzing polymorphisms equal to zero.
666331|NCT01173029|O2|Outcome|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
666332|NCT01173029|O1|Outcome|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
666333|NCT01173029|O2|Outcome|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
666334|NCT01173029|O1|Outcome|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
666335|NCT01173029|E2|Reported Event|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
666336|NCT01173029|E1|Reported Event|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
666337|NCT01173055|B3|Baseline|Total|Total of all reporting groups
666338|NCT01173055|B2|Baseline|Placebo First, Then Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666339|NCT01173055|B1|Baseline|Milnacipran First, Then Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666340|NCT01173055|P2|Participant Flow|Placebo First, Then Milnacipran|"Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo First, Then Milnacipran: Period 1 (Day 1-49); Placebo matching study treatment was administered beginning Period 1 (Day 1-49) and a 14 day washout period. Then, Milnacipran Period 2 (Day 64-112); Milnacipran 12.5mg Day 62; 12.5mg twice daily (BID) Day 65 to 66; 25mg BID Day 67 to 70; 50mg BID Day 71-77; 100mg BID Day 78-105 followed by taper Day 106-112."
666341|NCT01173055|P1|Participant Flow|Milnacipran First, Then Placebo|"Milnacipran then placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Milnacipran First, Then Placebo: Period 1 (Day 1-49); Milnacipran 12.5mg by mouth (PO) Day 1; 12.5mg twice daily (BID) Day 2 to 3; 25mg BID Day 4 to 7; 50mg BID Day 8-14; 100mg BID Day 15-42 followed by taper Day 43-49 and a 14 day washout period. Then, placebo matching study treatment in similar pattern to Period 1 was administered beginning Period 2 (Day 64-112)."
666342|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666343|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666344|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666345|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666687|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID
Ranolazine: ranolazine 1000 mg PO BID for 3 months"
666346|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666347|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666348|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666349|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666350|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666351|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666352|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666353|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
666354|NCT01173055|E2|Reported Event|Placebo|Placebo was given orally twice daily in tablet form at different times during the course of the study.
666355|NCT01173055|E1|Reported Event|Milnacipran|Milnacipran was given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
666356|NCT01173120|B1|Baseline|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666357|NCT01173120|P1|Participant Flow|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666358|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666359|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666360|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666361|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666362|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666688|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID
Ranolazine: ranolazine 1000 mg PO BID for 3 months"
666363|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666364|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666365|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666366|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666367|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666368|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous abatacept via the ACP for the duration of the substudy. Abatacept was administered subcutaneously using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a pre-filled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666369|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666370|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666371|NCT01173120|E1|Reported Event|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
666372|NCT01173211|B7|Baseline|Total|Total of all reporting groups
666373|NCT01173211|B6|Baseline|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666374|NCT01173211|B5|Baseline|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666375|NCT01173211|B4|Baseline|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666376|NCT01173211|B3|Baseline|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666377|NCT01173211|B2|Baseline|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666378|NCT01173211|B1|Baseline|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666379|NCT01173211|P6|Participant Flow|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666380|NCT01173211|P5|Participant Flow|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666381|NCT01173211|P4|Participant Flow|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666382|NCT01173211|P3|Participant Flow|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666383|NCT01173211|P2|Participant Flow|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666384|NCT01173211|P1|Participant Flow|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666689|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID
Ranolazine: ranolazine 1000 mg PO BID for 3 months"
666385|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666386|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666387|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666388|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666389|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666390|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666391|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666392|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666393|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666394|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666395|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666396|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666397|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666398|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666399|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666400|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666401|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666402|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666403|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666404|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666405|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666406|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666407|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666408|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666409|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666410|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666411|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666676|NCT01174160|B1|Baseline|Vernakalant IV|"vernakalant hydrochloride
Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
666412|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666413|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666414|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666415|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666416|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666417|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666418|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666419|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666420|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666421|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666422|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666423|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666424|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666425|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666426|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666427|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666428|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666429|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666430|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666431|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666432|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666433|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666434|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666435|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666436|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666437|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666438|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666439|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666440|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666441|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666677|NCT01174160|P2|Participant Flow|Placebo|"placebo
Up to two 10-min infusions of normal saline"
666442|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666443|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666444|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666690|NCT01174173|E1|Reported Event|Ranolazine|Ranolazine: ranolazine 1000 mg PO BID for 3 months
666691|NCT01174186|B3|Baseline|Total|Total of all reporting groups
666445|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666446|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666447|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666448|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666449|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666450|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666451|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666452|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666453|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666454|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666455|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666456|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666457|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666458|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666459|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666460|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666461|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666462|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666463|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666464|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666465|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666466|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666467|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666468|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666469|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666470|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666678|NCT01174160|P1|Participant Flow|Vernakalant IV|"vernakalant hydrochloride
Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
666471|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666472|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666473|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666474|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666924|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
666475|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666476|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666477|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666478|NCT01173211|E6|Reported Event|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666479|NCT01173211|E5|Reported Event|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666480|NCT01173211|E4|Reported Event|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666481|NCT01173211|E3|Reported Event|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
666482|NCT01173211|E2|Reported Event|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
666483|NCT01173211|E1|Reported Event|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
666484|NCT01167426|B1|Baseline|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
666485|NCT01167426|P1|Participant Flow|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
666486|NCT01167426|O1|Outcome|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
666487|NCT01167426|O1|Outcome|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
666488|NCT01167426|E2|Reported Event|Period 2: Glatirimer Actetate|Participants received once daily subcutaneous administration of glatiramer acetate 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
666489|NCT01167426|E1|Reported Event|Period 1: Glatiramer Acetate 20 mg/1.0 mL|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1).
666490|NCT01167452|B1|Baseline|Sulfamethoxazole/Trimethoprim|All volunteers received a single dose oral dose of TMP/SMX (1600 mg/320 mg).
666491|NCT01167452|P1|Participant Flow|Sulfamethoxazole/Trimethoprim|"2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg)
Sulfamethoxazole/trimethoprim: 2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose"
666492|NCT01167452|O2|Outcome|Trimethoprim|Results from trimethoprim analysis
666493|NCT01167452|O1|Outcome|Sulfamethoxazole|Results from sulfamethoxazole analysis
666494|NCT01167452|E1|Reported Event|Sulfamethoxazole/Trimethoprim|All volunteers received a single dose of TMP/SMX (1600 mg/320 mg).
666495|NCT01167504|B1|Baseline|Saliva Sample Collection|Collection of whole mouth and parotid saliva
666496|NCT01167504|P1|Participant Flow|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
666497|NCT01167504|O1|Outcome|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
666498|NCT01167504|O1|Outcome|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
666499|NCT01167504|E1|Reported Event|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
666500|NCT01167582|B3|Baseline|Total|Total of all reporting groups
666501|NCT01167582|B2|Baseline|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
666502|NCT01167582|B1|Baseline|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
666532|NCT01167634|P1|Participant Flow|1 - Control|"Control - no financial incentive or match
Participants are given the goal of losing 1 pound per week for 24 weeks are asked to weigh-in monthly with no financial incentive."
666679|NCT01174160|O2|Outcome|Placebo|"placebo
Up to two 10-min infusions of normal saline"
666680|NCT01174160|O1|Outcome|Vernakalant IV|"vernakalant hydrochloride
Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
666503|NCT01167582|P2|Participant Flow|Restrictive Transfusion Strategy|"Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL.
Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension."
666504|NCT01167582|P1|Participant Flow|Liberal Transfusion Strategy|Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL.
666505|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL
666506|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
666507|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL
666508|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
666509|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
666510|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
666511|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
666512|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
666513|NCT01167582|E2|Reported Event|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
666514|NCT01167582|E1|Reported Event|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
666515|NCT01167608|B1|Baseline|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
666516|NCT01167608|P1|Participant Flow|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
666517|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
666518|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
666519|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
666520|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
666521|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
666522|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
666523|NCT01167608|E1|Reported Event|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
666524|NCT01167634|B5|Baseline|Total|Total of all reporting groups
666525|NCT01167634|B4|Baseline|Experimental 4 - Deposit With no Match|"Deposit contract with no match
Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666526|NCT01167634|B3|Baseline|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match
Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666527|NCT01167634|B2|Baseline|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match
Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666528|NCT01167634|B1|Baseline|1 - Control|
666529|NCT01167634|P4|Participant Flow|Experimental 4 - Deposit With no Match|"Deposit contract with no match
Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666530|NCT01167634|P3|Participant Flow|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match
Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666531|NCT01167634|P2|Participant Flow|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match
Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666681|NCT01174160|E2|Reported Event|Placebo|"placebo
Up to two 10-min infusions of normal saline"
666533|NCT01167634|O4|Outcome|Experimental 4 - Deposit With no Match|"Deposit contract with no match
Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666534|NCT01167634|O3|Outcome|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match
Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666535|NCT01167634|O2|Outcome|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match
Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666536|NCT01167634|O1|Outcome|1 - Control|Usual care arm
666692|NCT01174186|B2|Baseline|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin
Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
666537|NCT01167634|E4|Reported Event|Experimental 4 - Deposit Contract With no Match|"Deposit contract with no match
Deposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666538|NCT01167634|E3|Reported Event|3 - Deposit Contract With a 2:1 Match|"Deposit contract with a 2:1 match
Deposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666539|NCT01167634|E2|Reported Event|2 - Deposit Contract With a 1:1 Match|"Deposit contract with a 1:1 match
Deposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made."
666540|NCT01167634|E1|Reported Event|1 - Control|"Control - no financial incentive or match
Participants are given the goal of losing 1 pound per week for 24 weeks are asked to weigh-in monthly with no financial incentive."
666541|NCT01167829|B1|Baseline|Acyline and Oral Testosterone|300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
666542|NCT01167829|P1|Participant Flow|Acyline and 0ral Testosterone|Acyline 300 mcg/kg subcutaneous + 300mg modified slow-release oral testosterone tid
666543|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
666544|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
666545|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
666546|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
666547|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
666548|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
666549|NCT01167829|O1|Outcome|Acyline and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
666550|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
666551|NCT01167829|O1|Outcome|Acyine and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
666552|NCT01167829|O1|Outcome|Acyline and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
666553|NCT01167829|E1|Reported Event|Acyline and Oral Testosterone|300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
666554|NCT01173471|B5|Baseline|Total|Total of all reporting groups
666555|NCT01173471|B4|Baseline|AZD4017 400 mg BID|AZD4017 400 mg twice daily
666556|NCT01173471|B3|Baseline|Placebo BID|Placebo twice daily
666557|NCT01173471|B2|Baseline|AZD4017 200 mg OD|AZD4017 200 mg once daily
666558|NCT01173471|B1|Baseline|Placebo OD|Placebo once daily
666559|NCT01173471|P4|Participant Flow|AZD4017 400 mg BID|AZD4017 400 mg twice daily
666560|NCT01173471|P3|Participant Flow|Placebo BID|Placebo twice daily
666561|NCT01173471|P2|Participant Flow|AZD4017 200 mg OD|AZD4017 200 mg once daily
666562|NCT01173471|P1|Participant Flow|Placebo OD|Placebo once daily
666563|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
666564|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
666565|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
666566|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
666567|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
666568|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
666569|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
666570|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
666571|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
666572|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
666573|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
666574|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
666575|NCT01173471|E4|Reported Event|AZD4017 400 mg BID|AZD4017 400 mg twice daily
666576|NCT01173471|E3|Reported Event|Placebo BID|Placebo twice daily
666577|NCT01173471|E2|Reported Event|AZD4017 200 mg OD|AZD4017 200 mg once daily
666578|NCT01173471|E1|Reported Event|Placebo OD|Placebo once daily
666579|NCT01173523|B3|Baseline|Total|Total of all reporting groups
666580|NCT01173523|B2|Baseline|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
666581|NCT01173523|B1|Baseline|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
666582|NCT01173523|P2|Participant Flow|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
666583|NCT01173523|P1|Participant Flow|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
666584|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
666585|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
666586|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
666587|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
666588|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
666589|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
666590|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
666591|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
666592|NCT01173523|E2|Reported Event|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
666593|NCT01173523|E1|Reported Event|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
666594|NCT01173718|B1|Baseline|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
666595|NCT01173718|P1|Participant Flow|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
666596|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
666597|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
666598|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
666599|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
666600|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
666601|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
666602|NCT01173718|E1|Reported Event|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft
666603|NCT01173848|B3|Baseline|Total|Total of all reporting groups
666604|NCT01173848|B2|Baseline|Vitamin D3|"Patient's randomized to take Vitamin D3
Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
666605|NCT01173848|B1|Baseline|Vitamin D2|"Patients randomized to take vitamin D2
Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
666912|NCT01174446|O5|Outcome|Study Completion or Termination Visit|
666606|NCT01173848|P2|Participant Flow|Vitamin D3|"Patient's randomized to take Vitamin D3
Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
666607|NCT01173848|P1|Participant Flow|Vitamin D2|"Patients randomized to take vitamin D2
Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
666608|NCT01173848|O2|Outcome|Vitamin D3|"Patient's randomized to take Vitamin D3
Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
666609|NCT01173848|O1|Outcome|Vitamin D2|"Patients randomized to take vitamin D2
Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
666693|NCT01174186|B1|Baseline|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin
Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
666610|NCT01173848|E1|Reported Event|Vitamin D2 and Vitamin D3|"Adverse Events were not logged by study arms.
Patients randomized to take vitamin D2
Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months
or
Patient's randomized to take Vitamin D3
Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
666611|NCT01173874|B3|Baseline|Total|Total of all reporting groups
666612|NCT01173874|B2|Baseline|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
666613|NCT01173874|B1|Baseline|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.
Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
666614|NCT01173874|P2|Participant Flow|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
666615|NCT01173874|P1|Participant Flow|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.
Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
666616|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
666617|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.
Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
666618|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
666619|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.
Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
666620|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
666621|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.
Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
666622|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
666623|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.
Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
666624|NCT01173874|E2|Reported Event|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
666925|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
666625|NCT01173874|E1|Reported Event|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.
Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
666626|NCT01174004|B3|Baseline|Total|Total of all reporting groups
666627|NCT01174004|B2|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
666628|NCT01174004|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
666629|NCT01174004|P2|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
666630|NCT01174004|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
666631|NCT01174004|O2|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
666632|NCT01174004|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
666633|NCT01174004|O2|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
666634|NCT01174004|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
666635|NCT01174004|E2|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
666636|NCT01174004|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
666637|NCT01174030|B6|Baseline|Total|Total of all reporting groups
666638|NCT01174030|B5|Baseline|Vehicle Gel BID|
666639|NCT01174030|B4|Baseline|Vehicle Gel QD|
666640|NCT01174030|B3|Baseline|CD07805/47 Gel 0.18% BID|
666641|NCT01174030|B2|Baseline|CD07805/47 Gel 0.18% QD|
666642|NCT01174030|B1|Baseline|CD07805/47 Gel 0.5% QD|
666643|NCT01174030|P5|Participant Flow|Vehicle Gel BID|Vehicle Gel Twice Daily
666644|NCT01174030|P4|Participant Flow|Vehicle Gel QD|Vehicle Gel Once Daily
666645|NCT01174030|P3|Participant Flow|CD07805/47 Gel 0.18% BID|CD07805/47 Gel 0.18% Twice Daily
666646|NCT01174030|P2|Participant Flow|CD07805/47 Gel 0.18% QD|CD07805/47 Gel 0.18% Once Daily
666647|NCT01174030|P1|Participant Flow|CD07805/47 Gel 0.5% QD|CD07805/47 Gel 0.5% Once Daily
666648|NCT01174030|O5|Outcome|Vehicle Gel BID|
666649|NCT01174030|O4|Outcome|Vehicle Gel QD|
666650|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
666651|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
666652|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
666653|NCT01174030|O5|Outcome|Vehicle Gel BID|
666654|NCT01174030|O4|Outcome|Vehicle Gel QD|
666655|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
666656|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
666657|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
666658|NCT01174030|O5|Outcome|Vehicle Gel BID|
666659|NCT01174030|O4|Outcome|Vehicle Gel QD|
666660|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
666661|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
666662|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
666663|NCT01174030|E5|Reported Event|Vehicle Gel BID|
666664|NCT01174030|E4|Reported Event|Vehicle Gel QD|
666665|NCT01174030|E3|Reported Event|CD07805/47 Gel 0.18% BID|
666666|NCT01174030|E2|Reported Event|CD07805/47 Gel 0.18% QD|
666667|NCT01174030|E1|Reported Event|CD07805/47 Gel 0.5% QD|
666668|NCT01174043|B1|Baseline|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
666669|NCT01174043|P1|Participant Flow|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
666670|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
666671|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
666672|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
666673|NCT01174043|E1|Reported Event|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
666674|NCT01174160|B3|Baseline|Total|Total of all reporting groups
666675|NCT01174160|B2|Baseline|Placebo|"placebo
Up to two 10-min infusions of normal saline"
666682|NCT01174160|E1|Reported Event|Vernakalant IV|"vernakalant hydrochloride
Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
666683|NCT01174173|B1|Baseline|Ranolazine|"1000 mg PO BID
Ranolazine: ranolazine 1000 mg PO BID for 3 months"
666684|NCT01174173|P1|Participant Flow|Ranolazine|"1000 mg PO BID
Ranolazine: ranolazine 1000 mg PO BID for 3 months"
666694|NCT01174186|P2|Participant Flow|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin
Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
666695|NCT01174186|P1|Participant Flow|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin
Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
666696|NCT01174186|O2|Outcome|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin
Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
666697|NCT01174186|O1|Outcome|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin
Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
666698|NCT01174186|O1|Outcome|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin
Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
666699|NCT01174186|E2|Reported Event|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin
Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
666700|NCT01174186|E1|Reported Event|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin
Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
666701|NCT01174264|B4|Baseline|Total|Total of all reporting groups
666702|NCT01174264|B3|Baseline|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose of vismodegib PO after eating a low fat meal. Beginning 7 days later, patients receive vismodegib PO after eating a meal daily on days 1-28.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666703|NCT01174264|B2|Baseline|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose of vismodegib PO after eating a high fat meal. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666704|NCT01174264|B1|Baseline|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose of vismodegib PO on an empty stomach. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666705|NCT01174264|P3|Participant Flow|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666706|NCT01174264|P2|Participant Flow|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666707|NCT01174264|P1|Participant Flow|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666708|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666709|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666710|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666711|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666712|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666713|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666714|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666715|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666716|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666717|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666718|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666719|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666720|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
667017|NCT01175005|O1|Outcome|Blood Culture Positive|Procalcitonin level in patients with fever and a CVC with positive blood culture
666721|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666722|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666723|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666724|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666725|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666726|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666727|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666728|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666729|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666730|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666731|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666732|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666733|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666734|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666735|NCT01174264|E3|Reported Event|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666736|NCT01174264|E2|Reported Event|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666737|NCT01174264|E1|Reported Event|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.
Pharmacological Study: Correlative studies
Vismodegib: Given PO"
666738|NCT01174342|B1|Baseline|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
666739|NCT01174342|P1|Participant Flow|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
666740|NCT01174342|O1|Outcome|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery
666741|NCT01174342|E1|Reported Event|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
666742|NCT01174446|B1|Baseline|All Study Participants Who Received Study Drug|"BAX326 : -Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX
Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only
Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1"
666743|NCT01174446|P4|Participant Flow|Study Part 2 Only: BAX326 On-Demand|-Participants were only in Study Part 2 (i.e., did not participate in Study Parts 1 and 3)
666744|NCT01174446|P3|Participant Flow|Study Part 2 Only: BAX326 Prophylaxis|-Participants were only in Study Part 2 (i.e., did not participate in Study Parts 1 and 3)
666745|NCT01174446|P2|Participant Flow|PK (BeneFIX Then BAX326) Then Prophylaxis Then PK BAX326 Only|"Study Part 1: Pharmacokinetic (PK) Crossover with BeneFIX (75 ± 5 IU/kg) then BAX326 (75 ± 5 IU/kg).
Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only
Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 (75 ± 5 IU/kg) only and same study participants as Study Part 1"
666746|NCT01174446|P1|Participant Flow|PK (BAX326 Then BeneFIX) Then Prophylaxis Then PK BAX326 Only|"Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 (75 ± 5 IU/kg) then BeneFIX (75 ± 5 IU/kg).
Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only
Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 (75 ± 5 IU/kg) only and same study participants as Study Part 1"
666913|NCT01174446|O4|Outcome|Part 2 or Part 3: Week 26|
666794|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day (ED) 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666795|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666796|NCT01174446|O5|Outcome|On-Demand: End of Study|
666923|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg
Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
666747|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666748|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666749|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666750|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666751|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666752|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666753|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666754|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666755|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666756|NCT01174446|O3|Outcome|Change From Baseline|
666757|NCT01174446|O2|Outcome|End of Study|
666758|NCT01174446|O1|Outcome|Part 1 or Part 2, Exposure Day 1 (Baseline)|
666759|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666760|NCT01174446|O5|Outcome|On-Demand: End of Study|
666761|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666762|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666763|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666764|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666765|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666766|NCT01174446|O5|Outcome|On-Demand: End of Study|
666824|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666825|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666826|NCT01174446|O5|Outcome|On-Demand: End of Study|
666854|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666767|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666768|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666769|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666770|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666771|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666772|NCT01174446|O5|Outcome|On-Demand: End of Study|
666773|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666774|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666775|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666776|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666777|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666778|NCT01174446|O5|Outcome|On-Demand: End of Study|
666779|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666780|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666781|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666782|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666783|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666784|NCT01174446|O5|Outcome|On-Demand: End of Study|
666785|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666786|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666787|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666788|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666789|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666790|NCT01174446|O5|Outcome|On-Demand: End of Study|
666914|NCT01174446|O3|Outcome|Part 2: Week 13|"PK infusion with BAX326 at 75 ± 5 IU/kg
Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
666915|NCT01174446|O2|Outcome|Part 2: Week 5|PK infusion with BeneFIX at 75 ± 5 IU/kg
666916|NCT01174446|O1|Outcome|Part 1 or Part 2, ED 1|PK infusion with BAX326 at 75 ± 5 IU/kg
666917|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg
Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
666791|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day (ED) 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666792|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666793|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666797|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666798|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666799|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666800|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666801|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666802|NCT01174446|O5|Outcome|On-Demand: End of Study|
666803|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666804|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666805|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666806|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666807|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666808|NCT01174446|O5|Outcome|On-Demand: End of Study|
666809|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666810|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666811|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666812|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666813|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666814|NCT01174446|O5|Outcome|On-Demand: End of Study|
666815|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666816|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666817|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666818|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666819|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666820|NCT01174446|O5|Outcome|On-Demand: End of Study|
666821|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666822|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666823|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666827|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666828|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666829|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666830|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666831|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666832|NCT01174446|O5|Outcome|On-Demand: End of Study|
666833|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666834|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666835|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666836|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666837|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666838|NCT01174446|O5|Outcome|On-Demand: End of Study|
666839|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666840|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666841|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666842|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666843|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666844|NCT01174446|O5|Outcome|On-Demand: End of Study|
666845|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666846|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666847|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666848|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666849|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
666850|NCT01174446|O5|Outcome|On-Demand: End of Study|
666851|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666852|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666853|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666857|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):
Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved
Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves
Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:
Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}
Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:
Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg
Amount administered & frequency should be oriented to individual clinical effectiveness"
666858|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
666859|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
666860|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
666861|NCT01174446|O2|Outcome|Participants With AEs - Related|"Probable, possible, or unknown causality assessment of an AE will be counted as related."
666862|NCT01174446|O1|Outcome|Participants With AEs - Not Related|
666863|NCT01174446|O2|Outcome|AEs - Related|"Probable, possible, or unknown causality assessment of an AE will be counted as related."
666864|NCT01174446|O1|Outcome|AEs - Not Related|
666865|NCT01174446|O1|Outcome|All Study Participants|
666866|NCT01174446|O1|Outcome|All Study Participants|
666867|NCT01174446|O1|Outcome|All Study Participants|
666868|NCT01174446|O1|Outcome|All Study Participants|
666869|NCT01174446|O1|Outcome|All Study Participants|
666870|NCT01174446|O1|Outcome|All Study Participants|
666871|NCT01174446|O1|Outcome|All Study Participants|
666872|NCT01174446|O1|Outcome|All Study Participants|
666873|NCT01174446|O1|Outcome|All Study Participants|
666874|NCT01174446|O2|Outcome|On-Demand|Study Part 2 Only
666875|NCT01174446|O1|Outcome|Prophylaxis|Study Part 2 Only
666876|NCT01174446|O2|Outcome|On-Demand|Study Part 2 Only
666877|NCT01174446|O1|Outcome|Prophylaxis|Study Part 2 Only
666878|NCT01174446|O2|Outcome|Bleeding Treatment|Includes all participants who received any infusions for bleeding treatment in the Full Analysis Set. (ie includes all On-demand arm (N=14) and 33 participants from the prophylaxis arm who experienced a bleeding episode)
666879|NCT01174446|O1|Outcome|Prophylactic Treatment|
666880|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
666881|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
666882|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
666883|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
666884|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
666885|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
666886|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
666887|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
666888|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
666889|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
666890|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
666891|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
666892|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
666893|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
666894|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
666895|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
666896|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
666897|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
666898|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
666899|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
666900|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
666901|NCT01174446|O1|Outcome|BAX326 Prophylaxis|"Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
Participants received a minimum of three months prophylactic treatment"
666902|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg
Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
666903|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
666904|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
666905|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg
Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
666906|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
666907|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
666908|NCT01174446|O4|Outcome|Study Completion or Termination Visit|
666909|NCT01174446|O3|Outcome|Part 2 or Part 3: Week 26|
666910|NCT01174446|O2|Outcome|Part 2: Week 13|
666911|NCT01174446|O1|Outcome|Part 2: Week 5|PK infusion with BAX326 at 75 ± 5 IU/kg
666919|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
666920|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg
Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
666926|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg
Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
666927|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
666928|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
666929|NCT01174446|O2|Outcome|BeneFIX|
666930|NCT01174446|O1|Outcome|BAX326|
666931|NCT01174446|E1|Reported Event|BAX326|"BAX326: -Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX
Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only
Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1"
666932|NCT01174459|B1|Baseline|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
666933|NCT01174459|P1|Participant Flow|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
666934|NCT01174459|O1|Outcome|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
666935|NCT01174459|O1|Outcome|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
666936|NCT01174459|E1|Reported Event|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
666937|NCT01174550|B3|Baseline|Total|Total of all reporting groups
666938|NCT01174550|B2|Baseline|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666939|NCT01174550|B1|Baseline|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666940|NCT01174550|P2|Participant Flow|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666941|NCT01174550|P1|Participant Flow|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666942|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666943|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666944|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666945|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666946|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666947|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666948|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666949|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666950|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666951|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666952|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666953|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666954|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666955|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666956|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666957|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
667015|NCT01175005|P1|Participant Flow|Fever and a Central Venous Catheter|
667016|NCT01175005|O2|Outcome|Blood Culture Negative|Procalcitonin level in patients with fever and a CVC with negative blood culture
666958|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666959|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666960|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666961|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666962|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666963|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666964|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666965|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666966|NCT01174550|E2|Reported Event|Anatomic Diagnostic Test|"Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing"
666967|NCT01174550|E1|Reported Event|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
666968|NCT01174576|B1|Baseline|Group 1|
666969|NCT01174576|P1|Participant Flow|Caffeinated Coffee/Decaffeinated Coffee/Water|"200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight or instant decaffeinated coffee or water. All participants received all interventions without exception in a random order.
Three combinations of treatment sequences were used:
Caffeinated coffee, then decaffeinated coffee, then water
Decaffeinated coffee first, then water, then caffeinated coffee
Water first, then caffeinated coffee, then decaffeinated coffee.
Each treatment was separated by the other by at least one week interval.
The first volunteer entered the study received the first combination, the second volunteer the second combiation, the third volunteer the third combination, the forth volunteer the first combination of treatments, etc."
666970|NCT01174576|O3|Outcome|Water|200 mL
666971|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
666972|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
666973|NCT01174576|O3|Outcome|Water|200 mL
666974|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
666975|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
666976|NCT01174576|O3|Outcome|Water|200 mL
666977|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
666978|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
666979|NCT01174576|O3|Outcome|Water|200 ml water
666980|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 ml instant decaffeinated coffee
666981|NCT01174576|O1|Outcome|Caffeinated Coffee|200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight
666982|NCT01174576|O3|Outcome|Water|200 mL
666983|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
666984|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/ kg body weight
666985|NCT01174576|O3|Outcome|Water|200 ml water
666986|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 ml instant decaffeinated coffee
666987|NCT01174576|O1|Outcome|Caffeinated Coffee|200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight
666988|NCT01174576|O3|Outcome|Water|200 mL
666989|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
666990|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
666991|NCT01174576|O3|Outcome|Water|200 mL
666992|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeineated coffee
666993|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
666994|NCT01174576|O3|Outcome|Water|200 mL
666995|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
666996|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
666997|NCT01174576|O3|Outcome|Water|200 mL
666998|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
666999|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
667000|NCT01174576|O3|Outcome|Water|200 mL
667001|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
667002|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
667003|NCT01174576|O3|Outcome|Water|200 mL
667004|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
667005|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
667006|NCT01174576|E3|Reported Event|Water|200 mL
667007|NCT01174576|E2|Reported Event|Decaffeinated Coffee|200 mL decaffeinated coffee, same amount as caffeinated coffee
667008|NCT01174576|E1|Reported Event|Caffeinated Coffee|200 mL, coffee containing 3 mg caffeine/kg body weight
667009|NCT01174784|B1|Baseline|Enrolled/Primary Cohort|
667010|NCT01174784|P1|Participant Flow|Enrolled/Primary Cohort|
667011|NCT01174784|O1|Outcome|Enrolled/Primary Cohort|
667012|NCT01174784|O1|Outcome|Enrolled/Primary Cohort|
667021|NCT01175018|B1|Baseline|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667022|NCT01175018|P2|Participant Flow|Placebo|0.67 ml of sodium chloride (NaCl) 0.9% solution
667023|NCT01175018|P1|Participant Flow|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667024|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667025|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667026|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667027|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667028|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667029|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667030|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667031|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667032|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667033|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667034|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667035|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667036|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667037|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667038|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667039|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667040|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667041|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667042|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667043|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667044|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667045|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667046|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667047|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667048|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667049|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667050|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667051|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667052|NCT01175018|O2|Outcome|Placebo|"0.67 ml of NaCl 0.9% solution
Placebo: 0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days"
667053|NCT01175018|O1|Outcome|Anakinra|"Anakinra 100 mg injectable subcutaneously daily
Anakinra: Anakinra 100 mg s.c. daily for 14 days"
667054|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
667055|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667056|NCT01175018|E2|Reported Event|Placebo|0.67 ml of NaCl 0.9% solution
667057|NCT01175018|E1|Reported Event|Anakinra|Anakinra 100 mg injectable subcutaneously daily
667058|NCT01175031|B1|Baseline|Sleep Apnea|Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved.
667059|NCT01175031|P1|Participant Flow|Sleep Apnea|Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved.
667060|NCT01175031|O1|Outcome|Device-Detected Clear Airway Apneas|Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
667061|NCT01175031|O1|Outcome|Device-Detected Obstructive Airway Apneas|Of the device-detected obstructive airway apneas a comparison was done of manually scored verses device detected.
667062|NCT01175031|O1|Outcome|Device-Detected Apneas|Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
667063|NCT01175031|O2|Outcome|Manually Scored Polysomnography (PSG)|"Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG).
Manipulation of Positive Airway Pressure (PAP): Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. It will be measure by the REMstar Auto with A-Flex and manually scored PSG."
667064|NCT01175031|O1|Outcome|REMstar Auto With A-Flex|"Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG).
Manipulation of Positive Airway Pressure (PAP): Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. It will be measure by the REMstar Auto with A-Flex and manually scored PSG."
667065|NCT01175031|E1|Reported Event|Subjects With Sleep Apnea|Subjects aged 21 thru 80 with a diagnosis of CompSAS or OSA and able to undergo a full-night in the sleep laboratory.
667066|NCT01175148|B3|Baseline|Total|Total of all reporting groups
667067|NCT01175148|B2|Baseline|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
667068|NCT01175148|B1|Baseline|Recipient Arm|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.
Atorvastatin calcium (Lipitor): 40 mg PO daily"
667069|NCT01175148|P2|Participant Flow|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
667070|NCT01175148|P1|Participant Flow|Recipient Arm|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.
Atorvastatin calcium (Lipitor): 40 mg PO daily"
667071|NCT01175148|O1|Outcome|Recipient Arm - Experimental|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.
Atorvastatin calcium (Lipitor): 40 mg PO daily"
667072|NCT01175148|E2|Reported Event|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
667073|NCT01175148|E1|Reported Event|Recipient Arm - Experimental|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.
Atorvastatin calcium (Lipitor): 40 mg PO daily"
667074|NCT01175213|B5|Baseline|Total|Total of all reporting groups
667075|NCT01175213|B4|Baseline|Participants Aged 65 Years and Older|
667076|NCT01175213|B3|Baseline|Participants Aged 16 to <65 Years|
667077|NCT01175213|B2|Baseline|Participants Aged 12 to <16 Years|
667078|NCT01175213|B1|Baseline|Participants Aged 2 to <12 Years|
667079|NCT01175213|P2|Participant Flow|IGIV, 10% Only|"Participants were treated with Immune Globulin Intravenous (Human) (IGIV), 10% only, via the intravenous (IV) route throughout the study.
Note: IGIV, 10% is the same product as IGSC, 10%."
667080|NCT01175213|P1|Participant Flow|IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only|"Efficacy and safety of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20). Participants then went into a safety follow-up with either SC administration of IGSC, 10% or intravenous (IV) administration of Immune Globulin Intravenous (Human) (IGIV), 10%, only. The IV or SC administration route was at the discretion of the participant and the investigator.
Note: IGIV, 10% is the same product as IGSC, 10%."
667081|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667082|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667083|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667084|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667085|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667086|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667087|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667088|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667089|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667090|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667091|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667092|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667093|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667094|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667095|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667096|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667097|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667098|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667099|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667100|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667101|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667102|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667103|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667104|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667152|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
667315|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667105|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667106|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667107|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667108|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667109|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
667110|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
667111|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
667112|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
667113|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667114|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667115|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667116|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667117|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667118|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667119|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20 and/or IGSC, 10%|"All participants who had been exposed to either or both study drugs in the Safety Analysis Data Set. Study drugs are Immune Globulin Subcutaneous Solution, 10%, (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20).
This includes the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20. The 3 participants were treated at 4-week intervals only.
Number of participants in each treatment interval [N] is provided."
667120|NCT01175213|O1|Outcome|All Participants Treated With IGSC, 10% and rHuPH20|"Participants treated with at least one dose of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
This does not include the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20."
667121|NCT01175213|O1|Outcome|All Participants Treated With IGSC, 10% and rHuPH20|"Participants treated with at least one dose of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
This does not include the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20."
667153|NCT01175343|E1|Reported Event|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
667154|NCT01175369|B3|Baseline|Total|Total of all reporting groups
667122|NCT01175213|E2|Reported Event|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).
At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.
Note: IGIV, 10% is the same product as IGSC, 10%."
667123|NCT01175213|E1|Reported Event|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
667124|NCT01175226|B3|Baseline|Total|Total of all reporting groups
667125|NCT01175226|B2|Baseline|Placebo|Placebo: Placebo twice daily
667126|NCT01175226|B1|Baseline|BTA798|BTA798: BTA798 twice daily
667127|NCT01175226|P2|Participant Flow|Placebo|Placebo: Placebo twice daily
667128|NCT01175226|P1|Participant Flow|BTA798|BTA798: BTA798 twice daily
667129|NCT01175226|O2|Outcome|Placebo|Placebo: Placebo twice daily
667130|NCT01175226|O1|Outcome|BTA798|BTA798: BTA798 twice daily
667131|NCT01175226|E2|Reported Event|Placebo|Placebo: Placebo twice daily
667132|NCT01175226|E1|Reported Event|BTA798|BTA798: BTA798 twice daily
667133|NCT01175317|B3|Baseline|Total|Total of all reporting groups
667134|NCT01175317|B2|Baseline|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
667135|NCT01175317|B1|Baseline|Goald-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
667136|NCT01175317|P2|Participant Flow|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
667137|NCT01175317|P1|Participant Flow|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
667138|NCT01175317|O2|Outcome|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
667139|NCT01175317|O1|Outcome|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
667140|NCT01175317|O2|Outcome|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
667141|NCT01175317|O1|Outcome|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
667142|NCT01175317|E2|Reported Event|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
667143|NCT01175317|E1|Reported Event|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
667144|NCT01175343|B1|Baseline|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
667145|NCT01175343|P1|Participant Flow|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
667146|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
667147|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
667148|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
667149|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
667150|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
667151|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.
Gamma-Secretase Inhibitor RO4929097: Given PO
Laboratory Biomarker Analysis: Correlative studies"
667155|NCT01175369|B2|Baseline|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
667157|NCT01175369|P2|Participant Flow|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
667158|NCT01175369|P1|Participant Flow|Usual Care|Usual asthma care
667159|NCT01175369|O2|Outcome|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
667160|NCT01175369|O1|Outcome|Usual Care|Usual asthma care
667161|NCT01175369|E2|Reported Event|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
667162|NCT01175369|E1|Reported Event|Usual Care|Usual asthma care
667163|NCT01175382|B4|Baseline|Total|Total of all reporting groups
667164|NCT01175382|B3|Baseline|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667165|NCT01175382|B2|Baseline|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667166|NCT01175382|B1|Baseline|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
667167|NCT01175382|P3|Participant Flow|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667168|NCT01175382|P2|Participant Flow|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667169|NCT01175382|P1|Participant Flow|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
667170|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667171|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667172|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667173|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
668430|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
667174|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667175|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667176|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667177|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667178|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667179|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667180|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667181|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667182|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667183|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667184|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667185|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667186|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667187|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667188|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667189|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667190|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667191|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667192|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667193|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667194|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667195|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667196|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667197|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667198|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667199|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667200|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667310|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667201|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667202|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667203|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667204|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667205|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667206|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667207|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667208|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667209|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667210|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667211|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667212|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667213|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667214|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667215|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667216|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667217|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667218|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667219|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667220|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667221|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667222|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667223|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667224|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667225|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667226|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667227|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667311|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667228|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667229|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667230|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667231|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667232|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667233|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667234|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667235|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667236|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667237|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667238|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667239|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667240|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
667241|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
667242|NCT01175382|E3|Reported Event|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667243|NCT01175382|E2|Reported Event|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
667244|NCT01175382|E1|Reported Event|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
667245|NCT01175395|B1|Baseline|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
667246|NCT01175395|P1|Participant Flow|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
667247|NCT01175395|O1|Outcome|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
667248|NCT01175395|O1|Outcome|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
667249|NCT01175395|E1|Reported Event|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
667250|NCT01175434|B3|Baseline|Total|Total of all reporting groups
667251|NCT01175434|B2|Baseline|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
667252|NCT01175434|B1|Baseline|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
667253|NCT01175434|P2|Participant Flow|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
667254|NCT01175434|P1|Participant Flow|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
667255|NCT01175434|O2|Outcome|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
667256|NCT01175434|O1|Outcome|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
667257|NCT01175434|E2|Reported Event|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
667312|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667313|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667314|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667258|NCT01175434|E1|Reported Event|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
667259|NCT01175473|B3|Baseline|Total|Total of all reporting groups
667260|NCT01175473|B2|Baseline|Liraglutide|2-step initiation regimen of liraglutide: 0.6 mg QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
667261|NCT01175473|B1|Baseline|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4.
667262|NCT01175473|P2|Participant Flow|Liraglutide|2-step initiation regimen of liraglutide: 0.6 milligram (mg) QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
667263|NCT01175473|P1|Participant Flow|Lixisenatide|1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4.
667264|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
667265|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
667266|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
667267|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
667268|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
667269|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
667270|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
667271|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
667272|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
667273|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
667274|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
667275|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
667276|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
667277|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
667278|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
667279|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
667280|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
667281|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
667282|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
667283|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
667284|NCT01175473|E2|Reported Event|Liraglutide|2-step initiation regimen of liraglutide.
667285|NCT01175473|E1|Reported Event|Lixisenatide|1-step initiation regimen of lixisenatide.
667286|NCT01175590|B3|Baseline|Total|Total of all reporting groups
667287|NCT01175590|B2|Baseline|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667288|NCT01175590|B1|Baseline|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667289|NCT01175590|P2|Participant Flow|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667290|NCT01175590|P1|Participant Flow|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667291|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667292|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667293|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667294|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667295|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667296|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667297|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667298|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667299|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667300|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667301|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667302|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667303|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667304|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667305|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667306|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667307|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667308|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667309|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667316|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667317|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667318|NCT01175590|O1|Outcome|Besivance|besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days
667319|NCT01175590|E2|Reported Event|Vehicle|"Vehicle of Besivance
Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
667320|NCT01175590|E1|Reported Event|Besivance|"besifloxacin ophthalmic suspension 0.6%
Besivance : Ocular administration to affected eye for 7 days"
667321|NCT01175668|B3|Baseline|Total|Total of all reporting groups
667322|NCT01175668|B2|Baseline|NMS/Phenobarbital|
667323|NCT01175668|B1|Baseline|NMS/Clonidine|
667324|NCT01175668|P2|Participant Flow|NMS/Phenobarbital|"Dosing was based on the Finnegan scores as below
Finn Score 8-10 NMS 0.32mg/kg/day +Phenobarbital 6 mg/kg/day 11-13 NMS 0.48 mg/kg/day +Phenobarbital 8 mg/kg/day 14-16 NMS 0.64 mg/kg/day +Phenobarbital 10 mg/kg/day ≥17 NMS 0.8 mg/kg/day* + Phenobarbital 12 mg/kg/day
Daily NMS dose was divided for q3h dosing interval Daily Phenobarbital dose was divided for q8h dosing interval
*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8"
667325|NCT01175668|P1|Participant Flow|NMS/Clonidine|"Dosing was based on the Finnegan scores as below
Finn Score 8-10 NMS 0.32mg/kg/day + Clonidine 6 mcg/kg/day 11-13 NMS 0.48 mg/kg/day + Clonidine 8 mcg/kg/day 14-16 NMS 0.64 mg/kg/day + Clonidine 10 mcg/kg/day ≥17 NMS 0.8 mg/kg/day* + Clonidine 12 mcg/kg/day
Daily NMS dose was divided for q3h dosing interval Daily Clonidine dose was divided for q6h dosing interval Clonidine escalation may be limited by hypotension or bradycardia
*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8"
667326|NCT01175668|O2|Outcome|NMS/Phenobarbital|
667327|NCT01175668|O1|Outcome|NMS/Clonidine|
667328|NCT01175668|O2|Outcome|NMS/Phenobarbital|
667329|NCT01175668|O1|Outcome|NMS/Clonidine|
667330|NCT01175668|E2|Reported Event|NMS/Phenobarbital|
667331|NCT01175668|E1|Reported Event|NMS/Clonidine|
667332|NCT01175707|B3|Baseline|Total|Total of all reporting groups
667333|NCT01175707|B2|Baseline|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667334|NCT01175707|B1|Baseline|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667335|NCT01175707|P2|Participant Flow|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667336|NCT01175707|P1|Participant Flow|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667337|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667338|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667339|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667340|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667341|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667342|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667343|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667344|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667345|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667346|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667347|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667348|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667349|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667350|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667351|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667352|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667353|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667354|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667355|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667356|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted
667357|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667358|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667359|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667360|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667361|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667362|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667363|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667364|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667365|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667366|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667367|NCT01175707|E2|Reported Event|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
667368|NCT01175707|E1|Reported Event|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
667369|NCT01175798|B3|Baseline|Total|Total of all reporting groups
667370|NCT01175798|B2|Baseline|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
667371|NCT01175798|B1|Baseline|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
667372|NCT01175798|P2|Participant Flow|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
667373|NCT01175798|P1|Participant Flow|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
668013|NCT01177293|B1|Baseline|Entire Study Population|Includes groups randomized to receive any treatment first (amlodipine capsule first and amlodipine ODT first).
667374|NCT01175798|O2|Outcome|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
667375|NCT01175798|O1|Outcome|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
667376|NCT01175798|E2|Reported Event|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
667377|NCT01175798|E1|Reported Event|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
667378|NCT01175811|B3|Baseline|Total|Total of all reporting groups
667379|NCT01175811|B2|Baseline|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667380|NCT01175811|B1|Baseline|Premixed Insulin|"Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667381|NCT01175811|P2|Participant Flow|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro
Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667382|NCT01175811|P1|Participant Flow|Premixed Insulin|"Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667383|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667384|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667385|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667386|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667387|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667388|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667389|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667390|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667391|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667392|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667393|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667394|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667395|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667396|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667397|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667398|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667399|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667400|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667401|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667402|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667403|NCT01175811|E2|Reported Event|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro
Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
667404|NCT01175811|E1|Reported Event|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
667405|NCT01175824|B3|Baseline|Total|Total of all reporting groups
667406|NCT01175824|B2|Baseline|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667407|NCT01175824|B1|Baseline|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667408|NCT01175824|P2|Participant Flow|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667409|NCT01175824|P1|Participant Flow|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667410|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667411|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667412|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667413|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667414|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667415|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667416|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667417|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667418|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667419|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667420|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667421|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667422|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667423|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667424|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667425|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667426|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667427|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667428|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
668773|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
667429|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667430|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667431|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667432|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667433|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667434|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667435|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667436|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667437|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667438|NCT01175824|E2|Reported Event|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
667439|NCT01175824|E1|Reported Event|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
667440|NCT01175850|B3|Baseline|Total|Total of all reporting groups
667441|NCT01175850|B2|Baseline|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667442|NCT01175850|B1|Baseline|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667443|NCT01175850|P2|Participant Flow|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
667444|NCT01175850|P1|Participant Flow|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
667445|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667446|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667447|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667448|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667449|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667450|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667451|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667452|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667453|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667454|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667455|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667456|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667457|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667458|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667459|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667460|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667461|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667462|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667463|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667464|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667465|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667466|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667467|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667468|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667469|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667470|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667471|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667472|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667473|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667474|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667475|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667476|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667477|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
667478|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667479|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
667480|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667481|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667482|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
667483|NCT01175850|E2|Reported Event|Standard PTA|"Standard Percutaneous Transluminal Angioplasty (PTA) Balloon: Balloon Angioplasty
PTA Balloon: Balloon Angioplasty: balloon dilatation and provisional stenting with standard non-coated PTA balloon"
667484|NCT01175850|E1|Reported Event|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty
Drug-Coated Balloon (DCB): balloon dilatation and provisional stenting with IN.PACT DCB"
667485|NCT01175902|B3|Baseline|Total|Total of all reporting groups
667486|NCT01175902|B2|Baseline|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667487|NCT01175902|B1|Baseline|Latanoprost|"Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667488|NCT01175902|P2|Participant Flow|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667489|NCT01175902|P1|Participant Flow|Latanoprost|"Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667490|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667491|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667492|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667493|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667494|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667495|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667496|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667497|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667498|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667499|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667500|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667501|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667502|NCT01175902|E2|Reported Event|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667503|NCT01175902|E1|Reported Event|Latanoprost|"Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day"
667504|NCT01176032|B3|Baseline|Total|Total of all reporting groups
667505|NCT01176032|B2|Baseline|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667506|NCT01176032|B1|Baseline|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667507|NCT01176032|P2|Participant Flow|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667508|NCT01176032|P1|Participant Flow|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667509|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667510|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667511|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667512|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667513|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667514|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667515|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667516|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667517|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667518|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667519|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667520|NCT01176032|O3|Outcome|Losartan|losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667521|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667522|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667523|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667524|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
668774|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
667525|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667526|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667527|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667528|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667529|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667530|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667531|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667532|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667533|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667534|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667535|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667536|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667537|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667538|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667539|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667540|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667541|NCT01176032|O2|Outcome|Aliskiren + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667542|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667543|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667544|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667545|NCT01176032|O2|Outcome|Aliskiren + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
667546|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667547|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667548|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667549|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667550|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667551|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667552|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667553|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667554|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667555|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667556|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667557|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667558|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667559|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667560|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667561|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667562|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667563|NCT01176032|E2|Reported Event|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
667564|NCT01176032|E1|Reported Event|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
667565|NCT01176058|B3|Baseline|Total|Total of all reporting groups
667959|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
667566|NCT01176058|B2|Baseline|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667567|NCT01176058|B1|Baseline|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667568|NCT01176058|P2|Participant Flow|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant’s tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667569|NCT01176058|P1|Participant Flow|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667570|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667571|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667572|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667573|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667574|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667575|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667576|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667577|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667578|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667579|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667580|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667581|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667582|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667583|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667584|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667585|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667586|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667587|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667588|NCT01176058|E2|Reported Event|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667589|NCT01176058|E1|Reported Event|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
667590|NCT01176240|B5|Baseline|Total|Total of all reporting groups
667591|NCT01176240|B4|Baseline|Study 306B: Placebo|"Placebo matched control
Placebo: Placebo"
667592|NCT01176240|B3|Baseline|Study 306B: Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667593|NCT01176240|B2|Baseline|Study 306A: Placebo|"Placebo matched control
Placebo: Placebo"
667594|NCT01176240|B1|Baseline|Study 306A: Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667595|NCT01176240|P2|Participant Flow|Placebo|"Placebo matched control
Placebo: Placebo"
667596|NCT01176240|P1|Participant Flow|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667597|NCT01176240|O2|Outcome|Placebo|"Placebo matched control
Placebo: Placebo"
667598|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667599|NCT01176240|O2|Outcome|Placebo|"Placebo matched control
Placebo: Placebo"
667600|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667601|NCT01176240|O2|Outcome|Placebo|"Placebo matched control
Placebo: Placebo"
667602|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667603|NCT01176240|O2|Outcome|Placebo|"Placebo matched control
Placebo: Placebo"
667604|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667605|NCT01176240|O2|Outcome|Placebo|"Placebo matched control
Placebo: Placebo"
667606|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667607|NCT01176240|O2|Outcome|Placebo|"Placebo matched control
Placebo: Placebo"
667608|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667609|NCT01176240|O2|Outcome|Placebo|"Placebo matched control
Placebo: Placebo"
667610|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667611|NCT01176240|O2|Outcome|Placebo|"Placebo matched control
Placebo: Placebo"
667612|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667613|NCT01176240|O2|Outcome|Placebo|"Placebo matched control
Placebo: Placebo"
667614|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667615|NCT01176240|O2|Outcome|Placebo|"Placebo matched control
Placebo: Placebo"
667616|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
667617|NCT01176240|E2|Reported Event|Placebo|"Placebo matched control
Placebo: Placebo
Placebo Safety set excludes 3 patients randomized to placebo who were mistakenly dosed with droxidopa for short periods of time during the trial."
667618|NCT01176240|E1|Reported Event|Droxidopa|"droxidopa active drug
Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment
Droxidopa Safety set includes 3 patients randomized to placebo who were mistakenly dosed with droxidopa for short periods of time during the trial."
667619|NCT01176292|B3|Baseline|Total|Total of all reporting groups
667620|NCT01176292|B2|Baseline|Rotating Platform Cruciate Substituting TKA|
667621|NCT01176292|B1|Baseline|Rotating Platform High-Flex Cruciate Substituting TKA|
667622|NCT01176292|P2|Participant Flow|Rotating Platform Cruciate Substituting TKA|
667623|NCT01176292|P1|Participant Flow|Rotating Platform High-Flex Cruciate Substituting TKA|
667624|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
667625|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
667626|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
667627|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
667628|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
667629|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
667630|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
667631|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
667632|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
667633|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
667634|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
667635|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
667636|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
667637|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
667638|NCT01176292|E2|Reported Event|Rotating Platform Cruciate Substituting TKA|
667639|NCT01176292|E1|Reported Event|Rotating Platform High-Flex Cruciate Substituting TKA|
667640|NCT01176448|B1|Baseline|Patients With Scars|12 individual scars on 6 patients were treated. Each scar was divided in half, and the halves randomized to either fractionated laser resurfacing or dermabrasion.
667641|NCT01176448|P1|Participant Flow|Patients With Scars|"12 long scars were recruited for individual study. Only 6 patients were needed as each patient had two separate scars to be studied. Each scar was divided in half, and the halves randomized to fractionated laser resurfacing or dermabrasion.
The half of the scar randomized to fractionated CO2 laser was treated first. The Re:Pair CO2 laser was used, with a fluence of 40 mJ and a treatment level of 8 (Solta Medical Inc., Hayward, CA). Four passes of the laser were used in total, with two in the orthogonal direction. A standard diamond fraise dermabrader was used on the area painted with gentian violet down through the dermal–epidermal junction. Dermabrasion was performed until a uniform area of punctate bleeding was obtained, and the edges were feathered into the surrounding epidermis."
667642|NCT01176448|O2|Outcome|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared. 6 patients had 12 scars treated (2 scars per patient.
667643|NCT01176448|O1|Outcome|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser. 6 patients had 12 scars treated (2 scars per patient.
667644|NCT01176448|O2|Outcome|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
667645|NCT01176448|O1|Outcome|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser
667646|NCT01176448|E2|Reported Event|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
667647|NCT01176448|E1|Reported Event|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser
667648|NCT01176513|B1|Baseline|GE 148-002|GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
667649|NCT01176513|P1|Participant Flow|GE 148-002|GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
667650|NCT01176513|O1|Outcome|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
667651|NCT01176513|O1|Outcome|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
667652|NCT01176513|E1|Reported Event|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
667653|NCT01179191|B1|Baseline|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667654|NCT01179191|P1|Participant Flow|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667655|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667656|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667657|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667658|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667659|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667660|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667661|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667662|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667663|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667664|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667665|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667666|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667667|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667668|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667669|NCT01179191|E1|Reported Event|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
667670|NCT01179217|B3|Baseline|Total|Total of all reporting groups
667671|NCT01179217|B2|Baseline|Placebo|"Patients will be randomized to receive Placebo.
Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667672|NCT01179217|B1|Baseline|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667673|NCT01179217|P2|Participant Flow|Placebo|"Patients will be randomized to receive Placebo.
Placebo (100% maltodextrin): 0.3 g/kg of placebo will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667674|NCT01179217|P1|Participant Flow|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667675|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.
Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667676|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667677|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.
Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667678|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667703|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
668011|NCT01177228|E2|Reported Event|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
667679|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.
Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667680|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667681|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.
Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667682|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667683|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.
Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667684|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667685|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.
Placebo: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667686|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667687|NCT01179217|O2|Outcome|Placebo|"Patients will be randomized to receive Placebo.
Placebo (100% maltodextrin): 0.3 g/kg of placebo will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667688|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667704|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667958|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
667689|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.
100% maltodextrin: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667690|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667691|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.
100% maltodextrin: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667692|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667693|NCT01179217|O2|Outcome|100% Maltodextrin|"Patients will be randomized to receive Placebo.
100% maltodextrin: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667694|NCT01179217|O1|Outcome|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667695|NCT01179217|E2|Reported Event|100% Maltodextrin|"Patients will be randomized to receive Placebo.
100% maltodextrin: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration."
667696|NCT01179217|E1|Reported Event|L-glutamine|"Patients will be randomized to receive investigational product, L-Glutamine.
L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended."
667697|NCT01179334|B3|Baseline|Total|Total of all reporting groups
667698|NCT01179334|B2|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667699|NCT01179334|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667700|NCT01179334|P2|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667701|NCT01179334|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667702|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
668012|NCT01177228|E1|Reported Event|Placebo|Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.
667705|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667706|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667707|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667708|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667709|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667710|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667711|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667712|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667713|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667714|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667715|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667716|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667717|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667718|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667719|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667720|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667721|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667722|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667723|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667724|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667725|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667726|NCT01179334|E2|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667847|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
667727|NCT01179334|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
667728|NCT01179347|B3|Baseline|Total|Total of all reporting groups
667729|NCT01179347|B2|Baseline|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667730|NCT01179347|B1|Baseline|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667731|NCT01179347|P2|Participant Flow|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667732|NCT01179347|P1|Participant Flow|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667733|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667734|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667735|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667736|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667737|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667738|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667739|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667740|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667741|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667742|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667743|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667744|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667745|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667746|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
667747|NCT01179347|E4|Reported Event|Tio 5mcg Randomized Group Over the Study|
667748|NCT01179347|E3|Reported Event|Placebo Randomized Group Over the Open−Label Period|
667749|NCT01179347|E2|Reported Event|Tio 5mcg Randomized Group Over the Double−Blind Period|
667750|NCT01179347|E1|Reported Event|Placebo Randomized Group Over the Double−Blind Period|
667751|NCT01179399|B1|Baseline|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
667752|NCT01179399|P1|Participant Flow|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
667753|NCT01179399|O1|Outcome|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
667754|NCT01179399|E1|Reported Event|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
667755|NCT01179490|B1|Baseline|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667756|NCT01179490|P1|Participant Flow|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667757|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667758|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667759|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667760|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667761|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667762|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667763|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667764|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667765|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667766|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667767|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667768|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667769|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667770|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667771|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667772|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667848|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667773|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667774|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667775|NCT01179490|E1|Reported Event|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
667776|NCT01179516|B4|Baseline|Total|Total of all reporting groups
667777|NCT01179516|B3|Baseline|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
667778|NCT01179516|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
667779|NCT01179516|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
667780|NCT01179516|P3|Participant Flow|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
667781|NCT01179516|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
667782|NCT01179516|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
667783|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
667784|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
667785|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
667786|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
667787|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
667788|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
667789|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
667790|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
667791|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
667792|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
667793|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
667794|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
667795|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
667796|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
667797|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
667798|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
667799|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
667800|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
667801|NCT01179516|E3|Reported Event|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
667802|NCT01179516|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
667803|NCT01179516|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
667804|NCT01179568|B5|Baseline|Total|Total of all reporting groups
667805|NCT01179568|B4|Baseline|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
667849|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
667850|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667806|NCT01179568|B3|Baseline|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667807|NCT01179568|B2|Baseline|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.
Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
667808|NCT01179568|B1|Baseline|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667809|NCT01179568|P4|Participant Flow|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
667810|NCT01179568|P3|Participant Flow|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667811|NCT01179568|P2|Participant Flow|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.
Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
667812|NCT01179568|P1|Participant Flow|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667813|NCT01179568|O3|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
667814|NCT01179568|O2|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667815|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667816|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.
Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
667817|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667818|NCT01179568|O3|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
667819|NCT01179568|O2|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667820|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667821|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.
Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
667822|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667851|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
667852|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667823|NCT01179568|O4|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
667824|NCT01179568|O3|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667825|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.
Placebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
667826|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667827|NCT01179568|E4|Reported Event|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
667828|NCT01179568|E3|Reported Event|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.
Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667829|NCT01179568|E2|Reported Event|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.
Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
667830|NCT01179568|E1|Reported Event|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.
Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
667831|NCT01179672|B3|Baseline|Total|Total of all reporting groups
667832|NCT01179672|B2|Baseline|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667833|NCT01179672|B1|Baseline|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1 then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
667834|NCT01179672|P2|Participant Flow|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667835|NCT01179672|P1|Participant Flow|Duloxetine|30 milligrams (mg) duloxetine capsule administered orally, once daily (QD) during Week 1 then 60 mg duloxetine capsule orally, QD for the remaining 11 weeks of treatment. After a total 12 weeks of treatment or early discontinuation participants tapered off study drug (30 mg duloxetine capsule QD) for 1 week during taper.
667836|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667837|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
667838|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667839|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
667840|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667841|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
667842|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667843|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
667844|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667845|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper
667846|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667953|NCT01177098|P1|Participant Flow|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
667853|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
667854|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
667855|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
667856|NCT01179672|E4|Reported Event|Placebo Taper|After 12 weeks of treatment or early discontinuation, placebo administered orally, QD for 1 week during taper.
667857|NCT01179672|E3|Reported Event|Duloxetine Taper|After 12 weeks of treatment or early discontinuation, 30 mg duloxetine capsule administered orally, QD for 1 week during taper.
667858|NCT01179672|E2|Reported Event|Placebo Treatment|Placebo administered orally, QD for 12 weeks of the treatment.
667859|NCT01179672|E1|Reported Event|Duloxetine Treatment|30 mg duloxetine capsule administered orally, QD during Week 1 of the treatment; 60 mg capsule administered orally, QD for remaining 11 weeks of the treatment;
667860|NCT01173653|B3|Baseline|Total|Total of all reporting groups
667861|NCT01173653|B2|Baseline|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
667862|NCT01173653|B1|Baseline|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
667863|NCT01173653|P2|Participant Flow|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
667864|NCT01173653|P1|Participant Flow|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
667865|NCT01173653|O2|Outcome|Intervention Arm|Enrollees put in contact with 1-800-QUIT-NOW line
667866|NCT01173653|O1|Outcome|Control Arm|No intervention given to this ED population of smokers
667867|NCT01173653|E2|Reported Event|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
667868|NCT01173653|E1|Reported Event|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
667869|NCT01173679|B1|Baseline|Dasatinib, Rituximab, Fludarabine|"Single-arm
dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle
Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).
fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
667870|NCT01173679|P1|Participant Flow|Dasatinib, Rituximab, Fludarabine|"Single-arm
dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle
Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).
fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
667871|NCT01173679|O1|Outcome|Dasatinib, Rituximab, Fludarabine|"Single-arm
dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle
Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).
fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
667872|NCT01173679|O1|Outcome|Dasatinib, Rituximab, Fludarabine|"Single-arm
dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle
Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).
fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
667873|NCT01173679|O1|Outcome|Dasatinib, Rituximab, Fludarabine|"Single-arm, open-label
dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle
Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).
fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
667874|NCT01173679|E1|Reported Event|Dasatinib, Rituximab, Fludarabine|"Single-arm
dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle
Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).
fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
667875|NCT01176773|B1|Baseline|Juvéderm® Ultra Lip Injectable Gel|
667876|NCT01176773|P1|Participant Flow|Juvéderm® Ultra Lip Injectable Gel|
667877|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
667878|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
667879|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
667880|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
667881|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
667882|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|The Investigator determined the appropriate volume to inject based on clinical experience and the subject's cosmetic goals for lip enhancement.
667883|NCT01176773|E1|Reported Event|Juvéderm® Ultra Lip Injectable Gel|
667884|NCT01176877|B1|Baseline|Keloid Scar|Those with a diagnosis of keloid scar.
667885|NCT01176877|P1|Participant Flow|Keloid Scar|Subjects over the age of 18 with a clinical diagnosis of keloid scarring were included in the study. First, subjects completed a written questionnaire to collect demographic data, including personal history of keloid scarring, past and present use of keloid scar treatments, and internet access and use to find information related to keloid scars. Second, subjects completed a written questionnaire to assess knowledge about keloids. Next, subjects listened to a scripted, 5 minute educational lecture about keloid scars and then completed a written questionnaire to assess knowledge about keloids. Finally, subjects were contacted by phone 3 months later to complete a questionnaire to assess knowledge about keloids and to answer questions about keloid-related behaviors over the previous 3 months.
667954|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
667886|NCT01176877|O1|Outcome|Keloid Scars|Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. 3 months after the educational lecture, subjects completed an identical verbal questionnaire to assess knowledge about keloid scars.
667887|NCT01176877|O1|Outcome|Keloid Scar|Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. Immediately after the educational lecture, the subjects completed an identical written questionnaire to assess knowledge about keloid scars.
667888|NCT01176877|E1|Reported Event|Keloid Scar|
667889|NCT01176955|B3|Baseline|Total|Total of all reporting groups
667890|NCT01176955|B2|Baseline|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
667891|NCT01176955|B1|Baseline|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
667892|NCT01176955|P2|Participant Flow|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
667893|NCT01176955|P1|Participant Flow|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
667894|NCT01176955|O2|Outcome|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
667895|NCT01176955|O1|Outcome|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
667896|NCT01176955|O2|Outcome|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
667897|NCT01176955|O1|Outcome|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
667898|NCT01176955|O2|Outcome|Control|Patients received standard-of-care therapy without weekly Internet surveys.
667899|NCT01176955|O1|Outcome|Internet Survey|Patients received a weekly Internet survey to report on the status of their acne.
667900|NCT01176955|E2|Reported Event|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
667901|NCT01176955|E1|Reported Event|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
667902|NCT01176968|B3|Baseline|Total|Total of all reporting groups
667903|NCT01176968|B2|Baseline|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667904|NCT01176968|B1|Baseline|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667905|NCT01176968|P2|Participant Flow|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667906|NCT01176968|P1|Participant Flow|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667907|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667908|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667909|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667910|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667911|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667912|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667913|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667914|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667915|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667916|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667917|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667918|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667919|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667955|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
667920|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667921|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667922|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667923|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667924|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667925|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667926|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667927|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667928|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667929|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667930|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667931|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667932|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667933|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667934|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667935|NCT01176968|E2|Reported Event|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
667936|NCT01176968|E1|Reported Event|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
667937|NCT01177007|B1|Baseline|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
667938|NCT01177007|P1|Participant Flow|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
667939|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
667940|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
667956|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
667957|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
667941|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
667942|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
667943|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
667944|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
667945|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each treated lob
667946|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
667947|NCT01177007|O1|Outcome|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each tre
667948|NCT01177007|E1|Reported Event|TheraSphere|TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time
667949|NCT01177098|B3|Baseline|Total|Total of all reporting groups
667950|NCT01177098|B2|Baseline|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
667951|NCT01177098|B1|Baseline|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
667952|NCT01177098|P2|Participant Flow|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
667960|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
667961|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
667962|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
667963|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
667964|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
667965|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
667966|NCT01177098|E2|Reported Event|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
667967|NCT01177098|E1|Reported Event|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
667968|NCT01177228|B5|Baseline|Total|Total of all reporting groups
667969|NCT01177228|B4|Baseline|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
667970|NCT01177228|B3|Baseline|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85.
667971|NCT01177228|B2|Baseline|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
667972|NCT01177228|B1|Baseline|Placebo|Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.
667973|NCT01177228|P4|Participant Flow|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.
667974|NCT01177228|P3|Participant Flow|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
667975|NCT01177228|P2|Participant Flow|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg, IV infusion on Days 1, 15, 29 and 85.
667976|NCT01177228|P1|Participant Flow|Placebo|Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.
667977|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
667978|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
667979|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
667980|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
667981|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
667982|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
667983|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
667984|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
667985|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
667986|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
667987|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
667988|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
667989|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
667990|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
667991|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
667992|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
667993|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
667994|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
667995|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
667996|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
667997|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
667998|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
667999|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
668000|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
668001|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
668002|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
668003|NCT01177228|O2|Outcome|Vedolizumab (6 mg/kg)|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
668004|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
668005|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
668006|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
668007|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
668008|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.
668009|NCT01177228|E4|Reported Event|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
668010|NCT01177228|E3|Reported Event|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
668014|NCT01177293|P2|Participant Flow|Amlodipine ODT Then Amlodipine Capsule|Single oral dose amlodipine besylate 10 mg ODT in first intervention period and single oral dose of amlodipine besylate 10 mg capsule in second intervention period. A washout period of 14 days was maintained between each period.
668015|NCT01177293|P1|Participant Flow|Amlodipine Capsule Then Amlodipine ODT|Single oral dose amlodipine besylate 10 mg capsule in first intervention period and single oral dose of amlodipine besylate 10 mg oral disintegrating tablet (ODT) in second intervention period. A washout period of 14 days was maintained between each period.
668016|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
668017|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
668018|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
668019|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
668020|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
668021|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
668022|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
668023|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
668024|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
668025|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
668026|NCT01177293|E2|Reported Event|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
668027|NCT01177293|E1|Reported Event|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
668028|NCT01177384|B3|Baseline|Total|Total of all reporting groups
668029|NCT01177384|B2|Baseline|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
668030|NCT01177384|B1|Baseline|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
668031|NCT01177384|P2|Participant Flow|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
668032|NCT01177384|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
668033|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
668034|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
668035|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
668036|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
668037|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
668038|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
668039|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
668040|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
668041|NCT01177384|E2|Reported Event|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
668042|NCT01177384|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
668043|NCT01177410|B4|Baseline|Total|Total of all reporting groups
668044|NCT01177410|B3|Baseline|Placebo|Placebo : placebo capsules once daily for 12 weeks
668045|NCT01177410|B2|Baseline|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
668046|NCT01177410|B1|Baseline|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
668047|NCT01177410|P3|Participant Flow|Placebo|Placebo : placebo capsules once daily for 12 weeks
668048|NCT01177410|P2|Participant Flow|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
668049|NCT01177410|P1|Participant Flow|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
668050|NCT01177410|O3|Outcome|Placebo|Placebo : placebo capsules once daily for 12 weeks
668051|NCT01177410|O2|Outcome|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
668052|NCT01177410|O1|Outcome|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
668053|NCT01177410|O3|Outcome|Placebo|Placebo : placebo capsules once daily for 12 weeks
668054|NCT01177410|O2|Outcome|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
668055|NCT01177410|O1|Outcome|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
668056|NCT01177410|E3|Reported Event|Placebo|Placebo : placebo capsules once daily for 12 weeks
668057|NCT01177410|E2|Reported Event|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
668058|NCT01177410|E1|Reported Event|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
668059|NCT01177553|B3|Baseline|Total|Total of all reporting groups
668171|NCT01177943|B1|Baseline|Atomoxetine Oral Solution First, Then Capsule Formulation|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
668172|NCT01177943|P2|Participant Flow|Atomoxetine Capsule Formulation First, Then Oral Solution|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
668060|NCT01177553|B2|Baseline|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient’s perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
668061|NCT01177553|B1|Baseline|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.
Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
668062|NCT01177553|P2|Participant Flow|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
668063|NCT01177553|P1|Participant Flow|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.
Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
668064|NCT01177553|O2|Outcome|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
668065|NCT01177553|O1|Outcome|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.
Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
668066|NCT01177553|E2|Reported Event|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
668067|NCT01177553|E1|Reported Event|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.
Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
668068|NCT01177670|B1|Baseline|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
668069|NCT01177670|P1|Participant Flow|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
668070|NCT01177670|O1|Outcome|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
668071|NCT01177670|O1|Outcome|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
668072|NCT01177670|E1|Reported Event|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
668073|NCT01177709|B1|Baseline|Metformin|Metformin: metformin 500- 2500 mg/day.
668074|NCT01177709|P1|Participant Flow|Metformin|Metformin: metformin 500- 2500 mg/day.
668075|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
668076|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
668077|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
668078|NCT01177709|E1|Reported Event|Metformin|Metformin: metformin 500- 2500 mg/day.
668079|NCT01177722|B5|Baseline|Total|Total of all reporting groups
668080|NCT01177722|B4|Baseline|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668081|NCT01177722|B3|Baseline|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668082|NCT01177722|B2|Baseline|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668292|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
668083|NCT01177722|B1|Baseline|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668084|NCT01177722|P4|Participant Flow|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668085|NCT01177722|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668086|NCT01177722|P2|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668087|NCT01177722|P1|Participant Flow|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668088|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668089|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668090|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668091|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668092|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668093|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668094|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668095|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668096|NCT01177722|O4|Outcome|Infanrix Hexa™|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668293|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
668097|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668098|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668099|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668100|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668101|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668102|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668103|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668104|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668105|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668106|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668107|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668108|NCT01177722|E4|Reported Event|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668109|NCT01177722|E3|Reported Event|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668128|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
668110|NCT01177722|E2|Reported Event|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668111|NCT01177722|E1|Reported Event|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
668112|NCT01177735|B1|Baseline|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
668113|NCT01177735|P1|Participant Flow|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
668114|NCT01177735|O1|Outcome|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
668115|NCT01177735|E1|Reported Event|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
668116|NCT01177800|B3|Baseline|Total|Total of all reporting groups
668117|NCT01177800|B2|Baseline|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
668118|NCT01177800|B1|Baseline|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
668119|NCT01177800|P2|Participant Flow|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
668120|NCT01177800|P1|Participant Flow|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
668121|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
668122|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
668123|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
668124|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
668125|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
668126|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
668127|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
668129|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
668294|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668130|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
668131|NCT01177800|E2|Reported Event|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
668132|NCT01177800|E1|Reported Event|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
668133|NCT01177813|B6|Baseline|Total|Total of all reporting groups
668134|NCT01177813|B5|Baseline|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
668135|NCT01177813|B4|Baseline|Sitagliptin 100|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
668136|NCT01177813|B3|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
668137|NCT01177813|B2|Baseline|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
668138|NCT01177813|B1|Baseline|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
668139|NCT01177813|P5|Participant Flow|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
668140|NCT01177813|P4|Participant Flow|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
668141|NCT01177813|P3|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
668142|NCT01177813|P2|Participant Flow|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
668143|NCT01177813|P1|Participant Flow|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
668144|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
668145|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
668146|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
668147|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
668148|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
668149|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
668150|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
668151|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
668152|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
668153|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
668154|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
668155|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
668156|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
668157|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
668158|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
668159|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
668160|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
668161|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
668162|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
668163|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
668164|NCT01177813|E5|Reported Event|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
668165|NCT01177813|E4|Reported Event|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
668166|NCT01177813|E3|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
668167|NCT01177813|E2|Reported Event|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
668168|NCT01177813|E1|Reported Event|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
668169|NCT01177943|B3|Baseline|Total|Total of all reporting groups
668170|NCT01177943|B2|Baseline|Atomoxetine Capsule Followed by Oral Solution|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
668295|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
668173|NCT01177943|P1|Participant Flow|Atomoxetine Oral Solution First, Then Capsule Formulation|Participants received 50 milligrams (mg) of atomoxetine orally (po), once (12.5 milliliters [mL] at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
668174|NCT01177943|O2|Outcome|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
668175|NCT01177943|O1|Outcome|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
668176|NCT01177943|O2|Outcome|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
668177|NCT01177943|O1|Outcome|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
668178|NCT01177943|E2|Reported Event|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
668179|NCT01177943|E1|Reported Event|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
668180|NCT01177956|B1|Baseline|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
668181|NCT01177956|P1|Participant Flow|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
668182|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
668183|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
668184|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
668185|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
668186|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
668187|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
668188|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
668189|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
668190|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
668191|NCT01177956|E2|Reported Event|Cetuximab + Cisplatin + 5-FU : Late Phase|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. Participants with end of treatment date after the last trial treatment date + 30 days or still on trial at the cut-off date.
668192|NCT01177956|E1|Reported Event|Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. On or after the first dosing day of trial treatment and until 30 days after the last trial treatment administration.
668193|NCT01177969|B3|Baseline|Total|Total of all reporting groups
668194|NCT01177969|B2|Baseline|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.
Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
668195|NCT01177969|B1|Baseline|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.
Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
668196|NCT01177969|P2|Participant Flow|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.
Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
668197|NCT01177969|P1|Participant Flow|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.
Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
668198|NCT01177969|O2|Outcome|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.
Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
668199|NCT01177969|O1|Outcome|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.
Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
668200|NCT01177969|O2|Outcome|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.
Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
668201|NCT01177969|O1|Outcome|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.
Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
668202|NCT01177969|E2|Reported Event|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.
Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
668203|NCT01177969|E1|Reported Event|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.
Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
668204|NCT01178073|B4|Baseline|Total|Total of all reporting groups
668205|NCT01178073|B3|Baseline|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
668296|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
668206|NCT01178073|B2|Baseline|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668207|NCT01178073|B1|Baseline|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668208|NCT01178073|P3|Participant Flow|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
668209|NCT01178073|P2|Participant Flow|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668210|NCT01178073|P1|Participant Flow|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668211|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
668212|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668213|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668214|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668215|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
668216|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668217|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668218|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668219|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
668220|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668221|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668222|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668223|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
668224|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668225|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668226|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668227|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
668228|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668229|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668230|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668231|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
668232|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668233|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668234|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668235|NCT01178073|E3|Reported Event|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
668236|NCT01178073|E2|Reported Event|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668237|NCT01178073|E1|Reported Event|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
668238|NCT01178099|B5|Baseline|Total|Total of all reporting groups
668239|NCT01178099|B4|Baseline|Prasugrel 10 mg SD; 7.5 mg MD (Sickle Cell Disease)|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668240|NCT01178099|B3|Baseline|Prasugrel 10 mg SD; 5 mg MD (Sickle Cell Disease)|Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (MD).
668241|NCT01178099|B2|Baseline|Prasugrel 10 mg SD; 7.5 mg MD (Healthy)|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668242|NCT01178099|B1|Baseline|Prasugrel 10 mg SD; 5 mg MD (Healthy)|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]).
668243|NCT01178099|P2|Participant Flow|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668244|NCT01178099|P1|Participant Flow|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668245|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668246|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668247|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668248|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668249|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668250|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668251|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668252|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668253|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668254|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668255|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668256|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668257|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668258|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668259|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668297|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668260|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668261|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668262|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668263|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668264|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668265|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668266|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668267|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668268|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668269|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668270|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668271|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668272|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668273|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668274|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
668275|NCT01178099|E6|Reported Event|All Prasugrel Sickle Cell Disease Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668276|NCT01178099|E5|Reported Event|Prasugrel 10/7.5 mg Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668277|NCT01178099|E4|Reported Event|Prasugrel 10/5 mg Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kg) for an additional 11 days (MD).
668278|NCT01178099|E3|Reported Event|All Prasugrel Healthy Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668279|NCT01178099|E2|Reported Event|Prasugrel 10/7.5 mg Healthy Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
668280|NCT01178099|E1|Reported Event|Prasugrel 10/5 mg Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]).
668281|NCT01178125|B1|Baseline|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668282|NCT01178125|P1|Participant Flow|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668283|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668284|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668285|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668286|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668287|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668288|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668289|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
668290|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
668291|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668298|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
668299|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
668300|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668301|NCT01178125|O2|Outcome|DR-102: Endpoint|at Week 51 of treatment with desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668302|NCT01178125|O1|Outcome|DR-102: Baseline|prior to starting desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668303|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668304|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
668305|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
668306|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668307|NCT01178125|E1|Reported Event|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
668308|NCT01178138|B1|Baseline|Prazosin Effects on Methamphetamine|"The order of placebo vs. active medication will be randomized.
oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo.
General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine.
Session 1 (Monday) Sessions 2 – 6 (Wed, Fri, Mon, Wed, Fri).
Oral placebo + methamphetamine (0, 15, 15 mg/70 kg)
Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg)
Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg)
Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg)
Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg)
Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)"
668309|NCT01178138|P1|Participant Flow|Prazosin Effects on Methamphetamine|"Double blind, placebo controlled study of the effect of prazosin on methamphetamine
The order of placebo vs. active medication will be randomized.
oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo.
General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine.
Session 1 (Monday) Sessions 2 - 6 (Wed, Fri, Mon, Wed, Fri).
Oral placebo + methamphetamine (0, 15, 15 mg/70 kg) Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg) Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)"
668310|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
668311|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
668312|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
668313|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
668314|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
668315|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
668316|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
668317|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
668318|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
668319|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
668320|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
668321|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
668322|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
668323|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
668324|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
668325|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
668326|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
668327|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
668328|NCT01178138|E1|Reported Event|Prazosin Effects on Methamphetamine|Randomized placebo controlled trial of prazosin effects on methamphetamine
668329|NCT01178268|B3|Baseline|Total|Total of all reporting groups
668330|NCT01178268|B2|Baseline|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668331|NCT01178268|B1|Baseline|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668332|NCT01178268|P2|Participant Flow|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668333|NCT01178268|P1|Participant Flow|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668334|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668335|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668336|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668337|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668338|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668339|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668340|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668341|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668342|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668343|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668344|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668345|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668346|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668347|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668348|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668349|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668350|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668351|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668352|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668353|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668354|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668355|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668356|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668357|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668358|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668359|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668360|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668361|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668362|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668363|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668364|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668365|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668366|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668367|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668368|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668369|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668370|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668371|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668372|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668373|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668374|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668375|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668376|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668377|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668378|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668379|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668380|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668381|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668382|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668383|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668384|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668385|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668386|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668387|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668388|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668389|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668390|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668391|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668392|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668393|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668394|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668395|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668396|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668397|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668398|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668399|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668400|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668401|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668402|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668403|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668404|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668405|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668406|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668407|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668408|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668409|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668410|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668411|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668412|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668413|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668414|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668415|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668416|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668417|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668418|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668419|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668420|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668421|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668422|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668423|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668424|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668425|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668426|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668427|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668428|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668429|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668431|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668432|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668433|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668434|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668435|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668436|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668437|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668438|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668439|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668440|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668441|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668442|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668443|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668444|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668445|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668446|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668447|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668448|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668449|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668450|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668451|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668452|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668453|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668454|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668455|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668456|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668457|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668458|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668459|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668460|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668461|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668462|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668463|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668464|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668465|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668466|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668467|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668468|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668469|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668470|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668471|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668472|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668473|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668474|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668475|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668476|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668477|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668478|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668479|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668480|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668481|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668482|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668483|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668484|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668485|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668486|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668487|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668488|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668489|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668490|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668491|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668492|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668493|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668494|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668495|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668496|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668497|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668498|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668499|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668500|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668501|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668502|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668503|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668504|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668505|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668506|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668507|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668508|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668509|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668510|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668511|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668512|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668513|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668514|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668515|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668516|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668517|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668518|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668519|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668520|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668521|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668522|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668523|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668524|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668525|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668526|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668527|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668528|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668529|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668530|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668531|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668532|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668533|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668534|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668535|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668536|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668537|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668538|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668539|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668540|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668541|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668542|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668543|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668544|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668545|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668546|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668547|NCT01178268|E2|Reported Event|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.
CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
668548|NCT01178268|E1|Reported Event|XIENCE V EECSS|"Patients who will receive this stent.
XIENCE V EECSS: Patients who will receive this stent."
668549|NCT01178281|B3|Baseline|Total|Total of all reporting groups
668550|NCT01178281|B2|Baseline|Placebo (Oral Capsule)|Matching oral placebo Days 1 through Day 168
668551|NCT01178281|B1|Baseline|Pomalidomide 0.5 mg (Oral Capsule)|Pomalidomide 0.5 mg by mouth daily Days 1 through Day 168
668552|NCT01178281|P2|Participant Flow|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
668553|NCT01178281|P1|Participant Flow|Pomalidomide 0.5 mg (Oral Capsule)|Pomalidomide 0.5 mg by mouth daily Days 1 through Day 168
668554|NCT01178281|O2|Outcome|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
668555|NCT01178281|O1|Outcome|Pomalidomide 0.5mg (Oral Capsule)|Pomalidomide 0.5mg by mouth daily Days 1 through Day 168
668556|NCT01178281|E2|Reported Event|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
668557|NCT01178281|E1|Reported Event|Pomalidomide 0.5mg (Oral Capsule)|Pomalidomide 0.5mg by mouth daily Days 1 through Day 168
668558|NCT01178294|B1|Baseline|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668559|NCT01178294|P1|Participant Flow|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668560|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668561|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668562|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668563|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668564|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668565|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668566|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668567|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668568|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668569|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668570|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668571|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668572|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668573|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668574|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668575|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668576|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668577|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668578|NCT01178294|E1|Reported Event|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
668579|NCT01178333|B4|Baseline|Total|Total of all reporting groups
668580|NCT01178333|B3|Baseline|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668581|NCT01178333|B2|Baseline|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668582|NCT01178333|B1|Baseline|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668583|NCT01178333|P3|Participant Flow|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668584|NCT01178333|P2|Participant Flow|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668585|NCT01178333|P1|Participant Flow|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668586|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668587|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668588|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668589|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668590|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668591|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668592|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668593|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668594|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668595|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668596|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668597|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668598|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668599|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668600|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668601|NCT01178333|O2|Outcome|OD Result >= 1.0|Heparin-PF4 OD Test Results >= 1.0
668602|NCT01178333|O1|Outcome|OD Result < 1.0|Heparin-PF4 OD Test Results < 1.0
668603|NCT01178333|O2|Outcome|OD Result >= 1.0|Heparin-PF4 OD Test Results >= 1.0
668604|NCT01178333|O1|Outcome|OD Result < 1.0|Heparin-PF4 OD Test Results < 1.0
668605|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668606|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668607|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668608|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668609|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668610|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668611|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668612|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668613|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668614|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668615|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668616|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668617|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668618|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668619|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668620|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668621|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668622|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668623|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668624|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668625|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668626|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668627|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668628|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668629|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668630|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668631|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668632|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668633|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668634|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668635|NCT01178333|E3|Reported Event|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
668636|NCT01178333|E2|Reported Event|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
668637|NCT01178333|E1|Reported Event|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
668638|NCT01178385|B3|Baseline|Total|Total of all reporting groups
668639|NCT01178385|B2|Baseline|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
668640|NCT01178385|B1|Baseline|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
668641|NCT01178385|P2|Participant Flow|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
668642|NCT01178385|P1|Participant Flow|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
668643|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
668644|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
668775|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
668645|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
668646|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
668647|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
668648|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
668649|NCT01178385|E2|Reported Event|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
668650|NCT01178385|E1|Reported Event|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
668651|NCT01178528|B4|Baseline|Total|Total of all reporting groups
668652|NCT01178528|B3|Baseline|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
668653|NCT01178528|B2|Baseline|Carvedilol|up to 25 mg b.i.d.
668654|NCT01178528|B1|Baseline|Ivabradine|up to 7.5 mg b.i.d.
668655|NCT01178528|P3|Participant Flow|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
668656|NCT01178528|P2|Participant Flow|Carvedilol|up to 25 mg b.i.d.
668657|NCT01178528|P1|Participant Flow|Ivabradine|up to 7.5 mg b.i.d.
668658|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
668659|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
668660|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
668661|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
668662|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
668663|NCT01178528|O1|Outcome|Ivabradine|7.5 mg b.i.d.
668664|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
668665|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
668666|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
668667|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
668668|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
668669|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
668670|NCT01178528|E3|Reported Event|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
668671|NCT01178528|E2|Reported Event|Carvedilol|up to 25 mg b.i.d.
668672|NCT01178528|E1|Reported Event|Ivabradine|up to 7.5 mg b.i.d.
668673|NCT01178671|B3|Baseline|Total|Total of all reporting groups
668674|NCT01178671|B2|Baseline|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668675|NCT01178671|B1|Baseline|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668676|NCT01178671|P2|Participant Flow|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668677|NCT01178671|P1|Participant Flow|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668678|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668679|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668680|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668681|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668682|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668683|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668684|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668685|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668686|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668687|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668688|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668689|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668690|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668691|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668692|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668693|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668694|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668695|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668696|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668697|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668698|NCT01178671|E2|Reported Event|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
668699|NCT01178671|E1|Reported Event|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
668700|NCT01178762|B1|Baseline|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
668701|NCT01178762|P1|Participant Flow|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
668702|NCT01178762|O1|Outcome|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
668703|NCT01178762|E1|Reported Event|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
668704|NCT01178827|B4|Baseline|Total|Total of all reporting groups
668705|NCT01178827|B3|Baseline|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
668706|NCT01178827|B2|Baseline|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
668707|NCT01178827|B1|Baseline|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
668708|NCT01178827|P3|Participant Flow|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
668709|NCT01178827|P2|Participant Flow|Oxybutynin IR|Oxybutynin IR (oxybutynin immediate release) 5 mg, three times daily for 2 days
668710|NCT01178827|P1|Participant Flow|Sanctura XR®|Sanctura XR® (trospium chloride), 60mg once daily for 10 days
668711|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
668712|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
668713|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
668714|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
668715|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
668716|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
668717|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
668718|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
668719|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
668720|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
668721|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
668722|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
668723|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
668724|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
668725|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
668726|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
668727|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
668728|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
668729|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
668730|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
668731|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
668732|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
668733|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
668734|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
668735|NCT01178827|E3|Reported Event|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
668736|NCT01178827|E2|Reported Event|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
668737|NCT01178827|E1|Reported Event|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
668738|NCT01178853|B3|Baseline|Total|Total of all reporting groups
668739|NCT01178853|B2|Baseline|Rosuvastatin/Pitavastatin|
668740|NCT01178853|B1|Baseline|Pitavastatin/Rosuvastatin|
668741|NCT01178853|P2|Participant Flow|Rosuvastatin/Pitavastatin|
668742|NCT01178853|P1|Participant Flow|Pitavastatin/Rosuvastatin|
668743|NCT01178853|O2|Outcome|Warfarin + Rosuvastatin|
668744|NCT01178853|O1|Outcome|Warfarin + Pitavastatin|
668745|NCT01178853|E2|Reported Event|Warfarin + Rosuvastatin|
668746|NCT01178853|E1|Reported Event|Warfarin + Pitavastatin|
668747|NCT01179048|B3|Baseline|Total|Total of all reporting groups
668748|NCT01179048|B2|Baseline|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668749|NCT01179048|B1|Baseline|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668750|NCT01179048|P2|Participant Flow|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668751|NCT01179048|P1|Participant Flow|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668776|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
668777|NCT01179113|E2|Reported Event|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
668752|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668753|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668754|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668755|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668756|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668757|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668758|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668759|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668760|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668761|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668762|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668763|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668764|NCT01179048|E2|Reported Event|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668765|NCT01179048|E1|Reported Event|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
668766|NCT01179113|B3|Baseline|Total|Total of all reporting groups
668767|NCT01179113|B2|Baseline|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
668768|NCT01179113|B1|Baseline|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
668769|NCT01179113|P2|Participant Flow|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
668770|NCT01179113|P1|Participant Flow|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
668771|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
668772|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
668778|NCT01179113|E1|Reported Event|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
668779|NCT01176565|B3|Baseline|Total|Total of all reporting groups
668780|NCT01176565|B2|Baseline|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
668781|NCT01176565|B1|Baseline|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
668782|NCT01176565|P2|Participant Flow|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
668783|NCT01176565|P1|Participant Flow|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater then the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
668784|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
668785|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
668786|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
668806|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
668787|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
668788|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
668789|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
668790|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
668791|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
668792|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
668793|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
668804|NCT02773758|P1|Participant Flow|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
668983|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
668794|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
668795|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
668796|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
668797|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
668798|NCT01176565|E2|Reported Event|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
668799|NCT01176565|E1|Reported Event|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
668800|NCT02773758|B3|Baseline|Total|Total of all reporting groups
668801|NCT02773758|B2|Baseline|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
668802|NCT02773758|B1|Baseline|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
668803|NCT02773758|P2|Participant Flow|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
668805|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
668807|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
668808|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
668809|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
668810|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
668811|NCT02773758|E2|Reported Event|Sodium Monofluorophosphate Dentifrice|Participants were instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
668812|NCT02773758|E1|Reported Event|Stannous Fluoride Dentifrice|Participants were instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
668874|NCT02223364|B4|Baseline|Total|Total of all reporting groups
668875|NCT02223364|B3|Baseline|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668876|NCT02223364|B2|Baseline|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668877|NCT02223364|B1|Baseline|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668878|NCT02223364|P3|Participant Flow|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668879|NCT02223364|P2|Participant Flow|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668880|NCT02223364|P1|Participant Flow|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668881|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668882|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668883|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668984|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
668986|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
668990|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
668991|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
668884|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668885|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668886|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668887|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668888|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668889|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668890|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668891|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668892|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668893|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668894|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668895|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668896|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668987|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
668992|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
668993|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
668897|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668898|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668899|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668900|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668901|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668902|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668903|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668904|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668905|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668906|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668907|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668908|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668909|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668910|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668988|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
668911|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668912|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668913|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668914|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668915|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668916|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668917|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668918|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668919|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668920|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668921|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668922|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668923|NCT02223364|O3|Outcome|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668989|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
668994|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
668924|NCT02223364|O2|Outcome|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668925|NCT02223364|O1|Outcome|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668926|NCT02223364|E3|Reported Event|Liposomal Bupivacaine (PAI-L)|This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668927|NCT02223364|E2|Reported Event|Ropivacaine (PAI-R)|This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
668928|NCT02223364|E1|Reported Event|Peripheral Nerve Block (PNB)|This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
668985|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
668959|NCT02116582|B1|Baseline|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
668960|NCT02116582|P1|Participant Flow|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
668961|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
668962|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
668963|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
668964|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
668965|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
668966|NCT02116582|E1|Reported Event|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
668967|NCT01262560|B4|Baseline|Total|Total of all reporting groups
668968|NCT01262560|B3|Baseline|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
668969|NCT01262560|B2|Baseline|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
668970|NCT01262560|B1|Baseline|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
668971|NCT01262560|P3|Participant Flow|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
668972|NCT01262560|P2|Participant Flow|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
668973|NCT01262560|P1|Participant Flow|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
668974|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
668975|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
668976|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
668977|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
668978|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
668979|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
668980|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
668981|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
668982|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
668995|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
668996|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
668997|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
668998|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
668999|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
669000|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
669001|NCT01262560|O3|Outcome|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
669002|NCT01262560|O2|Outcome|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
669003|NCT01262560|O1|Outcome|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
669004|NCT01262560|E3|Reported Event|Lozenge Manuka Honey|Manuka honey in lozenge form during concurrent chemotherapy and radiation treatment.
669005|NCT01262560|E2|Reported Event|Liquid Manuka Honey|Manuka honey in liquid form during concurrent chemotherapy and radiation treatment.
669006|NCT01262560|E1|Reported Event|Supportive Care|Standard supportive care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment.
669012|NCT00670631|B1|Baseline|Tandem Autologous Stem Cell Transplant|"Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days."
669013|NCT00670631|P1|Participant Flow|Tandem Autologous Stem Cell Transplant|"Induction: DPACE chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days."
669014|NCT00670631|O1|Outcome|Tandem Autologous Stem Cell Transplant|"Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days.
Transplant 1: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.
Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Transplant 2: 8 weeks to 6 months after the first transplant, participants will have the second transplant Maintenance: Year 1- VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles."
669015|NCT00670631|O1|Outcome|Tandem Autologous Stem Cell Transplant|"Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days.
Transplant 1: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.
Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Transplant 2: 8 weeks to 6 months after the first transplant, participants will have the second transplant Maintenance: Year 1- VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles."
669016|NCT00670631|O1|Outcome|Tandem Autologous Stem Cell Transplant|"Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days.
Transplant 1: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.
Once recovered, participants start thalidomide daily & dexamethasone x 4 days every 21 days.
Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Transplant 2: 8 weeks to 6 months after the first transplant, participants will have the second transplant Maintenance: Year 1- VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.
tandem autologous transplantation: DPACE: dexamethasone 20 mg days 1-4 and 8-11, cisplatin 10 mg/m2 days 1-4, Adriamycin 10 mg/m2 days"
669078|NCT02283268|O3|Outcome|Major Surgery|All participants who underwent major surgery.
669079|NCT02283268|O2|Outcome|Minor Surgery|All participants who underwent minor surgery.
669017|NCT00670631|E1|Reported Event|Tandem Autologous Stem Cell Transplant|"Induction: DPACE chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days."
669030|NCT02283268|B1|Baseline|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669031|NCT02283268|P1|Participant Flow|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669032|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669033|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669034|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669035|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669036|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669037|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669038|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669039|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669040|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669041|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669042|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669043|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669044|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669045|NCT02283268|O9|Outcome|Von Willebrand Disease Type 3|All participants with von Willebrand Disease Type 3.
669046|NCT02283268|O8|Outcome|Von Willebrand Disease Type 2M|All participants with von Willebrand Disease Type 2M.
669047|NCT02283268|O7|Outcome|Von Willebrand Disease Type 2B|All participants with von Willebrand Disease Type 2B.
669048|NCT02283268|O6|Outcome|Von Willebrand Disease Type 2A|All participants with von Willebrand Disease Type 2A.
669049|NCT02283268|O5|Outcome|Von Willebrand Disease Type 1|All participants with von Willebrand Disease Type 1.
669050|NCT02283268|O4|Outcome|Oral Surgery|All participants who underwent oral surgery.
669051|NCT02283268|O3|Outcome|Major Surgery|All participants who underwent major surgery.
669052|NCT02283268|O2|Outcome|Minor Surgery|All participants who underwent minor surgery.
669053|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669054|NCT02283268|O9|Outcome|Von Willebrand Disease Type 3|All participants with von Willebrand Disease Type 3.
669055|NCT02283268|O8|Outcome|Von Willebrand Disease Type 2M|All participants with von Willebrand Disease Type 2M.
669056|NCT02283268|O7|Outcome|Von Willebrand Disease Type 2B|All participants with von Willebrand Disease Type 2B.
669057|NCT02283268|O6|Outcome|Von Willebrand Disease Type 2A|All participants with von Willebrand Disease Type 2A.
669058|NCT02283268|O5|Outcome|Von Willebrand Disease Type 1|All participants with von Willebrand Disease Type 1.
669059|NCT02283268|O4|Outcome|Oral Surgery|All participants who underwent oral surgery.
669060|NCT02283268|O3|Outcome|Major Surgery|All participants who underwent major surgery.
669061|NCT02283268|O2|Outcome|Minor Surgery|All participants who underwent minor surgery.
669062|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669063|NCT02283268|O9|Outcome|Von Willebrand Disease Type 3|All participants with von Willebrand Disease Type 3.
669064|NCT02283268|O8|Outcome|Von Willebrand Disease Type 2M|All participants with von Willebrand Disease Type 2M.
669065|NCT02283268|O7|Outcome|Von Willebrand Disease Type 2B|All participants with von Willebrand Disease Type 2B.
669066|NCT02283268|O6|Outcome|Von Willebrand Disease Type 2A|All participants with von Willebrand Disease Type 2A.
669067|NCT02283268|O5|Outcome|Von Willebrand Disease Type 1|All participants with von Willebrand Disease Type 1.
669068|NCT02283268|O4|Outcome|Oral Surgery|All participants who underwent oral surgery.
669069|NCT02283268|O3|Outcome|Major Surgery|All participants who underwent major surgery.
669070|NCT02283268|O2|Outcome|Minor Surgery|All participants who underwent minor surgery.
669071|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669072|NCT02283268|O9|Outcome|Von Willebrand Disease Type 3|All participants with von Willebrand Disease Type 3.
669073|NCT02283268|O8|Outcome|Von Willebrand Disease Type 2M|All participants with von Willebrand Disease Type 2M.
669074|NCT02283268|O7|Outcome|Von Willebrand Disease Type 2B|All participants with von Willebrand Disease Type 2B.
669075|NCT02283268|O6|Outcome|Von Willebrand Disease Type 2A|All participants with von Willebrand Disease Type 2A.
669076|NCT02283268|O5|Outcome|Von Willebrand Disease Type 1|All participants with von Willebrand Disease Type 1.
669077|NCT02283268|O4|Outcome|Oral Surgery|All participants who underwent oral surgery.
669080|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669081|NCT02283268|O9|Outcome|Von Willebrand Disease Type 3|All participants with von Willebrand Disease Type 3.
669082|NCT02283268|O8|Outcome|Von Willebrand Disease Type 2M|All participants with von Willebrand Disease Type 2M.
669083|NCT02283268|O7|Outcome|Von Willebrand Disease Type 2B|All participants with von Willebrand Disease Type 2B.
669084|NCT02283268|O6|Outcome|Von Willebrand Disease Type 2A|All participants with von Willebrand Disease Type 2A.
669085|NCT02283268|O5|Outcome|Von Willebrand Disease Type 1|All participants with von Willebrand Disease Type 1.
669086|NCT02283268|O4|Outcome|Oral Surgery|All participants who underwent oral surgery.
669087|NCT02283268|O3|Outcome|Major Surgery|All participants who underwent major surgery.
669088|NCT02283268|O2|Outcome|Minor Surgery|All participants who underwent minor surgery.
669089|NCT02283268|O1|Outcome|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669090|NCT02283268|E1|Reported Event|Recombinant Von Willebrand Factor (rVWF)|Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
669091|NCT02154425|B1|Baseline|Mothers (SS)|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
669092|NCT02154425|P1|Participant Flow|Mothers (SS)|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
669093|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
669094|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
669095|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
669096|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
669097|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
669098|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
669099|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
669100|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
669101|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
669102|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
669103|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
669104|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
669105|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
669106|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
669107|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
669108|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
669109|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
669110|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
669111|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
669112|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
669113|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
669114|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
669115|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
669116|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
669117|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
669118|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
669119|NCT02154425|E2|Reported Event|SS-I|This arm consisted of all infants of mothers in the SS-M.
669120|NCT02154425|E1|Reported Event|SS-M|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
669156|NCT01163461|B1|Baseline|Behavioral Aphasia Therapy|Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
669157|NCT01163461|P2|Participant Flow|Immediate Aphasia Therapy|14 individuals were randomized to received 60 hours of aphasia therapy immediately following testing. (no delay)
669158|NCT01163461|P1|Participant Flow|Delayed Aphasia Therapy|14 individuals were randomized to received aphasia therapy following a 6-week control delay phase. Upon completion of the 6-week control phase, they received 60 hours of behavioral therapy
669159|NCT01163461|O1|Outcome|Behavioral Aphasia Therapy|Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
669160|NCT01163461|E1|Reported Event|Single Group Open Trial|28 individuals were randomized to receive either immediate speech therapy, or delayed speech therapy (following a 6 week delay period to control for Hawthorne effects). All participants received 60 hours of speech therapy 2 hours/day, 5 days/week for 6 weeks. Language behaviors were testing before, after and 3 months later.
669245|NCT01793883|B2|Baseline|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir
80 mg Laninamivir Octanoate"
669214|NCT00641641|B1|Baseline|Drug Intervention|Tenofovir+emtricitabine+raltegravir
669215|NCT00641641|P1|Participant Flow|Drug Intervention|Tenofovir+emtricitabine+raltegravir
669216|NCT00641641|O1|Outcome|Drug Intervention|Tenofovir+emtricitabine+raltegravir
669217|NCT00641641|E1|Reported Event|Drug Intervention|Tenofovir+emtricitabine+raltegravir
669218|NCT00407888|B1|Baseline|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
filgrastim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
trastuzumab: Given IV
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies"
669219|NCT00407888|P1|Participant Flow|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
filgrastim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
trastuzumab: Given IV
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies"
669220|NCT00407888|O1|Outcome|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
filgrastim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
trastuzumab: Given IV
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies"
669221|NCT00407888|O1|Outcome|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
filgrastim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
trastuzumab: Given IV
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies"
669222|NCT00407888|O1|Outcome|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
filgrastim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
trastuzumab: Given IV
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies"
669223|NCT00407888|O1|Outcome|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
filgrastim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
trastuzumab: Given IV
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies"
669265|NCT01244893|B1|Baseline|All Subjects|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.
669266|NCT01244893|P2|Participant Flow|Acuvue Advance Plus postQ/Acuvue Advance Plus preQ|"Arm 1:
Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn second.
Arm 2:
Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn second."
669224|NCT00407888|O1|Outcome|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
filgrastim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
trastuzumab: Given IV
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies"
669225|NCT00407888|E1|Reported Event|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
filgrastim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
trastuzumab: Given IV
laboratory biomarker analysis: Correlative studies
quality-of-life assessment: Ancillary studies"
669226|NCT00127660|B5|Baseline|Total|Total of all reporting groups
669227|NCT00127660|B4|Baseline|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
669228|NCT00127660|B3|Baseline|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
669229|NCT00127660|B2|Baseline|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
669230|NCT00127660|B1|Baseline|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
669231|NCT00127660|P4|Participant Flow|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
669232|NCT00127660|P3|Participant Flow|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
669233|NCT00127660|P2|Participant Flow|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
669234|NCT00127660|P1|Participant Flow|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
669235|NCT00127660|O4|Outcome|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
669236|NCT00127660|O3|Outcome|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
669237|NCT00127660|O2|Outcome|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
669238|NCT00127660|O1|Outcome|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
669239|NCT00127660|E4|Reported Event|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
669240|NCT00127660|E3|Reported Event|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
669241|NCT00127660|E2|Reported Event|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
669242|NCT00127660|E1|Reported Event|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
669243|NCT01793883|B4|Baseline|Total|Total of all reporting groups
669244|NCT01793883|B3|Baseline|Placebo|"Matching Placebo
Placebo"
669246|NCT01793883|B1|Baseline|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo
40 mg Laninamivir Octanoate
Placebo"
669247|NCT01793883|P3|Participant Flow|Placebo|"Matching Placebo
Placebo"
669248|NCT01793883|P2|Participant Flow|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir
80 mg Laninamivir Octanoate"
669249|NCT01793883|P1|Participant Flow|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo
40 mg Laninamivir Octanoate
Placebo"
669250|NCT01793883|O3|Outcome|Placebo|"Matching Placebo
Placebo"
669251|NCT01793883|O2|Outcome|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir
80 mg Laninamivir Octanoate"
669252|NCT01793883|O1|Outcome|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo
40 mg Laninamivir Octanoate
Placebo"
669253|NCT01793883|E3|Reported Event|Placebo|"Matching Placebo
Placebo"
669254|NCT01793883|E2|Reported Event|80 mg Laninamivir Octanoate DPI|"80 mg Laninamivir Octanoate
80 mg Laninamivir Octanoate"
669255|NCT01793883|E1|Reported Event|40 mg Laninamivir Octanoate DPI|"40 mg Laninamivir Octanoate and matching placebo
40 mg Laninamivir Octanoate
Placebo"
669256|NCT01268553|B1|Baseline|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
669257|NCT01268553|P1|Participant Flow|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
669258|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
669259|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
669260|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
669261|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
669262|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
669263|NCT01268553|O1|Outcome|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
669264|NCT01268553|E1|Reported Event|Open Label Single Arm Group|World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids
669267|NCT01244893|P1|Participant Flow|Acuvue Advance Plus preQ/Acuvue Advance Plus postQ|"Arm 1:
Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.
Arm 2:
Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn second."
669268|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-9 days.
669269|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-9 days.
669270|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days.
669271|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days.
669272|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post to qualification were worn daily for 6-8 days.
669273|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days.
669274|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days. Binocular measurements reported only.
669275|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days. Binocular measurements reported only.
669276|NCT01244893|E2|Reported Event|AAP PostQ|Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.
669277|NCT01244893|E1|Reported Event|AAP PreQ|Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.
669278|NCT01000493|B3|Baseline|Total|Total of all reporting groups
669279|NCT01000493|B2|Baseline|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669280|NCT01000493|B1|Baseline|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669281|NCT01000493|P2|Participant Flow|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669282|NCT01000493|P1|Participant Flow|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669283|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669284|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669285|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669286|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669287|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669288|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669289|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669290|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669291|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669292|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669293|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669294|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669295|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669296|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669297|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669298|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669299|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669300|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669301|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669302|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669303|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669304|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669305|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669306|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669307|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669308|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669309|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669310|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669311|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669312|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669313|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669314|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669315|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669316|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669317|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669318|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669319|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669320|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669321|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669322|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669323|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669324|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669325|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669326|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669327|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669328|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
669329|NCT01000493|E2|Reported Event|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
669330|NCT01000493|E1|Reported Event|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
